Us 11166703

US011166703B2
( 12 ) Kassab
Unitedet alStates
.
Patent ( 10) Patent No .: US 11,166,703 B2
(45 ) Date of Patent : Nov. 9 , 2021
( 54 ) DEVICES , SYSTEMS , AND METHODS FOR 25/007 ; A61M 25/1002 ; A61M 25/1011 ;
ATRIAL APPENDAGE OCCLUSION USING A61M 25/1013 ; A61M 25/1015 ; A61B
LIGHT CURE 17/00491; A61B 17/0057 ;
(Continued )
( 71 ) Applicant: CVDevices , LLC , San Diego , CA (US)
( 56 ) References Cited
( 72 ) Inventors: Ghassan S. Kassab , La Jolla , CA (US ); U.S. PATENT DOCUMENTS
Jose A. Navia , Sr., Buenos Aires (AR )
( 73 ) Assignee: CVDevices, LLC , San Diego, CA ( US ) 6,152,144 A 11/2000 Lesh et al .
6,315,709 B1 11/2001 Garibaldi et al .
( * ) Notice: Subject to any disclaimer, the term of this (Continued )
patent is extended or adjusted under 35
U.S.C. 154 ( b) by 0 days. OTHER PUBLICATIONS
( 21 ) Appl. No .: 14 /991,322 International Searching Authority, International Search Report, PCT /
US2009 /030222 , dated Feb. 24 , 2009 .
(22 ) Filed : Jan. 8 , 2016 ( Continued )
( 65 ) Prior Publication Data Primary Examiner Diane D Yabut
Assistant Examiner Christian D Knauss
US 2016/0192912 A1 Jul . 7 , 2016 (74 ) Attorney , Agent, or Firm — Reichel Stohry Dean
Related U.S. Application Data LLP ; Mark C. Reichel ; Natalie Dean
( 63 ) Continuation - in - part of application No. 14 / 991,274 , ( 57 ) ABSTRACT
filed on Jan. 8 , 2016 , now abandoned , and a Atrial appendage occlusion devices and methods of using
( Continued ) the same that employ the application of light having a
desired wavelength range . The devices of the present dis
(51 ) Int. Ci. closure comprise a telescoping catheter assembly coupled
A61B 17/00 ( 2006.01 ) with an adhesive delivery device and a suction source , and
A61B 17/12 (2006.01 ) comprise at least one optical fiber disposed therein . The
(Continued ) catheter assembly is configured to isolate an atrial append
(52) U.S. CI. age cavity, deliver suction and adhesive thereto , and, using
CPC A61B 17/0057 (2013.01 ) ; A61B 17/00491 the optical fiber ( s ), cure the adhesive present within the
( 2013.01 ) ; A61B 17/12013 ( 2013.01 ) ; cavity all without withdrawing any components of the
( Continued ) catheter assembly from the body. Methods for using such
device in the treatment of atrial appendage occlusion are
( 58 ) Field of Classification Search also provided.
CPC .. A61M 2025/1052 ; A61M 2025/1059 ; A61M
2025/1072 ; A61M 2025/1093 ; A61M 18 Claims , 38 Drawing Sheets
50
14b
LAA
14a
16
60 12
36
#
cure light
US 11,166,703 B2
Page 2
Related U.S. Application Data 202570086 (2013.01 ) ; A61M 2025/0096

continuation - in - part of application No. 13 / 937,867 , ( 2013.01 ) ; A61M 2025/0681 ( 2013.01 ) ; A61M
filed on Jul . 9 , 2013 , now Pat. No. 10,772,636 , which 2025/1052 ( 2013.01 )
is a continuation of application No. 12 / 863,540 , filed ( 58 ) Field of Classification Search
as application No. PCT /US2009 /030222 on Jan. 6 , CPC A61B 17/12022 ; A61B 17/12122 ; A61B
2009 , now Pat . No. 8,480,708 , which is a continu 2017/005 ; A61B 2017/00632 ; A61B
ation - in - part of application No. PCT /US2008 / 2017/0065 , A61B 2017/22067 ; A61B
000838 , filed on Jan. 23 , 2008 , application No. 2017/306 ; A61B 1/00165 ; A61B
14/ 991,322 , which is a continuation -in -part of appli 2018/1807 ; A61B 2218/007 ; A61B
cation No. 14 /338,031 , filed aon Jul . 22 , 2014 , now 17/00243
Pat. No. 9,717,488 , which is a continuation of appli USPC 606/200 , 213–217 ; 604 / 101.01 , 101.05
cation No. 13 / 537,394 , filed on Jun . 29 , 2012 , now See application file for complete search history .
Pat. No. 8,784,469 , application No. 14 / 991,322 ,
which is a continuation - in -part of application No. ( 56 ) References Cited
14/ 177,803 , filed on Feb. 11 , 2014 , now Pat. No.
9,566,073 , which is aa continuation of application No. U.S. PATENT DOCUMENTS
12/ 522,674 , filed as application No. PCT /US2008 / 6,919,067 B2 7/2005 Filler et al .
000838 on Jan. 23 , 2008 , now Pat . No. 8,647,367 ,
2
7,918,865 B2 4/2011 Liddicoat et al.
said application No. 14/ 991,274 is a continuation - in 2003/0060756 Al 3/2003 Hayman et al .
part of application No. 13 / 937,867 , filed on Jul. 9 , 2003/0120337 A1 6/2003 Van Tassel et al .
2013 , now Pat. No. 10,772,636 , and a continuation 2003/0208232 A1 11/2003 Blaeser et al .
in -part of application No. 14/ 338,031 , filed on Jul. 22 , 2004/0122362 A1 * 6/2004 Houser A61B 17/0057
604/ 102.01
2014 , now Pat . No. 9,717,488 , and a continuation 2005/0090861 Al 4/2005 Porter
in -part of application No. 14 / 177,803, filed on Feb. 2005/0096501 Al 5/2005 Stelzer et al .
11 , 2014 , now Pat . No. 9,566,073 . 2006/0009801 A1 1/2006 McGurk et al .
2006/0020271 A1 1/2006 Stewart et al .
( 60 ) Provisional application No. 62/ 101,122 , filed on Jan. 2006/0036284 A1 2/2006 Bleaser et al .
8 , 2015 , provisional application No. 62 / 101,135 , filed 2006/0253129 A1 11/2006 Liddicoat et al.
on Jan. 8 , 2015 , provisional application No. 2007/0149995 A1
2007/0233239 Al
6/2007 Quinn et al .
10/2007 Navia et al.
60 / 881,831, filed on Jan. 23 , 2007 , provisional 2008/0243183 Al 10/2008 Miller et al .
application No. 61 / 503,428 , filed on Jun . 30 , 2011 , 2010/0286718 A1 * 11/2010 Kassab A61B 17/00491
provisional application No. 60 / 881,831, filed on Jan. 606/158
23 , 2007 . 2012/0323270 A1 * 12/2012 Lee A61B 17/0057
606/213
( 51 ) Int . Cl . 2013/0018414 Al * 1/2013 Widomski A61B 17/00491
A61M 25/10 ( 2013.01 ) 606/214
A61B 17/128 2014/0058371 A1 * 2/2014 Krishnan A61B 17/3417
( 2006.01 ) 606/27
A61B 17/122 ( 2006.01 ) 2014/0228877 A1 * 8/2014 Kassab A61B 17/12122
A61B 17/22 (2006.01 ) 606/194
A61M 25/01 ( 2006.01 ) 2014/0379021 A1 * 12/2014 Krishnan A61B 17/12122
A61M 25/00 ( 2006.01 ) 606/194
A61M 25/06 ( 2006.01 ) 2015/0315434 A1 * 11/2015 Steele CO9J 101/08
A61B 17/30 514 /772.1
( 2006.01 ) 2017/0079717 A1 * 3/2017 Walsh A61B 18/24
(52) U.S. Ci.
CPC A61B 17/12022 ( 2013.01 ) ; A61B 17/1227 OTHER PUBLICATIONS
( 2013.01 ) ; A61B 17/1285 ( 2013.01 ) ; A61B
17/12122 (2013.01 ) ; A61B 17/12181 International Searching Authority, Written Opinion of the Interna
( 2013.01 ) ; A61B 17/12186 ( 2013.01 ) ; A61M tional Searching Authority, PCT/US2009 /030222, dated Feb. 24 ,
25/1002 ( 2013.01 ) ; A61B 2017/005 ( 2013.01 ) ; 2009 .
A61B 2017/0065 ( 2013.01 ) ; A61B 2017/00243 International Searching Authority, International Search Report, PCT /
( 2013.01 ) ; A61B 2017/00632 (2013.01 ) ; A61B US2008 /000838 , dated Jul. 8 , 2008 .
2017/00867 ( 2013.01 ) ; A61B 2017/22067 International Searching Authority, Written Opinion of the Interna
(2013.01 ) ; A61B 2017/306 (2013.01 ) ; A61B tional Searching Authority, PCT/US2008 /000838 , dated Jul. 8 ,
2218/007 (2013.01 ) ; AGIM 25/007 ( 2013.01 ) ; 2008 .
A61M 25/0032 ( 2013.01 ) ; A61M 25/0041
(2013.01 ) ; A61M 25/0102 ( 2013.01 ) ; ACIM * cited by examiner
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US 11,166,703 B2
1 2
DEVICES , SYSTEMS , AND METHODS FOR commonly -used medications and other chemicals that may
ATRIAL APPENDAGE OCCLUSION USING be present in appreciable quantities in food . Accordingly,
LIGHT CURE safer options are desirable .
AF is frequently diagnosed in elderly patients and is
PRIORITY 5 responsible for more than 15 % of all strokes. This percent
age grows to almost 25 % in women and men older than 80
The present application is related to and claims the years of age . Dilation of the left atrium and aa reduction of
priority benefit of: (a ) U.S. Provisional Patent Application blood flow velocity , especially in the left atrial appendage,
Ser. No. 62/ 101,122 to Kassab et al . , filed Jan. 8 , 2015 ; ( b ) is commonly seen with AF . Atrial contraction is responsible
and is aa continuation - in - part of U.S. Nonprovisional appli- 10 for blood ejection out of the left atrium and appendage. The
cation Ser. No. 14 / 177,803 , filed Jan. 8 , 2016 , which is dysfunction of the left atrial contraction is followed by blood
related to and claims the priority benefit of U.S. Provisional stagnation , especially at the level of the atrial appendage . It
Patent Application Ser. No. 62 / 101,135 , filed on Jan. 8 , has been demonstrated by means of echocardiography and
2015 , as well as the applications and patents listed in (c ) - (e ) autopsy studies that more than 90 % of all thrombi in patients
of this paragraph; (c ) and is a continuation - in -part of U.S. 15 with non - rheumatic AF beginning in the left atrium , appear
Nonprovisional application Ser. No. 13 / 937,867 , filed Jul. 9 , in the left atrial appendage. Thrombus formation elevates the
2013 and as of the date the present application is filed, which threat of stroke by three - fold .
is related to , claims the priority benefit of, and is a U.S. The left atrial appendage ( “LAA ” ) is an embryonic rem
continuation application of U.S. Nonprovisional application nant of the left atrium that grows during the third week of
Ser. No. 12 / 863,540 , filed on Jul. 19 , 2010 and issued as U.S. 20 pregnancy. The left atrial cavity develops soon after and is
Pat . No. 8,480,708 on Jul . 9 , 2013 , which is related to , produced from an outgrowth of the pulmonary veins . The
claims the priority benefit of, and is a U.S. $ 371 national diameter of the LAA ostium into the left atrial cavity is about
stage application of, International Application Serial No. 1 to 4 cm and is positioned between the left upper pulmonary
PCT /US2009 /030222, filed Jan. 6 , 2009 , which is related to , vein and the left ventricle . The left axis deviation orifice ,
claims the priority benefit of, and is treated in the United 25 width , and length are typically about 0.7 to 2 cm , 0.9 to 3.4
States of America as a continuation - in -part of, International cm , and 1.3 to 4 cm , respectively. The circumflex branch and
Application Serial No. PCT/US2008/ 000838 , filed Jan. 23 , the left coronary artery runs close to the base of the LAA
2008 , which is related to , and claims the priority benefit of, ostium .
U.S. Provisional Patent Application Ser. No. 60/ 881,831 , The LAA is aa long structure with tubular or hooked shape
filed Jan. 23 , 2007 ; (d) and is a continuation - in -part of U.S. 30 of variable morphology and size . The LAA wall is trabecu
a
Nonprovisional application Ser. No. 14 / 338,031 , filed Jul . lated including muscle bars , known as pectinate muscles.
