JP7074354B2 - Medical tube connection device - Google Patents

Description

The present invention relates to a medical tube connecting device. More specifically, the present invention relates to a medical tube connecting device in which the flowing liquid does not come into contact with anything other than the medical tube during use.

For example, when using or exchanging a medical device such as an implant-type artificial dialysis device, it becomes necessary to connect artificial blood vessels to each other. In such a case, the artificial blood vessels are usually connected to each other by using a blood vessel connecting device (connector, tube contact device) provided at the tips of the two artificial blood vessels to be connected.

For example, Japanese Patent Application Laid-Open No. 2015-156935 describes a pipe fitting device.

JP-A-2015-156935

In the conventional pipe fitting device (blood vessel connecting device) represented by Japanese Patent Application Laid-Open No. 2015-156935, the patient's blood comes into contact with a portion other than the artificial blood vessel at the time of use. Then, there is a problem that blood coagulates and stenosis occurs in the artificial blood vessel. In addition, if there are many steps or protrusions in the blood flow path, there is a problem that the blood coagulates and causes stenosis in the artificial blood vessel. The conventional blood vessel connection device has a problem that the device becomes large because the mechanism for connecting artificial blood vessels is complicated.

Therefore, an object of the present invention is to provide a connecting device for a medical tube in which the flowing fluid does not come into contact with a portion other than the medical tube during use. Further, the present invention simplifies the mechanism for connecting medical tubes to each other, and provides a small-sized medical tube connecting device.

In the present invention, the ends of the two medical tubes are folded back so that the folded portions of the medical tubes can be pushed from both ends. By doing so, the portion through which the flowing liquid flows becomes inside the medical tube, and the flowing fluid does not come into contact with the portion other than the medical tube. Furthermore, even after the medical tubes are connected to each other, as a general rule, there is only one seam, so there is no step throughout and the flow path becomes smooth. Therefore, if this medical tube connecting device is used, it is possible to eliminate the stenosis of the medical tube due to the coagulation of the flowing liquid without disturbing the flow of the flowing liquid.

The medical tube connecting device of the present invention has two main elements (parts). The medical tube connecting device may have other elements (parts). Further, the two elements themselves may be composed of one element, or may have two or more parts. A part means an independent part or a removable part.

The first element 9 has a first fixed tube 5 that holds the end of the first medical tube 3 in a folded state, and a first case 7 that houses the first fixed tube 5.
The second element 19 has a second fixed tube 15 that holds the end of the second medical tube 13 in a folded state, and a second case 17 that houses the second fixed tube 15. The first case 7 can be inserted into the second case 17.
Then, in the state where the first element 9 and the second element 19 are combined, the first fixed tube 5 and the second fixed tube 15 are the end portion of the first medical tube 3 and the second medical treatment. By pushing the first medical tube 3 and the second medical tube 13 in the direction in which the end portions of the medical tubes 13 are joined, the first medical tube 3 and the second medical tube 13 are joined. ..

A preferred example of the first medical tube 3 and the second medical tube 13 is an artificial blood vessel.

A preferred example of the above connection device is
When the first element 9 and the second element 19 are in a combined state,
It further has a medical tube stabilizing tube 24 located between the inner circumferences of the first case 7 and the second case 17 and the outer circumferences of the first fixed tube 5 and the second fixed tube 15.

A preferred example of the connection device is that at least a part of the portion where the first medical tube 3 and the second medical tube 13 come into contact with the first element 9 and the second element 19 in combination. ， It is modified by ion implantation.

An example of how to use the medical tube connection device is as follows. This method includes a step of preparing the first element 9, a step of preparing the second element 19, and a step of joining the first element 9 and the second element 19. The order of the step of preparing the first element 9 and the step of preparing the second element 19 may come first. The first element 9 has a first fixed tube 5 and a first case 7 accommodating the first fixed tube 5. The second element 19 has a second fixed tube 15 and a second case 17 that houses the second fixed tube 15. The first case 7 may be inserted into the second case 17.

