Bone rushing instrument

Abstract

A medical device configured to form one or more apertures within a bone of a patient, comprising: a handle assembly comprising a housing, a rod rotatably coupled to the housing, and a sheath extending distally from the housing, the handle assembly comprising a spring biasing the rod toward an initial or intermediate position; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, the piercing tip configured to be driven into a bone. The elongate shaft may be slidably disposed within the sheath in a first position when the rod is in an initial or intermediate position. Translation of the bone punch distally within the sheath from a first position to a second position may cause rotation of the distal end of the rod away from the housing to an extended position.

Description

[0001] This application is a divisional application of application number 202180032690.7, filed on March 18, 2021, entitled "Bone Stroke Instrument".

[0002] Cross-references to related applications

[0003] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 62 / 991,993 entitled "Bone Puncture Device" filed on March 19, 2020, and U.S. Provisional Patent Application Serial No. 63 / 091,107 entitled "Bone Puncture Device" filed on October 13, 2020, the disclosures of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to medical devices and methods for manufacturing and / or using medical devices. More specifically, this disclosure relates to devices for creating pores in bone within a patient's body, and methods for manufacturing and using such devices. Background Technology

[0005] Injuries may require the placement of anchors and / or implants into a patient's bone for repair. In one example, tendon injuries can be treated by attaching a tendon repair implant to one or more bones associated with a joint, such as the glenohumeral joint. This attachment may use anchoring members, such as nails, or other fixation elements that are at least partially inserted into the bone, and in some cases, at least partially inserted into holes formed in the bone to receive the anchoring member, nail, or other fixation element. Due to the cortical elasticity of bone, forming these holes and subsequently removing the tools used to form them can be difficult. Each of the known medical devices and methods of manufacturing and using these devices has certain advantages and disadvantages. There is a continuous need for improved and / or alternative medical devices and methods of manufacturing and using these devices. Summary of the Invention

[0006] In one example, a medical device configured to form one or more holes in a patient's bone may include a handle assembly comprising a housing, a rod rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch comprising an elongated shaft, a head at a proximal end of the elongated shaft, and a puncture tip at a distal end of the elongated shaft, wherein the puncture tip is configured to be driven into the bone. When the rod is in the initial position, the elongated shaft may be slidably disposed within the sheath in a first position. Translation of the bone punch distally from the first position to a second position within the sheath may cause the distal end of the rod to rotate away from the housing to the extended position.

[0007] As a supplement to or alternative to any example disclosed herein, the head of the bone punch is releasably engaged with the housing in a first position.

[0008] As a supplement to or alternative to any example disclosed herein, the distal surface of the head of the bone punch engages the proximal surface of the housing in a second position.

[0009] As a supplement to or alternative to any example disclosed herein, less than 40% of the puncture tips extend distally to the sheath in the first position.

[0010] As a supplement to or alternative to any example disclosed herein, the bone punch is translated distally within the sheath from a first position to a second position, causing the distal end of the rod to rotate away from the longitudinal axis of the bone punch.

[0011] As a supplement to or alternative to any of the examples disclosed herein, the distal end of the sheath is configured to be positioned adjacent to the bone surface. The rotational position of the rod relative to the sheath indicates the depth of the puncture tip within the bone.

[0012] As a supplement to or alternative to any example disclosed herein, rotation of the rod from the extended position to the initial position causes the bone punch to translate proximally to remove the puncture tip from the bone.

[0013] As a supplement to or alternative to any example disclosed herein, the handle assembly includes a spring that biases the lever toward its initial position.

[0014] In a second example, a medical device configured to form one or more holes within a patient's bone may include: a handle assembly comprising a housing, a rod rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch comprising an elongated shaft, a head at a proximal end of the elongated shaft, and a puncture tip at a distal end of the elongated shaft, wherein the puncture tip is configured to be driven into the bone. When the rod is in the initial position, the elongated shaft may be slidably disposed within the sheath in a first position. The handle assembly may include a connecting rod disposed within the housing. The head of the bone punch may engage the connecting rod in the first position, and translation of the bone punch distally from the first position to a second position may cause the connecting rod to rotate the distal end of the rod away from the housing to the extended position.

[0015] As a supplement to or alternative to any example disclosed herein, the linkage includes an ejector block slidably disposed within the housing.

[0016] As a supplement to or alternative to any example disclosed herein, the linkage also includes a distal connection that pivotally engages with the housing at a distal pivot point and an intermediate connection that pivotally engages with the ejector block at a proximal pivot point.

[0017] As a supplement to or alternative to any of the examples disclosed herein, the distal connection pivotally engages with the intermediate connection at an intermediate pivot point between the distal pivot point and the proximal pivot point.

[0018] As a supplement to or alternative to any example disclosed herein, the distal connection includes a cam surface configured to engage a lever.

[0019] As a supplement to or alternative to any example disclosed herein, the head of the bone punch is translated distally from the first position to the second position, causing the ejector block to translate distally within the housing.

[0020] As a supplement to or alternative to any example disclosed herein, when the bone punch is in the second position, the rotation of the rod toward the longitudinal axis of the bone punch actuates the linkage to cause the head of the bone punch to translate proximally, thereby removing the puncture tip from the bone.

[0021] As a supplement to or alternative to any example disclosed herein, the handle assembly includes a spring that biases the lever toward its initial position.

[0022] In a third example, a medical device configured to form one or more holes within a patient's bone may include: a handle assembly comprising a housing, a rod rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch comprising an elongated shaft having gear teeth extending outwardly therefrom, a head at a proximal end of the elongated shaft, and a puncture tip at a distal end of the elongated shaft, wherein the puncture tip is configured to be driven into the bone. When the rod is in the initial position, the elongated shaft may be slidably disposed within the sheath in a first position. The handle assembly may include a plurality of gears disposed within the housing, at least one of the gears being configured to mesh with the gear teeth of the elongated shaft. In the first position, the head of the bone punch may be spaced apart from a proximal surface of the housing, and translation of the bone punch distally from the first position to a second position may cause the plurality of gears to rotate the distal end of the rod away from the housing to the extended position.

[0023] As a supplement to or alternative to any example disclosed herein, in the initial position, the rod engages with the outer surface of the housing.

[0024] As a supplement or alternative to any example disclosed herein, in the initial position, the rod extends generally parallel to the longitudinal axis of the sheath toward the distal end of the sheath.

[0025] As a supplement to or alternative to any example disclosed herein, in the extended position, the rod extends toward the distal end of the sheath at an angle to it.

[0026] As a supplement to or alternative to any example disclosed herein, in the second position, the distal surface of the head of the bone punch engages with the proximal surface of the outer shell.

[0027] As a supplement to or alternative to any example disclosed herein, the plurality of gears includes a first gear configured to mesh with gear teeth of an elongated shaft, a second gear fixedly attached to a rod, and a third gear meshing with the first and second gears.

[0028] In a fourth example, a medical device configured to form one or more holes within a patient's bone may include: a handle assembly comprising a housing, a rod rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch comprising an elongated shaft, a head at a proximal end of the elongated shaft, and a puncture tip at a distal end of the elongated shaft, wherein the puncture tip is configured to be driven into the bone. When the rod is in the initial position, the elongated shaft may be slidably disposed within the sheath in a first position. The handle assembly may include a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing. The head of the bone punch may be releasably coupled to the ejector block in the first position, and translation of the bone punch distally from the first position to a second position may cause the linkage to rotate the distal end of the rod away from the housing to the extended position.

[0029] As a supplement to or alternative to any example disclosed herein, the head of the bone punch is magnetically coupled to the ejector block.

[0030] As a supplement to or alternative to any example disclosed herein, the head of the bone punch includes one or more magnets disposed therein, and the ejector block includes magnetic material disposed therein, opposite to the one or more magnets.

[0031] As a supplement to or alternative to any example disclosed herein, the ejector block includes one or more magnets disposed therein, and the head of the bone punch includes magnetic material disposed therein, opposite to the one or more magnets.

[0032] As a supplement to or alternative to any example disclosed herein, the head of the bone punch includes one or more magnets disposed therein, and the ejector block includes one or more magnets disposed therein, opposite to the one or more magnets disposed in the head of the bone punch.

[0033] As a supplement to or alternative to any example disclosed herein, the head of the bone punch is translated distally from the first position to the second position, causing the ejector block to translate distally within the housing.

[0034] As a supplement to or alternative to any example disclosed herein, when the bone punch is in the second position, rotation of the rod from the extended position toward the longitudinal axis of the bone punch causes the bone punch to translate proximally to remove the puncture tip from the bone.

[0035] As a supplement to or alternative to any example disclosed herein, at least a portion of the head of the bone punch is configured to pass through an opening in the wall of the housing as the bone punch translates from a first position to a second position.

[0036] The above overview of some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or implementation of the invention. The following drawings and detailed description illustrate these embodiments in more detail. Attached Figure Description

[0037] This disclosure will be more fully understood in conjunction with the accompanying drawings, in which:

[0038] Figure 1 It is a stylized front view of the shoulder, including the humerus and scapula;

[0039] Figure 2 It is a stylized front view of the shoulder, depicting the head of the humerus, showing it engaging with the glenoid fossa of the scapula at the glenohumeral joint, with sheet material fixed to the tendon;

[0040] Figure 3 These are three-dimensional diagrams of some aspects of an example bone punch;

[0041] Figure 4 These are side views of some aspects of an example medical device;

[0042] Figure 5 Show Figure 4 In some aspects of traditional Chinese medicine devices, the rod is in an initial or intermediate position;

[0043] Figure 6 Show Figure 4 Some aspects of traditional Chinese medicine devices, in which the rod is in an extended position;

[0044] Figure 7 yes Figure 4 Detailed diagrams of some aspects of traditional Chinese medicine devices, in which the rod is in... Figure 6 The extended position in;

[0045] Figure 8-10 yes Figure 4 Three-dimensional diagrams of some aspects of traditional Chinese medicine devices, in which the rod is in Figure 6 The extended position in;

[0046] Figure 11 Show Figure 4 In some aspects of traditional Chinese medicine devices, the rod is in a detached position;

[0047] Figure 12 yes Figure 4 Medical devices and Figure 3 A partial cross-sectional view of the bone punch in the implantation site after it is driven into the bone at the implantation site;

[0048] Figure 13 yes Figure 4 Medical devices and Figure 3 A partial cross-sectional view of the bone punch at the implantation site after it is driven into and removed from the bone.

[0049] Figure 14 This is a 3D view of an example bone screw inserter;

[0050] Figure 15 This is a 3D diagram of an example bone screw;

[0051] Figure 16 These are side views of some aspects of an example medical device;

[0052] Figure 17 Show Figure 16 Some aspects of traditional Chinese medicine devices, in which the rod is in its initial position;

[0053] Figure 18 Show Figure 16 Some aspects of traditional Chinese medicine devices, in which the rod is in an extended position;

[0054] Figure 19 These are three-dimensional diagrams of some aspects of an example bone punch;

[0055] Figure 19A It is along Figure 19 A view of the bone punch taken from line 19A-19A in the middle;

[0056] Figure 20 These are side views of some aspects of an example medical device;

[0057] Figure 21 Show Figure 20 In some aspects of traditional Chinese medicine devices, the rod is in an initial or intermediate position;

[0058] Figure 22 Show Figure 20 Some aspects of traditional Chinese medicine devices, in which the rod is in an extended position;

[0059] Figure 23 yes Figure 20 Detailed diagrams of some aspects of traditional Chinese medicine devices, in which the rod is in... Figure 22 The extended position in;

[0060] Figure 24 Show Figure 20 In some aspects of traditional Chinese medicine devices, the rod is in a detached position; and

[0061] Figure 25 Show Figure 20 Selected aspects of example configurations of traditional Chinese medicine devices;

[0062] Figure 26 Show Figure 20 Selected aspects of example configurations of traditional Chinese medicine devices; and

[0063] Figure 27 Show Figure 20 Selected aspects of example configurations of traditional Chinese medicine devices.

[0064] While various modifications and alternatives may be made to some aspects of this disclosure, details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to limit its aspects to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0065] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which the same reference numerals denote the same elements in multiple views. The detailed description and drawings are intended to illustrate, and not limit, the claimed invention. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate exemplary embodiments of the claimed invention. However, for clarity and ease of understanding, although each feature and / or element may not be shown in every figure, its presence is to be understood unless otherwise stated.

[0066] The terms defined below shall be used as defined unless otherwise specified in the claims or elsewhere in this specification.

[0067] This document assumes that all numerical values ​​are modified by the term "about," whether explicitly stated or not. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to (e.g., having the same function or result) the listed values. In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term "about" (e.g., in contexts other than numerical values) are assumed to have their common and customary definitions, as understood from and consistent with the context of the specification.

[0068] Endpoint references to a range of numbers include all numbers in that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0069] Although some suitable dimensions, ranges and / or values ​​relating to various components, features and / or specifications are disclosed, those skilled in the art will understand, inspired by this disclosure, that expected dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0070] As used in this specification and the appended claims, the singular forms “a” and “some” include plural indicators unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless otherwise expressly stated. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular form, even if such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by a single disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the disclosed invention need to be shown in every figure or discussed in detail below. However, it should be understood that, unless expressly stated to the contrary, the following discussion applies equally to any and / or all components, not just one. Furthermore, for clarity, not all instances of certain elements or features are shown in every figure.