22 , 2014 and as of the date the present application is filed , The cavities between the pectinate muscles emerge as
which is related to , claims the priority benefit of, and is a “ branches ” (lobes ) , “ twigs ”, or “ fine structures. ” LAA clo
U.S. continuation application of U.S. Nonprovisional patent sure may be an option in patients who cannot receive
application Ser. No. 13 / 537,394 , filed on Jun . 29 , 2012 and 35 anticoagulation treatment as a result of contraindications or
issued as U.S. Pat . No. 8,784,469 on Jul. 22 , 2014 , which is conditions in which the hemorrhage risk is greater than the
related to , and claims the priority benefit of, U.S. Provisional potential medical benefit.
Patent Application Ser. No. 61 / 503,428 , filed Jun . 30 , 2011 ; One of the convention options of treating LAA closure is
and (e ) and is a continuation -in - part of U.S. Nonprovisional surgery . However, it is unsuitable for the same high - risk
application Ser. No. 14/ 177,803 , filed Feb. 11 , 2014 and as 40 patients who are poor candidates for warfarin therapy.
of the date the present application is filed , which is related Accordingly, a safe , accurate and minimally invasive pro
to , claims the priority benefit of, and is a U.S. continuation cedure is needed to occlude the LAA .
application of U.S. Nonprovisional application Ser. No.
12 / 522,674 , filed on Apr. 9 , 2010 and issued as U.S. Pat . No. BRIEF SUMMARY
8,647,367 on Feb. 11 , 2014 , which is related to , claims the 45
priority benefit of, and is a U.S. § 371 national stage Embodiments disclosed herein comprise devices and
application of, International Application Serial No. PCT/ methods of LAA occlusion that do not require surgery and
US08/ 00838 , filed Jan. 23 , 2008 , which is related to , and avoid many of the risks associated with current methods of
claims the priority benefit of, U.S. Provisional Patent Appli LAA occlusion .
cation Ser . No. 60/ 881,831 , filed Jan. 23 , 2007. The contents 50 In at least one embodiment of aa device for occluding an
of each of the aforementioned applications and patents are atrial appendage of a heart, the device comprises a tubular
hereby incorporated by reference in their entirety into this shaft, a balloon , a catheter, an adhesive delivery device , and
disclosure. at least one optical fiber. The tubular shaft of the device is
sized and shaped for insertion into a heart and comprises a
BACKGROUND 55 proximal end , an open distal end, and at least one lumen
extending therebetween . The balloon of the device is
Currently, 2.2 million patients in the United States suffer coupled with the distal end of the shaft and is configured for
atrial fibrillation ( “ AF ” ). About half of these patients are inflation and deflation . In certain embodiments , the balloon
considered to be at a high risk for stroke. The Stroke is additionally configured such that, when the balloon is in
Prevention in Atrial Fibrillation trials (SPAF,SPAF II, SPAF 60 an inflated position and positioned at or adjacent to an atrial
III ) have shown that chronic warfarin therapy reduces the appendage cavity, the balloon is sufficiently sized and
risk of stroke by about 70 % . Nevertheless , problems related shaped to occlude an atrial appendage cavity. The catheter of
with the long term use of anti-coagulation treatments are the device is sized and shaped for slidable insertion into the
well known. It has been shown that up to two - thirds of lumen of the shaft and comprises a proximal end , a distal end
eligible AF patients do not receive warfarin treatment. This 65 having at least one opening, and at least one lumen extend
can be at least partly attributed to the fact that warfarin is ing between the proximal and distal ends thereof. The
difficult to dose as it is known to interact with many adhesive delivery device is coupled with the proximal end of
US 11,166,703 B2
3 4
the catheter and in communication with at least one lumen catheter comprising a proximal end coupled with an adhe
of the catheter. Furthermore, the at least one optical fiber is sive delivery device and a suction source , a distal end having
disposed within one of the at least one lumens of the catheter at least one opening, and at least one lumen extending
and configured to emit light having a range of wavelengths, between the proximal and distal ends thereof, and at least
wherein when light is emitted from the at least one optical 5 one optical fiber disposed within one of the at least one
fiber, the light is communicated through the at least one lumens of the catheter and configured to emit light having a
opening of the distal end of the catheter. Optionally, the range of wavelengths, wherein when light is emitted from
device may further comprise a guidewire to facilitate inser- the at least one optical fiber, the light is communicated
tion of the shaft into a heart and / or the catheter into the atrial through the at least one opening of the distal end of the
appendage cavity. 10 catheter; advancing the distal end of the shaft within an
In at least one embodiment, the device further comprises entrance of the atrial appendage cavity; inflating the balloon
a suction source coupled with the proximal end of the to occlude the entrance of the atrial appendage cavity;
catheter. Here, the suction source is in communication with aspirating the atrial appendage cavity via operation of the
at least one opening of the distal end of the catheter such that suction source; delivering adhesive to the atrial appendage
suction may be communicated therethrough . 15 cavity through the at least one opening in the distal end of
In yet other embodiments, the at least one lumen of the the catheter ; and sealing the atrial appendage cavity by
catheter comprises at least a first lumen , a second lumen , and curing the adhesive therein with light emitted from the at
a third lumen . There , the suction source may be in commu- least one optical fiber . An additional step of collapsing the
nication with the first lumen, the adhesive delivery device atrial appendage cavity ( via the application of suction or
may be in communication with the second lumen , and the at 20 otherwise) may also be included . Furthermore , in at least
least one optical fiber may be positioned within the third one embodiment, the light emitted from the at least one
lumen such that suction , adhesive, and light may each be optical fiber comprises ultraviolet light having a range of
applied through the at least one opening of the distal end of wavelengths between about 300 nm and about 400 nm .
the catheter independently of the others, concurrently there- In another embodiment of a method for occluding an
with , or in any combination thereof. 25 atrial appendage of a heart, the method further comprises the
In an additional embodiment, the balloon of the device steps of: withdrawing the distal end of the catheter from the
comprises a first balloon and aa second balloon . Each of the atrial appendage cavity while continuing to deliver adhesive
first and second balloons is configured for inflation and thereto through the at least one opening in the distal end of
deflation independently of each other. Furthermore, in at the catheter; deflating the balloon ; and withdrawing the shaft
least one embodiment, the first balloon comprises a disc- 30 and balloon from the heart. Additionally or alternatively, the
shaped configuration and the second balloon comprises a balloon of the device may comprise a first balloon and a
conical- shaped configuration. In yet another embodiment of second balloon and each of the first and second balloons may
the device , the first loon , when positioned over an be capable of inflation and deflation independently of each
entrance of the atrial appendage cavity, is capable of infla- other. In such embodiments, the method for occluding an
tion to occlude such entrance, and the second balloon is 35 atrial appendage of aa heart may further comprise the steps
sized and shaped to fit within the entrance of the atrial of: inflating the second balloon within the entrance of the
appendage cavity and , when positioned therein , is capable of atrial appendage cavity to occlude the same; inflating the
inflation to occlude the same . first balloon over the entrance of the atrial appendage cavity
Additionally or alternatively, the device may further com to occlude the same ; deflating the second balloon ; withdraw
prise a patch removably coupled with the distal end of the 40 ing the distal end of the catheter from the atrial appendage
shaft . In at least one embodiment, the patch is disposed cavity while continuing to deliver adhesive thereto through
between the first and second balloons . The patch may be the at least one opening in the distal end of the catheter ;
configured to occlude an ostium of an atrial appendage when deflating the first balloon ; and withdrawing the shaft and
positioned thereover . Furthermore, in at least one embodi- first and second balloons from the heart.
ment, the patch is removably coupled with the distal end of 45 Furthermore, in at least one additional embodiment of the
the tube via a valve . There , the valve may be biased to method described herein , the device introduced (at least
self - close when the patch is uncoupled from the shaft. The partially ) into an atrial appendage cavity of a heart may
patch may be comprised of a material selected from the additionally comprise a patch removably coupled with the
group consisting of polytetrafluoroethylene, polyurethane, distal end of the shaft, the patch configured to occlude an
silicone rubber, Dacron , and biologic material. In at least one 50 ostium of the atrial appendage cavity. In such embodiments,
embodiment, the material of the patch comprises a resorb- the method may additionally comprise the steps of securing
able material. the patch over the ostium of the atrial appendage cavity and
As previously described , the at least one optical fiber is decoupling the patch from the shaft. In at least one embodi
configured to emit light. In at least one embodiment, the ment, the patch may be removably coupled with the distal
light comprises ultraviolet light having a range of wave- 55 end of the tube via a valve . There, the valve may be biased
lengths between about 300 nm and about 400 nm . to self -close upon decoupling the patch from the shaft .
Methods for occluding an atrial appendage of a heart are Alternative embodiments of a device for occluding an
also disclosed . In at least one embodiment of aa method for atrial appendage of a heart are additionally provided . For
occluding an atrial appendage of a heart, the method com- example , in at least one embodiment, such a device may
prises the steps of: introducing at least a portion of a device 60 comprise a shaft, a first balloon and a second balloon, a
into an atrial appendage cavity of a heart, the device patch , a catheter, an adhesive delivery device , a suction
comprising a tubular shaft sized and shaped for insertion source , and at least one optical fiber. In such embodiments,
into a heart, the shaft comprising a proximal end , an open the shaft is sized and shaped for insertion into a heart and
distal end, and at least one lumen extending therebetween , a comprises a proximal end , an open distal end, and at least
balloon coupled to the distal end of the shaft, the balloon 65 one lumen extending therebetween . The first and second
configured for inflation and deflation, a catheter sized and balloons of the device are coupled with the distal end of the
shaped for slidable insertion into the lumen of the shaft, the shaft, and each of such balloons is configured for inflation
US 11,166,703 B2
5 6
and deflation independently of the other. Furthermore , when FIG . 8E shows a side view of at least one embodiment of
each of the first and second balloons is inflated , such an occlusion assembly as applied to treat a left atrial
balloons are configured to occlude at least a portion of an appendage;
atrial appendage cavity when positioned within or adjacent FIG . 8F shows a side view of a left atrial appendage that
thereto . 5 has been occluded using the occlusion assembly of FIGS .
The patch of the device is removably coupled with the 8A-E ;
distal end of the shaft and disposed between the first and FIGS . 9A and 9B show two side views of at least one
second balloons . Furthermore, in at least one embodiment, embodiment of an occlusion assembly as applied to treat a
the patch is configured to occlude an ostium of the atrial left atrial appendage;
appendage when positioned thereover. 10 FIGS . 10A , 10B , and 10C show side views of the occlu
In this embodiment, the catheter of the device is sized and sion assembly of FIGS . 9A - 9B in operation ;
shaped for slidable insertion into a lumen of the shaft and FIGS . 11A , 11B , and 11C show various embodiments of
comprises a proximal end, a distal end having at least one a pigtail catheter that may be used to treat a left atrial
opening and at least one lumen extending between the appendage;
proximal and distal ends thereof. Furthermore, the adhesive
15 FIGS . 12 , 13 , 14A , and 14B show a side view of the
2
delivery device is coupled with the proximal end of the pigtail catheter of FIGS . 11A - 11C as applied to treat a left
atrial appendage.
catheter such that it is in communication with at least one FIG . 15 shows a diagram of the components of an
lumen of the catheter. Likewise, the suction source is exemplary system for occluding an atrial appendage of the
coupled with the proximal end of the catheter and in 20 present disclosure;
communication with at least one opening of the distal end of FIG . 16 shows an exemplary embodiment of a first device
the catheter. Still further, in at least one embodiment of the of an exemplary system for occluding an atrial appendage of
device , the at least one optical fiber is disposed within at the present disclosure;
least one of the lumens of the catheter and configured to emit FIG . 17 shows aa view of a heart with an exemplary system
light having a range of wavelengths such that, when light is 25 for occluding an atrial appendage of the present disclosure
emitted from the at least one optical fiber, the light is positioned therein ;
communicated through the at least one opening of the distal FIG . 18A shows a view of a portion of aa heart with a
end of the catheter. balloon of a first device positioned within an atrial append
age cavity ;
BRIEF DESCRIPTION OF THE DRAWINGS 30 FIG . 18B shows a view of a portion of aa heart with an
inflated balloon of a first device positioned within an atrial
FIG . 1A shows a side view of at least one embodiment of appendage cavity and a loop of a second device positioned
an occlusion assembly ; around an atrial appendage;
FIG . 1B shows a cross - sectional view of at least one FIG . 18C shows a view of a portion of a heart with a loop
embodiment of the occlusion assembly taken along line A - A 35 ofFIG
a second
a
deviceanother
. 19 shows securedviewaround an atrial
of aa heart withappendage ;
an exemplary
of FIG . 1A ;
FIGS . 2A , 2B , 2C , 2D , and 2E show side views of the system for occluding an atrial appendage of the present
.
