Therapeutic instrument

Abstract

A therapeutic device is configured so as to be provided with a bone cement molding tool and a bone cement fixing tool, which are inserted into an internal fixation tool that supports bone cement filled in the vertebral body from the pedicle of the vertebral body and performs internal fixation. The internal fixture has a through-hole in the central axis direction from the head to the tip, and can be inserted into and removed from the bone cement along the central axis thereof. After the bone cement is screwed into the internal fixation tool, the bone cement is inserted into the internal fixation tool through the through hole to form a hole having a predetermined shape. The bone cement fixture has a distal end portion inserted into the formed hole, and the distal end portion is inserted into the hole through the through hole of the internal fixture, thereby suppressing rotation of the bone cement and / or movement in the extraction direction.

Description

TECHNICAL FIELD

[0001] The present application relates to a treatment instrument for operating a cylindrical internal fixation instrument for medical use, and particularly, to an internal fixation instrument for a vertebral body which can be appropriately used for an internal fixation surgery. BACKGROUND

[0002] As a treatment method for a compression fracture of a vertebra, a vertebral body formation surgery and a spinal fixation surgery are known. A vertebra is composed of stacked vertebral bodies, and pedicles, laminae, and articular processes which support the vertebral bodies. The vertebral body is a cylindrical bone which sandwiches and encloses a nucleus pulposus with a fibrous ring, and is supported by two pedicles extending from the lamina. The lamina is connected to the upper and lower vertebrae through the articular processes and supports the vertebral body through the pedicles, thereby forming a spine. The compression fracture is a disease in which the vertebral body is crushed and damaged due to a compression in the vertical direction. The vertebral body formation surgery is a surgery for reconstructing the crushed vertebral body, and for example, a surgery in which a medical cement is filled in the vertebral body is adopted. The spinal fixation surgery is a surgery in which an instrument is used to fix the crushed vertebral body and the healthy vertebral bodies above and below the crushed vertebral body. Screws are respectively screwed into the crushed vertebral body and the healthy vertebral bodies above and below the crushed vertebral body from the pedicles, and the heads of the screws are connected to and fixed to a rod which extends in the vertical direction. If the symptoms are mild, the vertebral body formation surgery is adopted, but in the case of severe symptoms, the spinal fixation surgery is required.

[0003] Various screws used in these treatments have been proposed.

[0004] In Patent Literature 1, a medical screw is disclosed which has a through-hole along the longitudinal direction of the central axis, and an opening in the side surface which communicates with the through-hole. An injection instrument such as a syringe is attached to the head of the screw, and a bone cement, a physiologically active substance, or the like is injected from the through-hole through the opening in the side surface to the surrounding bone, thereby strengthening the surrounding bone (

[0053] to

[0057] , Figs. 6-8).

[0005] In Patent Literature 2, a medical screw is disclosed which can be easily removed from a fractured site which has been screwed. In a medical screw in which a hollow portion is formed from the head to the tip end along the central axis, a thread is formed in the side surface, and is screwed into a bone. An opposite thread (opposite internal thread portion) is provided near the inner side of the tip end of the hollow portion of the screw, and a removal operation jig having a tip end portion which engages with the opposite internal thread portion is used, whereby the screw can be removed. More specifically, the removal operation jig is inserted into the hollow portion and the tip end portion is engaged with and integrated with the opposite internal thread portion of the screw, and the removal operation jig is rotated to pull the screw out of the body.

[0006] PRIOR ART DOCUMENTS

[0007] PATENT LITERATURE

[0008] Patent Literature 1: US Publication 2011 / 0040337A1

[0009] Patent Literature 2: Japanese Patent Application Publication No. 2016-209295 SUMMARY

[0010] PROBLEMS TO BE SOLVED BY THE INVENTION

[0011] The present inventors found that the development of medical instruments and screws suitable for a surgical procedure combining the above-described vertebroplasty and pediculoplasty is not sufficient.

[0012] The present inventors invented a treatment instrument solving the problem and filed an international application as PCT / JP2022 / 036147. The invention is a treatment instrument that is integrated with a screw having a through-hole along a central axis and a threadable thread on a side surface, and is configured to be able to inject bone cement into a lesion through the through-hole of the screw in a state where a driver is connected to a head of the screw, and then to screw the screw into the bone cement. After the bone cement is injected, the driver does not need to be reinstalled, and the driver can be operated as is, so the screw can be quickly screwed in before the bone cement solidifies.

[0013] On the other hand, in the existing screw like that of Patent Literature 1, it is not assumed to screw the screw into the bone cement that has been injected in advance, but to inject cement or the like from an opening of a side wall around the screw after the screw is screwed in to reinforce the bone around it. Therefore, it is considered that the bone that engages with the thread of the screw is basically removed relatively easily by reversing the thread. Nevertheless, in the case where it is anticipated that it is difficult to remove, the screw that assumes removal and a removal operation jig described in Patent Literature 2 are used.

[0014] The present inventors conducted further research on the danger that the engagement of the screw and the bone cement is too strong to smoothly remove the screw, and as a result, it was noted that such danger becomes apparent in a case where the combination of the engagement of the bone cement and the screw is stronger than the healing of the bone cement and the body tissue such as the bone around it. In this case, it was noted that even the jig for removal described in Patent Literature 2 does not necessarily solve the problem. That is because the jig for removal described in Patent Literature 2 can strongly link the screw and the driver, and can transmit a strong force to the screw, so it is helpful for removal in the case where the surrounding is the body tissue such as the bone of the patient, but in the case where the combination of the engagement of the bone cement and the screw is stronger than the healing of the bone cement and the body tissue such as the bone around it, there is a concern that the screw is replaced with the bone cement to be separated from the body tissue around it instead of being removed from the bone cement, and it does not help removal.

[0015] Therefore, in order to solve this problem, the inventors have invented an internal fixation device that facilitates easy removal, and filed an international application as PCT / JP2023 / 022593. This invention's internal fixation device is a device that replaces the aforementioned screws, and instead of forming threads, a groove is formed in the portion where bone cement is inserted. Threads allow the surrounding bone cement to expand as it enters, thus preventing the formation of gaps. In contrast, the bone cement enters and remains in the groove due to its adhesiveness, thus forming gaps, or at least a weaker adhesion to the bone cement, even if not to the extent of forming gaps. Therefore, removal can be performed with less force.

[0016] Here, internal fixation devices refer to devices that insert bone cement from the pedicle into the vertebral body and support the bone cement in the vertebral body from the pedicle side to perform internal fixation, and are redefined as devices that include the aforementioned screws.

[0017] The inventors have noticed a further new problem. When inserting an internal fixation device into bone cement, it is typically driven in using tapped threads (at least on the head side for driving into the pedicle), but during removal, the device is rotated in the opposite direction to the driving initiation. However, when the bond between the internal fixation device and the bone cement is stronger than the healing between the bone cement and surrounding bone or other affected tissues, there is a problem where the bone cement rotates and cannot be removed.

[0018] The purpose of this invention is to provide a treatment device that assists in the removal of an internal fixation device inserted from the pedicle into bone cement pre-filled in the vertebral body.

[0019] The means used to solve the above-mentioned problems will be described below, but other problems and new features will become clear from the description in this specification and the accompanying drawings.

[0020] Methods for solving problems

[0021] According to one embodiment of the present invention, as follows.

[0022] That is, a treatment device comprising an internal fixation device for internal fixation by inserting into bone cement filled into the vertebral body and supporting the pedicle, a bone cement forming device, and a bone cement fixing device, configured as follows: The internal fixation device has a through hole along its central axis from the head to the anterior end, allowing insertion and removal relative to the bone cement along its central axis. The bone cement forming device is inserted into the bone cement through the through hole of the internal fixation device to form a hole of a predetermined shape. The bone cement fixing device has a front end that is inserted into the formed hole; by inserting the front end into the hole through the through hole of the internal fixation device, rotation and / or movement in the removal direction of the bone cement are inhibited.

[0023] The effects of the invention

[0024] The effects obtained by one of the above embodiments will be explained simply as follows.

[0025] That is, it is possible to provide a treatment device that assists in the removal of an internal fixation device inserted from the pedicle into bone cement pre-filled in the vertebral body. Attached Figure Description

[0026] Figure 1 This is an explanatory diagram schematically showing the cross-sectional structure of the therapeutic device of the present invention, which includes a bone cement molding device, as an example of its configuration.

[0027] Figure 2 This is an explanatory diagram schematically showing the cross-sectional structure of the therapeutic device of the present invention, which includes a bone cement fixation device, as an example of its configuration.

[0028] Figure 3 This is an explanatory diagram showing the bottom surface of the anterior end (quadrilateral) of each of the bone cement molding device and bone cement fixation device as viewed from the proximal end side, in order to illustrate the first configuration example.

[0029] Figure 4 This is an explanatory diagram showing the bottom surface of the anterior end (star-shaped) of each of the bone cement molding device and bone cement fixation device as viewed from the proximal end side, in order to illustrate the third configuration example.

[0030] Figure 5 This is an explanatory diagram showing the appearance and cross-sectional structure of the front end portion of the bone cement molding device and the bone cement fixation device from an overhead view, in order to illustrate the first configuration example.

[0031] Figure 6 This is an explanatory diagram showing the bottom surface and cross-sectional structure of the front end of each component from an overhead view, in order to illustrate a second example of the bone cement molding device and the bone cement fixation device.

[0032] Figure 7 This is an explanatory diagram showing an example of the use of the internal fixation device of the present invention from an aerial view.

[0033] Figure 8 These are top views, front views, and bottom views illustrating an example of the internal fixation device of the present invention.

[0034] Figure 9 This is an explanatory diagram showing a cross-sectional structure schematically in order to illustrate an example of the configuration of the therapeutic device of the present invention.

[0035] Figure 10 This is an illustrative diagram schematically showing the first half of the sequence of implanting an internal fixation device during treatment using the therapeutic apparatus of the present invention.

[0036] Figure 11This is an illustrative diagram illustrating an example of the latter half of the sequence of implanting an internal fixation device during treatment using the therapeutic apparatus of the present invention.

[0037] Figure 12 This is an illustrative diagram illustrating another example of the sequence of implantation of an internal fixation device in treatment using the therapeutic apparatus of the present invention.

