Bone cement filling tube and treatment instrument including same
Patent Information
- Application Number
- PCT/JP2025/012133
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-03-26
- Publication Date
- 2026-10-01
Smart Images

Figure JP2025012133_01102026_PF_FP_ABST
Abstract
Description
Bone cement filling tube and therapeutic instrument comprising the same
[0001] The present invention relates to a bone cement filling tube for filling bone cement into the spine (also referred to as "vertebral body") and a therapeutic instrument comprising the same, and is particularly suitable for use in surgery for stabilizing and reinforcing the spine before fracture treatment and insertion of spinal cages or artificial intervertebral discs.
[0002] One of the therapeutic methods for spinal treatment is percutaneous vertebroplasty. This is a surgical procedure in which a balloon catheter is inserted into a fractured site, the balloon is inflated 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 placement of a screw or instrument in the pedicle of a selected spinal region during surgery. A full-scale three-dimensional image of a vertebra in the spinal region is generated, the vertebra in the three-dimensional image is hollowed out according to the cortical wall thickness selected by a surgeon, the isthmus of each pedicle is determined, and then the ideal diameter, length and / or trajectory of a pedicle screw or instrument is determined.
[0004] Patent Document 2 discloses a method and a device for treating intervertebral disc diseases. The method for performing transpedicular discectomy disclosed in said patent document comprises the steps of: forming a transpedicular channel through the pedicle of a vertebra to the vertebral body; inserting a flexible cone through the transpedicular channel, causing the flexible cone to form an angle of about 90 degrees, and penetrating the vertebral body with the flexible cone to form a channel into the intervertebral disc; and removing a part of the intervertebral disc with a laser device.
[0005] Japanese National Publication No. 2008-537496 Japanese National Publication No. 2007-526001
[0006] The biggest drawback of percutaneous vertebroplasty is that a certain proportion of adjacent vertebral bodies fracture after surgery (adjacent vertebral body fracture). Recent studies have gradually revealed the risk of postoperative adjacent vertebral body fracture. However, during the initial percutaneous vertebroplasty, there is no appropriate therapeutic instrument for reinforcing and stabilizing adjacent vertebral bodies and adjacent intervertebral spaces in advance to reduce the risk of adjacent vertebral body fracture.
[0007] 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 at the center of the vertebral body (see paragraph 0124, Figures 38a-b, 39a-b, etc.). However, this technology is intended to position the balloon at the center of the vertebral body and cannot be applied to instruments for precisely excavating specific locations throughout the vertebral body.
[0008] 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 the flexible drill tip inside the vertebral body to reach the drilling site (Figures 30-32, etc.). This allows for precise drilling of the intended location throughout the vertebral body, and because the path from the skin to the pedicle is linear, it is expected that skin incisions can be kept to a minimum. However, since the device is introduced into the vertebral body along a linear retaining tube and deforms within the vertebral body, there is a risk that the retaining tube will not return to its original straight cylindrical shape when removed, and that the deformation may not return to its original state depending on the condition of the bone inside, making removal difficult.
[0009] The inventors identified a problem in the lack of a suitable treatment instrument that could accurately excavate the intended location within the vertebral body as a pretreatment for reinforcing the vertebral body by replacing its interior with bone cement without damaging its normal shape. Therefore, they invented a treatment instrument including a vertebral body drilling guide and a vertebral body processing instrument, and filed patent applications as International Patent Application PCT / JP2024 / 003649 and Japanese Patent Application No. 2024-177822.
[0010] The vertebral body drilling guide of this invention is a hollow cylindrical shape along a central axis, and along its central axis, it has a tip spatula section, a middle section, and a terminal section in order from the proximal side. The tip spatula section opens perpendicular to the central axis, and the terminal section has an opening on the proximal side perpendicular to the central axis. The opening of the terminal section may be open to the entire terminal section or only to a part of it. The inner diameter of the middle section in the vertical direction is larger than the inner diameter of the tip spatula section. The vertebral body processing instrument is rod-shaped, smoothly curved perpendicular to the central axis, inserted into the vertebral body drilling guide from the terminal section along the central axis, and when it passes through the middle section along the central axis, the tip protrudes from the opening of the tip spatula section.
[0011] One type of vertebral body processing instrument includes a bone cement filling tube. The bone cement filling tube is a hollow cylindrical shape along its central axis, with a bone cement injection port at the distal end and a bone cement injection port at the proximal end, and is curved downward along its central axis, i.e., towards the center of the vertebral body. The bone cement that has been pre-filled inside the bone cement filling tube may be pushed out from the injection port with a pushing rod, or it may be configured so that the bone cement is pushed in from the injection port under pressure using a syringe or the like and injected from the injection port.
[0012] 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.
[0013] The inventors of this invention have noticed that the tip of a bone cement filling tube may become embedded in the bone cement it is filled with, and that once the bone cement hardens, there is a risk that it will become difficult to remove the bone cement filling tube. Bone cement is discharged forward from the tip of the bone cement filling tube, but because the vertebral body is a closed space, the filled bone cement spreads towards the bone cement filling tube, and as a result, it may cover the tip of the bone cement filling tube. As the bone cement hardens further, it adheres to the tip of the bone cement filling tube, increasing friction and making it difficult to pull out. With conventional treatment instruments that are different from the vertebral body drilling guide and vertebral body processing instrument described above, if the bone cement filling tube is straight, the embedded tubular portion can be rotated along the central axis to detach it from the bone cement and easily pull it out. On the other hand, if the bone cement filling tube is curved, it cannot be rotated along the central axis, which may make removal difficult.
[0014] The inventors realized that the same problem occurs not only when used with the vertebral body perforation guide described above, but also when the bone cement filling tube is curved.
[0015] The objective of the present invention is to facilitate the removal of a curved bone cement-filled tube from the bone cement used in percutaneous vertebroplasty for fractures or in surgeries to prophylactically reinforce vertebral bodies with bone cement.
