JP2015058299A - Treatment member for treating living body, treatment instrument and manufacturing method of treatment member for treating living body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a treatment member for treating living body, a treatment instrument and a manufacturing method of the treatment member for treating living body capable of reliably connecting members constituting the treatment instrument, and suppressing deterioration of slidability to a sheath.SOLUTION: A treatment member for treating living body comprises: a first member made of a superelastic alloy and having a functional part for treating a living body and a base part connected to one end of the functional part; a second member formed by using a different material from the first member and having a diameter which can butt at least a diameter of an outer periphery of the side connected with the base part; a cover member, which forms a sleeve shape having the substantially same inner diameter as the diameter of the outer periphery of the connection portion of the first and second members, for covering the connection part; and a fixing member for covering the cover member and fixing a position of the cover member to the connection part.

Description

  The present invention is provided in an endoscope for observing a tissue of a specimen using, for example, an ultrasonic wave, and is a bioprocessing treatment for biopuncture that is punctured into a body tissue of a specimen to inject a drug or extract a tissue. The present invention relates to a member, a treatment tool having the treatment member, and a method of manufacturing the treatment member.

  Conventionally, in a tissue diagnosis for diagnosing a tissue in a subject using an endoscope that observes the tissue using ultrasonic waves, a treatment tool for treating a region of interest of the subject, for example, a puncture needle that punctures the region of interest Is used. In this tissue diagnosis, while inserting an endoscope into a subject and observing the tissue of the subject using ultrasonic waves, the puncture needle is inserted through the endoscope and the puncture needle is punctured into a site of interest. A drug is injected into a region of interest through a puncture needle or a tissue is collected.

  Further, the puncture needle is required to have flexibility when puncturing the site of interest and shape reproducibility before and after puncture. Superelastic alloys with superelasticity, such as nickel-titanium alloys, have the flexibility and shape reproducibility described above, are less prone to plastic deformation, and have excellent insertability into the region of interest when applied to a puncture needle. Can be. For this reason, recent puncture needles have been made using superelastic alloys such as nickel-titanium alloys.

  The superelastic alloy described above has a higher material cost than other metals and alloys, and as a result, increases the manufacturing cost of the puncture needle. For this reason, there has been a demand for an alternative technique that satisfies the flexibility and shape reproducibility of the puncture needle and can reduce the manufacturing cost.

  As an alternative technique, a cylindrical shape having a sharp tip shape is formed, and a connecting portion between a needle-like body made of a superelastic alloy and a tubular portion having a diameter equivalent to that of the needle-like body is covered with a sleeve. A fixed puncture needle (surgical needle) is disclosed (see, for example, Patent Document 1).

  FIG. 10 is a partial cross-sectional view showing an example of a configuration of a main part of a conventional puncture needle. The puncture needle disclosed in Patent Document 1 is made of a superelastic alloy like a puncture needle 300 shown in FIG. 10, and a needle-like body 301 having a substantially cylindrical shape with a sharp tip at one end, and the needle-like body 301. A connecting portion between the needle-like body 301 and the tubular portion 302 in a state where the tubular portion 302 having a diameter equivalent to that of the needle-shaped body 301 and the needle-like body 301 and the tubular portion 302 are abutted so that the hollow spaces thereof communicate with each other And a sleeve 303 for covering. At this time, by using a material having a lower material cost than the superelastic alloy for the tubular portion 302, at least the flexibility and shape reproducibility at the distal end portion of the puncture needle 300 are satisfied and the manufacturing cost is suppressed. Can do.

  The puncture needle 300 is accommodated in the treatment instrument by a sheath 310 that accommodates the puncture needle 300 so as to be able to advance and retreat. The puncture needle 300 can adjust the exposure amount of the needle-shaped body 301 to the outside of the sheath 310 by moving inside the sheath 310.

Japanese Patent No. 4982637

  Here, when the puncture needle 300 moves inside the sheath 310, the inner wall surface 311 of the sheath 310 contacts the sleeve 303, and friction occurs between the sleeve 303 and the inner wall surface 311 as the puncture needle 300 moves. The slidability of the puncture needle 300 with respect to the sheath 310 may be reduced.

  The present invention has been made in view of the above, and is a treatment member and treatment tool for living body treatment that can reliably connect members constituting the treatment tool and suppress a decrease in slidability with respect to the sheath. And it aims at providing the manufacturing method of the treatment member for biological treatment.

