阅读说明：本技术 脊柱植入系统和方法 (Spinal implant system and method ) 是由 L·T·麦克布莱德 B·M·威尔丰 C·伊塔利艾 于 2020-04-23 设计创作，主要内容包括：脊柱构造包括限定横向轴线的主体。该主体包括布置在第一植入物腔体和第二植入物腔体之间的壁。该主体还限定与第一植入物腔体连通的第一开口和与第二植入物腔体连通的第二开口。第一开口限定第一轴线并且第二开口限定第二轴线。第一轴线和第二轴线中的至少一个相对于横向轴线以基本上非垂直的取向布置。公开了系统、手术器械、植入物和方法。(The spinal construct includes a body defining a transverse axis. The body includes a wall disposed between the first implant cavity and the second implant cavity. The body further defines a first opening in communication with the first implant cavity and a second opening in communication with the second implant cavity. The first opening defines a first axis and the second opening defines a second axis. At least one of the first axis and the second axis is disposed in a substantially non-perpendicular orientation with respect to the lateral axis. Systems, surgical instruments, implants, and methods are disclosed.)

1. A spinal construct, comprising:

a body defining a transverse axis, the body including a wall disposed between a first implant cavity and a second implant cavity,

the body further defining a first opening in communication with the first implant cavity and a second opening in communication with the second implant cavity, the first opening defining a first axis and the second opening defining a second axis,

at least one of the first axis and the second axis is disposed in a substantially non-perpendicular orientation relative to the lateral direction, such a configuration facilitating insertion into a patient through a smaller surgical incision formed during a surgical procedure.

2. A spinal construct as recited in claim 1, wherein the first axis and the second axis are arranged in a non-perpendicular orientation relative to the lateral axis, and the first axis is arranged in a parallel orientation relative to the second axis.

3. A spinal construct as recited in claim 1, wherein the first axis and the second axis are arranged in a non-perpendicular orientation relative to the lateral axis, and the first axis is arranged in a non-parallel orientation relative to the second axis.

4. The spinal construct of claim 1, wherein the first axis is arranged in a perpendicular orientation relative to the lateral axis and the second axis is arranged in a non-perpendicular orientation relative to the lateral axis.

5. The spinal construct of claim 1, wherein the body comprises a threaded surface defining the first opening.

6. The spinal construct of claim 5, wherein the body comprises a threaded surface defining the second opening.

7. The spinal construct of claim 1, wherein the body comprises a receiver having spaced apart arms defining the first implant cavity.

8. The spinal construct of claim 1, wherein the body comprises an arcuate receiver having a hook-like configuration defining the second implant cavity.

9. A spinal construct as recited in claim 1, further comprising a coupling member disposable with the first opening and engaged with a spinal rod disposed with the first implant cavity.

10. The spinal construct of claim 9, further comprising a coupling member disposed with the second opening and engaged with a spinal rod disposed with the second implant cavity.

11. The spinal construct of claim 1, wherein the cavities are arranged in a side-by-side orientation.

12. The spinal construct of claim 1, wherein the first cavity is adjacent to and spaced apart from the second cavity.

13. The spinal construct of claim 1, wherein the body comprises a connector.

14. The spinal construct of claim 1, wherein the cavities are arranged in a substantially parallel orientation.

15. A spinal construct as recited in claim 1, wherein at least one of the cavities includes a loading passage.

16. A spinal construct as recited in claim 1, wherein at least one of the cavities includes a top-loading passage.

17. A spinal construct, comprising:

a connector comprising a body connectable to tissue and defining a transverse axis, the body comprising a wall disposed between a first implant cavity and a second implant cavity, the body further defining a first opening in communication with the first implant cavity and a second opening in communication with the second implant cavity, the first opening defining a first axis and the second opening defining a second axis, at least one of the first axis and the second axis being disposed in a substantially non-perpendicular orientation relative to the transverse axis;

a first spinal rod in which the first implant cavity may be disposed;

a first coupling member disposable with the first opening and engageable with the first spinal rod;

a second spinal rod in which the second implant cavity may be disposed; and

a second coupling member may be disposed with the second opening and engageable with the second spinal rod.

18. The spinal construct of claim 1, wherein the body comprises a receiver having spaced apart arms defining the first implant cavity.

19. The spinal construct of claim 1, wherein the body comprises an arcuate receiver having a hook-like configuration defining the second implant cavity.

