Treatment instrument

Abstract

Provided is a treatment instrument comprising a trial cage, a bone drilling needle, and a bone cement filling tube, wherein the trial cage has a head part that has a prescribed thickness, width, and length, and a support rod that supports the head part at an end part thereof in the length direction of the head part. The head part has flat surfaces that determine the prescribed thickness and at least one guide hole. The guide hole passes through the head part in the thickness direction, from a distal side of the head part to one of the flat surfaces, and the respective tip end parts of the bone drilling needle and the bone cement filling tube can pass therethrough. Thus, it is possible to provide a treatment instrument that is used in a treatment prior to inserting an artificial intervertebral disc into an intervertebral disc cavity, and that makes it possible to create bone holes in the upper and lower vertebrae which will sandwich the artificial intervertebral disc, perform filling with bone cement through those holes while the same apparatus is still inserted, and thereby reinforce, from the inside, the upper and lower vertebrae sandwiching a cage.

Description

treatment equipment

[0001] The present invention relates to a spinal and cervical spine treatment device for inserting an intervertebral body spinal implant (artificial disc) into an intervertebral disc space, and is particularly suitable for use in surgery in which the device is inserted between vertebrae (also called "vertebral bodies") to ensure a gap (intervertebral disc space) for the insertion of an artificial disc before the insertion.

[0002] One spinal treatment involves implanting a specialized artificial disc material (sometimes called a "cage," but hereafter referred to as an "artificial disc") between adjacent vertebral bodies (intervertebral disc space). Under healthy conditions, adjacent vertebral bodies form a joint by sandwiching an intervertebral disc via thin cartilage called endplates. However, when diseases that damage the intervertebral disc become severe, the application of an artificial disc implantation procedure is considered. In this procedure, an artificial disc is inserted into the gap (intervertebral disc space) created by removing the damaged disc. The inserted artificial disc fuses with the vertebral body, achieving intervertebral fixation. To determine the appropriate size of the artificial disc to be inserted, a trial cage (sometimes simply called a "trial" or "cage trial," but hereafter referred to as a "trial cage") is used. Various sizes of trial cages are available, and the appropriate size is determined by inserting them into the intervertebral space.

[0003] Currently, there is a growing demand for spinal fusion surgery among the elderly in Japan. Spinal fusion surgery is a treatment method in which a specialized artificial disc is inserted into a narrowed intervertebral space (disc space) and filled with autologous and artificial bone tissue to fuse the two vertebrae sandwiching the artificial disc. The artificial disc restores the narrowed intervertebral space to its normal height, and bone fusion is achieved while maintaining that height, resulting in relief of symptoms such as neuralgia and lower back pain.

[0004] Patent Document 1 discloses a trial consisting of a shaft and an end portion attached to the tip thereof and inserted into the intervertebral space. The shaft is hollow and has a passageway and an outlet extending from the tip to the outside of the end portion. Various bone growth promoting substances such as bone morphogenetic proteins, bone graft tissue, bone powder, and bone cement can be introduced into the affected area through the shaft and from the outlet at the end portion, and also allows tools such as extrusion devices, impact devices, and delivery tubes to access the affected area (paragraph 0009, etc.).

[0005] Patent Document 2 discloses an endplate perforator that can form a bone hole that is approximately perpendicular to the endplate. The device is configured so that a needle member can be protruded approximately perpendicularly into the vertebral body from an operating unit case that is inserted into the gap between the vertebral bodies, and is said to be able to safely and easily promote intervertebral bone fusion.

[0006] JP 2018-69067 A JP 2022-52575 A

[0007] The inventors of the present invention have noticed that, due to the prevalence of osteoporosis among elderly patients, conventional artificial disc implantation procedures pose a risk of the artificial disc embedding into the endplates of the vertebrae above and below the artificial disc (resulting in fractures of the endplate bones and resulting in subsidence of the artificial disc). This makes it difficult to maintain the narrowed intervertebral space at its normal height until bone fusion. This not only results in no improvement in symptoms, but also leads to the need for major reoperation due to loosening of the implant, among other reasons. The inventors therefore developed a technology that can reinforce the vertebrae above and below the artificial disc with bone cement, thereby maintaining the size of the intervertebral space without subsiding into the vertebrae. The term "upper and lower" here refers to the patient standing with their spine approximately perpendicular to the floor (unless otherwise specified). The term "upper and lower" does not refer to the patient's posture during surgery.

[0008] The trial cage shown in Patent Document 1 maintains the reinforcement and size of the intervertebral disc space by allowing the introduction of bone growth promoting substances while the trial cage is inserted. It is also stated that instruments such as a pusher, impactor, and delivery tube can be passed through the trial cage (paragraph 0009). However, such instruments merely reinforce the intervertebral disc space, which "may be desirable when bone quality has deteriorated and / or there is a void to be filled and the surgeon wishes to densify the bone of the vertebral body and / or fill the void with graft material to provide a harder surface for the intervertebral body spinal implant to seat" (paragraph 0016).

[0009] The endplate drill disclosed in Patent Document 2 is safe and easy to use because it can be protruded roughly perpendicular to the vertebral body, but a mechanical structure that changes the direction of force transmission is provided inside the working unit case so that it can also be protruded perpendicular to the shaft, making it possible to drill holes in the upper and lower vertebrae that make up the intervertebral disc space. However, no consideration is given to the introduction of bone cement or bone growth promoting substances through the bone hole created while the same instrument is inserted.

[0010] The object of the present invention is to provide a treatment device that can be used for treatment prior to inserting an artificial disc into the intervertebral disc space. This device creates bone holes in the vertebrae above and below that sandwich the artificial disc, and fills bone cement through the holes while the same device is still inserted, thereby reinforcing the vertebrae above and below that sandwich the artificial disc from the inside.

[0011] The means for solving these problems will be described below, but other problems and novel features will become apparent from the description of this specification and the accompanying drawings.

[0012] According to one embodiment of the present invention, the following is true.

[0013] That is, the treatment instrument includes a trial cage, a bone drilling needle, and a bone cement filling tube, wherein the trial cage has a head having a predetermined thickness, width, and length, and support rods supporting the head at its longitudinal ends. The head has a flat surface that determines the predetermined thickness, and at least one guide hole that penetrates the head in the thickness direction from the distal side of the head toward one of the flat surfaces, and is configured to allow the respective tips of the bone drilling needle and the bone cement filling tube to pass through.

[0014] The effects obtained by the embodiment are briefly described below.

[0015] In other words, a treatment device can be provided that is used for treatment prior to inserting an artificial disc into the intervertebral disc space. This device creates bone holes in the vertebrae above and below that sandwich the artificial disc, and fills bone cement through the holes while the same device is still inserted, thereby reinforcing the upper and lower vertebrae that sandwich the artificial disc from the inside.

[0016] FIG. 1 is an explanatory diagram showing an example of the configuration of a treatment instrument according to a first embodiment of the present invention. FIG. 2 is an enlarged view showing the distal end of a trial cage according to the present invention. FIG. 3 is an explanatory diagram showing an example of the configuration of the distal end of a trial cage according to the present invention. FIG. 4 is an explanatory diagram showing a perspective view of the function of the distal end of a trial cage according to the present invention. FIG. 5 is an explanatory diagram showing an example of the configuration of a treatment instrument according to a second embodiment of the present invention. FIG. 6 is an explanatory diagram showing a perspective view of the function of the distal end of a trial cage according to the second embodiment. FIG. 7A is an explanatory diagram showing the first step (retraction) of an example of surgery using the treatment instrument according to the present invention. FIG. 7B is an explanatory diagram showing the second step (disc removal) of an example of surgery using the treatment instrument according to the present invention. FIG. 7C is an explanatory diagram showing the third step (trial cage insertion) of an example of surgery using the treatment instrument according to the present invention. FIG. 7D is an explanatory diagram showing the fourth step (drilling) of an example of surgery using the treatment instrument according to the present invention. FIG. 7E is an explanatory diagram showing the fifth step (bone cement filling) of an example of surgery using the treatment instrument according to the present invention. FIG. 7F is an explanatory diagram showing the sixth step (trial cage removal) of an example of surgery using the treatment instrument according to the present invention. Fig. 7G is an explanatory diagram showing the seventh step (insertion of an artificial intervertebral disc) of an example of surgery using the treatment instrument of the present invention. Fig. 7H is an explanatory diagram showing the eighth step (suturing the wound) of an example of surgery using the treatment instrument of the present invention. Fig. 8 is an explanatory diagram showing an example of the configuration of a treatment instrument according to a third embodiment of the present invention. Fig. 9 is an explanatory diagram showing an example of the configuration of a trial cage of a treatment instrument according to a fourth embodiment of the present invention.

