Device for forming tube in bone marrow cavity

Abstract

Disclosed herein is a device for forming a tube in a medullary cavity of a bone, including a shaft having a proximal end portion and a distal end portion, an actuator configured to be movable relative to the shaft, and a laterally expandable assembly operably coupled to the distal end portion of the shaft. The laterally expandable assembly is configured to transition between retracted and expanded states on a lateral axis perpendicular to a longitudinal axis of the shaft. Wherein movement of the actuator relative to the shaft causes the laterally expandable assembly to transition between a retracted and an expanded state to adjust an outer diameter of the laterally expandable assembly.

Description

[0001] Related applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 431,704, filed on December 11, 2022, the contents of which are incorporated herein by reference in their entirety.

[0003] FIELD AND BACKGROUND OF THE INVENTION

[0004] The present invention, in some embodiments thereof, relates to a device for forming a tube in the medullary cavity of a bone, and more particularly, but not exclusively, to a device having an adjustable diameter for forming a tube in the medullary cavity.

[0005] The continued rapid advancement of medical technology has brought significant advances to a wide range of medical and surgical procedures targeting virtually any organ, system, tissue, and / or cell in the human body.

[0006] One of these rapid advances has been achieved in the field of arthroplasty, which is the surgical replacement of joints, such as the shoulder, hip, knee and / or the like. During this procedure, a damaged joint and / or part of a damaged joint is replaced with an artificial joint prosthesis.

[0007] Artificial joint prostheses can be made of metal, ceramic, high-strength plastic, and / or are designed to look and move like the natural joint it replaces. Summary of the Invention

[0008] According to a first aspect of the present invention, there is provided an apparatus for forming a tube within a medullary cavity, comprising: a shaft having a proximal portion and a distal portion; an actuator configured to be movable relative to the shaft; and a transversely expandable assembly operably coupled to the distal portion of the shaft. The transversely expandable assembly is configured to transition between a retracted state and an expanded state along a transverse axis perpendicular to a longitudinal axis of the shaft, wherein movement of the actuator relative to the shaft causes the transversely expandable assembly to transition between the retracted state and the expanded state to adjust an outer diameter of the transversely expandable assembly.

[0009] According to a second aspect of the present invention, a method for forming a medullary canal in a bone is provided, the method comprising: configuring the outer diameter of a transversely expandable component of a medullary canal forming device to a minimum value, the outer diameter being defined by an actuator that is movable relative to an axis of the device for switching the transversely expandable component between a retracted state and an expanded state; inserting a distal portion of the device into a guide hole created in the medullary cavity of the bone to form a canal in the bone; increasing the outer diameter by expanding the transversely expandable component by moving the actuator relative to the axis; rotating the axis to increase the diameter of the canal; gradually increasing the outer diameter of the canal and rotating the axis to increase the diameter of the canal until a desired diameter is reached; reducing the outer diameter by retracting the transversely expandable component by moving the actuator relative to the axis, and removing the device from the medullary cavity.

[0010] According to a third aspect of the present invention, there is provided a device for forming a tube in the medullary cavity of a bone, the device comprising: a shaft having a proximal portion and a distal portion, a transversely expandable assembly operably coupled to the distal portion of the shaft, the transversely expandable assembly comprising an expandable element; and an actuator configured to expand and contract the expandable element to adjust the outer diameter of the expandable element.

[0011] In further embodiments of the first, second and / or third aspects, the outer diameter is 4 to 20 mm.

[0012] In further embodiments of the first, second and / or third aspects, the laterally expandable assembly is configured to transition between a plurality of discrete stepped states distributed between a retracted state and an expanded state.

[0013] In further embodiments of the first, second and / or third aspects, the laterally expandable assembly is configured to continuously transition between a retracted state and an expanded state.

[0014] In further embodiments of the first, second and / or third aspects, the distal end of the shaft is pointed.

[0015] In an optional embodiment of the first, second and / or third aspects, the device includes a locking element configured to limit movement of the actuator relative to the shaft and prevent changes in expansion and / or retraction of the laterally expandable assembly.

[0016] In an optional embodiment of the first, second and / or third aspects, the device comprises a dial and a pointer, the pointer being mechanically connected to an actuator for indicating the outer diameter.

[0017] In another embodiment of the first aspect and / or the second aspect, the laterally expandable assembly includes a plurality of laterally expandable elements arranged along at least a portion of a shaft and mechanically coupled to the shaft via the actuator. The actuator includes a joint assembly having a plurality of rods, the plurality of rods being tiltable for retracting and expanding the laterally expandable elements.

[0018] In another embodiment of the first and / or second aspects, the joint assembly includes a first joint assembly and a second joint assembly, each of the first joint assembly and the second joint assembly including a plurality of rods. The first joint assembly is fixed along the longitudinal axis of the shaft, and the second joint assembly is movable along the longitudinal axis of the shaft. The inclination of the plurality of rods is proportional to the distance between the first joint assembly and the second joint assembly. The distance can be adjusted by moving the second joint assembly along the longitudinal axis using a knob mounted on the proximal end of the shaft.

[0019] In another embodiment of the first and / or second aspects, the shaft has a threaded outer portion that passes through the threaded hole of the first joint assembly and the threaded hole of the second joint assembly. The threaded shaft is rotatable by a knob, such that rotation of the knob rotates the threaded shaft, thereby moving the movable second joint assembly relative to the fixed first joint assembly along the longitudinal axis of the threaded shaft, and the distance between the first joint assembly and the second joint assembly is adjusted accordingly.

[0020] In further embodiments of the first and / or second aspects, the knob comprises a polygonal socket and / or a polygonal protrusion at a surface opposite to the shaft for attaching a rotating handle.

[0021] In another embodiment of the first aspect and / or the second aspect, the shaft includes an inner shaft, the inner shaft being arranged in a hole of the outer hollow shaft such that the inner shaft extends beyond the outer shaft, the inner shaft being fixed to a fixed section of the knob, and the outer shaft being mechanically coupled to a second section of the knob and movable along the longitudinal axis, and vice versa. The first joint assembly is arranged on the fixed shaft, and the second joint assembly is arranged on the movable shaft, and linear movement of the first section of the knob relative to the second section of the knob causes the inner shaft to move relative to the outer shaft along the longitudinal axis, thereby causing the movable second joint assembly to move relative to the fixed first joint assembly along the longitudinal axis of the shaft, and the distance between the first joint assembly and the second joint assembly is adjusted accordingly.

[0022] In an optional embodiment of the first and / or second aspects, the device comprises one or more spring elements configured to switch between a compressed state and a released state, wherein the tilt of the plurality of rods is proportional to the compression of the one or more spring elements.

[0023] In further embodiments of the first and / or second aspects, the device comprises one or more expandable elements configured to transition between an expanded state and a contracted state. The tilting of the plurality of rods is proportional to the expansion of the one or more expandable elements.

[0024] In an alternative embodiment of the first and / or second aspects, one or more of the plurality of laterally expandable elements are formed to have outwardly curved sides.

[0025] In an alternative embodiment of the first and / or second aspects, one or more of the plurality of laterally expandable elements are shaped to have sharp edges.

[0026] In an optional embodiment of the first and / or second aspects, the transversely expandable assembly includes an annular spring element disposed along at least a portion of the shaft and mechanically coupled to the shaft via the actuator. The actuator includes a joint assembly comprising a first joint assembly fixed along the longitudinal axis of the shaft and a second joint assembly movable along the longitudinal axis of the shaft. The expansion and retraction of the annular spring element are proportional to the distance between the first and second joint assemblies. The distance can be adjusted by moving the second joint assembly along the longitudinal axis via a knob mounted at the proximal end of the shaft.

[0027] In an optional embodiment of the first aspect and / or the second aspect, the laterally expandable assembly includes a plurality of laterally expandable elements, which are arranged along at least a portion of the shaft and are mechanically coupled to the shaft through the actuator, and the actuator includes a conical piston capable of moving along the longitudinal axis of the shaft, for causing the laterally expandable assembly to switch between a retracted state and an expanded state to adjust the outer diameter of the laterally expandable assembly.

[0028] In an alternative embodiment of the first, second and / or third aspects, the medullary canal is formed for insertion of a prosthetic implant.

[0029] In an optional embodiment of the first, second and / or third aspects, the device is used to create a guide hole in the medullary cavity.

[0030] Other systems, methods, features and advantages of the present disclosure will become apparent to those skilled in the art upon review of the following drawings and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the present disclosure, and be protected by the following claims.