  In order to solve the above-mentioned problems and achieve the object, a treatment member for biological treatment according to the present invention is composed of a superelastic alloy having a functional part for treating a biological body and a base part connected to one end of the functional part. A first member formed of a material different from that of the first member, and a second member having a diameter at least capable of abutting with the base portion on a side connected to the base portion, and the first and first members. A sleeve having an inner diameter substantially the same as the outer diameter of the connecting portion of the two members, a covering member that covers the connecting portion, and a fixing that covers the covering member and fixes the position of the covering member with respect to the connecting portion. And a member.

  The treatment member for biological treatment according to the present invention is characterized in that, in the above invention, the fixing member has a substantially cylindrical shape, is made of a material that contracts by heat, and covers the entire outer surface of the covering member. And

  A treatment instrument according to the present invention includes the treatment member according to the above-described invention, a sheath capable of accommodating the treatment member so as to be able to advance and retreat, and an operation unit that operates an advance / retreat operation of the treatment member in the sheath. It is characterized by that.

  Also, the method for manufacturing a treatment member for biological treatment according to the present invention is the above-described invention, wherein the first member is made of a superelastic alloy having a functional part for treating a living body and a base part connected to one end of the functional part. And the end of the second member, which is formed using a material different from that of the first member and has an outer diameter at least on the side connected to the base, the diameter of which can be abutted with the base. Inserting the first and second members abutted by the step and the abutting step into a sleeve-shaped covering member having an inner diameter substantially the same as the outer diameter of the connecting portion of the first and second members; An insertion step of disposing the covering member on the connecting portion, and a fixing member having a substantially cylindrical shape and having an inner diameter smaller than an outer diameter of the connecting portion due to contraction due to heat, A covering step for covering the region where, is deflated by heating the fixing member, characterized by comprising a fixed step of fixing the position of the cover member with respect to the connecting portion.

  According to the present invention, it is possible to reliably connect the members constituting the puncture needle and to suppress the decrease in slidability with respect to the sheath.

FIG. 1 is a diagram schematically showing a configuration of an ultrasonic observation system according to an embodiment of the present invention. FIG. 2 is a diagram schematically showing the configuration of the distal end portion of the insertion portion of the ultrasonic endoscope shown in FIG. FIG. 3 is a diagram schematically illustrating a configuration example of the treatment instrument of the ultrasonic observation system illustrated in FIG. 1. FIG. 4 is a diagram schematically showing a configuration of a main part of the processing tool of the ultrasonic observation system shown in FIG. FIG. 5 is a partial cross-sectional view showing a configuration of a main part of the treatment instrument of the ultrasonic observation system shown in FIG. FIG. 6 is a diagram schematically illustrating a configuration example of a syringe used in the ultrasonic observation system illustrated in FIG. 1. FIG. 7 is a diagram for explaining a method of manufacturing a puncture needle according to an embodiment of the present invention. FIG. 8 is a diagram for explaining a method of manufacturing a puncture needle according to an embodiment of the present invention. FIG. 9 is a diagram for explaining a method of manufacturing a puncture needle according to an embodiment of the present invention. FIG. 10 is a partial cross-sectional view showing an example of a configuration of a main part of a conventional puncture needle.

  DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. In addition, this invention is not limited by the following embodiment. Hereinafter, in this embodiment, an ultrasonic observation system will be described as a configuration example using a treatment member and a treatment tool. The drawings referred to in the following description only schematically show the shape, size, and positional relationship so that the contents of the present invention can be understood. That is, the present invention is not limited only to the shape, size, and positional relationship illustrated in each drawing.

