Medicinal implant and device and method for loading and delivering implants containing drugs and cells

Information

  • Patent Grant
  • 6648849
  • Patent Number
    6,648,849
  • Date Filed
    Wednesday, June 27, 2001
    23 years ago
  • Date Issued
    Tuesday, November 18, 2003
    21 years ago
Abstract
A system for injecting controlled release medicinal implants has a syringe-like injector body with a lumen and plunger. A needle is attached to the injector body and receives therein an injectable implant with an internal hollow. The implant is retained in the needle by friction, which is overcome by the plunger upon dispensing. As the plunger moves from the retracted position to the deployed position, it forces a medicament previously loaded into the injector body into the implant hollow and then pushes the implant out of the needle into the creature into which the needle has been inserted. The implant may contain a filler to absorb flowable medicaments to aid in their retention within the implant. As in known implants, the medicament is released gradually depending upon the dissolution rate of the implant body which is formed from a biodegradable material. Because the medicament is loaded into the implant at the time of injection, issues concerning the reaction of the medicament with the implant material during preparation and storage are eliminated.
Description




FIELD OF THE INVENTION




The present invention relates to a device for inserting or implanting a solid or semi-solid drug or cell delivery implant subcutaneously, interstitially or intramuscularly. More particularly, the invention relates to a device for loading a solution, suspension, a flowable phase or a solid into a delivery implant at the time of use followed by implantation of the implant under the surface of the skin or within the muscle of a human or animal.




BACKGROUND OF THE INVENTION




Implantation of medical devices is a widely accepted medical procedure to deliver medicaments, such as pharmaceutical agents and bioactive compounds, for treatment of disease in humans and other species. Many types of medicaments have been delivered as implants, including hormones for reproductive control, vaccines, and antibiotics. In more recent technologies, the implantable composition has contained the medicament in a biologically compatible adsorbing polymer matrix. However, these compositions are prepared prior to use and suffer from the inherent problems presented by processing a polymer with a medicament. These difficulties include the use of complex processing techniques to avoid degrading the active agent in the medicament and concerns about the shelf-life of the polymer/medicament composition after processing and compatibility/reactivity between the medicament and the polymer. For example, an aqueous based medicament will degrade a biodegradeable polymer implant.




While the prior art is replete with various medicament implants, e.g., in pelletized form, as well as, various apparatus for loading and introducing such implants into the body of a living creature, it does not adequately address the above stated concerns by providing a simple medicinal implant loading and injecting mechanism that maximally preserves the medicament from degradation during the processing/formation of the implant, (which may, e.g., involve high temperatures, such as during injection molding, exposure to radiation during curing and/or sterilization) nor from degradation due to chemical reaction with the material of the implant during processing and/or storage prior to use.




SUMMARY OF THE INVENTION




The problems and disadvantages associated with the conventional techniques and devices utilized to prepare and inject medicinal implants are overcome by the present invention which includes a system for implanting medicinal implants into the body of a living creature. The system has an injector body with a first lumen therein and a plunger slideable within the first lumen between a retracted position and a deployed position. A needle having a second lumen therein is coupled to the injector body with the second lumen communicating with the first lumen. An injectable implant having an internal hollow is positionable within at least one of the first and second lumens with the hollow communicating with the first lumen. A medicament is at least partially storable within the first lumen when the plunger is in the retracted position. The internal hollow of the injectable implant receives at least a portion of the medicament when the plunger is moved from the retracted position to the deployed position. The plunger pushes the injectable implant through the second lumen and out of the needle when the plunger assumes the deployed position.