[0017] 1. Overview of the Embodiments First, an overview of the representative embodiments disclosed in the present application will be described. Reference numerals in parentheses in the drawings used in the overview of the representative embodiments merely illustrate components included in the concept of the components to which they are attached.

[0018] [1] Trial cage to assist injection of bone cement into vertebral body (Figs. 1 to 4) A representative embodiment disclosed in the present application is a treatment instrument (100) including a trial cage (1), a bone drilling needle (2), and a bone cement filling tube (3), and is configured as follows: Here, the bone cement filling tube (3) is a tube pre-filled with bone cement, and is an instrument that can apply pressure from the distal end to release the filled bone cement from an opening at the proximal end and fill the affected area.

[0019] The trial cage has a head (11) having a predetermined thickness, width and length, and support rods (12) that support the head at the ends in the length direction of the head.

[0020] The head portion has a flat surface that determines the predetermined thickness and at least one guide hole (13-1).

[0021] The guide hole penetrates the thickness of the head from the distal side of the head toward one of the flat surfaces, and allows the tip ends of the bone drilling needle and the bone cement filling tube to pass through.

[0022] This makes it possible to provide a treatment device that can be used in a procedure prior to inserting an artificial disc into the intervertebral disc space.The device creates bone holes in the vertebrae above and below that sandwich the artificial disc, and fills bone cement through the holes while the same device is still inserted, thereby reinforcing the vertebrae above and below that sandwich the cage.

[0023] [2] Addition of a vertebral body excavator and a balloon catheter (Fig. 8) The treatment device of [1] further comprises at least one of a vertebral body excavator (4) and a balloon catheter (5).

[0024] The vertebral body excavator has a tube (41) and a drilling end (40) at the proximal end of the tube that extends in the extension direction of the tube, can be bent from the extension direction, and is configured to be able to pass through the guide hole while extending in the extension direction of the tube.

[0025] The balloon catheter has a tube (51), a balloon (50) at the proximal end of the tube, and a balloon inflator (52) at the distal end that can inflate the balloon, and is configured so that the balloon can pass through the guide hole in a deflated state.

[0026] This allows the vertebral body to be restored to a more appropriate size and reinforced even if the vertebral body adjacent to the intervertebral disc cavity into which the artificial disc is to be implanted is damaged due to a compression fracture or the like during surgery to implant the artificial disc. For example, this can be used in conjunction with surgery to reconstruct the vertebral body, or as a replacement.

[0027] [3] Multiple guide holes (Figs. 1 to 2) In the treatment instrument of [1] or [2], the head has multiple guide holes including another guide hole (13-2) that penetrates from the other surface to the one surface.

[0028] This allows the tip of the bone drill needle (2), bone cement filling tube (3), vertebral excavator (4) and / or balloon catheter (5) to protrude from both sides of the trial cage (1).

[0029] [4] Curved toward the vertebral body (Fig. 3) In the treatment instrument of [1], [2] or [3], the guide hole (13-2) of the trial cage has an entrance (14-2) on the side closer to the support rod and an exit (15-2) on the far side, and when an instrument other than the trial cage is inserted, the entrance angle (θ i ) than the protruding angle of the outlet (θ o ) is curved so that the angle of approach (θ i ) and protrusion angle (θ o ) is defined as follows, for example: i ) is the angle at the entrance of the central axis of the device based on the central axis of the support rod (12), and the protrusion angle (θ o ) is the angle at the exit of the central axis of the instrument relative to the central axis of the support rod (12).

[0030] This allows the directions of the bone drilling needle (2), bone cement filling tube (3), vertebral body excavator (4) and / or balloon catheter (5) protruding from the trial cage (1) to be directed toward the center of the vertebral body, thereby making it possible to more appropriately fill the bone cement at the appropriate location.

[0031] [5] Stopper to prevent excessive protrusion (Figs. 5 and 6) In any one of the treatment instruments [1] to [4], the bone drilling needle (2) is provided with a stopper (21) that abuts against one surface when a predetermined length protrudes from the other surface, preventing further protrusion.

