JP2019034072A - Closed type medicine transfer system - Google Patents

Abstract

To provide a closed type medicine transfer system that is able to securely grasp a vial bottle without dropping it.SOLUTION: A closed type medicine transfer system 1 comprises: a vial adapter 3 having a hollow needle member 32 with which a rubber stopper 21 sealing a mouth part of a vial bottle 2 is pierced and a plurality of grasping members 34 for grasping the vial bottle 2; and an internal connector 4 connecting the vial adapter 3 and a medical appliance. Along an outer peripheral surface between the vial adapter 3 and the internal connector 4, a frame member 7 is provided, which is slidable between a first position for allowing pressed deformation of the grasping members 34 and a second position for regulating pressed deformation of the grasping members 34.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a closed drug delivery system.

  Traditionally, closed drugs to avoid exposure to health care workers when handling anti-cancer drugs that may adversely affect normal cells or tissues, or drugs containing radioisotopes for testing, etc. A transfer system is used.

  The closed drug transfer system includes, for example, a vial adapter that holds a vial filled with a drug such as the anticancer drug, and a hollow cylindrical connecting member that connects the vial adapter and a medical instrument. Those are known (for example, see Patent Document 1). In the closed drug delivery system described in Patent Document 1, the vial adapter includes a hollow needle member that is pierced by a rubber stopper that seals a mouth portion of the vial, and a predetermined interval on an outer peripheral side of the hollow needle member. And a plurality of gripping members that are elastically pressed against the neck of the vial when the hollow needle member is pierced into the vial and grips the vial.

  According to the closed drug transfer system, the hollow needle member of the vial adapter is punctured into the vial, and the syringe connected to the connecting member in a state where the vial is held by the holding member With this medical device, it is possible to inject a chemical solution into the vial while being isolated from the outside air, or to extract the chemical from the vial.

Japanese Patent Application Laid-Open No. 2015-65985

  However, in the conventional closed drug delivery system, since the gripping member of the vial adapter is elastically pressed against the neck of the vial and only grips the vial, a large force is applied to the vial. If added, the vial may drop from the gripping member, and the medicine inside may scatter and the medical staff may be exposed to the medicine.

  An object of the present invention is to provide a closed drug delivery system that can eliminate such inconvenience and can reliably hold the vial without dropping it.

  In order to achieve this object, the closed drug delivery system of the present invention comprises a hollow needle member that is pierced by a rubber stopper that seals the mouth of a vial, and an elastic body on the outer peripheral side of the hollow needle member. A vial adapter comprising: a plurality of gripping members that are elastically pressed and deformed to the neck of the vial when the hollow needle member is pierced into the mouth of the vial; and A hollow cylindrical connecting member that connects the vial adapter and the medical device, and injects the drug solution into the vial through the vial adapter and the connection member in a state where the vial adapter and the connection member are blocked from the outside air; In the closed drug transfer system to be extracted, a first position allowing the pressing deformation of the gripping member and the pressing deformation of the gripping member are regulated along the outer peripheral surface of the vial adapter and the connecting member. Characterized in that it comprises a slidable frame member and a second position that.

  In the closed drug delivery system of the present invention, first, in a state where the frame member is in the first position and pressing deformation of the gripping member is allowed, the hollow needle member is placed in the mouth of the vial. Puncture. In this case, the gripping member moves in the direction of the mouth of the vial along with the puncture of the hollow needle member, but the gripping member is in a state in which the pressing deformation is allowed. , Once extending in the outer circumferential direction, after having passed over the mouth, it is elastically pressed against the neck of the vial to grip the vial.

  Next, the hollow needle member of the vial adapter is moved to the second position by sliding the frame member along the outer peripheral surface of the vial adapter and the connection member, and moving the frame member to the second position. The pressure deformation of the gripping member is regulated while the vial is gripped by the gripping member. As a result, the holding member is prevented from spreading to the outer peripheral side by the frame member, and the vial can be prevented from dropping from the holding member.

  Further, in the closed drug delivery system of the present invention, the frame member prevents the connection of the medical device to the connection member at the first position, and the medical device is connected to the connection member at the second position. It is preferable to provide a connection control member that enables connection.

  According to the closed drug delivery system of the present invention including the connection control member, when the frame member is in the first position, the connection control member prevents the connection of the medical instrument to the connection member, When the frame member is moved to the second position, the connection prevention of the medical instrument by the connection control member is released, and the medical instrument can be connected to the connection member. Therefore, the medical device is connected to the connection member in a state where the frame member regulates the pressing deformation of the gripping member at the second position and prevents the vial from dropping off from the gripping member. can do.

