CN117481740A

CN117481740A - Osteotomy positioning device

Info

Publication number: CN117481740A
Application number: CN202311362846.5A
Authority: CN
Inventors: 常涛; 袁方; 吴卫珂; 蔡振; 吴文娟
Original assignee: I Join Medical Technology Co ltd
Current assignee: I Join Medical Technology Co ltd
Priority date: 2023-10-19
Filing date: 2023-10-19
Publication date: 2024-02-02

Abstract

The present disclosure provides an osteotomy positioning device including a base and at least one first pad. The base has an upper surface with a first upper surface area and a second upper surface area, and the first upper surface area and the second upper surface area are located on both sides of the upper surface, and a lower surface for mounting to a pressure measurement device. The at least one first cushion piece is used for being installed on the first upper surface area or the second upper surface area of the base so as to position the tension balance position of two side parts of the bone end of the bone joint before osteotomy. The pressure measuring device is used for measuring the applied pressure when the first side part or the second side part of the two side parts of the bone end is pressed against at least one of the at least one first cushion piece, the first upper surface area and the second upper surface area. The osteotomy positioning device provided by the present disclosure can improve the accuracy of osteotomy and balance between the internal and external tension of the soft tissue after osteotomy.

Description

Osteotomy positioning device

Technical Field

The invention relates to the field of medical instruments, in particular to an osteotomy auxiliary tool used in knee joint replacement surgery.

Background

Knee replacement surgery is an effective means for treating knee-related diseases (particularly, bone wear, osteoarthritis, etc. in elderly patients). Traditional surgery generally includes: the distal femur and proximal tibia are first osteotomized, then the anterior femur condyle, the posterior femur condyle, and both of the oblique planes are osteotomized, and after all osteotomies are completed, the femoral prosthesis, tibial prosthesis, and meniscal pad are installed. The knee joint replacement operation can eliminate pain for the patient, so that the knee joint of the patient can obtain good functional reconstruction and the knee joint state of the patient can be improved, thereby improving the life quality of the patient.

For the femoral posterior condyle osteotomies in knee replacement surgery, a traditional osteotomy mode by experience is mainly adopted clinically at present. For example, a doctor or other operator first installs the auxiliary tool on the post-osteotomy tibial plateau, bringing the two bottom plates of the auxiliary tool into abutment with the posterior femoral condyles in flexion; then measuring the size of the femoral condyle, and adjusting the angle by using an adjusting knob on an auxiliary tool after the measurement is finished, so that the femoral posterior condyle is externally rotated by 3 degrees; then the position of the four-in-one osteotomy plate is determined by driving the fixing nails; finally, taking out the auxiliary tool but reserving the fixing nails, and installing the four-in-one osteotomy plate on the reserved fixing nails; finally, the four-in-one osteotomy plate is used for osteotomy of the femoral posterior condyles. However, this approach does not take into account the problem of balancing the medial and lateral tension of the soft tissue in the flexed state after osteotomy, and therefore, the tension needs to be adjusted by loosening the soft tissue later for the purpose of balancing the medial and lateral tension of the soft tissue in the flexed state. However, there are some drawbacks to loosening soft tissue. On the one hand, the soft tissue of the patient may be damaged by the loosened soft tissue, and on the other hand, even if the soft tissue is not damaged, the loosened soft tissue cannot always maintain the original mechanical properties.

In addition, in addition to the conventional osteotomies through experience, osteotomies through computer-aided navigation, such as robot osteotomies, are currently available. At present, the robot is adopted to cut bones, so that the bones can be cut on the far end of the femur, the front condyle, the back condyle of the femur and two inclined planes of the femur at one time, and an auxiliary tool is not required to be installed in the middle, so that a doctor can be liberated from the operation to a great extent, and the operation is simple compared with the traditional bone cutting mode. However, the robot osteotomy only considers the osteotomy thicknesses of the extension position and the flexion position (namely, the osteotomy thicknesses of the distal femur and the posterior femur condyles) to the greatest extent, and also does not consider the problem of balance of the medial and lateral tension of the soft tissue in the flexion state after osteotomy. Therefore, after the robot osteotomy, a doctor still needs to perform an empirical loosening process on the soft tissue to ensure the reliability of the knee prosthesis (including the femoral prosthesis, the tibial prosthesis, the meniscus liner, etc.) after being installed. In addition, the adoption of the robot osteotomy requires longer preoperative preparation time, compared with the traditional operation, the operation time is not shortened, and the learning curve of the robot osteotomy is longer. Meanwhile, the robot has high osteotomy cost and high operation cost, so that the robot is not widely popularized at present.

Disclosure of Invention

The technical scheme provided by the invention aims to solve at least one of the problems of unbalanced soft tissue tension, long osteotomy time, high osteotomy cost and the like after osteotomy in the prior art.

In one aspect of the present invention, there is provided an osteotomy positioning device, comprising: a base, the base having: an upper surface having a first upper surface area and a second upper surface area, wherein the first upper surface area and the second upper surface area are located on either side of the upper surface; and a lower surface for mounting to a pressure measurement device; and at least one first cushion for mounting on the first upper surface area or the second upper surface area of the base to position a tension balance position of bone end both side portions of the bone joint before osteotomy, wherein the pressure measuring device is for measuring an applied pressure when the first side portion or the second side portion of the bone end both side portions presses against at least one of the at least one first cushion, the first upper surface area, and the second upper surface area.

In at least one embodiment of one aspect of the invention, the first spacer is a spacer, a first one of the bone end side portions includes a posterior femoral condyle medial side, and a second one of the bone end side portions includes a posterior femoral condyle lateral side, the pressure measurement device is for mounting between a tibial plateau and a base of the osteotomy positioning device.

