Patent Publication Number: US-2021177480-A1

Title: Spinal implant system and method

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a spinal implant system and a method for treating a spine. 
     BACKGROUND 
     Spinal pathologies and disorders such as scoliosis, kyphosis, and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility. 
     Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the bone fasteners to the exterior of two or more vertebral members. A surgeon may stabilize the vertebra by using a driver to insert the bone fasteners into the damaged vertebral body and attach the fasteners to one or more rods to help support and stabilize the damaged vertebra. It is sometimes difficult for the surgeon to achieve the required support and stabilization for the damaged vertebral body because the threads of the bone fasteners do not properly engage the vertebral bone. Therefore, the surgeon may insert a bone filler device into the driver to deliver an adhesive material or cement material in and/or around at least one of the bone fasteners using an injection gun that is coupled to the bone filler device to further bond at least one of the fasteners with bone. However, the injection gun often generates back pressure that causes the bone filler device to become disconnected from the driver. As a result, a separate instrument is required to prevent the bone filler device from being disconnected from the driver when the injection gun generates back pressure. Another common method of cement injection uses one hand to hold the bone filler device in place, which acts as resistance to back pressure. A plunger is used by the other hand to distribute the cement. This disclosure describes an improvement over these prior technologies. 
     SUMMARY 
     In one embodiment, a delivery system is provided. The delivery system comprises a first instrument and a second instrument. The first instrument comprises an outer sleeve defining a passageway. The first instrument comprises an inner sleeve having a first end disposed in the passageway and a second end that includes a first mating element. The inner sleeve defines a channel. The second instrument comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body and a second mating element that extends from the body. The second mating element is configured to engage the first mating element to secure the second instrument to the first instrument. In some embodiments, methods are disclosed. 
     In one embodiment, a delivery system is provided. The delivery system comprises an implant, a first instrument and a second instrument. The implant comprises a threaded screw and a head that is coupled to the screw. The screw comprises a bore that extends through opposite ends of the screw. The head has a threaded inner surface. The first instrument comprises an outer sleeve defining a passageway. The first instrument comprises an inner sleeve having a first end that is rotatably disposed in the passageway and a second end that includes a first mating element. The first end comprises a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end comprises a tip that is positioned in the bore to couple the inner sleeve to the screw. The inner sleeve defines a channel. The second instrument comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body and a second mating element that extends from the body. The second mating element engages the first mating element to secure the second instrument to the first instrument such that the second instrument is prevented from translating proximally relative to the first instrument. 
     In one embodiment, a delivery system is provided. The delivery system comprises a bone fastener, a driver, a bone filler device and an injector. The bone fastener comprises a threaded screw and a head that is coupled to the screw. The screw is rotatable relative to the head in multiple planes. The screw comprises an inner surface defining a bore that extends through opposite ends of the screw. The screw comprises an opening that extends through the inner surface and an opposite outer surface of the screw. The head has a threaded inner surface. The driver comprises an outer sleeve defining a passageway. The driver comprises an inner sleeve having a first end that is rotatably disposed in the passageway and a second end that includes a flange. The first end comprises a threaded outer surface that engages the threaded inner surface to couple the inner sleeve to the head. The first end comprises a tip that is positioned in the bore to couple the inner sleeve to the screw. The inner sleeve defines a channel. The bone filler device comprises a hollow shaft that is disposed in the channel and a handle that is coupled to the shaft. The handle comprises a body including a cylindrical portion that is coaxial with the shaft. The cylindrical portion has a threaded outer surface and an inner surface defining an opening that is in communication and coaxial with a lumen of the shaft. The handle comprises a first wing that extends from a first side the body in a cantilevered configuration and a second wing that extends from an opposite second side of the body in a cantilevered configuration. The first wing comprises an extension that extends from the first side and a tab that extends from the extension. The second wing comprises an extension that extends from the second side and a tab that extends from the extension of the second wing. The extensions each extend parallel to a longitudinal axis defined by the shaft and the tabs each extend perpendicular to the longitudinal axis. The tabs engage the flange to secure the bone filler device to the driver such that the bone filler device is prevented from translating proximally relative to the driver. The injector is coupled to the handle and comprises bone cement therein. The injector is configured to deliver the bone cement through the channel and into the bore. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 2  is a side view of one embodiment of a component of the surgical system shown in  FIG. 1  in accordance with the principles of the present disclosure; 
         FIG. 3  is a side, cross sectional view the component shown in  FIG. 2 ; 
         FIG. 4  is an enlarged side view of a portion of the component shown in  FIG. 2 ; 
         FIG. 5  is an enlarged, cross sectional side view of a portion of the component shown in  FIG. 2 ; 
         FIG. 6  is a side view of one embodiment of a component of the surgical system shown in  FIG. 1  in accordance with the principles of the present disclosure; 
         FIG. 7  is a side, cross sectional view of the component shown in  FIG. 6 ; 
         FIG. 8  is an enlarged side view of a portion of the component shown in  FIG. 6 ; 
         FIG. 9  is an enlarged side view of a portion of the components of the surgical system shown in  FIG. 1 , with the components in an unassembled configuration; 
         FIG. 10  an enlarged, cross sectional side view of a portion of components of the surgical system shown in  FIG. 1 , with the components in an unassembled configuration; 
         FIG. 11  is an enlarged, cross sectional side view of a portion of the surgical system shown in  FIG. 1 , with the components in an unassembled configuration; 
         FIG. 12  is an enlarged side view of a portion of components of the surgical system shown in  FIG. 1 , with the components in an assembled configuration; 
         FIG. 13  is an enlarged, cross sectional side view of a portion of components of the surgical system shown in  FIG. 1 , with the components in an assembled configuration; 
         FIG. 14  is a plan view of one embodiment of the surgical system shown in  FIG. 1  in accordance with the principles of the present disclosure; 
         FIG. 15  is a plan view of one embodiment of the surgical system shown in  FIG. 1  in accordance with the principles of the present disclosure; 
         FIG. 16  is a plan view of one embodiment of the surgical system shown in  FIG. 1  in accordance with the principles of the present disclosure; 
         FIG. 17  is a side view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
         FIG. 18  is a side view of one embodiment of a component of the surgical system shown in  FIG. 17  in accordance with the principles of the present disclosure; 
         FIG. 19  is a side, cross sectional view of the component shown in  FIG. 18 ; 
         FIG. 20  is an enlarged side view of a portion of the component shown in  FIG. 18 ; and 
         FIG. 21  is an enlarged, cross sectional side view of a portion of the component shown in  FIG. 18 . 
     
    
    
     DETAILED DESCRIPTION 
     The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a delivery system and a method for treating a spine. In some embodiments, the systems and methods of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. 
     A cement delivery gun creates back pressure when used in connection with a predicate bone filler device. A current fenestrated screw system relies on an extra instrument to counteract the back pressure generated by the cement delivery system gun. On the other hand, in various embodiments, the delivery system of the present disclosure simplifies the procedure by removing unnecessary steps while still providing the function needed. In some embodiments, the present delivery system eliminates the need for a separate instrument to secure a bone filler device to its guide/driver and includes a handle having a specific shape developed to retain proper connection between the handle and the guide/driver during cement application. In some embodiments, the handle includes wings having a shape that allows both easy attachment to an undercut in the guide/driver. The handle also provides an ergonomic feature that allows simple release the bone filler device from the guide/driver. In some embodiments, a distal end of the handle having a conical shape that helps facilitate axilization of the bone filler device ensuring proper assembly of the handle with the guide/driver by aligning the handle with the guide/driver. In some embodiments, the handle and/or guide/drive will create clicking during assembly of the handle with the guide/driver to indicate that the handle has been properly assembled with the guide/driver. 
     In some embodiments, the delivery system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, kyphosis, and other curvature abnormalities, tumor and fractures. In some embodiments, the delivery system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed delivery system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The delivery system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The delivery system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration. 
     The delivery system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, 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 shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification 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 is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”. 
     As used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or 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 it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. In some embodiments, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
     The following discussion includes a description of a delivery system and related components and methods of employing the delivery system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to  FIGS. 1-21 , there are illustrated components of a delivery system, such as, for example, a delivery system  30 . 
     The components of delivery system  30  can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of delivery system  30 , individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4  polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. 
     Various components of delivery system  30  may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of delivery system  30 , individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of delivery system  30  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
     Delivery system  30  is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or a spinal implant, such as, for example, a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine. 
     Delivery system  30  includes a first instrument, such as, for example, a driver  32 . Driver  32  includes a sleeve, such as, for example, an outer sleeve  34  that extends along a longitudinal axis L 1  between an end  36  and an opposite end  38 . Sleeve  34  has an inner surface  40  defining a passageway  42 , as best shown in  FIG. 3 . Passageway  42  is coaxial with axis L 1  and extends the entire length of sleeve  34  such that passageway  42  extends through opposite end surfaces of ends  36 ,  38 . In some embodiments, passageway  42  has a circular diameter. In some embodiments, passageway  42  has a uniform diameter along the entire length of passageway  42 . In some embodiments, passageway  42  may be disposed at alternate orientations, relative to axis L 1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, passageway  42  may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. 
     Driver  32  includes a sleeve, such as, for example, an inner sleeve  44  rotatably disposed in passageway  42  such that sleeve  44  is coaxial with axis L 1 . Sleeve  44  extends between an end  46  and an opposite end  48  that is disposed in passageway  42 . End  46  includes a first mating element, such as, for example, a flange  50  that is spaced apart from a flange  52  by an undercut, such as, for example, a recess  54 . Flange  50  includes opposite surfaces  56 ,  58  that each extend perpendicular to axis L 1  and surfaces  60 ,  62  that are each positioned between surfaces  56 ,  58 , as best shown in  FIGS. 4 and 5 . Surface  56  defines the end surface of end  46 . Surface  60  extends transverse to axis L 1  and surface  62  extends parallel to axis L 1 . 
