WO2013094643A1

WO2013094643A1 - Subcutaneously implanted device for injecting drug solution

Info

Publication number: WO2013094643A1
Application number: PCT/JP2012/082948
Authority: WO
Inventors: 重義長尾; 之生廣田; 宗和西川
Original assignee: テルモ・クリニカルサプライ株式会社
Priority date: 2011-12-21
Filing date: 2012-12-19
Publication date: 2013-06-27

Abstract

A device (1) for injecting a drug solution is provided with an upper member (3), a bottom member (2), and a sealing member (4) that is accommodated therebetween. The upper member (3) is provided with: a main body (31) for accommodating the sealing member (4) in such a manner that the central section thereof is exposed; side bulges (34, 35) that are provided to both side sections; a rear end section (33) that is provided to a position opposite a discharge port (5); two upright side-surface sections (37,38) for gripping which are approximately upright surfaces formed between the rear end section and the side-section bulge sections so as to face one another, and which have a significant curvature in the vicinity of the side bulges; and a tubular section (36) that is formed between the upright side-surface sections and the top end of the upper member.

Description

Subcutaneous implantable drug injector

The present invention relates to a drug solution injector for injecting a drug solution into a patient's body, and more particularly to a subcutaneously implantable drug solution injector used for treatment such as chemotherapy.

In the treatment of cancer and the like, a chemical solution injection therapy in which a chemical solution is injected into the body is performed. In order to use such a drug injection therapy, a subcutaneous implantable drug injector is used. Examples of the chemical solution injector include, for example, Patent Document 1 (Japanese Patent Publication No. 4-10832, USP 4,929,236), Patent Document 2 (WO 2009/35582), and Patent Document 3 (Patent Document 3) proposed by the applicant of the present application. No. 2004-350937).
These chemical injection devices include a main body composed of a ring-shaped upper member and a bottom member, and a seal member (septum) housed in the main body in a state where the peripheral edge is pressed between the upper member and the bottom member. An inner space for injecting medicine is formed by the lower surface of the seal member (septum) and the inner surface of the main body, and the main body is provided with a flow path for outflow of the chemical liquid communicating with this space. The seal member (septum) is a rubber stopper and can be punctured a plurality of times with a drug injection needle.

Japanese Examined Patent Publication No. 4-10832 (USP 4,929,236) WO2009 / 35582 JP 2004-350937 A

In the thing of the said patent document 1, the whole side surface inclines, and in the thing of patent document 3, it has a thin peripheral part in the perimeter of a lower end, and a side surface turns into a curved surface connected with the upper surface of the peripheral part. Therefore, it is not always easy to grasp, and it is not easy to insert into an incision portion that becomes an embedded portion. 10 to 12 of Patent Document 2 have a substantially circular puncture portion appearance and a non-circular bottom surface shape, which makes it easy to recognize a drug injection device implanted under the skin. Yes. Furthermore, since the thing of patent document 2 does not have a thin peripheral part in a lower surface part, it is easy to hold | grip. However, in the thing of patent document 2, there is no change in the shape of a side part, and it is difficult to recognize a puncture site | part (upper surface part of a septum) in the state which hold | gripped the side part, and the ring of the upper part of a chemical | medical solution injection tool It was necessary to grasp and confirm the shaped part.

The object of the present invention is that the side of the drug solution injector can be easily grasped, the drug solution injector is handled well in the subcutaneous implantation procedure, and it can be easily inserted into the incision, thereby facilitating the implantation procedure. In addition, it is easy to recognize the central part of the seal member (septum) by grasping the side part of the drug injection device implanted under the skin, and the puncture operation of the drug injection needle is quickly performed. It is intended to provide a subcutaneously implantable drug solution injector (access port) that can be used.

