DEVICE FOR THE PREPARATION OF A DESCEMET'S MEMBRANE-ENDOTHELIUM GRAFT

Abstract

A device for the preparation of a Descemet's membrane-endothelium graft includes a bowl with an inner bottom and a sidewall surrounding the bottom, particularly the bowl being configured to receive a fluid and a Descemet's membrane-endothelium graft or a donor cornea graft comprising a Descemet's membrane-endothelium graft floating in the fluid, a preparation area positioned in a first part of the inner bottom of the bowl, particularly for receiving and preparing the graft prior to transport, a transfer area positioned in a second part of the inner bottom between the preparation area and an outlet opening in the sidewall, particularly the opening being entirely positioned below the upper rim of the sidewall.

Claims

1. Device for the preparation of a Descemet's membrane-endothelium graft comprising a. a bowl with an inner bottom and a sidewall surrounding the inner bottom, the bowl being configured to receive a fluid and a Descemet's membrane-endothelium graft or a donor cornea graft comprising a Descemet's membrane-endothelium graft floating in the fluid, b. a preparation area located in a first part of the inner bottom, the preparation area being configured for receiving and preparing the graft prior to transport, and c. a transfer area located in a second part of the inner bottom between the preparation area and an outlet opening in the sidewall, outlet opening being entirely located below an upper rim of the sidewall, wherein the bowl comprises a base configured for placing the bowl on a support, the base being configured to provide a first stable position of the bowl for preparing the graft and a second stable position of the bowl for transferring the prepared graft towards the outlet opening.

2. The device according to claim 1, wherein the preparation area comprises a recess, an inner surface of the recess being located below an area of the inner bottom surrounding the recess.

3. The device according to claim 2, wherein the inner surface of the recess further comprises at least one opening, the at least one opening being in fluid connection with a channel in the bowl configured for extracting fluid out of the recess.

4. The device according to claim 2, wherein the preparation area is formed by a separate bottom element configured to be insertable into the inner bottom and removable out of the inner bottom.

5. The device according to claim 4, wherein the bowl comprises a hollow chamber underneath the inner bottom, the hollow chamber being open towards the inner bottom and configured for receiving the separate bottom element, the channel merging into the hollow chamber.

6. The device according to claim 1, wherein the transfer area is increasing in height towards the outlet opening in the first stable position of the bowl.

7. The device according to claim 1, further comprising a transport device, and wherein the outlet opening in the sidewall leads into a connector to which the transport device is at least temporarily attachabled, particularly the transport device being configured to receive the prepared graft for transport purposes.

8. The device according to claim 7, wherein the outlet opening, the connector and/or the attached transport device is positioned higher than the preparation area at least in the first stable position of the bowl.

9. The device according to claim 1, wherein the upper rim of the sidewall surrounding the transfer area is increasing in height towards the outlet opening at least in the first stable position of the bowl.

10. The device according to claim 1, wherein a height of the sidewall above the inner bottom is constant throughout or increasing toward the outlet opening.

11. The device according to claim 1, wherein the first part of the inner bottom comprises a first plane surface area surrounding the preparation area and the second part of the inner bottom comprises a second plane surface area which is a part of the transfer area, the second plane surface area rising in height towards the outlet opening at least in the first stable position of the bowl.

12. The device according to claim 11, wherein in a top view of the bowl the second surface part is tapered towards the outlet opening.

13. The device according to claim 1, wherein a lower-surface of the base comprises a. a plane first lower surface part underneath the preparation area and a plane second lower surface part underneath the transfer area, the second lower surface area rising in height in a direction towards the outlet opening, or b. a first lower surface part underneath the preparation area having a first set of at least three contact elements and a second lower surface part underneath the transfer area having a second set of at least three contact elements, tips of the first set of contact elements being located in a first plane and tips of the second set of contact elements being located in a second same, the second plane rising in height in a direction towards the outlet opening.

14. The device according to claim 13, wherein the lower surface of the base is configured so that in the first stable position the bowl is positioned on a support with the plane first lower surface part or the contact elements of the first lower surface part contacting the support and in the second stable position the bowl is positioned on the support with only the plane second lower surface part or the contact elements of the second lower surface part contacting the support.