     Sleeve  44  includes a body  64  having an inner surface  66  that defines a channel  68 , as best shown in  FIG. 3 . Channel  68  is coaxial with axis L 1  and extends the entire length of sleeve  44  such that channel  68  extends through surface  56  and an opposite end surface of end  48 . In some embodiments, channel  68  has a circular diameter. In some embodiments, channel  68  has a uniform diameter along the entire length of channel  68 . In some embodiments, channel  68  may be disposed at alternate orientations, relative to axis L 1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, channel  68  may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. 
     End  48  includes a tip  70  that is connected with body  64 , as best shown in  FIG. 3 . In some embodiments, tip  70  is removably connected with body  64  such that tip  70  is disposable. In such embodiments, tip  70  may be provisionally fixed with body  64  such that rotation of body  64  also rotates tip  70 . In some embodiments, tip  70  is variously connected with body  64 , such as, for example, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element. In some embodiments, tip  70  is integrally and/or monolithically formed with body  64  such that tip  70  cannot be removed from body  64  without breaking body  64  and/or tip  70 . Tip  70  extends between an end  72  and an opposite end  74 . Tip  70  includes an inner surface  76  defining a bore  78  that is coaxial with axis L 1  and extends the entire length of tip  70  such that bore  78  extends through opposite end surfaces of ends  72 ,  74 . In some embodiments, bore  78  has a circular diameter. In some embodiments, bore  78  has a uniform diameter along the entire length of bore  78 . In some embodiments, bore  78  may be disposed at alternate orientations, relative to axis L 1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, bore  78  may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. End  72  is positioned in channel  68  such that bore  78  is in communication and coaxial with channel  68 . End  74  defines a drive portion configured for engagement with an implant, such as, for example, a bone fastener  80 , as discussed herein. In some embodiments, the drive portion may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion of fastener  80 . In some embodiments, tip  70  includes a threaded outer surface that is configured to engage threads of fastener  80  to couple sleeve  44  to fastener  80 , as discussed herein. 
     Fastener  80  includes a head, such as, for example, an implant receiver  84  and a screw shaft  86  that is coupled to receiver  84 . Implant receiver  84  extends parallel to axis L 1  when fastener  80  is coupled to sleeve  44 . Implant receiver  84  includes a pair of spaced apart arms  88 ,  90  that define an implant cavity  92  therebetween configured for disposal of a spinal construct, such as, for example, a spinal rod. Arms  88 ,  90  each extend parallel to axis L 1  when fastener  80  is coupled to sleeve  44 . In some embodiments, arm  88  and/or arm  90  may be disposed at alternate orientations, relative to axis L 1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. Arms  88 ,  90  each include an arcuate outer surface extending between a pair of side surfaces. At least one of the outer surfaces and the side surfaces of arms  88 ,  90  have at least one recess or cavity therein configured to receive an insertion tool, compression instrument and/or instruments for inserting and tensioning bone fastener  80 . 
     Arm  88  includes a break away tab  94  that is frangibly connected to arm  88  ( FIG. 3 ) such that manipulation of tab  94  relative to arm  88  can fracture and separate tab  94  from arm  88  at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tab  94  and resistance increases, for example, the predetermined torque and force limit is approached. Arm  90  includes a break away tab  96  that is frangibly connected to arm  90  such that manipulation of tab  96  relative to arm  90  can fracture and separate tab  96  from arm  90  at a predetermined force and/or torque limit, as described herein. In some embodiments, as force and/or torque is applied to tab  96  and resistance increases, for example, the predetermined torque and force limit is approached. 
     In some embodiments, tabs  94 ,  96  can fracture and separate at a predetermined force or torque limit, which may be in a range of approximately 2 Newton meters (N-m) to 8 Nm. In some embodiments, tabs  94 ,  96  and arms  88 ,  90  may have the same or alternate cross section configurations, may be fabricated from a homogenous material or heterogeneously fabricated from different materials, and/or alternately formed of a material having a greater degree, characteristic or attribute of plastic deformability, frangible property and/or break away quality to facilitate fracture and separation of tabs  94 ,  96  from arms  88 ,  90 . 
