ALIGNMENT APPARATUS

Abstract

The present invention relates to an apparatus for aligning a sensor relative to at least two anatomical reference points of a patient's anatomy. In one embodiment, the apparatus includes: a body having a central axis; a sensor mount positioned relative to the body; at least two arms extending from the body, wherein two of said at least two arms are simultaneously and equidistantly moveable relative to the central axis; and at least two aligners connected to the at least two arms for aligning with said at least two anatomical reference points. The apparatus may also include an apparatus sensor. The present invention also relates to a surgical system for monitoring the orientation of a patient's anatomy, which includes the apparatus. Furthermore, the present invention also relates to a surgical system for guiding a surgical device to an optimal orientation relative to a patient's anatomy, wherein the surgical system includes the apparatus. The present invention also relates to: a method of aligning a sensor relative to at least two anatomical reference points of a patient's anatomy, and to a method of guiding a surgical device to an optimal orientation relative to a patient's anatomy. In one embodiment, the patient's anatomy is the pelvis.

Claims

1. A surgical system for monitoring the orientation of a patient's anatomy, wherein the system includes: a. an apparatus for aligning an apparatus sensor relative to at least two anatomical reference points of a patient's anatomy to thereby sense an initial orientation of the patient's anatomy, wherein the apparatus includes: i. a body; ii. the apparatus sensor positioned relative to the body; iii. at least two arms extending from the body; and iv. at least two aligners connected to the at least two arms for aligning the apparatus with said at least two anatomical reference points; and b. a patient sensor mountable relative to the patient's anatomy by way of a patient sensor support, wherein the patient sensor is for sensing changes in the orientation of the patient's anatomy, and wherein the patient sensor support includes a fastener for mounting the patient sensor support to the patient's skin; wherein the surgical system is configured to monitor the orientation of the patient's anatomy by combining the initial orientation sensed by the apparatus sensor with the changes in orientation sensed by the patient sensor.

2. The surgical system of claim 1, wherein the fastener includes an adhesive for adhering the patient sensor support to the patient's skin.

3. The surgical system of claim 1, wherein the apparatus sensor and/or the patient sensor comprise at least one sensor for sensing the orientation of the patient's anatomy, wherein the at least one sensor is selected from one or more of a gyroscope, a magnetometer, an accelerometer, an inclinometer and an inertial sensor.

4. The surgical system of claim 1, wherein the body of the apparatus has a central axis, and two of said at least two arms are simultaneously and equidistantly moveable relative to the central axis.

5. The surgical system of claim 4, wherein the apparatus further includes a rack and pinion mechanism for simultaneously and equidistantly moving said two of said at least two arms relative to the central axis.

6. The surgical system of claim 4, wherein said at least two arms extend in a substantially common plane.

7. The surgical system of claim 4, wherein said two of said at least two arms extend on opposite sides of the central axis.

8. The surgical system of claim 4, wherein the apparatus includes a third arm extending from the body, and a third aligner connected to the third arm for aligning with a third anatomical reference point, wherein said third arm is moveable relative to the body.

9. The surgical system of claim 8, wherein the third arm extends along the central axis.

10. The surgical system of claim 1, wherein said at least two aligners extend substantially parallel to each other.

11. The surgical system of claim 1, wherein the patient's anatomy is the pelvis.

12. The surgical system of claim 11, wherein the at least two anatomical reference points are selected from the group consisting of: one or two anterior superior iliac spines, one or two posterior superior iliac spines, at least one pubic crest and the sacrum.

13. A surgical system for guiding a surgical device to an optimal orientation relative to a patient's anatomy, wherein the surgical system includes: a. the surgical system for monitoring the orientation of a patient's anatomy of claim 1; b. an orientation sensor for sensing the orientation of the surgical device; and c. a monitor for monitoring the orientation of the surgical device relative to the monitored orientation of the patient's anatomy, and for guiding the surgical device to an optimal orientation relative to the monitored patient's anatomy.

14. The surgical system of claim 13, wherein the surgical device is a surgical implement or includes a prosthetic component.

