Radially expandable body implantable device

• US 5,496,277 A
• Filed: 11/22/1994
• Issued: 03/05/1996
• Est. Priority Date: 04/12/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Porter, Christopher H., Termin, Paul L.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/343,725
• Time in Patent Office: 469 Days
• Field of Search: 623/1, 623/11, 623/12, 606/159, 606/180, 606/191, 606/194, 128/642, 128/784-786, 604/96, 604/104-109, 604/174, 604/175
• US Class Current: 604/104
• 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 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

An open weave fixation device is secured to a distal end region of a catheter or other diagnostic or treatment device, for either temporarily or permanently fixing the device within a body cavity. In one approach, the fixation element is constructed of braided, helically wound filaments of resilient stainless steel. A sheath surrounds the catheter and fixation element to elastically deform the element into a reduced radius configuration to facilitate insertion and deployment. With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter. In all alternative arrangement, a dilatation balloon surrounds a catheter near its distal end, and in turn is surrounded by a plastically deformable fixation element. Following desired positioning, the balloon is dilated to permanently deform the fixation element into contact with body tissue. In either case, the fixation element can be mounted at its distal end, its proximal end or medially, depending upon the particular treatment and the expected duration of fixation. Another approach employs a recovery metal in the fixation element.

Claims

1. A body implantable device, including:

a flexible member of open weave construction, having a first end and a second end, and elastically compressible into a radially compressed state in which the flexible member has a first diameter substantially over its entire length; and

a substantially rigid retaining element secured to the flexible member proximate the second end, for maintaining the flexible member in the radially compressed state along a second region that includes the second end, while allowing a remainder of the flexible member to radially self-expand under an elastic restoring force, thereby to define along the flexible member a first region including the first end, the second region, and an intermediate region between the first region and the second region;

wherein the flexible member is adapted for positioning within a body cavity at a predetermined location through the radial self-expansion of the first region into an engagement with a wall segment of the body cavity, with the intermediate region allowing the passage of fluid through the body cavity due to its open weave construction.

2. The body implantable device of claim 1 wherein:

said flexible member is tubular and constructed of helical, braided strands of a biocompatible material.

3. The device of claim 2 wherein:

said biocompatible material is stainless steel.

4. The device of claim 2 wherein:

said biocompatible material is a plastic.

5. The device of claim 2 wherein:

said retaining element comprises a ring surrounding said braided strands and maintaining the braided strands in close proximity to one another along the second region.

6. The device of claim 1 wherein:

said retaining element comprises a substantially rigid ring having a ring diameter substantially equal to said first diameter.

7. The device of claim 1 further including:

a deployment means operatively associated with the flexible member, for delivering the flexible member in said radially compressed state as the flexible member is inserted to a selective positioning thereof at the predetermined location within the body cavity, said deployment means including a restraining means for elastically radially compressing the first region and the intermediate region of the flexible member and cooperating with the retaining element to maintain the flexible member in the radially compressed state against the elastic restoring force, said restraining means being controllable to allow radial self-expansion of the flexible member, over said first region, into surface engagement with the tissue wall segment to secure the flexible member at the predetermined location.

8. The device of claim 7 wherein:

said restraining means comprises a sheath surrounding the flexible member and movable relative to the flexible member for retracting the sheath to allow the flexible member to radially self-expand under said restoring force, and a means for maintaining the flexible member at said predetermined location while retracting the sheath.

9. The device of claim 8 wherein:

said body cavity is a blood vessel.

10. The device of claim 1 wherein:

said first and second ends are, respectively, proximal and distal ends of the flexible member.

11. The device of claim 1 wherein:

the radial self-expansion of the first region secures the flexible member within the body cavity at said predetermined location.

12. An apparatus for fixation in a body cavity, including:

a flexible member of open weave construction, having a first end and a second end, and elastically compressible into a radially compressed state in which the flexible member over substantially its entire length has a first diameter;

a substantially rigid retaining element secured to the flexible member proximate the second end, for maintaining the flexible member at said first diameter along a second region that includes the second end, while permitting a remainder of the flexible member to radially self-expand responsive to an elastic restoring force, thereby to define along the flexible member a first region including the first end, the second region, and an intermediate region between the first region and the second region; and

a deployment means operatively associated with the flexible member for delivering the flexible member in the radially compressed state to selectively position the flexible member at a predetermined location within a body cavity, said deployment means including a restraining means for elastically deforming the flexible member into the radially compressed state and cooperating with the retaining element to maintain the flexible member in the radially compressed state against the elastic restoring force, said restraining means being controllable to allow a radial self-expansion of the first region of the flexible member into a surface engagement with a wall segment of the body cavity at the predetermined location, with the retaining element maintaining the second region at the first diameter; and

wherein the intermediate region of the flexible member allows passage of fluid through the body cavity due to its open weave construction.

13. The apparatus of claim 12 wherein:

said retaining element comprises a ring surrounding the flexible member at the second region.

14. The apparatus of claim 13 wherein:

said ring is constructed of stainless steel, and has an outer diameter substantially equal to said first diameter.

15. The apparatus of claim 12 wherein:

the flexible member is tubular and constructed of helical, braided strands of a biocompatible material.

16. The apparatus of claim 15 wherein:

the biocompatible material is stainless steel.

17. The apparatus of claim 12 wherein:

the restraining means comprises a sheath adapted for surrounding the flexible member to maintain the flexible member in the radially compressed state, and movable relative to the flexible member for retraction of the sheath, thus to allow the flexible member to radially self-expand under the restoring force.

18. The apparatus of claim 17 wherein:

said deployment means further includes a catheter having a catheter distal end, wherein the retaining element is secured with respect to the catheter distal end, thus to secure the second end of the flexible member with respect to the catheter, said catheter being surrounded by the sheath and adapted for maintaining the flexible member at the predetermined location during retraction of the sheath.

19. The apparatus of claim 12 wherein:

the deployment means further includes a catheter having a catheter distal end, and the retaining element is secured with respect to the catheter distal end, thus to secure the flexible member with respect to the catheter.

20. The apparatus of claim 12 wherein:

said first and second ends are, respectively, proximal and distal ends of the flexible member.

21. The apparatus of claim 12 wherein:

the radial self-expansion of the first region secures the flexible member within the body cavity at said predetermined location.