Patent Application
20170290623
This invention relates to an energy device for surgical operation provided with a function capable of performing incision of biological tissue, coagulation and hemostasis by acting energy through microwave, radio-frequency wave or ultrasonic wave represented by heat to a target portion of a body.
In general, the energy device for surgical operation is used for transmitting microwave, radio-frequency wave or ultrasonic wave from an operational area portion to a target portion of a body to perform incision of biological tissue, bleed coagulation from the tissue (hemostasis) or both of incision and coagulation by these actions. In the energy device for surgical operation, biological tissue is fixed to the operational area portion in the treatment to the biological tissue, whereby an impedance, discharging property, electric conductivity and heat conductivity of an electrode and transmission characteristics of energy are changed or smoke is emitted or treating properties such as cutting, coagulating performance, stop bleeding and the like may be deteriorated. As a countermeasure to such problems, it is known to form a coating layer hardly fixing the biological tissue to the operational area portion. The conventional art will be described with reference to documents 1-4 below.
In Patent Document 1 is described that the conventional energy device for surgical operation is constructed with a portion made of a metal and having an electric conductivity obtained by forming irregularities on a surface of an operational area portion made of a metal, filling a resin having a low surface energy such as fluorine resin or the like in concave portions and then making the surface relatively smooth, and a portion made of a low surface energy resin and having an insulation property and a low surface energy. In the energy device for surgical operation of such a construction, a fluorine polymer embedded in the irregularities on the surface of the operational area portion is partly exposed to reduce fixation of biological tissue.
In Patent Document 2 is disclosed that at least a part of the surface of the operational area portion made of a metal in the conventional energy device for surgical operation is constructed with a thermoplastic fluorine resin. In the energy device for surgical operation of such a construction, the thermoplastic fluorine resin disposed in the surface of the operational area portion is strongly pushed onto biological tissue, while an exposed portion of the metal is weakly pushed thereon, whereby the fixation of the biological tissue to the operational area portion is reduced.
In the conventional energy device for surgical operation of Patent Document 3, the surface of the operational area portion made of a metal and coarsened by blast treatment is constructed with a primer layer containing polysiloxane resin and an outermost coating of fluorine polymer made of silicone elastomer based polymer. The outermost coating is non-uniform in the thickness and an edge part of a blade for surgical operation is thin and has a thickness of 76-510 μm on its main surface. In the energy device for surgical operation of such a construction, high-frequency wave is preferentially conducted in the edge part having a thin coating to incise and coagulate biological tissue, while the main surface not conducting the high-frequency wave is free of heat affection and hence the fixation of biological tissue is reduced.
In the conventional energy device for surgical operation of Patent Document 4, the surface of the operational area portion made of stainless steel is constructed with an oxide layer oxidized by heat treatment and a releasing material containing silicone. In the energy device for surgical operation of such a construction, the coating with non-uniform thickness is obtained to reduce the fixation of biological tissue similarly in Patent Document 3 and at the same time the adhesion property is improved by the formation of the oxide layer.
Patent Document 1: JP-A-H10-500051
Patent Document 2: JP-A-2011-72324
Patent Document 3: Japanese Patent No. 3182153
Patent Document 4: Japanese Patent No. 4502565
In the energy device for surgical operation disclosed in Patent Document 1, since the fluorine polymer is merely embedded in the concave portions of the surface for preventing the fixation of biological tissue, there is a fear of dropout. Also, the convex portions having an electric conductivity is exposed even when the fluorine polymer is disposed partly, so that the effect of sufficiently preventing the fixation cannot be developed. Furthermore, the document describes a step of subjecting an electrode support to coarsening by blasting or the like or mechanical deformation surface finishing by buffing or the like, and suggests that the step cannot be applied to an electrode support of a complicated form.
In the energy device for surgical operation described in Patent Document 2, the thermoplastic fluorine resin for preventing the fixation of biological tissue is arranged in at least a part of the operational area portion in form of line,or dot or lattice, but the base material of a metal having an electric conductivity is exposed, so that the effect of sufficiently preventing the fixation cannot be developed. Also, the formation of the thermoplastic fluorine resin is performed by heating and pressing at 1-4 MPa and 320-340° C. for 1-30 minutes, so that there is a fear of deforming the base material and there is an issue that it cannot be applied to the complicated form.
