INTERBODY SPACER WITH INTEGRATED ATRAUMATIC INSERTION TOOL SYSTEM AND METHOD

Systems and methods can involve (I) an interbody spacer including: (A) at least one side, and (B) at least one cavity for containing a bone graft material; and (II) an insertion tool, in which the at least one cavity is inaccessible from the at least one side when the insertion tool is engaged with the interbody spacer, and in which the at least one cavity is accessible from the at least one side when the insertion tool is disengaged from the interbody spacer. In addition, other aspects are described in the claims, drawings, and text forming a part of the present disclosure.

BACKGROUND

With interbody fusion, first a complete discectomy and preparation of endplates of a desired disc space is performed, followed by placement of a structural implant, such as cage, spacer, or allograft, within such desired disc space. Although originating with anterior approaches to the lumbar spine, to be later refined with unilateral posterior approaches to the anterior column, more recently, lateral approaches, also known as lateral interbody fusion (LIF) has become preferred by a number of surgeons. Additional placement of bone grafts or extenders to assist interbody fusion can be performed. Furthermore, lateral interbody fusion (LIF) places the graft anterior to the instantaneous axis of rotation with the graft being exposed to compressive rather than tensile forces to likely enhance bone fusion. Also, lateral interbody fusion (LIF) can provide additional biomechanical support so that normal physiologic loads will be less likely to exceed stiffness and bending strength of posterior pedicle screw constructs. With immediate segmental stability, posterior segmental instrumentation can result in unloading and endurance limit of construct can be increased.

Lateral interbody fusion (LIF) is being used to address similar conditions that were subject of prior approaches, such as instability, deformity, infection, tumor, trauma, and degenerative disc disease. Similar to prior approaches, lateral interbody fusion (LIF) seeks to provide such results as solid fusion and restoration including (1) coronal and sagittal balance, (2) foraminal dimensions, and (3) disc space height. Unlike prior approaches, lateral interbody fusion (LIF) does so with typically minimal problems associated with prior approaches that tend to incur more complication and patient morbidity.

With its lateral approach to interbody fusion, lateral interbody fusion (LIF) involves access to the disc space through a minimally disruptive lateral, retroperitoneal, trans-psoas approach to the spine. A series of dilators are used for blunt dissection of the psoas major muscle. Since lumbar plexus nerves lie within the psoas, real-time electromyographic (EMG) monitoring directs passage. Some helpful consequences of this approach can include an absence of a requirement for mobilization of great vessels, or abdominal contents; and also, avoidance of injury to the hypogastric sympathetic plexus and avoidance of injury to the gastrointestional and genitourinary systems can occur to reduce or eliminate need for an approach surgeon. Other helpful consequences can include (1) avoidance of typical posterior approach-related complications, (2) avoidance of extensive muscle stripping and denervation that can otherwise be performed, (3) avoidance Retraction of the neural elements, and (4) avoidance of neurologic and dural related complications. Other advantages of lateral interbody fusion (LIF) can include the approach (1) being relatively simple to perform, with a rather gradual learning curve, and (2) involving decreased operative time, minimal soft-tissue disruption with less postoperative pain, minimal blood loss, shorter hospital stays and reduced time to recovery.

Lateral interbody fusion (LIF) can use relatively large interbody implants to be placed, which can more effectively restore foraminal dimensions, as well as, sagittal and coronal alignments. In optimal applications, the disc space is completely spanned by the implant from medial to lateral, which rests on the peripheral portion of the endplate, or the ring apophysis. It has been observed that the endplate peripheral portion can be stronger than the endplate central portion. As a consequence, larger implants can distribute endplate stresses distributed over a larger surface area, which lower bone-implant interface stresses. Consequently, greater resistance can be provided to implant subsidence.

Lateral interbody fusion (LIF) has been used to alleviate degenerative disc disease and axial low back pain, but its use is discouraged with cases involving severe central canal stenosis, significant scoliotic deformity, or moderate to severe spondylolisthesis. Use of lateral interbody fusion (LIF) further includes a variety of spinal pathologies, however, L5-S1 disc space exposure can be hindered by iliac crests limiting its use to anterior column stabilization above L5. These pathologies can include degenerative disc disease, complex spinal deformity, spondylolisthesis, thoracic or lumbar corpectomy and pathologies requiring lumbar total disc replacement. Other applications can include patients that need revision after either prior failed fusion surgery (pseudarthrosis, adjacent level disease) or revision of failed total disc replacement surgery. Lateral interbody fusion (LIF) can be used to remedy thoracic spine issues and with thoracic disectomy and corpectomy procedures so that thoracic disc herniations, thoracolumbar trauma, tumors and infections are also candidate conditions.

