ENDOSCOPIC DEVICE DELIVERY SYSTEM

• US 20070299481A1
• Filed: 06/21/2007
• Published: 12/27/2007
• Est. Priority Date: 06/21/2006
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Syed, Baber, Sparks, Kurt, Wong, Ken, Wei, Michael, Imran, Mir
• Granted Patent: US 7,920,921 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A system and method are disclosed for an implantable gastric stimulation system within the stomach. The stimulation system includes an electronics anchor, electrode lead anchor, implantable pulse generator and external programmer. The electronics anchor is configured to attach to the stomach wall at a first location and the electrode lead anchor configured to attach to the stomach wall at a second location. The electrode lead anchor includes one or more electrodes configured to contact the stomach wall and a flexible lead portion coupled to the one or more electrodes at one end with an the electrical connector portion at the other end. The implantable pulse generator has electronic circuitry and is attached to the electronics anchor; the electronic circuitry is connected to the electrical connector of the electrode lead anchor and can communicate with the one or more electrodes. The external programmer is used to communicate with the electronic circuitry of the pulse generator via a telemetry device to provide stimulation instructions to the pulse generator.

Claims

1. A method for implanting an electrical stimulator comprising:

providing stimulator electronic circuitry and a first anchor configured to anchor stimulator electronic circuitry to a stomach wall wherein the first anchor comprises;

an anchor portion, a coupling portion and a guide coupling portion;

anchoring the first anchor to the stomach wall of a subject with the anchor portion;

coupling a guide to the guide coupling portion of the first anchor wherein the guide extends out of an esophagus of the subject;

guiding the stimulator electronic circuitry with the guide portion from out of the esophagus, into a coupled position with the coupling portion of the first anchor.

2. The method of claim 1 further comprising the steps of:

providing a second anchor configured to anchor an electrode to a stomach wall wherein the second anchor comprises;

an anchor portion;

a lead portion; and

an electrical connector portion, and wherein the stimulator further comprises a lead connector;

anchoring the second anchor to the stomach wall of the subject with the anchor portion wherein the electrical connector portion extends out of the esophagus of the patient; and

coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry.

3. The method of claim 2 further comprising the step of advancing the stimulator electronic circuitry through the esophagus into the stomach after coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry.

4. A method for implanting an electrical stimulator comprising:

providing stimulator electronic circuitry and an electrode anchor configured to anchor an electrode to a stomach wall, wherein the electrode anchor comprises;

an anchor portion;

a lead portion; and

an electrical connector portion, and wherein the stimulator further comprises a lead connector;

anchoring the electrode anchor to the stomach wall of the subject with the anchor portion wherein the electrical connector portion extends out of the esophagus of the patient; and

coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry.

5. A system for implanting an anchor on a stomach wall from within the stomach, the system comprising:

an anchor comprising an expandable portion and an elongate portion wherein when implanted in a stomach wall, the expandable portion is expanded to engage an outside of a stomach wall and the elongate portion extends through a stomach wall;

a dilator configured to dilate an opening through the stomach wall; and

a delivery cannula positionable through the opening in the stomach wall and configured to receive the anchor advanced through the cannula into an implanted position.

6. The system of claim 5 wherein the elongate portion of the anchor further comprises a guide coupling portion, and wherein the system further comprises a guide configured to couple to the guide coupling portion.

7. The system of claim 6 wherein the guide further comprises a tension mechanism configured to provide tension with respect to the elongate portion of the anchor when coupled thereto.

8. The system of claim 7 wherein the guide is configured to manipulate the anchor when coupled to the guide coupling portion and the tension mechanism.

9. A method of accessing space adjacent a serosa of a stomach through an esophagus of a patient, the method comprising:

piercing the stomach wall from within the stomach forming an opening in a stomach wall between the stomach and the space adjacent the serosa of the stomach;

positioning a first balloon on a first balloon catheter within the opening;

inflating the first balloon and dilating the opening to a first diameter;

advancing a sheath and the first balloon catheter in unison distally through the opening until the sheath extends through the stomach wall;

deflating the first balloon; and

withdrawing the first balloon catheter through the sheath.

