Surgical instruments, reamer sets, and surgical methods

Abstract

A set of surgical instruments adapted for cutting bone and tissue material to prepare the surgical site for receiving artificial prostheses. This set includes multiple distal reamers, including subsets with different diameters and a common axial length, and corresponding sets of proximal reamers, also with different diameters and a common axial length. A complete modular instrument cutting assembly is provided, allowing for intraoperative changes between different implant types.

Description

Technical Field

[0001] The present disclosure relates to surgical instruments, sets incorporating such surgical instruments, and surgical methods of using such instruments. The present disclosure relates particularly, but not exclusively, to reaming / cutting instruments, specifically surgical site preparation reaming instruments.

Background Art

[0002] Orthopedic surgeons need to form openings or cavities in long bones for various reasons, including fracture fixation and implantation of prostheses using stems. The stem is used to fix an artificial prosthesis within a bone cavity in an artificial joint implant. The bone that will receive the stem is typically prepared by making a hole and forming an opening sized and shaped to receive the implant stem. Typically, for joint reconstruction, the stem is inserted into a cavity within the bone and extended outwardly to connect a joint support (head) provided on or coupled to the stem to a receiving socket or other area to complete the joint.

[0003] Reamers are often used to prepare bones such as the femur. Different types and / or sizes of surgical implants may be appropriate for a particular surgical problem or site, which may necessitate a change in the surgical plan. This can often require a number of instrument trays, as surgical implants typically come with a set of reamers for them and, in many cases, a set of different types of reamers. Additionally, the same reamer may be used to ream to various different depths depending on the size of the stem being implanted. A number of reamers means an undesirably large instrument inventory that must be maintained.

[0004] A reamer generally includes a rotary reamer with a cutting structure such as a flute, a body for the surgeon to hold the instrument, and a connector for connecting to a rotary drive source, often a power tool, but can also be manual. Often, the reamer is detachable from the instrument so that different sized reamers can be used, for example, to gradually increase the size of the cavity according to the patient's size or to fit the size of a planned prosthesis. Therefore, a releaseable mounting mechanism is often provided so that the reamer can be interchangeably attached to the rest of the reamer instrument so that different sized reamers can be used.

[0005] During hip replacement surgery, it is generally necessary to provide surgeons with some flexibility in the selection of prostheses. In particular, the anatomical structure of the bone into which the prosthesis is implanted may vary somewhat from patient to patient. Integrated or one-piece prostheses include a head (or head mount), stem, and neck that are formed integrally. Typically, there may be a range of different sizes of prostheses that surgeons can select to match the size of the patient's femur. For example, a patient's femur may be relatively long or relatively short, and it may be necessary to use a femoral prosthesis with a relatively long or relatively short stem accordingly. Furthermore, in certain cases, such as when a relatively long stem length is required, the stem must be bent to conform to the anatomical structure of the patient's femur. Modular prostheses are constructed in a modular form, so individual components can be selected to conform to the requirements of the patient's anatomical structure. For example, a typical modular prosthesis includes a proximal body component that can be assembled to any one of several distal stem components. Such a design allows for the selection of distal stem components, which are then implanted into the patient's bone at a position that conforms to the patient's anatomical structure, while also allowing for a degree of independent positioning of the proximal main body components. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, it is beneficial to reduce the number of required sets of surgical instruments and / or surgical reamers. Additionally, it would be beneficial to allow greater interchangeability between different types of implants in response to surgical assessments during the procedure and to determine if a second different implant or implant type may be more suitable than the first intended implant. Such interchangeability is advantageous if it can be achieved through a minimum number of surgical instruments, particularly bone preparation reamers. [Means for solving the problem]

[0007] The objective of this concept is to provide a set of surgical instruments, particularly reamers, for preparing surgical sites, with improved compatibility and interchangeability between different surgical instruments / reamers. Such a configuration is advantageous in that surgical sites can be prepared by using multiple instruments / reamers from this set in various different combinations. A further specific objective is to provide a set of surgical instruments / reamers adapted for use in any combination, particularly combinations that can be replaced during the surgical procedure, to prepare surgical sites to accept different types and / or sizes of implants. A further specific objective is to provide a set of instruments / reamers that can be used with the intention of preparing a surgical site to accept a first type of implant, while at the same time enabling the same prepared surgical site to be suitable for accepting a different second type of implant without requiring complete re-preparation of the site.

[0008] A further specific objective is to provide a set of surgical instruments having different groups of instruments / reamers, which can be interchangeably combined and used to prepare a surgical site to accept at least a first type of implant and a second type of implant. A further specific objective is to provide a set of surgical reamers organized into groups including distal reamers and proximal reamers, wherein the different groups of distal and proximal reamers have interchangeable compatibility.

[0009] These objectives are achieved by a set of surgical instruments, particularly reamers organized into proximal and distal reamer groups. Each group of reamers contains a set of reamers of the same common length but different diameters. Such configurations are provided for both distal and proximal reamer groups, and each group is optionally provided in a tray.

[0010] In particular, the surgical instrument / reamer set of the present invention is designed to be modular by the axial length and diameter of the distal and proximal ends of each cutting portion of each reamer. That is, the modular set of reamers of the present invention includes groups with fixed cutting portion lengths but different diameters, such that the diameter of either the distal or proximal end of different groups of reamers matches, overlaps, and / or is the same across all, some, or more different groups. The modular structure of the surgical instrument / reamer set of the present invention allows a surgeon to identify an implant that is suitable for the patient, particularly the patient's femur, in terms of length, especially gauge, and then identify the group of distal reamers needed to prepare the bone site as an initial step. The modular set of the present invention further allows a surgeon to initially select one or more different groups of proximal reamers to prepare the bone site as an intermediate or final step, while also allowing the surgeon to swap in different implants depending on the condition or circumstances of the patient's bone and / or surgical site. Specifically, this concept provides such interchangeability through the use of one or more reamers from a selected group of proximal reamers identified as compatible with and suitable for a second type of surgical implant identified by the surgeon, without the need to perform further / additional distal reaming or to complete preparation of the surgical site.

[0011] According to a first aspect of the present concept, a set of surgical reamers is provided, the set of surgical reamers comprising: a plurality of distal reamers each having a cutting portion extending between a distal tip and a proximal end, wherein the distal reamers comprise at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length greater by a module increment than the first axial length; and a plurality of proximal reamers each having a cutting portion extending between a distal end and a proximal end, wherein the proximal reamers comprise at least a first group having different diameters and a common first axial length, and a second group having different diameters and a proximal reamer greater by the module increment than the first axial length of the proximal reamer. The distal reamer and proximal reamer are configured such that the proximal end of the first group of distal reamers can be positioned adjacent to the distal ends of the proximal reamers of the first and second groups, and the distal end of the proximal reamer of the second group can be positioned adjacent to the proximal ends of the proximal reamers of the first and second groups, such that the combined axial lengths of the cutting portions of the proximal reamers of the first group and the distal reamers of the first group, the proximal reamers of the second group and the distal reamers of the first group, and the proximal end of the proximal reamers of the second group can be positioned adjacent to the proximal ends of the proximal reamers of the first and second groups, such that the proximal end of the proximal reamer of the first group and the distal reamer of the second group can be positioned adjacent to the proximal ends of the distal reamers of the first and second groups, such that the combined axial lengths of the cutting portions of the proximal reamers of the first group and the distal reamers of the first group and the distal reamers of the second group differ from each other by at least one of the above module increment values.

[0012] References to module increments in this specification include qualitative and quantitative axial lengths measured between two spatially separated axial locations. Module increments may be integers or fixed decimal values. Module increments may be measured from any one axial end of the cutting portion described herein, such ends of the cutting portion include the distal cutting tip, as well as the proximal and distal ends.

[0013] Optionally, the diameter of the distal end of at least one cutting portion of the proximal reamers of the first group is equal to or approximately equal to the diameter of the proximal end of at least one cutting portion of the distal reamers of the first group; the diameter of the distal end of at least one cutting portion of the proximal reamers of the second group is equal to or approximately equal to the diameter of the proximal end of at least one cutting portion of the distal reamers of the first group; and the diameter of the distal end of at least one cutting portion of the proximal end of at least one cutting portion of the proximal reamers of the second group is equal to or approximately equal to the diameter of the proximal end of at least one cutting portion of the distal reamers of the second group.

[0014] Optionally, the distal reamer has a diameter increase according to a tapered profile between the distal and proximal ends of each cutting portion. Optionally, the proximal reamer has a diameter increase according to a tapered profile between the proximal ends of each cutting portion.

[0015] Optionally, each cutting portion includes flutes extending at least axially and / or circumferentially along each respective cutting portion.

