Puncture device for creating hole in vertebra and inserting pedicle screw for fixation

Abstract

To enable a surgeon to safely insert a puncture needle into a pedicle when creating a hole for inserting a PPS screw into a vertebra.SOLUTION: A puncture needle is inserted into a cylindrical shaft and housed therein, and both are removably connected, with a tip of the needle protruding from an opening at a tip of the cylindrical shaft. A distal end of the cylindrical shaft is reduced in outer diameter by a longitudinal distance equivalent to the length of a PPS screw to form a puncture part, and when the puncture needle, with its tip protruding from the opening of the puncture part, is struck from above with a hammer to insert it into a vertebra, a step is formed in the cylindrical shaft. The step prevents the tip of the puncture needle from penetrating beyond the longitudinal length of the puncture part into the interior of the vertebra from the cortical bone, the starting point of puncture.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a puncture device for forming a drill hole in a vertebra and inserting and fixing a pedicle screw therein. [Background technology]

[0002] Posterior spinal fusion is a surgical procedure used to treat spinal disorders of the lumbar and thoracic spine. After removing part of the vertebral arch to relieve pressure on the nerves, some intervertebral discs are removed and a filler called a cage is inserted to maintain the stability of the spine, and the vertebrae are then fixed with screws and rods.

[0003] Until now, posterior spinal fixation has typically been performed by opening the patient's back and inserting pedicle screws into the exposed vertebral pedicles. However, extensive detachment of the patient's lower back muscles can cause significant damage to the patient and delay recovery, so minimally invasive spinal surgery is now being used.

[0004] The percutaneous pedicle screw (PPS) system is used as a minimally invasive spinal surgery method. In the PPS system, a puncture needle is inserted through a small port opened in the patient's back to create a hole in the pedicle, a guidewire is inserted into the hole, and a cannulated pedicle screw is passed through the guidewire inserted into the hole to insert and fix the screw percutaneously into the pedicle. Next, the heads of the multiple screws inserted and fixed in the pedicle are connected with a rod to fix them in place. [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] Thoracolumbar posterior fixation using percutaneous pedicle screws - Comparison with conventional methods - Spine Surgery Vol. 23 No. 1 April 2009 Masahiro Kawanishi et al.

[0006] [Non-patent document 2] Investigation of insertion accuracy in the early stage of percutaneous pedicle screw introduction Orthopedics and Trauma Surgery 65(3)545-547, 2016 Seigo Densho et al.

[0007] With the PPS system, the patient's back is not opened and exposed, so the surgeon uses a puncture needle to insert the screw into the pedicle under fluoroscopic guidance using a C-arm (X-ray fluoroscopy device). After making a small incision in the muscle of the patient's lower back, the surgeon strikes the probe with a hammer to create an insertion point on the outer edge of the pedicle and then inserts the needle. Once it is confirmed that the tip of the needle has reached the inner edge of the pedicle, the inserted needle is withdrawn and replaced with a guide wire. By passing the guide wire inserted into the drill hole through the through-hole of the cannulated pedicle screw, the screw can be accurately inserted into the drill hole in the pedicle.

[0008] When using a puncture needle under C-arm fluoroscopy, the needle is inserted to the appropriate depth while observing the shadow on the inner wall of the pedicle under frontal fluoroscopy, and the needle is then inserted further after confirming the insertion depth under lateral fluoroscopy (see Figure 3). However, since the depth cannot be visually confirmed during insertion in this frontal view, there is a risk of damaging blood vessels that extend beyond the anterior wall and exist in front of the vertebral body. Under these circumstances, a new device and method that is easy to handle and allows the surgeon to safely insert the puncture needle into the pedicle was needed. Summary of the Invention [Means for solving the problem]