In at least one embodiment of one aspect of the present invention, the base has: a first mounting portion located at the first upper surface region; and a second mounting portion located at the second upper surface region, the first pad being configured to have a mounting engagement portion for engagement with the first mounting portion or the second mounting portion of the base to mount the first pad to the first upper surface region or the second upper surface region of the base.

In at least one embodiment of one aspect of the present invention, the first mounting portion and the second mounting portion are both clamping grooves and are separately disposed at two side edges of the base.

In at least one embodiment of one aspect of the invention, the first pad has an operative aperture for operatively engaging an auxiliary tool to disengage the mounting engagement portion of the first pad from the card slot, thereby removing the first pad from the edge of the base.

In at least one embodiment of one aspect of the invention, the upper surface of the base further has a third upper surface area that is closer to a front of the upper surface than the first and second upper surface areas, the osteotomy positioning device further includes a second pad for mounting to the third upper surface area of the base, and a top surface of the second pad for supporting an osteotomy plate to position the osteotomy plate.

In at least one embodiment of one aspect of the present invention, the second pad is a pad, the bottom surface of the second pad has at least one spacing hole, and the base has at least one spacing post located on a third upper surface area of the base, wherein the spacing post is configured to fit with the spacing hole of the second pad so that the second pad is removably mounted to the third upper surface area of the base.

In at least one embodiment of one aspect of the present invention, the osteotomy positioning device further includes a height measurement mechanism, the height measurement mechanism comprising: a shaped through hole located in the third upper surface area of the base; a scale, comprising: the tibial plateau comprises a body, a plurality of scales and a plurality of support rods, wherein the body is provided with scales for indicating the distance from the corresponding scale mark to the tibial plateau; the third installation part is used for being installed in a matched mode with the special-shaped through hole; wherein the scale is used to measure the distance of the top surface of the second pad from the tibial plateau.

In at least one embodiment of one aspect of the present invention, the osteotomy positioning device further includes a height adjustment mechanism for adjusting a distance between a bottom surface of the pad and an upper surface of the base, the height adjustment mechanism comprising at least: a stem portion; and a through hole located in a third upper surface region of the base, wherein an end of the lever portion protrudes through the through hole from an upper surface of the base and abuts against a bottom surface of the second pad located above the through hole, and a distance by which the end of the lever portion protrudes from the upper surface of the base is adjustable.

In at least one embodiment of one aspect of the present invention, the lever portion is a knob having a threaded rod, and the through hole is a threaded hole, the bottom surface of the second pad has a plurality of limiting holes, and the third upper surface area of the base has a plurality of limiting posts, wherein the plurality of limiting posts are symmetrically distributed with respect to the threaded hole.

In at least one embodiment of one aspect of the invention, the lower surface of the base is mounted in a limited position to the top surface of the pressure measurement device by a post-to-hole mating arrangement.

In at least one embodiment of one aspect of the invention, the lower surface of the base has a first lower surface area and a second lower surface area opposite the first upper surface area and the second upper surface area, respectively, wherein the first lower surface area and the second lower surface area have at least one contact portion, respectively, for contacting a corresponding pressure test portion on the pressure measuring device.

Compared with the prior art, the technical scheme provided by the invention has at least one or more of the following advantages:

(1) By utilizing the osteotomy positioning device disclosed by the invention, an operator (such as a doctor) can be allowed to directly measure and adjust the pressure of the inner side and the outer side of the femoral posterior condyle in a buckling state in real time before osteotomy, and osteotomy is performed again under the condition that the lateral pressure of the femoral posterior condyle and the lateral pressure of the femoral posterior condyle are basically balanced, so that the accuracy of osteotomy and the balance between the tension of the inner side and the lateral side of the soft tissue after osteotomy can be improved, the stability of the postoperative knee joint can be enhanced, the requirement on the soft tissue after the operation is avoided, and the soft tissue of a patient can keep the original mechanical function as much as possible.

(2) The osteotomy positioning device can be matched with the existing four-in-one osteotomy plate in the market, and has strong wildness and wide application range.

(3) The osteotomy positioning device can adjust the height of the osteotomy plate, thereby meeting the requirements of different osteotomy amounts.

(4) The osteotomy positioning device has a simple overall structure, is convenient to match with the osteotomy plate, and can accurately position the osteotomy position of the femoral posterior condyle without complex operation procedures.

Drawings

To further clarify the above and other advantages and features of embodiments of the present invention, a more particular description of embodiments of the invention will be rendered by reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.

FIG. 1 illustrates an exploded view of an osteotomy positioning device, according to an embodiment of the invention.

Fig. 2 shows a schematic view of the structure of the upper surface of the base in the osteotomy positioning device according to an embodiment of the invention.

Fig. 3 shows a schematic view of the structure of the lower surface of the base in the osteotomy positioning device according to an embodiment of the invention.

Fig. 4 shows a schematic structural view of a medial spacer in an osteotomy positioning device according to an embodiment of the invention.

Fig. 5 shows a schematic structural view of a scale in an osteotomy positioning device according to an embodiment of the invention.

Fig. 6 shows a schematic structural view of a prior art osteotomy plate.

Fig. 7 shows a schematic structural diagram of a conventional pressure measuring device.

Fig. 8A illustrates a method for adjusting the medial and lateral femoral condyle pressure in accordance with an embodiment of the present invention.

Fig. 8B illustrates a method for positioning an osteotomy plate, according to an embodiment of the invention.

Fig. 9 is a schematic view showing an operation state of adjusting medial and lateral pressures of a posterior femoral condyle using the osteotomy positioning device of the present invention.

Fig. 10 is a schematic view showing an operation state of positioning an osteotomy plate using the osteotomy positioning device of the present invention.

Fig. 11 is a schematic view showing an operation state in which an osteotomy plate is fixed to a femoral platform after the osteotomy positioning device of the present invention is removed.

