Anchor claws and systems

Abstract

To provide successful replacement of the injured or deteriorated spinal bone with artificial implants, which can involve consideration and understanding of inherent stresses on the spine and of biological properties of the body in response to devices.SOLUTION: Various implementations include anchoring nails, fixation apparatuses, spinal fixation systems, and related methods described in this disclosure. Some implementations include a fixation nail for an interbody fusion procedure, the fixation nail including a body having an arcuate primary axis extending from a distal end to a proximal end, the body having an outer surface that enables complete insertion and removal of the fixation nail between the vertebrae without threaded engagement, and the body further including an elongated recess spanning a majority of a length of the body, the elongated recess sized to at least partially encompass at least one of tissue or bone during insertion into a patient.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Reference to Related Application) This application is a non-provisional application claiming priority to Provisional Application No. 63 / 450,711, filed March 8, 2023, the entirety of which is incorporated herein for all purposes.

[0002] (Technical field) The present disclosure relates generally to medical devices, and more particularly to the field of spinal surgery and spinal fixation devices. [Background technology]

[0003] The spine is important to human physiology for mobility, support, and balance. Spinal injuries can be debilitating or fatal to the patient. Even small irregularities in the spine can cause devastating pain and loss of coordination.

[0004] Surgical procedures are commonly performed to correct problems with displaced, damaged, or degenerated intervertebral discs. Spinal fusion procedures generally involve removing part or all of the diseased or damaged intervertebral disc and inserting one or more intervertebral implants into the resulting disc space. Successful replacement of damaged or deteriorated vertebrae with artificial implants can involve consideration and understanding of the inherent stresses on the spine and the body's biological characteristics in response to the device. Summary of the Invention

[0005] The above needs and others are addressed by the embodiments of the anchor (or fixation) claws (also called anchors or fixation "blades"), fixation devices, spinal fixation systems, and related methods described in this disclosure. All examples and features mentioned below may be combined in any technically possible manner.

[0006] Some implementations include a fixation claw for an interbody fusion procedure, the claw having a body with an arcuate main axis extending from a distal end to a proximal end, the body having an outer surface that allows for full insertion and removal of the fixation claw between vertebral bodies without threaded engagement, the body including an elongated recess that spans a majority of the length of the body, the elongated recess sized to at least partially surround at least one of tissue or bone during insertion into a patient.

[0007] In certain aspects, the system includes an interbody for placement within a patient's spinal column, the interbody including at least one thru-hole, a nail sized for placement within the at least one thru-hole, and a nail guide configured to deploy the nail into the at least one thru-hole within the interbody, the nail guide including at least one biasing mechanism for deploying the nail without a threaded connection to the interbody.

[0008] In additional specific aspects, a method of positioning an interbody within a patient's spinal column includes inserting an interbody between an intervertebral disc within the patient's spinal column, pre-loading a nail into a nail guide positioned to engage the interbody and the patient's spinal column, and deploying the nail from the nail guide to secure the interbody to the patient's spinal column, wherein the nail has a body with an elongated recess extending a majority of the length of the body, the elongated recess sized to at least partially surround at least one of tissue or bone during deployment of the nail within the patient's spinal column.

[0009] Implementations may include one or any combination of the following features.

[0010] In certain instances, the exterior surface of the body is unthreaded. In some cases, the unthreaded exterior surface of the body allows for threadless engagement between the interbody and the vertebral bodies and / or vertebrae of the patient.

[0011] In certain aspects, the elongated recess extends along the major arcuate axis of the body. In certain aspects, the elongated recess encapsulates, captures, and / or accommodates a portion of the patient's tissue and / or bone during deployment of the nail into the patient's spinal column. In certain examples, the recess can act to accommodate the portion of the tissue and / or bone. In further examples, the recess is sized to prevent plastic displacement of the bone, for example, to capture a pocket in the bone.

[0012] In some cases, the body has a reduced thickness along the elongated recess.

[0013] In certain implementations, the elongated recess extends between separate wall portions of the body.

[0014] In some embodiments, the discrete wall portions have a total width measured across the major arcuate axis and the elongated recess has a width measured across the major arcuate axis, and the ratio of the total width of the discrete wall portions to the width of the elongated recess is from about 0.5:1 to about 2:1.

[0015] In certain implementations, the body includes a three-point head near the proximal end to facilitate insertion of the fixation nail into the patient.

[0016] In some cases, at least one point of the three-point head is proximal to another point of the three-point head.

[0017] In some embodiments, the two points of the three-point head are approximately aligned in the distal-proximal direction.

[0018] In certain embodiments, the three-point head provides a cutting surface during insertion of the fixation nail into the patient.

[0019] In some implementations, the fixation nails are configured to be pre-loaded into the nail guide before being inserted into the patient.

