JP2021145885A - Medical component and manufacturing method of the same - Google Patents

Abstract

[Problem] A medical component having a joint structure for connecting other components to various tubular materials, which satisfies various requirements imposed on medical components while suppressing the external dimensions. [Solution] A structure in which a tubular material is joined to a connector connected to an open end provided on one side in the axial direction of the tubular material, the connector having an in-tube placement part that is accommodated and disposed inside the tubular material and has an annular groove, and a cylindrical outer tube covering part that is directly or indirectly integrally formed with or fixed to the in-tube placement part, or that abuts at least toward the one side in the axial direction, and is attached to the outer periphery of the tubular material, and the other side edge 4c of the outer tube covering part, which is provided with an annular protrusion protruding toward the outer periphery, is plastically deformed obliquely inwardly toward the one side over the entire circumference, so that the other side edge is annularly embedded into the outer periphery surface 3a of the tubular material, and a part of the inner periphery surface of the tubular material is inserted into the annular groove. [Selected Figure] 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.

On the other hand, in medical members, restrictions are often imposed on the external dimensions of various tubular materials from the viewpoint of insertion into the patient's body, and the joint structure for connecting other members to this tubular material is also restricted. Similar to tubular materials, reduction of external dimensions is required.

The present invention solves the above-mentioned problems, and the problem is various impositions on medical members while suppressing external dimensions in medical members having a joint structure for connecting other members to various tubular materials. It is an object of the present invention to provide a medical member having a joint structure capable of satisfying a demand.

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 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 is directly or indirectly relative to the in-pipe arrangement 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. An annular protrusion that protrudes to the outer peripheral side is provided, and the edge of the outer covering portion on the other side opposite to the one side reduces the amount of protrusion of the protrusion to the outer peripheral side. By being plastically deformed diagonally inward to one side over the entire circumference, the edge of the other side 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 said. It is characterized by entering the inside of the annular groove. 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 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 directly or directly with respect to the in-pipe arrangement portion. Indirectly, a tubular outer covering portion that is integrally formed, fixed, or abuts toward at least one side in the axial direction and is mounted on the outer periphery of the tubular material. A mode in which the end edge of the outer covering portion of the pipe on the other side opposite to the one side is provided with an annular protrusion protruding toward the outer peripheral side, so that the amount of protrusion of the protrusion toward the outer peripheral side is reduced. Then, the protrusion is pressurized by a conical surface inclined with respect to the axial direction, and the other end edge of the outer tube covering portion is plastically deformed diagonally inward toward the one side over the entire circumference. 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, in a state where one end of the tubular material is arranged between the inner pipe arrangement portion and the outer pipe covering portion, the other end edge of the outer pipe covering portion is annularly formed diagonally inward over the entire circumference. It is plastically deformed to form an annular shape with respect to the outer peripheral surface of the tubular material, and a part of the inner peripheral surface of the tubular material enters the inside of the annular groove. It is possible to construct a joint structure having high properties, high joint strength, and high stability. 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. At this time, by providing an annular protrusion projecting to the outer peripheral side on the other end edge of the outer covering portion of the pipe, the other end edge can be easily plastically deformed in an annular shape at the time of manufacturing, and the outer circumference of the tubular material is easily deformed. Increasing the amount of biting into the surface or improving the biting mode, and as a result, increasing the amount of biting into the annular groove of a part of the inner peripheral surface of the tubular material or improving the biting mode causes the joint structure. The airtightness, joint strength, and stability can be further improved. Further, at this time, by pressurizing the annular protrusion to plastically deform the other end edge of the outer covering portion of the pipe, the amount of protrusion of the protrusion itself to the outer peripheral side is also reduced, so that the protrusion is provided. As a result, the increase in the external dimensions of the joint structure is suppressed or does not occur.

