Surgical instrument, reamer set and surgical method
The modularly designed distal and proximal reaming drill set solves the problems of large instrument inventory and insufficient surgical adaptability in the existing technology, realizes efficient interchangeability and flexible use of instruments in surgical operations, and adapts to the needs of implants of different types and sizes.
Patent Information
- Application Number
- CN202480016865.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-03-08
- Filing Date
- 2024-03-07
- Publication Date
- 2025-10-17
AI Technical Summary
Existing surgical procedures require a variety of reamers of different sizes and types, resulting in a large inventory of instruments and making it difficult to quickly replace and adapt to changes in the patient's anatomy during surgery, affecting surgical efficiency and flexibility.
A modular surgical instrument set is provided, including distal and proximal reamer drills, each set of reamer drills having the same length but different diameters. Compatibility and interchangeability between instruments are achieved through a modular incremental value design, allowing surgeons to flexibly select and combine them according to the patient's anatomical structure and implant type.
It reduces instrument inventory, improves surgical flexibility and efficiency, can quickly adapt to the needs of implants of different types and sizes, and does not require complete re-preparation of the surgical site, thereby enhancing the adaptability and interchangeability of surgical procedures.
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Figure CN120813310A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present disclosure relates to surgical instruments, kits incorporating such surgical instruments, and surgical methods using such instruments. The present disclosure relates particularly, but not exclusively, to reaming / cutting instruments, and in particular to surgical site preparation reaming instruments. BACKGROUND
[0002] Orthopedic surgeons must create openings or cavities in long bones for various reasons, including fracture fixation and implantation of a rod-based prosthesis. Rods are used in prosthetic joint implants to anchor the prosthesis in a bone cavity. The bone that receives the rod is typically prepared by drilling a hole and creating an opening sized and contoured to receive the implant rod. Typically for joint reconstruction, a rod is inserted into a cavity within the bone and a joint-bearing component (head) disposed at or coupled to the rod extends outwardly to couple to a receiving socket or other region, completing the joint.
[0003] To prepare the bone, such as a femur, a reamer is often used. Different types and / or sizes of surgical implants can be appropriate for a particular surgical problem or site, and can require changing the surgical plan. This often requires a large instrument tray, as surgical implants often come with their own reamer kit, and often with multiple sets of reamers of different types. Additionally, depending on the size of the rod being implanted, the same reamer can be used to ream to a variety of different depths. A large number of reamers represents an undesirable large inventory of instruments that must be maintained.
[0004] A reamer typically includes a rotating reamer with a cutting structure, such as flutes, a body that the surgeon can hold the instrument, and a coupling for connection to a rotating drive source, which is typically a power tool, but can also be a manual tool. Often, the reamer can be removed from the instrument, for example due to the size of the patient, or to gradually increase the size of the cavity to match the size of the planned prosthesis. Therefore, a releasable attachment mechanism is often provided to allow the reamer to be replaceably attached to the rest of the reamer instrument, so that different sizes of reamer can be used.
[0005] During hip replacement surgery, it is often necessary for the surgeon to be provided with some degree of flexibility in selecting a prosthesis. In particular, the anatomy of the bone into which the prosthesis is to be implanted can vary from patient to patient. Monolithic or monoblock prostheses comprise a head (or head mount), a stem and a neck integrally formed. Typically, there can be a range of different sizes of prosthesis from which the surgeon can select to match the size of the patient's femur. For example, the patient's femur can be relatively long or relatively short, requiring the use of a femoral prosthesis comprising a relatively long or relatively short stem, respectively. Furthermore, in some cases, such as when a relatively long stem length is required, the stem must also be curved to conform to the patient's femoral anatomy. Modular prostheses are constructed in a modular form, so that individual components can be selected to accommodate the needs of the patient's anatomy. For example, a typical modular prosthesis comprises a proximal body component that can be assembled to any one of a plurality of distal stem components. This design allows the distal stem component to be selected and then implanted into the patient's bone in a position that conforms to the patient's anatomy, while also allowing a degree of independent positioning of the proximal body component.
[0006] Accordingly, it would be beneficial to reduce the number of surgical instruments and / or surgical reamers required. Additionally, it would be beneficial to allow greater interchangeability between different types of implants during a surgical procedure and in response to a surgeon's assessment that a second, different implant or implant type can be more suitable than a first, intended implant. It would be advantageous if such interchangeability could be achieved via a minimum number of surgical instruments, particularly bone preparation reamers. SUMMARY
[0007] It is an object of the present concept to provide a set of surgical instruments, particularly reamers for preparing a surgical site, with greater compatibility and interchangeability between different surgical instruments / reamers of the set. Such a configuration is advantageous in that a surgical site can be prepared in a variety of different combinations via the combined use of multiple instruments / reamers of the set. It is a further particular object to provide a set of surgical instruments / reamers that are suitable for use in any combination, and particularly in an interchangeable combination, to prepare a surgical site to receive implants of different types and / or sizes during a surgical procedure. It is a further particular object to provide a set of instruments / reamers that can be used to prepare a surgical site to receive a first type of implant, while allowing the same prepared surgical site to be suitable for receiving a different, second type of implant without the need to completely re-prepare the site.
[0008] Another specific object is to provide a set of surgical instruments having different instrument / reamer groups, wherein the groups can be combined and used interchangeably to prepare a surgical site to receive at least a first type of implant and a second type of implant. Another specific object is to provide a surgical reamer set that is organized into groups including distal reamer and proximal reamer groups and that has interchangeable compatibility between different distal and proximal reamer groups.
[0009] These objectives are achieved by a set of surgical instruments, specifically reamers organized into groups of proximal and distal reamers. Each group includes a series of reamers having the same common length but different diameters. This configuration is provided for both the distal and proximal reamer groups, with each group optionally being provided on a tray.
[0010] Specifically, the present surgical instrument / reamer set is designed to achieve modularity via the respective axial lengths and diameters of the distal and proximal ends of the respective cutting portions of each of the reamers. That is, the present modular reamer set includes groups of cutting portions of fixed length but variable diameter such that the diameters of the distal and proximal ends of the reamers of different groups match, overlap and / or are the same in all, some or multiple different groups. The modular construction of the present surgical instrument / reamer set allows the surgeon to identify an implant that matches the patient, particularly with respect to the length of the patient's femur, and particularly the gauge, and then identify the distal reamer set required as an initial step to prepare the bone site. The present modular instrument set further enables the surgeon to first select one or more different proximal reamer sets to prepare the bone site as an intermediate or final stage, while also allowing the surgeon to switch to different implants depending on the state or condition of the patient's bone and / or surgical site. Specifically, the present concept provides such interchangeability without the need for further / additional distal reaming and by completing preparation of the surgical site using one or more reamers from a selected proximal reamer set that is identified as matching and suitable for a second type of surgical implant identified by the surgeon.
[0011] According to a first aspect of the present concept, there is provided a surgical reamer kit comprising: a plurality of distal reamers, each distal reamer having a cutting portion extending between a distal tip and a proximal end, the distal reamers comprising 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, the second axial length being greater than the first axial length by a modular incremental value; a plurality of proximal reamers, each proximal reamer having a cutting portion extending between a distal end and a proximal end, the proximal reamers comprising 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, the second axial length being greater than the first axial length of the proximal reamer by the modular incremental value; the distal reamers and the proximal reamers being configured such that the proximal ends of the first group of distal reamers are positionable adjacent to the distal ends of the first group of proximal reamers and the second group of proximal reamers, and the distal ends of the second group of proximal reamers are positionable adjacent to the proximal ends of the first group of distal reamers and the second group of distal reamers, such that respective combined axial lengths of the following combinations of cutting portions differ from each other by at least one of the modular incremental values: the first group of proximal reamers plus the first group of distal reamers; the second group of proximal reamers plus the first group of distal reamers; and the second group of proximal reamers plus the second group of distal reamers.
