TWM509626U - Osteotomy implant - Google Patents

Abstract

The present inventions relates to an osteotomy implant (10; 10.1, 10.2, 10.3, 10.4) for bridging an osteotomy opening or resection (41) in a target bone in a substantially countersunk manner. The osteotomy implant (10; 10.1, 10.2, 10.3, 10.4) comprises a proximal portion (11) with at least one aperture (14, 15) for receiving at least one bone screw (50a, 50b) and a distal portion (20) with at least one aperture (23, 24) for receiving at least one bone screw (50c, 50d). At least one middle strut portion (30) connects said proximal portion (11) with said distal portion (20). Said at least one middle strut portion (30) has a width (W) which is equal to or smaller than a thickness (T) of said at least one middle strut portion (30).

Description

Osteotomy

This creation relates to a surgical device for performing an open wedge osteotomy and a closing wedge osteotomy of the knee.

Knee osteotomy is a surgical procedure used to realign the Mikulicz-line of the large joints of the lower extremities (ie, hips, knees, and ankles). In the case of normal axial alignment of the limb, the center of the hip, the intercondylar ridge of the tibial plateau, and the center of the ankle joint are in a line that is the mechanical axis of the lower extremity.

This alignment can be disturbed by, for example, arthritic damage, congenital dislocation, or traumatic injury on one side of the knee, and causes excessive wear of knee cartilage known as knee-arthroses.

The purpose of the knee osteotomy technique is to re-divide the force in the knee away from the damaged area to the relatively healthy side of the knee in the early stages. The force and muscle reaction originating from the patient's weight are better spread throughout the knee joint.

Two techniques are common in clinical practice, namely open wedge osteotomy and closed wedge osteotomy. Both techniques are intended to partially or completely re-establish the aforementioned Miguriz line.

Remove the bone below the tibial plateau when performing the closed wedge technique Head wedge. The tibial plate is pulled down to close the gap and secured with a traumatic plate and screws.

When the open wedge technique is performed, a horizontal bone incision is made throughout the tibial plateau over approximately 80% of the surface area. Insert a wedge-shaped spacer. The tibial plateau is forced upward on one side to correct the leg axis. The wedge-shaped septum can be made of natural bone, artificial bone or other biocompatible or osteointegrative material.

In order to hold the septum in place, the septum is usually secured with a traumatic plate and screws.

Knee osteotomy surgical techniques provide important benefits to patients because knee osteotomy techniques can delay the time a patient needs to perform an overall knee replacement for up to 10 years.

Despite these advantages, complications are often associated with this technique, which often causes the patient to be uncomfortable during recovery. One of the more important causes of pain is the protrusion of the plate and the screw on the top of the bone, causing soft tissue irritation.

US 8,137,406 B2 (Arthrex Inc.) discloses a device for performing an open wedge high tibial osteotomy of the knee. The device includes an osteotomy plate including a body having a front side and a back side, a protrusion extending from a back side of the body for mounting in a wedge opening such as a bone, and for receiving A plurality of mounting holes for fixing screws. The mounting holes are formed such that when the protrusions are positioned in the wedge-like opening, the set screws are guided into the bone on either side of the wedge-like opening.

A major drawback of the device disclosed in U.S. Patent No. 8,137,406 B2 is that the osteotomy plate spans a large section of a wedge opening such as a bone, thereby preventing bone ingrowth throughout the large segment. In addition, the bone plate has a shape that follows the contour of the patient's bone at the edge of the wedge-like opening, whereby the shape of the bone plate does not open The protuberance of the bone plate over the edge of the opening is caused by the exact alignment of the outer contour.

The purpose of this creation is to create an osteotomy implant in the first-mentioned technical field that only insignificantly interferes with bone ingrowth in the osteotomy opening and reduces the bulge of any implant portion. The occurrence of convexity.

The solution for this creation is specified by the characteristics of item 1 of the scope of the patent application. According to the present invention, an osteotomy implant bridging an opening in a target bone in a substantially countersunk manner comprises: a proximal end having at least one aperture for receiving at least one bone fixation element; and a distal end An end having at least one aperture for receiving at least one bone fixation element. Additionally, the osteotomy implant includes at least one intermediate post connecting the proximal portion and the distal portion. The at least one intermediate post portion has a width equal to or less than a thickness of one of the at least one intermediate post portion.

