JP2021122447A - Medical member and manufacturing method of the same - Google Patents

Abstract

To provide a joint part structure which can achieve the sufficient joint strength and secure the stability and safety while preventing the deterioration of a raw material and the shortage and reduction in the joint strength due to heating in a medical member including the joint part structure that connects other members to various tubular materials.SOLUTION: The medical member includes such a structure that a tubular material 3 is connected to a connection body 4 that is connected to an opening end part 3c provided on one side in the axial direction of the tubular material. The connection body comprises: a tube end contact part 4a which is in a state of being in contact with the opening end part on the one side; an in-tube arrangement part 2 which is fixed to the tube end contact part and has an annular groove 2c at a position facing the inner peripheral surface thereof; and a cylindrical tube outer covering part 4b which is in contact with the tube end contact part and attached on the outer periphery of the tubular material. With the plastic deformation of an end edge 4c on the other side of the tube outer covering part over the whole periphery to the obliquely inner side toward the one side, the end edge on the other side is annularly engaged with an outer peripheral surface 3a of the tubular material and a portion 3e of an inner peripheral surface 3d of the tubular material is engaged with the inside of the annular groove 2c.SELECTED DRAWING: Figure 6

Description

The present invention relates to a medical member and a method for manufacturing the same.

Conventionally, a medical catheter that is a tubular medical member that is inserted into the body cavity or bladder, urinary tract, trachea, esophagus, stomach, large intestine, etc. to discharge liquids such as body fluids and contents, or to inject drug solutions and contrast media. Medical members having a tubular structure at least in part, such as a puncture needle and a puncture needle, are widely used. This type of medical member includes those used for therapeutic medical devices (such as surgical catheters) and those used for diagnostic medical devices (such as endoscopes). Further, as the medical member, not only the one incorporated in the medical device but also the one used alone.

The above medical member may have a joint structure for connecting another member to the resin tube, but since at least a part of the medical member is introduced into the patient's body, the overall stability and joint including the joint structure and joint are provided. It is necessary to secure the joint strength of the part structure, and it is also necessary to make the external dimensions as compact as possible. As a medical member having such a joint structure (such as a medical catheter and a puncture needle used for an endoscope), those described in Patent Document 1 below are known.

Japanese Unexamined Patent Publication No. 2008-188304

By the way, in the medical catheter described in Patent Document 1, the distal end side tube 30A and the hand side tube 30B are joined at a joining portion 31, and the joining method includes a heat fusion method and various bonding methods. Adhesion methods using agents have been adopted (see paragraphs 0153 to 0157). However, when the heat fusion method is adopted, there is a risk that the material may be altered by heating, which may reduce the durability of the bonding strength and cause the material to separate during use. Further, even when the bonding method is adopted, it is often the case that sufficient bonding strength cannot be secured depending on the combination of resin materials, and the bonding strength may be further lowered by bonding the resin and the metal.

The present invention solves the above problems, and the problem is to prevent deterioration of the material and insufficient or decrease of joint strength due to heating in a medical member having a joint structure for connecting other members to various tubular materials. At the same time, it is an object of the present invention to provide a medical member having a joint structure capable of achieving sufficient joint strength and ensuring stability and safety.

In order to solve the above problems, the medical member according to the present invention is a medical member having a structure in which a tubular material and a connecting body connected to an opening end on one side in the axial direction of the tubular material are joined. Therefore, the connecting body is integrated with the pipe end contact portion which is in a state of being in contact with the opening end portion on one side of the tubular material in the axial direction and the pipe end contact portion. With respect to the in-pipe arrangement portion which is configured or fixed in the above and is housed and arranged inside the tubular material and has an annular groove at a position facing the inner peripheral surface of the tubular material, and the pipe end contact portion. It has a tubular outer covering portion that is integrally formed, fixed, or abuts at least toward the one side in the axial direction, and is mounted on the outer periphery of the tubular material. The other end edge of the outer tube covering portion opposite to the one side is plastically deformed diagonally inward toward the one side over the entire circumference, so that the other end edge becomes the outer peripheral surface of the tubular material. On the other hand, it is characterized in that a part of the inner peripheral surface of the tubular material is inserted into the inside of the annular groove as well as being inserted into the annular shape. Here, the tubular material is preferably made of a flexible material including a resin material.

Next, in the method for manufacturing a medical member according to the present invention, there is a method for manufacturing a medical member having a structure in which a tubular material and a connecting body connected to an opening end on one side in the axial direction of the tubular material are joined. The connecting body is in contact with the opening end portion on one side of the tubular material in the axial direction, and the pipe end contact portion with respect to the pipe end contact portion. In the pipe arrangement portion which is integrally formed or fixed, and which is housed and arranged inside the tubular material and has an annular groove at a position facing the inner peripheral surface of the tubular material, and the pipe end contact portion. On the other hand, it has a tubular outer covering portion that is integrally formed, fixed, or abuts at least toward the one side in the axial direction and is mounted on the outer periphery of the tubular material. , Pressurizing by a conical surface inclined with respect to the axial direction, plastically deforming the edge of the outer covering portion on the other side opposite to the one side diagonally inward to the one side over the entire circumference. Therefore, the other end edge is annularly inserted into the outer peripheral surface of the tubular material, and a part of the inner peripheral surface of the tubular material is configured to enter the inside of the annular groove. .. Here, the tubular material is preferably made of a flexible material including a resin material.

