JP2010233838A - Medical instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical instrument excellent in tamperproof effects. <P>SOLUTION: A syringe 1 includes an outer cylinder 2 with a tubular port, a cap 7 installed on the port and opened by being turned around the port axis, and a film 5 that covers the cap 7 installed on the port and the outer cylinder 2 in a lump, and has a breaking part 6 that breaks when the cap 7 is opened. The breaking part 6 includes a plurality of first cut lines 61a, 61b intermittently formed along the circumference of the cap 7, a second cut line 62 extending in the direction of separating from the first cut line 61b with an inclination angle of 10 to 70° with the first cut line 61b, a third cut line 63 extending from the second cut line 62, and a fourth cut line 64 formed near the third cut line 63 apart from it. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical device.

  A prefilled syringe in which a liquid preparation is aseptically filled in a sterilized syringe outer cylinder (container) is known (for example, see Patent Document 1). The prefilled syringe is attached to a syringe outer cylinder having a mouth part from which the liquid preparation is discharged and a lock member (lock adapter) rotatably supported by the mouth part, and a mouth part of the syringe outer cylinder. A cap fixed by screwing; and a film that collectively covers the cap and the lock member in a mounted state in which the cap is mounted on the syringe outer cylinder.

  In the prefilled syringe described in Patent Document 1, a perforation (breaking portion) that is broken when the cap is opened (removed) from the attached syringe outer cylinder is formed in the film. The perforation includes a cut line 44 (first cut line) formed along the circumferential direction of the cap, and an inclined cut line 46 (second cut line) that is inclined with respect to the cut line 44 and intersects the predetermined cut line 44. (Note that the reference is quoted from Patent Document 1).

  When the film having such a perforation is opened by opening the cap and the perforation is broken, the broken perforation does not flutter up and becomes a clean break (see FIG. 11). Moreover, the broken state of this film is the same also on the syringe outer cylinder side from which the cap is removed.

  However, since the broken perforation is in a clean broken state, when the cap is attached again to the syringe outer cylinder from which the cap has been removed (when uncapped), the perforation is not yet broken. In some cases, the prefilled syringe may be mistakenly recognized as being unused (unopened). With prefilled syringes, once the cap is opened (opened), it is difficult to maintain the internal sterility for a long period of time, so it is necessary to use the liquid preparation quickly. There was a problem that it was used while misunderstanding that it was used.

JP 2008-67832 A

  An object of the present invention is to provide a medical device having excellent tamper-proof properties.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a medical device body having a tubular mouth;
A cap that is attached to the mouth and is opened by rotating around the axis of the mouth;
The cap and the medical device main body are collectively covered with the cap attached to the mouth portion, and a film having a fracture portion that is broken when the cap is opened,
The breaking portion includes a plurality of first cut lines formed intermittently along the circumferential direction of the cap;
A second score line extending in a direction away from all or part of the first score line with an inclination angle of 10 to 70 ° with respect to the first score line;
A third score line extending from the second score line;
A medical device comprising a fourth cut line formed apart from the third cut line in the vicinity of the third cut line.

  (2) The medical instrument according to (1), wherein the third cut line is formed in parallel to the first cut line or has a parallel part.

  (3) The medical instrument according to (1) or (2), wherein one end of the fourth cut line is at the same position as the third cut line with respect to the axial direction of the mouth.

  (4) The minimum separation distance between the third cut line and the fourth cut line is shorter than the length of either the third cut line or the fourth cut line. A medical device according to any one of the above.

  (5) The medical device according to any one of (1) to (4), wherein the second cut line is connected to one of the two adjacent first cut lines.

  (6) The medical device according to any one of (1) to (5), wherein the second cut line is connected to an end portion of the first cut line that is positioned forward of the cap in the rotation direction.

  (7) The medical instrument according to any one of (1) to (6), wherein the length of the second cut line is longer than the length of either the third cut line or the fourth cut line.

  (8) The medical device according to any one of (1) to (7), wherein the adjacent first cut lines have different lengths.

  Moreover, in the medical device of this invention, it is preferable that the said 4th cut line is formed in parallel with the said 3rd cut line, or has a parallel part.

  Moreover, in the medical device of this invention, it is preferable that the said 4th cut line inclines or has a part which inclines with respect to the said 3rd cut line.

  In the medical device of the present invention, it is preferable that the fourth cut line is inclined in the same direction as the second cut line.

Moreover, in the medical device of the present invention, the breaking portion is located at the boundary between the medical device body and the cap,
It is preferable that the third cut line and the fourth cut line are respectively disposed on the cap side with respect to the boundary portion.

  In the medical device of the present invention, it is preferable that the length of the fourth cut line is the same as or longer than the length of the third cut line.

  In the medical device of the present invention, it is preferable that the second cut line is connected to the shorter first cut line of the two first cut lines having different lengths.