10. The method of claim 9, wherein the first balloon is sized to span a thickness of the stomach wall and dilates the opening to a size in a range from about 2 mm to about 5 mm

11. The method of claim 9, wherein inflating the first balloon includes inflating the first balloon for a duration of more than about 45 seconds and to a pressure of greater than approximately 5 atmospheres.

12. The method of claim 9, further comprising decreasing the balloon pressure sufficiently to allow the first balloon to be translatable after dilation and prior to advancing the sheath and first balloon through the opening.

13. The method of claim 9, wherein the sheath has an outer surface adjacent an outer surface of the balloon when the sheath and the balloon are advanced in unison.

14. The method of claim 9, wherein the distal end of the sheath is advanced more than approximately 0.75 inches beyond the stomach wall.

15. The method of claim 9, wherein piercing the stomach wall comprises advancing a distal end of a hollow needle through the stomach wall while a proximal end of the needle extends out of the esophagus of the patient, advancing a first guidewire through the needle and the opening and into the space and withdrawing the needle over the first guidewire.

16. The method of claim 9, further comprising:

positioning a second balloon within the opening, the second balloon being sized to span the stomach wall;

inflating the second balloon and further dilating the opening to a second diameter;

advancing a crossing catheter and the second balloon catheter in unison through the opening until the crossing catheter extends through the stomach wall;

deflating the second balloon; and

withdrawing the second balloon catheter through the crossing catheter.

17. The method of claim 16, wherein positioning a second balloon within the opening comprises:

advancing a second guidewire through the sheath and into the space adjacent the serosa of the stomach;

withdrawing the sheath over the second guidewire, leaving the second guidewire in place through the opening; and

advancing the crossing catheter and the second balloon catheter with the second balloon over the second guidewire.

18. The method of claim 16, wherein inflating the second balloon includes inflating the second balloon for a duration of more than 45 seconds to a pressure of greater than approximately 5 atmospheres.

19. The method of claim 16, further comprising decreasing balloon pressure sufficiently to allow the second balloon to be translatable prior to advancing the crossing catheter and second balloon through the opening.

20. The method of claim 16, wherein the distal end of the crossing catheter is advanced more than about 0.75 inches through the stomach wall.

21. The method of claim 16, further comprising imaging one or more of the distal end of the first balloon catheter, the second balloon catheter, the sheath, and/or the crossing catheter.

22. The method of claim 16, wherein the second guidewire has a larger diameter than the first guidewire.

23. The method of claim 16, wherein the crossing catheter has an inner diameter of more than about 5 mm.

24. The method of claim 16, wherein the proximal end of the advanced crossing catheter extends out of the esophagus of the patient.

25. The method of claim 24, further comprising employing the crossing catheter as a delivery conduit through the esophagus of the patient to the space adjacent the serosa of the stomach or the peritoneal cavity.

26. A system for accessing space adjacent a serosa of a stomach through an esophagus, the system comprising:

a first balloon catheter having an expandable first balloon configured to slide over a guidewire extending out of the esophagus, the first balloon being sized to span the stomach wall thickness and to inflate to a first diameter and dilate an opening through the stomach wall; and

a sheath configured to slide over the first balloon catheter and contact the balloon inflated to the first diameter, the first diameter being sufficient to slide the sheath in unison with the first balloon catheter through the dilated opening until the sheath extends through the stomach wall into the space, the balloon being withdrawable proximally through the sheath when deflated.

27. The system of claim 26, wherein the first balloon has a length of greater than approximately 4 mm.

28. The system of claim 26, further comprising:

a hollow needle having a proximal end and a distal end, the proximal end configured to extend out of the esophagus of the patient and the distal end configured to pierce the stomach wall to create the opening into the space; and

a first guidewire configured to slide within the hollow needle.

