IE48947B1 - Implantate package - Google Patents

Abstract

One or more implantates are packaged in a package comprising a carrier in the form of a rectangular substrate 11 having sufficient size to permit it to be easily handled, and a film 12 carried by said carrier and shaped to form one or a plurality of and parallel closed cells 13 arranged perpendicular and adjacent to one edge of the rectangular substrate shaped each of the cells to permit an implantate removal tool 30 to rupture and enter the end of each cell and remove the implantate. The implantate removal tool can be used to implant the implantate in the body of an animal. Together the implantate package and implantate removal tool permit aseptic implantation in an animal at a remote site.

Description

This invention relates to a package for use with implantates.

Implantates have been developed to introduce cherapeutic agents ir.to the body of an animal by providing uniform release of drugs over long periods cf time, ouch implantates comprise a drug carrier formed of an crganopolysiloxane rubber composition (more generally known as silicone rubber) which is nonreactive toward the drug, non-toxic to the body, and inown to be compatible with living tissue even after a prolonged implantation period. The drugs are in powder or semi-solid or liquid form, and generally have appreciable solubility in the polymer composition of the organopolysiloxane rubber composition. Such drugs are introduced from the carrier into the body of the animal by diffusion or migration interstitially between the elastomer molecules to the outer surface of the carrier from which tr.ey are removed by the animal's oody fluids. The term drug is used in its broad 2o sense as synonymous with therapeutic agents, medicaments, and tne like, and is intended to include hormones, vitamins, antibiotics, anticoagulants, cancericidal agents, spermicidal agents, vasoactive agents, and other medicinals and medications effective to treat undesirable conditions existing in or on an animal body or ir. an animal's body fluids.

Such implantates are not eroded by the animal's body fluids and permit the exposure of the animal to the effect of the drug to be terminated at will by removal of the implantate. With termination of exposure of the animal to the effects of the drug thus controllable, a livestock owner has the ability to more rapidly meet the demands of the marketplace by electing to shorten the time between treatment of the animal with a drug, such as a growth stimulant, and slaughtering of the animal for use.

To provide treatment of animals, for example with estradiol, and permit termination of such treatment, implantates in tubular form having lengths on the order of an inch or more and diameters of a significant fraction of an inch are used. The insertion of such implantates into the animal's body must frequently take place at a remote site, such as at a livestock ranch or at feeder lots in the field. Furthermore, the insertion of such implantates must be performed by ranch and field hands freqently under dirty conditions.

The invention provides a package of one or more implantates removable by use of an implantate removal tool comprising a carrier in the form of a rectangular substrate being of sufficient size to permit it to be easily handled, and a film carried by said carrier and shaped to form one or a plurality of and parallel closed cells arranged perpendicular and adjacent to one edge of the rectangular substrate, the film being indented at one end of the cell, or of each cell, adjacent the edge of the rectangular substrate to permit its rupture by the sharpened oblique end of the tubular bore of the implantate removal tool, the other end of the cell or each of the cells being tapered so as to mate with the sharpened oblique end of the implantate removal tool and being provided with a hollow depending portion forming an internal implant abutment so as to urge the implantate into the implantate removal tool.

The package of the invention permits the sterile subcutaneous implantation of an implant without exposure of the implant to contamination, by providing an implant within a closed cell formed from a film capable of aseptic treatment to permit the handling and transport of the implant without contamination, and allowing the rupture of the closed cell with an implanter at the site of use, so that it encompasses the implant within the implanter while it is within the cell and allows removal of the implant from the cell for use.

Thus the invention permits the handling of implantates at such remote sites without their contamination. In the package of the invention, the closed cell is formed by a film which includes portions shaped to assist rupture and entry of the cell by the tool and to assist in encompassing the implantate within the tool for its removal from the cell. The tool used in this system can be used to implant the implantate subcutaneously in the body of an animal.

A plurality of sterile implantates can be so provided for use at a remote site with such a package. In such a specific form, the package can include a relatively rigid substrate with an adhering film to form a plurality of in5 dividual cells for the implantates, arranged adjacent the edge of the substrate. The film is indented at the end of each cell adjacent the edge of the card for engagement and rupture by an implantate removal tool. At the end remote from the edge of the substrate, the film is tapered to accommodate an oblique sharpened end on the implantate removal tool without rupture of the film, and the substrate can form a flap that is folded over the tapered ends of the cells to permit the package to be more easily handled and to protect the hand of the user from the sharpened end of the implantate removal tool. In one particularly 8 9 4 7 desirable embodiment of the package, the film carried oy the substrate is shaped to form a plurality of elongated and parallel closed cells arranged perpendicular to and adjacent to one edge of the substrate.