What achieves the above object is as follows.
An injection tool main body comprising a ring-shaped upper member and a bottom member closing the bottom surface of the upper member; and being accommodated between the upper member and the bottom member, closing an opening of the upper member; and the injection tool A subcutaneously implantable chemical solution injector comprising a seal member that forms a chemical solution inflow space in the body and a discharge port that communicates with the chemical solution inflow space, wherein the ring-shaped upper member has a central portion of the seal member A main body portion that stores the seal member in an exposed state, an annular protrusion portion that protrudes inward from an upper opening portion of the main body portion, and presses a peripheral edge portion of the seal member, and both sides of a tip portion of the upper member A side bulging portion provided in a portion, a rear end portion which is provided at a position facing the discharge port and becomes thinner toward the rear end side, and formed between the rear end portion and the side bulging portion. Is almost upright One, subcutaneous implantable drug fluid injecting device comprising two gripping upright side portion opposite to largely curved at the side bulging portion around.

FIG. 1 is a perspective view of a chemical liquid injector of the present invention. FIG. 2 is a plan view of the chemical liquid injector of the present invention. FIG. 3 is a front view of the chemical solution injector shown in FIG. 4 is a cross-sectional view taken along line AA in FIG. 5 is a cross-sectional view taken along the line BB in FIG. FIG. 6 is a front view of a seal member (septum) used in the chemical liquid injector of the present invention. FIG. 7 is a bottom view of the sealing member shown in FIG. 8 is a cross-sectional view taken along the line CC of FIG. FIG. 9 is a plan view of a bottom member used in the chemical liquid injector of the present invention. 10 is a cross-sectional view taken along the line DD of FIG. FIG. 11 is an external view of the drug solution injector of the present invention with a catheter attached. FIG. 12 is a plan view of a drug solution injector according to another embodiment of the present invention. 13 is a cross-sectional view taken along the line EE of FIG. FIG. 14 is a bottom view of the chemical liquid injector shown in FIG.

The subcutaneously implantable drug solution injector of the present invention will be described with reference to the illustrated embodiment.
The subcutaneous implantable drug solution injector 1 of the present invention is accommodated between an upper body 3 and a bottom member 2, an infusion tool body composed of a ring-shaped upper member 3 and a bottom member 2 that closes the bottom surface of the upper member 3, A seal member 4 that closes the opening of the upper member 3 and forms a chemical solution inflow space 10 in the injection tool main body, and a discharge port 5 that communicates with the chemical solution inflow space 10 are provided.

The ring-shaped upper member 3 protrudes inward from the main body 31 that houses the seal member 4 in a state where the central portion of the seal member 4 is exposed, and the upper opening of the main body 31, and the peripheral portion of the seal member 4 is In order to press, it is provided at a position facing the annular projecting portion 32 and the discharge port 5, and the side bulge

portions

34 and 35 provided on both sides of the top end portion of the upper member 3, and thin toward the rear end side. A rear end portion 33 and two opposing grips formed between the rear end portion 33 and the side bulge

portions

34 and 35, which are substantially standing surfaces and are largely curved in the vicinity of the side bulge

portions

34 and 35. There are provided standing

side surface portions

37 and 38, and a cylindrical portion 36 formed between the standing

side surface portions

37 and 38 and the upper end of the upper member 3 and having a substantially cylindrical shape or a slightly reduced diameter toward the upper end direction.

The subcutaneous implantable drug injector 1 of this embodiment is composed of an injector main body and a seal member 4 as shown in FIGS. And the injection tool main body was attached to the bottom part 2 which has the recessed part which forms the chemical | medical solution inflow space 10, the ring-shaped upper member 3 with which the upper surface side of the bottom part 2 is mounted | worn, and the side part of the upper member 3 And a discharge port 5. The seal member 4 is disposed between the bottom member 2 and the upper member 3, and the flange portion 42 is clamped by the bottom member 2 and the upper member 3, so that the bottom member 2 and the upper member 3 are liquid-tight. It is sealed.