BRIEF DESCRIPTION OF THE FIGURES





FIG. 1

is a perspective view of a device for introducing medicinal implants into the body of a human or an animal in accordance with an exemplary embodiment of the current invention;





FIG. 2

is a cross-sectional view of a portion of the device of

FIG. 1

prior to loading an active agent into a delivery implant held in a needle portion thereof;





FIG. 3

is a cross-sectional view of the device of

FIGS. 1

at an intermediate stage during the loading of active agent into the delivery implant;





FIG. 4

is an enlarged view of a segment of the device shown in

FIG. 3

; and





FIG. 5

is a cross-sectional schematic view of the device of

FIGS. 1-4

as the delivery implant is being administered under the skin of a living subject.











DETAILED DESCRIPTION OF THE INVENTION




The present invention provides an insertion device that loads a precise and accurate amount of an active agent into a hollow delivery implant at the time of subcutaneous or intramuscular insertion. By loading the delivery implant at the time of insertion, reaction between the medicament and the implant during implant manufacture and storage is avoided.




An embodiment of the present invention is shown in

FIGS. 1

to


5


.

FIG. 1

is a perspective view of an implant insertion device


10


, having barrel


20


, needle


22


, and plunger


30


. Both barrel


20


and needle


22


are cannulated to allow passage of plunger


30


coaxially therethrough. On the distal, or front, end of barrel


20


is hub


24


and cap


28


. Both hub


24


and cap


28


have bores therein to allow passage of needle


22


and plunger


30


therethrough.




Hub


24


may be attached to barrel


20


by one of several common means. For example, hub


24


may have a female thread on the interior surface of its proximal, or rear, end that is matched to a male thread on the exterior distal surface of barrel


20


. Hub


24


may also be glued (epoxied) or press fit onto barrel


20


.




Cap


28


is attached to the distal end of hub


24


. Cap


28


may be attached to hub


24


by one of several common means. For example, cap


28


may have a female thread on the interior surface of its proximal end, which is matched to a male thread on the exterior distal surface of hub


24


.




In the alternative, the needle


22


can be attached to the barrel


20


via a Luer-type fitting, a fitting which is well known in the art. (LUER-LOK) is a registered trademark of Becton, Dickinson and Company, of Franklin Lakes, N.J. More specifically, one of the mating ends of the Luer-type fitting can be machined, molded or epoxied onto the proximal end of needle


22


. The mating Leur-type fitting can be machined, molded or epoxied onto the end of the barrel


20


, replacing hub


24


. As yet another alternative, the entire barrel


20


and hub


24


can be molded as one piece, eliminating the need for attachment of a separate hub.




Plunger


30


extends from the proximal end of barrel


20


and partially through the cannulation (lumen)


21


(See

FIG. 4

) of barrel


20


. Plunger


30


is provided at its proximal end with flange


38


to receive manual pressure. Flange


38


may be attached to plunger


30


by one of several common means. For example, flange


38


may have a blind hole with a female thread that is matched to a male thread on the proximal end of plunger


30


. Flange


38


may also be press fit, soldered, or epoxied onto plunger


30


. The plunger tip


23


(See

FIG. 4

) may have a plastic piston on it to better seal against the cannulation


21


of barrel


20


. In addition, the distal end of plunger


30


may be beveled or rounded to ensure a smooth transition from the cannulation


21


of barrel


20


to the cannulation (lumen)


25


(See

FIG. 4

) of needle


22


.




Suitable materials from which the barrel


20


, needle


22


, hub


24


, cap


28


, plunger


30


, and flange


38


members may be formed include glasses, noncorrodible metals, noncorrodible synthetic resins such as plastics, and the like. These materials may be used alone or in combination. If the members are of glasses, noncorrodible metals, or sterilizable noncorrodible synthetic resins, they may be used repeatedly by performing sterilization. Preferably, barrel


20


is formed from glass or plastic, needle


22


and plunger


30


are formed from noncorrodible metals, and hub


24


, cap


28


, and flange


38


members are formed from plastic or metals.





FIGS. 2-5

are cross-sectional views of the distal portion of implant insertion device


10


.

