Source: http://www.google.com/patents/US6416537?dq=6,044,471
Timestamp: 2016-06-28 20:06:43
Document Index: 179693413

Matched Legal Cases: ['art.\n9', 'art.\n10', 'art.\n11', 'art.\n19', 'art.\n20', 'art.\n21', 'art.\n28', 'art.\n29']

Patent US6416537 - Multi-stage prosthesis - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas...http://www.google.com/patents/US6416537?utm_source=gb-gplus-sharePatent US6416537 - Multi-stage prosthesisAdvanced Patent SearchPublication numberUS6416537 B1Publication typeGrantApplication numberUS 09/604,382Publication dateJul 9, 2002Filing dateJun 27, 2000Priority dateDec 3, 1996Fee statusPaidPublication number09604382, 604382, US 6416537 B1, US 6416537B1, US-B1-6416537, US6416537 B1, US6416537B1InventorsPaul Martakos, Peter Gingras, Theodore Karwoski, Steve A. HerweckOriginal AssigneeAtrium Medical CorporationExport CitationBiBTeX, EndNote, RefManPatent Citations (27), Non-Patent Citations (1), Referenced by (72), Classifications (24), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetMulti-stage prosthesis
US 6416537 B1Abstract
What is claimed is: 1. A prosthesis for surgical implantation to replace a segment of a blood vessel, the prosthesis comprising:
a first polymer tube having an exterior surface; at least one support structure wound at a pitch about the exterior surface of the first polymer tube to form discrete, axially spaced-apart ridges on the exterior surface, the pitch being effective to direct a needle to a puncture site at an angle that inhibits needle plowing and hole enlarging; and a polymer membrane placed over the support structure; wherein the first polymer tube has a first porosity and the polymer member has a second porosity distinct from the first porosity. 2. The prosthesis of claim 1, wherein the support structure includes a metal wire.
3. The prosthesis of claim 1, wherein he support structure is a bead having a diameter less than approximately 1 millimeter.
4. The prosthesis of claim 1, wherein the support structure is a bead of PTFE.
5. The prosthesis of claim 1, wherein the support structure is a bead of solid, non-porous and unexpanded PTFE.
6. The prosthesis of claim 1, wherein the polymer membrane bonds to the first polymer tube and encloses the ridges.
7. The prosthesis of claim 6, wherein the first polymer tube, the support structure and the membrane are coalesced by heat to substantially unitize the prosthesis against delamination.
8. The prosthesis of claim 1, wherein the ridges are spaced less than approximately 5 mm apart.
9. The prosthesis of claim 1, wherein the ridges are spaced less than approximately 3 mm apart.
10. The prosthesis of claim 1, wherein the ridges are spaced approximately 1 mm to approximately 3 mm apart.
11. A tubular prosthesis comprising:
a first tubular member constructed from a polymer material and having an exterior surface; a support structure positioned about the exterior of the tubular member in a helical or circular pattern to form axially spaced-apart ridges on the exterior surface, the ridges being dimensioned and positioned with a pitch effective to trap a needle from sliding axially and thereby inhibiting tearing along the axis of the tube when the prosthesis is subject to cannulization; and a second tubular member placed over the support structure and the first tubular member; wherein the first tubular member has a first porosity and the second tubular member has a second porosity distinct from the first porosity. 12. The prosthesis of claim 11, wherein the support structure includes a metal wire.
13. The prosthesis of claim 11, wherein the support structure has a diameter less than approximately 1 millimeter.
14. The prosthesis of claim 11, wherein the support structure is a bead of PTFE.
15. The prosthesis of claim 11, wherein the support structure is a bead of solid, non-porous and unexpanded PTFE.
16. The prosthesis of claim 11, wherein the second tubular member bonds to the first tubular member and encloses the ridges.
17. The prosthesis of claim 16, wherein the first tubular member, the support structure and the second tubular member are coalesced by heat.
18. The prosthesis of claim 11, wherein the ridges are spaced less than approximately 5 mm apart.
19. The prosthesis of claim 11, wherein the ridges are spaced less than approximately 3 mm apart.
20. The prosthesis of claim 11, wherein the ridges are spaced approximately 1 mm to approximately 3 mm apart.
21. A method of forming a tubular prosthesis, the method comprising:
providing a first polymer tube having an exterior surface; winding at least one support structure at a pitch on the exterior surface of the first polymer tube in a helical or circumferential pattern to form discrete, axially spaced-apart ridges on the exterior surface, the pitch being effective to direct a needle to a puncture site at angle that inhibits needle plowing and hole enlarging; and placing an outer polymer tube over the ridges and coalescing the first polymer tube and the outer polymer tube to enclose the ridges; wherein the first polymer tube has a first porosity and the outer polymer tube has a second porosity distinct from the first porosity. 22. The method of claim 21, wherein the support structure includes a metal wire.
