Improvements in and relating to devices for implanting surgical instruments - Patents.com

Abstract

A surgical instrument inserter device (100), kits featuring same, and methods of use are provided. The inserter device comprises a body (109), a first attachment location at a proximal end (105) of the body, and a second attachment location at a distal end (103) of the body, the second attachment location including a contact element (149) for a surgical instrument to be inserted during use, the contact element having one or more non-planar contact surface segments. This allows for various orientations of the inserter device.

Description

[Technical field]

[0001] The present disclosure relates generally to orthopedic devices, kits including such devices, and methods of using such devices, and more particularly to orthopedic surgical instrument implantation devices, kits including such devices, and methods of using such devices. [Background technology]

[0002] Arthroplasty is a well-known surgical procedure in which diseased and / or damaged natural joints are replaced by artificial joints. Examples include artificial knee and hip joint implants. Surgical instruments are used to prepare the bone for receiving further surgical instruments and / or implants, and reliable implantation devices for these surgical instruments are desirable. Summary of the Invention [Means for solving the problem]

[0003] According to a first aspect of the present disclosure, there is provided a surgical instrument inserter apparatus comprising: The main body, a first attachment location provided at a proximal end of the body; a second attachment location provided at a distal end of the body; The second mounting location includes a contact element for a surgical instrument to be inserted therein during use, the contact element having one or more non-planar contact surface segments.

[0004] The contact element may include a plurality of separate non-planar contact surface segments. In particular, the contact element may provide a single non-planar contact surface. One or more or all of the non-planar contact surfaces may be articulating surfaces. One or more or all of the non-planar contact surface segments may be curved and / or partial sphere contact surface segments. One or more or all of the contact surface segments may be provided by a continuous surface. One or more or all of the contact surface segments may be provided by a deformed partial sphere. The deformed partial sphere may be partial due to the absence of a portion of the sphere, for example due to a portion of one side of a surface, such as a plane, being removed. The deformed partial sphere may be deformed due to a radius in one set of directions being reduced compared to a radius in another set of directions. The deformed partial sphere may be, for example, a compressed sphere compressed along one axis.

[0005] One or more non-planar contact surface segments may be provided adjacent a junction between the second attachment location and the body, for example adjacent a junction between the contact element and the elongated portion.

[0006] One or more non-planar contact surface segments may be provided distal to a junction between the second attachment location and the body, e.g., opposite a junction between the contact element and the elongated portion. One or more non-planar contact surface segments may be provided opposite a junction between the second attachment location and the body, e.g., opposite a junction between the contact element and the elongated portion.

[0007] The contact element may comprise one or more other contact surface sections. The contact element may comprise one or more near-planar or planar other contact surface sections. The one or more other contact surface sections may be sections of the same continuous surface of which the one or more non-planar contact surface sections are part.

[0008] The one or more other contact surface sections may be provided in one or both pole regions, for example along an axis passing through the contact element, in particular an axis perpendicular to the axis of the longitudinal axis of the inserter device. The contact element may comprise two flattened other contact surface sections, for example flattened compared to the curvature of the one or more non-planar contact surface sections. The two flattened other contact surface sections may be opposite each other. The contact element may comprise two flat other surface sections. The contact element may comprise at least two flat other surfaces that are coplanar with each other and / or extend parallel to the longitudinal axis of the inserter device.

[0009] The contact element may have the profile of a sphere with one or more spherical caps removed. The plane defining the first detached spherical cap may be a plane forming a joint between the contact element and the elongated portion. The plane defining the second detached spherical cap may be, for example, a first flat other surface that is flush with the second flat other surface and / or extends parallel to the longitudinal axis of the inserter device. The plane defining the third detached spherical cap may be, for example, a second flat other surface that is flush with the first flat other surface and / or extends parallel to the longitudinal axis of the inserter device. The plane defining the first detached spherical cap may contact and / or intersect the plane defining the second detached spherical cap. The plane defining the first detached spherical cap may contact and / or intersect the plane defining the third detached spherical cap.

[0010] The contact element may have a first range between a first pair of points on opposite sides of the contact element and a second range between a second different pair of points on different sides of the contact element, the first range being wider than the second range.

[0011] The contact element may have a first extent, for example between a first pair of points on either side of the contact element, and a second extent, for example between a second, different pair of points on either side of the contact element.

[0012] The first range may be broader than the second range. The first range may be at least 5% greater than the second range. The first range may be at least 10%, or at least 15%, or at least 20% greater than the second range.

[0013] The first range may be between a first pair of points on two different non-planar surfaces, for example, two non-planar surfaces opposite each other and / or two non-planar surfaces on opposite sides of the contact element.

[0014] The second range may be between a second pair of points on two different near-flat or flat surface sections, for example, on two near-flat or flat surfaces that are coplanar with each other and / or extend parallel to the longitudinal axis of the inserter device.

[0015] The first range and / or the second range may be considered along an axis and / or in a plane perpendicular to a longitudinal axis of the inserter device and / or the body portion. The first range may be considered along an axis perpendicular to a first non-planar point and / or perpendicular to a second non-planar point. The second range may be considered along an axis and / or in a plane perpendicular to the plane of the first surface segment and / or perpendicular to the plane of the second surface segment.

[0016] References to perpendicular herein may include perpendicular to + / - 10°, or + / - 8°, or + / - 5°, or + / - 3° in one or more or all of these examples.

[0017] The body may include a body portion. The body may include an elongated portion. The body may include a transition portion. The transition portion may connect the body portion to the elongated portion.

