Method and apparatus for peritoneal hypothermia and/or resuscitation

• US 8,672,884 B2
• Filed: 10/23/2006
• Issued: 03/18/2014
• Est. Priority Date: 10/21/2005
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Velomedix, Inc.
• Inventors: Mangrum, Shane, Burnett, Daniel R, Blanton, Jared C
• Primary Examiner(s): Flick, Jason
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US11/552,090
• Publication Number:
  US 20070106247A1
• Time in Patent Office: 2,703 Days
• Field of Search: 604113-114, 604/26, 604/29, 604/508, 604140-147
• US Class Current: 604/113
• CPC Class Codes: A61F 2007/0094 using a remote control
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Embodiments of the invention provide apparatus, systems and methods for introducing fluids into a body cavity for hypothermic, resuscitative, or other treatment. One embodiment provides an apparatus for introducing fluids into a peritoneal cavity comprising an access device for insertion into subcutaneous tissue, an infusion member and an advancement member. The access device includes a lumen, a proximal end, a tissue penetrating distal end and a stop for controlling the depth of the distal end into tissue. The infusion member includes an infusion lumen, a removal lumen and at least one sensor and is advanceable from a lumen of the access device into the peritoneal cavity. The advancement member is removably positionable in an infusion member lumen and has sufficient column strength to advance the infusion member tip through abdominal wall tissue into the peritoneal cavity. When the advancement member is removed, the infusion member tip is substantially atraumatic.

Claims

1. A method of inducing hypothermia in a patient, the method comprising:

inserting an access device a controlled depth into an abdominal wall of the patient;

determining entry point into the peritoneal cavity utilizing a sensor output;

advancing an infusion member through the access device and into the peritoneal cavity of the patient without injuring an organ in the peritoneal cavity;

monitoring a temperature of the patient at a selected location;

infusing a hypothermic infusate solution into the peritoneal cavity through the access device or an infusion member positioned within the access device, wherein an infusion parameter is controlled utilizing the monitored temperature;

cooling tissue in the peritoneal cavity with the hypothermic solution; and

reducing the temperature of the patient to a selected temperature.

2. The method of claim 1, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of coronary ischemic tissue injury resulting from myocardial infarction, cardiac arrest or other coronary ischemic event.

3. The method of claim 1, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of cerebral ischemic tissue injury resulting from stroke, cardiac arrest or other cerebral ischemic event.

4. The method of claim 1, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of ischemic tissue injury in a tissue extremity.

5. The method of claim 1, wherein at least one of a rate of infusion or cooling is titrated to reduce an inflammatory response resulting from a surgical procedure.

6. The method of claim 5, wherein the surgical procedure is a cardiovascular procedure, an open heart procedure, a valve repair or replacement procedure, an aneurysm repair procedure, a cerebral surgical procedure, a renal procedure or a hepatic surgical procedure.

7. The method of claim 1, further comprising:

inflating a peritoneal cavity so as to expand an exposed surface area of a peritoneal cavity organ; and

flowing the hypothermic fluid over the exposed surface area of the peritoneal cavity organ so as to exchange heat or gas with a peritoneal cavity organ.

8. The method of claim 1, wherein the infusion member is advanced using an advancement member positioned within the infusion member.

9. The method of claim 8, further comprising:

removing the advancement member once the infusion member has been positioned in the peritoneal cavity.

10. The method of claim 1, wherein a temperature of the solution is in the range of 10 to 20°

C.

11. The method of claim 1, wherein the selected temperature is in the range of about 20 to 35°

C.

12. The method of claim 1, wherein the infusion comprises infusing a bolus of solution.

13. The method of claim 12, wherein a volume of the bolus is in the range of about 0.5 to 3 liters.

14. The method of claim 12, wherein the infusion further comprises infusing fluid at a controlled rate after completion of the bolus infusion.

15. The method of claim 14, wherein the controlled rate is controlled to maintain the core temperature of the patient at a hypothermic level.

16. The method of claim 1, wherein at least one of the rate or volume of infusate is configured to increase a mean patient blood pressure.