[0038] Figure 13 This is an illustrative diagram illustrating an example of the sequence of removal of internal fixation devices during treatment using the therapeutic apparatus of the present invention.

[0039] Figure 14 These are illustrative diagrams illustrating other examples of the sequence of removal of internal fixation devices during treatment using the therapeutic apparatus of the present invention.

[0040] Figure 15 This is an explanatory diagram showing the bottom surface of the anterior end (cross-shaped) of each of the four components, which is intended to illustrate the fourth example of the bone cement molding device and the bone cement fixation device.

[0041] Figure 16 This is an explanatory diagram showing the appearance and cross-sectional structure of the front ends of the bone cement molding device and the bone cement fixation device from an overhead view, in order to illustrate the fifth example of their configuration.

[0042] Figure 17 This is an explanatory diagram showing the appearance and cross-sectional structure of the front ends of the bone cement molding device and the bone cement fixation device from an overhead view, in order to illustrate the sixth example of their configuration.

[0043] Figure 18 This is an explanatory diagram illustrating an example of the sequence of removal of internal fixation devices during treatment using the treatment device according to the third embodiment of the present invention.

[0044] Figure 19 This is an illustrative diagram illustrating other examples of the sequence of removal of internal fixation devices during treatment using the treatment apparatus of the third embodiment of the present invention.

[0045] Figure 20 These are explanatory diagrams schematically illustrating examples of the configuration of the bone cement molding device and actuator of the therapeutic apparatus according to the fourth and fifth embodiments of the present invention.

[0046] Figure 21 This is an explanatory diagram schematically showing the latter half of the sequence of implanting internal fixation devices during treatment using the treatment device of the fifth embodiment.

[0047] Figure 22This is an explanatory diagram illustrating an example of the sequence of removal of internal fixation devices during treatment using the treatment device according to the sixth embodiment of the present invention. Detailed Implementation

[0048] 1. Overview of the implementation method

[0049] First, a summary of the representative embodiments disclosed in this application will be given. The reference numerals in the drawings, which are marked in parentheses and referred to in the summary description of the representative embodiments, are merely illustrative of the cases in which the constituent elements of the reference numerals are included.

[0050] Additionally, in this instruction manual, "proximal" refers to the side closer to the patient's midline, and "distal" is a medical term referring to the side further away. Bone cement is a medical cement, for example, composed primarily of calcium phosphate and polymethyl methacrylate, which hardens over time.

[0051] [1] Removal aids that inhibit the rotation / removal of bone cement ( Figures 1-5 , Figures 15-17 , Figure 20 )

[0052] The representative embodiment disclosed in this application is a treatment device (100) comprising an internal fixation device (10) for internal fixation by inserting bone cement into the vertebral body supported by the pedicle, a bone cement forming device (50) and a bone cement fixing device (60), configured as follows.

[0053] The aforementioned internal fixation device has a through hole (16) along the central axis from the head (13) to the front end, which can be inserted and removed relative to the bone cement (1) along the central axis.

[0054] The bone cement forming device is inserted into the bone cement through the through hole of the internal fixation device to form a hole (2) of a specified shape.

[0055] The aforementioned bone cement fixation device has a front end (61) that is inserted into the aforementioned hole. The front end is inserted into the aforementioned hole by means of inserting the bone cement (1) that forms the aforementioned hole through the aforementioned through hole of the aforementioned internal fixation device, thereby suppressing the rotation of the aforementioned bone cement about the aforementioned central axis and / or the movement in the pull-out direction.

[0056] Therefore, a treatment device can be provided that assists in the removal of an internal fixation device inserted from the pedicle into bone cement pre-filled in the vertebral body and supports the bone cement for internal fixation.

[0057] [2] Fixation is performed by screwing the tapped thread of the bone cement fixation device into the round hole. Figure 16 , Figure 17 )

[0058] Based on the treatment device of [1], the front end of the above-mentioned bone cement forming device is cylindrical ( Figure 16 Or a cylindrical cone with a diameter that decreases towards the front end ( Figure 17 ). It is capable of forming a cylindrical or cylindrical-conical hole (2) with a diameter decreasing in the depth direction. The above-mentioned bone cement fixation device has threads that tap and are turned into the sidewalls of the hole.

[0059] Therefore, bone cement fixation devices can inhibit the movement of bone cement in both the rotational and extraction directions.

[0060] [3] Bone cement molding tools also have threads for tapping the sidewalls. Figure 20 )

[0061] Based on the treatment device of [2], the above-mentioned bone cement molding device has threaded teeth (54) that tap and twist into the sidewall of the above-mentioned hole.

[0062] This allows for the formation of a hole with a pre-engraved groove for tapping on the sidewall. When the internal fixation device needs to be removed, the threads of the cement fixation device are screwed into the groove pre-formed in the hole, thus enabling removal with less force and making it easier to remove the cement fixation device after the internal fixation device has been removed.

[0063] [4] Driver ( Figure 1 , Figure 2 , Figure 20 )

[0064] Based on [2] or [3], the treatment device (100) further includes an actuator (20), the internal fixation device at the head (13) is connectable to the actuator, the actuator having a through hole that communicates with the internal fixation device when connected to it, thereby allowing the front ends of the bone cement forming device and the bone cement fixation device to pass through.

[0065] Thus, it is possible to provide a driver (20) that can be used in both the insertion and removal of the internal fixation device (10) during surgery.

[0066] [5] The bone cement molding apparatus and the actuator can be connected ( Figure 20 )

[0067] Based on the treatment device of [4], the bone cement forming device is inserted into the through hole of the actuator connected to the internal fixation device and protrudes from the front end of the internal fixation device by a specified length.

[0068] Therefore, a bone cement forming device can be inserted to form a hole while the actuator and internal fixation device are connected, thereby reducing the number of procedures.

[0069] [6] Bone cement molding equipment and actuators are capable of loading and unloading ( Figure 20 )

[0070] Based on the treatment device of [5], the bone cement molding device and the driver can be detachably connected.

[0071] Therefore, it is possible to selectively and flexibly use the simultaneous or separate methods of hole formation and insertion of internal fixation devices into bone cement.

[0072] [7] Bone cement molding apparatus and actuator are integrated via threads ( Figure 20 )

[0073] Based on the treatment device of [6], the aforementioned actuator has a threaded structure (53) at the distal end that can be connected to the aforementioned bone cement molding device.

[0074] Therefore, the operability of the treatment device is improved when the hole is formed and the internal fixation device is inserted into the bone cement at the same time.

[0075] [8] Bone cement fixation devices are capable of attaching and detaching handles ( Figure 14 )

[0076] Based on any of the treatment devices in [2] to [7], the above-mentioned bone cement fixation device has a structure in which the handle portion (62) and the shaft portion can be detached.

[0077] Therefore, the handle can be installed to suppress the rotation of the bone cement fixation device, and the handle can be removed when the bone cement fixation device is removed, thereby increasing the degree of freedom of manipulation.

[0078] [9] Salesperson ( Figure 22 )

[0079] Based on any one of [2] to [8], the above-mentioned treatment device further includes a guide pin (40), and the above-mentioned bone cement fixation device has a through hole (64) through which the guide pin can pass.

[0080] Therefore, the bone cement fixation device can be guided along the pre-inserted guide pin to the hole in the bone cement in the affected area.

[0081]

[10] A bone cement fixation device that abuts against the sidewall of a rectangular hole to inhibit the rotation of the bone cement. Figure 5 )

[0082] Based on the treatment device of [1], the front end of the above-mentioned bone cement forming device is prismatic ( Figure 5 (a) or a prism-pyramidal shape whose cross-section decreases towards the front end ( Figure 5 (b)) can form a prism-shaped hole (2) or a prism-pyramidal shape whose cross-section decreases in the depth direction. The above-mentioned bone cement fixation device has a front end shape that abuts against the sidewall of the hole and can suppress the rotation of the bone cement.

[0083] Thus, the cement fixation device abuts against the sidewall of the hole, thereby preventing rotation of the cement. The cement fixation device is only inserted into the hole, making it easy to remove.

[0084]

[11] Bone cement fixation devices are capable of attaching and detaching handles ( Figure 14 )

[0085] Based on the treatment device of

[10] , the above-mentioned bone cement fixation device has a structure in which the handle part (62) and the shaft part can be detached.

[0086] Therefore, the handle can be installed to suppress the rotation of the bone cement fixation device, and the handle can be removed when the bone cement fixation device is removed, thereby increasing the degree of freedom of manipulation.

[0087]

[12] Driver

[0088] Based on

[10] or

[11] , the aforementioned treatment device further includes an actuator, the internal fixation device being connectable to the actuator at its head, the actuator having a through hole that communicates with the aforementioned through hole of the internal fixation device when connected to it, thereby allowing the front end portion of the bone cement forming device and the bone cement fixation device to pass through.

[0089] Therefore, a driver (20) is provided that can be used in both the insertion and removal of the internal fixation device (10) during surgery.

[0090]

[13] Salesperson ( Figure 22 )

[0091] Based on any one of

[10] to

[12] , the above-mentioned treatment device further includes a guide pin (40), and the above-mentioned bone cement fixation device has a through hole (64) through which the guide pin can pass.

[0092] Therefore, the bone cement fixation device can be guided along the pre-inserted guide pin to the hole in the bone cement in the affected area.

[0093] 2. Details of the implementation method

[0094] The implementation method is described in further detail.

[0095] [Implementation Method 1]

[0096] Figure 7 This is an explanatory diagram showing an example of the use of the internal fixation device 10 from an overhead view. In a standing position, the spine is formed by multiple vertebrae 90° overlapping vertically. Figure 7 In the diagram, a vertebral body 90 is shown in a perspective view from above and below. A pair of pedicles 91 support the vertebral body 90, and these pedicles 91 are connected by vertebral arches 92. The portion enclosed by the vertebral body 90, pedicles 91, and vertebral arches 92 is the spinal canal 93. Compression fracture is a condition in which the vertebral body is crushed by forces in the vertical direction. In treatment using the internal fixation device 10 of the present invention, as shown in reference... Figure 10 as well as Figure 11 As described later, bone cement 1 is injected into the vertebral body 90 to fill the space, and the internal fixation device 10 is inserted (twisted) before it hardens, supported from the pedicle 91 side. In other words, the internal fixation device 10 is inserted from the pedicle 91 into the bone cement 1 pre-filled in the vertebral body 90, and if the bone cement 1 hardens, it is supported from the pedicle 91 and fixed in the vertebral body 90 by the internal fixation device 10. At this time, the internal fixation device 10 of the present invention is a device that screws the bone cement 1 into the vertebral body 90 while tapping the bone hole formed in the pedicle 91. For example, it can also be a conventional screw as described in Patent Document 1, but it is not necessary to have threads for tapping on the front end side of the embedded bone cement 1.

