CA1296231C - Device for administering solid preparations - Google Patents

Device for administering solid preparations

Info

Publication number
CA1296231C
CA1296231C CA 567616 CA567616A CA1296231C CA 1296231 C CA1296231 C CA 1296231C CA 567616 CA567616 CA 567616 CA 567616 A CA567616 A CA 567616A CA 1296231 C CA1296231 C CA 1296231C
Authority
CA
Grant status
Grant
Patent type
Prior art keywords
guide
member
barrel
needle
solid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA 567616
Other languages
French (fr)
Inventor
Keiji Fujioka
Nobuhiko Tamura
Yoshihiro Takada
Kenji Himeshima
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Pharmaceuticals Co Ltd
Nipro Corp
Original Assignee
Sumitomo Pharmaceuticals Co Ltd
Nipro Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Grant date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069Devices for implanting pellets, e.g. markers or solid medicaments

Abstract

Abstract of the Disclosure A device for administering solid or semisolid preparations in an organism subcutaneously comprises a barrel having a nozzle for attachment of a hollow needle.
A plunger is slidably arranged in the barrel and is used in combination with a guide member adapted to be snugly accommodated within the lumen of the barrel. The solid preparations are generally housed in the guide member and/or needle and are forced into the body subcutaneously through the needle.

Description

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Device for administerinq solid ~reparations This invention relates to a device for administering solid or semisolid preparations into subcutaneous layers of a patient.
In the past, subcutaneous implantation of solid preparations into the body has required surgery involving much labor, and has been accompanied by physical and mental suffering and, : occasionally, a surgi~al scar.
To avoid such problems some of the inventors have recently proposed a device for administering solid or semisolid preparations into the body through the s~in, as disclosed, for example in EP-A-139286 and Japanese patent applications laid-open Nos. 60-227772 published November 13, 1985; 60-129057 publish~d July 10, 1985; 61-79470 published April 23, 1986; and 61-82761 published April 26, 1986. Such a device generally comprises a hollow needle and a plunger slidably arranged in ~he needle, and enables the injection of solid or semisolid preparations into the subcutaneous layers of a patient without performing any surgical operation. However, such device makes it difficult to administer the preparations aseptically.
To solve this problem, the above inventors have proposed in EP-A~0255123 published February 3, 1988 (U.S. patent 4,900,304) use of a device for subcutaneous implantation of solid preparations that ,' ~ ~ .

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comprises a hollow barrel with a capsule chamber, a hollo~
needle attached to ~he tip of the barrel, and a plunge~
slidably arranged in the barrel. Such a device can be used in combination with capsules containing solid or semi-solid preparations. The preparations are first ejected from the capsule by the plunger and then injected into the subcutaneous layers through the needle. Such a device makes it possible to implant solid or semisolid preparations aseptically, but it also has some problems awaiting solution. For example, when loading the capsule into the barrel, the operator is required to focus his concentration on an opening of the capsule chamber because of its small diameter. In addition, this device requires care in preventing the plunger from bending or breaking, since the plunger is occasionally caught in the barrel.
It is therefore an object of the present invention to provide a device for administering solid or semisolid preparations into the body, which is simpler to handle and enahles the aseptic handling of solid or semisolid preparations during subcutaneous implantation.
Another object of the present invention is to provide a device for administering solid or semisolid preparations into the body, which makes it possible to administer solid or semisolid preparations into the subcutaneous layers easily and smoothly.
According to the present invention, there is provided a device for administering solid or semisolid preparations in an organism subcutaneously, comprising a barrel having a nozzle for attachment of a hollow needle, and a plunger slidably arranged in the barreI, said plunger comprising a plunger body slidable within said barrel, and an elongated, rod portion, connected to a forward end of the plunger body and having an outside diameter equal to or smaller than the inside diameter of said needle, the length of said rod portion being so desiyned that its tip will protrude for a 23~