  In the closed drug delivery system of the present invention, the connection is made by connecting a medical instrument such as a syringe to the connection member in a state where the hollow needle member of the vial adapter is punctured into the mouth of the vial. A medical solution such as physiological saline can be injected into the vial through the member and the hollow needle member of the vial adapter. By the way, at this time, a gas such as air coexists in the vial bottle, and when the space in the vial bottle is narrowed by injecting the drug solution, the gas loses its place and the mouth portion There is a risk that medical personnel will be exposed to the droplets and aerosols.

  Therefore, the closed drug transfer system according to the present invention includes a foldable flexible container that evacuates the gas in the vial, and a housing that accommodates the folded flexible container, the hollow The needle member includes a first path that communicates the inside of the vial and the inside of the connection member, and a second path that communicates the inside of the vial and the flexible container, and the frame member includes Preferably, the flexible container in a deployed state when in the second position is received in cooperation with the housing.

  According to the closed drug transfer system of the present invention having such a configuration, when the drug solution is injected into the vial from the first path of the hollow needle member, the gas in the vial is By the second path of the hollow needle member, it can be retracted to the flexible container, and it can be prevented from exploding from the mouth.

  Further, at this time, the flexible container is expanded by the gas evacuated from the inside of the vial bottle and the volume thereof is increased. However, since the frame member is in the second position, the flexible container is placed in the housing and the frame member. It is in a housed state. As a result, the flexible container in a deployed state is protected by the housing and the frame member and is not subjected to external pressure, and bursts by receiving the pressure and the internal gas is scattered. Medical workers and the like can be prevented from being exposed to the gas.

The perspective view which shows the state which has a frame member in a 1st position in one structural example of the closed type drug delivery system of this invention. II-II sectional view taken on the line of FIG. III-III sectional view taken on the line of FIG. IV-IV sectional view taken on the line of FIG. The perspective view which shows the state which has a frame member in a 2nd position in the closed type drug delivery system of this invention shown in FIG.

  Next, embodiments of the present invention will be described in more detail with reference to the accompanying drawings.

  As shown in FIG. 1, the closed drug transfer system 1 of the present embodiment is a connection member that connects a vial adapter 3 connected to a vial 2 and a medical device such as a male connector (not shown). The female connector 4, the housing 6 that accommodates the foldable flexible container 5 that evacuates the gas in the vial 2, and the outer peripheral surfaces of the vial adapter 3, the female connector 4, and the housing 6. And a slidable frame member 7.

  As shown in FIGS. 2 and 3, the vial adapter 3 includes a hollow cylindrical main connection portion 31 and a septum (rubber plug) that protrudes from the lower end portion of the main connection portion 31 and seals the mouth portion of the vial 2. 21, a pair of arm members 33 extending in the outer peripheral direction from the lower end portion of the main connection portion 31, and a gripping member 34 depending from the end portion of the arm member 33. The main connection part 31, the hollow needle member 32, the arm member 33, and the gripping member 34 of the vial adapter 3 are integrally formed of a synthetic resin having elasticity.

  The main connection portion 31 includes a hollow portion 311 into which the female connector 4 is inserted, and a hollow cylindrical housing connection portion 312 that extends from the outer peripheral surface in the horizontal direction and is connected to the housing 6. The hollow portion 311 includes a tapered surface 313 on the inner peripheral surface, and the tapered surface 313 gradually increases in diameter from the distal end side toward the opening end of the hollow portion 311. The hollow portion 314 of the housing connecting portion 312 has a tapered surface 315 on the inner peripheral surface, and the tapered surface 315 gradually increases in diameter from the main connecting portion 31 side toward the opening end connected to the housing 6. . The main connection portion 31 includes a pair of projecting portions 316 that project from the open end of the hollow portion 311 to the outer peripheral side.

  The hollow needle member 32 is provided with a first path 322 and a second path 323 that open to the needle tip 321 while having a sharp needle tip 321 at the tip. The first path 322 communicates with the hollow part 311 of the main connection part 31, and the second path 323 communicates with the hollow part 314 of the housing connection part 312. The first path 322 includes a slit 324 that opens on the side surface of the hollow needle member 32, and the slit 324 extends from the needle tip portion 321 toward the lower end portion of the main connection portion 31.

