System for treating tissue swelling

• US 20030181824A1
• Filed: 03/22/2002
• Published: 09/25/2003
• Est. Priority Date: 03/22/2002
• Status: Active Grant

• Current Assignee: Twin Star Medical, Inc.
• Original Assignee: Twin Star Medical, Inc.
• Inventors: Odland, Rick Mathew
• Granted Patent: US 6,942,633 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• 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 method for performing site specific therapy to alleviate tissue swelling, involving the placement and use of recovery catheters having semipermeable membranes adapted to recover bulk fluid or fluid components from a tissue site. Fluid recovery can be accomplished by the delivery of a hydratable medium to the membranes, under conditions suitable to permit fluid or components to pass through the membranes in order to hydrate the medium, which is then removed from the tissue site. The method and system can also include the use of components for monitoring the progress of the system, and components for introducing a recovery catheter to a tissue site.

Claims

1. A therapeutic system for the treatment of tissue swelling, the system comprising:

a) one or more recovery catheters comprising semipermeable membranes,

b) recovery components for recovering bulk fluid or fluid components through the semipermeable membranes and from the tissue site, in order to achieve a therapeutic result, preferably in the form of a reduction in swelling, and either

c) a hydratable medium adapted to be used directly or indirectly with the tissue site and within the semipermeable membrane(s) under conditions suitable to remove water from the tissue site in the form of hydrated medium, or

d) monitoring components associated in an integral manner with the recovery membrane(s).

2. A system according to claim 1 wherein the catheter is implantable within the body and the system comprises both d) and e).

3. A system according to claim 1 wherein the hydratable medium comprises a gas.

4. A system according to claim 2 wherein the hydratable medium comprises a gas.

5. A system according to claim 1 wherein the recovery catheters comprise a plurality of hollow fibers formed of semipermeable membranes.

6. A system according to claim 5 wherein the fibers are formed of materials selected from the group consisting of polyacrylonitrile, polyethersulfone, cellulose and polysulfone.

7. A system according to claim 6 wherein the fibers have outer diameters between about 0.1 mm and about 10 mm and provide permeability in the range of from about 1 kD to about 200 microns.

8. A system according to claim 7 wherein the outer diameters are between about 0.3 mm and about 1 mm, and provide permeability in the range from about 50 kD and about one micron.

9. A system according to claim 8 wherein the introducing components are selected from the group consisting of introducers, sytlets, and trocars, and combinations thereof.

10. A system according to claim 1 wherein the recovery components is adapted to control the movement of fluid by means selected from the group consisting of 1) the movement of interstitial fluid within the tissue itself, 2) the movement of fluid from the tissue and into a semipermeable membrane(s) positioned therein, and 3) the movement of fluid from or within the lumen of the semipermeable catheter(s).

11. A system according to claim 10 wherein the recovery components comprises a combination of negative hydrostatic pressure, for removal of fluid from the lumen of the semipermeable catheters(s) and diffusion, for the movement of fluid from the tissue and into the semipermeable membrane(s).

12. A system according to claim 11 wherein the diffusion is accomplished by the delivery of a dehydrated medium into the semipermeable membrane(s) under conditions suitable to permit the tissue to hydrate the medium upon the passage of water vapor through the membrane walls.

13. A system according to claim 12 wherein the hydratable medium comprises a dehydrated gas.

14. A system according to claim 1 wherein the monitoring components comprises components adapted to qualitatively and/or quantitatively assess one or more parameters in a substantially real time fashion.

15. A system according to claim 14 wherein the parameters are selected from the group consisting of physiologic parameters associated with the tissue itself and performance parameters associated with the function of the system or its components.

16. A system according to claim 15 wherein the physiologic parameters are selected from the group consisting of tissue pressure, blood flow, hydration, temperature, pH, and biochemical parameters.

17. A system according to claim 16 wherein the monitoring components are associated with the system of this invention, in that that one or more components of the monitoring components are physically and/or functionally integrated with the placement and/or operation of the semipermeable membrane component.

18. A system according to claim 17 wherein the system comprises the delivery of a hydratable medium in the form of a hydratable gas to the recovery catheters and further comprises the use of a pressure monitor component associated with the recovery catheters in a single, implantable catheter assembly.