The ring-shaped upper member 3 includes a ring-shaped main body 31 that accommodates the seal member 4 in a state where the central portion of the seal member 4 is exposed, and an inner portion (center direction) of the opening from the upper opening of the main body 31. ) Projecting annular projection 32. The annular projecting portion 32 is for pressing the upper surface of the peripheral edge portion (flange portion) 42 of the seal member 4 at its lower surface. Further, in this embodiment, the annular protrusion 32 is formed on the inner edge side portion of the lower surface of the annular protrusion 32, protrudes downward, and has an annular inclined surface having an annular inclined surface whose inner diameter expands downward. 39 is provided. The annular edge portion 39 can be inserted into the upper surface of the flange portion of the seal member 4. The annular protrusion 32 has a seal member peripheral portion pressing portion 32 a formed on the outer side of the annular edge portion 39 and having an annular and flat surface. The seal member peripheral edge pressing portion 32 a presses (compresses) the flange portion 42 of the seal member 4.

Furthermore, the upper member 3 has a rear end portion 33 that extends to the opposite side of the discharge port 5 from the outer edge of the annular protrusion at a position facing the discharge port 5. The rear end portion 33 becomes thinner toward the rear end side and has a width. In this embodiment, the rear end 33 has a crescent shape that is slightly collapsed, as shown in FIG.

Further, as shown in FIGS. 2, 3 and 5, the upper member 3 includes

side bulging portions

34 and 35 provided on both sides of the tip portion of the upper member 3. As shown in FIG. Further, the discharge port 5 is located between the

side bulging portions

34 and 35. Further, the upper member 3 is formed between the rear end portion 33 and the

side bulging portions

34 and 35 as shown in FIGS. In the vicinity of the bulging

portions

34 and 35, there are two standing

upright side portions

37 and 38 for gripping that are greatly curved as compared with other portions. The center of the seal member 4 is located between the two gripping standing

side surfaces

37 and 38 facing each other. Further, in this embodiment, the central portion of the seal member 4 is located between the portions that are largely curved in the vicinity of the

side bulging portions

34 and 35 of the two opposing standing

side surfaces

37 and 38 for gripping. Yes.

Further, as shown in FIGS. 1 and 3, the standing

side surface portions

37 and 38 extend from the rear end portion 33 toward the

side bulging portions

34 and 35, and the height of the standing side surface portion gradually increases. The height is higher, and the vicinity of the central side portion of the annular projecting portion 32 is the highest, and rapidly decreases toward the

side bulging portions

34 and 35. As described above, since the gripping standing

side surface portions

37 and 38 are the highest in the vicinity of the central side portion of the annular projecting portion 32, the central side portion of the annular projecting portion 32 can be easily gripped. Furthermore, when grasping, the fingertip feels a portion that is largely curved in the vicinity of the

side bulging portions

34 and 35, so that the central portion of the annular protrusion 32 (in other words, the central portion of the seal member 4) is between the gripping portions. You can easily recognize that there is. Providing such standing side surfaces 37 and 38 for gripping facilitates the puncturing operation of the drug injection needle after being implanted subcutaneously, and facilitates handling in the subcutaneous implantation procedure.

Furthermore, the upper member 3 includes standing

side surface portions

37 and 38 and a cylindrical portion 36 formed between the upper ends of the upper member 3 and having a substantially cylindrical shape or a diameter that is slightly reduced toward the upper end direction. In this embodiment, as shown in FIG. 3, the cylindrical portion 36 is gradually reduced in diameter toward the upper side. By having this cylindrical portion 36, the cylindrical portion 36 (in other words, the central portion of the annular projecting portion 32 and the central portion of the seal member 4) from the skin surface can be recognized after being subcutaneously embedded. In addition, since the cylindrical portion 36 is provided, it is easy to grip the upper portion of the drug solution injector 1 and the seal portion can be easily recognized and reliably gripped by the upper portion. The puncture operation of the injection needle can be performed quickly.
Further, as shown in FIGS. 1 to 3 and 5, the

side bulging portions

34, 35 become thinner toward the ends of the

side bulging portions

34, 35 and penetrate from the upper surface to the lower surface. A through-hole is provided, and

elastic members

8 and 9 that can be pierced by a suture needle are embedded in the through-hole, and the

side bulging portions

34 and 35 are sewn portions to a living body. The

elastic members

8 and 9 are made of an elastic material.
As the material for forming the

elastic members

8 and 9, various rubbers such as silicone rubber, isoprene rubber and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene and soft vinyl chloride, or a combination of two or more of these Of these, silicone rubber that is inert to the living body and has relatively little change in physical properties is particularly preferable.

