(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
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`(43) International Publication Date
`4 June 2015 (04.06.2015)
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`WIPOI PCT
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`\9
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`(10) International Publication Number
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`WO 2015/081142 A1
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`(51)
`
`International Patent Classification:
`A61F 2/44 (2006.01)
`A61F 2/46 (2006.01)
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`(21)
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`International Application Number:
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`PCT/U82014/067506
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`(22)
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`(25)
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`(26)
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`(30)
`
`(71)
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`(72)
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`(74)
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`(81)
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`International Filing Date:
`25 November 2014 (25.11.2014)
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`Filing Language:
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`Publication Language:
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`Priority Data:
`61/908,733
`26 November 2013 (26.11.2013)
`
`English
`
`English
`
`US
`
`Applicant: XENCO MEDICAL, LLC [US/US]; 9930
`Mesa Rim Road, San Diego, CA 92121 (US).
`
`Inventors: PRADO, Gustavo, R.; 9930 Mesa Rim Road,
`San Diego, CA 92121 (US) HAIDER, Jason; 9930 Mesa
`Rim Road, San Diego, CA 92121 (US).
`
`Agent: ZHONG, Jia; Wilson Sonsini Goodrich & Rosati,
`650 Page Mill Road, Palo Alto, CA 94304 (US).
`
`Designated States (unless otherwise indicated, for every
`kind ofnational protection available): AE, AG, AL, AM,
`
`A0, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
`BZ, CA, CII, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
`DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`IIN, IIR, IIU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
`MK, MN, MW, MX, MY, MZ, NA, NG, NI, No, NZ, OM,
`PA, PE, PG, PH, PL, PT, QA, Ro, RS, RU, RW, SA, SC,
`SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
`TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ,
`TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, KM, ML, MR, NE, SN, TD, TG).
`Published:
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`with international search report (Art. 21(3))
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`
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`(54) Title: LOCK AND RELEASE IMPLANT DELIVERY SYSTEM
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`Fig. 1b
`
`
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`(57) Abstract: Injection—molded devices and systems for graft or other tissue delivery, methods for their single—use in delivery of an
`implant, and kits for their sterile delivery to a practitioner are disclosed herein. Systems for implant delivery comprise an injection
`moldable implant body and an insertion device comprising: an inner and outer shaft that form a locking mechanism that secures an
`implant body in place and releases it upon placement within a patient. Systems are configured to be manufactured by injection mold -
`ing, such that they can be cost—effectively manufactured and discarded after a single use to avoid costs and risks associated with re—
`sterilization and cleaning, but can in some cases optionally also be manufactured by machining to be re-sterilized and reused.
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`

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`WO 2015/081142
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`PCT/U82014/067506
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`LOCK AND RELEASE IMPLANT DELIVERY SYSTEM
`
`CROSS-REFERENCE
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`[001] This application claims priority to United States Provisional Patent Application Serial
`
`Number 61/908,733, filed November 26, 2013, which is explicitly incorporated herein by reference
`
`in its entirety.
`
`BACKGROUND OF THE INVENTION
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`[002] Traditionally, implant insertion device and spinal implant are machined individually to
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`accommodate the need of different patient and different surgical procedures.
`
`SUMMARY OF THE INVENTION
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`[003] Machinable implant insertion devices and implants can be individually tailored to the needs
`
`of the patient, practitioner and/or the medical procedure. However, the cost of machining each
`
`implant insertion device and implant with different materials and sizes is significantly higher than
`
`molding an injection moldable equivalent. The cost of these reusable devices and implants is
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`manifest in their manufacture but also in the expense of professional device cleaning, autoclaving,
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`sterilization, transport, and maintenance. The risk of contamination rises with the complex
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`procedure for cleaning and transporting the devices and implants between usages. There are also
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`costs and risks associated with dealing with infections caused by failure to clean and sterilize.