occlusion assembly of FIGS . 1A and 1B as applied to treat disclosure positioned therein ;

a left atrial appendage; FIG . 20A shows a view of a portion of a heart with a
FIG . 3A shows a side view of at least one embodiment of 40 balloon of a first device positioned at the opening of an atrial
appendage cavity ;
an occlusion assembly ; FIG . 20B showsa a view of a portion of aa heart with an
FIG . 3B shows a cross - sectional view of at least one inflated balloon of a first device positioned at the opening of
embodiment of the occlusion assembly taken along line A -A an atrial appendage cavity and a loop of a second device
of FIG . 3A ; 45 positioned around an atrial appendage;
FIG . 4A shows a side view of at least one embodiment of FIG . 20C shows aa view of a portion of a heart with a loop
an occlusion assembly comprising a double balloon con- of a second device secured around an atrial appendage;
figuration and a patch ; FIGS . 21A and 21B show exemplary embodiments of
FIGS . 4B and 4C show perspective views of the patch of systems for occluding an atrial appendage of the present
the occlusion assembly of FIG . 4A ; 50 disclosure; and
FIGS . 5A - 5D show side views of an occlusion assembly FIG . 21C shows an exemplary embodiment of a second
as applied to treat a left atrial appendage; device of an exemplary system for occluding an atrial
FIG . 5E shows the left atrial appendage of FIGS . 5A - 5D appendage of the present disclosure.
following treatment with the occlusion assembly ;
FIGS . 6A and 6B show side views of the occlusion 55 DETAILED DESCRIPTION
assembly of FIGS . 3A and 3B as applied to treat a left atrial
appendage ; Reference will now be made to the embodiments illus
FIG . 7A shows a side view of at least one embodiment of trated in the drawings and specific language will be used to
the occlusion assembly of FIGS . 4A - 4C ; describe the same . It will nevertheless be understood that no
FIG . 7B shows a side view of left atrial appendage 60 limitation of scope is intended by the description of these
following treatment with the occlusion assembly of FIG . embodiments. On the contrary, this disclosure is intended to
7A ; cover alternatives, modifications, and equivalents as may be
2
FIG . SA shows a side view of at least one embodiment of included within the spirit and scope of this application as
an occlusion assembly ; defined by the appended claims . As previously noted, while
FIGS . 8B , 8C , and 8D show side views of the needle wires 65 this technology may be illustrated and described in one or
of the occlusion assembly of FIG . 8A applied to treat a left more preferred embodiments, the devices, systems and
atrial appendage; methods hereof may comprise many different configura
US 11,166,703 B2
7 8
tions , forms, materials , and accessories . For example, while LAA cavity, including, without limitation , a hemisphere
the novel systems , methods and techniques of the present shape and a wine - bottle cork shape.
application may be described in the context of occluding The occlusion assembly 10 further comprises a guidewire
and / or treating a left atrial appendage ( “ LAA ” ) in a heart, 18. The guidewire 18 is configured to be inserted through the
the inventive concepts underlying the devices, systems , and 5 interior 24 of the shaft 12 and may be any standard
methods hereof may also be applied to other medical appli- guidewire known in the art. In one embodiment, the
cations. guidewire 18 functions to facilitate navigation of the shaft
In the following description, numerous specific details are 12 and catheter 16 into the LAA . Use of the guidewire 18
set forth in order to provide a thorough understanding of the enables more effective navigation of the occlusion assembly
present disclosure . Particular examples may be implemented 10 10 and prevents damage to the atrial or appendage walls .
without some or all of these specific details. In other In one approach, the procedure can be performed under
instances, well known delivery, patient-care, and other local anesthesia and conscious sedation . The shaft 12 and the
medical procedures and operations have not been described balloon 14 coupled therewith are inserted through the femo
in detail so as to not unnecessarily obscure the present ral vein and advanced to the right atrium of the heart.
disclosure . 15 Thereafter, a trans - septal puncture is made at the level of the
Various techniques and mechanisms of the present dis- fossa ovalis area to access the left atrium . After the shaft 12
closure will sometimes describe a connection between two and the balloon 14 are positioned within the left atrium , the
components. Words such as attached, affixed , coupled , con- guidewire 18 is inserted into the LAA , visualized by fluo
nected , and similar terms with their inflectional morphemes roscopy or transesophageal echocardiography, and the shaft
are used interchangeably, unless the difference is noted or 20 12 is threaded over the guidewire 18 such that the balloon 14
made otherwise clear from the context. These words and is positioned adjacent to the ostium of the LAA . When the
expressions do not necessarily signify direct connections, balloon 14 is properly positioned , as shown in FIG . 1A , the
but include connections through mediate components and balloon 14 is inflated to occlude the LAA orifice .
devices. It should be noted that a connection between two After the shaft 12 and the balloon 14 are properly posi
components does not necessarily mean a direct, unimpeded 25 tioned with respect to the LAA , the catheter 16 may be
connection , as a variety of other components may reside introduced . The catheter 16 of the occlusion assembly 10
between the two components of note . Consequently, a comprises an elongated , flexible tube having an exterior
connection does not necessarily mean a direct , unimpeded waft, a proximal end 30 , a distal end 32 , a hollow interior 34 ,
connection unless otherwise noted . and at least one opening 36 disposed through the exterior
Furthermore, wherever feasible and convenient, like ref- 30 wall . The proximal end 30 of the catheter 16 is in commu
erence numerals are used in the figures and the description nication with the interior 34 , and the interior 34 extends
to refer to the same or like parts or steps . The drawings are throughout the length of the catheter 16. Accordingly, the
in a simplified form and not to precise scale . It is understood interior 34 of the catheter 16 provides a channel through
that the disclosure is presented in this manner merely for which the distal end 32 may be accessed .
explanatory purposes and the principles and embodiments 35 The catheter 16 is configured to be slidably positioned
described herein may be applied to devices and / or system within the interior 24 of the shaft 12. For example, the distal
components that have dimensions /configurations other than end 32 of the catheter 16 can be inserted into the proximal
as specifically described herein . Indeed , it is expressly end 20 of the shaft 12 , advanced through the interior 24 of
contemplated that the size and shapes of the devices and the shaft 12 , and extended into the LAA cavity. In one
system components of the present disclosure may be tailored 40 embodiment, the catheter 16 comprises a length that is
in furtherance of the desired application thereof and / or in greater than the length of the shaft 12 such that the distal end
accordance with a patient's physiology 32 of the catheter 16 can conveniently be extended through
FIG . 1A shows a side view of one embodiment of an the distal end 22 of the shaft and into the LAA cavity.
occlusion assembly 10 for closing a left atrial appendage. Further, in at least one embodiment, the catheter 16 com
Specifically, the assembly 10 is configured for placement 45 prises a three - lumen pigtail catheter, such that the distal end
within the LAA and is delivered non -surgically through the 32 is tightly curled . This tightly curled configuration func
use of catheterization and percutaneous transluminal access . tions to prevent trauma in the event the proximal end 32
The occlusion assembly 10 comprises a shaft 12 , a comes into contact with a vessel or organ wall as the catheter
balloon 14 , a catheter 16 , and a guidewire 18. The shaft 12 16 is advanced through the body of a patient.
.
comprises an elongated catheter shaft having a proximal end 50 The distal end 32 of the catheter 16 comprises at least one
20 , a distal end 22 , and an interior 24. Both the proximal end opening 36 disposed therein . Each of openings 36 located on
20 and the distal end 22 of the shaft 12 are open and in the distal end 32 is in communication with the interior 34 of
communication with the interior 24. The interior 24 of the the catheter 16 and comprises a configuration such that a
shaft 12 extends throughout the length of the shaft 12 and force, light, or substance can be transmitted therethrough .
provides a channel through which the distal end 22 of the 55 For example, in one embodiment, the at least one opening 36
shaft 12 may be accessed when positioned within a body. comprises a suction port configured to aspirate an area
The balloon 14 is coupled with the distal end 22 of the adjacent to the catheter 16 when the at least one opening 36
shaft 12 and can comprise any balloon catheter tip known in is coupled with a vacuum source . In an alternative embodi
the art. The balloon 14 may comprise a tube or other ment, the at least one opening 36 comprises a single opening
inflation means (not shown) coupled therewith to facilitate 60 at the distal end 32 of the catheter 16 , configured such that
the inflation and deflation of the balloon 14 when positioned the guidewire 18 or other device can be positioned there
within the body. The balloon 14 can be configured in a range through. In yet another embodiment, the at least one opening
of sizes to accommodate the anatomy of the left atrial 36 is configured to deliver a substance to the surrounding
appendage. In one embodiment, the balloon 14 comprises a tissue , such as an adhesive or medicament. Still further, the
flattened - disk configuration, however it will be understood 65 at least one opening 36 may comprise a plurality of openings
that the balloon 14 can comprise various shapes and forms 36 positioned around the distal end 32 of the catheter 16
that will assist in the temporary closing and sealing of the ( see , for example, FIG . 2A) and configured such that light
US 11,166,703 B2
9 10
can be radiated therethrough to the surrounding tissue . The functionality of the occlusion assembly 10 , and it will be
number of openings 36 located on the distal end 32 of the understood that any number of openings 36 may be
catheter 16 may depend on the desired functionality of the employed . The operation of the occlusion assembly 10 will
occlusion assembly 10 , and it will be understood that any
2 now be described with respect to the at least one embodi
number of openings 36 may be employed. 5 ment of the catheter 16 shown in FIG . 2A . While this
As previously described, the interior 34 of the catheter 16 embodiment is described herein , it is understood that any of
extends from the proximal end 30 of the catheter 16 to the the embodiments of the catheters 16 described herein may
distal end 32 of the catheter 16. Further, the interior 34 is in be used to occlude a LAA .
communication with the at least one opening 36. Accord- In operation , the guidewire 18 is threaded through the
ingly, the interior 34 of the catheter 16 can function as a 10 previously deployed shaft 12 and inserted into the cavity of
conduit through which a force, light, device, and / or sub- the LAA , visualized by fluoroscopy or transesophageal
stance may be delivered to the at least one opening 36. For echocardiography. After the guidewire 18 has accessed the
example, when a vacuum source , such as a syringe or other cavity of the LAA , the distal end 32 of the catheter 16 is
vacuum source , is coupled with the proximal end 30 of the advanced through the distal end 22 of the shaft 12 and into
catheter 16 , the suctional force produced thereby can be 15 the cavity of the LAA as shown in FIG . 2A . While main
communicated throughout the interior 34 of the catheter 16 taining the inflation of the balloon 14 occluding the LAA
and through the at least one opening 36 in communication ostium , suction is initiated through the catheter 16. Specifi
therewith . In one embodiment, a syringe or other vacuum cally, a vacuum source is coupled with the first lumen 41
source ( not shown) may be coupled with the proximal end such that a vacuum is created therein . In this manner, the
30 of the catheter 16 in order to provide appropriate suction 20 plurality of openings 36 function to aspirate the cavity of the
throughout the interior 34 of the catheter 16. It will be LAA . This suctional force is maintained until a small
understood that any type of vacuum source may be used to amount of blood is removed from the LAA cavity and the
supply suction throughout the interior 34 , such as a con- LAA wall collapses as shown in FIG . 2B . After the LAA
trolled vacuum system providing specific suction pressures. wall is completely collapsed , the suction is ceased . As the
In another embodiment, an adhesive delivery device ( not 25 balloon 14 is occluding the LAA ostium and the LAA cavity
shown ) is coupled with the proximal end 30 of the catheter is sealed , the collapse is maintained even in the absence of
16. The adhesive delivery device may comprise any means aspiration.
for advancing an adhesive through the interior 34 of the At this point, the catheter 16 is used to inject an adhesive
catheter and through the at least one opening 36. For 47 into the collapsed LAA cavity. In one embodiment the
example, in one embodiment, the adhesive delivery device 30 adhesive 47 comprises a biologic glue , however, the adhe
may be aa clinician's hand when he or she applies force to a sive 47 can comprise any adhesive known in the medical
container of adhesive such that the adhesive is advanced arts . Accordingly, the occlusion assembly 10 may further
through the interior 34 of the catheter 16. In an alternative comprise a delivery apparatus ( not shown ) for providing the
embodiment, the adhesive delivery device may comprise a adhesive 47 to the catheter 16. In one embodiment, the
specifically designed mechanism for advancing the adhe- 35 delivery apparatus is coupled with the third lumen 46 such
sive . that the adhesive 47 is advanced therethrough and applied to
Referring now to FIG . 1B , in one embodiment, the the cavity of the LAA through the at least one of opening 36
interior 34 of the catheter 16 comprises multiple lumens. In in communication therewith . As shown in FIG . 2C , the
the embodiment shown in FIG . 1B , the occlusion assembly application of the adhesive 47 within the collapsed LAA
10 comprises a triple - lumen pigtail catheter, comprising a 40 functions to seal the LAA . Further, as the catheter 16
first lumen 42 , a second lumen 44 , and a third lumen 46. In delivers the adhesive 47 into the LAA cavity, the catheter 16
this embodiment, the first lumen 42 is disposed around the is slowly withdrawn through the interior 24 of the shaft 12
circumference of the catheter 16 and the second and third (FIG . 2D) .
