The present invention relates to implant trialling and in particular to trial implants for ball and socket type joints.
Prosthetic implants can be used to replace ball and socket type joints such as shoulder joints and hip joints. Many of these prosthetic implants have the general construction of a stem component, which is received in a long bone (such as the femur or humerus) to which a head component is attached and which provides an articulating surface. The head component can be received in a component having a concave articulating surface, sometimes referred to as a cup, so as to reconstitute the full ball and socket type joint.
During the surgical procedure it is often important accurately to place and position the prosthetic components. Typically cavities are formed in the patient's bones, for example using a broach or reamer, and parts of the patient's bones are resected during the surgical procedure, for example using a saw, in order to prepare the bones for implantation of the prosthetic joint. The preparation of the bones is not perfectly reliable and reproducible and so sometimes the actual positioning of the implants in the patient's prepared bones does not correspond to a planned position. Therefore, as part of the surgical procedure, trial components are often used to help assess intra-operatively the position of the implants and determine whether any changes to the implants or the bone preparation may be needed to bring the actual implant position closer to the planned position.
Implants are often provided in a variety of different sizes and the most appropriate size for an individual patient may not become clear until intra-operatively, when the bones have been prepared. It can therefore be necessary to provide a wide range of sizes of trial components to cover most scenarios. Further, when it is possible to vary a property of the implant, for example the off set, by combining different parts, then a variety of different implant parts can be needed for each different implant size. This can give rise to a large number of trial parts which need to be provided which can lead to confusion, reduced efficiency of the surgical procedure, increased inventory and increased manufacturing difficulty and costs.
An example of a trial implant for a ball and socket type joint with a stem component and an adjustable articulating component is described in U.S. Pat. No. 5,569,263. The articulating component is attached to a neck extending from a stem component and which has a plurality of grooves along its length. A locking mechanism can engage selectively with a one of the grooves to adjust the position of the articulating component relative to the stem to adjust the joint centre of rotation position.
Another adjustable trial implant us described in DE 102008030260. The trial implant has an articulating component which can detachably connected to a further component in different connecting positions relative to each other for example by using a screw thread mechanism.
Hence, it would be beneficial to make trialling for ball and socket type joints simpler.
Also, although ideally trial components would be used, in some instances surgeons may either elect not to use a trial component or the surgeon may want to do some further trialling from the implanted prosthetic component, for example because the position of the actual prosthetic component may differ from that of the trial component. Hence, the surgeon may want to do some trialling from the actual prosthetic component, either for efficiency of work flow or because the position of the prosthetic component is now fixed and therefore provides a more reliable datum. However, as the prosthetic component is not intended for trialling, use of the prosthetic component can render trialling less reliable.
Hence, it would be beneficial to make trialling for ball and socket type joints more reliable.
According to a first aspect of the invention, there is provided a trial implant system. The trial implant system can comprise a stem component having a neck including a free end. The neck can have a neck longitudinal axis. The system can include a first trial head having an articulating surface. The first trial head can include a bore having a bore longitudinal axis and which can receive the free end of the neck with the neck longitudinal axis and bore longitudinal axis coincident. The system can also include a first formation, or a first pair of formations, and a plurality of second formations, or a plurality of second pairs of formations, angularly disposed around the longitudinal axis. One of the first formation, or first pair of formations, and the plurality of second formations, or the plurality of second pairs of formations, is provided on the neck and the other is provided within the bore. Each of the second formations or second pairs of formations can matingly engage with the first formation or first pair of formations to limit the depth of insertion of the neck into the bore by a different amount.
Hence, the offset of an assembly of a trial head of a particular size and the stem component can be varied during trialling. Also, the mechanism by which the offset is adjustable allows the trial head easily to be removed from the stem component and so other trial heads can also be used with the same stem component having different offsets and/or different sizes thereby allowing a range of trialling sizes and offsets to be provided to cover much or all of the typical range of patient sizes but with a reduced number of trialling parts.
