CN116616836A

CN116616836A - Iris expansion device with adjustable it is intraocular

Info

Publication number: CN116616836A
Application number: CN202310260618.0A
Authority: CN
Inventors: 谢平; 范圆媛; 王婧帆; 胡仔仲
Original assignee: Jiangsu Province Hospital First Affiliated Hospital With Nanjing Medical University
Current assignee: Jiangsu Province Hospital First Affiliated Hospital With Nanjing Medical University
Priority date: 2023-03-17
Filing date: 2023-03-17
Publication date: 2023-08-22

Abstract

An intraocular adjustable iris expansion device comprises a support piece and an expansion arm; the support piece is a closed loop structure formed by connecting at least four strip-shaped sheet-shaped support arms end to end, adjacent support arms can be opened and closed in a rotating mode around connecting points, at least one strip-shaped sheet-shaped expansion arm is connected to each support arm, one end of each expansion arm is connected with each support arm, each expansion arm can be opened and closed in a rotating mode around connecting points to be attached to the plane of the support arm, the other end of each expansion arm is an iris hook with a torsion angle with the plane of each expansion arm, and the pupil expansion device is provided with a first working state in which the support arm is contracted inwards and a second working state in which the support arm is expanded outwards. The invention can separate the operation and adjustment of support and expansion, and can protect the pupil and iris morphology of patient to the maximum extent, reduce inflammatory reaction, promote postoperative anatomy and function restoration, reduce risk of iris injury, and has simple structure, convenient and flexible placement and extraction, and shortened operation time.

Description

Iris expansion device with adjustable it is intraocular

Technical Field

The invention belongs to the field of medical appliances, and particularly relates to an intraocular adjustable iris expansion device.

Background

In the medical ophthalmic surgery, in order to fully observe the condition in the eye, the pupil is required to be dilated, but in the surgery process, the pupil is stimulated to shrink, and the stability of the pupil dilation cannot be ensured by using the pupil dilation medicine, and if a patient uses the medicine such as an alpha-adrenergic receptor inhibitor or prostaglandin or the like, or suffers from serious pediatric vitreoretinal diseases such as retinopathy of prematurity, familial exudative vitreoretinopathy, perpetuating original vitreohyperplasia and the like, the effect of the pupil dilation medicine is very weak. When the iris is adhered due to inflammation, trauma, etc., the pupil cannot be dilated even with the use of mydriatic drugs. The condition that the pupil diameter is still smaller than 4mm after the maximum drug treatment due to various pathological factors is called a small pupil, the condition limits the exposure of an intraocular structure, reduces the operation space of an anterior chamber, causes the difficulty of capsulorhexis, nucleus breakage, cortical suction and intraocular lens implantation during cataract surgery, has limited visual field during retinal surgery, and greatly increases the surgical risk. Effective, durable and safe pupil dilation is a key adjustment for ensuring smooth performance of intraocular surgery.

In clinic, the pupil is dilated by dilating the iris through injecting a viscoelastic agent, performing (partial) excision on the iris, performing an iris retractor and the like, but the limitation is obvious. The viscoelastic agent has limited pupil expansion range and needs to be repeatedly injected during anterior chamber operation; the complete or partial excision of iris causes great surgical trauma, severe postoperative inflammatory reaction and permanent loss of tissues to affect visual quality; although the iris retractor is cheap in price, at least four incisions with proper size and position are required to be manufactured on the limbus, time is wasted, the requirement on fine operation of an operator is high, and the extraocular shaft rod placed at the incision is not only unfavorable for cornea flattening (influence on placement of a contact lens and the like) in the operation, but also can limit the operation space of the operator and interfere with the operation vision.

Therefore, the intraocular iris expander is gradually favored, and the currently commercialized iris expander such as Xpand NT, malyugin ring2.0 and the like can stably and permanently dilate the pupil in the operation so as to facilitate the operation field, stabilize the iris plane, reduce the recurrent iris proliferation and adhesion after the operation and do not influence the access of the operation instrument. However, due to the high requirement for materials, the risk of deformation, fracture and dislocation of the expansion ring is increased due to the excessive softness, permanent damage to the iris is easily caused due to the excessive hardness, and the raw materials with elasticity and flexibility are often high in cost. A fixed dilated diameter is also a drawback of such iris dilators, which dilate the pupil to a maximum of 8mm, and excessively strong and unadjustable dilated forces increase the risk of injury to the sphincter of the pupil, tearing of the pupil margin, impeding the anatomy and functional repositioning of the pupil after surgery.

