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

• US 9,107,750 B2
• Filed: 01/03/2008
• Issued: 08/18/2015
• 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:
  US12/522,089
• Publication Number:
  US 20110066231A1
• Time in Patent Office: 2,784 Days
• Field of Search: 623/213, 623/2.37, 623/1.36, 623/2.11, 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 device for positioning an adjustable implant device having an adjustable dimension adjacent to target tissue, comprising:

an implant holding element configured to releasably hold said adjustable implant device, said implant device having an adjustment member operative for adjusting the dimension of the implant device;

a rotatable adjustment tool having a distal end and a proximal end;

a tool holding element directly attached to the rotatable adjustment tool and configured to releasably hold the adjustment tool adjacent the implant holding element and to allow rotation of the adjustment tool while so held, said adjustment tool having the distal end releasably coupled to the adjustment member and configured to adjust the dimension of said adjustable implant device by rotation of the adjustment tool while held by the tool holding element, said tool holding element coupled longitudinally moveably to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom; and

an implant securing element having a configuration effective to secure said implant to said target tissue.

2. The device of claim 1, wherein said implant securing element has a first configuration adapted for penetrating tissue and a tip portion adapted for penetrating tissue and a second configuration adapted for engaging tissue.

3. The device of claim 1, wherein the implant holding element comprises a plurality of elongated structures having a proximal end and a distal end, the distal end adapted to be releasably coupled to the adjustable implant device, and the proximal end coupled to an implant holding element guide.

4. The device of claim 3, wherein the tool holding element is coupled to the implant holding element for releasably holding the adjustment tool.

5. The device of claim 3, wherein at least one of the elongated structures is hollow and adapted for dischargeably holding the implant securing element.

6. The device of claim 1, further including an implant positioning element surrounded by the implant holding element.

7. The device of claim 6, wherein the implant positioning element comprises a plurality of flexible elongated members, and wherein the implant holding element comprises a plurality of elongated structures.

8. The device of claim 7, further including an implant holding element guide for supporting and guiding the elongated structures.

9. A system for controlling the internal perimeter of an anatomic orifice or lumen disposed adjacent target tissue, comprising:

a rotatable adjustment tool having a distal end;

an adjustable implant device including an adjustable perimeter and a perimeter adjustment mechanism having a docking element configured to operably engage the adjustment tool, said perimeter adjustment mechanism being operably connected with said docking element, wherein the distal end of the adjustment tool is configured to releasably engage said docking element for rotation of the docking element;

an implant placement device comprising an implant holding element;

an implant securing element configured to secure said adjustable implant device to said target tissue, wherein the adjustment tool is removeably coupled to the implant holding element; and

a tool holding element attached to said adjustment tool and configured to hold said adjustment tool adjacent the implant holding element and to allow rotation thereof while so held and engaged with said docking element, said tool holding element coupled longitudinally moveably to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom.

10. The system of claim 9 wherein said implant securing element comprises a tip portion configured to penetrate tissue, said implant securing element being configured to assume at least a first configuration and a second configuration, said first configuration being adapted for penetrating tissue, and said second configuration adapted for engaging tissue.

11. The device of claim 9, wherein the implant holding element comprises a plurality of elongated structures adapted to be releasably attached to the adjustable implant device.

12. The device of claim 11, further including an implant device positioning element, and wherein the implant holding element forms an enclosure surrounding the implant device positioning element.

13. The device of claim 11, wherein the elongated structures are hollow for storing the implant securing element.

14. The device of claim 9, further including an implant device positioning element comprising a plurality of flexible elements.

15. The device of claim 14, wherein the tool holding element further including a guide for guiding the implant holding element.

16. The device of claim 15, wherein the tool holding element includes an opening for the passage of the implant device positioning element.