[0031] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to the methods and materials described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are still described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, the materials, methods and examples are illustrative only and are not intended to necessarily limit.

[0032] The embodiment of the method and / or system of the embodiment of the present invention can relate to automatically executing or completing selected tasks.In addition, according to the actual instrument and equipment of the embodiment of the method and / or system of the present invention, some selected tasks can be realized by hardware, software or firmware or a combination thereof using an operating system. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Some embodiments of the present invention are described herein by way of example only with reference to the accompanying drawings. With specific reference now to the detailed drawings, it is emphasized that the details are shown by way of example only for the purpose of providing an illustrative discussion of the embodiments of the present invention. In this regard, the description in conjunction with the drawings will enable those skilled in the art to understand how to practice the embodiments of the present invention.

[0034] In the attached figure:

[0035] Figure 1A 、 Figure 1B 、 Figure 1C and Figure 1D are perspective, front, side, top, and bottom views of a first exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in a retracted state and an expanded state;

[0036] Figure 2A 、 Figure 2B and Figure 2C are perspective, front, side, top, and bottom views of a second exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in a retracted state and an expanded state;

[0037] Figure 3A 、 Figure 3B and Figure 3C are perspective, front, side, top, and bottom views of a third exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in a retracted state and an expanded state;

[0038] Figure 4A 、 Figure 4B and Figure 4Care perspective, front, side, top, and bottom views of a fourth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in a retracted state and an expanded state;

[0039] Figure 5A and Figure 5B are perspective, front, side, top, and bottom views of a fifth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in a retracted state and an expanded state;

[0040] Figure 6 shows perspective and side views of an exemplary handle attached to operate a device for forming a tube in an intramedullary cavity having an adjustable diameter in retracted and expanded states according to some embodiments of the present invention;

[0041] Figure 7A 、 Figure 7B and Figure 7C are perspective, front, side, top, and bottom views of a sixth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in a retracted state and an expanded state;

[0042] Figure 8 shows perspective and side views of an exemplary device with an adjustable diameter for forming a tube in a medullary cavity using various tips, according to some embodiments of the present invention; and

[0043] Figure 9 is a flow chart of an exemplary process for forming a tube in a medullary cavity using a device with an adjustable diameter according to some embodiments of the present invention. DETAILED DESCRIPTION

[0044] The present invention, in some embodiments thereof, relates to a device for forming a tube in a medullary cavity, and more particularly, but not exclusively, to a device having an adjustable diameter for forming a tube in a medullary cavity.

[0045] According to some embodiments of the present invention, a device and method for using the same are provided for extracting bone marrow and forming a canal (hereinafter interchangeably referred to as a medullary canal) in the medullary cavity of one or more bones, and extracting bone marrow from the cavity during and / or in preparation for one or more medical and / or surgical procedures. For example, the device can be used to form a medullary canal in a humerus in preparation for a shoulder replacement (e.g., a reverse shoulder replacement, a total shoulder replacement, and / or the like) before implanting a prosthesis.

[0046] In particular, the device can be configured and operated to dynamically adjust the diameter of the segment (portion) of the device inserted into the medullary cavity, so that the device can be used as a single tool to form a medullary canal of a desired diameter and potentially eliminate the need for multiple different tools with different diameters.

[0047] The device may include a shaft having a proximal portion and a distal portion, the distal portion being inserted into the medullary cavity to form the medullary canal. The device may also include an actuator, such as a mechanical actuator, configured to be movable relative to (with respect to) the shaft; and a transversely expandable assembly operably coupled to the distal portion of the shaft, the transversely expandable assembly being configured to transition between a retracted (closed) state and an expanded (open) state along a transverse axis perpendicular to the longitudinal axis of the shaft.

[0048] In particular, movement of the actuator relative to the shaft (e.g., rotational movement, linear movement, lateral movement and / or the like) may cause the transversely expandable component to transition between retracted and expanded states along a transverse axis perpendicular to the longitudinal axis of the shaft, thereby adjusting the diameter, in particular the outer diameter, of the transversely expandable component.

[0049] Operating the device to form a canal in the medullary cavity of the bone can include optionally using the device to insert a distal (guide) portion of the device into a guide hole formed in the medullary cavity. Because the transversely expandable assembly is mechanically coupled to the distal portion of the shaft, which is the portion inserted into the medullary cavity to form the canal, the outer diameter of the transversely expandable assembly can define the diameter of the medullary canal formed in the bone.

[0050] The outer diameter of the laterally expandable assembly, as defined by the extent of expansion of the laterally expandable assembly in the transverse axis, can be adjusted, for example, within a range of 4-20 millimeters (mm), such that when fully retracted, the outer diameter of the laterally expandable assembly can be 4 mm, and when fully expanded, the outer diameter of the laterally expandable assembly can be 20 mm. Clearly, the device can be configured, designed, and / or constructed to facilitate other ranges of outer diameters, such as 5-16 mm, 4-16 mm, 5-20 mm, and / or the like.

[0051] According to some embodiments, the laterally expandable assembly can be configured to transition between a plurality of discrete stepped states distributed between the retracted state and the expanded state, wherein each stepped state corresponds to a respective outer diameter of the laterally expandable assembly. Continuing with the above example, assuming the outer diameter range is configured to be 4-20 mm, the laterally expandable assembly can be configured to transition between 17 stepped states, each step state corresponding to a respective outer diameter, such as 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, and so on, up to 20 mm.

[0052] Alternatively, the laterally expandable assembly can be configured to continuously transition between a retracted state and an expanded state, and thus can be adjusted to have virtually any outer diameter within the expanded range. For example, assuming an outer diameter range of 4-20 mm, the laterally expandable assembly can be configured to have any outer diameter within that range.

[0053] The distal end of the shaft may be configured with a tip that can be used to improve penetration of the shaft into the medullary cavity.

[0054] The actuator can be configured to move and expand and / or retract the laterally expandable assembly while the device (particularly the portion of the device including the laterally expandable assembly) is within the medullary canal, thereby eliminating the need to remove the device from the medullary canal to change the diameter of the device.

[0055] Optionally, the device may further comprise a dial and a pointer mechanically connected to the actuator for indicating the outer diameter. This means that the dial and the pointer may be configured to indicate the outer diameter of the transversely expandable assembly resulting from movement of the actuator relative to the shaft.

[0056] Optionally, the device includes one or more locking elements configured to lock the actuator and limit movement of the actuator relative to the shaft to prevent movement of the laterally expandable assembly, i.e., to prevent retraction and / or expansion of the laterally expandable assembly. Thus, the locking element can ensure that the outer diameter of the laterally expandable assembly does not change when the locking element is locked. The locking element can be released to allow the actuator to move relative to the shaft to expand and / or retract the laterally expandable assembly and adjust the outer diameter of the laterally expandable assembly accordingly.

[0057] Optionally, the transversely expandable element and / or portions thereof may be configured to have outwardly curved edges. Optionally, one or more of the transversely expandable elements may be configured to include one or more elongated slots (e.g., slits, grooves, recesses, holes, etc.) and / or the like. Optionally, one or more edges of the transversely expandable element may be configured to have sharp edges, such as to form razor-like edges.

[0058] An adjustable diameter device for forming a tube in the medullary cavity has important benefits and advantages over currently existing methods and tools for creating and forming a tube in the medullary cavity.

[0059] A particular feature of the present invention is that since the diameter of the adjustable diameter device, particularly the diameter of the portion of the device inserted into the intramedullary cavity, can be dynamically adjusted, the adjustable diameter device can be used as a single tool, which can reduce costs, surgical complexity and maintenance compared to the currently used method of using multiple different tools with different diameters.

[0060] A particular feature of the present invention is that the actuator of the device with adjustable diameter is configured so that when the shaft of the device is inserted into the medullary cavity, the actuator moves relative to the shaft, thereby eliminating the need to remove the device in order to change the diameter of the device, as can be achieved by existing methods, in which each tool with a fixed diameter needs to be removed and replaced with another tool with a larger diameter. Therefore, compared to existing methods, the complexity and / or time (duration) of the medullary canal formation process can be significantly reduced. In addition, compared to existing methods in which tools are inserted into and removed from the medullary cavity multiple times, using a single device and thus reducing the number of times the tool is removed from and inserted into the medullary cavity can reduce the risk of damaging the patient's medullary cavity and / or other bones, muscle tissue and / or other organs.

