阅读说明：本技术 外科手术器械和方法 (Surgical instruments and methods ) 是由 W·A·雷扎克 于 2020-04-14 设计创作，主要内容包括：一种外科手术器械,所述外科手术器械具有第一构件,所述第一构件可与紧固件的第一端部接合,所述紧固件的第二端部被配置成穿透组织。第二构件包含可扩展构件,所述可扩展构件被配置成接合所述第一端部。公开了系统和方法。(A surgical instrument having a first member engageable with a first end of a fastener, a second end of the fastener configured to penetrate tissue. The second member includes an expandable member configured to engage the first end. Systems and methods are disclosed.)

1. A surgical instrument, comprising:

an elongated first member having a first end and a second end;

a tubular second member having a third end and a fourth end, a portion of the elongated first member being positioned within the first channel of the tubular second member; and

a tubular third member having a fifth end and a sixth end, the portion of the elongated first member and a portion of the tubular second member being positioned within a second channel of the tubular third member;

wherein the fifth end of the tubular third member comprises a first handle rotatably engaged to a second handle positioned on a portion of the elongate first member to axially translate the tubular third member relative to the tubular second member, and

wherein the first handle is removably coupled to the second handle of the elongated first member.

2. The surgical instrument of claim 1, wherein the fourth end of the tubular second member comprises an expandable member configured to engage an end of a fastener.

3. The surgical instrument of claim 2, wherein the expandable member comprises at least one key portion configured to interlock with at least one key portion disposed on an end of a fastener.

4. The surgical instrument of claim 1, wherein the first handle is configured to rotate in a first direction to translate the sixth end of the tubular third member over the fourth end of the tubular second member.

5. The surgical instrument of claim 4, wherein the first handle is configured to rotate in a second direction to translate the sixth end of the tubular third member away from the fourth end of the tubular second member.

6. The surgical instrument of claim 1, wherein the tubular third member is configured to prevent the tubular second member from moving beyond a distance.

7. The surgical instrument of claim 1, wherein the first handle comprises a receiving portion, and

wherein the second handle comprises a depressible button configured to be inserted into the receiving portion.

8. The surgical instrument of claim 1, wherein the first handle comprises a first receiving portion, and

wherein the second handle includes a depressible button configured to be inserted into the receiving portion, and

wherein the tubular fourth member comprises a third handle comprising a second receiving portion.

9. The surgical instrument of claim 8, wherein the tubular third member is configured to be removed from the elongated first member by pressing the button and removing the tubular third member from the elongated first member, and

wherein the tubular fourth member is configured to be coupled to the elongate first member by inserting the elongate first member into the tubular fourth member and interlocking the depressible button of the second handle with the second receiving portion of the third handle.

10. A surgical instrument, comprising:

an elongated first member having a first end and a second end; and

a tubular second member having a third end and a fourth end, a portion of the elongated first member being positioned within the channel of the tubular second member,

Wherein the third end of the tubular second member comprises a first handle rotatably engaged to a second handle positioned on a portion of the elongate first member to axially translate the tubular second member relative to the elongate first member, and

wherein the first handle is removably coupled to the second handle of the elongated first member.

11. The surgical instrument of claim 1, further comprising a tubular third member having a fifth end and a sixth end,

wherein the portion of the elongated first member is positioned within the channel of the tubular third member, and

wherein a portion of the tubular third member is positioned within the channel of the tubular third member.

12. The surgical instrument of claim 10, wherein the first handle comprises one or more pins, and

wherein the second handle comprises one or more notches configured to engage at least a portion of the one or more pins therein.

13. The surgical instrument of claim 12, wherein the first handle comprises a cavity sized to receive a portion of the second handle.

14. The surgical instrument of claim 13, wherein the one or more pins are circumferentially disposed on an inner surface of the cavity, and

wherein the one or more notches are circumferentially disposed on an outer surface of the second handle.

15. The surgical instrument of claim 12, wherein the tubular second member is configured to be removed from the elongate first member by disengaging the one or more pins of the first handle from the one or more notches of the second handle.

16. The surgical instrument of claim 15, wherein a tubular third member is configured to be coupled to the elongate first member by inserting the elongate first member into the tubular third member and engaging a third handle of the tubular third member with the second handle.

17. The surgical instrument of claim 16, wherein the third handle comprises one or more pins disposed circumferentially on an inner surface of a cavity disposed within the third handle.

18. A surgical system, comprising:

a fastener including at least one key portion disposed on a surface of the fastener;

A surgical tool, the surgical tool comprising:

an elongated first member having a first end and a second end, the first end configured to engage an end of the fastener; and

a tubular second member having a third end and a fourth end, a portion of the elongated first member being positioned within the channel of the tubular second member,

wherein the third end of the tubular second member comprises a first handle rotatably engaged to a second handle positioned on a portion of the elongate first member to axially translate the tubular second member relative to the elongate first member, and

wherein the first handle is removably coupled to the second handle of the elongated first member.

19. The surgical system of claim 18, wherein the first handle comprises one or more pins, and

wherein the second handle comprises one or more notches configured to engage at least a portion of the one or more pins therein.

20. The surgical system of claim 19, wherein the tubular second member is configured to be removed from the elongate first member by disengaging the one or more pins of the first handle from the one or more notches of the second handle, and

Wherein the tubular third member is configured to be coupled to the elongated first member by inserting the elongated first member into the tubular third member and engaging a third handle of the tubular third member with the second handle.

Technical Field

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

Background

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

Non-surgical treatments, such as drug therapy, rehabilitation therapy, and exercise therapy, may be effective, however, may not alleviate symptoms associated with these conditions. Surgical treatment of these spinal disorders includes orthotics, fusions, fixations, discectomies, laminectomies, and implantable prostheses. As part of these surgical treatments, spinal constructs containing implants such as bone fasteners, connectors, plates, and rods are often used to provide stability to the treated area. These implants can redirect stresses away from the damaged or defective area while healing occurs to restore proper alignment and generally support the vertebral members. Surgical instruments are used, for example, to engage fasteners for attachment to the exterior of two or more vertebral members. The present disclosure describes improvements over these prior art techniques.

Disclosure of Invention

In one embodiment, a surgical instrument is provided. The surgical instrument includes a first member engageable with a first end of a fastener, a second end of the fastener configured to penetrate tissue. The second member includes an expandable member configured to engage the first end. In some embodiments, systems and methods are disclosed.

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 a surgical system according to the principles of the present disclosure;

FIG. 2 is a perspective view of the assembly shown in FIG. 1;

FIG. 3 is a perspective view of the assembly shown in FIG. 1;

FIG. 4 is a perspective view of the assembly shown in FIG. 1;

FIG. 4a is an isolated view of the assembly shown in FIG. 1;

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

FIG. 6 is an isolated view of the assembly shown in FIG. 1;

FIG. 7 is an isolated view of the assembly shown in FIG. 1;

FIG. 8 is an isolated view of the assembly shown in FIG. 1;

FIG. 9 is an isolated view of the assembly shown in FIG. 1;

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

FIG. 11 is a perspective view of the assembly shown in FIG. 10;

FIG. 12 is an isolated view of the assembly shown in FIG. 10;

FIG. 13 is an isolated view of the assembly shown in FIG. 10;

FIG. 14 is an isolated view of the assembly shown in FIG. 10;

FIG. 15 is an end view of the components of the surgical system shown in FIG. 10;

FIG. 16 is a perspective view of components of a surgical system incorporating a first sleeve according to the principles of the present disclosure;

FIG. 17 is an isolated view of the surgical system shown in FIG. 16 including a second sleeve;

FIG. 18A is a perspective view of a first sleeve of the surgical system; FIG. 18B is a perspective view of a second sleeve of the surgical system;

FIG. 19 is an isolated view of the surgical system shown in FIG. 16 including the first sleeve;

FIG. 20A is a perspective view of components of the surgical system shown in FIG. 16; FIG. 20B is a cross-sectional view of components of the surgical system shown in FIG. 16;

FIG. 21 is a cross-sectional view of the assembly shown in FIG. 16;

FIG. 22 is a cross-sectional view of the assembly shown in FIG. 16;

23A-23C are perspective views of components of the surgical system illustrated in FIG. 16;

FIG. 24A is a cross-sectional view of an alternative component to the component shown in FIG. 16;

24B-24C are perspective views of alternative components to the component shown in FIG. 16;

FIGS. 24D-24G are perspective views of alternative components to the component shown in FIG. 16;

FIG. 25 is a perspective view of a sleeve of the surgical system; and is

Fig. 26 is a perspective view of components of another surgical system according to the principles of the present disclosure.

