GB2031836A

GB2031836A - Implantate package, system and method

Info

Publication number: GB2031836A
Application number: GB7933320A
Authority: GB
Original assignee: Eli Lilly and Co
Current assignee: Eli Lilly and Co
Priority date: 1978-09-27
Filing date: 1979-09-26
Publication date: 1980-04-30
Also published as: BR7906076A; AU530749B2; IE48947B1; ES251440Y; FR2437218B1; AR221621A1; CA1146027A; FR2437218A1; ES484535A1; IE791829L; AU5109379A; GB2031836B; ZA795035B; MX6388E; ES251440U

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. <IMAGE>

Description

SPECIFICATION Implantate package, system and method This invention relates to a new package, system and method for use with implantates.

Implantates have been developed to introduce therapeutic agents into the body of an animal by providing uniform release of drugs over long periods of time. Such implantates comprise a drug carrier formed of an organopolysiloxane rubber composition (more generally known as silicone rubber) which is non-reactive toward the drug, non-toxic to the body, and known 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 they are removed by the animal's body fluids.The term "drug" is used in its broad sense as synonymous with therapeutic agents, medicaments, and the 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 in 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 be 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 a livestock ranch or at feeder lots in the field. Furthermore, the insertion of such implantates must be performed by ranch and field hands frequently under dirty conditions.

This invention provides a package for one or more implantates comprising a carrier in the form of a rectangular substrate having 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 shaped at one end of each of the cells adjacent the edge of the rectangular substrate to permit its engagement by an implantate removal tool so that the end of each cell is easily ruptured and entered by the implantate removal tool, each of said cells further being shaped to permit insertion of the implantate removal tool into each cell with the film at the other ends of the cells urging the implantate carried within the cell into the implantate removal tool.

The invention also provides a system adapted to permit the sterile subcutaneous implantation of an implant comprising an implant package formed from a substrate and a film capable of aseptic treatment and including a portion adapted for engagement, rupture and entry by an implanter, and carrying a subcutaneous implant, and an implanter adapted to engage and rupture said portion of the film and to enter said implant package and encompass the implant within the package and to remove and carry the implant for ejection subcutaneously.

This invention further provides a method permitting subcutaneous implantation without exposure of the implant to contamination, comprising 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, rupturing the closed cell with an implanter at the site of use, encompassing the implant with the implanter while it is within the cell and removing the implant from the cell for use.

This invention permits the handling of implantates at such remote sites without their contamination. In this invention, implantates are packaged in a package capable of aseptic treatment and forming a closed cell having a portion adapted for engagement, rupture and entry by a tool that permits removal of the implantate for use without handling of the implantate by the user. In such a package, the closed cell is formed by a film which includes portions shaped to assist rupture and entry of th 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 individual cells for the implantates, arranged adjacent the edge of the substrate.

The film is shaped 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 can be shaped to accommodate a sharpened end on the implantate removal tool without rupture of the film, and the substrate can form a flap that is foldable over the remote 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 desirable embodiment of the package, the film carried by 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, using the system of this invention, an implantate can be provided within a closed cell which is capable of aseptic treatment and trans ported 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 a system and method is capable 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 be apparent from the following specification and from the drawings in which: Figure 1 is a perspective view of a package of this invention, with a portion broken away to show a complete closed cell; Figure 2 is a cross-sectional view of the package of Figure 1, taken perpendicular to a vertical plane through the center of one of the closed cells; Figure 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 Figure 2; Figure 4 is a perspective view of the end of one of the cells remote from the egde of the package;; Figure s is a perspective view of a system of the invention including the package of Figure 1 and an implant removal tool positioned to enter the package for removal of an implantate within one of the cells; Figure 6 is a cross-sectional view through the center of one of the closed cells of the package of Figure 5 showing the implant removal tool engaging the end of the closed cell adjacent the edge of the package; and Figure 7 is a cross-sectional view through the center of the cell of Figure 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.

Figure 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 polyvinylchlor ide film approximately three to seven thousandths of an inch thick.

In the 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 Figure 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 Figure 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 Figure 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 end on the implantate removal tool without rupture of the film 12 as shown in Figures 1,2,4 and 7. The ends 16 can include depending portions 18, as shown in Figures 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 can be shaped to mate the sharpened end of an implantate removal tool.Each cell 13 may be provided with an indented wall portion 20 formed by the film 12 between the ends 15 and 16 of cellsto 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 bythe 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 three-sixteenths of an inch in diameter.

In the manufacture of such packages, a polyviny- Bichloride 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 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 system of this invention includes a second means 30 in the form of a tool 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 sharpened at an acute angle.