  The gripping member 34 is formed so as to be inclined from the end of the arm member 33 toward the vial 2, and the distance between the tips of the pair of gripping members 34 is larger than the outer diameter of the neck 22 of the vial 2. It is designed to be slightly narrower. As a result, the gripping member 34 is urged toward the neck 22 of the vial 2 by its own elasticity, and the tip is pressed against the neck 22 of the vial 2 to grip the vial 2. Further, the gripping member 34 includes a window portion 341 between the distal end portion and the proximal end portion, and when the distal end portion is pressed against the neck portion 22 of the vial 2, the gripping member 34 has an outer peripheral side from the mouth portion of the vial 2. The flange portion 23 extending in the window portion 341 is accommodated in the window portion 341. The gripping member 34 has an arcuate recess 342 at the tip, and the recess 342 is pressed against the neck 22 of the vial 2.

  The female connector 4 includes a hollow cylindrical outer shell 41, an adapter connection member 42 disposed in the outer shell 41 and connected to the vial adapter 3, and a hollow cylindrical outer shell connected to the adapter connection member 42. And a valve seat member 43. The outer shell body 41 includes a large-diameter portion 411 that is externally fitted to the adapter connection member 42 and a small-diameter portion 412 that is externally fitted to the valve seat member 43. A locking pin 413 is provided. The locking pin 413 is locked when the medical device such as a male connector is connected to the female connector 4.

  The adapter connecting member 42 includes a hollow cylindrical inner tube 421 and an outer tube 422 disposed on the outer peripheral side of the inner tube 421 and connected to the inner tube 421 at the base end. A female threaded portion 423 is provided on the peripheral surface of the projecting portion 316 of the main connecting portion 31. The outer peripheral surface of the inner tube 421 is a tapered surface that is fitted to the tapered surface 313 of the hollow portion 311.

  The adapter connection member 42 includes a cylindrical protrusion 424 communicating with the inner tube 421 at the base end portion, and includes a plurality of vertical ribs 425 on the outer peripheral surface of the outer tube 422. The vertical rib 425 supports the outer shell body 41 at the base end portion.

  The valve seat member 43 has a base end portion fitted into the small diameter portion 412 of the outer shell body 41, and the first valve body 431 is disposed at the base end portion, while the tip end portion is a cylinder of the adapter connection member 42. The second valve element 432 is disposed at the tip end of the protrusion 424. Both the first valve body 431 and the second valve body 432 are made of a soft resin. The first valve body 431 includes a slit 433 at the center, and a medical instrument such as a male connector is inserted into the slit 433. The valve is opened when the valve is removed, and the valve is closed when the valve is removed.

  The valve seat member 43 includes an extending portion 434 extending in the axial direction along the second valve body 432 from the inner peripheral surface, and a through hole 435 provided in the center of the extending portion 434, A guide receiving portion 436 is provided around the through hole 435 and protrudes toward the base end portion. The guide receiving portion 436 receives and guides the distal end portion of a medical instrument such as a male connector inserted into the first valve body 431 to the shaft side.

  The housing 6 is a bottomed box-shaped hollow body, and includes a housing main body 61 that houses the flexible container 5 in a folded state, and a locking member 62 that locks the housing main body 61 to the vial adapter 3. ing. The housing body 61 and the locking member 62 of the housing 6 are integrally formed of a synthetic resin having elasticity.

  The housing body 61 includes an insertion hole 611 into which the housing connection portion 312 of the vial adapter 3 is inserted in the side wall, and is fixed to the vial adapter 3 by a hollow cylindrical connection member 612 inserted into the housing connection portion 312. . The connection member 612 includes an insertion portion 613 inserted into the housing connection portion 312 and a flange portion 614 provided at an end portion of the insertion portion 613 on the housing main body 61 side and locked to the inner surface of the side wall of the housing main body 61. The outer peripheral surface of the insertion portion 613 is a tapered surface that is fitted to the tapered surface 315 of the hollow portion 314. The flexible container 5 is connected to the flange part 614, and the inside of the folded flexible container 5 communicates with the hollow part 314 of the housing connection part 312 via the insertion part 613.

  Further, the housing main body 61 is provided with a protrusion 615 that locks the frame member 7 and a protrusion 616 (see FIG. 1) at the end edge on the front end side.

