JP2011072324A - Medical treatment instrument and method of manufacturing medical treatment instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical treatment instrument capable of suppressing degradation of performance in cauterization, coagulation, amputation, hemostasis, or the like caused by fixation of biological tissue for a long period of time, and a method of manufacturing the medical treatment instrument. <P>SOLUTION: The medical treatment instrument includes a metallic treatment part 1 for heating the living tissue, and a coating part 2 coating at least part of the outer surface of the metallic treatment part 1 with thermoplastic resin with fluororesin as a main component. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical treatment tool and a method for manufacturing a medical treatment tool.

  Conventionally, there are medical devices coated with a resin mainly composed of a fluorine-based resin. As such a medical instrument, for example, a treatment instrument using thermal energy is known in order to incise, stop and coagulate a living tissue. As a method of applying thermal energy, a high-frequency voltage is applied to a living tissue that is an object to be treated, and a current is passed through the living tissue to generate Joule heat (so-called high-frequency treatment tool). Friction heat is generated by supplying current such as AC, DC, DC, etc., or by embedding a heat-generating diode in the treatment part and heating the treatment part itself (so-called heat probe), or by applying ultrasonic vibration to the living tissue A method and a treatment tool such as a treatment tool (so-called ultrasonic treatment tool) are used.

  Such a treatment tool changes the impedance, discharge characteristics, electrical conductivity, thermal conductivity, and ultrasonic transmission characteristics of the electrode due to the biological tissue adhering to the surface of the treatment section during treatment of the biological tissue, and sharpness and coagulation performance. In addition, treatment performance such as hemostasis performance is degraded. Further, when used for a procedure using an endoscope including a rigid endoscope, there is a problem that the tissue fixed to the surface of the treatment portion becomes an obstacle to the visual field and limits the surgical field. Therefore, there has been a strong demand for a metal treatment portion that is difficult to adhere to a biological tissue on the surface. As a technique for solving such a problem, it has hitherto been known to provide a coat layer that reduces adhesion of a living tissue on the surface of an electrode body.

  For example, in Patent Document 1, an unevenness is formed on the surface of a metal electrode, a recess is filled with a low surface energy resin such as a fluororesin, and then a substantially smooth surface is formed from a metal portion having conductivity and a low surface energy resin. A metal electrode composed of a portion having insulating properties and low surface energy, and forming an unevenness on the electrode surface by various methods, and then applying a fluoropolymer to the entire surface, followed by buffing or sanding Discloses a manufacturing method in which the fluorine-based polymer is partially removed and the metal surface is partially exposed.

  According to the electrode described in this Patent Document 1, since the surface of the metal electrode is partially exposed to the outside by embedding the fluorine-based polymer by forming irregularities on the surface of the metal electrode, the electrode made of metal Agglomeration of living tissue that adheres to the surface of the electrode is reduced.

Japanese National Patent Publication No. 10-500051

  However, in the electrode described in Patent Document 1, there is a high risk of dropping because the fluorine-based polymer for preventing adherence of living tissue is only embedded in the recesses on the surface. Further, when the living tissue is solidified, the tissue contracts and enters a state where it bites or embraces the convex portion. Here, when the fluoropolymer part is concave and the metal electrode part is convex, the convex part where sticking is likely to occur is made of metal, so even if the fluoropolymer is partially arranged, sufficient sticking The prevention effect cannot be expressed.

  Moreover, in the manufacturing method of patent document 1, the process of processing a metal electrode, the process of roughening by blasting, the process of washing | cleaning, the process of performing a primer process, the process of apply | coating a fluoropolymer, the process of drying and hardening In addition, a smoothing process by buffing or the like and a very complicated and many process are required, resulting in a low-productivity manufacturing method. Further, the step of roughening with blasting or the like, or the step of smoothing with buffing or the like has a drawback that the fine shape of the electrode is likely to be broken and cannot be applied to a complicated shape.

  The present invention has been made in view of the above-described circumstances, and is a medical treatment instrument and medical treatment capable of suppressing deterioration of performance such as cauterization, coagulation, cutting, and hemostasis due to fixation of a living tissue over a long period of time. It aims at providing the manufacturing method of a tool.

In order to solve the above problems, the present invention proposes the following means.
The medical treatment tool of the present invention is a medical treatment tool for performing a surgical treatment on a living tissue, and at least a part of the treatment portion that comes into contact with the living tissue has a heat mainly composed of a fluororesin. A covering portion covered with a plastic resin is provided.
In this case, since at least a part of the treatment portion that comes into contact with the living tissue is covered with the thermoplastic resin whose main component is a fluororesin, the living tissue is hardly fixed.

In the medical treatment tool of the present invention, it is preferable that the covering portion is disposed in a region in the range of 1% to 50% of the outer surface of the treatment portion.
In this case, the thermoplastic resin can balance the thermal conductivity on the outer surface of the treatment portion and the suppression of adherence of living tissue. For example, in the case of less than 1%, the area of the exposed metal portion becomes too large, so that a sufficient sticking suppression effect is not exhibited. On the other hand, if it exceeds 50 percent, there arises a problem that characteristics necessary for treatment such as conductivity, thermal conductivity, and ultrasonic transmission rate are lost.

Moreover, it is preferable that the medical treatment tool of this invention is arrange | positioned so that the surface of the said coating | cover part may bulge outward in the range of 0.005 mm-0.2 mm from the outer surface of the said treatment part.
In this case, since the surface of the covering portion mainly composed of fluororesin bulges from the outer surface of the treatment portion, the living tissue is pressed relatively strongly against the surface of the covering portion, while the living tissue is the treatment portion. It is relatively weakly pressed against the outer surface of. As a result, the adherence of the living tissue to the treatment portion is suppressed.

  In the medical treatment instrument of the present invention, the thermoplastic resin is preferably a thermoplastic fluororesin having a hydroxyl group.

  In the medical treatment tool of the present invention, it is preferable that the covering portion is arranged in a line shape, a dot shape, or a lattice shape on the outer surface of the treatment portion.

  In the medical treatment instrument of the present invention, it is preferable that the treatment portion has electrical conductivity.

  In the medical treatment tool of the present invention, it is preferable that the treatment portion is capable of ultrasonic vibration.

  In the medical treatment instrument of the present invention, it is preferable that the treatment portion is made of stainless steel, titanium, a titanium alloy, or metal glass.

  The method for manufacturing a medical treatment tool of the present invention is a method for manufacturing a medical treatment tool for performing a surgical treatment on a living tissue, wherein a hydroxyl group is formed on at least a part of the outer surface of the treatment portion that contacts the living tissue. An arranging step of arranging a thermoplastic resin containing a fluorine compound, a pressure-bonding step of pressing the thermoplastic resin against the treatment portion while pressing the thermoplastic resin, and the thermoplastic resin being pressed against the treatment portion. A cooling step of cooling the thermoplastic resin and the treatment portion in a state where

  Moreover, the manufacturing method of the medical treatment tool of this invention WHEREIN: The said crimping | compression-bonding process makes the said thermoplastic resin the said treatment part at the temperature, the pressure, and the time of the range of 320 to 360 degreeC, 1-4 MPa, and 1 to 30 minutes. It is preferable to crimp.

  In the method for manufacturing a medical treatment instrument according to the present invention, it is preferable that the cooling step maintains the pressure until the temperature of the treatment portion to which the thermoplastic resin is bonded is less than 305 ° C.

  According to the medical treatment tool and the manufacturing method of the medical treatment tool according to the present invention, the treatment part that is contacted with the heated biological tissue is partially covered with the thermoplastic resin, so that cauterization due to the fixation of the biological tissue, Deterioration of performance such as coagulation, cutting, and hemostasis can be suppressed over a long period of time.

It is a perspective view which shows the medical treatment tool of one Embodiment of this invention. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the medical treatment tool of Example 2 of this invention. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the medical treatment tool of Example 3 of this invention. It is a figure which shows the manufacturing method of the medical treatment tool. It is a figure which shows the medical treatment tool of Example 4 of this invention. It is a figure which shows the medical treatment tool of Example 5 of this invention. It is a figure which shows the medical treatment tool of Example 6 of this invention. It is a figure which shows the medical treatment tool of Example 7 of this invention.

  Hereinafter, a medical treatment tool according to an embodiment of the present invention will be described with reference to FIG.

FIG. 1 is a perspective view showing a covering structure of a treatment portion 1 of a treatment tool 10 (medical treatment tool) of the present embodiment. In this embodiment, the treatment part 1 and the coating | coated part 2 provided in the outer surface of the treatment part 1 are provided.
The treatment section 1 is preferably made of a material having electrical conductivity, and stainless steel, titanium steel, titanium alloy, or the like can be adopted as such a material.

  The covering portion 2 is made of a thermoplastic resin having thermoplasticity, and for example, a resin whose main component is a fluororesin can be adopted. Moreover, when employ | adopting a fluororesin for the coating | coated part 2, it is preferable to employ | adopt the thermoplastic fluororesin which has a hydroxyl group with high adhesiveness to other materials, such as a metal.

  The covering portion 2 is formed by joining a thermoplastic resin to the treatment portion 1 by thermocompression bonding. The covering portion 2 is preferably disposed so as to partially cover the outer surface of the treatment portion 1 with a predetermined gap from the treatment portion 1. The covering portion 2 is preferably arranged so as to cover a region in the range of 1% to 50% of the outer surface of the treatment portion 1, and further in the range of 5% to 30% of the outer surface of the treatment portion 1. More preferably, the area is covered.

Below, the coating method of the treatment part 1 of the treatment tool 10 of this embodiment is demonstrated.
First, as shown in FIG. 2, a treatment section 1 is prepared. Subsequently, as shown in FIG. 3, a thermoplastic resin 2a punched in a disk shape is prepared, and the thermoplastic resin 2a is arranged on the outer surface of the treatment section 1 at predetermined intervals (arrangement step S1).

  Subsequently, as shown in FIG. 4, a heating press mold 3 (corresponding to the outer surface shape of the treatment section 1 (in this embodiment, a stainless steel plate on which polyimide is stuck so that the resin is not pressure-bonded)) is provided. The treatment portion 1 on which the thermoplastic resin 2a is disposed is brought into contact with the treatment portion 1 and is heat-pressed while being pressed against the treatment portion 1 (crimping step S2). More specifically, in the crimping step, the thermoplastic resin 2a is pressed against the treatment portion 1 with a suitable pressure, and the thermoplastic resin 2a melts beyond its melting point at the contact surface between the thermoplastic resin 2a and the treatment portion 1. This is performed by heating to a temperature at which the thermoplastic resin 2a is pressed, and by continuing pressing and heating for a predetermined time sufficient for the thermoplastic resin 2a to be suitably bonded to the surface of the treatment portion 1.

  Thereafter, in a state where the thermoplastic resin 2a is pressed against the treatment portion 1, the heating press mold 3 is cooled to cool the thermoplastic resin 2a and the treatment portion 1 (cooling step S3). The cooling step is preferably performed after the pressure bonding step, until the temperature of the thermoplastic resin 2a and the treatment portion 1 is lowered and the molten thermoplastic resin 2a is solidified. More preferably, cooling is performed until the thermoplastic resin 2a reaches normal temperature (about 25 ° C.). The cooling step may be configured to be rapidly cooled by liquid cooling, but is preferably gradually cooled by air cooling or the like.

  Finally, the treatment section 1 to which the thermoplastic resin 2a is pressure-bonded is taken out from the hot press mold 3 to complete the coating. At this time, as shown in FIG. 5, the thermoplastic resin 2 a is pressure-bonded to the treatment portion 1 to become a covering portion 2 that partially covers the outer surface of the treatment portion 1.

  Thus, the treatment tool 10 in which the treatment portion 1 is partially covered by the covering portion 2 made of the thermoplastic resin 2a is used while the treatment portion 1 is in contact with a living tissue. At this time, the surface of the covering portion 2 bulging outward from the outer surface of the treatment portion 1 is relatively strongly pressed against the living tissue, and the outer surface of the treatment portion 1 is in contact with the living tissue, but its pressing force. Is relatively weaker than that of the cover 2.

  Subsequently, the living tissue is heated by the treatment unit 1 in this state. Then, since the protein is denatured in the living tissue, the portion of the living tissue in contact with the treatment section 1 is coagulated. Since the covering portion 2 is made of a thermoplastic fluororesin mainly composed of a fluorine compound, there is little friction generated between the covering portion 2 and the living tissue, and the solidified living tissue is suppressed from remaining in the covering portion 2. ing.

  As described above, according to the treatment instrument 10 in which the treatment portion 1 is partially covered by the covering portion 2 of the present embodiment, the solidified living tissue is suppressed from remaining in the covering portion 2 and thus solidified. It is suppressed that the living tissue becomes burnt. As a result, deterioration in performance such as cauterization, coagulation, cutting, and hemostasis due to fixation of the living tissue can be suppressed over a long period of time.

  Further, since the covering portion 2 joins the thermoplastic resin 2a to the treatment portion 1 by thermocompression bonding, the covering portion 2 is prevented from dropping or peeling off from the treatment portion 1. As a result, deterioration in performance such as cauterization, coagulation, cutting, and hemostasis due to fixation of the living tissue can be suppressed over a long period of time.

  Hereinafter, the medical treatment tool of the present invention will be described in more detail with reference to examples.

Example 1
In this embodiment, referring to FIG. 1 to FIG. 5, an electric knife (high frequency knife) for performing a surgical procedure is prepared as a treatment tool, and thermoplasticity is applied to a metal treatment portion at the tip of the electric knife. An example of forming a covering portion made of resin will be described.

  In this embodiment, SUS304 stainless steel is used for the metal treatment portion 11 of the treatment tool 10 (medical treatment tool), and Silky Bond (registered trademark) manufactured by JUNKOSHA, which is a fluoropolymer adhesive film, is used for the thermoplastic resin 2a. It was adopted. A disk-shaped resin member 12a in which this Silky Bond (registered trademark) was punched out to a thickness of 30 μm and a diameter of 0.5 mm was formed.

  The disk-shaped resin members 12a are arranged in a staggered manner on the outer surface of the metal treatment portion 11 (arrangement step S1). At this time, it is preferable that the disk-shaped resin member 12a is disposed on a surface that can contact an object such as a biological tissue.

  Subsequently, the metal treatment part 11 was sandwiched between the hot press molds 3 fitted to the outer surface of the metal treatment part 11, and heated and crimped at 2 MPa and 340 ° C. for 20 minutes (crimping step S2). Thereafter, until the temperature became less than 250 ° C., the metal treatment part 11 was sandwiched between the hot press molds 3 and left at the atmospheric temperature to perform air cooling (cooling step S3).

As a result, a covering portion 12 made of the thermoplastic resin 2a having a height of 15 μm and a diameter of 0.7 mm was formed on the surface of the metal treatment portion 11 taken out from the heating press die 3.
In this example, three types of covering parts 12 were produced, ie, about 10, about 80, and about 160. At this time, the area of the metal treatment part 11 is 5 mm × 25 mm = 125 mm ² (single side), while the formed covering part 12 has an area of 0.385 mm ² , and the total area of the covering part 12 is one side. 10 is 3.85 mm ² , about 80 is 30.8 mm ² , and about 160 is 61.6 mm ² , and the area ratio of the covering portion to the metal treatment portion is about 10% and about 24, respectively. 6%, about 50%.

  For each of the metallic treatment portion (Comparative Example 1) not covered with the thermoplastic resin 2a and the metallic treatment portion 11 partially covered with the covering portion 12 of the present embodiment, the living tissue is subjected to high frequency. The solidified state of the living tissue to the outer surface of the treatment portion when coagulated by was compared. ICC200 manufactured by ERBE was used as the high-frequency power source, and the treatment part was brought into contact with the living tissue in the SOFT coagulation mode and 80 W, and the energization was repeated for about 5 seconds. As a target biological tissue, a pig liver cut out was used.

  Under the above-mentioned conditions, when the tissue coagulation was performed using Comparative Example 1 and Example 1, in Comparative Example 1, the tissue solidified on the surface of the metal treatment portion 11 by the third energization adhered firmly to almost the entire surface. When it was peeled off forcibly, the burnt tissue adhered to the surface of the metal treatment section 11, and further treatment could not be continued. Moreover, even if it tried to wipe off the fixed tissue, it was firmly fixed and could not be removed easily.

  On the other hand, in Example 1, tissue adhesion was slightly observed after about 30th energization, but it was at a level that did not hinder the continuation of treatment, and the adhered tissue could be easily wiped off. It was. That is, the treatment performance is deteriorated by forming the covering portion 12 on the surface of the metal treatment portion 11 with the disk-shaped resin member 12a made of silky bond (registered trademark) which is a thermoplastic fluororesin having a hydroxyl group. No treatment tool 10 could be obtained.

(Example 2)
Hereinafter, another embodiment of the present invention will be described in detail with reference to FIGS. As shown in FIG. 6, in this embodiment, the metal treatment portion 21 of the treatment instrument 20 employs the same SUS304 stainless steel as the metal treatment portion 11 of the first embodiment, and has a hydroxyl group as the thermoplastic resin 2a. Silky Bond (registered trademark) manufactured by Junkosha Co., Ltd., which is a thermoplastic fluororesin, was employed, and this was cut into a strip shape having a film thickness of 60 μm and a width of 0.5 mm to form a resin member 22a.

  First, as shown in FIGS. 7 to 9, the belt-shaped resin member 22a was spirally wound around the metal treatment portion 21 (arrangement step S1). Subsequently, as shown in FIG. 10, the metal treatment portion 21 was sandwiched by the hot press mold 23 fitted to the outer surface of the metal treatment portion 21 as in Example 1. A sheet containing polyimide is attached to the mold surface of the heat press mold 23 of the present embodiment to prevent the Silky Bond (registered trademark) from being thermocompression bonded to the heat press mold 23. is doing. In addition, a cooling pipe line is arranged in the heating press mold 23 of the present embodiment so that liquid cooling is possible.

  The metal treatment part 21 was heated and pressure-bonded for 15 minutes at 2.5 MPa and 345 ° C. in this hot-press mold 23 (pressure bonding step S2). Thereafter, the hot press mold 23 was cooled to room temperature (about 25 ° C.) by flowing water through the pipeline while maintaining the pressurization by the hot press mold 23 (cooling step S3).

As a result, as shown in FIG. 11, the surface of the metal treatment portion 21 taken out from the heating press die 23 is covered with a spiral silky bond (registered trademark) having a height of 30 μm and a width of 0.7 mm. 22 was formed.
Also in the present embodiment, when the living tissue is coagulated by high frequency with respect to the metal treatment portion 21 having the covering portion 22 and the metal treatment portion of Comparative Example 1 described above, the outer surface of the metal treatment portion is applied. Comparison of the state of adherence of living tissue was performed. As a result, in the same manner as in Example 1, the metal treatment part 21 having the covering part 22 of Example 2 can reduce the adherence of the living tissue and can wipe off the adhered tissue easily.

(Example 3)
Hereinafter, still another embodiment of the present invention will be described in detail with reference to FIGS. The treatment tool 30 shown in the present embodiment is a knife mainly used for cutting tissue, and in particular, used as an endoscope treatment tool that is inserted into a treatment channel of an endoscope and performs treatment inside the body. It is As shown in FIG. 12, this treatment tool 30 employs SUS403 stainless steel for a wire-shaped metal treatment portion 31 having a diameter of 0.4 mm and a length of 15 mm provided at the tip, and as a thermoplastic resin 2a. Silky Bond (registered trademark) manufactured by Junko Co., Ltd., which is a thermoplastic fluororesin having a hydroxyl group, was employed, and this was cut into a strip shape having a film thickness of 60 μm and a width of 0.3 mm to form a resin member 32a.

First, the strip-shaped resin member 32a was spirally wound around the metal treatment portion 31 and disposed in the same manner as in the second embodiment (arrangement step S1).
Subsequently, as shown in FIG. 13, the metal treatment portion 31 is sandwiched between the heating press molds 33 including a pair of stainless steel plates 33 a and 33 b, and the two sheets are heated and pressurized at 360 ° C. and 3 MPa. By moving the plates 33a and 33b alternately (in the direction of the arrow shown in FIG. 13), the metal treatment section 31 was rotated and heated and pressurized uniformly for about 30 minutes (crimping step S2). Furthermore, heating is stopped while continuing the pressurization and rotation, and it is left at room temperature to cool down until the metal treatment part 31 and the strip-shaped resin member 32a are lowered to room temperature (about 25 ° C.) (cooling step S3). . As a result, on the outer peripheral surface of the metal treatment portion 31, a spiral covering portion 32 made of Silky Bond (registered trademark) and having a height of about 30 μm and a width of about 0.5 mm was formed.