In the medical device of the present invention, it is preferable that the second score line crosses the first score line and crosses the first score line.
Moreover, in the medical device of this invention, it is preferable that the said film has heat shrinkability.

Moreover, in the medical device of this invention, it is preferable that the said cap is discarded after opening.
The medical device of the present invention is preferably a prefilled syringe.

  According to the present invention, for example, when the medical device main body is gripped with the film with one hand and the cap is gripped with the film with the other hand and the cap is opened, the film is cut at the first cut line of the fracture portion. Divided into two. In addition, as the film is divided into two, for example, at the cap-side portion of the film divided into two, the third cut line and the fourth cut line that were separated before breaking are connected. As a result, the cap-side portion is connected from the first cut line to the fourth cut line (becomes one continuous cut), and thus has a shape in which a whirling has occurred (a petal-like shape). On the other hand, the portion of the film divided into two parts on the medical device main body side does not flutter, but is in a clean broken state.

  And even if the cap on which the cap-side portion having the pruning is arranged is remounted (recapped) on the medical device body, the puddle can be visually recognized, so that the recapped medical device (medical device) It can be easily confirmed that the main body is opened (used). Therefore, the medical device has an excellent tamper-proof property (the fact that it has once been in use can be confirmed later), and it is possible to reliably prevent the opened one from being used by mistake. .

It is a side view which shows 1st Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a decomposition | disassembly longitudinal cross-sectional view of the syringe outer cylinder and cap which the prefilled syringe shown in FIG. 1 has. FIG. 2 is an enlarged view of a region [A] surrounded by an alternate long and short dash line in FIG. 1. It is a side view (enlarged view of the fracture | rupture part of a film) which shows 2nd Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a side view (enlarged view of the fracture | rupture part of a film) which shows 3rd Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a side view (enlarged view of the fracture | rupture part of a film) which shows 4th Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a side view (enlarged view of the fracture | rupture part of a film) which shows 5th Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a side view (enlarged view of the fracture | rupture part of a film) which shows 6th Embodiment at the time of applying the medical device of this invention to a prefilled syringe. It is a perspective view (figure which shows the fracture state of a film) of a cap when the prefilled syringe shown in FIG. 1 is opened. It is a perspective view (figure which shows the fracture state of a film) of a syringe outer cylinder when the prefilled syringe shown in FIG. 1 is opened. It is a perspective view (figure which shows the fracture state of a film) of a cap when the conventional prefilled syringe is opened.

Hereinafter, the medical device of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.
<First Embodiment>
FIG. 1 is a side view showing a first embodiment when the medical device of the present invention is applied to a prefilled syringe, FIG. 2 is an exploded longitudinal sectional view of a syringe outer cylinder and a cap included in the prefilled syringe shown in FIG. 3 is an enlarged view of a region [A] surrounded by a one-dot chain line in FIG. 1. FIG. 9 is a perspective view of a cap when the prefilled syringe shown in FIG. ), FIG. 10 is a perspective view of the syringe outer cylinder when the prefilled syringe shown in FIG. 1 is opened (a view showing a broken state of the film). In the following, for convenience of explanation, the upper side in FIGS. 1 to 3, 9, and 10 (the same applies to FIGS. 4 to 8 and 11) is referred to as “tip”, and the lower side is referred to as “base end”. To tell.

  A prefilled syringe (hereinafter simply referred to as “syringe”) (medical device) 1 shown in FIG. 1 is obtained by preliminarily storing (filling) a liquid preparation 200 such as a chemical solution in the syringe 1. The syringe 1 includes a syringe outer cylinder (hereinafter simply referred to as an “outer cylinder”) (medical device body) 2, a gasket 3 that can slide in the outer cylinder 2, and a pusher (plunger) that moves the gasket 3. ) 4, a cap 7 attached to the outer cylinder 2, and a film 5 that collectively covers the cap 7 and the outer cylinder 2 (lock adapter 23) when the cap 7 is attached to the outer cylinder 2. It is configured.

  The liquid preparation 200 is not particularly limited. For example, blood preparations, saccharide injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, vaccines, antibiotic injection solutions, and contrast media Agents, steroids, proteolytic enzyme inhibitors, fat emulsions, various protein preparations, anticancer agents, anesthetics, stimulants, various chemicals such as narcotics, various diagnostic agents, or distilled water, physiological saline, disinfectant, nutrition Liquids such as agents, liquid foods, and alcohols.

The outer cylinder 2 is composed of a bottomed cylindrical member having a bottom portion 211.
A plate-like flange 25 is integrally formed on the outer periphery of the base end of the outer cylinder 2. When the pusher 4 is moved relative to the outer cylinder 2, the operation can be performed by placing a finger on the flange 25.

