Devices and Methods for Injection of Multiple-Component Therapies

• US 20080161772A1
• 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 8,057,426 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 method 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 mixture or reaction product that directly or indirectly results in some therapeutic, diagnostic or cosmetic benefit, said method comprising the steps of:

(A) providing a device which comprises i) a manifold having a first component substance flow channel and a second component substance flow channel, ii) a first injector connectable to the manifold and useable to inject a first component substance into the first component substance flow channel of the manifold, iii) a second injector connectable to the manifold and useable to inject a second component substance into the second component substance flow channel of the manifold and iv) an injector cannula assembly comprising a) 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

b) 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, 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.

(B) attaching injectors to the manifold;

(C) positioning the injector cannula at a desired location within or on the subject'"'"'s body; and

(D) using said injectors to inject component substances through the manifold and through the at least one injector cannula such that the resultant component substance mixture or reaction product is deposited at a desired location in or on the subject'"'"'s body.

2. A method according to claim 1 wherein the component substances become combined within the lumen of the outer tube such that the resultant component mixture or reaction product then flows out of the distal opening of the outer tube.

3. A method according to claim 1 wherein the component substances become combined after flowing out of the distal openings of the inner and outer tubes thereby causing the resultant component mixture or reaction product to be formed in or on the subject'"'"'s body.

4. A method according to claim 1 wherein the injector cannula has a tissue penetrating tip and wherein Step C comprises inserting the injector cannula through myocardial tissue to a location within the subject'"'"'s myocardium.

5. A method according to claim 4 wherein the injector cannula is inserted to a location within or near an area of impaired myocardial function and wherein Step D results in delivery of a component mixture or reaction product that has a therapeutic effect within said area of impaired myocardial function.

6. A method according to claim 5 wherein the first component substance comprises platelets and the second component substance comprises thrombin and wherein Step D results in the deposition of PG or APG at the desired location.

7. A method according to claim 1 wherein Steps C and D are repeated a number of times to cause quantities of the resultant component mixture or reaction product to be deposited at a plurality of locations within the subject'"'"'s body.

8. A method according to claim 5 wherein the subject has suffered from a myocardial infarction and wherein Steps C and D are carried out to deposit the resultant component mixture or reaction product at one or more locations within or near infarcted myocardium.

9. A method according to claim 1 wherein the device provided in Step A further comprises first and second fill reservoirs that contain quantities of the first and second component substances and are connected to the first and second injectors such that the first injector can be loaded with a quantity of the first component from the first fill reservoir and the second injector can be loaded with a quantity of the second component substance from the second fill reservoir while the first and second injectors remain attached to the manifold and wherein, after Step D has been performed, the method further comprises the steps of:

(E) loading the injectors with quantities of the component substances from the fill reservoirs; and

, thereafter

(F) repeating Step C and D.

10. A method according to claim 1 further comprising the step of controlling or maintaining the temperature of at least one component substance.

11. A method according to claim 10 wherein one of the component substances contains thrombin and wherein the step of controlling or maintaining the temperature of at least one component substance comprises cooling the thrombin-containing component substance to, or maintaining the thrombin-containing component substance at, a temperature that is below room temperature.

12. A method according to claim 1 further comprising the step of agitating at least one component substance.

13. A method according to claim 12 wherein the platelet-containing component comprises a suspension that contains platelets and wherein the method further comprises the step of agitating the platelet-containing component to maintain it as a substantially homogenous suspension.

14. A method for administering at least one substance into or onto the body of a human or animal subject, said method comprising the steps of:

(A) providing a device which comprises i) at least one injector having a barrel into which a substance may be loaded, an outlet opening and a plunger that may be depressed to cause a substance that has been loaded into the barrel to be expelled out of the outlet opening, ii) a first set of finger grips at a first location and iii) a second set of finger grips at a second location;

(B) loading a substance into the barrel;

(C) selecting either the first set of finger grips or the second set of finger grips;

(D) placing fingers of one hand under the finger grips selected in Step B;

(E) placing the thumb of the same hand in a position to depress the plunger; and

(F) using the thumb to depress the plunger thereby expelling at least some of the substance from the barrel and out of the outlet opening.

15. A method according to claim 14 wherein the first set of finger grips is located a first distance from the location at which the thumb is positioned in Step E and the second set of finger grips is located a second distance from the location at which the thumb is positioned in Step E and wherein the selection of a set of finger grips in Step C is based on which of said first and second distances is best suited to the size of the user'"'"'s hand.

16. A method according to claim 14 wherein the device provided in Step A comprises a first injector having a barrel into which a first substance may be loaded, a first outlet opening and a first plunger that may be depressed to cause the first substance to be expelled out of the first outlet opening, a second injector having a barrel into which a second substance may be loaded, a second outlet opening and a second plunger that may be depressed to cause the second substance to be expelled out of the second outlet opening and a depressible member that engages the first and second plungers and may be used to simultaneously depress the first and second plungers, and wherein;

Step B comprises loading a first substance into the first barrel and loading a second substance into the second barrel;

Step D comprises placing the thumb of the same hand on the depressible member; and

Step F comprises using the thumb to depress the depressible member, thereby depressing the first and second plungers and expelling the first and second substances from the first and second barrels and out of the first and second outlet openings.

17. A method according to claim 16 wherein the device provided in Step A further comprises at least one cannula and the 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, wherein the method further comprises the additional step of:

positioning said at least one cannula on or in the body of the subject; and

wherein the performance of Step F causes the first and second substances to become combined.

18. A method according to claim 17 wherein the first cannula lumen and the second cannula lumen are in biaxial relation to one another.

19. A method according to claim 16 wherein the device provided in Step A further comprises a cannula assembly that has a tissue penetrating tip and wherein the step of positioning said at least one cannula on or in the body of the subject comprises inserting the tissue penetrating tip of the cannula assembly into tissue.

20. A method according to claim 16 wherein the device provided in Step A further comprises a cannula assembly that includes i) 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 ii) 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, wherein the method further comprises the additional step of:

positioning said at least one cannula on or in the body of the subject; and

wherein during performance of Step F, the second substance becomes combined with the first substance thereby forming a resultant substance mixture or reaction product.

21. A method according to claim 20 wherein the device provided in Step A further comprises a cannula assembly that has a tissue penetrating tip and wherein the step of positioning said at least one cannula on or in the body of the subject comprises inserting the tissue penetrating tip of the cannula assembly into tissue.

22. A method according to claim 16 wherein the method is a number of times to cause quantities of the resultant component mixture or reaction product to be deposited at a plurality of locations.

23. A method according to claim 16 wherein the device provided in Step A further comprises first and second fill reservoirs that contain quantities of the first and second substances and are connected to the first and second injectors such that the first injector can be loaded with a quantity of the first substance from the first fill reservoir and the second injector can be loaded with a quantity of the second substance from the second fill reservoir and wherein the method further comprises the step of loading the first and second injectors with quantities of the first and second substances from the first and second fill reservoirs.

24. A method according to claim 14 further comprising the step of controlling or maintaining the temperature of a substance.

25. A method according to claim 24 wherein the device provided in Step A includes at least one fill reservoir which contains a component substance and from which that component substance is loadable into an injector and wherein the step of controlling or maintaining the temperature of at least one component substance comprises controlling or maintaining the temperature of that component substance while it is in the at least one fill reservoir.

26. A method according to claim 14 further comprising the step of agitating a substance.

27. A method according to claim 14 wherein the device provided in Step A includes at least one fill reservoir which contains a substance and from which that substance is loadable into an injector and wherein the step of agitating at least one substance comprises agitating that substance while it is in the at least one fill reservoir.