Regarding patient positioning, a radiolucent operating table is used that s capable of flexing near its midportion in which the patient is in the true lateral decubitus position with the greater trochanter positioned directly over the table break. The patient is secured to the operating room table using tape, and the table is flexed to increase the distance between the ribs and the iliac crest. The table is rotated as necessary to provide true AP and lateral images of the disc space.

Regarding retroperitoneal access, lateral interbody fusion (LIF) uses a one Or a two-incision technique including a direct lateral incision being the working portal centered over the target disc space. A posterolateral incision is used to gain access to retroperitoneal space and to guide safe passage of dilators and retractor system through retroperitoneal space. Skin and subcutaneous tissue are incised and abdominal obliques are bluntly dissected. Then after fascia is incised, retroperitoneal space is entered.

Regarding transpsoas access and disc exposure, after lateral interbody fusion (LIF) dilators are properly positioned and configured, the retractor system is secured and expanded, but not past midportion of vertebral body.

Regarding discectomy and end plate preparation, besides details similar to other types of spinal procedures, a lateral annulotomy is typically performed followed by a complete discectomy using pituitary rongeurs and curettes. Of note, over-aggressive decortication of the endplates should be avoided to minimize the risk of graft subsidence. Then the contralateral annulus can be released by passing a Cobb elevator completely across the disc space with both anterior annulus and posterior annulus being preserved.

Regarding interbody implant sizing and placement, proper interbody implant spacer sizing is determined, which is then packed with bone graft material. The implant is then impacted completely across the anterior to middle one-third of the disc space to position the interbody spacer over end plate outer rim on each side to provide support due to strength of the ring apophysis. Then Hemostasis is achieved, and wounds are irrigated and closed in layers.

Conventional lateral interbody fusion (LIF) procedure does have certain limitations such as it cannot be used to treat pathology involving the L5-S1 intervertebral disc since exposure is limited by the ipsilateral iliac crest.

SUMMARY

In one or more aspects, a system for bone graft material can include (I) an interbody spacer including: (A) at least one side, and (B) at least one cavity for containing the bone graft material, and; (II) an insertion tool, wherein the at least one cavity being inaccessible from the at least one side when the insertion tool is engaged with the interbody spacer, and wherein the at least one cavity being accessible from the at least one side when the insertion tool is disengaged from the interbody spacer. Wherein (A) the at least one side of the interbody spacer includes at least one depression, and (B) the insertion tool includes at least one shield sized to block accessibility to the at least one cavity from the at least one side of the interbody spacer when the insertion tool is engaged with the interbody spacer, and (C) the insertion tool being slideably engageable and slideably disengageable with the at least one depression of the interbody spacer. Wherein the at least one depression of the interbody spacer being sized and shaped to receive the at least one shield of the insertion tool when the at least insertion tool is engaged with the interbody spacer. Wherein the at least one depression includes at least one sunken planar surface. Wherein the at least one shield of the insertion tool includes at least one plate member, the at least one plate member being slideably engageable and slideably disengageable with the at least one depression of the interbody spacer. Wherein the at least one plate member of the insertion tool being generally rectangular in shape. Wherein the at least one plate member of the insertion tool including a thickness of less than 3 mm. Wherein the at least one plate member of the insertion tool being fabricated from stainless steel. Wherein (A) the at least one depression of the interbody spacer includes at least one channel, (B) the at least one plate member of the insertion tool includes a planar surface and at least one side extending from the planar surface, and (C) the at least one channel of the interbody spacer being sized to receive the at least one side of the at least one plate member when the planar surface of the at least one plate member is in contact with the interbody spacer. Wherein the at least one channel includes a beveled open end. Wherein the at least one channel includes a first channel and a second channel having the at least one cavity positioned therebetween. Wherein (A) the at least one side of the interbody spacer includes (1) at least one planar surface portion, and (2) an edge surface extending perpendicularly to the at least one planar surface portion, (B) the at least one plate member of the insertion tool includes an end, and (C) the edge surface of the interbody spacer being in contact with the end of the at least one plate member when the insertion tool is engaged with the interbody spacer. Wherein the at least one channel includes an end, the end being adjacent to the edge surface. Wherein the at least one side includes a lip member extending from the edge surface, the lip member being parallel with the at least one planar surface portion and spaced from the at least one planar surface portion to form a gap therebetween. Wherein (A) the at least one depression of the interbody spacer includes at least one channel, (B) the at least one plate member of the insertion tool includes a planar surface and at least one side extending from a portion of the planar surface located other than on an edge of the planar surface, and (C) the at least one channel of the interbody spacer being sized to receive the at least one side of the at least one plate member when the planar surface of the at least one plate member is in contact with the interbody spacer. Wherein the insertion tool includes (A) a support member, (B) at least one plate member having an exterior surface extending in a first direction away from the support member, (C) an elongated member having a first portion and a second portion, the first portion extending from the support member, the second portion extending from the first portion in a second direction opposite the first direction, and (D) the support member includes a rear surface, the first portion of the elongated member extending other than perpendicularly from the rear surface of the support member. Wherein the insertion tool includes (A) a support member, (B) at least one plate member having an exterior surface extending in a first direction away from the support member, (C) an elongated member having a first portion and a second portion, the first portion extending from the support member, the second portion extending from the first portion in a second direction opposite the first direction, and (D) the support member includes a rear surface, the first portion of the elongated member extending from the rear surface of the support member other than parallel with the first and second directions. Wherein the insertion tool includes (A) a support member, (B) at least one plate member having an exterior surface extending in a first direction away from the support member, (C) an elongated member having a first portion and a second portion, the first portion extending from the support member, the second portion extending from the first portion in a second direction opposite the first direction, and (D) the second portion of the elongated member including an upper surface being positioned in a first plane that is unoccupied by any other portion of the insertion tool, the first plane being spaced from the exterior surface of the at least one plate member a first distance.

