JP6617896B1 - Colposcope - Google Patents

Abstract

An object of the present invention is to reduce the pain felt by a subject when the vaginal opening is widened while securing the strength of the entire colposcope. A speculum has a main body and a cover member. The main body 10 is made of a hard resin, and has an upper beak 11 and a lower beak 12 that rotate relatively. The cover member 20 covers the outer peripheral surface 11P and the outer peripheral surface 12P of the vaginal opening insertion region R in the upper beak portion 11 and the lower beak portion 12. The cover member 20 is made of a resin softer than the main body 10. [Selection diagram] FIG.

Description

  The present invention relates to a colposcope.

  Conventionally, a colposcope has been used by doctors in the examination of a patient and a subject to be examined (hereinafter referred to as a subject) in the vaginal cavity. With the colposcope inserted into the subject's vaginal opening, the vaginal speculum (upper and lower hips) is opened and the vaginal opening in contact with the vaginal opening is widened, allowing the doctor to examine the vaginal cavity. It becomes possible to do.

  Conventionally, in order to repeatedly use a colposcope as a medical instrument, a metal colposcope that can be sterilized and sterilized has been mainly used. However, a metal colposcope is likely to give fear to the subject because a metal sound is generated during use. For this reason, resin colposcopes are often used in recent years. A resinous colposcope is disclosed in Patent Document 1, for example.

Japanese Utility Model Publication No. 4-47403

  By the way, although there are individual differences depending on age and whether or not childbirth is experienced, many subjects feel pain when the vaginal opening is widened. In order to relieve the pain felt by the subject as much as possible, it may be desirable to form the entire colposcope with a soft material. However, in order to relatively rotate the upper and lower buttocks of the colposcope to widen the vaginal opening, the upper and lower buttocks and the main body that supports these can be rotated. It is necessary to secure. If the entire colposcope is too soft, it is difficult to ensure the above strength.

  Conventional resin-made colposcopes are made of high-hardness resin (hard resin) to ensure strength, and it is difficult to reduce the pain felt by the subject when the vaginal opening is widened. It was. Therefore, it is desired to develop a colposcope that can reduce the pain felt by the subject when the vaginal opening is widened while ensuring the required strength, but such a colposcope has not been realized yet.

  The present invention has been made to solve the above problems, and its purpose is to reduce the pain felt by the subject when the vaginal opening is widened while ensuring the strength of the entire colposcope. The purpose is to provide a colposcope.

  A colposcope according to one aspect of the present invention is a colposcope including a main body having an upper collar part and a lower collar part that are made of a hard resin and relatively rotate, and the upper collar part and the lower collar part. A cover member that covers the outer peripheral surface of the vaginal opening insertion region, and the cover member is made of a softer resin than the main body.

  The cover member is preferably made of a rubber material.

  The hardness of the main body is preferably 85 or more and 120 or less on the R scale of Rockwell hardness.

  The cover member preferably has a Shore hardness Hs of 10 or more and 100 or less.

  The upper collar part and the lower collar part preferably each have a through-hole penetrating in the thickness direction.

  It is desirable that the cover member continuously cover the inner peripheral surface in addition to the outer peripheral surface in the vaginal opening insertion region of the upper and lower collar portions.

  The cover member preferably includes an upper cover member that covers an outer peripheral surface of the upper collar portion and a lower cover member that covers an outer peripheral surface of the lower collar portion.

  When the rotation axis direction when the upper collar part and the lower collar part rotate relatively is the X direction, the upper cover member and the lower cover member are the upper collar part and the lower collar part, respectively. In the closed state, the outermost end portion in the X direction of the upper cover member is preferably formed in a shape that contacts the outermost end portion in the X direction of the lower cover member.

  In the state where the upper collar part and the lower collar part are closed, the amount of protrusion in the X direction of the upper cover member and the lower cover member from the upper collar part and the lower collar part is X1 (mm), respectively. In this case, the protrusion amount X1 is desirably 2 mm or more and 4 mm or less.

  In a state in which the upper collar part and the lower collar part are closed, the upper collar part and the lower collar part are perpendicular to the direction in which the upper collar part and the lower collar part face each other, and the rotation axis direction of the upper collar part and the lower collar part When the direction perpendicular to the Y direction is the Y direction, the upper cover member and the lower cover member have a rotation axis in the Y direction of the upper cover member in a state where the upper and lower collar portions are closed. It is desirable that the opposite end is formed in a shape that comes into contact with the opposite end of the lower cover member in the Y direction from the rotation axis.

  In the state where the upper collar part and the lower collar part are closed, the amount of protrusion in the Y direction of the upper cover member and the lower cover member from the upper collar part and the lower collar part is Y1 (mm), respectively. In this case, the protrusion Y1 is desirably 8 mm or more and 17 mm or less.

  When the rotation axis direction when the upper collar part and the lower collar part rotate relatively is the X direction, the cover member has a cover recess part that is recessed inward in the X direction. Is desirable.

  It is desirable that the upper collar part and the lower collar part each have a body dent part recessed inward in the X direction, and the cover dent part is positioned along each of the body dent parts.

  When the maximum width in the X direction of the cover member is W (mm) and the amount of depression in the X direction of the cover depression is X2 (mm), the amount of depression X2 is 0.02 W or more and 0.1 W or less. It is desirable to be.

  According to said structure, the main body which has an upper collar part and a lower collar part consists of hard resin. Thereby, the intensity | strength of the whole colposcope can be ensured. Moreover, since the outer peripheral surface of the vaginal opening insertion region of the upper and lower buttocks is covered with a cover member that is softer than the main body, the upper and lower buttocks are inserted into the vaginal opening and rotated relatively. When the vaginal opening is widened, the cover member is deformed by contact with the vaginal opening. The deformation of the cover member can reduce the pain felt by the subject when the vaginal opening is widened.