The process of preparing the first element 9 is
The step (S101) of passing the first medical tube 3 through the first case 7 and
A step of inserting the first medical tube 3 into the first fixed tube 5 through the inside of the first fixed tube 5 so that the end portion of the first medical tube 3 protrudes (S102).
The present invention includes a step (S103) of folding back the end portion of the first medical tube 3 protruding from the first fixed tube 5 in the outer peripheral direction of the first fixed tube 5.

The process of preparing the second element 19 is
The step (S201) of passing the second medical tube 13 through the second case 17 and
A step of inserting the second medical tube 13 into the second fixed tube 15 through the inside of the second fixed tube 15 so that the end portion of the second medical tube 13 protrudes (S202).
It has a step (S203) of folding back the end portion of the second medical tube 13 protruding from the second fixed tube 15 in the outer peripheral direction of the second fixed tube 15.

The step of connecting the first element 9 and the second element 19 is
Combining the first element 9 and the second element 19
The first fixed tube 5 and the second fixed tube 15 are connected to the first medical tube 3 in the direction in which the end of the first medical tube 3 and the end of the second medical tube 13 are joined to each other. It has a step (S401) in which the second medical tube 13 is pushed and the first medical tube 3 and the second medical tube 13 are coupled.

A preferred example of the above method of connecting a medical tube is
Before the step (S401) of joining the first element 9 and the second element 19.
The medical tube stabilizing tube 24 is located between the inner circumference of the first case 7 and the second case 17 and the outer circumference of the first fixed tube 5 and the second fixed tube 15 for medical use. Further, there is a step (S301) of inserting the first fixed tube 5 and the second fixed tube 15 into the tube stabilizing tube 24.

INDUSTRIAL APPLICABILITY The present invention can provide a connecting device for a medical tube in which the running fluid does not come into contact with a portion other than the medical tube during use. Further, the present invention simplifies the mechanism for connecting medical tubes to each other, and can provide a connection device for medical tubes having a small size.

FIG. 1 is a conceptual diagram showing an example of a cross section of the connecting device of the present invention. FIG. 2 is a conceptual diagram showing an example of the appearance of the connecting device of the present invention. FIG. 3 is an example of a member for folding back the first medical tube 3. FIG. 3A shows a columnar protrusion, and FIG. 3B shows a shape in which the protrusion has a gentle curve as it advances upward. FIG. 4 is a conceptual diagram showing the tip portion of the fixed tube. In the case shown in FIG. 4A, the tip of the fixed tube is rounded so as not to damage the medical tube. FIG. 4B has a flat portion at the tip of the fixed tube so that the medical tubes can be uniformly pressed against each other during use. The one shown in FIG. 4 (c) has a protrusion (with an apex) directed downward or diagonally downward at the tip of the fixed tube. FIG. 5 is a conceptual diagram for explaining a medical tube connecting device different from that of FIG. FIG. 6 is a conceptual diagram for explaining a medical tube connecting device different from that of FIG. FIG. 7 is a graph that replaces the drawing showing the relationship between the flow rate and the water pressure. FIG. 8 is an SEM photograph that replaces the drawing showing the connection portion after 1 hour. FIG. 9 is an SEM photograph that replaces the drawing showing the connection portion after 24 hours. FIG. 10 is an SEM photograph that replaces the drawing showing the connection portion after 48 hours. FIG. 11 is an SEM photograph that replaces the drawing showing the biological deposits when blood flows in for 48 hours.

Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. The present invention is not limited to the forms described below, and includes those modified appropriately by those skilled in the art from the following forms.

FIG. 1 is a conceptual diagram showing an example of a cross section of a connecting device for a medical tube of the present invention. FIG. 2 is a conceptual diagram for explaining an example of a component of a connecting device for a medical tube. As shown in FIG. 1, the present invention relates to a device for connecting a medical tube. In particular, the present invention relates to an artificial blood vessel connecting device (connector) for connecting an artificial blood vessel. The connecting device for connecting the medical tubes is a medical device for connecting two medical tubes. Examples of medical tubes are artificial blood vessels, fluid circulation tubes implanted in the body, perfusion tubes and blood vessels. A preferred example of a medical tube among these is an artificial blood vessel.

