DEVICE FOR TRANSPLANTING A DESCEMET'S MEMBRANE

20220151766 ยท 2022-05-19

    Inventors

    Cpc classification

    International classification

    Abstract

    The invention relates to a device for the transplantation of a Descemet's membrane-endothelium graft (5), comprising a longitudinal tube (1), the tube (1) having an inner cavity (2), an inlet opening (3) at its proximal end (PE) through which it is possible to introduce the graft (5) into the cavity (2), and an outlet opening (4) at its distal end (DE) through which it is possible to eject the graft (5) from the cavity (2), particularly into the anterior eye chamber of a patient, a guiding element (6) situated in the cavity (2) of the tube (1) extending from the proximal end area of the tube (1) or device towards the distal end area of the tube (1) or device and having an increasing cross section at least along a part of its extension, particularly by increasing the width of the guiding element (6) more than the height of the guiding element (6), wherein the guiding element (6) extending beyond the outlet opening (4) of the tube into the exterior environment of the tube (1), and having the distal end (6b) of the guiding element (6) being positioned outside of the tube (1) in front of the outlet opening (4) of the tube (1).

    Claims

    1. A device for the transplantation of a Descemet's membrane-endothelium graft, the device comprising a longitudinal tube having a proximal end and an opposite distal end, an inner cavity, an inlet opening at it's the proximal end through which it is possible to introduce the graft into the cavity, and an outlet opening at it's the distal end through which it is possible to eject the graft from the cavity into an anterior eye chamber of a patient, a guiding element in the cavity of the tube extending from the proximal end of the tube toward the distal end of the tube and having an increasing cross section at least along a part of its extension increasing a width of the guiding element more than the height of the guiding element, the guiding element extending beyond the outlet opening of the tube externally of the tube, the distal end of the guiding element being outside of the tube in front of the outlet opening of the tube.

    2. The device according to claim 1, the guiding element being formed in one piece with the entire device or the guiding element being formed as an element separate from the tube of the device.

    3. The device according to claim 1, wherein a width of the guiding element increases up to a maximum width of the guiding element in front of the outlet opening of the tube.

    4. The device according to claim 3, wherein a width of the guiding element decreases from the maximum width toward the distal tip of the guiding element.

    5. The device according to claim 1, wherein the distal end of the guiding element outside of the tube is connected or at least connectable to the tube at the upper frontal area of the tube wall at the outlet opening or at the upper exterior surface of the tube wall.

    6. The device according to claim 5, wherein the connection is formed by a protrusion protruding upward from an upper middle surface area of the distal end seen widthwise at a middle surface area with respect to the width of the distal end of the guiding element.

    7. The device according to claim 5 wherein a height of the distal end of the guiding element at the connecting protrusion from the outlet opening decreases toward the tip of the guiding element.

    8. The device according to claim 5, wherein the guiding element is freely floating within the inner free cross section of the cavity without any connection to the inner tube wall along the entire extension of the guiding element in the tube.

    9. The device according to claim 1, wherein the guiding element is connected in its upper area to the upper inner wall of the tube along the majority of the length of the tube.

    10. The device according to claim 1, wherein the guiding element is formed with a spike at its proximal end for feeding a wound-up membrane onto the spike, the proximal end of the guiding element being situated outside of the tube in front of inlet opening of the tube.

    11. The device according to claim 10, wherein the spike is freely floating in the cavity of the tube at the position of the inlet opening of the tube and has no connection to the inner tube wall in the inlet opening.

    12. The device according to claim 1, wherein a lower surface of the inner tube wall extends beyond the outlet opening of the tube toward the external environment of the tube and forms an exterior support surface lying at a spacing below the distal end of the guiding element.

    13. The device according to claim 12, wherein a slit is formed between the exterior support surface and the lower surface of the distal end of the guiding element, the slit being configured for receiving the at least predominantly unrolled Descemet's membrane-endothelium graft after leaving the outlet opening.

    14. The device according to further comprising: an upwardly open gutter outside the tube in front of the inlet opening, a floor of the gutter merging into the inner wall of the cavity of the tube.

    15. The device according to claim 14, wherein the gutter has an increasing height from the proximal end of the device toward the inlet opening of the tube.

    Description

    [0055] The invention will be described on the basis of the following figures showing different sectional views of the preferred embodiments. These sectional views shall depict the qualitative behaviour of the essential features of the inventions. It is not claimed that the sectional views show a correct scaling in their details.