As shown in FIG. 2, the bottom surface form of the upper member in this embodiment is a semi-elliptical shape in which both sides of the proximal end swell, and the upper surface is centered on the proximal end side of the bottom surface form. It has a round shape.
As shown in FIGS. 3, 5, 9, and 10, the bottom member 2 includes a bottom plate portion 21, an annular wall portion 22 that protrudes from the bottom plate portion 21, and a rear end portion 23. The annular wall portion 22 is substantially cylindrical and includes a recess 26 for forming the chemical solution inflow space 10 therein. Further, the annular wall portion 22 includes a discharge port mounting portion 24 that communicates with the concave portion 26 at a lower portion of the side surface. The discharge port mounting portion 24 is a cylindrical portion that protrudes from the annular wall portion 22 of the bottom member 2, and includes a lumen portion into which the proximal end portion of the discharge port 5 can be inserted. As shown in FIG. 9, the bottom plate portion 21 has a semi-elliptical shape in which both sides of the base end are cut off, and the annular wall portion is provided at a position whose center is based on the base end side of the bottom surface form. ing.

Further, in this embodiment, the bottom member 2 has a seal member peripheral portion pressing portion 22 a formed by the outer edge side portion of the upper surface of the annular wall portion 22. Further, an annular edge formed on an inner edge side portion (in other words, inside the seal member peripheral edge pressing portion 22a) on the upper surface of the annular wall portion 22 and having an annular inclined surface that protrudes upward and whose inner diameter increases upward. The unit 25 is provided. The annular edge portion 25 can be inserted into the lower surface of the flange portion 42 of the seal member 4.
The seal member 4 has a cylindrical main body 41 and an annular flange 42 formed on the peripheral edge of the main body 41 so as to protrude from the main body. The flange portion 42 is a portion to be pressed by the lower surface of the annular projecting portion 32 of the upper member 3 and the upper surface of the annular wall portion 22 of the lower member. Further, the seal member 4 of this embodiment is formed below the flange portion 42, has an outer diameter smaller than that of the flange portion, and a bottom member insertion portion 41b that is substantially equal to the inner diameter of the annular wall portion described above, and the flange portion. The upper member insertion portion 41a is formed above 42, has an outer diameter smaller than that of the flange portion, and is substantially equal to or slightly smaller than the inner diameter of the annular protrusion of the upper member 3 described above.

Furthermore, the seal member 4 is provided with a skirt-like protrusion 43 that is formed on the peripheral edge of the lower surface 44 of the bottom member inner insertion portion 41b and becomes thinner toward the end. The upper member insert portion 41a of the seal member 4 is inserted into the opening of the upper member 3, and its upper end protrudes from the upper surface of the upper member 3 as shown in FIGS. Further, the bottom member internal insertion portion 41b of the seal member 4 is accommodated and entered into the annular wall portion 22 of the bottom member 2 as shown in FIGS. And the chemical | medical solution inflow space 10 is formed between the lower surface 44 of the bottom part member insertion part 41b of the sealing member 4, and the inner surface of the recessed part 26 of the bottom member 2. FIG.

As a material for forming the injection tool main body (bottom member 2, upper member 3), a material having chemical resistance and biocompatibility is preferable, and polysulfone, polyethersulfone, epoxy resin, polyacetal and the like are used.
The seal member 4 can be pierced by a needle for injecting a chemical liquid, and the piercing portion is sealed after the needle for injecting a chemical liquid is removed. The seal member 4 is made of an elastic material. As a material for forming the seal member 4, various rubbers such as silicone rubber, isoprene rubber and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft vinyl chloride, or a combination of two or more of these may be used. Among them, particularly preferred is silicone rubber which is inert to the living body and has relatively little change in physical properties.