[0016] Optionally, a set of surgical reamers includes at least three groups of distal reamers, comprising a first group, a second group, and a third group having different diameters and a common axial length greater by the above module increment value than the axial length of the distal reamers of the second group. Optionally, a set of surgical reamers includes at least three groups of proximal reamers, comprising a first group, a second group, and a third group having different diameters and a common axial length, wherein each of the reamers in the third group includes a cutting portion having a uniform diameter extending axially between the distal and proximal ends of each cutting portion. Optionally, the distal reamer further comprises a fourth group and a fifth group, each of which comprises a plurality of reamers having different diameters and their respective common axial lengths, wherein each reamer of the fourth group includes a cutting portion having an axial length greater by the above-mentioned module increment value than the axial length of each cutting portion of the reamers of the third group, and each reamer of the fifth group includes a cutting portion having an axial length greater by the above-mentioned module increment value than the axial length of each cutting portion of the reamers of the fourth group.

[0017] Optionally, the diameter of the distal end of at least one cutting portion of the proximal reamers of the third group is equal to or approximately equal to the diameter of the proximal end of at least one cutting portion of the distal reamers of the fourth group and / or the distal reamers of the fifth group. Optionally, the diameter of the distal end of at least one cutting portion of the reamers of the proximal reamers of the third group is equal to or approximately equal to the diameter of the proximal end of at least one cutting portion of the reamers of the distal reamers of the third group.

[0018] Optionally, the axial length of each cutting portion of the reamer in the third group of proximal reamers is equal to or approximately equal to the axial length of the cutting portion of the reamer in the second group of proximal reamers, and the diameter of the cutting portion of the proximal reamers in the second group increases according to a tapered profile from the distal end to the proximal end of each cutting portion.

[0019] Optionally, each group of proximal reamers and each group of distal reamers may include reamers of different diameters within the ranges of 2-16, 4-14, 4-12, or 8-12. Optionally, the proximal end diameter of each cutting portion of the distal reamer may be within the ranges of 10-24 mm or 12-22 mm. Optionally, the distal end diameter of each cutting portion of the proximal reamer may be within the ranges of 10-24 mm or 12-22 mm. Optionally, the axial length of the reamers in the second group of proximal reamers may be within the ranges of 80-110 mm, 85-105 mm, or 90-100 mm. Optionally, the axial length of the reamers in the first group of distal reamers may be within the ranges of 125-155 mm, 130-150 mm, or 135-145 mm. Optionally, the axial length of the proximal reamer in the first group is within the range of 30-60 mm, 35-55 mm, or 40-50 mm. Optionally, the axial length of the distal reamer in the second group is within the range of 175-205 mm, 180-200 mm, or 185-195 mm. Optionally, the module increment is within the range of 20-75 mm, 25-70 mm, 30-65 mm, 35-65 mm, 40-60 mm, or 45-55 mm.

[0020] A further embodiment of the present concept provides a surgical device for preparing a bone site for receiving an implant, the surgical device comprising: a set of surgical reamers as described in any of the preceding claims; and a first implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the implant has a predetermined gauge value corresponding to a diameter at a predetermined axial position on the stem, the at least one reamer from at least one of the first group and the second group of distal reamers includes a cutting portion, the cutting portion having a gauge value corresponding to a diameter at a predetermined axial position on the cutting portion that is equal to the gauge value of the implant, thereby providing at least one gauge-matched distal reamer.

[0021] Optionally, a predetermined axial position on the cutting portion of the distal reamer is located at the proximal end of the cutting portion.

[0022] With the implant optionally positioned alongside a matched distal reamer, the cutting portion and stem aligned parallel or nearly parallel, and the distal tip of the stem coaxially aligned with the distal tip of the cutting portion of the distal reamer, the axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance.

[0023] The present invention provides at least one gauge-matched distal reamer, wherein the axial length of the second implant is greater than that of the first implant, and the second gauge-matched distal reamer has an axial length greater than that of the first gauge-matched distal reamer. The second implant optionally has a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the second implant has a predetermined gauge value corresponding to a diameter at a predetermined axial position on the stem, and at least one reamer from at least one of the distal reamers of the first group and the second group has a cutting portion, the cutting portion having a gauge value corresponding to a diameter at a predetermined axial position on the cutting portion equal to the gauge value of the implant, the axial length of the second implant is greater than that of the first implant, and the second gauge-matched distal reamer has an axial length greater than that of the first gauge-matched distal reamer.

[0024] Optionally, a predetermined axial position on the cutting portion of the distal reamer is located at the proximal end of the cutting portion.

[0025] Optionally, the implant is positioned alongside at least one gauge-matched distal reamer, with the cutting portion and stem aligned parallel or nearly parallel, and the distal tip of the stem coaxially aligned with the distal tip of the cutting portion of the distal reamer. The axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance.

[0026] According to a further aspect of the concept, a surgical method for preparing a surgical site and implanting an implant is provided, the method comprising selecting a distal reamer from the first and second groups of distal reamers of claim 1 that matches a predetermined gauge value of the implant to be implanted and a predetermined gauge value of one of the first and second groups of distal reamers; using the selected gauge-matched distal reamer to cut material from a distal position of the patient's surgical site; selecting a proximal reamer from one of the first and second groups of proximal reamers based on the axial length and / or gauge value of the implant to be implanted such that the combined axial length of the selected distal reamer and the cutting portion of the selected proximal reamer is shorter than the axial length of the implant measured between the distal tip of the implant stem and the center point of the implant head; using the selected proximal reamer to cut material from a proximal position of the surgical site; and implanting the implant at the surgical site within the patient.

[0027] Optionally, after the step of cutting material using the distal reamer, evaluating the state or condition of the material at the surgical site, and before the step of cutting material using the selected proximal reamer, selecting one of the proximal reamers of the first group, the second group, or the third group.

[0028] Optionally, if the proximal reamer is selected from group 1 or group 2, the implant to be implanted is a monolithic implant, or if the proximal reamer is selected from the proximal reamers of group 3, the implant is a modular implant having a proximal body (neck for attaching the head) removably attachable to the distal stem, and the selected distal reamer is configured for sequential use to cut material at the surgical site using either the proximal reamers of the first and second groups or the proximal reamers of the third group.

[0029] According to a further aspect of the present concept, a surgical reamer set is provided, the surgical reamer set including a plurality of distal reamers each having a cutting portion extending between a distal tip and a proximal end, the distal reamers including at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length greater than the first axial length, and a plurality of proximal reamers each having a cutting portion extending between a distal end and a proximal end, the proximal reamers including at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length greater than the first axial length of the proximal reamers.

[0030] Preferably, the distal reamers and the proximal reamers are configured such that the proximal ends of the first group of distal reamers can be positioned adjacent to the distal ends of the first and second groups of proximal reamers, and the distal ends of the second group of proximal reamers can be positioned adjacent to the proximal ends of the first and second groups of distal reamers.

[0031] Preferably, the combined axial lengths of the cutting portions of the first group of proximal reamers and the first group of distal reamers, the second group of proximal reamers and the first group of distal reamers, and the second group of proximal reamers and the second group of distal reamers differ from each other by at least one of the above module increment values.

[0032] In a further embodiment, the Disclosure provides a set of surgical instruments comprising two or more first-type surgical instruments, each comprising a proximal end and a distal end, and / or one or more cutting elements provided by a distal portion between the proximal and distal ends, and / or a position having a position diameter which may be intermediate between the proximal and distal ends, and at least two of the first-type surgical instruments further comprising having proximal and distal ends of different lengths, and / or having position diameters which have the same diameter, and / or having position diameters which are at the same distance from each other to the proximal end of the first-type surgical instrument.

[0033] Optionally, three and / or four and / or all of the first type surgical instruments in this set may have different lengths between their proximal and distal ends. Optionally, three and / or four and / or all of the first type surgical instruments in this set may have positions (predetermined axial positions) with the same diameter as each other. Optionally, three and / or four and / or all of the first type surgical instruments in this set may have positions with positional diameters that are the same distance from each other to the proximal end of the first type surgical instrument.

[0034] Optionally, the first type of surgical instrument may be a reamer. The first type of surgical instrument may be a distal reamer. The first type of surgical instrument may have, for example, a tapered portion at its distal end. The tapered portion may be fully tapered. One or more cutting elements may be provided within the tapered portion. One or more cutting elements may extend distally and / or radially, for example, inclined. A mounting element may be provided at the proximal end. The mounting element may connect the first type of surgical instrument to a drive device during use. The mounting element may interact with and, for example, accept a second type of surgical tool, such as a different type of reamer, during use. The mounting element may be a shaft or a stem. The mounting element may have a mounting element diameter. The mounting diameter may be smaller than the position diameter and / or smaller than the internal bore diameter of the second type of surgical tool.

