Intracranial bolt and method of placing and using an intracranial bolt to position a medical device

• US 6,152,933 A
• Filed: 11/10/1998
• Issued: 11/28/2000
• Est. Priority Date: 11/12/1997
• Status: Expired due to Fees

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Penny, William, Lawson, Michael A., Blume, Walter M., Werp, Peter R.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/189,645
• Time in Patent Office: 749 Days
• Field of Search: 606/1, 606/130, 606/184, 606/185, 604/164, 604/167, 604/169, 604/256, 604/165
• US Class Current: 606/130
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An intracranial bolt, for installation in an opening in the skull to provide access to the brain for a medical device, has a bore therethrough for the passage of the medical device, and an inflatable member in the bore which when inflated engages a medical device in the bore, releasably anchoring the device. The inflatable member comprises a cylinder of flexible sheet material inside the bore and secured to the wall of the bore defining an annular pocket therebetween. A passage extends through the bolt to the pocket for the introduction of fluid into the pocket to expanding radially inwardly. The bolt in a medical procedure on the brain by forming an opening in the skull; installing the intracranial bolt in the opening in the skull; and securing the cap on the bolt. When it is time to conduct the procedure, the cap is removed and a medical device can be inserted into the brain through the bolt. The inflatable member can be inflated to temporarily hold the medical device in place.

Claims

1. A clamp for releasably anchoring a medical device extending through an opening in a skull, the clamp comprising:

a body adapted to be secured in the opening in the skull, the body having a bore therethrough for the passage of a medical device, and an inflatable member, positioned in the bore, which when inflated can engage a medical device passing through bore, to releasably anchor the medical device.

2. The clamp of claim 1 wherein the body is shaped to abut substantially a entire circumference of the opening, and the bore extends through the body and is itself surrounded by the body.

3. The clamp according to claim 1 wherein the inflatable member comprises a panel of flexible sheet material secured to the wall of the bore, and wherein there is a passage through the body, opening in the wall of the bore underneath the panel for introducing a fluid under the panel to cause the panel to extend into the bore.

4. The clamp according to claim 3 wherein the panel is generally cylindrical.

5. The clamp according to claim 1 wherein the inflatable member engages the medical device between opposing portions of the inflatable member.

6. The clamp according to claim 1 wherein the inflatable member engages the medical device against a wall of the bore.

7. A clamp for releasably anchoring a medical device extending through an opening in a skull, the clamp comprising:

a body adapted to be secured in the opening in the skull, the body having a bore therethrough for the passage of a medical device;

a panel of flexible sheet material secured to a wall of the bore to form a pocket between the panel and the wall, and a passage through the body communicating with the pocket;

the panel expanding radially inwardly into the bore upon the introduction of fluid into the pocket to engage a medical device passing through the bore to releasably anchor the medical device.

8. The clamp of claim 7 wherein the body is shaped to abut substantially the entire circumference of the opening, and the bore extends through the body and is itself surrounded by the body.

9. The clamp according to claim 8 wherein the panel is generally cylindrical, having first and second ends, and wherein the panel is secured to the wall of the bore adjacent its first and second ends.

10. A clamp for installation in a bore in a skull to releasably anchor a medical device extending into a brain, the clamp having a bore therethrough for the passage of a medical device, and an inflatable member in the bore which when inflated can engage a medical device passing through the bore in the clamp, to releasably anchor the medical device.

11. The clamp of claim 10 wherein the clamp is shaped to abut substantially the entire circumference of the skull bore, and the clamp bore extends through the clamp and is itself surrounded by the clamp.

17. The intracranial bolt according to claim 10 wherein the inflatable member is formed by a wall of the bore and a panel of flexible material extending around the circumference of the bore.

12. An intracranial bolt for installation in an opening in a skull to provide access to a brain for a medical device, the bolt having a bore therethrough for the passage of a medical device, and an inflatable member, in the bore, which when inflated can engage a medical device passing through the bore, to releasably anchor the medical device.

13. The intracranial bolt of claim 12 wherein the bolt is shaped to abut substantially the entire circumference of the opening, and the bore extends through the bolt and is itself surrounded by the bolt.

14. The intracranial bolt according to claim 12 wherein the inflatable member extends around the circumference of the bore, and upon inflation expands radially inwardly into the bore.

15. The intracranial bolt according to claim 14 wherein the inflatable member comprises a cylinder of flexible sheet material inside the bore, the cylinder having first and second ends, and being secured to the wall of the bore at the first and second ends, the cylinder and wall of the bore defining an annular pocket therebetween, the cylinder expanding radially inwardly into the bore upon the introduction of fluid into the pocket.

16. The intracranial bolt according to claim 12 wherein the inflatable member comprises an annular balloon in the bore through which the medical device extends.

18. An intracranial bolt for installation in an opening in a skull to provide access to a brain for a medical device, the bolt having a distal portion adapted to be secured in the opening of the skull, and a proximal portion adapted to project from the skull when the bolt is installed in the opening, and a bore extending between the proximal and distal sections, the proximal portion adapted to sealingly receive a cap for closing the proximal end of the bore.

19. The intracranial bolt of claim 18 wherein the bolt is shaped to abut substantially the entire circumference of the opening, and the bore extends through the bolt and is itself surrounded by the bolt.

20. The intracranial bolt according to claim 18 further comprising an inflatable member, in the bore, which when inflated, expands in the bore to engage a medical device passing through the bore.

21. The intracranial bolt according to claim 20 wherein the inflatable member comprises a panel of flexible material secured over a wall of the bore to form a pocket therebetween, and a passage through the bolt communicating with the pocket for introducing fluid into the pocket to urge the panel away from the wall and into the pocket.

22. The intracranial bolt according to claim 21 wherein the panel extends circumferentially around the bore.

23. A method of performing a medical procedure on the brain comprising:

forming an opening in the skull;

installing an intracranial bolt in the opening in the skull, the intracranial bolt having a distal portion adapted to be secured in the opening in the skull, a proximal portion adapted to project from the skull when the bolt is installed in the opening, and a bore extending between the proximal and distal sections for providing access to the brain through the bolt;

securing a cap on the proximal end of the bolt; and

removing the cap after installation of the bolt and inserting a medical device through the bore in the bolt to perform a medical procedure on the brain.

24. The method according to claim 23 wherein the step of inserting a medical device through the bore in the bolt comprises inserting a cannula through the bore and into the brain to provide a pathway;

and further comprising the step of replacing the cap on the bolt after the installation of the cannula.

25. A method of placing and temporarily anchoring a medical device through a skull and into a brain, the method comprising:

forming an opening in the skull;

installing an intracranial bolt in the opening in the skull, the bolt having a bore therethrough for the passage of a medical device, and an inflatable member in the bore which when inflated engages a medical device in the bore;

inserting a medical device through the bore of the bolt and into the brain; and

inflating the inflatable member to engage the device, and releasably anchor the device.

26. The method according to claim 25, wherein the bolt is adapted to mount a cap, and further comprising the step of securing a cap on the bolt after the medical device has been inserted into the bore.

27. The method according to claim 25 wherein the inflatable member comprises a panel of flexible sheet material secured over a portion of the wall of the bore to form a pocket between the panel and wall, and wherein the step of inflating the inflatable member comprises introducing fluid into the pocket to urge the flexible panel away from the wall and into the bore to engage the medical device in the bore.

28. The method according to claim 27 wherein the panel extends circumferentially around the wall of the bore.