WO2021111907A1 - 骨手術用器具 - Google Patents

骨手術用器具 Download PDF

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Publication number
WO2021111907A1
WO2021111907A1 PCT/JP2020/043425 JP2020043425W WO2021111907A1 WO 2021111907 A1 WO2021111907 A1 WO 2021111907A1 JP 2020043425 W JP2020043425 W JP 2020043425W WO 2021111907 A1 WO2021111907 A1 WO 2021111907A1
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WO
WIPO (PCT)
Prior art keywords
bone
axis
slit
guide
osteotomy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/043425
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English (en)
French (fr)
Japanese (ja)
Inventor
武徳 秋山
靖治 横山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Osferionbiomaterials Corp
Original Assignee
Olympus Terumo Biomaterials Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Olympus Terumo Biomaterials Corp filed Critical Olympus Terumo Biomaterials Corp
Priority to JP2021562571A priority Critical patent/JP7309911B2/ja
Priority to CN202080083395.XA priority patent/CN114760937B/zh
Priority to EP20897311.5A priority patent/EP4070741A4/en
Priority to TW109141515A priority patent/TWI769597B/zh
Publication of WO2021111907A1 publication Critical patent/WO2021111907A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A61B17/15—Guides therefor
    • A61B17/151—Guides therefor for corrective osteotomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/564—Methods for bone or joint treatment
    • A61B2017/565—Methods for bone or joint treatment for surgical correction of axial deviation, e.g. hallux valgus or genu valgus

Definitions

  • the present invention relates to an instrument for bone surgery, and more particularly to an instrument used as a guide for guiding an osteotomy blade in osteotomy.
  • HTO high tibial osteotomy
  • DTO medial open subsurface osteotomy
  • OA patellofemoral joint
  • PF patellofemoral joint
  • DTO does not change the position of patella C before and after surgery. Therefore, compared with HTO, DTO has an advantage that PFOA associated with low tibial osteotomy C is less likely to progress after surgery.
  • postoperative bone instability due to the epiphysis of tibia A being pulled by the patellar tendon D and the accompanying delay in bone union have become issues for DTO.
  • tibial osteotomy As another method of tibial osteotomy, a method of cutting the tibia in an arc shape has been proposed (see, for example, Non-Patent Document 1).
  • the arc-shaped osteotomy increases the contact area of the osteotomy, which can be expected to accelerate bone union.
  • DTAO Dermatal Tibia Tuberosity Arc Osteotomy
  • DTAO uses the rough surface so that the continuity between the epiphysis and the diaphysis of the tibia is maintained. Cut the distal part halfway in the anterior-posterior direction.
  • Kenichi Tagaya 3 outsiders, "Usefulness of Citieffe arch flea for bone fusion in high tibial osteotomy", Journal of the Chinese Society of Shikoku Orthopedic Surgery, Chinese Society of Shikoku Orthopedic Surgery, April 15, 2000, No. Volume 12, Issue 1, p.111-116
  • Non-Patent Document 1 One of the problems with the method of Non-Patent Document 1 is that the operation of osteotomy is very complicated.
  • the tibia is cut into an arc shape with an arch chisel while hitting an arch chisel with a hammer.
  • it is difficult to accurately cut the rough surface along the arcuate line because the cortical bone under the rough surface is hard, and the arch flea is cut.
  • the load of hitting is applied to the bone, making it difficult to maintain bone continuity.
  • the cut surface of the rough surface is uneven, the contact area becomes small, or uneven load is applied to the bone by forcibly contacting the cut surface with the adjacent bone surface, resulting in bone instability. May increase.
  • the present invention has been made in view of the above circumstances, and an object of the present invention is to provide a highly versatile bone surgical instrument capable of accurately and easily performing an arcuate osteotomy.
  • One aspect of the present invention is a bone surgical instrument that guides the osteotomy blade in the circumferential direction around a specific point of the bone, the central portion positioned at the specific point, and the circumference around the axis passing through the central portion.
  • a bone surgical instrument including a guide portion and a fixing portion fixed to the bone using a fixing member.
  • the central part is positioned at a specific point of the bone
  • the guide part is placed on the bone so that the slit is located at the position where the bone should be cut, and the bone surgical instrument does not move with respect to the bone.
  • the slit extends in the circumferential direction around a specific point. Therefore, by advancing the osteotomy with the osteotomy blade while moving the osteotomy blade according to the guidance by the slit, it is possible to accurately and easily perform the arc-shaped or substantially arc-shaped osteotomy. Further, since the bone surgical instrument can be combined with various osteotomy blades thinner than the width of the slit, it is possible to provide a highly versatile bone surgical instrument.
  • a bone surgical instrument may be used to cut the distal portion of the rough surface of the tibia into an arc or a substantially arc. That is, by positioning the central part at the epiphysis of the tibia, the distal part of the rough surface can be accurately and easily boned along an arc-shaped or substantially arc-shaped line centered on the hinge point. Can be cut.
