System for treating tissue swelling

• US 6,942,634 B2
• Filed: 10/17/2002
• Issued: 09/13/2005
• Est. Priority Date: 03/22/2002
• Status: Expired due to Fees

• Current Assignee: Twin Star Medical, Inc.
• Original Assignee: Twin Star Medical, Inc.
• Inventors: Odland, Rick Mathew
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/273,376
• Publication Number:
  US 20030187367A1
• Time in Patent Office: 1,062 Days
• Field of Search: 604/4.01, 604/601, 604 501- 504, 604/6.07, 604/6.11, 604/6.16, 604/19, 604 27- 8, 604/30, 604 23- 4, 604/48, 604/500, 604503-508, 604/65, 738/63, 738/632.1, 738/633.1, 738/637.1, 738/638.1, 128/898, 435/1.1, 435/1.2, 210/645, 210650- 52, 210/739, 210/762, 210/790, 210/85, 210/90, 210/194, 2101951-1952, 210252- 3, 210/255, 2102571-2572, 210258-260, 210/321.6, 210/321.65, 21032171-32172, 21032178-32179, 210/321.8, 210/322, 2103231-3232, 210/500.1, 210/348, 210/500.21, 210/500.23
• US Class Current: 604/6.09
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A system and related methods and components for treating tissue swelling, and particularly swelling associated with cerebral edema, compartment syndrome, and congestive heart failure, by the use of water removal therapy, in order to remove only water from biological fluids. Included also is a system for such use that incorporates one or more monitors, optionally in addition to the use of water removal therapy. By removing only water, all other biologic agents, including essentially all solutes and formed blood elements (such as cells) are increased in concentration in the remaining bodily fluid(s). WRT can be applied to several clinical conditions in which there is an excess of water, and is ideally used in an extracorporeal fashion, in combination with other functions and related components as well, including ultrafiltration.

Claims

1. A method of treating tissue swelling, the method comprising the step of employing one or more semipermeable membranes in combination with a hydratable medium in order to remove substantially only water through the semipermeable membrane(s) and from a biological fluid associated with the swelling, wherein the hydratable medium comprises a hydratable gas, and further comprising the use of one or more semipermeable membranes in order to perform ultrafiltration on the same or different biological fluid, in order to remove both water and permeable solutes from the biological fluid, and either in series or parallel with the water removal step.

2. A method according to claim 1 wherein the method is used to treat swelling associated with congestive heart failure, and provides a desired combination of ultrafiltration to remove water and permeable solutes, together with water removal therapy to remove substantially only water.

3. A method according to claim 2 wherein both ultrafiltration and water removal therapy are performed in an extracorporeal fashion.

4. A method according to claim 3 comprising respective extracorporeal cartridges in which both ultrafiltration and water removal are performed in parallel on different aliquots of blood.

5. A method according to claim 4 wherein the cartridges each comprise a plurality of hollow fibers together with extraluminal and intraluminal flow paths, the hydratable medium comprises a desiccated gas delivered to the intraluminal flow path, and the biological fluid comprises blood or ultrafiltrate delivered to the extraluminal flow path.

6. A method according to claim 5 wherein the fibers are formed of materials selected from the group consisting of polytetrafluoroethylene, polypropylene, polyvinylidene difluoride, acrilic copolymers, polyacrylonitrile, polyethersulfone, cellulose and polysulfone.

7. A method according to claim 4 wherein the cartridges each comprise a plurality of hollow fibers together with extraluminal and intraluminal flow paths, the hydratable medium comprises a desiccated gas delivered to the extraluminal flow path, and the biological fluid comprises blood or ultrafiltrate delivered to the intraluminal flow path.

8. A method according to claim 3 wherein the method is used to treat swelling associated with congestive heart failure, acute renal failure, chronic renal failure, hyponatremia, or water excess syndrome.

9. A method according to claim 3 further comprising the step of reinfusing the treated fluid with one or more components prior to return to the body.

10. A method according to claim 3 comprising respective extracorporeal cartridges in which both ultrafiltration and water removal are performed in series, with water removal therapy performed following ultrafiltration, and on at least a portion of the ultrafiltrate.

11. A method according to claim 1 wherein the method comprises an arteriovenous method based on a pressure differential between arterial and venous blood to drive blood through a water therapy removal cartridge.

12. A method of treating tissue swelling, the method comprising the step of employing one or more semipermeable membranes in combination with a hydratable medium in order to remove substantially only water through the semipermeable membrane(s) and from a biological fluid associated with the swelling wherein the method comprises a venovenous method based upon the pumping action of vaporization itself.