Thus an implantate can be provided within a closed cell which is capable of aseptic treatment and transported to a remote site for use. At such a site, the closed cell can be ruptured with an implanter and the implantate can be encompassed within the implanter and removed from the cell for implantation. Such a system and method is capaole of maintaining an implantate in a sterile condition during transportation and handling and will permit removal of the implantate for use at a remote site without contamination of the implantate through handling.

Other features and advantages of this invention will oe apparent from the following specification and from the drawings in which: Fig. 1 is a perspective view of a package of this invention, with a portion broken away to show a complete closed cell; Fig. 2 is a cross-sectional view of the package of Fig. 1, taken perpendicularly to a vertical plane through the center of one of the closed cells; Fig. 3 is a cross-sectional view along the longitudinal axis of one of the cells taken in the direction of its end remote from the edge of the package as shown by line 3-3 of Fig. 2; Fig. 4 is a perspective view of the end of one of the cells remote from the edge of the package; Fig. 5 is a perspective view of the package of Fig. 1 and shows an implant removal tool positioned to enter the package for removal of an implantate within one of the cells; Fig. 6 is a cross-sectional view through the center of one of the closed cells of the package of Fig. 5 showing the implant removal tool engaging the end of the closed cell adjacent the edge of the package; and Fig. 7 is a cross-sectional view through the center of the cell of Fig. 6 showing the implant removal tool in cross section within the cell and encompassing the implantate for removal from the package.

The preferred embodiment of the invention illustrated herein includes a plurality of cells incorporated into a single package; however, the features of the invention are suited for use in packages containing a single cell.

Fig. 1 is a perspective view of a package 10 of this invention. Such package means forms a closed cell for an implantate, is capable of aseptic treatment, and has a portion adapted for engagement, rupture, and entry by a tool to permit removal of the implantate from the cell. The package can be formed from a relatively rigid substrate 11 such as paperboard ten to twenty thousandths of an inch thick, and a relatively rigid film 12 such as a polyvinylchloride film approximately three to seven thousandths of an inch thick. 8 9 4 7 In tne embodiment shown, the film 12 forms a plurality of cells 13 arranged adjacent an edge of the substrate 11. Each of the cells 13 is elongated to contain an elongated implantate 14, as shown in Fig. 2.

The film 12 thus forms a plurality of elongated closed cells 13 which are parallel and perpendicular to one edge of the rectangular substrate, with one end 15 adjacent the edge of the rectangular substrate and the other end 16 remote from the edge of the substrate.

The portion of the film 12 forming the ends 15 adjacent the edge of the substrate is provided with indentations 17, as shown in Fig. 2. The indented ends 15 are thus shaped to engage the end of an implantate removal tool to assist in rupturing the film 12 at the end of the cell and in the entry of the tool into the cell. The cross section of each closed cell 13 as shown in Fig. 3 is preferably straight-sided with a semi-cylindrical upper portion. At the ends 16 of each cell 13 remote from the edge of the substrate, the film 12 is shaped to accommodate a sharpened oblique end on the implantate removal tool without rupture of the film 12 as shown in Figs. 1. 2, 4, and 7. The ends 16 include depending portions 18 forming an internal abutment, as shown in Figs. 2, 3, 4, and 7 to engage an end of the implantate 14 so that the implantate 14 can be completely encompassed by the sharpened end of the implantate removal tool, and the remaining portions 19 of the ends 16 is shaped to mate the sharpened end of an implantate removal tool. Each cell 13 may be provided with an indented wall portion 20 formed Dy the film 12 between the ends 15 and 16 of 8 9 4 7 cells to prevent buckling of the flexible elongated implantate 14 and to assist the implantate 14 within the encompassing tool.

The rectangular substrate 11 can form a flap 21 that can be folded over the ends 16 of the cells to permit the package to be more easily grasped and to provide an additional measure of protection for the hand of the user in the event the sharpened end of the implant removal tool may accidentally rupture the film 12 adjacent end 16.

Packages of this invention can be of any size, but one particularly convenient size is formed with a rectangular card approximately six and one-half inches wide and four and three-quarters inches long.

Ten closed cells can be formed like blisters on the card by a transparent polyvinylchloride film attached to and carried by the card. Each cell formed by the plastic film is approximately two and three-quarters inches in length with a cross-sectional area approximately one-quarter of an inch high and one-quarter of an inch wide to accommodate elongated flexible tubular implantates about one and one-quarter inches long and about threesixteenths of an inch in diameter.