In the energy device for surgical operation described in Patent Document 3, the primer layer containing polysiloxane resin and the outermost coating of fluorine polymer made of silicone elastomer based polymer are applied for preventing the fixation of biological tissue. Since the outermost coating is formed by an immersion treatment, the thickness becomes thin in the edge part of the blade and thick in the flat part thereof. By utilizing this feature is introduced energy into the edge part having a thin thickness, whereby the incision and coagulation of biological tissue can be performed, while the flat part having a thick thickness is insulated thermally, whereby the fixation of biological tissue can be prevented. In this method, however, the thickness is dependent on the form of the operational area portion, so that the introduction part cannot be designed arbitrarily. Since the adhesion force of the primer layer containing polysiloxane resin to the base material is not high, a step of performing sand blasting with aluminum oxide media is described in a working example of the production method as a countermeasure, which cannot be applied to a complicated form.
In the energy device for surgical operation described in Patent Document 4, the releasing material containing silicone is applied to the surface of the operational area portion made of stainless steel for preventing the fixation of biological tissue. As a method of adhering the releasing material containing silicone is described that an iron oxide layer having a highest adhesion force is formed on a ground material before the coating of silicone by subjecting the surface of the operational area portion in the base material of stainless steel to a heat treatment at 750° F. for 30 minutes in the examples without requiring a middle layer or a coarsened layer. However, this method has an issue that the base material is deformed or rusting is easily caused by sensitization. Also, the base material is limited to an iron based material.
The invention is made for solving the above issues of the prior art and an object thereof is to provide an energy device for surgical operation capable of preventing the fixation of biological tissue by forming a coating layer having a good adhesiveness and applicable to a complicated form.
In order to achieve the above object, the invention is an energy device for surgical operation having an operational area portion for transmitting energy to a body target portion, characterized in that a coating layer formed on an outer periphery of a base material constituting the operational area portion is comprised of a base coating formed on the base material and an outermost coating formed on the base coating, and the base coating is silicon oxide or a mixture containing silicon oxide, while the outermost coating is polysiloxane, a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane.
In the energy device for surgical operation of the above construction, the fixation of biological tissue to the operational area portion is suppressed by water-repellent and oil-repellent actions of the outermost coating having a low surface energy. In the energy device for surgical operation of the above construction, good adhesiveness is obtained by strong adhesion of the base coating to the base material and the outermost coating. Further, the base coating can be formed at room temperature or about 150° C., so that the deformation of the base material due to heat affection can be suppressed.
As a preferable embodiment of the invention, a surface roughness of the base material constituting the operational area portion is not more than 3 μm as Ra value before the formation of the coating layer, preferably 0.01-1.0 μm. In the energy device for surgical operation of this construction, the surface can be adjusted arbitrarily by electrolytic polishing, buffing, blast treatment with spherical or polygonal ceramic abrasive grains or laser irradiation to select the surface form and roughness effective for suppressing the fixation of biological tissue.
As a further preferable embodiment of the invention, the thickness of the base coating is 0.05-10 μm, preferably 0.1-1.0 μm. In the energy device for surgical operation of this construction, the base coating is a thin coating, so that the formation of uniform coating can be attained even in the base material of a complicated form. The fixation of biological tissue can be prevented when the thickness of the outermost coating comprised of polysiloxane or a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane is not less than 0.1 μm.
Moreover, the base material constituting the operational area portion is a metal, preferably stainless steel, titanium or a titanium alloy, or a resin, preferably polyimide or PEEK resin. In the energy device for surgical operation of this construction, the above base material can be generally taken as a material having a biological safety and provides good adhesiveness to the base coating. Also, the base material constituting the operational area portion is applicable to portions other than the base material and is not limited.
As another preferable embodiment of the invention, energy transmitted from the operational area portion to biological tissue is microwave, radio-frequency wave or ultrasonic wave. In the energy device for surgical operation of this construction, the fixation of body tissue can be suppressed by applying the above coating even in any energy used in the incision of body tissue, coagulation or stop bleeding.
As the other preferable embodiment of the invention, the energy device for surgical operation is a surgical knife, tweezers, forceps or snare used in surgical operation. The energy device for surgical operation of this construction can be applied as surgical knife, tweezers, forceps or snare particularly used in the surgical operation by uniformly coating the whole periphery of the operational area portion with the coating layer for suppressing the fixation of body tissue.