It is a perspective view in the state where the eyelid of the colposcope concerning one embodiment of the present invention opened. It is a side view in the state where the eyelid of the above-mentioned colposcope was opened. It is a side view in the state where the eyelid of the above-mentioned colposcope was closed. It is a perspective view of the said colposcope in the state which abbreviate | omitted illustration of the cover member. It is sectional drawing when the said colposcope is cut | disconnected by the YZ surface. It is sectional drawing when the colposcope of FIG. 5 is cut | disconnected by the ZX surface containing an AA line. It is sectional drawing when the colposcope of FIG. 5 is cut | disconnected by the ZX surface containing a BB line. It is sectional drawing which shows the modification of the upper side cover member and lower side cover member which comprise the said cover member. It is sectional drawing which shows the other modification of the said upper side cover member and the said lower side cover member. It is a perspective view of the colposcope which concerns on other embodiment of this invention. It is a top view of the said colposcope. It is explanatory drawing which shows the hollow amount of the X direction of the cover hollow part of the cover member of the said colposcope. It is sectional drawing which shows the other structure of the said colposcope.

<Embodiment 1>
An embodiment of the present invention will be described below with reference to the drawings.

(Outline of the colposcope)
FIG. 1 is a perspective view of the colposcope 1 of this embodiment, and FIG. 2 is a side view of the colposcope 1. 1 and 2 show a perspective view and a side view, respectively, in a state in which the fold of the colposcope 1 is opened. FIG. 3 is a side view of the colposcope 1 in a closed state. The colposcope 1 includes a main body 10 and a cover member 20. FIG. 4 is a perspective view of the colposcope 1 with the cover member 20 not shown. The main body 10 includes an upper collar part 11, a lower collar part 12, a support part 13, and a grip part 14. The upper collar portion 11 and the lower collar portion 12 constitute the above collar. Details of the cover member 20 will be described later.

  For convenience of explanation, directions are defined as follows. As shown in FIG. 3, the opposing direction of the upper collar part 11 and the lower collar part 12 in the state in which the upper collar part 11 and the lower collar part 12 are closed is the vertical direction, and this is the Z direction. At this time, in the facing direction, the direction from the lower collar 12 to the upper collar 11 is defined as upward (positive in the Z direction), and the direction from the upper collar 11 to the lower collar 12 is defined as negative (negative in the Z direction). And Further, the direction of the rotation axis that is a direction perpendicular to the Z direction and that is an axis when the upper collar portion 11 and the lower collar portion 12 are relatively rotated (a direction in which a shaft portion 12b described later extends). The width direction is defined as the X direction. In the X direction, one of the directions is positive and the opposite direction is negative. In addition, a direction perpendicular to the Z direction and the X direction is a length direction, and this is a Y direction. In the Y direction, the direction from the base of the heel (rotation axis side) to the tip (opposite to the rotation axis) is positive, and the opposite direction is negative. In the Y direction, the positive direction coincides with the insertion direction when the colposcope 1 is inserted into the subject's vaginal opening, and the negative direction coincides with the direction in which the colposcope 1 is extracted from the vaginal opening.

  As for the upper collar part 11 and the lower collar part 12, one rotates relatively with respect to the other so that the front-end | tip of a collar may open or close. The upper collar part 11 and the lower collar part 12 are formed in a shape in which the width in the X direction becomes narrower from the base of the collar toward the tip.

  FIG. 5 is a cross-sectional view of the colposcope 1 taken along the YZ plane passing through the center in the width direction. As shown in the figure, the upper collar part 11 and the lower collar part 12 have a distance D between the upper collar part 11 and the lower collar part 12 from the root of the collar to the tip (toward the positive side in the Y direction). It is formed in a shape in which (interval in the Z direction) is narrowed.

  FIG. 6 is a cross-sectional view of the colposcope 1 taken along the ZX plane including the AA line of FIG. FIG. 7 is a cross-sectional view of the colposcope 1 taken along the ZX plane including the line BB in FIG. The upper collar portion 11 is formed in a curved shape that is convex upward in the ZX plane. The lower collar portion 12 is formed in a curved shape convex downward in the ZX plane.

  The upper collar part 11 has a through hole 11a penetrating in the thickness direction (for example, the Z direction). The cover member 20 (in particular, the upper cover member 21 described later) can be attached to the upper collar portion 11 by, for example, insert molding. If the through-hole 11a is formed in the upper collar part 11, the cover member 20 will be connected by the outer peripheral surface 11P side and the inner peripheral surface 11Q side of the upper collar part 11 through the through-hole 11a. In this case, since the cover member 20 on the inner peripheral surface 11Q side is prevented from coming off, the cover member 20 can be fixed to the upper collar portion 11 without an adhesive.

  In this embodiment, the upper collar part 11 has two through holes 11a, but the number of the through holes 11a is not limited to two, and may be one, There may be three or more. Moreover, in the upper collar part 11, although the two through-holes 11a are located side by side in the Y direction, they may be arranged in the X direction, or may be displaced in both the X direction and the Y direction. Also good.

  Similarly, the lower collar part 12 has a through hole 12a that penetrates in the thickness direction (for example, the Z direction). When the cover member 20 (especially, the lower cover member 22 described later) is attached to the lower collar part 12 by, for example, insert molding, the outer circumferential surface 12P side and the inner circumferential surface 12Q side of the lower collar part 12 through the through hole 12a. The cover member 20 is connected. In this case, since the cover member 20 on the inner peripheral surface 12Q side is prevented from coming off, the cover member 20 can be fixed to the lower collar portion 12 without an adhesive.

  In this embodiment, the lower collar part 12 has two through holes 12a, but the number of the through holes 12a is not limited to two, and may be one, There may be three or more. Moreover, in the lower collar part 12, although the two through-holes 12a are located side by side in the Y direction, they may be arranged in the X direction, or may be shifted in both the X direction and the Y direction. Also good.

  The lower collar portion 12 has a shaft portion 12b on the negative side in the Y direction, that is, on the root side of the collar. The shaft portion 12b is a rotation shaft extending in the X direction, and is provided on the positive side and the negative side in the X direction with respect to the center in the width direction of the lower collar portion 12, respectively. Each shaft portion 12b is inserted into a hole portion 11b provided in the upper collar portion 11 from the inner side (inner peripheral surface 11Q side). Thereby, the lower collar part 12 can be rotated relative to the upper collar part 11 with the shaft part 12b as a pivot axis.

  The support portion 13 is a support body that supports the upper collar portion 11. In the present embodiment, the upper collar portion 11 and the support portion 13 are integrally formed so as to be bent at an angle of 100 ° or more. Of course, the upper collar portion 11 and the support portion 13 may be configured by separate members and connected to each other.

