BURR HOLE SEALING DEVICE FOR PREVENTING BRAIN SHIFT

• US 20110054518A1
• Filed: 08/27/2009
• Published: 03/03/2011
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., Jaax, Kristen, Carbunaru, Rafael, DiGiore, Andrew
• Granted Patent: US 8,313,453 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

A burr hole sealing device for preventing brain shift during a stimulation lead implantation procedure is provided. The device includes a suction cup ring and a self-sealing membrane positioned within the aperture of the ring. The sealing device is attached adjacent to a burr hole and over a dura layer that is exposed in the bottom of the burr hole. The stimulation lead is disposed through the burr hole, through the membrane, through the dura layer and into brain tissue. The membrane is configured to allow the lead to pass therethrough while maintaining a tight seal around the diameter of the lead, thereby hindering leakage of cerebrospinal fluid out of the cranial cavity and maintaining a substantially fixed intracranial pressure. In one embodiment, the sealing device includes a syringe for adding fluid to, or removing fluid from, the cranial cavity in response to a detected change in intracranial pressure.

Claims

1. A burr hole sealing apparatus, comprising:

a suction cup ring configured for forming a vacuum seal with tissue adjacent to a cranial burr hole, the suction cup ring having an inner diameter, an outer diameter, a central opening, a convex upper surface between the inner and outer diameters, and a concave lower surface between the inner and outer diameters; and

an inner membrane of puncturable, self-sealing material disposed within the central opening.

2. The apparatus of claim 1, wherein the inner membrane is attached directly to the inner diameter of the ring.

3. The apparatus of claim 1, wherein the inner membrane is configured for being punctured by an elongated medical device and for allowing the medical device to pass therethrough while maintaining a tight seal around a diameter of the medical device.

4. The apparatus of claim 1, wherein the ring is configured for being positioned within the cranial burr hole and for being attached directly to a dura layer that is exposed at a bottom of the burr hole.

5. The apparatus of claim 4, wherein the outer diameter of the ring is less than or equal to a diameter of the burr hole.

6. The apparatus of claim 1, further comprising an attachment portion, wherein the inner membrane is configured for being disposed within the central opening by removably attaching to the attachment portion.

7. The apparatus of claim 6, wherein the attachment portion is a threaded collar disposed within the central opening of the ring.

8. The apparatus of claim 1, further comprising a syringe for adding fluid to and removing fluid from a cranial cavity through the cranial burr hole.

9. The apparatus of claim 8, wherein the syringe comprises a central passageway and a fluid chamber surrounding the central passageway, wherein the central passageway is configured for allowing an elongated medical device to pass therethrough.

10. The apparatus of claim 9, wherein the inner membrane is disposed on a distal end of the central passageway, a fluid opening is disposed on a distal end of the fluid chamber, and the fluid opening at least partially surrounds the inner membrane.

11. The apparatus of claim 8, wherein the syringe comprises a manually operated plunger.

12. The apparatus of claim 8, further comprising a pressure transducer for monitoring a pressure within the cranial cavity, wherein the apparatus is configured for automatically maintaining the pressure at a substantially fixed pressure level by maintaining a volume of cerebrospinal fluid within the cranial cavity at a substantially fixed fluid level.

13. The apparatus of claim 12, further comprising a pressure regulator in communication with the pressure transducer, wherein the syringe comprises a plunger and the pressure regulator is configured for automatically operating the plunger.

14. The apparatus of claim 8, wherein the syringe comprises a fluid chamber and a needle configured for puncturing a dura layer and allowing fluid to flow between the fluid chamber and the cranial cavity.

15. The apparatus of claim 14, wherein the needle is configured for puncturing the inner membrane.

16. The apparatus of claim 1, wherein the tissue adjacent to the burr hole is a skull bone that surrounds a top of the burr hole.

17. The apparatus of claim 16, wherein the inner diameter of the ring is greater than a diameter of the burr hole.

18. The apparatus of claim 1, wherein the ring comprises a tab configured for facilitating release of the vacuum seal.

19. A method for performing a medical procedure on a patient, comprising:

attaching a burr hole sealing device adjacent to a cranial burr hole that exposes a dura layer, wherein the burr hole sealing device includes an aperture disposed over the exposed dura layer;

introducing an elongated medical device through the aperture of the sealing device, through the burr hole, through the dura layer, and into the brain tissue of the patient; and

allowing the sealing device to maintain a substantially fixed intracranial pressure while the medical device is disposed through the dura layer.

20. The method of claim 19, wherein maintaining the substantially fixed intracranial pressure comprises maintaining a substantially fixed volume of cerebrospinal fluid within a cranial cavity.

21. The method of claim 19, wherein maintaining the substantially fixed intracranial pressure comprises:

monitoring the intracranial pressure;

adding fluid into a cranial cavity if a decrease in the intracranial pressure is detected; and

removing fluid from the cranial cavity if an increase in the intracranial pressure is detected.

22. The method of claim 19, wherein the burr hole sealing device includes a syringe and maintaining the substantially fixed intracranial pressure comprises at least one of adding fluid and removing fluid through the syringe.

23. The method of claim 22, wherein introducing the elongated medical device comprises passing the elongated medical device through a central channel in the syringe, and wherein adding and removing the fluid is performed through a fluid chamber surrounding the central channel.