20. A spinal construct, comprising:

a body connectable to tissue and defining a transverse axis, the body including a wall disposed between a first enclosed implant cavity and a second implant cavity,

an end of a spinal rod disposed in the closed implant cavity,

the body further defines an opening in communication with the second implant cavity, the opening defining a first axis disposed in a substantially non-perpendicular orientation relative to the transverse axis.

Technical Field

The present disclosure relates generally to medical devices for treating musculoskeletal disorders, and more particularly to spinal implant systems and methods for treating the spine.

Background

Spinal pathologies and disorders such as scoliosis, kyphosis and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, lumbar spondylolisthesis, stenosis, tumors, and fractures may result from factors including trauma, disease, and degenerative conditions caused by injury and aging. Spinal disorders often result in symptoms that include deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as drug therapy, rehabilitation, and exercise, may be effective, however, may not alleviate the symptoms associated with these conditions. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy, and implantable prosthesis. As part of these surgical treatments, spinal constructs incorporating vertebral rods are often used to provide stability to the treated area. Upon healing, the rod transfers stress away from the damaged or defective area to make the proper correction and generally provide support for the vertebral members. During surgical treatment, one or more rods and bone fasteners may be delivered to the surgical site. The rod may be attached to the exterior of two or more vertebral members via fasteners. The present disclosure describes improvements over these prior art techniques.

Disclosure of Invention

In one embodiment, a spinal construct is provided. The spinal construct includes a body defining a transverse axis. The body includes a wall disposed between the first implant cavity and the second implant cavity. The body further defines a first opening in communication with the first implant cavity and a second opening in communication with the second first implant cavity. The first opening defines a first axis and the second opening defines a second axis. At least one of the first axis and the second axis is disposed in a substantially non-perpendicular orientation with respect to the lateral axis. In some embodiments, systems, surgical instruments, implants, and methods are disclosed.

In one embodiment, a spinal construct includes a connector including a body connectable to tissue and defining a transverse axis. The body includes a wall disposed between the first implant cavity and the second implant cavity. The body further defines a first opening in communication with the first implant cavity and a second opening in communication with the second implant cavity. The first opening defines a first axis and the second opening defines a second axis. At least one of the first axis and the second axis is disposed in a substantially non-perpendicular orientation with respect to the lateral axis. The first spinal rod may be disposed with a first implant cavity. The first coupling member may be disposed with the first opening and engaged with the first spinal rod. A second spinal rod may be disposed with a second implant cavity. The second coupling member may be disposed with a second opening and engaged with a second spinal rod.

In one embodiment, a spinal construct includes a body connectable to tissue and defining a transverse axis. The body includes a wall disposed between the first enclosed implant cavity and the second implant cavity. One end of the spinal rod is disposed in the closed implant cavity. The body further defines an opening in communication with the cavity. The opening defines a first axis disposed in a substantially non-perpendicular orientation relative to the lateral axis.

Drawings

The disclosure will become more apparent from the detailed description taken in conjunction with the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of a spinal implant system according to the principles of the present disclosure;

FIG. 2 is a perspective view of components of the system of FIG. 1;

FIG. 3 is a side cross-sectional view of the component shown in FIG. 2;

FIG. 4 is a side view of the components shown in FIG. 2;

FIG. 5 is a side cross-sectional view of the component shown in FIG. 1;

FIG. 6 is a perspective view of components of one embodiment of a system for positioning with vertebrae according to the principles of the present disclosure;

FIG. 7 is a side view of a component of another embodiment of a system according to the principles of the present disclosure;

FIG. 8 is a perspective view of the components shown in FIG. 7;

FIG. 9 is a top view of the components shown in FIG. 7;

FIG. 10 is a perspective view of components of a third embodiment of a system according to the principles of the present disclosure;

FIG. 11 is a cross-sectional view of the component shown in FIG. 10;

FIG. 12 is a cross-sectional view of the component shown in FIG. 11;

FIG. 13 is a top view of the components shown in FIG. 10; and

fig. 14 is another perspective view of the components shown in fig. 10.

Detailed Description

Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in terms of medical devices for treating musculoskeletal disorders, and more particularly, in terms of surgical systems and methods for treating spinal disorders. In some embodiments, the systems and methods of the present disclosure are used for spinal joint fusion, such as in the cervical, thoracic, lumbar and/or sacral regions of the spine.

