Guide assembly for transforaminal approach to the lumbar spine and method of operation thereof

Abstract

The present application belongs to the technical field of medical devices, and provides a guide assembly for a superior articular process approach of a lumbar vertebra and an operation method thereof. The guide assembly comprises a guide rail, a guide needle, a bone removal assembly and a working assembly. The guide rail is provided with a guide track. The guide needle is slidably arranged in the guide rail and is used to establish an initial positioning path to the intervertebral space. The initial positioning path is parallel to the guide track. The guide rail is adapted to move along the initial positioning path. The bone removal assembly is detachably connected to the guide rail to remove bone mass of the superior articular process approach and form a bone window. The working assembly comprises a working sleeve which is adapted to be connected to the guide rail to form a working channel after the bone removal assembly is removed. The guide needle establishes the initial positioning path to the intervertebral space to confirm the position of the guide rail, reduces the number of repeated verification and adjustment under fluoroscopy, and thus reduces the radiation exposure dose of the patient. The bone removal assembly and the working assembly connected to the guide rail can be performed according to the guide track, and the possibility of path loss is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a guide component and its operation method via the translumbar superior articular approach. Background Technology

[0002] In endoscopic lumbar interbody fusion surgery, establishing a stable, precise, and safe working channel is a crucial prerequisite for surgical success. Currently, the widely used lumbar interbody fusion surgery still faces the following technical bottlenecks in establishing this working channel: First, the puncture positioning procedure is highly dependent on the surgeon's personal experience and requires repeated verification and adjustment under X-ray fluoroscopy. This not only makes it difficult to consistently guarantee surgical precision but also significantly increases the radiation exposure dose for both the surgeon and the patient. Second, the process of establishing the bone window and working channel step by step requires frequent changes and adjustments to different instruments. This process can easily lead to deviations or even loss of the initially established correct path, reducing surgical efficiency.

[0003] Therefore, there is an urgent need for a guiding component to address the shortcomings of existing technologies, such as high radiation exposure doses for both the operator and the patient during the establishment of the working channel, and the ease with which the correct path can be deviated from or even lost. Summary of the Invention

[0004] This invention provides a guide component for the translumbar approach, which addresses the shortcomings of existing technologies, such as high radiation exposure doses for both the surgeon and patient during the establishment of the working channel, and the tendency for the correct path to deviate or even be lost.

[0005] This invention provides a guide assembly via the supra-lumbar articular approach, comprising: The guide rail is equipped with a guide track; A guide needle is slidably inserted through the guide rail to establish an initial positioning path to the intervertebral space, the initial positioning path being parallel to the guide rail; the guide rail is adapted to move along the initial positioning path. A bone removal assembly is detachably connected to the guide rail to remove bone formation windows in the upper articular approach. A working component includes a working sleeve adapted to connect with the guide rail to form a working channel after the bone removal component has been removed.

[0006] The guide assembly provided by this invention, which uses a guide needle to establish an initial positioning path to the intervertebral space, confirms the position of the guide rail, reduces the number of times it needs to be repeatedly verified and adjusted under X-ray fluoroscopy, thereby reducing the patient's radiation exposure dose. The bone removal assembly and working assembly connected to the guide rail can follow the guide rail, reducing the possibility of path loss.

[0007] According to one embodiment of the present invention, the bone removal component includes: A guide, which passes through the guide rail and has a guide channel; A bone chisel, adapted to move along the guide channel to remove bone-forming windows in the superior articular approach.

[0008] According to one embodiment of the present invention, the bone removal assembly includes a set of bone chisels with increasing diameters, the bone chisels being used to progressively enlarge the bone window.

[0009] According to one embodiment of the present invention, the cross-sectional shape of the bone chisel is U-shaped or elliptical.

[0010] According to one embodiment of the present invention, the working sleeve is one of a hollow working sleeve, a closed working sleeve, and a semi-open sleeve.

[0011] According to an embodiment of the present invention, the working component includes: An expansion cannula, adapted to be connected to the guide rail after the bone removal assembly has been removed, the expansion cannula being used to expand soft tissue, and a working cannula being fitted over the expansion cannula.

[0012] According to one embodiment of the present invention, the working assembly includes a set of expansion sleeves with increasing diameters, the expansion sleeves being used to progressively expand the soft tissue.

[0013] According to one embodiment of the present invention, the working component includes an endoscope, the working channel includes an instrument channel and an endoscope channel, the instrument channel and the endoscope channel are parallel, the endoscope passes through the endoscope channel, and the working component includes a bone graft device adapted to be implanted into an interbody fusion device through the instrument channel.

[0014] According to one embodiment of the present invention, the guide rail is provided with an isolation structure, the isolation structure being used to isolate the exit nerve root; The method of operating the guide assembly via the supra-lumbar articular approach provided in the second aspect embodiment of the present invention includes the following steps: Track setting procedure: Insert the guide needle into the puncture point to establish an initial positioning path to the intervertebral space; Guided procedure: Slide the guide rail along the guide needle to insert the guide rail along the initial positioning path until it reaches the intervertebral space; Windowing procedure: Remove the guide pin, connect the bone removal assembly to the guide rail, and operate the bone removal assembly along the guide rail to remove the bone formation window in the upper joint approach. Procedure: Remove the bone removal assembly and connect the working sleeve to the guide rail to form a stable working channel at the bone window.

[0015] According to one embodiment of the present invention, the bone removal assembly includes a guide and a bone chisel, and the fenestration step includes: The guide is inserted into the guide rail; The bone chisel is moved along the guide channel of the guide to remove bone.

[0016] According to one embodiment of the present invention, moving the bone chisel along the guide channel of the guide to remove bone includes: A set of bone chisels with increasing diameters are used sequentially along the guide channel to gradually enlarge the bone window.

[0017] According to an embodiment of the present invention, connecting the working sleeve to the guide rail includes: Connect the expansion cannula to the guide rail to expand the soft tissue; The working sleeve is placed over the expansion sleeve, and after it is securely installed, the expansion sleeve is removed.