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`[004]
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`Injection moldable implant insertion devices and implant bodies can be molded using one or
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`more durable materials at a lower price than their machinable equivalents. In addition, the injection
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`moldable implant insertion devices and implant bodies are easily made and can be deployed for
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`single use only, so that the contamination associated with the cleaning, autoclaving, sterilization,
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`transp ortation, or maintenance of the machined equivalents are significantly reduced or completely
`
`eliminated. Thus, the cost of the implant insertion device and implant body per usage is
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`significantly lower than the re-usable machined equivalent, even if the devices are discarded after a
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`single use. Further, injection moldable implant insertion devices and implants can be packed in
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`sterile and peelably sealed kits to prevent contamination and facilitate surgical needs in different
`
`medical procedures.
`
`[005]
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`In some aspects, disclosed herein are implant delivery systems comprising: an implant
`
`body comprising a support structure and an internal space, the support structure comprising: an
`
`outer surface; a main slot indented into the outer surface; a chamber indented from the main slot,
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`the chamber being deeper than the main slot; two side slots at the outer surface proximal to the
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`main slot; wherein the implant body is substantially toroidal, the internal space is not covered at a
`
`top cross section and a bottom cross section thereof by the support structure, and the internal space
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`is configured to receive at least one graft material therewithin; and an implant insertion device
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`comprising: an inner shaft comprising: an inner shaft body; a knob at a base of the inner shaft
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`body, the knob comprising a cam feature; an inner shaft tip at an insertion end of the inner shaft
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`body, wherein the inner shaft tip is not substantially cylindrically circular and the inner shaft tip is
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`wider than the inner shaft body immediately adjacent thereto in at least one dimension
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`perpendicular to a plane of rotation of the inner shaft tip; an outer shaft configured to hold the inner
`
`shaft body therein, the outer shaft comprising: a hollow outer shaft body, wherein the outer shaft
`
`body is configured to accommodate the inner shaft body therewithin; an outer face; an outer shaft
`
`opening at the outer face of the outer shaft, the outer shaft opening being configured to allow
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`passage of the inner shaft tip; two outer shaft tips at the outer face to fit the two side slots of the
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`implant body; a first sulface at a base of the outer shaft configured to receive the cam feature of the
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`knob at a first position; a second surface at the base of the outer shaft configured to receive the cam
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`feature of the knob at a second position; a stopper at the base of the outer shaft configured to stop
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`the cam feature at the first or the second position; a ramp at the base of the outer shaft, wherein the
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`ramp connects the first surface to the second surface, wherein the inner shaft is configured to rotate
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`within the outer shaft such that the cam feature moves to the first position or the second position at
`
`the base of the outer shaft, wherein the rotation of the inner shaft is configured to transform into a
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`linear movement of the inner shaft along a direction perpendicular to a plane of the rotation of the
`
`inner shaft tip, wherein the inner shaft tip is configured to fit through the main slot of the implant
`
`body and rotate in the chamber of the implant body so as to lock or unlock the implant body to the
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`inner shaft, and the two side slots of the implant body are configured to fit the two outer shaft tips
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`at the outer face of the outer shaft so as to attach the implant body to the outer shaft, and wherein
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`the inner shaft is unlocked from the outer shaft at the first position and the inner shaft is locked to
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`the outer shaft at the second position.
`
`[006]
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`In some aspects, disclosed herein are implant delivery systems comprising: an implant
`
`insertion device comprising: an inner shaft comprising: an inner shaft body; a knob at a base of the
`
`inner shaft body, the knob comprising a first interface; an inner shaft tip at an insertion end of the
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`inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular; an outer shaft
`
`configured to hold the inner shaft body therein, the outer shaft comprising: a hollow outer shaft
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`body, wherein the outer shaft body is configured to accommodate the inner shaft body therewithin;
`
`an outer face; an outer shaft opening at the outer face of the outer shaft; a first complementary
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`interface at a base of the outer shaft configured to receive the first interface of the inner shaft; a
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`second complementary interface at the outer face to receive a second interface of the implant body;
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`wherein a rotation of the inner shaft is configured to associate the first complementary interface to
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`the first interface at a first position or at a second position, wherein the inner shaft tip is configured
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`to fit through a main slot of an implant body and rotate in a chamber of the implant body so as to
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`lock the implant body to the inner shaft.
