Implantable devices for controlling the size and shape of an anatomical structure or lumen

• US 8,758,372 B2
• Filed: 05/21/2007
• Issued: 06/24/2014
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cartledge, Richard G., Lee, Leonard Y., Fann, James I., Friedmann, Josef L., Greene, James L.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US11/802,264
• Publication Number:
  US 20080027483A1
• Time in Patent Office: 2,591 Days
• Field of Search: 606/151, 606/153, 606/158, 606/218, 606/201, 606/203, 335/12, 623/2.36, 623/2.37, 600/37
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.

Claims

1. An implantable device system for controlling at least one of the shape and size of an anatomical structure or lumen, comprising:

an implantable device having dimensions and adapted for attachment to an anatomical structure or lumen, said implantable device comprising an adjustable member and a plurality of telescopically arranged hollow tubes, said adjustable member configured to receive an adjustment tool and configured to both increase and decrease the dimensions of the implantable device by expanding between a fully contracted configuration and a fully expanded configuration, wherein said implantable device comprises at least one of said hollow tubes having at least one protuberance and at least one threaded rod threadedly engaged with said at least one protuberance such that rotation of the threaded rod causes the threaded rod to move axially within the hollow tube; and

a torqueable adjustment tool configured to provide adjustment of the dimensions of the implantable device, wherein adjustment of said adjustable member adjusts the size of the implantable device generally in a preferred dimension by varying the extent of the telescopic arrangement of the tubes between the fully expanded configuration and the fully contracted configuration, wherein said hollow tubes remain nested when expanding between the fully contracted and fully expanded configurations.

2. The system of claim 1, wherein the at least one protuberance comprises at least one thread.

3. The system of claim 2, wherein said implantable device comprises an inner cable to translate rotational motion to said threaded rod.

4. The system of claim 1, wherein said implantable device comprises a flexible tube covering an outer layer of said implant device.

5. The system of claim 1, wherein adjustment of said adjustable member adjusts the size of the implant device generally in an anterior-posterior dimension.

6. The system of claim 1, further comprising a sensor coupled to the implantable device.

7. The system of claim 6, wherein the sensor measures at least one of pressure, temperature, and flow across the implantable device.

8. The system of claim 1, wherein said adjustment tool comprises a handle, said handle including a member to quantify a size change of the implantable device.

9. The system of claim 1, wherein said adjustment tool is configured to impart reciprocating action to the adjustable member.

10. The system of claim 9, wherein said adjustable member comprises a clover gear to transmit radial torque.

11. The system of claim 10, wherein said adjustable member coverts axial force applied from said adjustment tool to a rotation force applied to the implantable device.

12. The system of claim 1, wherein said adjustment tool is configured to provide both course adjustment and fine adjustment of said implantable device.

13. An implantable device system for controlling at least one of the shape and size of an anatomical structure or lumen, comprising:

an implantable device having dimensions and adapted for attachment to an anatomical structure or lumen, said implantable device comprising at least one adjustable member configured to receive an adjustment tool and configured to both increase and decrease the dimensions of the implantable device, wherein the implantable device includes dual threads formed by grooves that provide preferential adjustment of one side of the implantable device, wherein said implantable device comprises at least one hollow tube and at least one threaded rod having said grooves threadedly engaged with the hollow tube such that rotation of the threaded rod causes the threaded rod to move axially within the hollow tube; and

a torqueable adjustment tool configured to provide adjustment of the dimensions of the implantable device.

14. The system of claim 13, wherein said implantable device comprises at least one inner cable to translate rotational motion to said threaded rod.

15. The system of claim 13, wherein the implantable device includes a plurality of telescopically arranged hollow tubes, a dimension of the implantable device being altered by varying the extent of the telescopic arrangement of the tubes between expanded and contracted configurations.