17. A device for adjusting an adjustable implant device having an adjustable dimension, comprising:

an implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant device, said implant device having an adjustment member operative for adjusting the dimension of the implant device;

a rotatable adjustment tool having a proximal end and a distal end, the distal end adapted to be operatively and releasably coupled to the adjustment member of the adjustable implant device for adjusting at least one of the size or shape of the adjustable implant device by rotation of the adjustment tool;

an implant positioning element surrounded by the implant holding element, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool; and

a tool guide releasably attached to the adjustment tool and coupling the adjustment tool to the implant holding element, wherein the adjustment tool is rotatable for adjusting the adjustable implant device while being coupled to the implant holding element by the tool guide and coupled to the adjustment member, said tool guide coupled longitudinally moveably to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom.

18. The device of claim 17, further including a plurality of securing elements for securing the adjustable implant device adjacent to an anatomical orifice or lumen.

19. A device for positioning and adjusting an adjustable implant, comprising:

an implant positioning element;

an implant holding element surrounding the implant positioning element, the implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant; and

an adjustment tool having a proximal end and a distal end, the distal end of the adjustment tool adapted to be operatively coupled to the adjustable implant for adjusting at least one of the size or shape of the adjustable implant;

wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool.

20. The device of claim 19 wherein the implant positioning element comprises a plurality of elongated flexible members.

21. The device of claim 20, further including a plurality of securing elements for securing the adjustable implant adjacent to an anatomical orifice or lumen.

22. A device for adjusting an adjustable implant having an adjustable dimension, comprising;

an elongated flexible implant positioning element comprising a plurality of elongated flexible members;

an elongated implant holding element surrounding the implant positioning element, the implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant, said implant having an adjustment member operative for adjusting the dimension of the implant;

a rotatable adjustment tool having a proximal end and a distal end, the distal end of the adjustment tool adapted to be operatively and rotatably coupled to the adjustment member of the adjustable implant for adjusting at least one of the size or shape of the adjustable implant by rotation of the adjustment tool; and

a tool guide releasably attached to the adjustment tool and coupling the adjustment tool to the implant holding element, wherein the adjustment tool is rotatable for adjusting at least one of the size or shape of the adjustable implant while being coupled to the implant holding element by the tool guide and coupled to the adjustment member, said tool guide coupled longitudinally moveably to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom.

23. The device of claim 22, wherein the implant holding element comprises a plurality of elongated hollow structures adapted to dischargeably receive at least one securing element for securing the adjustable implant adjacent to an anatomical orifice or lumen.

24. A system for controlling the internal perimeter of an anatomic orifice or lumen disposed adjacent target tissue, comprising:

an adjustment tool;

an adjustable implant device having an adjustable perimeter, a perimeter adjustment mechanism, and a docking element configured to operably engage the adjustment tool, said perimeter adjustment mechanism being operably connected with said docking element, wherein the adjustment tool is configured to operably engage said docking element;

an implant placement device comprising an implant engagement element, wherein the implant engagement element comprises a plurality of elongated structures adapted to be releasably attached to the adjustable implant device; and

an implant securing element configured to secure said adjustable implant device to said target tissue, wherein the adjustment tool is removeably coupled to the implant engagement element, wherein the elongated structures are hollow for storing the implant securing element.

25. A system for controlling the internal perimeter of an anatomic orifice or lumen disposed adjacent target tissue, comprising:

an adjustment tool;

an adjustable implant device having an adjustable perimeter, a perimeter adjustment mechanism, and a docking element configured to operably engage the adjustment tool, said perimeter adjustment mechanism being operably connected with said docking element, wherein the adjustment tool is configured to operably engage said docking element;

an implant placement device comprising an implant engagement element;

an implant securing element configured to secure said adjustable implant device to said target tissue, wherein the adjustment tool is removeably coupled to the implant engagement element;

an implant device positioning element comprising a plurality of flexible elements surrounding the implant engagement element, wherein said flexible elements expand and contract responsive to the adjustment of the adjustable implant device by the adjustment tool; and

a guide for supporting and guiding the implant engagement element, wherein the guide includes an opening for the passage of the implant device positioning element.

26. A device for adjusting an adjustable implant device, comprising:

an implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant device;

an adjustment tool having a proximal end and a distal end, the distal end adapted to be operatively coupled to the adjustable implant device for adjusting at least one of the size or shape of the adjustable implant;

a tool guide for releasably coupling the adjustment tool to the implant holding element, wherein the adjustment tool is operative for adjusting the adjustable implant while being coupled to the implant holding element by the tool guide; and

an implant positioning element surrounded by the implant holding element, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool.