     Cavity  92  is substantially U-shaped. In some embodiments, all or only a portion of cavity  92  may have alternate cross section configurations, such as, for example, closed, V-shaped, W-shaped, oval, oblong triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. Implant receiver  84  includes thread forms configured for engagement with a coupling member, such as, for example, a setscrew to retain a spinal rod within cavity  92 . The thread forms of implant receiver  84  may also engage threaded outer surface  82  of tip  70  to couple sleeve  44  to implant receiver  84 , as discussed herein. In some embodiments, the inner surface of implant receiver  84  may be disposed with the coupling member and/or tip  70  in alternate fixation configurations, such as, for example, friction fit, pressure fit, locking protrusion/recess, locking keyway and/or adhesive. In some embodiments, all or only a portion of the inner surface of implant receiver  84  may have alternate surface configurations to enhance engagement with a spinal rod, a setscrew and/or tip  70 , such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, implant receiver  92  may include alternate configurations, such as, for example, closed, open and/or side access. In some embodiments, bone fastener  80  includes a crown  98  configured to facilitate positioning of a spinal rod. 
     Implant receiver  84  defines a cavity  100  configured for disposal of a head of screw shaft  86 , as described herein. Screw shaft  86  includes a socket, such as, for example, a tool engaging portion  102  configured to engage the drive portion of end  74 . Screw shaft  86  includes an outer surface having an external thread form. In some embodiments, the external thread form may include a single thread turn or a plurality of discrete threads. Screw shaft  86  includes an inner surface  104  defining a bore  106  that extends the entire length of screw shaft  86 . When the drive portion of end  74  engages tool engaging portion  102 , bore  78  is in communication and coaxial with bore  106 . In some embodiments, screw shaft  86  includes one or a plurality of openings that each extend through surface  104  and an opposite outer surface  108  of screw shaft  86  such that a material, such as, for example, bone cement disposed in bore  106  can exit bore  106  through one of the openings that extend through surfaces  104 ,  108  and/or through an opening  110  in a distal end of screw shaft  86  that is coaxial with axis L 1  when fastener  80  is coupled to sleeve  44 . 
     In some embodiments, implant receiver  84  is manually engageable with screw shaft  86  in a non-instrumented assembly, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly of implant receiver  84  and screw shaft  86  includes coupling without use of separate and/or independent instrumentation engaged with the components to effect assembly. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver  84  and screw shaft  86  and forcibly assembling the components. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver  84  and screw shaft  86  and forcibly snap fitting the components together, as described herein. In some embodiments, manual engagement and/or non-instrumented assembly includes a practitioner, surgeon and/or medical staff grasping implant receiver  84  and screw shaft  86  and forcibly pop fitting the components together and/or pop fitting implant receiver  84  onto screw shaft  86 , as described herein. In some embodiments, a force in a range of 2-50 N is required to manually engage implant receiver  84  and screw shaft  86  and forcibly assemble the components. In some embodiments, a force in a range of 5-10 N is required to manually engage implant receiver  84  and screw shaft  86  and forcibly assemble the components. 
     In some embodiments, implant receiver  84  is connectable with screw shaft  86  such that screw shaft  86  is pivotable and/or rotatable relative to implant receiver  84  in a plurality of planes. In some embodiments, implant receiver  84  is connectable with screw shaft  86  to include various configurations, such as, for example, a posted screw, a pedicle screw, a bolt, a bone screw for a lateral plate, an interbody screw, a uni-axial screw (UAS), a fixed angle screw (FAS), a multi-axial screw (MAS), a side loading screw, a sagittal adjusting screw (SAS), a transverse sagittal adjusting screw (TSAS), an awl tip (ATS), a dual rod multi-axial screw (DRMAS), midline lumbar fusion screw and/or a sacral bone screw. 
     To connect driver  32  with fastener  80 , tip  70  is inserted into implant cavity  92  and sleeve  44  is rotated relative to sleeve  34  such that the threads on outer surface  82  of tip  70  mate with the thread forms of implant receiver  84  to couple sleeve  44  with receiver  84 . Sleeve  44  is further rotated relative to sleeve  34  such that the drive portion of end  74  is positioned in tool engaging portion  102  to couple sleeve  44  with screw  86 . In some embodiments, the threads on outer surface  82  of tip  70  mate with the thread forms of implant receiver  84  at the same time that the drive portion of end  74  is positioned in tool engaging portion  86  to position receiver  84  relative to screw  86  such that receiver  84  and screw  86  extend parallel to axis L 1  and maintain such positioning as fastener  80  is driven into bone or other tissue using driver  32 , as discussed herein. That is, mating the threads on outer surface  82  of tip  70  with the thread forms of implant receiver  84  at the same time that the drive portion of end  74  is positioned in tool engaging portion  86  prevents receiver  84  from pivoting relative to screw  86 . 
     Delivery system  30  includes a second instrument, such as, for example, a bone filler device  112 . Device  112  includes a shaft  114  and a handle  116  that is coupled to shaft  114 . In some embodiments, handle  116  is permanently fixed to shaft  114  such that handle  116  cannot be removed from shaft  114  without breaking handle  116  and/or shaft  114 . In some embodiments, handle  116  is integrally and/or monolithically formed with shaft  114 . In some embodiments, handle  116  is removably connected with shaft  114  such that handle  116  can be removed from shaft  114  without breaking handle  116  and/or shaft  114 . 