Providing the at least one intermediate strut portion having the width-to-thickness ratio described has the advantage of providing sufficient support throughout the osteotomy opening by the at least one intermediate strut portion while reducing the protuberance due to the at least one strut portion Soft tissue stimulation. This situation is primarily due to the fact that the at least one intermediate strut is buried in the target bone. In addition, because the width of the at least one intermediate strut portion can be kept relatively small; the ingrowth of the bone into the open wedge is only negligibly disturbed. Additionally, only a small portion of the edge of the osteotomy opening is occupied by the osteotomy implant, thus allowing a larger portion of the edge to be occupied or remain open by, for example, bone replacement material. The bone replacement material will gradually be absorbed and replaced by natural bone. If the osteotomy opening is left open, the natural bone will gradually grow into the opening and close the gap.

In the present application, the term "buried head" means that the respective portions of the osteotomy implant are completely placed into the target bone, the surface of the osteotomy implant being flush with the surface of the target bone.

Additionally, the width of the at least one intermediate post portion is defined by the size of the surface that is placed substantially parallel to the edge of the osteotomy opening in a direction substantially perpendicular to the longitudinal axis of the bone.

Correspondingly, the thickness of the at least one intermediate strut portion is a dimension of the at least one intermediate strut portion that is at right angles to the width and is intended to extend into the cancellous bone.

The to-be-bridged opening is preferably a wedge-shaped opening. The apertures are preferably configured to include a screwed hole with a threaded inner circumference. In an alternative preferred embodiment, the apertures can be configured to receive any type of bone fastener, such as a pin or blade, or any other suitable type of bone fastener.

The osteotomy implant according to the present invention preferably comprises an intermediate strut. However, in further preferred embodiments, the osteotomy implant can include more than one intermediate strut portion, such as two intermediate strut portions, three intermediate strut portions, or more intermediate strut portions.

The osteotomy implant is preferably made of a biocompatible material such as stainless steel, titanium, a biocompatible polymer such as polyetheretherketone (PEEK), or a biocompatible metal alloy.

In the context of this application, the terms "proximal" and "distal" are used to define the position of a particular portion of the osteotomy implant relative to the attachment point of the extremity. Go to the attachment point. That is, the component that is "remote" is further away from the limb-to-body attachment point than the component that is "proximal".

Preferably, the at least one intermediate pillar portion has a height greater than the width of the at least one intermediate pillar portion. The length of the at least one intermediate strut is understood a distance from the distal end portion of the at least one intermediate strut portion to the proximal end portion. Providing a height greater than the width allows for a large opening to be spanned while still not blocking the large extension of the edge of the opening by the osteotomy implant.

Preferably, the ratio of the width to the thickness of the at least one intermediate post portion is at least 1:1, preferably greater than 1:2.5. These ratios have shown a very strong support for the opening while the implant is only insignificantly blocking the edge of the opening.

The at least one intermediate post portion preferably has a rectangular cross section. This condition provides the at least one intermediate strut with good resilience against the bending forces applied throughout the opening in the target bone.

Further preferably, the at least one intermediate post portion has a rectangular parallelepiped shape, that is, all surfaces of the at least one intermediate post portion are disposed at right angles to each other. The cuboid shape allows for a highly stable intermediate strut, especially against compression and bending forces, while keeping the size to a minimum.

Preferably, the proximal portion and/or the distal portion comprises two or more cylindrical bodies that are linked to each other and have substantially parallel central axes, wherein each of the cylindrical bodies One includes an aperture for receiving a bone fixation element.

Providing a cylindrical body around the apertures for receiving a bone fixation element increases the stability of the osteotomy implant because any force exerted by the bone fixation elements on the apertures can be reliably Transfer to the at least one intermediate strut without any risk of breakage.

Preferably, the two or more cylindrical bodies are tapered toward the end intended to be inserted into the bone. Providing a tapered cylindrical body facilitates insertion of the osteotomy implant into the bone.

Preferably, the at least one aperture has an axis oriented at an acute angle relative to a central axis of the respective cylindrical body. This situation allows the osteotomy implant of the present creation to be anchored in a larger support area in the bone.

Preferably, the proximal end portion and the distal end portion both comprise two cylindrical bodies, wherein each of the proximal end portion and the distal end portion has a central axis from its respective cylindrical body An axis that is pointed at an acute angle in opposite directions to each other. The axes are thereby preferably arranged in a plane at right angles to the longitudinal axis of the at least one intermediate strut, that is, the axes are spaced apart from each other in the plane. This situation allows the support area within the bone to be maximized because the two bone anchors inserted in the apertures will point away from each other.

Preferably, the axis of the two apertures of the proximal portion and/or the axes of the two apertures of the distal portion are at an angle of at least 2° with respect to each other, more preferably at least 8°, optimally It is an angle of 11° to 30°.

