The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for accessing a surgical site to facilitate treatment.
Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, 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 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 fusion, fixation, discectomy, laminectomy and implantable prosthetics. Surgical retractors may be employed during a surgical treatment to provide access and visualization of a surgical site. Such retractors space apart and support tissue and/or other anatomical structures to expose anatomical structures adjacent the surgical site and/or provide a surgical pathway to the surgical site. This disclosure describes an improvement over these prior art technologies.
In one embodiment, a surgical instrument is provided. The surgical instrument includes a first member comprising a body including a first portion comprising a first extension defining a first longitudinal axis. The body comprises a second portion including a projection defining a second longitudinal axis extending transverse to the first longitudinal axis. The projection comprises a flange. A second member comprises a first portion including a second extension and a second portion comprising an opening. The projection extends through the opening. The second member is movable between a first configuration in which the flange is positioned within the opening and the second extension extends parallel to the first longitudinal axis and a second configuration in which the flange is positioned outside of the opening and the second extension extends transverse to the first longitudinal axis. In some embodiments, systems and methods are provided.
The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
The exemplary embodiments of a 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 surgical system and method for accessing a surgical site to facilitate treatment. In one embodiment, the surgical system includes a surgical instrument, such as, for example, a cannula that reduces costs and provides unique features that address unmet needs. In some embodiments, the surgical instrument includes components made from molded plastic.
In some embodiments, the surgical instrument includes one or a plurality of light sources, such as, for example, light emitting diodes (LEDs) for maximizing visualization of target tissues through a small incision, eliminating the need for expensive microscopes for surgery. In some embodiments, the plurality of light sources illuminate a patient's anatomy, thereby increasing effective visualization. In some embodiments, the surgical instrument includes one or a plurality of light sources between proximal and distal ends of the surgical instrument. In some embodiments, the surgical instrument includes light sources, such as, for example, light pipes for increasing effective visualization. In some embodiments, the surgical instrument includes a power source, such as, for example, a battery to provide power to a light source, for example. In some embodiments, the battery is a standard small disposable or rechargeable battery, such as, for example, a watch battery. In some embodiments, the battery is disposed in a handle of the surgical instrument. In some embodiments, the surgical instrument includes a push clip to deploy a retractable cannula. In some embodiments, the surgical instrument is made entirely from molded plastic. In some embodiments, the surgical instrument is configured to be disposable.
In some embodiments, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, 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 surgical 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, lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. 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 surgical 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 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. Also, 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”.
Further, 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. Also, 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 surgical system and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to
The components of surgical system 20 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of surgical system 20, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 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 surgical system 20 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 surgical system 20, 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 surgical system 20 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
Cannula 22 includes a member 24 comprising a body 26 including a portion 28 and a portion 30. Portion 28 comprises an extension 32 defining a longitudinal axis A. Extension 32 extends away from a bottom surface of body 26. Extension 32 comprises an end wall 34 extending between opposing side walls 36, as shown in
In some embodiments, channel 38 may be disposed at alternate orientations, relative to axis A, 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 38 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. In some embodiments, the inner surface of wall 34 is concave between the concave interfaces between walls 34, 36. In some embodiments, the inner surface of wall 34 is continuously curved between the concave interfaces between walls 34, 36. In some embodiments, member 24 is made entirely of molded plastic.
Walls 36 each include a circular opening 46 extending perpendicular to axis A through inner and outer surfaces of walls 36 such that openings 46 are aligned and/or coaxial. Openings 46 are configured for disposal of a pin 48 that couples member 44 to member 24 such that member 44 can pivot relative to member 24 about a transverse axis B defined by openings 46 extending perpendicular to axis A, as will be discussed. In some embodiments, extension 32 comprises an opening 50 in a top surface 52 of extension 32 and an opening 54 in the inner surface of wall 34, as shown in
In some embodiments, openings 46, 50, 54 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. In some embodiments, openings 46 and/or axis B may be disposed at alternate orientations, relative to axis A, 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, member 44 can be variously connected with member 24, such as, for example, monolithic, integral connection, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element.
In some embodiments, body 26 includes a pair of conduits 58 each extending into an outer surface of extension 32 without extending through the inner surface of extension 32, as shown in
In some embodiments, cannula 22 comprises a plurality of light sources 68. In some embodiments, wires 66 each comprise an anode lead and a cathode lead. In some embodiments, light sources 68 are light emitting diodes (LEDs). In some embodiments, aperture 60, aperture 64 and/or opening 70 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. In some embodiments, wires 66 and/or light sources 68 have a thickness that is less than a depth of conduit 58 such that wires 66 and/or light sources 68 may be disposed entirely in conduit 58 without protruding therefrom. In some embodiments, wires 66 and/or light sources 68 are removable. In some embodiments, wires 66 and/or light sources 68 are fixed relative to member 24. In some embodiments, wires 66 and/or light sources 68 are embedded between inner and outer surfaces of body 26, such as, for example, inner and outer surfaces of wall 36 such that wires 66 and/or light sources 68 are embedded in a wall thickness of member 24. In some embodiments, light sources 68 can be variously connected with member 24, such as, for example, monolithic, integral connection, frictional engagement, threaded engagement, mutual grooves, screws, adhesive, nails, barbs and/or raised element.