  An opening 13a is provided at the upper portion of the support portion 13 on the negative side in the Y direction. The opening 13a is formed so as to surround the Y-axis with the upper collar portion 11 and the lower collar portion 12 closed. The inside of the opening 13a communicates with the space between the upper collar portion 11 and the lower collar portion 12. Accordingly, when the user of the colposcope 1 such as a doctor inserts the colposcope 1 into the subject's vaginal opening and opens the upper buttocks 11 and 12, the vaginal cavity is opened through the opening 13 a. The inside can be examined.

  The grip portion 14 is formed integrally with the lower collar portion 12 so as to extend downward from the lower collar portion 12 at approximately 90 ° (negative side in the Z direction). Thereby, the user of the colposcope 1 can operate the grip part 14 to rotate the lower collar part 12 relative to the upper collar part 11.

  In the above configuration, when the user grasps the support portion 13 and the grip portion 14 so that the support portion 13 and the grip portion 14 approach each other, that is, the interval between the support portion 13 and the grip portion 14 in the Y direction is narrowed. The lower collar portion 12 rotates downward about the shaft portion 12b. As a result, the tip of the heel opens as shown in FIGS. Conversely, when the support portion 13 and the gripping portion 14 are moved away (when the interval between the support portion 13 and the gripping portion 14 in the Y direction is widened), the lower collar portion 12 rotates upward about the shaft portion 12b. As a result, the tip of the heel closes as shown in FIG.

  Therefore, the user of the colposcope 1 operates the colposcope 1 so that the tip of the heel is closed when the colposcope 1 is inserted into and extracted from the vaginal opening of the subject. At this time, the user rotates the colposcope 1 around the Y axis as necessary. On the other hand, when the vaginal opening is widened to examine the inside of the vaginal cavity, the user operates the colposcope 1 so that the tip of the eyelid opens after inserting the colposcope 1 into the subject's vaginal opening. To do.

  Note that the colposcope 1 of the present embodiment has a stopper for maintaining the tip of the heel in an open state (fixing the positional relationship between the support 13 and the grip 14) on the support 13 or the grip 14. Although it does not have, the structure which has the said stopper may be sufficient.

(Body material)
The main body 10 is made of a hard resin having a relatively high hardness. As the hard resin, it is desirable to use a resin having a Rockwell hardness R scale of 85 or more and 120 or less. As the resin having such a hardness range, for example, plastic resins such as ABS (acrylonitrile butadiene styrene) and PP (polypropylene) can be used. The Rockwell hardness of ABS is 90-115 on the R scale, and the Rockwell hardness of PP is 85-110 on the R scale.

  Here, the details of the Rockwell hardness will be described. Rockwell hardness is a kind of indentation hardness and is a hardness measured by a Rockwell test. That is, the indenter is pressed against the sample surface with a reference load, and then pressed with a constant test load. When returning to the reference load again, the hardness is obtained by a predetermined calculation formula from the difference in the depth of the depression in the two reference loads before and after. Rockwell hardness has several scales with different indenter, load, and hardness formulas depending on the applied material. For example, in the R scale, the hardness is measured using a steel ball indenter having a diameter of 1/2 inch and a test load of 60 kg. On the C scale, the hardness is measured using a conical diamond indenter with a reference load of 10 kg, an apex angle of 120 degrees and a tip radius of 0.2 mm, and a test load of 150 kg.

In addition, the calculation formula when calculating | requiring Rockwell hardness by R scale is as follows.
HR = 130-500h
here,
HR: Rockwell hardness h: Actual dent depth when the reference load is zero (mm)

The calculation formula for obtaining the Rockwell hardness on the C scale is as follows.
HR = 100-500h
here,
HR: Rockwell hardness h: Actual dent depth when the reference load is zero (mm)

  The main body 10 is folded with respect to the support part 13 or the grip part 14 without breaking the upper collar part 11 and the lower collar part 12 with the upper collar part 11 and the lower collar part 12 inserted into the vaginal opening. Not), it is necessary to have strength that can widen the vaginal opening. If the Rockwell hardness of the main body 10 is less than 85 on the R scale, the main body 10 is too soft and it is difficult to ensure the necessary strength.

  On the contrary, if the Rockwell hardness of the main body 10 exceeds 120 on the R scale, the main body 10 is too hard and it becomes difficult to ensure flexibility. If the main body 10 is not flexible, the main body 10 hardly deforms due to the reaction force from the vaginal opening when the upper buttocks 11 and 12 are inserted into the subject's vaginal opening to widen the vaginal opening. Therefore, it becomes easy for the subject to feel pain.

  Therefore, when the hardness of the main body 10 is 85 or more and 120 or less on the R scale of Rockwell hardness, while ensuring the necessary strength of the main body 10, the flexibility is ensured and the pain felt by the subject is reduced. It becomes possible. In particular, the above effect can be reliably obtained by configuring the main body 10 using ABS or PP whose Rockwell hardness satisfies the above range.

(About cover members)
Next, details of the cover member 20 will be described. The cover member 20 covers the outer peripheral surface and the inner peripheral surface of the vaginal opening insertion region R (see FIG. 5) in the upper collar portion 11 and the lower collar portion 12. More specifically, the cover member 20 includes an upper cover member 21 and a lower cover member 22. The upper cover member 22 covers the outer peripheral surface 11P and the inner peripheral surface 11Q in the vaginal opening insertion region R of the upper collar 11. The lower cover member 22 covers the outer peripheral surface 12P and the inner peripheral surface 12Q in the vaginal opening insertion region R of the lower collar 12. The thicknesses of the upper cover member 22 and the lower cover member 22 are preferably 0.8 mm or more, and more preferably 1 mm or more.

  Here, the vaginal opening insertion region R refers to a range in which insertion into the vaginal opening of the subject is allowed in the colposcope 1. The cover member 20 only needs to cover at least the vaginal opening insertion region R in the upper heel portion 11 and the lower heel portion 12, and is outside the range of the vaginal opening insertion region R (for example, negative in the Y direction with respect to the vaginal opening insertion region R). Of course, it doesn't matter if you cover up to the side).

  The cover member 20 is made of a softer resin than the main body 10. As a resin softer than the main body 10 described above, for example, a rubber-based material such as a thermoplastic elastomer, urethane rubber, silicone rubber, or fluorine rubber can be used. The rubber-based material has elasticity, and is softer than the hard resin constituting the main body 10 in this respect.

  Here, the Shore hardness Hs of styrene-based thermoplastic elastomer (for example, Aron Kasei Co., Ltd.), which is a kind of thermoplastic elastomer, and urethane rubber is 10 or more and 100 or less. The shore hardness Hs of the silicone rubber is 30 or more and 90 or less. Moreover, the Shore hardness Hs of fluororubber is 50 or more and 90 or less.

The Shore hardness Hs is the height of the hammer that rises when a steel hammer with a diamond tip embedded in the tip is dropped from a certain height h ₀ (mm) onto the sample surface. Where K is a proportionality constant, and the hardness is obtained based on the following equation. The Shore hardness Hs is measured using a Shore hardness tester.
Hs = K (h / h ₀ )

  Examples of a method for attaching the cover member 20 to the main body 10 include insert molding, vacuum casting, and a method using an adhesive. Considering that the colposcope 1 is a medical instrument and is inserted into the body of the subject, it is desirable to attach the cover member 20 to the main body 10 without using an adhesive that may affect the human body if possible. . In this respect, it is desirable to attach the cover member 20 to the main body 10 by insert molding or vacuum casting.

  In particular, when insert molding is used, the upper collar part 11 (support part 13 is also integrated) to which the upper cover member 21 is attached and the lower collar part 12 (the grip part 14 is also integrated) to which the lower cover member 22 is attached. The colposcope 1 can be assembled only by fitting, and the assembly is facilitated. In addition, since the number of times of touching the product is small, it is hygienic and the probability of mixing dust or the like at the time of manufacture is reduced.

  As in the present embodiment, at least the outer peripheral surface 11P of the upper collar portion 11 is covered with the cover member 20 (particularly the upper cover member 21), and at least the outer peripheral surface 12P of the lower collar portion 12 is covered with the cover member 20 (particularly the lower cover member). 22), the vaginal scope 1 is inserted into the subject's vaginal opening with the upper buttocks 11 and 12 closed, and then the tip of the heel is expanded. The person's vaginal opening is not in direct contact with the upper heel part 11 and the lower heel part 12, but is spread while in contact with the cover member 20 (upper cover member 21, lower cover member 22). As described above, the cover member 20 is made of a softer resin (rubber-based material) than the main body 10 and thus deforms by contact with the vaginal opening. Such deformation of the cover member 20 makes it difficult for the hardness of the main body 10 to be transmitted to the subject, and makes it difficult for the subject to feel pain. That is, the colposcope 1 is formed in a double structure of the main body 10 and the cover member 20, so that the vaginal scope 1 is widened by the colposcope 1 while ensuring the strength of the entire colposcope 1 by the main body 10 made of hard resin. The pain felt by the subject when touching can be reduced by the cover member 20.

  In particular, since the cover member 20 is made of a rubber-based material such as a thermoplastic elastomer, the cover member 20 is reliably deformed by contact with the vaginal opening. This makes it difficult for the subject to reliably feel the hardness of the main body 10, and makes it possible to reliably reduce the pain felt by the subject when the vaginal opening is widened by the colposcope 1.

  Here, when the Shore hardness Hs of the cover member 20 is less than 10, when the vaginal opening is widened by the colposcope 1, the cover member 20 may be deformed too much due to contact with the vaginal opening. In this case, there is a concern that the vaginal opening may be too close to the main body 10 (the upper buttocks 11 and the lower buttocks 12) and the subject may feel the hardness of the main body 10. On the contrary, when the Shore hardness Hs of the cover member 20 exceeds 100, the amount of deformation of the cover member 20 when the vaginal opening is widened by the colposcope 1 is small, and the subject obtained by providing the cover member 20 There is concern that the pain-reducing effect will be reduced. Considering the above, it can be said that the cover member 20 is desirably 10 to 100 in Shore hardness.

  In addition, in the vaginal opening insertion region R of the upper collar part 11, the cover member 20 covers the inner peripheral surface 11Q in addition to the outer peripheral surface 11P. Further, the cover member 20 covers the inner peripheral surface 12Q in addition to the outer peripheral surface 12P in the vaginal opening insertion region R of the lower collar 12 in a continuous manner. Thereby, for example, the upper collar part 11 and the cover member 20 are integrated by insert molding, the lower collar part 12 and the cover member 20 are integrated by insert molding, and these parts are assembled and the colposcope 1 is manufactured. Thus, mass production of the colposcope 1 is facilitated.

  The cover member 20 includes an upper cover member 21 that covers the outer peripheral surface 11P of the upper collar portion 11, and a lower cover member 22 that covers the outer peripheral surface 12P of the lower collar portion 12. In this configuration, when the colposcope 1 is inserted into the subject's vagina mouth with the upper heel portion 11 and the lower heel portion 12 closed, the subject's vagina mouth is located on the upper side. It spreads in contact with the cover member 21 and the lower cover member 22. Since the upper cover member 21 and the lower cover member 22 are softer than the main body 10, the upper cover member 21 and the lower cover member 22 are surely deformed by contact with the vaginal opening, thereby reliably reducing the pain felt by the subject.

(About the X direction edge part of an upper cover member and a lower cover member)
As shown in FIGS. 6 and 7, when the rotation axis direction when the upper collar part 11 and the lower collar part 12 are relatively rotated as in the present embodiment is the X direction, the upper cover member 21 and the lower cover member 22 are arranged such that the outermost end 21a in the X direction of the upper cover member 21 is the most in the X direction of the lower cover member 22 in a state where the upper flange portion 11 and the lower flange portion 12 are closed. It is desirable that the outer end 22a be in contact with the outer end 22a.

  FIG. 8 is a modification of the upper cover member 21 and the lower cover member 22, and the outermost end portion 21 a in the X direction of the upper cover member 21 with the upper flange portion 11 and the lower flange portion 12 closed. And the outermost end 22a in the X direction of the lower cover member 22 are separated from each other in the Z direction. If the colposcope 1 of this embodiment is the structure which covers the outer peripheral surface 11P of the upper collar part 11 with the upper cover member 21, and covers the outer peripheral surface 12P of the lower collar part 12 with the lower cover member 22, as shown in FIG. In addition, the end 21a and the end 22a may be separated in the Z direction. However, if the end portion 21a and the end portion 22a are separated in the Z direction, the end portion 21a and the end portion 22a independently form acute corners, and the portion that contacts the vaginal opening of the subject is sharp. It becomes. For this reason, when the edge part 21a and the edge part 22a contact the vaginal opening, the subject may feel pain.

