TW201836557A - Method of guiding spinal surgical tool - Google Patents

Abstract

The present invention discloses a spinal surgical tool and a method of guiding thereof. The spinal surgical tool is operated with a precedent device. The precedent device includes at least a guiding member. The spinal surgical tool includes an operation part, an extension part, a handling part and a guided part. One end of the extension part connects to the operation part. The other end of the extension part connects to the handling part. The guided part is disposed on the extension part and includes at least one guided hole. The operation part is guided to approach the precedent device by passing the guided hole through the guiding member.

Description

Method of guiding a spinal surgery tool

The present invention relates to a surgical tool and a method of guiding a surgical tool, and more particularly to a spinal surgery tool and a method of guiding a spinal surgery tool.

The spine is one of the most important parts of the body's ability to determine the activity of the human body. When the spinal cord occurs, especially in the lumbar region, it tends to have a considerable impact on the patient, including pain and numbness. Feelings of powerlessness, even incontinence or difficulty. The above symptoms are caused by the translocation between the vertebral bodies, which causes the nerves or spinal cord to be compressed, and the clinical diagnosis can be divided into disc herniation, spondylolisthesis, spinal stenosis or degenerative spine due to different causes. Side bends, etc. When the symptoms are severe, the patient often cannot correct the discomfort by correcting, but must rely on the spinal surgery for the reduction treatment. As for how to effectively fix the vertebral body after the reduction to avoid the relocation, it is the key to the success of the treatment.

The most stable and widely used treatment currently is the use of the Pedicle screw fixation system. The pedicle screw internal fixator system can be used for spinal fusion surgery such as vertebral fixation and reduction after conventional discectomy, cervical degeneration treatment and scoliosis correction. During the procedure, the operator must operate a variety of different surgical tools to erect the pedicle screw internal fixator system to the desired vertebral section, and each operation must first locate the component that has been implanted first. The location, such as the pedicle screw, and the precise movement of the different surgical tools to the site, the effectiveness and efficiency of the procedure is the key to the success or failure of the surgery, as well as the speed of recovery.

The pedicle screw internal fixator system has a plurality of vertebral arch screws, taking a multi-axial vertebral arch screw as an example. Each vertebral arch screw can be roughly divided into a screw shaft (Screw shaft), a connector (Tulip) and an inner cover (again It is called the limit ring and the Retainer ring. It is also equipped with a locking screw (also called Nut, Nut). The common pedicle screw internal fixator system is used for spinal surgery. The vertebral arch screws are inserted into the vertebral body from the vertebral arches on both sides of the spine, and the connecting rod (Rod) is adjusted to meet the requirements. After the spine curve, the locking screw and the anti-torque wrench are used to lock the locking screw together with the connecting rod in the connecting seat to complete the restoration or stabilization of the front and rear vertebral bodies. If necessary during the operation, the operator will adjust the angle of the pedicle screw with a pedicle screw adjuster.

When operating the above surgical tools, the operator must extend from the patient into the wound and move to the position of the pedicle screw one by one, but it is difficult to locate the muscle ligament tissue after the pedicle screw implantation, so during the operation It is often necessary to peel or open the muscle ligament attached to the spine, even to open up and even remove more of the vertebrae. The problem associated with this method is not only the increase in blood loss, but also the anatomical damage that causes slower recovery of the wound, more serious postoperative pain, and higher postoperative infection rate, which leads to an increase in hospital stays. The increase in medical expenses.

However, in addition to the pedicle screw internal fixator system, other spinal surgery often requires large and frequent use of different surgical tools, such as for the treatment of spinal stenosis, mild spondylolisthesis or adjacent segmental disc disease. Fusion surgery. Compared with the pedicle screw internal fixator system, non-fusion fixed surgery can allow the spine to maintain more angles of movement and reduce the early degeneration of adjacent vertebrae, but non-fusion fixation surgery, for example, after implanting the implant Bone graft or Bone cement, or the Cage, is opened, and it is also necessary to position the device that first enters the body and guide the subsequent tools to it. In order to be effective and reduce the damage to complete the surgery.

In recent years, the clinical importance of minimally invasive spinal surgery has been increasing, and it has gradually been favored by surgeons and patients, especially with the newly developed Cortical bone trajectory screw technique and Cortical screw. It is seen as a new treatment direction that may replace traditional surgery.

Minimally invasive spinal surgery is aimed at small wounds, so the recovery is fast, but the space for the operation of the surgical tools in the patient is narrower, and because the human muscles and connective tissue block the sight of the surgical operation, the visibility of the operator to the patient's body. More limited, it is more difficult to position the screw. The above factors make the connection of the connecting rod or the surgical tool and the screw more difficult, which not only causes certain difficulties and pressures on the operator to operate the instrument, but also may prolong the burden on the patient during the operation time, and even the operator usually relies on the touch during the process. Sense to assist in positioning, indirectly affects the willingness of the surgeon to perform minimally invasive surgery.

Therefore, whether it is a traditional or minimally invasive spinal surgery, how to reposition the position of the screw or the spreader (which can be called the advance device) and make the tool move smoothly to it is a very important issue. Moreover, how to reduce the screw positioning of the operator in minimally invasive surgery and the inconvenience of guiding the approaching tool has a very significant impact on improving the proportion of minimally invasive surgery performed.

In view of the above problems, the main object of the present invention is to provide a spinal surgery tool and a method for guiding the same to the prior device. The spinal surgery tool includes an operation portion and a guiding portion, and the guiding portion has a guiding hole, so Can be used with a leading device with a guide. By passing the guiding hole of the spinal surgery tool through the guiding device of the advance device, the spinal surgical tool can be smoothly guided to approach the preceding device, which makes it difficult for the operator to accurately position the preceding device, which makes the operation impossible. The problem with the tool reaching that location.

To achieve the above objects, the present invention provides a spinal surgery tool for use with a preceding device that includes at least one guide. The spinal surgery tool includes an operating portion, an extension, a grip, and a guide. One end of the extension is connected to the operation portion. The grip is connected to the other end of the extension. The guiding portion is disposed on the extension portion, and the guiding portion has at least one guiding hole, and the guiding hole is passed through the guiding member, and the spinal surgery tool is guided to approach the preceding device.

According to an embodiment of the invention, the guiding portion is sleeved on the extension or integrally formed with the extension.

According to an embodiment of the invention, the distance between the guiding portion and the operating portion is shorter than the distance from the grip portion.