  • the guide portion may have a thickness such that the amount of protrusion of the tip of the osteotomy blade from the slit is equal to or less than a predetermined amount.
  • the amount of protrusion of the tip of the osteotomy blade from the slit of the cutting edge is limited by the thickness of the guide portion. According to the above configuration, by limiting the amount of protrusion of the cutting edge from the slit to a predetermined amount or less, it is possible to prevent excessive osteotomy in the direction parallel to the axis line.
  • the central portion may have a pin hole penetrating the central portion in a direction parallel to the axis.
  • a pin that serves as a reference for position and orientation may be inserted at a specific point on the bone.
  • the central portion is positioned at a specific point by the pin passing through the pin hole, and the depth direction of the slit is parallel to the direction of the longitudinal axis of the pin. Therefore, an osteotomy surface parallel to the longitudinal axis of the pin can be formed.
  • the fixing portion may be provided on the side opposite to the central portion with respect to the guide portion. According to this configuration, when the bone surgical instrument is placed on the bone and the cutting instrument cuts the bone along the surface intersecting the axis passing through the center, the interference with the fixing member of the cutting instrument is prevented. Can be done.
  • the width of the slit may be 0.5 mm to 1.5 mm larger than the thickness of the osteotomy blade. According to this configuration, an appropriate spatial margin is formed inside the slit when the osteotomy blade is inserted into the slit. As a result, it is possible to prevent the bone cutting blade from interfering with the inner surface of the slit while reducing the blurring of the bone cutting blade during cutting.
  • the outer shape of the guide portion is similar to or substantially similar to the shape of the slit, and the wall thickness of the edge portion of the guide portion surrounding the slit is increased. It may be 1 mm to 5 mm. According to this configuration, the position of the slit can be accurately grasped from the image of the guide portion under fluoroscopy. Therefore, in osteotomy in which the bone is cut to the position of the slit along the surface intersecting the axis passing through the central portion, it is possible to prevent excessive bone cutting beyond the position of the slit.
  • a contact surface that comes into contact with the surface of the bone may be provided on one side in the direction along the axis, and the contact surface may be a concave surface that matches the shape of the surface of the bone.
  • the surface of the bone on which the bone surgical instruments are placed is a convex curved surface.
  • the support portion for connecting the central portion and the guide portion to each other is provided, and the support portion intersects the axis between the central portion and the center of the guide portion in the circumferential direction. It may extend in the direction.
  • the bone surgical instrument has a substantially T-shape symmetrical with respect to the strut portion in a plan view in a direction along the axis passing through the central portion. With such a shape, it is possible to prevent the bone surgical instrument arranged on the bone from tilting, and it is possible to arrange the bone surgical instrument more stably with respect to the bone.
  • the slit may extend along an arc having a constant radius of curvature.
  • a gap corresponding to the thickness of the osteotomy blade is formed along the arc-shaped osteotomy line.
  • the distance between the specific point and the osteotomy line is the same over the entire length of the osteotomy line. Therefore, the bone fragment containing the specific point can be rotated around the specific point while maintaining the width of the void constant. That is, the bone fragments can be easily rotated without the two bone surfaces facing each other across the gap interfering with each other during rotation.
  • the slit may extend along a curve in which the radius of curvature gradually decreases in the circumferential direction around the axis.
  • the distance between the central portion and the slit gradually decreases in the circumferential direction from one end to the other end of the slit, so that the distance between the specific point and the osteotomy line is also the osteotomy line. Gradually decreases from one end to the other end. Therefore, as the bone fragment containing the specific point is rotated around the specific point, the void gradually becomes narrower. This makes it possible to reduce the compression and deformation of the bone required to bring the two opposing bone surfaces into contact with each other across the gap after the bone is corrected by the rotation of the bone fragments.
  • the slit is composed of a plurality of straight lines that are continuous with each other in the circumferential direction around the axis, and each of the plurality of straight lines is in the tangential direction or the substantially tangential direction of the circumference centered on the axis. May extend to. According to this configuration, even a type of osteotomy blade that can move on a parallel plane can be easily guided by a slit.
  • the triangles having both ends of each straight line portion and the central portion as the apex are right triangles having the straight line portion as the base, and the opposite side of one right triangle and the other adjacent to the one right triangle. It may be common with the diagonal side of one right triangle. According to this configuration, it is possible to easily design the shape of a slit composed of a plurality of straight lines and gradually shortening the radius of curvature by using a plurality of right triangles arranged continuously in the circumferential direction around the center.
  • the distance between the central portion and the slit may be shortened by a predetermined length each time the distance is displaced by a predetermined angle in the circumferential direction around the axis.