[0061] A particular feature of the present invention is that an adjustable diameter device can optionally be used to create an initial guide hole in the bone for inserting the device's shaft into the medullary cavity. This can further reduce the number of tools required for the procedure because the use of an adjustable diameter device can eliminate the need for specialized tools for creating the guide hole, as may be required with prior art methods.

[0062] A particular feature of the present invention is that the one or more curved and / or razor-like edges of the transversely expandable element can significantly enhance its ability and / or capacity to extract bone marrow and effectively form a medullary canal within the medullary cavity.

[0063] A particular feature of the present invention is that the laterally expandable element can be configured to be outwardly curved, include one or more elongated slots and / or grooves, and / or be shaped to have sharp edges, which are configured to further enhance its ability and / or capacity to extract bone marrow and effectively form a medullary canal within the medullary cavity.

[0064] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or shown in the accompanying drawings and / or examples. The present invention is capable of other embodiments or can be practiced or carried out in various ways.

[0065] Various aspects of the present invention are described herein with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It should be understood that each block of the flowcharts and / or block diagrams, and combinations of blocks in the flowcharts and / or block diagrams, may be implemented by computer-readable program instructions.

[0066] The flowcharts and block diagrams in the figures illustrate the architecture, functions and operations of possible implementations of the systems, methods and computer program products according to various embodiments of the present invention. In this regard, each box in the flowchart or block diagram may represent a module, segment or portion of an instruction, which includes one or more executable instructions for implementing a specific logical function. In some alternative embodiments, the functions described in the boxes may not be performed in the order shown in the figures. For example, depending on the functions involved, two boxes shown in succession may actually be executed substantially simultaneously, or the boxes may sometimes be executed in the opposite order. It will also be noted that each box in the block diagram and / or flowchart, and the combination of boxes in the block diagram and / or flowchart, may be implemented by a system based on dedicated hardware that performs a specific function or action, or a combination of dedicated hardware and computer instructions.

[0067] Now referring to the accompanying drawings, Figure 1A 、 Figure 1B 、 Figure 1C and Figure 1D 1. A perspective, front, side, top, and bottom views of a first exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in retracted and expanded states.

[0068] An exemplary apparatus 100A configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft 102A, an actuator 106A, and a laterally expandable assembly comprising a plurality of laterally expandable elements 104A, such as four elements operably coupled to the shaft 102A, specifically, to a distal portion of the shaft 102A configured for insertion into the medullary cavity during a tube forming procedure.

[0069] In particular, a plurality of laterally expandable elements 104A can be arranged along at least a portion of the shaft 102A, for example, at a distal portion of the shaft, and mechanically coupled to the shaft 102A via the actuator 106A, which can include a joint assembly, specifically, a first joint assembly 106A1 and a second joint assembly 106A2. Each of the joint assemblies 106A1 and 106A2 can include a plurality of rods 120A that are tiltable for retracting and expanding the laterally expandable elements 104A.

[0070] The actuator 106A may be configured to be movable relative to the shaft 102 by configuring the first joint assembly 106A1 to be fixed (fixed) along the longitudinal axis of the shaft 102A while configuring the second joint assembly 106A2 to be movable along the longitudinal axis of the shaft 102A.

[0071] In this way, when the second joint component 106A2 moves, the distance between the first joint component 106A1 and the second joint component 106A2 changes. For example, when the second joint component 106A2 moves toward the first joint component 106A1, the distance decreases, and when the second joint component 106A2 moves away from the first joint component 106A1, the distance increases.

[0072] The plurality of tiltable rods 120A connect the laterally expandable element 104A to the shaft 102A via hinges, allowing the rods 120A to tilt and thereby expand or retract the laterally expandable element 104A. Obviously, since the rods 120A are connected to the fixed first joint assembly 106A1 and the movable second joint assembly 106A2 on one side and to the laterally expandable element 104A on the other side, the tilt of the plurality of rods 120A is proportional to the distance between the first joint assembly 106A1 and the second joint assembly 106A2.

[0073] Thus, movement of the actuator 106A, and in particular, movement of the second joint assembly 106A2, can cause the laterally expandable element 104A to transition between a retracted and an expanded state. The expansion and retraction of the laterally expandable element 104A can define a diameter of the laterally expandable element 104A, and in particular, an outer diameter 130 between opposing edges of the laterally expandable element 104A. As can be seen, in the fully retracted state, the outer diameter 130 between opposing edges of the laterally expandable element 104A can be a minimum outer diameter 130A, while in the fully expanded state, the outer diameter 130 between opposing edges of the laterally expandable element 104A can be a maximum outer diameter 130B.

[0074] The movement of the second joint assembly 106A2 can be controlled to position the laterally expandable element 104A in a plurality of expanded states between a fully retracted state and a fully expanded state, which can correspondingly limit the outer diameter 130 to a range between a minimum outer diameter 130A and a maximum outer diameter 130B. The device 100A can be configured such that the outer diameter 130 can be within one or more ranges. For example, the device 100A can be configured such that the outer diameter 130 is within a range of 4 mm to 20 mm, such that the minimum outer diameter 130A is 4 mm and the maximum outer diameter 130B is 20 mm. In another example, the device 100A can be configured such that the outer diameter 130 is within a range of 7 mm to 16 mm, such that the minimum outer diameter 130A is 7 mm and the maximum outer diameter 130B is 16 mm.

[0075] The actuator 106A can be used and / or operated in one or more ways to move the movable second joint assembly 106A2 along the longitudinal axis of the shaft 102A, thereby changing the distance between the first joint assembly 106A1 and the second joint assembly 106A2. For example, the actuator 106A can be operated by a knob 108A mounted on the proximal end of the shaft 102A.

[0076] For example, the shaft 102A can be configured to have a threaded exterior that passes through a threaded hole in the first joint assembly 106A1 and a threaded hole in the second joint assembly 106A2. The threaded shaft 106A is rotatable by a knob 108A, such that rotation of the knob 108A rotates the threaded shaft 106A. Due to the rotation of the threaded shaft 102A, the movable second joint assembly 106A2 can move along the longitudinal axis of the threaded shaft 102A relative to the fixed first joint assembly 106A1, and the distance between the second joint assembly 106A2 and the first joint assembly 106A1 is adjusted accordingly. For example, rotating the knob 108A in one direction (e.g., clockwise) can rotate the threaded shaft 106A clockwise and pull the second joint assembly 106A2, which can include, for example, a floating nut 106A3, so that the second joint assembly 106A2 moves toward the fixed first joint assembly 106A1. In another example, rotating the knob 108A in another direction (eg, counterclockwise) may cause the threaded shaft 106A to rotate counterclockwise and push the second joint component 106A2 , causing the second joint component 106A2 to move away from the fixed first joint component 106A1 .

[0077] In such an embodiment, the knob 108A may include a polygonal socket (recess) 110A and / or a polygonal protrusion on a surface opposite the shaft 102A for connecting a manually and / or electrically or hydraulically driven handle (power tool), such as a wrench, ratchet, Allen key, hexagonal wrench, Torx key, and / or similar tool configured to rotate the knob 108A. The polygonal socket 110A and / or protrusion may take one or more forms and / or structures, such as a triangle, square, hexagon, Torx, and / or similar shapes and / or structures.

[0078] In another example, a shaft such as shaft 102A can include an inner shaft disposed within a bore of an outer hollow shaft such that the inner shaft extends beyond the outer shaft. The inner shaft can be fixed to a first (fixed) section of a knob 108A, while the outer shaft can be mechanically coupled to a second section of a knob (e.g., knob 108A), the second section being separate from the first section such that the outer shaft can move relative to the inner shaft, particularly relative to the inner shaft along the longitudinal axis of the shaft 102. In this case, a fixed first joint assembly 106A1 can be mechanically coupled to the inner shaft of the shaft 102A, while a movable second joint assembly 106A2 can be mechanically coupled to the outer shaft of the shaft 102A.

[0079] The knob 108A can be configured to convert linear motion, force, and / or pressure on its top surface opposite the shaft 102A into movement of the outer shaft relative to the inner shaft. Thus, applying linear motion, force, and / or pressure in one direction (e.g., downward) can cause the second joint component 106A2 coupled to the moving outer shaft to move toward the first joint component 106A1 coupled to the stationary inner shaft. Complementarily, applying linear motion, force, and / or pressure to the knob in the other direction (e.g., upward) can cause the second joint component 106A2 to move away from the first joint component 106A1.

