Radially expandable fixation member constructed of recovery metal

• US 5,378,239 A
• Filed: 06/22/1993
• Issued: 01/03/1995
• 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: Termin, Paul L., Porter, Christopher H.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/080,749
• Time in Patent Office: 560 Days
• Field of Search: 623/1, 623/1.1, 623/12, 128/642, 604/104-109, 604/174, 604/175, 604/280, 604/281, 606/159, 606/191, 606/194, 606/198, 607/126, 607/127
• 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 With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter.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 an 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. An apparatus for fixation in a body cavity, including:

an elongate bodily insertable device having a proximal end region and a distal end region;

a fixation element at the distal end region of the device, said fixation element being constructed of a recovery metal initially set in a radially expanded configuration in which the fixation element has a fixation diameter, and then plastically deformed into a delivery configuration in which the fixation element has a delivery diameter substantially less than the fixation diameter;

wherein said device is bodily insertable to selectively position the fixation element at a predetermined location within a body cavity with the fixation element in the delivery configuration; and

said fixation element, responsive to being heated, reverts to the fixation configuration thereby radially expanding into a surface engagement with a tissue wall segment defining said cavity at a predetermined location, to secure the fixation element to the wall segment and thus substantially fix the distal region of the device within the body cavity; and

wherein said device comprises a retrieval filament constructed of the recovery metal.

2. The apparatus of claim 1 wherein:

said fixation element comprises means for contacting the tissue wall segment over substantially its entire length upon expansion into said surface engagement

3. The apparatus of claim 1 wherein:

said fixation element comprises means for at least slightly elastically deforming the tissue wall segment when in said surface engagement.

4. The apparatus of claim 1 further including:

a means for removing the fixation element from the predetermined location, following said radial expansion into surface engagement with the tissue wall segment.

5. The apparatus of claim 1 wherein:

said fixation element when in the radially expanded configuration, is a helix.

6. The apparatus of claim 5 wherein:

said helix has a substantially uniform pitch.

7. The apparatus of claim 5 wherein:

said helix is substantially elastic.

8. The apparatus of claim 1 wherein:

said fixation element, when deformed into the delivery configuration, is substantially linear.

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

an elongate bodily insertable device having a proximal end region and a distal end region;

a fixation element at the distal end region of the device, said fixation element being constructed of a recovery metal initially set in a radially expanded configuration in which the fixation element has a fixation diameter, and then plastically deformed into a delivery configuration in which the fixation element has a delivery diameter substantially less than the fixation diameter;

wherein said device is bodily insertable to selectively position the fixation element at a predetermined location within a body cavity with the fixation element in the delivery configuration; and

said fixation element, responsive to being heated, reverts to the fixation configuration thereby radially expanding into a surface engagement with a tissue wall segment defining said cavity at a predetermined location, to secure the fixation element to the wall segment and thus substantially fix the distal region of the device within the body cavity; and

a removing means for removing the fixation element from the predetermined location, following said radial expansion into surface engagement with the tissue wall segment, said removing means including an elongate sheath having a lumen for containing the device and the fixation element, said lumen having a diameter larger than the delivery diameter and substantially less than the fixation diameter.

10. The apparatus of claim 9 wherein:

said fixation element comprises means for contacting the tissue wall segment over substantially its entire length upon expansion into said surface engagement.

11. The apparatus of claim 9 wherein:

said fixation element comprises means for at least slightly elastically deforming the tissue wall segment when in said surface engagement.

12. The apparatus of claim 9 wherein:

said fixation element, after said reversion to the fixation configuration, is elastic, and deforms elastically as it enters the lumen, by virtue of a distal advancement of the sheath relative to the device and the fixation element.

13. The apparatus of claim 9 wherein:

said fixation element, when in the radially expanded configuration, is a helix.

14. The apparatus of claim 13 wherein:

said helix has a substantially uniform pitch.

15. The apparatus of claim 13 wherein:

the helix is substantially elastic.

16. The apparatus of claim 9 wherein:

said device comprises a retrieval filament constructed of a recovery metal.

17. The apparatus of claim 9 wherein:

said device comprises a retrieval filament constructed of a biocompatible material other than the recovery metal.

18. The apparatus of claim 9 wherein:

said fixation element, when deformed into the delivery configuration, is substantially linear.