DELIVERY METHOD AND SYSTEM FOR MONITORING CARDIOVASCULAR PRESSURES

• US 20060047205A1
• Filed: 11/01/2005
• Published: 03/02/2006
• Est. Priority Date: 10/07/2002
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Goetzinger, David, Ludomirsky, Achiau, Morgan, Catherine
• Granted Patent: US 8,512,252 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A delivery method and system for noninvasively monitoring cardiac physiologic parameters used to evaluate patients with cardiovascular conditions. The system includes an implantable sensing device configured for chronic implantation in a cavity of the cardiovascular system, such as the heart, pulmonary artery (PA), etc. The method involves introducing the sensing device through a cardiovascular cavity that is upstream in the vasculature from the cavity where implantation is intended and has a larger diameter than the intended cavity, and thereafter blood flow through the cardiovascular system delivers the device to the intended cavity. The device is sized and configured so as to secure itself within the intended cavity when the device moves through the cavity to a point where the diameter narrows sufficiently to secure the device and so as to be oriented once secured to sense a pressure either within, upstream (wedge), or downstream (distal) of the cavity.

Claims

1. A method of delivering an implantable sensing device to a first cardiovascular cavity of a human patient for sensing at least one pressure within the cardiovascular system of the patient for assessing a cardiovascular condition of the patient, the method comprising the steps of placing the sensing device in a second cardiovascular cavity having a larger diameter than the first cardiovascular cavity,

and thereafter allowing blood flow through the cardiovascular system to deliver the sensing device to the first cardiovascular cavity, wherein the sensing device is sized and configured so as to secure itself within the first cardiovascular cavity as the sensing device moves therethrough, and so as to be oriented once secured to sense a pressure within the first cardiovascular cavity.

2. The method according to claim 1, wherein the sensing device secures itself to the first cardiovascular cavity as a result of the first cardiovascular cavity having a diameter smaller than the sensing device.

3. The method according to claim 1, wherein the first cardiovascular cavity is a first pulmonary artery and the second cardiovascular cavity is a second pulmonary artery.

4. The method according to claim 3, wherein the sensing device occludes the first pulmonary artery and is oriented within the first pulmonary artery for measuring pulmonary capillary wedge pressure.

5. The method according to claim 1, further comprising the step of placing the sensing device using a catheter delivery technique.

6. The method according to claim 5 wherein the catheter delivery technique comprises temporarily securing the sensing device at a distal tip of a catheter with an interference fit therebetween.

7. The method according to claim 6, wherein the catheter delivery technique comprises releasing the sensing device from the distal tip of the catheter with hydraulic pressure delivered by the catheter to the sensing device.

8. The method according to claim 5, wherein the catheter delivery technique comprises temporarily securing and subsequently releasing the sensing device at a distal tip of a catheter with a tether.

9. The method according to claim 5, wherein the catheter delivery technique comprises temporarily securing and subsequently releasing the sensing device at a distal tip of a catheter with resilient fingers of a collet within the catheter.

10. The method according to claim 9, wherein the resilient fingers of the collet are expanded to release the sensing device.

11. The method according to claim 9, wherein the resilient fingers of the collet are collapsed to release the sensing device.

12. The method according to claim 1, further comprising the steps of cell growth and encapsulation of the sensing device to stabilize the sensing device in the first cardiovascular cavity.

13. The method according to claim 1, wherein the method is performed for diagnosis or monitoring of the cardiovascular condition of the patient.

14. The method according to claim 13, wherein the cardiovascular condition is pulmonary hypertension.

15. The method according to claim 13, wherein the cardiovascular condition is congenital heart disease.

16. The method according to claim 13, wherein the cardiovascular condition is chronic heart failure.

17. The method according to claim 1, wherein the method is part of at least one procedure chosen from the group consisting of early diagnosis of the cardiovascular condition, early intervention in treatment of the cardiovascular condition, remote monitoring of the patient, tailoring of medications, disease management, identification of complications from the cardiovascular condition, treatment of complications from the cardiovascular condition, feedback regarding the impact of medication on the heart, tuning of pacemaker parameters, feedback regarding the impact of pacing changes on heart function, reduction in frequency and severity of hospitalizations due to the cardiovascular condition, identification of mitral valve stenosis, and treatment of mitral valve stenosis.

