Reference device

Abstract

A reference device for application to a patient, the reference device comprising: a support plate; a first positioning element extending from the support plate; a second positioning element extending from the upper support plate; a third positioning element extending from the upper support plate; and an electronic orientation monitor housing adapted to receive an electronic orientation monitor; a docking station adapted to receive the housing thereby defining an external reference point relative to the patient's anatomy; wherein the first positioning element, the second positioning element and the third positioning element are arranged to be pushed down onto the patient thereby providing the electronic orientation monitor with a reference orientation relative to a predetermined anatomical site.

Description

Technical Field

[0001] This invention relates to surgical instruments and surgical methods, and more particularly to a reference device that can be applied to a patient before or during surgical procedures such as hip surgery involving prosthetic components. Background Technology

[0002] The discussion of prior art in this specification is not, and should not be construed as, an admission of the scope of common general knowledge in the field of this invention. Rather, the discussion of prior art is provided solely to assist the recipient in understanding the invention and is included without prejudice.

[0003] Although the following discussion pertains to hip replacement surgery, those skilled in the art will understand that the invention is not limited to this specific field of application, but is applicable to any bone structure or various types of surgery.

[0004] Hip replacement surgery involves using a prosthetic cup (acetabular cup) or a prosthetic ball (femoral stem), or both, to restore the function of the hip joint's ball-and-socket joint. This ball-and-socket joint allows the hip joint to rotate at different angles in different directions (compared to the relatively limited rotation of the knee joint).

[0005] Historically, hip replacement surgery (arthroplasty) required a curved incision of up to 40 centimeters (7 to 12 inches) to provide sufficient access for surgeons to manually approach and manipulate the hip joint and femur. A prosthetic cup was attached to the hip socket, or the femoral head was removed and replaced with a prosthetic ball, or both.

[0006] After the incision is made, the ligaments and muscles are separated to allow the surgeon access to the bone of the hip joint. This part of the surgery usually leaves the ligaments and muscles somewhat weak after the operation. Patients must follow special hip precautions to prevent new hip dislocations, as the healing process typically takes one to six weeks.

[0007] Typical steps in hip replacement surgery include:

[0008] ■ Removal of the femoral head: After entering the hip joint, the femoral head is dislocated from the acetabulum. The femoral neck is then cut open with a power saw to remove the femoral head.

[0009] ■ Acral reaming: After removing the femoral head, cartilage is removed from the acetabulum using an electric drill and a special reamer. The reamer shapes the bone into a hemispherical shape to precisely fit the metal shell of the acetabular prosthesis.

[0010] ■ Insertion of the acetabular component: The test prosthesis is an exact replica of the patient's existing hip prosthesis, used to ensure the received joint has the correct size and fit. After determining the correct size and shape of the acetabulum, the acetabular prosthesis is inserted into place. In various uncemented hip replacements, the metal shell is held in place simply by a tight fit, or by screws. In cemented hip replacements, a special epoxy resin-based bone cement is used to "bond" the acetabular prosthesis to the bone.

[0011] ■ Preparing the femoral conduit: To begin femoral head replacement, the femur is reshaped and hollowed out using a special file to perfectly match the shape of the metal stem of the femoral prosthesis. Similarly, a trial prosthesis is used to ensure the correct size and shape. The surgeon will also test hip joint movement.

[0012] ■ Insertion of the femoral stem: The femoral stem is inserted into the femoral canal once the size and shape of the canal are precisely matched to the femoral prosthesis. Similarly, in various uncemented femoral prostheses, the femoral stem is held in place by a tight fit with the bone (similar to the friction of fixing a nail in a hole drilled in a board slightly smaller in diameter than the nail). In cemented femoral prostheses, the femoral canal is filed to a size slightly larger than the femoral stem. The metal stem is then bonded to the bone using epoxy-based bone cement.

[0013] ■Femoral head attachment: A metal ball that replaces the femoral head is attached to the femoral stem.

[0014] ■Complete hip replacement: Before closing the incision, an X-ray is performed to ensure the new prosthesis is in the correct position.

