JP2014100303A - Balloon unit for hemostasis - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon unit which can quickly stop bleeding in a uterus without creating a risk of an infectious disease.SOLUTION: A balloon unit 1 for hemostasis includes a balloon catheter 2 for hemostasis and a connector cover 3. A first terminal 25 communicating with a first passage and a second terminal 27 communicating with a second passage are connected with a proximal end portion of a tube 21 of the balloon catheter 2 for hemostasis while branching at a first angle α. A base portion of at least one of the first terminal 25 and the second terminal 27 is constituted to have flexibility to be bendable. The connector cover 3 has terminal storage parts 31, 32 configured to be able to store the first terminal 25 and the second terminal 27 while the first and second terminals are bent in such a manner to form a second angle β that is a sharper angle.

Description

  The present invention relates to a hemostatic balloon unit for performing compression hemostasis when bleeding occurs in the uterus.

  Conventionally, a hemostasis balloon catheter used for hemostasis of a puncture site in esophageal varices sclerotherapy or the like is known (for example, see Non-Patent Document 1).

  The hemostasis balloon catheter includes a hemostasis balloon near the distal end of a tube made of a flexible resin, and a connector at the proximal end. Since the tube needs to discharge body fluid to the outside of the body, the first passage is communicated in the long axis direction from the drainage hole at the distal end portion, and the tube is extended from the hemostasis balloon to expand the hemostasis balloon. A second passage is communicated in the direction. In the connector, a first terminal communicated with the first passage and a second terminal communicated with the second passage are branched in a Y shape.

  The hemostasis balloon catheter can also be used for compression hemostasis when a predetermined amount or more of bleeding occurs in the uterus during delivery. Specifically, the hemostasis balloon is inserted from the vagina and placed in the womb, and then air or water is injected into the balloon to inflate the balloon to squeeze and stop the bleeding.

Machine instrument (51) Medical fistula and body fluid guide tube Management medical device Hemostasis balloon for esophageal varices sclerotherapy Top hemostasis balloon JMDN70234000 (Variocascuff: balloon for hemostasis)

  However, in the hemostasis method, the hemostasis balloon and the hemostasis tube pass through the vagina, which is an unclean area, and are inserted into the uterus, which is a clean area. There is a problem that the risk of infection may arise.

  In addition, the method of inserting the hemostatic balloon into the uterus via the vagina has a problem that it takes time to complete the hemostasis.

  SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a hemostatic balloon unit that eliminates such inconvenience and can quickly stop bleeding in the uterus without causing a risk of infection.

  In order to achieve this object, the present invention provides a hemostasis balloon catheter in which a hemostasis balloon is provided at the distal end portion of a flexible tube, and a connector is provided at the proximal end portion of the tube, and the hemostasis A hemostasis balloon unit comprising a connector cover detachably attached to a proximal end portion of a balloon catheter, wherein the tube has a first passage opened therein at a distal end side with respect to the hemostasis balloon. A second passage communicating with the hemostasis balloon, wherein the connector communicates with the first passage and a first angle from a base portion of the first terminal communicating with the second passage. And at least one base portion of the first terminal and the second terminal is flexible so that it can be bent, and the connector Takaba is characterized in that it comprises the terminal accommodating portion and the first terminal and the second terminal is stowable configured in a state of being bent such that the acute second angle than the first angle.

  As a result of diligent research, the inventor has inserted a hemostasis balloon catheter connector into the uterus from the incised portion of the patient who has undergone a caesarean section, and takes the connector out of the patient's body through the vagina, and the hemostasis balloon is inserted into the uterus. I found a way to place it inside.

  However, since the conventional balloon catheter for hemostasis has a pair of terminals, the middle of the tube branches off in a Y-shape, so that the insertion resistance is large when the connector is placed from the incision through the vagina. There is.

  In this regard, in the hemostasis balloon unit of the present invention, since the base portion of at least one of the first terminal and the second terminal of the connector of the hemostasis balloon catheter has flexibility, the first terminal and the second terminal are used. The angle can be bent to a second angle that is more acute than the first angle. That is, the first terminal and the second terminal can be bundled close to each other.