  • the gap is narrowed by a predetermined length. Therefore, by designing a predetermined angle and a predetermined length according to the thickness of the osteotomy blade and the correction angle of the bone fragment including a specific point, it is easy to obtain the desired width of the gap after rotation. Can be designed to.
  • the distance between the central portion and the slit may be 45 mm to 65 mm. According to this configuration, it is possible to prevent the arc-shaped or substantially arc-shaped osteotomy line from interfering with the patellar tendon in the osteotomy of the distal portion of the rough surface portion. In addition, it is possible to secure a sufficient area for the osteotomy portion of the rough surface portion located proximal to the osteotomy line, and the bone screw for fixing the osteotomy portion can be easily inserted into the osteotomy portion. be able to.
  • a movable portion that is movably connected to the guide portion in the circumferential direction around the axis is provided, and the movable portion penetrates in a direction parallel to the radial direction orthogonal to the axis and faces the axis.
  • the guide wire or the guide hole for guiding the guide sleeve into which the guide wire is inserted is provided, and the outer peripheral surface of the guide wire penetrating the guide hole is in an offset direction orthogonal to the axis and the central axis of the guide hole. It may be arranged at a position away from the axis.
  • the movable portion may include a second guide portion that guides the osteotomy blade along a plane orthogonal to the axis.
  • FIG. 1A It is a side view of the bone surgery instrument of FIG. 1A. It is a figure explaining the procedure of DTAO using the bone surgical instrument of FIG. 1A and FIG. 1B. It is a figure explaining the procedure of DTAO using the bone surgical instrument of FIG. 1A and FIG. 1B. It is a figure explaining the procedure of DTAO using the bone surgical instrument of FIG. 1A and FIG. 1B. It is a figure explaining the procedure of DTAO using the bone surgical instrument of FIG. 1A and FIG. 1B. It is a perspective view of one modification of the bone surgery instrument of FIG. It is a top view of another modification of the bone surgery instrument of FIG. It is a figure explaining HTO and DTO. It is a top view of the bone surgery instrument which concerns on other embodiment of this invention.
  • FIG. 8A It is a side view of the bone surgery instrument of FIG. 8A seen in the direction along the central axis of the guide hole. It is a perspective view of the bone surgery instrument of FIG. 8A which shows an example of the connection structure which connects a movable part with a guide part. It is a top view of the bone surgery instrument which concerns on other embodiment of this invention.
  • 9 is a perspective view of an example of a second portion of a movable portion in the bone surgical instrument of FIG. 9A.
  • 9 is a perspective view of another example of the second portion of the movable portion in the bone surgical instrument of FIG. 9A.
  • 9 is a perspective view of another example of the second portion of the movable portion in the bone surgical instrument of FIG. 9A.
  • the bone surgical instrument 1 is used for osteotomy in which a bone is cut along an arc-shaped or substantially arc-shaped line extending in the circumferential direction around a specific point of the bone.
  • DTAO Dermatal Tibia Tuberosity Arc Osteotomy
  • the bone surgical instrument 1 can be used not only for DTAO but also for any other osteotomy.
  • the DTAO is a medial dilatation type in that the distal portion of the rough surface portion B is osteotomized along an arc-shaped or substantially arc-shaped line centered on the hinge point H at the dilation.
  • FIG. 4 shows a state after correction by rotating a mass of the epiphyseal portion A1 and the osteotomy portion of the rough surface portion B around the hinge point H.
  • the posterior portion of the rough surface portion B is osteotomy parallel to the tibial axis, and the distal portion of the rough surface portion B is osteotomy perpendicular to the tibial axis.
  • a lower surface E behind the rough surface portion B and a side surface F at the distal portion of the rough surface portion B are formed as the osteotomy surface.
  • the osteotomy of the distal portion of the rough surface portion B is performed along an arc-shaped or substantially arc-shaped line centered on the hinge point H, and the side surface F makes the hinge point H in the anterior-posterior direction of the tibia A.
  • the tibia A is osteotomy from the inside of the tibia A toward the hinge point H, and the osteotomy line L is formed.
  • the right side of the tibia A is the medial side
  • the left side of the tibia A is the lateral side
  • the direction perpendicular to the paper surface is the anterior-posterior direction.
  • a mass of the epiphysis A1 and the osteotomy portion of the rough surface portion B is rotated around the hinge point H by a correction angle ⁇ to open the osteotomy line L, and the deformation of the tibia A is corrected.
  • the side surface F slides along the concave surface G of the diaphysis A2.
  • the artificial bone or autologous bone is then transplanted into the open area.
  • the osteotomy portion of the rough surface portion B is fixed to the posterior bone A2 with a bone screw or the like. Will be done.
  • DTAO is superior in that it enhances bone stability and enables early bone fusion and fixation strength of the osteotomy.
  • the bone surgical instrument 1 is a guide device that guides the osteotomy blade used for forming the side surface F along an arc-shaped or substantially arc-shaped line.
