Device for fixating a Kirschner wire
10842544 ยท 2020-11-24
Inventors
Cpc classification
A61B17/0642
HUMAN NECESSITIES
A61B2017/0641
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61B17/0643
HUMAN NECESSITIES
A61B17/84
HUMAN NECESSITIES
International classification
A61B17/84
HUMAN NECESSITIES
A61B17/86
HUMAN NECESSITIES
A61B17/04
HUMAN NECESSITIES
Abstract
The invention relates to a fixating device composed of plastic or metal for medical care, which fixating device interacts with a Kirschner wire (9) as a fastening means, comprising an opening for accommodating the fastening means and at least two further openings for accommodating fastening material in the form of stitches (13) and wires. The Kirschner wire (9) reaches through the one opening and is retained in the one opening in a positionally stable manner by the fastening material. The fixating device can be designed as a plate (101), be domed on all sides (1), or be designed as a sphere segment (211). The invention further relates to the use of the fixating device for osteosynthesis.
Claims
1. A fixating device and a fastener for use in surgery, the fixating device cooperating with the fastener and a fastening material, the fixating device comprising: at least one opening for receiving the fastener, the fastener reaching through the at least one opening and being retained in a positionally stable manner by the at least one opening and by the fastening material, wherein the at least one opening is a longitudinal hole, the longitudinal hole being a through-hole that extends through a top surface and a bottom surface of the fixating device, and the longitudinal hole having a major axis and a minor axis, and wherein a length of the at least one opening along the major axis is smaller than a maximum width of a bent, U-shaped portion of the fastener, such that during insertion of the bent, U-shaped portion of the fastener through the at least one opening, the bent, U-shaped portion of the fastener will become wedged within the at least one opening.
2. The fixating device according to claim 1, wherein the fixating device is a planar plate, or is domed on all sides or is provisioned in the shape of a cap as a sphere segment.
3. The fixating device according to claim 1, wherein the fixating device comprises, in addition to the at least one opening, at least two further openings for receiving the fastening material.
4. The fixating device according to claim 1, wherein the fixating device has an enlarged head region adjoined to a tapered region.
5. The fixating device according to claim 4, wherein the longitudinal hole extends from the enlarged head region into the tapered region.
6. The fixating device according to claim 5, further comprising four openings to receive the fastening material, wherein two of the four openings are provided in the enlarged head region on opposing sides of the longitudinal hole, and the other two of the four openings are provided in the tapered region.
7. The fixating device according to claim 6, wherein the other two of the four openings, that are provided in the tapered region, are positioned directly adjacent to each other.
8. The fixating device according to claim 1, wherein the longitudinal hole has at least two bulges, wherein the at least two bulges are regularly or irregularly molded on the longitudinal hole relative to one another.
9. The fixating device according to claim 1, wherein the fixating device is designed as a sphere segment, with indentations distributed on a periphery of an outer boundary of the sphere segment.
10. The fixating device according to claim 1, wherein the fixating device has an annular oval shape, with the longitudinal hole in an interior of the annular oval shape, wherein tunnel-like elevations are arranged on the annular oval shape opposing one another and cooperating with each other.
11. The fixating device according to claim 1, wherein the fastener is a Kirschner wire or a drill wire.
12. The fixating device according to claim 1, wherein the fastener is a Kirschner wire or a drill wire, wherein the minor axis of the longitudinal hole is made to accommodate a diameter of the Kirschner wire or the drill wire.
13. The fixating device according to claim 12, wherein the minor axis of the longitudinal hole corresponds to the diameter of the Kirschner wire or the drill wire, plus 0.05 mm to 1.0 mm.
14. The fixating device according to claim 13, wherein the fastening material is stitches or wires.
15. The fixating device according to claim 1, wherein the fixating device is made of plastic or metal, wherein the metal is selected from stainless steel or titanium.
16. The fixating device according to claim 1, wherein the fixating device is a planar plate, such that an entirety of the fixating device extends on a single plane.
17. The fixating device according to claim 1, wherein an entire perimeter of the longitudinal hole extends through the top surface and the bottom surface of the fixating device.