Detailed Description

The present invention will be further described in conjunction with the following specific embodiments and the accompanying drawings, in which further details are set forth in order to provide a thorough understanding of the present invention, but it will be apparent that the present invention can be practiced in many other ways than those described herein, and that those skilled in the art may make a similar promotion or deduction depending upon practical circumstances without departing from the spirit of the present invention, and therefore, the scope of the present invention should not be limited in its context to such specific embodiments.

This application uses specific words to describe embodiments of the application. Reference to "one embodiment," "other embodiments," and/or "some embodiments" means that a particular feature, structure, or characteristic is associated with at least one embodiment of the present application. Thus, it should be emphasized and should be appreciated that two or more references to "one embodiment" or "other embodiments" or "some embodiments" in various positions in this specification are not necessarily referring to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of the present application may be combined as suitable.

It should be noted that in order to simplify the presentation of the disclosure herein, and thereby aid in understanding one or more embodiments, the disclosure herein may sometimes incorporate features from the description of embodiments of the disclosure herein into one embodiment, drawings, or description thereof. This method of disclosure, however, is not intended to imply that more features than are presented in the claims are required for the subject application.

In this context, the expressions referring to "inner" and "outer" in describing the osteotomy positioning device 1 are based on the scenario in which the osteotomy positioning device 1 is to be applied to a left side portion of the body (e.g., the left leg), wherein "inner" means close to the midline of the body and "outer" means away from the midline of the body. When the osteotomy positioning device 1 is applied to a right side portion of the body (e.g., the right leg), the expressions referred to herein as "inner" and "outer" when describing the osteotomy positioning device 1 should be interchanged. Further, "front" herein means a location near the operator in operation.

As used herein, the term "tension balance position" refers to the position or relative position of the two side portions of the bone end when the soft tissue tension around the two side portions of the bone end of the bone joint is balanced. For example, when the knee joint is in a 90 ° flexion position, the soft tissue tension around the medial femoral posterior condyle portion and the lateral femoral posterior condyle portion is balanced, the position or relative position of the medial femoral posterior condyle and the lateral femoral posterior condyle.

Fig. 1 shows an exploded schematic view of an osteotomy positioning device 1 according to an embodiment of the invention. As shown in fig. 1, the osteotomy positioning device 1 may include a base 10, shims (e.g., medial shim 21 and lateral shim 22), a spacer 30, a height measurement mechanism, a height adjustment mechanism, and the like.

The base 10 of the osteotomy positioning device 1 may have an upper surface 11 and a lower surface 13. Fig. 2 shows a schematic view of the structure of the upper surface 11 of the base of the osteotomy positioning device 1 according to an embodiment of the invention. Fig. 3 shows a schematic view of the structure of the lower surface 13 of the base of the osteotomy positioning device 1 according to an embodiment of the invention. As shown in fig. 2 and 3, the base 10 may be generally configured as a U-shaped structure. In other embodiments, the base 10 may also be configured to have other shapes, such as rectangular, oval, etc.

The osteotomy positioning device 1 may include a spacer that may be placed on the upper surface 11 of the base 10. Referring to fig. 1 and 2, in one embodiment, the upper surface 11 of the base 10 may have an upper surface inside region 111 and an upper surface outside region 113, which are located on either side of the upper surface 11, respectively. The inner and outer shims 21 and 22 may be placed on the upper surface inner region 111 and the upper surface outer region 113, respectively. The base 10 may also have an inner slot 12 and an outer slot 14. The inner clamping groove 12 may be provided at the left side edge of the upper surface inner side region 111 for cooperating with the mounting portion 211 of the inner pad 21 so as to mount the inner pad 21 on the upper surface inner side region 111 of the base 10. The outer clamping groove 14 may be provided at the right edge of the upper surface outer region 113 for cooperating with the mounting portion of the outer gasket 22 to facilitate mounting of the outer gasket 22 on the upper surface outer region 113 of the base 10. Providing the inner and outer clamping grooves 12 and 14 at both side edges of the base 10 allows the inner and outer shims 21 and 22 to be easily installed to or removed from the base 10 from the edges of the base 10. The contours of the inner and outer card slots 12, 14 may be configured in a non-circular configuration, which may prevent the inner and outer shims 21, 22 mounted to the upper surface inner and outer regions 111, 113 of the base 10 from rotating relative to the base 10.

Fig. 4 shows a schematic structural view of the inner spacer 21 in the osteotomy positioning device 1 according to an embodiment of the invention. The outside gasket 22 may be configured similarly to the inside gasket 21, for example, the outside gasket 22 may be configured as a mirror image structure with the inside gasket 21. As shown in fig. 4, in an embodiment, the inner pad 21 may have a mounting portion 211 and an operation hole 213. The mounting portion 211 may cooperate with the inner clamping groove 12 to mount the inner pad 21 to the upper surface inner region 111 of the base 10. An operator (e.g., doctor) can remove the inside spacer 21 from the edge of the base 10 by disengaging the mounting portion 211 of the inside spacer 21 from the inner clamping groove 12 by cooperating with the operation hole 213 using an auxiliary tool.

In other embodiments, the inboard gasket 21 may be mounted to the upper surface inboard region 111 of the base 10 by a hole-and-post mating arrangement. For example, the upper surface inside region 111 of the base 10 may have mounting posts, the inside gasket 21 may have mounting through holes, and one or more inside gaskets 21 may be mounted or stacked onto the upper surface inside region 111 of the base 10 by cooperation between the mounting through holes thereon and the mounting posts of the upper surface inside region 111 of the base 10. The mounting through holes in the above-described hole-post mating structure may be configured as shaped holes to prevent the inner pad 21 mounted to the upper surface inner region 111 of the base 10 from rotating relative to the base 10.