lumens 44 , 46 are disposed centrally within the interior 34 . After the adhesive 47 has completed sealing , the balloon
The second and third lumens 44 , 46 are wholly surrounded 45 14 is deflated . Thereafter, the left atrium of the heart can be
by the first lumen 42. While this specific configuration is injected with dye in order to show angiographically the LAA
shown with respect to FIG . 1B , it will be appreciated that the occlusion . Once the success of the procedure has been
interior 34 may comprise any number of lumens and the confirmed, the shaft 12 and the balloon 14 are withdrawn
lumens can be arranged in any configuration. from the body, across the interatrial septum and back
The multiple lumens enable the catheter 16 to perform 50 through the femoral vein , thereby leaving the cavity of LAA
multiple functions without withdrawing the catheter 16 from sealed as shown in FIG . 2E .
the body or employing more than one device . For example, Now referring to FIGS . 3A and 3B , at least one additional
a plurality of openings 36 configured to aspirate a tissue may embodiment of an occlusion assembly 50 for closing a LAA
be in communication with the first lumen 42 , a single is shown . The occlusion assembly 50 comprises the shaft 12 ,
opening 36 configured to receive the guidewire 18 there- 55 the balloon 14 , the catheter 16 , and the guidewire 18 , all of
through may be in communication with the second lumen which are configured identically to the shaft 12 , balloon 14 ,
44 , and a plurality of openings 36 configured to deliver light catheter 16 , and guidewire 18 of occlusion assembly 10 .
and / or a substance to a tissue may be in communication with Configuration of these like components will not be described
the third lumen 46. In this manner, the catheter 16 is capable again in detail with respect to the occlusion assembly 50 and
of various functionalities including, without limitation , 60 like reference numerals between the various embodiments
delivering suction to the cavity of the LAA , advancing the will refer to like components. However, in addition to the
guidewire 18 to ensure accurate navigation throughout the features like those of the occlusion assembly 10 previously
body, and applying an adhesive to the LAA . It will be described, the occlusion assembly 50 further comprises at
recognized that the catheter 16 may further comprise any least one optical fiber 60 for delivering a light -based treat
combination of the aforementioned embodiments on a single 65 ment through the catheter 16 ( see FIG . 3B ) . Accordingly, in
device . In addition, the number of openings 36 located on this exemplary embodiment, occlusion assembly 50 is con
the distal end 32 of the catheter 16 depends on the desired figured to perform multiple functions — including applying a
US 11,166,703 B2
11 12
force (e.g. , suction) , injecting a substance (e.g. , an adhe- of the LAA and / or a particular patient, or to achieve a
sive ) , and delivering light having a desired wavelength desired effect in delivering treatment to the LAA . For
range__without withdrawing the catheter 16 and /or occlu- example, in the at least one exemplary embodiment shown
sion assembly 50 from the body or employing more than one in FIG . 3A , the first balloon 14a comprises a disc - shaped
device . 5 balloon and the second balloon 14b comprises a conical
The optical fiber 60 comprises a proximal end ( not shaped balloon .
shown ), a distal end 62 (more clearly seen in FIGS . 5A - 5D , In the embodiment of FIG . 3A , the conical- shaped second
and a light source for producing light having a desired balloon 14b is positioned distally on the shaft 12 relative to
wavelength range ( not shown) . Furthermore, the optical the first balloon 14a and configured such that when it is
fiber 60 may additionally comprise a control mechanism 10 positioned within at least a portion of the LAA and inflated ,
( not shown) that permits the measured application of the the conical - shaped balloon can accommodate the anatomy
desired light wavelengths. Each optical fiber 60 may be any of the LAA and securely occlude the same . Additionally, the
standard optical fiber or fiber light known in the art and is first balloon 14a comprises a flattened -disc configuration
configured to transmit the light produced by the light source designed for placement over the entrance of the LAA .
through its distal end 62 in aa therapeutically effective pattern 15 Accordingly , in application , the disc -shaped first balloon
or as otherwise may be desired . In at least on exemplary 14a can also be used to assist with the temporary closing of
embodiment, the optical fiber 60 comprises an ultraviolet the LAA cavity even though , in this embodiment, it is
(UV ) fiber light configured to radiate UV light (having configured for placement over the entrance of the LAA and
wavelengths ranging between about 300 nm and about 400 not within the LAA cavity itself. While specific balloon
nm ) from the distal end 62 thereof. 20 configurations have been provided by way of explanatory
Similar to the guidewire 18 , the distal end 62 of the optical example, it will be understood that the balloon 14 ( including
fiber 60 is configured for insertion through the interior 34 of balloons 14a and 14b ) may comprise various shapes and
the catheter 16. Where the interior 34 of the catheter 16 forms that will assist in the temporary closing and sealing of
comprises multiple lumens, the distal end 62 of the optical the LAA cavity.
fiber 60 may be slidably inserted or otherwise positioned 25 FIGS . 4A - 4C illustrate at least one optional feature of the
through any of the available lumens 42 , 44 , 46 , etc. as occlusion assembly 50. Here, in addition to the first and
desired pursuant to the specific application and / or patient second balloons 14a , 14b , an occlusion patch 70 is remov
physiology. For example, as shown in FIG . 3B , the distal end ably coupled with the distal end 22 of the shaft 12. In
62 of the optical fiber 60 may be disposed within the distal particular, the patch 70 is disposed in between the first and
end 32 of the catheter 16 via the third lumen 46. Further- 30 second balloons 14a , 14b as shown in FIG . 4A such that, in
more, where more than one optical fibers 60 are used , the operation , the patch 70 may be positioned over the exterior
fibers 60 may be positioned within one or more of the of the LAA ostium when the second balloon 14b is posi
available lumens 46 , etc. as desired . tioned within the ostium and / or cavity of the LAA .
Because the interior 34 of the catheter 16 is in commu- The occlusion patch 70 , in various embodiments, may be
nication with the at least one opening 36 , when the at least 35 comprised of a variety of conventional and biocompatible
one optical fiber 60 is inserted into the interior 34 of the materials capable of preventing the passage of blood ,
catheter 16 , any light emitted therefrom into the interior 34 emboli, and / or any substance ( e.g. , adhesive ) residing within
of the catheter 16 will also be communicated through the at the LAA from escaping into the blood pool . Examples of
least one opening 36. Accordingly , in addition to being such materials include , without limitation , various polytet
configured to deliver aa force (e.g. , suction) , a device (e.g. , a 40 rafluoroethylenes (PTFEs), polyurethanes, silicone rubbers,
guidewire 18 ) , and / or a substance ( e.g. , adhesive ) to sur- Dacron , and / or various biologic materials such as bovine
rounding tissue , the catheter 16 can also be configured to pericardium and the like . In at least one embodiment, the
emit light having a desired wavelength range through the patch 70 comprises a resorbable material such that, after a
opening (s ) 36. Such function can be exceedingly useful, prescribed amount of time has passed , the patch 70 resorbs
especially where a light - cured adhesive 47 is being used to 45 or degrades. Additionally or alternatively, the patch 70 may
seal the LAA cavity. have an adhesive ( biological or otherwise) applied to at least
Other modifications of the occlusion assembly 50 may one side thereof in order to facilitate the secure placement
also be employed. For example, in addition to comprising at against the ostium of an LAA .
least one optical fiber 60 , in at least one exemplary embodi- The patch 70 comprises a flattened , disc - shaped configu
ment, the balloon 14 of the occlusion assembly 50 may 50 ration and is sized and shaped to occlude the entrance of a
comprise a double balloon configuration as shown in FIG . LAA . In at least one embodiment, the patch 70 comprises a
3A . In this at least one embodiment, the balloon 14 com- diameter that is slightly larger than the ostium of the targeted
prises a first balloon 14a and a second balloon 14b , each of LAA such that, when it is applied thereover, the patch 70
which may comprise any balloon catheter tip known in the effectively occludes the same . Notwithstanding the forego
art and aa tube or other inflation means (not shown) coupled 55 ing , patches 70 can be manufactured in a variety of shapes
therewith to facilitate the inflation and deflation of the and sizes and the specific configuration and / or dimensions of
balloons 14a , 14b when positioned within the body. Notably, a patch 70 can even be tailored to a particular patient's
first and second balloons 14a , 14b are configured such that physiology and / or for a specific application.
they can be inflated and deflated independently of one The patch 70 has a valve 72 , which may be at or near the
another. Accordingly, the first and second balloons 14a , 14b 60 relative center of the patch 70. The valve 72 is configured to
may be coupled with independent inflation means ( not receive the shaft 12 of the occlusion assembly 50 and, as
shown) or, if coupled with the same inflation means , the described in further detail below , allows the shaft 12 to be
inflation means is configured such that each balloon 14a , removed at the end of the method/ protocol. In at least one
14b can be independently inflated and deflated ( either embodiment, the valve 72 is self- closing so that after the
through the use of valves or otherwise ). 65 shaft 12 has been removed, passage through the valve 72 is
The first and second balloons 14a , 14b may be configured fully closed and the patch 70 is fully occlusive to the passage
in aa range of sizes and shapes to accommodate the anatomy of blood, emboli, and /or any substance within the interior of
US 11,166,703 B2
13 14
the LAA . Suitable self -closing valves 72, by way of configuration embodiment, there are a few aspects that
example , include but are not limited to flap valves , duck- differ. Descriptions of the same will now be provided ,
billed valves , slit valves , and the like . however, it will be appreciated that those delivery and / or
Operation of the various embodiments of the occlusion operative steps that are identical to the embodiments previ
assembly 50 will now be described . Primarily, the guidewire 5 ously described will not be set forth in detail so as not to
18 is threaded through the previously deployed shaft 12 and unnecessarily obscure the present disclosure .
inserted into the cavity of the LAA , visualized by fluoros- Where the occlusion assembly 50 comprises a double
copy or transesophageal echocardiography. As with the balloon configuration , the guidewire 18 is initially threaded
delivery of occlusion device 10 , use of the guidewire 18 through the previously deployed shaft 12 and inserted into
2
enables more effective navigation of the occlusion assembly 10 the cavity of the LAA as previously described . Thereafter,
50 to the desired location and prevents damage to the atrial the distal end 32 of the catheter 16 is advanced through the
or LAA walls . distal end 22 of the shaft 12 and into the cavity of the LAA .