13. A method of treating tissue swelling, the method comprising the step of employing one or more semipermeable membranes in combination with a hydratable gas in order to remove substantially only water through the semipermeable membrane(s) and from a biological fluid associated with the swelling.

14. A method according to claim 13, further comprising the use of one or more semipermeable membranes in order to perform ultrafiltration on the same or different biological fluid, in order to remove both water and permeable solutes from the biological fluid, and either in series or parallel with the water removal step.

15. A method according to claim 14 wherein the tissue comprises the heart.

16. A method according to claim 15 wherein both ultrafiltration and water removal therapy are performed in an extracorporeal fashion.

17. A method according to claim 14 wherein the water removal and ultrafiltration are performed on the same biological fluid.

18. A method according to claim 13 wherein the semipermeable membranes are provided in the form of one or more cartridges that each comprise a plurality of hollow fibers together with extraluminal and intraluminal flow paths.

19. A method according to claim 18 wherein the hydratable gas is delivered to the intraluminal flow path, and the biological fluid is delivered to the extraluminal flow path.

20. A method according to claim 18 wherein the hydratable gas is delivered to the extraluminal flow path, and the biological fluid is delivered to the intraluminal flow path.

21. A method according to claim 13 wherein the one or more semipermeable membranes are provided in the form of hollow fibers.

22. A method according to claim 21 wherein the hollow fiber provides a permeability in the range of from about 1 kD to about 200 microns.

23. A method according to claim 22 wherein the permeability is between about 10 kD to about 10 microns.

24. A method according claim 23 wherein the permeability is between about 50 kD and about one micron.

25. A method according to claim 21 wherein the fibers are formed of materials selected from the group consisting of polytetrafluoroethylene, polypropylene, polyvinylidene difluoride, acrylic copolymers, polyacrylonitrile, polyethersulfone, cellulose and polysulfone.

26. A method according to claim 21 wherein the length of the fibers is between about 1 cm to about 100 cm.

27. A method according to claim 26 wherein the length is between about 5 cm and about 20 cm.

28. A method according to claim 21 wherein the fibers have an inner diameter (ID) of between about 50 microns to 5000 microns.

29. A method according to claim 28 wherein the inner diameter is between about 100 microns to about 1000 microns.

30. A method according to claim 13 further comprising the use of one or more monitoring components physically and/or functionally integrated with the placement and/or operation of the semipermeable membrane component.

31. A method according to claim 13 wherein the semipermeable membranes and hydratable gas are used in an extracorporeal fashion.

32. A method according to claim 31 wherein the semipermeable membranes are provided in the form of hollow fibers.

33. A method according to claim 32 wherein the hydratable gas is provided either within or surrounding the hollow fiber, in order to withdraw water vapor from biological fluid that is contacted with the opposite fiber surface.

34. A method according to claim 13 wherein the semipermeable membrane is employed in a position selected from the group consisting of:

a) positioned directly within the tissue exhibiting swelling itself, b) positioned within a remote tissue having a indirect physiologic effect on the tissue exhibiting swelling, or c) positioned externally to the body itself in the form of a remote unit functionally connected to the body by a fluid flow circuit, and in turn to the swollen tissue site.

35. A method according to claim 13 wherein the hydratable gas is selected from dessicated or dehydrated air, carbon dioxide, nitrogen, and helium.

36. A method according to claim 13 wherein the flow of hydratable medium can be adjusted to in order to achieve water removal at any desired rate and and/or total amount.

37. A method according to claim 36 wherein flow of hydratable gas within the fibers is between about 1 l/mm to about 100 l/mm per 1000 cm² of fiber surface area.

38. A method according to claim 37 wherein the flow is between about 2 l/mm and about 25 l/mm per 1000 cm² of fiber surface area.

39. A method according to claim 36 wherein the water removal rate from the biological fluid is between about 100 ml/hr to about 500 ml/hr.

40. An apparatus for treating tissue swelling, comprising one or more semipermeable membranes in combination with a hydratable gas in order to remove substantially only water through the semipermeable membrane(s) and from a biological fluid associated with swelling in the heart.

41. An apparatus according to claim 40 wherein the one or more semipermeable membranes are in the form of hollow fibers.

42. An apparatus according to claim 41 wherein the fibers are formed of materials selected from the group consisting of polytetrafluoroethylene, polypropylene, polyvinylidene difluoride, acrylic copolymers, polyacrylonitrile, polyethersulfone, cellulose and polysulfone.