It should be understood that the shape of the inboard pad 21 shown in fig. 1 and 4 is merely exemplary and is not intended to be limiting. The shape of the medial and lateral shims 21, 22 may be designed by those skilled in the art as desired, so long as the pressure measurement requirements of the pressure measurement device (e.g., pressure measurement device 70 described below with reference to fig. 7) are met and the bone end portions (e.g., medial femoral posterior condyle, lateral femoral posterior condyle) on which the pressure is to be measured are allowed to rest.

In some embodiments, the inboard 21 or outboard 22 shims may be configured to have a thickness of about 1mm, 2mm, or other suitable thickness. In operation, an operator (e.g., a doctor) may mount one or more medial shims 21 of a suitable thickness to the upper surface medial region 111 of the base 10, and/or one or more lateral shims 22 of a suitable thickness to the upper surface lateral region 113 of the base 10, as desired.

The osteotomy positioning device 1 may further include a spacer 30, the spacer 30 being mountable on the upper surface 11 of the base 10. Referring back to fig. 1 and 2, in one embodiment, the upper surface 11 of the base 10 may also have a front region 112, wherein the front region 112 is closer to an operator (e.g., a doctor) than the upper surface inside region 111 and the upper surface outside region 113 in operation. The front region 112 may have two stop posts 115 therein and the spacer 30 may have two stop holes 32. The spacing holes 32 shown in fig. 1 are configured as through holes that extend from the bottom surface of the spacer 30 to the top surface 31 of the spacer 30. However, in other embodiments, the stop hole 32 may be configured as a blind hole that may extend from the bottom surface of the spacer 30 to below the top surface 31 of the spacer 30. The spacer 30 may be installed into the front region 112 of the base 10 by engagement between the stop posts 115 in the front region 112 of the base 10 and the stop holes 32 of the spacer 30. In other embodiments, the front region 112 of the upper surface 11 of the base 10 may have one or more retaining holes therein, which may be configured as through holes, each for mating with a corresponding retaining post at the bottom of the cushion block 30 to mount the cushion block 30 to the front region 112 of the base 10. The hole post mating structure between the spacer 30 and the front region 112 of the base 10 allows the spacer 30 to be removable and the spacer 30 to be retained on the front region 112 of the base 10. In some embodiments, there may be only a pair of hole-post mating structures between the spacer 30 and the front region 112 of the base 10.

As shown in FIG. 1, in one embodiment, the spacer 30 may be generally configured as a U-shaped structure having a top surface 31 that includes left and right discontinuous top surfaces. The recess formed between the two top surfaces of the left and right discontinuous surfaces may be used to accommodate the bottom configuration of an osteotomy plate to be mounted to the top surface of the block 30 so that the osteotomy plate rests smoothly on the top surface of the block 30. The two top surfaces may be parallel to the bottom surface of the spacer 30 and at the same height relative to the bottom surface of the spacer 30 so that the osteotomy plate to be mounted to the top surface of the spacer 30 is stably mounted thereto. In other embodiments, the top surface 31 of the spacer 30 may be configured as a continuous top surface and parallel to the bottom surface of the spacer 30, such as convex or rectangular, depending on the bottom configuration of the osteotomy plate to be mounted to the top surface of the spacer 30.

The osteotomy positioning device 1 may also include a height measurement mechanism for measuring the height of the top surface 31 of the block 30. With continued reference to fig. 1 and 2, in one embodiment, the chassis 10 may also have two shaped through holes 117, which two shaped through holes 117 may be positioned on either side of the front region 112 of the chassis 10. Referring to fig. 3, a shaped through hole 117 may extend through the base 10 and a platform 133 protruding from the lower surface 13 of the base 10. The shaped through hole 117 may be used to mount the scale 50. The operator can select one of the two shaped through holes 117 to install the scale 50 according to the convenience of the operator.

Referring to fig. 5, fig. 5 shows a schematic structural view of a scale 50 in the osteotomy positioning device 1 according to an embodiment of the invention. As shown in fig. 5, the scale 50 may have a body 51 and a mounting portion 52. The scale 50 may be configured to only allow the mounting portion 52 to pass through the shaped through hole 117, wherein the shape and size of the mounting portion 52 may mate with the shaped through hole 117. When the mounting scale 50 is operated, the mounting portion 52 may be passed through the profiled through hole 117 such that the bottom surface 53 of the mounting portion 52 is in contact with a pressure measuring device (e.g., the pressure measuring device 70 described below with reference to fig. 7) located below the base 10, while the body 51 is positioned on the front region 112 of the base 10 so as not to pass through the profiled through hole 117. The body 51 of the scale 50 may have graduations, wherein each graduation may be delineated based on the distance of the corresponding graduation line from the bottom surface 53 of the scale 50, as well as the thickness of a pressure measurement device used in conjunction with the osteotomy positioning device 1, so that the distance of the corresponding graduation line from the tibial plateau 91 (tibial plateau 91 will be described below in connection with fig. 9) may be indicated. The contoured through hole 117 is positioned such that when the scale 50 is installed therein, the body 51 of the scale 50 may be adjacent to the spacer 30 to facilitate reading the height of the top surface 31 of the spacer 30, e.g., the height of the top surface 31 of the spacer 30 relative to the tibial plateau 91. The scale 50 and the profiled through hole 117 on the base 10 for fitting the scale 50 can form a height measuring mechanism. The present invention can prevent the scale 50 mounted to the upper surface 11 of the base 10 from rotating relative to the base 10 by mounting the scale 50 using a shaped through hole (e.g., a square hole or a polygonal hole) instead of a circular hole.