In one or more aspects, a system can include an interbody spacer for bone graft material, the interbody spacer including: (I) at least one side including at least one sunken planar surface; and (II) at least one cavity for containing the bone graft material, the at least one cavity including an opening adjacent the at least one sunken planar surface.

In one or more aspects, a system can include an interbody spacer for bone graft material, the interbody spacer including: (I) at least one side including: (A) at least one planar surface portion, (B) at least one cavity, the at least one cavity for containing the bone graft material, (C) at least one opening into the at least one cavity, the at least one opening being adjacent the at least one planar surface portion, (D) a first channel extending into other portions of the interbody spacer from the at least one planar surface portion, and (E) a second channel extending into other portions of the interbody spacer from the at least one planar surface portion, wherein the at least one opening into the at least one cavity being positioned between the first channel and the second channel.

In one or more aspects, a system can include an insertion tool for an interbody spacer, the insertion tool including: (I) a support member; (II) an elongated member, at least a portion of the elongated member extending from the support member along a first direction; and (III) at least one plate extending from the support member along a second direction, the second direction being opposite the first direction.

In one or more aspects, a system can include An insertion tool for an interbody spacer, the insertion tool including: (I) a support member; and (II) an elongated member including a first portion and a second portion, the first portion extending from the support member, the second portion extending from the first portion, wherein the second portion extends at an angle to the first portion.

In one or more aspects, a method for positioning an insertion tool with respect to a gap between a generally planar exposed surface of a first vertebra and a generally planar exposed surface of a second vertebra, the insertion tool including at least one plate member with a generally planar exterior surface, the insertion tool containing an interbody spacer, the method can include (I) positioning the at least one plate member of the insertion tool in a first orientation wherein the at least one plate member being a first distance from the first vertebra and wherein the generally planar exterior surface of the at least one plate member being nonparallel with the generally planar exposed surface of the first vertebra and being nonparallel with the generally planar exposed surface of the second vertebra; and (II) positioning the at least one plate member of the insertion tool in a second orientation wherein the at least one plate member being a second distance from the first vertebra and wherein the generally planar exterior surface of the at least one plate member being parallel with the generally planar exposed surface of the first vertebra and being parallel with the generally planar exposed surface of the second vertebra, wherein the first distance is greater than the second distance.

In one or more aspects, a method for positioning an interbody spacer including at least one generally planar surface with respect to a gap between a generally planar exposed surface of a first vertebra and a generally planar exposed surface of a second vertebra, the method can include (I) positioning the interbody spacer in a first orientation wherein the interbody spacer being a first distance from the first vertebra and wherein the generally planar surface of the interbody spacer being nonparallel with the generally planar exposed surface of the first vertebra and being nonparallel with the generally planar exposed surface of the second vertebra; and (II) positioning the interbody spacer in a second orientation wherein the interbody spacer being a second distance from the first vertebra and wherein the generally planar surface of the interbody spacer being parallel with the generally planar exposed surface of the first vertebra and being parallel with the generally planar exposed surface of the second vertebra, wherein the first distance is greater than the second distance.

In addition to the foregoing, other aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein. Various other aspects are set forth and described in the teachings such as text (e.g., claims and/or detailed description) and/or drawings of the present disclosure. The foregoing is a summary and thus may contain simplifications, generalizations, inclusions, or omissions of detail; consequently, those skilled in the art will appreciate that the summary is illustrative only and is NOT intended to be in any way limiting. Other aspects, features, and advantages of the devices and/or processes and/or other subject matter described herein will become apparent in the teachings set forth herein.

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative implementations described in the detailed description, drawings, and claims are not meant to be limiting. Other implementations may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.

Implementations of systems and methods described herein concern, in general, lumbar interbody fusion procedures and, in particular, minimally invasive spine surgery involving lateral interbody fusion (LIF) and anterior interbody fusion (ALIF) using a lateral, retroperitoneal, trans-psoas or anterior approach for desired disc space access.

