Implantation of a medical device within a lumen

• US 8,216,158 B2
• Filed: 07/20/2005
• Issued: 07/10/2012
• Est. Priority Date: 07/20/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Johnson, Blake D.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Smith, Fangemonique
• Application Number:
  US11/186,414
• Publication Number:
  US 20070021736A1
• Time in Patent Office: 2,547 Days
• Field of Search: 600/593, 600/112, 600/377, 604/117, 604/164.01, 607/133, 606/119
• US Class Current: 600/593
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2217/005 with suction drainage system
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

A medical device implanted within a lumen of a patient, such as the esophagus, stomach, or another portion of the gastrointestinal tract, includes a device housing and a lead that extends from the device housing. An anchor member is located at a distal portion of the lead, and the lead includes one or more electrodes located between the device housing and the anchor member. A delivery system for implanting the medical device within the lumen includes an elongated delivery device and a needle. The needle includes a bore to receive the anchor member of the medical device. The delivery system inserts the anchor member through a passageway from the lumen, through the tissue, and back into the lumen.

Claims

1. A system for implantation of a medical device within a lumen of a patient, the system comprising:

the medical device, wherein the medical device comprises;

a device housing sized for introduction into the lumen,

electrical circuitry mounted within the device housing,

a tether member that includes a proximal end that is coupled to the device housing, and

an anchor member located at a distal portion of the tether member;

an elongated delivery device with a distal portion that defines a cavity;

a vacuum port to draw tissue of a wall of the lumen into the cavity;

a needle that defines a bore, wherein the bore receives the anchor member of the medical device, and wherein the needle is advanceable into the cavity and through the tissue disposed in the cavity while the anchor member is received by the bore to form a passageway from the lumen, through the tissue, and back into the lumen and to place the tether member within the passageway; and

an ejection tool that is advanceable through the bore of the needle to eject the anchor member from the bore when the needle has been advanced though the tissue such that the anchor member is in the lumen on a first side of the passageway through the tissue and the device housing is in the lumen on a second side of the passageway through the tissue.

2. The system of claim 1, wherein the tether member comprises a lead that includes at least one electrode located between the proximal end and the anchor member and coupled to the electrical circuitry within the device housing.

3. The system of claim 1, wherein the anchor member is elongate.

4. The system of claim 1, wherein the anchor member is substantially cylindrical.

5. The system of claim 1, wherein the anchor member has a width that substantially corresponds to the bore of the needle.

6. The system of claim 1, wherein the width of the anchor member is less than approximately 0.1 inches.

7. The system of claim 1, wherein the width of the anchor member is within a range from approximately 0.04 inches to approximately 0.06 inches.

8. The system of claim 1, wherein the width of anchor member is approximately 0.05 inches.

9. The system of claim 1, wherein the anchor member is sized to frictionally engage the needle when received by the bore of the needle.

10. The system of claim 1, wherein a longitudinal axis of the anchor member is substantially perpendicular to a longitudinal axis of the tether member.

11. The system of claim 1, wherein the needle further defines a slot that extends from a distal end of the needle.

12. The system of claim 11, wherein the slot extends axially from the distal end of the needle.

13. The system of claim 11, wherein a width of the slot is less than a width of the bore.

14. The system of claim 11, wherein the medical device further comprises a connecting member that connects the anchor member to the tether member, has a width that is less than a width of the anchor member and the tether member, and passes through the slot when the anchor member is received by the bore.

15. The system of claim 14, wherein the width of the connecting member substantially corresponds to a width of the slot.

16. The system of claim 14, wherein the connecting member is sized to frictionally engage the needle when passed through the slot.

17. The system of claim 11, wherein a width of the distal portion of the tether member is less than a width of the anchor member, and the distal portion of the tether member passes through the slot when the anchor member is received by the bore.

18. The system of claim 17, wherein the width of the distal portion of the tether member substantially corresponds to a width of the slot.

19. The system of claim 17, wherein the distal portion of the tether member is sized to frictionally engage the needle when passed through the slot.

20. The system of claim 1, wherein the distal portion of the elongated delivery device further comprises a receiving chamber in fluid communication with the cavity, the needle is advanceable through the tissue and into the receiving chamber, and the ejection tool ejects the anchor member into the receiving chamber.

21. The system of claim 1, wherein the elongated delivery device comprises an endoscopic delivery device.

22. A method for implanting a medical device within a lumen of a patient, the method comprising:

inserting an anchor member of the medical device into a bore of a needle;

advancing the needle through tissue of the lumen with the anchor member inserted in the bore to create a passageway from the lumen, through the tissue, and back into the lumen, and to place a tether member of the medical device coupled to the anchor member within the passageway; and

ejecting the anchor member from the bore to place the anchor member in the lumen on a first side of the passageway while a device housing of the medical device coupled to the tether member is located in the lumen on a second side of the passageway, wherein the anchor member and the device housing keep the tether member within the passageway.

23. The method of claim 22, further comprising drawing tissue of the lumen into a chamber of an elongated delivery device, wherein advancing the needle into tissue comprises advancing the needle though the tissue drawn into the chamber.

24. The method of claim 22, wherein the tether member comprises a lead that includes at least one electrode located between the proximal end and the anchor member and coupled to the electrical circuitry within the device housing, and the method comprises placing the electrode within the passageway through the tissue.

25. A system for implantation of a medical device within a lumen of a patient, the system comprising:

the medical device, wherein the medical device comprises;

a device housing sized for introduction into the lumen,

electrical circuitry mounted within the device housing,

a tether member that includes a proximal end that is coupled to the device housing, and

an anchor member located at a distal portion of the tether member;

an elongated delivery device with a distal portion that defines a cavity;

a vacuum port to draw tissue of a wall of the lumen into the cavity;

a needle that defines a bore, wherein the bore receives the anchor member of the medical device, and the needle is advanceable into the cavity and through the tissue disposed in the cavity while the anchor member is received by the bore to form a passageway from the lumen, through the tissue, and back into the lumen and to place the tether member within the passageway; and

an ejection tool that is advanceable through the bore of the needle to eject the anchor member from the bore when the needle has been advanced though the tissue such that the anchor member is in the lumen on a first side of the passageway through the tissue and the device housing is in the lumen on a second side of the passageway through tissue,

wherein the tether member comprises a lead that includes at least one electrode located between the proximal end and the anchor member and coupled to the electrical circuitry within the device housing.