Detailed Description

Exemplary embodiments of the surgical system are discussed from the perspective of a medical device for treating musculoskeletal disorders, and more particularly from the perspective of a surgical system and method for treating the spine. In some embodiments, the systems include surgical instruments and related methods of use that can be used with spinal constructs that include bone fasteners and connectors with pop-up, snap-fit, click and/or slide members that provide a universal connection system to the spinal surgeon. In some embodiments, the spinal construct allows for the use of a single bone screw assembly with multiple types of receivers, thereby minimizing inventory while creating a customized patient-specific assembly.

In some embodiments, the system includes a surgical instrument and associated method of use that may be used with a bone screw shank that is not pre-coupled to a tulip-shaped (tulip) head. In some embodiments, such bone screws without a pre-coupled tulip head allow for modular implant selection in the operating room with minimal inventory and can provide spinal rod receiver attachment in situ.

In one embodiment, the system includes a surgical instrument, such as a bone screw driver configured to drive a bone screw shank without a tulip head. In one embodiment, the system includes a driver configured to provide secure engagement with a bone screw that does not have a conventional tulip head or other type of spinal rod receiver member. In one embodiment, the system includes a driver having an inner sleeve with a flexible collet. In one embodiment, the system includes a driver having a flexible collet configured to snap around a spherical head of a bone screw by pushing down an outer sleeve configured to force an inner sleeve downward. In one embodiment, the system includes a driver having an inner sleeve and an outer sleeve coupled together by a threaded interface and configured for relative translation from a first open position to a second closed position.

In one embodiment, the system includes a driver having an outer sleeve configured to prevent the flexible collet from expanding in a closed position and to allow disengagement from the bone screw in an open position. In one embodiment, the system includes a driver having an outer sleeve configured to be disposed within the outer sleeve

A force is applied to the retaining cap of the drive shaft as the outer sleeve translates. In one embodiment, the system includes a driver having an outer sleeve configured to translate to apply a compressive force between a bone screw and a collet to secure the screw to the driver to reduce wrist between the bone screw and a drive shaft.

In one embodiment, the system includes a driver having a tip that mimics the shape of a tulip head and provides a hard stop to prevent the bone screws from screwing too deep. In one embodiment, the system includes a driver having a tip that is a reamer configured to drill a passage to allow the tulip head to be engaged without interference from the patient's anatomy.

In one embodiment, the system includes a surgical instrument, such as a driver. In some embodiments, the driver has an outer sleeve with an outer sleeve. In some embodiments, the outer sleeve has a handle configured to rotate relative to the outer sleeve. In some embodiments, the driver has an inner sleeve and a drive shaft with an oriented pin. In some embodiments, the driver has a retainer cap. In one embodiment, the system includes a driver having a threaded handle configured to translate an outer sleeve and apply a compressive force between a bone screw and the inner sleeve. In one embodiment, the system includes a driver having a reamer tip. In one embodiment, the system includes a driver having a collet on an inner sleeve configured to snap over a ball of a bone screw.

In one embodiment, the system includes a driver having a tip configured to mimic a tulip head and prevent bone screws from being driven too deep into the patient's anatomy to allow the tulip head to attach. In one embodiment, the driver has a collet on the inner sleeve.

In one embodiment, the system includes a driver that provides a secure and rigid connection between bone screws or receiver assemblies without tulip heads. In one embodiment, the system includes a driver that facilitates use of an implant system in which a tulip head may be attached to a bone screw.

In one embodiment, the system includes an instrument having a collar that slides over a spherical head of a fastener. In one embodiment, the system includes an instrument having three sleeves. In one embodiment, the system includes an instrument having an inner shaft configured as a driver. In one embodiment, the system includes an instrument having a combination of two sleeves disposed around the exterior of the driver. In one embodiment, the instrument includes a driver configured to extend beyond the sleeve such that an end of the driver extends beyond an end of the sleeve to reach the fastener. In one embodiment, the system includes an instrument having a sleeve configured to translate over a top of the fastener and rotate in threaded engagement with a second sleeve to lock the instrument. In one embodiment, the system includes an instrument configured to prevent the fastener from penetrating too deeply into tissue to allow the implant to be coupled with the head of the fastener. In one embodiment, the system includes an instrument having a distal end of a sleeve configured to replicate the geometry of the fastener receiver to facilitate connection of the fastener receiver with the fastener head. In one embodiment, the system includes an instrument having a diameter at the end of the outer sleeve similar to the tulip receiver diameter of the fastener.

In some embodiments, the systems of the present disclosure may be used to treat spinal disorders such as degenerative disc disease, disc herniations, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and bone fractures. In some embodiments, the systems of the present disclosure may be used with other bone and bone related applications, including those related to diagnosis and treatment. In some embodiments, the disclosed systems may alternatively be used to surgically treat a patient in a prone or supine position, and/or to employ various surgical approaches to the spine, including anterior, posterior, posteromedial, direct lateral, posterolateral and/or anterolateral approaches, as well as in other body regions. The system of the present disclosure may also be used alternatively with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of the spine. The systems of the present disclosure may also be used on animals, bone models, and other non-biological substrates, for example, in training, testing, and demonstration.

The 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 this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or illustrated 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. Furthermore, in some embodiments, as used in the specification and 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, such as horizontal, vertical, top, upper, lower, bottom, left side, and right side, 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 only used in context with one another, and not necessarily "upper" and "lower".

Further, as used in the specification, and 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 (human, normal or non-normal human, or other mammal), employing an implantable device, and/or employing a device for treating the disease, such as a mini-discectomy device for removing a bulge or herniated disc and/or bony spur, in an effort to alleviate signs or symptoms of the disease or condition. Remission can occur before and after the appearance of signs or symptoms of a disease or condition. Thus, treating or treating includes preventing or preventing a disease or an undesirable condition (e.g., preventing the disease from occurring in a patient who may be predisposed to the disease but has not yet been diagnosed as having the disease). Furthermore, the treatment or therapy does not require complete relief of signs or symptoms, does not require a cure, and specifically involves surgery that has only marginal effect on the patient. Treatment may comprise inhibiting the disease, e.g. arresting its development, or ameliorating the disease, e.g. causing regression of the disease. For example, treatment may comprise reducing acute or chronic inflammation; relief of pain and reduction and induction of regeneration of new ligaments, bone and other tissues; as an aid in surgery; and/or any revision surgery. Furthermore, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically stated otherwise.

The following discussion includes a description of a surgical system including surgical instruments, related components, and methods of employing a 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. 1-9, the components of a surgical implant system 10 in accordance with the principles of the present disclosure are illustrated.

The components of the 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, individually or collectively, the components of system 10 may be made from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (e.g., nitinol, superelastic plastic metals such as GUM manufactured by Toyota materials, Japan)

) Ceramics and composites thereof, such as calcium phosphate (e.g., SKELITETM manufactured by Biologic Inc., ltd.), thermoplastics, such as Polyaryletherketones (PAEKs), including Polyetheretherketones (PEEK), Polyetherketoneketones (PEKK), and Polyetherketones (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, 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 cancellous bone, and tissue growth or differentiation factors, partially resorbable materials, e.g. metal and calcium-based ceramic composites, PEEK and resorbable polymer composites, fully resorbable materials, e.g. calcium-based ceramics, such as calcium phosphate, tri-phosphate Calcium (TCP), Hydroxyapatite (HA) -TCP, calcium sulfate or other resorbable polymers such as polyketone (polyactide), polyglycolide, poly tyrosine carbonate, polycaprolactone (polycarophyloethohe) and combinations thereof. The various components of the system 10 may have a material composite, including the materials described above, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical properties, durability and radiolucency or imaging preference. Individually or collectively, the components of the system 10 may also be made of heterogeneous materials, such as a combination of two or more of the above-mentioned materials. As described herein, the components of the system 10 may be integrally formed, integrally connected, or contain fastening elements and/or instruments.

