阅读说明：本技术 以两个不同扭矩水平拧紧骨科固定螺钉的系统 (System for tightening orthopaedic fixation screws with two different torque levels ) 是由 V·勒福科尼耶 于 2020-03-26 设计创作，主要内容包括：一种骨科植入物套件,用于将固定螺钉拧紧到椎弓根螺钉的头部以用于将脊柱杆保持到椎弓根螺钉,套件包括：用于保持椎弓根螺钉的头部的螺钉延长器,用于与所述固定螺钉接合以将固定螺钉螺纹地拧紧到椎弓根螺钉的头部的固定螺钉起子,用于将固定螺钉起子和螺钉延长器之间的扭矩限制为第一扭矩值的第一扭矩限制机构或用于指示已达到第一扭矩的第一扭矩指示机构,以及用于将固定螺钉起子和螺钉延长器之间的扭矩限制为第二扭矩值的第二扭矩限制机构,第二扭矩值高于第一扭矩值。(An orthopedic implant kit for tightening a set screw to a head of a pedicle screw for retaining a spinal rod to the pedicle screw, the kit comprising: a screw extender for retaining a head of a pedicle screw, a set screw driver for engaging the set screw to threadedly tighten the set screw to the head of the pedicle screw, a first torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a first torque value or a first torque indicating mechanism for indicating that the first torque has been reached, and a second torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a second torque value, the second torque value being higher than the first torque value.)

1. An orthopedic implant kit for tightening a fixation screw to a head of a pedicle screw, the kit comprising:

a screw extender for holding a head of the pedicle screw;

a set screw driver for engaging the set screw to threadedly tighten the set screw relative to the head of the pedicle screw;

a first torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a first torque value or a first torque indicating mechanism for indicating that the first torque value has been reached between the set screw driver and the screw extender; and

a second torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a second torque value, the second torque value being higher than the first torque value.

2. The orthopedic implant kit of claim 1, wherein the first torque limiting mechanism or the first torque indicating mechanism and the second torque limiting mechanism are integrated into the set screw driver.

3. The orthopedic implant kit of claim 1, further comprising:

a handle for rotating the set screw driver relative to the screw extender, the first torque limiting mechanism or the first torque indicating mechanism being disposed between the handle and the set screw driver, and the second torque limiting mechanism being integrated into the set screw driver.

4. The orthopedic implant kit of claim 1, further comprising:

a handle for rotating the set screw driver relative to the screw extender, the first torque limiting mechanism or the first torque indicating mechanism configured to be disposed between the handle and the set screw driver, and the second torque limiting mechanism configured to be disposed between the handle and the set screw driver.

5. The orthopedic implant kit of claim 2, wherein the fixation screwdriver comprises:

a shaft having a set screw engaging portion;

a tubular member surrounding the shaft; and

an outer housing surrounding the tubular element, the outer housing having external threads for threadingly engaging the internal threads of the screw extender,

wherein a first frangible pin is disposed between the tubular element and the outer housing forming part of the first torque limiting mechanism or the first torque indicating mechanism and a second frangible pin is disposed between the tubular element and the shaft forming the second torque limiting mechanism.

6. The orthopedic implant kit of claim 5, wherein the fixation screwdriver further comprises:

a mechanism for generating at least one of vibration or sound when the first frangible pin that is part of the first torque indicating mechanism breaks.

7. The orthopedic implant kit of claim 6, wherein the mechanism comprises a protrusion that engages a recessed portion of a sidewall of the tubular element.

8. The orthopedic implant kit of claim 4, wherein the fixation screwdriver further comprises:

a bolt for preventing rotational movement between the tubular element and the outer housing after the first frangible pin is broken.

9. The orthopedic implant kit of claim 1, wherein the first torque indicating mechanism comprises at least one of: a torque scale, a mechanism that produces a vibration when the first torque value is exceeded, a mechanism that produces a jolt when the first torque value is exceeded, and a mechanism that produces an audible sound when the first torque value is exceeded.

10. A method for tightening a set screw to a head of a pedicle screw for retaining a spinal rod, the head of the pedicle screw having a groove that receives the spinal rod, the method comprising the steps of:

threadedly engaging a fixation screw to a head of the pedicle screw;

attaching a set screw driver to the set screw;

tightening the set screw a first time to the head of the pedicle screw and the spinal rod with a first torque limited by a first torque limiting mechanism associated with the set screw driver or by a first torque indicating mechanism for indicating that the first torque has been reached; and

tightening the set screw a second time to the head of the pedicle screw and the spinal rod with a second torque higher than the first torque, the second torque limited by a second torque limiting mechanism associated with the set screw driver.