In the present invention, the tubular material is configured such that the external dimension of the axial region arranged on the inner peripheral side of the outer covering portion of the pipe is smaller than the region arranged on the other side of the axial region. It is preferable to be done. As a result, the external dimensions of the connecting portion structure can be reduced, so that it becomes easy to reduce the diameter of the entire medical member. At this time, by making the external dimension of the protrusion before the plastic deformation larger than the external dimension of the region arranged on the other side, a pressing force for causing the plastic deformation from the other side to the protrusion. It also becomes easy to give. Further, in order to suppress an increase in the external dimension of the joint structure, the external dimension (outer diameter) of the portion other than the other end edge of the pipe outer coating portion is set to the inside of the pipe outer coating portion of the tubular material. It is more desirable that the external dimension (outer diameter) of the region arranged on the other side of the axial region arranged on the circumferential side is the same as or smaller than that. Further, it is desirable that the outer peripheral surface of the outer covering portion of the pipe is formed flat including the other end edge. This means that the amount of protrusion of the protrusion, which had protruded to the outer peripheral side before the plastic deformation, is substantially eliminated by the plastic deformation. Even in this case, since the inner peripheral corner of the other end edge after plastic deformation is embedded in the outer peripheral surface of the tubular material, the other end edge has a thick portion corresponding to the protrusion before plastic deformation. Will remain substantially.

In the present invention, the outer covering portion of the pipe is integrally configured with the inner placement portion of the tubular material via a pipe end connecting portion arranged on the one side of the opening end portion of the tubular material on one side. It is preferable that the lumber is fixed, or at least abuts toward the one side in the axial direction. At this time, it is desirable that the open end portion on one side of the tubular material comes into contact with the pipe end connecting portion toward the one side in the axial direction. As a result, the axial deviation between the components in the joint structure can be suppressed, so that the joint strength can be further improved.

In each of the above inventions, the protrusion before plastic deformation has an annular other-side inclined surface region configured to incline diagonally outward toward the other side on the other side in the axial direction, and the axis. On one side of the direction, either between the annular one-sided inclined surface region configured to incline diagonally outward toward the one side, the other-sided inclined surface region, and the one-sided inclined surface region. It is preferable to have an annular central surface region which is formed adjacent to each other and has a smaller inclination angle with respect to the axial direction than any of the other side inclined surface region and the one side inclined surface region. By providing the other side inclined surface region and the one side inclined surface region on both sides of the low inclined central surface region in the axial direction, the other side of the outer covering portion of the pipe can be pressurized by applying pressure from either one side or the other side. When the end on the side is plastically deformed, a stable mode of plastic deformation can be realized, and the outer peripheral surface near the other end edge of the outer covering of the pipe after the plastic deformation can be easily flattened. It is possible to easily flatten the outer shape of the structure and reduce the outer dimensions.

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 open 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 connecting portion, and a recess is formed on the one end surface of the tube end connecting portion. Therefore, it is preferable that a part of the inner peripheral surface of the pipe end connecting portion enters the inside of the fitting groove. According to this, even if the pipe end connection 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. It has the advantage that it does not easily affect the characteristics.

In the present invention, it is preferable that the pipe end connecting portion and the pipe end arranging portion are composed of 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 connecting portion and the pipe outer covering portion are separate bodies.

In the present invention, the pipe end connecting portion and the pipe outer covering portion may be integrally formed. Further, the pipe end connecting portion and the pipe outer covering portion may be configured as separate bodies. When the pipe end connection portion and the pipe outer coating portion are separately configured, a step structure open toward the other side is provided on the outer peripheral portion of the pipe end connection portion, and the pipe outer coating portion is provided. It is desirable that the end portion on one side of the above is engaged in a state of being arranged on the support surface under the step of the step structure, and the end portion on the one side abuts on the step of the step structure. According to this, 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 connection portion, and the end of the one side is the step of the step structure. Even if the pipe end connecting portion and the pipe outer covering portion are separated from each other, the engagement state between the two can be stabilized, so that the bonding process between the tubular material and the connecting body can be easily carried out. , 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. Further, the inclination angles φa and φb with respect to the axial direction of the other side inclined surface region or the one side inclined surface region of the protrusion subjected to the pressure by the conical surface corresponding to the inclination angle are 15 to 45 degrees. It is preferably within the range, particularly preferably within the range of 20-40 degrees. Further, the inclination angles φb and φa with respect to the axial direction of the one-side inclined surface region or the other-side inclined surface region on the side opposite to the side receiving pressure from the conical surface shall be within the range of 5 to 15 degrees. Is desirable.

