JP2022123978A - Connection tube and priming method for medical device - Google Patents

Abstract

To provide a connection tube capable of priming a plurality of devices simultaneously and a priming method for a medical device.SOLUTION: A connection tube 50 for injecting fluid into a medical device 10 equipped with a first device 11 having a first lumen 24, a second device 12 having a second lumen 34, and a third device 13 having a third lumen 44 and a fourth lumen 45 includes a tube body 51 whose tip part is positioned in the first lumen 24 through the third lumen 44, and whose base end part is positioned outside the third device 13. The tube body 51 includes a base end opening 52 into which a second shaft part 30 can be inserted, a tip opening 53 communicated with the first lumen 24, a fluid inlet 54 positioned outside the third device 13, to which a fluid supply part can be connected, a fluid outlet 55 positioned in the third lumen 44, which is communicated with the fourth lumen 45, and a division start part 56 for dividing the tube body 51 in a circumferential direction from the base end part.SELECTED DRAWING: Figure 3

Description

TECHNICAL FIELD The present invention relates to a connection tube capable of connecting a plurality of medical devices and injecting a fluid into a lumen of each device, and a method of priming the medical device.

Some medical devices use a combination of multiple devices. For example, a guiding catheter for lower extremities uses a combination of a dilator inserted into the lumen of the guiding catheter and a Y connector having a hemostasis valve in order to support passage of the catheter through the blood vessel. The guiding catheter, dilator and Y-connector are packaged in the same bag.

When using a medical device, priming is performed to prevent backflow and clotting of blood. Patent Literature 1 discloses a Y connector provided with a valve to improve operability during priming.

JP-A-2000-334047

A medical device that uses a combination of multiple devices requires priming of each device, which takes time to prepare.

SUMMARY OF THE INVENTION The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a connecting tube and a method for priming medical devices that can prime a plurality of devices at the same time.

A connection tube according to the present invention for achieving the above object includes a tubular first shaft portion, and a first hub provided at a base end portion of the first shaft portion, and a connecting tube from the first shaft portion to the first shaft portion. a first device having a first lumen spanning a hub; a second shaft portion tubular and insertable into the first lumen; and a second hub at a proximal end of the second shaft portion; A second device comprising a second device having a second lumen extending from said second shaft portion to said second hub, and a mounting portion attached to said first hub, one communicating with said first lumen and the other open. A connecting tube for infusing a liquid into a medical device, comprising: a third device having three lumens and a fourth lumen branching radially from the third lumen, a tube body inserted and having a distal end located in the first lumen via the third lumen and a proximal end located outside the third device, the tube body being connected to the second shaft; a distal opening having an inner diameter smaller than the proximal opening and communicating with the first lumen; and a fluid external to the third device and capable of connecting a fluid supply. It has an inlet portion, a fluid outlet portion located in the third lumen and communicating with the fourth lumen, and a split start portion for splitting the tube body circumferentially from the proximal end portion.

A method for priming a medical device according to the present invention for achieving the above object comprises a tubular first shaft portion and a first hub provided at a proximal end portion of the first shaft portion, and a first device having a first lumen spanning said first hub; a second shaft portion tubular and insertable into said first lumen; and a second hub provided at a proximal end of said second shaft portion; a second device having a second lumen extending from said second shaft portion to said second hub; and a mounting portion attached to said first hub, one in communication with said first lumen and the other in communication with said first hub. A method of priming a medical device comprising: a third device having an open third lumen and a fourth lumen branching radially from the third lumen, the method comprising: a tube body; the tube body includes a proximal opening, a distal opening having an inner diameter smaller than the proximal opening, a fluid inlet, and a fluid outlet positioned proximal to the fluid inlet; a splitting start portion located at a proximal end portion; and a connecting tube having a split start portion located at a proximal end portion; 3 inserting from the device, positioning the tip in the first lumen of the first device and positioning the fluid outlet opposite the fourth lumen; and placing the second device in the base. a step of inserting into the tube body from an end opening and positioning a distal end proximal to the fluid inlet; into the first lumen of the device, from the proximal opening of the tubing body to the second lumen of the second device, and from the fluid outlet of the tubing body to the fourth lumen of the third device. , respectively injecting a fluid, advancing the second device so that the tip is positioned at the tip of the tube body, splitting the tube body from the split start part to split the tube body, and removing.

