Certain spinal fusion procedures remove degenerated intervertebral disc material and pack the intervertebral space to maintain the separation between adjacent vertebrae. While some procedures pack the intervertebral space with bone-forming tissue, other procedures insert rigid devices for more reliable separation of the vertebrae. In the interest of reducing recovery time and surgical tissue damage, it is advantageous for a rigid device insert to possess a small profile to fit through a minimally invasive incision and to steer around corners, while also possessing a large footprint to maximize stability in the intervertebral disc space.
Thus, there is a need in the art for small profile rigid devices that are able to navigate corners and expand to occupy a larger footprint. The present invention satisfies this need.
In one aspect, the present invention relates to an articulating expandable device, comprising: a first and a second superior arm and a first and a second inferior arm; the first superior arm further comprising a hinged connector extending from its posterior end; and the second superior arm further comprising a socket extending from its posterior end.
In one embodiment, each arm possesses an anterior and a posterior end and a top and a bottom surface, and each arm having an anterior and posterior opening through the top and bottom surface, wherein the first superior arm is positioned over the first inferior arm with anterior and posterior openings in alignment, and the second superior arm is positioned over the second inferior arm with anterior and posterior openings in alignment.
In one embodiment, the device further comprises: four cylindrical bolts positioned within each of the openings of the arms; a first rod connecting each of the bolts positioned within the anterior openings of the arms; and a second rod connecting each of the bolts positioned within the posterior openings of the arms.
In one embodiment, the cylindrical bolts further comprise: a top end, a bottom end, an outer surface, and at least one upper curved slot and at least one lower curved slot extending through each bolt, wherein each curved slot has a closed position near a center of each bolt, each of the at least one upper curved slot has an open position near the top end of each bolt, and each of the at least one lower curved slot has an open position near the bottom end of each bolt.
In one embodiment, the device further comprises a plurality of pins, each pin connected to an inner surface of each of the openings of the arms and slidably engaged to a curved slot of the bolt positioned within the respective opening.
In one embodiment, each of the four arms are substantially parallel to each other in a closed configuration. In one embodiment, the four arms are movable about the four bolts while maintaining substantially parallel alignment to each other.
In one embodiment, the device comprises a closed configuration that positions the four arms adjacent to each other and positions the plurality of pins near the center of each bolt. In one embodiment, the device comprises an open configuration that positions the four arms away from each other and positions the plurality of pins near the top and bottom ends of each bolt. In one embodiment, at least one arm comprises a locking bit drivable into a bolt.
In one aspect, the present invention relates to an insertion tool, comprising: a posterior handle having a rotating section, a nonrotating section, and a lumen running throughout; an expandable pair of tongs extending from the nonrotating section in an anterior direction, the tongs having a hinged anterior connector; a locking sleeve slidable over the pair of tongs; and an elongate deployment driver positioned within the lumen of the housing, the deployment driver having a hingedly connected driver horn.
In one embodiment, anterior and posterior movement of the locking sleeve is lockable using a backstop. In one embodiment, actuating the rotating section of the housing moves the deployment driver in an anterior or posterior direction. In one embodiment, the locking sleeve comprises a wedge positioned between each member of the pair of tongs, such that posterior sliding of the locking sleeve expands the pair of tongs.
In one aspect, the present invention relates to an articulating expandable device kit, comprising: an articulating expandable device comprising: a first and a second superior arm and a first and a second inferior arm, each arm having an anterior and a posterior end and a top and a bottom surface, and each arm having an anterior and posterior opening through the top and bottom surface, wherein the first superior arm is positioned over the first inferior arm with anterior and posterior openings in alignment, and the second superior arm is positioned over the second inferior arm with anterior and posterior openings in alignment; four cylindrical bolts positioned within each of the openings of the arms, each bolt having a top end, a bottom end, an outer surface, and at least one upper curved slot and at least one lower curved slot extending through each bolt, wherein each curved slot has a closed position near a center of each bolt, each of the at least one upper curved slot has an open position near the top end of each bolt, and each of the at least one lower curved slot has an open position near the bottom end of each bolt; a first rod connecting each of the bolts positioned within the anterior openings of the arms, and a second rod connecting each of the bolts positioned within the posterior openings of the arms; and a plurality of pins, each pin connected to an inner surface of each of the openings of the arms and slidably engaged to a curved slot of the bolt positioned within the respective opening; wherein the first superior arm comprises a hinged connector extending from its posterior end, and the second superior arm comprises a socket extending from its posterior end; and an insertion tool comprising: a posterior handle having a rotating section, a nonrotating section, and a lumen running throughout; an expandable pair of tongs extending from the nonrotating section in an anterior direction, the tongs having a hinged anterior connector engageable to the hinged connector of the articulating expandable device; a locking sleeve slidable over the pair of tongs; and an elongate deployment driver positioned within the lumen of the housing, the deployment driver having a hingedly connected driver horn engageable to the socket of the articulating expandable device.