In this embodiment, as shown in FIGS. 6 to 8, the sealing member 4 is such that the upper surface side 42 a of the flange portion 42 is pressed by the annular protrusion 32 of the upper member 3, and the lower surface side of the flange portion 42. The outer edge portion of 42 b is pressed by the seal member peripheral portion pressing portion 22 a on the upper surface of the annular wall portion 22 of the bottom member 2, and the annular portion of the annular wall portion 22 of the bottom member 2 is connected to the inner edge portion on the lower surface side of the flange portion 42. Edge portion 25 is inserted. For this reason, the seal member 4 is compressed between the upper member 3 and the bottom member 2 (specifically, pressed by the seal member peripheral portion pressing portion 22a of the bottom member 2 and the seal member peripheral portion pressing portion 32a of the upper member 3). Compression) and the insertion of the annular edge portion 25 of the bottom member 2 is deformed, and the skirt-like projecting portion 43 of the seal member 4 is reduced, and the lower end outer peripheral surface of the bottom member insertion portion 41b is the annular shape of the bottom member 2 The wall 22 is in close contact with the inner surface. Further, in this embodiment, the outer edge portion on the upper surface side of the flange portion 42 is pressed by the seal member peripheral portion pressing portion 32a on the lower surface of the annular projecting portion 32 of the upper member 3, and the inner edge on the upper surface side of the flange portion 42. An annular edge 39 of the annular protrusion 32 of the upper member 3 is inserted into the part.

Further, in this embodiment, the seal member 4 is formed by the compression between the upper member 3 and the bottom member 2 and the deformation due to the insertion of the annular edge portion 25 of the bottom member 2 so that the skirt-like protrusion 43 of the seal member 4 is formed. Has almost disappeared. Further, due to the above deformation, the bottom portion of the bottom member insertion portion 41b of the seal member 4 has a slightly depressed central portion.
In the chemical solution injector 1 of this embodiment, the chemical solution inflow space 10 has a predetermined height formed by the inner surface of the seal member 4 and the inner surface of the recess 26 (the inner surface of the annular wall portion 22 and the upper surface of the bottom plate portion 21). It is a cylindrical space having a thickness.

Furthermore, as shown in FIGS. 1 to 5, a discharge port 5 is attached to the chemical solution injector 1 of this embodiment. The discharge port 5 is a cylindrical body, and includes a catheter proximal end mounting portion 53 provided on the distal end side, a bottom member mounting portion 52 provided on the proximal end side, and a flow passage 51 provided inside. I have. The proximal end opening 50 is the proximal end of the flow passage 51 and is located at the proximal end of the bottom member mounting portion 24.
An annular protrusion for preventing the catheter from coming off is provided on the outer surface of the catheter proximal end mounting portion 53. The bottom member mounting portion 52 is inserted into the discharge port mounting portion 24 of the bottom member 2 and is liquid-tightly fixed.
As the forming member of the discharge port 5, titanium, titanium alloy, stainless steel, or the like can be used, and titanium or titanium alloy is particularly preferable.

Moreover, the catheter 7 and the protector 6 as shown in FIG. 11 are connected to the chemical injection device 1 of the present invention when in use. The proximal end portion 71 of the catheter 7 is attached to the discharge port 5 so as to encapsulate the catheter proximal end attachment portion 53, and the protector 6 is attached to the proximal end portion of the catheter 7 attached to the catheter proximal end attachment portion 53. 71 is fitted and pressed to prevent the catheter from being detached. As the catheter 7, a catheter that can be inserted into the body (specifically, blood vessels (veins or arteries), bile ducts, vasculature and other vessels, epidural, subarachnoid, abdominal cavity) is used.

The catheter 7 is a tube body having a distal end side opening and an internal lumen, and has the same outer diameter and the same inner diameter throughout the entire body. The outer diameter of the catheter is preferably 0.3 to 5 mm, and particularly preferably 0.9 to 2.8 mm. The inner diameter of the catheter is preferably 0.1 to 2.6 mm, particularly preferably 0.6 to 1.8 mm.
The catheter 7 is flexible and preferably has some elasticity. Examples of the catheter forming material include olefin-based elastomers (for example, polyethylene elastomers and polypropylene elastomers), polyesters such as polyethylene terephthalate, soft polyvinyl chloride, polyurethane and urethane-based elastomers, polyamides and amide-based elastomers (for example, polyamide elastomers). And a flexible polymer material such as a fluororesin elastomer, an ethylene-vinyl acetate copolymer, and silicone rubber.

