WO2005049103A2 - Implantable heart valve prosthetic devices having intrinsically conductive polymers - Google Patents
Implantable heart valve prosthetic devices having intrinsically conductive polymers Download PDFInfo
- Publication number
- WO2005049103A2 WO2005049103A2 PCT/US2004/038587 US2004038587W WO2005049103A2 WO 2005049103 A2 WO2005049103 A2 WO 2005049103A2 US 2004038587 W US2004038587 W US 2004038587W WO 2005049103 A2 WO2005049103 A2 WO 2005049103A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- intrinsically conductive
- heart valve
- fabric
- polymer
- conductive polymer
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2403—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with pivoting rigid closure members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
Definitions
- the present invention is related generally to biomedical devices. More specifically, the present invention is related to conductive polymer surfaces on implantable cardiac valve prostheses. The present invention can be used to advantage in heart valve annuloplasty rings, annuloplasty bands, and sewing rings.
- Heart valve sewing prostheses are suturable prosthetic devices that can be implanted in hearts to support or replace the function of the native heart valve.
- One heart valve sewing prosthesis is an annuloplasty ring.
- An annuloplasty ring is a ring or annular shaped device including a round outer surface having an outer diameter approximating the desired inner diameter of the tissue near the valve where the ring is to be implanted.
- the ring generally has an inner stiffening member, which can be formed of silicone.
- the ring outer surface can be formed of a fabric, such as knitted or braided polyester, for example Dacron ®.
- the annuloplasty ring can be inserted into place and sewn to the surrounding valve aimulus tissue using sutures passing through the fabric and through the tissue.
- annuloplasty band is similar in some respects to an annuloplasty ring.
- the annuloplasty band can have an arcuate or circular shape, and an open circumferential gap along one side, rather than being closed upon itself as is an annuloplasty ring.
- the annuloplasty band can be formed of an inner stiffening member surrounded by fabric. The outer fabric can receive sutures through the fabric, securing it to the surrounding tissue.
- Annuloplasty rings and bands can be used in conjunction with valvular reconstructive surgery, to correct heart valve defects such as stenosis or valvular insufficiency. Many such defects are associated with dilation of the valve annulus. Such dilation can prevent competence of the valve and can cause distortion of the normal shape of the valve orifice.
- Annuloplasty rings generally entirely encompass the anterior and posterior portions of the valve annulus, while the annuloplasty bands generally encompass only a portion of the valve annulus.
- Other heart valve prostheses include prosthetic heart valves, such as mechanical prosthetic heart valves and bioprosthetic heart valves.
- Mechanical heart valves can include a metal housing containing a metal valve plate that open and closes about a pivot.
- the bioprosthetic heart valve can be made from porcine heart valves that have been fixed to reduce adverse reactions upon implant.
- the tissue or housing can be secured to the surrounding tissue using another heart valve prosthetic device, a sewing ring or cuff.
- the sewing ring or cuff generally includes a ring or cuff having an outer fabric layer. The sewing ring or cuff can come secured to the heart valve outer housing.
- the sewing ring acts as an intermediate body placed between the heart valve outer housing and the native heart tissue.
- the heart valve housing can be secured to the native tissue by passing sutures through the sewing ring or cuff and the surrounding tissue.
- Materials used to fabricate heart valve sewing prostheses typically include polyester fabric.
- the host responds to this material as a "foreign body” and this reaction complicates the healing process.
- An ideal prosthetic valve device should heal well without excessive tissue overgrowth, and allow for the establishment of a smooth neointima. By reducing the inflammatory response to the foreign material, it may be possible to resolve the post-implant inflammatory response at the acute phase, with concomitant optimal healing without the long-term scar formation and consequences of stenosis and regurgitation.
- non-biologic materials in prosthetic heart valves such as sewing rings and stents in tissue valves are necessary to support the tissue components and facilitate attachment of valves to the native tissue.
- the implantation of these non-resorbable materials permanently changes the microenvironment of the valve tissue, and possibly the global environment of the cardiac system.
- Peri-operative implant protocols may require the removal of the native valve leaflet, and cutting away damaged and/or mineralized tissue. These operations cause a major trauma to the tissue.
- the tissue response to this traumatic injury involves inflammatory response to the initial wound bed created for the prosthetic valve, and to the implanted non-native material.
- the inflammatory response may be divided into the acute and chronic phases. Unresolved acute inflammatory response leads to a chronic phase response with potential fibrotic tissue formation.
- pannus I Along with the chronic fibrotic scar formation, inflammatory cells and the accumulation of cellular and proteinaceous blood elements are deposited. The layer of deposited cells and other elements is often referred to a pannus.
- the pannus grows as an extension of the tissue healing around the sewing ring or other heart valve sewing prosthesis. As a result of the unresolved inflammatory response, the pannus can continue to grow, extending onto the leaflets causing progressive stenosis, occlusion of the valve orifice or stiffening of the cusps. It has been shown that pannus can creep onto the biologic part of the valve and causes stenosis andor incompetence.
- Tissue overgrowth has also been shown to cause leaflet retraction in valves, leading to clinically significant regurgitation. Tissue overgrowth onto mechanical valves can obstruct the occluder causing failure of the valve. Pannus overgrowth on both tissue and mechanical valves may necessitate their removal. As a result of the exuberant pannus growth onto the sewing ring of the valves, removal becomes difficult, making subsequent operations even more challenging. There is therefore the need for superior biomaterials that will promote post-implant wound healing with limited scar formation. In particular, there is a need for heart valve sewing rings, annuloplasty rings, and annuloplasty bands having improved biocompatibility characteristics.
- the present invention provides implantable heart valve sewing prostheses having an improved, more biocompatible surface including an intrinsically conductive polymer.
- the heart valve sewing prostheses include annuloplasty prostheses and prosthetic heart valves sewing prostheses.
- the annuloplasty prostheses include annuloplasty rings, which are substantially closed upon themselves, and annuloplasty bands, which have an arcuate shape and have an annular gap.
- the prosthetic heart valve sewing prostheses include sewing rings and swing cuffs on both mechanical and bioprosthetic heart valves.
- the surface can include a fabric portion incorporating an intrinsically conductive polymer.
- the surface is a blood contacting external surface having an intrinsically conductive polymer layer, where the device is selected from the group consisting of heart valve annuloplasty rings, heart valve annuloplasty bands, mechanical prosthetic heart valves, and bioprosthetic heart valves.
- the external surface includes a fabric having the polymer layer formed over the fabric.
- the fabric can be formed of a plurality of individual filaments, in which the polymer layer is at least in part formed by a polymer coating over the individual filaments.
- the fabric can also be formed of a plurality of individual filament bundles formed of a plurality of filaments, in which the polymer layer is at least in part formed by a polymer coating over the individual filament bundles.
- the fabric can be formed of a plurality of individual fibers formed of a plurality of filament bundles formed of a plurality of filaments, in which the polymer layer is at least in part formed by a polymer coating over the individual fibers.
- the polymer layer is a product of in situ polymerization on the fabric.
- the fabric is formed at least in part of filaments of integrally formed, intrinsically conductive polymer.
- the polymer layer includes polypyrrole or derivatives thereof
- the polymer layer includes a polymer selected from the group consisting of polyaniline, polypyrrole, poly(vinylferrocene), polyactelyne, polythiophene, polybithiophene, and derivatives thereof.
- the polymer can be doped with dialkyl-napthalene sulfonate. While the present application presents a limited number of intrinsically conductive polymers and dopants, many other intrinsically conductive polymers have been and will be developed, and are also within the scope of the invention.
- the polymer layer has a surface resistivity between about 10 and 1000 ohms per square in some embodiments, and a surface resistivity less than 2000 and 1000 ohms per square in two other embodiments.
- the present invention also provides a prosthetic heart valve for implanting in a patient, the heart valve including an annular housing having a flow channel therethrough for the passage of blood, an inside surface forming the flow channel for blood, and an outside surface for facing heart tissue.
- the prosthetic heart valve can also include a valve flow control member moveably secured to the housing and having an open position and a closed position, and a ring shaped body disposed about the annular housing outside surface, where the ring shaped body has external surface including an intrinsically conductive polymer.