After the guidewire 18 has accessed the cavity of the When the distal end 22 of the shaft 12 is positioned at least
LAA , the distal end 32 of the catheter 16 is advanced partially within the cavity of the LAA and the catheter 16 is
through the distal end 22 of the shaft 12 and into the cavity 15 advanced therethrough as previously described, the balloon
of the LAA as shown in FIG . 5A . While maintaining the 14 is positioned at or near the ostium (or entrance ) of the
inflation of the balloon 14 occluding the LAA ostium , LAA . More specifically and as illustrated in FIG . 6A , the
suction is initiated through the catheter 16. Specifically, a conical -shaped second balloon 14b is seated within the
suction source is coupled with the first lumen 41 such that ostium and / or cavity of the LAA , and the first balloon 14a
a vacuum is created therein . In this manner, the opening (s) 20 is positioned over the ostium of the LAA . Accordingly, in
36 in communication with the first lumen 41 of the catheter this exemplary embodiment, the double balloon configura
16 function to aspirate the cavity of the LAA . This suctional tion provides two barriers to temporarily seal off the LAA
force is maintained until a small amount of blood is removed cavity from the interior of the heart and the bloodstream
from the LAA cavity and the LAA wall collapses as shown during treatment of the LAA .
in FIG . 5B . After the LAA wall is completely collapsed, the 25 Due to its configuration, the conical-shaped second bal
suction is ceased . As the balloon 14 is occluding the LAA loon 14b is extremely effective at temporarily sealing the
ostium and the LAA cavity is sealed , the collapse is main- LAA cavity such that the LAA walls remain completely
tained even in the absence of aspiration . collapsed following aspiration , and any adhesive 47 deliv
At this point, the catheter 16 is used to inject an adhesive ered therein is prevented from leaking out . However,
47 that is cured by the presence of ultraviolet light or another 30 because the second balloon 14b takes up some space within
radiation cure into the collapsed LAA cavity ( see FIG . 5C) . the LAA cavity itself, subsequent deflation of the second
Accordingly , the occlusion assembly 50 further comprises a balloon 14b results in aa void within the LAA cavity that is
delivery apparatus ( not shown) for providing the adhesive not filled with adhesive. To prevent the presence of this void ,
47 to the catheter 16 such that the adhesive 47 is ultimately the first and second balloons 14a , 14b can be deflated
delivered to the cavity of the LAA through the at least one 35 independently of one another during treatment of the LAA .
opening 36 of the catheter 16. As the catheter 16 delivers the In particular, after the LAA walls are collapsed, the
adhesive 47 into the LAA cavity, the catheter 16 is slowly suction is ceased , and the adhesive 47 is delivered into the
withdrawn through the interior 24 of the shaft ( see the collapsed LAA cavity as previously described. Following
directional arrow of FIG . 5D ) . these steps , or concurrent therewith as desired , the optical
Concurrent with or after the delivery of the adhesive 47 , 40 fiber ( s ) 60 of the occlusion assembly 50 is / are activated , thus
the at least one optical fiber 60 of occlusion assembly 50 is emitting light wavelengths into the LAA cavity and curing
activated . Because the adhesive 47 in this embodiment is the adhesive 47 present therein ( e.g. , in at least one embodi
cured in the presence of ultraviolet light or other radiation ment, the light wavelengths comprise UV light wave
cure , exposure of the adhesive 47 to the light wavelengths lengths ). As the LAA cavity fills with adhesive 47 , the
( e.g. , UV light) emitted from the optical fiber 60 through the 45 second balloon 14b may be deflated and the catheter 16
opening ( s) 36 of the catheter 16 cures the adhesive 47 slowly withdrawn through the interior 24 of the shaft 12 .
present within the LAA cavity as the catheter 16 is slowly While the distal end 32 of the catheter 16 retracts, adhesive
retracted therefrom . In this manner, the occlusion assembly 47 is delivered into the LAA cavity , thereby filling any void
50 can not only deliver adhesive 47 into the LAA cavity, but left by the deflation of the second balloon 14b ( see FIG . 6B )
can also facilitate the quick solidification thereof without 50 Likewise , as the catheter 16 retracts , light wavelengths may
withdrawing the occlusion assembly 50- or even a compo also be emitted therefrom via the optical fiber (s) 60 to cure
nent thereof — from the patient's body. the adhesive 47 within the cavity. Note that, during this
Ultimately, the cured adhesive 47 substantially fills the process, the first balloon 14a continues to occlude the ostium
collapsed LAA cavity and functions to quickly seal the of the LAA such that it remains sealed off from the right
LAA . After the adhesive 47 has completed sealing , the 55 atrium despite the deflation of the second balloon 14b .
balloon 14 is deflated . Thereafter, the left atrium of the heart After the LAA is substantially occluded by adhesive 47 ,
can be injected with dye in order to show angiographically the adhesive 47 is cured , and sealing is complete , the first
the LAA occlusion . Once the success of the procedure has balloon 14a is also deflated . Following confirmation that the
been confirmed , the shaft 12 and the balloon 14 are with- procedure was successful, the occlusion assembly 50 may
drawn from the body, across the interatrial septum and back 60 then be withdrawn from the body as previously described .
through the femoral vein , thereby leaving the cavity of LAA In addition to a double balloon configuration, certain
sealed as shown in FIG . 5E . embodiments of the occlusion assembly 50 may also com
As previously described , certain embodiments of the prise a patch 70. Indeed, in this embodiment, the patch 70
occlusion assembly 50 comprise a balloon 14 having a provides an additional element of occlusion that remains in
double balloon configuration. While the delivery and opera- 65 place within the patient after the other components of the
tion of these embodiments of the occlusion assembly 50 are occlusion assembly 50 are withdrawn . While the delivery
very similar to the previously described single balloon and operation of this embodiment of the occlusion assembly
US 11,166,703 B2
15 16
50 is very similar to those embodiments previously may be composed of any material known in the medical arts
described, there are a few aspects relating to the patch 70 suitable for application within the heart. The hollow interior
that differ over previously described steps . Descriptions of 134 of the catheter 116 extends the length of the catheter
the unique steps associated with the patch 70 will now be 116 , and in one embodiment, the interior 134 of the catheter
2
provided, however, as with the previously described double 5 116 comprises at least two independent lumens .
balloon configuration, it will be appreciated that the delivery The needle wires 121 are coupled with the distal end 132
and / or operative steps that are identical to the embodiments of the catheter 116 and extend therefrom . The needle wires
previously described will not be set forth in detail to prevent 121 are hollow so that a magnetic glue - like substance or
duplicative disclosure . other suitable substance ( not shown) can pass therethrough .
Referring back to the configuration of the occlusion 10 In one embodiment, each of the needle wires 121 comprise
assembly 50 comprising a patch 70 , the patch 70 is mounted a lumen extending the length of the needle wire 121 and a
at a location distal to the first balloon 14a . Accordingly, distal needle aperture 123 in communication with the lumen .
when the distal end 22 of the occlusion assembly 50 is The needle wires 121 may be composed of any suitable
delivered to a LAA , the patch 70 is sandwiched in between material commonly used in the medical arts that serves the
the ostium (or entrance) of the LAA and the first balloon 15 functions noted herein including, without limitation , a
14a . Because the patch 70 is slightly larger than the LAA metallic compound. In one embodiment, the needle wires
ostium , the patch 70 covers the entire ostium of the LAA and 121 are comprised of a very fine, hollow wire .
facilitates occlusion of the same . In this manner, the patch 70 The catheter needle 118 can be slidably positioned within
works with the first and second balloons 14a , 14b to occlude the interior 24 of the shaft 12. When the needle wires 121 of
the LAA cavity and, at least initially, help preserve its 20 the catheter needle 118 are encased within the interior 24 of
collapse . the shaft 12 , the needle wires 121 are necessarily in aa closed ,
Following delivery of adhesive 47 within the collapsed joined form . In this manner, a clinician can effectively
LAA, the catheter 16 is slowly withdrawn through the manipulate the catheter needle 118 containing the needle
interior 24 of the shaft 12 ( see FIG . 4A ) , thus filling the wires 121 in and around a patient's body without the needle
entire LAA cavity with adhesive 47 ( similar to the embodi- 25 wires 121 protruding and contacting surrounding tissue .
ments shown in FIGS . 6A and 6B ) . Concurrently, the optical However, once the catheter needle 118 is properly posi
fiber ( s ) 60 is / are activated to emit the desired light wave- tioned ( e.g. , within the atrial appendage ), a clinician may
lengths and thereby cure the adhesive 47 present within the advance the catheter needle 118 through the distal end 22 of
LAA cavity. As shown in FIG . 7A , the second balloon 14b the shaft 12 , thereby exposing the needle wires 121 and
is deflated prior to withdrawal such that adhesive 47 is 30 allowing them to expand as shown in FIG . 8B .
allowed to substantially fill and solidify in the area previ- The lumen of each of the needle wires 121 is in commu
ously occupied thereby. After the cured adhesive 47 fills the nication with the hollow interior 134 of the catheter 116. In
LAA cavity and blocks the LAAostium , the first balloon 14a the embodiment where the catheter 116 comprises at least
is deflated and the shaft 12 and balloons 14a , 14b are two independent lumens , the lumens of each of the needle
withdrawn from the body. Specifically, the shaft 12 and the 35 wires 121 may be in communication with one of the lumens
deflated second balloon 14b disposed thereon are withdrawn of the catheter 116 , some of the lumens of the catheter 116 ,
through the valve 72 of the patch 70 ( see FIGS . 4B and 4C ) or all of the lumens of the catheter 116. In one embodiment,
such that the patch 70 remains fixed over the LAA ostium the lumen of each needle wire 121 is in communication with
( see FIG . 7B ) . each of the lumens of the catheter 116. In this manner , a first
As shown in FIG . 4C , withdrawing the shaft 12 through 40 lumen of the catheter 116 may provide a suctional force
the valve 72 leaves the valve 72 in the closed position , through the lumen of the needle wire 121 , and a second
thereby forming a barrier impenetrable to fluid and fully lumen of the catheter 116 may provide delivery of an
isolating the LAA from the left atrium . Accordingly, after the adhesive or medicament through the lumen of the needle
shaft 12 and balloons 14a , 14b are withdrawn , the patch 70 wire 121. Alternatively, and in the same manner, a first
is completely sealed off and thus flattens and covers any 45 lumen of the catheter 116 may provide a first adhesive to the
residual LAA cavity that may be present. It will be noted that needle wire 121 and aa second lumen of the catheter 116 may
the adhesive 47 within the LAA cavity may adhere to the provide a second adhesive to the needle wire 121 .
portion of the patch 70 spanning the LAA ostium and, as As previously described, the needle wires 121 comprise a
such , facilitate the secure placement of the patch 70 over the distal aperture 123. The distal aperture 123 is in communi
ostium . Where desired , however, the appropriate side of the 50 cation with the lumen of the needle wire 118 , and as such ,
patch 70 may be pre -coated with adhesive or a similar in communication with the interior 134 of the catheter 116 .
substance to further promote the adherence of the patch 70 In this manner a magnetic glue - like substance can be
to the inner atrial wall . advanced through the interior of the catheter 116 , into the
Now referring to FIG . 8C , an additional embodiment of lumen of the needle wire 118 , and delivered to a targeted
an occlusion assembly 100 is shown. The occlusion assem- 55 tissue through the needle aperture 123. Alternatively, a
bly 100 comprises the shaft 12 and the balloon 14 , and a suctional force can be transmitted through the needle aper
catheter needle 118. The shaft 12 and the balloon 14 are ture 123. In one embodiment, the needle wires 121 are
configured identically to the shaft 12 and the balloon 14 of connected to an injection apparatus ( not shown ) for glue
the occlusion assembly 10. Accordingly, configuration of the delivery via the hollow interiors of the needle wires 121 , and
shaft 12 and the balloon 14 will not be described in detail 60 a vacuum source (not shown) to supply the requisite suction
with respect to the occlusion assembly 100 , and like refer- necessary to aspirate the LAA cavity.
ence numerals between FIGS . 1A - 2E and FIGS . 8A - 8D will The needle wires 121 may further have an expanded
refer to like components. memory. For example, the needle wires 121 may be initially
As shown in FIG . 5B , the catheter needle 118 of the closed and then expanded once exposed to a particular
occlusion assembly 100 comprises a catheter 116 compris- 65 temperature or other stimuli. In other words , the needle
ing a proximal end 130 , a distal end 132 , a hollow interior wires 121 may comprise an original configuration, which
134 , and one or more needle wires 121. The catheter 116 may include , without limitation , a bend and /or a curve in the
US 11,166,703 B2
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needle wires 121. When the needle wires 121 exhibiting shown in FIGS . 1A - 1E ) is thereafter introduced into the
their original configuration are positioned within the shaft LAA cavity and an adhesive biological glue is injected
12 , the original configuration may be altered (e.g. , the needle therein to achieve an adequate seal of the LAA ostium ( see
wires 121 may be straightened while positioned within the FIG . 8E).
interior of the shaft 12 ) . When the needle wires 121 are 5 The inflation of the balloon 14 is maintained during the
thereafter protracted from the distal end 22 of the shaft 12 , requisite sealing time and the catheter 16 is withdrawn from
the original configuration of the needle wires 121 may then the body through the shaft 12. The magnetic attraction
present itself. between the magnetite microbeads 57 on the epicardial
The occlusion assembly 100 may be used in conjunction surface of the LAA and the magnetite microbeads 57 dis
with an injection apparatus and a magnetic glue - like sub- 10 posed within the interior of the LAA functions to create a
stance capable of injection by the injection apparatus. The constricted and tightened LAA , thereby promoting the
injection apparatus may comprise any device capable of occlusion of the LAA ( see FIG . 8F ) .
