Tool set for percutaneous extraforaminotomy and treatment method using the same

Abstract

To provide a tool set for percutaneous extraforaminotomy capable of improving straightness and directionality in a process of percutaneously passing through a muscle layer to reach a target point for resecting the transverse foraminal ligament by installing a handle on a stylet member, a trocar, a cannula and a curette comprising a tool for extraforaminotomy, and facilitating change of direction (steering) during the ligament resection process, and treatment method using the tool set for percutaneous extraforaminotomy.SOLUTION: A tool set for percutaneous extraforaminotomy comprises: a stylet member 2 including an elongated probe 12, a guide pipe 18, a cap 14 and a hub body 22; a trocar including a groove, a needle and a first handle; a canula including a sleeve, a fixed shaft and a handle; and a curette including a rod, a resection tip provided at a distal end of the rod for peeling a ligament at a resection target point, scraping up residues of a primarily resected ligament and pushing them into an intervertebral foramen, and a second handle mounted on a mounting part of the cannula.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] The present invention relates to a surgical tool set for dilating an intervertebral foramen to smoothly drain inflammatory substances from within the spinal canal to the outside of the intervertebral foramen and to inject pain-relieving medication, and a surgical method using the same. More particularly, the present invention relates to a percutaneous intervertebral foramen dilating surgical tool set and a surgical method using the same, which improves the directionality and linearity of surgical tools such as a stylet, trocar, cannula, and curette during the process of percutaneously entering the target site for ligament resection through the skin and muscle layer and then removing the ligament surrounding the intervertebral foramen, thereby enabling the target site for ligament resection to be reached in a short time, increasing maneuverability (changing direction when releasing the ligament) to facilitate the ligament resection procedure, and minimizing the gap at the connection site between the cannula and curette to increase the safety of the procedure. [Background technology]

[0002] Generally, foraminal dilation is a procedure that removes the ligaments surrounding the intervertebral foramen to open the narrowed nerve passage, and then injects pain-relieving medication to eliminate the cause of lower back and leg pain caused by nerve compression due to foraminal stenosis or spinal canal stenosis.

[0003] Currently, various papers provide detailed anatomical information about the lumbar transforaminal ligament (TFL), and many authors have performed radiological analyses of the TFL. Although authors have discussed the possible clinical implications of the ligament, the clinical implications of such a ligament remain unclear. In particular, surgeons who have focused on mechanical factors such as disc bulging, ligament thickening, and facet hypertrophy, and structural changes such as stenosis and spondylolisthesis, have not given much importance to the impact of the TFL.

[0004] On the other hand, if the size of the intervertebral foramen decreases due to stenosis or a decrease in disc height, it is quite reasonable to assume that the area occupied by the transforaminal ligament in the intervertebral foramen increases relatively. However, there is currently a lack of research and analysis into whether this is clinically significant.

[0005] An anatomical analysis of the transforaminal ligament in the lumbar intervertebral foramen (Jun-Hong Min et al., "Anatomic analysis of the transforaminal ligament in the lumbar intervertebral foramen," Operative Neurosurgery 2005, Vol. 57(1):37-41) provides an anatomical description of the lumbar transforaminal ligament. The significance of this structure is unclear, but it may contribute to relieving physical compression of the nerve root in certain cases. Spine surgeons must be aware of the existence of this structure and must consider its anatomical structure in the etiology of unexplained sciatic symptoms.

[0006] This paper is excellent and timely in its evaluation of the anatomical analysis of the transforaminal ligaments of the lumbar foramen, as the posterolateral approach is much more popular for surgically treating lumbar far-lateral discs and foraminal stenosis.

[0007] Although surgeons do not usually explore the transforaminal ligament during posterior foraminotomy in spinal treatment, it is important and useful for surgeons to have anatomical information about this area. Our study of the correlation between foraminal anatomy and procedural structures with radiological analysis of the transforaminal ligament will provide great value and information to neurosurgeons.

[0008] The clinical anatomy of the intervertebral foramen consists of the spinal nerves (dorsal root ganglia (DRG)), vertebral sinus nerves, interverbral veins, radicular veins, arteries, and ligaments (ligament flavum).

[0009] Figure 1 shows the distribution of ligaments around the intervertebral foramen. As shown, the ligaments around the intervertebral foramen are classified into entrance, intermediate, exit, and retrocanal ligaments. The entrance ligaments consist of the posterior longitudinal ligament, Hoffmann ligament, and peridural membrane. The intermediate ligaments consist of the fascial condensations that attach the nerve root sleeves to the pedicles and the ligamentum flavum. The exit ligaments (around the intervertebral foramen) consist of the internal ligament, transforaminal ligament, and external ligament. The retrocanal ligament consists of the cribriform fascia.

[0010] The role of the intervertebral foraminal ligament in inducing low back pain, including sciatica, can be divided into two aspects: inflammatory and mechanical. In the inflammatory aspect, low back pain is affected by a series of processes, including activation of small non-myelinated pain endings, release of proinflammatory cytokines, vasodilation and edema, and adhesive fibrosis. In the mechanical aspect, the following conditions must be considered: malposition of the transarticular ligaments (especially the upper and lower corporotransverse ligaments) due to acquired disc height reduction, ossification of the intervertebral foraminal ligament, nerve trunk anomalies, and dorsal root ganglion (DRG) entrapment (L5: corporotransverse ligament, L1-L4: lower corporotransverse ligament).

[0011] Chemical neurolysis is used to treat inflammatory problems, whereas mechanical epidural neurolysis via caudal catheterization or percutaneous extraforaminotomy is used to treat mechanical problems.

[0012] Back pain is a very common phenomenon that most people experience at least once in their lifetime. It is known that 70-80% of patients with back pain can be improved with conservative methods without any specific treatment. 13-40% of patients with back pain also suffer from sciatica. The pathophysiological causes of sciatica are divided into mechanical and biochemical factors. In fact, mechanical factors such as disc bulging, ligament thickening, and facet hypertrophy are often emphasized in neurosurgery for the treatment of sciatica. Most neurosurgeons have believed that mechanical problems such as disc herniation and spinal stenosis cause sciatica as well as back pain. However, the applicant's research into epidural neurolysis has confirmed that an inflammatory reaction around the intervertebral foramen is the primary cause of sciatica.

[0013] Figure 2 is a schematic diagram illustrating the process of pain and nerve dysfunction. By referring to this diagram, the process of pain and nerve dysfunction can be better understood.

[0014] As shown, step A shows the activation of adhesion molecules within the endoneurial capillaries by tumor necrosis factor (TNF).

[0015] In step B, 1) indicates adhesion of circulating white blood cells (WBCs), 2) indicates extravasation of WBCs, and 3) indicates aggregation of thrombocytes and formation of a thrombus.

[0016] In step C, 1) indicates local release of tumor necrosis factor (TNF), damage to the nerve sheath, damage to sodium channels, and allodynia within the dorsal root ganglion (DRG) and nerve spinal cord, and 2) indicates decreased blood flow and increased permeability nutritional deficit.

[0017] This suggests that biochemical factors not detected by MRI, such as insufficient blood supply to the nerves, mild inflammation, and fibroblastic adhesions around the intervertebral foramen, may play a more important role in inducing pain and abnormal nerve function.

[0018] However, to date, surgical treatment of pain in disc patients has relied on neurosurgical treatment of mechanical causes rather than analysis of biochemical factors that cannot be confirmed by MRI.