In the present invention, the axial position of the other end edge of the outer covering portion of the pipe with respect to the outer peripheral surface of the tubular material is the axial formation of the annular groove provided in the inner arrangement portion of the pipe. It is preferable that the annular groove is included in the region and is 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 (angle) of the side edge on one side with respect to the axial direction is relatively small, and the inclination (angle) of the side edge on the other side with respect to the axial direction is relatively small. The inclination (angle) is preferably relatively 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 having a joint structure for connecting a connecting body to a tubular material, the medical member having a joint structure capable of satisfying various requirements imposed on the medical member while suppressing external dimensions. Can be provided.

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 2b of the needle tube 2 and the tip end portion 3b 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) on one side (left side in the drawing) in the axial direction from the inside of the flexible tube 3 on the outer peripheral surface 2a, and the pipe end connecting portion 4a. A fitting groove 2d is formed at a position facing the inner peripheral surface 4d). 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.

The flexible tube 3 corresponds to the tubular material. In the present embodiment, the flexible tube 3 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. Further, in the present embodiment, the external dimension (outer diameter in the illustrated example) of the tip portion 3b of the flexible tube 3 is the external dimension (outside in the illustrated example) of the region on the other side (right side in the drawing) of the tip portion 3b. It is configured to be smaller than the diameter). For example, it is desirable that the outer dimension (outer shape) of the tip portion 3b is configured to be smaller within the range of 5.0 to 25.0% than the outer dimension (outer shape) of the region on the other side. .. Further, the in-pipe arrangement portion (base end portion 2b) is preferably 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 the base end portion 2b is in a state of being pressed against the inner peripheral surface 3d 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 is arranged on one side of the end of the flexible tube 3 which is a tubular material, and in the illustrated example, the contact surface that abuts on the open end 3c of the tip 3b of the flexible tube 3. An annular pipe end connecting portion 4a provided with 4p and an annular pipe end connecting portion 4a arranged on the other side of the axial direction in the direction of the axis Jx (hereinafter, simply referred to as "axis direction") with respect to the pipe end connecting portion 4a from one side. It has a tubular (cylindrical in the illustrated example) outer tube covering portion 4b that abuts and covers the tip portion 3b of the flexible tube 3 from the outer peripheral side thereof. In the illustrated example, the pipe end connecting portion 4a and the pipe outer covering portion 4b are integrally formed. However, as in the second embodiment described later, the pipe end connecting portion 4a and the pipe outer covering portion 4b may be configured as separate bodies so as to be in contact with each other in the axial direction. When the pipe end connecting portion 4a and the pipe outer covering portion 4b are integrally formed, the joining block 4 is preferably made of a metal such as stainless steel. Further, when the pipe end connecting portion 4a and the pipe outer covering portion 4b are separately configured, the pipe end connecting portion 4a may be made of metal or resin, but the pipe end covering portion 4b may be made of metal. preferable. In the present embodiment, the open end portion 3c and the contact surface 4p may not come into contact with each other, and a gap may exist between them.

In the present embodiment, an annular protrusion 4ct is formed on the other end edge 4c of the outer covering portion 4b in the axial direction. In the illustrated example, the protrusion 4ct is integrally formed with the outer covering portion 4b of the pipe, but is fixed to the other end edge 4c of the outer covering portion 4b by various methods such as adhesion, joining, and welding. It may be the one. As shown in the upper right of FIG. 2, the protrusion 4ct has a shape in which the other end edge 4c of the outer covering portion 4b of the pipe is projected toward the outer peripheral side of the outer peripheral surface of the other portion on one side in the axial direction. And. The protrusion 4ct is formed on the other side in the axial direction and is formed on one side in the axial direction with respect to the annular other side inclined surface region 4cta which is inclined obliquely outward toward the other side and the other side inclined surface region 4cta. An annular one-sided inclined surface region 4ctb inclined obliquely outward toward one side, and formed adjacent to each other between the other-side inclined surface region 4cta and the one-side inclined surface region 4ctb. , An annular central surface region 4 ctp having a smaller inclination angle with respect to the axial direction than any of the inclined surface regions on both sides. It is desirable that the protrusion 4ct has a rotating body shape having the same cross-sectional shape around the axis.

