Improvements in surgical instruments, systems, and methods, and improvements related thereto.

Abstract

A surgical instrument (100) and a system incorporating such an instrument, the instrument including a stem (112) having a proximal end (116) and a distal end (110), a handle portion (114) toward the proximal end of the stem, and a guide element (108) toward the distal end of the stem, the guide element having a body element (131) defining a guide channel (128), the guide channel having a longitudinal axis (XX) and open at both ends along the longitudinal axis, and one or more positioning elements (130a, 130b). The instrument and system are suitable for removing a polyethylene acetabular liner (25) from an implanted shell (27) retaining the liner for replacement with another liner while minimizing the risk of damage to the shell.

Description

Technical Field

[0001] The present disclosure relates to the removal of a liner from an acetabular shell implant of the type used, for example, in hip arthroplasty. The present disclosure includes surgical instruments for such liner removal, systems for such liner removal, and methods of using the surgical instruments and / or systems.

Background Art

[0002] In hip arthroplasty, an anatomical reconstruction of the joint is required. The natural acetabulum is removed and replaced with an implant formed from an acetabular shell that is placed in a recess of the bone and fixed in place. Subsequently, a liner of the appropriate size is inserted, fitted, and locked into the shell. In some cases, it is necessary to remove a polyethylene acetabular liner from an implanted shell, for example, to remove the liner and replace it with another liner.

[0003] Existing designs provide a jaw-based surgical instrument that is used to apply a force to grip the liner and pull the liner from the shell.

[0004] It is desirable for a surgical instrument, system, or method of use to remove the liner without damaging the shell that holds the liner or risking damage to the shell. It is desirable for a surgical instrument, system, or method of use to be easily positioned, used, and removed. It is desirable for a surgical instrument, system, or method of use to effectively and reliably remove the liner at a wound site where access is difficult or restricted.

Summary of the Invention

Means for Solving the Problems

[0005] According to a first aspect of the present invention, there is provided a surgical instrument, the instrument comprising: a stem having a proximal end and a distal end, The handle portion is located towards the proximal end of the stem, It includes a guide element provided toward the distal end of the stem, and the guide element is A main body element that defines a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and One or more positioning elements are provided.

[0006] The guide channel may be completely surrounded by the main body element. The guide channel may also be a through-hole within the main body element.

[0007] The guide channel may be partially surrounded by the main element. For example, the guide channel may be surrounded by the main element by more than 190° around the longitudinal axis, optionally more than 200°, and more optionally more than 220°.

[0008] The guide channel can receive a cutting tool, such as a drill bit, when in use. The longitudinal axis of the guide channel may correspond to the operating axis of the cutting tool in use, or optionally, the rotation axis of the cutting tool. The guide channel can constrain the radial movement of the cutting tool, for example, with respect to the longitudinal axis of the guide channel and / or the operating axis of the cutting tool, when in use. The guide channel can allow axial movement of the cutting tool relative to the guide channel, for example, in one or both directions along the longitudinal axis of the guide channel and / or in one or both directions along the operating axis of the cutting tool, when in use.

[0009] The guide channel may define the angle of the hole formed in the liner by the cutting tool. The angle may be configured such that the hole formed in the liner is spaced away from the retaining mechanism for the liner within the shell. The angle may be configured such that the hole is formed closer to the center of the liner and / or shell than to the retaining mechanism.

[0010] The guide channel may define the position of the holes formed in the liner by the cutting tool. The position may be configured such that the holes formed in the liner are spaced apart from the retaining mechanism for the liner within the shell. The position may be configured such that the holes are formed closer to the center of the liner and / or shell than to the retaining mechanism.

[0011] The main body element may completely surround the guide channel. The main body element may only partially surround the guide channel. The main body element may have through holes, particularly straight cylindrical through holes. The through holes may have longitudinal axes inclined with respect to the upper surface and / or the lower surface of the main body element. The through holes may have longitudinal axes perpendicular to the upper surface and / or the lower surface of the main body element. The main body element may be at least partially annular around the longitudinal axis.

[0012] The guide element may include a main element and one or more positioning elements. The guide element may further include a base element. The guide element may consist of a main element, a base element, and one or more positioning elements.

[0013] One or more positioning elements may extend from guide elements, particularly base elements provided by the guide elements.

[0014] The base element may be located midway between the main body and a portion of the stem. The base element may, for example, provide a mount for the main body to the stem. The base element may be attached to the stem, particularly to the transition section of the stem, and optionally to the distal end of the transition section. The base element may be curved around its longitudinal axis.

[0015] One or more positioning elements may be adapted, for example, to provide a visual guide for precisely positioning and / or aligning the guide channel relative to the liner during use. One or more positioning elements may be adapted, for example, to provide a tactile guide for precisely positioning and / or aligning the guide channel relative to the liner during use.

[0016] One or more positioning elements may be provided by one or more positioning support bodies.

[0017] In one embodiment, a single positioning element may be provided. The single positioning element may be a curved element. The single positioning element may include an edge. The single positioning element may be provided by one or more positioning support bodies, for example, a pair of positioning support bodies extending on both sides of the guide element. Two or more positioning support bodies may provide a continuous positioning element.

[0018] In alternative embodiments, two or more positioning elements may be provided. Two positioning elements may be provided. One or more pairs of positioning elements may be provided. One or more or all halves of a pair of positioning elements may be provided by a first positioning support, and the other half may be provided by a second positioning support. The second positioning support may be a mirror image of the first positioning support.

[0019] A first positioning support extending in a first direction may be provided. The first direction may be a direction away from one side of the longitudinal axis. The first direction may be a direction away from one side of the guide element and / or the main element and / or the base element. The first positioning support may extend in a first further direction. The first further direction may be parallel to the longitudinal axis and distal. The first further direction may be a direction away distally from the guide element and / or the main element and / or the base element.

