JP6938058B1 - Surgical aid - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a surgical aid that can be used for arthroscopic surgery. SOLUTION: A surgical aid used for abdominal or intrathoracic surgery, the surgical aid includes a compressed body obtained by compressing gauze 21 and a thread 3 for maintaining the shape of the compressed body 2, and performs surgery. A surgical aid having a displacement of 5 mm or less in a three-point bending test when a load of 10 N is applied in the vertical direction with respect to the longitudinal direction L of the aid. [Selection diagram] Fig. 1

Description

The disclosure in this application relates to surgical aids.

In the field of surgery, endoscopic surgery such as laparoscopic surgery and thoracoscopic surgery is rapidly becoming widespread in place of conventional open surgery such as open surgery and thoracotomy. Mirror surgery has various advantages in terms of plastic surgery and minimal invasiveness.

On the other hand, in arthroscopic surgery, there are problems such as tissue damage due to directly grasping and excluding living tissue with forceps for arthroscopic surgery, and difficulty in rapid compression hemostasis at the time of bleeding. Robot-assisted arthroscopic surgery, which has become widespread in recent years, can be expected to be more delicate than conventional arthroscopic surgery by operating forceps with a high degree of freedom utilizing multiple joints. However, even in the case of robot-assisted arthroscopic surgery, there is a problem similar to the above-mentioned arthroscopic surgery.

In arthroscopic surgery, reliable visual field expansion is required regardless of the patient's body shape. Therefore, the present inventors
(1) Roll the medical gauze and tie it with a thread to make a substantially columnar surgical aid.
(2) By grasping the surgical aid with forceps and contacting and pressing the surgical aid against the living tissue,
(3) Secure the field of view while avoiding damage to living tissues.
We are examining the usefulness of the method.

However, the inventors of the present invention
(1) Unlike the arthroscopic surgery in which the operator directly grasps the forceps and uses the surgical aid, in the robot-assisted arthroscopic surgery, the sense of use of the surgical aid is not transmitted to the operator's hand.
(2) Therefore, in robot-assisted arthroscopic surgery, it is necessary to operate the surgical aid based on the visual sense.
(3) However, even if the same surgical aid is usable when the surgeon directly grasps the forceps, it may not be usable in the robot-assisted arthroscopic surgery based on vision.
I discovered a new problem.

The disclosure in this application is made to solve the above problems. After diligent examination, the surgical aid was manufactured so as to have a predetermined strength, so that it could be used in both robot-assisted arthroscopic surgery and arthroscopic surgery in which the operator directly grasps the forceps. I found something new that I could do.

That is, the purpose of the disclosure in this application is to provide a surgical aid that can be used for arthroscopic surgery.

The disclosure in this application relates to the surgical aids shown below.

(1) A surgical aid used for abdominal or intrathoracic surgery.
Compressed gauze and
A thread to maintain the shape of the compressed body,
Including
The amount of displacement in the three-point bending test when a load of 10 N is applied in the vertical direction with respect to the longitudinal direction of the surgical aid is 5 mm or less.
Surgical aid.
(2) The amount of displacement when a compressive load is applied in the lateral direction of the surgical aid is 10% or less at 5N and 15% or less at 10N.
The surgical aid according to (1) above.
(3) The compressed body has a substantially cylindrical shape.
By tying the outer circumference of the substantially cylindrical shape with a thread, the shape of the compressed body is maintained.
The surgical aid according to (1) or (2) above.
(4) A part of the thread penetrates the inside of the compressed body.
The surgical aid according to (3) above.
(5) The length of the surgical aid in the longitudinal direction is 20 mm to 40 mm, and the length in the lateral direction is 5 mm to 12.5 mm.
The surgical aid according to (3) or (4) above.
(6) A surgical aid used for abdominal or intrathoracic surgery.
Compressed gauze and
A thread to maintain the shape of the compressed body,
Including
The thread binds the outer circumference of the compressed body, and a part of the thread penetrates the inside of the compressed body.
Surgical aid.
(7) The compressed body has a substantially cylindrical shape.
The surgical aid according to (6) above.
(8) The length of the surgical aid in the longitudinal direction is 20 mm to 40 mm, and the length in the lateral direction is 5 mm to 12.5 mm.
The surgical aid according to (7) above.

The surgical aids disclosed in this application can be suitably used for arthroscopic surgery.

FIG. 1A is a schematic perspective view of the surgical aid 1a according to the first embodiment, and FIG. 1B is a schematic side view of the surgical aid 1a as viewed from the Z-axis direction. FIG. 2 is a diagram illustrating an outline of a three-point bending test of the surgical aid according to the first embodiment. FIG. 3 is a diagram illustrating an outline of a test method (compressive load) according to a modified example of the surgical aid according to the first embodiment. 4A is a schematic perspective view of the surgical aid 1b according to the second embodiment, and FIGS. 4B to 4D are schematic cross-sectional views of the surgical aid 1b in the XX'direction. FIG. 5 is a drawing substitute photograph, which is a photograph of the surgical aid prepared in Example 1. FIG. 6 is a graph showing the results of a three-point bending test. FIG. 7 is a graph showing the results of the compression test. FIG. 8A is a drawing-substituting photograph, which is a photograph when the surgical aid of Example 1 is grasped with the left hand forceps and the rectal left anterior wall is peeled off with the right hand forceps. FIG. 8B is a drawing substitute photograph, which is a photograph when the surgical aid of Example 1 is grasped with the left hand forceps and the rectal right anterior wall is peeled off with the right hand forceps.

The surgical aids disclosed in this application will be described in detail below. The position, size, range, etc. of each configuration shown in the drawings may not represent the actual position, size, range, etc. for easy understanding. Therefore, the disclosure of this application is not necessarily limited to the position, size, range, etc. disclosed in the drawings.

In addition, in this specification,
(1) The numerical range represented by using "~" means a range including the numerical values before and after "~" as the lower limit value and the upper limit value.
(2) For numerical values, numerical ranges, and qualitative expressions (for example, expressions such as "same" and "same"), the numerical values, numerical ranges, and properties including errors generally allowed in the technical field are used. Showing,
(3) When described as "approximately XX shape", in addition to the accurate XX shape, it includes a shape that can be grasped as approximately XX shape.
Is interpreted as.

(Definition of direction)
The appearance of the surgical aid 1 is substantially columnar. In the present specification, the "longitudinal direction (L)" means a direction in which the distance of the substantially columnar shape is long, and the "short direction (S)" means a direction in which the distance of the substantially columnar shape is short. Further, in the present specification, a substantially central axis having a substantially columnar shape is defined as a Z axis. The Z-axis direction and the longitudinal direction L are substantially parallel.

(First Embodiment of Surgical Aid)
The surgical aid 1a according to the first embodiment will be described with reference to FIG. FIG. 1A is a schematic perspective view of the surgical aid 1a, and FIG. 1B is a schematic side view of the surgical aid 1a as viewed from the Z-axis direction.

The surgical aid 1a according to the first embodiment includes a compressed body 2 in which the gauze 21 is compressed, and a thread 3 for maintaining the shape of the compressed body 2. When a load of 10 N is applied in the vertical direction with respect to the longitudinal direction L of the surgical aid 1a, the displacement amount by the three-point bending test is 5 mm or less.

The compressed body 2 is produced by compressing the gauze 21. As the gauze 21, general sterile gauze used in surgery may be used. For example, Trox (registered trademark) (manufactured by Osaki Medical Co., Ltd.) and the like can be mentioned.

Although the gauze 21 contains a relatively large space (gap), as shown in Examples and Comparative Examples described later, the surgical aid 1a disclosed in the present application needs to have a predetermined strength. Therefore, the compressed body 2 is made densely while compressing the gauze 21 to increase the strength. FIGS. 1A and 1B show an example in which a substantially rectangular gauze 21 is tightly wound while applying pressure in a spiral shape from the end. There is no limitation on the production method of 2. Alternatively, the substantially rectangular gauze may be folded in two, three, four, or the like a predetermined number of times and then rolled up in a spiral shape to form the compressed body 2.

Examples of the shape of the compressed body 2 (surgical assisting tool 1a) include a substantially cylindrical shape, a substantially elliptical column shape, a substantially prismatic shape, and the like, but a substantially cylindrical shape is preferable from the viewpoint of operability and ease of manufacture.

The compressed body 2 is preferably made of gauze 21. By producing with gauze 21, fine irregularities are formed around the compressed body 2 due to the gaps between the fibers constituting the gauze 21. Therefore, when the surgical aid 1a comes into contact with the tissue, friction is generated between the compressed body 2 and the living tissue. Therefore, when the surgical auxiliary tool 1a presses the living tissue, the compressed body 2 and the living body It slips between the tissue and becomes worse. As a result, as compared with the case where the visual field is secured while grasping the biological tissue with forceps or the like, the biological tissue can be moved and the visual field can be secured while avoiding damage to the biological tissue. Further, the compressed body 2 is originally a gauze 21 having many gaps although it is compressed. Therefore, at the time of surgery, the compressed body 2 (surgical assisting tool 1a) can also suck blood, fat, and the like.

The thread 3 is used to retain the shape of the compressed body 2. The type of thread 3 is not particularly limited, but a thread generally used in surgery is preferable in consideration of safety to a living body. Examples of the thread 3 include, but are not limited to, a polygrantin suture (3-0 Vicryl, etc.), a surgical silk thread (3-0 silk thread, etc.), and the like.

The thread 3 is not particularly limited in how it is tied as long as it can retain the shape of the compressed body 2. FIG. 1A shows an example in which the outer circumference of the compressed body 2 is bound by the thread 3 in a direction substantially parallel to the rotation direction R of the gauze 21. In FIG. 1A, an example is described in which the thread 3 binds the compressed body 2 at three places, but the surgical aid 1a is predetermined at the places where the thread 3 is tied by holding the shape of the compressed body 2. There is no particular limitation as long as the strength can be maintained. For example, the compressive body 2 may be tied at four or five places, and the surgical aid 1a may be appropriately adjusted within a range that can maintain a predetermined strength.

The distance between the threads 3 and the threads 3 varies depending on the number of places where the threads 3 are bound, but may be provided at positions symmetrical with respect to the center of the compressed body 2. Further, at the time of surgery, blood, fat and the like are sucked from the side surfaces of both ends of the compressed body 2. Therefore, as compared with the central portion of the compressed body 2, both end portions are more likely to swell due to blood, fat, etc. sucked during the operation, and may be difficult to remove from the trocar. Therefore, by tying the portion of the compressed body 2 relatively close to the end portion with the thread 3, it may be possible to make it difficult for both end portions of the compressed body 2 to swell. If the portion where the thread 3 is bound is too close to both ends of the compressed body 2, the bound thread 3 is likely to fall off from the end portion. Therefore, the portion where the thread 3 is bound may be appropriately adjusted so that the bound thread 3 does not easily fall off and is close to both ends. For example, about 3 mm to 5 mm from both ends of the compressed body 2. The position can be mentioned.

Further, at each position where the thread 3 is bound, the thread 3 may be tied after the outer circumference of the compressed body 2 is wound in a single layer to form a knot 31. Alternatively, after winding the outer circumference of the compressed body 2 a plurality of times, such as double or triple, the thread 3 may be tied to form the knot 31.

In the example shown in FIG. 1A, the compressed body 2 is formed by winding the gauze 21 precisely. Therefore, since the strength of the compressed body 2 itself is already high, the portion where the thread 3 is bound is not easily crushed in the Z-axis direction.

Alternatively, the degree of compression when winding the gauze 21 is slightly lowered, and the produced compression body 2 is strongly tied with the thread 3 in the Z-axis direction to increase the strength of the compression body 2 (surgical aid 1a). You may. In this case, the compressed body 2 at the portion where the thread 3 is tightly bound is slightly crushed in the Z-axis direction, but is within a range that does not affect the operability when grasping with forceps or pressing the living tissue. There is no particular problem. When the compressive strength of the compressed body 2 itself is increased, the manufacturing cost may increase. The compressive strength of the compressed body 2 itself may be appropriately adjusted while considering the manufacturing cost and operability.

As described above, when the term "compressed body" is used in the present specification, in addition to the molded body of gauze 21 compressed to a predetermined strength even in the absence of the thread 3, the molded body of the gauze 21 is bound by the thread 3. It also means a molded body whose strength has been increased as a result of compression. Further, in the present specification, the thread 3 may have a function of increasing the compressive strength of the molded body of the gauze 21 in addition to the function of maintaining the shape of the compressed body 2.

During the arthroscopic surgery, the surgical aid 1a is inserted into the body through the trocar. Therefore, the size of the surgical aid 1a is not particularly limited as long as it can pass through the trocar, and may be appropriately adjusted according to the place to be operated and the like. For example, the longitudinal direction L of the surgical aid 1a is preferably about 20 mm to 40 mm, more preferably about 25 mm to 35 mm, further preferably about 27.5 mm to 32.5 mm, and particularly preferably about 30 mm. The size in the lateral direction is preferably about 5 mm to 12.5 mm, more preferably about 9 mm to 11 mm, and even more preferably about 10 mm. The size in the lateral direction means the diameter when the surgical aid 1a has a substantially cylindrical shape, but when the surgical aid 1a has a shape other than the substantially cylindrical shape, when the lateral direction is sandwiched between substantially parallel virtual lines. In addition, it means the longest distance. For example, when the surgical aid 1a has a substantially elliptical column shape, the lateral direction means the long axis of the ellipse.

As described above, in the compressed body 2 constituting the surgical aid 1a, the portion where the thread 3 is strongly bound may be slightly crushed in the Z-axis direction. In that case, the size in the lateral direction means the distance that becomes the longest when the lateral direction is sandwiched between substantially parallel virtual lines, in other words, the distance of the raised portion that is not bound by the thread 3. Further, as for the size of the longitudinal direction L, since the compressed body 2 is formed by winding the gauze 21, both ends of the longitudinal direction L may not be flat. Therefore, the size of the longitudinal direction L may be the length of the side corresponding to the longitudinal direction L of the substantially rectangular gauze 21 before forming the compressed body 2.

Next, the three-point bending test in the present specification will be described with reference to FIG. The three-point bending test in the present specification is performed using the pedestal 4 and the indenter 5. The surface 4a of the pedestal 4 is substantially flat, and a gap 4b of 15 mm is formed on the surface 4a of the pedestal 4. The pedestal 4 and the indenter 5 are arranged so that the tip of the indenter 5 is at the center of the gap 4b. The surgical aid 1a is placed on the surface 4a of the pedestal 4 so that the longitudinal directions L are substantially parallel to each other. Then, the indenter 5 is moved in the vertical direction G with respect to the longitudinal direction L of the surgical aid 1a. In the present specification, the displacement amount by the three-point bending test is the displacement amount of the indenter 5 when the measured value of the measuring device shows 10N from the position where the tip of the indenter 5 abuts on the surgical aid 1a (load 0N). It means the amount of displacement in the vertical direction G.

When a load of 10 N is applied in the vertical direction with respect to the longitudinal direction of the surgical aid 1a, the displacement amount by the three-point bending test is preferably 5 mm or less. When the displacement amount is larger than 5 mm, the surgical aid 1a is easily bent. Therefore, when the surgical assist tool 1a is grasped by forceps and crimped to the living tissue and the living tissue is moved with a large force, the surgical assisting tool 1a is easily bent due to the frictional force with the living tissue, which is not desirable.

If the displacement amount is 5 mm or less, the function of the surgical aid 1a is not particularly limited. However, in order to make the displacement amount very small, it is necessary to wind the gauze 21 very precisely, tie the thread 3 strongly, and / or increase the number of places where the thread 3 is tied, which increases the manufacturing cost. It gets higher. Therefore, the winding of the gauze 21, the binding strength of the thread 3, and / or the number of places where the thread 3 is bound may be adjusted so that the displacement amount becomes a desired value while considering the manufacturing cost and the like.

Even when the displacement is larger than 5 mm, when the surgeon directly grasps the forceps and uses the surgical aid 1a, the feeling of operating the surgical aid 1a in the operator's hand is in addition to the visual sense. Is transmitted. Therefore, even when the displacement amount is larger than 5 mm, it is possible to prevent the surgical assisting tool 1a from bending by moving the surgical assisting tool 1a while adjusting the pressing force on the living tissue. However, in the robot-assisted arthroscopic surgery, since the surgical assist tool 1a is operated based on the visual sense, the operator's hand does not feel the operation of the surgical assist tool 1a. The surgical aid 1a according to the first embodiment has a displacement amount of 5 mm or less in a three-point bending test when a load of 10 N is applied in the vertical direction with respect to the longitudinal direction, thereby performing robot-assisted arthroscopic surgery and surgery. In any case of arthroscopic surgery in which a person directly grips the forceps, the surgical aid 1a can be used without bending.