11. The method for tightening a set screw of claim 10, wherein the first and second torque limiting mechanisms act between the set screw driver and the head of the pedicle screw to which the screw extender is removably attached in the steps of first and second tightening.

12. The method for tightening a set screw of claim 10, wherein the first torque level is such that the spinal rod cannot be rotated inside the groove by manual operation while maintaining polyaxiality of the pedicle screw.

13. A fixation screwdriver for an orthopedic implant kit having a screw extender for tightening a fixation screw to a head of a pedicle screw, the fixation screwdriver comprising:

a first torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a first torque value or a first torque indicating mechanism for indicating that the first torque value has been reached between the set screw driver and the screw extender; and

a second torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a second torque value, the second torque value being higher than the first torque value.

14. A set screw driver according to claim 13, further comprising:

a shaft having a set screw engaging portion;

a tubular member surrounding the shaft; and

an outer housing surrounding the tubular element,

wherein a first frangible pin or ratchet-type device is disposed between the tubular element and the outer housing forming part of the first torque limiting mechanism or the first torque indicating mechanism, and a second frangible pin is disposed between the tubular element and the shaft forming the second torque limiting mechanism.

15. A set screw driver according to claim 14, wherein the set screw driver further comprises:

a bolt for preventing rotational movement between the tubular element and the outer housing after the frangible pin is broken or the ratchet-type device is released.

16. A set screw driver according to claim 13, wherein the first torque indicating mechanism comprises at least one of: a mechanism that generates vibration when the first torque value is exceeded, a mechanism that generates wobble when the first torque value is exceeded, and a mechanism that generates an audible sound when the first torque value is exceeded.

Technical Field

The present invention relates to orthopaedics, and more precisely, to an orthopaedic tool and system comprising a pedicle screw, a rod and a corresponding fixation screw. The invention also relates to instruments for manipulating these elements, and methods of using these elements to apply torque to a set screw.

Background

In the field of orthopedics and implantation tools and systems for orthopedic surgery, and more particularly for spinal fusion surgery of the spine, set screws are used to push down and attach rod-type or rod-type devices to the head of pedicle screws. The process of pushing the spinal rod down into the pedicle screw head is also referred to as rod reduction. Prior to attaching the rod to the head of the pedicle screw, the pedicle screw is attached to the vertebra using a bone anchor, threaded bone engaging portion, or bone screw for securing the pedicle screw to the vertebra of the patient or living being. To this end, as an example, for several adjacent vertebrae for vertebral fusion, pedicle screws are attached thereto for each vertebra and thereafter a row of pedicle screws is formed along the spinal column by mechanically fastening several pedicle screws towards each other using rods placed in grooves or U-shaped openings formed by the pedicle screw heads. This allows for providing the mechanical support required for spinal stabilization for spinal fusion of a patient or organism.

For example, U.S. patent No. 10,058,355 (which reference is incorporated herein by reference in its entirety) describes an orthopedic implant kit providing pedicle screws, corresponding fixation screws, rods, and tools for manipulating these, including a screw extender for holding the pedicle screws, and a fixation screw driver for threadedly tightening the fixation screws relative to the screw heads of the pedicle screws. As another example, U.S. patent No. 8,795,283 (which reference is incorporated herein by reference in its entirety) describes another type of orthopaedic surgical system kit for spinal stabilization surgical intervention, including pedicle screws having heads for receiving rods, and tools required for surgical intervention. In yet another example, U.S. patent No. 8,262,662 (the reference being incorporated by reference herein in its entirety) provides a system and method for delivering a spinal connector to a spinal anchor site in the spinal column. In one embodiment, a spinal implant and access device are provided that include a U-shaped receiver member, a bone engaging member, an extension member, a spinal rod, and a set screw.

As noted above, similar orthopedic spinal surgery concepts, tools and devices have been proposed for attaching rods to pedicle screws by set screws, such as U.S. patent No. 5,129,388, U.S. patent No. 5,520,689, U.S. patent No. 5,536,268, U.S. patent No. 5,720,751, U.S. patent No. 5,984,923, U.S. patent No. 6,056,753, U.S. patent No. 6,183,472, U.S. patent No. 6,258,090, U.S. patent No. 6,454,768, U.S. patent No. 6,648,888, U.S. patent No. 6,740,086, U.S. patent No. 7,618,442, U.S. patent No. 8,308,782, U.S. patent No. 8,876,868, U.S. patent publication No. 2006/0025771, and U.S. patent publication No. 2018/0289397, all of which are incorporated herein by reference in their entirety.

However, when a surgeon or operator of a spinal surgical tool needs to attach a rod to a pedicle screw via a fixation screw, the prior art tools still present certain problems, particularly in order to find the appropriate amount of torque that needs to be applied to the fixation screw under different circumstances. Thus, while all solutions are currently proposed in the related spinal surgical tools of the prior art, there is a strong desire for significantly improved methods, systems, and devices for spinal surgery.

Disclosure of Invention

According to one aspect of the invention, a method is provided for tightening a set screw to a head of a pedicle screw for retaining a spinal rod, the head of the pedicle screw having a groove for receiving the spinal rod. Preferably, the method comprises the steps of: threadably engaging a set screw to a head of the pedicle screw, attaching a set screw driver to the set screw, tightening the set screw a first time with a first torque to the head of the pedicle screw and the spinal rod, the first torque being limited by a first torque limiting mechanism associated with the set screw driver or by a first torque indicating mechanism for indicating that the first torque has been reached, and tightening the set screw a second time to the head of the pedicle screw and the spinal rod with a second torque higher than the first torque, the second torque being limited by a second torque limiting mechanism associated with the set screw driver.

According to another aspect of the present invention, an orthopedic implant kit for tightening a set screw to a head of a pedicle screw for retaining a spinal rod to the pedicle screw is provided. Preferably, the orthopedic implant kit includes a screw extender for holding a head of the pedicle screw, a set screw driver for engaging the set screw to threadedly tighten the set screw to the head of the pedicle screw, a handle for rotating the set screw driver relative to the screw extender, a first torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a first torque value, or a first torque indicating mechanism for indicating that the first torque has been reached, and a second torque limiting mechanism for limiting torque between the set screw driver and the screw extender to a second torque value, the second torque value being higher than the first torque value.

The above and other objects, features and advantages of the present invention, and the manner of attaining them, will become more apparent and the invention itself will be best understood by reference to the following description of the drawings, which illustrate some preferred embodiments of the invention.

Drawings

The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention and, together with the general description given above and the detailed description given below, serve to explain the features of the invention.

Fig. 1A-1E show different side views of elements of an orthopedic implant kit 100 having a first torque limiting or indicating feature and a second torque limiting feature, wherein fig. 1A shows a side cross-sectional view of an orthopedic tool kit 100 having a pedicle screw 1, a screw head 2, a set screw or fastener 3, a spinal rod 7, a screw extender 6, a set screw driver 26, a first torque handle 25, and a second anti-torque handle 29, fig. 1B shows the same view of fig. 1A with some cross-sectional views inside the set screw driver 26, the screw extender 6, and the first torque handle 25, fig. 1C shows a handle 125 having a torque indicating mechanism 127 (e.g., torque scale), fig. 1D shows a simple handle 225 with or without a ratchet mechanism, and fig. 1E shows a separate torque limiting mechanism 327, which may be operatively placed between the proximal end of the upper shaft 8 or set screwdriver 26 and the handle 25;

fig. 2A to 2E show different views of the first and second torque limiting features integrated into a set screw driver 226 of the orthopaedic kit 100, wherein fig. 2A shows an exemplary cross-sectional view of the set screw driver 226 having a lower section 220 with a hollow cylindrical or tubular body, an intermediate cylindrical housing 237 and a torque driver 210; fig. 2B shows a first position of the locking bolt 235 with a side view of the intermediate cylindrical housing 237 with the locking bolt 235 and also shows three cross sectional views 1, 2,3 in the direction of the central axis of the bolt 235, the first break pin 227 and the second break pin 228; fig. 2C shows a second position of the locking bolt 235 with a side view of the intermediate cylindrical housing 237 with the locking bolt 235 and also shows three cross sectional views 1, 2,3 in the direction of the central axis of the bolt 235, the first break pin 227 and the second break pin 228; FIGS. 2D and 2E illustrate an alternative embodiment of the bolt 235 engaging the notch, showing a side view of the outer surfaces of the intermediate cylindrical housing 237 and bolt 235;

fig. 3A to 3E show exemplary cross-sectional views of different stages of a method during a spinal stabilization surgery according to another aspect of the invention.

Identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. Further, for illustrative purposes, the images are simplified and may not be drawn to scale.