  As shown in FIG. 4, the locking member 62 includes a shaft member 621 that protrudes toward the vial adapter 3 from the outer surface of the side wall of the housing body 61, and a U-shaped member 622 provided at the tip of the shaft member 621. . The distance between the tip portions of the U-shaped member 622 is slightly narrower than the outer diameter of the main connection portion 31. As a result, when the housing 6 is locked to the vial adapter 3 and the housing body 61 is pressed from the direction orthogonal to the axis of the main connection portion 31, the U-shaped member 622 once expands in the outer peripheral direction due to its own elasticity. After overcoming the widest portion corresponding to the outer diameter of the main connection portion 31, it is elastically restored to its original shape and is locked to the outer peripheral surface of the main connection portion 31.

  As shown in FIGS. 1 to 3, the frame member 7 includes a first box-shaped portion 71 along the outer peripheral surface of three surfaces excluding the housing 6 side on the side surface of the vial adapter 3, and a first box-shaped portion 71. A second box-like portion 72 along the outer peripheral surface of the three surfaces excluding the vial adapter 3 side on the side surface of the housing main body 61; a bottom surface portion 73 connected to the proximal end side of the first box-like portion 71; A hollow cylindrical portion 74 which is erected on the bottom surface portion 73 and extends along the outer peripheral surface of the female connector 4. The first box-shaped portion 71, the second box-shaped portion 72, the bottom surface portion 73, and the hollow cylindrical portion 74 of the frame member 7 are integrally formed of a synthetic resin having elasticity. The frame member 7 has a first position (the state shown in FIG. 1) that allows the pressing deformation so that the holding member 34 pressed by the vial 2 can be deformed so as to expand in the outer circumferential direction, and the holding member. It is possible to slide between a second position (state shown in FIG. 5) that restricts the pressing deformation of 34 and restrains the gripping member 34 in a state of being pressed against the neck portion 22 of the vial 2.

  The first box-shaped portion 71 includes a plurality of lateral ribs 711 on the side surface corresponding to the gripping member 34 of the vial adapter 3. The lateral rib 711 is used as a finger hook when sliding the frame member 7.

  The second box-like portion 72 includes engagement holes 721a and 722a with which the projections 615 and 616 formed in the housing body 61 are engaged at the end edge on the distal end side, and the end on the proximal end side Engagement holes 721b and 722b are provided at the edge.

  The hollow cylindrical portion 74 includes a notch portion 741 formed along the axial direction on the housing 6 side, and the notch portion 741 is engaged with the locking member 62 when the frame member 7 is slid as described above. The shaft member 621 can be inserted. In addition, the hollow cylindrical portion 74 has a pair of each of the locking pins 413 as a connection control member that shields the locking pins 413 at the base end side edge and prevents connection of a medical instrument such as a male connector. Two pairs of shielding pieces 742 are provided. The shielding piece 742 shields the locking pin 413 when the frame member 7 is in the first position, and is pressed against the outer peripheral surface of the outer shell body 41 when the frame member 7 is in the second position. The locking pin 413 is exposed.

  Next, the operation of the closed drug delivery system 1 of the present embodiment will be described.

  In the closed drug delivery system 1, first, the frame member 7 is set to the first position shown in FIG. 1, and the pressing deformation is allowed so that the gripping member 34 can expand in the outer peripheral direction. At this time, in the frame member 7, the engagement holes 721 a and 722 a of the second box-shaped portion 72 are engaged with the protrusions 615 and 616 formed in the housing body 61, and the hollow cylindrical portion 74 A shielding piece 742 shields the locking pin 413.

  Next, the hollow needle member 32 of the vial adapter 3 is punctured into the septum 21 of the vial bottle 2 in the above-described state. In this manner, the gripping member 34 is brought into contact with the flange portion 23 of the vial 2 as the hollow needle member 32 is pushed in. However, the gripping member 34 is in a state where the above-described pressing deformation is allowed. Is expanded in the outer circumferential direction.

  Next, when the gripping member 34 gets over the flange portion 23, it is pressed against the neck portion 22 of the vial 2 by its own elasticity to grip the vial 2. At this time, the gripping member 34 is pressed against the neck 22 of the vial 2 by an arc-shaped recess 342 provided at the tip, while the flange portion 23 of the vial 2 is accommodated in the window 341, so that the recess 342 Is not prevented from being pressed against the neck portion 22.