  FIG. 1 is a diagram schematically showing a configuration of an ultrasonic observation system according to an embodiment of the present invention. The ultrasound observation system 1 shown in the figure can be inserted into a subject and transmits a pulsed ultrasound wave, while having a function of receiving an ultrasound wave (echo) reflected externally, An ultrasonic endoscope 2 having a function of generating an image signal by imaging, and an ultrasonic wave that generates an ultrasonic image by performing predetermined processing on an electrical echo signal received from the ultrasonic endoscope 2 Realized using an observation apparatus 3, an endoscope observation apparatus 4 that generates an endoscopic image based on an image signal generated by the ultrasonic endoscope 2, and a display panel made of liquid crystal or organic EL, A display device 5 capable of displaying an image generated by the ultrasonic observation device 3 and the endoscope observation device 4, a light source device 6 for supplying illumination light emitted from the tip of the ultrasonic endoscope 2 to the outside, and an ultrasonic wave The endoscope 2 and the ultrasonic observation apparatus 3 are electrically connected An ultrasonic cable 7 to be connected electrically, a video cable 8 to electrically connect the ultrasonic endoscope 2 and the endoscope observation device 4, and an ultrasonic endoscope 2 and the light source device 6 to each other, An optical fiber cable 9 having an optical fiber for supplying illumination light generated by the light source device 6 to the ultrasonic endoscope 2 and a treatment instrument insertion port 223 to be described later are inserted into the distal end of the ultrasonic endoscope 2. And a treatment tool 10 capable of treating a living body such as releasing a drug from one end or collecting a body tissue.

  The ultrasonic endoscope 2 includes an insertion portion 21 to be inserted into the body, an operation portion 22 connected to the proximal end side of the insertion portion 21, a universal cable 23 extending from the operation portion 22, and a universal cable 23 And a connector 24 provided at the tip.

  The insertion portion 21 is connected to the ultrasonic probe 211 provided at the distal end, the ultrasonic probe 211, the hard portion 212 made of a hard member, and the base end side of the hard portion 212 so as to be bent. It has a bending portion 213 and a flexible tube portion 214 that is provided on the proximal end side of the bending portion 213 and has flexibility. Inside the insertion portion 21, a light guide that transmits illumination light and a plurality of signal lines that transmit various electrical signals are provided. Further, a treatment instrument insertion passage for inserting a part of the treatment instrument 10 is formed in the insertion portion 21.

  FIG. 2 is a diagram schematically illustrating the configuration of the distal end portion of the insertion portion 21. The ultrasonic probe 211 is a convex-type ultrasonic probe, and includes a transducer unit 215 in which a plurality of ultrasonic transducers are regularly arranged. The ultrasonic transducer has an acoustic lens, a piezoelectric element, and a matching layer, and acquires an ultrasonic signal that contributes to an ultrasonic tomographic image inside the body wall of the subject. The plurality of ultrasonic transducers are arranged so as to form a convex arc.

  A treatment instrument channel 212 a for extending various treatment instruments is formed at the distal end of the rigid portion 212. FIG. 2 shows a case where the puncture needle 102 of the treatment instrument 10 extends from the treatment instrument channel 212a. The extension angle of the puncture needle 102 from the treatment instrument channel 212 a is determined according to the type of the insertion portion 21. Note that a mechanism for adjusting the extension angle of the puncture needle 102 may be provided in the insertion portion 21.

  The ultrasonic probe 211 converts an electrical pulse signal received from the transmission / reception unit 31 into an ultrasonic pulse (acoustic pulse signal), and converts an ultrasonic echo reflected by an external specimen into an electrical echo signal. Has a function to convert. The echo signal converted by the ultrasonic probe 211 is transmitted to the ultrasonic observation apparatus 3 via the ultrasonic cable 7. Note that the scanning method of the ultrasonic transducer in the ultrasonic probe 211 is an electronic scanning method.

  An imaging element (not shown) is provided at the distal end of the rigid portion 212 to capture an image of a subject located in a predetermined visual field region and generate an image signal for an endoscopic image. An imaging signal generated by the imaging element is transmitted to the endoscope observation apparatus 4 via the video cable 8.

  Illumination light supplied from the light source device 6 can be irradiated from the distal end portion of the rigid portion 212. Specifically, an illumination window for irradiating illumination light transmitted from the light source device 6 is provided at the distal end portion of the rigid portion 212.

  The operation unit 22 includes a bending knob 221 that performs bending operation of the bending unit 213 in the up-down direction and the left-right direction, a plurality of operation members 222 for performing various operations, and a treatment instrument insertion passage formed in the insertion unit 21. It has a treatment instrument insertion port 223 for communicating and inserting the treatment instrument 10 into the treatment instrument insertion path.

  The universal cable 23 is inserted with a plurality of signal lines for transmitting electrical signals, an optical fiber for transmitting illumination light, and the like.