certain distance beyond the tip of the needle when said plunger is forced into the barrel to the innermost position permitted by the barrel.
The device of the present invention can be used in combination with a guide member adapted to be contained within the barrel. The guide member is provided with a funnel-shaped guide hole to acilitate insertion of the rod portion of the plunger into the lumen of the needle.
The guide hole includes a tapered guide portion and an elongated straight portion extending from a small end of the tapered guide portion to the forward end of the guide member. The guide member is designed to have an outside diameter slightly smaller than the inner diameter of the barrel, although the size and configuration of the guide member may be varied to suit speci~ic requirements. The forward end of the guide member can be tapered to fit a tapered front inner wall of the barrel.
To ensure aseptic handling of the solid or semisolid preparations, it is preferred to use such a guide member as a capsule for solid or semisolid preparations. In this case, the guide hole of the guide member containing one or more such preparations is sealed by a film of a bio-compatible material at the forward end of the guide member and a cap at the opposite end to give a hermitically sealed encapsulation.
In a preferred embodiment of the present invention, there is provided a device for administering solid or semi-solid preparations in an organism subcutaneously, comprising a barrel having a nozzle for attachment of a hollow needle, a plunger slidably arranged in the barrel, and a guide member adapted to be snugly accommodated within a lumen of the barrel, said guide member having an outside diameter slightly smaller than the inside diameter of the barrel and being provided with a funnel-shaped guide hole~
said plunger comprising a plunger body of an outside , i, diameter equal to or slightly smaller than the inside diameter oE said barrel, and an elongated, rod portion of an outside diameter equal to or slightly smaller than the inside diameter of said needle, said rod portion being connected to a forward end of the plunger body and having a length equal to or slightly smaller than the distance rom the rear end of the guide member to ~he tip oE the needle. In this, the guide member is loaded into the barrel so that it comes into contact with the front inner wall o~ the barrel, and the rod portion of the plunger is designed to have a length corresponding to the distance from the needle point to the rear end of the guide member loaded in the barrel. Thus, when the plunger i5 forced into the barrel loaded with the guide member until the forward end of the slide portion of the plunger comes into contact with the rear end of the guide member, the tip of the rod portion of the plunger is stopped in the area within the edge portion of the needle.
In another preferred embodiment, the needle is provided with an air hole through which air in the barrel and the needle is discharge~ when the plunger is forced into the barrel. The needle may be attached to the tip of the barrel in any way. For example, if the needle is a cylindrical hollow tube with no hub, the needle is inserted into and ~ixed to the nozzle with adhesive. In this case, the needle is so designed that it has an outside diameter equal to the inside diameter of the nozzle. ~f the needle is provided at one end with a hub, the needle is attached to the barrel by inserting the nozzle o the barrel into the hub of the needle.
In the solid preparation administering equipment of the present invention, a guide member, containing at least one solid or semisolid preparations, is loaded into the barrel through the rear opening of the barrel and the preparations in the guide member are injected into the body through the .~ .

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hollow needle by forcing the plunger into the barrel until the forward end of the large-sized slide portion comes into contact with the rear end of the guide member The device of the present invention thus constitutes a solid S preparatisn injector.
The invention also relates to a yuide member for use in this equipment.
The invention will be further apparent Erom the follow-ing description taken in conjunction with the accompanying drawings which show, by way of example only, preferred embodiments thereof.
In the drawings:
Fig. 1 is a perspective view of a solid preparation injector embodying the present invention;
Fig. 2 is an exploded perspective view of the injector of Fig. l;
Fig. 3 is a sectional view of the injector of Fig. 1 with a guide member containing a solid preparation being loaded therein;
Fig. 4 is a section view of the injector of Fig. 1 in use;
Figs. 5 to 8 are cross sections showing various configurations of a guide member or capsule embodying the present invention; and Fig. 9 is a perspective view of the body of the guide member in Fig. 8 with a portion omitted.
Referring now to ~'igs. 1 and 2, there is shown a solid preparation injector 1 embodying the present invention, comprising three basic components, i.e., a barrel 3, a plunger 2 slidably arranged in the barrel 3, and a hollow needle 4 attached to a nozzle 5 at one end 3a of the barrel 3. At its other end the barrel 3 has a flange 11 which serves as a support when forcing the plunger into the barrel. The barrel 3 has a uniform inside diameter through its entire length except for the end 3a which is tapered inwardly. The tapered inner wall of the end 3a serves as a seat for a guide member 15 as explained below.