[0012] The modular incremental value referred to herein comprises a qualitative and quantitative axial length measured between two spatially separated axial positions. The modular incremental value can be a fixed integer or decimal. The modular incremental can be measured from an axial end of any of the cutting portions described herein, wherein such ends of the cutting portions include the distal cutting tip as well as the proximal and distal ends.
[0013] Optionally, the diameter of the distal end of the cutting portion of at least one proximal reamer of the first group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer of the first group of distal reamers; the diameter of the distal end of the cutting portion of at least one proximal reamer of the second group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer of the first group of distal reamers; and the diameter of the distal end of the cutting portion of at least one proximal reamer of the second group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer of the second group of distal reamers.
[0014] Optionally, the distal reamers comprise an increase in diameter according to a tapered profile between the distal tip and the proximal end of each respective cutting portion. Optionally, the proximal reamers comprise an increase in diameter according to a tapered profile between the distal end and the proximal end of each respective cutting portion.
[0015] Optionally, the respective cutting portion comprises a slot extending at least axially and / or circumferentially along each respective cutting portion.
[0016] Optionally, the set of surgical reamers comprises at least three groups of distal reamers, including a first group, a second group, and a third group, the third group having a different diameter and a common axial length, the common axial length being greater than the axial length of the second group of distal reamers by the modular increment value. Optionally, the set of surgical reamers comprises at least three groups of proximal reamers, including a first group, a second group, and a third group, the third group having a different diameter and a common axial length, each of the reamers within the third group comprising a cutting portion having a uniform diameter extending axially between a distal end and a proximal end of each cutting portion. Optionally, the distal reamers further comprise a fourth group and a fifth group, each respective group having a plurality of reamers having a different diameter and a respective common axial length, wherein: the fourth group of reamers each comprise a cutting portion having an axial length that is greater than the axial length of the cutting portion of each of the reamers of the third group by the modular increment value; and the fifth group of reamers each comprise a cutting portion having an axial length that is greater than the axial length of the cutting portion of each of the reamers of the fourth group by the modular increment value.
[0017] Optionally, the diameter of the distal end of the cutting portion of at least one proximal reamer of the third group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer of the fourth group of distal reamers and / or the fifth group of distal reamers. Optionally, the diameter of the distal end of the cutting portion of at least one reamer of the third group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one reamer of the third group of distal reamers.
[0018] Optionally, the axial length of the cutting portion of each 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, wherein the diameter of the cutting portion of the second group of proximal reamers increases according to a tapered profile from a distal end to a proximal end of each respective cutting portion.
[0019] Optionally, each of the sets of proximal reamers and distal reamers comprises 2 to 16, 4 to 14, 4 to 12, or 8 to 12 reamers of different diameters. Optionally, the diameter of the proximal end of the respective cutting portion of the distal reamers is in the range of 10 mm to 24 mm or 12 mm to 22 mm. Optionally, the diameter of the distal end of the respective cutting portion of the proximal reamers is in the range of 10 mm to 24 mm or 12 mm to 22 mm. Optionally, the axial length of the reamers of the second set of proximal reamers is in the range of 80 mm to 110 mm, 85 mm to 105 mm, or 90 mm to 100 mm. Optionally, the axial length of the reamers of the first set of distal reamers is in the range of 125 mm to 155 mm, 130 mm to 150 mm, or 135 mm to 145 mm. Optionally, the axial length of the reamers of the first set of proximal reamers is in the range of 30 mm to 60 mm, 35 mm to 55 mm, or 40 mm to 50 mm. Optionally, the axial length of the reamers of the second set of distal reamers is in the range of 175 mm to 205 mm, 180 mm to 200 mm, or 185 mm to 195 mm. Optionally, the modular increment value is in the range of 20 mm to 75 mm, 25 mm to 70 mm, 30 mm to 65 mm, 35 mm to 65 mm, 40 mm to 60 mm, or 45 mm to 55 mm.
[0020] According to another aspect of the present concept, there is provided a surgical device for preparing a bone site to receive an implant, the surgical device comprising: a surgical reamer set according to any preceding claim; and a first implant having a stem, a neck, and a head or head mount connected to the stem by the neck, the implant having a predefined gauge value corresponding to a diameter at a predefined axial location on the stem; wherein at least one reamer of at least one of the first set of distal reamers and the second set of distal reamers comprises a cutting portion having a gauge value corresponding to a diameter at a predefined axial location on the cutting portion, the gauge value being equal to the gauge value of the implant, to provide at least one gauge-matched distal reamer.
[0021] Optionally, the predefined axial location on the cutting portion of the distal reamer is at the proximal end of the cutting portion.
[0022] Optionally, in case the implant is positioned side-by-side to the matching distal reamer, and in case the cutting portion and the stem are aligned parallel or almost parallel and the distal tip of the stem is coaxially aligned with the distal tip of the cutting portion of the distal reamer, the axial separation distance between the axial location at the center of the head and the proximal end of the cutting portion is a predefined set distance.
[0023] Optionally, the second implant has a stem, a neck, and a head or head mount connected to the shaft via the neck, the implant having a predefined gauge value corresponding to a diameter at a predefined axial location on the stem; wherein at least one reamer of at least one of the first set of distal reamers and the second set of distal reamers comprises a cutting portion having a gauge value corresponding to a diameter at a predefined axial location on the cutting portion, the gauge value being equal to the gauge value of the implant to provide at least one gauge-matched distal reamer; wherein the axial length of the second implant is greater than the first implant, and the axial length of the second gauge-matched distal reamer is greater than the axial length of the first gauge-matched distal reamer.
[0024] Optionally, the predefined axial location on the cutting portion of the distal reamer is at a proximal end of the cutting portion.
[0025] Optionally, in the case where the implant is positioned side-by-side to the at least one gauge-matched distal reamer, and in the case where the cutting portion and the stem are aligned parallel or almost parallel and the distal tip of the stem is coaxially aligned with the distal tip of the cutting portion of the distal reamer, the axial separation distance between the axial location at the center of the head and the proximal end of the cutting portion is a predefined set distance.
[0026] According to another aspect of the present concept, there is provided a surgical method of preparing a surgical site and implanting an implant, the surgical method comprising: selecting a distal reamer from the first set of distal reamers and the second set of distal reamers of claim 1 by matching a predefined gauge value of an implant to be implanted with a predefined gauge value of one of the first set of distal reamers and the second set of distal reamers; cutting material from a distal location at the surgical site of a patient using the selected gauge-matched distal reamer; selecting a proximal reamer from one of the first set of proximal reamers and the second set of proximal reamers based on an axial length and / or the 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 less than the axial length of the implant measured between a distal tip of a stem of the implant and a center point of a head of the implant; cutting material from a proximal location at the surgical site using the selected proximal reamer; and implanting the implant into the surgical site of the patient.
[0027] Optionally, the state or condition of the material at the surgical site is assessed after the step of cutting material using the distal reamer, and one of the first set of proximal reamers, the second set of proximal reamers, or the third set of proximal reamers is selected prior to the step of cutting material with the selected proximal reamer.
[0028] Optionally, if the proximal reamer is selected from the first or second group, the implant to be implanted is a monolithic body implant; or if the proximal reamer is selected from the third group of proximal reamers, the implant is a modular implant having a proximal body (a neck for mounting a head) that can be detachably mounted to the distal stem; such that the selected distal reamer is configured for sequential use to cut material at the surgical site with the first and second groups of proximal reamers or the third group of proximal reamers.
[0029] According to another aspect of the present concept, there is provided a surgical reamer kit comprising: a plurality of distal reamers, each distal reamer having a cutting portion extending between a distal tip and a proximal end, the distal reamers comprising 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, the second axial length being greater than the first axial length; a plurality of proximal reamers, each proximal reamer having a cutting portion extending between a distal end and a proximal end, the proximal reamers comprising 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, the second axial length being 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 are positionable 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 are positionable adjacent to the proximal ends of the first and second groups of distal reamers.