15. The surgical system of claim 13, wherein the patient's anatomy is the pelvis.

16. A method of monitoring the orientation of a patient's anatomy using the surgical system of claim 1, wherein the method includes the steps of: a. using the apparatus to align the apparatus sensor relative to the at least two anatomical reference points of the patient's anatomy; b. sensing the orientation of the patient's anatomy with the apparatus sensor, wherein the apparatus sensor is for sensing an initial orientation of the patient's anatomy; c. mounting the patient sensor relative to the patient's anatomy by mounting the patient sensor support to the patient's skin; d. sensing the orientation of the patient's anatomy with the patient sensor, wherein the patient sensor is for sensing changes in the orientation of the patient's anatomy; and e. pairing the apparatus sensor with the patient sensor, to thereby monitor the orientation of the patient's anatomy.

17. The method according to claim 16, which is a method of guiding a surgical device to an optimal orientation relative to a patient's anatomy, wherein the method further includes the steps of: f. removing the apparatus from the patient; g. sensing the orientation of a surgical device with an orientation sensor; and h. monitoring the orientation of the surgical device relative to the monitored orientation of the patient's anatomy and guiding the surgical device to an optimal orientation relative to the monitored patient's anatomy.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0104] Examples of the invention will now be described by way of example with reference to the accompanying Figures, in which:

[0105] FIG. 1 is a perspective view of an apparatus for aligning a sensor relative to at least two anatomical reference points of a patient's anatomy according to an example of the present invention;

[0106] FIG. 2 is a top view of a patient sensor support body according to an example of the present invention;

[0107] FIG. 3 is a side view of the patient sensor support body shown in FIG. 2;

[0108] FIG. 4 is a cross sectional view of the patient sensor support body of FIG. 3 through line A-A;

[0109] FIG. 5 is a top view of a patient sensor support according to a second example of the present invention, including two fasteners;

[0110] FIG. 6 is a partial bottom view of the patient sensor support shown in FIG. 5, illustrating a clamp in an open position;

[0111] FIG. 7 is an elevation view of an orientation sensor according to one example of the present invention;

[0112] FIG. 8 is a plan view of the orientation sensor shown in FIG. 7;

[0113] FIG. 9 is an elevation view of a patient sensor/apparatus sensor according to one example of the present invention;

[0114] FIG. 10 is a plan view of the patient sensor/apparatus sensor shown in FIG. 9;

[0115] FIG. 11 is a perspective view of an orientation sensor mounted to a surgical device (a placement device for placing an acetabular cup) according to one example of the present invention;

[0116] FIG. 12 is a perspective view of an orientation sensor mounted to a surgical device (an acetabular reamer) according to another example of the present invention;

[0117] FIG. 13 is an exemplary output from a monitor, showing how deviations in the patient position on the operating table and anatomical deviations in the patient may be inputted to adjust the optimal orientation angle; and

[0118] FIG. 14 is an exemplary output from a monitor, showing the pitch, roll and yaw of the surgical device relative to the optimal pitch, roll and yaw of the surgical device relative to the patient's anatomy.

[0119] Preferred features, embodiments and variations of the invention may be discerned from the following Description which provides sufficient information for those skilled in the art to perform the invention. The following Description is not to be regarded as limiting the scope of the preceding Summary of the Invention in any way.

DESCRIPTION OF EMBODIMENTS

[0120] Embodiments and features of the present invention are illustrated with reference to FIGS. 1 to 14. In the figures, like numbers refer to like features.

[0121] FIG. 1 illustrates an apparatus 1 for aligning a sensor 10 relative to at least two anatomical reference points of a patient's anatomy. The apparatus 1 includes a body 20 having a central axis 22, a sensor mount 30, and at least two arms 40 extending from the body 20, wherein two of said at least two arms (40a, 40b) are simultaneously and equidistantly moveable relative to the central axis 22. The apparatus 1 also includes at least two aligners 50 connected to the at least two arms 40 for aligning with said at least two anatomical reference points.

[0122] The apparatus 1 includes an arm mechanism 60 for simultaneously and equidistantly moving the arms 40a, 40b relative to the central axis 22. The arm mechanism 60 operates manually and is geared. The arm mechanism 60 is a rack and pinion mechanism. Therefore, the arm mechanism 60 includes a pinion 62 and the two arms 40a, 40b each include a rack 64a, 64b (in the form of teeth on the two arms 40a, 40b). Rotation of the pinion 62 results in simultaneous movement of the two arms 40a, 40b towards and away from the central axis 22. The pinion 62 includes a handle 66 for actuating the pinion 62. The arm mechanism 60 also includes a brake 68 to prevent movement of the two arms 40a, 40b. The brake 68 includes a brake pad (positioned between the handle 66 and the body 20not shown in FIG. 1) and a knob 68a. Rotation of the knob 68a drives the pinion handle 66 into the brake pad, preventing the handle 66 from turning to actuate the pinion 62.

