Steerable fiberoptic epidural balloon catheter and scope

• US 7,273,468 B2
• Filed: 01/05/2001
• Issued: 09/25/2007
• Est. Priority Date: 01/06/2000
• Status: Expired due to Term

• Current Assignee: Advanced Pain Center, LLC.
• Original Assignee: Raymond L. Bedell
• Inventors: Bedell, Raymond L.
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/169,641
• Publication Number:
  US 20030004460A1
• Time in Patent Office: 2,454 Days
• Field of Search: 604/95.04, 604/96.01, 604 9701- 9903, 604/164.13, 604/264, 604/523, 604/528, 604/510, 600/434, 600/585, 600/114, 600/115, 600146-150, 600160-183, 606/15, 606/16
• US Class Current: 604/95.04
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00085 Baskets
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Devices for and methods of treating afflictions occurring in a body cavity, such as the epidural space. The methods and devices provide for fluoroscopic assisted placement of a fiber optic catheter/scope with a balloon tip. These devices and methods would perform decompression surgery, neuroplasty, and mechanical lysis of adhesions (and other afflictions), as well as allowing small operating and therapeutic instruments under direct visualization.

Claims

1. A medical device for treating disorders within an epidural space, comprising:

a body;

a catheter portion connected to said body at a proximal end and extending from said body to a distal end;

an inflatable member disposed on an exterior surface of said catheter portion and spaced away from said distal end, such that said distal end of said catheter extends beyond said inflatable member so as to penetrate patient tissue ahead of said inflatable member during use; and

a steering mechanism integrated into said catheter portion, wherein the catheter portion is flexible and the steering mechanism controls an angle of the distal end with respect to an adjacent segment of said catheter portion such that said distal end and said inflatable member can be steered without, or after being advanced beyond an end of, a guidewire;

an optical system, connected to said body, configured to obtain an image of said epidural space around said distal end of said catheter and provide that image to an operator of said medical device;

wherein said medical device is specifically configured for treating disorders within an epidural space with minimal damage to a patient.

2. The device of claim 1, wherein the inflatable member comprises at least one balloon.

3. The device of claim 1, wherein said optical system comprises fiber optics extending through said catheter portion to said distal end.

4. The device of claim 1, further comprising a reservoir in said body from which said inflatable member is inflated using controls on said body.

5. The medical device of claim 4, wherein said body is shaped like a gun and said balloon is inflated by actuating a trigger at a handle portion of said body.

6. The device of claim 1, further comprising a tube running through said catheter portion for delivering an instrument or fluid to said distal end of said catheter portion.

7. The medical device of claim 1, wherein said body has an L-shape.

8. The medical device of claim 1, wherein said steering mechanism comprises wires extending through said catheter portion to said distal end.

9. The medical device of claim 1, wherein said inflatable member extends along a length of said catheter portion away from said distal end.

10. The medical device of claim 1, wherein said both forward and rearward ends of said inflatable member are attached to said catheter portion such that, when inflated, a middle portion of said inflatable member experiences the most expansion.

11. The medical device of claim 10, wherein when said middle portion of said inflatable member reaches a maximum radial expansion, the inflatable member then expands longitudinally.

12. A method of operating a medical device to treat an epidural space of a patient, wherein said medical device includes

a body,

a catheter portion extending from said body and having a distal end,

an optical system, connected to said body, configured to obtain an image of said epidural space around said distal end of said catheter and provide that image to an operator of said medical device;

a steering mechanism integrated into said catheter portion, and

an inflatable member disposed along said catheter portion and spaced away from said distal end,

said method comprising;

inserting said distal end of said catheter into said epidural space of said patient;

obtaining an image of said epidural space with said optical system to locate an area of said epidural space to be treated;

penetrating tissue in said epidural space with said distal end of said catheter portion by applying force to said body of said device;

then inflating said inflatable member disposed along said catheter portion behind said distal end in tissue already penetrated by said distal end to apply pressure to the penetrated tissue, and

steering the catheter portion with the steering mechanism inside said epidural space to locate said tissue that is penetrated with said distal end, wherein the catheter portion is flexible and the steering mechanism controls an angle of the distal end with respect to an adjacent segment of said catheter portion such that said distal end and said inflatable member can be steered without, or after being advanced beyond an end of, a guidewire.

13. The method of claim 12, wherein said tissue penetrated comprises a lesion in said epidural space.

14. The method of claim 12, further comprising providing fluid or an instrument to said distal end through a tube in said catheter portion.

15. The method of claim 12, further comprising rupturing said penetrated tissue with inflation of said inflatable member.

16. The catheter of claim 12, wherein said steering mechanism comprises a plurality of wires for steering said shaft by controlling an orientation of said tip.

17. The method of claim 12, further comprising inflating said inflatable member to less than 250 mm Hg to avoid damage to nerves or dura in said epidural space.

18. The method of claim 12, further comprising rupturing fibrosis of an epidural lesion with inflation of said inflatable member.

19. The method of claim 12, further comprising dilating the epidural space with inflation of said inflatable member.

20. The method of claim 12, further comprising removing scar tissue from the epidural space with inflation of said inflatable member.

21. The method of claim 12, wherein said penetrating tissue in said epidural space with said distal end of said catheter portion further comprising penetrating said tissue by applying force to said body by band of an operator of said device.

22. A medical device comprising:

a body comprising a locking collar;

a shaft connected to said body by said locking collar at a proximal end of said shaft and extending from said body to a tapered distal end that is configured to penetrate tissue to be treated, said distal end penetrating the tissue due to force applied by hand to said body by an operator of said device;

an inflatable member disposed on an exterior surface of said shaft and spaced away from said distal end, such that said tapered distal end of said shaft extends beyond said inflatable member so as to penetrate patient tissue ahead of said inflatable member during use, said shaft further comprising a fluid pathway for inflating said inflatable member by introducing fluid into said proximal end of said shaft at said body and delivering that fluid to said inflatable member, wherein the fluid is drawn from a closed reservoir disposed inside said body and having a specific, limited amount of fluid therein such that inflation of the inflatable member can be limited so as not to exceed a predetermined amount or pressure, said body further comprising a pump for moving fluid from said reservoir in said body to said inflatable member through a manifold anchored to said body and from said manifold into said fluid pathway;

a steering mechanism integrated into the shaft and controlled by controls on said body, wherein the distal end of said shaft is flexible and the steering mechanism controls an angle of the distal end with respect to an adjacent segment of the shaft such that said distal end and the inflatable member can be steered without, or after being advanced beyond an end of, a guidewire, said steering mechanism comprising wires passing trough ports in said manifold and extending along said shaft;

an optical system comprising at least one pathway integrated into the shaft through which illumination can be provided to said distal tip of said shaft and through which images can be obtained of an environment at the distal end of the shaft, said at least one optical pathway being connected to said manifold; and

a catheter integrated into the shaft through which either a tool or fluid can be introduced at the body and delivered at said distal end of the shaft,

wherein said device is specifically configured for use in an epidural space.