JP6779254B2 - Placement in medical connector equipment - Google Patents

Description

The present invention relates to a protective connection device for connecting a first medical device to a second medical device in a hygienic and safe state.

A major problem with drug preparation, drug administration, or the handling of other similar drugs is the risk of healthcare professionals and pharmacists being exposed to drugs or solvents that may escape into the ambient air. This problem is especially acute when it comes to cytotoxins, antivirals, antibiotics, and radiopharmaceuticals. Other risks may arise when collecting samples for viral infections and the like.

Some drugs must be dissolved or diluted prior to administration, which involves transferring the solvent from one container to a sealed vial containing the powdered or liquid drug, eg, by needle. .. If there is a pressure difference between the inside of the vial and the surrounding atmosphere, the drug is unintentionally released into the atmosphere as a gas or by aerosolization while the needle is pulled out of the vial and while the needle is in the vial. There is a risk of

For these reasons, systems have been developed to handle and administer drugs and other medical substances with increased safety.

Patent Document 1 discloses a fluid transfer device for preventing air pollution when transferring a substance from one container to a second container. The device includes a first member that is attached to or connectable to a container and contains a puncture member such as a hollow needle. The first member has a sealing member through which the needle can pass. The device further comprises a second member, which can be removably connected to the first member and further holds a sealing member. When the first member and the second member are connected to each other, the two sealing members are positioned relative to each other so that they can be penetrated by a puncture member movable with respect to the sealing member.

The sealing member used in the secure transfer connection devices disclosed herein is a flexible, elastically compressible, liquid and gas impermeable membrane, which is a liquid and gas component. Also known as a barrier or septum that can be tightly sealed after penetration and retraction of the puncture member to prevent spillage.

The commonly used sealing member is made of a thermoplastic elastomer polymer material (TPE) and can be attached into the connecting device by thermal welding such as ultrasonic welding.

U.S. Pat. No. 4,564,054

The medical transfer connection device is designed to be used repeatedly and intermittently, for example, when removing individual doses of a drug from a vial or when connecting an injection device to a catheter, intravenous injection device, or the like. It is not uncommon for each transfer connection device to be used multiple times, such as up to 10 times, before it is finally discarded or replaced. The device can often be left for several hours with the sealing member exposed to the environment after use until the next use. Connecting devices are used in non-sterile environments and in environments where the risk of contamination by bacteria and other hazardous substances can be high, such as in wards. Since the connecting device may be used for a long time in such a state, it faces a risk of bacterial growth on the sealing member. Therefore, it is highly desirable that the device and especially the sealing member of the device be cleaned before each new use, especially if it has been a long time since the last use. If the sealant is not thoroughly cleaned before use, there is a risk that bacteria will enter the medical transfer system and eventually be sent to the patient, causing distress and increasing medical costs.

Therefore, there is a need for a medical transfer connection device for use in medical devices that handle fluids such as pharmaceuticals, which can be easily and efficiently cleaned.

According to the present invention, it is a medical transfer connection device for connecting a first medical device to a second medical device, which has axial and radial directions, and has a first end and an end opening. A central tube comprising a second end and an outer component having a axially extending hole between the first end and the second end, holding a barrier member and extending axially. The inner part having the barrier member is nested in the hole of the outer part, and the inner part having the barrier member has the barrier member in the hole of the outer part. A shaft between a shielding position that is completely positioned inside and a cleaning position where the barrier member is positioned with at least a portion of the barrier member axially extending past the end opening of the outer component. A directionally movable, medical transport connection device is provided.

At the shielding position, the inner component of the transfer connection device is completely positioned inside the outer component, and the barrier member is radially shielded by the outer component. At the cleaning position, the barrier member projects from the outer component of the transfer connection device and is easily accessible for cleaning. After cleaning, the inner component can be retracted into the outer component of the transfer connection device, which allows the transfer connection device to be usable and the barrier member can be safely and hygienically punctured by the puncture member. During use of the device for transferring material between two medical devices, the outer component serves to protect the barrier member and the puncture site from contamination and stabilizes the medical device holding the puncture member. Form a connection or support. The central tube of the inner component of the device can pass a puncture member of the first medical device through the transfer connection device to remove fluid from the second medical device or the second medical device. It serves to guide and shield the puncture member when it is inserted into the second medical device to deliver the fluid to.

