WO2023237127A1

WO2023237127A1 - Ocular implant catheter

Info

Publication number: WO2023237127A1
Application number: PCT/CN2023/105132
Authority: WO
Inventors: 何海娜; 罗锦荣; 吴有陵; 林永亮; 刘艳丽; 胡楚龙; 范文婷
Original assignee: 健诺维(成都)生物科技有限公司
Priority date: 2022-06-10
Filing date: 2023-06-30
Publication date: 2023-12-14
Also published as: CN115006103A; CN115006103B

Abstract

Provided is an ocular implant catheter, comprising an implant catheter body. The implant catheter body is longitudinally arranged, with a front end of the implant catheter body being an advancing end (21) and a rear end of the implant catheter body being a force-receiving end (22). The implant catheter body comprises a hollow interior, which forms a fluid channel (23). The wall of the implant catheter body comprises connecting bodies (30) and hollowed-out cavities (24) located between the connecting bodies (30). The hollowed-out cavity (24) is communicated with the fluid channel (23). The projection area of the hollowed-out cavities (24) on the wall is smaller than the projection area of the connecting bodies (30) on the wall. The implant catheter body is arc-shaped, with an outer diameter of 0.25-0.4 mm. The thickness of the wall is 0.01-0.2 mm. As such, the supporting effect and the flow-guiding effect of the implant catheter body can be effectively coordinated.

Description

eye implant

This invention claims priority to the Chinese patent application filed with the Chinese Patent Office on June 10, 2022, with application number 2022106581313 and the application name "Ocular Implant", the entire content of which is incorporated into the present invention by reference.

Technical field

The invention belongs to the field of medical devices, and specifically relates to eye implants.

Background technique

The eye includes an anterior chamber between the cornea, iris, and 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 (usually about 2.2 to 2.7 microliters per minute) and flows between the lens and iris in a conventional outflow pathway. passes through, and is then expelled via the trabecular meshwork and returned to the circulatory system.

The intraocular pressure that maintains this outflow from a normal eye tends to remain in the range of 10mmHg to 20mmHg. However, there may be significant variation in IOP related to the cardiac cycle, blinking, daytime activity, and other causes. If there is an obstruction in the trabecular meshwork fluid outflow path, this will result in excessive fluid accumulation in the eye and subsequently increase the IOP to a value that is always greater than approximately 18 mmHg. In some cases, the IOP may be as high as 50mmHg or greater. Over time, this increased pressure causes irreversible damage to the optic nerve and leads to vision loss.

Commonly used treatments include medication, laser trabeculoplasty, trabeculectomy, and intraocular drainage implants.

Intraocular drainage implants are most commonly used when other treatments have failed. These implants include a drainage device that is inserted into the eye during surgery to allow the aqueous humor to drain. Can be drained through a drainage path and out of the anterior chamber.

However, existing eye implants cannot effectively coordinate the support effect and diversion effect during implantation.

Contents of the invention

The object of the present invention is to provide an eye implant, which can effectively improve the coordination of the support effect and the diversion effect of the implant body.

The technical solution is as follows:

Ocular implants, including implant bodies,

The implant tube body is arranged longitudinally, with its front end forming a forward end and its rear end forming a force application end;

The interior of the implant body is hollow to form a fluid channel;

The wall of the implanted tube body includes a connecting body and a hollow cavity located between the connecting bodies, and the hollow cavity is communicated with the fluid channel;

The projected area of the hollow cavity on the tube wall is smaller than the projected area of the connecting body on the tube wall;

The implant tube body is curved in an arc shape, its outer diameter is 0.25 mm to 0.4 mm, and the tube wall thickness is 0.01 mm to 0.2 mm.

In one embodiment, in a natural state, the implant body is distributed from one-sixth to one-third of the overall arc relative to its center of curvature.

In one embodiment, the connecting body includes a first main base body and a second main base body located in the first direction, and a third main base body and a fourth main base body located in the second direction;

The first main base body, the second main base body, the third main base body, and the fourth main base body all extend toward the first end of the implant tube body to form two first connecting arms. The first main base body , the second main base body, the third main base body, and the fourth main base body all extend toward the second end of the implant body to form two second connecting arms;

The first connecting arm of the first main body and the second main body and the third main body and the fourth The second connecting arms of the main base body are connected; the second connecting arms of the first main base body and the second main base body are connected with the first connecting arms of the third main base body and the fourth main base body. connect.

In one embodiment, the two first connecting arms of the first main base are respectively connected to the second connecting arms on the same side of the third main base and the fourth main base;

The two second connecting arms of the first main base are respectively connected to the first connecting arms on the same side of the third main base and the fourth main base.

