Expandable device

Abstract

The present invention provides an expandable device and an insertion tool for deploying the expandable device. The expandable device can increase in height and width when expanding from a closed configuration to an open configuration to occupy a larger volume and present a larger surface area. The expandable device is lockable and can rigidly occupy a gap after expansion. In some embodiments, the expandable device can be used as an intervertebral fusion cage for spinal fusion.

Description

[0001] This application is a divisional application of the invention patent application which entered the Chinese national phase on May 28, 2020, with PCT international application number PCT / US2018 / 053716, application date October 1, 2018, Chinese application number 201880077175.9, and invention name “Expandable Device”. All contents are incorporated herein by reference.

[0002] Citations of Related Applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 565,374, filed on September 29, 2017, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present application relates to an expandable device and a method for deploying an expandable device. Background Art

[0005] Some spinal fusion surgeries remove degenerated disc material and fill the intervertebral space to maintain separation between adjacent vertebrae. While some procedures fill the intervertebral space with bone-forming tissue, others insert a rigid device to more securely separate the vertebrae. To minimize recovery time and surgical tissue damage, it is advantageous for the rigid device insert to have a low profile for minimally invasive incisions while also having a large footprint to maximize disc space stability.

[0006] Therefore, there is a need in the art for a compact, rigid device that can expand to occupy a larger footprint. The present invention satisfies this need. Summary of the Invention

[0007] In one aspect, the present invention relates to an expandable device comprising: first and second upper arms and first and second lower arms, each arm having a front end and a rear end and a top surface and a bottom surface, and each arm having a front opening and a rear opening passing through the top surface and the bottom surface, wherein the first upper arm is positioned above the first lower arm with the front opening and the rear opening aligned, and the second upper arm is positioned above the second lower arm with the front opening and the rear opening aligned; four cylindrical bolts respectively located in each opening of the arm, each bolt having a top end, a bottom end, an outer surface and a first, second, third and fourth slots in the outer surface; wherein the first slot and the second slot of each bolt are positioned relative to each other and extend from near the middle of each bolt to the top end of each bolt, and the third slot and the fourth slot of each bolt are positioned relative to each other and extend from near the middle of each bolt to the bottom end of each bolt; a first rod connected to each bolt located in the front opening of the arm, and a second rod connected to each bolt located in the rear opening of the arm; and a plurality of pins, each pin being connected to the inner surface of each opening of the arm and slidably engaged to the slot of the bolt located in the corresponding opening.

[0008] In one embodiment, each of the four arms is substantially parallel to each other in the closed configuration.In one embodiment, the four arms can move about the four bolts while maintaining alignment that is substantially parallel to each other.

[0009] In one embodiment, the first and second slots of each bolt extend in a bend of approximately 90 degrees from about the middle of each bolt around the outer surface toward the top end of each bolt, and wherein the third and fourth slots of each bolt extend in a bend of approximately 90 degrees from about the middle of each bolt around the outer surface toward the bottom end of each bolt.

[0010] In one embodiment, the device includes a closed configuration that positions the four arms adjacent to each other and positions the plurality of pins near the middle of each bolt. In one embodiment, the device includes 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.

[0011] In one embodiment, at least one arm comprises a locking drill bit drivable into the bolt. In one embodiment, each arm comprises one or more cavities. In one embodiment, the cavities are pre-filled with bone tissue. In one embodiment, the cavities are pre-filled with a therapeutic agent selected from the group consisting of: a stem cell population, an anti-inflammatory agent, an antibiotic, and an antiviral agent. In one embodiment, the cavities are sized to accommodate a sensor selected from the list consisting of: a temperature sensor, a pressure sensor, a corrosion sensor, and a gyroscope. In one embodiment, the device is sized to fit within an intervertebral disc space.

[0012] In one embodiment, the first upper arm includes a connector extending from a rear end thereof and the second upper arm includes a slot extending from a rear end thereof. In one embodiment, the first upper arm and the first lower arm each include a connector extending from a rear end thereof. In one embodiment, the first upper arm includes a connector extending from a rear end thereof and the second arm includes a crosspiece.

[0013] On the other hand, the present invention relates to an insertion tool for expanding the expandable device of the present invention, the insertion tool comprising: a tubular shell comprising a rotating part, a non-rotating part and an inner cavity extending through the entire shell; an elongated clamp positioned in the inner cavity and extending from the tubular shell in a forward direction, the clamp being engageable to the connector of the first upper arm; and an anchor rod that can be fixed to the non-rotating part in a forward direction, the anchor rod being engageable with a slot of the second upper arm.

[0014] In one embodiment, the anchor rod holds the second upper arm in a stationary position while the clamp is movable in an anterior and posterior direction to move the first upper arm. In one embodiment, the clamp is movable by actuating a rotating portion of the housing. In one embodiment, the insertion tool further includes a drill driver that is engageable with a locking drill bit positioned in the connector of the first upper arm.

[0015] On the other hand, the present invention relates to an insertion tool for expanding the expandable device of the present invention, the insertion tool comprising: a tubular shell comprising a rear rotating portion, a front hinged portion which divides the shell into an upper half of a connector connectable to a first upper arm and a lower half of a connector connectable to a first lower arm, and an inner cavity extending through the entire tubular shell, a wedge-shaped rod positioned within the inner cavity, the wedge-shaped rod comprising a front wedge-shaped head located within the inner cavity of the hinged portion; and an elongated hook-shaped member which can slide along the outside of the tubular shell, the elongated hook member comprising a front hook which can engage with the second rod of the expandable device.

[0016] In one embodiment, the wedge-shaped rod is movable in a rearward direction to open the hinged portion using the wedge-shaped head and deploy the connected first upper arm and first lower arm of the expandable device. In one embodiment, the wedge-shaped rod is movable by a rotating portion of the actuating housing. In one embodiment, the elongated hook member is movable in a rearward direction to pull the engaged second rod of the expandable device. In one embodiment, the movement of the elongated hook member is coupled to the movement of the wedge-shaped rod. In one embodiment, the coupled movement of the elongated hook member and the wedge-shaped rod simultaneously deploys the connected first upper arm and first lower arm and pulls the engaged second rod of the expandable device.

[0017] On the other hand, the present invention relates to an insertion tool for expanding the expandable device of the present invention, the insertion tool comprising: a tubular shell having a rotating portion, a non-rotating portion and an inner cavity extending throughout the shell; a pair of expandable clamps extending in a forward direction from the non-rotating portion, the clamps being engageable to the connector of the first upper arm; a locking sleeve that can slide over the pair of clamps; and an elongated deployment driver located in the inner cavity of the shell, the deployment driver having a front pin that can engage with a slot in the second upper arm.

[0018] In one embodiment, positioning the locking sleeve in a forward-most position secures the pair of clamps to the connector of the first upper arm, maintaining it in a stationary position while the deployment actuator is movable in forward and rearward directions to move the second upper arm. In one embodiment, the deployment actuator is movable by actuating a rotating portion of the housing. In one embodiment, the pair of clamps includes an internal cavity sized to accommodate a drill driver that can engage a locking drill bit positioned in the connector of the first upper arm.

[0019] On the other hand, the present invention relates to an insertion tool for expanding the expandable device of the present invention, which insertion tool includes: a slender shaft having a coupling member located at the front end; and a slender pull rod adjacent to the slender shaft, which has a front hook that can engage with the cross piece of the second rod of the expandable device.

[0020] In one embodiment, the shaft holds the first upper arm in a stationary position, while the pull rod is movable in a rearward direction to pull the second rod of the expandable device. In one embodiment, the engagement member comprises a screw. In one embodiment, the pull rod can be replaced with an elongated push rod having a front stirrup that engages a crosspiece of the second rod of the expandable device. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The following detailed description of exemplary embodiments of the invention will be better understood when read in conjunction with the accompanying 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.

[0022] Figures 1A to 1D A perspective view of an exemplary expandable device is depicted. Figure 1A and Figure 1C The device is depicted in a closed configuration. Figure 1B and Figure 1D The device is depicted in an open configuration.

[0023] Figures 2A to 2C Depicted is a view of an exemplary expandable device's bolt and a pin guide within the bolt that is used to open and close the device. Figure 2AIn the figure, the top image depicts two bolts connected by a rod, the lower left image depicts a bolt and the closed position of each pin guide, and the lower right image depicts the same bolt rotated approximately 90 degrees to show the open position of each pin guide. Figure 2B and Figure 2C , external components of the device have been removed to illustrate the movement of internal components.

[0024] Figure 3A and Figure 3B Depicted is a top view of an exemplary expandable device and locking mechanism.

[0025] Figure 4 Depicted is a perspective view of an exemplary insertion tool for deploying the expandable device of the present invention.

[0026] Figures 5A to 5C A partial wireframe diagram of an exemplary insertion tool is depicted to illustrate internal components.

[0027] Figure 6A and Figure 6B Various views of the front tip of an exemplary insertion tool are depicted.

[0028] Figure 7A and Figure 7B An exemplary insertion tool is depicted that is secured to a closed expandable device ( Figure 7A ) and is actuated to open and lock the expandable device ( Figure 7B ).

[0029] Figure 8A and Figure 8B Depicts the closed configuration ( Figure 8A ) and in the open configuration ( Figure 8B ) is a perspective view of an exemplary expandable device.

[0030] Figure 9A and Figure 9B Depicts the closed configuration ( Figure 9A ) and in the open configuration ( Figure 9B ) with exterior components removed to illustrate movement of interior components.

[0031] Figure 10 Depicted is a perspective view of an exemplary insertion tool for deploying the expandable device of the present invention.

[0032] Figure 11 A partial wireframe diagram of an exemplary insertion tool is depicted to illustrate internal components.

[0033] Figure 12A and Figure 12B A partial, enlarged wireframe view of a rear portion of an exemplary insertion tool is depicted.

[0034] Figure 13A and Figure 13B Depicts the closed configuration ( Figure 13A ) and the open configuration ( Figure 13B ) is a partial wireframe diagram of an exemplary insertion tool wedge system.

[0035] Figure 14 A perspective view of the leading end of an exemplary insertion tool is depicted.

[0036] Figure 15 The leading end of an exemplary insertion tool is depicted juxtaposed adjacent to an exemplary expandable device.

[0037] Figure 16A and Figure 16B Depicts an exemplary insertion tool coupled to an exemplary expandable device ( Figure 16A ) and an insertion tool having opened the expandable device ( Figure 16B ).

[0038] 17A to 17D Depicted is a perspective view of an exemplary expandable device in a closed configuration.

[0039] Figure 18A and Figure 18B Depicted are perspective and top views, respectively, of a first link connecting two bolts of an exemplary expandable device.

[0040] Figure 18C and Figure 18D A perspective view and a top view, respectively, of a second link connecting two bolts of an exemplary expandable device are depicted.

[0041] Figure 19 The interior of an exemplary expandable device arm is depicted in isolation.

[0042] 20A to 20C Perspective, top, and rear views of an exemplary expandable device in an open configuration are depicted.

[0043] Figure 21 A perspective view of an exemplary insertion tool is depicted.

[0044] 22A to 22D Depicted is a perspective view of an exemplary insertion tool coupled to an exemplary expandable device.

[0045] Figure 23A and Figure 23B Depicted are a driver horn and deployment driver of an exemplary insertion tool, and a driver horn coupled to an exemplary expandable device, respectively.

[0046] Figure 24A perspective view of an exemplary insertion tool is depicted indicating the operation of actuating a deployment actuator.

[0047] 25A to 25D Depicted is a sequence for using an exemplary insertion tool to transition an exemplary expandable device from a closed configuration to an open configuration.

[0048] Figure 26A and Figure 26B Depicted is the use of a locking actuator with an exemplary insertion tool to lock an exemplary expandable device in an open configuration.

[0049] Figures 27A to 27C A funnel is depicted being used with an exemplary insertion tool to introduce material into an open exemplary expandable device.

[0050] Figure 28A and Figure 28B Perspective views of the leading end of an exemplary expandable device and an exemplary insertion device are depicted, respectively, in a closed configuration.

[0051] Figure 29A and Figure 29B A perspective view of an exemplary expandable device coupled to an exemplary insertion device is depicted.

[0052] Figure 30A and Figure 30B A pull rod of an exemplary insertion tool and a pull rod coupled to an exemplary expandable device are depicted separately.

[0053] Figures 31A to 31E Depicted is a sequence for using an exemplary insertion tool to transition an exemplary expandable device from a closed configuration to an open configuration.

[0054] Figure 32A and Figure 32B A push rod of an exemplary insertion tool and a push rod coupled to an exemplary expandable device are depicted separately.

[0055] Figure 33 A flow chart of an exemplary method for using an expandable body device in spinal fusion surgery. DETAILED DESCRIPTION

[0056] The present invention provides an expandable device and an insertion tool for deploying the expandable device. The expandable device can increase in height and width when expanded from a closed configuration to an open configuration to occupy a larger volume and present a larger surface area. The expandable device is lockable and can rigidly occupy a gap after expansion. In some embodiments, the expandable device can be used as an intervertebral fusion cage for spinal fusion.

[0057] definition

[0058] Should be understood that, the accompanying drawings and description of the present invention have been simplified to illustrate the elements relevant to a clear understanding of the present invention, while for the sake of clarity, many other elements commonly found in this area have been eliminated. Those of ordinary skill in the art will recognize that other elements and / or steps are desired and / or required when realizing the present invention. However, since such elements and steps are well known in the art, and because they do not promote a better understanding of the present invention, the discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications of such elements and methods well known to those skilled in the art.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the 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, exemplary methods and materials are described.

[0060] As used herein, each of the following terms has the meaning associated with it in this section.

[0061] The articles "a" and "an" are used herein to refer to one or more than one (ie, to at least one) of the grammatical object of the article. For example, "an element" means one element or more than one element.

[0062] As used herein, "about" when referring to a measurable value such as an amount, a duration of time, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, and ±0.1 relative to the specified value, provided such variations are appropriate.

[0063] Throughout this disclosure, various aspects of the present invention may be presented in range format. It should be understood that the description of range format is for convenience and brevity only and should not be construed as an inflexible limitation on the scope of the present invention. Therefore, it should be considered that the description of a range has specifically disclosed all possible subranges and each numerical value within the range. For example, a description of a range such as 1 to 6 should be considered to have clearly disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, and individual digits within the range, such as 2.7, 3, 4, 5, 5.3, and 6, and all increments and local increments therebetween. This applies regardless of the breadth of the range.

[0064] first expandable device

[0065] Now refer to Figures 1A to 1D, which depicts an exemplary expandable device 100. The expandable device 100 includes four arms (a first upper arm 109a, a second upper arm 109b, a third lower arm 110a, and a fourth lower arm 110b) and four movable bolts 112 (referred to herein as a first rear bolt 112a, a second front bolt 112b, a third rear bolt 112c, and a fourth front bolt 112d). Each arm includes two slots 111 sized to accommodate the movable bolts 112. Each bolt 112 is secured within the slot 111 by a pin 114 secured to each arm, and the bolts 112a-112d are secured in pairs by connecting rods 124 (112a connected to 112c, 112b connected to 112d), which are described elsewhere herein.

[0066] The arms 109a, 109b, 110a, 110b, bolts 112a-112d, and pin 114 are preferably constructed of a rigid material such as metal or a hard polymer. In various embodiments, the rigid material is a biocompatible material. In certain embodiments, each arm may include a textured surface or a surface at least partially covered with barbs or spikes to improve attachment of the expandable device 100 within the gap.

[0067] In various embodiments, each arm may include multiple cavities 116. Cavities 116 can be placed on each arm without compromising the rigidity of expandable device 100. Cavities 116 can be filled with any component that cooperates with the function of expandable device 100. For example, in some embodiments, cavities 116 can be filled with a biomaterial to promote the ingrowth of tissue such as bone. In some embodiments, cavities 116 can be filled with a therapeutic agent for treating surrounding tissue. In some embodiments, one or more sensors such as temperature sensors, pressure sensors, corrosion sensors, etc. can be inserted into cavities 116 to monitor the device and its surrounding environment. In some embodiments, cavities 116 can be used to secure expandable device 100 within a gap by accepting screws or cement. Cavities 116 can also be used to view and monitor the progress of bone growth into the interior of expandable device 100.

[0068] In various embodiments, each arm can include one or more fins 117 to increase the surface area of ​​the top and bottom of expandable device 100. Fins 117 can be sized to interlock when expandable device 100 is closed to reduce the footprint of expandable device 100.

[0069] As described elsewhere herein, in some embodiments, the arms may also include features for engaging an insertion tool. For example, the arm 109a may include a connector 118 having a threaded interior sized to fit over a drill bit 120. The connector 118 includes one or more attachment features 119 to mate with an insertion tool. The attachment features 119 may be, for example, Figure 1C and Figure 1D The notch shown may be adapted to accommodate a fixture of an insertion tool. Alternatively, the attachment feature 119 may be threaded to threadably engage an engagement tool. The locking drill bit 120 may be actuated to lock into the bolt 112, thereby preventing the expandable device 100 ( Figure 3A , Figure 3B As described elsewhere herein, in another example, the arm 109b can include a slot 122 to accommodate insertion of a rod of a tool.

[0070] Now refer to Figures 2A to 2C , which depicts a bolt 112. The bolts 112 are paired together by a connecting rod 124. Each bolt 112 includes a cylindrical shape having a top end, a bottom end, and an outer surface. Each bolt 112 includes four pin guides 126 cut into the outer surface. Each pin guide 126 is a curved slot having a closed position 128 near the center of the bolt 112 and an open position 130 near the top and bottom of the bolt 112. The closed position 128 and the open position 130 are positioned approximately 90 degrees apart from each other on the outer surface. The pin guides 126 are arranged in opposing pairs on the bolt 112 on the upper and lower halves of the bolt 112 so that the pin 114 can extend through a pair of opposing pin guides 126.

[0071] exist Figure 2B and Figure 2C, expandable device 100 is depicted without arms 109b and 110b to illustrate the arrangement of bolts 112a-112d and the mechanism by which bolts 112a-112d, pins 114, and arms open and close in a synchronized manner. In this embodiment, each arm 109a, 109b, 110a, and 110b is aligned parallel or substantially parallel to one another (visualized by an arm axis 134 extending the length of each arm), and each arm includes a securing pin 114 that passes through a pair of opposing pin guides 126 to secure a bolt 112 in each of its two slots 111. Pins 114 are secured relative to each arm such that each pin 114 is arranged parallel or substantially parallel to one another (visualized by a pin axis 132 extending the length of each pin 114). Rotating bolt 112 causes pin 114 to slide within pin guides 126 between a closed position 128 and an open position 130. Thus, the height difference between the closed position 128 and the open position 130 increases the distance between the pins 114, which also separates the upper arms 109a and 109b from the lower arms 110a and 110b. Figure 3A and Figure 3B It is shown that when the expandable device 100 is transformed between the closed configuration and the open configuration, the parallel alignment between the arm 109a on one side (and the arm 110a below) and the arm 109b on the other side (and the arm 110b below) is maintained (visualized by the parallel arm axes 134) and the parallel alignment between the pins 114 (visualized by the parallel pin axes 132). Figure 3A and Figure 3B Also shown is the distance separation between arms 109a and 110a on one side and arms 109b and 110b on the opposite side caused by transitioning expandable device 100 between the closed and open configurations due to the length of linkage 124.

[0072] The exemplary expandable device 100 is depicted as having a polyhedral shape with four rectangular sides and a parallelogram-shaped top and bottom when closed ( Figure 1A ), and having a polyhedral shape with four rectangular sides and rectangular top and bottom when it is opened ( Figure 1B ). However, it should be understood that expandable device 100 is not limited to the shape depicted and can have any suitable shape. For example, each arm can include a semicircular shape so that expandable device 100 has an overall cylindrical shape with curved sides and a rounded or oval top and bottom.

[0073] In some embodiments, one or more of the links 124 can have different lengths (not shown). For example, bolt 112a and bolt 112c can be connected by a link 124 having a first length, and bolt 112c and bolt 112d can be connected by a link 124 having a second length, such that arms 109a and 110a are separated from opposing arms 109b and 110b by a first length at one end and a second length at an opposite end. Thus, expandable device 100 can maintain a substantially rectangular top and bottom when closed and have a substantially trapezoidal top and bottom when open.

[0074] In some embodiments, one or more bolts 112 may have pin guides 126 with different open positions 130 (not shown). For example, bolts 112a and 112c may each have pin guides 126 with open positions 130 at a first height, and bolts 112b and 112d may each have pin guides 126 with open positions 130 at a second height, such that upper arms 109a and 109b are separated from lower arms 110a and 110b by a first height at one end and a second height at an opposite end. Thus, expandable device 100 can maintain substantially rectangular sides when closed and have substantially trapezoidal left and right lordotic corners when open.

[0075] The expandable device 100 can have any suitable dimensions between its closed configuration and open configuration. For example, in certain embodiments, the expandable device 100 can have a closed length between 30 mm and 30 cm, a closed width between 7 mm and 7 cm, and a closed height between 8 mm and 8 cm. In certain embodiments, the expandable device 100 can have an open length between 20 mm and 20 cm, an open width between 10 mm and 10 cm, and an open height between 10 mm and 10 cm. The surface area and footprint of the expandable device 100 will depend on the length, width, and height, and will vary accordingly between the open configuration and the closed configuration. The surface area of ​​the expandable device 100 will further depend on modifications to the expandable device 100, such as the number of cavities 116 and the size and overlap of the fins 117. In one embodiment, the exemplary expandable device 100 has a closed length, width, and height of 34.81 mm, 7.94 mm, and 8 mm; an open length, width, and height of 27.36 mm, 17.27 mm, and 10.63 mm; and an open length, width, and height of 221.16 mm. 2 and 165.84mm 2 of enclosed footprint and floor space surface area; and 361.68mm 2 and 184.02mm 2 of open floor space and floor space surface area.

[0076] First insertion tool for the first expandable device

[0077] Now refer to Figure 4 , which depicts an exemplary insertion tool 200. The insertion tool 200 includes a front end 202, a rear end 204, a non-rotating handle 210, a rotating handle 211, a clamp 214, a locking drill driver 216, and an anchor 218. Figures 5A to 5C The interior of the insertion tool 200 is shown in more detail in FIG.

[0078] The non-rotating handle 210 and the rotating handle 211 are connected by a flange 212, about which the rotating handle 211 can be freely twisted. The rotating handle 211 has a hollow interior comprising threads 213 and a lumen connected to the lumen of the non-rotating handle 210. A clamp 214 is located within the continuous lumen of the non-rotating handle 210 and the rotating handle 211. The clamp 214 comprises an elongated tubular shape with a lumen extending throughout the clamp and is angled by a hook 224 at the front end 202 and a threaded portion 215 at the rear end 204. The threaded portion 215 mates with the threads 213 within the hollow interior of the rotating handle 211, so that twisting the rotating handle 211 twists the threads 213, advancing the clamp 214 in either a forward or rearward direction. The clamp 214 may also include a tab 220 mounted within the non-rotating handle 210 to prevent the clamp 214 from rotating within the insertion tool 200.

[0079] The locking drill driver 216 is located in the inner cavity of the clamp 214 and is free to twist and slide within the clamp 214. The locking drill driver 216 includes an elongated rod shape and has a Figure 6A 、 Figure 6B ) is tilted by the driver 226. At the rear end 204, the locking drill driver 216 may include any suitable handle or grip.

[0080] Now refer to Figure 6A and Figure 6B , which depicts the configuration of the front end 202 of the insertion tool 200. An anchor 218 is a rigid member that extends from the non-rotating handle 210 in a forward direction adjacent to the clamp 214 and the locking drill driver 216. The anchor 218 is loosely connected to the non-rotating handle 210 so that the anchor 218 can freely pivot in the horizontal plane. In some embodiments, the anchor 218 is constrained from deviating from the horizontal plane. As described elsewhere herein, the anchor 218 includes an upturned front end that can be connected to an expandable device.

[0081] A slit 222 is cut into the front end of the clamp 214 to form a bendable portion that extends beyond the front end of the clamp 214 and terminates in a hook 224. Figure 6B, a partial wireframe view of the clamp 214 depicts ridges 230 located on the inner surface of the bendable portion. Figure 6B The front end of the locking drill driver 216 is also depicted, with a recess positioned adjacent the head 228 of the locking drill driver 216 to accommodate the ridge 230. In this arrangement, sliding the locking drill driver 216 in a rearward direction within the clamp 214 brings the head 228 into contact with the ridge 230. Further rearward movement wedges the head 228 under the ridge 230, causing the bendable portion of the clamp 214 and the hook 224 to bend away from the head 228.

[0082] Now refer to Figure 7A and Figure 7B , which depicts the insertion tool 200 being coupled to the expandable device 100 and opening the expandable device 100. Figure 7A 109a and 109b, respectively. The hook 224 of the clamp 216 is inserted into the attachment feature 119 of the arm 109a, and the upturned front end of the anchor 218 is inserted into the slot 122 of the arm 109b. To open the expandable device 100, the rotating handle 211 is twisted while the non-rotating handle 210 remains snap-fastened, causing the clamp 216 to advance in the rotating handle 211 in an anterior direction. The forward movement of the clamp 216 pushes the arm 109a in an anterior direction, while the rigid anchor 218 holds the arm 109b in place, preventing the arm 109b from moving in an anterior direction. Repositioning of arm 109a relative to arm 109b results in a synchronized series of movements in which the pin 114 in arm 109a moves through the pin guide 126, causing the associated bolt 112 and the opposing bolt 112 connected by the connecting rod 124 to rotate, thereby positioning all of the pins 114 so that they are in the same position as shown in FIG. Figure 7B Shown is the open position 130. The expandable device 100 can be closed by twisting the rotary handle 211 in the opposite direction, which advances the clamp 216 and arm 109a in the rear direction and reverses the above-described motion.

[0083] The expandable device 100 can be locked in any position between its open configuration and its closed configuration by sliding the locking drill driver 216 to its forward-most position to seat the driver 226 in the locking drill 120. The locking drill driver 216 can be twisted to drive the locking drill 120 into the adjacent bolt 112, thereby locking its rotation and the movement of every other interconnecting member. The locking drill driver 216 can then be slid to its rearmost position, whereby the head 228 of the locking drill driver 216 pushes the ridge 230 apart to disengage the hook 224 from the attachment feature 119, thereby detaching the insertion tool 200 from the expandable device 100.

[0084] Second expandable device

[0085] Now refer to Figure 8A and Figure 8B , which depicts an exemplary expandable device 300. The expandable device 300 includes four arms (a first upper arm 309a, a second upper arm 309b, a first lower arm 310a, and a second lower arm 310b) and four movable bolts 312 (referred to herein as a first rear bolt 312a, a second front bolt 312b, a third rear bolt 312c, and a fourth front bolt 312d). Each arm includes two slots 311 sized to accommodate the movable bolts 312. Figure 9A and Figure 9B As shown, each bolt 312 is secured in the slot 311 by a pin 314 secured to each arm, and the bolts 312a-312d are secured in pairs by connecting rods 324 (312a connected to 312c, 312b connected to 312d).

