PERFORATOR
20240000464 ยท 2024-01-04
Inventors
Cpc classification
International classification
Abstract
A perforator for cutting a hole in bone tissue is provided. The perforator comprises an anchor, a hole cutter configured to rotate around the anchor, and conversion means for converting rotational motion of the hole cutter around the anchor into linear motion of the hole cutter towards the material to be cut. The invention is usable to cut holes in a wide variety of materials, in particular for a perforator for cutting a hole in a skull of a human or animal. A kit of parts and a method of cutting a hole are also provided.
Claims
1. A perforator for cutting a hole in bone tissue, comprising: an anchor configured to be secured to a material to be cut; and a hole cutter configured to rotate around the anchor and cut the material, wherein the hole cutter is configured to engage the anchor via conversion means configured to convert rotational motion of the hole cutter around the anchor into linear motion of the hole cutter towards the material.
2. A perforator according to claim 1, wherein the conversion means is configured to convert rotational motion of the hole cutter around the anchor into linear motion of the hole cutter towards the material only upon there being a sufficient counterforce, away from the material, acting on the anchor.
3. A perforator according to claim 1, wherein the hole cutter comprises at least one cutting edge at a radius r from a central axis of the anchor, so that conversion of rotational motion of the hole cutter around the anchor urges the hole cutter towards the material causing the hole cutter to cut a hole with a diameter d=2r.
4. A perforator according to claim 1, wherein the conversion means comprises a first portion on the anchor and a second portion on the hole cutter.
5. A perforator according to claim 4, wherein the conversion means comprises a first thread on the anchor, configured to engage a second thread on the hole cutter.
6. A perforator according to claim 5, wherein the threads have a thread pitch of between about 0.3 mm and about 2.0 mm.
7. A perforator according to claim 1, wherein the anchor, at a distal end, comprises a screw tip for securing to the material to be cut.
8. A perforator according to claim 7, wherein the anchor comprises an abutment surface adjacent a proximal end of the screw tip.
9. A perforator according to claim 1, wherein the hole cutter comprises a cutting head and a shaft, wherein the cutting head is removable from the shaft.
10. A perforator according to claim 1, wherein the hole cutter comprises a cutter drive portion.
11. A perforator according to claim 1, wherein the anchor comprises an anchor drive surface.
12. A perforator according to a claim 1, further comprising a drive tool configured to engage at least one of: the hole cutter; the anchor.
13. A perforator according to claim 12, wherein the drive tool is configured to engage the anchor, the anchor comprises an anchor drive surface, and the drive tool comprises first tool drive portion configured to engage the anchor drive surface; or wherein the drive tool is configured to engage the hole cutter, the hole cutter comprises a cutter drive portion, and the drive tool comprises a second tool drive portion configured to engage the cutter drive portion.
14. A perforator according to claim 1, in which: the anchor is connected to an anchor handle, and/or the hole cutter is connected to a cutter handle.
15. A kit of parts for cutting a hole in bone tissue, the kit of parts comprising: an anchor configured to be secured to a material to be cut; and a hole cutter configured to cut the material and engage the anchor via conversion means, in which the conversion means is configured to convert rotational motion of the hole cutter around the anchor into linear motion of the hole cutter towards the material.
16. A kit of parts according to claim 15, wherein the anchor is a self-drilling screw comprising a self-drilling screw tip at a distal end, and a shank extending from the screw tip to a proximal end, wherein a portion of the shank comprises a first thread; and wherein the hole cutter comprises at least one cutting edge at a distal end and, on an inner surface of the hole cutter, a second thread for engaging with the first thread.
17. A kit of parts according to claim 15, comprising a drive tool, wherein the drive tool is configured to engage at least one of: the hole cutter; the anchor.
18. A kit of parts according to claim 17, wherein the drive tool comprises a first tool drive portion configured to engage an anchor drive surface on the anchor, and/or a second tool drive portion configured to engage a cutter drive portion on the hole cutter.
