Indwelling nerve block catheters

• US 8,825,129 B2
• Filed: 03/05/2011
• Issued: 09/02/2014
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: SRI International, Inc., Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: SRI International, Inc., Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Garcia, Pablo E., Qiu, Chunyuan, Young, Sarah J., Shakespear, Karen Frances, Dutta, Sanjeev, Krane, Elliot, Ramamurthi, Radhamangalam J
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/041,387
• Publication Number:
  US 20110218529A1
• Time in Patent Office: 1,277 Days
• Field of Search: 600/373, 600/372, 600/375, 600/377, 600/378, 600/554, 606/129, 607/116, 607/126, 607/118, 604/512
• US Class Current: 600/373
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A nerve block catheter system employs an indwelling, flexible catheter comprising a tissue lock to retain the catheter tip in pharmacologically proximity to a target nerve and optionally, a decoupler that insulates the tip of the catheter from proximal tissue movement.

Claims

1. A nerve block catheter system comprising a flexible indwelling nerve block catheter and a rigid stylet, the catheter and stylet each comprising a proximal portion and a distal portion terminating in a distal tip, wherein:

(a) the distal portion of the catheter comprises a tissue lock which engages target site tissue and thereby anchors the catheter to the target site tissue without axially advancing or retracting the catheter tip whereby the catheter tip is retained in pharmacological proximity to a target nerve, and the proximal portion of the catheter comprises an actuator of the tissue lock,

(b) the stylet is insertable axially in the catheter, providing rigidity to the catheter system during placement,

(c) the distal tip of the stylet is sufficiently sharp to push through to the target site tissue, and

(d) the distal portion of the catheter and/or stylet comprises an electrode that senses and/or stimulates nerve electrical activity for placement, wherein;

the tissue lock is reversible and reversibly engages the target site tissue without axially advancing or retracting the catheter tip,

the tissue lock comprises one or more protrusions and the actuator alternatively causes the protrusions to engage or disengage the target site tissue,

the protrusions are bulges, the catheter comprises an inner sheath and outer sheath, and one or more sections of the outer sheath are made of a compliant material that bulges outward to form the bulges when the outer sheath is axially compressed,

the actuator comprises a mechanism that causes the outer sheath to compress axially, and the system further comprises a skin-mounted decoupler that insulates the tip of the catheter from proximal tissue movement.

2. The nerve block catheter system of claim 1 wherein the actuator mechanism comprises a rotatable knob wherein rotation of the knob alternatively causes the tissue lock to engage or disengage the target site tissue.

3. The nerve block catheter system of claim 2 wherein the catheter contains an anesthetic or an analgesic.

4. A method of using the nerve block catheter system of claim 3, comprising steps:

tracking the target nerve of a patient with the electrode;

placing the catheter so that the catheter tip is in pharmacological proximity to the target nerve;

engaging the tissue lock whereby the catheter tip is retained in pharmacological proximity to the target nerve; and

delivering the anesthetic or analgesic through the catheter tip directly to the target nerve.

5. The method of claim 4 further comprising steps:

detecting a resultant anesthetic or analgesic effect;

disengaging the tissue lock; and

removing the catheter from the patient.

6. The nerve block catheter system of claim 1 wherein the actuator mechanism is a lever or button, wherein pushing or pulling on the lever or button alternatively causes the tissue lock to engage or disengage the target site tissue.

7. The nerve block catheter system of claim 6 wherein the catheter contains an anesthetic or an analgesic.

8. A method of using the nerve block catheter system of claim 7, comprising steps:

tracking the target nerve of a patient with the electrode;

placing the catheter so that the catheter tip is in pharmacological proximity to the target nerve;

engaging the tissue lock whereby the catheter tip is retained in pharmacological proximity to the target nerve; and

delivering the anesthetic or analgesic through the catheter tip directly to the target nerve.

9. The method of claim 8 further comprising steps:

detecting a resultant anesthetic or analgesic effect;

disengaging the tissue lock; and

removing the catheter from the patient.

10. The nerve block catheter system of claim 1 wherein the actuator mechanism comprises a thread that causes the outer sheath to compress axially as the outer sheath is rotated relative to the inner sheath.

11. The nerve block catheter system of claim 1 wherein the decoupler comprises a hub comprising a cylindrical chamber that absorbs axial movement of the catheter.

12. The nerve block catheter system of claim 11 wherein the catheter contains an anesthetic or an analgesic.

13. A method of using the nerve block catheter system of claim 12, comprising steps:

tracking the target nerve of a patient with the electrode;

placing the catheter so that the catheter tip is in pharmacological proximity to the target nerve;

engaging the tissue lock whereby the catheter tip is retained in pharmacological proximity to the target nerve; and

delivering the anesthetic or analgesic through the catheter tip directly to the target nerve.

14. The method of claim 13 further comprising steps:

detecting a resultant anesthetic or analgesic effect;

disengaging the tissue lock; and

removing the catheter from the patient.

15. The nerve block catheter system of claim 1 wherein the catheter proximal portion comprises a hydrogel to decouple the catheter tip from movement of surrounding muscle or skin.

16. The nerve block catheter system of claim 1 wherein the electrode is one of a plurality of independent electrodes of the system that resolve electric fields of the target nerve for placement.

17. The nerve block catheter system of claim 1 wherein the one or more bulge sections has cuts to aid in tissue engagement.

18. The nerve block catheter system of claim 17 wherein the catheter contains an anesthetic or an analgesic.

19. A method of using the nerve block catheter system of claim 18, comprising steps:

tracking the target nerve of a patient with the electrode;

placing the catheter so that the catheter tip is in pharmacological proximity to the target nerve;

engaging the tissue lock whereby the catheter tip is retained in pharmacological proximity to the target nerve; and

delivering the anesthetic or analgesic through the catheter tip directly to the target nerve.

20. The method of claim 19 further comprising steps:

detecting a resultant anesthetic or analgesic effect;

disengaging the tissue lock; and

removing the catheter from the patient.

21. The nerve block catheter system of claim 1 wherein the catheter contains an anesthetic or an analgesic.

22. A method of using the nerve block catheter system of claim 21, comprising steps:

tracking the target nerve of a patient with the electrode wherein the tracking comprises sensing nerve native or evoked electrical activity with the electrode;

placing the catheter so that the catheter tip is in pharmacological proximity to the target nerve;

engaging the tissue lock whereby the catheter tip is retained in pharmacological proximity to the target nerve; and

delivering the anesthetic or analgesic through the catheter tip directly to the target nerve.

23. The method of claim 22 further comprising steps:

detecting a resultant anesthetic or analgesic effect;

disengaging the tissue lock; and

removing the catheter from the patient.

24. The method of claim 23 comprising the steps of stimulating nerve activity with the electrode and detecting resultant patient movement or sensation.

25. The method of claim 22 comprising the steps of stimulating nerve activity with the electrode and detecting resultant patient movement or sensation.