According to an embodiment of the invention, the distance between the guiding portion and the operating portion is approximately zero.

According to an embodiment of the invention, the width of the guiding portion near one end of the grip portion is greater than the width near one end of the operating portion.

According to an embodiment of the invention, the guiding portion has a groove located at a periphery of the guiding hole, and the groove communicates with the guiding hole and the external space.

According to an embodiment of the invention, the guiding portion has a blocking piece disposed between the groove and the guiding hole.

According to an embodiment of the invention, the guiding portion has at least two guiding holes, and the two guiding holes are located on opposite sides with the extension of the extension or the extension being the center line.

According to an embodiment of the invention, the operating portion has at least one longitudinal groove, and the spinal surgical tool includes an adjustable member and a rod. The rod member is disposed on the grip portion, the extension portion and the partial operation portion, the rod member is movably connected to the adjustable member, and the other end is received in the operation portion, and the adjustable member is moved to move the rod member in the operation portion when being adjusted. The operating unit is expanded.

According to an embodiment of the invention, the operating portion has an accommodating space, the rod member has an expanding head, and the expanding head is received in the accommodating space, and the outer wall slope of the expanding head is greater than the inner wall slope of the accommodating space.

According to an embodiment of the invention, the distance between the guiding portion and the operating portion is about zero, the guiding portion has a bottom edge and a side wall, the bottom edge is connected to the operating portion, and the side wall portion is connected to the extending portion.

According to an embodiment of the invention, the guide hole extends through the side wall.

According to an embodiment of the invention, the guiding portion has at least two guiding holes, one of which is adjacent to the extending portion and the other adjacent to the operating portion, and the guiding holes are in communication.

According to an embodiment of the invention, the spinal surgery tool is a pre-locking wrench, a pedicle screw adjuster, a connecting rod holder, a bone filling or restorative material syringe, an anti-torque wrench or a breaker.

To achieve the above objects, the present invention further provides a method of guiding a spinal surgery tool to approach a preceding device. The leading device includes at least one guide. The spinal surgery tool includes an operating portion, an extension, a grip, and a guide. One end of the extension portion is connected to the operation portion, the grip portion is connected to the other end of the extension portion, and the guide portion is disposed at the extension portion, and the guide portion has at least one guide hole. The method includes the steps of: passing the guide hole through the guide; and guiding the spinal surgery tool to approach the advancement device.

According to an embodiment of the invention, the guiding method comprises the step of combining the guiding members on the preceding device.

According to an embodiment of the invention, the guiding method comprises the step of moving the guiding hole on the guiding member toward the preceding device to engage the operating portion with the preceding device.

According to the present invention, a spinal surgery tool and a method of guiding a spinal surgery tool according to the present invention are used in conjunction with a preceding device having a guiding member, the spinal surgical tool including an operating portion, an extension portion, and a grip portion. And a guide. The two ends of the extension are respectively connected to the operation portion and the grip portion, and the guide portion is provided at the extension portion. The guiding portion has a guiding hole, and the operator can guide the guiding hole to move on the guiding member by aligning the guiding hole and passing through the guiding member, thereby driving the spine operator to perform directional movement. The operation unit is made to efficiently and efficiently approach the preceding device for subsequent operations. Therefore, it is possible to reduce the problem that the operator encounters limited operation space and obstruction of sight during surgery, and the adverse effects of expanding or peeling off the tissue, which is very helpful for improving the success rate of surgery, reducing the operation time, and accelerating postoperative recovery. beneficial.

In addition, the spinal surgery tool of the present invention may be a pedicle screw internal fixator system or a cortical bone trajectory screw technology, and a plurality of different instruments used in conjunction with the screw, so that even if different surgical instruments need to be replaced multiple times during the spinal surgery, the operator The guiding hole can pass through the guiding member, so that the moving path of the spinal surgery tool can follow the guiding member, thereby being smoothly guided to the screw, or removed from the screw according to the original entering path, thereby reducing the expansion of the wound. .

Especially in minimally invasive surgery, the guide of the advance device can be exposed from the surgical wound to the back of the patient, and the operator can clearly know the position where the advance device is implanted, and can be easily used in the subsequent operation of the surgical tool. Ground discrimination or alignment should enter the direction.

In order to enable the reviewing committee to better understand the technical contents of the present invention, the preferred embodiments are described below.

First, the spinal surgery tool of the present invention is used in conjunction with a prior device for treating, correcting, ameliorating, relieving spinal lesions or avoiding the deterioration of spinal lesions. A specific embodiment is the surgical treatment of a pedicle screw internal fixator system. Wherein, the advance device is a pedicle screw, the number of which may be two-two pairs and a plurality of pairs, such as six or eight; and the spinal surgery tool may be a pre-locking wrench, a pedicle screw adjuster, a connecting rod holding A syringe, bone-filling or restorative material syringe, torsion wrench or breaker, which is a device that is used in various procedures for completing a pedicle screw internal fixator system. Hereinafter, the present invention will be described by taking a pedicle screw internal fixator system as an example, but the present invention is not limited to this application, and other applications such as a cortical bone trajectory screw technique, or an intervertebral or intravertebral cage. (Cage) or Expander (Fusion surgery), or a variety of treatments that first implant a specific device into the spine system and then operate other instruments in conjunction with the device.

1A is a schematic structural view of a preceding device, FIG. 1B is an exploded view of the preceding device shown in FIG. 1A, FIG. 1C is a schematic view of assembling the preceding device shown in FIG. 1A to prepare for implantation, and FIG. 1D is a first embodiment shown in FIG. 1A. Schematic diagram of the device after implantation into the vertebral body, FIG. 1E is a schematic view of the treatment of spinal lesions with a pedicle screw internal fixation system including the prior device shown in FIG. 1A, please refer to FIG. 1A to FIG. 1E. The advance device 9 of this embodiment is a pedicle screw, also known as a pedicle screw. Because of the operation, the surgeon must first insert the pedicle screw into the vertebral body, and then the vertebral screw internal fixation system can be completed by operating various different spinal surgery tools and accessories on the pedicle screw, so the pedicle screw is called A preceding device 9.

