Source: http://www.google.com/patents/US20070239273?dq=6150774
Timestamp: 2016-07-29 14:07:38
Document Index: 190645816

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

Patent US20070239273 - Riveted Stent Valve For Percutaneous Use - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA system and method for treating a vascular condition includes a conduit having an inner wall defining lumen and a replacement valve device. The replacement valve device includes a prosthetic valve connected to an expandable support structure; the expandable support structure includes at least one valve...http://www.google.com/patents/US20070239273?utm_source=gb-gplus-sharePatent US20070239273 - Riveted Stent Valve For Percutaneous UseAdvanced Patent SearchPublication numberUS20070239273 A1Publication typeApplicationApplication numberUS 11/278,856Publication dateOct 11, 2007Filing dateApr 6, 2006Priority dateApr 6, 2006Also published asUS7591848Publication number11278856, 278856, US 2007/0239273 A1, US 2007/239273 A1, US 20070239273 A1, US 20070239273A1, US 2007239273 A1, US 2007239273A1, US-A1-20070239273, US-A1-2007239273, US2007/0239273A1, US2007/239273A1, US20070239273 A1, US20070239273A1, US2007239273 A1, US2007239273A1InventorsJeffrey AllenOriginal AssigneeMedtronic VascularExport CitationBiBTeX, EndNote, RefManPatent Citations (6), Referenced by (151), Classifications (11), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetRiveted Stent Valve For Percutaneous Use
DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS [0034] The invention will now be described by reference to the drawings wherein like numbers refer to like structures. [0035] 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. [0036] 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. [0037] 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. [0038] 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 bovine 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. [0039] One such conduit 202 comprises a bovine jugular vein with a trileaflet venous valve preserved in buffered glutaraldehyde. Other valves are made of xeno-pericardial tissue and are attached to the wall of the lumen of the conduit. Still other valves may be made at least partially from some synthetic material. 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. [0040] 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. [0041] 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. [0042] 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. [0043] 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. [0044] FIG. 3 illustrates a cross section of one embodiment of a system 300 for treating a vascular condition within heart 100 illustrated in FIG. 1. System 300 illustrated in FIG. 3 is described herein with reference to a bioprosthetic conduit for replacing a portion of a pulmonary artery. Those with skill in the art will recognize that the invention may be adapted to other vessels of a body that require a replacement valve. [0045] System 300 is illustrated in an expanded configuration as it would appear in place within a bioprosthetic conduit. System 300 comprises a bioprosthetic conduit 310 and a stented valve 320. Conduit 310 comprises an elongate tubular structure that includes an inner wall 312 that defines a lumen 314. Lumen 314 allows fluid communication between the right ventricle and the pulmonary artery. Conduit 310 includes a first end 316 for attaching to ventricle 110 and a second end 318 for attaching to pulmonary artery 122. [0046] Referring to FIG. 4, stented valve 320 comprises a stent framework 330 and a prosthetic valve 350. In one embodiment of the invention, stent framework 330 is a stent made of a flexible, biocompatible material that has “shape memory.” The stent framework 330 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 stent framework 330 include, but are not limited to, a nitinol alloy, a stainless steel, a cobalt-based alloy, and an MP35N� alloy. Furthermore, the stent framework material may include polymeric biocompatible materials recognized in the art for such devices. [0047] Stent framework 330 comprises a first stent region 332, a second stent region 334 and a valve support region 340 disposed between the first stent region 332 and the second stent region 334. Valve support region 340 comprises a stent framework composed of a plurality of valve support struts 342. First stent region 332 and second stent region 334 each comprise a stent framework composed of a plurality of struts 336. [0048] In one embodiment, prosthetic valve 350 comprises a bovine jugular vein with a trileaflet venous valve preserved in buffered glutaraldehyde. In other embodiments, prosthetic valve 350 comprises a valve made of synthetic materials and attached to the stent framework 330. Prosthetic valve 350 is operably attached to valve support region 340 of the stent framework 330 by a plurality of valve attachment devices 360 disposed within a plurality of strut openings 348. [0049] Referring to FIG. 5, there is illustrated a detailed view of valve support region 340. As illustrated, valve support region 340 comprises a plurality of strut members 342. In this embodiment, each strut member 342 includes a plurality of strut openings 348. Strut openings 348 are sized to receive one of the attachment devices 360. Strut openings 348 are spaced apart along strut member 342. Strut openings may be formed in the strut members by any means known in the art. In one embodiment, strut openings are laser cut. In other embodiments, the strut openings are drilled or stamped into the strut members. Those with skill in the art will recognize that the location and number of strut openings may vary depending on