The present disclosure relates to a medical heater, a treatment tool, and a treatment tool manufacturing method.
There is a known treatment tool that applies energy to a site as a target of treatment (hereinafter, referred to as a target site) in a biological tissue for treatment of the target site (refer to US 2015/0327909 A, for example).
The treatment tool described in US 2015/0327909 A includes a pair of gripping members to grip the target site. The gripping member includes a medical heater that generates heat when energized, and a treatment member that comes into contact with the target site when the target site is gripped by the pair of gripping members. The treatment tool allows the heat from the medical heater to be transferred to the target site gripped with the pair of gripping members via the treatment member. This achieves treatment of the target site.
Furthermore, a medical heater described in US 2015/0327909 A includes a substrate and a conductive portion provided on the substrate. The conductive portion includes first and second connecting portions to which individual wiring members are electrically connected, and a heat generating portion that generates heat when energized. The first and second connecting portions are disposed side by side in a width direction of the substrate on the proximal end side of the substrate. Furthermore, the heat generating portion has a substantially U-shape extending from the proximal end side toward the distal end side, folded back on the distal end side, and extending back to the proximal end side on the substrate. In addition, either end of the heat generating portion is electrically connected to the first and second connecting portions, individually. That is, the conductive portion has two electric paths parallel to each other in the width direction of the substrate.
In some embodiments, a medical heater includes: a substrate having a first plate surface and a second plate surface forming front and back surfaces of the substrate, the substrate being electrically insulating and flexible; and a conductive portion provided on the first plate surface. The substrate is folded back in a state where the first plate surface forms an outer surface in a longitudinal direction of the substrate, the conductive portion includes: a pair of connecting portions to which wiring members are electrically connected, each connecting portion being provided at either end of the substrate in the longitudinal direction; a heat generating portion configured to generate heat when energized; and an electric path portion that is connected from the connecting portions to the heat generating portion so as to energize the heat generating portion, and the heat generating portion has a configuration in which a resistance value of the heat generating portion is higher than resistance values of other parts in the conductive portion, and a thickness measurement of at least a part of the heat generating portion is smaller than thickness measurements of other parts in the conductive portion.
In some embodiments, a treatment tool includes: a treatment member having a treatment surface on which treatment of a biological tissue is performed and an installation surface forming front and back surfaces of the treatment member with the treatment surface; and a medical heater configured to heat the treatment member. The medical heater includes: a substrate having a first plate surface and a second plate surface forming front and back surfaces of the substrate, the substrate being electrically insulating and flexible; and a conductive portion provided on the first plate surface, the substrate is folded back in a longitudinal direction of the substrate in a state where the first plate surface forms an outer surface of the substrate, the conductive portion includes: a pair of connecting portions to which wiring members are electrically connected, each connecting portion being provided at either end of the substrate in the longitudinal direction; a heat generating portion configured to generate heat when energized; and an electric path portion that is connected from the connecting portions to the heat generating portion so as to energize the heat generating portion, the heat generating portion has a configuration in which a resistance value of the heat generating portion is higher than resistance values of other parts in the conductive portion, and a thickness measurement of at least a part of the heat generating portion is smaller than thickness measurements of other parts in the conductive portion, and the medical heater is installed in a state where the heat generating portion faces the installation surface.
In some embodiments, a treatment tool manufacturing method includes: forming a conductive portion including a heat generating portion, on a first plate surface of a substrate; folding back the substrate in a longitudinal direction of the substrate in a state where the first plate surface forms an outer surface of the substrate so as to form a medical heater; and installing the medical heater on a treatment member having an installation surface on which treatment of a biological tissue is performed in a state where the heat generating portion faces the installation surface. The conductive portion includes: a pair of connecting portions to which wiring members are electrically connected, each connecting portion being provided at either end of the substrate in the longitudinal direction; the heat generating portion configured to generate heat when energized; and an electric path portion that is connected from the connecting portions to the heat generating portion so as to energize the heat generating portion, and formation of the conductive portion is performed in a state where a thickness measurement of at least a part of the heat generating portion is smaller than thickness measurements of other portions in the conductive portion.
The above and other features, advantages and technical and industrial significance of this disclosure will be better understood by reading the following detailed description of presently preferred embodiments of the disclosure, when considered in connection with the accompanying drawings.
Hereinafter, modes for carrying out the disclosure (hereinafter referred to as embodiments) will be described with reference to the drawings. The disclosure is not limited to the embodiments described below. In the drawings, same reference signs are attached to the same components.
