This application claims priority of European Patent Application EP 19 205 231.4 filed on Oct. 25, 2019, which is incorporated by reference herewith.
The invention relates to a leg-holding device and an arrangement method of said device for hip or knee surgery, for instance, in the case of a hip arthroplasty, which allows the leg of a patient to be rotated and held, especially in external rotation.
Generally, wide ranges of positioning devices are utilized in surgical procedures, depending on the nature of the surgery as well as the choice of surgical approach (e.g. posterior, anterior, and lateral). In the case of a hip or knee surgery, distraction units are utilized for positioning the leg and/or the knee of a patient, which are normally attached to a standard operating table and are dedicated to a specific choice of surgical approach. The prior distraction units are either strictly dedicated to the nature of the surgery or of considerable size with complex mechanisms. For the latter case, the distraction units can be stand-alone units or assimilated with the operating table, however they consume a significant amount of resources (e.g., man-power, energy) due to their demanding and complex nature of operation.
For example, the document CN 203885627 U shows an adjustable fixation surgical knee distraction device for holding the knee of a patient at 90 degrees, especially for driving the tension on tibia away from femur. However, the distraction device is dedicated to knee surgery and does not support external rotation on the leg, for instance, for a patient in lateral decubitus position in order to allow holding of leg in hip extension and adduction.
Accordingly, there is a need to provide a leg-holding device for hip or knee surgery and an arrangement method thereof in a lightweight and cost-effective manner, which further supports the lateral decubitus position for hip and/or knee adduction.
According to a first aspect of the invention, a leg-holding device for hip or knee surgery is provided. The device comprises a support fixture adapted to fasten the device on an edge of a surface. In addition, the device comprises a main frame arranged on the support fixture in a detachable manner, adapted to move along a first lateral axis and a first rotational axis with respect to the support fixture. Furthermore, the device comprises a rotating frame arranged on the main frame in a detachable manner, adapted to move along a second lateral axis and a second rotational axis with respect to the main frame. Moreover, the device comprises a foot plate arranged on the rotating frame in a detachable manner, adapted to move along a third lateral axis and a third rotational axis with respect to the rotating frame.
In this context, the first lateral axis and the first rotational axis are parallel to the third lateral axis and the third rotational axis respectively. Moreover, the first and third lateral axes and the first and third rotational axes are perpendicular to the second lateral axis and the second rotational axis respectively.
Therefore, a leg-holding device is provided in a simple and cost-effective manner that facilitates numerous degrees of freedom in order to manipulate the leg position during a surgery. Especially, the frames and the foot plate are formed in a light-weight and detachable manner, which advantageously allows for moving the leg easily and quickly during the surgical procedure, for instance, for externally rotating the leg 90 degrees to each other. Furthermore, the detachable foot plate along the rotating frame as well as the detachable rotating frame along the main frame permit quick detachment and/or reattachment of a leg to the device for easy reduction and/or dislocation.
According to a first preferred implementation form of said first aspect of the invention, the support fixture comprises a first fastening element and a second fastening element, where the first fastening element is adapted to fasten the main frame at a given lateral displacement along the first lateral axis and a given rotational angle along the first rotational axis. In addition, the second fastening element is adapted to fasten the support fixture on the edge of the surface. Advantageously, the main frame resp. the device can be adjusted to a certain height and a certain angle with respect to the surface on which the device is attached, for instance, an edge of an operating table.
According to a second preferred implementation form of said first aspect of the invention, the main frame comprises an L-shaped member having a fixed end and a free end and a hollow cylinder, where the fixed end is attached to a midpoint of the hollow cylinder and the free end is arranged on the support fixture. Herein, the free end and the fixed end can be welded together to formulate the L-shaped member where the free end is preferably displaced by 90 degrees with respect to the fixed end. The fixed end can either be bolted or welded to the hollow cylinder for formulating a T junction at the intersection.
According to a further preferred implementation form of said first aspect of the invention, the rotating frame comprises an L-shaped member having a first end and a second end, where the first end is arranged through the hollow cylinder perpendicular to the fixed end of the main frame. In this context, the first end and the second end can be welded together to form the L-shaped member and the inner diameter of the hollow cylinder is sufficiently large to encompass the first end while allowing the first end resp. the rotating frame to be rotated.
