IMPLANT

Abstract

An implant with which prostates of different sizes can be treated is achieved by the fact that the length of a deployed implant is modifiable to a variable extent. Through the change of length of a stretched-out wire structure of the implant, the implant can be adapted individually to the patient anatomy and the outcome of treatment can thus be improved.

Claims

1. A removable implant for treating a urinary tract of a person by application of a local ischemic pressure to the tissue of urinary organs by a wire structure with at least two wires, the implant in a folded state being insertable, with a distal end to the front, into the urethra and being deployed to provide the wire structure in the urethra in order to treat the tissue, wherein the length of the deployed implant is modifiable to a variable extent.

2. The removable implant as claimed in claim 1, wherein a sleeve is able to be pushed over a proximal end region of the at least two wires, this sleeve being freely displaceable over the proximal end region of the wires.

3. The removable implant as claimed in claim 1, wherein the sleeve is rigidly connectable to the at least two wires, a relative movement between the wires and the sleeve being suppressed by the rigid connection.

4. The removable implant as claimed in claim 1, wherein the sleeve is a screw type sleeve, a crimp sleeve, a click fit sleeve, a latching sleeve or a sleeve having an inner passage whose diameter corresponds precisely to the sum of the diameters of the wires.

5. The removable implant as claimed in claim 1, wherein the length of the implant is adjusted by the positioning of the sleeve on the at least two wires, the length of the deploying portion of the wires being set by the fixing of the sleeve on the wires.

6. The removable implant as claimed in claim 4, wherein the screw type sleeve can be assembled from a first part and a second part, the first part having an inner thread and the second part having a sleeve with an outer thread, the second part being able to be screwed together with the first part, and an elastic ring being able to be clamped between the two parts.

7. The removable implant as claimed in claim 1, wherein the sleeve is able to be fixed to the wires outside the person before the treatment or inside the person during the treatment.

8. The removable implant as claimed in claim 1, wherein the sleeve is able to be fastened releasably to the wires.

9. The removable implant as claimed in claim 1, wherein the sleeve has an external diameter of less than 3 mm.

10. The removable implant as claimed in claim 1, wherein at least one of the wires, or a holding element of the implant, has markings, on the basis of which the length of the implant or the position of the sleeve is adjustable.

11. A removable implant for treating a urinary tract of a person by application of a local ischemic pressure to the tissue of urinary organs by a wire structure with at least two wires, the implant in a folded state being insertable, with a distal end to the front, into the urethra and being deployed to provide the wire structure in the urethra in order to treat the tissue, and having a holding element, by which the position of the implant inside the urinary tract is able to be fixed, wherein the length of the holding element is modifiable to a variable extent.

12. The removable implant as claimed in claim 11, wherein a sleeve as is able to be pushed over a proximal end region of the holding element.

13. The removable implant as claimed in claim 11, wherein the holding element has, at a distal end, predetermined breaking points, by which the length of the holding element can be changed in a targeted manner.

14. A removable implant for treating a urinary tract of a person by application of a local ischemic pressure to the tissue of urinary organs by a wire structure with at least two wires, the implant in a folded state being insertable, with a distal end to the front, into the urethra and being deployed to provide the wire structure in the urethra in order to treat the tissue, and having a holding element, by which the position of the implant inside the urinary tract is able to be fixed, wherein, as per claim 1, the length of the implant and the length of the holding element are modifiable to a variable extent.

Description

[0018] A preferred exemplary embodiment of the present invention is explained in more detail below with reference to the drawing. In this drawing:

[0019] FIG. 1 shows a view of a deployed implant,

[0020] FIG. 2 shows a view of the implant in the folded-up state,

[0021] FIG. 3 shows a view of the implant in the deployed state,

[0022] FIG. 4 shows a view of the implant in the shortened, folded-up state,

[0023] FIG. 5 shows a view of the implant in the shortened, deployed state, and

[0024] FIG. 6 shows a sectional view of an exemplary embodiment of a sleeve.

[0025] FIG. 1 illustrates a possible exemplary embodiment of an implant 10. It is expressly noted that this example is just one of many possible embodiments.

[0026] The exemplary embodiment of the implant 10 shown in FIG. 1 has a wire structure 11 with three wires 12. However, embodiments with two or four or more wires 12 are also conceivable. It has nonetheless been found that three wires 12 are particularly well suited for manipulating the tissue of the urethra. These wires 12 are advantageously wires made of stainless steel, a spring steel or a shape-memory material. Alternatively, it is also conceivable that the wires 12 are designed as plastic rods. Thus, in a particularly advantageous exemplary embodiment, provision is made that the plastic is biodegradable. The implant 10 thus at least partially breaks up after a certain time within the body, and therefore a further intervention for recovering the implant 10 is not needed.

