Monolithic percutaneous screw system for spinal surgery

Abstract

In one aspect, the present disclosure provides an integrated percutaneous screw system for spinal surgery. The system includes: (i) a receiver having a distal base and a pair of opposing arms extending proximally from the base, a pair of opposing distal breakaway segments, each distal breakaway segment integrally connected to a proximal end of a corresponding arm of the arms, (ii) a pair of opposing proximal breakaway segments, (iii) a pair of opposing intermediate extenders, each intermediate extender extending from a distal end integrally connected to a corresponding distal breakaway segment of the distal breakaway segments to a proximal end integrally connected to a corresponding proximal breakaway segment of the proximal breakaway segments, and (iv) a guide cap integrally connected to both of the proximal breakaway segments.

Description

Technical Field

[0001] This disclosure generally relates to systems for spinal surgery, and more specifically, to monolithic percutaneous screw systems for spinal surgery. Background Technology

[0002] Spinal pathologies and conditions, such as scoliosis, kyphosis and other curvature abnormalities, degenerative disc diseases, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures, can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal conditions typically lead to symptoms including deformities, pain, nerve damage, and partial or complete loss of mobility.

[0003] Non-surgical treatments, such as medication, rehabilitation, and exercise, may be effective, but may not relieve the symptoms associated with these conditions.

[0004] Surgical treatments for these spinal conditions include correction, fusion, fixation, discectomy, laminectomy, and implantable prosthesis.

[0005] Surgical rods are commonly used to correct spinal abnormalities. Pedicle screw assemblies are typically used to facilitate fixation of one or more spinal rods relative to the spine. A pedicle screw assembly includes a bone screw attached to a receiver on a receiving arm. The bone screw is attached to the patient's vertebra, and the receiver receives a portion of the spinal rod.

[0006] In some cases, the receiver of a typical pedicle screw assembly can be angled relative to the bone screw to facilitate selective orientation of the spinal rod relative to the vertebra. When the bone screw is secured to the vertebra, the user can guide the spine into the desired shape when the rod is attached to the receiver.

[0007] Percutaneous pedicle screw fixation is a minimally invasive surgical technique that involves placing a pedicle screw and spinal rod through a very small skin incision. In some cases, the surgeon attaches an external extender device to the head of the pedicle screw. The extender device can help reduce the rod or manipulate it to the appropriate position within the head. There is a need for spinal implantation systems capable of reliably reducing the rod without the need for an external extender device. Summary of the Invention

[0008] The systems and processes disclosed herein generally relate to monolithic percutaneous screw systems for use in spinal surgeries such as minimally invasive spinal surgery.

[0009] In one aspect, this disclosure provides an integral percutaneous screw system for spinal surgery. The system comprises: (i) a receptacle having a distal base and a pair of opposing arms extending proximally from the base; a pair of opposing distal disconnect segments, each distal disconnect segment integrally connected to the proximal end of a corresponding arm of the arms; (ii) a pair of opposing proximal disconnect segments; (iii) a pair of opposing intermediate extenders, each intermediate extender extending from the distal end of a corresponding distal disconnect segment integrally connected to the distal disconnect segment to the proximal end of a corresponding proximal disconnect segment integrally connected to the proximal disconnect segment; and (iv) a guide cap integrally connected to both of the proximal disconnect segments. The respective proximal disconnect segments are sized and shaped such that a user can easily break the proximal disconnect segment when applying a first torque along a first plane to the cap. Furthermore, the size and shape of each of the distal break sections are configured such that (a) the distal break section will not break when the user applies a first torque to the cap, and (b) it can be easily broken by the user when a second torque is applied to the extender along a second plane that is generally orthogonal to the first plane.

[0010] In another aspect, this disclosure provides an integral percutaneous screw system for spinal surgery. The system comprises the four components ((i)-(iv)) mentioned above. The outer lateral surface of each distal disconnect segment is positioned rearward from the adjacent outer surface of a corresponding receiver arm connected to the distal disconnect segment. Each of the two end surfaces of each distal disconnect segment is positioned rearward from the adjacent lateral surface of a corresponding receiver arm connected to the distal disconnect segment. The outer lateral surface of each proximal disconnect segment is positioned rearward from the adjacent outer surface of a corresponding extender connected to the proximal disconnect segment. And each of the two end surfaces of each proximal disconnect segment is positioned rearward from the adjacent lateral surface of a corresponding extender connected to the proximal disconnect segment.

[0011] In another aspect, this disclosure provides an integral percutaneous screw system for spinal surgery. The system comprises the four components mentioned above ((i)-(iv)). Various optional features are described. For example, the size and shape of each of the proximal break segments are configured such that the user can easily break the proximal break segment when applying a first torque along a first plane to the cap.

[0012] The size and shape of each of the distal break sections are configured such that (i) the distal break section will not break when the user applies the first torque to the cap, and (ii) it can be easily broken by the user when the user applies a second torque to the extender along a second plane that is generally orthogonal to the first plane.

[0013] The size of the proximal break section includes the shorter length of the proximal break section as measured between its two ends, compared to the length of the distal break section between its two ends.

[0014] The size and shape of each of the proximal break sections are configured such that the user can easily break the proximal break section when applying a first torque to the cap along the first plane. The size and shape of each of the distal break sections are configured such that the distal break section (i) will not break when the user applies the first torque to the cap, and (ii) can be easily broken by the user when applying a second torque to the extender along a second plane that is generally orthogonal to the first plane. Furthermore, the shape of the distal break section includes a concave lateral surface.