Description
(1) The invention will now be described in more detail by means of exemplary embodiments in conjunction with the appended drawings. The drawings show:
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EXEMPLARY EMBODIMENT I.1
(19) Fixating Device with all-Round Domed Design:
(20) A first embodiment of the fixating device according to the invention is shown in
(21) Correspondingly, the longitudinal and transverse diameters of the longitudinal hole 7 are aligned and matched to the thickness of the Kirschner wire 9 used. The longitudinal and transverse diameters of the longitudinal hole 7 can thus vary as a function of the strength of the Kirschner wire 9 to be used. In principle, the transverse diameter of the longitudinal hole 7 is designed such that it corresponds to the diameter of the Kirschner wire 9 used, plus at least 0.05 mm, preferably plus 0.1 mm, and maximally plus 1.0 mm.
(22) With respect to the diameter of the longitudinal hole 7 in its longitudinal direction, it is important that this longitudinal diameter is smaller than the maximum extent of the bent portion of the Kirschner wire 9 extending through the longitudinal hole 7 in this longitudinal direction.
(23) In this way, it is ensured that the Kirschner wire or drill wire 9 extends only partially through the longitudinal hole 7, as shown in
(24) The fact that the two limbs of the bent Kirschner wire or drill wire 9 are closer to one another in the region of the bending and thus are spaced apart from one another less than in the further course of the bending is hereby put to use.
(25) The fact that the Kirschner wire or drill wire 9 extends only partially through the longitudinal hole 7 and cannot slip through the longitudinal hole 7, but rather is retained in the latter, represents a fundamental feature of the fixating device according to the invention, which is also decisive for the following exemplary embodiments and their variants, even without this being explicitly mentioned again.
(26) For those skilled in the art, it is readily apparent from the illustrated purpose of the longitudinal hole 7 to receive the bent portion of the Kirschner wire 9, that the receptacle of the Kirschner wire 9 is not limited to the longitudinal hole 7 shown for the purpose of illustrating the invention. Instead of the longitudinal hole 7, the opening for the Kirschner wire 9 may, for example, also be ellipsoid, oval or rectangular in cross-section, and may include a combination of these shapes. This list is not intended to be exhaustive.
(27) In the exemplary embodiment described here, in each case adjacent to the two ends, in the longitudinal direction of the longitudinal hole 7, are two further openings designed as holes 11, which are circular. These are used to receive fastening material. Stitches and wires are to be mentioned in particular, among them polyethylene specialty yarns made from UHMWPE, commercially available from Arthrex, Inc. under the brand name FiberWire. Thus, for example, stitches 13 are introduced here and, with the inclusion of a cerclage wire 15 attached to the fracture, knotted between said wire and the bone, which is illustrated in
(28) The guidance of the cerclage wire 15 is also already apparent from
(29) The fixating device 1 is domed on all sides. In this case, the surface facing away from (distally located from bone or body) the imaginary bone or body which is to be fixated is convex, and the surface (proximate to bone or body) facing this bone or body is concave. Due to this all-round domed design, a significant improvement in the pressure conditions is achieved in the sense that the pressure for the overlying soft tissue is significantly reduced by an increase in the surface.
(30) Suitable material for the illustrated fixating device 1 is not only metal, here preferably titanium, but also plastic. All the edges of the respective openings of the fixating device, i.e. of the longitudinal hole 7 as well as of the additional circularly formed holes 11 are deburred in the exemplary embodiment. The same applies to the external edges of the fixating device.
(31) When Kirschner drill wire 9 alone is used, i.e., without the use of the cerclage 15, the fixating can be performed transosseously by means of a bone suture. The standalone wire or wires 9 are then secured to the bone or soft tissue with fastening material by means of the fixating device 1. The described fixating device 1 according to the invention can be used in so-called spike wire osteosynthesis. In this fixating method, which is referred to as pinning, as a rule two to three Kirschner wires 9 introduced through holes will bridge the fracture and serve for its stabilization. By means of the fixating device according to the invention, the Kirschner wires 9 are retained in a positionally stable manner.
(32) A further application for the described fixating device 1 according to the invention is tension band wiring, which is explained in the following with reference to
(33) For the application of the tension band wiring, the broken ends are brought together to a maximum and are first held by means of a clamp. In order not to allow the fracture gap indicated by the reference numeral 17 to be widened during stretching and to reduce shear forces, two Kirschner drill wires 9 are introduced parallel and longitudinally from one fragment through the fracture gap 17 to the other fragment, as close to the joint surface as possible. The aim is to also perforate the counter corticalis 19 and to leave the Kirschner drill wire 9 protruding less than 1 cm, which is indicated in
(34) In the case of such tension band wiring, the fixating device according to the invention can do without an additional attachment to the bone, the tendons or other soft tissue structures.
