WO2010055908A1

WO2010055908A1 - Eyelid opener

Info

Publication number: WO2010055908A1
Application number: PCT/JP2009/069331
Authority: WO
Inventors: 英之二村
Original assignee: Hoya株式会社
Priority date: 2008-11-17
Filing date: 2009-11-13
Publication date: 2010-05-20
Also published as: JP2010119433A; JP5285398B2

Abstract

An eyelid opener provided with an arm (14) curved in a U-shape so that the arm has elasticity, and also with two eyelid-pressing sections (12) joined to opposite ends (14a), respectively, of the arm and engaged with an upper eyelid and a lower eyelid, respectively. The eyelid opener as a whole is configured as an integrally formed article of a resin and keeps the eyelids open by elastic repelling force of the arm. Each of the eyelid-pressing sections comprises a curved plate having a U-shaped cross-section and provided with an inner insertion section (12a) to be inserted to the inside of an eyelid and also with an outer pressing section (12b) for pressing the outside of the eyelid. The length (Lb) of the outer pressing section is set to be greater than the length (La) of the inner insertion section. Also, the thickness of the U-shaped cross-sectioned curved plate constituting each of the eyelid pressing sections (12) is changed so as to be gradually reduced from the curved section of the U-shape, said curved section being the root of the U-shape, toward both the tips of the curved plate.

Description

Opener

The present invention relates to an opener used to open the upper and lower eyelids, for example, during ophthalmic surgery, or when administering a drug into the eye.

When performing internal eye surgery such as cataract surgery, retinal vitreous surgery, glaucoma surgery etc. or extraocular surgery such as pterygium resection, disinfect the keratoconjunctiva and its surroundings, apply drapes, and then open it using an opener. Take action in the state of In recent years, intravitreal topical administration of angiogenesis inhibitors has been effective as a treatment for age-related macular degeneration, which is the leading cause of blindness in developed countries, and vitreous injection is explosive following approval of these agents. Is increasing. The vitreous injection of this angiogenesis inhibitor is carried out every month to bimonthly, and in this case as well, in each case, it is opened using a opener, and after the eye drop is effective, injection treatment is performed . Thus, the use of openers has increased significantly in recent years.

A conventional opening device is made of metal, and as an example thereof, one as shown in FIG. 3 and FIG. 4 is known.

An opener 60 shown in FIG. 3 is a wedge holding portion 62 formed of two curved plates which are hooked on upper and lower ridges at both ends of an arm 64 formed by bending a metal wire having a spring property into a U shape. Are joined by brazing or the like, and the open state is maintained by the spring repulsive force of the arm 64.

Each wedge pressing portion 62 is formed in a U-shaped cross section having an inner insertion piece 62a inserted into the inner side of the wedge and an outer pressing piece 62b pressing the outer side of the wedge, and the length La of the inner insertion piece 62a and the outer side The length Lb of the pressing piece 62b is set to be substantially equal. For example, the inner insertion piece 62a is usually designed to be about the size of a cornea diameter (about 11 mm) to about 14 mm because it has to be inserted smoothly without putting a heavy load on the hemorrhoids and the strong conjunctiva. . In addition, a wire having a high bending elastic modulus is used for the arm 64 so as not to lose the patient's own closing force.

Further, the opener 70 shown in FIG. 4 is provided with two hook holding portions 72 hooked to the upper and lower hooks at both ends of an arm 74 which is formed by being bent in a U shape so as to have springiness. Then, all parts are produced by bending one metal wire, and the spring repulsion force of the arm 74 keeps the open state.

Each wedge holding portion 72 is curved by a wire so as to have an inner insertion portion 72a inserted into the inner side of the ridge and an outer holding portion 72b pressing the outer side of the ridge, and the length La of the inner insertion portion 72a and the outer side The length Lb of the pressing portion 72b is set to be substantially equal. Also in this case, a metal wire having a high bending elastic modulus is used in order to make the spring force of the arm 74 not lose the closing force of the patient.

In these openers, as shown in FIG. 5 in which the opener 60 of FIG. 3 is used, the eyelid holding portions 62 provided at both ends of the arm 64 are the upper eyelid 102 and the lower eyelid 103 of the eye 101. The

hooks

102 and 103 can be opened by the spring repulsive force of the arm 64.

Examples of these metal openers are disclosed in Patent Document 1 and the like.

Further, as an opener other than metal, an opener made of synthetic resin or silicone rubber is also proposed in Patent Document 2. The open device proposed in this patent document has a flexible molded frame which is inserted into the eye socket and configured to cover in contact with a part of the eye, for eye surgery or examination. It has an opening to access. The patent also shows that the handle is attached to the forming frame.

