MEDICAL EXPANSION SYSTEM FOR EXPANDING A LONG BONE, AND KIT

Abstract

The present invention relates to a medical expansion system (100) for the expansion of a bone (200), in particular for the expansion of a tubular bone, comprising an expansion unit (1) extending in a longitudinal direction (L) with a first end (EE1) and a second end (EE2), wherein the expansion direction of the expansion unit (1) is aligned optionally substantially radially (R); a connecting catheter (3) which is connected, with a first end (EV1) thereof, to a first end (EE1) of the expansion unit (1); and a port (5) which is connected with a second end (EV2) of the connecting catheter (3); wherein the expansion unit (1), the connecting catheter (3) and the port (5) are in fluid communication with each other and the expansion system (100) is fluid-tight to the outside.

Claims

1. A medical expansion system for expanding a tubular bone, comprising an expansion unit extending in a longitudinal direction with a first end and a second end, wherein the expansion direction of the expansion unit (1) is aligned substantially radially; a connecting catheter connected with a first end thereof to a first end of the expansion unit; and a port connected to a second end of the connecting catheter; wherein the expansion unit, the connecting catheter and the port are in fluid communication with each other and the medical expansion system is fluid-tight to the outside.

2. The medical expansion system according to claim 1, wherein the first end of the connection catheter and the first end of the expansion unit are releasably connected to each other by a first connector.

3. The medical expansion system according to claim 1, wherein a second end of the connection catheter and the port are releasably connected to each other by a second connector.

4. The medical expansion system according to claim 1, wherein the port comprises a membrane for puncturing the port for supplying or withdrawing a fluid.

5. The medical expansion system according to claim 4, wherein the membrane comprises a membrane structure for being pierced with a cannula.

6. The medical expansion system according to claim 1, wherein the expansion unit is, or comprises, a dilatation balloon.

7-11. (canceled)

12. The medical expansion system according to claim 1, wherein the expansion unit expands within a surrounding hose, tube, mesh, fabric or braid.

13. (canceled)

14. The medical expansion system according to claim 1, wherein the expansion unit comprises along its longitudinal axis several different diameters, cross-sections and/or lumina.

15. The medical expansion system according to claim 1, wherein the expansion unit combines several expansion units or dilatation balloons in parallel or in series for the expansion in the longitudinal or circumferential direction.

16-18. (canceled)

19. The medical expansion system according to claim 1, comprising an elastic sheath for at least partially surrounding the non-compliant or semi-compliant or compliantly manufactured expansion unit.

20-26. (canceled)

27. The medical expansion system according to claim 1, wherein for injecting liquid there is no connection made via a connector of an injection device, but the subcutaneously placed port is punctured with a cannula.

28. The medical expansion system according to claim 1, wherein the expansion unit and/or the connecting catheter comprises an axial, flexible/rigid support structure.

29. The medical expansion system according to claim 1, wherein the port is or comprises a pump, embodied to convey or inject volume into the expansion unit out of a volume reservoir at the instigation of a user or in an automated manner.

30. (canceled)

31. The medical expansion system according to claim 1, wherein one to ten or more fixation eyelets and/or X-ray markers are attached to the expansion unit and/or to the connecting catheter, hence enabling the fixation of the expansion unit and/or of the connecting catheter via sutures in order to avoid dislocation during the period of use and/or enable position control by X-ray imaging.

32. A kit comprising at least one medical expansion system according to claim 1; and at least one liquid, wherein the medical expansion system or the closed expansion unit is filled with said liquid.

33. The kit according to claim 32, further comprising an injection syringe, preferably with an injection needle for filling or further filling the medical expansion system or the expansion unit with a liquid.

34. The kit according to claim 32, further comprising a first X-ray marker at the first end or section of the expansion unit, and/or a second X-ray marker at the second end or region of the expansion unit.

35. A method for expanding a tubular bone, encompassing the steps of: providing an medical expansion system according to claim 1; advancing the first end or section of the expansion unit via an access into an opened interior of the bone.

36. The method according to claim 35, further encompassing at least one of the steps: opening the access to the interior of the bone; dilating the access using a dilatator; opening a bone window at the shaft of the bone by osteotomy; and/or connecting the interior with a protective sleeve.

37. The method according to claim 35, wherein stepwise expansion of the expansion unit by volume injection via port takes place after a latency phase of about 3 to 12 days during which bone callus tissue has formed between osteotomized bone of origin and loosened bone fragment, thus leading to callus distraction of the bone callus tissue.