In one embodiment, the articulating expandable device is configured to removably attach to the insertion tool in a closed configuration by hingedly engaging the connector to the tongs and the socket to the driver horn. In one embodiment, actuating the rotating section of the housing moves the deployment driver in an anterior direction and articulates the articulating expandable device about the hinged engagement between the connector and the tongs.
In one embodiment, the articulating expandable device is articulated by an angle between a longitudinal axis of the articulating expandable device and a longitudinal axis of the insertion device. In one embodiment, the angle is between about 1 degrees and 180 degrees. In one embodiment, the angle is between about 181 degrees and 360 degrees.
In one embodiment, the articulation of the articulating expandable device is limited by a physical stop. In one embodiment, further actuation of the rotating section of the housing moves the deployment driver in an anterior direction and expands the articulating expandable device to an open configuration. In one embodiment, the locking sleeve comprises a lumen having a locking bit driver configured to drive a locking bit into the articulating expandable device, such that the articulating expandable device is locked in the open configuration.
In one embodiment, the open configuration of the articulating expandable device is any configuration other than a closed configuration. In one embodiment, the locking sleeve comprises a wedge positioned between each member of the pair of tongs, such that posterior sliding of the locking sleeve expands the pair of tongs and releases the articulating expandable device from the insertion device.
In one embodiment, a deployment instrument includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, wherein at least one of the stabilization retainer and deployment driver is translatable along the central axis. In one embodiment, only the deployment driver is translatable along the central axis. In one embodiment, the deployment driver is slidably translatable along the central axis. In one embodiment, the proximal handle includes one or more features selected from the group consisting of (i) an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism selected from the group consisting of sliding rail, ratchet, worm gear, screw, cam and follower, lever, gear, spring, and combinations thereof; (ii) a slap hammer surface; and (iii) combinations thereof. In one embodiment, the proximal handle includes an actuator that drives translation of the deployment driver along the central axis, the actuator comprising corresponding threaded engagement between a proximal portion of the deployment driver and a housing portion of the proximal handle, wherein the threaded engagement can drive movement of the deployment driver along the central axis. In one embodiment, the proximal handle includes a lock that prevents actuation of translation of the deployment driver along the central axis. In one embodiment, one or both of the stabilization retainer and the pivot arm of the deployment is forked at its distal end the forks including opposing pins that form a hinged connector with a pivot axis. In one embodiment, only the stabilization retainer is forked at its distal end, the fork including opposing pins that form a hinged connector with a pivot axis. In one embodiment, the stabilization retainer includes at its distal end a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector. In one embodiment, the stabilization retainer includes at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the opposing pair of retaining pins forming a hinged connector. In one embodiment, the device includes a locking sleeve that is slidable along the central axis over the stabilization retainer to releasably compress the opposing fork arms. In one embodiment, the locking sleeve comprises a wedge that is positionable between the opposing fork arms, such that when the wedge is positioned most distally relative to the fork arms, the fork arms are in a relaxed orientation, and when the wedge is moved proximally by translation of the sleeve proximally along the stabilization retainer, the wedge contacts the opposing fork arms into an expanded orientation and the opposing retaining pins are displaced away from each other. In one embodiment, the proximal handle includes a lock that retains the locking sleeve in place to compress the opposing fork arms. In one embodiment, the hingedly connected pivot arm on the deployment driver includes a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector, wherein each of the retaining pins projects outward from the pivot arm. In one embodiment, the hingedly connected pivot arm on the deployment driver includes at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the pair of opposing retaining pins forming a hinged connector.
