Devices and methods for injection of multiple-component therapies
First Claim
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) preparing a device which comprisesi) a manifold having a first component substance flow channel and a second component substance flow channel;
ii) a first assembled injector comprising a barrel and a moveable plunger positioned within the barrel, said first assembled injector being 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 assembled injector comprising a barrel and a movable plunger positioned within the barrel, said second assembled injector being 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;
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; and
v) 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 assembled with their moveable plungers positioned within their barrels and attached to the manifold;
(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;
(E) reloading the assembled injectors with quantities of the component substances from the fill reservoirs without disassembly of the injectors or removal of their plungers from their barrels; and
, thereafter(F) repeating Step C and D.
1 Assignment
0 Petitions
Accused Products
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.
27 Citations
22 Claims
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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:
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(A) preparing a device which comprises i) a manifold having a first component substance flow channel and a second component substance flow channel; ii) a first assembled injector comprising a barrel and a moveable plunger positioned within the barrel, said first assembled injector being 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 assembled injector comprising a barrel and a movable plunger positioned within the barrel, said second assembled injector being 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;
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; andv) 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 assembled with their moveable plungers positioned within their barrels and attached to the manifold; (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; (E) reloading the assembled injectors with quantities of the component substances from the fill reservoirs without disassembly of the injectors or removal of their plungers from their barrels; and
, thereafter(F) repeating Step C and D. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for injecting a therapeutic substance formed by combining a plurality of component substances, into a beating heart of a human or animal subject, said method comprising the steps of:
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(A) preparing a device which comprises i) first and second injectors, each injector having a barrel into which a component substance may be loaded, an outlet opening and a plunger that may be depressed to cause the component substance that has been loaded into the barrel of that injector 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 distal to the first location, a tissue penetrating needle having a sharp tissue-penetrating tip with a distal opening and a lumen, the lumen of the needle being connected to the outlet openings of the injectors such that the component substances, when expelled from the first and second injectors, become combined within the lumen of the needle to form said therapeutic substance which then flows out of the needle'"'"'s distal opening; (B) loading a first component substance into the barrel of the first injector and loading a second component substance into the barrel of the second injector; (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 concurrently depress the plungers of the first and second injectors; and (F) inserting the sharp tissue-penetrating tip of the needle into the myocardium of the beating heart and using the thumb to concurrently depress the plungers thereby causing at least some of the first and second component substances to be expelled through the outlet openings of the injectors resulting in their combination within the needle lumen to form the therapeutic substance and flow of the therapeutic substance out of the distal opening of the needle into the myocardium. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification