Imaging-guided anesthetic injection method

• US 8,425,464 B2
• Filed: 06/11/2012
• Issued: 04/23/2013
• 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): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US13/493,960
• Publication Number:
  US 20120253182A1
• Time in Patent Office: 316 Days
• Field of Search: 604 80- 83, 604/85, 604/131, 604/152, 604/154, 604/155, 604257-259, 604/500, 604/506, 604/507, 604/511, 604518-520
• US Class Current: 604/154
• 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 8/0841 for locating instruments
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• 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 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• 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 5/20 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: G16H 20/17 delivered via infusion or injection

Abstract

Systems for injecting fluids and/or other materials into a targeted anatomical location, in particular, an intra-articular space, include a handpiece assembly having a proximal end and a distal end, a needle extending from the distal end of the handpiece assembly, a fluid delivery module comprising a cassette and a fluid transfer device. A conduit is generally configured to place the fluid delivery module in fluid communication with the handpiece assembly. Medications, formulations and/or other fluids or materials contained within vials that are secured to the fluid delivery module can be selectively delivered into an anatomy through a needle located at the distal end of the handpiece assembly. In some embodiments, ultrasound or other imaging technologies can be used to locate a joint or other targeted anatomical location.

Claims

1. A method of delivering an anesthetic to a subject using an imaging-guided injection system comprising:

securing a container containing an anesthetic to an injection system;

wherein the container is configured to be secured to a loading area of a fluid delivery module of the injection system, said loading area being configured to receive various sizes and shapes of the container;

wherein the fluid delivery module comprises at least one interior reservoir, wherein the at least one interior reservoir is configured to be placed in fluid communication with the container when said container is properly secured to the at least one loading area;

wherein at least one slidably movable member is configured to be moved within or out of the at least one interior reservoir to selectively transfer a volume of the anesthetic either into or out of the at least one interior reservoir, wherein movement of the at least one slidably movable member relative to the at least one interior reservoir changes an effective volume of the at least one interior reservoir;

wherein the at least one slidably movable member is configured to be moved using at least one motor;

wherein a volume of the anesthetic transferred out of the at least one interior reservoir is configured to be delivered to at least one conduit, said at least one conduit being configured to be placed in fluid communication with the at least one reservoir, said at least one conduit comprising a distal end;

securing a needle to the distal end of the at least one conduit;

transferring a volume of the anesthetic from the container into the at least one interior reservoir;

transferring a volume of the anesthetic out of the at least one interior reservoir and into the at least one conduit;

placing the needle within an anatomy of the subject for the subsequent delivery of the anesthetic through the at least one conduit and the needle;

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

wherein the injection system comprises a display configured to provide status information related to the delivery of the anesthetic to the target anatomical location; and

wherein the injection 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 subject.

2. The method of claim 1, wherein the display is configured to provide at least one real-time image obtained by the imaging device.

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

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

5. The method of claim 1, wherein the at least one controller comprises one or more buttons.

6. The method of claim 1, further comprising aspirating a volume of native bodily fluid from the anatomy of the subject at least partially through the needle.

7. The method of claim 6, further comprising aspirating a volume of native bodily fluid from the anatomy of the subject is configured to be aspirated through the needle by applying a negative pressure to the at least one conduit.

8. The method of claim 7, wherein the negative pressure within the at least one conduit is configured to be generated manually by the clinician.

9. The method of claim 7, wherein the negative pressure within the at least one conduit is configured to be is generated automatically using the fluid delivery module.

10. The method of claim 1, wherein the at least one loading area of the fluid delivery module comprises a first loading area and at least a second loading area, wherein the first loading area is configured to receive the container containing the anesthetic, and wherein the second loading area is configured to receive a second container comprising a second fluid, wherein the method further comprises selectively transferring said second fluid from the second container to the at least one conduit either sequentially or simultaneously with transferring the anesthetic to the at least one conduit.

11. The method of claim 10, wherein the second fluid comprises at least one of an anesthetic and a non-anesthetic.

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

13. The method of claim 1, wherein, during delivery of the anesthetic to the at least one conduit, the display is additionally configured to provide data relating to a back-pressure against which the anesthetic is being delivered.

14. The method of claim 1, wherein delivering the anesthetic of the target anatomical location of the subject comprises delivering the anesthetic to or near nerve tissue.

15. A method of delivering an anesthetic to a subject using an imaging-guided injection system comprising:

securing a container containing an anesthetic to an injection system;

wherein the container is configured to be secured to a loading area of a fluid delivery module of the injection system, said loading area being configured to receive various sizes and shapes of the container;

wherein the fluid delivery module comprises at least one interior reservoir, wherein the at least one interior reservoir is configured to be placed in fluid communication with the container when said container is properly secured to the at least one loading area;

wherein said at least one interior reservoir comprises at least one plunger, wherein movement of the at least one plunger within or out of the at least one interior reservoir changes an effective volume of the at least one interior reservoir;

wherein at least one motor is configured to selectively move the at least one plunger to mechanically transfer a volume of the anesthetic either into or out of the at least one interior reservoir, wherein a transfer of the volume of the anesthetic is performed mechanically;

wherein a volume of the anesthetic transferred out of the at least one interior reservoir is configured to be delivered to at least one conduit, said at least one conduit being configured to be placed in fluid communication with the at least one reservoir, said at least one conduit comprising a distal end;

securing a needle to the distal end of the at least one conduit;

transferring a volume of the anesthetic from the container into the at least one interior reservoir;

transferring a volume of the anesthetic out of the at least one interior reservoir and into the at least one conduit;

placing the needle within an anatomy of the subject for the subsequent delivery of the anesthetic through the at least one conduit and the needle;

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

wherein the injection system comprises a display configured to provide status information related to the delivery of the anesthetic to the target anatomical location;

wherein the injection 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 subject;

wherein the display is additionally configured to provide at least one real-time image of the anatomy of the subject 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 conduit.

16. The method of claim 15, wherein the imaging device comprises an ultrasound device.

17. The method of claim 15, wherein the at least one controller comprises a foot pedal assembly.

18. The method of claim 15, wherein the at least one controller comprises at least one of a button, a dial, a knob, a switch, a rollerball and a rollerwheel.

19. The method of claim 15, further comprising aspirating a volume of native bodily fluid from the anatomy of the subject at least partially through the needle.

20. The method of claim 19, further comprising aspirating a volume of native bodily fluid from the anatomy of the subject through the needle by applying a negative pressure to the at least one conduit.