In one embodiment, a deployment instrument, includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, the stabilization retainer including at its distal end a first pair of retaining pins oriented along an axis that is transverse to the central axis, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, the pivot arm including at a distal end a second pair of retaining pins, wherein at least one of the stabilization retainer and deployment driver is slidably translatable along the central axis.
In one embodiment, a deployment instrument includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, the stabilization retainer including at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the opposing pair of retaining pins forming a hinged connector, a locking sleeve that is slidable along the central axis over the stabilization retainer to releasably compress the opposing fork arms, the locking sleeve comprising a wedge that is positionable between the opposing fork arms, such that when the wedge is positioned most distally relative to the fork arms, the fork arms are in a relaxed orientation, and when the wedge is moved proximally by translation of the sleeve proximally along the stabilization retainer, the wedge contacts the opposing fork arms into an expanded orientation and the opposing retaining pins are displaced away from each other, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, the pivot arm including at its distal end a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector, wherein each of the retaining pins projects outward from the pivot arm, wherein the handle includes an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism the proximal handle includes one or more features selected from the group consisting of (i) an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism selected from the group consisting of sliding rail, ratchet, worm gear, screw, cam and follower, lever, gear, spring, and combinations thereof; (ii) a slap hammer surface; and (iii) combinations thereof.
In one embodiment, an articulating expandable device kit includes an articulating expandable device having a first and a second superior arm and a first and a second inferior arm, the first superior arm further comprising a hinged connector extending from its posterior end, and the second superior arm further comprising a socket extending from its posterior end; and a deployment instrument having a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, wherein at least one of the stabilization retainer and deployment driver is translatable along the central axis. In one embodiment, the articulating expandable device is configured to removably attach to the deployment instrument in a closed configuration by hingedly engaging the connector to the stabilization retainer and engaging the socket to the pivot arm of the deployment driver wherein the articulating expandable device includes positive stop features that retain the articulating expandable device in the closed configuration that is aligned with the central axis of the deployment instrument, and wherein actuating translation of the deployment driver along the central axis to drive the pivot arm distally, the pivot arm is driven to rotate driving the engaged socket to translate the articulating expandable device into an open configuration and oriented substantially transverse to the central axis.
In one embodiment, a method for deployment of an articulating an expandable device into a space between adjacent vertebral bodies includes the steps of providing the expandable device comprising a first and a second superior arm and a first and a second inferior arm, the first superior arm further comprising a hinged connector extending from its posterior end, and the second superior arm further comprising a socket extending from its posterior end; removably affixing the articulating expandable device to the deployment instrument in a closed configuration by hingedly engaging the connector to the stabilization retainer and engaging the socket to the pivot arm of the deployment driver; retaining the articulating expandable device in the closed configuration that is aligned with the central axis of the deployment instrument while passing the device as retained on the deployment instrument into a space between two adjacent vertebral bodies at a first orientation that is oblique to an anterior to posterior axis of the adjacent vertebral bodies; actuating the deployment driver of the deployment instrument along the instrument's central axis to rotate the articulating expandable device into an open configuration and oriented substantially transverse to the central axis to direct the device in a second orientation that is generally oriented transverse to the anterior to posterior axis of the adjacent vertebral bodies; passing an expansion driver adjacent the deployment instrument and into engagement articulating expandable device to expand the articulating expandable device in a cephaloncaudal dimension and into compressive contact with the vertebral bodies; and actuating the locking bit of the articulating expandable device to fix the device into a locked configuration. In one embodiment, the method includes initially driving the articulating expandable device into the surgical site by hammering on a slap hammer surface at the proximal handle of the deployment instrument. In one embodiment, the method includes actuating release of the stabilization retainer from the articulating expandable device. In one embodiment, the method includes expanding the articulating expandable device results in the release of the pivot arm of the deployment driver.
The following detailed description of exemplary embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.