[0018] The first attachment location may be provided by the body portion, in particular on the proximal end of the body portion.

[0019] The second attachment location may be provided on the elongate portion, in particular on the distal end of the elongate portion.

[0020] The first attachment location may be adapted to connect an inserter apparatus to a distal end of the tool.

[0021] The first attachment location may include a stem. The stem may extend from the body, e.g., from the body portion, along an axis that is coaxial with the body portion and / or the proximal portion of the elongated portion. The first attachment location may provide a recess for receiving one or more components of the tool. The first attachment location may provide a recess that is partially defined by a proximal end of the stem. The stem may be provided with one or more alignment surfaces. The stem may be provided with one or more non-circular, e.g., planar, alignment surfaces. The alignment surfaces may be parallel to but extend away from the axis of the stem.

[0022] The first attachment location may be adapted to connect to, e.g., insert into, a distal end of a tool. The first attachment location may be adapted to engage with a latch-type mechanism on the tool, e.g., a releasable protrusion into a recess in a stem.

[0023] The first mounting position may have a tool engaged state and a tool disengaged state, and the first mounting position may be transitioned from the tool engaged state to the tool disengaged state and / or from the tool disengaged state to the tool engaged state by relative axial movement of the tool and the inserter apparatus.

[0024] The inserter device may, for example, have a longitudinal axis adapted to align with the longitudinal axis of the tool.

[0025] The body may include a first cross-sectional area portion and a second cross-sectional area portion closer to a distal end of the inserter device. The body portion may include the first cross-sectional area portion. The elongated portion may include the second cross-sectional area portion. The body may include a third cross-sectional area portion. The transition portion may include the third cross-sectional area portion.

[0026] The first cross-sectional area portion may have a larger cross-sectional area than the second cross-sectional area portion. The first cross-sectional area portion may have a larger cross-sectional area than the third cross-sectional area portion.

[0027] The first cross-sectional area portion may have a circular cross-sectional area. The first cross-sectional area portion may have a partially circular cross-sectional area. The first cross-sectional area portion may include two or more linear portions about its periphery. The two or more linear portions may be disposed opposite one another and / or parallel to one another.

[0028] The second cross-sectional area portion may open, particularly at its distal end, to a second attachment location.

[0029] The second cross-sectional area portion may have a smaller cross-sectional area than the third cross-sectional area portion.

[0030] The second cross-sectional area portion may have a circular cross-sectional area along at least a portion of its length, for example along a linear section.

[0031] The third cross-sectional area portion may have a circular cross-sectional area.

[0032] The body, e.g., the body portion, may be or may include a cylindrical portion. The body portion may include one or more planar surfaces. One or more pairs of planar surfaces may be provided, e.g., the pair of planar surfaces may be opposed to each other. The planar surfaces may be provided parallel to a longitudinal axis of the inserter device.

[0033] The body, e.g., the transition portion, may be or may include a conical portion. The transition portion may transition from the shape and configuration of the body portion to the shape and configuration of the elongated portion.

[0034] The body, e.g., elongated portion, may be or may include a cylindrical portion. The body, e.g., elongated portion, may be or may include a neck portion.

[0035] The elongated portion may have a linear section disposed between the proximal and distal ends. The elongated portion may extend at least adjacent the proximal end. The linear section may extend from the proximal end.

[0036] The elongated portion may have a linear section and a non-linear section disposed between the proximal end and the distal end. The non-linear section may extend from the linear section toward the distal end. The non-linear section may extend to or adjacent the distal end. The non-linear section may extend to a junction between the elongated portion and the second attachment location.

[0037] The non-linear section may include a first linear portion, a curved portion, and a second linear portion. The non-linear section may include a curved portion. The curved portion may bend away from the first axis at the first portion. The curved portion may bend towards the second axis at the second portion. The second axis may be parallel to the first axis but spaced apart from the first axis. The first axis may be coaxial with the longitudinal axis of the first linear portion and / or the elongated portion and / or the inserter device and / or the tool. The second axis may be offset relative to the longitudinal axis of the first linear portion and / or the elongated portion and / or the inserter device and / or the tool. The compression axis of the contact element may lie on the second axis and may be perpendicular to the second axis. The curved portion may have an intermediate portion between the first portion and the second portion. The intermediate portion may be curved. The intermediate portion may include an inflection point between the away curve and the toward curve. The intermediate portion may be or include a linear portion, for example, to contribute to the offset of the second axis from the first axis.

[0038] The non-linear section may include a first linear portion, an intermediate linear portion, and a second linear portion. The non-linear section may include an intermediate linear portion, which may be angled relative to the first linear portion and / or the elongated portion and / or a longitudinal axis of the inserter device and / or tool to provide the non-linear section.

[0039] In alternative embodiments, the elongate portion may have a linear section extending from a proximal end to a distal end, and potentially a second attachment location provided by or connected to the distal end. The proximal end and / or the distal end and / or the second attachment location may be on a common axis, for example a common axis with the longitudinal axis of the tool in use.

[0040] The elongated portion may have a first cross-section, e.g., a circular cross-section, and in particular may be provided along the length of the elongated portion starting from the proximal end and spanning at least 60% of the distance from the proximal end of the elongated portion toward the distal end of the elongated portion.

[0041] The elongated portion may have a second cross-section, e.g., a non-circular cross-section. The second cross-section may be provided along the length of the elongated portion, particularly starting from the distal end and spanning at least 10% of the distance from the distal end of the elongated portion toward the proximal end of the elongated portion. The second cross-section may include one or more flats, e.g., two flats opposite each other, that provide a portion of the circumference of the cross-section.