    [0056] In all the figures LV depicts a sectional view of the device in a vertical plane comprising a longitudinal axis, preferably the longitudinal middle axis MA of the device. LH depicts a sectional view of the device in a horizontal plane comprising a longitudinal axis, preferably the longitudinal middle axis MA of the device. CSn depict cross sectional views in planes perpendicular to a longitudinal axis, preferably the longitudinal middle axis MA of the device on n different positions of this longitudinal axis.

    [0057] FIG. 1 shows a first embodiment of a device for the transplantation of a Descemet's membrane. According to the view LV and LH and the cross sectional views CS3, CS4 and CS5 the device comprises a tube 1 having an inner cavity 2, an inlet opening 3 at the proximal end of the tube and an outlet opening 4 at the distal end of the tube 1.

    [0058] It is possible to introduce a Descemet's membrane endothelium graft 5 through the inlet opening 3 into the device. The graft 5 is placed in the state of a single-axis winding around the spike 6a of a guiding element 6. This guiding element 6 is situated in the cavity 2 of the tube 1 and extends from the proximal end PE of the device towards the distal end DE of the device. Particularly, in this embodiment the guiding element 6 extends from an area in front of the inlet opening 3 beyond the outlet opening 4, regarded in the direction of the intended movement of the graft 5 from the inlet opening 3 to the outlet opening 4. Accordingly, the guiding element 6 is longer than the length of the tube 1 and projects out of the tube 1 on both respective ends of the tube 1.

    [0059] The guiding element is increasing in cross section towards the distal end of the device. This is particularly done by increasing the width of the guiding element 6 (regarded in the horizontal plane, see LH) more than the height of the guiding element 6 (regarded in the vertical plane, see LV). This increase of the cross section and particularly of the width of the guiding element 6 performs a spreading of the diameter and a partial unrolling of the graft 5 as can be seen in the different cross sectional views CS6 to CS1. After introducing the wound-up graft 5 into the inlet opening 3 the overlap of the ends of the membrane lying in the winding direction is positioned on top of the winding. When the graft 5 leaves the outlet opening 4 after passing through the tube 1 the predominantly unrolled graft is essentially positioned underneath the guiding element 6, particularly underneath the distal end 6b of the guiding element 6 which is positioned outside of the tube 1 in front of the outlet opening 4.

    [0060] Essentially the view LH shows that the guiding element that extends through the tube 1 beyond the outlet opening 4 reaches its maximum width MW in its distal end 6b that is positioned behind the outlet opening when regarded in the direction of the intended movement of the graft through the device. Accordingly the graft 5 reaches its most unrolled state outside the tube.

    [0061] Regarded again in the direction of the intended movement of the graft 5, i.e. towards the distal tip 6c of the distal end 6b the distal end 6b is decreasing in width and preferably also in height. This facilitates to introduce the distal end 6b of the guiding element 6 into the incision of the anterior eye chamber for introducing the at least partially, preferably predominantly unrolled graft 5 into this chamber.

    [0062] In this embodiment of FIG. 1 the guiding element 6 is totally free floating in the inner cavity of the tube 1, meaning that there is absolutely no connection between the guiding element 6 and the inner wall of the tube 1. As can be seen particularly in the view LV the guiding element 6 is solely connected to the tube 1 at the upper end face/frontal area of the tubular wall with the exterior part of the guiding element forming its distal end 6b.

    [0063] To perform this connection the distal end 6b of the guiding element 6 comprises a protrusion 6d protruding upwards and merging into the end face/frontal area 1a of the tube 1. By integrally merging into the end face 1a this connection is a fixed connection and accordingly the guiding element 6 and the tube integrally formed as one piece.

    [0064] In an alternative embodiment the connection between the protrusion and the tube at its front face 1a may also be releasable, for example by a magnetic connection or a locking means 1c. In this embodiment the guiding element 6 and the tube 1 are separate elements that may be connected to each other at least temporarily, for example during surgery.

    [0065] The guiding element 6 or particularly at least the distal end 6b of it may be understood to have a shape in front of the outlet opening 4 outside the tube 1 in the vertical plane as seen in the view LV that is essentially bent by 150 to 180 degrees.

    [0066] Furthermore in this particular embodiment and shown by the view CS2 the guiding element and its distal end is also free floating in the projection of the outlet opening or the inner free cross section of the tube cavity at least in a part of its extension outside the tube and in front of the outlet opening, proving that the guiding element is passing though the outlet opening 4 without contacting the inner tubular wall in this outlet opening.

    [0067] The outlet opening 4 is arranged in a plane being inclined with respect to the plane perpendicular to the middle axis MA. The position 7 of the outlet opening 4 may be understood to be the intersection between the middle axis MA and the plane of the outlet opening 4 shown in the view LV as a dashed line. In this plane the section of the tube 1 shows a totally closed circumferential line, comparable to the view CS3.