[0016] The means for solving these problems are described below, but other problems and novel features will become apparent from the description and accompanying drawings in this specification.
[0017] According to one embodiment of the present invention, the following applies:
[0018] In other words, one embodiment of the present invention is a bone cement filling tube having a shaft and a curved portion sequentially from the distal end to the proximal end. The shaft has a bone cement injection port on the distal end, and the curved portion has a bone cement injection port on the proximal end, and the shaft and the curved portion have a hollow portion that communicates from the injection port to the injection port. The curved portion is curved in a direction away from the central axis of the shaft and has a tapered structure in which the outer diameter decreases towards the tip.
[0019] Another embodiment of the present invention is a therapeutic instrument comprising the bone cement filling tube and a vertebral body drilling guide described above, wherein, with the central axis of the shaft as the first central axis, the vertebral body drilling guide is a hollow cylindrical shape along the second central axis, having a tip portion that opens perpendicular to the central axis at the tip end along the second central axis, and an intermediate portion that opens in the opposite direction to the perpendicular direction at the root end along the central axis. When the bone cement filling tube is inserted into the vertebral body drilling guide from the distal side of the intermediate portion along the second central axis, the tip portion protrudes from the opening of the tip portion.
[0020] The effects obtained by the above embodiment can be briefly described below.
[0021] In other words, in curved bone cement-filled tubes used in percutaneous vertebroplasty for fractures or in surgeries to reinforce vertebral bodies with bone cement, it is possible to easily remove them from the filled bone cement.
[0022] The effects obtained by the aforementioned alternative embodiment can be briefly described below.
[0023] This treatment device allows for the precise injection of bone cement into every corner of the vertebral body while minimizing skin incisions, thereby significantly improving safety.
[0024] Figure 1 is a side view showing an example configuration of the bone cement filling tube and the pressing rod used therewith according to the present invention. Figure 2 is a cross-sectional view showing an example configuration of the bone cement filling tube and the pressing rod used therewith according to the present invention. Figure 3 is a cross-sectional view showing another example configuration of the bone cement filling tube and the pressing rod used therewith according to the present invention. Figure 4 is a cross-sectional view showing an example configuration of the bone cement filling tube and the syringe used therewith according to the present invention. Figure 5 is a side view and a cross-sectional view showing an example configuration of the bone cement filling tube and the slap hammer used therewith according to the present invention. Figure 6 is a cross-sectional view showing an example configuration of the bone cement filling tube of the present invention, comprising a bone cement filling section and a bone cement pressing section. Figure 7 is a cross-sectional view showing another example configuration of the bone cement filling tube of the present invention, comprising a bone cement filling section and a bone cement pressing section. Figure 8 is an explanatory diagram showing an example configuration of a treatment device of the present invention, including a bone cement filling tube, in a perspective view. Figure 9 is a schematic diagram illustrating the procedure for guiding a bone drilling instrument into the vertebral body using a vertebral body drilling guide and excavating the inside of the vertebral body to form a cavity (empty space) using the treatment instrument of the present invention. Figure 10 is a schematic diagram illustrating the procedure for guiding a bone cement filling tube into the vertebral body using a vertebral body drilling guide using the treatment instrument of the present invention. Figure 11 is an explanatory diagram showing the main steps (first half) of the surgical procedure using the treatment instrument of the present invention. Figure 12 is an explanatory diagram showing the main steps (second half) of the surgical procedure using the treatment instrument of the present invention. Figure 13 is an explanatory diagram showing the procedure for removing a bone cement filling tube from the bone cement using a slap hammer when the bone cement filling tube of the present invention has become fixed to the bone cement.
[0025] 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.
[0026] [1] Bone cement filling tube including a curved filling tube (Figures 1-7) A typical embodiment disclosed in this application is a bone cement filling tube (3), which is configured as follows.
[0027] The bone cement filling tube has a shaft (34) and a curved portion (33) sequentially from the distal end to the proximal end. The shaft has a bone cement injection port (39) on the distal end, and the curved portion has a bone cement injection port (31) on the proximal end. The shaft and the curved portion have hollow sections (35, 36) that communicate from the injection port to the injection port. The curved portion is curved away from the central axis of the shaft and has a tapered structure in which the outer diameter decreases from the shaft to the tip.
[0028] This makes it easier to remove the curved bone cement-filled tube from the bone cement used in percutaneous vertebroplasty for fractures and surgeries to reinforce vertebral bodies with bone cement. Although not shown in the illustration, the tapered structure may also be present in the straight section, or it may be a structure having a tapered structure in which the outer diameter decreases sequentially from the straight section to the tip of the curved section.
[0029] [2] Shape of the hollow portion of the curved section from the shaft (Figure 2) In the bone cement filling tube (3) of [1], the diameter of the hollow portion of the curved section gradually decreases toward the injection port.
[0030] This simplifies the manufacturing method of bone cement-filled tubes and reduces manufacturing costs. The diameter of the hollow section may be constant in the shaft portion and gradually decrease in the curved portion, or it may gradually decrease from the proximal side of the shaft. In the section where the inner diameter of the hollow section is constant, the filled bone cement can be pushed out with a cylindrical pushing rod, so the longer the section, the greater the amount of bone cement that can be filled.
[0031] [3] Large-diameter hollow section (Figure 3) In the bone cement-filled tube (3) of [1], the diameter of the hollow section (35) of the shaft is larger than the diameter of the hollow section (36) of the curved section.
[0032] This allows for a greater amount of bone cement to be filled into the shaft of the filling tube compared to constructing the entire hollow section with the same narrow diameter as the curved section.
[0033] [4] Intermediate section with the same small diameter as the curved section (Figure 4) In the bone cement filling tube (3) of [1], the diameter of the hollow section (35) of the shaft is the same as the diameter of the hollow section (36) of the curved section. The stainless steel material of the bone cement filling tube is curved after being pre-machined to the same diameter. Because the diameter of the shaft section is small, the required amount of bone cement is injected with a syringe rather than a push rod.