[0015] In various embodiments, the outer lateral surface of each distal disconnect segment is positioned behind the adjacent outer surface of a corresponding receiver arm connected to the distal disconnect segment.

[0016] In various embodiments, the outer lateral surface of each distal disconnect segment is positioned behind the adjacent outer surface of the corresponding extender connected to the distal disconnect segment.

[0017] In various embodiments, each of the two end surfaces of each distal disconnect segment is rearward from the adjacent side surface of a corresponding receiver arm connected to the distal disconnect segment. Each of the two end surfaces of each distal disconnect segment may be rearward from the adjacent side surface of a corresponding extender connected to the distal disconnect segment.

[0018] In various embodiments, the outer lateral surface of each proximal disconnect segment is positioned behind the adjacent outer surface of a corresponding extender connected to the proximal disconnect segment.

[0019] In various embodiments, the outer lateral surface of each proximal disconnect segment is positioned behind the adjacent outer surface of the cap connected to the proximal disconnect segment.

[0020] In various embodiments, each of the two end surfaces of each proximal disconnect segment is positioned rearward from the adjacent side surface of a corresponding extender connected to the proximal disconnect segment.

[0021] In various embodiments, each of the two end surfaces of each proximal break section is positioned posterior to the adjacent outer surface of the cap connected to the proximal break section.

[0022] In various embodiments, each intermediate extender has an inner wall and an outer wall, the inner wall having an extender tooth profile; each arm has an inner wall and an outer wall, the inner wall having a receiver tooth profile; and the extender tooth profile is sized, shaped, and clockwise configured to match the receiver tooth profile, such that the retaining screw can be smoothly screwed proximally through the extender tooth profile onto the receiver tooth profile. In some cases, each tooth profile has a helical flange format for receiving a helical flange retaining screw, the tooth profile defining a threaded channel having a proximal extension space for receiving the threads of the retaining screw with a proximal extension flange.

[0023] In various embodiments, the cap has a proximal end with a generally circular cross-section. In some cases, the proximal end of the cap has a radially inward transition portion with curved or inclined surfaces to facilitate the guidance of external media into the central channel of the cap during system operation. In some cases, the cap has opposing arched distal cutouts.

[0024] In various embodiments, the cap has opposing arched distal cutouts, and each extender includes opposing transition surfaces that slope from the proximal end of the extender to a corresponding sidewall of the extender, each sloped surface opposite an arched distal cutout.

[0025] In various embodiments, each extender transition surface extends at an angle between approximately 30 degrees and approximately 60 degrees relative to the adjacent sidewall of the extender, and each distal cut extends at an angle between approximately 30 degrees and approximately 60 degrees relative to the adjacent outer wall of the cap.

[0026] Details of various aspects of this disclosure are set forth in the following figures and description. Other features, objectives, and advantages of the present technology will become apparent from the description, figures, and claims. Attached Figure Description

[0027] Figure 1 This is a perspective view of an integral percutaneous pedicle screw system according to an embodiment of the present technology;

[0028] Figure 2 It is connected from the first distal disconnect section to Figure 1 A perspective view of the proximal portion of the receiver assembly of the distal portion of the intrinsic extender of the system.

[0029] Figure 3 It is connected to the second proximal disconnect section Figure 1 A perspective view of the guide cap of the proximal portion of the intrinsic extender of the system;

[0030] Figure 4 yes Figure 3 Side view of the portion shown;

[0031] Figure 5 yes Figure 3 A perspective cross-section of a portion of the structure;

[0032] Figure 6 This is a perspective view of the proximal portion of the intrinsic extender after the guide cap has been disconnected from the extender;

[0033] Figure 7 A guide cap removal device adjacent to an integral percutaneous pedicle screw system is shown;

[0034] Figure 8 A guide cap remover device positioned above the guide cap of the system is shown;

[0035] Figure 9 This is a closer view of the remover device used to remove the guide cap;

[0036] Figure 10 It shows that keeping from Figure 1 The first integral percutaneous pedicle screw system removes the guide cap removal device, and the removal device is positioned similar to Figure 1 Above the second guide cap of the second monolithic percutaneous pedicle screw system of the system, for use in forming a multi-system spinal construct in the patient;

[0037] Figure 11 The diagram illustrates a removal device that retains first, second, and third guide caps removed from a corresponding monolithic percutaneous pedicle screw system, and that the removal device is positioned in a manner similar to... Figure 1 Above the second guide cap of the fourth integral percutaneous pedicle screw system of the system, for use in forming a multi-system spinal construct in the patient;

[0038] Figure 12 A diagram showing the removal of the guide cap from the cap remover instrument by the action of the plunger subsystem of the instrument; and

[0039] Figure 13 It is a side view cross-section of the proximal portion of the receiver assembly and the distal portion of the intrinsic extender, both having a helical flange thread profile for receiving the helical flange fixing screw. Detailed Implementation

[0040] This technology includes an integral percutaneous screw system. The system can be used for minimally invasive spinal surgery, for example, in the chest, thoracolumbar, or lumbar regions.

[0041] Exemplary procedures include, but are not limited to, spinal surgery or AIS surgery for the correction or improvement of juvenile idiopathic scoliosis.