Detailed Description

According to one embodiment, as exemplarily shown in fig. 1A and 1B, an orthopedic implant kit, instrument kit, tool kit or system 100 is provided that includes a handle 25, a first torque limiting or indicating device 27, a set screw driver 8 that may include a second torque limiting device 28 that may be rotated by the handle 25, a second counter handle 29, a screw extender 6, the second counter handle 29 engaged with the set screw driver 6, a set screw 3, a pedicle screw 1 with a screw head 2 and a bone anchor or threaded portion 4, and a spinal rod 7. In the illustrated variant, the first torque limiting mechanism or device 27 limiting the application of torque to the first torque level T1 is an integral part or is fixed or otherwise operatively connected to a first handle 25, for example a T-shaped handle, for screwing the fixation screw 3 to the head 2 of the pedicle screw 1 via the fixation screw driver 26. The first torque level T1 is the torque applied to the set screw 3 relative to the head 2 of the pedicle screw 1, such as when the set screw 3 is threadedly engaged with the head 2 of the pedicle screw 1, and also by abutting or otherwise securing the spinal rod 7 to the head 2 of the pedicle screw 1. The first handle 25 may have a torque limiting mechanism device 27 that may be removably attached to a set screw driver 26 for tightening the set screw 3, which may serve as a first torque limiting mechanism, such as the handle 25 attached to the end, proximal end of the upper shaft 8, or another portion of the set screw driver 26. Such handles for tightening screws with a torque limiting mechanism 27 are described in U.S. Pat. nos. 2,826,107, 4,244,434, 4,838,264, 5,347,894, 5,746,298, 6,640,674, 7,197,968, 7,938,046, 8,028,608 and 10,034,701, which references are incorporated herein by reference in their entirety. When the fixation screw 3 is tightened relative to the screw head 2, the screw extender 6 or screw head holder is fixed to the screw head 2 of the pedicle screw 1, and the counter-handle 29 is in turn attached to the screw extender 6 for counter-torque purposes.

It is important and depends on the particular circumstances during an orthopedic surgical procedure that an appropriate amount of torque be applied to the set screw 3 tightened against the spinal rod 7 retained by the head 2 of the pedicle screw 1. Furthermore, the tightening angle of the fixation screw 3 is also an important aspect, which can translate into a greater torque, which can then be transmitted to the surrounding tissue, thereby causing screw loosening, implant breakage and/or risk of adjacent segment disease. This embodiment describes a solution to the fact that the user, operator or surgeon needs to apply different levels of torque during the procedure and provides a mechanism that significantly simplifies the task. See, for example, the following publications: chapman et al, "factors affecting the pullout strength of cancellous screws", journal of biomechanical engineering, ASME, vol.118, 391-: should one avoid? "," journal of the spine, "vo.13, No.11, pp.1617-1626, 2013, which references are incorporated herein by reference in their entirety.

In a variation, as shown in fig. 1C, rather than a mechanism 27 physically limiting the torque that may be applied to the set screw 3, a first handle 125 having a torque indicating mechanism 127 may be used, but some type of indication is made that the first torque level T1 has been reached, such as, but not limited to, visual, tactile, vibratory, mechanical, audible sounds, such as a rattle or beep, or combinations thereof, or other types of feedback that a user or operator may see, hear, or feel, or any combination of these features. This may be done with or without any means of actually limiting the physical torque applied to the set screw 3. For example, a first handle 125 may be used that incorporates a torque measuring mechanism associated with a torque indicator, scale or gauge 127. For example, a handle 125, wrench, screwdriver, instrument, key, tool or socket and similar mechanisms based on the operating principles described in U.S. patent nos. 4,664,001, 5,048,381, 5,734,113, 6,196,071, 6,398,552, 6,928,885, 7,806,026, 8,225,679 and D715,611 may be used to tighten the set screw 3 via the set screw driver 26 and simultaneously warn or otherwise indicate to a user or operator that the first torque level T1 has been reached, all of which are incorporated herein by reference in their entirety.

The first torque level T1 may be specifically designed for application to lockable polyaxial screws, such as polyaxial pedicle screws, which may be locked by pressure induced by tightening of spinal rod 7 via set screw 3, as exemplarily shown in U.S. patent No. 5,882,350, U.S. patent No. 6,113,601, and U.S. patent No. 6,660,004, which references are incorporated herein by reference in their entirety. Another variation is Medtronic which allows such locking^TMA CD Horizon Solera pedicle screw system having a locking ring or seat that can be pushed against the spherical head of the pedicle screw. In this variation, the first torque level between the set screw 3 and the screw head 2 is such that when tightened to the torque level T1 within the screw head 2 of the pedicle screw 1, the rotational movement of the spinal rod 7 about its own axis is locked, e.g., such that a surgeon, user or operator cannot turn or otherwise rotate the rod 7 within the groove of the screw head. However, at the torque level T1, the pedicle screw 1 still maintains its polyaxial properties because the pressure applied to the upper or lateral surface of the spherical portion of the bone anchor 4 and the locking ring or seat is not sufficient to lock the polyaxial properties. Preferably, the first torque level T1 is approximately in the range between 0.7Nm and 2.1Nm, more preferably about 1.4 Nm.