[0020] The first positioning support may have a proximal end. The proximal end may reach a base element or be connected to a base element. The first positioning support may have a distal end. The distal end may be distal to the proximal end of the first positioning support and / or further distal to the stem and / or base element and / or body element. The distal end may be the most distal part of the surgical instrument and may potentially be equal to the distal end of the second positioning support.

[0021] The first positioning support may be curved. The first positioning support may be curved away from the stem, particularly the transition section of the stem.

[0022] A second positioning support extending in a second direction may be provided. The second direction may optionally be a direction away from the first positioning support on the other side, away from the longitudinal axis to the second side. The second direction may optionally be a direction away from the first positioning support on the other side, away from the guide element and / or the main element and / or the base element to the second side. The second positioning support may extend in a second further direction. The second further direction may be parallel to the longitudinal axis and distal. The second further direction may be a direction away distally from the guide element and / or the main element and / or the base element.

[0023] The second positioning support may have a proximal end. The proximal end may reach or connect to a base element. The second positioning support may have a distal end. The distal end may be distal to the proximal end of the second positioning support and / or further distal to the stem and / or base element and / or body element. The distal end may be the most distal part of the surgical instrument and may potentially be equal to the distal end of the first positioning support.

[0024] The second positioning position support may be curved. The second positioning position support may be curved away from the stem, particularly the transition section of the stem.

[0025] The axis of symmetry may be present between the first positioning position support and the second positioning position support that extend parallel to the longitudinal axis.

[0026] The distal end of the first positioning position support and the distal end of the second positioning position support may define a chord extending therebetween. The chord may be closer to the longitudinal axis of the guide channel than a chord drawn between the first other part of the first positioning position support and the first other part of the second positioning position support, optionally between any other part of the first positioning position support and any other part of the second positioning position support. The chord may be closer to the longitudinal axis of the guide channel than a chord drawn between the proximal end of the first positioning position support and the proximal end of the second positioning position support.

[0027] One or more positioning positions may be provided by one or more positioning elements. One or more or all of the positioning positions may be positions that contact the liner during use.

[0028] In one embodiment, one positioning position is provided by one or more positioning elements. One positioning position may be provided by a curved portion of one or more positioning elements. One positioning position may be provided by an edge of one or more positioning elements. Optionally, one positioning position is provided by two positioning elements.

[0029] In alternative embodiments, two or more distinct positioning positions may be provided by one or more positioning elements. The two or more positioning positions may be provided by different curved portions of the two or more positioning elements, or optionally by different portions of the same curve. The two or more positioning positions may be provided by different edges of the two or more positioning elements, or optionally by different portions of the same edge. Optionally, the positioning positions may be provided by two or more positioning elements.

[0030] One, both, or all positioning elements may comprise one or more liner engagement elements. One, both, or all positioning positions may comprise liner engagement elements. Liner engagement elements may be provided at or adjacent to the end(s) of the positioning element(s). Liner engagement elements may be provided at or adjacent to the end(s) of the positioning position(s).

[0031] One or more of the positioning elements may include one or more liner penetrations. One or more of the positioning positions may include one or more liner penetrations. One or more of the liner engagement elements may include one or more liner penetrations. Liner penetrations may be provided at or adjacent to the end(s) of the positioning element(s). Liner penetrations may be provided at or adjacent to the end(s) of the positioning position(s).

[0032] One or more of the liner engagement elements may include a curved element, e.g., a curved edge. One or more of the liner engagement elements may include an edge. One or more of the curved elements and / or edge(s) may be provided toward or to the distal end of their positioning element. One or more of the curved elements and / or edge(s) may project away from the guide element, particularly away from the base element. One or more of the curved elements and / or edge(s) may project in the overall direction of the longitudinal axis. One or more of the curved elements and / or edge(s) may extend toward the liner when in use. One or more of the curved elements and / or edge(s) may extend toward the peripheral wall of the liner at the junction between the liner and the shell when in use. One or more of the curved elements and / or edges may be in contact with or extend from a wider portion (e.g., a base element) to limit the depth of tooth penetration into the liner during use.

[0033] One or more of the liner engagement elements may be teeth. Optionally, two teeth may be provided on each positioning element. One or more of the teeth may be provided toward or toward the distal end of those positioning elements. One or more of the teeth may be provided by a margin, for example, the end of a curved margin. One or more of the teeth may project away from the guide element, particularly away from the base element. One or more of the teeth may project in the overall direction of the longitudinal axis. One or more of the teeth may extend toward the liner during use. One or more of the teeth may extend toward the peripheral wall of the liner at the junction between the liner and the shell during use. One or more of the teeth may abut against or extend from a wider portion (e.g., the base element) to limit the depth of tooth penetration into the liner during use.

[0034] One or more secondary positioning positions may be provided by one or more positioning elements. One or more secondary positioning positions may contact the liner during use. One or more secondary positioning positions may be provided by guide elements. One or more secondary positioning positions may be provided by body elements. One or more secondary positioning positions may be provided by the distal end face of the body element. The distal end face may be flat. One or more secondary positioning positions may contact the upper surface of the liner and / or the upper surface of the shell during use.

[0035] The guide element may be provided at the distal end of the stem.

[0036] The guide element may be connected to a first section of the stem. The guide element may be connected to a transition section of the stem. The transition section may extend away from the guide element in a direction having a radial component with respect to the longitudinal axis, optionally. The radial component may be the principal component of the directional range of the transition section. The transition section may provide a gap or space between the longitudinal axis and one or more or all of the stem and / or handle portions.

[0037] The stem may include a second section. The second section may be connected to the first section. The stem may include an alignment section. The alignment section may extend in a direction having a component parallel to the longitudinal axis. The parallel component may be the principal component of the directional range of the alignment section. The alignment section may substantially maintain a gap or spacing between the longitudinal axis and one or more or all of the stem and / or handle parts. The alignment section may not substantially increase or decrease the gap or spacing between the longitudinal axis and one or more or all of the stem and / or handle parts.

