DEVICE FOR THE TRANSPLANTATION OF A DESCEMET'S MEMBRANE

Abstract

A device for the transplantation of a Descemet's membrane includes a longitudinal tube having an inner cavity, an inlet opening through which it is possible to introduce the Descemet's membrane into the device, and an outlet opening through which it is possible to eject the Descemet's membrane from the device, especially into the anterior eye chamber of a patient, wherein the device also includes, at least in the region of the outlet opening, a separation element which protrudes from the inner wall region of the tube into the cavity, especially a first separation element, the separation element dividing the cavity at least regionally, in particular dividing it in a region close to the separation element.

Claims

1. A device for transplantation of a Descemet's membrane, comprising a longitudinal tube having an inner cavity, an inlet opening configured for introduction of the Descemet's membrane into the tube, and an outlet opening configured for ejection of the Descemet's membrane from the device into an anterior eye chamber of a patient, a first separation element which protrudes from an inner wall region of the tube into the cavity at least in a region of the outlet opening, and divides the cavity at least in a region close to the separation element.

2. The device as claimed in claim 1, wherein the first separation element extends in an axial direction of the tube, has respective ends which are proximal and distal relative to the outlet opening, and partially divides the cavity laterally in the region of the outlet opening into two laterally adjacent subcavities, and the proximal end of the first separation element is in a plane of the outlet opening or is spaced from said plane so that the cavity is not divided between the proximal end of the separation element and the outlet opening.

3. The device as claimed in claim 2, wherein said end of the separation element is in the plane of the outlet opening.

4. The device as claimed in claim 1, wherein the tube has at least in the region of the outlet opening an outer cross section in a plane orthogonal to the axis of the tube which is oval or elliptic and vertical height dimension and a horizontal dimension which is larger than the vertical height dimension, the oval or elliptic cross-section being configured for the vertical height dimension to be oriented in a direction of height of the patient and the horizontal dimension to be oriented in a direction of width of the patient's anterior eye chamber.

5. The device as claimed in claim 2, wherein the end of the separation element proximate the outlet opening a recess oriented away from the outlet opening in the arial direction of the tube.

6. The device as claimed in claim 1 wherein, at least in a region adjacent the outlet opening, in cross-sections of the tube orthogonal to the tube axis the inner wall of the tube is wavy.

7. The device as claimed in claim 2, further comprising a second separation element which is situated opposite the first separation element and protrudes into the cavity from an inner wall region of the tube opposite the inner wall region from which the first separation element protrudes into the cavity and divides the cavity laterally at least in a region close to the second separation element.

8. The device as claimed in claim 2, wherein the first separation element comprises, contiguous with the proximal end thereof, two arms, each extending laterally in a direction opposite from the other, the first separation element being symmetrical about an axial plane of the tube.

9. The device as claimed in claim 8, wherein each of the arms curves away from the outlet opening and has a free end pointing away from the outlet opening.

10. The device as claimed in claim 7, wherein the second separation element extends in the axial direction of the tube and has respective ends which are proximal and distal relative to the outlet opening.

11. The device as claimed in claim 10, wherein, in the axial direction of the tube from the outlet opening toward the inlet opening, cross-sections of at least one of the first and second separation elements in planes orthogonal to the tube axis are of a same shape but decrease in size.

12. The device as claimed in claim 11, wherein the axis of the tube is in a plane of symmetry of the first separation element and the tube.

13. The device as claimed in claim 12, wherein the at least one of the first and second separation elements having cross-sections orthogonal to the tube axis which decrease in size from the outlet opening toward the inlet opening comprises the first separation element, and the first separation element is connected to the inner wall only at a region of the inner wall one end of which region in the axial direction of the tube is proximate the inlet opening and the other end of which in the axial direction of the tube is spaced from the outlet opening, and the first separation element is thereby formed as a spike configured to receive the membrane wound up as a single winding.

14. The device as claimed in claim 13, wherein the region at which the first separation element is connected to the inner wall comprises 75% of total, axial length of the tube.

15. The device as claimed in claim 11, wherein the at least one of the first and second separation element having cross-sections orthogonal to the tube axis which decrease in size from the outlet opening toward the inlet opening comprises the second separation element, and the decrease in size comprises decrease in dimension of the cross-sections of the second separation element orthogonal to the tube axis.

16. The device as claimed in claim 7 further comprising a channels formed in the tube between the inner and outer walls of the tube or in the first or second separation element and which channel extends in the axial direction of the tube and opens in the plane of the outlet opening of the tube and is configured for pushing of air therethrough into the region of the outlet opening.

17. Hie device as claimed in claim 16, further comprising an inlet opening of the channel which inlet opening is configured to receive tubing connected to a syringe for pushing air into the channel.

