SURGICAL INSTRUMENTS AND METHODS
20230056410 · 2023-02-23
Inventors
- Jason NAYLOR (Leeds-Yorkshire, GB)
- Stephen ROBINSON (Leeds-Yorkshire, GB)
- Charlie WESTON (Leeds-Yorkshire, GB)
- Caroline WITHER (Leeds-Yorkshire, GB)
Cpc classification
A61F2/30724
HUMAN NECESSITIES
A61F2002/30616
HUMAN NECESSITIES
A61F2002/4631
HUMAN NECESSITIES
A61F2002/30617
HUMAN NECESSITIES
A61F2002/4629
HUMAN NECESSITIES
A61F2/30723
HUMAN NECESSITIES
International classification
Abstract
A cement restrictor inserter instrument (130) comprises an inserter (131) having a handle (132) at a proximal end, a cement restrictor attachment formation (137) at a distal end for releasably attaching a cement restrictor (150), a shaft (136) extending from the proximal end to the distal end and a stop (138) on the shaft and between the proximal end and the distal end; and a body (140) having a shape corresponding to the shape of an orthopaedic prosthetic implant, a spacer (142), a visible depth guide feature (190) and a releasable attachment mechanism by which the body is releasably attachable to the shaft, and wherein the spacer is configured to position the visible depth guide feature at a fixed position relative to the inserter when the spacer abuts the stop corresponding to a target cement restrictor position when the visible depth guide feature is aligned with a feature of a bone of a patient in which the cement restrictor is to be inserted.
Claims
1. A cement restrictor inserter instrument comprising: an inserter having as handle at a proximal end, a cement restrictor attachment formation at a distal end for releasably attaching a cement restrictor, a shall extending from the proximal end to the distal end and a stop on the shalt and between the proximal end and the distal end; and a body having a shape corresponding to the shape an orthopaedic prosthetic implant a spacer, a visible depth guide feature and a releasable attachment mechanism by which the body is releasably attachable to the rod, and wherein the spacer is configured to position the visible depth guide feature at a fixed position relative to the inserter when the spacer abuts the stop corresponding to a target cement restrictor position when the visible depth guide feature is aligned with a feature of a bone of a patient in which the cement restrictor is to be inserted.
2. The cement restrictor inserter instrument as claimed in claim 1, wherein the releasable attachment mechanism includes a push fit or snap fit mechanism.
3. The cement restrictor inserter instrument as claimed in claim 1, wherein the stop includes an attachment formation and wherein the releasable attachment mechanism interacts with the attachment formation.
4. The cement restrictor inserter instrument as claimed in claim 3, wherein the attachment formation includes a circlip within a part of the stop and the releasable attachment mechanism of the body includes a groove arranged to receive the circlip.
5. The cement restrictor inserter instrument as claimed in claim 1, wherein the body defines an open channel or a closed channel extending, along a longitudinal axis of the body and configured to accept the shaft.
6. The cement restrictor inserter instrument as claimed in claim 1, wherein the releasable attachment mechanism permits rotation of the shaft relative to the body.
7. The cement restrictor inserter instrument as claimed in claim 1, wherein the cement restrictor attachment formation comprises a push fit formation.
8. The cement restrictor inserter instrument as claimed in claim 1, wherein the cement restrictor attachment formation comprises a screw thread.
9. The cement restrictor inserter instrument as claimed in claim 1, wherein the visible depth guide feature comprises a surface or an edge of a part of the body.
10. The cement restrictor inserter instrument as claimed in claim 1, wherein the visible depth guide future comprises a marking on a surface of a part of the body.
11. (canceled)
12. The cement restrictor inserter instrument as claimed in claim 1, wherein the orthopaedic prosthetic implant is a humeral stem, a femoral stem, femoral component of a knee or a tibial component.
13. The cement restrictor inserter instrument as claimed in claim 1, wherein the body has a size corresponding to the size of the orthopaedic prosthetic implant.
