JP7521770B2 - Medical device and its manufacturing method - Google Patents

Description

The present invention relates to medical devices and their manufacturing methods.

Medical devices with at least a portion having a tubular structure, such as medical catheters and puncture needles, are tubular medical devices that are inserted into body cavities or the bladder, urethra, trachea, esophagus, stomach, large intestine, etc. to drain body fluids and other liquids or contents or to inject medicinal fluids, contrast media, etc., have been widely used. Medical devices of this type include those used in treatment-related medical devices (such as surgical catheters) and those used in diagnostic-related medical devices (such as endoscopes). In addition to those that are incorporated into medical devices, medical devices can also be used independently.

The above medical components may have a joint structure that connects another component to the resin tube, but because at least a portion of the component is introduced into the patient's body, it is necessary to ensure the stability of the entire component, including the joint structure, and the joining strength of the joint structure, and it is also necessary to configure the external dimensions as compact as possible. Medical components with such joint structures (such as medical catheters and puncture needles used in endoscopes) are known to be those described in the following Patent Document 1.

JP 2008-188304 A

In the medical catheter described in the above Patent Document 1, the distal tube 30A and the proximal tube 30B are joined at a joint 31, and the joining method used includes heat fusion and adhesion methods using various adhesives (see paragraphs 0153-0157). However, when heat fusion is used, there is a risk that the materials may be altered by heating, which may reduce the durability of the joint strength and lead to separation during use. Even when an adhesion method is used, depending on the combination of resin materials, sufficient adhesive strength may not be ensured in many cases, and adhesion strength may be further reduced when bonding resin and metal.

The present invention solves the above problems, and its objective is to provide a medical component with a joint structure that connects various tubular materials to other components, which achieves sufficient joint strength while preventing deterioration of the material and insufficient or reduced joint strength due to heating, and ensures stability and safety.

In order to solve the above problems, the medical component according to the present invention is a medical component having a structure in which a tubular material and a connector connected to an open end on one side in the axial direction of the tubular material are joined, and the connector has a tube end abutment portion that is in axial abutment with the open end on one side of the tubular material, an intra-tube arrangement portion that is integrally formed with or fixed to the tube end abutment portion, 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 a cylindrical outer tube covering portion that is integrally formed with or fixed to the tube end abutment portion, or abuts at least toward the one side in the axial direction, and is attached to the outer periphery of the tubular material, and is characterized in that the edge of the other side opposite to the one side of the outer tube covering portion is plastically deformed obliquely inwardly toward the one side over the entire circumference, so that the edge of the other side annularly bites into the outer peripheral surface of the tubular material, and a part of the inner peripheral surface of the tubular material enters inside the annular groove. Here, the tubular material is preferably made of a flexible material that contains a resin material.

Next, the method for manufacturing a medical component according to the present invention is a method for manufacturing a medical component having a structure in which a tubular material and a connector connected to one open end in the axial direction of the tubular material are joined, the connector comprising a tube end abutment portion that is in axial abutment with the one open end of the tubular material, an in-tube arrangement portion that is integrally formed or fixed to the tube end abutment portion 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 an in-tube arrangement portion that is integrally formed with the tube end abutment portion. The device has a cylindrical outer tube covering part that is configured, fixed, or abuts against at least the one side in the axial direction and is attached to the outer circumference of the tubular material, and is characterized in that it is configured such that the edge of the other side opposite to the one side of the outer tube covering part is plastically deformed diagonally inward toward the one side over the entire circumference by applying pressure with a conical surface inclined with respect to the axial direction, so that the edge of the other side annularly bites into the outer circumference of the tubular material and a part of the inner circumference of the tubular material enters inside the annular groove. Here, the tubular material is preferably configured of a flexible material including a resin material.

According to each of the above inventions, the other end edge of the outer tube covering the outer periphery of the tubular material is plastically deformed inwardly in an annular shape over the entire circumference, so that it is annularly embedded into the outer periphery of the tubular material, and a part of the inner periphery of the tubular material is inserted into the annular groove, so that a joint structure with high sealing performance, high joint strength, and high stability can be constructed without using heating or adhesive. Therefore, problems caused by heating or adhesive can be avoided, and medical components with higher stability and safety can be manufactured compared to conventional joint structures.

In the present invention, it is preferable that the base end portion of the other side arranged inside the tubular material corresponds to the in-tube placement portion, and that the needle tube is provided with a needle tube that is led out from the inside of the open end portion of the one side of the tubular material and extends to the one side. In this case, it is preferable that 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 abutment portion on the one side of the annular groove, and a part of the inner peripheral surface of the tube end abutment portion enters inside the fitting groove due to plastic deformation that forms a recess on the end face of the one side of the tube end abutment portion. With this, even if the tube end abutment portion and the in-tube placement portion are separate, they can be fixed together without using heating or adhesive, which has the advantage of ensuring the joining strength of the joint structure and being less likely to affect the properties as a medical device.