[0038] The stem may include a third section. The third section may be connected to the second section. The stem may include an inclined section. The inclined section may extend in a direction having a component parallel to the longitudinal axis and a component radial to the longitudinal axis. The parallel component may be the dominant component of the directional range of the inclined section. The inclined section may have an intersection angle with the longitudinal axis of 20° to 45°, for example, 25° to 35°. The inclined section may increase the gap or spacing between the longitudinal axis and one or more or all of the stem and / or handlebar portions. The inclined section does not have to substantially decrease the gap or spacing between the longitudinal axis and one or more or all of the stem and / or handlebar portions.

[0039] One or more sections of the stem may be configured to provide a line of sight toward the guide element, or optionally a line of sight to the guide element, for example, a line of sight to one or more positioning elements, between the stem and the longitudinal axis.

[0040] The handle portion may be provided at the proximal end of the stem. The handle portion may be configured to assist in gripping the handle. The handle may be oriented and / or configured and / or positioned to keep the user's hand out of line of sight toward the guide element.

[0041] The handle portion may be configured to allow the user to apply axial force, particularly to the guide element, along the longitudinal axis and / or parallel to the longitudinal axis. The handle portion may also be configured to allow the user to apply radial force, particularly to the guide element.

[0042] The first aspect of the present invention may include any other features, options, or possibilities described herein, including other aspects of the present invention, which may be adopted individually or in any combination.

[0043] According to a second aspect of the present invention, a surgical system is provided, the surgical system is Surgical instruments, A stem having a proximal end and a distal end, The handle portion is located towards the proximal end of the stem, A guide element provided toward the distal end of the stem, wherein the guide element is A main body element that defines a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and A surgical instrument comprising a guide element that provides one or more positioning elements, and The system in question is One or more cutting tools, Further comprising one or more elongated, at least partially threaded elements.

[0044] Surgical instruments may be provided according to a first aspect of the present invention and / or may include any other features, options, or possibilities described herein, including other aspects of the present invention, any of which may be employed individually or in any combination.

[0045] The surgical system may further include an actuator for applying torque to the cutting tool, particularly during use. The actuator may act directly on the cutting tool or be connected to one or more intermediate elements, such as a drive extension. The actuator may be manual or electrically operated.

[0046] One or more cutting tools may be drill bits or include drill bits. One or more cutting tools may be provided separately from surgical instruments. One or more cutting tools may have a distal section provided with one or more cutting blades. One or more cutting tools may have a proximal end having an engagement portion for an actuator or intermediate element. The engagement portion may provide torque transmission to the cutting tool. The engagement portion may provide distal axial force transmission to the cutting tool.

[0047] The guide channel of the surgical instrument may be configured to receive a cutting tool, such as a drill bit, and the cross-section of the guide channel is the cross-section of the cutting tool with added clearance. The longitudinal axis of the guide channel may correspond to the axis of motion of the cutting tool in use, or optionally, the axis of rotation of the cutting tool.

[0048] The cutting tool may be introduced into the guide channel on the upper side of the main element. The cutting tool may extend through the guide channel and beyond the lower side of the main element. The cutting tool may provide a cutting motion extending from the lower side of the main element. After use, the cutting tool may be retracted in and out of the guide channel.

[0049] The guide channel may define the angle of the hole formed in the liner by the cutting tool.

[0050] One or more or all of the elongated, at least partially threaded elements may be provided with threads, particularly self-tapping threads. One or more elongated elements may be provided separately from the surgical instruments. One or more elongated elements may have a distal section provided with one or more threads. One or more elongated elements may have a proximal end having an engagement portion for an actuator or intermediate element. The engagement portion may provide transmission of torque to the elongated element. The engagement portion may provide transmission of distal axial force to the elongated element.

[0051] The engaging portion of the cutting tool and / or the engaging portion of the elongated element may have any of the following further options, features, and possibilities, as described in the following distinct embodiments of the present disclosure.

[0052] A second aspect of the present invention may include any other features, features, options, or possibilities described herein, including other aspects of the present invention, any of which may be adopted individually or in any combination.

[0053] According to a third aspect of the present invention, an engagement system for surgical components and an actuator system for surgical tools are provided, wherein the engagement portion is The internal bore in the distal end of the actuator system element, A male section on the proximal end of a surgical tool, adapted to be received within an internal bore, The male section includes one or more engaging surfaces that cooperate with one or more engaging surfaces contained within the internal bore to provide torque transmission from the actuator system to the surgical tool, The male section located within the internal bore compresses an elastic element between a portion of the male section and a portion of the internal bore, providing a certain level of resistance to the axial movement of the male section exiting the internal bore.

[0054] Surgical components may be surgical tools. Surgical tools may be cutting tools or, for example, drill bits. Surgical components may be surgical tools such as elongated elements that are at least partially threaded for separating the liner and the shell.

[0055] The actuator system may include manual or electric actuators. The actuator system may include one or more intermediate elements (e.g., drive extensions) provided between the actuator and the surgical tool. Optionally, the surgical tool is attached to the drive extension.

[0056] The internal bore may be located at the distal end of the actuator, or at the distal end of an intermediate element such as a drive extension.

[0057] The male section may be provided with one or more external engagement surfaces. The internal bore may optionally be provided with one or more internal engagement surfaces having a profile that engages with at least a portion of one or more external engagement surfaces of the male component. The external engagement surfaces of the male section may correspond to the internal bore engagement surfaces minus tolerances. A hexagonal cross-sectional profile may be applied to the external and / or internal engagement surfaces.

[0058] The internal bore may have a depth defined by the base section. Optionally, the proximal end of the surgical tool may abut against the base section during use. Optionally, the abutment constrains the axial movement of the surgical tool into the bore and / or allows for the application of axial force to push the surgical tool into the liner material.

