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  
         [0001]    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  
         [0002]    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.  
           [0003]    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  
         [0004]    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  
       [0005]    [0005]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;  
         [0006]    [0006]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;  
         [0007]    [0007]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;  
         [0008]    [0008]FIG. 4 is an enlarged view of a segment of the device shown in FIG. 3; and  
         [0009]    [0009]FIG. 5 is a cross-sectional schematic view of the device of FIGS.  14  as the delivery implant is being administered under the skin of a living subject. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0010]    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.  
         [0011]    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.  
         [0012]    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 .  
         [0013]    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 .  
         [0014]    In the alternative, the needle  22  can be attached to the barrel  20  via a Luertype fitting, a fitting which is well known in the art. (LUER-LOK) is a registered trademark of Becton, Dickinson and Company, of Franklin Lakes, New Jersey. 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.  
         [0015]    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 .  
         [0016]    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.  
         [0017]    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.  
         [0018]    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 .  
         [0019]    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 .  
         [0020]    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.  
         [0021]    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.  
         [0022]    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.).  
         [0023]    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.  
         [0024]    [0024]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 .  
         [0025]    [0025]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 .  
         [0026]    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 .  
         [0027]    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 patient, 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.  
         [0028]    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.  
         [0029]    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 .  
         [0030]    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 .  
         [0031]    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 .  
         [0032]    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  10  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.  
         [0033]    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.  
         [0034]    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.  
         [0035]    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&#39;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-β, I-III), vascular endothelial growth factor (VEGF); and other naturally derived or genetically engineered proteins, polysaccharides, glycoproteins, or lipoproteins.  
         [0036]    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.  
         [0037]    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.  
         [0038]    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 langerhorn, 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.  
         [0039]    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.  
         [0040]    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 )  
       [0041]    A 10 μl glass syringe (part# 701 RN, 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)  
       [0042]    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) (PGANPLA), 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 )  
       [0043]    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.