In some embodiments, the surgical system of the present invention comprises a spinal construct having a connector. In some embodiments, the connector comprises a tulip hybrid cross-connect connector. In some embodiments, the connector includes a top-loading spinal rod passage and a side-loading spinal rod passage. The connector is configured to connect the spinal rod with a spinal construct including, for example, bone screws and spinal rods. In some embodiments, the connector defines a transverse axis and includes a first implant cavity and a second implant cavity. In some embodiments, at least one of the implant cavities is configured for a side-loaded spinal rod. In some embodiments, the connector includes an opening in communication with the first implant cavity and an opening in communication with the second implant cavity.

In some embodiments, the connector includes a second opening angled toward the first opening to facilitate insertion of the connector through a small incision in a patient. In some embodiments, the connector is used with cortical screw trajectory surgery. In some embodiments, the connector facilitates connecting spinal rods having a diameter of 4.75mm by utilizing an angled second opening for connecting a set screw at a side-loaded spinal rod. In some embodiments, the opening for the set screw is angled and not oriented perpendicular to the transverse axis of the connector, e.g., disposed directly in the connector. In some embodiments, the openings for the set screws are arranged in a substantially parallel relationship. In some embodiments, the openings for the set screws are angled and non-parallel. In some embodiments, the first set screw opening axis is disposed at an angle relative to a lateral axis of the connector and the second set screw opening axis is oriented perpendicular to the lateral axis of the connector, e.g., disposed directly in the connector. In some embodiments, the connector includes only one set screw opening that is angled relative to a transverse axis of the connector. In some embodiments, the surgical system of the present invention includes a spinal construct having a connector with converging angled set screw openings to facilitate a midline cortical bone screw trajectory. In some embodiments, this configuration maintains the surgical instrument in the same orientation throughout the surgical procedure while minimizing tissue exposure.

In some embodiments, one or all of the components of the surgical system may be disposable, peel-pack, pre-pack sterile devices. One or all of the components of the system may be reusable. The system may be configured as a kit with a plurality of sized and configured components.

In some embodiments, the surgical systems of the present disclosure can be used to treat spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and bone fractures. In some embodiments, the surgical systems of the present disclosure can be used with other bone and bone-related applications, including those associated with diagnostics and therapy. In some embodiments, the disclosed surgical systems may alternatively be used in surgical treatment of patients in prone or supine positions, and/or to reach the spine using various surgical approaches (including anterior, posterior midline, direct lateral, posterolateral, and/or anterolateral approaches), as well as to other body regions. The surgical system of the present disclosure may also alternatively be used in conjunction with surgical procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of the spine. The surgical systems of the present disclosure may also be used with animals, bone models, and other non-biological substrates, for example, in training, testing, and demonstration.

The surgical system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in conjunction with the accompanying drawings, which form a part of the disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification, including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value, and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It should also be understood that all spatial references (e.g., horizontal, vertical, top, upper, lower, bottom, left, and right) are for illustrative purposes only and may be varied within the scope of the present disclosure. For example, references to "upper" and "lower" are relative and are used only in context, and not necessarily "upper" and "lower".

As used in the specification, including the appended claims, "treating" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (normal or abnormal human or other mammal), using an implantable device, and/or using a device for treating the disease (e.g., a microdiscectomy device for removing a bulge or suffering from a hernia disc and/or bone spurs) in an effort to alleviate signs or symptoms of the disease or condition. Remission may occur before as well as after the onset of signs or symptoms of the disease or condition. Thus, treatment includes preventing a disease or an adverse condition (e.g., preventing the disease from occurring in a patient who may be predisposed to the disease but has not yet been diagnosed with the disease). Furthermore, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically involves surgery that has only a marginal effect on the patient. Treatment may comprise inhibiting the disease, e.g. arresting its development, or alleviating the disease, e.g. causing regression. For example, treatment may include reducing acute or chronic inflammation; relief of pain and reduction and induction of regrowth of new ligaments, bone and other tissues; as an aid to surgery; and/or any revision surgery. In some embodiments, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and/or bone, unless explicitly mentioned otherwise.

The following discussion includes a description of a surgical system incorporating a spinal construct, related components, and methods employing the surgical system according to the principles of the present disclosure. Alternative embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure that are illustrated in the accompanying drawings. Turning to fig. 1-5, components of a surgical system, such as a spinal implant system 10, are shown.

