Surgical instruments and methods
By designing a surgical instrument system suitable for bone screws without tulip-shaped heads, the problems of implant inventory management and fixation in the prior art are solved, enabling flexible modular implant selection and stable spinal fixation, suitable for the treatment of a variety of spinal conditions.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- WARSAW ORTHOPEDIC INC
- Filing Date
- 2020-09-03
- Publication Date
- 2026-05-26
AI Technical Summary
In current spinal surgery, the lack of flexibility in implant inventory management and implant selection in the operating room makes it difficult to achieve modular implant selection with minimal inventory, and existing instruments are not effective in fixing bone screws that do not have traditional tulip-shaped heads.
A surgical instrument system is provided, comprising an actuator and a sleeve structure, capable of engaging with bone screw shanks without tulip-shaped heads. The system achieves secure fixation of the bone screw through a flexible chuck and sleeve design, and prevents excessive implantation by drilling a path through the reamer end surface. It also supports the use of various types of receivers.
It enables modular implant selection with minimal inventory in the operating room, effectively fixes bone screws without tulip-shaped heads, improves implant flexibility and stability, and is suitable for the treatment of various spinal conditions.
Smart Images

Figure CN114340526B_ABST
Abstract
Description
[0001] Cross-reference to related applications
[0002] This application is a continuation-in-part claim to the benefit of U.S. non-provisional patent application serial number 14 / 645,232 entitled “Surgical Instruments and Methods”, filed March 11, 2015, which is incorporated herein by reference in its entirety. Technical Field
[0003] This disclosure generally relates to medical devices for treating musculoskeletal disorders, and more specifically to surgical systems and methods for treating the spine. Background Technology
[0004] Spinal disorders such as degenerative disc disease, herniated disc, osteoporosis, vertebral lordosis, spinal stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders typically lead to symptoms including pain, nerve damage, and partial or complete loss of mobility.
[0005] Non-surgical treatments, such as medication, rehabilitation, and exercise, may be effective, but may not relieve the symptoms associated with these conditions. Surgical treatments for these spinal conditions include orthopedics, fusion, fixation, discectomy, laminectomy, and implant-supported prostheses. As part of these surgical treatments, spinal structures comprising implants such as bone fasteners, connectors, plates, and vertebral rods are often used to provide stability to the treated area. These implants can redirect stress away from the damaged or defective area as healing occurs, restoring proper alignment and generally supporting the vertebral components. Surgical instruments, for example, are used to engage fasteners to attach to the exterior of two or more vertebral components. This disclosure describes improvements to these prior art. Summary of the Invention
[0006] In one embodiment, a surgical instrument is provided. The surgical instrument includes a first component that engages with a first end of a fastener, the second end of which is configured to penetrate tissue. A second component includes an expandable component configured to engage the first end. In some embodiments, systems and methods are disclosed. Attached Figure Description
[0007] This disclosure will become clearer from the specific description accompanying the following figures, in which:
[0008] Figure 1 This is a perspective view of the components of a surgical system based on the principles of this disclosure;
[0009] Figure 2 yes Figure 1 A perspective view of the components shown;
[0010] Figure 3 yes Figure 1 A perspective view of the components shown;
[0011] Figure 4 yes Figure 1 A perspective view of the components shown;
[0012] Figure 4A yes Figure 1 The components shown are shown in a separate view;
[0013] Figure 5 yes Figure 1 A cross-sectional view of the components shown;
[0014] Figure 6 yes Figure 1 The components shown are shown in a separate view;
[0015] Figure 7 yes Figure 1 The components shown are shown in a separate view;
[0016] Figure 8 yes Figure 1 The components shown are shown in a separate view;
[0017] Figure 9 yes Figure 1 The components shown are shown in a separate view;
[0018] Figure 10 This is a perspective view of the components of a surgical system based on the principles of this disclosure;
[0019] Figure 11 yes Figure 10 A perspective view of the components shown;
[0020] Figure 12 yes Figure 10 The components shown are shown in a separate view;
[0021] Figure 13 yes Figure 10 The components shown are shown in a separate view;
[0022] Figure 14 yes Figure 10 The components shown are shown in a separate view;
[0023] Figure 15 yes Figure 10End view of the components of the surgical system shown;
[0024] Figure 16 This is a perspective view of the components of a surgical system based on the principles of this disclosure;
[0025] Figure 17 yes Figure 16 The detached view of the components shown in the image;
[0026] Figure 18A yes Figure 16 A perspective view of the components of the surgical system shown; Figure 18B yes Figure 16 Cross-sectional view of the components of the surgical system shown;
[0027] Figure 19 yes Figure 16 A cross-sectional view of the components shown;
[0028] Figure 20A yes Figure 16 A cross-sectional view of the components shown;
[0029] Figure 20B and 20C yes Figure 16 A perspective view of the components shown;
[0030] Figure 20D-20G yes Figure 16 A perspective view of the components shown; and
[0031] Figures 21A-21C yes Figure 16 A perspective view of the components of the surgical system shown. Detailed Implementation
[0032] Exemplary embodiments of surgical systems are discussed from the perspective of medical devices for treating musculoskeletal disorders, and more specifically from the perspective of surgical systems and methods for treating the spine. In some embodiments, the system includes surgical instruments and associated methods of use, which can be used with a spinal construct comprising bone fasteners and connectors having pop-out, snap-fit, click, and / or sliding members that provide a universal connection system to a spinal surgeon. In some embodiments, the spinal construct allows the use of a single bone screw assembly with multiple types of receivers, thereby minimizing inventory while producing patient-specific customized assemblies.
[0033] In some embodiments, the system includes surgical instruments and associated methods of use that can be used with bone screw shanks not pre-attached to tulip-shaped heads. In some embodiments, such bone screws without pre-attached tulip-shaped heads allow for modular implant selection in the operating room with minimal inventory and enable in-situ attachment of spinal rod receivers.
[0034] 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-shaped 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-shaped head or other type of spinal rod receiver component. 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 engage around the spherical head of the bone screw by pushing down an outer sleeve configured to force the inner sleeve downward. In one embodiment, the system includes a driver having an inner sleeve and an outer sleeve coupled together via a threaded interface and configured for relative translation from a first open position to a second closed position.
[0035] In one embodiment, the system includes an actuator having an outer sleeve configured to prevent the flexible clamp from expanding in the closed position, and the system allows disengagement from the bone screw in the open position. In another embodiment, the system includes an actuator having an outer sleeve configured to...
[0036] As the outer sleeve translates, it applies a force to the retaining cap of the drive shaft. In one embodiment, the system includes a driver having an outer sleeve configured to translate to apply a compressive force between the bone screw and the collet to secure the screw to the driver, thereby reducing the toggle between the bone screw and the drive shaft.
[0037] In one embodiment, the system includes an actuator with a tip that mimics the shape of a tulip-shaped head and provides a rigid stop to prevent the bone screw from being driven too deep. In another embodiment, the system includes an actuator with a tip that is a reamer configured to drill a passage to allow the tulip-shaped head to be engaged without interference from the patient's anatomy.
[0038] In one embodiment, the system includes a surgical instrument, such as an actuator. In some embodiments, the actuator has an outer sleeve having an outer tube. In some embodiments, the outer sleeve has a handle configured to rotate relative to the outer tube. In some embodiments, the actuator has an inner sleeve and a drive shaft with an oriented pin. In some embodiments, the actuator has a retainer cap. In one embodiment, the system includes an actuator with a threaded handle configured to translate the outer sleeve and apply compressive force between the bone screw and the inner sleeve. In one embodiment, the system includes an actuator with a reamer tip. In one embodiment, the system includes an actuator with a chuck on the inner sleeve configured to engage with the ball of the bone screw.