In this embodiment, the advancement device 9 includes a shank 91, a coupling seat 92, an inner cover 93, and at least one guide member 94. The connector 92 is generally U-shaped and may be referred to as a U-shaped head or a U-head. An intermediate recess 95 defines a receiving space 95 for receiving the connecting rod 8 and the locking screw 7 for fixing the connecting rod 8. The shank 91 and the connecting seat 92 may be integrally formed, or may be connected by a ball joint as shown in the figure. In the instrument name, the former is a Uniaxial screw, and the latter is a multi-axial or universal joint. Polyaxial screw.

The thread on the shank 91 can be designed differently depending on the implantation position, wherein one of the evenly distributed threads is a pedicle screw implanted by the vertebral arch, and the other is a threaded upper and lower thread. A sparse cortical nail, but the invention is not limited to any one.

The connector 92 can be further divided into a joint 921 and a removable portion 922. Referring to FIG. 1B, when the advancement device 9 is assembled, the shank 91 is first passed through the accommodating space 95, and the diameter of the spherical head of the shank 91 is larger than the inner diameter of the perforation below the accommodating space 95. Therefore, the card is stuck on the lower perforation, and then the inner cover 93 is placed on the spherical head of the shank 91. Finally, the spherical head and the inner cover 93 of the shank 91 are pressed together by the jig. The card is fastened to the joint 921 at the lower perforation. The top edge of the removable portion 922 has an opening 922a corresponding to the number of the guide members 94. In this embodiment, the top edges of the two removable portions 922 respectively have an opening 922a, and the opening 922a is preferably located in the middle of the top edge of the removable portion 922, and has a thread therein, which can pass through the screw lock. Combined with the guide 94. The guide member 94 is a long rod structure having a length of about 7 to 20 cm, preferably 10 to 15 cm, and a diameter of about 0.2 cm or less, preferably 0.1 to 0.2 cm. The guide member 94 can be made of various biocompatible and rigid materials, such as titanium alloy. In addition, the advancement device 9 of the present invention may have one guiding member 94, but preferably, the advancement device 9 has two guiding members 94 oppositely disposed on the removable portion 922 on both sides of the connecting seat 92. Top edge. The two guiding members 94 further have the effect of assisting the operator to judge the orientation of the connecting seat 92, and further facilitate the smooth engagement of the operating portion 11 with the connecting seat 92, which is a conventional K-wire or K-wire. Unable to provide the effect.

In general, most patients who require vertebral screw internal fixation system surgery are Lumbar lesions, usually located in the lumbar vertebrae L4, L5. The operator uses an open-circuit drill (Awl) and other instruments to enter from the insertion point on the lumbar vertebrae, and pass through the pedicle to reach the cancellous bone of the vertebral body to form a nail passage. The operator can then choose whether to expand or tap the access channel to facilitate screw placement. Referring to FIG. 1C, after the preparation of the nail passage is completed, the two guiding members 94 are screwed into the opening 922a of the top edge of the removable portion 922, and the thread on the inner side of the connecting seat 92 and the outer side of the Screwdriver 6 are used. The threaded engagement screwes the front end of the screwdriver 6 into the accommodating space 95 of the connecting seat 92, and the front end of the screwdriver 6 has a structure that cooperates with the groove at the upper end of the head of the shank 91, for example, a hexagonal structure, so the screwdriver is used. After the front end structure of the 6 is passed through the inner cover 93 and snapped into the head of the shank 91, the preparation of the advance device 9 is completed, and the shank 91 can be directly rotated by the screwdriver 6. For the sake of simplicity, Figure 1C shows only the portion of the screwdriver 6 that is coupled to the advancement device 9. Next, the operator holds the screwdriver 6 to apply force to implant the advance device 9 into the vertebral body. As a result, as shown in Fig. 1D, the implantation of the four preceding devices 9 is completed. However, it should be noted that, in order to simplify the drawing, FIG. 1D shows only one guide 94 on one side of the preceding device 9.

As shown in Fig. 1D, after the advancement device 9 is implanted, the guide member 94 extends from the vertebral body about 3 to 8 cm outside the patient's back, preferably 4 to 5 cm, so that the operator can not only visually follow the guide. The piece 94 quickly locates the approximate implantation position and implantation trajectory of the advancement device 9 without the need to re-find. In addition, the portion of the guide member 94 that protrudes beyond the back of the patient can serve as an indicator for facilitating the directional use of the spinal surgery tool after the operator. In other embodiments of the present invention, the guiding member 94 may be provided with marking elements, such as color or mark marks, to facilitate the operator to distinguish the guiding members on the same preceding device or the guiding members on different preceding devices. .

The guide 94 not only indicates the position of the advancement device 9, but more importantly provides the function of guiding the spinal surgery tool. The spinal surgery tool of the present invention has a guiding portion through which the guiding hole can pass through the guiding member 94 on the advancement device 9, so that the spinal surgical tool can be guided to follow the guiding member 94 to move toward the preceding device 9. .

2 is a schematic view of a first embodiment of a spinal surgery tool of the present invention, as shown in FIG. 2. In the present embodiment, the spinal surgery tool 1 is a pedicle screw adjuster. The spinal surgery tool 1 includes an operation portion 11, an extension portion 12, a grip portion 13, and a guide portion 14. One end of the extension portion 12 is connected to the operation portion 11 , and the other end is connected to the grip portion 13 , that is, the opposite ends of the extension portion 12 are the operation portion 11 and the grip portion 13 , respectively. The operation portion 11 refers to a portion that is actually used to provide different functions required during surgery during spinal surgery, and the corresponding functional requirements have different configurations. In the vertebral screw adjuster of the embodiment, the operating portion 11 has a configuration that cooperates with the accommodating space 95 of the connecting seat 92, and is engageable in the connecting seat 92, so that the operator can extend the portion 12 as an axis. The heart rotates the grip portion 13 clockwise or counterclockwise, thereby rotating the connecting seat 92 to adjust the orientation of the U-shaped recess, so that the connecting rod 8 can be smoothly caught in the accommodating space 95.

The extension portion 12 has a long rod shape, and can maintain the distance between the operation portion 11 and the grip portion 13, thereby ensuring that the force application position (the grip portion 13) does not fall into the patient body, and the convenience of the operation is maintained, and the operation can be increased. The length of the arm is labor-saving. In order to make the operation more efficient and effective, preferably, the operating portion 11 and the extension portion 12 may be integrally formed, but may be replaced by a connection such as tight joint, snapping or screwing.