Next, a second torque limiting mechanism 28 that limits the torque applied to the set screw 3 relative to the head 2 of the pedicle screw 1 to a second torque value or level T2 may be integrated into the set screw driver 26, as shown in U.S. patent No. 10,058,355, which is incorporated by reference in its entirety. For example, as shown in the cross-sectional view of fig. 1B, the set screw driver 26 includes an upper shaft 8, the end of which is engageable with a first handle 25, 125, 225, such as by a different type of mechanical connection, and the lower shaft 20 is hollow for receiving the torque driver 10. The engaging tool 12 of the torque driver 10 may protrude from a lower surface or distal portion of the lower shaft 20 to be engageable with the fixing screw 3 for screw-fastening with respect to the screw head 2, with a screw engaging mechanism 12. The torque driver 10 and the lower shaft 20 are locked relative to each other by a frangible pin 28 traversing at least a portion of the lower shaft 20 and the torque driver 10, forming a second torque limiting mechanism 28 that mechanically limits the amount of torque applied to the set screw 3 via the handle 125 relative to the screw head 2 of the pedicle screw 1 to a second torque level T2. In the shown variant, the torque driver 10 is formed by an internal bolt, rod or shaft which is surrounded at the lower part by a lower shaft 20.

The second torque level T2 is the final torque to be applied to the rod 7 and the screw head 2 via the set screw 3 and is significantly higher than the first torque level. Since the second torque level is the final level to be applied to the set screw 3, the torque limiting mechanism may be irreversible or may be such that a higher torque level cannot be applied to the set screw 3. Preferably, the second torque level T2 is approximately in the range between 8Nm and 12Nm, more preferably approximately 10 Nm.

The set screw driver 26 has an external thread which can be threadedly engaged with the internal thread of the screw extender, having the same pitch as the thread of the set screw. This allows the user or operator to place the set screw 3 onto the forward portion of the torque driver 10 of the set screw driver 26 and then threadingly engage the internal threads of the screw extender 6 to turn or rotate the set screw 3 with the set screw driver 26 down through the screw extender until the set screw 3 contacts and threadingly engages the internal threads of the head 2 of the pedicle screw 1. As the set screw 3 is threadably secured within the head 2 and the set screw driver 26 continues to be rotated or turned by the handle 125, 225, once the anterior face FF of the set screw 3 contacts the spinal rod 7, the torque increases up to the point where the pin 28 breaks. The pin 28 is designed and dimensioned to maintain torque to the second torque level T2 and will break when the second torque level T2 is exceeded. Once the pin 28 is broken, further rotation of the set screw driver 26 therefore no longer affects the rotation and threaded engagement of the set screw 3 within the head 2 of the pedicle screw 1, since the set screw driver 26 will no longer rotate the torque driver 10. In other words, the set screw driver 26 may rotate freely without rotating the torque driver 10. Thus, when the second torque limiting mechanism 28 (in the illustrated variant a frangible pin) is activated or effected, i.e. the second torque level T2 has been reached and the pin 28 is broken, when the user or operator rotates the set screw driver 26 by gripping the handle 125, the set screw driver 26 will be threadedly urged downwardly towards the set screw 3 without rotating the set screw 3. Further, the pedicle screw 1 will gradually be pushed away and released from the screw extender 6. The second handle 29 is removably attached to the screw extender 6 so that a user or operator can tighten the set screw 3 into the head 2 of the pedicle screw 1 with one hand while holding the head 2 of the pedicle screw via the screw extender 6 and the second handle 29. This principle of operation of the second torque limiting mechanism 28 integrated with the set screw driver 26 is also illustrated in fig. 13A-13C, 14 and 15 of U.S. patent No. 10,058,355, which is incorporated herein by reference in its entirety. It is also possible to combine the second torque limiting mechanism with the torque indicating mechanism or not limit the torque to the torque level T2 but only indicate it.

The first torque-limiting mechanism 27 or the first torque-indicating mechanism 127 is preferably designed such that the first torque level T1 is smaller than the second torque level T2 exerted by the second torque-limiting mechanism 28, for example greater than one fifth (by a factor that is bigger that five). This means that in case the first torque limiting mechanism 27 is used with the handle 25, the handle 25 cannot increase the torque that can be applied to the set screw 3 any more once the first torque level is reached. Thus, this requires the user or operator to remove the handle 25 from the set screw driver 26 and replace the handle 25 by placing another handle to the set screw driver 26, such as the handle 25 with a mechanism that limits torque to a second, higher torque level T2, the handle 125 with only the torque indicating mechanism 127 or another type of handle 225 without torque limitation or indication, so that a second, higher level of torque can be applied to the set screw 3 until the second torque level T2 is reached. In the case of using the handle 125, the first torque level T1 and the second torque level T2 can be applied using the same handle, for example by having a scale showing two different torque levels T1 and T2.

