System and method for site specific therapy

• US 6,537,241 B1
• Filed: 05/17/1999
• Issued: 03/25/2003
• Est. Priority Date: 08/08/1997
• Status: Expired due to Fees

• Current Assignee: Twin Star Medical, Inc.
• Original Assignee: Twin Star Medical, Inc.
• Inventors: Odland, Rick Mathew
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/313,341
• Time in Patent Office: 1,408 Days
• Field of Search: 604/4.01, 604/6.1, 604/6.11, 604/6.16, 604/8-10, 604/27, 604/28, 604/30-6, 604/38, 604/48, 604/500, 604/503-4, 604/65-67, 604/93, 604/118, 604/131, 604/149, 604/151, 604/163, 604/164-1-1, 604/164.13, 604/264, 604/523, 604/286, 604/540-41, 128/898, 138/111, 138/114-16, 138/118, 138/178, 600/562-63, 606/76, 606/77
• US Class Current: 604/9
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/26 and internal elements which are moving
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum

Abstract

A system, including catheter apparatus, and related method for performing site specific therapy. The catheter apparatus can include one or more semipermeable microcatheters (preferably in the form of hollow fibers) for use in performing site specific microdialysis. The system and method are particularly suited for use in addressing cerebral edema by affecting the osmolar relationship between fluids making up the brain tissue. Also disclosed is an apparatus having a delivery/recovery mechanism in the form of a pump reservoir and one or more catheters in the form of semipermeable microcatheters, for use in delivering and/or recovering fluid to and/or from a tissue site or for performing tissue engineering outside of the body. The apparatus can be used in a method to perform site specific microtherapy, including for the treatment of compartment syndrome or cerebral edema.

Claims

1. A system for performing site specific therapy of a tissue site, the system comprising one or more catheters, each comprising one or more semipermeable membranes in the form of hollow fibers adapted to be positioned within the tissue site, and a delivery/recovery mechanism for employing the catheter(s) to control the movement of bulk fluids within tissue portions in a manner that achieves a therapeutic effect, wherein the delivery/recovery mechanism comprises a source of negative hydrostatic pressure adapted to recover bulk fluids and/or water and permeant solutes through the semipermeable membranes and from the tissue site, and wherein the hollow fibers each provide a combination of strength, transport rate, and porosity suitable to provide improved fiber fluid recovery as compared to a conventional hollow fiber formed of regenerated cellulose membranes when evaluated in a test system comprising the fibers submerged in a physiologic fluid solution and subjected to negative 180 mm Hg.

2. A system according to claim 1 wherein the one or more catheters are selected from the group consisting of a single catheter comprising a single semipermeable membrane, a single catheter comprising a plurality of semipermeable membranes, a plurality of catheters each comprising a single semipermeable membrane, and a plurality of catheters, each comprising a plurality of semipermeable membranes.

3. An system according to claim 2 wherein one or more catheters comprise a plurality of semipermeable membranes provided in a bundle together with a guide wire.

4. A system according to claim 2 further comprising a component selected from ventriculostomy catheters, introducers, and guide wires.

5. A system according to claim 1 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less, and are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

6. A system according to claim 5 wherein the fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

7. A system according to claim 5 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

8. A system according to claim 1 wherein the system is adapted for use in the therapy of cerebral edema or compartment syndrome.

9. A system according to claim 1 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less.

10. A system according to claim 1 wherein the hollow fibers are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

11. A system according to claim 1 wherein the hollow fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

12. A system according to claim 1 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

13. A system according to claim 1 wherein the hollow fibers are prepared from polyacrylonitrile and provide fiber fluid recovery of at least 1.86 uL/min/cm.

14. A system according to claim 1 wherein the hollow fibers are prepared from polysulfone and provide a fiber fluid recovery of at least 7.29 uL/min/cm.

15. A method for performing site specific therapy of a tissue site, the method comprising the steps of a) providing a system comprising one or more catheters, each comprising one or more semipermeable membranes in the form of hollow fibers, and each adapted to be positioned within the tissue sites and a delivery/recovery mechanism for employing the catheter(s) to control the movement of bulk fluids and/or active fluid components, within tissue portions, b) positioning the catheter(s) within the tissue site, and c) operating the mechanism in order to control the movement of bulk fluids and/or active fluid components, wherein the delivery/recovery mechanism comprises a source of negative hydrostatic pressure adapted to recover bulk fluids and/or water and permeant solutes through the semipermeable membranes and from the tissue site, wherein the hollow fibers each provide a combination of strength, transport rate, and porosity suitable to provide improved fiber fluid recovery as compared to a conventional hollow fiber formed of regenerated cellulose membrane when evaluated in a test system comprising the fibers submerged in a physiologic fluid solution and subjected to negative 180 mm Hg.