Further, the drug injection device of the present invention may have an X-ray contrast function like the drug injection device 1a shown in FIGS.
FIG. 12 is a plan view of a chemical liquid injector 1a according to another embodiment of the present invention. 13 is a cross-sectional view taken along the line EE of FIG. FIG. 14 is a bottom view of the chemical liquid injector shown in FIG.
The subcutaneous implantable drug injector 1a of this embodiment is similar to the subcutaneous implantable drug injector 1 described above, and includes an injector main body comprising a ring-shaped upper member 3 and a bottom member 2 that closes the bottom surface of the upper member 3. And a seal member 4 that is housed between the upper member 3 and the bottom member 2, closes the opening of the upper member 3, and forms the chemical solution inflow space 10 in the injection tool body, and a discharge that communicates with the chemical solution inflow space 10. Port 5. In addition, a ring-shaped contrast member 15 is provided in the injection tool main body, specifically, in a gap formed between the ring-shaped upper member 3 and the bottom member 2. The contrast member 15 has an X-ray contrast function. The ring-shaped upper member 3, the bottom member 2, the seal member 4 and the discharge port 5 are the same as described above.

In the chemical injection device 1a of this embodiment, the contrast member 15 is a thin plate ring-shaped member having a defect on the discharge port 5 side. Specifically, as shown in FIGS. 12 to 14, the contrast member 15 has a substantially elliptic outer edge and a substantially perfect inner edge as shown in FIG. It has a part. The contrast member 15 surrounds the outer periphery of the lower portion of the annular wall portion 22 from which the bottom member 2 protrudes, and the seal member 4 is located above the central portion. Therefore, it is possible to confirm the seal member 4 (punctureable portion) by X-ray contrast. Furthermore, the chemical | medical solution injection tool 1a of this invention is provided with the rear-end part 33 which becomes thin toward the rear-end side. In order to correspond to this shape, the contrast member 15 has a wide central portion on the rear side. For this reason, the position of the rear end part of the chemical liquid injector 1a, that is, the indwelling state of the chemical liquid injector 1a can be confirmed by X-ray contrast. In particular, the contrast member 15 of this embodiment gradually increases in width from both sides toward the rear center, and is widest at the center. In addition, the central portion on the wide rear side faces the missing portion (discharge port 5).

In this chemical solution injector 1a, the contrast member 15 is a thin plate ring-shaped member having a defect on the discharge port 5 side. It is merely housed in a gap formed between the ring-shaped upper member 3 and the bottom member 2, but is not limited to this, for example, embedded in the upper surface of the bottom member 2 It may be embedded in the lower surface of the bottom member or embedded in the bottom surface of the upper member.
Furthermore, in the chemical solution injector 1a of this embodiment, the contrast member 15 has an inversion recognition function. Specifically, the contrast member 15 includes a left-right asymmetric cutout portion 15a formed in a wide portion. The cutout portion 15a has a “C” shape in this embodiment. In a normal indwelling configuration in which the seal member 4 (punctureable portion) is located on the upper side, the letter “C” can be recognized as shown in FIG. Then, in a state where the contrast member 15 is reversed and the seal member 4 (punctureable portion) is located on the lower side, as shown in the rear view of FIG. 14, a left-right asymmetric mark (“C” in this embodiment) Is reversed and the character “C” cannot be recognized. Therefore, by providing such a reversal recognition function 15a, it is possible to confirm reversal (inversion) of the pharmaceutical injection device 1a by X-ray contrast.