[0034] [4] Handle (Figures 1-4) In the bone cement filling tube (3) of any one of items [1] to [3], a handle (32) is further provided at the distal end of the shaft.
[0035] This makes it easier to perform various operations, including the removal of bone cement filling tubes.
[0036] [5] Tapered structure extending to the shaft In the bone cement filling tube (3) of any one of items [1] to [4], the tapered structure extends to the proximal side of the shaft.
[0037] This makes it easier to remove the bone cement-filled tube even if it becomes deeply embedded and fixed in bone cement to the proximal side of the shaft.
[0038] [6] Slap hammer connection part (Figure 5) In the bone cement filling tube (3) of any one of [1] to [5], the shaft is provided with a connection part (37) distal to which a slap hammer (70) can be further connected.
[0039] This allows for the application of an impact that can break the adhesion of the bone cement to the bone cement, even if the tip of the bone cement filling tube becomes embedded in the bone cement filling the vertebral body and the bone cement hardens, making it possible to remove the bone cement filling tube.
[0040] [7] Bone cement filling part and bone cement pushing part (Figs. 6 to 7) In the bone cement filling tube (3) according to any one of [1] to [5], the bone cement filling tube further comprises a bone cement pushing part (66), and the shaft comprises a bone cement filling part (65) on a distal side. The bone cement pushing part is inserted into a hollow part of the bone cement filling part, and pushes the bone cement filled into the hollow part from an injection inlet to the hollow part of the curved part. In this case, bone cement may be pre-filled not only in the bone cement filling part but also in the hollow part (35) of the shaft and the hollow part (36) of the curved part.
[0041] Thereby, a large volume of bone cement can be filled. A proximal side of the shaft connected to the curved part may be a conduit (64) having a small inner diameter of the hollow part, or the entire hollow part of the shaft may be used as the bone cement filling part (65).
[0042] [8] Pushing of bone cement by screw structure (Fig. 7) In the bone cement filling tube (3) according to [7], an outer circumference of the bone cement pushing part and an inner wall of the hollow part of the shaft constituting the bone cement filling part have screw threads that are screwed to each other.
[0043] Thereby, pressure can be applied to push the bone cement and smoothly extrude it from an ejection opening.
[0044] Although illustration is omitted, the threaded portion in the bone cement filling part (65) may be provided locally on the distal side or an intermediate part of the bone cement filling part.
[0045] [9] Slap hammer connection part (Figs. 5 to 7) In the bone cement filling tube (3) according to [7] or [8], the shaft further comprises a connection part (37) capable of connecting a slap hammer (70) on a distal side of the bone cement filling part.
[0046] Thereby, even when the tip of the bone cement filling tube is buried in the bone cement filled into a vertebral body and the bone cement is hardened, an impact capable of breaking the adhesion of the bone cement can be applied to the bone cement filling tube, allowing the bone cement filling tube to be removed.
[0047]
[10] A therapeutic instrument combined with a vertebral body perforation guide (Figures 8 to 12) A therapeutic instrument (100) comprising the bone cement filling tube (3) according to any one of [1] to [9] and the vertebral body perforation guide (1), configured as follows. The central axis of the shaft is referred to as the first central axis.
[0048] The vertebral body perforation guide is in the shape of a hollow cylinder along a second central axis, and includes a distal end portion (12) opening in a direction perpendicular to the second central axis on the distal end side along the second central axis, and a distal intermediate portion (13) along the second central axis. When the bone cement filling tube is inserted into the vertebral body perforation guide along the second central axis from the distal side of the intermediate portion of the vertebral body perforation guide, a distal end portion of the bone cement filling tube protrudes from the opening of the distal end portion.
[0049] The intermediate portion (13) of the vertebral body perforation guide (1) may be provided with an opening (11-2) that opens in a direction opposite to the opening of the distal end portion (12). Furthermore, as will be described later in [6], a terminal end portion (14) that opens in the same direction as the distal end portion may be further provided on the distal side of the intermediate portion.
[0050] Accordingly, it is possible to provide a therapeutic instrument that can accurately inject bone cement into intended locations throughout every corner of a vertebral body while minimizing skin incision. In particular, safety can be improved by facilitating removal even when the bone cement filling tube is buried and fixed in the filled bone cement.
[0051]
[11] A further spatula-shaped guide on the proximal side of the vertebral body perforation guide (Figures 8 to 12) In the therapeutic instrument according to
[10] , the vertebral body perforation guide further includes a terminal end portion (14) having an opening (11-3) that opens in the same direction as the distal end portion on the distal side of the intermediate portion. The bone cement filling tube is inserted into the vertebral body perforation guide along the second central axis from the terminal end portion, and when passing through the intermediate portion along the second central axis, the injection port protrudes from the opening of the distal end portion.
[0052] Accordingly, the insertion direction of the bone cement filling tube can be guided more accurately.
[0053] 2. Details of Embodiments Embodiments will be described in further detail.
[0054] [Embodiment 1] Figure 1 is a side view showing an example of the configuration of the bone cement filling tube 3 and the push rod 38 used therewith according to the present invention, and Figures 2 and 3 are cross-sectional views thereof. In Figures 2 and 3, the tip side and the proximal side of the shaft 34 are shown in enlargement, respectively, to aid understanding. The bone cement filling tube 3 has a shaft 34 and a curved portion 33 sequentially from the distal end to the proximal end. 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 and has a tapered structure in which the outer diameter decreases from the shaft 34 to the tip.
[0055] In Figures 1 to 3, 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.
