Delivery device for stimulating the sympathetic nerve chain

• US 20060155344A1
• Filed: 02/03/2003
• Published: 07/13/2006
• Est. Priority Date: 02/01/2002
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Rezai, Ali, Sharan, Ashwini, Harman, Thomas MacMartin II
• Granted Patent: US 7,477,945 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

The present invention provides a device and assembly for electrically and/or chemically stimulating individual ganglion and a plurality of ganglia of the nervous system, and particularly to ganglia of the sympathetic nerve chain. A device is provided that generally wraps around an individual ganglion and conforms to the shape of the ganglion without exerting excessive pressure on the ganglion to damage the ganglion. An assembly is also provided that includes an axially elongated shaft that can be positioned adjacent to the sympathetic nerve chain and that can receive a plurality of ganglion stimulators that can slidably engage with the outer surface of the shaft. As additional ganglia are desired to be stimulated, each of the plurality of ganglion stimulators can be added to the shaft to engage the outer surface of the shaft and can be positioned adjacent to the ganglia desired to be stimulated.

Claims

1. A delivery device for stimulating a ganglion of the nervous system, the device comprising:

a first series of flexibly connected delivery contacts, wherein a leading delivery contact of the first series of flexibly connected delivery contacts is engagably associated with a trailing delivery contact of the first series of flexibly connected delivery contacts in an operative position of the delivery device; and

a second series of flexibly connected delivery contacts flexibly connected to the first series of flexibly connected delivery contacts, wherein a leading delivery contact of the second series of flexibly connected delivery contacts is engagably associated with a trailing delivery contact of the second series of flexibly connected delivery contacts in an operative position of the delivery device, wherein the delivery device maintains a substantially ovoid configuration when in an operative position.

2. The device of claim 1, wherein the first series of flexibly connected delivery contacts are arranged in a concave configuration.

3. The device of claim 1, wherein the second series of flexibly connected delivery contacts are arranged in a convex configuration.

4. The device of claim 1, further comprising a third series of flexibly connected delivery contacts located between and connected to both the first series of flexibly connected delivery contacts and the second series of flexibly connected delivery contacts, wherein a leading delivery contact of the third series of flexibly connected delivery contacts is engagably associated with a trailing delivery contact of the third series of flexibly connected delivery contacts in an operative position of the delivery device.

5. The device of claim 4, wherein the first series of flexibly connected delivery contacts comprises four delivery contacts, the second series of flexibly connected delivery contacts comprises four delivery contacts and the third series of flexibly connected delivery contacts comprises four delivery contacts.

6. The device of claim 4, wherein the first series of flexibly connected delivery contacts has a first diameter, the second series of flexibly connected delivery contacts has a second diameter, and the third series of flexibly connected delivery contacts has a third diameter, the third diameter being greater than the first diameter and the third diameter being greater than the second diameter in an operative position of the device.

7. The device of claim 1, wherein each of the first series of flexibly connected delivery contacts comprises an electrode and each of the second series of flexibly connected delivery contacts comprises an electrode.

8. The device of claim 1, wherein each of the first series of flexibly connected delivery contacts comprises a drug port and each of the second series of flexibly connected delivery contacts comprises a drug port.

9. The device of claim 1, wherein each of the first series of flexibly connected delivery contacts is insertable into a ganglion and each of the second series of flexibly connected delivery contacts is insertable in a ganglion.

10. The device of claim 1, wherein each of the first and second series of flexibly connected delivery contacts has a trapezoidal configuration.

11. The device of claim 1, wherein each of the first and second series of flexibly connected delivery contacts has an inner ganglion-facing surface and an outer surface, each of the inner ganglion-facing surfaces of each of the first and second series of flexible connected electrical delivery contacts having a concave configuration.

12. An assembly for stimulating ganglia comprising the device of claim 1 and further comprising an axially elongated shaft that is slidably engagable with the device of claim 1.

