IMPLANTABLE DEVICES FOR CONTROLLING THE INTERNAL CIRCUMFERENCE OF AN ANATOMIC ORIFICE OR LUMEN

• US 20090125102A1
• Filed: 01/08/2009
• Published: 05/14/2009
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: Mitralsolutions, Inc.
• Inventors: CARTLEDGE, Richard G., Lee, Leonard Y.
• Granted Patent: US 8,945,210 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 5/0079 Pyloric or esophageal obstructions

Abstract

An implantable device for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implants are disclosed which employ various means 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 circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

Claims

1. A device for adjusting at least one of the shape and size of an anatomic orifice or lumen, comprising:

an implant body configured to be attached to tissue adjacent the anatomic orifice or lumen, wherein a surface of the implant body comes in contact with the anatomic orifice or lumen and said surface substantially defines a plane; and

an adjustment tool configured to be removably coupled to an interface location of the implant body such that the adjustment tool can be used to adjust at least one of the shape and size of the anatomic orifice or lumen, wherein when the adjustment tool is coupled to the interface location of the implant body the adjustment tool is not within the plane substantially defined by said surface of the implant body.

2. The device of claim 1, wherein the implant body comprises an annuloplasty ring.

3. The device of claim 2, wherein the annuloplasty ring comprises an outer layer through which sutures are placed to attach the annuloplasty ring to the tissue adjacent the anatomic orifice or lumen.

4. The device of claim 2, wherein the annuloplasty ring is rigid.

5. The device of claim 2, wherein the annuloplasty ring is flexible.

6. The device of claim 1, wherein the implant body includes barbs for attaching it to the tissue adjacent the anatomic orifice or lumen.

7. The device of claim 1, wherein the implant body comprises a tube formed into an annular shape and attached directly or indirectly to the tissue adjacent the anatomic orifice or lumen.

8. The device of claim 1, wherein the implant body can be introduced to a site adjacent the anatomic orifice or lumen using a minimally invasive procedure.

9. The device of claim 1, wherein the implant body can be introduced to a site adjacent the anatomic orifice or lumen using a catheter.

10. The device of claim 1, wherein the adjustment tool comprises a distal end and a proximal end, the distal end being removably coupled to the interface location of the implant body and the adjustment tool extending therefrom such that adjustments to the anatomic orifice or lumen can be made remotely using the proximal end.

11. The device of claim 1, wherein the adjustment tool can be introduced to the interface location of the implant body using a minimally invasive procedure.

12. The device of claim 1, wherein the adjustment tool can be used to adjust at least one of the shape and size of the anatomic orifice or lumen after resumption of physiologic flow in the anatomic orifice or lumen.

13. The device of claim 1, wherein the adjustment tool can be used to uniformly adjust at least one of the shape and size of the anatomic orifice or lumen.

14. The device of claim 1, wherein the adjustment tool can be used to non-uniformly adjust at least one of the shape and size of the anatomic orifice or lumen.

15. The device of claim 1, wherein the adjustment tool can be used to adjust at least one of the shape and size of the anatomic orifice or lumen on a beating heart.

16. A method for adjusting at least one of the shape and size of an anatomic orifice or lumen, comprising the steps of:

attaching an implant body to tissue adjacent the anatomic orifice or lumen, wherein a surface of the implant body comes in contact with the anatomic orifice or lumen and said surface substantially defines a plane;

coupling an adjustment tool to an interface location of the implant body, wherein when the adjustment tool is coupled to the interface location of the implant body the adjustment tool is not within the plane substantially defined by said surface of the implant body; and

using the adjustment tool to adjust at least one of the shape and size of the anatomic orifice or lumen.

17. The method of claim 16, wherein the implant body comprises an annuloplasty ring.

18. The method of claim 17, wherein the annuloplasty ring comprises an outer layer through which sutures are placed to attach the annuloplasty ring to the tissue adjacent the anatomic orifice or lumen.

19. The method of claim 17, wherein the annuloplasty ring is rigid.

20. The method of claim 17, wherein the annuloplasty ring is flexible.

21. The method of claim 16, wherein the implant body includes barbs for attaching it to the tissue adjacent the anatomic orifice or lumen.

22. The method of claim 16, wherein the implant body comprises a tube formed into an annular shape and attached directly or indirectly to the tissue adjacent the anatomic orifice or lumen.

23. The method of claim 16, wherein the step of attaching the implant body to tissue adjacent the anatomic orifice or lumen is performed using a minimally invasive procedure.

24. The method of claim 16, wherein the step of attaching the implant body to tissue adjacent the anatomic orifice or lumen is performed using a catheter.

25. The method of claim 16, wherein the adjustment tool comprises a distal end and a proximal end, the distal end being removably coupled to the interface location of the implant body and the adjustment tool extending therefrom such that the step of using the adjustment tool to adjust at least one of the shape and size of the anatomic orifice or lumen can be performed remotely using the proximal end.

26. The method of claim 16, wherein the step of coupling the adjustment tool to an interface location of the implant body is performed using a minimally invasive procedure.

27. The method of claim 16, wherein the step of using the adjustment tool to adjust at least one of the shape and size of the anatomic orifice or lumen is performed after resumption of physiologic flow in the anatomic orifice or lumen.

28. The method of claim 16, wherein the adjustment of at least one of the shape and size of the anatomic orifice or lumen is uniform.

29. The method of claim 16, wherein the adjustment of at least one of the shape and size of the anatomic orifice or lumen is non-uniform.

30. The method of claim 16, wherein the adjustment of at least one of the shape and size of the anatomic orifice or lumen is made on a beating heart.