According to a further preferred implementation form of said first aspect of the invention, the hollow cylinder comprises a screw hole opposite to the fixed end of the main frame. In addition, the device further comprises a locking mechanism arranged at the screw hole, adapted to fasten the first end of the rotating frame at a given lateral displacement along the second lateral axis and a given rotational angle along the second rotational axis. Advantageously, the rotating frame can be adjusted to a certain length based on the required distance between the main frame and the foot plate. Moreover, the rotating frame can be adjusted to a certain angle regarding the main frame in order to facilitate 360 degrees rotation of the foot plate along a plane perpendicular to the surface on which the device is attached.
According to a further preferred implementation form of said first aspect of the invention, the foot plate comprises a vertical support plate and a horizontal support plate attached on a surface perpendicular to each other. Advantageously, the support plates allow for convenient placement of a foot on the foot plate and further simplify the attachment of a leg on the device. Moreover, the foot plate offers significant adaptability with regard to different foot size respective to different patients.
According to a further preferred implementation form of said first aspect of the invention, the foot plate further comprises a hollow cylindrical tube attached to the back of the foot plate, adapted to be positioned on the second end of the rotating frame at a given lateral displacement along the third lateral axis and a given rotational angle along the third rotational axis. The cylindrical tube along with the support plates advantageously allow for easy binding of a foot on the foot plate while providing adequate view of the heel and foot for leg length comparison.
Herein, the inertia of the attached leg and the gravity will be enough to position the foot plate on the rotating frame at a certain angle. Additionally or alternately, the cylindrical tube may comprise additional locking arrangement in order to position the foot plate at a certain angle and a certain height on the second end of the rotating frame.
According to a further preferred implementation form of said first aspect of the invention, the main frame further comprises a first frame segment and a second frame segment, each comprising a member having a fixed end and a free end. In this context, the fixed ends of the members are attached to a respective hollow cylinder. Preferably, the first frame segment and the second frame segment are identical in dimensions and shapes, where the fixed end of each member is bolted or welded to a mid-point of a respective hollow cylinder. Advantageously, additional set-up flexibility is incorporated.
According to a further preferred implementation form of said first aspect of the invention, the hollow cylinders of the first frame segment and the second frame segment each comprises a screw hole opposite to the respective fixed ends of the members in order to facilitate the locking mechanism. In this context, the free end of the first frame segment is arranged through the hollow cylinder of the second frame segment perpendicular to the member of the second frame segment and is further fastened by the respective locking mechanism at a given lateral displacement along a fourth lateral axis and a given rotational angle along a fourth rotational axis.
Moreover, the free end of the second frame segment is arranged on the support fixture and is fastened at a given lateral displacement along the first lateral axis and a given rotational angle along the first rotational axis. Advantageously, at least one additional degree of freedom is therefore introduced.
According to a further preferred implementation form of said first aspect of the invention, the support fixture, the main frame, the rotating frame, the foot plate and the locking mechanism are adapted to be sterilized in a compact arrangement. Advantageously, the device can be operated within the sterile field, preferably by the surgeon him/her-self during a medical procedure.
According to a second aspect of the invention, a method for arranging a leg-holder device comprising a support fixture, a main frame, a rotating frame and a foot plate is provided. The method comprises the step of arranging the main frame on the support fixture in a detachable manner so as to move along a first lateral axis and a first rotational axis with respect to the support fixture. The method further comprises the step of arranging the rotating frame on the main frame in a detachable manner so as to move along a second lateral axis and a second rotational axis with respect to the main frame. Moreover, the method comprises the step of arranging the foot plate on the rotating frame in a detachable manner so as to move along a third lateral axis and a third rotational axis with respect to the rotating frame. Advantageously, numerous degrees of freedom are facilitated in a simple and cost-effective manner for rotating and holding the leg during a surgery.
Exemplary embodiments of the invention are now further explained with respect to the drawings by way of example only, and not for limitation. In the drawings:
Reference will now be made in detail to the embodiments of the present invention, examples of which are illustrated in the accompanying drawings. However, the following embodiments of the present invention may be variously modified and the range of the present invention is not limited by the following embodiments.
