CN219207666U - Drainage implant adapted to schlemm's canal - Google Patents

Abstract

The utility model provides a drainage implant which is adapted to schlemm's canal, comprising a tubular support, wherein the tubular support can be bent with the curvature of the schlemm's canal, the tubular support is provided with a tubular body and a drainage hole which is formed on the tubular body and penetrates through the thickness of the tubular body, the head part and the tail part of the tubular body are respectively provided with a wedge-shaped or conical end face, and the end face structures of the head part and the tail part of the tubular body are generally consistent. The pipe network-shaped bracket is formed by carving a thin-diameter thin-wall pipe through laser, and then is obtained through electrolytic polishing treatment. After the tubular stent is implanted into Schlemm's canal (Schlemm's canal), aqueous humor flows into the Schlemm's canal of the eye along the implant of the tubular stent structure and into the circulatory system to reduce intraocular pressure and alleviate glaucoma symptoms.

Description

Drainage implant adapted to schlemm's canal

Technical Field

The utility model belongs to the technical field of medical instruments, and particularly relates to a drainage implant suitable for schlemm's canal.

Background

Minimally invasive glaucoma surgery (Micro invasive glaucoma surgery, MIGS) refers to the reduction of ocular pressure to alleviate glaucoma symptoms by improving aqueous outflow through minimally invasive techniques without damaging the patient's sclera and conjunctiva. Although the traditional glaucoma treatment method can effectively reduce intraocular pressure, common problems such as shallow anterior chamber and choroidal separation easily occur in early postoperative period, and complications easily occur in long term. Compared with the traditional operation, the MIGS has the obvious advantages of small wound, definite curative effect, high safety, quick recovery, low complication risk and the like.

CN 206852704U designs a drainage device composed of an equilateral triangle drainage base and two side wings, the side wings are implanted into the cut Schlemm tube during operation to play a permanent supporting role, so that aqueous humor in the Schlemm tube is led out of eyes along the gap between the two side wings and the Schlemm tube, thereby achieving the purpose of reducing intraocular pressure. CN 215606822U proposes a glaucoma drainage implant designed as a hollow arc-shaped tube, and the arc-shaped outer side wall is provided with a barb structure for increasing friction at intervals, so as to increase friction force with the Schlemm tube, thereby increasing stability, avoiding movement, and expecting good long-term treatment effect. CN 111888086A discloses a glaucoma drainage implant and a push injector, wherein the drainage implant is pushed to a Schlemm tube along a guide rail, and the drainage implants disclosed in the Schlemm tube are hollow cylindrical pipelines, and a friction-increasing structure is attached to the periphery of the drainage implant. CN 113288580A discloses an aqueous humor drainage device for implanting into eyes of glaucoma patients, which is an integral tubular device with an equal-diameter drainage channel or a variable-diameter drainage channel formed therein, and is made of acrylic materials, and an auxiliary fixing structure with a bulge or a recess is arranged on the outer side wall of the drainage device. The drainage implant acts on the Schlemm tube, so that the stability problem after implantation is considered, but the reciprocating operation in the operation is considered less, and only when the initial release position is not timely, the retrieval and the replacement are needed to increase the trauma and the operation difficulty; meanwhile, in function realization, the design of the patent document is to be intentionally implanted into the Schlemm tube to promote aqueous humor to form aqueous humor drainage in a hollow channel of the implant, but the expansion capacity of the implant to the Schlemm tube is not considered, and meanwhile, the drainage effect of the inner side wall and the outer side wall of the implant is not given to the design.

Disclosure of Invention

In view of the above problems, the present utility model provides a drainage implant adapted to Schlemm's canal, which fully considers the expansion capacity of the implant itself to the Schlemm's canal and expands the drainage capacity of the inner and outer sidewalls of the implant.