14. A kit of surgical instrument parts comprising: a cement restrictor inserter instrument comprising: an inserter having a handle at a proximal end, a cement res attachment formation at a distal end for releasably attaching a cement restrictor, a shaft extending from the proximal end to the distal end and a stop on the shaft and between the proximal end and the distal end; and a body having a shape corresponding to the shape of an orthopaedic prosthetic implant, a spacer, a visible depth guide feature and a releasable attachment mechanism by which the body is releasably attachable to the rod, and wherein the pacer is configured to, position the visible depth guide feature at a fixed position relative to the inserter when the spacer abuts the stop corresponding to tartlet cement restrictor position when the visible depth guide feature is aligned with a feature of a hone of a patient in which the cement restrictor is to be inserted; and a further body having a shape corresponding to the shape of the orthopaedic prosthetic implant, a further spacer, as further visible depth guide fetture and is further releasable attachment mechanism by which the further body is releasably attachable to the shaft, and wherein the further body has a different size to the body and corresponds to the shape of a different size ofthe orthopaedic prosthetic implant and wherein the further spacer has a different size to the spacer and is configured to position the further visible depth guide feature at is different fixed position relittive to the inserter when the further spacer abuts the stop corresponding to the target cement restrictor position when the further visible depth guide feature is aligned with the feature of the bone of the patient in which the cement restrictor is to be inserted.
15. A method of inserting a cement restrictor in a cavity in a patient, the method comprising: selecting a body having a shape corresponding to the shape of an orthopaedic prosthetic implant to be implanted in a cavity in a bone of a patient, wherein the body includes a visible depth guide feature; releasably attaching the body to a shaft of a cement restrictor inserter at a predetermined position; attaching a cement restrictor to a distal end of the shaft of the cement restrictor inserter; inserting the cement restrictor inserter with the body mounted thereon into the cavity to a depth determined by the visible depth guide feature being aligned with a feature of the bone of the patient.
16. The method as claimed in claim 15, further comprising; rotating the shall of the cement restrictor inserter relative to the body to detach the cement restrictor from the distal end of the rod; and withdrawing the cement restrictor inserter from the cavity.
17. The method as claimed in claim 15, wherein selecting the body further comprises selecting the body having a size corresponding to the size of the orthopaedic implant to be implanted in the cavity of the hone of the patient.
18. (canceled)
19. The method as claimed in claim 15, further comprising attaching a cement restrictor trial to the distal end of the shaft and inserting the cement restrictor inserter into the cavity to trial a size for the cement restrictor, after attaching the body and before attaching the cement restrictor.
20. (canceled)
21. (canceled)
22. The method as claimed in claim 15, wherein the visual depth guide is a surface or an edge of the body.
23. The method as claimed in claim 15, wherein the visual depth guide feature is a marking on a surface of the body.
24. (canceled)
25. The method as claimed in claim 15, wherein the prosthetic orthopaedic implant is one of: a femoral stem and wherein the feature of the bone of the patient is the neck resection of the femur: a tibial component and wherein the feature of the hone of the patient is the proximal resection of the tibia or a humeral stern and wherein the feature of the hone of the patient is the proximal resection of the humerus.
26. (canceled)
27. (canceled)
Description
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050] In the Figures of drawings, the same reference numerals are used to refer to refer to like parts unless indicated otherwise.
[0051] With reference to
[0052] Preferably, the cement mantel 120 has a thickness of a few millimetres, e.g.
[0053] approximately 2 mm, around the stem 114 which is generally centrally located within the intramedullary cavity of the femur. Also, preferably, the distance between a distalmost portion of the stem and the cement restrictor 124 is sufficient to allow the stem 114 to settle within the cement. However, it is not so great that excess cement is present within the intramedullary cavity, for example, to avoid difficulties in removing that cement, should revision surgery subsequently be required. In practice, the distance 124 is preferably approximately 20 mm.
[0054] The use of a cement restrictors is generally understood by a person of ordinary skill in the art, and cement restrictors can be used in other orthopaedic procedures in which some prosthetic component is cemented in place within a cavity of a patient's bone. As briefly discussed above, preferably, there is some finite distance between the cement restrictor and distal most part of the prosthetic implant component. However, the difficulty arises in trying to ensure that the cement restrictor 122 is placed at a depth within the cavity likely to give rise to the preferred separation 124 between the end of the prosthetic component and the cement restrictor. This is not something that can be achieved visually as the cement restrictor 122 is hidden from view when inserted into the cavity prior to cementation.
[0055]
[0056]
[0057] The stop 138 has a flared portion extending to a greater diameter than shaft 136 and provides an abutting shoulder portion 139. A circular cylindrical boss 152 extends toward the distal end and defines a groove or recess 154 therein. A C-clip or circlip 156 is located within circular groove 154. Circlip 156 is generally in the form of a C or split ring of a resilient material, such as a metal, for example stainless steel. The inserter part 131 of the cement restrictor inserter instrument illustrated in
[0058]
[0059] As best illustrated in
[0060] It is not essential that the dimensions of the body and corresponding prosthesis are identical. The body may be a simplified versions of the proximal part of the stem which has generally the same form or shape and which would be easier and cheaper to machine.