[0097] Figure 8 These are top views (a), front views (b), and bottom views (c) illustrating an example configuration of an easily removable internal fixation device 10, for which international application PCT / JP2023 / 22593 has been filed. The rear and left / right views are identical to the front view (b), except that the groove 14 and threaded teeth 15 are positioned extending from the front view (b), and therefore are omitted from the drawings. The internal fixation device 10 includes a cylindrical shaft 12 and a connecting portion 13 at the distal end of the shaft 12 that can connect to an actuator. The shaft 12 has a helical groove 14 on its proximal side. The shaft 12 is preferably cylindrical as illustrated in the figures and has a through hole 16 extending along its central axis from the distal end to the proximal end. The through hole 16 can, for example, allow a guide pin to pass through. Alternatively, the through hole 16 can also be configured to allow the passage of bone graft devices, balloon catheters, bone cement injectors, etc. The connecting portion 13 of the head is configured as a hexagonal prism-shaped recess, designed to engage with a driver (not shown) and allow the internal fixation device 10 to rotate as a whole, in a manner similar to engaging with a hexagonal wrench. Figure 8In this specification, a hexagonal prism-shaped head (connecting part) is shown as an example, assuming it is connected to a hexagonal wrench-shaped driver head. However, this shape is arbitrary as long as it can transmit rotational force; for example, it can be changed to a star shape, a triangle shape, a quadrilateral shape, a cross shape, etc. Furthermore, in this specification, reference numeral 13 may be referred to as "head" to emphasize its position in the internal fixing device 10, or as "connecting part" to emphasize its function of connecting to the driver.

[0098] The depth of the groove 14 of the internal fixation device 10 can also be uniform, but it is more preferable that the proximal side (anterior side) of the shaft 12 is deeper than the distal side (head side). As the internal fixation device 10 is screwed into the bone cement 1 while rotating spirally along the groove 14, the bone cement 1 enters deeper into the groove 14 because the proximal side (anterior side) that first contacts the bone cement 1 becomes deeper. As it is screwed in, it is delivered along the spiral of the groove 14 to the shallower distal side (head side), thus allowing the bone cement 1 to smoothly enter the groove 14 and be firmly fixed thereto. On the other hand, during removal, the internal fixation device 10 separates from the bone cement 1 while rotating in the opposite direction along the spiral of the groove 14, thus reducing the force required for removal.

[0099] The shaft 12 of the internal fixation device 10 is more preferably provided with an inclined portion 17 whose diameter gradually decreases from the central portion toward the proximal end. When the internal fixation device 10 is screwed into the bone cement 1, the resistance at the initial insertion of the bone cement 1 is reduced, thereby reducing the force required for removal.

[0100] A threaded tooth 15 may also be provided on the distal side (head side) of the shaft 12 of the internal fixation device 10. The threaded tooth 15 is a spiral protrusion protruding outward from the outer peripheral surface of the shaft 12, which has the function of tapping the surrounding bone and advancing along the central axis as the internal fixation device 10 (shaft 12) rotates. The threaded tooth 15 taps and advances the pedicle 91, thereby strongly fixing the internal fixation device 10 and stably supporting the bone cement 1 inserted into the vertebral body 90 with the shaft 12.

[0101] The thread 15 and the groove 14 are preferably formed with equal leads. The lead is the distance traveled along the central axis relative to the rotation of the shaft 12. Preferably, the distance the shaft 12 travels while the thread 15 is tapping the pedicle 91 is the same as the distance the shaft 12 travels along the groove 14 spirally while the bone cement 1 is being screwed in. However, a precise match is not required, and the intentions may differ. For example, by making the lead of the groove 14 greater than the lead of the thread 15, after the groove 14 at the front end of the shaft 12 is partially screwed into the bone cement 1 and the thread 15 begins tapping the pedicle, a force can be applied that brings the bone cement 1 closer to the pedicle side as the internal fixation device 10 (shaft 12) rotates.

[0102] The number of strips in the groove 14 and the thread 15 can be different. For example, the number of strips in the groove 14 can be less than the number of strips in the thread 15. This makes the fixation of the pedicle 91 to the thread 15 more stable and allows for a proper design of the bonding force between the internal fixation device 10 and the bone cement 1. As described above, it is preferable to make the lead of the groove 14 and the thread 15 equal. In this case, although a new problem arises in properly setting the contact area with the object, this problem is solved by designing the number of strips independently. If the number of strips in the groove 14 is reduced, the contact area with the bone cement 1 can be reduced, thereby weakening the force required for extraction. On the other hand, by increasing the contact area between the pedicle 91 and the thread 15, the fixation of the internal fixation device 10 and the pedicle 91 can be strengthened. By optimizing the number of strips rather than the spacing, the relationship between the bone cement 1 and the groove 14, and the relationship between the pedicle 91 and the thread 15, can be optimized independently.

[0103] Furthermore, in this specification, "internal fixation device" refers to a device that is inserted into bone cement pre-filled in the vertebral body through the pedicle, and which, if the bone cement hardens, fixes the bone cement in the vertebral body through the pedicle. Therefore, the internal fixation device in this specification is not only the easily removable internal fixation device 10 that has been internationally applied for under PCT / JP2023 / 022593, but also includes existing screws without grooves 14, without threads 15, without both grooves 14 and threads 15, or even screws integrally formed with threads.

[0104] Figure 9 This is an explanatory diagram schematically showing the cross-sectional structure of the treatment device 100 to illustrate its configuration example. Figure 9 In this drawing, the scale along the central axis (vertical direction on the paper) is compressed, and emphasis is placed on the direction along the patient's body surface (horizontal direction on the paper). The treatment device 100 includes a cylindrical actuator 20 capable of twisting the internal fixation device 10 into the bone, and an inner cylinder 30 into which the actuator 20 is inserted, as follows.

[0105] The front end of the internal fixation device 10 is not sharp, allowing for the insertion and removal of soft vertebral body excision devices such as balloons. It has threads 15 on its outer wall for tapping bone and cement, and a through hole 16 along the central axis through which the inner cylinder 30 passes from the head 13 to the front end. The actuator 20 is configured to move along the central axis, thereby engaging with and connecting to the head 13 of the internal fixation device 10, and thus transmitting rotational force about the central axis to the internal fixation device 10. For example, the front end of the actuator 20 may be formed in the shape of a hexagonal wrench (hexagonal prism), and the head 13 of the internal fixation device 10 may have a hexagonal groove (recess). (See reference...) Figure 8As described above, the shape of the front end of the driver and the shape of the screw head can be engaged simply by insertion, and can also be a shape other than hexagonal, such as star-shaped. If the driver 20 is slid along the central axis toward the head of the inner retainer 10, the front end of the driver 20 is embedded in the head 13 of the inner retainer 10, so that the driver 20 can be turned into the screw. If the driver 20 is pulled out, it will simply fall off.

[0106] The inner cylinder 30 is inserted from the distal end of the actuator 20 through a through hole between the actuator 20 and the internal fixation device 10, and has a front end portion 32 that protrudes closer to the front end of the internal fixation device 10. With the front end portion 32 protruding closer to the front end of the internal fixation device 10, the inner cylinder 30 is connected to and integrated with the internal fixation device 10 and the actuator 20, improving the operability of twisting in the internal fixation device 10, etc. Furthermore, by inserting the guide pin 40, the integration becomes secure, making it impossible to pull the inner cylinder 30 out of the internal fixation device 10 and the actuator 20.

[0107] An example of a construction for integrating the internal fixation device 10, the actuator 20, and the inner cylinder 30 is described.

[0108] The front end 32 of the inner cylinder 30 is divided into multiple tongues 31 along the central axis, and each tongue 31 has a protrusion 33 in a direction away from the central axis. The protrusion 33, as described later, functions as a notch to prevent the internal fixing device 10 from detaching from the inner cylinder 30; therefore, reference numeral 33 is used as a notch in the drawing. The multiple tongues 31 are formed, for example, by dividing the cylindrical inner cylinder 30 from the front end side with a slit. The number of divisions can be arbitrary, for example, 4 divisions, 6 divisions, 2 divisions, 3 divisions, etc. Furthermore, certain processing can be performed to achieve appropriate elasticity (e.g., heat treatment, thinning processing, bonding of a more elastic metal). The elasticity of the tongues 31 is designed to allow for appropriate flexural flexibility. For example, when the inner cylinder 30 passes through the through hole of the actuator 20, the notch 33 is pressed by the inner wall of the through hole, thereby flexing towards the central axis to allow the inner cylinder 30 to pass through. If the notch 33 protrudes closer to the front end of the internal fixation device 10, it is designed to hook the notch 33 onto the front end of the internal fixation device 10 by flexing back. If the notch 33 is made into a smooth shape, it can be configured such that after the notch 33 protrudes from the front end of the internal fixation device 10, the force of pulling out the inner cylinder 30 is used to pull the notch 33 into the through hole 16 of the internal fixation device 10, causing the tongue 31 to flex again towards the central axis, thereby allowing the inner cylinder 30 to be pulled out. By inserting the guide pin 40, the tongue 31 can no longer flex towards the central axis, thus making it impossible to pull the inner cylinder 30 out of the internal fixation device 10 and the actuator 20.

[0109] In addition, such as Figure 9As shown, the actuator 20 and the inner cylinder 30 are more preferably configured to be connected at their distal ends. A cylindrical connecting portion 25 with external threads 26 on its outer circumferential surface is provided at the distal end of the actuator 20. A groove-shaped connecting portion 35 capable of receiving the cylinder is provided at the distal end of the inner cylinder 30, and an internal thread 36 is formed to engage with the external threads 26. The relationship between the concave and convex surfaces, and between the external and internal threads, can be reversed, or other connection mechanisms may be used. Furthermore, as... Figure 9 As illustrated, it is preferable to have a handle 27 on the drive 20 and a handle 37 on the inner cylinder 30, forming an integrated structure that is easy to grip during connection. The connection can be made by threads as in this example, or a locking mechanism (not shown) can be further provided to prevent the connection from coming loose.

