Deployment system for an endoluminal device

• US 9,662,237 B2
• Filed: 06/18/2014
• Issued: 05/30/2017
• Est. Priority Date: 01/17/2003
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Vonesh, Michael J., Cully, Edward H., Ulm, Mark J.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US14/308,152
• Publication Number:
  US 20140303711A1
• Time in Patent Office: 1,077 Days
• Field of Search: 604 9601, 604264, 606108, 606194, 606198, 623 111, 623 112, 623 113, 623 123, 623 318
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line.

Claims

1. A deployment system for a self-expanding endoluminal device, said deployment system comprising:

a catheter having an elongate body having a proximal end, an opposite distal end, a first longitudinal passage having a first longitudinal axis that is coaxial with the elongate body, and a second longitudinal passage having a second longitudinal axis that is laterally offset from the first longitudinal axis, the first and second longitudinal passages extending longitudinally between the proximal and distal ends;

a removable thin-film sheath having a sheath portion defining a substantially uninterrupted wall that surrounds and constrains at least a portion of the endoluminal device toward a delivery profile suitable for endoluminal delivery of the endoluminal device, and a deployment line portion that is continuous with the sheath portion and extends from the sheath portion and into the second longitudinal passage to facilitate axial displacement of the thin-film sheath relative to the endoluminal device which facilitates expansion of the endoluminal device from the delivery profile,

wherein a combined length of the sheath portion and deployment line portion as measured along a longitudinal dimension of the catheter remains substantially the same both before and after deployment of the device.

2. The deployment system of claim 1, wherein the sheath portion covering the endoluminal device is shortened and the deployment line portion is lengthened as the thin-film sheath is axially displaced relative to the endoluminal device during deployment.

3. The deployment system of claim 2, wherein the sheath portion is split as the thin-film sheath is axially displaced relative to the endoluminal device during deployment to facilitate conversion of the split sheath portion to the deployment line portion.

4. The deployment system of claim 3, including a splitter that splits the sheath portion as the thin-film sheath is axially displaced relative to the endoluminal device during deployment.

5. The deployment system of claim 4, wherein the splitter is disposed proximal to the endoluminal device.

6. The deployment system of claim 5, wherein the split sheath portion is gathered and forms a filament that becomes part of the deployment line portion as the thin-film sheath is axially displaced relative to the endoluminal device during deployment.

7. The deployment system of claim 1, wherein the thin-film sheath comprises a wall with a thickness of less than 0.05 mm.

8. The deployment system of claim 1, wherein the thin-film sheath comprises a continuous film that surrounds the endoluminal device in a double layered configuration.

9. The deployment system of claim k wherein one layer of the double layer is placed over the other layer and one layer moves past the other layer upon deployment.

10. A catheter assembly, said catheter assembly comprising:

a catheter having an elongate body having a proximal end, an opposite distal end, a first longitudinal passage having a first longitudinal axis that is coaxial with the elongate body, and a second longitudinal passage having a second longitudinal axis that is laterally offset from the first longitudinal axis, the first and second longitudinal passages extending longitudinally between the proximal and distal ends;

a self-expandable endoluminal device disposed at or near the distal end of the catheter; and

a removable thin-film sheath having a sheath portion defining an uninterrupted wall that surrounds and constrains at least a portion of the endoluminal device toward a delivery profile suitable for endoluminal delivery of the endoluminal device, and a deployment line portion that is continuous with the sheath portion and extends from the sheath portion and into the second longitudinal passage to facilitate axial displacement of the removable thin-film sheath relative to the endoluminal device which facilitates expansion of the endoluminal device from the delivery profile,

wherein the sheath portion converts to the deployment line portion as the removable thin-film sheath is axially displaced relative to the endoluminal device,

wherein a combined length of the sheath portion and deployment line portion as measured along a longitudinal dimension of the catheter remains substantially the same both before and after deployment of the endoluminal device.

11. The deployment system of claim 10, wherein the sheath portion is split as the removable thin-film sheath is axially displaced relative to the endoluminal device during deployment to facilitate conversion of the split sheath portion to the deployment line portion.

12. The deployment system of claim 11, including a splitter disposed proximal to the endoluminal device for splitting the removable thin-film sheath portion as the sheath is axially displaced relative to the endoluminal device during deployment.

13. The deployment system of claim 12, wherein the sheath portion comprises a continuous film that surrounds the endoluminal device in a double layered configuration.

14. The deployment system of claim 10, wherein the removable thin-film sheath is made of a polymeric material.

15. The deployment system of claim 14, wherein the polymeric material includes a fluoropolymer.

16. The deployment system of claim 15, wherein the fluoropolymer is polytetrafluoroethylene.

17. The deployment system of claim 16, wherein the polytetrafluoroethylene is porous expanded polytetrafluoroethylene.

18. The deployment system of claim 17, wherein the porous expanded polytetrafluoroethylene is in the form of a tube.

19. The deployment system of claim 18, wherein the tube has a wall with a thickness of less than 0.05 mm.

20. The deployment system of claim 10, wherein a first portion of the removable thin-film sheath substantially surrounds at least a portion of the self-expanding endoluminal device and a second portion of the removable thin-film sheath substantially covers the first portion.

21. The deployment system for a self-expanding endoluminal device of claim 20, wherein the deployment line is integral with the second portion of the removable thin-film sheath.

22. A deployment system for a self-expanding endoluminal device, said deployment system comprising:

a catheter having an elongate body having a proximal end, an opposite distal end, a first longitudinal passage having a first longitudinal axis that is coaxial with the elongate body, and a second longitudinal passage having a second longitudinal axis that is laterally offset from the first longitudinal axis, the first and second longitudinal passages extending longitudinally between the proximal and distal ends;

a splitter disposed proximal the endoluminal device that splits the sheath portion as the thin-film sheath is axially displaced relative to the endoluminal device during deployment; and

a removable thin-film sheath having a sheath portion defining a substantially uninterrupted wall that surrounds and constrains at least a portion of the endoluminal device toward a delivery profile suitable for endoluminal delivery of the endoluminal device, and a deployment line portion that is continuous with the sheath portion and extends from the sheath portion and into the second longitudinal passage to facilitate axial displacement of the thin-film sheath relative to the endoluminal device which facilitates expansion of the endoluminal device from the delivery profile,

wherein the sheath portion covering the endoluminal device is shortened and the deployment line portion is lengthened as the thin-film sheath is axially displaced, a combined length of the sheath portion and deployment line portion as measured along a longitudinal dimension of the catheter remaining substantially the same both before and after deployment of the endoluminal device, and

wherein the sheath portion is split and gathered to form a filament that becomes part of the deployment line portion as the thin-film sheath is axially displaced relative to the endoluminal device during deployment to facilitate conversion of the split sheath portion to the deployment line portion.