Apparatus and methods for altering temperature in a region within the body

Abstract

Apparatus and methods for cooling and/or heating selected regions within a body are described herein. An implantable system is used to cool or heat nerve bodies down to about 15° C. to diminish nerve impulses. In one embodiment, the system can include an implantable unit containing a pumping mechanism and/or various control electronics. The system has a cooling element. The cooling element can be a Peltier junction or a catheter through which hot or cold fluid flows. The heated portion of the Peltier junction can be cooled by a liquid heat transfer medium which absorbs the heat from the junction and dissipates the heat elsewhere.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic of an embodiment of the cooling device with a pump.

FIG. 2 shows a schematic of an embodiment of the cooling device with a pump having electronics.

FIG. 3A shows a top view of an embodiment of the cooling element having a Peltier junction.

FIG. 3B shows an isometric view of an embodiment of the cooling element from FIG. 3A.

FIG. 4 shows a clamp variation of the cooling element.

FIG. 5 shows a helical variation of the cooling element.

FIG. 6 shows a segmented variation of the cooling element.

FIG. 7 shows a flexible sheet variation of the cooling element in a straight configuration.

FIG. 8 shows the variation of the cooling element of FIG. 7 in a partially curled, curved, or wrapped configuration.

FIG. 9 shows an externally controllable variation on the pump.

FIG. 10 shows an internally rotating variation on the pump.

FIG. 11 shows a transparent isometric view of one variation on the heat exchanger cuff.

FIG. 12 shows a transparent isometric view of another variation on the heat exchanger cuff.

FIG. 13 shows an isometric view of a device for injecting and aspirating coolant through the skin.

FIG. 14A shows a representative schematic of a variation on the cooling device having a single multi-lumened coolant tube.

FIG. 14B shows cross-section A-A from FIG. 14A of the variation on the multi-lumened coolant tube.

FIG. 15 shows an embodiment of the coolant tube wrapped with a metallic ribbon.

FIG. 16 shows an embodiment of the coolant tube braided with a metallic ribbon.

FIG. 17 shows an embodiment of the coolant tube covered with an insulative material.

FIG. 18 shows an embodiment of the cooling element.

FIG. 19 shows cross-section B-B of FIG. 18.

FIG. 20 shows a perspective view of cross-section C-C of FIG. 19.

FIG. 21 shows an embodiment of the cooling element.

FIG. 22 shows cross-section D-D of FIG. 21.

FIG. 23 shows a perspective view of cross-section E-E of FIG. 22.

FIG. 24 shows an embodiment of the cooling element.

FIG. 25 shows a perspective view of cross-section F-F of FIG. 24.

FIGS. 26 through 28 show an embodiment of a method of deploying the cooling element around a nerve.

FIG. 29 shows a variation of the cooling device implanted within a body and attached to the superior vena cava and a vagal nerve.

FIG. 30 shows a variation of the cooling device implanted within a body and attached to the superior vena cava and a region within the brain.

FIG. 31 shows an embodiment of using the cooling device attached to the posterior and anterior trunks of the vagus nerve.

FIG. 32 shows a partial see-through view of the leg illustrating an embodiment of using the cooling device attached to the femoral and sciatic nerves.

FIG. 33 illustrates a perspective view of a sagittal sectioning of a length of the spinal column.

FIG. 34 illustrates cross-section G-G of the spinal column.

FIG. 35 illustrates cross-section H-H of the spinal column.

FIG. 36 shows a sagittal section of vertebrae with a catheter inserted within the vertebral canal to cool a portion of the spinal column.

FIG. 37 illustrates an embodiment of a method of deploying an embodiment of the cooling element into the epidural space.

FIGS. 38, 40, 42, and 43 illustrate an embodiment of a method of deploying an embodiment of the cooling element into the epidural space.

FIG. 39 illustrates cross-section J-J of FIG. 38.

FIG. 41 illustrates cross-section K-K of FIG. 40.

FIGS. 44 and 45 illustrate various embodiments of cross-section L-L of FIG. 43.

FIG. 46 illustrates an alternate embodiment to the deployment configuration of FIG. 43.

FIG. 47 illustrates cross-section M-M of FIG. 46.

FIG. 48 illustrates a posterior view of an embodiment of the cooling element in a deployed configuration as shown in FIG. 47.

FIG. 49 shows an embodiment of using the cooling devices attached to the esophagus, pylorus and fundus.

FIG. 50 shows a cooling system utilizing a strain gauge attached or adhered to a stomach.

FIG. 51 shows a cooling system in which an intragastric sensor may be placed against a stomach serosal or mucosal surface and which transmits wirelessly to a controller.

FIGS. 52A and 52B illustrate a cooling system utilizing an esophageal activation sensor to detect esophageal distension and the various distension patterns which may be used to determine whether the cooling elements require activation, respectively.

