Injection device for artificial insemination having a disposable dispensing capsule with detachable actuator

June 21, 1966 h. j. hill etal 3,256,884

INJECTION DEVICE FOR ARTIFICIAL· INSEMINATION HAVING

A DISPOSABLE DISPENSING CAPSULE

WITH DETACHABLE ACTUATOR

Filed April 15, 1963

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ATTORNEY

3,256,884

Patented June 21, 1966

United States Patent Office

3,256,884

INJECTION DEVICE FOR ARTIFICIAL INSEMINATION HAVING A DISPOSABLE DISPENSING CAPSULE WITH DETACHABLE ACTUATOR

Harold J. Hill, Box 382, Topeka, Kans., and Donald M. Culver, Lafayette, and Ray L. Hauser, Boulder, Colo.; said Culver and said Hauser assignors to said HiJI

Filed Apr. 15,1963, Ser. No. 272,994 4 Claims. (Cl. 128—235)

This invention relates to an applicator apparatus and method for the injection of fluids into the body; more particularly, it relates to an applicator apparatus of the type having an actuator for a capsule which may be used as a sealed sterile container for fluid.

The invention is illustrated herein for the purpose of explanation by its application as an impregnator for use in the artificial insemination of animals. . However, the invention is not limited to this application but may be used in many other applications involving the introduction of fluids into the body, or transportation and storage of fluids in liquid or frozen state.

In the practice of artificial insemination of domestic or fur bearing animals, semen is commonly injected into the genital tract of the female by the use of a pipette, approximately 5 mm. in diameter and 14 to 18 inches in length having a capacity of 0.5 cc. to 1.5 cc. of fluid. Such pipettes are most commonly manufactured of extruded plastic; however, glass or metal may be used. Fluid is drawn into the pipette by applying suction to the opposite end of the tube. This suction is brought about by attaching a device such as a syringe or a flexible, expansible, contractible bulb to the pipette, the action being to extract the air from the pipette thus allowing entry of the fluid by force of external air pressure on the surface thereof. The fluid is expelled from the pipette by reversing the force of air pressure.

In accordance with conventional practice the seminal fluid extracted from the male is mixed with a suitable fluid designed to maintain life of the spermatozoa, and 40 to dilute their numbers per unit of volume to that minimum which is necessary to bring about fertilization of the egg within the female.

It has been established that six million to twelve million living spermatozoa must be deposited in the proper ⁴⁵location in the female genital tract or cattle in order to assure a satisfactory percentage of pregnancies under normal conditions. With intent to provide a comfortable margin of safety, it is common practice to place twenty to thirty million spermatozoa in each insemination dose, 50 said number of spermatozoa being suspended in .5 cc. to 2 cc. of suitable fluid carrier. The amount of fluid containing this number of spermatozoa is inconsequential; the critical point in question being the number of living spermatozoa ultimately deposited in the female genital ⁵⁵tract during the insemination procedure.

In most instances the seminal fluid, containing a predetermined number of living spermatozoa, mixed with its fluid, is placed in glass ampules in volumes ranging from .5 cc. to 2 cc. The ampule is then heat sealed, the θθ contents frozen according to a specific program, stored at low temperatures (from —110 to —320 degrees F.) until ready for the act of insemination of the female. Containers other than glass have been and are being used, in a very minor scope, throughout the world. θθ

Just prior to actual insemination of the female, the sperm-carrying-container is removed from the low temperature environment and its contents thawed to a liquid state. The container is opened and the tip of the pipette inserted into the fluid while simultaneously suction is 70 applied along the internal cavity of the pipette by action of the syringe or bulb heretofore described.

With the tip of the pipette, containing the necessary minimum number of spermatozoa, is held in proper position with relation to the female genital tract, the contents of the pipette are expelled by the action of air forced 5 through the pipette by the syringe or bulb described heretofore.