[0061] Hence, generally speaking, the body should be as close in geometry as is economically reasonable to the corresponding prosthesis. However, the body should not be longer or wider or thicker than the final broach or trial or cutting instrument used to form the femoral cavity otherwise the body would contact the interior walls of the femoral cavity prematurely and prior to the cement restrictor having been inserted to the desired depth.
[0062] A spacer part 164 extends from a proximal part of the body 166 and generally along a longitudinal axis 168 of the body which is generally parallel to the longitudinal axis of the shaft 136 of the inserter 131. As best illustrated in
[0063] The spacer element 164 has a generally circular cylindrical construction and defines a slightly tapered cavity 178 therein. As best illustrated in
[0064] Hence, the body 160 may be slid along shaft 136 of the inserter until the spacer 164 abuts the stop 138 to fix the position of the body relative to the remainder of the inserter. The releasable attachment mechanism prevents the body from being unintentionally removed from the shaft during handling.
[0065] As best illustrated in
[0066] In the illustrated embodiment, the visual depth guide feature 190 is in the form of a plurality of markings 194, 196, 198, each comprising a linear section. The linear sections are arranged generally perpendicularly to the direction of the neck axis of the corresponding stem component 114. Indeed, corresponding markings 119 can be seen on the prosthetic stem component 114 in
[0067] As described above, the body part 160, 140 of the inserter instrument 130 is releasably attachable to the inserter 131 by being slid along the shaft 136 and releasably attaching to the stop 138. In practice, a plurality of body parts each corresponding to a different size of prosthetic component may be provided. For example,
[0068] Generally speaking, the size of a stem is determined by its size in the medial-lateral direction. The length of the stem may also vary with the size of the stem such that a smaller stem will have a lesser length in the anterior-posterior direction than a larger sized stem. Therefore, the first body 140 corresponds to a prosthetic femoral stem having a smallest length in the inferior-superior direction, second body 160 corresponds to a second prosthetic femoral stem having a greater length in the inferior-superior direction than the first, and the third body 200 corresponds to a largest prosthetic femoral stem having a greatest length in the inferior-superior direction.
[0069] As the distance between the stop 138 and the distal end 134 of the inserter to which the cement restrictor is attached is fixed, the length of the spacer part of each body decreases as the size of the corresponding stem increases. In this way, the inserter 130 can be used to reliably position the cement restrictor 150 with the preferred separation from the distal-most point of the prosthetic implant by using the visual depth guide feature to be used to control the depth of insertion of the cement restrictor 150.
[0070] The first body 140 corresponds to a prosthetic stem with the shortest length in the inferior-superior direction and therefore has the longest spacer part 142 so as to position the visual depth guide features further down the shaft relative to the stop 138. The medium sized body 160 corresponds to a femoral stem having a greater length in the inferior-superior direction than the femoral stem corresponding to the first body 140 and therefore has a shorter spacer 164 so as to position the visual depth guide features 190 closer to the stop 138.
[0071] The third body 200 corresponds to a femoral stem having a greatest length in the inferior-superior direction and therefore has a shortest spacer 204 so as to position the visual depth guide feature 210 closest to the stop 138.
[0072] By varying the length of the spacer part along the longitudinal axis of the body, to compensate for the different lengths in the inferior-superior direction of the stems corresponding to the bodies, the visual depth guide features may be used to guide insertion of the cement restrictor 150 to a depth within the cavity corresponding to the desired separation 124 between the cement restrictor and the distal-most part of the prosthetic stem, when implanted.
[0073] With reference to
[0074] For example,
[0075] The femoral trial 400 has a correspondingly sized prosthetic femoral stem 114. However, the prosthetic femoral stem 114 has a slightly smaller size than the trial stem 400 in order to provide for the cement mantel 120 surrounding the prosthetic stem 114. Hence, once trialling has been completed at 304, the surgeon may determine the size of prosthetic femoral stem corresponding to the trial femoral stem 400.
[0076] As further illustrated in
[0077] At 308, the selected body 104 may be attached to the inserter 131 by being slid along the shaft and attached via the releasable attachment mechanism. As discussed above, the position of the body 140 along the longitudinal axis of the inserter is determined by abutment of the spacer part 142 with the stop 138.