[0071] Regarding the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, relative terms such as “proximal,” “distal,” “advancing,” “retracting,” and variations thereof may generally be considered, where “proximal” and “retracting” indicate or refer to being closer to or toward the user, while “distal” and “advancing” indicate or refer to being further away from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily specified for the purpose of understanding this disclosure, and such examples will be apparent to those skilled in the art. Other related terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a cavity such as a body cavity, blood vessel, or device. Other related terms, such as “axial,” “circumferential,” “longitudinal,” “transverse,” “radial,” and / or variations thereof, generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0072] The term “range” can be understood as referring to the maximum measured value of a specified or defined dimension, unless a “minimum” is previously specified or determined to be a “minimum”, in which case it can be understood as referring to the minimum measured value of the specified or defined dimension. For example, “outer range” can be understood as an outer dimension, “radial range” as a radial dimension, “longitudinal range” as a longitudinal dimension, and so on. Each instance of “range” can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be obvious to those skilled in the art depending on the context in which it is used. Generally, “range” can be considered as the maximum possible dimension measured according to its intended use, while “minimum range” can be considered as the minimum possible dimension measured according to its intended use. In some cases, “range” can typically be measured orthogonally within a plane and / or section, but as is obvious from the particular context, it can be measured in different ways—e.g., but not limited to angles, radial, circumferential (e.g., along arcs), etc.

[0073] The terms “integral” and “single” generally refer to one or more elements made or composed of a single structure or basic unit / element. Integral and / or single element shall exclude structures and / or features made by assembling or otherwise combining multiple discrete structures or elements, especially where those discrete structures or elements remain individually identifiable.

[0074] It should be noted that references to "one embodiment," "some embodiments," or "other embodiments" in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Moreover, whether explicitly described or not, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, implementing that specific feature, structure, or characteristic in conjunction with other embodiments will be within the knowledge of those skilled in the art, unless explicitly stated otherwise. That is, even if not explicitly shown in a specific combination, the various individual elements described below are contemplated as being able to be combined or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0075] For clarity, certain identifying numerical notations (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical notations are not intended to be limiting, but are merely illustrative. In some embodiments, for brevity and clarity, the previously used numerical notations may be modified and deviated from. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or a different feature may be referred to as a “first” element. The meaning and / or name in each case will be obvious to a skilled practitioner.

[0076] Appendix Figure 1 The disclosure generally illustrates selected components and / or arrangements of a medical device or apparatus. It should be noted that, for simplicity, some features of the medical device or apparatus may not be shown or may be shown schematically in any given figure. Additional details regarding some elements of the medical device or apparatus may be shown in more detail in other figures. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by a single disclosure, unless explicitly stated otherwise. For example, a reference to a feature or element may equally refer to all instances and numbers beyond one of said feature or element. Therefore, it should be understood that, unless explicitly stated otherwise, the following discussion applies equally to any and / or all elements within the medical device or apparatus that are more than one. Furthermore, for clarity, not all instances of certain elements or features are shown in every figure.

[0077] Figure 1 This is a stylized front view of patient 20, showing an example area from which the disclosed invention may benefit. For illustrative purposes, the shoulder 22 of patient 20 is shown... Figure 1 The image is shown in partial cross-section. The shoulder 22 includes the humerus 14 and the scapula 12. Figure 1 In the image, the head 24 of the humerus 14 can be seen fitting into the glenoid fossa of the scapula 12 at the glenohumeral joint. (Reference) Figure 1 It should be understood that the glenoid fossa includes the shallow depression in the scapula 12. Movement of the humerus 14 relative to the scapula 12 is controlled by several muscles, including the deltoid, supraspinatus, infraspinatus, subscapularis, and teres minor. For illustrative purposes, Figure 1 Only the supraspinatus muscle 26 is shown.

[0078] exist Figure 1 In the middle, the distal tendon 28 of the supraspinatus muscle 26 intersects the humerus 14 at the insertion point. The scapula 12 of the shoulder 22 includes the acromion 32. Figure 1In the image, the subacromial bursa 34 is shown extending between the acromion 32 of the scapula 12 and the head 24 of the humerus 14. The subacromial bursa 34 is shown covering the supraspinatus muscle 26 and the distal tendon 28, as well as a portion of the humerus 14. The subacromial bursa 34 is one of hundreds of bursae found in the human body. Each bursa consists of a fluid-filled sac. The presence of these bursae in the body reduces friction between body tissues.

[0079] In one example use of the disclosed medical device, the example nails or fasteners described herein can be used to secure tendon repair implants to various target tissues. Figure 1 The shoulder depicted in the image 22 is an example in which a tendon repair implant can be attached to one or more bones associated with a joint such as the glenohumeral joint. Furthermore, a tendon repair implant can be attached to one or more tendons to be treated. In some cases, the tendon to be treated may be torn, partially torn, have internal micro-tears, be untorn, and / or thinned due to age, injury, or overuse.

[0080] Figure 2 It is a stylized front view of the shoulder 22, including the humerus 14 and the scapula 12. Figure 2 In the image, the head 24 of the humerus 14 is shown engaging with the glenoid fossa of the scapula 12 at the glenohumeral joint. The supraspinatus muscle 26 is also shown. Figure 2 In the middle. This muscle, along with other muscles, controls the movement of the humerus 14 relative to the scapula 12. The distal tendon 28 of the supraspinatus 26 intersects the humerus 14 at the insertion point 30.

[0081] like Figure 2 As shown, the distal tendon 28 may include a first damaged portion 36. Numerous loose tendon fibers 40 within the first damaged portion 36... Figure 2 As can be seen, the first damaged portion 36 includes a first tear 42 that partially extends through the distal tendon 28. Therefore, the first tear 42 can be referred to as a partial thickness tear. Figure 2 In the middle, the first tear 42 is on the side of the distal tendon 28 facing the subacromial bursa (e.g. Figure 1 It begins and ends midway down the distal tendon 28. Therefore, the first tear 42 can be referred to as a bursal-side tear.

[0082] exist Figure 2 In this case, the distal tendon 28 also includes a second damaged portion 38 located near the insertion point 30. As shown, the second damaged portion 38 of the distal tendon 28 is worn and many loose tendon fibers 40 are visible. The second damaged portion 38 of the distal tendon 28 includes a second tear 44. The second tear 44 begins on the side of the distal tendon 28 facing the center of the head 24 of the humerus 14. Therefore, the second damaged portion 38 can be referred to as a lateral tear.

[0083] Figure 2 A sheet implant 50 is shown placed on the bursa side of the distal tendon 28. The sheet implant 50 can be secured to the distal tendon 28 by a plurality of tendon screws 51. The sheet implant 50 can be secured to the humerus 14 by one or more bone screws 100 or other similar and / or suitable bone anchors. The sheet implant 50 extends over the insertion point 30, the first tear 42, and the second tear 44. Some methods according to this disclosure may include placing the tendon repair implant on the bursa side of the tendon, regardless of whether the tear being treated is bursa-side, articular-side, or intratendonal. In some cases, the exact location and nature of the tear being treated may be unknown. In some cases, the tendon repair implant may be applied to the bursa side of the tendon to treat shoulder pain that is mostly caused by one or more partial thickness tears in the tendon.

[0084] In some embodiments, the medical device can be used to form one or more holes within a patient's bone (e.g., the humerus 14) to facilitate the placement of one or more bone screws 100 and / or fixation of the sheet implant 50 to the bone. In some embodiments, the medical device (e.g., Figure 4 The device may include a bone punch 270, which includes an elongated shaft 274, a head 276 disposed proximally to the elongated shaft 274, and a puncture tip 272 disposed distally to the elongated shaft 274, for example, as shown in the image. Figure 3 As shown. In some embodiments, the bone punch 270 and / or puncture tip 272 may include a plurality of puncture tips, two or more puncture tips, a pair of puncture tips, etc., extending distally from the distal end 275 of the elongated shaft 274. The puncture tip 272 may be configured to be driven into bone (e.g., humerus 14). In some embodiments, the puncture tip 272 may be a spike, a point, a spear, or other suitable shape. Thus, the puncture tip 272 may include a sharp distal end and / or a tapered distal portion configured to engage and / or penetrate bone.

[0085] In some embodiments, the head 276 of the bone punch 270 may include a plurality of connecting members 278. Each of the plurality of connecting members 278 may include a laterally extending projection 279. In some embodiments, the plurality of connecting members 278 may be fixedly attached to opposite sides of the head 276. The plurality of connecting members 278 may extend distally from the head 276 toward the distal end 275 of the elongated axis 274. The plurality of connecting members 278 may extend laterally outward from the head 276 at an angle to the longitudinal axis and / or the elongated axis 274 of the bone punch 270. In some embodiments, the plurality of connecting members 278 may be laterally outwardly biased from the head 276. Additional details regarding the plurality of connecting members 278 and their use will become apparent from the discussion herein.

[0086] In some embodiments, the head 276 may include one or more lateral protrusions. In some embodiments, the one or more lateral protrusions may be disposed between a plurality of connecting members 278 and / or between the proximal end and the distal end of the head 276. The one or more lateral protrusions may each and / or collectively define a distal surface 277 of the head 276. The distal surface 277 may be a distally facing surface but is not necessarily the most distal surface of the head 276. For example, the distal surface 277 may be disposed between the proximal end and the distal end of the head 276.

[0087] In some embodiments, the proximal end of the elongated shaft 274 may extend into the head 276 of the bone punch 270. In some embodiments, the proximal end of the elongated shaft 274 may be fixedly attached to the head 276. In some embodiments, the elongated shaft 274 may be integrally formed with the head 276, for example by casting, molding, or machining. Other configurations are also contemplated. Similarly, the proximal end of the puncture tip 272 may extend into the distal end 275 of the elongated shaft 274. The proximal end of the puncture tip 272 may be fixedly attached to the elongated shaft 274. In some embodiments, the puncture tip 272 may be integrally formed with the elongated shaft 274, for example by casting, molding, or machining. Other configurations are also contemplated. Some examples of suitable, but not limiting, materials for the bone punch 270 and / or its elements or components are described below.

[0088] Figure 4 A side view illustrates various aspects of a medical device configured to form one or more holes within a patient's bone. The medical device may include a handle assembly 200, which includes a housing 207, a rod 205 rotatably coupled to the housing 207, and a sheath 203 extending distally from the housing 207. In at least some embodiments, the proximal end of the sheath 203 may be fixedly attached to the housing 207. The sheath 203 may extend into and / or within the housing 207 such that the proximal end of the sheath 203 is disposed within a distal portion of the housing 207, and the sheath 203 is within the housing 207 and extends distally from the distal end of the housing 207. Several examples of suitable, but not limiting, materials for the housing 207, rod 205, sheath 203, and / or its elements or components are described below.

[0089] The housing 207 may be formed to include a first housing portion 207A ( Figure 4 (visible in the middle) and the second outer casing 207B ( Figure 4The housing is a multi-piece structure (not visible in the diagram). For illustrative purposes, one of the first housing portion 207A or the second housing portion 207B may be hidden in the view to allow viewing of its internal components and / or features. The first housing portion 207A and the second housing portion 207B may be assembled together to form housing 207. In the illustrated example, fasteners such as screws and nuts may be used to assemble housing 207. However, other components and / or attachment devices may also be used, including but not limited to snap-fit ​​engagements, friction engagements, pins, rivets, etc. In some embodiments, once housing 207 is assembled, such assembly may be considered and / or made permanent by any known suitable means, such as, but not limited to, adhesives, welding, etc.

[0090] The medical device may include the bone punch 270 described herein. The bone punch 270 may be disposed within and / or extend through a sheath 203. The head 276 of the bone punch 270 may releasably engage with the housing 207 in a first position, such as... Figure 4-5 As shown. The puncture tip 272 may be positioned in a first location near the distal end of the sheath 203. In some embodiments, the puncture tip 272 may be positioned in a first location within the distal end of the sheath 203. In some embodiments, a portion of the puncture tip 272 may extend distally from the distal end of the sheath 203 in the first location to aid in positioning the medical device at the treatment site (e.g., to engage the surface of bone). In some embodiments, less than 50% of the puncture tip 272 extends distally from the distal end of the sheath 203 in the first location. In some embodiments, less than 40% of the puncture tip 272 extends distally from the distal end of the sheath 203 in the first location. In some embodiments, less than 30% of the puncture tip 272 extends distally from the distal end of the sheath 203 in the first location. In some embodiments, less than 20% of the puncture tip 272 extends distally from the distal end of the sheath 203 in the first location. In some embodiments, less than 10% of the puncture tip 272 extends distally from the distal end of the sheath 203 in the first location. In some embodiments, less than 5% of the puncture tip 272 extends distally from the distal end of the sheath 203 at the first position.

[0091] Figure 5A medical device is shown in which a first housing portion 207A of a handle assembly 200 is removed, and a second housing portion 207B is visible. The housing 207 may include a leg 210 extending laterally from its distal portion. In some embodiments, the leg 210 may be located at and / or extend laterally from the distal end of the housing 207. A rod 205 may be rotatably and / or pivotally coupled to the housing 207 about a rotation axis. The handle assembly 200 may include a spring 211 that biases the rod 205 toward an initial position, such as a mid-position. In at least some embodiments, the spring 211 may include a coiled portion disposed about and / or coaxial with the rotation axis of the rod 205.