In the present invention, it is preferable that the tube end abutment portion and the tube internal placement portion are configured as an integrated closing member that is attached to the open end portion on one side of the tubular material to close the opening. In this case, it is preferable that the tube end abutment portion and the tube outer covering portion are separate bodies.

In the present invention, the tube end abutment portion and the tube outer covering portion may be integrally formed. The tube end abutment portion and the tube outer covering portion may be separate. When the tube end abutment portion and the tube outer covering portion are separate, it is preferable that a step structure open toward the other side is provided on the outer periphery of the tube end abutment portion, and the end of the one side of the tube outer covering portion engages with the step of the step structure while being placed on a support surface below the step of the step structure, and the end of the one side abuts against the step of the step structure. According to this, the end of the one side of the tube outer covering portion abuts against the step of the step structure while being placed on the support surface below the step of the step structure of the tube end abutment portion, so that the engagement state of the two can be stabilized even if the tube end abutment portion and the tube outer covering portion are separate, and the joining process of the tubular material and the connector can be easily performed and a reliable joint structure can be easily formed.

In the present invention, the inclination angle of the conical surface with respect to the axial direction is preferably within a range of 3 to 30 degrees. In particular, the inclination angle is preferably within a 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 where the pressure direction of the pressure member is closer to the axial direction than to the radial direction, so that the edge on the other side can be deformed toward the tubular material on the inner circumference side without applying excessive axial compression to the outer tube coating, thereby increasing the axial tensile strength between the tubular material and the connector.

In the present invention, in the region of the tubular material where the in-pipe placement portion is disposed internally, it is desirable that the external dimensions of the tubular material be deformed outwardly due to the internal pressure of the in-pipe placement portion, and configured to be larger than other regions. In this way, the in-pipe placement portion configures the external dimensions of the tubular material to be larger than other regions, thereby increasing the adhesion between the tubular material and the in-pipe placement portion, and further improving the joint strength of the joint structure.

In the present invention, it is preferable that the axial position where the edge of the outer pipe covering portion penetrates into the outer circumferential surface of the tubular material is included in the axial formation region of the annular groove provided in the inner pipe arrangement portion and is separated from both axial side edge positions of the annular groove. In this way, when the other side edge of the outer pipe covering portion is plastically deformed obliquely toward the inner circumferential side, a part of the inner circumferential surface of the tubular material easily penetrates into the annular groove. In addition, the amount of penetration of the part of the inner circumferential surface of the tubular material into the annular groove is maximized at the axial position of the other side edge located at a position separated from both axial side edges of the annular groove, so that the engagement between the inner circumferential surface of the tubular material and the annular groove is optimized, and in particular, the axial tensile strength of the joint structure is improved.

In the present invention, with regard to the shape of the side edges on both sides of the annular groove in the axial direction, it is preferable that the inclination of the side edge on one side relative to the axial direction is relatively small, and the inclination of the side edge on the other side relative to the axial direction is 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 making the inclination of the side edge on one side small, it is possible to make it easier for a part of the inner peripheral surface of the tubular material to enter the annular groove, and by making the inclination of the side edge on the other side large, it is possible to increase the tensile strength in the axial direction of the tubular material and the connecting body when a part of the inner peripheral surface of the annular material enters the annular groove.

This invention provides a medical component having a joint structure that connects a connector to a tubular material, which can achieve sufficient joint strength and ensure stability and safety while preventing material deterioration and insufficient or reduced joint strength due to heating.

1 is a schematic diagram showing an overall configuration of a first embodiment of a medical device according to the present invention. 1 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component of a first embodiment after a first process. FIG. 1 is an enlarged partial cross-sectional view showing the structure of a joint J of the medical component of the first embodiment after a second process. FIG. 1 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a first embodiment before a third process. FIG. 10 is an enlarged partial cross-sectional view showing the structure of a joint J of the medical component of the first embodiment during a third step. FIG. 10 is an enlarged partial cross-sectional view showing the structure of a joint J of the medical component of the first embodiment after a third process. FIG. 10 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component of a second embodiment after a first process. FIG. 10 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a second embodiment after a third process. FIG. 11 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a third embodiment after a first step (second step). FIG. 11 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a third embodiment before a third process. FIG. 13 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a third embodiment during a third step. FIG. 13 is an enlarged partial cross-sectional view showing the structure of a joint J of a medical component according to a third embodiment after a third process. FIG.