According to each of the above inventions, the other end edge of the outer covering portion of the tube covering the outer periphery of the tubular material is plastically deformed obliquely inward over the entire circumference so as to be recessed into the outer peripheral surface of the tubular material. At the same time, a part of the inner peripheral surface of the tubular material is made to enter the inside of the annular groove, so that a joint structure with high airtightness, high joint strength, and high stability can be obtained without using heating or adhesion. Can be configured. Therefore, it is possible to avoid problems due to heating and adhesion, and to manufacture a medical member having higher stability and safety than the conventional joint structure.

In the present invention, the base end portion on the other side arranged inside the tubular material corresponds to the arrangement portion in the pipe, and is led out from the inside of the opening end portion on the one side of the tubular material to the one side. It is preferable to have an extending needle tube. At this time, a fitting groove is formed on the outer peripheral surface of the needle tube at a position facing the inner peripheral surface of the tube end contact portion on one side of the annular groove, and the one of the tube end contact portions is formed. It is preferable that a part of the inner peripheral surface of the pipe end contact portion has entered the inside of the fitting groove due to the plastic deformation in which the concave portion is formed on the side end surface. According to this, even if the pipe end contact portion and the pipe interior arrangement portion are separate bodies, both can be fixed without using heating or adhesion, so that the joint strength of the joint structure can be ensured and as a medical member. There is an advantage that it does not easily affect the characteristics of.

In the present invention, it is preferable that the pipe end contact portion and the pipe end arrangement portion are configured by an integral closing member that is attached to the opening end portion on one side of the tubular material to close the opening. At this time, it is desirable that the pipe end contact portion and the pipe outer coating portion are separate bodies.

In the present invention, the pipe end contact portion and the pipe outer coating portion may be integrally formed. Further, the pipe end contact portion and the pipe outer coating portion may be configured as separate bodies. When the pipe end contact portion and the pipe outer coating portion are formed as separate bodies, a step structure open toward the other side is provided on the outer peripheral portion of the pipe end contact portion, and the pipe end contact portion is provided with a step structure that opens toward the other side. It is desirable that the one-sided end of the covering is engaged in a state of being arranged on the support surface under the step of the step structure, and the one-side end is in contact with the step of the step structure. According to this, in a state where one end of the outer covering portion of the pipe is arranged on the support surface under the step of the step structure of the pipe end contact portion, the end of the one side is of the step structure. By contacting the step, even if the pipe end contact portion and the pipe outer coating portion are separated, the engaged state of both can be stabilized, so that the joining process of the tubular material and the connecting body can be easily performed. At the same time, it becomes easy to form a reliable joint structure.

In the present invention, the inclination angle of the conical surface with respect to the axial direction is preferably in the range of 3 to 30 degrees. In particular, the inclination angle is preferably in the range of 5 to 15 degrees. By making the inclination angle smaller than 45 degrees, the edge on the other side can be plastically deformed at an angle in which the pressurizing direction by the pressurizing member is closer to the axial direction than the radial direction. Since the other end edge can be deformed toward the tubular material on the inner peripheral side without giving an excessive axial compression action to the tubular material, the axial tension between the tubular material and the connecting body can be obtained. The strength can be increased.

In the present invention, in the region where the in-pipe arrangement portion of the tubular material is internally arranged, the external dimension of the tubular material is deformed to the outer peripheral side by the internal pressure of the in-pipe arrangement portion and is larger than other regions. It is desirable to be configured. According to this, since the external dimension of the tubular material is made larger than other regions by the in-pipe arrangement portion, the adhesion between the tubular material and the in-pipe arrangement portion can be improved, so that the joint strength of the joint structure can be improved. Can be further improved.

In the present invention, the axial position of the edge of the outer covering portion of the tube with respect to the outer peripheral surface of the tubular material is within the axially formed region of the annular groove provided in the in-pipe arrangement portion. It is preferably included and separated from any of the positions of both side edges of the annular groove in the axial direction. In this way, when the other end edge of the outer tube covering portion is plastically deformed to the oblique inner peripheral side, a part of the inner peripheral surface of the tubular material easily enters the inside of the annular groove. .. Further, at a position in the axial direction of the other end edge, which is located at a position separated from any side edge on both sides of the annular groove in the axial direction, the tubular material enters a part of the annular groove on the inner peripheral surface. Since the amount is maximized, the engagement between the inner peripheral surface of the tubular material and the annular groove is preferred, and in particular, the axial tensile strength in the joint structure is improved.

In the present invention, with respect to the side edge shapes of the annular groove on both sides in the axial direction, the inclination of the one side edge with respect to the axial direction is relatively small, and the inclination of the other side edge with respect to the axial direction is relative. It is preferable that the size is large. In particular, it is desirable that the inclination of the side edge on one side is close to horizontal and the inclination of the side edge on the other side is close to vertical. According to this, by reducing the inclination of the side edge on one side, a part of the inner peripheral surface of the tubular material can easily enter the annular groove, and the inclination of the side edge on the other side is large, so that the annular material It is possible to increase the axial tensile strength of the tubular material and the connecting body when a part of the inner peripheral surface of the tubular member enters the annular groove.