     Shaft  114  is configured for disposal in channel  68  and extends along a longitudinal axis L 2  between an end  118  and an opposite end  120 . Handle  116  is connected with end  118 . In some embodiments, shaft  114  is tapered from end  118  to end  120  such that end  118  has a minimum diameter that is greater than a minimum diameter of end  120 . In some embodiments, shaft  114  has a uniform diameter along the entire length of shaft  114 . Shaft  114  comprises an inner surface  122  that defines a lumen  124 , as best shown in  FIG. 7 . Lumen  124  is coaxial with axis L 2  and extends the entire length of shaft  114  such that lumen  124  extends through opposite end surfaces of ends  118 ,  120 . In some embodiments, lumen  124  has a circular diameter. In some embodiments, lumen  124  has a diameter that tapers along the length of shaft  114 . In some embodiments, lumen  124  may be disposed at alternate orientations, relative to axis L 2 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, lumen  124  may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. 
     Handle  116  comprises a body  126  including a cylindrical portion  128  that is coaxial with shaft  114  and axis L 2 . Cylindrical portion  128  has a threaded outer surface  130  and an opposite inner surface  132  defining an opening  134  that is in communication and coaxial with lumen  124 , as best shown in  FIG. 7 . Body  126  comprises a conical portion  136  opposite cylindrical portion  128 . Conical portion  136  is configured for disposal in channel  68  to connect handle  116  with sleeve  44 , as discussed herein. Conical portion  136  helps facilitate axialization of device  112  relative to driver  32  to ensure proper assembly. 
     Handle  116  comprises a second mating element that includes a first wing  138  that extends from a first side  140  of body  126  in a cantilevered configuration and a second wing  142  that extends from an opposite second side  144  of body  126  in a cantilevered configuration. Wing  138  comprises an extension  146  that extends from first side  140 , a gripping portion  148  that extends from extension  146  and a tab  150  that extends from extension  146 . Wing  142  comprises an extension  152  that extends from second side  144 , a gripping portion  154  that extends from extension  152  and a tab  156  that extends from extension  152 . Extensions  146 , 152  each extend parallel to axis L 2 . Gripping portions  148 ,  154  each extend transverse to axis L 2 . Tabs  150 ,  156  each extend perpendicular to axis L 2 . Tab  150  includes a surface  150   a  that extends parallel to axis L 2  and tab  156  includes a surface  156   a  that extends parallel to axis L 2 . Surface  150   a  faces surface  156   a . Tab  150  includes a surface  150   b  that extends perpendicular to axis L 2  and tab  156  includes a surface  156   b  that extends perpendicular to axis L 2 . Tabs  150 ,  156  are configured to engage flange  50  to secure the device  112  to driver  32  such that device  112  is prevented from translating axially relative to driver  32  in the direction shown by arrow A in  FIG. 12 . Surface  150   a  is spaced a first distance apart from surface  156   a  when no forces are applied to wings  138 ,  142 . Wings  138 ,  142  are configured to deflect relative to body  126 . For example, a force may be applied to gripping portion  148  to move gripping portion  148  relative to body  126  in the direction shown by arrow B in  FIG. 8  and a force may be applied to gripping portion  154  to move gripping portion  154  relative to body  126  in the direction shown by arrow C in  FIG. 8  such that tabs  150 ,  156  move away from one another and surface  150   a  is spaced an increased second distance apart from surface  156   a . In some embodiments, wings  138 ,  142  are resiliently biased inwardly such that after the forces are removed from gripping portions  148 ,  154  tabs  150 ,  156  move toward one another such that surface  150   a  is spaced the first distance apart from surface  156   a.    
     To connect device  112  with sleeve  44 , shaft  114  is inserted into channel  68  such that axis L 2  is coaxial with axis L 1 . Device  112  is then translated axially relative to sleeve  44  in the direction shown by arrow D in  FIG. 9  until conical portion  136  is positioned within channel  68 . As device  112  translates axially relative to sleeve  44  in the direction shown by arrow D in  FIG. 9 , surface  150   a  of tab  150  slides along surface  60  of flange  50 , as shown in  FIG. 11  and surface  156   a  of tab  156  slides along surface  60 . As surfaces  150   a ,  156   a  slide along surface  60 , wings  138 ,  142  deflect outwardly from body  126  such that the distance between surfaces  150   a ,  156   a  increase from the first distance to a second distance. Device  112  is further translated axially relative to sleeve  44  in the direction shown by arrow D in  FIG. 9  when surfaces  150   a ,  156   a  are spaced apart by the second distance such that surfaces  150   a ,  156   a  slide along surface  62  of flange  50 . Device  112  is further translated axially relative to sleeve  44  in the direction shown by arrow D in  FIG. 9  such that tabs  150 ,  156  are aligned with recess  54 . The inward bias of wings  138 ,  142  causes tabs  150 ,  156  to move toward one another such that surface  150   a  is spaced the first distance apart from surface  156   a  and surfaces  150   b ,  156   b  engage surface  58  of flange  50 , as shown in  FIGS. 12 and 13 , to prevent device  112  from translating axially relative to sleeve  44  in the direction shown by arrow A in  FIG. 12 . In some embodiments, tabs  150 ,  156  create a clicking sound when tabs  150 ,  156  to move toward one another and surfaces  150   b ,  156   b  engage surface  58  of flange  50 , which indicates the device  112  is properly assembled with sleeve  44 . 