[0019] Meanwhile, a surgical tool set commonly used for intervertebral foraminal dilation or disc prolapse decompression is disclosed in U.S. Patent No. 4,573,448. As shown in Fig. 3, a conventional intervertebral foraminal dilation surgical tool comprises a sleeve 112 having a pointed, beveled end at one end and a Luer lock fitting 114 at the other end so that it can be inserted through the patient's skin and muscle layer to the target point for ligament resection around the intervertebral foramen; a probe 116 inserted into the sleeve 112 via the Luer lock fitting 114; a guide wire 118 inserted into the probe 116; and an adapter 128 having a blunt tip at one end that contacts the intervertebral foraminal ligament and a Luer lock fitting 130 at the other end, which guides the guide wire 118 and reaches the target point for ligament resection in the intervertebral foramen while being guided by it, thereby securing space for injecting an anesthetic or contrast agent. The instrument comprises a trocar 120 to be fitted; a cannula 132 which is inserted into the trocar 120 with a diameter larger than that of the trocar 120 and functions to suck out the torn ligament; and a curette 140 which is formed of a hollow circular tube so that the cannula can be inserted, and which has a grip 144 attached to one end so that a twisting motion can be applied to the proximal end of the instrument to separate the ligament closing the intervertebral foramen, and a luer lock fitting 146 attached to the other end.

[0020] The surgical tool set is configured with increasing diameters in the following order: guidewire 118, probe 116, trocar 120, curette 140, and cannula 132, which allow for local penetration to ensure sufficient dissection space at the target site of ligament resection in the intervertebral foramen. Specifically, the pointed, beveled tip of sleeve 112 is inserted percutaneously, and probe 116 is inserted through luer lock fitting 114 of sleeve 112 and positioned at the target site for resection of the intervertebral foraminal ligament. The probe 116 is used to confirm whether the sleeve is positioned correctly. Once the sleeve is positioned correctly and contacts the ligament in the intervertebral foramen, probe 116 is removed, and guidewire 118 is inserted through luer lock fitting 114 to perform puncture. In this state, the sleeve is released, and guidewire 118 is twisted and passed through trocar 120 until it reaches the intervertebral foraminal position. In this way, the guide wire 118 guides the trocar 120 to the target site for ligament resection while avoiding contact with the nerves that are distributed along with the ligament in the intervertebral foramen. Once the trocar 120 is correctly positioned, the guide wire 118 is removed and the cannula 132 is passed through the trocar 120. Once the cannula 132 is in place, the trocar 120 is removed and a curette 140 is inserted to resect the ligament located at the target site for ligament resection in the intervertebral foramen. The ligament released by the resection operation is pulled out of the cannula using forceps (not shown).

[0021] The proposed surgical tool is inserted to the target point for resecting the intervertebral foraminal ligament in a posterior-lateral local penetration manner, and then gradually larger diameter tools are inserted to secure the intervertebral foramen and release the ligament, thereby preventing damage to the nerve root during the probe insertion process.

[0022] However, this surgical tool set has a drawback: the local penetration process of the sleeve, probe, and guidewire, which is performed as a preliminary step to correctly positioning the trocar at the target site, is very cumbersome and difficult. Specifically, the sleeve 112, probe 116, and guidewire 118 are very thin and needle-like. Furthermore, because the sleeve 112, probe 116, and guidewire 118 are held with the fingertips for local penetration, a great deal of force is required to insert them through the skin and muscle layer to the target site for ligament resection. Furthermore, it is very difficult to accurately position them at the target site while changing direction using only the force of the fingers. This means that it is very difficult to resect the ligament that runs from the lateral surface of the facet joint to the epidural space in order to create a tunnel that penetrates from the outside to the inside (epidural space) of the intervertebral foramen.

[0023] Figure 4 is a fluoroscopic image showing the process of foraminal ligament resection. Figure 4 is excerpted from a research paper by Sang Chul Lee et al. (2017) on the effectiveness of lumbar foraminal extraforaminotomy ("Effectiveness of Percutaneous Lumbar Extraforaminotomy in Patients with Lumbar Foraminal Spinal Stenosis: A Prospective, Single-Armed, Observational Pilot Study," Pain Medicine 2017; Vol. 18 (10): 1975-1986).

[0024] As shown in the figure, photograph (A) shows the probe 116 entry point, located 12 to 14 cm away from the midline of the spine. The practitioner, who is performing the entry and C-arm imaging, grasps the probe 116 with forceps and performs the entry and imaging process. This process demonstrates the difficulty of percutaneously penetrating the muscle layer to the ligament target point. Photograph (B) is a lateral view showing the cannula 132 being advanced until its tip is positioned posterior to the boundary between the inferior and superior articular processes. Photograph (C) is an AP view showing the curette 140 inserted into the cannula 132 until its tip reaches the medial border of the vertebral pedicle, detaching the ligament and performing mechanical adhesion release. Photograph (D) is an angiographic image of the epidural space after adhesion release before injection of local anesthetic and corticosteroid.

[0025] As described above, in order to overcome the problems of the intervertebral foraminal dilation using the conventional surgical tools, the applicant of the present application proposed a percutaneous intervertebral foraminal dilation surgical tool by foraminal ligament resection in US Pat. No. 9,649,129. As shown in FIG. 5, this patent includes a trocar 202 for penetrating the skin and entering the intervertebral foramen; a cannula 204 having a handle 212 and a sleeve 214 with a guide hole 214a, into which the trocar 202 is inserted to reach the target resection position in the intervertebral foramen; an end mill 206 having a handle 216 and a blade tip 218 attached integrally to the tip, inserted into the cannula 204 to scratch the fine ligaments closing the intervertebral foramen; and a curette 208 inserted into the cannula 204, having a handle 220 at one end and a concave scraper tip 222 at the tip, to further separate the torn ligament attached to the intervertebral joint and scrape away any remaining material.

[0026] The surgical tool with the above structure also has a trocar in the shape of a thin needle, which makes it very difficult to grasp the trocar with the fingertips and penetrate it locally through the muscle layer to the target point for ligament resection. In addition, the trocar may bend during the insertion process through the muscle layer, which makes it very difficult to properly place the trocar in the correct position.

[0027] Meanwhile, U.S. Patent No. 9,456,829 and Japanese Patent Application Laid-Open No. JP2010-502305 disclose tissue modification instruments. In these patents, as shown in FIG. 6, a guide member 316 is clamped to an introduction device 314 that has penetrated the intervertebral joint, and a body 308 equipped with a dissection member 310 for dissecting ligaments penetrates the guide member 316, contacting the ligamentous portion of the intervertebral foramen and then protruding from the outside of the intervertebral joint. In these prior patents, the dissection member 310 dissects the ligament as the body 308 is moved by the operation of a handle 304 and an actuator 306 provided on the introduction device 314.

[0028] The above structure is a tool for separating ligaments in the intervertebral foramen by rubbing the separating member 310 against the ligaments in the intervertebral foramen while moving the body 308 from side to side. Not only is it difficult to accurately position the body 308 in the complicatedly entangled area in the intervertebral foramen, but there is also a risk of damaging the surrounding nerve tissue in the process of separating the ligaments by rubbing the body from side to side.