The osteotomy positioning device 1 may also include a height adjustment mechanism for adjusting the height of the spacer 30. With continued reference to fig. 1 and 2, in one embodiment, the base 10 may also have a threaded hole 15 through the base 10 in the front region 112 of the upper surface 11 for the knob 40 to be screwed into from below the base 10. The threaded bore 15 and knob 40 are operatively engaged to form a height adjustment mechanism for adjusting the height of the spacer 30. As shown in fig. 1, knob 40 may have a head 41 and a threaded rod 42. The end of the threaded rod 42 remote from the head 41 may be threaded into the threaded bore 15, protruding beyond the upper surface 11 of the base 10 and abutting the bottom surface of the spacer 30 above the threaded bore 15. By screwing the knob 40, the distance that the end of the threaded rod 42 remote from the head 41 protrudes beyond the upper surface 11 of the base 10, and thus the height of the top surface 31 of the spacer 30 relative to the base 10, can be adjusted so that an osteotomy plate (not shown in fig. 1 and 2, see fig. 6) subsequently mounted on the top surface 31 of the spacer 30 can be positioned in a desired position. Referring to fig. 6, fig. 6 shows a schematic view of the structure of a prior art osteotomy plate 60. Osteotomy plate 60 may be a four-in-one osteotomy plate as is commonly known in the market. As shown in fig. 6, the osteotomy plate 60 may have a femoral posterior condyle osteotomy groove 61 and a bottom surface 62. When the osteotomy plate 60 is mounted to the spacer 30, the bottom surface 62 of the osteotomy plate 60 may contact and conform to the top surface 31 of the spacer 30.

Referring to fig. 1, in an embodiment, two limiting holes 32 on the pad 30, which are respectively engaged with two limiting posts 115 of the base 10, may be symmetrically disposed with respect to a center line of the pad 30, and the threaded hole 15 is disposed at a center of symmetry of the two limiting posts 115 of the base 10 (e.g., a center of the two limiting posts 115), so that a knob 40 screwed into the threaded hole 15 may abut against the pad 30 at a middle position of a bottom of the pad 30, thereby enabling the pad 30 to smoothly move up and down with respect to the base 10 by a movement of the knob 40, and further improving a positioning accuracy of an osteotomy plate 60 subsequently mounted on the pad 30.

In other embodiments, the number and location of the stop posts 115 on the base 10, the number and location of the stop holes 32 on the spacer 30 that mate with the stop posts 115, and the location of the threaded holes 15 on the base 10 may vary depending on the particular implementation, so long as the knob 40 threaded into the threaded holes 15 may be made to abut the spacer 30 at an intermediate location at the bottom of the spacer 30.

In addition, in the process of adjusting the height of the cushion block, the hole column matching between the cushion block 30 and the base 10 can play a role in guiding the moving track of the cushion block 30. This may further improve the smoothness of the up and down movement of the spacer 30 relative to the base 10, and thus may further improve the positioning accuracy of the osteotomy plate 60 subsequently mounted on the spacer 30.

In other embodiments, the height of the spacer 30 relative to the base 10 may also be adjusted by other height adjustment mechanisms. For example, the other height adjustment mechanism may include a button, a ball screw, and a through hole through the base 10, wherein the button may have a head and a straight rod, and an end of the straight rod remote from the head may be inserted into the through hole of the base 10 and abut against a bottom surface of the pad 30 mounted on the upper surface 11 of the base 10. One end of the beaded screw has a retractable beaded ball and the other end of the beaded screw may be secured to the side of a boss (not shown) in the front region 112 of the base 10. When the spacer and the ball screw are installed in the front region 112 of the base 10, the ball of the ball screw may abut a side (e.g., left or right) of the spacer, which may have a plurality of sockets, each of which may be adapted to receive the ball of the ball screw. The sockets of the pad sides may be arranged at uniform intervals, for example, at 1mm intervals, along the height direction of the pad (e.g., a direction perpendicular to the bottom and top surfaces of the pad). In operation, a button may be pressed to adjust the height of the spacer relative to the base 10, while at the same time a retractable marble of a beaded screw secured to the boss side of the base 10 may slide into or out of the socket of the spacer side. When the height of the spacer is adjusted relative to the base 10, the ball of the ball screw may be positioned in a socket on the side of the spacer and thereby secure the spacer. In addition, the other height adjustment mechanism may also include a spring that may be sleeved over the straight bar of the button and may contact the head of the button at one end and the lower surface 13 of the base 10 at the other end. Through setting up the spring in addition, can control the operator and carry out the dynamics of pressing when highly regulated, prevent to press the button to the bottom because of pressing the dynamics too big in the short time to improve operator's operating comfort. In some embodiments, the other height adjustment mechanism may include two ball screws respectively secured to sides of two bosses on either side of the spacer, and the two sides of the spacer may be provided with a plurality of sockets respectively for operatively engaging the corresponding ball screws.

In addition, the osteotomy positioning device 1 may also include a stop and a contact portion. Referring back to fig. 3, in one embodiment, the lower surface 13 of the base 10 may have two stop posts 131 for mating with corresponding stop holes on the pressure measurement device 70 (not shown in fig. 3, see fig. 7) to mount the osteotomy positioning device 1 to the pressure measurement device 70. Referring to fig. 7, fig. 7 shows a schematic structural diagram of a conventional pressure measurement device 70. The pressure measurement device 70 may be a knee soft tissue pressure measurement device or other suitable pressure measurement device as described in the patent application publication number CN111419253 a. As shown in fig. 7, the pressure measuring device 70 may have two limiting holes 71 for inserting two limiting posts 131 of the lower surface 13 of the base 10, respectively. Referring back to fig. 3, the lower surface 13 of the base 10 may also have three inner side contact portions 132 and three outer side contact portions 134, located in the lower surface inner side region 135 and the lower surface outer side region 137 of the base 10, respectively, that may contact corresponding pressure test portions on the pressure measurement device 70, respectively. The lower surface inside region 135 of the base 10 may correspond to the upper surface inside region 111 of the base 10, and thus the pressure measuring device 70 may measure the pressure applied to the upper surface inside region 111 of the base 10 by the pressure measuring part. The lower surface outside area 137 of the base 10 may correspond to the upper surface outside area 113 of the base 10, and thus the pressure measuring device 70 may measure the pressure applied to the upper surface outside area 113 of the base 10 through the pressure measuring part. It should be understood that the number and arrangement of the inboard and outboard contacts 132, 134 of the lower surface 13 of the base 10 described above are illustrative and are not intended to limit the invention. The inner side contact 132 and the outer side contact 134 of the lower surface 13 of the base 10 may be provided as desired by a person skilled in the art (e.g. measurement requirements of a pressure measuring device).