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 at the first connection arm of the first main base body, the second main base body and the second connection arm of the third main base body, the fourth main base body. between arms.

In one embodiment, the first main base body, the third main base body, the second main base body, and the fourth main base body are arranged in sequence along the circumferential direction of the implant body.

In one embodiment, the connecting body has a plurality of main base bodies, and the plurality of main base bodies are evenly staggered along different circumferential positions and different axial positions of the implant body, and between adjacent main base bodies Connected by connecting arms; wherein at least part of the connecting arms has bending buffer sections, and there is a gap between two bending buffer sections in different circumferential directions.

In one embodiment, the implant body has at least a first datum plane and a second datum plane. The first datum plane is offset relative to the second datum plane. The implant body is on the first datum plane. The bending flexibility is close to the bending flexibility of the implant body at the second reference plane.

In one embodiment, the bending flexibility of the implant body on the first datum plane is equal to the bending flexibility of the implant body on the second datum plane.

In one embodiment, the first datum plane is perpendicular to the second datum plane.

In one embodiment, the first reference plane is located on a plane where the arc-shaped implant body is located.

In one embodiment, in the cross-section of the implant body, the hollow cavity and the connecting body located on the first side of the first datum plane are different from those located on the second side of the first datum plane. The hollow cavity and the connecting body correspond to each other, and the hollow cavity and the connecting body located on the first side of the second datum plane and the hollow cavity located on the second side of the second datum plane The cavity corresponds to the connecting body.

In one embodiment, partial areas of the hollow cavity located on the first reference plane are evenly spaced from each other, and partial areas of the hollow cavity located on the second reference plane are evenly spaced from each other.

A guide slope is formed at the front end of the advancing end, and a force applying notch is provided on the force applying end.

The technical solution provided by the present invention has the following advantages and effects:

The eye implant has a tube structure as a whole, and the outer diameter of the implant body is 0.25 mm to 0.4 mm. The implant body is curved as a whole, and the implant body can be connected with the eye. It is consistent with the physiological characteristics of the implanted tube body. The interior of the implanted tube body is hollow to form a fluid channel. The wall of the implanted tube body includes a connector and a hollow cavity. After the eye implant is implanted into the human eye, it can effectively remove the aqueous humor. It enters the fluid channel through the hollow cavity and is discharged from the anterior chamber through the fluid channel of the implanted tube body, thereby achieving a balance of hydraulic pressure inside and outside the anterior chamber; the projected area of the hollow cavity on the tube wall is smaller than that of the connecting body on the tube wall. The projected area of the tube wall can effectively ensure the support strength of the implanted tube body on the premise of achieving aqueous humor drainage; the front end of the implanted tube body forms a forward end, and its rear end forms a force application end. During the implantation operation, By applying force to the force-applying end, the advancing end is pushed toward the anterior end, and the implant tube body is implanted into the anterior segment.

Description of the drawings

Figure 1 is a structural diagram of an eye implant in a first direction according to an embodiment of the present invention;

Figure 2 is an enlarged view of point A in Figure 1;

Figure 3 is a partial enlarged view of Figure 2;

Figure 4 is a structural diagram of the eye implant in the second direction according to the embodiment of the present invention;

Figure 5 is an enlarged view of B in Figure 4;

Figure 6 is a partial enlarged view of Figure 5;

Figure 7 is a structural diagram of the third direction of the eye implant according to the embodiment of the present invention;

Figure 8 is an enlarged view of C in Figure 7;

Figure 9 is a partial enlarged view of Figure 8;

Explanation of reference symbols:

11. The first datum plane, 12. The second datum plane,

21. Advance end, 211. Guide slope, 22. Force application end, 221. Force application gap, 23. Fluid channel, 24. Hollow cavity,

30. Connector, 311. First main base body, 312. Second main base body, 313. Third main base body, 314. Fourth main base body, 321. First connecting arm, 322. Second connecting arm, 323. One bending buffer section, 324, second bending buffer section, 325, inner arc edge, 3261, first inner straight edge, 3262, second inner straight edge, 330, deformation gap.

Detailed ways

In order to facilitate understanding of the present invention, specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings.

Unless otherwise specified or otherwise defined, the "first, second..." used in this article are only used to distinguish names and do not represent a specific number or order.

Unless specifically stated otherwise or otherwise defined, the term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

It should be noted that "fixed to" and "connected to" in this article may be directly fixed or connected to an element, or may be indirectly fixed or connected to an element.