Therefore, according to the present invention, the inner component and the outer component of the transfer connection device can be moved relative to each other, so that the barrier member of the inner component can be moved to a position where it can be easily washed. .. In a transfer connection device known in the art, cleaning of the barrier member is performed using a cotton chip that reaches the barrier member inside the transfer connection device. Since it is in a fixed position inside the transfer connection device, it is difficult to reach all exposed parts of the barrier member and clean them efficiently. In the transfer connection device according to the present invention, when the barrier member is placed in the cleaning position, the barrier member can be quickly and sufficiently cleaned by a simple wiping.

The relative expansion and contraction movements of the outer and inner parts of the transfer connection device according to the present invention can be achieved by any suitable method.

For example, the outer component of the device may be provided with at least one axially extending groove, and the inner component may be provided with corresponding means for sliding engagement with at least one groove of the outer component. it can.

Means for sliding engagement with the at least one groove can include spring struts, protrusions, ridges, or similar elements protruding from the inner component.

When the means for sliding engagement with the groove of the outer component includes a spring strut, the spring strut may extend to the second end side of the inner component and passes through the transfer connection device. It may be tilted slightly outward with respect to the central axis. It may be preferred that at least two spring struts be placed on the inner component of the transfer connection device. When two or more spring struts are used, they are preferably arranged symmetrically on the inner component. For example, it is preferable that the two spring columns are arranged on the inner component so as to face each other in the radial direction.

The means for sliding engagement with the at least one groove may include one or more protrusions. In addition to one or more spring struts, or in place of one or more spring struts, said one or more protrusions may be used.

The grooves and protrusions of the outer component may be configured to form a bayonet fit between the outer and inner components of the transfer connection device.

The transfer connection device may include means for releasably locking the inner component to the shielded position. In addition, the transfer connection device may include means for releasably locking the inner component to the cleaning position. The locking means may be a bayonet fitting or, as is known in the art, a retaining element such as a retaining notch, retaining projection, snap lock or the like arranged in the hole of the outer component.

The transfer connection device may include means for connecting the device to a first medical device such as a medical vial or catheter.

The transfer connection device may include connecting means for connecting the device to a second medical device including a puncture member.

Definitions "Sterilized" or "sterile" equipment means equipment that has undergone a sterilization method to remove viable microorganisms, which method has been approved by relevant agencies for current products. Current European regulations for designating medical devices as "sterile" are found in European standard EN558-1. Other rules may exist in other countries. Sterilization may be ethylene oxide sterilization, radiation sterilization, or (wet) heat sterilization, or any other recognized method. European standard requirements mean that the theoretical likelihood of presence of viable microorganisms in sterilized equipment is less than 1 × 10 ^-6 .

The barrier member of the transfer connection device of the present invention is made of materials called "flexible", "expandable", and "compressible". As used herein, these expressions refer to materials that are elastically flexible, expandable or compressible under the influence of external forces and substantially return to their original state when the external forces are removed. Is. A "flexible" material is a material that can be easily folded, twisted or curved by hand, or repeatedly bent and without the occurrence of breakage or visible defects as defined in ISO 472: 1999 "Plastic-Terminology". / Or means a material that can be curved.

As used herein, "elastomer" means a polymeric material that quickly returns to its original dimensions and shape after a weak stress and substantial deformation due to stress relief. This definition applies under room temperature test conditions and is found in IS0472: 1999.

The parts of the transfer connection device may be molded from a relatively rigid plastic, as is known in the art. The rigid plastic material of the object of the present invention retains its shape during normal use and the force required to operate the transfer connection device between the shielding position and the cleaning position, or the device being the first medical device and the first medical device. A material that is not bent or deformed by the force required to connect to the medical device of 2. However, it is preferred that the rigid plastic material useful in the transfer connection device according to the present invention is elastically flexible and deformable by a greater force such as a force generated during assembly of the transfer connection device.

The present invention will be described in more detail with reference to the accompanying drawings below.
It is a figure which shows the transfer connection device in the configuration in use. It is an end view of the transfer connection device of FIG. It is an exploded view of the transfer connection device of FIG. It is a perspective view of the outer part of the transfer connection device of FIG. It is a side view of the inner part of the transfer connection device of FIG. It is a cross-sectional view of the transfer connection device of FIG. 1 taken along the line VI-VI of FIG. It is a cross-sectional view of the transfer connection device of FIG. 1 taken along the line VII-VII of FIG. It is a cross-sectional view of the transfer connection device of FIG. 1 at the cleaning position taken along the line VI-VI of FIG. 2 is a cross-sectional view of the transfer connection device of FIG. 1 at the cleaning position taken along line VII-VII of FIG.