[0020] In some cases, the body includes fins extending axially at least partially along the arcuate major axis to stabilize the fixation claw between the vertebral bodies.

[0021] In some implementations, the proximal end of the body includes a slot sized to receive a removal tool for removing the fixation nail from the nail guide.

[0022] In certain embodiments, the body includes at least one generally flat portion adjacent the slot for engaging a biasing mechanism on the interbody.

[0023] In some cases, the slot has a keyed configuration.

[0024] In certain aspects, the keyed configuration allows for selective loading or unloading of the fixed jaw from the jaw guide.

[0025] In certain implementations, the body is additively manufactured.

[0026] In some embodiments, the locking tab is one of a plurality of locking tabs of different sizes, and the body includes at least one indicator of the size of the locking tab.

[0027] In some cases, the fixation nail is compatible with supine anterior lateral interbody fusion (ALIF) procedures and lateral ALIF procedures.

[0028] In certain embodiments, the at least one biasing mechanism includes a first biasing mechanism that controls deployment of the pawl into the at least one through-hole.

[0029] In some cases, the at least one biasing mechanism further includes a second biasing mechanism that prevents inadvertent ejection of the nail from the nail guide.

[0030] In certain implementations, the at least one biasing mechanism provides at least one of audible or tactile feedback that the pawl is secured within the pawl guide.

[0031] In some aspects, the system further includes an inserter for engaging the nail guide and an impactor coupled to the inserter for deploying the nail within the interbody space.

[0032] In certain cases, the pawl guide further includes a locking mechanism for engaging a complementary locking mechanism on the inserter.

[0033] In one aspect, the locking mechanism includes a multi-segment slot and the complementary locking mechanism includes a tab that complements a portion of the multi-segment slot.

[0034] In certain implementations, during deployment, the impactor drives the claws through slots in the claw guides.

[0035] In some cases, the impactor has a major axis that is off-axis relative to the major axis of the claw.

[0036] In some cases, the nail guide includes a depth stop to control the interbody positioning of the nail during deployment. In some instances, the depth stop is removable and / or reversible for a flush or countersunk configuration.

[0037] In some cases, the system further includes a removal tool for engaging the proximal end of the nail via a non-threaded mechanism.

[0038] In some embodiments, the removal tool includes a protrusion sized to engage with a keyed slot in the proximal end of the nail in a first orientation and to disengage from the keyed slot in the proximal end of the nail in a second orientation.

[0039] In certain implementations, the interbody includes a retaining feature and the removal tool further includes a ridge for engaging the retaining feature to enable removal of the nail from the interbody.

[0040] In some cases, the nails are configured to be pre-loaded into the nail guide before being inserted into the patient.

[0041] In some implementations, the body includes fins that extend axially at least partially along the arcuate major axis to stabilize the claw between the vertebral bodies.

[0042] In some cases, the system is used in a method of interbody fusion within a patient's spinal column.

[0043] In certain implementations, preloading the nail into the nail guide includes inserting the nail into a through-hole in the nail guide, the nail guide having at least one non-thread biasing mechanism for retaining the nail. In some cases, inserting the nail into the through-hole is performed by hand.

[0044] In some cases, deploying the nail through the at least one through hole in the nail guide is performed using an impactor, the impactor having a major axis that is off-axis with respect to a major axis of the nail during insertion.

[0045] Two or more features described in this disclosure, including features described in this Summary section, may be combined to form implementations not specifically set forth herein.

[0046] The foregoing presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key or critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

[0047] The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0048] [Figure 1] 10A-10C are perspective views of a fixing claw according to various implementations.

[0049] [Figure 2] 10 shows different sized locking jaws according to various implementations.

[0050] [Figure 3] 1A-1C show first perspective views of an intervertebral body coupled with a fixation claw according to various implementations.

[0051] [Figure 4] 4 shows a second perspective view of the interbody and fixation claw of FIG. 3. FIG.

[0052] [Figure 5] 1 shows the fixation nail and interbody after removal from the patient.

[0053] [Figure 6] 1 illustrates the removal tool and end portion of the nail in two positions according to various implementations.

[0054] [Figure 7] 1A-1C are perspective views of a removal tool according to various implementations.

[0055] [Figure 8] 1 illustrates a fusion system according to various implementations.

[0056] [Figure 9] FIG. 9 is a perspective view of a portion of the fusion system of FIG.

[0057] [Figure 10] 1A-1D show partial cross-sectional views of a pawl guide and pawls according to various implementations. [Figure 11] 1A-1D show partial cross-sectional views of a pawl guide and pawls according to various implementations. [Figure 12] 1A-1D show partial cross-sectional views of a pawl guide and pawls according to various implementations.

[0058] [Figure 13] 10A-10C are perspective views of a pawl guide showing depth stops according to various implementations.

