Devices and Methods for Injection of Multiple-Component Therapies

• US 20080161757A1
• Filed: 01/03/2008
• Published: 07/03/2008
• Est. Priority Date: 01/03/2007
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Nayak, Asha, Maciel, Mario
• Granted Patent: US 7,699,803 B2
• Time in Patent Office: Days
• US Class Current: 604/82
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3201 Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/3626 by controlled mixing of fluids at different temperatures
• CPC Class Codes: A61M 2205/3633 thermally insulated
• CPC Class Codes: A61M 2205/3646 by heat accumulators, e.g. ice, sand
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• 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 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3137 Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3294 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3295 Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61M 5/445 the media being heated in the reservoir, e.g. warming bloodbags
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

Devices and methods for injecting or otherwise delivering multiple-component therapies to human or animal subjects. Devices having injectors (e.g., syringes) attached to biaxial or coaxial injection cannula(s) are used to deliver multiple components of a particular therapy such that those components become combined shortly before or upon exiting the injection cannula(s). In some embodiments, the injector devices of the present invention may include a first set of finger grips at a first location and a second set of finger grips at a second location. Also, in some embodiments, the injector devices of the present invention may include depth slops for controlling the depth within tissue at which the therapeutic substance is delivered. Also, in some embodiments, the injector devices of the present invention may include refill manifolds with attached syringes or other reservoirs containing the component substances to facilitate refilling of the injectors.

Claims

1. A device for administering a plurality of component substances into or onto the body of a human or animal subject such that the component substances become combined to produce a resultant component mixture or reaction product that directly or indirectly results in some therapeutic, diagnostic or cosmetic benefit, said device comprising:

a manifold having a first component substance flow channel and a second component substance flow channel;

a first injector connectable to the manifold and usable to inject a first component substance into the first component substance flow channel of the manifold;

a second injector connectable to the manifold and usable to inject a second component substance into the second component substance flow channel of the manifold;

an injector cannula assembly comprising;

an outer tube that has an outer tube lumen and a distal opening, said outer tube being connected to the first component substance flow channel of the manifold such that the first component substance will flow through the outer tube lumen; and

an inner tube that has an inner tube lumen and a distal opening, said inner tube being connected to the second component substance flow channel of the manifold such that the second component substance will flow therefrom into the inner tube lumen and out of the distal opening of the inner tube; and

wherein at least a portion of the inner tube extends through at least a portion of the outer tube lumen such that the second component substance becomes combined with the first component substance thereby forming a resultant component substance mixture or reaction product.

2. A device according to claim 1 wherein the distal opening of the inner tube is located within the outer tube lumen such that the first and second component substances become combined within the outer tube lumen.

3. A device according to claim 1 wherein the distal end opening of the inner tube is located flush with or outside of the distal opening of the outer tube such that the first and second component substances become combined after exiting the distal openings of the inner and outer tubes.

4. A device according to claim 1 wherein a portion of the inner tube is substantially coaxially disposed within the outer tube lumen.

5. A device according to claim 1 further comprising a handle that facilitates holding of the device by a human operator, the handle being configured to hold the first and second injectors;

and

the handle further comprises a depressible member that, when depressed, causes substantially simultaneous injection of the first and second component substances from the first and second injectors.

6. A device according to claim 5 wherein the handle further comprises finger grips for receiving the operator'"'"'s fingers while the operator'"'"'s thumb is used to depress the depressible member and the handle is configured such that an operator can use the device with a one hand.

7. A system according to claim 5 wherein the first and second injectors have plungers which may be depressed to cause injection of the first and second component substances and wherein the depressible member engages the plungers of the first and second injectors and is usable to simultaneously depress those plungers at substantially the same rate.

8. A system according to claim 1 wherein the first injector and second injector differ in size.

9. A system according to claim 8 wherein the ratio of the volumes of the first injector and the second injector is approximately ten to one.

10. A device according to claim 1 further comprising:

a first fill reservoir for containment of a quantity of the first component substance and a second fill reservoir for containment of a quantity of the second component substance;

the first fill reservoir being connected to the first injector and the second fill reservoir being connected to the second injector such that the first injector may be loaded with a quantity of the first component substance from the first fill reservoir and the second injector may be loaded with a quantity of the second component substance from the second fill reservoir, without requiring detachment of the first or second injectors from the manifold.