  • the bone surgical instrument 1 includes a central portion 2, a guide portion 3 having a slit 4, a strut portion 5 that interconnects the central portion 2 and the guide portion 3, and a support portion 5. It includes a fixation portion 6 that is fixed to the tibia A using a fixation member.
  • FIG. 1A is a plan view of the bone surgical instrument 1 viewed in a direction along a predetermined axis I passing through the central portion 2
  • FIG. 1B is a side view of the bone surgical instrument 1 of FIG. 1A as viewed from the right side. is there.
  • the central portion 2, the guide portion 3, the strut portion 5 and the fixing portion 6 are all integrally formed, and therefore, the bone surgical instrument 1 is composed of a single member.
  • the bone surgical instrument 1 is preferably formed of stainless steel, titanium or a titanium alloy in consideration of wear with the cutting instrument.
  • the central portion 2 is a portion positioned at the hinge point (specific point) H of the tibia A, and has a pin hole 2a penetrating the central portion 2 in a direction parallel to the axis I.
  • the hinge pin P1 is inserted at the hinge point H in the anterior-posterior direction of the tibia A.
  • the pin hole 2a is coaxial with or substantially coaxial with the axis I, and has an inner diameter slightly larger than the outer diameter of the hinge pin P1.
  • the guide portion 3 has an arc shape that extends in the circumferential direction around the axis I and has a constant radius of curvature over the entire length.
  • the slit 4 has an arc shape extending in the circumferential direction around the axis I and having a constant radius of curvature over the entire length. Therefore, the outer shape of the guide portion 3 is similar to or substantially similar to the shape of the slit 4 in a plan view seen in the direction along the axis I.
  • the slit 4 penetrates the guide portion 3 in a direction parallel to the axis I.
  • the thickness t of the guide portion 3 in the direction parallel to the axis I is smaller than the length of the osteotomy blade, and the cutting edge of the osteotomy blade penetrating the slit 4 protrudes from the slit 4.
  • the wall thickness d of the edge portion of the guide portion 3 surrounding the slit 4 is substantially uniform over the entire circumference.
  • the wall thickness d is preferably 1 mm to 5 mm from the viewpoint of the slim structure of the guide portion 3 and the visibility of the guide portion 3 in the fluoroscopic image.
  • the distance r between the center portion 2 and the slit 4 in the radial direction orthogonal to the axis I, that is, the radius of curvature of the slit 4 is preferably 45 mm to 65 mm.
  • the distance r corresponds to the distance between the hinge point H and the side surface F.
  • the osteotomy line of the side surface F approaches the diaphysis and the cortical bone becomes large, which makes osteotomy difficult.
  • the distance from the hinge point H to the distal portion of the rough surface portion B on which the side surface F should be formed varies from patient to patient. Therefore, it is preferable that a plurality of sizes of bone surgical instruments 1 having different distances r are prepared so that an appropriate size of the bone surgical instrument 1 can be selected for each patient.
  • the strut portion 5 extends linearly in the radial direction orthogonal to the axis I between the central portion 2 and the center in the circumferential direction of the guide portion 3. Therefore, in a plan view in the direction along the axis I, the bone surgical instrument 1 has a substantially T-shape symmetrical with respect to the support column 5.
  • the fixing portion 6 has a fixing hole 6a that penetrates the fixing portion 6 in a direction parallel to the axis I.
  • the fixing portion 6 is located on the side opposite to the central portion 2 with respect to the guide portion 3, and in the case of the bone surgery instrument 1 of FIG. 1A, the fixing portion 6 is located on an extension line of the strut portion 5.
  • One or more fixing holes 5a similar to the fixing holes 6a may be provided in the strut portion 5 so that the operator can change or select the fixing position of the bone surgical instrument 1 by the fixing pin P2. ..
  • the strut portion 5 has seven fixing holes 5a arranged so as to be spaced apart from each other in the longitudinal direction of the strut portion 5. When a plurality of fixing holes 5a are arranged at equal intervals, the plurality of fixing holes 5a can be used as a scale.
  • the central portion 2 is positioned at the hinge point H and the bone surgical instrument 1 is placed on the tibia A, it is smaller and more appropriate based on the positional relationship between the distal portion of the rough surface portion B and the plurality of fixing holes 5a.
  • a different size of bone surgical instrument 1 can be selected.
  • the dimensions of the guide portion 3 and the slit 4 are designed according to the dimensions of the osteotomy blade used to form the side surface F.
  • the osteotomy blade is a common osteotomy blade, such as a thin saw blade.
  • the thickness t of the guide portion 3 is designed according to the length of the osteotomy blade so that the amount of protrusion of the tip of the osteotomy blade from the slit 4 is equal to or less than a predetermined amount.
  • the thickness t is preferably 5 mm to 25 mm larger than the length of the osteotomy blade.