[0078] A cement restrictor trial may then be attached to the distal end of the inserter instrument 130 at 310. The inserter instrument 130 may then be used to introduce the cement restrictor trial into the intramedullary cavity of the femur. Generally, the purpose of the cement restrictor trial is to gauge the appropriate diameter of the cement restrictor to be used. Hence, the surgeon may move the cement restrictor trial distally into the intramedullary cavity in order to gauge the diameter of the intramedullary cavity near the intended target position of the cement restrictor. As the exact positioning of the trial is not essential, this may be simply done by feel. Alternatively, or additionally, at 312, the surgeon may use the visual depth guide feature 144 on the anterior surface of the body by comparing the position of the marking corresponding to the previously planned position, e.g. marking 408, relative to the resection plane 113 of the femur.
[0079] At 314, the surgeon may determine whether the cement restrictor trial has the appropriate diameter for the target insertion depth. If not, then the method may return, as illustrated by flow line 316 back to step 310 and a different cement restrictor trial may be attached to the distal end of the introducer of a greater or lesser diameter. Hence, the method may repeat until a diameter of the cement restrictor has been successfully determined.
[0080] At 318, a cement restrictor having the diameter determined from the trialling is releasably attached to the distal end of the rod, after having removed the cement restrictor trial. In embodiments in which a threaded connection is used, then the cement restrictor is screwed on to the screw formation at the distal end 134 of the inserter instrument 130. In other embodiments, in which a push fit attachment mechanism is used, then the cement restrictor 150 may simply be pushed on to the distal end 134 of the inserter instrument 130. Then at 320, the cement restrictor 150 is introduced into the intramedullary cavity and the inserter 130 is used to insert the cement restrictor 150 into the intramedullary cavity. The shape of the body 140 helps to ensure that the longitudinal axis of the inserter 130 is generally aligned with central axis of the cavity rather than being tilted in the coronal plane. However, the dimensions of the body 140 are smaller than the dimensions of the trial stem 400 and therefore do not themselves limit the insertion depth of the cement restrictor. Rather, the shape of the body helps to provide visual context to the surgeon as to the correct depth of insertion of the cement restrictor. In particular, the visual depth guide features on the body 140 correspond to visual depth guide features 406 on the trial stem and also the visual depth guide features 119 on the prosthetic stem.
[0081] Hence, the surgeon may progress the inserter instrument into the intramedullary canal until the marking corresponding to the previously trialled marking, the central line in this example, is aligned with the resection plane 113 of a femur. The surgeon may now be confident that the cement restrictor 150 has been positioned at a target depth within the intramedullary canal of the femur which will have the appropriate degree of separation 124 from the distalmost part of the prosthetic stem 114 when inserted in the intramedullary canal at the corresponding position, as defined by the same middle line of the visual depth guide features 119 being aligned with the resection plane 113.
[0082] Hence, in embodiments in which a push-fit is used, the greater frictional force between the inner walls of the femur and the outer surface of the cement restrictor will overcome the frictional force of the push-fit interface between the distal end of the inserter and the cement restrictor and so the inserter instrument 130 may simply be withdrawn from the intramedullary cavity leaving the cement restrictor 150 secured in place at the target depth.
[0083] Alternatively, if a screw threaded attachment is used, then the handle 132 may be used to rotate the shaft 136 which may rotate relative to the body 140 thereby allowing the distal end 134 of the inserter to be detached from the cement restrictor 150. The circlip and groove releasable attachment mechanism permits rotation of the shaft 136 relative to the body thereby permitting disengagement of the screw thread attachment mechanism.
[0084] Hence, at 322, the inserter is detached from the cement restrictor, which is left in place at the target depth, as illustrated in
[0085] Consequently, cement may be introduced into the intramedullary canal and then the prosthetic stem 114 introduced and positioned with the central markings of its corresponding visual depth guide features aligned with the resection plane 113 of the femur.
[0086] With reference to
[0087] Similarly, a spacer 506 extends from a superior part of body 500 generally along the longitudinal axis of the body and defines a circular cylindrical cavity therein for receiving the shaft 136 of the inserter 131 in use. A proximal end of spacer 506 defines a shoulder 508 arranged to abut against the stop 138 of the inserter. However, in the illustrated embodiment, instead of using a circlip and groove, the releasable attachment mechanism 510 is in the form of a snap fit connector including four resilient tongues. The stop 138 of the inserter 131 defines a generally annular cavity therein and also a groove within an inner wall of the spacer configured to receive the protrusions at the free ends of the tongue, e.g. protrusion 512 of tongue 514. Hence, body 500 can be used generally similarly to the first embodiment described above. Again, the snap fit piece of attachment mechanism allows the shaft of the inserter to rotate relative to the body and therefore the cement restrictor inserter provided using this body can be used with cement restrictors attached via a push fit or screw fit connection.
