Therapeutic instrument

Abstract

The present invention is a therapeutic instrument including a vertebral body perforation guide and a vertebral body processing tool, and is configured as follows. The vertebral body perforation guide is a hollow cylinder running along a central axis, and comprises a distal end spatula portion, an intermediate portion, and a terminus portion, in the stated order from the proximal side along the central axis. The distal end spatula portion opens in a direction perpendicular to the central axis. The terminus portion has an opening in a direction perpendicular to the central axis. The inner diameter of the intermediate portion in the up-down direction is greater than the inner diameter of the distal end spatula portion. The vertebral body processing tool is rod-shaped and has a curved portion that curves downward along the central axis; when the foregoing is inserted into the vertebral body perforation guide from the terminus portion along the central axis and has passed the intermediate portion along the central axis, the distal end protrudes out from the opening of the distal end spatula portion. Provided is a safe therapeutic instrument that, in percutaneous vertebroplasty for a fracture or surgery to preventatively reinforce a vertebral body with bone cement, makes it possible to accurately excavate an intended location to every corner within the vertebral body while also minimizing incision in the skin.

Description

Treatment instrument

[0001] The present invention relates to a treatment instrument for the spine (also referred to as "vertebral body") filled with bone cement, and in particular, it can be suitably used for surgeries that stabilize and reinforce the spine before treating fractures or inserting artificial intervertebral discs.

[0002] One of the treatment methods for the spine is a treatment method called percutaneous vertebroplasty. This is a surgery in which a balloon catheter is inserted into the fractured site, the balloon is expanded to secure a cement filling space, and then bone cement is filled.

[0003] Patent Document 1 discloses a method for determining the size and / or arrangement of screws and instruments in the pedicle of a selected spinal region during surgery. A three-dimensional image of the original size of the vertebra in the spinal region is generated, the vertebra of the three-dimensional image is cut out according to the thickness of the cortical wall selected by the surgeon, the narrow part of each pedicle is determined, and then the ideal diameter, length and / or trajectory of the pedicle screw or instrument are determined.

[0004] Patent Document 2 discloses a method and device for treating disc diseases. The method for performing transpedicular discectomy disclosed in the same patent document includes the steps of forming a transpedicular channel from the pedicle of the vertebra to the vertebral body, inserting a flexible cone through the transpedicular channel, forming an angle of about 90 degrees with the flexible cone, and using the flexible cone to penetrate the vertebral body to form a channel into the intervertebral disc, and the step of removing a part of the intervertebral disc with a laser device.

[0005] Japanese Patent Application Laid-Open No. 2008-537496, Japanese Patent Application Laid-Open No. 2007-526001

[0006] The biggest drawback of percutaneous vertebroplasty is that, in a certain percentage of cases, the adjacent vertebrae fracture after surgery (adjacent vertebral fracture). Recent studies are revealing the risk of adjacent vertebral fracture after surgery. However, there is no optimal treatment device to reinforce and stabilize the adjacent vertebrae and intervertebral space in advance to reduce the risk of adjacent vertebral fracture during the initial percutaneous vertebroplasty. The reasons for this are as follows: First, if a cavity is created in the adjacent vertebra using a balloon catheter to fill it with bone cement, similar to the fractured vertebra, there is a risk of destroying the cortical bone (shell) of the adjacent vertebra due to high-pressure balloon expansion. Destroying the cortical bone (shell) is the exact opposite of reinforcing the vertebra, which defeats the purpose. Second, even if it were possible to expand the balloon catheter in the center of the vertebra without destroying the cortical bone (shell) and fill the center with bone cement, it would be difficult to safely fill the bone cement to the intended location in every corner of the normal vertebra. The third point is that if bone cement is injected into the vertebral bone using a syringe or similar device without adequately creating a cavity for filling with bone cement, due to the biological structure and characteristics, the bone cement may not fill the intended location in the vertebral body. Instead, the liquid bone cement may enter the bloodstream from within the bone, flow into the adjacent vena cava, and then into the pulmonary artery, where it hardens and can cause a fatal pulmonary embolism. This has been reported in previous literature.

[0007] The inventors of this invention have identified a problem in the lack of a suitable treatment instrument that can accurately excavate the intended area, even in the corners of the vertebral body, as a pretreatment for reinforcing the vertebral body by replacing its internal structure with bone cement without damaging the normal shape of the spine. This problem can be discussed in the following three parts.

[0008] The first challenge is that it is anatomically difficult to accurately perforate and excavate every corner near the lower endplate of the vertebral body to form a cavity.

[0009] Patent Document 1 discloses a straight cannula having a groove, which enables the introduction and insertion of a balloon catheter that is pre-bent or can be manually bent to a desired angle, and allows the balloon to be positioned in the center of the vertebral body (see paragraph 0124, Figures 38a-b, 39a-b, etc.).

[0010] However, this technique is intended to position the balloon in the center of the vertebral body and cannot be applied to instruments for precisely drilling into the intended location throughout the vertebral body. This is because, due to the straight shape of the cannula, it is impossible to accurately guide the tip of the drilling instrument, which is the drilling point, to the intended location. Although it is said that it can be manually bent to the desired angle, the bending point is only the proximal end of the groove in the straight cannula, and beyond the pedicle, it can only be moved in a straight line along the cannula inside the vertebral body. Therefore, it is anatomically difficult to accurately perforate and drill into the entire area near the lower endplate of the vertebral body and form a cavity.

[0011] Here, "proximal" refers to the side closer to the midline of the patient's body, while "distal" refers to the side further away; these are medical terms. Furthermore, "cement" refers to medical bone cement, such as calcium phosphate and polymethyl methacrylate, which hardens over time.

[0012] The second challenge is the lack of minimally invasive treatment devices that can solve the aforementioned problems.

[0013] As shown in Figure 38b of Patent Document 1, a problem arises because the surgeon's hands, holding the cannula 600 and balloon catheter 704, are wide open, requiring a large incision in the patient's skin. Furthermore, the vertebral arch structure, where the cannula is inserted, must be thoroughly exposed during surgery. That is, a skin incision and surgical deployment must be performed that allows for thorough exposure to the deepest part of the groove (towards the spine). Therefore, even if the above problems can be solved, it cannot be considered a minimally invasive treatment device.

[0014] The third problem is the lack of a safe treatment device that can solve the first and second problems described above. The flexible drill disclosed in Patent Document 2 involves inserting the flexible drill into the vertebral body through a straight retaining tube inserted into a transpedicle channel formed from the pedicle of the vertebra to the vertebral body, and then bending it inside the vertebral body to reach the point where the flexible drilling tip is to be drilled (Figures 30-32, etc.). With this, it is possible to accurately drill the intended location all the way to the corner of the vertebral body, and since the path from the skin to the pedicle is straight, it is expected that skin incision can be kept to a minimum.

[0015] However, the inventors have noticed that when a device is introduced into the vertebral body along a straight retaining tube and deforms within the vertebral body, it is necessary to return the retaining tube to a straight cylindrical shape when removing it. However, depending on the condition of the bone inside, there is a risk that the deformation may not return to its original state, making removal difficult. In other words, a treatment device that is plastic and deforms within the vertebral body and is inserted into the vertebral bone may get caught on bone fragments, etc., and there is a risk that the plasticity will not return within the vertebral bone. In that case, if it does not return to a straight retaining tube and an attempt is made to forcibly remove it, there is a risk that the treatment device will break inside the body and a foreign object will be left inside the body. Therefore, even if the plastic treatment device disclosed in Patent Document 2 can solve the first and second problems described above, it cannot be said to be a safe treatment device.

[0016] Furthermore, the term "safety" in this application is not limited to the fact that the device does not become difficult to remove. The known treatment device described in Patent Document 1 above utilizes three-dimensional images to ensure safety. Conversely, it should be understood that without the use of such three-dimensional images, there is an inherent risk of perforating unintended areas, and safety is not guaranteed by the treatment device itself.

[0017] As described above, while there are means to solve each of the first three problems individually, a treatment device that can solve all of them simultaneously has yet to be developed.

[0018] The objective of the present invention is to provide a safe treatment device that allows for precise excavation of the intended area within the vertebral body while minimizing skin incisions during percutaneous vertebroplasty for fractures or prophylactic reinforcement of the vertebral body with bone cement.

[0019] The means for solving these problems are described below, but other problems and novel features will become clear from the description and accompanying drawings in this specification.

[0020] According to one embodiment of the present invention, the following applies:

[0021] That is, one embodiment of the present invention is a therapeutic device including a vertebral body perforation guide and a vertebral body processing instrument, which is configured as follows.

[0022] The vertebral body perforation guide is a hollow cylindrical shape along a central axis, and has a tip spatula portion, an intermediate portion, and a terminal portion in order from the proximal side along the central axis. The tip spatula portion opens in a direction perpendicular to the central axis, and the terminal portion has an opening in a direction perpendicular to the central axis. The opening in the terminal portion may be open to the entire terminal portion or only to a part of it. The inner diameter of the intermediate portion in the vertical direction is larger than the inner diameter of the tip spatula portion.

[0023] The vertebral body processing instrument is rod-shaped and has a curved portion that bends in the vertical direction along its central axis. It is inserted into the vertebral body drilling guide from its end portion along the central axis, and when it passes through the middle portion along the central axis, its tip protrudes from the opening of the tip spatula portion.

[0024] The effects obtained by the above embodiment can be briefly described below.

[0025] In other words, in percutaneous vertebroplasty for fractures and in surgeries to prophylactically reinforce vertebral bodies with bone cement, this device provides a safe treatment tool that allows for precise excavation of the intended area, even in the corners of the vertebral body, while minimizing skin incisions.

[0026] Figure 1 is a six-view diagram (rear view omitted) showing one example of the configuration of the vertebral body perforation guide that constitutes the therapeutic device of the present invention. Figure 2 is a six-view diagram (rear view omitted) showing another example of the configuration of the vertebral body perforation guide that constitutes the therapeutic device of the present invention. Figure 3 is a cross-sectional view of the vertebral body perforation guide shown in Figures 1 and 2. Figure 4 is an explanatory diagram showing one example of the configuration of the therapeutic device of the present invention from an oblique angle. Figure 5 is an explanatory diagram showing the perforation site of the vertebral body by the therapeutic device of the present invention. Figure 6 is an explanatory diagram showing the vertebral body perforation guide 1 equipped with a support part and a gripping part. Figure 7 is an explanatory diagram showing the area through which the vertebral body processing instrument passes when inserted into the vertebral body using the vertebral body perforation guide. Figure 8 is an explanatory diagram showing the main steps (first half) of the procedure for using the therapeutic device of the present invention. Figure 9 is an explanatory diagram showing the main steps (second half) of the procedure for using the therapeutic device of the present invention. Figure 10 is an explanatory diagram of the balloon catheter delivery tube. Figure 11 is a six-view diagram (rear view omitted) showing another example of the configuration of the vertebral body perforation guide that constitutes the therapeutic device of the present invention. Figure 12 is an explanatory diagram showing a perspective view of an example configuration of a treatment device including the vertebral body drilling guide shown in Figure 11, as another embodiment of the treatment device of the present invention. Figure 13 is a side view showing an example configuration of the bone cement filling device of the present invention and a pusher used therewith. Figure 14 is a cross-sectional view showing an example configuration of the bone cement filling device of the present invention and a pusher used therewith. Figure 15 is a cross-sectional view showing an example configuration of the bone cement filling device of the present invention and a syringe used therewith. Figure 16 is a cross-sectional view showing another example configuration of the bone cement filling device of the present invention and a pusher used therewith. Figure 17 is an explanatory diagram showing an example configuration of the bone cement filling device of the present invention and a slap hammer used therewith. Figure 18 is an explanatory diagram showing one example configuration of the vertebral body drilling guide and inner pipe of the present invention. Figure 19 is an explanatory diagram showing another example configuration of the vertebral body drilling guide and inner pipe of the present invention. Figure 20 is an explanatory diagram showing yet another example configuration of the vertebral body drilling guide and inner pipe of the present invention. Figure 21 is an explanatory diagram showing the main steps (first half) of the procedure for using the vertebral body perforation guide and inner pipe of the present invention. Figure 22 is an explanatory diagram showing the main steps (second half) of the procedure for using the vertebral body perforation guide and inner pipe of the present invention.