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It is to be noted that the choice of the surgical approach plays a vital role for selecting an appropriate distraction device. For instance, the posterior approach, which is most commonly used approach among the surgeons, especially in hip surgeries, allows a better and wider visibility and possibility of manipulation of leg position, while allowing less comfort compared to other approaches. On the other hand, in the direct anterior approach patients seemed to have less postoperative pain, however, is associated with higher complication rates and difficult femoral component positioning. An anterior approach on a patient in lateral decubitus, i.e., the anterior approach in side position seems to overcome the complexities of the foregoing approaches, especially allows secure component positioning as well as leg length comparison. The device 100 is not only adapted to the direct anterior approach but also for patients in lateral decubitus due to the linear and rotational movements of the separable sections, which advantageously facilitate six degrees of freedom of operation.
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Furthermore, the moving section 17 and the fixed section 19 are attached to each other on a channel 18, via which the moving section 17 is able to rotate along a plane perpendicular to the axis X of the fastening plane. Therefore, the support fixture 10 additionally allows the device 100 to be rotated along the edge of the operating table and thereby configures the device 100 to be adapted for different leg placement distances, for instance, for different heights of patients.
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The dimensions of the main frame 20 is kept to a minimum in order to facilitate a compact arrangement. For instance, the length or height LMF of the main frame 20, i.e., the longitudinal distance between the edge of the free end 23 to the T-joint can be 350 mm. The length LMF of the main frame 20 primarily controls the effective height of the device 100 along which the height of the device 100 can be adjusted with respect to the fastening edge of the operating table. The width or displacement WMF of the main frame 20, i.e., the lateral distance between the free end 23 and the T-joint can be 150 mm. The diameter DMF of the L-shaped member 21 i.e., the thickness of the tube can be 16 mm. Furthermore, the outer diameter Dcylinder of the hollow cylinder 24 can be 40 mm while the inner diameter Dhollow or the diameter of the conduit 25 can be 16 mm. The screw hole 26 may comprise a diameter Dhole of 8 mm.
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For instance, the height or length LRF of the rotating frame 30, i.e., the longitudinal distance between the first end 32 and the second end 33 can be 150 mm. Similarly, the width WRF of the rotating frame 30, i.e., the lateral distance between the first end 32 and the second end 33 can be 150 mm. In this context, the width WRF of the rotating frame 30 principally controls the effective positioning of the device 100 along which the distance of the device 100 can be adjusted with respect to the position of a foot of a patient. The tubular L-shaped member 31 may comprise a diameter DRF of 16 mm, symmetrical to the inner diameter of the hollow cylinder 24 of the main frame 20. In addition, a portion of the first end 32 can be threaded with roots and crests in order to provide better fastening along the length of the hollow cylinder 24.
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During a medical procedure, a patient's foot is firmly placed on the foot plate 40 with additional paddings inserted in-between the foot and the foot plate 40. Additionally, the foot is bound to the foot plate 40, for instance, via bandage wrapped around both the foot and foot plate 40 for rigidity. Since the wrapping only covers along the tube 44, an adequate view of the heel and the foot are available in order to compare the leg lengths. Furthermore, the detachment/reattachment motion of the foot plate 40, especially along the second end 33 of the rotating frame 30, is conveyed along the interior of the tube 44. Hence, the wrapping or paddings do not interfere with the motion of the foot plate 40 when a foot is detached from or reattached to the device 100.
The width Wbase of the vertical support plate 42 as well as the horizontal support plate 43 can be approximately 30 mm. The length Ltube of the hollow cylindrical tube 44 corresponds to the length or height of the rotating frame 30, i.e., 150 mm. In order to facilitate easy detachment or reattachment of the foot plate 40 on the second end 33 of the rotating frame 30, the diameter Dtube of the tube 44 is slightly greater than the diameter of the rotating frame 30, for instance, approximately 18 mm.
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The sliding nature of the handle 52 provides additional flexibility in the fastening operation since the bolt 51 can be rotated from both sides. The diameter of the threaded portion 54 of the bolt 51 corresponds to the diameter of the screw hole 26 on the hollow cylinder 24 of the main frame 20. The diameter Dbolt of the cylindrical head 53 of the bolt 51 is preferably larger than the diameter Dhole of the threaded portion 54, for instance, about 15 mm, in order to support the threaded portion 54 along the screw hole 26, especially on the outer surface of the hollow cylinder 24.