The system 10 including the surgical instrument 12 is used, for example, in open or mini open procedures, minimally invasive procedures, and/or minimally invasive procedures including percutaneous surgical techniques to deliver and secure an implant at a surgical site (e.g., a segment of the spine) within a patient. In one embodiment, the components of system 10 are configured to secure bone fasteners with tissue for surgical treatment to treat various spinal pathologies such as those described herein.

As shown in fig. 4-5, the system 10 includes a surgical instrument 12 that includes a member, such as a drive shaft 14, extending along an axis L between an end 18 and an opposite end 20. The end 18 includes a mating surface 22 configured to facilitate manipulation and/or manipulation of the surgical instrument 12. The surface 22 is configured to engage with a retaining cap 24. In one embodiment, the drive shaft 14 includes a surface 26 defining a cavity 28 configured to receive an orientation pin 29.

As shown in fig. 5, end 20 is configured to engage an implant (e.g., bone fastener 82). In some embodiments, the end 20 can have a different cross-section, such as square, hexagonal, polygonal, triangular, star-shaped, or hexalobal (hexalobe). The end 20 may have various surface configurations, such as smooth, rough, arcuate, wavy, porous, semi-porous, concave, polished, and/or textured.

A member, such as a sleeve 30, is configured to seat the drive shaft 14. Sleeve 30 extends along axis L between ends 32 and 34. The sleeve 30 includes an inner surface 36 and an outer surface 38. The surface 36 defines a channel 40 coaxial with the axis L and configured to house the drive shaft 14. As described herein, the surface 38 includes a threaded portion 39 configured to engage with a third member. The end 34 contains an expandable member, such as a collet 42.

As described herein, the collet 42 extends from the end 34 and is configured to move between a first configuration and a second configuration. As shown in fig. 6-9, the collet 42 includes an inner surface 44 that defines a passage 46. The passage 46 is coaxial with the passage 40. The passage 46 has a cylindrical cross-sectional configuration. In some embodiments, the channels 46 may have various cross-sectional configurations, such as oval, rectangular, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and/or tapered.

The collet 42 includes a locking surface 48 defined by a plurality of radially outwardly extending cantilevered fingers 50. The fingers 50 are circumferentially disposed and equally spaced. The fingers 50 are spaced apart by a gap 52 defined by opposed planar side walls 54. As described herein, in one embodiment, the collets 42 are flexible such that the collets 42 are biased in the first closed position. The collet 42 is configured to snap fit around a first end, such as the head 84 of the fastener 82. As the collet 42 translates over the head 84 of the fastener 82, the collet 42 moves from the first closed position to the second open position and returns to the first closed position to capture the head 84.

The system 10 includes a third component, such as a sleeve 60. Sleeve 60 extends along axis L between ends 62 and 64. The sleeve 60 includes an inner surface 66 and an outer surface 68. The surface 66 defines a channel 70 coaxial with the axis L and configured to movably seat the sleeve 30. In one embodiment, the inner surface 66 may have various surface configurations to enhance engagement of the sleeve 30 and/or the collet 42, such as rough, arcuate, wavy, porous, semi-porous, concave, polished, and/or textured.

As described herein, end 62 includes a handle 72 having a threaded inner surface 74 configured to rotatably engage threaded portion 39 to axially translate sleeve 60 relative to sleeve 30, which results in a releasable locking of collet 42 with bone fastener 82. End 64 includes a tip 76 that defines a reamer end surface 78. The reamer end surface 78 includes a plurality of teeth 80 configured to drill a passage around the head 84. In one or more instances, the teeth 80 are angled to cut in the direction of rotation of the reamer end surface 78. In one or more other instances, the teeth 80 may be bi-directionally angled such that the teeth 80 may dig into tissue disposed about the head 85 in a clockwise direction and/or a counter-clockwise direction. In one or more instances, the teeth 80 are configured to rotate independently of the sleeve 60 such that the teeth rotate independently of the elongate shaft 86.

As discussed herein, the sleeve 60 is configured to lock the collet 42 with the head 84 for releasable fixation with the bone fastener 82. The sleeve 60 extends along a portion of the sleeve 30 and is configured to axially translate relative to the sleeve 30. As the sleeve 60 is axially translated in the direction indicated by arrow E in fig. 9, the fingers 50 are driven further inward by the force of the sleeve 60 engaging the collet 42 so that the fingers 50 can move to a locked position around the head 84 with the locking surface 48.

System 10 includes a fastener, such as bone fastener 82. The fastener 82 includes a head 84 configured to engage the drive shaft 14 and an elongate shaft 86 configured to penetrate tissue. The head 84 comprises a spherical configuration. The head 84 includes an outer circumferential surface 88 having a substantially uniform diameter therearound. In some embodiments, all or only a portion of surface 88 comprises a spherical configuration. The head 84 includes an inner surface 90, such as a mating surface 92, that defines a cavity. As discussed herein, the mating surface 92 is configured to seat an instrument and/or tool extension, such as the end 20 of the drive shaft 14. The mating surface 92 is centrally located with respect to the head 84. The mating surface 92 is coaxial with the axis L. In some embodiments, the mating surface 92 may have various cross-sectional configurations, such as oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and/or tapered. In some embodiments, the inner surface 90 may have various surface configurations, such as smooth and/or surface configurations, to enhance engagement with a mating surface of the drive shaft 14, such as rough, arcuate, contoured, porous, semi-porous, concave, polished, and/or textured.

The shaft 86 has a cylindrical cross-sectional configuration and includes an outer surface having the form of external threads. In some embodiments, the thread form may comprise a single turn of thread or multiple discrete turns of thread. In some embodiments, other engagement structures may be disposed on the shaft 86, such as staple arrangements, barbs, spreading elements, raised elements, and/or spikes, to facilitate engagement of the shaft 86 with tissue, such as vertebrae.

In some embodiments, all or only a portion of the shaft 86 may have alternative cross-sectional configurations, such as oval, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, deformable, and/or tapered. In some embodiments, the outer surface may include one or more openings. In some embodiments, all or only a portion of the outer surface may have alternative surface configurations to enhance fixation to tissue, such as rough, arcuate, wavy, reticulated, porous, semi-porous, concave, and/or textured. In some embodiments, all or only a portion of shaft 86 may be disposed at alternative orientations relative to the longitudinal axis of bone fastener 82, such as laterally, vertically, and/or other angular orientations, such as acute or obtuse angles, coaxial, and/or may be offset or staggered. In some embodiments, all or only a portion of the shaft 86 may be cylindrical.

As discussed herein, in assembly, operation, and use, a surgical implant system 10 similar to the systems and methods described herein is employed with a surgical procedure for treating a spinal disorder affecting a spinal column segment of a patient. For example, the system 10 may be used with a surgical procedure for treating a pathology or injury to an affected section of the spine containing vertebrae. In some embodiments, one or all of the components of the system 10 may be delivered as a pre-assembled device, or may be assembled in situ. The system 10 may be modified, removed, or replaced, in whole or in part.

For example, the system 10 may be used in a surgical procedure to treat applicable pathologies or injuries of the spine and affected sections of adjacent regions (e.g., vertebrae) (not shown) within the body. In some embodiments, system 10 may be used for one or more vertebrae. To treat a selected section of a vertebra, a medical practitioner gains access to the surgical site containing the vertebra in any suitable manner (e.g., by incision and retraction of tissue). In some embodiments, the system 10 may be used with any existing surgical method or technique, including open surgery, mini open surgery, minimally invasive surgery including percutaneous surgical implantation, whereby a vertebra is accessed through a micro-incision or sleeve providing a protected channel to a region. Once access to the surgical site is obtained, specific surgical procedures may be performed to treat the spinal disorder.