Description

[0076] In the following, the present invention, in particular the medical expansion system, is described based on preferred embodiments. The present invention is nevertheless not limited to these embodiments. The following applies in the figures:

[0077] FIG. 1 shows the medical expansion system according to the present invention of an embodiment in perspective view;

[0078] FIG. 2 shows the kit according to the present invention of an embodiment in perspective view;

[0079] FIG. 3a-c show the expansion unit in various embodiments;

[0080] FIG. 4a-e show further embodiments of the expansion unit;

[0081] FIG. 5a,b show the connecting catheter in various embodiments;

[0082] FIG. 6a -c show a schematic course for applying the medical expansion system according to the present invention to a tubular;

[0083] FIG. 7a -g show schematically simplified the individual steps or phases of expansion of the tubular bone by the expansion system according to the present invention;

[0084] FIG. 8a -d show further details of the individual steps of FIG. 7;

[0085] FIG. 9a,b show the removal of a bone segment and the preparation of the bone for bone transplantation using the expansion system according to the present invention;

[0086] FIG. 10a-d show the steps following the steps of FIG. 9 for preparing the bone to be transplanted using the expansion system according to the present invention;

[0087] FIG. 11a,b show the steps of an osteotomy following the steps of FIG. 10 for preparing the bone to be transplanted using the expansion system according to the present invention;

[0088] FIG. 12a-d show further steps possible for preparing the bone to be transplanted and the use of the expansion system according to the present invention; and

[0089] FIG. 13a-c show the final bone transplantation of the transplant expanded with the aid of the expansion system according to the present invention.

[0090] FIG. 1 shows an exemplary embodiment of the medical expansion system 100 according to the present invention, partly from the side and partly in perspective view.

[0091] The medical expansion system 100, referred to herein and also hereinafter shortly as expansion system 100, comprises an expansion unit 1 extending in a longitudinal direction L and having a first end EE1 and a second end EE2. The expansion direction of the expansion unit 1 is aligned or directed substantially in the radial direction R.

[0092] Further, the expansion system 100 comprises a connecting catheter 3 connected by or with a first end EV1 thereof to the first end EE1 of the expansion unit 1. Die Verbindung kann mittels eines optionalen, ersten Konnektors 7 erfolgen, sie kann alternativ stoffschltissig erfolgen. The connection may be established by an optional, first connector 7, it may alternatively be established in a material-fit manner.

[0093] The expansion system 100 further comprises a port 5 connected to a second end EV2 of the connecting catheter 3. The connection may be established by an optional, second connector 9, it may alternatively be established in a material-fit manner.

[0094] The port 5 is provided here exemplarily with a membrane 11. It fluidically seals the fluid system of the expansion system 100 from the outside. In the embodiment shown here, the membrane 11 may be provided in order to be punctured, e.g. by a cannula 301, see FIG. 2. Fluid may be supplied to the sealed fluid system via the cannula 301 by a syringe 300 as also shown in FIG. 2.

[0095] FIG. 2 shows the kit 400 according to the present invention of an embodiment in perspective view.

[0096] The kit 400 optionally comprises in this embodiment an expansion system 100 according to the present invention, which is filled with a liquid, preferably a physiological saline solution, and a syringe 300 with a cannula 301 for, preferably stepwise, further filling of the expansion system 100 with liquid from the syringe 300.

[0097] The expansion unit 1, the connecting catheter 3 and the port 5 are in fluid communication with each other. The expansion system 100 is fluid-tight to the outside towards the environment U. In other words, the expansion system 100 is self-contained.

[0098] FIGS. 3a-c show the expansion unit 1 in various embodiments.

[0099] FIG. 3a shows the expansion unit 1 in an optional tubular embodiment, in which the outer diameter is constant over the length L. An optional internal concentric support structure 3d may advantageously increase the stability of the expansion unit 1 before and/or during implantation. Purely exemplarily, the concentric support structure 3d may be a wire, a rope, a rod, a fabric or similar.

[0100] FIG. 3b shows the expansion unit 1 in an optional embodiment widening in a trumpet shape towards an end section. This may be used advantageously, to particularly strongly expand or widen for example certain longitudinal sections of a tubular bone.

[0101] FIG. 3c shows the expansion unit 1 in an optional embodiment that expands in a trumpet shape toward both end sections.

[0102] FIG. 3d shows the expansion unit 1 in a further, optional embodiment. The widening or expansion optionally takes place in individual sections 1a or segments 1a along the entire longitudinal extent of the expansion unit 1. The segments 1a may be of uniform or different design, for example of different lengths, with different diameters, with different materials and/or of different structure. This may advantageously be applied for different bone structures and/or implantation sections with regard to the surrounding soft tissue structures and/or the course of the outer contour of the bone.

[0103] FIGS. 4a-e show further embodiments of the expansion unit 1.

[0104] FIG. 4a shows an optional expansion unit 1 in a multi-lumen embodiment. The lumina 1b arranged in parallel may be arranged uniformly or differently within an outer sheath (shell, jacket). Thus, the expansion of the bone may advantageously be done selectively in order to affect different bone sections and/or surrounding tissue structures differently. The illustration to the right of FIG. 4a shows in a schematically simplified manner how the expansion pressure of the individual lumina may affect the expansion unit 1.