(Modified example of the first embodiment of the surgical aid)
Next, a modified example of the first embodiment of the surgical aid 1a will be described. The surgical assist tool 1a according to the modified example is the operation according to the first embodiment except that it is specified by the displacement amount of the surgical assist tool 1a when a compressive load is applied in the lateral direction instead of the three-point bending test. It is the same as the auxiliary tool 1a. Therefore, in the modified example, the difference in the test method will be mainly described, and the repetitive description of the matters explained in the first embodiment will be omitted. Therefore, it goes without saying that the matters explained in the first embodiment can be adopted even if they are not explicitly explained in the modified example.

A test method according to a modified example will be described with reference to FIG. In the modified example, the experimental method of the first embodiment of the surgical aid 1a is the same except that the pedestal 41 having a substantially flat surface 41a having no gap 4b is used instead of the pedestal 4 having the gap 4b. be. By using the pedestal 41 having no gap 4b, the displacement amount of the indenter 5 when the surgical aid 1a is compressed by the indenter 5 and the pedestal 41 is measured.

Unlike arthroscopic surgery, robot-assisted arthroscopic surgery does not convey the sensation of using surgical aids to the operator's hands. In the first embodiment of the surgical aid 1a, the preferable strength of the surgical aid 1a is specified by a three-point bending test from the viewpoint that the frictional force between the surgical aid 1a and the biological tissue is not transmitted to the operator's hand. bottom. On the other hand, in the modified example, in the robot-assisted arthroscopic surgery, even if the operator grasps the forceps operation handle of the robot, the feeling of actually grasping the surgical aid 1a with the forceps (repulsive force of the surgical aid 1a) is felt. I can't get it. Therefore, in the actual operation, as a result of strongly grasping the forceps operation handle of the robot, the forceps may crush the surgical aid 1a. Therefore, in the modified example, the preferable strength of the surgical aid 1a was specified by the compression test from the viewpoint that the repulsive force of the surgical aid 1a is not transmitted to the operator's hand when the surgical aid 1a is gripped with forceps. ..

In the modified example, the amount of displacement of the surgical aid 1a when a compressive load is applied in the lateral direction is 1 mm or less at 5N and 1.5 mm or less at 10N. It is said that the gripping force of the forceps when the operator directly grips the forceps is about 5N, and in the case of the robot-assisted surgery device, the maximum value of the gripping force is about 10N, although it varies depending on the device. The amount of displacement when the above compressive loads of 5N and 10N are applied makes it possible to handle the surgical aid 1a in both robot-assisted arthroscopic surgery and arthroscopic surgery in which the operator directly grasps the forceps. There is no problem.

The amount of displacement when a compressive load is applied in the lateral direction may differ depending on the length in the lateral direction even when the same compressive load is applied. As described later, the length of the surgical aid 1a produced in the example in the lateral direction was about 10 mm. Therefore, regarding the compressive load,
(Measured displacement) / (Length in the lateral direction) x 100 (%)
It may be specified by. In that case, the displacement amount at 5N may be 10% or less, and the displacement amount at 10N may be 15% or less.

Similar to the surgical aid 1a according to the first embodiment, the surgical aid 1a according to the modified example adjusts the winding of the gauze 21, the binding strength of the thread 3, and / or the number of places where the thread 3 is bound. Therefore, the compressive strength can be adjusted. The strength of the surgical aid 1a may be specified only by the compressive strength shown in the modified example, may be specified by the three-point bending strength shown in the first embodiment, or may be specified by the compressive strength and the three-point bending strength. It may be specified.

(Second Embodiment of Surgical Aid)
The surgical aid 1b according to the second embodiment will be described with reference to FIG. 4A is a schematic perspective view of the surgical aid 1b, and FIGS. 4B to 4D are schematic cross-sectional views of the surgical aid 1b in the XX'direction. The gauze 21 is formed in a spiral shape in the cross section in the XX'direction. However, in FIGS. 4B to 4D, in order to make it easy to understand the arrangement of the threads 3, the illustration of the spiral in the cross-sectional view of the compressed body 2 is omitted and is simply described.