The utility model aims at realizing the following technical scheme:

the utility model provides a drainage implant which is adapted to schlemm's canal, comprising a tubular support, wherein the tubular support can be bent with the curvature of the schlemm's canal, the tubular support is provided with a tubular body and a drainage hole which is formed on the side wall of the tubular body and penetrates through the wall thickness of the tubular body, the aperture sizes of the drainage hole on the head end face and the tail end face are adapted to a conveying system of the implant, and the implant is conveniently released or picked up and reset in time; the tubular body is provided with a diversion hole which axially penetrates through the head end face and the tail end face, a wedge-shaped or conical end face is formed on the head end face and/or the tail end face of the tubular body, and the head end face and the tail end face of the tubular body are consistent in structure. The end face is of a wedge-shaped or conical pipe sleeve structure, so that the canal is conveniently penetrated into Schlemm canal (Schlemm pipe) during implantation, two ends are consistent, the implant is conveniently released and untimely temporary grabbing and adjusting are performed, and the pipe sleeve structure can be used for enhancing aqueous humor drainage on two sides. Preferably, the pipe network bracket is obtained by carving a thin-diameter thin-wall pipe through laser and then performing electrolytic polishing treatment. After the tubular stent is implanted into Schlemm's canal (Schlemm's canal), aqueous humor flows into the Schlemm's canal of the eye along the implant of the tubular stent structure and into the circulatory system to reduce intraocular pressure and alleviate glaucoma symptoms.

Further, the drainage hole comprises an inner drainage hole formed on the inner side wall of the tubular body facing the curvature center and an outer drainage hole formed on the outer side wall of the tubular body far away from the curvature center, and the inner drainage hole and the outer drainage hole are arranged in a staggered manner in the axial direction. A plurality of inner drainage holes and outer drainage holes are usually arranged, so that the comprehensive flow of the aqueous humor drainage system is conveniently increased.

Further, a plurality of inner drainage holes are formed on the inner side wall of the tubular body at equal intervals, and the inner drainage holes have oval holes or waist-shaped hole structures.

Further, the outer drainage hole comprises a first drainage hole and a second drainage hole, the first drainage hole is provided with an oval or waist-shaped hole structure, and the head part and the tail part of the tubular body are respectively provided with a first drainage hole; the lateral wall at the middle part of the tubular body comprises a first lateral wall and a second lateral wall, the first lateral wall is provided with a peak valley-shaped outer edge, the first lateral wall is circumferentially curled to enable a peak of the first lateral wall to be abutted to the end face of the second lateral wall or form a support at the inner wall of the second lateral wall in an inclusion mode, a second drainage hole is formed between the trough of the first lateral wall and the second lateral wall, and at least two second drainage holes are formed at the middle part of the tubular body.

Preferably, the second outer side wall also has a peak valley-shaped outer edge, and the peak of the first outer side wall is abutted against the peak end surface of the second outer side wall or included on the peak inner wall of the second outer side wall, and a second drainage hole is correspondingly formed between the trough of the first outer side wall and the trough of the second outer side wall. Preferably, the first outer side wall and the second outer side wall are arranged in a substantially axisymmetric manner, and the wave crest of the first outer side wall is included on the wave crest inner wall of the second outer side wall, so that the effect of supporting the Schlemm tube can be achieved, the natural width of the Schlemm tube is enlarged, the drainage effect is enhanced, the application range of the intraocular implant with the tubular support structure can be enlarged, and the intraocular implant with the tubular support structure is not only suitable for open-angle glaucoma patients, but also can benefit closed-angle glaucoma patients.

Further, the pipe network-shaped bracket is made of medical metal materials, for example, medical stainless steel, medical titanium and titanium alloy, medical zirconium and zirconium alloy and the like can be adopted.

Preferably, the pipe network bracket is prepared from shape memory alloy; preferably, the pipe network-shaped bracket is prepared from medical nickel-titanium alloy, and because the material has good biocompatibility, shape memory effect and superelasticity, good plasticity effect of an arc structure, is implanted into a Schlemm pipe, is permanently existing, is not easy to deform, and has no toxic or side effect.

