System for enhancing visibility in the epidural space

• US 6,470,209 B2
• Filed: 07/13/1999
• Issued: 10/22/2002
• Est. Priority Date: 07/06/1992
• Status: Expired due to Fees

• Current Assignee: Catheter Imaging Systems Incorporated
• Original Assignee: Catheter Imaging Systems Incorporated
• Inventors: Snoke, Phillip Jack
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/351,388
• Publication Number:
  US 20020007144A1
• Time in Patent Office: 1,197 Days
• Field of Search: 604/95.01, 604/95.04, 604/523, 600/101, 600/139, 600/141, 600/144, 600/146-151, 600/153, 600/156, 600/160, 600/476, 600/478
• US Class Current: 600/478
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 1/12 with cooling or rinsing arrangements
• CPC Class Codes: A61B 1/3132 for laparoscopy
• 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 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

A method of epidural surgery is provided that improves visibility in the epidural space of a patient for more effectively conducting therapeutic surgery therein. The method includes the steps of distending a portion of the epidural space of a patient by filling the portion of the epidural space with a fluid supplied from a catheter and positioning a portion of an optical scope in the distended portion of the epidural space by inserting the optical scope through the same catheter that supplies the distending fluid to thereby provide a visual image of the epidural space.

Claims

1. A system for enhancing visibility in the epidural space, the system comprising:

a steerable catheter having a handle portion, a tube portion connected to the handle portion and extending outwardly therefrom, and steering means connected to at least the handle portion for steering distal end portions of the tube portion;

said tube portion having a plurality of lumen formed therewithin, including at least a first working lumen and a second working lumen, each of said first and second working lumens having distinct, non-coincident longitudinal axes and being separated from each other by a portion of the elongate tube portion,

each of said first and second working lumens being substantially symmetrically positioned along both sides of said tube diameter,

a fiber optic scope positioned to extend through the second working lumen of the steerable catheter;

said first working lumen positioned within the steerable catheter for continuously supplying fluid under pressure to the epidural space and for distending the epidural space so that the epidural space is maintained in a distended state to enhance visibility when the fiber optic scope is positioned in the second working lumen of the steerable catheter; and

an imaging apparatus connected to the fiber optic scope to display images from the fiber optic scope when said scope is positioned in the second working lumen of the steerable catheter.

2. A system as defined in claim 1, wherein the handle portion includes a plurality of access portions formed therein, and wherein the plurality of access portion is in fluid communication with at least each of said first and second working lumens, respectively amongst said plurality of lumen.

3. A system as defined in claim 2, wherein said first working lumen includes means connected to the steerable catheter for supplying a continuous pressure to a fluid in communication with the steerable catheter to maintain fluid pressure through the catheter to the epidural space thereby ensuring a continuous flow of fluid to distend and maintain in a distended state the epidural space.

4. A system as defined in claim 1, wherein the first working lumen includes means connected to the steerable catheter for maintaining the epidural space in a distended state while avoiding contact between the tube portion of the steerable catheter and structures within the epidural space when the tube portion is positioned within the epidural space.

5. The invention as defined in claim 1, wherein the system further includes a continuous fluid supplier in operable engagement with said first working lumen to continuously supply fluid to the epidural space to thereby maintain the epidural space in a distended state to enhance visibility when the fiber optic scope is positioned in the tube portion of the steerable catheter.

6. The invention as defined in claim 1, wherein the system further includes a continuous pressure supplier in operable engagement with said first working lumen to supply a continuous pressure to a fluid in communication with the steerable catheter so as to maintain fluid pressure through the catheter to the epidural space thereby ensuring a continuous flow of fluid to distend and maintain in a distended state the epidural space.

7. A system for enhancing visibility in the epidural space, the system comprising:

a steerable catheter comprising

a handle,

a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,

each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,

each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and

a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;

an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and

an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising

a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and

an image display device connected to the flexible fiber optic scope to display images of the epidural space.