  Next, in a state where the vial 2 is gripped by the gripping member 34, the frame member 7 is slid along the outer peripheral surfaces of the vial adapter 3, the female connector 4, and the housing 6. Move to position. In the second position, since the first box-shaped portion 71 is located on the outer peripheral side of the gripping member 34, the pressing deformation of the gripping member 34 to the outer peripheral side is restricted by the first box-shaped portion 71, The state is constrained to be in a state of being pressed against the neck portion 22 of the vial 2.

  At this time, in the frame member 7, the engagement holes 721 b and 722 b of the second box-shaped portion 72 are engaged with the projections 615 and 616 formed in the housing body 61, and the hollow cylindrical portion 74 The shielding piece 742 is pressed against the outer peripheral surface of the outer shell body 41 to expose the locking pin 413.

  Therefore, next, a medical instrument such as a male connector (not shown) is connected to the female connector 4, and a liquid such as physiological saline is supplied from the medical instrument to the vial 2 via the first path 322 of the hollow needle member 32. The drug, such as an anticancer drug, contained in the vial 2 is diluted with the physiological saline or dissolved in the physiological saline and is actually administered to the patient. The chemical solution is prepared. At this time, a gas such as air coexists in the vial 2 in addition to the drug, but the gas is hollow when the space in the vial 2 is narrowed by injection of the physiological saline or the like. The second container 323 of the needle member 32 can be retracted to the flexible container 5. Therefore, even if the space in the vial 2 is narrowed by the injection of the physiological saline or the like, the medicine can be prevented from explosively splashing from the mouth portion of the vial 2.

  Further, at this time, the flexible container 5 is expanded by the gas evacuated from the inside of the vial 2 and the volume is increased. However, since the frame member 7 is in the second position, the second of the housing 61 and the frame member 7 is increased. Is housed in a box-like portion 72. As a result, the expanded flexible container 5 is protected by the housing 6 and the second box-like portion 72 and is not subjected to external pressure, but is burst due to the pressure and the internal gas is ruptured. It is possible to prevent scattering.

  Next, when the preparation of the drug solution is completed, the drug solution is extracted from the vial 2 via the first path 322 of the hollow needle member 32 by the medical instrument. At this time, in the closed drug delivery system 1 of the present embodiment, since the first path 322 includes the slit 324, the remaining liquid of the drug solution can be reduced as much as possible by reversing the top and bottom. . If the said chemical | medical solution is extracted, the said medical device will be extracted from the female connector 4, and the closed type drug delivery system 1 will be discarded.

  According to the closed type drug transfer system 1 of the present embodiment, by doing so, the medicinal solution can be prepared while being securely grasped without dropping the vial 2, Exposure to the drug in the vial 2 can be prevented.

  DESCRIPTION OF SYMBOLS 1 ... Closed type drug delivery system, 2 ... Vial bottle, 3 ... Vial adapter, 4 ... Female connector (connection member), 5 ... Flexible container, 7 ... Frame member, 21 ... Septum (rubber stopper), 22 ... Neck part 32 ... Hollow needle member, 34 ... Gripping member, 322 ... First path, 323 ... Second path, 742 ... Shielding piece (connection control member).

Claims (3)

A hollow needle member that is pierced into a rubber stopper that seals the mouth portion of the vial, and an elastic body that is provided on the outer peripheral side of the hollow needle member and when the hollow needle member is pierced into the mouth portion of the vial A vial adapter comprising: a plurality of gripping members that are elastically pressed and deformed to the neck of the vial and grip the vial;
A hollow cylindrical connecting member for connecting the vial adapter and the medical instrument;
In a closed drug transfer system that injects a drug solution into a vial through the vial adapter and the connection member in a state of being blocked from outside air, or extracts a drug solution from the vial,
Along the outer peripheral surface of the vial adapter and the connecting member, the gripping member can slide between a first position allowing the pressing deformation and a second position regulating the pressing deformation of the gripping member. A closed type drug delivery system comprising a frame member.   2. The closed drug delivery system according to claim 1, wherein the frame member prevents connection of the medical device to the connection member at the first position and connection of the medical device to the connection member at the second position. A closed drug delivery system comprising a connection control member that enables the above.   The closed drug transfer system according to claim 1 or 2, comprising a foldable flexible container for retracting the gas in the vial and a housing for accommodating the flexible container in a folded state. The hollow needle member includes a first path communicating between the inside of the vial and the inside of the connection member, and a second path communicating between the inside of the vial and the flexible container, The closed drug delivery system, wherein the frame member accommodates the flexible container in a deployed state when the frame member is in the second position in cooperation with the housing.