Procedure and system for monitoring a physiological parameter within an internal organ of a living body

• US 8,267,863 B2
• Filed: 04/29/2008
• Issued: 09/18/2012
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Massoud-Ansari, Sonbol, Morgan, Catherine Hook
• Primary Examiner(s): Lin, Jerry
• Application Number:
  US12/111,954
• Publication Number:
  US 20080269573A1
• Time in Patent Office: 1,603 Days
• Field of Search: 600/302
• US Class Current: 600/302
• 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 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/6883 Sutures
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

A system and surgical procedure for monitoring physiological parameters within an internal organ of a living body. The procedure entails making a first incision to expose the organ and a second incision through an external wall of the organ and into an internal cavity. A sensing unit is placed in the second incision such that a proximal end thereof remains outside the organ. The unit includes a sensing device having a sensing element for sensing the physiological parameter within the organ, and an anchor to which the sensing device is secured. The unit occludes the second incision and a distal end of the unit does not extend more than one centimeter into the cavity. The anchor is then secured to the wall of the organ, after which the first incision is closed and a readout device telemetrically communicates with the sensing device to obtain a reading of the physiological parameter.

Claims

1. A surgical procedure comprising:

making a first incision in a living body to expose at least a portion of an internal organ of the living body, the organ having an internal cavity within which an internal physiological parameter is desired to be sensed;

making a second incision through an external wall of the organ and into the internal cavity;

placing a sensing unit in the second incision such that a proximal end of the sensing unit at a first extremity thereof is outside the organ and a distal end of the sensing unit at an oppositely-disposed second extremity thereof is within the internal cavity of the organ, the sensing unit consisting essentially of a sensing device having a sensing element adapted to sense the physiological parameter within the organ and an anchor to which the sensing device is secured, the anchor comprising first and second portions, the first portion of the anchor comprising a tubular housing in which the sensing device is housed and an open end adjacent the distal end of the sensing unit through which the sensing device is received into the tubular housing and through which the sensing element is exposed, either the first portion of the anchor or the sensing device defining the distal end of the sensing unit, the second portion of the anchor projecting radially from and surrounding the first portion, defining the proximal end of the sensing unit, and comprising means for securing the anchor to an external wall of the organ by engaging a proximal surface of the external wall disposed nearer the proximal end of the sensing unit and not engaging a distal surface of the external wall disposed nearer the distal end of the sensing unit, the sensing unit being placed in the second incision so that the second portion of the anchor, the securing means thereof, and the proximal end of the sensing unit defined thereby are outside the organ, and so that only the first portion of the anchor and the distal end of the sensing unit extend entirely through the external wall, the distal end of the sensing unit does not extend more than one centimeter into the internal cavity of the organ, and the first portion of the anchor occludes the incision; and

securing the anchor to the external wall of the organ such that the sensing device is secured within the second incision by only the anchor and the second incision is occluded by only the first portion of the anchor;

closing the first incision; and

then

telemetrically communicating with the sensing device to obtain a reading of the physiological parameter using a readout device located outside the living body.

2. The surgical procedure according to claim 1, wherein the organ is chosen from the group consisting of a heart, blood vessel, meninges, kidney, lung, bladder, and abdominal wall.

3. The surgical procedure according to claim 1, wherein the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device is recessed within the tubular housing of the first portion of the anchor such that the first portion of the anchor defines the distal end of the sensing unit.

4. The surgical procedure according to claim 1, wherein the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device protrudes from the tubular housing of the first portion of the anchor such that the sensing device defines the distal end of the sensing unit.

5. The surgical procedure according to claim 1, wherein each of the anchor and the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device is flush with the distal end of the anchor.

6. The surgical procedure according to claim 1, wherein the distal end of the sensing unit is recessed up to about two millimeters beneath an interior lining of the internal cavity, or is substantially flush with the interior lining, or extends into the internal cavity up to about eight millimeters beyond the interior lining.