[0105] FIG. 4b shows a further, optional expansion unit 1 in a multi-lumen embodiment, wherein the individual lumina 1c are arranged concentrically and/or in multiple layers. In the illustration to the right of FIG. 4b, the expansion of an osteotomized bone 200 is shown schematically simplified. A callus may form between the bone segments, in particular stepwise.

[0106] FIG. 4c shows an optional expansion unit 1 in a further embodiment, wherein the expansion here does not occur uniformly radially over the circumference. The selective radial expansion over the circumference is achieved by different structures of the expansion unit 1, as shown exemplarily in FIG. 4c. The corresponding selective expansion of the bone 200 is shown schematically simplified in the illustration to the right of FIG. 4c.

[0107] FIG. 4d shows the expansion unit 1 in a further optional embodiment, which corresponds essentially to the illustration of FIG. 3a. The optional core supporting the expansion unit 1, which itself does not expand, may be of rigid or flexible design.

[0108] FIG. 4e shows the expansion unit 1 in a further optional embodiment, wherein the supporting structures 3d are optionally additionally arranged in sections outside the core. The support structure 3d may comprise or consist of a fabric or mesh. The support structure 3d may be arranged concentrically around a core.

[0109] FIG. 5a,b show the connecting catheter 3 in various embodiments.

[0110] FIG. 5b shows the connecting catheter 3 with an optional end section A that renders possible a direct introduction of a liquid into the expansion system 100. Similar to an introduction using a separate port 5, the end section A may include for example a membrane 11 for being punctured by an injection needle 301. In this way, the connecting catheter 3 requires no connection to a port, or its end section A with the membrane 11 is the port.

[0111] FIG. 5a shows the connecting catheter 3 with a further, optional end section A, which may have for example a cylindrical, oval, rectangular or other shape.

[0112] FIGS. 6a-c show a schematic course for applying the medical expansion system 100 according to the present invention to a tubular bone 200 or an embodiment of the method according to the present invention.

[0113] FIG. 6a shows schematically simplified an expansion of a bone segment osteotomized on the longitudinal side. The direction of expansion is indicated by the arrow shown radially, perpendicular to the longitudinal direction. By a gradual expansion, callus may form between the bone segments which gradually move away from each other. This is shown by the individual, arc-shaped lines.

[0114] FIG. 6b shows schematically simplified an optional arrangement of the expansion system 100 in the section of the lower extremities of a human being. The expansion unit 1 is arranged in the fibula (calf bone) directly adjacent to the tibia (shin bone). The connecting catheter 3 connects the expansion unit 1 to a port 5, which is arranged in the section of the femur (thigh bone).

[0115] FIG. 6c shows schematically simplified, in the four individual illustrations from top to bottom, with the respective cross sections on the right, the stepwise expansion of the osteotomized tubular bone 200 by the expansion system 100 according to the present invention over time (from top to bottom).

[0116] FIG. 7a-g show schematically simplified the individual steps for expansion of the osteotomized tubular bone 200 using the expansion system 100 according to the present invention.

[0117] FIG. 8a-d show further details of the individual steps of FIGS. 7a-g.

[0118] FIG. 9a,b show the removal of a bone segment to be replaced by a transplanted bone transplant being prepared using the expansion system 100 according to the present invention. Until the bone transplant is sufficiently expanded by the expansion system 100, the section of the removed bone segment is temporarily aided or provided with a so-called spacer 13.

[0119] FIG. 10a-d show the steps following FIG. 9 for preparing the bone segment to be transplanted with the aid of the expansion system 100 according to the present invention.

[0120] FIG. 11a,b show the steps of an osteotomy following FIG. 10 for preparing the bone to be transplanted with the aid of the expansion system 100 according to the present invention.

[0121] FIG. 12a-d show the further steps to be performed in order to prepare the bone 200 to be transplanted and the insertion of the expansion system 100 according to the present invention.

[0122] FIG. 13a-c show the final bone transplantation of the transplant being expanded with the aid of the expansion system 100 according to the present invention.

[0123] The pages of figures following FIGS. 1 to 13c again show the subject-matters according to the present invention in exemplary embodiments. The subject-matters shown therein may by the present invention be combined with any other features disclosed herein in any combination.

LIST OF REFERENCE NUMERALS

[0124] 100 medical expansion system [0125] 200 bones [0126] 300 syringe [0127] 301 cannula [0128] 400 kit [0129] EE1 first end of the expansion unit [0130] EE2 second end of the expansion unit [0131] EV1 first end of the connecting catheter [0132] EV2 second end of the connecting catheter [0133] L longitudinal direction [0134] R radial [0135] U environment [0136] 1 expansion unit [0137] 1a section, segment of the expansion unit [0138] 1b parallel lumen of the expansion unit [0139] 1c concentric lumen of the expansion unit [0140] 3 connecting catheter [0141] 3d support structure [0142] 5 port [0143] 7 first connector [0144] 9 second connector [0145] 11 membrane [0146] 13 spacer