The components of the spinal implant system 10 may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and/or composites thereof. For example, the components of the spinal implant system 10 may be fabricated individually or collectively from materials such as: stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), superelastic metals, such as GUM) Ceramics and composites thereof: (Such as calcium phosphate (e.g., SKELITE)^TM) Thermoplastics (e.g., Polyaryletherketones (PAEKs) including Polyetheretherketones (PEEK), Polyetherketoneketones (PEKK), and Polyetherketones (PEK), carbon-PEEK composites, PEEK-BaSO₄Polymeric rubber, polyethylene terephthalate (PET)), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomer composites, rigid polymers (including polyphenylenes, polyamides, polyimides, polyetherimides, polyethylenes, epoxies), bone materials (including autografts, allografts, xenografts, or transgenic cortical and/or cortical spongiosa bone and tissue growth or differentiation factors), partially resorbable materials (e.g., composites of metals and calcium-based ceramics, PEEK and resorbable polymers), fully resorbable materials (e.g., calcium-based ceramics, such as calcium phosphate, calcium oxide, or combinations thereof, calcium oxide, and combinations thereof, Tricalcium phosphate (TCP), Hydroxyapatite (HA) -TCP, calcium sulfate, or other absorbable polymers, such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone), and combinations thereof.

The various components of the spinal implant system 10 can have a material composite, including the materials described above, to achieve various desired characteristics, such as strength, rigidity, flexibility, compliance, biomechanical properties, durability and radiolucency or imaging preference. The components of the spinal implant system 10 may also be fabricated, individually or collectively, from heterogeneous materials, such as from a combination of two or more of the above materials. The components of the spinal implant system 10 may be monolithically formed, integrally connected, or contain fastening elements and/or instruments, as described herein.

The spinal implant system 10 includes a spinal construct including a connector 12. In some embodiments, connector 12 is configured to connect first spinal rod 152 with bone screw 160 and second spinal rod 150, as shown in fig. 1, 5, and 6.

The connector 12 includes a body 14 defining a transverse axis X1, as shown in fig. 3. The body 14 includes a wall 18 (fig. 2). Wall 18 includes a surface 22 that defines a cavity, such as a receptacle 24, as shown in fig. 2. Receiver 24 includes a pair of spaced apart arms 26, 28 that define an implant cavity, such as a passageway 30 therebetween. The passage 30 is configured for top loading of a spinal implant, such as a spinal rod 150, as shown in fig. 1.

The arms 26, 28 each extend perpendicular to the axis X1, as shown in fig. 1. In some embodiments, the arms 26 and/or the arms 28 may be arranged in alternating orientations with respect to the axis X1, such as transverse and/or other angular orientations, such as acute or obtuse angles, coaxial and/or may be offset or staggered. The arms 26, 28 each include an arcuate outer surface extending between a pair of side surfaces. In some embodiments, at least one of the outer surface and the side surface of the arms 26, 28 has at least one recess or cavity therein configured to receive an insertion tool, compression instrument, and/or instrument for manipulating the connector 12.

The channel 30 is substantially U-shaped. In some embodiments, all or only a portion of the passage 30 may have alternative cross-sectional configurations, such as closed, V-shaped, W-shaped, oval, rectangular, triangular, square, polygonal, irregular-shaped, uniform, non-uniform, offset, staggered, and/or tapered configurations. In some embodiments, the surface 48 may include a gripping element or surface, such as, for example, one or more surfaces that are rough, arcuate, wavy, reticulated, porous, semi-porous, dimpled, and/or textured to facilitate engagement with the spinal rod 150. The passage 30 defines an axis a1 extending transversely to the axis X1. In some embodiments, the axes a1 may be arranged in alternating orientations with respect to the axis X1, such as, for example, parallel, perpendicular, and/or angular orientations, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered.

Receiver 24 includes a threaded surface 32 defining an opening 34. The opening 34 extends along an axis X2, as shown in fig. 3. The axis X2 is arranged in a substantially perpendicular direction with respect to the axis X1. In some embodiments, the axes X2 are arranged in alternating orientations with respect to the axis X1, such as, for example, transverse and/or other angular orientations, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered. The opening 34 is disposed in communication with the passage 30 to facilitate fixation of the spinal rod 150 to the connector 12.