An incision is cut in the patient and a cutting instrument (not shown) creates a surgical pathway for the implantable components of the delivery system 10. Preparation instruments (not shown) may be used to prepare the vertebrae and the tissue surfaces for aspiration and irrigation of the surgical field.

The surgical instrument 12 may be placed in the first position with the collet 42 in a biased closed position extending a distance from the end 64 of the sleeve 60. The end 20 of the drive shaft 14 engages the mating surface 92. Rotation of handle 72 in the direction indicated by arrow a in fig. 5 causes sleeve 30 to translate along axis L in the direction indicated by arrow B in fig. 8, thereby causing collet 42 to capture head 84. As fingers 50 translate over surface 88, fingers 50 of collet 42 expand to a second position in the direction indicated by arrow C in fig. 8. As finger 50 translates over surface 88, finger 50 is urged to the first position by moving in the direction shown by arrow D in fig. 8 due to the resilient bias of finger 50 to snap fit around head 84, thereby capturing head 84 within finger 50. Locking surface 48 is in contact with surface 88. Further rotation of handle 72 causes sleeve 60 to translate in the direction indicated by arrow E in fig. 9, translating end 76 of sleeve 60 over collet 42 and compressing fingers 50 of collet 42 and tightening fingers 50 around surface 88 of head 84 to releasably secure surgical instrument 12 with fastener 82.

Translation of the sleeve 60 causes the teeth 80 of the reamer end surface 78 to dig into the tissue disposed about the head 85. In some embodiments, the reamer end surface 78 creates a circumferential path around the head 84, providing space for an implant, such as a spinal rod receiver, connected to the head 84.

The drive shaft 14 is rotated to apply a torsional force to the bone screw 82 and increase the depth of the pilot hole and/or tighten the bone screw 82 with tissue. As the overall depth of the guide hole increases, the shaft 86 engages the outer layer of cortical bone such that further rotation of the bone screw 82 about the axis L causes the shaft 86 to move through the guide hole and the outer layer of cortical bone and into the cancellous bone layer. In some embodiments, bone screw 82 is rotated until the shaft of bone screw 82 penetrates the vertebra to fix bone screw 82 with the tissue.

The assembly of system 10 including surgical instrument 12 and bone screw 82 is used to augment one or more surgical treatments. As described herein, the surgical instrument 12 may be disposed in a first, non-locking orientation to release the bone screw 182 from the collet 60. To disengage the instrument 12 from the fastener 82, the handle 72 is rotated in the opposite direction indicated by arrow F in FIG. 5 to translate the sleeve 60 in the direction indicated by arrow G, thereby releasing the compressive force about the collet 42. Rotation of handle 72 causes sleeve 30 to translate in the direction indicated by arrow H in fig. 8 to translate finger 50 away from head 84, thereby disengaging finger 50 from head 84. Disengaging the end 20 of the drive shaft 14 from the mating surface 92.

The surgical instrument 12 may be reassembled for surgical procedures. In some embodiments, the system 10 may include various instruments, including the locking and collet configurations of the present disclosure, such as inserters, dilators, microsclers, dilators, distractors, blades, distractors, clamps, forceps, lifters (elevators), and drill bits, which may alternatively be sized and dimensioned, and arranged in a kit.

After the procedure is completed, the surgical instrument 12, surgical instruments and/or tools, assemblies, and non-implanted components of the system 10 are removed and one or more incisions are closed. One or more of the components of the 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 system 10, the use of surgical navigation, microsurgery, and image guidance techniques may be used to access, view, and repair spinal degeneration or injury. In some embodiments, the system 10 may include one or more plates, connectors, and/or bone fasteners for use with a single vertebral level or multiple vertebral levels.

In one embodiment, as shown in fig. 10-15, a spinal implant system 10, similar to the systems and methods described herein, includes an instrument 12 described herein having a drive shaft 14, a sleeve 30, and a sleeve 160 similar to the sleeve 60 described herein. The drive shaft 14 extends along an axis L between an end 18 and an opposite end 20.

As shown in fig. 10, end 20 is configured to engage bone fastener 82. The sleeve 30 is configured to house the drive shaft 14. The sleeve 30 extends along an axis L. The sleeve 30 includes a passage 40 coaxial with the axis L and configured to house the drive shaft 14. As described herein, the sleeve 30 includes a collet 42. As described herein, the collet 42 is configured to move between a first configuration and a second configuration. As shown in fig. 12-13, the collet 42 includes an inner surface 44 that defines a passage 46. The passage 46 is coaxial with the passage 40.

Sleeve 160 extends axially between end 162 and end 164. The sleeve 160 includes an inner surface 166 and an outer surface 168. The surface 166 defines a channel 170 coaxial with the axis L and configured to movably seat the sleeve 30.

End 162 includes a handle 172 having a threaded inner surface (not shown) similar to threaded surface 74. As described herein, the threaded surface is configured to rotatably engage the threaded portion 39 to axially translate the sleeve 160 relative to the sleeve 30, which results in the releasable locking of the collet 42 with the bone fastener 82. As shown in fig. 12, the end 164 is sized and/or configured similar to a tulip-shaped head receptacle. The end 164 includes a diameter similar to the diameter of the tulip-shaped head receptacle. The end 164 defines a cavity configured to receive the collet 42 and the head 84 such that the end 164 is disposed about the head 84 and the collet 42 such that a space is disposed about the head 84 for connection of a receiver.

As discussed herein, the sleeve 160 is configured to lock the collet 42 with the head 84 for releasable fixation with the bone fastener 82. The sleeve 160 extends along a portion of the sleeve 30 and is configured to translate axially relative to the sleeve 30. As the sleeve 60 is axially translated in the direction indicated by arrow I in fig. 14, the fingers 50 are driven inward by the force of the sleeve 160 engaging the collet 42 so that the fingers 50 can move to a locked position around the head 84 with the locking surface 48.

End 164 includes a hard stop portion 178 configured to prevent penetration of fastener 82 into tissue beyond a selected limit. The hard stop portion 178 allows the receiver to be connected with the head 84.

In one embodiment, as shown in fig. 16-26, surgical implant system 200 includes one or more of the same or similar features as described herein with respect to system 10. One or more of the materials described with respect to system 10 may be used to fabricate and/or form components of system 200. Therefore, the description of these materials will not be repeated.

The system 200 including the surgical instrument 210 is used, for example, in open or mini open surgery, minimally invasive surgery, and/or minimally invasive surgery including percutaneous surgical techniques to deliver and secure an implant at a surgical site within a patient (e.g., a section of the patient's spine). In one embodiment, the components of system 200 are configured to secure bone fasteners, such as bone fastener 222, for surgical treatment to treat various spinal pathologies, such as those described herein.

As shown in fig. 20A and 20B, system 200 includes a fastener, such as bone fastener 222. The fastener 222 includes a head 238 configured to engage the drive shaft 202 and an elongate shaft 252 configured to penetrate tissue. The head 238 includes a spherical configuration. Head 238 includes an outer circumferential surface 278 having a substantially uniform diameter therearound. In some embodiments, all or only a portion of surface 278 includes a spherical configuration. The head 238 includes an inner surface 280, such as the mating surface 254, that defines a cavity. As discussed herein, the mating surface 254 is configured to seat an instrument and/or tool extension, such as the mating surface 208a on the end 208 of the drive shaft 202. The mating surface 254 is centrally located with respect to the head 238. Mating surface 254 and axis L₁And (4) coaxial. In some embodiments, the mating surface 254 may have various cross-sectional configurations, such as oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and/or tapered. In some embodiments, the inner surface 280 may have various surface configurations, such as smooth and/or surface configurations, to enhance engagement with the mating surface 208a of the drive shaft 202, such as rough, arcuate, contoured, porous, semi-porous, concave, polished, and/or textured.