The approaches described below create surface pressure/load between the vertebral end plates and the implant during insertion and repositioning. These loads in conjunction with aggressively textured traumatic implants or custom implants designed to realign the spine, can lead to end plate violation. This intern can lead to coronal or sagittal alignment issues and possible revision surgery. Furthermore approach angles when inserting the implant can be effected by several anatomical variances, (high Iliac crest or rib cage). These approach angles can create uneven load disbursement and localized or specific end plate violation and subsequent sequela.

Interbody spacers can be typically surgically placed between two vertebrae. It is envisioned that implementations described herein offer improvements in placement procedures for interbody spacers by, for instance, reducing frictional loads experienced during such procedures. Implementations also offer other enhancements such as providing for, during placement procedures, protection of materials being contained by interbody spacers while also affording increased exposure of such materials to vertebrae surfaces after placement has been accomplished. Further enhancements can allow for nonconventional orientation options during interbody spacer placement procedures to address occasional hinderances otherwise presented by configurations of patient internal body structures.

Turning toFIG.1, depicted therein is a perspective view of interbody spacer10. In implementations, interbody spacer10is shown to include distal tapered lateral end10a, right side10b, proximal lateral end10c, left side10d, upper side10e, sunken upper portion10f, sunken lower portion10g, receptacle opening10h, left slot10i, right slot10j, proximal cavity10k, and distal cavity10l. In general, interbody spacer10and other interbody spacers discussed herein can includes sides of vary heights either with respect to one another, or with respect to various portions of a particular side. Hence, interbody spacer10and other interbody spacer implementations are not limited to the depicted shapes, but can be sized and shaped according to medical constraints or other factors directed to a particular implantation procedure. Also, in other embodiments, one or more cavities can be shaped other than those depicted herein, such as proximal cavity10k, and distal cavity10l. These shapes can include, but are not limited to, elliptical, rectangular, circular, semi-circular, etc. Furthermore, interbody spacer10can be manufactured from biologically accepted inert material, such as polyether ether ketone (PEEK), other thermoplastics, radiolucent materials, alloys, metals, or other materials having desired structural, mechanical, thermal resistance, chemical, or other desired properties.

In implementations, distal tapered lateral end10ais shown to include right surface10al, and upper surface10a2. In implementations, right side10bis shown to include right surface10b1. In implementations, proximal lateral end10cis shown to include proximal left corner10c1, proximal surface10c2, and proximal right corner10c3. In implementations, upper side10eis shown to include left upper surface10e1, distal upper surface10e2, and right upper surface10e3. In implementations, sunken upper portion10fis shown to include left beveled edge10f1, left edge10f2, proximal surface portion10f3, left surface portion10f4, mid surface portion10f5, left distal corner edge10f6, distal surface portion10f7, distal edge10f8, right distal corner edge10f9, and right beveled edge10f10. In implementations, sunken lower portion10gis shown to include left beveled edge10g1. In implementations, receptacle opening10his shown to include circumferential surface10h1, and end surface10h2. In implementations, right slot10jis shown to include left surface10j1, and distal surface10j2. In implementations, interbody spacer10is shown to include linear dimension A1, linear dimension A2, linear dimension A3, linear dimension A3a, linear dimension A3b, and linear dimension A4.

Turning toFIG.2, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1taken along cut line2-2shown inFIG.1. In implementations, distal tapered lateral end10ais shown to include distal surface10a3, and lower surface10a4. In implementations, sunken lower portion10gis shown to include right edge10g2, proximal surface portion10g3, left surface portion10g4, mid surface portion10g5, left distal corner edge10g6, distal surface portion10g7, and distal edge10g8. In implementations, interbody spacer10is shown to include lower side10m. In implementations, lower side10mis shown to include left lower surface10m1, and distal lower surface10m2. In implementations, interbody spacer10is shown to include linear dimension A5, linear dimension A6, and linear dimension A7.

Turning toFIG.3, depicted therein is a side-elevational end view of interbody spacer10ofFIG.1. In implementations, left side10dis shown to include left surface10d1. In implementations, sunken upper portion10fis shown to include right edge10f11. In implementations, sunken lower portion10gis shown to include right beveled edge10g10, and left edge10g11. In implementations, left slot10iis shown to include right surface10i1, and distal surface10i2. In implementations, lower side10mis shown to include right lower surface10m3. In implementations, interbody spacer10is shown to include linear dimension A8, linear dimension A9, linear dimension A10, linear dimension A11, linear dimension A13, and linear dimension A14.

Turning toFIG.4, depicted therein is a top plan view of interbody spacer10ofFIG.1. In implementations, distal tapered lateral end10ais shown to contain left surface10a5. In implementations, sunken upper portion10fis shown to include right surface portion10f12. In implementations, interbody spacer10is shown to include linear dimension A15.