16. The system of claim 13, wherein the implantable device includes a structure engaging the dual threads.

17. An implantable device adapted for attachment to an anatomical structure or lumen for controlling the size and/or shape of the anatomical structure or lumen, said device comprising:

an anterior region comprising one or more hollow rigid tubes having at least one protuberance threadedly engaged with one or more threaded rods having grooves forming threads;

a posterior region comprising one or more hollow rigid tubes and an adjustable member configured to translate rotational motion to at least one inner cable;

said inner cable operatively connected to said adjustable member and said threaded rod so as to translate rotational motion from said adjustable member to said threaded rod, wherein rotation of said threaded rod can both increase and decrease at least one dimensional relationship between the anterior region and the posterior region.

18. The implantable device of claim 17, further comprising at least one flexible tube that covers at least a portion of the anterior region and the posterior region.

19. The implantable device of claim 17, further comprising a micro-electromechanical motor system to commence rotational movement in said adjustable member.

20. The implantable device of claim 17, wherein one or more of the hollow rigid tubes of the anterior region or posterior region are telescopically arranged, a dimension of the implantable device being altered by varying the extent of the telescopic arrangement of the tubes between expanded and contracted configurations.

21. The implantable device of claim 17, wherein the at least one protuberance comprises a thread.

22. An implantable device system for controlling at least one of the shape and size of an anatomical structure or lumen, comprising:

an implantable device adapted for attachment to an anatomical structure or lumen, said implantable device comprising at least one hollow tube having at least one protuberance and at least one threaded rod having grooves forming threads threadedly engaged with the at least one protuberance such that rotation of the threaded rod causes the threaded rod to move axially within the hollow tube, said implantable device including an adjustable member configured to receive an adjustment tool; and

an adjustment tool configured to engage the adjustable member for adjusting at least one of the shape and size of the implantable device by varying the extent of the engagement of the at least one threaded rod and the at least one hollow tube.

23. The system of claim 22, wherein said implantable device includes an inner cable to translate rotational motion to said threaded rod.

24. The system of claim 22, wherein the implantable device includes a plurality of telescopically arranged hollow tubes, a dimension of the implantable device being altered by varying the extent of the telescopic arrangement of the tubes between expanded and contracted configurations.

25. An implantable device system for controlling at least one of the shape and size of an anatomical structure or lumen, comprising:

an implantable device adapted for attachment to an anatomical structure or lumen, said implantable device comprising a hollow tube having a flexible inner cable having a longitudinal axis and first and second ends, a rotatable adjustable member attached to said first end of said inner cable, and a rod rotatably received within said hollow tube and attached to said second end of said inner cable, said adjustable member configured to receive an adjustment tool; and

an adjustment tool configured to provide adjustment of at least one of the shape and size of the implantable device by rotation of the inner cable about its longitudinal axis by said adjustable member and rotation of said rod within said hollow tube.

26. The system of claim 25, wherein said adjustable member causes rotational motion of said inner cable in a clockwise and counter clockwise direction.

27. The system of claim 25, wherein the implantable device includes a plurality of telescopically arranged hollow tubes, a dimension of the implantable device being altered by varying the extent of the telescopic arrangement of the tubes between expanded and contracted configurations.

28. The system of claim 27, wherein said implantable device comprises at least one of said hollow tubes and at least one threaded rod having grooves forming threads threadedly engaged therewith such that rotation of the threaded rod causes the threaded rod to move axially within the hollow tube.

29. An implantable device system for controlling at least one of the shape and size of an anatomical structure or lumen, comprising:

an implantable device adapted for attachment to an anatomical structure or lumen, said implantable device comprising a hollow tube having a flexible inner cable having first and second ends and a longitudinal axis extending therethrough conforming to the shape of the implantable device, a rotatable adjustable member attached to said first end of said inner cable, and a rod rotatably received within said hollow tube and attached to said second end of said inner cable, said adjustable member configured to receive an adjustment tool; and

an adjustment tool configured to provide adjustment of at least one of the shape and size of the implantable device by rotation of the inner cable about its longitudinal axis by said adjustable member and rotation of said rod within said hollow tube.