Source: http://www.google.com/patents/US20070239269?dq=5572193
Timestamp: 2014-03-09 16:01:13
Document Index: 721853369

Matched Legal Cases: ['art 100', 'art 100', 'art 100', 'art 100', 'art 100', 'art 100']

Patent US20070239269 - Stented Valve Having Dull Struts - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA system for replacing a pulmonary valve includes a conduit having a lumen, a delivery catheter and a replacement valve device disposed on the delivery catheter. The replacement valve device includes a prosthetic valve connected to a valve support region of an expandable support structure. The valve...http://www.google.com/patents/US20070239269?utm_source=gb-gplus-sharePatent US20070239269 - Stented Valve Having Dull StrutsAdvanced Patent SearchPublication numberUS20070239269 A1Publication typeApplicationApplication numberUS 11/278,984Publication dateOct 11, 2007Filing dateApr 7, 2006Priority dateApr 7, 2006Publication number11278984, 278984, US 2007/0239269 A1, US 2007/239269 A1, US 20070239269 A1, US 20070239269A1, US 2007239269 A1, US 2007239269A1, US-A1-20070239269, US-A1-2007239269, US2007/0239269A1, US2007/239269A1, US20070239269 A1, US20070239269A1, US2007239269 A1, US2007239269A1InventorsMark Dolan, Jeffrey AllenOriginal AssigneeMedtronic Vascular, Inc.Export CitationBiBTeX, EndNote, RefManReferenced by (26), Classifications (10), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetStented Valve Having Dull StrutsUS 20070239269 A1Abstract A system for replacing a pulmonary valve includes a conduit having a lumen, a delivery catheter and a replacement valve device disposed on the delivery catheter. The replacement valve device includes a prosthetic valve connected to a valve support region of an expandable support structure. The valve support region includes a plurality of protective struts disposed between a first stent region and a second stent region. A method for replacing a pulmonary valve includes implanting a conduit and delivering a replacement valve device to the conduit. The replacement valve device includes a valve connected to a valve support region that includes a plurality of protective struts. The method also includes deploying the prosthetic valve device from a delivery catheter into the lumen, positioning the prosthetic valve device within the conduit lumen and expanding the prosthetic valve device into contact with the inner wall of the conduit. Images(8) Claims(18)
DETAILED DESCRIPTION The invention will now be described by reference to the drawings wherein like numbers refer to like structures. Referring to the drawings, FIG. 1 is a schematic representation of the interior of human heart 100. Human heart 100 includes four valves that work in synchrony to control the flow of blood through the heart. Tricuspid valve 104, situated between right atrium 118 and right ventricle 116, and mitral valve 106, between left atrium 120 and left ventricle 114 facilitate filling of ventricles 116 and 114 on the right and left sides, respectively, of heart 100. Aortic valve 108 is situated at the junction between aorta 112 and left ventricle 114 and facilitates blood flow from heart 100, through aorta 112 to the peripheral circulation. Pulmonary valve 102 is situated at the junction of right ventricle 116 and pulmonary artery 110 and facilitates blood flow from heart 100 through the pulmonary artery 110 to the lungs for oxygenation. The four valves work by opening and closing in harmony with each other. During diastole, tricuspid valve 104 and mitral valve 106 open and allow blood flow into ventricles 114 and 116, and the pulmonic valve and aortic valve are closed. During systole, shown in FIG. 1, aortic valve 108 and pulmonary valve 102 open and allow blood flow from left ventricle 114, and right ventricle 116 into aorta 112 and pulmonary 110, respectively. The right ventricular outflow tract is the segment of pulmonary artery 110 that includes pulmonary valve 102 and extends to branch point 122, where pulmonary artery 110 forms left and right branches that carry blood to the left and right lungs respectively. A defective pulmonary valve or other abnormalities of the pulmonary artery that impede blood flow from the heart to the lungs sometimes require surgical repair or replacement of the right ventricular outflow tract with prosthetic conduit 202, as shown in FIG. 2A-C. Such conduits comprise tubular structures of biocompatible materials, with a hemocompatible interior surface. Examples of appropriate biocompatible materials include polytetrafluoroethylene (PTFE), woven polyester fibers such as Dacron� fibers (E.I. Du Pont De Nemours & Co., Inc.), and xenograft vein cross linked with glutaraldehyde. One common conduit is a homograft, which is a vessel harvested from a cadaver and treated for implantation into a recipient's body. These conduits may contain a valve at a fixed position within the interior lumen of the conduit that functions as