The material of the barrel can be chosen from glasses, metals and synthetic resins. It is, however, preferred to use a transparent material such as a glass or syntnetic resin. Suitable transparent synthetic resins include, without limitation, polypropylene~ polystylene, polymethyl pentene, and stylene-acrylonitrile copol~mers. Use of a transparent barrel makes it possible to observe the loaded condition of the guide member 15 and/or the condition of the solid preparation at the time of loading and administration.
The needle 4 is bevelled at its free end to ~orm a pointed tip, or an edge 10. The needle ~ is provided with an air hole 14 displaced from the edge lO to prevent air in the barrel from being injected into the body through the needle 4 when implanting solid preparations 16 into the body. The air hole 14 is generally formed at a distance of not less than 5 mm, preferably, 10 to 20 mm, from the edge 10 of the needle 4, so that the hole 14 will not enter the subcutaneous layers when the needle 4 has been inserted into such subcutaneous layers. The needle 4 is generally designed to be 0.5 to 3 mm in inside diameter and not less than 20 mm in length. The length of the needle varies with the scope of applications, but usually ranges from 25 to 60 mm. The needle 4 can be made of any material, provided that it is not corroded by chemicals and has a mechanical strength sufficient to prevent the needle from breaking or bending during insertion and withdrawal. It is, however, preferred to use stainless steel as the material for needle. The needle 4 is press-fitted into the nozzle 5 of the barrel 3 and is fixed thereto with an adhesive.
The plunger 2 is composed of a plunger body 6 and an elongated, small-diameter rod portion 7 connected at one end to the tip of the plunger body 6. The plunger body 6 has a cross-shaped section and is integrally molded with a flange 12. The plunger body 6 also includes a large-sized slide portion 8 that slidingly engages the inner wall of the barrel 3. The portion 8 is preferably provided with a ring-like gasket 13 of a rubberlike elastic material to allow the plunger body 6 to move smoothly. Materials for the ring-like gasket 6 include, without limitation, butyl rubber and silicone rubber. ~Iowever, if the needle 4 has no air hole, it is preferred that the plunger have no gasket and the portion 8 be provided with one or more axially extending grooves.
Materials that can be used for the body member 6 inc]ude glasses, metals and synthe~ic resins. It is preferred to use a synthetic resin such as polypropylene, polystylene or the like.
The portion 7 is a rodlike component, preferably of stainless steel, and is fixed to the tip oE the plunger body 6. This rod 7 is designed to have a diameter equal to or slightly smaller than the inner diameter of the needle 4. If there is no guide member 15 in the barrel, the length cf the rod 7 is such tha~ its tip 9, will protrude a certain distance beyond the edge 10 of the needle, when the plunger 6 is fully inserted, i.e. the portion 8 has bottomed on the tapered inner wall at the forward end of the barrel 3. When the plunger 2 is fitted in the barrel 3 with a guide member 15 in place and is then forced into the barrel 3 until the forward end of the portion 8 comes into contact with the rear end of the guide member 15, the tip 9 of the rod 7 is located in the area within the edge 10 of the needle 4, as shown in Fig. 4.
As noted previously, the solid preparation injector 1 is used in combination with the guide member 15. AS shown in Fig~ 5, the guide member 15 consists of a hollow body 15' with a funnel-shaped guide hole composed of a tapered guide portion 17 and an elongated straight portion Ihereinafter referred to as the lumen) 18 extending from the small end of the tapered guide portion 17 to the tip ' ~
~f 3~