[0027] 1. Outline of Embodiments First, an outline of the representative embodiments disclosed in this application will be given. The reference numerals in parentheses in the drawings that are referenced in the outline of the representative embodiments are merely illustrative examples of components included in the concept of the components to which they are attached.

[0028] [1] Vertebral drilling guide and vertebral body processing instrument guided into the vertebral body thereby (Figures 1-4, 11-12) A typical embodiment disclosed in this application is a treatment device (100) including a vertebral drilling guide (1) and a vertebral body processing instrument (for example, a bone drilling instrument 2, a bone cement filling instrument 3, etc.), and is configured as follows.

[0029] The vertebral body perforation guide is a hollow cylindrical shape along a central axis, and along the central axis, from the proximal side, has a tip spatula portion (12), an intermediate portion (13), and a terminal portion (14) in that order. The tip spatula portion has an opening (11-1) perpendicular to the central axis, and the terminal portion has an opening (11-3) perpendicular to the central axis. The opening of the terminal portion is preferably formed on the proximal side, but it may be open to the entire terminal portion or only a part of it. The inner diameter of the intermediate portion in the perpendicular direction is larger than the inner diameter of the tip spatula portion.

[0030] The vertebral body processing instrument is rod-shaped and has a curved portion that curves in the vertical direction along the central axis. It is inserted into the vertebral body drilling guide from the end portion along the central axis, and when it passes through the middle portion along the central axis, the tip (21, 31) protrudes from the opening of the tip spatula portion.

[0031] Note that the direction of curvature here refers to the direction the end is pointing, while the direction in which the curved part protrudes is the opposite direction.

[0032] The curvature of the vertebral body processing instrument only needs to be curved enough to pass through the hollow portion of the vertebral body drilling guide. For example, it may be a structure that is curved throughout, a structure that includes straight sections, or a structure that is mostly straight with a localized, sharp bend. However, the curved section should be smoothly curved without abrupt changes in curvature, thereby reducing the risk of it getting caught on the vertebral body drilling guide during insertion / removal.

[0033] This makes it possible to provide a safe treatment instrument that allows for precise excavation of the intended area within the vertebral body while minimizing skin incisions during percutaneous vertebroplasty for fractures or prophylactic reinforcement of the vertebral body with bone cement. In particular, by making the inner diameter of the intermediate portion (13) (at least in the aforementioned vertical direction) larger than the outer diameter of the tip spatula portion (12), and consequently making the inner diameter of the terminal portion (14) the same as the inner diameter of the intermediate portion (13) and larger than the outer diameter of the tip spatula portion (12), the following further effects can be enjoyed.

[0034] The strength of the connection between the tip spatula section (12) and the intermediate section (13) can be increased.

[0035] In the process of inserting a curved vertebral body processing instrument into the hollow portion of the distal end (14) and passing it through the intermediate portion (13), the distal end (14), which is the root end, is thicker, making it less likely for the inserted vertebral body processing instrument (for example, bone drilling instrument 2, bone cement filling instrument 3, etc.) to get caught on surrounding muscles or fascia, thus making insertion easier.

[0036] The depth of insertion of the vertebral body drilling guide into the vertebral body can be easily adjusted. With the tip of the vertebral body drilling guide (tip spatula portion 12) inserted into the pedicle, the distal end can be strongly pushed in, such as by tapping it with a hammer. This widens the bone foramen of the pedicle at the connection point between the tip spatula portion (12) and the middle portion (13), allowing the vertebral body drilling guide to be easily inserted deeper.

[0037] Furthermore, the cross-sectional shape of the tip spatula portion (12), the middle portion (13), and the terminal portion (14) perpendicular to the central axis does not necessarily have to be circular. The size of the inner and outer diameters of each is sufficient as long as it satisfies the above-mentioned relationship in the direction perpendicular to the central axis and the opposite direction (for convenience, referred to as the up and down direction), that is, in the curvature direction of the vertebral body processing instrument. In the direction perpendicular to both the central axis of the vertebral body drilling guide and the curvature direction of the vertebral body processing instrument (for convenience, referred to as the left and right direction), the inner diameters of the tip spatula portion (12), the middle portion (13), and the terminal portion (14) should be larger than the outer diameter of the vertebral body processing instrument, and should be able to pass through it; they may even be the same size. In other words, if the inner diameters of the tip spatula portion (12), the middle portion (13), and the terminal portion (14) in the left-right direction are kept to the minimum necessary for the vertebral body processing tool to pass through, the cross-sectional shape perpendicular to the central axis of the tip spatula portion (12), the middle portion (13), and the terminal portion (14) can be an elongated oval, an ellipse, or a rectangle with rounded corners that is long in the vertical direction.

[0038] [2] Opening in the middle section (Figures 1-4) In the treatment device of [1], the middle section of the vertebral body perforation guide opens in the opposite direction to the vertical direction (11-2).

[0039] This allows even highly curved vertebral body processing instruments to pass through easily. On the other hand, the intermediate portion (13) of the vertebral body perforation guide in the treatment instrument [1] can be designed to not have an opening (Figures 11 and 12), in which case the overall strength of the vertebral body perforation guide is increased, and the risk of the vertebral body processing instrument getting caught on the surrounding muscles and fascial tissue when passing through the intermediate portion (13) is reduced.

[0040] [3] Support portion at the distal end (Figures 5-6) In the treatment instrument of [1], the vertebral body perforation guide is provided with a support portion (15) at its distal end that extends in the vertical direction and allows the vertebral body processing instrument to pass through.

[0041] This suppresses lateral movement of the vertebral body processing instrument (in directions perpendicular to both the vertical direction and the direction along the central axis) and allows for stable support.

[0042] 〔4〕Cylindrical vertebral perforation guide (Figs. 1-4) In [1], the cross-sectional shape perpendicular to the hollow central axis of the vertebral perforation guide is circular.

[0043] Thus, the manufacturing process can be simplified. A pipe with a variable thickness can be cut to a predetermined length and the opening of the spatula part can be cut for manufacturing, without the need for complex shaping cutting or welding.

[0044] 〔5〕Set of instruments required for percutaneous vertebroplasty (Figs. 4-9) The treatment instrument according to any one of [1] to [4] further includes an inner cannula needle (4) and a balloon catheter (5). When the inner cannula needle and the balloon catheter are inserted along the hollow central axis, their respective tips can protrude from the tip of the spatula part to the tip. The vertebral body processing instrument includes a bone perforation instrument (2) and a bone cement filling instrument (3). The vertebral body processing instrument may be a plurality of bone perforation instruments (2) and / or bone cement filling instruments (3) with different bending magnitudes.

[0045] Thus, the tip of the bone perforation instrument and / or the bone cement filling instrument can be guided to any location within the vertebral body, enabling cutting of the vertebral body bone and / or filling of the bone cement.

[0046] 〔6〕Set of treatment instrument including a balloon catheter delivery tube (Fig. 10) In the treatment instrument of [5], the vertebral body processing instrument further includes a balloon catheter delivery tube (53). When the balloon catheter is inserted into the balloon catheter delivery tube, its tip can protrude from the spatula part to the tip. The vertebral body processing instrument may be a straight or curved single or a plurality of balloon catheter delivery tubes (53) with different bending magnitudes.

[0047] Thus, the balloon catheter can be further introduced to any location within the vertebral body and the balloon can be expanded at any such location.

[0048] 〔7〕In the treatment instrument of 〔5〕or〔6〕having an inner cannula needle (Figs. 4, 12) with a through-hole for passing a guide pin, the inner cannula needle is hollow along the central axis and has a through-hole (49) through which the guide pin can pass along the central axis.

[0049] Thus, flexibility can be imparted to the beginning part of the surgical procedure in percutaneous vertebroplasty.

[0050] 〔8〕Combination with a curved bone cement filling instrument (Figs. 4, 13 to 17) A typical embodiment disclosed in the present application is a treatment instrument (100) including a vertebral perforation guide (1) and a bone cement filling instrument (3), which is configured as follows.

[0051] The vertebral perforation guide is a hollow cylindrical shape along a first central axis and has a tip spatula portion (12), an intermediate portion (13), and a distal end portion (14) in order from the proximal side along the first central axis.

[0052] The tip spatula portion and the distal end portion each open (11-1, 11-3) in a first direction perpendicular to the first central axis, and the intermediate portion has an opening (11-2) in a second direction opposite to the first direction.

[0053] The bone cement filling instrument has a shaft (34) having a second central axis and a bent portion (33) that bends in a direction away from the tip from the second central axis in order from the distal side to the proximal side. The shaft has a bone cement injection port (39) on the distal side, the bent portion has a bone cement ejection port (31) on the proximal side, and the shaft and the bent portion have hollow portions (35, 36) that communicate from the injection port to the ejection port.

[0054] The bone cement filling instrument is inserted into the vertebral perforation guide along the first central axis from the distal end portion, and when passing through the intermediate portion along the first central axis, the ejection port projects from the opening of the tip spatula portion.

[0055] This allows for the precise injection of bone cement into every corner of the vertebral body while minimizing skin incisions. In particular, it enhances safety by making it easier to remove the bone cement filling device even if it becomes embedded and fixed in the injected bone cement.

[0056] [9] Opening on the proximal side of the distal end of the vertebral body perforation guide In the treatment device of [8], the opening at the distal end of the vertebral body perforation guide is formed to be localized to the proximal side.

[0057] This prevents the formation of an opening at the distal end of the vertebral body perforation guide, thereby increasing the mechanical strength of the handle portion of the vertebral body perforation guide.

[0058]

[10] Curved bone cement filling instrument with slap hammer connection part (Figure 17) In the treatment instrument of [8] or [9], the shaft of the bone cement filling instrument (3) is provided with a connection part (37) distal to which a slap hammer (70) can be connected.

[0059] This allows the bone cement filling device to be subjected to an impact that can detach it from the bone cement even if the tip of the bone cement filling device becomes embedded in the bone cement filling the vertebral body and the bone cement hardens, making it easier to remove the bone cement filling device.

[0060]

[11] Curved bone cement filling device + syringe (Figure 15) In the treatment device of [8] or [9], the bone cement filling device further comprises a bone cement injector (61), the shaft comprises a bone cement filling portion (60) on the distal side, the bone cement injector is inserted into the hollow portion of the bone cement filling portion and pushes the bone cement filled in the hollow portion from the injection port into the hollow portion (35, 36) of the curved portion. At this time, the bone cement may be pre-filled not only in the bone cement filling portion, but also in the hollow portion (35) of the shaft (34) and the hollow portion (36) of the curved portion. In this case, the distal diameter of the shaft (34) may be increased to form a bone cement filling section (60), and the pushing rod (45; see Figure 13) inserted therein may be configured to function as a bone cement pushing section (61). Alternatively, a syringe equipped with a syringe and a plunger may be connected to the injection port (39; see Figure 13) of the shaft (34), with the syringe functioning as the bone cement filling section (60) and the plunger functioning as the bone cement pushing section (61).