Thereby, the axes are preferably located in a plane at right angles to the longitudinal axis of the at least one intermediate post portion. It has been found that, at such preferred angles, optimal anchoring of the proximal portion and/or the distal portion within a bone can be achieved.

Preferably, the angle between the axes is symmetrically arranged with respect to the length axis of the at least one intermediate strut portion, that is, the angle between each axis enclosing itself and the length axis of the at least one intermediate strut portion Half of it. For example, if the angle between the axes is 15°, then each axis will be at an angle of 7.5° to the length axis. The symmetric configuration of the axes has the advantage that the osteotomy implant can be used for osteotomy in the left and right tibia. If the axes are not symmetrically arranged with respect to the longitudinal axis of the at least one intermediate strut, it will be necessary to provide different osteotomy implants for osteotomy in the left and right tibia.

Alternatively, the angle between the axes is asymmetrically arranged with respect to the length axis of the at least one intermediate post portion. Thus, different osteotomy implants adapted to the left tibia bone and the right tibia bone can be provided. An advantage of providing an osteotomy implant for the left tibia and the right tibia is that the outer contour of the osteotomy implant (especially the outer contour of the at least one intermediate strut) is specifically shaped to conform to the tibia The outer shape of the cortex thus reduces the protrusion of the osteotomy implant and thus reduces the risk of soft tissue irritation.

Generally, the smaller the angle between the axes, the longer the bone fixation element can be used without the bone fixation elements being outside the bone (e.g., at the location of the bone relative to the osteotomy implant) Any of the outstanding risks of the side.

Further preferably, the axes may be configured such that once the osteotomy implant is implanted into a bone, the axes are inclined toward the caudal or cranial side. Essentially, the axis of the distal portion and/or the aperture of the proximal portion is disposed in a plane that is disposed at an oblique angle relative to a plane spanned by a central axis of the respective cylindrical body. The angle of inclination is preferably from 1 to 15 and more preferably from 3 to 6. Optimally, once the osteotomy implant is implanted into a bone, the axis of the proximal end aperture is configured to be oriented in the caudal direction and the axis of the distal end aperture is configured In order to be oriented in the direction of the cranial side.

Alternatively, the axes of the two apertures of the proximal portion are at an angle greater than 30° with respect to each other, preferably from 65° to 75°.

Further preferably, the axes of the two apertures of the distal portion are likewise at an angle greater than 30° with respect to each other, preferably from 65° to 75°.

Preferably, the proximal portion and/or the distal portion includes two cylindrical bodies that are linked to each other and each include an aperture having an axis that is parallel to each other.

In an alternative preferred embodiment, the proximal portion and/or the distal portion comprises two cylindrical bodies that are linked to each other and each comprise an aperture having an axis, wherein the apertures The axes are configured to preferably intersect one another at a location within the target bone.

The osteotomy implant preferably includes a wedge shaped bone graft or a wedge shaped artificial bone that can be assembled with the at least one intermediate post. This situation allows for optimal bridging of the osteotomy gap in the bone because the bone graft or artificial bone provides bone ingrowth to bridge the osteotomy gap while the osteotomy implant transmission is applied to the cut Any load on the osteosynthesis gap. The assembly of the wedge shaped bone graft or the wedge shaped artificial bone preferably belongs to a form-fit type.

The application further relates to a kit comprising an osteotomy implant according to the present invention, at least one wedge-shaped test septum element, and a bone layer preparation guide.

The wedge shaped test septum is used to transiently fill a wedge shaped osteotomy gap and to keep the wedge shaped osteotomy gap open while using the bone to prepare the introducer. The bone preparation introducer includes a drilling and sawing guide to allow the surgeon to create the necessary holes and to remove the incision for insertion of the osteotomy implant according to the present invention.

Other advantageous embodiments and combinations of features are derived from the following detailed description and the general patent claims.