[0092] exist Figure 5 In the diagram, lever 205 is shown positioned in an initial or intermediate position. In at least some embodiments, starting from the initial or intermediate position, lever 205 may be configured to rotate its distal end 209 toward or away from housing 207. In the initial or intermediate position, the distal end 209 of lever 205 may be substantially aligned with and / or disposed within the free end of support leg 210. In the initial or intermediate position, lever 205 may extend distally toward the distal end of housing 203 and / or handle assembly 200 relative to the longitudinal axis of sheath 203. For example, the first angle may be less than about 15 degrees, less than about 10 degrees, less than about 5 degrees, about 0 degrees, or another small bevel angle. In some embodiments, in the initial or intermediate position, lever 205 may extend substantially parallel to the longitudinal axis of sheath 203 toward the distal end of sheath 203.

[0093] exist Figure 5 In the diagram, the bone punch 270 is shown positioned in a first position. When the lever 205 is in the initial or intermediate position, the elongated shaft 274 of the bone punch 270 is slidably disposed within the sheath 203 of the handle assembly 200. In the first position and / or when the lever 205 is in the initial or intermediate position, the head 276 of the bone punch 270 can be releasably engaged with the housing 207 of the handle assembly 200. For example, a plurality of connecting members 278 and their outwardly extending protrusions 279 can engage the wall of the housing 207 defining its proximal surface 208. In some embodiments, the proximal surface 208 can be a proximal-facing surface of the housing 207 at its proximal end and / or near its proximal end. In some embodiments, the proximal surface 208 can be the nearest-side surface of the housing 207.

[0094] In a first position, the outwardly extending protrusion 279 may extend laterally outward from the longitudinal axis and / or elongated axis 274 of the head 276 and / or bone punch 270 beyond the periphery of the opening in the wall of the housing 207 (in which the head 276 is disposed). The outwardly extending protrusion 279 prevents the head 276 and / or bone punch 270 from being removed from the housing 207 until the plurality of connecting members 278 are pressed, pushed, actuated, or otherwise moved inward toward the longitudinal axis and / or elongated axis 274 of the head 276 and / or bone punch 270 to separate the outwardly extending protrusion 279 from the wall of the housing 207 by translating the outwardly extending protrusion 279 inward until the outwardly extending protrusion 279 is disposed within and / or toward the periphery of the opening. Doing so will allow the plurality of connecting members 278 and the outwardly extending protrusion 279 to pass through the opening in the wall of the housing 207. In the first position, one or more lateral protrusions of the head 276 and / or the distal surface 277 of the head 276 may be spaced proximally from the proximal surface 208 of the wall of the housing 207.

[0095] In some embodiments, the handle assembly 200 may include a link 220 disposed within the housing 207. (Refer to...) Figure 7-10 A more detailed description of link 220 is provided. (e.g.) Figure 5 As shown, the head 276 of the bone punch 270 can engage the link 220 in a first position. The link 220 can be pivotally engaged with and / or pivotally coupled to the housing 207. The link 220 may include a plurality of elements that can move and / or pivot relative to each other. Distal translation of the bone punch 270 within the sheath 203 and / or translation of the head 276 of the bone punch 270 distally relative to the housing 207 from the first position to a second position distal to the first position can cause the link 220 to rotate the distal end 209 of the rod 205 away from the housing 207 and / or away from the longitudinal axis and / or the elongated axis 274 of the bone punch 270 to an extended position, such as... Figure 6 As shown. In the extended position, the rod 205 can extend at a second angle relative to the longitudinal axis of the sheath 203 toward the distal end of the sheath 203 and / or the handle assembly 200. In some embodiments, the second angle can be an oblique angle. The second angle can be greater than the first angle.

[0096] like Figure 6As shown, the distal surface 277 of the head 276 of the bone punch 270 can engage and / or abut the proximal surface 208 of the housing 207 in a second position. In the second position, the outwardly extending protrusion 279 can be spaced distally from the wall of the housing 207 that defines the proximal surface 208. However, the outwardly extending protrusion 279 can still extend laterally outward from the longitudinal axis and / or the elongated axis 274 of the head 276 and / or the bone punch 270 beyond the periphery of the opening in the wall of the housing 207 (in which the head 276 is disposed), thereby preventing the bone punch 270 from being accidentally removed from the handle assembly 200.

[0097] In the second position, as the elongated shaft 274 translates distally within the sheath 203, the puncture tip 272 can extend from the distal end of the sheath 203. The distal end of the sheath 203 can be configured to be adjacent to a bone surface. As the bone punch 270 translates distally to the second position, the puncture tip 272 can be driven into the bone to form one or more holes. There may be a direct or indirect correlation between the rotational position of the rod 205 relative to the housing 207 and the depth of the puncture tip 272 within the bone. As the rod 205 rotates away from the housing 207 and / or as the angle between the rod 205 and the longitudinal axis of the sheath 203 and / or the bone punch 270 increases, the puncture tip 272 can extend further distally from the distal end of the sheath 203 and / or can be driven deeper into the bone. The user of the medical device and / or handpiece assembly 200 can use the longitudinal axis of the lever 205 relative to the housing 207 and / or sheath 203 and / or the rotational position of the bone punch 270 to indicate the depth of the puncture tip 272 within the bone, thereby providing the user with visual cues about the status of the procedure.

[0098] Subsequently, rod 205 extends from its extended position (e.g., Figure 6 To the initial or intermediate position (e.g., Figure 5 The rotation of the puncture tip 270 generates a proximal force on the bone punch 270 sufficient to overcome the cortical elasticity of the bone (which "squeezes" or "pinches" the puncture tip 272) to pull the puncture tip 272 out of the bone. Therefore, the rod 205 moves from the extended position (e.g., Figure 6 To the initial or intermediate position (e.g., Figure 5 Rotation of the lever 205 allows the bone punch 270 to translate proximally, thereby removing the puncture tip 272 from the bone, leaving one or more holes formed in the bone. The linkage 220 provides a mechanical advantage in generating the force required to remove the puncture tip 272 from the bone, thus reducing the force the user needs to apply to the lever 205. Rotating the lever 205 from the extended position to the initial or intermediate position allows the bone punch 270 to translate from the second position back to the first position. Thereafter, if necessary, the bone punch 270 can be removed from the handle assembly 200, or the medical device can be removed from the treatment site.

[0099] Figure 7 yes Figure 6 A detailed view of a portion of the medical device shows a bone punch 270 positioned in a second location and a rod 205 positioned in an extended location. The connecting rod 220 may include an ejector block 221 slidably disposed within a housing 207. The ejector block 221 may include one or more pins 229 configured to engage the housing 207 and / or configured to slide longitudinally and / or axially within a channel formed in the housing 207. In some embodiments, the ejector block 221 may be configured to slide longitudinally and / or axially within a channel formed in the housing 207. In some embodiments, the ejector block 221 may be configured to slide parallel to the longitudinal axis of the sheath 203 and / or the longitudinal axis of the bone punch 270 and / or the elongated shaft 274. In some embodiments, the sheath 203 may extend through and / or pass through the ejector block 221. Therefore, the ejector block 221 may be slidably disposed around the sheath 203. Since the elongated shaft 274 may be slidably disposed within the sheath 203, the elongated shaft 274 may also extend through the ejector block 221. The head 276 of the bone punch 270 can be configured to engage the ejector block 221 in a first position. During the distal translation of the bone punch 270 from the first position to the second position, the head 276 of the bone punch 270 can push, squeeze, or otherwise translate the ejector block 221 distally within the housing 207, thereby actuating the linkage 220 and causing it to rotate the distal end 209 of the rod 205 away from the housing 207 to the extended position.

[0100] In at least some embodiments, the link 220 may further include a distal connection 222 pivotally engaged with the housing 207 at a distal pivot point 223, and an intermediate connection 224 pivotally engaged with the ejector block 221 at a proximal pivot point 225. In some embodiments, the intermediate connection 224 may include a first intermediate connection 224A and a second intermediate connection 224B (not shown). In some embodiments, a proximal portion of the distal connection 222 may be disposed between the first intermediate connection 224A and the second intermediate connection 224B. In some embodiments, the distal portion of the distal connection 222 may include a pair of opposing legs extending on opposite sides of the sheath 203. One of the opposing legs may be configured to engage the first housing portion 207A, and one of the opposing legs (e.g., the opposing legs) may be configured to engage the second housing portion 207B.

[0101] The distal connection 222 can pivotally engage with the intermediate connection 224 at an intermediate pivot point 226 between the distal pivot point 223 and the proximal pivot point 225. The distal pivot point 223 can be fixed axially and / or longitudinally relative to the housing 207. Thus, when the head 276 of the bone punch 270 translates distally to slide the ejector block 221 distally within the housing 207, the proximal end of the distal connection 222 and the distal end of the intermediate connection 224 can be laterally translated relative to the longitudinal axis of the sheath 203, the bone punch 270, and / or the elongated axis 274 by pivoting relative to each other at the intermediate pivot point 226 when the proximal end of the intermediate connection 224 translates distally and / or longitudinally toward the distal end of the distal connection 222 and / or the distal pivot point 223. In some embodiments, the proximal pivot point 225, intermediate pivot point 226, and / or distal pivot point 223 may include one or more pins, shafts, or other elements and / or be defined thereon. Some examples of suitable, but not limiting, materials for the ejector block 221, distal connection 222, intermediate connection 224, and / or its elements or components are described below.

[0102] The distal connection 222 may include a cam surface 227 configured to engage a corresponding surface of the rod 205, wherein the corresponding surface of the rod 205 faces the housing 207, the longitudinal axis of the distal connection 222 and / or the sheath 203, the bone punch 270, and / or the elongated shaft 274. In some embodiments, the cam surface 227 may be curved. In some embodiments, the cam surface 227 may be convex. In some embodiments, the corresponding surface of the rod 205 may be curved. In some embodiments, the corresponding surface of the rod 205 may be convex. In some embodiments, the corresponding surface of the rod 205 may be concave. In some embodiments, the corresponding surface of the rod 205 may be a complex and / or irregular surface having recessed and convex portions. Other configurations are also contemplated.

[0103] As described above, the handle assembly 200 may include a spring 211 disposed within the housing 207. The spring 211 may include a first arm 211A extending proximally from the wound portion and configured to engage the housing 207. In at least some embodiments, the first arm 211A may be configured to engage the first housing portion 207A (not shown). The spring 211 may include a second arm 211B extending distally from the wound portion and configured to engage a rod 205. For example, the rod 205 may include a slot formed therein configured to receive the second arm 211B. In another example, the rod 205 may include one or more holes 206 configured to receive the second arm 211B, such as… Figure 8 As shown.

[0104] Figure 8-10 This is a perspective view of the medical device and handpiece assembly 200 described in this article. Figure 8-10Shown from different angles, in which different elements of the handle assembly 200 are hidden in the view, additional features are shown and / or various interactions between the components are made easier to understand. For example, in some embodiments, a pair of opposing legs of the distal connection 222 may include a first leg 222A and a second leg 222B.

[0105] In some embodiments, the first housing portion 207A may include a groove 202 configured to receive a first arm portion 211A of the spring 211, such as Figure 9 As shown. Other configurations for securing the first arm portion 211A relative to the first housing portion 207A and / or preventing relative movement between them are also conceivable. As described above, the intermediate connection 224 may include a first intermediate connection 224A (not shown) and a second intermediate connection 224B, such as Figure 9 As shown. The first intermediate connection 224A and the second intermediate connection 224B may be similar in form, size and / or shape.

[0106] In some embodiments, the handle assembly 200 may include a second spring 213, such as Figure 10 As shown, the device may include a wound portion, a first arm 213A extending proximally from the wound portion, and a second arm 213B extending distally from the wound portion. In some embodiments, a second intermediate connection 224B (not shown) may include a slot formed therein facing a proximally portion of the distal connection 222 and / or opening inwardly and / or toward the proximally portion of the distal connection 222. The slot formed in the second intermediate connection 224B may be configured to receive the first arm 213A of the second spring 213. The distal connection 222 may include a slot 230 formed in a pair of opposing legs 222B of the distal connection 222, wherein the slot 230 faces the second intermediate connection 224B and / or opens outwardly and / or toward the second intermediate connection 224B. The slot 230 may be configured to receive the second arm 213B of the second spring 213. In some embodiments, at least a portion of the wound portion of the second spring 213 may be received and / or recessed in the proximally portion of the distal connection 222.