`
`[007]
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`In some cases, disclosed herein are implant delivery systems comprising: an implant
`
`insertion device comprising: an inner shaft comprising: an inner shaft body; a knob at a base of the
`
`inner shaft body, the knob comprising a first interface; an inner shaft tip at an insertion end of the
`
`inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular; an outer shaft
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`configured to hold the inner shaft body therein, the outer shaft comprising: a hollow outer shaft
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`body, wherein the outer shaft body is configured to accommodate the inner shaft body therewithin;
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`an outer face; an outer shaft opening at the outer face of the outer shaft; a first complementary
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`interface at a base of the outer shaft configured to receive the first interface of the knob; a second
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`complementary interface at the outer face; an implant body comprising a support structure and an
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`internal space, the support structure comprising: an outer surface; a main slot indented into the
`
`outer surface; a chamber indented from the main slot and deeper than the main slot; a second
`
`interface at the outer surface proximal to the main slot to fit the second complimentary interface at
`
`the outer face; wherein the implant body is substantially toroidal, the internal space is not covered
`
`at a top cross section, a bottom cross section, or the top and the bottom cross sections thereof by the
`
`support structure, and the internal space is configured to receive at least one graft material, wherein
`
`a rotation of the inner shaft is configured to associate the first complementary interface to the first
`
`interface at a first position or a second position, wherein the inner shaft tip is configured to fit
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`through a main slot of an implant body and rotate in a chamber of the implant body so as to lock the
`
`implant body to the inner shaft.
`
`[008]
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`In some aspects, disclosed herein are methods for delivering an implant body using an
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`implant insertion device comprising:
`
`locking the implant body to the implant insertion device by
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`rotating a knob of an inner shaft of the implant insertion device in a manner such that the rotation of
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`the knob: rotates an inner shaft tip within a chamber of the implant body such that a major axis of a
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`main slot and a major axis of the inner shaft tip are not substantially parallel, linearly moves the
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`implant body towards an insertion end of an outer shaft of the implant insertion device so as to
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`secure the implant body against the insertion end of the outer shaft, delivering the implant body into
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`a subject using the implanting insertion device; reversely rotating the knob of the inner shaft of the
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`implant insertion device in a manner such that the reverse rotation of the knob rotates the inner
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`shaft tip Within the main slot in the implant body such that the major axis of the main slot and the
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`major axis of the inner shaft tip are substantially parallel, associates the first interface of the knob to
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`the first complimentary interface at the outer shaft at a second position. In some aspects the
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`methods comprise inserting the implant into an intervertebral space. In some aspects the
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`intervertebral space is lumbar. In some aspects the intervertebral space is cervical. In some aspects
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`intervertebral disk material is removed from the intervertebral space prior to inserting the implant.
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`In some aspects the implant is inserted into the interior of an intervertebral disk.
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`[009]
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`In some cases, disclosed herein are methods for delivering an implant body using an implant
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`insertion device comprising releasing an implant body into an intervertebral space of a patient
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`comprising: rotating a knob of an inner shaft of the implant insertion device in a manner such that
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`a rotation of the knob rotates an inner shaft tip Within a main slot in the implant body substantially
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`in a coronal plane such that a major axis of the main slot and a major axis of the inner shaft tip are
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`substantially parallel, and associates a first interface of the knob to a first complimentary interface
`
`at an outer shaft at a unlocked position; and depositing the implant body in an intervertebral space
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`of the patient. In some aspects the methods comprise inserting the implant into an intervertebral
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`space. In some aspects the intervertebral space is lumbar. In some aspects the intervertebral space
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`is cervical. In some aspects intervertebral disk material is removed from the intervertebral space
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`prior to inserting the implant. In some aspects the implant is inserted into the interior of an
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`intervertebral disk.