[0123] The apparatus 1 includes three arms 40a, 40b, 40c (collectively 40). The three arms 40 generally extend relative to each other in a T-shape. Each arm 40 is substantially straight.

[0124] The body 20 includes two sleeves 24a, 24b (collectively 24). Arms 40a, 40b are supported by and extend through sleeve 24a. Arm 40c is supported by and extends through sleeve 24b. Each sleeve 24 is substantially rectangular in shape. Sleeve 24a is oriented substantially perpendicularly to sleeve 24b.

[0125] Arm 40c extends along the central axis 22. Arm 40c includes a longitudinally extending slot 42. The apparatus 1 further includes a lock 44 for the third arm 40c. The lock 44 includes a fastener 46 having a handle 47. The fastener 46 traverses two opposed walls of sleeve 24b through slot 42. Rotation of fastener 46 draws the walls of the sleeve 24b together, thereby locking arm 40c in position.

[0126] Sensor mount 30 may be releasably attached to the third arm 40c. Sensor mount includes a clamp 32. Clamp 32 includes a channel 34 and a fastener 36 in the form of a screw, in which the fastener 36 traverses the two opposed walls of the channel 34 and passes through the slot 42 of third arm 40c. Rotation of the fastener 36 draws the walls of the channel 34 together to clamp the sensor mount 30 on arm 40c.

[0127] The apparatus also includes apparatus sensor 10. Apparatus sensor 10 is in slideably engageable with the sensor mount. An exemplary apparatus/patient sensor 100 is illustrated in FIGS. 9 and 10.

[0128] The apparatus/patient sensor 100 includes a power supply 102 (in the form of one or two batteries), a housing 104, and a sensor 106. The battery (or batteries) is especially sterilisable, and most especially is a lithium ion battery (e.g. 3.6V). The battery may be rechargeable or non-rechargeable. The sensor 106 is able to measure orientation in three axes (pitch, roll and yaw), and contains a wireless data transmission (such as Blue Tooth or Wi-Fi connection). The sensor 106 may include pitch and roll sensors with 2.4 GHz wireless transmission, and a yaw sensor with an ultra-sensitive magnetometer. The sensor 106 may be non-magnetisable and be able to be quickly and securely positioned in the apparatus/patient sensor 100. The apparatus/patient sensor 100 may also include an indicator, such as a light, for indicating the power remaining in the power supply 102. The apparatus/patient sensor 100 may be a 3 axis self-powered Wi-Fi transmitter.

[0129] Referring to FIG. 1, apparatus 1 also includes an aligner 50a, 50b, 50c (collectively 50) connected to each arm 40. The aligners 50 are oriented perpendicularly to a substantially common plane within which the arms 40 lie. The aligners 50 are all moveable in a direction perpendicular to the direction of movement for each arm 40.

[0130] Each arm 40 terminates at a sleeve 48a, 48b, 48c (collectively 48), and each aligner 50 is moveable within said sleeve 48. Each aligner 50 includes a rod 52a, 52b, 52c (collectively 52) moveable within each sleeve 48. Each rod 52 includes a plurality of detents or apertures engageable with fasteners 54a, 54b, 54c (collectively 54) (e.g. screws) mounted to each arm sleeve 48 for preventing movement of the aligner 50. Each aligner 50 is the same length.

[0131] Each aligner 50 includes an end 56a, 56b, 56c (collectively 56) for alignment with an anatomical reference point. Each end 56 is blunt and bulbous, but has a contoured shape to conform to the anatomical reference point. Ends 56a, 56b are designed to be aligned with the two anterior superior iliac spines and may include a groove, and end 56c is designed to be aligned with at least one pubic crest and may include a central ridge (i.e. the patient's anatomy is the pelvis). The pad at the terminus of each end 56 is of 10-20 cm in diameter.

[0132] The aligner ends are made from heat resistant nylon, the aligner rods are made from titanium, and where allowing, the remainder of apparatus 1 is made from non-magnetisable stainless steel grade 316.