As another example, the torque limiting mechanism or device 327 may be a separate device that is not integral with the handle 25, 125, but may be placed between the handle 25 and the set screw driver 26, such as the handle 25 that is not equipped with a different type of torque limiting or indicating mechanism, as shown in FIG. 1E. For example, the torque limiting mechanism 327 or device may be embodied as a proximal end removably connectable to the upper shaft 8 or the set screw driver 26 and the handle 25, 125, for example as a mechanical connecting element having a ratchet-type or bendable lever or protrusion engaged with a recessed portion, and further comprising two interconnecting elements for interconnecting between the handle 25 and the set screw driver 26. In this regard, two different torque limiting mechanisms or devices 327, one for torque level T1 and one for torque level T2, which may thus be visually labeled, may be used in this arrangement. As another variation, the torque limiting or indicating mechanism 27, 127, 327 may be part of or integral to the upper shaft 8 or the proximal end of the set screw driver 26 at the region where the handle 225 is to be connected to the screw extender 6.

In another variation, a torque limiting or torque indicating mechanism that measures or imposes a torque limit may be integrated or connected between the handle 29 and the screw extender 6, or by having one torque limiting or torque indicating mechanism that measures or imposes a torque limit between the handle 29 and the screw extender 6 and one torque limiting or torque indicating mechanism that measures or imposes a torque limit between the handle 25, 125, 225 and the set screw driver 26.

In another variation, as shown in fig. 2A-2C, the first torque indicating mechanism is integrated into the set screw driver 326 along with the second torque limiting mechanism 228 as a break pin. In this variation, the set screw driver 326 comprises a cylindrical hollow region in the lower section 220 that receives the torque driver 210 having the engagement tool 212 at the distal end for engagement with the set screw 3, but also an intermediate cylindrical housing, tube or cylinder 237 located between the lower section 220 of the set screw driver and the torque driver 210. A first torque indicating mechanism is arranged in mechanical cooperation between the torque driver 210 and the intermediate cylindrical housing 237, having a locking bolt 235 engaged with a transverse slot 238, and a first frangible pin 227 traversing both the torque driver 210 and the intermediate cylindrical housing 237. In the first position, rotational or turning movement between the torque driver 210 and the intermediate cylindrical housing 237 is locked by the first break pin 227, limiting the torque that can be applied to the first torque level T1. To this end, the first break pin 227 is sized and designed to break upon application of torque between the torque driver 210 and the intermediate cylindrical housing 237 at a first torque level. In other words, the breaking of the pin 227 may be considered as releasing the first torque holding mechanism embodied by the pin 227. In the second position, rotation between the torque driver 210 and the intermediate cylindrical housing 237 is again locked by the wall 239 of the transverse slot 238.

The first position is shown in fig. 2B with different cross-sectional views 1, 2,3 along the central axis of the set screw driver 326. When a low torque below the first torque level T1 is applied with the set screw driver 326 (e.g., with the handles 125, 225), the locking bolt 235 abuts the side wall 241 of the transverse slot 238 and the first frangible pin 227 has not yet been broken. When the first torque level T1 between the torque driver 210 and the intermediate cylindrical housing 237 is exceeded, the first break pin 227 will break as shown in the cross-sectional view of fig. 4 in fig. 2C. This will produce a mechanical jolt or rattle to the set screw driver 326 that can be felt by the user, and will also produce an audible click or click that can be heard by the user, and can be provided as a signal to the user that the first torque has been reached as a first torque indicating mechanism. Next, the locking bolt 235 will move from contact with the side wall 241 and will move through the transverse slot 238 to abut and be locked again by the other side wall 239 to transition from the first position to the second position by rotating a particular angle defined by the length of the transverse slot 238 between the torque driver 210 and the intermediate cylindrical housing 237, as shown in the three cross-sectional views 4, 5,6 of fig. 2C representing the second position. The locking bolt 235 will then abut against the side wall 241 of the transverse slot 238.