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Thus, the hollow cylinder 67 of the first frame segment 61 comprises a screw hole 69 threaded on the opposite side of the fixed end 63. Likewise, the hollow cylinder 68 of the second frame segment 62 comprises a screw hole 70 threaded on the opposite side of the fixed end 65. The screw holes 69,70 are preferably symmetrical to the screw hole 26 on the hollow cylinder 24 of the main frame 20 illustrated in
On the other hand, the hollow cylinder 68 of the second frame segment 62 encompasses the free end 64 of the first frame segment 61 such that the first frame segment 61 is able to move along its length, especially perpendicular to the second frame segment 62. Furthermore, the first frame segment 61 is able to rotate along the hollow cylinder 68 of the second frame segment 62. A further locking mechanism 50 is attached to the hollow cylinder 68 of the second frame segment 62 via the screw hole 70 in order to fix the first frame segment 61 at a certain length and a certain angle.
As an alternative to the use of locking mechanism 50 on the second frame segment 62, the free end 64 of the first frame segment 61 may be extensively threaded and may be attached to the second frame segment 62 through the hollow cylinder 68. In this case, the first frame segment 61 can be adjusted by means of a detachable nut, placed along any side of the hollow cylinder 68, with threaded hole symmetrical to the threading of the free end 64 of the first frame segment 61. As a result, by applying external rotation on the nut, an adjustment on the length as well as the angular position of the first frame segment 61 can be achieved with respect to the second frame segment 62.
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The locking mechanism 50 that is arranged at the screw hole 70 of the hollow cylinder 68 fixes the first frame segment 61 at a certain lateral displacement and a certain rotational angle with respect to the second frame segment 62. The hollow cylinder 67 of the first frame segment 61 allows the first end 32 of the rotating frame 30 to move laterally as well as rotationally within the conduit. An additional locking mechanism 50 (not shown) fixes the first end 32 resp. the rotating frame 30 at a certain linear displacement and a certain rotational angle.
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The rotating frame 30 can be moved linearly along the second lateral axis 3, which allows for an easy adjustment for the effective placement of the device 200, for instance, in order to adapt with different patients heights. The rotating frame 30 is further able to rotate along the second rotating axis 4 that facilitates the rotation of the foot plate 40 by 360 degrees. In addition, the foot plate 40 is able to move linearly along the third lateral axis 5 and is further able to rotate along the third rotational axis. This especially allows for easy detachment/reattachment of a foot on the foot plate 40 resp. on the device 200 and an easy positioning of a foot on the foot plate 40.
Moreover, the first frame segment 61 of the main frame 60 is able to move linearly along the fourth lateral axis 7 and is further able to rotate along the fourth rotational axis 8. Hence, two additional degrees of freedom are introduced, especially respect to the movement of the rotating frame 30 resp. the movement of the foot plate 40. In this context, the fourth lateral axis 7 is perpendicular to the first lateral axis 1, the second lateral axis 3 and the third lateral axis 5. Likewise, the fourth rotational axis 8 is perpendicular to the first rotational axis 2, the second rotational axis 4 and the third rotational axis 6.
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Advantageously, tightening the nut 84 pulls the first end 82 of the rotating frame 80 through the conduit of the hollow cylinder 24 before the rotating frame 80 is externally rotated and then locked at a specific angle via the locking mechanism 50. This result in an application of traction to the leg attached to the foot plate 40. Preferably, the shape and dimensions of the rotating frame 80 are identical to the rotating frame 30. The nut 84 has an outer diameter Dnut slightly smaller than the diameter Dcylinder of the hollow cylinder 24, for instance, around 35 mm. Preferably, the nut 84 is substantially thick, for instance, having a thickness Tnut of about 20 mm, which allows for convenient external handling of the nut. A simple T-handle socket wrench can be used in order to handle the nut 84 externally.
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While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein without departing from the spirit or scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above described embodiments. Rather, the scope of the invention should be defined in accordance with the following claims and their equivalents.
Although the invention has been illustrated and described with respect to one or more implementations, equivalent alterations and modifications will occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In addition, while a particular feature of the invention may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application.
Number | Date | Country | Kind |
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19205231.4 | Oct 2019 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/079473 | 10/20/2020 | WO |