Solid state sphincter myometers

• US 5,533,515 A
• Filed: 08/11/1994
• Issued: 07/09/1996
• Est. Priority Date: 08/11/1994
• Status: Expired due to Term

• Current Assignee: Lahey Clinic Medical Center, Foster-Miller Incorporated (Thermo Fisher Scientific Incorporated)
• Original Assignee: Lahey Clinic Medical Center, Foster-Miller Incorporated (Thermo Fisher Scientific Incorporated)
• Inventors: Nappi, Bruce, Coller, John A., Lane, Alan J.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/289,083
• Time in Patent Office: 698 Days
• Field of Search: 128/675, 128/748, 128/774, 128/778, 128/780, 73/379.02, 73/379.03
• US Class Current: 600/593
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence

Abstract

A system for providing real-time measurements of constriction pressure applied by the inner surface of a body lumen, such as a sphincter, includes a probe comprising an elongated core member having a matrix of pressure transducer regions distributed over the surface of the elongated core member. The preferred matrix of pressure transducer regions is addressed by a first inner array of substantially parallel electrically conductive strips substantially conformed circumferentially to at least a portion of the elongated core member, the first array being disposed in overlapping relationship with a second outer array of substantially parallel electrically conductive strips, and substantially conformed axially to at least the same portion of the elongated core member, so as to provide a matrix of intersection regions. Each pressure transducer region is disposed at a corresponding intersection region, and is in electrical contact with both a electrically conductive strip of the first array, and a electrically conductive strip of the second array. In the preferred embodiment the strips of the outer array are mechanically decoupled from one another by axially-directed slits to allow each individual strip to respond independently under hydrostatically applied pressures. A method of making the probe from commercially available materials is also disclosed.

Claims

1. A system for measuring constriction pressure within a body lumen, said system comprising:

an elongated cylindrical core member;

a first array of substantially parallel, electrically-conductive strips substantially conformed to at least a portion of said elongated cylindrical core member;

a second array of substantially parallel, electrically-conductive strips, disposed transverse to and in overlapping relationship with said first array of substantially parallel electrically conductive strips, and substantially conformed to at least said portion of said elongated core member, so as to provide with said first array a plurality of pressure transducer regions around the circumference and along the axis of said core member; and

means, disposed between said first and second arrays at said pressure transducer regions, for defining a predetermined, measurable parameter at each of said regions between the corresponding electrical conductive strips of the first and second arrays such that the parameter varies as a function of a force applied to each of said regions so that constriction pressure within a body lumen can be measured.

2. The system of claim 1, wherein said means for defining a predetermined, measurable parameter at each pressure transducer region includes a layer of pressure-transducer material in electrical contact with the corresponding strips of said first and second arrays.

3. The system of claim 2, wherein said pressure-transducer material is characterized by an electrical resistance that changes in response to applied pressure.

4. The system of claim 1, wherein each electrically conductive strip of said first array is coated with a layer of pressure-transducer material.

5. The system of claim 4, wherein each electrically conductive strip of said second array is coated with a layer of pressure-transducer material.

6. The system of claim 1, further comprising:

a protective layer substantially conformed to at least a portion of said elongated core member, and substantially enclosing said first and second arrays of substantially parallel electrically conductive strips.

7. The system of claim 1, wherein the elongated core member is a flexible catheter.

8. The system of claim 1, wherein the elongated core member is adapted for insertion into an anal orifice.

9. The system of claim 1, wherein each pressure transducer region is a solid state device.

10. The system of claim 1, further including:

a flexible sheet having a first side and a second side,

a portion of said first side supporting said first array of substantially parallel electrically conductive strips, and a portion of said second side supporting said second array of substantially parallel electrically conductive strips.

11. The system of claim 10, wherein a portion of said flexible sheet defines a plurality of slits parallel to and in between said electrically conductive strips, said slits serving to substantially mechanically decouple each electrically conductive strip from other substantially parallel electrically conductive strips.

12. The system of claim 10, wherein each electrically conductive strip of said first array is coated with a layer of pressure-transducer material.

13. The system of claim 12, wherein each electrically conductive strip of said second array is coated with a layer of pressure-transducer material.

14. The system of claim 10, wherein said flexible sheet is in wrapped relationship with said elongated member such that said first array of substantially parallel electrically conductive strips is in overlapping relationship with said second array of substantially parallel electrically conductive strips so as to provide a plurality of intersection regions, and

wherein each pressure transducer region is disposed at an intersection region of said plurality of intersection regions, and is in electrical contact with both a electrically conductive strip of said first array, and a electrically conductive strip of said second array.

15. The system of claim 1, further including:

a first flexible sheet having a first side, a portion of said first side supporting said first array of substantially parallel electrically conductive strips;

a second flexible sheet having a second side in confronting relationship with said the first side of said first flexible sheet, a portion of said second side supporting said second array of substantially parallel electrically conductive strips.

16. The system of claim 15, wherein said first flexible sheet is bonded to said second flexible sheet along at least a substantially straight line segment.

17. The system of claim 16, wherein said first flexible sheet is bonded to said second flexible sheet along a substantially straight line segment extending longitudinally with respect to said elongated core member.

18. The system of claim 15, wherein one of said first flexible sheet and said second flexible sheet defines a plurality of slits parallel to and in between said electrically conductive strips of said one flexible sheet, said slits serving to substantially mechanically decouple each electrically conductive strip from other substantially parallel electrically conductive strips.

19. The system of claim 15, wherein each electrically conductive strip of said first array is coated with a layer of pressure-transducer material.

20. The system of claim 19, wherein each electrically conductive strip of said second array is coated with a layer of pressure-transducer material.

21. The system of claim 15, wherein said first and second flexible sheets are in wrapped relationship with said elongated member such that said first array of substantially parallel electrically conductive strips is in overlapping relationship with said second array of substantially parallel conductive strips so as to provide a plurality of intersection regions, and

wherein each pressure transducer region is disposed at an intersection region of said plurality of intersection regions, and is in electrical contact with both a electrically conductive strip of said first array, and a electrically conductive strip of said second array.

22. The system of claim 1, wherein said plurality of pressure transducer regions are adapted to remain stationary with respect to said body lumen while measuring constriction pressure therein.

23. The system of claim 1, further including:

data acquisition and display means, connected to said array of pressure transducer regions, for real-time data acquisition and display of signals provided by said array of pressure transducer regions.

24. The system of claim 23, wherein said data acquisition and display means includes:

means for multiplexing so as to provide substantially simultaneous readings of said plurality of pressure transducer regions.

25. The system of claim 23, further including:

analysis means, connected to said data acquisition and display means, for providing analysis of complex spatio-temporal pressure patterns.

26. The system of claim 1, further including:

an inflatable balloon attached to an end of said elongated core member.

27. The system of claim 26, further including:

means for inflating said inflatable balloon.

28. The system of claim 27, wherein said means for inflating said inflatable balloon includes a source of forced air in fluid communication with said inflatable balloon.

29. The system of claim 1, wherein said electrically-conductive strips of said first array are oriented substantially circumferentially around said core member, said electrically-conductive strips of the second array are disposed over the electrically-conductive strips of the first array and oriented substantially parallel to the elongated direction of said core member and perpendicular to the electrically-conductive strips of the first array, wherein said electrically-conductive strips of the second array are mechanically decoupled from one another so that said system is capable of measuring hydrostatic pressure.

30. The system of claim 29, wherein each of said first and second arrays are supported by a plastic sheet, said plastic sheet supporting said second array including a plurality of longitudinally directed slits, one slit disposed between each adjacent pair of electrically-conductive strips of the second array so as to mechanically couple the strips of said second array.