Next, an embodiment of the present invention will be described in detail with reference to the attached drawings. First, with reference to FIG. 1, the overall configuration of an example of a medical member according to a first embodiment of the present invention, more specifically, various medical members constituting a puncture needle or a catheter, will be described. This embodiment shows an example of a medical member 1 which is a joint (puncture member) of a needle tube and a flexible tube used in a puncture needle used in, for example, an ultrasonic endoscope or other endoscope, or various catheters. This medical member 1 is formed by joining a needle tube 2 and a flexible tube 3 to which the needle tube 2 is connected at a joint J. The joint J has a joint structure in which the base end of the needle tube 2 and the tip end of the flexible tube 3 are joined using a 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 to collect tissue (cells) or inject medicine, and the tip is configured to be sharp. The base end 2b of the needle tube 2 is also open and is inserted into the tip 3b of the flexible tube 3. Considering its use as a puncture needle, the outer diameter of the needle tube 2 is preferably within the range of 0.3 to 1.2 mm, and particularly preferably within the range of 0.4 to 0.8 mm. The length of the needle tube 2 is preferably within the range of 6.0 to 20.0 mm, and particularly preferably within 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 2b inserted into the flexible tube 3. Here, the annular groove 2c is located on the outer peripheral surface 2a facing the inner peripheral surface 3d of the flexible tube 3. In addition, a fitting groove 2d is formed at a position on the outer surface 2a that protrudes from the inside of the flexible tube 3 to one side in the axial direction (the left side in the figure) (a position offset to one side from the base end 2b and facing the inner surface 4d of the tube end abutment portion 4a). In this embodiment, the base end 2b of the needle tube 2 corresponds to the in-tube portion that is accommodated and disposed inside the flexible tube 3. In addition, the flexible tube 3 corresponds to a tubular material.

The flexible tube 3 corresponds to the above-mentioned tubular material, and in this embodiment, is made of synthetic resin such as fluororesin (PFA) or polyethylene (PE). The outer diameter of the flexible tube 3 is preferably within the range of 0.5 to 2.0 mm, and more preferably within 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 or catheter, but may exceed 1000 mm. The flexible tube 3 has flexibility that allows it to bend along the axial direction, but preferably has elasticity that allows it to be deformed in the radial direction as well. For example, when the outer diameter of the base end 2b of the needle tube 2 is somewhat larger than the inner diameter of the flexible tube 3, it is desirable to configure the outer diameter of the tip end 3b of the flexible tube 3 into which the base end 2b of the needle tube 2 is inserted to be somewhat larger (for example, within the range of 1.0 to 10.0%) than the outer diameter of the other side (right side in the figure) of the flexible tube 3 into which the needle tube 2 is not inserted. That is, it is preferable that the portion disposed within the tube (base end 2b) is in close contact with the inner peripheral surface 3d of the tubular material (flexible tube 3), and in particular, that it is in a state of being pressed against it by some force (the elastic force of the flexible tube 3 in the illustrated example).

At the joint J, the needle tube 2 and the flexible tube 3 are joined by the joint block 4. The joint block 4 has an annular tube end abutment 4a having an abutment surface 4p that abuts against the open end 3c of the tip 3b of the flexible tube 3, and a tubular (cylindrical in the illustrated example) tube outer covering portion 4b that is arranged on the other side of the axial direction of the axis Jx (hereinafter simply referred to as the "axial direction") of the tube end abutment 4a and abuts from one side, covering the tip 3b of the flexible tube 3 from its outer periphery. In the illustrated example, the tube end abutment 4a and the tube outer covering portion 4b are integrally formed. However, as in the second embodiment described later, the tube end abutment 4a and the tube outer covering portion 4b may be formed separately and be in a state of abutting each other in the axial direction. When the tube end abutment 4a and the tube outer covering portion 4b are integrally formed, it is preferable that the joint block 4 is made of a metal such as stainless steel. In addition, when the tube end abutment portion 4a and the tube outer covering portion 4b are constructed separately, the tube end abutment portion 4a may be made of metal or resin, but it is preferable that the tube outer covering portion 4b be made of metal.

It is preferable that the corner 4h between the outer periphery and the end face 4e on one side of the tube end abutment 4a is rounded or chamfered. By rounding or chamfering the corner 4h on the tip side on one side when inserting the medical device 1 into the body, it is possible to give the medical device a shape that is easy to introduce into various places.