Chinese patent document CN 105188514A discloses an iris expander comprising a single non-metallic multi-segment body that is expandable from a first state to a second state. The second condition defines a larger footprint than the first condition, wherein the body is defined by a plurality of segments connected by living hinges. The iris expander can be introduced into and expanded in a patient's eye with a low profile. Although the single-body nonmetal multistage design adopted by the iris expander disclosed in the patent document can ensure easy operation in the process of introducing the expander into eyes of a patient and reduce the possibility of damaging the iris, the expanded second state is not adjustable, and the problem that the damage to the sphincter of the pupil and the tearing of the pupil margin possibly exist due to the fixed diameter of the expanded pupil can not be solved.

Chinese patent document CN 111345937A discloses an integral type iris expander, including a plurality of expansion sections that are annular evenly distributed, the expansion section has expansion state and contraction state, and fixedly connected with fixed section between two adjacent expansion sections, expansion section and fixed section are the arc structure setting, and a plurality of expansion sections and fixed section make up into annular integral type structure jointly, a plurality of hollow structure's cavity has all been seted up in the expansion section, the passageway has been seted up in the fixed section, and the both ends of passageway respectively with the cavity fixed intercommunication in two adjacent expansion sections, one of them fixedly connected with pipe on the fixed section, and pipe and passageway fixed intercommunication. This integral type iris expander, through setting up expansion section, fixed section, cavity, passageway and pipe, cooperation operation instrument implants the iris expander into the human eye, conveniently pours into gas or liquid through the pipe into in the cavity of expansion section into through the passageway, makes the cavity be in the inflation state to conveniently carry out high-efficient expansion to the pupil. The iris expander disclosed in the above patent document has a complicated structure and requires the use of gas or liquid to expand the cavity. The iris expander is positioned in the eye in the anterior chamber of the eye, the anterior chamber of the eye is in a dome shape, the center height is 2.5-3mm, the edge height is 0.27-0.5mm, and the space is narrow, so the device has the following defects: 1. minimally invasive small incisions (below 3 mm) that cannot pass modern ophthalmic microsurgery access the anterior chamber of the eye; 2. in a narrow space of the anterior chamber of the eye, the expansion section is limited to expand towards the peripheral part of the anterior chamber, and the expansion range is limited; 3. the device has complex structure, high manufacturing material and technical requirements and is difficult to realize.

Disclosure of Invention

The invention aims at the problems existing in the prior art, and provides an intraocular adjustable iris expansion device which can pass through a cornea incision in a contracted state and then be expanded to form, and can also realize the random adjustment of the expansion degree of the iris. The invention has simple structure, easy production and manufacture, convenient and flexible placement, operation and extraction in operation and can effectively reduce the damage to cornea endothelium.

The specific technical scheme of the invention is as follows:

an intraocular adjustable iris expansion device comprises a support piece and an expansion arm; the support piece is a closed loop structure formed by connecting at least four strip-shaped flaky support arms end to end, adjacent support arms can rotate (open and close) around connecting points, each support arm is at least connected with one strip-shaped flaky expansion arm, one end of each expansion arm is connected with the support arm, each expansion arm can rotate (open and close) around the connecting point to be attached to the plane of the support arm, the other end of each expansion arm is an iris hook with a torsion angle with the plane of the expansion arm, and the iris expansion device is provided with a first working state in which the support arm is contracted inwards and a second working state in which the support arm is expanded outwards to form.

When the iris expansion device has a first working state in which the support arms are contracted inwards, the expansion arms are positioned in the outline of the contracted form of the support arms so as to ensure that the iris expansion device has the smallest size and is convenient for operation.

When the iris expansion device is in the second working state that the supporting arms are expanded outwards to form, the iris expansion device is expanded into a polygonal or circular annular structure, each expansion arm freely rotates around the connecting point in the outline of the annular structure, and the iris hook hooks the iris to a proper position.

Preferably, the connection mode between the supporting arms or the connection mode between the expansion arms and the supporting arms is a link, a hinge, a screw joint or a movable riveting, and the combined parts can mutually rotate, further preferably the movable riveting, and further preferably the rivet-free riveting.