15. The device according to claim 1, further comprising a wrist support shaped as a ring or frame being open in a single circumferential position, the wrist support being configured for receiving the bowl in the first stable position for preparing a graft.

16. The device according to claim 3, wherein the at least one opening comprises a plurality of openings.

17. The device according to claim 3, wherein the inner surface of the recess further comprises at least one opening, the at least one opening being in fluid connection with a channel in the bowl configured for extracting fluid out of the recess.

18. The device according to claim 17, wherein the preparation area is formed by a separate bottom element configured to be insertable into the inner bottom and removable out of the inner bottom.

19. The device according to claim 18, wherein the bowl comprises a hollow chamber underneath the inner bottom and being open towards the inner bottom and configured for receiving the separate bottom element, the channel merging into the hollow chamber.

20. The device according to claim 7, further comprising an applicator configured to eject the graft, and wherein the transport device is configured to be connected to the applicator after transport to the applicator.

21. The device according to claim 12, wherein the tapered second surface part forms a funnel, the first surface part being at least partially circular.

Description

[0037] A preferred embodiment of the invention is shown in several figures and will be describe commonly for all figures hereinafter.

[0038] FIG. 1 shows a top view of the device.

[0039] FIG. 2 shows a side view of the device.

[0040] FIG. 3a shows a cross sectional view along line B-B of the bowl in a first stable position standing on a horizontal table

[0041] FIG. 3b shows a cross sectional view along line B-B of the bowl in a second stable tilted position standing on a horizontal table

[0042] FIG. 4 shows an isometric view with a wrist support

[0043] FIG. 5 shows a front view

[0044] FIG. 5A shows a bottom view with plane lower surface parts of the base

[0045] FIG. 5B shows a bottom view with tripods in the respective lower parts of the base

[0046] FIG. 6 shows in a perspective view the possibility to attach the transport device to a first kind of applicator for surgery

[0047] FIG. 7 shows the transport device and the first kind of applicator in different views

[0048] FIG. 8 shows in a perspective view the possibility to attach the transport device to a second kind of applicator for surgery

[0049] FIG. 9 shows the transport device and the second kind of applicator in different views.

[0050] All figures show a device of the invention comprising a bowl 1. The bowl is formed by the inner bottom 2 and the sidewall 3 entirely surrounding the bottom 2 at its circumferential periphery. The bottom 2 is subdivided into a first part 2a and a second part 2b. The first part 2a comprises a preparation area 4. The second part 2b together with the respective part of the sidewall 3 form the transfer area 5 that is situated between the preparation area 4 and the outlet opening 6.

[0051] In this embodiment the preparation area is formed by a separate element 7 that comprises a recess 7a being the lowest part of the inner volume of the bowl in the shown position, particularly in a first stable position of two different stable positions. In particular in all possible embodiments the preparation area is an area in the bowl comprising the lowest part of the bowl in the first position. The separate element 7 is inserted into a chamber 8 of the bowl 1 that furthermore provides a fluid connection between the channel 9 in the base 10 of the bowl and the opening 7b in the recess 7a by attaching a pump or a syringe to the channel 9 a fluid may be extracted from the recess. The fluid may be air and the graft be fixed by suction. The graft may also be floating in the recess 7a in a liquid and may also be fixed in it by suction.

[0052] FIGS. 2 and 3a/b depict that the transfer area 5, particularly the second part 2b of the inner bottom 2 is increasing in height towards the outlet opening 6, particularly at least in the shown first position in FIG. 3a of two different positions, the second position being shown in FIG. 3b. The top view of FIG. 1 furthermore depicts that the second part 2b is tapered towards the outlet opening 6 thus forming of funnel leading into the opening 6.

[0053] The sidewall 3 at the position of the opening 6 comprises a connector 11 to which a transport device 12 is releasable attached.

