Corneal graft implanter for corneal transplantation
By designing a corneal implant implanter for corneal transplant surgery, the sterile preloading and simplified operation of donor corneal implants is achieved, and the problems of loss and complex operation of donor corneal tissue in the prior art are solved, and are suitable for a variety of corneal transplantation procedures.
Patent Information
- Application Number
- CN202422351809.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-26
- Publication Date
- 2025-08-26
- Estimated Expiration
- 2034-09-26
AI Technical Summary
There is a lack of implants that can implant donor corneal tissue of different thicknesses in various surgical procedures in existing corneal transplant surgery, and donor corneal tissue is easily lost during the implantation process, making it difficult to widely use complex and expensive tools.
A corneal implant implanter for corneal transplant surgery is designed to preload donor corneal implants under sterile conditions and implant through small incisions to avoid direct contact with the donor corneal. The implanter elements and bottles made of transparent visual materials are simplified.
It realizes sterile storage and transportation of donor corneal transplantation sheets, reduces the loss of donor corneal endothelial cells, simplifies surgical operations, is suitable for a variety of corneal transplantation methods, and reduces the complexity and cost of surgery.
Smart Images
Figure CN223263091U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of corneal transplant surgery instruments, in particular to a corneal graft implanter for corneal transplant surgery. Background Art
[0002] The corneal endothelium, a single layer of cells, forms a barrier between the corneal stroma and the anterior chamber. It pumps excess water from the stroma to maintain corneal transparency and absorbs nutrients from the aqueous humor to supply the cornea. Human corneal endothelial cells cannot regenerate and decrease over the years. When endothelial dysfunction occurs, such as in bullous keratopathy, Fuchs' endothelial dystrophy, corneal edema after cataract surgery, and iridocorneal endothelial syndrome, resulting in loss of corneal transparency and vision, donor corneal endothelial transplantation is required.
[0003] Conventional penetrating keratoplasty (PK) replaces the entire layer of the diseased cornea (including the endothelium) with a healthy donor cornea. After the operation, there are incisions and sutures on the patient's corneal surface, which is prone to complications such as poor corneal healing, infection, loss of donor corneal endothelial cells, secondary glaucoma, and immune rejection, leading to transplant failure.
[0004] Currently, the preferred transplantation surgery for corneal endothelial dysfunction is endothelial keratoplasty (EK), which refers to preserving the healthy corneal epithelium, anterior Descemet's membrane and stroma, and replacing only the posterior Descemet's membrane and endothelium of the diseased cornea. Transplantation procedures include deep lamellar endothelial keratoplasty (DLEK), Descemet's membrane tearing endothelial keratoplasty (DSEK), Descemet's membrane tearing automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK).
[0005] EK completes intraocular surgery by entering through a small incision at the corneal limbus. This minimally invasive technique maintains the integrity of the eye, causes minimal damage, is relatively safe, has a low probability of corneal perforation during surgery, and reduces the incidence of postoperative astigmatism.
[0006] The surgical implantation of donor corneal tissue through a small limbal incision often requires an auxiliary tool. Among the currently known medical tools for corneal tissue delivery, one can be used in DLEK, DSEK, and DSAEK procedures. During use, the deployment and retraction rollers on the tool's surface control the extension and retraction of a distal cannula and its flexible support member. When extended, the donor corneal tissue is placed on the surface of the flexible support, and the two rollers are adjusted to control the retraction of the flexible support with the donor corneal tissue into the cannula, thereby controlling the retraction of the cannula into the internal cavity of the device. During the transplantation operation, the cannula is extended by adjusting the two rollers, and the distal end of the cannula is implanted into the anterior chamber through the corneal limbus incision. The rollers are adjusted again to extend the flexible support and the donor corneal graft on its surface and deploy them to the appropriate position. The fluid channel cap at the proximal end of the device is removed, and a pressurized fluid flow source (such as a syringe, a syringe, a hanging fluid bag, an infusion pump, or other flow source) is connected to the fluid channel inside the device, thereby injecting the donor corneal tissue at the distal end of the device into the anterior chamber. However, due to the complex mechanical control during the operation, the surgeon needs to be proficient in the operation of the tool. At the same time, it is expensive and is an imported product, so it is rarely used in domestic clinical practice.
