UTEROTUBAR IMPLANT DEVICE

Abstract

According to the invention, an uterotubal implant device is provided. Said uterotubal implant device comprises at least two compressible self-expanding bodies which are composed of a grid structure and are coupled to one another in a longitudinal direction such that one body is arranged distally in the longitudinal direction and the other body is arranged proximally in the longitudinal direction, at least one of the bodies having a spindle- or funnel-shaped design.

Claims

1. A uterotubal implant device comprising at least three compressible self-expandable bodies, the bodies being formed of a grid structure and coupled together in a longitudinal direction wherein a body at the distal end is a funnel-shaped body, which is formed to flare conically in the longitudinal direction from proximal to distal and a body at the proximal end is a funnel-shaped body, which is formed to flare conically in the longitudinal direction from distal to proximal and a further body disposed between the proximal and distal body is a spindle-shaped body which is formed as a body which in the longitudinal direction is so conically flared at its proximal end and tapered at its distal end such that the body forms a spindle shape.

2. The uterotubal implant device according to claim 1, wherein the bodies in the expanded state have different diameters, wherein the central body or bodies preferably have a smaller diameter in the expanded state than the proximal and the distal body.

3. (canceled)

4. The uterotubal implant device according to claim 1, wherein a connecting wire or connecting wire sections are provided, which extend through the bodies in the longitudinal direction, wherein the bodies are connected at least at their proximal and/or distal ends with the connecting wire or the connecting wire sections, such that the coupling of the bodies is effected by means of the connecting wire, wherein the connecting wire or the connecting wire sections is formed of one or more wires of metal or plastic in a strand or coil shape of metal or plastic.

5. The uterotubal implant device according to claim 1, wherein at the distal end of the distal body, a distal wire portion, or at the distal end of the connecting wire or a connecting wire section, a probe tip is provided, for example, formed as an atraumatic ball.

6. The uterotubal implant device according to claim 4, wherein one end of the spindle-shaped body, preferably the proximal end, is coupled by means of a sleeve to the connecting wire such that the proximal end of this body is longitudinally slidably connected to the connecting wire, and a distal end of the spindle-shaped body, preferably by means of a sleeve, is fixedly connected to the connecting wire.

7. The uterotubal implant device according to claim 1, wherein a portion of the bodies and/or a section of the connecting wire arranged between two bodies, over which the bodies are coupled together, referred to as a coupling section, wherein the coupling section is flexible in such a way, that the bodies can be adapted to an anatomical course of a fallopian tube.

8. The uterotubal implant device according to claim 1, wherein the device comprises two to four and in particular three bodies, wherein the device comprises in the longitudinal direction from distal to proximal a first body which is spindle-shaped and provided for implantation in the isthmic portion, a second body, which is spindle-shaped and is provided for implantation in the intramural portion and a proximal body, which is also spindle-shaped and is provided for implantation in the uterine cavity, or that the third, proximal and the middle, second body is spindle-shaped and the first, distal body is funnel-shaped, or that the middle, second and the distal, first body is spindle-shaped and the proximal, third body is funnel-shaped, or that the third, proximal and the first, distal body is funnel-shaped and the middle, second body is spindle-shaped, wherein the proximal body is formed from distally to proximally or from proximal to distal conically flared or that the distal body is formed from distal to proximal or from proximal to distal conically flared.

9. The uterotubal implant device according to claim 1, wherein the length of the device from the distal end of the distal body to the proximal end of the proximal body accounts for preferably 35 mm to 45 mm, and the diameter in the expanded state in about 1 mm to 4 mm.

10. The uterotubal implant device according to claim 1, wherein the bodies at least partially have a different diameter, and a body arrangeable in the uterine cavity or uterotubal junction is referred to as a distal body having a diameter of about 3 mm to 4 mm, and preferably in about 3 mm, and one or two bodies which are provided for implantation in the intramural portion and the body or bodies are referred to as the second and third body, wherein the body or bodies have a diameter of about 2 mm, and a body is provided for implantation in the isthmic portion, said body is referred to as a proximal body, wherein the proximal body has a diameter of about 3 to 4 mm.