In the present embodiment, three types of windings of the covering portion 32 were produced: three turns, about seven turns, and about nine turns. At this time, the area of the metal treatment portion 31 is 0.4 mm × π × 15 mm = 18.85 mm ² , while the formed covering portion 32 has an area of one turn of about 0.63 mm ² . the total area of 1.89 mm ² in number of turns 3, 4.41mm ² to about 7 turns, a 8.82Mm ² at about 14 turns, about 10% area ratio of the coating portion to the metal treatment unit, respectively, about 23 %, About 50%.

  Also in Example 3, a pig liver cutting experiment was performed using ICC200 as a power source in the same manner as in the above-described Example. When the metal treatment part 31 having the covering part 32 is used, strong tissue fixation occurs even if intermittent energization is performed for 30 minutes or more in total in an incision mode (endoCUT mode) 50 W for an endoscopic treatment instrument. In addition, it was easy to remove the adhered tissue, and the treatment performance was not deteriorated. In the case of a treatment tool of the same shape made of a general SUS, it is necessary to remove the fixed matter in about 10 minutes at the beginning, the interval gradually becomes shorter, and finally the removal of the fixed matter becomes extremely difficult.

Example 4
Hereinafter, another embodiment of the present invention will be described in detail with reference to FIG. The treatment instrument 40 shown in the present embodiment is a seal forceps that stops hemostasis by sandwiching a bleeding part. This treatment instrument 40 has a metal treatment portion 41 having a width of 5 mm and a length of 25 mm, and a belt-shaped resin member 22a similar to that of Example 2 was adopted as the thermoplastic resin 2a.

  First, the belt-shaped resin member 22a is wound around the metal treatment portion 41 in a spiral shape with two different angles, or is wound in one reciprocation with different angles on the forward and return paths. (Placement step S1).

  Subsequently, in the same manner as in Example 2, heating and press-bonding were performed by a hot press mold 23 fitted to the outer surface of the metal treatment portion 41 to form a fluororesin protrusion having a lattice pattern of hydroxyl groups. As a result, on the outer surface of the metal treatment portion 41, a spiral covering portion 42 made of Silky Bond (registered trademark) and having a height of about 30 μm and a width of about 0.7 mm was formed.

In this example, three types of coatings of the coating part 42 were produced: 2 × 2, 5 × 2, and 8 × 2. At this time, the area of the metal treatment part 41 is 5 mm × 25 mm = 125 mm ² , while the formed covering part 42 has an area of about 3.5 mm ² , and the total area of the covering parts 42 is two. × 2 is about 14 mm ² , 5 × 2 is 35 mm ² , 8 × 2 is 56 mm ² , and the area ratio of the covering part to the metal treatment part is about 11%, about 28%, and about 45, respectively. %.

  In Example 4, using ICC200 as a power source, experiments were conducted on coagulation of gastric mucosa and sealing of blood vessels in pigs. At this time, intermittent energization was performed for 30 minutes or more under the condition of soft coagulation (coag) mode 80W. In the conventional stainless steel treatment instrument that does not have the covering portion 42, tissue adhesion was observed in some places. In the treatment instrument 40 of Example 4, the metal treatment portion 41 having the covering portion 42 has no tissue. Adhesion did not occur.

(Example 5)
Hereinafter, still another embodiment of the present invention will be described in detail with reference to FIG. The treatment instrument 50 shown in the present embodiment is a grasping forceps that grasps a bleeding site and stops bleeding, and is called a hemostasis forceps, and a contact surface on which a forceps surface 51a of the metal treatment portion 51 comes into contact with a living tissue. It has become. Further, as the thermoplastic resin 2a, a belt-shaped resin member 52a made of silky bond (registered trademark) with a film thickness of 30 μm and a width of 0.3 mm was adopted.

  First, the belt-shaped resin members 52a are arranged on a stainless steel plate at intervals of 1 mm, and the forceps surface 51a is brought into contact therewith (arrangement step S1). Subsequently, the forceps surface 51a was sandwiched between the heating press mold 53 made of a stainless steel plate so as to press the belt-shaped resin member 52a, and heated and pressed at 340 ° C. and 2 MPa for 10 minutes (crimping step S2). Then, it cooled, hold | maintaining pressurization until temperature became less than 250 degreeC, blowing dry air (cooling process S3). Thereafter, the strip-shaped resin member 52a protruding from the forceps surface 51a, which is unnecessary for using the metal treatment portion 51, was cut off. As a result, a covering portion 52 made of a strip-shaped resin member 52a having a height of about 30 μm and a width of about 0.5 mm made of Silky Bond (registered trademark) was formed on the forceps surface 51a.