[0054] FIGS. 2 and 3a/b furthermore show that the base 10 of the bowl 1 has a first plane lower surface 10a. This first lower surface 10a is used to place the bowl 1 on a supporting surface 13, for example a horizontal table in a first stable position in which the bowl 1 is used for preparing a graft in the preparation area 4. This first position is shown in the FIGS. 1, 2, 3a, 4 and 5.

[0055] The base 10 furthermore has a second plane lower surface 10b. This second lower surface 10b is used to place the bowl on a supporting surface 13 in a second stable position in which the bowl is used to transfer the graft towards the outlet opening 6.

[0056] This second stable position of the bowl is shown in FIG. 3b.

[0057] Instead of first and second plane lower surfaces the respective lower surface may have contact elements, preferably at least three, the contact elements of a respective lower surface all being in the same plane. An embodiment showing the respective plane lowers surfaces 10a/10b of the base 10 is shown in the FIG. 5A. An alternative embodiment in which the respective lower parts 10a and 10b of the base 10 each comprises three contact elements 10c forming a respective tripod is shown in FIG. 5B.

[0058] Inclining the bowl from the first to the second position automatically decreases the height of the opening 6 above the support surface 13 and leads to a flow of the liquid in the bowl 1 towards the opening 6 that is carrying the prepared graft also towards the opening 6 and into the transport device 12. Both positions in the FIGS. 3a and 3b are stable positions of the bowl 1 on the supporting surface 13 due to the fact that the center of gravity of the liquid filled bowl 1 is moving by inclining the bowl 1 from a position above lower surface 10a to a position above lower surface 10b of the base 10.

[0059] This transfer can be done entirely without an additional tool what is the big advantage of this device over the state of the art. This transfer can also be done by using a tool for gently pushing the graft floating in the liquid. The transfer can also be done by drawing the liquid into the transfer device using the transfer device.

[0060] The height of the sidewall 3 can be the same in any circumferential position but is in this embodiment increasing towards the opening 6. Essentially the first part 2a of the inner bottom 2 may comprise a surface area being parallel to the first lower surface 10a of the base 10 and the second part 2b of the inner bottom 2 may comprise a surface area being parallel to the second lower surface 10b of the base 10.

[0061] FIG. 4 shows an annular wrist support 14 surrounding the bowl 1 facilitating the handling of the bowl 1 in the first position. The wrist support may have a recess underneath the opening 6 of the bowl 1 in order to facilitate that this opening may be lowered and moved into the recess when inclining the bowl from the first into the second stable position.

[0062] After transferring the graft into the transport device 12, the transport device 12 may be detached from the connector 11, for example a Luer-lock. The graft in the transport device 12 may be transported to direct surgery or longer storage. For this purpose the transport device 12 may be hermetically closable, preferably re-openable prior to surgery.

[0063] Preferably, as shown in FIG. 6 the transport device 12 is configured to get also attached to the distal end 15b of an applicator 15 for ejecting the graft directly through the applicator 15 into the anterior eye chamber of a patient. FIGS. 6 and 7 show a first possible embodiment of an applicator.

[0064] For that purpose in the shown preferred embodiment the applicator 15 is configured at its distal end 15b to get connected to the transportation device 12 and at its proximal end 15a to get inserted into the anterior eye chamber through an incision.

[0065] The applicator 15 may furthermore comprise a guiding element 15c being situated in the tube of the applicator and extending out of the tube of the applicator 15 beyond its outlet opening 15d. This guiding element 15c is shown in more detail in the views of FIG. 7, particularly the cross sectional view.

[0066] Such applicator 15 is disclosed as a device for the transplantation of a Descemet's membrane-endothelium graft in applicants own patent application EP 19161116.9

[0067] As far as admissible by national law the disclosure of EP 19161116.9 is incorporated by reference.

[0068] In addition FIG. 8 and FIG. 9 show the possibility to connect the transport device 12 to a second embodiment of an applicator 15, the applicator essentially being formed as a tube having a connector at its distal end for connecting to the transport device 12, the tube being tapered and flattened towards the ejection opening at the distal end 15a. The applicator 15 of FIGS. 8 and 9 does not have a guiding element.