  The connector 24 transmits and receives signals to and from the ultrasonic observation device 3, the endoscope observation device 4, and the light source device 6 through the ultrasonic cable 7, the video cable 8, and the optical fiber cable 9.

  FIG. 3 is a diagram schematically illustrating a configuration example of the treatment instrument 10 of the ultrasonic observation system 1 illustrated in FIG. 1. FIG. 4 is a diagram schematically showing a configuration of a main part of the processing tool 10 of the ultrasonic observation system 1 shown in FIG. FIG. 5 is a partial cross-sectional view showing a configuration of a main part of the ultrasonic observation system 1 shown in FIG. The treatment instrument 10 is inserted into the treatment instrument insertion port 223 and has one end 100 that can be extended from the distal end of the ultrasonic endoscope 2 and a substantially tubular operation section 110 that operates the insertion section 100. Have The insertion portion 100 is inserted into the flexible tube portion 101 so as to be able to advance and retract, and is connected to the operation portion 110 of the flexible tube portion 101. And a puncture needle 102 (treatment member) having a needle shape that can protrude from an end on a different side. The puncture needle 102 has a flexible cylindrical shape, and one end surface is inclined with respect to the cylindrical central axis.

  The puncture needle 102 has a cylindrical portion 103a (base portion) having a cylindrical shape and a needle portion 103b (functional portion) having a sharp tip shape that is connected to one end of the cylindrical portion 103a, and is a needle made of a superelastic alloy. A tubular portion 104 (second member) connected to the other end of the cylindrical body 103 (first member) and the cylindrical portion 103a, and a connecting portion between the needle-like body 103 and the tubular portion 104 is covered. And a fixing portion 105 to be fixed. The fixing portion 105 covers the connecting portion and fixes the positional relationship between the needle-like body 103 and the tubular portion 104 so that the hollow spaces communicate with each other. In addition, the hollow portion 1040 of the tubular portion 104 communicates with the hollow portion 1030 formed in the needle-like body 103 at one end, and is connected to the operation portion 110 at the other end. The diameter of the outer periphery of the tubular portion 103a is equal to the diameter of the outer periphery of the tubular portion 104. The diameter of the hollow portion 1030 (inner circumference) of the needle-like body 103 is equal to the diameter of the hollow portion 1040 (inner circumference) of the tubular portion 104. For example, the needle-like body 103 has an outer diameter of φ1 mm and a wall thickness (a radial distance between the outer surface and the inner surface) of 0.1 mm.

  The acicular body 103 is formed using a superelastic material (superelastic alloy). A superelastic alloy is an alloy having a shape reproduction characteristic (shape memory characteristic) at a temperature equal to or higher than the transformation point, and the transformation point is equal to or lower than room temperature, such as a nickel-titanium alloy or an iron-manganese-silicon alloy. And iron-based alloys and copper-based alloys. The needle-like body 103 is given a superelasticity by being formed into a predetermined shape and then subjected to an aging effect treatment.

  The tubular portion 104 is formed using a material different from the needle-like body 103 and having a lower material cost than the superelastic alloy. The tubular portion 104 is formed using, for example, stainless steel (SUS). Accordingly, at least the bending property and shape reproducibility of the puncture needle 102 at the distal end portion (needle-like body 103) of the puncture needle 102 can be satisfied, and the manufacturing cost can be suppressed.

  The fixing portion 105 covers a connecting portion between the needle-like body 103 (tubular portion 103a) and the tubular portion 104, and fixes the positional relationship between the needle-like body 103 and the tubular portion 104, and the puncture needle 102. A fixing member 105b that covers the outer surface including the covering member 105a and fixes the connecting portion of the needle-like body 103 including the covering member 105a and the tubular portion 104.

  The covering member 105a is formed using, for example, stainless steel (SUS) and has a sleeve shape that forms a hollow space having a diameter (inner diameter) that is the same as or smaller than the outer diameter of the needle-like body 103 (tubular portion 103a). Yes. The covering member 105a has an inner diameter of the needle-like body 103 (tubular portion 103a) if the positional relationship between the needle-like body 103 and the tubular portion 104 can be fixed by an adhesive member (adhesive material such as solder or resin). Even if it is larger than the outer diameter, it is applicable.