the application. For example, the location and number of openings may depend on factors such as, the size of the strut and the size of the valve to be secured to the valve support. Referring to FIG. 8, FIG. 8 illustrates one embodiment of an attachment device 360 for securing prosthetic valve 350 to valve support 340. [0050] In one embodiment, attachment device 360 comprises a rivet device and the prosthetic valve is secured to the stent framework by a plurality of the devices. In one embodiment, a stent graft is also secured to the stent framework by a plurality of rivet devices. In another embodiment, attachment device 360 comprises a head portion 362, a pin portion 364 and a flange portion 368. Attachment device 360 is made of a flexible, biocompatible material that has “shape memory.” Suitable materials for attachment device 360 include, but are not limited to, a nitinol alloy, a stainless steel, a cobalt-based alloy, an MP35N� alloy or a combination thereof. [0051] Head portion 362 comprises a broad flat head configured in a nail-head like fashion. In one embodiment, head portion 362 is configured to include rounded edges on at least those edges that are in contact with the prosthetic valve. In another embodiment, head portion 362 includes comprises a radiopaque material to aid in the visualization of the stented valve during implantation. In one embodiment, head portion includes materials having a high X-ray attenuation coefficient (radiopaque materials) so that the stented valve 320 can be easily located and positioned within conduit 310. The head portion may include radiopaque metals such as, for example, gold and platinum. [0052] Pin portion 364 extends perpendicularly to head portion 362. Pin portion 364 may comprise a hollow tube or a solid cylinder. In one embodiment, pin portion 364 includes a sharp end portion configured for tissue penetration. In one embodiment, pin portion 364 is configured to penetrate prosthetic valve 350 during attachment of the prosthetic valve 350 to valve support region 340 of the stent framework 330. [0053] In one embodiment, flange portion 368 extends from pin portion 364. In one embodiment, flange portion 368 comprises a shape memory material that in a first configuration, (an insertion configuration), is sized to pass through opening 348 and after insertion forms a flange to assume a second configuration, (an attachment configuration), that is unable to pass back through opening 348. [0054] FIGS. 10A and 10B illustrate one embodiment of an attachment device 1060 for securing a prosthetic valve to a stent framework. Attachment device 1060 comprises a head portion 1062, a pin portion 1064 and a flange portion 1068. FIG. 10A illustrates the attachment device 1060 where the flange portion 1068 is in an insertion configuration and FIG. 10B illustrates the attachment device 1060 where the flange portion 1068 is in an attachment configuration. [0055] FIGS. 11A and 11B illustrate another embodiment of an attachment device 1160 for securing a prosthetic valve to a stent framework. Attachment device 1160 comprises a head portion 1162, a pin portion 1164 and a flange portion 1168. In this embodiment, pin portion 1164 includes a barbed end portion 1070. Barbed end portion 1070 is configured to penetrate the inner wall 312 of the prosthetic conduit 310 upon expansion of the stented valve into contact with the conduit. In one embodiment, barbed end portion comprises a shape memory material such as, for example, nitinol. In one embodiment, flange portion 1168 comprises a sleeve operably attached to the outer surface of pin portion 1164. In another embodiment, pin portion 364 comprises a core portion that forms barb 1070 and an outer portion that forms flange portion 1168. In one embodiment, barbed end portion 1070 anchors the stented valve in the conduit to prevent or reduce migration of the valve along the conduit after implantation. [0056] Returning to FIG. 8, an attachment device 360 is illustrated in the attachment configuration. During manufacture of the stented valve, the prosthetic valve 350 is positioned within the lumen of the stent framework 330 in the desired location. Then, to secure the prosthetic valve 350 to the valve support region 340 of stent framework 330 the end of the pin portion opposite the head portion is aligned with one of the plurality of stent openings and the pin portion is passed through the tissue of the prosthetic valve and through the stent opening. Once the end of the pin portion is through the stent opening the flange portion assumes the attachment configuration, such as the attachment configurations illustrated in FIGS. 8, 10B and 11B. [0057] Referring to FIG. 9, FIG. 9 illustrates a detailed view of a portion of one embodiment of a stented valve 900 having an attachment device 960 for securing prosthetic valve 950 to valve support 940. In one embodiment, attachment device 960 comprises the attachment device 1160 illustrated in FIGS. 11A and 11B. In one embodiment, the stented valve 900 comprises a self-expanding stent framework. During delivery of the self-expanding stented valve 900 to the treatment site, the stented valve is restrained using a retractable sheath 980. Retractable sheath 980 also restrains barbs 970 and prevents the barbs from contacting the inner walls of the patient's vasculature during delivery of the stented valve to the treatment site. In one embodiment, barbs 970 are comprises of a resilient material having shape memory. In one embodiment, barbs 970 are delivered to the treatment site in a bent delivery configuration, and upon retraction of sheath 980 assume a substantially straight insertion configuration, as shown. [0058] Referring to FIG. 6, stented valve 