[0031] Preferably, the combined axial lengths of the following combinations of cutting portions differ from each other by at least one of said modular incremental values: the first group of proximal reamers plus the first group of distal reamers; the second group of proximal reamers plus the first group of distal reamers; and the second group of proximal reamers plus the second group of distal reamers.
[0032] According to another aspect, the disclosure provides a kit of surgical instruments, the kit comprising two or more first type surgical instruments, the first type surgical instruments can comprise: a proximal end and a distal end; and / or one or more cutting elements provided by a distal portion between the proximal end and the distal end; and / or a location having a location diameter, the location can be intermediate the proximal end and the distal end; wherein at least two of the first type surgical instruments can further comprise: a range between the proximal end and the distal end that is different from each other; and / or the location having the location diameter has a same diameter from each other; and / or the location having the location diameter has a same distance from the proximal end of the first type surgical instruments from each other.
[0033] Optionally, the three and / or four and / or all first-type surgical instruments in the set may have different ranges between the proximal and distal ends. Optionally, the three and / or four and / or all first-type surgical instruments in the set may have positions with diameters that are identical to one another (predefined axial positions). Optionally, the three and / or four and / or all first-type surgical instruments in the set may have positions with position diameters that are identically spaced relative to the proximal ends of the first-type surgical instruments.
[0034] Optionally, the first type of surgical instrument can be a reamer. The first type of surgical instrument can be a distal reamer. The first type of surgical instrument can be provided with a tapered portion in the distal portion, for example. The tapered portion can be fully tapered. The one or more cutting elements can be provided in the tapered portion. The one or more cutting portions can extend distally and / or radially, for example, in an inclined manner. The proximal end can be provided with a mounting element. The mounting element can connect the first type of surgical instrument to the driving instrument during use. The mounting element can interact with a second type of surgical tool (e.g., a different type of reamer) during use, for example, to receive the second type of surgical tool. The mounting element can be a shaft or a rod. The mounting element can have a mounting element diameter. The mounting diameter can be smaller than the position diameter and / or smaller than the inner hole diameter of the second type of surgical tool.
[0035] Optionally, one or more or all of the first type of instruments may have mounting elements with the same extent from proximal to distal. The distal end may be provided with an enlarged tapered portion. Optionally, the location may be a cross-sectional location through the surgical instrument, for example, perpendicular to the axis of the surgical instrument. The location may be a standard location. The location diameter may be the maximum diameter at the location. The location diameter may be the minimum diameter at the location. The location diameter may be the average diameter around the perimeter of the location. Optionally, the distal portion of the one or more cutting elements may extend distally of the location used for one or more or all of the first type of surgical instruments. The distal portion of the one or more cutting elements may extend proximally of the location used for at least one or two of the first type of surgical instruments. The distal portion of the one or more cutting elements may extend both distally and proximally of the location used for at least one or two of the first type of surgical instruments. The distal portion of the one or more cutting elements may not extend proximally of the location used for at least one or two of the first type of surgical instruments. The set of first type surgical instruments may be provided with one or more types of surgical implants. In the case where the set of the first type of surgical instruments is provided together with one or more types of surgical implants, the positions having the same diameter as each other may have the same distance relative to the head portion (e.g., the center of the head) of the surgical implant. This type of surgical implant may be a modular surgical implant.
[0036] Optionally, in case the set of first type surgical instruments is provided together with one or more types of surgical implants, the positions having the same diameter as each other can have the same distance from the start of the slot on the surgical implant, e.g. the center of the head, relative to the proximal end of the surgical implant. Such type of surgical implant can be a monolithic or one-piece surgical implant.
[0037] The set of first type surgical instruments can be provided together with one or more sets of second type surgical instruments.
[0038] Another aspect of the present disclosure can include any of the features, options and possibilities set out elsewhere in the present specification, including in the other aspects.
[0039] According to another aspect, the present disclosure provides a set of surgical instruments, the set comprising two or more first type surgical instruments, the first type surgical instruments can comprise: a proximal end and a distal end; and / or one or more cutting elements provided by a cutting portion disposed between the proximal end and the distal end, the cutting portion can have a proximal limit; wherein at least two of the first type surgical instruments further can comprise: a range between the proximal end and the distal end that is different from each other; and / or the proximal limit of the cutting portion has the same distance from the proximal end of the first type surgical instruments as each other.
[0040] Optionally, the cutting portion can have a distal limit at the distal end of the surgical instrument. Optionally, at least two of the first type surgical instruments further can comprise: a range between the proximal end and the distal end that is different from each other; a position having the same diameter as each other; and the position having the diameter of the position has the same distance from the proximal end of the first type surgical instruments as each other. Optionally, two or more of the first type surgical instruments can have a first same distance for the proximal limit of the cutting portion. Two or more of the first type surgical instruments can have a second same distance for the proximal limit of the cutting portion. The first same distance can be smaller than the second same distance. In case two or more of the first type surgical instruments have the position, the first same distance can be proximal to the position. In case two or more of the first type surgical instruments have the position, the second same distance can coincide with the position.
[0041] Optionally, the three and / or four and / or all of the first type surgical instruments in the set can have ranges between the proximal end and the distal end that are different from one another. The three and / or four and / or all of the first type surgical instruments in the set can have positions that have position diameters that are the same diameter from one another. Optionally, the three and / or four and / or all of the first type surgical instruments in the set can have positions that have position diameters that are the same distance from the proximal end of the first type surgical instrument from one another.
[0042] Optionally, two or more of the second type surgical instruments can have a first same distance from a proximal limit of the cutting portion to a distal limit of the cutting portion. Two or more of the first type surgical instruments can have a second same distance from a proximal limit of the cutting portion to a distal limit of the cutting portion. The first same distance can be less than the second same distance.
[0043] According to another aspect, the present disclosure provides a surgical method that can include providing a set of first type surgical instruments according to one aspect of the application described and claimed herein; and / or selecting a first type first surgical instrument from the set of instruments; and / or using the first surgical instrument to cut material from a surgical site of a patient; and / or providing a first type surgical implant and a second type surgical implant; and / or providing two sets of second type surgical instruments, a first set of the two sets being different from a second set of the two sets in one or more physical characteristics of the surgical instruments; and / or performing an evaluation to use the first type surgical implant or the second type surgical implant for the patient; and / or if the first type surgical implant is to be used, then also selecting to use a first set of the second type surgical instruments; and / or if the second type surgical implant is to be used, then also selecting to use a second set of the second type 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 can be a non-customizable implant. The first type of surgical implant can be a monolithic or single piece implant.
[0045] Optionally, the second type surgical implant can be a customizable implant. The second type of surgical implant can be a modular implant. The second type implant can include a separate distal stem portion and a separate proximal stem and head portion. A variety of different characteristics of distal stem portions and / or proximal stem and head portions can be provided, for example, to select from.
[0046] Optionally, the first type of surgical implant and / or the second type of surgical implant can differ in the following: profile and / or proximal to distal extent, lateral extent of the head section and / or inclination of the head section and / or profile of the head section and / or the slots (including their profile and / or starting position and / or end position and / or inclination), and / or whether the surgical implant is formed from a single element or from two or more elements that are connected together (including modular implants, where a stem part and a head part are connected together and are selected from a variety of different stem parts and / or head parts).
[0047] The first set of second type surgical instruments can be reamers. The first set of second type surgical instruments can be proximal reamers. The first set of second type surgical instruments can be provided with a tapered portion, for example in the distal portion. The tapered portion can be a partial taper. The first set of second type surgical instruments can be provided with a conical portion. Optionally, the first set of second type instruments can comprise one or more cutting elements, which can be provided in the tapered portion or the conical portion. The one or more cutting portions can for example extend distally and / or radially in an inclined manner.