- the flow control member can include a leaflet pivotally coupled to the housing.
- the ring shaped body external surface can have the intrinsically conductive polymer present as a coating over at least part of the external surface.
- the device external surface can include fabric, where the fabric includes the intrinsically conductive polymer.
- the polymer forms a layer over the fabric surface in some embodiments.
- the intrinsically conductive polymer can be deposited on a fabric using in-situ polymerization of monomeric or oligomeric species, together with a dopant. Animal studies were performed using polyester annuloplasty rings having a conventional, uncoated half, and a half coated with intrinsically conductive polymer. The coated half demonstrated a substantial reduction in pannus formation and inflammatory response compared to the uncoated half.
- Figures 1A, IB, 1C, and ID are chemical structure diagrams of four types of intrinsically conductive polymers;
- Figure 2 is a cutaway perspective view of an annuloplasty ring having an outer sheath incorporating an intrinsically conductive polymer;
- Figure 3 is a cutaway top view of an annuloplasty band having an outer sheath incorporating an intrinsically conductive polymer;
- Figure 4 is a perspective view of a mechanical heart valve having an outer sewing ring;
- Figure 5 is a perspective view of a stented bioprosthetic heart valve having an outer sewing ring;
- Figure 6 is a diagrammatic top view of a composite annuloplasty ring and associated explanted tissue, used in experiments of the present invention, having an uncoated Dacron left side and a right side coated with an intrinsically conductive polymer;
- Figure 7 A is a photograph of an atrial (top) view of the ring of Figure 6 and associated tissue after removal from a sheep, where the composite ring included a Dacron cloth half coated with polypyrrole
- Figure 10 is a photomicrograph of tissue taken from the polypyrrole coated Dacron doped with dialkyl-napthalene-sulfonate, stained for Von Willibrand factor showing a thin endothelial lining on the tissue surface.
- the present invention provides improved heart valve sewing prostheses, including annuloplasty bands, annuloplasty rings, and prosthetic heart valve sewing rings or cuffs.
- These improved devices can all incorporate a fabric portion including an intrinsically conductive polymer.
- the fabric portion can be sutured to a heart valve annulus, providing a more biocompatible surface for these devices.
- annuloplasty prosthesis means annuloplasty rings and annuloplasty bands
- hetero valve sewing prosthesis means annuloplasty rings, annuloplasty bands, and prosthetic heart valve sewing rings and prosthetic heart valve sewing cuffs.
- Intrinsically Conductive Polymers One class of new materials is intrinsically conductive polymers. The progenitors of chemistry did not foresee organic intrinsically conducting or electroactive polymers as a fiiture technological possibility. As used here, "intrinsically conductive polymers" refers to polymers that are conductive without requiring non-polymeric conductive fillers or coatings, such as metallic filler or coatings or carbon fillings or coatings. Intrinsically conductive polymers do often include dopants to facilitate their conductivity.
- intrinsically conductive polymers can generally range from semi- to superconducting, depending on the doping levels Until recently, the subject of intrinsically conductive polymers was a "chemical apostasy."
- Intrinsically conductive polymers are part of a large class of materials called synthetic metals. Examples of intrinsically conductive polymers include polyaniline, polypyrrole, poly (vinylferrocene) polyacetylene, polythiophene, and polybithiophene. This is by no means an exhaustive list of all known intrinsically conductive polymers, as new intrinsically conductive polymers/copolymers continue to be synthesized by various investigators.
- intrinsically conductive polymers fall into three broad categories: (1) ⁇ -conjugated electronically conducting polymers as shown in Figures 1 A and IB; (2) polymers with covalently linked redox groups, as shown in Fig 1C; and 3) ion-exchange polymers, as shown in Fig ID, in which the counter ion is electroactive.
- the intrinsically conductive polymers illustrated in Figures 1 A-1D are examples, and do not necessarily limit the present invention. Derivatives of the examples in Figures 1A-1D can also be used in the present invention.
- polypyrrole can be substituted at the 2 or 5 position, for example with alkyl or aryl groups or combinations thereof.
- the ⁇ -conjugated polymers e.g.
- doped polyacetylene and polypyrrole have delocalized electronic states and are electronically conducting.
- the conductive states are made by either oxidative or reductive chemical "doping" of the non-conducting form with a variety of chemical reagents, or by electrochemical doping.
- Chemical doping of polyacetylene (PAC) may be achieved by using iodine vapor for oxidative doping, or sodium naphthalide in tetrahydrofuran (THF), for reductive doping.
- Reac ons 3 an represent the coup e e ectron ion transfer process.
- Electroneutrality [(CH y" )]x + (xy)M + [M y + (CH y" )] x (6)
- the dopant supplies or removes electrons and the resulting ion serves as the counter ion.
- the electrode supplies or removes the electron and ions present in the electrolyte serve as counter ions.
- Redox polymers represent an important class of conductive polymers, which have been used to coat electrodes for a variety of electrochemical applications. These types of polymers are localized state conductors and are less highly conducting than the ⁇ - conjugated materials.
- Polyvinylferrocene is a redox polymer possessing an electroactive ferocenyl group, and displays a rapid heterogenous electron transfer rate.
- Redox polymers conduct current by electron self-exchange reactions (hopping) between neighboring redox sites.
- Electronically conducting polymers conduct current via charge storage species formed upon doping, such as polarons, as in polypyrrole or solitons, as in polyacetylene, through the conducting conjugated backbone.
- Intra chain charge conduction is a more efficient process than interchain conduction. The magnitude of the charge transfer would be greatly increased if both inter chain and intra chain charge conductions were accelerated by the presence of electron hopping and polaron or soliton conduction.
- Textile-reinforced materials play a crucial role in many engineering materials including polymers, ceramics, and metals.
- the importance and need for flexible conducting polymers/conducting polymer coated fabrics increased with the advent of the electrical and electronic industries.
- One of the cost-effective ways for producing conductive plastics is the incorporation of carbon (up to 40%). This amount of carbon to allow percolation causes a significant deterioration of mechanical properties in the polymer/filled blend leading to processing problems in the production of conductive textile fibers.
- Commercial products based on nylon and polyester have been developed using highly filled polymers, either in the core or as a sheath of the fiber, that retain at least some of the strength of the unfilled polymer.
- Conductive textiles, with coatings of metals have also been produced.
- a variety of methods used to coat textiles include vapor deposition, sputtering, reduction of complexed copper salts, and electroless plating using noble catalysts.
- Conductive copper sulfide deposited synthetic fibers are widely used in static dissipating carpets.
- Intrinsically conductive polymers or electroactive conducting polymers offer an alternative to coating or filled plastics and textiles. The average room temperature synthesized conducting polymers, however have processing limitations; they are brittle and expensive. However, solution-spun fibers and films of polyanniline and poly(3- alkylthiophene) have been prepared. Thin films of many conjugated polymers can be produced electrochemically.
- Textiles of various kinds are reasonable choice as substrates for thin coatings of conducting polymers.
- Conductive textiles composites based on polypyrrole or polyanniline result in structures showing surface resistances of 10 - 1000 ohms/square ( ⁇ /sq).
- Conducting polymer textile composites have excellent adhesion and do not corrode.
- Chemical polymerization of conducting polymers from aqueous solution leads to the formation of films on the liquid air or liquid/solid interface. This spontaneous molecular assembly has been used to polymerize conducting polymers on the surface of numerous materials, including membranes, and has been successfully applied to textiles.
- Polymerization of polypyrrole and polyaniline occur by the formation of radical cations that couple to form oligomers, which are further oxidized to form additional radical cations.
- the polymerization of pyrrole and aniline proceeds through one of these oligomeric intermediates, as neither the monomer nor the oxidizing agent adsorbs to the fabric.
- Conventional fabric such as Dacron or polyester can be coated with an intrinsically conductive polymer to make the coated fabrics used in the present invention.
- a solution can be prepared having the monomers or pre-polymers together with the dopant.
- the monomers or pre-polymers can be polymerized in-situ on the cloth surface, fonning an intrinsically conductive polymer layer.
- Such coating processes are well known and need not be described in detail here. Such processes are described in: Kuhn HH, Polypyrrole coated textiles, properties and applications, Sen-I Gakkai Symp. Prepr.