29. The system of claim 26, further comprising:

a crossing catheter;

a second balloon catheter having a second balloon expandable from a deflated configuration to a second diameter;

the second balloon in the deflated configuration being smaller than the dilated opening to facilitate positioning the second balloon within the opening when the opening has been dilated by the first balloon, the second diameter being greater than an outer diameter of the crossing catheter, the second balloon of the second balloon catheter slidably advanceable through the crossing catheter when in the deflated configuration for bringing a distal end of the crossing catheter into contact with the inflated second balloon, the crossing catheter and second balloon catheter advanceable in unison from outside the esophagus through the opening until the crossing catheter extends through the stomach wall.

30. An anchor for implantation of a stimulation system within the stomach, the system comprising:

an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall;

an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall; and

a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall.

31. The anchor of claim 30, wherein the anchor is an electronics anchor, further comprising:

a tapered end on the proximal end of the elongate portion; and

a loop on the tapered end, wherein the tapered end and loop are configured to engage the distal end of a guide element for attachment of the retaining element to the elongate portion.

32. The anchor of claim 30, wherein the anchor is an electrode lead anchor, further comprising:

one or more electrodes with exposed surfaces on the elongate portion and/or the expandable portion; and

a flexible lead portion with electrical connectors therethrough having a distal end coupled to the one or more electrodes and a proximal end coupled to a lead connector, wherein the lead connector is configured to couple with electronic circuitry of a stimulator.

33. A method for implanting a stimulation system within the stomach comprising:

attaching an electrode lead anchor to the stomach wall at a first location, the electrode lead anchor having one or more electrodes in contact with the stomach wall and an electrical connector coupled to the electrode(s);

temporarily capping the electrical connector;

allowing a healing period for the first location in the stomach wall;

after the healing period, coupling the connector to a pulse generator having electronic circuitry;

implanting the electronic circuitry and transmitting stomach stimulation signals from the electronic circuitry to the stomach via the electrode(s).

34. The method of claim 33, wherein the healing period is longer than two weeks.

35. The method of claim 33, the electrode lead anchor further comprising a flexible lead portion with electrical connectors therethrough coupled to the electrodes at a distal end and the electrical connector portion at a proximal end, and a retaining element having one or more arms;

the method further comprising;

attaching an electronics anchor to the stomach wall at a first location;

attaching a temporary cap to the electrical connector portion;

attaching the temporary cap with the one or more arms of the retaining element;

after the healing period, separating the temporary cap from the one or more arms and removing the temporary cap;

coupling the electrical connector portion of the electrode lead anchor to the electronic circuitry in the electrical pulse generator; and

attaching the pulse generator with the electronics anchor.

36. A stimulation system for implantation within the stomach comprising:

an electronics anchor configured to attach to the stomach wall at a first location;

an electrode lead anchor configured to attach to the stomach wall at a second location, the electrode lead anchor having one or more electrodes configured to contact the stomach wall and a flexible lead portion with electrical connectors therethrough coupled to the one or more electrodes at a distal end and an the electrical connector portion at a proximal end;

a pulse generator coupled to the electronics anchor, the pulse generator having electronic circuitry coupled to the electrical connector portion of the electrode lead anchor, wherein the electronic circuitry is configured to communicate with the one or more electrodes;

an external programmer configured to communicate with the electronic circuitry of the pulse generator via a telemetry device to provide stimulation instructions.

37. The system of claim 36, wherein the electronics anchor comprises:

an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall

an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall;

a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall;

a tapered end on the proximal end of the elongate portion; and

a loop on the tapered end, wherein the tapered end and loop are configured to engage the distal end of a guide element for attachment of the retaining element to the elongate portion.

38. The system of claim 36, wherein the electrode lead anchor further comprises:

an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall

an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall

wherein the one or more electrodes have exposed surfaces on the elongate portion and/or the expandable portion; and

a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall.