Abstract
Snoring and sleep apnea are conditions associated with a narrowing of the airway. A device (10) and a method for piercing a soft tissue channel in the pharynx and an implant for insertion into this soft tissue channel are disclosed, with which these symptoms can be treated. The device according to the invention comprises a handle (12) and a blade (11) with a tip (16), which are connected to each other via an interface (13). In this process, a channel is pierced through the device (10), the shape of which is designed in connection with the shape of the implant in such a way that the narrowing of the airways is optimally treated.
Claims
1.-14. (canceled)
15. A device for piercing a soft tissue channel in a body part, comprising a blade, wherein the shape, size and material of the blade are selected in such a way that the blade deforms when the soft tissue channel is pierced, in such a way that the blade forms a soft tissue channel which is not straight and the shape and geometry of which does not substantially correspond to the shape of the blade in the undeformed state.
16. The device according to claim 15, wherein the blade is formed such that the blade does not kink when piercing the soft tissue channel and the blade is deformed into a shape that forms the soft tissue channel due to the structure of the soft tissue channel.
17. The device according to claim 15, wherein the blade is connected or connectable to a handle via an interface.
18. The device according to claim 17, wherein the blade is integrally formed with the handle.
19. The device according to claim 15, wherein the blade is made of a material having a bending strain of 0.4 to 20%.
20. The device according to claim 15, wherein a cross-sectional area of the blade measured in a plane perpendicular to a longitudinal axis is between 0.025 and 300 mm.sup.2.
21. The device according to claim 15, wherein the cross-sectional surface of the blade is convex and/or formed of straight boundary surfaces, wherein the convex boundary surfaces have a radius of curvature of 1 to 10,000 mm.
22. The device according to claim 15, wherein at least one surface of the blade is designed such that an implant can be displaced along the surface and the surface has an arithmetic average roughness Ra of 0.001 to 100 μm.
23. The device according to claim 15, wherein the blade has an stretched length of from 5 to 300 mm.
24. The device according to claim 20, wherein the blade is substantially partially curved along a longitudinal axis and the blade has a radius of curvature of from 1 to 10000 mm.
25. The device according to claim 15, wherein the blade is made of metal.
26. The device according to claim 17, wherein the blade has a tip on the opposite side of the handle and the tip has a cutting edge, wherein the cutting edge is formed over an angle of 10 to 80°.
27. An implant for insertion in a soft tissue canal in a body part, comprising a shaped piece, wherein the shaped piece is designed in such a way that the stability of the body part with the implant accommodated in the soft part canal is increased by an internal tension in the shaped piece compared to the stability of the body part without shaped piece.
28. A method for treating and for piercing a soft tissue channel in a body part, comprising the step: piercing a soft tissue channel with a device having a blade which deforms during the piercing wherein the blade forms a soft tissue channel whose shape and geometry does not substantially correspond to the shape of the blade in the undeformed state.
Description
[0037] The invention is explained in more detail below with reference to the figures and embodiment examples, showing:
[0038] FIG. 1a: the device for piercing a soft tissue channel in a body part from a laterally elevated perspective.
[0039] FIG. 1b: the device for piercing a soft tissue channel in a body part from a lateral perspective.
[0040] FIG. 2a: a blade for use as part of a device according to the invention.
[0041] FIG. 2b: the blade from FIG. 2a in a side view.
[0042] FIG. 3: a perspective view of the tip of the blade from FIG. 2a.
[0043] FIG. 4: a cross section of a blade of an embodiment according to the invention.
[0044] FIG. 5a: a top view of the tip of the blade according to FIG. 2a.
[0045] FIG. 5b: a side view of the tip of the blade of FIG. 5a.
[0046] FIG. 6a. a device according to the invention when piercing a soft part of a patient.
[0047] FIG. 6b: a device according to the invention in the deformed and undeformed state.
[0048] FIG. 6c: a device according to the invention with an implant.
[0049] FIGS. 7a-7e: show cross sections of alternative embodiments of a blade.
[0050] FIG. 1a shows a preferred embodiment of the device 10 according to the invention for piercing a soft tissue channel in a body part. This comprises a handle 12 to which a blade 11 is connected or connectable via an interface 13. The interface corresponds to a coupling such as is present in commercially available scalpels. On the opposite side of the handle 12, the blade 11 comprises a tip 16 with a cutting edge 17. The blade 11 in FIG. 1a is partially curved along the longitudinal axis L, which corresponds to a preferred embodiment of the device according to the invention. In the version shown here, it consists of spring steel 1.4310.
[0051] FIG. 1b shows essentially the same device as FIG. 1a, but from a different perspective. In particular, the curvature of the blade is better visible in this perspective.
[0052] In the device shown in FIGS. 1a and 1b, the handle 12 has a handle length GL of 152 mm, a handle height GH of 21 mm, a handle width GB of 7.5 mm, and a handle thickness GD of 2 mm. The blade 11 has a length KL of 79 mm and a height KH of 16 mm. When the blade 11 is inserted into the handle 12, the length ratio of handle 12 to blade 11 is 1:0.52.