- the present invention provides this application of intrinsically conductive polymers to facilitate optimal post implant wound healing.
- Applicants obtained the intrinsically conductive polymer coated cloth used in the present invention from Milliken Research (Spartanburg, SC), the assignee of U.S. Patent No. 4,975,317, previously incorporated by reference.
- Medical grade cloth products can also be coated on demand by third party service providers, for example, by Eeonyx Corporation (Pinole California).
- Applicants believe that fabrics coated with intrinsically conductive polymers are non inflammatory and are well suited for use as components of heart valve sewing prostheses. Their charge density, and biocompatibility can be controlled with ease.
- the physical, electrochemical and chemomechanical properties of intrinsically conductive polymers make them attractive alternative biomaterials.
- Prosthetic Heart Valve Devices Figure 2 illustrates part of an annuloplasty ring 20 having an outer sheath 22 I disposed over an inner stiffening member 24.
- the inner stiffening member for the rings and bands can be made from metallic materials, such as stainless steel, Nitinol, MP35N alloy, Elgiloy TM Co-Cr-Ni alloy, or other appropriate metals currently used in making annuloplasty rings.
- Some rings have the stiffening member made of a polymeric material, for example, Silicone.
- Some rings have an inner metallic stiffening member covered by a polymeric layer, which is in turn covered by an outer fabric sheath.
- the outer sheath is preferably made of a fabric, which can be a polyester, such' as Dacron.
- the sheaths for the rings and bands, and for the other sewing ring or cuff fabrics disclosed in the present application are formed of a knitted fabric in one embodiment, but can be a woven, non- woven, or braided fabric.
- Outer sheath 22 incorporates an intrinsically conductive polymer.
- the intrinsically conductive polymer can be integrally formed into the fabric filaments in some embodiments.
- the intrinsically conductive polymer is coated onto a more conventional fabric, such as polyester. This coating can be formed on the fabric filaments, fibers, bundles, or on the finished fabric as a whole.
- the intrinsically conductive polymer is polymerized in situ on the fabric surface.
- FIG. 3 illustrates an annuloplasty band 30 including an inner stiffening member 32, an intermediate polymeric sheath 34, and an outer fabric sheath 36.
- Annuloplasty band 30 includes an eyelet 33 for receiving a suture and suture markers 38 for marking the position of covered eyelet 33.
- Outer sheath 36 is preferably a fabric sheath incorporating an intrinsically conductive polymer, as previously described with respect to the annuloplasty ring of Figure 2.
- Figure 4 illustrates a mechanical prosthetic heart valve 40 including a housing indicated at 42 having an outer surface 52 and an inner surface 50. Inner surface 50 defines a flow lumen 44 within, where lumen 44 contains pivotally mounted leaflets 46 and 48.
- An outer sewing ring or cuff 54 including intrinsically conductive polymer is disposed about housing 42. Sewing ring 54 can be used to receive sutures to secure heart valve 40 to the surrounding heart tissue.
- Mechanical heart valves and sewing rings are well known, and are further described in U.S. Patent Nos. 5,766,240 and 6,139,575, herein incorporated by reference.
- FIG. 5 illustrates a stented bioprosthetic heart valve 60.
- Heart valve 60 includes a stent 61, biological tissue leaflets 64 meeting along commisures 62, and a sewing cuff 68.
- Sewing cuff 68 can be used to secure valve 60 to surrounding heart tissue.
- Sewing cuff 68 incorporates intrinsically conductive polymer, as previously described with respect to the annuloplasty ring of Figure 2.
- Bioprosthetic heart valves are well known, and are further described in U.S. Patent No. 6,350,282, herein incorporated by reference.
- Figure 6 illustrates an explanted composite annuloplasty ring 80 used in experiments testing some embodiments of the present invention, including polyester formed over an inner stiffening member, being coated on one half and uncoated on the other half.
- Ring 80 was used to compare the uncoated fabric with the fabric coated with intrinsically conductive polymer.
- Explanted ring 80 includes both an annuloplasty ring 82 and the surrounding tissue 84 removed with the ring.
- a first suture marker 86 marks the anterior position while a second suture marker 88 marks the dorsal position.
- the (black) right hand half 100 of ring 82 was coated with intrinsically conductive polymer while the (white) left hand half 102 of ring 82 was uncoated fabric.
- the two ring halves meet at a 12 O' Clock, anterior position indicated at 96 and at a 6 O'clock posterior position indicated at 98. Samples were taken at various positions about the ring.
- a first histology sample was taken at position 104 while a second histology sample was taken at position 110, both from the coated side.
- histology samples were taken at positions 118 and 112.
- Samples for immunohistochemistry were also taken from the coated side at position 106, from the uncoated side at position 116, and snap frozen in liquid nitrogen.
- Samples for electron microscopy were taken from the coated side at position 108 and from the uncoated side at 114. The results from the experimental data obtained from explanted ring 80 are described elsewhere in the present application.
- ETO Sterilization of Polypyrrole Coated Fabric Applicants conducted a study to determine if ethylene oxide (ETO) sterilization changes the surface morphology of polypyrrole-coated fabrics.
- Conducting polymers are stable in air, and have been used in various applications including: gaskets, microwave shielding, radar decoys, resistive and microwave heating. Applicants believed that the inherent stability of conducting polymers under various stringent environmental conditions, would allow sterilization via the ETO protocol.
- Contex ® conductive textiles developed by Milliken Research Corporation (Spartanburg, SC), were used in this study. The fabrics were cut into 1 cm 2 pieces, ETO sterilized and then subjected to Scanning Electron Microscope (SEM) analysis.
- SEM Scanning Electron Microscope
- the SEM photomicrographs showed that the ETO process does not alter the surface profiles of the polypyrrole-coated fabrics when compared to non-ETO controls. This suggests that ETO sterilization has no deleterious effects on the surface profiles of conducting polymer- coated fabrics.
- Various conducting polymer coated fabrics were also obtained from Milliken Research, Spartanburg, SC.
- the fabric samples of various conductivities include: (a) woven polyester (630 and 100 ohms/square); (b) nylon impression fabric (425 ohms/square); (c) textured knitted pet fabric (500 ohms/square); (d) textured woven polyester (30 ohm/square); and (e) glass fabric (50 ohm/square).
- the fabrics were cut into 1cm pieces, ETO sterilized before SEM analysis. Samples were numbered 1-12 for each fabric treatment as shown in a-e above, and included ETO and non-ETO controls. They were then placed onto stubs with silver paste. The samples were dried overnight in an oven at 37 °C. After drying the samples, they were coated with gold for 2 minutes and viewed under the microscope. Representative photos were taken at 30x and 500x magnifications. The studies were performed to investigate the effects of ethylene oxide sterilization on coated electroactive conducting polypyrrole. Polypyrrole was coated on various fabric materials including glass fabric, textured woven polyester, textured knitted PET fabric, and nylon impression fabric.
- the SEM micrographs at high magnification indicated that only a minimum amount of ethylene oxide is adsorbed on the fabric. It has been shown that surface resistance of polypyrrole coated textiles can be controlled by altering the concentration of chemicals that are added to the polymerization bath. The resistance of the film, however, does not change linearly with the polymer addon. The morphology of the polypyrrole film is highly dependent on it composition. The oxidation of pyrrole in aqueous solutions yields an oxidized polypyrrole with a degree of doping of 0.25-0.33; therefore, every third or fourth repeat unit has a positive charge neutralized with a counterion.
- Films prepared with the addition of hydrophobic doping agents form denser, more conducting, and stable films.
- the type of doping agent can have a considerable effect on the conductance and morphology of polypyrrole.
- Hydrophobic dopants that have been well studied include anthraquinone-2-sulfonic acid, 2-naphthalenesulfonic acid, and trichlorbenesulfonic acid.
- textile substrates represents a convenient method of introducing mechanical strength, flexibility, and processibility to conducting polymers for practical applications. Fabrics coated with a thin layer of polypyrrole have the same mechanical properties as the textile substrate.
- rhodacal BX dialkyl-naphthalene-sulfonate, 670 ohm/sq, abbreviated hereinafter as RBX-670
- AQSA-850 anthraquinone-2-sulfonic acid
- AQSA-5000 anthraquinone-2-sulfonic acid
- a left thoracotomy was performed through the fourth intercostal space.