In field operation, that portion of the pipette which contacts the mucous membranes of the female genital tract must be practically sterile for obvious reasons. This 10 “practical field sterility” is accomplished by discarding the entire instrument and using a new instrument each time; or by disinfecting in a chemical solution; or by subjecting the instrument to temperatures sufficiently high to destroy the contaminating organisms.

As noted in a prior paragraph the spermatozoa of certain male animals is extremely valuable. It would 'be most beneficial for the livestock industry if the germ plasm from such valuable males is distributed throughout a maximum number of females. Therefore the tech20 niques, devices, equipment, materials and supplies, associated with the most efficient processing of seminal fluids from such males and the distribution and ultimate deposition within the females should be continually improved and modified.

There are a number of serious disadvantages attendant to the use of prior art syringe and bulb devices for the impregnation of animals. They do not provide for measurement of exact amounts of fluid to be drawn from the container nor do they provide for delivery of exact ³⁰ amounts from the pipettes. Because of the large surface area within the long, small calibre pipette there is serious wastage of valuable spermatozoa contained within the film of fluid which remains clinging to the internal wall surface attendant to attempted expulsion of the fluid by ³⁵ action of the prior art type syringe or bulb. It has been determined that 20 to 40% of the volume of fluid drawn into the pipette remains on the internal wall surface of the pipette after the insemination of the cow has been completed. The predetermined numbers of living sperma^υ tozoa suspended in the ejected fluid volume is therefore decreased accordingly.

A second disadvantage of the prior art syringe type instrument is that the fluid containing the valuable sper_4g matozoa must be withdrawn from the container in which it was frozen, stored and delivered before insemination can be accomplished. Considerable wastage of spermatozoa occurs at this point of the technique as it is impossible to extract all of the fluid from the container by the negative action created by suction.

A third disadvantage attendant to the use of prior art syringe devices is the fact that during the period of time the fluid is being withdrawn from the opened container the fluid contents are being exposed to the atmosphere with the resultant probabilty of contamination with undesirable organisms.

A fourth disadvantage involves the fact that retention of the total volume of fluid within the cavity of the pipette is dependent upon equalized air pressures acting on each θθ end of the pipette. Therefore any sudden change in such pressure or handling the syringe device may cause premature discharge of fluid from the pipette, thus reducing the number of spermatozoa ultimately injected into the female. In addition, the contamination of the fluid prior Q5 to entry of the tip of the pipette into the female genital tract is a possibility.

A fifth disadvantage attendant to the use of prior art syringe devices is related to the fact that the living spermatozoa contained within the fluid drawn into the 70 pipette in the form of a long, thin column are immediately vulnerable to adverse atmospheric conditions, such as extremes of temperature, ultra-violet rays of light, sudden

3,256,884 bursts of temperature changes; such adversities causing destruction of a considerable number of valuable spermatozoa prior to the moment the instrument is placed within the protective confines of the female genital tract.

A sixth disadvantage involves the practice of maintaining “practical field sterility” by either discarding the entire pipette and syringe device after each use or discarding the pipette portion only, retaining the syringe or bulb for subsequent inseminations. In the former situation there is an added cost associated with each insemination. In the latter situation there is a serious possibility that spermatozoa from a particular bull used on an initial insemination will have been drawn into the cavity of

4,.

impregnation and the capsules are filled, sealed, stored and shipped to the point of use and their contents ejected without exposure or loss. The invention is best explained with reference to the accompanying drawing hereby made a part of this application and in which like numerals represent like parts and;

FIG. 1 is an elevational sectional view of the actuator of the invention showing the plunger rod in a retracted position;

FIG. 2 is elevational sectional view of the detachable capsule of the invention showing it being used as a storage container with the piston-closure member sealing it;

FIG. 3 is a sectional view of the piston-closure the retained syringe device, and will become incorporated with the fluid medium drawn into the pipette preparatory to a subsequent insemination, thus creating the possibility of a mismating (pregnancy to an unwanted sire) at the subsequent insemination—a serious and costly mistake in the case of purebred, registered cattle.