[0107] It is readily understood that, when the bone punch 270 is in the second position, rotation of the rod 205 toward the longitudinal axis of the housing 207 and / or sheath 203, the bone punch 270 and / or the elongated shaft 274 (e.g., toward the initial or intermediate position) actuates the linkage 220 to translate the head 276 of the bone punch 270 proximally, thereby retracting the puncture tip 272 into the sheath 203 and / or removing the puncture tip 272 from the patient's bone. The corresponding surface of the rod 205 can apply force to the cam surface 227 of the distal connection 222, thereby laterally pushing and / or translating the proximal portion of the distal connection 222 toward the longitudinal axis of the sheath 203, the bone punch 270 and / or the elongated shaft 274, resulting in corresponding movement of the intermediate connection 224 and proximal translation of the ejector block 221 within the housing 207 until the outwardly extending protrusion 279 re-engages the wall of the housing 207. When the outwardly extending protrusion 279 engages with the wall of the housing 207, the rod 205 is in an initial or intermediate position and is prevented from rotating inward past the initial or intermediate position and / or closer to the housing 207 than the initial or intermediate position, until the outwardly extending protrusion 279 disengages from the wall of the housing 207 by squeezing, pushing, actuating, or otherwise moving the plurality of connecting members 278 inward toward the longitudinal axis and / or elongated axis 274 of the head 276 and / or the bone punch 270. Once the outwardly extending protrusion 279 has disengaged from the wall of the housing 207, the rod 205 may rotate toward the longitudinal axis of the housing 207 and / or the sheath 203, the bone punch 270 and / or the elongated axis 274 toward the disengaged position, as... Figure 11 As shown, this helps to push the bone punch 270 out of the handle assembly 200.

[0108] Spring 211 can be biased toward the initial or intermediate position of rod 205. Therefore, if rod 205 rotates away from the initial or intermediate position, spring 211 can be compressed and a force can be applied to rod 205 to return it to the initial or intermediate position. The initial or intermediate position of rod 205 can be considered the “initial” position of spring 211. Similarly, second spring 213 can be biased toward the disengaged position of rod 205. Therefore, if rod 205 rotates away from the disengaged position, second spring 213 can be compressed and a force can be applied to connecting rod 220 to return rod 205 to the disengaged position. The disengaged position of rod 205 and the corresponding positioning of connecting rod 220 can be considered the “initial” position of second spring 213. Spring 211 can be configured to apply a greater force to rod 205 than the second spring 213 is configured to apply to connecting rod 220. In practice, spring 211 is "stronger" than the second spring 213, so the force exerted by spring 211 can exceed the force exerted by the second spring 213. This relationship also means that the force required to rotate lever 205 from the extended position to the initial or intermediate position and / or the disengaged position is less than the force required to rotate lever 205 from the initial or intermediate position to the extended position. In other cases, handle assembly 200 may be configured such that the second spring 213 can be configured to apply a greater force on the lever than spring 211. If all external forces are removed from handle assembly 200, lever 205 will be biased toward and / or will return to the initial or intermediate position. If bone punch 270 is not present within handle assembly 200, lever 205 will be biased toward and / or will return to the initial or intermediate position.

[0109] In use, the distal end of the sheath 203 can be configured to be positioned adjacent to and / or abut against the surface of the patient's bone. As discussed herein, the medical device can be configured to form one or more holes within the bone. In some embodiments, the distal end of the sheath 203 can be positioned directly against the surface of the bone. In some embodiments, the distal end of the sheath 203 can be positioned against a sheet implant 50, which is positioned directly against the bone surface, for example, as... Figure 12 As shown, this allows one or more holes to also be formed in the sheet-like implant 50. Therefore, as... Figure 12 The presence of a centrally located patch implant 50 can be considered optional.

[0110] After positioning the puncture tip 272 against the bone surface, the user can apply distal force to the head 276 of the bone punch 270, such as using a hammer or other tool, to drive the puncture tip 272 into the bone. Figure 12As shown. In some embodiments, optionally, the sheath 203 may include a position holding member 204 extending distally therefrom, wherein the position holding member 204 is configured to extend into one or more holes formed in the bone as the puncture tip 272 is driven distally into the bone. Subsequently, as the rod 205 rotates toward the housing 207 to withdraw the puncture tip 272 from the bone, the position holding member 204 may remain positioned within one or more holes to maintain the position of the sheath 203 and / or the handle assembly 200 relative to one or more holes, as... Figure 13 As shown.

[0111] In some embodiments, after the bone punch 270 is detached from the housing 207 and / or after the bone punch 270 is removed from the handle assembly 200, the user can insert the nail delivery insert 600 (such as...) Figure 14 (As shown) Inserted into the sheath 203 of the handle assembly 200. The nail delivery insert 600 may include a shaft 602, a proximal head 604, and a distal end 606. The nail delivery insert 600 may have an arm 608 connected to the distal end 606, which may hold a bone nail, such as bone nail 100, as shown. Figure 15 More detailed illustration and description are provided. In some examples, arm 608 may be designed to receive into cavities 128A, 128B of the bone screw 100 and retain the screw 100 by friction. Once the screw delivery insert 600 is received within the sheath 203, the user may apply a force to the proximal end of the screw delivery insert 600. The applied force may drive arm 610 of the screw delivery insert 600, together with the bone screw 100, into one or more holes formed in the bone. Natural movement of tissue and / or bone, and / or pull-out force applied to the bridging element of the bone screw 100, may serve to secure the bone screw 100 within the bone.

[0112] The user can then remove the nail delivery insert 600 from the handle assembly 200. A retaining force can be applied to the bone screw 100 sufficient to overcome the friction between the arm 608 of the nail delivery insert 600 and the bone screw 100, allowing the nail delivery insert 600 to be removed from the bone while the bone screw 100 remains in the bone. Finally, the user can then retrieve the handle assembly 200 from the patient and complete the procedure.

[0113] Figure 15 An example bone screw 100 is shown that can be used with the medical device described herein. Although the various parts of the example bone screw 100 are depicted to scale relative to the other parts of the bone screw 100, other configurations of the size and orientation of the various parts are contemplated in other examples. Figure 15 Arrows are used to indicate multiple reference directions to help understand the details of the bone screw 100. The directions shown include: proximal direction P, distal direction D, first lateral outward direction LOA, second lateral outward direction LOB, first lateral inward direction LIA, and second lateral inward direction LIB.

[0114] In some examples, the bone screw 100 includes a first arm 102A, a second arm 102B, and a bridging member 104. The bridging member 104 may be adjacent to or extend from the proximal end of the first arm 102A to the proximal end of the second arm 102B. The first arm 102A may include a first trunk 106A, which typically has a wider width than the rest of the first arm 102A, such as... Figure 15 As shown. In some examples, the first arm 102A may also include a non-main trunk portion 105A. In different examples, the length of the first main trunk 106A may vary relative to the total length of the first arm 102A. For example, the first main trunk 106A may extend the entire length of the first arm 102A such that the bridging member 104 is close to or adjacent to the first main trunk 106A. In other examples, the first arm 102A may not include the first main trunk 106A. That is, the first arm 102A may not have a portion wider than the rest of the first arm 102A. In such examples, the first arm 102A may still have a non-main trunk portion 105A.

[0115] Similarly, the second arm 102B may include a second trunk 106B, which typically has a wider width than the remainder of the second arm 102B. Furthermore, the second trunk 106B may extend at least a portion of the second arm 102B. The distal portion of the second arm 102B may be adjacent to the proximal end of the second trunk 106B, and in some embodiments, the second arm 102B may also include a non-trunk portion similar to the non-trunk portion 105A. Like the first trunk 106A, the second trunk 106B may extend along the second arm 102B for varying lengths. Additionally, in some examples, the second arm 102B may not have a portion with a wider width than the remainder of the second arm 102B. Figure 15 In the diagram, the first trunk 106A and the second trunk 106B are shown extending distally from the proximal portions of the first arm 102A and the second arm 102B, respectively.

[0116] exist Figure 15 In the example, the first main trunk 106A has a lateral extension or cross-sectional area greater than the lateral extension of the non-main trunk portion 105A of the first arm 102A and the lateral extension of the bridging member 104. The bone screw 100 may have a first variation in lateral stiffness 108A, disposed at the distal end of the non-main trunk portion 105A of the first arm 102A immediately adjacent to the first main trunk 106A. As depicted, the change in stiffness is abrupt, but in alternative examples it may be gradual, for example, through a gradual change in the lateral extent between the first main trunk 106A and the non-main trunk portion 105A. In the example where the first main trunk 106A extends the entire length of the first arm 102A, the stiffness variation may occur at the location of the first main trunk 106A immediately adjacent to the bridging member 104. (Refer to...) Figure 15It should be understood that the first main trunk 106A is eccentrically mounted to the first arm 102A, and the second main trunk 106B is eccentrically mounted to the second arm 102B. Like the first main trunk 106A, the lateral extent or cross-sectional area of ​​the second main trunk 106B is greater than the lateral extent of the non-main trunk portion 105B of the second arm 102B and the bridging member 104. The bone screw 100 may include a second variation in lateral stiffness 108B at the distal end of the non-main trunk portion 105B of the second arm 102B immediately adjacent to the second main trunk 106B. Similar to the first arm 102A, in some examples, the change in stiffness may be abrupt or gradual. If the second main trunk 106B extends over the entire length of the second arm 102B, the change in stiffness may occur at the adjoining point with the bridging member 104. In an additional example where the lateral range between the first and second main trunks 106A and 106B and between the first and second arms 102A and 102B may remain unchanged, the change in stiffness can be achieved by using different materials for the first and second main trunks 106A and 106B and the first and second arms 102A and 102B.

[0117] Some examples of the bone screw 100 may include at least a first protrusion 122A and a second protrusion 122B on a first trunk 106A, and a third protrusion 122C and a fourth protrusion 122D on a second trunk 106B. The first and third protrusions 122A and 122C on the first and second trunks 106A and 106B, respectively, may also include a first proximal surface 124A and a third proximal surface 124C extending away from their respective trunks along a first direction, for example, outward and away from each opposing trunk 106A and 106B. The first direction may be such that the first and third proximal surfaces 124A and 124C will engage with the trunk through the natural movement of the tissue or bone after it has been inserted into the tissue or bone. In some examples, a pull-out force may be applied to the bridging member 104 to further engage the first and third proximal surfaces 124A and 124C with the bone or tissue. The natural movement or pull-out force of the bone or tissue generates a first moment immediately adjacent to each trunk, centered on the area of ​​reduced stiffness, tending to rotate each trunk about it. This rotation of each trunk can further provide greater retention force to the bone screw 100 in the bone or tissue. The second protrusion 122B and the fourth protrusion 122D on the first and second trunks 106A and 106B, respectively, may each include a second proximal surface 124B and a fourth proximal surface 124D extending away from their respective trunks in a second direction different from the first direction (e.g., inward, toward the opposing trunk). For example, the second direction may be chosen such that the second and fourth proximal surfaces 124B, 124D will engage the tissue or bone by the natural movement of the tissue or bone after each trunk is inserted into the tissue or bone. In some examples, a pull-out force may be applied to the bridging member 104. A weak region is provided in each main trunk adjacent to the slits or reduced cross-sections of the second and fourth protrusions 122B, 122D, such that a second torque is applied to the main trunk in response to the natural movement of tissue or bone and / or the pull-out force on the bridging member 104. This torque causes the main trunk to rotate about the weak region and increases the retention force of the bone screw 100.

[0118] like Figure 15 As shown in the example of the bone screw 100, the first trunk 106A includes a first protrusion 122A disposed on the outer side of the first trunk 106A and a second protrusion 122B disposed on the inner side of the first trunk 106A. The first protrusion 122A includes a first proximal surface 124A extending away from the first trunk 106A along a first direction. (Reference) Figure 15It should be understood that the first direction has an outward lateral component and a proximal component, such that the first proximal surface 124A extends outward and proximally away from the first trunk 106A. For example, the first direction may be selected such that the first proximal surface 124A, after insertion, engages tissue or bone adjacent to the outer side of the first trunk 106A, thereby applying a first torque to the first trunk 106A in response to the natural movement of the tissue or bone and / or the pull-out force on the bridging member 104. The torque is concentrated on the less stiff arm adjacent to the first protrusion 122A.

[0119] exist Figure 15 In this example, the first trunk 106A includes a first localized weak region 120A located near the second protrusion 122B. The second protrusion 122B includes a second proximal surface 124B extending away from the first trunk 106A in a second direction. The second direction is chosen such that the second proximal surface 124B, upon insertion, engages tissue or bone close to the medial side of the first trunk 106A, thereby applying a second torque to the first trunk 106A in response to natural movement of the tissue or bone and / or pull-out forces on the bridging member 104. The torque is concentrated around the first localized weak region 120A. The second torque has a direction substantially opposite to that of the first torque. It should be understood that the second direction has an inward lateral component and a proximal component, such that the second proximal surface 124B extends inward and proximally away from the first trunk 106A. In other examples, the first arm 102A may not include the second protrusion 122B. In such an example, in response to the natural movement of tissue or bone and / or the pull-out force on the bridging member 104, only the first torque may be applied to the first trunk 106A.

[0120] The second main trunk 106B includes a third protrusion 122C disposed on the outer side of the second main trunk 106B and a fourth protrusion 122D disposed on the inner side of the second main trunk 106B. Figure 15 In the example, the third protrusion 122C includes a third proximal surface 124C extending along a third direction away from the second trunk 106B. (See reference...) Figure 15 It should be understood that the third orientation has an outward lateral component and a proximal component, such that the third proximal surface 124C extends outward and proximally away from the second trunk 106B. The third orientation is selected such that the third proximal surface 124C, when inserted therein, will engage tissue or bone adjacent to the outer side of the second trunk 106B, thereby applying a third torque to the second trunk 106B in response to the natural movement of the tissue or bone and / or the pull-out force on the bridging member 104.