  On the other hand, as shown in FIGS. 6 and 7, when the end 21a and the end 22a come into contact with the upper flange 11 and the lower flange 12 closed, the end 21a and the end 22a are integrated. Thus, the sharpness of the contact portion with the vaginal opening at the end 21a and the end 22a can be lowered as compared with the configuration of FIG. Accordingly, it is possible to further reduce the pain felt by the subject when the end 21a and the end 22a come into contact with the vaginal opening.

(About the amount of protrusion in the X direction of the upper cover member and the lower cover member)
As shown in FIG. 6, in the state where the upper collar part 11 and the lower collar part 12 are closed, the amount of protrusion in the X direction of the upper cover member 21 and the lower cover member 22 from the upper collar part 11 and the lower collar part 12 is set. , X1 (mm) respectively. At this time, the protrusion amount X1 is desirably 2 mm or more and 4 mm or less. The protrusion amount X1 desirably satisfies the above range in any cross section in the Y direction.

  Table 1 shows a plurality of colposcopes 1 in which the protrusion amounts X1 in the X direction of the upper cover member 21 and the lower cover member 22 are 1.5 mm, 2 mm, 2.45 mm, 3 mm, 4 mm, and 5 mm. The evaluation of each colposcope 1 when each colposcope 1 is used with respect to the subject is summarized. Here, as the upper cover member 21 and the lower cover member 22 of each colposcope 1, the Shore hardness Hs is 10 from the above-mentioned materials (thermoplastic elastomer, urethane rubber, silicone rubber, fluororubber). 30, 50, 70, 90, 100 were selected and prepared. Moreover, the thickness of the upper cover member 21 and the lower cover member 22 was 1 mm.

  Moreover, as the upper heel part 11 and the lower heel part 12 of each colposcope 1, the maximum width in the X direction in the vaginal opening insertion region R is 27 mm, and the length in the Y direction in the vaginal opening insertion region R is 55 mm. In the vaginal opening insertion region R in a state where the upper buttocks 11 and 12 are closed, the maximum width in the Z direction is 22 mm.

As a plurality of subjects, five 20-year-old women, 20-year-old women, 30-year-old women, 30-year-old women, 40-year-old women, and 40-year-old women were collected (30 people in total). Then, for each subject, the vaginal opening 1 and the vaginal opening were expanded by sequentially using the colposcope 1 (36 in total) having different protrusion amounts X1 and Shore hardness. Thereafter, based on the opinions of the subjects, each colposcope 1 was evaluated based on the following evaluation criteria.
《Pain level》
1: When the vaginal opening was widened by the colposcope, no pain was felt.
2: When the vaginal opening was widened by the colposcope, a slight pain was felt, but there was no problem.
3: I felt a little pain when I widened the vaginal opening with a colposcope, but there was no problem.
4: I felt pain when I widened the vaginal opening with a colposcope, but I was able to tolerate it.
5: When I widened the vaginal opening with a colposcope, I felt pain that forced me to endure a lot.
"Evaluation criteria"
A: The number of level 1 subjects was the largest.
○: The number of level 2 subjects was the largest.
Δ: The number of level 3 subjects was the largest.
Δ △: The number of level 4 subjects was the largest.
X: The number of level 5 subjects was the largest.

  From Table 1, when the protrusion amount X1 is less than 2 mm, when the Shore hardness Hs of the upper cover member 21 and the lower cover member 22 is 50 or more, a subject who feels pain appears. This is considered to be due to the following reason. That is, when the protrusion X1 is small and the upper cover member 21 and the lower cover member 22 are relatively hard, the upper cover member 11 and the lower flange 12 are inserted into the vaginal opening and spread. 21 and the lower cover member 22 in the X-direction end 21a and end 22a are less deformed by contact with the vaginal opening. For this reason, the hardness of the upper collar part 11 and the lower collar part 12 is easily transmitted to the subject, and the subject can easily feel the hardness of the upper collar part 11 and the lower collar part 12.

  On the other hand, when the protrusion amount X1 exceeds 4 mm, the test subject tends to feel pain when the Shore hardness Hs of the upper cover member 21 and the lower cover member 22 is 70 or less. This is considered to be due to the following reason. That is, when the protrusion amount X1 is large and the upper cover member 21 and the lower cover member 22 are relatively soft, the amount of deformation increases. Then, the angular end portion 11c of the upper collar portion 11 and the angular end portion 12c of the lower collar portion 12 in the X direction approach the vaginal opening. For this reason, the subject can easily feel the hardness of the end portion 11c of the upper collar portion 11 and the end portion 12c of the lower collar portion 12.

  Therefore, by setting the protrusion amount X1 to 2 mm or more and 4 mm or less, the upper and lower collar parts 11 and 12 are inserted into the vaginal opening and spread regardless of the hardness of the upper cover member 21 and the lower cover member 22. It can be said that the pain felt by the subject can be reduced.

(Ends in the Y direction of the upper cover member and the lower cover member)
As shown in FIG. 5, the upper cover member 21 and the lower cover member 22 are opposite to the rotation axis in the Y direction of the upper cover member 21 in a state where the upper flange portion 11 and the lower flange portion 12 are closed. It is desirable that the end portion 21b is formed in a shape that comes into contact with the end portion 22b on the opposite side of the rotation axis in the Y direction of the lower cover member 22.

  FIG. 9 shows another modification of the upper cover member 21 and the lower cover member 22, and the end portion 21 b at the front end in the Y direction of the upper cover member 21 with the upper flange portion 11 and the lower flange portion 12 closed. And a state in which the end 22b at the front end in the Y direction of the lower cover member 22 is separated in the Z direction. If the colposcope 1 of this embodiment is the structure which covers the outer peripheral surface 11P of the upper collar part 11 with the upper side cover member 21, and covers the outer peripheral surface 12P of the lower collar part 12 with the lower side cover member 22, it will be like FIG. In addition, the end 21b and the end 22b may be separated in the Z direction. However, when the end portion 21b and the end portion 22b are separated in the Z direction, the end portion 21b and the end portion 22b each form an acute corner, and the portion that contacts the vaginal opening of the subject is sharp. It becomes. For this reason, when the edge part 21b and the edge part 22b contact the vaginal opening, the subject may feel pain.

