Implantate package, system and method

Implantates are packaged in means 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 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 the means used to implant the implantate subcutaneously in the body of an animal. Thus, using the system of this invention, 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.

This invention relates to a new package and system 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 synonomous 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 animals'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 estradial, 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 frequently under 
dirty conditions. 
This invention permits the handling of implantates at such remote sites 
without their contamination. In this invention, implantates are packaged 
in means 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 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 the means 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 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 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.

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 polyvinylchloride 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 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 end on the implantate removal tool without 
rupture of the film 12 as shown in FIGS. 1, 2, 4, and 7. The ends 16 can 
include depending portions 18, 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 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 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 
three-sixteenths 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 walls 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 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 completely encompassed by tubular member 31 within the 
cell 13 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 
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 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 
organopolysiloxane composition containing a growth 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. 
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.