The medical tube connecting device of the present invention has two main elements (parts). The medical tube connecting device may have other elements (parts). Further, the two elements themselves may be composed of one element, or may have two or more parts. A part means an independent part or a removable part.

The first element 9 has a first fixed tube 5 that holds the end of the first medical tube 3 in a folded state, and a first case 7 that houses the first fixed tube 5. The first fixed tube 5 may be coupled to the first case 7, or the first fixed tube 5 may be accessible but in contact with the first case 7.
The second element 19 has a second fixed tube 15 that holds the end of the second medical tube 13 in a folded state, and a second case 17 that houses the second fixed tube 15. The second case 17 may have a smaller diameter than the first case 7 and may be inserted into the first case 7. The second case 17 may be inserted into the first case 7 to combine them. Further, for example, when these have the same diameter, the end portion of the first case and the end portion of the second case may be connected to each other. Then, for example, in a state where the second case 17 is inserted into the first case 7 and the first element 9 and the second element 19 are combined, the first fixed tube 5 and the second fixed tube are combined. When the 15 pushes in the direction in which the end of the first medical tube 3 and the end of the second medical tube 13 are joined, the first medical tube 3 and the second medical tube 13 are brought into contact with each other. Join.

An example of the first fixed tube 5 is a tubular one (a cylindrical one with an empty inside). The first fixed tube 5 houses, for example, a medical tube inside the fixed tube 5. Therefore, the first fixed tube 5 may have an inner diameter that is the same as the outer diameter of the medical tube or slightly larger (slightly smaller) than the outer diameter of the medical tube. When the inner diameter of the first fixed tube 5 is d _ST1 and the outer diameter of the medical tube is d _AV , the example of d _ST1 is 0.9d _AV or more and 1.1d _AV or less, and 0.95d _AV or more and 1 It may be 0.05d _AV or less, 1d _AV or more and 1.1d _AV or less, or 1d _AV or more and 1.05d _AV or less.

The first fixed tube 5 supports the medical tube during use and pressurizes the connection portion of the medical tube. Therefore, the first fixed tube 5 preferably has a certain level of strength and rigidity. The first fixed tube 5 may be made of, for example, metal (for example, iron, copper, stainless steel, aluminum, or alloy). Since the first fixed tube 5 does not come into contact with running fluid such as blood or plasma, the degree of freedom of the material is high. The thickness and length of the first fixed tube 5 may be appropriately adjusted according to the intended use. An example of the thickness of the first fixed tube 5 is 0.5 mm or more and 3 mm or less.

One end (open end) of the first fixed tube 5 holds the medical tube as described above, and pressurizes the medical tube when the device is used. The other end (fixed end) of the first fixed tube 5 may be fixed to the ring-shaped side wall of the first case 7, or may receive a repulsive force from the ring-shaped wall of the first case 7. It is preferable to be done. The first case 7 has a ring-shaped side wall existing around a hole through which a medical tube is passed, and a hole 25 for accommodating a first cylindrical portion 27 and a protrusion 23 constituting the outer circumference. The fixed end of the first fixed tube 5 comes into contact with the inner surface of the side wall of the first case 7. An example of the outer diameter (diameter) d _T1 of the first cylindrical portion 27 is 4 mm or more and 20 mm or less, 5 mm or more and 12 mm or less, 6 mm or more and 15 mm or less, 2 mm or more and 5 mm or less, and 10 mm or more and 30 mm. It may be less than or equal to, and may be 2 mm or more and 30 mm or less. Since this connecting device has a simple mechanism, the size of the device can be reduced.

