ORTHOPAEDIC CEMENT REMOVAL TOOLS AND METHOD
20210338297 · 2021-11-04
Inventors
Cpc classification
A61B2017/320072
HUMAN NECESSITIES
A61B17/320068
HUMAN NECESSITIES
International classification
Abstract
A series of surgical tools (11, 21, 31, 41, 51, 61, 71, 81) have respective operative heads (16, 26, 36, 46, 56, 66, 76, 86 & 96) mounted adjacent a distal end of an elongate waveguide (12, 13, 14). The operative heads (16, 26, 36, 46, 56, 66, 76, 86 & 96) are used to remove PMMA bone cement (2, 5) from within a hollow bone (1), such as a femur (1), as part of a prosthesis revision operation, such as replacement of an artificial hip joint. Torsional-mode ultrasonic vibrations are transmitted along the waveguide (12, 13, 14) to the respective operative heads (16, 26, 36, 46, 56, 66, 76, 86 & 96), which are applied to the bone cement (2, 5), softening it and facilitating its removal. Elongate radial channels (18, 23, 28, 38) extend across cement-contacting faces of several of the surgical tools (11, 21, 31, 41, 71, 81), acting to focus and transmit the torsional-mode ultrasonic vibrations into adjacent cement (2, 5). In another tool (51), scalloped recesses (58, 59) in its cement-contact face have substantially the same effect, while in a further tool (61), a series of notches (65) along a distal edge (69) of the tool (61) have an analogous function. The operative heads (76, 86, 96) of certain tools (71, 81) can be embedded into a cement plug (5) then used to pull the plug (5) as a unit out of the bone (1).
Claims
1. A surgical tool for use in revision arthroplasty, adapted to be activated by torsional-mode ultrasonic vibrations, comprising an elongate waveguide adapted to transmit said ultrasonic vibrations to an operative head mounted adjacent a distal end of the elongate waveguide, wherein said operative head comprises a planar body extending transversely to a longitudinal axis of the elongate waveguide, and a distal face of said planar body comprises a plurality of concave recesses, each said concave recess being adapted to focus and project torsional-mode ultrasonic vibrations into bone cement and other materials in contact with said distal face.
2. The surgical tool as claimed in claim 1, wherein the planar body extends orthogonally to the longitudinal axis of the elongate waveguide.
3. The surgical tool as claimed in claim 1, wherein the planar body extends outwardly to all sides from the elongate waveguide.
4. The surgical tool as claimed in claim 1, wherein the concave recesses have an elongate form.
5. The surgical tool as claimed in claim 4, wherein the elongate concave recesses radiate outwardly across the distal face of the planar body from a point located in line with the longitudinal axis of the elongate waveguide.
6. (canceled)
7. The surgical tool as claimed in claim 1, wherein the distal face of the planar body comprises a distal projection located in line with the longitudinal axis of the elongate waveguide.
8. The surgical tool as claimed in claim 1, wherein a proximal face of the planar body also comprises a plurality of concave recesses, each said concave recess being adapted to focus and project torsional-mode ultrasonic vibrations into bone cement and other materials in contact with said proximal face.
9. The surgical tool as claimed in claim 8, wherein the concave recesses on the proximal face of the planar body are elongate.
10. The surgical tool as claimed in claim 9, wherein the elongate concave recesses radiate outwardly from a junction of the planar body with the elongate waveguide across the proximal face of the planar body.
11. The surgical tool as claimed in claim 1, wherein the planar body is substantially circular.
12. The surgical tool as claimed in claim 1, wherein the planar body comprises a plurality of shallow notches or recesses arranged around its circumference.
13. The surgical tool as claimed in claim 1, wherein the planar body is non-circular, extending further outwardly from the elongate waveguide in a first direction than it extends from the elongate waveguide in a second outwardly direction orthogonal to said first direction.
14. The surgical tool as claimed in claim 13, wherein the extent of the planar body in the second outwardly direction corresponds substantially to a diameter of the elongate waveguide.
15. The surgical tool as claimed in claim 1, wherein the surgical tool further comprises a second planar body, extending transversely to the longitudinal axis of the elongate waveguide from a point on the elongate waveguide proximal to the first planar body, said first and second planar bodies having substantially the same shape, size and alignment, but only the first planar body having concave recesses on its distal face.
16. A surgical tool for use in revision arthroplasty, adapted to be activated by torsional-mode ultrasonic vibrations, comprising an elongate waveguide adapted to transmit said ultrasonic vibrations to an operative head mounted adjacent a distal end of the elongate waveguide, wherein said operative head comprises a planar body extending transversely to a longitudinal axis of the elongate waveguide, and a proximal face of said planar body comprises a plurality of concave recesses, each said concave recess being adapted to focus and project torsional-mode ultrasonic vibrations into bone cement and other materials in contact with said proximal face.
17. The surgical tool as claimed in claim 16, wherein the planar body extends orthogonally to the longitudinal axis of the elongate waveguide.
18. The surgical tool as claimed in claim 16, wherein each concave recess on the proximal face of the planar body has an elongate form.
