SYSTEM AND METHOD FOR IMPLANTING A PHYSIOLOGIC SENSOR ASSEMBLY

• US 20130296661A1
• Filed: 05/04/2012
• Published: 11/07/2013
• Est. Priority Date: 05/04/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Bornzin, Gene A., Poore, John W., Somogyi, Zoltan
• Granted Patent: US 9,241,638 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/283 Invasive

Abstract

An implantable physiologic sensor assembly is configured to be implanted within a patient. The assembly includes a module that houses an internal operative chamber, and a flexible pressure-detecting member connected to the module. The module and the pressure-detecting member are separated before implantation into the patient. At least a first end of the pressure-detecting member is configured to be inserted into an artery of the patient and a second end of the pressure-detecting member is connected to the module. The module is configured to be subcutaneously positioned within the patient.

Claims

1. An implantable physiologic sensor assembly configured to be implanted within a patient, the assembly comprising:

a module that houses an internal operative chamber having a processing unit configured to sense at least one physiological attribute of the patient, wherein the module is configured to be subcutaneously positioned within the patient; and

a flexible pressure-detecting member having a first end portion configured to be inserted into vasculature of the patient, and a second end portion that is connectable to the module, wherein the pressure-detecting member is separated from the module while the first end portion is being inserted into the vasculature of the patient, and wherein the second end portion is connected to the module after the first end portion is inserted into the vasculature of the patient.

2. The assembly of claim 1, wherein the internal operative chamber comprises a flexible diaphragm that abuts the second end portion of the pressure-detecting member when the second end portion is connected to the module.

3. The assembly of claim 2, wherein the internal operative chamber further comprises a transducer operatively connected to the flexible diaphragm, wherein the transducer is configured to detect pressure pulses from pumping blood within the vasculature of the patient that are transmitted into the pressure-detecting member.

4. The assembly of claim 1, wherein the second end portion of the pressure-detecting member comprises a rigid connector connected to a flexible sheath.

5. The assembly of claim 4, wherein the flexible sheath comprises a flexible cannula.

6. The assembly of claim 4, wherein the module comprises a connector port configured to receive and securely retain the connector of the pressure-detecting member.

7. The assembly of claim 6, wherein one of the connector port or the connector comprises a detent, and wherein the other of the connector port or the connector comprises a reciprocal groove configured to securely retain the detent so that the module is secured to the pressure-detecting member.

8. The assembly of claim 6, wherein the connector port comprises:

a needle tip; and

a membrane configured to retain a pressure-transmitting fluid within the connector port prior to the connector port receiving and retaining the connector.

9. The assembly of claim 6, wherein the connector comprises a membrane configured to retain a pressure-transmitting fluid within the pressure-detecting member prior to the connector port receiving and retaining the connector.

10. The assembly of claim 1, further comprising at least one electrode extending from the module, wherein the at least one electrode is configured for use in connection with an electrocardiogram.

11. The assembly of claim 1, wherein the internal operative chamber houses a blood analyzer configured to monitor the glucose level of a blood sample.

12. The assembly of claim 11, wherein the module comprises a blood inlet port and a blood outlet port connected by a channel, wherein the blood analyzer is disposed within the channel.

13. The assembly of claim 1, wherein the processing unit is configured to detect pressure pulses transmitted from the pressure-detecting member.

14. The assembly of claim 1, wherein the internal operative chamber comprises a memory configured to store one or more of blood pressure data, electrocardiogram data, or blood glucose data.

15. The assembly of claim 1, wherein the internal operative chamber comprises at least one telemetry coil configured to communicate with an external device.

16. The assembly of claim 15, wherein the at least one telemetry coil is configured to receive electromagnetic RF power signals to provide power to the assembly.

17. The assembly of claim 1, wherein the internal operative chamber comprises a posture-detecting device configured to detect a posture of the patient.

18. A method of implanting a physiologic sensor assembly into a patient, the method comprising:

introducing a hypodermic needle into vasculature of the patient at an injection site;

moving a distal tip of a pressure-detecting member into a proximal end of the hypodermic needle;

introducing a first end portion of the pressure-detecting member into the vasculature through the hypodermic needle;

removing the hypodermic needle from a second end portion of the pressure-detecting member;

making an incision proximate the injection site;

forming a pocket through the incision;

connecting a module to the second end portion of the pressure-detecting member to form the physiologic sensor assembly; and

inserting the module into the pocket.

19. The method of claim 18, further comprising:

positioning a remaining portion of the pressure-detecting member that is outside of the patient into one or both of the vasculature or the pocket; and

closing the incision after the positioning.

20. The method of claim 18, wherein the connecting comprises inserting a rigid connector of the pressure-detecting member into a connector port of the module.

21. A method of operating a physiologic sensor assembly that is implanted within a patient, the method comprising:

monitoring blood pressure of the patient with the physiologic sensor assembly;

performing an electrocardiogram (EKG) of the patient through electrodes extending from the physiologic sensor assembly;

storing rolling short term frames of blood pressure and EKG data in a memory of the physiologic sensor assembly; and

monitoring a posture of the patient with a posture-detecting device of the physiologic sensor assembly.

22. The method of claim 21, further comprising:

recording blood pressure data and EKG data from a time prior to an abrupt change of posture detected by the posture-detecting device to a time after the abrupt change;

storing data from the recording in a memory within the physiologic sensor assembly; and

transferring the data from the memory to an external device through telemetry.

23. The method of claim 21, further comprising monitoring a blood glucose level of the patient with the physiologic sensor assembly.

24. A method of implanting a physiologic sensor assembly into a patient, the method comprising:

introducing a breakaway needle into vasculature of the patient at an injection site;

moving a distal tip of a pressure-detecting member into a proximal end of the breakaway needle;

introducing the pressure-detecting member into the vasculature through the breakaway needle;

separating longitudinal halves of the breakaway needle from the pressure-detecting member;

removing the longitudinal halves of the breakaway needle from the vasculature;

making an incision proximate the injection site;

forming a pocket through the incision; and

inserting a module connected to the pressure-detecting member into the pocket.

25. The method of claim 24, further comprising connecting the module to the pressure-detecting member.

26. The method of claim 24, further comprising integrally forming the module with the pressure-detecting member prior to the breakaway needle being inserted into the vasculature of the patient

27. The method of claim 24, further comprising:

positioning a remaining portion of the pressure-detecting member that is outside of the patient into one or both of the vasculature or the pocket; and

closing the incision after the positioning.

28. The method of claim 24, further comprising permanently forming the module and the pressure-detecting member as an integral unit.