  • the width w of the slit 4 in the radial direction orthogonal to the axis I is only 0.5 mm to 1.5 mm thicker than the thickness of the osteotomy blade in order to prevent rattling of the osteotomy blade in the slit 4. Larger is preferred.
  • the osteotomy blade has a thickness of 0.3 mm to 0.8 mm, a width of 5 mm to 15 mm, and a length of about 15 mm to 45 mm. If the thickness and width of the osteotomy blade are too large, the amount of bone cut will increase. As a result, a large compression force is required to bring the cut surface into contact with the adjacent bone surface, and the load applied to the bone increases. Further, if the width of the osteotomy blade is too large, it becomes difficult to cut the osteotomy into a complicated shape. If the length of the osteotomy blade is too large, the osteotomy blade tends to bend due to the load during bone cutting, and if the length of the osteotomy blade is too small, the bone cannot be cut to a sufficient depth.
  • the thickness t of the guide portion 3 is preferably 10 mm to 25 mm in order to secure the guide property of the osteotomy blade by the guide portion 3 and the cutting amount of the bone.
  • the width w of the slit 4 is preferably 1 mm to 2 mm.
  • the bone surgical instrument 1 of FIGS. 1A and 1B has a constant thickness as a whole, but the central portion 2, the guide portion 3, the strut portion 5 and the fixing portion 6 have different thicknesses from each other. May be good.
  • a guide wire GW and a hinge pin P1 are inserted into the tibia A in preparation for osteotomy.
  • the guide wire GW is inserted into the tibia A from the medial side toward the hinge point H.
  • the hinge point H is set near the lateral edge of the tibia A.
  • Two guide wires GW arranged in the anterior-posterior direction of the tibia A may be inserted into the tibia A in parallel with each other.
  • the hinge pin P1 is inserted into the hinge point H in the anteroposterior direction of the tibia A.
  • the bone surgical instrument 1 is placed on the tibia A.
  • the central portion 2 is positioned at the hinge point H by passing the hinge pin P1 through the pin hole 2a, and it is confirmed that the slit 4 is located at the distal portion of the rough surface portion B.
  • the size of the bone surgical instrument 1 is changed so that the slit 4 is located at the distal portion of the rough surface portion B.
  • the fixing portion 6 is fixed to the tibia A by inserting the fixing pin P2 into the tibia A in the anteroposterior direction via the fixing hole 6a.
  • a bone saw is inserted into the tibia A from the inside, and the posterior part of the rough surface B is cut parallel to the tibia axis.
  • the region between the hatched guide wire GW and the guide portion 3 is the region where the bone is cut.
  • a lower surface E is formed between the guide wire GW and the guide portion 3 as the first osteotomy surface.
  • an electric or pneumatic bone saw may be used.
  • the osteotomy of the lower surface E is performed while observing the guide wire GW, the bone surgical instrument 1 and the bone saw in the X-ray fluoroscopic image of the tibia A in the anterior-posterior direction. That is, the operator can perform osteotomy by using the guide wire GW and the guide portion 3 as a mark of the boundary of the range to be osteotomized.
  • the outer shape of the guide portion 3 is similar to or substantially similar to the slit 4, the operator can accurately grasp the position of the slit 4 from the outer shape of the guide portion 3. Therefore, it is possible to prevent excessive bone cutting beyond the side surface F formed after this.
  • the fixing portion 6 is located on the opposite side of the central portion 2 with respect to the guide portion 3. Therefore, it is possible to prevent the osteosaw from interfering with the fixing pin P2 passing through the fixing hole 6a when cutting the bone behind the rough surface portion B.
  • the distal portion of the rough surface portion B is osteocut in the anterior-posterior direction. That is, the osteotomy blade is inserted into the slit 4, and the rough surface portion B is osteotomized while moving the osteotomy blade in the circumferential direction in the slit 4.
  • a side surface F is formed at the distal portion of the rough surface portion B as the second osteotomy surface.
  • the side surface F is a convex surface curved in an arc shape around the longitudinal axis of the hinge pin P1.
  • a gap having a width corresponding to the thickness of the osteotomy blade is formed between the side surface F of the rough surface portion B and the concave surface G of the epiphyseal portion A1.
  • the tibia A is osteotomized from the medial side to the lateral side along the guide wire GW.
  • a third osteotomy surface is formed along the osteotomy line L.
  • the bone surgical instrument 1 is removed from the tibia A, and a mass of the epiphyseal portion A1 and the osteotomy portion of the rough surface portion B is placed around the hinge point H with respect to the diaphyseal portion A2. Rotate by the correction angle ⁇ . As a result, the alignment of the tibia A is corrected, and the load applied to the tibia A shifts from the medial side to the lateral side. Since the slit 4 has a constant radius of curvature, the side surface F and the concave surface G are curved surfaces having a constant radius of curvature centered on the hinge point H.