1‧‧‧ osteotomy implant assembly

10, 10.1, 10.2, 10.3, 10.4‧‧‧ osteotomy implants

11‧‧‧ Near end

12‧‧‧First cylindrical body

13‧‧‧Second cylindrical body

14‧‧‧First pore

15‧‧‧second pore

20‧‧‧ distal end

21‧‧‧ Third cylindrical body

22‧‧‧Four cylindrical body

23‧‧‧ third aperture

24‧‧‧fourth pore

30‧‧‧ Middle pillar

31‧‧‧ front

40‧‧‧Sacral bones

41‧‧‧ osteotomy opening

42‧‧‧ proximal end of the humerus

43‧‧‧Bone layer

44‧‧‧ first hole

45‧‧‧second hole

46‧‧‧ third hole

47‧‧‧ fourth hole

48‧‧‧ trench

50a to 50d‧‧‧ bone screws

51a to 51d‧‧‧K wire

55‧‧‧Wedge-shaped bone graft

60,110‧‧‧Bone preparation equipment

61a to 61d, 111a to 111d‧‧‧ parallel holes

62, 112‧‧‧ saw cutting and milling slots

63, 123‧‧‧ milling tools

64‧‧‧Intubation drill

65, 122‧‧ ‧ stop

70‧‧‧ fifth pore

71‧‧‧Compression screws

72‧‧‧ center axis

100‧‧‧Test septum appliances

101‧‧‧Wedge shaped body

102‧‧‧First cylindrical protrusion

103‧‧‧Second cylindrical protrusion

104‧‧‧ recessed

105‧‧‧handle

106‧‧‧Fixed holes

113‧‧‧ Guide hole

114‧‧‧ guiding recess

120‧‧‧K wire

121‧‧‧ drill bit

130‧‧‧Wedge-shaped graft

A‧‧‧Support area

H, H1, H2, H3, H4‧‧‧ height

T‧‧‧depth or thickness

W‧‧‧Width

W1‧‧‧ first width

W2‧‧‧ second width

X1, X2, X3, X4‧‧‧ central axis

Y1, Y2, Y3, Y4‧‧‧ axis

A schematic representation of an embodiment is illustrated: Figures 1a and 1b are osteotomy implant assemblies having an osteotomy implant according to the present invention; Figures 2a and 2b are four bone screws according to Figure 1 Osteotomy implant assembly; Figures 3a to 3g are open wedge cuts using an osteotomy implant according to the present invention Different implantation steps of orthopedics; Figures 4a and 4b are instruments for implanting a preferred surgical technique for an osteotomy implant according to the present invention; Figures 5a to 5i are for the use of a test spacer device and bone layer preparation The device is preferably a surgical procedure for implanting an osteotomy implant according to the present invention; FIG. 6 is a plurality of osteotomy implants having different lengths according to the present invention; FIGS. 7a to 7c are osteotomy according to the present invention. A second embodiment of a surgical implant; Figures 8a and 8b are a third embodiment of an osteotomy implant according to the present invention.

In the figures, the same components are given the same component symbols.

1a and 1b show an osteotomy implant assembly 1 for bridging an osteotomy opening or resection in a target bone in a substantially countersunk manner. The osteotomy implant 10 comprises a proximal end 11 having two uniform or linked cylindrical bodies 12, 13 having substantially parallel central axes X1, X2. The first cylindrical body 12 and the second cylindrical body 13 each comprise apertures 14, 15 for receiving bone fixation elements. In a preferred embodiment, the apertures 14, 15 are oriented obliquely, causing their respective axes Y1, Y2 to be oriented.

Furthermore, the osteotomy implant 10 comprises a distal end portion 20 having two uniform or linked cylindrical bodies 21, 22 having substantially parallel central axes X3, X4. The third cylindrical body 21 and the fourth cylindrical body 22 each also include apertures 23, 24 for receiving bone fixation elements. In a preferred embodiment, the two apertures 23, 24 of the distal portion 20 are oriented obliquely, thereby causing the orientation of their respective axes Y3, Y4.

Connecting the proximal end by a middle pillar portion 30 having a quadrangular cross section The portion 11 and the distal end portion 20, wherein the width W of the intermediate post portion 30 is equal to or smaller than the depth or thickness T of the intermediate post portion 30. In a preferred embodiment, the connecting intermediate post portion 30 has a width W to thickness T ratio of at least 1:1, preferably a width W to thickness T ratio greater than 1:2.5.

In contrast to the prior art bone plates, the thickness T is not kept small to prevent soft tissue irritation, but the thickness T of the middle strut portion 30 is independent of soft tissue stimulation due to the expected placement of the head. The front portion 31 of the connecting intermediate pillar portion 30 is anatomically shaped to follow the outer contour of the target bone. In an alternative embodiment, the proximal portion 11 and the distal portion 20 are joined by a plurality of intermediate post portions (not shown).

