Self-deploying catheter assembly

• US 6,589,208 B2
• Filed: 05/30/2001
• Issued: 07/08/2003
• Est. Priority Date: 06/20/2000
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Ewers, Richard C., Pravong, Boun, Dulak, Gary R.
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/870,255
• Publication Number:
  US 20010056273A1
• Time in Patent Office: 769 Days
• Field of Search: 604/95.01, 604/104, 604/109, 604/164.01, 604/164.04, 604/96.01, 604/102.01, 604/177, 604/174, 604/107, 606/232, 606/191, 606/198
• US Class Current: 604/104
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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

A self-deploying catheter assembly comprises an anchoring device mounted to a tube. A distal end of the anchoring device is held in a fixed position by a releasable suture while a proximal end is freely movable between a proximal position and a distal position defined by a stop on the tube. During insertion into a body cavity, the anchor automatically maintains a low-profile state with the ends spaced apart. Once fully inserted, the anchor self converts into a high-profile state when the tube is slightly withdrawn, bringing the ends closer together. The suture is disengaged to release the distal end of the anchor in order to facilitate a low-profile state for withdrawal of the assembly.

Claims

1. A method of inserting a medical instrument through a body conduit and for anchoring the medical instrument in a body cavity, comprising the steps of:

providing an elongate tube having a shaft proximal end and a shaft distal end;

affixing a stop along the tube at an anchoring position;

forming an anchoring device with an anchor proximal end and an anchor distal end;

providing the anchoring device with characteristics including a high-profile state when the anchor proximal end and the anchor distal end are in a generally proximate relationship, and a low-profile state when the anchor proximal end and the anchor distal end are in a generally spaced relationship;

mounting the anchoring device relative to the tube with the anchor distal end movable between a distal end proximal position distal of the stop and a distal end distal position distal of the tube, and with the anchor proximal end movable between a proximal end proximal position and a proximal end distal position proximal of the stop;

inserting the tube into the body conduit toward the body cavity; and

during the inserting step, moving the anchor proximal end to the proximal end proximal position with the anchor distal end at the distal end proximal position to maintain the anchoring device in the low-profile state.

2. The method in claim 1, further comprising the steps of:

positioning the tube with the stop in the body cavity; and

withdrawing the tube sufficiently to move the anchor proximal end to the proximal end distal position and to provide the anchoring device with its high profile characteristics.

3. The method in claim 2, wherein the step of withdrawing the tube comprises the step of moving the anchor proximal end to the proximal end distal position within the body cavity.

4. The method in claim 2, further comprising the step of releasably locking the distal end of the anchoring device in the distal end proximal position.

5. The method in claim 4, further comprising the steps of:

retracting the tube from the body cavity;

during the retracting step, releasing the anchor distal end from the distal end proximal position; and

after the releasing step, moving the anchor distal end to the distal end distal position to space the anchor distal end from the anchor proximal end so as to provide the anchoring device with its low-profile characteristics during the retracting step.

6. The method in claim 5, wherein:

the releasably locking step comprises the step of coupling the anchor distal end to a suture engaged in a proximal direction; and

the releasing step comprises the step of disengaging the suture from the proximal direction.

7. The method in claim 1, wherein the step of forming an anchoring device comprises the step of forming a bulb.

8. The method in claim 1, wherein the step of forming an anchoring device comprises the step of forming a hinged wing structure.

9. The method in claim 1, wherein the step of forming an anchoring device comprises the step of forming a spiral.

10. The method in claim 1, further comprising the step of draining fluid from the body cavity with the anchoring device and the tube.

11. A method for inserting a catheter assembly through a body conduit and automatically deploying the assembly in a body cavity, the method comprising the steps of:

coupling an anchoring device with an anchor proximal end and an anchor distal end to a tube;

providing the anchoring device with characteristics ranging between a high-profile state when the anchor proximal end and the anchor distal end are in a generally proximate relationship, and a low-profile state when the anchor proximal end and the anchor distal end are in a generally spaced relationship;

disposing a stop on the tube between the anchor proximal end and the anchor distal end;

automatically forming the low-profile state upon inserting the anchoring device into the body conduit; and

automatically forming the high-profile state upon disposal of the anchoring is device in the body cavity.