  The connector cover of the hemostatic balloon unit according to the present invention is housed in the terminal housing portion in a state where the first terminal and the second terminal of the connector are bent at the second angle and close to each other (bundled). can do.

  As a result, according to the hemostatic balloon unit of the present invention, it is possible to reduce the insertion resistance when the connector is inserted from the incision portion of the patient who has undergone the caesarean section, and to prevent bleeding in the uterus from risk of infection. It is possible to stop bleeding quickly without causing any trouble.

  In the hemostasis balloon unit of the present invention, it is preferable that the connector cover includes a shape holding member that can be held in a deformed state.

  According to the hemostasis balloon unit having the above configuration, the shape of the connector cover can be deformed according to the patient, so that the insertion resistance when the connector is inserted can be further reduced, and hemostasis can be quickly performed. can do.

  Moreover, in the balloon unit for hemostasis of the present invention, the terminal storage portion of the connector cover is configured to be capable of being stored in a state where the first terminal and the second terminal are compressed from the second angle. Is preferred.

  According to the hemostasis balloon unit having the configuration, since the diameter of the hemostasis balloon unit can be further reduced, the insertion resistance when the connector is inserted can be further reduced, and the hemostasis can be stopped quickly. Can do.

  In the hemostasis balloon unit according to the present invention, the first passage and the first terminal are configured to be able to insert a stylet for maintaining the shape of the tube, and the connector cover is a base end of the stylet. It is preferable to have a stylet storage part that is configured to be able to fit a stylet handle that is fixed to the stylet or that is provided at the base end part of the stylet.

  In the hemostasis balloon unit having such a configuration, the connector covered with the connector cover can be disposed outside the body from the uterus through the vagina while the stylet is inserted through the first passage, thereby improving operability. it can. And since the stylet storage part of the said connector cover is fitted by the stylet handle with which the base end part of the said stylet was fitted, when removing the said connector cover, the said stylet is extracted together can do.

  As a result, according to the hemostasis balloon unit having such a configuration, the procedure time can be further shortened, so that hemostasis can be performed more quickly.

  Note that the base end of the stylet may be directly fixed to the connector cover without providing a stylet handle at the base end of the stylet. In addition, instead of configuring the first passage and the first terminal so that a stylet can be inserted, the third passage may be further configured to allow the stylet to be inserted.

The partial cross section figure of the balloon unit for hemostasis which made the connector cover sectional drawing. Illustration of balloon catheter for hemostasis Illustration of connector cover Illustration of connector cover usage Explanatory drawing of the 1st modification of a connector cover Explanatory drawing of the 2nd modification of a connector cover

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

  As shown in FIG. 1, the hemostatic balloon unit 1 of the present embodiment includes a hemostatic balloon catheter 2, a connector cover 3 that covers the proximal end portion of the hemostatic balloon catheter 2, and a stylet 4.

  As shown in FIG. 2, the hemostasis balloon catheter 2 includes a tube 21 having flexibility. A hemostatic balloon 23 is provided at the distal end portion of the tube 21, and a drainage hole 22 (opening) is formed on the distal end side of the hemostatic balloon 23. The distal end of the tube 21 is closed by a distal tip (not shown). The tip is made of a radiopaque material.

  In the present specification, the direction in which the left hemostasis balloon 23 is present as viewed in the drawing is referred to as the distal direction, and the direction in which the right connector 24 is present as viewed in the drawing is described as the proximal direction.

  The tube 21 is made of a synthetic resin such as polyvinyl chloride, silicone rubber, or thermoplastic elastomer. The tube 21 has three passages in the major axis direction: a first passage communicating with the drainage hole 22, a second passage communicating with the hemostatic balloon 23, and a third passage (all not shown).

  The connector 24 has a main port 25 (first terminal) and a balloon port 27 (second terminal) provided with a check valve 26. The main port 25 and the balloon port 27 are branched in a Y shape at an angle α (first angle).