Although the pipe end connecting portion 4a is different from the illustrated example, it is preferable that the corner portion 4h between the outer peripheral side and the end surface 4e on one side thereof 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 connecting portion 4a) is attached to the outer circumference of the base end portion 2b of the needle tube 2, and the tip end portion 3b of the flexible tube 3 is not arranged. It may be in a state. 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, with the pipe end connecting portion 4a of the needle tube 2 and the joining block 4 overlapping inside and outside in the radial direction, a pressurizing member (punch) 5 provided with an annular pressurizing portion 5a around the axis is axised. It acts on the end surface 4e on one side of the joining block 4 from one side in the 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 suffices if the (arranged portion in the pipe) and the joining block 4 (tube end connecting portion 4a) are securely fixed. For example, by forming the fitting groove 2d discontinuously in the circumferential direction, the tube end connecting 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 as shown in the illustrated example so that a part 4g of the inner peripheral surface 4d of the pipe end connecting portion 4a easily flows into the inner fitting groove 2d. In addition, it is preferable to form the inner side surface on the inner side in the radial direction so that the inclination angle on 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.

In the present embodiment, the external dimension of the protrusion 4ct (outer diameter in the illustrated example) is larger than the external dimension (outer diameter in the illustrated example) of the region on the other side of the tip portion 3b in the flexible tube 3 in the axial direction. It is set large. As a result, the pressurizing member 6 is moved from the side of the other side region of the flexible tube 3 to one side, and the pressurizing portion 6a having an inner diameter larger than the outer dimension (outer diameter) of the other side region is used. , It becomes possible to apply a pressing force to the protrusion 4ct. Due to this pressing force, the edge 4c is plastically deformed diagonally inward to one side in a state where the pressing portion 6a is in contact with the protrusion 4ct. Here, in order to appropriately cause plastic deformation, it is preferable to pressurize toward one side as shown in the illustrated example. When the pressurizing portion 6a is moved from one side in the axial direction to the other side and a pressing force is applied toward the other side in the axial direction, the external dimensions (outer diameter) of the protrusion 4ct before plastic deformation are possible. It does not have to be larger than the external dimension (outer diameter) of the region on the other side of the flexible tube 3. However, even in this case, as a result, if the external dimension of the protrusion 4ct before plastic deformation is increased, the amount of plastic deformation of the edge 4c on the other side is likely to be increased, and the final joint strength is improved. It is advantageous in that it can be done. Further, regardless of which side the pressing force is applied to, the amount of protrusion of the protrusion 4ct is reduced by the plastic deformation. Therefore, the external dimensions of the edge 4c after the plastic deformation are set to the other side of the flexible tube 3. Since it can be suppressed to be substantially equal to or less than the external dimension of the region, the disadvantage that the external dimension of the protrusion 4ct before plastic deformation is larger than the external dimension of the region on the other side of the flexible tube 3 is limited. it is conceivable that.

Due to the above plastic deformation, the protrusion 4ct moves diagonally inward in the radial direction to one side in the axial direction, so that the amount of protrusion to the outer peripheral side is reduced. In the illustrated example, in the third step, the amount of protrusion 4ct of the protrusion 4ct with respect to the outer peripheral surface of the other portion of the outer tube covering portion 4b decreases due to the plastic deformation, but the other outer covering portion 4b Although the amount is small as compared with the portion, the protruding state with respect to the outer peripheral surface may remain. At this time, in the outer covering portion 4b after the third step, as shown in FIG. 6, a slight protrusion 4ct'is seen on the edge 4c on the other side. However, the protrusion 4ct'may be plastically deformed so as not to remain on the outer peripheral surface of the outer covering portion 4b due to the radial position of the pressurizing portion 6a or the stroke in the axial direction.