[0121] exist Figure 15 In the example, the second main trunk 106B includes a second local weak region 120B located near the fourth protrusion 122D. The fourth protrusion 122D includes a fourth proximal surface 124D extending in a fourth direction away from the second main trunk 106B. Figure 15 In one example, a fourth direction is chosen such that the second proximal surface 124B, upon insertion, engages tissue or bone close to the inner side of the second trunk 106B, thereby applying a fourth torque to the second trunk 106B in response to natural movement of the tissue or bone and / or pull-out force on the bridging member 104. The direction of the fourth torque is generally opposite to the direction of the third torque. It should be understood that the fourth direction has an inward lateral component and a proximal component, such that the fourth proximal surface 124D extends inward and proximally away from the second trunk 106B. In other examples, the second arm 102B may not include the fourth projection 122D. In such examples, only the first torque can be applied to the second trunk 106B in response to natural movement of the tissue or bone and / or pull-out force on the bridging member 104.

[0122] In some embodiments, the bone screw 100 includes a proximal protrusion extending outward from or away from the bridging member 104, while a distal protrusion extends inward or toward the center of the bridging member 104. This generates substantially opposite forces in response to tension on the bridging member 104, which, combined with the weak area or reduced lateral extent, significantly increases the retention force of the bone screw 100 in the bone, as different portions of the trunk tend to rotate in opposite directions and exert forces on opposing walls in the hole in which the bone screw 100 is positioned. However, it should be understood that other configurations of the protrusions are possible. In some examples, only two protrusions are included, and they extend in different directions to cause different force responses when tension is applied to the bridging member 104. Other examples may include different numbers of protrusions generating one or more moments in each of the first and second arms 102A, 102B.

[0123] In some examples, each protrusion of the bone screw 100 can split to form multiple points for better retention within the tissue or bone. Figure 15 In the example, the first protrusion 122A of the first main trunk 106A defines a first notch 126A that divides the first protrusion 122A into a first sub-protrusion and a second sub-protrusion. The second protrusion 122B of the second main trunk 106B defines a second notch 126B. Figure 15 In the example, the second notch 126B divides the second protrusion 122B into a first sub-protrusion and a second sub-protrusion. The third protrusion 122C of the second main trunk 106B defines the third notch 126C, which divides the third protrusion 122C into a first sub-protrusion and a second sub-protrusion. The fourth protrusion 122D of the second main trunk 106B defines the fourth notch 126D, which divides the fourth protrusion 122D into a first sub-protrusion and a second sub-protrusion.

[0124] Continue to refer to Figure 15A first trunk 106A defines a first cavity 128A, and a second trunk 106B defines a second cavity 128B. The first cavity 128A extends into the first trunk 106A, and the second cavity 128B extends into the second trunk 106B. The first cavity 128A and the second cavity 128B are dimensioned to mate with a nail delivery insert 600 for retaining and inserting a nail into tissue or bone. In summary, the nail delivery insert 600 includes longitudinally extending posts that mate within the first and second cavities 128A, 128B to retain the bone nail 100 and push the bone nail 100 into the appropriate position in the tissue or bone when the posts are close to a portion of their respective trunks. In some examples, the cavities may extend through a portion of the length of each trunk, and the distal end of the bone nail 100 is closed. Alternatively, the first cavity 128A and the second cavity 128B may extend through the entire length of the first trunk 106A and the second trunk 106B, respectively, or through other portions of the bone nail 100 in some examples. In some embodiments, the first cavity 128A and the second cavity 128B each have a generally rectangular or square cross-sectional shape to mate with a similar cross-sectional shape on the nail delivery insert 600. However, the first cavity 128A and the second cavity 128B may have various cross-sectional shapes to mate with alternative nail delivery insert designs without departing from the spirit and scope of this disclosure.

[0125] Figure 16 An alternative medical device is shown that can be used to form one or more holes in a patient's bone (e.g., the humerus 14) to facilitate the placement of one or more bone screws 100 and / or to secure a sheet implant 50 to the bone. In some embodiments, the medical device may include a bone punch 370, which includes gear teeth 375 extending outwardly therefrom (e.g., Figure 17-18 The slender shaft 374, the head 376 located at the proximal end of the slender shaft 374, and the puncture tip 372 located at the distal end of the slender shaft 374, are compatible with... Figure 3 The bone punch 270 shown is similarly formed. In some embodiments, the bone punch 370 and / or the puncture tip 372 may include a plurality of puncture tips, two or more puncture tips, a pair of puncture tips, etc., extending distally from the distal end of the elongated shaft 374. The puncture tip 372 may be configured to be driven into bone (e.g., humerus 14). In some embodiments, the puncture tip 372 may be a spike, a point, a spear, or other suitable shape. Thus, the puncture tip 372 may include a sharp distal end and / or a tapered distal portion configured to engage and / or penetrate bone.

[0126] Although the simpler version of the Bone Punch 370 (especially the Head 376) is in Figure 16-18As shown, the bone punch 370 is envisioned to include some, many, and / or all of the same features shown in the bone punch 270 disclosed herein. For example, although not explicitly shown, in some embodiments, the head 376 of the bone punch 370 may include a plurality of connecting members, and each of the plurality of connecting members may include an outwardly extending projection, as in the bone punch 270 disclosed herein. In some embodiments, the plurality of connecting members may be fixedly attached to opposite sides of the head 376. The plurality of connecting members may extend distally from the head 376 toward the distal end of the elongated axis 374. The plurality of connecting members may extend laterally outward from the head 376 at an angle to the longitudinal axis and / or the elongated axis 374 of the bone punch 370. In some embodiments, the plurality of connecting members may be laterally outwardly biased from the head 376. The function of the bone punch 370 may be similar to that of the bone punch 270 in which similar elements are disposed.

[0127] The head 376 of the bone punch 370 may include and / or define a distal surface 377. The distal surface 377 may be a distally facing surface, but is not necessarily the most distal surface of the head 376. For example, the distal surface 377 may be located between the proximal and distal ends of the head 376. In some embodiments, the head 376 may include one or more lateral protrusions. In some embodiments, one or more lateral protrusions may be located between a plurality of connecting members and / or between the proximal and distal ends of the head 376. In some embodiments, one or more lateral protrusions may each and / or collectively define the distal surface 377 of the head 376.

[0128] In some embodiments, the proximal end of the elongated shaft 374 may extend into the head 376 of the bone punch 370. In some embodiments, the proximal end of the elongated shaft 374 may be fixedly attached to the head 376. In some embodiments, the elongated shaft 374 may be integrally formed with the head 376, for example by casting, molding, or machining. Other configurations are also contemplated. Similarly, the proximal end of the puncture tip 372 may extend into the distal end of the elongated shaft 374. The proximal end of the puncture tip 372 may be fixedly attached to the elongated shaft 374. In some embodiments, the puncture tip 372 may be integrally formed with the elongated shaft 374, for example by casting, molding, or machining. Other configurations are also contemplated. Some examples of suitable, but not limiting, materials for the bone punch 370 and / or its elements or components are described below.

[0129] Figure 16The illustrated medical device may include a handle assembly 300 comprising a housing 307, a rod 305 rotatably coupled to the housing 307, and a sheath 303 extending distally from the housing 307. In at least some embodiments, the proximal end of the sheath 303 may be fixedly attached to the housing 307. The sheath 303 may extend into and / or within the housing 307 such that the proximal end of the sheath 303 is disposed within the distal portion of the housing 307, and the sheath 303 is within the housing 307 and extends distally from the distal end of the housing 307. Examples of suitable, but not limiting, materials for the housing 307, rod 305, sheath 303, and / or its elements or components are described below.

[0130] The housing 307 can be formed as a multi-piece structure, including... Figure 16 The first outer casing portion 307A visible in the middle and in Figure 16 The second housing portion 307B is not visible in the diagram. For illustrative purposes, one of the first housing portion 307A or the second housing portion 307B may be hidden in the view to allow viewing of its internal components and / or features. The first housing portion 307A and the second housing portion 307B may be assembled together to form housing 307. In the illustrated example, fasteners such as screws and nuts may be used to assemble housing 307. However, other components and / or attachment devices may also be used, including but not limited to snap-fit ​​engagements, friction engagements, pins, rivets, etc. In some embodiments, once housing 307 is assembled, any known suitable means may be considered and / or used to make such assembly permanent, such as, but not limited to, adhesives, welding, etc.

[0131] The medical device may include the bone punch 370 described herein. The bone punch 370 may be disposed within and / or extend through a sheath 303. An elongated shaft 374 may be slidably disposed in a first position within the sheath 303 when the rod 305 is in its initial position, for example… Figure 16 As seen in [the document]. In some embodiments, the head 376 of the bone punch 370 may be releasably engaged with the housing 307, as described herein. In some embodiments, the head 376 of the bone punch 370 may be spaced apart from the proximal surface 308 of the housing 307 in a first position. The puncture tip 372 may be positioned near the distal end of the sheath 303 in the first position. In some embodiments, the puncture tip 372 may be disposed within the distal end of the sheath 303 in the first position. In some embodiments, a portion of the puncture tip 372 may extend distally from the distal end of the sheath 303 in the first position to aid in positioning the medical device at the treatment site (e.g., to engage the surface of bone). In some embodiments, less than 10% of the puncture tip 372 extends distally from the distal end of the sheath 303 in the first position. In some embodiments, less than 5% of the puncture tip 372 extends distally from the distal end of the sheath 303 in the first position.

[0132] Figure 17 A medical device is shown in which a first housing portion 307A of a handle assembly 300 is removed, and a second housing portion 307B is visible. The housing 307 may include a leg extending laterally from its distal portion. In some embodiments, the leg may be located at and / or extend laterally from the distal end of the housing 307. A rod 305 may be rotatably and / or pivotally coupled to the housing 307 about a rotation axis. In some embodiments, the handle assembly 300 may include a spring biasing the rod 305 toward an initial position.

[0133] exist Figure 17 In the diagram, rod 305 is shown positioned in an initial position. In the initial position, rod 305 may engage with the outer surface of housing 307. In the initial position, the distal end 309 of rod 305 may be substantially aligned with and / or disposed within the free end of the outrigger. In the initial position, rod 305 may extend distally toward the distal end of housing 303 and / or handle assembly 300 relative to the longitudinal axis of sheath 303. For example, the first angle may be less than about 15 degrees, less than about 10 degrees, less than about 5 degrees, about 0 degrees, or another small tilt angle. In some embodiments, in the initial position, rod 305 may extend substantially parallel to the longitudinal axis of sheath 303 toward the distal end of sheath 303. In at least some embodiments, from the initial position, rod 305 may be configured to rotate the distal end 309 of rod 305 toward or away from housing 307.

[0134] exist Figure 17 In the diagram, the bone punch 370 is shown positioned in a first position. When the lever 305 is in the initial position, the elongated shaft 374 of the bone punch 370 is slidably disposed within the sheath 303 of the handle assembly 300. In the first position and / or when the lever 305 is in the initial position, the distal surface 377 of the head 376 of the bone punch 370 may be spaced apart from the proximal surface 308 of the housing 307 of the handle assembly 300. In some embodiments, in the first position and / or when the lever 305 is in the initial position, the head 376 of the bone punch 370 may be releasably engaged with the housing 307 of the handle assembly 300. For example, a plurality of connecting members and their outwardly extending protrusions may engage the housing 307 to define a wall of the proximal surface 308 of the housing 307. In some embodiments, the proximal surface 308 may be a surface of the housing 307 located on and / or near the proximal end of the housing 307. In some embodiments, the proximal surface 308 may be the nearest side surface of the housing 307.

[0135] In a first position, the outwardly extending protrusion may extend laterally outward from the longitudinal axis and / or elongated axis 374 of the head 376 and / or the bone punch 370 beyond the periphery of the opening in the wall of the housing 307 (in which the head 376 is disposed). If present, the outwardly extending protrusion may prevent the head 376 and / or the bone punch 370 from being removed from the housing 307 until multiple connecting members are squeezed, pushed, actuated, or otherwise moved inward toward the longitudinal axis and / or elongated axis 374 of the head 376 and / or the bone punch 370, thereby separating the outwardly extending protrusion from the wall of the housing 307 by translating it inward until it is disposed within and / or inward of the periphery of the opening. This will allow the multiple connecting members and the outwardly extending protrusion to pass through the opening in the wall of the housing 307. In the first position, the distal surface 377 of the head 376 may separate proximally from the proximal surface 308 of the wall of the housing 307.

[0136] like Figure 17 As shown, the bone punch 370 may include an elongated shaft 374 having gear teeth 375 extending outwardly therefrom. The gear teeth 375 may be disposed between a distal end of the elongated shaft 374 and a head 376. In some embodiments, the gear teeth 375 may be spaced apart from the head 376. In some embodiments, the elongated shaft 374 may include a ridge 373 extending radially outwardly from the elongated shaft 374, wherein the ridge 373 is circumferentially and / or axially aligned with the gear teeth 375. In some embodiments, the ridge 373 spaces the head 376 from the gear teeth 375. In some embodiments, the gear teeth 375 may be formed from the ridge 373 and / or formed by removing material from the ridge 373. In some embodiments, the ridge 373 and the gear teeth 375 may be integrally formed together. The ridge 373 and the gear teeth 375 may be fixedly attached to the elongated shaft 374. In some embodiments, the ridge 373 and / or gear teeth 375 may be formed together with the elongated shaft 374 as a single integral structure.