19. A method of cutting a hole, the method comprising the steps of: securing an anchor to a material to be cut; engaging a hole cutter with the anchor via conversion means for converting rotational motion of the hole cutter around the anchor into linear motion of the hole cutter towards the material; and rotating the hole cutter around the anchor, so that the conversion means converts the rotational motion of the hole cutter into linear motion that urges the hole cutter into the material.
20. A method according to claim 19, in which the step of securing the anchor to the material to be cut comprises the step of screwing a screw tip of the anchor into the material to be cut.
21. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0101] Specific embodiments of the invention will now be described with reference to the figures, in which:
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DETAILED DESCRIPTION OF THE INVENTION
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[0120] In
[0121] In use, the perforator 10 must be connected to a manual or, more commonly, an electric drill. The perforator 10 is not a standalone apparatus for cutting a hole. The distal end of the perforator 10 terminates in the distal tip 20 of the inner drill head 12, which contacts bone in use, and is shown at the bottom of
[0122] The inner drill head 12 is movable along the rotational axis A between two positions: a distal position, in which the inner drill head 12 is not connected to the drive shaft 16, and a proximal cutting position, in which the inner drill head 12 is connected to the drive shaft 16. The inner drill head is biased away from the drive shaft 16 and into the distal position by a spring 18, so that the inner drill head only moves into the proximal cutting position when the distal tip 20 of the inner drill head 12 is pressed against a surface, such as a bone. The force with which the distal tip 20 has to be pressed against the surface to overcome the biasing force of the spring 18 is determined by the spring constant of the spring 18 and the axial separation between the distal position and the proximal cutting position.
[0123] When no pressure is applied to the distal tip 20 of the inner drill head 12, the inner drill head 12 and the drive shaft 16 are disconnected, and neither of the inner drill head 12 and the outer chipping head 14 rotates even when the drive shaft 16 is rotating. As such, the user must exert a force in a direction towards the surface of the material to be cut so that the inner drill head 12 is pressed against the surface with sufficient force to overcome the biasing force of the spring. A cylindrical housing 22 is arranged coaxially around the outer chipping head 14.
[0124] As soon as the distal tip 20 of the inner drill head 12 perforates the bone (for example the inner surface of the cranium), the force applied to the tip of the inner drill head 12 by the bone is greatly reduced, so that it is exceeded by the force exerted by the biasing spring 18 on the inner drill head 12, so that the biasing spring 18 urges the inner drill head 12 forward. As the biasing spring 18 urges the inner drill head 12 into its distal position, both the inner and outer cutting heads should cease to rotate immediately to prevent damage to the dura mater.
[0125] The present inventors have found, however, that in the prior art designs it cannot be guaranteed that the inner cutting head does not damage the dura mater. This is in part because the clutch may not disengage in time, in part because the inner drill head 12 comprises sharp projections, which are urged forward when the perforator penetrates the bone, and in part because the user must exert a force towards the material to be cut for the perforator to function. This risk is heightened because of the likelihood that the user must be pressing the perforator towards the skull at the moment that the cranium is perforated.
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[0127] In this preferred embodiment, as shown in
[0128] Distally, the apparatus 200 terminates in a distal anchor tip 212 configured to engage the material to be cut, shown at the bottom of
[0129] The drive tool 210 is separable from the rest of the apparatus 200, but in
[0130] In a first delivery state for securing the anchor, the drive tool 210 may be engaged with the anchor 202 as shown in
[0131] As described below, the drive tool 210 is a multifunctional drive tool for engaging the anchor 202 as shown in
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[0133] As shown in
[0134] The length of the screw tip 300 and the pitch of the thread of the screw tip 300 are selected according to the thickness and hardness of the material to be cut. If the apparatus 200 is a perforator for cutting a hole in a skull, the screw tip may be between 3 mm and 6 mm long. The pitch of the thread of the screw tip 300 determines the linear movement along longitudinal axis A, towards a material, per rotation of the anchor 202. The thread of the screw tip 300 is designed such that it can resist a traction force acting on the anchor 202.
