Braided, branched, implantable device and processes for manufacture thereof

• US 6,652,571 B1
• Filed: 10/31/2000
• Issued: 11/25/2003
• Est. Priority Date: 01/31/2000
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: White, Bradley R., Chouinard, Paul F., Haverkost, Patrick A., Peiffer, Dennis A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US09/702,205
• Time in Patent Office: 1,120 Days
• Field of Search: 623/1.1, 623/1.13, 623/1.14, 623/1.15, 623/1.32, 623/1.35, 623/1.44, 623/1.53, 623/1.22
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/40 for making tubular braids by circulating strand supplies around braiding centre at equal distances
• CPC Class Codes: D04C 3/48 Auxiliary devices
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A braided, branching implantable device, such as a stent, a graft, or a composite stent-graft, for deployment in a lumen, the device comprising a body that branches into a plurality of legs. At least a first leg portion of each leg comprises a discrete plurality of continuous strands braided together and at least a first body portion of the body comprises at least one of said continuous strands from each discrete plurality of continuous strands braided together. Processes for fabricating the device and a method for using the device are also claimed. One fabrication process comprises braiding a first plurality of continuous strands to individually form at least a portion of a first leg; braiding at least a second plurality of continuous strands to individually form at least a portion of a second leg; and braiding at least one strand from each of the first plurality of continuous strands and the second plurality of continuous strands together to form at least a portion of the body. This process may be performed using circular braiding equipment or cartesian braiding equipment. Another process comprises the steps of creating a plurality of flat-braided strips having longitudinal edges; attaching at least one portion of one longitudinal edge of one strip to a corresponding portion of an opposite longitudinal edge of another strip; and continuing to attach selected portions of the longitudinal edges of the plurality of strips to one another until the braided, branched, implantable, tubular device is formed.

Claims

1. A branching implantable device for deployment in a lumen, the device comprising at least a graft having a body that branches into a plurality of legs, wherein at least a first leg portion of each leg comprises a discrete plurality of continuous fabric yarns braided together and at least a first body portion of the body comprises at least one of said continuous fabric yarns from each discrete plurality of continuous fabric yarns braided together, the graft having a permeability of less than or equal to 1500 ml/cm2 per minute.

2. The device of claim 1 wherein the fabric yarns comprise a material selected from the group consisting of:

polyethyleneterepthalate (PET), polyetheretherketone (PEEK), polysulfone, polytetrafluroethylene (PTFE), expanded polytetrafluroethylene (ePTFE), fluorinated ethylene propylene (FEP), polycarbonate urethane, a polyolefin, silicone, polyurethane, and a combination thereof.

3. The device of claim 1 wherein the fabric yarns comprise a polyolefin selected from the group consisting of polypropylene, polyethylene, high density polyethylene (HDPE), and a combination thereof.

4. The device of claim 1 wherein the fabric yarns have a linear density of between about 10 to 500 denier.

5. The device of claim 4 wherein the fabric yarns have a linear density of between about 40 to 225 denier.

6. The device of claim 1 wherein the graft has a thickness in a range of about 0.003 to about 0.015 inches.

7. The device of claim 1 wherein the graft has a braiding angle of approximately 110°

.

8. The device of claim 1 wherein the braided graft is coated with a polymer to reduce permeability.

9. The device of claim 1 further comprising a stent over or under which the graft is positioned to create a stent-graft combination, the stent-graft combination further comprising at least one graft membrane positioned on an inner surface of the graft or stent, an outer surface of the stent or graft, or a combination thereof.

10. The device of claim 1, wherein there is essentially no interstitial space between the braided fabric yarns.

11. The device of claim 1 wherein the device comprises a composite stent-graft in which the plurality of fabric yarns are interbraided with a plurality of structural stent filaments.

12. The device of claim 11 wherein the structural stent filaments are interbraided with the fabric yarns in a ratio between 1:

5 and 1;

30.

13. The device of claim 11 wherein the structural stent filaments are interbraided with the fabric yarns in a ratio between 1:

10 and 1;

20.

14. A branching implantable device for deployment in a lumen, the device comprising at least a graft having a body that branches into a plurality of legs, wherein at least a first leg portion of each leg comprises a discrete plurality of continuous fabric yarns braided together and at least a first body portion of the body comprises at least one of said continuous fabric yarns from each discrete plurality of continuous fabric yarns braided together, the device comprising a number of fabric yarns in a range of about 70 to about 600 yarns.

15. A branching implantable device for deployment in a lumen, the device comprising at least:

a graft having a body that branches into a plurality of legs, wherein at least a first leg portion of each leg comprises a discrete plurality of continuous fabric yarns braided together and at least a first body portion of the body comprises at least one of said continuous fabric yarns from each discrete plurality of continuous fabric yarns braided together; and

a stent comprising a stent body that branches into a plurality of stent legs wherein at least a first stent leg portion of each stent leg comprises a discrete plurality of continuous stent filaments braided together and at least a first stent body portion of the stent body comprises at least one of said continuous stent filaments from each discrete plurality of continuous stent filaments braided together;

wherein the stent and the graft are discrete components that have been joined together to form a stent-graft combination.

16. The device of claim 15 wherein the stent and graft are joined together with an adhesive.

17. The device of claim 15 wherein the stent and graft are joined together with a plurality of sutures.

18. The device of claim 15, wherein the fabric yarns comprise a material selected from the group consisting of:

polyethyleneterepthalate (PET), polyetheretherketone (PEEK), polysulfone, polytetrafluroethylene (PTFE), expanded polytetrafluroethylene (ePTFE), fluorinated ethylene propylene (FEP), polycarbonate urethane, a polyolefin, silicone, polyurethane, and a combination thereof.

19. The device of claim 15, wherein the fabric yarns comprise a polyolefin selected from the group consisting of polypropylene, polyethylene, high density polyethylene (HDPE), and a combination thereof.

20. The device of claim 15 comprising a number of fabric yarns in a range of about 70 to about 600 yarns.

21. The device of claim 15, wherein the fabric yarns have a linear density of between about 10 to 500 denier.

22. The device of claim 21, wherein the fabric yarns have a linear density of between about 40 to 225 denier.

23. The device of claim 15, wherein the graft has a thickness in a range of about 0.003 to about 0.015 inches.

24. The device of claim 15, wherein the graft has a permeability of less than or equal to 1500 ml/cm2 per minute.

25. The device of claim 15, wherein the graft has a braiding angle of approximately 110°

.

26. The device of claim 15, wherein the braided graft is coated with a polymer to reduce permeability.

27. The device of claim 15, wherein the stent-graft combination further comprises at least one graft membrane positioned on an inner surface of the graft or stent, an outer surface of the stent or graft, or a combination thereof.