7. The surgical procedure according to claim 1, wherein the anchor does not extend into the internal cavity.

8. The surgical procedure according to claim 1, wherein the surgical procedure is an open chest surgical procedure, the organ is a heart, the internal cavity is a chamber of the heart, the sensing device has a distal end at which the sensing element is disposed, and the distal end of the sensing unit is recessed up to about two millimeters beneath the endocardium lining the chamber, or is substantially flush with the endocardium, or extends into the chamber up to eight millimeters beyond the endocardium.

9. The surgical procedure according to claim 8, wherein the open chest surgical procedure is chosen from the group consisting of bypass surgery, heart valve surgery, and heart transplant surgery.

10. The surgical procedure according to claim 1, wherein the securing step comprises securing the second portion of the anchor to the external wall of the organ.

11. The surgical procedure according to claim 1, wherein the second portion of the anchor is semi-spherically dome-shaped, defines a wall that circumscribes and is spaced radially outward from the first portion of the anchor so as to define an annular gap therebetween, and an edge of the wall faces the external wall of the organ so as not to be exposed to other organs of the living body adjacent the organ.

12. The surgical procedure according to claim 1, wherein the second portion of the anchor is disk-shaped and oriented transverse to a longitudinal axis of the first portion.

13. The surgical procedure according to claim 1, further comprising the step of placing a felt pad between the second portion of the anchor and the external wall of the organ, and the securing step comprises simultaneously securing the felt pad and the anchor to the external wall of the organ.

14. The surgical procedure according to claim 1, wherein the first and second portions do not clamp the external wall therebetween.

15. The surgical procedure according to claim 1, further comprising the step of placing the sensing device in the first portion of the anchor prior to the placing step, and wherein the sensing unit consists of the sensing device and the anchor.

16. The surgical procedure according to claim 15, further comprising the step of securing the sensing device in the first portion of the anchor.

17. The surgical procedure according to claim 1, wherein the second portion of the anchor is secured to the external wall of the organ with biocompatible attachment means.

18. The surgical procedure according to claim 1, wherein the second portion of the anchor is secured to the external wall of the organ with sutures and a felt pad is secured with the sutures between the second portion of the anchor and the external wall of the organ.

19. The surgical procedure according to claim 1, wherein the second portion of the anchor has openings therein and the securing step comprises passing sutures through the openings and into the external wall of the organ.

20. The surgical procedure according to claim 19, wherein the second portion of the anchor comprises a cylindrical wall that circumscribes and is spaced radially outward from the first portion of the anchor so as to define an annular gap therebetween, and the openings are disposed in a distal edge defined by the cylindrical wall.

21. The surgical procedure according to claim 1, wherein the sensing device has a cylindrical shape with a distal end and an oppositely-disposed proximal end disposed within the anchor following the placing step, and the sensing element is at a distal surface defined by the distal end of the sensing device.

22. The surgical procedure according to claim 1, wherein the physiological parameter is at least one chosen from the group consisting of pressure, temperature, flow, acceleration, vibration, composition of a biological fluid, oxygen content of a biological fluid, carbon dioxide content of a biological fluid, glucose content of a biological fluid, gene content of a biological fluid, hormone content of a biological fluid, and gas content of a biological fluid.

23. The surgical procedure according to claim 1, wherein the physiological parameter is pressure.

24. The surgical procedure according to claim 23, wherein the sensing element comprises a diaphragm responsive to pressure within the internal cavity.

25. The surgical procedure according to claim 24, wherein the sensing device has a distal end and an oppositely-disposed proximal end disposed within the tubular housing of the first portion the anchor following the placing step, and the diaphragm is at a distal surface defined by the distal end of the sensing device.

26. The surgical procedure according to claim 1, wherein the sensing unit further comprises a telemetry antenna and the readout device comprises means for telemetrically communicating with the telemetry antenna of the sensing device and optionally means for electromagnetic powering of the sensing device.