[0133] The apparatus 1 may form part of a surgical system. The surgical system may further include a patient sensor 100 and patient sensor support 200. The patient sensor 100 is mountable relative to the patient's anatomy and is for sensing changes in the orientation of the patient's anatomy. The patient sensor supports 200 illustrated in FIGS. 2-6 are intended to be mounted relative to the sacrum, and the patient sensor 100 is for sensing changes in the orientation of the patient's pelvis. The patient sensor support 200 is substantially rigid.

[0134] The patient sensor support 200 includes a body 210 which is of substantially rectangular shape. The body 210 includes a patient sensor mount 212 for mounting the patient sensor 100. The patient sensor 100 is slideably engageable with the patient sensor mount 212. Patient sensor mount 212 may include a clamp 214 to secure the patient sensor, as illustrated in FIG. 5.

[0135] The patient sensor support 200 includes at least one fastener 230. The patient sensor supports 200 illustrated in FIGS. 2-6 are intended to include four fasteners 230, one at each corner. The fasteners 230 are in the form of adhesive tabs (such as those used in ECG) which have an adhesive surface for adhering to the patient's skin. The adhesive tabs also have a projection (which may be substantially cylindrically shaped) opposite the adhesive surface.

[0136] The patient sensor support 200 also includes four clamps 240 (see FIGS. 4 to 6; the space where the clamps 240 are attached to the body 210 is marked in FIGS. 2-4 at 242). The clamps 240 are pivotally mounted to the body 210 at 244 (see FIG. 4). Each clamp 240 includes a biasing member 246 (see FIG. 5) in the form of a spring to bias the clamp to a closed position. The clamp includes a lever 248. The lever 248 has a jaw 250 at one end and an actuator 252 at an opposite end. The actuator 252 is depressed by an operator to move the clamp 240 to an open position.

[0137] The patient sensor support body may be made of any suitable material, such as polycarbonate. The patient sensor support is sterilisable.

[0138] The surgical system is configured to monitor the orientation of the patient's anatomy by combining the initial orientation sensed by the apparatus sensor 10 with the changes in orientation sensed by the patient sensor 100. This may be achieved by pairing the sensors 10, 100, or by transmitting the data to a monitor for processing.

[0139] The surgical system may also include an orientation sensor 300 (see FIGS. 7, 8, 11 and 12). The orientation sensor 300 may include power supply 302 (in the form of battery), a housing 304, and a sensor 306. Features of the orientation sensor 300 may be as described above for the patient/apparatus sensor 100.

[0140] As shown in FIGS. 8 and 10, the sensors 100, 300 have an arrow pointing in the sensor pairing direction which will, when attached to the apparatus sensor mount 30, the patient sensor support 200 or the orientation sensor mount 510, be the direction towards the patient's head when in use.

[0141] The orientation sensor 300 may be mounted to a surgical device 500. An exemplary surgical device includes a placement device for placing a prosthetic component together with the prosthetic component (such as an acetabular cup inserter 500a and acetabular cup 500b, as shown in FIG. 11). A further exemplary surgical device includes a surgical implement such as a reamer (such as the acetabular reamer 500c shown in FIG. 12). In either case, the orientation sensor 300 may be mounted to the surgical device 500 by way of an orientation sensor mount 510.

[0142] The acetabular cup inserter 500a illustrated in FIG. 11 is a curved acetabular cup inserter (the knob 502 is for releasably coupling the acetabular cup 500b). An exemplary acetabular cup inserter 500a is manufactured by DePuy (Catalogue Number 920010029). The orientation sensor mount 510 includes a docking port 512 into which the orientation sensor 300 is screwed (an alternative arrangement in which orientation sensor 300 is slideably engaged with docking port 512 may also be used). The mount 510 also includes a bracket 520 for holding a monitor 600 (in the form of a tablet (or an iPad) or a smartphone (such as an iPhone) or the like). In use, the tablet or smartphone may be encased within a sterilisable housing which is held in, or forms part of the bracket 520. Alternatively, the mount 510 does not include bracket 520. Instead, the system further includes a stand for monitor 600 which is independent to the mount 510. The stand may be positionable on the floor of the operating theatre and be located in visual proximity to the surgeon. A suitable stand may be a music stand for an iPad or the like.

[0143] The mount 510 also includes a shock absorber 514. The shock absorber 514 may be biased against the handle of the placement device 500a, and may be assembled with an impact shaft (spool) (preferably titanium), a coil spring (preferably stainless steel), and a pneumatic compression chamber. A collar on the titanium spool may abut the spring, and the end of the titanium spool may extend partway into the compression chamber. However, the pneumatic compression chamber is optional. Other types of shock absorbers may be used, such as a two-direction shock absorber.