[0110] The therapeutic device 100 of the present invention comprises an internal fixation device 10 for internal fixation by inserting bone cement into the vertebral body supported by the pedicle, a bone cement molding device 50 and a bone cement fixation device 60, and is configured as follows.

[0111] First, as a prerequisite, the internal fixation device 10 is configured to have a through hole 16 along a central axis from the head 13 to the anterior end (proximal end), allowing for insertion and removal relative to the bone cement 1 along this central axis. As an example, reference is made to... Figure 8 The above explanation.

[0112] Figure 1 This is an explanatory diagram schematically showing a cross-sectional structure to illustrate an example of the configuration of the therapeutic device 100 of the present invention, which includes a bone cement molding device 50. Figure 1 In this drawing, the scale along the central axis (vertical direction on the paper) is compressed, emphasizing the direction along the patient's body surface (horizontal direction on the paper). The internal fixation device 10 and the actuator 20 each have a through hole along the central axis, configured such that their through holes communicate with each other when connected. The bone cement forming device 50 is inserted from its distal end into the through hole that communicates with the internal fixation device 10 and the actuator 20 when connected, and is configured such that its anterior end 51 protrudes proximally from the front end of the internal fixation device 10. After bone cement 1 is inserted into the internal fixation device 10, the bone cement forming device 50 forms a hole 2 of a predetermined shape by inserting bone cement 10 through the through hole 16. Figure 1The bone cement molding device 50 shown has a handle 52, but it is not important for the bone cement molding device 50 to rotate. What is important is that the front end 51 is used to limit the penetration in a way that prevents it from going too deep, so it does not need to be in the shape of a handle. The front end 51 is designed to protrude from the front end of the internal fixation device 10 to the desired depth when the bone cement 1 is molding through the hole 2. The desired depth is arbitrary, for example, about 1 cm. The amount of protrusion is marked or printed on the distal end of the shaft of the bone cement molding device 50 in a way that indicates the amount of protrusion. In order to prevent extreme protrusion, a limiter with a diameter larger than the through hole of the actuator 20 can also be provided. In addition, the limiter can also function by adjusting the position of the mounting handle 52. Alternatively, as long as the bone cement molding device 50 is made to be able to be connected to the actuator 20 by means of threads, the internal fixation device 10 can be screwed into the bone cement while molding through the hole 2. Even without controlling the depth of the hole 2 separately through the bone cement forming device 50, if the length of the internal fixation device 10 is accommodated to an assumed depth, the hole 2 can be naturally formed until the hole 2 reaches a predetermined depth (e.g., a position 1 cm deeper than the front end of the internal fixation device 10).

[0113] Figure 2 This is an explanatory diagram schematically showing a cross-sectional structure to illustrate an example of the configuration of the therapeutic device of the present invention, including the bone cement fixation device 60. Figure 1Similarly, the scale in the central axis direction (vertical direction on the paper) is compressed, emphasizing the depiction along the direction of the patient's body surface (horizontal direction on the paper). The bone cement fixation device 60, like the bone cement molding device 50, is inserted from its distal end into the through hole that connects the internal fixation device 10 and the actuator 20, and is configured such that its anterior end 61 protrudes proximally from the front end of the internal fixation device 10. The connecting through hole has a circular cross-section, and the inserted bone cement fixation device 60 also has a circular cross-section, ensuring that their rotational movements do not interfere with each other. In simple terms, even if the actuator 20 is rotated, the bone cement fixation device 60 does not rotate. The bone cement fixation device 60 has an anterior end 61 that is inserted into the hole 2 formed in the bone cement molding device 50. The anterior end 61 has, for example, the same shape as the one described above, and the bone cement 1 with the hole 2 is inserted through the through hole 16 of the internal fixation device 10. The insertion of the anterior end 61 into the hole 2 thereby inhibits the rotation of the bone cement 1 about its central axis. Here, "same shape" does not mean identical even in size. It is sufficient that the front end 61 of the bone cement fixation device 60 is inserted into the hole 2 formed by the front end 51 of the bone cement molding device 50, and that rotation of the bone cement 1 is impeded. Of course, it is preferable to allow for a degree of ease in smooth insertion. This applies throughout this specification. Since the front end 61 of the bone cement fixation device 60 only needs to be inserted into the hole 2 formed by the front end 51 of the bone cement molding device 50, "same shape" is a sufficient but not necessary condition, and various shapes can be used, as will be described later. Furthermore, when the front end 61 of the bone cement fixation device 60 is inserted into the hole 2 formed by the front end 51 of the bone cement molding device 50, its front end abuts against the bottom of the hole 2, thereby suppressing any movement in the direction of pulling out the bone cement 1.

[0114] Therefore, a treatment device is provided to assist in the removal of an internal fixation device inserted from the pedicle into bone cement 10 pre-filled in the vertebral body.

[0115] The cement fixation device 60 is more preferably provided with a handle 62 at its distal end. As described above, the rotational movements of the actuator 20 and the inserted cement fixation device 60 do not interfere with each other. Therefore, when the actuator 20 is rotated, the handle 62 can be used to pre-suppress the rotation of the cement fixation device 60 without it rotating together. In addition, the handle 62 can also be configured to be detachable as described later.

[0116] exist Figure 2 The illustration depicts the handle 62 in contact with the distal end of the actuator 20 with the anterior end 61 of the cement fixation device 60 slightly protruding from the anterior end of the internal fixation device 10. However, in reality, the length of the cement fixation device 60 is longer than the example shown. (As cited...) Figure 13As will be described later, with the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1, the handle 62 is positioned in a distally dissociated position for removing the internal fixation device 10 (see reference). Figure 13

[24] and

[25] ). When the actuator 20 is connected to the internal fixation device 10, a scale indicating the degree to which the front end 61 of the bone cement fixation device 60 protrudes beyond the front end of the internal fixation device 10 can be set on the distal side of the bone cement fixation device 60. When the bone cement fixation device 60 is inserted into the internal fixation device 10 before removal, the insertion of the bone cement fixation device 60 stops in the hole 2 formed in the bone cement 1, but in the event that the bone cement 1 is damaged and does not stop in the hole 2, attention can be drawn in a way that does not insert beyond the assumed length and damage the surrounding body tissue. In addition, a limiter mechanism can be provided to prevent excessive insertion.

[0117] The shapes of the front end 51 of the bone cement molding device 50 and the front end 61 of the bone cement fixation device 60 will be described in further detail. For example, the aforementioned "prescribed shape" is preferably prismatic.

[0118] Figure 3 as well as Figure 5 These are explanatory diagrams showing the front ends of the bone cement molding device 50 and the bone cement fixation device 60, respectively, to illustrate an example of their construction. ((a) shows the front end 51 of the bone cement molding device 50, and (b) shows the front end 61 of the bone cement fixation device 60). Figure 3 This represents the bottom surface as observed from the proximal end. Figure 5This is an overhead view of the appearance and cross-sectional structure of the respective front ends. As an example, the bone cement molding device 50 has a cylindrical shaft and a prism-shaped front end 51, and the bone cement fixation device 60 has a cylindrical shaft and a prism-shaped front end 61. As shown, it is preferable that the front end 61 of the bone cement fixation device 60 has a further pyramidal portion in front of the prism, allowing for smooth insertion. The diameter d50 of the cylindrical shaft of the bone cement molding device 50 is slightly smaller than the diameter d10 of the through hole 16 of the bone cement 10, and the prism of the front end 51 is formed inside it. For example, the length d51 of the diagonal of the square in the cross-section of the regular prism is equal to or less than d50. The bone cement fixation device 60 has a cylindrical shaft and a prism-shaped front end 61. The diameter d60 of the cylindrical shaft of the bone cement fixation device 60 is slightly smaller than the diameter d10 of the through hole 16 of the bone cement 10, and a tetrahedral prism is formed on its inner side at the front end 61. For example, the length d61 of the diagonal of the square cross-section of the regular tetrahedral prism is equal to or less than d51, preferably forming a hole 2 that is approximately just embedded in the front end 51 of the bone cement molding device 50. As long as the bone cement 1 can be prevented from rotating by embedding, it is not necessary to embed it exactly, but rather to have a slight margin.

[0119] Thus, the bone cement fixation device 60 can suppress the rotation of the bone cement simply by inserting it into the hole formed in the bone cement 1.

[0120] The example given is a quadrangular prism, but other shapes are also possible. It can be a triangular prism, pentagonal prism, hexagonal prism, or even a star-shaped, plate-like, or cross-shaped plate. As long as the bone cement molding device 50 and the bone cement fixation device 60 have the same shape at their front ends, the rotational movement can be suppressed by inserting the front end 61 of the bone cement fixation device 60 into the hole 2 formed by the bone cement molding device 50. Figure 4 This is an explanatory diagram showing the bottom surface of the anterior end (star-shaped) of each of the bone cement molding device 50 and the bone cement fixation device 60 as viewed from the proximal end side, in order to illustrate other configuration examples.

[0121] in addition, Figure 5 This illustrates an example where the bone cement molding device 50 and the bone cement fixation device 60 have the same quadrangular prism shape at their front ends, and their rotational movement is suppressed by precisely fitting into each other. For example... Figure 5 As shown in the cross-sectional structure of (c), by having the front end of the bone cement fixation device 60 abut against the bottom of the hole 2, the movement of the bone cement 1 in the direction of being pulled out can also be suppressed, but it can be understood that the suppression of rotation is the main factor.

[0122] Figure 6This is an explanatory diagram showing the bottom surface and cross-sectional structure of the front ends of the bone cement molding device 50 and the bone cement fixation device 60 from a top-down view, in order to illustrate other configuration examples. The front end 51 of the bone cement molding device 50 and the front end 61 of the bone cement fixation device 60 are each prism-pyramidal, with a square pyramid formed in front of a square prism. The front end 51 of the bone cement molding device 50 forms an acute angle compared to the front end 61 of the bone cement fixation device 60, such as... Figure 6 As shown in the cross-sectional structure of (c), the front end 61 of the bone cement fixation device 60 is configured to abut against and embed itself into the sidewall of the hole 2 before reaching the bottom of the hole 2 formed by the front end 51 of the bone cement molding device 50. As a result, both rotational and withdrawal movements are suppressed.