The present invention provides articulating expandable devices and insertion tools for deploying the articulating expandable devices. The articulating expandable devices are capable of being inserted into narrow spaces and turning around corners. The articulating expandable devices are capable of increasing in height and width when expanded from a closed configuration to an open configuration to occupy a larger volume and to present a larger surface area. The articulating expandable devices are lockable and are capable of rigidly occupying a space after expansion. In some embodiments, the articulating expandable devices are useful as interbody devices for spinal fusions.
It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements typically found in the art. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.
Unless defined elsewhere, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the exemplary methods and materials are described.
As used herein, each of the following terms has the meaning associated with it in this section.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value, as such variations are appropriate.
Throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments there between. This applies regardless of the breadth of the range.
Referring now to
Arms 102a, 102b, 104a, 104b, bolts 108a-108d, and pins 112 are preferably constructed from a rigid material, such as a metal or a hard polymer such as PEEK. In various embodiments, the rigid material is a biocompatible material. In certain embodiments, each arm can comprise a surface that is textured or at least partially covered with barbs or spikes 116 to improve the attachment of device 100 within a space. In certain embodiments, each arm can terminate in a taper 105 at an anterior end, wherein taper 105 facilitates entry of expandable device 100 into a space.
In various embodiments, each arm can comprise a plurality of cavities. The cavities may be placed throughout each arm without compromising the rigidity of device 100. The cavities can be filled with any component that is synergistic with the function of device 100. For example, in some embodiments, the cavities can be packed with a biological material to promote the ingrowth of tissue, such as bone. In some embodiments, the cavities can be packed with a therapeutic to treat surrounding tissue. In some embodiments, one or more sensors can be inserted into the cavities to monitor the device and its environs, such as a temperature sensor, pressure sensor, corrosion sensor, and the like. In some embodiments, the cavities can be used to secure device 100 within a space, such as by accepting screws or cement. The cavities can also be used to view and monitor the progress of bone growth into the interior of device 100.
In some embodiments, an arm may further comprise features for engaging an insertion tool, described elsewhere herein. For example, arm 102a can comprise connector 120 sized to mate with an insertion tool. Connector 120 may be a hinged connector as shown in
Referring now to
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As shown in
The arrangement of bolts 108a-108d, pins 112, pin guides 130, cams 136, and opposing cam faces 124 and 126 synchronize the simultaneous movement between each arm 102a, 102b, 104a, and 104b. Shifting expandable device 100 from a closed configuration to an open configuration separates superior arms 102a and 102b from inferior arms 104a and 104b at the same rate and distance. Shifting expandable device 100 from a closed configuration to an open configuration also laterally separates arms 102a and 104a from arms 102b and 104b.
In some embodiments, arm 102a and 104a are in parallel alignment, and arm 102b and 104b are in parallel alignment, as visualized by longitudinal axis 124 running through the lengths of each arm in
The exemplary device 100 is depicted as having a polyhedron-like shape with four rectangular sides and a parallelogram-like top and bottom when closed (
In some embodiments, one or more of the connecting rods 110 can have a different length (not pictured). For example, bolt 108a and bolt 108c can be joined by a connecting rod 110a having a first length, and bolt 108b and bolt 108d can be joined by a connecting rod 110b having a second length, such that arms 102a and 104a are separated from the opposing arms 102b and 104b by the first length at one end and by a second length at an opposing end. In this manner, device 100 can thereby maintain a substantially rectangular top and bottom when closed, and has a substantially trapezoidal top and bottom when open.
In some embodiments, one or more of the bolts 108 can have pin guides with different open positions. For example, bolt 108a and bolt 108c can each have pin guides with an open position at a first height, and bolt 108b and bolt 108d can each have pin guides with an open position at a second height, such that superior arms 102a and 102b are separated from inferior arms 104a and 104b by a first height at one end and by a second height at an opposing end. In this manner, device 100 can thereby maintain substantially rectangular sides when closed, and has a lordotic angle with a substantially trapezoidal left and right side when open.
