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    Stent Piezo patent

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    Stent Piezo patent

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    Stent Piezo 02052009 Pat20090036975

    Uploaded by

    markanapier
    Stent Piezo patent

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    © All Rights Reserved
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    'US 20090036975A1 us United States v2) Patent Application Publica Ward et al. (34) SELE-SENSING s' MATERIALS-BASI (76) Inventors: Kevin Ward, Richmond, VA (US): Zoubeida Ounaies, Richmond, VA (US): George Vetrovee, Richmond, VAs) Comesponlence Address WHITHAM, CURTIS & CHRISTOFFERSON & COOK, PC. 11491 SUNSET HILLS ROAD, SUITE 440 RESTON, VA 20190 (US) (21) Appl. No. PCT Filed: (ON (10) Pub. No.: US 2009/0036975 Al (43) Pub, Date Feb. 5, 2009 (86) PCT No PCT/AS2006I06 18 S371 00, (2), (Dawe: Sep. 3, 2008 Related US. Application Data (60) Provisional aplication No, 601749,092, ile on Dev. 12,2008. Publication Classification (1) Ine ASIF 306 200501) (2) US.CL 623/118; 6231.15; 625/1.42 on ABSTRACT A medically implantable stent comprising atleast one piczo lectric material may be active, such as by oe of more of Seliverng an anticoagulant or other therapetic effect to a patiet in which tis implanted: powering itself andor send- Jngan ourbounc electronic signal toa remote device, When sent can send such an outbound signal, a physician may ‘non-invasively ascertain the condition ofthe tissue near the 901 PATIENT TISSUE 91 900 3 902 STENT REMOVE SIGNAL RECEIVER Feb. 5,2009 Sheet 1of12 US 2009/0036975 Al Patent Application Publication YaAIZ934 TWNOIS SAOWSY SNssiL LNAlLWd 406 Feb. 5,2009 Sheet 2of12 US 2009/0036975 Al Patent Application Publication YSAIZ93N WNOIS SAOWSY 206 VE aunbl4 SNSsiL LNAlLWd Patent Application Publication [Pous Coating] —| (PDE Sampis } [Tirnestwat ortube y Artery tube Feb. 5, 2009 Sheet 3 of 12 PVDF Vota je Response: Sample ‘Altached with Coating of POMS. 200, Aplin ah Figure 2 caeaas “Time (680) Pressure (meng) PVDF Voltage (¥) Energy Harvesting Circuitry needed assive components). US 2009/0036975 AI Patent Application Publication Feb. 5, 2009 Sheet 4 of 12. US 2009/0036975 Al BYE Votage Response: San ‘Atachod wth Costing of POR 29 (Pous Coane] —| (Par Sanpe t ——> 60 ([Tinmestwarorupe-yL_Mten be “ Pressure (remit) ‘Welees I ‘Agsplay ewe’ “Tie (600) Bressure (rena) LL evoF Vvotage (¥) Wireless Roveiver System “Apter Ce ‘AID Converter erocentoen Figure 3 US 2009/0036975 AI Feb. 5, 2009 Sheet 5 of 12 Patent Application Publication 'e1Q J0}e/0U89 uonoUN, bp aunbl4 B}eQ qUaLINg 40 s6ey0A fa J9y810U85 wOHoUN dung dmesg sejeUORIey . can bey 7A 2aR LoTR SeUTT] oe aides JGAd |___. [Buneoo swag] uoRo8S $5075 San, Patent Application Publication Feb. 5, 2009 Sheet 6 of 12 US 2009/0036975 AI zoo ___PVOF Wotage Response: Sampo tached wih Coating of POMS 150 100 Pressure (mmHg) 50 an rere TATE 08 Pressure Pos Tbe Cos sect ressure (mmHg) ‘Time (sec) vO nace 'VOF Voltage () [POMS Coating | —} Figure 5 (irinwestwalotume yA" wee Patent Application Publication Feb. 5,2009 Sheet 70f 12 US 2009/0036975 Al PVDF Charge Response: Sample Attached with Coating of POMS 200 ° 180 2e-10 40-10 100 Pressure (mmHg) (0) eB:e49. 1] te-10 -Be-10 10 " 2 13 14 15 Time (sec) Pressure (mmHg) — PVDF Charge (C) Figure 6 US 2009/0036975 AI Feb. 5, 2009 Sheet 8 of 12 Patent Application Publication Z eunbi4 (Gyuu) eBuey essed ost 08k Ske 08 09 ov oz : 0 vo ZF é zo @ 2 cod vo & & so 8 xse000 = 4 s 90 £0 Buey ainssaig “SA OBRHON Herd OBBIONY 89s'0 oat ozogt 880970 oer ozost e1oze'o oor ozozt aunBy. veel 09 0z/08 v2 td (1 eB enn (yun) oo ‘dd aBeleny abuey ainssarg Patent Application Publication Feb. 5, 2009 Sheet 9 of 12 US 2009/0036975 AI Pressure Range vs. Average Pk-Pk ChargelArea 2.50E-06 2,006-08 + 1.80606 1,006.06 ‘Average Pk-Pk ChargelArea (Cilm*2) 5.00607 0.00+00 ° 2 4 6 8 100 120 40 160 180 Pressure Range (mmHg) Figure 8 Patent Application Publication Feb. 5, 2009 Sheet 10 of 12. US 2009/0036975 Al ©) ‘Average Pk-Pk Cha 3506-10 3006-10 2.5060 2.00610 1.506-10 1.006-10 5006-11 0.006400 Pressure Range vs. Average Pk-Pk Charge 2 40 60 e100] Pressure Range (mmHg) Figure 8A 180 Patent Application Publication Feb. 5,2009 Sheet 11 of 12 US 2009/0036975 Al Pressure Range vs, Average PK-Pk Current 2806-08 2.006-08 1506-08 | ‘Average PLP Cur +.00E-08 | 5,006.08 