  A central portion of the bottom portion 211 of the outer cylinder 2 is integrally formed with a mouth portion 22 that is reduced in diameter relative to the body portion (outer cylinder main body 21) of the outer cylinder 2 and protrudes into a tubular shape.

  As shown in FIG. 2, a flow path 221 through which the liquid preparation 200 can pass (can enter and exit) is formed inside the mouth portion 22, and communicates with the lumen portion (space 24) of the outer cylinder 2. .

  The distal end portion of the mouth portion 22 is provided with a male taper portion 222 whose outer diameter gradually decreases toward the distal end direction.

  A constant outer diameter portion 222 a having a constant outer diameter along the shaft 223 is formed on the proximal end side of the mouth portion 22 with respect to the male taper portion 222. A cylindrical lock adapter (connecting member) 23 is supported on the constant outer diameter portion 222a. In the present embodiment, the lock adapter 23 is provided so as to be capable of moving along the direction of the shaft 223 and rotating around the shaft 223, but it may not be displaced. A female screw 232 is formed on the inner peripheral portion of the lock adapter 23.

  Further, a reduced diameter portion 235 whose inner diameter is reduced is formed at the proximal end portion of the lock adapter 23. By fitting the reduced diameter portion 235 into the constant outer diameter portion 222a of the mouth portion 22, the lock adapter 23 is reliably supported by the mouth portion 22 of the outer cylinder 2 (see FIG. 2).

  As shown in FIG. 10, the outer shape of the cross section of the lock adapter 23 is preferably a hexagon. Thereby, it is possible to easily perform the removal operation (screwing release operation) when the lock adapter 23 is gripped and the cap 7 is removed from the lock adapter 23.

  As a constituent material of the outer cylinder 2 (including the lock adapter 23) and a pusher 4 described later, for example, polyvinyl chloride, polyethylene, polypropylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic Resin, polyester such as acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), cyclic polyolefin, etc. Various resins.

  In addition, it is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.

  Further, a scale (not shown) is preferably formed on the outer peripheral surface of the outer cylinder 2. Thereby, the liquid quantity of the liquid formulation 200 accommodated in the syringe 1 can be grasped | ascertained.

  As shown in FIG. 1, a gasket 3 made of an elastic material is accommodated in such an outer cylinder 2. Two ring-shaped protrusions 31 and 32 are formed on the outer peripheral portion of the gasket 3 at predetermined intervals along the axial direction. By sliding the protrusions 31 and 32 in close contact with the inner peripheral surface 20 of the outer cylinder 2, airtightness (liquid tightness) can be reliably maintained and slidability can be improved. .

  Further, the gasket 3 is formed with a hollow portion (not shown) that opens to the base end surface thereof. A head portion (not shown) of the pusher 4 is inserted (inserted) into the hollow portion.

  The constituent material of the gasket 3 is not particularly limited. For example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, Various rubber materials (especially those vulcanized) such as silicone rubber and fluoro rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluorine Various thermoplastic elastomers such as rubber and chlorinated polyethylene can be mentioned, and one or more of these can be used in combination.

The pusher 4 moves the gasket 3 in the outer cylinder 2 in the longitudinal direction.
The pusher 4 has a main body portion 40 mainly composed of a plate piece having a cross-shaped cross section, a plate member 41 at the distal end, a plate member 43 at the intermediate portion, and a flange at the proximal end. (Plate-like) finger contact portion 42 is formed integrally with main body portion 40. The pusher 4 is moved in the distal direction by pressing the finger rest 42 with a finger or the like.

  The flange 25 of the outer cylinder 2 is provided with a detachment preventing member 27 that comes into contact with the plate member 43 when the pusher 4 is moved in the proximal direction. In the detachment preventing member 27, when the pusher 4 is moved in the proximal direction, the surface 271 on the distal end side of the detachment preventing member 27 and the surface 431 on the proximal end side of the plate member 43 are within the space 24. It abuts and restricts the movement of the pusher 4. This prevents the gasket 3 and the pusher 4 from being detached from the outer cylinder 2.

  The cap 7 is attached to the mouth portion 22 of the outer cylinder 2 and seals the mouth portion 22 in the attached state. As shown in FIG. 2, the cap 7 includes a cap body 71 having a bottomed cylindrical shape, and a packing 76 inserted into the cap body 71.

  The cap body 71 can be divided into three parts. That is, the cap main body 71 can be divided into a grip portion 73, a hexagonal portion 72, and a screw portion 74 from the distal end side.

  The grip portion 73 is a portion that is gripped when the cap 7 is operated. By grasping the gripping portion 73 and rotating the cap 7 (screw portion 74) around the shaft 75, the cap 7 is screwed with the lock adapter 23 of the outer cylinder 2 or the screwing is released. Can be. In addition, a plurality of grooves 731 along the axis 75 direction are formed on the outer peripheral portion of the grip portion 73. Accordingly, it is possible to prevent a finger or the like from slipping unintentionally from the grip portion 73 when the cap 7 is rotated.