Figure 2 is an enlarged partial cross-sectional view showing an example of the state in which the first step of the manufacturing process for joining the needle tube 2 and the flexible tube 3 of the medical device 1 has been completed. In this first step, the base end 2b of the needle tube 2 is inserted inside the tip end 3b of the flexible tube 3, and the joint block 4 is fitted from the outside between the base end 2b and the tip end 3b. However, in this state, the needle tube 2 and the flexible tube 3 are not joined, and the structure of the joint J is not shown to be completed. In addition, the state shown in Figure 2 shows an example of the state before the first step is completed and the second step described later is started, but is not limited to this. For example, the state in which the first step is completed may be a state in which only the joint block 4 (tube end abutment portion 4a) is attached to the outer periphery of the base end 2b of the needle tube 2, and the tip end 3b of the flexible tube 3 is not arranged. In this case, after the second step is completed and before the third step is performed, it is necessary to insert the tip end 3b of the flexible tube 3 between the base end 2b of the needle tube 2 and the outer tube coating part 4b of the joint block 4.

Figure 3 is an enlarged partial cross-sectional view showing the state where the second step of the manufacturing process is completed. In this second step, with the needle tube 2 and the tube end abutment portion 4a of the joint block 4 overlapping radially inside and outside, a pressing member (punch) 5 having an annular pressing portion 5a around the axis is applied to one end face 4e of the joint block 4 from one side in the axial direction. As a result, in the joint block 4, an annular recess 4f is formed on the end face 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, causing plastic deformation. As a result, the needle tube 2 and the joint block 4 are firmly fixed. In the illustrated example, the fitting groove 2d, the pressing portion 5a, and the recess 4f are all formed in a ring shape around the axis, but the present invention is not limited to such a ring shape, and as a result, it is sufficient that the needle tube 2 (pipe internal placement portion) and the joint block 4 (pipe end abutment portion 4a) are securely fixed. For example, by forming the fitting groove 2d discontinuously in the circumferential direction, the tube end abutment portion 4a and the needle tube 2 can be fixed around the axis as well.

In the second step, the protruding shape of the pressure section 5a is preferably formed so that the angle of inclination of the inner surface on the radially inner side relative to the axial direction is greater than the angle of inclination of the outer surface on the radially outer side relative to the axial direction, as in the illustrated example, so that a portion 4g of the inner circumferential surface 4d of the tube end abutment section 4a can easily flow into the inside of the inner fitting groove 2d.

Figure 4 is an enlarged partial cross-sectional view showing the state before the start of the third step. In the third step, a pressure member 6 having an annular pressure portion 6a is used. The surface (pressure surface) of the pressure 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 more preferably in the range of 3 to 30 degrees. In particular, it is more preferable that the inclination angle θ is in the range of 5 to 15 degrees. In this 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 pressure force applied by the pressure portion 6a is distributed more radially inward than in the axial direction, so that the joining block 4 can be appropriately deformed in the radial direction without applying excessive axial clamping pressure. In this third step, the pressure member 6 is moved toward one side in the axial direction, and as shown in Figure 5, the pressure portion 6a deforms the other end edge 4c of the pipe outer coating portion 4b obliquely inward over the entire circumference.

As described above, as shown by the dotted line in FIG. 5, when the edge 4c is deformed obliquely inward over the entire circumference by the pressure applied by the pressure unit 6b, the inner corner 4i of the edge 4c bites into the outer circumferential surface 3a of the flexible tube 3, causing the flexible tube 3 to locally deform radially inward into an annular shape over the entire circumference, and a part 3e of the inner circumferential surface 3d inside the deformed area 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 tube coating part 4b is plastically deformed obliquely inward by the pressure unit 6a, but the amount of deformation radially inward can be increased or decreased depending on the increase or decrease in the thickness of the outer tube coating part 4b (the step amount of the edge 4c on the outer circumferential surface 3a of the flexible tube 3, which is a tubular material). In addition, the above-mentioned amount of deformation and its axial deformation range can be increased or decreased depending on the increase or decrease in the amount of movement of the pressure unit 6a to one side in the axial direction.

At this time, the axial position Pi of the edge 4c, more preferably the inner corner 4i, is located inside the axial formation region 2e of the annular groove 2c of the needle tube 2. Also, inside the formation region 2e, the axial position Pi of the edge 4c or the inner corner 4i is separated from the axial positions of both the axial side edges 2c1 and 2c2 of the annular groove 2c, and is spaced from both of these positions. In this way, the penetration of the inner corner 4i into the outer peripheral surface 3a described later facilitates the penetration of a part 3e of the inner peripheral surface 3d of the flexible tube 3 into the annular groove 2c, making it easier for the part 3e to penetrate into the annular groove 2c. Also, 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 J can be improved.