[0135] Proximally, the screw tip 300 is connected to a shank 302, the shank 302 having at a distal end an abutment surface 303. The abutment surface 303 has a larger diameter than the screw tip 300, so that when the screw tip is fully screwed into a material to be cut, the abutment surface abuts the material to prevent further travel and indicate that the anchor is secured. The screw tip 300 is connected to the shank 302 via the abutment surface 303.
[0136] The shank 302 comprises a first thread 304, which is a male thread. The first thread 304 is part of a conversion means for engaging the anchor 202 with the hole cutter 204. The thread pitch of the threads in the conversion means determines the distance of a linear movement of the hole cutter 204 along longitudinal axis A, towards a material, per rotation of the hole cutter 204 around the anchor 202.
[0137] Proximally, the anchor 202 has an elongated pilot pin 306. At the proximal end of the pilot pin 306, the anchor 202 comprises an anchor drive surface configured to be engaged by the drive tool 210, and an indentation 310. The anchor drive surface is provided on a flat projection 308 extending from the proximal end of the anchor 202, so that a corresponding anchor drive surface on the drive tool 210 can abut the anchor drive surface and drive rotation of the anchor 202. In order to engage the flat projection 308, the anchor drive surface on the drive tool 210 may be two walls defining a slot sized to receive the projection 308.
[0138] When the projection 308 providing the anchor drive surface is engaged by the drive tool 210, rotational motion of the drive tool 210 is transmitted to the anchor 202 so that the screw tip 300 can be screwed into the material to be cut. The elongation of the pilot pin 306 allows for secure positioning and screwing in of the anchor 202 on uneven or slanted surfaces. When the screw tip 300 is fully screwed into the material to be cut, the abutment surface 303 abuts the material to be cut, and the anchor 202 is securely attached to the material.
[0139] The indentation 310 in the proximal end of the pilot pin 306 is configured to be engaged by a clamping means of the drive tool 210, so as to secure the drive tool 210 safely to the anchor 202. This also allows for easy removal of the drive tool 210 from the anchor 202 once the anchor 202 is secured to the material to be cut.
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[0141] The outer diameter of the cutting head 206 is varied so that the cutting head has a conical profile 402 both internally and externally, so as to allow the hole cutter 204 to be easily withdrawn from the skull once a bone flap 404 has been separated from the rest of the skull. The conical profile 402 also allows for the bone flap 404 to be more easily reinserted into the hole cut in a skull.
[0142] A typical skull may have a thickness of up to 10 mm, and the cutting head 206 is designed so as to allow a hole to be cut into a skull of up to 10 mm thickness. The diameter of the hole that will be cut by the apparatus is determined by the outer diameter of the cutting head 206 at the cutting edges 400. For use as a perforator, the diameter may be around 6 mm, 8 mm, or 11 mm, or any other suitable diameter. The suitable diameter may depend on the type of neural surgery required.
[0143] Due to the properties of the cutting edges 400 and the cone-shaped outer profile of the cutting head 206, the cutting edges 400 cut around the perimeter of a bone flap 404 or bone disc. As the bone flap 404 is secured to the anchor 202 by the screw tip 300, the bone flap 404 is maintained within the cutting head 206 both during and after cutting. The diameter of the cutting edges 400 is substantially equivalent to the diameter of the bone flap 404 or bone disc being cut.
[0144] Such a bone flap 404 or bone disc may be reattached to the skull so as to close the hole cut by the apparatus 200. Reattaching the bone flap 404 or bone disc to the skull may allow for improved healing, or a reduced risk of infection, in particular when compared with to commonly used artificial calcium phosphate plugs.
[0145] Although a specific embodiment of a cutting head 206 has been described, many other embodiments could achieve the required function of cutting a material to be cut, and cutting heads for use in the present invention are not limited to the depicted embodiment.
[0146] In the preferred embodiment shown, the cutting head 206 is separable from the shaft 208 of the hole cutter 204, but these components may optionally be formed as one unit.
[0147] At a proximal end, the cutting head 206 comprises a first attachment 406 configured to engage the shaft 208 so as to attach the cutting head 206 to the shaft 208 to form the hole cutter 204.