a replacement pulmonary valve. One such conduit 202 comprises a bovine jugular vein with a trileaflet venous valve preserved in buffered glutaraldehyde. Other valves are made of synthetic materials and are attached to the wall of the lumen of the conduit. The conduits may also include materials having a high X-ray attenuation coefficient (radiopaque materials) that are woven into or otherwise attached to the conduit, so that it can be easily located and identified. As shown in FIGS. 2A and 2B, conduit 202, which houses valve 204 within its inner lumen, is installed within a patient by sewing the distal end of conduit 202 to pulmonary artery 110, and, as shown in FIG. 2C, attaching the proximal end of conduit 202 to heart 100 so that the lumen of conduit 202 connects to right ventricle 116. Over time, implanted prosthetic conduits and valves are frequently subject to calcification, causing the affected conduit or valve to lose flexibility, become misshapen, and lose the ability to function effectively. Additional problems are encountered when prosthetic valves are implanted in young children. As the child grows, the valve will ultimately be too small to handle the increased volume of blood flowing from the heart to the lungs. In either case, the valve needs to be replaced. The current invention discloses devices and methods for percutaneous catheter based placement of stented valves for regulating blood flow through a pulmonary artery. In a preferred embodiment, the valves are attached to an expandable support structure and they are placed in a valved conduit that is been attached to the pulmonary artery, and that is in fluid communication with the right ventricle of a heart. The support structure can be expanded such that any pre-existing valve in the conduit is not disturbed, or it can be expanded such that any pre-existing valve is pinned between the support structure and the interior wall of the conduit. The delivery catheter carrying the stented valve is passed through the venous system and into a patient's right ventricle. This may be accomplished by inserting the delivery catheter into either the jugular vein or the subclavian vein and passing it through superior vena cava into right atrium. The catheter is then passed through the tricuspid valve, into right ventricle, and out of the ventricle into the conduit. Alternatively, the catheter may be inserted into the femoral vein and passed through the common iliac vein and the inferior vena cava into the right atrium, then through the tricuspid valve, into the right ventricle and out into the conduit. The catheters used for the procedures described herein may include radiopaque markers as are known in the art, and the procedure may be visualized using fluoroscopy, echocardiography, ultrasound, or other suitable means of visualization. FIG. 3 is a side view of one embodiment of a replacement valve device 300, in accordance with the present invention. Replacement valve 300 is suitable for use in either a prosthetic conduit such as conduit 202, in the pulmonary artery 110, or to replace other valves in the cardiac structure. Replacement valve 300 may also be referred to herein as stented valve 300. Prosthetic valve 304 is situated within the lumen of expandable tubular support structure 302. In one embodiment of the invention, support structure 302 is a stent made of a flexible, biocompatible material that has �shape memory�, such as nitinol. In one embodiment, prosthetic valve 304 comprises three leaflets of a flexible material. Support structure 302 comprises a first stent region 308, a second stent region 310 and a valve support region 306 disposed between the first stent region 308 and the second stent region 31 0. Valve support region 306 comprises a stent framework composed of a plurality of protective struts 312. The stent can be made by any means known in the art, including chemical etching, and laser cutting a tube of material. An example of a suitable stent for use in a system for replacing cardiac valves is shown in the U.S. Patent Application having the publication No. 2005/0203605, titled �RADIALLY CRUSH RESISTANT STENT,� for Dolan, the contents of which are incorporated herein by reference. Embodiments of the current invention have stents with struts that are dulled or otherwise broadened such that the edges will not easily cut into the delicate valve structure. In one embodiment, protective struts 312 have a rounded transverse cross section to prevent the struts from cutting or otherwise damaging the valve or graft material on the stent when it is crimped into a delivery configuration or when it is expanded. One method for creating rounded edges on the struts of a stent is electropolishing, where an electric current is run through the stent in a conductive aqueous bath made of salts that are similar to the base metal being polished. A cathode is positioned either outside the stent diameter or inside the