As shown in Figures 1 to 9, an eye implant includes an implant body, which is arranged longitudinally, with its front end forming a forward end 21, and its rear end forming a force application end 22; the implant The interior of the tube body is hollow to form a fluid channel 23; the wall of the implanted tube body includes a connecting body 30 and a hollow cavity 24 located between the connecting bodies 30, and the hollow cavity 24 communicates with the fluid channel 23; so The projected area of the hollow cavity 24 on the tube wall is smaller than the projected area of the connector 30 on the tube wall; the implant tube body is curved in an arc, and its outer diameter is 0.25 mm to 0.4 mm. Thickness is 0.01 mm to 0.2 mm.

The eye implant has a tube structure as a whole, and the outer diameter of the implant body is 0.25 mm to 0.4 mm. The implant body is curved as a whole, and the implant body can match the physiological characteristics of the eye. Consistent with each other, the interior of the implant body is hollow to form a fluid channel 23. The wall of the implant body includes a connector 30 and a hollow cavity 24. After the eye implant is implanted into the human eye, the aqueous humor can be effectively transferred. It enters the fluid channel 23 through the hollow cavity and is discharged from the anterior chamber through the fluid channel 23 of the implanted tube body, thereby achieving a balance of hydraulic pressure inside and outside the anterior chamber; the projected area of the hollow cavity 24 on the tube wall is smaller than that of the connecting body 30 The projected area of the tube wall can effectively ensure the support strength of the implanted tube body on the premise of achieving aqueous humor drainage; a forward end 21 is formed at the front end of the implanted tube body, and a force applying end 22 is formed at its rear end. During the implantation operation, force is applied to the force-applying end 22 to push the advancing end 21 forward in the anterior direction, and the implant tube body is implanted into the anterior segment.

As shown in FIGS. 1 and 4 , in this embodiment, in a natural state, the implant body is distributed in about a quarter of the entire arc relative to its center of curvature. After the eye implant is implanted into the human eye, it can guide part of the anterior chamber of the human eye. If the area that needs to be guided is larger, the length of the eye implant can be increased accordingly, or Multiple such ocular implants may be used.

In order to facilitate the accurate implantation of the eye implant in the human eye in this embodiment, in this embodiment, try to ensure that the bending flexibility of the implant body in several directions does not differ too much. Specifically, , the implant body has a first datum plane 11 and a second datum plane 12. In this embodiment, the first datum plane 11 is located on the plane where the arc-shaped implant body is located, and the The second datum plane 12 is the longitudinal section of the implant body. The first datum plane 11 is perpendicular to the second datum plane 12. The bending flexibility of the implant body on the first datum plane 11 is consistent with the bending flexibility of the implant body on the first datum plane 11. The bending flexibility of the implant body on the second datum plane 12 is close to that of the first datum plane 11 . Preferably, the bending flexibility of the implant body on the first datum plane 11 is close to that of the implant body. The bending flexibility of the implant body on the second reference plane 12 is equal. The flexibility of the implant body can be achieved by using the structure of this embodiment. It can be understood that different structures can also be used and different rigidities can be used. material to achieve. The first datum plane 11 is as shown in Figure 4. In this figure, the first datum plane 11 is curved in an arc and is perpendicular to the paper surface shown in Figure 4. The first datum plane 11 is as shown in Figure 7. In this figure , the first reference plane 11 is flat 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 diversion effect of the implant body, and the support effect of the implant body, the implant body in this embodiment The detailed structure can be mainly shown in Figure 3, Figure 6 and Figure 9.

The connecting body 30 includes a first main base 311 and a second main base 312 located in the first direction, and a third main base 313 and a fourth main base 314 located in the second direction; the first main base 311 and the fourth main base 314 are located in the second direction. The three main base bodies 313, the second main base body 312, and the fourth main base body 314 are sequentially arranged along the circumferential direction of the implant body. In this embodiment, the first direction is substantially parallel to the direction of the second reference plane 12 , and the second direction is substantially parallel to the first reference plane 11 .