In an alternative embodiment, the osteotomy implant 10 can comprise unequal amounts of proximal cylindrical bodies 12, 13 and distal cylindrical bodies 21, 22, proximal cylindrical bodies 12, 13 and distal cylinders The shaped bodies 21, 22 have apertures 14, 15, 23, 24 for receiving bone screws 50a to 50d. For example, the proximal portion 11 can comprise three cylindrical bodies due to the larger cross section of the bone toward its proximal end, and the distal portion 20 comprises only two cylindrical bodies.

1b illustrates the orientation of the axes Y1, Y2, Y3, Y4 of the four apertures 14, 15, 23, 24 within the osteotomy implant 10, which are shown from the proximal end portion 11 toward the distal end portion 20. The first cylindrical body 12 and the second cylindrical body 13 each have a central axis X1, X2 that is substantially parallel to each other. The same applies to the third cylindrical body 21 and the fourth cylindrical body 22, respectively, each having a central axis X3, X4. The two axes X3, X4 are also substantially parallel to the central axes X1, X2 of the first cylindrical body 12 and the second cylindrical body 13.

In addition, the first aperture 14 has an axis Y1 disposed at an angle to the central axis X1 of the first cylindrical body 12. The same situation applies to the other three pores 15, 23, 24 each having an axis Y2, Y3, Y4 disposed at an angle to the central axes X2, X3, X4 of their respective cylindrical bodies 13, 21, 22. The axis Y2 of the second aperture 15 branches into the opposite direction of the axis Y1 of the first aperture 14. The same applies to the axes Y3, Y4 of the third aperture 23 and the fourth aperture 24.

2a and 2b show an osteotomy implant assembly 1 having an osteotomy implant 10 and four bone screws 50a to 50d according to Fig. 1a. A bone screw is inserted into each of the four apertures 14, 15, 23, 24 of the osteotomy implant 10. The bifurcation axes Y1, Y2 of the first aperture 14 and the second aperture 15 result in the division of the respective bone screws 50a, 50b. Due to the bifurcation of the bone screws 50a, 50b, a wider support area A is obtained than the bone screws 50a, 50b placed in parallel, wherein the implant 10 maintains a small overall width.

Figure 2b shows the osteotomy implant assembly 1 in the same view as Figure 1b, however, four bone screws 50a to 50d are inserted into the apertures 14, 15, 23, 24.

Figures 3a through 3g show different implantation steps of an open wedge osteotomy using the present osteotomy implant 10 according to the present teachings.

Figure 3a shows a wedge shaped bone graft 55, or alternatively an artificial implant inserted into the osteotomy opening 41 in the humeral bone 40. The wedge shaped bone graft 55 raises the proximal end 42 of the tibia and corrects the leg axis.

Figure 3b shows a bone layer preparation device 60 positioned in abutment with the tibia bone 40 and secured using K-wires 51a to 51d. The bone layer preparation device 60 includes a plurality of substantially parallel holes 61a to 61d for accommodating the K wires 51a to 51d, and a sawing or milling slot 62. The bone layer preparation device 60 is positioned to bridge the osteotomy opening 41, wherein the first parallel hole 61a and the second parallel hole 61b are disposed in the osteotomy opening 41 On the proximal side, the third parallel hole 61c and the fourth parallel hole 61d are disposed on the distal end side of the osteotomy opening 41.

The groove 48 is cut into the tibia bone 40 and the wedge-shaped bone graft 55 by sawing or milling (e.g., using the milling tool 63) by milling the slot 62 as shown in Figure 3c. The groove 48 extends from the bone at the proximal end of the osteotomy opening 41 to the bone at the distal end of the osteotomy opening 41. In a subsequent step, the appliance is removed. Now, in the case where the cannulated drill bit 64 having the stopper 65 is used, the K wires 51a to 51d are each excessively drilled to a predetermined depth as shown in Fig. 3d.

3e shows the prepared bone layer 43 in the humeral bone 40 around the osteotomy opening 41. The bone layer 43 includes a first aperture 44 and a second aperture 45 located on the proximal side of the osteotomy opening 41, the two apertures 44, 45 being linked together and aligned substantially parallel to one another. Additionally, the third aperture 46 and the fourth aperture 47 are located on the distal side of the osteotomy opening 41, which are linked together and disposed substantially parallel to one another. The grooves 48 thereby span from the proximal holes 44, 45 to the distal holes 46, 47.

Figure 3f shows an osteotomy implant 10 aligned with the bone layer 43. The substantially parallel proximal cylindrical bodies 13, 14 and the distal cylindrical bodies 21, 22 of the osteotomy implant 10 are aligned with the substantially parallel holes 44, 45, 46, 47 of the bone layer 43, and the intermediate post portion 30 is aligned with the groove 48.