  The hexagonal portion 72 is a portion that is formed in the middle of the cap body 71 and whose outer cross-sectional shape forms a hexagon. The hexagonal size of the hexagonal portion 72 is substantially equal to the hexagonal size of the lock adapter 23 of the outer cylinder 2.

  The screw portion 74 is a portion where a male screw 741 is formed. In the mounted state, the male screw 741 of the screw portion 74 can be screwed with the female screw 232 of the lock adapter 23. As a result, the cap 7 is prevented from being unintentionally detached from the outer cylinder 2, so that the mounting state can be reliably maintained. Then, by rotating the cap 7 around the shaft 223 (shaft 75) in the direction of arrow B in FIG. 1, the cap 7 can be detached from the mouth 22, that is, can be opened. After opening, for example, an injection needle can be attached to the mouth portion 22.

  In addition, in the syringe 1, it is preferable not to recap once the cap 7 is opened. In order to prevent this recapping, the cap 7 is preferably discarded after being opened.

  Further, as shown in FIG. 2, a packing 76 is accommodated in the lumen portion 711 of the cap body 71. The packing 76 has a plate shape and is in contact with the bottom 712 of the cap body 71. In the mounted state, the mouth portion 22 of the outer cylinder 2 is inserted into the lumen portion 711 of the cap body 71, and the tip opening 224 of the mouth portion 22 is in close contact with the packing 76. Thereby, the mouth part 22 can be liquid-tightly sealed.

  Although it does not specifically limit as a constituent material of the cap main body 71, For example, the material quoted by description about the outer cylinder 2 can be used. Further, the constituent material of the packing 76 is not particularly limited, but for example, the materials mentioned in the description of the gasket 3 can be used.

  As shown in FIG. 1, in the mounted syringe 1, the lock adapter 23 and the cap 7 of the outer cylinder 2 are covered with a film 5. The film 5 is formed of, for example, a belt-like sheet material, and these members can be covered by winding the sheet material around the lock adapter 23 and the cap 7 together.

  In the present embodiment, the film 5 covers from the middle of the grip portion 73 of the cap 7 to the vicinity of the distal end side of the reduced diameter portion 235 of the lock adapter 23. Although the distance L1 from the front end surface 713 of the cap 7 (cap main body 71) to the front end edge 51 of the film 5 is not particularly limited, for example, it is preferably 1 mm or more, and more preferably 2 to 3 mm. Thereby, the cap 7 is not easily loosened, and it is easy to determine that the cap 7 is not used. Furthermore, it is possible to display characters, symbols, and the like that guide the correct opening operation of the cap 7 on the film 5.

  The constituent material of the film 5 is not particularly limited, but for example, a material having heat shrinkability is preferably used. Examples of such materials include polyesters such as polyvinyl chloride, polystyrene, polyethylene terephthalate and polybutylene terephthalate, polyolefins such as polyethylene and polypropylene, and polymer alloys containing these. By using such a heat-shrinkable material, the film 5 is deformed along the outer shape of the lock adapter 23 and the cap 7 when the film 5 is heat-shrinked. It can adhere. As a result, the cap 7 is prevented from rotating unintentionally and being detached, so that the mounting state can be more reliably maintained. In addition, it is preferable that the shrinkage rate of the film 5 is 5 to 10%. The film 5 may be a single layer or a laminate of a plurality of layers.

  The film 5 has a break portion 6 that is broken when the cap 7 is opened. This fracture | rupture part 6 is located in the boundary part 11 of the cap 7 and the lock adapter 23 of the outer cylinder 2 (refer FIG. 1, FIG. 3). When holding the lock adapter 23 of the outer cylinder 2 with the film 5 with one hand and holding the cap 7 (gripping portion 73) with the film 5 with the other hand, and rotating the cap 7 in the direction of arrow B, the film Since the rupture portion 6 is located at the portion where the stress is most generated in 5 (the portion corresponding to the boundary portion 11), the rupture portion 6 can be easily and reliably broken, that is, the plug-opening property is improved. . In addition, it is preferable that the breaking strength of the fracture | rupture part 6 in the state which the film 5 thermally contracted is 5-15N, and it is more preferable that it is 8-11N.

  As shown in FIG. 3, the fracture | rupture part 6 is comprised by the perforation. That is, the breaking portion 6 includes linear first cut lines (first slits) 61a and 61b, second cut lines (second slits) 62, third cut lines (third slits) 63, and fourth cut lines. (Fourth slit) 64 is provided. The first cut lines 61a and 61b, the second cut line 62, the third cut line 63, and the fourth cut line 64 have the same width (thickness) in the configuration shown in FIG. However, it may be different.