Preferably, the assembly can be adjusted without fully separating the trial head and stem. The first formation and plurality of second formations can be positioned on the neck and within the bore so as to be slidingly disengagable while an end portion of the free end of the neck is still located within the bore of the first trial head. The trial head can be rotatable about the free end of the neck while the free end of the neck is within the bore and with the first formation disengaged from the plurality of second formations
The first formation or plurality of second formations can terminate short of an end most face of the free end of the neck or a mouth of the bore of the trial head.
The first formation and plurality of second formations can terminate short of an end most face of the free end of the neck and a mouth of the bore of the trial head.
The first formation can terminate short of an end most face of the free end of the neck or a mouth of the bore of the trial head.
The first formation/pair of formations can be arranged to slidingly engage with each of the plurality of second formations/pairs of formations.
The first trial head can be detachable or removable from the stem component by translating along the longitudinal axis.
The first formation can comprise a lug and/or the second formations can comprise slots.
The first formation/pair of formations can be provided on the free end of the neck. The plurality of second formations/pairs of formations can be provided within the bore of the first trial head.
The first formation/pair of formations can be within the bore of the first trial head. The plurality of second formations/pairs of formations can be provided on the free end of the neck.
The first formation/pair of formations can comprise male formations and the second formations/pairs of formations can comprise female formations. The first pair of formations can comprise a pair of lugs or splines. Each of the second pairs of formations can comprises a pair of slots. Each pair of slots can have a different length.
Having the male formation or formations on the trial head can be preferred. This can help to prevent the trial head from being used with the prosthetic stem and so would prevent trialling off the prosthetic stem.
The first formation/pair of formations can comprise female formations and the second formations/pairs of formations can comprise male formations. The first pair of formations can comprise a pair of slots. Each of the second pairs of formations can comprise a pair of lugs or splines. Each pair of lugs or splines can have a different length and/or a different position along the longitudinal axis.
The trial implant system can include a plurality of trial heads. The plurality of trial heads can include heads of the same size but with differently configured first formations or pairs of formations and/or second formations or pairs of formations so that each head of the same size can provide a different set of adjustable offsets. The plurality of trial heads can include heads of different sizes and with first formations/pairs and/or second formations/pairs of formations providing the same set of adjustable offsets as the first trial head or a different set of adjustable offsets.
The trial implant system can further comprise a second trial head having an articulating surface. The second trial head can include a bore having a bore longitudinal axis and which can receive the free end of the neck with the neck longitudinal axis and bore longitudinal axis coincidental or aligned. The second trial head can be a different size to the first trial head. The second trial head can includes either a further first formation/pair of formations or a further plurality of second formations/pairs of formations angularly disposed around the longitudinal axis.
The trial implant system can further comprise a second trial head having an articulating surface. The second trial head can include a bore having a bore longitudinal axis and which can receive the free end of the neck with the neck longitudinal axis and bore longitudinal axis coincidental or aligned. The second trial head can be the same size as the first trial head. The second trial head can includes either a further first formation/pair of formations or a further plurality of second formations/pairs of formations angularly disposed around the longitudinal axis. The further first formation/pair of formations or the further second formations/pairs of formations can limit the depth of insertion of the neck into the bore by different amounts which differ from those of the first trial head.
The first trial head can include a plurality of markings. Each marking can correspond to a different offset associated with a respective one of the second formations/pairs of formations.
The plurality of markings can be provided on a side part of the articulating surface. The plurality of markings can be angularly disposed about the bore longitudinal axis.
The neck can include a plurality of markings, each marking corresponding to a different offset associated with a respective one of the second formations/pairs of formations. The plurality of markings can be disposed at different positions along the neck longitudinal axis.
The plurality of markings can be arranged to provide a scale. The scale can include graduations. The markings can include an indication of the magnitude of each offset and/or the sense of each offset.
Each second pair of formations can be arranged in diametric opposition around the longitudinal axis.
There can be at least three second formations or second pairs of formations, at least four pairs, more preferably at least five pairs and most preferably at least six pairs.
The stem component can comprises a trial stem or a part of a trial stem.
The stem component can comprise a part of a trial stem and can include an attachment mechanism for releasably attaching the part of the trial stem to a broach or a part of a broach. The system can also include a broach having one or more features of an attachment mechanism arranged to interact with the trial stem to releasably attach the stem component to the broach or a part of a broach.