The grip portion 13 provides a position for the operator to grip, and controls the operation portion 11 by gripping and applying force to the grip portion 13. Similarly, the configuration of the corresponding grip portion 13 of the different types of spinal surgery tools 1 is also different. The grip portion 13 and the extension portion 12 of the present embodiment are perpendicular to each other or nearly perpendicular, so that the operator can rotate the grip portion 13 with the extension portion 12 as an axis.

The guide portion 14 is provided at a position on the extension portion 12 close to the operation portion 11. The guiding portion 14 has at least one guiding hole 141, preferably two guiding holes 141. Each of the guide holes 141 has two openings which are disposed opposite to each other with the direction perpendicular to the extension 12 as a center line C. In the operation, the operator refers to the guide 94 that exposes the outside of the patient's back, as shown in FIG. 1D, aligns the spinal surgery tool 1 in the proper orientation, and then passes the guiding hole 141 through the guiding member 94 to make the guiding hole. The 141 can move down the guide 94. Since the guiding portion 14 is fixed to the extension portion 12, this action can drive the entire spinal surgery tool 1 to move directionally (following the guiding member 94), so that the operating portion 11 can approach the preceding device 9 under guidance. To achieve the purpose of guiding positioning (refer to FIG. 5F and FIG. 5G first). Furthermore, the guiding portion 14 is located behind the operating portion 11, and the distance between the two is different depending on the function of the spinal surgery tool 1, so that the guiding portion 14 does not enter the connecting seat 92 or the connecting seat. The 92 sets are connected so that the design complexity of the leading device 9 and/or the guiding portion 14 is not increased. After the adjustment is completed, the vertebral surgical tool 1 can also be removed in a directional manner according to the guiding member 94 to avoid expanding the wound or damaging the surrounding tissue.

3 is an enlarged schematic view of the guiding portion shown in FIG. 2, and the guiding member 94 passes through one of the guiding holes 141, as shown in FIG. The guiding portion 14 has a fixing hole 142. The extending portion 12 passes through the fixing hole 142 to sleeve and fix the guiding portion 14 to the extending portion 12. Preferably, the distance between the guiding portion 14 and the operating portion 11 is about 4 cm or less, which is shorter than the distance between the guiding portion 14 and the grip portion 13. In other words, the guiding portion 14 is closer to the operating portion 11, and the guiding guide is lowered. The difference in diameter between the lead member 94 and the guide hole 141 causes the guide member 94 to sway in the guide hole 141, so that the influence of the angle between the extension portion 12 and the guide member 94 in the long axis direction is affected. . In addition, the distance between the guiding portion 14 and the operating portion 11 is preferably to achieve a balance between alignment and avoidance of interference with other instruments. Specifically, the closer the distance between the guide portion 14 and the operation portion 11, the easier it is for the operator to align, but when the distance between the two is too close, it is easy to interfere with, for example, the torsion wrench.

The number and arrangement positions of the guide holes 141 preferably match the guide members 94. As shown in FIG. 1A and FIG. 3, the advance device 9 has two opposite guiding members 94. Correspondingly, the guiding portion 14 has two guiding holes 141, and the two guiding holes 141 are fixed to the holes 142. The center line is the center line and is located on the opposite side of the fixing hole 142. Please refer to FIG. 2 , in other words, when the guiding portion 14 is sleeved on the extension portion 12 , the two guiding holes 141 are located on the opposite side of the fixing hole 142 with the extension portion 12 as a center line.

As shown in FIG. 2 and FIG. 3, preferably, the width W1 of the guiding portion 14 near the end of the grip portion 13 is larger than the width W2 near the end of the operating portion 11 to form a trapezoid-like structure and two inclined surfaces 143. One end of the guiding hole 141 is open on the inclined surface 143, and since the inclined surface 143 is located on the side close to the operating portion 11, when the guiding hole 141 is to pass through the guiding member 94, the design of the inclined surface 143 can guide the guiding portion to a certain extent. The guiding member 94 enters the guiding hole 141, and at the same time slightly enlarges the sectional area of the guiding hole 141, both of which can increase the fault-tolerant space between the two, so that the guiding member 94 can easily pass through the guiding hole 141.

4 is a schematic view of a second embodiment of the spinal surgery tool of the present invention, please refer to FIG. 1A, FIG. 1D, FIG. 1E and FIG. The spinal surgery tool 1a of the present embodiment is a connecting rod holder for placing the connecting rod 8 on the connecting seat 92 or adjusting the position of the connecting rod 8. The spinal surgery tool 1a of the present embodiment also includes an operation portion 11a, an extension portion 12a, a grip portion 13a, and a guide portion 14a. The opposite ends of the extension portion 12a are connected to the operation portion 11a and the grip portion 13a, respectively. The guide portion 14a is the same as the first embodiment, and is sleeved on the extension portion 12a, and the distance between the guide portion 14a and the operation portion 11a is shorter than the distance from the grip portion 13a. For the rest of the details, refer to the foregoing embodiment. This is not mentioned here. Among them, the operation portion 11a and the grip portion 13a are different from the first embodiment in accordance with the function of the link lever holder.

The operating portion 11a includes a recess 111a for gripping the connecting rod 8. One end of the groove 111a of the present embodiment is a closed end 112a, and the operation portion 11a is an end end of the connecting rod 8 with the open end of the groove 111a. In other embodiments, the operating portion 11a can remove the closed end 112a such that the recess 111a extends transversely through the operating portion 11a, causing the operating portion 11a to grip any section of the connecting rod 8, in particular the intermediate portion, with the recess 111a. Can improve the stability of holding. Preferably, the recess 111a is provided with a convex portion 113a which can abut against the connecting rod 8 placed in the recess 111a, so that the operating portion 11a can hold the connecting rod 8 more stably.

Moreover, the grip portion 13a of the present embodiment further has a rotating shaft 131a for facilitating the operator to adjust the position of the connecting rod 8. The operator can grasp and guide the holding portion 13a, align the guiding hole 141a with the guiding member 94, and pass the guiding hole 141a through the guiding member 94 so that the operating portion 11a can be In the guiding manner, the connecting seat 92 is smoothly approached, and the connecting rod 8 is placed in the connecting seat 92, thereby eliminating the problem that the operator encounters limited operation space and obstructed vision during the operation, and needs to expand or peel the tissue. Moreover, the left and right opposite guiding members 94 can represent the relative positions of the removable portion 922, and can also be used to infer the opening orientation of the U-shaped recess, indicating the orientation that the connecting rod 8 should be adjusted to assist. The operator completes this step efficiently.