FIG. 2

shows the distal portion of plunger


30


located in the cannulation


21


(See

FIG. 4

) of barrel


20


. In the distal portion of the cannulation


21


of barrel


20


is located the active agent


44


to be loaded into hollow delivery implant


40


by the means discussed herein. The cross-sectional dimensions, e.g., the diameter, of the cannulation


21


of barrel


20


is matched to that of plunger


30


so that the plunger


30


may push the active agent


44


through the cannulation


21


of barrel


20


without the active agent


44


leaking between the plunger


30


and the barrel


20


. This is particularly applicable to active agents


44


in liquid, gel or paste forms. The cross-sectional shape of the plunger


30


and cannulation


21


of barrel


20


may be hexagonal, octagonal, eliptical or any other shape, with a circular cross-sectional shape being preferred.




Needle


22


is located at the distal end of barrel


20


, and passes through both hub


24


and cap


28


. Delivery implant


40


is located in the proximal portion of the cannulation


25


of needle


20


. The diameter of the cannulation


25


of needle


22


is matched to that of plunger


30


such that the plunger


30


may push the active agent


44


through the cannulation


25


without the active agent


44


leaking between the plunger


30


and the needle


22


. The outer diameter of delivery implant


40


is matched to the diameter of the cannulation


25


of needle


22


to form a friction fit such that delivery implant


40


does not inadvertently slide out of the cannulation


25


of needle


22


prior to being purposely forced out by plunger


30


and to insure that the active agent does not leak between delivery implant


40


and the cannulation


25


. The delivery implant


40


has a hollow bore


27


with an inner diameter that is sufficiently less than the diameter of the plunger


30


, such that the plunger


30


bears upon the delivery implant


40


and does not enter the hollow bore


27


of the delivery implant


40


while the implant


40


is being forced out of the cannulation


25


of needle


22


.




Collar


34


and gasket


32


are located on the proximal end of needle


22


. Both are cannulated to allow coaxial placement over the needle


22


. The collar


34


is press fit over the outer diameter of needle


22


. The outer diameter of needle


22


is also closely matched to the diameter of the cannulation of gasket


32


such that the gasket


32


presses forcefully against the needle


22


to establish a seal, as well as to strengthen the mechanical retention of the needle


22


when the cap


28


is tightened on to the hub


24


.




Suitable materials from which the collar


34


may be formed include glasses, noncorrodible metals, noncorrodible synthetic resins such as plastics, soft metal, and the like. These materials may be used alone or in combination. If collar


34


is of glass, noncorrodible metal, or sterilizable noncorrodible synthetic resin, it may be used repeatedly by performing sterilization. The collar


34


may also be disposed of as expendable after one use.




Suitable materials from which the gasket


32


may be formed include those such as, for example, noncorrodible synthetic resins such as plastics, and the like. Synthetic resins are used because gasket


32


needs to deform when attaching needle


22


to barrel


20


. If gasket


32


is of sterilizable noncorrodible synthetic resin, it may be used repeatedly by performing sterilization. The gasket


32


may also be disposed of as expendable after one use.




Preferably, collar


34


is formed from noncorrodible metal, such as


304


or


316


stainless steel, and gasket


32


is formed from a noncorrodible synthetic resin such as poly(tetrafluoro ethylene), sold under the tradename TEFLON by E.I. duPont (Wilmington, Del.).




To attach needle


22


to barrel


20


, the proximal end of the needle


22


, gasket


32


, and collar


34


assembly is first placed in the hub cannula


29


. Next, the distal end of needle


22


is passed through the through hole of cap


28


until cap


28


comes into contact with the distal end of collar


34


. Then, cap


28


is attached to the distal end of hub


24


by means such as those discussed above.





FIGS. 3 and 4

show the loading of active agent


44


into delivery implant


40


. Plunger


30


is urged through the cannulation


21


of barrel


20


by application of a force on flange


38


(See FIG.