[0059] The elastic element may be an O-ring. The O-ring may be held in a groove provided in the surgical tool. The O-ring may have a radial range that exceeds the limits of the groove in order to provide compressibility. The O-ring may be opposed by an annular surface in the internal bore. The O-ring may have a first incompressible state in which its maximum radius or maximum profile exceeds the minimum radius or minimum profile of the opposing surface in the internal bore. The O-ring may have a second compressible state in which its maximum radius or maximum profile is reduced by the opposing surface in the internal bore.

[0060] The elastic element may be held on the male section. The elastic element may be held closer to the proximal end than the engagement surface. The elastic element may be held further from the proximal end than the engagement surface.

[0061] An elastic element may be provided between a portion of the male section and a portion of the internal bore.

[0062] The level of resistance to axial movement of the male section out of the internal bore may exceed the level required to hold the proximal end of the surgical tool within the internal bore during movement to and / or away from the use position, and / or insertion into the liner via the guide channel. The level of resistance to axial movement of the male section out of the internal bore may exceed the level required to prevent the weight of the surgical tool or impact to the surgical tool from causing the surgical tool to dislodge from the internal bore.

[0063] The level of resistance to axial movement may be less than the level at which the operator would encounter difficulty removing a surgical tool from the internal bore.

[0064] A third aspect of the present invention may include any other features, features, options, or possibilities described herein, including other aspects of the present invention, any of which may be adopted individually or in any combination.

[0065] According to a fourth aspect of the present invention, a method is provided for removing a liner from the acetabular shell, the method being: To provide surgical instruments, the instruments are A stem having a proximal end and a distal end, The handle portion is located towards the proximal end of the stem, A guide element provided toward the distal end of the stem, wherein the guide element is A main body element that defines a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and To provide a surgical instrument comprising a guide element that provides one or more positioning elements, Positioning one or more positioning elements on the surface of the liner and / or shell, This involves introducing the cutting tool into the liner, and the cutting tool passing through the guide channel. This includes cutting holes in the liner using a cutting tool.

[0066] The method may further include introducing an elongated, partially threaded element into a hole in the liner, and optionally tapping the threaded element into the liner to push the liner away from the shell.

[0067] The method may include introducing the instrument into the liner and / or shell, and then adjusting its position to position one or more positioning elements. The method may include introducing one or more of the positioning elements onto the upper surface of the liner and / or the upper surface of the shell. The method may include introducing the instrument in close proximity to the joint between the shell and the liner. The method may include adjusting the position of one or more positioning elements so that they are in contact with a portion of the joint, for example, the upper surface of the shell and the side wall of the liner extending above the upper surface of the shell. The distal ends of one or more positioning elements may be introduced and / or positioned in this manner.

[0068] This method may include introducing the distal end(s) of one or more positioning elements to the upper surface of the shell to restrict the substantially axial movement of the instrument. This method may also include adjusting the position by sliding the distal end(s) radially inward toward the liner relative to the shell. This method may also include positioning the positioning element(s) by bringing them into contact with the peripheral wall of the liner. Positioning may resist further inward movement of the distal end(s) of the positioning element(s).

[0069] This method may include defining the axis of a hole in the liner using the longitudinal axis of the guide channel.

[0070] This method may include positioning by bringing one or more positioning elements into contact with the outside of the liner, and then performing final positioning by penetrating one or more parts of a guide element into the liner material. One or more positioning elements may penetrate the liner. One or more positioning positions may penetrate the liner. One or more liner engagement elements may penetrate the liner. One or more teeth may penetrate the liner.

[0071] By applying radial force to the guide element via the handle portion, penetration of the liner into the material, particularly into the peripheral wall, can be induced. By preventing the limited range of the tooth and / or the portion of the guide element adjacent to the tooth from penetrating the liner, the radial position of the positioning element, optionally the guide element, and ideally the guide channel, can be finally determined.

[0072] This method may include introducing a cutting tool to an intermediate element such as an actuator or a drive extension.

[0073] This method may include introducing the cutting tool into the liner by one or more of the following: introducing the cutting tool into the guide channel on the upper side of the main element, and / or extending the cutting tool through the guide channel beyond the lower side of the main element, and / or advancing the cutting tool axially so as to contact the liner.

[0074] This method may include cutting a hole using a cutting tool that extends from the underside of the main element.

[0075] This method may include, for example, rotating the cutting tool manually or using an electric actuator.

[0076] The method may include the guide channel constraining the radial movement of the cutting tool, for example, with respect to the longitudinal axis of the guide channel and / or the operating axis of the cutting tool. The method may also include the guide channel allowing axial movement of the cutting tool relative to the guide channel, for example, in one or both directions along the longitudinal axis of the guide channel and / or in one or both directions along the operating axis of the cutting tool.

[0077] The method may include, for example, retracting the cutting tool once a hole of the desired depth has been formed. The method may also include, for example, disengaging the surgical instrument from the liner and / or removing the surgical instrument from proximity to the liner and / or removing one or more parts of the surgical instrument from within the liner material once a hole of the desired depth has been formed and / or once the cutting tool has been retracted from the guide channel.

[0078] This method may involve repeating one, more, or all of the steps of providing, introducing, positioning, cutting, and removing at multiple locations in order to provide other holes. The other holes may be spaced apart around the entire circumference of the liner.

[0079] This method may include the use of the same fixture and / or guide channel and / or cutting tool size and / or elongated threaded element size for a range of liner sizes and / or thicknesses.

[0080] This method may include introducing an elongated, partially threaded element into an actuator or an intermediate element such as a drive extension. The actuator and / or intermediate element may be the same as the one previously attached to the cutting tool.

[0081] The method may further include introducing the distal end of an elongated, partially threaded element into a hole in the liner. The threaded element may be self-tapping. The method may include rotating the threaded element to advance it into the liner. The method may also include advancing the threaded element through the liner to contact the shell. The method may include further rotating the threaded element to displace the liner away from the shell toward the surgical instrument, but optionally, the threaded element may not be advanced further.