Preferably, the connecting part of the adjacent support arms or the connecting part of the expansion arms and the support arms is provided with a damping gasket or a multi-gear limiting piece, so that the support arms or the expansion arms rotate to a certain position under the stress to form a structural form, and the structural form is maintained after the stress is relieved, and the support arms or the expansion arms have certain structural stability and do not deform.

Preferably, the support arm is arc-shaped. More preferably, the sum of all support arm arc central angles is 360. Preferably, the number of the supporting arms is even, more preferably, the number of the supporting arms is 4, and the arc central angle of each supporting arm is 90 °. The support piece is in a contracted state in a narrow 8 shape and in an expanded state in a circular shape. Preferably circular with an outer diameter of 7-8 mm. After the dilating arm is unfolded, the draw hook is close to the inner edge of the supporting arm, and the maximum diameter of the iris (pupil) can be expanded to be close to 6-7mm. This expansion scale has met ophthalmic surgical needs.

Preferably, the head and tail stacking mode of the supporting arms is a position relationship of alternately stacking up and down. The design allows the support arms to expand outwardly to form a loop having a thickness of two support arm sheets rather than the sum of the thicknesses of the plurality of support arms. Further, in the above stacking manner, the expansion arms correspondingly connected to the support arms are in an alternate "lower-upper" relative positional relationship, i.e., the expansion arm on the support arm located "above" is connected to the lower side of the support arm, and the expansion arm on the support arm located "below" is connected to the upper side of the support arm. The design makes the expansion arm fill between the height differences formed by the support arms which are stacked up and down, so as to reduce the overall thickness of the expansion device as much as possible.

Preferably, the torsion angle of the iris hook and the plane of the expansion arm is 90 degrees.

Preferably, the iris hook is a semicircular ring 'C' shape which is convenient for fixing the iris edge.

Preferably, the expansion arms are connected near the connection points of adjacent support arms. This design ensures that there is sufficient space for the expansion arms to fit as closely as possible to the contracted support member in the first operating state.

Preferably, the end of the expansion arm having the iris hook is thinner than the end of the expansion arm connected to the support arm.

Preferably, the width of the supporting arm is 1mm, the widest part of the expanding arm is not wider than 1mm, and the thickness of the supporting arm or the expanding arm is 0.2-0.5mm. Preferably, the support arm and/or the expansion arm is provided with a positioning hole. The position adjusting hole on the expansion arm is positioned at one third of the length of the expansion arm near one end of the iris hook.

In a preferred embodiment, the support member and the expansion member are made of polymethyl methacrylate (polymethyl methacrylate, PMMA) material.

The iris expansion device of the invention is used in a contracted state in combination with a syringe in the prior art, preferably a 3.0mm folding intraocular lens syringe used clinically in the prior art.

The invention has the advantages that:

compared with the prior art, the invention has the beneficial effects that:

1. the iris expansion device in the prior art is of a supporting and expanding integrated structure. According to the iris expansion device, the iris expansion device in the prior art is transformed and split into the support piece and the expansion piece with independent functions, and the split thinking enables the operation of 'support' and 'expansion' to be separated from adjustment, so that the operation is more controllable, and the risk of iris injury is reduced.

2. The invention adopts the design of a plurality of independent expansion arms, is not only suitable for different pupil expansion scale requirements, has universality, and can implement individual iris expansion effect according to different patient characteristics, thereby avoiding the problems of sphincter injury and iris tearing possibly caused by indiscriminate excessive iris expansion. Meanwhile, the invention is suitable for the requirements of operators with different operation levels on pupil dilation, and on the premise of ensuring the operation visual field, the pupil morphology of the patient is protected to the greatest extent, the inflammatory reaction is reduced, the postoperative anatomy and functional restoration are promoted, and the aesthetic requirements of the patient are met.

3. The iris expansion device can stably and continuously expand the iris, and is beneficial to observing and treating peripheral lesions in the intraocular operation; placed in the eye, and reserves the access space of the surgical instrument.