[0056] The tapered structure may be present not only in the curved portion 33 but also in the shaft 34, and may be a structure in which the outer diameter gradually decreases from the shaft 34 to the tip of the curved portion 33. For example, as shown in the inset indicated by the arrow extending from the curved portion 33 in the upper part of Figure 2, 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 the tapered structure is present in the 1 / 3 on the tip side, with the outer diameter of the tip becoming smaller. More specifically, for example, the outer diameter Φt at the tip < the outer diameter Φm of the intermediate part = the diameter Φb of the part connected to the shaft 34. On the other hand, the tapered structure may be formed not only in the entire curved portion 33 but also on the tip side of the shaft 34. The length and size (angle) of the tapered structure formed are appropriately designed according to the depth of embedding and the strength of fixation of the bone cement filling tube 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 be embedded and fixed in the bone cement, removal can be facilitated by extending the tapered structure to that portion of the shaft 34.
[0057] 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 section 33 of the bone cement filling tube 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.
[0058] The bone cement filling tube 3 may be configured to be used together with a pusher rod 38, as illustrated in Figures 1, 2, and 3. The pusher rod 38, also called a pusher, is cylindrical in shape that can be inserted into the hollow portion 35 of the shaft 34 of the bone cement filling tube 3, and is easier to operate if it has a handle at the distal end, as illustrated in Figures 1, 2, and 3. The bone cement is pre-filled into the hollow portion 35 (or also into the hollow portion 36) of the bone cement filling tube 3, and after the tip of the bone cement filling tube 3 is guided into the vertebral body, the pusher rod 38 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.
[0059] In the bone cement-filled tube 3 shown in Figure 2, the inner diameter of the hollow section 36 of the curved section 33 is configured to gradually decrease from the connection point with the shaft 34 towards the injection port 31. In the bone cement-filled tube 3 shown in Figure 3, the inner diameter of the hollow section 35 of the shaft 34 is constant and is larger than the inner diameter of the hollow section 36 of the curved section 33. In the bone cement-filled tubes 3 shown in Figures 2 and 3, by designing the inner diameter of the hollow section 35 of the shaft 34 to match the outer diameter of the push rod 38, the bone cement filled throughout the hollow section 35 can be pushed in by the cylindrical push rod 38 with a constant outer diameter and injected through the hollow section 36 of the curved section 33 from the injection port 31, thus minimizing the amount of bone cement remaining in the tube without being injected. The bone cement-filled tube 3 shown in Figure 2 can employ a simple manufacturing method, such as narrowing the portion that becomes the curved section 33 from a single cylinder, which can relatively reduce manufacturing costs. In the bone cement-filled tube 3 shown in Figure 3, increasing the thickness of the curved portion 33 reduces the risk of the curved portion 33 breaking.
[0060] The shaft 34 and curved portion 33 of the bone cement filling tube 3 are made of stainless steel, for example, and the shaft 34 is preferably straight. The push rod 38 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 38. The shaft 34 can be curved and the push rod 38 can be made flexible, but a straight shape can accommodate bone cement with higher viscosity.
[0061] Instead of the push rod 38, the bone cement may be injected under pressure from the injection port 39 using a syringe or the like. Figure 4 is a cross-sectional view showing an example of the configuration of the bone cement filling tube 3 and a syringe 60 used with it according to the present invention. As with Figures 2 and 3, Figure 4 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 tube 3, and the bone cement filled in the syringe 60 is injected into the bone cement filling tube 3 from the injection port 39 by applying pressure with the plunger 61, and then ejected from the ejection port 31 and injected 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 tube 3, or a Luer lock type syringe 60 may be attached to the injection port 39 of the cement filling tube 3. Furthermore, if the viscosity of the bone cement is high and the hollow sections 35 and 36 of the bone cement filling tube 3 are narrow, a syringe 60 with a screw-type plunger 61 can be used. Since the bone cement is injected by the rotational force of the plunger 61, the force required for injection is reduced, making it more practical. Moreover, the instrument to be attached is not limited to a syringe 60. Any instrument that can inject bone cement under pressure from the injection port 39 of the bone cement filling tube 3 will suffice. Since the bone cement is injected under pressure from the injection port 39, the hollow section 35 of the shaft 34 of the bone cement filling tube 3 can have a narrow diameter similar to the hollow section 36 of the curved section 33.
[0062] The bone cement filling tube 3 has a curved portion 33 that curves 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, the curve may make it difficult to remove. If a portion of the bone cement filling tube 3, including its 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. In such cases, if the bone cement filling tube 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 tube 3 becomes embedded and fixed in the bone cement, applying a force to rotate the shaft 34 around its central axis will not allow it to rotate, or even if it can rotate, the curved portion 33 will rotate along with the embedded bone cement. The curved portion 33 of the bone cement filling tube 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.
[0063] As described above, the bone cement filling tube 3 of the present invention can be easily removed from the filled bone cement in percutaneous vertebroplasty for fractures or in surgeries to reinforce the vertebral body with bone cement.
[0064] In the bone cement-filled tube 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 allows for a larger amount of bone cement to be filled into the shaft 34 than if the entire hollow portion (35 and 36) were made of the same diameter.
[0065] The bone cement filling tube 3 may also be equipped with a handle 32 at the distal end of the shaft 34. This facilitates various operations of the bone cement filling tube 3, including removal. In Figures 1 to 3, the direction of the handle 32 is shown as vertical, the same as the direction of curvature of the curved portion 33, but it can be any direction, for example, horizontal (from the front to the back of the page).
[0066] The bone cement filling tube 3 of the present invention is further preferably provided with a connecting portion 37 on its distal end to which a slap hammer 70 can be connected. Figure 5 is a side view (middle) and a cross-sectional view (bottom) showing an example configuration of the bone cement filling tube 3 (top) and a slap hammer 70 used therewith. The slap hammer 70 comprises a hammer shaft 71 (generally simply called a "shaft," but referred to as a "hammer shaft" in this specification to clearly distinguish it from the shaft 34 of the bone cement filling tube 3), a sliding portion 72, a grip 73, and an impact portion 74. The sliding portion 72 is a heavy cylindrical object 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 portion 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, a heavy metal such as stainless steel is selected as the material for the sliding part 72 in order to apply a large impact force. However, to make it easy to grip and less slippery, the gripping part may be covered with plastic resin.
