Endoluminal prosthesis with fiber matrix

• US 10,154,918 B2
• Filed: 12/20/2013
• Issued: 12/18/2018
• Est. Priority Date: 12/28/2012
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Haselby, Kenneth A., Havel, William J., Hadley, Rick, Milner, Keith R., Roeder, Blayne A., Sherman, Sara M.
• Primary Examiner(s): Lynch, Robert
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US14/136,677
• Publication Number:
  US 20140188212A1
• Time in Patent Office: 1,824 Days
• Field of Search: 623 115, 623 113, 623 139, 623 11, 623 144, 623 237
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: D01D 5/003 the material being a polymer solution or dispersion D01D5/0053 takes precedence
• CPC Class Codes: D01D 5/0084 Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses

Abstract

An expandable endoluminal prosthesis may include a graft body and a support structure attached to the graft body. The graft body may include a tubular body of nonwoven electrospun fibers disposed about a longitudinal axis. A first fiber matrix segment may be attached to and extend in a transverse direction along the tubular body. A second fiber matrix segment may be attached to and extend in a longitudinal direction along the tubular body.

Claims

1. An expandable endoluminal prosthesis comprising:

a graft body and a support structure attached to the graft body, the graft body comprising;

a tubular body of nonwoven electrospun fibers disposed about a longitudinal axis, wherein the tubular body comprises an inner layer of nonwoven electrospun fibers and an outer layer of nonwoven electrospun fibers;

a first fiber matrix comprising a plurality of discrete circumferentially wound filaments attached to the tubular body and extending circumferentially around the tubular body; and

a second fiber matrix comprising a plurality of discrete longitudinally extending filaments attached to the tubular body and extending in a longitudinally along the tubular body

wherein each of the first fiber matrix and the second fiber matrix are disposed along an inner surface of the outer layer of the nonwoven electrospun fibers such that the first fiber matrix and the second fiber matrix are encapsulated between the inner layer and the outer layer of nonwoven electrospun fiber.

2. The prosthesis of claim 1, wherein each of the first fiber matrix and the second fiber matrix comprises a filamentary member.

3. The prosthesis of claim 1, wherein the support structure is at least partially encapsulated between the inner layer and the outer layer.

4. The prosthesis of claim 3, wherein the support structure comprises a plurality of support structures spaced from one another along a length of the graft body, and at least one of the plurality of support structures is encapsulated between the inner layer and the outer layer.

5. The prosthesis of claim 1, wherein the first fiber matrix is longitudinally shorter than the graft body, a longitudinal portion of the graft body comprising the first fiber matrix comprises an attachment site, and the support structure is attached to the first fiber matrix at the attachment site to attach the support structure to the graft body.

6. The prosthesis of claim 5, wherein the first fiber matrix comprises a color that is different than a color of the tubular body to aid in identification of the attachment site.

7. The prosthesis of claim 1, wherein the first fiber matrix comprises a plurality of turns extending angularly around the longitudinal axis, and the second matrix extends less than about 360 degrees angularly around the longitudinal axis.

8. The prosthesis of claim 1, wherein the first fiber matrix and the second fiber matrix are formed from two or more discrete filamentary members.

17. A method for preparing an endoluminal prosthesis of claim 1, the method comprising:

providing an electrospinning apparatus comprising an orifice and a mandrel;

generating an electric potential between the orifice and the mandrel;

forming a first layer of nonwoven fibers on an outer surface of the mandrel by electrospinning a solution from the orifice onto the outer surface of the mandrel;

positioning a first fiber matrix comprising a plurality of discrete filaments over the first layer of fibers, the first fiber matrix having fibers extending transverse to a longitudinal axis of the first layer of nonwoven fibers;

positioning a second fiber matrix comprising a plurality of discrete filaments over the first layer of fibers, the second fiber matrix having fibers extending in a longitudinal direction and substantially parallel to the longitudinal axis of the first layer of nonwoven fibers;

positioning an expandable support structure over the first layer of nonwoven fibers; and

forming a second layer of nonwoven fibers over the first fiber matrix, the second fiber matrix, and the support structure by electrospinning the solution from the orifice,

whereby each of the first fiber matrix, the second fiber matrix, and the support structure are disposed along an inner surface of the second layer of nonwoven fibers such that the first fiber matrix, the second fiber matrix, and the support structure are encapsulated within a covering formed by the first layer of nonwoven fibers and the second layer of nonwoven fibers.