According to the present invention, in a medical member provided with a joint structure for connecting a connecting body to a tubular material, sufficient joint strength is realized and stability is realized while preventing deterioration of the material and insufficient or decrease of joint strength due to heating. It is possible to provide a medical member having a joint structure that can ensure safety and safety.

It is the schematic which shows the whole structure of the 1st Example of the medical member which concerns on this invention. FIG. 5 is an enlarged partial cross-sectional view showing the structure of the joint portion J of the medical member of the first embodiment after the first step in an enlarged manner. FIG. 5 is an enlarged partial cross-sectional view showing the structure of the joint portion J of the medical member of the first embodiment after the second step in an enlarged manner. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a first embodiment before the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a first embodiment in the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of the medical member of the first embodiment after the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a second embodiment after the first step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a second embodiment after the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a third embodiment after the first step (second step). FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a third embodiment before the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a third embodiment in the third step. FIG. 5 is an enlarged partial cross-sectional view showing an enlarged structure of a joint portion J of a medical member according to a third embodiment after the third step.

Next, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. First, with reference to FIG. 1, the overall configuration of an example of the medical member of the first embodiment according to the present invention, more specifically, various medical members constituting the puncture needle and the catheter will be described. This embodiment is, for example, an ultrasonic endoscope or other endoscope, or a medical member 1 which is a joint body (puncture member) of a needle tube and a flexible tube used for a puncture needle used for various catheters and the like. Is shown as an example of. In the medical member 1, the needle tube 2 and the flexible tube 3 to which the needle tube 2 is connected are joined at a joint portion J. The joint portion J includes a joint portion structure in which the base end portion of the needle tube 2 and the tip end portion of the flexible tube 3 are joined by using the joint block 4.

The needle tube 2 is made of a metal such as stainless steel and has an open tip that is inserted into the body for collecting tissue (cells) or injecting a drug or the like, and the tip is sharply configured. .. The base end portion 2b of the needle tube 2 is also opened and inserted into the tip end portion 3b of the flexible tube 3. Considering the use as a puncture needle, the outer diameter of the needle tube 2 is preferably in the range of 0.3 to 1.2 mm, and particularly preferably in the range of 0.4 to 0.8 mm. The length of the needle tube 2 is preferably in the range of 6.0 to 20.0 mm, and particularly preferably in the range of 8.0 to 16.0 mm. An annular groove 2c is formed on the outer peripheral surface 2a of the needle tube 2 in the region of the base end portion 2b inserted inside the flexible tube 3. Here, the annular groove 2c is arranged at a position on the outer peripheral surface 2a facing the inner peripheral surface 3d of the flexible tube 3. Further, a position (a position deviated from the base end portion 2b to one side) protruding from the inside of the flexible tube 3 on the outer peripheral surface 2a to one side (left side in the drawing) in the axial direction, and the pipe end contact portion 4a A fitting groove 2d is formed at a position facing the inner peripheral surface 4d of the above. In the present embodiment, the base end portion 2b of the needle tube 2 corresponds to the in-tube arrangement portion housed and arranged inside the flexible tube 3. Further, the flexible tube 3 corresponds to a tubular material.

The flexible tube 3 corresponds to the above-mentioned tubular material, and in the present embodiment, it is made of a synthetic resin such as fluororesin (PFA) or polyethylene (PE). The outer diameter of the flexible tube 3 is preferably in the range of 0.5 to 2.0 mm, and more preferably in the range of 0.8 to 1.5 mm. The length of the flexible tube 3 varies depending on the structure of the puncture needle and the catheter, but may exceed 1000 mm. The flexible tube 3 has flexibility that can be curved along the axial direction, but preferably has elasticity that can be deformed in the radial direction as well. For example, when the outer diameter of the base end portion 2b of the needle tube 2 is slightly larger than the inner diameter of the flexible tube 3, the outer diameter of the tip end portion 3b of the flexible tube 3 into which the base end portion 2b of the needle tube 2 is inserted is inserted. However, the outer diameter of the region on the other side (right side in the drawing) of the flexible tube 3 into which the needle tube 2 is not inserted is slightly increased (for example, within the range of 1.0 to 10.0%). It is desirable to be configured in. That is, it is preferable that the in-tube arrangement portion (base end portion 2b) is in close contact with the inner peripheral surface 3d of the tubular material (flexible tube 3), and in particular, some force (elasticity of the flexible tube 3 in the illustrated example). It is desirable that it is in a state of being pressed by force).

At the joint portion J, the needle tube 2 and the flexible tube 3 are joined by the joint block 4. The joining block 4 has an annular pipe end contact portion 4a provided with a contact surface 4p that contacts the open end portion 3c of the tip portion 3b of the flexible tube 3, and the pipe end contact portion 4a. A tubular shape that is arranged on the other side of the axial direction in the direction of the axis Jx (hereinafter, simply referred to as "axis direction"), abuts from one side, and covers the tip portion 3b of the flexible tube 3 from the outer peripheral side thereof. It has a tube outer coating portion 4b (cylindrical in the illustrated example). In the illustrated example, the pipe end contact portion 4a and the pipe outer coating portion 4b are integrally formed. However, as in the second embodiment described later, the pipe end contact portion 4a and the pipe outer coating portion 4b may be formed as separate bodies so as to be in contact with each other in the axial direction. When the pipe end contact portion 4a and the pipe outer coating portion 4b are integrally formed, the joining block 4 is preferably made of a metal such as stainless steel. When the pipe end contact portion 4a and the pipe outer coating portion 4b are separately configured, the pipe end contact portion 4a may be made of metal or resin, but the pipe outer coating portion 4b is made of metal. Is preferable.