The osteotomy positioning device 1 described above may be used to assist in the proper positioning of an osteotomy plate (e.g., osteotomy plate 60 shown in fig. 6) during a knee replacement procedure to support an operator (e.g., a physician) for accurate osteotomies using the osteotomy plate.

In knee replacement surgery, it is often required to first osteotomy at the distal femur and proximal tibia, then osteotomy at the anterior femur, posterior femur, and two oblique planes of the femur, and after all osteotomies are completed, the femoral prosthesis, tibial prosthesis, and meniscal liner are installed. The distal femur may form a femoral plateau after osteotomy and the proximal tibia may form a tibial plateau after osteotomy. In the straightened state of the knee joint, the gap G1 between the femoral and tibial plateau may form a joint gap in the straightened position of the knee joint. When the knee joint is in a buckling state, a joint gap of a buckling position of the knee joint can be formed by a gap between a rear condyle of the femur after the rear condyle is osteotomized and the tibia platform. In order to ensure that the knee joint has no pain or loose feeling during flexion and extension movement after the femoral prosthesis and the tibial prosthesis are implanted, the principle that the flexion and extension clearance are equal, namely the joint clearance of the knee joint flexion position is equal to the joint clearance of the knee joint extension position, is generally required to be satisfied. Therefore, after the distal femur osteotomy and the proximal tibia osteotomy are completed, based on the principle that the flexion and extension gaps are equal, the osteotomy amount of the posterior femur condyle osteotomy, that is, the target osteotomy amount, can be determined according to the joint gap of the knee joint straightening position (i.e., the gap G1 between the femoral plateau and the tibial plateau in the knee joint straightening state).

In addition, in knee replacement surgery, balancing of medial and lateral tension of the posterior femoral condyle soft tissue after osteotomy is also desirable to reduce the impact on knee stability and function due to imbalance of medial and lateral tension of the soft tissue. In this regard, the inventors devised the osteotomy positioning device 1 of the present invention, and the osteotomy positioning device 1 can achieve balancing of the medial and lateral pressures of the posterior condyle of the femur by measuring the pressure applied to the spacer, the medial upper surface region 111, and the lateral upper surface region 113 on the medial and lateral sides of the posterior condyle of the femur in flexion and adjusting the number of spacers on both sides in real time when the medial and lateral pressures are unbalanced, prior to osteotomy positioning of the osteotomy plate 60. It will be appreciated that when the medial and lateral femoral posterior condyle pressures are balanced, this means that the medial and lateral tension of the surrounding soft tissue is balanced. Therefore, the medial and lateral tension balance of the soft tissue can be realized by measuring and adjusting the medial and lateral pressures of the posterior femoral condyle in real time by using the osteotomy positioning device 1 provided by the invention.

For better understanding, the method of adjusting the medial-lateral femoral condyle pressure and positioning the osteotomy plate 60 using the osteotomy positioning device 1 of the present invention is illustratively described below.

Referring to fig. 8A, fig. 8A illustrates a method 810 for adjusting the medial-lateral pressure of the posterior femoral condyle in accordance with an embodiment of the present invention. In some embodiments, the method 810 may be performed using the osteotomy positioning device 1 and pressure measurement device 70 described above.

At step 811, a pre-measurement installation work is performed. In some embodiments, when an operator (e.g., a doctor) performs a pre-measurement installation work, the base 10 of the osteotomy positioning device 1 may first be mounted to the pressure measurement device 70, and then the base 10 and pressure measurement device 70 mounted together may be placed on the tibial plateau 91 as shown in fig. 9. Fig. 9 is a schematic view showing an operation state of adjusting the medial and lateral pressures of the posterior condyle of the femur using the osteotomy positioning device 1 of the present invention. Referring to fig. 9, when the pressure measuring device 70 is mounted on the tibial plateau 91 and the base 10 of the osteotomy positioning device 1, the bottom surface of the pressure measuring device 70 may contact the tibial plateau 91, and the superior medial and lateral surface regions 111, 113 of the base 10 may be located below the femoral posterior condyle medial 92 and lateral femoral posterior condyle 94, respectively. Next, the method 810 may proceed to step 812.

At step 812, the femoral posterior condylar medial pressure and the femoral posterior condylar lateral pressure are measured. In some embodiments, after installing the pressure measurement device 70 on the tibial plateau 91 and the base 10 in the osteotomy positioning device 1, the operator may bend the knee joint approximately 90 degrees to place it in flexion, as shown in figure 9. The medial femoral condyle 92 in the knee in flexion may contact and press against the medial upper surface area 111 of the base 10 therebelow and further exert pressure via the medial contact portion of the lower surface 13 of the base 10 against a corresponding pressure test portion of the pressure measurement device 70 located below the base 10. Likewise, the femoral posterior condyle lateral side 94 in a knee in flexion may contact and bear against the upper surface lateral region 113 of the base 10 therebelow and further exert pressure via the lateral contact portion of the lower surface 13 of the base 10 against a corresponding pressure test portion of the pressure measurement device 70 located below the base 10. At this time, the operator can obtain the pressure of the medial femoral condyle 92 and the pressure of the lateral femoral condyle 94 measured by the pressure measuring apparatus 70. Next, the method 810 may proceed to step 813.

At step 813, it is determined whether the absolute difference between the medial and lateral femoral condyles is less than a pressure difference threshold. In some embodiments, the pressure difference threshold may be any value between 30N-70N, for example, 30N, 40N, 67.5N, 70N. The operator may determine whether the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure obtained from pressure measurement apparatus 70 is less than a pressure difference threshold. When the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure is greater than or equal to the pressure difference threshold, the method 810 may proceed to step 814.