The connecting body 30 has a plurality of main base bodies, which are evenly staggered along different circumferential positions and different axial positions of the implant body, and adjacent main base bodies are connected by connecting arms; wherein , at least part of the connecting arm has a bending buffer section, and there is a gap between two bending buffer sections in different circumferential directions. The following is a detailed structural description of the connecting body 30:

The first main base 311, the second main base 312, the third main base 313, and the fourth main base 314 all extend toward the first end of the implant body to form two first connecting arms 321, so The first main base 311, the second main base 312, the third main base 313, and the fourth main base 314 all extend toward the second end of the implant body to form two second connecting arms 322;

The first connecting arms 321 of the first main base 311 and the second main base 312 are connected to the second connecting arms 322 of the third main base 313 and the fourth main base 314; the first The second connecting arms 322 of the main base 311 and the second main base 312 are connected to the first connecting arms 321 of the third main base 313 and the fourth main base 314; specifically:

The two first connecting arms 321 of the first main base 311 are respectively connected to the second connecting arms 322 on the same side of the third main base 313 and the fourth main base 314; matrix The two second connecting arms 322 of 311 are respectively connected to the first connecting arms 321 on the same side of the third main base 313 and the fourth main base 314. The two first connecting arms 321 of the second main base 312 are respectively connected to the second connecting arms 322 on the same side of the third main base 313 and the fourth main base 314; The two second connecting arms 322 of the base 312 are respectively connected to the first connecting arms 321 on the same side of the third main base 313 and the fourth main base 314 .

The two first connecting arms 321 of the first main base 311 and the second main base 312 each have a first bending buffer section 323. The two first bending buffer sections 323 of the third main base 313 and the fourth main base 314 Each of the second connecting arms 322 has a second bending buffer section 324; the adjacent first main base 311, second main base 312, third main base 313, and fourth main base 314 are bent Among the buffer sections, the first first bending buffer section 323 of the first main base 311 is connected with the first second bending buffer section 324 of the fourth main base 314. The first main base 311 The second first bending buffer section 323 is connected with the first second bending buffer section 324 of the third main base 313, and the first first bending buffer section 323 of the second main base 312 The second first bending buffer section 323 of the second main base 312 is connected with the second second bending buffer section 324 of the third main base 313 . The first bending buffer section 323 and the second bending buffer section 324 are butt-jointed; in the first bending buffer section 323 and the second bending buffer section 324, the bending directions are opposite. A first inner straight edge 3261 and a second inner straight edge 3262 are formed on the back side of 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 aforementioned connection structure of the first main base 311, the second main base 312, the third main base 313, and the fourth main base 314 can make the entire implant tube body have a mesh structure, which can first meet the requirements of aqueous humor diversion. Secondly, it can meet the overall support requirements of the implant body, and thirdly, it can meet the bending flexibility requirements of the implant body when deformed in all directions.

The arrangement of the first bending buffer section 323 and the second bending buffer section 324 allows the implantation tube body to be deformed more conveniently when bending. During the deformation process, if the implantation tube body When bending or deformation occurs, due to the existence of the deformation gap 330, it is possible to ensure that the overall implant body has a certain space for deformation. On the other hand, during or after implantation, if the deformation of the implant body exceeds a certain range , then the first inner straight edge 3261 and the second inner straight edge 3262 can limit further bending deformation.

As shown in Figure 3, Figure 6 and Figure 9, the first main base 311, the second main base 312, the third main base There are inner arc edges 325 between the two first connecting arms 321 and between the two second connecting arms 322 on the base body 313 and the fourth main base body 314. When the implanted tube body is bent and deformed, the tube wall can be avoided. produce greater distortion.

In this embodiment, in the cross-section of the implant body, the hollow cavity 24 and the connecting body 30 located on the first side of the first reference plane 11 are different from those located on the first reference plane 11 The hollow cavity 24 and the connecting body 30 on the second side correspond to each other, and the hollow cavity 24 and the connecting body 30 on the first side of the second datum plane 12 are opposite to those on the second datum surface 12 . The hollow cavity 24 on the second side of the surface 12 corresponds to the connecting body 30 . The partial areas of the hollow cavities 24 located on the first reference plane 11 are evenly spaced from each other, and the partial areas of the hollow cavities 24 located on the second reference plane 12 are evenly spaced from each other. This structure can effectively ensure that the flexibility of the implant body is basically consistent in all directions, and avoids implantation difficulties caused by local bending flexibility of the implant body, or uneven local support rigidity. The diversion is not smooth. It can be understood that since the main body of the implant body is in a curved state and considering the processing error of the product, the aforementioned "correspondence" and "even spacing" do not require specific and strict dimensional requirements, and certain errors or offset.

A guide slope 211 is formed at the front end of the advancing end 21 , and a force applying notch 221 is provided on the force applying end 22 . During implantation, the front end of the implant tool can be inserted into the force-applying notch 221, and the guide bevel 211 at the front end can guide the implantation of the implant tube body.

In this embodiment, the first main base 311, the second main base 312, the third main base 313, the fourth main base 314 of the implant body and their first connecting arms 321 and second connecting arms 322 The whole body is formed in one piece, and its material can be surgical implant metal, polymer material or biological material. The metal includes but is not limited to titanium alloy, magnesium alloy, nickel titanium alloy, tantalum alloy, preferably nickel titanium alloy; the polymer material includes silicone or Polylactic acid PLGA; biological materials include animal-derived tissues, human-derived tissues, purified collagen or recombinant collagen.