The stem component can comprise a prosthetic stem or a part of a prosthetic.
The trial implant system can further comprise a protector which is removable attached to the free end of the neck. The first formation/pair of formations or the plurality of second formations/pairs of formations can be part of or on or provided by the protector.
The protector can include a side wall and the first formation/pair of formations can extend from the side wall on opposed sides.
The protector can includes an end wall and which can be arranged to cover the free end of the neck. The end wall can also be arranged to abut against an end face or surface of the free end of the neck.
A further aspect of the invention provides a method of trialling an implant. The method can comprise inserting a neck of a stem component within a bore of a trial head having an articulating surface and matingly engaging a first formation or first pair of formations with a first of a plurality of second formations or second pairs of formations to limit the depth of insertion of the neck into the bore by a first amount. The first of the second formations/pair of formations and the first formation/pair of formations can be disengaged. A second of the plurality of second formations/pairs of formations can be matingly engaging with the first formation/pair of formations to limit the depth of insertion of the neck into the bore by a second amount different to the first amount.
Hence, the offset of the implant can be adjusted by engaging the first formation/pair of formations with different ones of the plurality of second formations/pairs of formations so as to control the depth of insertion of the neck into the trial head by different amounts.
Preferably, the offset can be adjusted without fully separating the trial head and neck.
The trial head can be translated along a longitudinal axis of the bore in order to engage and/or disengage the first formation/pair and the second formations/pairs of formations.
Disengaging the first and second formations, or pairs of formations, can include removing the neck either partially or entirely from the bore of the trial head.
The method can further comprise rotating the first trial head about a longitudinal axis after disengaging and before matingly engaging the second of the second formations/pair of formations with the first formation/pair of formations.
A free end of the neck can be located within the bore of the trial head while the first trial head is rotated.
The method can further comprise removing the first trial head from the neck. The neck can then be inserted within a bore of a second trial head having a different size to the first trial head and matingly engaging either a further first formation/pair of formations with a first of the second formations/pair of formations or a first of a further plurality of second formations/pairs of formations with the first pair of formations. Hence, a further trial head having a different size can be used for trialling. The further trial head can provide the same or a different plurality of offsets to the previously used trial head.
A yet further aspect of the invention provides a method of trialling an implant. The method can include inserting a neck of a stem component within a first bore of a first trial head having an articulating surface and matingly engaging a first formation/pair of formations with a one of a plurality of second formations/pairs of formations to limit the depth of insertion of the neck into the first bore. The first trial can be removed from the neck. The neck of the stem can be inserted within a second bore of a second trial head having an articulating surface and having a different size to the first head and matingly engaging the first formation/pair of formations with said one or a further one of the plurality of second formations/pairs of formations to limit the depth of insertion of the neck into the bore. Hence, a further trial head having a different size can be used for trialling. The further trial head can provide the same or a different plurality of offsets to the previously used trial head.
Embodiments of the invention will now be described in detail, by way of example only, and with reference to the accompanying drawings, in which:
Some embodiments of the invention will now be described by way of examples to provide an overall understanding of the principles of the structure, operation and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Although the invention will be described below with reference to a hip implant, it will be appreciated that the invention can also be applied to other ball and socket type joint implants, such as a shoulder implant. In the following, “prosthesis” or “prosthetic” will be used to denote the actual implant finally placed by the surgeon to replace the patient's joint and “trial” will be used to denote for implants temporarily placed or used by the surgeon during the procedure for trialling purposes.
A first aspect of the invention aims to reduce the number of trial head components required to enable trialling of the different offsets and/or head sizes and/or taper sizes available. This is achieved by adapting the neck and trial head to allow the trial head to be attached at different depths to the neck and which correspond to the different offsets available of that head size. For example, for existing implant systems many different trial heads may be needed, for example up to twenty one to provide the different combinations of offset, taper size and head size needed to allow reliable trialling. However, this could be reduced to merely 7 different trial heads; one 28 mm trial head; two 36 mm trial heads; two 40 mm trial heads; and two 44 mm trial heads, with each trial head offering three different offsets. Fewer than seven different trial heads could be provided if more than three offsets are provided by the trial heads, particularly by the larger trial heads.