Utility model registration 3102573 gazette Japanese Patent Application Publication No. 2005-512662

By the way, as mentioned above, although the scene where a glass opening device is used has increased greatly recently, since all metal glass opening devices are expensive, they can not be disposable and are sterilized I had to use it many times. The need for disposable use of such acupuncture device has not been realized yet, although it has been conventional from the viewpoint of infection prevention.

In addition, in the case of a metal opener, the bending elastic modulus of the arm tends to be large, and the following problem may occur because the portion directly in contact with the weir is a hard material.

That is, generally, the wider the surgical field is, the easier it is to perform the operation. Therefore, in order to secure a sufficient surgical field, a hard metal wire with a high bending elastic modulus is used for the arm. In the case of a patient who can not do so, it is easy to feel pain because the spring force is too strong, and may cause troubles such as a rise in vitreous pressure.

Further, since the conventional resin or silicone rubber opener described in Patent Document 2 is not of a type having an arm that exerts a spring action, it is inconvenient in use, and its structure is complicated and expensive. As with metal openers, they can not be disposable, and there has been the problem that they can not easily meet quantitative usage requirements.

In view of the above circumstances, the present invention is capable of performing the necessary function of opening the upper and lower eyelids in a convenient and sufficient manner and has an arm that exerts a spring action, yet has a flexible elasticity and softness. Contact can be achieved, yet it can be manufactured in large quantities at a low cost with a simple configuration, and hence can be disposable, can eliminate the hassle of sterilization, and requires a large amount of use It is an object of the present invention to provide an opener that can meet the

The opener according to the invention of claim 1 comprises a single arm which is curved in a U shape so as to have a spring property, and two hooks which are respectively coupled to both ends of the arm and which are hooked on the upper hook and the lower hook respectively. It is characterized in that it is configured as a single-piece product of resin as a whole, and has an open state maintained by the spring repulsive force of the arm.

The invention of claim 2 is the opener according to claim 1, wherein the wedge pressing portion has a cross section having an inner insertion piece inserted into the inner side of the wedge and an outer pressing piece pressing the outer side of the wedge. A U-shaped curved plate, the thickness of the curved plate is changed so that at least the tip of the inner insertion side is thinner than the U-shaped curved portion connecting the inner insertion piece and the outer pressing piece It is characterized by

The invention according to claim 3 is the opener according to claim 2, wherein the thickness of the curved plate is directed from the U-shaped curved portion where the inner insertion piece and the outer pressing piece are connected to both tip portions. It is characterized in that it gradually changes to become thinner.

The invention of claim 4 is the opener according to claim 2 or 3, wherein the arm is formed in a wire shape having a thickness of 1.5 mm or more.

The invention of claim 5 is the opener according to any one of claims 2 to 4, wherein the length of the outer pressing piece along the edge of the ridge is greater than that of the inner insertion piece. Is set to be large.

The invention of claim 6 relates to the opener according to claim 5, wherein a length in a direction along an edge of a ridge of the outer pressing piece is set to 16 mm or more, and the ridge of the inner insertion piece It is characterized in that the length in the direction along the edge is set to 15 mm or less.

The invention according to claim 7 is the opener according to any one of claims 2 to 6, wherein the dimension of the direction in which the inner insertion piece is inserted into the inside of the wedge rather than the outer pressing piece. Is set to be small.

The invention according to claim 8 is the opener according to any one of claims 1 to 6, characterized in that the whole is integrally formed of a thermoplastic resin.

The opening device according to the invention of claim 1 is of a very simple construction having only a U-shaped arm and two wedge holding portions at both ends of the arm, and further, the whole is integrally made of resin. Since it is formed by molding, it can be easily mass-produced at low cost. Therefore, disposable use is possible, and a large amount of use request can be met without requiring sterilization.

In addition, since the two wedge holding portions are provided at both ends of the arm having the spring property, it is possible to sufficiently perform the necessary function of opening the upper and lower ridges. In addition, because it is opened by the spring repulsive force of the resin arm which exerts more flexible elasticity than metal, it does not give pain in the case of the patient who can not open widely, and also vitreous pressure rise etc. There is no risk of causing problems.

Moreover, by using as a disposable type, the possibility of breakage due to repeated fatigue of the resin can be eliminated, so that the safety can be enhanced. In addition, since the portion directly in contact with the eyelids is made of a resin having a hardness lower than that of metal, it is possible to give the patient a soft touch feeling and to reduce the patient's feeling of strain.

