Endolumenal prosthesis delivery assembly and method of use

• US 6,733,519 B2
• Filed: 11/28/2001
• Issued: 05/11/2004
• Est. Priority Date: 04/07/1999
• Status: Active Grant

• Current Assignee: Ave Medtronic
• Original Assignee: Ave Medtronic
• Inventors: Brooks, Dennis L., Lashinski, Robert D., Swanson, Vance E.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/994,663
• Publication Number:
  US 20020035393A1
• Time in Patent Office: 895 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.36, 606/192, 606/194, 606/198, 606/108, 604/96.01, 604/101.01
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An endolumenal prosthesis delivery assembly includes an endolumenal prosthesis which is delivered to a desired location within a body lumen by used of first and second delivery members. The first delivery member has a prosthesis coupler that is adapted to removeably engage the prosthesis during delivery to the desired location and to release the prosthesis and implant it at the desired location. The second delivery member has an anchor on its distal end portion which is adapted to secure the second delivery member within the body lumen distally of the desired location for stenting. Once the second delivery member is anchored, the first delivery member is slideably advanced over the second delivery member until the prosthesis is positioned at the desired location. The anchor along the second delivery member according to this assembly is either an expandable member, such as a balloon, or is otherwise adapted to engage the body lumen wall, such as by use of suction or other mechanical means. An expansion member on the first delivery member, such as provided at the prosthesis coupler, expands the prosthesis to engage the body lumen wall.

Claims

1. An endolumenal prosthesis delivery assembly for implanting an endolumenal prosthesis within a body lumen in a mammalian body, comprising:

an endolumenal prosthesis which is adapted to be implanted within the body lumen;

a first delivery member with a proximal end portion and a distal end portion having a prosthesis coupler which is adapted to releasably engage the endolumenal prosthesis; and

a second delivery member with a proximal end portion, an elongated body, a distal end portion, and an anchor which is located along the distal end portion of the second delivery member and which is adapted to secure the distal end portion of the second delivery member within the body lumen,

the distal end portion of the first delivery member being further adapted to slideably engage and track along the second delivery member including said anchor such that the endolumenal prosthesis when engaged to the prosthesis coupler may be positioned along and over the anchor of the second delivery member wherein a diameter of the elongated body and the anchor are approximately equal.

2. The endolumenal prosthesis delivery assembly of claim 1,

the anchor being adjustable from a first position, which is adapted to be delivered within the body lumen, to a second position, which is adapted to be secured within the body lumen.

3. The endolumenal prosthesis delivery assembly of claim 2, wherein the body lumen is formed at least in part by a body lumen wall, and

the anchor further comprising an expandable member which is coupled to an expansion member and which is adjustable with the expansion member from the first position, which is characterized by a radially collapsed condition that is adapted to be delivered within the body lumen, to the second position, which is characterized by a radially expanded condition that is adapted to radially engage the body lumen wall to thereby secure the anchor within the body lumen.

4. The endolumenal prosthesis delivery assembly of claim 3,

the expandable member further comprising an inflatable balloon;

and

the expansion member further comprising an inflation lumen which is fluidly coupled to the inflatable balloon and which is also adapted to fluidly couple to a pressurizeable fluid source.

5. The endolumenal prosthesis delivery assembly of claim 4, wherein the inflatable balloon exhibits at least a two-hundred percent elastic expansion when pressurized by a pressurizeable fluid source to a pressure of about three to five atmospheres.

6. The endolumenal prosthesis delivery assembly of claim 4, wherein the first position the inflatable balloon has an outer profile which is less than about 0.025 inches and wherein the second position the inflatable balloon has an outer profile which is greater than about 0.079 inches.

7. The endolumenal prosthesis delivery assembly of claim 4, wherein the inflatable balloon is constructed of a material selected from the group of materials consisting of polyurethane, latex rubber, silicone, and combinations and blends thereof.

8. The endolumenal prosthesis delivery assembly of claim 2, wherein the first position the distal end portion of the second delivery member has an outer profile which is less than about 0.025 inches.