  In the present example, the numbers were adjusted so that the area ratio of the covering portion 52 to the metallic treatment portion 51 was about 10%, about 25%, and about 45%, respectively.

  In Example 5, the ICC200 was used as the power source in the same manner as in Example 4 to conduct experiments on the coagulation of the porcine gastric mucosa and the blood vessel sealing. The energization conditions are the same as in Example 4. In the treatment instrument made of stainless steel that does not have the covering portion 52 made of the belt-shaped resin member 52a, tissue adhesion was observed in some places. However, in the metallic treatment portion 51 having the covering portion 52 of Example 5, Tissue attachment did not occur.

  In the fifth embodiment, the covering portion 52 made of the belt-shaped resin member 52a is formed only on the forceps surface 51a that becomes the portion where the metallic treatment portion 51 is engaged, but the other portion of the metallic treatment portion 51 is a living body. When performing a treatment that comes into contact with the tissue, the covering portion 52 may be formed by winding a belt-shaped resin member 52 a or the like around the metal treatment portion 51.

(Example 6)
Hereinafter, still another embodiment of the present invention will be described in detail with reference to FIG. The treatment instrument 60 shown in the present embodiment has a conical metal treatment part 61 made of a titanium alloy at the tip, and a vibrator (not shown) applies ultrasonic vibrations to the metal treatment part 61 so that the tissue is not in contact with the tissue. It is used mainly for the purpose of heating, solidifying and penetrating the tissue by generating frictional heat.

A band-shaped resin member 62a made of silky bond (registered trademark) having a film thickness of 60 μm and a width of 0.3 mm is spirally wound around the metal treatment portion 61 (arrangement step S1).
Thereafter, the metal treatment portion 61 is inserted and pressed into a hot press die 63 having a conical recess so as to fit into the conical shape of the metal treatment portion 61, and heated at 340 ° C. and 2.5 MPa. The pressure was maintained for about 30 minutes (pressure bonding step S2). Then, it left at normal temperature, maintaining the pressurization state by the heat press metal mold | die 63, and cooled to normal temperature (about 25 degree | times) (cooling process S3). As a result, on the outer surface of the metal treatment portion 61, a covering portion 62 made of a strip-shaped resin member 62a having a height of about 30 μm and a width of about 0.5 mm made of Silky Bond (registered trademark) was formed.

  In this example, the number of turns was adjusted so that the area ratio of the covering portion 62 to the metallic treatment portion 61 was about 10%, about 25%, and about 45%, respectively.

  In Example 6, a sonosurge generator manufactured by Olympus Co., Ltd. was used to conduct experiments on the penetration of the stomach wall of a pig and the cutting and sealing of blood vessels. As a result, in the metal treatment portion 61 having the covering portion 62, no strong tissue fixation occurred even when treatment was performed for 15 minutes or more in total. In addition, it was easy to remove the adhered tissue, and no reduction in treatment performance was observed. That is, it has been found that the ultrasonic transmission characteristics are not impaired even for a treatment portion using ultrasonic waves.

(Example 7)
Hereinafter, another embodiment of the present invention will be described in detail with reference to FIG. The treatment instrument 70 shown in the present embodiment has a rod-shaped metal treatment portion 71 at the tip, and a vibrator (not shown) applies ultrasonic vibration to the metal treatment portion 71 so that a resin member 74 and a metal treatment portion are provided. It is used to heat, coagulate, and cut a living tissue sandwiched between 71 and 71.
Further, as the thermoplastic resin, a strip-shaped resin member 72a made of Silky Bond (registered trademark) with a film thickness of 15 μm and a width of 0.2 mm was adopted.

  First, the belt-shaped resin member 72a was reciprocally wound around the metal treatment portion 71 in a spiral manner and arranged in a lattice shape (arrangement step S1). Then, the cylindrical shape was dug so that the metal treatment part 71 could be fitted, and it was heated and pressure-bonded under conditions of 360 ° C., 4 MPa, and 15 minutes by a heating press mold 73 having a liquid cooling pipe line inside. (Crimping step S2). Subsequently, the heating press mold 73 is cooled to room temperature (about 25 ° C.) while maintaining the pressurized state by a water cooling method in which water is allowed to flow in a pipe line arranged in the heating press mold 73 (cooling step). S3). As a result, on the outer surface of the metal treatment portion 71, a covering portion 72 made of a spiral resin member 72a having a height of about 10 μm and a width of about 0.3 mm made of Silky Bond (registered trademark) was formed.

