Eye implantation tube
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to an ocular implant tube.
Background
The eye includes an anterior chamber between the cornea and the iris, the lens, which is filled with a fluid called aqueous humor. In a normal human eye, aqueous humor is produced by the ciliary body behind the iris at a constant rate (typically about 2.2 to 2.7 microliters per minute), flows between the lens and the iris in a conventional outflow pathway, and is then expelled through the trabecular meshwork and returned to the circulatory system.
The intraocular pressure to maintain such outflow from the normal eye is often maintained in the range of 10mmHg to 20 mmHg. However, IOP associated with cardiac cycles, blinks, daytime activity, and other causes may vary significantly. If there is a blockage in the trabecular meshwork fluid outflow path, this will result in excessive fluid accumulation in the eye and subsequent elevation of IOP to a value always greater than about 18 mmHg. In some cases, IOP may be as high as 50mmHg or greater. Over time, this pressure increase causes irreversible damage to the optic nerve and leads to vision loss.
The treatment methods commonly used at present are as follows: drug therapy, laser trabeculoplasty, trabeculectomy, and intraocular drainage implant methods.
While in cases where other treatments have been ineffective, intraocular drainage implant methods are most commonly used, these implants include drainage devices, which are inserted into the eye during surgery so that aqueous humor can drain through a drainage pathway and leave the anterior chamber.
The existing ocular implant cannot effectively meet the effective coordination of the supporting effect and the flow guiding effect during implantation.
Disclosure of Invention
The invention aims to provide an ocular implant which can effectively improve the supporting effect and the effective coordination of the flow guiding effect of an implant body.
The technical scheme is as follows:
an ocular implant tube comprises an implant tube body,
the implant tube body is longitudinally arranged, the front end of the implant tube body forms an advancing end, and the rear end of the implant tube body forms a force application end;
the implantation tube body is hollow to form a fluid channel;
the tube wall of the implantation tube body comprises a connecting body and hollow cavities positioned between the connecting bodies, and the hollow cavities are communicated with the fluid channel;
the projection area of the hollowed cavity on the pipe wall is smaller than the projection area of the connector on the pipe wall;
the implant tube body is curved in an arc shape, the outer diameter of the implant tube body is 0.25-0.4 mm, and the tube wall thickness is 0.01-0.2 mm.
In one embodiment, the implant body is distributed about one sixth to one third of the overall circular arc with respect to its center of curvature in a natural state.
In one embodiment, the connector comprises a first main matrix and a second main matrix in a first direction, and a third main matrix and a fourth main matrix in a second direction;
the first main matrix, the second main matrix, the third main matrix and the fourth main matrix extend towards the first end of the implantation tube body to form two first connecting arms, and the first main matrix, the second main matrix, the third main matrix and the fourth main matrix extend towards the second end of the implantation tube body to form two second connecting arms;
the first connecting arms of the first main matrix and the second main matrix are connected with the second connecting arms of the third main matrix and the fourth main matrix; the second connecting arms of the first main matrix and the second main matrix are connected with the first connecting arms of the third main matrix and the fourth main matrix.
In one embodiment, the two first connecting arms of the first main base body are respectively connected with the second connecting arms on the same side of the third main base body and the fourth main base body;
the two second connecting arms of the first main matrix are respectively connected with the first connecting arms on the same side of the third main matrix and the fourth main matrix.
In one embodiment, at least one of the first connecting arm and the second connecting arm is provided with a bending buffer section.
In one embodiment, the bending buffer section is located between the first connecting arms of the first and second main substrates and the second connecting arms of the third and fourth main substrates.
In one embodiment, the first main matrix, the third main matrix, the second main matrix, and the fourth main matrix are sequentially disposed along a circumferential direction of the implant tube.
In one embodiment, the connecting body is provided with a plurality of main matrixes, the plurality of main matrixes are uniformly staggered along different circumferential positions and different axial positions of the implantation tube body, and each two adjacent main matrixes are connected through a connecting arm; at least part of the connecting arms are provided with bending buffer sections, and gaps are reserved between the two bending buffer sections in different circumferential directions.
In one embodiment, the implant body has at least a first reference surface and a second reference surface, the first reference surface being offset relative to the second reference surface, the bending flexibility of the implant body on the first reference surface being approximately the same as the bending flexibility of the implant body on the second reference surface.
In one embodiment, the bending flexibility of the implant body on the first reference surface is equal to the bending flexibility of the implant body on the second reference surface.
In one embodiment, the first datum plane is perpendicular with respect to the second datum plane.
In one embodiment, the first datum plane is located in a plane in which the arcuately curved implant body is located.