Schematic Configuration of Treatment System
The treatment system 1 applies thermal energy to a site as a treatment target (hereinafter, referred to as a target site) in a biological tissue, and thereby achieves treatment of the target site. Here, the treatment typically includes coagulation and incision of the target site. As illustrated in
Configuration of Treatment Tool
The treatment tool 2 is a surgical treatment tool for performing the treatment of a target site through the abdominal wall, for example. As illustrated in
The handle 5 is a part held by a surgeon. As illustrated in
The shaft 6 has a substantially cylindrical shape. In the following, one side running along a central axis Ax of the shaft 6 will be referred to as a distal end side Ar1 (
Configuration of Gripping Portion
The gripping portion 7 is a portion that is used for treatment of the target site while gripping the target site. As illustrated in
The first and second gripping members 8 and 9 are configured to be openable/closable in a direction of arrow Y1 (
Configuration of First Gripping Member
In
The support member 10 has an elongated shape extending in a longitudinal direction (left-right direction (direction along the central axis Ax) in
Examples of the material constituting the support member 10 described above include a metal material such as stainless steel or titanium.
The heat insulating member 11 has an elongated shape extending in the longitudinal direction of the gripping portion 7, and is fixed to the upper surface of the support member 10 in
There is provided a recess 111 on the upper surface of the heat insulating member 11 in
Examples of the material constituting the heat insulating member 11 described above include a resin material having a low thermal conductivity such as polyetheretherketone (PEEK). That is, by arranging the heat insulating member 11 having a low thermal conductivity between the treatment member 12, the medical heater 13, and the support member 10, it is possible to efficiently transfer the heat from the medical heater 13 to the treatment member 12.
The treatment member 12 has an elongated shape extending in the longitudinal direction of the gripping portion 7 and is fixed in the recess 111.
The upper surface of the treatment member 12 in
Although the first embodiment is an example in which the treatment surface 121 is formed of a flat surface, the treatment surface 121 is not limited to this and may be formed of other shapes such as a protruding shape or a recessed shape. The same applies to a gripping surface 91 described below.
Furthermore, on an installation surface 122 of the treatment member 12, there is a recess 123 (
Examples of the material constituting the treatment member 12 described above include materials with high thermal conductivity, such as copper, silver, aluminum, molybdenum, tungsten, graphite, or a composite material of these.
The medical heater 13 is a sheet-type heater that partially generates heat when energized. As illustrated in
The substrate 14 is a sheet-like flexible substrate formed of a resin material having electrical insulation such as polyimide. The substrate 14 has an elongated shape, and includes: first and second wide portions 141 and 142 located at either end in the longitudinal direction (in
Here, the width measurement (length measurement in the up-down direction in
Among the first plate surface 14a (
The first and second connecting portions 151 and 152 correspond to the connecting portions according to the disclosure. As illustrated in
The heat generating portion 153 is connected, at one end of the heat generating portion 153, to the first connecting portion 151 and extends, on the other end side of the heat generating portion 153, linearly toward the second connecting portion 152 side.
The electric path portion 154 is a portion provided as an energizing path to the heat generating portion 153, and is connected, at one end side of the electric path portion 154, to the other end of the heat generating portion 153, while extends, on the other end side of the electric path portion 154, linearly toward the second connecting portion 152 side. Here, one end of the electric path portion 154 connected to the heat generating portion 153 corresponds to a heat generating-side end 154a (
As described above, the conductive portion 15 is provided on the first plate surface 14a, in a state of being connected in series in the order of the first connecting portion 151, the heat generating portion 153, the electric path portion 154, and the second connecting portion 152 in the longitudinal direction of the substrate 14.
In addition, with the first and second connecting portions 151 and 152, the heat generating portion 153, and the electric path portion 154 set to have predetermined total lengths and cross-sectional areas, the heat generating portion 153 is set to have a resistance value that is higher than the values in the other parts in the conductive portion 15, namely, the first and second connecting portions 151 and 152, and the electric path portion 154. Therefore, when a voltage is applied to the first and second connecting portions 151 and 152 via the pair of lead wires C1 under the control of the control device 3, the heat generating portion 153 mainly generates heat.