16. A method according to claim 15 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less, and are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

17. A method according to claim 16 wherein the fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

18. A method according to claim 16 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

19. A method according to claim 15 wherein the system is adapted for use in the therapy of cerebral edema or compartment syndrome.

20. A method according to claim 15 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less.

21. A method according to claim 15 wherein the hollow fibers are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

22. A method according to claim 15 wherein the hollow fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

23. A method according t claim 15 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

24. A method according to claim 15 wherein the hollow fibers are prepared from polyacrylonitrile and provide fiber fluid recovery of at least 1.86 uL/min/cm.

25. A method according to claim 15 wherein the hollow fibers are prepared from polysulfone and provide a fiber fluid recovery of at least 7.29 uL/min/cm.

26. A method for performing site specific therapy of a tissue site, the method comprising the steps of:

a) providing a system comprising one or more catheters, each comprising one or more semipermeable membranes in the form of hollow fibers, and each adapted to be positioned within the tissue site and a delivery/recovery mechanism for employing the catheter(s) to control the movement of bulk fluids and/or water and permeant solutes within tissue site, wherein the system is adapted for use in the therapy of compartment syndrome or cerebral edema,

b) positioning the catheter(s) within the tissue site exhibiting compartment syndrome or cerebral edema, and

c) operating the mechanism in order to control the movement of bulk fluids and/or water and permeant solutes, wherein

the delivery/recovery mechanism comprises a source of negative hydrostatic pressure adapted to recover bulk fluids and/or water and permeant solutes from within the tissue site.

27. A method according to claim 26 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less, and are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

28. A method according to claim 27 wherein the fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

29. A method according to claim 27 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

30. A method according to claim 28 wherein the rate of fluid removal can be altered by making adjustments to the negative pressure applied to the combined system.

31. A method according to claim 26 wherein the catheters are used for the recovery of bulk fluid from the parenchyma.

32. A method according to claim 26 wherein the system is adapted for use in the therapy of cerebral edema or compartment syndrome.

33. A method according to claim 26 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less.

34. A method according to claim 26 wherein the hollow fibers are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

35. A method according to claim 26 wherein the hollow fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

36. A method according to claim 26 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

37. A method according to claim 26 wherein the hollow fibers are prepared from polyacrylonitrile and provide fiber fluid recovery of at least 1.86 uL/min/cm.

38. A method according to claim 26 wherein the hollow fibers are prepared from polysulfone and provide a fiber fluid recovery of at least 7.29 uL/min/cm.

39. A method for performing site specific therapy in order to treat cerebral edema, the method comprising the steps of:

a) providing a system comprising one or more catheters, in the form of a plurality of semipermeable membranes adapted to be positioned within the brain parenchyma and a delivery/recovery mechanism for employing the hollow fibers to control the movement of bulk fluids and/or water and permeant solutes within the parenchyma,

b) positioning the hollow fibers within the parenchyma, and

c) operating the mechanism by applying a source of negative hydrostatic pressure to recover bulk fluids and/or water and permeant solutes through the hollow fibers and from within the tissue site in a manner that achieves a therapeutic effect.

40. A method according to claim 39 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less, and are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

41. A method according to claim 40 wherein the fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

42. A method according to claim 40 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

43. A method according to claim 39 wherein the hollow fibers are provided in a bundle together with a guide wire.

44. A method according to claim 39 wherein the semipermeable membranes are selected from dual hollow fibers, a bundle of multiple hollow fibers, coaxial fibers, and fibers provided in a loop configuration.

45. A method according to claim 39 wherein the system is adapted for use in the therapy of cerebral edema or compartment syndrome.

46. A method according to claim 39 wherein the semipermeable membranes are each provided in the form of hollow fibers having an outer diameter of about 3 mm or less.

47. A method according to claim 39 wherein the hollow fibers are prepared from materials selected from the group consisting of polyacrylonitrile and polysulfone.

48. A method according to claim 39 wherein the hollow fibers are prepared from polyacrylonitrile and provide a molecular weight cut off of at least 50,000 daltons.

49. A method according to claim 39 wherein the hollow fibers are prepared from polysulfone and provide a molecular weight cut off of at least 60,000 daltons.

50. A method according to claim 39 wherein the hollow fibers are prepared from polyacrylonitrile and provide fiber fluid recovery of at least 1.86 uL/min/cm.

51. A method according to claim 39 wherein the hollow fibers are prepared from polysulfone and provide a fiber fluid recovery of at least 7.29 uL/min/cm.