12. The method of claim 11, wherein the step of automatically forming the low-profile state comprises the step of forming the low-profile state only by inserting the tube in a distal direction.

13. The method of claim 11, wherein the step of automatically forming the high-profile state comprises the step of forming the high-profile state only by moving the tube in a proximal direction once the anchoring device is disposed in the body conduit without any manual manipulation of the anchoring device.

14. The method of claim 11, further comprising the step of:

once disposed in the body cavity, moving the anchor distal end from a distal end proximal position adjacent to the stop to a distal end distal position away from the stop to facilitate the low-profile state for removal of the anchoring device.

15. The method of claim 14, wherein the step of moving the anchor distal end from the distal end proximal position to the distal end distal position comprises the step of releasing a lock adapted to hold the anchor distal end in the distal end proximal position.

16. A catheter assembly movable with a medical device through a body conduit for anchoring the medical device in a body cavity, comprising:

an elongate tube associated with the medical device and having a shaft proximal end and a shaft distal end;

a stop fixed to the tube generally at a position desired for anchoring the tube;

an anchoring device carried by the tube and having an anchor distal end distal of the stop, and an anchor proximal end proximal of the stop;

the distal end of the anchoring device being movable between a distal end proximal position and a distal end distal position;

the anchor proximal end being movable between a proximal end proximal position and a proximal end distal position; and

a releasable lock operable from the shaft proximal end to hold the anchor distal end in the distal end proximal position to facilitate insertion in a low-profile state and anchoring in a high-profile state, the lock being operable to release the anchor distal end from the distal end proximal position to the distal end distal position to facilitate withdrawal of the medical device with the anchoring device in the low-profile state.

17. The assembly of claim 16, wherein the anchoring device comprises a bulb made of a liquid permeable material.

18. The assembly of claim 16, wherein the tube comprises apertures disposed at a position between the proximal end and the distal end of the anchoring device.

19. A self-deployable catheter assembly, comprising:

a tube with a shaft proximal end and a shaft distal end;

a stop fixed to the tube at a stop position between the shaft proximal end and the shaft distal end;

an anchoring device carried by the tube and having an anchor distal end distal of the stop, and an anchor proximal end proximal of the stop, the anchoring device being movable between a low-profile state and a high-profile state; and

a releasable lock operable to hold the anchor distal end in a distal end proximal position to facilitate insertion in the low-profile state and anchoring in the high-profile state, the lock being operable to release the anchor distal end from the distal end proximal position to a distal end distal position to facilitate withdrawal in the low-profile state.

20. The assembly of claim 19, wherein the anchoring device comprises a bulb.

21. The assembly of claim 19, wherein the anchoring device comprises a hinged wing structure.

22. The assembly of claim 19, wherein the anchoring device comprises a spiral.

23. The assembly of claim 19, wherein the anchor proximal end is freely movable between a proximal end distal position adjacent to the stop, and a proximal end proximal position spaced apart from the stop.

24. The assembly of claim 19, further comprising a slide coupled to the anchor proximal end.

25. The assembly of claim 19, further comprising a slidable bushing coupled to the anchor distal end.

26. The assembly of claim 19, wherein the releasable lock comprises a suture.

27. A catheter assembly, comprising:

a tube; and

an anchoring device mounted to the tube, the anchoring device having;

an anchor distal end held in a fixed position by a releasable lock,

an anchor proximal end freely movable between a proximal end proximal position and a proximal end distal position, the proximal end distal position being defined by a stop disposed on the tube between the anchor distal end and the anchor proximal end,

a high-profile state when the anchor distal end and the anchor proximal end are in a generally proximate relationship, and

a low-profile state when the anchor distal end and the anchor proximal end are in a generally spaced relation ship, wherein the anchor distal end is movable to a released position distal of the fixed position upon releasing the lock.

28. The assembly of claim 27, wherein:

the anchoring device is liquid permeable; and

the tube comprises apertures disposed between the anchor proximal end and the anchor distal end.