1


). Active agent


44


is driven into the proximal end of delivery implant


40


hollow


27


by plunger


30


. Delivery implant


40


in this embodiment is a tubular structure that is open at both distal (input) and proximal (vent) ends. This configuration permits active agent


44


to pass from the cannulation


21


of barrel


20


into the hollow


27


of delivery implant


40


. Any gas trapped within the hollow


27


may be vented from the proximal end. The active agent


44


may be of a variety of compositions and may be a solid, liquid, gel, paste, suspension or combination of the foregoing. In

FIGS. 1-5

, the active agent


44


is depicted in the form of a solid, slender rod. A solid active agent


44


was selected to facilitate the illustration of the invention, but as noted, the active agent


44


can exhibit any selected phase. The volume of active agent


44


in the cannulation


21


of barrel


20


may be more than, less than, or equal to the volume of the hollow


27


of the delivery implant


40


. Preferably, the volume of active agent


44


in the cannulation


21


of barrel


20


is matched to the volume of the hollow


27


so that active agent


44


fills the hollow


27


when the distal end of plunger


30


reaches the distal end of the cannulation


21


of barrel


20


.





FIG. 5

shows delivery implant


40


, loaded with active agent


44


, being administered under the skin


50


of a patient. Plunger


30


is forced into the cannulation


25


of needle


22


by application of a force on flange


38


. Delivery implant


40


, loaded with active agent


44


, is forced out of the distal end of needle


22


by plunger


30


. Delivery implant


40


is fully administered when the distal end of plunger


30


reaches the distal end of needle


22


.




While it is possible to begin displacement of the active agent


44


into the delivery implant


40


prior to the needle


22


penetrating the skin


50


, it is preferred that the needle


22


of implant insertion device


10


penetrates the skin


50


of the patient prior to the loading of active agent


44


into delivery implant


40


. That is, prior to plunger


30


being forced into the cannulation


21


of barrel


20


by application of a force on flange


38


.




In this manner, the implant insertion device


10


of this invention allows for a simple, one-step process for loading the delivery implant


40


with active agent


44


at the time the implant is being inserted into the patient. After inserting the needle


22


into the patent, the health professional administering the delivery implant forces the plunger


30


into the barrel


20


. In one step, the active agent


44


is loaded into the delivery implant


40


, and the implant


40


is administered to the patient. By loading the delivery implant


40


at the time of insertion, issues of processing and shelf-life of preloaded delivery implants are avoided.




In accordance with one method of loading the implant insertion device


10


prior to use, the hub


24


is first attached to the barrel


20


by means described above. The plunger


30


is inserted into the cannulation


21


of the barrel


20


until the distal end of the plunger


30


reaches the distal end of the barrel


20


. The cannulation


21


of the barrel


20


is filled with the appropriate amount of active agent


44


by moving the plunger


30


proximally, which, in the case of a flowable active agent


44


, such as a liquid or gel, will draw the active agent


44


into the cannulation


21


of barrel


20


as the plunger


30


retreats in a proximal direction.




In accordance with another method, the plunger


30


is partially inserted into the cannulation


21


of the barrel


20


, and the active agent


44


metered into the cannulation


21


through the distal end, of the barrel


20


, e.g., through the hub cannula


29


. If the active agent


44


is flowable, then the hub cannula


29


may be plugged with rubber or resin to eliminate evaporation or leakage during storage. Prior to injection of the implant, the hub cannula


29


plug


33


(shown diagrammatically in

FIG. 4

by dotted lines) may be removed or pierced. The hub cannula


29


plug or seal


33


may be in the form of a rupturable membrane that ruptures under the pressure exerted on the plunger


30


by the user of the device


10


.




In separate process steps, the needle


22


portion of the implant insertion device


10


may be prepared for assembly to the hub


24


as follows. The needle


22


with press fit collar


34


is passed through the bore in the cap


28


and the gasket


32


is placed on the needle


22


abutting the collar


34


. The delivery implant


40


is then inserted into the cannulation


25


of the needle


22


, thus completing preparation for the assembly of needle portion


22


to the hub


24


.