9. The endolumenal prosthesis delivery assembly of claim 8, wherein the second position the distal end portion of the second delivery member has an outer profile which is greater than about 0.079 inches.

10. The endolumenal prosthesis delivery assembly of claim 1, the second delivery member further comprising a distal tip which is located distally of the anchor, which includes a coil coupled thereto, and which is adapted to have a shape which is steerable within the body lumen by torquing the proximal end portion of the second delivery member.

11. The endolumenal prosthesis delivery assembly of claim 10,

the anchor further comprising an inflatable balloon;

the second delivery member further comprising a metal hypotube which is fluidly coupled to the inflatable balloon and which is also adapted to fluidly couple with a pressurizeable fluid source; and

the proximal end portion of the second delivery member further comprising a tubular member which forms at least a portion of the inflation lumen, the proximal end portion of the second delivery member further being torquable and torsionally coupled to the shaped, radiopaque distal tip.

12. The endolumenal prosthesis delivery assembly of claim 1,

the first delivery member further comprising a lumen which extends between and communicates externally of the first delivery member through a distal port and a proximal port, the distal port being located along the first delivery member distally of the endolumenal prosthesis and the proximal port being located along the first delivery member proximally of the endolumenal prosthesis, the lumen further being adapted to slideably engage and track the second delivery member at least proximally of the anchor.

13. The endolumenal prosthesis delivery assembly of claim 12,

the anchor being adjustable from a first position, which is adapted to slideably engage the lumen through the proximal port and to advance distally of the distal port to be delivered within the body lumen, to a second position, which is adapted to be secured within the body lumen.

14. The endolumenal prosthesis delivery assembly of claim 12,

the lumen further comprising an inner diameter;

and

the anchor in the first position further comprising an outer diameter which is larger than the inner diameter of the lumen,

the second delivery member being adapted to slideably engage the lumen by backloading the proximal end portion of the second delivery member through the distal port, proximally through the lumen, and out of the proximal port, such that the distal end portion of the first delivery member is further adapted to advance and track over the distal end portion of the second delivery member proximally of the anchor.

15. The endolumenal prosthesis delivery assembly of claim 14,

the anchor further comprising an inflatable balloon;

the proximal end portion of the second delivery member further comprising an inflation lumen which is fluidly coupled to the inflatable balloon; and

further comprising a removeable coupler which is adapted to removably engage the proximal end portion of the second delivery member,

whereby engaging the removeable coupler to the proximal end portion of the second delivery member the inflation lumen is adapted to fluidly couple to a pressurizeable fluid source, and whereby removing the removeable coupler from the proximal end portion of the second delivery member the second delivery member is adapted to be backloaded through the distal port, proximally through the lumen, and out of the proximal port of the first delivery member.

16. The endolumenal prosthesis delivery assembly of claim 1,

the endolumenal prosthesis further comprising an endolumenal stent which forms an interior stent passageway, the stent being adjustable from a radially collapsed condition with a collapsed outer diameter to a radially expanded condition with an expanded outer diameter that is larger than the collapsed outer diameter and that is also adapted to radially engage the body lumen wall;

and

the prosthesis coupler further comprising an expansion member which is adapted to adjust the endolumenal stent from the radially collapsed condition to the radially expanded condition.

17. The endolumenal prosthesis delivery assembly of claim 16, wherein the endolumenal stent is a balloon expandable stent, and wherein the expansion member further comprises an expandable member which is engaged within the stent passageway and is radially expandable and thereby adapted to force the endolumenal stent from the radially collapsed condition to the radially expanded condition.

18. The endolumenal prosthesis delivery assembly of claim 17, wherein the expandable member is an inflatable balloon, and wherein the first delivery member further comprises an inflation lumen which is fluidly coupled to the inflatable balloon and is also adapted to couple to a pressurizeable fluid source.

19. The endolumenal prosthesis delivery assembly of claim 16, wherein the endolumenal stent is a self-expanding stent,

the expansion member further comprising a delivery sheath with an inner diameter which approximates the collapsed outer diameter of the endolumenal stent and which is adjustable from a confining position to a releasing position,

wherein the confining position the endolumenal stent is in the radially collapsed condition and is coaxially contained and compressed against an outward radial bias within the delivery sheath, and

wherein the releasing position the endolumenal stent is released from within the delivery sheath and is allowed to thereby expand to the radially expanded condition.