The first fixed tube 5 holds the end of the first medical tube 3 in a folded state. As shown in FIG. 1, the end portion of the first medical tube 3 protrudes from the first fixed tube 5, and the protruding portion is folded along the first fixed tube 5 to form the first. It is folded back along the outer circumference of the fixed pipe 5 to the middle portion of the first fixed pipe 5. FIG. 3 is an example of a member for folding back the first medical tube 3. The folding device has a stage 31 and a protrusion 33 provided on the stage 31 (for example, in the center of the stage). FIG. 3A shows a columnar protrusion 33, and FIG. 3B shows a shape in which the protrusion 33 has a gentle curve so that the diameter becomes larger as it approaches the stage 31 side. Is. By pressing the folding device so that the protrusion 33 is inserted into the first medical tube 3 protruding from the first fixed tube 5, the first fixed tube 5 of the first medical tube 3 is pressed. The protruding portion is folded along the first fixed tube 5, and further folded back along the outer periphery of the first fixed tube 5 to the middle portion of the first fixed tube 5. The present invention also provides a medical tube connection kit having the above-mentioned medical tube connection device and a folding device.

FIG. 4 is a conceptual diagram showing the tip portion of the fixed tube. In the case shown in FIG. 4A, the tip of the fixed tube (at least the open end for holding the medical tube) is rounded so as not to damage the medical tube. FIG. 4B has a flat portion at the tip of the fixed tube so that the medical tubes can be uniformly pressed against each other during use. Even in this case, the corners of the fixed tube may be chamfered. The one shown in FIG. 4 (c) has a protrusion (with an apex) directed downward or diagonally downward at the tip of the fixed tube. When connecting medical tubes together, a dent may occur at the connection. The end shown in FIG. 4 (c) is for canceling the dent. FIG. 4C is an exaggerated drawing, and the height of the protrusion may be slight, or a large protrusion may be present at the tip of the fixed tube.

The second fixed pipe 15 is the same as the first fixed pipe 5.

The first case 7 may have a first cylindrical portion 27 corresponding to an outer portion. Further, in the first case 7, there may be a hole 25 in which the first tubular portion 27 is cut out. When the protrusion 23 is present in the second case 17, the hole 25 may correspond to the shape of the protrusion. The first fixed tube 5 may be designed to be concentric circles (circles having the same center) of the first cylindrical portion 27. Of the side surfaces of the first case 7, the surface that does not match the second case 17 may have a ring shape. A medical tube will pass through the center of this surface. The first fixed tube 5 is preferably shorter in length than the first tubular portion 27.

Examples of the materials of the first case 7 and the second case 17 are made of resin. Since the first case does not come into contact with flowing fluid such as blood, the degree of freedom of the material is high.

The second case 17 accommodates the second fixed tube 15. The second case 17 has a tubular portion 21 having a protrusion 23 and a ring-shaped annular portion existing at the tip of the tubular portion and having a hole for passing a medical tube. For example, when the protrusion 23 is pushed from the outside of the second case 17, the protrusion 23 lowers downward, and when the pushing force is weakened, the protrusion 23 returns to the original position. The outer circumference of the tubular portion 21 of the second case 17 is adapted to fit within the inner circumference of the first case 7. That is, the diameter of the outer circumference of the tubular portion 21 of the second case 17 is the same as or slightly larger than the diameter of the inner circumference of the tubular portion 27 of the first case 7 (for example, 0.01 mm or more and 1 mm or less, 0.01 mm or more and 0.5 mm or less, 0.05 mm or more and 0.3 mm or less) Small. With such a size, the second case 17 fits in the first case 7, and in a state where the first element 9 and the second element 19 are combined, the first fixed tube 5 and the second case 17 are combined. The second fixed tube 15 connects the end of the first medical tube 3 and the end of the second medical tube 13 in the direction in which the end of the first medical tube 3 and the end of the second medical tube 13 are joined. By pushing the tube 13, the first medical tube 3 and the second medical tube 13 are connected.