advancing a magnetic glue - like substance into the needle Now referring to FIGS . 9A and 9B , another embodiment
wires 121. The magnetic glue - like substance may exert a of an occlusion assembly 200 is shown. The occlusion
sufficient magnetic force so that when the magnetic glue - like 15 assembly 200 comprises the shaft 12 and the balloon 14 , and
substance is positioned on the exterior wall of an atrial a catheter 216. The shaft 12 and the balloon 14 are config
appendage, the magnetic glue -like substance functions to ured identically to the shaft 12 and the balloon 14 of the
effectively collapse the structure of the atrial appendage . The occlusion assembly 10. Accordingly, configuration of the
magnetic glue - like substance can be composed of any com- shaft 12 and the balloon 14 will not be described in detail
monly used adhesive substance known in the medical arts. 20 with respect to the occlusion assembly 200 , and like refer
In operation, the occlusion assembly 100 , the shaft 12 and ence numerals between FIGS . 1A - 2E and FIGS . 9A - 9B will
balloon 14 are delivered and deployed as previously refer to like components.
described . Specifically , the balloon 14 is inflated and posi- In one embodiment, a catheter 216 is used in conjunction
tioned to collect occluding the ostium of the LAA . There- with the shaft 12 and the balloon 14 to collapse an atrial
after, the catheter needle 118 is delivered through the interior 25 appendage . The catheter 216 comprises a proximal end 220 ,
24 of the shaft 12 ( see FIG . 8A) and suction of the LAA a distal end 222 , and a clip assembly 250 extending from the
cavity is initiated . In one embodiment, the suction can be distal end 222 of the catheter 216. The clip assembly 250
provided through the needle apertures 123 of the needle comprises a magnetic bar 254 and a plurality of ferromag
wires 121. In an alternative embodiment, a vacuum source netic clips 255 positioned in an umbrella -like configuration.
can be applied directly to the proximal end 20 of the shaft 30 The magnetic bar 254 is removably coupled with the distal
12. The suctional force of the vacuum is maintained and /or end 222 of the catheter 216 such that once the clip assembly
increased until an amount of blood is removed from the 250 is anchored to a tissue , the catheter 216 can be removed
LAA cavity and the LAA wall collapses . Even after the wall therefrom and withdrawn from the body. Furt in least
collapses , a degree of suction is maintained through the one embodiment, the magnetic bar 254 initially comprises a
catheter 116 or the shaft 12 in order to ensure the balloon 14 35 sheath disposed thereon to prevent any magnetic attraction
maintains optimal position . between the ferromagnetic clips 255 and the magnetic bar
Under fluoroscopic and transesophageal echocardiogra- 254 prior to deployment of the device .
phy control, the catheter needle 118 is advanced through the Each of the ferromagnetic clips 255 comprising the clip
distal end 22 of the shaft 12 and the walls of the LAA are assembly 250 comprises a first end 230 and a second end
punctured with the needle wires 121 ( see FIG . 8D ) . The 40 232. In addition , each of the ferromagnetic clips 255 exhibits
needle wires 121 are capable of completely puncturing the a magnetic polarity. The second ends 232 of the ferromag
LAA wall , such that the needle apertures 123 of the needle netic clips 255 are hingedly coupled with the magnetic bar
wires 121 are positioned within the pericardial sac . Due to 254 , such that a hinged apex 257 is formed . From this hinged
the relatively thin nature of the needle wires 121 , the apex 257 , the clip assembly 250 is capable of moving
puncture of the LAA wall has minimal effect on the pressure 45 between a compressed position ( closed umbrella ) and an
within the LAA cavity. However, in one embodiment, the expanded position ( open umbrella ).
suctional pressure may be slightly increased during this step The ferromagnetic clips 255 are specifically arranged
to facilitate a constant pressure within the LAA cavity . around the magnetic bar 254 such that a magnetic force is
While the needle apertures 123 are positioned within the generated between the components of the clip assembly 250 .
pericardial sac , an amount of magnetite microbeads 57 are 50 However, for as long as the sheath is disposed on the
delivered through the needle apertures 123 of the needle magnetic bar 254 , the various components of the clip
wires 121 onto the epicardial surface . In one embodiment, assembly 250 may be easily maneuvered .
this delivery is achieved through the use of the injection When the clip assembly 250 is positioned in a compressed
apparatus previously described . The magnetite microbeads position , each of the ferromagnetic clips 255 lay substan
57 maybe delivered as an adhesive solution , a powder ,or as 55 tially parallel with the catheter 116 ( see FIG . 9A) . In
carbon dioxide spray. As shown in FIG . 8D , after the first addition , the apex 257 of the clip assembly 250 comprises a
application is complete, the needle wires 121 are used to needle - like surface that is capable of puncturing a targeted
puncture the LAA and deliver the microbeads 57 to the tissue . When the ferromagnetic clips 255 are positioned in
epicardial surface in multiple locations . Once a sufficient the expanded position , the first ends 230 of the clips 255
amount of magnetite microbeads 57 have been applied to the 60 extend radially from the magnetic bar 257 such that the
external surface of the atrial appendage, the needle catheter ferromagnetic clips 255 are positioned in the expanded
118 may be withdrawn through the shaft 12 and removed position ( see FIG . 9B ) .
from the body. Alternatively, prior to being withdrawn, the The umbrella - like configuration of the clip assembly 250
needle catheter 118 may deposit an amount of magnetite enables the clip assembly 250 to puncture a targeted tissue
microbeads 57 within the interior of the LAA cavity such 65 and subsequently anchor thereto . For example, when the
that the magnetite microbeads 57 are distributed between the ferromagnetic clips 255 are positioned in the compressed
LAA wall trabecules (pectinate muscles ). The catheter 16 (as position , the apex 257 of the clip assembly 250 can be used
US 11,166,703 B2
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to puncture the tissue of the LAA . Thereafter, the ferromag- The catheter 316 is then advanced, following the guide
netic clips 255 in the compressed position are advanced wire 18 , through the puncture in the LAA wall . Further, the
through the puncture hole and into the pericardial space . pigtail configuration of the catheter 316 is utilized to wrap
Once the first ends 230 of the ferromagnetic clips 255 clear around the base of the LAA , as shown in FIG . 13. At this
the puncture hole in the tissue , the catheter 216 is withdrawn 5 point, the guide wire 18 is withdrawn and removed , and the
through a pull - back technique. As the first ends 230 of the wire guide is advanced in its place . The wire guide functions
ferromagnetic clips 255 are not as tightly configured as are to push and deliver the short memory wire 320 to the base
the second ends 232 which form a needle - like tip , the first of the LAA. Accordingly, the wire guide effects the place
ends 230 cannot retract through the puncture hole in the ment of the memory wire 320 through pushing and pulling
tissue . Accordingly, the first ends 230 of the ferromagnetic 10 the memory wire 320 around the base of the LAA as shown
clips 255 expand radially away from the catheter 216 and in FIG . 14A . In this manner, the two ends of the memory
into the expanded position . wire 320 are crossed around the base of the LAA . Concur
The magnetic bar 254 remains positioned within the rent with the manipulation of the memory wire 320 , the
interior of the LAA . At this point, the sheath disposed on the catheter 316 is slowly withdrawn from the LAA cavity
magnetic bar 254 to prevent magnetic interaction between 15 through the shaft 12. Due to the shape memory alloy
the magnetic bar 257 and the ferromagnetic clips 255 is properties of the memory wire 320 and its placement around
removed . Once the sheath is removed , the magnetic attrac- the base of the LAA , the memory wire 320 effectively
tion between the components of the clip assembly 250 occludes the LAA without the use of adhesives or sutures .
causes the ferromagnetic clips 255 to move into the com- In at least an additional embodiment of a system for
pressed position , thereby applying pressure to the exterior of 20 occluding the LAA of the disclosure of the present applica
the LAA as shown in FIGS . 10A - 10C . In this manner, a tion , the system involves the use of two devices to perform
sandwich effect is created around the exterior of the LAA an exemplary LAA occlusion procedure. As shown in FIGS .
and the LAA cavity is caused to collapse . Once the desired 15 and 17 , an exemplary system 1600 comprises a first
collapse has been achieved, the catheter 216 may be device 1200 and a second device 1202. In at least one
uncoupled from the magnetic bar 257 ( through unscrewing 25 embodiment, first device 1200 comprises a tube 1204 and a
or some other means ) and withdrawn from the body. balloon 1208 coupled to tube 1204 , wherein the balloon
Now referring to FIGS . 11A - 14B , at least one embodi- 1208 is sized and shaped for insertion into the LAA cavity
ment of an occlusion assembly 300 is shown . As shown in 1206. In at least one exemplary embodiment, tube 1204 of
FIGS . 12 and 13 , the occlusion assembly 300 comprises the first device 1200 may comprise a transseptal balloon cath
shaft 12 , the balloon 14 , a catheter 316 , a needle wire 318 , 30 eter . Balloon 1208 , to perform the LAA occlusion procedure
and a memory wire 320. The shaft 12 and the balloon 14 are as disclosed in further detail herein , would be capable of
configured identically to the shaft 12 and the balloon 14 of inflation and deflation . Second device 1202 , in an exemplary
the occlusion assembly 10. Accordingly , configuration of the embo ment, comprises a tube 1210 sized and shaped for
shaft 12 and the balloon 14 will not be described in detail insertion into a patient, with the tube 1210 comprising a
with respect to the occlusion assembly 300 , and like refer- 35 lumen extending at least partially from the distal end to the
ence numerals between FIGS. 1A - 2E and FIGS . 11A - 14B proximal end of tube 1210. Second device 1202 , in an
will refer to like components. exemplary embodiment, further comprises a loop 1212 sized
As shown in FIGS . 12 and 13 , occlusion assembly 300 and shaped to fit at least partially within the lumen of tube
comprises a catheter 316 , a needle wire 318 , and a memory 1210 , wherein loop 1212 is capable of protraction from the
wire 320. The catheter 316 comprises a preformed pigtail 40 distal end of tube 1210. Loop 1212 may optionally be
catheter having a plurality of lumens . FIGS . 11A - 11C illus- coupled to a shaft 1214 at or near the distal end of shaft
trate various configurations of the catheter 316 , although the 1214 , whereby movement of shaft 1214 , when positioned
catheter 316 may comprise any other configuration capable with tube 1210 , would allow loop 1212 to protract and / or
of advancing the memory wire 320 through the base of the retract from the distal end ( opening ) of tube 1210. Tube
LAA . In one embodiment, the catheter 316 comprises three 45 1210 may comprise and / or function as an engagement
lumens : a first lumen coupled with a vacuum device, a catheter, and the loop 1212 / shaft 1214 portion of second
second lumen for receiving a guide wire , and a third lumen device 1202 may comprise and / or function as a delivery
for receiving the memory wire 320 and the needle wire 318 . catheter. First device 1200 and / or second device 1202 may
The memory wire 320 may be made of a shape memory be introduced into heart 1216 as described in detail herein .
alloy, such as nitinol . Thus , the wire 320 is relatively straight 50 An exemplary embodiment of a portion of a system for
when deployed through the catheter 316. However, after occluding an atrial appendage of the present disclosure is
introduction into the body and placement around the atrial shown in FIG . 16. As shown in FIG . 16 , and in an exemplary
appendage, by manipulating the wire to wrap around the embodiment, first device 1200 may comprise a suction /
appendage, the wire forms the shape of a loop . In one inflation source 1100 operably coupled to tube 1204 ,
embodiment, the memory wire 320 is relatively short and is 55 whereby operation of the suction / inflation source 1100 may
employed with a separate wire guide to facilitate accurate facilitate the inflation and / or deflation of balloon 1208
placement. coupled thereto . Suction / inflation source 1100 may also
The catheter 316 is delivered into the LAA and suction is operate to remove blood from an atrial appendage as refer
applied thereto as previously described herein . The needle enced herein regarding the description of FIG . 20C .