A second aspect of the invention aims to improve the reliability of trialling of ball and socket type joints, by allowing the surgeon to decide to use the prosthetic stem implant component for trialling rather than a trial stem component. A stem taper protector and specially adapted trial head component are used in which the trial head is configured to interact with the stem taper protector so that when assembled the prosthetic stem and trial head assembly has the same geometry as the prosthetic stem and a prosthetic head corresponding to the trial head. The stem taper protector allows the prosthetic stem to be used for trialling while protecting the stem taper from damage and/or being exposed to fluids from the surgical site which might otherwise decrease the reliability of the mating between the prosthesis stem taper and the prosthesis head component.
The first and second aspects of the invention can also be combined to provide offset adjustment and stem taper protection.
With reference to
As best illustrated in
The trial head can be made of any suitable material, such as metals, alloys or plastics, particularly polymers. Preferably, the trial head is made from a material unlikely to damage the articulating surface of a socket component, in case a user trialled against a prosthetic implant, such as an acetabular cup. For example, the trial head can be made from a glass filed polyaryletherketone (PAEK) such as that provided under the name AvaSpire (a trade mark which may be registered in some countries), polyetheretherketone (PEEK) or polyphenylsulfone (PPSU) such as that provided under the name Radel (a trade mark which may be registered in some countries). The trial head 100 is provided in a plurality of different sizes, with each size corresponding to the size of a corresponding prosthetic head. The size of the head can be defined by the diameter of the spherical part. For example, the trial and prosthetic heads can be provided in the sizes 28 mm, 36 mm, 40 mm and 44 mm.
In an alternate embodiment, the stem component 120 is provided as part of a stem trial implant rather than being a separate part which is attachable to a broach.
As best illustrated in
As also illustrated in
With reference to
As best illustrated in
The position of lower edges 244, 246 and/or the length of the lugs along the longitudinal axis 206 can be different. The position of the lower edges 244, 246 simply acts together with the position of the closed ends of the slots to control the depth of insertion of the neck 222 into bore 208.
It will be appreciated that the trial head 100, 200 has the same size as the corresponding prosthetic head that it is being used to trial for and hence presents the same articulating surface as the prosthetic head. Also the positions and lengths of the slots and lugs are arranged such that the trial assembly when configured to have a selected one of the offsets, e.g. +15 mm, will have the same geometry and present the articulating surface at the same position and orientation as the prosthetic stem and head assembly with the corresponding offset, in this example +15 mm.
In the first embodiment, markings indicating the offset associated with a particular one of the pairs of slots are on the lower surface 104 of the trial head. However, in other embodiments other marking positions can be used, for example to increase the ease with which the markings can be seen by a surgeon while using the trial assembly.
Use of the trial implant system in the context of a hip arthroplasty procedure will now be described. The system can include a plurality of trial heads 100 of different sizes so as to accommodate the typical range of patient sizes. The system can also include trial heads of the same size but each having a different plurality of slots so that a full range of offsets is available for any particular head size. Although the trial implant system can include a plurality of trial heads, during use of the system not all of the trial heads may be used and indeed only a one of the trial heads may be used.
The femoral head is resected and a broach or sequence of broaches is used to create a cavity in the superior part of the femur. The broach includes a broach part and a releasably attachable handle. Once the cavity has been formed in the femur to the appropriate size and depth for the planned stem prosthesis, the broach part is left in the cavity and the broach handle is removed. The trial stem component 200 is then attached to the broach using attachment formations 128 and 126 which mate with interacting features on the broach. If the acetabulum is also being replaced, then the acetabulum is prepared and typically a trial cup is placed in the prepared acetabulum. The surgeon the selects a trial 100 head having the same size, i.e. diameter, as the trial cup and attaches the trial head to the stem component 100 at a first offset by engaging lugs 134, 136 with a first pair of slots. The surgeon may then reduce the joint to see whether the first offset and/or trial head size is appropriate. If the first offset is not appropriate for whatever reason, then the surgeon can remove the trial head, rotate the trial head and re-attach the trial head to select a different offset. The surgeon can then reduce the joint again to see if the newly selected offset is more appropriate. If the surgeon wants to try an offset not supported by the current trial head, then the surgeon can select another trial head with the same size but providing a different plurality of offsets. In that case, the surgeon removes and discards the first trial head, selects the new trial head, of the same size, and attaches the new trial head using the pair of slots corresponding to the offset to be trialled. Additionally, or alternatively, the surgeon may determine that the trial head size is not appropriate and may replace the initial trial cup with a further trial cup having a different size, for example larger, and then select a trial head suitable for use with the further trial cup. The surgeon may vary the combinations of offset and head/cup size until they are satisfied with the selected components and may then replace the trial components with prosthetic components having the determined size and offset.