[0018] According to one embodiment of the present invention, connecting the expansion sleeve to the guide rail to expand soft tissue includes: A set of expansion sleeves with increasing diameters are sequentially connected to the guide rail to expand the soft tissue step by step.

[0019] According to an embodiment of the present invention, after the path formation step, the method further includes: Execution steps: Insert surgical instruments through the working channel to perform at least one of the following procedures: discectomy, endplate treatment, bone grafting, or interbody fusion implantation.

[0020] According to an embodiment of the present invention, the working cannula is provided with an endoscope channel and an instrument channel parallel to the guide rail, the instrument channel and the endoscope channel being independent of each other, and the execution steps include: Place the endoscope in the endoscope channel to perform endoscopic procedures; The bone graft device is placed in the instrument channel for bone grafting.

[0021] According to an embodiment of the present invention, prior to the orbit determination step, the following steps are included: Location procedure: Locate the puncture point by the intersection of the surface projection of the longitudinal line of the outer edge of the superior articular process and the superior endplate line. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the assembly structure of the guide rail and guide pin of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0024] Figure 2 This is a schematic diagram of the assembly structure of the guide rail and bone removal component of the guide assembly for the translumbar superior articular approach provided in one embodiment of the present invention.

[0025] Figure 3 This is a schematic diagram of the assembly structure of the guide rail and working component of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0026] Figure 4 This is a schematic diagram of the assembly structure of the guide rail and working component of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0027] Figure 5 This is a schematic diagram of the assembly structure of the guide rail and working component of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0028] Figure 6 This is a schematic diagram of the guide rail structure of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0029] Figure 7 This is a schematic diagram of the guide of the guide assembly for the translumbar superior articular approach provided in an embodiment of the present invention.

[0030] Figure 8 This is a schematic diagram of the bone chisel structure of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0031] Figure 9 This is a schematic diagram of the assembly structure of the guide rail and guide pin of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0032] Figure 10 This is a schematic diagram of the assembly structure of the guide rail and guide of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0033] Figure 11This is a schematic diagram of the assembly structure of the guide rail and guide of the guide assembly for the translumbar approach provided in another embodiment of the present invention.

[0034] Figure 12 This is a schematic diagram of the assembly structure of the guide rail and bone removal component of the guide assembly for the translumbar superior articular approach provided in one embodiment of the present invention.

[0035] Figure 13 This is a schematic diagram of the assembly structure of multiple bone chisels and guide rails in the bone removal component of the guide assembly via the lumbar supra-articular approach provided in an embodiment of the present invention.

[0036] Figure 14 This is a schematic diagram of the assembly structure of the guide rail and working sleeve of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0037] Figure 15 This is a schematic diagram of the assembly structure of the guide rail and the hollowed-out working sleeve of the guide component of the lumbar superior vertebral articular approach provided in one embodiment of the present invention.

[0038] Figure 16 This is a schematic diagram of the assembly structure of the guide rail and the semi-open working sleeve of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0039] Figure 17 This is a schematic diagram of the assembly structure of the guide rail and the closed working sleeve of the guide component of the translumbar approach provided in one embodiment of the present invention.

[0040] Figure 18 This is a schematic diagram of the assembly structure of the working sleeve and the expansion sleeve of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0041] Figure 19 This is a schematic diagram of the working sleeve of the guide assembly for the translumbar approach provided in one embodiment of the present invention.

[0042] Figure 20 This is a schematic diagram of the working sleeve of the guide assembly for the translumbar approach provided in another embodiment of the present invention.

[0043] Figure 21 This is a schematic diagram of the working sleeve of the guide assembly for the translumbar approach provided in another embodiment of the present invention.

[0044] Figure 22 This is a schematic diagram of the working sleeve of the guide assembly for the translumbar approach provided in another embodiment of the present invention.

[0045] Figure 23This is a schematic diagram of the working sleeve of the guide assembly for the translumbar approach provided in another embodiment of the present invention.

[0046] Figure 24 This is a schematic diagram of the operation steps of the guide assembly for the translumbar superior articular approach provided in an embodiment of the present invention.

[0047] Figure label: 100. Guide rail; 101. Guide track; 110. Isolation structure; 120. Mating part; 121. Mating groove; 122. First through hole; 130. Mounting part; 140. Second through hole; 200. Guide pin; 300, Bone removal assembly; 310, Guide; 311, Mating block; 312, First connecting post; 313, Second connecting post; 314, Sliding block; 320, Bone chisel; 321, Slide groove; 400. Working assembly; 410. Working cannula; 411. Instrument channel; 412. Endoscope channel; 413. Assembly unit; 420. Dilatation cannula. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0049] In endoscopic-assisted lumbar interbody fusion surgery, establishing an ideal working channel is the cornerstone of surgical success. Taking fully endoscopic transforaminal lumbar interbody fusion (TFE), a current research hotspot, as an example, it typically requires access to the intervertebral space via Kambin's triangle (formed by the exit nerve root, the superior endplate of the lower vertebral body, and the superior articular process). While this procedure offers the advantage of being minimally invasive, establishing the core working channel still faces a series of significant challenges: First, the initial puncture localization lacks precision and efficiency. Due to the lack of stable references to skeletal anatomical landmarks, the establishment of the puncture path is somewhat arbitrary. To ensure the puncture needle accurately enters the narrow Kambin safety triangle and avoids neurovascular damage, the surgeon must frequently rely on C-arm X-ray machines for anteroposterior and lateral fluoroscopy to repeatedly verify and adjust. This process not only significantly increases intraoperative radiation exposure but also makes the surgical procedure lengthy.

[0050] Secondly, the procedure is complex and has low tolerance for error, with a steep learning curve. The entire channel establishment process typically follows a sequence of "puncture needle - guidewire - multi-stage dilating cannula - final working cannula," involving multiple instrument changes. During this process, the elastic recoil of soft tissue, minor mismatches between instruments, or changes in the angle of operation can easily cause the initially established correct positioning path to deviate or even be completely lost, often forcing the surgeon to start over and significantly prolonging the operation time. The entire process is highly dependent on the surgeon's three-dimensional spatial imagination and rich experience, making the technique difficult to master and difficult to popularize.