Specifically, in the first embodiment, the width measurements (length measurements in the up-down direction in
Furthermore, in the first embodiment, by appropriately setting the material, the total length, and the cross-sectional area, the conductive portion 15 is set to have a resistance value (hereinafter, referred to as a heater resistance) 30 [Ω] to 150 [Ω] in the conductive portion 15 at room temperature. Here, the width measurement of the conductive portion 15 (length measurement in the up-down direction in
The passivation film 16 is constituted with nickel fluoride and covers a part of the surface of the conductive portion 15 as illustrated in
The medical heater 13 described above is fixed to the bottom surface of the recess 123 by an adhesive sheet 17 (
Here, the adhesive sheet 17 is located between the bottom surface of the recess 123 and the medical heater 13 so as to adhere the bottom surface and the medical heater 13. The adhesive sheet 17 is formed by mixing a material having high thermal conductivity, high temperature resistance, and adhesiveness, for example, epoxy resin, with a ceramic having high thermal conductivity, such as alumina and aluminum nitride.
As illustrated in
In the following, for convenience of explanation, the region on the first connecting portion 151 side with respect to the folding line Ln will be referred to as a treatment-side region Sp1, and the region on the second connecting portion 152 side with respect to the folding line Ln will be referred to as a back-side region Sp2.
As illustrated in
The substrate 14 is folded back with reference to the folding line Ln as described above and is fixed to the bottom surface of the recess 123 with the adhesive sheet 17 in a state where the treatment-side region Sp1 faces the bottom surface.
Configuration of Second Gripping Member
The second gripping member 9 has an elongated shape extending in the longitudinal direction of the gripping portion 7. In the second gripping member 9, the proximal end side Ar2 is pivotably supported with respect to the shaft 6 about a fulcrum P1 (
Here, the lower surface in
The first embodiment has described an exemplary configuration in which the first gripping member 8 (support member 10) is fixed to the shaft 6, and the second gripping member 9 is pivotally supported by the shaft 6. However, the disclosure is not limited to this configuration. For example, it is allowable to adopt a configuration in which both the first and second gripping members 8 and 9 are pivotally supported with respect to the shaft 6, and the first and second gripping members 8 and 9 perform open/close operation by pivot movements individually. Furthermore, for example, it is also allowable to adopt a configuration in which the first gripping member 8 is pivotally supported with respect to the shaft 6 while the second gripping member 9 is fixed to the shaft 6, and the first gripping member 8 performs open and close operations with its pivot movement with respect to the second gripping member 9.
Configuration of Control Device and Foot Switch
The foot switch 4 is a part operated by the surgeon with own foot. Treatment control performed by the control device 3 is executed in accordance with the operation on the foot switch 4.
Note that, the device used for execution of the treatment control is not limited to the foot switch 4, and other devices such as manual operation switches or the like may be employed.
The control device 3 includes a central processing unit (CPU) or the like, and executes treatment control of controlling the treatment tool 2 to operate in accordance with a predetermined program, thereby performing treatment of a target site.
Operation of Treatment System
Next, operations of the treatment system 1 described above will be described.
The surgeon holds the treatment tool 2 by hand and inserts the distal end (a part of the gripping portion 7 and the shaft 6) of the treatment tool 2 into the abdominal cavity through the abdominal wall using a trocar, for example. The surgeon also operates the operation knob 51. The surgeon grips the target site by the gripping portion 7. Thereafter, the surgeon operates the foot switch 4. Subsequently, the control device 3 executes the following treatment control.
The control device 3 applies a voltage to the first and second connecting portions 151 and 152 via the pair of lead wires C1. Here, the control device 3 measures the heater resistance based on the voltage value and the current value supplied to the conductive portion 15 by using a voltage drop test method, for example. Furthermore, the control device 3 refers to resistance temperature characteristics measured in advance. The resistance temperature characteristics are characteristics indicating a relationship between the heater resistance and the temperature of the heat generating portion 153 (hereinafter referred to as the heater temperature). The control device 3 controls the heater resistance to a target resistance value corresponding to the target temperature in the resistance temperature characteristics while changing the electric power supplied to the conductive portion 15. With this control, the heater temperature is controlled to the target temperature. That is, the heat from the heat generating portion 153 controlled to the target temperature is transferred to the target site through the treatment member 12.
The treatment control described above makes it possible to achieve incision with coagulation in the target site.
Treatment Tool Manufacturing Method
Next, a method for manufacturing the above-described treatment tool 2 will be described.
First, as illustrated in
After step S1, the operator uses masking tape MT1 (
After step S2, as illustrated in
The first and second metal films 101 and 102 are constituted as the conductive portion 15 as illustrated in
After step S3, the operator uses masking tape MT2 (
After step S4, the operator places the substrate 14 in an atmosphere of a gas containing fluorine and performs heating at a predetermined temperature so as to perform surface modification of the region on the surface of the conductive portion 15 other than the masked third region MA2 (step S5). With this process, as illustrated in
Note that in a case of forming the passivation film 16 on a part of the surface of the heat generating portion 153 and the surface of the heat generating-side end 154a, it is only needed to mask regions excluding a part of the surface of the heat generating portion 153 and the surface of the heat generating-side end 154a.