A preferred example of the connection device described above is the inner circumference of the first case 7 and the second case 17, and the first fixed tube 5 and the first when the first element 9 and the second element 19 are combined. It further has a medical tube stabilizing tube 24 located between the outer circumferences of the fixed tube 15 of 2. It is preferable that the inner diameter of the medical tube stabilizing tube 24 is larger than the outer diameter of the first fixed tube 5 and the second fixed tube 15 and smaller than the inner diameter of the second case 17. The length of the medical tube stabilizing tube 24 is preferably longer than the length of each of the first fixed tube 5 and the second fixed tube 15, and the first fixed tube 5 and the second fixed tube 15 are combined. It is preferably equal to or slightly smaller than the length (for example, 0.1 mm or more and 5 mm or less, 0.5 mm or more and 3 mm or less, 1 mm or more and 2 mm or less). The medical tube stabilizing tube 24 prevents the folded medical tubes 3 and 13 from being displaced in the apparatus. That is, the medical tube stabilizing tube 24 is used to stabilize the folded medical tubes 3 and 13. Therefore, the inner diameter of the medical tube stabilizing tube 24 is slightly larger than the outer diameter of the first fixed tube 5 and the second fixed tube 15 by the thickness or the thickness of the medical tube (for example, 0.01 mm or more and 1 mm). Hereinafter, it is preferable that the size is increased by 0.01 mm or more and 0.5 mm or less, 0.05 mm or more and 0.3 mm or less).

The second element 19 includes a second fixed tube 15 that holds the end of the second medical tube 13 in a folded state, and a second case 17 that houses the second fixed tube 5. The second fixed tube 15 is the same as the first fixed tube 5. The open end of the second fixed tube 15 is in contact with the medical tube. The fixed end of the second fixing tube 15 is fixed to the inner circumference of the second case 17.

In the state where the first element 9 and the second element 19 are combined, the first case 1 and the second case 17 approach each other with the first fixed tube 5 and the second fixed tube 15, respectively. To be urged to. As a result, the direction in which the first fixed tube 5 and the second fixed tube 15 join the end of the first medical tube 3 and the end of the second medical tube 13 (inward direction). ), The first medical tube 3 and the second medical tube 13 are bonded.

This connecting device preferably has a snap-fit structure. That is, when the two elements (parts) are put together, the button attached to one fits into the remaining hole, thereby fixing the two elements. Then, the fixed pipes inside each apply a force to the inside. Then, when the button is pressed, the two elements are released. Specifically, the second case 17 is a second cylindrical portion 21 and a protrusion 23 protruding outward from the second tubular portion in normal times, and by applying a force from the outside. It has a protrusion that moves inward from the second tubular portion. On the other hand, the first case 7 accommodates a part of the second tubular portion 21, and in a state where the first element 9 and the second element 19 are combined, the hole portion 25 accommodating the protrusion 23. It has a first cylindrical portion 27 having the above. Therefore, with the protrusion 23 of the second case 17 pushed down, the second case 17 is inserted into the inside of the first case 7, and the second case 17 is slid to slide the protrusion 23. It can be fitted into the hole 25 of the first case 7.

In this connecting device, at least a part of the portion where the first medical tube 3 and the second medical tube 13 come into contact with each other in a state where the first element 9 and the second element 19 are combined is ion-implanted. It may be modified. In this case, the present invention may provide a medical device including the connection device described above and two medical tubes. For example, when a medical tube is manufactured of ePTFE (stretched polytetrafluoroethylene), the ePTFE moiety becomes adhesive by being modified by ionic impact (for example, Japanese Patent No. 4445697, Japanese Patent No. 5505752). issue). Therefore, by modifying the contacting portion of the medical tube, the medical tube can be connected more firmly.

In the above description, the first fixed tube 5 and the first case 7 are separate parts, and the second fixed tube 15 and the second case 17 are different parts. However, the first fixed tube 5 and the first case 7 are integrated (the first fixed tube 5 is fixed to the first case 7), and the second fixed tube 15 and the first case 7 are fixed. The case 17 of 2 may be integrated (the second fixed tube 15 is fixed to the second case 17).