[0080] Alternatively, the inner shaft can be movable and the outer shaft can be fixed. In this case, the same design can be applied except that the fixed first joint assembly 106A1 can be operatively coupled to the outer shaft of the shaft 102A and the movable second joint assembly 106A2 can be mechanically coupled to the inner shaft of the shaft 102A.

[0081] The device 100A may further include one or more locking elements 112A configured to lock the actuator 106A, and in particular, the second joint assembly 106A2, and restrict its movement relative to the shaft 102A to prevent movement of the laterally expandable element 104A, i.e., to prevent the laterally expandable element from retracting or expanding. The locking elements may be released to allow the second joint assembly 106A2 to move relative to the shaft 102A to expand and / or retract the laterally expandable element 104A and adjust the outer diameter 130 accordingly.

[0082] Thus, when one or more locking elements 112A are in their released states, the device 100A can be operated to move the actuator 106A, and in particular the second joint assembly 106A2, relative to the shaft 102A to a specific position to set the desired outer diameter 130 of the laterally expandable element 104A. Once the second joint assembly 106A2 is in the specific position, the one or more locking elements 112A can be switched to their locked states to secure the second joint assembly 106A2 from movement, thereby locking the laterally expandable element 104A in place and preventing its outer diameter 130 from changing.

[0083] One or more locking elements 112A can be configured and / or designed to lock and release the movement of the actuator 106A, particularly the movement of the second joint assembly 106A2. For example, one or more locking elements 112A can be connected to the shaft 102A via one or more hinges, allowing them to move along a transverse axis relative to the shaft 102A and the second joint assembly 106A2. One or more locking elements 112A can be configured to have a pointed distal tip that is configured to engage each of a plurality of recesses and / or slots embedded in the second joint assembly 106A2. Thus, pushing the proximal end of one or more locking elements 112A outward (i.e., away from the knob 108A) can cause the pointed distal end of one or more locking elements 112A to enter one of the slots of the second joint assembly 106A2 and prevent rotation and / or linear movement thereof, thereby preventing movement relative to the shaft 102A.

[0084] Utilizing one or more locking elements 112A, in addition to using the knob 108A to operate the actuator 106A (particularly to move the second joint assembly 106A2 to expand or retract the laterally expandable element 104A and adjust its outer diameter 130 accordingly), the knob 108A can also be used to rotate the shaft 102A and the laterally expandable element 104A, for example, when the shaft 102A and the laterally expandable element 104A are inserted into the intramedullary cavity to form the medullary canal.

[0085] In these embodiments, when one or more locking elements 112A are released, rotating the knob 108A can expand or retract the laterally expandable element 104A and accordingly adjust its outer diameter 130. However, when one or more locking elements 112A are locked, rotating the knob 108A can rotate the device 100A, and in particular, the shaft 102A and the laterally expandable element 104A.

[0086] Optionally, the device 100A may include a dial 114A and a pointer 115A indicating the outer diameter 130 of the laterally expandable element 104A. The dial 114A may include one or more markings, numbers, and / or symbols indicating the outer diameter 130. For example, the dial 114A may include a plurality of numbers representing a range of the outer diameter 130 in millimeters, such as 7 mm to 16 mm. The pointer 115A may point to one of the numbers corresponding to the current outer diameter 130 of the laterally expandable element 104A. To illustrate the symbols (in this example, the numbers on the dial 114A), for example, the number 15 corresponding to an outer diameter 130 of 15 mm is labeled with reference numeral 114A1. However, to avoid clutter and maintain readability of the drawings, the other symbols (numbers) on the dial 114A are not associated with the reference numerals.

[0087] The dial 114A and pointer 115A can be implemented using one or more techniques and / or designs. For example, because the outer diameter 130 of the laterally expandable element 104A can be derived from the position of the actuator 106A, and in particular, the position of the second joint assembly 106A2 on the longitudinal axis of the shaft 102A, the pointer 115A can be mechanically coupled to the second joint assembly 106A2 so that it can indicate the movement of the second joint assembly 106A2. In this way, the position of the pointer 115A relative to the dial 114A can change based on the movement of the second joint assembly 106A2 and point to a marking, such as a number, corresponding to the outer diameter 130 of the laterally expandable element 104A defined by the position of the second joint assembly 106A2.

[0088] Optionally, the pointer 115A may be integrated into one or more locking elements 112A, which may also be coupled to the second joint assembly 106A2 to restrict its movement relative to the shaft 102A along the longitudinal axis of the shaft 102A.

[0089] It should be noted that although the first joint assembly 106A1 is fixed and the second joint assembly 106A2 is movable in the description of the device 100A, this should not be construed as limiting, as it will be apparent to those skilled in the art that the roles of the first joint assembly 106A1 and the second joint assembly 106A2 can be reversed, such that the second joint assembly 106A2 is fixed and the first joint assembly 106A1 is movable. In addition, other configurations can be designed in which the first joint assembly 106A1 and the second joint assembly 106A2 are movable relative to each other.

[0090] Optionally, one or more of the laterally expandable elements 104A may be shaped with outwardly curved sides, such as L-shaped sides and / or the like, to improve bone marrow extraction and medullary canal formation when the laterally expandable element 104A is rotated within the medullary cavity.

[0091] Optionally, one or more of the laterally expandable elements 104A may be shaped with sharp edges to further improve bone marrow extraction and medullary canal formation when the laterally expandable element 104A is rotated within the medullary cavity.

[0092] Now refer to Figure 2A 、 Figure 2B and Figure 2C , which are perspective, front, side, top and bottom views of a second exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in a retracted state and an expanded state.

[0093] An exemplary apparatus 100B configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft 102B, an actuator 106B, and a laterally expandable assembly comprising a plurality of laterally expandable elements 104B, such as two elements operably coupled to the shaft 102B, specifically, coupled to a distal portion of the shaft 102B configured for insertion into the medullary cavity during a tube forming procedure.

[0094] The construction of the device 100B, its operation and structural elements are very similar to those of the device 100A described previously herein.

[0095] Specifically, similar to actuator 106A, actuator 106B may include a joint assembly, specifically, a first joint assembly 106B1 fixed relative to shaft 102B along the longitudinal axis of shaft 102B and a second joint assembly 106B2 movable along the longitudinal axis. Each of joint assemblies 106B1 and 106B2 may include a plurality of rods 120B that are tiltable for retracting and extending the laterally expandable element.

[0096] As described for device 100A, the expansion and retraction of the laterally expandable element 104B can limit the outer diameter 130 of the laterally expandable element 104B, that is, the distance between the sides of the opposite laterally expandable components 104B, wherein the expansion and retraction of the laterally expandable element 104B is limited by the degree of inclination of the rod 120B, which in turn depends on the distance between the movable second joint component 106B2 and the fixed first joint component 106B1.

[0097] As described for device 100A, the movement of the actuator 106B, in particular the movement of the second joint assembly 106B2, can cause the laterally expandable element 104B to transition between a fully retracted state and a fully expanded state (including the fully retracted state and the fully expanded state), thereby correspondingly limiting the outer diameter 130 between the edges of the relative laterally expandable element 104B to a range between the minimum outer diameter 130A in the fully retracted state and the maximum outer diameter 130B in the fully expanded state.

[0098] Similar to device 100A, the movement of second joint assembly 106B2 to set its distance from first joint assembly 106B1 can be controlled by rotational and / or linear movement of knob 108B, such as knob 108A. For example, in the case of threaded shaft 102A, the movement of second joint assembly 106B2 can be controlled by floating nut 106B3, such as floating nut 106A3. In addition, in these embodiments, knob 108B may include a polygonal socket (recess) 110B and / or a polygonal protrusion on a surface opposite shaft 102B for connecting a manual and / or power handle (power tool) configured to rotate knob 108B.

[0099] Optionally, the device 100B may include one or more locking elements 112B (such as locking element 112A) for locking the position of the movable second joint assembly 106B2 to maintain the currently set outer diameter 130 of the laterally expandable element 104B.

[0100] Optionally, the device 100B may include a dial 114B (e.g., dial 114A) and an indicator 115B indicating the outer diameter 130 of the laterally extendable element 104B. To illustrate the symbols (in this example, the numbers on the dial 114B), the number 11 corresponding to an outer diameter 130 of 11 mm is indicated by reference numeral 114B1. However, to avoid clutter and maintain the readability of the drawings, the other symbols (numbers) on the dial 114B are not associated with the reference numerals. The device 100B may employ one or more structures, configurations, and / or designs for implementing the dial 114B and the indicator 115B that are similar to those used for the dial 104A and its indicator 115B. For example, the indicator 115B may be integrated with one or more of the locking elements 112B.