27. The surgical procedure according to claim 26, wherein the telemetric communication between the sensing device and the readout device is established using a resonant scheme in which the sensing device telemetrically receives power from the readout device.

28. The surgical procedure according to claim 26, wherein the telemetric communication between the sensing device and the readout device is established using a passive scheme in which the sensing device telemetrically receives electromagnetic power from the readout device or a second separate device.

29. The surgical procedure according to claim 26, wherein the sensing unit further comprises processing circuitry for processing electrical communications between the sensing element and the telemetry antenna of the sensing unit.

30. The surgical procedure according to claim 29, wherein the processing circuitry causes the telemetry antenna of the sensing unit to transmit an amplitude modulation transmission to the telemetric communicating means of the readout device.

31. The surgical procedure according to claim 26, wherein the sensing device obtains power from a power storage device within the sensing unit.

32. The surgical procedure according to claim 1, wherein the sensing element comprises a micromachined structure.

33. The surgical procedure according to claim 1, wherein the surgical procedure is part of at least one of the following medical procedures:

diagnosis of chronic diseases;

diagnosis of a heart failing due to congestive heart failure related conditions;

diagnosis of failure of the organ;

intervention in treatment of congestive heart failure related conditions;

tailoring of medications;

disease management;

identification of complications from congestive heart failure related conditions;

identification of complications from cardiovascular disease related conditions;

treatment of complications from congestive heart failure related conditions;

treatment of complications from cardiovascular disease related conditions;

pacing adjustments to the heart;

reduction in frequency and severity of hospitalizations due to cardiovascular diseases;

reduction in frequency and severity of hospitalizations due to congestive heart failure;

tuning of defibrillator or pacemaker parameters to improve congestive heart failure related conditions;

identification of mitral valve stenosis;

treatment of mitral valve stenosis, feedback regarding the impact of medication on the organ; and

chronic disease management of the organ.

34. The surgical procedure according to claim 1, wherein the readout device is used to perform at least one of the following:

remote monitoring of the organ and the living body, remote monitoring of the organ and the living body with a telephone-based data and information delivery system;

remote monitoring of the organ and the living body with a wireless telephone-based data and information delivery system;

remote monitoring of the organ and the living body with an Internet-based data and information delivery system;

closed-loop drug delivery of medications to treat the organ;

closed-loop pacemaker parameter tuning to treat congestive heart failure or congestive heart failure related conditions;

warning of critical worsening of congestive heart failure or congestive heart failure related conditions;

portable or ambulatory monitoring or diagnosis;

monitoring of battery operation;

data storage;

reporting global positioning coordinates for emergency applications; and

communication with other medical devices chosen from the group consisting of pacemakers, left ventricular assist devices, defibrillators, cardioverter defibrillators, drug delivery systems, non-drug delivery systems, and wireless medical management systems.

35. A system for monitoring a physiological parameter within an internal cavity of an internal organ of a living body, the system comprising:

at least one sensing unit adapted to be implanted in the living body and attached to the organ therein, the sensing unit having a proximal end at a first extremity thereof and a distal end at an oppositely-disposed second extremity thereof, the sensing unit consisting essentially of a sensing device having a sensing element adapted to sense the physiological parameter within the organ and an anchor to which the sensing device is secured, the anchor comprising first and second portions, the first portion of the anchor comprising a tubular housing in which the sensing device is housed and an open end adjacent the distal end of the sensing unit through which the sensing device is received into the tubular housing and through which the sensing element is exposed, either the first portion of the anchor or the sensing device defining the distal end of the sensing unit, the second portion of the anchor projecting radially from and surrounding the first portion, defining the proximal end of the sensing unit, and comprising means for securing the anchor to an external wall of the organ by engaging a proximal surface of the external wall disposed nearer the proximal end of the sensing unit and not engaging a distal surface of the external wall disposed nearer the distal end of the sensing unit, the sensing unit being sized and configured for placement in an incision in the external wall of the organ so that the second portion of the anchor, the securing means thereof, and the proximal end of the sensing unit defined thereby are outside the organ, and so that only the first portion of the anchor and the distal end of the sensing unit extend entirely through the external wall, the distal end of the sensing unit does not extend more than one centimeter into the internal cavity of the organ, and the first portion of the anchor occludes the incision; and

a readout device that is not adapted to be implanted in the living body, the readout device comprising means for telemetrically communicating with the sensing device to obtain a reading of the physiological parameter.