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 angle of the edge 4c is as shown in FIG. When the portion 4i is inserted into the outer peripheral surface 3a of the flexible tube 3, the flexible tube 3 is locally deformed in an annular shape inward in the radial direction over the entire circumference, and the inner peripheral surface 3d inside the deformed region is deformed. A part of 3e enters the inside of the annular groove 2c over the entire circumference. 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 axial position of the axial side edge of the annular groove 2c, and these positions are located. There is an interval for both. 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 tube outer coating 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 of the above components 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 connecting portion 4a of the joining block 4 fixed to the needle tube 2 abuts in the axial direction with respect to the opening end portion 3c of the flexible tube 3. 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 machined accurately and reliably. However, as described above, the open end portion 3c on one side and the contact surface 4p may not come into contact with each other, and a gap may exist between them. 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 edge 4c on the other side is crimped, as a result, the crimping direction is not inward in the radial direction but diagonally inward to one side, so that the resistance to deformation is reduced and the amount of deformation is increased. Since it is easy to do so, it is easy to secure the amount of biting into the flexible tube 3 and the amount of biting into the annular groove 2c of a part 3e of the flexible tube 3, so that a reliable joining state can be easily obtained. It should be noted that these points are the same in other embodiments described later.

In the present embodiment, a protrusion 4ct protruding toward the outer periphery is formed on the other end edge 4c of the outer covering portion 4b, and the protrusion 4ct is pressed by the pressurizing portion 6a to cause plastic deformation, and as a result, the result is The amount of protrusion 4ct is reduced. As a result, the edge 4c can be further deformed diagonally inward, so that the amount of biting of the inner corner portion 4i with respect to the surface 3a of the flexible tube 3 based on plastic deformation can be increased and the biting mode can be improved. As a result, the joint strength of the joint structure can be increased. The amount of plastic deformation may be increased so that the protrusion 4ct'does not remain on the outer periphery of the edge 4c after plastic deformation. However, even in this case, as compared with the case where the protrusion 4ct is not provided, as shown in FIG. 6, the edge 4c is depressed toward the inner peripheral side of the outer peripheral edge with respect to the biting amount of the inner corner portion 4i. Therefore, it can be considered that the protrusion 4ct'is substantially contained even in the edge 4c after the plastic deformation.

The cross-sectional shape of the protrusion 4ct before the plastic deformation is configured so that the contour line seen in the axial direction is curved over the entire formation range in the axial direction. That is, when the cross-sectional shape of the protrusion 4ct is viewed along the axial direction, the surface of the protrusion 4ct rises in a curve from the other side inclined surface region 4cta to the peak position of the central surface region 4ctp, and the peak of the central region 4ctp. It descends in a curved line from the position over the one-sided inclined surface region 4ctb. At this time, when comparing the inclination from the other side in the axial direction to the peak position and the inclination from the peak position to one side, the former is steeper than the latter as a whole. Instead of this protrusion 4ct, a protrusion 4cs shown in an enlarged manner at the lower left of FIG. 5 may be formed. Each of the protrusions 4cs includes an annular other side inclined surface region 4csa in which the contour line viewed in the axial direction appears linearly, an annular one side inclined surface region 4csb, and an annular central surface region 4csp. In this way, when the protrusions 4ct and 4cs are pressed from the other side or one side in the axial direction, the edge 4c on the other side of the outer covering portion 4b can be smoothly pressed diagonally inward. Uniform plastic deformation is realized over the circumference, and the airtightness, joint strength, and stability can be further improved. Further, since the protrusions 4ct and 4cs are inclined on the side opposite to the pressurizing side in the axial direction, the vicinity of the edge 4c of the outer covering portion 4b after the plastic deformation is easily flattened and joined. The outer shape of the part structure can be smoothed. At this time, as shown below, the inclination of the pressurized side (the other side in the illustrated example) of the protrusions 4ct and 4cs before the plastic deformation in the axial direction is opposite to the axial direction (one side in the illustrated example). It is preferable that it is larger than the inclination of the part as a whole.