Device 100 can have any suitable dimensions between its closed and open configurations. For example, in certain embodiments, device 100 can have a closed length of between 30 mm to 30 cm, a closed width of between 7 mm to 7 cm, and a closed height of between 8 mm and 8 cm. In certain embodiments, device 100 can have an open length of between 20 mm to 20 cm, an open width of between 10 mm to 10 cm, and an open height of between 10 mm and 10 cm. The surface area and footprint of device 100 will depend on the length, width, and height, and will change accordingly between open and closed configurations. The surface area of device 100 will further depend on modifications to device 100, such as the number of cavities. In one embodiment, an exemplary device 100 has a closed length, width, and height of 34.81 mm, 7.94 mm, and 8 mm, respectively; an open length, width and height of 27.36 mm, 17.27 mm, and 10.63 mm, respectively; a closed footprint and footprint surface area of 221.16 mm2 and 165.84 mm2, respectively; and an open footprint and footprint surface area of 361.68 mm2 and 184.02 mm2, respectively.
Referring now to
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In
In
In
The devices of the present invention can be made using any suitable method known in the art. The method of making may vary depending on the materials used. For example, devices substantially comprising a metal may be milled from a larger block of metal or may be cast from molten metal. Likewise, components substantially comprising a plastic or polymer may be milled from a larger block, cast, or injection molded. In some embodiments, the devices may be made using 3D printing or other additive manufacturing techniques commonly used in the art.
The present invention also includes methods of using articulating expandable devices. As described elsewhere herein, the articulating expandable devices of the present invention can navigate corners and are switchable between a compact closed configuration and an expanded open configuration and are capable of withstanding compressive forces in the expanded open configuration. The expandable devices are useful in any application requiring the maintenance of a space under load.
In one embodiment, the articulating expandable devices of the present invention are useful as interbody devices. For example, in the case of intervertebral disc removal in a patient, the articulating expandable devices of the present invention are useful as an interbody device to complete a spinal fusion procedure. Contemplated procedures include but are not limited to posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF), lateral (trans-psoas) approaches, oblique approaches, and anterior lumbar interbody fusion (ALIF) procedures. The rigidity of the articulating expandable devices enables stable, long term maintenance of a disc space void in an open configuration. The articulating expandable devices can also be inserted in a less invasive manner due to their compact closed configuration. In a typical spinal fusion procedure, a skin incision is made adjacent to an intervertebral disc that requires removal. The disc space is identified, and the annulus of the disc is opened. Any suitable tools and techniques may be used to evacuate the intervertebral disc from the disc space and to prepare the adjoining bony endplates for good bony ingrowth.
Once the disc space has been prepared, an expandable device of the present invention may be used to fuse the spine. Referring now to
In other embodiments, the expandable devices of the present invention are useful as mechanical spacers. For example, in any various mechanical applications, there may be a need to temporarily or permanently provide a support within a space. As described elsewhere herein, the expandable devices of the present invention can further include one or more sensors for monitoring performance, including temperature sensors, gyroscopes, pressure sensors, corrosion sensors, and the like.
With reference now to
Referring now to
With reference now to
Additionally, in one embodiment, a deployment instrument includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, wherein at least one of the stabilization retainer and deployment driver is translatable along the central axis. In one embodiment, only the deployment driver is translatable along the central axis. In one embodiment, the deployment driver is slidably translatable along the central axis. In one embodiment, the proximal handle includes one or more features selected from the group consisting of (i) an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism selected from the group consisting of sliding rail, ratchet, worm gear, screw, cam and follower, lever, gear, spring, and combinations thereof; (ii) a slap hammer surface; and (iii) combinations thereof. In one embodiment, the proximal handle includes an actuator that drives translation of the deployment driver along the central axis, the actuator comprising corresponding threaded engagement between a proximal portion of the deployment driver and a housing portion of the proximal handle, wherein the threaded engagement can drive movement of the deployment driver along the central axis. In one embodiment, the proximal handle includes a lock that prevents actuation of translation of the deployment driver along the central axis. In one embodiment, one or both of the stabilization retainer and the pivot arm of the deployment is forked at its distal end the forks including opposing pins that form a hinged connector with a pivot axis. In one embodiment, only the stabilization retainer is forked at its distal end, the fork including opposing pins that form a hinged connector with a pivot axis. In one embodiment, the stabilization retainer includes at its distal end a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector. In one embodiment, the stabilization retainer includes at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the opposing pair of retaining pins forming a hinged connector. In one embodiment, the device includes a locking sleeve that is slidable along the central axis over the stabilization retainer to releasably compress the opposing fork arms. In one embodiment, the locking sleeve comprises a wedge that is positionable between the opposing fork arms, such that when the wedge is positioned most distally relative to the fork arms, the fork arms are in a relaxed orientation, and when the wedge is moved proximally by translation of the sleeve proximally along the stabilization retainer, the wedge contacts the opposing fork arms into an expanded orientation and the opposing retaining pins are displaced away from each other. In one embodiment, the proximal handle includes a lock that retains the locking sleeve in place to compress the opposing fork arms. In one embodiment, the hingedly connected pivot arm on the deployment driver includes a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector, wherein each of the retaining pins projects outward from the pivot arm. In one embodiment, the hingedly connected pivot arm on the deployment driver includes at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the pair of opposing retaining pins forming a hinged connector.