  • the width of the gap is maintained constant regardless of the rotation angle around the hinge point H of the osteotomy portion. That is, the side surface F slides along the concave surface G while always maintaining a constant distance from the concave surface G, and interference with the concave surface G of the side surface F is prevented. Thereby, the osteotomy portion can be easily rotated around the hinge point H.
  • osteotomy portion is fixed to the posterior bone with a bone screw or the like while the lower surface E and the side surface F are brought into contact with the adjacent bone surface by applying pressure to the osteotomy portion in the anterior-posterior direction and in the direction along the tibial axis. To do.
  • the osteotomy blade in the osteotomy of the distal portion of the rough surface portion B, the osteotomy blade is guided by the arc-shaped slit 4 whose center is positioned at the hinge point H. Therefore, the rough surface portion B can be accurately and easily osteotomized in an arc shape centered on the hinge point H. Further, the bone surgical instrument 1 can be combined with various osteotomy blades having a thickness smaller than the width w of the slit 4, and can provide a highly versatile bone surgical instrument 1.
  • the osteotomy is performed without applying an excessive load to the tibia A and in a state where the central portion 2 which is the rotation center of the osteotomy blade is aligned with the hinge point H. Can be done.
  • the contact surface of the bone surgical instrument 1 with the surface of the tibia A may be a flat surface as shown in FIG. 1B, but as shown in FIG. 5, the surface of the tibia A may be a flat surface. It may be a concave surface (contact surface) 7 that matches the shape.
  • the fixing portion 6 is provided at the connecting portion between the guide portion 3 and the strut portion 5.
  • the concave surface 7 is formed on the end surface of the bone surgery instrument 10 on one side in the direction along the axis I, for example, on the end surface of the guide portion 3.
  • the anterior surface of the tibia A on which the bone surgical instrument 10 is placed is a convex curved surface.
  • the slit 4 extends along an arc having a constant radius of curvature, but instead, the slit 4 has a radius of curvature, that is, the distance r gradually decreases from one end to the other. It may extend along a curve. Further, in the present embodiment, the slit 4 is smoothly curved over the entire length, but instead, as shown in FIGS. 5 and 6, they are continuous with each other in the circumferential direction and are centered on the axis I. It may be composed of a plurality of straight line portions 4a extending in the tangential direction or the substantially tangential direction of the circumference.
  • the slit 4 is composed of a plurality of straight portions 4a, and the distance r between the central portion 2 and the slit 4 is gradually shortened from one end to the other end of the slit 4. There is.
  • one end of the slit 4 is arranged outside the tibia A, and the other end of the slit 4 is arranged inside the tibia A.
  • the triangle having both ends and the center portion 2 of each straight line portion 4a as vertices may be a right triangle having the straight line portion 4a as the base.
  • Each right triangle has a hypotenuse and a base and opposite side that sandwich the right angle, and the hypotenuse and opposite side extend radially from the axis I.
  • the opposite side of one right triangle and the hypotenuse of another right triangle adjacent to one right triangle are common and have the same length. Therefore, the slit 4 is formed from the bases of a plurality of right triangles that are continuously arranged around the axis I. Since the length L1 of the opposite side of each right triangle is smaller than the length L2 of the hypotenuse, the length of the side of the right triangle, that is, the distance r gradually becomes shorter from the left side to the right side in FIG.
  • osteotomy surfaces F and G are formed in which the distance from the hinge point H gradually decreases from the outside to the inside of the tibia A. Therefore, as the osteotomy portion rotates inward during correction, the gap between the side surface F and the concave surface G becomes narrower. That is, at the initial stage of rotation, since there is a gap having a sufficient width between the side surface F and the concave surface G, the osteotomy portion can be rotated without interfering with the concave surface G. Further, since the gap is narrowed at the end of rotation, the compression and deformation of the osteotomy portion required to bring the side surface F into contact with the concave surface G can be reduced, and the burden on the tibia A can be reduced.
  • the width of the void after correction becomes uniform over the entire length. Therefore, the side surface F and the concave surface G can be uniformly brought into contact with each other by the compression in the direction along the tibia axis, and it is possible to prevent the load from being partially concentrated on the tibia A after the correction. Further, by forming the slit 4 from the straight portion 4a, when a bone cutting blade that moves on a parallel surface is used, interference between the bone cutting blade and the inner surface of the slit 4 can be prevented.
  • the slit 4 is the distance between the central portion 2 and the slit 4 each time the slit 4 is displaced by a predetermined angle ⁇ 'in the circumferential direction around the axis I. It may be designed so that r is shortened by a predetermined length ⁇ r. In this case, when the osteotomy portion is rotated around the hinge point H by a predetermined angle ⁇ ', the width of the gap becomes narrower by the length ⁇ r.
  • the predetermined angle ⁇ ' is equal to the correction angle ⁇ and the length ⁇ r is equal to the width of the gap between the side surface F and the concave surface G caused by the osteotomy
  • the side surface F and the concave surface G come into contact with each other to eliminate the gap. That is, after the correction, the side surface F can be brought into contact with the concave surface G without imposing a burden on the tibia A.