[0035] Optionally, one or more or all of the instruments of the first type may have a mounting element having the same length from proximal to distal. The distal end may be provided with an increased tapered portion. Optionally, this position may be, for example, a cross-sectional position through the surgical instrument perpendicular to the axis of the surgical instrument. The position may be a gauge position. The position diameter may be the maximum diameter at that position. The position diameter may be the minimum diameter at that position. The position diameter may be the average diameter around the position. Optionally, the distal portion providing one or more cutting elements may extend distally to the position for one or more or all of the instruments of the first type. The distal portion providing one or more cutting elements may extend proximal to the position for at least one or two of the instruments of the first type. The distal portion providing one or more cutting elements may extend distally and proximal to the position for at least one or two of the instruments of the first type. The distal portion providing one or more cutting elements does not have to extend proximal to the above position for at least one or two of the first type of cutting elements. The set of the first type of surgical instruments may be provided with one or more types of surgical implants. When the set of the first type of surgical instruments is provided with one or more types of surgical implants, positions having the same diameter as each other may be at the same distance from the head portion of the surgical implant, e.g., the head center. This type of surgical implant may be a modular surgical implant.

[0036] If, optionally, a set of the first type of surgical instruments is provided with one or more types of surgical implants, positions having the same diameter as each other may be at the same distance from the proximal end of the surgical implant, e.g., the head center, as the starting point of the flute on the surgical implant. This type of surgical implant may be a single or integral surgical implant.

[0037] A set of the first type of surgical instruments may be provided together with one or more sets of the second type of surgical instruments.

[0038] Further aspects of this disclosure may include any of the features, options, or possibilities described elsewhere in this specification, including other aspects.

[0039] In a further embodiment, the Disclosure provides a set of surgical instruments comprising two or more first-type surgical instruments, each of which comprises one or more cutting elements provided by a proximal end and a distal end, and / or a cutting portion provided between the proximal end and the distal end, which may have a proximal limit, and further comprising at least two of the first-type surgical instruments having different lengths between the proximal and distal ends, and / or the proximal limits of the cutting portions being at the same distance from each other with respect to the proximal end of the first-type surgical instrument.

[0040] Optionally, the cutting portion may have a distal limit at the distal end of the surgical instrument. Optionally, at least two of the first type of surgical instruments may further include having proximal and distal ends of different lengths, and having positions with the same diameter and positions with the same positional diameter at the same distance from the proximal end of the first type of surgical instrument. Optionally, two or more of the first type of surgical instruments may have a first same distance from the proximal limit of the cutting portion. Two or more of the first type of surgical instruments may have a second same distance from the proximal limit of the cutting portion. The first same distance may be smaller than the second same distance. If two or more of the first type of surgical instruments have the above position, the first same distance may be proximal to that position. If two or more of the first type of surgical instruments have the above position, the second same distance may coincide with that position.

[0041] Optionally, three and / or four and / or all of the first type surgical instruments in this set may have different lengths between their proximal and distal ends. Three and / or four and / or all of the first type surgical instruments in this set may have positions having positional diameters that are the same diameter as each other. Optionally, three and / or four and / or all of the first type surgical instruments in this set may have positions having positional diameters that are the same distance from each other to the proximal end of the first type surgical instrument.

[0042] Optionally, two or more of the surgical instruments of the second type may have the same first distance from the proximal limit of the cutting portion to the distal limit of the cutting portion. Two or more of the surgical instruments of the first type may have the same second distance from the proximal limit of the cutting portion to the distal limit of the cutting portion. The first same distance may be smaller than the second same distance.

[0043] In a further aspect, the present disclosure provides a surgical method which provides a set of first type surgical instruments according to one aspect of the present invention described herein and claimed herein, and / or selects first surgical instruments of first type from the set of instruments, and / or cuts material from a patient's surgical site using first surgical instruments, and / or provides first type surgical implants and second type surgical implants, and / or provides two sets of second type surgical instruments, wherein the first set of the two sets is related to one or more physical properties of the surgical instruments compared to the second set of the two sets. This may include providing and / or evaluating the patient for the use of either a first type of surgical implant or a second type of surgical implant, and / or, if a first type of surgical implant is used, also selecting to use a first set of second type of surgical instruments, and / or, if a second type of surgical implant is used, also selecting to use a second set of second type of surgical instruments, and / or using at least one of the second set of surgical instruments on the patient, and / or implanting the selected surgical implant into the patient.

[0044] The first type of surgical implant may be a non-customizable implant. The first type of surgical implant may be a single or integral implant.

[0045] Optionally, the second type of surgical implant may be a customizable implant. The second type of surgical implant may be a modular implant. The second type of implant may include a separate distal stem portion, as well as separate proximal stem and head portions. Multiple distal stem portions and / or proximal stem and head portions with different characteristics may be provided, for example, for selection from there.

[0046] Optionally, the first type of surgical implant and / or the second type of surgical implant may differ in terms of profile and / or proximal-to-distal length, and / or lateral range of the head section and / or inclination of the head section and / or profile and / or flute of the head section (including their profiles and / or start and / or end positions and / or inclination), and / or formation of the surgical implant from a single element or from two or more interconnected elements (including modular implants in which the stem and head are connected and selected from a wide variety of different stems and / or heads).

[0047] The first set of the second type of surgical instrument may be a reamer. The first set of the second type of surgical instrument may be a proximal reamer. The first set of the second type of surgical instrument may have, for example, a tapered portion at the distal end. The tapered portion may be a partial taper. The first set of the second type of surgical instrument may have a conical portion. Optionally, the first set of the second type of instrument may include one or more cutting elements that can be provided on the tapered portion or the conical portion. The one or more cutting elements may extend distally and / or radially, for example, inclined.

[0048] Optionally, the first set of the second type of instrument may include a proximal end to which a mounting element may be provided. The mounting element may connect the second type of surgical instrument to a drive device when in use. The mounting element may be a shaft or a stem. The mounting element may have a mounting element diameter. The mounting diameter may be smaller than the position diameter. Optionally, one or more or all of the first set of the second type of instrument may have a mounting element having the same length from the proximal to the distal direction. Optionally, the first set of the second type of instrument may be provided with, for example, a flat distal end perpendicular to the axis of the instrument.

[0049] The second set of the second type of surgical instruments may be a reamer. The second set of the second type of surgical instruments may be a proximal reamer. The second set of the second type of surgical instruments may have, for example, a non-tapered portion at the distal end. The non-tapered portion may be a cylindrical portion.

[0050] A second set of the second type of instrument may include one or more cutting elements that may be provided on the cylindrical portion. The one or more cutting elements may extend distally and / or radially, for example, inclined. Optionally, a second set of the second type of instrument may include a proximal end on which a mounting element may be provided. The mounting element may connect the second type of surgical instrument to a drive device when in use. The mounting element may be a shaft or a stem. The mounting element may have a mounting element diameter. The mounting diameter may be smaller than the position diameter.

[0051] Optionally, one or all of the second set of the second type of device may have attachment elements having the same length from proximal to distal. Optionally, the second set of the second type of device may have, for example, a flat distal end perpendicular to the axis of the device. Optionally, the second type of device may have a proximal-to-distal length that is shorter than the proximal-to-position length of the first type of device.

[0052] Optionally, a second type of instrument set may include two or more instruments having the same length from the first proximal to distal end of the cutting element as the first set and / or the second set. A second type of instrument set may include two or more instruments having the same length from the second proximal to distal end of the cutting element as the first set and / or the second set. The length from the first proximal to distal end may be shorter than the length from the second proximal to distal end.

[0053] In a further aspect, the present disclosure provides a surgical method which provides a set of first type surgical instruments according to one aspect of the present invention described herein and claimed herein, and / or selects first surgical instruments of first type from the set of instruments, and / or cuts material from a patient's surgical site using first surgical instruments, and / or provides first type surgical implants and second type surgical implants, and / or provides two sets of second type surgical instruments, wherein the first set of the two sets is related to one or more physical properties of the surgical instruments compared to the second set of the two sets. This may include providing and / or evaluating the patient for the use of either a first type of surgical implant or a second type of surgical implant, and / or, if a first type of surgical implant is used, also selecting to use a first set of second type of surgical instruments, and / or, if a second type of surgical implant is used, also selecting to use a second set of second type of surgical instruments, and / or using at least one of the second set of surgical instruments on the patient, and / or implanting the selected surgical implant into the patient.