[0039] In one embodiment, the system includes an actuator having a tip configured to mimic a tulip-shaped head and prevent the bone screw from being driven too deep into the patient's anatomy to allow for tulip-shaped head attachment. In one embodiment, the actuator has a chuck on an inner sleeve.
[0040] In one embodiment, the system includes an actuator that provides a secure and rigid connection between a bone screw or receiver assembly without a tulip-shaped head. In another embodiment, the system includes an actuator that facilitates the use of an implantation system in which the tulip-shaped head can be attached to a bone screw.
[0041] 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 internal shaft configured as an actuator. In one embodiment, the system includes an instrument having a combination of two sleeves disposed around the outside of an actuator. In one embodiment, the instrument includes an actuator configured to extend beyond the sleeves such that an end of the actuator extends beyond the end of the sleeve to reach the fastener. In one embodiment, the system includes an instrument having a sleeve configured to translate over the top of the fastener and rotate along a 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 tissue too deeply to allow an implant to attach to the head of the fastener. In one embodiment, the system includes an instrument having an end of a sleeve configured to replicate the geometry of a fastener receiver to facilitate attachment of the fastener receiver to the fastener head. In one embodiment, the system includes an instrument having a diameter at the end of an outer sleeve that resembles the diameter of a tulip-shaped receiver, similar to that of a fastener.
[0042] In some embodiments, the systems disclosed herein can be used to treat spinal conditions such as degenerative disc disease, herniated disc, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the systems disclosed herein can be used in conjunction with other bone and bone-related applications, including those related to diagnosis and treatment. In some embodiments, the disclosed systems can be alternatively used for surgical treatment of patients in prone or supine positions, and / or for various surgical approaches to the spine, including anterior, posterior, posterior midline, direct lateral, posterolateral, and / or anterolateral approaches, as well as in other body regions. The systems disclosed herein can also be alternatively used in conjunction with surgeries for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The systems disclosed herein can also be used in animals, bone models, and other non-biological substrates, for example, during training, testing, and demonstration.
[0043] The systems of this disclosure can be more readily understood through the following detailed description of embodiments taken in conjunction with the accompanying drawings, which form a part of this disclosure. It should be understood that this application is not limited to the specific apparatus, methods, conditions, or parameters described and / or shown herein, and 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, unless the context explicitly requires otherwise, the singular forms “a” and “the” as used in the specification and incorporating the appended claims include the plural, and reference to a particular numerical value includes at least said particular value. A range may be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. In expressing this range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation using the antecedent “about”, it should be understood that said particular value forms another embodiment. It should also be understood that all spatial references, such as horizontal, vertical, top, upper, lower, bottom, left, and right, are for illustrative purposes only and may vary within the scope of this disclosure. For example, the terms “upper” and “lower” are relative and are used only in context for the other, and are not necessarily “superior” and “subordinate”.
[0044] Furthermore, as used in the specification and including the appended claims, “treating” a disease or condition means performing surgery, which may involve administering one or more drugs to a patient (human, normal, or abnormal, or other mammal), employing an implantable device, and / or using instruments for treating the disease, such as miniature discectomy instruments for removing protruding portions or herniated discs and / or osteophytes, in an effort to alleviate the signs or symptoms of the disease or condition. Relief may occur before or after the onset of the signs or symptoms of the disease or condition. Therefore, treatment includes preventing the disease or adverse condition (e.g., preventing the disease from occurring in patients who may be susceptible to it but have not yet been diagnosed with it). Furthermore, treatment does not require complete relief of the signs or symptoms, does not require a cure, and particularly includes surgery with only marginal effects on the patient. Treatment may include suppressing the disease, such as inhibiting its progression, or alleviating the disease, such as causing disease regression. For example, treatment may include reducing acute or chronic inflammation; relieving pain and reducing and inducing the regeneration of new ligaments, bone, and other tissues; serving as an adjunct to surgical procedures; and / or any reconstructive surgery. Furthermore, as used in the specification and incorporating the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone, unless otherwise specifically stated.
[0045] The following discussion includes a description of a surgical system comprising surgical instruments, related components, and a method of employing the surgical system according to the principles of this disclosure. Alternative embodiments are also disclosed. See the exemplary embodiments of this disclosure illustrated in the accompanying drawings for details. [Turn to...] Figure 1-9 The present invention demonstrates the components of a surgical implant system 10 based on the principles of this disclosure.
[0046] The components of System 10 may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone materials, and / or composites thereof. For example, individually or collectively, the components of System 10 may be made of materials such as stainless steel alloys, aluminum, industrially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (e.g., nickel-titanium), and superelastic plastic metals such as GUM manufactured by Toyota Materials Corporation of Japan. Ceramics and their composites, such as calcium phosphate (e.g., SKELITE™ manufactured by Biologic Inc.), thermoplastics, such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicone resins, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers, including polyphenylene oxide, polyamides, polyimides, polyetherimides, polyethylene, epoxy resins, bone Materials include autologous, allogeneic, xenograft, or transgenic cortex and / or cortical cancellous bone, as well as tissue growth or differentiation factors, partially resorbable materials such as metal and calcium-based ceramic composites, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers, and fully resorbable materials such as calcium-based ceramics like calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyketide, polyglycolic acid, polytyrosine carbonate, polycaprolactone, and combinations thereof. Various components of system 10 may be made of composite materials containing the aforementioned materials to achieve various desired properties such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preference. Individually or collectively, components of system 10 may also be made of heterogeneous materials, such as combinations of two or more of the aforementioned materials. As described herein, the components of system 10 may be integrally formed, integrally connected, or contain fastening elements and / or instruments.
[0047] The system 10, which includes surgical instruments 12, is used, for example, in open or minimally invasive surgery, minimally invasive surgery, and / or minimally invasive surgery incorporating percutaneous surgical techniques to deliver and secure implants at a surgical site (e.g., a segment of the spine) within a patient. In one embodiment, components of the system 10 are configured to secure bone fasteners to tissue for surgical treatment of various spinal pathologies, such as those described herein.
[0048] like Figure 4-5 As shown, system 10 includes a surgical instrument 12, which includes components, such as a drive shaft 14 extending along axis L between end 18 and opposite end 20. End 18 includes a mating surface 22 configured to facilitate operation and / or manipulation of the surgical instrument 12. Surface 22 is configured to engage with a retaining cap 24. In one embodiment, drive shaft 14 includes a surface 26 defining a cavity 28 configured to receive toward pin 29.
[0049] like Figure 5 As shown, end portion 20 is configured to engage with an implant (e.g., bone fastener 82). In some embodiments, end portion 20 may have different cross-sections, such as square, hexagonal, polygonal, triangular, star-shaped, or hexalobe-shaped. End portion 20 may have various surface configurations, such as smooth, rough, arcuate, wavy, porous, semi-porous, recessed, polished, and / or textured.
[0050] A component, such as sleeve 30, is configured to house drive shaft 14. Sleeve 30 extends along axis L between end 32 and end 34. Sleeve 30 includes an inner surface 36 and an outer surface 38. Surface 36 defines a channel 40 coaxial with axis L and configured to house drive shaft 14. As described herein, surface 38 includes a threaded portion 39 configured to engage with a third component. End 34 includes an extendable component, such as a collet 42.
[0051] As described herein, the chuck 42 extends from the end 34 and is configured to move between a first configuration and a second configuration. Figure 6-9 As shown, the chuck 42 includes an inner surface 44 defining a channel 46. The channel 46 is coaxial with the channel 40. The channel 46 has a cylindrical cross-sectional configuration. In some embodiments, the channel 46 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and / or conical.
[0052] The chuck 42 includes a locking surface 48 defined by a plurality of radially outwardly extending cantilevered fingers 50. The fingers 50 are circumferentially arranged and equidistantly spaced. The fingers 50 are spaced apart by gaps 52 defined by opposing planar sidewalls 54. As described herein, in one embodiment, the chuck 42 is flexible, such that the chuck 42 is biased into a first closed position. The chuck 42 is configured to snap into a first end around, for example, the head 84 of a fastener 82. As the chuck 42 translates over the head 84 of the fastener 82, the chuck 42 moves from the first closed position to a second open position and returns to the first closed position to capture the head 84.
[0053] System 10 includes a third component, such as a sleeve 60. Sleeve 60 extends along axis L between end 62 and end 64. Sleeve 60 includes an inner surface 66 and an outer surface 68. Surface 66 defines a channel 70 coaxial with axis L and configured to movably accommodate sleeve 30. In one embodiment, inner surface 66 may have various surface configurations to enhance engagement of sleeve 30 and / or chuck 42, such as roughened, arcuate, wavy, porous, semi-porous, recessed, polished, and / or textured.
[0054] As described herein, end portion 62 includes a handle 72 having a threaded inner surface 74 configured to rotatably engage a threaded portion 39 to cause axial translation of sleeve 60 relative to sleeve 30, resulting in releasable locking of chuck 42 to bone fastener 82. End portion 64 includes a tip 76 defining a reamer end surface 78. Reamer end surface 78 includes a plurality of teeth 80 configured to drill a passage around head 84. In one or more cases, the teeth 80 are angled to cut in the direction of rotation of reamer end surface 78. In one or more other cases, the teeth 80 may be bidirectionally angled, allowing the teeth 80 to drill into tissue located around head 85 in a clockwise and / or counterclockwise direction. In one or more cases, the teeth 80 are configured to rotate independently of sleeve 60, such that the teeth rotate independently of elongated shaft 86.
[0055] As discussed herein, sleeve 60 is configured to lock clamp 42 to head 84 for releasable fixation to bone fastener 82. Sleeve 60 extends along a portion of sleeve 30 and is configured to translate axially relative to sleeve 30. When sleeve 60 is in Figure 9 When the finger 50 is axially translated in the direction indicated by arrow E, the force of the sleeve 60 engaging the chuck 42 further drives the finger 50 inward, allowing the finger 50 to move to a locked position around the head 84 with locking surface 48.
[0056] System 10 includes a fastener, such as a bone fastener 82. Fastener 82 includes a head 84 configured to engage with a drive shaft 14 and an elongated shaft 86 configured to penetrate tissue. The head 84 includes a spherical configuration. The head 84 includes an outer circumferential surface 88 having a substantially uniform diameter. In some embodiments, all or only a portion of surface 88 includes a spherical configuration. The head 84 includes an inner surface 90 defining a cavity, such as a mating surface 92. As discussed herein, the mating surface 92 is configured to accommodate an instrument and / or tool extension, such as the end 20 of the drive shaft 14. The mating surface 92 is centrally located relative to the head 84. The mating surface 92 is coaxial with axis L. In some embodiments, the mating surface 92 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and / or conical. In some embodiments, the inner surface 90 may have various surface configurations, such as smooth and / or surface configurations, to enhance engagement with the mating surface of the drive shaft 14, such as rough, arcuate, wavy, porous, semi-porous, recessed, polished and / or textured.
[0057] The shaft 86 has a cylindrical cross-sectional configuration and includes an outer surface with an external thread. In some embodiments, the thread may comprise a single-turn thread or a multi-turn discrete thread. In some embodiments, other engagement structures may be disposed on the shaft 86, such as stud configurations, barbs, extension elements, protrusions, and / or long studs, to facilitate engagement of the shaft 86 with tissues, such as vertebrae.
[0058] In some embodiments, all or only a portion of the shaft 86 may have alternative cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, interlaced, wavy, arcuate, deformable, and / or conical. 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 with tissue, such as rough, arcuate, wavy, mesh-like, porous, semi-porous, recessed, and / or textured. In some embodiments, all or only a portion of the shaft 86 may be positioned in alternative orientations relative to the longitudinal axis of the bone fastener 82, such as transverse, vertical, and / or other angular orientations, such as acute or obtuse angles, coaxial, and / or offset or interlaced. In some embodiments, all or only a portion of the shaft 86 may be cylindrical.
[0059] As discussed herein, in assembly, operation, and use, the surgical implant system 10, similar to the systems and methods described herein, is employed in conjunction with surgery for treating spinal conditions affecting a segment of the spine in a patient. For example, system 10 may be used in conjunction with surgery for treating a symptom or injury to an affected segment of the spine containing vertebrae. In some embodiments, one or all of the components of system 10 may be delivered as a pre-assembled device or may be assembled in situ. System 10 may be modified, removed, or replaced wholly or partially.
[0060] For example, system 10 can be used for surgical treatment of applicable conditions or injuries in affected segments of the spine and adjacent areas within the body (e.g., vertebrae) (not shown). In some embodiments, system 10 can be used on one or more vertebrae. To treat selected segments of the vertebrae, a medical practitioner obtains access to the surgical site containing the vertebrae in any appropriate manner (e.g., through incisions and tissue retraction). In some embodiments, system 10 can be used with any existing surgical method or technique, including open surgery, micro-open surgery, minimally invasive surgery involving percutaneous surgical implantation, thereby gaining access to the vertebrae through a micro-incision or a sleeve providing a protected passage to the area. Once access to the surgical site is obtained, specific surgical procedures can be performed to treat spinal conditions.
[0061] An incision is made inside the patient, and a cutting instrument (not shown) creates a surgical pathway for delivering the implantable component of system 10. A preparation instrument (not shown) can be used to prepare the vertebrae and the tissue surface for aspiration and irrigation of the surgical area.
[0062] The surgical instrument 12 can be positioned in a first position, such that the chuck 42 is in an offset closed position extending a distance from the end 64 of the sleeve 60. The end 20 of the drive shaft 14 engages with the mating surface 92. The handle 72 is in... Figure 5 The rotation in the direction indicated by arrow A causes the sleeve 30 to rotate in... Figure 8 The finger 50 translates along axis L in the direction indicated by arrow B, causing the chuck 42 to capture the head 84. As the finger 50 translates above surface 88, the finger 50 of the chuck 42... Figure 8 The finger 50 extends to the second position in the direction indicated by arrow C. As the finger 50 translates above the surface 88, the finger 50 is propelled by the elastic bias of the finger 50 through... Figure 8 The handle 72 moves in the direction indicated by arrow D and is pushed to the first position, engaging around the head 84, thereby capturing the head 84 within the finger 50. Locking surface 48 contacts surface 88. Further rotation of the handle 72 causes the sleeve 60 to... Figure 9The end 76 of the sleeve 60 is translated in the direction indicated by arrow E, so that it translates above the chuck 42 and compresses the fingers 50 of the chuck 42, and tightens the fingers 50 around the surface 88 of the head 84 to releasably secure the surgical instrument 12 to the fastener 82.