- the pericardial cavity was opened vertically, anterior to the left phrenic nerve.
- a purse string was placed in the right atrial appendage.
- Heparin was given via IN. (3.5 mg/Kg) and the aortic arch was cannulated with a #20 F cannula for atrial return.
- the right atrium was cannulated through the right appendage, with #32-40 F two-stage venous cannula.
- Cardiopulmonary bypass was established and normothermic perfusion was maintained.
- the left ventricle was vented through the apex with an 18 F angled venous cannula.
- the ascending aorta was dissected up to its bifurcation and the pulmonary trunk was taped.
- a pledgeted 4/0 prolene "TJ" suture was placed in the ascending aorta for delivery of cardioplegia.
- the aorta was cross-clamped and 800 cc of cold crystalloid cardioplegia was infused under pressure delivered by a blood transfusion bag.
- Sterile ice slush was placed in the pericardial cavity.
- An oblique left atriotomy was performed starting at the roof of the atrium and continued through the left appendage to the AV groove allowing excellent exposure of the mitral valve.
- Annuloplasty Ring A 2/0 Ethibond suture was passed through each of the trigones and the intertrigonal distance was measured with the Duran Ring Obturator and recorded. Three 2/0 Ethibond sutures were passed along the intertrigonal space, through the entire thickness of the aortic curtain. Sutures were then placed at the commissures and parallel to the annulus along the base of the posterior leaflet. Sutures were then passed through the ring and the trigonal sutures are passed through the corresponding ring markers. After that, the ring was brought down into position. All the stitches were then tied securely.
- the rings (see Figure 6) were composite: one half of the ring was uncoated (i.e.
- a standard Duran ring and the other half was coated with one of three different treatments (AQSA-850, RBX-670 or AQSA-5000).
- the coated half of the ring did not have the standard silastic band.
- Suture markers were used to identify each half. Ring size was 27 mm.
- the rings were oriented perpendicular to the mitral orifice, i.e. each half of the ring sat across the intertrigonal space. The ring position was evaluated and coaptation of the leaflets was checked with saline.
- the left atriotomy was closed with a continuous running 4/0 prolene suture.
- the cardiopulmonary bypass re-warmed the body temperature up to 38°C.
- the aorta was undamped and the heart de-aired by luxation and suction through the left vent and the aortic orifice for cardioplegia.
- DC shock was applied to defibrillate the heart.
- the lungs were expanded and the left vent was removed.
- the animal was weaned from CPB and the contents of the oxygenator transfused through the arterial cannulae.
- the venous and arterial cannulae were removed and protamine was administered at a ratio of 1.5 to 1 of heparin.
- Epicardial echocardiography was performed to evaluate the mitral valve mobility and the absence of regurgitation. Hydrostatic pressure measurements were taken from the left atrium and left ventricle in order to measure the transvalvular gradient.
- the mitral valve was excised and the left atrial (LA) and left ventrical (LV) aspects were photographed.
- the photographs of the LA and LV views of the mitral valve with the ring exposed were used to score the degree of pannus formation on the ring.
- the amount of pannus was graded on a scale of 0-4+.
- the coated side was compared to the uncoated side of the ring. If the amount of pannus was no greater on the coated side of the ring vs. the uncoated side, the score was 0.
- a portion of the tissue from both the coated and uncoated sides of the explanted sample was snap frozen in liquid nitrogen and stored at -80° C.
- Histology Samples for histology were fixed in Histo-Choice Tissue Fixative MB (Amresco Inc., Solon, Ohio, USA) for 24 hours before further processing. After 24 hours, the histology samples (2 each of both uncoated and coated sections of the ring) were removed to histology cassettes, and placed in new Histochoice. After 1 week, all samples were dehydrated and embedded in PolyFin wax (Polysciences, Inc., Warrington, Pennsylvania, USA), sectioned at 5 ⁇ m, and collected on poly-L-lysine (Sigma Chemical Co., St. Louis, Missouri, USA) coated slides. Representative sections were stained with hematoxylin and eosin (H&E) for general tissue and cellular morphology.
- H&E hematoxylin and eosin
- H&E stained sections were correlated with immunostain for Von Willebrand factor.
- a protocol for scoring the histology samples was devised and the slides were studied and compared by two observers independently. Results recorded on a worksheet were compared and discrepancies "settled” by joint observation, and comparison. Both observers were blinded to the treatment. Statistics Paired, two-tailed students t-test was used to compare the means of the various measurements of the treated and untreated sides of each ring as well as hemodynamic measurements taken at implantation and harvest.
- Sacrifice White tissue covered all areas of the mitral annulus and ring by macroscopic observation. There were no differences noted between the coated and the uncoated part of the Duran ring for treatments AQSA-5000 and AQSA-850: However, treatment RBX-670. appeared to decrease pannus formation on the coated (black) side of the ring since the black color of the coating was more visible.
- Gross Pathology Two differentially doped electroactive conducting polypyrrole were used to treat the /
- Dacron cloth used to fabricate the composite rings used to fabricate the composite rings.
- the two treatments were coded as AQSA-850 (not shown) and RBX-670 ( Figures 7A and 7B).
- Figures 7A and 7B show representative pictures taken at the time of explant and show the gross pathology around the implanted composite rings for the RBX-670 rings.
- Figure 7A shows an anterior left atrial view
- Figure 7B shows an anterior left ventricular view of explanted composite Duran annuloplasty rings (with associated tissue) implanted for 8 weeks in sheep.
- Tissue coverage for treatment RBX-670 was 2 times less than that observed for AQSA-850 and uncoated portions of the Dacron-cloth. In addition, no calcium deposits were observed.
- the ring was positioned against the heart muscle superior to (above) the native valve leaflet, between the atrium and the ventricle of the heart.
- the D position was directly against the heart muscle tissue while the C position was directly away from the tissue, directly into the blood flow.
- the A position was slightly away from the D position, but toward the ventricle and thus downstream relative to the blood flow.
- the B position was away from the D position, but toward the atrium and exposed to the blood flow. If the D (tissue contacting) position is at 6 O'clock, then the C position is at 12 O'clock, while the A position is at about 7 O'clock and the B position is at about 4 O'clock.
- the fibrotic reaction measured at points A, B, C and D surrounding the ring was not different for the uncoated side vs.
- the Y axis of Figure 8 indicates the measured cumulative capsule thickness in microns while the X axis groups the measurements from the coated half of the ring at "1.0" and those from the uncoated half of the ring at "2.0.” Each data point represents a unique measurement, taken from a different animal. Differences between the coated and uncoated ring portions can be visualized by comparing the two columns of data points for each of the locations A, B, C, and D. The cumulative thickness of fibrotic capsule for each location (A, B, C, D) on the coated (RBX-670 polypyrrole coating) and uncoated Dacron portions of the composite annuloplasty ring was plotted as shown in Figure 8.
- Positions B and C are the luminal side (blood contacting side) of the ring facing the atrium, while A and D are the tissue contacting side.
- the conductive polypyrrole was most effective in reducing the fibrose thickness on positions B and C, illustrated by the difference in height between columns 1.0 and 2.0 for B and C.
- Inflammation Score Treatment RBX-670 also appeared to reduce the level of host inflammatory response to the ring material as is shown by the mean inflammation score and the frequency distribution of the scores.
- the mean inflammation scores were very similar for the black (coated) vs. white (uncoated) sides of the ring for treatments AQSA-5000 and AQSA-850.
- the degree of inflammation was also scored based on a comparison between the ring and the suture (suture was not always present on each slide but was at least present on one out of four, 2 white and 2 black). If the relative number of inflammatory cells present was not greater around the ring than the suture the score was 0. A scale of 0 to 4+ was used.
- Figures 9A and 9B are H&E stains of sections from explanted doped (RBX-670) conducting polypyrrole coated/uncoated Dacron composite annuloplasty ring implanted in the mitral position of the heart of juvenile sheep for 8 weeks.
- Figure 9A is an H&E stain of section from uncoated Dacron portion of the composite ring, and shows extensive fibrous tissue formation.