[0054] Optionally, the first and / or second type surgical implants may be customizable implants. The first and / or second type surgical implants may be modular implants. The first and / or second type implants may include a separate distal stem portion, as well as separate proximal stem and head portions. Multiple distal stem portions and / or proximal stem and head portions with different characteristics may be provided, for example, for selection from there. [Brief explanation of the drawing]

[0055] Below, for illustrative purposes only, a specific implementation of this subject will be described with reference to the attached diagrams. [Figure 1A] This is a plan view of a tray for a distal reamer, which has cutting sections of different diameters and a first common length, in a specific mounting configuration. [Figure 1B] This is a plan view of a distal reamer tray having a second common length and separate cutting sections of different diameters, in a specific implementation configuration for preparing the bone site for receiving an integrated implant. [Figure 1C] This is a plan view of a distal reamer tray having a specific implementation configuration for preparing the bone site to receive an integrated implant, with separate cutting sections of different diameters and a third common length. [Figure 2A] This is a plan view of a proximal reamer having a specific implementation configuration for preparing a bone site to receive an integrated implant, with separate cutting sections of different diameters and a first common length. [Figure 2B] This is a plan view of a proximal reamer having separate cutting sections of different diameters and a second common length, in a specific implementation configuration for preparing the bone site to receive an integrated implant. [Figure 2C] This is a plan view of a proximal reamer having cutting portions of different diameters and a first common length, in a specific implementation configuration for receiving a modular implant formed from multiple distinct components. [Figure 3A] This is a side view of the distal reamer of the first set, corresponding to Figure 1A. [Figure 3B] This is a side view of the proximal reamer of the set corresponding to Figure 2B, which has a relatively short tapered cutting section. [Figure 3C] This is a side view of the proximal reamer of the set corresponding to Figure 2A, which has a tapered cutting section with a relatively long cutting length. [Figure 3D] This is a side view of the proximal reamer of the set corresponding to Figure 2C, which has a relatively long cutting length and a conical cutting section. [Figure 4] This is a schematic diagram of hip arthroplasty, in which an integrated implant is inserted into a pre-prepared surgical site in the patient's bone. [Figure 5] This is a schematic diagram of hip arthroplasty, in which modular implants are inserted into pre-prepared surgical sites in the patient's bone. [Figure 6] This is a schematic diagram of the initial bone preparation stage, including distal reaming of the femoral canal. [Figure 7] This is a schematic diagram of a further step in hip arthroplasty, including the attachment of a proximal reamer to the proximal end of a distal reamer. [Figure 8] Figure 7 is a schematic diagram of the assembled reaming device, in which the proximal reamer is attached proximal to the distal reamer and inserted into the femoral canal. [Figure 9A] This is a front view of a one-piece integrated hip joint implant. [Figure 9B] Figure 9A is a side view of the implant. [Figure 10] A schematic diagram shows an axially assembled assembly of proximal and distal reamers having different axial length combinations, suitable for preparing a bone site to receive an artificial prosthesis of a desired axial length to match the patient's anatomical profile. [Figure 11] A schematic diagram of interchangeable components of this concept is shown, enabling the preparation of the surgical site for receiving prosthetic devices using proximal and distal reamers, according to a specific implementation of this concept. [Modes for carrying out the invention]

[0056] This concept provides a fully modular and interchangeable set of surgical site preparation instruments, in particular a collection of distal and proximal reamers specifically configured for preparing bone sites suitable for arthroplasty. Additionally, the instrument set of the present invention enables convenient and efficient "in-procedure" exchange between intended implantation of integrated (one-piece) implants and modular implants through common distal reaming site preparation. In particular, the instrument set of the present invention comprises distal reamers in various length and gauge (diameter) configurations suitable for both implantation of one-piece and modular prostheses. The instrument set of the present invention comprises at least a first type of proximal reamer and a second type of proximal reamer, each specifically configured for one-piece or modular prostheses.

[0057] Referring to Figure 1A, the instrument tray 10 contains a set of distal reamers 13a. Specifically, the tray 10 contains 11 reamers 13a of the same axial length, but each reamer 13a has a different diameter. Each reamer 13a includes a cutting portion 60 extending between the distal tip 15 and the proximal end 14. The cutting portion 60 has a diameter that decreases between the end 14 and the tip 15 according to a tapered profile. Each reamer 13a includes a cutting flute 17 that extends spirally across the cutting portion 60 between the tip 15 and the end 14. The shaft 16 protrudes proximal from the proximal end 14 and is adapted for connection to a drive tool (not shown). According to a particular implementation, the reamers 13a in the set 10 vary in maximum diameter from 12 to 22 mm. Each reamer 13a has a length of 140 mm.

[0058] Referring to Figure 1B, the second instrument tray 11 contains multiple (11) proximal reamers 13b, each having the same configuration, features, and function as the reamer 13a in Figure 1A. However, the reamers 13b have a longer axial length of 190 mm compared to the reamers 13a. The reamers 13b have a maximum diameter of 12–22 mm. Furthermore, the instrument tray 12 according to Figure 1C contains multiple (11) distal reamers 13c, each having a cutting portion 60 and the same features and function as the reamers 13a described with reference to Figures 1A and 1B. However, the axial length of each cutting portion 60 of the reamers 13c is shorter than that of the reamers 13a and 13b, at 120 mm. Thus, different sets of distal reamers 10, 11, and 12 can be used to prepare surgical sites for receiving implants of different lengths.

[0059] A set of proximal reamers 18 is provided on an additional tray, which contains 13 reamers 25a. Each of the proximal reamers 25a includes a cutting portion 22 extending between a distal end 23 and a proximal end 24. The shaft 21 protrudes proximal from the proximal end 24 and is adapted to connect to the same drive tool (not shown) that can be attached to the distal reamers 13a-13c. Each of the reamers 25a, in particular each cutting portion 22, has the same axial length but differs in maximum diameter within the range of 12-22 mm. Figure 2B shows a further set (11) 19 of proximal reamers mounted in an additional tray. The proximal reamers 25b have the same features and functions as those described with reference to Figure 2A, in particular including the cutting portion 22, the shaft 21, and the respective cutting portion ends / distal ends 23, 24. Both sets of proximal reamers 25a and 25b feature tapered cutting portions 22 such that the diameter decreases between the proximal end 24 and the distal end 23. A range of various diameters and the number of distal and proximal reamers provided offer overlap between the respective diameters of the proximal ends 24 of the proximal reamers 25a and 25b and the diameters of the proximal ends 14 of the distal reamers 13a–13c. This configuration allows surgeons to select a suitable proximal reamer from sets 18 and 19 with desired maximum diameters and axial lengths for collaborative use with one or more selected distal reamers from sets 10, 11, and 12 at the surgical site. Through their respective tapered diameter profiles, sets 10, 11, and 12, as well as 18 and 19, of distal and proximal reamers are adapted to prepare the surgical site for receiving integrated implants.

[0060] Referring to Figure 2C, a further set 20 of proximal reamers is provided in an additional tray. Specifically, set 20 includes 13 proximal reamers 26, each having a cutting portion 22 defined by terminal ends 23, 24 that share most of the features and functions of reamer 25a in Figure 2A. However, according to the further set 20, the reamers 26, in particular the cutting portion 22, have a uniform diameter between the proximal end 24 and the distal end 23. In particular, the cutting portion 22 of the reamer 26 is substantially conical. However, all reamers 25a, 25b, and 25c in their respective cutting portions 22 include a cutting flute similar to the flute 17 of the distal reamers 13a-13c. Therefore, the proximal reamer set 20 is configured for surgical preparation for receiving a modular prosthesis, in which the stem is separate from and attachable to the neck, which has a head mount / trunnion for mounting a femoral head component that fits into the acetabular cup. The proximal reamer sets 20, 18, and 19 are adapted to work in conjunction with one or a combination thereof of the distal reamers 13a, 13b, and 13c to cut and be coaxially mounted. Thus, the diameter of each cutting portion 22 at the distal end 23 corresponds to at least some of the respective diameters of the proximal ends 14 of the cutting portions 60 of the reamers 13a-13c. Advantageously, if the surgeon assesses the condition of the surgical site, particularly the bone and / or tissue, during the surgical procedure, the surgical procedure may be changed from the intended implantation of a one-piece implant to a modular implant. Such a situation may be necessary when it is desirable to preserve tissue and / or bone to a greater extent and minimize cutting. This change to modular implants during surgery offers surgeons greater adaptability during complex and unpredictable procedures. As is understood, surgeons prioritize preserving remaining bone and minimizing operative time to reduce blood loss and exposure to anesthetic gases. One-piece implants are typically preferred for enhanced bone contact and shorter operative times. However, modular implants are beneficial for maximizing bone preservation in femurs with more severe defects.Since such decisions and evaluations can be made during surgery, the instrument set of the present invention enables surgeons to optimize the aforementioned considerations for the patient's health and the best possible outcome.