  The connector 24 is made of a synthetic resin such as polyvinyl chloride, silicone rubber, or thermoplastic elastomer. Here, the main port 25 has a thickness of 1 to 6 mm. On the other hand, the base portion of the balloon port 27 branched from the main port 25 has a wall thickness of 1 to 6 mm, whereas the base end portion of the balloon port 27 (near the check valve 26) has a wall thickness of 1 to 3 mm. .

  The connector 24 is connected to the tube 21, the main port 25 communicates with the first passage, and the balloon port 27 communicates with the second passage.

  As a result, the first passage is configured such that liquid such as blood or cleaning liquid that has entered through the drainage hole 22 can be discharged from the main port 25 to the outside of the body.

  The second passage is configured so that the hemostatic balloon 23 can be inflated by supplying air or water from the balloon port 27. Conversely, in the second passage, the hemostasis balloon 23 is contracted by releasing the lock of the check valve 26 from the state in which the hemostasis balloon 23 is inflated and supplying air or water in the reverse direction. be able to.

  Furthermore, an X-ray opaque line such as barium sulfate is embedded in the third passage.

  As shown in FIG. 3A, the connector cover 3 is formed in a sheath shape with a curved middle part. The connector cover 3 is thinner in the proximal direction than in the distal direction in which the connector 24 is accommodated. Further, the base end portion of the connector cover 3 is formed in a round shape.

  The connector cover 3 is made of a synthetic resin such as polyvinyl chloride, silicone rubber, or thermoplastic elastomer. Although not shown, a mandrel (shape holding member) is embedded in the connector cover 3 along the long axis direction.

  As shown in FIG. 3B, the connector cover 3 is configured to accommodate the main port accommodating portion 31 configured to accommodate the main port 25 and the balloon port 27 as the terminal accommodating portion in the present invention. And a balloon port storage portion 32. Further, as shown in FIG. 3C, the connector cover 3 has a stylet storage portion 33 that communicates with the main port storage portion 31. The stylet storage portion 33 is configured to be fitted in a state in which a stylet handle 41 provided at a base end portion of the stylet 4 to be described later is stored. Furthermore, the connector cover 3 has a shape in which the base end side extends in a rod shape.

  Preparation for using the hemostatic balloon unit 1 of the present embodiment will be described.

  First, the stylet 4 is inserted into the first passage through the main port 25 of the hemostasis balloon catheter 2 until the distal end portion of the stylet handle 41 contacts the proximal end portion of the main port 25. At this time, the stylet 4 is designed to be slightly shorter than the hemostatic balloon catheter 2 so that the distal end of the stylet 4 does not protrude from the distal end of the hemostatic balloon catheter 2. In this embodiment, the stylet 4 can be inserted into the first passage. However, in addition to the first passage that also serves as a drainage, a separate passage may be provided exclusively for inserting the stylet 4.

  Next, as shown in FIG. 4A, the hemostasis balloon unit 1 is configured by covering the connector 24 with the connector cover 3 in a state where the stylet 4 is inserted into the hemostasis balloon catheter 2. . Specifically, the stylet handle 41 is stored in the stylet storage portion 33, the main port 25 is stored in the main port storage portion 31, and the balloon port 27 is stored in the balloon port storage portion 32.

  As described with reference to FIG. 2, in a normal state not covered with the connector cover 3, the main port 25 and the balloon port 27 are branched in a Y shape at an angle α. In this state, the main port 25 and the balloon port 27 cannot be simultaneously stored in the main port storage portion 31 and the balloon port storage portion 32 adjacent thereto. Therefore, when housing the connector 24 in the connector cover 3, the main port 25 is placed in the main port housing portion 31 and the balloon port 27 is placed in the balloon port housing portion 32 with the root portion of the balloon port 27 bent. Store each one. An angle of branching that is sharper than the angle α that enables the simultaneous storage is defined as an angle β (second angle).

  A specific method of using the hemostatic balloon unit 1 of the present embodiment will be described.

  First, a lubricant is applied to the entire hemostatic balloon unit 1. Then, a caesarean section is performed by an appropriate method for a patient whose bleeding from the uterus is confirmed. Next, the hemostatic balloon unit 1 is inserted from the portion (extension portion) extending in the shape of a rod on the proximal end side of the connector cover 3 into the cesarean section. Further, the hemostatic balloon unit 1 is inserted from the uterus through the vagina until the connector cover 3 comes out of the body.