FIG. 5A is a schematic view of a third embodiment of a spinal surgery tool of the present invention, please refer to FIG. 1A, FIG. 1D, FIG. 1E and FIG. 5A. After the connecting rod 8 is placed in the accommodating space 95 of the connecting seat 92, it needs to be locked with the locking screw 7 to the bottom of the accommodating space 95, so as to achieve the effect of merging adjacent vertebral segments. Spinal surgical tools used by the operator during tightening include, but are not limited to, pre-locking wrenches and/or anti-torque wrenches. The spinal surgery tool 1b of the third embodiment is a pre-locking wrench. The spinal surgery tool 1b of the present embodiment also includes an operation portion 11b, an extension portion 12b, a grip portion 13b, and a guide portion 14b. The opposite ends of the extension portion 12b are connected to the operation portion 11b and the grip portion 13b, respectively. The guide portion 14b is the same as the previous embodiment, and is sleeved on the extension portion 12b, and the distance between the guide portion 14b and the operation portion 11b is shorter than the distance from the grip portion 13b. For the rest of the details, reference may be made to the foregoing embodiment. No further explanation. Among them, the operation portion 11b, the extension portion 12b, and the grip portion 13b have a structure different from that of the foregoing embodiment in accordance with the function of the pre-locking wrench.

5B is an exploded perspective view of the spinal surgery tool shown in FIG. 5A, and FIG. 5C is a schematic view of the operation portion shown in FIG. 5A when the locking screw is coupled, as shown in FIG. 5B and FIG. 5C. Specifically, the front end of the operating portion 11b of the present embodiment has an engaging structure 114b that cooperates with the top or inner ring groove of the locking screw 7. The operator uses the engaging structure 114b to snap into the groove, so that the spinal surgery tool 1b is stably coupled with the locking screw 7 to reach the purpose of holding the locking screw 7. The operating portion 11b has at least one longitudinal groove 115b and a receiving space 116b. The longitudinal groove 115b is longitudinally disposed on the side wall of the operating portion 11b and communicates with the internal receiving space 116b and the external space. The spinal surgery tool 1b further includes an adjustable member 15b and a rod member 16b. The adjustable member 15b is adjacent to the grip portion 13b and is located at one end of the grip portion 13b with respect to the extension portion 12b. Each of the grip portion 13b and the extension portion 12b has a through pipe. When the grip portion 13b, the extension portion 12b, and the operation portion 11b are assembled, the accommodating space 116b can communicate with the end of the grip portion 13b. The rod member 16b is disposed in the grip portion 13b, the extension portion 12b, and the partial operation portion 11b, and is housed in the communicating duct and the accommodating space 116b. The other end of the rod member 16b is connected and fixed to the adjustable member 15b. When the adjustable member 15b is turned, the movable rod member 16b can be moved in the operating portion 11b to expand the operating portion 11b.

The operator first snaps the engaging structure 114b into the top end groove of the locking screw 7, as shown in Fig. 5C, and then rotates the adjustable member 15b. When the pipe in the grip portion 13b or the extension portion 12b or the accommodating space 116b in the operation portion 11b is provided with an internal thread, and the rod member 16b is provided with an external thread, the rotation adjustable member 15b can drive the rod member 16b. Rotate and move toward one end of the grip portion 13b. 5D and FIG. 5E, FIG. 5D is a schematic cross-sectional view taken along line A-A of FIG. 5A, and FIG. 5E is a schematic view of the operation when the operation portion shown in FIG. 5D is enlarged. Since the rod member 16b has an expansion head 161b, the expansion head 161b is accommodated in the accommodating space 116b, and the outer wall slope of the expansion head 161b is larger than the inner wall slope of the bottom end of the accommodating space 116b. Therefore, when the rod member 16b is moved in the direction of the grip portion 13b, the expansion head 161b is also retracted in the same direction, so that an outwardly expanding force is applied to the inner wall of the accommodating space 116b as shown in Fig. 5E. Since the longitudinal groove 115b is formed in the side wall of the operation portion 11b, the side wall of the operation portion 11b has an outwardly expanding elasticity, and the degree of outward expansion of the operation portion 11b is more remarkable. Therefore, the engaging structure 114b and the locking screw 7 can be more closely matched, so that the combination of the spinal surgery tool 1b and the locking screw 7 can be more stable, and the locking screw 7 is lowered during the movement due to collision with the surrounding tissue. The opportunity to fall.

5F and FIG. 5G are schematic diagrams showing the operation of the spinal surgery tool shown in FIG. 5A, which is shown in conjunction with FIG. 5F and FIG. 5G. According to the foregoing, the operator approaches the spinal surgery tool 1b stably coupled with the locking screw 7 close to the guiding member 94, and then aligns the guiding member 94 and passes through the guiding hole 141b so that the operating portion 11b is guided. The lower portion is adjacent to the connecting seat 92, thereby smoothly locking the locking screw 7 downward into the connecting seat 92 while pressing the connecting rod 8 to the positioning. After the fixing of the connecting rod 8 is completed, the operator reversely rotates the adjustable member 15b to move the expanding head 161b in the direction of the operating portion 11b, returning the side wall of the operating portion 11b to its original shape, and releasing the engagement with the locking screw 7. In other embodiments of the present invention, the side wall of the operating portion 11b is outwardly expanded when the expansion head 161b is moved in the direction of the operating portion 11b, and the side wall is moved to the original position in the direction of the grip portion 13b. .

It should be noted that the guiding portions 14, 14a, and 14b of the above embodiment are similar to a trapezoidal structure, as shown in the first embodiment, and are sleeved on the extension portion 12. However, the present invention does not limit the guiding. The outer shape of the portion 14 can also be as shown in Figs. 6A and 6B. 6A and 6B are schematic views showing another variation of the guiding portion shown in Fig. 3. Referring to FIG. 2 and FIG. 6A , the guiding portion 24 has a groove 242 at the periphery of the guiding hole 241 , and the guiding hole 241 and the external space are communicated by the groove 242 . The groove 242 is disposed so that the operator can bring the groove 242 of the guiding portion 24 closer to the guiding member 94, so that the guiding member 94 is inserted into the guiding hole 241 via the groove 242, thereby guiding the guiding hole 241 through the guiding. Item 94.