The connecting tube configured as described above can simultaneously prime the first lumen, the second lumen, the third lumen and the fourth lumen by injecting the fluid from the fluid inlet portion, and can be used for procedures using a medical device. can shorten the time required for the preparation of In addition, since the distal opening has a smaller inner diameter than the proximal opening, the linear velocity of the fluid from the fluid inlet is equal for both the first lumen and the second lumen, which has an inner diameter smaller than that of the first lumen. Therefore, both can be primed reliably and at the same timing. In addition, since the tube body has a splitting start portion, after priming, the tube body is torn and split in the circumferential direction for easy removal, and the dilator, which is the second device, is directly inserted into the guiding catheter, which is the first device. It can be fitted and used for catheter treatment.

An injection container filled with a fluid may be connected to the fluid inlet. As a result, it is not necessary to connect the infusion container to the connection tube, so the time required for priming can be shortened.

A port portion for connecting a fluid supply portion may be formed in the fluid inlet portion. As a result, the infusion container can be easily connected to the connecting tube, and the priming work can be facilitated.

The division start portion may be formed at a circumferential position different from the fluid inlet portion. Thereby, when dividing the tube main body in the circumferential direction, the fluid inlet portion can be prevented from hindering the division.

The distal opening may have an inner diameter less than or equal to the inner diameter of the second lumen. This prevents the linear velocity of the fluid flowing into the first lumen from becoming too large, and allows the priming of both the first device and the second device to be completed at approximately the same time.

The medical device priming method configured as described above can simultaneously prime the first device, the second device, and the third device that constitute the medical device, and can shorten the time required to prepare for a procedure using the medical device.

It is a front view of a connection tube, Comprising: It is the figure which represented the tube main body in the cross section. 1 is a front view of a first device, a second device, and a third device that constitute a medical device; FIG. FIG. 4 is a front view showing a state in which a connection tube is inserted with the third device attached to the first device, and the second device is inserted in the connection tube, and is a diagram showing a tube main body in cross section. FIG. 4 is a front view of a state in which fluid is injected into the connection tube from the state of FIG. 3 , and is a view showing the tube main body in cross section; FIG. 5 is a front view of a state in which the second device is advanced from the state of FIG. 4, showing a cross section of the tube body; FIG. 6 is a front view of a state in the middle of dividing the connection tube in the circumferential direction from the state of FIG. 5 , showing a cross section of the tube main body. FIG. 7 is a front view of a state in which the second device is further advanced from the state of FIG. 6; It is a front view of the connection tube which concerns on a modification.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may differ from the actual ratios.

A connection tube 50 according to an embodiment of the present invention enables a medical device 10 that uses a combination of multiple devices to be connected and primed simultaneously. In this specification, the side of the medical device 10 that is inserted into a biological lumen is referred to as the "distal end" or "distal side", and the proximal side of the medical device 10 that is operated is referred to as the "proximal end" or "proximal side". and

As shown in FIG. 1 , the connection tube 50 has a tubular tube body 51 . The tube main body 51 has a proximal end opening 52 and a distal end opening 53 that are open and communicate with each other. Distal opening 53 has a smaller inner diameter than proximal opening 52 . The connection tube 50 has a fluid outlet portion 55 that communicates with the inside on the proximal side of the distal end opening portion 53 . Further, the connection tube 50 has a fluid inlet portion 54 communicating with the inside on the proximal side of the fluid outlet portion 55 . The fluid inlet portion 54 is connected to an injection container 60 which is a fluid supply portion composed of a syringe. The inside of the injection container 60 is filled with a fluid, and the fluid inside can be injected into the connection tube 50 by pushing the injection operation part 61 . In this embodiment the fluid is saline. The fluid may also be heparinized saline or the like, and is not limited to saline.

The connecting tube 50 has a split start portion 56 for splitting the tube main body 51 in the circumferential direction from the base end portion. The division start portions 56 are arranged at two locations in the circumferential direction, and are each formed in a slit shape along the length direction of the tube main body 51 . The tube main body 51 is made of fluororesin. The material of the tube main body 51 is not limited to this, and may be, for example, a resin material such as a polyolefin resin such as polyethylene or polypropylene, or a silicone resin. Further, the tube main body 51 has a molecular structure that is oriented in one direction along the length direction. Such a tube main body 51 can be formed, for example, by extrusion molding a resin material. Therefore, the tube main body 51 can be easily split by hand along the length direction from the division start portion 56 . The division start portion 56 is formed at a circumferential position different from the fluid inlet portion 54 . Moreover, the division start portion 56 is not limited to a slit shape, and may be a groove shape or a notch shape.

As shown in FIG. 2, the medical device 10 is connected to the first device 11, which is a guiding catheter for lower extremities, the second device 12, which is a dilator inserted into the first device 11, and the first device 11. and a third device 13 which is a Y connector.