[0101] As described with respect to device 100A, although in the description of device 100B, the first joint component 106B1 is fixed and the second joint component 106B2 is movable, this should not be construed as limiting, as it is apparent to those skilled in the art that the roles of the first joint component 106B1 and the second joint component 106B2 can be reversed, such that the second joint component 106B2 is fixed and the first joint component 106B1 is movable. In addition, other structures can be designed in which the first joint component 106B1 and the second joint component 106B2 are movable relative to each other.

[0102] Optionally, one or more of the laterally expandable elements 104B may be shaped with outwardly curved sides, such as L-shaped sides and / or the like, to improve bone marrow extraction and medullary canal formation when the laterally expandable element 104B is rotated within the medullary cavity.

[0103] Optionally, one or more of the transversely expandable elements 104B can be configured to have sharp edges to further improve bone marrow extraction and medullary canal formation when the transversely expandable element 104B is rotated within the medullary cavity. For example, one or more of the transversely expandable elements 104B can be configured and shaped to include one or more elongated slots 122B, such as slits, depressions, recesses, holes, grooves, and / or the like. In this way, when the transversely expandable element 104B is rotated within the medullary cavity, the slots 122B can efficiently and smoothly cut the bone marrow, thereby improving bone marrow extraction and medullary canal formation.

[0104] Now refer to Figure 3A 、 Figure 3B and Figure 3C , which are perspective, front, side, top and bottom views of a third exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in a retracted state and an expanded state.

[0105] An exemplary apparatus 100C configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft 102C, an actuator 106C, and a laterally expandable assembly comprising a plurality of laterally expandable elements 104C, such as two elements operably coupled to the shaft 102C, specifically, to a distal portion of the shaft 102C configured for insertion into the medullary cavity during a tube forming procedure.

[0106] The construction of the device 100C, its operation and structural elements are very similar to those of the devices 100A and 100B described previously herein.

[0107] Specifically, similar to actuator 106A, actuator 106C may include a joint assembly, specifically, a first joint assembly 106C1 fixed relative to shaft 102B along the longitudinal axis of shaft 102C and a second joint assembly 106C2 movable along the longitudinal axis. In this embodiment, the transversely expandable element 104C is formed by a plurality of rods 120C that are tiltable to thereby retract and expand the transversely expandable element 104C.

[0108] As described for device 100A, the expansion and retraction of the laterally expandable element 104C can limit the outer diameter 130 of the laterally expandable element 104C, that is, the distance between the sides of the opposite laterally expandable components 104C, wherein the expansion and retraction of the laterally expandable element 104B is limited by the degree of inclination of the rod 120C (that is, the degree of inclination of the rod 120C of the laterally expandable element 104C), and the degree of inclination of the rod 120C depends on the distance between the movable second joint component 106C2 and the fixed first joint component 106C1.

[0109] As described for device 100A, the movement of the actuator 106C, in particular the movement of the second joint assembly 106C2, can cause the laterally expandable element 104C to transition between a fully retracted state and a fully expanded state (including the fully retracted state and the fully expanded state), thereby correspondingly limiting the outer diameter 130 between the edges of the relative laterally expandable elements 104B to a range between the minimum outer diameter 130A in the fully retracted state and the maximum outer diameter 130B in the fully expanded state.

[0110] Similar to device 100A, the movement of second joint assembly 106C2 to set its distance from first joint assembly 106C1 can be controlled by rotation and / or linear movement of knob 108C, such as knob 108A. For example, in the case of threaded shaft 102C, the movement of second joint assembly 106C2 can be controlled by floating nut 106C3, such as floating nut 106A3. In addition, in these embodiments, knob 108B may include a polygonal socket (recess) 110C and / or a polygonal protrusion on a surface opposite shaft 102C for connecting a manual and / or power handle (power tool) configured to rotate knob 108C.

[0111] Optionally, the device 100C may include one or more locking elements 112C (such as locking element 112A) for locking the position of the movable second joint assembly 106C2 to maintain the currently set outer diameter 130 of the laterally expandable element 104C.

[0112] Optionally, the device 100C may include a dial 114C (such as dial 114A) and an indicator 115C that indicates the outer diameter 130 of the laterally extendable element 104C. To illustrate the symbols (in this example, the numbers on the dial 114C), the number 9 corresponding to the outer diameter 130 of 9 mm is indicated by reference numeral 114C1. However, to avoid clutter and maintain the readability of the drawings, the other symbols (numbers) on the dial 114C are not associated with the reference numerals. The device 100C may employ one or more structures, configurations, and / or designs for implementing the dial 114C and indicator 115C that are similar to those used for the dial 104A and its indicator 115C. For example, the indicator 115C may be integrated with one or more of the locking elements 112C.

[0113] As described with respect to apparatus 100C, although the first joint assembly 106C1 is described as being fixed and the second joint assembly 106C2 as being movable, this should not be construed as limiting, as it will be apparent to those skilled in the art that the roles of the first and second joint assemblies 106C1 and 106C2 can be reversed, such that the second joint assembly 106C2 is fixed and the first joint assembly 106C1 is movable. Furthermore, other configurations can be devised in which the first joint assembly 106C1 and the second joint assembly 106C2 are movable relative to each other.

[0114] Optionally, one or more of the laterally expandable elements 104C may be formed with outwardly curved sides, such as L-shaped sides and / or the like, to improve bone marrow extraction and medullary canal formation when the laterally expandable element 104C is rotated within the medullary cavity.

[0115] Optionally, one or more of the laterally expandable elements 104C may be shaped with sharp edges to further improve bone marrow extraction and medullary canal formation when the laterally expandable element 104C is rotated within the medullary cavity.

[0116] In another example, a device such as devices 100A, 100B, and / or 100C (collectively, device 100) can employ one or more spring elements configured to transition between a compressed state and a released state, wherein the inclination of a plurality of rods (e.g., rods 120A, 120B, and / or 120C) is proportional to the compression of the spring elements.

[0117] For example, a device 100 comprising a plurality of laterally expandable elements (e.g., laterally expandable element 104A of device 100A) may include an actuator 106 comprising one or more spring elements disposed at one or more locations along a distal portion of a shaft (e.g., shaft 102A), e.g., below a first joint element (e.g., first joint assembly 106A1) and below a second joint assembly (e.g., second joint assembly 106A2). The spring elements may be operable to transition between compressed and released states by a knob (e.g., knob 108A), which may be operably coupled to the spring elements, e.g., by a rotatable metal cord configured to compress or retract the spring elements when rotated.

[0118] In another example, a device such as devices 100A, 100B, and / or 100C (collectively, device 100) may employ one or more expandable elements configured to transition between expanded and contracted states. The inclination of multiple rods (such as rods 120A, 120B, and / or 120C) is proportional to the expansion of one or more spring elements.

[0119] For example, a device 100 configured with multiple laterally expandable elements (e.g., laterally expandable element 104B of device 100B) can include an actuator 106 comprising one or more expandable elements disposed at one or more locations along a distal portion of a shaft (e.g., shaft 102B), e.g., below a first joint element (e.g., first joint assembly 106B1) and below a second joint assembly (e.g., second joint assembly 106B2). The expandable elements can be operated to transition between an expanded state and a contracted state by a knob (e.g., knob 108B), which can be operably coupled to a spring element, e.g., via a pressure tube configured to pump a fluid (e.g., liquid, gas (e.g., air), and / or the like) into the expandable elements or release air from the expandable elements, thereby respectively expanding and contracting the expandable elements. Additionally, device 100 can also include a pump configured to push a fluid into the expandable elements or release a fluid from the expandable elements, e.g., a manual pump, an electric pump, and / or the like.

[0120] Now refer to Figure 4A 、 Figure 4B and Figure 4C , which are stereoscopic, front, side, top and bottom views of a fourth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in a retracted state and an expanded state.

[0121] An exemplary apparatus 100D configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft 102D, an actuator 106D, and a laterally expandable assembly including an annular spring element 104D operably coupled to the shaft 102D, specifically, to a distal portion of the shaft 102C configured for insertion into the medullary cavity during a tube forming procedure.

[0122] The actuator 106D may include a joint assembly, specifically, a first joint assembly 106D1 fixed relative to the shaft 102D along the longitudinal axis of the shaft 102D and a second joint assembly 106D2 movable along the longitudinal axis of the shaft 102D.