wire 318 is advanced through the. shaft 12 , and is used to 60 In at least an additional embodiment of a method for
puncture the base of the LAA , as shown in FIG . 12. After the occluding the LAA of the disclosure of the present applica
LAA wall is punctured, the atraumatic guide wire 18 is tion , the method involves the use of first device 1200 and
introduced into the puncture hole and advanced through the second device 1202 to perform the occlusion procedure. As
LAA wall and into the pericardial space . Once the puncture shown in FIG . 18A , at least one step of a method for
hole is maintained by the guide wire 18 , the needle wire 318 65 occluding an LAA 1300 comprises the introduction of first
is withdrawn back into the LAA and thereafter removed device 1200 into a heart and advancement of first device
from the body. 1200 into the right atrium 1302 of the heart. Such an
US 11,166,703 B2
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introduction may be performed under local anesthesia , and encircle LAA 1300 as shown in FIG . 18B by maneuvering
may also use conscious sedation techniques as known in the shaft 1214 so that loop 1212 encircles and engages LAA
art. First device 1200 may be introduced into the body using 1300. In at least one embodiment, balloon 1208 is kept
femoral or jugular venous puncture and then progressing inflated while loop 1212 is positioned around LAA 1300 as
first device into the right atrium 1302 of the heart. The 5 shown in FIG . 18B .
introduction of first device 1200 into the body may be After loop 1212 has encircled and engaged LAA 1300 ,
performed using transesophageal echocardiography and loop 1212 may be tightened around LAA 1300 as shown in
fluoroscopy so that the user of first device 1200 is able to FIG . 18C to facilitate LAA 1300 occlusion . As shown in
advance first device 1200 into the right atrium 1302 of the FIG . 18C , loop 1212 has been tightened around LAA 1300
heart. 10 during or after the deflation of balloon 1208 and removal of
After first device 1200 is positioned within the right the portion of first device 1200 present within LAA cavity
atrium 1302 of the heart, transseptal puncture at the level of 1206 while balloon 1208 was inflated . After loop 1212 has
the fossa ovalis area may be performed to advance at least been tightened around LAA 1300 , loop 1212 is separated
a portion of first device 1200 through the atrial septum 1304 from shaft 1214 , or from the portion of second device 1202
of the heart into the left atrium 1306 of the heart as shown 15 to which loop 1212 is connected, so that second device 1202
in FIG . 18A . The step of transseptal puncture may be may be removed from the body. Loop 1212 may be sepa
performed using a standard transseptal sheath kit as known rated from the remainder of second device 1202 by, for
in the art . The administration of heparin to the patient prior example, the use of an electromagnetic current to separate
to transseptal puncture may increase the activated clotting loop 1212 , a turning maneuver ( clockwise or counterclock
time above 250 seconds . 20 wise ) to separate loop 1212 , or other means known in the art
As shown in FIG . 18A , a portion of first device 1200 has to separate a portion of a device from the remainder of the
advanced through a puncture within atrial septum 1304 , and device .
balloon 1208 of first device 1200 has been positioned within After the portion of first device 1200 previously present
the LAA cavity 1206. The distal end of first device 1200 may within LAA cavity 1206 has been removed from LAA cavity
be advanced into the LAA cavity 1206 by the use of a guide 25 1206 , first device 1200 may be retracted through the punc
wire (not shown) using procedures known in the art, for ture within atrial septum 1304 , and may be completely
example, to advance catheters within a body with the use of removed from the body from , for example, the original
a guide wire . femoral or jugular venous puncture site . Second device 1202
At least one additional step of a method to perform an may be removed from the body, either before, during, or
LAA occlusion of the present disclosure involves the infla- 30 after the removal of first device 1200 , with the portion of
2
tion of balloon 1208 as shown in FIG . 18B . As shown in second device 1202 present within the pericardial space
FIG . 15B , balloon 1208 has been inflated to occupy most or 1308 of the heart being removed from the pericardial space
all of the LAA cavity 1206 and to displace blood present 1308 from the original site of entry into the pericardial space
within the LAA cavity 1206 prior to inflation . Balloon 1208 1308. An anti -platelet adhesive treatment may be provided
may be inflated using an inflation / suction source ( shown in 35 to the patient during or after the procedure to facilitate heart
FIG . 16 ) operably coupled to tube 1204 of first device 1200 , healing from trauma incurred during the procedure to facili
whereby introduction of a gas and / or a liquid from the tate LAA occlusion .
inflation / suction source 1100 through the lumen of tube It can be appreciated that one or more of the aforemen
1204 into balloon 1208 coupled to tube 1204 causes balloon tioned steps may be performed in an order not explicitly
1208 to inflate / expand. To facilitate such inflation /expan- 40 disclosed above . For example, the placement of loop 1212
sion, at least one aperture (not shown) would be defined around the LAA 1300 may be performed prior to the
within a portion of tube 1204 surrounded by balloon 1208 so inflation of balloon 1208 .
that a gas and / or a liquid present within the lumen of tube In at least another embodiment of a system for occluding
1204 would be able to enter balloon 1208. Similarly, the the LAA of the disclosure of the present application, the
deflation of balloon 1208 , as described in further detail 45 system also involves the use of two devices to perform an
below , may be facilitated using suction generated by the exemplary LAA occlusion procedure. As shown in FIG . 19 ,
inflation /suction source 1100 to remove at least a portion of an exemplary system comprises a first device 1200 and a
the gas and /or liquid present within an inflated balloon 1208 . second device 1202. In at least one embodiment, first device
As shown in FIG . 18B , loop 1212 of second device 1202 1200 comprises a tube 1204 and a balloon 1208 coupled to
is capable of encircling LAA 1300 while balloon 1208 of 50 tube 1204 , wherein the balloon 1208 is sized and shaped for
first device 1200 is inflated within the LAA cavity. Second insertion into an entrance of the LAA cavity 1400 rather than
device 1202 may be introduced into the patient using similar entry of most or all of balloon 1208 into LAA cavity 1206 .
techniques as described herein for the introduction of first In at least one exemplary embodiment, tube 1204 of first
device 1200. After at least a portion of second device 1202 device 1200 may comprise a transseptal balloon catheter.
has entered the heart or approached the area of the heart, the 55 Balloon 1208 , to perform the LAA occlusion procedure as
distal end of second device 1202 could be advanced into the disclosed in further detail herein , would be capable of
pericardial sac using methods known in the art for the inflation and deflation .
introduction of second device 1202 , or a portion of second Second device 1202 , in an exemplary embodiment, com
device 1202 , as described herein . For example, second prises a tube 1210 sized and shaped for insertion into a
device 1202 may comprise an engagement catheter and a 60 patient, with the tube 1210 comprising a lumen extending at
delivery catheter /mechanism , wherein the engagement cath- least partially from the distal end to the proximal end of tube
eter engages a heart wall , allowing the delivery catheter / 1210. Second device 1202 , in an exemplary embodiment,
mechanism to puncture the heart wall and enter into the further comprises a loop 1212 sized and shaped to fit at least
pericardial space , in at least one exemplary embodiment, at partially within the lumen of tube 1210 , wherein loop 1212
least a portion of second device 1202 , comprising loop 1212 65 is capable of protraction from the distal end of the tube 1210 .
coupled to shaft 1214 , may enter into the pericardial space Loop 1212 may be coupled to a shaft 1214 at or near the
2
1308 as shown in FIG . 18B . Loop 1212 may then be used to distal end of shaft 1214 , whereby movement of shaft 1214 ,
US 11,166,703 B2
23 24
when positioned with tube 1210 , would allow loop 1212 to to remove at least a portion of the gas and / or liquid present
protract and / or retract from the distal end ( opening) of tube within an inflated balloon 1208 .
1210. Tube 1210 may comprise and / or function as an As shown in FIG . 20B , loop 1212 of second device 1202
engagement catheter, and the loop 1212 / shaft 1214 portion is capable of encircling LAA 1300 while balloon 1208 of
of second device 1202 may comprise and /or function as a 5 first device 1200 is inflated to occlude the entrance of the
delivery catheter. First device 1200 and / or second device LAA cavity 1400 , Second device 1202 may be introduced
1202 may be introduced into heart 1216 as described in into the patient using similar techniques as described herein
detail herein . for the introduction of first device 1200. After at least a
In at least an additional embodiment of a method for portion of second device 1202 has entered the heart or
occluding the LAA of the disclosure of the present applica- 10 approached the area of the heart, the distal end of second
tion, the method involves the use of first device 1200 and device 1202 could be advanced into the pericardial space
second device 1202 to perform the occlusion procedure . As using methods known in the art for the introduction of
shown in FIG . 20A , at least one step of a method for second device 1202 , or a portion of second device 1202 , as
occluding an LAA 1300 comprises the introduction of first 15 described herein . For example, second device 1202 may
device 1200 into a heart and advancement of first device comprise an engagement catheter and a delivery catheter /
1200 into the right atrium 1302 of the heart. Such an mechanism , wherein the engagement catheter engages a
introduction may be performed under local anesthesia, and heart wall , allowing the delivery catheter /mechanism to
may also use conscious sedation techniques as known in the puncture the heart wall and enter into the pericardial space .
art . First device 1200 may be introduced into the body using 20 In at least one exemplary embodiment, at least a portion of
femoral or jugular venous puncture and then progressing second device 1202 , comprising loop 1212 coupled to shaft.
first device 1200 into the right atrium 1302 of the heart. The 1214 , may enter into the pericardial space 1308 as shown in
introduction of first device 1200 into the body may be FIG . 20B . Loop 1212 may then be used to encircle LAA
performed using transesophageal echocardiography and 1300 as shown in FIG . 20B by maneuvering shaft 1214 so
fluoroscopy so that the user of first device 1200 is able to 25 that loop 1212 encircles and engages LAA 1300. In at least
advance first device 1200 into the right atrium 1302 of the one embodiment, balloon 1208 is kept inflated while loop
heart. 1212 is positioned around LAA 1300 as shown in FIG . 20B .
After first device 1200 is positioned within the right After loop 1212 has encircled and engaged LAA 1300 ,
atrium 1302 of the heart, transseptal puncture at the level of loop 1212 may be tightened around LAA 1300 as shown in
the fossa ovalis area may be performed to advance at least 30 FIG . 20C to facilitate LAA 1300 occlusion . As shown in
a portion of first device 1200 through the atrial septum 1304 FIG . 20C , loop 1212 has been tightened around LAA 1300
of the heart into the left atrium 1306 of the heart as shown during or after the deflation of balloon 1208 and removal of
in FIG . 20A . The step of transseptal puncture may be the portion of first device 1200 present within LAA cavity
performed using a standard transseptal sheath kit as known 1206 while balloon 1208 was inflated . After loop 1212 has
in the art. The administration of heparin to the patient prior 35 been tightened around LAA 1300 , loop 1212 is separated
to transseptal puncture may increase the activated clotting from shaft 1214 , or from the portion of second device 1202
time above 250 seconds . to which loop 1212 is connected, so that second device 1202
As shown in FIG . 20A , a portion of first device 1200 has may be removed from the body. Loop 1212 may be sepa
advanced through a puncture within atrial septum 1304 , and rated from the remainder of second device 1202 by, for
balloon 1208 of first device 1200 has been positioned at the 40 example, the use of an electromagnetic current to separate
entrance of the LAA cavity 1400. The distal end of first loop 1212 , a turning maneuver ( clockwise or counterclock
device 1200 may be advanced to the entrance of the LAA wise ) to separate loop 1212 , or other means known in the art
cavity 1400 by the use of a guide wire (not shown) using to separate a portion of a device from the remainder of the
procedures known in the art, for example , to advance device .
catheters within a body with the use of a guide wire . 45 After the portion of first device 1200 previously occluding
At least one additional step of a method to perform a LAA the entrance of the LAA cavity 1400 has been removed , first
occlusion of the present disclosure involves the inflation of device 1200 may be retracted through the puncture within
balloon 1208 as shown in FIG . 20B . As shown in FIG . 20B , atrial septum 1304 , and may be completely removed from
balloon 1208 has been inflated to occlude the entrance of the the body from , for example, the original femoral or jugular
LAA cavity 1400 , whereby suction from an inflation / suction 50 venous puncture site . Second device 1202 may be removed
source 1100 ( shown in FIG . 16 ) operably coupled to tube from the body, either before, during, or after the removal of
1204 of first device 1200 allows blood present within the first device 1200 , with the portion of second device 1202
LAA cavity prior to occlusion of the entrance of the LAA present within the pericardial space 1308 of the heart being
cavity 1400 to be removed , facilitating the effective collapse removed from the pericardial space 1308 from the original
of LAA cavity 1206. Balloon 1208 may be inflated using an 55 site of entry into the pericardial space 1308. An anti-platelet
inflation / suction source 1100 ( shown in FIG . 16 ) operably adhesive treatment may be provided to the patient during or
coupled to tube 1204 of first device 1200 , whereby intro- after the procedure to facilitate heart healing from any
duction of a gas and / or a liquid from the inflation / suction trauma incurred during the procedure to facilitate LAA
source 1100 through the lumen of tube 1204 into balloon occlusion .