[0009] After extensive research to solve the above problems, the inventors of the present invention came up with the idea of ​​inserting and housing a puncture needle into a cylindrical shaft, and then removably connecting the two with the tip of the needle protruding from an opening at the tip of the cylindrical shaft. The distal end of the cylindrical shaft is formed as a puncture section by narrowing its outer diameter by a longitudinal distance corresponding to the length of the pedicle screw, and the puncture needle, with its tip protruding from the opening at the puncture section, can be inserted into a vertebra by striking it from above with a hammer. A step is formed in the cylindrical shaft due to the difference in outer diameter from the puncture section, and the step prevents the tip of the puncture needle from penetrating beyond the cortical bone at the starting point of puncture and into the interior of the vertebra beyond the longitudinal length of the puncture section.

[0010] Based on the above idea, the inventor of the present invention provides a puncture device for forming a drill hole in a vertebra and inserting and fixing a pedicle screw, the device comprising: the puncture device includes a cylindrical shaft and a puncture needle housed in and connected to and fixed within the cylindrical shaft; the cylindrical shaft has a collar portion formed at a proximal end, a sleeve portion extending a predetermined distance in a distal direction from the collar portion, and a puncture portion extending a further predetermined distance from the distal end of the sleeve portion; An internal thread is formed on the cylindrical inner circumferential wall of the collar portion, the sleeve portion has a longitudinal length and an inner diameter that accommodate the puncture needle within a cylinder, the puncture portion has the same inner diameter as the sleeve portion, but an outer diameter smaller than the outer diameter of the sleeve portion, forming a step between the puncture portion and the sleeve portion; The puncture needle has a handle portion, a support portion formed continuously with a lower portion of the handle portion, and a stylus extending distally from the support portion, the handle portion has a head portion formed so that an operator can strike the tip of the puncture needle with a hammer to drive the tip into a vertebra; an outer peripheral wall of the support portion is formed with an outer thread that can be fitted with an inner thread formed on an inner peripheral wall of the collar portion; the stylus has a length that allows the puncture needle to be inserted into the cylindrical shaft and accommodated therein, and the tip of the stylus protrudes from an opening at the tip of the puncture part; When the puncture needle is housed within the cylinder of the cylindrical shaft and the internal thread of the collar portion and the external thread of the connection portion are engaged and tightened, the tip of the stylus protrudes from the tip opening of the puncture portion while the puncture needle is connected and fixed to the cylindrical shaft, forming a protrusion; The longitudinal length of the puncture portion is formed to be equal to or shorter than the length of the screw portion of the pedicle screw, and when the head of the handle portion is struck with a hammer to drive the tip of the stylus protruding from the opening of the puncture portion into the vertebra to open a drill hole, the step formed between the puncture portion and the sleeve prevents the tip of the puncture portion from penetrating into the vertebra beyond the length of the screw portion. The inventors have now arrived at the invention of a puncture device for drilling holes in the vertebrae and inserting and fixing pedicle screws.

[0011] The inventors of the present invention further provide a set of devices for drilling holes in vertebrae and inserting and fixing pedicle screws, comprising: The set includes a cylindrical shaft, a puncture needle housed in the cylindrical shaft and fixedly connected to it, a guide wire, and a cannulated pedicle screw; the cylindrical shaft has a collar portion formed at a proximal end thereof, a sleeve portion extending a predetermined distance in a distal direction from the collar portion, and a puncture portion extending a further predetermined distance from the distal end of the sleeve portion, the puncture portion being formed so as to have an outer diameter reduced by a longitudinal distance corresponding to the length of the screw portion of the cannulated pedicle screw, thereby forming a step between the puncture portion and the sleeve portion; the puncture needle has a handle portion, a support portion formed continuously with the handle portion, and a stylus extending distally from the support portion, the tip of the stylus being formed so as to protrude from an opening at the tip of the puncture portion when the puncture needle is inserted into the cylindrical shaft; the guide wire has an outer diameter and a length that allows it to be inserted into the cylindrical shaft; the cannulated pedicle screw has a through-hole through which the guide wire can be inserted; The puncture needle is accommodated in the cylindrical shaft, and an internal thread formed on the inner wall of the collar portion is engaged with an external thread formed on the outer periphery of the connecting portion and tightened, so that, with the puncture needle connected and fixed to the cylindrical shaft, the tip of the stylus protrudes from the tip opening of the puncture portion to form a protrusion; When the head of the handle portion of the puncture needle is struck with a hammer to drive the puncture portion with the tip of the stylus protruding into the vertebra to open a perforation, the step formed between the puncture portion and the sleeve prevents the tip of the puncture portion from penetrating into the vertebra beyond the length of the screw portion. The inventors have arrived at the invention of a set of devices for drilling holes in the vertebrae and inserting and fixing pedicle screws into the vertebrae.