[0029] Additionally, U.S. Patent Publication No. 2011 / 0288553 provides a system and method for treating spinal stenosis, and U.S. Patent Publication No. 2008 / 0195084 discloses a working tool for use in medical surgery, the working tool having a handle and extending along a common axis. [Prior art documents] [Patent documents]

[0030] [Patent Document 1] U.S. Patent No. 4,573,448 (registered March 4, 1986) [Patent Document 2] U.S. Patent No. 9,649,129 (issued May 16, 2017) [Patent Document 3] U.S. Patent No. 9,456,829 (registered April 4, 2016) [Patent Document 4] Japanese Patent Application Publication No. 2010-502305 (Published January 28, 2010) [Patent Document 5] U.S. Patent Publication No. 2011 / 0288553 (Published November 24, 2011) [Patent Document 6] U.S. Patent Publication No. 2008 / 0195084 (Published August 14, 2008) [Non-patent literature]

[0031] [Non-Patent Document 1] Jun-Hong Min, et.al. “Anatomic analysis of the transforaminal ligament in the lumbar intervertebral forman” operative neurosurgery2005, Vol.57(1):37~41 [Non-patent document 2] Sang Chul Lee, et.al., "Effectiveness of Percutaneous Lumbar Extraforaminotomy in Patients with Lumbar Foraminal Spinal Stenosis: A Prospective,Single-Armed,Observational Pilot Study" Pain Medicine2017;Vol18(10):1975-1986. Summary of the Invention [Problem to be solved by the invention]

[0032] The present invention has been made to solve the above-mentioned problems, and aims to provide a percutaneous foraminal dilation surgical tool set that has a handle attached to the stylet member, trocar, cannula, and curette that make up the foraminal dilation surgical tool, improving straightness and directionality in the process of percutaneously passing through the muscle layer to reach the target point for resecting the transverse foraminal ligament, and facilitating direction changes (steerability) in the process of resecting the ligament.

[0033] Another object of the present invention is to provide a percutaneous foraminal dilation surgical tool set that can reduce bleeding during the primary and secondary ligament resection process by passing the foraminal dilation tool percutaneously through the muscle layer to reach the target site for transverse foraminal ligament resection, thereby maximizing the safety of the procedure.

[0034] Another object of the present invention is to provide a percutaneous foraminotomy tool set that allows the stylet member, trocar, and cannula to be gripped not simply with the fingertips, but by fundamentally improving the grip of the tool, thereby enabling accurate and reliable angle of incidence to be achieved from the spinal facet joint to the target site for ligament resection during the introduction process of finding and entering the ligament in the intervertebral foramen.

[0035] Another object of the present invention is to provide a method of performing a percutaneous intervertebral foraminal dilation procedure using a tool set that allows the stylet member of the tool set to first accurately reach the target position for intervertebral foraminal ligament resection, and secondarily, allows the trocar to stably perform the introduction process of finding and entering the ligament in the intervertebral foramen, and the resection process of resecting the ligament from the target point for ligament resection to the epidural space.

[0036] Another object of the present invention is to provide a method for treating disc aneurysms using a percutaneous foraminotomy instrument set that can restore disc height by filling the disc space with hydrogel and simultaneously widen the intervertebral foraminal space, thereby improving the effectiveness of subsequent foraminotomy procedures and reducing acute pain in the early stages of the procedure. [Means for solving the problem]

[0037] The present invention provides a trocar that includes a long, thin probe, a guide tube into which the probe can be inserted and separated, a cap attached to the probe, and a hub body attached to the guide tube and connected to the cap, the trocar having a stylet member for reaching a transverse ligament target point; a needle having a groove formed at a predetermined position and a needle tip with a sharp distal end; and a first handle that is held by the needle and applies force to the needle in accordance with the percutaneous incidence angle of the spinal facet joint, the trocar being guided by the guide tube of the stylet member to reach the transverse ligament target point and pierce the ligament; a sleeve that is formed larger in diameter than the trocar and has a through hole in the axial direction so that the trocar can be held; and a sleeve that is formed larger in diameter than the trocar and has a through hole in the axial direction so that the trocar can be held. The curette includes a cannula having a fixation shaft located in the center for clamping and fixing one end of a sleeve, and a handle with a mounting portion formed on its rear surface, and for reaching the target point for ligament resection in the intervertebral foramen under the guidance of the trocar; a rod clamped in the sleeve of the cannula; a resection tip attached to the tip of the rod for releasing the ligament at the target point for resection, scraping up the remains of the primarily resected ligament, and pushing it into the intervertebral foramen; and a second handle mounted on the mounting portion of the cannula.

[0038] In an embodiment of the present invention, the distal end of the probe and guide tube of the stylet member has a beveled end surface and a curved portion where the lower part of the beveled end surface is rounded. This structure allows the stylet member to advance toward the target point while minimizing tissue damage when the curved portion hits a nerve or other important tissue during the process of entering the intervertebral foramen.

[0039] In the present invention, the stylet member has a handle formed by coupling a locking lever attached to the cap with a locking groove formed in the hub body. Furthermore, the cap and hub body of the stylet member have multiple grooves formed on their outer circumferential surfaces, which prevents the weight of the stylet member from shifting toward the cap and improves grip, allowing for stable injection of contrast medium or medication through the hub.

[0040] In one embodiment of the present invention, the first handle of the trocar includes a body having a longitudinal groove formed in the center and a storage space recessed to a certain depth on one side; a stepped portion formed at the rear end of the body to provide a gripping force to the practitioner; a shaft sandwiched in the storage space; and a lever having a round pressure portion that contacts the groove of the needle to apply pressure, the shaft sandwiched in the center of the pressure portion and rotating within the storage space to lock and unlock the needle.

[0041] In one embodiment of the present invention, the needle further includes a direction indicator formed on a flat surface on the top of the distal end of the body, which serves as a reference for the needle's angle of entry and on which the practitioner's thumb can apply pressure.

[0042] The body also includes coupling grooves formed on both sides of the mounting portion and joint grooves formed on both sides of the fixed shaft to allow the practitioner's joints to rest on and improve gripping.

[0043] The sleeve of the cannula has a tapered section at a certain section on the distal end side, and is exposed to the outside of the tapered section with a gradient corresponding to the gradient of the tapered section.

[0044] In an embodiment of the present invention, the tapered portion of the sleeve and the distal end of the resection tip of the curette are joined together without any gap.

[0045] The cannula shaft and the first handle of the curette are characterized in that coupling protrusions are provided on both sides of the second handle of the curette so as to be sandwiched in the coupling groove of the holder so as to be integrated.

[0046] The resection tip of the curette is characterized by having a recessed central portion for scraping the transverse ligament surrounding the intervertebral foramen, and a rim portion formed rounded around the recessed portion.

[0047] The resection tip of the curette has a straight section that can fit closely to the inner surface of the tapered portion of the cannula sleeve, and protrudes while being sandwiched between the tapered portion of the sleeve. The gap between the tapered portion and the end of the resection tip has a tolerance ranging from a transition fit to a clearance fit.

[0048] The rim portion formed on the resection tip of the curette is characterized in that the distal end is rounded.

[0049] The present invention includes a first step of examining various ligaments around the intervertebral foramen; a second step of determining the insertion position of the stylet member and trocar according to the ligament structure around the intervertebral foramen, which differs from patient to patient; a third step of inserting the stylet member through the skin adjacent to the intervertebral foramen (intervertebral joint) toward the target point of the incision; a fourth step of confirming the position of the stylet member by injecting a contrast agent; a fifth step of filling the disc space with hydrogel to restore the disc height; and a fifth step of inserting a trocar into the target point of ligament resection, guided by the guide tube of the stylet member. a seventh step of performing a primary resection; an eighth step of inserting the trocar into a cannula and then removing the trocar to secure space for inserting subsequent tools; a ninth step of connecting a curette to the cannula to perform a secondary ligament resection; and a tenth step of inserting a catheter into the intervertebral foramen, appropriately delivering a chemical substance to the area around the nerve branch that induces pain, and then discharging inflammatory substances present in the intervertebral foramen together with the chemical substance through the intervertebral foramen.