In the manufacture of such packages, a polyvinylchloride film is molded into the cell configuration that is wanted, and in this molding step some control of wall thickness can be obtained to provide more rigidity to the side wall of the cells, reduced thickness at the ends of the cells to be opened and greater thickness at the ends of the cells that are exposed to 8 9 4 7 a sharpened end of the removal tool. A cardboard substrate having a heat-sealable adhesive coating is used, and the film is preferably attached to the substrate by adhesion of planar portions of the film adjacent the cells with this coating.

The package of this invention can also comprise an implantal tool 30 to engage and rupture the package and to encompass and carry the implantate from within the package. Such a tool for removal of the implantate can be the means used to implant the implantate and can have a sharpened tubular member 31 having a straight bore and an end 32 obliquely sharpened at an acute angle.

As shown in Fig. 5, the implanter includes an ejector 33 operable by a tab 34 to eject the implantate 14 from within the tubular member 31, for example, after the sharpened end 32 has pierced the skin of an animal for location of the implantate 14 under the skin of the animal. The sharpened end 32 will engage the indentation 17 at the end 15 of closed cell 13 adjacent the edge of the substrate 11 as shown in Fig, 5 and Fig. 6. The indented end 15 locates the tool end and assists in the rupture of the film 12 by the sharpened end 32 of the removal tool. After the film 12 is ruptured by the end 32 of the tool, the tubular member 31 enters and slides within the cell 13. As shown in Fig. 7, implantate 14 is engaged by portion 18 of the film 12 at the end 16 of the cell remote from the edge of the card. The remainder 19 of the end 16 of the cell remote from the edge of the card accommodates and mates the sharpened end 32 of tool 30, as shown in Figs. 6 and 7, and as shown in Fig. 7, portion 18 permits implantate 14 to be 6 9 4 7 completely encompassed by tubular member 31 within the cell 13 so that it may be carried and removed frcm the cell by the tubular member. The indented wall means 20 assists the user in locating a flexible implantate 14 within the opening of the sharpened end 32 of the tubular member 31 by preventing its buckling within the cell, and the removal of the implantates from the package is further assisted by use of a film 12 that is transparent.

An example of a package of this invention includes an implantate about one and one-quarter inches long and chree-sixteenths of an inch in diameter comprising an organopolysiloxane composition containing a grcwth stimulant such as twenty-four milligrams of estradial.

Such an implantate can be provided within a closed cell formed from a polyvinylchloride film of a few mils thickness capable of sterile handling. The implantate thus enclosed may be handled and transported without contamination to a rural feeder lot for use. An implanter having a sharpened tubular member about one-quarter inch in diameter can be used to rupture the closed cell and to encompass the implantate while it is within the cell for removal of the implantate from the cell. Upon removal of the implantate from the cell, the implanter may be used to pierce the skin of a steer's ear and to eject the implantate subcutaneously within the ear of the steer. In this method, where a plurality of sterile implantates are to be used, they may be provided at such a remote site within a plurality of contiguous closed cells which have been treated to maintain a sterile condition. A user can, by grasping the plurality of contiguous closed cells in one hand and the implanter in the other hand, engage the indented end of a cell with the sharpened tubular end of the implanter, rupture the end of the cell and encompass the implantate within the cell for removal and implantation.

The specific embodiment of the invention shown and described above is capable of modification without departure from the scope of the following claims.

Claims (7)

1. CLAIMS:1. A package of one or more implantates removable by use of an implantate removal tool comprising a carrier in the form of a rectangular substrate being of sufficient size to permit it to be easily handled, and a film carried by said carrier and shaped to form one or a plurality of and parallel closed cells arranged perpendicular and adjacent to one edge of the rectangular substrate, the film being indented at one end of the cell, or of each cell, adjacent the edge of the rectangular substrate to permit its rupture by the sharpened oblique end of the tubular bore of the implantate removal tool, the other end of the cell or each of the cells being tapered so as to mate with the sharpened oblique end of the implantate removal tool and being provided with a hollow depending portion forming an internal implant abutment so as to urge the implantate into the implantate removal tool.

2. A package of claim 1 wherein the rectangular substrate forms a flap that is folded over the tapered ends of the cells to permit the carrier to be more easily grasped and to protect the user.

3. A package of claims 1 or 2 wherein the film forms indented wall portions in the cells between their ends to prevent buckling of the implantates within the cells.

4. A package of any of claims 1, 2 or 3 wherein the film is capable of aseptic treatment.

5. A package of any of claims 1-4 wherein the rectangular substrate is relatively rigid and comprises a rectangular paper board card.

6. A package according to any of claims 1 to 5 and an implantate removal tool.

7. A package substantially as hereinbefore described with reference to, and as illustrated in the accompanying drawings.