Turning toFIG.5, depicted therein is a top plan view of interbody spacer12. In implementations, interbody spacer12is shown to include distal tapered lateral end12a, right side12b, proximal lateral end12c, left side12d, sunken upper portion12f, and cavity12k. In implementations, distal tapered lateral end12ais shown to include right surface12a1, upper surface12a2, distal surface12a3, and left surface12a5. In implementations, right side12bis shown to include right surface12b1. In implementations, proximal lateral end12cis shown to include proximal left corner12c1, proximal surface12c2, and proximal right corner12c3. In implementations, left side12dis shown to include left surface12d1. In implementations, interbody spacer12is shown to include left upper surface12e1, and right upper surface12e3. In implementations, sunken upper portion12fis shown to include left beveled edge12f1, left edge12f2, proximal surface portion12f3, left surface portion12f4, left distal corner edge12f6, distal surface portion12f7, distal edge12f8, right distal corner edge12f9, right beveled edge12f10, right edge12f11, and right surface portion12f12.

Turning toFIG.6, depicted therein is a top plan view of interbody spacer14. In implementations, interbody spacer14is shown to include distal tapered lateral end14a, right side14b, proximal lateral end14c, left side14d, right upper surface14e3, sunken upper portion14f, proximal cavity14k, mid cavity14l, and distal cavity14m. In implementations, distal tapered lateral end14ais shown to include right surface14a1, upper surface14a2, distal surface14a3, and left surface14a5. In implementations, right side14bis shown to include right surface14b1. In implementations, proximal lateral end14cis shown to include proximal left corner14c1, proximal surface14c2, and proximal right corner14c3. In implementations, left side14dis shown to include left surface14d1. In implementations, sunken upper portion14fis shown to include left beveled edge14f1, left edge14f2, proximal surface portion14f3, left surface portion14f4, left distal corner edge14f6, distal surface portion14f7, distal edge14f8, right distal corner edge14f9, right beveled edge14f10, right edge14f11, and right surface portion14f12.

Turning toFIG.7, depicted therein is a perspective view of insertion tool16. In implementations, insertion tool16is shown to include elongated member16a, support member16b, upper plate member16c, lower plate member16d, left tongue member16e, and right tongue member16f. In implementations, elongated member16ais shown to include distal portion16a1, and proximal portion16a2. In implementations, support member16bis shown to include right surface16b1, proximal surface16b2, and left surface16b3. In implementations, upper plate member16cis shown to include exterior surface16c1, right side16c2, right distal corner16c3, distal side16c4, left distal corner16c5, and left side16c6. In implementations, lower plate member16dis shown to include interior surface16d1, right side16d2, right distal corner16d3, and distal side16d4. In implementations, left tongue member16eis shown to include extension portion16e1. In implementations, right tongue member16fis shown to include extension portion16f1, and tongue portion16f2.

Turning toFIG.8, depicted therein is a side-elevational cross-sectional view of insertion tool16ofFIG.7taken along cut line8-8shown inFIG.7. In implementations, upper plate member16cis shown to include interior surface16c7. In implementations, lower plate member16dis shown to include exterior surface16d5. In implementations, engagement member16gis shown to include circumferential surface16g1, and end surface16g2. In implementations, insertion tool16is shown to include linear dimension B1, linear dimension B2, linear dimension B3, and linear dimension B4.

Turning toFIG.9, depicted therein is a top plan view of insertion tool16ofFIG.7. In implementations, insertion tool16is shown to include linear dimension B5, and linear dimension B6.

Turning toFIG.10, depicted therein is an enlarged top plan view of a dashed-circle portion of insertion tool16ofFIG.9labeled “10” shown inFIG.9. In implementations, insertion tool16is shown to include linear dimension B7, linear dimension B8, linear dimension B9, linear dimension B10, linear dimension B11, and linear dimension B12.

Turning toFIG.11, depicted therein is a side-elevational view of insertion tool16ofFIG.7.

Turning toFIG.12, depicted therein is an enlarged side-elevational view of a dashed-circle portion of insertion tool16ofFIG.11labeled “12” shown inFIG.11. In implementations, insertion tool16is shown to include linear dimension B13, linear dimension B14, linear dimension B15, linear dimension B16, linear dimension B18, linear dimension B19, and linear dimension B20. Manufacture of insertion tool16and other insertion tool implementations can utilize one or more rigid materials, such as, hardened stainless steel, other types or grades of steel, titanium, other metals or alloys, composites, natural or synthetic materials, etc.

Turning toFIG.13, depicted therein is a side-elevational end view of insertion tool16ofFIG.7.

Turning toFIG.14, depicted therein is a side-elevational end view of insertion tool16ofFIG.7.

