Flexible actuator mandrel for tissue apposition systems

Patent metadata

Field	Value
Publication number	US-10076327-B2
Application number	US-88207010-A
Country	US
Kind code	B2
Filing date	Sep 14, 2010
Priority date	Sep 14, 2010
Publication date	Sep 18, 2018
Grant date	Sep 18, 2018

Abstract

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

First claim

What is claimed is:

1. A system for approximating tissue, said system comprising:
a delivery catheter having a lumen extending therethrough;
an actuator rod disposed at least partially in the lumen, and having a proximal end and a distal end;
a flexible cable at least partially disposed in the lumen, the flexible cable comprises a plurality of layers of wires, the flexible cable having a proximal end and a distal end, wherein the proximal end of the flexible cable is coupled to the distal end of the actuator rod, and wherein the flexible cable is resiliently biased to return to a substantially linear configuration after being deflected 90° or more;
a coupler coupled to the distal end of the flexible cable; and
an implantable fixation device releasably attached to the coupler,
wherein the flexible cable is drawn such that an outer layer of the plurality of layers is formed of wires abutting along a substantially flat surface of the wires when viewed from a cross-section perpendicular to a length of the flexible cable and an inner layer of the plurality of wires maintain a substantially circular cross section, and the wires in the outer layer are not bonded to one another.

2. The system of claim 1 , wherein when rotated, the actuator rod transmits a torque ranging from at least 0.25 inch-ounces to 0.74 inch-ounces with a substantially 1 to 1 torque transmission ratio from the proximal end of the actuator rod to the distal end of the actuator rod.

3. The system of claim 1 , wherein the actuator rod transmits at least 1 pound of compressive force to the implantable fixation device without substantial buckling of the rod.

4. The system of claim 1 , wherein the actuator rod can withstand at least 5 pounds of tensile force without substantial elongation of the rod.

5. The system of claim 1 , wherein the flexible cable comprises a stranded cable.

6. The system of claim 1 , wherein the flexible cable comprises a plurality of wires wound in a helix.

7. The system of claim 1 , wherein the flexible cable comprises an inner core cable, the inner core cable comprising a plurality of wires.

8. The system of claim 1 , wherein at least half of a torque applied to the proximal end of the flexible cable is transmitted to the distal end thereof when the flexible cable is torqued in a first direction.

9. The system of claim 8 , wherein substantially all of the torque is transmitted from the proximal end to the distal end of the flexible cable.

10. The system of claim 8 , wherein the delivery catheter has a compression coil extending through the lumen from a proximal end to a distal end of the delivery catheter and wherein the actuator rod extends through the compression coil.

11. The system of claim 8 , wherein the lumen is comprised of stainless steel coil wire embedded in a polymer.

12. The system of claim 1 , wherein the flexible cable comprises a plurality of the wires are wound in a first direction, and wherein the flexible cable transmits torque in the first direction with a higher torque transmission ratio than in a second direction opposite the first direction.

13. The system of claim 1 , wherein the coupler comprises a proximal bore and a distal bore, and wherein the distal end of the cable is disposed in the proximal bore, and a portion of the fixation device is disposed in the distal bore.

14. The system of claim 1 , wherein the coupler comprises an enlarged proximal cylindrical portion and a smaller distal cylindrical portion.

15. The system of claim 14 , wherein the enlarged proximal portion is substantially the same diameter as the smaller distal cylindrical portion after the proximal portion has been swaged to the flexible cable.

16. The system of claim 1 , wherein the coupler has a first end and a second end opposite thereof, and wherein the first end of the coupler is swaged to the flexible cable, and the second end of the coupler is releasably attached to the fixation device.

17. The system of claim 1 , wherein the coupler has a first end and a second end opposite thereof, and wherein the first end is fixedly attached to the flexible cable, and the second end of the coupler is releasably attached to the fixation device.

18. The system of claim 17 , wherein the second end of the coupler is threadably coupled to the fixation device.

19. The system of claim 1 , wherein the implantable fixation device comprises: a pair of fixation elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to an inverted position wherein the engagement surfaces face away from each other; and an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position.

20. The system of claim 19 , wherein the implantable fixation device further comprises a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture tissue therebetween.

21. The system of claim 20 , wherein each fixation element is at least partially concave and each gripping element is at least partially recessed within the fixation element in a deployed configuration.

22. The system of claim 1 , further comprising a sleeve, the sleeve joining the proximal end of the flexible cable with the distal end of the actuator rod.

23. The system of claim 22 , wherein the sleeve is fixedly attached to the flexible cable and the actuator rod.

24. The system of claim 23 , wherein the sleeve comprises a central bore therethrough, and wherein the proximal end of the flexible cable and the distal end of the actuator rod are disposed in the central bore.

25. The system of claim 23 , wherein the sleeve is swaged to both the flexible cable and the actuator rod.

Assignees

• Ellis Kristin
• Dell Kent D
• Evalve Inc

Inventors

• Ellis Kristin
• Dell Kent D

Classifications

• A61F2/2463

  Implants forming part of the valve leaflets · CPC title

• A61B17/08 Primary

  Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound} · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61B2017/00407

  Ratchet means · CPC title

• A61B2017/00473

  Distal part, e.g. tip or head (A61B2017/00464 takes precedence) · CPC title