According to the invention of claim 2, each wedge pressing portion is constituted by a curved plate having a U-shaped cross section having an inner insertion piece inserted inside the wedge and an outer pressing piece pressing the outer side of the wedge, and a curved plate Since the thickness of at least the tip of the inner insertion side is thinner than the U-shaped curved part connecting the inner insertion piece and the outer holding piece, the strength of the heel holding part made of resin The patient's feeling of strain when inserting the inner insertion piece into the inside of the eyelid can be reduced while keeping the

That is, in the case of forming the crucible holding portion with a metal plate or with a wire rod, it is very difficult to change the thickness of the crucible holding portion and the like in the case of forming the crucible holding portion with a metal plate. However, in the case of a plastic opener, it is possible to easily change the thickness of the curved plate that composes the tack holding part simply by adding the dimension setting according to the thickness change to the mold during molding. Can be given to Therefore, by reducing the thickness of at least the distal end portion of the inner insertion piece, it is possible to reduce the burden on the patient when inserting the inner insertion piece into the inside of the eyelid. In addition, although the thickness of the tip of the inner insertion piece is reduced, the thickness of the U-shaped curved portion on the root side is set thick, so the strength of the connecting portion between the inner insertion piece and the outer pressing piece is sufficient. It can be kept large and can be made durable against cracking and breakage.

According to the invention of claim 3, the thickness of the curved plate constituting the wedge pressing portion is changed gradually from the U-shaped curved portion where the inner insertion piece and the outer pressing piece are connected to both tip portions. Because of this, the effect of the invention of claim 2 can be more remarkably exhibited. In addition, since the thickness gradually decreases from the U-shaped curved portion toward both tip portions, in the resin molding, from the U-shaped curved portion on the root side toward both tip portions. The flow of resin can be smoothed, and the mold can be easily removed when it is removed from the mold.

According to the invention of claim 4, since the arm is formed in the shape of a wire having a thickness of 1.5 mm or more, a spring force sufficient for opening can be applied to the resin arm. In addition, since the arm is in the form of a wire, molding can be facilitated.

According to the invention of claim 5, since the length in the direction along the edge of the ridge is set larger in the outer pressing piece than in the inner insertion piece, the inner insertion piece can be smoothly inserted into the back side of the ridge. At the same time, the large size of the outer presser foot can hide the many eyebrows of the upper and lower eyelids and their roots.

For example, when performing an intravitreal injection of an anti-angiogenic agent, a sterile opener will be worn directly into the eye without drapes, but the size of the outer clamp is set larger This makes it possible to cover in large areas the many eyebrows that may be contaminated with bacteria and dirt and their roots, whereby the injection needle that touches the eyebrows is inserted into the eye. The risk of developing endocarditis can be reduced. In addition, since the size of the outer pressing piece is increased, the upper and lower eyelids can be pressed with a wide surface, so that the pain of the patient is reduced, and it becomes difficult to induce an increase in vitreous pressure and the like.

According to the invention of claim 6, since the length of the outer side pressing piece is 16 mm or more and the length of the inner insertion piece is 15 mm or less, a feeling of strain on the patient when inserting the inner insertion piece on the back side of the heel. While reducing it, it becomes possible to perform safe treatment by holding down the eyelashes on the front side of the eyelid.

According to the invention of claim 7, since the dimension of the direction in which the inner insertion piece is inserted into the inner side of the wedge is set smaller than that of the outer pressing piece, the inner insertion piece is smoothly inserted into the back side of the wedge. At the same time, the large size of the outer presser foot can hide the many eyebrows of the upper and lower eyelids and their roots.

According to the invention of claim 8, mass production can be carried out inexpensively by injection molding.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1 shows the configuration of the opener according to the embodiment, (a) is a perspective view, (b) is a plan view, (c) is a side view, (d) is a front view, (e) is (d) It is an enlarged view of Ie part. Moreover, FIG. 2 is a figure which shows the use condition.

The opener 10 is connected to a single wire-like arm 14 curved in a U-shape to have springiness, and both ends 14 a of the arm 14, and the upper eyelid 102 and the lower eyelid of the eye 101 are connected. It has two hook holding parts 12 to be hooked to 103 respectively. The opener 10 is configured as a single-piece product of polymethyl methacrylate which is a thermoplastic resin as a whole, and maintains the open state by the spring repulsive force of the arm 14.

The upper and lower eyelid presser parts 12 are constituted by a curved plate having a U-shaped cross section having an inner insertion piece 12a inserted into the inner side of the eyelid and an outer presser piece 12b pressing the outer side of the eyelid. As shown in, the length Lb in the direction along the edge of the outer holding piece 12b is set larger than the length La in the direction along the edge of the inner insertion piece 12a.