[0061] This allows for the filling of a large volume of bone cement. The proximal side of the shaft connected to the curved section may be a conduit with a small inner diameter of the hollow section, or the entire hollow section of the shaft may be used as the bone cement filling section.

[0062]

[12] Screw-structured bone cement indentation section (Figure 16) In the treatment device of

[11] , the outer circumference of the bone cement indentation section and the inner wall of the hollow section of the shaft constituting the bone cement filling section have screw threads that screw into each other. The location of the screw threads in the bone cement filling section (60) is not shown in the figure, but may be limited to the distal or intermediate part of the bone cement filling section.

[0063] This allows the bone cement to be pushed in under pressure and smoothly ejected from the injection port.

[0064]

[13] Curved bone cement filling device (with slap hammer connector) + syringe (Figures 15, 16) In the treatment device of

[11] , the bone cement filling device is further provided with a connector (37) on the distal side of the shaft to which a slap hammer (70) can be connected.

[0065] This allows the bone cement filling device to be subjected to an impact that promotes release from the bone cement even if the tip of the bone cement filling device becomes embedded in the bone cement filling device and the bone cement hardens, making it easier to remove the bone cement filling device.

[0066]

[14] Vertebral perforation guide and inner pipe (Figures 18, 19, 20) A typical embodiment disclosed in this application is a therapeutic device including a vertebral perforation guide (1) and an inner pipe (8) for guiding a vertebral processing instrument having a curved portion that curves in a direction perpendicular to a first central axis into the vertebral body, and is configured as follows.

[0067] The vertebral body perforation guide is a hollow cylindrical shape along a second central axis, and along the second central axis, it has a tip spatula portion (12), an intermediate portion (13), and a terminal portion (14) in order from the proximal side. The tip spatula portion and the terminal portion have openings (11-1, 11-3) in a first direction perpendicular to the second central axis, the intermediate portion has an opening (11-2) in the opposite direction to the first direction, and the inner diameter of the intermediate portion is larger than the inner diameter of the tip spatula portion.

[0068] The inner pipe is cylindrical along the third central axis and has a side wall (81) that closes the opening in the intermediate portion when inserted along the second central axis at the end and intermediate portions.

[0069] This provides a safer treatment device that eliminates the concern that the vertebral body processing instrument might get caught in the opening in the middle of the vertebral body and injure the surrounding muscles when guiding the instrument into the vertebral body using a vertebral body drilling guide with an opening in the middle.

[0070]

[15] The distal end of the vertebral body perforation guide is open on the proximal side (Figure 18). In the treatment instrument of

[14] , the inner pipe is cylindrical along the third central axis and has a hollow portion (82) that communicates with the hollow of the tip spatula portion when inserted along the second central axis at the distal and intermediate portions. This allows the hollow portion of the inner pipe to communicate smoothly with the tip spatula portion of the vertebral body perforation guide, enabling the linear instrument to be guided smoothly.

[0071]

[16] The distal end of the vertebral body perforation guide opens proximally (Figure 18) In the treatment device of

[14] or

[15] , the opening of the distal end of the vertebral body perforation guide is formed to be localized to the proximal side.

[0072] This prevents the formation of an opening at the distal end of the vertebral body perforation guide, thereby increasing the mechanical strength of the handle portion of the vertebral body perforation guide.

[0073]

[17] Connection of vertebral body perforation guide and inner pipe (Figures 18-20) In any one of the treatment devices described in

[14] to

[17] , the vertebral body perforation guide and the inner pipe each have connecting parts (17, 87) that can be connected to each other.

[0074] This allows the vertebral body perforation guide and the inner pipe to be integrated into a single unit.

[0075] 2. Details of the Embodiments The embodiments will be described in more detail below.

[0076] [Embodiment 1] A typical embodiment disclosed in this application is a treatment device 100 including a vertebral body drilling guide 1 and a vertebral body processing instrument, and is configured as follows. The vertebral body processing instrument may be, for example, a bone drilling instrument 2 or a bone cement filling instrument 3, as will be described later with reference to Figure 4, etc., but is not limited to these.

[0077] Figures 1 and 2 are six-view diagrams (the posterior view is omitted) showing an example configuration of the vertebral body perforation guide 1, and Figure 3 is a cross-sectional view. Figure 4 is an explanatory diagram showing an example configuration of the treatment device 100 of the present invention in a perspective view.

[0078] The vertebral body perforation guide 1 is a hollow cylindrical shape aligned with the central axis (x-axis in Figure 4), and has a tip spatula portion 12, an intermediate portion 13, and a terminal portion 14 in order from the proximal side along the central axis. The inner diameter of the intermediate portion 13 is designed to be larger than the inner diameter of the tip spatula portion 12. Although not particularly limited, the terminal portion 14 can also have the same diameter as the intermediate portion 13. The tip spatula portion 12 and the terminal portion 14 have openings 11-1 and 11-3 in a direction perpendicular to the central axis (the -z direction in Figure 4), respectively. The intermediate portion 13 has an opening 11-2 in the opposite direction (the +z direction).

[0079] A more detailed view of the openings is illustrated in Figure 3. The opening 11-1 of the tip spatula section 12 is a semicircular shape with an outer diameter of φp that opens downward (in the -z direction). The opening 11-2 of the intermediate section 13 is an arc shape with an inner diameter of φd that opens upward (in the +z direction) with an opening width Wb. The opening 11-3 of the end section 14 is an arc shape with an inner diameter of φd that opens downward (in the -z direction) with an opening width Wc. The connection between the tip spatula section 12 and the intermediate section 13 is processed to smoothly change its diameter (see the front view in Figure 1), and the openings 11-1 and 11-2 also close smoothly toward the connection (see the bottom and top views in Figure 1). The connection between the intermediate section 13 and the terminal section 14 does not change in diameter (see the front view in Figure 1), but the openings 11-2 and 11-3 have a shape that smoothly closes toward the connection (see the bottom and top views in Figure 1).

[0080] The terminal portion 14, like the tip spatula portion 12, does not need to have a continuous opening all the way to the root side, and may have a structure in which the opening 11-3 is installed only in the area through which the vertebral body processing instrument passes. Figure 2 is a six-view drawing (rear view omitted) showing another example of the configuration of the vertebral body drilling guide 1. The configuration of the tip spatula portion 12 and the intermediate portion 13 is the same as that of the vertebral body drilling guide 1 shown in Figure 1, but the terminal portion 14 has an opening 11-3 that opens from the connection part with the intermediate portion 13 to a position of length Lc, and the distal end is cylindrical with no opening. When attaching a support portion 15, etc., which will be described later, to the distal end, the mounting strength can be strengthened.

[0081] The vertebral body processing instrument is, for example, a bone drilling instrument 2 or a bone cement filling instrument 3, as shown in Figure 4. It is rod-shaped and has a curved portion that curves along the central axis in the vertical direction (the -z direction in Figure 4). It is inserted into the vertebral body drilling guide 1 from the distal end 14 along the central axis, and when it passes through the middle section 13 along the central axis, the tip 21 or 31 protrudes from the opening 11-1 of the tip spatula section 12. The curvature of the vertebral body processing instrument is downward (-z direction) at the middle section 13 and in the opposite upward direction (+z direction) at the distal end 14. Curvature is sufficient if it is at least downward (-z direction) at the middle section 13, but it is more preferable to curve it in the opposite upward direction (+z direction) at the distal end 14 to form an S-shape overall. By curving the vertebral body into an S-shape, forces in the direction along the central axis (x-axis direction) are more easily transmitted, improving the operability of insertion and removal operations and instruments for bone drilling. Here, the direction of curvature refers to the direction in which the ends face, while the direction in which the curved portion protrudes is the opposite direction. The direction of the curved structure is not strictly defined, and it is preferable to prepare vertebral body processing instruments with a degree of curvature that is easy to use and does not interfere with other instruments, depending on the situation in the surgical field.

[0082] The inner diameter of the tip spatula portion 12 should be larger than the outer diameter of the vertebral body processing instrument, the inner diameter Φd of the intermediate portion 13 should be larger than the inner diameter Φp of the tip spatula portion 12, and the inner diameter of the terminal portion 14 should be the same as the inner diameter Φd of the intermediate portion 13. The opening width Wb of the opening 11-2 of the intermediate portion 13 and the opening width Wc of the opening 11-3 of the terminal portion 14 should also be larger than the outer diameter of the vertebral body processing instrument.

[0083] Assuming the outer diameter of the vertebral body processing instrument, such as the bone drilling instrument 2 or the bone cement filling instrument 3, is 4 mm, the vertebral body drilling guide 1 has an inner diameter of 5 mm at the tip spatula portion 12, and an inner diameter of 7 mm at the middle portion 13 and the terminal portion 14, forming openings 11-1, 11-2, and 11-3 with a width of 4.5 mm, respectively.

[0084] The treatment instrument 100 of the present invention can be configured to guide the tip of the vertebral body processing instrument to an appropriate position within the vertebral body by appropriately designing the positions of the tip spatula portion 12, the intermediate portion 13, and the terminal portion 14 of the vertebral body perforation guide 1, particularly the positions of the openings 11-1, 11-2, and 11-3, and the curvature of the vertebral body processing instrument.

[0085] Figure 5 is an explanatory diagram showing the possible locations for vertebral body perforation using the treatment instrument 100. It schematically represents the vertebral body, which is the affected area, viewed fluoroscopy from the left side of the patient while the patient is standing, with the left being the ventral side, the right the dorsal side, the top being the cranial side, and the bottom being the caudal side. Applying the coordinate system shown in Figure 4, the left is the +x direction, the right is the -x direction, the top is the +z direction, and the bottom is the -z direction. It shows the state in which the skin 99 is incised from the dorsal side and the vertebral body perforation guide 1 is inserted into the vertebral body 90 through the pedicle 91. The bone drilling instrument 2 is used as an example of a vertebral body processing instrument for explanation, but the same applies to other instruments. The cases where the curvature of the bone drilling instrument 2 is large (small radius of curvature) [A] and the case where the curvature is small (large radius of curvature) [B] are shown, and for comparison, the case where a straight, uncurved inner tube needle 4 is inserted [C] is also shown.

[0086] As shown in [C], when a straight inner needle 4 that is not curved is inserted into the vertebral body perforation guide 1, it reaches the ventral side of the vertebral body 90. On the other hand, when a bone drilling instrument 2 is inserted into the vertebral body perforation guide 1, the position within the vertebral body 90 that its tip reaches is determined by the degree of curvature of the bone drilling instrument 2 and the position of the connection between the tip spatula portion 12 and the intermediate portion 13 and the connection between the intermediate portion 13 and the distal portion 14. More specifically, the position of the bone drilling instrument 2 is determined by contact with the distal end of the second opening 11-2 or the proximal end of the third opening 11-3 at the connection between the intermediate portion 13 and the distal portion 14, and with the proximal end of the second opening 11-2 or the distal end of the first opening 11-1 at the connection between the tip spatula portion 12 and the intermediate portion 13. As shown in [A], when the curvature of the bone drilling instrument 2 is large (small radius of curvature), the curvature of the bone drilling instrument 2 protrudes significantly upward (+z direction) from the second opening 11-2 of the intermediate part 13, and the tip of the bone drilling instrument 2 can reach relatively close to the front (dorsal side of the patient) inside the vertebral body 90. As shown in [B], when the curvature of the bone drilling instrument 2 is small (large radius of curvature), the curvature of the bone drilling instrument 2 protrudes less from the second opening 11-2 of the intermediate part 13, and the tip of the bone drilling instrument 2 can reach relatively deep inside (ventral side of the patient) inside the vertebral body 90.