[0042] The benefits of this technology include eliminating the need for external extenders, thus saving on manufacturing / product costs, storage space, shipping requirements, and time and effort during the procedure. For example, there is no need to attach the external extender to the pole holder or any cap, saving time. There is also no chance of incorrectly assembling the external extender to the pole holder or any cap.

[0043] The extender device consists of a PERC screw head with an extended bar groove height. The system's functionality also benefits from the geometry that facilitates easy and safe dissection of selected portions of the system after implantation and construction of the bar-shaped spinal correction construct.

[0044] Now turn to the attached figures, and more specifically to the first figure. Figure 1 This is a perspective view of a monolithic percutaneous pedicle screw system. The system is indicated by the number 100 in the accompanying drawing.

[0045] System 100 includes a distal retractor assembly 200 connected to a proximal guide cap 400 via an intermediate intrinsic extender component 300. The term intrinsic is used in conjunction with the nature of the extender 300, which is integrally or separately connected to the adjacent cap 400 and retractor 220.

[0046] The disconnect section 300 is connected to the receiver assembly 200 via a first distal disconnect section 250, and to the guide cap 400 via a second proximal disconnect section 350.

[0047] Refer to in order Figures 2 to 13 This further describes these components, sections, and multi-cap removal and retention devices.

[0048] Figure 2 yes Figure 1 A perspective view of the proximal portion of the receiver assembly 200 and the distal portion of the intrinsic extender 300 of system 100. The receiver assembly includes or is attached to the bone screw 210, and the receiver 220 is connected to the bone screw 210. In various embodiments, the head of the bone screw 210 and the head receiving portion of the receiver 220 are configured such that the head can be easily pushed into or popped into the receiver 220, and the head receiving portion will hold the head, and thus the bone screw abuts against the receiver 220 in the appropriate position. In use of system 100, the bone screw 210 is anchored to the patient's vertebrae, for example, to their vertebral region. In these cases, system 100 may include the term pedicle, such as an integral percutaneous pedicle screw system.

[0049] The receptacle assembly 200 can be configured in a single-axis configuration, allowing the receptacle 220 to move only relative to the bone screw 210 along a single plane, or it can be configured in a multi-axis configuration, allowing the receptacle 220 to move at any position relative to the bone screw 210 within a generally conical space. In the intended embodiment, the receptacle 220 and the bone screw 210 have a fixed configuration, thereby reducing the amount of receptacle 220 relative to the screw 210.

[0050] For both multi-axial and uni-axial configurations, the head of the bone screw 210 extends into the distal cavity (not shown in detail) of the receiver 220, and the head is movable within the cavity.

[0051] The receiver 220 includes opposing receiver arms 222 extending from the receiver base 224. The arms 222 define a rod groove between them.

[0052] Each receptacle arm 222 extends from a distal end to a proximal end, between side edges or walls 228, and between an outer wall and an inner wall having threaded teeth 226. In various embodiments, the threaded teeth have a helical flange form, such as in combination. Figure 13 Further description.

[0053] In some embodiments, the sidewall 228 of the receiver arm 222 is recessed, rearwarded, or offset by a distance 223 from the outer diameter (regardless of the maximum OD) of the receiver base 224. This causes the arm 222 to extend radially beyond the length of the base 224, resulting in a relatively low profile for the receiver 220 and thus the system 100, thereby improving visibility around the receiver 100 and reducing material costs and weight without compromising strength.

[0054] The posterior arm 222 is connected to the base 224 via a curved transition 221. This gradual change enhances the strength of the transition 221. Furthermore, the gradual interface limits the impact of edges, for example, by reducing the likelihood of a surgeon or assistant accidentally tearing sterile gloves while manipulating the receiver 220. The slight transition 221 also results in a smoother area over any adjacent patient tissue.

[0055] The first distal disconnect section 250 integrally connects the receptacle 200 to the intrinsic extender 300. Section 250 is connected to the receptacle 200 and extender 300 in a single manner, for example, rather than by the end user snapping, fastening, fitting, or otherwise connecting the sections to each other. For example, in the original manufacture of system 100, the connection may include the receptacle, the disconnect section, and the extender, which is formed together or semi-permanently attached (e.g., by welding).

[0056] The break section 250 can be configured in any of a variety of ways to make the section more susceptible to damage for breakage. In some embodiments, the break section 250 is made more susceptible to damage by (A) being thinner (measured from the inner wall to the outer wall) than one or both of the (i) arms 222 of the receiver 220 and (ii) the intrinsic extenders 300, and / or (B) having a width less than that of the adjacent (i) arms 222 of the receiver 220 and / or (ii) the intrinsic extenders 300 (from one end of the portion 250 to the other). The section 250 can alternatively or may also be configured to be breakable based on its material, for example by containing a material that is breakable or relatively brittle relative to the adjacent material of the arms 222 and / or the extenders 300.

[0057] In various embodiments, portions of the disconnected segment 250 are offset, recessed, or rearranged in one or more portions. For example, the end wall 252 of segment 250 may be rearranged by a distance 254 from the adjacent sidewall 228 of receiver 220. Less material at the disconnected segment can have the benefit of reducing material costs and weight without compromising the strength of segment 250. Offset of the distal disconnected segment 250 may also include the outer lateral surface 253 of the portion 250 spaced 251 from the adjacent outer wall 225 of receiver 220. The benefit of offset also reduces the impact of edges, for example, after the intrinsic extender 300 has been disconnected from receiver 220 (see reference). Figure 6 This reduces the likelihood that a surgeon or assistant might accidentally tear or get the sterile glove stuck while manipulating the receiver 220. The broken section 250 may have a certain degree of roughness, which, for example, better avoids situations where the section is positioned posterior to adjacent material in this manner. The offset also results in a smoother area on any adjacent patient tissue after the break, compared to a broken section 250 that extends further or completely to the adjacent surface 225 of the arm 222, such as extending to the top of the arm wall 228 and to the outer wall of the receiver 220.