620 comprises a stent framework 630 and a prosthetic valve 650. In one embodiment of the invention, stent framework 630 is a stent made of a flexible, biocompatible material that has “shape memory.” The stent framework 630 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 stent framework 630 include, but are not limited to, a nitinol alloy, a stainless steel, a cobalt-based alloy, and an MP35N� alloy. Furthermore, the stent framework material may include polymeric biocompatible materials recognized in the art for such devices. [0059] Stent framework 630 comprises a first stent region 632, a second stent region 634 and a valve support region 640 disposed between the first stent region 632 and the second stent region 634. Valve support region 640 comprises a stent framework composed of a plurality of valve support struts 642. First stent region 632 and second stent region 634 each comprise a stent framework composed of a plurality of valve end support struts 636. [0060] In one embodiment, prosthetic valve 650 comprises a bovine jugular vein with a trileaflet venous valve preserved in buffered glutaraldehyde. In other embodiments, prosthetic valve 650 comprises a valve made of synthetic materials and attached to the stent framework 630. In this embodiment, prosthetic valve 650 comprises an elongate body portion 652 having a centrally located valve 654 within central region 655. Elongate body portion has a first end 656 and a second end 658. In this embodiment, a central region 655 of prosthetic valve 650 is attached to the stent framework 630 at valve support region 640 by a plurality of valve attachment devices 660. In one embodiment, valve support region is the same as or similar to that described above and illustrated in FIG. 5. Attachment devices 660 used for securing central region 655 to valve support region 640 may be similar to or the same as those described above and illustrated in FIGS. 8 to 11B. [0061] First end 656 of prosthetic valve 650 is attached to first stent region 632 and second end 658 is attached to second stent region 634 by a plurality of valve attachment devices 660. Attachment devices 660 may be similar to or the same as those described above and illustrated in FIGS. 8 to 11B. [0062] Referring to FIG. 7 there is a detailed view of the valve end support struts 636 located at the outer stent framework for both the first stent region 632 and the second stent region 634. First stent region 632 and second stent region comprise a plurality of struts. In one embodiment the plurality of struts include valve end support struts 636. Valve end support struts 636 are located adjacent the ends of the stent framework to provide attachment support to the ends of the stented valve. In one embodiment, the apex of each strut comprising the first and second stent region includes a valve end support strut 636. Each valve end support strut 636 includes at least one strut opening 648. Strut openings 648 are sized to receive one of the attachment devices 660. In one embodiment, strut openings 648 are spaced apart along strut 636. Strut openings may be formed in the strut members by any means known in the art. In one embodiment, strut openings are laser cut. [0063] In other embodiments, the strut openings are drilled or stamped into the strut members. Those with skill in the art will recognize that the location and number of strut openings may vary depending on the application. For example, the location and number of openings may depend on factors such as, the size of the strut and the size of the prosthetic valve to be secured to the valve support. In one embodiment, the valve end support strut includes an enlarged region 638 around each of the strut openings 648. Enlarged regions 638 of the valve end support struts 636 provide an increased surface for supporting the tissue of the prosthetic valve when sandwiched between the strut surface and the head of the attachment device 660. [0064] FIG. 12 is a flowchart illustrating method 1200 for treating right ventricular outflow tract abnormalities by replacing a pulmonary valve, in accordance with the present invention. Method 1200 begins at step 1201. At step 1210, a bioprosthetic conduit is implanted into a target region of a vessel. [0065] Next, a stented valve is delivered into a target site within a lumen of the bioprosthetic conduit, at step 1220. In one embodiment, the stented valve is delivered percutaneously via a delivery catheter as are known in the art. In one embodiment, the target site within the conduit lumen comprises that portion of the lumen containing a pulmonary valve. [0066] At step 1230, the stented valve is expanded to position the stented valve within the conduit lumen. In one embodiment, the stented valve is expanded into position using a balloon. In another embodiment, the stented valve comprises a self-expanding stent that expands radially when released from the delivery catheter. In one embodiment, the stented valve expands radially when released from a restraining sheath of the delivery catheter. In another embodiment, withdrawal of the restraining sheath deploys a plurality of barbs into a penetration configuration. In one embodiment, expansion of the self expanding stented valve sets the barbs within the wall of the prosthetic conduit or vessel. In another embodiment, the barbs are set using an inflation device deployed within the stented valve after delivery. Contact of the balloon with the head of the attachment device drives the attached barb into the wall of the conduit, thereby securing the stented valve to the conduit. Method 1200 ends at 1240. [0067] 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. 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