[0087] The reachable position of the tip of a vertebral body processing instrument (e.g., bone drilling instrument 2) within the vertebral body is determined by the curvature and the position of the opening of the vertebral body drilling guide 1, as described above. Furthermore, it can be adjusted by adjusting the depth to which the vertebral body drilling guide 1 is inserted into the pedicle. For example, when the vertebral body processing instrument is a bone drilling instrument 2, the range of bone drilling within the vertebral body can be adjusted by the curvature of the bone drilling instrument 2 and the insertion depth of the vertebral body drilling guide 1. In addition, by preparing and using multiple bone drilling instruments 2 with different curvatures, it is possible to accurately drill into the intended location, even in the corners of the vertebral body.

[0088] As shown in Figure 5, the greater the curvature of the bone drilling instrument 2 in the middle section 13 of the vertebral body drilling guide 1, the further it will move away from the vertebral body drilling guide 1 at the distal end. Therefore, as described above, by curving the bone drilling instrument 2 upward (+z direction) at the position where it passes the distal section 14, and curving it into an S-shape as needed, the distance between the vertebral body drilling guide 1 and the bone drilling instrument 2 at the distal end can be kept small.

[0089] In the treatment device 100, it is preferable that the vertebral body perforation guide 1 has a support portion 15 at its distal end that extends downward and allows a vertebral body processing instrument (bone drilling instrument 2 in the example of Figure 5) to pass through. This suppresses lateral movement of the vertebral body processing instrument (y-axis direction in Figure 4) and allows the vertebral body processing instrument to be stably supported. As shown in Figure 4, the support portion 15 is preferably extended in the -z direction and has an inverted U-shape at its lower end to allow the vertebral body processing instrument to pass through. If it is open in an inverted U-shape, even if the curvature of the vertebral body processing instrument is large, it is still possible to insert the vertebral body processing instrument into the vertebral body perforation guide 1 even if it cannot be supported at a large distance from the vertebral body perforation guide 1 at the distal end. On the other hand, although not shown in the illustration, the support portion 15 may also be closed in an oval shape. In this case, if the curvature of the vertebral body processing instrument is large and the distal end is far from the vertebral body perforation guide 1, it is necessary to extend the support portion 15 to that position, but the structure is robust. The shape of the support portion 15 must be designed considering not only the state in which the vertebral body processing instrument is inserted, but also the trajectory during the insertion process.

[0090] The vertebral body drilling guide 1 preferably includes a gripping portion 16. Figure 6 is an explanatory diagram showing a vertebral body drilling guide 1 equipped with a support portion and a gripping portion. An oblique view is shown on the upper side, and an example of a curved bone drilling instrument 2 inserted as an example of a vertebral body processing instrument is shown on the lower side. The support portion 15 is attached to the distal end of the vertebral body drilling guide 1, similar to the example shown in Figure 5, and extends in the -z direction with its lower end open in an inverted U shape. The gripping portion 16 is also attached to the distal end of the vertebral body drilling guide 1 and extends in the +z direction. This improves workability, such as when the surgeon grasps and supports the gripping portion 16 while striking the head of the grip 22 at the distal end of the bone drilling instrument 2 with a hammer. The gripping portion 16 exemplified in Figure 6 has the same width, thickness, and length as the support portion 15, but any shape and size that is easy to grasp can be adopted. The mounting direction is not limited to the +z direction, but can be any direction, and may be mounted in multiple directions. Furthermore, the support portion 15 and the gripping portion 16 may be integrally formed from the same material, such as plastic. On the other hand, the gripping portion 16 does not necessarily need to be mounted together with the support portion 15, and a vertebral body perforation guide 1 without a support portion 15 may have a gripping portion 16.

[0091] Figure 7 is an explanatory diagram showing the path taken when inserting the vertebral body processing instrument into the vertebral body using the vertebral body drilling guide 1. Similar to Figure 5, it schematically represents the vertebral body, which is the affected area, viewed fluoroscopy from the left side of the patient while the patient is standing. The left side of the paper is the ventral side, the right side is the dorsal side, the top is the cranial side, and the bottom is the caudal side. The bone drilling instrument 2 is used as an example of the vertebral body processing instrument, but the same applies to other instruments. [A] shows the case where the curvature of the bone drilling instrument 2 is large (small radius of curvature), and [B] shows the case where the curvature is small (large radius of curvature). In both [A] and [B], the dashed line shows the state in which the vertebral body processing instrument (bone drilling instrument 2) has been inserted deep into the vertebral body to the bone drilling position.

[0092] When inserting the bone drilling instrument 2 into the vertebral body drilling guide 1, the tip of the bone drilling instrument 2 is advanced proximally along the distal end 14 of the vertebral body drilling guide 1, passing through the opening 11-3 of the distal end 14 to the connection point with the intermediate end 13, and then inserted further proximally. With the tip of the bone drilling instrument 2 still aligned with the intermediate end 13, the distal end is inserted further deeper, passing through the connection point between the distal end 14 and the intermediate end 13, and the tip of the bone drilling instrument 2 passes through the connection point between the intermediate end 13 and the tip spatula 12, protruding from the opening 11-1 of the tip spatula 12. As shown in Figure 7, when the curvature of the vertebral body processing instrument (bone drilling instrument 2) is large ([A]), the distance of the vertebral body processing instrument (bone drilling instrument 2) from the vertebral body drilling guide 1 at the distal end is larger than when the curvature is small ([B]). The support portion 15 may be extended as shown by the dashed line to the point where the gap becomes larger, or it may be stopped near the point shown by the solid line, and the distal side of the vertebral body processing instrument (bone drilling instrument 2) may be curved upward (+z direction) to form an S shape so that it is supported by the support portion 15. By providing the support portion 15 in this way, lateral movement when inserting the vertebral body processing instrument (bone drilling instrument 2) can be suppressed, and the operation can be stabilized.

[0093] As can be seen from Figure 7, by designing the connection between the distal part 14 and the intermediate part 13 to be located near the incision in the skin 99, the incision in the skin 99 can be minimized. When inserting the vertebral body processing instrument (bone drilling instrument 2) into the vertebral body drilling guide 1, the instrument passes away from the vertebral body processing instrument (bone drilling instrument 2) as it moves away from the connection between the distal part 14 and the intermediate part 13, but there is no separation between the vertebral body processing instrument (bone drilling instrument 2) and the vertebral body drilling guide 1 at that connection point.

[0094] As explained above, in percutaneous vertebroplasty for fractures and in surgery to prophylactically reinforce the vertebral body with bone cement, we can provide a safe treatment instrument 100 that can accurately excavate the intended area all the way to the corner of the vertebral body while minimizing skin incisions. In particular, by making the inner diameter of the intermediate section 13 larger than the inner diameter of the tip spatula section 12, and consequently making the inner diameter of the distal section 14 the same as the inner diameter of the intermediate section 13, the distal section 14 also becomes larger than the inner diameter of the tip spatula section 12, and the following effects can be enjoyed.

[0095] The structure of the connection between the tip spatula portion 12 and the intermediate portion 13 can be preserved, and the strength of the connection can be increased.

[0096] In the process of inserting the curved vertebral body processing instrument (bone drilling instrument 2) into the hollow portion of the distal end 14 and passing it through the intermediate portion 13, the distal end 14, which is the root end, is thicker, making it less likely for the inserted vertebral body processing instrument (bone drilling instrument 2) to get caught on surrounding muscles or fascia, thus making insertion easier.

[0097] The depth of insertion of the vertebral body drilling guide 1 into the vertebral body can be easily adjusted. With the tip (spatula tip 12) of the vertebral body drilling guide 1 inserted into the pedicle 91, the distal end can be strongly pushed in, such as by striking it with a hammer. This widens the bone hole of the pedicle 91 at the connection point between the spatula tip 12 and the intermediate part 13, allowing the vertebral body drilling guide 1 to be easily inserted deeper.

[0098] [Embodiment 2] The treatment instrument 100 of the present invention preferably comprises a vertebral body drilling guide 1, a bone drilling instrument 2 and a bone cement filling instrument 3 as vertebral body processing instruments, and further comprises an inner needle 4 and a balloon catheter 5, as illustrated in Figure 4. The inner needle 4 and balloon catheter 5 are linear and are inserted distally along the central axis of the vertebral body drilling guide 1, protruding from the tip of the tip spatula portion 12. This makes it possible to provide a set of instruments necessary for percutaneous vertebroplasty.

[0099] The bone drilling instrument 2 is rod-shaped and has a tip portion 21 with a sharp structure for drilling bone at its end. As explained with reference to Figures 5 and 7, it has a curved portion that curves downward (-z direction) along the central axis. It is inserted from the distal portion 14 along the central axis, and when it passes through the intermediate portion 13 along the central axis, the tip portion 21 protrudes from the opening 11-1 of the tip spatula portion 12. As described above, it may also be curved in an S shape. Furthermore, as illustrated in Figure 4, it may have a grip 22 at the distal end.

[0100] The bone cement filling device 3 is a hollow cylindrical shape along its central axis, with an injection port 31 at its tip and an injection port 39 at its distal end, and is curved downward along its central axis (-z direction), i.e., in the same direction as the bone drilling device 2. The bone cement pre-filled inside the bone cement filling device 3 may be pushed out from the injection port 31 with an extrusion rod, or it may be configured so that the bone cement is pushed in from the injection port 39 under pressure using a syringe or the like, and then injected from the injection port 31. The curvature of the bone cement filling device 3 is about the same as or less than that of the bone drilling device 2. That is, when it is inserted along the terminal part 14 to the intermediate part 13 of the vertebral body drilling guide 1, the injection port 31 protrudes from the opening 11-1. This allows the tip (injection port 31) of the bone cement filling device 3 to be guided precisely along the same trajectory as the cavity drilled by the bone drilling device 2, and the required amount of bone cement can be precisely filled into the drilled cavity.

[0101] The inner needle 4 is a straight cylinder or cylindrical shape along its central axis (x-axis), and can linearly penetrate the hollow portion of the vertebral body drilling guide 1. That is, it does not need to pass through the openings 11-1, 11-2, and 11-3 of the vertebral body drilling guide 1, but is introduced into the interior of the vertebral body simply by passing along its central axis. The tip of the inner needle 4 is provided with a bone drilling portion 41 with a sharp structure, and its outer circumference may have screw threads (not shown) to assist in tapping. It is preferable that the distal end of the inner needle 4 is provided with a grip 42. The grip 42 may further have a connection portion (not shown) with the vertebral body drilling guide 1, and when connected, the inner needle 4 and the vertebral body drilling guide 1 may be configured to become one. This integration improves operability in tasks such as processing bone holes in the pedicle. Furthermore, the central axis of the inner needle 4 may be provided with a through hole 49 through which a guide pin 9 can pass.

[0102] The balloon catheter 5 is linear and is inserted distally along the central axis of the vertebral body perforation guide 1, protruding from the tip of the spatula-shaped tip 12. The balloon catheter 5 has a plastic shaft and can be directly inserted into the vertebral body perforation guide 1, or, as will be described in later embodiment 3, it can be introduced into the vertebral body through a curved balloon catheter delivery tube 53.

[0103] [Procedure] Figures 8 and 9 are explanatory diagrams showing the main steps in the procedure for using the therapeutic device 100 of the present invention. Similar to Figures 5 and 7, they schematically represent the vertebral body, which is the affected area, viewed fluoroscopy from the left side of the patient while the patient is standing, with the left being the ventral side, the right being the dorsal side, the top being the cranial side, and the bottom being the caudal side.