[0032] This prevents the bone drilling needle (2) from accidentally protruding excessively even when the vertebral bone is fragile.

[0033] [6] The guide hole and the support rod are in communication (Fig. 9). In the trial cage of the treatment instrument according to any one of [1] to [5], the support rod is hollow and in communication with the guide hole.

[0034] This allows bleeding near the head of the trial cage to be drained from the surgical field through the guide hole and the hollow inside the support rod (through hole 17), ensuring a clear field of view.

[0035] 2. Details of the embodiment The embodiment will be described in further detail.

[0036] [Embodiment 1] Fig. 1 is an explanatory diagram showing an example of the configuration of a treatment instrument 100 of the present invention. Fig. 2 is an enlarged view showing the tip of a trial cage 1, Fig. 3 is an explanatory diagram showing the configuration, and Fig. 4 is an explanatory diagram showing a perspective view of the function of the tip. The upper part of Fig. 2 shows a top view, and the lower part shows a side view. In the side view, guide holes 13-1 and 13-2 are shown with dashed lines, but they cannot be seen from the actual side.

[0037] The treatment instrument 100 comprises a trial cage 1 , a bone drilling needle 2 , and a bone cement filling tube 3 .

[0038] The bone drilling needle 2 is an instrument with a sharp tip (proximal end) like a drill bit, and can drill a bone hole in a vertebral bone by striking the distal end with a hammer or the like. If the needle can be rotated, the tip (proximal end) can be shaped like a drill rather than a drill bit, and a hole can be formed by rotation.

[0039] The bone cement filling tube 3 is a tube that can be filled with bone cement in advance, and by applying pressure from the distal end, the filled bone cement can be released from an opening at the proximal end and injected into the affected area. To enable pressure to be applied from the distal end, the distal end has a structure similar to that of a syringe, for example, and by inserting the tip (proximal end) into the created bone hole, bone cement can be delivered into the vertebra.

[0040] The trial cage 1 includes a head 11 having a predetermined thickness, width, and length, and a support rod 12 supporting the head 11 at its end. The head 11 has a flat surface that determines the predetermined thickness and at least one guide hole 13-2. The guide hole 13-2 penetrates from one side (the upper side in FIGS. 3 and 4 ) of the flat surface of the head 11 to the other side (the lower side in FIGS. 3 and 4 ) and has a diameter that allows the respective tips of the bone drilling needle 2 and the bone cement filling tube 3 to pass through. As illustrated in FIGS. 1 to 4 , the entrance 14-2 of the guide hole 13-2 is preferably formed not only on the flat surface of the head 11 but also on a surface slightly tilted distally, and penetrates from the distal side to one of the flat surfaces of the head in the thickness direction of the head. Note that in this specification, even when the guide hole penetrates not only from a flat surface but also from a slightly tilted surface to the other side, it may be simply expressed as penetrating from the upper surface to the lower surface or from the lower surface to the upper surface. FIG. 3 illustrates a bone drilling needle 2, but the same applies to a bone cement filling tube 3, a vertebral body excavator 4 and a balloon catheter 5 of a third embodiment described later.

[0041] This makes it possible to provide a treatment device that can be used in a procedure prior to inserting an artificial disc into the intervertebral disc space. This device creates bone holes in the vertebrae above and below that sandwich the artificial disc, and fills bone cement through the holes while the same device is still inserted, thereby reinforcing the upper and lower vertebrae that sandwich the artificial disc from the inside.

[0042] The thickness, width, and length of the head 11 of the trial cage 1 correspond to the thickness, width, and length of the artificial intervertebral disc to be inserted into the intervertebral disc space. The head 11 is provided in various sizes in appropriate increments, for example, with a thickness of 6 to 14 mm, a width of 14 to 24 mm, and a length of 45 to 65 mm, and is inserted to measure the size of the patient's intervertebral disc space in order to determine the appropriate size of the artificial intervertebral disc to be implanted. The head 11 may be made of, for example, stainless steel or aluminum alloy.