[0042] The elongated portion, and in particular its distal end section, may be provided with a planar surface, such as a flat, extending therealong.The elongated portion, and in particular its distal end section, may be provided with a pair of opposing planar surfaces.

[0043] The distal end of the elongated portion may be provided with a different cross-section than the elongated section, for example at the junction between the elongated portion and the second attachment location. The distal end of the elongated portion may be provided with a different cross-section than the first cross-section and / or the second cross-section, for example at the junction between the elongated portion and the second attachment location. The different cross-section may be, for example, an ellipse with linear sides. The different cross-section may provide a flared cross-section compared to the first cross-section and / or the second cross-section.

[0044] The distal end of the elongated portion may potentially include adjacent portions of the elongated portion to provide a flared section. The flared section may be flared in an outward direction and / or inward direction. The flared section may be flared in a direction of the first axis relative to the second axis, potentially in a direction away from the first axis.

[0045] The inserter device may have a tool disengaged state. The inserter device may have a tool engaged state. The inserter device may have an instrument non-contacting state. The inserter device may have an instrument contacting state. The inserter device may have an alternative orientation state. The inserter device may have an instrument insertion state.

[0046] The tool disengaged state may provide the inserter apparatus spaced from the tool. The tool engaged state may provide the inserter apparatus mounted on the tool. The tool engaged state may provide a constraint against movement of the inserter apparatus axially away from the tool.

[0047] The inserter device may pass through a first transition stage between a tool disengaged state and a tool engaged state, and the inserter device and the tool may be advanced axially towards each other in the first transition stage.

[0048] The instrument disengaged state may provide the inserter device mounted on a tool and / or spaced apart from the instrument.

[0049] The instrument contacting state may provide a second attachment location in contact with a portion of the inserter device, e.g., a portion of the instrument. The second attachment location may be partially or fully inserted into the instrument. The instrument contacting state may provide no constraint against movement of the inserter device and / or the instrument axially away from each other. The instrument contacting state may provide a constraint against rotation of the inserter device relative to the instrument.

[0050] The inserter device may go through a second transition stage between the instrument disengaged state and the instrument engaged state. The inserter device and the instrument may be advanced axially toward one another during the second transition stage. The inserter device and the instrument may not be rotated relative to one another during the second transition stage.

[0051] The inserter device may have one or more alternative orientation states, particularly while in the instrument contact state, which may be different angles of the longitudinal axis of the inserter device relative to the direction of movement during the second transition phase and / or relative to the longitudinal axis of the instrument and / or relative to an axis or plane parallel to the longitudinal axis of the instrument.

[0052] The inserter device may have a range of alternative orientations that lie within an articulation plane. The articulation plane may extend medial-lateral. The articulation plane may extend between the first and second axes of the curved sections.

[0053] The inserter device may have a second limited range of alternative orientations in another plane, e.g., a non-articulation plane. The non-articulation plane may extend anterior-posterior. The non-articulation plane may extend perpendicular to a plane extending between the first and second axes of the curved section.

[0054] The inserter device may have a series of alternative orientations, particularly over a range of orientations in the articulation plane that spans an arc of more than 10°, such as more than 20°, such as more than 30°, or even up to an arc of 45°. The inserter device may have a series of alternative orientations, particularly over a range of orientations in the articulation plane that spans an arc of less than 60°, such as less than 50°. The inserter device may have a series of alternative orientations, particularly over a range of 0° to 10° medially relative to the longitudinal axis of the instrument and / or to an axis or plane parallel to the longitudinal axis of the instrument. The inserter device may have a series of alternative orientations, particularly over a range of 20° to 50°, such as 30° to 40° transversely relative to the longitudinal axis of the instrument and / or to an axis or plane parallel to the longitudinal axis of the instrument. One or more of the alternative orientation states may provide a restraint against movement of the inserter device and / or the instrument axially away from one another.

[0055] The inserter device may have a limited set of second, limited alternative orientation states, particularly over a range of orientation states in the non-articulation plane that spans an arc of less than 10°, e.g., less than 5°, e.g., less than 3°, or even less than 1°. The inserter device may have a limited set of second, limited alternative orientation states, particularly over a range of orientation states in the posterior and / or anterior direction that spans an arc of less than 10°, e.g., less than 5°, e.g., less than 3°, or even less than 1°.

[0056] The inserter device may be moved from one alternative orientation, particularly an orientation in the plane of articulation, to another alternative orientation, for example by rotating the inserter device relative to the instrument in a medial or lateral direction.

[0057] The instrument insertion state may provide an axial load on the inserter device towards the instrument. The axial load may be applied via a tool. The axial load may be constant or may vary. The instrument insertion state may provide for relative motion between the instrument and the patient.

[0058] The body, e.g., the body portion, may be provided with one or more visible indicators of the orientation of the first attachment position. The one or more visible marks may indicate alignment or misalignment with the tool, e.g., rotation. The visible indicators may be one or more surfaces on the body portion. The visual indicators may be on the exterior of the instrument and / or may be visible in all states and stages.

[0059] The first aspect may include any of the features, possibilities, or options described elsewhere in this document, including other aspects.

[0060] According to a second aspect of the present disclosure, there is provided a kit, comprising: 1. A surgical instrument inserter apparatus, comprising: The main body, a first attachment location provided at a proximal end of the body; a second attachment location provided at a distal end of the body; a surgical instrument inserter apparatus, the second mounting location including a contact element for a surgical instrument to be inserted in use, the contact element further including one or more non-planar contact surface segments; The kit is The kit further comprises a tool for mounting the surgical instrument to the first mounting location of the inserter apparatus.