  Next, by operating the connector cover 3 that has come out of the body, the position is adjusted so that the hemostatic balloon 23 enters the uterus.

  When the position adjustment is completed, the connector cover 3 is removed from the connector 24 as shown in FIG.

  At this time, since the stylet handle 41 is fitted in the stylet storage portion 33 of the connector cover 3, when the connector cover 3 is removed, the stylet handle 41 is also pulled at the same time, and the stylet 4 is connected to the second of the tube 2. It is pulled out from one passage.

  Next, using the X-ray opaque tip and X-ray opaque line, it is confirmed that the balloon is in the uterus. The hemostatic balloon 23 is inflated by supplying air or water from the balloon port 27.

  Next, if necessary, a drainage bag (not shown) is connected to the main port 25 and a necessary procedure is performed.

  Finally, after confirming hemostasis from the uterus, the gas or liquid is discharged from the hemostasis balloon 23 and contracted, and then the hemostasis balloon catheter 2 is removed from the connector 24 side.

  As described above, according to the hemostatic balloon unit 1 of the present embodiment, since it can be inserted from the womb that is a clean area into the vagina that is an unclean area, the risk of infection can be reduced. In addition, since the connector cover 3 has a portion (extension portion) extending in a rod shape on the proximal end side, the insertion operation from the uterus to the vagina can be performed very smoothly.

  Further, according to the hemostatic balloon unit 1 of the present embodiment, the connector 24 can be covered with the connector 24 after the Y-shaped branch of the connector 24 having the angle α is set to the angle β. The resistance can be reduced and hemostasis can be performed more quickly.

  Further, since the connector cover 3 of the hemostatic balloon unit 1 of the present embodiment has a curved middle abdomen, it can be easily inserted into the vagina from the uterus on the cesarean section side, and can be stopped more rapidly. it can. In addition, the connector cover 3 is thinner in the proximal direction than the distal direction in which the connector 24 is accommodated, and the proximal end portion is formed in a round shape. It is easy to insert and can stop bleeding more quickly.

  Further, the connector cover 3 can deform the middle abdominal curve with a mandrel (shape holding member) in accordance with the shape of the patient's uterus and vagina, so that the insertion resistance can be further reduced, and hemostasis can be rapidly performed. be able to.

  In addition, according to the hemostatic balloon unit 1 of the present embodiment, the connector can be placed outside the body from the uterus through the vagina while the stylet 4 is inserted through the first passage. Can stop bleeding quickly.

  According to the hemostasis balloon unit 1 of this embodiment, the position of the hemostasis balloon 23 can be adjusted using the X-ray impervious tip and the X-ray impermeability line. It can be set in the womb and can stop bleeding more quickly.

  Furthermore, according to the hemostasis balloon unit 1 of the present embodiment, when the connector cover 3 is removed from the connector 24, the stylet 4 can be removed from the first passage of the tube 2 at the same time. Since it can be shortened, hemostasis can be performed more quickly.

  The hemostatic balloon unit 1 of the present embodiment is mainly used when a patient who has undergone a caesarean section develops intrauterine hemorrhage. However, even in the case of hemorrhage at the time of delivery, the hemostatic balloon unit 1 is more rapid and more infectious than insertion via the vagina. Since hemostasis can be performed without risk, it is preferable to use the hemostatic balloon unit 1. Further, the hemostasis balloon unit 1 of the present embodiment can be used for a procedure of inserting into the uterus from the hemostasis balloon 23 side through the vagina as usual.

  A hemostatic balloon unit 11 according to a first modification of the present embodiment will be described with reference to FIG. In the hemostasis balloon unit 11, portions having the same configuration as that of the hemostasis balloon unit 1 described above will be described using the same reference numerals as before, and description of overlapping contents will be omitted.

  As shown in FIG. 5A, the connector cover 35 of the hemostatic balloon unit 11 is formed in a thin sheath shape having substantially the same diameter from the proximal direction to the distal direction.