[0088]
[0089] However, as best illustrated in
[0090] It will be appreciated that the use of cement restrictors is not limited to femoral stems and indeed may be used for other cemented orthopaedic implants having some stem like portion which extends into a cavity and which is not visible to a surgeon. The use of a body having the same shape and dimensions as a proximal part of the corresponding prosthetic implant is intended to help the surgeon to better understand and/or recollect whether the cement restrictor insertion depth is correct by using some visual depth guide feature to be compared with some part of the patient's bone but within the common context of the body and corresponding prosthetic implant. In many embodiments, the body is not itself used to control the depth of insertion. Rather, the body will have smaller dimensions than the cavity owing to the gap required between the walls of the cavity and the prosthetic implant to receive the cement cavity. The body may help with some centralisation of the inserter by partially filling the proximal part of the cavity. However, the shape and size of the body is more intended to provide visual and contextual feedback to the surgeon so that they can immediately understand that the body is at the correct position as the implant will be at that same position.
[0091] The relative position of the cement restrictor for the currently select body size is taken care of by the correct positioning of the body on the rod owing to the length of the spacer element and the position of the visual depth guide features on the body along an axis generally parallel to the longitudinal axis of the shaft of the inserter. Hence, the same inserter shaft can be used with multiple different bodies corresponding to different sized prosthetic implants with different sized stem lengths.
[0092] Therefore one aspect of the disclosure also relates to a kit of parts or surgical system including the inserter instrument, multiple bodies of different sizes and optionally multiple corresponding prosthetic implants of different sizes.
[0093] Other common orthopaedic implants which may use cemented stems, include humeral stems, both conventional and reverse shoulder, and also the tibial component and the femoral component of a knee prosthesis. Some femoral components include a cemented stem, especially those used in revision surgery.
[0094] For example, a body 650 having the shape and size of a corresponding prosthetic tibial component is illustrated in
[0095] The length of the spacer 662 in the direction of the longitudinal axis of the shaft 136 is selected such that when the free end of the spacer 662 abuts the stop 138 when mounted on the inserter 131, the cement restrictor would be located at the appropriate distance 124, within the tibial intramedullary cavity, from the distal most part of the stem of the corresponding prosthetic component when the underside or inferior surface 656 of the tray 652 is seated on the resected surface of the tibia (resulting from the proximal tibial cut). Hence, in this embodiment correct positioning of the cement restrictor is determined by the surgeon observing that the tibial tray part 652 is seated flush on the resected tibial surface, rather than comparing a marking on, or structural part of, the body with some part of the bone of the patient. Hence, in this embodiment, the under surface or inferior surface 656 of the tray part 652 provide the visual depth guide feature of the body 650 by which the insertion depth of the cement restrictor may be visually assessed by the surgeon.
[0096] By way of further example,
[0097] The length of the spacer 720 in the direction of the longitudinal axis of the shaft 136 is selected such that when the free end of the spacer 720 abuts the stop 138 when mounted on the inserter 131, the cement restrictor would be located at the appropriate distance 124, within the humeral intramedullary cavity, from the distal most part of the stem of the corresponding prosthetic component when the surface 718 of the wall 716 is aligned with the rim of the cavity formed in the proximal part of the humerus. Use of the cement restrictor inserter instrument 700 illustrated in
[0098] The body parts described above may be made from various materials and various plastics, especially polymeric plastics, are particularly suitable. For example, the body part may be made from Acetal or Polyoxymethylene (POM), Polyphenylsulphone (PPS), Polyetheretherketone (PEEK), Polyaryletherketone (PAEK) or similar and also filled versions of those plastics or similar.
[0099] Hence, it would be apparent that there are a number of different benefits provided by the various sets of instrumentation described herein and methods enabled thereby.
[0100] In this specification, example embodiments have been presented in terms of a selected set of details. However, a person of ordinary skill in the art would understand that many other example embodiments may be practiced which include a different selected set of these details. It is intended that the following claims cover all possible example embodiments.
[0101] The flowchart steps in the above Figures may be executed in other orders, unless a specific order is inherently required or explicitly stated. Also, those skilled in the art will recognize that while one example methods have been discussed, the material in this specification can be combined in a variety of ways to yield other examples as well, and are to be understood within a context provided by this detailed description.
[0102] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and described in detail. It should be understood, however, that other embodiments, beyond the particular embodiments described, are possible as well. All modifications, equivalents, and alternative embodiments falling within the scope of the appended claims are also envisaged.