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

• US 9,326,857 B2
• Filed: 04/09/2010
• Issued: 05/03/2016
• Est. Priority Date: 01/03/2007
• 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.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/757,687
• Publication Number:
  US 20110208295A1
• Time in Patent Office: 2,216 Days
• Field of Search: 623/213, 623/2.37, 227/175.1, 600/37
• US Class Current: 1/1
• 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/06071 with an abrupt angle formed between two adjacent sections
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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

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. A delivery system for positioning an adjustable implant, comprising:

a flexible implant positioning element comprising a plurality of flexible elongated members having a distal end and a proximal end, the implant positioning element constructed to have a radial expanded configuration and a radial contracted configuration;

an adjustable implant having an opening receiving therethrough the plurality of flexible elongated members between the distal end and the proximal end, the adjustable implant constructed to have at least one of an adjustable perimeter or shape;

a holding element releasably attached to the adjustable implant, the adjustable implant adapted to be moveable longitudinally over the plurality of flexible elongated members between the distal end and the proximal end by the holding element at least when the implant positioning element is arranged in the contracted configuration; and

an adjustment tool adapted to be operatively coupled to the implant for adjusting at least one of the perimeter or shape of the implant;

wherein adjusting the perimeter or shape of the implant by the adjustment tool is operative to radially expand and radially contract the implant positioning element between the expanded and contracted configurations.

2. The system of claim 1, wherein the implant includes an adjustment tool coupler configured to releasably engage the adjustment tool.

3. The system of claim 1, further including a plurality of securing elements for securing the implant adjacent to an anatomical orifice or lumen.

4. The system of claim 3, further including a trocar wherein the securing elements are received therein.

5. The system of claim 1, further including a plurality of elongated hollow structures each including at least one securing element for securing the implant adjacent to an anatomical orifice or lumen upon discharge therefrom.

6. The system of claim 1, wherein the implant comprises an annuloplasty ring.

7. A delivery system for positioning an adjustable implant comprising:

a flexible implant positioning element having a longitudinal axis comprising a plurality of flexible elongated members having a distal end and a proximal end, the implant positioning element being configured to be self-expanding from a contracted configuration to an expanded configuration;

an adjustable annuloplasty ring constructed to have an opening and at least one of an adjustable perimeter or shape, the annuloplasty ring configured for surrounding the implant positioning element between the distal end and proximal end when in both the contracted and expanded configurations, the annuloplasty ring including an adjustment tool coupler, the annuloplasty ring moveable along the longitudinal axis of the implant positioning element over the plurality of flexible elongated members when at least in the contracted configuration between the distal end and the proximal end;

a holding element for releasable attachment to the adjustable implant, wherein the holding element is adapted to move the adjustable implant longitudinally over the plurality of flexible elongated members when received within the opening of the annuloplasty ring between the distal end and proximal end;

an adjustment tool adapted to be operatively and releasably attached to the adjustment tool coupler for adjusting at least one of the perimeter or shape of the annuloplasty ring; and

a plurality of securing elements for securing the annuloplasty ring adjacent to an anatomical orifice or lumen.

8. The system of claim 7, further including a trocar wherein the securing elements are received therein.

9. The system of claim 8, wherein the securing elements have a first configuration when received within the trocar, and a second configuration different from the first configuration when discharged from the trocar.

10. The system of claim 9, wherein the securing elements when discharged from the trocar have a curved shape.

11. A delivery system for positioning an adjustable implant, comprising:

a flexible implant positioning element comprising a plurality of flexible elongated members having a longitudinal axis and a distal end and a proximal end, the plurality of flexible elongated members configured to be self-expanding from a contracted configuration to a radial expanded configuration;

an adjustable implant having an adjustment member configured for adjusting a perimeter or shape of the adjustable implant, the adjustable implant arranged surrounding the plurality of flexible elongated members and adapted to be moved along the longitudinal axis of the plurality of flexible elongated members between the distal end and the proximal end when the plurality of flexible elongated members are at least in the contracted configuration, wherein the adjustable implant includes an opening, and wherein the plurality of elongated flexible members of the implant positioning element is arranged extending therethrough; and

an adjustment tool having an end configured to be releasably attached to the adjustment member of the adjustable implant for adjusting at least one of the perimeter or shape of the adjustable implant, wherein the plurality of flexible elongated members radial self-expand to the expanded configuration upon expansion of the adjustable implant by operation of the adjustment member by the adjustment tool.

12. The system of claim 11, wherein the adjustable implant comprises an annuloplasty ring.

13. The system of claim 12, further including a holding element for releasable attachment to the adjustable implant, wherein the holding element is adapted to move the adjustable implant over the plurality of flexible elongated members.