  The fixing member 105b is a heat-shrinkable tube having a substantially cylindrical shape formed using, for example, polytetrafluoroethylene (PTFE). The fixing member 105b contracts when heated. Here, the inner diameter of the fixing member 105b in a completely contracted state is smaller than the outer diameter of the needle-like body 103 (tubular portion 103a). Thus, the fixing member 105b covers and fixes the entire outer surface of the covering member 105a that covers the connecting portion between the needle-like body 103 and the tubular portion 104, and is in close contact with the needle-like body 103 and the tubular portion 104, respectively. Therefore, the outer surface of the puncture needle 102 in the area where the covering member 105a is disposed is smoothed.

  The fixing member 105b is applicable as long as it is a material that thermally contracts at a temperature lower than the aging effect treatment temperature of the needle-like body 103 (for example, less than 400 ° C. if the aging effect treatment temperature is 400 ° C.). The fixing member 105b is set with an inner diameter after contraction, a length in the longitudinal direction (in the direction of the cylindrical central axis), a contraction ratio, and the like in consideration of the fixing strength and the joint use environment after joining.

  The operation unit 110 is connected to the connection unit 111 connected to the flexible tube unit 101, the index unit 112 provided with a memory indicating the extension position of the flexible tube unit 101 from the connection unit 111, and the puncture needle 102. The flexible tube portion 101 of the puncture needle 102 (needle portion 103b) is provided so as to cover the outer periphery of the indicator portion 112 and to be movable forward and backward in the longitudinal direction of the indicator portion 112. An adjustment part 113 that changes the protruding length from the front end of the head, a regulation member 114 that inserts the indicator part 112 into the hollow space in an annular shape and restricts the movement of the adjustment part 113, and one end of the operation part 110. And an attachment portion 115 connected to the adjustment portion 113. Further, the stylet 120 is inserted into the treatment tool 10 through a hollow space formed inside.

  The adjustment unit 113 is connected to the puncture needle 102 (tubular portion 104), and changes the protruding length of the puncture needle 102 from the tip of the flexible tube portion 101 by its own advance / retreat operation along the index portion 112. At this time, the adjustment unit 113 is an index unit corresponding to the protruding length of the puncture needle 102 from the distal end of the flexible tube unit 101 depending on the position of the end (in the first embodiment, the end on the connection unit 111 side). 112 points to the memory location.

  The restricting member 114 is formed with a screw hole penetrating from the outer periphery toward the inside, and is screwed into the fixing screw 114a. The fixing screw 114a is fixed to the indicator portion 112 by contacting the surface of the indicator portion 112. The movement of 113 is restricted.

  A stylet 120 or a syringe 130, which will be described later, is attached to the attachment portion 115 at an end portion 115a on the side different from the side continuous with the indicator portion 112.

  The stylet 120 is provided at one end of the flexible wire 120a inserted into the insertion unit 100 and the operation unit 110, and one end of the wire 120a, and operates to move the wire 120a forward and backward to the insertion unit 100 and the operation unit 110. And a rigid rod-like member 120c which is provided at the other end of the wire rod 120a and has a rod-like shape having a diameter corresponding to the diameter of the through-hole 1020 of the puncture needle 102. When the stylet 120 punctures a living body with the puncture needle 102, the rod-shaped member 120 c is disposed inside the puncture needle 102, so that a tissue inside the puncture needle 102 that is different from the collection target that is beaten by the puncture enters the inside of the puncture needle 102. It is possible to prevent this, or to discharge a body tissue different from the object to be collected that has entered the puncture needle 102, and to suppress deformation of the puncture needle 102 due to external pressure during puncture.

  In the puncture needle 102, a plurality of minute concave portions 102a having a substantially concave spherical shape form a spatially regular pattern at the distal end portion (needle-like body 103). The plurality of recesses 102a are provided to efficiently scatter the ultrasonic waves transmitted from the ultrasonic probe 211 so as to be easily depicted. The plurality of recesses 102a are formed so that the intervals between adjacent recesses 102a are all equal.

  The display device 5 displays an image based on the received ultrasonic wave (echo) by the ultrasonic observation system 1 having the above-described configuration. An operator such as a doctor punctures the body tissue while confirming the ultrasonic image displayed on the display device 5 to inject a drug or extract the tissue.