[0123] The annular spring element 104D can transition between a retracted state and an expanded state based on the distance between the movable second joint component 106D2 and the fixed first joint component 106D1. The degree of expansion of the annular spring element 104D can define an outer diameter 130 of the annular spring element 104.

[0124] As can be seen, movement of the actuator 106D, and in particular movement of the second joint assembly 106D2, can compress and / or release the annular spring element 104D along a transverse axis perpendicular to the longitudinal axis of the shaft 102D. Thus, movement of the second joint assembly 106D2 can cause the annular spring element 104D to transition between (and including) a fully retracted state and a fully expanded state, thereby correspondingly confining the outer diameter 130 to a range between a minimum outer diameter 130A in the fully retracted state and a maximum outer diameter 130B in the fully expanded state.

[0125] Furthermore, when transitioning to the expanded state, the annular spring element 104D can assume an at least slightly conical shape through movement of the actuator 106D, wherein the annular spring element 104D can be narrower at the distal end of the shaft 102 and wider at the proximal end of the shaft 102D. This is because the annular spring element 104D is fixedly coupled to the distal end of the shaft 102D (via the first joint assembly 106D1) and thus expands more at the proximal end of the shaft 102D than at the distal end of the shaft 102D. The conical shape of the annular spring element 104D can improve penetration of the device 100 into the intramedullary cavity.

[0126] Similar to device 100A, the movement of second joint assembly 106D2 to set its distance from first joint assembly 106C1 can be controlled by rotation and / or linear movement of knob 108D, such as knob 108A. For example, in the case of threaded shaft 102D, the movement of second joint assembly 106D2 can be controlled by floating nut 106D3, such as floating nut 106A3. In addition, in these embodiments, knob 108D may include a polygonal socket (recess) 110D and / or a polygonal protrusion on a surface opposite shaft 102D for attachment of a manual and / or power handle (power tool) configured to rotate knob 108D.

[0127] Optionally, the device 100D may include one or more locking elements 112D (such as locking element 112A) for locking the position of the movable second joint assembly 106D2 to maintain the currently set outer diameter 130 of the annular spring element 104D.

[0128] Optionally, the device 100D may include a dial 114D (such as dial 114A) and a pointer 115D indicating the outer diameter 130 of the annular spring element 104D. To clarify the symbols (in this example, the numbers of the dial 114D), the number 13 corresponding to the outer diameter 130 of 13 mm is indicated by reference numeral 114D1. However, to avoid clutter and maintain the readability of the drawings, the other symbols (numbers) of the dial 114D are not associated with the reference numerals. The device 100D may employ one or more structures, configurations, and / or designs for implementing the dial 114D and pointer 115D that are similar to those used for the dial 104A and its pointer 115A. For example, the pointer 115D may be integrated with one or more of the locking elements 112D.

[0129] As described with respect to apparatus 100C, although the first joint assembly 106D1 is described as being fixed and the second joint assembly 106D2 as being movable, this should not be construed as limiting, as it will be apparent to those skilled in the art that the roles of the first and second joint assemblies 106D1 and 106D2 can be reversed, such that the second joint assembly 106D2 is fixed and the first joint assembly 106D1 is movable. Furthermore, other configurations can be devised in which the first joint assembly 106D1 and the second joint assembly 106D2 are movable relative to each other.

[0130] Optionally, one or more segments of the annular spring element 104D may be shaped with outwardly curved sides, such as L-shaped sides and / or the like, to improve bone marrow extraction and medullary canal formation when the segments of the annular spring element 104D are rotated within the medullary cavity.

[0131] Optionally, one or more segments of the annular spring element 104D may be shaped with sharp edges to further improve bone marrow extraction and medullary canal formation when the segments of the annular spring element 104D are rotated within the medullary cavity.

[0132] Figure 5A and Figure 5B 1 and 2 are perspective, front, side, top, and bottom views of a fifth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention, in retracted and expanded states.

[0133] An exemplary apparatus 100E configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft (not visible in the figures), an actuator 106E, and a laterally expandable assembly comprising a plurality of laterally expandable elements 104E, such as four elements disposed at least partially along the shaft, such as at a distal end portion of the shaft, the distal end portion of the shaft being configured for insertion into the medullary cavity during a tube forming procedure.

[0134] In particular, the plurality of transversely expandable elements 104E may be operatively coupled to the shaft via an actuator 106E, which may include a tapered piston 106E2 movable relative to the shaft, particularly along the longitudinal axis of the shaft, and a joint assembly 106E1 mechanically coupling distal ends of the transversely expandable elements 104A to the shaft. At their proximal ends, the transversely expandable elements 104E may be mechanically coupled to the tapered piston.

[0135] A tapered piston 106E2 configured to be movable along the longitudinal axis of the shaft can cause the laterally expandable element 104E to transition between a retracted state and an expanded state to adjust the outer diameter 130 of the laterally expandable element 104E.

[0136] Thus, when the tapered piston 106E2 moves distally, i.e., downwardly toward the joint assembly 106E1, the plurality of laterally expandable elements 104E can be pushed laterally, thereby increasing their outer diameters 130. Conversely, when the tapered piston 106E2 moves proximally, i.e., upwardly away from the joint assembly 106E1, the plurality of laterally expandable elements 104E can be pulled inwardly, thereby decreasing their outer diameters 130.

[0137] The tapered piston 106E2 can be moved to set the laterally expandable element 104E to a plurality of expansion states (including the fully retracted state and the fully expanded state) between the fully retracted state and the fully expanded state, which can correspondingly limit the outer diameter 130 to a range between the minimum outer diameter 130A and the maximum outer diameter 130B.

[0138] The actuator 106E, specifically the tapered piston 106E2, can be integrated with a knob 108E, and the tapered piston 106E2 can be operated by the knob 108E. For example, one or more striking elements and / or pushing elements can be used to push the tapered piston 106E2 toward the joint assembly 106E1 and / or to pull the tapered piston 106E1 away from the joint assembly 106E1. For example, the knob 108E can include one or more sockets, recesses, protrusions, and / or similar structures to support the attachment of one or more striking tools, pushing tools, and / or rotating tools, such as handles, crowbars, wrenches, ratchets, Allen keys, hex keys, box wrenches, and / or similar tools configured to strike, push, and / or rotate the knob 108E and the tapered piston 106E2.

[0139] Additionally, the knob 108E can be used to attach one or more rotational tools (e.g., a handle, a wrench, a ratchet, an Allen key, a hex key, a Torx wrench, and / or the like) that are configured to rotate the knob 108E when inserted into the intramedullary cavity, thereby rotating the device 100E, particularly the distal portion of the shaft and the laterally expandable element 104E.

[0140] Optionally, the device 100E may include one or more locking elements 112C, such as locking element 112A, for locking the tapered piston 106E2 in place to limit its movement and prevent movement of the laterally expandable element 104E, thereby maintaining its outer diameter 130 in a fixed state.

[0141] Optionally, the device 100E may include a dial 114C (such as dial 114A) and a pointer that indicate the outer diameter 130 of the laterally expandable element 104C.

[0142] Optionally, one or more of the laterally expandable elements 104E may be shaped with outwardly curved sides, such as L-shaped sides and / or the like, to improve bone marrow extraction and medullary canal formation when the laterally expandable element 104E is rotated within the medullary cavity.

[0143] Optionally, one or more of the laterally expandable elements 104E may be shaped with sharp edges to further improve bone marrow extraction and medullary canal formation when the laterally expandable element 104E is rotated within the medullary cavity.

[0144] Now refer to Figure 6 , which shows perspective and side views of an exemplary handle attached to operate a device with an adjustable diameter for forming a tube in an intramedullary cavity in retracted and expanded states according to some embodiments of the present invention.

[0145] As previously described, medullary canal formation devices, such as the devices 100A, 100B, 100C, 100D, and / or 100E, may include knobs 108A, 108B, 108C, 108D, and / or 100E, respectively, configured for attachment of one or more tools 600 (e.g., handles, crowbars, wrenches, ratchets, Allen keys, hex keys, box wrenches, and / or similar tools configured to strike, push, pull, and / or rotate the knob 108). 108D and / or 108E (collectively referred to as knobs 108) to respectively operate an actuator such as actuators 106A, 106B, 106C, 106D and / or 106E (collectively referred to as actuators 106) to respectively cause the conversion of multiple laterally expandable elements such as elements 104A, 104B, 104C, 104D and / or 104E (collectively referred to as laterally expandable elements 104) to adjust their outer diameters 130.