[0104] Prior to step [1], the skin 99 is incised in advance (creating an opening 98) to form a bone hole that penetrates the pedicle 91 and leads to the vertebral body 90. In step [1], the inner needle 4 is inserted into the vertebral body drilling guide 1, and while viewing the intraoperative fluoroscopic X-ray image, the vertebral body drilling guide 1 and the inner needle 4 are inserted into the bone hole that has been pre-formed in the pedicle 91, and the tip is introduced into the vertebral body 90. Alternatively, without pre-forming a bone hole, the inner needle 4 and the vertebral body drilling guide 1 may be used as an integrated unit, and bone drilling may be performed while viewing the intraoperative fluoroscopic image, penetrating the pedicle 91 and introducing the needle into the vertebral body 90. Alternatively, a different hollow, linear perforating instrument may be inserted through the pedicle 91 into the vertebral body 90, and a guide pin 9 may be placed in the bone hole of the pedicle 91 using the linear perforating instrument. Then, using the placed guide pin 9 as a guide, the vertebral body perforation guide 1 and inner needle 4 may be inserted and their tips introduced into the vertebral body 90. Alternatively, the guide pin 9 may be inserted directly first, and the integrated vertebral body perforation guide 1 and inner needle 4 may be introduced along it. Alternatively, the inner needle 4 may be introduced directly into the vertebral body 90 first, and the vertebral body perforation guide 1 may be introduced into the vertebral body 90 using the inner needle 4 as a guide. These are established as safe surgical techniques.

[0105] Step [2]: Figure 8 [2] shows the vertebral body perforation guide 1 and inner needle 4 inserted into the vertebral body through a bone hole formed in the pedicle 91 by one of the above procedures. As shown in the figure, it is desirable that the connection between the tip spatula portion 12 and the middle portion 13 of the vertebral body perforation guide 1 is located near the boundary between the pedicle 91 and the vertebral body 90, and the connection between the middle portion 13 and the terminal portion 14 is located near the opening 98. The inner needle 4 is then removed from this position.

[0106] Step [3]: Insert the balloon catheter 5 through the vertebral body perforation guide 1. In Figure 8, the balloon catheter 5 is simplified, and the balloon inflator 52 attached to the distal end is omitted from the illustration. Inflate the balloon 51 inside the vertebral body 90 to form a cavity inside the vertebral body 90. If the vertebral body 90 is deformed due to a compression fracture, the pressure of the balloon 51 can also restore it to its original size.

[0107] Step [4]: ​​Insert the bone drilling instrument 2-1 with a small curvature into the vertebral body 90 through the vertebral body drilling guide 1 and drill. Because it is curved, it is possible to drill into the bone and expand the cavity to the anterior inferior corner of the vertebral body 90, where the balloon 51 could not form a cavity.

[0108] Step [5] (see Figure 9 thereafter): Insert the highly curved bone drilling instrument 2-2 into the vertebral body 90 through the vertebral body drilling guide 1 and drill. Because of the large curvature, the balloon 51 cannot form a cavity, and the bone drilling instrument 2-1, which could not reach, can be used to drill into the lower endplate 92b of the vertebral body 90 and a position closer to the dorsal side.

[0109] Step [6]: Insert the non-curved bone cement filling instrument 3-0 into the vertebral body 90 through the vertebral body perforation guide 1 and fill the formed cavity with bone cement 97.

[0110] Step [7]: Insert the bone cement filling instrument 3-1 with a small curvature into the vertebral body 90 through the vertebral body drilling guide 1 and fill the bone-drilled area on the lower anterior side of the cavity with bone cement 97.

[0111] Step [8]: Insert the highly curved bone cement filling instrument 3-2 into the vertebral body 90 through the vertebral body drilling guide 1 and fill the bone-drilled area in the lower center of the cavity with bone cement 97.

[0112] The order of steps [6], [7], and [8] may be changed depending on the condition of the vertebral body, etc. For example, the bone cement filling instrument 3-2 with a greater curvature in step [8] may be used first for filling, or the order may not be fixed, and cement filling instruments 3-0 to 3-2 with different degrees of curvature may be appropriately selected and used alternately depending on the degree of bone cement filling. This makes it possible to fill the bone cement in the intended location.

[0113] Subsequently, the vertebral body perforation guide 1 may be removed and the wound closed to complete the surgery. Alternatively, a step may be performed in which screws are screwed into the filled bone cement 97 from the pedicle 91 side, either through the vertebral body perforation guide 1 or using another instrument. In addition, this procedure may be used in combination with other procedures. Other procedures may include, for example, the implantation of a spinal cage or artificial intervertebral disc implant in the intervertebral space between the lower endplate 92b and the vertebral body further below. Other procedures may include, for example, vertebral fusion surgery in which similar procedures are performed on multiple vertebral bodies and then they are fixed with rods.

[0114] [Embodiment 3] Figure 10 is an explanatory diagram of the balloon catheter delivery tube 53. The balloon catheter 5 has a plastic shaft and can be directly inserted into the vertebral body perforation guide 1, or it can be introduced into the vertebral body through the curved balloon catheter delivery tube 53. In Figure 10, the pathway from the incision in the skin 99, through the pedicle 91, to the vertebral body 90 is depicted fluoroscopically from the left side of the patient, similar to Figures 7-9. [A] shows the case when the balloon catheter delivery tube 53 is not used, and [B], [C], and [D] show the cases where the curvature of the balloon catheter delivery tube 53 is small, large, and not curved, respectively. The balloon catheter delivery tube 53 passes inside the vertebral body perforation guide 1, and the balloon catheter 5 passes inside either the vertebral body perforation guide 1 or the balloon catheter delivery tube 53, so they are not actually visible from the side, but for the sake of understanding, both the balloon catheter 5 and the balloon catheter delivery tube 53 are drawn with solid lines except for a part of them.

[0115] The shaft of the balloon catheter 5 is plastic, but as shown in [A], when inserted directly into the vertebral perforation guide 1, it is inserted linearly along its central axis, and the tip protrudes from the tip spatula portion 12, so that the balloon 51 can be expanded relatively high up in the vertebral body 90. As shown in [B], if a balloon catheter delivery tube 53 with a relatively small curve is inserted into the vertebral perforation guide 1 and its tip is guided in advance to the area just before the center of the vertebral body 90, and then the balloon catheter 5 is inserted, the balloon catheter 5 will curve along the balloon catheter delivery tube 53, and its tip will be guided to the area just before the center of the vertebral body 90, so that the balloon 51 can be inflated near the center of the vertebral body 90. As shown in [C], if a balloon catheter delivery tube 53 with a relatively large curvature is inserted into the vertebral perforation guide 1 and its tip is guided in advance to the vicinity of the vertebral body 90, and then the balloon catheter 5 is inserted, the balloon catheter 5 will curve along the balloon catheter delivery tube 53 and its tip will be guided to the vicinity of the vertebral body 90, so that the balloon 51 can be inflated in the vicinity of the vertebral body 90. As shown in [D], instead of directly inserting the balloon catheter 5 linearly into the vertebral perforation guide 1, a straight balloon catheter delivery tube 53 that does not curve may be inserted into the vertebral perforation guide 1, and the balloon catheter 5 may be introduced into the vertebral body 90 through the balloon catheter delivery tube 53. This makes the introduction of the balloon catheter 5 into the vertebral body 90 smoother.

[0116] As described above, by preparing multiple balloon catheter delivery tubes 53 with varying degrees of curvature, the balloon 51 can be inflated at any number of locations intended by the surgeon, depending on the condition inside the vertebral body 90, thereby more appropriately forming a bone cement filling space (cavity).

[0117] In the procedure described above with reference to Figures 8 and 9 in Embodiment 2, an example is shown in which the balloon catheter 5 is inserted directly into the vertebral body perforation guide 1 without using the balloon catheter delivery tube 53 in step [3]. However, instead of this, or in addition to this, a plurality of balloon catheter delivery tubes 53 with various curvatures, as shown in Figures 10 [B] and [C], can be used to form a complete bone cement filling space (cavity) within the vertebral body 90.

[0118] [Embodiment 4] The vertebral body perforation guide 1 may have a form in which the intermediate portion 13 does not have an opening 11-2. As described in Embodiments 1 to 3, if an opening 11-2 is provided in the intermediate portion 13, when a curved vertebral body processing instrument (for example, a bone drilling instrument 2, a bone cement filling instrument 3, or a curved balloon catheter delivery tube 53) is passed through, the curved portion will protrude outward from the opening 11-2 of the intermediate portion 13 as it passes through. The outside of the intermediate portion 13 is usually soft, such as the muscles on the back of the patient, so there is no problem even if the vertebral body processing instrument protrudes as it passes through. However, if the passing vertebral body processing instrument has a protrusion, and if the muscles on the outside of the intermediate portion 13 are pushed into the opening 11-2 of the intermediate portion 13, it cannot be said that there is absolutely no risk that the passing vertebral body processing instrument will get caught on the muscles and even injure them. In contrast, the vertebral body perforation guide 1 of this embodiment 4 does not have an opening 11-2 in the intermediate portion 13.

[0119] Figure 11 is a six-view diagram (the posterior view is omitted) showing an example configuration of the vertebral body perforation guide 1 of Embodiment 4, and Figure 12 is an explanatory diagram showing an example configuration of the treatment device 100 including the vertebral body perforation guide 1 in a perspective view.

[0120] The vertebral body drilling guide 1 is a hollow cylindrical shape along the central axis (x-axis in Figure 4), similar to the vertebral body drilling guide 1 of Embodiment 1 shown in Figure 1. It has a tip spatula portion 12, an intermediate portion 13, and a terminal portion 14 in order from the proximal side along the central axis. It differs in that the intermediate portion 13 does not have an opening 11-2. The diameter of the intermediate portion 13 needs to be determined according to the curvature of the vertebral body processing instrument to be passed through. If the curvature is large, the diameter of the intermediate portion 13 also needs to be large. The diameter of the intermediate portion 13 only needs to be large in the vertical direction, so as illustrated in Figure 11, the intermediate portion 13 can be an oval or ellipse with a cross section perpendicular to the central axis that is long in the vertical direction. Here, mathematically strictly speaking, an oval means having a straight portion between two semicircles, but in this embodiment 4, this is not particularly strict and means a closed curve in which the diameter in the vertical direction is longer than the diameter in the horizontal direction. The other configurations are the same as the vertebral body drilling guide 1 of Embodiment 1 shown in Figure 1, so their explanation is omitted. For example, the cross-sectional shape of the end portion 14 may be a perfect circle, but it can also be the same shape as the intermediate portion 13.

[0121] The vertebral body processing instrument is similar to that in Embodiment 1, for example, as shown in Figure 5, a bone drilling instrument 2, a bone cement filling instrument 3, and a curved balloon catheter delivery tube 53, and is rod-shaped with a curved portion that curves along the central axis in the direction perpendicular to the central axis (the z-axis direction in Figure 5). Furthermore, the treatment instrument 100 is preferably composed of other instruments, such as a bone drilling inner tube, a balloon catheter 5, and a balloon catheter delivery tube 53, similar to Embodiments 1 to 3. Except for the absence of an opening 11-2 in the intermediate section 13, it is the same as Embodiments 1 to 3, so a detailed explanation is omitted.

[0122] [Embodiment 5] The treatment device of the present invention may be configured to include a curved bone cement filling device 3 in addition to the vertebral body perforation guide 1 described with reference to Figure 4 in Embodiment 1 or 4. In this embodiment 5, as described with reference to Figures 1 to 3, the diameters of the intermediate portion 13 and the terminal portion 14 of the vertebral body perforation guide 1 may be larger than the diameter of the tip spatula portion 12, but it is sufficient that the bone cement filling device 3 can pass through, for example the tip spatula portion 12, the intermediate portion 13 and the terminal portion 14 may be the same diameter.

