Apparatus and method for deploying an implantable device within the body

• US 8,128,680 B2
• Filed: 10/06/2006
• Issued: 03/06/2012
• Est. Priority Date: 01/10/2005
• Status: Active Grant

• Current Assignee: Taheri Laduca LLC
• Original Assignee: Taheri Laduca LLC
• Inventors: Arnault De La Menardiere, Brice Maxime, Alavar, Frederich Albert Lim, Laduca, Robert C., Laduca, Paul A.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US11/539,478
• Publication Number:
  US 20070167955A1
• Time in Patent Office: 1,978 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.23, 623/1.16, 623/1.35
• US Class Current: 623/1.23
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention provides systems and methods for deploying implantable devices within the body. The delivery and deployment systems include at least one catheter or an assembly of catheters for selectively positioning the lumens of the implant to within target vessels. Various deployment and attachment mechanisms are provided for selectively deploying the implants.

Claims

1. A method of implanting a device at a target site within an aortic arch adjacent at least one side branch vessel in fluid communication with the aortic arch, the device comprising a main lumen and at least one branched lumen extending laterally therefrom, the method comprising:

providing a catheter system within which the device has been operatively loaded wherein each of a proximal end and distal end of the main lumen and the free end of the at least one branched lumen is releasably attached to the catheter system;

creating an incision within the vasculature;

advancing the catheter system through the vasculature from the incision to a target site within the aortic arch;

advancing the distal end of the main lumen from a distal end of the catheter system wherein the distal end of the main lumen remains releasably attached to the system within the aortic arch;

advancing the free end of the at least one branched lumen from a distal end of the catheter system into the side branch vessel while the main lumen remains within the aortic arch and wherein the free end remains releasably attached to the catheter system wherein tension applied to the distal end of at least one side branch luminal end elongates the at least one side branch lumen during advancement into the side branch vessel and where controlling the tension allows expanding and maintaining the side branch lumen in a partially deployed state prior to releasing from the catheter system into a fully deployed state;

detaching at least one of the advanced luminal ends from the system to implant the device.

2. The method of claim 1 wherein the advanced luminal ends are retractable to within the system prior to detachment from the system.

3. The method of claim 1 wherein at least one luminal end of the device is releasably attached to the catheter system by a spring-loaded mechanism.

4. The method of claim 3 wherein the spring-loaded mechanism comprises a plurality of extensions and a receptacle for engaging the extensions, wherein the plurality of extensions are biased to be unengaged with the receptacle.

5. The method of claim 4, wherein the luminal ends comprise apices and the system is configured to releasably capture the apices between the extensions and the receptacle.

6. The method of claim 1, wherein at least one luminal end of the device is releasably attached to the catheter system by at least one string.

7. The method of claim 1, where the side branch vessel is selected from the group consisting of an innominate artery, a common carotid artery, and a subclavian artery.

8. A method of implanting a device at a target site within the body having a main vessel and at least one laterally extending side branch vessel in fluid communication with the main vessel, where the device includes a main lumen and at least one side-branch lumen extending therefrom, the method comprising:

providing a catheter system within which the device is operatively loaded wherein each of a proximal end and distal end of the main lumen and the free end of the at least one branched lumen is releasably attached to the catheter system;

creating an incision within the vasculature;

advancing the catheter system through the vasculature from the incision to a target site within the main vessel;

advancing the distal end of the main lumen from a distal end of the catheter system wherein the distal end of the main lumen remains releasably attached to the system within the main vessel;

advancing the free end of the at least one branched lumen from a distal end of the catheter system from the main vessel and adjacent to the main lumen laterally into the side branch vessel while the main lumen remains within the main vessel and wherein the free end remains releasably attached to the system, wherein tension applied to the distal end of at least one side branch luminal end elongates the at least one side branch lumen during advancement into the side branch vessel and where controlling the tension allows expanding and maintaining the side branch lumen in a partially deployed state prior to releasing from the catheter system into a fully deployed state; and

detaching at least one of the advanced lumenal ends from the system to implant the device.

9. The method of claim 8, wherein the advanced luminal ends are retractable to within the system prior to detachment from the system.

10. The method of claim 8, wherein at least one luminal end of the device is releasably attached to the catheter system by a spring-loaded mechanism.

11. The method of claim 10, wherein the spring-loaded mechanism comprises a plurality of extensions and a receptacle for engaging the extensions, wherein the plurality of extensions are biased to be unengaged with the receptacle.