As shown in Figure 5, the implanter includes an ejector 33 operable by a tab 34 to eject the implantate 14from 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 Figure 5 and Figure 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 Figure 7, implantate 14 is engaged by portion 18 ofthefilm 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 Figures 6 and 7, and as shown in Figure 7, portion 18 permits implantate 14to be completely encompassed by tubular member 31 within the cell 1 3 so that it may be carried and removed from 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 member31 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 method of use of the system and package of this invention can include the use of an implantate about one and one-quarter inches long and three-sixteenths of an inch in diameter comprising an organopolysilaxone composition containing a growth stimulant such as twenty4our 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.

Thus, the package, system, and method are adapted to permit the sterile handling of an implantate by the use of first means forming a closed cell for the implantate, being capable of aseptic treatment, and having a portion adapted for engagement, rupture, and entry by a second means adapted to engage the said portion of the first means and to rupture and enter the closed cell and encompass the implantate within the cell for removal and use. This system permits the subcutaneous implantation of implants without exposure of the implant to contamination in handling and transportation at a remote site of use.

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

Claims

claims. CLAIMS

1. A package for one or more implantates comprising a carrier in the form of a rectangular substrate having 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 shaped at one end of each of the cells adjacent the edge of the rectangular substrate to permit its engagement by an implantate removal tool so that the end of each cell is easily ruptured and entered by the implantate removal tool, each of said cells further being shaped to permit insertion of the implantate removal tool into each cell with the film at the other ends of the cells urging the implantate carried within the cell into the implantate removal tool.

2. A package of claim 1 wherein the film at the other end remote from the edge of the substrate is shaped to accommodate the sharpened end on the implantate removal tool without rupture of the film, and the rectangular substrate forms a flap that is foldable at the remote 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 to 4 wherein said relatively rigid substrate is a rectangular paperboard card of such size that it is easily grasped by hand, said plurality of cells formed by said film are elongated and arranged in a parallel array with one end of each cell located closely adjacent one edge of the card, and said film is plastic and forms indentations at the ends of the cells to engage the implantate carrier and assist rupture of the ends and entry of the implantate carrier within the cells.

6. A system adapted to permit the sterile subcutaneous implantation of an implant comprising an implant package formed from a substrate and a film capable of aseptic treatment and including a portion adapted for engagement, rupture and entry by an implanter, and carrying a subcutaneous implant, and an implanter adapted to engage and rupture said portion of the film and to enter said implant package and encompass the implant within the package and to remove and carry the implant for ejection subcutaneously.

7. The system of claim 6 wherein said implant package forms one or more elongated cells from a relatively rigid transparent plastic film, and said implanter includes a tubular member with a straight bore and a sharpened end, and the portion of the first means adapted for engagement, rupture and entry by an implantate carrier is an indented end of the film forming the cell to position the sharpened end of the implanter so that the sharpened end pierces the plastic film, said implant package permitting the tubular carrier to slide easily within an elongated cell and urging the implantate to enter within and be carried by the tubular member.

8. The system of claims 6 or 7 wherein said implant package inculdes a relatively rigid substrate and a film that is attached to said substrate and, with said substrate, forms a plurality of blister-like cells arranged in an array adjacent an edge of the substrate, said portion adapted for engagement, rupture and entry includes portions of the film forming the cells and close to the edge of the substrate.

9. The system of any of claims 6 to 8 wherein said implants includes a tubular member with a straight bore and sharpened end, said relatively rigid substrate is a rectangular paperboard card of such size that it is easily grasped by hand, said plurality of cells formed by said film are elongated and arranged in a parallel array with one end of each cell located closely adjacent one edge of the card, said film forms indentations at said ends of the cells to engage the sharpened end of the tubular member of the second means and assist rupture of the ends and entry of the tubular member within the cells and, further, said film, at the end of the cells remote from the edge of card, is shaped to accommodate the sharpened end of the tubular member without rupture of the film, and the rectangular paperboard and forms a flap that is foldable at the remote ends of the cells to permit the first means to be more easily grasped by hand and to protect the hand of the user.

10. A method permitting subcutaneous implantation without exposure of the implant to contamination, comprising 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, rupturing the closed cell with an implanter at the site of use, encompassing the implant within the implanter while it is within the cell and removing the implant from the cell for use.

11. The package for one or more implantates according to claim 1 substantially as herein described.

12. The system adapted to permit the sterile subcutaneous implantation of an implant according to claim 6 substantially as herein described.

13. The method permitting subcutaneous implantation without exposure of the implant to contamination according to claim 10 substantially as herein described.

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