of the guide member 15. The guide member lS has an outside diameter slightly smaller than the inner diameter of the barrel 3 and is tapered at its front part to make it fit the tapered inner wall of the barrel end 3a.
The guide member 15 can be produced in a variety o~
shapes, provided that it can be loaded into the lumen of the barrel 3 smoothly and fits into the end 3a of the barrel 3O For example, the guide member lS may decrease graduall~ in diameter so that it assumes an elliptical cone as shown in Fig. 7. Also, the guide member 15 can be provided in the outside wall of its main part (indicated by reference symbol d in Fig. 5) with several grooves, for example, four or eight grooves 15b extending in the direction parallel to the axis of the guide member 15 as shown in Figs. 8 and 9, or with a circular groove. If the front end of the barrel 3 is formed by a flat wall having a nozzle, the guide member is produced in the form of a cylinder having a guide hole. Further, the tapered guide portion 17 of the guide hole can be replaced by one formed as an elliptical paraboloid as shown in Fig. 7O
When the guide member 15 is used as a capsule for a solid or semisolid preparation, one or more solid or semi-solid preparations 16 are loaded into the lumen 18 of the guide member 15, which is then sealed by sealing means, i.e., a cap l9 and a sealing film 20, as shown in Fig. 6, to prevent the preparation 16 from discharging and to protect the same from contamination. The cap 19 is removably attached to the rear end of the guide member 15, while the film 20 is attached to the tip end of the guide member. This guide member or capsule 15 makes it possible to aseptically perform subcutaneous implantation of the preparation.
As the material for the guide member or capsule, there can be used any material that has no interaction with the preparations. It is, however, preferred to use a ,:
., ,, , transparent synthetic resin. Such transparent resins include, without limitation, polyethylene, polypropylene, polystylene, aclyronitrile-butadiene-stylene copol~mers and silicones.
The ~ap 19 is so shaped that it can be fitted onto the tapered guide portion 17 of the guide member 15 and engaged with the outside wall of the guide member 15 to prevent it from separation during transportation. As the material for the cap, there can be used any of the materials used for 10 the guide mem~er. It should be noted that the cap 19 is not necessarily made of the same material as the guide member 15.
The film 20 is of biocompatible material that meets the re~uirements to ensure aseptic protection of the solid 15 preparations and to be fractured easily by light force applied by the rod 7 of the plunger 2. Such a bio-compatible material includes, without limitation, gelatin, collagen, starch, cellulose, albumin, silicone and the like. Also, elastic materials such as natural rubbers, 20 silicone rubbers can be used as the material for the membrane, provided that the film has a cut in the form o~
a cross or asterisk.
The film 20 can be attached to the guide member 15, using a suitable adhesive or fixing member. If the guide 25 member 15 has no means for supporting the film 20 as shown in Fig. 6, it is preferred to fit the film 20 to the tip of the guide member with an adhesive. If the guide member 15 is provided with a projection 15a at its tip, as shown in Figs. 8 and 9, the film ~0 is sandwiched between this 30 tip and a hold-down ring 23 (not shown in Fig. 9) used as holding means.
For the solid or semisolid preparation 16 there is no specific limitation, but the preparation is generally composed of one or more active ingredients, or one or more 35 active ingredients and at least one component selected from the group of carriers and additives used as needed.

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As the active ingre~ients, there can be used any of the conventionally known active ingredients, which include, without limitation, interferon, interleukin, tumor necrosis factor, mitomycin, adriamycin, 5-fluorouracile, proistaglandin, prostacyclin, taspamin, hormones, hormone releasing factors. The carrier includes, without limitation, proteins such as collagen, gelatin, albumin biologically catabolic materials represented by synthetic polymers, such as polyglycolic acid, polylactic acid, polyglutamic acid; and silicones which are catabolic with the biological structure.
The solid preparation can be produced in a variety of shapes, ~or example, in the ~orm of a rod, needle, globule, disk or the like. For rod-shaped solid preparations, a preferred diameter ranges from 0.25 to 2.5 mm and the length is 3.0 to 50 mm. For globular solid preparations, a preferred diameter ranyes from 0.25 to 2.5 mm.
The injector 1 of the present invention can be used in combination with any of the guide members 15 shown in any one of Figs. 5 to 9 to allow the rod portion 7 of the plunger 2 to smoothly enter into the lumen of the needle memberO One or more solid preparations to be implanted into the subcutaneous layers of a patient is preferably contained in the guide capsule and/or the hollow needle member.
In use, the plunger 2 is irst removed from the barrel 1 and the guide member 15 is loaded into the barrel 3 with its tapered end leading. If the guide member 15 is a guide capsule containing the solid or semisolid preparation 16, as shown in Fig. 6, the guide member 15 is loaded into the barrel 3 after removal of the cap 19. The plunger 2 is then inserted into the lumen of the barrel 3 and is moved forwardly until the tip 9 of the rod 7 comes into contact with the guide member 15, as shown in Fig. 3~ At that time, the tapered front portion of the guide member 15 is 2~