[0050] In an embodiment of the present invention, the fifth step is characterized by filling the disc space with hydrogel through a guide tube of the stylet member. [Effects of the Invention]

[0051] As described above, the present invention achieves the following effects.

[0052] First, the stylet element, which is initially inserted to find the target site for ligament resection in the intervertebral foramen, is composed of a probe and a guide tube. It prevents the guide tube from becoming clogged with tissue when advanced percutaneously through the muscle layer to the target site in the intervertebral joint. Furthermore, a molar-shaped cap is attached to the end of the probe, a hub body is attached to the guide tube, and grooves are formed in the cap and hub body, maximizing the practitioner's grip and allowing for consistent force to be applied to the stylet. This improves linearity and directionality during percutaneous insertion, allowing for accurate advancement to the target site in the intervertebral joint in a short time and reducing bleeding. Furthermore, the ends of the probe and guide tube are formed with inclined surfaces and are bent. As a result, the bent portions do not come into contact with nerves or other important tissues during the advancement process, minimizing tissue damage during the insertion process.

[0053] Second, grooves formed at regular intervals on the outer periphery of the cap and hub reduce the weight of the handle by approximately half, preventing the center of gravity of the stylet from shifting excessively toward the handle and maintaining overall weight balance, enabling stable injection of contrast medium or medication. Furthermore, once the probe and guide tube reach the target site for ligament resection, the probe can be separated and contrast dye can be injected into the epidural space through the hub, allowing medication to be injected accurately without the guide tube tip moving away from the target site for ligament resection.

[0054] Third, inserting hydrogel into the disc space to restore disc height while widening the intervertebral foramen space can enhance the effectiveness of subsequent foraminotomy procedures. In other words, as the intervertebral foramen widens, the buckling on the facet joint capsule unfolds, smoothing the facet joint surface. As a result, the subsequent ligament resection, which involves squeezing and releasing the ligaments at the facet joint from the point of entry of the superior articular process through the facet joint surface to the inferior articular process, allows for easier and faster ligament resection and release, shortening the procedure time. Furthermore, by promoting more accurate and safer ligament resection, the frequency and duration of nerve contact and nerve swelling that are unavoidable during the ligament resection process can be reduced. Therefore, acute pain caused by nerve swelling immediately after foraminotomy can be minimized, and the effect of foraminotomy can be enhanced.

[0055] Fourth, when the trocar is percutaneously advanced to the target point of the intervertebral joint, it is sufficient to advance it to the target point of the ligament resection of the intervertebral joint along the guide tube of the stylet member that has already been placed at the target point of the intervertebral joint. Therefore, compared to advancing the trocar without any guide, it is relatively easy to reach the target point of the ligament resection, and the resection preparation process can be performed very simply and quickly.

[0056] Fifth, by configuring the trocar from an elongated needle and providing a first handle with a lever for locking and unlocking the needle, the first handle can be accurately aimed from the spinal facet joint to the target point for ligament resection.

[0057] Sixth, the first handle of the trocar provides a good grip for the practitioner, facilitating the percutaneous insertion process with a precise angle of incidence during the primary resection. In particular, the first handle makes it easy to apply force to the needle, allowing it to be introduced accurately and directly through the muscle layer to the target point for ligament resection in the intervertebral foramen without deviating from the angle of incidence.

[0058] Seventh, by forming a direction indicating surface on the first handle of the trocar, it is possible to maintain a directional reference when percutaneously introducing a needle, and to easily correct deviations in the angle of incidence.

[0059] Eighth, by integrating the second handle of the curette with the shaft of the cannula, steering ability can be improved when releasing ligaments at the facet joint from the point of entry of the superior articular process through the facet joint surface to the inferior articular process side. This improved steering ability allows for quick and accurate release of ligaments along the facet joint surface.

[0060] Ninth, by minimizing the gap at the end where the cannula and curette join, it is possible to prevent rupture of the lumbar splanchnic arterioles, which can occur in the ligament resection path during foraminotomy in cases where the lumbar arterioles are distributed in an unusual location, enabling stable surgery and minimizing the occurrence of complications such as retroperitoneal hematoma.

[0061] Tenth, by minimizing the gap at the connection site between the cannula and the curette, it is possible to minimize damage to the dorsal root ganglion that may occur when the ligament is removed during foraminal dilation.

[0062] Eleventh, the sharpened top and front surfaces of the curette tip minimize the risk of damaging the dura mater, ensuring safe surgery. In other words, in conventional methods, ligament resection is performed by moving the curette primarily forward and backward using the sharpness of the side blades and front sharp edge of the curette. In contrast, the present invention uses a peel-off concept, where the curette is pulled primarily from bottom to top, and the wide, rounded rim of the curette resects the ligament. This minimizes the risk of damaging the dura mater when entering the epidural space through the ligament, ensuring safe surgery.

[0063] Twelfth, minimally invasive surgery using local anesthesia is possible, shortening the procedure time, and the target point for ligament resection can be accurately identified by injecting contrast medium. This allows for the continuous and sequential introduction of foraminotomy tools into multiple foraminal lesions in a single procedure, allowing for ligament resection. As a result, multi-segment foraminotomy can be performed on multiple intervertebral foramina in a single procedure.

[0064] Thirteenth, it is a minimally invasive procedure under local anesthesia, and the ligament is removed in a short time, so it can be performed on elderly patients or those with underlying cardiovascular diseases such as diabetes, high blood pressure, and coronary artery disease. [Brief explanation of the drawings]