If the active agent


44


is sealed in cannulation


21


of barrel


20


by a plug


33


or membrane occluding hub cannulation


29


,, then the barrel


20


and needle


22


of the implant insertion device


10


may be assembled prior to packaging and sterilization. Alternatively, the active agent


44


may be stored separately from the device


10


and introduced into the device


10


, i.e., by the methods outlined above, just prior to injection of the delivery implant


40


.




If different means of sterilization are required for the delivery implant


40


, the device


10


and the active agent, then it is preferred that each of these components be packaged and sterilized separately. In this manner, degradation of the active agent


44


due to exposure to, e.g., radiation used to sterilize the device


10


, can be avoided. The separate portions of the device may then be assembled as described above at the time of use by the medical professional.




As mentioned earlier, if a prior art delivery implant is made from a biodegradable polymer, there are inherent problems presented by combining the biodegradable polymer with a medicament containing an active agent. These include having to use complex processing techniques so as not to harm the active agent, being concerned with the shelf-life of the polymer/active agent composition after processing and compatibility issues between the active agent and the polymer such as if the medicament is aqueous based, and the polymer degrades when exposed to water. In accordance with the present invention, by loading the delivery implant at the time of insertion, issues of undesirable processing and shelf-life reactions are avoided.




A variety of biodegradable polymers can be used to make the delivery implant


40


of the present invention. Examples of suitable biocompatible, biodegradable polymers include polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biomolecules (i.e., biopolymers such as collagen, elastin, bioabsorbable starches, etc.) and blends thereof. For the purpose of this invention aliphatic polyesters include, but are not limited to, homopolymers and copolymers of lactide (which includes lactic acid, D-,L- and meso lactide), glycolide (including glycolic acid), ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ-valerolactone, β-butyrolactone, ε-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one 2,5-diketomorpholine, pivalolactone, γ-diethylpropiolactone, ethylene carbonate, ethylene oxalate, 3-methyl-1,4-dioxane-2,5-dione, 3,3-diethyl-1,4-dioxan-2,5-dione, 6,8-dioxabicycloctane-7-one and polymer blends thereof.




The active agent


44


used in the implant insertion device


10


of the present invention may be of a pharmacological and/or cellular nature. The variety of different pharmacological agents that can be used in conjunction with the present invention is vast. In general, pharmacological agents which may be administered via this invention include, without limitation: antiinfectives such as antibiotics and antiviral agents; chemotherapeutic agents (i.e. anticancer agents); anti-rejection agents; analgesics and analgesic combinations; anti-inflammatory agents; hormones such as steroids; antigens, including but not limited to cytokines, attachment factors, genes, peptides, proteins, nucleotides, carbohydrates or even cells or cell fragments; growth factors, including bone morphogenic proteins (i.e. BMP's 1-7), bone morphogenic-like proteins (i.e. GFD-5, GFD-7 and GFD-8), epidermal growth factor (EGF), fibroblast growth factor (i.e. FGF 1-9), platelet derived growth factor (PDGF), insulin like growth factor (IGF-I and IGF-II), transforming growth factors (i.e. TGF-βI-III), vascular endothelial growth factor (VEGF); and other naturally derived or genetically engineered proteins, polysaccharides, glycoproteins, or lipoproteins.




The pharmacological agent may be present as a liquid, or formulated in a solution, suspension, or gel containing the component(s), or any other appropriate physical form. Typically, but optionally, additives, such as diluents, carriers, excipients, stabilizers or the like may be included in the formulation.




The amount of pharmacological agent will depend on the particular medical condition being treated, and will vary depending on the release profile desired and the amount of drug employed. Prolonged delivery (over, say 1 to 5,000 hours, preferably 2 to 800 hours) of effective amounts (say, 0.0001 mg/kg/hour to 10 mg/kg/hour) of the agent are desired. This dosage form can be administered as is necessary depending on the subject being treated, the severity of the affliction, the judgment of the prescribing physician, and the like. Following this or similar procedures, those skilled in the art will be able to prepare a variety of formulations.