The first device 11 comprises a tubular first shaft portion 20 and a first hub 22 provided at the proximal end of the first shaft portion 20 . The first device 11 has a first lumen 24 extending from the first shaft portion 20 to the first hub 22 .

The second device 12 comprises a tubular second shaft portion 30 and a second hub 32 provided at the proximal end of the second shaft portion 30 . The second shaft portion 30 has an outer diameter that allows it to be inserted into the first lumen 24 of the first device 11 . The second device 12 has a second lumen 34 extending from the second shaft portion 30 to the second hub 32 .

The third device 13 has an attachment portion 41 attached to the first hub 22 on one side of the body portion 40 and an opening portion 42 on the other side of the body portion 40 . The third device 13 has a third lumen 44 continuous from the body portion 40 to the mounting portion 41 . The second shaft portion 30 of the second device 12 can pass through the third lumen 44 . A hemostasis valve 46 is provided at the proximal end of the third lumen 44 .

The third device 13 has a branch 43 extending radially into the third lumen 44 . The branching portion 43 has a fourth lumen 45 that branches radially from the third lumen 44 and communicates with the third lumen 44 . A three-way stopcock 47 is provided at the tip of the branch portion 43 .

A method of priming the medical device 10 using the connecting tube 50 will now be described. The operator attaches the attachment portion 41 of the third device 13 to the first hub 22 of the first device 11 in advance so that the first lumen 24 and the third lumen 44 are in communication. As shown in FIG. 3, the operator inserts the tube body 51 of the connection tube 50 from the opening 42 of the third device 13 toward the distal side. The operator inserts the tube body 51 until the tube body 51 passes through the hemostatic valve 46 of the third device 13 and the tip of the tube body 51 is positioned in the first lumen 24 of the first device 11 . In this state, the tip opening 53 of the tube main body 51 is located in the first lumen 24, the fluid outlet 55 of the tube main body 51 faces the fourth lumen 45, and the fluid inlet 54 of the tube main body 51 is located at the base. The end opening 52 is located outside the third device 13 .

The operator inserts the second shaft portion 30 of the second device 12 from the proximal end opening 52 of the connecting tube 50 to the distal side. The second shaft portion 30 is inserted so that the distal end 30 a is positioned closer to the proximal side than the fluid inlet portion 54 of the tube main body 51 .

When the operator presses the injection operation part 61 of the injection container 60 , the fluid filled in the injection container 60 is injected into the tube main body 51 . The fluid injected into the tube main body 51 flows to the distal end side and the proximal end side of the tube main body 51 respectively. As shown in FIG. 4 , the fluid F<b>1 that has flowed to the proximal side of the tube body 51 enters the second lumen 34 of the second device 12 that communicates with the proximal side of the tube body 51 . Some of the fluid F3 that has flowed to the distal end side of the tube main body 51 enters the third lumen 44 and the fourth lumen 45 of the third device 13 through the fluid outlet portion 55 . Also, part of the fluid F4 of the fluid F2 enters the first lumen 24 of the first device 11 through the tip opening 53 .

Since the distal end opening 53 of the tube body 51 has an inner diameter smaller than the proximal end opening 52, the linear velocity of the fluid F4 entering the first lumen 24 can be adjusted appropriately. The tip opening 53 is preferably equal to or less than the inner diameter of the second lumen 34 of the second device 12 . This ensures that the linear velocities of fluid F4 entering first lumen 24 and fluid F1 entering second lumen 34 are equal and both first lumen 24 and second lumen 34 are primed simultaneously. can do.

Thus, the connection tube 50 allows the first device 11 , the second device 12 and the third device 13 to be primed simply by injecting fluid from the injection container 60 into the connection tube 50 .

After priming, the operator advances the second device 12 to position the distal end 30a of the second shaft portion 30 at the distal end portion of the tube main body 51, as shown in FIG. At this time, the distal end 30 a of the second shaft portion 30 is positioned inside the third lumen 44 . Then, as shown in FIG. 6, the operator manually splits the connection tube 50 from the split start portion 56 to split it in the circumferential direction. Since the division start portion 56 is arranged at a position in the circumferential direction different from that of the fluid inlet portion 54, when dividing the tube main body 51 in the circumferential direction, the division can be prevented from being hindered by the fluid inlet portion 54. . The distal end portion arranged in the third lumen 44 and the first lumen 24 of the tube body 51 can also be divided while being pulled out of the third device 13 .