The shaft 252 of the fastener 222 has a cylindrical cross-sectional configuration and includes an outer surface having an external thread form. In some embodiments, the thread form may comprise a single turn of thread or multiple discrete turns of thread. In some embodiments, other engagement structures may be disposed on the shaft 252, such as staple arrangements, barbs, spreading elements, raised elements, and/or spikes, to facilitate engagement of the shaft 252 with tissue, such as vertebrae.

In some embodiments, all or only a portion of the shaft 252 may have alternative cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, deformable, and/or tapered. In some embodiments, the outer surface may include one or more openings. In some embodiments, all or only a portion of the outer surface may have alternative surface configurations to enhance fixation to tissue, such as rough, arcuate, wavy, reticulated, porous, semi-porous, concave, and/or textured. In some embodiments, all or only a portion of the shaft 252 may be relative to the longitudinal axis L of the bone fastener 222 ₁In alternative orientationsAre disposed, e.g., laterally, vertically, and/or at other angular orientations, such as acute or obtuse, coaxial, and/or may be offset or staggered. In some embodiments, all or only a portion of the shaft 252 may be cylindrical.

In one or more embodiments, the outer circumferential surface 278 of the head 238 includes one or more screw flats, such as screw flat 240a and screw flat 240 b. As discussed herein, the screw flats 240a may be configured in a geometry that matches the key portions (e.g., key portions 242a and 242b) of the collet 236. In one or more instances, the keyed surface 286 of the screw flat 240a may be recessed into the outer circumferential surface 278 of the head 238. In one or more other instances, the key surface 286 of the screw flat 240a may protrude from the outer circumferential surface 278 of the head 238. The keyed surface 286 of the screw flat 240a may have a planar shape. The keyed surface 286 of the screw flat 240a may extend across the outer circumferential surface 278 of the head 238. It should be noted that screw flat 240b contains one or more of the same or similar features as screw flat 240 a. Accordingly, the description of such features of the screw plane 240b is not repeated. It should also be noted that two screw planes are depicted; however, embodiments are contemplated in which the head 238 includes one screw flat and in which the head 238 includes more than two screw flats (e.g., four screw flats), in which the collet 236 includes a corresponding number of key portions (e.g., four key portions).

As shown in fig. 16 and 19, system 200 includes a surgical instrument 210 that includes a member, such as along axis L, between end 204 and opposite end 208₁An extended drive shaft 202. End 204 includes a mating surface 206 configured to facilitate manipulation and/or manipulation of a surgical instrument 210. Surface 206 is configured to engage with a handle. The handle may have a receiving portion on an inner surface of the handle, wherein a surface of the receiving portion is configured to receive the end 204 of the drive shaft 202.

The drive shaft 202 may be an elongated rigid member having a solid center. The drive shaft 202 may include a stop 296 disposed about an outer surface of the shaft 202. The stop 296 may be a rigid body having a bushing 296a positioned on one end of the stop 296 and projecting outwardly from the shaft 202. The stop 296 may have a cylindrical disk 296b positioned on an end of the stop 296 opposite the bushing 296 a.

As shown in fig. 19, the bushing 296a and the cylindrical disk 296b may be positioned on the shaft 202 a set distance from each other to prevent the shaft 202 from translating beyond the set distance through the sleeves 216 and 218. For example, the bushing 296a may contact the outer surface 298 of the knob 214 and may prevent the drive shaft 202 from moving a set distance toward the end 270. In another example, the cylindrical disc 296b may contact an inner surface of the knob 214 and prevent the drive shaft 202 from moving a set distance away from the end 270. In one or more instances, the knob 214 may rotate about the drive shaft 202 and may translate over the drive shaft 202 relative to the distance defined by the bushing 296a and the cylindrical disk 296 b. In one or more instances, the bushing 296a may be used to facilitate connection of the surgical instrument 210 to a navigation tracking instrument, such as a NavLock available from Medtronic, Inc ^TMA tracker. As shown in FIG. 24A, the navigation tracking instrument may be coupled to the recessed portion 296c of the bushing 296 a.

As shown in fig. 16, a mating surface 208a on the end 208 is configured to engage an implant, such as a bone fastener 222. In some embodiments, the end 208 may be formed with different cross-sectional shapes, such as, but not limited to, square, hexagonal, polygonal, triangular, star-shaped, or preferably hexalobal. The mating surface 208a may have various surface configurations, such as smooth, rough, arcuate, contoured, porous, semi-porous, concave, polished, and/or textured. The mating surface 208a may be formed in a shape that is insertable into the mating surface 254 of the fastener 222.

The drive shaft 202 may be inserted through the passage 232 of a member, such as the sleeve 216. The sleeve 216 may be configured to seat the drive shaft 202. The sleeve 216 may be an elongated tubular member having a cylindrical center forming the passage 232. Sleeve 216 extends along axis L between end 224 and end 226₁And (4) extending. The sleeve 216 includes an inner surface 228 and an outer surface 230. Surface 228 defines an axis L₁Coaxial and configured to seat the passage 232 of the drive shaft 202. Surface 230 comprisesA threaded portion 234 configured to engage a third member, such as the sleeve 218 and preferably the knob 220 of the sleeve 218. End 226 includes an expandable member, such as collet 236.

As described herein, the collet 236 extends from the end 226 and is configured to move between an open position and a closed position. As shown in fig. 20A-20B, the collet 236 includes an inner surface 260 that defines a passage 262. The passage 262 is coaxial with the passage 232. The passage 262 has a cylindrical cross-sectional configuration. In some embodiments, the channel 262 can have various cross-sectional configurations, such as oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and/or tapered.

The collet 236 may be configured to snap fit around the head 238 of the fastener 222. As the collet 236 translates over the head 238 of the fastener 222, the collet 236 moves from the closed position to the open position and returns to the closed position to capture the head 238. The collet 236 may be snap-fit around the head 238 of the fastener 222 by a plurality of cantilevered fingers 250a, 250b, 250c, and 250 d. The plurality of cantilevered fingers 250a, 250b, 250c, and 250d may define an inner surface 260 of the collet 236 that serves as a locking surface. The fingers 250a, 250b, 250c, and 250d may extend radially outward from the end 226 of the sleeve 216. The fingers 250a, 250b, 250c, and 250d may be circumferentially disposed and equally spaced apart. Fingers 250a, 250b, 250c, and 250d are spaced apart by a gap 264 defined by opposing planar sidewalls 266. The distal ends of the fingers 250a, 250b, 250c, and 250d may include a first surface 284 configured to engage the outer circumferential surface 278 of the head 238. The first surface 284 may taper toward the distal ends of the fingers 250a, 250b, 250c, and 250 d. The distal ends of fingers 250a, 250b, 250c, and 250d may include a second surface 282 integrally connected with first surface 284. The second surface may taper away from the distal ends of fingers 250a, 250b, 250c, and 250 d. It should be noted that collet 236 is depicted as having four fingers; however, embodiments are contemplated in which collet 236 includes less than four fingers and in which collet 236 includes more than four fingers.

In one embodiment, collet 236 is flexible such that fingers 250a, 250b, 250c, and 250d are configured to move from a closed position to an open position and from an open position to a closed position. Fig. 20A shows the collet 236 biased in the position. Fig. 20B shows the collet 236 fitted around the head 238 of the fastener 222 in the first, closed position. In the closed position, the fingers 250a, 250b, 250c, and 250d may be cantilevered from the end 226 of the sleeve 216 such that the fingers 250a, 250b, 250c, and 250d extend parallel or substantially parallel to the inner surface 228 and/or the outer surface 230 of the sleeve 216. In the open position, the fingers 250a, 250b, 250c, and 250d may flex outward away from the center of the channel 232.