[0051] Finally, and crucially, there is a lack of proactive and reliable neuroprotection mechanisms. When navigating the narrow Kambin triangle, a region teeming with vital neural structures such as the exit nerve root, traditional methods rely primarily on the surgeon's experience and visual judgment to avoid nerves. During procedures such as inserting progressively expanding cannulas or using tools like trephine saws for bone removal, neural structures are directly exposed to moving instruments, posing a high potential risk of nerve stimulation or injury. This "dynamic avoidance" rather than "static isolation" approach to protection is a major factor affecting surgical safety.

[0052] To address the limitations of the aforementioned approaches, this application proposes an optimized surgical approach via the transproximal lumbar articular process (TPAM) approach. Compared to the interlaminar approach, the TPM approach only requires treatment of the ventral bone of the superior articular process to establish a bone window, making the procedure more direct and simpler. Compared to the transforaminal approach, the working channel is more ideally positioned. By adjusting the endoscopic angle, the surgeon can not only treat the lateral region of the intervertebral foramen but also conveniently and effectively decompress the ipsilateral intervertebral foramen, central spinal canal, and even the contralateral nerve root canal. This compensates for the insufficient decompression of the central and contralateral regions by the transforaminal approach and the difficulty in exposing the lateral region of the interlaminar approach. The effectiveness of this approach stems from its ability to achieve the three major goals of nerve decompression, intervertebral disc management, and fusion cage implantation within a relatively minimally invasive channel, covering most common single-segment lumbar degenerative diseases. However, there is a severe lack of a systematic guide instrument specifically designed for this approach in clinical practice, preventing its full potential from being realized due to bottlenecks in standardized operation and safety.

[0053] This invention provides a guide component for the translumbar approach, aiming to systematically solve the defects in the prior art, such as high radiation exposure dose for both the operator and the patient during the establishment of the working channel, and the easy deviation or even loss of the correct path.

[0054] The guide assembly for the translumbar supra-articular approach provided by this invention includes a guide rail 100, a guide needle 200, a bone removal assembly 300, and a working assembly 400, as shown in the reference. Figures 1 to 3The guide rail 100 is provided with a guide rail 101; the guide needle 200 is slidably inserted through the guide rail 100 to establish an initial positioning path to the intervertebral space, the initial positioning path being parallel to the guide rail 101; the guide rail 100 is adapted to move along the initial positioning path; the bone removal assembly 300 is detachably connected to the guide rail 100 to remove bone formation windows in the superior articular approach; the working assembly 400 includes a working sleeve 410, which is adapted to be connected to the guide rail 100 after the bone removal assembly 300 is removed to form a working channel.

[0055] The guide assembly of this invention, via the supra-articular approach, establishes an initial positioning path to the intervertebral space using a guide needle 200, thus confirming the position of the guide rail 100. This reduces the number of repeated verifications and adjustments under X-ray fluoroscopy, thereby reducing the patient's radiation exposure dose. The bone removal assembly 300 and the working assembly 400, connected to the guide rail 100, can follow the guide rail 101, reducing the possibility of path loss. After the bone window is formed, the bone removal assembly 300 is removed, and the working sleeve 410 is installed. The working sleeve 410 can be connected to the guide rail 100 to form a reliable composite working channel fixed from the external body surface to the internal target point. At this time, the guide rail 100 isolates the working channel from the nerve, thereby continuously protecting the nerve. Endoscopes and various surgical instruments can be placed within the working channel, enabling safe and efficient subsequent operations such as intervertebral space treatment, bone grafting, and fusion device implantation.

[0056] Understandably, the guide rail 100 is a long component with sufficient strength. An operating handle is located at the end near the operator, and an isolation structure 110 is located at the end near the patient. The isolation structure 110 can be configured as a tongue-shaped flap to push aside and isolate the exit nerve root during the insertion of the guide rail 100 along the initial positioning path. The guide rail 100 has a guide rail 101 extending axially along the guide rail 100. The guide rail 101 can be a through-hole penetrating the guide rail 100 or an open guide groove. The guide rail 101 provides an axial reference for the entry, exit, and operation of all subsequent instruments.

[0057] In a preferred embodiment, the end of the guide rail 100 closest to the operator is provided with a locking structure (e.g., threaded interface, quick-release clip, or Luer lock connector) for quick and secure detachable connection with the bone removal assembly 300 or the working assembly 400. This design ensures seamless transitions between operational steps, preventing deviations or loss of the correct path due to instrument changes.

[0058] The end of guide rail 100 closest to the patient can be further integrated with a nerve protection plate (such as the isolation structure 110 mentioned later). Once guide rail 100 is in place along the initial positioning path, the nerve protection plate naturally sits between the working channel and the adjacent nerve root, forming a physical barrier. From the establishment of the initial positioning path until the end of the surgery, it provides continuous, passive isolation protection for the nerve, significantly reducing the risk of intraoperative nerve injury.

[0059] In one embodiment, the isolation structure 110 may be a tongue-shaped structure. The tongue-shaped structure can push aside and isolate the exit nerve root.

[0060] Understandably, the guide needle 200 can be a bone aspiration needle. Guide needle 200 can establish an initial positioning path from the skin to the target intervertebral space under image-aided guidance. The surgeon first inserts the guide needle 200 to the ideal position under X-ray fluoroscopy. After confirming the correct position of the guide needle 200, the guide rail 100 is slid along the guide needle 200 until its distal end reaches the bone surface. Because the guide rail 101 is parallel to the guide needle 200, this process ensures that the axis of the guide rail 100 is completely aligned with the ideal initial positioning path. Subsequently, the guide needle 200 can be withdrawn, at which point the guide rail 100 itself becomes a fixed, tangible physical path reference. This design fundamentally solves the problem of path deviation and loss during subsequent operations. Furthermore, since only a single precise positioning of the guide needle 200 is required, the number of fluoroscopy sessions required by traditional repeated probes is significantly reduced, directly lowering radiation exposure.