13. The device of claim 1, wherein the ganglion is a sympathetic ganglion of a sympathetic nerve chain.

14. An assembly for stimulating a ganglia comprising:

an axially elongated shaft having an inner surface and an outer surface;

a first probe including at least one delivery element disposed thereon, the first probe having a distal end and a proximal end, the distal end of the first probe slidably engagable with the outer surface of the shaft, the proximal end of the first probe insertable in a ganglion; and

a second probe including at least one delivery element disposed thereon, the second probe having a distal end and a proximal end, the distal end of the second probe slidably engagable with the outer surface of the shaft, the proximal end of the second probe insertable in a ganglion, wherein in an operative position the distal end of the first probe and the distal end of the second probe are securedly attached to the outer surface of the shaft.

15. The assembly of claim 14, further comprising a limit stop detachably engaged with the outer surface of the shaft.

16. The device of claim 14, wherein the first probe defines a first prong and a second prong and the second probe defines a first prong and a second prong.

17. A kit comprising the assembly of claim 14.

18. The assembly of claim 14, wherein the ganglia is sympathetic ganglia.

19. An assembly for stimulating ganglia comprising:

an axially elongated shaft having an inner surface and an outer surface;

a first terminal member including at least one delivery element disposed thereon, the first terminal member having a distal end and a proximal end, the distal end of the first terminal member slidably engagable with the outer surface of the shaft, the proximal end of the first terminal member having a generally concave configuration and adjacently positionable to a ganglion; and

a second terminal member including at least one delivery element disposed thereon, the terminal member having a distal end and a proximal end, the distal end of the second terminal member slidably engagable with the outer surface of the shaft, the proximal end of the second terminal member having a generally concave configuration and adjacently positionable to a ganglion, wherein in an operative position the distal end of the first terminal member and the distal end of the second terminal member are securedly attached to the outer surface of the shaft.

20. A kit comprising the assembly of claim 19.

21. The assembly of claim 19, further comprising a limit stop detachably engaged with the outer surface of the shaft.

22. The assembly of claim 19, wherein the ganglia are sympathetic ganglia.

23. An assembly for stimulating ganglia comprising:

an axially elongated shaft having an inner surface and an outer surface;

a first delivery structure slidably engagable with the outer surface of the shaft, the first delivery device comprising a first pair of connected clamping members, each of the first pair of connected clamping members having an outer wall and an inner concave wall, each of the inner concave walls of each of the first pair of connected clamping members having at least one delivery element disposed thereon; and

a second delivery structure slidably engagable with the outer surface of the shaft, the second delivery device comprising a second pair of connected clamping members, each of the second pair of connected clamping members having an outer wall and an inner concave wall, each of the inner concave walls of each of the second pair of connected clamping members having at least one delivery element disposed thereon, wherein in an operative position the first and second delivery structures are securedly attached to the outer surface of the shaft.

24. The assembly of claim 23, further comprising a limit stop detachably engaged with the outer surface of the shaft.

25. The assembly of claim 23, wherein the ganglia are sympathetic ganglia.

26. A kit comprising the assembly of claim 23.

27. The assembly of claim 23, wherein the first pair of connected clamping members are hingedly connected to each other and the second pair of connected clamping members are hingedly connected to each other.

28. A method of stimulating a ganglion comprising:

encasing a delivery device around at least a portion of a ganglion, wherein the delivery device comprises at least one delivery element; and

providing a stimulation signal to the at least one delivery element to stimulate the ganglion.

29. The method of claim 28, wherein the delivery device conforms to the shape of the ganglion and maintains an ovoid shape in an operative position of the device.

30. A method of stimulating sympathetic ganglia of the sympathetic nerve chain comprising:

positioning an axially elongated shaft adjacent to the sympathetic nerve chain, the shaft having an outer surface;

slidably engaging a first ganglion stimulator with the outer surface of the shaft, the first ganglion stimulator comprising at least one first delivery element;

placing the first ganglion stimulator adjacent to a first ganglion;

securing the first ganglion stimulator to the outer surface of the shaft; and

providing a stimulation signal to the at least one first delivery element to stimulate the first ganglion.

31. The method of claim 30, further comprising:

slidably engaging a second ganglion stimulator with the outer surface of the shaft, the second ganglion stimulator comprising at least one second delivery element;

placing the second ganglion stimulator adjacent to a second ganglion;

securing the second ganglion stimulator to the outer surface of the shaft; and

providing a stimulation signal to the at least one second delivery element to stimulate the second ganglion.