Imaging-guided anesthesia injection systems and methods

• US 9,044,542 B2
• Filed: 06/11/2012
• Issued: 06/02/2015
• Est. Priority Date: 12/21/2007
• Status: Expired due to Fees

• Current Assignee: Carticept Medical, Inc.
• Original Assignee: Carticept Medical, Inc.
• Inventors: Patrick, Timothy, Knostman, Richard, Axelrod, Michael, Ramey, Carribeth
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/493,910
• Publication Number:
  US 20130041258A1
• Time in Patent Office: 1,086 Days
• Field of Search: 604/82, 604/83, 604/85, 604/89, 604 65- 67, 604/131, 604/151, 604/152, 604/154, 604/155, 604257-259, 604/500, 604/506, 604/507, 604/511, 604518-520, 604/191
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/464 involving a plurality of displays
• CPC Class Codes: A61B 8/465 adapted to display user selection data, e.g. icons or menus
• CPC Class Codes: A61B 8/467 characterised by special input means
• CPC Class Codes: A61M 1/76 Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/246 being fixed along all or a part of its periphery
• CPC Class Codes: A61M 2202/0241 Anaesthetics; Analgesics
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2066 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61N 1/0502 : Skin piercing electrodes
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

Devices and systems for injecting fluids, such as anesthetics, to or near nerve tissue or other targeted anatomical location are disclosed herein. A conduit is generally configured to place the fluid delivery module in fluid communication with a needle that is configured to be inserted into the patient'"'"'s anatomy. One or more medicaments (e.g., anesthetics) and/or other materials contained within containers (e.g., vials) that are secured to the injection system can be selectively delivered into an anatomy through the needle. Nerve stimulation and/or imaging technologies (e.g., ultrasound) can be used to locate a targeted anatomical location. Aspiration can be used to confirm needle location. An overlay on the imaging display can include, in addition to real-time imaging data, data and other information relating to back pressure at or near the needle tip, volumes or other amounts of fluids delivered by and remaining within the system, stimulation level and/or the like.

Claims

1. An imaging-guided injection system for delivering an anesthetic to a target anatomical location of a patient, the system comprising:

a fluid delivery module comprising at least one loading area configured to receive a container comprising an anesthetic, the at least one loading area being configured to securely receive various sizes and shapes of the container;

at least one fluid reservoir within an interior of the fluid delivery module;

at least one fluid conduit configured to be placed in fluid communication with the at least one fluid reservoir, said at least one fluid conduit comprising a distal end, said distal end configured to receive a needle;

wherein the fluid delivery module is configured to selectively transfer at least a portion of the anesthetic from the container to the at least one fluid conduit via the at least one fluid reservoir;

wherein the fluid delivery module comprises at least one motor, said at least one motor being configured to facilitate the transfer of the anesthetic to the at least one fluid conduit;

at least one controller configured to regulate at least one aspect of the delivery of the anesthetic from the fluid delivery module to the target anatomical location of the patient according to a delivery scheme; and

wherein the system is configured to be placed in data communication with an imaging device to assist in accurately advancing the needle into the anatomy of the patient;

a display providing (i) status information related to the delivery of the anesthetic to the target anatomical location, and (ii) at least one real-time image obtained by an imaging device;

wherein the status information comprises at least one of;

(i) a volume of fluid delivered from the at least one fluid reservoir to the handpiece assembly, and (ii) a volume remaining in the at least one fluid reservoir of the fluid delivery module;

wherein the system is configured to be placed in data communication with an imaging device to assist in accurately advancing the stimulation needle into the anatomy of the patient;

wherein the display is additionally configured to provide at least one real-time image obtained by the imaging device; and

wherein the system is configured to detect a back-pressure associated with a delivery of the anesthetic through the at least one fluid conduit.

2. The injection system of claim 1, wherein the distal end of the at least one conduit is configured to receive a stimulation needle, said stimulation needle being configured to provide electrical stimulation to an anatomy of the patient.