4. The PMMA which is the raw material of the invention is a high molecular polymer, also called acrylic or organic glass, has good elasticity, resistance and flexibility, stably dilates pupils and simultaneously protects fragile eyeball tissues to the greatest extent. PMMA also has the advantages of high transparency, low price, easy machining and the like, and the hard artificial lens prepared by the PMMA is widely applied to ophthalmic surgery at present, has been proved to have excellent eyeball suitability and histocompatibility, and increases the conversion capability of the invention for large-scale production and practical application.

5. The invention adopts a folding thin ring structure, and when in a contracted state, the iris retractor of the expansion arm is folded and hidden in the outer ring structure, thereby avoiding damage to cornea endothelium; the structure is simple, and the preparation is easy; the placement and the taking out are convenient and flexible, so that the operation time is shortened.

6. The invention can stabilize the iris plane and realize the multifunctional use. The support arm and the expansion arm are sheet-shaped on the iris plane after being unfolded in eyes, and can reduce the displacement of the iris during operation, so that the invention can be also applied to the support of the capsular bag during iris prolapse, iris relaxation syndrome during operation, iris cleavage, lens zonula occludens cleavage or subluxation, and the like.

Drawings

The invention is further described below with reference to the accompanying drawings.

Fig. 1 is a schematic view showing a contracted state of embodiment 1 of the present invention.

Fig. 2 is a schematic view showing the structure of the expanded state of embodiment 1 of the present invention.

Fig. 3 is a schematic diagram showing the structure of example 1 of the present invention when the iris is dilated in the eye.

Fig. 4 is a schematic view showing the structure of the expansion arm according to embodiment 1 of the present invention.

Fig. 5 is a schematic diagram of an iris hook structure according to embodiment 1 of the present invention.

Detailed Description

Example 1

An intraocular adjustable iris expansion device comprises a support piece and an expansion arm 2; the support piece is a closed loop structure formed by connecting at least four strip-shaped sheet-shaped support arms 1 end to end, the adjacent support arms 1 can rotate (open and close) around a connecting point, each support arm 1 is at least connected with one strip-shaped sheet-shaped expansion arm 2, one end of each expansion arm 2 is connected with the support arm 1, each expansion arm 2 can rotate (open and close) around the connecting point, the other end of each expansion arm 2 is an iris hook 3 with a torsion angle with the plane of each expansion arm 2, and the pupil expansion device is provided with a first working state in which the support arm 1 is contracted inwards and a second working state in which the support arm 1 is expanded outwards.

The head-to-tail connection of the support arm 1 or the connection mode of the expansion arm 2 and the support arm 1 are linkage, hinging, screw connection or movable riveting, the combined parts can mutually rotate, movable riveting is further preferred, and the adjacent connection part of the support arm 1 or the connection part of the expansion arm 2 and the support arm 1 without rivet riveting is more preferred to be provided with a damping gasket or a multi-gear limiting part, so that the support arm 1 or the expansion arm 2 rotates to a certain position under the stress to form a structural form, and the structural form is maintained after the stress is relieved, has certain structural stability and does not deform.

The support arm 1 is arc-shaped. More preferably, the sum of the arc central angles of all the support arms 1 is 360 °. Preferably, the number of the supporting arms 1 is even, more preferably, the number of the supporting arms 1 is 4, and the arc central angle of each supporting arm 1 is 90 °. The support member is in a contracted state in a narrow 8 shape and in an expanded state in a circular shape. Preferably circular with a diameter of 7-8 mm. After the dilating arm is unfolded, the draw hook is close to the inner edge of the supporting arm, and the maximum diameter of the iris (pupil) can be expanded to be close to 6-7mm. This expansion scale has met ophthalmic surgical needs.

The head and tail stacking mode of the supporting arms 1 is a stacked position relationship of alternately 'up and down'. The design allows the support arms 1 to expand outwardly to form a loop having a thickness of two sheets of support arms 1, rather than the sum of the thicknesses of the plurality of support arms 1. Further, in the above stacking manner of each support arm 1, the expansion arms 2 correspondingly connected to each support arm 1 are in an alternate "lower-upper" relative positional relationship, i.e., the expansion arm 2 on the support arm 1 located "above" is connected below the support arm 1, and the expansion arm 2 on the support arm 1 located "below" is connected above the support arm 1. The design fills the expansion arm 2 between the height differences formed by the support arms 1 stacked up and down so as to reduce the overall thickness of the expansion device as much as possible.