[0027] The wires 12 are connected to one another at their distal ends 13. The opposite, proximal ends 14 of the wires 12 are brought together in a common connection body 15. This connection body 15 is shown as a ball in the figures, but it can also have any other shape. A holding means 16 is arranged proximally on the connection body 15. This holding means 16, which can be designed as a thread, as a flexible wire or as a pin, serves in particular for placing the implant 10 in the urethra and also for withdrawing the implant 10 from the urethra after treatment has been competed. Accordingly, the holding means 16 is guided out of the body during the treatment.

[0028] FIG. 1 also illustrates, highly schematically, a tongue-like holding element 17. After the implant 10 has been correctly positioned in the urethra, this holding element 17 engages in the tissue and serves for fixing the implant 10 in the region to be treated. This holding element 17 can preferably be made from the same material as the wires 12 and is likewise connected to the holding means 16. On account of the tongue-like shape of the holding element 17, the latter acts like an anchor for the implant 10. By pulling it back a short distance in the proximal direction after the positioning of the implant 10, the holding element 17 is fixed in the tissue.

[0029] In the exemplary embodiment in FIG. 1, the sleeve 19 according to the invention is also shown. This sleeve is a hollow cylinder which is pushed over the proximal ends 14 or over the proximal region of the wires 12. Initially, i.e. before the treatment, this sleeve 19 is freely displaceable over the wires 12. For setting a defined length of the implant 10 or of the wire structure 11, the sleeve 19 can be moved to and fro along the folded wires 12 and fixed at a suitable position. The distance between the distal end 13 and the sleeve 19 then defines the length of the stretched-out implant 10. In the exemplary embodiment shown in FIG. 1, the sleeve 19 is positioned directly in front of the connection body 15, i.e. the sleeve 19 encloses the proximal ends 14 of the wires 12. As a result of this positioning of the sleeve 19, the wire structure 11 stretches to its maximum length. The length of the implant 10 or of the wire structure 11 can be determined according to the size of the prostate. This size or length of the prostate is determined prior to the treatment, such that, even before the implant 10 is inserted into the body of the patient, the optimal length of the wire structure 11 is adjustable by displacement and fixing of the sleeve on the wires 12.

[0030] For the treatment of BPH syndrome, the implant 10 is first inserted in the folded state into the patient's urethra through a tubular catheter 18, as is shown schematically in FIG. 2. In the exemplary embodiment according to FIGS. 1 and 2, the sleeve 19 is situated at the proximal end 14 of the wires 12, such that the wire structure 11 has a maximum length. As soon as the catheter 18 has been brought to the correct position inside the urethra, the implant 10 is pushed out of the catheter 18 and, if appropriate, the catheter 18 is at the same time pulled in the proximal direction out of the urethra. As a result of the material that is chosen, the wires 12 outside the catheter 18 stretch out to form the wire structure 11 shown in FIG. 1, specifically as far as the sleeve 19. Alternatively, it is also conceivable that the wires 12 are stretched out to form the wire structure 11 by means of an axial pull on the holding means 16. If, during the stretching out of the wire structure 11, the implant 10 shifts away from the optimal position, it is possible to move the implant 10 back to the correct position.

[0031] As soon as the wire structure 11 has reached the optimal shape or the maximum expansion for treating the tissue and the holding element 17 has anchored itself in the tissue, the catheter 18 is pulled in the proximal direction out of the urethra. By virtue of the anchoring provided by the holding element 17, the implant 10 remains at the predetermined position, the holding means 16 being guided out of the urethra (FIG. 3). After the treatment has been completed, the catheter 18 is inserted again into the urethra via the holding means 16, and the stretched-out wire structure 11 is pulled back through the holding means 16 into the catheter 18, the wires 12 being pulled together on the circumference of the catheter 18. In the folded-together state, the implant 10 in the catheter 18 can be pulled back out of the urethra.