[0067] Preferably, the impact portion 74 at the tip of the slap hammer 70 is configured to be connectable to the connecting portion 37 of the bone cement filling tube 3 of the present invention. The connection mechanism is arbitrary; for example, the connecting 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 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 connecting 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.
[0068] This makes it possible to remove the bone cement filling tube 3 even if the tip of the bone cement filling tube 3 becomes embedded in the bone cement filling the vertebral body and hardens and becomes fixed in place.
[0069] As mentioned above, even when the handle 32, the connecting part 37, or both are attached to the distal end of the shaft 34, they must be attached in a way that does not block the inlet 39. The handle 32 and the connecting part 37 may be made of plastic, for example, instead of metalwork such as welding, with a through hole in the center that matches the outer diameter of the shaft 34, and attached to the distal end of the shaft 34 by adhesive or insert molding.
[0070] [Embodiment 2] A second embodiment of the bone cement filling tube 3 of the present invention will be described. Figures 6 and 7 are cross-sectional views showing an example of the configuration of the bone cement filling tube 3 of this second embodiment, which includes a bone cement filling section and a bone cement pressing section. Similar to Figures 2 and 3, the tip and proximal ends of the shaft 34 are shown in enlarged view to aid understanding.
[0071] The bone cement filling tube 3 is provided with a bone cement filling section 65 on the distal side of the shaft 34, and further comprises a bone cement pushing section 66. More specifically, the hollow section 35 of the shaft 34 consists of a conduit 64 on the proximal side that communicates with the hollow section 36 of the curved section 33, and a bone cement filling section 65 on the distal side that is thicker (has a larger inner diameter) than the conduit 64. The distal end of the shaft 34, that is, the distal end of the bone cement filling section 65, is a bone cement injection port 39. The bone cement pushing section 66 is inserted into the hollow section of the bone cement filling section 65 and is configured to push the bone cement filled in the hollow section from this injection port 39 into the hollow section 36 of the curved section 33.
[0072] This allows a large volume of bone cement to be filled into the bone cement filling tube 3. The proximal side of the shaft 34 connected to the curved portion 33 may be a conduit 64 with a narrow inner diameter of the hollow portion as described above, or the entire hollow portion 35 of the shaft 34 may be used as the bone cement filling portion 65. In the above-described embodiment 1, the form described with reference to Figure 3 can be positioned as one aspect thereof. When bone cement is injected, bone cement may be pre-filled not only in the bone cement filling portion 65, but also in the hollow portion 35 of the shaft 34 and the hollow portion 36 of the curved portion.
[0073] The bone cement filling tube 3 illustrated in Figure 7 has threads formed on the outer circumference of the bone cement inlet 66 and on the inner wall of the hollow portion 35 of the shaft 34 that constitutes the bone cement filling tube 65, which are mutually interlocking. After filling the bone cement filling tube 65 with bone cement, the bone cement inlet 66 is screwed in from the distal end along the threads, allowing the filled bone cement to be pushed out from the nozzle 31 even if the viscosity of the bone cement is high, or if the hollow portion 36 of the conduit 64 or curved portion 33 is narrow and requires a large force to press. Although not shown in the figure, the threads in the bone cement filling tube 65 may be limited to the distal or intermediate part of the bone cement filling tube 65.
[0074] In this second embodiment, the bone cement filling tube 3 is more preferably equipped with a handle 32 and a connection portion 37 for the slap hammer 70 at the distal end of the shaft 34, that is, at the distal end of the bone cement filling portion 65, as illustrated in Figures 6 and 7. The details are the same as in the first embodiment, so redundant explanations will be omitted. In this second embodiment, the outer diameter of the bone cement filling portion 65 is larger than in the example of the first embodiment, so the connection mechanism provided at the connection portion 37 and the impact portion 74 of the slap hammer 70 is also designed to be larger accordingly.
[0075] [Embodiment 3] The bone cement filling tube 3 of the present invention is more preferably used in combination with the vertebral body drilling guide 1 and the bone drilling instrument 2.
[0076] Figure 8 is an explanatory diagram showing a perspective view of one configuration example of the treatment device 100 of the present invention, including the bone cement filling tube 3. As illustrated in Figure 8, the treatment device 100 may be composed of an inner needle 4 and a balloon catheter 5 in addition to the vertebral body drilling guide 1, the bone drilling instrument 2, and the bone cement filling tube 3. In Embodiment 1, the central axis of the bone cement filling tube 3, which was simply called the "central axis," will be renamed the first central axis, and in Embodiment 2, the central axis of the vertebral body drilling guide 1 will be called the "second central axis." When inserting the bone cement filling tube 3 into the vertebral body drilling guide 1 for use, the first central axis and the second central axis are generally aligned, but it is not necessary to align them strictly on the same straight line, hence the different names are merely used. When there is no need to particularly distinguish between the generally aligned first central axis and the second central axis, they may be simply referred to as the "central axis" below.
[0077] The vertebral body perforation guide 1 is a hollow cylindrical shape aligned with the second central axis, and has a tip portion 12 that opens downward (-z direction) perpendicular to the second central axis at the tip end, an intermediate portion 13 that opens in the opposite direction (+z direction) at the distal end, and a terminal portion 14 that opens in the same direction as the tip portion 12 (-z direction).
[0078] The bone drilling instrument 2 has a straight shaft and a curved section, similar to the bone cement filling tube 3, and the tip of the curved section has a bone drilling section 21 with a sharp structure for drilling bone. The curved section is curved downward (-z direction) along the central axis and is inserted from the terminal section 14 of the vertebral body drilling guide 1 along the second central axis. When it passes through the intermediate section 13 along the second central axis, the bone drilling section 21 protrudes from the opening 11-1 of the tip section 12. Although not shown in the figures, the shaft of the bone drilling instrument 2 may have a shape that facilitates insertion into the vertebral body drilling guide 1 and may be curved with a gentle curvature. Also, the bone drilling section 21 may not have a sharp structure, but may have a blunt structure that can crush the cancellous bone within the vertebral body.