  As shown in FIG. 3, the first cut lines 61 a and 61 b are formed intermittently along the circumferential direction of the cap 7 and are alternately arranged (adjacent to each other). For this reason, when the cap 7 is opened, the first cut line 61a and the first cut line 61b are broken so that the first cut line 61a and the first cut line 61b are connected. A planned fracture portion (first fracture planned portion) 65 having a length g is formed.

  Further, the first cut lines 61a and 61b are located on the boundary portion 11 between the cap 7 and the lock adapter 23 of the outer cylinder 2 in a side view, that is, substantially coincide with (overlapping) the boundary portion 11. )

  The length a of the first score line 61a and the length b of the first score line 61b are different from each other. In other words, the length a of the first score line 61a is longer than the length b of the first score line 61b.

  Thus, in the fracture | rupture part 6, the 1st cut line 61a and the 1st cut line 61b from which length differs differingly are arrange | positioned. The film 5 is a part on the cap 7 side (hereinafter, this part is referred to as “cap side split part 52”) and a part on the outer cylinder 2 side (hereinafter, this part is referred to as “outer cylinder side split part 53”). Therefore, the cap 7 can be removed from the outer cylinder 2 (see FIGS. 9 and 10).

  As shown in FIG. 3, each of the first cut lines 61b intersects (connects) with the second cut line 62. Each second cut line 62 is disposed closer to the cap 7 than the boundary portion 11. The second cut line 62 has one end (one end) located at one end (one end) of the first cut line 61b at the front (right side in FIG. 3) in the rotation direction (arrow B direction) of the cap 7. Crosses 611.

  Each of the second cut lines 62 is inclined with respect to the first cut line 61b (first cut line 61a). Then, the second cut line 62 is inclined such that the inclination angle θ with respect to the first cut line 61b is an acute angle with respect to the rotation direction (arrow B direction) of the cap 7, that is, in a direction away from the first cut line 61b. It is formed (arranged) so as to extend toward. In addition, inclination | tilt angle (theta) is 10-70 degrees, Preferably it is 30-60 degrees.

  Since the second cut line 62 is formed as described above, when the cap 7 is opened, each break planned portion (second break line) between a third cut line 63 and a fourth cut line 64, which will be described later, is formed. The planned portion 66 can be reliably broken.

  The length c of the second cut line 62 is longer than either the length d of the third cut line 63 or the length e of the fourth cut line 64 (see FIG. 3). Thereby, when the fracture | rupture part 6 fractures | ruptures, it becomes easy to form the small piece 521 (refer FIG. 9) in the cap side division | segmentation part 52 (film 5) (it is easy to produce). Further, the small piece 521 is formed in a size that can be visually recognized. The small piece 521 includes a pair of first cut lines 61a and 61b, a second cut line 62 connected to the first cut line 61b, a third cut line 63 connected to the second cut line 62, and It is formed when the fourth cut line 64 in the vicinity of the third cut line 63 is continuous (connected), which will be described later.

  In the present specification, a pair of first cut lines 61a and 61b forming one small piece 521, a second cut line 62 connected to the first cut line 61b, and a second cut line 62 are connected. The third cut line 63 and the fourth cut line 64 in the vicinity of the third cut line 63 may be referred to as a “cut line group 60 (see FIG. 3)”. It can be said that the fracture portion 6 has a plurality of the cut line groups 60.

  As shown in FIG. 3, each of the second cut lines 62 intersects (connects) with the third cut line 63. Each third cut line 63 is disposed closer to the cap 7 than the boundary portion 11, similarly to the second cut line 62. The third cut line 63 has one end (one end) 631 intersecting the other end (other end) 622 of the second cut line 62. Accordingly, the third score line 63 is connected to the first score line 61 a via the second score line 62.

  Each third cut line 63 is formed in parallel with the first cut lines 61a and 61b.

  Since the third cut line 63 is formed as described above, when the cap 7 is opened, each planned break portion 66 can be reliably broken.

  The sum of the length d of the third cut line 63, the length b of the first cut line 61b, and the length c of the second cut line 62 is preferably 2 to 11 mm, more preferably 3 to 9 mm. preferable.

  As shown in FIG. 3, similarly to the third cut line 63, the fourth cut line 64 is spaced apart from the boundary 11 near the cap 7 in the vicinity of the other end 632 side of each third cut line 63. Is formed. The fourth cut line 64 is formed in parallel with the third cut line 63.

  By forming the fourth cut line 64 as described above, when the cap 7 is opened, each planned break portion 66 can be more reliably broken. Thereby, the small piece 521 is reliably formed in the cap side division | segmentation part 52 (film 5).

  The length e of the fourth cut line 64 is the same as the length d of the third cut line 63.

  Further, the minimum separation distance f between the third cut line 63 and the fourth cut line 64 is shorter than either the length d of the third cut line 63 or the length e of the fourth cut line 64.