[0123] exist Figure 5 and Figure 6 In order to aid understanding, the tip of the cone is depicted as sharp, but it is preferred that the tip be processed in a way that does not damage any part of the body tissue, nerves, or blood vessels.

[0124] Furthermore, as described later in embodiments 2 and 3, the front end 61 of the bone cement fixation device 60 does not need to be the same shape as the front end 51 of the bone cement molding device 50, as long as it can be inserted into the hole 2 formed in the bone cement 1 by the bone cement molding device 50 and suppress the rotation of the bone cement 1.

[0125] The sequence of surgery using the treatment device 100 of the present invention will be described.

[0126] Figure 10 as well as Figure 11 This is an illustrative diagram schematically showing the sequence of implantation of the internal fixation device 10 during treatment using the treatment device 100. Figure 10 This indicates the first half of the sequence. Figure 11 Indicates the second half. Figure 10 as well as Figure 11 The illustration depicts vertebroplasty, but the method of inserting the internal fixation device 10 into the vertebral body is the same in spinal fixation and vertebral body reinforcement surgery (illustration omitted). Figure 10 and Figure 11 In this diagram, the upper side of the paper is considered distal, and the lower side proximal, schematically representing the cross-section of the affected area of ​​the patient from the lateral aspect of skin 94 through pedicle 91 to vertebral body 90. The scale along the central axis (vertical to horizontal) is compressed to emphasize the depiction along the direction of the patient's body surface (horizontal to horizontal). The pedicle 91 is located on the left and right sides of vertebral body 90, thus the same procedure is performed from left to right relative to a single vertebral body 90. Figure 10 and Figure 11 It shows one side.

[0127] Step 1 ([1]): Make an incision in the skin 94 on the body surface of the patient’s back down to the subcutaneous tissue of the vertebral body 90, which is the affected area, and make a perforation so that the guide pin 40 can be inserted into the vertebral body 90 through the pedicle 91.

[0128] Step 2 ([2]): Connect the internal fixation device 10 to the driver 20, insert the inner cylinder 30 into the through hole on its inner side, and assemble it so that the front end 32 protrudes from the front end of the internal fixation device 10, so that the inner cylinder 30 covers the guide pin 40 and is inserted into the patient's body along the guide pin 40.

[0129] Step 3 ([3]): The treatment device 100, in which the internal fixation device 10, the driver 20, and the inner cylinder 30 are connected to form an integrated unit, is further pressed into the proximal direction along the guide pin 40, and the inner cylinder 30 and the front end of the internal fixation device 10 are twisted into the pedicle 91.

[0130] Step 4 ([4]): After the internal fixation device 10 is twisted in until the front end reaches near the entrance of the vertebral body 90, the guide pin 40 is removed. At this time, the notch 33 of the inner cylinder 30 contacts the front end of the internal fixation device 10 and inhibits the inner cylinder 30 from falling off naturally. However, by removing the guide pin 40, the inner cylinder 30 can be removed by bending the tongue 31 towards the central axis through the force of removing the inner cylinder 30.

[0131] Step 5 ([5]): Remove the inner cylinder 30. At this time, the driver 20 is in the state where only the head 13 of the internal fixation device 10 is inserted, so it is pre-pressed in a way that it does not fall off. Although not specifically illustrated, in this step, if necessary, a vertebral body excavation device may be introduced to excavate the vertebral body 90 in order to fill the through hole between the driver 20 and the internal fixation device 10 with cement for reinforcement.

[0132] Step 6 ([6]): The balloon catheter 70 is inserted into the vertebral body 90 through the through hole of the actuator 20 and the through hole of the internal fixation device 10, and the balloon 71 is inflated within the vertebral body 90. For example, contrast agent is injected into the balloon 71 through the balloon catheter 70, and pressure is applied to inflate it. In the case of a compression fracture of the vertebral body 90 due to osteoporosis or other reasons, the aim is to restore the vertebral body 90 to its original size.

[0133] Step 7 ([7]): Pull out the balloon catheter 70 through the through hole between the actuator 20 and the internal fixation device 10, insert the cement injector 80, and inject bone cement 1 into the vertebral body 90. For example, if the volume of cement that can be filled in one go through the cement injector 80 is set to about 1.5 ml, then, for example, in the case of vertebral body augmentation for fracture, about 10 ml of bone cement 1 is filled into the vertebral body 90 by repeatedly delivering cement about 3 times on each side, for a total of 6 to 7 times. In the case of vertebral body reinforcement surgery other than vertebral body augmentation, such as spinal fixation or artificial disc replacement, the amount of cement filled is adjusted according to the condition of the bone.

[0134] Step 8 ([8]): Pull out the cement injector 80 from the through hole between the driver 20 and the internal fixation device 10.

[0135] Step 9 ([9]): Use the actuator 20 to twist the internal fixation device 10 into the filled bone cement 1.

[0136] Step 10 (

[10] ): Insert the bone cement forming device 50 into the bone cement 1 through the through hole of the driver 20 and the through hole of the internal fixation device 10. Before the bone cement 1 has cured, a hole 2 of a specified shape is formed through the front end 51 of the bone cement forming device 50.

[0137] Step 11 (

[11] ): Remove the bone cement forming device 50 and driver 20, suture the cut skin 94, and the treatment is complete.

[0138] As described above, in the sequence of embedding bone cement 1 and performing internal fixation using the internal fixation device 10, the pre-forming of holes 2 of a predetermined shape in the bone cement 1, before it has cured, by means of the front end 51 of the bone cement molding device 50, is an important part of the present invention. Furthermore, references are made herein. Figure 10 as well as Figure 11 The described sequence of implantation of internal fixation devices is merely an example. Steps 2 ([2]) to 6 ([6]) can also be performed, for example, by inserting a thick guide pin, removing the outer tube, and inserting the internal fixation device 10 and actuator 20 in the following sequence after inserting the balloon through another outer tube to ensure the space for filling the bone cement 1.

[0139] Figure 12 This is an illustrative diagram schematically showing another example of the latter half of the sequence of implanting an internal fixation device during treatment using the therapeutic apparatus of the present invention. The first half (steps 1 to 6) to 7 are referenced in the original text. Figure 10 as well as Figure 11 The same as above.

[0140] Step 8 ([8']): Pull out the cement injector 80 from the through hole between the driver 20 and the internal fixation device 10, and insert the bone cement forming device 50. Through the front end 51 of the bone cement forming device 50, form a hole 2 of the prescribed shape in the bone cement 1.

[0141] Step 9 ([9']): Use the actuator 20 to twist the internal fixation device 10 into the filled bone cement 1.

[0142] Step 10 ([10']): Remove the bone cement molding device 50. Mold the hole 2 of the specified shape in the bone cement 1.

[0143] Step 11 (

[11] ): Remove the driver 20 (actually, together with the removal of the bone cement forming device 50 in step 10 ([10'])), suture the cut skin 94, and the treatment is complete.

[0144] Thus, the molding of the bone cement molding device 50 relative to the hole 2 of the prescribed shape in the bone cement 1 can be performed either before or after the internal fixation device 10 using the actuator 20 is inserted into the bone cement 1. Figure 11 In the sequence of inserting the internal fixation device 1 into the bone cement 1, the hole 2 of the bone cement molding device 50 is formed, thus minimizing the positional offset between the through hole 16 and the hole 2 of the internal fixation device 1. On the other hand, in Figure 12 In the sequence, before the bone cement 1 is cured, the hole 2 based on the bone cement molding device 50 is formed, after which the internal fixation device 1 can be inserted.

[0145] Next, the sequence of removing the internal fixation device 10 will be explained.

[0146] Figure 13 This is an illustrative diagram illustrating an example of the sequence of removal of the internal fixation device 10 during treatment using the therapeutic apparatus of the present invention.

[0147] Initial state (

[21] ): The bone cement 1 is internally fixed in the patient's vertebral body 90 by an internal fixation device 10 inserted from the pedicle 91. The bone cement 1 has a hole 2 of a prescribed shape formed through the through hole 16 of the internal fixation device 10.

[0148] Step 1 (

[22] ): An incision is made in the skin 94, which forms the patient's back, down to the subcutaneous tissue of the vertebral body 90, which forms the affected area, and a guide pin 40 is inserted into the through hole 16 of the internal fixation device 10 into which the pedicle 91 is inserted. Figure 13 In

[22] , the example shows the insertion of the guide pin 40 into the hole 2 formed by the bone cement 1 in the vertebral body 90, but the guide pin 40 only needs to reach the through hole 16 of the internal fixation device 10.

[0149] Step 2 (

[23] ): Guide the driver 20 along the inserted guide pin 40 through the through hole of the driver 20, thereby guiding the driver 20 to the internal fixation device 10, so that the front end of the driver 20 is embedded in and connected to the head (connecting part) 13 of the internal fixation device 10.

[0150] Step 3 (

[24] ): Insert the bone cement fixation device 60 into the through hole of the driver 20, which is connected to the internal fixation device 10 via the driver 20, and guide it into the vertebral body 90. Insert the front end 61 into the hole 2 of the bone cement 1. The shape of the front end 61 of the bone cement fixation device 60 is the same as the shape of the hole 2 of the bone cement 1, which allows it to be inserted, thereby suppressing rotational movement. In addition, the movement in the direction of pulling out the bone cement 1 can be suppressed by the front end of the bone cement fixation device 60 abutting against the bottom of the hole 2.

[0151] Step 4 (

[25] ): With the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1 and rotation and movement in the extraction direction suppressed, the internal fixation device 10 is removed by pressing with the handle 62 while rotating the actuator 20, without rotating the bone cement fixation device 60. As long as the thread 15 provided on the distal side of the internal fixation device 10 taps the pedicle 91 during insertion, the internal fixation device 10 can be pushed in the extraction direction by rotating in the opposite direction to the insertion, thereby smoothly removing the internal fixation device 10. Alternatively, assuming that the internal fixation device 10 does not have a threaded structure, movement in the direction of extraction of the bone cement 1 can be suppressed by the bone cement fixation device 60, and the internal fixation device 10 can be removed by tapping using a mechanical device or instrument such as forceps that hold the actuator 20 or the internal fixation device 10.