[0061] Figures 3A to 3D are side views of the distal reamer 13 and the proximal reamers 25b, 25a, and 26. Referring to Figure 3A, the shaft 16 has one or more feature portions 28 to facilitate attachment to a drive tool (not shown). Similarly, each of the proximal reamers 25b, 25a, and 26 has a corresponding feature portion 28 for direct or indirect connection to a drive tool. Each of the proximal reamers 25b, 25a, and 26 includes an internal hole 41 sized to receive the shaft 16. Thus, each of the proximal reamers 25b, 25a, and 26 may be coaxially mounted at the proximal end of the distal reamer 13 to form an axial stack or assembly. The proximal reamers assembled with the distal reamer can then be driven via a drive tool. Additionally, the proximal reamers 25b, 25a, and 26 of the present invention may be used separately from the distal reamer 13 as needed by the surgeon. The cutting flutes 17, 27 extend along the entire axial length of each respective cutting portion 60, 22, and are preferably helical between the axial ends. However, as can be understood, further embodiments may include different configurations of cutting elements, including blades, ribs, grooves, and the like.

[0062] Referring to Figure 4, the femur 29 may be prepared by sequentially reaming the femoral canal 29a using a distal reamer 13 and then a proximal reamer 25a, 25b, or 26 to prepare an implant site cavity 30 adapted to receive an implant 31. The implant 31 includes a stem 32, a neck 33, and a trunnion (head mount) 34 for mounting the head (as understood). Referring to Figure 5, the prepared cavity 30 may alternatively be adapted via the use of a proximal reamer 26 to receive a modular implant 35. The implant 35 also includes a stem 32 that can be inserted into the pre-prepared femoral canal 29a, and further includes a modular shoulder portion 37 that can be mounted on a spigutta 36. The neck 38 extends from the shoulder portion 37 and terminates at a head trunnion 39.

[0063] Referring to Figure 6, the initial stage of the surgical procedure to prepare the femur 29 to receive either implant 31 or 35 includes initial distal reaming using multiple distal reamers appropriately selected from the appropriate set 10, 11, or 12. Specifically, the selected distal reamers have axial length and diameter that match the axial length, diameter, and specifically the gauge of implant 31 or 35. Typically, the initial distal reaming stage may use 3 to 6 distal reamers 13 from any of the sets 10, 11, or 12, starting with reamers of smaller diameters and ending with reamers of the maximum diameter in a particular set / tray that match the gauge of implant 31 or 35. A drive mount 40 is attachable to the distal reamer shaft 16 for connection with a drive tool (not shown).

[0064] Referring to Figure 7, further steps of the procedure include proximal reaming via selected proximal reamers from set 18, 19, or 20. If a decision is made to proceed with the integrated implant 31, three to six proximal reamers of different diameters (e.g., three to six) may be selected from one of sets 18 or 19 and used to work together to remove bone from the femoral canal 29a. In particular, the proximal reamer 25b is insertable into a hole 41 extending axially within the proximal reamer 25 and is fitted onto an axial coupling 40b (an extension of the shaft 16) that is receptive. The assembled combination of proximal and distal reamers is shown in Figure 8. If a decision is made to proceed with the modular implant 35, a proximal reamer 26 of the appropriate diameter may be used instead of reamers 25a and 25b.

[0065] As shown, during the procedure, the surgeon selects a first distal reamer from a set of distal reamers, uses the first distal reamer to expand the channel, then withdraws the first distal reamer, and then repeats this process with a second larger diameter reamer. The surgeon may use reamers of further increasing diameter until the desired channel diameter and profile is achieved. Typically, the surgeon knows that the desired bone preparation point has been reached by a "cortical chatter." During the distal reaming stage, the surgeon can generally establish whether the prepared seating position for the stem of the surgical implant is predictable; that is, once the actual implant is inserted, it will seat in the desired position within the femur, and therefore relative to the articular position. The stem will stabilize axially during subsequent stages and use. In such cases, the surgeon proceeds with the planned use of the first type of surgical implant. A one-piece surgical implant may be used as a first type of surgical implant, in which case the entire stem portion is defined by a single element.

[0066] As shown, in some situations, in patients with poor bone quality, the bone may not provide sufficient engagement or support to the stem and implant, and the surgeon may determine that an alternative type of implant needs to be used. Returning to the procedure, if the first type of surgical implant is used (one-piece), the procedure then involves selecting a proximal reamer. Typically, the first diameter of the proximal reamer is selected. The reamer blade is located at the distal end, and the mounting position is located at the proximal end. As shown in Figure 7, the proximal reamer is mounted on a drive device and then inserted onto the proximal end of the last distal reamer used. The proximal end of the last distal reamer is received within the internal bore of the proximal reamer. As seen in Figure 8, the position of the proximal reamer is controlled distally by the proximal end of the distal reamer contacting the proximal inner surface of the hole in the proximal reamer. The proximal reamer is then used to remove further material from the proximal portion of the femoral channel. Here again, the process can be repeated while increasing the outer diameter of the proximal reamer from within the set in order to generally increase the proximal channel diameter or profile.

[0067] Once the site is prepared, the first type of surgical implant can be inserted into its final position. If, during or at the end of the distal reaming stage, the surgeon determines that the site in the patient is not sufficiently stable for the first type of surgical implant, the possibility of switching to a different type applies. However, the sets of reamers provided for different types of implants differ considerably in length, profile along their length, and general morphology. Therefore, the surgeon may face the need to open and use more reamer sets, particularly distal reamers, and / or perform further preparatory operations in the femur for different types of implants. These steps potentially add to surgical time, cost, and complexity. In this disclosure, selective design across different sizes of different implant types, and particularly careful design of reamer sets, means that a given reamer set is more versatile and has better interchangeability between instrument types.

[0068] Referring to Figures 9A and 9B, each of the implants 31 and 35 includes a predetermined gauge value corresponding to its diameter at an axial length position 42. The axial length position 42 is preset axially by a separation distance D from the central region / point of the head trunnion 34. Different sizes and dimensioned implants 31 are, exemplary, superimposed such that the first size 43 includes the same axial position 42 of the gauge position for implants 31 of longer length 44 and further sizes 45 of even longer length. The set of instruments of the present invention is particularly adapted to provide a modular set of components including distal and proximal reamers, the distal and proximal components being interchangeable to fit different sizes 43, 44, and 45, according to a predetermined separation distance D and axial gauge position 42.

[0069] The modular configuration of the instrument of the present invention is shown in Figure 10. In particular, each combination of distal reamer and proximal reamer of this concept includes a predetermined gauge value G and is axially co-aligned with the same head center point separation distance D as defined for the implant 31 with reference to Figures 9A and 9B. As shown, the gauge positions G of the distal reamers 13a, 13b, and 13d (also fitted with the proximal reamer 25a) are co-aligned at the proximal end 14 of their respective cutting portions 60. The combination of the proximal reamer 25b (having a shorter axial length than reamer 25a) and the distal reamer 13a includes a gauge position G at approximately the midpoint along the cutting portion 60. Furthermore, with further configurations and pairings of the distal reamer 13c and the proximal reamer 25b, the gauge position G is located near the distal tip 15.

[0070] The proximal ends 24 of all assembled proximal reamers 25a, 25b (when paired with distal reamers 13a, 13b, 13c, 13d of different sizes) are all coaxially aligned with respect to the head center position at a predetermined separation distance A, and separation distance A partially defines the separation distance D of the gauge position. In this configuration, distance A is 50 mm depending on the specific configuration. Separation distance B corresponds to the axial length of each cutting portion 22 of the proximal reamer 25, and separation distance C corresponds to the axial length of the cutting portion 60 of the distal reamer 13b. Referring to Figure 10, the axial length H is the separation distance between the proximal end 14 and the distal tip 15 of the cutting portion of the distal reamer 13c, the axial length K is the separation distance between the proximal end 24 and the distal end 23 of the cutting portion of the proximal reamer 13c, the axial length I is the separation distance between the proximal end 14 and the distal tip 15 of the cutting portion of the distal reamer 13a, and the axial length J is the separation distance between the proximal end 14 and the distal tip 15 of the cutting portion of the distal reamer 13d.

[0071] The modular structure and interchangeability and compatibility of the reamers / implants of the present invention are achieved by a common / uniform increment in the respective axial lengths of the cutting portions of the various proximal and / or distal reamers described herein. Specifically, referring further to Figure 10, the difference between all the respective lengths, K and B, H and I, C and J, is equal. In other words, the increase in the sum of the lengths of the combined cutting portions of reamers 25a and 13d relative to the lengths of reamers 25a and 13b is equal to the increase in the sum of the combined cutting portions of reamers 25a and 13b relative to the lengths of reamers 25a and 13a, which is equal to the increase in the sum of the lengths of the combined cutting portions of reamers 25a and 13a relative to the lengths of reamers 25b and 13a, which is equal to the increase in the sum of the lengths of the combined cutting portions of reamers 25b and 13a relative to the lengths of reamers 25b and 13c.