[0058] The receiver 220 may also have a low-profile transition portion to reduce weight, lower material costs, and decrease postoperative impact on adjacent tissues, particularly the likelihood of tearing or trapping sterile surgical gloves. An exemplary transition portion includes a curved or sloping proximal side edge 258 of the receiver 220. 1 and the curved or inclined distal side edge 258 of this collection device 300. 2 The low-profile transition section may also include the angled or curved side end 256 of the receiver 220. 1 and the curved or tilted distal end 256 of this collection device 300. 2 The benefits of this type of retractor-extender include those similar to any of the benefits provided above in conjunction with the disconnect segment offset.

[0059] The internal thread profile 226 of the receiver 220 has a configuration corresponding to the internal thread profile 326 of the intrinsic extender 300. The configuration includes size, shape, orientation, and positioning. For example, the two thread profiles 226 and 326 are set in a direction of rotation to match each other, thereby allowing the retaining screw 1350 to be easily and smoothly inserted. Figure 13 Screw the extender thread into the receiver thread 226 to lock the spine rod (not shown) in the rod groove defined by the receiver arm 222.

[0060] In various embodiments, the height of the extender thread profile, measured in the longitudinal, distal-to-proximal direction, is greater than the height of the receiver thread profile. In some cases, the height of the extender thread profile is twice as large as the height of the receiver thread profile.

[0061] Figure 3 This is a perspective view of the guide cap 400. In various embodiments, the cap 400 is typically cylindrical and has a circular outline. The advantage of a rounded cap compared to the higher edge formed by the proximal end 301 of the extender 400 can be included in a cap without a sharp edge at the proximal end, the higher edge extending radially away from the centerline of the proximal end of the extender until the end surface is sealed and the surface transitions (e.g., Figure 3 The transition region 356 (referenced in the middle) is the point from the sidewall 303 of the extender. The rounded proximal end of the cap 400 thus reduces the chance of other objects, such as a surgeon's glove, implant, or instrument, getting stuck on the cap 400. The round or annular shape of the cap 400, or at least its proximal end, also facilitates the guiding function of the cap, better guiding the instrument into and through the cap 400 and downward along the longitudinal axis 10.

[0062] The guide cap 400 is integrally connected via the second proximal disconnect section 350. Figure 1 The proximal portion of the intrinsic extender 300 of system 100. Segment 350 is connected to the cap 400 and extender 300 in a single manner, for example, rather than by the end user snapping, fastening, fitting, or otherwise connecting the segments to each other. For instance, in the original manufacture of system 100, the connection may include the cap, the disconnected segment, and the extender, which is formed together or semi-permanently attached (e.g., by welding).

[0063] The proximal break section 350 can be configured in any of a variety of ways to make the section more susceptible to damage for breakage. In some embodiments, the proximal break section 350 is made more susceptible to damage by (A) being thinner than the thickness 359 (measured from the inner wall to the outer wall) of one or both of the adjacent walls of (i) the guide cap 400 and (ii) the intrinsic extender 300, or (B) having a width less than the width (from one end of the section 350 to the other) of the adjacent (i) guide cap 300 and / or (ii) intrinsic extender 300. The section 350 can alternatively or may also be configured to be breakable based on its material, for example by containing a fracture-prone or relatively brittle material (relative to the adjacent material of the guide cap 400 and / or extender 300).

[0064] The second break section 350 may be offset, recessed, or rearward from the lateral edge and side edge or wall of the intrinsic extender 300 in some way, and for similar reasons, the first break section 250 may be rearward in one or more sections, as described above. Figure 2 As described.

[0065] In various embodiments, the second disconnect segment 350 is configured to disconnect by applying a torque or force in a manner different from the torque or force used to engage the first disconnect segment 250. Although manipulation may involve applying torque, force, or a combination thereof, the action is referred to herein as torque for simplicity and is considered to include such actions unless explicitly described or required herein.

[0066] In some embodiments, the torque required to engage the first disconnect segment 250 and the second disconnect segment 350 can be in opposite directions—for example, along an orthogonal plane or a vertical plane. In one case, the second disconnect segment 350 is configured to break along the sagittal plane or in the sagittal direction in the patient reference frame, and the first disconnect segment 250 is configured to break by a medial-to-lateral torque or in a medial-lateral direction.

[0067] Regarding the exemplary breakage direction of the proximal break section 350, it is snapped before the distal break section 250 in various embodiments, see reference. Figure 4 In the case of implantation system 100, it enables the following: Figure 4 The plane of the page will align with the patient's sagittal plane, and then the sagittal moment will cause the tip or proximal end of the cap 400 to swing left or right along the curve. Sagittal motion is typically indicated by arrow 351 in the view.