In the illustrated example, as shown in Figures 3 and 6, the cross-sectional shape of the annular groove 2c is rectangular, and both side edges on either side of the axial direction are surfaces along the radial direction and perpendicular to the axial direction. Such a cross-sectional shape of the annular groove 2c helps to increase the axial joining strength of the joint J. In addition, such a cross-sectional shape of the groove also has the advantage of making it easier to process.

However, in order to further increase the degree of engagement with the inner peripheral surface 3d of the flexible tube 3 and to have a portion 3e of the inner peripheral surface 3d strongly engage with the annular groove 2c in the axial direction to increase the tensile strength of the joint J, it is preferable to gently incline the side edge 2c1 of the annular groove 2c on one side of the axial direction, to reduce the angle between the side edge 2c1 and the axial direction, and to steeply incline the side edge 2c2 of the annular groove 2c on the other side of the axial direction, to increase the angle between the side edge 2c2 and the axial direction, as shown in the enlarged view in the upper right of Figure 3. This is because the gentle inclination of the side edge 2c1 makes it easier for the portion 3e to enter the inside of the annular groove 2c, and the steep inclination of the side edge 2c2 increases the degree of engagement between the portion 3e and the annular groove 2c, and in particular, the strength of preventing the flexible tube 3 from slipping out of the needle tube 2 or the joint block 4 to the other side in the axial direction is increased.

The base end (intratubular placement portion) 2b of the needle tube 2, its annular groove 2c, the flexible tube 3, and the edge 4c of the outer tube coating portion 4b are most preferably configured to have a concentric shape (perfect ring, cylindrical or conical surface) centered on the axis Jx, as in the illustrated example. However, if the above-mentioned components are configured to exist around the entire circumference of the axis Jx and to have a closed shape, the airtightness (airtightness) around the axis Jx can be ensured and the tensile strength in the axial direction can be increased. However, if there are discontinuous steps or folds around the axis Jx, the above-mentioned airtightness and tensile strength will also decrease, so the joining structure of the above-mentioned components does not have to be a shape that follows a perfect circle around the axis, but rather it can be a circular shape with a continuous curved outline without discontinuities or inflection points (without unevenness), such as an ellipse or oval, i.e., a cylindrical or conical shape.

According to this embodiment, it is possible to realize a structure of the joint J having good adhesion, high joint strength, and high stability between the needle tube 2 and the flexible tube 3 without heating or gluing. In particular, the edge 4c on the other side opposite to the one side of the outer tube coating part 4b is plastically deformed in an annular shape diagonally inwardly over the entire circumference toward the one side, so that the edge 4c on the other side is annularly embedded into the outer peripheral surface 3a of the flexible tube 3, which is a tubular material, and a part 3e of the inner peripheral surface 3d of the other side is embedded inside the annular groove 2c. This makes it possible to avoid insufficient or reduced airtightness between the needle tube 2 and the flexible tube 3, which may cause liquid leakage. In addition, when the above-mentioned plastic deformation occurs, the abutment surface 4p of the tube end abutment portion 4a of the joining block 4 fixed to the needle tube 2 abuts against the open end 3c of the flexible tube 3 in the axial direction and supports the flexible tube 3 from one side, so that the other end edge 4c of the tube outer covering portion 4b can be easily plastically deformed diagonally inward toward the one side, and can be processed accurately and reliably. Furthermore, even when joining a tubular material made of a resin material such as the flexible tube 3, the tensile strength of the joint J in the axial direction can be ensured, and the durability of the joint J can also be increased.

In this embodiment, unlike the usual crimping process that narrows from the outside in the radial direction to the inside, the edge 4c on the other side of the axial direction of the outer tube coating part 4b is plastically deformed diagonally inward to one side in the axial direction. Since the edge 4c is deformed instead of the cylindrical part of the outer tube coating part 4b, plastic deformation is easier, and as a result, there is an advantage that it is possible to deform evenly around the entire circumference. In addition, since the crimping direction is diagonally inward to one side instead of radially inward, there is less resistance to deformation and it is easier to increase the amount of deformation, so it is easier to ensure the amount of penetration into the flexible tube 3 and the amount of penetration of a part 3e of the flexible tube 3 into the annular groove 2c, making it easier to obtain a reliable joint state. Note that these points are the same in other embodiments described later.

Next, a medical device according to a second embodiment of the present invention will be described with reference to Figures 7 and 8. In this second embodiment, the tube end abutment portion 14a and the tube outer covering portion 14b, which correspond to the joining block 4 in the first embodiment, are constructed separately. However, the needle tube 12 and the flexible tube 13 other than the above can be constructed in the same manner as the needle tube 2 and the flexible tube 3 in the first embodiment.