     To remove device  112  from sleeve  44 , a force is applied to gripping portion  148  to move gripping portion  148  relative to body  126  in the direction shown by arrow B in  FIG. 8  and a force is applied to gripping portion  154  to move gripping portion  154  relative to body  126  in the direction shown by arrow C in  FIG. 8  such that surface  150   a  is spaced the second distance apart from surface  156   a . Device  112  is translated axially relative to sleeve  44  in the direction shown by arrow A in  FIG. 12  such that surfaces  150   a ,  156   a  slide along surface  62 . Device  112  may be translated axially relative to sleeve  44  in the direction shown by arrow A in  FIG. 12  until shaft  114  is removed from channel  68 . 
     In assembly, operation and use, driver  32  is connected with fastener  80  as discussed herein. Access to the surgical site is obtained and the particular surgical procedure is performed. The components of delivery system  30  are employed to augment the surgical treatment. For example, fastener  80  may be inserted into bone or other tissue with driver  32 , for example via clockwise or counterclockwise rotation of sleeve  44  relative to sleeve  34 . Device  112  is connected with driver  32  either before or after fastener  80  is inserted into bone or other tissue. 
     In one embodiment, shown in  FIGS. 14 and 15 , bone filler material, such as, for example, bone cement is inserted through opening  134  and into lumen  124 . The bone filler material may be inserted into lumen  124  before or after device  112  is connected with driver  32 . A plunger  158  is aligned with opening  134 , as shown in  FIG. 14 . Plunger  158  is then translated relative to handle  116  in the direction shown by arrow E in  FIG. 15  such that plunger  158  pushes the bone filler material through lumen  124  and bores  78 ,  106  and the bone filler material exits screw  86  via one or more openings in screw  86 . As the bone filler material cures, it will bond screw  86  with bone or other tissue. Upon completion of a surgical procedure, plunger  158  may be removed from device  112 , and driver  32  is removed from the surgical site. In some embodiments, device  112  is disengaged from driver  32  either before or after driver  32  is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity  92  after driver  32  is removed from the surgical site and a setscrew is engaged with receiver  84  such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms  88 ,  90 . The setscrew is rotated relative to receiver  84  until the setscrew engages the rod to fix the rod relative to receiver  84 . 
     In one embodiment, shown in  FIG. 16 , delivery system  30  includes a cement delivery system  160  having a cartridge  162  that is connected to handle  112  by a luer lock  164  and a cement delivery gun  166  that is connected to cartridge  162 . Threads of luer lock  164  are mated with threads of surface  130  to connect cartridge  162  to handle  112 . Cartridge  162  is loaded with a bone filler material, such as, for example, bone cement either before or after cartridge  162  is connected to handle  112 . An actuator, such as, for example, a trigger handle of cement delivery gun  166  is activated to move the bone filler material through lumen  124  and bores  78 ,  106  such that the bone filler material exits screw  86  via one or more openings in screw  86 . Engagement of surfaces  150   b ,  156   b  prevents device  112  from translating axially relative to sleeve  44  in the direction shown by arrow A in  FIG. 12  due to back pressure generated by cement delivery gun  166 . As the bone filler material cures, it will bond screw  86  with bone or other tissue. Upon completion of a surgical procedure, cement delivery system  160  may be removed from device  112 , and driver  32  is removed from the surgical site. In some embodiments, device  112  is disengaged and/or disconnected from driver  32  either before or after driver  32  is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity  92  after driver  32  is removed from the surgical site and a setscrew is engaged with receiver  84  such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms  88 ,  90 . The setscrew is rotated relative to receiver  84  until the setscrew engages the rod to fix the rod relative to receiver  84 . 
     Delivery system  30  can include one or a plurality of bone fasteners such as those described herein and/or fixation elements, which may be employed with a single vertebral level or a plurality of vertebral levels. In some embodiments, the bone fasteners may be engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners and/or fixation elements may include one or a plurality of multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uni-planar screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts. In some embodiments, system  30  may comprise various instruments including the configuration of the present disclosure, such as, for example, inserters, extenders, reducers, spreaders, distractors, blades, retractors, clamps, forceps, elevators and drills, which may be alternately sized and dimensioned, and arranged as a kit, according to the requirements of a particular application. 
     In some embodiments, delivery system  30  includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of delivery system  30 . In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae. The components of delivery system  30  can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration. 