[0032] For treatment of a smaller prostate, the length of the implant 10 can be varied. It will be seen from FIG. 4 that the sleeve 19 has been displaced in the distal direction compared to the exemplary embodiment according to FIGS. 1 to 3. The sleeve 19 is not only displaced in the distal direction but also fixed at this position. This positioning of the sleeve 19 and its fixing take place outside the catheter 18 in accordance with the determined size of the prostate. Apart from the position of the sleeve 19 on the wires 12, no other changes have been made in relation to the exemplary embodiment according to FIGS. 1 to 3. As the implant 10 is guided out of the catheter 18, the wires 12 stretch out equally, as described above, but only as far as the sleeve 19. The sleeve 19 suppresses complete deployment of the implant 10. Thus, in the exemplary embodiment of FIG. 5, the implant 10 is accordingly shorter. This shortened length of the implant 10 is tailored to the size of the prostate that is to be treated. As a result of this adjustment of the length of the wire structure 11, no other tissues or muscles or the like are accidentally damaged during the treatment. Rather, this adjusted length ensures that pressure is applied to precisely the region that is to be treated.

[0033] Just like the length of the wires 12, the length of the tongue-like holding element 17 can also be varied. The holding element 17 can equally be guided through the sleeve 19. Exemplary embodiments are conceivable in which only the holding element 17 is guided through the sleeve 19 and the wires 12 in their stretched out state are not affected, or the wires 12 are guided together with the holding element 17 through the sleeve 19. If only the holding element 17 is guided through the sleeve 19 and shortened in length, it is not the length of the implant 10 that is changed but the position at which the implant 10 is fixed inside the bladder neck. The implant 10 can protrude into the bladder but will not come into contact with the external sphincter.

[0034] To ensure that the implant 10 maintains its adapted length during the treatment, it is extremely important that the sleeve 19 is rigidly connectable to the wires 12 and/or the holding element 17. It is only through this rigid connection that the wires 12 stretch distally from the sleeve 19, specifically without the sleeve 19 being displaced in the proximal direction. For this fixing of the sleeve on the wires 12, different embodiments of the sleeve 19 are provided. FIG. 6 illustrates a possible exemplary embodiment. The sleeve 19 is composed of a first part 20 and a second part 21. These two parts 20, 21 are designed like hollow cylinders and can be screwed into one another. Moreover, the two parts 20, 21 have a passage 22 through which the wires 12, which are shown by way of example in the exemplary embodiment according to FIG. 6, and/or the holding element 17 can be guided. The first part 20 has an inner thread 23, which corresponds with an outer thread 24 of the second part 21. The outer thread 24 of the second part 21 is arranged on a region which has a reduced diameter and which can be screwed into the first part 20. Moreover, an elastic ring 25 is positioned between the first part 20 and the second part 21. When the first part 20 is screwed together with the second part 21, this elastic ring 25 is compressed, such that the free passage 22 is reduced. By this deformation of the ring 25, wires 12 inside the sleeve 19 are fixed, and therefore a relative movement between the wires 12 and the sleeve 19 is suppressed.

[0035] Provision is made that the sleeve 19 is screwed together outside the catheter 18 prior to the treatment. It is conceivable that markings are located on the wires 12 in order to give the operating surgeon an indication of where the sleeve is to be placed. With the aid of the markings, a defined length of the implant can be set. It is equally conceivable that the sleeve 19 is screwed together inside the catheter. For example, even after the implant 10 has been placed in the urethra, the screw connection can be opened during the treatment and, after the sleeve has been displaced on the wires 12, can be screwed together again, such that the length of the implant 10 can be actively changed during the treatment. For this purpose, it is conceivable that the sleeve 19 inside the urethra is gripped and actuated using a special tool.

[0036] In an alternative embodiment of the sleeve, provision can be made that it is designed as a click-fit or latching sleeve. In this case, two parts are not screwed together as described above with reference to FIG. 6, and instead they click or latch onto each other. In a further embodiment of the sleeve, provision can be made that it is designed as a crimp sleeve. The crimp sleeve is guided over the wires 12 outside the body, prior to the treatment, and pressed using a crimping tool. A crimp connection of this kind provides particularly reliable fixing of the sleeve and, in addition, is particularly favorable in terms of its production.

[0037] Independently of its design, the sleeve 19 can produced from a metal, plastic or a ceramic. The diameter of the sleeve 19, or of the two parts 20, 21, is largely dictated by the internal diameter of the catheter 18 but is generally less than 3 mm. Embodiments are conceivable in which the diameter of the sleeve can also be 1 mm to 2 mm.

LIST OF REFERENCE SIGNS

[0038] 10 implant [0039] 11 wire structure [0040] 12 wire [0041] 13 distal end [0042] 14 proximal end [0043] 15 connection body [0044] 16 holding means [0045] 17 holding element [0046] 18 catheter [0047] 19 sleeve [0048] 20 first part [0049] 21 second part [0050] 22 passage [0051] 23 inner thread [0052] 24 outer thread [0053] 25 ring