Resorbable anchor arrangements for implantable devices and methods of making and using

• US 8,494,657 B2
• Filed: 04/29/2011
• Issued: 07/23/2013
• Est. Priority Date: 03/15/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carbunaru, Rafael, Whitehurst, Todd K., Jaax, Kristen N.
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/098,019
• Publication Number:
  US 20110208281A1
• Time in Patent Office: 816 Days
• Field of Search: 607/129
• US Class Current: 607/129
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

An implantable device includes a device body and at least one anchoring unit configured and arranged for anchoring the device body in a patient upon implantation. The anchoring unit includes a resorbable material that resorbs into the patient over a period of time after implantation.

Claims

1. An implantable device, comprising:

a device body configured and arranged to be implanted proximate to selected tissue in a patient, the device body comprising a distal portion, a proximal portion, at least one electrode disposed on the distal portion of the device body, at least one terminal disposed on the proximal portion of the device body, and at least one conductor extending along the device body from the at least one electrode to the at least one terminal; and

an anchoring unit disposed around a portion of the device body between the at least one electrode and the at least one terminal, the anchoring unit configured and arranged for anchoring the device body in the patient upon implantation, the anchoring unit comprising a ring-shaped unit forming, by itself, a closed loop defining a device opening configured and arranged for receiving a portion of the device body, the ring-shaped unit formed from a resorbable material that resorbs into the patient over a period of time after implantation, the resorption at least partially releasing the at least one electrode from the anchoring unit while the device body is implanted in the patient, the anchoring unit configured and arranged such that the period of time of resorption is sufficient to allow tissue ingrowth around the at least one electrode to anchor the at least one electrode prior to release of the at least one electrode due to at least a partial resorption of the anchoring unit, wherein the anchoring unit additionally defines at least one closed-loop anchoring opening extending therethrough, the anchoring opening configured and arranged for passage of at least one of at least one suture or at least one staple, the at least one anchoring opening being separate and distinct from the device opening.

2. The implantable device of claim 1, wherein the implantable device is one of a percutaneous lead or a paddle lead, and wherein the implantable lead is an electrode lead.

3. The implantable device of claim 2, wherein the anchoring unit is configured and arranged for coupling the device body to tissue using at least one suture, wherein resorption of the anchoring unit into the patient releases the device body from the at least one suture.

4. The implantable device of claim 2, wherein the anchoring unit and the device body are configured and arranged for passage of a suture between the anchoring unit and the device body.

5. The implantable device of claim 2, wherein the anchoring unit is configured and arranged for coupling the device body to tissue using at least one staple, wherein resorption of the anchoring unit into the patient releases the device body from the at least one staple.

6. The implantable device of claim 2, wherein the anchoring unit is configured and arranged for gluing the device body to tissue using the anchoring unit, wherein resorption of the anchoring unit into the patient releases the device body from the glue.

7. The implantable device of claim 2, wherein the anchoring unit is formed integrally with the device body.

8. The implantable device of claim 2, wherein the anchoring unit is removable from the device body.

9. The implantable device of claim 2, wherein the anchoring unit couples to the implantable device body by sliding the anchoring unit over at least a portion of the implantable device body.

10. The implantable device of claim 2, wherein the device body is configured and arranged for explanation from the patient after the resorbable material is resorbed by the patient.

11. The implantable device of claim 2, wherein the anchoring unit is disposed completely around the device body with the entire anchoring unit positioned between the at least one electrode and the at least one terminal.

12. A method of implanting the stimulation system of claim 2, the method comprising:

implanting the device body of the stimulation system into a patient;

disposing the anchoring unit of the stimulation system around a portion of the device body between the at least one electrode and the at least one terminal of the device body; and

anchoring the anchoring unit to the patient upon implantation with the device body disposed proximate to selected patient tissue.

13. The method of claim 12, further comprising removing the device body after enough of the resorbable material is resorbed by the patient to at least partially release the at least one electrode from the anchoring unit.

14. The method of claim 13, wherein resorption of the at least one anchoring unit fully releases the at least one of the electrodes from the at least one anchoring unit.

15. The method of claim 12, wherein anchoring the anchoring unit to the patient comprises suturing the device body to patient tissue using the anchoring unit.

16. The implantable device of claim 2, wherein the anchoring unit has a width along a dimension of the anchoring unit that is parallel with the closed loop defining the device opening, wherein the anchoring unit has a thickness along a dimension of the anchoring unit that is normal to the closed loop defining the device opening, and wherein the width is larger than the thickness.

17. A stimulation system comprising:

the implantable device of claim 2;

a control unit configured and arranged for receiving the electrode lead of the implantable device; and

a connector disposed on the control unit, the connector configured and arranged to removably receive the proximal portion of the device body of the electrode lead.

18. The stimulation system of claim 17, wherein the control unit is also implantable.

19. The stimulation system of claim 17, wherein the control unit comprises an implantable pulse generator, wherein, the implantable pulse generator provides electrical pulses along the at least one conductor of the implantable device to the at least one electrode of the implantable device.

20. The stimulation system of claim 19, wherein the implantable pulse generator is configured and arranged for implantation at a location that is remote from the anchoring unit.