[0061] Understandably, with fluoroscopic assistance, the guide needle 200 can be inserted into the patient's area at a preset angle (e.g., abducted 30° to 40°), with the tip of the guide needle 200 reaching the intervertebral space.

[0062] Understandably, the bone removal assembly 300 is used to remove bone from the superior articular process to form a bone window, guided by the guide rail 100. Regardless of the specific instrument form used by the bone removal assembly 300, the common feature is that all bone removal operations are performed under the rigid guidance of the guide rail 100, ensuring that the preparation of the bone window is strictly carried out along a preset path.

[0063] Understandably, after the bone window is formed and the bone removal component 300 is removed, the working component 400 is installed on the guide rail 100 to establish the final working channel. The surgeon can then use this stable working channel to sequentially insert endoscopes for observation, and then use tools such as nucleus pulposus forceps, curettes, and endplate processors to manage the intervertebral space, finally implanting bone graft material and the interbody fusion cage. Because the entire procedure is performed within a fixed, protected working channel, it offers advantages such as high efficiency, good safety, and a clearly defined operating space.

[0064] According to an embodiment provided by the present invention, referring to Figure 2The bone removal assembly 300 includes a guide 310 and a bone chisel 320. The guide 310 passes through the guide rail 101 and has a guide channel. The bone chisel 320 is adapted to move along the guide channel to remove bone formation windows in the superior articular approach.

[0065] Any guide 310 with a suitable guiding channel can be used with any matching bone chisel 320, providing flexibility in instrument matching. The bone chisel 320 can be a flat chisel, a curved chisel, or a ring chisel with a protective sleeve, etc., to adapt to different bone conditions and operator habits. Of course, in some other simplified embodiments, the bone removal assembly 300 may also operate without the guide 310, and the bone chisel 320 may be directly adapted to the guide rail 101 of the guide rail 100 for operation.

[0066] It should be noted that the bone chisel 320 can slide into the predetermined location along the guide rail 101 of the guide 310 to achieve precise removal. In some embodiments, the guide 310 is provided with a slider 314 extending along the guide rail 101, and the bone chisel 320 is provided with a corresponding groove 321. The groove 321 and the slider 314 cooperate so that the handle direction is opposite to the handle direction of the guide 310.

[0067] In one embodiment, the bone chisel 320 is provided with graduation markings along the extension direction, for reference. Figure 8 The scale markings can accurately determine the depth of the chisel strike.

[0068] In one embodiment, the head of the bone chisel 320 is provided with a cutting edge for bone removal.

[0069] According to one embodiment of the present invention, the bone removal assembly 300 includes a set of bone chisels 320 with increasing diameters, which are used to progressively enlarge the bone window. In use, the surgeon can first use the initial bone chisel 320 with the smallest diameter to establish a preliminary bone window under the guidance of the guide rail 100; subsequently, larger diameter bone chisels 320 are replaced in sequence, and progressive expansion is carried out along the same guide path until a final bone window of the required size for the surgery is formed.

[0070] According to one embodiment of the present invention, the cross-sectional shape of the bone chisel 320 is U-shaped or elliptical.

[0071] In one embodiment, the bone removal assembly 300 can be a sleeve-type ring saw: its outer tube is locked to the guide rail 100, and it contains a toothed ring that can rotate at high speed. Rotating under the axial constraint of the guide rail 100, it can efficiently and concentrically remove bone, and the bone window shape is regular.

[0072] In another embodiment, the bone removal component 300 may be a bone drill guide 310 connected to the guide rail 100: it does not cut directly, but provides a stable guide channel for a small-diameter drill bit or reamer to form a bone window by gradually enlarging the aperture.

[0073] According to an embodiment provided by the present invention, referring to Figures 15 to 17 The working sleeve 410 is one of the following: hollow working sleeve, closed working sleeve, and semi-open sleeve.

[0074] According to an embodiment provided by the present invention, referring to Figure 14 or Figure 18 The working component 400 includes an expansion sleeve 420, which is adapted to be connected to the guide rail 100 after the bone removal component 300 is removed. The expansion sleeve 420 is used to expand soft tissue, and the working sleeve 410 is sleeved on the expansion sleeve 420.

[0075] The dilating cannula 420 is connected to the guide rail 100 after the bone removal component 300 is removed. Its diameter is smaller than the final working cannula 410, and its distal end is typically designed with a smooth, blunt tip. Guided by the guide rail 100, the surgeon gently screws or pushes it in to perform initial, controlled dilation of the soft tissue along the path, creating space for the subsequent insertion of the larger diameter working cannula 410 and reducing tissue resistance.

[0076] The working sleeve 410 is then fitted over the expansion sleeve 420 and slid in along it until it reaches the preset depth. At this point, the working sleeve 410 can be securely connected to the guide rail 100. Finally, the expansion sleeve 420 can be removed.

[0077] In another embodiment, the working component 400 may also be directly composed of the working sleeve 410, which is directly installed on the guide rail 100 after the bone removal component 300 is removed.

[0078] According to one embodiment of the present invention, the working assembly 400 includes a set of expansion sleeves 420 with increasing diameters, the expansion sleeves 420 being used for progressively expanding soft tissue.

[0079] Reference Figure 18 Guided by the guide rail 100, the surgeon first inserts the initial dilatation cannula 420 with the smallest diameter to perform preliminary dilatation of the soft tissue along the path; then, the surgeon replaces the dilatation cannula 420 with larger diameter cannulas 420 along the guide rail 100 in turn to achieve gradual and gentle dilatation of the soft tissue until the channel size that matches the working cannula 410 is reached.

[0080] Understandably, the dilating cannula 420 can gradually expand the soft tissue, thereby protecting it and avoiding iatrogenic damage. For example, in one embodiment, a level 1 dilating cannula is inserted along the guide rail, a level 2 dilating cannula is inserted along the level 1 dilating cannula, a level 3 dilating cannula is inserted along the level 2 dilating cannula, and finally, after installing the working cannula 410, the dilating cannulas are removed. The next surgical procedure is then performed in the established working channel.