Preferably, the guiding portion 24 further has a blocking piece 243 disposed between the groove 242 and the guiding hole 241 and located on one side of the groove 242. When the operator approaches the groove 242 of the guiding portion 24 and contacts the guiding member 94, the blocking piece 243 is bent or expanded, so that the guiding member 94 can be smoothly inserted into the guiding hole 241. When the guide member 94 is fitted, the stopper piece 243 is returned to the original shape, thereby restricting the guide member 94 from being guided into the guide hole 241 without being easily detached. In practice, the flap 243 may preferably be a thin metal or metal sheet having the property of being easily bent or rebounded.

In other embodiments, as shown in FIG. 6B, the blocking piece 243a of the guiding portion 24a may also be a soft material. Moreover, the baffle 243a of the soft material may be located on both sides of the groove 242a. When the guide member 94 contacts the stopper piece 243a, the stopper piece 243a is compressed so that the guide member 94 is fitted into the guide hole 241a and passes through the guide hole 241a. After the guiding member 94 is inserted into the guiding hole 241a, the blocking piece 243a returns to its original state.

7 is a schematic view of a fourth embodiment of a spinal surgery tool of the present invention, please refer to FIG. 1A, FIG. 1D, FIG. 1E and FIG. The spinal surgery tool 1c of the present embodiment is an anti-torque wrench, and includes an operation portion 11c, an extension portion 12c, a grip portion 13c, and a guiding portion 14c. The two ends of the extension portion 12c are respectively connected to the operation portion 11c and the grip portion 13c. The guiding portion 14c is provided in the extension portion 12c. The configuration of the operation portion 11c, the extension portion 12c, and the guide portion 14c is slightly different from the foregoing embodiment in order to respond to the function of the torsion wrench.

The bottom of the operating portion 11c has a plurality of pins for fixing corresponding locking ends, such as the outer side of the connecting seat 92, to counter the torque generated on the connecting seat 92 when the locking screw 7 is locked, and the connecting seat 92 is prevented from following. Rotate to lock the locking screw 7 or to prevent the screw from loosening. The operation portion 11c is a columnar hollow structure and can cover the connecting seat 92. The upper opening allows the operation portion 11b of the other spinal surgery tool 1b (pre-locking wrench) to enter the operation, for example, the locking screw 7 is fixed to fix the connecting rod. 8.

In the present embodiment, the extension portion 12c is connected to a part of the side wall of the operation portion 11c, and the distance between the guide portion 14c and the operation portion 11c is about zero. In other words, the guiding portion 14c can be directly connected to the operating portion 11c and the extending portion 12c. Specifically, the configuration of the guiding portion 14c corresponds to the operating portion 11c, which is an annular hollow structure, and the guiding portion 14c has a bottom edge 144c and a side wall 145c, and the bottom edge 144c is connected to the operating portion 11c, and the side wall 145c The extension portion 12c is partially connected. Preferably, the operating portion 11c, the extension portion 12c and the guiding portion 14c of the embodiment are of an integral structure, and the guiding hole 141c penetrates the side wall 145c so that the guiding hole 141c can pass through the guiding member 94.

The operator can first pass the guiding hole 141c of the guiding portion 14c of the present embodiment through the guiding member 94 so that the operating portion 11c approaches and encloses the connecting seat 92. Next, the locking screw 7 is taken by the spinal surgery tool 1b (pre-locking wrench) of the third embodiment, and the operating portion 11b and the locking screw 7 are guided together into the connecting seat 92 to be screwed. The operator grasps the spinal surgery tool 1b (pre-locking wrench) in one hand to lock the locking screw 7 and press the connecting rod 8 down, and the other hand applies the spinal surgery tool 1c (anti-torque wrench) to stabilize the connecting seat 92 to avoid A rotation occurs.

8 is a schematic view of a fifth embodiment of the spinal surgery tool of the present invention, please refer to FIG. 1A, FIG. 1D, FIG. 1E and FIG. The spinal surgery tool 1d of the fifth embodiment is a bone filling or restorative material syringe which can be applied to a spinal surgery in which bone cement, artificial bone or other repair material is to be filled. It should be noted that the nail rod 91 used in the spinal surgery tool 1d of the present embodiment is a nail rod 91 having a feeding channel (not shown). After the advance device 9 is implanted, the spinal surgery tool 1d can be used. Bone cement or other restorative material is injected into the vertebrae.

The spinal surgery tool 1d includes an operation portion 11d, an extension portion 12d, a grip portion 13d, and a guide portion 14d. The two ends of the extension portion 12d are respectively connected to the operation portion 11d and the grip portion 13d, and the guide portion 14d is provided on the extension portion 12d. The guide portion 14d of the present embodiment is sleeved on the extension portion 12d, and the guide portion 14d is directly sleeved on one end of the extension portion 12d connecting the operation portion 11d, so that the distance between the guide portion 14d and the operation portion 11d is about zero. . The operation portion 11d of the embodiment includes an injection head 117d, and the inside of the extension portion 12d can directly accommodate artificial bone, bone cement or other repair material, or accommodate artificial bone, Syringe for bone cement or other restorative materials. The spinal surgery tool 1d is provided with a pushing function structure behind the grip portion 13d, for example, a rotating pusher column 132d. The rotating pusher column 132d includes a pusher knob 133d and an inner pusher column, and the pusher knob 133d has an upper and lower limit ring and a limit space formed therebetween. The outer side of the inner pusher column has an outwardly extending positioning ring, which is accommodated in the limiting space, so that when the pusher knob 133d is rotated, only the inner pusher is pushed forward to move forward, but the inner pusher column is not driven. Rotate, so as to avoid the kinetic decrease of the syringe plunger due to the gradual hardening of the injection material, but it is subject to the torque due to the contact of the inner push column, and finally the plastic material can not withstand the fracture or break due to the excessive accumulated torque, resulting in an injection. Serious problem that was forced to interrupt.

Similarly, the operator can pass the guiding hole 141d through the guiding member 94 to guide the operating portion 11d to approach the connecting seat 92. Thereafter, the external thread 118d on the operation portion 11d is engaged with the screw thread on the inner side of the coupling seat 92 to stably couple the two, and the injection head 117d is inserted into the injection passage in the nail rod 91. Next, the push knob 133d is rotated to push the inner pusher column, and then push the pusher of the syringe to inject artificial bone, bone cement or other repair material into the vertebral body or other bone tissue.