Turning toFIG.15, depicted therein is a perspective view of interbody spacer10ofFIG.1containing bone graft material100and bone graft material102, and insertion tool16ofFIG.7moving in direction M1before engagement therewith. The bone graft material100and bone graft material102can include, but are not limited to, Demineralized Bone Matrix (“DBM”) packing, bone morphogenetic protein (BMP), collagen matrix, bone cement, other flowable grafting agents or materials, flaky or other non-flowable grafting agents or materials, other biological or non-biological materials or substances, or any other suitable grafting, filler, sponge, foam, or other porous or absorbent structure material.

Turning toFIG.16, depicted therein is a perspective view of interbody spacer10ofFIG.1and insertion tool16ofFIG.7as engaged therewith.

Turning toFIG.17, depicted therein is a side-elevational cross-sectional view of insertion tool16ofFIG.7engaged with interbody spacer10ofFIG.1taken along cut line17-17shown inFIG.16. As shown, interbody spacer10of interbody spacer10is releasably engaged with interbody spacer10of interbody spacer10. Such engagement can be accomplished with cooperative threading of interbody spacer10to match threading of interbody spacer10. Other engagement approaches can include utilized such as slip-fit, press-fit, friction-fit, tabbed connections, or any other standard or non-standard coupling considerations.

Turning toFIG.18, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool16ofFIG.7inside of retractor tool200that is running through body cavity132from body exterior130to gap spacing G1between vertebra120and vertebra122. As shown, interbody spacer10engaged with insertion tool16is about to be positioned into gap spacing G1between vertebra120having exposed surface120aand vertebra122having exposed surface122a.

Turning toFIG.19, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool16ofFIG.7starting to be positioned into gap spacing G2between vertebra120and vertebra122.

Turning toFIG.20, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool16ofFIG.7further proceeding to be positioned into gap spacing G3between vertebra120and vertebra122.

Turning toFIG.21, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool16ofFIG.7fully positioned between vertebra120and vertebra122.

Turning toFIG.22, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool16ofFIG.7being disengaged and retracted therefrom.

Turning toFIG.23, depicted therein is an enlarged side-elevational cross-sectional view of a dashed-circle portion of interbody spacer10ofFIG.1positioned in a gap between two vertebrae ofFIG.22labeled “23” shown inFIG.22.

Turning toFIG.24, depicted therein is a perspective view of interbody spacer18. In implementations, interbody spacer18is shown to include distal tapered lateral end18a, right side18b, proximal lateral end18c, left side18d, upper side18e, left upper channel18f, right upper channel18g, receptacle opening18h, left groove18iright groove18j, left lower channel18k, right lower channel18l, proximal cavity18m, distal cavity18n, and distal lower edge18o3. In implementations, distal tapered lateral end18ais shown to include right surface18a1, and upper surface18a2. In implementations, right side18bis shown to include right surface portion18b1, upper distal right surface portion18b2, and lower distal right surface portion18b3. In implementations, upper side18eis shown to include left upper surface18e1, distal upper surface18e2, distal upper edge18e3, right upper surface18e4, proximal upper surface18e5, and mid upper surface18e6. In implementations, left upper channel18fis shown to include left beveled distal edge18f1, right beveled distal edge18f2, and left side18f3. In implementations, right upper channel18gis shown to include left beveled distal edge18g1, right beveled distal edge18g2, and left side18g3.

Turning toFIG.25, depicted therein is a side-elevational cross-sectional view of interbody spacer18ofFIG.24taken along cut line25-25shown inFIG.24. In implementations, interbody spacer18is shown to include lower side180. In implementations, distal tapered lateral end18ais shown to include distal surface18a3, and lower surface18a4. In implementations, lower side18ois shown to include distal lower surface18o2, proximal upper surface18o5, and mid upper surface18o6.

Turning toFIG.26, depicted therein is a side-elevational end view of interbody spacer18ofFIG.24. In implementations, lower side18ois shown to include left lower surface18o1, and right lower surface18o4. In implementations, interbody spacer18is shown to include linear dimension C2, linear dimension C3, linear dimension C4, and linear dimension C5.

Turning toFIG.27, depicted therein is a top plan view of interbody spacer18ofFIG.24. In implementations, interbody spacer18is shown to include linear dimension C7.

Turning toFIG.28, depicted therein is a perspective view of an insertion tool20. In implementations, insertion tool20is shown to include elongated member20a, support member20b, upper plate member20c, lower plate member20d, left tongue member20e, and right tongue member20f. In implementations, elongated member20ais shown to include distal portion20a1, and proximal portion20a2. In implementations, support member20bis shown to include right surface20b1, proximal surface20b2, and left surface20b3. In implementations, upper plate member20cis shown to include exterior surface20c1, right side20c2, right distal corner20c3, distal side20c4, left distal corner20c5, and left side20c6. In implementations, lower plate member20dis shown to include interior surface20d1, right side20d2, right distal corner20d3, and distal side20d4. In implementations, right tongue member20fis shown to include extension portion20f1, and tongue portion20f2.