  • the strut portion 5 connects the center portion 2 and the center of the guide portion 3 to each other, but instead, the center portion 2 and another position of the guide portion 3 are connected to each other. You may connect to.
  • the support column portion 5 may connect the central portion 2 and one end portion of the guide portion 3 to each other.
  • the bone surgical instrument 1 may further include a movable portion 8 connected to the guide portion 3 so as to be movable in the circumferential direction around the axis I. ..
  • the movable portion 8 is a component for guiding the guide wire GW so that the guide wire GW is arranged in a predetermined positional relationship with respect to the hinge pin P1 inserted into the pin hole 2a.
  • the movable portion 8 can also be applied to the bone surgical instruments 10 and 20.
  • the movable portion 8 has a first portion 81 connected to the guide portion 3 and a second portion 82 connected to the first portion 81.
  • the first portion 81 is movable in the circumferential direction along the outer surface of the guide portion 3.
  • FIG. 8C shows an example of a connecting structure in which the first portion 81 is connected to the guide portion 3.
  • the guide portion 3 has a rail portion 3a protruding outward in the radial direction on the outer surface on the outer side in the radial direction.
  • the first portion 81 is a substantially C-shaped annular member surrounding the guide portion 3, and moves along the rail portion 3a.
  • the bone surgical instrument 1 is attached to both the left leg and the right leg by attaching the first portion 81 upside down to the guide portion 3. Can be used.
  • the movable portion 8 may have a screw 8a for temporarily fixing the first portion 81 to the guide portion 3.
  • the connecting structure is not limited to the above structure, the position of the first portion 81 in the vertical direction and the radial direction is stable with respect to the guide portion 3, and the first portion 81 is circumferential with respect to the guide portion 3. It can be changed arbitrarily as long as it can be moved in the direction.
  • the vertical direction is a direction parallel to the axis I.
  • the second portion 82 is arranged on the side opposite to the central portion 2 with respect to the guide portion 3.
  • the second portion 82 has at least one guide hole 9 that guides the guide wire GW in a direction parallel to the radial direction toward the axis I side.
  • the guide hole 9 is located on one side (lower side) in the vertical direction with respect to the guide portion 3, and penetrates the second portion 82 in a direction parallel to the radial direction.
  • a plurality of guide holes 9 may be arranged in a row in the vertical direction so that a plurality of guide wires GW can be inserted into the tibia A at the same time.
  • the hinge pin P1 can be inserted at a predetermined position with respect to the guide wire GW already inserted into the tibia A, or the hinge pin P1 has already been inserted into the tibia A.
  • the guide wire GW can be inserted at a predetermined position with respect to the hinge pin P1.
  • the central axis K of the guide hole 9 is offset with respect to the radial axis J in a direction orthogonal to both the axis I and the central axis K.
  • the radial axis J is a radial axis passing through the axis I and is parallel to the central axis K.
  • the offset amount of the central axis K from the radial axis J is designed so that the distance ⁇ d is substantially equal to the thickness of the osteocut blade, and preferably the distance ⁇ d is larger than 0 mm and 2 mm or less.
  • the distance ⁇ d is the distance in the offset direction from the axis I to the outer peripheral surface of the guide wire GW penetrating the guide hole 9.
  • the osteotomy blade is inserted along the outer peripheral surface of the guide wire GW.
  • the guide wire GW By arranging the guide wire GW at a position separated from the axis I by the thickness of the osteotomy blade, the rotation center of the osteotomy can be accurately aligned with the hinge point H.
  • the second portion 82 may further include a second guide portion 11 that guides the osteotomy blade along a plane orthogonal to the axis I during osteotomy of the lower surface E. ..
  • the second guide portion 11 of FIGS. 9A to 9C is a flat surface extending along a plane orthogonal to the axis I.
  • the second guide portion 11 of FIG. 9D is a flat slit extending along a plane orthogonal to the axis I. Flat surfaces and slits have a width wider than the width of the osteotomy blade.
  • the second guide portion 11 is arranged between the guide portion 3 and the guide hole 9 in the vertical direction, and is fixed from the guide hole 9 to the guide hole 9. Spread to 6 sides.
  • the osteotomy blade along the second guide portion 11 By moving the osteotomy blade along the second guide portion 11 when cutting the lower surface E, the lower surface E can be formed perpendicular to the axis I and the hinge pin P1.
  • the hinge pin P1 When the lower surface E is inclined with respect to the hinge pin P1, one of the hinge portion and the rough surface portion B may become excessively thin. By providing the second guide portion 11, such inconvenience can be prevented.
  • the guide hole 9 and the second guide portion 11 may be movable in the vertical direction with respect to the guide portion 3.