Sterilization of the syringe device to prevent the disadvantage quoted above with any technique other than heat leaves the walls of the syringe device contaminated with a fluid which will adversely effect the living spermatozoa; heat sterilization of the pipette-syringe device in the field, at the site of the insemination is impractical if not impossible.

A seventh disadvantage attendant to prior art syringe devices is related to the fact that the large majority of semen processing organizations throughout the world distribute the insemination doses in glass ampules which are, by the very nature of glass, susceptible to breakage. Such containers are not uncommonly shattered during handling, during the act of opening the container just prior to withdrawal of the fluid at the moment of insemination, or member; and

FIG. 4 is a fragmentary sectional view showing the capsule attached to the body of the actuator with the plunger rod in the forward position within the capsule.

Referring now to FIG. 1, the numeral 8 indicates the actuator of the applicator apparatus. The hollow body 9 of the actuator may be made of any suitable material, such as stainless steel or aluminum, or resinous or plastic materials. For example, thermoplastic and thermosetting resinous materials available on the market such as polyethylene, phenol-aldehyde resins may be used. The external surface of the body 9 is machined for attachment of the capsule 21 or its lower end is provided with a cap 10 secured integrally therewith and adapted to receive the detachable capsule 21 as will be explained hereinafter. Actually, the cap 10 is a part of body 9, it being noted that the overall body of the capsule terminates in a reduced lower end 11. A cylinder 12, preferably of the same material as the body 9 and of enlarged internal diameter is attached around the top end of the body 9 _______— __________________________, — by conventional means or the body and cylinder may because of expansible gases trapped within the container ^5 be one piece, during the sealing process. ‘

It is therefore an object of this invention to provide an efficient and effective method and apparatus for the impregnation of female animals by artificial insemination.

It is another object of this invention to provide a method as stated which is conducive to the storage, shipment and use of semen under conditions which insure its preservation and use without waste or loss. . It is still another object of this invention to provide an improved apparatus and method including a capsule _4gand actuator therefor which permits loading and ejection of a controlled and measured amount of fluid.

An additional object of this invention is the provision of a method and apparatus for the stated purpose which is highly sanitary and which does not require discarding, as 5θ in the case of pipettes with bulbs, or frequent cleaning of the syringe portion after use, and further one which is economically feasible.

It is a further object of this invention to provide a method and apparatus for the stated purpose which permits the 55 ejection of fluid without its exposure to the atmosphere after its initial packaging and storage by using the same container for storage and injection of semen.

It is another object of the invention to provide an apparatus of the type described including a capsule and 60 actuator therefor which is of simplified construction and operation and which is readily adaptable to manufacturing techniques.

It has been found that the above and other objects can be accomplished and the enumerated disadvantages over- 65 come by the combination of an actuator device provided with a plunger rod which is adapted to extend beyond •the actuator body when actuated, and a detachable capsule functioning as a sterile sealed container for fluid when detached, and which is provided with a severable closure 70 including a piston portion whereby upon severing the closure the piston portion of the closure cooperates with the rod of the actuator to eject fluid from the capsule as the rod is manually actuated. The capsule is dimensioned to hold the precises amount of semen necessary for an 7 5

The cylinder 12 of the actuator 8 is provided with an opening at its upper end and there is an aligned opening with the body 9, all for receiving rod 14. The rod 14 may be of metal or any suitable rigid material and is of ⁴⁰ a length to, due to its extension 15, extend beyond the open end of the body in its forward or actuated position. It is provided with plug 16 securely attached thereto the upper surface of which functions as a stop, acting against the lower surface of the top of cylinder 12, to limit the upward movement of the rod 14 or its movement to its retracted position.