In one example, the collets 236 may be biased in the closed position. In one or more instances, the user may insert the mating surface 208a of the drive shaft 202 into the mating surface 254 of the fastener 222. The user may then begin to position the head 238 of the fastener 222 within the collet 236 of the sleeve 216. As the collet 236 translates over the head 238 of the fastener 222, the first surface 284 of one or more of the fingers 250a, 250B, 250C, and 250d contact the outer circumferential surface 278 of the head 238 and flex outwardly away from the center of the channel 232 in the direction C shown in fig. 23B, thereby moving the collet 236 to the open position. The tapered portion of the first surface 284 may facilitate translation of the fingers 250a, 250b, 250c, and 250d of the head 238. After passing the first surface 284, the outer circumferential surface 278 of the head 238 contacts the second surfaces 282 of one or more of the fingers 250a, 250b, 250c, and 250 d. As second surface 282 translates over head 238, fingers 250a, 250B, 250c, and 250D flex inward toward the center of channel 232 in direction D shown in fig. 23B, thereby returning collet 236 to the closed position and coupling fastener 222 to instrument 210.

In one or more embodiments, one or more of the fingers 250a, 250b, 250c, and 250d includes a key portion, such as key portion 242a and key portion 242 b. The key portion 242a may be configured in a geometry that matches the screw flat 240a of the fastener 222. The collet 236 may include a number of key portions equal to the number of screw flats of the fastener 222. The key portion 242a may include a surface that extends across the inner surface 260 of the collet 236. In one or more instances, a surface of the key portion 242a can protrude from the inner surface 260 of the cartridge 236, forming a recess. For the case where the keyed surface 286 of the screw plane 240a is notched, the raised surface of the key portion 242a may be configured to engage the keyed surface 286 of the screw plane 240 a. In one or more other instances, the surface of the key portion 242a may be a surface recessed into the inner surface 260 of the collet 236 to form a cavity. For the case where the keyed surface 286 protrudes from the outer circumferential surface 278 of the head 238, the recessed surface of the key portion 242a may be configured to engage the keyed surface 286 of the screw plane 240 a. The surface of the key portion 242a may have a different shape, e.g., a planar shape, than the inner surface 260 of the collet 236. In one or more instances, the key portion 242a can be disposed entirely on one of the fingers 250a, 250b, 250c, and 250 d. In one or more other instances, as shown in fig. 20A, a portion of the key portion 242a can be disposed on a portion of one finger (e.g., finger 250b) and another portion of the key portion 242a can be disposed on a portion of an adjacent finger (e.g., 250 c).

It should be noted that key portion 242b includes one or more of the same or similar features as key portion 242 a. Therefore, the description of such features of the key portion 242b is not repeated. It should also be noted that two key portions are described; however, embodiments are contemplated in which collet 236 includes one key portion and in which collet 236 includes more than two key portions.

As shown in fig. 17, the system 200 includes a third component, such as a sleeve 218. Sleeve 218 is between ends 268 and 270 along axis L₁And (4) extending. The sleeve 218 includes an inner surface 274 and an outer surface 272. The inner surface 274 defines an axis L₁Coaxially and configured to movably seat the passage 276 of the sleeve 216. In one embodiment, the inner surface 274 may have various surface configurations to enhance engagement of the sleeve 216 and/or the collet 236, such as rough, arcuate, wavy, porous, semi-porous, concave, polished, and/or textured.

As shown in fig. 21, surgical operationThe instrument 210 may include a translation stop 288. Translation stop 288 may be configured to limit the distance sleeve 216 may translate axially through sleeve 218, such as distance D₁. Further, translation stops 288 may be configured to prevent axial rotation of sleeve 216 within sleeve 218. The translation stop 288 may include one or more rails (e.g., rail 248a and rail 248b), and one or more pins (e.g., pins 246a and 246 b). As shown in fig. 19 and 21, in one or more instances, the track 248a and the track 248b can each be disposed on the sleeve 216, and the pin 246a and the pin 246b can each be disposed on the sleeve 218. In one or more other instances, the track 248a and the track 248b can be disposed on the sleeve 218, and the pin 246a and the pin 246b can be disposed on the sleeve 216.

For the case where the tracks 248a and 248b are disposed on the sleeve 216, the tracks 248a and 248b may be through-holes extending from the outer surface 230 of the sleeve 216 to the inner surface 228 of the sleeve 216. The tracks 248a and 248b may be sized to receive the pins 246a and 246b, respectively. For the case where pins 246a and 246b are positioned on sleeve 218, pins 246a and 246b may protrude into channel 276. The pins 246a and 246b may be positioned on the sleeve 218 such that the pins 246a and 246b may be positioned within the tracks 248a and 248b, respectively. The pins 246a and 246b may protrude far enough into the channel 276 to contact at least a portion of the stop surfaces 292a and 292b of the rails 248a and 248 b. The pins 246a and 246b may protrude far enough into the channel 276 to contact at least a portion of the stop surfaces 294a and 294b of the rails 248a and 248 b. The pins 246a and 246b may protrude far enough into the passage 276 not to interfere with the movement of the drive shaft 202 within the passage 232.

In one or more instances, the pins 246a and 246b and the stop surfaces 292a and 292b are configured to prevent the sleeve 216 from moving beyond the set distance D₁. For example, as sleeve 216 translates through sleeve 218, sleeve 216 may move a distance D toward the distal end of surgical instrument 210 ₁. Has moved by a distance D₁Thereafter, the stop surfaces 292a and 292b contact the pins 246a and 246b, respectively, thereby limiting the distance the sleeve 216 axially translates through the sleeve 218.

In one or more instances, end 270 of sleeve 218 can act as a depth stop to prevent fastener 222 from penetrating into the body (e.g., vertebral body of the spine) beyond distance D₂. In one or more instances, distance D₂Can range from equal to or about 3.5 millimeters (mm) to equal to or about 5 mm. More preferably, the distance D₂May be equal to or about 4 mm. End 270 of sleeve 280 may be configured to surround proximal threads 295f of fastener 222. In one or more instances, by surrounding a portion of threads 295f, when fastener 222 is secured, for example, in a vertebral body, and collet 236 is retracted within end 270, outer surface 295d of end 270 can contact the outer surface of the vertebral body, thereby preventing further penetration of fastener 222 into the vertebral body. That is, when outer surface 295d of end 270 of sleeve 218 contacts the outer surface of the vertebral body, surgical instrument 210 is prevented from inserting full insertion depth 295e of fastener 222 into the vertebral body. In one or more instances, the distance between the outer surface 295a of the collet 236 and the inner surface 295b of the end 270 of the sleeve 218 can define the length of the proximal threads 295f that can be surrounded by the end 270 of the sleeve 218.

In one or more instances, the end 268 of the sleeve 218 includes a knob 220 attached thereto, the knob having a threaded inner surface 258. The threaded inner surface 258 of the knob 220 may be configured to rotatably engage the threaded portion 234 of the sleeve 216. Knob 220 and sleeve 218 may be rotatably coupled with sleeve 216 by threading threaded inner surface 258 with threaded portion 234.

As discussed herein, the sleeve 218 is configured to lock the collet 236 with the head 238 for releasable fixation with the bone fastener 222. The sleeve 218 extends along a portion of the sleeve 216 and is configured to axially translate relative to the sleeve 216. When the knob 220 is rotated in the direction I shown in fig. 23A, the sleeve 216 is axially translated in the direction B shown in fig. 23A and 23B. By axially translating the sleeve 216 in direction B, the fingers 250a, 250B, 250c, and 250d move out of the sleeve 218. The fingers 250a, 250b, 250c, and 250d may translate over the head 238 of the fastener 222. In one or more instances, the key portions 242a and 242b of the collet 236 can be aligned with one or more screw flats 240a of the fastener 222. As shown in fig. 23B, when the knob 220 is rotated in direction F, the fingers 250a, 250B, 250c, and 250d move into the sleeve 218 and are driven further inward by the force of the sleeve 218 engaging the collet 236. By engaging the sleeve 218 with the collet 236, the fingers 250a, 250b, 250c, and 250d move about the head 238 from the open position to the closed position. Knob 220 may be rotated in direction F such that surface 295a of collet 236 and surface 295b of sleeve 218 are pressed against each other and sleeve 216 and/or 218 is axially rigid relative to drive shaft 202. The rotational force pulls the fastener 222 tight against the end 208 of the drive shaft 202. After engaging fingers 250a, 250b, 250c, and 250d to head 238 of fastener 222, collet 236 may be locked with head 238.