[0137] In some embodiments, the sheath 303 may include a slot 304 formed therein and / or through a sidewall of the sheath 303 to receive gear teeth 375 and / or ridges 373. The slot 304 may extend longitudinally from the proximal end of the sheath 303 along a proximal portion of the sheath 303 in a distal direction. In some embodiments, the slot 304 may be oriented to face the rod 305.

[0138] In some embodiments, the handle assembly 300 may include a plurality of gears 380 disposed within the housing 307. At least one of the plurality of gears 380 may be configured to engage with gear teeth 375 of an elongated shaft 374. Figure 17As can be seen, the gear teeth 375 of the bone punch 370 can engage at least one of a plurality of gears 380 in a first position. The plurality of gears 380 can be rotatably engaged with and / or coupled to the housing 307. The plurality of gears 380 may include a first gear 382 configured to engage the gear teeth 375 of the elongated shaft 374, a second gear 384 fixedly fixed to the rod 305, and a third gear rotatably meshing with the first gear 382 and the second gear 384. Other configurations are also contemplated.

[0139] The distal translation of the bone punch 370 within the sheath 303 and / or the distal translation of the head 376 of the bone punch 370 relative to the housing 307 from a first position to a second position distal to the first position can cause multiple gears 380 to rotate the distal end 309 of the rod 305 away from the housing 307 and / or away from the longitudinal axis and / or the elongated shaft 374 of the bone punch 370 to an extended position, such as... Figure 18 As shown. In the extended position, the rod 305 can extend at a second angle relative to the longitudinal axis of the sheath 303 toward the distal end of the sheath 303 and / or the handle assembly 300. In some embodiments, the second angle can be an oblique angle. The second angle can be greater than the first angle.

[0140] like Figure 18 As shown, the distal surface 377 of the head 376 of the bone punch 370 may engage and / or be adjacent to the proximal surface 308 of the housing 307 in a second position. In the second position, an outwardly extending protrusion (if present) may be spaced distally from the wall of the housing 307 that defines the proximal surface 308. In this case, the outwardly extending protrusion may extend laterally outward from the longitudinal axis and / or elongated axis 374 of the head 376 and / or the bone punch 370 beyond the periphery of the opening in the wall of the housing 307 (in which the head 376 is disposed), thereby preventing the bone punch 370 from being accidentally removed from the handle assembly 300.

[0141] In the second position, as the elongated shaft 374 translates distally within the sheath 303, the puncture tip 372 can extend from the distal end of the sheath 303. The distal end of the sheath 303 can be configured to be positioned adjacent to the bone surface, similar to the above description of sheath 203 and... Figure 12The discussion continues. As the bone punch 370 is translated distally to the second position, the puncture tip 232 can be driven into the bone to form one or more holes. There may be a direct or indirect correlation between the rotational position of the lever 305 relative to the housing 307 and the depth of the puncture tip 372 within the bone. As the lever 305 rotates further away from the housing 307 and / or as the angle between the lever 305 and the longitudinal axis of the sheath 303 and / or the bone punch 370 increases, the puncture tip 372 can extend further distally from the distal end of the sheath 303 and / or can be driven deeper into the bone. The user of the medical device and / or handle assembly 300 can use the rotational position of the lever 305 relative to the longitudinal axis of the housing 307 and / or the sheath 303 and / or the bone punch 370 to indicate the depth of the puncture tip 372 within the bone, thereby providing the user with a visual cue regarding the status of the procedure.

[0142] Subsequently, rod 305 extends from its extended position (e.g.) Figure 18 ) to the initial position (e.g. Figure 17 Rotation can generate a proximal force on the bone punch 370 sufficient to overcome the cortical elasticity of the bone (which "squeezes" or "pinches" the puncture tip 372) to pull the puncture tip 372 out of the bone. Therefore, the rod 305 moves from the extended position (e.g., Figure 18 ) to the initial position (e.g., Figure 17 Rotation allows the bone punch 370 to be translated proximally, thereby removing the puncture tip 372 from the bone, leaving one or more holes formed in the bone. Multiple gears 380 provide a mechanical advantage in generating the force required to pull the puncture tip 372 from the bone, thus reducing the force the user needs to apply to the lever 305. Rotating the lever 305 from the extended position to the initial position translates the bone punch 370 back from the second position to the first position. Thereafter, if necessary, the bone punch 370 can be removed from the handle assembly 300, or the medical device can be removed from the treatment site.

[0143] In use, the distal end of the sheath 303 can be configured to be positioned adjacent to and / or against the patient's bone surface. As discussed herein, the medical device can be configured to form one or more holes within the bone. In some embodiments, the distal end of the sheath 303 can be positioned directly against the bone surface. In some embodiments, the distal end of the sheath 303 can be positioned with respect to a sheet implant 50, which is positioned directly against the bone surface, for example, similar to... Figure 12 The sheath 203 shown allows one or more holes to also be formed in the sheet implant 50. Therefore, the presence of the sheet implant 50 can be considered optional.

[0144] After positioning the puncture tip 372 against the bone surface, the user may apply a distal force to the head 376 of the bone punch 370, such as with a hammer or other tool, to drive the puncture tip 372 into the bone. In some embodiments, the sheath 303 may optionally include a position-holding member extending distally therefrom (e.g., as shown in the image). Figure 12 The position holding member 204 (as seen in the diagram) is configured to extend into one or more holes formed in the bone as the puncture tip 372 is driven distally into the bone. Subsequently, as the rod 305 rotates toward the housing 307 to withdraw the puncture tip 372 from the bone, the position holding member can remain positioned within one or more holes to maintain the position of the sheath 303 and / or handle assembly 300 relative to one or more holes, for example, similar to... Figure 13 The configuration shown.

[0145] In some embodiments, after separating the bone punch 370 from the housing 307 and / or after removing the bone punch 370 from the handle assembly 300, the user can... Figure 14 The nail delivery insert 600 shown is inserted into the sheath 303 of the handle assembly 300. The nail delivery insert 600 may include a shaft 602, a proximal head 604, and a distal end 606. The nail delivery insert 600 may have an arm 608 connected to the distal end 606, which can hold the bone nail, as shown herein. Figure 15 A bone screw 100 is shown and described. In some examples, an arm 608 may be designed to receive into cavities 128A, 128B of the bone screw 100 and retain the bone screw 100 by friction. Once the screw delivery insert 600 is received within the sheath 303, a user may apply a force to the proximal end of the screw delivery insert 600. The applied force may drive the arm 610 of the screw delivery insert 600 and the bone screw 100 into one or more holes formed in the bone. Natural movement of tissue and / or bone, and / or pull-out force applied to the bridging element of the bone screw 100 may serve to secure the bone screw 100 within the bone.

[0146] The user can then remove the nail delivery insert 600 from the handle assembly 300. A retaining force can be applied to the bone screw 100 sufficient to overcome the friction between the arm 608 of the nail delivery insert 600 and the bone screw 100, allowing the nail delivery insert 600 to be removed from the bone while the bone screw 100 remains in the bone. Finally, the user can then retract the handle assembly 300 from the patient and complete the procedure.

[0147] Figure 19 It shows a device that can be used with alternative medical devices 400 (e.g., Figure 20Alternative configurations of the bone punch 470 used together will be described in more detail below. The bone punch 470 may include an elongated shaft 474, a head 476 disposed proximally to the elongated shaft 474, and a puncture tip 472 disposed distally to the elongated shaft 474, for example... Figure 19 As shown. In some embodiments, the bone punch 470 and / or puncture tip 472 may include a plurality of puncture tips, two or more puncture tips, a pair of puncture tips, etc., extending distally from the distal end 475 of the elongated shaft 474. The puncture tip 472 may be configured to be driven into bone (e.g., humerus 14). In some embodiments, the puncture tip 472 may be a spike, a point, a spear, or other suitable shape. Thus, the puncture tip 472 may include a sharp distal end and / or a tapered distal portion configured to engage and / or penetrate bone.

[0148] In some embodiments, the head 476 may include one or more lateral protrusions. In some embodiments, the one or more lateral protrusions may be disposed between the proximal end and the distal end of the head 476. The one or more lateral protrusions may each and / or collectively define a distal surface 477 of the head 476. The distal surface 477 may be a distally facing surface, but is not necessarily the most distal surface of the head 476. For example, the distal surface 477 may be disposed between the proximal end and the distal end of the head 476. In at least some embodiments, the head 476 of the bone punch 470 may include one or more magnets 473 disposed therein. In some embodiments, the one or more magnets 473, which are described in more detail herein, may be fixedly attached to the head 476 using one or more of a variety of attachment methods, such as, but not limited to, adhesives, interference fits, friction fits, welding, co-molding, injection molding, etc. In some embodiments, the one or more magnets 473 may be embedded within the head 476. In some embodiments, at least a portion of the one or more magnets 473 may be exposed outside the head 476, for example, exposed at the distally facing surface of the head 476. In some embodiments, one or more magnets 473 may be completely embedded within the head 476 such that none of the one or more magnets 473 are exposed to the outside of the head 476.

[0149] like Figure 19AAs shown, the head 476 may include a plurality of magnets 473 equidistant from the central longitudinal axis of the bone punch 470, such that the magnets are arranged symmetrically about the central longitudinal axis. Therefore, when the head 476 of the bone punch 470 is in any of a plurality of rotational orientations, the magnets may be arranged in the same orientation as the central longitudinal axis. For example, the head 476 may include a first magnet 473 and a second magnet 473 radially opposite to the first magnet 473, such that when the head 476 of the bone punch 470 is in a first rotational orientation about the central longitudinal axis, the first magnet 473 is in a first position and the second magnet 473 is in a second position, and when the head 476 of the bone punch 470 is in a second rotational orientation about the central longitudinal axis, the first magnet 473 is in the second position and the second magnet 473 is in the first position. For example, the first rotational orientation may be 180 degrees from the second orientation.

[0150] In some embodiments, the proximal end of the elongated shaft 474 may extend into the head 476 of the bone punch 470. In some embodiments, the proximal end of the elongated shaft 474 may be securely attached to the head 476. In some embodiments, the elongated shaft 474 may be integrally formed with the head 476, for example by casting, molding, or machining. Other configurations are also contemplated. Similarly, the proximal end of the puncture tip 472 may extend into the distal end 475 of the elongated shaft 474. The proximal end of the puncture tip 472 may be securely attached to the elongated shaft 474. In some embodiments, the puncture tip 472 may be integrally formed with the elongated shaft 474, for example, by casting, molding, or machining. Other configurations are also contemplated. Some examples of suitable, but not limiting, materials for the bone punch 470 and / or its elements or components are described below.

[0151] Figure 20 A side view illustrates various aspects of an alternative medical device configured to form one or more holes within a patient's bone. The medical device may include a handle assembly 400, which includes a housing 407, a rod rotatably coupled to the housing 407, and a sheath 403 extending distally from the housing 407. In at least some embodiments, the proximal end of the sheath 403 may be fixedly attached to the housing 407. The sheath 403 may extend into and / or within the housing 407 such that the proximal end of the sheath 403 is disposed within the housing 407, and the sheath 403 extends distally from the distal end of the housing 407. Several examples of suitable, but not limiting, materials for the housing 407, rod 405, sheath 403, and / or its elements or assemblies are described below.

[0152] The housing 407 may be formed to include Figure 20 The first outer casing portion 407A visible in the middle and in Figure 20The second housing portion 407B is a multi-piece structure not visible in the diagram. For illustrative purposes, one of the first housing portion 407A or the second housing portion 407B may be hidden in the view to allow viewing of its internal components and / or features. The first housing portion 407A and the second housing portion 407B can be assembled together to form housing 407. In the illustrated example, fasteners such as screws and nuts may be used to assemble housing 407. However, other components and / or attachment devices may also be used, including but not limited to snap-fit ​​engagements, friction engagements, pins, rivets, etc. In some embodiments, once housing 407 is assembled, any known suitable means may be considered and / or used to make such assembly permanent, such as, but not limited to, adhesives, welding, etc.

[0153] The medical device may include the bone punch 470 described herein. In some embodiments, the medical device may include bone punch 270 and / or bone punch 370 described herein, instead of bone punch 470. For brevity, the description relating to the medical device 400 will be limited to bone punch 470, but it will be understood that other configurations are possible and contemplated. Bone punch 470 may be disposed within and / or extend through sheath 403. The head 476 of bone punch 470 may releasably engage with housing 407 in a first position, such as Figure 20-21 As shown. The puncture tip 472 may be positioned near the distal end of the sheath 403 in the first position. In some embodiments, the puncture tip 472 may be disposed within the distal end of the sheath 403 in the first position. In some embodiments, a portion of the puncture tip 472 may extend distally from the distal end of the sheath 403 in the first position to aid in positioning the medical device at the treatment site (e.g., to engage the surface of bone). In some embodiments, less than 50% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position. In some embodiments, less than 40% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position. In some embodiments, less than 30% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position. In some embodiments, less than 20% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position. In some embodiments, less than 10% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position. In some embodiments, less than 5% of the puncture tip 472 extends distally from the distal end of the sheath 403 in the first position.