18. The device as claimed in claim 7, further comprising a guide extending in the axial direction of the tube and configured to mount a respective one of the first and second separation elements thereon for sliding of the separation element in the axial direction of the tube within at least a region of the tube and extending outside the tube beyond the plane of the outlet opening.

19. The device as claimed in claim 2, further comprising respective unrolling aids each facing a respective one of the subcavities and configured to aid in effecting unrolling of a respective winding of the membrane situated in the respective subcavity.

20. The device as claimed in claim 1, wherein the proximal end of the separation element is in the plane of the outlet opening.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1 shows a device according to the prior art;

[0049] FIG. 2 shows an embodiment of the invention having a first separation element;

[0050] FIG. 3 shows an embodiment of the invention having first and second separation elements;

[0051] FIG. 4 shows an embodiment of the invention having a first separation element of another configuration and a second separation element;

[0052] FIG. 5 shows an embodiment of the invention having a first separation element of yet another configuration and a second separation element;

[0053] FIG. 6 shows a preferred embodiment of the invention in axial cross-section;

[0054] FIGS. 6A, 6B, 6C, 6D and 6E are respective cross-sections of the embodiment of FIG. 6 taken on respective planes A-A, B-B, C-C, D-D, and E-E perpendicular to the plane of FIG. 6;

[0055] FIG. 7 shows another embodiment of the invention in cross-section taken on the plane of the outlet opening of the tube;

[0056] FIG. 8 shows yet another embodiment of the invention in cross-section taken on the plane of the outlet opening of the tube; and

[0057] FIG. 9 shows yet another embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0058] FIG. 1 shows a device according to the prior art with a view of the outlet opening, comprising a tube 1 having a circular cross section. What can be visualized therein is a Descemet's membrane 2 which is wound up to form a single-axis winding and which is introducible as transplant into the anterior chamber of an eye. Evidently, the membrane retains its single-axis form and is inserted as such into the anterior chamber and unrolled therein with the disadvantages mentioned at the start.

[0059] In the simplest embodiment, it can be envisaged in the invention to introduce the membrane, already as a double-axis winding, into the device and to stabilize it therein according to the embodiment of FIG. 2 and the following figures. Similarly, it is possible to introduce the membrane as a single-axis winding into the device and to transfer it therein to the double-axis wound form by forward pushing, especially as will be explained below on the basis of FIG. 6.

[0060] FIG. 2 shows a tube 1 having a flattened radial (i.e., in a plane orthogonal to the tube axis) cross section, i.e., in the vertical height direction H, the tube 1 is smaller than in the lateral (horizontal) direction. In all the figures, the tube can be seen to be oriented substantially horizontally, this corresponding to the customary position in an operation. All the cross sections shown are perpendicular to the longitudinal extent, apart from the section in the middle of FIG. 6.

[0061] From the upper region of the inner wall, a separation element 4 extends in a downward direction into the cavity of the tube 1 and divides the cavity, at least in the upper region, into two subcavities 3a and 3b. Said separation element 4 fits between the two subwindings 2a and 2b of an inserted membrane 2 and thus prevents the subwindings from being able to unroll over one another and from thereby automatically reshaping the membrane to form a single-axis winding.

[0062] What can be visualized in FIG. 3 is a further development by lengthening the inner circumference of the inner wall of the tube 1 by a second separation element 5, which also laterally divides the cavity of the tube 1 in the lower region. Owing to the part of the second separation element 5 that is rising as a projection, a membrane surface region 2c connecting the two windings is shifted upward and each of the two windings is thus further unwound.

[0063] The two separation elements directly face each other and are preferably symmetrical around the vertical plane E running in the axial direction.

[0064] What can be visualized in FIG. 4 is a further embodiment in which the first separation element 4 viewed in cross section branches perpendicularly to the axial direction of the tube to form two opposing sides and forms arms 4a and 4b, which point downward here in an arm starting region. Here, the branching preferably starts in the region of the central axis of the tube 1.

[0065] FIG. 5 shows a further development in which each of the arms 4a, 4b is curved in an upward direction at its end. As a result, each of the arm ends engages in the respective subwinding of the membrane 2. This generates a maximum guidance of the membrane surface in the spatial region remaining free between the separation elements 4 and 5 and forces the membrane to the at least partial unwound state, and so its further unwinding after introduction into the anterior chamber of an eye is substantially simplified.

[0066] What can be visualized in FIGS. 1 to 5 is the configuration of the devices in a cross-sectional plane in the region of the outlet opening. However, the shaping shown is exhibited by the separation elements not only here, but also in an axial direction of extension proceeding from the outlet opening in the direction of the inlet opening, with the cross-sectional area of the two separation elements decreasing in this direction.

