Apparatus and method for deploying an implantable device within the body

• US 20060155363A1
• Filed: 09/30/2005
• Published: 07/13/2006
• Est. Priority Date: 01/10/2005
• Status: Active Grant

• Current Assignee: Taheri Laduca LLC
• Original Assignee: Taheri Laduca LLC
• Inventors: LaDuca, Robert, LaDuca, Paul
• Granted Patent: US 8,287,583 B2
• Time in Patent Office: Days
• US Class Current: 623/1.160
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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 2250/0039 differing in diameter

Abstract

The present invention provides devices and methods for fabricating and deploying an implantable device within the body. The invention is particularly suitable for delivering and deploying a stent, graft or stent graft device within a vessel or tubular structure within the body, particularly where the implant site involves two or more interconnecting vessels. The delivery and deployment system utilizes a plurality of strings which are releasably attached to the luminal ends of the implantable device.

Claims

1. An implantable stent for deployment into a vessel or tubular structure comprising:

a main lumen having a proximal end and a distal end; and

at least one side branch lumen interconnected and in fluid communication with the main lumen;

wherein at least one of the main lumen and the at least one side branch lumen is adjustable.

2. The stent of claim 1 wherein an orientation of at least one side branch lumens is adjustable relative to the main lumen.

3. The stent of claim 1 comprising two or more side branch lumens wherein the lumens are spaced axially and circumferentially relative to each other.

4. The stent of claim 1 wherein at least one of the main lumen or the at least one side branch lumen has a length, a diameter, or a shape that is adjustable.

5. The stent of claim 1 is fabricated from a single woven into a pattern of interconnected cells.

6. The stent of claim 1 wherein at least some of the cells are asymmetrical.

7. The stent of claim 1 wherein at least some of the cells have different sizes.

8. The stent of claim 1 having a configuration of the group consisting of a straight cylindrical configuration, a curved tubular configuration and a tapered hollow configuration.

9. The stent of claim 1 wherein an end of at least one of the main lumen and the at least one branch lumen is flared.

10. The stent of claim 1 further coated with at least one active ingredient for localized delivery.

11. The stent of claim 10 configured to diffuse the active ingredient at a controlled rate.

12. The stent of claim 1 comprising a coating having an uneven or roughened surface.

13. The stent of claim 1 wherein the stent has been seeded with cells in order to promote angiogenesis.

14. The stent of claim 13 further comprising a porous coating adapted to allow tissue growth.

15. The stent of claim 1 further comprising an extracellular matrix material.

16. The stent of claim 1 further comprising a sensor for monitoring a physiological parameter of a patient.

17. The stent of claim 1 further comprising a marking element to provide an indication of an orientation of the main lumen and the side branch lumens.

18. The stent of claim 1 wherein the stent is deployable by any known means of deployment.

19. The stent of claim 1 wherein the stent is deployable by detachable strings.

20. The stent of claim 19 further comprising a plurality of points along its length for receiving one or more detachable strings, whereby selective interlacing of the plurality of points provides enables the angular orientation at least side branch lumen relative to the main lumen.

21. The stent of claim 1 comprising at least two side branch lumens;

wherein each of the at least two side branch lumens has an orientation with respect to the main lumen defined by a first angle and an axial orientation with respect to the other side branch lumen defined by a second angle, and a rotational orientation with respect to the other side branch lumen defined by a third angle; and

wherein the first angle ranges from about 10°

to about 70°

, the second angle ranges from 0°

to about 170°

, and the third angle ranges from about 0°

to about 360°

.

22. The stent of claim 21 wherein one or more of the orientations may be adjusted upon delivery and placement of the branch lumens within the vessel or tubular structure.

23. The stent of claim 1 wherein a length and a diameter of the at least one side branch lumen are adjustable.

36. The system of claim 1, wherein the implant further comprises a main lumen along the length and at least one side branch lumen extending from the main lumen and having a distal end, wherein the at least one string is adapted for releasable attachment to the distal end of the at least one side branch lumen.

24. A method of fabricating an implantable device having a main lumen and at least one side branch lumen, said method comprising:

a mandrel device comprising a main mandrel and at least one side mandrel extending substantially transverse to the main mandrel, wherein each of the main mandrel and the at least one side mandrel have a plurality of pins extending there from; and

winding a length of wire around the pins of the mandrel device, wherein the wound wire forms interconnected cells, wherein the cells of the main mandrel form the main lumen of the implantable device and the cells of the at least one side mandrel form the at least one side branch lumen of the at least one side branch lumen, and wherein the cells of the main lumen are interconnected with the cells of the at least one side branch lumen.

25. The method of claim 24 further comprising:

heating the mandrel device and the wound wire to a selected temperature; and

cooling the mandrel device and the wound wire.

26. The method of claim 25 wherein the selected temperature ranges from about 480°

C. to about 520°

C.

27. The method of claim 26 wherein the selected temperature is about 490°

C.

28. The method of claim 25 wherein the cooling comprises placing the mandrel device and the wound wire in a water bath.

29. The method of claim 24, 25 or 26 further comprising removing the wound wire from the mandrel device

30. The method of claim 24 wherein the pins are selectively positionable within the mandrel device.

31. The method of claim 24 wherein the wire is made of a super elastic memory material.

32. The method of claim 31 wherein the super elastic memory material is NITINOL.

33. A system for delivering and deploying an implant within a vessel or tubular structure within the body, the implant having a distal end and a proximal end defining a length therebetween and having a diameter, the system comprising:

a first catheter configured for slidable retention of the implant therein;

at least one string adapted for releasable attachment to the implant;

a second catheter configured for removable attachment to the at least one string;

wherein the first and second catheters are in substantial axial alignment with each other upon attachment of the at least one string to the second catheter.

34. The system of claim 33 further comprising a guide wire over which both of the catheters are trackable.

35. The system of claim 34 further comprising at least a second guide wire to which an end of the implant is releasably attached.

37. A method of implanting a device to a target location within a vessel or tubular structure within the body having a main vessel and at least one side branch vessel in fluid communication with the main vessel, the method comprising:

creating first and second incisions within the body;

advancing a first catheter through the vasculature from the first incision to the second incision until a first end of the catheter is exposed from the second incision;

tethering the first catheter to a first end of the second catheter;

retracting the first catheter from the first incision until the first end of the second catheter is positioned at the target location;

advancing the device through the second catheter; and

deploying the device from the first end of the catheter at the target location.

38. The method of claim 37, wherein the tethering of the first catheter to the second catheter comprises attaching the ends of a string to the second catheter wherein the string is releasably attached to the device.

39. The method of claim 38, wherein the device comprises a main lumen having a proximal end and a distal end defining a length therebetween and at least one side branch lumen extending from the main lumen and having a distal end and defining a length, and wherein the string is releasably attached to the distal end of the at least one side branch lumen.

40. The method of claim 37, wherein the first and second incisions are made locations on the body to provide access to at least one of the innominate artery, the left carotid artery and the left subclavian artery.

41. The method of claim 40, wherein the first incision is made into the brachiocephalic artery and the second incision is made a femoral artery.