23. The method of claim 21, wherein the support structure has a diameter less than approximately 1 millimeter.
24. The method of claim 21, wherein the support structure is a bead of PTFE.
25. The method of claim 21, wherein the support structure is a bead of solid, non-porous and unexpanded PTFE.
26. The method of claim 21, further comprising the outer polymer tube bonding with the first polymer tube.
27. The method of claim 21, wherein the step of winding includes spacing the ridges less than approximately 5 mm apart.
28. The method of claim 21, wherein the step of winding includes spacing the ridges less than approximately 3 mm apart.
29. The method of claim 21, wherein the step of winding includes spacing the ridges approximately 1 mm to approximately 3 mm apart.
This application is a continuation-in-part application of Ser. No. 09/246,312 filed on Feb. 8, 1999, Pending, which in turn is a divisional application of Ser. No. 08/760,113 filed on Dec. 3, 1996, now U.S. Pat. No. 5,897,587. The contents of all of the aforementioned application(s) are hereby incorporated by reference.
This application relates to the commonly owned United States Patent Applications having the following titles and attorney docket numbers, which are being filed by applicant of even date herewith: VASCULAR ENDOPROSTHESIS AND METHOD, U.S. patent application Ser. No. 08/759,861 filed Dec. 3, 1996, now U.S. Pat. No. 5,925,074; PROSTHESIS WITH IN-WALL MODULATION, U.S. patent application Ser. No. 08/760,115 filed Dec. 3,1996, now U.S. Pat. No. 5,824,050; and EXPANDABLE SHIELDED VESSEL SUPPORT, U.S. patent. application Ser. No. 08/759,877 filed Dec. 3, 1996, now U.S. Pat. No. 6,010,529. It also relates to applicants' earlier U.S. Pat. Nos. 5,433,909 and 5,474,824. The foregoing patents describe methods of making extruded PTFE material having large oriented nodes, uniaxially oriented fibrils and a pore structure of oriented channels that differs at different surfaces, or that varies along the thickness dimension of the material. The aforesaid patent applications each describe constructions or methods of use for prostheses, which are further useful in the embodiments and applications of the present invention. Each of the aforementioned United States Patents and Patent Applications is hereby incorporated by reference herein in its entirety.
Conventional vascular grafts manufactured from porous polytetrafluoroethylene have limitations in surgical handling and healing. In some instances the porous grafts are wrapped with an external reinforcing film to increase radial strength. Vascular grafts may also be reinforced with an external spiral bead or ring. The reinforcing film does not provide radial support to prevent kinking and collapse during placement or during access use. Furthermore, the presence of an external bead or ring results in interference during surgical placement increasing trauma to the surrounding tissue. In addition, such grafts may be stiff and noncompliant to the natural artery.
The products of the present invention have a very broad application in medical devices, such as vascular grafts, endovascular devices, and vascular access devices. In a preferred embodiment, each radial cross-section region of the implant can be distinguished from other regions by having different pore size, pore shape, and porosity in conjunction with an intrawall circumferential support integral to the structure. Indeed, the fibril-nodal microstructure throughout the matrix may have the internodal distance, i.e. pore size, in one section at least two to twenty times that for its adjacent sections. One in vivo material has two cross-section regions. The first region, for example, has an internodal distance of the pores of the PTFE luminal surface of about 20 or 30 microns and a specific node/fibril geometry. In the next zone the internodal distance of the pores is a range from about 1 to about 10 microns and a specific node/fibril geometry, preferably 1 to 5 microns. This pore size is excellent for cell growth mediator permeability, instead of undesired encapsulation. Another embodiment of the present invention includes the luminal surface and second and third zones of material previously described whereby the third zone has a pore size range of 50 to 500 microns and a specific node/fibril geometry, preferably about 50 to 100 microns which is excellent for fibroblast tissue ingrowth, as the healing process progresses. In a further embodiment, a circumferential support having a radius of diameter from 25 to 100 microns is present within the wall structure to provide kink and compression resistance along with dialysis technique improvement.
FIGS. 1A through 1D is a schematic illustration of a process for manufacturing a tubular prosthesis in accordance with the principles of this invention.
A PTFE porous tube which can be used in the present invention may be initially produced by a method which is basically the same as the one described in U.S. Pat. Nos. 5,433,909 and 5,474,824. The method comprises the step in which a mixture of unsintered PTFE powder and a liquid lubricant is supplied into a ram extruder to extrude in a tubular form, the tube thus obtained is then stretched in the longitudinal direction, while the liquid lubricant is or is not removed from the tube; thereafter while the stretched tube is fixed to prevent shrinkage, the stretched tube is sintered by heating to a sintering temperature of 327� C. or more to fix the stretched structure.
In a porous, fibrous material, that part of the total porosity which is available to fluid flow is called the “effective porosity”. The pressure required to force a liquid into a pore is a function of pore size and geometry, liquid surface tension, and solid/liquid contact angle. Surface tension opposes the entry of any nonwetting liquid (any liquid having a contact angle with surface of the material greater than 90�) into a pore and this opposition may be overcome by external pressure.