[0082] A fourth aspect of the present invention may include any other features, features, options, or possibilities described herein, including other aspects of the present invention, any of which may be adopted individually or in any combination. [Brief explanation of the drawing]

[0083] Various embodiments of this disclosure will be described below, for illustrative purposes only, with reference to the attached drawings. [Figure 1a] This is a side view of a conventional liner extraction device. [Figure 1b] This is a perspective view of the device shown in Figure 1a, which is engaged with the liner. [Figure 1c] This is a side view corresponding to Figure 1b. [Figure 1d] This is a side view showing the liner partially removed from the shell. [Figure 2] This is a perspective view of the system according to this disclosure, including the guide device, drill bit, screw, and drive extension. [Figure 3] This is a top view of the guide instrument's distal end and the cut drill bit engaged with the liner inside the shell. [Figure 4] This is a side view corresponding to Figure 3. [Figure 5] This is a detailed perspective view of the distal end of the drive extension, the proximal end of the drill bit, and the proximal end of the screw according to another embodiment of the present disclosure. [Figure 6] This is a side view showing the interaction between the liner and the shell in the first combination. [Figure 7] This is a side view showing the interaction between the liner and the shell in a second combination. [Figure 8] This is a detailed side perspective view of the guide component where the drill bit is located. [Figure 9] This shows the pilot holes for the liner and shell. [Modes for carrying out the invention]

[0084] In hip arthroplasty, anatomical reconstruction of the joint is required. The natural acetabulum is removed and replaced with an implant formed from an acetabular shell, which is positioned and fixed in place within the bony recess. Subsequently, a liner of the appropriate size is inserted into the shell, fitted, and locked. In some cases, it may be necessary to remove a polyethylene acetabular liner from the implanted shell, for example, by removing that liner and replacing it with another. This must be done while minimizing the risk of damaging the shell that holds the liner.

[0085] A liner extraction tool 1, a prior art instrument, is illustrated in Figure 1a. This tool provides a first jaw 3 and a second jaw 5 that are pivotally mounted relative to each other around a pin 7. The distal end 9 of the first jaw 3 extends beyond the distal end 11 of the second jaw 5. The distal end 9 of the first jaw 3 is provided with a pair of contact surfaces 13 that face the second jaw 5. The distal end 11 of the second jaw 5 is provided with a pair of teeth 15 that generally face toward the first jaw 3.

[0086] As shown in Figure 1b, the first jaw 3 has a separate central element 17 provided between the first jaw element 19a and the second jaw element 19b, and these are combined to form the first jaw 3. The distal end 21 of the central element 17 has a contact surface 23 that is approximately perpendicular to the pair of contact surfaces 13.

[0087] When the first jaw 3 and the second jaw 5 are open wider than shown in Figure 1a, which shows them in a closed state, the liner extraction tool 1 can engage with the liner 25 located within the shell 27, as shown in Figure 1c. The contact surface 23 contacts the circumferential surface 29 of the shell 27. This restricts the axial movement of the liner extraction tool 1 relative to the shell 27. The pair of contact surfaces 13 abut against the small side wall 31 of the liner 25. When the jaws are closed by moving the second jaw 5 inward toward the first jaw 3, the pair of teeth 15 contact the inside of the liner 25. The teeth 15 are sharp enough to penetrate the liner 25 when force is applied through the liner extraction tool 1, as the contact surfaces 13 and the side wall 31 combine to prevent movement of the first jaw 3.

[0088] Figure 1d shows the liner 25 partially detached from the shell 27. This is achieved by the retraction of the first jaw element 19a and the second jaw element 19b relative to the central element 17. Thus, the central element 17 maintains the position of the shell 27, while the liner 25 is loosened from the shell 27.

[0089] Since access to the wound site is not easy, positioning the liner removal tool 1 by keeping the contact surface 23 and contact surface 13 in the required position while the contact surface and contact surface are moving relative to each other can be difficult.

[0090] Another tool-based option for removing the liner 25 is to create pilot holes in the liner 25. A self-tapping screw is then first engaged in the pilot hole and tightened with enough force to push the liner 25 between the liner 25 and the shell 27, thereby removing the liner 25 from the shell 27. If the liner 25 is of a thicker and / or larger and / or more rigid type, multiple pilot holes and self-tapping screws may be required.

[0091] For this type of option to be effective, the pilot hole must be formed at a consistent and precise location and at a consistent angle relative to the liner 25. This must be achieved in wound spaces that often offer only limited access.

[0092] Figure 2 illustrates one embodiment of the present disclosure, which provides a surgical instrument in the form of a guide device 100, a surgical tool in the form of a drill bit 102, and an intermediate section in the form of an extension drive unit 104. Figure 2 also shows the same extension drive unit 104 engaged with a self-tapping screw 106, which is a different surgical tool.

[0093] The guide instrument 100 includes a guide element in the form of a guide component 108 at its distal end 110. The guide component 108 is mounted on the stem 112, and the handle portion 114 is at the proximal end 116. The stem 112 is divided into several sections. The first section, the transition section 118, separates the rest of the guide instrument 100 from the operating axis of the drill bit 102. The second section, the alignment section 120, is aligned with the operating axis of the drill bit 102 but spaced away from it, thereby aligning the force applied to the liner 25 via the handle portion 114 during use with the axis along which the force applied via the drill bit 102 during use is transmitted to the liner 25. The third section, the inclined section 124, is inclined away from the operating axis of the drill bit 102 to increase space and improve the surgeon's line of sight to the distal end 110. The third section, the inclined section 124, connects to the handle portion 114.

[0094] During use, as shown in Figure 3, the distal end 110 of the guide device 100 is close to the joint 126 between the liner 25 and the shell 27. The guide component 108 of the distal end 110 provides a guide channel in the form of a through hole 128 through which the drill bit 102 can be inserted. The axis of the bore 128 coincides with the operating axis of the drill bit 102 during use.