- Figure 9B shows a 30 % reduction of pannus associated with the underlying coated Dacron. Immunohistochemistry All samples exhibited a continuous to mostly continuous layer of surface cells that were positively stained for Von Willebrand factor. This indicates an intact layer of endothelial-like cells on the surface of the fibrotic tissue surrounding the ring.
- FIG. 10 shows Von Willibrand factor stains of the thin endothelial lining of tissue associated with the electroactive-conducting polymer RBX-670 coated Dacron. The layer extends along the tissue interface, from the top-middle to the bottom-right in Figure 10.
- Figure 10 indicates that the intrinsically conductive polymer does not interfere with the endothelialization of the fabric surface.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002546322A CA2546322A1 (en) | 2003-11-17 | 2004-11-17 | Implantable heart valve prosthetic devices having intrinsically conductive polymers |
JP2006541349A JP2007511329A (en) | 2003-11-17 | 2004-11-17 | Implantable heart valve prosthesis device with intrinsically conductive polymer |
EP04811331A EP1691855A2 (en) | 2003-11-17 | 2004-11-17 | Implantable heart valve prosthetic devices having intrinsically conductive polymers |
AU2004290583A AU2004290583A1 (en) | 2003-11-17 | 2004-11-17 | Implantable heart valve prosthetic devices having intrinsically conductive polymers |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/714,767 US7740656B2 (en) | 2003-11-17 | 2003-11-17 | Implantable heart valve prosthetic devices having intrinsically conductive polymers |
US10/714,767 | 2003-11-17 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2005049103A2 true WO2005049103A2 (en) | 2005-06-02 |
WO2005049103A3 WO2005049103A3 (en) | 2005-11-17 |
Family
ID=34574053
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/038587 WO2005049103A2 (en) | 2003-11-17 | 2004-11-17 | Implantable heart valve prosthetic devices having intrinsically conductive polymers |
Country Status (6)
Country | Link |
---|---|
US (1) | US7740656B2 (en) |
EP (1) | EP1691855A2 (en) |
JP (1) | JP2007511329A (en) |
AU (1) | AU2004290583A1 (en) |
CA (1) | CA2546322A1 (en) |
WO (1) | WO2005049103A2 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8133270B2 (en) | 2007-01-08 | 2012-03-13 | California Institute Of Technology | In-situ formation of a valve |
US8343212B2 (en) | 2007-05-15 | 2013-01-01 | Biotectix, LLC | Polymer coatings on medical devices |
US8414641B2 (en) | 2007-12-21 | 2013-04-09 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
US8460365B2 (en) | 2005-09-21 | 2013-06-11 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8470023B2 (en) | 2007-02-05 | 2013-06-25 | Boston Scientific Scimed, Inc. | Percutaneous valve, system, and method |
US9028542B2 (en) | 2005-06-10 | 2015-05-12 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US9622859B2 (en) | 2005-02-01 | 2017-04-18 | Boston Scientific Scimed, Inc. | Filter system and method |
WO2017158148A1 (en) | 2016-03-17 | 2017-09-21 | Centro Cardiologico Monzino | Polymers and uses thereof in manufacturing of 'living' heart valves |
US9808341B2 (en) | 2005-02-23 | 2017-11-07 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US9861473B2 (en) | 2005-04-15 | 2018-01-09 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US9918834B2 (en) | 2004-09-02 | 2018-03-20 | Boston Scientific Scimed, Inc. | Cardiac valve, system and method |
US10869764B2 (en) | 2003-12-19 | 2020-12-22 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
Families Citing this family (86)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6602286B1 (en) | 2000-10-26 | 2003-08-05 | Ernst Peter Strecker | Implantable valve system |
JP4398244B2 (en) | 2001-10-04 | 2010-01-13 | ネオヴァスク メディカル リミテッド | Flow reduction implant |
US6752828B2 (en) | 2002-04-03 | 2004-06-22 | Scimed Life Systems, Inc. | Artificial valve |
US6945957B2 (en) | 2002-12-30 | 2005-09-20 | Scimed Life Systems, Inc. | Valve treatment catheter and methods |
IL158960A0 (en) | 2003-11-19 | 2004-05-12 | Neovasc Medical Ltd | Vascular implant |
US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
EP2308425B2 (en) | 2004-03-11 | 2023-10-18 | Percutaneous Cardiovascular Solutions Pty Limited | Percutaneous Heart Valve Prosthesis |
US7377941B2 (en) * | 2004-06-29 | 2008-05-27 | Micardia Corporation | Adjustable cardiac valve implant with selective dimensional adjustment |
US7854755B2 (en) | 2005-02-01 | 2010-12-21 | Boston Scientific Scimed, Inc. | Vascular catheter, system, and method |
US7878966B2 (en) | 2005-02-04 | 2011-02-01 | Boston Scientific Scimed, Inc. | Ventricular assist and support device |
US7670368B2 (en) | 2005-02-07 | 2010-03-02 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7780722B2 (en) | 2005-02-07 | 2010-08-24 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
AU2006315812B2 (en) | 2005-11-10 | 2013-03-28 | Cardiaq Valve Technologies, Inc. | Balloon-expandable, self-expanding, vascular prosthesis connecting stent |
US7799038B2 (en) | 2006-01-20 | 2010-09-21 | Boston Scientific Scimed, Inc. | Translumenal apparatus, system, and method |
US7806900B2 (en) | 2006-04-26 | 2010-10-05 | Illuminoss Medical, Inc. | Apparatus and methods for delivery of reinforcing materials to bone |
US20090306768A1 (en) | 2006-07-28 | 2009-12-10 | Cardiaq Valve Technologies, Inc. | Percutaneous valve prosthesis and system and method for implanting same |
US7879041B2 (en) | 2006-11-10 | 2011-02-01 | Illuminoss Medical, Inc. | Systems and methods for internal bone fixation |
WO2008063265A1 (en) | 2006-11-10 | 2008-05-29 | Illuminoss Medical, Inc. | Systems and methods for internal bone fixation |
WO2008099433A1 (en) * | 2007-02-15 | 2008-08-21 | Roberto Erminio Parravicini | Mitral annuloplasty ring |
ES2562480T3 (en) | 2007-07-03 | 2016-03-04 | Synergy Biosurgical Ag | Medical implant |
US8828079B2 (en) | 2007-07-26 | 2014-09-09 | Boston Scientific Scimed, Inc. | Circulatory valve, system and method |
EP2185105A4 (en) * | 2007-08-10 | 2011-03-09 | Micardia Corp | Adjustable annuloplasty ring and activation system |
CN101801280B (en) | 2007-09-17 | 2014-08-20 | 协同生物外科股份公司 | Medical implant |
US7899552B2 (en) * | 2007-10-15 | 2011-03-01 | Cardiac Pacemakers, Inc. | Conductive composite electrode material |
EP2205312B1 (en) * | 2007-10-19 | 2015-12-02 | Cardiac Pacemakers, Inc. | Fibrous electrode material |
US9427289B2 (en) | 2007-10-31 | 2016-08-30 | Illuminoss Medical, Inc. | Light source |
US8403968B2 (en) | 2007-12-26 | 2013-03-26 | Illuminoss Medical, Inc. | Apparatus and methods for repairing craniomaxillofacial bones using customized bone plates |
EP2901966B1 (en) | 2008-09-29 | 2016-06-29 | Edwards Lifesciences CardiAQ LLC | Heart valve |
WO2010040009A1 (en) | 2008-10-01 | 2010-04-08 | Cardiaq Valve Technologies, Inc. | Delivery system for vascular implant |
US8107153B2 (en) * | 2009-03-31 | 2012-01-31 | The University Of Connecticut | Flexible electrochromic devices, electrodes therefor, and methods of manufacture |
CA2757837A1 (en) * | 2009-04-07 | 2010-10-14 | Illuminoss Medical, Inc. | Photodynamic bone stabilization systems and methods for treating spine conditions |
US8414644B2 (en) | 2009-04-15 | 2013-04-09 | Cardiaq Valve Technologies, Inc. | Vascular implant and delivery system |