[0059] [Figure 14] 14 is a cross-sectional view of the pawl guide showing the depth stop of FIG. 13. [Figure 15] FIG. 14 is a cross-sectional view of the pawl guide showing the depth stop of FIG. 13.

[0060] [Figure 16] 10A-10C are side views of the pawl guide showing the depth stops in different orientations.

[0061] [Figure 17] 10 illustrates a process of coupling an inserter to a nail guide according to various implementations.

[0062] [Figure 18] 1 is a flow chart illustrating processes in methods according to various implementations.

[0063] It should be noted that the drawings of the various implementations are not necessarily to scale. The drawings are intended to depict only typical aspects of the disclosure and therefore should not be considered limiting of the scope of the implementations. In the drawings, like numbers represent like elements between the drawings. DETAILED DESCRIPTION OF THE INVENTION

[0064] Various exemplary embodiments of devices and techniques for interbody fusion procedures are described herein. For clarity, not all features of an actual implementation are necessarily described herein. Of course, it should be understood that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developer's specific goals, including compliance with system- and business-related constraints that may vary from implementation to implementation. It should also be understood that such a development effort, while complex and time-consuming, would be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The devices, related systems, and methods described herein possess various inventive features and components that, individually and in combination, warrant patent protection.

[0065] It is understood that any given element of the disclosed embodiments of the present invention may be embodied in a single structure, a single step, a single substance, etc. Likewise, a given element of the disclosed embodiments may be embodied in multiple structures, steps, substances, etc.

[0066] The present disclosure provides fixation nails and related fixation (or anchor) systems, methods, and devices for interbody fusion procedures that advantageously incorporate, at least in part, a nail having an elongated recess that at least partially surrounds tissue and / or bone during insertion into a patient. The present disclosure further provides a nail guide configured to deploy the nail into at least one through-hole within the interbody and including at least one biasing mechanism for deploying the nail without a threaded connection to the interbody. The nail guide can be pre-loaded with the nail(s). Various disclosed implementations can improve patient outcomes when compared to traditional fusion procedures. For example, the disclosed aspects can improve operating room efficiency over traditional fusion procedures by reducing process steps. The disclosed aspects can also reduce incision size for fusion procedures compared to traditional devices and systems. Furthermore, the disclosed aspects can improve procedural safety compared to traditional fusion procedures by integrating instrument functionality.

[0067] Commonly labeled components in the figures are considered to be substantially equivalent components for purposes of illustration, and redundant descriptions of those components are omitted for clarity.

[0068] FIG. 1 is a perspective view of a fixation claw 10 (also called a "blade" or simply a "claw") for use in an interbody fusion procedure. The fixation claw 10 has an arcuate main shaft (a) extending from a proximal end 40 to a distal end 50 of a body 30. p ) In some non-limiting examples, the body 30 is additively manufactured. In various implementations, the body 30 has an outer surface 60 that allows for full insertion and removal of the nail 10 into the interbody 70 ( FIGS. 3 and 4 ) without threaded engagement. That is, the outer surface 60 is unthreaded in various implementations.

[0069] FIG. 1 illustrates a first size of fixation nail 10, and FIG. 2 illustrates various additional sizes of fixation nail 10, each of which is an example of any practical number of sizes available for a particular fusion procedure. In some embodiments, indicator 20 can provide information regarding the different sizes of each fixation nail 10, such as a visual indicator, such as an indicated size, and / or a tactile indicator of size. In some cases, the color or pattern of the fixation nail 10 is an indicator of size, as shown, for example, in the various colors (types (a), (b), and (c)) shown on the nail 10 of FIG. 2 compared to each other and to the nail 10 of FIG. 1.

[0070] 3 and 4 show side and perspective views, respectively, of an interbody 70 including a set of through-holes 80 for receiving and retaining fixation claws 10. As described herein, the claws 10 can be fully inserted (and retained) within the interbody 70 without threaded engagement. It is understood that in an interbody fusion procedure, the claws 10 can also be inserted into the patient, for example, to engage with a vertebral body. Further details of interbody fusion procedures are described, for example, in PCT Application No. US 2022 / 023224 (Spinal Implant with Flexible Screw Lock Mechanism, filed April 3, 2022), the entire contents of which are incorporated herein by reference.