It is preferable that the corner portion 4h between the outer peripheral side and the end surface 4e on one side of the pipe end contact portion 4a is rounded or chamfered. According to this, by rounding or chamfering the corner portion 4h on one side on the tip side when the medical member 1 is inserted into the body, the shape can be easily introduced into various places as the medical member.

Note that FIG. 2 is an enlarged partial cross-sectional view showing an example in which the first step of the manufacturing process for joining the needle tube 2 and the flexible tube 3 of the medical member 1 is completed. In this first step, the base end portion 2b of the needle tube 2 is inserted into the tip portion 3b of the flexible tube 3, and the joining block 4 is fitted between the base end portion 2b and the tip portion 3b from the outside. be. However, in this state, the needle tube 2 and the flexible tube 3 are not joined, and does not indicate a state in which the structure of the joint portion J is completed. Further, the state shown in FIG. 2 shows, but is not limited to, an example of a state before the first step is completed and the second step described later is started. For example, when the first step is completed, only the joining block 4 (tube end contact portion 4a) is attached to the outer circumference of the base end portion 2b of the needle tube 2, and the tip portion 3b of the flexible tube 3 is arranged. It may be absent. In this case, after the second step is completed and before the third step is carried out, a flexible tube is formed between the base end portion 2b of the needle tube 2 and the outer covering portion 4b of the joining block 4. It is necessary to insert the tip portion 3b of 3.

FIG. 3 is an enlarged partial cross-sectional view showing how the second step of the manufacturing process is completed. In this second step, a pressurizing member (punch) 5 having an annular pressurizing portion 5a around the axis is formed in a state where the needle tube 2 and the tube end contact portion 4a of the joining block 4 are overlapped inside and outside in the radial direction. It acts on the end surface 4e on one side of the joining block 4 from one side in the axial direction. As a result, in the joint block 4, an annular recess 4f is formed in the end surface 4e, and a part 4g of the inner peripheral surface 4d of the joint block 4 flows and enters the inside of the fitting groove 2d. Occurs. As a result, the needle tube 2 and the joining block 4 are firmly fixed. In the illustrated example, the fitting groove 2d, the pressurizing portion 5a, and the recess 4f are all formed in an annular shape around the axis, but the present invention is not limited to such an annular shape, and as a result, the needle tube 2 It is sufficient that the (arranged portion in the pipe) and the joining block 4 (contacting portion 4a at the pipe end) are securely fixed. For example, by forming the fitting groove 2d discontinuously in the circumferential direction, the tube end contact portion 4a and the needle tube 2 can be fixed around the axis.

In the second step, the protruding shape of the pressurizing portion 5a is shown in the illustrated example so that a part 4g of the inner peripheral surface 4d of the pipe end contact portion 4a easily flows into the inner fitting groove 2d. As described above, it is preferable to form the inner side surface in the radial direction so that the inclination angle with respect to the axial direction of the inner side surface in the radial direction is larger than the inclination angle of the outer side surface in the radial direction with respect to the axial direction.

FIG. 4 is an enlarged partial cross-sectional view showing a state before the start of the third step. In the third step, a pressurizing member 6 having an annular pressurizing portion 6a is used. The surface (pressurized surface) of the pressurizing portion 6a is a conical surface 6b having an inclination angle θ with respect to the axial direction. The inclination angle θ is preferably in the range of 1 to 45 degrees, and particularly preferably in the range of 3 to 30 degrees. In particular, it is more desirable to be in the range of 5 to 15 degrees. In the present embodiment, the inclination angle θ is set in the range of 8 to 12 degrees, for example, 10 degrees. If the inclination angle θ is less than 45 degrees, the pressing force applied from the pressurizing portion 6a is distributed more inward in the radial direction than in the axial direction, so that the joining block 4 is not excessively subjected to the pinching pressure in the axial direction. Appropriate deformation can be generated in the radial direction. In this third step, the pressurizing member 6 is moved toward one side in the axial direction, and as shown in FIG. 5, the pressurizing portion 6a completely covers the other end edge 4c of the pipe outer covering portion 4b. Deform diagonally inward over the circumference.

As described above, as shown by the dotted line in FIG. 5, when the edge 4c is deformed diagonally inward over the entire circumference by the pressing force applied from the pressurizing portion 6b, the inner corner portion 4i of the edge 4c becomes a flexible tube. The flexible tube 3 is locally deformed in an annular shape inward in the radial direction over the entire circumference by being inserted into the outer peripheral surface 3a of 3, and a part 3e of the inner peripheral surface 3d inside the deformed region is deformed over the entire circumference. It enters the inside of the annular groove 2c. In this way, the structure of the joint J is completed. In this third step, the edge 4c of the outer covering portion 4b is plastically deformed diagonally inward by the pressure portion 6a, but the amount of deformation inward in the radial direction is the thickness (tubular) of the outer covering portion 4b. It can be increased or decreased according to the increase or decrease of the step amount of the edge 4c on the outer peripheral surface 3a of the flexible tube 3 which is a material. Further, the amount of deformation and the range of deformation in the axial direction can be increased or decreased according to an increase or decrease in the amount of movement of the pressurizing portion 6a toward one side in the axial direction.