  FIG. 6 is a diagram schematically illustrating a configuration example of a syringe used in the ultrasonic observation system illustrated in FIG. 1. The syringe 130 includes an operation unit 131 for performing operations of suctioning and injecting liquid and the like, and a connecting unit 132 for connecting to the treatment instrument 10. The operation unit 131 includes a barrel 131a having a substantially cylindrical shape, and a plunger 131b that is fitted into one end of the barrel 131a and moves while sliding on the inner wall surface of the barrel 131a. Moreover, the connection part 132 has the connection part 132a connected with the edge part 115a of the treatment tool 10, and the switching part 132b which switches the open / close state between the barrel 131a and the connection part 132a. The switching unit 132b switches the open / close state by, for example, rotating a handle connected to a valve that switches the internal open / close state.

  The barrel 131a is formed with a pin 131c protruding from the inner peripheral surface. The plunger 131b is formed with a locking fin 131d that protrudes in a direction perpendicular to the longitudinal direction of the plunger 131b and can be engaged with the pin 131c. The relative position of the locking fin 131d and the pin 131c changes according to the rotation of the plunger 131b.

  The treatment instrument 10 can discharge the drug solution from the distal end (puncture needle 102) of the insertion unit 100 or collect the punctured tissue or body fluid by connecting the syringe 130. Specifically, first, before the treatment instrument 10 is connected, the inside of the barrel 131a is opened by the switching portion 132b of the syringe 130. Thereafter, the plunger 131b is pushed into the barrel 131a to release the air in the barrel 131a. After deaeration in the barrel 131a, the inside of the barrel 131a is closed by the switching unit 132b. Thereby, the inside of the barrel 131a is in a vacuum state. At this time, the plunger 131b is rotated to lock the locking fin 131d with the pin 131c, thereby restricting the movement of the plunger 131b with respect to the barrel 131a.

  On the other hand, in the treatment instrument 10, the adjustment portion 113 is abutted against the end portion 115, and the puncture needle 102 is accommodated inside the flexible tube portion 101. Thereafter, the regulating member 114 is abutted against the adjusting unit 113, the regulating member 114 is fixed by the fixing screw 114a, and the movement of the adjusting unit 113 is regulated.

  Thereafter, when the insertion portion 21 is inserted into the body and the distal end of the insertion portion 21 reaches the target site, the flexible tube portion 101 is inserted through the ultrasonic endoscope 2. At this time, the stylet 120 is inserted through the flexible tube portion 101. After the flexible tube portion 101 is exposed from the distal end of the insertion portion 21, the fixing state of the regulating member 114 is released, the adjustment portion 113 is moved, and the puncture needle 102 (needle-like body 103) is removed from the flexible tube portion 101. Expose. By exposing the puncture needle 102, the puncture needle 102 is punctured at a target site.

  When the puncture with the puncture needle 102 is completed, the surgeon removes the stylet 120 from the treatment instrument 10 and connects the connection portion 132a of the syringe 130 to the end portion 115a. After the syringe 130 is connected, the barrel 131a is opened by the switching unit 132b, and the plunger 131b is pulled to collect the tissue at the target site in the barrel 131a. At this time, if necessary, the tissue may be collected by moving the plunger 131b back and forth, or the puncture needle 102 may be inserted and removed.

  After the tissue is collected, the locking fin 131d is locked to the pin 131c to restrict the movement of the plunger 131b with respect to the barrel 131a, the inside of the barrel 131a is closed by the switching portion 132b, and the puncture needle is placed inside the flexible tube portion 101. 102 is accommodated, and the treatment instrument 10 is extracted from the ultrasonic endoscope 2. Thereafter, the locking state of the locking fin 131d and the pin 131c is released, the plunger 131b is pushed into the barrel 131a, and the tissue collected from the needle-like body 103 of the puncture needle 102 is taken out.

  In addition to the above-described tissue collection, body fluid may be collected through the puncture needle 102, or connected to the treatment instrument 10 in a state where the drug is filled in the barrel 131a and the puncture needle 102 is used. Alternatively, the drug may be injected into the target site.