  The sum of the length d of the third cut line 63, the length e of the fourth cut line 64, and the minimum separation distance f is not particularly limited, but is preferably 60 mm or less, for example. For example, when this sum is 2.5 mm, the length d can be 1 mm, the length e can be 1 mm, and the minimum separation distance f can be 0.5 mm.

  By setting in such a numerical range, the small piece 521 is easily formed in the cap-side split portion 52 when the break portion 6 is broken. Further, the small piece 521 is surely formed in a size that can be visually recognized.

  In addition, about each magnitude | size of length ag in the fracture | rupture part 6 of the structure shown in FIG. 3, it can set to the numerical range shown below.

  For example, the length a is preferably 1.5 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length b is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length c is preferably 1.0 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length d is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  The length e is, for example, preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length f is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

  For example, the length g is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

  In addition, since the third cut line 63 and the fourth cut line 64 are formed, the film 5 contracts in accordance with the hexagonal portion 72 and the lock adapter 23 of the cap 7 having a hexagonal cross sectional shape. In this case, the film 5 can be uniformly shrunk over the entirety thereof, and thus the adhesion between the cap 7 (hexagonal portion 72) and the lock adapter 23 is improved.

  Next, the state at the time of opening the cap 7 in the film 5 having the broken portion 6 having such a configuration will be described.

  As described above, when holding the lock adapter 23 of the outer cylinder 2 with the film 5 with one hand and holding the cap 7 with the film 5 with the other hand and opening the cap 7, the first cut line 61a and Each fracture | rupture planned part 65 between the 1st cut lines 61b is each fractured | ruptured. Thereby, the film 5 is divided | segmented into the cap side division part 52 and the outer cylinder side division part 53 (refer FIG. 9, FIG. 10).

  In addition, as each planned break portion 65 is broken, each of the planned break portions 66 between the third cut line 63 and the fourth cut line 64 is broken in the cap-side split portion 52. Thereby, in each cut line group 60, the first cut line 61a to the fourth cut line 64 are connected (become one continuous cut), and thus a long small piece 521 is formed (see FIG. 9). ). Thereby, the cap side division | segmentation part 52 becomes a thing (a petal-like thing) in which the several small piece 521 was formed, ie, the whirling occurred. Further, since the cap-side divided portion 52 is in close contact with the cap 7 by heat shrinkage as described above, it is prevented from being detached from the cap 7.

  On the other hand, the outer cylinder side divided portion 53 does not flutter, but is in a cleanly broken state (see FIG. 10). Moreover, since this cap side division | segmentation part 52 is closely_contact | adhered to the lock adapter 23 by heat shrink similarly to the cap side division | segmentation part 52, it is prevented from detaching | releasing from the lock adapter 23. FIG.

  Then, without using or using up the liquid preparation 200 in the outer cylinder 2, the cap 7 in the state shown in FIG. 9 is mounted again (recapped) on the outer cylinder 2 (lock adapter 23) in the state shown in FIG. ), Since the small pieces 521 of the number of the cap-side split portions 52 protrude at the boundary portion 11 between the cap 7 and the lock adapter 23 of the outer tube 2, the recapped syringe 1 (outer tube 2) is opened. It can be easily visually confirmed that the product has been used (used). Therefore, the syringe 1 has an excellent tamper-proof property (a fact that it has been once used can be confirmed later), and can reliably prevent the opened one from being used by mistake. .

<Second Embodiment>
FIG. 4 is a side view (enlarged view of a broken portion of a film) showing a second embodiment when the medical device of the present invention is applied to a prefilled syringe.

  Hereinafter, the second embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the formation state of the fourth cut line is different.

  In the fracture portion 6 </ b> A shown in FIG. 4, each fourth cut line 64 is inclined with respect to the third cut line 63. The fourth score line 64 is inclined in the same direction as the second score line 62, that is, is parallel to the second score line 62.

Further, as the formation position of the fourth cut line 64, in the present embodiment, one end 641 of the fourth cut line 64 is in contact with the third cut line 63 with respect to the vertical direction (the direction of the axis 223 of the mouth portion 22) in FIG. In the same position.
Further, the length e of the fourth score line 64 is longer than the length d of the third score line.

  By forming such a fourth cut line 64, the size of the small piece 521 formed by each cut line group 60 can be made larger than the size of the small piece 521 of the first embodiment. . Thereby, the small piece 521 becomes more conspicuous, and when recapped, it can be more easily confirmed visually that the recapped syringe 1 has been opened. Therefore, the syringe 1 has an excellent tamper proof property.

  In addition, about each magnitude | size of length ag in the fracture | rupture part 6A of the structure shown in FIG. 4, it can set to the numerical range shown below.

  For example, the length a is preferably 1.5 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length b is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length c is preferably 1.0 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length d is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length e is preferably 1.0 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length f is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

  For example, the length g is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

<Third Embodiment>
FIG. 5 is a side view (enlarged view of a broken part of a film) showing a third embodiment when the medical device of the present invention is applied to a prefilled syringe.