11. A device according to claim 10 further comprising first and second valves, each of said first and second valves being movable between i) a first position whereby it allows a quantity of a component substance to flow from a fill reservoir into an injector and ii) a second position whereby the component substance may be injected from that injector through the manifold and through the injector cannula without backflowing into the fill reservoir.

12. A device according to claim 1 further comprising apparatus for controlling or maintaining the temperature of at least one component substance.

13. A device according to claim 12 wherein the device includes at least one fill reservoir from which a component substance flows into a component injector and wherein the apparatus for controlling or maintaining the temperature of at least one component substance operates to control or maintain the temperature of a component substance while it is contained in the at least one fill reservoir.

14. A device according to claim 1 further comprising apparatus for agitating at least one component substance.

15. A device according to claim 14 wherein the device includes at least one fill reservoir from which a component substance flows into a component injector and wherein the apparatus for agitating at least one component substance operates to agitate a component substance while contained in the at least one fill reservoir.

16. A device according to claim 1 wherein the injector cannula has a sharp tissue-penetrating distal end.

17. A device according to claim 1 further comprising a depth stop for limiting the depth to which the injector cannula may be advanced into tissue.

18. An injector device comprising:

At least one injector having a barrel into which a flowable substance may be loaded, an outlet opening and a plunger that may be depressed by the thumb of a user to cause a substance that has been loaded into the barrel to be expelled out of the outlet opening;

a first set of finger grips at a first location; and

a second set of finger grips at a second location.

19. An injector device according to claim 18 wherein said at least one injector comprises:

a first injector having a barrel into which a first substance may be loaded, a first outlet opening and a first plunger that, when depressed, causes a first substance that has been loaded into the barrel of the first injector to be expelled out of the outlet opening of the first injector;

a second injector having a barrel into which a second substance may be loaded, a second outlet opening and a second plunger that, when depressed, causes a second substance that has been loaded into the barrel of the second injector to be expelled out of the outlet opening of the second injector;

a thumb-depressible member that engages both the first and second plungers so as to depress both the first and second plungers at substantially the same rate;

a manifold connected to the first and second injectors, said manifold having a first substance flow channel into which the first substance flows from the first injector and a second substance flow channel into which the second substance flows from the second injector; and

at least one cannula attached to the manifold.

20. A device according to claim 19 wherein said at least one cannula comprises a first cannula lumen through which the first substance flows and a second cannula lumen through which the second substance flows, and the first cannula lumen and the second cannula lumen are in biaxial relation to one another.

21. A device according to claim 19 wherein said at least one cannula comprises a cannula assembly that includes;

an outer tube that has an outer tube lumen and a distal opening, said outer tube being connected to the first substance flow channel of the manifold such that the first substance will flow through the outer tube lumen; and

an inner tube that has an inner tube lumen and a distal opening, said inner tube being connected to the second substance flow channel of the manifold such that the second substance will flow therefrom into the inner tube lumen and out of the distal opening of the inner tube; and

wherein at least a portion of the inner tube extends through at least a portion of the outer tube lumen such that the second substance becomes combined with the first substance thereby forming a resultant substance mixture or reaction product.

22. A device according to claim 21 wherein a portion of the inner tube is substantially coaxially disposed within the outer tube lumen.

23. A device according to claim 18 wherein said at least one injector comprises a syringe.

24. A device according to claim 19 further comprising:

a first fill reservoir for containment of a quantity of the first substance and a second fill reservoir for containment of a quantity of the second substance, the first fill reservoir being connected to the first injector and the second fill reservoir being connected to the second injector such that the first injector may be loaded with a quantity of the first substance from the first fill reservoir and the second injector may be loaded with a quantity of the second substance from the second fill reservoir, without requiring detachment of the first or second injectors from the manifold; and

a first valve and a second valve, each of said first and second valves being movable between i) a first position whereby it allows a quantity of a substance to flow from a fill reservoir into an injector and ii) a second position whereby the substance may be injected from that injector without backflowing into the fill reservoir.

25. A device according to claim 24 wherein the first and second fill reservoirs comprise syringes.

26. A device according to claim 24 further comprising apparatus for controlling or maintaining the temperature of at least one of the substances while the at least one substance is contained in at least one of the first fill reservoir or the second fill reservoir.

27. A device according to claim 24 further comprising apparatus for agitating at least one of the substances while the at least one substance is contained in at least one of the first fill reservoir or the second fill reservoir.

28. A device according to claim 19 wherein said at least one cannula has a sharp tissue-penetrating distal end and a depth stop for limiting the depth to which the cannula may be advanced into tissue.