ENERGY DEVICE FOR SURGICAL OPERATIONS

Abstract

There is provided an energy device for surgical operation capable of suppressing fixation of body tissue, wherein a coating layer is formed on an outer periphery of a base material constituting an operational area portion transmitting energy in an energy device for surgical operation operating in the operational area portion, and is comprised of a base coating formed on the base material and an outermost coating formed on the base coating. The base coating is made from silicon oxide or a compound containing silicon oxide, and the outermost coating is made from polysiloxane or a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane, and the coating layer has a good adhesiveness and is applicable to a complicated form.

Claims

1. 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 or a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane.

2. The energy device for surgical operation according to claim 1, wherein a surface roughness of the base material is not more than 3 μm as Ra value before the formation of the base coating.

3. The energy device for surgical operation according to claim 1, wherein a thickness of the base coating is 0.05-10 μm.

4. (canceled)

5. (Cancelled)

6. The energy device for surgical operation according to claim 2, wherein a thickness of the base coating is 0.05-10 μm.

7. The energy device for surgical operation according to claim 1, wherein energy transmitted from the operational area portion to biological tissue is microwave, radio-frequency wave or ultrasonic wave.

8. The energy device for surgical operation according to claim 2, wherein energy transmitted from the operational area portion to biological tissue is microwave, radio-frequency wave or ultrasonic wave.

9. The energy device for surgical operation according to claim 3, wherein energy transmitted from the operational area portion to biological tissue is microwave, radio-frequency wave or ultrasonic wave.

10. The energy device for surgical operation according to claim 6, wherein energy transmitted from the operational area portion to biological tissue is microwave, radio-frequency wave or ultrasonic wave.

11. The energy device for surgical operation according to claim 1, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

12. The energy device for surgical operation according to claim 2, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

13. The energy device for surgical operation according to claim 3, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

14. The energy device for surgical operation according to claim 6, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

15. The energy device for surgical operation according to claim 7, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

16. The energy device for surgical operation according to claim 8, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

17. The energy device for surgical operation according to claim 9, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

18. The energy device for surgical operation according to claim 10, wherein the energy device for surgical operation is a surgical knife, tweezers, forceps or snare.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIGS. 1(a) and (b) are diagrams illustrating a construction of an electrosurgical knife as an example of the energy device for surgical operation according to the invention, respectively.

[0025] FIG. 2 is a sectional view showing a coating layer in a test specimen.

[0026] FIG. 3 is a photomicrograph showing results obtained when a base coating made of silicon oxide and an outermost coating made of a compound containing fluorinated polysiloxane are formed on a base material of an operational area portion in a surgical knife, tweezers, forceps or snare and the sectional structure of each coating is observed by an electron microscope in close-up.

EMBODIMENTS FOR CARRYING OUT THE INVENTION

[0027] FIGS. 1(a) and (b) are diagrams illustrating a construction of an electrosurgical knife as an embodiment of the energy device for surgical operation according to the invention, respectively, wherein FIG. 1(a) is a perspective view of a part thereof and FIG. 1(b) is a sectional view taken along a line A-A in FIG. 1(a). The electrosurgical knife 1 shown in FIG. 1(a) as an example of the invention is constructed with a main body 2 of the electrosurgical knife and an operational area portion 3 protruded from the main body 2.

[0028] 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.

[0029] The feature of the invention lies in a construction of the operational area portion 3 shown in FIGS. 1(a) and (b). In the invention, the operational area portion 3 is constructed with a base material 11 and a coating layer 14 comprised of a base coating 12 disposed on an outer periphery of the base material 11 and an outermost coating 13 disposed on an outer periphery of the base coating 12 as shown in FIG. 1(b), wherein the base coating 12 constituting the coating layer 14 is made from silicon oxide or a compound containing silicon oxide and the outermost coating 13 constituting the coating layer 14 is made from polysiloxane or a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane. In such a construction, fixation of body tissue to the operational area portion can be suppressed by water-repellent and oil-repellent action of the outermost coating having a low surface energy. Also, since the base coating 12 strongly adheres to the base material 11 and the outermost coating 13, good adhesion property is obtained. Furthermore, the base coating 12 can be formed at room temperature or about 150° C., whereby the deformation of the base material 11 due to heat affection can be suppressed.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

EXAMPLES

[0035] There will be described examples in the energy device for surgical operation according to the above embodiments below.

Example 1

[0036] A test specimen having a coating layer shown in FIG. 2 is prepared as a simulation of an operational area portion 3 of an electrosurgical knife 1 as an energy device for surgical operation shown in FIGS. 1(a) and (b). In the example of FIG. 2, a surface of a base material 21 made of SUS 304 steel is subjected to a blast treatment to form a pretreated portion 22 having a surface roughness of Ra: 1 μm. Then, a base coating 23 made of silicon oxide is formed from ethyl silicate (TEOS, for example, made by KOJUNDO Chemical Laboratory Co., Ltd.) at 100° C. Next, an outermost coating 24 made from a compound containing a fluorinated polysiloxane is formed on the base coating 23 by dipping. A test specimen of an invention example is prepared by the above process. As a test specimen of a comparative example are provided a test specimen not forming the base coating 23 and outermost coating 24, and a test specimen not forming the outermost coating 24 in the test specimen of the invention example. A contact angle of water and a contact angle of rapeseed oil are measured with respect to a surface of a coating layer in the test specimens of the invention example and comparative examples. The contact angle is measured by a sessile drop method according to JIS R3257. The results are shown in Table 1.