[0072] As the implant length increases, the reamer length needs to increase distally to the gauge position. However, since the tapered portion of the distal reamer extends proximal to the gauge position, a common second type (proximal reamer) can be used for the first implant length, and a common second type (proximal reamer) can also be used for a second different implant length, thereby reducing the number of distal reamers required.

[0073] As described, the set of surgical instruments of the present invention provides intraoperative changes between different implant types and / or sizes through a modular configuration of the axial length and diameter of each cutting portion, in addition to the various diameters within each set, thereby preserving bone and minimizing surgical time. In addition, the surgical instruments of the present invention, set through the various length and diameter profiles of individual sets of reaming instruments, minimize the total number of cutting instruments forming the kit by utilizing a common cutter suitable for preparing the surgical site regardless of the implant type. As shown, this is provided in part by a common gauge position G in each cutting portion of the cutting instrument, corresponding to the gauge position of the implant. This is achieved by the modular and / or common / uniform size difference between the various distal reamers and / or proximal reamers. That is, the sizes of the various sets of distal reamers and / or proximal reamers differ from each other by the same / common qualitative modular amount. This provides reamers with cutting portions of different lengths, while each reamer in each / all sets(s) includes the same axial position G corresponding to the gauge position. This interchangeability and modularity can be best illustrated in Figure 10 by pairing the proximal reamer 25a with each of the different distal reamers 13a and 13b. Although not shown, if a decision is made to change from a one-piece implant (Figure 4) to a modular implant (Figure 5), the proximal reamer 26 is used in place of reamer 25a, for example, in pairings with distal reamers 13a, 13b, or 13d.

[0074] The interchangeability under this concept is further schematically shown in Figure 11. In particular, the set of instruments of the present invention includes a core set 50 of integral reamers, which includes a subset containing a short / standard proximal reamer 51 and a long / extra-long (XL) proximal reamer 52. The short / standard proximal reamer 51 (corresponding to reamer set 19) may be used in cooperation with a short distal reamer 53 or a standard / long distal reamer 54 (corresponding to distal reamer sets 12, 10, and 11, respectively). The long / XL proximal reamer 52 is configured to be used in cooperation with a further set of standard / long distal reamers 54 and an XL distal reamer 55.

[0075] These instruments further include a modular core of reamer 56, which in particular includes a subset of modular proximal reamers 57 (corresponding to proximal reamer set 20). As shown, the modular proximal reamer 57 and the integral proximal reamers 51, 52 differ in that the cutting portion is cylindrical and truncated cone, respectively. The modular proximal reamer 57 is compatible with interchangeability and use with a group of distal reamers of different sizes, including the standard / long distal reamer 54, XL distal reamer 55, XXL distal reamer 58, and XXXL distal reamer 59.

[0076] At least the various reamers of the first and second types herein are provided in a series of different lengths considered from proximal to distal. For example, for each of the different sets of reamers, there are three different lengths: a standard reamer, a long reamer, and an extra-long reamer. The number of different lengths may be less than or more than three, and in some other embodiments described, four different lengths are provided. These different length configurations may be provided for both distal reamer types and proximal reamer types. Thus, there may be a first type with a standard length, a first type with a long length, and a first type with an extra-long length. Also, there may be a second type with the same standard length, a second type with the same long length, and a second type with the same extra-long length.

[0077] As shown, the gauge position is defined for each of the different types and lengths, which are standard, long, extra-long, XXL, and XXXL. At the gauge position, the diameter of the surgical implant is the same in each case. In this disclosure, for each of the different types of surgical implants, the gauge position is located at the same position. For each of the different lengths, which are standard, long, extra-long, XXL, and XXXL, the gauge position is also located at the same position. The gauge position may be defined so that it is in the same position when aligned as shown in Figures 9A, 9B, and 10. For example, the gauge position may be in the same position by being located at a given distance D from the center of the head trunnion 34, i.e., distally. Between the gauge position and the proximal end of the stem section, each of the different lengths, such as standard, long, and extra-long, may have a corresponding proximal stem section in terms of diameter and / or other profile characteristics across the different lengths. Between the gauge position and the proximal end of the stem section, each of the different types of surgical implants may have corresponding proximal stem sections in terms of diameter and / or other profile characteristics, spanning different lengths such as standard, long, and extra-long.

[0078] At the distal end of the gauge position, different lengths may have different diameters and / or other profile characteristics. For example, each may have a tapered portion that increases towards the distal end, and / or each may have distal stem sections of different lengths. At the distal end of the gauge position, two or more of the different lengths may have a common profile with respect to the initial section. At the distal end of the gauge position, each of the different lengths may have the same diameter and / or other profile characteristics for that length. Similar to the differences in profile and / or proximal-to-distal length described above, other differences may exist between types of surgical implants and / or between different sets of reamers. For example, with respect to implants, there may be differences in the lateral range of the head section and / or the inclination of the head section and / or the profile and / or flute of the head section (including those profiles and / or start and / or end positions and / or inclination), and / or differences in the formation of surgical implants from a single element or from two or more interconnected elements (including modular implants in which the stem and head are connected and selected from a wide variety of different stems and / or heads).

[0079] As described herein, the gauge position is, in each case, at the same fixed distance from the proximal end of the implant, from the center of the head section. It is also at a constant distance from the proximal end of the mounting element of the second type of surgical instrument shown in the illustration. This is a slightly reduced distance compared to the proximal end of the head section, a reduction of approximately 10-15 mm. The gauge position is also at a constant distance from the proximal end of the mounting element of the first type of surgical instrument (covered by and received within the internal bore of the second type). As shown, since the gauge position is constant for all surgical instruments and implants as described herein, the same distal reamer can be used for distal reaming of any implant type.

[0080] Importantly, the taper and cutting area (tapered or cylindrical) of the proximal reamer are maximized by minimizing the proximal cylinder length, which may be 50 mm ± 10%. The proximal cylinder length is the same throughout the length used. Thus, this disclosure provides surgeons with the possibility of completely converting to a second type of surgical implant after the distal reaming stage without requiring further distal reaming or other preparatory steps.

[0081] Regarding the set of reamers required overall, the reamer design allows the surgeon to select the appropriate size of implant needed to fit the patient's femur, for example, in the preoperative planning. During use, regardless of which of the different types of surgical implants will be used, the first reamer tray may be opened and the distal reamers from it may be used. The surgeon decides midway through the overall procedure whether to continue the planned use of the first one-piece type surgical implant or to switch to the second / modular type. If the first type is still used, only the second tray of proximal reamers will be opened and used, and the remaining trays will remain unopened and unused. If a change to the second / modular type is made, only the tray 20 with a different type of proximal reamer 26 will be opened and used, and the second trays will remain unopened and unused.

[0082] An example of how reamers can overlap in their roles in a more partial sense and still have similar advantages can be seen in Figure 11. Each block in Figure 11 may represent a tray. For example, both the St / L distal reamer tray and the XL distal reamer tray can be used during the distal reaming stage, further allowing surgeons to easily choose between using a one-piece core tray as the first intended type of implant used, or changing to a modular core tray when a second type of implant is required. When a one-piece core tray is used, the L / XL proximal reamer tray is used. When a change to a modular core tray is made, the modular proximal reamer tray is used.

[0083] The overlap in reamer configurations is partial, as the short distal reamer tray leads to the use of a core tray for the integrated system (further reaming may be an option to transition to the use of a core tray for the modular system), but still, to achieve the proximal reaming stage, only the use of the Sh / St proximal reamer tray is required. Similarly, the XXL distal reamer tray leads to the use of a core tray for the modular system, but if the XXL distal reamer tray or XXXL distal reamer tray is used for the distal reaming stage, then the modular proximal reamer tray is all that is needed.

[0084] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to the extent of the subject matter described herein.

[0085] When a range of values ​​is provided, for example, a concentration range, a percentage range, or a ratio range, each value within that range (up to one-tenth of the lower limit unit between the upper and lower limits of that range and any other range described, i.e., each value within that described range) is understood to be included within the described subject. The upper and lower limits of these smaller ranges may also be independently included within their smaller ranges, and such embodiments shall also be included within the scope of the described subject, such that any limit values ​​may be specifically excluded from the described range. If the described range includes one or both of the limit values, the range excluding one or both of these included limit values ​​shall also be included within the described subject.

[0086] It should be understood that the terms “a” and “an” as used above and elsewhere in this specification refer to “one or more” of the enumerated components. Those skilled in the art will see that the use of the singular form includes the plural form unless otherwise specified. Therefore, the terms “a,” “an,” and “at least one” are used interchangeably in this application.