[0152] Step 5 (

[26] ): Remove the bone cement fixation device 60 (actually, together with the internal fixation device 10 and the actuator 20 of step 4 (

[25] ), suture the cut skin 94, and the treatment is completed. In cases where the front end of the bone cement fixation device 60 and the hole 2 are both prisms or the like, it can be removed simply by pulling it out.

[0153] Figure 14 This is an illustrative diagram illustrating other examples of the sequence of removal of internal fixation devices 10.

[0154] Initial state (

[31] ): with Figure 13 The initial state shown (

[21] ) is the same, in which the bone cement 1 is internally fixed in the patient's vertebral body 90 by an internal fixation device 10 inserted from the pedicle 91. The bone cement 1 has a hole 2 of a prescribed shape formed through the through hole 16 of the internal fixation device 10.

[0155] Step 1 (

[32] ): The skin 94, which is the surface of the patient's spine, is cut open down to the subcutaneous tissue of the vertebral body 90, which is the affected area, and a perforation is made, replacing... Figure 13 The guide pin 40 shown in

[22] allows the cement fixation device 60 to be directly inserted into the through hole 16 of the internal fixation device 10. More specifically, the front end of the cement fixation device 60, which is inserted into the through hole of the actuator 20, is guided into the through hole 16 of the internal fixation device 10, which is inserted into the pedicle 91. In the cement fixation device 60, it is more preferable that the handle 62 is detachable. With the handle 62 removed, the cement fixation device 60 is inserted into the through hole 16 of the internal fixation device 10 using the same method as the guide pin 40. The actuator 20 is guided from the distal end of the cement fixation device 60 along the axis of the cement fixation device 60 to the internal fixation device 10, and can be connected to the head (connecting part) 13 of the internal fixation device 10.

[0156] Step 2 (

[33] ): The actuator 20 is pressed deeper into the bone cement fixation device 60 and connected to the head (connecting part) 13 of the internal fixation device 10. The bone cement fixation device 60 is inserted further deeper, and the front end 61 of the bone cement fixation device 60 is inserted into the hole 2 of the bone cement 1. The insertion of the actuator 20 and the bone cement fixation device 60 can be arbitrary, either one can be performed first, or they can be performed simultaneously. The front end 61 of the bone cement fixation device 60 and the hole 2 of the bone cement 1 are machined to the same shape, and the rotational movement is suppressed by embedding. In addition, the movement in the direction of pulling out the bone cement 1 is suppressed by the front end of the bone cement fixation device 60 abutting against the bottom of the hole 2.

[0157] Step 3 (

[34] ): With the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1 and rotation and movement in the extraction direction suppressed, the internal fixation device 10 is removed by pressing with the handle 62 while rotating the actuator 20, without rotating the bone cement fixation device 60. As long as the thread 15 provided on the distal side of the internal fixation device 10 taps the pedicle 91 during insertion, the internal fixation device 10 can be pushed in the extraction direction by rotating in the opposite direction to the insertion, thereby smoothly removing the internal fixation device 10. Alternatively, assuming that the internal fixation device 10 does not have a threaded structure, the movement of the bone cement 1 in the extraction direction can be suppressed by the bone cement fixation device 60, and the internal fixation device 10 can be removed by tapping using a mechanical device or instrument such as forceps that hold the actuator 20 or the internal fixation device 10.

[0158] Step 4 (

[35] ): Remove the handle 62 from the bone cement fixation device 60 and remove the removed internal fixation device 10 and actuator 20.

[0159] Step 5 (

[36] ): Remove the cement fixation device 60 and suture the cut skin 94, thus ending the treatment. In cases where the anterior end 61 of the cement fixation device 60 strongly engages the hole 2 of the cement 1, the handle 62 may be installed and removed. However, in cases where it is only embedded, the internal fixation device 10 and the actuator 20 may not be removed in advance in step 4 (

[35] ), and the cement fixation device 60, the internal fixation device 10, and the actuator 20 may be removed together at the same time.

[0160] Step 3 (

[34] ) and Step 4 (

[35] ) and Figure 13 Step 4 (

[25] ) in the example shown is the same as step 5 (

[26] ). In step 1, the bone cement fixation device 6 is inserted directly into the internal fixation device 10 that should be removed without using the guide pin 40, thus reducing the sequence.

[0161] In this sequence, threads or grooves are formed at the front end of the internal fixation device 10, and insertion and removal of the bone cement 1 are assumed to be performed by rotating and reversing the threads. However, this sequence can also be applied when the internal fixation device 10 is not formed at the front end, and insertion and removal of the bone cement 10 are performed simply by pressing and pulling. In this case, compared to the action of the bone cement fixation device 60 inhibiting the rotation direction of the bone cement 1, the action in the same direction as the removal of the internal fixation device 10 can also be inhibited.

[0162] [Implementation Method 2]

[0163] In Embodiment 1, the solution involves pre-forming a hole 2 of a predetermined shape in the bone cement 1 using the front end 51 of the bone cement molding device 50, and then inserting the front end 61 of the bone cement fixation device 60 of the same shape into it, thereby suppressing the rotation of the bone cement 1. However, the front end 61 of the bone cement fixation device 60 and the front end 51 of the bone cement molding device 50 do not need to be of the same shape; it is sufficient that the front end 51 of the bone cement molding device 50 is inserted into the formed hole 2 to suppress the rotation of the bone cement 1.

[0164] Figure 15 This is an explanatory diagram showing the front ends of the bone cement molding device 50 and the bone cement fixation device 60, which are examples of the treatment devices according to the second embodiment of the present invention. The diagram shows the bottom surface as viewed from the proximal end side (bottom surface side). (a) is the front end 51 of the bone cement molding device 50. Presented with… Figure 3The bone cement molding device 50 shown in Embodiment 1 has the same shape, having a cylindrical shaft and a prism-shaped front end 51. The bone cement fixation device 60 also has a cylindrical shaft and a prism-shaped front end 61. The diameter d50 of the cylindrical shaft of the bone cement molding device 50 is slightly smaller than the diameter d10 of the through hole 16 of the bone cement 10, and the prism-shaped front end 51 is formed on its inner side. For example, the length d51 of the diagonal of the square cross-section of a regular prism is equal to or less than d50.

[0165] (b) is the front end portion 61 of the bone cement fixation device 60. The bone cement fixation device 60 has a cylindrical shaft and a columnar front end portion 61 with a cross-shaped cross section. The diameter d60 of the cylindrical shaft of the bone cement fixation device 60 is slightly smaller than the diameter d10 of the through hole 16 of the bone cement 10, and the front end portion 61 is formed inside it. For example, the width d61 of the cross section is equal to or less than d51, and preferably the front end portion 51 of the bone cement molding device 50 is approximately just enough to fit into the formed hole 2. As long as the bone cement 1 can be prevented from rotating by fitting, it is not necessary to fit exactly and have a little leeway.

[0166] exist Figure 15 The examples used are a quadrangular prism and a cross, but it can also be a straight line with the diagonal of the quadrangular prism embedded in it. In addition, there are various variations, such as the front end 51 of the bone cement molding device 50 being a hexagonal prism, the front end 61 of the bone cement fixation device 60 being a triangular prism, and the front end of the cross being a cone.

[0167] [Implementation Method 3]

[0168] Further variations will be described. This embodiment uses a cylindrical front end 51 of the bone cement forming device 50. For example, assuming that when the internal fixation device 10 is implanted into the vertebral body, there is no special bone cement forming device 50, but a guide pin, a cylindrical bone cement injector, a cement pressurizer, etc., are used instead of the pre-formed hole 2. Since the hole 2 is circular, there is no option to simply insert a shape for the front end 61 of the bone cement fixation device 60 that can suppress the rotation of the bone cement 1.

[0169] Figure 16 This is an explanatory diagram showing the appearance of the front end portions of the bone cement molding device 50 and the bone cement fixation device 60 from a top-down view, illustrating an example of the configuration of a treatment device according to the third embodiment of the present invention. The front end portion 51 of the bone cement molding device 50 is as follows... Figure 16 (a) shows a cylinder. The anterior end 61 of the bone cement fixation device 60 is as shown. Figure 16As shown in (b), the device has threads that tap and are inserted into the hole 2 formed by the front end 51 of the bone cement molding device 50, and a blunt tip that contacts the bottom of the hole 2 to stop insertion. More specifically, the outer periphery of the cylindrical portion of the front end 61 of the bone cement fixation device 60 is smaller than the diameter of the hole 2, and the outer periphery of the apex of the thread used for tapping is equal to or larger than the diameter of the hole 2. Theoretically, this diameter needs to be larger than the diameter of the hole 2 for tapping, but in reality, when the hole 2 is being formed, the bone cement 1 is not fully cured, and it cannot be said that there is absolutely no possibility that the hole 2 will become smaller after the bone cement molding device 50 is removed. Therefore, it should also be considered that the outer periphery of the apex of the thread used for tapping the front end 61 of the bone cement fixation device 60 is equal to the diameter of the hole 2.

[0170] Therefore, other bone cement fixation devices 60 capable of suppressing the rotation of bone cement 1 can be provided. For example, as an example of bone cement forming device 50, a hole 2 is pre-formed in bone cement 1 using guide pin 40 and bone cement injector 80, and the front end 61 of bone cement fixation device 60 is pre-formed with threads of the same thickness as guide pin 40 or with an outer diameter greater than that of guide pin 40. Thus, while bone cement fixation device 60 is screwed in and bone cement 1 is fixed, the actuator 20 can be operated to reverse and remove the internal fixation device 10.

[0171] Figure 17 This is an explanatory diagram showing the appearance and cross-sectional structure of the front ends of the bone cement molding device 50 and the bone cement fixation device 60 from an overhead view, in order to show other configuration examples. Figure 16 The front end 51 of the bone cement molding device 50 and the front end 61 of the bone cement fixation device 60 shown are both cylindrical. In contrast, in... Figure 17 In the example shown, the front end 51 of the bone cement molding device 50 and the front end 61 of the bone cement fixation device 60 are both cylindrical-conical. A cylindrical-conical shape has a side profile that slopes in a manner that decreases in diameter as the cylinder approaches the front end; as shown, it can be a truncated cone or a regular cone. The outer peripheral surface of the front end 51 of the bone cement molding device 50 is smooth, and threaded teeth for tapping are formed on the outer peripheral surface of the front end 61 of the bone cement fixation device 60. Figure 17 As shown in (c), the hole 2 formed by the front end 51 of the bone cement forming device 50 narrows towards the bottom, so the threads for tapping formed on the outer periphery of the front end 61 of the bone cement fixing device 60 are turned into the sidewall of the hole 2. Before the front end 61 reaches the bottom of the hole 2, the front end 61 of the bone cement fixing device 60 is inserted and stopped in the hole 2. The bone cement fixing device 60 can suppress the force in the rotational direction and the pull-out direction of the bone cement 1.