The osteotomy implant 10 is then inserted into the bone layer 43 and the bone screws 50a to 50d are inserted into the four apertures 14, 15, 23, 24. Figure 3g shows an osteotomy implant assembly 1 implanted in the tibia 40. The osteotomy implant assembly 1 bridges the osteotomy opening 41 and transfers the weight on the proximal tibia 42 to the distal tibia via the wedge 55 and the load sharing configuration of the osteotomy implant 10.

The implant assembly according to the above technique is also suitable for cutting the closed wedge Osteosynthesis is stabilized. In this case, the insertion of the wedge-shaped bone graft 55 into the osteotomy opening 41 is ignored.

In another alternative embodiment, an insertion instrument (not shown) is attached to the osteotomy implant 10 to allow insertion of the osteotomy implant 10 after preparation of the parallel holes 61a-61d and the milling slot 62. The insertion device includes an additional set of openings that correspond to the axes of the apertures 14, 15 in the proximal portion 11, and the apertures 23, 24 in the distal portion 20. The holes can be pre-drilled in the bone through the openings, which will receive the bone screws in subsequent steps. Alternatively, a drill sleeve having a conical external thread including an internal drill guide passage can be locked into each of the apertures 14, 15, 23, 24. Holes can be drilled into the bone by drilling through the sleeves.

Referring to Figures 4a and 4b, an instrument for a preferred surgical technique for implanting an osteotomy implant 10 is shown. Figure 4a shows a test spacer device 100 comprising a wedge-shaped body 101 having two cylindrical protrusions 102 and 103. The protrusion 103 ends in a curved shape and is connected to the handle 105. Furthermore, the wedge-shaped body 101 comprises a recess 104 between the cylindrical protrusion 102 and the cylindrical protrusion 103. The fixing hole 106 is additionally disposed in the wedge-shaped body 101.

In addition, a bone layer preparation device 110 is shown. The bone layer preparation device is shown in more detail in Figure 4b. The bone layer preparation implement 110 includes a plurality of second parallel holes 111a to 111d for guiding a drill having a stopper. Additionally, the bone layer preparation appliance 110 includes a second sawing or milling slot 112. In addition, the bone layer preparation device 110 includes a guide hole 113 and a guide recess 114 for assembling the device to the test spacer device 100.

Figures 5a through 5i illustrate a preferred surgical procedure for implanting the osteotomy implant 10 using the trial septum device 100 and the bone layer preparation device 110.

Figure 5a shows a humeral bone 40 having a partial osteotomy opening 41. will The wedge-shaped body 101 of the test septum device 100 is inserted into the osteotomy opening 41, which lifts the proximal tibia 42. As shown in Figure 5b, the proximal tibia 42 is raised by an angle a. The angle α corresponds to the wedge angle of the wedge-shaped body 101. Accordingly, the kit for osteotomy preferably includes a plurality of trial spacers 100 having a wedge-shaped body 101 having different angles to individually set the correction angle a.

Next, as shown in Figure 5c, the bone layer preparation device 110 is assembled to the test septum device 100 for engagement with the outer cortex of the humerus bone 40. Thereby, the bone layer preparation guide 110 is slidably assembled to the test spacer device 100, wherein the guide hole 113 and the guiding recess 114 are being combined with the two cylindrical protrusions 102 of the test spacer device 100, 103 cooperation. The sawing or milling slot 112 of the bone layer preparation appliance 110 is thereby aligned with the recess 104 of the wedge-shaped body 101, wherein the recess 104 facilitates the passage of milling or sawing tools, as will be more detailed later Explain.

Optionally, the K-wire 120 is used to secure the assembly of the test septum device 100 and the bone layer preparation guide 110 to the bone, and the K-wire 120 is inserted into the fixation hole 106 as shown in Figure 5d.

Figure 5e shows a first bone layer preparation step. Where a drill bit 121 having a stop 122 is used, four holes are drilled into the bone of the tibia 40 for receiving the osteotomy implant 10, wherein the drill bit is second parallel by the bone preparation device 110 The holes 111a to 111d are guided. Alternatively, the drill bit is not directly guided by the second parallel holes 111a to 111d, but by means of an intermediate member (such as a drill guide or a drill sleeve) placed in the second parallel holes 111a to 111d guide. An advantage of using the intermediate member is that the cutting edge of the drill bit can be completely surrounded by the intermediate member, thereby preventing the cutting edges from being blocked and blocked against the area where the second parallel holes 111a to 111d intersect the slot 112.