The middle cylindrical housing 237 and the lower section 220 of the set screw driver 326 are still locked together with the second break pin 228 which requires a higher second torque level T2 to break. In this regard, the pin 228 may be considered a second torque-holding mechanism that holds the two elements 237 and 220 together until the second torque level T2 is reached and will release upon reaching the second torque level T2. In this regard, by way of example, one or two (2) or more second break pins 228 are disposed 180 degrees relative to each other to lock rotation of the set screw driver 226 having the lower section 220 relative to the intermediate cylindrical housing 237 until a higher, second torque level T2 is applied. In a variation, there may be several break pins 228. For controlled breakage, it is preferred that there be only one second break pin 228.

Instead of the pins 227, 228, other types of frangible, bendable, releasable, retainable devices may be used which can release the rotational lock between the intermediate cylindrical housing 237 and the set screw driver 326 at the second torque level T2 to form a second torque retaining mechanism when a particular threshold level of torque is applied, or release the rotational lock between the torque driver 210 and the intermediate cylindrical housing 237 at the first torque level T1 to form a first torque retaining mechanism, such as, but not limited to, a frangible plate, a frangible hook, a lever, a ratchet-type fastening element which can be released when a threshold torque is applied, a recessed configuration.

In addition to the breakage of the first frangible pin 227 and the sliding of the bolt within the transverse slot 238 which results in a limited degree of rotation of the torque driver 210 relative to the intermediate cylindrical housing 237, an additional mechanism may be provided to further alert the user, operator or surgeon operating the set screw driver 326 that the first torque level has been reached. In the variant shown, during the transition from the first position to the second position by the locking bolt 235, in other words during the sliding of the bolt 235 from the wall 241 to the wall 239 of the groove 238, the projections 272 to the lower or upper side wall of the transverse groove 238 are made such that the locking bolt 235 passing over these projections 272 will produce a snapping or ratcheting sound and also produce vibrations that can be heard and felt by the user, operator or surgeon. In the variant shown, a plurality of thin longitudinal grooves 271 are arranged starting from the lower or upper side wall of the transverse groove 238, with small protrusions 272 at the top, which are designed to transition the locking bolt 235 from the first position to the second position with little additional torque, which is less than or significantly less than the first torque level T1, so that vibrations or a ratchet sound is generated when the locking bolt 235 passes these protrusions 272.

Additional indications to the user, operator or surgeon that the first torque level T1 has been reached may be generated using other mechanisms, such as, for example, as shown in fig. 2D, a lever 275 having teeth, notches or a laterally extending arrangement parallel to the transverse slot 238 that engages the teeth, notches, cogs, pinion, ratchet 276 of the locking bolt 235, which will produce a ratchet sound and vibration when transitioning from the first position to the second position. Another example is shown in fig. 2E, where two levers 278 are symmetrically arranged on both upper and lower sides of the transverse slot 238, the bolt 235 has a square or rectangular cross-section, and the levers 278 have a saw-tooth shape to ensure that the transition from the first position to the second position can only take place once in one direction. The direction of the serrations will prevent the bolt 235 from moving rearwardly through the transverse slot 238. Instead of a lever, a portion of the intermediate cylindrical housing 237 may have an edge with serrations, waves or triangular teeth, and a portion 235 of the bolt has corresponding serrations, waves or triangular teeth, respectively, which are urged together by a spring mechanism. The biasing force of the spring mechanism urging the respective teeth together may be designed to provide a first torque level T1.

With the above embodiment, the breakage of the first frangible pin 227 or the snapping of the bolt 235 against a roughened, recessed or serrated structure (e.g., the lever 275 or protrusions 272, 276) as the bolt 235 transitions through the transverse slot 238, or a combination of both, produces audible, snapping and vibratory feedback to the user, operator or surgeon who is operating the handles 125, 225 and handle 29 with their hands to tighten the set screw 3 to reach and exceed the first torque level T1 without using a different handle or using a scale that requires reading of the torque level. The breakage of the first frangible pin 227 will produce a slight jolt, squeak or cracking sound, while the recessed structure will vibrate and squeak to ensure that the user will be certain that the first torque level on the set screw 3 has been reached. Additionally, the recessed configuration may also provide mechanical retention for rotational movement between the torque driver 210 and the intermediate cylindrical housing 237, and may itself serve as a torque limiting mechanism for the first torque level T1.

As another variation, the first break pin 227 is not present, but the protrusion 272 or lever 275 or ratchet-like element is designed to prevent the locking bolt 235 from sliding within the transverse slot 238 to provide mechanical retention when torque is applied between the torque driver 210 and the intermediate cylindrical housing 237 until the first torque level T1 is reached where the bolt 235 moves, transitions or slides to the side wall 239 of the transverse slot 238. The lever 275 and its length and mass, the protrusions 272, 276 and the longitudinal slot 271 may be designed to emit a specific acoustic sound that a user, surgeon or operator may hear as the bolt 235 slides through the transverse slot 238. Without the first break pin 227, the torque driver 210 can be rotated back relative to the intermediate cylindrical housing 237 such that the first position is again reached to have a reversible mechanism indicating the first torque level. In this regard, the first torque limiting mechanism and the first torque indicating mechanism may be integrated into a common device, such as by a ratchet-type device having one or more notches that engage with a sawtooth or wave-shaped structure, as described above.