Active agents of the present invention may also be cellular by nature. Cells which can be loaded into the delivery implant of the current invention include, but are not limited to, bone marrow cells, stromal cells, stem cells, embryonic stem cells, chondrocytes, osteoblasts, osteocytes, osteoclasts, fibroblasts, pluripotent cells, chondrocyte progenitors, endothelial cells, macrophages, leukocytes, adipocytes, monocytes, plasma cells, mast cells, umbilical cord cells, mesenchymal stem cells, epithelial cells, myoblasts, islet of langerhom, and precursor cells derived from adipose tissue. The cells can be loaded into the delivery implant of the present invention for a short period of time, e.g. less than one day, just prior to implantation, or cultured for longer a period, e.g. greater than one day, to allow for cell proliferation and matrix synthesis within the delivery implant prior to implantation.




Cells typically have at their surface, receptor molecules which are responsive to a cognate ligand (e.g., a stimulator). A stimulator is a ligand which when in contact with its cognate receptor induce the cell possessing the receptor to produce a specific biological action. For example, in response to a stimulator (or ligand) a cell may produce significant levels of secondary messengers, like Ca


+2


, which then will have subsequent effects upon cellular processes such as the phosphorylation of proteins, such as (keeping with our example) protein kinase C. In some instances, once a cell is stimulated with the proper stimulator, the cell secretes a cellular messenger usually in the form of a protein (including glycoproteins, proteoglycans, and lipoproteins). This cellular messenger can be an antibody (e.g., secreted from plasma cells), a hormone, (e.g., a paracrine, autocrine, or exocrine hormone), or a cytokine.




The following examples are illustrative of the principles and practice of this invention. Numerous additional embodiments within the scope and spirit of the invention will become apparent to those skilled in the art.




EXAMPLE 1




(A Prototypical Implant Insertion Device


10


)




A 10 μl glass syringe (part# 701RN, Hamilton Company, Reno, Nev.) with a removable needle was purchased. A thin-walled, 18° pointed, 20 gauge needle, 1.125-inches long was also purchased (Popper and Sons, Inc., New Hyde Park, N.Y.). Collars and gaskets were machined using 316 stainless steel and poly(tetrafluoro ethylene) (sold under the tradename TEFLON by E.I. duPont, Wilmington, Del.), respectively. The dimensions of both were 0.105-inch height×0.125-inch diameter). Through the center of each collar and gasket was drilled a 0.0355-inch diameter hole. The collar was press-fit onto the 20 gauge needle, with the distal end of the collar 0.2-inch from the proximal end of the needle. The TEFLON gasket was then press-fit onto the proximal end of the needle and seated snugly against the proximal end of the collar. A 0.042-inch diameter hole was drilled in the center of the threaded, knurled cap. The distal end of the needle was placed first through the proximal end of the hole in the cap and pulled through until the distal end of the press-fit collar was seated on the inside of the cap. A 316 stainless steel plunger 4.188 inches in length was centerless ground to a diameter of 0.0185±0.0002-inch. To one end of this plunger was press-fit a stainless steel flange for the thumb.




EXAMPLE 2




(A Prototypical Delivery Implant)




Tubing was melt extruded from an elastomeric copolymer of ε-caprolactone (CAP) and glycolide (GLY) having a mole ratio of ε-caprolactone to glycolide of about 35/65 (35/65 CAP/GLY, Ethicon, Inc., Somerville, N.J.). The inherent viscosity (IV) of the 35/65 CAP/GLY was about 1.3 deciliters per gram (dL/g), as measured in a 0.1 g/dL solution of hexafluoroisopropanol (HFIP) at 25° C. The tubing had an outer diameter of approximately 0.0256 inches and an inner diameter of approximately 0.0177 inches. Pieces of this tubing 1-inch in length were cut with a razor blade. The inside of each piece of tubing was filled with about 2 mg of fibers composed of 90/10 copolymers of poly(glycolic acid) with poly(lactic acid) (PGA/PLA), sold under the tradename VICRYL (Ethicon, Inc., Somerville, N.J.). As this example teaches, the present invention comprehends a delivery implant