[0061] The tool may further include, for example, a handle towards the proximal end of the tool. The tool may further include one or more abutment surfaces, for example one or more radially extending elements or flanges, particularly at the proximal end of the tool. The one or more abutment surfaces may be adapted for impact by a further tool.

[0062] The tool may be provided with an inserter device mounting location. The inserter device mounting location may be a complementary mounting location to the first mounting location of the inserter device. The inserter device mounting location may include a bore. The bore may extend into the tool. The inserter device mounting location may include a releasable retaining element, such as a latch mechanism. The inserter device mounting location may be adapted to connect to, e.g., receive, a proximal end of the inserter device.

[0063] The inserter device mounting position may have an inserter device engaged state and an inserter device disengaged state. The inserter device mounting position may be transitioned from the inserter device engaged state to the inserter device disengaged state and / or from the inserter device disengaged state to the inserter device engaged state by axial movement of the inserter device and the tool relative to one another. The inserter device mounting position may be transitioned from the inserter device engaged state to the inserter device disengaged state and / or from the inserter device disengaged state to the inserter device engaged state by a releasable engagement operation.

[0064] The tool may be adapted to perform one or more additional functions in addition to contacting the inserter device: the tool may also function as an instrument extraction device for use in removing the stem.

[0065] The second aspect of the invention may include any of the features, possibilities or options described elsewhere herein in relation to an inserter device comprising the first aspect in particular. The second aspect may include any of the features, possibilities or options described elsewhere herein, including other aspects.

[0066] According to a third aspect of the present disclosure, there is provided a surgical instrument including a tapered body extending distally from a first end to a second end, one or more sections of the tapered body are provided with a plurality of cutting teeth, and an instrument mounting location is provided on a top surface of the tapered body, the mounting location being provided within an opening, the opening including one or more contact surfaces, at least one of the contact surfaces being a non-planar contact surface.

[0067] The device may be an implant.

[0068] The appliance may have an upper portion. The upper portion may be provided with a series of teeth and / or recesses, in particular teeth alternating with recesses. The appliance may have a protruding surface. The protruding surface may be provided with protrusions, e.g. spigots, for receiving a trial or part of a trial. The protruding surface may comprise an opening.

[0069] The opening may be a slot. The slot may be a closed ended slot. The slot may be an open ended slot, for example at the inner end. The opening may be a through hole. The opening may be a through hole connected to a second through hole in the underside of the broach. The opening may be defined in part by one or more surrounding walls. The opening may be defined in part by one or more bottom walls.

[0070] The opening may provide a recess into the device, for example below a surrounding wall that defines the opening. The chamber may be defined in part by one or more side walls and / or a bottom wall.

[0071] The opening may have a width that is considered anterior-posterior, but this width is less than the length of the opening that is considered medial-lateral. The opening may have a second extent that is considered anterior-posterior, but this second extent is less than the first extent that is considered medial-lateral.

[0072] The first extent of the opening may be greater than the first extent of the inserter device.The second extent of the opening may be greater than the second extent of the inserter device.

[0073] The opening may provide one or more contact surfaces for one or more surfaces of the second mounting location of the inserter device. The one or more contact surfaces may provide articulation surfaces, for example, to allow rotation of the inserter device relative to the instrument. The opening may provide one or more non-planar sections, for example, complementary to one or more non-planar sections of the inserter device. The base of the opening may provide one or more non-planar sections, for example, complementary to one or more non-planar sections of the inserter device. The ends, for example, side ends of the opening, may provide one or more non-planar sections, for example, complementary to one or more non-planar sections of the inserter device. The side walls of the opening may provide one or more non-planar sections, for example, complementary to one or more non-planar sections of the inserter device.

[0074] The openings may limit, for example by abutment, the range of possible variations in axial alignment of the tool and / or inserter device.

[0075] The appliance may include one or more teeth and / or recesses, for example on the anterior and posterior surfaces. The appliance may include spaces without teeth or recesses on or near the lateral shoulder surfaces, for example with alpha / number markings.

[0076] The third aspect may include any of the features, possibilities, or options described elsewhere in this document, including other aspects.

[0077] According to a fourth aspect of the present disclosure, there is provided a method of inserting a surgical instrument through a patient, the method comprising: 1) providing a surgical instrument inserter device, the inserter device comprising: The main body, a first attachment location provided at a proximal end of the body; a second attachment location provided at a distal end of the body; The second mounting location includes a contact element for a surgical instrument to be inserted therein during use, the contact element having one or more non-planar contact surface segments. 2) inserting a contact element of the inserter device into an opening in the surgical instrument to provide instrument contact; 3) Reducing the separation between the inserter device and the patient for inserting a surgical instrument in the patient.

[0078] The method may include a tool disengagement state for the inserter apparatus.The method may include a tool engagement state.

[0079] The method may include an instrument disengaged state.The method may include an instrument contacted state.

[0080] The method may include alternative orientation states.The method may include an instrument insertion state.

[0081] The tool disengaged state may provide the inserter device spaced away from the tool.

[0082] The tool engaged state may provide the inserter apparatus mounted on the tool. The tool engaged state may provide a constraint against movement of the inserter apparatus axially away from the tool. The method may further include the step of connecting the tool to the inserter apparatus to provide the tool engaged state. The tool may be connected to the inserter apparatus before step 2) is commenced.