  • the second portion 82 includes a first member connected to the first portion 81 and a second member having a guide hole 9 and a second guide portion 11, and the second member has a second member with respect to the first member. It may be connected to the first member so as to be movable in the vertical direction. According to this configuration, the position of the lower surface E and the thickness of the rough surface portion B can be adjusted by adjusting the position of the second guide portion 11 in the direction parallel to the axis I.
  • the second portion 82 has a flat guide slit 12 circumscribing the guide hole 9 and extending in the vertical direction as a third guide portion for guiding the osteotomy blade at the time of osteotomy of the osteotomy line L. You may have.
  • the tibia A can be osteotomized in parallel with the guide wire GW while the bone surgical instrument 1 is placed on the tibia A.
  • the guide hole 9 has an inner diameter slightly larger than the outer diameter of the guide sleeve GS, and may guide the guide sleeve GS.
  • the second portion 82 has a width larger than the diameter of the guide wire GW and is parallel to the guide hole 9, as shown in FIGS. 9C and 9D. It may have an extending slit 13.
  • the slit 13 is formed below the guide hole 9 at the lowest position, extends over the entire length of the guide hole 9, and communicates the guide hole 9 with the outside of the second portion 82.
  • all the guide holes 9 communicate in the vertical direction, and the guide wire GW moves in the vertical direction between the guide hole 9 at the uppermost position and the guide hole 9 at the lowest position. It is possible.
  • the bone surgical instrument 1 can be removed upward from the tibia A with the hinge pin P1 and the guide wire GW inserted into the tibia A.
  • the second portion 82 is connected to the first portion 81 so as to be linearly movable in a direction parallel to the central axis K with respect to the first portion 81.
  • the second portion 82 has a slider 82a extending parallel to the central axis K, the slider 82a being movably supported by the first portion 81 in its longitudinal direction.
  • the second portion 82 can be arranged as close to the bone surface as possible, and the guide wire GW can be inserted into the tibia A and the osteotomy with the osteotomy blade can be performed with no play in the second portion 82.
  • a positioning mechanism for positioning the second portion 82 with respect to the first portion 81 may be provided.
  • the first portion 81 may be provided with a ball plunger (not shown), and the slider 82a may be provided with a plurality of holes 82b arranged in a row to receive the ball plungers.
  • a fixing member such as a fixing screw may be further provided.
  • the second portion 82 may be fixed to the first portion 81.
  • the movable portion 8 does not necessarily have to be composed of the two portions 81 and 82, and may be composed of a single member.
  • Bone surgical instruments 1 Central part 2a Pin hole 3 Guide part 4 Slit 5 Strut part 6 Fixed part 6a Fixed hole 7 Contact surface, concave surface 8 Movable part 9 Guide hole 11 Second guide part A Tibia B Rough surface part GW guide wire H hinge point (specific point) I axis P2 fixing pin (fixing member)

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
PCT/JP2020/043425 2019-12-05 2020-11-20 骨手術用器具 Ceased WO2021111907A1 (ja)

Priority Applications (4)

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JP2021562571A JP7309911B2 (ja) 2019-12-05 2020-11-20 骨手術用器具
CN202080083395.XA CN114760937B (zh) 2019-12-05 2020-11-20 骨手术用器具
EP20897311.5A EP4070741A4 (en) 2019-12-05 2020-11-20 INSTRUMENT FOR BONE SURGERY
TW109141515A TWI769597B (zh) 2019-12-05 2020-11-26 骨手術用器具

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JP2019-220047 2019-12-05

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CN115317068A (zh) * 2022-08-15 2022-11-11 宽瑞智能科技(苏州)有限公司 骨科手术机器人及其骨锯锯面校验方法和存储介质
TWI902211B (zh) * 2024-03-14 2025-10-21 日商奧林巴斯泰爾茂生醫材料股份有限公司 導引裝置
WO2025235858A1 (en) * 2024-05-10 2025-11-13 Forma Medical, Inc. Guide system for extremities and related methods

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Publication number Priority date Publication date Assignee Title
CN115317068A (zh) * 2022-08-15 2022-11-11 宽瑞智能科技(苏州)有限公司 骨科手术机器人及其骨锯锯面校验方法和存储介质
TWI902211B (zh) * 2024-03-14 2025-10-21 日商奧林巴斯泰爾茂生醫材料股份有限公司 導引裝置
WO2025235858A1 (en) * 2024-05-10 2025-11-13 Forma Medical, Inc. Guide system for extremities and related methods

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JP7309911B2 (ja) 2023-07-18
TWI769597B (zh) 2022-07-01
EP4070741A4 (en) 2023-12-20
EP4070741A1 (en) 2022-10-12
TW202128091A (zh) 2021-08-01
CN114760937A (zh) 2022-07-15
JPWO2021111907A1 (https=) 2021-06-10
CN114760937B (zh) 2025-07-04

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