The surface 32 is configured to engage a coupling member, such as a set screw 200, to retain the spinal rod 150 within the passage 30. In some embodiments, surface 32 may be arranged with set screw 200 in alternative securing configurations, such as a friction fit, a press fit, a locking protrusion/recess, a locking keyway, and/or an adhesive. In some embodiments, all or only a portion of surface 32 may have alternative surface configurations to enhance engagement with spinal rods and/or set screws, such as a rough, arcuate, undulating, lattice, porous, semi-porous, concave, and/or textured configuration.

The set screw 200 is configured to engage the spinal rod 150 to facilitate fixation and/or locking of the spinal rod 150 with the receiver 24. The set screw 200 may be disposed with the receiver 24 between an unlocked orientation that allows the spinal rod 150 to translate relative to the connector 12 and a locked orientation that allows the set screw 200 to secure the spinal rod 150 with the connector 12.

The body 14 includes an extension 40. The extension 40 includes an end 42 forming a receiver 44. The receiver 44 includes a surface 46 that defines an implant cavity, such as a passageway 48. Receiver 44 includes an arcuate configuration, e.g., a hook wall 50 defining a passage 48 and configured to capture spinal rod 152. Receiver 44 is configured to facilitate side loading of spinal rod 152 with connector 12.

As described herein, the passage 48 is configured for side loading of the spinal rod 152. In some embodiments, the passage 48 is disposed separate and apart from the passage 30. In some embodiments, the passages 48 are arranged in a side-by-side orientation relative to the passages 30. In some embodiments, the passages 48 are arranged in a parallel orientation with respect to the passages 30. In some embodiments, the passages 48 are arranged transverse to the passages 30. In some embodiments, the passages 48 may be arranged in various orientations, such as, for example, perpendicular, transverse, and/or angled orientations, such as acute or obtuse angles, relative to the passages 30. In some embodiments, the passages 48 may be arranged offset or staggered from the passages 30.

In some embodiments, the passage 48 may have various cross-sectional configurations, such as, for example, oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and/or tapered. In some embodiments, the surface 48 may include a gripping element or surface, such as, for example, a rough, arcuate, undulating, net-like, porous, semi-porous, dimpled, and/or textured surface to facilitate engagement with the spinal rod 152. The passage 48 includes an axis a2 extending transverse to the axis X1. In some embodiments, the axes a2 may be arranged in alternating orientations with respect to the axis X1, such as, for example, laterally, perpendicularly, and/or otherwise oriented, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered.

The extension 40 includes a surface 60 that defines an opening 62. Opening 62 extends between end 64 and end 66 and extends along axis X3, as shown in fig. 3. The axis X3 is disposed in a substantially non-perpendicular orientation with respect to the axis X1. In some embodiments, the axis X3 may be arranged in alternating orientations with respect to the axis X1, such as, for example, laterally, perpendicularly, and/or otherwise oriented, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered. The opening 62 is disposed in communication with the passage 48 to facilitate fixation of the spinal rod 152 to the connector 12.

The axis X3 is disposed in a non-parallel orientation with respect to the axis X2, as shown in fig. 3. The opening 62 is oriented such that the end 64 is angled toward the opening 34 to facilitate insertion of the connector 12. This configuration facilitates insertion of the connector 12 into a patient through a small surgical incision made during surgery. In some embodiments, the connector 12 may be used with cortical screw trajectory surgery. In some embodiments, the connector 12 facilitates connecting rods 150 each having a diameter of 4.75mm by utilizing angled openings 62 for connecting set screws 202 at side-loaded spinal rods 152. Converging angled set screws 200, 202 facilitate a midline cortical bone screw trajectory that maintains instrument orientation throughout the procedure while minimizing tissue exposure.

The surface 60 is configured to engage a coupling member, such as a set screw 202, to retain the spinal rod 152 within the passage 48. In some embodiments, the surface 60 may be arranged with the set screw 202 in alternative securing configurations, such as a friction fit, a press fit, a locking protrusion/recess, a locking keyway, and/or an adhesive. In some embodiments, all or only a portion of surface 60 may have alternative surface configurations to enhance engagement with spinal rods and/or set screws, such as a rough, arcuate, undulating, grid-like, porous, semi-porous, concave, and/or textured configuration.

Set screw 202 is configured to engage spinal rod 152 to facilitate fixation and/or locking of spinal rod 152 with receiver 44. The set screw 202 may be disposed with the receiver 44 between an unlocked orientation that allows the spinal rod 152 to translate relative to the connector 12 and a locked orientation that allows the set screw 202 to secure the spinal rod 152 with the connector 12.