At this time, the edge 4c, more preferably the axial position Pi of the inner corner portion 4i, is arranged inside the axially formed region 2e of the annular groove 2c of the needle tube 2. Further, inside the formation region 2e, the axial position Pi of the edge 4c or the inner corner portion 4i is separated from any of the axial side edges 2c1 and 2c2 of the annular groove 2c, and these There is an interval for any of the positions of. In this way, by biting into the outer peripheral surface 3a of the inner corner portion 4i, which will be described later, it becomes easier for a part 3e of the inner peripheral surface 3d of the flexible tube 3 to enter the inside of the annular groove 2c. The 3e easily enters the inside of the annular groove 2c. Further, the degree of engagement between the part 3e and the annular groove 2c in the axial direction can be increased, and the tensile strength of the joint portion J can be improved.

In the illustrated example, as shown in FIGS. 3 and 6, the cross-sectional shape of the annular groove 2c is rectangular, and the side edges on both sides in the axial direction are surfaces along the radial direction and are perpendicular to the axial direction. It has become. Such a cross-sectional shape of the annular groove 2c is useful for increasing the joint strength in the axial direction of the joint portion J. Further, the cross-sectional shape of such a groove has an advantage that it can be easily processed.

However, the degree of engagement of the flexible tube 3 with the inner peripheral surface 3d is further increased, and a part 3e of the inner peripheral surface 3d is strongly engaged with the annular groove 2c in the axial direction to increase the tensile strength of the joint portion J. In order to do so, as shown in an enlarged view on the upper right of FIG. 3, the inclination of the side edge 2c1 of the annular groove 2c on one side in the axial direction is loosened, and the angle between the side edge 2c1 and the axial direction is set. It is preferable that the angle between the side edge 2c2 and the axial direction is increased by making the inclination of the side edge 2c2 of the annular groove 2c on the other side in the axial direction steep. This is because the gentle inclination of the side edge 2c1 makes it easier for the part 3e to enter the inside of the annular groove 2c, and the steep inclination of the side edge 2c2 reduces the degree of engagement between the part 3e and the annular groove 2c. This is because the strength of the flexible tube 3 to prevent the flexible tube 3 from coming off to the other side in the axial direction with respect to the needle tube 2 and the joining block 4 is increased.

Each component of the base end portion (internal arrangement portion) 2b of the needle tube 2, its annular groove 2c, the flexible tube 3, and the end edge 4c of the outer tube covering portion 4b is centered on the axis Jx as shown in the illustrated example. Most preferably, it is configured to have a concentric shape (perfect annulus, cylinder or conical surface). However, if each of the above-mentioned constituent parts exists over the entire circumference around the axis Jx and is configured to have a closed shape, the airtightness (airtightness) around the axis Jx can be ensured, and the airtightness around the axis Jx can be ensured. Tensile strength is also increased. However, if there are discontinuous steps or creases around the axis Jx, the airtightness and tensile strength will also decrease. Therefore, the joint structure of each component does not have to be a shape that follows a perfect circle around the axis. It may be a circular shape having a continuous curved contour without discontinuities or inflection points such as an ellipse or an oval, that is, a cylindrical shape or a conical shape.

According to this embodiment, it is possible to realize the structure of the joint portion J having good adhesion between the needle tube 2 and the flexible tube 3, high joint strength, and high stability without heating or bonding. In particular, the edge 4c on the other side of the outer covering portion 4b, which is opposite to the one side, is plastically deformed obliquely inward toward the one side in an annular shape over the entire circumference, so that the edge 4c on the other side is tubular. A part 3e of the inner peripheral surface 3d of the flexible tube 3 which is a material is inserted into the inside of the annular groove 2c. As a result, it is possible to avoid a shortage or decrease in airtightness that causes liquid leakage between the needle tube 2 and the flexible tube 3. Further, when the plastic deformation occurs, the contact surface 4p of the pipe end contact portion 4a of the joint block 4 fixed to the needle tube 2 comes into contact with the open end portion 3c of the flexible tube 3 in the axial direction. Since the flexible tube 3 is supported from one side, the edge 4c on the other side of the outer covering portion 4b can be easily plastically deformed diagonally inward to the one side, and can be processed accurately and reliably. Further, even when a tubular material made of a resin material such as a flexible tube 3 is joined, the tensile strength of the joint portion J in the axial direction can be ensured, and the durability of the joint portion J is also enhanced. be able to.

In the present embodiment, unlike the usual caulking process in which the outer covering portion 4b is narrowed from the outer side to the inner side in the radial direction, the edge 4c on the other side in the axial direction of the outer covering portion 4b is plastically deformed diagonally inward to one side in the axial direction. Therefore, since the edge 4c is deformed instead of the tubular portion of the outer covering portion 4b, there is an advantage that plastic deformation becomes easy, and as a result, it can be deformed evenly over the entire circumference. .. Further, since the caulking direction is not inward in the radial direction but diagonally inward to one side, the resistance to deformation is reduced and the amount of deformation can be easily increased. Therefore, the amount of bite into the flexible tube 3 and the flexible tube Since it becomes easy to secure the amount of penetration into the annular groove 2c of a part 3e of 3, it becomes easy to obtain a reliable joint state. It should be noted that these points are the same in other embodiments described later.