     In one embodiment, shown in  FIGS. 17-21 , delivery system  30  includes a driver  168  that is similar to driver  32 . Driver  168  includes an outer sleeve  170  having a lower portion  172  and an upper portion  174  that is connected with lower portion  172 . Lower portion  172  extends along a longitudinal axis L 3  between an end  176  and an opposite end  178 . End  176  includes a circumferential cutout  180  configured for disposal of an end  182  of upper portion  174  to connect upper portion  174  with lower portion  172 . In some embodiments, upper portion  174  is connected with lower portion  172  to provisionally fix upper portion  174  relative to lower portion  172  such that rotation of upper portion  174  about axis L 3  also rotates lower portion  172  about axis L 3 . In some embodiments, upper portion  174  can be variously connected with lower portion  172 , such as, for example, monolithic, integral connection, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element. End  178  includes a tip  184  defining a drive portion configured for engagement with an implant, such as, for example, bone fastener  80 , as discussed herein. In some embodiments, the drive portion may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion tool engaging portion  102  of fastener  80 . 
     Upper portion  174  includes an end  186  opposite end  182 . End  186  includes a first mating element, such as, for example, a flange  188  that is similar to flange  50 . Flange  188  is spaced apart from a flange  190  by an undercut, such as, for example, a recess  192 . Flange  188  includes opposite surfaces  194 ,  196  that each extend perpendicular to axis L 3  and surfaces  198 ,  200  that are each positioned between surfaces  194 ,  196 , as best shown in  FIGS. 20 and 21 . Surface  194  defines an end surface of end  186 . Surface  198  extends transverse to axis L 3  and surface  200  extends parallel to axis L 3 . 
     Lower portion  172  includes an inner surface  202  defining a passageway  204  and upper portion  174  includes an inner surface  206  defining a channel  208  that is in communication and coaxial with passageway  204 . Passageway  204  and channel  208  are configured for disposal of an inner sleeve  210  such that sleeve  210  is rotatable relative to sleeve  170  about axis L 3 . Sleeve  210  includes an end  212  and an opposite end  214  having a threaded outer surface  228 . A distal portion of end  212  is positioned in passageway  204  and a proximal portion  216  of end  212  is positioned in channel  208 . Proximal portion  216  includes an inner surface  218  defining a socket  220 . In some embodiments, socket  220  may include a square, triangular, polygonal, star or hexalobe cross sectional configuration configured engage a correspondingly shaped portion of a thumbwheel  222 , as discussed herein. 
     Upper portion  174  includes a window  224  that is configured to allow visualization of a portion of device  112  and a window  226  that is configured to allow grasping of thumbwheel  222 . Thumbwheel  222  includes a bit (not shown) disposed in socket  220 . The bit has a shape that corresponds to the shape of socket  220  such that rotation of thumbwheel  222  relative to sleeve  170  about axis L 3  also rotates sleeve  210  relative to sleeve  170  about axis L 3 . 
     To connect driver  168  with fastener  80 , thumbwheel  222  is rotated relative to sleeve  170  about axis L 3  in a first rotational direction, such as, for example clockwise or counterclockwise. Rotation of thumbwheel  222  relative to sleeve  170  about axis L 3  in the first rotational direction causes rotation of sleeve  210  relative to sleeve  170  about axis L 3  in the first rotational direction. As sleeve  210  rotates relative to sleeve  170  about axis L 3  in the first rotational direction, the threads on surface  228  of sleeve  210  mate with the threads on the inner surfaces of arms  88 ,  90  of fastener  80 . Further rotation of sleeve  210  relative to sleeve  170  about axis L 3  in the first rotational direction causes sleeve  210  to translate axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19 . As sleeve  210  translates axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19 , tip  184  is inserted into tool engaging portion  102  of screw  86 . Simultaneous engagement of tip  184  with tool engaging portion  102  and the threads on surface  228  of sleeve  210  with the threads on the inner surfaces of arms  88 ,  90  of fastener  80  prevents screw  86  from pivoting relative to receiver  84 . 
     To remove driver  168  from fastener  80 , thumbwheel  222  is rotated relative to sleeve  170  about axis L 3  in an opposite second rotational direction, such as, for example clockwise or counterclockwise. Rotation of thumbwheel  222  relative to sleeve  170  about axis L 3  in the second rotational direction causes rotation of sleeve  210  relative to sleeve  170  about axis L 3  in the second rotational direction. As sleeve  210  rotates relative to sleeve  170  about axis L 3  in the second rotational direction, sleeve  210  translates axially relative to sleeve  170  in the direction shown by arrow G in  FIG. 19 . As sleeve  210  translates axially relative to sleeve  170  in the direction shown by arrow G in  FIG. 19 , tip  184  moves out of tool engaging portion  102  of screw  86  and the threads on surface  228  of sleeve  210  disengage the threads on the inner surfaces of arms  88 ,  90  of fastener  80 , at which point driver  168  can be fully removed from fastener  80 . 
