Minimally-invasive procedure for monitoring a physiological parameter within an internal organ

• US 8,322,346 B2
• Filed: 06/25/2008
• Issued: 12/04/2012
• Est. Priority Date: 06/28/2007
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Morgan, Catherine Hook
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US12/145,546
• Publication Number:
  US 20090005656A1
• Time in Patent Office: 1,623 Days
• Field of Search: 600/486, 607/126, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

A minimally-invasive surgical procedure for monitoring a physiological parameter within an internal organ of a living body. The procedure entails making a first incision in the body to enable access to the organ. An endoscopic instrument is then inserted through the first incision and a second incision is made therewith through an external wall of the organ and into the internal cavity thereof. A sensing unit is placed in the second incision such that the second incision is occluded by the unit and a proximal end of the unit is outside the organ. The unit includes 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 first incision is closed, after which a readout device outside the body telemetrically communicates with the sensing device to obtain a reading of the physiological parameter.

Claims

1. A minimally-invasive surgical procedure for placing a sensing device through a wall of an internal organ of a living body to sense a physiological parameter in an internal cavity of the organ, the procedure comprising:

making a first incision in the living body to enable access to the internal organ;

inserting an instrument through the first incision and making a second incision therewith through an external wall of the organ and into the internal cavity thereof;

placing a sensing unit in the second incision such that a distal end of the sensing unit at a first extremity thereof is within the external wall or extends into the internal cavity and a proximal end of the sensing unit at an oppositely-disposed second extremity thereof is outside the organ, the sensing unit consisting essentially of a sensing device having a sensing element adapted to sense the physiological parameter within the internal cavity 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 the 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 are within the external wall or extend into the internal cavity, 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 minimally-invasive 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 minimally-invasive 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.

4. The minimally-invasive surgical procedure according to claim 1, wherein the distal end of the sensing unit is recessed beneath an interior lining of the internal cavity, or is substantially flush with the interior lining, or extends into the internal cavity not more than one centimeter beyond the interior lining.

5. The minimally-invasive surgical procedure according to claim 1, wherein the anchor does not extend into the internal cavity.

6. The minimally-invasive surgical procedure according to claim 1, wherein the distal end of the sensing unit does not extend more than one centimeter into the internal cavity following the securing step.

7. The minimally-invasive surgical procedure according to claim 1, wherein 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 of the chamber, or is substantially flush with the endocardium, or extends into the chamber up to eight millimeters beyond the endocardium.

8. The minimally-invasive surgical procedure according to claim 1, wherein the securing step comprises attaching the proximal portion of the anchor to the external wall of the organ.

9. The minimally-invasive surgical procedure according to claim 8, wherein the proximal portion of the anchor is semi-spherically dome-shaped, defines a wall that circumscribes and is spaced radially outward from the tubular housing 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.

10. The minimally-invasive surgical procedure according to claim 8, wherein the proximal portion of the anchor is disk-shaped and oriented transverse to a longitudinal axis of the distal portion.

11. The minimally-invasive surgical procedure according to claim 8, further comprising the step of placing a felt pad between the proximal 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.

12. The minimally-invasive surgical procedure according to claim 8, wherein the distal and proximal portions do not clamp the external wall therebetween.

13. The minimally-invasive 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.

14. The minimally-invasive 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.

15. The minimally-invasive 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.

16. The minimally-invasive surgical procedure according to claim 15, wherein the telemetry antenna of the sensing unit is within the sensing device.

17. The minimally-invasive surgical procedure according to claim 15, wherein the telemetry antenna of the sensing unit is outside the sensing device and implanted at a location within the living body apart from the sensing device.

18. The minimally-invasive surgical procedure according to claim 15, wherein the telemetric communication between the sensing device and the readout device is established using a resonant or passive scheme in which the sensing device telemetrically receives power from the readout device.

19. The minimally-invasive surgical procedure according to claim 15, wherein the telemetric communication between the sensing device and the readout device is established using an active scheme in which the sensing device receives power from a battery within the sensing unit.

20. The minimally-invasive surgical procedure according to claim 1, wherein the sensing element comprises a micromachined structure.

21. The minimally-invasive surgical procedure according to claim 1, wherein the minimally-invasive 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.

22. The minimally-invasive 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.