[0087] Unless otherwise stated, all figures used in this specification and the claims to describe the properties of components, such as quantity, size, weight, and reaction conditions, are understood in all cases to be modified by the term "approximately." Therefore, unless otherwise indicated, the numerical parameters described in the following specification and the attached claims are approximations that may vary depending on the desired properties to be obtained with respect to this subject matter. At the very least, no attempt should be made to limit the application of the doctrine of equivalents to the scope of the claims, and each numerical parameter should be interpreted at least by considering the reported number of significant figures and applying the usual rounding method.

[0088] Throughout this application, the expression “comprising” is used in the description of various embodiments, but those skilled in the art will understand that in some examples the embodiments could be described using the expression “consisting essentially of” or “consisting of.”

[0089] Although this subject matter is written as such, it will be apparent that this subject matter may be modified or altered in many ways. Such modifications and alterations will not be considered to deviate from the spirit and scope of this subject matter, and all such modifications and alterations are intended to be included in the following claims.

[0090] [Implementation Method] (1) A set of surgical reamers, A plurality of distal reamers, each having a cutting portion extending between a distal tip and a proximal tip, wherein the plurality of distal reamers include at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length that is greater by a module increment than the first axial length, A plurality of proximal reamers, each having a cutting portion extending between a distal end and a proximal end, wherein the plurality of proximal reamers include at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length that is greater than the first axial length of the proximal reamer by the module increment value, A set of surgical reamers, wherein the distal reamers and proximal reamers are configured such that the combined axial lengths of the cutting portions of the proximal reamers of the first group and the distal reamers of the first group, the proximal reamers of the second group and the distal reamers of the first group, and the proximal reamers of the second group and the distal reamers of the second group differ from each other by at least one of the module increment values, such that the proximal end of the distal reamer of the first group is positioned adjacent to the distal ends of the proximal reamers of the first and second groups, and the distal end of the proximal reamer of the second group is positioned adjacent to the proximal ends of the distal reamers of the first and second groups. (2) The diameter of the distal end of the cutting portion of at least one of the proximal reamers of the first group is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the first group. The diameter of the distal end of the cutting portion of at least one of the proximal reamers of the second group is equal to, or approximately equal to, the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the first group. The set according to Embodiment 1, wherein the diameter of the distal end of the cutting portion of at least one of the proximal reamers of the second group is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the second group. (3) The set according to Embodiment 1 or 2, wherein the distal reamer includes an increase in diameter according to a tapered profile between the distal tip and the proximal end of each cutting portion. (4) The set according to any one of embodiments 1 to 3, wherein the proximal reamer includes an increase in diameter according to a tapered profile between the distal end and the proximal end of each cutting portion. (5) The set according to any one of embodiments 1 to 4, wherein each of the cutting portions includes a flute that extends at least axially and / or circumferentially along each of the cutting portions.

[0091] (6) The set of surgical reamers according to any one of embodiments 1 to 5, comprising at least three groups of distal reamers, the set comprising the first group, the second group, and the third group having different diameters and a common axial length greater by the module increment value than the axial length of the distal reamers of the second group. (7) The set of surgical reamers comprises at least three groups of proximal reamers, including the first group, the second group, and the third group having different diameters and a common axial length, wherein each of the reamers in the third group includes a cutting portion having a uniform diameter that extends axially between the distal end and the proximal end of each cutting portion, according to any one of embodiments 1 to 6. (8) The distal reamer further comprises a fourth group and a fifth group, each of the fourth group and the fifth group having a plurality of reamers having different diameters and their respective common axial lengths. Each of the fourth group of reamers includes a cutting portion having an axial length that is greater by the module increment value than the axial length of each of the cutting portions of the reamers in the third group, The set according to Embodiment 7, wherein each of the fifth group of reamers includes a cutting portion having an axial length that is greater by the module increment value than the axial length of each of the cutting portions of the reamers in the fourth group. (9) The set according to Embodiment 8, wherein the diameter of the distal end of the cutting portion of at least one of the proximal reamers of the third group is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the fourth group and / or the distal reamers of the fifth group. (10) The set according to embodiments 6 and 7, wherein the diameter of the distal end of at least one of the cutting portions of the proximal reamers of the third group is equal to or substantially equal to the diameter of the proximal end of at least one of the cutting portions of the distal reamers of the third group.

[0092] (11) The set according to Embodiment 7, wherein the axial length of each of the cutting portions of the reamers of the third group of proximal reamers is equal to or approximately equal to the axial length of the cutting portion of the reamers of the second group of proximal reamers, and the diameter of the cutting portion of the second group of proximal reamers increases according to a tapered profile from the distal end to the proximal end of each cutting portion. (12) Each group of proximal reamers and each group of distal reamers is a set according to any one of embodiments 1 to 11, comprising 2 to 16, 4 to 14, 4 to 12, or 8 to 12 reamers of different diameters. (13) The set according to any one of embodiments 1 to 12, wherein the diameter of the proximal end of each cutting portion of the distal reamer is in the range of 10 to 24 mm or 12 to 22 mm. (14) The set according to any one of embodiments 1 to 13, wherein the diameter of the distal end of each cutting portion of the proximal reamer is in the range of 10 to 24 mm or 12 to 22 mm. (15) The set according to any one of embodiments 1 to 14, wherein the axial length of the reamer of the proximal reamer of the second group is in the range of 80 to 110 mm, 85 to 105 mm, or 90 to 100 mm.

[0093] (16) The set according to any one of embodiments 1 to 15, wherein the axial length of the reamer of the distal reamer of the first group is in the range of 125 to 155 mm, 130 to 150 mm, or 135 to 145 mm. (17) The set according to any one of embodiments 1 to 16, wherein the axial length of the reamer of the proximal reamer of the first group is in the range of 30 to 60 mm, 35 to 55 mm, or 40 to 50 mm. (18) The set according to any of Embodiments 1 to 17, wherein the axial length of the reamer of the distal reamer of the second group is in the range of 175 to 205 mm, 180 to 200 mm, or 185 to 195 mm. (19) The set according to any one of embodiments 1 to 18, wherein the module increment value is in the range of 35 to 65 mm, 40 to 60 mm, or 45 to 55 mm. (20) A surgical device for preparing a bone site for receiving an implant, A set of surgical reamers as described in any of Embodiments 1 to 19, A first implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the implant has a predetermined gauge value corresponding to the diameter at a predetermined axial position on the stem, A surgical device providing at least one gauge-matched distal reamer, wherein at least one reamer from at least one of the first group and the second group includes a cutting portion, the cutting portion having a gauge value corresponding to the diameter at a predetermined axial position on the cutting portion, which is equal to the gauge value of the implant.

[0094] (21) The apparatus according to embodiment 20, wherein the predetermined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion. (22) The apparatus according to Embodiment 20, wherein the implant is positioned in line with the aligned distal reamer, the cutting portion and the stem are aligned parallel or substantially parallel, and the distal tip of the stem is aligned coaxially with the distal tip of the cutting portion of the distal reamer, and the axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance. (23) A second implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the second implant has a predetermined gauge value corresponding to the diameter at a predetermined axial position on the stem, At least one reamer from at least one of the distal reamers of the first group and the second group includes a cutting portion, the cutting portion having a gauge value corresponding to the diameter at a predetermined axial position on the cutting portion, which is equal to the gauge value of the implant, thereby providing at least one gauge-matched distal reamer. The apparatus according to embodiment 22, wherein the axial length of the second implant is greater than that of the first implant, and the second gauge-matched distal reamer has an axial length greater than that of the first gauge-matched distal reamer. (24) The apparatus according to embodiment 23, wherein the predetermined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion. (25) The apparatus according to Embodiment 24, wherein the implant is positioned alongside at least one gauge-matched distal reamer, the cutting portion and the stem are aligned parallel or substantially parallel, and the distal tip of the stem is aligned coaxially with the distal tip of the cutting portion of the distal reamer, and the axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance.

[0095] (26) A surgical method for preparing the surgical site and implanting an implant, Selecting a distal reamer from the first group and the second group described in Embodiment 1 by matching a predetermined gauge value of the implant to be embedded with a predetermined gauge value of one of the distal reamers from the first group and the second group, Using the selected gauge-matched distal reamer, material is cut from a distal position at the patient's surgical site, Based on the axial length of the implant to be embedded and / or the gauge value, a proximal reamer is selected from one of the first group and the second group of proximal reamers, such that the combined axial length of the selected distal reamer and the cutting portion of the selected proximal reamer is shorter than the axial length of the implant as measured between the distal tip of the implant stem and the center point of the implant head. Using the selected proximal reamer, material is cut from the proximal position of the surgical site, A surgical method comprising implanting the implant at the surgical site within the patient. (27) The method of Embodiment 26 as dependent on Embodiment 7, comprising: evaluating the state or condition of the material at the surgical site after the step of cutting the material with the distal reamer; and selecting one of the proximal reamers from the first group, the second group, or the third group before the step of cutting the material with the selected proximal reamer. (28) If the proximal reamer is selected from group 1 or group 2, the implant to be embedded is a one-piece implant, or If the proximal reamer is selected from the proximal reamers of group 3, the implant is a modular implant having a head that can be removably attached to the stem, The method according to Embodiment 27, wherein the selected distal reamer is configured for sequential use to cut material at the surgical site using either the proximal reamers of the first group and the second group or the proximal reamers of the third group.