In the next step, as shown in Figure 5f, the groove 48 is cut into the bone by sawing or milling through the slot 112, the groove 48 extending from the proximal end of the osteotomy opening 41 to the osteotomy The bone at the distal end of the opening 41. Sawing or milling is performed using the milling tool 123. Alternatively, the slot 112 can be replaced by two substantially parallel slots that guide the pendulum saw. These slots can also be configured to meet toward each other.

Figure 5g shows the prepared bone layer 43 around the osteotomy opening 41 in the humeral bone 40 after removal of the instrument. The bone layer includes two link holes 44, 45 located at the proximal end of the osteotomy opening 41, and two link holes 46, 47 located at the distal end of the osteotomy opening 41. In addition, the bone layer 43 includes a groove 48 extending between the two holes 44, 45 at the proximal end of the osteotomy opening 41 and the two holes 46, 47 distal to the osteotomy opening 41.

In the next step, as shown in Figure 5h, the osteotomy implant 10 to which the bone graft wedge 130 is attached is inserted into the osteotomy opening 41 and the bone layer 43. The bone graft wedge 130 is preferably made of a bone graft, but may also be made of plastic (eg, polyetheretherketone (PEEK)) or metal (eg, porous titanium) or artificial bone substitutes or combinations thereof. to make. Alternatively, the bone graft material is not inserted into the osteotomy opening 41. Instead, the osteotomy opening 41 remains open so that natural bone can grow into the osteotomy opening 41 and gradually seal the osteotomy opening 41.

Figure 5i shows the final fixation of the osteotomy implant 10 using the bone screws 50a to 50d. In an alternative embodiment, the bone screws 50a through 50d can be self-drilling bone screws, and as a result, pre-drilling for placing the bone screws 50a through 50d would not be necessary. In another alternative embodiment, a pin or blade may be applied as the bone fixation element or combination thereof, wherein the apertures 14, 15, 23, 24 may be openings in the shape of circular holes, gaps, slits or slots.

Figure 6 shows a plurality of osteotomy implants 10.1, 10.2, 10.3, 10.4 each having a different height H1, H2, H3, H4 of the intermediate strut portion 30 to match the individual anatomy of the patient.

Figures 7a through 7c show a second embodiment of an osteotomy implant 10 in accordance with the present teachings. The middle pillar portion 30 has different widths W1, W2 on both sides thereof. The side of the intermediate pillar portion 30 intended to be disposed within the bone has a second width W2 that is smaller than the first width W1 of the front portion 31, and the front portion 31 is intended to be disposed parallel to the cortex of the bone. This feature can be identified by comparing Figure 7a showing the osteotomy implant 10 from the anterior portion 31 and Figure 7b showing the osteotomy implant 10 from the side intended to be placed within the bone.

In addition, the four cylindrical bodies 12, 13, 21, 22 are tapered toward their ends intended to be inserted into the bone, thereby providing a slight conical shape to the four cylindrical bodies 12, 13, 21, 22, such as by A side view of the osteotomy implant 10 as shown in Figure 7c can be seen. The use of tapered cylindrical bodies 12, 13, 21, 22 facilitates insertion of the osteotomy implant 10 into the bone. As will be appreciated by those skilled in the art, the pre-drilled holes in the bone will preferably have an equally conical shape.

Figures 8a and 8b show a third embodiment of an osteotomy implant 10 in accordance with the present teachings. This embodiment largely corresponds to the embodiment shown in FIG. 2. However, as shown in FIG. 8a, an additional fifth aperture 70 is disposed in the intermediate post portion 30. The fifth aperture 70 has a central axis 72 that includes an acute angle with the front portion 31 of the intermediate post portion 30. As seen in Figure 8b, the fifth aperture 70 can receive a compression screw 71. The compression screw 71 facilitates the creation of a compressive force throughout the osteotomy opening 41 that contributes to the primary stability and secondary stability of the implant.

In another alternative embodiment, the instrument for implantation and the osteotomy implant are part of a single use kit. Different sizes of implants will need to correspond to the shape of the implant Different bone preparation devices. An exemplary single use kit contains a combination of the following components:

Osteotomy implant 10;

● bone screws 50a to 50d having different lengths;

a pre-manufactured bone graft wedge 130;

At least one test spacer device 100;

● bone layer preparation device 110;

● drill bit 121;

● milling tool 123;

a K-wire 51 for fixing the bone layer preparation device 100;

a drill bit (not shown) for pre-drilling before inserting the bone screws 50a to 50d

● Inserting device (not shown);

● Screwdriver (not shown).