25. The system according to claim 18, wherein the sensing device is implanted in the first cardiovascular cavity so as to monitor at least one pressure chosen from the group consisting of the pulmonary artery, right ventricle, left ventricle, left atrium, right atrium, and pulmonary capillary wedge pressures.

26. The system according to claim 25, wherein the sensing device is implanted within a side branch of the pulmonary artery.

31. The system according to claim 18, wherein the sensing device further comprises at least one device chosen from the group consisting of thermal generators, voltage sources, current sources, probes, electrodes, drug delivery pumps, valves, meters, microtools for localized surgical procedures, radiation emitting sources, defibrillators, muscle stimulators, and pacing stimulators.

18. A system for delivering an implantable sensing device to a first cardiovascular cavity of a human patient for sensing at least one pressure within the cardiovascular system of the patient for assessing a cardiovascular condition of the patient, the system comprising:

an implantable sensing device adapted for implantation in the first cardiovascular cavity; and

means for placing the sensing device in a second cardiovascular cavity having a larger diameter than the first cardiovascular cavity, and thereafter allowing blood flow through the cardiovascular system to deliver the sensing device to the first cardiovascular cavity;

wherein the sensing device is sized and configured for securing itself within the first cardiovascular cavity as the sensing device moves therethrough, and for orienting itself when secured to sense a pressure within the first cardiovascular cavity.

19. The system according to claim 18, wherein the placing means comprises a catheter configured for placement in the cardiovascular system, the catheter having means at a distal tip thereof for securing the sensing device while the catheter is advanced through the cardiovascular system and means for releasing the sensing device within the second cardiovascular cavity so as to be carried within the cardiovascular system to the first cardiovascular cavity by blood flowing therethrough, the securing and releasing means being configured to release the sensing device so that the sensing device is oriented to secure itself within the first cardiovascular cavity and sense a pressure within the first cardiovascular cavity.

20. The system according to claim 18, wherein the sensing device comprising at least one inductor coil and at least one pressure sensor.

21. The system according to claim 20, further comprising a reader device that is not implanted in the first cardiovascular cavity, the reader device comprising at least one inductor coil having telemetric means for at least one of electromagnetic telecommunication and electromagnetic wireless powering of the sensing device through the at least one inductor coil of the sensing device.

22. The system according to claim 21, wherein the sensing device comprises at least one of resonant, passive, and active means for telecommunicating and/or telepowering with the reader device.

23. The system according to claim 18, wherein the sensing device further comprises a battery.

24. The system according to claim 23, further comprising wireless means for recharging the battery.

27. The system according to claim 18, wherein the sensing device further comprises means for sensing at least one physiologic parameter chosen from the group consisting of temperature, flow, blood composition, blood gas content, chemical composition, chemical concentration, acceleration, impedance, and vibration.

28. The system according to claim 18, wherein the reader device comprises means for at least one of:

remote monitoring of patients with a cardiovascular condition, monitoring of patients with a cardiovascular condition with telephone-based data and information delivery, monitoring of patients with a cardiovascular condition with wireless telephone-based data and information delivery, monitoring of patients with pulmonary hypertension with web-based data and information delivery, closed-loop drug delivery to treat patients with a cardiovascular condition, closed-loop tuning of medical systems to treat a cardiovascular condition, warning of worsening of a cardiovascular condition, portable or ambulatory monitoring or diagnosing, battery-operation capability, data storage, reporting global positioning coordinates for emergency applications, and communication with other medical devices.

29. The system according to claim 18, wherein the sensing device has an exterior with a shape capable of occluding the first cardiovascular cavity and orienting the sensing device to sense a pressure within the first cardiovascular cavity.

30. The system according to claim 18, wherein the sensing device has an exterior with a shape capable of occluding a branch of the pulmonary artery and orienting the sensing device to sense a pulmonary capillary wedge pressure within the branch of the pulmonary artery.

32. The system according to claim 18, wherein the system is part of a closed-loop medical treatment system.

33. The system according to claim 18, wherein at least a portion of the sensing device is coated with one or more layers of coating materials chosen from the group consisting of silicone, hydrogels, parylene, polymer, nitrides, oxides, nitric oxide generating materials, carbides, silicides, titanium, and combinations thereof.