Method of treating a joint using an articular injection system

• US 8,007,487 B2
• Filed: 12/22/2008
• Issued: 08/30/2011
• Est. Priority Date: 12/21/2007
• Status: Expired due to Fees

• Current Assignee: Carticept Medical, Inc.
• Original Assignee: Carticept Medical, Inc.
• Inventors: Ramey, Carribeth, Patrick, Timothy, Axelrod, Michael, Knostman, Richard
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Wilson; Larry R
• Application Number:
  US12/341,962
• Publication Number:
  US 20090171316A1
• Time in Patent Office: 981 Days
• Field of Search: 604 82- 83, 604/85, 604 87- 89, 604/131, 604/151, 604/152, 604/154, 604/155, 604257-259, 604/500, 604/506, 604/507, 604/511, 604518-520, 604/86
• US Class Current: 604/506
• 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 injecting at least two different medicaments contained in nonspecific fluid containers into a subcutaneous location of a patient using a single needle penetration, comprising:

providing an injection system comprising a fluid delivery module and a handpiece assembly;

wherein the fluid delivery module comprises a first loading area configured to receive a first container and a second loading area configured to receive a second container;

wherein the first container comprises a first medicament;

wherein the second container comprises a second medicament;

wherein the first loading area is configured to securely receive various sizes and shapes of the first container, and wherein the second loading area is configured to securely receive various sizes and shapes of the second container;

wherein the injection system is configured to receive instructions for delivering the first and second medicaments;

wherein the fluid delivery module is configured to transfer at least a portion of the first medicament from the first container to a first reservoir of the fluid delivery module;

wherein the fluid delivery module is configured to transfer at least a portion of the second medicament from the second container to a second reservoir of the fluid delivery module;

wherein the handpiece assembly is configured to receive a needle;

wherein said handpiece assembly is configured to selectively be in fluid communication with the first and second reservoirs of the fluid delivery module using tubing situated between the needle and the first and second reservoirs;

wherein said handpiece assembly is maneuverable to position the needle within the patient;

wherein the injection system (i) is configured to combine the first and second medicaments prior to delivery to the patient so that first and second medicaments are simultaneously delivered to the patient and (ii) is configured to administer the first and second medicaments sequentially, depending on the instructions entered by a user of the injection system;

delivering a volume of the first medicament from the fluid delivery module to the patient through the needle of the handpiece assembly based at least in part on instructions provided to the injection system; and

delivering a volume of the second medicament from the fluid delivery module to the patient through the needle of the handpiece assembly based at least in part on instructions provided to the injection system;

wherein a first plunger is slidably disposed within the first reservoir, and wherein a second plunger is slidably disposed within the second reservoir; and

wherein, based on the instructions, at least one motor of the fluid delivery module moves at least one of the first plunger and the second plunger within the corresponding reservoir to mechanically transfer at least one of the first medicament and the second medicament to the patient.

2. The method of claim 1, wherein the handpiece assembly comprises at least one controller, said at least one controller configured to receive instructions for delivery of at least one of the first medicament and the second medicament to the patient.

3. The method of claim 1, wherein the fluid delivery module is configured to transfer a predetermined volume of the first medicament and the second medicament to the patient.

4. The method of claim 1, wherein the first medicament comprises an anesthetic and wherein the second medicament comprises a steroid.

5. The method of claim 1, wherein the fluid delivery module further comprises a third loading area configured to receive a third container, said third container comprising a third medicament, wherein the injection system is configured to receive instructions for simultaneously or sequentially delivering the first, second and third medicaments through the handpiece assembly to a patient.

6. The method of claim 1, wherein the first and second medicaments are delivered simultaneously to a joint of the patient.

7. The method of claim 1, wherein the first and second medicaments are delivered sequentially to a joint of the patient.

8. The method of claim 1, wherein the fluid delivery module comprises a display configured to provide status information of an injection procedure.

9. The method of claim 8, wherein said status information comprises the volume of at least one of the first medicament and the second medicament delivered through the handpiece assembly or remaining in the first and second reservoirs of the fluid delivery module.

10. The method of claim 1, wherein the first container is an original manufacturer'"'"'s vial.

11. The method of claim 1, wherein the needle is secured to a removable tip of the handpiece assembly.

12. The method of claim 1, further comprising monitoring a position of a distal end of the needle using an imaging device to accurately locate a target anatomical location.

13. The method of claim 12, wherein the imaging device comprises an ultrasound device that is operatively connected to the injection system.

19. The method of claim 1, wherein the at least one motor is configured to move the first plunger independently of the second plunger.

14. A method of treating a joint of a patient by selectively delivering at least two different fluids through a single needle penetration to a subcutaneous location within an anatomy of the patient, comprising:

providing an injection system comprising a fluid delivery module and a handpiece assembly;

wherein the handpiece assembly comprises a disposable tip, a distal end of said tip comprising a needle;

wherein the handpiece assembly comprises at least one controller, said at least one controller configured to be operated while a user grasps said handpiece assembly;

wherein the fluid delivery module comprises a first loading area configured to receive a first container and a second loading area configured to receive a second container;

wherein the first container comprises a first fluid, and wherein the second container comprises a second fluid;

wherein the first fluid is configured to be selectively placed in fluid communication with a first reservoir of the fluid delivery module and a first conduit of the handpiece assembly after the first container is secured to the first loading area;

wherein the second fluid is configured to be selectively placed in fluid communication with a second reservoir of the fluid delivery module and a second conduit of the handpiece assembly after the second container is secured to the second loading area;

wherein the first and second conduits are routed through an interior of the handpiece assembly, said conduits placing the first and second reservoirs in fluid communication with the disposable tip;

wherein the first loading area and second loading area are configured to securely receive containers of various sizes and shapes;

wherein the injection system is configured to receive instructions for delivering the first and second fluids to the needle of the handpiece assembly;

wherein the fluid delivery module is configured to simultaneously transfer a volume of at least one of the first fluid and the second fluid to said needle through the first and second conduits under a first delivery protocol, and wherein the fluid delivery module is configured to sequentially transfer a volume of at least one of the first fluid and the second fluid to said needle through the first and second conduits under a second delivery protocol;

wherein said handpiece assembly is configured to be in data communication with the fluid delivery module;

wherein said handpiece assembly is maneuverable to position the needle within the patient;

wherein the first and second fluids are combined within the handpiece assembly at a location upstream of the needle under a simultaneous injection mode;

delivering a volume of the first fluid from the fluid delivery module to the patient through the needle and through the first conduit based at least in part on instructions provided to the at least one controller of the handpiece assembly; and

delivering a volume of the second fluid from the fluid delivery module to the patient through the needle and through the second conduit based at least in part on instructions provided to the at least one controller of the handpiece assembly;

wherein a first plunger is slidably disposed within the first reservoir, and wherein a second plunger is slidably disposed within the second reservoir;

wherein, based on the instructions, at least one motor of the fluid delivery module is configured to move at least one of the first plunger and the second plunger within the corresponding reservoir to mechanically transfer at least one of the first fluid and the second fluid through the handpiece assembly and to the patient; and

wherein the at least one motor is configured to move the first plunger independently of the second plunger.

15. The method of claim 14, wherein the at least one controller comprises at least one button.

16. The method of claim 14, wherein the first fluid comprises an anesthetic and wherein the second fluid comprises a steroid.

17. The method of claim 14, wherein each of said conduits comprises a valve to prevent backflow of said fluids toward the fluid delivery module.

18. The method of claim 14, further comprising monitoring a position of the needle using an imaging device to accurately locate a target joint of the patient.