In one or more embodiments, surgical instrument 210 may be modular such that sleeve 216 and sleeve 218 with a depth stop or sleeve 216 and sleeve 304 without a depth stop may be connected to drive shaft 202. In one or more instances, the knob 214 attached to the drive shaft 202 includes a spring-loaded push button 302 disposed on a cylindrical surface of the knob 214. The knob 220 attached to the sleeve 218 includes a receiving portion 300 configured to receive a button 302 therein. The receiving portion 300 may be a through hole serving as a receptacle for receiving the button 302. The receiving portion 300 may be formed in a geometry to receive the button 302.

The sleeve 218 may be removed by pressing the button 302 out of the receiving portion 300 and sliding the sleeves 216 and 218 toward the end 208 of the drive shaft 202. The sleeves 216 and 218 may be attached to the drive shaft 202 by inserting the drive shaft 202 through the passage 232 and positioning the receiving portion 300 of the knob 220 over the button 302. As the end of the knob 220 translates over the button 302, the button 302 is depressed, compressing the spring of the button 302. After the receiving portion 300 is positioned over the button 302, the button 302 springs upward into the receiving portion 300, thereby rotatably locking the sleeves 216 and 218 to the drive shaft 202. It should be noted that knob 214 includes one button and knob 220 includes a corresponding receiving portion; however, embodiments are contemplated in which the knob 214 includes more than one button and the knob 220 includes more than one receiving portion.

In one or more instances, the sleeve 304 is an elongated tubular member having a substantially uniform shape. The sleeve 304 includes one or more of the same or similar features as the sleeve 218, except that there is no depth stop. Therefore, the description of such features is not repeated. It should be noted that fig. 20B and 20A illustrate the head 238 of the fastener 222 being inserted into the sleeve 218 containing the depth stop. Further, it should be noted that the head 238 of the fastener 222 may be inserted into the sleeve 304 in the same or similar manner as the head 238 is inserted into the sleeve 218, as described herein. Therefore, the description of such features is not repeated.

In one or more instances, as shown in fig. 26, the system 300 can be preassembled, i.e., not in situ at the surgical site.

As discussed herein, in assembly, operation, and use, a surgical implant system 200 similar to the systems and methods described herein is employed with a surgical procedure for treating a spinal disorder affecting a spinal column segment of a patient. For example, the system 200 may be used with a surgical procedure for treating a pathology or injury of an affected section of a spine that includes vertebrae. In some embodiments, one or all of the components of the system 200 may be delivered as a pre-assembled device, or may be assembled in situ. The system 200 may be modified, removed, or replaced, in whole or in part.

For example, the system 200 may be used in a surgical procedure to treat applicable pathologies or injuries of the spine and affected sections of adjacent regions (e.g., vertebrae) (not shown) within the body. In some embodiments, system 200 may be used for one or more vertebrae. To treat a selected section of a vertebra, a medical practitioner gains access to the surgical site containing the vertebra in any suitable manner (e.g., by incision and retraction of tissue). In some embodiments, the system 200 may be used with any existing surgical method or technique, including open surgery, mini open surgery, minimally invasive surgery including percutaneous surgical implantation, whereby a vertebra is accessed through a micro-incision or sleeve providing a protected channel to a region. Once access to the surgical site is obtained, specific surgical procedures may be performed to treat the spinal disorder.

An incision is cut in the patient and a cutting instrument (not shown) creates a surgical pathway for the implantable components of the delivery system 200. Preparation instruments (not shown) may be used to prepare the vertebrae and the tissue surfaces for aspiration and irrigation of the surgical field.

As shown in fig. 23A, surgical instrument 210 may be disposed in a first position such that collet 236 is in a biased closed position extending a distance from end 270 of sleeve 218. The mating surface 208a of the drive shaft 202 may engage the mating surface 254 of the fastener 222. Rotation of knob 220 in direction I shown in fig. 23A and 23B causes sleeve 216 to follow axis L in direction B shown in fig. 20B and 23B ₁And (4) translating. By translating sleeve 216 in direction B, collet 236 may capture head 238.

As sleeve 216 translates out of sleeve 218, fingers 250a, 250B, 250C, and 250d of collet 236 expand in direction C shown in fig. 23B to a biased closed position. As fingers 250a, 250b, 250C, and 250d translate to an open position over outer circumferential surface 278 of fastener 222, fingers 250a, 250b, 250C, and 250d may expand further in direction C. As fingers 250a, 250B, 250c, and 250D translate over surface 278, fingers 250a, 250B, 250c, and 250D are pushed back into a closed position in direction D as shown in fig. 23B due to the resilient bias of fingers 250a, 250B, 250c, and 250D. The fingers 250a, 250b, 250c, and 250d may snap fit around the head 238, thereby capturing the head 238 within the fingers 250a, 250b, 250c, and 250 d. Further rotation of knob 220 in direction I shown in fig. 23C causes sleeve 218 to translate in direction E shown in fig. 23C such that end 270 of sleeve 218 translates over collet 236 and compresses fingers 250a, 250b, 250C, and 250d of collet 236. By compressing fingers 250a, 250b, 250c, and 250d, fingers 250a, 250b, 250c, and 250d may be tightened about surface 278 of head 238 to releasably secure surgical instrument 210 with fastener 222 to engage drive shaft 202, which rotates with rotation of knob 214 and/or knob 220.

In one or more instances, drive shaft 202 may be rotated by rotating knob 214 and/or knob 220 in direction a shown in fig. 23C. In one or more instances, the drive shaft 202 can be rotated by rotating a handle attached to the end 204 of the drive shaft 202 and/or the drive shaft 202 itself in the direction a shown in fig. 23C. The handle, drive shaft 202, knob 214, and/or knob 220 may be rotated to apply a torsional force to fastener 222 and increase the depth of the guide hole and/or fasten fastener 222 with tissue. As the pilot hole depth increases, shaft 252 engages the cortical bone outer layer such that fastener 222 is about axis L₁Further rotation causes the shaft 252 to move through the guide hole and the outer layer of cortical bone and into the cancellous bone layer. In some embodiments, fastener 222 is rotated until the shaft of fastener 222 penetrates the vertebra to secure fastener 222 to the tissue. In one or more embodiments, as discussed herein, the translational stops 288 and/or depth stops of the surgical instrument 210 can prevent the fasteners 222 from penetrating beyond selected limits into the vertebrae. Rotation of the handle, drive shaft 202, knob 214, and/or knob 220 in the J direction causes the drive shaft 202 to loosen the fastener 222 from the vertebral body.

The components of system 200 including surgical instrument 210 and fastener 222 are used to augment one or more surgical treatments. As described herein, surgical instrument 210 can be disposed in a first, non-locking orientation to release fastener 222 from collet 236. To disengage surgical instrument 210 from fastener 222, knob 220 is rotated in the opposite direction F shown in fig. 23C to translate sleeve 218 in direction G shown in fig. 23C. Translating sleeve 218 in direction G may release the compressive force around collet 236. Further rotation of the knob 220 in the direction F shown in fig. 23B and 23C causes the sleeve 216 to translate in the direction H shown in fig. 20B and 23B. As the sleeve 216 translates in the direction H, the fingers 250a, 250b, 250c, and 250d move away from the head 238 and disengage the fingers 250a, 250b, 250c, and 250d from the head 238. The mating surface 208a of the drive shaft 202 may be disengaged from the mating surface 254 of the fastener 222. It should be noted that rotation in direction I and direction a causes one or more components to move in directions B and/or E, and rotation in direction J and direction a causes one or more components to move in directions G and/or H. However, it should be understood that in one or more other instances, rotation directions I and a cause one or more components to move in directions G and/or H, and rotation directions J and a cause one or more components to move in directions B and/or E.