12. The method of claim 10, wherein the luminal ends comprise apices and the system is configured to releasably capture the apices between the extensions and the receptacle.

13. The method of claim 8, wherein at least one luminal end of the device is releasably attached to the catheter system by at least one string.

14. The method of claim 8, where the main vessel comprises an aortic arch and where the at least one side branch vessels comprise a vessel selected from the group consisting of an innominate artery, a common carotid artery, and a subclavian artery.

15. The method of claim 8, where the main vessel comprises an infrarenal aorta and where the at least one side branch vessels comprise a renal artery.

16. The method of claim 8, where detaching at least one of the advanced lumen ends comprises first expanding the main lumen in the main vessel while the at least one side-branch lumen remains in a stretched state.

17. The method of claim 8, where advancing the free end of the at least one branched lumen comprises first positioning the main lumen of the device in the main vessel while in a stretched condition and subsequently positioning at least one side-branch lumen extending from the main lumen of the device in the at least one side branch vessel while in a stretched or tensioned state.

18. The method of claim 8, wherein the device comprises a wire stent structure where the side branch lumen is adjustable relative to the main lumen until the device expands against the main branch vessel and side vessel.

19. The method of claim 8, wherein the device comprises a wire stent structure where an angular orientation of the side branch lumen is adjustable on the device until the device expands against the main branch vessel and side vessel.

20. The method of claim 8, further comprising maintaining continuous blood flow around the implantable device during placement.

21. The method of claim 8, further comprising repositioning the device before fully detaching at least one of the advanced lumenal ends from the system to implant the device.

22. A method of implanting a device at a target site within the body having a main vessel and at least one laterally extending side branch vessel in fluid communication with the main vessel, where the device includes a main lumen and at least one side-branch lumen laterally extending therefrom, the method comprising:

providing a catheter system within which the device is operatively loaded wherein each of a proximal end and distal end of the main lumen and the free end of the at least one side-branch lumen is releasably attached to the catheter system;

creating an incision within the vasculature;

advancing the catheter system through the vasculature from the incision to a target site within the main vessel;

advancing the distal end of the main lumen from a distal end of the catheter system wherein the distal end of the main lumen remains releasably attached to the system within the main vessel;

deflecting the free end of the at least one side-branch lumen from a distal end of the catheter system from the main vessel and adjacent to the main lumen into the side branch vessel while the main lumen remains within the main vessel where the ability of the device to adjust location and position of the main and side branch lumens allows the side branch lumen to accommodate the laterally extending side branch vessel and wherein the free end remains releasably attached to the system;

controlling tension applied to the distal end of at least one side branch luminal end to elongate the at least one side branch lumen during insertion into the side branch vessel and where controlling the tension allows expanding and maintaining the side branch lumen in a partially deployed state prior to releasing from the catheter system into a fully deployed state; and

detaching at least one of the advanced lumenal ends from the system to implant the device.

23. The method of claim 22, wherein the advanced luminal ends are retractable to within the system prior to detachment from the system.

24. The method of claim 22, wherein at least one luminal end of the device is releasably attached to the catheter system by a spring-loaded mechanism.

25. The method of claim 24, wherein the spring-loaded mechanism comprises a plurality of extensions and a receptacle for engaging the extensions, wherein the plurality of extensions are biased to be unengaged with the receptacle.

26. The method of claim 24, wherein the luminal ends comprise apices and the system is configured to releasably capture the apices between the extensions and the receptacle.

27. The method of claim 22, wherein at least one luminal end of the device is releasably attached to the catheter system by at least one string.

28. The method of claim 22, where the main vessel comprises an aortic arch and where the at least one side branch vessels comprise a vessel selected from the group consisting of an innominate artery, a common carotid artery, and a subclavian artery.

29. The method of claim 22, where the main vessel comprises an infrarenal aorta and where the at least one side branch vessels comprise a renal artery.

30. The method of claim 22, where detaching at least one of the advanced lumen ends comprises first expanding the main lumen in the main vessel while the at least one side-branch lumen remains in a stretched state.

31. The method of claim 22, where advancing the free end of the at least one branched lumen comprises first positioning the main lumen of the device in the main vessel while in a stretched condition and subsequently positioning at least one side-branch lumen extending from the main lumen of the device in the at least one side branch vessel while in a stretched or tensioned state.

32. The method of claim 22, further comprising maintaining continuous blood flow around the implantable device during placement.

33. The method of claim 22, further comprising repositioning the device before fully detaching at least one of the advanced lumenal ends from the system to implant the device.