In one embodiment, on the cross section of the implant tube body, the hollow cavity and the connector on the first side of the first reference surface correspond to the hollow cavity and the connector on the second side of the first reference surface, and the hollow cavity and the connector on the first side of the second reference surface correspond to the hollow cavity and the connector on the second side of the second reference surface.
In one embodiment, the partial areas of the hollow cavity on the first reference surface are uniformly spaced from each other, and the partial areas of the hollow cavity on the second reference surface are uniformly spaced from each other.
A guiding inclined plane is formed at the front end of the advancing end, and a force application notch is arranged on the force application end.
The technical scheme provided by the invention has the following advantages and effects:
the ocular implant is of a tube body structure, the outer diameter of the implant tube body is 0.25-0.4 mm, the implant tube body is of an arc-shaped bent shape, the implant tube body can be matched with the physiological characteristics of eyes, the inside of the implant tube body is hollow to form a fluid channel, the tube wall of the implant tube body comprises a connector and a hollow cavity, after the ocular implant is implanted into the eyes of a human body, aqueous humor can be effectively introduced into the fluid channel through the hollow cavity, and the aqueous humor is discharged out of the anterior chamber through the fluid channel of the implant tube body, so that the balance of the hydraulic pressure inside and outside the anterior chamber is achieved; the projection area of the hollowed cavity on the pipe wall is smaller than that of the connector on the pipe wall, and the support strength of the implanted pipe body is effectively ensured on the premise of achieving drainage of aqueous humor; an advancing end is formed at the front end of the implantation tube body, a force application end is formed at the rear end of the implantation tube body, and when an implantation operation is performed, force is applied to the force application end so as to push the advancing end to advance in the front end direction, and the implantation tube body is implanted into the anterior ocular segment.
Drawings
FIG. 1 is a block diagram of a first direction of an ocular implant according to an embodiment of the present invention;
FIG. 2 is an enlarged view at A in FIG. 1;
FIG. 3 is an enlarged view of a portion of FIG. 2;
FIG. 4 is a block diagram of a second orientation of an ocular implant according to an embodiment of the present invention;
FIG. 5 is an enlarged view at B in FIG. 4;
FIG. 6 is an enlarged view of a portion of FIG. 5;
FIG. 7 is a block diagram of a third orientation of an ocular implant according to an embodiment of the present invention;
FIG. 8 is an enlarged view of FIG. 7 at C;
FIG. 9 is an enlarged view of a portion of FIG. 8;
reference numerals illustrate:
11. a first reference surface, 12, a second reference surface,
21. advancing end, 211, guiding inclined plane, 22, force application end, 221, force application notch, 23, fluid channel, 24, hollow cavity,
30. the connecting body 311, the first main matrix, 312, the second main matrix, 313, the third main matrix, 314, the fourth main matrix, 321, the first connecting arm, 322, the second connecting arm, 323, the first bending buffer section, 324, the second bending buffer section, 325, the inner arc edge, 3261, the first inner straight edge, 3262, the second inner straight edge, 330 and the deformation gap.
Detailed Description
In order that the invention may be readily understood, a more particular description of specific embodiments thereof will be rendered by reference to specific embodiments that are illustrated in the appended drawings.
As used herein, the terms "first and second …" are used merely to distinguish between names and not to represent a particular number or order unless otherwise specified or defined.
The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items, unless specifically stated or otherwise defined.
The term "fixed" or "connected" as used herein may be directly fixed or connected to an element, or indirectly fixed or connected to an element.
As shown in fig. 1 to 9, the ocular implant comprises an implant body which is longitudinally arranged, wherein the front end of the implant body forms an advancing end 21, and the rear end of the implant body forms a force application end 22; the interior of the implant tube body is hollow to form a fluid channel 23; the wall of the implantation tube body comprises a connecting body 30 and hollow cavities 24 positioned between the connecting bodies 30, and the hollow cavities 24 are communicated with the fluid channel 23; the projection area of the hollow cavity 24 on the pipe wall is smaller than the projection area of the connecting body 30 on the pipe wall; the implant tube body is curved in an arc shape, the outer diameter of the implant tube body is 0.25-0.4 mm, and the tube wall thickness is 0.01-0.2 mm.