[0007] Another type of syringe suitable for DMEK surgery is the Straiko syringe, which primarily consists of a modified glass Jones tube, resembling a medicine dropper with a tapered distal end and a larger center. Before surgery, the surgeon connects the modified Jones tube to a 3 mL syringe via a single-lumen suction cannula, ensuring a complete seal and expelling all air from the syringe. The surgeon then places the tip of the tube, beveled upward, beneath one end of the curled donor corneal tissue (the stripped donor Descemet's membrane and endothelial tissue naturally curl into a cylindrical shape). The surgeon gently draws the plunger slowly and intermittently, drawing the graft into the tube until the donor corneal tissue is located midway along the tube's distal bulge. The surgeon then places the tip of the tube, beveled downward, against the wall of the small limbal incision. Once the position is correct, the syringe is pushed forward, injecting the donor corneal tissue into the anterior chamber along with the liquid in the tube. However, the tip of the modified glass Jones tube is very narrow and is only suitable for loading donor corneal tissue with a thickness not exceeding 13-15 μm. The thickness of donor tissue required for DLEK, DSEK, and DSAEK surgeries is usually 90-120 μm, so the modified glass Jones tube is difficult to apply to other transplantation procedures.
[0008] With new breakthroughs in surgical procedures and the emergence of a variety of products that can serve as donor corneal tissue substitutes (such as artificial corneas, acellular corneal stroma, tissue-engineered corneal endothelium and posterior lamellae, etc.), there is currently a lack of an implanter that can implant donor corneal tissue grafts of varying thicknesses for various procedures. Furthermore, if the donor corneal tissue grafts could be pre-loaded into the implanter, stored and transported to the surgical site in a sterile manner, the surgeon would have easier access and more time to devote to preparing the implant bed in the recipient eye and performing the implantation procedure. A simpler implanter would be more conducive to the widespread development and application of new transplantation technologies. Therefore, a corneal graft implanter for corneal transplant surgery is provided. Utility Model Content
[0009] In order to solve the above problems, the present invention provides a corneal graft implanter for corneal transplant surgery, which pre-loads donor corneal grafts (such as processed donor eye tissue, produced artificial cornea, decellularized corneal stroma, tissue-engineered corneal endothelium and posterior plate products) at a location far away from the patient's surgery (such as an eye bank, a GMP workshop of a biological company); stores and transports them to the patient's surgery location in a sterile manner, and the surgeon can directly access them. The donor corneal graft remains untouched by the physician during the receiving and implanting process, thereby minimizing the loss of donor corneal endothelial cells; and at the same time, small incision corneal transplant surgery is performed through the implanter, providing convenient transplantation for ophthalmologists.
[0010] The technical solution of the utility model is as follows:
[0011] A corneal graft implanter for corneal transplant surgery includes an implanter element, a connecting hose, a bottle cap, a bottle body and a syringe. The bottle cap includes a cover body that is detachably fixedly connected to the bottle mouth of the bottle body and a push-pull plunger device. The push-pull plunger device includes a plunger rod, a plunger and a plunger cylinder. One end of the plunger rod is fixedly connected to the cover body, and the other end of the plunger rod airtightly passes through the top of the plunger cylinder and is fixedly connected to the plunger in the plunger cylinder. The plunger and the plunger cylinder are airtightly slidably matched, and a connecting pipe is provided at the bottom of the plunger cylinder. The implanter element is a tubular structure, and the bottom of the implanter element is provided with a tip structure formed by an inclined surface, and the upper part is provided with a protruding structure. The connecting hose is used to connect the top of the implanter element with the connecting pipe or the injection port of the syringe.
[0012] The inserter components and bottle body are made of transparent viewing material.
[0013] Optionally, the implanter element and the bottle body are made of transparent glass.
[0014] Optionally, the injector element and the bottle are made of clear plastic.
[0015] The syringe is a 1 mL or 3 mL sterile syringe.
[0016] A sealing gasket is installed between the cover body and the bottle body.
[0017] A sealing film is provided at the connection between the cover body and the bottle body.
[0018] The connecting hose is made of medical silicone.
[0019] The cover body is threadedly connected to the bottle mouth of the bottle body.
[0020] The upper portion of the implanter component is provided with a protrusion.
[0021] The beneficial effects of the present invention are:
[0022] The utility model discloses a corneal graft implanter for corneal transplant surgery. The corneal graft implanter pre-loads donor corneal grafts (such as processed donor eye tissue, produced artificial cornea, decellularized corneal stroma, tissue-engineered corneal endothelium and posterior lamella products) at a location far away from the patient's surgery (such as an eye bank or a GMP workshop of a biological company); stores and transports them to the patient's surgery location in a sterile manner, and the surgeon can directly access them. The donor corneal graft remains untouched by the surgeon during the receiving and implanting process, thereby minimizing the loss of donor corneal endothelial cells; and at the same time, small-incision corneal transplant surgery is performed through the implanter, providing convenient transplantation for ophthalmologists. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] By reading the detailed description of the preferred embodiment below, the solutions and advantages of the present application will become clear to those skilled in the art. The accompanying drawings are only used to illustrate the preferred embodiment and are not to be considered as limiting the present invention.