19. The surgical tool as claimed in claim 18, wherein the elongate concave recesses radiate outwardly from a junction of the planar body with the elongate waveguide across the proximal face of the planar body.
20. (canceled)
21. (canceled)
22. (canceled)
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. A method of removing a bone cement plug filling a bone cavity, following the removal of an implanted cemented prosthesis, comprising the steps of providing an ultrasonically-vibratable surgical tool having an operative head comprising at least one rotationally non-symmetrical planar body, driving said surgical tool into the bone cement plug while adjacent bulk bone cement is still softened as a result of said removal, twisting the operative head such that the at least one planar body of the operative head passes laterally into adjacent bulk bone cement, waiting until the bulk bone cement has re-hardened and the surgical tool is anchored into the bone cement, then manipulating the surgical tool to exert force on the bone cement plug and extract it substantially in one piece from the bone cavity.
28. The method of removing a bone cement plug as claimed in claim 27, wherein the operative head of the surgical tool is mounted adjacent a distal end of an elongate waveguide, the planar body extends transversely to a longitudinal axis of the elongate waveguide, and a distal face of said planar body includes a plurality of concave recesses, each said concave recess is adapted to focus and project torsional-mode ultrasonic vibrations into materials in contact with said distal face, wherein the planar body is non-circular, extending further outwardly from the elongate waveguide in a first direction than it extends from the elongate waveguide in a second outwardly direction orthogonal to said first direction wherein the extent of the planar body in said second outwardly direction corresponds substantially to a diameter of the elongate waveguide.
Description
[0054] Embodiments of the present invention will now be particularly described by way of example and with reference to the Figures of the accompanying drawings, in which:
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[0089] Referring now to the Figures and to
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[0093] When the first surgical tool 11 is activated by the torsional-mode ultrasonic vibrations, the round-bottomed channels 18 focus the vibrations and project the energy into material in contact with or closely adjacent to the distal face of the first operative head 16. Since torsional-mode vibrations comprise a twisting motion back and forth about the longitudinal axis of the waveguide, the effect of this operative head 16 will be greater towards its periphery.
[0094] The first surgical tool 11 is used to soften PMMA bone cement ahead (distally) of the tool 11, allowing it to be pushed into the solid cement. Softened cement will flow around a periphery of the first operative head 16 from a distal face to a proximal face, and it may be possible to remove this material by retracting the first surgical tool (proximally) before it re-solidifies. This tool 11 can also be used to broaden a hole formed into solid cement by pushing it into cement adjacent the hole, with the distal face partly contacting the cement and partly overlapping the hole.
[0095] The first surgical tool 11 is thus mainly used in clearing out solid cement forming the cement plug 5, distal to the location 4 of the implant within the medullary cavity of the bone 1.
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[0097] Eight first channels 23 and eight second channels 28 alternate around a distal face of the discoidal body 27, each extending outwardly from the central prong/peak 29. A notch 25 is formed in the circumference of the discoidal body 27 at an outer end of each first channel 23, while the second channels 28 each extend outwardly beyond the notches 25 to the circumference of the discoidal body 27. This produces a petal-like effect, as shown best in
[0098] Each of the first and second channels 23, 28 focuses torsional-mode ultrasonic vibrations into material in contact with or closely adjacent to the distal face of the second operative head 26, as for the first operative head 16, with the same effects. In this case, however, when the second surgical tool 21 is used, the presence of the notches 25 eases flow of softened cement through to a proximal side of the second operative head 26.
[0099] The second surgical tool 11 is thus suitable for the same procedural steps as the first, piercing into the cement plug 5 that fills the medullary cavity, distally of the location 4 of the removed implant, to aid its removal.
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[0101] However, sixteen additional round-bottomed channels 38 radiate across a proximal face of the discoidal body 37, between its circumference and the waveguide, as well as a short distance longitudinally along the distal section 14 of the waveguide (shown in broken lines in
[0102] The third surgical tool 31 can thus be used in an identical manner to the first surgical tool 11 as described above, or it can be drawn (proximally) upwardly along walls of a hole in the cement plug 5 or along the layers 2 of cement lining the internal walls 3 of the bone 1 itself, softening cement, scooping it up and drawing it out of the bone cavity.
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[0104] However, in the fourth operative head 46, the distal face 49 is featureless, and the circumference of the discoidal body 47 is bevelled distally.
[0105] The fourth surgical tool 41 is thus for use solely by being drawn (proximally) upwardly along cement forming walls of a previously formed hole, or along the layer 2 of cement lining the internal walls 3 of the bone 1, thus softening cement, scooping up the softened cement and drawing it out of the bone cavity.
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[0107] A distal face of the distal tip comprises nine scalloped recesses 58 around its periphery and a larger scalloped recess 59 located centrally. The fifth operative head 56 is dissected into three branches or lobes by three radial slots 55. The radial slots 55 extend almost to a centre of the distal face, reducing the central larger scalloped recess 59 to a three-armed, generally Y shaped feature, each arm of which extends outwardly to meet a trio of the nine scalloped recesses 58. The radial slots 55 also extend proximally through the terminal portion 57, becoming gradually shallower as they go, ultimately tapering out a short distance along the distal section 14 of the waveguide.