BR112012003783A2 (en) * | 2009-08-19 | 2016-04-19 | Illuminoss Medical Inc | devices and methods for bone alignment, stabilization and distraction |
US8182542B2 (en) * | 2009-09-01 | 2012-05-22 | Howmedica Osteonics Corp. | Soft tissue attachment mechanism |
US9730790B2 (en) | 2009-09-29 | 2017-08-15 | Edwards Lifesciences Cardiaq Llc | Replacement valve and method |
CN102639073B (en) | 2009-11-30 | 2015-07-08 | 斯恩蒂斯有限公司 | Expandable implant |
US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
EP4018966A1 (en) | 2010-06-21 | 2022-06-29 | Edwards Lifesciences CardiAQ LLC | Replacement heart valve |
CN101851418B (en) * | 2010-06-25 | 2012-07-04 | 武汉工程大学 | Preparation method of alkyl naphthalene sulfonic acid doped with polyaniline |
WO2012012660A2 (en) * | 2010-07-21 | 2012-01-26 | Accola Kevin D | Prosthetic heart valves and devices, systems, and methods for deploying prosthetic heart valves |
EP3459500B1 (en) | 2010-09-23 | 2020-09-16 | Edwards Lifesciences CardiAQ LLC | Replacement heart valves and delivery devices |
WO2012088432A1 (en) | 2010-12-22 | 2012-06-28 | Illuminoss Medical, Inc. | Systems and methods for treating conditions and diseases of the spine |
EP2681621A4 (en) | 2011-03-02 | 2015-01-21 | Univ Connecticut | Stretchable devices and methods of manufacture and use thereof |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US8936644B2 (en) | 2011-07-19 | 2015-01-20 | Illuminoss Medical, Inc. | Systems and methods for joint stabilization |
US9144442B2 (en) | 2011-07-19 | 2015-09-29 | Illuminoss Medical, Inc. | Photodynamic articular joint implants and methods of use |
US9668859B2 (en) | 2011-08-05 | 2017-06-06 | California Institute Of Technology | Percutaneous heart valve delivery systems |
CA3051684C (en) | 2011-12-06 | 2020-06-16 | Aortic Innovations Llc | Device for endovascular aortic repair and method of using the same |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US8939977B2 (en) | 2012-07-10 | 2015-01-27 | Illuminoss Medical, Inc. | Systems and methods for separating bone fixation devices from introducer |
US9687281B2 (en) | 2012-12-20 | 2017-06-27 | Illuminoss Medical, Inc. | Distal tip for bone fixation devices |
US10583002B2 (en) | 2013-03-11 | 2020-03-10 | Neovasc Tiara Inc. | Prosthetic valve with anti-pivoting mechanism |
US9730791B2 (en) | 2013-03-14 | 2017-08-15 | Edwards Lifesciences Cardiaq Llc | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
US9681951B2 (en) | 2013-03-14 | 2017-06-20 | Edwards Lifesciences Cardiaq Llc | Prosthesis with outer skirt and anchors |
US20140277427A1 (en) | 2013-03-14 | 2014-09-18 | Cardiaq Valve Technologies, Inc. | Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery |
US9744037B2 (en) | 2013-03-15 | 2017-08-29 | California Institute Of Technology | Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
EP3017107B1 (en) | 2013-07-02 | 2023-11-29 | The University of Connecticut | Electrically conductive synthetic fiber and fibrous substrate, method of making, and use thereof |
CA2938614C (en) | 2014-02-21 | 2024-01-23 | Edwards Lifesciences Cardiaq Llc | Delivery device for controlled deployement of a replacement valve |
USD755384S1 (en) | 2014-03-05 | 2016-05-03 | Edwards Lifesciences Cardiaq Llc | Stent |
WO2015138298A1 (en) | 2014-03-12 | 2015-09-17 | The University Of Connecticut | Method of infusing fibrous substrate with conductive organic particles and conductive polymer; and conductive fibrous substrates prepared therefrom |
CA3161000A1 (en) | 2014-05-19 | 2015-11-26 | Edwards Lifesciences Cardiaq Llc | Replacement mitral valve with annular flap |
US9532870B2 (en) | 2014-06-06 | 2017-01-03 | Edwards Lifesciences Corporation | Prosthetic valve for replacing a mitral valve |
US10441416B2 (en) | 2015-04-21 | 2019-10-15 | Edwards Lifesciences Corporation | Percutaneous mitral valve replacement device |
EP3286767B1 (en) | 2015-04-23 | 2021-03-24 | The University of Connecticut | Highly conductive polymer film compositions from nanoparticle induced phase segregation of counterion templates from conducting polymers |
WO2016172461A1 (en) | 2015-04-23 | 2016-10-27 | The University Of Connecticut | Stretchable organic metals, composition, and use |
US10376363B2 (en) | 2015-04-30 | 2019-08-13 | Edwards Lifesciences Cardiaq Llc | Replacement mitral valve, delivery system for replacement mitral valve and methods of use |
CA2990872C (en) | 2015-06-22 | 2022-03-22 | Edwards Lifescience Cardiaq Llc | Actively controllable heart valve implant and methods of controlling same |
US10092400B2 (en) | 2015-06-23 | 2018-10-09 | Edwards Lifesciences Cardiaq Llc | Systems and methods for anchoring and sealing a prosthetic heart valve |
US10575951B2 (en) | 2015-08-26 | 2020-03-03 | Edwards Lifesciences Cardiaq Llc | Delivery device and methods of use for transapical delivery of replacement mitral valve |
US10117744B2 (en) | 2015-08-26 | 2018-11-06 | Edwards Lifesciences Cardiaq Llc | Replacement heart valves and methods of delivery |
US10350066B2 (en) | 2015-08-28 | 2019-07-16 | Edwards Lifesciences Cardiaq Llc | Steerable delivery system for replacement mitral valve and methods of use |
USD815744S1 (en) | 2016-04-28 | 2018-04-17 | Edwards Lifesciences Cardiaq Llc | Valve frame for a delivery system |
US10350062B2 (en) | 2016-07-21 | 2019-07-16 | Edwards Lifesciences Corporation | Replacement heart valve prosthesis |
CN109789017B (en) | 2016-08-19 | 2022-05-31 | 爱德华兹生命科学公司 | Steerable delivery system for replacing a mitral valve and methods of use |
US10639143B2 (en) | 2016-08-26 | 2020-05-05 | Edwards Lifesciences Corporation | Multi-portion replacement heart valve prosthesis |
US10758348B2 (en) | 2016-11-02 | 2020-09-01 | Edwards Lifesciences Corporation | Supra and sub-annular mitral valve delivery system |
WO2018125012A1 (en) * | 2016-12-28 | 2018-07-05 | Istanbul Teknik Universitesi | Electrical conductive surgical suture production method |
CA3067150A1 (en) | 2017-07-06 | 2019-01-10 | Edwards Lifesciences Corporation | Steerable rail delivery system |
US10867719B2 (en) * | 2017-07-17 | 2020-12-15 | Massachusetts Institute Of Technology | Enhancing performance stability of electroactive polymers by vapor-deposited organic networks |
EP3720390B1 (en) | 2018-01-25 | 2024-05-01 | Edwards Lifesciences Corporation | Delivery system for aided replacement valve recapture and repositioning post- deployment |
CN108125734A (en) * | 2018-02-11 | 2018-06-08 | 四川中盾知识产权服务有限公司 | A kind of heart valve forming ring |
US11051934B2 (en) | 2018-02-28 | 2021-07-06 | Edwards Lifesciences Corporation | Prosthetic mitral valve with improved anchors and seal |
EP3813696A4 (en) | 2018-06-27 | 2022-04-13 | IlluminOss Medical, Inc. | Systems and methods for bone stabilization and fixation |
US11723783B2 (en) | 2019-01-23 | 2023-08-15 | Neovasc Medical Ltd. | Covered flow modifying apparatus |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6139575A (en) * | 1999-04-02 | 2000-10-31 | Medtronic, Inc. | Hybrid mechanical heart valve prosthesis |
US6350282B1 (en) * | 1994-04-22 | 2002-02-26 | Medtronic, Inc. | Stented bioprosthetic heart valve |
US20020133180A1 (en) * | 2001-03-15 | 2002-09-19 | Ryan Timothy R. | Annuloplasty band and method |
US20030066987A1 (en) * | 2001-03-27 | 2003-04-10 | Schmidt Christine E. | Biodegradable, electrically conducting polymer for tissue engineering applications |