[0068] Regarding the exemplary breakage direction of the distal break section 350, which in various embodiments is snapped after the proximal break section 250, see reference. Figure 9 In the case of implantation system 100, it enables the following: Figure 9The plane of the page will be inside-outside the patient's reference frame (i.e., see...). Figure 9 The view will be in a sagittal plane, such as the skull or coccyx (above and below the patient's spine), and then a medial-lateral (or central, outward) torque is applied to the extender 300 to cause the proximal end of the extender 300 to rock left or right along a curve. The medial-lateral movement is typically indicated by arrow 251 in the view.

[0069] The advantage of designing system 100 so that segments 250 and 350 are most easily broken in response to torques in different directions includes better allowing the user to selectively break system 100 at one segment without breaking the system at the other segment with the same action. In these embodiments, system 100 is designed, for example, such that when the user applies torque to cap 400 along the sagittal plane, for example using cap removal tool 700, the proximal break segment 350 is easily snapped, while the distal break segment 250 does not snap in motion. The distal segment 250 is designed to resist the sagittal plane torque more strongly than the medial-lateral torque. The user can then apply the medial-lateral torque to intrinsic extender 300, for example by an extender or tab-breaking device (not shown), to snap extender 300 from receptacle 220 to distal segment 250.

[0070] The system 100, comprising the break sections 250 and 350, can be configured in various ways to facilitate breakage of these sections in different corresponding directions. The primary examples relate to the geometry of the system 100, including size and shape. Various dimensions of these sections can be designed to facilitate breakage in response to a predetermined moment. Width, length, and height are primary examples. As an example, the relatively short length 352 of the proximal break section 350, compared to a longer length 352, makes it easier to break along... Figure 4 The torque applied to the cap 400 in either direction 351 makes it easier to fasten the cap from the extender 300 at section 350. Regarding the relative torque or force requirements for the fastening between the two sections 250, 350, the proximal disconnect section 250 can have a greater length than the length 352 of the proximal section 350. The longer distal section 250 will resist more fastening in response to the sagittal torque applied to the cap 400 and transmitted downwards to section 250.

[0071] In the intended embodiment, the cross-sectional surface shaping is configured to influence the degree of breakage of segments 250 and 350, respectively. The proximal break segment 350 may have a curved (e.g., recessed) end surface 353 (the shorter surface), thereby making segment 350 more easily snapped in response to a moment along the indicated direction 351. In some embodiments, surface 353 has at least one inner edge or corner, for example, by having a generally V-shaped concave surface compared to a fully curved concave surface, and said concave surface may be partially smooth, thereby guiding generally inwardly radially to the apex of the generally V-shape. Similarly, the distal break segment 250 may have a curved (e.g., recessed) lateral surface 253 (the longer surface), thereby making segment 250 more easily snapped in response to a moment along the indicated direction 351. Figure 9 The torque in the direction 251 shown (e.g., inside-outside direction) makes it easier to fasten. For similar reasons, the radially inner surface of the segment 250 opposite the outer surface 253 can be curved.

[0072] As the size and shape of the broken section material are designed to be easier to break in response to moments in a chosen direction, the size and shape can also be used to make breaking more difficult in response to moments in other directions. As an example, the end surface 252 of the distal broken section 250... Figure 2 The diagram is shown as generally flat, which makes it possible to pass through along the sagittal plane (e.g., along...). Figure 4 The torque applied to system 100 in the direction shown makes it more difficult to latch segment 250. Furthermore, by making end surface 252 convex, or to a certain extent convex, the latching resistance of segment 252 in response to torque in the sagittal plane can be increased. A similar principle may affect one or both sides (radial inner and outer surfaces) 355, 357 of the proximal disconnect segment 350. Figure 3 The design of surfaces 355 and 357 can be designed to be either flat or raised to some extent.

[0073] Figure 4 yes Figure 3 The portion shown is a side view. Reference numeral 430 indicates a first exemplary offset (e.g., sagittal or sagittal offset) between the rear end surface 353 of the proximal break section 350 (measured from any point on the surface in the case of non-flatness, such as at the radial innermost point) and one end or edge of the adjacent proximal end of the intrinsic extender 300.

[0074] Figure 3 and Figure 4 Transitional portions 458 with low or reduced profiles are also shown. 1 The proximal end of the intrinsic extender 300, and the low-profile transition portion 458 2The distal end of the guide cap 400. The proximal end of the intrinsic extender 300 may also include a low-profile side transition portion 356, which may include a ramp 357. The ramp 357 may be curved or arched, and / or inclined or curved at either end of the ramp.

[0075] In various embodiments, each of the side transition portions 356—for example, its slope 357—extends at an angle of about 30 to 60 degrees relative to the adjacent sidewall 303 of the extender, for example, at an angle of about 40 to 50 degrees, for example, at about 45 degrees, all as follows Figure 3 and Figure 4 As shown.

[0076] The receiver 220 may also have a low-profile transition portion to reduce weight, lower material costs, and decrease postoperative impact on adjacent tissues, particularly the likelihood of tearing or trapping sterile surgical gloves. An exemplary transition portion includes a curved or angled proximal lateral edge 258 of this receiver 300. 1 and the curved or inclined distal side edge 258 of the guide cap 400. 2 .

[0077] The guide cap 400 may further include a proximal external transition region 410, such as a curved surface or an inclined surface.

[0078] The benefits of offsetting and transitioning to reduce the impact of edges can include any of the benefits mentioned above related to the offset and transition between the receiver 220 and the intrinsic extender 300. Here, with regard to the first distal break section 250, the offset of the second break section 350 is particularly beneficial after the cap 400 has broken off from the intrinsic extender 300, because the broken break section 350 may have a certain roughness, which, for example, can be better avoided if the section 350 is positioned rearward from the adjacent material in this manner.