7, a step structure 14j is formed on the outer periphery of the initial tube end abutment portion 14a on the other side in the axial direction, that is, on the outer periphery of the abutment surface 14p with which the open end 13c of the flexible tube 13 abuts. This step structure 14j has a step surface 14jx formed between the tube end abutment portion 14a and a part on one side of the outer periphery, and a support surface 14jy located below the step of this step surface 14jx. One end 14k of the tube outer coating portion 14b engages with this step structure 14j. The end surface 14kx of this end 14k abuts against the step surface 14jx in the axial direction. The end 14k is supported in the radial direction by the support surface 14jy. In the illustrated example, the radial step amount of the step structure 14j and the thickness of the tube outer coating portion 14b almost correspond to each other, but they do not necessarily have to be the same. However, it is preferable that the thickness of the outer tube covering part 14b 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 edge of the end 14k of the outer tube covering part 14b does not protrude from the outer peripheral surface of the tube end abutment part 14a, and this reduces problems such as the end 14k of the outer tube covering part 14b coming off the tube end abutment part 14a due to something hitting the edge of the end 14k, causing the joint to loosen.

Figure 8 shows the state of joining the needle tube 12 and the flexible tube 13. As in the first embodiment, a pressure member is applied to one end surface 14e of the tube end abutment 14a to form a recess 14f, and the tube end abutment 14a is fixed to the needle tube 12 by inserting a part 14g of its inner surface 14d into the fitting groove 2d through compositional deformation of the tube end abutment 14a. In this state, the same joining operation as in the first embodiment is performed to plastically deform the other end edge 14c of the tube outer covering 14b diagonally inward to one side over the entire circumference. Due to the compositional deformation of this end edge 14c, the inner corner 14i of the end edge 14c bites into the outer surface 13a of the flexible tube 13 over the entire circumference, and as a result, a part 13e of the inner surface 13d of the flexible tube 13 enters the annular groove 12c of the needle tube 12 over the entire circumference.

In this embodiment, the tube end abutment portion 14a and the tube outer covering portion 14b are provided as separate bodies, and are engaged in the radial direction while abutting in the axial direction by the step structure 14j, so that the tube outer covering portion 14b can be attached at an appropriate timing during manufacturing, and the joining work can be facilitated. For example, initially, only the tube end abutment portion 14a can be attached to the needle tube 2 to perform the joining work, and then the tip portion 13b of the flexible tube 13 can be inserted into the base end portion 12b of the needle tube 12, and then the tube outer covering portion 14b can be fitted on the outside. In addition, by making the tube end abutment portion 14a and the tube outer covering portion 14b separate, it is possible to make them from different materials. For example, by making the tube end abutment portion 14a from a resin material and the tube outer covering portion 14b from a metal material, it is also possible to fix the tube end abutment portion 14a and the needle tube 12 by a method other than plastic flow, such as a bonding method using an adhesive. This means that the optimal fixing method can be adopted depending on the relationship between the materials of the tube end abutment portion 14a and the needle tube 12 (portion placed inside the tube), which makes it possible to expand the options and adaptability for the configurations to be joined together.

In this embodiment, the outer peripheral corner 14h on one side of the axial direction of the tube end abutment portion 14a can be rounded or chamfered to enable smooth insertion into the body. In this embodiment, as in the first embodiment, it is also effective to configure the cross-sectional shape of the annular groove 2c as shown in the upper right of Figure 3. Furthermore, in this embodiment, as in the first embodiment, the inclination angle θ of the conical surface 6b of the pressure portion 6a with respect to the axial direction can be set within the aforementioned range to obtain the same effect.

Next, a medical device according to a third embodiment of the present invention will be described with reference to Figures 9 to 12. In this third embodiment, as shown in Figure 9, a closure member 24 is attached to the open end 23c of the tip 23b of the flexible tube 23, thereby closing the tip 23b on one axial side of the flexible tube 23. The closure member 24 has a tube end abutment 24a and an in-tube placement portion 24m that is integrally configured (fixed) to the tube end abutment 24a. Here, the closure member 24 may be integrally provided with an outer tube covering portion 24b, but in the illustrated example, the outer tube covering portion 24b is configured separately from the closure member 24. In this embodiment, the outer tube covering portion 24b abuts against the step surface of the abutment surface 24p between the tube end abutment portion 24a and the in-tube placement portion 24m of the closure member 24 in the axial direction. As with the step structure 14j of the second embodiment, a step structure 24j (shown as dotted lines) with which one end 24k of the outer tube covering part 24b is to engage may be formed in addition to the contact surface 24p with which the open end 23c of the flexible tube 23 contacts. An annular groove 24n is formed on the outer circumferential surface of the inner tube placement part 24m.