US20030212306A1 (en) * | 2002-05-10 | 2003-11-13 | Banik Michael S. | Electroactive polymer based artificial sphincters and artificial muscle patches |
EP1472996A1 (en) * | 2003-04-30 | 2004-11-03 | Medtronic Vascular, Inc. | Percutaneously delivered temporary valve |
Family Cites Families (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3927422A (en) | 1973-12-12 | 1975-12-23 | Philip Nicholas Sawyer | Prosthesis and method for making same |
FR2306671A1 (en) * | 1975-04-11 | 1976-11-05 | Rhone Poulenc Ind | VALVULAR IMPLANT |
US4167045A (en) | 1977-08-26 | 1979-09-11 | Interface Biomedical Laboratories Corp. | Cardiac and vascular prostheses |
US4718907A (en) | 1985-06-20 | 1988-01-12 | Atrium Medical Corporation | Vascular prosthesis having fluorinated coating with varying F/C ratio |
US4743253A (en) | 1986-03-04 | 1988-05-10 | Magladry Ross E | Suture rings for heart valves and method of securing same to heart valves |
US4803096A (en) | 1987-08-03 | 1989-02-07 | Milliken Research Corporation | Electrically conductive textile materials and method for making same |
US4975317A (en) * | 1987-08-03 | 1990-12-04 | Milliken Research Corporation | Electrically conductive textile materials and method for making same |
US5207706A (en) | 1988-10-05 | 1993-05-04 | Menaker M D Gerald | Method and means for gold-coating implantable intravascular devices |
US5306296A (en) | 1992-08-21 | 1994-04-26 | Medtronic, Inc. | Annuloplasty and suture rings |
US5800421A (en) * | 1996-06-12 | 1998-09-01 | Lemelson; Jerome H. | Medical devices using electrosensitive gels |
US5895419A (en) | 1996-09-30 | 1999-04-20 | St. Jude Medical, Inc. | Coated prosthetic cardiac device |
US5766240A (en) | 1996-10-28 | 1998-06-16 | Medtronic, Inc. | Rotatable suturing ring for prosthetic heart valve |
US6781284B1 (en) * | 1997-02-07 | 2004-08-24 | Sri International | Electroactive polymer transducers and actuators |
US6376971B1 (en) * | 1997-02-07 | 2002-04-23 | Sri International | Electroactive polymer electrodes |
US5911930A (en) | 1997-08-25 | 1999-06-15 | Monsanto Company | Solvent spinning of fibers containing an intrinsically conductive polymer |
US6228492B1 (en) | 1997-09-23 | 2001-05-08 | Zipperling Kessler & Co. (Gmbh & Co.) | Preparation of fibers containing intrinsically conductive polymers |
US6267782B1 (en) | 1997-11-20 | 2001-07-31 | St. Jude Medical, Inc. | Medical article with adhered antimicrobial metal |
KR100382568B1 (en) * | 1998-02-23 | 2003-05-09 | 메사츄세츠 인스티튜트 어브 테크놀로지 | Biodegradable shape memory polymers |
US6295474B1 (en) | 1998-03-13 | 2001-09-25 | Intermedics Inc. | Defibrillator housing with conductive polymer coating |
US6015433A (en) * | 1998-05-29 | 2000-01-18 | Micro Therapeutics, Inc. | Rolled stent with waveform perforation pattern |
US6254634B1 (en) * | 1998-06-10 | 2001-07-03 | Surmodics, Inc. | Coating compositions |
US6761736B1 (en) * | 1999-11-10 | 2004-07-13 | St. Jude Medical, Inc. | Medical article with a diamond-like carbon coated polymer |
CA2397377A1 (en) | 2000-01-25 | 2001-08-02 | Edwards Lifesciences Corporation | Bioactive coatings to prevent tissue overgrowth on artificial heart valves |
US6795730B2 (en) * | 2000-04-20 | 2004-09-21 | Biophan Technologies, Inc. | MRI-resistant implantable device |
US20020116028A1 (en) * | 2001-02-20 | 2002-08-22 | Wilson Greatbatch | MRI-compatible pacemaker with pulse carrying photonic catheter providing VOO functionality |
US6827966B2 (en) * | 2001-05-30 | 2004-12-07 | Novartis Ag | Diffusion-controllable coatings on medical device |
US6719786B2 (en) | 2002-03-18 | 2004-04-13 | Medtronic, Inc. | Flexible annuloplasty prosthesis and holder |
US7118595B2 (en) | 2002-03-18 | 2006-10-10 | Medtronic, Inc. | Flexible annuloplasty prosthesis and holder |
WO2003101955A2 (en) * | 2002-03-20 | 2003-12-11 | Massachusetts Institute Of Technology | Molecular actuators, and methods of use thereof |
DE10217828A1 (en) * | 2002-04-16 | 2003-10-30 | Biotronik Mess & Therapieg | electrode line |
WO2003088818A2 (en) * | 2002-04-18 | 2003-10-30 | Mnemoscience Gmbh | Biodegradable shape memory polymeric sutures |
AU2003248750A1 (en) * | 2002-06-27 | 2004-01-19 | J. Luis Guerrero | Ventricular remodeling for artioventricular valve regurgitation |
US6969395B2 (en) * | 2002-08-07 | 2005-11-29 | Boston Scientific Scimed, Inc. | Electroactive polymer actuated medical devices |
US20040068224A1 (en) * | 2002-10-02 | 2004-04-08 | Couvillon Lucien Alfred | Electroactive polymer actuated medication infusion pumps |
US7494459B2 (en) * | 2003-06-26 | 2009-02-24 | Biophan Technologies, Inc. | Sensor-equipped and algorithm-controlled direct mechanical ventricular assist device |
-
2003
- 2003-11-17 US US10/714,767 patent/US7740656B2/en active Active
-
2004
- 2004-11-17 WO PCT/US2004/038587 patent/WO2005049103A2/en active Application Filing
- 2004-11-17 JP JP2006541349A patent/JP2007511329A/en not_active Withdrawn
- 2004-11-17 AU AU2004290583A patent/AU2004290583A1/en not_active Abandoned
- 2004-11-17 CA CA002546322A patent/CA2546322A1/en not_active Abandoned
- 2004-11-17 EP EP04811331A patent/EP1691855A2/en not_active Withdrawn
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6350282B1 (en) * | 1994-04-22 | 2002-02-26 | Medtronic, Inc. | Stented bioprosthetic heart valve |
US6139575A (en) * | 1999-04-02 | 2000-10-31 | Medtronic, Inc. | Hybrid mechanical heart valve prosthesis |
US20020133180A1 (en) * | 2001-03-15 | 2002-09-19 | Ryan Timothy R. | Annuloplasty band and method |
US20030066987A1 (en) * | 2001-03-27 | 2003-04-10 | Schmidt Christine E. | Biodegradable, electrically conducting polymer for tissue engineering applications |
US20030212306A1 (en) * | 2002-05-10 | 2003-11-13 | Banik Michael S. | Electroactive polymer based artificial sphincters and artificial muscle patches |
EP1472996A1 (en) * | 2003-04-30 | 2004-11-03 | Medtronic Vascular, Inc. | Percutaneously delivered temporary valve |
Non-Patent Citations (9)
Title |
---|
ALIKACEM NADIR ET AL: "Tissue reactions to polypyrrole-coated polyesters: A magnetic resonance relaxometry study" ARTIFICIAL ORGANS, vol. 23, no. 10, October 1999 (1999-10), pages 910-919, XP002335968 ISSN: 0160-564X * |
COLLIER J H ET AL: "SYNTHESIS AND CHARACTERIZATION OF POLYPYRROLE-HYALURONIC ACID COMPOSITE BIOMATERIALS FOR TISSUE ENGINEERING APPLICATIONS" JOURNAL OF BIOMEDICAL MATERIALS RESEARCH, WILEY, NEW YORK, NY, US, vol. 50, no. 4, 15 June 2000 (2000-06-15), pages 574-584, XP009001195 ISSN: 0021-9304 * |
DE GIGLIO E ET AL: "Electropolymerization of pyrrole on titanium substrates for the future development of new biocompatible surfaces" BIOMATERIALS, ELSEVIER SCIENCE PUBLISHERS BV., BARKING, GB, vol. 22, no. 19, 1 October 2001 (2001-10-01), pages 2609-2616, XP004296080 ISSN: 0142-9612 * |
JAKUBIEC BARBARA ET AL: "In vitro cellular response to polypyrrole-coated woven polyester fabrics: potential benefits of electrical conductivity" J BIOMED MATER RES; JOURNAL OF BIOMEDICAL MATERIALS RESEARCH SEP 15 1998 JOHN WILEY & SONS INC, NEW YORK, NY, USA, vol. 41, no. 4, 15 September 1998 (1998-09-15), pages 519-526, XP002335967 * |
JIANG XIAOPING ET AL: "Tissue reaction to polypyrrole-coated polyester fabrics: An in vivo study in rats" TISSUE ENGINEERING, vol. 8, no. 4, August 2002 (2002-08), pages 635-647, XP002335970 ISSN: 1076-3279 * |