  Then, the manufacturing method of the puncture needle 102 is demonstrated. 7 to 9 are views (partial cross-sectional views) for explaining the method of manufacturing the puncture needle according to the present embodiment. First, the needle-like body 103 and the tubular portion 104 that have been subjected to the aging effect treatment are brought into contact with each other's end surfaces (the other end of the tubular portion 103a and one end of the tubular portion 104), and the hollow portions 1030 and 1040 communicate with each other. (See the butting step, see FIG. 7). Thereafter, a rod 140 having an outer diameter substantially equal to the diameter of the hollow portions 1030 and 1040 is inserted into the hollow portions 1030 and 1040, whereby the needle-like body 103 and the tubular portion 104 are brought into close contact with each other. Fix the positional relationship.

  Next, it inserts in the state which faced the needle-like body 103 and the tubular part 104 with respect to the covering member 105a (insertion step, refer FIG. 8). At this time, the covering member 105 a is disposed at a connection portion between the needle-like body 103 and the tubular portion 104, and covers the connection portion to fix the positional relationship between the needle-like body 103 and the tubular portion 104. Thereafter, the fixing member 105b, which is a heat-shrinkable tube before being subjected to the heat treatment, is arranged so as to cover the arrangement region of the covering member 105a (covering step, see FIG. 9). After the fixing member 105b is disposed at a predetermined position, the surface of the fixing member 105b is uniformly heated to contract the fixing member 105b (fixing step). At this time, the temperature at which the fixing member 105b is heated is lower than the aging effect treatment temperature, for example, 340 ° C. As a result, the position of the covering member 105a arranged at the connecting portion is fixed.

  After the heat shrinking process of the fixing member 105b is completed, the rod 140 is removed from the hollow portions 1030 and 1040, so that the needle-like body 103 and the tubular portion 104 are connected in a state where the covering member 105a is covered by the fixing member 105b. A fixed puncture needle 102 can be obtained (see FIG. 5).

  According to the above-described embodiment, the positional relationship between the needle-like body 103 and the tubular portion 104 is fixed by the covering member 105a, and the outer surface of the puncture needle 102 including the covering member 105a is fixed to the fixing member 105b that is a heat-shrinkable tube. Since the outer surface of the puncture needle 102 is smoothed while fixing the needle-like body 103 and the tubular portion 104, the members constituting the puncture needle 102 are securely connected to each other. And the fall of the slidability with respect to the flexible tube part 101 can be suppressed.

  Further, as a conventional joining method, fixing of the needle-like body 103 and the tubular portion 104 by welding or brazing can be mentioned. However, joining by welding produces a weld metal having a cast structure, and may cause loss of shape reproduction characteristics due to precipitation of intermetallic compounds and the presence of inclusions due to oxides. Further, in joining by brazing, it is necessary to apply a chemical called flux to the surface of the member in order to prevent oxidation of the member to be brazed and lubricate the brazing. Here, as the flux, use of a material containing potassium hydrofluoride or lithium fluoride has a strong activity and is suitable for improving the bonding strength. However, these compounds are suitable for the environment and the human body. Since it is harmful, it is not preferable particularly for an endoscope used for a human body. In addition, when brazing in a vacuum, it is not necessary to use the above-mentioned flux, but since it is heated to about 900 ° C., the superelasticity of the needle-like body 103 may be lost.

  On the other hand, according to the present embodiment, the members can be joined at a temperature lower than the aging effect treatment temperature, and a material harmless to the human body can be used. Therefore, the harmless puncture needle 102 having super elasticity can be produced safely.

  In the embodiment described above, the fixing member 105b has been described as covering the entire outer surface of the covering member 105a. However, the position of the covering member 105a with respect to the connecting portion of the needle-like body 103 and the tubular portion 104 is described. As long as it can fix, it is applicable even if it covers a part of the outer surface. The fixing member 105b is not limited to a heat-shrinkable tube, and is formed using an elastic material and has a smaller inner diameter than the outer diameter of the needle-like body 103 in a natural state (a state in which a load other than gravity is not applied). Even if it has a shape, it is applicable.

  In the above-described embodiment, the outer diameter of the tubular portion 103a and the outer diameter of the tubular portion 104 have been described as being equivalent. However, the tubular portion 103a and the tubular portion 104 can abut each other. Any diameter may be used.