  In this example, the number of turns was adjusted so that the area ratio of the covering portion 72 to the metallic treatment portion 71 was about 10%, about 25%, and about 45%, respectively.

  Also in this example, as in Example 6, a sonosurge generator manufactured by Olympus Co., Ltd. was used to conduct penetration of the stomach wall of a pig, blood vessel cutting, and sealing experiment. As a result, in the metal treatment part 71 having a partial covering structure by the covering part 72, even when the treatment for a total of 15 minutes or more was performed, firm tissue fixation did not occur. Further, in the metal treatment portion 71 having the covering portion 72, it was easy to remove the adhered tissue, and no reduction in treatment performance was observed. That is, it has been found that the ultrasonic transmission characteristics are not impaired even for a treatment portion using ultrasonic waves.

As mentioned above, although embodiment of this invention was explained in full detail with reference to drawings, the concrete structure is not restricted to this embodiment, The design change etc. of the range which does not deviate from the summary of this invention are included.
For example, in each of the embodiments of the present invention, Silky Bond (registered trademark) is used as the thermoplastic fluororesin. However, the present invention is not limited to this, and the melting point is at least from the temperature around the living tissue or the like when the treatment instrument is operated. Even if an appropriate material having a good bondability to the metal surface is employed, the same effects as those of the present invention can be obtained.

1, 11, 21, 31, 41, 51, 61, 71 Metal treatment part (treatment part)
2, 12, 22, 32, 42, 52, 62, 72 Cover 2a, 12a, 22a, 32a, 52a, 62a, 72a Resin member (thermoplastic resin)
3, 23, 33, 53, 63, 73 Heating press mold 10, 20, 30, 40, 50, 60, 70 Treatment tool (medical treatment tool)

Claims (11)

A medical treatment tool for performing a surgical procedure on a living tissue,
A medical treatment instrument comprising a covering portion coated with a thermoplastic resin mainly composed of a fluororesin, at least a part of a treatment portion that comes into contact with the living tissue.   The medical treatment instrument according to claim 1, wherein the covering portion is disposed in a region in the range of 1% to 50% of the outer surface of the treatment portion.   The medical treatment instrument according to claim 1 or 2, wherein the surface of the covering portion bulges outward from the outer surface of the treatment portion within a range of 0.005 mm to 0.2 mm.   The medical treatment instrument according to any one of claims 1 to 3, wherein the thermoplastic resin is a thermoplastic fluororesin having a hydroxyl group.   The medical treatment instrument according to any one of claims 1 to 4, wherein the covering portion is arranged in a line shape, a dot shape, or a lattice shape on an outer surface of the treatment portion.   The medical treatment instrument according to any one of claims 1 to 5, wherein the treatment portion has electrical conductivity.   The medical treatment instrument according to any one of claims 1 to 6, wherein the treatment section is capable of ultrasonic vibration.   The medical treatment instrument according to any one of claims 1 to 7, wherein the treatment section is made of stainless steel, titanium, a titanium alloy, or metal glass. A method of manufacturing a medical treatment instrument for performing a surgical procedure on a living tissue,
An arrangement step of arranging a thermoplastic resin containing a fluorine compound having a hydroxyl group on at least a part of the outer surface of the treatment portion that comes into contact with the living tissue;
A crimping step of thermocompression bonding while pressing the thermoplastic resin against the treatment portion;
And a cooling step of cooling the thermoplastic resin and the treatment portion in a state where the thermoplastic resin is pressed against the treatment portion.   10. The medical treatment according to claim 9, wherein the crimping step crimps the thermoplastic resin to the treatment portion at a temperature, pressure, and time in a range of 320 ° C. to 360 ° C., 1 to 4 MPa, and 1 to 30 minutes. Method of manufacturing a treatment tool.   The method for manufacturing a medical treatment instrument according to claim 9 or 10, wherein the cooling step maintains the pressure until the temperature of the treatment portion to which the thermoplastic resin is pressure bonded is less than 305 ° C.

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