20. The endolumenal prosthesis delivery assembly of claim 16, wherein the endolumenal prosthesis further comprises a graft member which is engaged to the endolumenal stent to form a stent-graft prosthesis.

21. The endolumenal prosthesis delivery assembly of claim 1,

the anchor further comprising a suction port which is adapted to engage the body lumen wall;

and

the second delivery member further comprising a suction lumen which is adapted to fluidly couple the suction port to a vacuum source such that the anchor is adapted to be secured to the body lumen wall with suction at the suction port and from the vacuum source.

22. The endolumenal prosthesis delivery assembly of claim 21, further comprising a vacuum source adapted to couple to the suction lumen.

23. A lumenal recanalization kit for recanalizing and maintaining lumenal patency in a body lumen having a stenosed portion, comprising:

a recanalization device assembly with a recanalization member that is adapted to be delivered into and to recanalize the stenosed portion of the lumen;

an endolumenal prosthesis which is adapted to be delivered into and implanted within the stenosed portion and to maintain patency of the body lumen after recanalization with the recanalization member; and

an endolumenal prosthesis delivery assembly comprising

a first delivery member with a proximal end portion and a distal end portion having a prosthesis coupler which is adapted to releasably engage the endolumenal prosthesis, and

a second delivery member with a proximal end portion, an elongated body, a distal end portion, and an anchor located along the distal end portion of the second delivery member and which is adapted to secure the distal end portion of the second delivery member within the body lumen distally of the stenosed portion,

the distal end portion of the first delivery member being adapted to slideably engage and track along the second delivery member such that the endolumenal prosthesis when engaged to the prosthesis coupler may be positioned along and over the anchor of the second delivery member wherein the diameter of elongated body and the anchor are approximately equal;

the endolumenal prosthesis delivery assembly being further adapted to deliver and implant the endolumenal prosthesis within the stenosed portion after the stenosed portion is recanalized with the recanalization device assembly.

24. The lumenal recanalization kit of claim 23,

the recanalization member further comprising an angioplasty catheter with a balloon which is adapted to dilate the stenosed portion to thereby recanalize the body lumen.

25. The lumenal recanalization kit of claim 23,

the recanalization member further comprising an atherectomy catheter with a working member that is adapted to ablate and remove an occlusive component of the stenosed portion to thereby recanalize the body lumen.

26. The lumenal recanalization kit of claim 23, the recanalization device assembly further comprising a guidewire with a proximal end portion and a distal end portion which is adapted to be subselectively advanced within the body lumen along the stenosed portion by remote manipulation of the proximal end portion of the guidewire in a percutaneous translumenal procedure.

27. The lumenal recanalization kit of claim 23,

the anchor further comprising an expandable balloon;

the second delivery member further comprising a metal hypotube fluidly coupled to the balloon; and

the kit further comprising a pressurizeable fluid source adapted to couple to the inflation lumen and to inflate the balloon.

28. The lumenal recanalization kit of claim 23,

the prosthesis coupler further comprising an expandable balloon;

the first delivery member further comprising an inflation lumen fluidly coupled to the balloon; and

the kit further comprising a pressurizeable fluid source adapted to couple to the inflation lumen and to inflate the balloon.

29. An endolumenal delivery assembly for treating a stenosed portion of a body lumen, comprising:

a first delivery member with a proximal end portion and a distal end portion, the distal end portion having means for treating the stenosed portion of the body lumen; and

a second delivery member with a proximal end portion, an elongated body, a distal end portion, and an anchor which is located along the distal end portion of the second delivery member and which is adapted to secure the distal end portion of the second delivery member within the body lumen,

the distal end portion of the first delivery member being further adapted to slideably engage and track along the second delivery member including said anchor such that the means on the distal end of the first delivery member may be positioned along and over the anchor of the second delivery member wherein a diameter of the elongated body and the anchor are approximately equal.