[0043] The head 11 of the trial cage 1 preferably has multiple guide holes. For example, as shown in FIGS. 2 and 3 , in addition to the guide holes 13-2 that penetrate from the top surface to the bottom surface, two guide holes 13-1 that penetrate from the bottom surface to the top surface are provided in the left-right direction (the up-down direction in the top view of FIG. 2 ). Here, the guide holes are referred to collectively using the reference numeral 13, and when distinguished, they are distinguished by adding subnumbers such as 13-1 and 13-2. The inlets and outlets are also referred to collectively as 14 and 15, and subnumbers are added to distinguish them according to their arrangement. The guide holes 13-2 that penetrate from the top surface to the bottom surface are provided in total, one on each side of the axis of the support rod 11, and enter through inlets 14-2-1 and 14-2-2 on the top surface of the head 11 and penetrate through outlets 15-2-1 and 15-2-2 on the bottom surface of the head 11. Although the bottom view is omitted in Figure 2, outlet 15-2-1 is located on the opposite side of outlet 15-1-1 in the top view, and outlet 15-2-2 is located on the opposite side of outlet 15-1-2 in the top view. Similarly, guide holes 13-1 penetrating from the bottom surface to the top surface are provided in total of two, one on each side of the axis of the support rod 11, and enter from inlets 14-1-1 and 14-1-2 in the bottom surface of the head 11 and penetrate to outlets 15-1-1 and 15-1-2 in the bottom surface of the head 11. Although the bottom view is omitted in Figure 2, inlets 14-1-1 and 14-1-2 are located on the opposite side of inlets 14-2-1 and 14-2-2 in the top view, respectively. Depending on the diameter and arrangement of the guide holes, the inlets 14-2-1 and 14-2-2, and the inlets 14-1-1 and 14-1-2 may partially overlap, as illustrated in the upper part of Figure 2. Multiple guide holes may also intersect inside the head 11 of the trial cage 1. The inlets 14 of the guide holes 13 are preferably chamfered. This allows for smoother guide of the bone drilling needle 2 and the bone cement filling tube 3 when they are inserted. The bone cement filling tube 3 is also preferably thinner than the bone drilling needle 2. When inserted into the bone hole formed by the bone drilling needle 2, it is smoothly inserted without hitting the corners of the bone hole.

[0044] The bone drilling needle 2, the bone cement filling tube 3, and the guide holes 13-1 and 13-2 are preferably curved in the same manner so that the tip of the bone drilling needle 2 and the bone cement filling tube 3 can pass through the guide holes 13-1 and 13-2. As shown in Figure 3, the direction of the curve is determined by the angle of entry (θ i ) than the protruding angle of the outlet (θ o The guide hole 13-2 and the bone drilling needle 2 are curved so that the angle of approach (θ i ) and protrusion angle (θ o ) is defined, for example, by the angle of the central axis of the bone drilling needle 2 at the inlet and outlet relative to the central axis of the support rod 12, with the central axis of the support rod 12 as the reference. Although the bone drilling needle 2 has been used as an example, the same applies to the bone cement filling tube 3 and other instruments described later.

[0045] This allows the directions of the bone drilling needle 2 and bone cement filling tube 3 protruding from the trial cage 1 to be directed toward the center of the adjacent vertebral body, making it possible to more appropriately fill the bone cement at the appropriate location.

[0046] However, the bone drilling needle 2, the bone cement filling tube 3, and the guide holes 13-1 and 13-2 may be straight instead of curved. Even if the guide holes 13-1 and 13-2 are curved and the bone drilling needle 2 and the bone cement filling tube 3 are straight, by making their diameters smaller than the diameters of the guide holes 13-1 and 13-2, their tips can be guided to the inside of the adjacent vertebral bodies.

[0047] 2 and other figures show an example in which the head 11 of the trial cage 1 is provided with two guide holes penetrating from the top to the bottom and two guide holes penetrating from the bottom to the top, but a configuration in which one guide hole is provided for each is also suitable. This is because the two guide holes can be positioned so that they do not intersect inside the head 11 of the trial cage 1. By configuring the guide holes so that they do not overlap, the risk of instruments or the like getting caught at the intersection can be eliminated.