[0048] Optionally, the first set of second type instruments can comprise a proximal end portion, which can be provided with a mounting element. The mounting element can connect the second type surgical instrument to a driving instrument in use. The mounting element can be a shaft or a stem. The mounting element can have a mounting element diameter. The mounting element can be smaller than the location diameter. Optionally, one or more or all of the first set of second type instruments can have the same extent of the mounting element from proximal to distal. Optionally, the first set of second type instruments can be provided with a planar distal, for example perpendicular to the axis of the instrument.
[0049] The second set of second type surgical instruments can be reamers. The second set of second type surgical instruments can be proximal reamers. The second set of second type surgical instruments can be provided with a non-tapered portion, for example in the distal portion. The non-tapered portion can be a cylindrical portion.
[0050] The second set of second type instruments can comprise one or more cutting elements, which can be provided in the cylindrical portion. The one or more cutting portions can for example extend distally and / or radially in an inclined manner. Optionally, the second set of second type instruments can comprise a proximal end portion, which can be provided with a mounting element. The mounting element can connect the second type surgical instrument to a driving instrument in use. The mounting element can be a shaft or a stem. The mounting element can have a mounting element diameter. The mounting element can be smaller than the location diameter.
[0051] Optionally, one or more or all of the second set of second type instruments can have the same range of mounting elements from proximal to distal. Optionally, the second set of second type instruments can be provided with a distal plane, e.g. perpendicular to the axis of the instrument. Optionally, the second type instruments can have a proximal to distal range that is less than the proximal to distal range of the first type instruments.
[0052] Optionally, the second type instrument set can include, for the first set and / or the second set, two or more instruments having a first proximal to distal range of cutting elements, the range being the same. The second type instruments can include, for the first set and / or the second set, two or more instruments having a second proximal to distal range of cutting elements, the range being the same. The first proximal to distal range can be less than the second proximal to distal range.
[0053] According to another aspect, the present disclosure provides a surgical method, which can include: providing a set of first type surgical instruments according to aspects of the application described and claimed herein; and / or selecting a first type first surgical instrument from the set of instruments; and / or using the first surgical instrument to cut material from a surgical site of a patient; and / or providing a first type surgical implant and a second type surgical implant; and / or providing two sets of second type surgical instruments, a first set of the two sets differing from a second set of the two sets in one or more physical characteristics of the surgical instruments; and / or performing an assessment to use the first type surgical implant or the second type surgical implant for the patient; and / or if the first type surgical implant is to be used, then also selecting to use a first set of second type surgical instruments; and / or if the second type surgical implant is to be used, then also selecting to use a second set of second type 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 type and / or the second type surgical implant can be a customizable implant. The first type and / or the second type surgical implant can be a modular implant. The first type and / or the second type implant can include a separate distal stem portion and a separate proximal stem and head portion. A plurality of different characteristics of distal stem portions and / or proximal stem and head portions can be provided, e.g. to select from. BRIEF DESCRIPTION OF DRAWINGS
[0055] Specific embodiments of the present subject matter will now be described, by way of example only, and with reference to the drawings, in which:
[0056] Figure 1A is a plan view of a tray of distal reamers having respective cutting portions of different diameters and having a first common length, according to a specific embodiment;
[0057] Figure 1B is a plan view of a tray of distal reamers according to an embodiment for preparing a skeletal site to receive a monolithic body implant, the distal reamers having respective cutting portions of different diameters and a second common length;
[0058] Figure 1C is a plan view of a tray of distal reamers according to an embodiment for preparing a skeletal site to receive a monolithic body implant, the distal reamers having respective cutting portions of different diameters and a third common length;
[0059] Figure 2A is a plan view of a proximal reamer according to an embodiment for preparing a skeletal site to receive a monolithic body implant, the proximal reamer having respective cutting portions of different diameters and a first common length;
[0060] Figure 2B is a plan view of a proximal reamer according to an embodiment for preparing a skeletal site to receive a monolithic body implant, the proximal reamer having respective cutting portions of different diameters and a second common length;
[0061] Figure 2C is a plan view of a proximal reamer according to an embodiment for receiving a modular implant formed from a plurality of separate components, the proximal reamer having respective cutting portions of different diameters and a first common length;
[0062] Figure 3A is a side view of a distal reamer of a first kit corresponding to Figure 1A
[0063] Figure 3B is a side view of a proximal reamer of the kit corresponding to Figure 2B
[0064] Figure 3C is a side view of a proximal reamer of the kit corresponding to Figure 2A
[0065] Figure 3D is a side view of a proximal reamer of the kit corresponding to Figure 2C
[0066] Figure 4 is a schematic view of a hip arthroplasty in which a monolithic body implant is inserted into a pre-prepared surgical site at a patient's skeleton;
[0067] Figure 5 is a schematic illustration of a hip arthroplasty procedure in which a modular implant is inserted into a pre-prepared surgical site at the patient's bone;
[0068] Figure 6 is a schematic illustration of an initial bone preparation stage involving distal reaming of the femoral medullary canal;
[0069] Figure 7 is a schematic illustration of a further stage of the hip arthroplasty procedure involving attachment of a proximal reamer to the proximal end of the distal reamer;
[0070] Figure 8 is a schematic illustration of the assembled combined reaming apparatus of Figure 7 , with the proximal reamer mounted proximally to the distal reamer and inserted within the femoral medullary canal;
[0071] Figure 9A is a front view of a monolithic body integrated hip implant;
[0072] Figure 9B is a side view of the implant of Figure 9A ;
[0073] Figure 10 schematically illustrates axial combination assemblies of proximal and distal reamers having different axial length combinations suitable for preparing a bone site to receive a prosthesis of a desired axial length to match the patient's anatomical profile;
[0074] Figure 11 schematically illustrates interchangeable views of various components of the present concept that enable preparation of a surgical site to receive a prosthesis using proximal and distal reamers according to embodiments of the present concept. DETAILED DESCRIPTION
[0075] The present concept provides a complete set of modular interchangeable surgical site preparation instruments, particularly a collection of distal reamers and proximal reamers configured specifically for bone site preparation suitable for joint arthroplasty. Additionally, the set of instruments enables convenient and efficient "intraoperative" interchange between intended implantation of integrated (monolithic) implants and modular implants via a common distal reaming site preparation. Specifically, the set of instruments includes distal reamers of different length and gauge (diameter) configurations suitable for both monolithic and modular prosthesis implantation. The set of instruments includes at least a first type of proximal reamer and a second type of proximal reamer, each configured specifically for monolithic or modular prostheses.
[0076] Reference is made to Figure 1AThe instrument tray 10 comprises a set of distal reamers 13a. In particular, the tray 10 comprises eleven reamers 13a having the same axial length, but each reamer 13a comprises a different diameter. Each reamer 13a comprises a cutting portion 60 extending between a distal tip 15 and a proximal end 14. The cutting portion 60 comprises a diameter that decreases according to a tapered profile between the end 14 and the tip 15. Each of these reamers 13a comprises a cutting flute 17 spirally extending over the cutting portion 60 between the tip 15 and the end 14. A shaft 16 protrudes proximally from the proximal end 14 and is adapted to be connected to a driving tool (not shown). According to a particular embodiment, the maximum diameter of the reamers 13a within the set 10 varies between 12 mm and 22 mm. Each reamer 13a has a length of 140 mm.
