Process and device to reduce interstitial fluid pressure in tissue

• US 5,484,399 A
• Filed: 01/13/1994
• Issued: 01/16/1996
• Est. Priority Date: 02/27/1992
• Status: Expired due to Fees

• Current Assignee: Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
• Original Assignee: Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
• Inventors: Arbit, Ehud, Lee, Jongbin, DiResta, Gene R.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/181,356
• Time in Patent Office: 733 Days
• Field of Search: 604/19, 604/21, 604/49, 604/173, 604/902, 128/748
• US Class Current: 604/21
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• 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 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure

Abstract

A method and apparatus are provided for reducing interstitial fluid pressure in tissues, particularly in tumors, by applying suction to the interior of the tissue. The method comprises inserting into the tissue one or more needle-like, elongated tubes, each having at least one hole at or near the end that is inserted into the tissue and each having means to apply suction to the protruding end. The reduced pressure produced inside the tissue by this method is useful to: facilitate penetration by drugs and therapeutic macromolecules into the tissue; enhance radiation treatment of tumors by increasing the oxygen supply in the tumor; and remove fluid to reduce edema in tissues, e.g. brain edema. Means may be provided to measure the pressure within the tissue and to use this measurement to control the suction applied to the tissue through the tubes.

Claims

1. An apparatus for reducing interstitial fluid pressure in a tumor comprising:

an aspiration device having a plurality of aspiration tubes connected to a manifold means, each of said tubes having a plurality of aspiration holes;

means for connecting the manifold means to a suction source for creating suction inside the aspiration tubes, having a pressure value less than the interstitial fluid pressure but having a pressure value which will not result in removing or damaging the tumor, to thereby reduce the interstitial fluid pressure inside the tumor when the tubes are located in the tumor; and

a measurement probe mounted to one of the plurality of aspiration tubes for measuring the interstitial fluid pressure within the tumor, wherein an aperture of the measurement probe is spaced apart from the aspiration tube to which it is mounted at a sufficient distance so that a pressure measured by the measurement probe is not substantially affected by the suction present at the plurality of aspiration holes of the plurality of aspiration tubes.

2. The apparatus according to claim 1, further comprising:

control means connected to said measurement probe; and

a suction source operatively connected to said control means being responsive to a signal sent therefrom, said suction source being adapted to regulate the suction created in dependence on the signal sent from the control means, said signal being indicative of the pressure measured by the measurement probe, wherein the suction has a pressure value less than the interstitial fluid pressure, to thereby reduce the interstitial fluid pressure within the tissue.

3. A process for reducing interstitial fluid pressure in a tumor comprising:

placing an aspiration device within the tumor; and

applying, to the aspiration device, suction having a pressure value less than the interstitial fluid pressure but having a pressure value which will not result in removing or damaging the tumor, to thereby reduce interstitial fluid pressure within the tumor,

wherein the step of placing an aspiration device comprises locating within the tumor an aspiration device of diameter not greater than that of an 18 gauge needle having a plurality of aspiration holes, and wherein the pressure value of the suction applied in the step of applying suction is greater than -100 mmHg.

4. The process according to claim 3, wherein the step of placing an aspiration device comprises locating an aspiration device having a plurality of aspiration tubes for locating in the tumor, each tube having at least one aspiration hole.

5. The process according to claim 4, wherein each tube has a plurality of aspiration holes.

6. The process of claim 3, used in conjunction with chemotherapy to enhance treatment of inoperable tumors.

7. The process of claim 3, used in conjunction with radiation therapy to enhance treatment of inoperable tumors.

8. A process for reducing interstitial fluid pressure in a tumor comprising:

placing an aspiration device within the tumor;

applying, to the aspiration device, suction having a pressure value less than the interstitial fluid pressure but having a pressure value which will not result in removing or damaging the tumor, to thereby reduce interstitial fluid pressure within the tumor;

measuring the interstitial fluid pressure within the tumor; and

regulating suction applied to the aspiration device in dependence on the measured interstitial pressure wherein the suction has a pressure value less than the interstitial fluid pressure but has a pressure value which will not result in removing or damaging the tumor, to thereby reduce the interstitial fluid pressure within the tumor.

9. A process for reducing interstitial fluid pressure in a tumor comprising:

placing an aspiration device within the tumor; and

applying, to the aspiration device, suction having a pressure value less than the interstitial fluid pressure but having a pressure value which will not result in removing or damaging the tumor, to thereby reduce interstitial fluid pressure within the tumor,

wherein the aspiration device has means for measuring the interstitial fluid pressure, and wherein through control means connected to the means for measuring the interstitial fluid pressure and suction source, the suction created may be regulated in dependence on the measured interstitial fluid pressure so that the suction is maintained at a pressure value below the interstitial fluid pressure.