FIG. 53 shows an example where a cooling unit may be activated by an external remote.

FIG. 54A illustrates a cooling element configured as a helical cooling element.

FIGS. 54B and 54C show top and side views of the controller and cooling unit.

FIG. 55 shows an example in which heat generated from the cooling element may be dissipated directly into the underlying tissue, e.g., the stomach, via the controller and cooling unit.

FIG. 56 shows another example in which the heat from the cooling element may be alternatively dissipated into other tissue structures, such as the bladder.

FIGS. 57A and 57B show examples of how a controller may be adhered or attached against the serosal or mucosal tissue layer of the stomach, respectively.

FIG. 58A illustrates another example of a cooling unit utilizing conductive heat transfer to dissipate generated thermal energy.

FIGS. 58B and 58C show various cross sectional areas of the thermal conduction line of the device of FIG. 58A.

FIG. 58D illustrates another example where a separate thermally conductive strap may be used to conduct heat away from the cooling element and into surrounding tissue structures.

Claims

1. A tissue temperature alteration apparatus comprising: a controller;a cooling element in data communication with the processor; anda digestive activation sensor in data communication with the controller;wherein the controller is configured to activate the cooling element when the digestive activation sensor transmits an activation data to the controller.

2. The apparatus of claim 1, wherein the digestive activation sensor comprises a stomach sensor.

3. The apparatus of claim 2, wherein the stomach sensor comprises an intragastic sensor.

4. The apparatus of claim 2, wherein the stomach sensor comprises a stomach surface sensor.

5. The apparatus of claim 1, wherein the activation sensor comprises an esophageal activation sensor.

6. The apparatus of claim 1, wherein the controller comprises a processor.

7. A tissue temperature alteration device comprising: An elongated body having a distal end;an anchoring mechanism on the distal end of the elongated body;a first channel along the elongated body;a second channel along the elongated body, wherein the first channel is in fluid communication with the second channel at the distal end; and

8. The device of claim 7, further comprising a third channel, wherein the third channel is in communication with the anchoring mechanism.

9. The device of claim 7, wherein the first channel is radially outside of the second channel.

10. The device of claim 7, wherein the anchoring mechanism is a balloon.

11. The device of claim 7, wherein the anchoring mechanism comprises radially extending arms.

12. The device of claim 7, wherein the third channel is in fluid communication with the anchoring mechanism.

13. The device of claim 7, wherein the third channel is in electrical communication with the anchoring mechanism.

14. The device of claim 13, further comprising a conductive wire in the third channel.

15. The device of claim 7, wherein the elongated body is resiliently deformable.

16. The device of claim 15, wherein the elongated body comprises a shape memory material.

17. The device of claim 7, wherein the elongated body is formed into a coiled configuration

18. The device of claim 17, wherein the elongated body is resiliently deformable.

19. The device of claim 18, wherein the elongated coil body comprises a shape memory material.

20. A method of deploying a heat transfer element into the epidural space comprising: anchoring the heat transfer element in the epidural space;advancing the heat transfer element into the epidural space such that the heat transfer element bends in a first direction; andflowing a fluid through the heat transfer element.

21. The method of claim 20, further comprising cooling the fluid.

22. The method of claim 20, further comprising heating the fluid.

23. The method of claim 20, further comprising additionally advancing the heat transfer element into the epidural space so that the heat transfer element bends in a second direction.

24. The method of claim 23, wherein the heat transfer element comprises a first body anchor and the method further comprises deploying the first body anchor.

25. The method of claim 24, further comprising additionally advancing the heat transfer element into the epidural space so that the heat transfer element bends in the first direction.

26. The method of claim 25, wherein the heat transfer element comprises a second body anchor and the method further comprises deploying the second body anchor.

27. A method of local pain relief from a first nerve comprising: implanting a heat transfer element adjacent to the first nerve, wherein the heat transfer element comprises a Peltier junction; andcontrolling the heat transfer of the heat transfer element.

28. The method of claim 27, wherein the first nerve is the femoral nerve.

29. A method of treating multiple sclerosis by cooling the spinal cord comprising: deploying a heat transfer element to the epidural space.

30. The method of claim 29, wherein deploying comprises advancing a catheter body into the epidural space.

31. The method of claim 30, wherein advancing a catheter body further comprises curving the catheter body in a first direction at a first length in the epidural space, and curving the catheter body in a second direction at a second length in the epidural space.

32. The method of claim 29, further comprising flowing cold fluid through the catheter body.

33. A method of minimally invasive deployment of a heat transfer element adjacent to a nerve, wherein the heat transfer element has a curved relaxed configuration, comprising: applying a straightening force on the heat transfer element;advancing the heat transfer element adjacent to the nerve; andremoving the straightening force from the heat transfer element.