24. The method of claim 22, wherein the burr hole sealing device comprises an inner membrane, and the method further comprises puncturing the inner membrane with the syringe.

25. The method of claim 19, wherein the burr hole sealing device comprises an attachment mechanism surrounding an inner membrane, and wherein introducing the elongated medical device through the aperture of the sealing device comprises introducing the elongated medical device through the inner membrane.

26. The method of claim 25, wherein the attachment mechanism comprises a suction cup ring, and attaching the burr hole sealing device adjacent to the burr hole comprises vacuum sealing the suction cup ring to a surface adjacent to the burr hole and attaching the inner membrane to the ring.

27. The method of claim 25, wherein the attachment mechanism comprises a suction cup ring, and attaching the burr hole sealing device adjacent to the burr hole comprises vacuum sealing the suction cup ring to a top surface of a skull bone that surrounds the burr hole.

28. The method of claim 25, wherein the attachment mechanism comprises a suction cup ring, and attaching the burr hole sealing device adjacent to the burr hole comprises vacuum sealing the suction cup ring to the dura layer.

29. The method of claim 19, wherein the step of allowing the sealing device to maintain the substantially fixed intracranial pressure comprises automatically operating the sealing device to actively maintain the substantially fixed intracranial pressure.

30. The method of claim 19, wherein the step of allowing the sealing device to maintain the substantially fixed intracranial pressure comprises allowing the sealing device to passively maintain the substantially fixed intracranial pressure.

31. The method of claim 19, wherein the step of allowing the sealing device to maintain the substantially fixed intracranial pressure comprises manually operating the sealing device to actively maintain the substantially fixed intracranial pressure.

32. A burr hole sealing system, comprising:

a sealing mechanism configured to be attached adjacent a cranial burr hole, to allow an elongated medical device to be disposed through a dura layer and into a cranial cavity, and to hinder leakage of cerebrospinal fluid from the cranial cavity while the elongated medical device is disposed through the dura layer; and

a syringe attached to the sealing mechanism and configured for maintaining a substantially fixed intracranial pressure within the cranial cavity while the elongated medical device is disposed through the dura layer.

33. The system of claim 32, wherein the sealing mechanism is configured for adhering to tissue adjacent to the burr hole.

34. The system of claim 32, wherein the sealing mechanism is configured for forming a seal around a diameter of the elongated medical device while the elongated medical device is disposed through the dura layer.

35. The system of claim 32, wherein the sealing mechanism comprises an inner membrane configured for forming a seal around a diameter of the elongated medical device while the elongated medical device is disposed through the dura layer.

36. The system of claim 35, wherein the sealing mechanism includes a suction cup ring comprising an aperture, and the inner membrane is disposed within the aperture of the suction cup ring.

37. The system of claim 32, wherein the syringe comprises a central passage, a fluid chamber surrounding the central passage, and a membrane on a distal end of the central passage, wherein the central passage and the membrane are configured for allowing the elongated medical device to pass therethrough.

38. The system of claim 32, further comprising a pressure transducer configured for monitoring the intracranial pressure.

39. The system of claim 38, wherein the syringe comprises a plunger, and wherein the system further comprises a pressure regulator in communication with the pressure transducer, wherein the pressure regulator is configured for automatically operating the plunger in response to a change in pressure detected by the pressure transducer.

40. The system of claim 37, wherein the syringe comprises a manually operated plunger.

41. A kit for preventing brain shift, comprising:

an attachment mechanism configured for adhering to tissue adjacent to a cranial burr hole and for allowing an elongated medical device to be disposed through a dura layer and into a cranial cavity; and

a syringe configured for engaging the attachment mechanism and for maintaining a substantially fixed intracranial pressure within the cranial cavity while the elongated medical device is disposed through the dura layer.

42. The kit of claim 41, wherein the attachment mechanism comprises an aperture therethrough, and wherein the kit further comprises a membrane configured for being disposed within the aperture and for forming a seal around the elongated medical device while the elongated medical device is disposed through the dura layer.

43. The kit of claim 42, wherein the attachment mechanism further comprises a suction cup ring and the membrane is attached directly to the suction cup ring.

44. The kit of claim 43, wherein the syringe is configured for puncturing and passing through the membrane.

45. The kit of claim 42, wherein the membrane is attached directly to a distal end of the syringe.

46. The kit of claim 45, wherein the syringe is configured for attaching to the attachment mechanism via cooperating threads on the attachment mechanism and the distal end of the syringe.

47. The kit of claim 41, wherein the attachment mechanism is configured for adhering to the dura layer.

48. The kit of claim 41, wherein the attachment mechanism is configured for adhering to a skull bone that surrounds a top of the burr hole.

49. The kit of claim 41, wherein the syringe comprises a central passageway configured for allowing the elongated medical device to pass therethrough, and a fluid chamber at least partially surrounding the central passageway.

50. The kit of claim 41, further comprising a pressure transducer configured for monitoring the intracranial pressure.

51. The kit of claim 50, further comprising a pressure regulator configured for being coupled to the pressure transducer and for automatically operating the syringe.

52. The kit of claim 49, wherein the syringe comprises a manually operated plunger coupled to the fluid chamber.