KAMALESH S ET AL: "Biocompatibility of electroactive polymers in tissues." JOURNAL OF BIOMEDICAL MATERIALS RESEARCH. 5 DEC 2000, vol. 52, no. 3, 5 December 2000 (2000-12-05), pages 467-478, XP002335971 ISSN: 0021-9304 * |
MADDEN JOHN ET AL: "Development of an artificial muscle fiber composed of the conducting polymer actuator polypyrrole" GASTROENTEROLOGY, vol. 122, no. 4 Suppl. 1, April 2002 (2002-04), pages A-164, XP009050713 & DIGESTIVE DISEASE WEEK AND THE 103RD ANNUAL MEETING OF THE AMERICAN GASTROENTEROLOGICAL ASSOCIATION; SAN FRANCISCO, CA, USA; MAY 19-22, 2002 ISSN: 0016-5085 * |
MAROIS Y ET AL: "Endothelial cell behavior on vascular prosthetic grafts: effect of polymer chemistry, surface structure, and surface treatment." ASAIO JOURNAL (AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS : 1992) 1999 JUL-AUG, vol. 45, no. 4, July 1999 (1999-07), pages 272-280, XP009050663 ISSN: 1058-2916 * |
ZHANG ZE ET AL: "In vitro biocompatibility study of electrically conductive polypyrrole-coated polyester fabrics" JOURNAL OF BIOMEDICAL MATERIALS RESEARCH, vol. 57, no. 1, October 2001 (2001-10), pages 63-71, XP002335969 ISSN: 0021-9304 * |
Cited By (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10869764B2 (en) | 2003-12-19 | 2020-12-22 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US9918834B2 (en) | 2004-09-02 | 2018-03-20 | Boston Scientific Scimed, Inc. | Cardiac valve, system and method |
US9622859B2 (en) | 2005-02-01 | 2017-04-18 | Boston Scientific Scimed, Inc. | Filter system and method |
US9808341B2 (en) | 2005-02-23 | 2017-11-07 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US9861473B2 (en) | 2005-04-15 | 2018-01-09 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US9028542B2 (en) | 2005-06-10 | 2015-05-12 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US11337812B2 (en) | 2005-06-10 | 2022-05-24 | Boston Scientific Scimed, Inc. | Venous valve, system and method |
US8460365B2 (en) | 2005-09-21 | 2013-06-11 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US9474609B2 (en) | 2005-09-21 | 2016-10-25 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8672997B2 (en) | 2005-09-21 | 2014-03-18 | Boston Scientific Scimed, Inc. | Valve with sinus |
US10548734B2 (en) | 2005-09-21 | 2020-02-04 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8133270B2 (en) | 2007-01-08 | 2012-03-13 | California Institute Of Technology | In-situ formation of a valve |
US8348999B2 (en) | 2007-01-08 | 2013-01-08 | California Institute Of Technology | In-situ formation of a valve |
US8470023B2 (en) | 2007-02-05 | 2013-06-25 | Boston Scientific Scimed, Inc. | Percutaneous valve, system, and method |
US10226344B2 (en) | 2007-02-05 | 2019-03-12 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US11504239B2 (en) | 2007-02-05 | 2022-11-22 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US8343212B2 (en) | 2007-05-15 | 2013-01-01 | Biotectix, LLC | Polymer coatings on medical devices |
US8414641B2 (en) | 2007-12-21 | 2013-04-09 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
WO2017158148A1 (en) | 2016-03-17 | 2017-09-21 | Centro Cardiologico Monzino | Polymers and uses thereof in manufacturing of 'living' heart valves |
Also Published As
Publication number | Publication date |
---|---|
AU2004290583A1 (en) | 2005-06-02 |
WO2005049103A3 (en) | 2005-11-17 |
EP1691855A2 (en) | 2006-08-23 |
US20050107872A1 (en) | 2005-05-19 |
US7740656B2 (en) | 2010-06-22 |
CA2546322A1 (en) | 2005-06-02 |
JP2007511329A (en) | 2007-05-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US7740656B2 (en) | Implantable heart valve prosthetic devices having intrinsically conductive polymers | |
US5207706A (en) | Method and means for gold-coating implantable intravascular devices | |
US5464438A (en) | Gold coating means for limiting thromboses in implantable grafts | |
US6322588B1 (en) | Medical devices with metal/polymer composites | |
Huang et al. | Surface modification of biomaterials by plasma immersion ion implantation | |
CA1240805A (en) | Vascular prosthesis | |
US20180345624A1 (en) | Composite ePTFE/Textile Prosthesis | |
CA1102052A (en) | Artificial vascular and patch grafts | |
EP1023879B1 (en) | Implantable medical device with enhanced biocompatibility and biostability | |
DE60026065T2 (en) | ELECTROPOLYMERIZABLE MONOMERS AND POLYMER COATINGS ON IMPLANTABLE EQUIPMENT | |
CA1111604A (en) | Artificial tendon prostheses comprising carbon coated organo polymeric fibers | |
JP2001501516A (en) | Coated prosthetic heart valve | |
US20040088046A1 (en) | Synthetic leaflets for heart valve repair or replacement | |
EP2533821B1 (en) | Medical device made of eptfe partially coated with an antimicrobial material | |
EP1229944A2 (en) | Medical article with a diamond-like carbon coating | |
Justin et al. | Electroconductive blends of poly (HEMA-co-PEGMA-co-HMMAco-SPMA) and poly (Py-co-PyBA): In vitro biocompatibility | |
CN110152065A (en) | A kind of bionical micro-nano lamination hydrophobic biological valve and preparation method thereof | |
EP1554990A2 (en) | Implantable medical device with enhanced biocompatibility and biostability | |
CN103623410A (en) | Antibacterial composition, implant material and preparation method of implant material | |
CN110152064B (en) | Heart valve modified by hydrophilic composite network lamination and preparation method thereof | |
US11419534B2 (en) | Core-shell nanowire, method of forming core-shell nanowire, and stretchable composite comprising core-shell nanowire | |
CN103611189A (en) | Bacteriostatic composition, implant material and preparation method thereof | |
Marino et al. | Electrical augmentation of the antimicrobial activity of silver-nylon fabrics | |
Hofman et al. | Safety and intracardiac function of a silicone-polyurethane elastomer designed for vascular use | |
US20130202660A1 (en) | Functional nanostructured chitosan coatings for medical instruments and devices |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AK | Designated states |
Kind code of ref document: A2 Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW |
|
AL | Designated countries for regional patents |
Kind code of ref document: A2 Designated state(s): GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG |
|
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
WWE | Wipo information: entry into national phase |
Ref document number: 2546322 Country of ref document: CA |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2006541349 Country of ref document: JP |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
WWW | Wipo information: withdrawn in national office |
Country of ref document: DE |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2004290583 Country of ref document: AU |
|
ENP | Entry into the national phase |
Ref document number: 2004290583 Country of ref document: AU Date of ref document: 20041117 Kind code of ref document: A |
|
WWP | Wipo information: published in national office |
Ref document number: 2004290583 Country of ref document: AU |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2004811331 Country of ref document: EP |
|
WWP | Wipo information: published in national office |
Ref document number: 2004811331 Country of ref document: EP |