The surgical aid 1b according to the second embodiment is different from the surgical aid 1a and its modifications according to the first embodiment in that a part of the thread 3 penetrates the inside of the compressed body 2. , Other points are the same as the surgical aid 1a and its modified example according to the first embodiment. Therefore, in the surgical aid 1b according to the second embodiment, the relationship between the compressed body 2 and the thread 3 will be mainly described, and the repetitive explanation of the matters explained in the first embodiment and the modified example will be described. Omit. Therefore, it goes without saying that the matters explained in the first embodiment and the modified examples can be adopted even if they are not explicitly explained in the second embodiment.

The surgical aid 1b according to the second embodiment is not particularly limited as long as a part of the thread 3 that binds the compression body 2 penetrates the inside of the compression body 2. An example of penetration will be described with reference to FIGS. 4B to 4D.

First, a knot 31 is formed at one end of the thread 3. Then, the other end of the thread 3 is passed through a needle (not shown). The thread 3 that penetrates the compressed body 2 at the same time may be one thread (the ends of the thread 3 are not tied to each other) or two threads (after passing the thread 3 through the needle, the knot 31 is formed at both ends of the thread 3). Is formed). Then, the needle is penetrated in the lateral direction of the compressed body 2 so as to penetrate the laminated gauze 21. The place where the thread 3 is penetrated is not particularly limited, but when molding the surgical aid 1b having a substantially cylindrical shape, it is desirable to penetrate the thread 3 so as to cross the central axis Z (see FIG. 4B).

The thread 3 penetrating the compression body 2 is tightly wound around the outer circumference of the compression body 2 (see FIG. 4C. The thread 3 is described separately from the compression body 2 for ease of understanding). The number of times the outer circumference of the compressor 2 is wound with the thread 3 is not particularly limited. It may be adjusted as appropriate, such as once, twice, three times, four times, and the like. Further, when winding a plurality of times, the threads 3 may be wound so as to overlap each other, or may be wound while being slightly shifted.

After winding the thread 3 a predetermined number of times, the thread 3 is pierced through the compressed body 2 again with a needle. After penetrating, a knot 31 is formed on the thread 3 on the other end side (see FIG. 4D). In the example shown in FIG. 4D, the knot 31 on one end side and the knot 31 on the other end side of the thread 3 are formed in opposite directions, but the position where the knot 31 is formed is not particularly limited. The knot 31 on one end side and the other end side of the thread 3 may be at substantially the same position.

In the surgical aid 1b shown in FIG. 4A, the thread 3 is wound at three points. The example of penetrating the compressed body 2 shown in FIGS. 4B to 4D with the thread 3 may be carried out at only one place, or may be carried out at all places where the thread 3 is wound.

The surgical aid 1b according to the second embodiment has the following effects in addition to the effects of the surgical aid 1a according to the first embodiment.
(1) In the case of the surgical aid 1a according to the first embodiment, it is necessary to tie one end and the other end of the thread 3, but the knot 31 of the thread 3 is easily untied. On the other hand, in the surgical aid 1b according to the second embodiment, since it is not necessary to tie one end and the other end of the thread 3, the thread is hard to loosen. Therefore, when the surgical assisting tool 1 is loaded during the operation, the surgical assisting tool 1b according to the second embodiment has less loosening of the thread 3, and the shape of the surgical assisting tool 1b can be easily maintained. Therefore, the amount of the surgical aid 1b used in one operation is reduced.
(2) In the case of the surgical aid 1a according to the first embodiment, the thread 3 may be unwound and fall off from the compressed body 2 during the operation. In that case, it is necessary to grab and remove the thread 3 that has fallen off with forceps. On the other hand, in the surgical aid 1b according to the second embodiment, since the thread 3 penetrates the compressed body 2, the thread 3 is unlikely to fall off from the compressed body 2 even if the thread is unwound. Therefore, the labor of removing the unraveled thread 3 with forceps can be saved, and the risk of misplacement in the living body is reduced.

In the surgical aid 1b according to the second embodiment, the gauze 21 is wound up, the binding strength of the thread 3 and / or the thread is similar to the surgical assist tool 1a and the modified example according to the first embodiment. By adjusting the number of points that bind the three, the three-point bending strength and the compressive strength can be adjusted.

The embodiments disclosed in the present application will be specifically described below with reference to examples, but the embodiments are merely for the purpose of explaining the embodiments. It does not represent limiting or limiting the scope of the invention disclosed in this application.

