Anchoring nerve block catheter

• US 9,511,206 B2
• Filed: 07/05/2015
• Issued: 12/06/2016
• Est. Priority Date: 01/18/2013
• 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.
• Inventors: Hofius, Jonathan, Kothari, Manish, Qiu, Chunyuan, Garcia, Pablo E., Koenig, Karen S.
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/791,460
• Publication Number:
  US 20150306350A1
• Time in Patent Office: 520 Days
• Field of Search: 607/46, 607116-154, 606/32, 606/33
• US Class Current: 1/1
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• 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 25/0026 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 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

The invention relates to medical devices and, particularly, catheter medical devices. In an aspect is a nerve block catheter system comprising a dual-sheath catheter comprising an inner sheath and an outer sheath, wherein distal ends of the sheaths are connected, the inner sheath defines a fluid delivery lumen, and the outer sheath comprises a tissue lock movable between a collapsed position and an extended position, wherein the tissue lock forms a reversible tissue anchor when in the extended position, and an actuator connected to the proximate end of the catheter and configured to activate the tissue lock by sliding the outer sheath length-wise relative to the inner sheath.

Claims

1. An anchoring nerve block catheter system comprising:

(A) a dual-sheath catheter comprising an inner sheath and an outer sheath, wherein the catheter and sheaths have proximate and distal ends, wherein the distal ends of the sheaths are connected, the inner sheath defines a fluid delivery lumen, and the outer sheath comprises a tissue lock movable between a collapsed position and an extended position, wherein the tissue lock forms a reversible tissue anchor when in the extended position, and

(B) an actuator connected to the proximate end of the catheter and configured to activate the tissue lock by sliding the outer sheath length-wise relative to the inner sheath,

wherein the tissue lock is a malecot and the outer sheath comprises a plurality of parallel length-wise slits defining a plurality of malecot extensions, and each of the extensions comprises one or more living hinges operable to increase the force exerted by the extensions on surrounding tissue, and the catheter comprises a coil configured to;

(a) provide echogenicity, wherein the coil is embedded in the inner sheath;

(b) provide a bidirectional antenna configured to deliver electrical energy to a nerve and to transmit internal electricity from nerve electrical activities;

or (c) improve anti-kinking of the catheter in locations prone to kinking, wherein the coil has a length and varied wraps per inch length-wise or varied thickness along the length of the coil, and at least one of the following;

(i) the catheter system comprises one or more protrusions at a skin entry point along the outer sheath configured to prevent backflow leakage of anesthetic;

(ii) the catheter system comprises a weak point in the tissue lock promoting collapse of the tissue lock above an axial force or upon accidental removal of the catheter without deactivating the tissue lock;

(iii) the catheter system further comprises a lip or edge on the distal end of the catheter that forms over a lip or edge of a needle inserted through the inner sheath and is operative to avoid deploying the anchor during insertion;

or

(iv) the catheter system further comprises a coating on the tissue lock of a tissue ingrowth inhibitor substance sufficient to inhibit tissue ingrowth, wherein the substance is hyalase, glucocorticoids, methotrexate, or an allium cepa extract gel.

2. The catheter system of claim 1, wherein the catheter is configured, when deployed in tissue with the tissue anchor activated, to apply a radial force to the tissue and therefore resist axial movement from an axial force of at least 200 g with earth surface gravity.

3. The catheter system of claim 1, wherein the coil is configured to provide echogenicity, wherein the coil is embedded in the inner sheath.

4. The catheter system of claim 1, wherein a wall of the catheter has a durometer or thickness that is varied to improve anti-kinking.

5. The catheter system of claim 1, further comprising (a) a coating on the tissue lock of a tissue ingrowth inhibitor substance sufficient to inhibit tissue ingrowth;

(b) an anti-bacterial coating on the tissue lock.

6. The catheter system of claim 1, wherein the inner sheath is configured to reduce or block fluid from leaking through the tissue lock when in the extended position.

7. The catheter system of claim 1, comprising one or more protrusions at a skin entry point along the outer sheath configured to prevent backflow leakage of anesthetic.

8. The catheter system of claim 1, wherein the tissue lock comprises living hinges at each end and in the middle of each malecot extension operative to strengthen the malecot extensions when in the extended position.

9. The catheter system of claim 1, comprising a weak point in the tissue lock promoting collapse of the tissue lock above an axial force or upon accidental removal of the catheter without deactivating the tissue lock.

10. The catheter system of claim 1, wherein the actuator is a squeeze-type bi-stable mechanism configured such that when squeezed after implantation, it deactivates, thus preventing removal of the catheter without deactivation.

11. The catheter system of claim 1, further comprising a lip or edge on the distal end of the catheter that forms over a lip or edge of a needle inserted through the inner sheath and is operative to avoid deploying the anchor during insertion.

12. The catheter system of claim 1, wherein a fiberoptic camera or lens is positioned through the catheter and configured to directly visualize a nerve or bolus post-block to ensure correct placement, or configured to detect the nerve.

13. The catheter system of claim 1, further comprising an echogenic coating on the catheter distal end or tissue lock configured to improve echogenicity of the catheter distal end or tissue lock.

14. The catheter system of claim 1, wherein the coil is configured to provide a bidirectional antenna configured to deliver electrical energy to a nerve and to transmit internal electricity from nerve electrical activities.

15. The catheter system of claim 1, wherein the coil is configured to improve anti-kinking of the catheter in locations prone to kinking, wherein the coil has a length and varied wraps per inch length-wise or varied thickness along the length of the coil.

16. The catheter system of claim 1, wherein the inner sheath comprises one or more exit ports at the tissue lock to allow multiple exit points for fluid.

17. The catheter system of claim 1, further comprising an anti-bacterial coating on the tissue lock that is silver or copper particles or chitosan.

18. The catheter system of claim 1, further comprising a coating on the tissue lock of a tissue ingrowth inhibitor substance sufficient to inhibit tissue ingrowth, wherein the substance is hyalase, glucocorticoids, methotrexate, or an allium cepa extract gel.

19. A method of using the nerve block catheter system of claim 1, the method comprising the following steps:

navigating the nerve block catheter system so that the distal tip of the catheter is within pharmacological proximity to a nerve;

engaging the tissue lock; and

delivering a medicament.

20. A method of making a nerve block catheter system of claim 1, comprising assembling the catheter or system from one or more components.