11. The uterotubal implant device according to claim 1, wherein the proximal and distal bodies in the expanded state have a larger diameter and a greater radial expansion force than at least one intermediate body arranged therebetween.

12. The uterotubal implant device according to claim 1, wherein the bodies are braided from one or more wires or made of a tubular body by means of laser cutting, wherein the openings of the bodies has an opening width of less than 1 mm, in particular from 300 m up to 600 m.

13. The uterotubal implant device according to claim 1, wherein the bodies in the expanded state have a predetermined radial expansion force, large enough to expand the fallopian tube portion to form a contact portion of an outer wall of the bodies to the fallopian tube wall, wherein the contact portion contacts with the fallopian tube wall in such a way that a mechanical stimulus is generated such that at least a portion of the contact portion of the bodies undergoes ingrowth into the fallopian tube wall, and the corresponding grid structure contacts the fallopian tube portion in such an atraumatical way that the fallopian tube wall is not damaged.

14. The uterotubal implant device according to claim 1, wherein the outer surfaces of one or more bodies are completely or at least partially coated, wherein the coating may comprise one or more components, consisting of a polymer, for example polyurethane or a biodegradable polylactide or a swellable hydrogel, wherein, the coating in particular includes a hydrogel component and/or is doped with a bioactive agent and/or this drug is a spermicide, such as Nonoquinol-9, and/or an anti-progesterone, which reduces bleeding and promotes implant ingrowth.

15. The uterotubal implant device according to claim 1, wherein a spindle-shaped body is filled with a closure-promoting material, such as biocompatible textile fibers of polyethylene terephthalate, polyamide or biodegradable polylactide and/or wherein the fibers are preferably impregnated with hydrogel and/or that fibers such as copper threads, are woven or braided in the grid structure to increase the spermicidal effect.

Description

[0083] The invention will be explained in more detail below with reference to the drawings. These show in

[0084] FIG. 1 shows a uterotubal implant device according to the invention in a state introduced at the implantation site, in a fallopian tube respectively,

[0085] FIG. 2 shows a device according to the invention in a schematic side view,

[0086] FIG. 3 shows a further exemplary embodiment of the device according to the invention in a schematic side view,

[0087] FIG. 4 shows a further exemplary embodiment of the device according to the invention in a schematic side view,

[0088] FIG. 5 shows a further exemplary embodiment of the device according to the invention in a schematic side view,

[0089] FIG. 6 shows a further exemplary embodiment of the device according to the invention in a schematic side view,

[0090] FIG. 7 shows a detailed view of an end of a funnel-shaped body of the device according to the invention,

[0091] FIG. 8 shows a preferred embodiment of a uterotubal implant device according to the invention in a state introduced at the implantation site, in a fallopian tube respectively,

[0092] FIG. 9 shows a preferred embodiment of a braided device according to the invention in a schematic side view,

[0093] FIG. 10 shows a preferred embodiment of a laser-cut device according to the invention in a schematic side view,

[0094] FIG. 11 shows a further preferred embodiment of a device according to the invention in a schematic side view,

[0095] FIG. 12 shows a further preferred embodiment of a device according to the invention in a schematic side view, and

[0096] FIG. 13 shows a further preferred embodiment of a device according to the invention in a schematic side view.

[0097] A uterotubal implant device 1 according to the invention comprises at least two compressible self-expandable bodies 2, wherein the bodies are formed from a grid structure 3. The bodies 2 are coupled together in a longitudinal direction 4 such that one of the bodies 2 is arranged distally 5 in the longitudinal direction and the other body 2 is arranged proximally 6 in the longitudinal direction 4.

[0098] In the following, the uterotubal implant device 1 according to the invention will be described in more detail with reference to a first exemplary embodiment (FIGS. 1 and 2).

[0099] According to this first embodiment, the device 1 comprises in the longitudinal direction 4 from distal 5 to proximal 6 a first and a second body 7, 8, which are intended for implantation in the isthmic section, a third and a fourth body 9, 10 for implantation in the intramural section, and a proximal body 11 for implantation in the uterine cavity.