[0053] FIG. 2a shows a blade 11 as it can be used in a device according to the invention. The blade comprises an interface 13 with which it can be reversibly fixed to a handle (not shown). In the present example, this is an interface such as is also present in commercially available scalpels. The tip 16 of the blade 11 comprises a cutting edge 17, which in the present example is semicircular and does not enclose a tip with an angle. It merges flush with the remaining part of the blade 11 and its surface 15. The surface 15 has, for example, a center roughness value of 10 μm. FIG. 2b shows essentially the same blade 11 as FIG. 2a in a side view.
[0054] FIG. 3 shows the tip 16 of the blade 11 in detail. The tip 16 is located on the opposite side of the handle with respect to the longitudinal axis L (not shown). The tip has a cutting edge 17 which is symmetrical to the longitudinal axis. However, it would also be conceivable to form the cutting edge asymmetrically with respect to the longitudinal axis L. Boundary surfaces 14 form the cross section of the blade 11. FIG. 4 shows a cross-section of the blade 11 in a plane perpendicular to the longitudinal axis L, designated P in FIG. 3, of the device 10 according to the invention. The boundary surfaces 14a, 14b, 14c, 14d of the blade in the embodiment shown here are straight and are at an angle 19a, 19b, 19c, 19d of 90° to each other. FIG. 5a shows the tip area of the blade 11 in a bird's eye view. The embodiment shown corresponds essentially to the embodiment shown in FIG. 2a and comprises a circular tip 16 with a cutting edge 17. Alternatively, however, pointed, elliptical or conical tips are also conceivable, each of which can be symmetrical or asymmetrical. FIG. 5b shows a side view of a tip region of the blade 11 of FIG. 5a. The cutting edge 17 also extends laterally over a portion of the blade 11. In particular, the blade 11 in the embodiment shown here comprises a point 16 with a ground angle α, which here is 60°. Symmetrical or asymmetrical designs as well as other angles are also possible.
[0055] FIGS. 6a-6c schematically show the sequence of a preferred method according to the invention. First, a device 10 according to the invention, which can be held by the operator via the handle 12, is pierced into a body part 50. The blade 11 deforms during the piercing, so that the shape of the channel 51 does essentially not correspond to the original shape of the blade. FIG. 6b shows a comparison of a device 10 implanted in the body part 50 of a patient (A) and a device 10 outside the body part in an undeformed state (B). The blade 11 of the device 10 was deformed during the piercing of the channel 51 (A) and has a smaller curvature compared to the device 10 outside the body part 50 (B).
[0056] FIG. 6c shows the insertion of an implant 30 comprising a shaped piece 31. This is pushed into the canal 51 along the surface 15 of the blade 11. The shape of the implant 30 was selected according to the patient's anatomy in order to achieve a desired return to the neutral position in the inserted state in the event of a deviation from the neutral position. FIG. 7a shows a cross-section, similar to that of FIG. 4, of a blade 11 in an alternative embodiment. The upper boundary surface 14a and the lower boundary surface 14c are straight and parallel to each other. The boundary surfaces 14b, 14d are also straight, but converge towards the upper boundary surface 14a. Thus the cross-section of the blade 11 as a whole forms a trapezoid. The angles 19a, 19b between the lateral boundary surfaces 14b, 14d and the upper boundary surface are obtuse, while the angles between the lateral boundary surfaces 14b, 14d and the upper boundary surface 14a are acute.
[0057] FIG. 7b shows a cross-section of a blade 11 in an alternative embodiment. The blade 11 is similar to that of FIG. 4, but the upper boundary surface 14a is convex, whereby the angles between this boundary surface 14a and the lateral boundary surfaces 14b, 14d are slightly greater than 90°. FIG. 7c shows a cross-section of an alternative embodiment of a blade 11. The lateral boundary surfaces 14b, 14d are straight and parallel. The upper boundary surface 14a is curved and convex in shape, while the lower boundary surface 14c is also curved but concave in shape. As a result, the cross-section as a whole has the shape of a curved band. Because the curvature of the lower boundary surface 14c is smaller than that of the upper boundary surface 14a, the thickness of the blade decreases toward the ends with the lateral boundary surfaces 14b, 14d. FIG. 7d shows a cross-section of another alternative embodiment of a blade 11. This blade is similar to the blade of FIG. 4. However, the lateral boundary surfaces 14b, 14d are connected to each other via rounded areas, so that the blade has angles 19c, 19d only at the lower boundary surface 14c. FIG. 7e shows a cross-section of a further alternative embodiment of a blade 11, which is similar to the blade of FIG. 7d. However, angled boundary surfaces are completely absent because the lower boundary surface 14c is also connected to the lateral boundary surfaces 14b, 14d via rounded areas.