In some embodiments, the spinal implant system 10 may include one or more connectors 12, such as those described herein, and/or fixation elements that may be employed with a single vertebral level or multiple vertebral levels. In some embodiments, the connector 12 engages the vertebrae in various orientations, such as in series, parallel, offset, staggered, and/or alternating vertebral levels. In some embodiments, connector 12 may be configured as a polyaxial screw, a radial angulation screw (pedicle screw), a pedicle screw, a monoaxial screw, a uniplanar screw, a fixation screw, an anchor, a tissue penetrating screw, a conventional screw, an expansion screw. In some embodiments, the connector 12 is used with wedges, anchors, buttons, clips, snaps, friction fittings, compression fittings, expansion rivets, staples, nails, adhesives, posts, connectors, holding plates, and/or posts.

In assembly, operation and use, the spinal implant system 10 similar to the systems and methods described herein is used in connection with surgical procedures, such as corrective treatment of applicable conditions or injuries to the affected section of the spinal column and adjacent areas within the body. The spinal implant system 10 may be fully or partially modified, removed, or replaced.

In use, to treat a selected portion of the vertebra V, including vertebrae V1, V2, as shown in fig. 6, a medical practitioner gains access to a surgical site including the vertebra V in any suitable manner, such as by cutting and retracting tissue. In some embodiments, the spinal implant system 10 may be used with any existing surgical method or technique, including open surgery, mini open surgery, minimally invasive surgery, and percutaneous surgical implantation, whereby the vertebra V can be accessed through a mini incision or cannula providing a protected access to the area. Once the surgical site is accessed, a particular procedure may be performed to treat the spinal disorder.

An incision is made in the patient and a cutting instrument (not shown) forms a surgical pathway for implanting components of the spinal implant system 10. Preparation instruments (not shown) may be used to prepare the tissue surfaces of the vertebrae V, as well as to aspirate and perfuse the surgical field.

Bone fastener 160 is engaged to vertebra V along lateral side L of vertebra V, as shown in fig. 6. Bone screw 160 is manipulated to drive, torque, insert, or otherwise connect bone screw 160 with vertebra V. Spinal rod 150 is delivered along a surgical path to a surgical site adjacent vertebra V. Spinal rod 150 is provided with bone screws 160 along vertebra V. The connector 12 is disposed adjacent to the spinal rod 150. Each connector 12 is manipulated to arrange spinal rod 150 with passage 30 from a top-loading direction.

Spinal rod 150 is secured to receiver 24 by engaging set screw 200 with surface 32 of opening 34. The set screw 34 is engaged with a surgical instrument, such as a driver (not shown), which advances the set screw 200 along X2 into engagement with the surface 32 in a locking orientation, as described herein. The driver engages the set screw 200 to fix the spinal rod 150 with the receiver 24 and to attach the spinal rod 150 to the vertebra V.

Spinal rod 152 is delivered to a surgical site adjacent vertebra V along a surgical path. Spinal rod 152 is disposed with passage 48 from a side-loading orientation. The set screw 202 is arranged with the opening 62 and engages the surface 60 along the axis X3. The set screw 202 is engaged with a surgical instrument, such as a driver (not shown), that advances the set screw 202 into the opening 62 in a non-locking orientation, as described herein. The spinal rod 152 is translatable relative to the connector 12 to position the spinal rod 152 relative to the spinal rod 150 and the connector 12. The driver engages the set screw 202 to fix the spinal rod 152 with the connector 12 and for connecting the spinal rod 152 with the vertebra V. In some embodiments, the spinal rods 152 are configured to share the load applied to the spinal rods 150. In some embodiments, the spinal rod 152 is configured to extend the spinal rod 150 to adjacent vertebral levels. Spinal rod 152 is configured to add support and strength to spinal implant system 10 along vertebrae V.

In some embodiments, the spinal implant system 10 includes a second set of connectors 12, bone screws 160, and spinal rods 150, 152 (not shown) that are delivered along a surgical path to a surgical site adjacent a contralateral side of the vertebra V. A set of connectors 12, bone screws 160, and spinal rods 150, 152 are connected to opposite sides of vertebra V, similar to lateral direction L as described herein. As described herein, the spinal construct of the spinal implant system 10 as described herein is secured with the vertebrae V in a side-by-side orientation and/or a bilateral arrangement to stabilize the vertebrae V and affect growth for corrective treatment to treat spinal pathologies. In some embodiments, one or all of the components of the spinal implant system 10 can be delivered or implanted in a selected order of assembly or as a pre-assembled device or can be assembled in situ, or the order of assembly of particular components of the spinal implant system 10 can vary according to practitioner preference, patient anatomy, or surgical procedure parameters.