[0079] The bone cement filling tube 3 is also configured such that when it is inserted into the intermediate portion 13 of the vertebral body perforation guide 1 along the second central axis, its tip portion protrudes from the opening 11-1 of its tip portion 12.
[0080] The vertebral body perforation guide 1 may be configured without the distal portion 14. Furthermore, as illustrated in Figure 8, if a support portion 15 is provided at the distal portion of the vertebral body perforation guide 1 (at the distal portion of the distal portion 14 if one exists), and an inverted U-shaped opening is provided that opens in the same direction as the distal portion 14, the guidance can be made even more reliable by allowing other instruments, including the bone cement filling tube 3, to pass through the inverted U-shaped opening. In addition, as illustrated in Figure 8, a gripping portion 16 extending in the opposite direction to the support portion 15 may be provided at the distal portion of the vertebral body perforation guide 1.
[0081] Thus, by using the treatment device 100, which comprises a vertebral body drilling guide 1, a bone drilling instrument 2, and a bone cement filling tube 3, bone cement can be accurately injected into every corner of the vertebral body at the intended location while minimizing skin incisions. In particular, safety can be enhanced by making it easy to remove the bone cement filling tube even if it becomes embedded and fixed in the filled bone cement.
[0082] As described above, the vertebral body drilling guide 1 may be configured without the terminal portion 14, but it is more preferable to provide the terminal portion 14. The terminal portion 14 has an opening 11-3 in the same direction as the tip portion 12, located on the root side (distal side) of the intermediate portion 13. The bone cement filling tube 3 is inserted into the vertebral body drilling guide 1 from the opening 11-3 of the terminal portion 14 along the second central axis, passes through the intermediate portion 13 along the second central axis, and is configured to have an ejection port 31 protruding from the opening 11-1 of the tip portion 12. This allows for more accurate guidance of the insertion direction of the bone cement filling tube 3. This is because the bone cement filling tube 3 passes through two points: the connection point between the tip portion 12 and the intermediate portion 13, and the connection point between the intermediate portion 13 and the terminal portion 14, so the path to insertion into the vertebral body is defined along the vertebral body drilling guide 1.
[0083] Furthermore, the opening 11-2 in the intermediate section 13 is not necessarily required, and may be widened upwards (in the opposite direction from the opening of the tip section 12, in the +z direction) to allow other instruments, including the bone cement filling tube 3, to pass through the intermediate section 13. Also, the opening 11-3 in the terminal section 14 does not need to be formed over the entire terminal section 14, and may be limited to a specific area considering the passage of other instruments, including the bone cement filling tube 3.
[0084] Figures 9 and 10 are schematic diagrams illustrating the procedure for using the treatment device 100 of the present invention, which comprises a bone drilling device 2, a bone cement filling tube 3, and a vertebral body drilling guide 1. The procedure involves using the bone drilling device 2 to excavate inside the vertebral body to form a cavity, and then guiding the bone cement filling tube 3 into the vertebral body 90. The diagram schematically represents a view of the affected vertebral body 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. The diagram shows the state after the skin 99 has been incised from the dorsal side and the vertebral body drilling guide 1 has been inserted into the vertebral body 90 through the pedicle 91.
[0085] The inserted vertebral body perforation guide 1 has its intermediate portion 13 and distal portion 14 connected at the incision 98 where the skin 99 has been cut, the distal portion 14 which has a support portion 15 and a gripping portion 16 at its distal end is on the outside of the skin 99, the intermediate portion 13 is inside the body, the connection point between the intermediate portion 13 and the tip portion 12 is located near the entrance of the bone hole formed in the pedicle 91, and the tip portion 12 reaches into the vertebral body 90.
[0086] Figure 9 is a schematic diagram illustrating the procedure for guiding the bone drilling instrument 2 into the vertebral body 90 using the vertebral body drilling guide 1 to excavate and form a cavity.
[0087] [1] shows the bone drilling instrument 2 inserted from its tip into the middle section 13 through the opening of the terminal section 14 of the vertebral body drilling guide 1, with the bone drilling section 21 entering the pedicle 91. At this time, the instrument is operated so that the curved section and shaft of the bone drilling instrument 2 always pass through the connection point between the middle section 13 and the terminal section 14. The curved section passes slightly beyond the opening of the middle section 13, but since this area is made of soft muscle, it can be inserted without resistance, and because the curved section curves smoothly inward, the risk of the tip damaging the muscle is extremely low.
[0088] [2] shows the state after [1], where the bone drilling portion 21 at the tip of the bone drilling instrument 2 has been inserted into the vertebral body 90 from the pedicle 91 through the connection point between the middle portion 13 and the tip portion 12. Even in this state, the bone drilling instrument 2 has passed through the connection point between the middle portion 13 and the distal portion 14. After this, in the process of deepening the insertion of the bone drilling instrument 2, the instrument 2 is operated in such a way that it always passes through the two points: the connection point between the middle portion 13 and the tip portion 12 and the connection point between the middle portion 13 and the distal portion 14.
[0089] [3] shows the bone drilling portion 21 at the tip of the bone drilling instrument 2 reaching deep into the vertebral body 90. In the example in Figure 9, the bone drilling portion 21 has reached near the lower endplate 92b, allowing for excavation of a wide area within the vertebral body 90.
[0090] Figure 10 is a schematic diagram illustrating the procedure for guiding a bone cement filling tube 3 into the vertebral body 90 using the same vertebral body drilling guide 1 after a cavity has been formed within the vertebral body 90 using a bone drilling instrument 2.