[0154] Figure 21A medical device is shown in which a first housing portion 407A of a handle assembly 400 is removed and a second housing portion 407B is visible. A lever 405 may be rotatably and / or pivotally coupled to the housing 407 about a rotation axis. The handle assembly 400 may include a spring 411 that biases the lever 405 toward an initial position, such as an intermediate position. In at least some embodiments, the spring 411 may include a winding portion arranged about and / or coaxial with the rotation axis of the lever 405.

[0155] exist Figure 21 In this embodiment, lever 405 is shown positioned in an initial or intermediate position. In at least some embodiments, from the initial or intermediate position, lever 405 may be configured to rotate its distal end 409 toward or away from housing 407. In the initial or intermediate position, lever 405 may extend distally toward the distal end of housing 403 and / or handle assembly 400 relative to the longitudinal axis of housing 403. For example, the first angle may be less than about 15 degrees, less than about 10 degrees, less than about 5 degrees, about 0 degrees, or another small bevel angle. In some embodiments, in the initial or intermediate position, lever 405 may extend substantially parallel to the longitudinal axis of housing 403 toward the distal end of housing 403.

[0156] exist Figure 21 In the diagram, the bone punch 470 is shown positioned in a first position. When the lever 405 is in an initial or intermediate position, the elongated shaft 474 of the bone punch 470 is slidably disposed within the sheath 403 of the handle assembly 400. In some embodiments, at least a portion of the head 476 is configured to engage and / or pass through the wall of the housing 407 that defines the proximal surface 408 of the housing 407. In some embodiments, the proximal surface 408 may be a proximal-facing surface of the housing 407 at and / or near the proximal end of the housing 407. In some embodiments, the proximal surface 408 may be the nearest-side surface of the housing 407. In the first position, the distal surface 477 of the head 476 may be proximally spaced from the proximal surface 408 of the wall of the housing 407.

[0157] In some embodiments, the handle assembly 400 may include a link 420 disposed within the housing 407. Link 420 is similar in form and function to link 220 unless specifically indicated herein, and reference will be made to it. Figure 23 A more detailed description is available. Some additional and / or functional details related to link 420 can be found in the reference. Figure 8-10 This is identified in the described link 220. For example... Figure 21As shown, the head 476 of the bone punch 470 can engage the link 420 in a first position. The link 420 can be pivotally engaged with and / or coupled to the housing 407. The link 420 may include a plurality of elements that can move and / or pivot relative to each other. Distal translation of the bone punch 470 within the sheath 403 and / or translation of the head 476 of the bone punch 470 relative to the housing 407, from the first position to a second position distal to the first position, can cause the link 420 to rotate the distal end 409 of the rod 405 away from the housing 407 and / or away from the longitudinal axis and / or elongated axis 474 of the bone punch 470 to an extended position, such as... Figure 22 As shown. In the extended position, the rod 405 can extend at a second angle relative to the longitudinal axis of the sheath 403 toward the distal end of the sheath 403 and / or the handle assembly 400. In some embodiments, the second angle can be an oblique angle. The second angle can be greater than the first angle.

[0158] like Figure 22 As shown, at least a portion of the head 476 of the bone punch 470 is configured to pass through an opening in the wall and / or the proximal surface 408 of the housing 407 when the bone punch 470 is translated from a first position to a second position. In some embodiments, the distal surface 477 of the head 476 of the bone punch 470 may engage and / or be adjacent to the proximal surface 408 of the housing 407 in the second position. In the second position, as the elongated shaft 474 translates distally within the sheath 403, the puncture tip 472 may extend from the distal end of the sheath 403. The distal end of the sheath 403 may be configured to be adjacent to a surface setting of bone. As the bone punch 470 is translated distally to the second position, the puncture tip 472 may be driven into the bone to form one or more holes in the bone. There may be a direct or indirect correlation between the rotational position of the rod 405 relative to the housing 407 and the depth of the puncture tip 472 within the bone. As the lever 405 rotates away from the housing 407 and / or as the angle between the lever 405 and the longitudinal axis of the sheath 403 and / or the bone punch 470 increases, the puncture tip 472 can extend distally further away from the sheath 403 and / or can be driven deeper into the bone. The user of the medical device and / or handle assembly 400 can use the rotational position of the lever 405 relative to the longitudinal axis of the housing 407 and / or the sheath 403 and / or the bone punch 470 to indicate the depth of the puncture tip 472 within the bone, thus providing the user with visual cues regarding the status of the procedure.

[0159] Subsequently, rod 405 moves from its extended position (e.g., Figure 22 To the initial or intermediate position (e.g., Figure 21 Rotation can generate a proximal force on the bone punch 470 sufficient to overcome the cortical elasticity of the bone (which "squeezes" or "pinches" the puncture tip 472) to remove the puncture tip 472 from the bone. Therefore, the rod 405 moves from the extended position (e.g., Figure 22To the initial or intermediate position (e.g., Figure 21 Rotation allows the bone punch 470 to be translated proximally, thereby removing the puncture tip 472 from the bone, leaving one or more holes formed in the bone. The linkage 420 provides a mechanical advantage in generating the force required to remove the puncture tip 472 from the bone, thus reducing the force the user needs to apply to the lever 405. Rotating the lever 405 from the extended position to the initial or intermediate position translates the bone punch 470 from the second position back to the first position. Thereafter, if necessary, the bone punch 470 can be removed from the handle assembly 400, or the medical device can be removed from the treatment site.

[0160] Figure 23 yes Figure 22 A detailed view of a portion of a medical device, wherein a bone punch 470 is disposed in a second position and a rod 405 is disposed in an extended position. The connecting rod 420 may include an ejector block 421 slidably disposed within a housing 407. The ejector block 421 may include one or more pins 429 configured to engage the housing 407 and / or configured to slide longitudinally and / or axially within a channel formed in the housing 407. In some embodiments, the ejector block 421 may be configured to slide longitudinally and / or axially within a channel formed in the housing 407. In some embodiments, the ejector block 421 may be configured to slide parallel to the longitudinal axis of a sheath 403 and / or the bone punch 470 and / or the elongated shaft 474. In some embodiments, the sheath 403 may extend through and / or through the ejector block 421. Thus, the ejector block 421 may be slidably disposed around the sheath 403. Since the elongated shaft 474 may be slidably disposed within the sheath 403, the elongated shaft 474 may also extend through the ejector block 421. The head 476 of the bone punch 470 can be in the first position (e.g., Figure 21 ) and / or releasably coupled to the ejector block 421 when the rod 405 is in the initial or intermediate position. As the bone punch 470 translates distally from the first position to the second position (e.g., Figure 22 During this period, the head 476 of the bone punch 470 can push, squeeze, or otherwise translate the ejector block 421 distally within the housing 407 while remaining releasably engaged to the ejector block 421, thereby actuating the linkage 420 and causing the linkage 420 to rotate the distal end 409 of the rod 405 away from the housing 407 to an extended position.

[0161] In at least some embodiments, the ejector block 421 may include one or more magnets 419 disposed therein. In some embodiments, the one or more magnets 419, which are described in more detail herein, may be fixedly attached to the ejector block 421 using one or more of a variety of attachment methods, such as, but not limited to, adhesives, interference fits, friction fits, welding, co-molding, injection molding, etc. In some embodiments, the one or more magnets 419 may be embedded within the ejector block 421. In some embodiments, at least a portion of the one or more magnets 419 may be exposed to the outside of the ejector block 421, for example, exposed on the proximal-facing surface of the ejector block 421, facing or juxtaposed with the distal-facing surface of the head 476. In some embodiments, the one or more magnets 419 may be completely embedded within the ejector block 421 such that none of the one or more magnets 419 are exposed to the outside of the ejector block 421.

[0162] In some embodiments, the head 476 of the bone punch 470 may be magnetically coupled to the ejector block 421. As discussed herein, in some embodiments, the head 476 of the bone punch 470 may include one or more magnets 473 disposed therein, and the ejector block 421 may include one or more magnets 419 disposed therein. The one or more magnets 473 of the head 476 of the bone punch 470 may have opposite polarities to the one or more magnets 419 of the ejector block 421, so as to exert magnetic attraction on each other to releasably couple the head 476 of the bone punch 470 to the ejector block 421.

[0163] In some embodiments, one or more magnets 419 in the ejector block 421 may alternatively be magnetic materials (e.g., ferrous metals, etc.). Thus, the head 476 of the bone punch 470 may include one or more magnets 473 disposed therein, and the ejector block 421 may include magnetic materials disposed therein opposite to the one or more magnets 473 of the head 476, so as to apply magnetic attraction to each other to releasably connect the head 476 of the bone punch 470 to the ejector block 421.

[0164] In some embodiments, one or more magnets 473 in the head 476 of the bone punch 470 may alternatively be magnetic materials (e.g., ferrous metals or other materials attracted by the magnets). Thus, the ejector block 421 may include one or more magnets 419 disposed therein, and the head 476 of the bone punch 470 may include magnetic materials disposed therein opposite to the one or more magnets 419 of the ejector block 421, so as to apply magnetic attraction to each other to releasably connect the head 476 of the bone punch 470 to the ejector block 421.

[0165] In at least some embodiments, the link 420 may further include a distal connection 422 pivotally engaged with the housing 407 at a distal pivot point 423, and an intermediate connection 424 pivotally engaged with the ejector block 421 at a proximal pivot point 425. In some embodiments, the intermediate connection 424 may include a first intermediate connection 424A and a second intermediate connection 424B (not shown). In some embodiments, a proximal portion of the distal connection 422 may be disposed between the first intermediate connection 424A and the second intermediate connection 424B. In some embodiments, the distal portion of the distal connection 422 may include a pair of opposing legs extending on opposite sides of the sheath 403. One of the opposing legs may be configured to engage the first housing portion 407A, and one of the opposing legs (e.g., opposing legs) may be configured to engage the second housing portion 407B.

[0166] The distal connection 422 can pivotally engage with the intermediate connection 424 at an intermediate pivot point 426 between the distal pivot point 423 and the proximal pivot point 425. The distal pivot point 423 can be fixed axially and / or longitudinally relative to the housing 407. Thus, when the head 476 of the bone punch 470 translates distally to slide the ejector block 421 distally within the housing 407, the proximal end of the distal connection 422 and the distal end of the intermediate connection 424 can be laterally translated relative to the longitudinal axis of the sheath 403, the bone punch 470, and / or the elongated axis 474, by pivoting relative to each other at the intermediate pivot point 426 during the distal and / or longitudinal translation of the proximal end of the intermediate connection 424 to the distal connection 422 and / or the distal pivot point 423 distally and / or longitudinally. In some embodiments, the proximal pivot point 425, intermediate pivot point 426, and / or distal pivot point 423 may include one or more pins, shafts, or other elements and / or be defined thereon. Some examples of suitable, but not limiting, materials for the ejector block 421, distal connection 422, intermediate connection 424, and / or its elements or components are described below.

[0167] The distal connection 422 may include a cam surface 427 configured to engage a corresponding surface of the rod 405, wherein the corresponding surface of the rod 405 faces the housing 407, the longitudinal axis of the distal connection 422 and / or the sheath 403, the bone punch 470, and / or the elongated shaft 474. In some embodiments, the cam surface 427 may be curved. In some embodiments, the cam surface 427 may be convex. In some embodiments, the corresponding surface of the rod 405 may be curved. In some embodiments, the corresponding surface of the rod 405 may be convex. In some embodiments, the corresponding surface of the rod 405 may be concave. In some embodiments, the corresponding surface of the rod 405 may be a complex and / or irregular surface with concave and convex portions. Other configurations are also contemplated.

[0168] As described above, the handle assembly 400 may include a spring 411 disposed within a housing 407. The spring 411 may include a first arm 411A extending proximally from the winding portion and configured to engage the housing 407. In at least some embodiments, the first arm 411A may be configured to engage a first housing portion 407A (not shown). The spring 411 may include a second arm 411B extending distally from the winding portion and configured to engage a rod 405. For example, the rod 405 may include a slot formed therein configured to receive the second arm 411B. As described above, the function of the spring 411 and the rod 405 may be similar to and / or the same as described above. Figure 8-10 The spring 211 and rod 205 are described.

[0169] In some embodiments, the rod 405 may rotate toward a disengaged position toward the longitudinal axis of the housing 407 and / or the sheath 403, the bone punch 470, and / or the elongated shaft 474, such as... Figure 24 As shown, this is to assist in ejecting the bone punch 470 from the handle assembly 400. However, it should be understood that moving and / or translating the lever 405 toward and / or to the disengaged position is not absolutely necessary for ejecting the bone punch 470 from the handle assembly 400. In at least some embodiments, after the puncture tip 472 has been withdrawn from the bone, a retraction force sufficient to overcome the magnetic force connecting the head 476 of the bone punch 470 to the ejector block 421 may be manually applied to the head 476 of the bone punch 470 to separate the head 476 of the bone punch 470 from the ejector block 421, thereby allowing the bone punch 470 to be removed from the handle assembly 400.