The medical transfer connection device 1 shown in FIGS. 1 to 9 has an elongated tubular shape as a whole, and the outer component 2 is arranged in a nested manner with the inner component 3 inserted into the center hole 4 of the outer component 2. And an inner part 3 is provided. The transfer connection device 1 has an axial direction A and a radial direction R perpendicular to the axial direction A. The inner component 3 has a first end 5, a second end 6, and a central passage tube (central canal) 7 extending in the axial direction A and concentrically arranged in the central hole 4 of the outer component 2. The outer component 2 has a first end 8 and a second end 9 with an end opening 10, and a center hole 4 extends between the first end 8 and the second end 9. .. The central canal 7 of the inner component 3 is positioned at the second end 9 of the outer component 2 while the puncture member is inserted into another medical device located at the first end 8 of the outer component 2. Arranged to guide and protect the puncture member on the device.

The inner component 3 holds the barrier member 12, which, as most commonly seen in FIGS. 6 and 7, is at the second end 6 of the inner component 3 and into the central canal 7 of the inner component 3. It is applied to seal the central canal 7. The barrier member is a flexible elastically compressible membrane or septum, as disclosed herein, for the transfer of unwanted material from one side of the barrier member 12 to the other side of the barrier member 12. It acts as a barrier to ensure a hygienic and secure connection between the two medical devices. The barrier members of the present invention can be made from medical grade elastomeric polymer materials, as is known in the art. Examples of such materials include silicone elastomers, natural elastomers, and thermoplastic elastomer polymer materials (TPEs). Examples of thermoplastic elastomers include styrene block copolymers (TPS), thermoplastic polyolefins (TPO), thermoplastic polyurethanes (TPU), copolyesters, and polyether blockamides.

In particular, with reference to FIGS. 2, 3 and 5, the inner component 3 comprises a cylinder 14 having two spring struts 15, which extend towards and transfer to the second end of the inner component 3. It is slightly inclined outward with respect to the central axis 16 passing through the connecting device 1. The spring struts 15 are arranged so as to face each other in the radial direction and are terminated at free ends having contact surfaces 17 arranged to cooperate with the corresponding contact surfaces of the outer component 2 of the transfer connection device 1. .. The spring strut 15 serves as both a locking member and a guide element and may be replaced by other means performing such a function as disclosed herein. The function of the spring struts may be performed separately by using different locking and guiding elements. It may be preferable to use two spring struts arranged opposite each other, but it is conceivable to use only one spring stanchion. When two or more spring struts are used, it is preferred that the spring struts are arranged symmetrically on the inner component.

The barrier member holder 18 is arranged at the second end 6 of the inner component 3. The elastic barrier member is generally made of a thermoplastic elastomer polymer material (TPE) so that the member can be attached to the barrier member holder by ultrasonic welding. However, other types of medical grade elastomeric materials may be used and the barrier member may be attached to the inner component by any means known to those of skill in the art. The barrier member holder 18 holds the barrier member 12 and further includes two radially opposed protrusions 19 arranged to cooperate with the corresponding grooves of the outer component 2 of the transfer connection device 1.

The first end 5 of the inner component 3 comprises a male connector 20 extending from the cylindrical body 14 of the inner component 3. The inside of the cylindrical body 14 of the inner component 3 includes an internal screw 21. The male connector and internal thread constitute a means for connecting to a mating medical device such as a catheter. It is understood that the particular connecting means referred to herein should not be considered limiting the invention and that other connecting means may be used depending on the medical device to which the transfer connecting device is mounted. I want to be.

As shown in FIG. 4, the outer component 2 of the transfer connection device 1 is provided with opposing grooves 22, which are formed on the inner wall 23 of the outer component 2 and with the corresponding protrusions 19 of the inner component 3. Arranged to form a bayonet fit. The locking projection 24 is arranged on the inner wall of the outer component 2 to keep the inner component 3 in a releasably locked state at the shielding position of the outer component 2. The guide track 25 that cooperates with the spring support 15 on the inner component 3 of the transfer connection device 1 is also arranged in the axial direction of the outer component 2. Within the scope of the present invention, alternative couplings between the outer component 2 and the inner component 3, such as screw couplings, may be used. Further, the locking projection 24 may be replaced by another locking element such as an elastically flexible locking tongue located on the wall of the outer component 2.