In the context of the present invention, using the first frangible pin 227 and other types of retaining mechanisms having a longitudinal slot 271 and protrusion 272 as shown in fig. 2B and 2C or having a lever 275 and protrusions 272, 276, 279 as shown in fig. 2D and 2E, different devices, referred to herein as first torque retaining mechanisms, are described that can be used as indicators when the first torque is exceeded or reached, or as torque limiters to limit the application of the first torque to the first torque level, or both.

According to another aspect, a method of placing a spinal rod 7 into the heads 2 of a series of pedicle screws 1 and tightening or securing the set screws 3 to these heads is provided, as shown in fig. 3A to 3E. In these figures, different stages of the method are shown, showing by way of example three pedicle screws 1.1 to 1.3 attached to three vertebrae V1 to V3, but it is also within the scope of the embodiment to use different numbers of pedicle screws 1.1 to 1.3 and different numbers of vertebrae V1 to V3. These figures show schematically and exemplarily three adjacent vertebrae V1 to V3, each having a pedicle screw 1.1, 1.2 and 1.3, respectively, attached thereto, with a respective bone anchoring element 4.1, 4.2 and 4.3. None of the screw heads 2.1, 2.2 and 2.3 of the pedicle screws 1.1, 1.2 and 1.3 has a spinal rod 7 inserted therein prior to that shown in fig. 3A. As shown in fig. 3A, the user first places the left side of the spinal rod 7 into the screw head 2.1 by moving the spinal rod 7 in the direction B1 so that the rod 7 is placed in the U-shaped groove of the head 2.1, and then threadedly but loosely attaches the set screw 3.1 to the screw head 2.1 to ensure that the rod 7 does not move out of the U-shaped groove of the screw head 2.1. Typically, the spinal rod 7 will have a pre-bent shape that will be the desired shape of the spine for fusion, such that the adjacent vertebrae V1-V3 will be urged by the spinal rod 7 into the desired arrangement adjacent to one another.

Next, as shown in fig. 3B, by using the instrument or tool kit 100 as described above, the set screw 3.1 is screwed down into the screw head 2.1 to abut the rod 7 and is threadedly attached to the head 2.1 by the first torque level T1, with the pre-bent rod 7 located within the U-shaped recesses of the two adjacent heads 2.2 and 2.3. After this, the user attaches the set screw 3.2 to the screw head 2.2 threadedly but loosely. Next, as shown in fig. 3C, the set screw 3.2 is screwed down into the screw head 2.2 to abut against the rod 7 and is threadedly attached to the head 2.2 by the first torque level T1, again by using the instrument or tool kit 100 as described above. After this, the user attaches the set screw 3.3 to the screw head 2.3 threadedly but loosely.

Thereafter, as shown in fig. 3D, the set screw 3.3 is again screwed down into the screw head 2.3 by use of the instrument or tool kit 100 to abut against the rod 7 and is threadedly attached to the screw head 2.3 by the first torque level T1. At this stage, all pedicle screws 1.1, 1.2 and 1.3 are attached to the rod 7 by means of the fixation screws 3.1 to 3.3, which are tightened by torque at a first torque level T1. Next, as shown in fig. 3E, each set screw 3.1, 3.2, and 3.3 is tightened at a second torque level T2 from left to right to complete spinal stabilization with the spinal rod 7. This is accomplished by using the second torque limiting feature of the kit 100. For each set screw 3.1, 3.2 and 3.3 a different tool kit 100 is used. Generally, since the spinal rod 7 has a pre-bent shape, the spinal rod 7 may be placed into two or more pedicle screw heads at a time, and then the fixation screws 3.1 to 3.3 are tightened one by one along the spinal rod 7 in sequence from either direction. With this method, the tightening steps can be reduced to a single instrument kit, and even to the single instrument itself as described above, thus saving considerable operating time and costs.

Although the present invention has been disclosed with reference to certain preferred embodiments, numerous modifications, alterations, and changes to the described embodiments and equivalents thereof are possible without departing from the spirit and scope of the present invention. Accordingly, it is intended that the invention not be limited to the described embodiments, but that it be given the broadest reasonable interpretation according to the language of the following claims.