[0024] In the attached figure:
[0025] Figure 1 This is a schematic structural diagram of a corneal graft implanter for corneal transplant surgery (when the implanter element cooperates with the bottle cap and bottle body) according to an embodiment of the utility model;
[0026] Figure 2 This is a schematic structural diagram of a corneal graft implanter for corneal transplant surgery (when the implanter element is combined with a syringe) according to an embodiment of the present utility model;
[0027] The components represented by the reference numerals in the figure are:
[0028] The utility model comprises: 1. an implanter component, 1a. a protrusion, 2. a connecting hose, 3. a bottle cap, 3a. a cover body, 3b. a plunger rod, 3c. a plunger, 3d. a plunger cylinder, 3d1. a connecting pipe, 4. a bottle body, 5. a syringe. DETAILED DESCRIPTION Example
[0029] like Figure 1 and Figure 2 As shown, the corneal graft implanter for corneal transplant surgery includes an implanter element 1, a connecting hose 2, a bottle cap 3, a bottle body 4 and a syringe 5. The bottle cap 3 includes a cover body 3a detachably fixedly connected to the bottle mouth of the bottle body 4 and a push-pull plunger device. The push-pull plunger device includes a plunger rod 3b, a plunger 3c and a plunger cylinder 3d. One end of the plunger rod 3b is fixedly connected to the cover body 3a, and the other end of the plunger rod 3b is airtightly passed through the top of the plunger cylinder 3d and fixed to the plunger 3c in the plunger cylinder 3d. The plunger 3c and the plunger cylinder 3d are connected in an airtight sliding fit, and a connecting pipe 3d1 is provided at the bottom of the plunger cylinder 3d; the implanter element 1 is a tubular structure, and the bottom of the implanter element 1 is provided with a tip structure formed by an inclined surface, and the upper part is provided with a protruding structure; the connecting hose 2 is used to connect the top of the implanter element 1 with the connecting pipe 3d1 or the injection port of the syringe 5; the airtightness in this embodiment refers to the ability of the two components to prevent the flow of gas or air at the fitting point, which is generally achieved by installing a sealing ring or the like.
[0030] The implanter component 1 and the bottle body 4 are made of transparent visible material; the implanter component 1 and the bottle body 4 are made of transparent glass; optionally, the implanter component 1 and the bottle body 4 are made of transparent plastic.
[0031] Syringe 5 is a 1 mL or 3 mL sterile syringe.
[0032] A sealing gasket is installed between the cover 3 a and the bottle body 4 ; a sealing film is provided at the connection between the cover 3 a and the bottle body 4 .
[0033] The connecting hose 2 is made of medical silicone.
[0034] The cover 3a is threadedly connected to the bottle mouth of the bottle body 4; optionally, the cover 3a is frictionally connected to the bottle mouth of the bottle body 4.
[0035] The upper portion of the implanter member 1 is provided with a protrusion 1 a. Example
[0036] A corneal graft implanter for corneal transplant surgery includes an implanter component, a connecting hose, a cap with a push-pull plunger mechanism, a transport container, and a syringe. Each component has a smooth interior. The implanter component and the transport container can be made of transparent, visible materials such as glass and plastic, making it easier to determine whether the donor corneal tissue graft is properly loaded and to monitor its movement during implantation.
[0037] Under a sterile environment, connect the proximal end of the implanter component to the hose so that the protrusion on the implanter component fits into the distal end of the hose; connect the proximal end of the hose to the distal tip of the plunger device; push the plunger toward the distal end to keep the cavity of the plunger device free of air; aspirate liquid until the connecting hose and the implanter component are filled (the liquid includes but is not limited to corneal organ preservation solution, corneal endothelial cell culture solution, BSS, etc.) and remove all bubbles;
[0038] The donor corneal graft (including processed donor eye tissue, produced artificial cornea, decellularized corneal matrix, tissue-engineered corneal endothelium and posterior lamella products) is placed in a culture container containing liquid and kept in a suspended state.