An example of how to use the medical tube connection device is as follows. This step includes a step of preparing the first element 9, a step of preparing the second element 19, and a step of joining the first element 9 and the second element 19. The order of the step of preparing the first element 9 and the step of preparing the second element 19 may come first. The first element 9 has a first fixed tube 5 and a first case 7 accommodating the first fixed tube 5. The second element 19 has a second fixed tube 15 and a second case 17 that houses the second fixed tube 15.

The process of preparing the first element 9 is
The step (S101) of passing the first medical tube 3 through the first case 7 and
A step of inserting the first medical tube 3 into the first fixed tube 5 through the inside of the first fixed tube 5 so that the end portion of the first medical tube 3 protrudes (S102).
The present invention includes a step (S103) of folding back the end portion of the first medical tube 3 protruding from the first fixed tube 5 in the outer peripheral direction of the first fixed tube 5. In addition, S means a step (process).

Step of passing the first medical tube 3 through the first case 7 (S101)
The process of passing the first medical tube 3 through the first case 7 will be described. There is a hole in the ring-shaped wall (left side portion of FIG. 2) of the first case 7. The first medical tube 3 is passed through the hole and guided beyond the end portion (right side in FIG. 2) of the first case 7.

A step of inserting the first medical tube 3 into the first fixed tube 5 through the inside of the first fixed tube 5 so that the end portion of the first medical tube 3 protrudes (S102).
In this step, the first medical tube 3 that has passed through the first case 7 in S101 is inserted into the first fixed tube 5. That is, the first medical tube 3 is guided beyond the end of the first fixed tube 5 in a state where the first medical tube 3 is inside the first fixed tube 5. Then, the end portion of the first medical tube 3 protrudes from the end portion of the first fixed tube 5.

A step of folding back the end of the first medical tube protruding from the first fixed tube 5 in the outer peripheral direction of the first fixed tube 5 (S103).
In this step, the end portion of the first medical tube protruding from the first fixed tube 5 in S102 is folded back in the outer peripheral direction of the first fixed tube 5. In this case, the portion protruding from the inner circumference of the first fixed pipe 5 passes through the end portion of the first fixed pipe 5 and is folded back along the outer circumference of the first fixed pipe 5. This step may be performed, for example, using the folding device described above, or may be performed manually.

The process of preparing the second element 19 is
The step (S201) of passing the second medical tube 13 through the second case 17 and
A step of inserting the second medical tube 13 into the second fixed tube 15 through the inside of the second fixed tube 15 so that the end portion of the second medical tube 13 protrudes (S202).
It has a step (S203) of folding back the end portion of the second medical tube 13 protruding from the second fixed tube 15 in the outer peripheral direction of the second fixed tube 15. These steps are the same as those of S101 to S103.

Next, the medical tube stabilizing tube 24 is located between the inner circumference of the first case 7 and the second case 17 and the outer circumference of the first fixed tube 5 and the second fixed tube 15. , The first fixed tube 5 and the second fixed tube 15 may be inserted into the medical tube stabilizing tube 24 (S301).
In this case, the medical tube folded back in S103 and S203 is between the inner circumference of the first case 7 and the second case 17 and the outer circumference of the first fixed tube 5 and the second fixed tube 15. Will be located. As a result, the fluctuation of the portion of the medical tube folded back in S103 and S203 is hindered, and the medical tube becomes stable.

The step of connecting the first element 9 and the second element 19 is
The first element 9 and the second element 19 are coupled, and the first fixed tube 5 and the second fixed tube 15 are the ends of the first medical tube 3 and the second medical tube 13. A step of pushing the first medical tube 3 and the second medical tube 13 in the direction of joining the end portion, and joining the first medical tube 3 and the second medical tube 13 (a step of joining the first medical tube 3 and the second medical tube 13. It has S401).