stent diameter. As the electricity jumps from the stent (acting as an anode) to the cathode, material is removed. Material preferentially comes off of the peaks, which are also the square edges of the stent. As the material is removed from the square edge, it becomes rounded or dull. Adjusting the position of the cathode can adjust how the material is removed from the peaks (i.e., more material is removed from the inside peaks if the cathode is inside the stent diameter). Another method for rounding off the square edges of stent struts is tumbling, wherein the stent is first expanded to a workable diameter. The stent is then placed in a mixture of media that typically includes silicon carbide and water with silicon carbide impregnated alumina or plastic. The mixture is placed in drum that is rotated at a speed that will maximize tumbling action. The action of the media rubbing against the stent will remove the square cut edges from the strut. The way the material is removed from the stent can be adjusted based on how far the stent is expanded before tumbling and how much water is added to the tumbling mixture. This process is described in greater detail in the international patent application No. PCT/US03/41649, titled �METHOD FOR MANUFACTURING AN ENDOVASCULAR SUPPORT DEVICE,� the contents of which are incorporated herein by reference. The current invention provides valve support structures having transverse cross sections (a cross section taken at a right angle to the long axis of a member) with rounded edges so that the cross sections do not have four right angle corners like a strut having a square or rectangular cross section would. FIGS. 4 to 6 illustrate various embodiments of strut 312 for use in valve support region 306. FIG. 4 illustrates a protective strut 312A. In this embodiment, protective strut 312A has a transverse cross section with rounded edges 313A on the outer surface 314A and on the inner surface 316A that contacts the valve. The rounded edges, exist as arched transitions between the flat planes 314A-317A. FIG. 5 illustrates a protective strut 312B. In this embodiment, protective strut 312B has an oval shaped transverse cross section with rounded ends 313B. In one embodiment of the invention having struts with an oval shaped transverse cross section, the interior and exterior surfaces are essentially flat, and in another they are gently rounded. In another embodiment, the transverse cross section of the struts is circular or round in shape. FIG. 6 illustrates a protective strut 312C. In this embodiment, protective strut 312C has an elongate cross section with rounded edges 313C on the inner surface 316C that contacts the valve and squared edges 318C on the outer surface 314C. In one preferred embodiment of the invention, the stent members in the first and second stent regions have transverse cross sections with the same shape as the transverse cross section of the protective struts. First stent region 308 and second stent region 310 each comprise a stent framework composed of a plurality of struts 320. In one embodiment, struts 320 have a cross section similar to, or the same as, the cross section of protective strut 312. In another embodiment, struts 320 have a square or rectangular cross section. Those with skill in the art will recognize that the valve support region with the protective struts may be disposed between a variety of stent regions other than those described without departing from the scope of the present invention. The stent framework of first stent region 308 and second stent region 310 may be composed of self-expanding material and manufactured from, for example, a nickel titanium alloy and/or other alloy(s) that exhibit superelastic behavior. Other suitable materials for first stent region 308 and second stent region 310 include, but are not limited to, ceramic, tantalum, stainless steel, titanium ASTM F63-83 Grade 1, niobium, high carat gold K 19-24, platinum iridium alloys, nitinol, and cobalt based alloys. Furthermore, the stent framework material may include polymeric biocompatible materials recognized in the art for such devices. The support structure 302 and/or stent framework may also include materials having a high X-ray attenuation coefficient (radiopaque materials) so that the replacement valve device can be easily located and identified. Examples of suitable materials include, but are not limited to, gold, silver, tantalum oxide, tantalum, platinum, platinum/iridium alloy, tungsten and combinations thereof. The radiopaque material may be visualized by fluoroscopy, IVUS, and other methods known in the art. FIG. 7 illustrates a cross-sectional view of another embodiment of a protective strut 712 suitable for use in the valve support region 306 illustrated in FIG. 3. Protective strut 712 comprises a strut member 714 having a protective layer 716 surrounding the strut member to provide a generally rounded or oval cross