[0146] The main view now refers to Figure 7A 、 Figure 7B and Figure 7C , which are stereoscopic, front, side, top and bottom views of a sixth exemplary embodiment of a device with an adjustable diameter for forming a tube in a medullary cavity according to some embodiments of the present invention in a retracted state and an expanded state.

[0147] An exemplary apparatus 100F configured and operable to form a tube in the medullary cavity of one or more bones may include a shaft 102F, an actuator 106F, and a laterally expandable assembly comprising an expandable element 104F disposed along at least a portion of the shaft, such as at a distal end portion of the shaft configured for insertion into the medullary cavity during a tube forming procedure.

[0148] In particular, the actuator 106F may include a pressure pump (e.g., a manual pump, an electric pump, a hydraulic pump, and / or the like) configured to expand or contract the expandable element 104F to adjust the outer diameter 130 of the expandable element 104F. The actuator 106F may also include one or more pump rods 106F (e.g., a first pump rod 106F1 and a second pump rod 106F2) that can be used to manually operate the pressure pump to expand and contract the expandable element 104F.

[0149] The actuator 106F can be operated to expand and contract the expandable element 104F, and the outer diameter of the expandable element 104F can be adjusted using multiple states between the fully contracted state and the fully expanded state. The multiple states between the fully contracted state and the fully expanded state can correspondingly limit the outer diameter 130 to a range between the minimum outer diameter 130A and the maximum outer diameter 130B.

[0150] Optionally, the actuator 106F may include a fluid (e.g., liquid, gas (e.g., air) and / or the like) inlet for connecting to a pressure tube through which pressurized fluid is pushed to expand the expandable element 104F and / or release the fluid to deflate the expandable element 104F.

[0151] The device 100F may further include a rotation knob 108F that may be operated to rotate the device 100F (particularly the expandable device 104F), for example, while the shaft 102F is inserted into the intramedullary cavity.

[0152] Now refer to Figure 8 , which shows perspective and side views of an exemplary device with an adjustable diameter for forming a tube in the medullary cavity using various tips, according to some embodiments of the present invention.

[0153] As previously described, devices for forming a tube within the medullary cavity, such as devices 100A, 100B, 100C, 100D, 100E and / or 100F, can be configured and / or formed to have various end types at the distal end of their axes, such as axes 102A, 102B, 102C, 102D, 102E and / or 102F (hereinafter collectively referred to as axes 102).

[0154] The distal end of the shaft 102 can be formed into one or more shapes to improve the efficiency, robustness, and / or reliability of medullary canal formation. For example, the distal end of the shaft 102 can be configured to have a rounded end 800A. In another example, the distal end of the shaft 102 can be configured to have a pointed end 800B, which can improve penetration of the device 100 into the medullary canal.

[0155] Now refer to Figure 9 , which is a flow chart of an exemplary process for forming a tube in a medullary cavity using a device with an adjustable diameter according to some embodiments of the present invention.

[0156] The exemplary process 900 for forming a canal within the medullary cavity of a bone can be implemented during and / or in preparation for one or more medical and / or surgical procedures. For example, in preparation for a shoulder arthroplasty (e.g., a reverse shoulder arthroplasty, a total shoulder arthroplasty, and / or the like), the process 900 can be implemented to form a medullary canal in a humerus in which a prosthesis is to be implanted.

[0157] The process 900 can be implemented using a device such as devices 100A, 100B, 100C, 100D, 100E and / or 100F (collectively referred to herein as device 100), which has a shaft 102, an actuator 106 and a laterally expandable element 104, wherein the laterally expandable element has an outer diameter 130, and the outer diameter 130 is adjustable by movement of the actuator 106 relative to the shaft 102, which movement can be controlled by a knob 108.

[0158] Reference numerals 102, 104, 106, and 108 are used to collectively designate components that are corresponding components in the embodiments previously described herein. For example, shaft 102 is a collective term for shafts 102A, 102B, 102C, 102D, 102E, and 102F. In another example, laterally expandable assembly 104 is a collective term for laterally expandable elements 104A, 104B, 104C, 104D, 104E, and 104F. In another example, actuator 106 is a collective term for lateral actuators 106A, 106B, 106C, 106D, 106E, and 106F. In another example, laterally expandable assembly 104 is a collective term for laterally expandable elements 104A, 104B, 104C, 104D, 104E, and 104F. In another example, knob 108 is a collective term for knobs 108A, 108B, 108C, 108D, 108E, and 108F.

[0159] The process 900 is an iterative process in which the outer diameter 130 of the transversely expandable assembly 104 is gradually increased in steps to gradually increase the diameter of the tube formed within the intramedullary cavity until the desired tube diameter is reached.

[0160] As shown at 902, the outer diameter of the device 100 can be set to a minimum diameter. In particular, the outer diameter 130 of the portion (segment) of the device 100 intended for insertion into the intramedullary canal is set to its minimum diameter. The portion of the device 100 inserted into the intramedullary canal can include at least the transversely expandable assembly 104 and the shaft 102 and / or portions thereof. Thus, its outer diameter 130 is related to the outer diameter of the transversely expandable assembly 104.

[0161] To this end, locking elements (eg, locking elements 112A, 112B, and / or 112C) may be released to enable movement of the actuator 106 relative to the shaft 102 .

[0162] When the locking element is in its released state, the actuator 106 is operable via the knob 108 to move relative to the shaft 102 and cause the laterally expandable assembly 104 to transition to its most retracted and / or contracted state, thereby having a minimum outer diameter 130 .

[0163] Operation of the knob 108 to move the actuator 106 may depend on the particular embodiment as previously described. For example, in the case of devices 100A, 100B, 100C, 100D, and / or 100E, a handle, a wrench, a key, and / or the like may be attached to the knob 108 via a polygonal socket, recess, and / or protrusion, such as polygonal sockets 110A, 110B, 110C, 110C, and / or 110E, respectively.

[0164] As shown at 904, the device 100, and in particular the distal portion of the device 100 including the shaft 102 and the laterally expandable member 104, may be inserted into the medullary cavity of a bone to form a medullary canal within the medullary cavity.

[0165] Typically, after the bone roof is removed to expose the medullary cavity, the device 100 is inserted into a guide hole formed in the medullary cavity.

[0166] Optionally, the device 100 can be used to create a pilot hole. For example, the device 100 can be configured such that the outer diameter 130 of the laterally expandable component 104 can range from a very small diameter suitable for forming a pilot hole (e.g., 4 mm and / or 5 mm).

[0167] As shown at 906, the outer diameter 130 of the laterally expandable assembly 104 may be slightly increased. For example, assuming the initial minimum diameter is 5 mm, the outer diameter 130 may be set to 6 mm. In another example, assuming the outer diameter 130 was set to 11 mm in the previous iteration, the outer diameter 130 may be set to 12 mm.

[0168] When the locking element is in its unlocked (released) state, the outer diameter 130 can be adjusted as previously described by operating the knob 108. For example, a handle attached to the knob can be operated (e.g., rotated) to move the actuator 106 relative to the shaft 102 and adjust the diameter of the laterally expandable assembly 104 accordingly.

[0169] As shown in 908, once inserted into the medullary cavity, the device 100 can be manipulated, for example, by rotating, pushing, advancing, advancing, tapping, and / or the like, to extract bone marrow and form a medullary canal in the bone. For example, in the case of devices 100A, 100B, 100C, 100D, and / or 100E, a tool attached to the knob 108 can be rotated to rotate the device within the medullary cavity. In another example, in the case of device 100F, the knob 108F can be rotated to rotate the device within the medullary cavity.

[0170] In particular, the device 100 can be rotated while the locking element is in the locked state, thereby limiting movement of the actuator 106 relative to the shaft 102 and preventing undesirable changes in the outer diameter 130 of the laterally expandable assembly 104 .

[0171] As shown at 910, this is a conditional step, and if the desired tube diameter is achieved, the process may branch to 912. However, if the diameter of the medullary canal is less than the desired diameter, the process may branch back to 906 to begin another iterative process, wherein the outer diameter 130 of the transversely expandable assembly 104 may be further increased and the tube forming operation repeated (step 908).

[0172] As shown at 912, because the diameter of the medullary canal has reached the desired diameter, the canal forming operation may be concluded and the device 100 may be removed from the medullary cavity of the bone.

[0173] Typically, before removing the device 100 from the intramedullary canal, the outer diameter 130 of the transversely expandable assembly 104 can be reduced to facilitate smooth removal of the device 100 from the intramedullary canal. For example, when one or more locking elements are in their released state, the actuator 106 can be operated and / or moved to adjust the outer diameter 130 of the transversely expandable assembly 104 to a minimum diameter.