The ocular implant is of a tube body structure, the outer diameter of the implant tube body is 0.25-0.4 mm, the implant tube body is of an arc-shaped curved shape, the implant tube body can be matched with the physiological characteristics of eyes, the inside of the implant tube body is hollow to form a fluid channel 23, the tube wall of the implant tube body comprises a connector 30 and a hollow cavity 24, after the ocular implant is implanted into the eyes of a human body, aqueous humor can effectively enter the fluid channel 23 through a hollow cavity and is discharged out of the anterior chamber through the fluid channel 23 of the implant tube body, and the balance of the hydraulic pressure inside and outside the anterior chamber is achieved; the projection area of the hollow cavity 24 on the pipe wall is smaller than that of the connecting body 30 on the pipe wall, and on the premise of achieving drainage of aqueous humor, the support strength of the implanted pipe body is effectively ensured; an advancing tip 21 is formed at the front end of the implant tube body, and a biasing tip 22 is formed at the rear end thereof, and when the implantation operation is performed, the biasing tip 22 is biased so as to push the advancing tip 21 forward, and the implant tube body is implanted in the anterior ocular segment.
As shown in fig. 1 and 4, in the present embodiment, the implant body is distributed about one quarter of an overall circular arc with respect to the center of curvature thereof in a natural state. After the eye implantation tube is implanted into eyes of a human body, a diversion effect can be achieved on a part of areas of an anterior chamber of the eyes of the human body, and if the areas needing diversion are larger, the length of the eye implantation tube can be correspondingly increased, or a plurality of eye implantation tubes are adopted.
In order to facilitate the accurate implantation of the ocular implant in the present embodiment into the human eye, in this embodiment, bending flexibility of the implant body in several directions is ensured as much as possible, and specifically, the implant body has a first reference surface 11 and a second reference surface 12, in this embodiment, the first reference surface 11 is located in a plane where the implant body is curved in an arc shape, the second reference surface 12 is a longitudinal section of the implant body, the first reference surface 11 is perpendicular to the second reference surface 12, bending flexibility of the implant body on the first reference surface 11 is close to bending flexibility of the implant body on the second reference surface 12, preferably, bending flexibility of the implant body on the first reference surface 11 is equal to bending flexibility of the implant body on the second reference surface 12, and the flexibility of the implant body can be realized by adopting a structure of the present embodiment, and can be realized by adopting different structures and different rigid materials. The first reference surface 11 is shown in fig. 4, in which the first reference surface 11 is curved in an arc shape and perpendicular to the paper surface shown in fig. 4; the first reference surface 11 is shown in fig. 7, in which the first reference surface 11 is planar and perpendicular to the paper surface shown in fig. 7.
In order to ensure the bending flexibility requirements of the implant body in different directions, the aqueous humor guiding effect of the implant body and the supporting effect of the implant body, the refinement structure of the implant body of this embodiment may be shown in fig. 3, fig. 6 and fig. 9.
The connector 30 includes a first main body 311 and a second main body 312 in a first direction, and a third main body 313 and a fourth main body 314 in a second direction; the first main body 311, the third main body 313, the second main body 312, and the fourth main body 314 are sequentially arranged along the circumferential direction of the implant. In this embodiment, the first direction is substantially parallel to the direction of the second reference surface 12, and the second direction is substantially parallel to the first reference surface 11.
The connecting body 30 is provided with a plurality of main matrixes which are uniformly staggered along different circumferential positions and different axial positions of the implantation tube body, and each two adjacent main matrixes are connected through a connecting arm; at least part of the connecting arms are provided with bending buffer sections, and gaps are reserved between the two bending buffer sections in different circumferential directions. The following is a detailed structural description of the connector 30:
the first main body 311, the second main body 312, the third main body 313 and the fourth main body 314 extend towards the first end of the implant body to form two first connecting arms 321, and the first main body 311, the second main body 312, the third main body 313 and the fourth main body 314 extend towards the second end of the implant body to form two second connecting arms 322;
the first connection arms 321 of the first and second main substrates 311, 312 are connected to the second connection arms 322 of the third and fourth main substrates 313, 314; the second connecting arms 322 of the first and second main substrates 311, 312 are connected to the first connecting arms 321 of the third and fourth main substrates 313, 314; the method comprises the following steps:
the two first connecting arms 321 of the first main body 311 are respectively connected with the second connecting arms 322 on the same side of the third main body 313 and the fourth main body 314; the two second connecting arms 322 of the first main body 311 are respectively connected with the first connecting arms 321 on the same side of the third main body 313 and the fourth main body 314. The two first connecting arms 321 of the second main body 312 are respectively connected with the second connecting arms 322 on the same side of the third main body 313 and the fourth main body 314; the two second connection arms 322 of the second main body 312 are connected to the first connection arms 321 on the same side of the third main body 313 and the fourth main body 314, respectively.