In this embodiment, the pipe end abutment portion 24a having the abutment surface 24p and the pipe internal placement portion 24m are integrally formed, so the second step for fixing them to each other is not necessary. In the first step, the flexible tube 23 and the pipe external covering portion 24b are inserted into the closing member 24, and then the third step is performed. In the third step, as in the first embodiment, the pressure member 26a of the pressure member 26 is used as shown in Figure 10. Then, as shown in Figure 11, the pressure member 26 is moved in the axial direction, and the conical surface 26b of the pressure member 26a abuts against the other edge 24c of the pipe external covering portion 24b, and the edge 24c is plastically deformed diagonally inward to one side over the entire circumference. Finally, the inner corner 24i of the edge 24c bites into the outer circumferential surface 23a of the flexible tube 23 over the entire circumference, and as a result, a portion 23e of the inner circumferential surface 23d of the flexible tube 23 fits into the annular groove 24n over the entire circumference.

In this embodiment, a closure member 24 having a tube end abutment 24a and an in-tube placement portion 24m and an outer tube covering portion 24b are joined to the open end 23c on one side of the flexible tube 23, and the open end 23c is closed by the structure of this joint. Therefore, due to plastic deformation of the edge 24c of the outer tube covering portion 24b diagonally inward, its inner corner 23i bites into the outer circumferential surface 23a of the flexible tube 23 over the entire circumference, and a part 23e of the inner circumferential surface 23d penetrates into the annular groove 24n of the in-tube placement portion 24m over the entire circumference, so that the open end 23c can be closed airtight.

In this embodiment, the corner 24h on the outer periphery on one side of the axial direction of the tube end abutment portion 24a is rounded or chamfered, thereby enabling smooth insertion into the body, etc. In addition, as shown in the figure, by configuring the inclination angle of the side edge on one side of the axial direction of the cross-sectional shape of the annular groove 24n to be small and the inclination angle of the side edge on the other side of the axial direction to be large, it is possible to facilitate the insertion of a portion 23e of the inner surface 23d of the flexible tube 23 into the annular groove 24n and to increase the engagement strength of the portion 23e with the annular groove 24n, thereby improving the axial tensile strength of the flexible tube 23 with respect to the connector (the closure member 24 and the tube outer covering portion 24b).

In this embodiment, as in the first embodiment, by setting the inclination angle θ of the conical surface 6b of the pressure section 6a relative to the axial direction within the aforementioned angle range, the edge 24c of the outer tube coating section 24b can be appropriately and reliably plastically deformed diagonally inward, thereby realizing a strong joint J structure. Note that each of the above-mentioned embodiments can be appropriately modified by, for example, replacing each component with another, as long as there are no mutual contradictions or infeasibility circumstances.

The joint structure of the medical member and the catheter of the present invention are not limited to the above-mentioned illustrated examples, and various modifications can be made without departing from the scope of the present invention. For example, in each of the above-mentioned embodiments, the tubular material is assumed to be a flexible tube 3, 13, 23, and the connector is assumed to be a joint block 4 or a tube end abutment portion 14a and a connecting member between the tube outer covering portion 4b and the needle tube 2, or a closing member 24 and the tube outer covering portion 24b. However, a metal tube can be used as the tubular material, and various configurations can be adopted for the connector as long as it has a tube end abutment portion, an intratubular portion, and a tube outer covering portion.

In addition, in each of the above embodiments, the thickness of the outer tube covering portion 4b, 14b, 24b is smaller than the thickness of the flexible tube 3, 13, 23, which is a tubular material, thereby reducing the protrusion of the connector from the outer peripheral surface (3a) of the tubular material, but in the present invention, this is not particularly limited and is appropriately set according to the mechanical characteristics due to the materials of the outer tube covering portion 4b, 14b, 24b and the flexible tube 3, 13, 23, which is a tubular material. . The depth and axial width of the annular groove 2c, 12c, 24n may be set according to the thickness and mechanical characteristics of the flexible tube 3, 13, 23, which is a tubular material, but generally, it is preferable to configure it deeper and wider as the thickness of the flexible tube 3, 13, 23 increases, and in this case, it is desirable to increase the thickness of the forming tube outer covering portion 4b, 14b, 24b.