[0083] The method may include passing the inserter apparatus through a first transition stage between a tool disengaged state and a tool engaged state. The method may include advancing the inserter apparatus and the tool axially toward each other during the first transition stage.

[0084] The instrument disengaged state may provide the inserter device mounted on a tool and / or spaced apart from the instrument.

[0085] The instrument contacting state may provide a second attachment location in contact with a portion of the inserter device, e.g., a portion of the instrument. The second attachment location may be partially or fully inserted into the instrument. The instrument contacting state may provide no constraint against movement of the inserter device and / or the instrument axially away from each other. The instrument contacting state may provide a constraint against rotation of the inserter device relative to the instrument.

[0086] The method may include passing the inserter device through a second transition stage between an instrument disengaged state and an instrument contacted state. The method may include the inserter device and / or the instrument being axially advanced toward one another during the second transition stage. The inserter device and the instrument may not be rotated relative to one another during the second transition stage.

[0087] The method may particularly include the inserter device having one or more alternative orientation states while in the instrument contact state, which may be different angles of the longitudinal axis of the inserter device relative to the direction of movement during the second transition stage and / or relative to the longitudinal axis of the instrument and / or relative to an axis or plane parallel to the longitudinal axis of the instrument.

[0088] The method may include the inserter device having a range of alternative orientations within an articulation plane. The articulation plane may extend medial-lateral. The articulation plane may extend between a first axis and a second axis of the curved portion.

[0089] The method may include the inserter device having a second limited range of alternative orientations in another plane, e.g., a non-articulation plane. The non-articulation plane may extend anterior-posterior. The non-articulation plane may extend perpendicular to a plane extending between the first and second axes of the curved section.

[0090] The method may include an inserter device having a series of alternative orientations over a range of orientations spanning an arc of more than 10°, e.g., more than 20°, e.g., more than 30°, or even up to an arc of 45°. The method may include an inserter device having a series of alternative orientations over a range of orientations spanning an arc of less than 60°, e.g., less than 50°. The method may include an inserter device having a series of alternative orientations over a range of 0° to 10° medially relative to the longitudinal axis of the instrument and / or to an axis or plane parallel to the longitudinal axis of the instrument. The method may include an inserter device having a series of alternative orientations over a range of 20° to 50°, e.g., 30° to 40° laterally relative to the longitudinal axis of the instrument and / or to an axis or plane parallel to the longitudinal axis of the instrument. The method may include the step of one or more alternative orientation states providing restraint against axial movement of the inserter device and / or the instrument away from one another.

[0091] The method may include the inserter device having a second limited set of alternative orientations, particularly over a range of orientations spanning an arc of less than 10°, e.g., less than 5°, e.g., less than 3°, or even less than 1°, in the non-articulation plane.The method may include the inserter device having a second limited set of alternative orientations, particularly over a range of orientations spanning an arc of less than 10°, e.g., less than 5°, e.g., less than 3°, or even less than 1°, in the posterior and / or anterior direction, in the non-articulation plane.

[0092] The method may include transitioning the inserter device from one alternative orientation, particularly an orientation in the articulation plane, to another alternative orientation, for example by rotating the inserter device in a medial or lateral direction relative to the instrument.

[0093] The method may include inserting the instrument in a number of different alternative orientations.

[0094] The method may include the instrument insertion state providing an axial load to the inserter device towards the instrument. The axial load may be applied via a tool. The axial load may be constant or may vary. The instrument insertion state may provide for relative motion between the instrument and the patient.

[0095] The fourth aspect may include any of the features, possibilities, or options described elsewhere in this document, including other aspects. [Brief description of the drawings]

[0096] Various embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying figures. [Figure 1a] FIG. 1 is a perspective view of a first embodiment of an inserter device. [Figure 1b] FIG. 2b is a detailed view of the distal end of the inserter device of FIG. 2a. [Figure 2a] FIG. 13 is a perspective view of a second embodiment of an inserter device connected to a tool, illustrating the range of articulation. [Figure 2b] FIG. 2b is a perspective view of the inserter device of FIG. 2a transmitting torque to an implant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097] While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail, It should be understood, however, that it is not the intention of this disclosure to limit the concepts of the present disclosure to the particular forms disclosed, but rather, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure and the appended claims.

[0098] Terms denoting anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, etc., may be used throughout this specification with respect to the orthopedic implants or prostheses and surgical instruments described herein, as well as with reference to the patient's natural anatomy. Such terms have well-understood meanings both in the study of anatomy and in the field of orthopedic surgery. Use of such anatomical reference terms in the written description and claims is intended to be consistent with their well-understood meanings, unless otherwise specified.

[0099] In hip arthroplasty, the femoral component of the prosthesis must be successfully introduced into the prepared proximal end of the femur. Although press-fit implants are frequently used, other forms of implants can also be deployed. For this purpose, an inserter device such as an impactor can be used.

[0100] Many designs provide a linear shaft for the device that engages with the implant such that the longitudinal axis of the shaft and the longitudinal axis of the implant are aligned, which is beneficial for efficient energy transfer from the shaft to the implant and / or to reduce the risk of damage to the implant and / or shaft.

[0101] In some cases, linear shafts encounter difficulties in their use due to the patient's anatomy and / or the degree of exposure provided at the surgical site limiting or preventing alignment.

[0102] The present disclosure seeks to provide the ability to accommodate a wider range of patient anatomies and site exposures. The present disclosure seeks to provide effective force transmission between the shaft and implant over a wide range of orientations. The present disclosure seeks to provide reliable contact between the shaft and implant.