19. A system according to claim 18 wherein the recovery catheters comprise a plurality of hollow fibers formed of semipermeable membranes selected from the group consisting of polyacrylonitrile, polyethersulfone, cellulose and polysulfone, each having an outer diameters between about 0.1 mm and about 10 mm and providing permeability in the range of from about 1 kD to about 200 microns.

20. A system according to claim 19 wherein the system further comprises a sterile kit of introducer components selected from the group consisting of burr hole drill adapted to form a hole within the skull of a patient exhibiting cerebral edema, a tunneling trocar adapted to provide a path for the catheter assembly to pass through the burr hole and to a tissue site, and a placement stylet adapted to fit within the catheter assembly in order to position it within the tissue site.

21. A catheter assembly, provided in sterile form and adapted to be used in the system of claim 1.

22. A catheter assembly according to claim 21, wherein the catheter is implantable within the body and the assembly is provided in two or more packages, including one package comprising one or more components for use as introducing components and a second package comprising implantable semipermeable membranes, in combination with either a lumen for delivering hydratable medium or a component of a monitoring device, or both.

24. A method of treating a tissue site exhibiting swell, the method comprising the step of providing a system according to claim 1 and employing the system to remove fluid from the tissue site exhibiting swelling, or from a tissue site physiologically associated with the tissue site exhibiting swelling.

25. A method according to claim 24 wherein the system is adapted for the treatment of compartment syndrome.

26. A method according to claim 24 wherein the system is adapted for the treatment of cerebral edema.

27. A method according to claim 24 wherein the recovery catheters comprise a plurality of hollow fibers formed of semipermeable membranes.

28. A method according to claim 27 wherein the fibers are formed of materials selected from the group consisting of polyacrylonitrile, polyethersulfone, cellulose and polysulfone.

29. A method according to claim 28 wherein the fibers have outer diameters between about 0.1 mm and about 10 mm and provide permeability in the range of from about 1 kD to about 200 microns.

30. A method according to claim 29 wherein the outer diameters are between about 0.3 mm and about 1 mm, and provide permeability in the range from about 50 kD and about one micron.

23. A therapeutic system for the treatment of tissue swelling, the system comprising:

a) a plurality of recovery catheters comprising semipermeable membranes,

b) introducing components adapted to position the recovery catheter(s) within a tissue site exhibiting swelling,

c) recovery components for recovering bulk fluid or fluid components through the semipermeable membranes and from the tissue site, in order to achieve a reduction in swelling,

d) a hydratable medium comprising a hydratable gas adapted to be delivered to the tissue site and within the semipermeable membrane(s) under conditions suitable to remove water from the tissue site in the form of hydrated medium, and

e) monitoring components associated with the recovery catheter(s) and adapted to monitor one or more physiologic parameters selected from the group consisting of tissue pressure, blood flow, hydration, temperature, pH, and biochemical parameters,

wherein the system is adapted for the treatment of compartment syndrome or cerebral edema,

the recovery components comprise a combination of negative hydrostatic pressure and diffusion adapted to control the movement of fluid from the tissue and into the semipermeable membranes, and negative hydrostatic pressure adapted to remove fluid from within the lumen of the membranes and from the tissue site.

31. A method of preparing a therapeutic system for the treatment of tissue swelling, the method comprising the steps of assembling a system comprising:

a) one or more recovery catheters comprising semipermeable membranes,

b) recovery components for recovering bulk fluid or fluid components (e.g., water) through the semipermeable membranes and from the tissue site, in order to achieve a therapeutic result, preferably in the form of a reduction in swelling, and either

c) a hydratable medium adapted to be delivered to the tissue site and within the semipermeable membrane(s) under conditions suitable to remove water from the tissue site in the form of hydrated medium, or

d) monitoring components associated with the recovery catheter(s).

32. A method according to claim 31 wherein the system comprises both d) and e).

33. A method according to claim 31 wherein the system is adapted for the treatment of compartment syndrome.

34. A method according to claim 31 wherein the system is adapted for the treatment of cerebral edema.

35. A method according to claim 31 wherein the recovery catheters comprise a plurality of hollow fibers formed of semipermeable membranes.