[0091] [4] shows the bone cement filling tube 3 inserted from its tip into the middle section 13 through the opening of the terminal section 14 of the vertebral body perforation guide 1, with the curved section 33 inserted into the body. During this operation, as in [1] above, the curved section 33 and shaft 34 of the bone cement filling tube 3 are operated so that they always pass through the connection point between the middle section 13 and the terminal section 14. The curved section 33 passes slightly beyond the opening of the middle section 13, but since this area is soft muscle, it can be inserted without resistance, and because the curved section 33 curves smoothly inward, the risk of the tip damaging the muscle is extremely low.
[0092] [5] is the state after [4], in which the tip of the curved portion 33 has been inserted into the vertebral body 90 from the pedicle 91 through the connection point between the intermediate portion 13 and the tip portion 12. Even in this state, the shaft 34 of the bone cement filling tube 3 has passed through the connection point between the intermediate portion 13 and the terminal portion 14. After this, in the process of deepening the insertion of the bone cement filling tube 3, the bone cement filling tube 3 is operated in the same way as in [2] above, so that it always passes through the two points: the connection point between the intermediate portion 13 and the tip portion 12 and the connection point between the intermediate portion 13 and the terminal portion 14.
[0093] [6] shows the state in which the curved portion 33 of the bone cement filling tube 3 has reached deep into the vertebral body 90. In the example of Figure 10, the exit port 31 has reached close to the lower endplate 92b, and bone cement can be filled close to the lower endplate 92b as well.
[0094] By using the bone cement filling tube 3 of the present invention, bone cement can be accurately injected into every corner of the vertebral body 90 at the intended location by appropriately adjusting the size and length of the curvature. Multiple types of bone cement filling tubes 3 with different curvature sizes and lengths may be prepared in advance and used accordingly. Furthermore, by inserting the tube using the vertebral body perforation guide 1, the bone cement filling tube 3 is operated so that it always passes through two points: the connection point between the tip 12 and the middle section 13, and the connection point between the middle section 13 and the terminal section 14. As a result, the incision in the skin 99 only needs to be about the size of the vertebral body perforation guide 1 plus a little extra, thus achieving a minimally invasive procedure with extremely little burden on the patient.
[0095] [Embodiment 4] The treatment device 100 of the present invention preferably comprises, as illustrated in Figure 8, an inner needle 4 and a balloon catheter 5 in addition to the vertebral body perforation guide 1, the bone perforation device 2 and the bone cement filling tube 3. The inner needle 4 and the balloon catheter 5 are basically linear and are inserted distally along the central axis of the vertebral body perforation guide 1 (corresponding to the "second central axis" in Embodiment 3, but to avoid complexity, will be simply referred to as the "central axis" hereafter) and protrude from the tip of the tip portion 12. This makes it possible to provide a set of treatment devices necessary for percutaneous vertebroplasty.
[0096] 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 at the tip 12, middle 13, and terminal 14 of the vertebral body drilling guide 1, but is introduced into the vertebral body simply by passing along the central axis. The tip of the inner needle 4 is provided with a bone drilling portion 41 with a sharp structure. In addition, a screw thread (not shown) may be formed on the outer circumference of the bone drilling portion 41 to assist in tapping. It is preferable that a grip 42 is provided at the distal end of the inner needle 4. The grip 42 may further include 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. By becoming one, the operability in operations such as processing bone holes in the pedicle can be improved. Furthermore, the central axis of the inner needle 4 may be provided with a through hole 49 through which a guide pin can be passed.
[0097] 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 tip portion 12.
[0098] [Procedure] Figures 11 and 12 are explanatory diagrams showing the main steps of the surgical procedure using the treatment device 100 of the present invention. Similar to Figures 9 and 10, 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. Note that for bone drilling instruments, reference numeral 2 is a general term, and reference numerals 2-1 and 2-2 are used for bone drilling instruments with different curvatures. Similarly, for bone cement filling tubes, reference numeral 3 is a general term, and reference numerals 3-0 (straight), 3-1, and 3-2 are used for bone drilling instruments with different curvatures.
[0099] 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 separate, straight, hollow drilling instrument may be inserted into the vertebral body 90 through the pedicle 91, and a guide pin may be placed in the bone hole of the pedicle 91 formed by the straight drilling instrument. Then, using the placed guide pin as a guide, the vertebral body drilling guide 1 and inner needle 4 may be inserted and their tips introduced into the vertebral body 90. Alternatively, the guide pin may be inserted directly first, and the integrated vertebral body drilling 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 drilling 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.
[0100] Step [2]: Figure 11 [2] shows the vertebral body drilling guide 1 and inner needle 4 inserted into the vertebral body 90 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 point between the tip 12 and the middle part 13 of the vertebral body drilling guide 1 is located near the boundary between the pedicle 91 and the vertebral body 90, and the connection point between the middle part 13 and the terminal part 14 is located near the opening 98. The inner needle 4 is then removed from this state.
[0101] Step [3]: Insert the balloon catheter 5 through the vertebral body perforation guide 1. In Figure 11, the balloon catheter 5 is simplified, and the balloon inflator, which should be 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.
[0102] 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, the bone can be excavated and the cavity expanded to the anterior inferior corner of the vertebral body 90, where the balloon 51 could not form a cavity.
[0103] Step [5] (see Figure 12 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 can be drilled to the lower endplate 92b and a position close to the dorsal side of the vertebral body 90, which could not be reached even with the less curved bone drilling instrument 2-1.
[0104] Step [6]: Insert a bone cement filling tube 3-0, which is straight or has very little curvature, into the vertebral body 90 through the vertebral body perforation guide 1 and fill the formed cavity with bone cement 97.
[0105] Step [7]: Insert a bone cement filling tube 3-1 with a small curve 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.
[0106] Step [8]: Insert the highly curved bone cement filling tube 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.
[0107] 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 tube 3-2 with a greater curvature in step [8] may be used first for filling, or bone cement filling instruments 3-0 to 3-2 with different degrees of curvature may be appropriately selected and used alternately without a set order, depending on the degree of bone cement filling. This makes it possible to fill the bone cement in the intended location.