The inclination angle φa with respect to the axial direction of the other side inclined surface regions 4cta and 4cta of the protrusions 4ct and 4cs and the inclination angle φb with respect to the axial direction of the one side inclined surfaces 4ctb and 4csb are relative to the axial direction of the central surface regions 4ctp and 4csb. It is configured to be larger than the inclination angle φc. At this time, the inclination angles φa and φb are both preferably in the range of 5 to 45 degrees. However, as in the present embodiment, when the pressurizing portion 6a abuts on the other side inclined surface regions 4cta and 4csa, the inclination angle φa of the other side inclined surface regions 4cta and 4csa is within the range of 15 to 45 degrees. It is preferably in the range of 20 to 40 degrees. In particular, it is more desirable to be in the range of 25 to 35. On the other hand, the inclination angles φb of the inclined surface regions 4ctb and tcsb on one side opposite to the side with which the pressurizing portion 6a abuts are preferably in the range of 5 to 15 degrees. The above range of the inclination angle φa is preferable for stably and surely causing the plastic deformation of the edge 4c, and the above range of the inclination angle φb flattens (or protrusions) the outer peripheral surface of the edge 4c after the plastic deformation. (Reduces the amount of protrusion of 4ct') is preferable. Here, contrary to the above, the pressurizing portion 6a may be brought into contact with the pressure portion 6a from one side, and in this case, it is preferable that the above ranges of the inclination angles φa and φb are opposite to each other. Here, in the curved protrusion 4ct as in the present embodiment, the boundary of each region becomes unclear, but the numerical value of the inclination angle is the case where the central surface region 4ctp is a region having an inclination angle of 3 degrees or less. Is assumed.

In the present embodiment, the tube is provided with the tip 3b (one end) of the flexible tube 3 (tubular material) arranged between the base end 2b (internal arrangement) and the outer covering 4b. The other end edge 4c of the outer coating portion 4b is plastically deformed obliquely inward over the entire circumference so as to fit into the outer peripheral surface of the flexible tube 3 in an annular shape, so that heating or adhesion is not used. In addition, a joint structure having high airtightness, high joint strength, and high stability can be constructed. 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. At this time, by providing the annular protrusions 4ct and 4cs protruding toward the outer periphery on the other end edge 4c of the outer covering portion 4b, the other end edge 4c can be easily plastically deformed in an annular shape during manufacturing. , The amount of biting into the outer peripheral surface 3a of the flexible tube 3 is increased or the biting mode is improved, and as a result, the amount of biting into the annular groove 2c of a part 3e of the inner peripheral surface 3d of the flexible tube 3 is caused. It is possible to further improve the airtightness, joint strength, and stability in the joint structure by increasing the number of the joints or improving the penetration mode. At this time, by pressurizing the annular protrusions 4ct and 4cs to plastically deform the other end edge 4c of the outer covering portion 4b, the protrusions 4ct'after the plastic deformation protrude to the outer peripheral side. Since the amount is reduced, the increase in the external dimensions of the joint structure is suppressed.

In the present embodiment, in the flexible tube 3, the outer dimension of the tip portion 3b, which is an axial region arranged on the inner peripheral side of the tube outer coating portion 4b, is further outer-tube coating than the axial region. Since the external dimensions of the connecting portion structure can be reduced by making the region smaller than the region arranged on the other side of the portion 4c, it becomes easy to reduce the diameter of the entire medical member. At this time, by making the external dimensions of the protrusions 4ct and 4cs before the plastic deformation larger than the external dimensions of the region arranged on the other side, the plastic deformation is caused from the other side with respect to the protrusions 4ct and 4cs. It is also possible to give a pressing force for this. Here, in order to suppress an increase in the external dimension of the joint structure, the external dimension (outer diameter) of the portion other than the forming region of the protrusions 4ct, 4cs, 4ct'of the outer covering portion 4b is a flexible tube. It is more desirable that the external dimension (outer diameter) of the region arranged on the other side of the tip portion 3b of 3 is the same as or smaller than that. Further, it is desirable that the outer peripheral surface of the outer tube covering portion 4b is formed flat including the other end edge 4c as shown in the illustrated example. At this time, since the amount of protrusion of the protrusion 4ct'after plastic deformation to the outer periphery is substantially eliminated, the external dimensions of the joint structure can be further suppressed.

In the present embodiment, the outer covering portion 4b is arranged on the one side of the opening end 3c on the one side of the flexible tube 3 with respect to the base end portion 2b (arranged portion in the pipe). The joint structure can be made into a simple structure and its outer shape by being integrally formed or fixed via the connecting portion 4a, or by abutting at least toward the one side in the axial direction. The dimensions can be suppressed. At this time, the open end portion 3c on one side of the flexible tube 3 abuts against the pipe end connecting portion 4a toward one side in the axial direction, so that the components in the joint structure are separated from each other. Since the axial deviation (in the illustrated example, the positional deviation of the flexible tube 3 to one side in the axial direction) can be suppressed, the joint strength can be further improved. The points described in the above six paragraphs are basically the same in the following other embodiments.