cc CE ee ee ee ee ee ee) Pressure Range (mm) Figure 8B Patent Application Publication Feb. 5, 2009 Sheet 12 of 12 US 2009/0036975 Al pz 10 USEABLE = N a L ~ ‘levzic material; te. The pievo-clecri material may be sit ated in, on of near the biologie structure, and in different ‘embodiments may directly or indirsetly contact the biologic structure. In this setting the piezo-electtie material isharvest- ing energy from its surounding which may be used to monic tor or control the surroundings 10052] Thestep of situating the piezo-electric material with respect to the biologic structure is followed by a step of ‘converting (200) the energy’ (Frz) generated by the pie7o- ‘lecric intercon io energy (Fn) dseable for pentering an application or storable for Iaer use powering an spplica- tion, such as enerzy useable for powering an antenna, eneesy useable for powering circuitry, et. 10053] The invention may be appreciated with reference to the following examples, without the invention being limited to the examples, EXAMPLE 10084) In this example, “smart” biomaterials are used that allow their implantation and measurement of intavasculae flow and pressure. This stent design is based on piezoelectric materials. Sensing capabilities are incorporated either intin- sc tothe stent or coupled tothe sent 10085] | Once the stent ofthis example is placed inpatient itis interrogated periodically to ensure tat blood is owing through the artery. Flow velocity and pressure are 10 vari ables that are targeted, This interrogation is aecomplished emote. An antenna is integrated with the device to take the sensor signal and transfer the signal info an electromagnetic nal. which is then transmitted outside the body and picked up remotely. 10056] Based on these principles, its possible to monitor ‘ther aspects of myocurtial funetion from the stent, This ‘includes bt isnot imitedto contractility parameters fom the ‘coronary artery-myocandial surfice 10087] Because some stents are placed angiographically using left heart catheterization, piezoslectric materils/de- viees may beattached to theaseending aorta to measure aortic pressure and flow (cardiac outpat)or within the let ventricle {o measure intrventricular pressure. The same may be done jin the right heart using polmonary artery catheterization. These stents and materials also may be used for other vessels, Jncluing but aot Imited to the carotid and cerebral arteries. 10088] Features and advantages ofthis invention including ‘unigue features and advantages, are as follows 10059] 4 novel device tha resulls in dual sensing and actuation functions is provided, These functions can tither be present in the same device or be in close prox imity suchas ina layered configuration, 0060} novel stent design that permits intersl sensing designed to monitor cardiovascular and respiratory phe- ‘nomena is provided, [0061] A novel stent design based on piezoelectric poly- ‘mers and polymer composites which typically display high voltage response, wide frequency bandwidth and Nat frequency response is provided. 0062] The stent design allows continuous monitoring to detect blockage or ater changes in blood dynamics, Feb. 5, 2009 10063} The device can be miniturzel and ean corpo ‘ie the sensing nd actuation factions as well he circuitry needed to activate or aterrozate it remetely. {0064} The piezotetricpotymers and polymer com- posites are exile ap ean conform to Various shapes Sch as tubes. They have densities similar to water and living tissues, and are chemically inet, which makes them suitable foe implantation {0065} The piezoelectric polymers and polymer com: oats ne evo inpsince acing oat ving tse. {0066} The materials forse inthe stents are exible and lightweight, therefore the will result in patient is nif no wll thy atrfere withthe esl faction of arteries and ater vessels. {0067} Transduction process in piewoeecsc polymers and polymer composts is frequency and empertire responsive, and covers broad dynamie range {0068} The novel device makes possible eneray harvest- ing potent for sell-owering ceo powerremote Tune. 10069] the piezoelectric materials are compatible with IMEMS and nonodevice processing [W070] The novel device makes possible aplication ofa ‘voltage ata contolabl frequency, which would reset in surface vibraons which may con intrcton of the pcroelctic material with ood (r other Bui) by climinating blockage ox preventing blockage {0071} General microamp- 19 naneamp-o¢ misroeou Tomb tonanaeoulom levelnegativecurentisextremely ‘xivanageous ecamse clogging of the stent may be inhibited. In fe, it has been showa that a negative charge is extremely antithrombotilanicoagulatve/an- tiahesive and this might prevent restenosis if the pur pose ofthe implanted stent it © restore and maintain blood los 10 sve. Orientation of the dipoles of the piezoelectric material in eltionship to forces applied to {provide forthe polenta to produge a negative cuerat ‘orehuarge in response to staining a pisoslctrie mate- Fil. Orientation of the dipoles is accomplished. by Ksown means sich as aplication oa song DC ele tec field othe piezoeletrie materials which lin he dipoles. parallel to the eletie field. Increasing or ‘decreasing pressure pall tothe dipoles am a piezo- lectc material causes electrical chargeto be generated ‘which can be positive or newaive depending on the iezlosric coefficients ofthe particular piezoelectric materia. Inakition to thischarge existing at the surface ofthe stent, this charge can intr ow andor be stored if deste using necessary eletca components to pete form certain factions. Piesclectrcty being a inca ‘phenomenon that relates an applied mechanical timu- lus toa resulting clctcal change or curent, it follows thatthe magnitude of electrical charge or current pro- diced would ncrease or decrease depending whether ‘he magnitude of the pressure i ineeasng o decrease ing. Depending on the pierelectre coelicicnts of the nate if the pressure on the piemceetie material is parallel to the inal polarization, itera positive or hegative electrical potential is generated. A number of ‘options re wvailable to sustain continuous, smallampli- tude, negative curent, such 38, <3: {0072} (1) biasing the piezoelectric stent such thatthe ‘xlitionl stimu wil result in current esilating US 2009/0036975 AI the neyative domain. The result will be a negative eur- reat with an amplitude tht reaches @ minimum and & ‘maximum, following the frequency of the external stimu, 0073] (2) incorporating a diode bridge into the stent v0 prevent fluctuations of current into the positive range. [0074] (3)using signal conditioning to inver the sign of the cureat when it becomes postive. 0075] (4) storing the current harvested from the piez>- electric material, and releasing it after an AC to DC ‘conversion. The resulting DC current is then inverted if needed to yield a coatinvously negative current. 10076] The invention can be used for implanted intavascu- Jar monitoring of blood flood and pressure. Furthermore, polymers and polymer composites have high sensitivity, ‘which means they are efficient voltage generators in response to mechanical stimulus. When implanted, the seasor device transforms the mechanical energy duc to blood few, breath- ing or other physiologic functions into charge. The charge is stored and used to power up other implanted devices. 30m thinpiezoelectric polymer, 100m longand 2em wide, rolled around the thorax ofa patent breathing at the rate of 24min, ‘ean create power a8 high a8 S00 jW [Hausler et al, 1980, Proceedings of IEEE}, EXAMPL [0077] In this Example, esearch was focused onthe use of PVR and its ability to provide a link between mechanical stimulus and electrical output. PVDF refers to Poly(vi- rylidene fooride), which is 2 commercially available paly- mer, demonstrates piezoelectiity, both heat and electricity. and is highly non-reactive. Previous application of PVDF include: electrical and ehemical insula Tors, speakers, stnin gauges vollage sources, and various sensor applications [0078] An experimental sctup was established according to FIG. 10079] The following test was performed to test the effet ‘of the flow pressure range on the voltage response of the PVDE. The test was performed using PVDF ina coated con- figurationata frequency of | Hz. Data wastakenat each range and the average of the peak to peak voltage of 5 eycles was calculated, [0080] The results (see FIGS. 7-83) show that an increase fn the pressure range brings about an inerase in the PVDE voltage response, Furthermore, the data demonstrate that & negative charge is produced and this response i also linea The relationship is linear, as expected for @ piezoeectric~ driven response, [0081] For FIGS. 8,84, 8B, the txts were performed using the same setup (FIG. 10) and sample asthe test dane to attain pressure range versus