[0108] 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.
[0109] [Embodiment 5] Figure 13 is an explanatory diagram showing the procedure for separating the bone cement filling tube 3 from the bone cement using a slap hammer 70 when the bone cement filling tube 3 has become fixed to the bone cement. Similar to Figures 9 to 12, 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.
[0110] Step [9]: After the procedure of injecting bone cement into the vertebral body 90 using the bone cement filling tube 3 in steps [6] to [8] of Figure 12, the bone cement hardens before the bone cement filling tube 3 is removed, and the tip of the bone cement filling tube 3 embedded in the bone cement becomes fixed.
[0111] Step
[10] : After connecting the impact part 74 of the slap hammer 70 to the connection part 37 at the distal end of the bone cement filling tube 3, the sliding part 72 is slid along the hammer shaft 71 between the grip 73 and the impact part 74, causing the sliding part 72 to collide with the grip 73 once or repeatedly. The impact force generated by this collision is transmitted to the tip of the bone cement filling tube 3, and this impact force releases the bone cement filling tube 3 from being fixed to the bone cement.
[0112] Step
[11] : Remove the bone cement filling tube 3. Since it is freed from adhesion to the bone cement, it can be easily removed. It may be removed with the slap hammer 70 still attached, or the slap hammer 70 may be removed first, and then only the bone cement filling tube 3 may be removed.
[0113] Step
[12] : Remove the bone drilling guide 1, suture the opening 98, and close the wound to complete the procedure.
[0114] Needless to say, if the bone cement filling tube 3 can be removed before the bone cement hardens and the tip of the bone cement filling tube 3 adheres to the filled bone cement, step
[10] may be omitted.
[0115] The present inventors have described the invention in detail above based on embodiments, but it goes without saying that the present invention is not limited thereto and can be modified in various ways without departing from its essence. For example, the vertebral body drilling guide 1 may have no opening in the intermediate portion 13. As described in embodiments 2 and 3, if an opening is provided in the intermediate portion 13, when a curved vertebral body processing instrument (for example, a bone drilling instrument 2 or a bone cement filling tube 3) is passed through, the curved portion protrudes outward from the opening 11-2 of the intermediate portion 13 and 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 and passes through. However, it cannot be said that there is absolutely no risk that the passing instrument may get caught on the muscles and even injure them. In order to solve this problem, the vertebral body drilling guide 1 may be modified so that there is no opening in the intermediate portion 13.
[0116] 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.
[0117] 1. Vertebral body drilling guide 2, 2-1, 2-2. Bone drilling instrument 3, 3-0, 3-1, 3-2. Bone cement filling tube 4. Inner needle 5. Balloon catheter 11-1, 11-2, 11-3. Opening 12. Tip 13. Middle 14. Terminal 15. Support 16. Gripping part 21, 41. Bone drilling part 22, 42. Grip 31. Outlet 32. Handle 33. Curved part 34. Shaft 35, 36. Hollow part 37, 57. Connection part 38. Push rod 39. Injection port 49. Through hole 51. Balloon 52. Balloon inflator 60. Syringe 61. Plunger 64. Conduit 65. Bone cement filling part 66. Bone cement pushing part 70. Slap hammer 71. Hammer shaft 72. Sliding part 73 Grip 74 Impact part 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 bone cement filling tube having a shaft and a curved portion sequentially from the distal end to the proximal end, the shaft having a bone cement injection port at the distal end, the curved portion having a bone cement injection port at the proximal end, the shaft and the curved portion having a hollow portion communicating from the injection port to the injection port, the curved portion curving away from the central axis of the shaft at its tip and having a tapered structure in which the outer diameter decreases from the distal end to the proximal end.
2. The bone cement filling tube according to claim 1, wherein the diameter of the hollow portion of the curved portion gradually decreases toward the injection port.
3. The bone cement filling tube according to claim 1, wherein the diameter of the hollow portion of the shaft is greater than the diameter of the hollow portion of the curved portion.
4. The bone cement filling tube according to claim 1, further comprising a handle at the distal end of the shaft.
5. The tapered structure in claim 1 is a bone cement-filled tube extending proximal to the shaft.
6. The bone cement filling tube according to claim 1, wherein the shaft further comprises a connecting portion distal to which a slap hammer can be connected.
7. The bone cement filling tube according to claim 1, wherein the bone cement filling tube further comprises a bone cement injector, the shaft comprises a bone cement filling tube distal to the shaft, and the bone cement injector is inserted into the hollow portion of the bone cement filling tube and pushes the bone cement filled in the hollow portion from the injection port into the hollow portion of the curved portion.
8. The bone cement filling tube according to claim 7, wherein the outer circumference of the bone cement pressing portion and the inner wall of the hollow portion of the shaft constituting the bone cement filling portion have threads that screw together with each other.
9. The bone cement filling tube according to claim 7, wherein the shaft further comprises a connecting portion on the distal side of the bone cement filling portion to which a slap hammer can be connected.
10. A therapeutic device comprising a bone cement filling tube according to any one of claims 1 to 9 and a vertebral body drilling guide, wherein the central axis of the shaft is a first central axis, the vertebral body drilling guide is a hollow cylindrical shape along a second central axis and has a tip portion that opens perpendicular to the central axis at the tip end along the second central axis and a middle portion at the distal end along the second central axis, and the bone cement filling tube protrudes from the opening of the tip portion when inserted into the vertebral body drilling guide from the middle portion along the second central axis.
11. The treatment device according to claim 10, wherein the vertebral body perforation guide further has a terminal portion distal to the intermediate portion having an opening that opens in the same direction as the tip portion, and the bone cement filling tube is inserted into the vertebral body perforation guide from the terminal portion along the second central axis, and when it passes through the intermediate portion along the second central axis, the ejection port protrudes from the opening of the tip portion.