[0103] A first embodiment of an inserter device 100 according to the present disclosure is shown in Figure 1a. The inserter device 100 is provided with a distal end 103 and a proximal end 105.

[0104] 2b, the proximal end 105 provides an attachment location 107 for connecting the inserter device 100 to a distal end 202 of a tool 200, such as an impactor device, for example. A variety of configurations for the attachment location 107 are possible, each having a suitable configuration for engaging with a configuration at the distal end 202 of the tool 200.

[0105] In the illustrated configuration of FIG. 1a, the proximal end 105 includes a body portion 109 that mounts a protruding element 111 of reduced diameter. The base 113 of the protruding element 111 has a flat surface 115 that aids in the correct orientation of the inserter device 100 when mounted on the tool 200. The flat surface 115 is received against a flat of similar contour in a bore in the distal end 202 of the tool 200. The protruding element 111 is generally cylindrical, but is provided with a cutout 117. A cylindrical cap 119 forms the proximal end 121 of the protruding element 111. The cap 119 cooperates with a latch-type mechanism of the tool 200 that fits into the cutout 117. This interaction limits axial movement of the tool 200 and the inserter device 100 relative to one another.

[0106] Indicia 110 are provided on body portion 109 to indicate alignment of inserter device 100 with tool 200 .

[0107] The transition section 123 provides a gradual taper from the body portion 109 and its profile to the reduced profile of the shaft 125 .

[0108] Shaft 125 includes a linear section 127 and a curved section 129. Linear section 127 is located closer to the proximal end 105 of inserter device 100 than curved section 125. Thus, curved section 129 is located closer to the distal end 103 of inserter device 100 than linear section 127.

[0109] The linear section 127 has a longitudinal axis LL that is coaxial with the axis of the body portion 109 and the projection elements 111. As can be seen in Figure 2b, the longitudinal axis TT of the tool 200 is also coaxial with this axis LL.

[0110] The cross section of linear section 127 coincides between its junction 131 and transition portion 123 until adjacent a junction 133 between linear section 127 and curved section 129. The cross section is circular throughout this coincident section. Through and adjacent junction 133 the cross section is partially circular but has two flat surfaces 155a, 155b (described further below).

[0111] lb, curved section 129 includes a first portion 135 having an axis AA that is coaxial with longitudinal axis LL of shaft 125. Curved section 129 includes a second portion 139 having an axis BB that is parallel to axis AA and also parallel to axis LL. The amount of offset 141 between axes AA and BB defines in part the curvature of curved section 129 and its ability to accommodate patient anatomy and / or surgical site exposure variations. A curved portion 143 intermediate first portion 135 and second portion 139 first curves away from axis AA and then curves back toward axis BB.

[0112] The distal end 145 of the curved section 129 provides a junction 147 between the curved section 129 and an end element 149 .

[0113] The cross-section of curved section 129 is congruent between junction 133 and linear section 127 until adjacent junction 147. The cross-section is partially circular, having a partially circular middle portion 151, partially circular lateral portions 153, and two flat surface sections 155a, 155b, one on each side of curved section 129. The two flat sections 155a, 155b extend proximally slightly beyond junction 133.

[0114] As best seen in Figure lb, flat surfaces 155a, 155b exist up to junction 147. However, from cross-sectional location 157 adjacent junction 147 to junction 147, part-circular section 153 and part-circular section 155 cease to be part-circular and instead gradually increase to provide a flared section 159 having an elongated (front-rear) cross-section, the function of which will be described below.

[0115] As can be seen in both Figures 1a and 1b, the inserter device 100 is provided at its distal end 103 with an end element 149.

[0116] In the illustrated embodiment, the end element 149 is in the shape of a portion of a compressed sphere. The direction of compression is along axis CC. The end element 149 has an equator 161 that extends around the end element 149 in a plane that intersects axis AA and also intersects axis BB. The end element 149 may have a polar region 163 around axis CC and / or around an axis perpendicular to equator 161. The polar region 163 may be flattened, as shown in Figures 1a and 1b. The curved section of the end element 149 allows the inserter device 100 to articulate relative to the implant, as described in more detail below. The compressed or flattened section of the end element 149 provides a more constrained orientation of the inserter device 100 relative to the implant in that direction. The portions of the flat surface sections 155a, 155b that are within the implant in use may comprise compressed or flattened sections of the end element 149, allowing a rotational torque to be applied to the implant to check its stability in the patient.

[0117] Various shapes of the end element are possible, providing a curved surface that provides the desired articulation in the desired direction, and / or providing a less curved or flatter surface that provides a greater constraint to articulation in another desired direction. For example, in one embodiment, relative to the center point of the end element 149, the outer surface of the end element 149 is defined by a first radius at the plane intersecting axis AA and also at the intersecting axis BB. This may be a plane extending outward-inward. The outer surface is defined by a second radius at the plane intersecting axis BB that extends perpendicular to the axis AA. This may be a front-back plane. The second radius is shorter than the first radius. Between the two planes, the radius may transition from the second radius to the first radius to provide an intermediate curvature.

[0118] As seen in Figure 2a, the inserter device 100 in use has a proximal end 105 connected to a distal end 202 of a tool 200. The tool 200 includes a handle section 204 having a through hole 206 that allows a surgeon to hold the tool 200 from a variety of orientations. The proximal end 208 of the tool 200 is provided with a surface 210 against which impact or pressure may be applied in order to advance an implant (not shown) into a patient using the inserter device 100. The tool 200 has an axis TT.