[0067] FIG. 6 shows this configuration on a preferred embodiment of the invention firstly in a central vertical cut made along the central axis MA of the tube 1 and at multiple sectional positions perpendicular thereto.

[0068] It can be seen in the middle section of FIG. 6 that the second separation element 5 rises in height above the outer wall of the tube 1 in the direction of the outlet opening 6 (rightwards here). The first separation element 4 is formed around the central axis MA of the tube 1 over the overwhelming part of said element's axial extent, if not entirely, and, in this connection, is only connected to the upper inner tube wall in a part 7 close to the outlet opening 6 and floating freely in the cavity in the region close to the inlet opening 8, forming there a spike 9 which tapers in the cross section and on which the Descemet's membrane can be slid as a single-axis winding. The first and/or the second separation element 4, 5 can be of the same material as the tube wall, in particular form one piece therewith.

[0069] FIG. 6E shows, in section E-E of FIG. 6, the inlet opening with a completely free cross section and FIG. 6D shows, in section D-D of FIG. 6, this single-axis winding of the membrane 2 in the arrangement around the spike 9 of the first separation element 4.

[0070] If, then, the membrane 2 in the device is moved in the direction of the outlet opening 6, the cross-sectional broadening of the first separation element 4 causes the winding to spread open from the inside and the membrane surface overlap to decrease as result, as shown by FIG. 6C, which is section C-C of FIG. 6.

[0071] With further forward pushing, the shaping of the first separation element 4 causes the membrane overlap to be removed and two subwindings 2a, 2b to form in the region of the upper subcavities between the arms 4a, 4b and the tube wall, as illustrated by FIG. 6B, which is section B-B of FIG. 6. Here, the subwindings 2a, 2b can themselves still be overlapping.

[0072] The rising second separation element 5, which also laterally divides the tube cavity in the lower region, causes a further unwinding of the membrane 2 by shifting the membrane 2 upward in the region between the subwindings, as shown by FIG. 6A, which is the section A-A at the outlet opening of FIG. 6. This sectional representation substantially corresponds to the representation in FIG. 5.

[0073] It can be clearly seen that the device in this embodiment offers the advantage of inserting a membrane 2 as a single-axis winding into the device and of being able to introduce it as a partially unrolled double-axis winding into the anterior chamber of the eye, the conversion from the single-axis winding to the double-axis winding being effected automatically in the device by the guidance of the membrane surfaces between the separation elements 4, 5 and the spatial regions formed therebetween.

[0074] In this connection, the configuration can be effected such that the inner circumferential length of the tube, which is formed in the regions between both separation elements 4, 5 and the first separation element 4 and the inner wall of the tube 1, is greater than the diameter of the membrane 2, in particular is greater than 8 or even 9 mm, and so there are no more directly overlapping membrane surface regions in a membrane 2 guided in the device.

[0075] In particular, this can be achieved when the cross section perpendicular to the tube-based longitudinal axis of the free spatial region in the tube that is formed for membrane guidance corresponds, at least in the region of the outlet opening, to the shape of a W, of a wave or of the small Greek letter omega ().

[0076] FIG. 7 shows a possible further development, according to which a channel is arranged in the tube in the lower region, preferably in the wall thickness around the vertical central plane, the mouth opening 10 of said channel being in the annular end face at the outlet opening, in this case preferably even within the cross-sectional area of the second separation element.

[0077] The channel can lie longitudinally in the direction of the tubular extent and be used to spray air under the membrane. For this purpose, the channel can be connectable to a syringe, for example via an external tubing connector into which the channel merges.

[0078] FIG. 8 discloses a further alternative in which all the features of the embodiments so far can be realized with the exception of the second separation element, which is not envisaged here. Guidance of the membrane over the first and sole separation element 4 is enough to be able to cause the membrane in the lower surface region connecting the two subwindings to automatically fold upward owing to inner tensions, without a second separation element being required for this purpose. Nevertheless, the first separation element has in its lower region, especially where it branches in this embodiment, an upwardly pointing recess 11 into which this membrane surface region can enter.

[0079] As in the case of FIG. 7, it would also be possible here for a channel opening 10 to lie in the lower tube wall within the wall thickness; however, it is not visualized here.

[0080] FIG. 9 shows one embodiment in which the separation element 4 is slidably arranged in a guide 12 formed between the tube and the separation element 4. As a result, the separation element 4 can be slid in the axial direction of the tube out of its outlet opening.

[0081] In addition, it is possible to see here the further development where an unrolling aid 13 is arranged on both sides of the separation element 4 and facing the respective subcavities 3a and 3b. Here, the unrolling aid 13 is designed as an expandable balloon 13 which can be supplied with a fluid from the outside via a channel in the separation element that is not shown.

[0082] When the balloon 13 expands, it pushes out the respective winding of the membrane and causes its unrolling.