1208 coupled to tube 1204 causes balloon 1208 to inflate / 60 Exemplary systems for occluding an LAA are shown in
expand. To facilitate such inflation / expansion, at least one FIGS . 21A and 21B . As shown in FIG . 21A , system 1600
aperture (not shown) would be defined within a portion of comprises a guide wire 1602 , a first device 1200 , and a
tube 1204 surrounded by balloon 1208 so that a gas and / or second device 1202. In this exemplary embodiment, first
a liquid present within the lumen of tube 1204 would be able device 1200 comprises tube 1204 and balloon 1208 coupled
to enter balloon 1208. Similarly, the deflation of balloon 65 thereto , and second device 1202 comprises tube 1210 , loop
1208 , as described in further detail below, may be facilitated 1212 , and shaft 1214. This exemplary system 1600 may be
using suction generated by the inflation / suction source 1100 used to perform the steps for occluding an LAA as disclosed
US 11,166,703 B2
25 26
in detail herein . In an additional embodiment, second device The invention claimed is :
1202 may comprise tube 1210 and loop 1212 , but not shaft 1. A device for occluding an atrial appendage of a heart
1214 . comprising:
An additional exemplary embodiment of a system for a single tubular shaft sized and shaped for insertion into
occluding an LAA is shown in FIG . 21B . As shown in FIG . 5 a heart , the shaft comprising a proximal end, an open
21B , system 1600 comprises a first device 1200 and a distal end , and at least one lumen extending therebe
second device 1202 , and in this exemplary embodiment, first tween ;
device 1200 comprises tube 1204 and balloon 1208 coupled a first balloon and a second balloon coupled to the distal
thereto , and second device 1202 comprises tube 1210 , loop end of the shaft, the balloons configured for inflation
1212 , and shaft 1214. In this exemplary embodiment, sys- 10 and deflation independently of each other, the second
tem 1600 does not include guide wire 1602 . balloon positioned distally on the shaft relative to the
Another exemplary embodiment of a second device 1202 first balloon , and each balloon having a diameter per
is shown in FIG . 21C . As shown in FIG . 21C , second device pendicular to the shaft;
1202 comprises tube 1210 , loop 1212 , and shaft 1214. In this a patch disposed on said shaft and between the first
exemplary embodiment, loop 1212 is not a permanently 15 balloon and the second balloon , wherein the patch is
" closed " loop , which may facilitate the encircling of an atrial disposed on said shaft independently of the first and the
appendage prior to closing said loop 1212 . second balloons , wherein the patch remains positioned
Many benefits and advantages to using systems and between the first balloon and the second balloon until
performing methods of the present disclosure exist, noting after the patch is deployed;
that said procedures are minimally invasive and may be used 20 wherein the patch is removably coupled with the distal
by all patients regardless of patient age and /or condition . end of the shaft, the patch configured to occlude an
Such methods avoid the need for surgery and further avoid ostium of an atrial appendage when positioned there
the need of intracardiac or other implantable devices. In over ;
addition , the devices comprising the systems of the present a catheter sized and shaped for slidable insertion into the
disclosure replace the use of other oversized devices (which 25 lumen of the shaft, the catheter comprising a proximal
may be , for example, 20 % to 50 % larger than the ostium of end, a distal end having at least one opening , and at
an LAA as measured by angiography and other methods), least one lumen extending between the proximal and
which prevents the risk of LAA tissue overdistentation distal ends thereof;
( circumflex coronary artery distortion or compression ). Such an adhesive delivery device coupled with the proximal
procedures also avoid the possible leakage around the 30 end of the catheter and in communication with at least
devices, the risk of thrombus formation, and the migration , one lumen of the catheter; and
erosion, or perforation of the LAA . In addition to the at least one optical fiber disposed within the at least one
foregoing, said methods also avoid mitral valve damage, lumen of the catheter and configured emit light
pulmonary venous obstruction, the risk of infections endo- having a range of wavelengths, wherein when light is
carditis, and the use of anticoagulation therapy. 35 emitted from the at least one optical fiber, the light is
While various embodiments of devices, systems , and communicated through the at least one opening of the
methods for occluding an atrial appendage have been distal end of the catheter.
described in considerable detail herein , the embodiments are 2. The device of claim 1 , further comprising a suction
merely offered by way of non- limiting examples. Many source coupled with the proximal end of the catheter and in
variations and modifications of the embodiments described 40 communication with at least one opening of the distal end of
herein will be apparent to one of ordinary skill in the art in the catheter.
light of the disclosure . It will therefore be understood by 3. The device of claim 2 , wherein the at least one lumen
those skilled in the art that various changes and modifica- of the catheter comprises at least a first lumen , a second
tions may be made , and equivalents may be substituted for lumen, and a third lumen , and wherein the suction source is
elements thereof, without departing from the scope of the 45 in communication with the first lumen , the adhesive delivery
disclosure . Indeed , this disclosure is not intended to be device is in communication with the second lumen , and the
exhaustive or to limiting . The scope of the disclosure is to he at least one optical fiber is positioned within the third lumen
defined by the appended claims , and by their equivalents. such that suction, adhesive, and light may each be applied
Further, in describing representative embodiments, the through the at least one opening of the distal end of the
disclosure may have presented a method and / or process as a 50 catheter independently of the others, concurrently therewith ,
particular sequence of steps . However, to the extent that the or in any combination thereof.
method or process does not rely on the particular order of 4. The device of claim 1 , wherein the first balloon
steps set forth herein , the method or process should not be comprises a disc - shaped configuration and the second bal
limited to the particular sequence of steps described . As one loon comprises a conical - shaped configuration .
of ordinary skill in the art would appreciate, othersequences 55 5. The device of claim 1 , wherein the patch is removably
of steps may be possible . Therefore , the particular order of coupled with the distal end of the shaft via a valve and the
the steps disclosed herein should not be construed as limi- valve is biased to self - close when the patch is uncoupled
tations on the claims . In addition, the claims directed to a from the shaft.
method and / or process should not be limited to the perfor- 6. The device of claim 1 , wherein the patch is comprised
mance of their steps in the order written, and one skilled in 60 ofa? material selected from the group consisting of polytet
the art can readily appreciate that the sequences may be rafluoroethylene, polyurethane, silicone rubber, Dacron , and
varied and still remain within the spirit and scope of the biologic material.
present disclosure. 7. The device of claim 6 , wherein the material comprises
It is therefore intended that this description and the a resorbable material.
appended claims will encompass , all modifications and 65 8. The device of claim 1 , wherein the light comprises
changes apparent to those of ordinary skill in the art based ultraviolet light having a range of wavelengths between
on this disclosure . about 300 nm and about 400 nm .
US 11,166,703 B2
27 28
9. The device of claim 1 , wherein : 13. The method of claim 11 ,
the first balloon , when positioned over an entrance of an further comprising the steps of:
atrial appendage cavity , is capable of inflation to inflating the second balloon within the entrance of the
occlude the entrance of the atrial appendage cavity; and atrial appendage cavity to occlude the same;
the second balloon is sized and shaped to fit within the 5 inflating the first balloon over the entrance of the atrial
entrance of the atrial appendage cavity and, when appendage cavity to occlude the same ;
positioned therein , is capable of inflation to occlude deflating the second balloon ;
same . withdrawing the distal end of the catheter from the atrial
10. The device of claim 1 , further comprising a guidewire appendage cavity while continuing to deliver adhesive
to facilitate insertion of the shaft into a heart and /or the 10 thereto through the at least one opening in the distal end
catheter into the atrial appendage cavity. of the catheter;
11. A method for occluding an atrial appendage of a heart, deflating the first balloon ; and
the method comprising the steps of: withdrawing the shaft and first and second balloons from
introducing at least a portion of a device into an atrial the heart.
appendage cavity of a heart, the device comprising: 15 14. The method of claim 11 , further comprising the step
a single tubular shaft sized and shaped for insertion into of collapsing the atrial appendage cavity.
a heart, the shaft comprising a proximal end, an open from 15. The method of claim 11 , wherein the light emitted
-
distal end, and at least one lumen extending therebe havingthea atrange least one optical fiber comprises ultraviolet light
of wavelengths between about 300 nm and
tween,
a first and a second balloon coupled to the distal end of 20 about
16.
400 nm .
The method of claim 11
the shaft, the balloons configured for inflation and further comprising the steps of:
deflation independently of each other, the second securing the patch over the ostium of the atrial append
balloon positioned distally on the shaft relative to the age cavity, and
first balloon, and each balloon having a diameter decoupling the patch from the shaft.
perpendicular to the shaft, 25
a patch disposed on said shaft and between the first ably17.coupled The method of claim 16 , wherein the patch is remov
with the distal end of the shaft via a valve and
balloon and the second balloon , wherein the patch is the valve is biased
disposed on said shaft independently of the first and from the shaft. to self -close upon decoupling the patch
the second balloons , wherein the patch remains 18. A device for occluding an atrial appendage of a heart
positioned between the first balloon and the second 30 comprising :
balloon until after the patch is deployed, a single tubular shaft sized and shaped for insertion into
wherein the patch is removably coupled with the distal a heart , the shaft comprising a proximal end, an open
end of the shaft, the patch configured to occlude an distal end, and at least one lumen extending therebe
ostium of an atrial appendage when positioned there tween ;
over ; 35
a first balloon and aa second balloon coupled with the distal
a catheter sized and shaped for slidable insertion into end of the shaft, the first and second balloons each
the lumen of the shaft, the catheter comprising a configured for inflation and deflation independently of
proximal end coupled with an adhesive delivery the other, the second balloon positioned distally on the
device and a suction source , a distal end having at shaft relative to the first balloon , and each balloon
least one opening, and at least one lumen extending 40 having a diameter perpendicular to the shaft;
between the proximal and distal ends thereof, and a patch removably coupled with the distal end of the shaft
at least one optical fiber disposed within the at least one and disposed on said shaft and between the first and
lumen of the catheter and configured to emit light
having a range of wavelengths, wherein when light second balloons , wherein the patch is disposed on said
is emitted from the at least one optical fiber, the light 45 shaft independently of the first and the second balloons ,
is communicated through the at least one opening of the patch configured to occlude an ostium of an atrial
the distal end of the catheter; appendage when positioned thereover, wherein the
advancing the distal end of the shaft within an entrance of patch remains positioned between the first balloon and
the atrial appendage cavity ; the second balloon until after the patch is deployed;
inflating the second balloon to occlude the entrance of the 50 a catheter sized and shaped for slidable insertion into the
atrial appendage cavity; lumen of the shaft, the catheter comprising a proximal
aspirating the atrial appendage cavity via operation of the end, a distal end having at least one opening , and at
suction source ; least one lumen extending between the proximal and
delivering adhesive to the atrial appendage cavity through distal ends thereof;
the at least one opening in the distal end of the catheter ; 55 an adhesive delivery device coupled with the proximal
and end of the catheter and in communication with at least
sealing the atrial appendage cavity by curing the adhesive one lumen of the catheter;
therein with light emitted from the at least one optical a suction source coupled with the proximal end of the
fiber . catheter and in communication with at least one open
12. The method of claim 11 , further comprising the steps 60 ing of the distal end of the catheter; and
of: at least one optical fiber disposed within the at least one
withdrawing the distal end of the catheter from the atrial lumen of the catheter and configured to emit light
appendage cavity while continuing to deliver adhesive having a range of wavelengths, wherein when light is
thereto through the at least one opening in the distal end emitted from the at least one optical fiber, the light is
of the catheter; 65 communicated through the at least one opening of the
deflating the second balloon ; and distal end of the catheter.
withdrawing the shaft and balloons from the heart. * * *

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US011166703B2

Related U.S. Application Data 202570086 (2013.01 ) ; A61M 2025/0096

LAA ( completely occluded )

FIG . 11A MUHNSTAT ?WENHAN#??

numa t inet erie

FIG . 18A FIG . 18B

FIG . 20A FIG . 20B

occlusion assembly of FIGS . 1A and 1B as applied to treat disclosure positioned therein ;

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