The spring strut 15 of the inner component 3 may be slightly curved inward in the radial direction when pushed inward. Although other configurations of guide elements and locking means other than those disclosed herein are conceivable within the scope of the invention, the advantage of the spring strut 15 disclosed herein is that the outer part 2 The transfer connection device 1 can be easily assembled by pushing the inner component 3 into the center hole 4 of the outer component 2 from the end opening 10 of the second end portion 9. The inner component 3 is pushed into the outer component 2 until the spring strut 15 passes the lock edge 26 of the wall 23 of the outer component 2. When the inner component 3 enters the outer component 2, the spring support 15 is first pressed radially and slightly curved to fit into the center hole 4 of the outer component 2. The tilted configuration of the spring column 15 helps guide the inner component 3 into the outer component 2. When pushed into a predetermined position inside the outer component 2, the contact surface 17 of the spring column 15 located directly below the lock edge 26 of the outer component 2 causes the spring column 15 to bounce back to a relaxed tension-free position. It is prohibited that the inner component 3 comes off from the outer component 2 and falls. The situation in which the spring strut 15 is located directly below the lock edge 26 is best shown in FIG. 9, where the barrier member 12 projects from the end opening 10 at the mouth of the center hole 4 of the outer component 2. It shows how the inner part 3 is arranged in a state where the second end 6 is positioned at the second end 9 of the outer part 2. As shown in FIGS. 8 and 9, the position of the inner component 3 in the outer component 2 corresponds to the cleaning position of the transfer connection device 1.

The inner component 3 is axially movable in the hole 4 of the outer component 2 between the shielding position and the cleaning position. Shielding positions are shown in FIGS. 1, 6, and 7, where the transfer connection device 1 is operational and can be used to connect two medical devices for transferring fluid between the devices "in use". It is also the position.

At the shielding position, the barrier member 12 is positioned in the hole 4 of the outer component 2 so that it is completely pulled into the outer component 2 of the transfer connection device 1 and is radially shielded and protected by the wall of the outer component 2. Will be done. When in the shielded position, the inner component is moved in relation to the outer component 2, and as shown in FIG. 1, the first end 5 of the inner component 3 is the first end 8 of the outer component and the outer component. The second end portion 6 of the inner component 3 is positioned at the first end portion 8 of the outer component 2 in a state of protruding from 2. This is because when the device 1 is in an operable shield position, the first end 5 of the inner component 3 forms the first end of the device 1 and the second end 9 of the outer component 2 It means forming an end portion of the device 1 on the opposite side in the second axial direction. In this configuration, the transfer connection device 1 is such that a catheter, vial, drip bag, intravenous injection device, or another medical coupling device, etc., by means of the male connector 20 and the internal thread 21 of the first end 5 of the inner component 3. It can be connected to a first medical device.

Depending on the type of inner component and the medical device coupled to the first end 5 of the device, the connecting means of the first end may differ from the male connector and internal thread shown. Therefore, as is known in the art, any type of screw coupling, bayonet fitting, snap lock, lock ring, slide fitting, clamp, etc. may be used. As shown in the illustrated embodiment, two or more locking elements of the same or different structure may be used in combination to create a bond between the connecting device 1 and the first medical device. A similar consideration applies to providing a coupling element that connects the opposite end of the connecting device 1 and the second medical device to the opposite end.

Once the transfer connection device 1 is connected to the first medical device, it may subsequently be connected to a second medical device that holds the puncture member. The second medical device is connected to the transfer connection device 1 at the second end of the outer component 2 and the transfer connection device 1. The second medical device may be a puncture device such as a syringe, another connecting device, or a needle protection device.