[0100] The bodies 2, 7, 8, 9, 10 and 11 are designed to be compressible and self-expandable. In this way, it is possible to implant the device 1 minimally invasively by means of a thin catheter (not shown). The catheter can be advanced hysteroscopically or under fluoroscopic control to the site of implantation.

[0101] The bodies 2, 7, 8, 9, 10 and 11 have a predetermined radial expansion force in the expanded state. This expansion force is large enough or dimensioned so that the bodies can slightly expand a fallopian tube section, which they contact, in order to effect full circumferential contact of the body with the fallopian tube wall. This contact acts as a mechanical stimulus for ingrowth of the bodies into the fallopian tube wall. In addition, the radial expansion force must be dimensioned such that a contact portion 12 (FIGS. 1, 2) of an outer wall of the body 13 contacts the Fallopian tube so that no chronic irritation, perceived as painful, or even penetration of the Fallopian tube occurs. That means, the expansion force must be such that the contact portion 12 of the outer wall 13 of the body atraumatically contacts with the corresponding portion of the Fallopian tube wall.

[0102] The bodies 2, 7, 8, 9, 10 and 11 are braided from a plurality of wires so as to form a braided tubular endless structure. This structure is cut to length corresponding to a total length of the device 1 of approximately 35 mm at the proximal and distal ends 5, 6.

[0103] At the proximal and distal ends 6, 5 and at four intermediate coupling sections 14, the bodies are constricted or compressed. The compression can be done for example by means of welding spots, gluing or a mounted sleeve.

[0104] According to the first embodiment, sleeves 19, 20, 21, 22, 23, 24 are provided. The areas in which the sleeves 20, 21, 22, 23 are arranged form coupling sections 14.

[0105] As a braided wire, a nitinol wire (shape-memory alloy) is preferably provided. The shaping during tempering of the shape-memory alloy can influence or set the radial expansion force. Furthermore, the radial expansion force can be influenced by the type of grid structure 3 or the wire mesh of the bodies, the number of wires, the diameter of the wires and the bodies and the braid angle of the wires. It is a braid angle of preferably greater than 35 provided with respect to an axial center axis, in order to achieve a sufficient self-expandability.

[0106] The grid openings formed in the grid structure 3 of the bodies preferably have a maximum width or a strut spacing of less than 1 mm, or from 200 m to 700 m, in particular from 300 m to 600 m.

[0107] At the distal end 5 of the implant 1, a probe tip 17 is arranged. The probe tip 17 preferably includes a wire portion 26 and an atraumatic ball 18 disposed thereon.

[0108] The struts or braided wires that form the outer surfaces of the bodies are preferably completely or at least partially coated. The coating (not shown) may comprise a polymer, such as e.g. a polyurethane or a biodegradable polylactide or a swellable hydrogel. The coating can in principle be formed from all plastics in which drugs can be stored and which release an active substance over a longer period of time.

[0109] Furthermore, the coating can, in particular if a swellable hydrogel is provided, be doped with a bioactive agent. The active ingredient may be, for example, a spermicide, such as Nonoxinol-9. Furthermore, such an active ingredient can be an anti-progesterone, which reduces the tendency to bleed and promotes or supports the ingrowth of the implant into the fallopian tube wall.

[0110] The spindle-shaped bodies 2, 7, 8, 9, 10 and 11 according to the first exemplary embodiment are additionally or alternatively to their coating filled with a closure-promoting material (not shown). For example, biocompatible textile fibers of polyethylene terephthalate, polyamide or biodegradable polylactide are provided as closure-promoting material. By a swellability of such fibers in contact with liquid, the closure effect is promoted. The fibers may also be hydrogel impregnated to increase swellability.

[0111] Additionally and/or alternatively, the grid structures of the bodies are directly coated with swellable hydrogel. Both the fibers and/or the hydrogel may be doped with a bioactive agent.

[0112] Biodegradation of polylactide produces acid degradation products. In such an acidic environment sperm motility is considerably reduced. In this way, the contraceptive effect can be increased.

[0113] Additionally and/or alternatively, in order to increase the spermicidal effects, threads may be introduced into the grid structure of the implant bodies by means of weaving or braiding. Here, in particular, copper or polylactide fibers are provided.