Surgical instrument 210 may be reassembled for surgical procedures. In some embodiments, the system 200 may include various instruments, including the locking and collet configurations of the present disclosure, for example, inserters, dilators, microsclers, dilators, blades, distractors, clamps, forceps, lifters (elevators), and drill bits, which may alternatively be sized and dimensioned, and arranged in a kit.

After the procedure is completed, surgical instrument 210, surgical instruments, and/or tools, assemblies, and non-implanted components of system 200 are removed and one or more incisions are closed. One or more of the components of the system 200 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 system 200, the use of surgical navigation, microsurgery, and image guidance techniques may be used to access, view, and repair spinal degeneration or injury. In some embodiments, the system 200 may include one or more plates, connectors, and/or bone fasteners for use with a single vertebral level or multiple vertebral levels.

In one or more embodiments, as shown in fig. 24A-24G, surgical instrument 210 may use another modular configuration to attach sleeve 428 to sleeve 416. It should be noted that the sleeve 416 includes one or more of the same or similar features as the sleeve 216. Accordingly, the description of such features is not repeated, and the following description discusses features of the sleeve 416 that differ from features of the sleeve 216. It should be noted that the sleeve 428 includes one or more of the same or similar features as the sleeve 218. Accordingly, the description of such features is not repeated, and the following description discusses features of the sleeve 428 that differ from features of the sleeve 218. It should be noted that knob 414 includes one or more of the same or similar features as knob 214. Accordingly, the description of such features is not repeated, and the following description discusses features of the knob 414 that differ from features of the knob 214. Further, it should be noted that knob 426 includes one or more of the same or similar features as knob 220. Accordingly, the description of such features is not repeated, and the following description discusses features of the knob 426 that are different from the features of the knob 220.

In one or more instances, the surgical instrument 210 may include a key 402 and a cutout 404 to prevent the drive shaft 202 and the sleeve 416 from axially rotating about each other. In one or more instances, the sleeve 416 may include a cutout 404 extending across a portion of the threaded portion 234. In one or more other instances, the cutout 404 may extend across the threaded portion 234 and to the unthreaded portion 416a of the sleeve 416. The cutout 404 may be a receptacle configured to receive the key 402 disposed on the outer surface of the drive shaft 202. The key 402 may be in the direction L₁An elongate protrusion extending upwardly and protruding from the outer surface of the drive shaft 202. The key 402 may be configured to interlock with the notch 404. For the case where the key 402 and the cutout 404 are interlocked, the drive shaft 202 and the sleeve 416 may translate through the sleeve 428, but are prevented from axially rotating about each other. That is, the drive shaft 202 is prevented from rotating axially in a direction other than the axial rotation of the sleeve 416, and vice versa. In one or more other instances, the drive shaft 202 can include the cutout 404, and the sleeve 416 can include the key 402. In one or more instances, the knob 426 may include a cavity 424 in which the spring 422 is housed. On the inner surface of cavity 424, one or more pins (e.g., pins 410a, 410b, and 410c) may protrude from the inner surface of cavity 424 toward the center of cavity 424. It should be noted that in one or more instances, the sleeve 216 includes a cutout, similar to the cutout 404, that is configured to interlock with the key 402 disposed on the drive shaft 202.

In one or more instances, the knob 414 can include an interlocking portion 412 that includes one or more tracks (e.g., tracks 406a, 406b, and 406c) and one or more interlocking notches (e.g., interlocking notches 408a, 408b, and 408 c). The interlocking portion 412 may be a cylindrical rigid ring disposed on the proximal end of the knob 414. In one or more instances, each track can be recessed within the interlocking portion 412 of the knob 414. The tracks 406a, 406b, and 406c may be circumferentially disposed about the interlock portion 412. The tracks 406a, 406b, and 406c may each extend laterally across the width of the interlocking portion 412. In one or more instances, the tracks 406a, 406b, and 406c can each be sized to receive a width of a pin (e.g., pins 410a, 410b, and 410c) therein. In one or more instances, the interlock recesses 408a, 408b, and 408c can be circumferentially disposed about the interlock portion 412. As shown in fig. 24B, an interlock recess, such as interlock recess 408a, can be positioned between two rails, such as rails 406a and 406B. Each interlock recess may be recessed inwardly from the inner surface 418a of the interlock portion 412. Interlocking notches 408a, 408b, and 408c may each be sized to receive at least a portion of a pin (e.g., pins 410a, 410b, and 410c) therein.

In one or more instances, the knob 426 and sleeves 428 and 416 may be pre-assembled with one another, forming a modular sleeve that can be removed and attached to the drive sleeve 202. To assemble the sleeves 428 and 416 to the drive shaft 202, the drive shaft 202 is translated through the passage 232 of the sleeve 416. The knob 426 is rotated such that the pins of the knob 426 align with the tracks of the interlocking portion 412. For example, knob 426 and/or knob 414 may be rotated such that pins 410a, 410b, and 410c are aligned with tracks 406a, 406b, and 406c and key 402 is aligned with cutout 404. After aligning the one or more pins with the one or more tracks and/or aligning the keys 402 with the cutouts 404, the knob 426 is moved in the direction K shown in fig. 24D, and the one or more pins may be moved through their respective tracks and may be positioned over the rotating portion 420 of the knob 414. The key 402 may be inserted into the cutout 404.

By moving the knob 426 in the direction K, the outer surface 418b of the interlock portion 412 contacts the outer surface of the spring 422 and compresses the spring 422 in the direction 422b shown in fig. 24A. After positioning the one or more pins over the rotating portion 420, the knob 426 and/or the knob 414 is rotated in the direction L shown in fig. 24E to align the one or more pins with the one or more interlocking notches. For example, pin 410a may be aligned with interlock portion 408a, pin 410b may be aligned with interlock portion 408b, and pin 410c may be aligned with interlock portion 408 c. After aligning the one or more pins with the one or more interlocking notches, the knob 426 may be moved in the direction M shown in fig. 24F. At least a portion of the one or more pins may enter and interlock with the one or more interlocking portions, respectively. For example, at least a portion of the pin 410a may be positioned within the interlocking portion 408 a.

In one or more instances, the spring 422 can decompress and exert a force in the direction 422a shown in fig. 24A, thereby biasing the one or more pins into the corresponding one or more interlocking portions. In the interlocked position, a space 430 may be formed that indicates that one or more pins are inserted into the corresponding one or more interlocking portions. In one or more instances, the knob 426 can include one or more ergonomic grooves, such as a groove 426a disposed circumferentially around the knob 426. One or more recesses 426a may be used to facilitate rotation of the knob 426 about the drive shaft 202. In one or more instances, the knob 414 can include one or more ergonomic grooves, such as a groove 414a disposed circumferentially around the knob 414. One or more recesses 414a may be used to facilitate rotation of the knob 414. In one or more instances, the one or more recesses 426a of the knob 426 and the one or more recesses 414a of the knob 414 can provide visual feedback indicating that the one or more pins are aligned with the one or more interlock recesses. For example, when the one or more grooves 426a and the one or more grooves 414a are aligned with each other and form one or more continuous grooves extending from the knob 426 to the knob 414, the one or more pins are aligned with the one or more interlocking notches.

In one or more embodiments, various modular sleeves may be removably coupled to the drive shaft 202 by a modular configuration as shown in fig. 24A-24G. For example, the modular sleeve may include a sleeve 428 that is a keyed depth stop sleeve similar to keyed depth stop sleeve 218. In anotherIn an example, the modular sleeve may contain sleeve 430, which is a keyed drive sleeve similar to keyed drive sleeve 304. In other examples, the modular sleeve may contain a modular drive sleeve 434 without a key portion; a modular drive sleeve 432 with a depth stop and no key portion; assembled modular sleeve 436; reducing the assembled modular sleeve 438; and Voyager^TMThe assembled sleeve 440.

As used herein, the term "about" with respect to a numerical value means plus or minus 10% of the numerical value of the number being used.

It will be understood that various modifications may be made to the embodiments disclosed herein. Accordingly, the foregoing 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.