Further, the outer diameter of the pipe network-shaped support is 0.25-0.35 mm, the whole axial extension length of the pipe network-shaped support is 6.5-9.5 mm, and the bending radian is 65-105 degrees. The arc-shaped structure can endow the implant with larger span and wider coverage range, ensure that sufficient aqueous humor enters the circulatory system of the eye and is drained and delivered, and effectively reduce intraocular pressure.

Further, the tubular stent is subjected to surface treatment by adopting hydrophilic heparin, so that the inflammatory effect after implantation is slowed down, the lubricity of the product is increased, and the surgical implantation is facilitated.

The utility model has the beneficial effects that:

(1) The middle part of the pipe network-shaped support forms a pipe network in an inclusion mode, so that the radial expansion size of the pipe network-shaped support can be adjusted, the function of supporting the Schlemm pipe is achieved, the natural width of the Schlemm pipe is enlarged, the drainage effect is enhanced, meanwhile, the application range of the intraocular implant in the pipe network-shaped support structure can be enlarged, and the pipe network-shaped support is not only suitable for open-angle glaucoma patients, but also benefit from closed-angle glaucoma patients;

(2) The head end and the tail end of the pipe network-shaped support form a conical or wedge-shaped sleeve structure, so that the pipe network-shaped support is convenient to penetrate into a Schlemm pipe during implantation, the two ends are consistent, the implant is convenient to load into a conveying system, meanwhile, the implant is convenient to release and untimely temporary grabbing and adjusting when being positioned, and the sleeve structure can be used for enhancing drainage of aqueous humor at the two sides.

(3) The tubular net-shaped bracket is preferably made of biomedical NiTi alloy materials, has good biocompatibility and superelasticity, has a stable arc-shaped structure obtained by molding, is endowed with a larger span and wider coverage range, can ensure that sufficient aqueous humor enters the circulatory system of eyes, and effectively reduces intraocular pressure by drainage output; the surface of the bracket is treated by hydrophilic heparin, so that the inflammatory action after implantation can be relieved, the lubricity of the instrument is increased, and the operation of operators is facilitated.

Drawings

FIG. 1 is a schematic view of a drainage implant of the present utility model adapted for use in schlemm's canal;

fig. 2 is a schematic axial sectional view of fig. 1.

Detailed Description

The technical solutions of the preferred embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model. It will be apparent that the described embodiments are only some, but not all, embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to fall within the scope of the utility model.

The embodiment provides a drainage implant matched with schlemm, which comprises a pipe network-shaped support, as shown in fig. 1 and 2, wherein the pipe network-shaped support can be bent with the curvature matched with schlemm, the outer diameter of the pipe network-shaped support is 0.25-0.35 mm, the whole axial extension length of the pipe network-shaped support is 6.5-9.5 mm, the bending radian is 65-105 degrees, the pipe network-shaped support is provided with a tubular body and a drainage hole formed on the side wall of the tubular body and penetrating through the wall thickness of the tubular body, and the aperture of the drainage hole on the head end face and the tail end face is matched with a conveying system of the implant, so that the implant is conveniently released or picked up and reset in time; the tubular body is provided with a diversion hole which axially penetrates through the head end face and the tail end face, the head end face 111 and the tail end face 131 of the tubular body are respectively formed with a wedge-shaped or conical head end face and a conical tail end face 130, and the head end face and the tail end face of the tubular body are generally consistent in structure. The end face is of a wedge-shaped or conical pipe sleeve structure, so that the canal is conveniently penetrated into Schlemm canal (Schlemm pipe) during implantation, two ends are consistent, the implant is conveniently released and untimely temporary grabbing and adjusting are performed, and the pipe sleeve structure can be used for enhancing aqueous humor drainage on two sides. Preferably, the pipe network bracket is obtained by carving a thin-diameter thin-wall pipe through laser and then performing electrolytic polishing treatment. After the tubular stent is implanted into Schlemm's canal (Schlemm's canal), aqueous humor flows into the Schlemm's canal of the eye along the implant of the tubular stent structure and into the circulatory system to reduce intraocular pressure and alleviate glaucoma symptoms.