36. The system according to claim 35, wherein the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device is recessed within the tubular housing of the first portion of the anchor such that the anchor defines the distal end of the sensing unit.

37. The system according to claim 35, wherein the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device protrudes from the tubular housing of the first portion of the anchor such that the sensing device defines the distal end of the sensing unit.

38. The system according to claim 35, wherein each of the anchor and the sensing device has a distal end, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device is flush with the distal end of the anchor.

39. The system according to claim 35, wherein the second portion of the anchor is semi-spherically dome-shaped and defines a wall that circumscribes and is spaced radially outward from the first portion of the anchor so as to define an annular gap therebetween.

40. The system according to claim 35, wherein the second portion of the anchor is disk-shaped and oriented transverse to a longitudinal axis of the first portion.

41. The system according to claim 35, wherein the first and second portions are not configured to clamp the external wall therebetween.

42. The system according to claim 35, further comprising means for securing the second portion of the anchor to the external wall of the organ, the securing means being at least one biocompatible attachment device chosen from the group consisting of sutures, nails, screws, springs, and adhesives.

43. The system according to claim 35, wherein the sensing unit consists of the sensing device and the anchor.

44. The system according to claim 35, further comprising a felt pad and sutures for attaching the anchor to the external wall of the organ and securing the felt pad between the external wall and a portion of the anchor.

45. The system according to claim 44, wherein the anchor has openings therein adapted for passing sutures therethrough.

46. The system according to claim 45, wherein the anchor comprises a first portion adapted to be inserted into and occlude the incision and a second portion that surrounds the first portion and is not adapted to be inserted into the incision, and the openings of the anchor are disposed at an outer periphery of the second portion.

47. The system according to claim 35, wherein the sensing device has a cylindrical shape with a distal end and an oppositely-disposed proximal end disposed within the anchor, and the sensing element is at a distal surface defined by the distal end of the sensing device.

48. The system according to claim 35, wherein the physiological parameter is at least one chosen from the group consisting of pressure, temperature, flow, acceleration, vibration, composition of a biological fluid, oxygen content of a biological fluid, carbon dioxide content of a biological fluid, glucose content of a biological fluid, gene content of a biological fluid, hormone content of a biological fluid, and gas content of a biological fluid.

49. The system according to claim 35, wherein the physiological parameter is pressure.

50. The system according to claim 49, wherein the sensing element comprises a diaphragm responsive to pressure.

51. The system according to claim 50, wherein the diaphragm is at a distal surface of the sensing device.

52. The system according to claim 35, wherein the sensing unit further comprises a telemetry antenna, and the telemetric communicating means of the readout device is adapted to telemetrically communicate with the telemetry antenna of the sensing device and optionally electromagnetically power the sensing device.

53. The system according to claim 52, wherein the telemetric communication between the sensing device and the readout device is established using a resonant scheme in which the sensing device telemetrically receives power from the readout device.

54. The system according to claim 52, wherein the telemetric communication between the sensing device and the readout device is established using a passive scheme in which the sensing device telemetrically receives electromagnetic power from the readout device or a second separate device.

55. The system according to claim 52, wherein the sensing unit further comprises processing circuitry for processing electrical communications between the sensing element and the telemetry antenna of the sensing unit.

56. The system according to claim 55, wherein the processing circuitry causes the telemetry antenna of the sensing unit to transmit an amplitude modulation transmission to the telemetric communicating means of the readout device.

57. The system according to claim 52, wherein the sensing device contains a power storage device.

58. The system according to claim 35, wherein the sensing element comprises a micromachined structure.