[0086] The arms 309a, 309b, 310a, 310b, bolts 312a-312d, and pin 314 are preferably constructed of a rigid material such as metal or a hard polymer. In various embodiments, the rigid material is a biocompatible material. In certain embodiments, the arms 310 may include a textured surface or a surface at least partially covered with barbs or spikes to improve attachment of the expandable device 300 within the gap.

[0087] In various embodiments, each arm may include multiple cavities 316. Cavities 316 can be placed on each arm 310 without compromising the rigidity of the expandable device 300. Cavities 316 can be filled with any component that cooperates with the function of the expandable device 300. For example, in some embodiments, cavities 316 can be filled with a biomaterial to promote the ingrowth of tissue such as bone. In some embodiments, cavities 316 can be filled with a therapeutic agent for treating surrounding tissue. In some embodiments, one or more sensors such as temperature sensors, pressure sensors, corrosion sensors, etc. can be inserted into cavities 316 to monitor the device and its surrounding environment. In some embodiments, cavities 316 can be used to secure the expandable device 300 within the gap by accepting screws or cement. Cavities 316 can also be used to view and monitor the progress of bone growth into the interior of the expandable device 300.

[0088] In various embodiments, each arm can include one or more fins 317 to increase the surface area of ​​the top and bottom of the expandable device 300. The fins 317 can be sized to interlock when the expandable device 300 is closed to reduce the footprint of the expandable device 300.

[0089] As described elsewhere herein, in some embodiments, the arms can further include features for engaging an insertion tool. For example, as described elsewhere herein, arms 309a and 310a can include connectors 318a and 318b, respectively, to engage a pry bar of an insertion tool. As described elsewhere herein, in certain embodiments, arm 309a can further include gaps 320 to facilitate engagement of a link arm hook of an insertion tool.

[0090] exist Figure 9A and Figure 9B , the expandable device 300 has been depicted without arms 309b and 310b to illustrate the arrangement of bolts 312a-312d and the mechanism by which bolts 312a-312d, pins 314, and arms open and close in a synchronized manner. The structure of bolt 312 is similar to that of the above and Figure 2A 3. The structure described above for bolt 112 in FIG. In this embodiment, each arm 309a, 309b, 310a and 310b is aligned parallel or substantially parallel to one another (visualized by an arm axis 334 extending the length of each arm), and each arm includes a retaining pin 314 that passes through a pair of opposing pin guides 326 to secure a bolt 312 to each of its two slots 311. The pins 314 are fixed relative to each arm so that each pin 314 is arranged parallel or substantially parallel to one another (visualized by a pin axis 332 extending the length of each pin 314). Rotating the bolt 312 causes the pin 314 to slide in the pin guides 326 between a closed position 328 and an open position 330. Thus, the height difference between the closed position 328 and the open position 330 increases the distance between the pins 314, which also separates the upper arms 309a and 309b from the lower arms 310a and 310b. Similar to Figure 3A and Figure 3B , transitioning the expandable device 300 between the closed and open configurations maintains parallel alignment between the arms 309a on one side (and the arms 310a below) and the arms 309b on the opposite side (and the arms 310b below) and between the pins 314. Due to the length of the linkage 324, transitioning the expandable device 300 between the closed and open configurations also results in a distance separation between the arms 309a and 310a on one side and the arms 309b and 310b on the opposite side.

[0091] The exemplary expandable device 300 is depicted as having a polyhedral shape with four rectangular sides and a parallelogram-shaped top and bottom when closed ( Figure 8A ), and having a polyhedral shape with four rectangular sides and rectangular top and bottom when it is opened ( Figure 8B). However, it should be understood that expandable device 300 is not limited to the shape depicted and can have any suitable shape. For example, each arm can include a semicircular shape so that expandable device 300 has an overall cylindrical shape with curved sides and a rounded or oval top and bottom.

[0092] In some embodiments, one or more of the links 324 can have different lengths (not shown). For example, bolt 312a and bolt 312c can be connected by a link 324 having a first length, and bolt 312c and bolt 312d can be connected by a link 324 having a second length, such that arms 309a and 310a are separated from opposing arms 309b and 310b by a first length at one end and a second length at an opposite end. Thus, expandable device 300 can maintain a substantially rectangular top and bottom when closed and have a substantially trapezoidal top and bottom when open.

[0093] In some embodiments, one or more bolts 312 may have pin guides 326 with different open positions 330 (not shown). For example, bolts 312a and 312c may each have pin guides 326 with open positions 330 at a first height, and bolts 312b and 312d may each have pin guides 326 with open positions 330 at a second height, such that upper arms 309a and 309b are separated from lower arms 310a and 310b by a first height at one end and a second height at an opposite end. Thus, in this manner, expandable device 300 can maintain substantially rectangular sides when closed and have substantially trapezoidal left and right lordotic angles when open.

[0094] The expandable device 300 can have any suitable dimensions between its closed configuration and open configuration. For example, in certain embodiments, the expandable device 300 can have a closed length between 30 mm and 30 cm, a closed width between 7 mm and 7 cm, and a closed height between 8 mm and 8 cm. In certain embodiments, the expandable device 300 can have an open length between 20 mm and 20 cm, an open width between 10 mm and 10 cm, and an open height between 10 mm and 10 cm. The surface area and footprint of the expandable device 300 will depend on the length, width, and height, and will vary accordingly between the open configuration and the closed configuration. The surface area of ​​the expandable device 300 will further depend on modifications to the expandable device 300, such as the number of cavities 316 and the size and overlap of the fins 317. In one embodiment, the exemplary expandable device 300 has a closed length, width, and height of 31.33 mm, 7.55 mm, and 8 mm; an open length, width, and height of 25.03 mm, 13.83 mm, and 10.62 mm; a closed footprint and footprint surface area of ​​195.52 mm2 and 141.15 mm2; and an open footprint and footprint surface area of ​​299.07 mm2 and 158.53 mm2.

[0095] Second insertion tool for the second expandable device

[0096] Now refer to Figure 10 , which depicts an exemplary insertion tool 400. The insertion tool 400 includes a front end 402, a rear end 404, a housing 410, a rotating handle 412, a slider 414, pry bars 416a and 416b, and a chain arm hook 417. The interior of the insertion tool 400 is Figure 11 Shown in more detail in .

[0097] The housing 410 includes a tubular shape with an inner cavity that runs through the entire housing. A rotary handle 412 is connected to the rear end of the housing 410 and includes a threaded inner cavity 420 that is connected to the inner cavity of the housing 410. Crowbar 416a and crowbar 416b are both connected to the front end of the housing 410 by a hinge. In certain embodiments, the insertion tool 400 includes a device that maintains the attraction between crowbar 416a and crowbar 416b, such as a magnet, a spring or an elastic band. Slider 414 slides along the side of the housing 410 and includes a chain arm hook 417 at its front end. Wedge rod 418 is positioned in the inner cavity of the housing 410. Wedge rod 418 includes a threaded area (not shown) at its rear end and terminates at a wedge 419 at its front end. Figure 12A and Figure 12BThe wedge rod 418 is depicted being actuated by rotating the handle 412, wherein twisting the handle 412 engages the threaded lumen 420 with the rearward threaded region of the wedge rod 418 to advance the wedge rod 418 in an anterior or posterior direction. In some embodiments, the wedge rod 418 and the slider 414 are attached by a coupler 422 such that movement of the slider 414 is coupled to movement of the wedge rod 418.

[0098] Now refer to Figure 13A and Figure 13B , which depicts the function of the wedge rod 418. The pry bar 416a has been drawn in wireframe to reveal the angled notch 426, which is also present in the pry bar 416b. The combination of the two angled notches 426 provides clearance to accommodate the wedge 419 when in the forward most position. As described above, the wedge rod 418 can be pushed in the forward or rearward direction using the rotating handle 412. Figure 13B 4. In the embodiment of the present invention, the rearward advancement of the wedge rod 418 causes the wedge 419 to slide against the inclined notch 426 to steadily move the pry bar 416a and the pry bar 416b away from each other.

[0099] Now refer to Figure 14 , which details the front end of insertion tool 400. The front ends of pry bars 416a and 416b terminate in tabs 424a and 424b, respectively. Chain arm hook 417 is composed of a series of chain arms extending from the front end of slider 414 and terminating in a hook sized to loop around link 324 of expandable device 300. Figure 15 The front end of the insertion tool 400 is juxtaposed with the expandable device 300 to illustrate the engagement points. As described elsewhere herein, tabs 424a and 424b fit within connectors 318a and 318b to engage the pry bar 424a to the arm 309a and the pry bar 424b to the arm 310a. The link arm hook 417 surrounds the link 324, and a gap 320 is provided on the arm 309a to facilitate access to the link 324.

[0100] Now refer to Figure 16A and Figure 16B , which depicts the insertion tool 400 engaging the expandable device 300 and opening the expandable device 300. Figure 16A, pry bars 416a and 416b of insertion tool 400 are respectively engaged to arms 309a and 310a, and link hook 417 surrounds connecting rod 324 (not visible). To open expandable device 300, while holding housing 410 stationary, rotation handle 412 is twisted, causing wedge rod 418 to advance in a rearward direction within housing 410. The rearward advancement of wedge rod 418 pulls wedge 419 in a rearward direction, separating pry bars 416a and 416b to push arms 309a and 310a apart. Slider 414 is also advanced in a rearward direction by pulling on the slider 414 or by means of coupler 422 that couples the movement of slider 414 to wedge 419. The rearward advancement of slider 414 pulls link hook 417 in a rearward direction, which pulls on connecting rod 324 to facilitate rotation of bolt 312a. The coordinated action of pushing arms 309a and 310b apart and pulling on links 324 creates a synchronized series of movements in which pins 314 are guided by pin guides 326, thereby positioning all pins 314 in the desired position. Figure 7B Insertion tool 400 is shown in open position 330. Insertion tool 400 can be removed by twisting handle 412 in the opposite direction to push wedge rod 418 in a forward direction and clear wedge 419 from angled notch 426, thereby closing pry bars 416a and 416b together and disengaging tabs 424a and 424b from connectors 318a and 318b. Link arm hook 417 can be disengaged from link 324, thereby removing insertion tool 400 from expandable device 300.

[0101] Third expandable device

[0102] Now refer to 17A to 17D , which depicts an exemplary expandable device 500. The expandable device 500 includes four arms (a first upper arm 502a, a second upper arm 502b, a third lower arm 504a, and a fourth lower arm 504b) and four movable bolts 508 (referred to herein as a first rear bolt 508a, a second front bolt 508b, a third rear bolt 508c, and a fourth front bolt 508d). Each arm includes two slots 506 sized to accommodate the movable bolts 508. Each bolt 508 is secured within the slot 506 by a pin 512 secured to each arm. As described elsewhere herein, the bolt 508a is secured to the bolt 508c by a crossbar 510a, and the bolt 508b is secured to the bolt 508d by a crossbar 510b.

[0103] The arms 502a, 502b, 504a, 504b, bolts 508a-508d, and pin 512 are preferably constructed of a rigid material such as a metal or a hard polymer. In various embodiments, the rigid material is a biocompatible material. In certain embodiments, each arm may include a textured surface or a surface at least partially covered with barbs or spikes to improve attachment of the expandable device 500 within the gap, such as barbs 516. In certain embodiments, each arm may terminate in a taper 505 at the front end, wherein the taper 505 facilitates entry of the expandable device 500 into the gap.

[0104] In various embodiments, each arm may include multiple windows 514. Windows 514 can be placed on each arm without compromising the rigidity of expandable device 500. Windows 514 can be filled with any component that cooperates with the function of expandable device 500. For example, in some embodiments, windows 514 can be filled with biomaterial to promote the in-growth of tissue such as bone. In some embodiments, windows 514 can be filled with a therapeutic agent for treating surrounding tissue. In some embodiments, one or more sensors such as temperature sensors, pressure sensors, corrosion sensors, etc. can be inserted into windows 514 to monitor the device and its surrounding environment. In some embodiments, windows 514 can be used to secure expandable device 500 within the gap by accepting screws or cement. Window 514 can also be used to view and monitor the progress of bone growth into the interior of expandable device 500.

[0105] As described elsewhere herein, in some embodiments, the arms may also include features for engaging an insertion tool. For example, the arm 502a may include a connector 520 having a threaded interior sized to fit a locking drill bit 522. The connector 520 includes one or more attachment features 521 to mate with an insertion tool. The attachment features 521 may be, for example, Figure 17C and Figure 17D The notch shown is adapted to fit within the jaws of an insertion tool. Alternatively, the attachment feature 521 can be threaded to threadably engage an engagement tool. The locking bit 522 can be actuated to lock into a bolt 508 (such as bolt 508a), thereby preventing movement in the expandable device 500. As described elsewhere herein, in another example, the arm 502b can include a slot 518 to engage a driver horn of an insertion tool.

[0106] Now refer to 18A to 18D, which depicts bolts 508a-508d and their corresponding crossbars 510a and 510b. Each bolt 508 comprises a cylindrical shape with a top end, a bottom end, and an outer surface. Each bolt 508 includes four pin guides 530 cut into the outer surface. Each pin guide 530 is a curved slot having a closed position 532 near the center of the bolt 508 and an open position 534 near the top and bottom of the bolt 508. The closed position 532 and the open position 534 are positioned at an angle of approximately 60 to 130 degrees apart from each other on the outer surface. The pin guides 530 are arranged on the bolt 508 on the upper and lower halves of the bolt 508 so that a pin 512 can extend through each pin guide 530. Rotating each bolt 508 causes the pin 512 to slide between the closed position 534 and the open position 534 through each pin guide 530. Each bolt 508 also includes a circular cam 536 on its outer surface located midway between the top and bottom ends of each bolt 508. For example, bolt 508a includes cam 536a, bolt 508b includes cam 536b, bolt 508c includes cam 536c, and bolt 508d includes cam 536d.

[0107] Bolts 508a-508d and crossbars 510a and 510b may have any suitable size. In some embodiments, each bolt 508a-508d has the same size. In some embodiments, each bolt 508a-508d has different sizes or a combination of different sizes. For example, bolts 508a and 508b are depicted as having a wider cylindrical shape than bolts 508c and 508d. Bolt 508a is also depicted as having multiple ridges 538 on its outer surface, such as for engaging a locking drill bit 522. In some embodiments, bolt 508 may have bosses 540 or other internal structures that limit the insertion depth of pin 512. In some embodiments, crossbars 510a and 510b may each have the same size, or in some embodiments, may have different sizes. For example, crossbar 510b is depicted as having a generally cylindrical shape, while crossbar 510a is depicted as having an angled bend and window 514.

[0108] Now refer to Figure 19, which depicts the interior of arm 502b. The perimeter of each slot 506 includes a variable-inclination surface on which the cam 536 of each bolt 508 slides as each bolt 508 rotates. For example, the variable-inclination surface includes opposing first cam surfaces 524 and opposing second cam surfaces 526. When the expandable device 500 is in the closed configuration, the opposing first cam surfaces 524 provide clearance for maintaining the cam 536 and the crossbar 510. The opposing second cam surface 526 has a different height than the opposing first cam surface 524. Therefore, when the expandable device 500 is in the open configuration, rotating each bolt 508 positions the cam 536 and crossbar 510 to rest on the opposing second cam surface 526. Visible in each slot 506 is a pin hole 528 that holds the pin 512 in place while the bolt 508 rotates. Although arm 502b is depicted herein, it should be understood that the description of the features of arm 502b applies equally to any arm of expandable device 500, including the description of arms 502a, 504a, and 504b.

[0109] exist 20A to 20C , expandable device 500 is depicted in an open configuration. As described above, rotating each of bolts 508a-508d transitions expandable device 500 between a fully closed position and a fully open position. This transition is achieved through two mechanisms: first, positioning each pin 512 in each pin guide 530 between a closed position 532 and an open position 534; and second, positioning the cam 536 and crossbar 510 between the opposing first cam surface 524 and the opposing second cam surface 526 of each arm 502a, 502b, 504a, and 504b. Thus, the compressive force acting on expandable device 500 in the open configuration is supported by and located between each pin 512 in pin guide 530, each cam surface 524, and the crossbar 510, which presses against the variable slope surface on the perimeter of each slot 506 at each cam surface 524, 526.

[0110] The arrangement of bolts 508a-508d, pin 512, pin guide 530, cam 536, and opposing cam surfaces 524 and 526 synchronizes the simultaneous movement of each arm 502a, 502b, 504a, and 504b. Transforming the expandable device 500 from a closed configuration to an open configuration separates the upper arms 502a and 502b from the lower arms 504a and 504b at the same rate and distance. Transforming the expandable device 500 from a closed configuration to an open configuration also separates the arms 502a and 504a from the arms 502b and 504b. In some embodiments, the arms 502a and 504a separate parallel to the arms 502b and 504b at the same rate and distance. In some embodiments, wherein the crossbars 510a and 510b are of different sizes, the arms 502a and 504a separate at an angle from the arms 502b and 504b.

[0111] The exemplary expandable device 500 is depicted as having a polyhedral shape with four rectangular sides and a parallelogram-shaped top and bottom when closed ( Figure 17A ), and an asymmetrical polyhedral shape with four rectangular sides and substantially trapezoidal top and bottom when it is opened ( Figure 20A ). However, it should be understood that expandable device 500 is not limited to the shape depicted and can have any suitable shape. For example, each of arms 502a, 502b, 504a, and 504b can include a semicircular shape so that expandable device 500 has an overall cylindrical shape with curved sides and a rounded or oval top and bottom.

[0112] In some embodiments, one or more bolts 508 may have pin guides 530 with different open positions 534 (not shown). For example, bolts 508a and 508c may each have pin guides 530 with open positions 534 at a first height, and bolts 508b and 508d may each have pin guides 530 with open positions 534 at a second height, such that upper arms 502a and 502b are separated from lower arms 504a and 504b by a first height at one end and a second height at an opposite end. Thus, in this manner, expandable device 500 can maintain substantially rectangular sides when closed and can have substantially trapezoidal left and right lordotic angles when open. A similar effect can be achieved by having second cam surfaces 526 of different heights in each arm 502a, 502b, 504a, and 504b.

[0113] The expandable device 500 can have any suitable dimensions between its closed configuration and open configuration. For example, in certain embodiments, the expandable device 500 can have a closed length between 30 mm and 30 cm, a closed width between 7 mm and 7 cm, and a closed height between 8 mm and 8 cm. In certain embodiments, the expandable device 500 can have an open length between 20 mm and 20 cm, an open width between 10 mm and 10 cm, and an open height between 10 mm and 10 cm. The surface area and footprint of the expandable device 500 will depend on the length, width, and height, and will vary accordingly between the open configuration and the closed configuration. The surface area of ​​the expandable device 500 will further depend on modifications to the expandable device 500, such as the number of windows 514.

[0114] Third insertion tool for third expandable device

[0115] Now refer to Figure 21 , which depicts an exemplary insertion tool 600. The insertion tool 600 includes a front end 602, a rear end 604, a non-rotating handle 606, a rotating handle 608, a locking sleeve 610, a clamp 612, a deployment driver 614, a driver horn 616, and a stop 618.

[0116] The non-rotating handle 606 has an inner lumen through which the deployment actuator 614 extends. The rotating handle 608 includes an inner lumen and can be rotated about the non-rotating handle 606 to advance the deployment actuator 614 in a posterior and anterior direction. In some embodiments, a torque handle 622 can be attached to the rear end ( Figure 22D ). The torque handle 622 can be constructed of a rigid material and can provide increased leverage to facilitate rotation of the rotation handle 608.

[0117] The clamp 612 extends immovably in a forward direction from the non-rotating handle 606. Figure 22A and Figure 22BAs shown, the clamp 612 is expandable at the front end 604, thereby enabling the front end of the clamp 612 to be engaged to the connector 520 of the expandable device 500. The clamp 612 includes an inner cavity extending from the rear end 602 to the front end 604, wherein the inner cavity of the clamp 612 is aligned with the locking drill bit 522 when engaged with the expandable device 500. The locking sleeve 610 is slidable along the clamp 612 and limits the expansion of the clamp 612 when placed in the forwardmost position. In some embodiments, the locking sleeve 610 includes a pin 611 that is slidable along the upper and lower inclined surfaces 613 of the clamp 612, so that when the locking sleeve 610 is in the rearmost position, the pin 611 is pressed against the upper and lower inclined surfaces 613, thereby forcing the clamp 612 to expand. In some embodiments, a plug can be engaged to secure the locking sleeve 610 in the forwardmost position. The plug can include a screw or a clamp, such as a backstop 618 ( Figure 22C ).

[0118] In some embodiments, a striker cap 620 can be attached to the rear end of the lumen of the jaws 612. The striker cap 620 can be constructed of a shock absorbing material such as rubber or plastic and can receive a hammer blow to drive the engaged expandable device 500 into the subject while protecting the device features at the rear end 604 of the insertion tool 600.

[0119] Now refer to Figure 23A and Figure 23B , which depicts the deployment actuator 614 in greater detail. The deployment actuator 614 includes an actuator horn 616 hingedly connected at its front end. The actuator horn 616 includes a peg 617 sized to fit within a slot 518 of the expandable device 500. The hinged connection allows the actuator horn 616 to adapt to the expansion device 500 while the deployment actuator 614 remains flush with the clamp 612 and locking sleeve 610.

[0120] As described above, the expandable device 500 can be coupled to the front end 604 of the insertion tool 600 by clamping the front end of the clamp 612 around the connector 520. The clamp 612 is secured around the connector 520 by advancing the locking sleeve 610 to its forwardmost position and locking the locking sleeve 610 in place by engaging the stop 618. The deployment actuator 614 can be coupled to the expandable device 500 by inserting the peg 617 of the actuator horn 616 into the slot 518. Now referring to Figure 24 , the rotating handle 608 is rotated around the non-rotating handle 606 to push the deployment actuator 614 in the front direction, whereupon the arm 502b is pushed in the front direction while the arm 502a is held fixed by the clamp 612. 25A to 25D6 shows the expansion of the expandable device 500 using the insertion tool 600. The repositioning of the arm 502b relative to the arm 502a generates a series of synchronized movements described elsewhere herein, thereby transforming the expandable device 500 from the closed configuration to the open configuration. As will be understood by those skilled in the art, the expandable device 500 can be transformed from the open configuration to the closed configuration by reversing the rotation of the rotation handle 608, which pulls the deployment actuator 614 and the arm 502b in a rearward direction.

[0121] Now refer to Figure 26A and Figure 26B The expandable device 500 can be locked in any position between its open configuration and its closed configuration by sliding the locking bit driver 624 into the inner cavity of the clamp 612 to seat the locking bit driver 624 in the locking bit 522. The locking bit driver 624 can be twisted to drive the locking bit 522 into the bolt 508a, thereby locking its rotation and the movement of every other interconnected member. As described elsewhere herein, the bolt 508a can include ridges 538 on its outer surface to enhance the locking grip of the locking bit 522.

[0122] In some embodiments, the deployment actuator 614 can be removed from the insertion tool 600 and replaced with the funnel 626. Figures 27A to 27C As shown, a funnel 626 can be inserted through the lumen of the rotating handle 608 and the non-rotating handle 606 to position the front end of the funnel 626 adjacent to the expandable device 500. The funnel 626 includes a lumen extending from its rear end to its front end, wherein the lumen is aligned with the open gap between the arms of the expansion device 500. The funnel 626 can thereby be used to deposit materials such as bone graft or tissue. The funnel 626 can also be used to accurately guide instruments to the expansion device 500. As described elsewhere herein, the expandable device 500 can include a crossbar 510a having a window 514 to facilitate access to the expansion device 500.

[0123] Fourth expandable device

[0124] Now refer to Figure 28A, which depicts an exemplary expandable device 700. The expandable device 700 includes four arms (a first upper arm 702a, a second upper arm 702b, a third lower arm 704a, and a fourth lower arm 704b) and four movable bolts 708 (referred to herein as a first rear bolt 708a, a second front bolt 708b, a third rear bolt 708c, and a fourth front bolt 708d). Each arm includes two slots 706 sized to accommodate the movable bolts 708. Each bolt 708 is secured within the slot 706 by a pin 712 secured to each arm. As described elsewhere herein, bolt 708a is secured to bolt 708c by a crossbar 710a, and bolt 708b is secured to bolt 708d by a crossbar 710b.

[0125] The arms 702a, 702b, 704a, 704b, bolts 708a-708d, and pin 712 are preferably constructed of a rigid material such as a metal or a hard polymer. In various embodiments, the rigid material is a biocompatible material. In certain embodiments, each arm may include a textured surface or a surface at least partially covered with barbs or spikes to improve attachment of the expandable device 700 within the gap, such as barbs 716. In certain embodiments, each arm may terminate in a taper 705 at the front end, wherein the taper 705 facilitates entry of the expandable device 700 into the gap.

[0126] In various embodiments, each arm may include multiple windows 714. A window 714 may be placed on each arm without compromising the rigidity of the expandable device 700. The windows 714 may be filled with any component that cooperates with the function of the expandable device 700. For example, in some embodiments, the windows 714 may be filled with a biomaterial to promote the ingrowth of tissue such as bone. In some embodiments, the windows 714 may be filled with a therapeutic agent for treating surrounding tissue. In some embodiments, one or more sensors such as temperature sensors, pressure sensors, corrosion sensors, etc. may be inserted into the windows 714 to monitor the device and its surroundings. In some embodiments, the windows 714 may be used to secure the expandable device 700 within the gap by receiving screws or cement. The windows 714 may also be used to view and monitor the progress of bone growth into the interior of the expandable device 700.

[0127] As described elsewhere herein, in some embodiments, the arms may also include features for engaging an insertion tool. For example, arm 702a may include a connector 720 having a threaded hole 721 and a locking bit 722. The locking bit 722 may be actuated to lock into a bolt 708 (such as bolt 708a), thereby preventing movement in the expandable device 700. Figure 30B As can be seen in FIG, crossbar 710b may include a rung 711 that may be pulled or pushed.

[0128] Although not shown in detail, the expandable device 700 uses a system of bolts, crossbars, pins, cams, and cam surfaces similar to those described elsewhere herein to convert the mechanism between the closed and open configurations. In short, the bolts 708a-708d are connected by their respective crossbars 710a and 710b. Each bolt 708 comprises a cylindrical shape with a top, a bottom, and an outer surface. Each bolt 708 includes four pin guides cut into the outer surface. Each pin guide is a curved slot having a closed position near the center of the bolt 708 and an open position near the top and bottom of the bolt 708. The closed and open positions are arranged at an angle of approximately 60 to 130 degrees apart on the outer surface. Pin guides are arranged on the bolt 708 at the upper and lower halves of the bolt 708 so that a pin can extend through each pin guide. Rotating each bolt 708 causes the pin to slide between the closed and open positions through each pin guide. Each bolt 708 also includes a circular cam on an outer surface thereof located midway between the top and bottom ends of each bolt 708 .

[0129] Inside each arm 702a, 702b, 704a, and 704b, the perimeter of each slot 706 includes a variable tilt surface on which the cam of each bolt 708 slides as each bolt 708 is rotated. For example, the variable tilt surface includes opposing first cam surfaces and opposing second cam surfaces. When the expandable device 700 is in the closed configuration, the opposing first cam surfaces provide clearance for maintaining the cam and the crossbar. The opposing second cam surfaces have a different height than the opposing first cam surfaces, so that when the expandable device 700 is in the open configuration, rotating each bolt 708 positions the cam and crossbar to rest on the opposing second cam surfaces.

[0130] Rotating each of bolts 708a-708d transitions expandable device 700 between a fully closed position and a fully open position. This transition is achieved through two mechanisms: first, positioning each pin in each pin guide between the closed and open positions; and second, positioning a cam and crossbar between opposing first and second cam surfaces of each arm 702a, 702b, 704a, and 704b. Thus, the compressive forces acting on expandable device 700 in the open configuration are supported by each pin in the pin guide, as well as each cam surface and crossbar pressing against the variable sloped surface on the perimeter of each slot 706.

[0131] The arrangement of bolts 708a-708d, pins, pin guides, cams, and opposing cam surfaces synchronizes the simultaneous motion of each arm 702a, 702b, 704a, and 704b. Transforming the expandable device 700 from a closed configuration to an open configuration separates the upper arms 702a and 702b from the lower arms 704a and 704b at the same rate and distance. Transforming the expandable device 700 from a closed configuration to an open configuration also separates the arms 702a and 704a from the arms 702b and 704b. In some embodiments, the arms 702a and 704a separate parallel to the arms 702b and 704b at the same rate and distance. In some embodiments, wherein the crossbars 710a and 710b are of different sizes, the arms 702a and 704a separate at an angle from the arms 702b and 704b.

[0132] The exemplary expandable device 700 is depicted as having a polyhedral shape with four rectangular sides and a parallelogram-shaped top and bottom when closed ( Figure 28A ), and having a polyhedral shape with four rectangular sides and rectangular top and bottom when it is opened ( Figure 31E ). However, it should be understood that expandable device 700 is not limited to the shape depicted and can have any suitable shape. For example, each of arms 702a, 702b, 504a, and 504b can include a semicircular shape so that expandable device 700 has an overall cylindrical shape with curved sides and a rounded or oval top and bottom.

[0133] In some embodiments, one or more bolts 708 may have pin guides that have different open positions (not shown). For example, bolt 708a and bolt 708c may each have a pin guide with an open position at a first height, and bolt 708b and bolt 708d may each have a pin guide with an open position at a second height, such that upper arms 702a and 702b are separated from lower arms 704a and 704b by a first height at one end and a second height at an opposite end. In this manner, expandable device 700 can maintain substantially rectangular sides when closed and can have substantially trapezoidal left and right lordotic angles when open. A similar effect can be achieved by having a second cam surface of different heights in each arm 702a, 702b, 704a, and 704b.

[0134] The expandable device 700 can have any suitable dimensions between its closed configuration and open configuration. For example, in certain embodiments, the expandable device 700 can have a closed length between 30 mm and 30 cm, a closed width between 7 mm and 7 cm, and a closed height between 8 mm and 8 cm. In certain embodiments, the expandable device 700 can have an open length between 20 mm and 20 cm, an open width between 10 mm and 10 cm, and an open height between 10 mm and 10 cm. The surface area and footprint of the expandable device 700 will depend on the length, width, and height, and will vary accordingly between the open configuration and the closed configuration. The surface area of ​​the expandable device 700 will further depend on modifications to the expandable device 700, such as the number of windows 714.

[0135] Fourth insertion tool of the fourth expansion device

[0136] Now refer to Figure 28B , which depicts a leading end 802 of an exemplary insertion tool 800. The insertion tool 800 includes at least a shaft 806, a tab 808, a screw 810, and a hole 811 connected to a lumen.

[0137] like Figure 29A and Figure 29B As shown, insertion tool 800 is coupled to expandable device 700 by mating tab 808 with connector 720. This engagement aligns screw 810 with screw hole 721, thereby enabling screw 810 to be screwed into screw hole 721. In some embodiments, shaft 806 includes a lumen extending throughout the shaft that aligns with screw 810, thereby allowing screw 810 to be driven by an extended screwdriver. This engagement also aligns hole 811 with locking drill bit 722, thereby allowing locking drill bit 722 to be driven by an expanded locking drill bit driver.

[0138] Now refer to Figure 30A and Figure 30B , which depicts a deployment rod 812. The deployment rod 812 includes a hook 814 at its front end. The hook 814 is sized to fit over the crosspiece 711 of the expandable device 700. Referring now to Figures 31A to 31E, which sequentially illustrates the expansion of the expandable device 700 using the insertion tool 800. As described above, the expandable device 700 can be coupled to the front end 804 of the insertion tool 800 by engaging the tab 808 with the connector 720 and screwing the screw 810 into the screw hole 721. The deployment rod 812 can be coupled to the expandable device 700 by mounting the hook 814 on the crosspiece 711. The deployment rod 812 is advanced in a rear direction, and then the crosspiece 710b pulls the arm 702b in a rear direction, while the arm 702a is held fixed by the shaft 806. The repositioning of the arm 702b relative to the arm 702a produces a series of synchronized motions described elsewhere herein, thereby transforming the expandable device 700 from a closed configuration to an open configuration.

[0139] Now refer to Figure 32A and Figure 32B , which depicts a push rod 816. The push rod 816 includes a stirrup 818 at its front end. The stirrup 818 is sized to fit within the crosspiece 71 of the expandable device 700. The expandable device 700 can be transformed from the open configuration to the closed configuration by pushing the push rod 816 in a forward direction, which pushes the crossbar 710a and the arm 702b in a forward direction.

[0140] Manufacturing method

[0141] The devices of the present invention may be manufactured using any suitable method known in the art. The method of manufacture may vary depending on the materials used. For example, a device consisting essentially of metal may be milled from a larger block of metal, or may be cast from molten metal. Similarly, a component consisting essentially of plastic or polymer may be milled, cast, or injection molded from a larger block of material. In some embodiments, the devices may be manufactured using 3D printing or other additive manufacturing techniques commonly used in the art.

[0142] How to use

[0143] The present invention also includes methods of using the expandable device. As described elsewhere herein, the expandable device of the present invention can be switched between a compact closed configuration and an expanded open configuration and can withstand compressive forces in the expanded open configuration. The expandable device can be used in any application where it is necessary to maintain a load gap.

[0144] In one embodiment, the expandable device of the present invention is used as an intervertebral fusion device. For example, in the case of a patient who has had a disc removed, the expandable device of the present invention can be used as an intervertebral fusion device to complete a spinal fusion procedure. The rigidity of the expandable device enables stable, long-term maintenance of the intervertebral disc space in an open configuration. The expandable device can also be inserted in a less invasive manner due to its compact closed configuration. In a typical spinal fusion procedure, a skin incision is made near the intervertebral disc to be removed. The intervertebral disc space is identified and the annulus of the intervertebral disc is opened. The intervertebral disc can be extracted from the intervertebral disc space using any suitable tools and techniques, and the adjacent bony endplates can be prepared for bone ingrowth.

[0145] Once the intervertebral disc space has been prepared, the expandable device of the present invention can be used to fuse the spine. Figure 33 , which depicts an exemplary method 900 for inserting an expandable device into a disc space. In step 902, a closed expandable device is filled with bone tissue. In various embodiments, the expandable device may also include one or more components that promote healing, including stem cells, anti-inflammatory drugs, antibiotics, antivirals, etc. In step 904, the expandable device is attached to an insertion tool. In step 906, the expandable device is inserted into the intervertebral space. In step 908, the expandable device is expanded within the intervertebral space using the insertion tool. In step 910, the insertion tool is detached from the expandable device. In optional step 912, the expandable device is further filled with additional bone tissue. During any step, any suitable imaging technique, such as ultrasound or X-ray, may be used to confirm proper placement of the expandable device within the intervertebral space.

[0146] In other embodiments, the expandable devices of the present invention are used as mechanical spacers. For example, in any of a variety of mechanical applications, temporary or permanent support may be required within a gap. As described elsewhere herein, the expandable devices of the present invention may also include one or more sensors for monitoring performance, including temperature sensors, gyroscopes, pressure sensors, corrosion sensors, and the like.

[0147] The disclosures of each patent, patent application, and publication cited herein are incorporated herein by reference in their entirety. Although the present invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of the present 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 interpreted as including all such embodiments and equivalent variations.

Claims

1. An expandable device comprising: (a) a pair of upper arms arranged in parallel with an opposing pair of lower arms, each arm including a front end and a rear end, and each arm of the opposing pair of arms including opposing slots in its front and rear ends; as well as (b) an expansion system comprising bolts, a crossbar and a pin, the bolts being arranged in pairs in parallel, the bolts in each pair being connected by the crossbar, the bolts in each pair being positioned in opposite front and rear slots of the opposing lower and upper arms, respectively, each bolt being secured in a slot by a pin secured to each arm, wherein the expansion system of the bolt, the crossbar and the pin moves the arm between a closed configuration and an open configuration when the bolt is rotated within the slot, and Wherein movement of the arms to the open configuration comprises separating the arms to simultaneously expand the device in each of a height dimension and a width dimension.