[0071] Returning to FIG. 1 , the body 30 of the nail 10 includes an elongated recess 90 that spans the length (L) of the body 30. In some embodiments, the elongated recess spans a majority of L. In some instances, the elongated recess 90 spans 50 percent of L, in additional cases greater than 60 percent of L, in still other cases greater than 70 percent of L, and in additional cases greater than 80 percent of L. In various implementations, the elongated recess 90 is aligned with the major arcuate axis (a) of the body 30. pn) along the longitudinal axis of the proximal end of the proximal end of the proximal vertebral column 90. The elongated recess 90 may be sized to at least partially surround tissue and / or bone during insertion into a patient. For example, the elongated recess 90 may be sized to penetrate tissue and / or bone to encase, capture, and / or contain the tissue and / or bone. In certain examples, such as shown in the image of the nail 10 and interbody 70 removed from a patient in FIG. 5, the elongated recess 90 can encase, capture, and / or contain bone and / or tissue (tissue shown) 100. In certain cases, the nail 10 can capture or otherwise encase the tissue 100 without displacing it, e.g., engage the tissue 100 and / or bone without plastically displacing it. The elongated recess 90 can be sized to prevent or otherwise reduce plastic displacement of the tissue and / or bone, e.g., to capture a pocket of tissue and / or bone as it is inserted into the vertebral body. In some cases, the body 30 has a reduced thickness along the elongated recess 90. For example, the elongated recess 90 can extend between separate wall portions 110, 120 of the body 30 (FIG. 1). In these cases, the wall portions 110, 120 may extend along, for example, the arcuate major axis (a p ) than the base portion 132 of the body 30. In other words, the elongated recess 90 may have a thickness measured in a direction perpendicular to the arcuate major axis (a pn Width (w) measured across er ) and the width (w er The ratio of the total width of the separate wall portions 110, 120 to the total width of the wall portions 110, 120 is from about 0.5:1 to about 2:1.

[0072] In certain instances, the body 30 has a three-point head 130 near the distal end 50 to facilitate insertion of the fixation nail 10 into a patient (e.g., into bone and / or tissue 100). In some instances, at least one point 140 of the three-point head 130 is distal to another point 150 of the three-point head 130. In one embodiment, the three-point head 130 includes one distal point 140 and two relatively proximal points 150A, 150B, e.g., the two points 150A, 150B are spaced apart in a distal-proximal direction (axis (a pnIn various implementations, the three-point head 130 provides a cutting surface during insertion of the nail 10 into a patient.

[0073] As described herein, in some cases, the body 30 also includes an arcuate main axis (a p ) extending axially at least partially along the base 132. In at least one embodiment, the fin 160 extends distally from the base 132 and is formed on the opposite side of the body 30 from the recess 90. Further, as shown in FIGS. 1, 6, and 7, the proximal end 40 of the body 30 can include a slot 170 sized to receive a removal tool 180 configured to remove the nail 10 from the nail guide 230 (FIG. 8). The slot 170 can be sized to receive the removal tool 180, for example, an end 190 of the removal tool 180. FIG. 6 shows a cross-section of the proximal end 40 of the body 30 illustrating the interaction of the end 190 of the removal tool 180 with the slot 170. In some cases, the slot 170 has a keyed shape that allows for selective loading or removal of the nail 10 from the nail guide 230. For example, the keyed shape may include a first slot 200 sized to receive the end 190 of the removal tool 180 and allow insertion and removal of the end 190, and a second slot 210 adjacent the first slot 200 and sized to engage the end 190 to couple the end 190 with the nail 10, for example, for removal from the nail guide 230. In these cases, the first slot 200 allows movement of the end 190 relative to the nail in a first orientation (unlocking), and the second slot 210 restricts movement of the end 190 relative to the nail 10 in a second orientation (locking). In some examples, the first orientation and the second orientation are approximately perpendicular to each other, in other words, offset from each other by approximately 90 degrees.

[0074] FIG. 8 illustrates a system including an inserter 220 with a claw guide 230 for deploying one or more claws 10 into the interbody 70. In various implementations, the inserter 220 includes a probe 232 (or inner shaft) for passing through a corresponding slot 234 on the claw guide 230 and engaging a corresponding slot 236 in the interbody 70. For example, as shown in FIGS. 14 and 15 , a shaft (e.g., outer shaft) 238 of the inserter 220 is configured to engage with the claw guide 230 when the inserter 220 is threaded through the slot 234. Thus, once engaged, the interbody 70, claw guide 230, and inserter 220 are secured relative to one another. FIG. 8 also illustrates a set (e.g., two) impactors 240 for engaging slots 242 in the claw guide and deploying the (pre-loaded) claw(s) 10 from the claw guide 230 into the interbody 70. FIG. 9 shows a close-up view of the nail guide 230 and the body of the inserter 220. As described herein, the nail(s) 10 are configured to be pre-loaded into the nail slot(s) 250 of the nail guide 230 prior to insertion into the patient. In certain examples, the nail guide 230 includes two nail slots 250, one on each of the top and bottom of the nail guide body. In some cases, during a fusion procedure, the interbody 70 is positioned within the vertebral space before the nail(s) 10 are deployed to hold the interbody 70 in place within the spinal column ( FIGS. 3 and 4 ). In some cases, the nail(s) 10 are loaded into the nail slot(s) 250 in the nail guide 230, and the nail guide 230 is then inserted into the patient's incision to facilitate delivery of the nail(s) 10 into the interbody 70. As described herein, in certain cases, the claw(s) 10 are loaded (e.g., by hand) into the claw guide 230 prior to positioning the interbody 70 within the intervertebral space. FIG. 10 shows a cross section of the claw guide 230 detailing the placement of one claw 10 in a first position within the claw slot 250. In various implementations, as shown in FIG. 9 , the claw guide 230 is configured to accommodate multiple claws 10, e.g., two or more claws 10 within corresponding claw slots 250 for deployment into the interbody 70.