Turning toFIG.29, depicted therein is a side-elevational cross-sectional view of insertion tool20ofFIG.28taken along cut line29-29shown inFIG.28. In implementations, insertion tool20is shown to include engagement member20g. In implementations, lower plate member20dis shown to include left side20d6.

Turning toFIG.30, depicted therein is a top plan view of insertion tool20ofFIG.28. In implementations, left tongue member20eis shown to include tongue portion20e2.

Turning toFIG.31, depicted therein is a side-elevational cross-sectional view of insertion tool20ofFIG.28. In implementations, insertion tool20is shown to include linear dimension D1, linear dimension D2, linear dimension D3, linear dimension D4, and linear dimension D5.

Turning toFIG.32, depicted therein is a side-elevational end view of insertion tool20ofFIG.28. In implementations, insertion tool20is shown to include linear dimension D1, and linear dimension D2.

Turning toFIG.33, depicted therein is a side-elevational end view of insertion tool20ofFIG.28.

Turning toFIG.34, depicted therein is a perspective view of interbody spacer18ofFIG.24and insertion tool20ofFIG.28with insertion tool20moving direction M2toward interbody spacer18before engagement therewith.

Surfaces of left upper channel18f, right upper channel18g, left lower channel18k, right lower channel18lshown inFIGS.24,26, and34to be generally parallel with surfaces such as left upper surface18e1, right upper surface18e4, left lower surface18o1, and right lower surface18o4in some implementations can include at least one protrusion, depression, or both (not shown).

Surfaces of right side20c2, left side20c6, right side20d2, left side20d6shown inFIGS.28,29,31,32, and34to be generally parallel with surfaces such as exterior surface20c1, and interior surface20d1in some implementations can include at least one protrusion, depression, or both (not shown).

Turning toFIG.35, depicted therein is a perspective view of interbody spacer18ofFIG.24and insertion tool20ofFIG.28as engaged therewith.

Turning toFIG.36, depicted therein is a side-elevational cross-sectional view of insertion tool20ofFIG.28engaged with interbody spacer18ofFIG.24taken along cut line36-36shown inFIG.35.

Turning toFIG.37, depicted therein is a side-elevational cross-sectional view of interbody spacer18ofFIG.24engaged with insertion tool20ofFIG.28fully positioned into a gap between two vertebrae.

Turning toFIG.38, depicted therein is a side-elevational cross-sectional view of interbody spacer18ofFIG.24fully positioned into a gap between two vertebrae and insertion tool20ofFIG.28being disengaged and retracted therefrom.

Turning toFIG.39, depicted therein is an enlarged side-elevational cross-sectional view of a dashed-circle portion of interbody spacer18ofFIG.24positioned in a gap between two vertebrae ofFIG.38labeled “39” shown inFIG.38.

Turning toFIG.40, depicted therein is a perspective view of interbody spacer22. In implementations, interbody spacer22is shown to include distal tapered lateral end22a, right side22b, proximal lateral end22c, left side22d, upper side22e, left upper channel22f, right upper channel22g, receptacle opening22h, left groove22iright groove22j, left lower channel22k, right lower channel22l, proximal cavity22m, distal cavity22n, distal lower edge22o3, and lower lip portion22o7. In implementations, distal tapered lateral end22ais shown to include right surface22a1, and upper surface22a2. In implementations, right side22bis shown to include right surface portion22b1, upper distal right surface portion22b2, and lower distal right surface portion22b3. In implementations, upper side22eis shown to include left upper surface22e1, distal upper surface22e2, distal upper edge22e3, right upper surface22e4, right upper surface22e5, mid upper surface22e6, and upper lip portion22e7. In implementations, left upper channel22fis shown to include left beveled distal edge22f1, right beveled distal edge22f2, and left side22f3. In implementations, right upper channel22gis shown to include left beveled distal edge22g1, right beveled distal edge22g2, and left side22g3.

Turning toFIG.41, depicted therein is a side-elevational cross-sectional view of interbody spacer22ofFIG.40taken along cut line41-41shown inFIG.40. In implementations, interbody spacer22is shown to include lower side22o. In implementations, distal tapered lateral end22ais shown to include distal surface22a3, and lower surface22a4. In implementations, lower side22ois shown to include distal lower surface22o2, proximal upper surface22o5and mid upper surface22o6.

Turning toFIG.42, depicted therein is a side-elevational end view of interbody spacer22ofFIG.41. In implementations, lower side22ois shown to include left lower surface22o1, and right lower surface22o4.

Turning toFIG.43, depicted therein is a top plan view of interbody spacer22ofFIG.40.