[0039] The distal end of the implanter is immersed in the liquid, keeping the tip of the bevel below one end of the donor corneal tissue graft. Brief, intermittent pulls on the plunger gently draw the donor corneal tissue graft into the implanter body until it is completely inserted. The donor corneal tissue graft is stored in a roll within the implanter body, with the endothelial surface inside and the stromal surface outside. The push-pull plunger mechanism in the bottle cap creates negative pressure, stabilizing the donor corneal graft during movement and preventing it from slipping out of the implanter body.
[0040] Fill the transport container with liquid (including but not limited to corneal organ preservation solution, corneal endothelial cell culture solution, BSS, etc.), and gently assemble it with the device cap loaded with the donor corneal graft (the assembly method can be friction fit, thread assembly, or other known assembly methods); and completely seal the connection with a sealing film.
[0041] The complete implanter, pre-loaded with the donor corneal graft, and a sterile syringe, which can be a 1 mL or 3 mL sterile syringe, are placed in a sterile shipping container / unit. Identifying information, such as the tissue and the date and time it was loaded, can be recorded on a label attached to the implanter. The implanter is then stored and / or shipped to the surgeon.
[0042] The surgeon first verifies the tissue storage date; under aseptic technique, removes the implant assembly (including the implant assembly containing the donor corneal graft and the connecting hose) and a sterile syringe from the shipping packaging / components; fills the syringe with balanced saline solution (BSS) and attaches it to the implant assembly; the surgeon prepares the patient according to standard endothelial corneal transplantation procedures and makes a lateral incision at the limbus of the patient's face. The length of the lateral incision can be, for example, approximately 3 mm to 4 mm. In some embodiments, the incision can be approximately 3.5 mm long.
[0043] When the implanter assembly is coupled to the syringe, the surgeon can hold the syringe with the implanter tip bevel downward, and use corneal forceps to gently insert it into the side incision of the corneal margin until the tip bevel is against the incision wall; then rotate the implanter body to the tip bevel upward, and after visually confirming that the anterior chamber depth is normal or slightly shallow, slowly push the syringe, accompanied by several short continuous pulses of BSS, to gently push or move the rolled implant out of the implanter element and into the anterior chamber of the eye; the BSS fluid in the syringe helps to open or unfold the implant; observe the anterior chamber depth and ensure that the "S" mark on the implant is in the positive position; ensure that the anterior chamber is drained of liquid through another puncture site, and when the pressure is reduced to an almost collapsed state, withdraw the implanter to avoid the high-pressure part or all of the implant in the anterior chamber being ejected, resulting in failure of the transplant operation.
Claims
1. A corneal graft implanter for corneal transplantation surgery, characterized in that: The invention comprises an implanter element (1), a connecting hose (2), a bottle cap (3), a bottle body (4) and a syringe (5), wherein the bottle cap (3) comprises a cover body (3a) detachably fixedly connected to the bottle mouth of the bottle body (4) and a push-pull plunger device, wherein the push-pull plunger device comprises a plunger rod (3b), a plunger (3c) and a plunger cylinder (3d), wherein one end of the plunger rod (3b) is fixedly connected to the cover body (3a), and the other end of the plunger rod (3b) is airtightly passed through the plunger cylinder (3d). The top is fixedly connected to the plunger (3c) in the plunger cylinder (3d), the plunger (3c) and the plunger cylinder (3d) are airtightly slidably matched, and a connecting pipe (3d1) is provided at the bottom of the plunger cylinder (3d); the implanter element (1) is a tubular structure, the bottom of the implanter element (1) is provided with a tip structure formed by an inclined surface, and the upper part is provided with a protruding structure; the connecting hose (2) is used to connect the top of the implanter element (1) and the connecting pipe (3d1) or the injection port of the syringe (5).
2. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: The implanter element (1) and the bottle body (4) are made of transparent visible material.
3. The corneal graft implanter for corneal transplantation according to claim 2, characterized in that: The implant element (1) and the bottle body (4) are made of transparent glass.
4. The corneal graft implanter for corneal transplantation according to claim 2, characterized in that: The implanter element (1) and the bottle body (4) are made of transparent plastic.
5. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: The syringe (5) is a 1 mL or 3 mL sterile syringe.
6. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: A sealing gasket is installed between the cover body (3a) and the bottle body (4).
7. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: A sealing film is provided at the connection between the cover body (3a) and the bottle body (4).
8. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: The connecting hose (2) is made of medical silicone material.
9. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: The cover body (3a) is threadedly connected to the bottle mouth of the bottle body (4).
10. The corneal graft implanter for corneal transplantation according to claim 1, characterized in that: The upper portion of the implanter element (1) is provided with a protrusion (1a).