9A is a schematic view of a sixth embodiment of a spinal surgery tool of the present invention, as shown in FIGS. 1A, 1D, 1E, and 9A. The connector seat 92 has a removable portion 922, and the aforementioned guide member 94 is disposed on the upper edge of the removable portion 922. When the fixing of the connecting rod 8 is completed, the operator needs to remove the removable portion 922 by means of a breaker, and the spinal surgery tool 1e of the present embodiment is a breaker. The spinal surgery tool 1e of the present embodiment also includes an operation portion 11e, an extension portion 12e, a grip portion 13e, and a guide portion 14e, and the two ends of the extension portion 12e are connected to the operation portion 11e and the grip portion 13e, respectively.

FIG. 9B is an internal schematic view of the operation portion shown in FIG. 9A, which is shown in conjunction with FIG. 9B. The operating portion 11e of the present embodiment has an accommodating space 119e having a shape that cooperates with the removable portion 922 to fit over the removable portion 922 of the connecting seat 92. In the present embodiment, the guiding portion 14e includes two guiding holes 141e, 141f that communicate with each other. Specifically, one of the guiding holes 141e is adjacent to the extending portion 12e, and the other guiding hole 141f is adjacent to the operating portion 11e and located at the upper end of the accommodating space 119e.

The operator can approach the operating portion 11e to the guiding member 94 on one side of the connecting seat 92, and then pass the guiding member 94 through the guiding hole 141f at the upper end of the accommodating space 119e, and pass through the guiding hole 141e from the other guiding hole 141e. Out, as indicated by the arrow symbol in Figure 9A. Thereby, the accommodating space 119e of the guiding operation portion 11e is smoothly fitted over the removable portion 922, and even the removable portion 922 can be accurately inserted into the accommodating space 119e. Then, the operator can apply force to the grip portion 13e, and the removable portion 922 is folded outward. After the removable portion 922 is broken, the spine surgical tool 1e and the broken movable can be removed according to the same guiding path. Division 922.

It should be noted that, in any embodiment of the present invention, the specific description of the structure, the size, the material, and the like, except that the spine surgical tool technology has different parts in essence due to different functions, the other is not particularly limited to This embodiment can be extended to other embodiments for reference, in particular to the description of the guiding portion.

In addition, the present invention further provides a method of guiding a spinal surgery tool to approach a preceding device. The preceding device can refer to the preceding device 9 of the previous embodiment, which includes at least one guide. The spinal surgery tool includes an operating portion, an extension, a grip, and a guide. One end of the extension portion is connected to the operation portion, the grip portion is connected to the other end of the extension portion, and the guide portion is disposed at the extension portion, and the guide portion has at least one guide hole. For the structural features of the components and their connection relationship, reference may be made to any of the spinal surgery tools 1, 1a, 1b, 1c, 1d, and 1e of the foregoing embodiments, and no further details are provided herein.

10 is a schematic flow chart of an embodiment of a method for guiding a spinal surgery tool to approach a preceding device according to the present invention. Please refer to FIG. The method of this embodiment is a method for an operator to operate a spinal surgery tool, comprising the steps of: first combining a guiding member on a preceding device (step S10); placing the preceding device in a patient, and causing the guiding member to at least Part of the patient is exposed outside the body (step S20); the guide hole is passed through the guide (step S30); and the spinal surgery tool is guided to approach the advance device (step S40). The step S10 is related to the assembly of the preceding device and its guiding member. For details, refer to the description of FIG. 1A and FIG. 1B. The method and tool for placing the advance device in the patient in step S20 can be referred to the description of FIG. 1C described above, and the result of at least partially exposing the guide member to the outside of the patient can be referred to FIG. 1D. With regard to step S30 and step S40, the guiding hole passes through the guiding member, and the operation of guiding the spinal surgery tool to approach the advance device can refer to the action relationship between the spinal surgery tool and the preceding device of the first to sixth embodiments. . As shown in FIG. 5C, FIG. 5F and FIG. 5G, when the guiding hole 141b passes through the guiding member 94, the spinal surgery tool 1b can be further guided to approach the advance device 9, and specifically, the guiding hole 141b can be made The guide member 94 is moved toward the connecting seat 92 of the advance device 9, and the operating portion 11b is further brought close to the connecting seat 92. For other types of surgical tools, such as pedicle screw adjusters, bone filler or repair material syringes, torsion wrenches or breakers, the operating portion can also be combined with the components of the preceding device.

In summary, the spinal surgery tool and the method for guiding the spinal surgery tool according to the present invention are used in conjunction with a preceding device having a guiding member, the spinal surgical tool including an operating portion, an extension portion, and a grip portion. And a guide. The two ends of the extension are respectively connected to the operation portion and the grip portion, and the guide portion is provided at the extension portion. The guiding portion has a guiding hole, and the operator can guide the guiding hole to move on the guiding member by aligning the guiding hole and passing through the guiding member, thereby driving the spine operator to perform directional movement. The operation unit is made to efficiently and efficiently approach the preceding device for subsequent operations. Therefore, it is possible to reduce the problem that the operator encounters limited operation space and obstruction of sight during surgery, and the adverse effects of expanding or peeling off the tissue, which is very helpful for improving the success rate of surgery, reducing the operation time, and accelerating postoperative recovery. beneficial.

In addition, the spinal surgery tool of the present invention may be a pedicle screw internal fixator system or a cortical bone trajectory screw technology, and a plurality of different instruments used in conjunction with the screw, so that even if different surgical instruments need to be replaced multiple times during the spinal surgery, the operator The guiding hole can pass through the guiding member, so that the moving path of the spinal surgery tool can follow the guiding member, thereby being smoothly guided to the screw, or the original entering path can be removed from the screw to reduce the wound. expand.

Especially in minimally invasive surgery, the guide of the advance device can be exposed from the surgical wound to the back of the patient, and the operator can clearly know the position where the advance device is implanted, and can be easily used in the subsequent operation of the surgical tool. Ground discrimination or alignment should enter the direction.

Regardless of the purpose, means and efficacy of the present invention, it is shown that it is different from the characteristics of the prior art, and the reviewing committee is required to express the patent and grant the patent as soon as possible. It should be noted that the above-described embodiments are exemplified for the convenience of the description, and the scope of the claims is intended to be limited to the above embodiments.