TABLE-US-00001 TABLE 1 Contact Contact Base Base Outermost angle of angle of Material coating coating water rapeseed oil Remarks SUS304 Absence Absence  35° 10° Comparative steel Example Presence Absence  15°  8° Comparative Example Presence Presence 110° 70° Invention Example

[0037] 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.

Example 2

[0038] 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.

TABLE-US-00002 TABLE 2 Reciprocating number of base coating and base Base Base Outermost Deformation of material exposed by material coating coating base material rubbing test Remarks SUS304 Absence Compound Absence  50 times Comparative steel containing a Example Silicon oxide fluorinated Absence 1000 times Invention polysiloxane Example Iron oxide 0.1 μm Presence  200 times Comparative formed Example through heat treatment (400° C.)

[0039] 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.

Example 3

[0040] 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.

TABLE-US-00003 TABLE 3 Thickness of base Base Base coating Outermost Coagulation Resistance material coating (μm) coating property to burning Remarks SUS304 Silicon 0.01 Compound ◯ X Comparative Example steel oxide 0.05 containing a ◯ Δ Invention Example 0.1 fluorinated ◯ ◯ Invention Example 0.5 polysiloxane ◯ ◯ Invention Example 1.0 0.1 μm ◯ ◯ Invention Example 5.0 Δ ◯ Invention Example 10.0 Δ ◯ Invention Example 15.0 X ◯ Invention Example Note 1) Coagulation property/ ◯ coagulated at 50 W for 30 seconds Δ coagulated at 50 W for 45 seconds X not coagulated at 50 W for 60 seconds Note 2) Resistance to burning/ ◯ no burning Δ removable by wiping X impossible to remove by wiping

[0041] 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.

Example 4

[0042] 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.

TABLE-US-00004 TABLE 4 Surface Base Base Outermost roughness Resistance material coating coating Pretreatment (Ra) to burning Remarks SUS304 Silicon Compound Absence  0.1 μm ◯ Invention Example steel oxide containing a Electrolytic 0.01 μm ◯ Invention Example fluorinated polishing polysiloxane Buffing  0.1 μm ◯ Invention Example 0.1 μm Blast treatment  0.1 μm ◯ Invention Example with spherical  0.5 μm ◯ Invention Example ceramic  1.0 μm ◯ Invention Example abrasive grains  3.0 μm Δ Invention Example  5.0 μm X Comparative Example Blast treatment  0.1 μm ◯ Invention Example with polygonal  0.5 μm ◯ Invention Example ceramic  1.0 μm ◯ Invention Example abrasive grains  3.0 μm Δ Invention Example  5.0 μm X Comparative Example Laser  0.1 μm ◯ Invention Example irradiation  0.5 μm ◯ Invention Example  1.0 μm ◯ Invention Example  3.0 μm Δ Invention Example  5.0 μm X Comparative Example Note ) Resistance to burning/ ◯ no burning Δ removable by wiping X impossible to remove by wiping

[0043] 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.

Example 5

[0044] 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.

TABLE-US-00005 TABLE 5 Judgment of Resistance Base Base Outermost coating to material coating coating formation burning Remarks SUS304 Silicon Compound ∘ ∘ Invention steel oxide containing a Example SUS420J2 fluorinated ∘ ∘ Invention steel polysiloxane Example SS400 steel 0.1 μm ∘ ∘ Invention Example A5052 ∘ ∘ Invention Example A6061 ∘ ∘ Invention Example Pure ∘ ∘ Invention titanium Example Ti-6Al-4V ∘ ∘ Invention Example Polyimide ∘ ∘ Invention Example PEEK ∘ ∘ Invention Example Polycarbonate ∘ ∘ Invention Example Note ) Resistance to burning/ ∘ no burning Δ removable by wiping x impossible to remove by wiping

[0045] 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.

Example 6

[0046] 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.

TABLE-US-00006 TABLE 6 Resistance Base Base Outermost to material coating coating Energy burning Remarks SUS304 Silicon Compound Microwave ∘ Invention steel oxide containing a Example fluorinated Radio- ∘ Invention polysiloxane frequency Example 0.1 μm wave Ultrasonic ∘ Invention wave Example Note ) Resistance to burning/ ∘ no burning Δ removable by wiping x impossible to remove by wiping

[0047] 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.

Example 7

[0048] 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 FIG. 3, As seen from the results of FIG. 3, the base coating made of silicon oxide and the outermost coating made from a compound containing a fluorinated polysiloxane can be formed irrespectively of the form of the operational area portion in the energy device for surgical operation.

[0049] 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.

INDUSTRIAL APPLICABILITY

[0050] 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.

DESCRIPTION OF REFERENCE SYMBOLS

[0051] 1 electrosurgical knife

[0052] 2 main body of electrosurgical knife

[0053] 3 operational area portion

[0054] 11, 21 base material

[0055] 12, 23 base coating

[0056] 13, 24 outermost coating

[0057] 14 coating layer

[0058] 22 pretreated portion