[0065] [Figure 1] Distribution of ligaments around the intervertebral foramina; [Figure 2] Visual pictorial diagrams to explain the process of pain and nerve dysfunction; [Figure 3] Schematic diagram of a tool set used in prior art disc prolapse surgery; [Figure 4] Fluoroscopic video showing the foraminal ligament resection process; [Figure 5]Schematic diagram of a set of tools used in foraminal dilation according to the prior art; [Figure 6] Schematic diagram showing the process of removing the ligament in the intervertebral foramen according to the prior art; [Figure 7] FIG. 1 is an exploded perspective view showing the structure of a stylet member, which is a main part of one embodiment of the intervertebral foraminal dilation treatment tool set according to the present invention; [Figure 8] 8 is an enlarged perspective view showing in detail the connection between the hub of the stylet member and the probe cap of FIG. 7; [Figure 9] 8 is a perspective view of the stylet member of FIG. 7; [Figure 10] FIG. 1 is an exploded perspective view showing the configuration of a trocar, which is a main part of one embodiment of the intervertebral foraminal dilation treatment tool set according to the present invention; [Figure 11] 11 is a diagram illustrating the operation process of the lever of the trocar shown in FIG. 10, in which the pressure applying portion of the lever is released from the groove of the needle and the locking is released; [Figure 12] FIG. 11 is a diagram illustrating the operation process of the lever of the trocar shown in FIG. 10, in which the pressing part of the lever presses the groove of the needle to lock it; [Figure 13] A diagram showing the state in which a practitioner holds the handle of a trocar, illustrating the straightness, directionality, and steerability (direction changeability) of the trocar; [Figure 14] FIG. 1 is an exploded perspective view showing a combination of a cannula and a trocar, which are essential parts of an embodiment of the intervertebral foraminal dilation treatment tool set according to the present invention; [Figure 15] a perspective view of a trocar coupled to the cannula of FIG. 14; [Figure 16] FIG. 1 is a perspective view showing a configuration in which a curette, which is a main part of an embodiment of the intervertebral foraminal dilation treatment tool set according to the present invention, is coupled to a cannula; [Figure 17] 1 is a perspective view illustrating the junction between the cannula and the curette; [Figure 18] 1 is a perspective view showing a state in which the resection tip of the curette according to the present invention is coupled to the tapered portion of the cannula; [Figure 19]FIG. 1 is an illustrative view for explaining a structural problem caused by a gap when a resection tip is coupled to a tapered portion of a cannula according to the prior art; [Figure 20] 19A and 19B are cross-sectional views comparing the change in the gap between the cannula and the resection tip according to the prior art and the present invention, in which (A) is a cross-sectional view showing the state in which the tapered portion of the cannula and the resection tip according to the prior art of FIG. 19 are coupled together, and (B) is a cross-sectional view showing the state in which the resection tip of the curette according to the present invention of FIG. 18 is coupled to the tapered portion of the cannula; [Figure 21] A perspective view of the combined cannula and curette; [Figure 22] Bird's-eye view of the location of lumbar arterioles distributed in a typical aorta; [Figure 23] This is a distribution diagram of measurement data for the typical location of lumbar pulposus arterioles, showing the case where the lumbar pulposus arterioles are located behind the dorsal root ganglia (red circle in the center of the left figure), deviating from the typical distribution in which they are located anterior to the dorsal root ganglia. [Figure 24] A process flowchart for implementing a surgical method using the intervertebral foraminal dilation surgical tool set according to the present invention; [Figure 25] When the disc space is filled with hydrogel in step S20 of Figure 24 to restore the disc height, the intervertebral foramen space also widens, and the buckling on the capsule of the spinal facet joint spreads together, smoothing the spinal facet joint surface (see the red area). [Figure 26] FIG. 10 shows the process of filling the disc space with hydrogel to restore the disc height. DETAILED DESCRIPTION OF THE INVENTION

[0066] Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying FIGS.

[0067] The percutaneous intervertebral foraminal dilation surgical tool set of the present invention is designed to facilitate straightness, directionality, and steering (tool direction change) in the process of entering the facet joint and reaching the target point for resecting the ligament surrounding the intervertebral foramen.

[0068] Before describing the preferred embodiment of the present invention, the concept of the present invention will be explained.

[0069] First, chemical neurolysis is applied to solve the inflammatory side of the problem, while percutaneous extraforaminotomy is applied to solve the mechanical side of the problem.

[0070] The present inventors have confirmed that back pain and sciatica are caused by adhesive fibroblasts that detach from damaged discs (nucleus pulposus) and cartilage and accumulate around the transverse ligament (TFL) of the intervertebral foramen. To address the inflammatory factors that cause this pain, they have attempted a foraminal expansion procedure in which a surgical tool is inserted through the intervertebral joint to resect the transverse ligament. From the perspective of inflammatory factors rather than mechanical factors, the present inventors analyzed the physiological causes of pain and the target points of the inflammatory process, and clinically examined the anatomical structure of the intervertebral foramen and the transverse ligament (TFL). Percutaneous extraforaminoctomy with transforaminal ligament (TFL) resection is clinically important in terms of biochemical and inflammatory aspects.

[0071] The intervertebral foramen is a pathway for blood vessels (nerves, veins, arteries), lymphatic vessels, and the autonomic nervous system. The dorsal root ganglia (DRG), which are vulnerable to shock and inflammation, are located within the foramen. A spiderweb of tiny ligaments forms within the foramen, and substances derived from inflammatory reactions within the spinal canal accumulate within the foramen. Consequently, destructive reactions, such as adhesions to nerve tissue, edema due to inflammation, and restricted blood flow to the spinal canal, frequently occur within the foramen. Therefore, resolving inflammation within the foramen and decompressing entrapment neuropathy or entrapped nerve segments are crucial for successful treatment.

[0072] The main purpose of the above-mentioned concept of foraminotomy is to prevent damage to nerves and blood vessels and to decompress nerves, so the function of the surgical tools is very important for the successful completion of the procedure.

[0073] The specific shape and function of an embodiment of the surgical tool set according to the present invention that is applied to foraminal dilation will be described in detail with reference to the drawings.

[0074] Fig. 7 is an exploded perspective view showing the structure of a stylet member, which is a main component of one embodiment of the intervertebral foramina dilation surgical tool set according to the present invention; Fig. 8 is an enlarged perspective view showing in detail the connection between the hub of the stylet member and the probe cap of Fig. 7; and Fig. 9 is an assembled perspective view of the stylet member of Fig. 7. Fig. 10 is an exploded perspective view showing the structure of a trocar, which is a main component of one embodiment of the intervertebral foramina dilation surgical tool set according to the present invention; Figs. 11 and 12 are diagrams illustrating the operation of the trocar lever shown in Fig. 10, with Fig. 11 showing the lever's pressure-applying portion disengaging from the probe groove to release the lock, and Fig. 12 showing the lever's pressure-applying portion pressing against the probe groove to lock it. Fig. 13 is a diagram showing the trocar handle grasped by a surgeon, illustrating the trocar's linearity, directionality, and maneuverability.

[0075] As shown, the tool that is preferentially introduced to reach the transforaminal ligament target site for resection of the transforaminal ligament of the intervertebral foramen is a stylet member 2. The stylet member 2 comprises: an elongated probe 12 having a first oblique end surface 12a at one end; a mortar-shaped cap 14 that is clamped and fixed to the other end of the probe 12 and has grooves formed at regular intervals on its outer periphery; a locking lever 16 formed at the tip of the cap 14; a guide tube 18 that is formed as an elongated channel so that the probe 12 can be detachably clamped therein and has a second oblique end surface 18a at its end, and that percutaneously passes through the muscle layer together with the probe 12 to reach the target site for ligament resection in the intervertebral foramen; and a hub 20 that is attached to the other end of the guide tube 18 and has a hub body 22 with a locking groove 22b at one end that engages with the locking lever 16, and is used to inject contrast dye, pain-relieving medication, etc. The cap 14 and hub body 22 of the stylet member 2 function as a handle, allowing the practitioner to grip it with the entire palm of their hand and apply a constant force to the probe 12 and guide tube 18. The handle function, formed by combining the cap 14 and hub body 22, provides straightness and directionality so that the first and second oblique end faces 12a, 18a formed on the probe 12 and guide tube 18, respectively, can be advanced percutaneously through the muscle layer to the intervertebral joint, accurately aiming at the target point for ligament resection in the intervertebral foramen.

[0076] In an embodiment of the present invention, first grooves 14a are formed at regular intervals on the outer circumferential surface of the cap 14, and second grooves 22a are formed at regular intervals on the outer circumferential surface of the hub body 22 connected to the cap 14. These first and second grooves 14a, 22a improve the grip when the practitioner wraps the cap 14 and hub body 22 with the entire palm of their hand to apply a certain force to the probe 12 and guide tube 18. In addition, the first and second grooves 14a, 22a reduce the weight of the stylet member 2 so that it is not biased rearward, i.e., toward the cap 14. The first and second grooves 14a, 22a function to inject a contrast dye into the epidural space through the hub 20 after the probe 12 and guide tube 18 have reached the target point for ligament resection, thereby confirming the position of the tip of the guide tube 18 and enabling stable injection of pain-relieving medication without shaking.