[0063] Translation of the sleeve 60 causes the teeth 80 of the reamer end surface 78 to drill into the tissue surrounding the head 85. In some embodiments, the reamer end surface 78 creates a circumferential pathway around the head 84, thereby providing space for an implant, such as a spinal rod receiver connected to the head 84.
[0064] The drive shaft 14 is rotated to apply a torsional force to the bone screw 82 and to increase the depth of the guide hole and / or to tighten the bone screw 82 to the tissue. As the overall depth of the guide hole increases, the shaft 86 engages the cortical outer layer of bone, causing the bone screw 82 to rotate further about the axis L, which results in the shaft 86 moving through the guide hole and the cortical outer layer of bone and into the cancellous bone layer. In some embodiments, the bone screw 82 is rotated until the shaft of the bone screw 82 penetrates the vertebra to fix the bone screw 82 to the tissue.
[0065] The components of system 10, including surgical instrument 12 and bone screw 82, are used to augment one or more surgical treatments. As described herein, surgical instrument 12 is positioned in a first non-locking orientation to release bone screw 182 from clamp 60. To disengage instrument 12 from fastener 82, handle 72 is... Figure 5 Rotation in the opposite direction indicated by arrow F causes the sleeve 60 to translate in the direction indicated by arrow G, thereby releasing the compressive force around the chuck 42. Rotation of the handle 72 causes the sleeve 30 to... Figure 8 The drive shaft 14 is disengaged from the head 84 by translating in the direction indicated by arrow H. This disengages the finger 50 from the head 84. The end 20 of the drive shaft 14 is then disengaged from the mating surface 92.
[0066] Surgical instruments 12 can be reassembled for use in surgical procedures. In some embodiments, system 10 may include a variety of instruments, including locking and clamping configurations of the present disclosure, such as inserters, expanders, miniaturizers, dilators, tensioners, blades, traction devices, clamps, forceps, elevators, and drills, which may alternatively be sized and dimensional and arranged in a kit.
[0067] After the procedure, surgical instruments 12, surgical instruments and / or tools, assemblies, and non-implantable components of system 10 are removed, and one or more incisions are closed. One or more components of system 10 may be made of a radiation-permeable material, such as a polymer. Radiolabels may be included for identification under X-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, system 10 can be used to access, view, and repair spinal degeneration or injury by means of surgical navigation, microsurgery, and image-guided techniques. In some embodiments, system 10 may include one or more plates, connectors, and / or bone fasteners for use with a single vertebra or multiple vertebral segments.
[0068] In one embodiment, such as Figure 10-15 As shown, similar to the systems and methods described herein, the spinal implant system 10 includes the device 12 described herein, the device 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 axis L between end 18 and opposite end 20.
[0069] like Figure 10 As shown, end portion 20 is configured to engage with bone fastener 82. Sleeve 30 is configured to house drive shaft 14. Sleeve 30 extends along axis L. Sleeve 30 includes a channel 40 coaxial with axis L and configured to house drive shaft 14. As described herein, sleeve 30 includes a collet 42. As described herein, collet 42 is configured to move between a first configuration and a second configuration. Figure 12-13 As shown, the chuck 42 includes an inner surface 44 defining a channel 46. The channel 46 is coaxial with the channel 40.
[0070] Sleeve 160 extends along an axis between end 162 and end 164. Sleeve 160 includes an inner surface 166 and an outer surface 168. Surface 166 defines a channel 170 coaxial with axis L and configured to movably accommodate sleeve 30.
[0071] End portion 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 threaded portion 39 to cause sleeve 160 to translate axially relative to sleeve 30, resulting in releasable locking of chuck 42 with bone fastener 82. Figure 12 As shown, the dimensions of end 164 are set and / or configured to be similar to those of a tulip-shaped head receiver. End 164 includes a diameter similar to that of a tulip-shaped head receiver. End 164 defines a cavity configured to receive clamp 42 and head 84, such that end 164 is disposed around head 84 and clamp 42, such that space for connecting the receiver is provided around head 84.
[0072] As discussed herein, sleeve 160 is configured to lock clamp 42 to head 84 for releasable fixation to bone fastener 82. Sleeve 160 extends along a portion of sleeve 30 and is configured to translate axially relative to sleeve 30. When sleeve 60 is in Figure 14 When the finger 50 is axially translated in the direction indicated by arrow I, the force of the sleeve 160 engaging the chuck 42 drives the finger 50 inward, so that the finger 50 can move to a locked position around the head 84 with the locking surface 48.
[0073] End portion 164 includes a rigid stop portion 178 configured to prevent the fastener 82 from penetrating into tissue beyond a selected limit. The rigid stop portion 178 allows the receiver to connect to the head 84.
[0074] In one embodiment, such as Figure 16-21C As shown, the surgical implant system 200 includes one or more of the same or similar features as described herein with respect to system 10. Components of system 200 may be manufactured and / or formed using one or more of the materials described with respect to system 10. Therefore, a description of these materials will not be repeated.
[0075] The system 200, which includes surgical instruments 210, is used, for example, in open or minimally invasive surgery, minimally invasive surgery, and / or minimally invasive surgery incorporating percutaneous surgical techniques to deliver and secure implants at a surgical site within a patient's body (e.g., a segment of the patient's spine). In one embodiment, components of the system 200 are configured to secure bone fasteners, such as bone fastener 222, for surgical treatment of various spinal pathologies, such as those described herein.
[0076] System 200 includes fasteners, such as bone fastener 222, as... Figure 18A and 18BAs shown in the diagram. Fastener 222 includes a head 238 configured to engage with drive shaft 202 and an elongated shaft 252 configured to penetrate tissue. Head 238 includes a spherical configuration. Head 238 includes an outer circumferential surface 278 having a substantially uniform diameter. In some embodiments, all or only a portion of surface 278 includes a spherical configuration. Head 238 includes an inner surface 280 defining a cavity, such as mating surface 254. As discussed herein, mating surface 254 is configured to accommodate an instrument and / or tool extension, such as mating surface 208a on end 208 of drive shaft 202. Mating surface 254 is centrally located relative to head 238. Mating surface 254 is coaxial with axis L1. In some embodiments, mating surface 254 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and / or conical. 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, wavy, porous, semi-porous, recessed, polished and / or textured.
[0077] The shaft 252 of the fastener 222 has a cylindrical cross-sectional configuration and includes an outer surface with an external thread. In some embodiments, the thread may include a single-turn thread or a multi-turn discrete thread. In some embodiments, other engagement structures may be disposed on the shaft 252, such as nail configurations, barbs, extension elements, protrusions, and / or spikes, to facilitate engagement of the shaft 252 with tissues, such as vertebrae.
[0078] 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, interlaced, wavy, arcuate, deformable, and / or conical. 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 with tissue, such as rough, arcuate, wavy, mesh-like, porous, semi-porous, recessed, and / or textured. In some embodiments, all or only a portion of the shaft 252 may be positioned in alternative orientations relative to the longitudinal axis L1 of the bone fastener 222, such as transverse, vertical, and / or other angular orientations, such as acute or obtuse angles, coaxial, and / or offset or interlaced. In some embodiments, all or only a portion of the shaft 252 may be cylindrical.