[0075] 10 and referring back to the perspective view of the claw(s) 10 in a first position within the claw guide 230 in FIG. 11 , at least one biasing mechanism 260 controls the deployment of the claw 10 into the through-hole(s) 80 within the interbody 70. In some cases, the biasing mechanism(s) 260 provide audible and / or tactile feedback that the claw 10 is secured within the claw guide 230, e.g., a force-and-release mechanism and / or an audible click, indicating that the claw 10 is secured by the biasing mechanism(s) 260. In certain examples, a first biasing mechanism 260A controls the deployment of the claw 10 into the through-hole 80 ( FIG. 9 ). In further examples, a second biasing mechanism 260B prevents unintentional release of the claw 10 from the claw guide 230, e.g., unintentional release that retracts the claw 10 from the claw slot 250. In some examples, at least one of the biasing mechanism(s) 260 includes a spring or retractable protrusion for engaging a surface of the pawl 10. In other examples, the biasing mechanism(s) 260 includes any deformable component with a spring-like property that returns to shape, for example, allowing the pawl 10 to pass when sufficient normal force is applied to the biasing mechanism 260. In some cases, such as shown in FIGS. 10-12 , each biasing mechanism 260 includes an arcuate contact surface 262 configured to contact a portion of the pawl 10 upon engagement to limit movement within the pawl slot 250, but allow the pawl 10 to pass through the biasing mechanism 260 when sufficient force is applied (e.g., via an impactor). 9, the claw 10 can be loaded into the claw slot 250, for example, by hand, with the biasing mechanism 260B preventing unintentional retraction (ejection out the rear (proximal) end of the slot 250) and the biasing mechanism 260A preventing unintentional ejection out the front (distal) end of the slot 250. The two biasing mechanisms 260A, B can cooperate to secure the claw 10 within the slot 250 and prevent rattle and / or ejection. In various implementations, as shown in FIGS. 11 and 12, the biasing mechanism 260B holds the claw 10 deep enough within the slot 250 so that the impactor 240 can engage the claw 10 and deploy it through the distal end of the slot 250.In certain cases, during deployment, the force of the impactor 240 on the claw 10 is sufficient to overcome the biasing mechanism 260A and allow the claw 10 to be deployed from the distal end of the slot 250 into the slot 80 in the intervertebral body 70.

[0076] 12 shows a cross section of the claw guide 230 with the claw 10 in a second position, i.e., during deployment from the claw guide 230 into the interbody 70 (not shown). In some cases, during deployment, the impactor 240 drives the claw 10 through the claw slot 250 and into the through-hole 80 in the interbody 70. In some instances, as shown in FIGS. 11 and 12, for example, the impactor 240 drives the claw 10 through the major axis (a pn ) is the off-axis major axis (a pi ) of the impactor 240. pi ) is approximately linear or straight, but the main axis (a pn ) is arcuate, for example, to complement the arcuate shape of pawl slot 250. In other words, the major axis (a) of impactor 240 is oriented such that impactor 240 contacts a substantially flat portion 270 of body 30 adjacent slot 170 off-center (e.g., axially off-center) relative to slot 170. pi ) is also offset relative to the proximal end 40 of the body 30. In some cases, the generally flat portion 270 of the body 30 is configured to help retain the claw 10 within the claw slot 250 by engaging with at least one of the biasing mechanisms 260, e.g., the second biasing mechanism 260B. In certain cases, the generally flat portion 270 of the body 30 engages the second biasing mechanism 260B after initial loading into the claw guide 230, and a surface 280 on the generally flat portion 270 is positioned to engage the first biasing mechanism 260A during deployment of the claw 250 from the distal end of the slot 250.