[0048] Furthermore, the head 11 of the trial cage 1 may be configured to have only one guide hole penetrating from one surface to the other. By using only one guide hole, bone cement is filled into either the upper or lower vertebral body per insertion of the trial cage 1, but the trial cage 1 can be inserted once for each of the upper and lower vertebral body preparations. Although the number of insertions increases, using one guide hole allows the head 11 of the trial cage 1 to be positioned along the central axis, making it easier to drill a bone hole roughly in the center of the vertebral body.

[0049] [Example of surgery using the treatment device of the present invention] Figures 7A to 7H are explanatory diagrams showing the procedure of an example of surgery using the treatment device of the present invention. Figures 7A to 7H show steps 1 to 8. The figures are drawn assuming a surgery in which the patient lies down, an incision is made from the flank to the affected area, and an artificial intervertebral disc is implanted. The left and right in the figures correspond to the up and down from the patient's perspective, but directions are expressed according to the illustration.

[0050] First step (FIG. 7A): The patient's flank is incised to reach the affected area, and a retractor 90 is inserted into the incision 98 to open it and ensure a clear view. Second step (FIG. 7B): The knob 91 is inserted into the affected intervertebral disc 96-x to separate the damaged disc 96-x from the vertebral body 95-3. Although not shown, another knob 91 is inserted on the opposite side of the vertebral body 95-2 to separate and remove the disc 96-x. Third step (FIG. 7C): The head 11 of the trial cage 1 is inserted into the disc space created by removing the affected intervertebral disc 96-x, and the size of the artificial intervertebral disc 30 to be finally implanted is determined. At this time, the head 11 of the trial cage 1 is inserted forcefully to slightly expand the disc space vertically. Fourth step (FIG. 7D): The bone drilling needle 2 is inserted through the guide hole in the head 11 of the trial cage 1, and the tail of the needle is struck with a hammer to drill a hole in the vertebral body 95-3, forming a bone hole. Although not shown, the bone drilling needle 2 is also inserted on the opposite side, drilling a hole in the vertebral body 95-2. Fifth step (FIG. 7E): The bone cement filling tube 3 is inserted through the guide hole in the head 11 of the trial cage 1, and bone cement 31 is injected to fill the bone hole in the vertebral body 95-3 formed in the third step. Although not shown, the bone cement filling tube 3 is also inserted through the guide hole in the head 11 of the trial cage 1, and bone cement 31 is injected to fill the bone hole in the vertebral body 95-2 on the opposite side. Fifth step (FIG. 7F): The trial cage 1 is withdrawn. Sixth step (FIG. 7G): The artificial intervertebral disc 30 is inserted into the intervertebral disc space. Seventh step (FIG. 7H): The retractor 90 is removed, and the incision is sutured. This completes the procedure for implanting the artificial intervertebral disc 30 into the spine.

[0051] In this way, vertebral bodies can be drilled in both the left and right directions (up and down on the patient) and bone cement can be injected into them while the trial cage 1 is still inserted. According to the trial in Patent Document 1, various bone growth-promoting substances, such as bone cement, can be introduced into the affected area from the tip, promoting fusion with the implanted artificial intervertebral disc. However, since the vertebral bodies are not strengthened from the inside, patients with osteoporosis may be concerned about the artificial disc sinking into the vertebrae and future compression fractures of the vertebrae above and below. In contrast, according to the surgical example shown in Figure 7, bone cement is filled into the vertebral bodies on both sides of the implanted artificial intervertebral disc 30, reinforcing the vertebrae and significantly reducing the risk of future artificial disc sinking into the vertebrae and compression fractures. Furthermore, drilling and injecting bone cement into both the left and right directions (up and down on the patient) while the trial cage 1 is still inserted not only shortens the surgical time, but also allows the bone cement to be injected using the same guide hole, allowing the bone cement filling tube 3 in the fifth step to be accurately guided into the bone hole created in the fourth step.

[0052] [Embodiment 2] Fig. 5 is an explanatory diagram showing an example of the configuration of a treatment instrument 200 according to a second embodiment of the present invention, and Fig. 6 is an explanatory perspective view showing the function of the distal end of a trial cage 1 constituting the treatment instrument. The trial cage 1 and the bone cement filling tube 3 may be the same as the trial cage 1 and the bone cement filling tube 3 of the treatment instrument 100 of Embodiment 1 shown in Figs. 1 to 4. The bone drilling needle 2 is provided with a stopper 21. When the bone drilling needle 2 is inserted into one of the guide holes 13 and protrudes from the outlet 15 of that guide hole 13 to a predetermined length, the stopper 21 abuts against the head 11 of the trial cage 1, for example, at the entrance 14, thereby stopping the insertion so that the bone drilling needle 2 does not protrude further.