[0077] With reference to Figure 1B The second instrument tray 11 comprises a plurality (eleven) of proximal reamers 13b, each comprising the same configuration, features and functions as the reamers 13a described with reference to Figure 1A However, the reamers 13b comprise a longer axial length, 190 mm, with respect to the reamers 13a. The reamers 13b comprise a maximum diameter of 12 m to 22 m. According to a particular embodiment, the maximum diameter of the reamers 13b varies between 12 mm and 22 mm. Figure 1C The other instrument tray 12 according to Figure 1A and Figure 1B also comprises a plurality (eleven) of distal reamers 13c provided with a cutting portion 60 and having the same features and functions as the reamers 13a described with reference to Figure 1B However, the axial length of the respective cutting portions 60 of the reamers 13c is smaller than the axial length of the reamers 13a and 13b, 120 mm. Therefore, different sets of distal reamers 10, 11, 12 can be used to prepare a surgical site to receive implants of different lengths.
[0078] A set of proximal reamers 18 is provided on another tray comprising thirteen reamers 25a. Each of these proximal reamers 25a comprises a cutting portion 22 extending between a distal end 23 and a proximal end 24. A shaft 21 protrudes proximally from the proximal end 24 and is adapted to be connected to the same driving tool (not shown) that can be attached to the distal reamers 13a to 13c. Each of these reamers 25a, in particular the respective cutting portion 22, comprises the same axial length, but the maximum diameter varies in the range of 12 mm to 22 mm. Figure 2B Another set (eleven) of proximal reamers 19 is illustrated in Fig. 5 mounted within another tray. The proximal reamers 25b comprise the same configuration, features and functions as the reamers 25a described with reference to Figure 2AThe same features and functions described, specifically including cutting portions 22, shafts 21 and corresponding cutting portion tip / distal end 23, 24. Two sets of proximal reamers 25a, 25b include corresponding cutting portions 22 that are tapered to decrease in diameter between the proximal end 24 and the distal end 23. Via the array of different diameters provided and the number of distal and proximal reamers, an overlap is provided between the size of the respective diameters of the proximal end 24 of the proximal reamers 25a, 25b and the diameters of the proximal end 14 of the distal reamers 13a-c. Such a configuration enables the surgeon to select the appropriate proximal reamer from the set 18, 19 having the desired maximum diameter and axial length to work in conjunction with the selected distal reamer(s) of one or more of the sets 10, 11 and 12 at the surgical site. The distal reamer sets 10, 11 and 12 and the proximal reamer sets 18 and 19 are adapted, via the respective tapered diameter profiles, to prepare the surgical site to receive a monolithic (integrated) implant.
[0079] With reference to Figure 2C At another tray, another proximal reamer set 20 is provided. Specifically, the set 20 includes thirteen proximal reamers 26 having corresponding cutting portions 22 defined by tip ends 23, 24 that share Figure 2AThe reamers 26 (and in particular the cutting portions 22) include a uniform diameter between the proximal end 24 and the distal end 23, in accordance with another set 20. In particular, the cutting portions 22 of the reamers 26 are generally conical. However, all of the reamers 25a, 25b, and 25c at the respective cutting portions 22 include cutting flutes similar to the flutes 17 of the distal reamers 13a-13c. The proximal reamer set 20 is thus configured for surgical preparation to receive a modular prosthesis, where the stem is separate from and attachable to the neck portion, which has a head mount / trunnion to mount a femoral head component for fitting within an acetabular cup. The proximal reamer set 20, sets 18 and 19 are adapted for cooperative cutting and coaxial mounting with any of the plurality of distal reamers 13a, 13b, and 13c and combinations thereof. Thus, the respective diameter of the cutting portions 22 at the distal end 23 corresponds to the respective diameter of at least some of the respective diameters of the proximal ends 14 of the cutting portions 60 of the reamers 13a-13c. Advantageously, if during a surgical procedure, the surgeon can alter the surgical procedure from an anticipated implant of a monoblock implant to a modular implant after having evaluated the surgical site, in particular the condition of the bone and / or tissue. This can be required in cases where the tissue and / or bone is to be preserved to a greater extent and cutting is to be minimized. Such intraoperative conversion to a modular implant provides the surgeon with greater adjustability during a complex and unpredictable procedure. As will be appreciated, the surgeon prioritizes preserving remaining bone and minimizing the procedure time to reduce blood loss and anesthesia exposure. Monoblock implants are generally preferred for enhanced bone contact and reduced procedure time. However, modular implants are beneficial for maximizing bone preservation in femoral bone with more severe defects. Such decisions and evaluations can be made during the procedure, and thus the present instrument sets enable the surgeon to optimize the above considerations to ensure the health of the patient and to obtain the best results.
[0080] Figures 3A-D is a side view of the distal reamers and proximal reamers 13, 25b, 25a, and 26. Reference is made to Figure 3AThe shaft 16 includes one or more features 28 that facilitate attachment to a driving tool (not shown). Similarly, each proximal reamer 25b, 25a, 26 includes respective features 28 for direct or indirect connection to the driving tool. Each of the proximal reamers 25b, 25a, 26 includes an internal bore 41 sized to receive the shaft 16. Thus, each of the proximal reamers 25b, 25a, 26 can be coaxially mounted at the proximal end of the distal reamer 13 so as to form an axial stack or assembly. The proximal reamers assembled with the distal reamer can then be driven via the driving tool. Additionally, the present proximal reamers 25b, 25a, 26 can be used independently of and separate from the distal reamer 13 as desired by the surgeon. The cutting flutes 17, 27 extend the entire axial length of each respective cutting portion 60, 22 and are preferably helical between the axial ends. However, as will be appreciated, additional embodiments can include different configurations of cutting elements, including blades, ribs, grooves, etc.
[0081] Referring to Figure 4 The distal reamer 13 can be used followed by the proximal reamers 25a, 25b or 26 to prepare the femur 29 via sequential reaming of the femoral canal 29a to prepare an implant site cavity 30 suitable for receiving the implant 31. The implant 31 includes a stem 32, a neck 33 and a trunnion (head mount) 34 for mounting a head (as will be appreciated). Referring to Figure 5 The prepared cavity 30 can be adjusted via use of the proximal reamer 26 so as to receive, in the alternative, a modular implant 35. The implant 35 also includes a stem 32 that is insertable into the previously prepared femoral canal 29a while also including a modular shoulder 37 that is mountable onto a shaft pin 36. A neck 38 extends from the shoulder 37 and terminates at a head trunnion 39.
[0082] Referring to Figure 6 The initial phase of the surgical procedure to prepare the femur 29 to receive either of the implants 31 or 35 involves initial distal reaming using a plurality of distal reamers selected from the appropriate set 10, 11 or 12. Specifically, the selected distal reamers match the axial length, diameter and, particularly, the gauge of the implant 31 or 35 in axial length, diameter. Typically, three to six distal reamers 13 from any one set 10, 11 or 12 can be used during the initial distal reaming phase, which begins with the smallest diameter reamer and ends with the largest diameter reamer of the particular set / tray that matches the gauge of the implant 31 or 35. A drive mount 40 can be attached to the distal reamer shaft 16 for connection to a driving tool (not shown).
[0083] Referring to Figure 7Another phase of the procedure involves proximal reaming via a selected proximal reamer of the set 18, 19, or 20. If it is decided to continue with a monolithic implant 31, three to six (e.g., three to six) different diameter proximal reamers can be selected from the set 18 or 19 to work in concert to remove bone from the femoral canal 29a. In particular, the proximal reamer 25b is mounted to an axial coupling 40b, which is an extension of the shaft 16, which can be inserted and received within a bore 41 that extends axially within the proximal reamer 25. Figure 8 The assembled proximal and distal reamer combination is illustrated. If it is decided to continue with a modular implant 35, a proximal reamer 26 of the appropriate diameter can be used in place of the reamers 25a, 25b.