[0077] Unexplained reference numeral 23 denotes an injection plug, which functions as a cover wing when coupled with a syringe to inject a contrast agent or pain relief medication after the probe 12 is separated from the guide tube 18, as shown in Figure 8. Unexplained reference numeral 21 denotes a connector for connecting to a navigation antenna or the like.

[0078] 7, the probe 12 of the stylet member 2 and the guide tube 18 have first and second bent portions 12b and 18b, respectively, which are rounded at the bottom of the first and second oblique end surfaces 12a and 18a. The first and second bent portions 12b and 18b are designed to minimize tissue damage when the first and second bent portions 12b and 18b come into contact with nerves or other important tissues during the percutaneous entry into the intervertebral foramen.

[0079] Once the target point for ligament resection has been identified through the primary stylet member, a trocar 4 is provided as a resection tool for secondary drilling of a hole in the ligament. The trocar 4 is percutaneously advanced into the facet joint by the guidance of a guide tube 18 to reach the target point for transverse ligament resection in the intervertebral foramen. It functions to guide the advancement of surgical tools (described below) while also primarily resecting the target ligament. In one embodiment of the present invention, the trocar 4 comprises a needle 24, which is a slender rod having a groove 28 formed at a predetermined position and a sharp needle tip 26; and a first handle 30, which is held by the needle 24 and applies force to facilitate directionality and straightness according to the percutaneous incidence angle of the needle 24 at the facet joint.

[0080] The first handle 30 has a groove 30a formed in the center, a direction indicator surface 30b formed as a flat surface on the upper surface of the distal end to serve as a reference for the approach angle, and a storage space 30c recessed to a certain depth on one side. A stepped portion 32 is integrally formed at the rear end of the first handle 30 to provide a gripping force to the practitioner. A lever 34 is attached to the storage space 30c of the first handle 30 and locks and unlocks the needle 24 by rotating it. The lever 34 is composed of a round pressure member 34a that contacts the groove 28 of the needle 24 to apply pressure, and a shaft 35 that is sandwiched in the center of the pressure member 34a and serves as the center of rotation.

[0081] As shown in Figure 10, when the lever 34 bends back in a direction perpendicular to the needle 24, the pressure applying portion 34a comes out of the groove 28, allowing the needle 24 to be released, and when the lever 34 is pushed into the storage space 30c and stored as shown in Figure 11, the pressure applying portion 34a is sandwiched between the groove 28 and applies pressure, thereby fixing the needle 24.

[0082] As shown in Figure 12, the practitioner grasps the first handle 30 around the direction indicator surface 30b of the trocar 4 constructed as described above and inserts it along the guide tube 18 from the intervertebral joint to the target site for resecting the transforaminal ligament. After insertion, the guide tube 18 is removed. This operation allows the needle 24 to smoothly penetrate the muscle layer percutaneously and enter the intervertebral foramen. The first handle 30 provides directionality and straightness that allows for even distribution of force in the direction the probe passes, in accordance with the angle of incidence, thereby preventing the needle from bending, a problem in the prior art, and making it easier to reach the target site for resecting the transforaminal ligament.

[0083] Next, Figure 14 is an exploded perspective view showing the combination of a cannula and a trocar, which are essential parts of one embodiment of an intervertebral foramina dilation treatment tool set according to the present invention, and Figure 15 is a perspective view showing a trocar combined with the cannula of Figure 14.

[0084] Once the trocar 4 reaches the target site for resection of the transforaminal ligament and completes the primary resection, a cannula 6 is advanced along the trocar 4 to reach the target site for resection of the transforaminal ligament. As shown in FIG. 14, the cannula 6 is comprised of a sleeve 36, which is larger in diameter than the trocar 4 and has a through-hole 36a extending in the axial direction so that the trocar 4 can be clamped therein; and a handle 38, which has a fixing shaft 38a protruding from the center to clamp and fix one end of the sleeve 36 and a mounting portion 38b formed on the rear surface. The mounting portion 38b has coupling grooves 38c (shown in FIG. 17) formed on both sides. The handle 38 has knuckle grooves 39 on both sides of the fixing shaft 38a so that the practitioner's knuckles can rest on it to improve grip. In this embodiment of the present invention, a tapered portion 37 is formed on a certain section of the distal end of the sleeve 36. This is intended to minimize the gap between the resection tip of the curette (described later) and prevent nerves from being caught in the gap and damaged when the transverse ligament is dissected, as well as to facilitate percutaneous cannula insertion through the skin.

[0085] 14 and 15, the practitioner grasps the handle 38 of the cannula 6 configured as described above and inserts the trocar 4 into the sleeve 36. The sleeve 36 is guided by the trocar 4 to reach the target point for resecting the transforaminal ligament, and once the exact resection position has been confirmed, the trocar 4 is released from the cannula 6 and removed.

[0086] Next, Figure 16 is a perspective view showing the configuration in which a curette, which is a main part of one embodiment of the intervertebral foraminal dilation treatment tool set of the present invention, is connected to a cannula; Figure 17 is a perspective view for explaining the connection between the cannula and the curette; Figure 18 is a perspective view showing the state in which the resection tip of the curette of the present invention is connected to the tapered portion of the cannula; Figure 19 is an illustrative view for explaining the structural problems caused by the gap when the resection tip is connected to the tapered portion of the cannula of the prior art; Figure 20 is a cross-sectional view comparing the change in the gap between the cannula and the resection tip of the prior art and the present invention, where (A) is a cross-sectional view showing the state in which the tapered portion of the cannula of the prior art and the resection tip are connected, and (B) is a cross-sectional view showing the state in which the resection tip of the curette of the present invention of Figure 18 is connected to the tapered portion of the cannula; Figure 21 is a perspective view of the connection in which the cannula and curette are integrated.

[0087] 16, a curette 8 is inserted into the cannula 6 to remove the transverse ligament at the target resection point. The curette 8 includes a rod 42 that is inserted into the sleeve 36, a resection tip 44 that is attached to the distal end of the rod 42 and protrudes out of the tapered portion 37 to dissect the transverse ligament, and a second handle 46 that is attached to the rear end of the rod 42 and has coupling protrusions 46a on both sides so as to be inserted into the coupling groove 38c of the cannula mounting portion 38b.

[0088] The resection tip 44 is used to scrape and remove the transverse ligament surrounding the intervertebral foramen. As shown in FIGS. 18 and 20B, it has a central recess 44a and a rounded rim portion 44b around the recess 44a. The rim portion 44b is rounded to prevent damage to the nerve membrane due to contact during the process of dissecting the transverse ligament. The resection tip 44 also has a straight section 44c that allows it to fit closely to the inner surface of the tapered portion 37 of the sleeve 36, thereby eliminating a gap 45 between the tapered portion 37 and the end of the resection tip 44. In this embodiment, the gap 45 between the tapered portion 37 and the end of the resection tip 44 has a tolerance ranging from a transition fit to a clearance fit.