[0114] Additionally and/or alternatively, swelling polymer fibers can be woven or interwoven into the grid structure to increase the closure effect. It is also possible that the filling described above contains copper in order to increase the spermicidal effect, or contains gold or silver to exert a bactericidal effect.

[0115] The length of the device according to the invention from a distal end of the first body 7 to a proximal end of the fifth body 11 is 10 mm to 70 mm or 20 mm to 60 mm and preferably 35 mm to 45 mm.

[0116] The bodies are preferably rotationally symmetrical.

[0117] Furthermore, the bodies may have different lengths.

[0118] According to the first exemplary embodiment, the fifth body 11 which can be arranged in the uterine cavity has a diameter of approximately 3 to 4 mm, and the third and fourth bodies 9, 10 have a diameter of approximately 2 mm in the expanded state, which are provided for implantation in the intramural portion, and the first and the second body 7, 8, which are provided for implantation in the isthmic section, have a diameter of about 3 mm in the expanded state. The tolerance of the expanded bodies is approximately +/1 mm.

[0119] According to an alternative embodiment of the first embodiment (not shown), a connecting wire 16 may also be provided which extends through the bodies in the longitudinal direction 4.

[0120] According to this first embodiment, the connecting wire 16 is a single, continuous wire made of metal or plastic. Alternative embodiments of the connecting wire will be described in more detail below. In the case that the connecting wire 16 is formed of plastic, this may for example be made of a biodegradable polylactide.

[0121] The bodies 2, 7, 8, 9, 10 and 11 are connected to the connecting wire only at the distal end via a distal sleeve 19. The distal sleeve 19 is fixedly connected to the connecting wire 16.

[0122] The remaining sleeves 20, 21, 22, 23 and 24 arranged between the bodies are coupled to the connecting wire such that all distal and proximal ends of the body or the corresponding sleeves 20 to 24 except for the fixedly connected to the connecting wire distal sleeve 19 are slidably connected to the connecting wire in the longitudinal direction.

[0123] The connecting wire 16 can also contain copper and/or gold and/or silver or be coated with copper and/or gold and/or silver.

[0124] In the following, a second embodiment (FIG. 3) of the present invention will be explained.

[0125] Unless otherwise described, this embodiment corresponds to the first embodiment and includes all features of the first embodiment. Identical parts are provided with the same reference numerals.

[0126] According to the second embodiment, only four spindle-shaped bodies are provided instead of five spindle-shaped bodies. In this case, the fourth body was dispensed with, so that the fifth body is arranged immediately after the third body. Here, the fifth body has a greater length in the longitudinal direction than in the first embodiment.

[0127] In the following, a third embodiment (FIG. 4) of the device according to the invention will be described. Unless otherwise described, the third embodiment includes the same features as the first embodiment. Identical parts are provided with the same reference numerals.

[0128] According to the third embodiment, the proximal and the fifth body 11 is not spindle-shaped, but funnel-shaped or, in particular, bell-shaped.

[0129] It is provided that a distal end 5 of the fifth body 11 is coupled by means of a sleeve with a proximal end of the fourth body 10.

[0130] A fourth embodiment of the present invention will now be described (FIG. 5). Unless otherwise described, this embodiment corresponds to the third embodiment and has the same features. Identical parts are provided with the same reference numerals.

[0131] In the fourth embodiment, the second body 8 is not spindle-shaped, but bell-shaped. It is provided that the distal sleeve 20 which is arranged at the distal end of the first bell-shaped body 8, is fixedly connected to a connecting wire section 25. The connecting wire portion 25 is fixedly connected to the distal sleeve 21 of the spindle-shaped body 9.

[0132] The second bell-shaped body 8 is thus not directly connected to the third body 9 according to this embodiment. The coupling of the two distal bodies 7 and 8 with the three proximal bodies 9, 10, 11 takes place via the connection wire section 25.

[0133] The third and the fourth body 9, 10 are again formed spindle-shaped and the fifth body 11 is bell-shaped as described in the third embodiment. It is provided that the fourth body 10 is connected via a proximal sleeve 23 with a distal end of the bell-shaped body 11.