peak to peak voltage, For FIG. 8, charge was measured and the divided by the electrode area of the sample (7520 mm). [0082] ‘The experimental data of this Example 2 show that aPYDF material (which is 1 commercially available pieao- ‘locric material) whon used witha simulated biologi strc ture (inthis example, PDMS material used to simulate an artery) demonstrates experimental reslt fom which to con- clude that when a stent comprising such materials is ‘implanted in a patient, such a sent woud he expected to self-power, exhibit anti-coagulant behavior, exhibit anti-ad- Feb. 5, 2009 hasive effect, and when fitted with a antenna be capable of sending electronic signals to receiver aot implanted in the patient. EXAMPLE 3 (SELF-POWERED STENT) [0083] A piezo-electric materil-contaning stent is fitted ‘With energy conversion andor energy storage components by Which pieso-clectricully oblsined energy (ie, energy ‘oblained via the piezo-eleercal interaction withthe tissve in ‘whieh the product will be implanted) isconverted to electrical signals and/or sored, Examples of energy conversion and energy storage components are, eg, capacitors, batteries, diodes, transformers, ete [o084| Circuitry is included for using the stored energy to power one or more energy-using components (such as, e43 releasing mechanism on a drug-containing reservoir, an Antenna; ec.) contained in, on, contiguous, near or separate {rom the stent, EXAMPLE [0085] In this inventive example, a stent is used to power itself or components/systems tht are contiguous or separate from it For example, thos stent in a cerebral or cofoaary artery (or the aorta) is used to harvest energy fom those sites ‘which is in turn used to power deviees (or charge batteries) ‘whieh may be shor distances away from it EXAMPLE 5 [0086] In this inventive example, piezoelectric materials fare wrapped around arteries oe othe biologie struciuees 10 harvest energy and direc the energy to other sources orto use the energy for monitoring the structure to which the piezo clectri materials are attache. [0087] "Our experimental data (see Example 2 and FIGS, 4-88) show thats recordable signal was proiaced by PVDE materials (ie, a piezo-electical material) wrapped around tubing (hich mimics the artery). Despite the piezo-electric ‘materials not having direct contact with the Tumea of the ‘tubing, a signal can still be recorded. Therefor, the invention provides extaluminal uses as wel as intrauminal uses. [0088] Thus for surmeries such as conmnary artery bypass rafting, arterial bypass surgeries ofthe leg, or carotid endar- terectomnies, the surgeon could wrap a piezoelectric film around the vessel which could serve the purpose of monitor jing blood low o other Function. The negative charge pro- duced in this ease would not be helpful tothe fumen of the vessel, bul the sensing function would still maintain its use- fulness. The material in this ease isnot being usedto stent the vessel open but instead 10 monitor the vessel [0089] "While the invention has been described in terms of | its prefered embodiments, those skilled inthe art will woos: that the invention can be practiced with modification the spirit and scope ofthe appended claims. We eli: 1. An ant-coogulative and/or antiadhesive stent compris ‘nga stent implantable into a living patient, the stent com prising atleast one negative-charge-producing surface, and {he stent delivering an anticoagulant effect andor an antiad- Ipsive effect tothe patient in which te stent is implanted. 2. The stent of claim 1, comprising at Teast one signal- producing component. 3. Thestent of claim 2, wherein thesignal-producing com produces a recordable signal. US 2009/0036975 AI 4. The stent of laim 1, co Fil 5, The stent of claim 1, wherein the at lest one negative: _charge-prodicing surface comprises atleast ane piem-leo~ tric material orientation of which is arranged to produce @ ‘certain negative charge. 6. The stent of claim 1, comprising a drug-cluting stent. 7. The stent of elsny 1, comprising a smart stent. 8, The stent of claim 1, comprising a siznal-transmitter transmitting an electrical signal a distance in range of about To2 feet or more 9, The stent of claim 1, comprising a recordable voltage ‘output, wherein the recordable voltage outputs proportional tot least one function or property ofa issue where the stent is situate. 