As the forming member of the contrast member 15, a metal plate having a high X-ray contrast metal plating such as gold, platinum, tungsten, titanium, titanium alloy, stainless steel, gold, platinum, or the like, a contrast material (gold, platinum, tungsten) A resin plate to which a metal powder such as barium sulfate or contrast medium such as bismuth carbonate is added) can be used. In particular, a metal plate made of gold, platinum, tungsten, titanium, or a titanium alloy, or a metal plate having gold or platinum plating is preferable.

The subcutaneous implantable drug solution injector of the present invention is as follows.
(1) An injection tool body composed of a ring-shaped upper member and a bottom member that closes the bottom surface of the upper member, and is housed between the upper member and the bottom member, closes the opening of the upper member, and A subcutaneously implantable drug solution injector comprising a seal member that forms a drug solution inflow space in the injection device main body, and a discharge port that communicates with the drug solution inflow space,
The ring-shaped upper member protrudes inward from a main body portion that houses the seal member in a state where the central portion of the seal member is exposed, and presses a peripheral edge portion of the seal member An annular protrusion, side bulges provided on both sides of the tip of the upper member, and a rear end provided at a position facing the discharge port and becoming thinner toward the rear end. The subcutaneous implantable drug solution is formed between the rear end portion and the side bulging portion, and has two standing standing side surfaces for gripping which are substantially standing surfaces and are largely curved in the vicinity of the side bulging portions. Infusion tool.
In particular, the gripping standing side surface portion is greatly curved in the vicinity of the side bulge portion, and the seal portion is located between the two gripping standing side surface portions. For this reason, by grasping the two standing side surfaces for grasping, the chemical liquid injector can be easily grasped, and the curved portion is recognized, so that the position of the seal member can be reliably recognized. Therefore, it is easy to recognize the central part of the seal member (septum) by grasping the side part of the drug solution injector implanted under the skin, and the puncture operation of the drug injection needle can be performed quickly. Moreover, since it has the rear-end part which becomes thin toward the rear-end side, and the side part bulging part provided in the both sides of the front-end | tip part of an upper member is two standing side parts for holding | grip The insertion of the drug solution injector into the incision formed in the embedded portion and the handling of the drug solution injector in the subcutaneous implant procedure are good, and the implant procedure can be performed easily.

And as an embodiment of the present invention, the following may be sufficient.
(2) The ring-shaped upper member is provided with a cylindrical portion formed between the standing side surface portion and the upper end of the upper member, or a cylindrical portion that is slightly reduced in diameter toward the upper end. The subcutaneously implantable drug solution injector described in 1.
(3) The subcutaneously implantable drug solution injector according to (1) or (2) above, wherein the center of the seal member is positioned between the two standing gripping side surfaces.
(4) The subcutaneously implantable mold according to any one of (1) to (3), wherein a central portion of the seal member is positioned between the two curved standing rising side portions in the vicinity of the largely curved portion. Chemical injection tool.
(5) The height of the holding side surface portion for gripping is the highest in the vicinity of the side portion of the center portion of the annular projecting portion. The subcutaneous implantable drug solution according to any one of (1) to (4) above Infusion tool.
(6) The side bulge portion is thinner toward the end of the side bulge portion, and includes a through hole penetrating from the upper surface to the lower surface, and an elastic member embedded in the through hole. The subcutaneously implantable drug solution injector according to any one of (1) to (5) above.
(7) The bottom member includes a bottom plate portion and an annular wall portion that protrudes from the bottom plate portion, and the seal member is formed at a peripheral portion of the main body portion and the main body portion, The subcutaneously implantable drug solution injector according to any one of (1) to (6), further comprising a lower surface of the annular protrusion and a flange portion to be pressed by the upper surface of the annular wall portion of the bottom member.
(8) The bottom member is formed on a seal member peripheral portion pressing portion formed by an outer edge side portion of the upper surface of the annular wall portion and an inner edge side portion of the upper surface of the annular wall portion, and protrudes upward, and has an inner diameter. The subcutaneously implantable drug solution injector according to the above (7), which has an annular inclined surface that expands in diameter upward and includes an annular edge portion that can be inserted into the seal member.
(9) The upper member is formed on an inner edge side portion of the lower surface of the annular projecting portion, has an annular inclined surface that projects downward and has an inner diameter that expands downward, and can be inserted into the seal member. The subcutaneously implantable drug solution injector according to any one of (1) to (8), further including an annular edge portion and a seal member peripheral edge pressing portion formed outside the annular edge portion.
(10) The subcutaneous implantable drug solution injector includes a contrast member disposed in the injector body, and the contrast member is a ring-shaped member having a defect, and a central portion on the rear side. The subcutaneous implantable drug solution injector according to any one of the above (1) to (9), wherein the width of the drug is wide.
(11) The contrast-implanting member according to (9), wherein the contrast member has a left-right asymmetric cutout.