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`[010]
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`In some aspects, disclosed herein are sterile kits containing a single—use implant body
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`insertion device and a single use implant, the sterile kit comprising: a sterile kit cover sealed to
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`enclose at least one device tray, at least one implant body, and at least one implant insertion device
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`therewithin, wherein the at least one implant body and the at least one implant insertion device are
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`configured for a single usage; the at least one device tray is configured to secure:
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`the at least one
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`implant insertion device; the at least one implant body; the at least one implant insertion device
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`comprising: a shaft; a tip; a first interface for locking the at least one implant body; a second
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`interface for locking the at least one implant body; a first position; a second position; and the at
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`least one implant body comprising: an internal space; a slot for locking the at least one implant
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`body against the at least one implant insertion device at the first position; a first complimentary
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`interface for receiving the interface of the at least one implant insertion device at the first position
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`or the second position; a second complimentary interface for receiving the second interface of the at
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`least one implant insertion device at the first position. In some aspects, sterile kits may also contain
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`pre—assembled grafting material within the graft window of implant. Grafting material may be
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`packed allograft bone (demineralized or not), packed biocompatible ceramics granules (beta-
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`tricalciurn phosphate, hydroxyapatite, calcium sulfate, and equivalents) to assume the graft volume
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`shape, biocompatible ceramic granules held by biocompatible matrix such as collagen with or
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`without bioglass and with or without hyaluronic acid.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[011] Fig. 1a shows an embodiment of the implant insertion device and the implant body attached
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`to the implant insertion device.
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`[012] Fig. 1b shows an embodiment of the implant insertion device.
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`[013] Fig. 2 shows an embodiment of the implant insertion device.
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`[014] Fig. 3 shows an embodiment of the implant body.
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`[015] Fig. 4 shows an embodiment of the implant body.
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`[016] Fig. 5 shows a 3-part mold that is used to mold the embodiment shown in Fig. 3
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`[017] Fig. 6 shows an embodiment of the implant body.
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`[018] Fig. 7 shows the embodiment of the inner shaft and outer shaft of the implant insertion
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`device in Fig. 2.
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`[019] Fig. 8 shows an embodiment of the inner shaft tip.
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`[020] Fig. 9 shows an embodiment of the base of the outer shaft.
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`[021] Fig. 10 shows an embodiment of the locking interface of the inner shaft and the outer shaft.
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`[022] Fig. 11 shows an embodiment of preventing the inner shaft from being accidentally
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`removed from the outer shaft.
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`[023] Fig. 12 shows an embodiment of the implant insertion device.
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`[024] Fig. 13 shows molds to make the implant insertion device of Fig. 12.
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`[025] Fig. 14 shows an embodiment of the knob of the inner shaft and the base of the outer shaft.
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`[026] Fig. 15 shows an embodiment of the knob of the inner shaft.
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`[027] Fig. 16 shows an embodiment of the rotation of the inner shaft and linear movement of the
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`inner shaft with respect to the outer shaft so as to lock the implant body to the implant insertion
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`device.
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`DETAILED DESCRIPTION OF THE INVENTION
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`[028] Chronic spinal pain is a common issue among a large number of people worldwide, and is a
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`major health and quality of life concern. Back pain can impair onc’s ability to work, concentrate
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`and exercise, thus having a substantial effect on one’s quality of life. Spinal pain, either in the neck
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`or back, is often associated with damage to one or more intervertebral discs. A herniated disc may
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`exude its soft, internal protective material (nucleus pulposus) outside of the disc area. When this
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`exuded material presses on the nerves that run down the spine, the result can be a loss of range of
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`motion, sharp localized pain, and/or dull radiating pain to one or more extremities. Secondary
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`effects of spinal pain can include depression, loss of work efficiency, and early cognitive
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`degeneration.