3. The injection system of claim 1, wherein the imaging device comprises an ultrasound device.

4. The injection system of claim 1, wherein the at least one controller comprises a foot pedal assembly.

5. The injection system of claim 1, wherein the system is configured to aspirate a volume of native bodily fluid from the anatomy of the patient through the needle.

6. The injection system of claim 1, wherein the system is configured to detect a back-pressure associated with a delivery of the anesthetic through the at least one fluid conduit.

7. An imaging-guided injection system for delivering an anesthetic to a target anatomical location of a patient, the system comprising:

a fluid delivery module comprising at least one loading area configured to receive a container comprising an anesthetic, the at least one loading area being configured to securely receive various sizes and shapes of the container;

the fluid delivery module comprising at least one fluid reservoir;

at least one fluid conduit configured to be placed in fluid communication with the at least one fluid reservoir, said at least one fluid conduit comprising a distal end;

wherein the fluid delivery module is configured to selectively transfer at least a portion of the anesthetic from the container through the at least one fluid conduit via the at least one fluid reservoir;

wherein the distal end of the at least one fluid conduit is configured to removably receive a stimulation needle, said stimulation needle being configured to provide electrical stimulation to an anatomy of the patient;

wherein the fluid delivery module comprises at least one motor, said at least one motor being configured to facilitate the transfer of the fluid through the at least one fluid conduit and to the stimulation needle;

at least one controller configured to regulate at least one aspect of the delivery of the anesthetic from the fluid delivery module to the target anatomical location of the patient;

a display providing status information related to the delivery of the anesthetic to the target anatomical location, the display additionally providing at least one image obtained by an imaging device;

wherein the status information comprises at least one of;

(i) a volume of fluid delivered from the at least one fluid reservoir to the handpiece assembly, and (ii) a volume remaining in the at least one fluid reservoir;

wherein the system is configured to be placed in data communication with an imaging device to assist in accurately advancing the stimulation needle into the anatomy of the patient; and

wherein the system is configured to detect a back-pressure associated with a delivery of the anesthetic through the at least one fluid conduit.

8. The injection system of claim 7, wherein the distal end of the at least one fluid conduit is configured to removably receive a stimulation needle.

9. The injection system of claim 8, wherein the stimulation needle is configured to be in electrical communication with a nerve stimulator device via at least one lead, wherein the nerve stimulator device is operatively coupled to the fluid delivery module.

10. The injection system of claim 7, wherein the imaging device comprises an ultrasound device.

11. The injection system of claim 7, wherein the at least one controller comprises a foot pedal assembly.

12. The injection system of claim 11, wherein the foot pedal assembly comprises at least two independently controllable foot pedals, each of said foot pedals being configured to regulate a different aspect of the system.

13. The injection system of claim 7, wherein the system is configured to aspirate a volume of native bodily fluid from the anatomy of the patient through the stimulation needle.

14. The injection system of claim 13, wherein a volume of native bodily fluid from the anatomy of the patient is configured to be aspirated through the stimulation needle by applying a negative pressure to the at least one fluid conduit.

15. The injection system of claim 7, wherein the at least one loading area comprises a first loading area and at least a second loading area, wherein the first loading area is configured to receive a container containing the anesthetic, and wherein the second loading area is configured to receive a second container comprising a second fluid.

16. The injection system of claim 15, wherein the second fluid comprises at least one of an anesthetic and a non-anesthetic.

17. The injection system of claim 16, wherein the anesthetic comprises one or more of mepivacaine, ropivacaine, ropivacaine with epinephrine, mepivacaine with epinephrine and dextrose (D5W).

18. The injection system of claim 8, wherein the display is additionally configured to provide data relating to an electrical output provided to the stimulation needle.

19. The injection system of claim 7, wherein, during delivery of the anesthetic to the at least one fluid conduit, the display is additionally configured to provide data relating to a back pressure against which the anesthetic is being delivered.

20. The injection system of claim 7, wherein the system is configured to detect a back-pressure associated with a delivery of the anesthetic through the at least one fluid conduit.