27. A device for adjusting an adjustable implant, comprising;

an elongated flexible implant positioning element;

an elongated implant holding element surrounding the implant positioning element, the implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant, wherein the implant holding element comprises a plurality of elongated hollow structures adapted to dischargeably receive at least one securing element for securing the adjustable implant adjacent to an anatomical orifice or lumen;

an adjustment tool having a proximal end and a distal end, the distal end of the adjustment tool adapted to be operatively coupled to the adjustable implant for adjusting at least one of the size or shape of the adjustable implant; and

a tool guide for releasably coupling the adjustment tool to the implant holding element, wherein the adjustment tool is operative for adjusting at least one of the size or shape of the adjustable implant while being coupled to the implant holding element by the tool guide.

28. A device for positioning an adjustable implant device adjacent to target tissue, comprising:

an implant holding element configured to releasably hold said adjustable implant device;

a tool holding element configured to hold an adjustment tool adjacent the implant holding element and to allow operation thereof while so held, said adjustment tool being configured to adjust said adjustable implant device;

an implant securing element having a configuration effective to secure said implant to said target tissue; and

an implant positioning element surrounded by the implant holding element, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool.

29. A system for controlling the internal perimeter of an anatomic orifice or lumen disposed adjacent target tissue, comprising:

an adjustment tool;

an adjustable implant device having an adjustable perimeter, a perimeter adjustment mechanism, and a docking element configured to operably engage the adjustment tool, said perimeter adjustment mechanism being operably connected with said docking element, wherein the adjustment tool is configured to operably engage said docking element;

an implant placement device comprising an implant engagement element;

an implant securing element configured to secure said adjustable implant device to said target tissue, wherein the adjustment tool is removeably coupled to the implant engagement element; and

an implant device positioning element, wherein the implant engagement element forms an enclosure surrounding the implant device positioning element, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool.

30. A device for adjusting an adjustable implant, comprising;

an elongated flexible implant positioning element;

an elongated implant holding element surrounding the implant positioning element, the implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant;

an adjustment tool having a proximal end and a distal end, the distal end of the adjustment tool adapted to be operatively coupled to the adjustable implant for adjusting at least one of the size or shape of the adjustable implant; and

a tool guide for releasably coupling the adjustment tool to the implant holding element, wherein the adjustment tool is operative for adjusting at least one of the size or shape of the adjustable implant while being coupled to the implant holding element by the tool guide, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool.

31. A device for positioning an adjustable implant device adjacent to target tissue, comprising:

an implant holding element configured to releasably hold said adjustable implant device, wherein the implant holding element comprises a plurality of elongated structures;

an implant positioning element surrounded by the implant holding element, wherein the implant positioning element comprises a plurality of flexible elongated members;

an adjustment tool configured to adjust said adjustable implant device;

a tool holding element configured to hold the adjustment tool adjacent the implant holding element and to allow operation of the adjustment tool while so held, said tool holding element coupled longitudinally moveable to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom; and

an implant securing element having a configuration effective to secure said implant to said target tissue.

32. A device for adjusting an adjustable implant device, comprising:

an implant holding element having a proximal end and a distal end, the distal end adapted to be releasably coupled to an adjustable implant device;

an adjustment tool having a proximal end and a distal end, the distal end adapted to be operatively coupled to the adjustable implant device for adjusting at least one of the size or shape of the adjustable implant device;

an implant positioning element surrounded by the implant holding element, wherein the implant positioning element expands and contracts responsive to the adjustment of the adjustable implant by the adjustment tool; and

a tool guide for releasably coupling the adjustment tool to the implant holding element, wherein the adjustment tool is operative for adjusting the adjustable implant device while being coupled to the implant holding element by the tool guide, said tool guide coupled longitudinally moveable to said adjustment tool and said implant holding element between a first position arrangable adjacent said adjustable implant device and a second position arrangable spaced therefrom.