At step 814, either the inboard shim 21 or the outboard shim 22 is installed. In some embodiments, when it is determined that the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure is greater than or equal to the pressure difference threshold, the operator may position the medial shim 21 or shims 22 between the medial femoral condyle 92 and the medial upper surface region 111 of the base 10 or between the lateral femoral condyle 94 and the lateral upper surface region 113 of the base 10 to adjust the position or relative position of the medial femoral condyle 92 and the lateral femoral condyle 94 and position the tension balance position of the medial femoral posterior femoral condyle 92 and the lateral femoral condyle 94. When the medial femoral condyle 92 and the lateral femoral condyle 94 are in the tension-balanced position, the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure measured by the pressure measurement device 70 is less than a pressure difference threshold. For example, when the difference of the femoral posterior condylar lateral pressure minus the femoral posterior condylar lateral pressure is greater than or equal to the pressure difference threshold, the operator may place one or more medial shims 21 between the femoral posterior condylar medial 92 and the upper surface medial region 111 of the base 10 to distract the femoral posterior condylar medial portion such that the absolute difference between the femoral posterior condylar medial pressure and the femoral posterior condylar lateral pressure is less than the pressure difference threshold. For another example, when the difference of the medial femoral condyle pressure minus the lateral femoral condyle pressure is greater than or equal to the pressure difference threshold, the operator may place one or more lateral shims 22 between the lateral femoral condyle 94 and the lateral upper surface region 113 of the base 10 to distract the lateral femoral condyle portion such that the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure is less than the pressure difference threshold.

When the absolute difference between the medial femoral condyle pressure and the lateral femoral condyle pressure measured from pressure measurement apparatus 70 is less than the pressure difference threshold, method 810 may proceed to step 815.

At step 815, the method 810 for adjusting the medial-lateral pressure of the posterior femoral condyle ends.

Referring to fig. 8B, fig. 8B illustrates a method 820 for positioning an osteotomy plate 60, according to an embodiment of the invention. In some embodiments, method 820 may be performed using osteotomy positioning device 1 and osteotomy plate 60 described above. Method 820 may be performed after method 810. In some embodiments, one or more steps in method 820 may be performed before one or more steps in method 810.

At step 821, the scale 50 and the pad 30 are mounted on the base 10. In some embodiments, an operator may mount the scale 50 to the base 10 by inserting the mounting portion 52 of the scale 50 into any one of the profiled through holes 117 of the base 10. When the scale 50 is mounted on the base 10, the bottom surface 53 of the mounting portion 52 of the scale 50 may contact the pressure measuring device 70 below the base 10. After or before mounting the scale 50, an operator may mount the spacer 30 to the base 10 by a hole-post mating arrangement between two stop holes 32 on the bottom surface of the spacer 30 and two stop posts 115 on the upper surface 11 of the base 10. The state in which the scale 50 and the pad 30 are mounted on the base 10 can be as shown in fig. 9. Next, the method 820 may proceed to step 822.

At step 822, it is determined whether the top surface 31 of the pad 30 is at the target location. When both the pad 30 and the scale 50 are mounted to the base 10 (as shown in fig. 9), the operator can determine whether the top surface 31 of the pad 30 is at the target position. For example, the operator may observe whether the top surface 31 of the spacer 30 is aligned with the target scale T on the scale 50. Each scale on scale 50 may represent the distance of the corresponding scale line from tibial plateau 91. Thus, based on the flexion-extension gap equality principle described above, the target scale T can be calculated as follows:

T＝G1–G2，

where G1 represents the gap between the femoral plateau 95 and the tibial plateau 91 in the knee-joint straightened state, and G2 represents the distance between the upper edge of the femoral posterior condyle osteotomy groove 61 of the osteotomy plate 60 and the bottom surface 62 of the osteotomy plate 60. It will be appreciated that when the top surface 31 of the spacer 30 is aligned with the target graduation T on the scale 50, the bottom surface 62 of the osteotomy plate 60 is also aligned with the target graduation T. Thus, the distance from the upper edge of the posterior femoral condyle osteotomy groove 61 to the tibial plateau 91 is g2+t. According to the calculation formula of the target scale T, the gap (g2+t) between the posterior condyle after the resection of the femoral posterior condyle and the tibial plateau will be equal to the gap (G1) between the femoral plateau 95 and the tibial plateau 91 in the straightened state of the knee joint, so as to satisfy the principle of equal flexion and extension gaps. When the top surface 31 of the spacer 30 is not aligned with the target scale T on the scale 50, it may be determined that the top surface 31 of the spacer 30 is not positioned at the target location. At this point, method 820 may proceed to step 823.

At step 823, the height of the top surface 31 of the spacer 30 is adjusted. In some embodiments, the operator may utilize the height adjustment mechanism in the osteotomy positioning device 1 described above to adjust the height of the top surface 31 of the spacer 30 such that the top surface 31 of the spacer 30 is aligned with the target graduation T on the scale 50. In some embodiments, the top surface 31 of the spacer 30 may be aligned with the target scale T on the scale 50 by replacing the appropriate spacer 30 or adding a spacer between the spacer 30 and the base 10.

When the top surface 31 of the spacer 30 is aligned with the target scale T on the scale 50, it can be determined that the top surface 31 of the spacer 30 is positioned at the target location. At this point, method 820 may proceed to step 824.