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`[029] One effective approach to addressing spinal pain is fusion of the adjacent vertebrae. Fusion
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`of adjacent vertebrae can be accomplished by introduction of graft tissue between the vertebrae,
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`such as into the herniated disc or into a space created by removal of the herniated disc. Graft tissue,
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`as used herein, may comprise autologous patient tissue, such as bone tissue taken from elsewhere in
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`the patient during the procedure. Graft tissue may be cadaverous, or cultured or synthetically
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`produced from differentiated or undifferentiated cell populations derived from the patient or
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`elsewhere. Graft tissue, if properly inserted and protected, can lead to filsion of the adjacent
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`vertebrae.
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`[030] Stabilizing graft tissue is a major challenge. The spinal column, particularly the lumbar
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`spine and the cervical spine, must sustain substantial pressures, and these pressures can easily
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`disrupt an unstabilized graft. The graft material must be delivered into the intervertebral space with
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`a minimum of damage to the surrounding tissue.
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`[031]
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`In addition, contamination or infection of the graft material or the insertion site during the
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`procedure is a major risk. Current methods and devices for insertion of graft material involve
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`reusable, machined materials that must be sterilized between uses. Although this process allows re-
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`use of the devices, the sterilization process is costly and not without risk, as unsuccessfully
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`sterilized or unclean materials can lead to major complications.
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`[032]
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`Injection-molded devices can be made out of materials that are substantially less costly to
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`produce, without loss in single—use material durability. These injection molded devices can be
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`sterilely manufactured and packaged, so that they can be delivered to an operating room without
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`risk of contamination. Once used, they are disposed of rather than being cleaned and sterilized. This
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`single-use aspect has both medical and economic benefits:
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`the risk of infection is greatly reduced
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`relative to the risk associated with multi—use devices; and the cost of manufacturing inj ection-
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`molded devices is substantially lower than the cost of sterilizing devices for re—use.
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`[033] Accordingly, the single—use, injection moldable devices and methods disclosed herein are
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`able to increase patient health, reduce risk of infection and reduce health costs.
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`[034] Disclosed herein, in certain embodiments, are implant delivery systems comprising: an
`
`implant body comprising a support structure and an internal space, the support structure
`
`comprising: an outer surface; a main slot indented into the outer surface; a chamber indented from
`
`the main slot, the chamber being deeper than the main slot; two side slots at the outer surface
`
`proximal to the main slot; wherein the implant body is substantially toroidal, the internal space is
`
`not covered at a top cross section and a bottom cross section thereof by the support structure, and
`
`the internal space is configured to receive at least one graft material therewithin; and an implant
`
`insertion device comprising: an inner shaft comprising: an inner shaft body; a knob at a base of the
`
`inner shaft body, the knob comprising a cam feature; an inner shaft tip at an insertion end of the
`
`inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular and the inner
`
`shaft tip is wider than the inner shaft body immediately adjacent thereto in at least one dimension
`
`perpendicular to a plane of rotation of the inner shaft tip; an outer shaft configured to hold the inner
`
`shaft body therein, the outer shaft comprising: a hollow outer shaft body, wherein the outer shaft
`
`body is configured to accommodate the inner shaft body therewithin; an outer face; an outer shaft
`
`opening at the outer face of the outer shaft, the outer shaft opening being configured to allow
`
`passage of the inner shaft tip; two outer shaft tips at the outer face to fit the two side slots of the
`
`implant body; a first surface at a base of the outer shaft configured to receive the cam feature of the
`
`knob at a first position; a second surface at the base of the outer shaft configured to receive the cam
`
`feature of the knob at a second position; a stopper at the base of the outer shaft configured to stop
`
`the cam feature at the first or the second position; a ramp at the base of the outer shaft, wherein the
`
`ramp connects the first surface to the second surface, wherein the inner shaft is configured to rotate
`
`within the outer shaft such that the cam feature moves to the first position or the second position at
`
`the base of the outer shaft, wherein the rotation of the inner shaft is configured to transform into a
`
`linear movement of the inner shaft along a direction perpendicular to a plane of the rotation of the
`
`inner shaft tip, wherein the inner shaft tip is configured to fit through the main slot of the implant
`
`body and rotate in the chamber of the implant body so as to lock or unlock the implant body to the
`
`inner shaft, and the two side slots of the implant body are configured to fit the two outer shaft tips
`
`at the outer face of the outer shaft so as to attach the implant body to the outer shaft, and wherein
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`the inner shaft is unlocked from the outer shaft at the first position and the inner shaft is locked to
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`the outer shaft at the second position.