section. Protective layer 712 encloses the strut member 712 in such a manner as to cover the corners and edges of the strut member thereby reducing or eliminating contact of the prosthetic valve with the edges of the strut that may damage the valve during crimping and expansion of the stented valve. In one embodiment, protective layer 716 comprises a biodegradable coating that erodes over a period of time after implantation of the stented valve within the vessel or conduit. Examples of biodegradable polymers suitable for use include but are not limited to bioabsorbable polymers such polyphosphate ester, polyhydroxybutyrate valerate, and poly (L-lactic acid) to form a uniform coating on the exterior surface of strut members 714 that erodes over a defined period of time. In one embodiment, the biodegradable polymer includes a therapeutic agent that is released as the biodegradable polymer erodes. The therapeutic agent comprises one or more drugs, polymers, a component thereof, a combination thereof, and the like. For example, the therapeutic agent can include a mixture of a drug and a polymer as known in the art. Some exemplary drug classes that may be included are antiangiogenesis agents, antiendothelin agents, antimitogenic factors, antioxidants, antiplatelet agents, antiproliferative agents, antisense oligonucleotides, antithrombogenic agents, calcium channel blockers, clot dissolving enzymes, growth factors, growth factor inhibitors, nitrates, nitric oxide releasing agents, vasodilators, virus-mediated gene transfer agents, agents having a desirable therapeutic application, and the like. Specific examples of drugs include abciximab, angiopeptin, colchicine, eptifibatide, heparin, hirudin, lovastatin, methotrexate, streptokinase, taxol, ticlopidine, tissue plasminogen activator, trapidil, urokinase, and growth factors VEGF, TGF-beta, IGF, PDGF, and FGF. FIG. 8 is a side view of another embodiment of a replacement valve device 800, in accordance with the present invention. Replacement valve 800 is suitable for use in either a prosthetic conduit such as conduit 202, in the pulmonary artery 110, or to replace other valves in the cardiac structure. Replacement valve 800 may also be referred to herein as stented valve 800. Prosthetic valve 804 is situated within the lumen of expandable tubular support structure 802. In one embodiment of the invention, support structure 802 is a stent made of a flexible, biocompatible material that has �shape memory�, such as nitinol. In one embodiment, prosthetic valve 804 comprises three leaflets of a flexible material. Support structure 802 comprises a first stent region 808, a second stent region 810 and a valve support region 806 disposed between the first stent region 808 and the second stent region 810. In this embodiment, valve support region 806, first stent region 808 and second stent region 810 comprise a stent framework composed of a plurality of protective struts 812. The stent can be made by any means known in the art, including chemical etching, and laser cutting a tube of material. Protective struts 812 are dulled or otherwise broadened such that the edges will not easily cut into the delicate valve structure. In one embodiment, protective struts 812 have a rounded transverse cross section to prevent the struts from cutting or otherwise damaging the valve or graft material on the stent when it is crimped into a delivery configuration or when it is expanded. The method for creating rounded edges on the protective struts 812 of support structure 802 may be the same or similar to the methods described above for protective struts 312. The protective struts 812 of support structure 802 have transverse cross sections the same as or similar to those described above and illustrated in FIGS. 4-6. FIG. 9 is a flowchart illustrating method 900 for treating right ventricular outflow tract abnormalities by replacing a pulmonary valve, in accordance with the present invention. Method 900 starts at 901. Method 900 begins with the implantation of a conduit into the target region of a vessel. In one embodiment, and as illustrated in FIGS. 1-2C, the conduit is implanted to replace a pulmonary artery (Block 910). Method 900 continues with the insertion and positioning of a distal end of a delivery tube at the treatment site (Block 920). The distal portion of a delivery catheter is inserted into the vascular system of the patient, and is then passed through the venous system and into a patient's right ventricle 116. This may be accomplished by inserting delivery catheter into either the jugular vein or the subclavian vein, and passing it through the superior vena cava into right atrium 118. The catheter is then passed through tricuspid valve 104, into right ventricle 116, and out of the ventricle into either conduit 202 or the pulmonary artery. Alternatively, delivery catheter may be inserted into the femoral vein and passed through the common