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

• US 9,168,005 B2
• Filed: 10/26/2012
• Issued: 10/27/2015
• 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-Leonard, Catherine Hook
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/661,315
• Publication Number:
  US 20130046152A1
• Time in Patent Office: 1,096 Days
• US Class Current: 1/1
• 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 from an outer surface of the external wall and into the internal cavity thereof;

placing a sensing unit in the second incision such that a distal end of the sensing unit is within the external wall or extends into the internal cavity and a proximal end of the sensing unit is outside the organ and exterior of the external wall thereof, the sensing unit consisting essentially of a sensing device and an anchor to which the sensing device is secured, the sensing device having a distal end disposed at the distal end of the sensing unit and a sensing element that is disposed at the distal end of the sensing device and adapted to sense the physiological parameter within the internal cavity, the anchor comprising a distal portion that has arms and a proximal portion that has legs and defines the proximal end of the sensing unit, the distal portion of the sensing device and the distal portion of the anchor and the arms thereof being inserted through the second incision during the placing step, the proximal portion of the anchor and the legs thereof not being inserted into the second incision during the placing step but instead being external to the organ following the placing step;

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, the sensing element is exposed to the internal cavity, the second incision is occluded by only the sensing unit, the arms of the distal portion radially expand outward to engage tips of the arms with an inner surface of the external wall of the organ, and the legs of the proximal portion of the anchor radially expand outward to engage tips of the legs with the outer surface of the external wall of the organ so that the tips of the arms and the tips of the legs clamp the external wall therebetween as a result of the securing step;

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 distal end of the sensing device is recessed within the anchor such that the anchor 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 distal end of the sensing unit does not extend more than one centimeter into the internal cavity following the securing step.

6. The minimally-invasive surgical procedure according to claim 1, wherein the organ is a heart, the internal cavity is a chamber of the heart, and the distal end of the sensing device 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.

7. The minimally-invasive surgical procedure according to claim 1, wherein the distal end of the sensing device has a distal face at which the sensing element is disposed, the physiological parameter is of a biological fluid within the internal cavity, and contact between the biological fluid and the sensing device is only at the distal face of the sensing device.

8. The minimally-invasive surgical procedure according to claim 7, wherein the distal face of the sensing element is flat and defined by a biocompatible semiconductor material.

9. The minimally-invasive surgical procedure according to claim 1, wherein the arms do not protrude more than five millimeters into the internal cavity following the securing step.

10. The minimally-invasive surgical procedure according to claim 1, wherein the legs have a compound deployment action by which the legs initially spread radially and then travel axially in a distal direction until the tips of the legs engage and become embedded in the external wall of the organ.

11. The minimally-invasive surgical procedure according to claim 1, wherein the sensing device has a cylindrical shape with the distal end thereof 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.

12. 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.

13. 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.

14. The minimally-invasive surgical procedure according to claim 13, wherein the telemetry antenna of the sensing unit is within the sensing device.

15. The minimally-invasive surgical procedure according to claim 13, 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.

16. The minimally-invasive surgical procedure according to claim 13, 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.

17. The minimally-invasive surgical procedure according to claim 13, 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.

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

19. 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.

20. 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.