Radially expandable fixation member

• US 5,221,261 A
• Filed: 08/10/1992
• Issued: 06/22/1993
• Est. Priority Date: 04/12/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Termin, Paul L., Porter, Christopher H.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/927,771
• Time in Patent Office: 316 Days
• Field of Search: 623/1, 623/11, 623/12, 606/159, 606/180, 606/191, 606/194, 604/96, 604/104-109, 604/174, 604/175, 128/642, 128/784, 128/785
• 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 natural lumen, e.g. vessels A61M25/04
• 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 With the fixation element positioned as desired, the sheath is withdrawn to permit the fixation element to self-expand against body tissue, thus to secure the fixation element and catheter.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 dilation 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, dependeing 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 plastically deformable tubular open weave fixation element constructed of a biocompatible material and a fastening means for permanently securing the fixation element to a selected region of said device, said fixation element being formable into a delivery configuration in which the fixation element has a delivery diameter and radially expandable to a fixation configuration in which the fixation element diameter is substantially greater than the delivery diameter; and

a deployment means operatively associated with said device for delivering said fixation element in said delivery configuration as said device is bodily inserted to selectively position said fixation element at a predetermined location within a body cavity, and for causing radial expansion of said fixation element into a surface engagement of the fixation element over substantially its entire length with a tissue wall segment defining said cavity at said predetermined location, to secure the fixation element to said wall segment and thus substantially fix said selected region within said body cavity and thereby secure the device with respect to the body cavity, said deployment means including an expansion means secured to said device, surrounded by said fixation element, and expandable to plastically deform said fixation element.

2. The apparatus of claim 1 wherein:

said selected region of said device is said distal end region.

3. The apparatus of claim 2 wherein:

said tubular fixation element is fastened concentrically on the distal end region of the device.

4. The apparatus of claim 3 wherein:

said fixation element is constructed of helical, braided strands of a biocompatible material.

5. The apparatus of claim 4 wherein:

said biocompatible material is stainless steel.

6. The apparatus of claim 4 wherein

said biocompatible material is a plastic.

7. The apparatus of claim 2 wherein:

said expansion means surrounds said device.

8. The apparatus of claim 7 wherein:

said device is a pliable catheter, and said expansion means comprises a pliable balloon surrounding said catheter, and a balloon inflation lumen formed along said catheter and open to the interior of said balloon, for dilatation of said balloon responsive to supplying a fluid under pressure to the balloon.

9. The apparatus of claim 8 wherein:

said fastening means integrally secures a distal end of said fixation element to the distal end region of the catheter.

10. The apparatus of claim 1 wherein:

said fixation element includes a plurality of helically wound strands forming an open weave cylinder.

11. The apparatus of claim 10 wherein:

said fastening means comprises a ring integrally securing said fixation element to said distal end region of the device.

12. The apparatus of claim 11 wherein:

said ring secures the distal end of said fixation element to said device.

13. 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 plastically deformable tubular fixation element and a fastening means for permanently securing the fixation element to a selected region of said device, said fixation element being formable into a delivery configuration in which the fixation element has a delivery diameter and further being radially expandable to a fixation configuration in which the fixation element diameter is substantially greater than the delivery diameter; and

a deployment means operatively associated with said device for delivering said fixation element in said delivery configuration as said device is bodily inserted to selectively position said fixation element at a predetermined location within a body cavity, and for causing radial expansion of said fixation element into a surface engagement of the fixation element over substantially its entire length with a tissue wall segment defining said cavity at said predetermined location, to at least slightly elastically deform the tissue wall segment to secure the fixation element to said wall segment and thus substantially fix said selected region within said body cavity and thereby secure the device with respect to the body cavity, said deployment means including an expansion means secured to said device, surrounded by said fixation element, and expandable to plastically deform said fixation element.

14. The apparatus of claim 13 wherein:

said fixation element is an open weave tubular member constructed of helical braided strands of a biocompatible material.

15. The apparatus of claim 13 wherein:

said tubular fixation element is fastened concentrically on the distal end region of the device.

16. The apparatus of claim 15 wherein:

said fastening means comprises a ring.

17. The apparatus of claim 16 wherein:

said ring secures the distal end of the fixation element to said device.

18. The apparatus of claim 13 wherein:

said expansion means surrounds the device.

19. The apparatus of claim 18 wherein:

said device is a pliable catheter, and said expansion means comprises a pliable balloon surrounding the catheter, and a balloon inflation lumen formed along the catheter and open to the interior of the balloon, for dilatation of the balloon responsive to supplying a fluid under pressure to the balloon.

20. A process for deploying and fixing a body implantable device, including the steps of:

permanently securing a plastically deformable tubular fixation element to a distal end region of an elongate body insertable device;

bodily inserting the device and the fixation element and delivering the device and fixation element to a predetermined location within a selected body cavity, with the tubular fixation element in a delivery configuration in which the fixation element has a delivery diameter;

with said fixation element at the predetermined location, enlarging an expansion means surrounded by the fixation element to radially expand the fixation element into a surface engagement with a tissue wall segment defining the cavity at the predetermined location, to secure the fixation element to the wall segment and substantially fix the distal end region within the body cavity, thereby to secure the device with respect to the body cavity.

21. The process of claim 20 wherein:

said step of enlarging an expansion means surrounded by the fixation element includes expanding the fixation element sufficiently to cause at least slight elastic deformation of the tissue wall segment.