The tip of the tube main body 51 tapers toward the tip in order to reduce the inner diameter of the tip opening 53 . As the tube main body 51 is pulled out of the third device 13, this portion may be pushed radially from the distal end 30a of the second shaft portion 30, making it easier to split.

After dividing and removing the tube main body 51, the operator further advances the second device 12 to a position where the second hub 32 contacts the main body portion 40 of the third device 13 as shown in FIG. A procedure is performed using the device 10 .

In this way, after priming, the connecting tube 50 can be manually torn and removed, so the operator can proceed to the procedure with the medical device 10 primed, thereby shortening the time required for preparation for the procedure. be able to.

As shown in FIG. 8 , the connection tube 70 according to the modification has a port portion 71 to which the infusion container 60 can be connected as the fluid inlet portion 54 . As described above, the injection container 60 may be connected to the connection tube 50 in advance, or the injection container 60 may be attached to the connection tube 70 later, as shown in FIG. In this case, the fluid inlet portion 54 may have the port portion 70 or may have a through hole into which the tip of the injection container 60 can be inserted.

As described above, the connection tube 50 according to the present embodiment includes the tubular first shaft portion 20 and the first hub 22 provided at the base end portion of the first shaft portion 20. a first device 11 having a first lumen 24 extending from the first hub 22; a second shaft portion 30 tubular and insertable into the first lumen 24; a second device 12 comprising a second hub 32 and having a second lumen 34 extending from the second shaft portion 30 to the second hub 32; A medical device comprising a third lumen 44 communicating with one lumen 24 and the other being open, and a fourth lumen 45 radially branching from the third lumen 44. 10 is inserted from the third device 13, the distal end is located in the first lumen 24 via the third lumen 44, and the proximal end is in the third device 13. An externally positioned tube body 51 is provided, the tube body 51 having a proximal opening 52 into which the second shaft portion 30 can be inserted, and having an inner diameter smaller than the proximal opening 52 and communicating with the first lumen 24 . a distal opening 53, a fluid inlet 54 located outside the third device 13 to which a fluid supply can be connected, a fluid outlet 55 located in the third lumen 44 and communicating with the fourth lumen 45, and a base. and a division start portion 56 for circumferentially dividing the tube body 51 from the end portion. The connection tube 50 configured in this manner can simultaneously prime the first lumen 24, the second lumen 34 and the fourth lumen 45 by injecting the fluid from the fluid inlet portion 54, thereby enabling a procedure using the medical device 10 to be performed. can shorten the time required for the preparation of Also, since the distal opening 53 has a smaller inner diameter than the proximal opening 52 , the fluid from the fluid inlet 54 will not flow through both the first lumen 24 and the second lumen 34 , which has a smaller inner diameter than the first lumen 24 . By making the linear velocities of both the same, both can be primed almost simultaneously and reliably. Further, since the tube main body 51 has the division start portion 56, the tube main body 51 can be torn and divided in the circumferential direction after priming, and can be easily removed.

An injection container filled with fluid may be connected to the fluid inlet section 54 . As a result, it is not necessary to connect the fluid supply unit to the connection tube 50, so the time required for priming can be further shortened.

A port portion 71 for connecting a fluid supply portion may be formed in the fluid inlet portion 54 . Thereby, the injection container 60 can be easily connected to the connection tube 70, and the priming work can be facilitated.

The division start portion 56 may be formed at a circumferential position different from that of the fluid inlet portion 54 . Accordingly, when dividing the tube main body 51 in the circumferential direction, the fluid inlet portion 54 can be prevented from hindering the division.

Distal opening 53 may have an inner diameter equal to or less than the inner diameter of second lumen 34 . This prevents the linear velocity of the fluid flowing into the first lumen 24 from becoming too large, and allows the priming of both the first device 11 and the second device 12 to be completed almost simultaneously.