Upon completion of the procedure, the surgical instruments, components, and non-implanted components of the spinal implant system 10 may be removed from the surgical site and the incision closed. One or more components of the spinal implant system 10 may be made of a radiolucent material such as a polymer. A radioactive marker may be included for identification under X-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, with the spinal implant system 10, surgical navigation, microsurgery, and image guidance techniques may be used to access, visualize, and repair spinal degeneration or injury.

In some embodiments, the spinal implant system 10 includes an agent that can be disposed, encapsulated, coated, or layered within, on, or about a component and/or surface of the spinal implant system 10. In some embodiments, the agent may comprise a bone growth promoting material, such as a bone graft, to enhance fixation of the bone fastener relative to the vertebra. In some embodiments, the pharmaceutical agent may include one or more therapeutic and/or pharmacological agents for release (including sustained release) to treat, for example, pain, inflammation, and degeneration.

In one embodiment, as shown in fig. 7-9, the spinal implant system 10 includes a connector 212 similar to the connector 12 described herein, similar to the systems and methods described herein.

The connector 212 includes a body 214 defining a transverse axis X4, as shown in fig. 7. The body 214 includes a wall 218. Wall 218 includes a surface 222 that defines a portion of a cavity, such as a receptacle 224 similar to receptacle 24 described herein. The receiver 224 includes a pair of spaced apart arms 226, 228 that define an implant cavity, such as a passageway 230 therebetween. As described herein, the passage 230 is configured for side loading of the spinal rod 150. The arms 226, 228 each extend along the axis X5 in a non-perpendicular orientation relative to the axis X4, as shown in fig. 7.

The receiver 224 includes a threaded surface 232 that defines an opening 234. The opening 234 extends along the axis X5 such that the opening 234 extends in a non-perpendicular direction X5 relative to the axis X4. In some embodiments, the axis X5 may be arranged in alternating orientations with respect to the axis X4, such as, for example, laterally, perpendicularly, and/or otherwise oriented, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered. The opening 234 is disposed in communication with the passage 230 to facilitate fixation of the spinal rod 150 to the connector 212. The surface 232 is configured to engage the set screw 200, as described herein, to retain the spinal rod 150 within the passage 230.

The main body 214 includes an extension 240. The extension 240 includes an end 242 that forms a receiver 244. End 244 includes a surface 246 defining a passageway 248. The receiver 244 includes a hooked wall 250 that defines the passageway 248 and is configured to capture the spinal rod 152. The receiver 244 is configured to facilitate side loading of the spinal rod 152.

As described herein, the passage 248 is configured for side loading of the spinal rod 152. In some embodiments, the passageway 248 is separate and apart from the passageway 230. In some embodiments, the passageways 248 are arranged in a side-by-side orientation with respect to the passageways 230. In some embodiments, the passages 248 are arranged in a parallel orientation with respect to the passages 230. In some embodiments, the passageway 248 is disposed transverse to the passageway 230. In some embodiments, the passageways 248 may be arranged in various orientations, such as, for example, perpendicular, transverse, and/or angled orientations relative to the passageways 230, e.g., at acute or obtuse angles. In some embodiments, the passages 248 are arranged offset or staggered from the passages 230. In some embodiments, the passageway 248 may have various cross-sectional configurations, such as, for example, oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and/or tapered. In some embodiments, the surface 248 may include a gripping element or surface, such as, for example, rough, arcuate, undulating, reticulated, porous, semi-porous, dimpled, and/or textured to facilitate engagement with the spinal rod 152.

The extension 240 includes a surface 260 that defines an opening 262. Opening 262 extends between end 264 and end 266 and extends along axis X6, as shown in fig. 7. The axis X6 is disposed in a substantially non-perpendicular orientation with respect to the axis X4. In some embodiments, the axis X6 may be arranged in alternating orientations with respect to the axis X4, such as, for example, laterally, perpendicularly, and/or otherwise oriented, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered. Openings 262 are disposed in communication with passageway 248 to facilitate fixation of spinal rod 152 with connector 212. The axis X6 is disposed in a parallel orientation relative to the axis X4 such that the opening 234 is disposed in parallel relative to the opening 262. Opening 262 is oriented such that end 264 is angled toward opening 234 to facilitate insertion of connector 212 through a smaller incision in a patient, as described herein.