in contact with the tapered inner wall of the barrel portion 3a.
The pointed end of the needle 4 is then stabbed into the subcutaneous layers B of the patient to be treated, and the plunger 2 is forced further into the ~arrel 3 until the tip end of the large-sized slide portion 8 comes into contact with the rear end of the guide capsule 15 (Fig. 4). During this step, the solid preparation 16 is pressed into the lumen of the needle 4 by the rod 7 and is implanted into the subcutaneous layers B of the patient.
When the forward end of the portion 8 of the plunger 2 comes into contact with the rear end of the guide member 15, the end 9 of the rod 7 of the plunger 2 is located in the area within the edge portion 10 of the needle 4, since the length of the rod 7 is determined in consideration of the lengths of the guide member 15, the nozzle 5 and the needle 4, and the distance between the forward end o~ the guide member 15 and the rear end of the needle 4. Thus, the solid preparation 16 is surely implanted in the sub-cutaneous layers without protrusion of the rod 7 beyond the edge 10 of the needle 4.
The combined use of the needle and guide member each containing the same or different solid preparations makes it possible to implant such solid preparations at one time.
As will be understood from the above, the device makes it possible to implant solid preparations into the sub-cutaneous layers of the patient certainly and smoothly and without causing extra damage to the organism. The combined use of the device and the guide member containing solid or semisolid preparations makes it possible to aseptically administer the preparations into the subcutaneous layers of the patient. Further, the combined use of the device, the needle containing a solid preparation and the guide capsule containing a solid preparation makes it possible to perform subcutaneous implantation of two or more :~2~

preparations which are the same or different from each other.
The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations, as might readily occur to those skilled in the art, are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications are intended to be included within the scope of the following claims.

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Claims (12)