8. A system for enhancing visibility in the epidural space as defined in claim 7, wherein the epidural space distender further comprises a fluid pressure regulator connected to the fluid pressure supply to regulate the fluid pressure supplied to the epidural space at a rate sufficient to maintain the epidural space in a distended state.

9. A system as defined in claim 8, wherein the fluid pressure supply of the epidural space distender comprises a pliable container in fluid communication with the first working lumen of the tube.

10. A system as defined in claim 9, wherein the fluid pressure regulator comprises a stop-cock interposed between and in fluid communication with the fluid pressure supply and the first working lumen of the tube, the stop-cock having at least one access port adapted to be coupled with a syringe having a volumetric capacity of at least twenty cubic centimeters (20 cc).

11. A system as defined in claim 8, wherein the fluid pressure supply of the epidural space distender comprises a variable pressure fluid container having a distal end positioned to be in fluid communication with the first working lumen of the tube and a proximal end connected to the fluid pressure regulator, the fluid pressure regulator positioned to selectively change the variable fluid pressure of the container.

12. A system as defined in claim 11, wherein the epidural space distender comprises a syringe.

13. A system as defined in claim 7, wherein each of the first and second working lumen having a cross-sectional diameter, the cross-sectional diameter of each of the first and second working lumen being substantially coincident with the diameter of said tube.

14. A system as defined in claim 13, wherein the cross-sectional diameter of the first working lumen is substantially different from the cross-sectional diameter of the second working lumen.

15. A system as defined in claim 7, wherein the epidural space distender comprises a syringe.

16. A system as defined in claim 15, wherein the tube connected to the handle and extending outwardly therefrom defines a first handle and wherein the epidural space distender comprises a second tube, the second tube extending outwardly from the handle, being in fluid communication with the first tube, and having a distal end connected to and in fluid communication with the syringe.

17. A system as defined in claim 7, wherein the handle portion comprises a top portion, at least one side portion extending therefrom in a direction substantially perpendicular to the top portion, and a bottom portion connected to the at least one side portion, the handle further having a medial lateral extent, a distal end lateral extent, and a proximal end lateral extent, and wherein the medial lateral extent is less than both the distal end lateral extent and the proximal end lateral extent to thereby provide the handle a substantially hour-glass configuration readily held in the hand of a user.

18. A system for enhancing visibility in the epidural space, the system comprising:

a steerable catheter comprising;

a handle,

first and second tubes each connected to the handle and extending outwardly therefrom, the first tube having a tube diameter, a flexible distal portion and at least two lumen defining first and second working lumen extending substantially parallel to each other lengthwise therein, and the second tube having at least one working lumen positioned to be in fluid communication with at least one of the working lumen of the first tube,

each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,

each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and

a controller connected to the handle to control flexible movement of the flexible distal portion of the first tube;

an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and

an epidural space imager associated with the steerable catheter to provide visual images of the epidural space, the imager comprising;

a flexible fiber optic scope positioned to extend through the second working lumen of the first tube, the first tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and

an image display device connected tot he flexible fiber optic scope to display images of the epidural space.

19. A system as defined in claim 18, wherein the handle has an upper portion, a side portion connected to the upper portion, and a lower portion connected to the side portion and underlying the upper portion, wherein the controller is at least partially contained within the handle and includes at least one lobe extending outwardly from the side portion of the handle such that the at least one lobe is readily accessible to a user holding the handle to thereby assist the user in controlling the flexing of the flexible distal portion of the first tube by the user moving the at least one lobe.

20. A system as defined in claim 19, wherein the controller comprises a control wheel having a peripheral portion, the at least one lobe connected to and extending outwardly from the peripheral portion of the control wheel.

22. A system as defined in claim 20, wherein the at least one lobe extends through the side portion of the handle.

23. A system as defined in claim 19, wherein the system further includes an indicator associated with the upper portion of the handle and responsive to the controlled flexing of the flexible distal portion of the first tube to thereby indicate the angular attitude of the flexible distal portion of the first tube.

