FLEXIBLE ACTUATOR MANDREL FOR TISSUE APPOSITION SYSTEMS

• US 20120065464A1
• Filed: 09/14/2010
• Published: 03/15/2012
• Est. Priority Date: 09/14/2010
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Dell, Kent D., Ellis, Kristin
• Granted Patent: US 10,076,327 B2
• Time in Patent Office: Days
• US Class Current: 600/104
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 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 Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets

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.

Claims

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 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.

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 1, wherein the flexible cable comprises a plurality of wires 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.

11. 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.

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

13. The system of claim 12, 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.

14. 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.

15. 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.

16. The system of claim 15, wherein the second end of the coupler is threadably coupled to the fixation device.

17. 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.

18. The system of claim 17, 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.

19. The system of claim 18, 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.

20. 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.

21. The system of claim 20, wherein the sleeve is fixedly attached to the flexible cable and the actuator rod.

22. The system of claim 21, 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.

23. The system of claim 21, wherein the sleeve is swaged to both the flexible cable and the actuator rod.