WO2011102725A1

WO2011102725A1 - An ophtalmic surgical device and a method of preparing a device

Info

Publication number: WO2011102725A1
Application number: PCT/NL2011/050120
Authority: WO
Inventors: Gerrit Jan Vijfvinkel; Gerrit Reinold Jacob Melles
Original assignee: Medical Technology Transfer Holding B.V.
Priority date: 2010-02-19
Filing date: 2011-02-21
Publication date: 2011-08-25
Also published as: NL2004269C2

Abstract

The invention relates to an ophthalmic surgical device (1) for inserting a fragile implant, such as a donor Descemet membrane, into a human eye. The device comprises a tube (2) having a distal end (3) for insertion in the eye and a proximal end (4). The tube includes a bend (8) between the distal end and the proximal end. Preferably, the inner wall of the tube has a smooth surface. Preferably, the proximal end is arranged for coupling with a luer lock connector (5).

Description

Title: An ophthalmic surgical device and a method of preparing a device

The invention relates to an ophthalmic surgical device.

The eyeball is basically a rigid sphere filled with fluids. There are three chambers of fluid in the eye: Anterior Chamber (between the cornea and the iris), Posterior Chamber (between iris, zonule fiber and lens) and the Vitreous Chamber (between the lens and the retina). The first two chambers are filled with a clear fluid called aqueous humour whereas the vitreous chamber is filled with a more viscous fluid, the vitreous humour.

In all chambers of the eye, specific tissue structures are present that are eligible for transplantation and/or replacement, in the event of a disorder affecting said tissue structure. These structures are often thin and fragile, so that the insertion of a donor (i.e. a living tissue structure) or synthetic implant is usually challenging. As an example, Descemet membrane, the basement membrane between the corneal stroma and the corneal endothelium (a cellular monolayer facing the anterior chamber of the eye) may be considered.

Descemet membrane is composed of collagen I and IV and ranges in thickness from 3 pm at birth to 8-25 pm in adults. Various corneal endothelial disorders, including bullous keratopathy and Fuchs endothelial dystrophy may require an isolated Descemet membrane transplantation carrying its donor

endothelium, referred to as Descemet membrane (automated) endothelial keratoplasty (DMEK or DMAEK) to replace both the altered recipient

Descemet membrane as well as the recipient endothelial (non-regenerative) cells.

Plastic intraocular lens cartridges are commonly used for insertion of various implants, but these injectors are known to cause damage to (cellular or cell-carrying) tissues or fragile synthetic materials. Also, the insertion is often hindered by the angle of the cartridge relative to the scleral or corneal incision. Cartridges are usually supported by a handle extending from the cartridge, so that the 'angle of attack' is relatively flat, ie parallel to the iris- diaphragma. With all types of cartridges, loading is usually bothersome and requires direct, physical manipulation of the implant. Furthermore, the delivery of the implant often requires a (stiff) viscoelastic substance to overcome the resistance of the inner walls of the cartridge, in order to push the implant out of the cartridge into one of the chambers of the eye.

The aim of the present invention is to provide an ophthalmic surgical device for inserting a fragile implant, e.g. a donor Descemet membrane, into the eye in a "no touch" fashion, i.e. without direct

manipulation and/or physically touching the implant. According to an aspect of the invention, an ophthalmic surgical device is provided for inserting an implant into a human eye. Thereto, the device according to the invention comprises a tube having a distal end for insertion in the eye and a proximal end wherein the tube includes a bend between the distal end and the proximal end.

By providing a tube having a distal end for insertion in the eye and a proximal end, wherein the inner wall of the tube has a smooth surface, the fragile implant can move trough the tube relatively easily. A smooth inner wall, preferably made of glass, induces little damage and/or resistance during delivery of the implant to the eye. As a consequence, donor tissue or synthetic implants, such as a Descemet membrane transplant, can be inserted into one of the chambers of the eye with relative ease thus reducing any chance that damage to the implant occurs. Surprisingly, delivery of a fragile implant can be realized in an easy surgical way without the use or need of a visco-elastic substance.