[0012] Preferably, the tip of the stylus protrudes from the opening of the puncture part by 2 to 4 mm(?).

[0013] Preferably, the collar portion has an outer diameter and an inner diameter both larger than those of the sleeve portion, and the outer diameter of the support portion of the puncture needle is set to a size that allows the shaft of the puncture needle to be fixed when the puncture needle is inserted into the cylindrical shaft by fitting the support portion into the cylinder of the collar portion of the cylindrical shaft.

[0014] Preferably, the outer diameter of the puncture portion is smaller than the outer diameter of the pedicle screw that is inserted into the vertebra.

[0015] Preferably, the stylus of the puncture needle has a diameter similar to that of a guide wire used to pass through the cannula of the pedicle screw and guide the screw into the drill hole.

[0016] Preferably, the puncture needles are prepared in two types: one with a stylus tip formed into a sharp needle tip, and the other with a hemispherical tip with a specified radius. After forming an insertion point in the cortical bone with the stylus with the sharp needle tip, a perforation is formed in the cancellous bone with the stylus with the hemispherical tip with the specified radius.

[0017] Preferably, the length of the puncture portion of the cylindrical shaft is approximately equal to the longitudinal length of the screw portion of the pedicle screw that is inserted into the vertebra.

[0018] Preferably, the piercing device is made of steel. [Effects of the Invention]

[0019] In one embodiment of the puncture device of the present invention, the outer diameter of the distal end of the cylindrical shaft is narrowed to form the puncture section, so that the tip of the stylus of the puncture needle protruding from the opening of the puncture section can be struck from above with a hammer, allowing the puncture needle housed in the puncture section of the cylindrical shaft to be inserted into a vertebra.

[0020] In one embodiment of the puncture device of the present invention, the longitudinal length of the puncture portion is formed to be the same as or shorter than the length of the screw portion of the pedicle screw to be inserted into the vertebra, so that when the head of the handle portion of the puncture needle is struck with a hammer to drive the puncture portion with the protruding tip of the stylus into the vertebra to open a perforation, the step formed between the puncture portion and the sleeve portion prevents the tip of the puncture portion from penetrating into the vertebra beyond the length of the screw portion.

[0021] In one embodiment of the puncture device of the present invention, the puncture needle is removably and replaceably connected and fixed to the cylindrical shaft, so that a needle with a sharp tip is used when driving into hard cortical bone, and a needle with a safer rounded tip is used instead of the sharp needle when driving into soft cancellous bone, thereby avoiding the risk of the sharp tip damaging the tissue inside the vertebra.

[0022] In one embodiment of the puncture device of the present invention, the outer diameter of the stylus of the puncture needle is the same as the outer diameter of the guide wire, so that the puncture needle can be removed from the cylindrical shaft, replaced with a guide wire, and passed through the cylindrical shaft, thereby inserting and piercing the guide wire into a perforation formed in a vertebra.