  In the above-described embodiment, a puncture needle that has a cylindrical shape and punctures a body tissue to collect a desired tissue has been described as an example of a treatment member for biological treatment. It is a treatment member for cauterizing tissue, and can be applied to a treatment member for biological treatment formed by joining an end portion of a rod-shaped first member and an end surface of a rod-shaped second member, It is also possible to apply to a treatment member for biological treatment having a functional part having a curved tip, and is a linear member for excising a body tissue, the tip being substantially C-shaped, both ends It is also possible to apply to a treatment member for biological treatment formed by joining the end portion (base portion) on the side where both ends are combined and the end surface of the rod-shaped second member of the wire rod (first member) in which both ends are combined. It is. The “linear shape” in the present invention includes a cylindrical shape and a rod shape regardless of whether or not a hollow space is formed.

  In the above-described embodiment, the ultrasonic observation system is described as being introduced into the body of the sample and observing the tissue of the sample. However, for example, the above-described treatment tool or the like is used in a CT (Computed Tomography) examination device. Combinations are also possible. Further, the treatment instrument may be configured only with a needle that penetrates and is latched through the tissue without having a hollow portion in addition to the above-described drug release and tissue sampling. In the above-described embodiment, the endoscope observation device 4 and the light source device 6 are described. However, only the ultrasonic observation without the endoscope observation device 4 and the light source device 6 is performed. Is also applicable.

  As described above, the treatment member for biological treatment, the treatment tool, and the method for manufacturing the treatment member for biological treatment according to the present invention reliably connect the members constituting the treatment tool and have slidability with respect to the sheath. It is useful for suppressing the decrease.

DESCRIPTION OF SYMBOLS 1 Ultrasonic observation system 2 Ultrasonic endoscope 3 Ultrasonic observation apparatus 4 Endoscope observation apparatus 5 Display apparatus 6 Light source apparatus 7 Ultrasonic cable 8 Video cable 9 Optical fiber cable 10 Treatment tool 11 Ultrasonic generator 12 Output adjustment Part 21, 100 Insertion part 22 Operation part 23 Universal cable 24 Connector 101, 214 Flexible tube part 102, 300 Puncture needle 102a Recess 103, 301 Needle-like body 103a Tubular part 103b Needle part 104, 302 Tubular part 105 Fixing part 105a Cover member 105b Fixing member 110, 131 Operation part 111, 132a Connection part 112 Index part 113 Adjustment part 114 Restriction member 114a Fixing screw 115 Mounting part 120 Stylet 120a Wire 120b Grasping part 120c Bar-shaped member 130 Syringe 131a Barrel 131b Ranger 131c Pin 131d Locking fin 132 Connecting portion 132b Switching portion 211 Ultrasonic probe 212 Hard portion 212a Treatment instrument channel 213 Bending portion 215 Transducer portion 221 Bending knob 222 Operating member 223 Treatment device insertion port 303 Sleeve 310 Sheath

Claims (4)

A functional part for treating a living body, and a first member made of a superelastic alloy having a base part connected to one end of the functional part;
A second member that is formed using a material different from that of the first member, and has a diameter that allows at least a diameter of an outer periphery connected to the base to be abutted against the base;
A sleeve having an inner diameter substantially the same as the outer diameter of the connecting portion of the first and second members, and a covering member that covers the connecting portion;
A fixing member that covers the covering member and fixes the position of the covering member with respect to the connecting portion;
A treatment member for biological treatment, comprising: The fixing member has a substantially cylindrical shape and is made of a material that shrinks by heat.
The treatment member for biological treatment according to claim 1, wherein the entire outer surface of the covering member is covered. The treatment member according to claim 1 or 2,
A sheath capable of retractably accommodating the treatment member;
An operation unit for operating an advance / retreat operation of the treatment member in the sheath;
A treatment instrument comprising: A functional part for treating a living body, an end part of a first member made of a superelastic alloy having a base part connected to one end of the functional part, and a material different from the first member, and at least the base part A butting step of butting the end of the second member having a diameter that allows the outer periphery of the connecting side to be butted against the base;
The first and second members abutted in the abutting step are inserted into a sleeve-shaped covering member having an inner diameter substantially the same as the outer diameter of the coupling portion of the first and second members, and the coupling portion An insertion step of disposing the covering member on
A covering step of covering the arrangement region of the covering member with a fixing member that has a substantially cylindrical shape and has an inner diameter that is smaller than the diameter of the outer periphery of the connecting portion by shrinkage due to heat;
A fixing step in which the fixing member is contracted by heating to fix the position of the covering member with respect to the connecting portion;
A method for manufacturing a treatment member for biological treatment, comprising:

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