A resilient member in the form of spring 19 is seated between the lower surface of plug 16 and the annular internal shoulder formed at the junction of body 9 and cylinder 12. This spring normally biases the rod 14 in its upward or retracted position. The extension 15 of rod 14 is provided at its upper end with handle means in the form of knob 20 the bottom surface of which may function as a stop acting against the upper surface of cylinder 12 to limit the downward or forward movement of the rod when it is actuated. The knob may be provided with gripping ears or similar construction for ease of operation of the rod. The resilient means may take other forms than the spring 19 such as another type elastic member, diaphragm or other device of similar function. Also, for the obvious advantage of firm anchoring, rod 14 may terminate in a ponited end. FIG. 1 shows the unactuated position of the actuator 8 and it is to be noted that end 11 includes a tapered tip 17 terminating in barbs 18.

Referring to FIG. 2, the cartridge 21 is comprised of a severable substantially cylindrical housing portion 24 having a tapered bullet shaped end 26 which serves as the injection end of the capsule, said injection end terminating in a closed aperture 23. The capsule is preferably constructed of plastic or suitable equivalent material. The material of which the capsule is made (at least at certain areas thereof) must be what is referred to herein as “severable” material, that is, it must be a material which can be readily cut with a sharp cutting edge such as a knife

S,256,884 blade, scissors, clippers, etc. The material of which the capsule is constructed is preferably transparent to permit easy filling of the capsule with fluid to the required height, and to facilitate color identification of the medium and the member 27 contained therein. 5

Referring now to FIGS. 2 and 3, the combination piston and closure member 27 is comprised of a head or plug portion 28 (hereinafter referred to as head) and a piston portion 30 with a reduced stem 32 (hereinafter referred to as piston) connected to the head 28 by a small diam- ₁₀eter connector 34. The entire assembly 27 is made of resilient material such as rubber, natural or synthetic, but can be made of other suitable material such as various plastics. Again, the member 27 must be made of a severable material, at least at the area of connector 34, for a reason 15 which will be explained later and it is preferred to make same of material identical with housing 24 such as of plastic whereby head 28 and the top 29 of housing 24 may be heat sealed.

The piston 30 is preferably provided with flexible an- 20 nular external contact rings 36 which make sealing contact with the internal surfaces of housing 24 of capsule 21. Also, head 28 carries a contact or sealing ring 31. The described construction of the combination closure and piston member 27 is the preferred one; however, other 25 constructions may be used.

It is to be noted that the interior of housing 24 of capsule 21 is provided with an annular raised portion 22 and the location of this raised portion or ridge as well as the cooperation thereof with the depending end 11 is im- 30 portant as will become apparent. Also, the end 11 terminates in a shoulder opposite its barbed end 17-18 and the cooperation of said shoulder with housing 24 is important. Assuming capsule 21 contains the necessary fluid 25 and the user is ready to connect actuator 8 to 35 the caspule 21, first a transverse cut is made through the capsule 21 at the area of connector 34 while the closurepiston member 27 is in the sealing position in the capsule, such a cut being represented by line A—A in FIG. 2. ⁽This does break the main seal of the capsule formed by ⁴⁰head 28 and top 29 but the rings 36 maintain that portion of the capsule ahead of them in a sealed condition. That portion of element 32 below said cut is a part of the piston body and is designed to receive the rod of the actuator 8.

Now the actuator 8 is connected to the capsule 21 by _d5inserting the hollow end 11 within housing 24 with the shoulder at one end of the end 11 abutting the remaining top of the capsule and the barbs 18 snapped into engagement with the ring 22 on the discharge side of the capsule. Of importance is the fact that tip 17 encompasses and _δ0surrounds in spaced relationship a portion of element 32 all to properly align the rod 14 and stem 32 forming a part of piston 30. Also of extreme importance is the fact that the actuator end 11 is of such a length that the shoulder at the upper part of end 11 prevents any engagement 55 of tip 17 and piston 30. There will be no actuation of the piston 30 until rod 14 is actuated. As stated, portion 32 is constructed to fit inside of the tip end 11 so that rod 14 will be guided into contact with the top of piston portion 32 when the capsule 21 is attached to body 9 and ₆₀the plunger 14 is actuated or moved forward. Other means by which the rod may be made to cooperate with the piston portion 32 to properly seat against it may be used but this is the preferable means. As will be seen from FIGS. 1, 2 and 4 the length of the permitted stroke _δδof rod 14 is such that when the capsule is attached to the body 9 of actuator 8 it may be extended only far enough beyond the end of the body 9 to force the piston 30 into the mating internal end of the capsule 21. The relative appropirate dimensions of capsule 21, body 9 including ;q the cap structure 10 thereof, and piston 30 must be such that no pressure will be exerted to force the capsule off of the actuator 8 as fluid is being ejected from the capsule. The bullet shaped capsule and mating end of the piston insures that all fluid is ejected from the capsule. Of 75 ⁶ course as will be mentioned hereinafter the capsule must, before the stroke of piston 30, be severed at B—B to open discharge aperture 23.