  Hereinafter, the third embodiment of the medical device of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the formation position of the fourth cut line is different.

  In the fractured portion 6B shown in FIG. 5, as the formation position of each fourth cut line 64, the other end 642 of the fourth cut line 64 is in the vertical direction in FIG. On the other hand, it is at the same position as the third cut line 63. Thereby, there exists an advantage called excellent in tamper-proof property.

  In addition, about each magnitude | size of length ag in the fracture | rupture part 6B of the structure shown in FIG. 5, it can set to the numerical range shown below.

  For example, the length a is preferably 1.5 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length b is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length c is preferably 1.0 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length d is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length e is preferably 1.0 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length f is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

  For example, the length g is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

<Fourth embodiment>
FIG. 6 is a side view (enlarged view of a broken portion of a film) showing a fourth embodiment when the medical device of the present invention is applied to a prefilled syringe.

Hereinafter, the fourth embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the fracture portion is different.

  In the fracture portion 6C shown in FIG. 6, each second cut line 62 is formed so as to cross the first cut line 61b across the first cut line 61b. The second cut lines 62 extend by the same length via the first cut lines 61b.

  In addition, third cut lines 63 extend from both ends (one end 621 and the other end 622) of each second cut line 62. That is, the third cut lines 63 are disposed on both sides via the first cut lines 61a and 61b.

  Furthermore, the 4th cut line 64 is also arrange | positioned on both sides via the 1st cut line 61a, 61b similarly to the 3rd cut line 63. FIG.

  In such a rupture portion 6C, when the opening operation is performed, a plurality of small pieces 521 are formed in the cap-side divided portion 52, and a small piece (not shown) is also formed in the outer cylinder-side divided portion 53. Multiple) are formed. Thereby, when it is recapped, it can be further easily confirmed visually that the recapped syringe 1 has been opened. Therefore, the syringe 1 has an excellent tamper proof property.

  In addition, in the fracture | rupture part 6C, the 3rd cut line 63 and the 4th cut line 64 by the side of the outer cylinder 2 are omissible.

  In addition, about each magnitude | size of length ag in the fracture | rupture part 6C of the structure shown in FIG. 6, it can set to the numerical range shown below.

  For example, the length a is preferably 1.5 to 5.0 mm, and more preferably 2.0 to 4.0 mm.

  For example, the length b is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  The length c is, for example, preferably 2.0 to 8.0 mm, and more preferably 3.0 to 6.0 mm.

  For example, the length d is preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  The length e is, for example, preferably 0.5 to 1.5 mm, and more preferably 0.8 to 1.2 mm.

  For example, the length f is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

  For example, the length g is preferably 0.2 to 1.0 mm, and more preferably 0.3 to 0.7 mm.

<Fifth Embodiment>
FIG. 7: is a side view (enlarged view of the fracture | rupture part of a film) which shows 5th Embodiment at the time of applying the medical device of this invention to a prefilled syringe.

  Hereinafter, the fifth embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  The present embodiment is the same as the first embodiment except that the crossing state (connection state) of the cut lines at the fracture portion is different.

  In the fracture | rupture part 6D shown in FIG. 7, the 1st cut line 61b and the 2nd cut line 62 cross | intersect in the middle of each other. Further, the second cut line 62 and the third cut line 63 also cross each other on the way.

  Even in the rupture portion 6D having such a configuration, a rupture state substantially similar to that of the rupture portion 6 of the first embodiment is obtained, and thus the tamper-proof property as described above is exhibited.

<Sixth Embodiment>
FIG. 8: is a side view (enlarged view of the fracture | rupture part of a film) which shows 6th Embodiment at the time of applying the medical device of this invention to a prefilled syringe.

  Hereinafter, the sixth embodiment of the medical device of the present invention will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  The present embodiment is the same as the first embodiment except that the shape of the fracture portion on the outer cylinder side is different.

  In the fracture | rupture part 6E shown in FIG. 8, the 2nd cut line 62a, the 3rd cut line 63a, and the 4th cut line 64a are arrange | positioned in the outer cylinder 2 side (base end side) rather than the boundary part 11. FIG.

  The second score line 62a intersects the first score line 61b at a position (the other end 612) different from the second score line 62 on the cap 7 side (tip side). The second score line 62 a is inclined in the same direction as the second score line 62. The second cut line 62a intersects the third cut line 63a in the middle of the third cut line 63a.

  The length of the third cut line 63 a is longer than that of the third cut line 63. Further, the third cut line 63 a is arranged in parallel to the third cut line 63 a.

  A fourth cut line 64a is disposed near the other end 632 side of the third cut line 63a. The fourth cut line 64a is bent halfway, that is, has a portion inclined in the same direction as the second cut line 62a and a portion parallel to the third cut line 63a.