[0077] In certain implementations, as shown in FIGS. 13-16 , for example, the claw guide 230 can further include a depth stop 290 configured to control the position of the interbody 70 during deployment of the claw 10 within the interbody 70. In some cases, as shown in FIG. 15 , the depth stop 290 is positioned to prevent over-deployment of the interbody 70, for example, if the distal surface of the depth stop 290 contacts a vertebral body and limits movement of the interbody 70. The depth stop 290 can include an internal slot 292 sized to allow the inserter 220 to pass through without interference. In certain cases, as shown in FIG. 16 , for example, the depth stop 290 is removable and / or reversible for flush and / or countersunk configurations. In these cases, the depth stop 290 is sized to fit into a depth stop slot 300 in the claw guide 230 in at least two orientations. In a first orientation (a), the depth stop 290 limits insertion of the interbody 70 to a first depth (measured along the proximal-distal depth of the claw guide), and in a second orientation (b), the depth stop 290 limits insertion of the interbody 70 to a second, discrete depth. In a further example, the system can be configured to accommodate different claw guides 230 of different sizes, each having a correspondingly sized depth stop 290. According to some implementations, each of the discretely sized depth stops 290 (i.e., inserts) includes a mating feature that prevents loading into a claw guide 230 that does not correspond to that size depth stop 290. For example, each depth stop 290 can include a “fail-proof” or “poka-yoke” feature, such as an orientation-dependent mating feature that can only allow loading of the depth stop 290 into a slot 300 of one size. In a particular example, the depth stop 290 can include an asymmetric protrusion 310 configured to limit the depth to which the interbody 70 can be loaded into a vertebral body.

[0078] According to various implementations, as shown in the partial perspective view of the claw guide 230 in FIG. 17 , for example, the claw guide 230 also includes a locking mechanism 320 configured to engage with a complementary locking mechanism 330 on the inserter 220. In particular, FIG. 17 illustrates processes (i) to (iv) of inserting and engaging the inserter 220 with the claw guide 230. In various implementations, the locking mechanism 330 on the inserter 220 includes a multi-segment slot 340, and the complementary locking mechanism 320 on the claw guide 230 includes a tab 350 that complements a portion of the multi-segment slot 340 (e.g., the two slots 340 and two tabs 350 shown in FIGS. 9 , 14 , and 15 ). In various implementations, the multi-segment slot 340 includes at least two portions having different orientations, for example, two portions having approximately perpendicular orientations.

[0079] FIG. 18 is a flow chart illustrating processes in a method for positioning an interbody 70 within a patient's spinal column, according to various implementations. In some cases, the method is part of an anterior-lateral interbody fusion (ALIF) procedure or a lateral ALIF procedure. These procedures are not intended to limit the disclosed methods and devices, which may be applicable to other surgical procedures. With reference to FIG. 18 and the devices of FIGS. 8-12, a first process (P1) of the method can include preloading a nail 10 into the nail guide 230, the nail 10 being positioned to engage the interbody 70 and the patient's spinal column. As described herein, multiple nails 10 (e.g., two or more) can be preloaded into the nail guide 230 in a single process, e.g., by hand. A second process (P2) can include inserting the interbody 70 between discs in the patient's spinal column. Aspects of inserting the interbody 70 into a patient's spinal column and related procedures are described in PCT Application No. US2022 / 023224 (Spinal Implant with Flexible Screw Lock Mechanism, filed April 3, 2022), the entire contents of which are incorporated herein by reference. In various implementations, processes P1 and P2 may be performed simultaneously or in a different order (e.g., P2 before P1). As described herein, the nail guide 230 can be loaded with the nail(s) 10 prior to inserting the nail guide 230 into an incision adjacent the patient's spinal column.

[0080] In various implementations, as shown in FIGS. 8-12 , for example, preloading the claw guide 230 with the claw(s) 10 includes inserting the claw 10 into the claw slot 250 of the claw guide 230. As the claw 10 is inserted into the claw slot 250, the claw 10 engages with a first biasing mechanism 260A and then engages with a second mechanism 260B to retain the claw 10 within the claw slot 250. As described herein, a user can insert the claw 10, for example, by hand, through each claw slot 250 of the claw guide 230. Prior to, simultaneously with, or after inserting the claw(s) 10 into the claw slot 250, the inserter 220 can be secured to the claw guide 230 such that the spindle (a) of the impactor 240 is secured to the claw guide 230.pi ) is the main axis (a) of the jaw 10 during insertion. pn ) will be off-axis. In one example, the inserter 220 is coupled with the claw guide 240 before inserting the claw 10 into the claw slot 250. In some cases, the inserter 220 can engage a slot 234 in the claw guide 230 to secure the inserter 220 to the claw guide 230 ( FIG. 17 ). In various implementations, a handle 360 ​​on the inserter 220 can be actuated to engage the probe (or inner shaft 232) with the slot 236 in the interbody 70.