[0170] Figure 25 An example configuration of housing 407 is shown, wherein housing 407 may include and / or be formed as a multi-piece structure including a first housing portion 407A and a second housing portion 407B as described herein. For illustrative purposes, the second housing portion 407B is rotated about axis XX to allow observation of the internal components and / or features of housing 407 and the external features of rod 405. In the illustrated example, viewed from proximal to distal, rod 405 may include a protrusion 440 extending laterally from the left side of rod 405. In some embodiments, protrusion 440 may be and / or may include a spring-loaded ball plunger disposed within a cavity formed in rod 405, wherein the ball of the spring-loaded ball plunger is biased at an extended position where the ball protrudes laterally from the outer surface of rod 405.

[0171] The second housing portion 407B may include a receiving feature 442 configured to align with and / or receive the ball of the protrusion 440 when the lever 405 is positioned in an initial and / or intermediate position. In the illustrated example, the receiving feature 442 includes an annular shoulder 444 extending inwardly from the second housing portion 407B, wherein the annular shoulder 444 defines a central aperture 446 configured to receive the ball of the protrusion 440 when the lever 405 is positioned in the initial and / or intermediate position, thereby helping to hold the lever 405 in the initial and / or intermediate position by preventing the lever 405 from moving freely and / or accidentally away from the initial and / or intermediate position. In some embodiments, when the lever 405 is in the extended position, the ball of the protrusion 440 is positioned in a direction away from the longitudinal axis of the sheath 403, and the ball of the protrusion 440 extends relative to the longitudinal axis of the sheath 403 on the opposite side of the receiving feature 442, above the receiving feature 442, outside and / or beside the annular shoulder 444 of the receiving feature 442 (viewed from the side), thereby helping to hold the lever 405 in the extended position by preventing the lever 405 from moving freely and / or accidentally away from the extended position. In some embodiments, when the lever 405 is in the disengaged position, the ball of the protrusion 440 is positioned in a direction toward the longitudinal axis of the sheath 403, and the ball of the protrusion 440 extends above the receiving feature 442, outside and / or beside the annular shoulder 444 of the receiving feature 442 (viewed from the side), on the same side of the receiving feature 442 as the longitudinal axis of the sheath 403, thereby helping to hold the lever 405 in the disengaged position by preventing the lever 405 from moving freely and / or accidentally away from the disengaged position. It should be understood that applying sufficient force to the lever 405 can overcome any resistance to movement provided by the ball of the protrusion 440 engaging with the receiving feature 442, so that the lever 405 can be selectively and intentionally moved between the aforementioned positions (e.g., initial and / or intermediate positions, extended positions, and disengaged positions).

[0172] Figure 26 An example configuration of housing 407 is shown, wherein housing 407 may include and / or be formed as a multi-piece structure, including a first housing portion 407A and a second housing portion 407B as described herein. For illustrative purposes, the second housing portion 407B is rotated about axis XX to allow observation of the internal components and / or features of housing 407 and the external features of rod 405. In the illustrated example, viewed from proximal to distal, rod 405 may include a protrusion 450 extending laterally from rod 405 on the right side of rod 405. In some embodiments, protrusion 450 may be and / or may include a fixed protrusion projecting laterally from the outer surface of rod 405.

[0173] The first housing portion 407A may include a receiving feature 452 configured to align with and / or receive the protrusion 450 therein. In at least some embodiments, the receiving feature 452 may include a plurality of recesses, including a first recess 452a, a second recess 452b, and a third recess 452c. Fewer and / or additional recesses and / or other configurations are also contemplated. In the illustrated example, the receiving feature 452 includes a proximal shoulder 454A and a distal shoulder 454B extending inwardly from the first housing portion 407A, wherein the proximal shoulder 454A and the distal shoulder 454B together define the first recess 452a, the second recess 452b, and the third recess 452c, which are configured to receive the protrusion 450 in an initial and / or intermediate position, an extended position, and a disengaged position, respectively. The receiving feature 452 and / or the plurality of recesses may be configured to help hold the lever 405 in one or more of the aforementioned positions (e.g., initial and / or intermediate positions, extended positions, and disengaged positions) by substantially preventing free and / or accidental movement of the lever 405.

[0174] In some embodiments, when the rod 405 is positioned in the initial and / or intermediate position, a portion of the protrusion 450 is disposed within and engages with the first recess 452a, thereby helping to hold the rod 405 in the initial and / or intermediate position by preventing free and / or accidental movement of the rod 405 away from the initial and / or intermediate position. In some embodiments, when the rod 405 is positioned in the extended position, the position of the protrusion 450 is moved in a direction away from the longitudinal axis of the sheath 403, and the protrusion 450 is disposed within and engages with the second recess 452b, thereby helping to hold the rod 405 in the extended position by preventing free and / or accidental movement of the rod 405 away from the extended position. In some embodiments, when the rod 405 is positioned in the disengaged position, the position of the protrusion 450 is moved in a direction toward the longitudinal axis of the sheath 403, and the protrusion 450 is disposed within and / or engages with the third recess 452c, thereby helping to hold the rod 405 in the disengaged position by preventing free and / or accidental movement of the rod 405 away from the disengaged position. It should be understood that applying sufficient force to the rod 405 can overcome any resistance to movement provided by the protrusion 450 that engages with the receiving feature 452 and / or the first recess 452a, the second recess 452b and / or the third recess, so that the rod 405 can be selectively and intentionally moved between the aforementioned positions (e.g., initial and / or intermediate positions, extended positions and disengaged positions).

[0175] Figure 27An example configuration of housing 407 is shown, wherein housing 407 may include and / or be formed as a multi-piece structure, including a first housing portion 407A and a second housing portion 407B as described herein. For illustrative purposes, the first housing portion 407A is rotated about axis XX to allow observation of the internal components and / or features of housing 407 and the external features of rod 405. In the illustrated example, rod 405 may include a polymer washer 460 disposed on and / or around a protrusion 462 extending laterally from rod 405 on the right side when viewed from the proximal side. In some embodiments, when viewed from the proximal side, polymer washer 460 may be disposed on and / or around a protrusion extending laterally from rod 405 on the left side of rod 405. In some embodiments, polymer washer 460 may be disposed on and / or around protrusions extending laterally from rod 405 on both the left and right sides of rod 405. Protrusions 462 (or multiple protrusions) may correspond to and / or be aligned with and / or coaxial with the pivot of the rod 405 relative to the housing 407. In some embodiments, the polymer washer 460 may be formed of and / or may include such a material having a high coefficient of friction relative to the housing 407 and / or the rod 405. For example, the polymer washer 460 may be formed of a rubber material, a polyurethane material, a silicone material, or another material that, compared to the absence of a polymer washer 460 (e.g., its absence), will increase the friction between the rod 405 and the housing 407 when the rod 405 rotates about the pivot.

[0176] The first housing portion 407A and / or the second housing portion 407B may each include a receiving feature 464 configured to receive the protrusion 462. In the illustrated example, the receiving feature 464 includes an annular shoulder 466 extending inwardly from the second housing portion 407B, wherein the annular shoulder 466 defines a central bore 468 configured to receive the protrusion 462. A polymer washer 460 may be configured to mattically and / or frictionally engage both the rod 405 and the annular shoulder 466 when the protrusion 462 is disposed within the central bore 468. In some embodiments, the polymer washer 460 may be clamped, compressed, and / or sandwiched between the rod 405 and the housing 407 (e.g., the first housing portion 407A and / or the second housing portion 407B). Such a configuration will increase friction between the rod 405 and the housing 407. Therefore, when the lever 405 is positioned in the initial and / or intermediate position, the polymer washer 460 helps to hold the lever 405 in the initial and / or intermediate position by preventing the lever 405 from moving freely and / or accidentally away from the initial and / or intermediate position. In some embodiments, when the lever 405 is positioned in the extended position, the polymer washer 460 helps to hold the lever 405 in the extended position by preventing the lever 405 from moving freely and / or accidentally away from the extended position. In some embodiments, when the lever 405 is positioned in the disengaged position, the polymer washer 460 helps to hold the lever 405 in the disengaged position by preventing the lever 405 from moving freely and / or accidentally away from the disengaged position. Materials that can be used for various components and elements of the medical devices disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to instruments. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, medical devices, housing assemblies, bone punches, bone screws, and / or their elements or parts.

[0177] In some embodiments, the device and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0178] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSMEngineeringPlastics), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, e.g., HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® available from Bayer or Elf). Atochem's CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX® under the trade name), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), and polyether imide (PEI) Polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from Advan Source Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0179] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.); and nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKE). LVAC®400, NICORROS®400, etc.); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.); nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY®ALLOYB2®); other nickel-chromium alloys; other nickel-molybdenum alloys; other nickel-cobalt alloys; other nickel-iron alloys; other nickel-copper alloys; other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0180] In at least some embodiments, the device and / or its components may also be partially or entirely doped with, made of, or otherwise comprised of a radiopaque material. A radiopaque material is understood to be capable of producing a relatively bright image on a fluorescent screen or other imaging technique during a medical procedure. This relatively bright image helps the user of the device determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Furthermore, other radiopaque marking strips and / or coils may also be incorporated into the design of the device to achieve the same result.

[0181] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the devices and / or other elements disclosed herein. For example, the device and / or its components or portions may be made of materials that substantially do not distort images or produce significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can produce artifacts in MRI images. The device or portions thereof may also be made of materials that are image-compatible with MRI machines. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N, etc.), nickel-titanium, etc., and others.

[0182] In some embodiments, the devices and / or other elements disclosed herein may include and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents may include antithrombotic agents (e.g., heparin, heparin derivatives, urokinase, and trifluoroacetate (d-phenylalanine-proline-arginine-chloromethyl ketone); antiproliferative agents (e.g., enoxaparin, angiopeptidase, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (e.g., dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vincristine, epoch-forming agents, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine); and anticoagulants (e.g., D-Phe-Pr). o-Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and those composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactivity mechanisms.

[0183] It should be understood that this disclosure is illustrative in many respects. Changes in detail may be made, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of the invention. To the extent appropriate, this may include using any feature used in one example embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A medical device configured to form one or more holes in a patient's bone, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongated shaft, a head at a proximal end of the elongated shaft, and a piercing tip at a distal end of the elongated shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongated shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a link disposed within the housing, the link including an ejector block slidably disposed within the housing; wherein the head of the bone punch is magnetically coupled to the ejector block at the first position.

2. The medical device of claim 1, wherein a distal translation of the head of the bone punch from the first position toward a second position causes the link to rotate a distal end of the lever away from the housing to the extended position.

3. The medical device of claim 2, wherein the lever is rotated from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position, causing the bone punch to translate proximally to withdraw the piercing tip from the bone.

4. The medical device of claim 2, wherein a distal translation of the head of the bone punch from the first position to the second position causes the ejector block to translate distally within the housing.

5. The medical device of claim 2, wherein a rotational position of the lever relative to the housing is indicative of a distance of distal translation of the piercing tip.

6. The medical device of claim 2, wherein a distal translation of the head of the bone punch from the first position toward the second position shortens an axial distance between a proximal-most pivot point of the link and a distal-most pivot point of the link.

7. The medical device of claim 1, wherein the head of the bone punch includes one or more magnets disposed therein, and the ejector block includes magnetic material disposed therein opposite the one or more magnets.

8. The medical device of claim 1, wherein the ejector block includes one or more magnets disposed therein, and the head of the bone punch includes magnetic material disposed therein opposite the one or more magnets.

9. The medical device of claim 1, wherein the head of the bone punch includes one or more magnets disposed therein, and the ejector block includes one or more magnets disposed therein opposite the one or more magnets disposed in the head of the bone punch.

10. The medical device of claim 1, wherein the head of the bone punch includes one or more magnets fixedly attached thereto, and the ejector block includes magnetic material disposed opposite the one or more magnets.

11. The medical device of claim 10, wherein the one or more magnets are exposed to an exterior of the head of the bone punch. ​ 12. The medical device of claim 1, wherein the ejector block includes one or more magnets fixedly attached thereto, and the head of the bone punch includes magnetic material disposed opposite the one or more magnets.

13. The medical device of claim 12, wherein the one or more magnets are exposed to an exterior of the head of the bone punch.

14. The medical device of claim 1, wherein the head of the bone punch includes one or more magnets fixedly attached thereto, and the ejector block includes one or more magnets fixedly attached thereto opposite the one or more magnets disposed in the head of the bone punch.

15. The medical device of claim 14, wherein the one or more magnets of the head of the bone punch are exposed to an exterior of the head of the bone punch.

16. The medical device of claim 14, wherein the one or more magnets of the ejector block are exposed to an exterior of the ejector block.

17. The medical device of claim 1, wherein the head of the bone punch includes a plurality of magnets spaced equidistant from a central longitudinal axis of the bone punch.

18. The medical device of claim 17, wherein the plurality of magnets are arranged symmetrically about the central longitudinal axis of the bone punch.

19. The medical device of claim 18, wherein the plurality of magnets are arranged in diametrically opposed pairs.

20. The medical device of claim 1, wherein the head of the bone punch is releasably coupled to the ejector block in the first position.

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