Hence, the first aspect invention reduces the complexity and/or number of trial implants that are supplied while still allowing reliable trialling over a full range of typical patient sizes by providing a simple offset adjustment mechanism which can also allow the number of trial heads supplied into the operating room to be reduced.
A second aspect of the invention will now be described with reference to
The trial head 310 generally has the form of a truncated sphere and presents an articulating surface 312 extending over upper and side portions of the trial head. The trial head also includes a planar circular under surface 314. An inner wall 316 defines a circular cylindrical bore 318 which extends into the interior of the trial head along a longitudinal axis 319 which passes through the centre of under surface 314 and the pole at the top of articulating surface 312. The trial head has the same size as the prosthetic head as its spherical part has the same diameter as the spherical part of the prosthetic head 380. The trial head can be made from any suitable biocompatible material including plastics or polymers.
The taper protector 330 has a first outer part 332 and a second inner part 340. Outer part 332 is made of a non-deformable rigid material. Outer part 332 has the form of a generally circular cylindrical cap with a side wall 333 and a circular end wall 335. An outer surface 337 of the side wall 333 is cylindrical and an inner surface 338 is slightly inclined and defines a tapered cavity 339 within the outer part 332. The outer part can be made from a suitable rigid or non-deformable biocompatible material such as a plastic or a metal or alloy. Various different engineering plastics can be used. Suitable plastics include silicone (especially with a high shore hardness), polyphenylsulfone (PPSU), such as that provided under the trade mark RADEL (which may be registered in some countries), Acetal and PEEK (Polyether Ether Ketone). Suitable metals and alloys include stainless steel, titanium and cobalt chromium alloys.
The inner part 340 is made from a deformable material and in particular can be made from a resiliently deformable material. The material of the inner part 340 is can be non-shedding and preferably will leave no-contamination or residue on the taper surfaces 326, 328. The inner part has the form of a generally tapered sleeve or tube, with open ends, and includes a tapering side wall 342. An outer surface 345 of the side wall 342 interfaces with the inner surface 338 of the outer part 332. An inner surface 346 of the side wall 342 interfaces with the outer surface 326 of the taper 324. The inner part 340 can be made from various deformable materials, such as silicone elastomer (with a low shore hardness), urethane, synthetic rubber, such as polyurethane rubber, and various foams. The inner part 340 has a lesser shore hardness than the outer part 330.
As best illustrated in
As also well illustrated in
With reference to
The articulating surface 382 of the prosthetic head 370 is identical to the articulating surface 312 of the trial head 310. A difference between the trial head 310 and prosthetic head 380 is that the cavity 318 in the trial head is adapted to compensate for the presence of the protector 330 on the taper while ensuring that the position of the trial articulating surface 312 relative to the prosthetic stem component 320 is identical to the position of the prosthetic articulating surface 382 to the prosthetic stem 320 in the prosthetic assembly. That is, is
The structural differences between the trial cavity 318 and prosthetic cavity are that the prosthetic cavity is tapered whereas the trial bore 318 is in the form of a right circular cylinder. Also, the trial bore 318 has a greater lateral dimension and a greater depth so as to accommodate the side walls and end wall of the protector 330. The trial articulating surface 312 should include at least all of the prosthetic articulating surface 382. The trial articulating surface 312 can be greater than the prosthetic articulating surface 382 but should not be lesser so as to ensure that a full range of motion corresponding to that available with the prosthetic component can be trialled. The trial and prosthetic articulating surfaces are sufficiently similar such that the trial head does not behave differently to the prosthetic head.