After step S5, as illustrated in
According to the first embodiment described above, the following effects are obtained.
In the medical heater 13 according to the first embodiment, the conductive portion 15 is provided on the first plate surface 14a, in a state of being connected in series in the order of the first connecting portion 151, the heat generating portion 153, the electric path portion 154, and the second connecting portion 152 in the longitudinal direction of the substrate 14. Furthermore, the substrate 14 is folded back with reference to the folding line Ln in a state where the first plate surface 14a constitutes the outer surface of the medical heater 13.
That is, the substrate 14 having electrical insulation is present between the treatment-side region Sp1 in the conductive portion 15 and the back-side region Sp2 in the conductive portion 15. This makes it possible to prevent an occurrence of short circuit between the treatment-side region Sp1 in the conductive portion 15 and the back-side region Sp2 in the conductive portion 15.
Furthermore, the conductive portion 15 has a configuration extending in the longitudinal direction (left-right direction in
Meanwhile, in the medical heater described in US 2015/0327909 A, the heat generating portion has a shape extending while meandering in a wavy shape in order to increase the resistance value of the heat generating portion. That is, the known technique has a reduced width measurement of the heat generating portion with the elongated total length of the heat generating portion. In such a configuration, when the heat generating portion is covered with the adhesive sheet, a void might be formed between the peaks or between valleys of the wavy shape in the heat generating portion. Heating the heat generating portion with the void might produce a state in which the heat is trapped in the void, causing overheating in the part of the heat generating portion in proximity to the void, leading to disconnection of the part.
Fortunately, however, in the medical heater 13 according to the first embodiment, the thickness measurement of the heat generating portion 153 is smaller than that of the first and second connecting portions 151 and 152 and the electric path portion 154. That is, it is possible to reduce the cross-sectional area of the heat generating portion 153, eliminating the need to have a wavy shape of the heat generating portion as described in US 2015/0327909 A, enabling the width measurement of the heat generating portion 153 to be set to the large width measurement same as the measurements of the first and second connecting portions 151 and 152 and the electric path portion 154. Therefore, by achieving the setting of large width measurement of the heat generating portion 153, it is possible to avoid disconnection of the heat generating portion 153.
Furthermore, in the medical heater 13 according to the first embodiment, the heat generating portion 153 is constituted with a material containing nickel.
Furthermore, the surface of the heat generating portion 153 is covered with the passivation film 16 constituted with nickel fluoride.
Here, it is assumed a case where in the course of the use of the treatment tool 2, a part of the medical heater 13 has been removed from the bottom surface of the recess 123, leading to a state where a part of the treatment-side region Sp1 on the first plate surface 14a is exposed in the recess 123. Even in this case, since the surface of the heat generating portion 153 is covered with the passivation film 16, it is possible to suppress the corrosion or oxidation of the heat generating portion 153 or occurrence of rusting on the heat generating portion 153 that would cause a change in the resistance temperature characteristics measured in advance. That is, even when the treatment tool 2 is used for a long period of time, the heater temperature can be controlled to the target temperature by using the resistance temperature characteristics measured in advance.
In particular, the heat generating portion 153 is constituted with a material containing nickel. The passivation film 16 is constituted with nickel fluoride.
Therefore, by exposing the surface of the heat generating portion 153 to an atmosphere containing fluorine, the passivation film 16 is formed by surface modification of the heat generating portion 153. That is, there is no need to provide a special device using a chemical vapor deposition or the like in the formation of the passivation film 16, making it possible to reduce the manufacturing cost of the medical heater 13. Furthermore, since the passivation film 16 is formed by surface modification of the heat generating portion 153, the passivation film 16 can be a dense film, and this enables an extremely small thickness measurement of the passivation film 16. Therefore, the passivation film 16 would not deteriorate the thermal conductivity from the heat generating portion 153 to the treatment member 12. That is, the treatment performance of the target site would not deteriorate.
Furthermore, in the medical heater 13 according to the first embodiment, the electric path portion 154 is provided across the folding line Ln. That is, in the state where the substrate 14 is folded back with reference to the folding line Ln, the electric path portion 154 is folded back. Here, the electric path portion 154 has a larger thickness measurement than the heat generating portion 153. Therefore, as compared with the case where the heat generating portion 153 is folded back, it is possible to suppress the disconnection of the conductive portion 15, and thus possible to sufficiently ensure the durability of the conductive portion 15.