The torsion angle of the iris hook 3 and the plane of the expansion arm 2 is 90 degrees.

The iris hook 3 is a semicircular ring 'C' shape which is convenient for fixing the iris edge.

The expansion arm 2 is connected near the connection point of the adjacent support arm 1. This design ensures that there is sufficient space for the expansion arms 2 to fit as closely as possible to the contracted support in the first operating state.

The end of the expansion arm 2 having the iris hook 3 is thinner than the end of the expansion arm 2 connected to the support arm 1.

Preferably, the width of the supporting arm is 1mm, the widest part of the expanding arm is not wider than 1mm, and the thickness of the supporting arm or the expanding arm is 0.2-0.5mm.

Preferably, the support arm 1 and/or the expansion arm 2 has a positioning hole 4. The positioning hole 4 on the expansion arm 2 is positioned near one third of the length of the expansion arm at one end of the iris hook.

The support member and the expansion member are made of polymethyl methacrylate (polymethyl methacrylate, PMMA) material.

Also included is a 3.0mm folding intraocular lens injector for fitting over the support device in the collapsed state.

When the device is used, the injector is pushed to enable the supporting device in a contracted state to enter the anterior chamber from the limbus incision, after the supporting device is completely entered, the supporting arm 1 is expanded from the first working state to the second working state through the positioning hole 4 by using the positioning hook, and the expansion arm 2 is positioned to the proper position of the iris in the eye expansion in fig. 3, so that the pupil expansion diameter is adjusted. After the support arm 1 is unfolded into a round shape, the outer diameter of the round shape is 8mm, the width of the support arm 1 is 1mm, the inner diameter of the support arm is 7mm, and the draw hook is close to the inner edge of the support arm 1 after the expansion arm 2 is unfolded, so that the maximum diameter of the pupil opening is close to 7mm. The pupil diameter meets the needs of ophthalmic surgery.

In addition to the embodiments described above, other embodiments of the invention are possible. All technical schemes formed by equivalent substitution or equivalent transformation fall within the protection scope of the invention.

Claims

1. An intraocular adjustable iris expansion device comprises a support piece and an expansion arm; the pupil expansion device is characterized in that the support piece is of a closed loop structure formed by connecting at least four strip-shaped sheet-shaped support arms end to end, the adjacent support arms can rotate around connecting points, each support arm is at least connected with one strip-shaped sheet-shaped expansion arm, one end of each expansion arm is connected with the support arm, the expansion arm can rotate around the connecting point to be attached to the plane of the support arm, the other end of each expansion arm is an iris hook with a torsion angle with the plane of the expansion arm, and the pupil expansion device is provided with a first working state in which the support arm is contracted inwards and a second working state in which the support arm is expanded outwards.

2. The stent of claim 1, wherein the means of interconnecting the support arms or the means of interconnecting the stent arms and the support arms comprises a link, a hinge, a screw, a rivet.

3. The expansion device of claim 2, wherein the adjacent support arm connection or the expansion arm to support arm connection has a damping shim or a multi-step stop.

4. The expansion device of claim 1, wherein the support arms are arc-shaped, and the sum of the central angles of all the arc-shaped support arms is 360 degrees; the number of the supporting arms is even.

5. The stent of claim 4, wherein the number of support arms is 4 and the arc-shaped central angle of each support arm is 90 °; the support piece is in a contracted state in a narrow 8 shape and in an expanded state in a circular shape.

6. The stent of claim 5, wherein the circular outer diameter is 7-8mm in diameter, the support arm is 1mm wide, the widest point of the stent is no wider than 1mm, and the thickness of the support arm or stent is 0.2-0.5mm.

7. The stent of claim 1, wherein the support arms are connected end to end in an alternating "up and down" stacked relationship, and the correspondingly connected stent arms on each support arm are in an alternating "down and up" relative relationship.

8. The stent of claim 1, wherein the iris hook is twisted 90 degrees from the plane of the stent arm, the iris hook being "C" shaped.

9. The stent of claim 1, wherein the stent arms are connected near the point of connection of adjacent support arms.

10. An expansion device according to claim 1, wherein preferably the support arm and/or expansion arm has a positioning hole therein; the position adjusting hole on the expansion arm is positioned at one third of the length of the expansion arm near one end of the iris hook.