As mentioned above, the invention can provide an energy device for surgical operation capable of suppressing fixation of body tissue in an operational area portion of the energy device for surgical operation.
In actual use, the operational area portion 3 of the electrosurgical knife 1 is moved closer to a biological body to be processed (not shown) and microwave, radio-frequency wave or ultrasonic wave is transmitted from the operational area portion 3 to the biological body to perform incision of body tissue or coagulation of bleeding from the tissue (hemostasis) or both of incision and coagulation.
The feature of the invention lies in a construction of the operational area portion 3 shown in
In the aforementioned embodiment, a thickness of the base coating 12 is preferably 0.1-10 μm, more preferably 0.1-1.0 μm. In this preferable embodiment, the base coating 12 can be formed uniformly in the base material 11 of a complicated form because it is a thin coating. Further, the outermost coating made from polysiloxane, a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane can prevent fixation of body tissue at a thickness of 0.1 μm. The thickness of the outermost coating 13 can be adjusted by application of plural times, but sufficient effects can be actually obtained at 0.1 μm.
In the above embodiment, a surface roughness of the base material 11 constituting the operational area portion 3 is preferably not more than 3 μm as Ra value before the formation of the coating layer 14, more preferably 0.01-1.0 μm. In this preferable example, the base material 11 can be adjusted to an arbitrary surface by electrolytic polishing, buffing, blast treatment with spherical or polygonal ceramic abrasive grains or laser irradiation to select surface form and roughness effective for suppressing fixation of body tissue. Also, the base material 11 constituting the operational area portion 3 is a metal, preferably stainless steel, titanium or titanium alloy, or a resin, preferably polyimide or PEEK resin. In this preferable example, it may be usually used as a material having a safeness to biological body and has a good adhesiveness to the base coating 12.
In the above embodiment, energy transmitted to the operational area portion 3 is preferable to be microwave, radio-frequency wave or ultrasonic wave. In this preferable embodiment, even if the energy used in the incision of body tissue, coagulation or hemostasis is any energy, the fixation of body tissue can be suppressed by forming the above coating layer 14. Also, the energy device for surgical operation can be used as a surgical knife, tweezers, forceps or snare used in the surgical operation. The energy device for surgical operation of this construction can be applied to the above product group by uniformly coating the whole periphery of the operational area portion with the coating layer suppressing the fixation of body tissue.
As a method of forming the base coating 12 to the base material 11, there can be used the conventionally known various methods. For example, flow coating, dipping, spraying or CVD method can be used.
As a method of forming the outermost coating 13 to the base material 11, there can be used the conventionally known various methods such as flow coating, dipping, spraying methods.
There will be described examples in the energy device for surgical operation according to the above embodiments below.
A test specimen having a coating layer shown in
As seen from the results of Table 1, the fixation of body tissue can be suppressed by water-repellent and oil-repellent actions of the outermost coating 24 having a low surface energy in the test specimen of the invention example as compared to the test specimens of the comparative examples.
There is examined a base coating in the coating layer according to the invention. After a surface of a base material made of SUS 304 steel with 25 mm (width)×100 mm (length)×1 mm (thickness) is subjected to a pretreatment according to Example 1, there are provided a test specimen of an invention example obtained by applying a base coating made of silicon oxide and faulting an outermost coating made from a compound containing a fluorinated polysiloxane, a test specimen of an invention example obtained by forming a base coating made from an iron oxide through a heat treatment and then forming an outermost coating made from a compound containing a fluorinated polysiloxane, and a test specimen of a comparative example obtained by directly forming an outermost coating made from a compound containing a fluorinated polysiloxane. An evaluation of adhesiveness is performed by a rubbing test (ASTM D4752) with respect to the test specimens of the invention examples and the comparative example. The results are shown in Table 2.
As seen from the results of Table 2, the test specimens of the invention examples having the base coating made of silicon oxide have many reciprocating numbers by rubbing test as compared to the test specimen of the comparative example forming no base coating and the test specimen of the comparative example forming iron oxide as a base coating through heat treatment and is high in the adhesiveness of the coating layer. Further, the test specimen of the comparative example forming iron oxide as the base coating through heat treatment causes the deformation in the formation of the base coating.