[0134] The device according to the invention will be described below with reference to a fifth exemplary embodiment (FIG. 6). Unless otherwise described, this device corresponds to the device described above, in particular it is similar to the fourth embodiment. Identical parts are provided with the same reference numerals.

[0135] According to the fifth embodiment, it is provided that all five bodies are individually or separately connected to a continuous connecting wire 16. This means, the first distal body 7 is spindle-shaped and is connected to a distal stationary sleeve and a proximal slidable sleeve to the connecting wire.

[0136] The distal end of the bell-shaped second body 8 is fixedly connected to the connecting wire 16 at its proximal end with a proximal sleeve. The third body is fixedly connected at its proximal end to the connecting wire 16 and the proximal sleeve of the third body 9 is slidably connected to the connecting wire. The same applies to the fourth body 10.

[0137] The fifth, bell-shaped body 11 is connected according to the second body 8 with the connecting wire.

[0138] A first preferred embodiment of the uterotubal implant device 1 according to the invention comprises three compressible self-expandable bodies 2, which are formed from a braided grid structure 3. Unless otherwise described, the preferred embodiment may include all the features of the embodiments discussed above (FIGS. 8 and 9).

[0139] The bodies 2 are coupled to one another in a longitudinal direction 4 such that one of the bodies 2 is arranged distally 5 in the longitudinal direction, the other body 2 proximally 6 in the longitudinal direction 4 and the third body approximately midway between the two.

[0140] According to this preferred embodiment, the device 1 comprises in the longitudinal direction 4 from distal 5 to proximal 6 a first body 7 which is spindle-shaped and is intended for implantation in the isthmic section, a second body 8 which is spindle-shaped and is provided for implantation in the intramural section and a proximal body 9, which is also formed spindle-shaped and is intended for implantation in the uterine cavity.

[0141] The bodies 7, 8 and 9 have a predetermined radial expansion force in the expanded state. This expansion force is large enough or dimensioned such that the bodies can slightly expand a fallopian tube section which they contact, in order to bring about full circumferential contact of the bodies with the fallopian tube wall. This contact acts as a mechanical stimulus for body ingrowth into the fallopian tube wall. In addition, the radial expansion force must be dimensioned such that a contact portion 12 (FIG. 8) of an outer wall of the body 13 contacts the fallopian tube such that no chronic irritation, which is felt to be painful, or even penetration of the fallopian tube wall occurs. That means, the expansion force must be adjusted such that the contact portion 12 of the outer wall 13 of the bodies contact atraumatically with the corresponding portion of the Fallopian tube wall.

[0142] The bodies 7, 8 and 9 are braided from a plurality of wires so as to form a braided tubular endless structure. This structure is cut to length corresponding to a total length of the device 1 of approximately 35 mm to 45 mm at the proximal and distal ends 5, 6.

[0143] The bodies 7, 8 and 9 have a diameter of approximately 1 to 3 mm in the expanded state in the regions of their greatest extent transverse to the longitudinal direction of the device. In particular, the first distal body 7 and the third proximal body 9 have a larger diameter than the middle body 8, wherein preferably the proximal body 9 has a larger diameter than the distal body 7.

[0144] FIG. 10 shows such a device whose grid structure has been produced by means of laser cutting. The spindle-shaped bodies also have a spindle shape in the laser-cut state. However, these include grid-related steps. These steps have a mechanical fixation effect in the fallopian tube, so that in laser-cut production, the use of funnel-shaped bodies is not absolutely necessary to achieve a fixation effect.

[0145] According to the preferred embodiment described above, the device according to the invention comprises three bodies, all three bodies being spindle-shaped (FIGS. 8, 9 and 10).

[0146] According to an alternative preferred exemplary embodiment, wherein the arrangement of the bodies in the fallopian tube corresponds to the exemplary embodiment explained with reference to FIGS. 8 and 9, the third proximal and middle second bodies 8, 9 are spindle-shaped and the first distal body 7 is funnel-shaped (FIG. 11). Preferably, the proximal, first body 9 has a larger diameter than the distal body 7, and the distal first body 7 has a larger diameter than the middle second body 8.

[0147] Alternatively, the middle second and distal bodies 8, 7 may be spindle-shaped and the proximal third body 9 may be funnel-shaped (FIG. 12).