Claims

1. This is a set of surgical reamers, A plurality of distal reamers, each having a cutting portion extending between a distal tip and a proximal tip, wherein the plurality of distal reamers include at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length that is greater by a module increment than the first axial length, A plurality of proximal reamers, each having a cutting portion extending between a distal end and a proximal end, wherein the plurality of proximal reamers include at least a first group having different diameters and a common first axial length, and a second group having different diameters and a common second axial length that is greater than the first axial length of the proximal reamer by the module increment value, A set of surgical reamers, wherein the distal reamers and proximal reamers are configured such that the combined axial lengths of the cutting portions of the proximal reamers of the first group and the distal reamers of the first group, the proximal reamers of the second group and the distal reamers of the first group, and the proximal reamers of the second group and the distal reamers of the second group differ from each other by at least one of the module increment values, such that the proximal end of the distal reamer of the first group can be positioned adjacent to the distal ends of the proximal reamers of the first group and the proximal reamers of the second group, and the distal end of the proximal reamer of the second group can be positioned adjacent to the proximal ends of the distal reamers of the first group and the proximal reamers of the second group.

2. The diameter of the distal end of the cutting portion of at least one of the proximal reamers of the first group is equal to, or approximately equal to, the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the first group. The diameter of the distal end of the cutting portion of at least one of the proximal reamers of the second group is equal to, or approximately equal to, the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the first group. The set according to claim 1, wherein the diameter of the distal end of the cutting portion of at least one of the proximal reamers of the second group is equal to or substantially equal to the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the second group.

3. The set according to claim 1 or 2, wherein the distal reamer includes an increase in diameter according to a tapered profile between the distal tip and the proximal end of each cutting portion.

4. The set according to claim 1, wherein the proximal reamer includes an increase in diameter according to a tapered profile between the distal and proximal ends of each cutting portion.

5. The set according to claim 1, wherein each of the cut portions includes a flute that extends at least axially and / or circumferentially along each of the cut portions.

6. The set of surgical reamers according to claim 1, comprising at least three groups of distal reamers, the first group, the second group, and the third group having different diameters and a common axial length greater by the module increment value than the axial length of the distal reamers of the second group.

7. The set of surgical reamers comprises at least three groups of proximal reamers, including the first group, the second group, and the third group having different diameters and a common axial length, wherein each of the reamers in the third group includes a cutting portion having a uniform diameter extending axially between the distal end and the proximal end of each cutting portion, according to claim 1.

8. The distal reamer further comprises a fourth group and a fifth group, each of which has a plurality of reamers having different diameters and a common axial length. Each of the fourth group of reamers includes a cutting portion having an axial length that is greater by the module increment value than the axial length of each of the cutting portions of the reamers in the third group, The set according to claim 7, wherein each reamer of the fifth group includes a cutting portion having an axial length that is greater by the module increment value than the axial length of each cutting portion of the reamer of the fourth group.

9. The set according to claim 8, wherein the diameter of the distal end of the cutting portion of at least one of the proximal reamers of the third group is equal to or substantially equal to the diameter of the proximal end of the cutting portion of at least one of the distal reamers of the fourth group and / or the distal reamers of the fifth group.

10. The set according to claims 6 and 7, wherein the diameter of the distal end of the cutting portion of at least one of the reamers of the third group of proximal reamers is equal to or substantially equal to the diameter of the proximal end of the cutting portion of at least one of the reamers of the third group of distal reamers.

11. The set according to claim 7, wherein the axial length of each of the cutting portions of the reamers of the third group of proximal reamers is equal to or approximately equal to the axial length of the cutting portion of the reamers of the second group of proximal reamers, and the diameter of the cutting portion of the proximal reamers of the second group increases according to a tapered profile from the distal end to the proximal end of each cutting portion.

12. The set according to claim 1, wherein each group of proximal reamers and each group of distal reamers includes reamers of different diameters in the ranges of 2 to 16, 4 to 14, 4 to 12, or 8 to 12.

13. The set according to claim 1, wherein the diameter of the proximal end of each cutting portion of the distal reamer is in the range of 10 to 24 mm or 12 to 22 mm.

14. The set according to claim 1, wherein the diameter of the distal end of each cutting portion of the proximal reamer is in the range of 10 to 24 mm or 12 to 22 mm.

15. The set according to claim 1, wherein the axial length of the reamer of the proximal reamer of the second group is in the range of 80 to 110 mm, 85 to 105 mm, or 90 to 100 mm.

16. The set according to claim 1, wherein the axial length of the reamer of the distal reamer of the first group is in the range of 125 to 155 mm, 130 to 150 mm, or 135 to 145 mm.

17. The set according to claim 1, wherein the axial length of the proximal reamer of the first group is in the range of 30 to 60 mm, 35 to 55 mm, or 40 to 50 mm.

18. The set according to claim 1, wherein the axial length of the reamer of the distal reamer of the second group is in the range of 175 to 205 mm, 180 to 200 mm, or 185 to 195 mm.

19. The set according to claim 1, wherein the module increment value is within the range of 35 to 65 mm, 40 to 60 mm, or 45 to 55 mm.

20. A surgical device for preparing a bone site for receiving an implant, A set of surgical reamers according to any one of claims 1 to 19, A first implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the implant has a predetermined gauge value corresponding to the diameter at a predetermined axial position on the stem, A surgical device providing at least one gauge-matched distal reamer, wherein at least one reamer from at least one of the first group and the second group includes a cutting portion, the cutting portion having a gauge value corresponding to the diameter at a predetermined axial position on the cutting portion, which is equal to the gauge value of the implant.

21. The apparatus according to claim 20, wherein the predetermined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion.

22. The apparatus according to claim 20, wherein the implant is positioned alongside the aligned distal reamer, the cutting portion and the stem are aligned parallel or substantially parallel, and the distal tip of the stem is aligned coaxially with the distal tip of the cutting portion of the distal reamer, and the axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance.

23. A second implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, wherein the second implant has a predetermined gauge value corresponding to the diameter at a predetermined axial position on the stem, At least one reamer from at least one of the distal reamers of the first group and the second group includes a cutting portion, the cutting portion having a gauge value corresponding to the diameter at a predetermined axial position on the cutting portion, which is equal to the gauge value of the implant, thereby providing at least one gauge-matched distal reamer. The apparatus according to claim 22, wherein the axial length of the second implant is greater than that of the first implant, and the second gauge-matched distal reamer has an axial length greater than that of the first gauge-matched distal reamer.

24. The apparatus according to claim 23, wherein the predetermined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion.

25. The apparatus according to claim 24, wherein the implant is positioned alongside at least one gauge-matched distal reamer, the cutting portion and the stem are aligned parallel or substantially parallel, and the distal tip of the stem is aligned coaxially with the distal tip of the cutting portion of the distal reamer, and the axial separation distance between the axial position of the center of the head and the proximal end of the cutting portion is a predetermined set distance.

26. This is a surgical method that involves preparing the surgical site and implanting the implant. Selecting a distal reamer from the first group and the second group of distal reamers as described in claim 1 by matching a predetermined gauge value of the implant to be embedded with a predetermined gauge value of one of the distal reamers from the first group and the second group, Using the selected gauge-matched distal reamer, material is cut from a distal position at the patient's surgical site, Based on the axial length of the implant to be embedded and / or the gauge value, a proximal reamer is selected from one of the first group and the second group of proximal reamers, such that the combined axial length of the selected distal reamer and the cutting portion of the selected proximal reamer is shorter than the axial length of the implant as measured between the distal tip of the implant stem and the center point of the implant head. Using the selected proximal reamer, material is cut from the proximal position of the surgical site, A surgical method comprising implanting the implant at the surgical site within the patient.

27. The method according to claim 26, as dependent on claim 7, comprising: evaluating the state or condition of the material at the surgical site after the step of cutting the material with the distal reamer; and selecting one of the proximal reamers from the first group, the second group, or the third group before the step of cutting the material with the selected proximal reamer.

28. If the proximal reamer is selected from group 1 or group 2, the implanted implant is a one-piece implant, or If the proximal reamer is selected from the proximal reamers of group 3, the implant is a modular implant having a head that can be removably attached to the stem. The method according to claim 27, wherein the selected distal reamer is configured for sequential use to cut material at the surgical site using any of the proximal reamers of the first group and the second group or the proximal reamer of the third group.

Images