(35) In this application, it is also to be mentioned as an additional advantage of the above-described, overall domed configuration of the fixating device 1 according to the invention, that this results in a better covering of the tension band wiring at the point of intersection of the Kirschner wire 9 and the cerclage 15. The maximum load on the soft tissue lying above the bone fracture area is reduced by an increase in the surface.
EXEMPLARY EMBODIMENT I.2
(36) Fixating Device as Plate-Like Planar Design:
(37) As a second embodiment,
(38) The only difference to this variant of the fixating device 101 according to the invention is that it is not domed on all sides, but rather has a plate-like planar design. This has the advantage that the fixating device 101 can be adapted to the appropriate anatomical bone conditions by selecting in each case the convexity suitable for the appropriate medical treatment.
(39) The fixating device 101 according to this variant of the first exemplary embodiment is also designed to have an approximately flattened, mushroom-shaped configuration, and has an enlarged head region 103 and a consequent taper 105. An opening designed as a longitudinal hole 107 is provided approximately centrally, which extends in the longitudinal direction thereof in the direction of the taper 105 of the fixating device 101, and whose narrow sides are closed by half-circles whose diameter corresponds to the width of the longitudinal hole 107. This longitudinal hole 107 serves to receive the bent-over part of a fastening means in the form of a drill wire or Kirschner wire, which is not illustrated here again. Reference is therefore made to the further explanations for the first exemplary embodiment. These apply analogously here. With regard to the diameter of the longitudinal hole 107 in its longitudinal direction, it is also important here that this longitudinal diameter is smaller than the maximum extent of the bent portion of the Kirschner wire 109 extending through the longitudinal hole 107 in this longitudinal direction.
(40) In this variant of the first exemplary embodiment, in each case adjacently to the two ends in the longitudinal direction of the longitudinal hole 107, there are in each case two more openings designed as holes 111, which are formed circular. These serve to receive fastening material, as already explained.
(41) The guidance of the cerclage wire is already illustrated in
(42) In this variant of the fixating device 101 according to the invention of the first embodiment, the above-described advantages such as a significant improvement of the pressure conditions by reducing pressure on the overlying soft tissue, are also applicable. The maximum load of the soft tissue lying over the bone fracture region is reduced by an enlargement of the surface.
(43) Suitable material for the fixating device 101 shown here is metal, preferably titanium. All edges of the respective openings of the fixating device, i.e., of the longitudinal hole 107, as well as the other, circular holes 111, are deburred. The same applies to the external edges of the fixating device.
(44) The applications specified according to the first embodiment using only the Kirschner drill wire, without using the cerclage or the tension band wiring, are here just as possible, so that the configurations of the first embodiment II also apply and do not need to be repeated here.
(45) When using the tension band wiring, the inventive fixating device of this variant with the convexity adapted to the corresponding anatomical bone conditions does not need additional attachment to the bones, tendons or other soft tissue structures, and in this way, again achieves better coverage of the tension band wiring at the intersection of the Kirschner wire and the cerclage.
EXEMPLARY EMBODIMENT I.3
(46) Fixating Device as all-Round Domed Design or Plate-Like Planar Design with Reduced Hole Number
(47) The third embodiment of the fixating device according to the invention to be explained here is a variant of both the embodiment illustrated in I.1 as well as the variant described in I.2. This third embodiment is not further illustrated in the accompanying drawing.
(48) The modification of the fixating device according to this third exemplary embodiment is again flattened in the plan and is approximately mushroom-shaped and has an enlarged head region, followed by a tapering. Approximately centrally, this fixating device has an opening designed as a longitudinal hole which extends in its longitudinal direction in the direction of the tapering of the fixating device and whose narrow sides are closed by half-circles whose diameter corresponds to the width of the longitudinal hole. This longitudinal hole also serves again to receive the bent part of a fastening means in the form of a drill wire or Kirschner wire, reference being made to
(49) The only difference between this variant and the two previous embodiments of the fixating device according to the invention is that in each case adjacent to the two ends, in the longitudinal direction of the longitudinal hole, there are no two additional openings designed as circularly formed holes which are provided for the fastening material, but instead, overall only three openings designed as these circularly formed holes.