Next, the medical member of the second embodiment according to the present invention will be described with reference to FIGS. 7 and 8. In this second embodiment, the pipe end contact portion 14a and the pipe outer covering portion 14b corresponding to the joint block 4 of the first embodiment are separately configured. However, the needle tube 12 and the flexible tube 13 other than the above can be configured in the same manner as the needle tube 2 and the flexible tube 3 of the first embodiment.

As shown in FIG. 7, the initial pipe end contact portion 14a is in contact with the outer peripheral portion on the other side in the axial direction, that is, the outer peripheral side of the contact surface 14p where the open end portion 13c of the flexible tube 13 abuts. In addition, a stepped structure 14j is formed. The step structure 14j includes a step surface 14jx formed between the outer peripheral portion of the pipe end contact portion 14a and a portion on one side thereof, and a support surface 14jy below the step of the step surface 14jx. .. One end portion 14k of the pipe outer covering portion 14b engages with the stepped structure 14j. The end surface 14kx of the end portion 14k is in contact with the stepped surface 14jx in the axial direction. Further, the end portion 14k is supported in the radial direction by the support surface 14jy. In the illustrated example, the amount of the step in the radial direction of the step structure 14j and the thickness of the outer covering portion 14b of the pipe substantially correspond to each other, but they do not necessarily have to be the same. However, it is preferable that the thickness of the outer covering portion 14b of the pipe is the same as or smaller than the step amount of the step structure 14j. This is because, after the needle tube 12 and the flexible tube 13 are joined, the end edge of the end portion 14k of the tube outer coating portion 14b does not protrude from the outer peripheral surface of the tube end contact portion 14a, so that the end edge of the end portion 14k is reached. This is because it is possible to reduce a problem that the end portion 14k of the pipe outer coating portion 14b is disengaged from the pipe end contact portion 14a due to something hitting the pipe end contact portion 14a and the joint is loosened.

FIG. 8 shows the joint state of the needle tube 12 and the flexible tube 13. Similar to the first embodiment, the pressure portion of the pressure member is applied to the end surface 14e on one side of the pipe end contact portion 14a to form the recess 14f, and the composition of the pipe end contact portion 14a is deformed. The tube end contact portion 14a is fixed to the needle tube 12 by allowing a part 14g of the peripheral surface 14d to enter the inside of the fitting groove 2d. Further, in this state, by performing the same joining operation as in the first embodiment, the other end edge 14c of the outer tube covering portion 14b is plastically deformed diagonally inward to one side over the entire circumference. Due to the composition deformation of the edge 14c, the inner corner portion 14i of the edge 14c bites into the outer peripheral surface 13a of the flexible tube 13 over the entire circumference, and as a result, a part 13e of the inner peripheral surface 13d of the flexible tube 13 Enters the inside of the annular groove 12c of the needle tube 12 over the entire circumference.

In the present embodiment, the pipe end contact portion 14a and the pipe outer coating portion 14b, which are separate from each other, are provided, and these are engaged in the radial direction in a state of being in contact with each other in the axial direction by the step structure 14j. The joining work can be facilitated, for example, the outer covering portion 14b can be attached at an appropriate timing during manufacturing. For example, initially, only the tube end contact portion 14a is attached to the needle tube 2 to perform mutual joining work, and then the tip end portion 13b of the flexible tube 13 is inserted into the base end portion 12b of the needle tube 12. , The outer covering portion 14b of the pipe can also be fitted externally. Further, by separating the pipe end contact portion 14a and the pipe outer coating portion 14b, it becomes possible to form these with different materials from each other. For example, by forming the pipe end contact portion 14a with a resin material and the pipe outer coating portion 14b with a metal material, the pipe end contact portion 14a and the needle tube 12 can be fixed by a method other than plastic flow, for example, an adhesive. It is also possible to carry out by the bonding method such as. This means that the optimum fixing method can be adopted according to the relationship between the materials of the tube end contact portion 14a and the needle tube 12 (internal arrangement portion), and as a result, the selectivity for the configuration to be joined to each other can be adopted. And it becomes possible to expand the adaptability.

Also in this embodiment, the corner portion 14h on the outer peripheral side on one side in the axial direction of the pipe end contact portion 14a can be smoothly inserted into the body or the like by rounding or chamfering. Further, also in this embodiment, it is also effective to form the cross-sectional shape of the annular groove 2c as shown in the upper right of FIG. 3 as in the first embodiment. Further, in this embodiment, similarly to the first embodiment, the same effect can be obtained by setting the inclination angle θ of the conical surface 6b of the pressurizing portion 6a with respect to the axial direction in the above range.