[0023] In one embodiment of the puncture device of the present invention, after the puncture needle is inserted into the vertebra, the puncture needle is removed from the cylindrical shaft and replaced with a guide wire, and then the cylindrical shaft is removed with the guide wire still inserted into the vertebra, and the through hole of the cannulated pedicle screw can then be passed through the guide wire left in the vertebra. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 shows a perspective view of one embodiment of the puncture device of the present invention. [Figure 2(A)] FIG. 2(A) shows the cylindrical shaft of one embodiment of the puncture device of the present invention. [Figure 2(B)] FIG. 2(B) shows a puncture needle (having a sharp tip) of one embodiment of the puncture device of the present invention. [Figure 2(C)] FIG. 2(C) shows a puncture needle (having a hemispherical tip) of one embodiment of the puncture device of the present invention. [Figure 3] FIG. 3 shows a PC screen display of the state in which the puncture device of the present invention is being inserted into a vertebra using a C-arm (X-ray fluoroscopic diagnostic device). [Figure 4] FIG. 4 shows how the surgeon uses a hammer to drive the puncture device of the present invention into a vertebra. [Figure 5] FIG. 5 shows a method for replacing the puncture needle of the puncture device of the present invention from one with a sharp tip to one with a blunt tip. [Figure 6] Figure 6(A) shows a method of inserting a guide wire into a hole drilled in a vertebra using the puncture device of the present invention, and Figure 6(B) shows a method of passing a cannulated pedicle screw through a guide wire that has been punctured into a hole drilled in a vertebra using the puncture device of the present invention. [Figure 7] FIG. 7 shows a puncture device of the present invention and a set of guidewires and cannulated pedicle screws for use therewith. DETAILED DESCRIPTION OF THE INVENTION

[0025] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

[0026] Fig. 1 shows a perspective view of a puncture device of the present invention. Fig. 2(A) shows a cylindrical shaft of one embodiment of a puncture device of the present invention, Fig. 2(B) shows a puncture needle of one embodiment of a puncture device of the present invention (the tip of the stylus is formed sharply), and Fig. 2(C) shows a puncture needle of one embodiment of a puncture device of the present invention (the tip of the stylus is formed hemispherically).

[0027] 1 and 2, in the puncture device 100 of the present invention, the puncture needle 10 is inserted into and housed in a cylindrical shaft 20, with the tip of the needle protruding from the opening at the tip of the cylindrical shaft 20. An internal thread is cut into the inner wall of the collar portion 21 of the cylindrical shaft 20, and by engaging and tightening with an external thread cut into the outer periphery of the support portion 12 of the puncture needle 10, the puncture needle 10 and the cylindrical shaft 20 are firmly connected and fixed. In one embodiment of the present invention, the longitudinal length of the puncture needle is set to 165 mm, and the longitudinal length of the cylindrical shaft is set to 122 mm. The tip of the stylus 13 protrudes 3 mm(?) from the opening of the puncture portion 23.

[0028] The inner and outer diameters of the collar portion 21 of the cylindrical shaft 20 are formed larger than the inner and outer diameters of the sleeve portion 22, and the outer diameter of the support portion 12 of the puncture needle 10 is set to a size that allows the collar portion 21 and support portion 12 of the cylindrical shaft 20 to fit together when the puncture needle 10 is inserted into the cylindrical shaft 20, thereby fixing the axis of the stylus 13 of the puncture needle 10. The outer periphery of the collar portion 21 is formed in a hexagonal shape so that the surgeon can easily tighten / loosen the screw by grasping the puncture needle 10 and the cylindrical shaft 20 with both hands and rotating them relative to each other.

[0029] The distal end of the cylindrical shaft 20 is formed with an outer diameter smaller than that of the sleeve portion 22, and the portion formed with the smaller outer diameter constitutes the puncture portion 23. In one embodiment of the present invention, the outer diameter of the puncture portion 23 is set to 3 mm, and the outer diameter of the sleeve portion is set to 6 mm.