  On the other hand, as shown in FIG. 5, when the end 21b and the end 22b come into contact with the upper collar 11 and the lower collar 12 closed, the end 21b and the end 22b are integrated. In order to come into contact with the subject's vaginal opening, the sharpness of the contact portion with the vaginal opening at the end 21b and the end 22b can be lowered as compared with the configuration of FIG. This makes it possible to further reduce the pain felt by the subject when the end 21b and the end 22b come into contact with the vaginal opening when the main body 10 is inserted into the vaginal opening.

(About the amount of protrusion in the Y direction of the upper cover member and the lower cover member)
As shown in FIG. 5, in the state where the upper collar part 11 and the lower collar part 12 are closed, the amount of protrusion in the Y direction of the upper cover member 21 and the lower cover member 22 from the upper collar part 11 and the lower collar part 12 is set. , Y1 (mm) respectively. At this time, the protruding amount Y1 is desirably 8 mm or more and 17 mm or less.

  Table 2 shows a plurality of colposcopes 1 in which the protruding amounts Y1 of the upper cover member 21 and the lower cover member 22 in the Y direction are 6 mm, 8 mm, 9.8 mm, 12 mm, 17 mm, and 18 mm. The evaluation of each colposcope 1 when each colposcope 1 is used for the examiner is summarized. Here, as the upper cover member 21 and the lower cover member 22 of each colposcope 1, the Shore hardness Hs is 10 from the above-mentioned materials (thermoplastic elastomer, urethane rubber, silicone rubber, fluororubber). 30, 50, 70, 90, 100 were selected and prepared.

  Moreover, as the upper heel part 11 and the lower heel part 12 of each colposcope 1, the maximum width in the X direction in the vaginal opening insertion region R is 27 mm, and the length in the Y direction in the vaginal opening insertion region R is 55 mm. In the vaginal opening insertion region R in a state where the upper buttocks 11 and 12 are closed, the maximum width in the Z direction is 22 mm.

As a plurality of subjects, five 20-year-old women, 20-year-old women, 30-year-old women, 30-day women, 40-year-old women, and 40-year-old women were collected (30 people in total). Then, for each subject, the vaginal scope 1 (a total of 36 pieces) having different protrusion amounts Y1 and different shore hardnesses was sequentially used to insert and remove the vaginal opening and widen the vaginal opening. Thereafter, based on the opinions of the subjects, each colposcope 1 was evaluated based on the following evaluation criteria.
《Pain level》
1: No pain was felt when inserted into the vaginal opening with the upper and lower buttocks closed.
2: When inserted into the vaginal opening with the upper and lower buttocks closed, a slight pain was felt, but there was no problem.
3: When inserted into the vaginal opening with the upper and lower buttocks closed, a slight pain was felt, but there was no problem.
4: Pain was felt when inserted into the vaginal opening with the upper and lower buttocks closed, but only tolerable.
5: When inserted into the vaginal opening with the upper buttocks and lower buttocks closed, I felt pain that forced me to endure considerably.
"Evaluation criteria"
A: The number of level 1 subjects was the largest.
○: The number of level 2 subjects was the largest.
Δ: The number of level 3 subjects was the largest.
Δ: The number of level 4 subjects was the largest.
X: The number of level 5 subjects was the largest.

  From Table 2, when the protrusion amount Y1 is less than 8 mm, when the Shore hardness Hs of the upper cover member 21 and the lower cover member 22 is 50 or more, a subject who feels pain appears. This is considered to be due to the following reason. That is, when the protrusion Y1 is small and the upper cover member 21 and the lower cover member 22 are relatively hard, the upper cover member 21 and the lower cover member 21 and the lower cover member 12 are inserted when the upper collar part 11 and the lower collar part 12 are inserted into the vaginal opening. The amount of deformation of the end portion 21b and the end portion 22b in the Y direction of the side cover member 22 due to contact with the vaginal opening is small. For this reason, the hardness of the upper collar part 11 and the lower collar part 12 is easily transmitted to the subject, and the subject can easily feel the hardness of the upper collar part 11 and the lower collar part 12.

  On the other hand, when the protrusion amount Y1 exceeds 17 mm, the test subject tends to feel pain when the Shore hardness Hs of the upper cover member 21 and the lower cover member 22 is 70 or less. This is considered to be due to the following reason. That is, when the protrusion Y1 is large and the upper cover member 21 and the lower cover member 22 are relatively soft, the deformation amount increases. Then, the angular end portion 11d of the upper collar portion 11 and the angular end portion 12d of the lower collar portion 12 in the Y direction approach the vaginal opening. For this reason, the subject can easily feel the hardness of the end portion 11d of the upper collar portion 11 and the end portion 12d of the lower collar portion 12.

  Therefore, by setting the protrusion Y1 to 8 mm or more and 17 mm or less, regardless of the hardness of the upper cover member 21 and the lower cover member 22, when inserting the upper buttocks 11 and 12 into the vaginal opening. It can be said that the pain felt by the subject can be reduced.

<Embodiment 2>
Another embodiment of the present invention will be described below with reference to the drawings.

(About the hollow of the main body and cover member)
FIG. 10 is a perspective view of the colposcope 1 of the present embodiment, and FIG. 11 is a plan view of the colposcope 1. In the present embodiment, in the colposcope 1 according to the first embodiment, the upper collar portion 11 has a main body recess portion 11e, and the lower collar portion 12 has a main body recess portion 12e.

  The main body depression 11e is a depression that is recessed inward in the X direction (center side in the width direction) in the upper collar 11. Similarly, the main body depression 12e is a depression that is recessed inward in the X direction (center side in the width direction) in the lower collar 12. The main body hollow part 11e and the main body hollow part 12e are provided in the vaginal opening insertion region R (see FIG. 5) in the upper collar part 11 and the lower collar part 12. It should be noted that the main body recess 11e and the main body recess 12e may be recessed at least inward in the X direction, and of course may be further recessed inward in the Z direction.