[0084] As noted, during the procedure, the surgeon will select a first distal reamer from the set of distal reamers, use the first distal reamer to expand the passageway, then withdraw the first distal reamer, then repeat the process with a second, larger diameter reamer. Reamers of further increasing diameter can be used until the surgeon achieves the desired diameter and profile of the passageway. Typically, a "cortical flutter" will indicate to the surgeon when the desired point of bone preparation has been reached. During the distal reaming phase, the surgeon is typically able to determine whether the in situ location for the stem of the surgical implant is a predictable location. That is, when the actual implant is inserted, the implant will be in the desired location within the femur, and thus, relative to the joint, as well. During the subsequent phase and during use, the stem will be axially stable. In this case, the surgeon will continue with the plan to use a first type of surgical implant. A monolithic surgical implant can be used as the first type of surgical implant, where all of the stem portion is defined by a single element.
[0085] As noted, in some cases, for patients with poor bone quality, the bone will not provide sufficient purchase or support for the stem and implant, and the surgeon can determine that another type of implant needs to be used. Returning to the procedure, if a first type of surgical implant (monolithic) is to be used, the procedure continues with the selection of a proximal reamer. Typically, a first diameter of the proximal reamer is selected. The reamer blade is disposed at the distal end, and the mounting location is disposed at the proximal end. As Figure 7 shown, the proximal reamer is mounted on a drive instrument, which is then inserted over the proximal end of the last distal reamer used. The proximal end of the last distal reamer is received in a bore within the proximal reamer. As Figure 8As shown, abutment of the proximal end of the distal reamer with the inner surface of the proximal end of the bore of the proximal reamer controls the distal positioning of the proximal reamer. Then, more material is removed from the proximal portion of the channel in the femur using the proximal reamer. Again, this process can be repeated using proximal reamers of increasing diameter from the kit to increase the diameter or profile of the proximal channel substantially.
[0086] Once preparation of the site has been completed, the first type of surgical implant can be inserted into the final position. If during or at the end of the distal reaming phase, the surgeon determines that the site in the patient is not stable enough for the first type of surgical implant, a different type can be substituted. However, the reamer kits provided for different types of implants are very different in length, profile along those lengths, and overall form. Thus, the surgeon can be faced with the need to open and use a greater number of reamer kits (particularly distal reamers) and / or to perform further preparation work in the femur for a different type of implant. These steps potentially increase the surgery time, cost, and complexity. In the present disclosure, the selective design across different sizes of different implant types, and the particularly careful design of the reamer kits, means that a given reamer kit is more versatile and there is better interchangeability between instrument types.
[0087] Reference is made to Figure 9A and Figure 9B Each of the implants 31, 35 includes a predefined gauge value corresponding to the diameter at the axial length position 42. The axial length position 42 is predetermined by the separation distance D from the central region / point of the head trunnion 34 in the axial direction. The implants 31 of different sizes and sizes are exemplarily overlaid such that the first size 43 includes the same axial position 42 of the gauge location relative to the implant 31 of the larger length 44 and the further size 45 of the longer length. The present kit is particularly adapted to provide a modular set of components including distal reamers and proximal reamers, wherein the distal and proximal components are interchangeable to accommodate different sizes 43, 44, and 45 while adhering to the predefined separation distance D and axial gauge position 42.
[0088] The modular configuration of the present instrument is exemplified in Figure 10 . In particular, the combination of each distal reamer and proximal reamer of the present concept includes a predefined gauge value G that is axially co-aligned with the same separation distance D from the head center point, as referenced to Figure 9A and Figure 9Bwith respect to implant 31. As shown, the gauge location G of distal reamers 13a, 13b and 13d (also mounting proximal reamer 25a) are co-aligned at the proximal end 14 of the respective cutting portion 60. Proximal reamer 25b (having a shorter axial length than reamer 25a) in combination with distal reamer 13a includes a gauge location G positioned at approximately the middle length of cutting portion 60. Further, according to another configuration and pairing of distal reamer 13c with proximal reamer 25b, the gauge location G is positioned towards the distal tip 15.
[0089] The proximal ends 24 of all assembled proximal reamers 25a, 25b (when paired with different sized distal reamers 13a, 13b, 13c, 13d) are all coaxially aligned at a predefined spacing distance A relative to the head center, which spacing distance also in part defines the spacing distance D of the gauge location. According to the present configuration, distance A is 50mm according to the particular configuration. Spacing distance B corresponds to the axial length of each respective cutting portion 22 of proximal reamer 25, and spacing C corresponds to the axial length of the cutting portion 60 of distal reamer 13b. With reference to Figure 10 , axial length H is the spacing distance between the proximal end 14 and the distal tip 15 of the cutting portion of distal reamer 13c; axial length K is the spacing distance between the proximal end 24 and the distal end 23 of the cutting portion of proximal reamer 13c; axial length I is the spacing distance between the proximal end 14 and the distal tip 15 of the cutting portion of distal reamer 13a; and axial length J is the spacing distance between the proximal end 14 and the distal tip 15 of the cutting portion of distal reamer 13d.
[0090] The present modular construction and interchangeability and compatibility of the reamers / implants is achieved via the common / uniform incremental of the respective axial lengths of the cutting portions of the various proximal and / or distal reamers described herein. Specifically and further with reference to Figure 10 , the difference between all of the following respective lengths: K and B; H and I; C and J, is equal. In other words, the total increase in length of the combined cutting portions of reamer 25a and 13d relative to the combined cutting portions of reamer 25a and 13b is equal to the total increase in length of the combined cutting portions of reamer 25a and 13b relative to the combined cutting portions of reamer 25a and 13a, which is equal to the total increase in length of the combined cutting portions of reamer 25b and 13a relative to the combined cutting portions of reamer 25b and 13c.
[0091] With increasing implant length, the length of the reamers located distal to the gauge position needs to be increased. However, since the tapered portion of the distal reamers extends proximal to the gauge position, it means that a common second type (proximal reamer) can be used for a first implant length, and also for a second, different implant length, thereby reducing the number of distal reamers needed.
[0092] As described, the present set of surgical instruments provides for intraoperative conversion between different implant types and / or sizes via the modular configuration of the respective axial length and diameter of the respective cutting portion, and the range of diameters within each set, thereby minimizing the need for bone protection and surgery time. Furthermore, the present set of surgical instruments minimizes the total number of cutting instruments forming the kit by utilizing a universal cutter suitable for surgical site preparation independent of implant type, via the array of different length and diameter profiles of the respective reaming instruments of each set. As noted, this is provided in part by a common gauge position G at the respective cutting portion of the cutting instruments to correspond to the gauge position of the implant. This is achieved via modular and / or common / uniform dimensional differences between the various distal reamers and / or proximal reamers. That is, the dimensions of the various distal reamer and / or proximal reamer sets differ from one another by the same / common qualitative modular amount. This provides for reamers having cutting portions of different lengths, while each / all of the sets include the same axial positioning G corresponding to the gauge position for each reamer in each / all of the sets. This interchangeability and modularity can be best exemplified in Figure 10 , via the pairing of proximal reamer 25a with each of the different distal reamers 13a, 13b. While not exemplified, if it is decided to change from a monolithic implant Figure 4 to a modular implant Figure 5 , proximal reamer 26 can be used instead of reamer 25a, for example at their respective pairing with distal reamers 13a, 13b or 13d.
[0093] The interchangeability according to the present concept is further exemplified in Figure 11 , which includes a monolithic reamer core set 50, which in turn includes sub-sets including short / standard proximal reamers 51 and long / extra long (XL) proximal reamers 52. The short / standard proximal reamers 51 (corresponding to reamer group 19) can be used in cooperation with either short distal reamers 53 or standard / long distal reamers 54 (corresponding to distal reamer sets 12, 10 and 11, respectively). The long / XL proximal reamers 52 are configured for use in cooperation with the standard / long distal reamers 54 and another XL distal reamer set 55.