(50) These are arranged such on the fixating device that two of them are arranged at the end in the longitudinal direction of the longitudinal hole in the enlarged head region, while a single hole is provided at the end of the longitudinal hole in the region of the taper.
(51) This advantageously results in a reduction in the diameter of the fixating device according to the invention, transversely to the orientation of the longitudinal hole.
EXEMPLARY EMBODIMENT II
(52) Cap-Shaped Fixating Device as a Sphere Segment
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(54) This embodiment of the fixating device 201 according to the invention is a cap, the cross-section of which corresponds, as shown in
(55) Proceeding from this longitudinal hole 207 are further radiating indentations 227 for receiving the cerclage wire, which are formed on the sphere segment. In this embodiment of the fixating device 201 according to the invention, too, further holes for accommodating the fastening material are incorporated and are provided with the reference numeral 211.
(56) Suitable material for the illustrated fixating device 201, in addition to metal, here preferably titanium, is also plastic. All the edges of the respective openings of the fixating device, i.e., of the longitudinal hole 207 as well as the additional circular holes 211, are deburred in the exemplary embodiment. The same applies to the external edges of the fixating device.
EXEMPLARY EMBODIMENT III
(57) Fixating Device with all-Round Domed Design or Plate-Like Planar Design and Modified Longitudinal Hole
(58)
(59) This embodiment is shown in a two-dimensional view, as shown in
(60) These explanations are also intended to apply generally to the further embodiments to be explained hereinafter.
(61) The fixating device 301 according to this exemplary embodiment is designed approximately oval in plan, but can also be circular in plan.
(62) Arranged approximately centrally in this oval, the fixating device 301 has an opening designed as a modified longitudinal hole 307. This longitudinal hole 307 has a respective bulge 329, 329 on both sides along its longitudinal direction, which are irregularly molded relative to one another, in this exemplary embodiment. In this case too, the longitudinal hole 307 serves to receive the bent-over part of a fastening means in the form of a drill wire or Kirschner wire, not shown in detail in
(63) With reference to the first exemplary embodiment, it has been pointed out in I.1 that the longitudinal and transverse diameters of the longitudinal hole 307 are based on and matched to the strength or thickness of the Kirschner wire used. The longitudinal and transverse diameters of the longitudinal hole 307 thus vary depending on the strength of the Kirschner wire to be used. The transverse diameter of the longitudinal hole 307, which according to the first exemplary embodiment is designed such that it corresponds to the diameter of the Kirschner wire used plus at least 0.05 mm, preferably plus 0.1 mm, and at most plus 1.0 mm, is essential.
(64) With respect to the diameter of the longitudinal hole 307 in its longitudinal direction, it is important that this longitudinal diameter is configured smaller than the maximum extent of the bent part of the Kirschner wire projecting through the longitudinal hole 307 in this longitudinal direction.
(65) With the configuration of the longitudinal hole 307 according to the embodiment described here, a greater degree of freedom is achieved in the medical treatment of a bone fracture. Because the bulges 329, 329 are formed on both sides along the longitudinal direction of the longitudinal hole 307, and particularly because they are irregularly molded and oriented relative to one another, the fixating device 301 provides a recess for the cerclage wire in the sense that the fixating device 301 is better able to mold to the corresponding bone fracture during medical treatment and does not protrude through the guide of the cerclage wire coming from below.
(66) In each case, two further openings are provided designed as holes 311, each of which is circular in shape, adjacent to the bulges 329, 329 or to the two ends oriented in the longitudinal direction of the longitudinal hole 307. These are used to receive fastening material. This has already been explained further above under I.1 with regard to the first exemplary embodiment.
(67) The fixating device 301 is bent or domed on all sides. If appropriate, proceeding from the plate-like planar design, it is adapted to the corresponding anatomical bone conditions by selecting the suitable convexity appropriate for medical treatment. In this case, the surface (distal to the body) facing away from the imaginary body which is to be fixated is convex, and the surface (proximate to the body) facing this body is concave. The advantages of this curvature have already been pointed out.
(68) Suitable material for the illustrated fixating device 301 in the bent or all-round domed configuration is metal, here preferably titanium, and plastic. In the case of the initially plate-like planar design, which is then matched to the corresponding anatomical bone conditions by selecting the suitable convexity appropriate for medical treatment, metal and plastic are also suitable as material.