Further, as shown in FIG. 1 (e), the thickness of the curved plate constituting the wedge pressing portion 12 gradually increases from the U-shaped curved portion where the inner insertion piece 12a and the outer pressing piece 12b are connected to both tip portions. It has changed to become thinner. That is, the dimensions t2 and t3 are smaller than the dimension t1 in the drawing (t1> t2 = t3). In this case, for example, t1 = about 0,6 mm and t2 = t3 = about 0,4 mm. The allowable width of the dimension of t1 is preferably, for example, in the range of 0.5 to 0.7 mm, and the allowable width of the dimensions of t2 and t3 is, for example, preferably in the range of 0.3 to 0.5 mm . If the minimum thickness portion is too thin, it is likely to be broken, so it is necessary to secure a thickness that prevents cracking at least.

In addition, although it is preferable to provide continuously the change of the thickness of the curved plate which comprises the toe holding part 12, you may provide it in steps.

Further, the upper and lower eyelid holding portions 12 having a U-shaped cross section are formed to be slightly open at an angle θ (about 20 °) opposite to the side on which the arm 14 is present. Further, the back portions (portions corresponding to the bottom of the U-shape) of the upper and lower eyelid holding portions 12 having a U-shaped cross section are concavely curved with a curvature of radius R.

In addition, the arm 14 is formed in a wire shape having a circular cross section with a diameter of about 2 mm. The inventors have performed bending tests using arms of several diameters, but have found that a diameter of at least 1.5 mm is required to achieve the required stiffness and elasticity.

In addition, as a result of actually making a model and testing it, the lateral width (length in the direction along the edge of the ridge) of the outer side pressing portion 12b is preferably set to 16 mm or more, preferably about 17 mm or more. It has been found that the width (length along the edge of the ridge) of 12a is set to about 15 mm or less, preferably 14 mm or less.

As described above, the opener 10 is of a very simple construction having only the U-shaped arm 14 and the two hook holding portions 12 at both ends 14 a of the arm 14. Since the whole is formed by integral molding of a thermoplastic resin, mass production can be easily achieved at low cost. Therefore, disposable use is possible, and a large amount of use request can be met without requiring sterilization.

Further, since the two wedge holding portions 12 are provided at both ends 14a of the arm 14 having the spring property, the necessary function of mounting as shown in FIG. It is easy to use and can be fully accomplished. And although it is resin as shown in FIG. 2, sufficient operation field can be ensured. In addition, because it is opened by the spring repulsive force of the arm 14 made of resin that exerts more flexible elasticity than metal, it does not give pain in the case of a patient who can not be opened widely, and the vitreous pressure rise etc. There is no danger of causing

Moreover, by using as a disposable type, the possibility of breakage due to repeated fatigue of the resin can be eliminated, so that the safety can be enhanced. In addition, since the portion (the heel holding portion 12) which is in direct contact with the

heels

102 and 103 is made of a resin having a hardness lower than that of metal, a soft touch can be given to the patient, and the patient feels burdened. Can be reduced.

Further, each wedge holding portion 12 is formed of a curved plate having a U-shaped cross section having an inner insertion piece 12a inserted into the inside of the

wedges

102 and 103 and an outer pressing piece 12b pressing the outer side of the

wedges

102 and 103; Since the thickness of the curved plate is changed so that at least the tip on the side of the inner insertion piece 12a becomes thinner than the U-shaped curved portion where the inner insertion piece 12a and the outer pressing piece 12b are connected, it is made of resin The patient's feeling of strain when inserting the inner insertion piece 12a into the inside of the eyelid can be reduced while maintaining the strength of the eyelid holding portion 12.

For example, in the conventional metal opener, it is very difficult to change the thickness of the wedge holding portion when the wedge holding portion is formed of a metal plate or a wire. Although it was not, in the case of the opener 10 made of resin as in this embodiment, the wedge holding portion 12 can be easily configured simply by adding the dimension setting according to the thickness change to the mold at the time of molding. It is possible to freely change the thickness of the curved plate. Therefore, by reducing the thickness of at least the tip portion of the inner insertion piece 12a, it is possible to reduce the burden on the patient when inserting the inner insertion piece 12a into the inside of the eyelid. Moreover, although the thickness of the tip of the inner insertion piece 12a is reduced, the thickness of the U-shaped curved portion on the root side is set thick, so that the connection portion between the inner insertion piece 12a and the outer pressing piece 12b The strength can be maintained sufficiently high, and resistance to cracking and breakage can be provided.