1, 1a, 1b, 1c, 1d, 1e‧‧‧ spinal surgery tools

11, 11a, 11b, 11c, 11d, 11e‧‧‧ Operation Department

111a‧‧‧ Groove

112a‧‧‧closed end

113a‧‧‧ convex

114b‧‧‧Snap structure

115b‧‧‧Longitudinal groove

116b, 119e‧‧‧ accommodating space

117d‧‧‧Injection head

118d‧‧‧ external thread

12, 12a, 12b, 12c, 12d, 12e‧ ‧ extensions

13, 13a, 13b, 13c, 13d, 13e‧‧‧ grip

131a‧‧‧ shaft

132d‧‧‧Rotary push column

133d‧‧‧ push knob

14, 14a, 14b, 14c, 14d, 14e, 24, 24a ‧ ‧ guidance

Guide holes 141, 141a, 141b, 141c, 141d, 141e, 141f, 241, 241a‧‧

142‧‧‧Fixed holes

143‧‧‧Bevel

144c‧‧‧ bottom edge

145c‧‧‧ side wall

15b‧‧‧Adjustable parts

16b‧‧‧ rods

161b‧‧‧Expansion head

242, 242a‧‧‧ trench

243, 243a‧‧ ‧ sheets

6‧‧‧ Screwdriver

7‧‧‧Locking screws

8‧‧‧ Connecting rod

9‧‧‧First device

91‧‧‧nail rod

92‧‧‧Connecting Block

921‧‧‧ joint seat

922‧‧‧Removable Department

922a‧‧‧Opening

93‧‧‧ inner cover

94‧‧‧Guide

95‧‧‧ accommodating space

C‧‧‧ center line

S10 ~ S40‧‧‧ steps

W1‧‧‧Width

W2‧‧‧Width

Fig. 1A is a schematic structural view of a preceding device. FIG. 1B is an exploded perspective view of the preceding device shown in FIG. 1A. Figure 1C is a schematic illustration of the assembly of the advancement device of Figure 1A to prepare for implantation. FIG. 1D is a schematic view of the advance device shown in FIG. 1A after implantation into a vertebral body. Figure 1E is a schematic illustration of the treatment of spinal lesions with a pedicle screw internal fixation system including the prior device shown in Figure 1A. 2 is a schematic view of a first embodiment of a spinal surgery tool of the present invention. Fig. 3 is an enlarged schematic view showing the guide portion shown in Fig. 2. 4 is a schematic view of a second embodiment of a spinal surgery tool of the present invention. Figure 5A is a schematic illustration of a third embodiment of a spinal surgery tool of the present invention. Figure 5B is an exploded perspective view of the spinal surgery tool of Figure 5A. FIG. 5C is a schematic view of the operation portion shown in FIG. 5A when the locking screw is coupled. Fig. 5D is a schematic cross-sectional view taken along line A-A of Fig. 5A. Fig. 5E is a schematic view showing the operation of the operation portion shown in Fig. 5D when it is enlarged. 5F and 5G are schematic views showing the operation of the spinal surgery tool shown in Fig. 5A. 6A and 6B are schematic views showing another variation of the guiding portion shown in Fig. 3. Figure 7 is a schematic illustration of a fourth embodiment of a spinal surgery tool of the present invention. Figure 8 is a schematic illustration of a fifth embodiment of a spinal surgery tool of the present invention. 9A is a schematic view of a sixth embodiment of a spinal surgery tool of the present invention. Fig. 9B is a schematic internal view of the operation portion shown in Fig. 9A. 10 is a flow chart showing an embodiment of a method for guiding a spinal surgery tool to approach a preceding device of the present invention.

Claims (14)

A method of guiding a spinal surgery tool to a proximity device, the advance device comprising at least one guiding member, the spinal surgical tool comprising an operating portion, an extension portion, a grip portion and a guiding portion, the extension portion One end is connected to the operating portion, and the holding portion is connected to the other end of the extending portion. The guiding portion is disposed on the extending portion, the guiding portion has at least one guiding hole, and the method comprises the following steps: A guide hole passes through the guide; and the spinal surgery tool is guided to approach the advance device. The method of claim 1, further comprising the step of: combining the guiding member on the preceding device. The method of claim 2, wherein the guide member is combined with the advance device prior to implantation of the advance device. The method of claim 1, further comprising the step of: moving the guiding hole to the leading device on the guiding member to combine the operating portion with the preceding device. The method of claim 1, wherein the two sides of the guiding portion respectively have a slope, the method further comprising the steps of: guiding the guiding member into the guiding hole by the inclined surface, and The guide hole passes through the guide. The method of claim 4, wherein a width of the guiding portion near an end of the grip portion is greater than a width near an end of the operating portion. The method of claim 1, wherein the guiding portion has a groove, wherein the step of passing the guiding hole through the guiding member further comprises: the groove of the guiding portion is adjacent to the groove a guiding member; and the guiding member is embedded in the guiding hole via the groove. The method of claim 7, wherein the groove is located at a periphery of the guiding hole, and the groove communicates with the guiding hole and the external space. The method of claim 7, wherein the guiding portion has a blocking piece, wherein the step of passing the guiding hole through the guiding member further comprises: when the groove of the guiding portion is close to When the guide member is bent or expanded through the flap, the guide member is inserted into the guide hole. The method of claim 1, wherein the advance device further comprises a connecting member, the guiding member being combined with a top edge of the connecting seat, when the operating portion is coupled with the connecting seat of the preceding device The guiding portion is not connected to the connecting seat. The method of claim 10, wherein the guiding portion of the spinal surgery tool is sleeved on the extension, the method further comprising the steps of: guiding the guiding hole on the guiding member The device moves to cause the operating portion to enter the docking station. The method of claim 10, wherein the guiding portion of the spinal surgery tool has a bottom edge and a side wall, the bottom edge connecting the operating portion, the side wall portion connecting the extending portion, and the guiding The hole extends through the side wall, and the method further comprises the step of: moving the guiding hole to the leading device on the guiding member, so that the operating portion approaches and covers the connecting seat. The method of claim 10, wherein the connecting seat further has at least one removable portion, the guiding portion of the spinal surgical tool having at least two guiding holes, one of which is adjacent to the extending portion, The other is adjacent to the operating portion, and the guiding holes are connected to each other. The method further comprises the steps of: approaching the guiding member with the guiding hole adjacent to the operating portion, so that the guiding member is adjacent to the operating portion The guiding hole penetrates and passes through the guiding hole adjacent to the extending portion; and the guiding hole moves on the guiding member to the preceding device, so that the operating portion is sleeved on the connecting seat Removable part. The method of claim 1, further comprising the step of: arranging a marking element on the guiding member.