(69) All the edges of the respective openings of the fixating device 301, i.e., of the longitudinal hole 307, of the bulges 329, 329 as well as of the additional circularly shaped holes 311, are deburred in the exemplary embodiment. The same applies to the external edges of the fixating device.
(70) As with all previous embodiments of the fixating device according to the invention, this embodiment can also be used with the sole application of one or more Kirschner drill wires and in connection with cerclage in the case of tensioning. By means of the fixating device according to the invention, the Kirschner wires are retained in a positionally stable manner.
EXEMPLARY EMBODIMENT IV.1-IV.3
(71) Fixating Device in all-Round Domed Design or Plate-Like Planar Design with Modified Longitudinal Hole as the Sole Opening
(72)
(73) All representations of
(74) The fixating device 401 according to the variants of this exemplary embodiment shown in
(75) The fixating device 401 according to the variant shown in
(76) In the case of the fixating device 401 according to the variant shown in
(77) In the case of the fixating device 401 according to the variant of this exemplary embodiment illustrated in
(78) In contrast to the embodiments described thus far, in the case of the three variants, as illustrated in
(79) As a result, these embodiments distinguish themselves for use in small or smaller bones and represent variants which also enable simplified manufacture.
(80) All the variants described are either domed on all sides or arched from the outset, or have a plate-like planar design, which can again be adapted to the corresponding anatomical bone conditions by selecting the suitable convexity appropriate for medical treatment.
(81) In this case, the surface (distal to the body) facing away from the imaginary body to be fixated is convex, and the surface (proximate to the body) facing this body is concave. The advantages of this curvature have already been pointed out.
(82) Suitable materials for these variants of the fixating device 401 according to the invention in the case of the different embodiments mentioned are metal, in this case preferably titanium, and plastic.
(83) All the edges of the respective openings of the fixating device 401, i.e. of the longitudinal hole 407 and of the bulges 429, 429 are deburred in the exemplary embodiment. The same applies to the external edges of the fixating device.
(84) As with all previous embodiments of the fixating device according to the invention, this embodiment can also be used with the sole application of one or more Kirschner drill wires in connection with the cerclage in the case of tensioning. By means of the fixating device according to the invention, the Kirschner wires are retained in a positionally stable manner.
EXEMPLARY EMBODIMENTS V.1 AND V.2
(85) Fixating Device in All-Round Domed Design or Plate-Like Planar Design, Designed as an Annular Oval
(86)
(87) The representations of
(88) In the case of these two variants of fixating devices 501 as shown in
(89) The fixating device 501 according to the variants shown in
(90) In the variants shown in
(91) The fastening material in the form of stitches or wires can now be passed through the above-mentioned tunnel-like elevations 533 without shearing them off. The mutually corresponding tunnel-like elevations 533 allow for the fixating device 501 to better mold to the corresponding bone fracture during medical treatment and to not protrude through the guide of the cerclage wire coming from below.
(92) Suitable materials for these variants of the fixating device 501 according to the invention in the case of the different embodiments described are metal, in this case preferably titanium, and plastic.
(93) All the edges of the respective openings of the fixating device 501, i.e. of the longitudinal hole 507 and the tunnel-like elevations 533, are deburred in the exemplary embodiment. The same applies to the outer edges of the fixating device 501.
(94) As with all previous embodiments of the fixating device according to the invention, this embodiment can also be used with the sole application of one or more Kirschner drill wires and in connection with the cerclage in the case of tensioning. By means of the fixating device according to the invention, the Kirschner wires are retained in a positionally stable manner.
EXEMPLARY EMBODIMENTS VI.1-VI.4
(95) Fixating Device in All-Round Domed Design or Plate-Like Planar Design with a Single Opening and in Reduced Form
(96)
(97) In the illustrated variants of
(98) The fixating device 601 according to the variant of this exemplary embodiment shown in
(99) The fixating device 601 according to the variant of this exemplary embodiment shown in
(100) In these variants too, the longitudinal hole 607 receives the bent-over part of a fastening means in the form of a drill wire or Kirschner wire which is not shown in more detail in
(101) These embodiment variants are for use with small or smaller bones and are manufactured of metal, here preferably titanium, and plastic. All the edges of the respective openings of the fixating device 601 are deburred. The same applies to the external edges of the fixating device 601.