Vascular permeability or hydraulic conductivity is related to material porosity. Water entry pressure (WVEP) is a good measuring technique in this application because it closely mimics the permeation process at the blood/prosthesis interface. WEP is defined as the pressure value necessary to push water into the pores of a synthetic tubular substrate and can be classified as: High (>400 mm Hg), Medium (200-400 mm Hg), and Low (<200 mm Hg).
As illustrated in FIGS. 1A through 1C, the process may be considered in four discrete steps. In step one (FIG. 1A), a tube 20 formed of PTFE resin is placed on a tight-fitting stainless steel forming mandrel 22. The tube 20 may be formed from PTFE resin (Fluon CD-123 obtained from ICI Americas) which has been blended with 100 grams of “Isopar H” odorless solvent (produced by Exxon Corporation) per pound of PTFE, compressed into a preform billet and extruded into a 6.0 mm I.D. and 6.8 mm O.D. tube in a ram extruder having a reduction ratio of about 200:1 in cross-sectional area from billet to extruded tube. After removal of lubricant, the extruded tube is expanded and sintered, according to the method described in the aforesaid US Patents incorporated herein for reference, under various conditions to produce material with different node/fibril structures.
In the next step (FIG. 1B), a bead of diameter less than 1 mm., for example, a 375 micron diameter PTFE bead 24 may be wrapped circumferentially in a helical manner around the tube 20. In a third step (FIG. 1C) a PTFE outer tube or wrap 30 covers the tube 20 with its helically wrapped beads. This tube 30 may be formed using PTFE resin (FLUON CD-123 obtained from ICI Americas) blended with 100 grams of “Isopar H” odorless solvent (produced by Exxon Corporation) per pound of PTFE, compressed into a preform billet and extruded into a 2.0 mm I.D. and 2.4 mm O.D. tube in a ram extruder having a reduction ratio of about 200:1 in cross-sectional area from billet to extruded tube. After removal of lubricant, the extruded tube was expanded and sintered, according to the method described in the aforesaid US Patents incorporated herein for reference, under various conditions to produce material with different node/fibril structures. This tube 30 is dilated to an 8 mm O.D. prior to placing it over the beaded tube 20.
The helical bead 24 is wrapped around tube 20 with a pitch such that the spaced apart protruding ridges 40 are spaced at a distance, such as to 1-3 mm, which is effective to trap a needle inserted into said space thereby preventing longitudinal tearing of the prosthesis when cannulized with a dialysis needle. Preferably the helical winding is wound with a pitch effective to direct the needle to a puncture site at an angle which prevents substantial plowing, hole enlarging shape deformation.
With reference now to FIGS. 2A and 2B, microphotographs at a magnification of 50�, of the cross section of a prosthesis wall of two embodiments of a product produced by the above described method are shown. With reference to FIG. 2A, the inner, or luminal, surface 46 of a prosthesis wall is formed of a PTFE material characterized by a relatively low density, and a porosity having relatively large pores interconnected by fibrils. Wrapped around that surface is a bead 42 which as above described can be formed either of a solid PTFE, or by a wire or metal core covered by PTFE. The next zone of the wall is a wrap cover 48 of PTFE which has been coalesced by heat to envelope both the inner surface 46 and the bead 42. In some embodiments the porosity of the cover 48 may be (as illustrated in FIG. 2A) a different porosity than that of the inner surface 46. Finally the outer surface of the prosthesis wall 52 may again be formed of a relatively low porosity PTFE material.
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Bard, Inc.Vascular Graft With Kink Resistance After Clamping* Cited by examinerClassifications U.S. Classification623/1.13International ClassificationA61F2/06, A61L27/50, A61L27/34, A61F2/00, A61F2/24, A61L27/16, A61F2/10, A61F2/88Cooperative ClassificationA61L27/16, A61F2/07, A61F2/2412, A61F2240/001, A61L27/507, A61F2/105, A61F2/06, A61F2002/072, A61L27/34, A61F2/88European ClassificationA61F2/07, A61L27/16, A61L27/34, A61F2/06, A61L27/50ELegal EventsDateCodeEventDescriptionDec 17, 2002CCCertificate of correctionJan 28, 2003CCCertificate of correctionJan 9, 2006FPAYFee paymentYear of fee payment: 4Apr 27, 2009ASAssignmentOwner name: RBS CITIZEN NATIONAL ASSOCIATION, NEW HAMPSHIREFree format text: SECURITY AGREEMENT;ASSIGNOR:ATRIUM MEDICAL CORPORATION;REEL/FRAME:022610/0834Effective date: 20090306Jan 11, 2010FPAYFee paymentYear of fee payment: 8Dec 30, 2013FPAYFee paymentYear of fee payment: 12RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services