iliac vein and the inferior vena cava into right atrium 118, then through tricuspid valve 104, into right ventricle 116, and out into conduit 202. The catheters used for the procedures described herein may include radiopaque markers as are known in the art, and the procedure may be visualized using fluoroscopy, echocardiography, ultrasound, or other suitable means of visualization. The distal portion of delivery catheter is then positioned at the treatment site within conduit 202. Next, stented valve 300 is deployed from the delivery catheter (Block 930), and expanded into position within conduit 202 (Block 940). Stented valve 300 is delivered to the conduit 202 or vessel in a collapsed state. Stented valve 300 expands upon deployment from the catheter. Stented valve 300 may include radiopaque markers to aid in the visualization of the stented valve during implantation. Method 900 ends at Block 950. While the invention has been described with reference to particular embodiments, it will be understood by one skilled in the art that variations and modifications may be made in form and detail without departing from the spirit and scope of the invention. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS7799072 *May 18, 2006Sep 21, 2010The Cleveland Clinic FoundationApparatus and methods for repairing the function of a diseased valve and method for making sameUS8414645Aug 27, 2010Apr 9, 2013Medtronic, Inc.Transcatheter valve delivery systems and methodsUS8465541Apr 19, 2010Jun 18, 2013Medtronic, Inc.Transcatheter prosthetic heart valve delivery system and method with expandable stability tubeUS8491650Apr 8, 2010Jul 23, 2013Medtronic, Inc.Transcatheter prosthetic heart valve delivery system and method with stretchable stability tubeUS8512400Apr 9, 2010Aug 20, 2013Medtronic, Inc.Transcatheter heart valve delivery system with reduced area moment of inertiaUS8512401Apr 12, 2010Aug 20, 2013Medtronic, Inc.Transcatheter prosthetic heart valve delivery system with funnel recapturing feature and methodUS8562673Sep 21, 2010Oct 22, 2013Medtronic, Inc.Stented transcatheter prosthetic heart valve delivery system and methodUS8568474Apr 26, 2011Oct 29, 2013Medtronic, Inc.Transcatheter prosthetic heart valve post-dilatation remodeling devices and methodsUS8579963Apr 13, 2010Nov 12, 2013Medtronic, Inc.Transcatheter prosthetic heart valve delivery device with stability tube and methodUS8623075Apr 21, 2011Jan 7, 2014Medtronic, Inc.Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valveWO2010097694A1 *Feb 26, 2010Sep 2, 2010Stellenbosch UniversityA heart valveWO2011025945A1Aug 27, 2010Mar 3, 2011Medtronic Inc.Transcatheter valve delivery systems and methodsWO2011035327A1Sep 21, 2010Mar 24, 2011Medtronic Inc.Stented transcatheter prosthetic heart valve delivery system and methodWO2011106354A1Feb 23, 2011Sep 1, 2011Medtronic Inc.Catheter-based heart valve therapy system with sizing balloonWO2011126749A1Mar 23, 2011Oct 13, 2011Medtronic Inc.Transcatheter heart valve delivery system with reduced area moment of inertiaWO2011126758A1Mar 24, 2011Oct 13, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery system with recapturing feature and methodWO2011130006A1Mar 30, 2011Oct 20, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery device with stability tubeWO2011130093A1Apr 7, 2011Oct 20, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery device with funnel recapturing feature and methodWO2011133368A1Apr 13, 2011Oct 27, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery system with expandable stability tubeWO2011139746A1Apr 27, 2011Nov 10, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery device with passive trigger releaseWO2011139747A1Apr 27, 2011Nov 10, 2011Medtronic Inc.Transcatheter prosthetic heart valve delivery device with biased release featuresWO2011153210A1Jun 1, 2011Dec 8, 2011Medtronic Inc.Transcatheter delivery system and method with controlled expansion and contraction of prosthetic heart vavleWO2012145545A1Apr 19, 2012Oct 26, 2012Medtronic Inc.Transcatheter prosthetic heart valve delivery system with flush portWO2012145546A1Apr 19, 2012Oct 26, 2012Medtronic Inc.Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valveWO2012145549A1Apr 19, 2012Oct 26, 2012Medtronic Inc.Prosthetic heart valve delivery system with spacingWO2012148783A1Apr 19, 2012Nov 1, 2012Medtronic Inc.Transcatheter prosthetic heart valve post-dilatation remodeling devices and methods* Cited by examinerClassifications U.S. Classification623/2.11, 623/2.38, 623/1.26International ClassificationA61F2/24, A61F2/84Cooperative ClassificationA61F2250/006, A61F2/2475, A61F2/2418, A61F2/2412European ClassificationA61F2/24DLegal EventsDateCodeEventDescriptionApr 7, 2006ASAssignmentOwner name: MEDTRONIC VASCULAR, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DOLAN, MARK J.;ALLEN, JEFFREY W.;REEL/FRAME:017434/0634Effective date: 20060406RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google