Sensor unit and procedure for monitoring intracranial physiological properties

• US 8,343,068 B2
• Filed: 05/25/2010
• Issued: 01/01/2013
• Est. Priority Date: 11/29/2007
• Status: Active Grant

• Current Assignee: UIM Pressure Implant Incorporated
• Original Assignee: Integrated Sensing Systems Incorporated
• Inventors: Najafi, Nader, Morgan, Catherine Hook, Goetzinger, David Joseph, Massoud-Ansari, Sonbol
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US12/786,685
• Publication Number:
  US 20100262036A1
• Time in Patent Office: 952 Days
• Field of Search: 600/378, 600/561, 600/302, 600/587
• US Class Current: 600/561
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/031 Intracranial pressure
• 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 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6864 Burr holes

Abstract

An anchor for an implantable sensing device, a sensor unit formed by the anchor and sensing device, and a surgical procedure for implanting the sensor unit for monitoring a physiological parameter within a cavity of a living body, such as an intracranial physiological property. The anchor includes a shank portion and a head portion. The shank portion defines a distal end of the anchor and has a bore defining an opening at the distal end. The head portion defines a proximal end of the anchor and has a larger cross-sectional dimension than the shank portion. The sensor unit comprises the anchor and the sensing device placed and secured within the bore of the anchor so that a sensing element of the sensing device is exposed for sensing the physiological parameter within the cavity.

Claims

1. An sensor unit configured to position a sensing element for monitoring a physiological parameter within a cavity of a living body, the sensor unit comprising:

an anchor comprising;

a shank portion defining a distal end of the anchor, the shank portion having an outer cross-sectional shape that defines a maximum outer cross-sectional dimension thereof, the shank portion having a bore defining an opening at the distal end of the anchor, the opening having a cross-sectional shape; and

a head portion defining a proximal end of the anchor and having an outer cross-sectional shape that defines a larger cross-sectional dimension than the maximum outer cross-sectional dimension of the shank portion;

a sensing device comprising a hermetically-sealed housing that has an outer cross-sectional shape, a proximal end, and an oppositely-disposed distal end at which the sensing element is disposed, the housing containing processing circuitry electrically coupled to the sensing element; and

a telemetry antennae adapted to communicate with the processing circuitry within the housing of the sensing device;

wherein the opening in the shank portion of the anchor has a cross-sectional shape that is complementary to the outer cross-sectional shape of the housing of the sensing device, the housing is assembled with the anchor through the opening in the shank portion so that at least the proximal end of the housing is within the bore of the anchor, the distal end of the housing is exposed by the opening of the bore, the housing closes the opening in the bore to prevent biological matter from entering the bore, and the sensing element is exposed by the opening of the bore to sense the physiological parameter.

2. The sensor unit according to claim 1, wherein the shank portion comprises means for securing the anchor within a hole.

3. The sensor unit according to claim 2, wherein the securing means is at least one biocompatible attachment device chosen from the group consisting of inserts, threads, nails, screws, springs, and adhesives.

4. The sensor unit according to claim 2, wherein the anchor consists of the shank portion, the head portion, the bore, and the securing means.

5. The sensor unit according to claim 1 wherein the sensing device is operable to communicate telemetrically a reading of the physiological parameter to a readout device that is not adapted to be implanted in the living body.

6. The sensor unit according to claim 1, wherein the distal end of the housing of the sensing device protrudes from the bore of the anchor such that the sensing device defines a distal end of the sensor unit.

7. The sensor unit according to claim 1 wherein the proximal end of the housing is concealed within the bore of the anchor.

8. The sensor unit according to claim claim 1, wherein the physiological parameter is pressure.

9. The sensor unit according to claim 8, wherein the sensing element comprises a diaphragm responsive to pressure.

10. The sensor unit according to claim 9, wherein the diaphragm is at a distal surface defined by the distal end of the housing of the sensing device.

11. The sensor unit according to claim claim 1, wherein the sensing element comprises a micromachined structure fabricated by additive and subtractive processes performed on a substrate.

12. The sensor unit according to claim 1, wherein the telemetry antenna is adapted for telemetrically communicating a reading of the physiological parameter sensed by the sensing element and electromagnetically receiving power for the sensing device.

13. The sensor unit according to claim 1, wherein the telemetry antenna is within the sensing device.

14. The sensor unit according to claim 1, wherein the telemetry antenna is a separate antenna subassembly and the unit further comprises means for mechanically and electrically coupling the subassembly to the sensing device.

15. The sensor unit according to claim 14, wherein the antenna subassembly comprises a coil on a substrate.

16. The sensor unit according to claim claim 1, wherein the sensor unit is wirelessly coupled with the telemetry antenna to a readout device that is not adapted to be implanted in the living body.

17. The sensor unit according to claim 16, wherein the sensor unit is wirelessly coupled to the readout device for telemetric communication therewith using a resonant scheme in which the sensing device telemetrically receives power from the readout device.

18. The sensor unit according to claim 16, wherein the sensor unit is wirelessly coupled to the readout device for telemetric communication therewith using a passive scheme in which the sensing device telemetrically receives electromagnetic power from the readout device.

19. The sensor unit according to claim 1, wherein the processing circuitry processes electrical communications between the sensing element and the telemetry antenna.