[0030] When the puncture needle 10 is inserted into the cylindrical shaft 20 and the outer and inner threads are engaged and rotated relative to each other to tighten the screw, the stylus 13 of the puncture needle 10 advances through the puncture portion 23 of the cylindrical shaft 20 and protrudes approximately 3 mm from the opening 24. The tip of the stylus 13 is sharp, and when the tip of the stylus 13 is placed against the insertion position of the vertebra and the puncture needle is struck with a hammer to apply an impact (see Figure 4), the hard cortical bone of the vertebra is crushed by the sharp tip of the stylus 13, forming an insertion point.

[0031] The surgeon inserts the tip of the needle into the vertebra starting from the insertion point created in the vertebra, and while using C-arm fluoroscopy, can adjust the angle at which the needle penetrates into the vertebra (see Figure 3). Initially, a sharp-tipped stylus is used for the puncture needle 10. However, after the needle passes through the cortical bone, the cancellous bone becomes soft, so a sharp tip is not necessary. In fact, a sharp tip poses the risk of damaging the tissue inside the patient's vertebra. Therefore, after first creating the insertion point with the sharp-tipped stylus 13, the puncture needle 10 is removed from the cylindrical shaft 20 and replaced with a puncture needle 10' with a round-tipped stylus 13'. Subsequently, the puncture needle 10' with the round-tipped stylus 13' can be used to create a perforation in the vertebra (see Figure 5).

[0032] FIG. 6(A) shows a method of inserting the puncture device 100 of the present invention into a vertebra, and then removing the puncture needle 10 from the cylindrical shaft 20 and inserting the guide wire 30. FIG. 6(B) shows a method of inserting a guide wire 30 into a vertebra using the puncture device 100 of the present invention, and then passing a cannulated pedicle screw 40 through the guide wire 30.

[0033] FIG. 7 shows a set of the puncture device 100, guide wire 30 and cannulated pedicle screw 40 of the present invention.

[0034] Although the embodiments of the present invention have been described above with reference to the drawings, the present invention is not limited to these embodiments and can be modified and implemented in various embodiments within the scope of the present invention. Explanation of symbols

[0035] 100 Lancing Device 10, 10' puncture needle 11, 11' Handle 12, 12' support part 13, 13' sleeve section 20 Cylindrical shaft 21 Color Section 22 Sleeve section 23 Puncture site 24 Opening 30 Guidewire 40 pedicle screws

Claims

1. A puncture device for forming a drill hole in a vertebra and inserting and fixing a pedicle screw, comprising: the puncture device includes a cylindrical shaft and a puncture needle housed in and connected to and fixed within the cylindrical shaft; the cylindrical shaft has a collar portion formed at a proximal end, a sleeve portion extending a predetermined distance in a distal direction from the collar portion, and a puncture portion extending a further predetermined distance from the distal end of the sleeve portion; An internal thread is formed on the cylindrical inner circumferential wall of the collar portion, the sleeve portion has a longitudinal length and an inner diameter that accommodate the puncture needle within a cylinder, the puncture portion has the same inner diameter as the sleeve portion, but an outer diameter smaller than the outer diameter of the sleeve portion, forming a step between the puncture portion and the sleeve portion; The puncture needle has a handle portion, a support portion formed continuously with a lower portion of the handle portion, and a stylus extending distally from the support portion, the handle portion has a head portion formed so that an operator can strike the tip of the puncture needle with a hammer to drive the tip into a vertebra; an outer peripheral wall of the support portion is formed with an outer thread that can be fitted with an inner thread formed on an inner peripheral wall of the collar portion; the stylus has a length that allows the puncture needle to be inserted into the cylindrical shaft and accommodated therein, and the tip of the stylus protrudes from an opening at the tip of the puncture part; When the puncture needle is housed within the cylinder of the cylindrical shaft and the internal thread of the collar portion and the external thread of the connection portion are engaged and tightened, the tip of the stylus protrudes from the tip opening of the puncture portion while the puncture needle is connected and fixed to the cylindrical shaft, forming a protrusion; The longitudinal length of the puncture portion is formed to be equal to or shorter than the length of the screw portion of the pedicle screw, and when the head of the handle portion is struck with a hammer to drive the tip of the stylus protruding from the opening of the puncture portion into the vertebra to open a drill hole, the step formed between the puncture portion and the sleeve prevents the tip of the puncture portion from penetrating into the vertebra beyond the length of the screw portion. A puncture device for drilling holes in the vertebrae and inserting and fixing pedicle screws.