[0172] exist Figure 17 In this design, the diameter of the bottom surface (the side in contact with the shaft) of the front end 51 of the bone cement molding device 50 and the front end 61 of the bone cement fixation device 60 is depicted as smaller than that of the shaft, but it can also be the same diameter as the shaft. The outer diameter of the thread teeth formed on the front end 61 of the bone cement fixation device 60 needs to be smaller than the diameter of the through hole 16 of the internal fixation device 10.

[0173] Figure 18 This is an explanatory diagram illustrating an example of the sequence of removal of the internal fixation device 10 during treatment using the treatment device of the third embodiment.

[0174] Initial state (

[41] ): The bone cement 1 is internally fixed in the patient's vertebral body 90 by an internal fixation device 10 inserted from the pedicle 91, which supports the bone cement 1. A hole 2 is formed in the bone cement 1 through a through hole 16 in the internal fixation device 10. Figure 18 In this context, hole 2 is assumed to be a cylindrical hole formed by a cylinder, but as mentioned above, the same applies even if it is a cylindrical cone (frustum or cone) instead of a cylinder.

[0175] Step 1 (

[42] ): An incision is made in the skin 94, which forms the surface of the patient's spine, down to the subcutaneous tissue of the vertebral body 90, which forms the affected area, and a guide pin 40 is inserted into the through hole 16 of the internal fixation device 10 into which the pedicle 91 is inserted. Figure 18 In

[42] , the example shows the insertion of the guide pin 40 into the hole 2 formed by the bone cement 1 in the vertebral body 90, but the guide pin 40 only needs to reach the through hole 16 of the internal fixation device 10.

[0176] Step 2 (

[43] ): Guide the driver 20 along the inserted guide pin 40 through the through hole of the driver 20, thereby guiding the driver 20 to the internal fixation device 10, and inserting the front end of the driver 20 into the head (connecting part) 13 of the internal fixation device 10 and connecting it thereto.

[0177] Step 3 (

[44] ): Insert the bone cement fixation device 60 into the through hole 16 of the internal fixation device 10 and the driver 20, which are connected to the internal fixation device 10 via the driver 20, and guide it into the vertebral body 90. Insert the front end 61 into the hole 2 of the bone cement 1. The front end 61 of the bone cement fixation device 60 is provided with a thread for tapping. Therefore, while tapping the hole 2 of the bone cement 1, the device is advanced and stopped when the front end 61 reaches the bottom of the hole 2. Then, while inhibiting the driver 20, the driver 20 is tapped in a way that the bone cement 1 does not rotate. The tapping generates a force to remove the internal fixation device 10 in the opposite direction to the force that rotates the bone cement 1, thereby creating a gap between the internal fixation device 10 and the bone cement 1, which allows for removal.

[0178] Step 4 (

[45] ): With the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1 and rotation suppressed, the internal fixation device 10 is removed by pressing with the handle 62 while rotating the actuator 20, without rotating the bone cement fixation device 60. As long as the thread 15 provided on the distal side of the internal fixation device 10 taps the pedicle 91 during insertion, the internal fixation device 10 can be pushed in the direction of removal by rotating in the opposite direction to the insertion, thereby smoothly removing the internal fixation device 10. For example, if the bone cement fixation device 60 is rotated clockwise as it moves toward the bottom of the hole 2, the actuator 20 can be rotated counterclockwise while maintaining the clockwise force, thereby removing the internal fixation device 10. Even if the bone cement 1 is to rotate counterclockwise by a force that causes the actuator 20 to rotate counterclockwise, the rotation of the bone cement 1 can be suppressed by a force that causes the bone cement fixation device 60 to rotate clockwise.

[0179] Step 5 (

[46] ): Remove the cement fixation device 60 and suture the incised skin 94, thus ending the treatment. The anterior end 61 of the cement fixation device 60 is rotated in the opposite direction to the insertion, thereby allowing it to be removed. At this time, although it is impossible to apply a force to inhibit the rotation of the cement 1, the insertion of the cement fixation device 60 is the tapping of the cement 1, which has been completely cured over a long period of time, so it can be removed with a weaker force without causing the cement 1 to rotate. In addition, when the bonding between the internal fixation device 10 and the cement 1 is slightly relaxed, the cement fixation device 60 also immediately relaxes, thereby preventing the cement fixation device 60 from being forcefully embedded and unable to fall out.

[0180] In the event that the bone cement 1 separates from the surrounding body tissue and simply rotates, this can be resolved by flexibly using two types of bone cement fixation devices 60: one with a relatively large outer diameter threaded end 61 for forming the tapped groove, and the other with a smaller outer diameter threaded end 61. The tapped groove is formed using the bone cement fixation device 60 with the larger outer diameter threaded end, and then the bone cement fixation device 60 with the smaller outer diameter threaded end is inserted along the formed tapped groove to the bottom of the hole 2. To suppress the rotation of the bone cement 1 during removal of the internal fixation device 10, a bone cement fixation device 60 with a smaller outer diameter threaded end is used. This bone cement fixation device 60 has a smaller outer diameter threaded end and is inserted only along the pre-formed tapped groove, so it can be pulled out with less force if reversed.

[0181] Figure 19 This is an explanatory diagram illustrating other examples of the sequence of removal of the internal fixation device 10 during treatment using the treatment device of this third embodiment.

[0182] Initial state (

[51] ): with Figure 18

[41] Similarly, in the patient's vertebral body 90, the bone cement 1 is internally fixed by an internal fixation device 10 inserted from the pedicle 91. A hole 2 is formed in the bone cement 1 through a through hole 16 in the internal fixation device 10. Figure 19 It is assumed that hole 2 is a cylindrical hole formed by a cylinder, but the same applies even if it is a cylindrical cone instead of a cylinder.

[0183] Step 1 (

[52] ): The skin 94, which is the body surface of the patient's spine, is cut open down to the subcutaneous tissue of the vertebral body 90, which is the affected area, and a perforation is made, replacing the previous step. Figure 18 The guide pin 40 of

[42] is used to insert the bone cement fixation device 60 into the through hole 16 of the internal fixation device 10 that has been inserted into the pedicle 91. With the handle 62 removed from the bone cement fixation device 60, first insert the bone cement fixation device 60 into the through hole 16 of the internal fixation device 10, or with the handle 62 still installed, pre-insert the driver 20 from the front end of the bone cement fixation device 60, and press it with your hand while inserting the front end 61 of the bone cement fixation device 60 into the through hole 16 of the internal fixation device 10.

[0184] Step 2 (

[53] ): Install the handle 62 on the bone cement fixation device 60, twist the front end 61 into the hole 2, so that the through hole of the driver 20 is along the inserted bone cement fixation device 60, guide the driver 20 to the internal fixation device 10, and insert the front end of the driver 20 into the head (connecting part) 13 of the internal fixation device 10 for connection. The twisting of the front end 61 of the bone cement fixation device 60 into the hole 2 can also be performed after the driver 20 is connected to the internal fixation device 10.

[0185] Step 3 (

[54] ): With the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1 and rotation suppressed, the internal fixation device 10 is removed by pressing with the handle 62 while rotating the actuator 20, without rotating the bone cement fixation device 60. As long as the thread 15 provided on the distal side of the internal fixation device 10 taps the pedicle 91 during insertion, the internal fixation device 10 can be pushed in the direction of removal by rotating in the opposite direction to the insertion, thereby smoothly removing the internal fixation device 10. For example, if the bone cement fixation device 60 is rotated clockwise as it moves toward the bottom of the hole 2, the actuator 20 is rotated counterclockwise while maintaining the clockwise force, thereby removing the internal fixation device 10. Even if the bone cement 1 intends to rotate counterclockwise by a force that causes the actuator 20 to rotate counterclockwise, the rotation of the bone cement 1 can be suppressed by a force that causes the bone cement fixation device 60 to rotate clockwise.

[0186] Step 4 (

[55] ): Remove the bone cement fixation device 60 and suture the cut skin 94, thus ending the treatment.

[0187] As mentioned above, instead Figure 18 The guide pin 40 is used with a bone cement fixation device 60, which simplifies the removal sequence. In this case, it is more preferable that the handle 62 can be attached and detached from the bone cement fixation device 60.

[0188] [Implementation Method 4]

[0189] Figure 20 This is an explanatory diagram schematically illustrating an example of the configuration of the bone cement molding device 50 and the actuator 20 of the therapeutic apparatus according to the fourth and fifth embodiments of the present invention.

[0190] The fourth implementation method is from a reference. Figure 16 In the modified embodiment of the third embodiment described herein, not only the bone cement fixation device 60 but also the bone cement molding device 50 has threads that are tapped and turned into the sidewall of the hole 2. This allows for pre-drilling grooves into the sidewall of the hole 2. When the internal fixation device 10 needs to be removed, the tapped threads of the bone cement fixation device 60 are turned into the grooves pre-formed in the hole 2, thus allowing for removal with less force. Furthermore, removing the bone cement fixation device after removing the internal fixation device becomes easier.

[0191] Figure 20 The description also combines the fifth embodiment described later, but it is not necessary to combine them to implement it.

[0192] [Implementation Method 5]

[0193] In the treatment device 100 of embodiment 5, the bone cement molding device 50 can also be inserted into the through hole of the actuator 20 connected to the internal fixation device 10, such as Figure 20 As illustrated, the device is configured to protrude a predetermined length (e.g., about 1 cm) from the front end of the internal fixation device 10. This allows the bone cement forming device 50 to be inserted to form the hole 2 while the actuator 20 is connected to the internal fixation device 10, thus reducing the number of procedures required, as will be described later.

[0194] At this point, it is even more preferable if the bone cement forming device 50 is configured to be detachable from the actuator 20. This is because it allows for selective and flexible use of either simultaneous or separate forming of the hole 2 and insertion of the internal fixation device 10 into the bone cement 1.