[0095] The guide component 108 is configured to provide visual cues and guides for precise alignment / positioning with respect to the liner 25 and / or shell 27. The guide component 108 includes a first extending element 130a extending from the main element 131, provided at the junction of the guide component 108 and the transition section 118. The first extending element 130a extends in a first direction. A second extending element 130b is provided similarly but extends in the opposite direction. The first and second extending elements constitute a form of positioning support. Both the first extending element 130a and the second extending element 130b have a main element contact end 132 and an extending element protruding end 137. The two protruding ends 137 are oriented toward each other. The chord drawn between the two protruding ends 137 will pass closer to the axis of the bore 128 than the chord drawn between the other parts of the extending element, particularly between the main element contact end 132. In the exemplary embodiment, this is provided by the curvature of the first extending element 130a and the second extending element 130b.

[0096] As seen in Figures 6, 7, and 8, a flat distal end face 136 is provided around the bore 128 at the distal end 110 of the guide component 108. This is one form of a secondary positioning position. In this embodiment, a common distal end is provided for both the first extending element 130a and the second extending element 130b by a continuous flat distal end face 135. This distal end face 135 extends over the entire length of the curvature of both the first extending element 30a and the second extending element 30b. This is one form of a positioning position. The distal end face 135 is provided in the distal end section 139. The distal end section 139 has a smaller cross-section further away from the distal end face 135 than the position of the distal end face 135, and thus the distal edge 134 is defined. In this embodiment, the distal margin 134 extends along the entire curvature of both the first extending element 30a and the second extending element 30b.

[0097] Referring to Figure 6, the interaction between the distal edge 134 and the first combination of the shell 27 and liner 25 is shown. In this embodiment, the degree to which the liner 25 protrudes from the shell 27 is relatively small, and therefore the peripheral wall 140 has only a small height. Different interactions occur for different combinations of the liner 25 and shell 27, as will be further illustrated below.

[0098] In Figure 6, the distal end face 135 and distal edge 134 have a greater distal range relative to the guide device 100 than the guide component 108, for example, its distal end face 136. The flat distal end face 135 is parallel to the distal end face 136 of the guide component 108, but they are not coplanar.

[0099] During use, this means that as the guide instrument 100 is moved toward the shell 27 and liner 25, one end of the distal end face 135, then the other end, or both simultaneously, abuts against the circumferential end face 138 of the shell 27. This restricts the generally axial movement of the guide instrument 100. Next, the distal end face 135 can be slid radially inward relative to the shell 27 and liner 25 across the end face 138. This continues until a portion of the distal margin 134 abuts against the raised peripheral wall 140 of the liner 25, which is formed by the liner 25 extending slightly above the plane of the end face 138 of the shell 27. At this point, the liner 25 resists further inward movement. In the illustrated embodiment, the curvature of the distal margin 134 is such that the end of the distal margin 134 provides a contact surface. The contour of the distal margin 134 is such that its end acts like a tooth 142. The distal edge 134 faces laterally away from the extending elements with respect to the proximal-distal orientation of the extending elements. That is, the distal edge 134 faces toward the liner 25 during use, and particularly toward the peripheral wall 140 at the joint between the liner 25 and the shell 27. By applying a radial force to the guide part 108 via the handle portion 114, the teeth 142 at the end of the distal edge 134 penetrate the material of the liner 25, and particularly the peripheral wall 140. The limited extent of the distal edge 134, and the impossibility of penetrating the extending elements behind them into the liner 25, means that the radial position of the extending elements 130a, 130b, and therefore the guide part 108, and therefore the bore 128, is very precisely controlled. The pilot hole is formed in a consistent and precise position.

[0100] In the alternative configuration, the curvature of the distal margin 134, particularly its radius of curvature, may be greater than the curvature of the liner, particularly its radius of curvature, such that an intermediate position on the distal margin 134 contacts the liner. The distal margin 134 is sharp along its length sufficiently to penetrate the liner 25 and thus acts like a tooth when it contacts it.

[0101] Figure 9 shows the pilot hole 202 formed by the drill bit 102. The drill bit 102 extends into the liner 25 through the guide part 108 and downward to the joint between the liner 25 and the shell 27. The teeth 142 at the end of the curved edge 134 engage with the liner 25.

[0102] The location used for the pilot hole 202 is adjacent to the periphery of the liner 25 and also adjacent to the periphery of the shell 27. In this region, contact between the shell 27 and the liner 25 is not intended during use, and therefore, even if the removal of the liner 25 according to this disclosure causes minor damage to the shell 27, that minor damage is not located in the material area on the shell 27. If a further inward location within the liner 25 is used, for example, at or near the poles of the liner 25 and shell 27, some damage to the material area will occur. However, the location used for the pilot hole 202 is sufficiently radially inward from the edge of the liner 25 so that the pilot hole 202 is away from the retaining mechanisms 204, 206 for the liner 25 within the shell 27. In the exemplary embodiment, a lug 204 on the shell 27 engages with a recess 206 on the liner 25, but other retaining mechanisms are also possible.

[0103] The peripheral position of the pilot hole 202 has been established in tests to provide the most effective method for removing the liner 25 from the shell. This is particularly important for providing sufficient force to overcome the retaining force between the liner 25 and the shell 27. The peripheral position is more effective than a position further inside the liner 25, for example, at or near the pole 208 of the liner 25 and shell 27.

[0104] Referring to Figure 7, different interactions between the distal edge 134 and the first combination of the shell 27 and liner 25 are shown. In this embodiment, the liner 25 protrudes relatively far from the shell 27, and therefore the peripheral wall 140 has considerable height.

[0105] During use, this means that as the guide instrument 100 is moved toward the shell 27 and liner 25, the distal end face 136 contacts the circumferential end face 200 of the liner 25. This restricts the generally axial movement of the guide instrument 100. At this position, the distal edge 134 is still spaced apart from the circumferential end face 138 of the shell 27, but the distal edge 134 can still be slid radially inward relative to the shell 27 and liner 25 until the section of the distal edge 134, the end teeth 142 in the illustrated embodiment, contacts the raised peripheral wall 140 of the liner 25 formed by the liner 25 extending slightly above the plane of the end face 138 of the shell 27. At this point, the liner 25 resists further inward movement. By applying a radial force to the guide component 108 via the handle portion 114, the distal edge penetrates the material of the liner 25, and in particular the peripheral wall 140.