[0081] After the inserter 220 is secured to the claw guide 230, in a third process (P3), the impactor(s) 240 are used to deploy the claw(s) 10 from the claw guide 230 and secure the interbody 70 to the patient's spine ( FIG. 12 ). In such a case, the impactor(s) 240 are actuated (e.g., manually via a driver tool such as a mallet) to drive the claw 10 from the claw slot 250 in the claw guide 230 into the through-hole 80 in the interbody 70 and engage the patient. As described herein, the elongated recess 90 allows the claw 10 to engage the patient's tissue and / or bone without substantially displacing the tissue, e.g., without plastically displacing the tissue and / or bone. In various implementations, the fins 160 and flat portion 270 on the claw 10 can engage with retaining features 370 on the through-hole 80 in the interbody 70 to retain the claw 10 within the interbody 70 while engaging the patient's tissue and / or bone adjacent the interbody 70, as shown, for example, in FIGS. 3 and 4. In certain examples, such as those shown in FIGS. 3 and 4, the through-hole 80 to the interbody 70 can include a retaining feature 370, such as a lip, a deflectable latch, a retractable tab, or a spring element, configured to engage a portion of the fins 160 and / or the generally flat portion 270 of the claw 10 when deployed within the opening 80. Further description of exemplary retaining features 370 (e.g., lips) is provided in connection with the interbody disclosed in PCT Application No. US2022 / 023224, previously incorporated by reference herein. In various implementations, the interbody 70 is configured to engage the claw 10 and hold the claw 10 in contact with the patient's tissue and / or bone without a threaded connection.

[0082] 6 and 7 , in various implementations, a removal tool 180 can be used to engage the proximal end 40 of the nail 10 to remove the nail 10 from the nail guide 230 via a non-threaded mechanism. For example, after the nail 10 has been inserted into the nail guide 230, it may be desirable to remove the nail 10 (e.g., to replace it with a nail of a different size). The keyed slot 200 on the proximal end 40 of the nail 10 can be engaged with the end 190 on the removal tool 180 by first inserting the end 190 in one orientation and then rotating or otherwise reorienting the end 190 to a different orientation to engage the nail 10 with the keyed slot 200. Once engaged, the removal tool 180 can be used to withdraw the nail 10 from the interbody 70. In various implementations, such as when the interbody includes a retention feature 370, such as a latch lock, the removal tool 180 includes a ridge 380 to engage the latch lock and enable removal of the nail 10 from the nail guide 230. In such a case, when the removal tool 180 is positioned in the second orientation (FIG. 6), the ridge 380 engages the latch lock (e.g., the retaining feature 370) and allows the removal tool 180 to retract the claw 10 from the interbody 70.

[0083] As described herein, the disclosed fixation nails (or blades), systems, and related approaches according to various implementations offer numerous advantages over conventional fixation devices and systems. For example, the disclosed fixation nails, fixation systems, and methods can increase the effectiveness of spinal procedures and reduce operator (e.g., surgeon) error when performing such procedures. The disclosed fixation nails, systems, and approaches can be beneficial for both supine anterior lateral interbody fusion (ALIF) procedures and lateral ALIF procedures. The various disclosed implementations can reduce or avoid the use of complex and / or cumbersome surgical instruments, such as instruments for actuating U-joint mounts or bone burrs, and screwdrivers that require multi-level access to vertebral bodies. For example, fixation nails that do not include a threaded connection, as disclosed herein, can reduce or avoid the use of screwdrivers when connecting an interbody to a patient's bone and / or tissue. Furthermore, fixation nails with recesses, as disclosed herein, can reduce resistance from bone and / or tissue when loading the nail through the interbody. Additionally, nail guides that allow for pre-loading of nails, such as those disclosed herein, can enable a surgeon or other surgical professional to reduce surgical time and processes performed in or around a surgical access point. Compared to conventional approaches, the fixation nails, nail guides, systems and methods can also allow for less invasive (e.g., smaller) incisions in the patient for access to the vertebral body.

[0084] In various implementations, components described as being "coupled" to one another can be joined along one or more interfaces. In some implementations, these interfaces can include joints between different components, while in other cases, these interfaces can include rigidly and / or integrally formed interconnects. That is, in some cases, components "coupled" to one another can be formed simultaneously to define a single, continuous member. However, in other implementations, these coupled components can be formed as separate members and then joined by known processes (e.g., soldering, fastening, ultrasonic welding, bonding). In various implementations, electronic components described as being "coupled" can be linked via conventional wired and / or wireless means such that the electronic components can communicate data with one another. Additionally, subcomponents within a given component can be considered to be linked via conventional pathways, although not necessarily shown.

[0085] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Any reference to "or" herein is intended to include "and / or" unless specifically stated otherwise. As used in this specification and claims, unless otherwise specified, the terms "about," "approximately," "generally," and "substantially" refer to variations of no more than + / -1%, + / -2%, + / -3%, + / -4%, + / -5%, + / -6%, + / -7%, + / -8%, + / -9%, + / -10%, + / -11%, + / -12%, + / -14%, + / -15%, + / -16%, + / -17%, + / -18%, + / -19%, or + / -20%, depending on the embodiment. As a further non-limiting example, approximately 100 millimeters represents a range of 95 millimeters to 105 millimeters, 90 millimeters to 110 millimeters, or 85 millimeters to 115 millimeters, depending on the embodiment.

