Device for chronic measurement of internal body pressure

• US 4,846,191 A
• Filed: 05/27/1988
• Issued: 07/11/1989
• Est. Priority Date: 05/27/1988
• Status: Expired due to Term

• Current Assignee: Transoma Medical, Inc.
• Original Assignee: Data Sciences Incorporated
• Inventors: Miller, Jonathan T., Brockway, Brian P., Mills, Perry A.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Sykes, Angela D.
• Application Number:
  US07/199,697
• Time in Patent Office: 410 Days
• Field of Search: 128/672-675, 128/748, 128/903, 73/706-707
• US Class Current: 600/561
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: G01L 19/0061 Electrical connection means
• CPC Class Codes: G01L 19/0084 to the outside of the housing other details about the housing see G01L19/14
• CPC Class Codes: G01L 19/141 Monolithic housings, e.g. molded or one-piece housings
• CPC Class Codes: G01L 19/147 Details about the mounting of the sensor to support or covering means
• CPC Class Codes: H01L 2224/48091 Arched
• CPC Class Codes: H01L 2924/00014 the subject-matter covered by the group, the symbol of which is combined with the symbol of this group, being disclosed without further technical details
• CPC Class Codes: H01L 2924/16152 Cap comprising a cavity for hosting the device, e.g. U-shaped cap
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

Measurement of a physiological pressure is accomplished by placement of a pressure transmitting catheter within a blood vessel or other structure within which pressure is to be measured. The catheter is blood-compatible, capable of withstanding handling during distribution and implantation, and provides adequate pressure transmission frequency response in a variety of applications. The catheter, which includes a hollow flexible tube filled with a low viscosity fluid and having a plug of a gel-like material at its distal end, transmits the pressure signal to a solid-state transducer which is typically connected to amplifying electronics and an implantable radio-transmitter capable of relaying the pressure information from within the body to a radio receiver located external to the body.

Claims

1. A pressure measurement device for measuring a physiological pressure, the device comprising:

pressure transducer means for providing a signal which varies as a function of pressure;

pressure transmitting catheter means for transmitting the physiological pressure to the pressure transducer means, the pressure transmitting catheter means including a hollow flexible tube having a first end for placement at a position at which the physiological pressure is to be measured, a second end in communication with the pressure transducer means, a gel-like material positioned in the tube at the first end, and a liquid which fills the tube and interfaces with the pressure transducer means for transmitting pressure from the gel-like material to the pressure transducer means.

2. The pressure measurement device of claim 1 wherein the liquid is a hydrophobic liquid.

3. The pressure measurement device of claim 2 wherein the hydrophobic liquid is an inert fluorinated hydrocarbon.

4. The pressure measurement device of claim 1 wherein the liquid is substantially insoluble in the gel-like material.

5. The pressure measurement device of claim 1 wherein the liquid has a lower viscosity than the gel-like material.

6. The pressure measurement device of claim 1 wherein the tube is formed by a polymeric material.

7. The pressure measurement device of claim 1 wherein the tube is a urethane material.

8. The pressure measurement device of claim 1 wherein the gel-like material is a hydrophobic gel.

9. The pressure measurement device of claim 1 wherein the gel-like material is a silicon-based material.

10. The pressure measurement device of claim 1 wherein the gel-like material has a length of between about 1 millimeter and about 3 millimeters.

11. The pressure measurment device of claim 1 wherein the tube has an outside diameter of between about 0.5 millimeter and about 1.5 millimeters.

12. The pressure measurement device of claim 11 wherein the tube has an inside diameter of between about 0.3 millimeter and about 0.7 millimeters.

13. The pressure measurement device of claim 1 wherein the first end of the tube has a contoured tip.

14. The pressure measurement device of claim 1 and further comprising housing means for containing the pressure transducer means.

15. The pressure measurement device of claim 14 and further comprising:

signal processing and telemetry circuitry located in the housing means and electrically connected to the pressure transducer means for providing telemetry signals based upon the signal which varies as a function of pressure.

16. The pressure measurement device of claim 14 and further comprising a strap surrounding the housing means and having a flap to which sutures may be connected.

17. The pressure measurement device of claim 1 wherein the tube has a cavity at its first end in which the gel-like material is positioned and which contains the liquid.

18. The pressure measurement device of claim 17 wherein a portion of the tube containing the cavity has a smaller wall thickness then other portions of the tube.

19. The pressure measurement device of claim 1 and further comprising a mounting plate through which the first end of the tube extends.