[0174] The description of various embodiments of the present invention is presented for illustrative purposes and is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles, practical applications, or technical improvements of the embodiments relative to the technology found in the market, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

[0175] As used herein, the term "about" refers to ±10%.

[0176] The terms "comprises," "comprising," "includes," "including," "having," and conjugations thereof mean "including but not limited to." This term encompasses the terms "consisting of" and "consisting essentially of.

[0177] The phrase "consisting essentially of means that the composition or method may include additional ingredients and / or steps, but only if the additional ingredients and / or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

[0178] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0179] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0180] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments.” Unless such features are incompatible, any particular embodiment of the present invention may include multiple “optional” features.

[0181] In this application, various embodiments of the present invention can be presented in the form of ranges. It should be understood that the description of ranges is only for convenience and brevity and should not be interpreted as an unchangeable limitation on the scope of the invention. Accordingly, the description of the range should be considered to have specifically disclosed all possible sub-ranges and each numerical value within the range. For example, the description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges 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, and each numeral within the range, such as 1, 2, 3, 4, 5 and 6. Regardless of the width of the range, all apply.

[0182] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integer) within the indicated range. The phrases "a range between" a first indicated numeral and a second indicated numeral and "a range from" a first indicated numeral to a second indicated numeral are used interchangeably herein and are meant to include the first and second indicated numerals and all fractions and integers therebetween.

[0183] It should be understood that certain features of the invention, which, for the sake of clarity, are described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which, for the sake of brevity, are described in the context of a single embodiment, may also be provided separately, in any suitable subcombination, or in any other embodiment described herein as appropriate. Specific features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment cannot be implemented without those elements.

[0184] Although the present invention has been described in conjunction with specific embodiments, it is obvious that many substitutions, modifications and variations are obvious to those skilled in the art. It is therefore intended to encompass all such substitutions, modifications, equivalents and variations that fall within the spirit and scope of the appended claims.

[0185] It is the applicant's intention that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety, just as if each individual publication, patent, or patent application were specifically and individually indicated as being incorporated herein by reference. Furthermore, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Where section headings are used, they should not be construed as necessarily limiting. Furthermore, the contents of any priority document claimed in this application are incorporated herein by reference in their entirety.

Claims

1. A device for forming a tube in the medullary cavity of a bone, comprising: a shaft having a proximal portion and a distal portion; an actuator configured to be movable relative to the shaft, and a transversely expandable assembly operably coupled to the distal portion of the shaft, the transversely expandable assembly configured to transition between a retracted state and an expanded state in a transverse axis perpendicular to the longitudinal axis of the shaft; wherein movement of the actuator relative to the shaft causes the laterally expandable assembly to transition between the retracted state and the expanded state to adjust an outer diameter of the laterally expandable assembly.

2. The device according to claim 1, wherein the outer diameter is 4 to 20 mm.

3. The apparatus of claim 1 , wherein the laterally expandable assembly is configured to transition between a plurality of discrete stepped states distributed between a retracted state and an expanded state.

4. The device of claim 1, wherein the laterally expandable assembly is configured to continuously transition between a retracted state and an expanded state.

5. The device of claim 1, further comprising a distal end of the shaft being pointed.

6. The device of claim 1, further comprising a locking element configured to limit movement of the actuator relative to the shaft and prevent changes in expansion and / or retraction of the laterally expandable assembly.

7. The apparatus of claim 1 further comprising a dial and a pointer mechanically coupled to the actuator for indicating the outer diameter.

8. A device according to claim 1, wherein the laterally expandable assembly includes a plurality of laterally expandable elements, which are arranged along at least a portion of the shaft and are mechanically coupled to the shaft by the actuator, and the actuator includes a joint assembly having a plurality of rods, which are tiltable for retracting and expanding the laterally expandable elements.

9. The device according to claim 8, wherein the joint assembly includes a first joint assembly and a second joint assembly, each of the first joint assembly and the second joint assembly includes a plurality of rods, the first joint assembly is fixed on the longitudinal axis of the shaft, and the second joint assembly is movable on the longitudinal axis of the shaft, the inclination of the plurality of rods is proportional to the distance between the first joint assembly and the second joint assembly, and the distance can be adjusted by moving the second joint assembly on the longitudinal axis through a knob mounted on the proximal end of the shaft.

10. The device of claim 9 , wherein the shaft has a threaded exterior that passes through the threaded bore of the first joint assembly and the threaded bore of the second joint assembly, the threaded shaft being rotatable by the knob such that rotation of the knob rotates the threaded shaft, thereby causing the movable second joint assembly to move relative to the fixed first joint assembly on the longitudinal axis of the threaded shaft, and the distance between the first joint assembly and the second joint assembly to be adjusted accordingly.

11. The device of claim 10, wherein the knob comprises a polygonal socket and / or a polygonal protrusion at a surface opposite to the shaft for attaching a rotating handle.

12. The device according to claim 9, wherein the shaft includes an inner shaft, which is arranged in the hole of the outer hollow shaft so that the inner shaft extends out of the outer shaft, the inner shaft is fixed to the fixed section of the knob, and the outer shaft mechanically coupled to the second section of the knob is movable on the longitudinal axis, and vice versa; the first joint assembly is arranged on the fixed shaft, and the second joint assembly is arranged on the movable shaft, the linear movement of the first section of the knob relative to the second section of the knob causes the inner shaft to move relative to the outer shaft on the longitudinal axis, so that the movable second joint assembly moves relative to the fixed first joint assembly on the longitudinal axis of the shaft, and the distance between the first joint assembly and the second joint assembly is adjusted accordingly.

13. The device of claim 8, further comprising at least one spring element configured to transition between a compressed state and a released state, the tilting of the plurality of rods being proportional to the compression of the at least one spring element.

14. The device of claim 8, further comprising at least one expandable element configured to transition between an expanded state and a contracted state, the tilting of the plurality of rods being proportional to the expansion of the at least one expandable element.

15. The apparatus of claim 8, further comprising at least one of the plurality of laterally expandable elements being shaped to have outwardly curved sides.

16. The apparatus of claim 8, further comprising at least one of the plurality of laterally expandable elements being shaped to have a sharp edge.

17. The device of claim 1 , wherein the transversely expandable assembly comprises an annular spring element disposed along at least a portion of the shaft and mechanically coupled to the shaft by the actuator, the actuator comprising a joint assembly including a first joint assembly fixed along the longitudinal axis of the shaft and a second joint assembly movable along the longitudinal axis of the shaft, the expansion and retraction of the annular spring element being proportional to the distance between the first joint assembly and the second joint assembly, the distance being adjustable by moving the second joint assembly along the longitudinal axis via a knob mounted at the proximal end of the shaft.

18. The device of claim 1 , wherein the laterally expandable assembly comprises a plurality of laterally expandable elements arranged along at least a portion of the shaft and mechanically coupled to the shaft via the actuator, the actuator comprising a tapered piston movable along the longitudinal axis of the shaft for causing the laterally expandable assembly to transition between a retracted state and an expanded state to adjust an outer diameter of the laterally expandable assembly.

19. A method of forming a medullary canal in a bone, comprising: configuring an outer diameter of a transversely expandable component of a medullary canal forming device to a minimum value, the outer diameter being defined by an actuator movable relative to a shaft of the device for transitioning the transversely expandable component between a retracted state and an expanded state; inserting a distal portion of the device into a guide hole created in the medullary cavity of a bone to form a canal in the bone; increasing the outer diameter by moving the actuator relative to the shaft to expand the laterally expandable assembly; rotating the shaft to increase the diameter of the tube; gradually increasing the outer diameter and rotating the shaft to increase the diameter of the tube until a desired diameter is reached; reducing the outer diameter by moving the actuator relative to the shaft to retract the laterally expandable assembly; as well as The device is removed from the medullary cavity.

20. The method of claim 19, wherein the medullary canal is formed for insertion of a prosthetic implant.

21. The method of claim 19, further comprising using the device to create the guide hole in the medullary cavity.

22. A device for forming a tube in the medullary cavity of a bone, comprising: a shaft having a proximal portion and a distal portion; a laterally expandable assembly operably coupled to the distal portion of the shaft, the laterally expandable assembly comprising an expandable element; as well as An actuator is configured to expand and contract the expandable member to adjust an outer diameter of the expandable member.

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