[0053] This makes it possible to prevent accidents such as excessive protrusion of the bone drilling needle 2 even when the vertebral bone is fragile.

[0054] In this embodiment 2, an example is shown in which the stopper 21 is attached to the bone drilling needle 2, but the stopper may also be attached to the cement filling tube 31 or other instruments (vertebral excavator 4 and / or balloon catheter 5) described later.

[0055] [Embodiment 3] Figure 8 is an explanatory diagram showing an example of the configuration of a treatment instrument 300 according to a third embodiment. A vertebral body excavator 4 and a balloon catheter 5 are added to the treatment instrument 100 according to the first embodiment. The vertebral body excavator 4 and the balloon catheter 5 are shaped so that their distal ends can pass through the guide hole 13 in the head 11 of the trial cage 1, similar to the bone drilling needle 2. The vertebral body excavator 4 has a tube 41, a drilling tip 40 at the distal end (proximal end) of the tube 41, and a handle 42 at the proximal end (distal end). By manipulating the handle 42, the drilling tip 40 can be bent from the same direction as the distal end of the tube 41 to a direction perpendicular to the direction of the distal end. The balloon catheter 5 has a tube 51, a balloon 50 at the distal end (proximal end), and a balloon pressurizer 52 at the proximal end (distal end). The balloon 50 can be inflated by injecting, for example, a contrast medium from the balloon pressurizer 52 through the tube 51. The balloon pressurizer 52 includes, for example, a syringe for injecting a contrast medium into the balloon 50 and a pressure gauge for measuring the internal pressure of the balloon 50, but is simply illustrated as a block in FIG.

[0056] Using the treatment instrument 300, in cases of vertebral compression fractures due to osteoporosis or the like, several steps can be added to the surgical example described with reference to Figures 7A to 7H to achieve better treatment. For example, after the bone drilling shown in Figure 7D is performed, the vertebral body drilling tool 4 is inserted through the guide hole 13 of the trial cage 1, and the drilling tip 40 is guided into the vertebral body through the bone hole formed in Figure 7D to drill into the vertebral body. Next, the balloon catheter 5 is inserted through the guide hole 13 of the trial cage 1, and the balloon 50 is guided into the vertebral body through the formed bone hole. The balloon 50 is then inflated using the balloon pressurizer 52 to form a cavity within the vertebral body. Returning to the fifth step shown in Figure 7E, the bone cement filling tube 3 is inserted through the guide hole in the head 11 of the trial cage 1, and the balloon 50 is inflated to inject bone cement 31 into the formed cavity.

[0057] This allows the vertebral body to be restored to a more appropriate size and reinforced even if the vertebral body adjacent to the intervertebral disc cavity into which the artificial disc is to be implanted is damaged due to a compression fracture or the like during surgery to implant the artificial disc. For example, this can be used in conjunction with surgery to reconstruct the vertebral body, or as a replacement.

[0058] In the third embodiment, an example in which both the vertebral body excavator 4 and the balloon catheter 5 are added to the treatment instrument 300 has been shown, but only one of them may be added, or other instruments may be added, as necessary. The bone drilling needle 2 of the treatment instrument 300 may be provided with the stopper 21 shown in the second embodiment, and the other vertebral body excavator 4, balloon catheter 5, and bone cement filling tube 3 may also be provided with stoppers as appropriate.

[0059] [Embodiment 4] Figure 9 is an explanatory diagram showing an example of the configuration of a trial cage 1. In the trial cage 1, the support rod 12 is hollow, and a through hole 17 including the hollow portion of the support rod 12 is configured to communicate with the guide hole 13 of the head 11. When multiple guide holes 13 intersect, it is preferable that they communicate with the intersection point, as exemplified in Figure 9. In other words, the through hole 17 of the support rod 12 connects from the guide hole 13 at the intersection point or the like to the end of the support rod 12.

[0060] This allows bleeding near the head 11 of the trial cage 1 to be drained from the surgical field through the guide hole 13 and the hollow (through hole 17) in the support rod, ensuring a clear field of view.