[0123] Figure 13 is a side view showing an example configuration of a bone cement filling device 3 and a push rod 45 used with it, and Figure 14 is a cross-sectional view thereof. In Figure 14, the tip and proximal ends of the shaft 34 are shown enlarged to aid understanding. While the bone cement filling device 3 illustrated in Figure 4 is curved in a roughly S-shape overall, the bone cement filling device 3 of this embodiment 5 has a shaft 34 and a curved portion 33 sequentially from the distal end (right side of the paper) to the proximal end (left side of the paper). The shaft 34 and the curved portion 33 have hollow portions 35 and 36 that communicate from the injection port 39 on the distal side of the shaft 34 to the injection port 31 on the tip side of the curved portion 33. The curved portion 33 is curved in a direction away from the central axis of the shaft 34 (downward direction of the paper, towards the patient's tail). The bone cement filling device 3 is inserted into the vertebral body perforation guide 1 through the opening 11-3 of the distal part 14, and when it passes through the intermediate part 13, the ejection port 31 protrudes from the opening 11-1 of the tip spatula part 12.

[0124] Bone cement is injected through the injection port 39 and discharged through the hollow sections 35 and 36 to fill the vertebral body. The tip of the curved portion 33 of the bone cement filling device 3 is guided into the vertebral body, and the bone cement is discharged, allowing the bone cement to be injected into the appropriate location within the vertebral body.

[0125] This allows for the precise injection of bone cement into every corner of the vertebral body while minimizing skin incisions. In particular, it enhances safety by making it easier to remove the bone cement filling device even if it becomes embedded and fixed in the injected bone cement.

[0126] In Figures 13 and 14, the inlet 39 is shown at the distal end and the outlet 31 at the proximal end. However, the inlet 39 does not necessarily have to be located at the distal end of the shaft 34; a connecting portion 37 or other structure described later may be provided distal to the inlet 39. Furthermore, the outlet 31 does not necessarily have to be located at the proximal end of the curved portion 33; although not shown in the figures, it may be located slightly before the tip of the curved portion 33, and it does not necessarily have to be in one location; it may be provided in multiple locations.

[0127] It is more preferable to have a tapered structure in which the outer diameter decreases from the shaft 34 towards the tip of the curved portion 33. Even if the tip of the bone cement filling device 3 becomes embedded in the bone cement injected from the bone cement filling device 3 and hardens and fixes in place, the tapered structure makes it easier to remove.

[0128] The bone cement filling device 3 has a curved portion 33 that is curved away from the central axis of the shaft 34, which allows bone cement to be injected into the appropriate location within the vertebral body. However, because it is curved, it may be difficult to remove. If a part of the bone cement filling device 3, including the tip, becomes embedded in the bone cement filled within the vertebral body, and the bone cement hardens, the embedded portion may become fixed to the bone cement. Even in such a case, if the bone cement filling device is straight, it can be removed by rotating it around its central axis to release the fixation. However, if the embedded portion is curved, it cannot be rotated. When part or all of the curved portion 33 of the bone cement filling device 3 is embedded and fixed in the bone cement, even if a force is applied to rotate the shaft 34 around its central axis, it cannot be rotated, or if it can be rotated, the curved portion 33 will rotate along with the bone cement in which it is embedded. The curved portion 33 of the bone cement filling instrument 3 of the present invention has a tapered structure in which the outer diameter decreases towards the tip, making it easy to pull out by applying force in a straight line even if it cannot be rotated.

[0129] The tapered structure may extend not only to the curved portion 33 but also to the shaft 34. For example, it may be a structure having a tapered structure where the outer diameter gradually decreases from the shaft 34 to the tip of the curved portion 33. For example, as shown in the upper part of Figure 14, the tapered structure has the same diameter as the shaft 34 for 2 / 3 of the length L of the curved portion 33 on the side connected to the shaft 34, and a tapered structure for the 1 / 3 on the tip side, with the outer diameter of the tip becoming smaller. More specifically, for example, the outer diameter of the tip Φt < the outer diameter of the middle part Φm = the diameter of the part connected to the shaft 34 Φb. On the other hand, the tapered structure may be formed not only on the entire curved portion 33 but also on the tip side of the shaft 34. The length of the tapered structure and the size (angle) of the taper are appropriately designed according to the depth of embedding and the strength of fixation of the bone cement filling device 3 in the bone cement, as well as considering the force required for removal (for example, the magnitude of the impact force applied by the slap hammer 70 described later). In particular, if the curved portion 33 is small and there is a possibility that even a part of the shaft 34 may become embedded and fixed in bone cement, the tapered structure can be extended to that portion of the shaft 34 to facilitate removal.

[0130] As described above, the bone cement filling device 3 of the present invention can be easily removed from the filled bone cement in percutaneous vertebroplasty for fractures or in surgeries to reinforce vertebral bodies with bone cement.

[0131] In the bone cement filling device 3, it is preferable that the diameter of the hollow portion 35 of the shaft 34 be larger than the diameter of the hollow portion 36 of the curved portion 33. This is because it is possible to fill the shaft 34 with a larger amount of bone cement than if the entire hollow portion (35 and 36) were made of the same diameter.

[0132] The bone cement filling instrument 3 may also be equipped with a grip 32 at the distal end of the shaft 34. This makes various operations of the bone cement filling instrument 3, including removal, easier. In Figures 13 and 14, the direction of the grip 32 is shown as vertical, the same as the direction of curvature of the curved portion 33, but it is arbitrary and may be horizontal, for example, from front to back on the page. Furthermore, the injection port 39 does not need to be a symmetrical elongated shape; any shape can be adopted, such as an asymmetrical Y-shape, a circular or spherical shape, or a shape with a finger-fitting indentation for easier gripping.

[0133] The bone cement filling device 3 may be configured as described above by attaching the grip 32, the connecting part 37, or both to the distal end of the shaft 34, but in any configuration, it is necessary to attach it in a way that does not block the injection port 39. The grip 32 and the connecting part 37 may be made of plastic, for example, instead of being made of metal by welding, and a through hole matching the outer diameter of the shaft 34 may be provided in the center, and they may be attached to the distal end of the shaft 34 by adhesive or insert molding.

[0134] The bone cement filling device 3 may be configured to be used together with a pusher rod 45, as illustrated in Figures 13 and 14. The pusher rod 45 is cylindrical and can be inserted into the hollow portion 35 of the shaft 34 of the bone cement filling device 3, and is easier to operate if a grip 46 is provided at the distal end, as illustrated in Figures 13 and 14. The bone cement is pre-filled into the hollow portion 35 (or also into the hollow portion 36) of the bone cement filling device 3, and after the tip of the bone cement filling device 3 is guided into the vertebral body, the pusher rod 45 is inserted through the injection port 39 and pushed in, causing the bone cement to be injected from the injection port 31 and injected into the vertebral body.

[0135] In the bone cement filling device 3 shown in Figure 14, the inner diameter of the hollow portion 36 of the curved portion 33 is configured to gradually decrease from the connection point with the shaft 34 toward the injection port 31. By designing the inner diameter of the hollow portion 35 of the shaft 34 to match the outer diameter of the push rod 45, the bone cement filled throughout the hollow portion 35 can be pushed in by the cylindrical push rod 45 with a constant outer diameter and injected through the hollow portion 36 of the curved portion 33 toward the injection port 31, thus minimizing the amount of bone cement remaining in the tube without being injected. This bone cement filling device 3 can employ a simple manufacturing method, such as narrowing the portion that becomes the curved portion 33 from a single cylinder, which allows for relatively low manufacturing costs.

[0136] The shaft 34 and curved portion 33 of the bone cement filling device 3 are made of stainless steel, for example, and the shaft 34 is preferably straight. The push rod 45 can also be made of a straight stainless steel rod. The shaft 34 may have a slightly curved structure with a different curvature than the curved portion 33, and this may be adjusted as appropriate considering the ease of insertion of the push rod 45. The shaft 34 can be curved and the push rod 45 can be made flexible, but a straight shape can accommodate bone cement with higher viscosity.

[0137] Instead of the push rod 45, the device may be configured to allow injection of bone cement by applying pressure from the injection port 39 using a syringe or the like. Figure 15 is a cross-sectional view showing an example of the configuration of the bone cement filling device 3 of the present invention and a syringe consisting of a syringe 60 and a plunger 61 used together with it. As with Figure 14, Figure 15 shows the tip and proximal ends of the shaft 34 enlarged to aid understanding. The tip of the syringe 60 is attached to the injection port 39 of the bone cement filling device 3, and the bone cement filled in the syringe 60 is pushed out by applying pressure with the plunger 61, thereby injecting it into the bone cement filling device 3 from the injection port 39 and ejecting it from the ejection port 31 into the vertebral body. The tip shape of the syringe 60 may be configured to be a Luer taper type and inserted into the injection port 39 of the bone cement filling device 3, or a Luer lock type syringe 60 may be attached to the injection port 39 of the cement filling tube 3.

[0138] The syringe, consisting of a syringe 60 and a plunger 61, may be configured to be directly attached to the inlet 39 of the cement filling pipe 3, as in this embodiment, or it may be configured to be attached via a tube or the like.

[0139] Figure 16 is a cross-sectional view showing another configuration example of the bone cement filling device 3 and the pusher 45 used with it. The distal end of the shaft 34 of the bone cement filling device 3 is made as thick as the syringe 60 of the syringe described above, and the pusher 45 functions as the plunger 61 of that syringe. The hollow portion 35 of the shaft 34 is divided into a narrow hollow portion 35-1 that communicates with the hollow portion 36 of the curved portion 33, and a thicker hollow portion 35-2 that functions as the syringe 60 at the distal end. The thicker hollow portion 35-2 functions as a bone cement filling section with a large capacity.

[0140] A screw structure is formed by threads that interlock with each other on the inner wall of the shaft 34 in the thick hollow section 35-2 and on the outer circumference of the pusher rod 45. By rotating and screwing in the pusher rod 45, the bone cement filled in the hollow section 35-2 of the shaft 34 can be pushed out with high pressure.

[0141] This allows bone cement to be injected into the vertebral body with minimal force, even when the viscosity of the bone cement is high and the hollow portions 35 and 36 of the bone cement filling device 3 are narrow.

[0142] In Figure 16, the screw structure is formed throughout the entire thick hollow section 35-2 corresponding to the syringe 60, but it may also be formed only in a limited area, such as only at the distal end. In this case, the tip of the pusher 45 may be equipped with a rubber tip made of silicone rubber or the like, similar to a plunger.

[0143] Furthermore, although not shown in the illustration, a configuration without the screw structure can be adopted from the embodiment shown in Figure 16. Instead of attaching the syringe exemplified in Figure 15, it may be positioned as a configuration integrated with the bone cement filling device 3.

[0144] As described above, various modifications can be adopted for the method of injecting bone cement into the bone cement filling device 3. For example, the device may be configured so that a bone cement filling device that applies pressure to push out bone cement like a syringe via a tube or the like can be connected to the injection port 39 of the cement filling pipe 3.

[0145] The bone cement filling device 3 of the present invention is further preferable to have a connecting portion 37 on its distal side to which a slap hammer 70 can be connected. Figure 17 is an explanatory diagram showing an example of the configuration of the bone cement filling device 3 and the slap hammer 70 used together with it. The top section shows a side view of the bone cement filling device 3, and the middle and bottom sections show a side view and a cross-sectional view of the slap hammer 70.