[0081] The working sleeve 410 is then fitted over the largest expansion sleeve 420 and slid in until it reaches the preset depth. At this point, the working sleeve 410 can also be securely connected to the guide rail 100 via its connecting part. Finally, all expansion sleeves 420 can be removed in sequence.

[0082] The working cannula 410 can have various different structures to accommodate the application of subsequent medical devices on the working cannula 410. For details, please refer to... Figure 15 , Figure 16 and Figure 17 ,in Figure 15 An example is shown in the assembly structure diagram of the guide rail and the hollow working sleeve. Figure 16 A schematic diagram illustrating the assembly structure of the guide rail and the semi-open working sleeve is provided. Figure 17 An example of the assembly structure of the guide rail and the closed working sleeve is shown in the diagram.

[0083] Of course, the working sleeve 410 can also adopt other structures, such as Figures 19 to 23 .

[0084] According to one embodiment of the present invention, the working assembly 400 includes an endoscope, and the working channel includes an instrument channel 411 and an endoscope channel 412, which are parallel and independent of each other, with the endoscope passing through the endoscope channel 412. The working assembly 400 also includes a bone graft device adapted to be implanted into an interbody fusion cage through the instrument channel.

[0085] Existing technical solutions generally lack a dedicated mechanism for integrated, physical isolation and protection of the exit nerve root and the walking nerve root, resulting in a high potential risk of damage to the nerve structures during instrument operation.

[0086] It should be noted that the endoscope and bone graft devices can work independently or together.

[0087] According to one embodiment of the present invention, the guide rail 100 is provided with an isolation structure 110, which is used to isolate the exit nerve root.

[0088] In one embodiment, the isolation structure 110 is a tongue-shaped flap structure, used to push open and isolate the exit nerve root during the insertion of the guide rail 100 along the initial positioning path.

[0089] In some embodiments, the guide rail 100 includes a mating part 120, which is versatile and can mate with both the guide pin 200 and the guide 310.

[0090] In one embodiment, refer to Figures 6 to 12 The mating part 120 is provided with a mating groove 121 and a first through hole 122. The first through hole 122 is located at the end of the mating groove 121, and the guide pin 200 is adapted to pass through the first through hole 122 to achieve mating. The guide 310 is provided with a mating block 311 corresponding to the mating groove 121. The mating groove 121 and the mating block 311 are mated and connected. The end of the mating block 311 is provided with a first connecting post 312, which is adapted to mate with the first through hole 122.

[0091] In one embodiment, the guide rail 100 includes a second through hole 140, and the guide 310 is provided with a second connecting post 313 corresponding to the second through hole 140, and the second through hole 140 and the second connecting post 313 are connected in a cooperative manner.

[0092] In some embodiments, the guide rail 100 is provided with a mounting portion 130, and the working sleeve 410 is provided with an assembly portion 413 corresponding to the mounting portion 130. The mounting portion 130 is used to cooperate and connect with the assembly portion 413 to achieve stable cooperation. In one embodiment, the mounting portion 130 is a U-shaped groove, and the assembly portion is a U-shaped slider.

[0093] In one embodiment, the mounting portions 130 are symmetrically arranged on both sides of the guide rail 101, achieving a stable connection.

[0094] In one embodiment, the guide rail 100 is provided with a handle, and further, the handle is a hollow handle.

[0095] The guiding component of this invention integrates multiple steps—puncture positioning, bone window creation, channel formation, and nerve protection—into a coherent and controllable process through the core guide rail 100. Its core solution principle is as follows: Using the initially inserted guide needle 200, an ideal three-dimensional path from the body surface through the superior articular process to the intervertebral space is determined in one go with the aid of a limited number of fluoroscopic examinations. Subsequently, the guide rail 100 slides along the guide needle 200 and replaces the guide needle 200, becoming a fixed and immovable path reference, fundamentally avoiding path deviation and loss in subsequent operations.

[0096] The guide rail 100 not only defines the path but also physically isolates the nerve root from the working channel after insertion, providing initial passive safety protection. All subsequent instruments, including the bone removal component 300 and the working component 400, are connected to the guide rail 100 via a standard connection method, ensuring that every expansion, bone removal, and channel creation step is strictly performed along this single reference axis. This achieves stable force transmission and precise control of the operation, preventing path loss.

[0097] Each functional component adopts a modular design. The guide 310 and the guide rail 100 are coupled through precise channels, transforming the "linear" guidance of the guide needle 200 into a stable "tubular" guidance. The U-shaped bone chisel 320 or the elliptical bone chisel 320 can be sequentially driven in along this guide channel to efficiently and accurately remove bone from the superior articular process, forming a bone window. The perforated working sleeve 410 is finally fitted with the sliding baffle to construct a stable and visible working channel that extends from the body surface to the intervertebral space.

[0098] Through the progressive design of "guide needle 200 for positioning, guide rail 100 for guiding, module connection, and cannula formation," the highly experience-dependent steps of traditional surgery, such as puncture, dilation, fenestration, and channel establishment, are integrated into a mechanical, repeatable, and precise assembly process. This not only significantly reduces operational uncertainty and the risk of nerve damage but also makes surgical techniques easier to standardize and learn.

[0099] In summary, the guide component of this invention, through its integrated and progressive design, systematically solves the problems of accuracy, stability, safety, and efficiency in establishing a working channel in the translumbar approach.

[0100] One embodiment of the present invention also provides an operation method for a guide assembly via the supra-lumbar articular approach, referring to... Figure 24 as well as Figures 1 to 3 The operation method includes track setting step 100, guide step 200, window opening step 300, and track formation step 400.

[0101] Tracking step 100: Insert the guide needle 200 into the puncture point to establish an initial positioning path to the intervertebral space. The puncture point on the body surface can be determined under image guidance. Insert the guide needle 200 through the puncture point and advance it towards the target intervertebral space at a preset angle to establish a precise initial positioning path to the intervertebral space.