    [0068] In addition FIG. 1 shows that the device comprises a gutter 8 in front of the inlet opening 3, regarded in the direction of movement of the graft 5. The gutter that is open towards the top area of the device facilitates to mount the wound-up graft on the spike 6a of the guiding element 6.

    [0069] Furthermore, the FIG. 1 depicts a handle 9 on top of the tube 1 of the device for an easy handling of the device by a surgeon.

    [0070] With regard to FIG. 2 only the essential inventive differences to FIG. 1 are described. All other elements to which no differences are explained are constructed as shown and described in FIG. 1.

    [0071] As can be seen here in views CS8 to CS6 the height of the gutter 8 is increasing in the direction from the proximal end PE towards the inlet opening 3.

    [0072] An even more essential difference to FIG. 1 is that in the embodiment of FIG. 2 the lower surface of the inner tube wall regarded form the outlet opening 4 towards the distal end of the device is extending beyond the outlet opening thus forming an exterior support surface 1b lying underneath the distal end 6b of the guiding element 6. Accordingly, between the support surface 1b and the lower surface of the distal end 6b of the guiding element a slit 10 is formed that receives the graft and stabilized the predominantly unrolled graft 5 after ejecting out of the outlet opening 4. In FIG. 2 the graft 5 is only shown in the view LV positioned in the mentioned slit 10.

    [0073] As can be seen in the view CS1 the support surface 1b is convex shaped relative to the bottom surface of the distal end 6b of the guiding element, whereas the same support surface 1b is shaped concave in the view CS3. This implies a change in shape from convex to concave in a direction towards the outlet opening 4.

    [0074] Also in this embodiment of FIG. 2 the guiding element 6 is totally free floating in the inner cavity 2 of the tube 1 and solely connected to the upper end face 1a of the tubular wall. Accordingly also here the distal end 6b forms a bent part of the guiding element 6 that passes through the outlet opening 4 into the cavity without any connection to the inner tubular wall.

    [0075] The view LH furthermore shows that the decrease of the width between the position of maximum width MW and the distal tip 6c is performed with a locally smaller rate, particularly in the middle between these two positions, thus forming an undulation/bulge in the tapered front face of the guiding element. At the position of this bulge 6e the gradient of the width has a local maximum with negative sign.

    [0076] In FIG. 3 a third embodiment is shown. Again only the essential differences to FIG. 1 are explained. In this embodiment the guiding element 6 is connected in its upper area, that forms a protrusion 6c, to the inner upper wall of the tube 1. This connection is given along the majority of the length of the guiding element in the tube 1. Only the proximal end 6a of the guiding element 6 forms a free floating spike for mounting the wound-up graft as shown in the view CS6.

    [0077] On its way through the tube 1 the wound up graft 5 is unrolled at an very early stage, what can be seen in the view CSS. The upwards protruding part 6c of the guiding element 6 effects a separation of the overlapping end of the membrane graft 5 thus cancelling the overlap. The graft 5 is still wound around the guiding element 6 until it has left the outlet opening and reaches the maximum width of the guiding element 6 in its distal end 6b.

    [0078] Also in this embodiment the guiding element 6 extends beyond the outlet opening 4 and forms an external distal end 6b outside the tube and in front of this outlet opening 4. Comparable to FIG. 1 also the distal end 6b of the guiding element forms a protrusion 6c that is connected to the end face of the tube 1.

    [0079] The guiding element 6 reaches in its distal end 6b the maximum width at position MW. Between this position MW and the distal tip 6c the distal end is stepwise decreased in width and forms in this horizontal sectional view a frontal face 6f that is oriented perpendicular to the longitudinal extension of the tube 1/guiding element 6 or device. Accordingly, at this step or front face 6f the gradient of the width regarded along the longitudinal extension reaches its local minimum value, for example in this case minus infinity.

    [0080] FIG. 4 just shows the cross sectional view LH of a device in the horizontal plane to depict another inventive shape of the distal end 6b of the guiding element 6. The construction in the vertical plane can be as described in the other figures.

    [0081] In this cross sectional view LH the distal end 6b is shaped in the area between maximum width MW and distal tip 6c essentially semi-circular.

    [0082] The increase in width of the guiding element along its extension reaches its maximum rate, namely the maximum (positive) gradient of the width at the position referred as MG. This position is outside the tube 1 in front of the outlet opening 4.

    [0083] The FIGS. 1 to 4 show an orientation of the device in a typical surgery with a patient lying on his back and looking upwards so that the optical axis of the eye is vertically oriented. It may come up the need to use the device in an inverted orientation in which top and bottom are exchanged. Nonetheless also the inverted device shows the features as described before.