The surface 260 is configured to engage the set screw 202, as described herein, to retain the spinal rod 152 within the passageway 248. The set screw 202 is configured to engage the spinal rod 152 to facilitate fixation and/or locking of the spinal rod 152 with the receiver 244. The set screw 202 and the receiver 244 are arranged between an unlocked orientation that allows the spinal rod 152 to translate relative to the connector 212 and a locked orientation that allows the set screw 202 to secure the spinal rod 152 with the connector 212.

In one embodiment, as shown in fig. 10-14, the spinal implant system 10 includes a connector 312 similar to the connector 12 described herein, similar to the systems and methods described herein.

The connector 312 includes a body 314 defining a transverse axis X7, as shown in fig. 10. The body 314 includes a wall 318. The wall 318 includes a surface 322 that defines a portion of the cavity, such as an enclosed receptacle 324. In some embodiments, the receiver 324 includes a passage 330 for disposal of the end of the spinal rod 150. In some embodiments, the spinal rod 150 is integrally formed with the receiver 324. In some embodiments, the spinal rod 150 is integrally connected with the receiver 324. In some embodiments, spinal rod 324 is coupled to receiver 324 via a fastening element and/or instrument.

The body 314 includes an extension 340. The extension 340 includes an end 342 that forms a receiver 344. The receptacle 344 includes a surface 346 defining a passageway 348. The receiver 344 includes a hooked wall 350 defining a passageway 348 and configured to capture the spinal rod 152. The receiver 344 is configured to facilitate side loading of the spinal rod 152.

As described herein, the passageway 348 is configured for side loading of the spinal rod 152. In some embodiments, the passageway 348 positions the spinal rod 152 separate and apart from the spinal rod 150. In some embodiments, the channel positions the spinal rod 152 in a side-by-side orientation relative to the spinal rod 150. In some embodiments, the passageway 348 positions the spinal rod 152 in a parallel orientation relative to the spinal rod 150. In some embodiments, the passageway 348 positions the spinal rod 152 transverse to the spinal rod 150. In some embodiments, the passageway 348 can position the spinal rod 152 in various orientations, such as, for example, perpendicular, transverse, and/or angled orientations, such as at acute or obtuse angles, relative to the spinal rod 150. In some embodiments, the passageway 348 can position the spinal rod 152 offset or staggered from the spinal rod 150. In some embodiments, the passageway 348 can have various cross-sectional configurations, such as, for example, oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and/or tapered. In some embodiments, the surface 348 may include gripping elements or surfaces, such as, for example, roughened, arcuate, undulating, reticulated, porous, semi-porous, dimpled, and/or textured to facilitate engagement with the spinal rod 152.

The extension 340 includes a threaded surface 360 that defines an opening 362, as shown in fig. 12. Opening 362 extends between end 364 and end 366 and along axis X8, as shown in fig. 12. The axis X8 is disposed in a substantially non-perpendicular orientation with respect to the axis X7. In some embodiments, the axis X8 may be arranged in alternating orientations with respect to the axis X7, such as, for example, perpendicular, transverse, and/or other angular orientations, such as, for example, acute or obtuse angles, coaxial, and/or may be offset or staggered. The opening 362 is disposed in communication with the passageway 348 to facilitate fixation of the spinal rod 152 with the connector 312. Opening 362 is oriented such that end 364 is angled toward receiver 324 to facilitate insertion of connector 312 through a smaller incision in a patient, as described herein.

The surface 360 is configured to engage the set screw 202, as described herein, to retain the spinal rod 152 within the passageway 348. The set screw 202 is configured to engage the spinal rod 152 to facilitate fixation and/or locking of the spinal rod 152 with the receiver 344. The set screw 202 may be disposed with the receiver 344 between an unlocked orientation that allows the spinal rod 152 to translate relative to the connector 212 and a locked orientation that allows the set screw 202 to secure the spinal rod 152 with the connector 312.

It should be understood that various modifications may be made to the embodiments in the present disclosure. Therefore, the above description should not be construed as limiting, but merely as exemplifications of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.