The overall operation of the method of the invention and the apparatus described herein is as follows: Seminal fluid is packaged at the bull stud station in capsule 21 by introducing approximately .55 cc. of fluid, or the required amount depending on the situation, into the capsule and the capsule is then tightly sealed with the closure-piston element 27 by driving the latter home to the position shown in FIG. 2. The head 28 with ring 31 cooperate with top 29 to provide an effective seal and if desirable and the material properties permit, there may be heat sealing. The sealed capsule is then stored under liquid nitrogen or the like to maintain it in a frozen condition until ordered by the rancher or other user. Upon receipt of orders from the users the sealed capsule containing the correct amount of semen for one injection is transported to the point of use under the same temperature conditions. At the time of impregnation the temperature of the semen is raised to about ambient. The severable capsule and connector 34 are severed by a transverse cut as shown at A—A in FIG. 2 and the capsule snap-fitted over the depending end 11 of actuator 8 all as explained. It should be noted that by virtue of piston 30 and sealing rings 36 the semen has remained in its sealed condition from the time of original sealing in the capsule to this point. The capsule is now cut at B—B to open to atmosphere aperture 23. The actuator with the attached capsule is immediately inserted into the vagina of the animal and the fluid injected through the cervix into the vicinity of the uterus to complete the artificial insemination procedure. By the above described method semen is stored in and ejected from the same vehicle and remains completely sealed from the time of packaging until ejection. Upon withdrawal of the applicator the capsule is removed and discarded. In this connection it should be mentioned that the barbs 18 in cooperation with ring 22 insures removal of the capsule from the genital tract of the animal. The outside of the body 9 of actuator 8 can be sterilized merely by dipping into disinfectant solution and another sealed capsule applied to the end of the body 9 and the operation repeated indefinitely without discarding of the actuator 8 or any necessity for further cleaning of it.

It is to be noted that the structure of the applicator and the method of its operation is such that no internal parts thereof are ever exposed to any contaminating environment so that there is never any necessity for cleaning and sterilizing the interior parts of the applicator apparatus. As should be clear, the actuator elements do not come in contact with any fluid 25.

It is an advantage of the invention that it provides a method and apparatus for the simple and effective impregnation of animals by artificial insemination which permits simple storage, shipping and usage techniques providing at all times for preservation of expensive semen which is available in limited quantities. The invention provides for maintenance of semen in a sterile sealed condition from the time of packaging until use without exposure to the atmosphere and attendant possibilities of contamination. It makes possible the storage in and ejection from the same capsule of the precise required amount of semen for impregnation with the elimination of any waste thereof resulting in a great saving in sperm and expense. The apparatus provides a maximum degree of sanitation in that no internal parts thereof are exposed to contamination during use with the result that dismantling and sterilization of internal parts is not necessary for reuse of the syringe. The construction of the device as respects the disposable piston which is not attached to the rod 14 is such that the problem of a sticking piston is eliminated and there is no chance for back flow of semen as there is no reciprocation during use. Additionally the apparatus is comparative3,256,884 ly simple, having no threaded mating parts, and its construction is readily adaptable to economic manufacturing procedure.

It is therefore to be understood that various modifications and changes may be made in the construction and arrangement of parts of the. present invention without departing from the spirit and scope thereof as defined by the appended claims.