Next, the medical member of the third embodiment according to the present invention will be described with reference to FIGS. 9 to 12. In this third embodiment, as shown in FIG. 9, by attaching the closing member 24 to the open end 23c of the tip 23b of the flexible tube 23, the tip of the flexible tube 23 on one side in the axial direction is attached. 23b is closed. The closing member 24 has a pipe end contact portion 24a and an in-pipe arrangement portion 24 m integrally configured (fixed) with respect to the pipe end contact portion 24a. Here, the closing member 24 may integrally include the pipe outer covering portion 24b, but in the illustrated example, the pipe outer covering portion 24b is configured separately from the closing member 24. In the case of the present embodiment, the pipe outer covering portion 24b is in axial contact with the stepped surface of the contact surface 24p between the pipe end contact portion 24a of the closing member 24 and the pipe inner arrangement portion 24m. .. Similar to the step structure 14j of the second embodiment, the one end portion 24k of the tube outer covering portion 24b is engaged separately from the contact surface 24p with which the open end portion 23c of the flexible tube 23 abuts. The step structure 24j (shown dotted line) to be formed may be formed. An annular groove 24n is formed on the outer peripheral surface of the in-pipe arrangement portion 24m.

In this embodiment, since the pipe end contact portion 24a having the contact surface 24p and the pipe inner arrangement portion 24m are integrally formed, the second step for fixing the two to each other is unnecessary. In the first step, the flexible tube 23 and the outer covering portion 24b are inserted into the closing member 24, and then the third step is carried out. In the third step, as shown in FIG. 10, the pressurizing portion 26a of the pressurizing member 26 is used as in the first embodiment. Then, as shown in FIG. 11, the pressurizing member 26 is moved in the axial direction, the conical surface 26b of the pressurizing portion 26a is brought into contact with the other end edge 24c of the pipe outer covering portion 24b, and the end edge 24c is brought into contact with the other end edge 24c. It is plastically deformed diagonally inward to one side over the entire circumference. Finally, the inner corner portion 24i of the edge 24c bites into the outer peripheral surface 23a of the flexible tube 23 over the entire circumference, and as a result, a part 23e of the inner peripheral surface 23d of the flexible tube 23 becomes an annular groove 24n. Enter all around.

In this embodiment, a closing member 24 having a pipe end contact portion 24a and an in-pipe arrangement portion 24m and a pipe outer covering portion 24b are joined to the opening end portion 23c on one side of the flexible tube 23, and the joint portion is joined. It is closed due to the structure of. For this reason, due to the plastic deformation of the end edge 24c of the outer tube covering portion 24b diagonally inward, the inner corner portion 23i bites into the outer peripheral surface 23a of the flexible tube 23 over the entire circumference, and one of the inner peripheral surfaces 23d. Since the portion 23e enters the inside of the annular groove 24n of the in-pipe arrangement portion 24m over the entire circumference, the opening end portion 23c can be closed airtightly.

Also in this embodiment, the corner portion 24h on the outer peripheral side on one side in the axial direction of the pipe end contact portion 24a can be smoothly inserted into the body or the like by rounding or chamfering. Further, as shown in the illustrated example, the inclination angle of the cross-sectional shape of the annular groove 24n on one side in the axial direction with respect to the axial direction is small, and the inclination angle of the other side edge in the axial direction is large. As a result, it is possible to facilitate the entry of a part 23e of the inner peripheral surface 23d of the flexible tube 23 into the annular groove 24n and to increase the engagement strength of the part 23e with the annular groove 24n. The axial tensile strength of the flexible tube 23 with respect to the connecting body (closing member 24 and outer covering portion 24b) can be improved.

Further, also in the present embodiment, as in the first embodiment, by setting the inclination angle θ of the annular surface 6b of the pressurizing portion 6a with respect to the axial direction in the above-mentioned angle range, the edge of the outer covering portion 24b of the pipe is set. The 24c can be appropriately and surely plastically deformed diagonally inward, and a strong structure of the joint J can be realized. It should be noted that each of the above-described embodiments can be appropriately modified by a method such as replacing each component with each other, unless there is a mutual contradiction or a situation that cannot be implemented.

The joint structure and catheter of the medical member of the present invention are not limited to the above-mentioned illustrated examples, and it goes without saying that various modifications can be made without departing from the gist of the present invention. For example, in each of the above embodiments, the flexible tubes 3, 13 and 23 are used as the tubular material, and the joining block 4 or the pipe end contact portion 14a and the connecting member between the pipe outer covering portion 4b and the needle tube 2 are used as the connecting body. Alternatively, the closing member 24 and the outer covering portion 24b are assumed. However, as the tubular material, a metal pipe body can be used, and various configurations can be adopted as long as the connecting body is provided with a pipe end contact portion, a pipe inner arrangement portion, and a pipe outer coating portion. Can be done.

Further, in each of the above embodiments, the thickness of the outer tube covering portions 4b, 14b, 24b is smaller than the thickness of the flexible tubes 3, 13, 23 which are tubular materials, whereby from the outer peripheral surface (3a) of the tubular material. However, in the present invention, the overhang of the connecting body can be reduced, but the material of the outer covering portions 4b, 14b, 24b and the flexible tubes 3, 13, 23 which are tubular materials is not particularly limited. It is set appropriately according to the mechanical characteristics caused by. .. Further, the depth of the annular grooves 2c, 12c, 24n and the width in the axial direction may be set according to the thickness and mechanical characteristics of the flexible tubes 3, 13, 23 which are tubular materials, but in general, they may be set. It is preferable that the flexible tubes 3, 13 and 23 are deeper and wider as the thickness increases, and in this case, it is desirable to increase the thickness of the outer covering portions 4b, 14b and 24b of the forming tube.