At the cleaning position, the barrier member 12 is formed by sliding the inner component 3 in the hole 4 of the outer component 2 until the contact surface 17 of the spring support 15 contacts the lock edge 26 at the opening of the outer component 2. Is moved to the second end 9 of the outer component 2. In the illustrated example, the barrier member is held in the cleaning position by frictional force. If desired, the device may be provided with one or more elements for releasably locking the barrier member to the cleaning position. Such a locking element may be a locking tongue, a locking projection, a locking edge, or the like, as is known in the art. At the cleaning position, the barrier member 12 is positioned at least partially outside the outer component 2 of the transfer connection device 1 in the axial direction A of the transfer connection device 1, and is returned to a shielding position where the transfer connection device 1 can operate. Can be easily cleaned before.

Further modifications of the invention within the scope of the claims will be apparent to those skilled in the art. For example, the locking and guiding mechanisms disclosed herein may be designed and configured differently without departing from the present invention.

Claims (13)

The first medical device is a medical transfer connection device (1) for connecting to a second medical device including a puncture member .
It comprises an outer component (2) having a first end (8), a second end (9) with an end opening (10), and
The inner part (3) holding the barrier member (12) and having the central tube (7) is nested in the outer part (2).
The barrier member (12) extends to the central canal (7) and seals the central canal (7).
The inner component (3) having the barrier member (12) has a shielding position in which the barrier member (12) is positioned on the outer component (2) in the outer component (2), and the barrier member (12). ) Is axially movable with and from the cleaning position where the barrier member (12) is positioned in a state where at least a part of the outer component (2) extends axially past the end opening (10) of the outer component (2). Yes,
When the barrier member (12) is in the shielding position, the end opening (10) opens to accept one of the first medical device and the second medical device.
The first end (5) of the inner component (3) forms the first end of the medical transfer connection device (1).
The second end (9) of the outer component (2) forms the second end (9) of the medical transfer connection device (1).
After the first end (5) is connected to the first medical device, the second end (9) can be connected to the second medical device .
Before Symbol medical transport connection device has an axial (A),
The outer component (2) has a hole (4) extending in the axial direction between the first end portion (8) and the second end portion (9).
The barrier member (12) is movable in the axial direction in the hole (4).
At the shielding position, the barrier member (12) is completely positioned in the hole (4) of the outer component (2).
The medical transfer connection device has an axial direction (A) and has an axial direction (A).
The central tube (7) of the inner component (3) extends in the axial direction (A).
The outer component (2) has a locking edge installed in the opening of the outer component (2).
The inner component (3) has a spring strut (15) having a contact surface (17).
When the barrier member (12) is in the cleaning position, the contact surface (17) of the spring column (15) is in contact with the lock edge and is located directly below the lock edge. Medical transport connection device. The outer component (2) comprises at least one axially extending groove (22, 25).
The inner component (3) is provided with means (15, 19) for slidingly engaging with the at least one groove (22, 25) in the outer component (2). The medical transfer connection device according to 1. The medical transfer connection device according to claim 2, wherein the means for slidingly engaging with at least one groove (25) includes a spring support (15). The spring strut (15) extends toward the second end (6) of the inner component (3) and is slightly outward with respect to the central axis (16) passing through the medical transfer connection device (1). The medical transfer connection device according to claim 3, wherein the medical transfer connection device is tilted. The medical transfer connection device according to claim 2, 3, or 4, wherein the means for slidingly engaging with at least one groove (22) includes a protrusion (19). A claim characterized in that the groove (22) and the protrusion (19) form a bayonet fit between the outer component (2) and the inner component (3) of the medical transfer connection device (1). Item 5. The medical transfer connection device according to item 5. The medical transfer connection device according to any one of claims 1 to 6, wherein the medical transfer connection device includes means (24) for releasably locking the inner component (3) to the shielded position. Medical transport connection device. The medical transfer connection device according to claim 7, wherein the means for locking the inner component to the shielding position so as to be releasable is a lock projection (24). The medical transfer according to any one of claims 1 to 8, wherein the medical transfer connection device includes means for releasably locking the inner component (3) to the cleaning position. Connection device. The medical treatment according to any one of claims 1 to 9, wherein the medical transfer connection device (1) includes connecting means (20, 21) for connecting to the first medical device. Transfer connection device for. The medical transport connection device (1) is a medical transport connection device according to any one of claims 1 to 10, wherein the obtaining Bei connection means for connecting to said second medical instrument .. The medical transfer connection device according to claim 10, wherein the inner component (3) includes connecting means (20, 21). The medical transfer connection device according to claim 12, wherein when the barrier member (12) is in the cleaning position, the connection means (20, 21) is positioned on the outer component (2). ..