In the illustrated embodiment, the drainage apertures include an inner drainage aperture 103 formed on an inner sidewall 100n of the tubular body facing the center of curvature and an outer drainage aperture formed on an outer sidewall 100w of the tubular body facing away from the center of curvature, the outer drainage apertures including a first drainage aperture 101f and a second drainage aperture 101k, the first drainage aperture 101f having an oval or kidney-shaped aperture-like structure, the head 110 and tail 130 of the tubular body each being formed with one first drainage aperture 101f; the outer side wall of the middle part 120 of the tubular body comprises a first outer side wall 121 and a second outer side wall 122, the first outer side wall 121 and the second outer side wall 122 are respectively provided with a peak-valley-shaped outer edge, as shown in fig. 1, a first peak 121a and a first valley 121b are formed on the first outer side wall 121, a second peak 122a and a second valley 122b are formed on the second outer side wall 122, the first peak 121a of the first outer side wall is included on the inner wall of the second peak 122a of the second outer side wall, a second drainage hole 101k is formed at a corresponding hole part between the first valley 122b of the first outer side wall and the second valley 122b of the second outer side wall, and at least two second drainage holes are formed on the outer side wall of the middle part 120 of the tubular body. Preferably, a plurality of inner drainage holes and outer drainage holes are generally arranged, and the inner drainage holes 103 and the outer drainage holes form an offset arrangement structure in the axial direction, so that the comprehensive flow rate of the aqueous humor drainage system is increased. The first lateral wall and the second lateral wall set up with being the mode of axisymmetry in general, adopt the crest inclusion of first lateral wall on the crest inner wall of second lateral wall simultaneously structure, can play the effect that supports Schlemm pipe like this, can enlarge the natural width of Schlemm pipe, strengthen drainage effect, can also enlarge the application scope of this tubular network form support structure intraocular implant simultaneously, not only is applicable to open angle glaucoma patient, and closed angle glaucoma patient also can benefit therefrom.

In other embodiments, the first peak 121a of the first outer sidewall may abut against the end surface of the second peak 122a of the second outer sidewall, or the first peak 121a and the second peak 122a may not contact at all, so that all the second drainage holes 101k form a through connection structure.

In other embodiments, the second outer sidewall 122 may not adopt a peak-valley structure, and the first outer sidewall may be curled circumferentially so that the first peak 121a thereof abuts against the end surface of the second outer sidewall 122 or is wrapped around the inner wall of the second outer sidewall to form a support, or a second drainage hole may be formed between the trough of the first outer sidewall and the second sidewall,

in a preferred embodiment, a plurality of inner drainage holes are formed on the inner side wall 100n of the tubular body at equal intervals, the inner drainage holes 103 have an elliptical or waist-shaped hole structure, and adjacent inner drainage holes are not communicated on the inner side wall and are respectively and independently closed hole structures.

In a preferred embodiment, the tubular stent is made of medical metal materials, for example, medical stainless steel, medical titanium and titanium alloy, medical zirconium and zirconium alloy, and the like. In a more preferred embodiment, the tubular stent is made of a shape memory alloy; preferably, the pipe network-shaped bracket is prepared from medical nickel-titanium alloy, and because the material has good biocompatibility, shape memory effect and superelasticity, good plasticity effect of an arc structure, is implanted into a Schlemm pipe, is permanently existing, is not easy to deform, and has no toxic or side effect.

In a preferred embodiment, the external diameter of the pipe network-shaped support is 0.25-0.35 mm, the whole axial extension length of the pipe network-shaped support is 6.5-9.5 mm, and the bending radian is 65-105 degrees. The arc-shaped structure can endow the implant with larger span and wider coverage range, ensure that sufficient aqueous humor enters the circulatory system of the eye and is drained and delivered, and effectively reduce intraocular pressure. In a preferred embodiment, the inner drainage hole 103 is an oval hole, the length diameter is 0.8-1.2 mm, the shortest distance that the inner drainage hole 103 near the head 110 extends towards the head end face along the axial direction of the inner side wall 100n is 0.8-1.5 mm, and the minimum distance that the inner drainage hole near the tail 130 extends towards the tail end face 131 along the axial direction of the inner side wall 100n is 0.8-1.5 mm; the first drainage hole 101f is also an elliptical hole, and the long diameter is 0.6-1.0 mm; the shortest distance that the first drainage hole 101f near the head 110 extends along the axial direction of the outer side wall 100w toward the head end face 111 is 0.2-0.6 mm, and the shortest distance that the first drainage hole 101f near the tail 130 extends along the axial direction of the outer side wall 100w toward the tail end face is 0.2-0.6 mm.