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`[035] Also disclosed herein, in certain embodiments, are implant delivery systems comprising: an
`
`implant insertion device comprising: an inner shaft comprising: an inner shaft body; a knob at a
`
`base of the inner shaft body, the knob comprising a first interface; an inner shaft tip at an insertion
`
`end of the inner shaft body, wherein the inner shaft tip is not substantially cylindrically circular; an
`
`outer shaft configured to hold the inner shaft body therein, the outer shaft comprising: a hollow
`
`outer shaft body, wherein the outer shaft body is configured to accommodate the inner shaft body
`
`therewithin; an outer face; an outer shaft opening at the outer face of the outer shaft; a first
`
`complementary interface at a base of the outer shaft configured to receive the first interface of the
`
`inner shaft; a second complementary interface at the outer face to receive a second interface of the
`
`implant body; wherein a rotation of the inner shaft is configured to associate the first
`
`complementary interface to the first interface at a first position or at a second position, wherein the
`
`inner shaft tip is configured to fit through a main slot of an implant body and rotate in a chamber of
`
`the implant body so as to lock the implant body to the inner shaft. In some cases, the implant
`
`delivery system comprises an implant body comprising a support structure and an internal space,
`
`the support structure comprising: an outer surface; a main slot indented into the outer surface; a
`
`chamber indented from the main slot, the chamber being deeper than the main slot; the second
`
`interface at the outer surface proximal to the main slot; wherein the implant body is substantially
`
`toroidal, and the internal space is not covered at a top cross section, a bottom cross section, or the
`
`top and bottom cross sections thereof by the support structure, and the internal space is configured
`
`to receive at least one graft material; and an internal space configured to contain at least a graft
`
`material. In some cases, the second interface of the implant body is configured to fit the second
`
`complementary interface at the outer face of the outer shaft so as to attach the implant body to the
`
`outer shaft. In some cases, the implant insertion device is disposable. In some cases, the implant
`
`insertion device is for one—time use only. In some cases, the implant insertion device is injection
`
`moldable. In some cases, the implant delivery system is disposable. In some cases, the implant
`
`delively system is for one-time use only. In some cases, the second interface comprises at least one
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`side slot indented into the implant body proximal to the main slot, wherein each side slot is
`
`configured to receive an outer shaft tip. In some cases, the at least one side slot is peripherally
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`proximal to the main slot. In some cases, the at least one side slot is shallower than the main slot. In
`
`some cases, the main slot and the at least one side slot are indented into the supporting structure. In
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`some cases, wherein the main slot is indented deeper into the wall of the implant body than the two
`
`side slots along the insertion direction. In some cases, the internal space of the implant body is
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`filled at least partly by at least one graft material. In some cases, the implant body is substantially
`
`toroidal. In some cases, wherein a toroidal shape is a shape with a plurality of cross sections
`
`stacked together continuously, each cross section having an arbitrary two dimensional empty area
`
`enclosed by a wall. In some cases, the height of the implant body is non-uniform along the anterior—
`
`to—postcrior direction so as to accommodate the lordosis angle of the spinal cord when the implant
`
`body is properly inserted. In some cases, a toroidal shape is a shape comprising a hole throughout
`
`an arbitrary three dimensional volume. In some cases, the internal space is not covered at the top
`
`cross section, bottom cross section, or top and bottom cross sections thereof by the implant body. In
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`some cases, the implant body enclosing the internal space has a wall thickness of at least 1
`
`millimeter but no more than 3 centimeters. In some cases, the implant body comprises at least one
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`selected from polyether ether ketone (PEEK), carbon fiber-reinforced polymer, carbon fiber-
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`reinforced plastic, carbon fiber—reinforced thermoplastic, glass fiber—reinforced polymer, glass fiber—
`
`reinforced plastic, and polyaryletherketone (PEAK). In some cases, the implant body is injection
`
`moldable. In some cases, the implant body is machinable. In some cases, the implant body
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`comprises a saw tooth configured to allow unidirectional insertion into a subject on an outer surface
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`of the implant body. In some cases, the saw tooth is further located on the longitudinal plane of the
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`implant body. In some cases, the saw tooth is configured to prevent sliding back—out of an implant
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`body after an insertion. In some cases, the implant body comprises at least one space for