[0079] Compared to the fractured segment 350 that extends further or completely to the proximal lateral surface of the intrinsic extender 300, the offset also results in a smoother portion on any adjacent patient tissue after the fracture.

[0080] The outer diameter (OD) of the guide cap 400 can be larger than the OD of the intrinsic extender 300, such as... Figure 3 The distance 452 is indicated in the diagram. The benefit of a larger relative OD includes easier handling, which includes holding the guide cap 400 manually or by means of tools, instruments, or machines. Further benefits may include easier fastening of the guide cap 400 from the extender 300 at the proximal disconnection 450.

[0081] Figure 3 and Figure 4A cutout 456 is shown in the guide cap 400, which may be shown as curved or arched. The term "cutout" as used herein does not limit the manner in which the associated geometry is formed. The associated surface 456 is not necessarily formed by cutting or even machining, but may be formed by cutting or machining. The cutout 456 may be referred to herein, as included in the claims, by other terms such as transition portion 456.

[0082] In various embodiments, each cutout 456 has a surface 455 that extends at an angle of about 30 to 60 degrees relative to the adjacent sidewall of the cap 400 and / or the sidewall of the extender, for example, at an angle of about 40 to 50 degrees, for example, at about 45 degrees, all as described above. Figure 4 As shown.

[0083] Incision 456 offers various benefits, including reduced weight, less material used in manufacturing, lower costs, increased visibility during surgery, and improved handling by the surgeon or assistant. The lateral low-profile transition portion 356 can also be considered as an alternative to or in conjunction with the guide cap incision 456 to form an incision section, providing the same or similar benefits just mentioned, such as those associated with the cap incision 456, or, when used with the cap incision 456, adding the same benefits (e.g., even greater maneuverability). Incision 456, the distal transition portion 356, or both together can also provide a robust gap, facilitating access along... Figure 4 The torque in any direction 351 shown is applied from the extender 300 to the snap cap 400.

[0084] The central axis or longitudinal axis is in Figure 3 and Figure 4 The axis is represented by the number 10. Although not shown in every view, the axis as a whole is represented as the longitudinal axis of system 100, its components 200, 300, 400, and non-intrinsic parts and tools, such as fixing screw 1350. Figure 13 ), guiding instruments through system channels, such as fixation screw drivers (not shown) or bone filling devices (not shown), and multi-cap removal and retention instruments 700 ( Figure 7 ).

[0085] In various embodiments, the guide cap 400 includes a proximal radial internal transition portion 420. The transition portion 420 may be a curved surface or an inclined surface. The proximal internal transition portion can provide benefits similar to any of the benefits described above with respect to other transition portions. The proximal internal transition portion 420 can also facilitate the positioning (e.g., easier or otherwise better guidance) of media such as instruments (e.g., fixation screw drivers or bone filling tools), such as fixation screw drivers (not shown), within the channel 430 formed by the cap 400, and within the aligned proximal channel defined by the extender 300 and the receiver 220.

[0086] In various embodiments, the guide cap 400 further includes a retaining feature 460 adjacent to its proximal end. The retaining feature 460 may include an inwardly projecting portion or a lip 462.

[0087] The retaining feature 460 can be configured to engage a corresponding retaining feature (not shown) of a driver, bone filler, or other device placed in the cap 400 by means of the device locking or attaching to the retaining feature 460 of the cap, for temporary retention of the retaining feature of the device, and thus engagement with the device in a desired position relative to the cap 400. The device retaining feature has a geometry corresponding to the geometry (e.g., size and shape) of the retaining feature 460. For example, the device may have grooves or other shapes on the outer surface of the device (e.g., the distal or proximal surface of the device) machined or otherwise formed to correspond to the geometry of the cap retaining feature 460.

[0088] Figure 6 This is a perspective view of the proximal portion of the intrinsic extender 300 after the guide cap has been disconnected from the extender 300 at the proximal disconnect section 350. Section 370 of the disconnect section 350 remains at the proximal end of the intrinsic extender 300.

[0089] Similarly, Figure 6 As shown, the intrinsic extender 300 may include a transition surface 320 extending between the proximal end 301 of the extender 300 and the intermediate inner wall 320 of the extender 300. The transition surface 320 may have various benefits, including providing higher relative strength on the distal side of the surface 320, where the wall of the extender 300 (thickest at the proximal surface or at least thicker than the extender wall), while reducing material costs and weight. The transition surface 320 may also facilitate implant and device guidance, such as by guiding the fixation screw 1350 (Figure 1350), fixation screw driver (not shown), or bone-filling device (not shown) along the central axis 10 (…). Figure 4 and Figure 5 (As shown) the rod slot of the receiver 220 is reached from the channel of the cap 400 downward through the channel of the extender 300.

[0090] In various embodiments, due to the transition portion 320, the extenders 300 transition from a proximal spacing between them having an inner diameter that substantially matches the guide cap 400 to a distal spacing between them that substantially matches the inner diameter defined by the inner wall of the receiver arm 222.

[0091] Figure 7 A multi-cap removal and retention device 700 adjacent to an integral percutaneous pedicle screw system 100 is shown. In various embodiments, the device is configured to remove and retain multiple guide caps 400, and is therefore referred to as a multi-cap remover, multi-cap remover tool, or device, etc.