  In such a breaking portion 6E, when the opening operation is performed, a plurality of small pieces 521 are formed in the cap-side divided portion 52, and a small piece (see FIG. (Not shown) are formed. Thereby, when it is recapped, it can be further easily confirmed visually that the recapped syringe 1 has been opened. Therefore, the syringe 1 has an excellent tamper proof property.

  As described above, the medical device of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the medical device has any configuration that can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  The medical device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  The medical device of the present invention can be suitably applied to a prefilled syringe, and is used for, for example, needles such as injection needles and indwelling needles, luer connectors, and the like. Moreover, it can apply suitably also between the cap and housing | casing in the cylindrical package which maintains the sterility of a product.

  Further, the prefilled syringe may be one in which the lock adapter is omitted. In this case, the cap can be fixed directly to the mouth portion by screwing.

  Moreover, in a fracture | rupture part, although the 2nd cut line is connected to the short 1st cut line among two types of 1st cut lines from which length differs, it is not limited to this, For example, both 1st cut lines It may be connected to one cut line or may be connected to the longer first cut line.

  Further, the first score line, the second score line, the third score line, and the fourth score line may each be formed in advance before the film is thermally contracted, or the film is thermally contracted. It may be formed later.

  Moreover, a film is not limited to what has heat shrinkability, The thing which does not have heat shrinkability may be sufficient. When the film does not have heat shrinkability, the film may be fixed to the cap or the lock adapter with an adhesive. In addition, it is preferable that an adhesive agent is provided to the area | region in which the 1st cut line of a film, the 2nd cut line, the 3rd cut line, and the 4th cut line are not formed.

1 Syringe (Prefilled Syringe) (medical device)
11 boundary 2 outer cylinder (syringe outer cylinder) (medical device body)
DESCRIPTION OF SYMBOLS 20 Inner peripheral surface 21 Outer cylinder main body 211 Bottom part 22 Mouth part 221 Flow path 222 Male taper part 222a Outer diameter fixed part 223 Shaft 224 Tip opening 23 Lock adapter 232 Female screw 235 Reduced diameter part 24 Space 25 Flange 27 Detaching prevention member 271 Surface 3 Gasket 31, 32 Projection 4 Pusher (plunger)
40 body part 41 plate member 42 finger contact part 43 plate member 431 surface 5 film 51 tip edge part 52 cap side split part 521 small piece 53 outer cylinder side split part 6, 6A, 6B, 6C, 6D, 6E breaking part 60 cut line Group 61a, 61b First cut line (first slit)
611 One end (one end)
612 Other end 62, 62a Second cut line (second slit)
621 One end (one end)
622 The other end (the other end)
63, 63a Third cut line (third slit)
631 One end (one end)
632 Other end 64, 64a Fourth cut line (fourth slit)
641 One end 642 The other end 65 Expected fracture part (first fracture intended part)
66 Planned fracture part (second fracture planned part)
7 Cap 71 Cap body 711 Lumen portion 712 Bottom portion 713 Tip surface 72 Hexagonal portion 73 Grip portion 731 Groove 74 Screw portion 741 Male screw 75 Shaft 76 Packing 200 Liquid preparation a, b, c, d, e, f, g Length F Minimum separation distance L1 Distance θ Inclination angle

Claims (8)

A medical device body having a tubular mouth;
A cap that is attached to the mouth and is opened by rotating around the axis of the mouth;
The cap and the medical device main body are collectively covered with the cap attached to the mouth portion, and a film having a fracture portion that is broken when the cap is opened,
The breaking portion includes a plurality of first cut lines formed intermittently along the circumferential direction of the cap;
A second score line extending in a direction away from all or part of the first score line with an inclination angle of 10 to 70 ° with respect to the first score line;
A third score line extending from the second score line;
A medical device comprising a fourth cut line formed apart from the third cut line in the vicinity of the third cut line.   The medical device according to claim 1, wherein the third cut line is formed in parallel to the first cut line or has a parallel portion.   The medical instrument according to claim 1 or 2, wherein one end of the fourth cut line is located at the same position as the third cut line with respect to the axial direction of the mouth portion.   The medical treatment according to any one of claims 1 to 3, wherein a minimum separation distance between the third incision line and the fourth incision line is shorter than any length of the third incision line and the fourth incision line. Tools.   The medical device according to any one of claims 1 to 4, wherein the second cut line is connected to one of the two adjacent first cut lines.   The medical device according to any one of claims 1 to 5, wherein the second cut line is connected to an end portion of the first cut line that is positioned forward in the rotation direction of the cap.   The medical device according to any one of claims 1 to 6, wherein a length of the second cut line is longer than a length of either the third cut line or the fourth cut line.   The medical device according to any one of claims 1 to 7, wherein adjacent first cut lines have different lengths.

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