There is examined a preferable example of a thickness of a base coating in the coating layer according to the invention. After a surface of a base material made of rod SUS 304 steel with 2.7 mm (width)×10 mm (length) is subjected to a pretreatment according to Example 1, there are provided test specimens obtained by forming a base coating made from silicon oxide while varying a thickness within a range of 0.01 μm to 15.0 μm and then forming an outermost coating made from a compound containing a fluorinated polysiloxane thereon. Each of the test specimens is inserted into a pig liver and microwave is introduced at 50 W for 30 seconds to evaluate a coagulation property of tissue and a burning degree. The results are shown in Table 3.
As seen from the results of Table 3, when the thickness of the base coating made of silicon oxide is less than 0.05 μm, the burning degree becomes larger, while when the thickness exceeds 10 μm, the burning is not caused, but the coagulation property of tissue becomes lower. To this end, the thickness of the base coating made of silicon oxide is preferable to be a range of 0.05-10.0 μm.
There is examined a preferable example of a pretreatment to the base material according to the invention. After any surface roughness Ra is applied to a surface of a base material made from a rod SUS 304 steel of 2.7 mm (diameter)×10 mm (length) by electrolytic polishing, buffing, blast treatment with spherical or polygonal ceramic abrasive grains or laser irradiation, there are provided test specimens obtained by forming a base coating made of silicon oxide and an outermost coating made from a compound containing a fluorinated polysiloxane according to Example 1. Each of the test specimens is inserted into a pig liver and microwave is introduced at 50 W for 30 seconds to evaluate a a burning degree. The results are shown in Table 4.
As seen from the results of Table 4, when the surface roughness Ra of the base material is Ra: not more than 3.0 μm, further preferably Ra: 0.01-1.0 μm, the burning degree of liver tissue is particularly small and the fixation of body tissue can be suppressed. To this end, the surface roughness of the base material is preferable to be Ra: not more than 3.0 μm, and more preferable to be Ra: 0.01-1.0 μm.
There is examined a preferable kind of a base material. There are provided test specimens obtained by forming base coating made of silicon oxide and an outermost coating made from a compound containing a fluorinated polysiloxane on a base material with 25 mm (width)×100 mm (length)×1 mm (thickness) as shown in Table 5 according to Example 1. Each of the test specimens is heated to 100° C. with a hot plate and a pig liver piece is placed thereon to evaluate a burning degree. The results are shown in Table 5.
As seen from the results of Table 5, the base coating and outermost coating can be formed irrespectively of the kind of the base material, and the fixation of body tissue can be suppressed. Moreover, stainless steel, titanium or titanium alloy and polyimide, PEEK resin are suitable in consideration with safeness to biological body.
There is examined a preferable example of energy supplied to the operational area portion according to the invention. As an operational area portion of an energy device for surgical operation using microwave, radio-frequency wave, ultrasonic wave or electric energy, a coating layer comprised of a base coating made of silicon oxide and an outermost coating made from a compound containing a fluorinated polysiloxane is formed on a base material and then incision and coagulation of a pig liver are performed to evaluate a burning degree. The results are shown in Table 6.
As seen from the results of Table 6, the fixation of body tissue can be suppressed by forming the base coating made of silicon oxide and the outermost coating made from a compound containing a fluorinated polysiloxane even in any energy devices.
A base coating made of silicon oxide and an outermost coating made from a compound containing a fluorinated polysiloxane are formed on a base material of an operational area portion of a surgical knife, tweezers, forceps or snare used in the surgical operation and thereafter a section structure of each of the coatings is observed to obtain results shown in
Although silicon oxide is used as the base coating in the above examples, results similar to those of the above examples can be obtained even if a mixture containing silicon oxide is used instead of silicon oxide as the base coating. Also, although the compound containing a fluorinated polysiloxane is used as the outermost coating, results similar to those of the above examples can be obtained even if polysiloxane or a mixture containing polysiloxane is used instead of the compound containing a fluorinated polysiloxane.
According to the invention, there can be provided an energy device for surgical operation with coating capable of suppressing fixation of body tissue in an operational area portion of the surgical energy device, which can be preferably used as a surgical knife, tweezers, forceps or snare.
1 electrosurgical knife
2 main body of electrosurgical knife
3 operational area portion
11, 21 base material
12, 23 base coating
13, 24 outermost coating
14 coating layer
22 pretreated portion
| Number | Date | Country | Kind |
|---|---|---|---|
| 2014-201277 | Sep 2014 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2015/070066 | 7/13/2015 | WO | 00 |