[0148] As shown in the cross-section in
[0149] The first thread 304 and the second thread 502 are cooperating parts of a conversion means. When the apparatus is assembled, the first thread 304 engages the second thread 502, so that rotational motion of the hole cutter 204 around the anchor 202 causes the second thread to move down the first thread, so that the cutting head 206 moves in a distal direction relative to the anchor 202.
[0150] When the anchor 202 is secured to the material to be cut (bone tissue, typically forming part of a skull), the cooperation of the first thread 304 and the second thread 502 means that rotational motion of the hole cutter 204 around the anchor 202 results in a traction force on the anchor 202 and linear motion of the hole cutter 204 along the longitudinal axis A towards the material. In other words, the two engaged threads 304, 502 act as a conversion means that converts rotational motion of the hole cutter around the anchor into linear motion that urges the rotating hole cutter 204 toward and into the material to be cut.
[0151] The first attachment 406 may be an injection-moulded part, which allows for it to be produced cost-effectively. Injection-moulding of the first attachment 406 may result in the apparatus 200 being suitable for single use only, which may help to ensure that the apparatus 200 is sterile when used.
[0152] As shown in
[0153] A clamping means of the drive tool 210 may be configured to clamp the cutter drive portion 504 and/or the grooves 505 in order to transmit rotational motion of the drive tool 210 to the hole cutter 204. In the illustrated embodiment, the outer diameter of the shaft 208 is tapered from a distal end to a proximal end. As such, the drive tool 210 can fit around the circumference of the shaft 208, and be moved in a proximal direction relative to the shaft 208, so as to engage the grooves 505 via the open distal end of the grooves 505.
[0154] As shown in
[0155] As mentioned above, the drive tool 210 is separable from the apparatus 200 and is advantageously designed to engage with the anchor 202 in order to screw the anchor into the material to be cut, and also to engage with the hole cutter 204, in order to easily rotate the hole cutter 204 around the anchor. For engagement with the proximal end of the anchor 202, the drive tool 210 comprises, at a bottom surface, a projection 600 for engaging a proximal end of the anchor 202. The projection 600 comprises a central elongate slot 602 corresponding to the projection 308 carrying the anchor drive surface. The slot 602 is sized to receive the projection 308 of the anchor 202 providing the anchor drive surface so as to transmit rotational motion of the drive tool 210 to the anchor 202. This means that the anchor 202 can be secured to the material to be cut by positioning the screw tip 300 at the desired point on e.g. a skull, engaging the drive tool 210 with the proximal end of the anchor 202, and rotating the drive tool to screw the anchor 202 into the skull until the abutment surface 303 contacts the skull.
[0156] Inside the slot 602, the drive tool 210 may further comprise a clamping means (not shown) such as a spring clip, which may be configured to engage indentation 310 of the anchor 202. In this manner, the drive tool 210 may be secured to the anchor 202 so as to transmit rotational motion, but may also be easily disengaged from the anchor 202, e.g. by pulling on the drive tool 210 in a proximal direction, once the anchor 202 is secured to the material to be cut.
[0157] The slot 602 of the projection 600 may further comprise a central circular cavity 603. The slot 602 splits the distal end of the projection 600 such that it comprises two prongs 605 configured to engage either side of the projection 308 of the anchor. This can further be seen in
[0158] As shown in
[0159] The drive tool 210 is configured to engage the hole cutter 204 by placing the open-ended spanner around the shaft 208 so that the shaft 208 is placed within the recess 604. By moving the drive tool 210 axially, in a proximal direction, the drive tool 210 engages the grooves 505 of the cutter drive portion 504. The projections 608 on the drive tool 210 engage the grooves 505 on the anchor 202, and the spring clip 606 clamps the drive tool 210 in place on the hole cutter 204.