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 connecting portion 14a and the pipe outer covering portion 14b corresponding to the joining 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 connecting portion 14a is on the outer peripheral portion on the other side in the axial direction, that is, on the outer peripheral side of the contact surface 14p with which the open end portion 13c of the flexible tube 13 abuts. , The step structure 14j is formed. The step structure 14j includes a step surface 14jx formed between the outer peripheral portion of the pipe end connecting 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 connection portion 14a. 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 connection portion 14a due to hitting the pipe end 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 connection portion 14a to form the recess 14f, and the inner peripheral surface thereof is deformed by the composition modification of the pipe end connection portion 14a. The tube end connecting portion 14a is fixed to the needle tube 12 by allowing a part 14g of the 14d to enter the inside of the fitting groove 2d. Further, in this state, by performing the same joining work as in the first embodiment, by pressurizing the protrusion 14ct, the other end edge 14c of the pipe outer covering portion 14b is diagonally inward to one side over the entire circumference. Plastically deform. Due to the plastic deformation of the edge 14c, the amount of protrusion of the protrusion 14ct'is reduced or does not protrude, and 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. 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. Even when the protrusion amount of the protrusion 14ct disappears, the point that the protrusion 14ct'remains substantially in the edge 14c is the same as that of the previous embodiment.

In the present embodiment, the pipe end connecting portion 14a and the pipe outer covering 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 stepped structure 14j. The joining work can be facilitated, for example, the outer covering portion 14b can be attached at an appropriate timing. For example, initially, only the tube end connecting portion 14a is attached to the needle tube 12 to perform mutual joining work, and then the tip end portion 13b of the flexible tube 13 and the outside of the tube are attached to the base end portion 12b of the needle tube 12. The covering portion 14b can also be fitted externally. Further, by separating the pipe end connecting portion 14a and the pipe outer covering portion 14b, these can be made of different materials from each other. For example, by forming the pipe end connecting portion 14a with a resin material and the pipe outer coating portion 14b with a metal material, the pipe end connecting portion 14a and the needle tube 12 can be fixed by a method other than plastic flow, for example, bonding with an adhesive. It can also be done by a method or the like. This means that the optimum fixing method can be adopted according to the relationship between the materials of the pipe end connecting 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 and the selectivity 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 connecting 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. Moreover, instead of the protrusion 14ct having the same cross-sectional shape as the protrusion 4ct, a protrusion having the same cross-sectional shape as the protrusion 4cs may be formed.

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 is integrally configured (fixed) with the pipe end connecting portion 24a arranged on one side of the end portion of the flexible tube 23 which is a tubular material and the pipe end connecting portion 24a. It has an arrangement portion of 24 m. 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 connecting 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 coating portion 24b is engaged separately from the contact surface 24p with which the open end portion 23c of the flexible tube 23 abuts. A step structure 24j (dotted line in the figure) to be formed may be formed. An annular groove 24n is formed on the outer peripheral surface of the in-pipe arrangement portion 24m. The open end 23c does not come into contact with the contact surface 24p, and a gap may exist between the two.

In this embodiment, since the pipe end connecting portion 24a having the contact surface 24p and the pipe end arranging 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 connecting 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. 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 airtightly closed and the joint strength can be improved.

Also in this embodiment, protrusions 24cs are provided on the other end edge 24c of the outer covering portion 24b. Here, in the illustrated example, the protrusion 24cs similar to the protrusion 4cs is formed, but the protrusion similar to the protrusion 4ct may be formed. Further, by rounding or chamfering the corner portion 24h on the outer peripheral side on one side in the axial direction of the pipe end connecting portion 24a, it can be smoothly inserted into the body or the like. 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 providing the protrusions 24cs, the edge 24c of the outer covering portion 24b of the pipe can be appropriately and surely plastically deformed diagonally inward, and the joint portion is strong. The structure of 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 tubular materials, and the joining block 4 or the pipe end connecting portion 14a and the pipe outer covering portion 14b are connected to the needle tubes 2 and 12 as connecting bodies. 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 connecting portion, a pipe inner arrangement portion, and a pipe outer covering portion. can.