[0102] Step 200: Slide the guide rail 100 along the guide needle 200, inserting the guide rail 100 along the initial positioning path until it reaches the intervertebral space. Place the hollow guide rail 100 over the guide needle 200 and slide it along it, guiding the guide rail 100 along the initial positioning path until its distal opening securely reaches the predetermined depth within the target intervertebral space. During this process, the guide rail 100 protects the surrounding soft tissue and enhances the stability of the path.

[0103] Windowing step 300: Remove the guide pin 200, connect the bone removal component 300 to the guide rail 100, and operate the bone removal component 300 along the guide rail 101 of the guide rail 100 to remove the bone formation window of the superior articular approach.

[0104] Step 400: Remove the bone removal component 300 and connect the working sleeve 410 to the guide rail 100 to form a stable working channel at the bone window. The working sleeve 410 constructs a protected, stable, direct working channel between the body surface and the surgical target point for subsequent instrument passage and surgical operations.

[0105] The operation method of the guide component via the supra-lumbar articular approach provided in this embodiment of the invention constructs a standardized, modular, and highly integrated channel establishment method. After the initial path is established, the path is immediately protected by the guide rail 100 to avoid secondary damage to soft tissues. Subsequent bone removal and instrument operation are strictly performed under the constraints of the guide rail 100 or the working sleeve 410, precisely limiting the surgical impact to the target bone window area, effectively protecting important tissues such as nerves and blood vessels around the channel, and significantly reducing the risk of iatrogenic injury.

[0106] Furthermore, the system enables the sequential and seamless use of instruments such as the guide needle 200, guide rail 100, bone removal component 300, and working cannula 410. Each instrument has a specific function, compatible interfaces, and smooth operation. For example, guide rail 100 can be reused as a guiding reference for subsequent fenestration and tract creation, avoiding repeated positioning during surgery, shortening the tract establishment time, and thus improving the overall efficiency of the surgery.

[0107] The final working channel not only directly reaches the target point but is also stable and protected. This provides a visualized, highly operable, and minimally disruptive working space for subsequent critical procedures such as discectomy and bone grafting. It addresses the shortcomings of existing technologies, such as high radiation exposure for both surgeons and patients during the working channel establishment process, and the ease with which the correct path can be deviated from or even lost.

[0108] According to one embodiment of the present invention, the bone removal assembly 300 includes a guide 310 and a bone chisel 320, and the fenestration step includes: The guide 310 is inserted into the guide rail 101; The bone chisel 320 is moved along the guide channel of the guide 310 to remove bone.

[0109] Understandably, the guide 310 features a guiding channel to further enhance the working axis and provide precise tubular guidance for subsequent bone resection. Different sized bone chisels 320 can be sequentially inserted into the guiding channel and, under fluoroscopic or endoscopic monitoring, precisely and controllably remove bone from the superior articular process, creating a bone window. All bone removal operations are strictly confined within the preset path, ensuring a stable surgical procedure.

[0110] According to one embodiment of the present invention, moving the bone chisel 320 along the guide channel of the guide 310 to remove bone includes: A set of bone chisels 320 with increasing diameters are used sequentially along the guide channel to gradually enlarge the bone window.

[0111] Understandably, employing a series of bone chisels 320 with increasing diameters sequentially along the same guide channel allows for gradual and controllable expansion of the bone window, significantly improving the precision and safety of the fenestration process. Firstly, the progressive enlargement from fine to coarse facilitates real-time assessment and fine-tuning of the needle insertion angle and bone removal volume during the procedure, avoiding bone splitting or accidental damage that might occur with a single procedure. Secondly, the progressive expansion ensures a regular shape and neat edges of the bone window, creating favorable conditions for the stable insertion of the subsequent working cannula 410, while maximizing the protection of important nerve and vascular structures around the articular processes. This approach enhances the controllability and adaptability of the surgery, helps reduce surgical risks, and improves overall operational efficiency.

[0112] According to one embodiment of the present invention, connecting the working sleeve 410 to the guide rail 100 includes: Connect the expansion sleeve 420 to the guide rail 100 to expand the soft tissue; The working sleeve 410 is fitted onto the outside of the expansion sleeve 420. After the installation is secure, the expansion sleeve 420 is removed.

[0113] Understandably, pre-expansion of the soft tissue by the dilator 420 before insertion of the working cannula 410 can effectively avoid potential damage caused by direct forced insertion of the working cannula 410. The working cannula 410 is fitted over the pre-positioned dilator 420, providing good axial guidance and radial support during the final insertion process. This ensures accurate positioning of the working cannula 410, allowing it to be inserted in one go, and to fit tightly against the surrounding tissue, preventing displacement.

[0114] According to one embodiment of the present invention, connecting the expansion sleeve 420 to the guide rail 100 to expand soft tissue includes: A set of expansion sleeves 420 with increasing diameters are sequentially connected to the guide rail 100 to expand the soft tissue step by step.

[0115] Understandably, the gradual and gentle mechanical dilation of the puncture path through a sequence of cannulas, from thin to thick, allows soft tissues such as muscles and fascia to adapt step by step. Each dilation step serves as an independent assessment point, allowing the surgeon to observe tissue resistance and patient response in real time when changing cannulas, thus enabling precise control and fine-tuning of the dilation degree. Furthermore, the channel formed by the progressive dilation has a smooth inner wall, good compliance, and matches the size gradient of the final working cannula 410. This ensures minimal resistance during the insertion of the working cannula 410 and allows it to fit tightly against surrounding tissues, resulting in an extremely stable working channel and effectively preventing intraoperative displacement of the working cannula 410.

[0116] According to one embodiment of the present invention, after the formation step, the method further includes: Step 500: Insert surgical instruments through the working channel and perform at least one of the following procedures: discectomy, endplate treatment, bone grafting, or interbody fusion implantation.

[0117] It should be noted that surgical instruments include at least one of the following: endoscopes and bone grafting devices.