The inner wall of the tube can have a natural smooth surface, such as a surface of various glass types. However, the smooth surface of the inner wall can also be obtained otherwise, e.g. by performing a polishing action thus providing a smoothened inner wall surface. Preferably, the surface of the inner wall is ultra smooth. In a preferred embodiment according to the invention, the thin distal end of the tube, preferably approximately 0.5 to 5 mm in outer diameter, is arranged for both the insertion of the implant through an ocular (1 to 5 mm tunnel) incision into one of the chambers of the eye, as well as to accommodate a suction device for the process of loading the implant. By providing a wider proximal end of the tube, preferably approximately 2 to 15 mm in outer diameter, the proximal end can be arranged for both loading the implant, as well as for accommodating a removable luerlock attachment to connect the tube to a device to create a flow of biocompatible liquid through the tube. In a preferred embodiment, the implant is 'poured' into a vial with biocompatible liquid. Using the tube with the suction device on the thin distal end, the implant is drawn halfway into the tube. The suction device is disconnected and the luerlock attachment is positioned onto the proximal end. A syringe containing biocompatible liquid can than be positioned into the luerlock attachment. By exerting a pressure, from the proximal end, for example by moving the plunger of the syringe downwardly, the implant can be inserted into one of the eye chambers, via the tube, in a controlled manner, that is by forcing the implant to exit the tube via the distal end. Preferably, the implant is continuously submerged in a biocompatible balanced salt solution, during the entire loading and insertion procedure.

Advantageously, the tube may be manufactured with a bend. By providing a curved injector, a surgically convenient 'angle of attack' can be obtained. During use of the device, the distal end can be oriented mainly horizontal, while the proximal end can be oriented virtually vertical, i.e. in the sagittal plane relatively to the patient, thereby allowing easy handling of the instrument during implantation.

According to an aspect to the invention, tissue or synthetic implants can be manipulated in a completely "no touch" fashion, that is, without direct manipulation or physical contact between any additional surgical instrument and the implant. As such, any change of damage to the implant can be reduced to a minimum throughout the entire loading and insertion procedure.

The invention also relates to a method of performing ophthalmic surgery.

Further advantageous embodiments according to the invention are described in the following claims.

By way of example only, embodiments of the present invention will now be described with reference to the accompanying figures in which

Fig. 1 shows a schematic cross sectional view of an ophthalmic surgical device according to the invention;

Fig. 2 shows a schematic exploded view of the device of Fig. 1;

Fig. 3 shows a first schematic partial cross sectional view of the human eye;

Fig. 4 shows a second schematic particle cross sectional view of the human eye;

Fig. 5 shows a flow chart of steps of a method according to the invention.

It is noted that the figures show merely a preferred embodiment according to the invention. In the figures, the same reference numbers refer to equal or corresponding parts.

Figure 1 shows a schematic cross sectional view of an ophthalmic surgical device 1 according to the invention. Further, Figure 2 shows a schematic exploded view of the device 1. The surgical device 1 is intended for use in a surgical method for injecting a Descemet membrane transplant into the eye, replacing an original, damaged Descemet membrane.

The device 1 comprises a tube 2 having a distal end 3 for insertion in the eye and a proximal end 4 that is arranged for coupling with a luer lock connector 5. The inner wall 6 of the tube 2 is smooth or has been polished to obtain a polished wall surface, and defines a channel 7. Advantageously, the inner wall 6 is formed from a glass material providing a smooth surface, so that a cohesion force between the transplant with the inner wall 6 is minimal, thereby facilitating that the transplant glides easily through the channel 7. In principle, the inner wall 6 can be formed from another material providing a minimal cohesion between the transplant and the channel wall 6, such as ultra smooth synthetic material, e.g. highly polished polymethyl metacrylate

(PMMA).

Preferably, the tube 2 is a glass blown product, thereby providing a device 1 that can be manufactured in a known, cheap, recyclable and relatively easy process. Further, the tube can be cleaned easily for re-use. It will be apparent to the person skilled in the art that the invention is not limited to a glass blown device, also other manufacturing processes can be used, e.g.

injection moulding.

As shown in Figures 1 and 2, the tube 2 has a substantially elongated structure, including a bend 8 to enable easy handling of the device during the surgical process. The bend is located substantially halfway between the distal end and the proximal end. The bend can be located closer to the proximal end than to the distal end. As an example, the angle between the distal end longitudinal axis A and the proximal end longitudinal axis B is circa 120°. In another embodiment according to the invention, the tube 2 is straight without bends. In general, the above mentioned angle is fixed in a range from circa 90° to 180°. Further, the tube can also be provided with multiple bends.

In a practical embodiment according to the invention, the diameter of the channel 7 reaches a minimum value near the distal end 3. As an example, the smallest diameter of the channel 7 in the tube is circa 2 mm. In a zone near the bend 8, the channel diameter is larger, e.g. circa 6 mm. Further, the diameter of the channel in the luer lock connector 5 connected to the tube 2 is even larger, e.g. circa 8 mm. Then, the inner diameter of the tube has a maximum value near the proximal end. It is noted that the numerical values of dimensions and angles of the device in a specific embodiment can deviate from the numbers mentioned above. Figure 3 shows a schematic partial cross sectional view of the human eye 20. The eye contains an anterior chamber 21 and a posterior chamber 22. Further, the cornea 23 is shown, being adjacent to the anterior chamber 21 via the endothelium 24.