[0106] The above embodiment refers to teeth 142 at each end of a continuous distal margin 134 for providing penetration into the liner 25, but it is possible to provide two or more teeth at other locations. A series of teeth spaced apart along the distal margin 134 and / or serrated distal margin 134 may be provided. Similarly, it is also possible to rely on an intermediate portion of the distal margin 134 for engaging with and penetrating the liner 25.

[0107] The configuration of the distal edge 134 and / or teeth 142 of the extended element means that a wide range of different diameters of shells 27 and liners 25 can be successfully used with the same guide instrument 100.

[0108] The drill bit 102 is provided separately from the guide fixture 100 and can optionally be attached to the extension drive unit or other actuator 104 in a manner described in more detail below. Drill bits 102 of the same diameter are suitable for a wide range of liner sizes 25, and therefore, given guide parts 108 and guide fixtures 100 are also widely applicable.

[0109] The through-hole 128 of the guide part 108 has an axis XX that gives a desired pilot hole at a consistent angle with respect to the liner 25, because the bore 28 restricts the operating axis of the drill bit 102 to the same axis XX. The cross section of the bore 28 perpendicular to axis XX (+ clearance tolerance) matches the cross section of the drill bit 102 which is similarly perpendicular to axis XX.

[0110] Therefore, during use, with the guide instrument 100 in place on the shell 27 and liner 25, and with the distal edge 134 or a portion of the teeth 142 embedded in the material of the liner 25, the drill bit 102 of the drive extension 104 slides within the bore 128 and contacts the surface of the liner 25. A manual or electric actuator 300 (Schematically shown in Figure 2) connected to the drive extension 104 is used to rotate the drill bit 102 and thus form a pilot hole in the liner 25. Once a pilot hole of the desired depth is formed, the drive extension 104 and the drill bit 102 can be retracted. The guide instrument 100 can then be moved outward to disengage the distal edge 134 or portion of the teeth 142, and then the guide instrument 100 can be withdrawn.

[0111] If necessary, this process can be repeated at other locations to create additional pilot holes.

[0112] A self-tapping screw 106 is provided on the drive extension 104, which may be the same as the removed drill bit 102. The distal end of the screw 106 is inserted into the end of the pilot hole, and the screw 106 is advanced into the liner 25 by rotating the drive extension 104. As the screw 106 continues to advance, the liner 25 is displaced from the shell 27.

[0113] The drill bit 102 can be attached to the extension drive unit 104 or other actuator 104 in various ways. One option according to this disclosure is shown in Figure 5.

[0114] The drive extension 104 has an internal bore at its distal end 300, which receives the proximal end 302 and end section 304 of the drill bit 102, and similarly the proximal end 306 and end section 308 of the screw 106. The end sections 304, 308 have equivalent cross-sectional profiles and, as shown, are provided with six regularly spaced, sized flat sections 310, which provide a hexagonal drive interface. The internal bore of the drive extension 104 has a corresponding drive profile and, in the illustrated case, has six regularly spaced, sized flat sections 310 that provide a hexagonal drive interface. The cooperation of the two drive surfaces easily transmits torque from the drive extension 104 to the drill bit 102 or screw 106. The depth of the internal bore, when considered along axis XX, corresponds to the length of the end sections 304, 308, and as a result, the contact between the proximal ends 302, 306 and the base 312 of the bore 314 results in precise alignment of the drive interface. The contact also restrains the axial movement of the drill bit 102 or screw 106 into the drive extension 104 and allows for the application of an axial force that propels the drill bit 102 or screw 106 into the material of the liner 25.

[0115] It is desirable to provide easy engagement and disengagement between the drill bit 102 and / or screw 106 and the drive extension 104. At the same time, it is necessary to hold the drill bit 102 and / or screw 106 on the drive extension 104 during movement to and from the use position. In this disclosure, this level of axial constraint of the drill bit 102 and / or screw 106 against relative axial movement away from the drive extension 104 is provided by the interaction of one O-ring 312 and the other surface. In one embodiment, the O-ring 312 is provided on the disposable drill bit 102 rather than in the internal bore 314 of the drive extension 104. Similarly, the O-ring 312 may be provided on the disposable screw 106 rather than in the internal bore 314 of the drive extension 104.

[0116] In one embodiment, when the drill bit 102 slides within the internal bore 314, the internal contour of the bore 314 causes compression of the O-ring 312, at least when the proximal end 302 approaches the base 312 of the bore 314. The elasticity of the O-ring 312 resists this compression and, therefore, resists axial movement of the drill bit 102 from the bore 314. This resistance is sufficient to prevent the weight of the drill bit 102 or impacts to the drill bit 102 from separating the drill bit 102 from the drive extension 104. The O-ring 312 on the screw 106 operates and interacts in a similar manner. However, since the resistance to axial movement is limited, the drill bit 102 or screw 106 can be easily removed from the drive extension 104 as needed, for example, to replace the drill bit 102 with the screw 106. Since the drill bit 102 and screw 106 are intended to be disposable, there is no need to sterilize the structure on which the O-ring 312 resides.

[0117] While various modifications and alternative forms are possible for the concepts of this disclosure, specific embodiments are shown in the drawings as examples and described in detail herein. However, it should be understood that it is not the intention of this disclosure to limit the concepts to the specific forms disclosed, but rather to encompass all modifications, equivalents, and alternatives included in this disclosure and the attached "Claims."