Portion 30 includes a projection 74 defining a longitudinal axis C extending transverse to axis A. Projection 74 extends away from a top surface of body 26. Projection 74 comprises a flange 76 extending perpendicular to axis C. Flange 76 faces away from portion 28 and/or extension 32. In some embodiments, axis C extends at an acute angle relative to axis A. In some embodiments, axis C extends at an angle in a range of about 15 degrees to about 75 degrees relative to axis A. In some embodiments, axis C extends at an angle in a range of about 30 degrees to about 60 degrees relative to axis A. In some embodiments, axis C extends at an angle of about 45 degrees relative to axis A. In some embodiments, projection 74 is at least somewhat movable relative to body 26 such that projection can deflect at least slightly relative to body 26 without projection 74 breaking off from body 26. In some embodiments, projection 74 comprises a rigid material such that projection 74 cannot bend relative to body 26 without projection 74 breaking off from body 26.
As shown in
Body 26 comprises a protrusion 100 extending from wall 78 having an inner surface defining an unthreaded throughhole 105, as shown in
Compartment 88 includes a power source, such as, for example, a battery 94 removably positioned in compartment 88, as shown in
Wires 66 are coupled to battery 94 such that wires 66 can conduct power from battery 94 to light sources 68. In some embodiments, body 26 includes a circular opening 108 extending through wall 84, as shown in
Member 44 comprises a portion 112 and a portion 114, as shown in
In some embodiments, channel 126 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. In some embodiments, the inner surface of wall 122 is concave between the concave interfaces between walls 122, 124. In some embodiments, the inner surface of wall 122 is continuously curved between the concave interfaces between walls 122, 124. In some embodiments, member 44 is made entirely of molded plastic.
Walls 124 each include a circular opening 130 extending through inner and outer surfaces of walls 124 such that openings 130 are aligned and/or coaxial. Openings 130 are aligned and/or coaxial with openings 46 such that pin 48 extends through openings 46, 130. This configuration allows member 44 to pivot relative to member 24 about pin 48 with at least a portion of extension 32 disposed within extension 116. In some embodiments, extension 116 comprises an opening 132 in a top surface 134 of extension 116 and an opening 136 in the inner surface of wall 122, as shown in
Portion 114 comprises an inner surface defining a polygonal opening 140 having projection 74 extending therethrough, as shown in
Portion 114 is movable relative to projection 74 by pivoting member 44 relative to member 24 about axis B. This allows member 44 to pivot about the pivot point defined by pin 48 and/or axis B between a first configuration, shown in
In some embodiments, flange 76 engages an upper surface 142 of portion 114 when member 44 is in the second configuration and flange 76 engages a lower surface of portion 114 opposite surface 142 when member 44 is in the first configuration. The engagement of flange 76 with surface 142 and/or the lower surface of portion 114 locks member 44 in the first configuration or the second configuration. A force sufficient to move projection 74 relative to body 26 is required to move projection 74 relative to member 44 such that flange 76 disengages surface 142 or the lower surface of portion 114. Once flange 76 disengages surface 142 or the lower surface of portion 114, member 44 can be pivoted about pin 48 and/or axis B to move member 44 between the first and second configurations. In some embodiments, projection 74 is resilient such that projection 74 returns to its original position after the force is removed. In some embodiments, projection 74 is resiliently biased to engage flange 76 with surface 142 or the lower surface of portion 114.
In some embodiments, a distal end surface 144 of extension 32 is flush and/or aligned with a distal end surface 146 of extension 116 as member 44 moves between the first and second configurations, as shown in
In assembly, operation and use, surgical system 20, similar to that described above, is employed, for example, with a minimally invasive surgical procedure for spinal and neurosurgical applications with a patient. For example, during spine surgery, a surgeon will make an incision in the skin of a patient's back over vertebrae to be treated. One or more dilators may be employed to gradually separate the muscles and create a portal through which the surgery may be performed.
Cannula 22 is positioned adjacent the surgical site over the small incision. Cannula 22 is passed through the incision with member 44 in the first configuration. In some embodiments, cannula 22 is positioned over a dilator, such as, for example, the last dilator of a sequential dilator. Once cannula 22 is selectively positioned within the patient's anatomy, member 44 is moved from the first configuration, shown in
In some embodiments, at least one of light sources 68 are in an on position as member 44 moves from the first configuration to the second configuration. In some embodiments, at least one of light sources 68 are moved from an off position to an on position after member 44 is moved from the first configuration to the second configuration. When light sources 68 are in an on position, light sources 68 emit light into the working channel defined by inner surface of extensions 32, 116 to aid in visualization to perform a surgical procedure, for example. In some embodiments, light sources 68 are configured to emit light without creating shadows, making cannula 22 useful for imaging purposes, for example. Upon completion of the surgical procedure, cannula 22 is removed from the surgical site.
It is envisioned that the use of microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of cannula 22. It is contemplated that a surgical procedure may employ other instruments that can be mounted with cannula 22, such as, for example, nerve root retractors, tissue retractors, forceps, cutter, drills, scrapers, reamers, separators, rongeurs, taps, cauterization instruments, irrigation and/or aspiration instruments, illumination instruments and/or inserter instruments.
Cannula 22 may be employed for performing spinal surgeries, such as, for example, laminectomy, discectomy, fusion, laminotomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and procedures using bone graft and implantable prosthetics including plates, rods, and bone engaging fasteners.
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.