[0118] According to an embodiment of the present invention, the working cannula 410 is provided with an endoscope channel 412 and an instrument channel 411 parallel to the guide rail 101. The instrument channel 411 and the endoscope channel 412 are independent of each other, and the execution steps include: The endoscope is placed in the endoscope channel 412 for endoscopic operation; Place the bone graft device in instrument channel 411 to perform the bone grafting operation.

[0119] Understandably, the independent endoscopic access channel 412 provides a continuous, stable, and clear direct view of the surgical area. The surgeon can monitor the instrument position, tissue morphology, and operational effects in real time under the endoscope. This fully visualized and precise operation greatly improves the accuracy and controllability of key steps such as discectomy, endplate treatment, and bone grafting.

[0120] The endoscope and surgical instruments have independent, parallel dedicated channels, allowing them to work simultaneously without interference. This avoids operational interruptions caused by repeatedly inserting and removing instruments during the procedure to change or adjust the viewing angle, enabling simultaneous "observation-operation," significantly optimizing the surgical process and shortening the core surgical time.

[0121] It should be noted that the two operations of placing the endoscope in the endoscope channel 412 for endoscopic operation and placing the bone graft device in the instrument channel 411 for bone graft operation can be performed simultaneously or independently; no specific restrictions are imposed here.

[0122] According to one embodiment of the present invention, prior to the orbit determination step, the following steps are included: Location procedure: Locate the puncture point by the intersection of the surface projection of the longitudinal line of the outer edge of the superior articular process and the superior endplate line.

[0123] Understandably, completing precise surface positioning before formally inserting the guide needle 200 ensures a high success rate for the subsequent orbital positioning step 100, avoiding repeated adjustments and re-punctures due to improper puncture points, thereby shortening the preoperative preparation time and improving the overall surgical efficiency.

[0124] To enable those skilled in the art to better understand how the components of this invention work together and how to systematically solve the problems of the prior art, the following example illustrates the specific process of performing endoscopic transarticular interbody fusion using this guiding component, using a patient with lumbar disc herniation and segmental instability in the L4 / L5 segment as an example.

[0125] Preoperative preparation and positioning: After general anesthesia, the patient is placed in the standard prone position. Intraoperative fluoroscopy is performed using a C-arm X-ray machine to confirm the surface projection of the target L4 / L5 intervertebral space and the lateral edge of the L5 superior articular process in anteroposterior and lateral views.

[0126] Intraoperative application steps: Step 1: Orbit Determination The surgeon marks the puncture point on the body surface, located at the intersection of the projections of the longitudinal line of the outer edge of the L5 superior articular process and the line of the L5 superior endplate. Then, a 2.0 mm diameter Kirschner wire is used as the guide wire 200, inserted at this point with an abduction angle of approximately 35°. Under real-time monitoring with lateral fluoroscopy, the needle tip is advanced medially and anteriorly, closely following the lateral bony surface of the L5 superior articular process, ultimately entering approximately 12 mm into the L4 / L5 intervertebral space parallel to and closely following the L5 superior endplate. The ideal position of the guide wire 200 is confirmed by anteroposterior and lateral fluoroscopy. This step, using the guide wire 200, establishes a precise three-dimensional path from the skin to the intervertebral space in a single procedure, significantly reducing the number of fluoroscopic adjustments required by traditional methods.

[0127] Step Two: Guardian Make a longitudinal skin incision approximately 15mm long, centered on the puncture point. Then, slowly insert the guide rail 100 along the already inserted guide needle 200, maintaining the same angle as the guide needle 200. The surgeon can feel it sliding in close to the bone surface until its distal end reaches the predetermined depth within the intervertebral space, and confirm the position again with fluoroscopy. At this point, the nerve protection plate (i.e., the tongue-shaped flap) integrated at the distal end of the guide rail 100 has physically isolated the L4 exit nerve root outside the working area, achieving continuous nerve protection from the beginning of the channel establishment.

[0128] Step 3: Determine the axis The guide needle 200 is withdrawn. At this point, the guide rail 100 has become a stable channel reference. The surgeon inserts the guide 310 from the bone removal assembly 300 along the guide rail 101 of the guide rail 100, wedging its tip into the superior articular process bone. This operation completes the conversion from the “linear” guide needle 200 to a “tubular” rigid guide channel, providing an immovable axis for subsequent bone removal operations.

[0129] Step 4: Open the window Guided by the guide 310, the surgeon sequentially uses bone chisels 320 with outer diameters of 3mm, 5mm, and 7mm (a U-shaped bone chisel 320 can be used in this embodiment) fitted over the guide 310 and gently taps. The bone chisels 320 strictly follow the predetermined path, gradually enlarging to precisely remove part of the bone and annulus fibrosus on the ventral side of the L5 superior articular process, forming a bone window. Throughout the bone removal process, because all instruments are doubly constrained by the guide rail 100 and the guide 310, the operation feels solid, with no path drift, ensuring the accuracy of the bone window position.

[0130] Step Five: Attaining Enlightenment After the bone window is formed, all bone chisels 320 and guides 310 are removed sequentially. Then, an expansion cannula 420 is inserted first to gently expand the soft tissue, followed by the insertion of the final working cannula 410. The proximal end of the working cannula 410 is securely connected to the locking structure at the proximal end of the guide rail 100, forming a stable composite working channel extending from the body surface to the intervertebral space. Finally, the expansion cannula 420 is removed.

[0131] Step Six: Endoscopic Surgical Procedure An endoscopic system is inserted through this established working channel. The endoscopic view is clear, revealing the nerve root well-protected by the nerve protection plate of guide rail 100 and the opened bone window. Within this stable and protected channel, the surgeon can comfortably perform subsequent procedures such as discectomy, endplate treatment, bone grafting, and interbody fusion cage implantation. Finally, internal fixation can be completed using a percutaneous pedicle screw system.