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 made deeper and wider as the thickness increases, and in this case, it is desirable that the thicknesses of the outer tube covering portions 4b, 14b and 24b are also increased.

Further, in each of the above embodiments, the protrusions 4ct, 4cs, 14ct, and 24cs are formed on the edge edges 4c, 14c, and 24c of the outer tube covering portions 4b, 14b, and 24b. However, the protrusions 4ct, 4cs, 14ct, and 24cs may be formed slightly apart from the edge edges 4c, 14c, and 24c on one side in the axial direction. That is, as a result, by pressurizing the protrusions 4ct, 4cs, 14ct, and 24cs, the edge edges 4c, 14c, and 24c may be plastically deformed diagonally inward.

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 part, 3c ... Open end part, 3d ... Inner peripheral surface, 3e ... Part, 4 ... Joint block, 4a ... Pipe end connection part, 4b ... Pipe outer coating part, 4c ... Edge edge, 4ct, 4cs, 14ct, 24cs ... protrusions, 4d ... inner peripheral surface, 4e ... end face, 4f ... recess, 4g ... part, 4h ... corner part, 4i ... inner corner part, 4j ... step structure, J ... joint part, Jx ... Axis, 5, 6, 26 ... Pressurizing 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 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 directly or indirectly with respect to the in-pipe arrangement 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 covering portion of the pipe, which is provided with an annular protrusion protruding toward the outer peripheral side, is such that the amount of protrusion toward the outer peripheral side of the protrusion is reduced. By being plastically deformed diagonally inward to the side over the entire circumference, 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 formed into the annular groove. A medical component characterized by being intruded into the inside of the body. The tubular material is configured such that the external dimension of the axial region arranged on the inner peripheral side of the outer tube covering portion is smaller than the axial region and further smaller than the region arranged on the other side.
The medical member according to claim 1. The external dimensions of the portion of the outer covering portion on the other side other than the edge on the other side are arranged on the other side of the axial region arranged on the inner peripheral side of the outer covering portion on the tubular material. Same as or smaller than the external dimensions (outer diameter) of the area,
The medical member according to claim 2. The outer peripheral surface of the outer covering portion of the pipe is formed flat including the other end edge.
The medical member according to any one of claims 1 to 3. The outer pipe covering portion is integrally formed with the inner pipe arrangement portion via a pipe end connecting portion arranged on the one side of the opening end portion on the one side of the tubular material, or is integrally formed with the pipe end covering portion. Fixed or abutting at least towards the one side in the axial direction,
The medical member according to any one of claims 1 to 4. The one-sided open end of the tubular material abuts against the tube-end connecting portion toward the one side in the axial direction.
The medical member according to claim 5. The pipe end connecting portion and the pipe outer covering portion are configured as separate bodies, and a step structure open toward the other side is provided on the outer peripheral portion of the pipe end connecting portion, and the one of the pipe outer covering portions is provided. The side end is engaged in a state of being arranged on the support surface under the step of the step structure, and the one end is in contact with the step of the step structure.
The medical member according to claim 5 or 6. The axial position of the other end edge of the outer covering portion of the tubular material 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 in-pipe arrangement portion. At the same time, it is separated from any of the positions of both side edges of the annular groove in the axial direction.
The medical member according to any one of claims 1 to 7. 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 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 directly or indirectly with respect to the in-pipe arrangement 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 end edge of the outer covering portion on the other side opposite to the one side is provided with an annular protrusion protruding toward the outer peripheral side.
In an embodiment in which the amount of protrusion to the outer peripheral side of the protrusion is reduced, the protrusion is pressed by a conical surface inclined with respect to the axial direction, and the other end edge of the outer tube covering portion is pressed on the other side. By plastically deforming diagonally inward over the entire circumference, 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 inside the annular groove. A method for manufacturing a medical member, which is characterized in that it is configured to enter. The tubular material is configured such that the external dimension of the axial region arranged on the inner peripheral side of the outer tube covering portion is smaller than the axial region and further smaller than the region arranged on the other side.
The method for manufacturing a medical member according to claim 9.

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