  Moreover, the cover member 20 has cover hollow parts 21e and 22e. More specifically, the upper cover member 21 has a cover recess portion 21e, and the lower cover member 22 has a cover recess portion 22e. The cover recess 21 e is a recess that is recessed inward in the X direction in the upper cover member 21, and is positioned along the main body recess 11 e of the upper collar portion 11. Similarly, the cover recess 22 e is a recess that is recessed inward in the X direction in the lower cover member 22, and is located along the main body recess 12 e of the lower collar 12.

  Thus, since the cover member 20 (the upper cover member 21 and the lower cover member 22) has the cover recess portion 21e and the cover recess portion 22e, the upper flange portion 11 and the lower flange portion 12 are removed from the subject. When the vaginal opening is widened by inserting the vaginal opening, the vaginal opening is recessed inward in the X direction along the outer shape of the cover recess portion 21e and the cover recess portion 22e, and the opening area of the vaginal opening decreases. Thereby, the pain which a subject feels can further be reduced.

  Moreover, the cover hollow part 21e is located along the main body hollow part 11e of the upper collar part 11, and the cover hollow part 22e is located along the main body hollow part 12e of the lower collar part 12, The cover recess portion 21e and the cover recess portion 22e are indented inward in the X direction along the surface shapes (depression shapes) of the main body recess portion 11e and the main body recess portion 12e. Therefore, the cover hollow portion 21e and the cover hollow portion 22e that are recessed inward in the X direction can be easily realized.

(About the amount of depression in the X direction of the cover depression)
As shown in FIG. 12, the maximum width in the X direction of the cover member 20 (upper cover member 21, lower cover member 22) is W (mm), and the amount of recess in the X direction of the cover recess 21e and the cover recess 22e. Is X2 (mm), the depression amount X2 is preferably 0.02 W or more and 0.1 W or less. The reason is as follows. In addition, said hollow amount X2 points out the distance of the outermost edge part Xout and innermost edge part Xin of a hollow (a cover hollow part 21e, the cover hollow part 22e) in a X direction.

  Table 3 provides a plurality of colposcopes 1 having a dent amount X2 of 0.01 W, 0.02 W, 0.05 W, 0.1 W, 0.2 W, and each colposcope for a plurality of subjects. The evaluation of each colposcope 1 when 1 is used is summarized. Here, as the upper cover member 21 and the lower cover member 22 of each colposcope 1, the Shore hardness Hs is 10 from the above-mentioned materials (thermoplastic elastomer, urethane rubber, silicone rubber, fluororubber). 30, 50, 70, 90, 100 were selected and prepared. Here, W = 25 mm.

  Moreover, as the upper heel part 11 and the lower heel part 12 of each colposcope 1, the maximum width in the X direction in the vaginal opening insertion region R is 27 mm, and the length in the Y direction in the vaginal opening insertion region R is 55 mm. In the vaginal opening insertion region R in a state where the upper buttocks 11 and 12 are closed, the maximum width in the Z direction is 22 mm.

As a plurality of subjects, five 20-year-old women, 20-year-old women, 30-year-old women, 30-day women, 40-year-old women, and 40-year-old women were collected (30 people in total). Then, for each subject, insertion and removal into the vaginal opening and widening of the vaginal opening were performed sequentially using the colposcope 1 (36 pieces in total) having different dent amounts X2 and Shore hardness. Thereafter, based on the opinions of the subjects, each colposcope 1 was evaluated based on the following evaluation criteria.
《Pain level》
1: No pain was felt both when the vaginal opening was widened by the colposcope and when the colposcope was removed from the vaginal opening.
2: Faint pain was felt at least when the vaginal opening was widened by the colposcope and when the colposcope was pulled out of the vaginal opening, but there was no problem.
3: At least one of the time when the vaginal opening was widened by the colposcope and when the colposcope was pulled out from the vaginal opening, a slight pain was felt, but there was no problem.
4: Pain was felt at least when the vaginal opening was widened by the colposcope and when the colposcope was pulled out of the vaginal opening, but it was tolerable.
5: When at least one of the time when the vaginal opening was widened by the colposcope and when the colposcope was pulled out from the vaginal opening, pain was felt to a great extent.
"Evaluation criteria"
A: The number of level 1 subjects was the largest.
○: The number of level 2 subjects was the largest.
Δ: The number of level 3 subjects was the largest.
Δ: The number of level 4 subjects was the largest.
X: The number of level 5 subjects was the largest.

  From Table 3, when the protrusion amount X2 is less than 0.02 W, the amount of depression with respect to the entire width of the cover depression portion 21e and the cover depression portion 22e is small. Therefore, when the upper buttocks 11 and 12 are inserted into the subject's vaginal opening and the vaginal opening is widened, the opening of the vaginal opening is reduced by recessing the vaginal opening inward in the X direction. This reduces the effect of reducing the pain felt by the subject. Such a reduction in the effect tends to appear particularly when the upper cover member 21 and the lower cover member 22 are relatively hard.

  On the other hand, when the amount of depression X2 exceeds 0.1 W, the cover depression 21e and the cover depression 22e are excessively depressed with respect to the entire width, so that the upper vagina 11 and the lower heel 12 are closed from the vaginal opening. When pulling out, the cover recess 21e and the cover recess 22e are easily caught at the vaginal opening. For this reason, especially when the upper cover member 21 and the lower cover member 22 are relatively hard, the subject can easily feel pain due to the above-mentioned catch.

  Therefore, by appropriately defining the depression amount X2 within the above range, both when the vaginal opening is widened by the upper heel part 11 and the lower heel part 12 and when the upper heel part 11 and the lower heel part 12 are removed from the vagina opening. Thus, the pain felt by the subject can be surely reduced. Note that it was confirmed that the same results as in Table 3 were obtained even when W = 25 mm.

(About other configurations of the colposcope)
FIG. 13 is a cross-sectional view showing another configuration of the colposcope 1. In the colposcope 1, the upper cover member 21 may be formed so as to cover only the outer peripheral surface 11 </ b> P of the upper collar portion 11. Similarly, the lower cover member 22 may be formed so as to cover only the outer peripheral surface 12P of the lower collar portion 12. That is, the upper cover member 21 may be formed without covering the inner peripheral surface 11Q of the upper collar portion 11, and the lower cover member 22 is formed without covering the inner peripheral surface 12Q of the lower collar portion 12. Also good.