Further, since the length in the direction along the edge of the outer pressing piece 12b is set larger than that of the inner inserting piece 12a, the inner inserting piece 12a can be smoothly inserted into the back of the

wedges

102 and 103 at the same time. As shown in FIG. 2, the large outer pressing piece 12b can hide many eyelashes 105 of the upper and

lower eyelids

102 and 103 and the roots thereof.

For example, when performing a vitreous injection of an anti-angiogenic agent, a sterile open eyelid device is directly attached to the eye 101 not having a drape attached. By setting the size of the large size, as shown in FIG. 2, many eyebrows 105 that may be contaminated with bacteria and dirt and their roots are wider than in the conventional example shown in FIG. And the injection needle touching the eyelashes 105 can be inserted into the eye to reduce the risk of developing endophthalmitis. In addition, because the size of the outer pressing piece 12b is increased, the upper and

lower ribs

102, 103 can be pressed with a wide surface, so that the pain of the patient is reduced, and an increase in vitreous pressure is induced. It becomes difficult.

In particular, since the length of the outer pressing piece 12b is 16 mm or more and the length of the inner insertion piece 12a is 15 mm or less, the burden on the patient when inserting the inner insertion piece 12a on the back side of the

scissors

102, 103 is reduced. However, it is possible to perform a safe treatment by pressing the eyelashes 105 on the front side of the

eyelids

102 and 103.

Further, as shown in FIG. 1 (d), the dimension Wa in the direction of insertion into the inside of the heel of the inner pressing piece 12a is set smaller than the dimension Wa in the same direction of the outer pressing piece 12b. The burden can be further reduced, and the operability at the time of attachment and detachment can also be improved.

Further, since the arm 14 is formed in a wire shape having a thickness of 1.5 mm or more, a spring force sufficient for opening can be applied to the arm 14 made of resin, and molding of the arm 14 is also easy. it can.

In the above embodiment, the case where polymethyl methacrylate is used as the resin material has been described, but as other materials, polyolefins such as polyethylene and polypropylene, polysulfone, polyphenyl sulfone, polyether polyether ether ketone, polycarbonate, It is also possible to use polyphenyl sulfone or the like. However, when it is used as a disposable type, it is preferable to use polymethyl methacrylate which can be injection-molded from the viewpoint of cost and also as a medical device.

Further, the technical idea of making the dimension of the outer pressing piece 12b larger than the dimension of the inner insertion piece 12a of the wedge pressing portion 12 described above can be applied to the metal opening device shown in FIG. In that respect, the same effect can be obtained even with a metal opener.

The structure of the opening device of embodiment of this invention is shown, (a) is a perspective view, (b) is a top view, (c) is a side view, (d) is a front view, (e) is a (d). It is an enlarged view of Ie part. It is a figure which shows the use condition of the opener. It is a perspective view which shows an example of the conventional metal opener. It is a perspective view which shows another example of the conventional metal opener. It is a figure which shows the use condition of the conventional opener.

DESCRIPTION OF SYMBOLS 10 Opener 12 瞼 holding part 12a inner insertion piece 12b outer holding piece 14 arm 14a both ends 102 upper part 103 lower part

Claims

It has a single U-shaped curved arm so as to have springiness, and two hook holding parts respectively connected to both ends of the arm and hooked to the upper and lower hooks, and the whole is made of resin. An opener, characterized in that it is configured as a one-piece molding and is kept open by the spring repulsive force of the arm.
The wedge pressing portion includes a curved plate having a U-shaped cross section having an inner insertion piece inserted into the inner side of the wedge and an outer pressing piece pressing the outer side of the wedge, and the thickness of the curved plate is the inner insertion piece The opener according to claim 1, characterized in that at least the tip end of the one side of the inner insertion is changed so as to be thinner than a U-shaped curved portion in which the outer holding piece is connected.
The thickness of the curved plate is changed so as to gradually decrease from the U-shaped curved portion in which the inner insertion piece and the outer pressing piece are connected to both tip portions. Opener as described.
The opener according to claim 2 or 3, wherein the arm is formed in a wire shape having a thickness of 1.5 mm or more.
The opener according to any one of claims 2 to 4, wherein the length of the outer pressing piece in the direction along the edge of the hook is set larger than that of the inner insertion piece. .
A length in a direction along an edge of a ridge of the outer pressing piece is set to 16 mm or more, and a length in a direction along an edge of the ridge of the inner insertion piece is set to 15 mm or less The opener according to claim 5.
The opening device according to any one of claims 2 to 6, wherein the dimension of the direction in which the inner insertion piece is inserted into the inner side of the wedge is set smaller than that of the outer pressing piece. .
The opener according to any one of claims 1 to 6, wherein the whole is integrally formed of a thermoplastic resin.