DESCRIPTION OF SYMBOLS 1... Medical member (catheter), 2... Needle tube, 2a... Outer peripheral surface, 2b... Proximal end, 2c... Annular groove, 2d... Fitting groove, 2e... Axial direction formation region, 3... Resin tube, 3a... Outer periphery Surface, 3b...Tip, 3c...Opening end, 3d...Inner peripheral surface, 3e...Part, 4...Joining block, 4a...Pipe end contact portion, 4b...Pipe outer coating, 4c...Edge, 4d ...inner peripheral surface, 4e...end surface, 4f...recess, 4g...part, 4h...corner, 4i...inner corner, 4j...step structure, J...joint, Jx...axis, 5, 6, 26...machining Pressure member, 5a, 6a, 26a...pressure part, 6b, 26b...conical surface

Claims (10)

A medical device having a structure in which a tubular material and a connector connected to an open end portion on one side in an axial direction of the tubular material are joined together,
the connecting body has a tube end abutment portion that is in axial contact with the one open end of the tubular material, an in-pipe arrangement portion that is integrally formed with or fixed to the tube end abutment portion, is housed and arranged inside the tubular material, and has an annular groove at a position facing the inner circumferential surface of the tubular material, and a cylindrical outer pipe covering portion that is integrally formed with or fixed to the tube end abutment portion, or abuts at least toward the one side in the axial direction, and is attached to the outer periphery of the tubular material,
a medical device characterized in that an edge of the other side opposite the one side of the outer tubular coating portion is plastically deformed diagonally inward toward the one side over the entire circumference, such that the edge of the other side is annularly embedded into the outer peripheral surface of the tubular material and a portion of the inner peripheral surface of the tubular material extends inside the annular groove. a position in the axial direction where the edge of the outer covering portion bites into the outer circumferential surface of the tubular material is included within a region in the axial direction where the annular groove is formed in the inner-pipe portion, and is spaced apart from both side edges of the annular groove in the axial direction.
The medical device according to claim 1 . With respect to a shape of side edges on both sides in the axial direction of the annular groove, an inclination of the side edge on one side with respect to the axial direction is relatively small, and an inclination of the side edge on the other side with respect to the axial direction is relatively large.
The medical device according to claim 1 or 2. The base end portion of the other side arranged inside the tubular material corresponds to the in-tube arrangement portion, and includes a needle tube led out from inside the open end portion of the one side of the tubular material and extending to the one side.
The medical device 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 abutting portion on the one side of the annular groove, and a part of the inner peripheral surface of the tube end abutting portion is inserted into the fitting groove by plastic deformation that forms a recess on the end surface of the one side of the tube end abutting portion.
The medical device according to claim 4. the tube end abutment portion and the tube outer covering portion are configured as separate bodies, a step structure that is open toward the other side is provided on an outer circumferential portion of the tube end abutment portion, and the one end of the tube outer covering portion is engaged with the step of the step structure in a state in which the one end is disposed on a support surface below the step of the step structure, and the one end of the tube outer covering portion abuts against the step of the step structure.
The medical device according to any one of claims 1 to 5. A method for manufacturing a medical device having a structure in which a tubular member and a connector connected to an open end portion on one side in an axial direction of the tubular member are joined together, comprising:
the connecting body has a tube end abutment portion that is in axial contact with the one open end of the tubular material, an in-pipe arrangement portion that is integrally formed with or fixed to the tube end abutment portion, is housed and arranged inside the tubular material, and has an annular groove at a position facing the inner circumferential surface of the tubular material, and a cylindrical outer pipe covering portion that is integrally formed with or fixed to the tube end abutment portion, or abuts at least toward the one side in the axial direction, and is attached to the outer periphery of the tubular material,
a conical surface inclined relative to the axial direction is applied with pressure to plastically deform the edge of the other side of the outer tubular coating portion opposite the one side diagonally inward toward the one side over the entire circumference, so that the edge of the other side annularly bites into the outer peripheral surface of the tubular material and a portion of the inner peripheral surface of the tubular material fits inside the annular groove. a position in the axial direction where the edge of the outer covering portion bites into the outer circumferential surface of the tubular material is included within a region in the axial direction where the annular groove is formed in the inner-pipe portion, and is spaced apart from both side edges of the annular groove in the axial direction.
The method for producing a medical device according to claim 7. With respect to a shape of side edges on both sides in the axial direction of the annular groove, an inclination of the side edge on one side with respect to the axial direction is relatively small, and an inclination of the side edge on the other side with respect to the axial direction is relatively large.
The method for producing a medical device according to claim 7 or 8.
The inclination angle of the conical surface with respect to the axial direction is within a range of 3 to 30 degrees.
The method for producing a medical device according to any one of claims 7 to 9.

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