24. A system as defined in claim 23, wherein the indicator is connected to the controller and positioned on the upper portion of the handle.

25. A system as defined in claim 19, wherein the at least one lobe extends through the side portion of the handle.

26. A system as defined in claim 18, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the first tube.

21. A system for enhancing visibility in the epidural space, the system comprising;

a steerable catheter comprising

a handle,

a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,

each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,

each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and

a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;

an indicator associated with the handle and responsive to the controlled flexing of the flexible distal portion of the tube to thereby indicate the angular attitude of the flexible distal portion of the tube;

an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and

an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising;

a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and

an image display device connected to the flexible fiber optic scope to display images of the epidural space.

31. A system as defined in claim 21, wherein the handle includes a top outer surface portion, wherein the indicator comprises a tip direction indicator having a substantially flat outer surface substantially parallel to the top outer surface portion, and wherein the outer surface of the tip direction indicator rotates clockwise and counterclockwise in response to the controller to thereby indicate the angular attitude of the flexible distal portion of the tube.

32. A system as defined in claim 21, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the tube.

27. A system for enhancing visibility in the epidural space, the system comprising:

a steerable catheter comprising

a handle having an upper portion, a side portion connected to the upper portion, and a lower portion connected to the side portion and underlying the upper portion,

a tube connected to the handle and extending outwardly therefrom, the tube having a tube diameter, a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,

each of said first and second working lumen hating distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,

each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter, and

a controller at least partially contained within the handle, the controller including at least one lobe connected to and extending from the side portion of the handle such that the at least one lobe is readily accessible to user holding the handle to thereby assist the user in controlling the flexing of the flexible distal portion of the first tube by the user moving the at least one lobe;

an epidural space distender comprising a fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and

an epidural space imager associated with the steerable catheter to provide visual images of the distended epidural space, the imager comprising

a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope, and

an image display device connected to the flexible fiber optic scope to display images of the epidural space.

28. A system as defined in claim 27, wherein the system further includes an indicator associated with the handle, the indicator responsive to the controlled flexing of the flexible distal portion of the tube to thereby indicate the angular attitude of the flexible distal portion of the tube.

29. A system as defined in claim 28, wherein the indicator is connected to the controller and positioned on the upper portion of the handle.

30. A system as defined in claim 27, wherein the system includes at least two access ports formed in the handle, each of the at least two access ports being in fluid communication with a corresponding one of the working lumen of the tube.

33. A system for enhancing visibility in the epidural space, the system comprising:

a steerable catheter comprising

a handle,

a tube having a tube diameter, said tube being connected to the handle and extending outwardly therefrom, the tube having a flexible distal portion and at least two lumen defining first and second working lumen extending lengthwise through the tube from the proximal end to the distal end thereof and being substantially parallel to each other,

each of said first and second working lumen having distinct, non-coincident longitudinal axes, and being separated from each other by a portion of the tube,

each of said first and second working lumen being substantially symmetrically positioned along both sides of said tube diameter,

each of the first and second working lumen having a cross-sectional diameter, the cross-sectional diameter of each of the first and second working lumen being substantially coincident with the tube diameter, and

a controller connected to the handle to control flexible movement of the flexible distal portion of the tube;

an epidural space distender comprising a fluid pressure supply positioned to supply fluid pressure through the first working lumen to the epidural space to thereby distend the epidural space and maintain the epidural space in a distended state responsive to the fluid pressure; and

an epidural space imager associated with the steerable catheter to enable viewing of the distended epidural space, the imager comprising a flexible fiber optic scope positioned to extend through the second working lumen of the tube, the tube being responsive to the controller and positioned to flex independently of the movement of the flexible fiber optic scope.

34. A system as defined in claim 33, wherein the cross-sectional diameter of the first working lumen is substantially different from the cross-sectional diameter of the second working lumen.

35. A system as defined in claim 33, herein the cross-sectional diameter of the first working lumen is substantially equal to the cross-sectional diameter of the second working lumen.