[Making surgical aids]
<Example 1>
(material)
-Gauze: Trox A type (30 mm x 150 mm, product number 23700, manufactured by Osaki Medical Co., Ltd.) was used as it was.
・ Thread: Surgical silk thread

(Manufacturing procedure)
(1) With the contrast thread of the gauze on the outside, the gauze was rolled up while rolling hard from the end of 30 mm to form a compressed body.
(2) A knot was made by passing the thread through a needle and fixing both ends of the thread together. In addition, in order to make the knot larger, the ball stopper was doubled.
(3) The needle was pierced so as to pass through the center of the compressed body. As described in (2), since both ends of the thread were ball-stopped, the compressed body was simultaneously penetrated by the two threads.
(4) After penetrating the compressed body, the outer circumference of the compressed body was tightly wound twice with a thread. After that, the needle was pierced once again so as to pass through the center of the compressed body, and after the piercing, the thread was double-balled to prevent the thread from coming off.
(5) The surgical aid of Example 1 was prepared by performing the procedure described in (2) to (4) above at a total of three locations 5 mm from the center and both ends of the compressed body.

FIG. 5 is a photograph of the surgical aid produced in Example 1. The surgical aid produced in Example 1 had a substantially cylindrical shape, and had a length of about 30 mm in the longitudinal direction and a length of about 10 mm in the lateral direction.

<Comparative example 1>
The surgical aid of Comparative Example 1 was prepared in the same procedure as in Example 1 except for the changes described below.
(1) The thread was not penetrated through the compressed body, and the outer circumference of the compressed body was wound twice with the thread, and then the thread was tied.
(2) There were two places to tie the thread (about 7.5 mm from both ends).

[3-point bending test]
A tensile tester (EZ-Test, manufactured by SHIMAZU) was used as the measuring device. The pedestal used had a gap of 15 mm. As shown in FIG. 2, the surgical aids produced in Example 1 and Comparative Example 1 were arranged so that the indenter 5 was in contact with the center of the surgical aid, and the change in displacement was measured. FIG. 6 shows the results of the three-point bending test. The displacement amount by the three-point bending test when a load of 10 N was applied in the vertical direction with respect to the longitudinal direction of the produced surgical aid was 4.27 mm in Example 1 and 13.32 mm in Comparative Example 1.

[Compression test]
A tensile tester (EZ-Test, manufactured by SHIMAZU) was used as the measuring device. The pedestal used had a flat surface. As shown in FIG. 3, the surgical aids produced in Example 1 and Comparative Example 1 were arranged so that the indenter 5 was in contact with the center of the surgical aid, and the change in displacement was measured. FIG. 7 shows the results of the compression test. The amount of displacement of the produced surgical aid when a compressive load was applied in the lateral direction was as follows.

<Displacement amount of Example 1>
5N: 0.83 mm (8.3%)
10N: 1.12mm (11.2%)
<Displacement amount of Comparative Example 1>
5N: 2.18mm (21.8%)
10N: 2.69mm (26.9%)

[Robot-assisted arthroscopic surgery]
Using the surgical aids prepared in Example 1 and Comparative Example 1, rectal cancer surgery was performed under the support of a da Vinci Surgical System manufactured by Intuitive Surgical. FIG. 8A is a photograph of the surgical aid of Example 1 being grasped with the left hand forceps and the rectal left anterior wall peeling operation being performed with the right hand forceps. FIG. 8B is a photograph of the surgical aid of Example 1 being grasped with the left hand forceps and the right anterior wall of the rectum being peeled off with the right hand forceps. When the surgical aid prepared in Example 1 was used, the surgical aid could proceed without any problem without bending even if it contacted or pressed against the living tissue when securing the visual field. On the other hand, in the operation using the surgical aid prepared in Comparative Example 1, the surgical aid may bend when it comes into contact with or presses against the living tissue.

In the arthroscopic surgery using the surgical aid prepared in Comparative Example 1 in which the surgeon directly grasps the forceps and uses the surgical aid, although there is an inconvenience that the surgical aid is easily bent, it is visually and tactile. As a result, the surgeon was able to correct the operation of the surgical aid, which was less inconvenient than the robot-assisted arthroscopic surgery.

From the above results, it is clear that in robot-assisted arthroscopic surgery, unlike arthroscopic surgery in which the operator directly grasps the forceps and uses the surgical aid, the surgical aid needs to have a predetermined strength. It became.