[0079] In one or more embodiments, the outer circumferential surface 278 of the head 238 includes one or more screw planes, such as screw plane 240a and screw plane 240b. As discussed herein, screw plane 240a may be configured to match the geometry of key portions (such as key portions 242a and 242b) of the collet 236. In one or more cases, the keyed surface 286 of screw plane 240a may be recessed into the outer circumferential surface 278 of the head 238. In one or more other cases, the keyed surface 286 of screw plane 240a may protrude from the outer circumferential surface 278 of the head 238. The keyed surface 286 of screw plane 240a may have a planar shape. The keyed surface 286 of screw plane 240a may extend across the outer circumferential surface 278 of the head 238. It should be noted that screw plane 240b includes one or more features that are the same as or similar to those of screw plane 240a. Therefore, descriptions of such features of screw plane 240b are not repeated. It should also be noted that two screw planes are described; however, embodiments are contemplated in which the head 238 contains one screw plane and in which the head 238 contains more than two screw planes (e.g., four screw planes), and in which the collet 236 contains a corresponding number of key portions (e.g., four key portions).
[0080] like Figure 16-17 As shown, system 200 includes a surgical instrument 210, which includes components such as a drive shaft 202 extending along axis L1 between end 204 and opposite end 208. End 204 includes a mating surface 206 configured to facilitate operation and / or manipulation of the surgical instrument 210. Surface 206 is configured to engage a handle. The handle may have a receiving portion on its inner surface, wherein the surface of the receiving portion is configured to receive end 204 of the drive shaft 202.
[0081] The drive shaft 202 may be an elongated rigid member with a solid center. The drive shaft 202 may include a stop 296 disposed around the outer surface of the shaft 202. The stop 296 may be a rigid body having a bushing 296a positioned at one end of the stop 296 and projecting outward from the shaft 202. The stop 296 may have a cylindrical disk 296b positioned at the end of the stop 296 opposite to the bushing 296a.
[0082] Bushing 296a and cylindrical disk 296b may be positioned on shaft 202 at a predetermined distance from each other to prevent shaft 202 from translating beyond the predetermined distance via sleeves 216 and 218. For example, bushing 296a may contact the outer surface 298 of knob 214 and prevent drive shaft 202 from moving a predetermined distance toward end 270. In another example, cylindrical disk 296b may contact the inner surface of knob 214 and prevent drive shaft 202 from moving away from end 270 by a predetermined distance. In one or more cases, knob 214 may be rotatable about drive shaft 202 and may be translated above drive shaft 202 relative to the distance defined by bushing 296a and cylindrical disk 296b. In one or more cases, bushing 296a may be used to facilitate connection of surgical instrument 210 to navigation tracking device, such as NavLock available from Medtronic, Inc. TM Tracker. For example... Figure 20A As shown, the navigation tracking device can be connected to the recessed portion 296c of the bushing 296a.
[0083] like Figure 16 As shown, the mating surface 208a on the end portion 208 is configured to engage with an implant, such as a bone fastener 222. In some embodiments, the end portion 208 may be formed with different cross-sectional shapes, such as, but not limited to, square, hexagonal, polygonal, triangular, star-shaped, or preferably hexalfalcon-shaped. The mating surface 208a may have various surface configurations, such as smooth, rough, arcuate, wavy, porous, semi-porous, recessed, polished, and / or textured. The mating surface 208a may be formed in a shape that allows it to be inserted into the mating surface 254 of the fastener 222.
[0084] The drive shaft 202 can be inserted through a channel 232 of a component, such as a sleeve 216. The sleeve 216 can be configured to house the drive shaft 202. The sleeve 216 can be an elongated tubular component having a cylindrical center forming the channel 232. The sleeve 216 extends along axis L1 between ends 224 and 226. The sleeve 216 includes an inner surface 228 and an outer surface 230. Surface 228 defines a channel 232 coaxial with axis L1 and configured to house the drive shaft 202. Surface 230 includes a threaded portion 234 configured to engage with a third component, such as a sleeve 218 and preferably a knob 220 of sleeve 218. End 226 includes an expandable component, such as a collet 236.
[0085] As described herein, the chuck 236 extends from the end 226 and is configured to move between an open position and a closed position. Figures 18A-18BAs shown, the chuck 236 includes an inner surface 260 defining a channel 262. The channel 262 is coaxial with the channel 232. The channel 262 has a cylindrical cross-sectional configuration. In some embodiments, the channel 262 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, deformable, tubular, and / or conical.
[0086] The collet 236 can 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, it moves from a closed position to an open position and returns to a closed position to capture the head 238. The collet 236 can snap-fit around the head 238 of the fastener 222 via a plurality of cantilevered fingers 250a, 250b, 250c, and 250d. The plurality of cantilevered fingers 250a, 250b, 250c, and 250d can define an inner surface 260 of the collet 236 that serves as a locking surface. The fingers 250a, 250b, 250c, and 250d can extend radially outward from the end 226 of the sleeve 216. The fingers 250a, 250b, 250c, and 250d can be circumferentially arranged and equidistantly spaced. The 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 towards the distal ends of the fingers 250a, 250b, 250c, and 250d. The distal ends of the fingers 250a, 250b, 250c, and 250d may include a second surface 282 integrally connected to the first surface 284. The second surface may taper away from the distal ends of the fingers 250a, 250b, 250c, and 250d. It should be noted that the chuck 236 is described as having four fingers; however, embodiments in which the chuck 236 contains fewer than four fingers and embodiments in which the chuck 236 contains more than four fingers are contemplated.
[0087] In one embodiment, the chuck 236 is flexible, such that the 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. Figure 18A The clamp 236 is shown biased in the closed position. Figure 18BA collet 236 is shown fitted around the head 238 of the fastener 222 in the first closed position. In the closed position, fingers 250a, 250b, 250c, and 250d cantilever from the end 226 of the sleeve 216, such that fingers 250a, 250b, 250c, and 250d extend parallel to or substantially parallel to the inner surface 228 and / or outer surface 230 of the sleeve 216. In the open position, fingers 250a, 250b, 250c, and 250d can bend outward away from the center of the channel 232.
[0088] In one instance, the collet 236 can be biased into a closed position. In one or more cases, the user can insert the mating surface 208a of the drive shaft 202 into the mating surface 254 of the fastener 222. The user can 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, one or more of the first surfaces 284 of the fingers 250a, 250b, 250c, and 250d contact the outer circumferential surface 278 of the head 238, and... Figure 21B The chuck 236 bends outward in direction C away from the center of channel 232, thereby moving the chuck 236 to the open position. The tapered portion of the first surface 284 facilitates 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 surface 282 of one or more of the fingers 250a, 250b, 250c, and 250d. As the second surface 282 translates over the head 238, the fingers 250a, 250b, 250c, and 250d... Figure 21B The direction D shown bends inward toward the center of channel 232, thereby returning the chuck 236 to the closed position and engaging the fastener 222 to the device 210.