10, The stent of claim, wherein the st eastone Fanetion oF property is selected from the group consisting of: low, pres- sure, force, and temperature 11. The stent of claim 1, comprising at least one piezo- ‘electie material and a recordable voltage output from inter- action between the piezo-electric material and 8 material in ‘contact withthe piezo-electric material 12, The stent of claim 1, comprising # sel- powered stent. 13, The stent of lsim 12, comprising at least one pharma ‘ceutical substance or other substance releasable from the stent and releasing mechanist for releasing the substance wherein te releasing mechanism is powered interaction a piezoelectric material with a tissue in which the stent is situated, 14. The stent of claim 1, comprising a least one selected Jom the group consisting of PVDF: copolymers of PVDF swith trifuoroethylene (TrP), tetaflvonsethylene (TEE), PVDF carbon nanotube composites, PVDF nanoclay com posites, lead-zirconiumettanate ceramic. 15, The stent of claim 1, comprising a voltage controler ‘controlling application of voltage. 16. A method of producing an anticoagulant effect andor ‘an antiadhesive effect in a patieal, comprising a step of ‘implanting in the patient a stent comprising @ negative- ‘charge-producing surface 17. The mithod of claim 16, wherein the stent comprises @ piezo-electric material 18, The method of claim 16, whereia the implanting step ‘comprises implanting a drug-eluting stent 19, The method of claim 16, wherein the implanting step ‘comprises implanting stent selected from the group consist- Ing of a cardi stent; coronary artery stent;a Vascularstent; an away stent; gastrointestinal stent; and a urologic stent. 20, The method of claim 16, wherein the implanting step ‘comprises implanting a smart stent, 21. The method ofelaim 16, wherein thestent comprises at least one selected from the group consisting of PVDF: ‘copolymers of PVDF with tnfluoroetiylene (TPE), tet rafluoroethylene (TPE), PVDF earbon nanotube composites PVDF nanoclay composites, and. lead-rirconium-ttanate 22, A smart stent system, comprising: (a) a smart stent implantable into living patient, comprising a piezo-electric ‘material and producing a recordable signal and (b) a signal receiver physically separate from the smart stent and receiv jing the recordable signal fm the smart stent ata distance ia range ofabout 1 0 2 or more feet. rising a piezo-electric mate- Feb. 5, 2009 23. The smart stent system of claim 21, wherein the receiver is wireless and is couple either directly or wirelessly ‘oa file, an amplifier and « monitor 24. The smart stent system of claim 22, where inthe moni {oris selected from the group consisting of computer and a person al digital assistant device 2S. The smar stent system of claim 22, wherein the smart stent comprises at leat one passive component selocte! rom the group consisting of: a diode bridge to control voltage ‘swings and a voltage regulator. 26. The sman stont system of claim 22, wherein the smart stentcomprisesahigh density rechargeable battery, fiteran Amplifier and an A/D converter (microcontroller) 27. The smart stent system of claim 22, wherein an elee- ‘rial output ofthe piezoclecric material charges the battery andor powers at least one compontcat of the ste 28. The smart stent system of claim 22, comprising a recordable voltage output sent by the stent, wherein the recordable voltage outputs proportional tat least one fune- tion oe propesty of tissue where the steal is situate 29. The smart stent system of claim 22, wherein the stent comprises atleast one piezo-electric material, andthe system comprises @ recordable voltage output from interaction between the piezo-electric material and a material in contact with the piezo-electric material 30, The smart stent system of claim 22, wherein the stents sol-powered. 31, The smart stent system of elaim 22, comprising within the stent at least one substance releasable from the stent, {lrther comprising a releasing mechanism for releasing the stibstance wherein the releasing mechanism is powered by interaction ofa pieapeecteic material with a issue in whieh the stent is situated, 32. The smart stent system of claim 22, comprising a stent selected fom the group consisting of: & negative-charge- producing stent; an anticoayulant stent; an aniadhesive tet; 8 positive change producing stent a positive-charge-prodne- ing stent; procoagulant stent; andl a proadhesive stat A sont comprising:a piezo-electric material, the stent being sel-powercd without neding a separste power source ‘whe the stent is implanted in living patient, 34. The stent of claim 33, wherein the stent interferes with “undesirable clotting in a patient in which the stent has boon ‘implanted. 