40


, the hollow


27


of which is partially filled with filler


31


(shown diagrammatically in

FIG. 4

) such as fillers, fibers or a foam into which the active agent


44


infiltrates. Such fillers can be advantageous with respect to holding and metering out liquid active agents


44


to assist in controlled release of the active agent


44


.




EXAMPLE 3




(Illustrating the Operation of the Implant Insertion Device


10


)




A solution was made containing ˜0.1% Nigrosin dye (Aldrich Chemicals, Milwaukee, Wis., part # 19,828-5) in deionized water. Approximately 2.5 μl of this die solution was drawn into the syringe barrel through a 30 gauge needle. The 30 gauge needle was then removed from the syringe barrel. A fiber-filled 1-inch long piece of tubing from Example 2 was placed into the proximal end of a 20 gauge needle from Example 1. The needle assembly was attached to the syringe barrel. The plunger was depressed until the fiber filled tube was expelled out the end of the needle. Upon inspection the tube was filled with the dyed liquid.



Claims
  • 1. A system for implanting medicinal implants into the body of a living creature, comprising:an injector body with a first lumen therein; a plunger slideable within said first lumen between a retracted position and a deployed position; a needle having a second lumen therein, said needle coupled to said injector body with said second lumen communicating with said first lumen; and an injectable implant having a hollow interior and positionable within at least one of said first lumen and said second lumen, said hollow interior communicating with said first lumen; and a medicament, storable at least partially within said first lumen separate from said injectable implant to prevent interaction therebetween when said plunger is in said retracted position, said hollow interior of said injectable implant receiving at least a portion of said medicament when said plunger is moved from said retracted position to said deployed position, said plunger pushing said injectable implant through said second lumen and out of said needle when said plunger assumes said deployed position.
  • 2. The system of claim 1, wherein said implant is biodegradable and provides a selected rate of release of said medicament into the body of the creature.
  • 3. The system of claim 2, wherein said injectable implant is formed from a material selected from the group consisting of biodegradable polymers, biopolymers, bioabsorbable starches and blends thereof.
  • 4. The system of claim 1, wherein a phase of said medicament is selected from the group consisting of solid, liquid, gel, suspensions and paste.
  • 5. The system of claim 4, wherein said medicament has an active agent component selected from the group consisting of antibiotics, antiviral agents, anticancer agents, anti-rejection agents, analgesics, anti-inflammatory agents, hormones, antigens, cyotkines, attachment factors, genes, peptides, proteins, nucleotides, carbohydrates, cells, cell fragments, growth factors, polysaccharides, glycoproteins and lipoproteins.
  • 6. The system of claim 1, wherein said injectable implant has an input opening to admit said medicament and a vent to discharge gas displaced by said medicament.
  • 7. The system of claim 6, wherein said injectable implant is substantially tubular in shape.
  • 8. The system of claim 6, wherein said injectable implant has cross-sectional dimensions approximating the cross-sectional dimensions of said first lumen.
  • 9. The system of claim 1, further including a filler disposed within said hollow interior of said injectable implant, said medicament diffusable into said filler.
  • 10. The system of claim 9, wherein said filler is a biodegradable fiber.
  • 11. The system of claim 1, wherein said injectable implant has a friction fit relationship relative to at least one of said first lumen and said second lumen.
  • 12. The system of claim 1, further including a seal disposed in a distal end of said first lumen, said seal retaining said medicament within said first lumen when said plunger is in said retracted position.
  • 13. The system of claim 12, wherein said seal is a removable plug.
  • 14. The system of claim 12, wherein said seal is a rupturable membrane.
  • 15. The system of claim 1, wherein said needle is removably coupled to said injector body.