Furthermore, in the medical heater 13 according to the first embodiment, the passivation film 16 covers not merely the surface of the heat generating portion 153 but also the surface of the heat generating-side end 154a of the electric path portion 154. Here, the heat generating-side end 154a is a portion connected to the heat generating portion 153, and thus, likely to have a high temperature. That is, in the course of use of the treatment tool 2, corrosion or oxidation of the heat generating-side end 154a and rusting at the heat generating-side end 154a are likely to occur.
Therefore, by covering the surface of the heat generating-side end 154a with the passivation film 16, it is possible to suppress corrosion or oxidation of the heat generating-side end 154a or occurrence of rusting on the heat generating-side end 154a that can cause a change in the resistance temperature characteristics measured in advance. That is, even when the treatment tool 2 is used for a long period of time, the heater temperature can be controlled to the target temperature by using the resistance temperature characteristics measured in advance.
Furthermore, in the first embodiment, formation of the conductive portion 15 is performed by forming the first metal film 101 on the first plate surface 14a by electroless plating (step S1), and by forming the pair of second metal films 102 on the first metal film 101 by electroplating (step S3).
This facilitates formation of the heat generating portion 153, the first and second connecting portions 151 and 152, and the electric path portion 154 having different thickness measurements from each other.
Next, a second embodiment will be described.
In the following description, identical reference numerals are given to the components similar to those in the first embodiment described above, and detailed description thereof will be omitted or simplified.
As illustrated in
The cover member 18 is provided across the folding line Ln on the first plate surface 14a of the substrate 14. Specifically, the cover member 18 extends from a position at which a predetermined gap is provided toward the second connecting portion 152 side from the passivation film 16, onto the second connecting portion 152 side so as to cover the surface of the electric path portion 154. That is, the cover member 18 covers regions of the electric path portion 154 other than the heat generating-side end 154a.
Examples of the cover member 18 described above include a material having electrical insulation, such as a coverlay film, a sealing material, a melt layer of polyimide.
According to the second embodiment described above, the following effects are obtained in addition to the effects similar to the case of the first embodiment described above.
The medical heater 13A according to the second embodiment includes the cover member 18.
Therefore, with the presence of the cover member 18, it is possible to improve the watertightness of the back-side region Sp2 in the conductive portion 15. Furthermore, since the cover member 18 has electrical insulation, it is possible to prevent an occurrence of a short circuit between the treatment-side region Sp1 in the conductive portion 15 and the back-side region Sp2 in the conductive portion 15 even when a liquid enters the recess 111.
Furthermore, the cover member 18 covers regions of the electric path portion 154 other than the heat generating-side end 154a. That is, since the cover member 18 is provided at a position avoiding the heat generating-side end 154a, which is likely to have a high temperature, there will be no concern about a case where the cover member 18 has a high temperature, making it possible to prevent the removal of the cover member 18 from the first plate surface 14a.
While the above is description of the modes for carrying out the disclosure, the disclosure should not be limited by only the first and second embodiments described above.
Although, in the above-described first and second embodiments, a configuration in which thermal energy is applied to the target site is adopted, the disclosure is not limited to this. It is also allowable to adopt a configuration in which high frequency energy or ultrasonic energy is applied in addition to the thermal energy. Note that, “applying high frequency energy to the target site” means sending a radio frequency current through the target site. Furthermore, “applying ultrasonic energy to the target site” means applying ultrasonic vibration to the target site.
In the above-described first and second embodiments, the medical heaters 13 or 13A according to the disclosure is provided only on the first gripping member 8. However, the disclosure is not limited to this, and the medical heaters 13 or 13A according to the disclosure may be provided on both of the first and second gripping members 8 and 9.
In the above-described first and second embodiments, an example in which a material containing nickel is used as the material constituting the conductive portion 15 is exemplified. However, the disclosure is not limited to this, and another material can be adopted as long as it is any of stainless steel, nickel, nickel alloy, palladium, platinum, gold, and silver, or a combination of these.
In the above-described first and second embodiments, the first and second metal films 101 and 102 are formed by electroless plating and electroplating, respectively. However, the film formation is not limited to this and the films may be formed by sputtering.
According to the medical heater, the treatment tool, and the treatment tool manufacturing method according to the disclosure, it is possible to reduce a width measurement of a substrate, while preventing the short circuit of the conductive portion provided on the substrate.
Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the disclosure in its broader aspects is not limited to the specific details and representative embodiments shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.
This application is a continuation of International Application No. PCT/JP2018/033619, filed on Sep. 11, 2018, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2018/033619 | Sep 2018 | US |
Child | 17185307 | US |