[0195] The bone cement forming device 50 and the actuator 20 can, for example, be configured with threaded structures on their distal ends, and integrated by screwing and connecting. Other connection methods are also possible. For example, it can be a connector structure that will not detach unless pulled forcefully, or a locking structure that maintains the connection. Thus, the operability of the therapeutic device 100 can be improved when forming the hole 2 and inserting the internal fixation device 10 into the bone cement 1 simultaneously. This is because, as shown in the figure, the handle 27 of the actuator 20 and the handle 52 of the bone cement forming device 50 are integrated, making it easy to hold with one hand.

[0196] Figure 21 This is an explanatory diagram schematically showing the latter half of the sequence of implanting the internal fixation device 10 during treatment using the treatment device 100 of the fifth embodiment. The first half of the sequence of implanting the internal fixation device 10 is the same as the referenced portion. Figure 10 Steps 1 ([1]) to 6 ([6]) have been explained similarly, therefore the explanation is omitted. Furthermore, Figure 21 also with Figure 10 as well as Figure 11 Similarly, using the upper side of the paper as the distal view and the lower side as the proximal view, this schematically illustrates the cross-section of the patient's affected area from the lateral side of skin 94 through pedicle 91 to vertebral body 90. The scale along the central axis (vertical to horizontal) is compressed, emphasizing the depiction along the direction of the patient's body surface (horizontal to horizontal). The pedicle 91 is located on the left and right sides of vertebral body 90, therefore, the same procedure is performed from left to right relative to a single vertebral body 90. Figure 21 It shows one side.

[0197] Step 7 (

[67] ): Pull out the balloon catheter 70 from the through hole between the driver 20 and the internal fixation device 10, insert the cement injector 80, and inject bone cement 1 into the vertebral body 90.

[0198] Step 8 (

[68] ): Pull out the cement injector 80 from the through hole between the driver 20 and the internal fixation device 10, and insert the bone cement forming device 50 into the through hole of the driver 20, so that its front end 51 protrudes from the front end of the internal fixation device 10 into the bone cement 10. At this time, Figure 21 Described as a assumption Figure 20 The bone cement molding device 50 shown in the example is not limited to this type of bone cement molding device 50. The front end 51 can be, for example, cylindrical, cylindrical-conical (frustum or cone), and the presence or absence of thread teeth for tapping on the outer peripheral surface is also arbitrary.

[0199] Step 9 (

[69] ): Using the actuator 20, the internal fixation device 10 is twisted into the filled bone cement 1. At the same time, the bone cement forming device 50 is also inserted into the bone cement 1, forming the hole 2. Figure 21As illustrated, it is more preferable if the bone cement molding device 50 is integrated with the actuator 20 via a threaded structure at its distal end. However, this is not a limitation.

[0200] Step 10 (

[70] ): Remove the driver 20, suture the cut skin 94, and the treatment is complete.

[0201] As mentioned above, with references Figure 11 Compared to the order described, the procedure can be shortened by simultaneously inserting the internal fixation device 10 and forming the hole 2 of the bone cement forming device 50.

[0202] [Implementation Method 6]

[0203] In the embodiments described above, from the first to the fifth, a through hole may be provided in the bone cement fixation device 60 for the guide pin to pass through. This allows the bone cement fixation device 60 to be guided along the guide pin 40 pre-inserted into the affected area to the hole 2 of the bone cement 1 in the affected area.

[0204] Figure 22 This is an explanatory diagram illustrating an example of the sequence of removal of the internal fixation device 10 during treatment using the treatment device according to the sixth embodiment of the present invention.

[0205] Initial state (

[71] ): The bone cement 1 is internally fixed in the patient's vertebral body 90 by an internal fixation device 10 inserted from the pedicle 91. The bone cement 1 forms a hole 2 of a prescribed shape through a through hole 16 in the internal fixation device 10.

[0206] Step 1 (

[72] ): Make a cut from the skin 94 on the body surface of the patient’s back down to the subcutaneous tissue of the vertebral body 90, which is the affected area, and make a perforation. Insert a guide pin 40 into the through hole 16 of the internal fixation device 10 inserted into the pedicle 91, so that its front end reaches the hole 2 formed by the bone cement 1 in the vertebral body 90.

[0207] Step 2 (

[73] ): Guide the bone cement fixation device 60 and the actuator 20 together along the guide pin 40 toward the hole 2 formed in the bone cement 1.

[0208] Step 3 (

[74] ): Insert the bone cement fixation device 60 into the hole 2, so that the actuator 20 is connected to the internal fixation device 10 at the head 13, and remove the guide pin 40.

[0209] Step 4 (

[75] ): With the front end 61 of the bone cement fixation device 60 inserted into the hole 2 of the bone cement 1 and rotation and / or movement in the extraction direction suppressed, the internal fixation device 10 is removed by pressing with the handle 62 while rotating the actuator 20, so that the bone cement fixation device 60 is rotated without being pulled out. Similar to the other embodiments described above, as long as the thread 15 provided on the distal side of the internal fixation device 10 taps the pedicle 91 during insertion, the internal fixation device 10 can be given a pushing force in the extraction direction by rotating in the opposite direction to the insertion, thereby smoothly removing the internal fixation device 10. Alternatively, assuming that the internal fixation device 10 does not have a threaded structure, the movement in the direction of pulling out the bone cement 1 can be suppressed by the bone cement fixation device 60, and the internal fixation device 10 can be removed by tapping using a mechanical device or instrument such as a forceps holding the actuator 20 or the internal fixation device 10.

[0210] Step 5 (

[76] ): Remove the bone cement fixation device 60, suture the cut skin 94, and the treatment is complete.

[0211] As described above, a through hole is pre-set in the cement fixation device 60 for the guide pin to pass through, thereby allowing the cement fixation device 60 to be easily and correctly guided to the hole 2 formed by the cement molding device 50, thus enabling the removal of the internal fixation device 10 to proceed smoothly.

[0212] The invention made by the inventor has been specifically described above based on the embodiments, but the invention is not limited thereto, and it goes without saying that various modifications can be made without departing from its spirit.

[0213] <Potential for Industrial Use>

[0214] This invention relates to a cylindrical internal fixation device for medical use, and in particular, it can be appropriately used in internal fixation surgery of the vertebral body as the affected area.

[0215] Symbol explanation:

[0216] 1 Bone cement; 2 Hole; 10 Internal fixation device; 12 Shaft; 13 Head (connection to actuator); 14 Groove; 15 Thread; 16 Through hole; 17 Inclined part; 20 Actuator; 25 Connection to inner cylinder; 26 External thread; 27 Handle of actuator; 30 Inner cylinder; 31 Tongue of inner cylinder; 32 Front end of inner cylinder; 33 Notch; 34 Thread at the front end of inner cylinder; 35 Connection to actuator; 36 Internal thread; 37 Handle of inner cylinder; 40 Guide pin; 50 Bone cement forming device; 51 Front end of bone cement forming device; 52 Handle; 53 Connecting part; 54 Thread; 60 Bone cement fixation device; 61 Front end of bone cement fixation device; 62 Handle; 64 Through hole; 70 Balloon catheter; 71 Balloon; 80 Cement injector; 90 Vertebral body; 91 Pedicle; 92 Vertebral arch; 93 Spinal canal; 94 Skin; 100 Treatment device.

Claims

1. A therapeutic device comprising an internal fixation device for internal fixation by inserting into bone cement pre-filled in the vertebral body and supporting the pedicle for internal fixation, a bone cement molding device, and a bone cement fixation device. The therapeutic device is characterized in that... The internal fixation device has a through hole along a central axis from the head to the anterior end, allowing for insertion and removal relative to the bone cement along the central axis. The bone cement molding device is inserted into the bone cement through the through hole of the internal fixation device to form a hole of a specified shape. The bone cement fixation device has a front end that is inserted into the hole. Bone cement with the hole formed therein is inserted through the through hole of the internal fixation device. The front end is inserted into the hole, thereby inhibiting the rotation of the bone cement about the central axis and / or the movement in the pull-out direction.

2. The therapeutic device according to claim 1, characterized in that, The front end of the bone cement molding device is cylindrical or cylindrical-conical in shape with a diameter that decreases towards the front end. The bone cement fixation device has threads that tap and are twisted into the sidewalls of the hole.

3. The therapeutic device according to claim 2, characterized in that, The bone cement molding apparatus has threads that tap and are twisted into the sidewalls of the hole.

4. The therapeutic device according to claim 2, characterized in that, The therapeutic device further includes a actuator. The internal fixation device can be connected to the actuator at the head. The actuator has a through hole that communicates with the internal fixation device when connected to it, thereby allowing the front ends of the bone cement forming device and the bone cement fixation device to pass through.

5. The therapeutic device according to claim 4, characterized in that, The bone cement molding device is inserted into the through hole of the actuator connected to the internal fixation device and protrudes a specified length from the front end of the internal fixation device.

6. The therapeutic device according to claim 5, characterized in that, The bone cement molding apparatus and the driver can be detachably connected.

7. The therapeutic device according to claim 6, characterized in that, The actuator has a threaded structure at its distal end that allows it to connect with the bone cement molding device.

8. The therapeutic device according to claim 2, characterized in that, The bone cement fixation device has a detachable handle and shaft portion.

9. The therapeutic device according to any one of claims 2 to 8, characterized in that, The treatment device further includes a guide pin, and the bone cement fixation device has a through hole through which the guide pin passes.

10. The therapeutic device according to claim 1, characterized in that, The front end of the bone cement molding device is prismatic or prismatic-pyramidal in cross-section, with the cross-section decreasing in size towards the front end. The bone cement fixation device has a front end shape that abuts against the sidewall of the hole to inhibit rotation of the bone cement.

11. The therapeutic device according to claim 10, characterized in that, The bone cement fixation device has a detachable handle and shaft portion.

12. The therapeutic apparatus according to claim 10 or 11, characterized in that, The therapeutic device further includes a actuator. The internal fixation device can be connected to the actuator at the head. The actuator has a through hole that communicates with the internal fixation device when connected to the internal fixation device, thereby allowing the front end portion of the bone cement molding device and the bone cement fixation device to pass through.

13. The therapeutic apparatus according to any one of claims 10 to 12, characterized in that, The treatment device further includes a guide pin, and the bone cement fixation device has a through hole through which the guide pin passes.

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