At this time, the end portion of the second tubular portion 21 is inserted into the inside of the first tubular portion 27. The protrusion 23 of the second case 17 is provided with a taper. When the second tubular portion 21 is inserted into the first tubular portion 27, the protrusion 23 is pushed down by the first tubular portion 27. On the other hand, when the second tubular portion 21 is further inserted into the first tubular portion 27, the protrusion 23 reaches the hole 25, and the protrusion returns to the normal state. Then, the protrusion 23 acts as a stopper in the hole 25. In this way, the first element 9 and the second element 19 are combined.
For example, the first case 7 and the second case 17 are made of an elastic material such as resin. Then, when the first element 9 and the second element 19 are combined, the first fixed tube 5 and the second fixed tube 15 approach each other by the first case 7 and the second case 17. Being urged in the direction, as a result, pushing the first medical tube 3 and the second medical tube 13 in the direction in which their ends join, thereby causing the first medical tube 3 and the second medical tube 3 and the second. It will be bonded to the medical tube 13.

FIG. 5 is a conceptual diagram for explaining a medical tube connecting device different from that of FIG. FIG. 5 is a partial extraction of a cross section of a medical tube. The medical tube connecting device shown in FIG. 5 (a) has a ring-shaped elastic member between the fixed tube and the flat ring-shaped wall of the case. In the example shown in FIG. 5A, a ring-shaped first elastic member 41 is provided between the first fixed tube 5 and the flat ring-shaped wall portion of the first case 7, and the second case 7. A ring-shaped second elastic member 43 is provided between the fixed tube 15 and the flat ring-shaped wall portion of the second case 17. In this example, the elastic member strongly urges the first fixed tube 5 and the second fixed tube 15, and as a result, the first fixed tube 5 and the second fixed tube 15 are the first medical tubes. The pushing force in the direction of connecting the end of the third and the end of the second medical tube 13 is increased, and the first medical tube 3 and the second medical tube 13 are combined. Examples of elastic members are leaf springs, O-rings, and rubber. In the example shown in FIG. 5B, it has an elastic member integrated with a fixed tube. The first fixed tube 5 has a first elastic member 41 integrated with the first fixed tube 5, and the second fixed tube 15 has a second elastic body integrated with the second fixed tube 15. It has a member 43. In this example, since the fixed tube and the spring are manufactured seamlessly, the number of parts does not increase, and the medical tube does not have unnecessary unevenness.

FIG. 6 is a conceptual diagram for explaining a medical tube connecting device different from that of FIG. In this example, the folded medical tube along the outer circumference of the fixed tube is stabilized by, for example, the inner circumference of the second case 17, so that the medical tube stabilizing tube 24 is not required. be.

The medical tube connecting device of the present invention can be used, for example, as a device for connecting artificial blood vessels of an artificial dialysis machine. Further, the medical tube connecting device of the present invention can also be used as a medical device for connecting an artificial organ and a medical device such as an artificial pancreas or an artificial kidney. In this case, the medical tube connecting device of the present invention may be an implant type (implantable type) medical tube connecting device. This device can be located near the surface of the body rather than near an organ, and it is relatively easy to connect a medical tube and reconnect it to a new medical tube.

Regarding the vascular connection mechanism invented this time, we quantitatively verified the internal pressure and leakage of the connection part, and verified the formation of thrombus in the vascular connection mechanism.
For the verification of this connector, Gore-Tex ePTFE graft (thin wall with removable ring) (W. L. Gore & Associates, Inc.) was used as a material. The inner diameter is 6 mm. The ePTFE graft has a fibrous structure that maintains an air layer inside the fibers to maintain internal pressure resistance (up to 290 mmHg) and prevent plasma leakage. The water pressure resistance of this medical tube is 290 mmHg. If more internal water pressure is applied, the air layer will break and the liquid will seep out of the medical tube.