  As shown in FIGS. 5B and 5C, the connector cover 35 includes a storage portion 36 configured to store the main port 25 and the balloon port 27.

  As shown in FIG. 5 (d), the hemostatic balloon unit 11 is configured by covering the connector 24 with the connector cover 35 in a state where the stylet 4 is inserted into the hemostatic balloon catheter 2. Specifically, the main port 25 and the balloon port 27 are stored in the storage unit 36.

  When the main port 25 and the balloon port storage portion 32 are stored in the storage portion 36, the main port 25 and the balloon port 27 are further compressed from the angle β where the root portion of the balloon port 27 is bent. Store in.

  According to the hemostatic balloon unit 11, since the diameter can be further reduced, the insertion resistance at the time of insertion from the uterus on the cesarean section to the vagina can be further reduced and rapid hemostasis can be achieved. it can.

  A hemostatic balloon unit 12 according to a second modification of the present embodiment will be described with reference to FIG. In the hemostasis balloon unit 12, portions having the same configuration as that of the hemostasis balloon unit 1 described above will be described using the same reference numerals as before, and description of overlapping contents will be omitted.

  As shown in FIG. 6 (a), the stylet 4 of the hemostatic balloon unit 12 is not provided with a stylet handle, and the connector cover 37 is not provided with a stylet storage. The base end portion of the stylet 4 is directly embedded and fixed on the rear end side surface of the main port storage portion 31 of the connector cover 37.

  As a result, according to the hemostatic balloon unit 12, when the connector cover 37 is removed from the connector 24 after reducing the number of parts, the stylet 4 is simultaneously attached to the tube 21 as shown in FIG. Since it can be extracted from the first passage, the procedure time can be further shortened, so that hemostasis can be performed more quickly.

  DESCRIPTION OF SYMBOLS 1,11,12 ... Balloon unit for hemostasis, 2 ... Balloon catheter for hemostasis, 3,35,37 ... Connector cover, 4 ... Stylet, 22 ... Drainage hole (opening), 21 ... Tube, 23 ... Balloon for hemostasis , 24 ... Connector, 25 ... Main port (first terminal), 27 ... Balloon port (second terminal), 31 ... Main port storage part, 32 ... Balloon port storage part, 33 ... Stylet storage part, 36 ... Storage part , 41 ... stylet handle, α ... first angle, β ... second angle.

Claims (5)

A hemostasis balloon is provided at the distal end of a flexible tube, and a hemostasis balloon catheter having a connector provided at the proximal end of the tube, and is detachably attached to the proximal end of the hemostasis balloon catheter. A balloon unit for hemostasis composed of a connector cover,
The tube includes therein a first passage that opens at a distal end side than the hemostatic balloon, and a second passage that communicates with the hemostatic balloon,
The connector includes a first terminal that communicates with the first passage, and a second terminal that communicates with the second passage and branches at a first angle from a root portion of the first terminal, and the first terminal; The at least one base portion with the second terminal is configured to be flexible by having flexibility,
The connector cover includes a terminal storage portion configured to be stored in a state in which the first terminal and the second terminal are bent so as to be at a second angle that is sharper than the first angle. A balloon unit for hemostasis. The hemostatic balloon unit according to claim 1,
The connector cover includes a shape-holding member that can be held in a deformed state. The hemostatic balloon unit according to claim 1 or 2,
The hemostasis balloon unit, wherein the terminal housing portion of the connector cover is configured to be housed in a state where the first terminal and the second terminal are compressed from the second angle. The hemostatic balloon unit according to any one of claims 1 to 3,
The first passage and the first terminal are configured so that a stylet for holding the shape of the tube can be inserted;
The connector cover has a stylet storage portion that is configured to be fitted with a stylet handle that is fixed to the base end of the stylet or that is provided at the base end of the stylet. Balloon unit. The hemostatic balloon unit according to any one of claims 1 to 3,
The tube includes a third passage configured to be able to insert a stylet for maintaining the shape of the tube,
The connector cover has a stylet storage portion that is configured to be fitted with a stylet handle that is fixed to the base end of the stylet or that is provided at the base end of the stylet. Balloon unit.

Images