38. The stent of claim 33, comprising a signal-seader ‘whieh sends an electronic signal to a location external rom ‘the stent, the signal comprising cloting elated information 36. The stent of elaim 33, comprising a recordable voltage ‘output, wherein the recordable voltage output is proportional {oat least one funetion or property ofa issue where the tent is situated. 37. The stent of claim 38, comprising atleast one piezo clectric material and a recordable voltage outpt fom inter= action between the piezo-electric material and a material in jeontaet with the piezo-oletric material. 38, The stent of claim 33, further comprising at least one substance releasable from the stent, and releasing mecha- ism for releasing the substance wherein the releasing ‘mechanism is powered by interaction of piezoelectricmate- ‘al with a tissue ia which the stent is situated, 39, Thestent of claim 38, comprising a stent selected from the group consisting of a negaive-charge-producing stot Anticoagulant steal; an antiadhesive sent; a postive: US 2009/0036975 AI ‘charge producing stent: postive-charze-produei procoagulant stent; and 2 proadhesive stent 40. A method of constreting a smart stents prising the steps of (a) forming a implantable selE- powered sent stricture comprising at east one piezo-electric material, ‘and implantable ito a patient, the stent structure formed 10 produce signal comprising a recordable voltage output pro- portional tat least one function orpoperty ofa tissue where the stent is tobe situated: (b) constructing a receiving device that receives the recordable voltage output produced by the sent structure wherein the receiving device may be separate Jom the implantable stent structure, “Themethod of elaim 40, further comprising: formingin the steal reservoir for holding a releasable phamaaceutical ‘or other substance and having a release mechanism powered by power generated by the piezo-lecitic material which power may he used directly or stored or converted before being used to power the release mechanism, 42 The meted of elim 40, comprising: arranging orien- tation of the atleast ane piezo-elecitie material produce @ ‘certain negative charge of positive charge, 48.4 drug delivery system, comprising: a container com- prising at easton piezo-electrie materia, theeontainercom- prising a cavity forholdingan amount of drugto be released Into. patient, wherein the containers implantable ina living patient. 4. The drug delivery system of claim 43, comprising 3 ‘dru. 45. The drug delivery system of claim 43, further compris ‘ng an electronic signal that is based on an interaction ofthe piszo-eleetronie material with a tissue ofthe patient and that ‘s outhound 1 a remote device 46, The drug delivery system of claim 43, comprising «| remote control system by which a physician may remotely ‘contol atleast one parameter relating to release ofthe drug ‘contained in the container. 47, The drug delivery system of claim 46, wherein the paranete contolled is selected from the group consisting of ‘umber of apertures through which the drug may release; size ‘of apertures through which the drug is released; shape of fpertures through which the dg releases, 48. A method of myocardial monitoring, pulmonary artery monitoring. carotid artery monitoring, of cerebral artery ‘monitoring in a patient, comprising: (8) implanting in the patient stent, (b) receiving from the stent electronic signals. Feb. 5, 2009 49, The method of claim 48, where the receiving step comprises receiving from thestent electronic signal relevant {o one selected from the group consisting of myocardial {unction, myocardial pressure, myocardial temperature, pul- monary artery funetion, pulmonary aetery pressure, pollio- ry artery flow, pulmonary artery lemperature, carotid artery funetion, carotid artery pressure, carotid artery How, cerebral artery function, cerebral artery pressure cerebral ariery Now And cerebral artery temperature in the patient. $0, The method of claim 49, wherein the stent comprises at least one piezo-electric material ‘3, The method of claim 49, wherein the stent is self: powered '2.

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