[0092] By being able to hold multiple caps at once, the multi-cap removal and holding instrument 700 saves movement and time in surgery by avoiding the need to empty the receiver after each cap 400 is removed or to use a separate remover for each cap.

[0093] The multi-cap removal and retention device 700 extends from the distal cap storage end 710 to the proximal handle end 720. The proximal end 710 is configured (e.g., sized and shaped) to be stored inside the proximal end of the cap 400 of the system 100.

[0094] The multi-cap removal and retention device 700 may also include a compartment 730 for receiving one or more caps 400. In various embodiments, the compartment 730 is a concealed case for receiving multiple caps 400. In various embodiments, the compartment 730 has sidewalls defining one or more windows or openings 732 to provide visibility of its interior, thereby allowing a user to see whether there are caps 400 in the compartment 730, and if so, how many caps.

[0095] The multi-cap removal and retention device 700 may also include an internal cap-pushing mechanism, such as a plunger 742 movable relative to the side wall of the compartment 730, within the compartment 730. The remover is configured such that a user can manipulate the remover to push the plunger 742 distally to push downwards onto one or more caps stored in the compartment 730, thereby ejecting multiple caps from the remover 700. This leaves space for guiding the cap remover 700 for subsequent capture of additional caps 400.

[0096] The guide cap remover 700 may include a cap retaining structure 712 adjacent to its proximal end 710. The cap retaining structure 712 is configured (e.g., given a geometry (size, shape)) such that the proximal end 710 of the remover 700 can slide relatively easily and readily on the guide cap 400. The cap retaining structure 712 is also configured such that the guide cap 400 captured by the remover 700 cannot easily fall out of the proximal end 710 after passing through the structure 712, for example by simple gravity or by moving the remover 700 around the operating room. The cap retaining structure 712 is further configured such that any captured guide cap 400 can be pushed proximally through the structure 712 by, for example, a cap discharge subsystem of the remover 700 including a plunger 742. In an embodiment, the cap retaining member 712 includes a lip 712 containing material, such as plastic or rubber, which is softer than the material of the chamber wall, which may include, for example, metal. A softer material is provided when the cap is pushed into or out of the compartment, but when the only force on the cap is gravity or normal non-cap removal activities by the user, the cap remains in the compartment to prevent premature detachment. This flexibility can be provided alternatively or through a slot in the distal end, such that the end includes fingers that can bend radially outward when the cap 400 is pushed. This feature is also considered schematically indicative of reference numeral 712.

[0097] Figure 8 The guide cap remover device 700 is shown, which has been positioned above the guide cap 700 of the system 100.

[0098] Figure 9 This is a closer view of the remover device 700 that removes the guide cap 400.

[0099] Figure 10 It shows that keeping from Figure 1 The first integral percutaneous pedicle screw system 100 removes the guide cap 400 of the removal device 700, and the removal device is positioned in a manner similar to... Figure 1 Above the second guide cap 401 of the second integral percutaneous pedicle screw system 101 of the system, for forming a multi-system spinal construct in the patient;

[0100] Figure 11 A removal device 700 is shown that retains first, second, and third guide caps 400, 401, and 402 removed from a corresponding integral percutaneous pedicle screw system, and the removal device is positioned in a manner similar to... Figure 1 Above the fourth guide cap 403 of the second integral percutaneous pedicle screw system of the system, for use in forming a multi-system spinal construct in the patient.

[0101] Figure 12The guide cap is shown to be removed from the cap remover device by the action of the cap pusher device (e.g., a device including plunger 742) of the device 700.

[0102] In various embodiments, such as Figure 11 As shown, the multi-cap removal and retention device 700 has, for example, a flanged spring base 1120, on which a spring 1130 is located or connected.

[0103] Spring 1130 is positioned within the body—for example, between handle 720 and compartment 730—and contacts sliding member 740 to bias sliding member proximally. In some cases, sliding member 740 includes a collar 740 extending around the body. Instrument 700 has an elongated actuator 1100 connecting sliding member 740 to plunger 742. In some cases, spring at least partially surrounds elongated actuator 1100 within the body.

[0104] In various embodiments, the main body portion has a body wall defining a longitudinal slot 744. Figure 10 The sliding member 740 may be connected, or is being connected, to a collar actuator member 1110 that connects the sliding member 740 to the elongated actuator 1100, the collar actuator member 1110 being slidably disposed in the slot 744.

[0105] Therefore, the collar 740 is connected to the plunger 742 via an elongated actuator 1100, such that when the user pushes the collar 740 distally, the collar connected to the actuator 1100 causes the elongated actuator 1100 to push the plunger 742 distally downward within the compartment 730. This pushes the plunger 742 downward against any guide cap 400 located in the compartment 730 until one or more caps 400 are ejected from the distal end of the instrument 700, pushed past any distal cap retaining structure 712, thereby ejecting or discharging them from the instrument 700.

[0106] Figure 13 This is a side cross-section of the proximal portion of the receiver assembly 200 and the distal portion of the intrinsic extender 300 according to various embodiments of the present technology, both having helical flange thread profiles for receiving helical flange retaining screws 1350. In these embodiments, thread profiles 226, 326 include a proximal flange receiving space 1300 for receiving the proximal flange 1354 of each threaded segment 1352. The benefits of the flanged thread profile include reducing the opening or closing of the arm 222 of the receiver 220. This can be particularly useful when the receiver 220 or at least the arm 222 has a material that is more inclined to open but has other benefits such as weight, cost, or machinability.