The detailed description focuses on open wedge osteotomy, however, osteotomy implants can also be used to close wedge osteotomy. In addition, the osteotomy implant 10 and various instruments can be adapted for application to other anatomical regions, for example, to the distal femur, proximal femur, tibia, spine, and the like.

10‧‧‧ osteotomy implants

11‧‧‧ Near end

12‧‧‧First cylindrical body

13‧‧‧Second cylindrical body

14‧‧‧First pore

15‧‧‧second pore

20‧‧‧ distal end

21‧‧‧ Third cylindrical body

22‧‧‧Four cylindrical body

23‧‧‧ third aperture

24‧‧‧fourth pore

30‧‧‧ Middle pillar

H‧‧‧ Height

T‧‧‧depth or thickness

W‧‧‧Width

Claims (13)

An osteotomy implant (10; 10.1, 10.2, 10.3, 10.4) for bridging an osteotomy opening or resection (41) in a target bone in a substantially countersunk manner, the osteotomy implant (10; 10.1, 10.2, 10.3, 10.4) comprising: a) a proximal end portion (11) having at least one aperture (14, 15) for receiving at least one bone screw (50a, 50b); b) a a distal end portion (20) having at least one aperture (23, 24) for receiving at least one bone screw (50c, 50d); c) at least one intermediate post portion (30) connecting the proximal end portion (11) And the distal end portion (20), characterized in that the at least one intermediate post portion (30) has a width (W) equal to or smaller than a thickness (T) of one of the at least one intermediate post portion (30). The osteotomy implant of claim 1, wherein the at least one intermediate post portion (30) has a height (L; L1) greater than the width (W) of the at least one intermediate post portion (30). L2, L3, L4). An osteotomy implant according to claim 1 or 2, wherein a ratio between the width (W) and the thickness (T) of the at least one intermediate post portion (30) is at least 1:1. It is preferably greater than 1:2.5. An osteotomy implant according to claim 1 or 2, wherein the at least one intermediate post portion (30) has a rectangular cross section. An osteotomy implant according to claim 1 or 2, wherein the at least one intermediate post portion (30) has a rectangular parallelepiped shape. An osteotomy implant according to claim 1 or 2, wherein the proximal portion (11) and/or the distal portion (20) comprise links to each other and have substantially parallel central axes (X1) Two or more cylindrical bodies (12, 13, 21, 22) of X2, X3, X4), wherein each of the cylindrical bodies (12, 13, 21, 22) is included for storage A hole (14, 15, 23, 24) of a bone screw (50a to 50d). An osteotomy implant according to claim 6, wherein the two or more cylindrical bodies (12, 13, 21, 22) are tapered at one end intended to be inserted into the bone. An osteotomy implant according to claim 6 wherein at least one of the apertures (14, 15, 23, 24) has an axis (Y1, Y2, Y3, Y4), the axis (Y1, Y2, Y3, Y4) is oriented at an acute angle with respect to the central axis (X1, X2, X3, X4) of the individual cylindrical bodies (12, 13, 21, 22). An osteotomy implant according to claim 8, wherein the axes (Y1, Y2) and/or the distal end of the two apertures (14, 15) of the proximal portion (11) 20) the axes (Y3, Y4) of the two apertures (23, 24) are at least 2° angle with respect to each other, more preferably at least 8° angle, optimally 11° to One angle of 30°. An osteotomy implant according to claim 8 wherein the axes (Y1, Y2) of the two apertures (14, 15) of the proximal portion (11) are greater than one of 30° relative to each other. The angle is preferably an angle of from 65 to 75 degrees. An osteotomy implant according to claim 1 or 2, wherein the proximal portion (11) and/or the distal portion (20) comprise two cylindrical bodies linked to each other, the pores (14) , 15, 23, 24) each have an axis (Y1, Y2, Y3, Y4), wherein the axes (Y1, Y2, Y3, Y4) of the apertures (14, 15, 23, 24) are parallel to each other. An osteotomy implant according to claim 1 or 2, wherein the proximal portion (11) and/or the distal portion (20) comprise two cylindrical bodies linked to each other, the pores (14) , 15, 23, 24) each having an axis (Y1, Y2, Y3, Y4), wherein the holes The axes (Y1, Y2, Y3, Y4) of the gaps (14, 15, 23, 24) are configured to preferably intersect one another at a location within the target bone. An osteotomy implant according to claim 1 or 2, wherein the osteotomy implant further comprises a wedge-shaped bone graft or wedge that can be assembled with the at least one intermediate post (30) Shaped artificial bone (55; 130).