Claims

An injection tool main body comprising a ring-shaped upper member and a bottom member closing the bottom surface of the upper member; and being accommodated between the upper member and the bottom member, closing an opening of the upper member; and the injection tool A subcutaneously implantable drug solution injector comprising a seal member that forms a drug solution inflow space in the body and a discharge port that communicates with the drug solution inflow space,
The ring-shaped upper member protrudes inward from a main body portion that houses the seal member in a state where the central portion of the seal member is exposed, and presses a peripheral edge portion of the seal member An annular protrusion, side bulges provided on both sides of the tip of the upper member, and a rear end provided at a position facing the discharge port and becoming thinner toward the rear end. And two standing rising side portions for gripping that are formed between the rear end portion and the side bulging portion and are substantially standing surfaces and are largely curved in the vicinity of the side bulging portion. Subcutaneous implantable drug injector.
2. The subcutaneous part according to claim 1, wherein the ring-shaped upper member includes a substantially cylindrical shape or a cylindrical portion that is formed between the standing side surface portion and the upper end of the upper member and that is slightly reduced in diameter toward the upper end. Implantable chemical solution injector.
The subcutaneously implantable drug solution injector according to claim 1 or 2, wherein a center of the seal member is located between the two standing side surfaces for gripping.
The subcutaneously implantable drug solution injector according to any one of claims 1 to 3, wherein a central portion of the seal member is located between the two curved rising side portions facing each other in the vicinity of the largely curved portion.
The subcutaneously implantable drug solution injector according to any one of claims 1 to 4, wherein the height of the holding side surface portion for gripping is highest in the vicinity of the central side portion of the annular protrusion.
The side bulge portion is provided with a through-hole penetrating from the upper surface to the lower surface and an elastic member embedded in the through-hole while being thinner toward an end portion of the side bulge portion. The subcutaneously implantable drug solution injector according to any one of claims 1 to 5.
The bottom member includes a bottom plate portion and an annular wall portion protruding from the bottom plate portion, and the seal member is formed on a main body portion and a peripheral edge portion of the main body portion, and the annular protrusion portion of the upper member. The subcutaneously implantable drug solution injector according to any one of claims 1 to 6, further comprising: a lower surface of the bottom member and a flange portion to be pressed by the upper surface of the annular wall portion of the bottom member.
The bottom member is formed on a seal member peripheral edge pressing portion formed by an outer edge side portion of the upper surface of the annular wall portion and an inner edge side portion of the upper surface of the annular wall portion, and protrudes upward, and the inner diameter faces upward. The subcutaneously implantable drug solution injector according to claim 7, further comprising an annular edge portion that has an annular inclined surface that expands in diameter and can be inserted into the seal member.
The upper member is formed on an inner edge side portion of the lower surface of the annular protrusion, has an annular inclined surface that protrudes downward, and whose inner diameter expands downward, and can be inserted into the seal member The subcutaneously implantable drug solution injector according to claim 1, further comprising a sealing member peripheral portion pressing portion formed outside the annular edge portion.
The subcutaneous implantable drug solution injector includes a contrast member disposed in the injector body, and the contrast member is a ring-shaped member having a defect, and the width of the central portion on the rear side is The subcutaneously implantable drug solution injector according to any one of claims 1 to 9, which is wide.
The subcutaneously implantable drug solution injector according to claim 9, wherein the contrast member has a left-right asymmetric cutout.