  • 16. The system of claim 15, wherein said injector body includes an elongated cylindrical barrel with a threaded nipple at a distal end thereof, said needle having a peripheral collar disposed proximate a first end thereof and further comprising a needle retention cap having a threaded bore terminating in a bridging cap member with a needle bore therein for accommodating said needle therethrough, said threaded bore being threadedly receivable on said threaded nipple, said bridging cap member abutting said peripheral collar for urging said needle toward said threaded nipple when said needle retention cap is threadedly received thereon.
  • 17. The system of claim 16, wherein said nipple has a needle aperture therethrough communicating with said first lumen, said needle aperture slideably receiving said first end of said needle, and further comprising a gasket slideable over said needle proximate said first end, said gasket being captured between said collar and said nipple when said needle retention cap is received on said nipple.
  • 18. The system of claim 15 wherein said needle is removably coupled to said injection body by a Leur-type connector.
  • 19. A method for introducing a medicament into the body of a living creature, comprising the steps of:(A) providing an injector having a first lumen therein, a plunger slideable within the first lumen between a retracted position and a deployed position and a needle with a second lumen disposed at one end of the injector for penetrating the body of the creature; (B) providing an injectable implant with a hollow interior; (C) charging the first lumen with a medicament; (D) inserting the injectable implant into the second lumen; (E) maintaining the injectable implant and the medicament separate to prevent chemical interaction therebetween after completion of said steps of charging and inserting; (F) penetrating the body of the creature with the needle; and (G) moving the plunger from the retracted position to the deployed position, the plunger moving the medicament into the hollow interior of the injectable implant as it moves from the retracted position towards an intermediate position contacting the injectable implant and pushing the injectable implant out of the needle and into the body of the creature as the plunger moves to the deployed position.
  • 20. The method of claim 19, further comprising the step of assembling the needle to the injector just prior to moving the plunger in said step G.
  • 21. The method of claim 20, further comprising the step of sterilizing the injector and the injectable implant separately from the medicament and prior to moving the medicament into the hollow interior of the injectable implant in said step G.
  • 22. The method of claim 19, wherein the medicament has approximately the same volume as said hollow interior.
  • 23. The method of claim 19, wherein the medicament includes living cells and further comprising the step of waiting to move the plunger after the plunger has reached the intermediate position in order to allow the cells to interact with the injectable implant prior to penetrating the body with the needle and prior to injecting the injectable implant into the body of the creature.
  • 24. The method of claim 19, further comprising the steps of (E2) packaging the injector after said steps of (C) charging and (D) inserting and during said step (E) of maintaining and subsequently (E3) unpacking the injector while still performing said step of maintaining and prior to said step (F) of penetrating.
  • 25. The method of claim 19, further comprising the steps (H) of retaining medicament in the hollow interior of the injectable implant after said step (G) of pushing and (I) releasing the medicament from the hollow interior into the body of the creature over a period of from 2 to 800 hours.
  • 26. A method for introducing a medicament into the body of a living creature, comprising the steps of:(A) providing an injector having a first lumen therein, a plunger slideable within the first lumen between a retracted position and a deployed position and a needle with a second lumen disposed at one end of the injector for penetrating the body of the creature; (B) providing an injectable implant with a hollow interior; (C) charging the first lumen with a medicament; (D) sealing the medicament in the first lumen; (E) inserting the injectable implant into the second lumen; (F) penetrating the body of the creature with the needle; (G) overcoming the sealing of the medicament in the first lumen; and (H) moving the plunger from the retracted position to the deployed position, the plunger moving the medicament into the hollow interior of the injectable implant as it moves from the retracted position towards an intermediate position contacting the injectable implant and pushing the injectable implant out of the needle and into the body of the creature as the plunger moves to the deployed position.
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