17. The method of claim 1, wherein the infusion parameter is at least one of a flow rate, a pressure, a total infused volume, an inflow duty cycle or a hypothermic solution temperature.

18. The method of claim 1, wherein the selected location is at least one of a tympanic membrane, an intravenous site, an epidermal site, a subcutaneous site or an oral site.

19. The method of claim 1, wherein the selected location includes a plurality of locations and the monitored temperature comprises a composite temperature from the plurality of locations.

20. The method of claim 1, wherein the infusate is infused using a driving force from at least one of a compressed gas source, a gravitational head pressure or a pump.

21. The method of claim 20, wherein the compressed gas source is an oxygen source which is configured to oxygenate the infusate solution.

22. The method of claim 1, wherein the entry point is determined by monitoring a flow rate of infusate solution into the peritoneal cavity.

23. The method of claim 1, further comprising:

signaling an entry point event to a medical practitioner performing the method.

24. The method of claim 1, wherein the depth of insertion of the access device into the peritoneal cavity is controlled.

25. The method of claim 24, wherein the insertion depth is controlled through use of a stop positioned on the access device.

26. The method of claim 1, further comprising:

monitoring a pressure within the peritoneal cavity or the infusion member; and

titrating the infusate flow rate responsive to the monitored pressure.

27. The method of claim 26, wherein the monitored pressure is utilized to prevent over-filling of the peritoneal cavity.

28. The method of claim 26, wherein the infusate flow rate is titrated responsive to the monitored pressure exceeding a threshold or a rate of increase.

29. The method of claim 1, wherein the access device has a tissue penetrating configuration and a non-tissue penetrating safety configuration.

30. The method of claim 29, wherein the access device assumes the safety configuration after insertion through the abdominal wall.

31. The method of claim 29, wherein the access device includes a slidable sheath that slides over a tissue penetrating portion of the introducer to achieve the safety configuration.

32. The method of claim 29, wherein the access device includes a shearable tissue penetrating portion which when sheared assumes the safety configuration.

33. The method of claim 29, wherein the safety configuration is achieved by pressurizing the access device.

34. The method of claim 27, further comprising:

inserting the access device through tissue in the tissue penetrating configuration; and

converting to the safety configuration when a distal portion of the access device penetrates the distal side of the abdominal wall.

35. The method of claim 1, further comprising:

withdrawing at least a portion of the infusate from the peritoneal cavity.

36. The method of claim 35, further comprising:

utilizing the withdrawn solution as a heat sink for cooling the infusate solution infused into the peritoneal cavity.

37. The method of claim 36, wherein cooling is performed using a peltier effect device.

38. The method of claim 35, wherein the infusate is withdrawn using a vacuum pressure.

39. The method of claim 35, wherein the infusate is withdrawn at the same access point in the abdominal wall used for infusion.

40. The method of claim 35, wherein the infusate is withdrawn responsive to at least one of an infusion inflow rate, a peritoneal pressure, or a peritoneal temperature.

41. The method of claim 35, wherein at least one of the infusion or withdrawal of the infusate is pulsated.

42. The method of claim 41, wherein the pulsation is synchronized to a heart rate or a respiration rate.

43. The method of claim 35, wherein the infusion and the withdrawal of the infusate are performed in substantially sequential periods.

44. The method of claim 35, wherein the duration and waveform of the infusion withdrawal are configured to optimize at least one of heat transfer with the peritoneal organs, rate of body cooling to a selected core temperature, maintenance of body core temperature at the selected temperature and oxygenation of the peritoneal organs.

45. The method of claim 41, wherein there is an interval between each period of infusion and withdrawal.

46. The method of claim 1, further comprising:

oxygenating the infusate solution before infusion into the patient.

47. The method of claim 46, further comprising:

utilizing the infusate solution to diffuse sufficient oxygen through the peritoneal tissue to at least partially meet the oxygen requirements of the patient.

48. The method of claim 46, wherein the infusate solution comprises a fluorocarbon.