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`accommodating at least one detectable tag. In some cases, the at least one detectable tag comprise a
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`radio frequency detectable tag. In some cases, the at least one space are in the wall of the implant
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`body. In some cases, the implant body comprises two spaces for detectable tags, the two spaces
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`being not greater than 5 mm in their widest dimension. In some cases, the implant body comprises
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`two spaces for detectable tags, the two spaces being spatially separated from each other. In some
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`cases, the implant body comprises four spaces for detectable tags, the four spaces being spatially
`
`separated from each other. In some cases, the cross section of the implant body along a longitudinal
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`plane comprises a closed contour formed by the implant body. In some cases, wherein the closed
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`contour encloses an area therewithin. In some cases, the internal space is enclosed by closed
`
`contours in a plurality of adjacent longitudinal planes. In some cases, the cross section of the
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`implant body along a longitudinal plane is a square, a rectangle, a circle, an ellipse, a rhombus, a
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`trapezoid, a pentagon, or an arbitraly two dimensional shape enclosing an empty two dimensional
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`area in a closed contour by a wall. In some cases, the cross section of the implant body along a
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`longitudinal plane is a two—dimensional shape similar to a cross section of the intervertebral space
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`to be inserted therein. In some cases, the cross section of the implant body along a longitudinal
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`plane is comprises a closed contour with a non-uniform thickness along the closed contour. In some
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`9
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`WO 2015/081142
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`PCT/U82014/067506
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`cases, the non-uniform thickness along the closed contour is filled with at least one selected from
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`polyether ether ketone (PEEK), carbon fiber-reinforced polymer, carbon fiber-reinforced plastic,
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`carbon fiber-reinforced thermoplastic, glass fiber-reinforced polymer, glass fiber-reinforced plastic,
`
`and polyaryletherketone (PEAK).In some cases, the chamber of the implant body is connected to a
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`slot indented from a top-most region or a bottom-most region of the outer surface along the
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`longitudinal direction. In some cases, wherein the slot at the top-most region or the bottom-most
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`region of the support structure is configured to facilitate injection molding of the chamber. In some
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`cases, the slot at the top-most region or the bottom-most of the support structure is configured to
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`enable Visualization of the inner shaft tip. In some cases, the inner shaft is disposable. In some
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`cases, the inner shaft is for one-time use only. In some cases, the inner shaft comprises at least one
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`selected from carbon fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon fiber—
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`reinforced thermoplastic, glass fiber—reinforced polymer, glass fiber—reinforced plastic, and
`
`polyarylamide. In some cases, the inner shaft comprises about 50% glass. In some cases, the inner
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`shaft comprises a glass content of at least 10% to no greater than 70%. In some cases, the inner
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`shaft tip comprises at least one metal. In some cases, the inner shaft body comprises at least one
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`metal. In some cases, the inner shaft is injection moldable. In some cases, the inner shaft tip is
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`injection moldable. In some cases, the inner shaft body is injection moldable. In some cases, the
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`knob is injection moldable. In some cases, the inner shaft is injection moldable and machinable. In
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`some cases, the inner shaft body is substantially cylindrical. In some cases, the inner shaft body is
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`flexible so as to fit in a curved outer shaft body. In some cases, the inner shaft body is a cylinder. In
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`some cases, the knob of the inner shaft is not enclosed in the outer shaft. In some cases, the inner
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`shaft tip is not enclosed in the outer shaft. In some cases, the inner shaft tip is connected to the
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`inner shaft body in