[0108] The scalloped recesses 58, 59 each focus and project the energy of torsional-mode ultrasonic vibrations into materials in contact with or closely adjacent to the distal face. The periphal nine scalloped recesses 58 will have a greater effect, since the amplitude of the torsional-mode vibrations will be greater towards the circumference of the distal face (narrow though it may be).
[0109] The radial slots 55 serve to allow cement softened by the ultrasonic vibrations to pass through the fifth operative head 56 to its proximal side; they hence generally correspond in function to the notches 25 of the second operative head 26 above, allowing for the different geometries of the respective operative heads 26, 56.
[0110] The fifth surgical tool 51 is hence also of most use as a piercing tool to drive into bulk cement to form holes, for example when narrow holes are required, or to create “pilot holes” for subsequent broadening by one of the other surgical tools 11, 21, 31, 41 described above.
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[0112] The sixth operative head 66 fans out laterally as it extends to its distal edge 69, as shown in
[0113] As best shown in
[0114] Additionally, although the sixth operative head 66 has a substantially constant length, as measured to its (apparently straight) distal edge 69 (see
[0115] As for the other operative heads described, the notches 65 and prongs 63 are not themselves intended as cutting/piercing features. Instead the notches 65 will serve to focus torsional-mode ultrasonic vibrations and project them immediately in front of the distal edge 69.
[0116] The sixth surgical tool 61 is often used in conjunction with the seventh surgical tool 71, of which the seventh operative head 76 is shown in
[0117] Although the operative head 76 is no longer fully circularly symmetrical, it can still safely be activated by torsional-mode ultrasonic vibrations, with both the channels 18 on the distal face and the additional channels 38 on the proximal face being capable of focussing and projecting the vibrations into adjacent material.
[0118] Similar tools can be produced with the channels 18, 38 present only on the distal or proximal face of their operative head, respectively; these are not shown for conciseness.
[0119] The seventh and sixth surgical tools 71, 61 may be used together to remove the cement layer 2 lining the internal walls 3 of the bone 1. The seventh surgical tool 71 is used to create grooves extending radially into and through the cement layer 2 to the wall 3, by presenting the distal face of the (ultrasonically activated) operative head 71 to an upper end of the cement layer 2 and pushing distally to pierce the cement, or by presenting the proximal face to a lower region of the cement layer 2 and drawing proximally to scoop cement away. The widths of the grooves are governed by the separation between the two straight sides 75 of the operative head 76. These grooves are preferably created extending longitudinally of the cement layers 2, dividing the cement layer into a series of vertical strips.
[0120] Next, the distal edge 69 of the sixth surgical tool 61 is presented to the bone/cement interface at a proximal/upper end of the cement layer 2, and activated, projecting ultrasonic vibrations down between the wall 3 of the bone 1 and the cement layer 2. This separates the cement layer 2 from the wall 3, allowing the (wedge-shaped) operative head 66 of the tool 61 to be passed further and further down/distally of the interior of the bone 1 and peeling entire strips of cement off the walls 3 at once. This is a very efficient way of removing the cement layer 2 from the walls 3. (Thorough removal of this cement can be particularly important when the prosthetic site has become infected).
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[0122] The eighth surgical tool 81 is used to extract the distal cement plug 5 from the bone cavity, once the cement layers 2 have been removed from the walls 3. The tool 81 is ultrasonically activated and offered up to the plug 5, the channels 18 on the distal face of the distal portion 86 focussing the ultrasonic energy into the cement ahead of the tool 81, softening the cement. The tool 81 can thus be pushed down into the cement of the plug 5. The proximal portion 96 is sufficient, when activated, to keep adjacent cement softened, even in the absence of focussing channels or recesses. Once both portions 86, 96 of the eighth operative head are well within the cement of the plug 5, the tool 81 is twisted about its longitudinal axis through about a right angle. This drives the distal 86 and proximal portions 96 laterally into the softened cement, anchoring the tool 81 securely in the plug 5 when the ultrasonic vibrations are turned off and the cement hardens again. Application of an impact extractor hammer to the tool 81 can then break substantial portions or the whole of the cement plug 5 free from the bone cavity in a single procedural step, saving much time and effort compared to removing the cement of the plug 5 step by step using piercing and scraping tools.
[0123] A kit of tools containing some or all of the tools 11, 21, 31, 41, 51, 61, 71, 81 described above, operatively connected as required to a source of torsional-mode ultrasonic vibrations, can thus be used to remove intramedullary PMMA cement during revision of a joint prosthesis, more effectively and efficiently than previous systems.
[0124] An exemplary method would proceed as follows. After removing the implant from a femur, the procedure starts from a proximal end of the femur. The cylindrical shell of cement lining the walls of the medullary cavity is approached by dividing it longitudinally, using a groove-forming tool (such as the seventh tool 71 of
[0125] Once these steps have been repeated sufficiently to remove the cement shell entirely and fully expose the distal cement plug, this can be removed either by repeated application of piercer and scraper tools or by embedding a tool such as the eighth tool 81 (shown in