     In assembly, operation and use, driver  168  is connected with fastener  80  as discussed herein. Access to the surgical site is obtained and the particular surgical procedure is performed. The components of delivery system  30  are employed to augment the surgical treatment. For example, fastener  80  may be inserted into bone or other tissue with driver  168 , for example via clockwise or counterclockwise rotation of sleeve  170 . 
     Device  112  is connected with driver  168  either before or after fastener  80  is inserted into bone or other tissue. To connect device  112  with driver  168 , shaft  114  is inserted into channel  208  such that axis L 3  is coaxial with axis L 1 . Device  112  is then translated axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19  until shaft  114  extends through thumbwheel  222  and conical portion  136  is positioned within channel  208 . As device  112  translates axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19 , surface  150   a  of tab  150  slides along surface  198  of flange  188  and surface  156   a  of tab  156  slides along surface  198 . As surfaces  150   a ,  156   a  slide along surface  198 , wings  138 ,  142  deflect outwardly from body  126  such that the distance between surfaces  150   a ,  156   a  increase from the first distance to the second distance. Device  112  is further translated axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19  when surfaces  150   a ,  156   a  are spaced apart by the second distance such that surfaces  150   a ,  156   a  slide along surface  200  of flange  188 . Device  112  is further translated axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19  such that tabs  150 ,  156  are aligned with recess  198 . The inward bias of wings  138 ,  142  causes tabs  150 ,  156  to move toward one another such that surface  150   a  is spaced the first distance apart from surface  156   a  and surfaces  150   b ,  156   b  engage surface  196  of flange  188 , as shown in  FIG. 17  to prevent device  112  from translating axially relative to sleeve  170  in the direction shown by arrow G in  FIG. 19 . In some embodiments, tabs  150 ,  156  create a clicking sound when tabs  150 ,  156  to move toward one another and surfaces  150   b ,  156   b  engage surface  196  of flange  188 , which indicates the device  112  is properly assembled with sleeve  170 . 
     In one embodiment, bone filler material, such as, for example, bone cement is inserted through opening  134  and into lumen  124 . The bone filler material may be inserted into lumen  124  after device  112  is connected with driver  168 . Plunger  158  is aligned with opening  134 . Plunger  158  is then translated relative to handle  116  in the direction shown by arrow F in  FIG. 19  such that plunger  158  pushes the bone filler material through lumen  124 , an aperture  230  that extends through tip  184  and bore  106  such that the bone filler material exits screw  86  via one or more openings in screw  86 . As the bone filler material cures, it will bond screw  86  with bone or other tissue. Upon completion of a surgical procedure, plunger  158  may be removed from device  112 , and driver  168  is removed from the surgical site. In some embodiments, device  112  is disengaged from driver  168  either before or after driver  168  is removed from the surgical site. To remove device  112  from sleeve  170 , a force is applied to gripping portion  148  to move gripping portion  148  relative to body  126  in the direction shown by arrow B in  FIG. 8  and a force is applied to gripping portion  154  to move gripping portion  154  relative to body  126  in the direction shown by arrow C in  FIG. 8  such that surface  150   a  is spaced the second distance apart from surface  156   a . Device  112  is translated axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19  such that surfaces  150   a ,  156   a  slide along surface  200 . Device  112  may be translated axially relative to sleeve  170  in the direction shown by arrow F in  FIG. 19  until shaft  114  is removed from channel  208 . In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity  92  after driver  168  is removed from the surgical site and a setscrew is engaged with receiver  84  such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms  88 ,  90 . The setscrew is rotated relative to receiver  84  until the setscrew engages the rod such that the rod is fixed relative to receiver  84 . 
     In one embodiment, threads of luer lock  164  are mated with threads of surface  130  to connect cartridge  162  to handle  112 . Cartridge  162  is loaded with a bone filler material, such as, for example, bone cement either before or after cartridge  162  is connected to handle  112 . The trigger handle of cement delivery gun  166  is activated to move the bone filler material through lumen  124 , aperture  230  and bore  106  such that the bone filler material exits screw  86  via one or more openings in screw  86 . As the bone filler material cures, it will bond screw  86  with bone or other tissue. Upon completion of a surgical procedure, cement delivery system  160  may be removed from device  112 , and driver  168  is removed from the surgical site. In some embodiments, device  112  is disengaged from driver  168  either before or after driver  168  is removed from the surgical site. In some embodiments, a spinal construct, such as, for example, a spinal rod is inserted into implant cavity  92  after driver  168  is removed from the surgical site and a setscrew is engaged with receiver  84  such that threads on an outer surface of the setscrew engage the threads on the inner surfaces of arms  88 ,  90 . The setscrew is rotated relative to receiver  84  until the setscrew engages the rod such that the rod is fixed relative to receiver  84 . 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.