20. The sensor unit according to claim 19, wherein the processing circuitry causes the telemetry antenna to transmit an amplitude modulation transmission.

21. The sensor unit according to claim claim 1, wherein the sensor unit consists of the sensing device, the anchor, and the telemetry antennae.

22. The sensor unit according to claim 1, further comprising a catheter coupled to the housing of the sensing device so that the sensing element of the sensing device is within the catheter, a membrane at a tip of the catheter distal from the sensing device, and means for hydraulically transmitting the physiological parameter from the membrane to the sensing element of the sensing device.

23. A surgical procedure comprising:

providing an anchor comprising a shank portion that defines a distal end of the anchor and a head portion that defines a proximal end of the anchor, the shank portion having a bore defining an opening at the distal end of the anchor, the opening having a cross-sectional shape;

assembling a sensor unit by placing a sensing device through the opening in the distal end of the shank portion of the anchor and into the bore within the shank portion so that the distal end of the anchor or a distal end of the sensing device defines a distal end of the sensor unit, the sensing device closes the opening in the bore to prevent biological matter from entering the bore, and a sensing element of the sensing device is exposed at the distal end of the sensor unit by the opening of the bore, the sensing element being adapted to sense a physiological parameter;

making an incision in the scalp of a patient to expose a portion of the skull;

making a hole through the skull;

placing the shank portion of the anchor the hole such that the distal end of the sensor unit is flush with or protrudes into the cranial cavity within the skull and the head portion of the anchor contacts the skull;

securing the anchor to the skull such that the sensing device is secured to the skull by the anchor and the hole is occluded by the anchor; and

then

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

24. The surgical procedure according to claim 23, wherein, the sensing element is disposed at the distal end of the sensing device, and the distal end of the sensing device protrudes from the distal end of the anchor such that the sensing device defines the distal end of the sensor unit.

25. The surgical procedure according to claim 23, wherein the shank portion occludes the hole as a result of the placing step, and the head portion is not inserted into the hole during the placing step but instead is external to the skull following the placing step.

26. The surgical procedure according to claim 25, wherein the securing step comprises securing the shank portion of the anchor to the skull.

27. The surgical procedure according to claim 26, wherein the shank portion of the anchor is secured within the hole in the skull by an interference fit therebetween.

28. The surgical procedure according to claim 26, wherein the shank portion of the anchor is secured within the hole in the skull by an element chosen from the group consisting of inserts, threads, nails, screws, springs, and adhesives.

29. The surgical procedure according to claim 25, wherein an interference fit does not exist between the shank portion of the anchor and the hole in the skull.

30. The surgical procedure according to claim 25, wherein the securing step comprises securing the head portion of the anchor to the skull.

31. The surgical procedure according to claim 30, wherein the head portion of the anchor is secured to the skull by an element chosen from the group consisting of nails, screws, springs, and adhesives.

32. The surgical procedure according to claim 25, wherein the bore of the anchor is entirely located within the shank portion of the anchor.

33. The surgical procedure according to claim 25, wherein the sensor unit is placed in the hole such that the distal end of the sensor unit presses against the dura mater without penetrating the dura mater (extradural), or penetrates the dura mater, or is placed beneath the dura mater (subdural) in the subarachnoid space, or is placed beneath the pia mater and extends extend into brain tissue.

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

35. The surgical procedure according to claim 23, wherein the telemetric communicating step 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.

36. The surgical procedure according to claim 23, wherein the telemetric communicating step 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.

37. The surgical procedure according to claim 23, wherein the sensing device comprises a hermetically-sealed housing that has an outer cross-sectional shape and defines the distal end of the sensing device and an oppositely-disposed proximal end of the sensing device, the procedure further comprising processing electrical communications between the sensing element and a telemetry antenna located within the housing of the sensing device.

38. The surgical procedure according to claim 37, wherein the telemetry antenna is within the housing of the sensing device and is placed with the sensor unit within the hole in the skull.

39. The surgical procedure according to claim 37, wherein the telemetry antenna is a separate antenna subassembly that is not placed with the sensor unit within the hole in the skill.

40. The surgical procedure according to claim 39, wherein the antenna subassembly comprises a coil on a substrate placed outside the skull.

41. The surgical procedure according to claim 37, wherein the telemetry antenna of the sensor unit transmits an amplitude modulation transmission to the readout device.

42. The surgical procedure according to claim 23, wherein the surgical procedure is part of at least one of the following medical procedures:

diagnosis, treatment intervention, tailoring of medications, disease management, identification of complications, and chronic disease management.

43. The surgical procedure according to claim 23, wherein the readout device is used to perform at least one of the following:

remote monitoring of the patient, closed-loop drug delivery of medications to treat the patient, warning of changes in the physiological parameter, 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.

44. The surgical procedure according to claim 23, wherein the sensor unit consists of the sensing device, the anchor, and means for telemetrically communicating the reading of the physiological parameter to the readout device.

45. The surgical procedure according to claim 23, further comprising coupling a catheter to the sensing device so that a membrane at a tip of the catheter is distal from the sensing device, and hydraulically transmitting the physiological parameter from the membrane through the catheter to the sensing element of the sensing device.

46. The surgical procedure according to claim 23, wherein the surgical procedure is performed on the patient in a civilian, military, or mobile army surgical hospital or on a battlefield, or during transportation of the patient therebetween.