[0107] It should be understood that the various aspects disclosed herein can be combined in combinations other than those specifically presented in the detailed description and accompanying drawings. It should also be understood that, depending on the example, certain actions or events of any of any process or method described herein may be performed in a different order, added, combined, or omitted entirely (e.g., not all described actions or events are necessary for implementing the described technology).

[0108] Furthermore, for clarity, although certain aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

[0109] Unless otherwise specifically defined herein, all terms shall be interpreted as broadly as possible, including the meaning implied in the specification and the meaning understood by those skilled in the art and / or the meaning as defined in dictionaries, papers, etc. It must also be noted that, unless otherwise specified, the singular forms “a,” “an,” and “the” used in the specification and appended claims include plural referents, and the terms “comprises” and / or “comprising” as used in this specification specify the presence of the stated features, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0110] It should be understood that various modifications can be made to the embodiments in this disclosure. Therefore, the above description should not be construed as limiting, but merely as examples of various embodiments. Those skilled in the art will contemplate other modifications within the scope and spirit of the appended claims.

Claims

1. A monolithic percutaneous screw system for spinal surgery, the system comprising: A storage unit having a storage unit base and a pair of opposing storage unit arms extending proximally from the storage unit base; A pair of opposing distal disconnect segments, each distal disconnect segment being integrally connected to the proximal end of the corresponding arm in the arm; A pair of opposing proximal dissection segments; A pair of opposing intermediate extenders, each intermediate intrinsic extender extending from a distal end integrally connected to the distal end of the corresponding distal disconnect segment in the distal disconnect segment to a proximal end integrally connected to the proximal end of the corresponding proximal disconnect segment in the proximal disconnect segment; as well as A guide cap, integrally connected to both the proximal disconnect section and the guide cap; in: The size and shape of each of the proximal break sections are configured to have a recessed end surface and an outer surface that extend from the adjacent outer surface of the corresponding extender in the extender and / or the adjacent outer surface of the guide cap, thereby allowing the user to easily break the proximal break section when a first torque is applied to the cap along the first plane; and The size and shape of each of the distal break sections are configured to have a flat or convex end surface and a concave lateral surface, such that the distal break section (i) will not break when the user applies the first torque to the cap, and (ii) can be easily broken by the user when applying a second torque to the extender along a second plane that is generally orthogonal to the first plane.

2. The integral percutaneous screw system according to claim 1, wherein: The size of the proximal break section includes the shorter length of the proximal break section as measured between its two ends, compared to the length of the distal break section between its two ends.

3. The integral percutaneous screw system of claim 1, wherein the outer lateral surface of each distal disconnect segment is positioned rearward from the adjacent outer surface of a corresponding receiver arm connected to the distal disconnect segment.

4. The integral percutaneous screw system of claim 1, wherein the outer lateral surface of each distal disconnect segment is positioned posteriorly from the adjacent outer surface of the corresponding extender connected to the distal disconnect segment.

5. The integral percutaneous screw system of claim 1, wherein each of the two end surfaces of each distal disconnect segment is positioned rearward from the adjacent side surface of a corresponding receiver arm connected to the distal disconnect segment.

6. The integral percutaneous screw system of claim 1, wherein each of the two end surfaces of each distal disconnect segment is positioned rearward from the adjacent side surface of the corresponding extender in the extender connected to the distal disconnect segment.

7. The integral percutaneous screw system of claim 1, wherein each of the two end surfaces of each proximal disconnect segment is positioned rearward from the adjacent side surface of the corresponding extender in the extender connected to the proximal disconnect segment.

8. The integral percutaneous screw system of claim 1, wherein each of the two end surfaces of each proximal break section is positioned posteriorly from the adjacent outer surface of the cap connected to the proximal break section.

9. The integral percutaneous screw system according to claim 1, wherein: Each extender has an inner wall and an outer wall, the inner wall having an extender tooth profile; Each arm has an inner wall and an outer wall, the inner wall having a receiver tooth profile; and The extender tooth profile is set in size, shape, and rotation direction to match the receiver tooth profile, so that the fixing screw can be smoothly screwed proximally through the extender tooth profile onto the receiver tooth profile.

10. The integral percutaneous screw system of claim 9, wherein each tooth profile has a helical flange format for receiving a helical flange retaining screw, the tooth profile defining a threaded channel including a proximal extension space for receiving a proximal extension flange for receiving the screw thread.

11. The integral percutaneous screw system of claim 1, wherein the cap has a proximal end with a generally circular cross-section.

12. The integral percutaneous screw system of claim 11, wherein the proximal end of the cap includes a radially inner transition portion having a curved or inclined surface to facilitate the guidance of external media into the central channel of the cap during operation of the system.

13. The integral percutaneous screw system of claim 11, wherein the cap has opposing arched distal cutouts.

14. The integral percutaneous screw system according to claim 11, wherein: The cap has opposing, arched distal cutouts; and Each extender includes opposing transition surfaces that slope from the proximal end of the extender to the corresponding sidewall of the extender, each sloped surface being opposite one of the arched distal cuts.

15. The integral percutaneous screw system according to claim 14, wherein: Each extender transition surface extends at an angle between approximately 30 degrees and approximately 60 degrees relative to the adjacent sidewall of the extender; and Each distal incision extends at an angle between approximately 30 and approximately 60 degrees relative to the adjacent outer wall of the cap.

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