[0061] For example, as shown in Figures 4, 6, and 7D, when a bone hole is formed by inserting a bone drilling needle 2 into a vertebral body through the guide hole 13 in the head 11 of the trial cage 1, blood from the bone hole may overflow into the intervertebral disc space, covering the head 11 of the trial cage 1 and making it impossible to see the entrance 14 of the guide hole 13. If this happens, when an attempt is made to insert a bone cement filling tube 3 into the guide hole 13, the entrance 14 becomes difficult to see, which hinders insertion. In response to this, as shown in Figure 9, a suction tube 60 can be attached to the distal end of the support rod 12 of the trial cage 1 to suck and discharge blood from the entrance 14 and exit 15 of the guide hole 13, thereby restoring the field of view.

[0062] 9, it is more preferable to provide a grip 16 on the support rod 12. The grip 16 should be provided at a location relatively close to the distal end of the support rod 12, leaving enough slack to allow the suction tube 60 to be attached. The suction tube 60 can be attached while the trial cage 1 is supported by grasping the grip 16.

[0063] This embodiment can be combined with any of the other embodiments.

[0064] The invention made by the inventor has been specifically described above based on an embodiment, but it goes without saying that the invention is not limited thereto and can be modified in various ways without departing from the spirit of the invention.

[0065] The present invention relates to a spinal treatment device for inserting an intervertebral body spinal implant (artificial disc) into an intervertebral disc space, and is particularly suitable for use in surgery in which the device is inserted between vertebrae to ensure a gap (intervertebral disc space) for the insertion of an artificial disc.

[0066] REFERENCE SIGNS LIST 1 Trial cage 2 Bone drilling needle 3 Bone cement filling tube 4 Vertebral body excavator 5 Balloon catheter 11 Trial cage head 12 Trial cage support rod 13 Guide hole 14 Guide hole entrance 15 Guide hole exit 16 Grip 17 Through hole 21 Stopper 30 Artificial intervertebral disc 31 Bone cement 40 Drilling end 41 Tube 42 Handle 50 Balloon 51 Tube 52 Balloon pressurizer 60 Suction tube 90 Retractor 91 Bump 95 Vertebral body 96 Intervertebral disc 97 Body surface 98 Incision 99 Suture 100, 200, 300 Treatment instrument

Claims

1. A treatment instrument including a trial cage, a bone drilling needle, and a bone cement filling tube, The trial cage has a head portion having a predetermined thickness for being inserted into an intervertebral disc space to determine the size of a gap between the end plates of the upper and lower vertebrae, and a support rod for supporting the head portion; The head portion has a flat surface that determines the predetermined thickness and at least one guide hole, The guide hole penetrates the head in the thickness direction from the distal side of the head toward one of the flat surfaces, and allows the tip ends of the bone drilling needle and the bone cement filling tube to pass through and be inserted into a vertebra. treatment equipment.

2. The treatment device of claim 1 further includes at least one of a vertebral body excavator and a balloon catheter, the vertebral body excavator has a vertebral body excavator tube and a drilling tip at a proximal end of the tube that extends in an extension direction of the tube and can be bent from the extension direction, and that is configured to be able to pass through the guide hole while extending in the extension direction of the vertebral body excavator tube; The balloon catheter has a balloon at the proximal end of the balloon catheter tube and a balloon pressurizer capable of inflating the balloon at the distal end, and the balloon is configured so that it can pass through the guide hole in a deflated state. treatment equipment.

3. In claim 1 or 2, The head has a plurality of guide holes. treatment equipment.

4. In claim 1 or 2, The bone drilling needle and the bone cement filling tube are each curved. treatment equipment.

5. In claim 4, The guide hole of the trial cage has an entrance on the side closer to the support rod and an exit on the side farther from the guide hole, and the protrusion angle of the exit is larger than the entry angle of the entrance. treatment equipment.

6. In claim 1 or 2, The bone drilling needle has a stopper that abuts against the entrance of the guide hole when the bone drilling needle protrudes a predetermined length from the one surface, thereby stopping the bone drilling needle from protruding any further. treatment equipment.

7. The trial cage according to claim 1 or 2, The support rod is hollow and communicates with the guide hole. treatment equipment.