[0089] If a gap 45 occurs between the tapered portion 37 and the resection tip 44, as in the prior art shown in Figures 19 and 20(A), a lumbar arteriole or nerve may become trapped in the gap 45 and rupture. Rupture of a lumbar arteriole can lead to serious retroperitoneal hematoma. Even in the unusual case of a lumbar arteriole being distributed in the transverse ligament of the intervertebral foramen, as shown in Figure 18, there is almost no gap 45 between the resection tip 44 of the curette 6 and the tapered portion 37 of the cannula 6 (meaning within the tolerance for fit and clearance), and the resection tip 44 of the curette 6 is rounded, allowing the ligament to be safely resected without damaging the lumbar arteriole.

[0090] Figure 22 is a bird's-eye view of the location of lumbar pulp arterioles distributed in a typical aorta; Figure 23 is a measurement data distribution diagram for the location of typical lumbar pulp arterioles, showing a case where the lumbar pulp arterioles are located posterior to the dorsal root ganglion (red circle in the center of the left figure), rather than the usual distribution in front of the dorsal root ganglion. In Figure 23, the left figure shows the original measurement data, and the right figure shows the standardized measurement data. Furthermore, based on the left figure, the top corresponds to the cranial side, the bottom corresponds to the coccygeal side, the left corresponds to the ventral side, and the right corresponds to the dorsal side.

[0091] Referring to Figures 22 and 23, as shown in Figure 22, the lumbar arterioles, which branch off from the aorta and wind around the lateral side of the intervertebral foramen, are generally located anterior to the dorsal root ganglion. That is, as shown in the left image of Figure 23, the filled red circle in the center of the upper left second quadrant indicates the average location of the artery. However, as shown by the hollow red circle in the left image of Figure 23, when the lumbar arteriole deviates from the typical distribution, it is located posterior to the dorsal root ganglion. This is an anomaly. Here, in the case of foraminotomy, the resection proceeds by peeling off the ligament from bottom to top from the blue shaded area labeled "dorsal" or "posterior" in the left image of Figure 23 toward the green shaded area. During this process, if a lumbar pulp arteriole anomaly occurs, in a structure such as that shown in Figure 20(A), the lumbar pulp arteriole may be caught in the gap formed at the junction between the tapered portion 37 of the cannula 6 and the resection tip 44 of the curette 8, resulting in rupture. In an embodiment of the present invention (see Figures 18 and 20(B)), the gap 45 at the junction between the tapered portion 37 and the resection tip 44 is eliminated, thereby completely preventing the lumbar pulp arteriole from being caught in the gap.

[0092] As shown in FIG. 21 , the rod 42 of the curette 8 configured as described above is sandwiched in the sleeve 36 of the cannula 6, and the resection tip 44 protrudes outside the tapered portion 37. The second handle 46 of the curette 8 is integrally connected to the mounting portion 38b of the cannula 6. The practitioner grasps the handle 38 of the cannula 6, which is integrated with the second handle 46, and changes direction up and down or left and right to dissect the transverse ligament and form a passage in the intervertebral foramen. The configuration of the curette 8 makes it easy to change direction by grasping the handle 38 of the cannula 6 during the process of resecting the transverse ligament in the intervertebral foramen. The resection tip 44 minimizes damage to the tissue surrounding the target ligament during the resection process. It also resects the damaged ligament using the trocar 4, gathers the resected ligament, and pushes it toward the outer wall of the intervertebral foramen, thereby enlarging and forming a passage in the intervertebral foramen.

[0093] Hereinafter, a method for percutaneous foraminal dilation using the foraminal dilation tool set of the present invention configured as described above will be described with reference to FIGS.

[0094] FIG. 24 is a process flowchart for implementing a surgical method using the intervertebral foraminal dilation surgical tool set of the present invention; FIG. 25 is a diagram showing the process in which, when the disc space is filled with hydrogel to restore disc height in step S20 of FIG. 24, the intervertebral foraminal space also widens, the buckling on the capsule of the spinal facet joint also expands, and the spinal facet joint surface becomes smooth (see the red area); and FIG. 26 is a diagram showing the process in which the disc space is filled with hydrogel to restore disc height.

[0095] First, before performing the foraminal dilation procedure, the various ligaments surrounding the intervertebral foramen are examined (S12). The insertion positions of the stylet member 2 and trocar 4 are determined based on the ligament structure surrounding the intervertebral foramen, which varies from patient to patient (S14). In the present invention, the target for incision is determined in the intervertebral foramen opposite the disc space connected to one side of the intervertebral foramen. In this case, the edge of the intervertebral foramen is the target location, without being in close contact with the dorsal root ganglion (DRG). After step S14, the probe 12 and guide tube 18 of the stylet member 2 are coupled together and inserted percutaneously through the muscle layer to the target location for resection of the transforaminal ligament (S16). Since the handle is formed by combining the cap and hub body, a certain force can be applied to the probe 12 and guide tube 18 while the surgeon firmly grasps the handle, enhancing the linearity and directionality of the stylet member 2 as it reaches the target location for foraminal ligament resection. In addition, first and second grooves 14a, 22a are formed at regular intervals in the cap 14 and the hub body 22 to improve grip and balance, allowing for stable injection of contrast media or pain-relieving medication through the hub 20 without shaking during the procedure. A contrast media is injected into the guide tube 18 of the stylet member 2 to confirm whether the stylet member is positioned at the target point for ligament resection (S18).

[0096] The tip of the guide tube 18 of the stylet member 2 is then moved into the disc space while checking its position via the C-arm. At this time, the tip of the guide tube 18 is finally positioned accurately within the desired disc space using a discogram. After that, hydrogel is injected into the disc space via the guide tube 18, and it is confirmed whether the disc height has been properly restored (S20). At this time, once the disc height has been properly restored, the narrowed intervertebral foramen space also widens (see Figures 25 and 26).

[0097] Adding step S20, as shown in Figure 25, fills the disc space with hydrogel, fully restoring disc height and expanding the intervertebral foramen space during this process. As a result, the buckling on the facet joint capsule unfolds, smoothing the facet joint surface. Therefore, during the ligament resection process using a trocar in step S22 (described below), the ligament at the facet joint is squeezed from the point of entry of the superior articular process through the facet joint surface toward the inferior articular process, and the ligament is excised and separated along the joint line more easily and quickly, reducing the surgical time. This also facilitates more accurate and safer ligament resection. Figure 26 compares the condition before and after filling the disc space with hydrogel to restore disc height, showing the change in the size of the intervertebral foramen.

[0098] After confirming that the disc height and intervertebral foraminal space have been widened, the tip of the guide tube 18 of the stylet member 2 is again positioned at the target point for ligament resection. Next, a trocar 4 is inserted along the inserted guide tube 18 through the skin adjacent to the intervertebral foraminal area (intervertebral joint) toward the target point for transverse ligament resection (S22). In the previous step, the insertion positions of the stylet member 2 and trocar 4 are confirmed via the C-arm.

[0099] During the process of inserting the elongated needle 24 of the trocar 4 into the resection target site, the practitioner grips the first handle 30 to insert the needle 24 into the determined target position, making it easy to adjust the direction of the incident angle. That is, the direction indicator surface 30b is formed on the upper surface of the first handle 30, allowing for accurate insertion without deviation in the angle of incidence. Furthermore, because the needle 24 has an elongated shape, it may bend as it passes through the muscle layer percutaneously. However, as shown in FIG. 13 , the practitioner applies pressure with a constant force while pressing the direction indicator surface 30b of the first handle 30 as a reference point, preventing deviation in direction and evenly distributing the force, allowing the needle 24 to advance straight without bending. Furthermore, when the trocar 4 reaches the resection target site, the primary ligament resection is performed. At this time, the practitioner dissects the first handle 30 by squeezing it from bottom to top at the intervertebral foramen target site (S24). That is, when releasing the ligament at the facet joint area from the point of incidence of the superior articular process through the facet joint surface to the inferior articular process side, as shown in Figure 13, the surgeon changes direction from bottom to top (in the direction of the arrow) and performs a primary incision with the needle tip 26 to create a tunnel in the intervertebral foramen.