[0094] These instruments also include a modular core reamer set 56, which specifically includes a modular proximal reamer sub-set 57 (corresponding to proximal reamer sub-set 20). As noted, the modular proximal reamer 57 differs from the monolithic proximal reamer 51, 52 in that the configuration of the cutting portion is cylindrical versus frusto-conical, respectively. The modular proximal reamer 57 is adapted for interchange and use with a series of different sized distal reamers, including the standard / long distal reamer 54, the XL distal reamer 55, the XXL distal reamer 58, and the XXXL distal reamer 59.
[0095] The various reamers of at least the first and second types herein are provided in a series of different lengths, which are considered from proximal to distal. Examples include three different lengths STD, Long, and X-Long for each of the different reamer sub-sets. The number of different lengths can be less than or greater than three, and in a number of other embodiments described, four different lengths are provided. These different length configurations can be provided for both the distal reamer and proximal reamer types. Thus, there can be a first type, length STD, a type, length Long, a type, length X-Long. There can also be a second type, length STD, a type, length Long, a type, length X-Long.
[0096] As noted, a gauge location is defined for each of the different types and different lengths STD, Long, X-Long, XXL, XXXL. In the present disclosure, the gauge location is provided at the same location for each of the different types of surgical implants. The gauge location is also provided at the same location for each of the different lengths STD, Long, X-Long, XXL, and XXXL. When aligned in the manner shown in Figure 9A , Figure 9B and Figure 10 the gauge locations can be defined at the same location. For example, by setting the gauge location at a given distance D (= distal) from the center of the head trunnion 34, the gauge locations can be at the same location. Between the gauge location and the proximal end of the stem segment, each of the different lengths (STD, Long, X-Long, etc.) can be equipped with a proximal stem segment that corresponds in diameter and / or other profile features across the different lengths (STD, Long, X-Long, etc.). Between the gauge location and the proximal end of the stem segment, each of the different types of surgical implants can be equipped with a proximal stem segment that corresponds in diameter and / or other profile features across the different lengths (STD, Long, X-Long, etc.).
[0097] Distal to the gauge position, the diameters and / or other profile characteristics of the different lengths can differ from one another. For example, each length can have an increased taper portion proximate the distal end, and / or each length can have a different length distal stem segment. Distal to the gauge position, two or more of the different lengths can have a common profile for the initial segment. Distal to the gauge position, each of the different lengths can have the same diameter and / or other profile characteristics for that length. In addition to the profile and / or proximal to distal extent differences described above, there can be other differences between the types of surgical implants and / or characteristics of the different reamer sleeve sets. For example, with respect to the implants, there can be the following differences: the lateral extent of the head segment and / or the inclination of the head segment and / or the profile of the head segment and / or the slots (including their profile and / or starting position and / or ending position and / or inclination), and / or whether the surgical implant is formed from a single element or from two or more elements that are connected together (including modular implants, where the stem part and the head part are connected together and are selected from a variety of different stem parts and / or head parts).
[0098] As described herein, in each case, the gauge position is at a fixed distance from the proximal end of the implant (the center of the head segment). The gauge position is also at a consistent distance from the proximal end of the mounting element of the second type of surgical instrument shown. This is slightly reduced compared to the proximal end of the head segment, by about 10 mm to 15 mm. The gauge position is also at a consistent distance from the proximal end of the mounting element of the first type of surgical instrument (shielded by and received within the inner bore of the second type). As noted, because the gauge position as described herein is constant for all surgical instruments and implants, the same distal reamer can be used for distal reaming of either implant type.
[0099] Importantly, by minimizing the proximal cylinder length, the taper and cutting area (tapered or cylindrical) of the proximal reamer is maximized. This can be 50 mm + / - 10%. The proximal cylinder length is the same across all lengths used. Thus, the present disclosure provides the surgeon with the possibility of fully changing to a second type of surgical implant after the distal reaming phase, without the need for further distal reaming or other preparation steps.
[0100] In terms of the overall required reamer set, the reamer design allows the surgeon to select, for example in pre-operative planning, the likely size of implant that will be required to fit the patient's femur. In use, whichever different type of surgical implant is ultimately used, the first reamer tray can be opened and the distal reamer used therein. The surgeon will decide throughout the procedure whether to continue with the planned first monolithic type of surgical implant or to switch to the second / modular type. If the first type is still used, only the proximal reamer of the second tray is opened and used; the further trays remain unopened and unused. If a change to the second / modular type is made, only the tray 20 with the proximal reamer 26 of the different type is opened and used; the second tray remains unopened and unused.
[0101] Figure 11 An example of how the reamers overlap their action in a more local sense but still have similar benefits can also be seen in the middle. Figure 11 Each box in the middle can represent a tray. For example, the St / L distal reamer tray and the XL distal reamer tray can both be used in the distal reaming stage and also allow the surgeon to easily choose between using a monolithic core tray as the first intended type of implant to be used or changing to a modular core tray if a second type of implant is required. If a monolithic core tray is to be used, the L / XL proximal reamer tray will be used. If a change to a modular core tray is made, the modular proximal reamer tray is used.
[0102] The overlap of the reamer configurations is local in the sense that the short distal reamer tray will result in the use of a monolithic core tray (further reaming can be an option to move to modular core tray use) but still only the Sh / St proximal reamer tray needs to be used to achieve the proximal reaming stage. Similarly, the XXL distal reamer tray will result in the use of a modular core tray but if the XXL distal reamer tray or the XXXL distal reamer tray is used for the distal reaming stage, only the modular proximal reamer tray will be required.
[0103] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the presently described subject matter belongs.
[0104] Where a numerical range is provided, for example, a concentration range, a percentage range or a ratio range, it is understood that every intervening value, as well as every sub-range between the upper and lower limit of that range and the upper and lower limit of that cited range is contemplated. The upper and lower limits of these smaller ranges can independently be included in the smaller ranges, and are also encompassed within the subject matter, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of the included limits are also included in the subject matter.
[0105] It should be understood that the terms "a" and "one," as used in the foregoing disclosure and claims, indicate "one or more" unless expressly specified otherwise. One of ordinary skill in the art will readily understand that the singular forms "a," "an," and "one" include plural referents unless the context clearly dictates otherwise. Thus, the terms "a," "an," and "one" are used interchangeably herein.
[0106] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as size, weight, reaction conditions, and so forth used in the specification and claims are to be understood as approximations based on the desired properties sought to be obtained by the present subject matter. Accordingly, unless otherwise indicated, the numerical parameters set forth in the following specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the present subject matter. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication is presented solely in terms of its proximity to the indicated value in a way that is not likely to affect the end result. Unless otherwise indicated, all percentages are by weight.
[0107] Throughout this application, the description of various embodiments uses "comprising." language; however, the applicant also contemplates other embodiments using the language "consisting essentially of" and "consisting of."
[0108] Having thus described the subject matter of the present disclosure, it is apparent that modifications and variations of the present subject matter can be made without departing from the spirit and scope thereof. Such modifications and variations are not to be regarded as a departure from the spirit and scope of the present subject matter, and all such modifications and variations are intended to be included within the scope of the claims filed below.
Claims
1. A surgical reamer kit comprising: a plurality of distal reamers, each distal reamer having a cutting portion extending between a distal tip and a proximal end, the distal reamers comprising 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 by a modular increment; a plurality of proximal reamers, each proximal reamer having a cutting portion extending between a distal end and a proximal end, the proximal reamers comprising at least a first group and a second group, the first group having different diameters and a common first axial length, the second group having different diameters and a common second axial length, the second axial length being greater than the first axial length of the proximal reamers by the modular increment; The distal reamers and the proximal reamers are constructed so that the proximal end of the first group of distal reamers can be positioned adjacent to the distal ends of the first group of proximal reamers and the second group of proximal reamers, and the distal end of the second group of proximal reamers can be positioned adjacent to the proximal ends of the first group of distal reamers and the second group of distal reamers, so that the corresponding combined axial lengths of the first group of proximal reamers plus the cutting portion of the first group of distal reamers, the second group of proximal reamers plus the cutting portion of the first group of distal reamers, and the second group of proximal reamers plus the cutting portion of the second group of distal reamers differ from each other by at least one of the modular increment values.