Hence, as best illustrated by comparing
Furthermore, the rigid outer walls 333 of the outer part 332 helps to retain the deformable part 340 within the protector 330 when the stem taper is initially introduced into the protector and enhances the interference fit by allowing the deformable part to be slightly compressed between the rigid taper surface 326 and the rigid side wall 333 of the outer part.
Hence, in use, the surgeon resects the proximal or superior part of the femur and creates a cavity in the resected femur using a broach or similar instrument. The prosthetic stem can then be placed in the cavity with the protector 330 in place and surrounding the side and end surfaces of the taper 324. The protector 330 can be provided pre-assembled to the prosthetic stem. In that case, the material of the protector is selected such that the protector does not degrade when sterilised or over time. The surgeon can then releasable attach trial heads of different sizes over the protector while being confident that the position of the trial articulating surface 312 will correspond to the position of the ultimately selected prosthetic head. After trialling, and when the surgeon has selected the appropriate head size, the protector 330 is removed from the taper 324 and the prosthetic head 370 is securely fastened to the prosthetic stem component 320 to form the prosthetic assembly 370 as illustrated in
With reference to
Taper protector 460 is similar to the taper protector 420 but has a generally cap-like construction and includes a tapering side wall 462 and a circular end wall 464. Taper protector 460 can be made from a non-deformable material, a deformable material or combinations thereof. Also, taper protector 460 can have a generally unity construction being made from a single part or may be made from two separate parts providing a deformable part and a non-deformable part, similar to taper protector 330. It is preferred if end wall 464 is made largely or entirely of a rigid material so as to provide a well-defined seating of the trial head 450 on the prosthetic stem 320 for the pile assembly 440 for the reasons discussed above.
With reference to
Taper protector 500 has a similar construction to taper protector 330 and includes a non-deformable outer part 502 and an inner, tapered deformable part 520. Outer part 502 is made from a rigid material and has a cap like construction and also includes a pair or lugs or splines 504, 506 extending from a side wall 508 and diametrically opposed to each other.
Hence, as illustrated in
It will be appreciated that the features of protectors 560, 580 & 600 can also be used on the trial stem of the first aspect of the invention.
Hence, the embodiment illustrated in
The third embodiment is similar to the first embodiment illustrated in
The stem 680 is similar to the stem illustrated in
In order to adjust the length of the assembly, the trail head is slid along the longitudinal axis, until the lugs 682, 684 have disengaged the slots and are clear of the under surface 666 of the trial head, as illustrated in
Allowing the length of the assembly to be changed without fully disengaging the trial head and stem makes it easier for the surgeon to adjust the length of the assembly in situ with the joint fully or partially reduced and without having to dislocate and then reduce the joint again. It is preferably to avoid repeatedly dislocating and/or reducing the joint during surgery so as to help avoid damage to the joint, such as to articulating surfaces and/or soft tissues structures, such as tendons and ligaments.
With reference to
With reference to
The diameter of the cylindrical end portion 746 of the stem is slightly less than the inner diameter of the cylindrical bore 725 of the trial head so that the free end 745 can be slidingly received within the open end space 732 and also within the remainder of the cylindrical bore 725.
In order to adjust the length of the assembly, the trail head is slid along the longitudinal axis, until the lugs 722, 724 have disengaged the slots and are clear of the top end surface 748 of the trial head, as illustrated in
Hence, this embodiment also allows the length of the assembly to be changed without fully disengaging the trial head 720 and stem 770. The surgeon can therefore adjust the length of the assembly in situ with the joint fully or partially reduced and without having to dislocate and then reduce the joint again, thereby reducing the chance of damage to the joint.
It will be appreciated that the same function can also be realised by modifying the slots rather than the lugs. For example the position of the open ends of the slots can be modified so that they terminate before the end most surface of the neck, similarly to the lugs shown in
It will be appreciated that the features of the different embodiments may be modified and/or used in different combinations to those of the embodiments specifically described above.
Number | Date | Country | Kind |
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1304835.0 | Mar 2013 | GB | national |
Number | Date | Country | |
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Parent | 14776072 | Sep 2015 | US |
Child | 16299387 | US |