[0118] [Implementation Method] (1) Surgical instruments, A stem having a proximal end and a distal end, A handle portion provided toward the proximal end of the stem, The stem includes a guide element provided toward the distal end, and the guide element is A main body element defining a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and A surgical instrument providing one or more positioning elements. (2) The apparatus according to Embodiment 1, wherein the guide channel is adapted to receive a cutting tool, and the longitudinal axis of the guide channel corresponds to the axis of motion of the cutting tool in use. (3) The apparatus according to Embodiment 2, wherein the guide channel is adapted to restrict the radial movement of the cutting tool and to allow the axial movement of the cutting tool relative to the guide channel. (4) The apparatus according to Embodiment 3, wherein one or more or all of the positioning elements include one or more liner penetration portions. (5) The apparatus according to Embodiment 3, wherein two or more positioning elements are provided, and each positioning element includes a liner penetration portion toward its distal end.

[0119] (6) The apparatus according to embodiment 5, wherein at least two portions of the curved edge provide the liner penetration portion when in use. (7) The apparatus according to Embodiment 1, wherein a pair of positioning support members extend from both sides of the main body element, and the pair of positioning support members provide two or more liner penetration portions. (8) The device according to Embodiment 1, wherein the curved element and / or edge is provided toward the distal end of the positioning element, and the curved element and / or edge protrudes toward the longitudinal axis of the guide channel toward the guide element. (9) The apparatus according to Embodiment 1, wherein the distal end of a positioning support provided by a positioning element and the distal end of a further positioning support provided by a positioning element define a chord extending between them, the chord being closer to the longitudinal axis of the guide channel than the chord drawn between the other first portion of the positioning support and the other first portion of the further positioning support. (10) The apparatus according to Embodiment 1, wherein one or more secondary positioning positions are provided by the one or more positioning elements, and one or more of the secondary positioning positions are in contact with the liner during use.

[0120] (11) A system, wherein the surgical system is Surgical instruments, A stem having a proximal end and a distal end, A handle portion provided toward the proximal end of the stem, A guide element provided toward the distal end of the stem, wherein the guide element is A main body element defining a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and A surgical instrument comprising a guide element that provides one or more positioning elements, and The aforementioned system, One or more cutting tools, A system further comprising one or more elongated, at least partially threaded elements. (12) The surgical system An actuator for applying torque to the cutting tool, One or more drill bits, The system according to embodiment 11, further comprising one or more self-tapping screw threads. (13) The system according to embodiment 12, wherein the guide channel of the surgical instrument is configured to receive the cutting tool, and the cross-section of the guide channel has clearance added to the cross-section of the cutting tool. (14) The system according to embodiment 13, wherein one or more or all of the positioning elements include one or more liner penetration portions. (15) The system according to embodiment 11, wherein two or more positioning elements are provided, and each positioning element includes a liner penetration portion toward its distal end.

Claims

1. Surgical instruments, A stem having a proximal end and a distal end, A handle portion provided toward the proximal end of the stem, The stem includes a guide element provided toward the distal end, and the guide element is A main body element defining a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and The present invention provides one or more positioning elements extending from between the main body element and the distal end of the stem, A surgical instrument in which at least one of the one or more positioning elements includes a curved element and / or curved edge provided toward the distal end of the at least one positioning element, the curved element and / or curved edge projecting toward the longitudinal axis of the guide channel at a position distal to the main element, thereby providing teeth for penetrating the liner.

2. The surgical instrument according to claim 1, wherein the guide channel is adapted to receive a cutting tool, and the longitudinal axis of the guide channel corresponds to the axis of motion of the cutting tool in use.

3. The surgical instrument according to claim 2, wherein the guide channel is adapted to restrict the radial movement of the cutting tool and to allow the axial movement of the cutting tool relative to the guide channel.

4. The surgical instrument according to claim 3, wherein one or more or all of the one or more positioning elements include one or more teeth.

5. The surgical instrument according to claim 3, wherein two or more positioning elements are provided, and the teeth are provided at the distal end of each positioning element.

6. The surgical instrument according to claim 5, wherein two of the teeth are provided to each of the positioning elements.

7. The surgical instrument according to claim 1, wherein a pair of positioning elements extend from both sides of the main body element to define a positioning support, and two or more teeth are provided on the positioning support.

8. The surgical instrument according to claim 1, wherein when the tooth penetrates the liner, the guide element is positioned on the liner.

9. The surgical instrument according to claim 1, wherein two positioning elements are provided, the distal end of a first positioning element and the distal end of a second positioning element define a chord extending between them, and the chord is closer to the longitudinal axis of the guide channel than a chord drawn between the other part of the first positioning element and the other part of the second positioning element.

10. The surgical instrument according to claim 1, wherein the curved element and / or curved edge abuts against the peripheral wall of the liner during use, and the distal end of the main body element abuts against the circumferential end surface of the liner during use.

11. A surgical system, wherein the surgical system is Surgical instruments, A stem having a proximal end and a distal end, A handle portion provided toward the proximal end of the stem, A guide element provided toward the distal end of the stem, wherein the guide element is A main body element defining a guide channel, wherein the guide channel has a longitudinal axis and both ends are open along the longitudinal axis, and A surgical instrument comprising: a guide element providing one or more positioning elements extending from between the main body element and the distal end of the stem, wherein at least one of the one or more positioning elements includes a curved element and / or curved edge provided toward the distal end of the at least one positioning element, the curved element and / or curved edge projecting toward the longitudinal axis of the guide channel at a position distal to the main body element, thereby providing teeth for penetrating the liner; One or more cutting tools, A surgical system comprising one or more elongated surgical tools, each being at least partially threaded.

12. The aforementioned surgical system An actuator for applying torque to the cutting tool, One or more drill bits, The surgical system according to claim 11, further comprising one or more self-tapping screw threads.

13. The surgical system according to claim 12, wherein the guide channel of the surgical instrument is configured to receive the cutting tool.

14. The surgical system according to claim 13, wherein one or more or all of the one or more positioning elements include one or more teeth.

15. The surgical system according to claim 11, wherein two or more positioning elements are provided, and the teeth are provided at the distal end of each positioning element.

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