[0119] The tool 200 can be used with various interchangeable inserter devices 100, such as those shown in Figures 1a and 1b. In Figure 2a, a second embodiment of the inserter device 100 is shown. It has an end element 149, which has the shape, configuration and operation described above. However, in this case, although articulation is provided, the inserter device 100 is purely linear. The inserter device 100 therefore has a body portion 109 (and related elements described in detail above) and a transition section 123 leading to a reduced profile of the shaft 125. In this embodiment, the shaft 125 is only provided with a linear section 127. The linear section 127 has a longitudinal axis LL, which is coaxial with the axis of the body portion 109 and the protruding element 111, and which is coaxial with the axis TT of the tool 200.

[0120] The cross section of the linear section 127 coincides between its junction 131 and the transition section 123 until closer to the junction 147 between the linear section 127 and the end element 149. The cross section is circular throughout this coincident section, but closer to the junction 147 the cross section is partially circular but still has two flat surfaces 155a, 155b. Adjacent to the junction 147 there is again a flared section 159 having an elongated (front-rear) cross sectional section.

[0121] In the second embodiment, the end element 149 is again in the shape of a portion of a compressed sphere, as before. The direction of compression is along the axis CC as before, and the other end element 149 features are also present.

[0122] In FIG. 2 a , end element 149 is shown axially advanced towards protruding surface 302 of implant 300 .

[0123] The implant has an upper portion 304, visible in Figures 2a and 2b, which includes a series of grooves alternating with recesses to aid in retention of the implant with the remainder of the implant (not shown). The protruding surface 302 of the implant 300 extends medially-laterally when inserted into the femur. The protruding surface 302 is provided with a protrusion 306 for receiving a further implant (not shown).

[0124] The projection surface 302 defines a slot 308 that extends downwardly into the implant 300. The slot 308 is defined by a perimeter wall and a bottom wall. The slot 308 has a width that is a clearance size greater than the width of the end element 149 along the axis CC. The slot 308 has a width that may be considered anterior-posterior AP, but that is less than the length of the slot 308 that may be considered medial-lateral ML.

[0125] As shown in FIG. 2b, end element 149 is inserted into slot 308 with flats 155a, 155b and the flattened pole regions on end element 149 aligned with the anterior-posterior AP; thus, the reduced "width" of end element 149 in that orientation due to flats 155a, 155b and the flattened pole regions allows end element 149 to enter slot 308 and then contact one or more portions of the walls of slot 308.

[0126] If the flats 155a, 155b on the end element 149 are presented facing the outer-inner LM, then the full "width" of the end element 149 in that orientation means that the end element 149 cannot enter the slot 308 due to the fuller portion of the compressed sphere of the end element 149 being presented.

[0127] As shown in FIG. 2 b , end element 149 is within slot 308 and flared section 159 is outside slot 308 .

[0128] In the inserted state of FIG. 2b, any attempt to move the tool 200 and inserter device 100 in the proximal axial direction will result in a transition from the inserted state back to the disengaged state since there is no resistance to the movement and separation.

[0129] The slot 308 has an internal contour defined by a perimeter wall and a bottom wall that provide one or more at least partially complementary surfaces that contact the end element 149 of the inserter device 100. As described above, the shape and configuration provided on the end element 149 is a compressed sphere, and thus a similar female surface within the slot 308 allows a range of alternative orientations for the inserter device 100 and tool 200 relative to the implant 300. With reference to FIG. 2a, the range is illustrated by the grey shaded arc 400a-400b. The range extends medially and laterally over an arc of approximately 40°. Little or no articulation is permitted in other directions, such as anterior-posterior, due to the flattened polar regions of the end element 149 and the corresponding portions of the slot walls that form flatter surfaces that do not support relative articulation.

[0130] Facilitated articulation allows the tool 200 and / or the inserter device 100 to avoid the patient's anatomy and / or operate within the limitations of surgical site exposure.

[0131] 2b, when an impact is applied to the surface 210 of the tool 200, the force is then transmitted through the tool 200 to the inserter device 100 and thus to the implant 300. The contours of the slot 308 and the end element 149 are designed to be largely complementary to each other, so that the force is transmitted over a large area. This reduces the possibility of damage to the inserter device 100 and / or the implant 300. The contours of the slot 308 and the end element 149 are designed to be largely complementary to each other over a full range of alternative orientation states, so that an optimized force transmission is provided even when the axis of the tool 200 and / or the inserter device 100 is not aligned with the axis of the implant 300.

[0132] Referring to the insertion state of FIG. 2b, if the tool 200 and inserter device 100 are rotated in either direction, then a rotational torque is applied to the implant because the width of the slot 308 is very close to the width of the end element 149 and does not allow substantial relative rotation of the inserter device 100 and implant 300.

[0133] When the inserter device 100, and thus the end element 149, reaches the limit of the arc of the alternate orientation, then the flared section 159 will abut against the periphery of the slot 308, thus providing tactile feedback to the surgeon that the full range of tilt of the inserter device relative to the implant has been reached.

[0134] While the present disclosure has been illustrated and described in detail in the drawings and foregoing description, it is understood that such illustration and description is merely illustrative in nature and should not be regarded as restrictive, and that merely illustrative embodiments have been shown and described, and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.

[0135] There are several advantages of the present disclosure that derive from the various features of the devices, systems, and methods described herein. It should be noted that alternative embodiments of the devices, systems, and methods of the present disclosure may not include all of the features described, but will benefit from at least some of the advantages of such features. Those skilled in the art may readily devise their own implementations of the devices, systems, and methods that incorporate one or more of the features of the present invention and are within the spirit and scope of the present disclosure.