[0160] In this way, the drive tool 210 is secured in position relative to the hole cutter 204 so as to allow the hole cutter to be rotated around the anchor by rotating the drive tool 210. However, because the clamping force of the spring clips 606 is relatively low, the drive tool 210 disengages from the cutter drive portion 504 easily if an axial force in a direction towards the material to be cut is exerted on the drive tool 210, as the projections 608 slip out of the open distal ends of the grooves 505.
[0161] The drive tool 210 further comprises an opening 610 extending through the drive tool so as to provide a handle or grip for a user to engage, as further shown in
[0162] As such, the cutter drive portion 504 and the drive tool 210 prevent the user from exerting a force in the direction of the material to be cut at the same time as cutting the material. Therefore, any risk of damage to anything underlying the material to be cut may be avoided.
[0163] When the perforator is used to cut a hole in a skull, there may advantageously be no risk of damage to the dura mater.
[0164] In an alternative embodiment of the apparatus 200 which is instead adapted for another purpose, such as to cut a hole in plasterboard, there may be no risk of damage to an underlying electric cable or pipe.
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[0166] To secure the apparatus 200 to the skull 700, the drive tool 210, which is shown in
[0167] The drive tool 210 is then removed from the proximal end of the anchor 202 and the recess 604 of the drive tool 210 is pushed into engagement with the cutter drive portion 504 of the shaft 208. As shown in
[0168] As the drive tool 210 is rotated around the anchor 202 causing the hole cutter 204 to rotate along with the drive tool 210, the interaction of the first thread 304 and the second thread 502 cause the rotational motion of hole cutter 204 around the anchor 202 to be converted into a linear motion of the hole cutter 204 towards the skull 700. This causes the cutting edges 400 to be gradually pressed into the skull, and to cut the skin and bone tissue. The linear motion of the hole cutter 204 towards the skull also causes traction on the anchor 202.
[0169] As the engaged screw threads 304, 502 convert rotational motion into a force that urges the cutting head 206 through the skull 700, there is no need for the user to press the apparatus 200 into the skull 700 while cutting. In fact, any attempt to press the apparatus 200 towards the skull will cause the drive tool 210 to disengage from the cutter drive portion 504. This advantageously ensures that the skull is cut gradually and gently, with greatly reduced risk of accidental damage to the dura mater.
[0170] When the cutting head 206 finishes cutting through the skull 700, the bone flap 404 remains attached to the anchor 202, and the bone flap 404 can be easily removed to leave a circular hole. The bone flap 404 may be used to seal the hole cut into the skull 700, which may advantageously result in improved healing.
[0171] An alternative embodiment of the apparatus of the present invention is shown in
[0172] Anchor handle 1002 is connected to anchor 202, so that rotational motion of handle 1002 is transmitted to anchor 202. This facilitates securing of the anchor 202 to a material to be cut, as the user can screw the anchor into the material to be cut by rotating the anchor handle 1002. The anchor handle 1002 comprises a plurality of grooves 1003 and ridges 1005 so that it can be securely gripped by a user, or a robotic manipulator.
[0173] Cutter handle 1004 is connected to hole cutter 204, so that rotational motion of cutter handle 1004 is transmitted to hole cutter 204. This facilitates rotating of the hole cutter 204 around the anchor 202 once the anchor 202 is secured to the material to be cut, as the user can rotate the hole cutter 204 by rotating the cutter handle 1004. The cutter handle 1004 has a larger diameter than anchor handle 1002, and a plurality of grooves 1006, so that it can be easily gripped by a user, or a robotic manipulator, even after the anchor 202 has been secured to the material to be cut.
[0174] The operation of apparatus 1000 is the same as that of apparatus 200, except that the anchor 202 and the hole cutter 204 are rotated by anchor handle 1002 and cutter handle 1004 respectively, rather than with a separate drive tool.
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[0177] As mentioned above, alternative embodiments of the apparatus 200 may be used to cut plasterboard, wood, or other materials. In such embodiments, the hole cutter may have a larger diameter, but the rest of the apparatus may be as described above, and the method of use may be identical, i.e. the anchor is fixed to the material to be cut e.g. the plasterboard, and the hole cutter is rotated around the anchor to cut the hole.