[0089] In one or more embodiments, one or more of the fingers 250a, 250b, 250c, and 250d include key portions, such as key portions 242a and 242b. Key portion 242a may be configured to match the geometry of the screw plane 240a of the fastener 222. The collet 236 may include a plurality of key portions equal in number to the screw planes of the fastener 222. Key portion 242a may include a surface extending across the inner surface 260 of the collet 236. In one or more cases, the surface of key portion 242a may protrude from the inner surface 260 of the collet 236 to form a notch. In cases where the keyed surface 286 of the screw plane 240a has a notch, the protruding surface of key portion 242a may be configured to engage the keyed surface 286 of the screw plane 240a. In one or more other cases, the surface of key portion 242a may be a surface recessed into the inner surface 260 of the collet 236 to form a cavity. In cases where the keyed surface 286 protrudes from the outer circumferential surface 278 of the head 238, the recessed surface of the key portion 242a can be configured to engage the keyed surface 286 of the screw plane 240a. The surface of the key portion 242a can have a different shape than the inner surface 260 of the collet 236, such as a planar shape. In one or more cases, the key portion 242a can be fully seated on one of the fingers 250a, 250b, 250c, and 250d. In one or more other cases, such as Figure 18A As shown, a portion of the key portion 242a may be disposed on a portion of a finger (such as finger 250b), and another portion of the key portion 242a may be disposed on a portion of an adjacent finger (such as 250c).
[0090] It should be noted that key portion 242b includes one or more features that are the same as or similar to those of key portion 242a. Therefore, a description of such features of key portion 242b will not be repeated. It should also be noted that two key portions have been described; however, embodiments in which the chuck 236 includes one key portion and embodiments in which the chuck 236 includes more than two key portions are contemplated.
[0091] like Figure 17 As shown, system 200 includes a third component, such as sleeve 218. Sleeve 218 extends along axis L1 between end 268 and end 270. Sleeve 218 includes an inner surface 274 and an outer surface 272. Inner surface 274 defines a channel 276 coaxial with axis L1 and configured to movably accommodate sleeve 216. In one embodiment, inner surface 274 may have various surface configurations to enhance engagement of sleeve 216 and / or chuck 236, such as roughened, arcuate, wavy, porous, semi-porous, recessed, polished, and / or textured.
[0092] like Figure 19As shown, the surgical instrument 210 may include a translation stop 288. The translation stop 288 may be configured to limit the axial translation of the sleeve 216 through the sleeve 218 by a distance, for example, a distance D1. Furthermore, the translation stop 288 may be configured to prevent the sleeve 216 from rotating axially within the sleeve 218. The translation stop 288 may include one or more rails (such as rails 248a and 248b) and one or more pins (such as pins 246a and 246b). In one or more cases, rails 248a and 248b may each be disposed on the sleeve 216, and pins 246a and 246b may each be disposed on the sleeve 218, as shown in the diagram. Figure 17 and 19 As shown in the figure. In one or more other cases, rails 248a and 248b may be mounted on sleeve 218, and pins 246a and 246b may be mounted on sleeve 216.
[0093] In the case where tracks 248a and 248b are mounted on sleeve 216, tracks 248a and 248b can be through holes extending from the outer surface 230 of sleeve 216 to the inner surface 228 of sleeve 216. Tracks 248a and 248b can be sized to accommodate pins 246a and 246b, respectively. In the case where pins 246a and 246b are mounted on sleeve 218, pins 246a and 246b can protrude into channel 276. Pins 246a and 246b can be mounted on sleeve 218 such that pins 246a and 246b can be positioned within tracks 248a and 248b, respectively. Pins 246a and 246b can protrude into channel 276 far enough to contact at least a portion of the stop surface 292a of track 248a and the stop surface 292b of track 248b. Pins 246a and 246b may protrude sufficiently into channel 276 to contact at least a portion of the stop surface 294a of track 248a and the stop surface 294b of track 248b. Pins 246a and 246b may protrude sufficiently into channel 276 to not interfere with the movement of drive shaft 202 within channel 232.
[0094] In one or more cases, pins 246a and 246b, and stop surfaces 292a and 292b, are configured to prevent sleeve 216 from moving beyond a predetermined distance D1. For example, when sleeve 216 translates through sleeve 218, sleeve 216 may move a distance D1 toward the distal end of surgical instrument 210. After moving a distance D1, stop surfaces 292a and 292b contact pins 246a and 246b, respectively, thereby limiting the axial translational distance of sleeve 216 through sleeve 218.
[0095] In one or more cases, the end 270 of the sleeve 218 can serve as a depth stop to prevent the fastener 222 from penetrating into the body (e.g., a vertebra of the spine) beyond a distance D2. In one or more cases, the distance D2 can range from equal to or about 3.5 mm to equal to or about 5 mm. More preferably, the distance D2 can be equal to or about 4 mm. The end 270 of the sleeve 280 can be configured to surround a proximal thread 295f around the fastener 222. In one or more cases, by surrounding a portion of the thread 295f, when the fastener 222 is fastened, for example, into the vertebra and the chuck 236 is retracted into the end 270, the outer surface 295d of the end 270 can contact the outer surface of the vertebra, thereby preventing the fastener 22 from penetrating further into the vertebra. That is, when the outer surface 295d of the end 270 of the sleeve 218 contacts the outer surface of the vertebra, the surgical instrument 210 is prevented from inserting the fastener 222 to a full insertion depth 295e into the vertebra. In one or more cases, 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 thread 295f that can be surrounded by the end 270 of the sleeve 218.
[0096] In one or more cases, 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 can be configured to rotatably engage a threaded portion 234 of the sleeve 216. By threading the threaded inner surface 258 to the threaded portion 234, the knob 220 and the sleeve 218 can be rotatably coupled to the sleeve 216.
[0097] In one or more cases, the surgical instrument 210 may include a key 203 and a notch 205 to prevent the drive shaft 202 and the sleeve 216 from rotating axially about each other. In one or more cases, the sleeve 216 may include a notch 205 extending across a portion of the threaded portion 234. In one or more other cases, the notch 205 may extend across the threaded portion 234 and extend into the unthreaded portion 216a of the sleeve 216. The notch 205 may be a container configured to receive a key 203 disposed on the outer surface of the drive shaft 202. The key 203 may be an elongated protrusion extending in the direction L1 and projecting from the outer surface of the drive shaft 202. The key 203 may be configured to interlock with the notch 205. In the case where the key 203 and the notch 205 are interlocked, the drive shaft 202 and the sleeve 216 may translate through the sleeve 218 but are prevented from rotating axially 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 216, and vice versa. In one or more other cases, the drive shaft 202 may include a notch 205, and the sleeve 216 may include a key 203. In one or more cases, the knob 220 may be included in a cavity 299 therein, which houses the spring 297. On the inner surface of the cavity 299, one or more pins (such as pins 213a, 213b, and 213c) may protrude from the inner surface of the cavity 299 toward the center of the cavity 299.
[0098] In one or more cases, the knob 214 may include an interlocking portion 215 comprising one or more rails (such as rails 209a, 209b, and 209c) and one or more interlocking recesses (such as interlocking recesses 211a, 211b, and 211c). The interlocking portion 215 may be a cylindrical rigid ring disposed on the proximal end of the knob 214. In one or more cases, each rail may be recessed within the interlocking portion 215 of the knob 214. Rails 209a, 209b, and 209c may be circumferentially disposed around the interlocking portion 215. Rails 209a, 209b, and 209c may each extend laterally across the width of the interlocking portion 215. In one or more cases, the size of each rail 209a, 209b, and 209c may be set to accommodate the width of a pin (such as pins 213a, 213b, and 213c). In one or more cases, the interlocking notches 211a, 211b, and 211c can be circumferentially arranged around the interlocking portion 215. For example... Figure 20B As shown, interlocking recesses (such as interlocking recess 211a) can be positioned between two tracks (such as tracks 209a and 209b). Each interlocking recess can be slotted inward from the inner surface 217a of the interlocking portion 215. The sizes of interlocking recesses 211a, 211b, and 211c can each be set to accommodate at least a portion of a pin (such as pins 213a, 213b, and 213c).