[0148] Furthermore, it can also be provided that the third proximal and first distal bodies 9, 7 are funnel-shaped and the middle second body 8 is spindle-shaped. The proximal body may then be conically widening from distal to proximal or from proximal to distal. The distal body may then be conically widening from distal to proximal or from proximal to distal. However, it is preferred that according to such a design of the device, the proximal body from distally to the proximal and the distal body from proximal to distal are conically widening (FIG. 13). According to such a design of the device, the distal first and the proximal third funnel-shaped bodies are referred to as locking funnels.

[0149] In the following, alternatives and details of the device according to the invention will be described.

[0150] FIG. 7 is a detail view of one end of a funnel-shaped body of the device according to the invention. Here it is provided that the proximal ends are formed into loops and therefore less traumatic.

[0151] The bodies according to the first and second embodiments are formed from a tubular endless structure, wherein the coupling sections are made by radial compression. The constrictions can be done by welding spots, gluing or just the sleeves described above.

[0152] It is then provided that only one probe tip is provided with an atraumatic ball at a distal end of the distal body.

[0153] A section between two bodies and/or a section of the connecting wire, which is arranged between two bodies and via which the bodies are coupled to one another, is referred to as a coupling section, wherein the coupling section is designed so flexibly that the bodies can be adapted to an anatomical course of a fallopian tube.

[0154] According to an alternative embodiment, the bodies may be braided from a single wire.

[0155] According to a further alternative, the bodies may be manufactured from a tubular body by means of laser cutting. In laser cutting, the radial expansion force can be adjusted by the following parameters: by the cutting pattern of the laser cut grid and by diameter, thickness and material of the tube semi-finished product and its shaping during tempering, wherein preferably a shape memory alloy such as Nitinol is applied.

[0156] Alternatively, the connecting wire 16 can also be made of a plurality of wires and thus strand-shaped or of a plurality of wires twisted together and thus shaped like a spiral coil. According to another embodiment, the connecting wire 16 may comprise an outer spiral coil wire comprising a central wire. This central wire forms a core to absorb the tensile forces acting on the connecting wire.

[0157] In providing a connecting wire, the bodies must be sufficiently spaced apart from each other, or, respectively, their distal and proximal sleeves must be sufficiently spaced apart from each other, to make the shortening on expansion such that they do not contact each other.

[0158] In all the embodiments described above, a proximal ejection wire section 27 may be provided, however, which does not take over a connection function between the bodies, but serves for better ejectability of the compressed implant arranged in a catheter.

[0159] Basically, the device or bodies must be designed such that after the device has been placed in the fallopian tube at the site of implantation and the catheter used for insertion is retracted, the bodies have sufficient freedom of movement in the longitudinal direction to take their fully expanded state.

[0160] As an alternative to self-expansion, the multiple bodies can be expanded sequentially or simultaneously by means of one or more balloon catheters.

[0161] FIG. 10 shows a perspective view of a cutting pattern of a connecting region of two bodies of the device according to the invention, produced by means of laser cutting, in a side view.

[0162] In case of producing the bodies by laser cutting in the diameter-changing intersections steps can be formed by the grid structure of the bodies due to radial deployment, e.g. at the proximal and distal end of a body and/or in the area between. Such steps are advantageous in that they exert an anchorage and fixation in contact with the fallopian tube wall against dislocation in the fallopian tube.

LIST OF REFERENCES

[0163] 1 uterotubal implant device [0164] 2 body [0165] 3 grid structure [0166] 4 longitudinal direction [0167] 5 distally [0168] 6 proximally [0169] 7 first body [0170] 8 second body [0171] 9 third body [0172] 10 fourth body [0173] 11 fifth body [0174] 12 contact portion [0175] 13 outer wall [0176] 14 coupling section [0177] 15 sleeve [0178] 16 connecting wire [0179] 17 probe tip [0180] 18 atraumatic sphere [0181] 19 distal sleeve [0182] 20 sleeve [0183] 21 sleeve [0184] 22 sleeve [0185] 23 sleeve [0186] 24 sleeve [0187] 25 connecting wire section [0188] 26 distal wire section [0189] 27 proximal ejection wire section