2. The kit according to claim 1, wherein: the diameter of the distal end of the cutting portion of at least one proximal reamer in the first set of proximal reamers being equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer in the first set of distal reamers; The diameter of the distal end of the cutting portion of at least one proximal reamer in the second set of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer in the first set of distal reamers; and The diameter of the distal end of the cutting portion of at least one proximal reamer in the second set of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer in the second set of distal reamers.
3. The kit of claim 1 or 2, wherein the distal reamer comprises an increase in diameter according to a tapered profile between the distal tip and the proximal end of each respective cutting portion.
4. The kit of any preceding claim, wherein the proximal reamer includes an increase in diameter according to a tapered profile between the distal and proximal ends of each respective cutting portion.
5. A kit according to any preceding claim, wherein the respective cutting portions comprise a slot extending at least axially and / or circumferentially along each respective cutting portion.
6. A kit according to any preceding claim, wherein the surgical reamer kit comprises at least three groups of distal reamers, the at least three groups of distal reamers comprising the first group, the second group and a third group, the third group having different diameters and a common axial length, the common axial length being greater than the axial length of the second group of distal reamers by the modular increment value.
7. A kit according to any preceding claim, wherein the surgical reamer kit comprises at least three groups of proximal reamers, the at least three groups of proximal reamers comprising the first group, the second group and a third group, the third group having different diameters and a common axial length, each of the reamers within the third group comprising a cutting portion having a uniform diameter extending axially between the distal end and the proximal end of each cutting portion.
8. The kit of claim 7, wherein the distal reamers further comprise fourth and fifth groups, each respective group having a plurality of reamers having different diameters and respective common axial lengths, wherein: the fourth set of reamers each including a cutting portion having an axial length greater than the axial length of the cutting portion of each of the reamers of the third set by the modular increment; and The reamers of the fifth set each include a cutting portion having an axial length that is greater than the axial length of the cutting portion of each of the reamers of the fourth set by the modular increment.
9. The kit according to claim 8, wherein the diameter of the distal end of the cutting portion of at least one proximal reamer in the third group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one distal reamer in the fourth group of distal reamers and / or the fifth group of distal reamers.
10. The kit according to claims 6 and 7, wherein the diameter of the distal end of the cutting portion of at least one reamer of the reamer of the third group of proximal reamers is equal to or approximately equal to the diameter of the proximal end of the cutting portion of at least one reamer of the reamer of the third group of distal reamers.
11. The kit of claim 7 , wherein the axial length of the cutting portion of each of the reamers of the third set of proximal reamers is equal to or approximately equal to the axial length of the cutting portion of the reamers of the second set of proximal reamers, wherein the diameter of the cutting portion of the second set of proximal reamers increases from the distal end to the proximal end of each respective cutting portion according to a tapered profile.
12. The kit of any preceding claim, wherein each of the sets of proximal and distal reamers comprises 2 to 16, 4 to 14, 4 to 12, or 8 to 12 reamers of different diameters.
13. A kit according to any preceding claim, wherein the diameter of the proximal end of the respective cutting portion of the distal reamer is in the range of 10 mm to 24 mm or 12 mm to 22 mm.
14. A kit according to any preceding claim, wherein the diameter of the distal end of the respective cutting portion of the proximal reamer is in the range of 10 mm to 24 mm or 12 mm to 22 mm.
15. A kit according to any preceding claim, wherein the reamers of the second set of proximal reamers have an axial length in the range of 80mm to 110mm, 85mm to 105mm or 90mm to 100mm.
16. The kit of any preceding claim, wherein the reamers of the first set of distal reamers have an axial length in the range of 125mm to 155mm, 130mm to 150mm, or 135mm to 145mm.
17. A kit according to any preceding claim, wherein the reamers of the first set of proximal reamers have an axial length in the range of 30mm to 60mm, 35mm to 55mm or 40mm to 50mm.
18. A kit according to any preceding claim, wherein the reamers of the second set of distal reamers have an axial length in the range of 175mm to 205mm, 180mm to 200mm or 185mm to 195mm.
19. A kit according to any preceding claim, wherein the modular increments are in the range 35mm to 65mm, 40mm to 60mm or 45mm to 55mm.
20. A surgical device for preparing a bone site to receive an implant, the surgical device comprising: A surgical reamer set according to any preceding claim; and a first implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, the implant having a predefined specification value corresponding to a diameter at a predefined axial location on the stem; At least one reamer of at least one of the first group of distal reamer drills and the second group of distal reamer drills includes a cutting portion having a specification value corresponding to a diameter at a predefined axial position on the cutting portion, the specification value being equal to the specification value of the implant to provide at least one specification-matched distal reamer.
21. The device of claim 20, wherein the predefined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion.
22. A device according to claim 20, wherein when the implant is positioned side by side to the matching distal reamer, and when the cutting portion and the rod are aligned parallel or nearly parallel and the distal tip of the rod is coaxially aligned with the distal tip of the cutting portion of the distal reamer, the axial spacing distance between the axial positioning at the center of the head and the proximal end of the cutting portion is a predefined set distance.
23. The apparatus according to claim 22, further comprising: a second implant having a stem, a neck, and a head or head mount connected to a shaft via the neck, the implant having a predefined specification value corresponding to a diameter at a predefined axial location on the stem; wherein at least one reamer of at least one of the first set of distal reamers and the second set of distal reamers includes a cutting portion having a gauge value corresponding to a diameter at a predefined axial location on the cutting portion, the gauge value being equal to the gauge value of the implant to provide at least one gauge-matched distal reamer; The axial length of the second implant is greater than that of the first implant, and the axial length of the distal reamer matching the second specification is greater than the axial length of the distal reamer matching the first specification.
24. The device of claim 23, wherein the predefined axial position on the cutting portion of the distal reamer is at the proximal end of the cutting portion.
25. A device according to claim 24, wherein when the implant is positioned side by side to at least one distal reamer of matching specifications, and when the cutting portion and the rod are aligned parallel or nearly parallel and the distal tip of the rod is coaxially aligned with the distal tip of the cutting portion of the distal reamer, the axial spacing distance between the axial positioning at the center of the head and the proximal end of the cutting portion is a predefined set distance.
26. A surgical method for preparing a surgical site and implanting an implant, the surgical method comprising: selecting a distal reamer from the first set of distal reamers and the second set of distal reamers according to claim 1 by matching predefined specification values of the implant to be implanted with predefined specification values of one of the first set of distal reamers and the second set of distal reamers; cutting material from a distal location at the patient's surgical site using a selected distal reamer of matching gauge; selecting a proximal reamer from one of the first group of proximal reamers and the second group of proximal reamers based on the axial length of the implant to be implanted and / or the specification value, such that a combined axial length of the cutting portions of the selected distal reamer and the selected proximal reamer is less than an axial length of the implant measured between a distal tip of the stem of the implant and a center point of the head of the implant; cutting material from a location proximal to the surgical site using the selected proximal reamer; and implanting the implant at the surgical site in the patient.
27. A method according to claim 26, when dependent on claim 7, wherein after the step of cutting material using the distal reamer, the state or condition of the material at the surgical site is evaluated, and one of the first group of proximal reamers, the second group of proximal reamers or the third group of proximal reamers is selected before the step of cutting material with the selected proximal reamer.
28. The method of claim 27, wherein: If the proximal reamer is selected from the first group or the second group, the implant to be implanted is a one-piece body implant; or If the proximal reamer is selected from the third group of proximal reamers, the implant is a modular implant having a head removably mountable to the stem; Such that the selected distal reamers are configured for sequential use to cut material at the surgical site with the first set of proximal reamers and either the second set of proximal reamers or the third set of proximal reamers.