20. The pressure measurement device of claim 19 wherein the tube has an elbow proximate the mounting plate.

21. The pressure measurement device of claim 1 and further comprising:

a protective sleeve at least partially filled with gel-like material mounted on the first end of the tube and removable during implantation of the tube into a body of an animal.

22. A pressure measurement device for measuring a physiological pressure, the device comprising

pressure transducer means for providing a signal which varies as a function of pressure;

pressure transmitting catheter means for transmitting the physiological pressure to the pressure transducer means, the pressure transmitting catheter means including a hollow flexible tube having a distal end for placement at a position at which the physiological pressure is to be measured, a proximal end in communication with the pressure transducer means, a lumen extending from the proximal to the distal end, a cavity in the distal end in communication with the lumen, a plug positioned in the cavity, and a liquid which fills the lumen and a portion of the cavity and interfaces with the pressure transducer means for transmitting pressure from the plug to the pressure transducer means.

23. The pressure measurement device of claim 22 wherein the liquid has a lower viscosity than the plug.

24. The pressure measurement device of claim 22 wherein the plug is a gel-like material.

25. The pressure measurement device of claim 22 wherein the plug is movable with respect to the cavity to compensate for movement of the liquid contained in the lumen and the cavity without building up a pressure differential across the plug.

26. The pressure measurement device of claim 22 wherein a portion of the tube containing the cavity has a smaller wall thickness than a portion of the tube containing the lumen.

27. The pressure measurement device of claim 22 and further comprising a mounting plate through which the distal end of the tube extends.

28. The pressure measurement device of claim 27 wherein the tube has an elbow proximate the mounting plate.

29. The pressure measurement device of claim 22 and further comprising;

a protective sleeve at least partially filled with material which forms the plug and removably mounted on the distal end of the tube.

30. A method of measuring a physiological pressure within a body of an animal, the method comprising:

implanting within the body a pressure measurement device which includes a housing containing a pressure transducer and a transmitter implanted within the body, a pressure transmission catheter connected at a proximal end to the pressure transducer and having a distal end positioned to be exposed to the physiological pressure, the catheter having a lumen extending from the proximal end to the distal end, having a plug of a first flowable material in its distal end and a liquid filling the lumen between the plug and the pressure transducer to transmit the physiological pressure from the plug to the pressure transducer; and

monitoring a signal transmitted by the transmitter as a function of pressure sensed by the pressure transducer.

31. The method of claim 30 wherein the first material is a gel-like material.

32. The method of claim 30 wherein the liquid has a lower viscosity than the first material.

33. The method of claim 30 and further comprising:

attaching a mounting plate, which is connected to the catheter near its distal end, to a body member of the animal.

34. The method of claim 30 and further comprising:

providing a strap around the housing; and

connecting a portion of the strap to the animal.

35. The method of claim 30 wherein the portion of the strap is a connecting flap and wherein the connecting is by sutures.

36. The method of claim 30 and further comprising:

soaking the catheter in a saline solution prior to implantng.

37. The method of claim 30 and further comprising:

providing a protective sleeve over the distal end of the catheter; and

removing the protective sleeve before inserting the distal end into a position where it is exposed to the physiological pressure.

38. The method of claim 30 wherein the plug is movable with respect to the distal end to compensate for movement of the liquid without building up a pressure differential across the plug.

39. The method of claim 30 wherein the physiological pressure is blood presssure and the distal end is positioned in a blood vessel.

40. The method of claim 30 wherein the physiological pressure is intrapleural pressure and the distal end is positioned in a thoracic cavity.

41. The method of claim 30 wherein the physiological pressure is intracranial pressure and the distal end is positioned in a subarachnoid space.

42. A pressure measurement device for measuring a physiological pressure, the device comprising:

pressure transducer means for providing a signal which varies as a function of pressure;

pressure transmitting catheter means for transmitting the physiological pressure to the pressure transducer means, the pressure transmitting catheter means including a hollow flexible tube having a first end for placement at a position at which the physiological pressure is to be measured, a second end in communication with the pressure transducer means, a first material positioned in the tube at the first end, and a liquid which fills the tube and interfaces with the pressure transducer means for transmitting pressure from the first material to the pressure transducer means, wherein the first material is capable of flowing as a viscous fluid and exhibiting a resistance to dissolution, decomposition and mechanical removal from the first end of the tube when subjected to fluid and mechanical forces present when measuring the physiological pressure.