It can be understood that in this embodiment, the outer diameter of the implanted tube body is 0.25 mm to 0.4 mm, and the tube wall thickness is 0.01 mm to 0.2 mm. When the corresponding outer diameter dimensions and tube wall thickness dimensions are adopted, It is necessary to meet the necessary optimization and coordination of its size. For example, when the pipe wall thickness is 0.15 mm, its outer diameter cannot be 0.25 mm. Considering the necessary size of its fluid channel, its outer diameter should be at least 0.3 mm or more.

The above embodiments are not an exhaustive list of the present invention. In addition, there may be many other unlisted implementations. Any substitutions and improvements made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

An eye implant is characterized in that it includes an implant body,

The implant tube body is arranged longitudinally, with its front end forming a forward end and its rear end forming a force application end;

The interior of the implant body is hollow to form a fluid channel;

The wall of the implanted tube body includes a connecting body and a hollow cavity located between the connecting bodies, and the hollow cavity is communicated with the fluid channel;

The projected area of the hollow cavity on the tube wall is smaller than the projected area of the connecting body on the tube wall;

The implant tube body is curved in an arc shape, its outer diameter is 0.25 mm to 0.4 mm, and the tube wall thickness is 0.01 mm to 0.2 mm.
The eye implant according to claim 1, characterized in that, in a natural state, the implant body is distributed in one-sixth to one-third of the overall arc relative to its center of curvature.
The eye implant according to claim 1, wherein the connecting body includes a first main body and a second main body located in the first direction, and a third main body and a fourth main body located in the second direction. matrix;

The first main base body, the second main base body, the third main base body, and the fourth main base body all extend toward the first end of the implant tube body to form two first connecting arms. The first main base body , the second main base body, the third main base body, and the fourth main base body all extend toward the second end of the implant body to form two second connecting arms;

The first connecting arms of the first main base body and the second main base body are connected to the second connecting arms of the third main base body and the fourth main base body; the first main base body and the second main base body The second connecting arm of the base body is connected to the first connecting arms of the third main base body and the fourth main base body.
The eye implant according to claim 3, characterized in that:

The two first connecting arms of the first main base are respectively connected to the second connecting arms on the same side of the third main base and the fourth main base;

The two second connecting arms of the first main base are respectively connected to the first connecting arms on the same side of the third main base and the fourth main base.
The ocular implant according to claim 4, wherein at least one of the first connecting arm and the second connecting arm is provided with a bending buffer section.
The eye implant according to claim 5, characterized in that:

The bending buffer section is located between the first connecting arms of the first main base body and the second main base body and the second connecting arms of the third main base body and the fourth main base body.
The eye implant according to claim 3, wherein the first main base, the third main base, the second main base, and the fourth main base are arranged in sequence along the circumferential direction of the implant body. .
The eye implant according to claim 3, wherein the connecting body has a plurality of main base bodies, and the plurality of main base bodies are evenly staggered along different circumferential positions and different axial positions of the implant body. , adjacent main base bodies are connected through connecting arms; wherein at least part of the connecting arms have bending buffer sections, and there is a gap between two bending buffer sections in different circumferential directions.
The ocular implant according to any one of claims 1 to 8, wherein the implant body has at least a first datum plane and a second datum plane, and the first datum plane deviates from the second datum plane. , the bending flexibility of the implant body on the first datum plane is close to the bending flexibility of the implant body on the second datum plane.
The eye implant according to claim 9, wherein the bending flexibility of the implant body on the first datum plane is equal to the bending flexibility of the implant body on the second datum plane. equal.
The ocular implant of claim 10, wherein the first reference plane is perpendicular to the second reference plane.
The ocular implant according to claim 10, wherein the first reference plane is located on a plane where the arc-shaped implant body is located.
The eye implant according to claim 9, wherein in the cross-section of the implant body, the hollow cavity and the connecting body located on the first side of the first reference plane are in contact with each other. The first The hollow cavity and the connecting body on the second side of the datum plane correspond to each other, and the hollow cavity and the connecting body on the first side of the second datum plane correspond to those on the second side of the second datum plane. The hollow cavity on the side corresponds to the connecting body.
The eye implant according to claim 9, wherein the partial areas of the hollow cavities located on the first reference plane are evenly spaced from each other, and the hollow cavities located on the second reference plane are evenly spaced from each other. Some areas are evenly spaced from each other.