The first connection arms 321 of the first main body 311 and the second main body 312 are respectively provided with a first bending buffer section 323, and the second connection arms 322 of the third main body 313 and the fourth main body 314 are respectively provided with a second bending buffer section 324; of the bending buffer sections of each of the adjacent first main body 311, second main body 312, third main body 313, and fourth main body 314, a first bending buffer section 323 of the first main body 311 is abutted with a first second bending buffer section 324 of the fourth main body 314, a second first bending buffer section 323 of the first main body 311 is abutted with a first second bending buffer section 324 of the third main body 313, a first bending buffer section 323 of the second main body 312 is abutted with a second bending buffer section 324 of the third main body 313, and a second first bending buffer section 323 of the second main body 312 is abutted with a second bending buffer section 324 of the fourth main body 314; in the first bending buffer section 323 and the second bending buffer section 324, which are abutted against each other, the bending directions are opposite, a first inner straight edge 3261 and a second inner straight edge 3262 are formed on the back sides of the first bending buffer section 323 and the second bending buffer section 324, and a deformation gap 330 is formed between the first inner straight edge 3261 and the second inner straight edge 3262.
The connection structure of the first main matrix 311, the second main matrix 312, the third main matrix 313 and the fourth main matrix 314 can make the whole implant body have a net structure, so that the requirements of aqueous humor diversion and the requirements of the whole support of the implant body and the bending flexibility of the implant body in all directions can be met.
The first bending buffer section 323 and the second bending buffer section 324 can enable the implant tube body to be deformed more conveniently when being bent, in the deformation process, if the implant tube body is bent or deformed, a certain deformation space of the whole implant tube body can be ensured due to the existence of the deformation gap 330, and on the other hand, when the implant tube body is implanted or after the implant tube body is implanted, if the deformation of the implant tube body exceeds a certain range, the first inner straight edge 3261 and the second inner straight edge 3262 can limit further bending deformation.
As shown in fig. 3, 6 and 9, the inner arc edges 325 are formed between the two first connecting arms 321 and between the two second connecting arms 322 on the first main body 311, the second main body 312, the third main body 313 and the fourth main body 314, so that when the implant tube body is bent and deformed, the tube wall can be prevented from being greatly distorted.
In this embodiment, on the cross section of the implant tube, the hollow cavity 24 and the connecting body 30 located on the first side of the first reference surface 11 correspond to the hollow cavity 24 and the connecting body 30 located on the second side of the first reference surface 11, and the hollow cavity 24 and the connecting body 30 located on the first side of the second reference surface 12 correspond to the hollow cavity 24 and the connecting body 30 located on the second side of the second reference surface 12. The partial areas of the hollow cavity 24 on the first reference surface 11 are uniformly spaced from each other, and the partial areas of the hollow cavity 24 on the second reference surface 12 are uniformly spaced from each other. The structure can effectively ensure that the flexibility of the implanted tube body in all directions is basically consistent, and avoid difficult implantation caused by the fact that the local bending flexibility of the implanted tube body is not caused, or poor flow guide caused by different local supporting rigidity. It will be appreciated that the foregoing "corresponding", "uniform spacing" does not require specific stringent dimensional requirements, as the body of the implant body is in a curved state and certain tolerances or offsets are allowed for product manufacturing tolerances.
A guide slope 211 is formed at the front end of the advancing end 21, and a biasing notch 221 is provided at the biasing end 22. During implantation, the front end of the implantation tool can be clamped into the force application notch 221, and the guide inclined surface 211 at the front end can guide the implantation of the implantation tube body.
In this embodiment, the first main body 311, the second main body 312, the third main body 313, the fourth main body 314, the first connecting arm 321 and the second connecting arm 322 thereof are integrally formed, and the material thereof can be metal, polymer material or biological material for surgical implantation, wherein the metal includes but is not limited to titanium alloy, magnesium alloy, nickel-titanium alloy, tantalum alloy, preferably nickel-titanium alloy; the high polymer material comprises silica gel or polylactic acid PLGA; biological materials include animal-derived tissue, human-derived tissue, purified collagen or recombinant collagen.
It will be appreciated that in this embodiment, the outer diameter of the implant tube body is 0.25 mm to 0.4 mm, and the tube wall thickness is 0.01 mm to 0.2 mm, and when the corresponding outer diameter dimension and tube wall thickness dimension are adopted, the necessary optimization and coordination of the dimensions are required to be satisfied, for example: at a wall thickness of 0.15 mm, it is not possible to use 0.25 mm for its outside diameter, which should be at least 0.3 mm or more, taking into account the necessary dimensions of its fluid passage.
The above examples are also not an exhaustive list based on the invention, and there may be a number of other embodiments not listed. Any substitutions and modifications made without departing from the spirit of the invention are within the scope of the invention.