9. An expandable endoluminal prosthesis comprising:

a graft body and a support structure attached to the graft body, the graft body comprising;

a tubular body of nonwoven electrospun fibers disposed about a longitudinal axis, wherein the tubular body comprises an inner layer of nonwoven electrospun fibers and an outer layer of nonwoven electrospun fibers;

a first fiber matrix attached to the tubular body and having fibers that extend circumferentially around the tubular body; and

a second fiber matrix attached to the tubular body and having fibers that extend in a longitudinally along the tubular body,

wherein each of the first fiber matrix and the second fiber matrix are disposed along an inner surface of the outer layer of the nonwoven electrospun fibers such that the first fiber matrix and the second fiber matrix are encapsulated between the inner layer and the outer layer of nonwoven electrospun fibers,

wherein the first fiber matrix is longitudinally shorter than the graft body, a longitudinal portion of the graft body comprising the first fiber matrix comprises an attachment site, and the support structure is attached to the first fiber matrix at the attachment site to attach the support structure to the graft body, and

wherein the attachment site comprises a suture zone, and the support structure is sutured to the first fiber matrix to attach the support structure to the graft body.

10. An expandable endoluminal prosthesis comprising:

a graft body and a support structure attached to the graft body, the graft body comprising;

a tubular body of nonwoven electrospun fibers disposed about a longitudinal axis, wherein the tubular body comprises an inner layer of nonwoven electrospun fibers and an outer layer of nonwoven electrospun fibers;

a first fiber matrix attached to the tubular body and having fibers that extend circumferentially around the tubular body; and

a second fiber matrix attached to the tubular body and having fibers that extend in a longitudinally along the tubular body,

wherein each of the first fiber matrix and the second fiber matrix are disposed along an inner surface of the outer layer of the nonwoven electrospun fibers such that the first fiber matrix and the second fiber matrix are encapsulated between the inner layer and the outer layer of nonwoven electrospun fibers, and

wherein at least one of the first fiber matrix and the second fiber matrix comprises a loop point comprising a loop of filamentary material extending away from the tubular body.

11. The prosthesis of claim 10, wherein the support structure is sutured to the loop point to attach the support structure to the graft body.

12. The prosthesis of claim 10, wherein a portion of the support structure is received within the loop point to attach the support structure to the graft body.

13. An expandable endoluminal prosthesis comprising:

a graft body and an expandable support structure attached to the graft body, the graft body comprising;

a tubular body of nonwoven electrospun fibers disposed about a longitudinal axis, wherein the tubular body comprises an inner layer of nonwoven electrospun fibers and an outer layer of nonwoven electrospun fibers;

a transverse fiber matrix comprising a plurality of discrete circumferentially wound filaments at least partially encapsulated within the tubular body and having fibers extending around a circumference of the tubular body; and

a longitudinal fiber matrix comprising a plurality of discrete longitudinally extending filaments at least partially encapsulated within the tubular body and having fibers extending primarily longitudinally along the tubular body;

wherein the support structure is attached to at least one of the transverse fiber matrix and the longitudinal fiber matrix to attach the support structure to the graft body, and

wherein each of the transverse fiber matrix, the longitudinal fiber matrix, and the support structure are disposed along an inner surface of the outer layer of nonwoven electrospun fibers such that the transverse fiber matrix, the longitudinal fiber matrix, and the support structure are encapsulated between the inner layer and the outer layer of nonwoven electrospun fibers.

14. The prosthesis of claim 13, wherein the transverse fiber matrix is longitudinally shorter than the graft body.

15. The prosthesis of claim 14, wherein the transverse fiber matrix comprises a plurality of transverse fiber matrices spaced from one another along a length of the graft body.

16. The prosthesis of claim 13, wherein the longitudinal fiber matrix comprises a plurality of longitudinal fiber matrices spaced from one another around a circumference of the graft body.