Fig. 4 shows a second schematic particle cross sectional view of the human eye 20. Again, the endothelium 24 is shown being adjacent to the anterior chamber 21. The endothelium 24 is covered by the Descemet membrane 25. Further, the cornea 23 includes the stroma 26 covering the Descemet membrane 25, and the epithelium 28, the stroma 26 and the epithelium 28 being separated by the Bowman's membrane 27.

According to an aspect of the invention, treatment of a damaged Descemet membrane is performed through direct surgery, using the

ophthalmic surgical device 1 shown in Fig. 1.

Figure 5 shows a flow chart of method steps according to the invention. The method includes performing ophthalmic surgery. The method comprises an incision step 101 of making an incision in the eye, e.g. the cornea, an insertion step 102 of inserting the distal end 3 of the device 1 into the incision; and an injection step 103 of injecting a fragile transplant, such as a Descemet membrane, through the device tube 2 into the eye. During the insertion step 102, the Descemet membrane transplant flows through the channel 7. Preferably, an aqueous solution is added to the tube 2 to further facilitate the flowing process in the channel 7. As an example, the aqueous solution includes a biocompatible balanced salt solution (BSS).

Before injecting the Descemet membrane through the device tube 2, the transplant can be inserted in the tube 2 by providing the transplant into the distal end of the tube, e.g. by enforcing a flow towards the distal end 3. As an example, the distal end 3 can be connected to a suction device transporting the transplant induced by an over pressure or an under pressure. The flow is then enforced by applying an underpressure to a first end of the tube while the implant is inserted into a second end of the tube. Preferably, the implant is inserted into the tube via the proximal end. In principle, the implant can also be inserted via the distal end, e.g. by applying an underpressure to the proximal end of the tube. Further, the implant can be flown to the tube by applying an over pressure, pressurizing the implant in a flow flowing towards the tube. Once the transplant has arrived in the distal end 3 of the tube, the device can be further prepared by removing the hose or other transport means from the distal end 3 of the tube, and coupling a separate device 5, e.g. an injector, to the proximal end 4 of the tube via the luer lock coupling. During the surgical process, manual operation of the injector enforces the transplant to flow, in a controlled manner, from the distal end 3 of the tube, into the eye.

The invention is not restricted to the embodiments described herein. It will be understood that many variants are possible.

It is noted that the device according to the invention can not only be used for inserting a Descemet membrane into the eye. Also other fragile transplants can be inserted, such as other cell bearing implants or implants including cellular components.

These and other embodiments will be apparent for the person skilled in the art and are considered to lie within the scope of the invention as defined in the following claims.

Claims

1. An ophthalmic surgical device for inserting an implant into a human eye, comprising a tube having a distal end for insertion in the eye and a proximal end, wherein the tube includes a bend between the distal end and the proximal end.

2. An ophthalmic surgical device according to claim 1, wherein the bend is located substantially halfway between the distal end and the proximal end.

3. An ophthalmic surgical device according to claim 1, wherein the bend is located closer to the proximal end than to the distal end.

4. An ophthalmic surgical device according to any of the preceding claims, wherein the inner diameter of the tube has a minimum value near the distal end.

5. An ophthalmic surgical device according to any of the preceding claims, wherein the inner diameter of the tube has a maximum value near the proximal end.

6. An ophthalmic surgical device according to any of the preceding claims, wherein the inner wall of the tube has a smooth surface.

7. An ophthalmic surgical device according to any of the preceding claims, wherein the inner wall of the tube is formed from a glass material or a synthetic material such as PMMA.

8. An ophthalmic surgical device according to any of the preceding claims, wherein the tube is a glass blown product.

9. An ophthalmic surgical device according to any of the preceding claims, wherein the inner wall of the tube includes a polished wall surface.

10. An ophthalmic surgical device according to any of the preceding claims, further including a luer lock connector connected to the proximal end of the tube.

11. An ophthalmic surgical device according to any of the preceding claims, wherein the tube has an elongated structure.

12. An ophthalmic surgical device according to any of the preceding claims, wherein the tube includes a bend.

13. An ophthalmic surgical device according to any of the preceding claims, wherein the smallest diameter of the channel in the tube is circa 2 mm.

14. A method of preparing a device according to claim 1, including a step of inserting an implant into the tube by enforcing a flow towards the distal end of the device.

15. A method according to claim 14, wherein the flow is enforced by applying an underpressure to a first end of the tube and inserting the implant into a second end of the tube.

16. A method according to claim 15, wherein the implant is inserted into the tube via the proximal end.

17. A method according to claim 14, 15 or 16, further comprising a step of connecting a suction device to the distal end of the device.