[0136] [Embodiment] (1) A surgical instrument inserter apparatus, comprising: The main body, a first attachment location at the proximal end of the body; and a second attachment location provided at the distal end of the body; A surgical instrument inserter apparatus, wherein the second mounting location includes a contact element for the surgical instrument to be inserted during use, the contact element having one or more non-planar contact surface segments. (2) The inserter device of claim 1, wherein the contact element provides a single, non-planar contact surface. (3) The inserter device of any one of claims 1 to 2, wherein the non-planar contact surface is a curved contact surface. (4) An inserter device according to any one of claims 1 to 3, wherein one or more or all of the non-planar contact surface segments are articulating surfaces. (5) An inserter device as described in any one of claims 1 to 4, wherein one or more or all of the contact surface segments are provided by a deformed partial sphere.

[0137] (6) An inserter device as described in any one of claims 1 to 5, wherein one or more or all of the contact surface segments are provided by compressed spheres, the compression being along one axis. (7) An inserter device according to any one of embodiments 1 to 6, wherein the contact element includes one or more other contact surface sections, the one or more other contact surface sections being one or more near-flat or flat other contact surface sections. (8) The inserter device of embodiment 7, wherein the one or more other contact surface sections are sections of the same continuous surface of which the one or more non-planar contact surface sections are a part. (9) An inserter device according to any one of claims 1 to 8, wherein the contact element comprises two other contact surface segments that are flattened compared to the curvature of the one or more non-planar contact surface segments. (10) An inserter device as described in embodiment 9, wherein the two other flattened contact surface sections are opposite each other and are on the rear and front sides of the inserter device.

[0138] (11) An inserter device according to any one of embodiments 1 to 10, wherein the contact element has a first range and a second range, the first range being between a first pair of points on opposite sides of the contact element, the second range being between a second different pair of points on different sides of the contact element, and the first range being wider than the second range. (12) The inserter device of any one of claims 1 to 11, wherein the body includes a body portion and an elongated portion, together with a transition portion connecting the body portion to the elongated portion. (13) An inserter device according to any one of embodiments 1 to 12, wherein the first mounting location is adapted for connecting the inserter device to the distal end of a tool. (14) A kit comprising: 1. A surgical instrument inserter apparatus, comprising: The main body, a first attachment location at the proximal end of the body; and a second attachment location provided at the distal end of the body; a surgical instrument inserter apparatus, the second mounting location including a contact element for the surgical instrument to be inserted in use, the contact element having one or more non-planar contact surface segments; The kit comprises: The kit further comprises a tool for mounting the surgical instrument inserter apparatus to the first mounting location. (15) The kit of embodiment 14, wherein the tool further comprises a handle and / or one or more abutment surfaces and / or is adapted for impact with an additional tool.

[0139] (16) The kit of any one of claims 14 to 15, further comprising an inserter device having a plurality of different configurations.

Claims

1. 1. A surgical instrument inserter apparatus, comprising: The main body, a first attachment location at the proximal end of the body; and a second attachment location provided at the distal end of the body; A surgical instrument inserter apparatus, wherein the second mounting location includes a contact element for the surgical instrument to be inserted during use, the contact element having one or more non-planar contact surface segments.

2. The inserter device of claim 1 , wherein the contact element presents a single, non-planar contact surface.

3. The inserter device of claim 1 or 2, wherein the non-planar contact surface is a curved contact surface.

4. The inserter device of claim 1 , wherein one or more or all of the non-planar contact surface segments are articulating surfaces.

5. The inserter device of claim 1 , wherein one or more or all of the contact surface segments are provided by a deformed partial sphere.

6. The inserter device of claim 1 , wherein one or more or all of the contact surface segments are provided by compressed spheres, the compression being along one axis.

7. The inserter device of claim 1 , wherein the contact element includes one or more other contact surface sections, the one or more other contact surface sections being one or more near-flat or flat other contact surface sections.

8. The inserter device of claim 7 , wherein the one or more other contact surface segments are segments of the same continuous surface of which the one or more non-planar contact surface segments are a part.

9. The inserter device of claim 1 , wherein the contact element comprises two other contact surface segments that are flattened compared to a curvature of the one or more non-planar contact surface segments.

10. 10. The inserter device of claim 9, wherein the two other flattened contact surface sections are opposite each other and are on the rear and front sides of the inserter device.

11. 2. The inserter device of claim 1, wherein the contact element has a first range and a second range, the first range being between a first pair of points on opposite sides of the contact element and the second range being between a second different pair of points on different sides of the contact element, the first range being wider than the second range.

12. The inserter device of claim 1 , wherein the body includes a body portion and an elongated portion with a transition portion connecting the body portion to the elongated portion.

13. The inserter device of claim 1 , wherein the first mounting location is adapted for connecting the inserter device to the distal end of a tool.

14. A kit comprising:

1. A surgical instrument inserter apparatus, comprising: The main body, a first attachment location at the proximal end of the body; and a second attachment location provided at the distal end of the body; a surgical instrument inserter apparatus, the second mounting location including a contact element for the surgical instrument to be inserted in use, the contact element having one or more non-planar contact surface segments; The kit comprises: The kit further comprising a tool for mounting the surgical instrument inserter apparatus to the first mounting location.

15. 15. The kit of claim 14, wherein the tool further comprises a handle and / or one or more abutment surfaces and / or is adapted for impact with a further tool.

16. 16. The kit of claim 14 or 15, wherein the kit further comprises a plurality of inserter devices of different configurations.

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