[0146] The slap hammer 70 comprises a hammer shaft 71 (commonly simply called the "shaft," but referred to as the "hammer shaft" in this specification to clearly distinguish it from the shaft 34 of the bone cement filling instrument 3), a sliding part 72, a grip 73, and an impact part 74. The sliding part 72 is a heavy cylindrical part, mounted so that the hammer shaft 71 passes through a through hole in the center of the cylinder, and can slide along the hammer shaft 71. When the sliding part 72 slides and collides with the grip 73 provided at the end of the hammer shaft 71, it transmits the impact force to other connected instruments. Since the weight of the sliding part 72 affects the impact force, in order to apply a large impact force, a relatively heavy metal such as stainless steel may be selected as the material for the sliding part 72, and the grip portion may be covered with plastic resin to make it easy to hold and less slippery.

[0147] Preferably, the impact portion 74 at the tip of the slap hammer 70 is configured to be connectable to the connection portion 37 of the bone cement filling device 3. The connection mechanism is arbitrary; for example, the connection portion 37 is an annular projection provided at the distal end of the shaft 34, and the impact portion 74 at the tip of the slap hammer 70 is configured to clamp this annular projection from both the shaft 34 side and the distal side. A grip 73 is attached to the distal end of the slap hammer 70, and the impact force generated when the sliding portion 72 slides and collides with the grip 73 is transmitted from the connection portion 37 through the shaft 34 to the curved portion 33, and this impact force allows the curved portion 33 to be detached from the bone cement without rotating it.

[0148] This makes it possible to remove the bone cement filling device 3 even if the tip of the bone cement filling device 3 becomes embedded in the bone cement filling the vertebral body and hardens and becomes fixed in place.

[0149] The slap hammer 70 may be configured to be connectable to a bone cement filling device 3, such as the one illustrated in Figure 16, in which the distal end of the shaft 34 has a large-capacity bone cement filling section, similar to a syringe.

[0150] [Embodiment 6] Vertebral Drilling Guide and Inner Pipe As described in Embodiments 1 to 5 above, the vertebral drilling guide 1 of the present invention functions as a guide that defines the trajectory when a curved vertebral processing instrument (bone drilling instrument 2, bone cement filling instrument 3, etc.) is inserted into the vertebral body. By designing it appropriately, the incision required to insert the instrument into the patient's body can be minimized, and even in such cases, the tip of the vertebral processing instrument can be guided to any location within the vertebral body. Here, "processing" of the vertebral processing instrument should be interpreted broadly, and is not limited to physically processing the body tissue that constitutes the spine, but broadly includes any medical procedure that is inserted into the vertebral body and performed.

[0151] As illustrated in Figures 1-3, the vertebral body drilling guide 1, which has an opening 11-2 in its intermediate section 13, allows the vertebral body processing instrument to pass through the relatively large opening 11-2, as explained with reference to Figure 5. The outside of the intermediate section 13 is usually soft, consisting of muscles on the patient's back, so there is no problem even if the vertebral body processing instrument passes through it. However, if the passing vertebral body processing instrument has a protrusion, and if the muscles on the outside of the intermediate section 13 are pushed into the opening 11-2 of the intermediate section 13, it cannot be said that there is absolutely no risk of the passing vertebral body processing instrument getting caught on the muscles and even injuring them. One solution to this problem is to adopt a vertebral body drilling guide 1 without an opening in the intermediate section 13, as illustrated in Figure 11, as shown in Embodiment 4.

[0152] Furthermore, if an opening 11-2 is provided in the middle section 13 of the vertebral body perforation guide 1, it cannot be said that there is absolutely no risk that the linear vertebral body processing instrument may come into contact with and damage muscle tissue that enters through the opening 11-2 when passing through, or that the tip of the linear vertebral body processing instrument may protrude from the opening 11-2 and get caught on the vertebra outside the bone hole formed in the pedicle.

[0153] Figure 18 is an explanatory diagram showing one example configuration of the vertebral body perforation guide 1 and inner pipe 8 of the present invention. The top row [A] is a side view of the vertebral body perforation guide 1, the second row [B] is a side view of the inner pipe 8, and the third row [C] and the bottom row [D] are a side view and a cross-sectional view showing the vertebral body perforation guide 1 and the inner pipe 8 inserted and connected to form an integrated unit.

[0154] The vertebral body perforation guide 1 has a similar form to those illustrated in Figures 1 to 3, and is a hollow cylindrical shape along its central axis, with a tip spatula portion 12, an intermediate portion 13, and a terminal portion 14 along its central axis in order from the proximal side. The tip spatula portion 12 and the terminal portion 14 have openings 11-1 and 11-3 facing downward perpendicular to the central axis, while the intermediate portion 13 has an opening 11-2 facing upward in the opposite direction, and its inner diameter is larger than that of the tip spatula portion 12. The opening 11-3 of the terminal portion 14 may extend over the entire terminal portion 14, as illustrated in Figure 1, etc., but it may also be limited to the proximal side near the intermediate portion 13, as illustrated in Figure 18. This prevents an opening from being formed at the distal end of the terminal portion 14 of the vertebral body perforation guide 1, thereby increasing its mechanical strength. The configuration is not limited to the form with a grip 18 as illustrated in Figure 18. In particular, when there is no grip 18, the operator will grasp the distal end 14, so it is easier to handle if the opening 11-3 does not extend to the distal end.

[0155] The inner pipe 8 is cylindrical along its central axis and has a side wall 81 that closes the opening 11-2 of the intermediate section 13 when inserted into the terminal section 14 and intermediate section 13 of the vertebral perforation guide 1 along its central axis, and a hollow section 82 that communicates with the hollow of the tip spatula section 12. As will be shown in Figure 19 later, the size of the side wall 81 does not necessarily have to be large enough to completely close the opening 11-2 of the intermediate section 13. In other words, the side wall 81 should be large enough to close the opening 11-2 so that there is no large gap that would allow a device such as a balloon catheter passed through the inner pipe 8 to protrude out of the remaining opening 11-2 of the intermediate section 13.

[0156] This provides a safer treatment device that eliminates concerns about the vertebral body processing instrument getting caught on the opening 11-2 of the intermediate section 13 or surrounding tissue, or even damaging surrounding muscles, when guiding the vertebral body processing instrument into the vertebral body using the vertebral body perforation guide 1 with an opening in the intermediate section 13. This is particularly effective when guiding linear instruments such as balloon catheters into the vertebral body.

[0157] The central axes of the vertebral body perforation guide 1 and the inner pipe 8 do not need to coincide precisely, but it is desirable that they coincide. Also, as shown in the cross-sectional view of Figure 18[D], the outer diameter of the inner pipe 8 should be slightly smaller than the inner diameter of the terminal portion 14 and the intermediate portion 13 of the vertebral body perforation guide 1, so as to avoid excessive friction during insertion and to prevent rattling once inserted. Furthermore, it is preferable that the inner diameter of the inner pipe 8 matches the inner diameter of the tip spatula portion 12 of the vertebral body perforation guide 1, so that when the inner pipe 8 is inserted into the vertebral body perforation guide 1, the inner wall 81 of the inner pipe 8 and the inner wall of the tip spatula portion 12 of the vertebral body perforation guide 1 smoothly connect and become continuous. In addition, it is preferable that the proximal end of the intermediate portion 13 of the vertebral body perforation guide 1 has a so-called constricted shape with a slope that reduces the diameter in order to connect with the tip spatula portion 12, and that it is configured to contact the tip portion of the inner pipe 8. As a result, it is preferable that the tip of the inner pipe 8 has a curved shape, as illustrated in Figure 14, such that the upper part abuts against the distal end of the tip spatula portion 12 of the vertebral body perforation guide 1, and the lower part abuts against the connection point with the tip spatula portion 12 along the inner wall of the intermediate portion 13. This reduces the risk of instruments getting caught at the point where the tip spatula portion 12 of the vertebral body perforation guide 1 and the inner pipe 8 come into contact.

[0158] [Integration of vertebral body perforation guide and inner pipe] The vertebral body perforation guide 1 and the inner pipe 8 are each equipped with connecting parts 17 and 87 that can be connected to each other, thereby enabling the vertebral body perforation guide 1 and the inner pipe 8 to be integrated.

[0159] The specific structure of the connection part is arbitrary, but for example, as illustrated in Figure 18, it can be configured by providing a connection part 17 on the grip 18 of the vertebral body drilling guide 1 and a connection part 87 on the grip 88 of the inner pipe 8. The connection part 87 of the inner pipe 8 is, for example, an elastic body with a protrusion at its tip, which is designed to bend slightly outward when passing through the connection part 17 of the vertebral body drilling guide 1, and to engage with the protrusion after passing through the protrusion of the connection part 17 to be fixed (latched). As in this example, the vertebral body drilling guide 1 and the inner pipe 8 are provided with grips 18 and 88 at their respective distal ends, and when connected and integrated, the grips 18 and 88 are also integrated, making them a shape suitable for gripping and operating the vertebral body drilling guide 1 and the inner pipe 8.

[0160] The connection structure, including grips 18 and 88, is arbitrary. For example, grips 18 and 88 may be provided with a structure that allows them to fit together, or they may be connected by a screw structure.

[0161] Figure 19 is an explanatory diagram showing another configuration example of the vertebral body drilling guide 1 and inner pipe 8 of this embodiment. A screw-type connection structure is employed. A male threaded connection part 17 is provided on the distal side of the grip 18 of the vertebral body drilling guide 1, and the vertebral body drilling guide 1 and the inner pipe 8 are connected by screwing it into a female threaded connection part 87 formed by hollowing out the inside of the grip 88 of the inner pipe 8. The grip 18 itself may be the male threaded connection part 17. Specifically, by holding the grip 88 and rotating the inner pipe 8 along its central axis while inserting it into the vertebral body drilling guide 1, the female threaded connection part 87 and the male threaded connection part 17 are screwed together and connected, and the vertebral body drilling guide 1 and the inner pipe 8 are integrated. The relationship between the male and female threads may be reversed. In place of the screw structure, other connection structures such as a connection using an L-shaped groove and projection may be employed.

[0162] In Figure 19, the side wall 81 of the inner pipe 8 is not large enough to completely block the opening 11-2 of the intermediate section 13 of the vertebral body perforation guide 1, but is slightly shorter, leaving a small opening on the proximal end side of the opening 11-2 of the intermediate section 13. Also, although the vertebral body perforation guide 1 in Figure 19 has an opening 11-3 throughout the entire terminal section 14, the opening 11-3 may be limited to the proximal side, similar to the vertebral body perforation guide 1 in Figure 18.

[0163] The other configurations are the same as in Figure 18, so their explanation will be omitted.

[0164] The connection structure between the vertebral body perforation guide 1 and the inner pipe 8 is arbitrary, and combinations other than those shown in Figures 18 and 19 above can be arbitrarily adopted, such as whether the side wall 81 of the inner pipe 8 completely seals the opening 11-2 of the intermediate portion 13 or leaves a gap, or whether the opening 11-3 of the terminal portion 14 of the vertebral body perforation guide 1 is limited to the proximal side or covers the entire terminal portion 14.

[0165] Furthermore, the shape of the grip 18 of the vertebral body perforation guide 1 is arbitrary, and may be configured to have the functions of a support portion 15 and a gripping portion 16 as illustrated in Figure 6.

[0166] Figure 20 is an explanatory diagram showing yet another configuration example of the vertebral body perforation guide 1 and inner pipe 8 of the present invention. In Figures 18 and 19, when the inner pipe 8 is inserted into the vertebral body perforation guide 1, its tip remains at the tip of the intermediate section 13, and the hollow section 82 of the inner pipe 8 communicates with the tip spatula section 12 of the vertebral body perforation guide 1, which is effective when guiding a linear instrument such as a balloon catheter into the vertebral body. In the inner pipe 8 illustrated in Figure 20, the tip extends to the tip of the tip spatula section 12 of the vertebral body perforation guide 1. Alternatively, it may protrude even further than the tip spatula section 12. The other main configurations are the same as in Figure 18, so their explanation is omitted.