In one embodiment, a deployment instrument, includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, the stabilization retainer including at its distal end a first pair of retaining pins oriented along an axis that is transverse to the central axis, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, the pivot arm including at a distal end a second pair of retaining pins, wherein at least one of the stabilization retainer and deployment driver is slidably translatable along the central axis.
In one embodiment, a deployment instrument includes a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, the stabilization retainer including at its distal end a pair of opposing fork arms and a pair of opposing retaining pins, each one of the pair of retaining pins oriented distally on a fork arm, the opposing pair of retaining pins forming a hinged connector, a locking sleeve that is slidable along the central axis over the stabilization retainer to releasably compress the opposing fork arms, the locking sleeve comprising a wedge that is positionable between the opposing fork arms, such that when the wedge is positioned most distally relative to the fork arms, the fork arms are in a relaxed orientation, and when the wedge is moved proximally by translation of the sleeve proximally along the stabilization retainer, the wedge contacts the opposing fork arms into an expanded orientation and the opposing retaining pins are displaced away from each other, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, the pivot arm including at its distal end a pair of retaining pins oriented along an axis that is transverse to the central axis and forming a hinged connector, wherein each of the retaining pins projects outward from the pivot arm, wherein the handle includes an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism the proximal handle includes one or more features selected from the group consisting of (i) an actuator that drives translation of the deployment driver along the central axis, the actuator comprising a mechanism selected from the group consisting of sliding rail, ratchet, worm gear, screw, cam and follower, lever, gear, spring, and combinations thereof; (ii) a slap hammer surface; and (iii) combinations thereof.
Embodiments of the invention may also be embodied as a device kit, or included as a component of a device kit. For example, in one embodiment, an articulating expandable device kit includes an articulating expandable device having a first and a second superior arm and a first and a second inferior arm, the first superior arm further comprising a hinged connector extending from its posterior end, and the second superior arm further comprising a socket extending from its posterior end; and a deployment instrument having a proximal handle, a stabilization retainer extending parallel to a central axis from the proximal handle to a distal end of the deployment instrument, and a deployment driver extending parallel to the stabilization retainer along the central axis, the deployment driver including at its distal end a hingedly connected pivot arm, wherein at least one of the stabilization retainer and deployment driver is translatable along the central axis. In one embodiment, the articulating expandable device is configured to removably attach to the deployment instrument in a closed configuration by hingedly engaging the connector to the stabilization retainer and engaging the socket to the pivot arm of the deployment driver wherein the articulating expandable device includes positive stop features that retain the articulating expandable device in the closed configuration that is aligned with the central axis of the deployment instrument, and wherein actuating translation of the deployment driver along the central axis to drive the pivot arm distally, the pivot arm is driven to rotate driving the engaged socket to translate the articulating expandable device into an open configuration and oriented substantially transverse to the central axis.
The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.
This application claims priority to U.S. provisional application No. 63/213,282 filed on Jun. 22, 2021 incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US22/34514 | 6/22/2022 | WO |
Number | Date | Country | |
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63213282 | Jun 2021 | US |