  Even in this configuration, when the upper and lower heel portions 11 and 12 of the colposcope 1 are inserted into the subject's vaginal opening and the vaginal opening is widened, the upper cover member 21 and the lower cover member 22 are Contact with mouth. The cover member 20 is made of a softer resin than the main body 10 and is deformed by contact with the vaginal opening, so that the hardness of the main body 10 is not easily transmitted to the subject. Therefore, even if it is the structure of FIG. 13, the pain which a subject feels when the vaginal opening is expanded by the colposcope 1 can be reduced.

  In the case of the configuration of FIG. 13, if a downward projecting portion 21 f is provided on the inner side of the upper cover member 21 (side facing the upper collar portion 11), by fitting the projecting portion 21 f into the through hole 11 a, The upper cover member 21 can be fixed to the upper collar portion 11 without an adhesive. Similarly, if an upward projecting portion 22f is provided on the inner side of the lower cover member 22 (the side facing the lower collar portion 12), the lower cover member 22 is fitted into the through hole 12a by fitting the projecting portion 22f into the through hole 12a. Can be fixed to the lower collar 12 without an adhesive.

  The embodiment of the present invention has been described above, but the scope of the present invention is not limited to this, and various modifications can be made without departing from the spirit of the invention. In addition, the structures described in the embodiments can be combined as appropriate.

  The colposcope of the present invention can be used as a medical instrument for examination or examination in the vaginal cavity of a subject.

DESCRIPTION OF SYMBOLS 1 colposcope 10 main body 11 upper collar part 11a through-hole 11e main body hollow part 11P outer peripheral surface 11Q inner peripheral surface 12 lower collar part 12a through-hole 12e main body hollow part 12P outer peripheral surface 12Q inner peripheral surface 20 cover member 21 upper cover member 21a end Portion 21b end portion 21e cover recess portion 22 lower cover member 22a end portion 22b end portion 22e cover recess portion R vaginal opening insertion region

Claims (15)

A colposcope comprising a main body made of a hard resin and having an upper heel portion and a lower heel portion that rotate relatively,
A cover member that covers the outer peripheral surface of the vaginal opening insertion region in the upper buttocks and the lower buttocks, and further contacts the vaginal opening of the subject when using the colposcope ;
The cover member is made of a softer resin than the main body, and the upper vagina and the lower heel are inserted into the vaginal opening of the subject and are rotated relatively to the vaginal opening. A colposcope characterized by being made of a rubber-based material that is deformed by contact with the vaginal opening when it is spread . The colposcope according to claim 1, wherein the hardness of the main body is 85 or more and 120 or less on the R scale of Rockwell hardness. The colposcope according to claim 1 or 2, wherein the cover member has a Shore hardness Hs of 10 or more and 100 or less. The colposcope according to any one of claims 1 to 3, wherein the upper collar part and the lower collar part each have a through-hole penetrating in the thickness direction. 5. The cover member according to claim 1, wherein the cover member continuously covers an inner peripheral surface in addition to the outer peripheral surface in the vaginal opening insertion region of the upper and lower collar portions. The described colposcope. The said cover member has an upper cover member which covers the outer peripheral surface of the said upper collar part, and a lower cover member which covers the outer peripheral surface of the said lower collar part, The any one of Claim 1 to 5 characterized by the above-mentioned. The colposcope described in Crab. When the rotation axis direction when the upper collar part and the lower collar part relatively rotate is the X direction,
The upper cover member and the lower cover member are arranged so that the outermost end portion in the X direction of the upper cover member is in the X direction of the lower cover member in a state where the upper collar portion and the lower collar portion are closed. The colposcope according to claim 6, wherein the colposcope is formed in a shape in contact with an outermost end portion of the lens. In the state where the upper collar part and the lower collar part are closed, the amount of protrusion in the X direction of the upper cover member and the lower cover member from the upper collar part and the lower collar part is X1 (mm), respectively. When
8. The colposcope according to claim 7, wherein the protrusion amount X1 is 2 mm or more and 4 mm or less. In a state in which the upper collar part and the lower collar part are closed, the upper collar part and the lower collar part are perpendicular to the direction in which the upper collar part and the lower collar part face each other, and the rotation axis direction of the upper collar part and the lower collar part When the direction perpendicular to Y is the Y direction,
The upper cover member and the lower cover member are configured such that, in a state where the upper collar portion and the lower collar portion are closed, an end portion of the upper cover member opposite to the rotation axis in the Y direction is the lower side. 9. The colposcope according to any one of claims 6 to 8, wherein the cover member is formed in a shape that comes into contact with an end portion on the opposite side of the rotation axis in the Y direction. In the state where the upper collar part and the lower collar part are closed, the amount of protrusion in the Y direction of the upper cover member and the lower cover member from the upper collar part and the lower collar part is Y1 (mm), respectively. When
The colposcope according to claim 9, wherein the protruding amount Y1 is 8 mm or more and 17 mm or less.
When the rotation axis direction when the upper collar part and the lower collar part relatively rotate is the X direction,
The colposcope according to any one of claims 1 to 10, wherein the cover member has a cover recess that is recessed inward in the X direction. The upper collar part and the lower collar part each have a main body depression that is recessed inward in the X direction,
The colposcope according to claim 11, wherein the cover recess is located along each of the body recesses. When the maximum width in the X direction of the cover member is W (mm), and the amount of depression in the X direction of the cover depression is X2 (mm),
The colposcope according to claim 11 or 12, wherein the depression amount X2 is 0.02W or more and 0.1W or less. A colposcope comprising a main body made of a hard resin and having an upper heel portion and a lower heel portion that rotate relatively,
A cover member that covers the outer peripheral surface of the vaginal opening insertion region in the upper and lower buttocks,
The cover member is made of a softer resin than the main body,
The upper and lower collar parts each have a through-hole penetrating in the thickness direction. A colposcope comprising a main body made of a hard resin and having an upper heel portion and a lower heel portion that rotate relatively,
A cover member that covers the outer peripheral surface of the vaginal opening insertion region in the upper and lower buttocks,
The cover member is made of a softer resin than the main body,
When the rotation axis direction when the upper collar part and the lower collar part relatively rotate is the X direction,
The cover member has a cover recess that is recessed inward in the X direction,
When the maximum width in the X direction of the cover member is W (mm), and the amount of depression in the X direction of the cover depression is X2 (mm),
The indentation amount X2 is 0.02 W or more and 0.1 W or less.

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