Turning toFIG.44, depicted therein is a side-elevational cross-sectional view of interbody spacer22ofFIG.40engaged with insertion tool20ofFIG.28fully positioned into a gap between two vertebrae.

Turning toFIG.45, depicted therein is a side-elevational cross-sectional view of interbody spacer22ofFIG.40fully positioned into a gap between two vertebrae and insertion tool20ofFIG.28being disengaged and retracted therefrom.

Turning toFIG.46, depicted therein is an enlarged side-elevational cross-sectional view of a dashed-circle portion of interbody spacer22ofFIG.40positioned in a gap between two vertebrae ofFIG.45labeled “46” shown inFIG.45.

Turning toFIG.47, depicted therein is a side-elevational end view of insertion tool24. In implementations, insertion tool24is shown to include upper plate member24c, lower plate member24d, left tongue member24e, right tongue member24f, and engagement member24g. In implementations, upper plate member24cis shown to include exterior surface24c1, right upper wing portion24c1a, left upper wing portion24c1b, right side24c2, and left side24c6. In implementations, lower plate member24dis shown to include lower plate member24d, interior surface24d1, right upper wing portion24d1a, left upper wing portion24d1b, right side24d2, and left side24d6.

Surfaces of right side24c2, left side24c6, right side24d2, left side24d6shown inFIG.47to be generally parallel with surfaces such as24c1, and24d1in some implementations can include at least one protrusion, depression, or both (not shown).

Turning toFIG.48, depicted therein is a side-elevational end view of insertion tool24ofFIG.47. In implementations, insertion tool24is shown to include elongated member24a.

Turning toFIG.48A, depicted therein is a cross-sectional side-elevational view of insertion tool24ofFIG.47.

Turning toFIG.48B, depicted therein is a side-elevational cross-sectional view of interbody spacer22ofFIG.40engaged with insertion tool24ofFIG.47fully positioned into a gap between two vertebrae.

Turning toFIG.49, depicted therein is a side-elevational cross-sectional view of insertion tool26. In implementations, insertion tool26is shown to include elongated member26a, support member26b, upper plate member26c, lower plate member26d, and engagement member26g. In implementations, elongated member26ais shown to include distal portion26a1, proximal portion26a2, and upper surface26a3. In implementations, support member26bis shown to include proximal surface26b1. In implementations, upper plate member26cis shown to include exterior surface26c1. In implementations, lower plate member26dis shown to include exterior surface26d1. In implementations, insertion tool26is shown to include angular dimension F1, angular dimension F2, angular dimension F3, linear dimension F4, linear dimension F5, linear dimension F6, direction H1, and direction H2.

Turning toFIG.50, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at a first angle as described by reference line T0awith respect to reference line T0band commencing to be positioned into a gap between two vertebrae. In implementations, insertion tool26is shown to include upper surface26a3.

Turning toFIG.51, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at first angle ofFIG.50and incrementally closer to be positioned into a gap between two vertebrae.

Turning toFIG.52, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at a first angle ofFIG.50and incrementally closer to be positioned into a gap between two vertebrae.

Turning toFIG.53, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at a second angle and incrementally closer to be positioned into a gap between two vertebrae.

Turning toFIG.54, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at second angle of53and incrementally closer to be positioned into a gap between two vertebrae.

Turning toFIG.55, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49at first angle ofFIG.50and incrementally closer to be positioned into a gap between two vertebrae.

Turning toFIG.56, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1engaged with insertion tool26ofFIG.49fully positioned into a gap between two vertebrae.

Turning toFIG.57, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at first angle ofFIG.50being disengaged and retracted therefrom.

Turning toFIG.58, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at second angle ofFIG.53being disengaged and further incrementally retracted therefrom.

Turning toFIG.59, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at second angle ofFIG.53being disengaged and further incrementally retracted therefrom.

Turning toFIG.60, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at first angle ofFIG.50being disengaged and further incrementally retracted therefrom.

Turning toFIG.61, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at first angle ofFIG.50being disengaged and further incrementally retracted therefrom.

Turning toFIG.62, depicted therein is a side-elevational cross-sectional view of interbody spacer10ofFIG.1fully positioned into a gap between two vertebrae and insertion tool26ofFIG.49at first angle ofFIG.50being disengaged and further incrementally retracted therefrom.

Turning toFIG.63, depicted therein is a side-elevational cross-sectional view of interbody spacer18ofFIG.24being engaged with insertion tool28. In implementations, insertion tool28is shown to include elongated member28a, support member28b, exterior surface28c1, interior surface28d1, and engagement member28g. In implementations, elongated member28ais shown to include distal portion28a1, and proximal portion28a2.

Turning toFIG.64, depicted therein is a side-elevational cross-sectional view of interbody spacer22ofFIG.40being engaged with insertion tool28.