[0099] To assemble sleeves 218 and / or 216 to drive shaft 202, knob 220 is rotated such that the pin of knob 220 aligns with the track of interlocking portion 215. For example, knob 220 and / or knob 214 can be rotated such that pins 213a, 213b, and 213c align with tracks 209a, 209b, and 209c and key 203 aligns with cutout 205. After aligning one or more pins with one or more tracks and / or aligning key 203 with cutout 205, knob 220 is... Figure 20D As shown, the knob 214 moves in the direction K, and one or more pins can move across their respective tracks and be positioned above the rotating portion 219. The key 203 can be inserted into the notch 205.
[0100] By moving knob 220 in direction K, the outer surface 217b of interlocking part 215 contacts the outer surface of spring 297, and... Figure 20A The spring 297 is compressed in the direction 297b shown. After positioning one or more pins above the rotating part 219, the knob 220 and / or knob 214 are in... Figure 20E Rotate in the direction L shown to align one or more pins with one or more interlocking recesses. For example, pin 213a can be aligned with interlocking part 211a, pin 213b can be aligned with interlocking part 211b, and pin 213c can be aligned with interlocking part 211c. After aligning one or more pins with one or more interlocking recesses, knob 220 can... Figure 20F The pin moves in the direction M shown. At least a portion of one or more pins can respectively enter into and interlock with one or more interlocking portions. For example, at least a portion of pin 213a can be positioned within interlocking portion 211a.
[0101] In one or more situations, spring 297 can depressurize and Figure 20AA force is applied in the direction 297a shown, thereby biasing one or more pins into corresponding one or more interlocking portions. In the interlocked position, a space 221 can be formed to indicate that one or more pins are inserted into the corresponding one or more interlocking portions. In one or more cases, the knob 220 may include one or more ergonomic recesses, such as recesses 220a circumferentially disposed around the knob 220. One or more recesses 220a can be used to facilitate rotation of the knob 220 about the drive shaft 202. In one or more cases, the knob 214 may include one or more ergonomic recesses, such as recesses 214a circumferentially disposed around the knob 214. One or more recesses 214a can be used to facilitate rotation of the knob 214. In one or more cases, one or more recesses 220a of the knob 220 and one or more recesses 214a of the knob 214 can provide visual feedback indicating that one or more pins are aligned with one or more interlocking recesses. For example, when one or more recesses 220a and one or more recesses 214a are aligned with each other and form one or more continuous recesses extending from knob 220 to knob 214, one or more pins are aligned with one or more interlocking recesses.
[0102] As discussed herein, sleeve 218 is configured to lock clamp 236 to head 238 for releasable fixation to bone fastener 222. Sleeve 218 extends along a portion of sleeve 216 and is configured to translate axially relative to sleeve 216. When knob 220 is in Figure 21A When rotating in direction I as shown, sleeve 216 is in Figure 21A and 21B Axial translation in direction B is shown. By axially translating the sleeve 216 in direction B, the fingers 250a, 250b, 250c, and 250d are removed from the sleeve 218. The fingers 250a, 250b, 250c, and 250d can be translated over the head 238 of the fastener 222. In one or more cases, the key portions 242a and 242b of the collet 236 can be aligned with one or more screw planes 240a of the fastener 222. When the knob 220 is in such a position... Figure 21BWhen rotated in direction F as shown, fingers 250a, 250b, 250c, and 250d move into sleeve 218 and are further pushed inward by the force of sleeve 218 engaging collet 236. By engaging sleeve 218 with collet 236, fingers 250a, 250b, 250c, and 250d move from an open position to a closed position around head 238. Knob 220 can be rotated in direction F such that surface 295a of collet 236 and surface 295b of sleeve 218 press against each other, and sleeve 216 and / or 218 are axially rigid relative to drive shaft 202. The rotational force pulls fastener 222 to end 208 of drive shaft 202. After fingers 250a, 250b, 250c, and 250d are engaged with head 238 of fastener 222, collet 236 can be locked to head 238.
[0103] As discussed herein, in assembly, operation, and use, a surgical implant system 200 similar to the systems and methods described herein is employed in conjunction with surgery for treating spinal conditions affecting a segment of the spine in a patient. For example, system 200 may be used in conjunction with surgery for treating a symptom or injury to an affected segment of the spine containing vertebrae. In some embodiments, one or all of the components of system 200 may be delivered as a pre-assembled device or may be assembled in situ. System 200 may be modified, removed, or replaced wholly or partially.
[0104] For example, system 200 can be used for surgical treatment of applicable conditions or injuries in affected segments of the spine and adjacent areas within the body (e.g., vertebrae) (not shown). In some embodiments, system 200 can be used on one or more vertebrae. To treat selected segments of the vertebrae, a medical practitioner obtains access to the surgical site containing the vertebrae in any appropriate manner (e.g., through incisions and tissue retraction). In some embodiments, system 200 can be used with any existing surgical method or technique, including open surgery, micro-open surgery, and minimally invasive surgery involving percutaneous surgical implantation, thereby gaining access to the vertebrae through a micro-incision or a sleeve providing a protected passage to the area. Once access to the surgical site is obtained, specific surgical procedures can be performed to treat spinal conditions.
[0105] An incision is made inside the patient, and a cutting instrument (not shown) creates a surgical pathway for the delivery of implantable components of system 200. Vertebrae and tissue surfaces for aspiration and irrigation of the surgical area can be prepared using a preparation instrument (not shown).
[0106] like Figure 21AAs shown, the surgical instrument 210 can be positioned in a first position such that the chuck 236 is in a biased closed position extending a distance from the end 270 of the sleeve 218. The mating surface 208a of the drive shaft 202 can engage with the mating surface 254 of the fastener 222. The knob 220 is in the position as shown... Figure 21A and 21B The rotation in direction I shown causes the sleeve 216 to rotate as shown in the figure. Figure 18B and 21B The sleeve 216 is translated along axis L1 in direction B. By translating the sleeve 216 in direction B, the chuck 236 can capture the head 238.
[0107] When sleeve 216 moves out of sleeve 218, the fingers 250a, 250b, 250c, and 250d of chuck 236 are in... Figure 21B The fingers extend in direction C to the biased closed position. When the fingers 250a, 250b, 250c, and 250d are translated to the open position above the outer circumferential surface 278 of the fastener 222, the fingers 250a, 250b, 250c, and 250d can extend further in direction C. When the fingers 250a, 250b, 250c, and 250d are translated above surface 278, due to the elastic bias of the fingers 250a, 250b, 250c, and 250d, the fingers 250a, 250b, 250c, and 250d are pushed back as shown. Figure 21B The closed position is shown in direction D. Fingers 250a, 250b, 250c, and 250d can snap together around the head 238, thereby capturing the head 238 within the fingers 250a, 250b, 250c, and 250d. Knob 220 is... Figure 21B Further rotation in direction I as shown causes sleeve 218 to... Figure 21C The sleeve 218 is translated in direction E as shown, causing the end 270 of the sleeve 218 to translate over the chuck 236 and compress the fingers 250a, 250b, 250c, and 250d of the chuck 236. By compressing the fingers 250a, 250b, 250c, and 250d, the fingers 250a, 250b, 250c, and 250d can be tightened around the surface 278 of the head 238 to releasably secure the surgical instrument 210 to the fastener 222, thereby engaging the drive shaft 202 that rotates with the rotation of the knob 214 and / or the knob 220.