[0100] After the primary resection is completed, the sleeve 36 of the cannula 6 is advanced using the needle 24 of the trocar 4 as a guide to secure space for inserting subsequent tools. Then, the trocar 4 is removed using the sleeve 36 of the cannula 6 (S26).

[0101] After removing the trocar 4, the rod 42 of the curette 8 is inserted into the sleeve 36 of the cannula 6, and the resection tip 44 protrudes outside the tapered portion 37 and is positioned at the target point for ligament resection. Once the curette 8 is inserted into the cannula 6, the second handle 46 of the curette 8 is attached to the mounting portion 38b of the handle 38, forming an integrated unit. The practitioner grasps the handle 38, which is integrated with the second handle 46, and turns the direction to further dissect the injured ligament attached to the intervertebral joint, scraping out any remaining material, and widening the passage through the intervertebral foramen (S28). The curette 8 is then removed, with the sleeve 36 of the cannula 6 remaining in the intervertebral foramen. Finally, a catheter is inserted into the intervertebral foramen through the sleeve 36 of the cannula 6 to appropriately deliver pain-controlling biochemical substances to the area surrounding the pain-inducing nerve branch, and then inflammatory substances present in the spinal canal, along with inflammation-inducing substances, are discharged through the intervertebral foramen (S30).

[0102] The present invention described above is not limited to the above-described embodiments and the accompanying drawings, and it will be obvious to those skilled in the art that various substitutions, modifications and changes can be made within the scope of the technical idea of ​​the present invention. [Explanation of symbols]

[0103] 2: stylet member, 4: trocar 6: Cannula, 8: Curette 12: Probe, 14: Cap 16: Locking lever, 18: Guide tube 20: Hub, 22: Hub body 23: injection plug, 24: needle 26: Needle tip, 28: Groove 30: First handle, 32: Stepped portion 34: Lever, 35: Shaft 36: Sleeve, 37: Tapered portion 38: Handle, 42: Rod 44: Resection tip, 45: Gap 46: Second handle

Claims

1. a stylet member for reaching a transverse ligament target site, the stylet member comprising an elongated probe, a guide tube into which the probe can be inserted and separated, a cap attached to the probe, and a hub body attached to the guide tube and coupled to the cap; a trocar including a needle having a groove formed at a predetermined position and a needle tip having a sharpened distal end, and a first handle for being held by the needle and applying a force to the needle in accordance with the percutaneous incidence angle of the spinal facet joint, the trocar reaching a target point in the transverse ligament and drilling a hole in the ligament by the guidance of the guide tube of the stylet member; a cannula comprising: a sleeve formed larger in diameter than the trocar and having a through hole in the axial direction so that the trocar can be clamped; a fixing shaft located in the center for clamping and fixing one end of the sleeve; and a handle having a mounting portion formed on its rear surface, the cannula being guided by the trocar to reach the target point for ligament resection in the intervertebral foramen; a curette including a rod that is clamped in the sleeve of the cannula, a resection tip that is provided at the distal end of the rod to separate the ligament at the resection target point, scrape up the remains of the primarily resected ligament, and push them into the intervertebral foramen, and a second handle that is placed on the mounting portion of the cannula; A percutaneous foraminal dilation treatment tool set including:

2. The percutaneous intervertebral foraminal dilation treatment tool set according to claim 1, wherein the distal end of the probe of the stylet member and the distal end of the guide tube each have a beveled end surface and a curved portion in which the lower part of the beveled end surface is rounded.

3. The percutaneous intervertebral foraminal dilation treatment tool set according to claim 2, wherein the cap and the hub body of the stylet member have a plurality of grooves formed on the outer circumferential surface.

4. The stylet member includes:

3. The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 2, wherein a locking lever attached to the cap is coupled to a locking groove formed in the hub body to form a handle.

5. The first handle of the trocar includes: a body having a longitudinal groove formed in the center and a storage space recessed to a certain depth on one side; a stepped portion formed at a rear end of the body for providing a gripping force to a practitioner; a shaft sandwiched in the storage space; a round pressure member that contacts the groove of the needle and applies pressure to the needle; a lever that has a shaft sandwiched in the center of the pressure member and rotates within the storage space to lock and unlock the needle; 2. The percutaneous foraminal dilation procedure tool set according to claim 1, comprising:

6. The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 5, further comprising a direction indicating surface formed on a flat surface on the upper surface of the tip of the body, which serves as a reference for the needle's insertion angle and on which the practitioner's thumb can apply pressure.

7. The body is coupling grooves formed on both sides of the mounting portion; The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 5, further comprising knuckle grooves formed on both sides of the fixing shaft, for receiving the knuckles of the practitioner's fingers to improve gripping feeling.

8. 2. The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 1, wherein a certain section of the distal end of the sleeve of the cannula is formed as a tapered section having a slope.

9. The percutaneous foraminal dilation treatment tool set according to claim 8, further comprising coupling protrusions provided on both sides of the first handle of the curette so as to be sandwiched in the coupling grooves of the mounting part.

10. The resection tip of the curette 2. The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 1, characterized in that it has a concave recess in the center for scraping the transverse ligament surrounding the intervertebral foramen, and a rim portion formed rounded around the periphery of the recess.

11. The resection tip is The percutaneous intervertebral foraminal dilatation treatment tool set according to claim 10, characterized in that it has a straight section that can be closely fitted to the inner surface of the slope of the tapered section, is sandwiched between the tapered section of the sleeve and protrudes, and there is no gap between the tapered section and the end of the resection tip.

12. The percutaneous intervertebral foraminal dilation treatment tool set according to claim 1, wherein the rim portion formed on the resection tip of the curette has a rounded distal end.

13. The first step is to examine the various ligaments around the intervertebral foramen; a second step of determining the insertion positions of the stylet member and the trocar in accordance with the ligamentous structure around the intervertebral foramen, which differs from patient to patient; a third step of inserting a stylet member through the skin adjacent to the foraminal area (the intervertebral facet joint) toward the target point of the incision; a fourth step of injecting a contrast agent to confirm the position of the stylet member; a fifth step of filling the disc space with hydrogel to restore the disc height; A sixth step of inserting a trocar into the ligament resection target site guided by the guide tube of the stylet member; A seventh step of performing a primary resection operation; an eighth step of inserting the trocar into the cannula and then removing the trocar to secure space for inserting a subsequent tool; a ninth step of connecting a curette to the cannula to perform a secondary ligament resection; a tenth step of inserting a catheter into the intervertebral foramen, appropriately delivering a chemical substance to the area around the nerve branch that induces pain, and then expelling inflammatory substances present in the intervertebral foramen together with the chemical substance through the intervertebral foramen; A method for performing intervertebral foraminal dilatation using a percutaneous intervertebral foraminal dilatation treatment tool set including:

14. 14. The method for performing a percutaneous intervertebral foraminal dilatation procedure using a tool set for percutaneous intervertebral foraminal dilatation procedure according to claim 13, wherein the fifth step is to fill the disc space with hydrogel through the guide tube of the stylet member.

Images