1 ... Medical member (catheter), 2 ... Needle tube, 2a ... Outer peripheral surface, 2b ... Base end, 2c ... Circular groove, 2d ... Fitting groove, 2e ... Axial forming region, 3 ... Resin tube, 3a ... Outer circumference Surface, 3b ... Tip, 3c ... Open end, 3d ... Inner peripheral surface, 3e ... Part, 4 ... Joint block, 4a ... Tube end contact, 4b ... Tube outer coating, 4c ... Edge, 4d ... Inner peripheral surface, 4e ... End surface, 4f ... Recessed part, 4g ... Part, 4h ... Corner part, 4i ... Inner corner part, 4j ... Step structure, J ... Joint part, Jx ... Axis line, 5, 6, 26 ... Addition Pressure member, 5a, 6a, 26a ... Pressurizing part, 6b, 26b ... Conical surface

Claims (10)

A medical member having a structure in which a tubular material and a connecting body connected to an opening end on one side in the axial direction of the tubular material are joined.
The connecting body is integrally formed with a pipe end contact portion that is in contact with the opening end portion on one side of the tubular material in the axial direction and the pipe end contact portion. Or, it is fixed and is housed inside the tubular material, and is integrated with the pipe end contacting portion and the in-pipe arrangement portion provided with an annular groove at a position facing the inner peripheral surface of the tubular material. It has a tubular outer covering portion that is configured, fixed to, or abutted at least toward the one side in the axial direction and mounted on the outer periphery of the tubular material.
The other end edge of the outer tube covering portion opposite to the one side is plastically deformed diagonally inward toward the one side over the entire circumference, so that the other end edge becomes the outer peripheral surface of the tubular material. On the other hand, a medical member characterized in that a part of the inner peripheral surface of the tubular material is inserted into the inside of the annular groove as well as being recessed in an annular shape. The position in the axial direction in which the end edge of the outer covering portion of the pipe with respect to the outer peripheral surface of the tubular material bites is included in the axially formed region of the annular groove provided in the arrangement portion in the pipe. , Which is separated from any of the positions of both side edges of the annular groove in the axial direction.
The medical member according to claim 1. Regarding the shape of the side edges of the annular groove on both sides in the axial direction, the inclination of the one side edge with respect to the axial direction is relatively small, and the inclination of the other side edge with respect to the axial direction is relatively large.
The medical member according to claim 1 or 2. The base end portion on the other side arranged inside the tubular material corresponds to the arrangement portion in the pipe, and the needle tube is led out from the inside of the opening end portion on the one side of the tubular material and extends to the one side. Equipped with
The medical member according to any one of claims 1 to 3. A fitting groove is formed on the outer peripheral surface of the needle tube at a position facing the inner peripheral surface of the tube end contact portion on one side of the annular groove, and the end surface of the tube end contact portion on the one side. Due to the plastic deformation in which the concave portion is formed in the pipe end, a part of the inner peripheral surface of the pipe end contact portion has entered the inside of the fitting groove.
The medical member according to claim 4. The pipe end contact portion and the pipe outer coating portion are configured as separate bodies, and a step structure that opens toward the other side is provided on the outer peripheral portion of the pipe end contact portion. The one-sided end is engaged in a state of being arranged on the support surface under the step of the step structure, and the one-side end abuts on the step of the step structure.
The medical member according to any one of claims 1 to 5. A method for manufacturing a medical member having a structure in which a tubular material and a connecting body connected to an opening end on one side in the axial direction of the tubular material are joined.
The connecting body is integrally formed with a pipe end contact portion that is in contact with the opening end portion on one side of the tubular material in the axial direction and the pipe end contact portion. Or, it is fixed and is housed inside the tubular material, and is integrated with the pipe end contacting portion and the in-pipe arrangement portion provided with an annular groove at a position facing the inner peripheral surface of the tubular material. It has a tubular outer covering portion that is configured, fixed to, or abutted at least toward the one side in the axial direction and mounted on the outer periphery of the tubular material.
By pressurizing with a conical surface that is inclined with respect to the axial direction, the edge of the outer coating portion on the other side opposite to the one side is plastically deformed diagonally inward toward the one side over the entire circumference. The medical treatment is characterized in that the other end edge is annularly inserted into the outer peripheral surface of the tubular material, and a part of the inner peripheral surface of the tubular material is inserted into the annular groove. Manufacturing method of parts. The position in the axial direction in which the end edge of the outer covering portion of the tube is embedded with respect to the outer peripheral surface of the tubular material is included in the axially formed region of the annular groove provided in the arrangement portion in the pipe. , Which is separated from any of the positions of both side edges of the annular groove in the axial direction.
The method for manufacturing a medical member according to claim 7. Regarding the shape of the side edges of the annular groove on both sides in the axial direction, the inclination of the one side edge with respect to the axial direction is relatively small, and the inclination of the other side edge with respect to the axial direction is relatively large.
The medical member according to claim 7 or 8. The angle of inclination of the conical surface with respect to the axial direction is in the range of 3 to 30 degrees.
The method for manufacturing a medical member according to any one of claims 7 to 9.

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