[0132] As can be seen from the above clinical applications, the guiding component of the present invention successfully and systematically overcomes the main technical defects of existing surgical approaches pointed out in the background art: This device effectively overcomes the drawbacks of "low operational precision and over-reliance on fluoroscopy and surgeon's experience": The guide needle 200 is precisely positioned and fixed along the path of the guide rail 100 in a single operation, ensuring that all subsequent instruments are introduced along this uniquely defined path via physical coupling. This significantly reduces the number of fluoroscopy sessions required to confirm instrument placement at each step from 10-15 in traditional methods to only 2-3 for initial positioning and final confirmation, significantly reducing radiation exposure for both doctors and patients. Simultaneously, the standardized operating procedure reduces the absolute dependence on the surgeon's personal experience and spatial reasoning abilities, making the technology easier to master and promote.

[0133] This component fundamentally solves the shortcomings of "easy loss of working path and unstable channel": it creates a continuous rigid mechanical guide chain from the guide needle 200, guide rail 100 to the working cannula 410. Instruments are reliably connected through locking mechanisms and sliding grooves, completely avoiding the risk of path loss due to soft tissue retraction or operational deviations when changing guidewires or exchanging multi-stage dilatation tubes, as is common in traditional methods. The established final working channel is exceptionally stable, providing a stable and clear field of vision for delicate endoscopic operations, ensuring surgical quality.

[0134] This design significantly improves upon the shortcomings of passive and high-risk neuroprotection mechanisms: the guide rail 100 of this component integrates a neuroprotection plate at its distal end, which is placed in a critical position at the earliest stage of channel establishment, achieving physical isolation of critical structures such as the exit nerve root. Subsequently, all larger-diameter or more invasive instruments are operated from inside the "protective umbrella" of the guide rail 100. This design transforms the neuroprotection strategy from the traditional "dynamic avoidance during surgery" to "initial static isolation," greatly enhancing the safety baseline of the surgery.

[0135] This kit successfully addresses the shortcomings of "cumbersome surgical procedures and low overall efficiency": through modular design, it integrates multiple previously discrete and sequential steps, such as puncture, soft tissue expansion, nerve protection, bone window preparation, and working channel establishment, into a coherent "assembly-style" streamlined operation. The number of instrument exchanges is significantly reduced, and the transitions between steps are smooth. Clinical practice shows that using this kit can shorten the time to establish a stable working channel by approximately 30%-50%, thereby significantly reducing overall surgical time and improving operating room turnover efficiency.

[0136] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A guide assembly for a translumbar supra-articular approach, characterized in that, include: The guide rail is equipped with a guide track; A guide needle is slidably inserted through the guide rail to establish an initial positioning path to the intervertebral space, the initial positioning path being parallel to the guide rail; the guide rail is adapted to move along the initial positioning path. A bone removal assembly is detachably connected to the guide rail to remove bone formation windows in the upper articular approach. A working component includes a working sleeve adapted to connect with the guide rail to form a working channel after the bone removal component has been removed.

2. The guide assembly for the translumbar supra-articular approach according to claim 1, characterized in that, The bone removal component includes: A guide, which passes through the guide rail and has a guide channel; A bone chisel, adapted to move along the guide channel to remove bone-forming windows in the superior articular approach.

3. The guide assembly for the translumbar supra-articular approach according to claim 2, characterized in that, The bone removal assembly includes a set of bone chisels with increasing diameters, which are used to progressively enlarge the bone window.

4. The guide assembly for the translumbar supra-articular approach according to claim 1, characterized in that, The working components include: An expansion cannula, adapted to be connected to the guide rail after the bone removal assembly has been removed, the expansion cannula being used to expand soft tissue, and a working cannula being fitted over the expansion cannula.

5. The guide assembly for the translumbar supra-articular approach according to claim 4, characterized in that, The working assembly includes a set of expansion sleeves with increasing diameters, which are used to progressively expand the soft tissue; And / or, the working components include an endoscope and a bone graft device, the working channel includes an instrument channel and an endoscope channel, the instrument channel and the endoscope channel are parallel, and the endoscope passes through the endoscope channel; the bone graft device is adapted to be implanted into an interbody fusion device through the instrument channel; And / or, the guide rail is provided with an isolation structure for isolating the exit nerve root.

6. A method for operating a guide assembly via the supra-lumbar articular approach, characterized in that, Includes the following steps: Track setting procedure: Insert the guide needle into the puncture point to establish an initial positioning path to the intervertebral space; Guided procedure: Slide the guide rail along the guide needle to insert the guide rail along the initial positioning path until it reaches the intervertebral space; Windowing procedure: Remove the guide pin, connect the bone removal assembly to the guide rail, and operate the bone removal assembly along the guide rail to remove the bone formation window in the upper joint approach. Procedure: Remove the bone removal assembly and connect the working sleeve to the guide rail to form a stable working channel at the bone window.

7. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 6, characterized in that, The bone removal assembly includes a guide and a bone chisel, and the fenestration step includes: The guide is inserted into the guide rail; The bone chisel is moved along the guide channel of the guide to remove bone.

8. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 7, characterized in that, Moving the bone chisel along the guide channel of the guide to remove bone includes: A set of bone chisels with increasing diameters are used sequentially along the guide channel to gradually enlarge the bone window.

9. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 6, characterized in that, The connection of the working sleeve to the guide rail includes: Connect the expansion cannula to the guide rail to expand the soft tissue; The working sleeve is placed over the expansion sleeve, and after it is securely installed, the expansion sleeve is removed.

10. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 9, characterized in that, Connecting the expansion sleeve to the guide rail to expand soft tissue includes: A set of expansion sleeves with increasing diameters are sequentially connected to the guide rail to expand the soft tissue step by step.

11. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 6, characterized in that, Following the path-establishment step, the following is also included: Execution steps: Insert surgical instruments through the working channel to perform at least one of the following procedures: discectomy, endplate treatment, bone grafting, or interbody fusion implantation.

12. The method of operating the guide assembly via the supra-lumbar articular approach according to claim 11, characterized in that, The working cannula has an endoscope channel and an instrument channel parallel to the guide rail. The instrument channel and the endoscope channel are independent of each other. The execution steps include: Place the endoscope in the endoscope channel to perform endoscopic procedures; The bone graft device is placed in the instrument channel for bone grafting.

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