[0086] While the features of the invention described herein have been set forth in terms of preferred embodiments for accomplishing the objectives, it will be understood by those skilled in the art that variations can be achieved in light of these teachings without departing from the spirit or scope of the invention. Also, while the invention has been described according to its preferred use in spinal applications, it will be understood that the invention may be applied to a variety of other applications where surgical fixation is desired, such as the fixation of long bones.

[0087] Although multiple implementations have been described, it is nevertheless understood that additional modifications may be made without departing from the scope of the inventive concepts described herein, and therefore, other implementations are within the scope of the following claims.

Claims

1. 1. A system for an interbody fusion procedure, comprising: an interbody for placement in a patient's spinal column, the interbody including at least one through-hole; a locking tab sized for placement within the at least one through-hole; a pawl guide including a pawl slot; The fixation jaw comprises a body having an arcuate main axis extending from a distal end to a proximal end; the body has an exterior surface that allows for full insertion and removal of the fixation nail between vertebral bodies without threaded engagement; the body includes an elongated recess that spans a majority of the length of the body, the elongated recess being sized to at least partially surround at least one of tissue or bone during insertion into a patient; the claw guide is configured to deploy the fixation claw in the at least one through-hole between the vertebral bodies, the claw guide including at least one biasing mechanism for deploying the fixation claw without a threaded connection between the vertebral bodies; the at least one biasing mechanism includes a first biasing mechanism that controls deployment of the fixed claw into the through-hole and a second biasing mechanism that prevents unintentional release of the fixed claw from the claw guide; the first biasing mechanism and the second biasing mechanism are positioned such that, when the fixed pawl is inserted into the pawl slot of the pawl guide, the fixed pawl engages with the first biasing mechanism and then engages with the second biasing mechanism to hold the fixed pawl within the pawl slot. system.

2. The system described in claim 1, wherein the at least one biasing mechanism includes a spring or a retractable protrusion for engaging with a surface of the fixed claw.

3. The system described in claim 1, wherein each biasing mechanism includes an arcuate surface configured to contact a portion of the fixed claw and restrict movement within the claw slot when engaged, but allow the fixed claw to pass through the biasing mechanism when sufficient force is applied.

4. A system as described in any one of claims 1 to 3, wherein the claw slot has a proximal end and an opposite distal end, the fixed claw includes a flat portion of the body suitable for contact with an impactor, the flat portion engages with the second biasing mechanism after initial loading into the claw guide, and a surface of the flat portion is positioned to engage with the first biasing mechanism during deployment of the fixed claw from the distal end of the claw slot.

5. The system of claim 1 , wherein the outer surface is unthreaded.

6. The system of claim 1 , wherein the elongated recess extends along the major arcuate axis of the body.

7. The system of claim 1 , wherein the body has a reduced thickness along the elongated recess.

8. The system of claim 1 , wherein the elongated recess extends between separate wall portions of the body.

9. 9. The system of claim 8, wherein the discrete wall portions have a total width measured across the major arcuate axis and the elongated recess has a width measured across the major arcuate axis, and wherein a ratio of the total width of the discrete wall portions to the width of the elongated recess is from about 0.5:1 to about 2:

1.

10. The system of claim 1 , wherein the body includes a three-point head near the distal end to facilitate insertion of the fixation nail into the patient.

11. The system of claim 10 , wherein at least one point of the three-point head is distal to another point of the three-point head.

12. The system of claim 10 , wherein two points of the three-point head are generally aligned in a distal-proximal direction.

13. The system of claim 10 , wherein the three-point head provides a cutting surface during insertion of the fixation nail into the patient.

14. The system of claim 1 , wherein the fixation nail is configured to be preloaded into the nail guide prior to insertion into the patient.

15. The system of claim 1 , wherein the body includes fins extending axially at least partially along the arcuate major axis to stabilize the fixation claw between the vertebral bodies.

16. The system described in claim 1, wherein the proximal end of the main body includes a slot sized to receive a removal tool for removing the fixation claw from between the vertebral bodies, the slot having a keyed shape.

17. The system of claim 16 , wherein the body includes at least one generally flat portion adjacent the slot for engaging a biasing mechanism on the interbody.

18. 17. The system of claim 16, wherein the keyed feature allows for selective loading or unloading of the fixation claw from between the vertebral bodies.

19. The system of claim 1 , wherein the body is additively manufactured.

20. The system of claim 1 , wherein the locking jaw is one of a plurality of locking jaws of different sizes, and the body includes at least one indicator of the size of the locking jaw.

21. 10. The system of claim 1, wherein the fixation claw is compatible with supine anterior lateral interbody fusion (ALIF) procedures and lateral ALIF procedures.

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