At step 824, osteotomy plate 60 is installed. In some embodiments, after the spacer 30 is adjusted such that its top surface 31 is aligned with the target scale T of the scale 50, the operator may remove the scale 50 from the base 10 and then place the osteotomy plate 60 on the spacer 30 such that the bottom surface 62 of the osteotomy plate 60 contacts and conforms to the top surface 31 of the spacer 30, as shown in figure 10. Fig. 10 is a schematic view showing an operation state of positioning an osteotomy plate 60 using the osteotomy positioning device 1 of the present invention. After placing the osteotomy plate 60 on the spacer 30, the operator may also secure the osteotomy plate 60 to the resected distal femur, i.e., the femoral plateau 95, using the fixation nails 63, thereby securing the position of the osteotomy plate 60. At this time, the distance (g2+t) between the upper edge of the femoral posterior condyle osteotomy groove 61 of the osteotomy plate 60 and the tibial plateau 91 is equal to the gap G1 between the femoral plateau 95 and the tibial plateau 91 in the knee straightened state. Method 820 may proceed to step 825.

At step 825, the method 820 for positioning the osteotomy plate 60 ends.

After the osteotomy plate 60 is secured to the femoral platform 95, the osteotomy positioning device 1 and the pressure measurement device 70 can be removed, leaving only the fixation pegs 63 and osteotomy plate 60, as shown in figure 11. Fig. 11 shows a schematic view of the osteotomy positioning device 1 of the present invention, with the osteotomy plate 60 secured to the femoral platform 95, removed. When the osteotomy plate 60 is secured to the femoral platform 95, the femoral posterior condyles can be osteotomy aligned with the femoral posterior condyle osteotomy groove 61 of the osteotomy plate 60.

While the invention has been described in terms of the preferred embodiments of the present disclosure, it is not intended to be limited thereto but only by the scope set forth in the following claims. It will be appreciated by those skilled in the art that changes and modifications may be made to the embodiments described herein without departing from the invention in its broader spirit and scope as set forth in the appended claims.

Claims

1. An osteotomy positioning device, comprising:

a base, the base having:

an upper surface having a first upper surface area and a second upper surface area, wherein the first upper surface area and the second upper surface area are located on either side of the upper surface; and

A lower surface for mounting to a pressure measurement device; and

at least one first cushion piece which is used for being arranged on the first upper surface area or the second upper surface area of the base so as to position the tension balance position of two side parts of the bone end of the bone joint before osteotomy,

wherein the pressure measuring device is configured to measure the applied pressure when a first side portion or a second side portion of the two side portions of the bone end is pressed against at least one of the at least one first pad, the first upper surface area, and the second upper surface area.

2. The osteotomy positioning device of claim 1, wherein,

the first pad member is a pad member,

a first one of the bone end side portions includes a medial femoral posterior condyle and a second one of the bone end side portions includes a lateral femoral posterior condyle,

the pressure measurement device is configured to be mounted between a tibial plateau and a base of the osteotomy positioning device.

3. The osteotomy positioning device of claim 2, wherein the base has:

a first mounting portion located at the first upper surface region; and

a second mounting portion, said second mounting portion being located in said second upper surface area,

The first pad is configured to have a mounting engagement portion for engaging with the first mounting portion or the second mounting portion of the base to mount the first pad to the first upper surface area or the second upper surface area of the base.

4. The osteotomy positioning device of claim 3, wherein the first and second mounting portions are slots and are spaced apart from the base at opposite side edges.

5. The osteotomy positioning device of claim 4, wherein the first pad has an operative aperture for operatively engaging an auxiliary tool to disengage the mounting engagement portion of the first pad from the clamping slot to remove the first pad from the rim of the base.

6. The osteotomy positioning device of any of claims 2-5, wherein the upper surface of the base further has a third upper surface area, the third upper surface area being closer to a front portion of the upper surface than the first upper surface area and the second upper surface area,

the osteotomy positioning device further includes a second spacer for mounting to the third upper surface area of the base, and a top surface of the second spacer for supporting an osteotomy plate to position an osteotomy position of the osteotomy plate.

7. The osteotomy positioning device of claim 6, wherein the second spacer is a spacer, the bottom surface of the second spacer has at least one retaining hole, and

the base has at least one spacing post located on a third upper surface area of the base,

wherein the spacing post is for cooperating with a spacing hole of the second pad for detachably mounting the second pad to a third upper surface area of the base.

8. The osteotomy positioning device of claim 7, further comprising a height measurement mechanism, the height measurement mechanism comprising:

a shaped through hole located in the third upper surface area of the base;

a scale, comprising:

the tibial plateau comprises a body, a plurality of scales and a plurality of support rods, wherein the body is provided with scales for indicating the distance from the corresponding scale mark to the tibial plateau; and

the third installation part is used for being installed in a matched mode with the special-shaped through hole;

wherein the scale is used to measure the distance of the top surface of the second pad from the tibial plateau.

9. The osteotomy positioning device of claim 7, further comprising a height adjustment mechanism for adjusting a distance between a bottom surface of the pad and an upper surface of the base, the height adjustment mechanism comprising at least:

A stem portion; and

a through hole located in a third upper surface area of the base,

wherein, one end of the pole portion stretches out the upper surface of base through the through-hole and butt is located the bottom surface of the second pad piece above the through-hole, and the distance that the one end of pole portion stretches out the upper surface of base is adjustable.

10. The osteotomy positioning device of claim 9, wherein the stem is a knob having a threaded shaft and the through hole is a threaded hole,

the bottom surface of the second cushion piece is provided with a plurality of limiting holes, and the third upper surface area of the base is provided with a plurality of limiting columns, wherein the limiting columns are symmetrically distributed relative to the threaded holes.

11. The osteotomy positioning device of claim 1, wherein the lower surface of the base is mounted in limited relation to the top surface of the pressure measurement device by a post-alignment structure.

12. The osteotomy positioning device of claim 1, wherein the lower surface of the base has first and second lower surface regions opposite the first and second upper surface regions, respectively, wherein the first and second lower surface regions each have at least one contact portion for contacting a corresponding pressure test portion on the pressure measurement device.