In a preferred embodiment, the tubular stent is surface treated with hydrophilic heparin. The inflammation effect after implantation is slowed down, the lubricity of the product is increased, and the surgical implantation is facilitated.

Finally, it is noted that the above-mentioned preferred embodiments illustrate rather than limit the utility model, and that, although the utility model has been described in detail with reference to the above-mentioned preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the utility model as defined by the appended claims; the dimensions in the drawings and the embodiments are irrelevant to specific objects, are not used for limiting the protection scope of the utility model, and the objects can be selected and changed according to actual needs.

Claims (10)

1. The drainage implant is characterized by comprising a pipe net-shaped bracket, wherein the pipe net-shaped bracket can be bent with the curvature of the adaptive schlemm, the pipe net-shaped bracket is provided with a tubular body and a drainage hole which is formed on the side wall of the tubular body and penetrates through the wall thickness of the tubular body, and the tubular body is provided with a diversion hole which axially penetrates through the head end face and the tail end face; the drainage holes comprise inner drainage holes formed on the inner side wall of the tubular body facing the curvature center and outer drainage holes formed on the outer side wall of the tubular body far away from the curvature center, and the inner drainage holes and the outer drainage holes are arranged in a staggered mode in the axial direction.

2. A drainage implant adapted for use in schlemm's canal according to claim 1, wherein the tubular body has a wedge-shaped or tapered end surface formed on the cephalad and/or caudal end surfaces.

3. A drainage implant adapted for use in schlemm's canal according to claim 1, wherein a plurality of inner drainage holes are formed at equal intervals on the inner side wall of the tubular body, the inner drainage holes having an oval or waist-shaped hole structure.

4. The drainage implant of claim 1, wherein the outer drainage hole comprises a first drainage hole and a second drainage hole, the first drainage hole has an oval or waist-shaped hole structure, and a first drainage hole is formed at the head and tail of the tubular body respectively; the lateral wall at the middle part of the tubular body comprises a first lateral wall and a second lateral wall, the first lateral wall is provided with a peak valley-shaped outer edge, the first lateral wall is circumferentially curled to enable a peak of the first lateral wall to be abutted to the end face of the second lateral wall or form a support at the inner wall of the second lateral wall in an inclusion mode, a second drainage hole is formed between the trough of the first lateral wall and the second lateral wall, and at least two second drainage holes are formed at the middle part of the tubular body.

5. The drainage implant of claim 4, wherein the second outer sidewall also has a peak-valley-shaped outer edge, and the peak of the first outer sidewall abuts against the peak end surface of the second outer sidewall or is included on the peak inner wall of the second outer sidewall, and a second drainage hole is correspondingly formed between the trough of the first outer sidewall and the trough of the second outer sidewall.

6. The drainage implant adapted to schlemm's canal according to any one of claims 1 to 5, wherein the tubular stent is made of a medical metal material.

7. The drainage implant of claim 6, wherein the lattice scaffold is made of a shape memory alloy.

8. The drainage implant adapted to be used in schlemm's canal according to claim 7, wherein the tubular stent is made of medical nickel-titanium alloy.

9. The drainage implant adapted to schlemm's canal according to any one of claims 1 to 5, wherein the outer diameter of the tubular support is 0.25 to 0.35mm, the axial extension length of the tubular support is 6.5 to 9.5mm, and the bending radian is 65 to 105 °.

10. A drainage implant adapted for use in schlemm's canal according to any one of claims 1-5, wherein said tubular scaffold is surface treated with hydrophilic heparin.

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