Further, in the case of robot-assisted arthroscopic surgery using the surgical aid prepared in Example 1, the number of surgical aids used per rectal cancer surgery was two. On the other hand, the number of surgical aids used in Comparative Example 1 was five. The reason is
(1) The surgical aid of Comparative Example 1 had two places where the thread was wound, and the three-point bending strength was weak. As a result, the surgical aid was deformed during the operation, and as a result, the knot was loosened and the shape was liable to collapse.
(2) The surgical aid of Comparative Example 1 is more likely to be crushed in the lateral direction than the surgical aid of Example 1. Therefore, when the surgical aid of Comparative Example 1 was grasped with forceps near the thread, the frictional force between the thread and the compressed body was smaller, and as a result, the shape of the surgical aid was more likely to collapse.
(3) The surgical aid of Comparative Example 1 merely winds the outer circumference of the compressed body with a thread. In other words, the compressor and thread can move relative to each other when pressure is applied to the surgical aid. On the other hand, in the surgical aid of Example 1, a part of the thread penetrates the compressed body 2, and the penetrating thread has an invariant position relative to the compressed body 2. Therefore, even if pressure is applied to the surgical aid of Example 1, it is difficult for the compressed body and the thread to move relative to each other.
(4) The surgical aid of Comparative Example 1 exerts only a tightening force from the outside to the center of the surgical aid by binding the outer circumference of the compressed body with a thread. In other words, the thread on the outer circumference of the compressed body tightens the entire cross-sectional area of the compressed body. On the other hand, in the surgical aid of Example 1, a part of the thread penetrates the compressed body 2. Therefore, in the surgical aid of the first embodiment, the compressed body can be tightened by the thread whose relative position inside the compressed body does not change and the thread on the outer periphery of the compressed body. In other words, in the first embodiment, the cross-sectional area of the compressed body can be divided and tied with a thread. Therefore, when pressure is applied to the surgical aid, the pressure can be finely dispersed in the first embodiment, so that the force related to the knot of the thread is dispersed, and as a result, it is easy to maintain the shape of the surgical aid.
(5) The synergistic effect of (1) to (4) above.
Can be considered.

The surgical aids disclosed in this application can be used in both robot-assisted arthroscopic surgery and arthroscopic surgery in which the operator directly grasps the forceps. Therefore, it is useful for the medical device manufacturing industry.

1, 1a ... Surgical aid, 2 ... Compressor, 21 ... Gauze, 3 ... Thread, 31 ... Knot, 4 ... Pedestal, 4a ... Surface, 4b ... Gap, 5 ... Indenter, G ... Indenter movement direction, L ... Longitudinal direction, R ... Gauze rotation direction, S ... Short direction, Z ... Approximately columnar central axis

Claims (7)

A surgical aid used for abdominal or intrathoracic surgery.
Compressed gauze and
A thread to maintain the shape of the compressed body,
Including
The thread binds the outer circumference of the compressed body, and a part of the thread binding the outer circumference penetrates the compressed body in the lateral direction .
The amount of displacement in the three-point bending test when a load of 10 N is applied in the vertical direction with respect to the longitudinal direction of the surgical aid is 5 mm or less.
Surgical aid. The amount of displacement when a compressive load is applied in the lateral direction of the surgical aid is 10% or less at 5N and 15% or less at 10N.
The surgical aid according to claim 1. The compressed body has a substantially cylindrical shape,
By tying the outer circumference of the substantially cylindrical shape with a thread, the shape of the compressed body is maintained.
The surgical aid according to claim 1 or 2. The length of the surgical aid in the longitudinal direction is 20 mm to 40 mm, and the length in the lateral direction is 5 mm to 12.5 mm.
The surgical aid according to claim 2 or 3. A surgical aid used for abdominal or intrathoracic surgery.
Compressed gauze and
A thread to maintain the shape of the compressed body,
Including
The thread binds the outer circumference of the compressed body, and a part of the thread binding the outer circumference penetrates the compressed body in the lateral direction.
Surgical aid. The compressed body has a substantially cylindrical shape,
The surgical aid according to claim 5. The length of the surgical aid in the longitudinal direction is 20 mm to 40 mm, and the length in the lateral direction is 5 mm to 12.5 mm.
The surgical aid according to claim 6.

Images