1. A device for subcutaneously administering a solid or semisolid preparation in an organism, which comprises a solid preparation injector and a guide member containing one or more solid preparations and being loaded with said injector, said solid preparation injector comprising a needle member with a pointed end, a barrel having a nozzle for attachment of said needle member, and a plunger slidably arranged in said barrel, said barrel having a front and rear end and having a lumen tapered at said front end to provide a seat for said guide member, said plunger comprising a plunger body and an elongated small-sized rod portion being connected at one end to the tip of said plunger body, said small-sized rod portion having an outside diameter equal to or smaller than the inside diameter of said needle member with the length of said small-sized rod portion being determined such that said tip if said small-sized rod portion is stopped within said pointed end of said needle member when said plunger is forced into said barrel loaded with said guide member until said plunger stops, said guide member having an outside diameter slightly smaller than the inner diameter of said barrel and having a guide hole for guiding said small-sized rod portion in said lumen of said needle member, said solid preparations being contained in said guide hole of said guide member.
2. The device according to claim 1 wherein said needle is provided with an air hole for discharging air in the barrel and the needle.
3. The device according to claim 1 wherein said barrel is of a transparent synthetic resin.
4. The device according to claim 1 wherein the needle is a cylindrical hollow tube with no hub and has an outside diameter equal to the inside diameter of the nozzle of the barrel, and wherein the needle is being fixed in the nozzle of the barrel with adhesive.
5. The device according to claim 1 wherein the needle consists of a cylindrical hollow tube and a hub mounted on the base of the tube, said tube having an inside diameter equal to that of the nozzle of the barrel.
6. The device according to claim 1 wherein the guide member is tapered at its front part to fit within said seat.
7. The device according to claim 6 wherein the guide hole of the guide member is sealed by a cap removably mounted on the rear end of the guide member and a film of a biocompatible material fixed to the tip end of the guide member.
8. The device according to claim 1 wherein said guide hole of said guide member has an outside diameter slightly smaller than the inner diameter of said barrel, and wherein said guide hole includes a tapered guide way and an elongated straight hole extending from the small end of said tapered guide way to the tip of said guide member.
9. A device for subcutaneously administering a solid or semisolid preparation in an organism which comprises a hollow needle member, a barrel having a lumen and a nozzle for attachment of said needle member, a plunger slidably arranged in said barrel, and a guide member snugly accommodated within said lumen of said barrel and in contact with the front inner wall of said barrel, said plunger comprising a plunger body having an outside diameter equal to or slightly smaller than the inside diameter of said barrel and an elongated small-sized rod portion having an outside diameter equal to or slightly smaller than the inside diameter of said needle, said smaller rod portion being connected to the tip of said plunger and having a length equal to or slightly smaller than a distance from the rear end of said guide member to the tip of said needle member, said guide member having an outside diameter slightly smaller than the inside diameter of said barrel and being provided with a funnel-shaped guide hole to guide said small-sized rod portion of said plunger; said guide hole of said guide member containing at least one solid preparation.
10. A guide member for use in a device for subcutaneous implantation of a solid preparation comprising a hollow cylindrical barrel, a plunger slidably arranged in said barrel, and a hollow needle member attached to said barrel, said guide member comprising a cylindrical body with an outside diameter slightly smaller than the inner diameter of said barrel, and having a guide hole comprised of a tapered guide portion having a small end and an elongated straight portion extending from the small end of said tapered portion to the tip of said guide member, and wherein said guide member is tapered at its front part to fit within the tapered front inner wall of the barrel, and wherein said guide hole of said guide member is sealed by a cap removably mounted on the rear end of said guide member and a film of a biocompatible material fixed to the tip end of said guide member.
11. The guide member according to claim 10 wherein said guide member contains at least one of said preparation in said guide hole.
12. A device for subcutaneously administering a solid or semisolid preparation in an organism, comprising a hollow needle member containing at least one solid preparation, a barrel having a lumen and a nozzle for attachment of said needle member, a plunger slidably arranged in said barrel, and a guide member snugly accommodated within said lumen of said barrel and to be in contact with the front inner wall of said barrel, said plunger comprising a plunger body having an outside diameter equal to or slightly smaller than the inside diameter of said barrel and an elongated small-sized rod portion having an outside diameter equal to or slightly smaller than the inside diameter of said needle, said small-sized rod portion being connected to the tip of the plunger body and having a length equal to or slightly smaller than a distance from the rear end of said guide member to the tip of said needle member.
CA 567616 1987-05-26 1988-05-25 Device for administering solid preparations Expired - Fee Related CA1296231C (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JPUM79259/1987 1987-05-26
JP7925987U JPH0342937Y2 (en) 1987-05-26 1987-05-26
JP129439/1987 1987-05-26
JP12943987A JPH0586238B2 (en) 1987-05-26 1987-05-26

Publications (1)

Publication Number Publication Date
CA1296231C true CA1296231C (en) 1992-02-25

Family

ID=26420300

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 567616 Expired - Fee Related CA1296231C (en) 1987-05-26 1988-05-25 Device for administering solid preparations

Country Status (6)

Country Link
US (1) US4950234A (en)
EP (1) EP0292936B1 (en)
KR (1) KR950008520B1 (en)
CA (1) CA1296231C (en)
DE (2) DE3855054D1 (en)
ES (1) ES2086291T3 (en)

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ES2086291T3 (en) 1996-07-01 grant
DE3855054D1 (en) 1996-04-11 grant
DE3855054T2 (en) 1996-07-18 grant
KR950008520B1 (en) 1995-07-31 grant
US4950234A (en) 1990-08-21 grant
EP0292936B1 (en) 1996-03-06 grant
EP0292936A2 (en) 1988-11-30 application
EP0292936A3 (en) 1991-04-03 application

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