Internal pressure and leakage of the connect part Since the normal human blood pressure is 120 mmHg at the top and 80 mmHg at the bottom, it is considered that the function as a connector can be maintained if it can withstand a water pressure resistance of 200 mmHg. Therefore, it was confirmed whether or not there was leakage from the connector due to water pressure up to 130 to 200 mmHg, which is a range that does not affect the performance of the medical tube. Figure 7 shows a graph of flow rate and water pressure. The vertical axis shows water pressure and the horizontal axis shows flow rate.

No leakage was confirmed at a water pressure of 130 to 200 mmHg. After that, leakage from the medical tube itself was confirmed at 290 mmHg, but no liquid leakage from the connector itself was confirmed between 290 mmHg. Therefore, it is considered that it has a sufficient function as a connector used in the human body.

Evaluation of thrombosis The coagulation component inside the medical tube is qualitative by surface observation with a scanning electron microscope (SEM) based on the item of "Blood compatibility test" of JIS T 0993 "Biological evaluation of medical equipment". Evaluation was performed. FIGS. 8 to 10 show SEM images of the connector connection portion when human whole blood (Kojin Bio) has flowed into the medical tube to which the connector is connected for 1,24,48 hours. The part surrounded by the frame is a part of the coagulation component. It can be confirmed that the coagulation component is accumulated in the connection portion as the blood flows in for a long time. In addition, as shown in FIG. 11, when blood was flowed in for 48 hours, many blood coagulation components were confirmed in places other than the joints. In the medical tube used this time, Gore-Tex ePTFE graft, a thrombus membrane is initially formed, vascular endothelial cells are fixed on it, and a biological membrane is formed in the medical tube so that it can be used stably for a long period of time. It has become. From this, it can be said that the adhesion of the blood coagulation component, which is a precursor of thrombus membrane formation, to the inner surface of the medical tube is an effective sign for long-term use. In addition, if the current blood coagulation component adheres and a biological membrane can be formed to fill the connector seam when the blood inflow time is further increased, this connector can also be used for long-term blood inflow. It is believed that it can function (the circles indicate where the deposits are prominent).

The present invention can be used in the medical device industry.

3 1st medical tube 5 1st fixed tube 7 1st case 9 1st element 13 2nd medical tube 15 2nd fixed tube 17 2nd case 19 2nd element 21 2nd Cylindrical part 23 Protrusion part 25 Hole part 27 First tubular part

Claims (4)

A first fixed tube (5) that holds the end of the first medical tube (3) in the folded state, and
The first case (7) accommodating the first fixed tube (5) and
The folded portion of the first medical tube (3) is the inner circumference of the first case (7) and the outer circumference of the first fixed tube (5). What will be located between and
A second fixed tube (15) that holds the end of the second medical tube (13) in the folded state, and
A second case (17) accommodating the second fixed tube (15) and
The folded portion of the second medical tube (13) is the inner circumference of the second case (17) and the outer circumference of the second fixed tube (15). What will be located between and
Including
In the state where the first element (9) and the second element (19) are combined, the first fixed tube (5) and the second fixed tube (15) are the first medical tube (3). By pushing the first medical tube (3) and the second medical tube (13) in the direction in which the end of the first medical tube (13) and the end of the second medical tube (13) are joined, the first medical tube is used. The tube (3) and the second medical tube (13) are bonded,
Medical tube connection device. The connection device according to claim 1.
The first medical tube (3) and the second medical tube (13) are artificial blood vessels, which are connecting devices. The connection device according to claim 2.
When the first element (9) and the second element (19) are in a combined state,
A medical tube stabilizing tube located between the inner circumference of the first case (7) and the second case (17) and the outer circumference of the first fixed tube (5) and the second fixed tube (15). 24) further,
Connection device. The connection device according to claim 3.
At least a part of the portion where the first medical tube (3) and the second medical tube (13) come into contact with each other in a state where the first element (9) and the second element (19) are combined is. A connecting device that has been modified by ionic impact.

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