2. The device of claim 1, wherein the tip of the stylus protrudes 2-4 mm(?) from the opening of the puncture portion.

3. The device described in claim 1 or 2, wherein the collar portion has an outer diameter and an inner diameter both larger than those of the sleeve portion, and the outer diameter of the support portion is set to a size such that when the puncture needle is inserted into the cylindrical shaft, the support portion fits into the cylinder of the collar portion of the cylindrical shaft, thereby fixing the axis of the puncture needle.

4. The device according to claim 1 or 2, wherein the outer diameter of the puncture portion is smaller than the outer diameter of the screw of the pedicle screw.

5. 3. The device according to claim 1 or 2, wherein the stylus of the puncture needle has a diameter equivalent to that of a guide wire used to pass through the cannula of the pedicle screw and guide the screw into the drill hole.

6. The device according to claim 1 or 2, wherein the tip of the stylus of the puncture needle is formed into a sharp needle tip.

7. The device according to claim 1 or 2, wherein the tip of the stylus of the puncture needle is formed in a hemispherical shape having a predetermined R.

8. 3. The device of claim 1 or 2, wherein the length of the puncture is about 30 mm.

9. The device according to claim 1 or 2, wherein the length of the penetrating portion of the cylindrical shaft is approximately equal to the longitudinal length of the screw portion of the pedicle screw that is inserted into the vertebra.

10. A set of devices for forming drill holes in vertebrae and inserting and fixing pedicle screws, comprising: The set includes a cylindrical shaft, a puncture needle housed in the cylindrical shaft and fixedly connected to it, a guide wire, and a cannulated pedicle screw; the cylindrical shaft has a collar portion formed at a proximal end thereof, a sleeve portion extending a predetermined distance in a distal direction from the collar portion, and a puncture portion extending a further predetermined distance from the distal end of the sleeve portion, the puncture portion being formed so as to have an outer diameter reduced by a longitudinal distance corresponding to the length of the screw portion of the cannulated pedicle screw, thereby forming a step between the puncture portion and the sleeve portion; the puncture needle has a handle portion, a support portion formed continuously with the handle portion, and a stylus extending distally from the support portion, the tip of the stylus being formed so as to protrude from an opening at the tip of the puncture portion when the puncture needle is inserted into the cylindrical shaft; the guide wire has an outer diameter and a length that allows it to be inserted into the cylindrical shaft; the cannulated pedicle screw has a through-hole through which the guide wire can be inserted; The puncture needle is accommodated in the cylindrical shaft, and an internal thread formed on the inner wall of the collar portion is engaged with an external thread formed on the outer periphery of the connecting portion and tightened, so that, with the puncture needle connected and fixed to the cylindrical shaft, the tip of the stylus protrudes from the tip opening of the puncture portion to form a protrusion; When the head of the handle portion of the puncture needle is struck with a hammer to drive the puncture portion with the tip of the stylus protruding into the vertebra to open a perforation, the step formed between the puncture portion and the sleeve prevents the tip of the puncture portion from penetrating into the vertebra beyond the length of the screw portion. A set of devices for drilling holes in the vertebrae and inserting and fixing pedicle screws into the vertebrae.

11. The device described in claim 10, wherein the puncture needle includes two types of stylus: one with a sharp tip and one with a hemispherical shape with a predetermined radius, and is configured to form an insertion point in the cortical bone with the sharp tip stylus, and then form a perforation in the cancellous bone with the hemispherical shape with the predetermined radius.

Images