A method for priming a medical device 10 according to this embodiment includes a tubular first shaft portion 20 and a first hub 22 provided at the proximal end portion of the first shaft portion 20 , and A first device 11 having a first lumen 24 across the first hub 22 , a second shaft portion 30 tubular and insertable into the first lumen 24 , and a second shaft portion 30 provided at the proximal end of the second shaft portion 30 . a second device 12 having a second lumen 34 extending from the second shaft portion 30 to the second hub 32; and an attachment portion 41 attached to the first hub 22, one of which is the first A medical device 10 comprising a third device 13 having a third lumen 44 communicating with the lumen 24 and open on the other side, and a fourth lumen 45 branching radially from the third lumen 44. comprising a tube body 51 having a proximal opening 52, a distal opening 53 having an inner diameter smaller than the proximal opening 52, and a fluid inlet. 54, a fluid outlet portion 55 located proximal to the fluid inlet portion 54, and a split start portion 56 located proximally; With the third device 13 attached to the first hub 22, the tip of the tube body 51 is inserted from the third device 13, the tip is positioned in the first lumen 24 of the first device 11, and the fluid outlet 55 is inserted. and inserting the second device 12 into the tube body 51 through the proximal opening 52 and positioning the distal end proximal to the fluid inlet 54; , the fluid is injected from the fluid inlet portion 54 , from the distal opening 53 of the tube body 51 to the first lumen 24 of the first device 11 , from the proximal opening 52 of the tube body 51 to the second interior of the second device 12 . injecting fluid into cavity 34 from fluid outlet 55 of tube body 51 to fourth lumen 45 of third device 13 ; and splitting the tube body 51 from the split start portion 56 to remove the tube body 51 . The priming method for the medical device 10 configured in this manner can simultaneously prime the first device 11, the second device 12, and the third device 13 that constitute the medical device 10, thereby shortening the time required to prepare for a procedure using the medical device 10. can.

The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical concept of the present invention.

10 medical device 11 first device 12 second device 13 third device 15 infusion container 20 first shaft portion 22 first hub 24 first lumen 30 second shaft portion 30a tip 32 second hub 34 second lumen 40 main body Part 41 Mounting Part 42 Opening 43 Branching Part 44 Third Lumen 45 Fourth Lumen 46 Hemostasis Valve 47 Three-Way Stopcock 50 Connection Tube 51 Tube Body 52 Base End Opening 53 Distal Opening 54 Fluid Inlet 55 Fluid Outlet 56 Division start part 60 Injection container 61 Injection operation part

Claims (6)

a first device comprising a first tubular shaft portion and a first hub disposed at a proximal end of the first shaft portion and having a first lumen extending from the first shaft portion to the first hub; ,
a second shaft portion that is tubular and is insertable into the first lumen; and a second hub provided at a proximal end of the second shaft portion; a second device having a lumen;
a third lumen having an attachment portion attached to the first hub, one of which communicates with the first lumen and the other of which is open; and a fourth lumen branching radially from the third lumen. a third device comprising
A connecting tube for infusing a liquid into a medical device comprising
a tube body inserted from the third device, a distal end located in the first lumen via the third lumen, and a proximal end located outside the third device;
The tube body has a proximal opening into which the second shaft portion can be inserted, a distal opening having an inner diameter smaller than that of the proximal opening and communicating with the first lumen, and an external portion of the third device. a fluid inlet portion positioned and capable of connecting to a fluid supply; a fluid outlet portion positioned in the third lumen and communicating with the fourth lumen; A connecting tube having a split start. 2. The connection tube according to claim 1, wherein said fluid inlet is connected to an injection container filled with fluid. 2. The connection tube according to claim 1, wherein the fluid inlet portion is formed with a port portion for connecting a fluid supply portion. The connection tube according to any one of claims 1 to 3, wherein the division start portion is formed at a circumferential position different from the fluid inlet portion. The connection tube according to any one of claims 1 to 4, wherein the tip opening has an inner diameter equal to or smaller than the inner diameter of the second lumen. a first device comprising a first tubular shaft portion and a first hub disposed at a proximal end of the first shaft portion and having a first lumen extending from the first shaft portion to the first hub; ,
a second shaft portion that is tubular and is insertable into the first lumen; and a second hub provided at a proximal end of the second shaft portion; a second device having a lumen;
a third lumen having an attachment portion attached to the first hub, one of which communicates with the first lumen and the other of which is open; and a fourth lumen branching radially from the third lumen. a third device comprising
A method of priming a liquid for infusing a medical device comprising:
A tube body having a proximal opening, a distal opening having an inner diameter smaller than the proximal opening, a fluid inlet, and a fluid outlet located proximal to the fluid inlet. and a split start located at the proximal end;
With the third device attached to the first hub of the first device, the tip of the tube body is inserted from the third device, and the tip is positioned in the first lumen of the first device. and positioning the fluid outlet opposite the fourth lumen;
inserting the second device into the tube body through the proximal opening, with the distal end located proximal to the fluid inlet;
A fluid is injected from the fluid inlet, from the distal opening of the tube body into the first lumen of the first device, and from the proximal opening of the tube body into the second interior of the second device. injecting fluid into a lumen, respectively, from the fluid outlet of the tube body to a fourth lumen of the third device;
advancing the second device so that the tip is positioned at the tip of the tube body;
splitting the tube body from the split initiation portion to remove the tube body;
A method of priming a medical device comprising:

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