[0108] In one or more cases, by Figure 21C Rotating knob 214 and / or knob 220 in direction A as shown can rotate the drive shaft 202. In one or more cases, this can be achieved by... Figure 21CRotating the drive shaft 202 in direction A, by rotating a handle attached to the end 204 of the drive shaft 202 or the drive shaft 202 itself, rotates the drive shaft 202. The handle, drive shaft 202, knob 214, and / or knob 220 can be rotated to apply a torsional force to the fastener 222 and increase the depth of the guide hole and / or secure the fastener 222 to the tissue. As the guide hole depth increases, the shaft 252 engages the cortical bone outer layer, causing the fastener 222 to rotate further about axis L1, which results in the shaft 252 moving through the guide hole and the cortical bone outer layer and into the cancellous bone layer. In some embodiments, the fastener 222 is rotated until the shaft 252 of the fastener 222 penetrates the vertebra to secure the fastener 222 to the tissue. In one or more embodiments, as discussed herein, translational stops 288 and / or depth stops of the surgical instrument 210 can prevent the fastener 222 from penetrating the vertebra beyond a selected limit. 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 cone.
[0109] The components of system 200, including surgical instrument 210 and fastener 222, are used to augment one or more surgical procedures. As described herein, surgical instrument 210 can be positioned in a first unlocked orientation to release fastener 222 from clamp 236. To disengage surgical instrument 210 from fastener 222, knob 220 is turned... Figure 21C Rotate in the opposite direction F as shown, so as to... Figure 21C The sleeve 218 is translated in direction G as shown. Translating the sleeve 218 in direction G releases the compressive force around the chuck 236. Knob 220 is... Figure 21B and 21C Further rotation in the direction F shown causes sleeve 216 to... Figure 18B and 21B The sleeve 216 translates in direction H as shown. When the sleeve 216 translates in direction H, the fingers 250a, 250b, 250c, and 250d move away from the head 238, disengaging from the head 238. The mating surface 208a of the drive shaft 202 can disengage from the mating surface 254 of the fastener 222. It should be noted that rotational directions I and A cause one or more components to move in directions B and / or E, and rotational directions J and A cause one or more components to move in directions G and / or H. However, it should be understood that in one or more other cases, rotational directions I and A cause one or more components to move in directions G and / or H, and rotational directions J and A cause one or more components to move in directions B and / or E.
[0110] Surgical instruments 210 can be reassembled for use in surgical procedures. In some embodiments, system 200 may include a variety of instruments comprising the locking and clamping configurations of this disclosure, such as inserters, expanders, miniaturizers, dilators, tensioners, blades, traction devices, clamps, forceps, elevators, and drills, which may alternatively be sized and dimensional and arranged in a kit.
[0111] After the procedure, surgical instruments 210, surgical instruments and / or tools, assemblies, and non-implantable components of system 200 are removed, and one or more incisions are closed. One or more components of system 200 may be made of a radiation-permeable material, such as a polymer. Radiolabels may be included for identification under X-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgery, and image-guided techniques by means of system 200 can be used to access, view, and repair spinal degeneration or injury. In some embodiments, system 200 may include one or more plates, connectors, and / or bone fasteners for use with a single vertebra or multiple vertebral segments.
[0112] As used in this article, the term “approximately” for numerical values means plus or minus 10% of the value of the number being used.
[0113] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as examples of various embodiments. Other modifications within the scope and spirit of the appended claims will be contemplated by those skilled in the art.
Claims
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 a first channel of the tubular second member; as well as A tubular third member having a fifth end and a sixth end, wherein a portion of the elongated first member and a portion of the tubular second member are positioned within a second channel of the tubular third member; Multiple teeth are provided at the sixth end of the tubular third member for drilling into tissue; The fifth end of the tubular third member includes a first handle rotatably engaged with the third end of the tubular second member to allow axial translation of the tubular third member relative to the tubular second member. The fourth end of the tubular second member includes an expandable member, and the tubular third member has the dual function of penetrating tissue and selectively holding the expandable member in a closed position. The expandable component is a flexible clamp configured to snap around the end of the fastener. The expandable component includes at least one key portion configured to interlock with at least one key portion disposed on the end of a fastener. The key portion of the scalable member includes a surface extending across the inner surface of the chuck. The surface of the key portion of the aforementioned expandable component has a planar shape.
2. The surgical instrument of claim 1, wherein the expandable member of the tubular second member is configured to engage the end of a fastener.
3. 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.
4. The surgical instrument of claim 3, wherein the sixth end of the tubular third member is configured to compress the expandable member of the tubular second member.
5. The surgical instrument of claim 3, wherein the first handle is configured to rotate in a second direction to cause the sixth end of the tubular third member to translate away from the fourth end of the tubular second member.
6. The surgical instrument of claim 5, wherein the sixth end of the tubular third member is configured to release the expandable member that compresses the tubular second member.
7. The surgical instrument of claim 1, wherein the tubular third member is configured to prevent the tubular second member from moving beyond a certain distance.
8. The surgical instrument of claim 7, wherein the tubular third member includes one or more pins projecting into the second channel of the tubular third member, and The tubular second member includes one or more rails positioned on the surface of the tubular second member and configured to receive corresponding pins within the one or more rails.
9. The surgical instrument of claim 1, wherein the elongated first member includes a second handle disposed on a portion of the elongated first member, and wherein the second handle is configured to be detachably coupled to the first handle.
10. The surgical instrument of claim 9, wherein the elongated first member is configured to translate through the second handle.
11. A surgical system comprising: A fastener, the fastener including at least one key portion disposed on the surface of the fastener; Surgical instruments, the surgical instruments comprising: An elongated first member having a first end and a second end, the first end being configured to engage the end of the fastener; A tubular second member having a third end and a fourth end, a portion of the elongated first member being positioned within a first channel of the tubular second member; and A tubular third member having a fifth end and a sixth end, wherein a portion of the elongated first member and a portion of the tubular second member are positioned within a second channel of the tubular third member; Multiple teeth are provided at the sixth end of the tubular third member for drilling into tissue; The fifth end of the tubular third member includes a first handle rotatably engaged with the third end of the tubular second member to allow axial translation of the tubular third member relative to the tubular second member. The fourth end of the tubular second member includes an expandable member having at least one key portion, the at least one key portion of which is configured to interlock with the at least one key portion of the fastener. The tubular third member has the dual function of penetrating tissue and selectively holding the expandable member in a closed position. The expandable component is a flexible clamp configured to snap around the end of the fastener. The key portion of the scalable member includes a surface extending across the inner surface of the chuck. The surface of the key portion of the aforementioned expandable component has a planar shape.
12. The surgical system of claim 11, 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.
13. The surgical system of claim 12, wherein the sixth end of the tubular third member is configured to compress the expandable member of the tubular second member.
14. The surgical system of claim 12, 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.
15. The surgical system of claim 14, wherein the sixth end of the tubular third member is configured to release the expandable member that compresses the tubular second member.
16. The surgical system of claim 11, wherein the tubular third member is configured to prevent the tubular second member from moving beyond a certain distance.
17. The surgical system of claim 16, wherein the tubular third member includes one or more pins projecting into the second channel of the tubular third member, and The tubular second member includes one or more rails positioned on the surface of the tubular second member and configured to receive corresponding pins within the one or more rails.