2. An expandable device according to claim 1, each bolt includes a pin guide cut into the outer surface of the bolt at each of the top and bottom ends of the bolt, each pin guide including a curved slot having an open position near the end of the bolt and a closed position near the center of the bolt, wherein rotating the bolt causes a pin engaged in the pin guide to slide between the closed position and the open position.

3. An expandable device according to claim 2, wherein the pin guides are arranged in pairs on the upper and lower parts of the bolt.

4. An expandable device according to claim 3, wherein the pin guides are cut into the outer surface of the bolt so that the pin can extend through a pair of opposing pin guides.

5. An expandable device according to claim 1, each bolt includes four pin guides, which are cut into the outer surface of the bolt and arranged in relative pairs at each of the top and bottom ends of the bolt, and each pin guide includes a curved slot having an open position near the end of the bolt and a closed position near the center of the bolt.

6. According to the expandable device according to claim 1, the pin guide on each bolt of a pair of bolts connected at the front end of the arm has an opening position different from the pin guide on the bolt of a pair of bolts connected at the rear end of the arm, so that when the arm is moved to the open configuration, the relative upper arm and the lower arm are separated at different heights at each of their front and rear ends.

7. An expandable device according to claim 1, wherein the cross bar connected by a pair of bolts at the front end of the arm and the cross bar connected by a pair of bolts at the rear end of the arm each have a different length, so that when the arm is moved to an open configuration, the relative upper arm and the lower arm are separated by different widths at each of their front and rear ends.

8. An expandable device according to claim 1, each bolt includes a circular cam on the outer surface located in the middle between the top and bottom ends of the bolt, and the periphery of each slot includes a variable inclination surface, wherein the rotation of the bolt in the slot causes the cam of each bolt to slide along the variable inclination surface of its slot.

9. The expandable device of claim 8, wherein the variable inclination surface comprises opposing first cam surfaces and opposing second cam surfaces, wherein: When the expandable device is in the closed configuration, the relative first cam surface provides a gap for maintaining the cam and the cross bar, wherein the relative second cam surface has a different height than the relative first cam surface, so that when the expandable device is in the open configuration, rotating each bolt positions the cam and the cross bar to rest on the relative second cam surface.

10. An expandable device according to claim 1, wherein the device: (i) has a polyhedral shape with four rectangular sides and a parallelogram top and bottom when in the closed configuration, and has a polyhedral shape with four rectangular sides and a rectangular top and bottom when in the open configuration; or (ii) has an overall cylindrical shape with curved sides and a circular or elliptical top and bottom.

11. The expandable device of claim 1, each of the upper arms comprising a socket or connector at one of its ends.

12. An expandable device comprising: (a) a pair of upper arms arranged in parallel with an opposing pair of lower arms, each arm including a front end and a rear end, and each arm of the opposing pair of arms including opposing slots in its front and rear ends, and each of at least two of the arms including a socket or connector at one of its ends; and (b) A system comprising pairs of bolts arranged in parallel and connected by a crossbar and including pins connecting a pair of connected bolts to opposite front slots and opposite rear slots of the arm, each bolt including a pin guide cut into an outer surface of the bolt at each of the top and bottom ends of the bolt, each pin guide including a curved slot having an open position near the end of the bolt and a closed position near the center of the bolt, wherein rotation of the bolt causes the pin engaged in the pin guide to slide between the closed and open positions, and each bolt includes a circular cam on the outer surface located midway between the top and bottom ends of the bolt, and the periphery of each slot includes a variably inclined surface, wherein rotation of the bolt within the slot causes the cam of each bolt to slide along the variably inclined surface of its slot, wherein said system of said bolt, said crossbar and said pin moves said arm between a closed configuration and an open configuration when said bolt is rotated within said slot, wherein movement of the arms to the open configuration includes separating the arms to simultaneously expand the device in each of a height dimension and a width dimension, and wherein the device has a polyhedral shape with four rectangular sides and a parallelogram top and bottom when in the closed configuration, and wherein the device has a polyhedral shape with four rectangular sides and a rectangular top and bottom when in the open configuration.

13. The expandable device according to claim 12, wherein: The variable tilt surface includes a first relative cam surface and a second relative cam surface, wherein the first relative cam surface provides a gap for maintaining the cam and the cross bar when the expandable device is in the closed configuration, and wherein the second relative cam surface has a different height than the first relative cam surface, so that when the expandable device is in the open configuration, rotating each bolt positions the cam and the cross bar to rest on the second relative cam surface.

14. A combination comprising an expandable device and an insertion tool for deploying the expandable device between adjacent vertebrae, the combination comprising: (a) an expandable device having a polyhedral shape with four rectangular sides and a parallelogram top and bottom when in a closed configuration, and having a polyhedral shape with four rectangular sides and a rectangular top and bottom when in an open expanded configuration, the device comprising a pair of upper arms arranged in parallel with an opposing pair of lower arms, each arm including opposing slots in each of the front and rear ends, the device further comprising a system of bolts, crossbars and pins, the bolts being arranged in parallel as pairs connected by the crossbars, and the pins connecting the bolts to the slots of the arms; (b) an insertion tool comprising a shaft and a pull rod, each of the shaft and the pull rod being connectable to the expandable device, wherein the shaft is connectable to one of the upper arms of the expandable device, Wherein, when in use, the insertion tool is connected to the expandable device to guide the expandable device in the closed configuration into the intervertebral disc space between adjacent vertebrae, and when the shaft holds the connected upper arm in a static position, movement of the pull rod in the front-to-back direction actuates movement of the upper arm not connected to the pull rod and its relative lower arm, thereby causing the implantable device to rotate within the intervertebral disc space, and the insertion tool actuates full expansion of the expandable device by separating the arms to simultaneously expand the device in each of the height and width dimensions.

15. The combination of claim 14 comprising an expandable device and an insertion tool for deploying the expandable device between adjacent vertebrae, the expandable device further comprising a locking device on at least one arm.

16. The combination of claim 14 comprising an expandable device and an insertion tool for deploying the expandable device between adjacent vertebrae, wherein: (i) each of the upper arms of the expandable device includes a slot or connector at its rear end, which respectively cooperates with the shaft and the pull rod of the insertion tool; or (ii) one of the upper arms of the expandable device includes a slot or connector at its rear end, which cooperates with the shaft of the insertion tool, and the rear cross bar connected to the bolt in the opposite rear narrow slot includes a cross piece that cooperates with the pull rod of the insertion tool.

17. An expandable device comprising: first and second upper arms and first and second lower arms, each arm having a front end and a rear end and a top surface and a bottom surface, and each arm having a front slot and a rear slot, wherein the first upper arm is positioned over the first lower arm with the front slot and the rear slot aligned, and the second upper arm is positioned over the second lower arm with the front slot and the rear slot aligned; Four bolts, secured in pairs by links and positioned in aligned front and rear slots in each arm, each bolt secured in each slot by a pin, and each bolt having a pin guide in an outer surface of the bolt near each of the top and bottom ends of the bolt, each pin guide having a closed position near the center of the bolt and an open position near one of the top and bottom ends of the bolt, wherein each pin securing the bolt to the arm is slidably engageable with the pin guide of the bolt.

18. An expandable device according to claim 17, wherein each bolt includes a first pin guide, a second pin guide, a third pin guide and a fourth pin guide, the first pin guide and the second pin guide are positioned relative to each other, each of the first pin guide and the second pin guide extends from between the top end and the bottom end of the bolt and extends toward the top end of the bolt, and the third pin guide and the fourth pin guide are positioned relative to each other, each of the third pin guide and the fourth pin guide extends from between the top end and the bottom end of the bolt and extends toward the bottom end of the bolt.

19. An expandable device according to claim 18, wherein each pin securing a bolt to an arm is slidably engageable with an opposing pin guide of the bolt.

20. An expandable device comprising: a first upper arm and a second upper arm and a first lower arm and a second lower arm, each arm having a front end and a rear end and a top surface and a bottom surface, and each arm having a front slot and a rear slot, wherein the first upper arm is positioned over the first lower arm in a manner that the front slot and the rear slot are aligned, and the second upper arm is positioned over the second lower arm in a manner that the front slot and the rear slot are aligned, and one of the first upper arm and the second upper arm includes a connector or a slot extending from a rear end thereof; Four bolts, secured in pairs by links and positioned in aligned front and rear slots in each arm, each bolt secured in each slot by a pin secured to each arm, each bolt having a pin guide within the outer surface of the bolt located near each of the top and bottom ends of the bolt, each pin guide having a closed position near the center of the bolt and an open position near one of the top and bottom ends of the bolt, each pin guide extending around the outer surface of the bolt with a bend of about 60 degrees to about 130 degrees, wherein each pin securing the bolt to the arm is slidably engageable with the pin guide of the bolt.

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