[0167] This eliminates the connection point from the hollow section 82 to the terminal spatula section 12, which is effective in completely eliminating the possibility of the connection point getting caught when guiding a straight instrument such as a balloon catheter into the vertebral body. It also contributes to the efficiency of the procedure. The vertebral body perforation guide 1 and the inner pipe 8 are inserted into the vertebral body as a single unit or sequentially, and after performing the necessary treatment (processing) inside the vertebral body using a straight instrument such as a balloon catheter, the straight instrument and then the inner pipe 8 are removed, and the remaining vertebral body perforation guide 1 can be used to guide a curved vertebral body processing instrument such as Embodiment 1 into the vertebral body.

[0168] Furthermore, the inner diameters of the intermediate section 13 and the terminal section 14 of the vertebral body perforation guide 1 may be made the same as the inner diameter of the tip spatula section 12, in accordance with the outer diameter of the inner pipe 8 through which it passes. The optimal diameter can be selected as appropriate, taking into consideration the overall strength, including the outer diameter.

[0169] [Procedure using the inner pipe] Figures 21 and 22 are explanatory diagrams showing the main steps in the procedure for using the vertebral body perforation guide 1 and the inner pipe 8. Figure 21 is the first half, and Figure 22 is the second half. Similar to Figures 8 and 9, it schematically represents the vertebral body, which is the affected area, viewed fluoroscopy from the left side of the patient while the patient is standing, with the left being the ventral side, the right being the dorsal side, the top being the cranial side, and the bottom being the caudal side. It is constructed by modifying some of the procedures of Embodiment 2 shown in Figures 8 and 9.

[0170] Step [1] in Figure 21 involves inserting the vertebral body drilling guide 1 into the bone hole of the pedicle after opening the wound and forming a bone hole in the pedicle as in Step [1] in Figure 8. Next, the inner pipe 8 is inserted into the vertebral body drilling guide 1 to integrate them, and then the inner needle 4 is inserted and introduced into the vertebral body to grind the inside of the vertebral body. The vertebral body drilling guide 1 and the inner pipe 8 may be inserted into the bone hole of the pedicle with the vertebral body drilling guide 1 and inner pipe 8 already integrated. Alternatively, the vertebral body drilling guide 1, inner pipe 8, and inner needle 4 may be pre-assembled, and then the vertebral body drilling guide 1 and inner pipe 8 may be inserted into the bone hole of the pedicle while grinding with the inner needle 4.

[0171] Step [2]: Remove the inner needle 4.

[0172] Step [3]: Insert the balloon catheter 5 into the vertebral body perforation guide 1 and the inner pipe 8, and guide the balloon 51 into the vertebral body.

[0173] Step [4] (Figure 22): Once the balloon 51 reaches the desired position within the vertebral body, the balloon 51 is inflated to form a cavity within the vertebral body 90. If the vertebral body 90 is deformed due to a compression fracture, the pressure from the balloon 51 restores it to its original size.

[0174] Steps [3] and [4] are the same as step [3] in Figure 8, but the presence of the inner pipe 8 prevents the balloon 51 from accidentally protruding from the opening 11-2 of the vertebral perforation guide 1 when the balloon catheter 5 is inserted, and prevents the balloon 51 from getting caught on the distal end of the opening 11-2 and being damaged when it is removed.

[0175] Step [5]: After removing the balloon catheter 5, remove the inner pipe 8. Alternatively, the inner pipe 8 may be removed at the same time as the balloon catheter 5. Then, insert the curved bone drilling instrument 2 and guide its tip to the desired position inside the vertebral body to grind the inside of the vertebral body. Similar to steps [3] to [5] in Figure 8, multiple bone drilling instruments 2-1 to 2-3 with different curvature sizes may be appropriately selected and used alternately to grind every corner of the vertebral body sequentially.

[0176] Step [6]: After removing the bone drilling instrument 2, insert the bone cement filling instrument 3 and guide its tip to the desired position within the vertebral body to fill the desired position with bone cement. Similar to steps [6] to [8] in Figure 8, multiple bone cement filling instruments 3-1 to 3-3 with different curvature sizes may be appropriately selected and used alternately to sequentially fill every corner of the vertebral body with bone cement.

[0177] Subsequently, the vertebral body perforation guide 1 may be removed and the wound closed to complete the surgery. Alternatively, a step may be performed in which screws are screwed into the filled bone cement from the pedicle 91 side, either through the vertebral body perforation guide 1 or using another instrument. In addition, this procedure may be used in combination with other procedures. Other procedures may include, for example, the implantation of a spinal cage or artificial intervertebral disc implant in the intervertebral space between the lower endplate 92b and the vertebral body further below. Other procedures may include, for example, vertebral fusion surgery in which similar procedures are performed on multiple vertebral bodies and then they are fixed with rods.

[0178] Although the present inventor's invention has been specifically described above based on embodiments, it goes without saying that the present invention is not limited thereto and can be modified in various ways without departing from its essence.

[0179] The present invention relates to a spinal treatment device for filling the spine with bone cement, and is particularly suitable for use in surgeries to stabilize and reinforce the spine.

[0180] 1 Vertebral body perforation guide 2, 2-1, 2-2 Bone perforation instrument 3, 3-0, 3-1, 3-2 Bone cement filling instrument 4 Inner needle 5 Balloon catheter 8 Inner pipe 9 Guide pin 11-1, 11-2, 11-3 Opening 12 Tip spatula 13 Middle section 14 Terminal section 15 Support section 16 Gripping section 17 Connection section (with inner pipe) 18 Grip 21 Tip section 41 Bone perforation section 22, 32, 42, 46 Grip 31 Outlet 33 Curved section 34 Shaft 35, 35-1, 35-2, 36 Hollow section 37 Connection section 39 Injection port 45 Pusher 49 Through hole 51 Balloon 52 Balloon inflator 53 Balloon catheter delivery tube 60 Syringe (bone cement filling part) 61 Plunger (bone cement insertion part) 70 Slap hammer 71 Hammer shaft 72 Sliding part 73 Grip 74 Impact part 81 Side wall 82 Hollow part 87 Connection part (with inner pipe vertebral body perforation guide) 88 Grip 90 Vertebral body 91 Pedicle 92 Endplate 92t Upper endplate 92b Lower endplate 97 Bone cement 98 Incision site 99 Skin 100 Treatment instrument

Claims

1. A therapeutic instrument comprising a vertebral body drilling guide and a vertebral body processing instrument, wherein the vertebral body drilling guide is a hollow cylindrical shape along a central axis and has a tip spatula portion, a middle portion and a terminal portion in order from the proximal side along the central axis, the tip spatula portion opens in a direction perpendicular to the central axis, the terminal portion has an opening in a direction perpendicular to the central axis, the inner diameter of the middle portion in the perpendicular direction is larger than the inner diameter of the tip spatula portion, and the vertebral body processing instrument is rod-shaped and has a curved portion that curves in the direction perpendicular to the central axis, is inserted into the vertebral body drilling guide from the terminal portion along the central axis, and when it passes through the middle portion along the central axis, its tip protrudes from the opening of the tip spatula portion.

2. The treatment device according to claim 1, wherein the intermediate portion of the vertebral body perforation guide opens in the direction opposite to the vertical direction.

3. The therapeutic instrument according to claim 1, wherein the vertebral body perforation guide has a support portion at its distal end that extends in the vertical direction and allows the vertebral body processing instrument to pass through.

4. The treatment device according to claim 1, wherein the cross-sectional shape of the hollow vertebral body perforation guide perpendicular to the central axis is circular.

5. A therapeutic device according to any one of claims 1 to 4, further comprising an inner needle and a balloon catheter, wherein the inner needle and the balloon catheter are configured such that their respective tips can protrude from the tip of the tip spatula when the hollow is inserted along the central axis, and the vertebral body processing device comprises a bone drilling device and a bone cement filling device.

6. The treatment instrument according to claim 5, wherein the vertebral body processing instrument further includes a balloon catheter delivery tube, and the balloon catheter is configured such that its tip can protrude from the tip spatula when inserted into the balloon catheter delivery tube.

7. The treatment instrument according to claim 5, wherein the inner tube needle is hollow along the central axis and has a through hole through which a guide pin can be passed along the central axis.

8. A treatment device comprising a vertebral body drilling guide and a bone cement filling device, wherein the vertebral body drilling guide is a hollow cylindrical shape along a first central axis and has a tip spatula portion, an intermediate portion and a terminal portion in order from the proximal side along the first central axis, the tip spatula portion and the terminal portion each open in a first direction perpendicular to the first central axis, the intermediate portion has an opening in a second direction opposite to the first direction, the bone cement filling device has a shaft having a second central axis sequentially from the distal side to the proximal side and a curved portion that curves away from the second central axis at the tip, the shaft has a bone cement injection port on the distal side and the curved portion has a bone cement injection port on the proximal side and the shaft and the curved portion have a hollow portion communicating from the injection port to the injection port, The bone cement filling device is a treatment device that is inserted into the vertebral body perforation guide from its distal end along the first central axis, and when it passes through the intermediate part along the first central axis, the ejection port protrudes from the opening of the tip spatula.

9. The treatment device according to claim 8, wherein the opening of the terminal portion of the vertebral body perforation guide is formed to be localized to the proximal side.

10. The therapeutic instrument according to claim 8 or 9, wherein the shaft further comprises a connecting portion distal to which a slap hammer can be connected.

11. The treatment instrument according to claim 8 or 9, wherein the bone cement filling instrument further comprises a bone cement indentation portion, the shaft comprises a bone cement filling portion distal to the shaft, and the bone cement indentation portion is inserted into the hollow portion of the bone cement filling portion and configured to push the bone cement filled in the hollow portion from the injection port into the hollow portion of the curved portion.

12. The treatment device according to claim 11, wherein the outer circumference of the bone cement pressing portion and the inner surface of the hollow portion of the shaft constituting the bone cement filling portion have screw threads that screw into each other.

13. The treatment instrument according to claim 11, wherein the bone cement filling instrument further comprises a connecting portion on the distal side of the shaft to which a slap hammer can be connected.

14. A therapeutic instrument comprising a vertebral body drilling guide and an inner pipe for guiding a vertebral body processing instrument having a curved portion that curves in a direction perpendicular to a first central axis into the vertebral body, wherein the vertebral body drilling guide is a hollow cylindrical shape along a second central axis and has a tip spatula portion, an intermediate portion and an distal portion in order from the proximal side along the second central axis, the tip spatula portion and the distal portion have openings in a first direction perpendicular to the second central axis, the intermediate portion has an opening in the opposite direction to the first direction, the inner diameter of the intermediate portion is larger than the inner diameter of the tip spatula portion, and the inner pipe is a cylindrical shape along a third central axis and has side walls that close the opening of the intermediate portion when inserted into the distal portion and the intermediate portion along the second central axis.

15. The treatment instrument according to claim 14, wherein the inner pipe is cylindrical along a third central axis and has a hollow portion that communicates with the hollow portion of the tip spatula when inserted along the second central axis at the end and the middle portion.

16. The therapeutic device according to claim 14, wherein the opening of the terminal portion of the vertebral body perforation guide is formed to be localized to the proximal side.

17. The treatment device according to claim 14, wherein each of the vertebral body perforation guide and the inner pipe has a connecting portion that can be connected to each other.

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