[0144] The mount 510 may include a clamp 516 for clamping the mount 510 to the placement device 500a. The clamp 516 illustrated in FIG. 11 includes a fastener such as bolts and lock nuts. The mount 510 may be made from a sterilisable material, and the body of the mount 510 may be especially made of stainless steel (such as grade 316). The mount 510 is especially made of a non-magnetisable material.

[0145] An acetabular reamer 500c includes a cutting blade 560, an acetabular reamer driver 562, and a motor 564. The acetabular reamer 500c has a slot next to a handle 566 (the handle 566 forms part of the acetabular reamer driver 562), to which the orientation sensor mount 510 may be clamped. An exemplary acetabular reamer driver is the DePuy angled reamer driver catalogue number 920010031.

[0146] However, in the acetabular reamer 500c illustrated in FIG. 12 the acetabular reamer driver 562 is integrally formed with orientation sensor mount 510. The mount 510 includes a docking port 512 into which the orientation sensor 300 may be screwed (an alternative arrangement in which orientation sensor 300 is slideably engaged with docking port 512 may also be used), and bracket 520 for holding a monitor 600 in the form of a tablet (or an iPad) or smartphone (such as an iPhone) or the like. In use, the tablet or smartphone may be encased within a sterilisable housing which is held in, or forms part of the bracket 520. Alternatively, mount 510 does not include bracket 520. Instead, the system further includes a stand for monitor 600 which is independent to the mount 510. The stand may be positionable on the floor of the operating theatre and be located in visual proximity to the surgeon. A suitable stand may be a music stand for an iPad or the like.

[0147] The surgical system may be used according to the following steps: [0148] 1. Place the patient on the operating table, preferably lying on their side. [0149] 2. Start software using monitor 600 (e.g. computer (including a tablet or iPad)). [0150] 3. Enter details of the procedure, including the surgeon's name, the patient's name, the hospital name, the date of birth of the patient and the date of the procedure. [0151] 4. Enter any offsets for inclination and anteversion (or pitch, roll and yaw) in view of the patient's anatomy (for example due to natural variations in the patient's anatomy). See FIG. 13. This information may be obtained through a pre-operative scan such as an X-ray. [0152] 5. Place apparatus, patient and orientation sensors in a tray so that all three sensors are generally uniformly aligned. Pair (calibrate) the sensors, such that the pitch, roll and yaw for all sensors are substantially zero. [0153] 6. Place patient sensor support 200 over patient's sacrum. Insert patient sensor 100 into patient sensor mount 212. [0154] 7. Move arms 40 of alignment apparatus 1 so that aligners 50a, 50b align with the patient's anterior superior iliac spines, and so that aligner 50c aligns with the patient's at least one pubic crest. Move aligners 50 within arm sleeves 48 so that apparatus sensor mount 30 is positioned close to patient's body. Set all aligners 50 at the same height relative to arms 40. Insert apparatus sensor 10 into mount 30. [0155] 8. When the apparatus 1 is in the correct position, pair (or lock) patient and apparatus sensors 10,100 so that the system monitors the orientation of the patient's pelvis. This information is used to define the patient's coronal (and possibly also sagittal) planes. Data from the apparatus sensor and patient sensor provides an initial orientation of the patient's pelvis and also changes in the orientation of the patient's pelvis, which together provides a monitored orientation of the pelvis. Using this data and the data previously obtained, the optimal orientation of the surgical device relative to the patient's pelvis may be calculated. [0156] 9. Remove apparatus 1 from patient. [0157] 10. Assemble and make ready an appropriate pelvic support brace and set the patient ready for covering; [0158] 11. Insert orientation sensor into orientation sensor mount on surgical device. [0159] 12. View on the monitor 600 the orientation of the surgical device relative to the patient's anatomy, and also the difference between the present orientation of the surgical device and the optimal orientation. See FIG. 14. [0160] 13. Perform the acetabular reaming or acetabular cup placement operation. [0161] 14. A record of the output of the surgical system during the operation may be stored on a memory card for future reference.

[0162] In the present specification and claims (if any), the word comprising and its derivatives including comprises and comprise include each of the stated integers but does not exclude the inclusion of one or more further integers.

[0163] Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

[0164] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art.