[0015] Such surgery has many problems, including:

[0016] ■ Hospitalization for more than three days, postoperative pain, and several weeks of recovery required;

[0017] ■After surgery, every centimeter of incision increases the risk of clotting and infection tenfold;

[0018] ■ Surgeons rely on their experience and eyesight to ensure precise placement of the prosthesis cup within the three-dimensional hip socket and alignment of the prosthesis cup with the ball of the foot / femur so that the joint can function correctly. Misalignment can lead to postoperative complications such as leg displacement, incorrect leg length, and / or incorrect soft tissue tension. Long-term effects of prosthesis component misalignment also include accelerated wear of the component, aseptic loosening of the component, and possible premature repeat surgery.

[0019] Attempts to overcome these problems include:

[0020] ■WO 2003 / 037192 discloses a clamp (impact tool) for orthopedic surgery, enabling the use of smaller incisions. For hip replacement surgery, this clamp allows for incisions of 4 to 7 centimeters (2 to 3 inches), i.e., minimally invasive surgery. Other benefits include shorter hospital stays, less blood loss, less pain, less postoperative dislocation, and faster recovery;

[0021] ■WO 2005 / 046475 discloses a gauge that helps surgeons accurately place prostheses when using clamps in minimally invasive surgery, because surgeons can no longer see the fit between the cup and the hip socket or the fit between the ball and the cup in minimally invasive surgery.

[0022] ■WO 2010 / 031111 discloses a stent designed to define the placement of a prosthesis relative to a patient reference point during use.

[0023] The gauges provided in WO 2005 / 046475 support efficient use of the impact tools in WO 2003 / 037192. Commercially available examples include the NivNav Hip system, which is available from MAC Surgical. However, this gauge only works in two dimensions and still relies heavily on the surgeon's eye and experience to optimally position the cup in the hip joint.

[0024] WO 2010 / 031111 provides further attempts to overcome these problems, the contents of which are incorporated herein by reference in their entirety. This prior art document discloses a clamp-like support (3) that can be attached to a patient to define a reference point relative to the patient's anatomy. This prior art clamp has multiple pads (14, 16, 17, and 18) arranged at different points abutting against the patient's anatomy. However, the inventors recognize that such a clamp may hinder at least some surgical procedures and is not readily adaptable to surgical drapes commonly used in many surgical settings. Summary of the Invention

[0025] The purpose of this invention is to overcome or improve at least one or more disadvantages of the prior art, or to provide a useful alternative.

[0026] According to a first aspect of the invention, a reference device for use with a patient is provided. The reference device may include a support plate. The reference device may also include a first positioning element extending from the support plate. The reference device may also include a second positioning element extending from an upper support plate. The reference device may also include a third positioning element extending from the upper support plate. The reference device may also include an electronic orientation monitor housing adapted to receive an electronic orientation monitor. The reference device may also include a docking station adapted to receive the housing, thereby defining an external reference point relative to the patient's anatomy. The first, second, and third positioning elements may be arranged to be pushed downwards onto the patient, thereby providing a reference orientation for the electronic orientation monitor relative to a predetermined anatomical location.

[0027] According to a particular arrangement of the first aspect, a reference device for use with a patient is provided, the reference device comprising: a support plate; a first positioning element extending from the support plate; a second positioning element extending from an upper support plate; a third positioning element extending from the upper support plate; and an electronic orientation monitor housing adapted to receive an electronic orientation monitor; a docking station adapted to receive the housing thereby defining an external reference point relative to the patient's anatomical structure; wherein the first positioning element, the second positioning element, and the third positioning element are arranged to be pushed downward onto the patient, thereby providing the electronic orientation monitor with a reference orientation relative to a predetermined anatomical site.

[0028] The housing may be a sterile housing. The housing may include: a body including an opening adapted to receive an orientation monitor; a loading funnel including angled guide walls and an insertion wall for allowing an unsterilized orientation monitor to be inserted into the sterile housing while preventing contamination of the sterile housing; and a locking device including a closed frame adapted to engage with a docking station, wherein the frame is pivotally attached to the body of the housing. The housing may be a clamshell-type housing.

[0029] The loading funnel may be a transfer shield adapted to be placed on the opening of the housing to protect the sterile components of the housing during use when the monitor is inserted into the housing through the shield.

[0030] The locking device may include a central aperture shaped to receive a docking station therein, thereby securing the orientation monitor to the reference device to define the orientation of the motorized orientation monitor relative to the patient.

[0031] The first and second positioning elements can be a first and a second anterior superior iliac spine positioning element. The third positioning element can be a pubic bone positioning element. The first and second positioning elements can include a patient connection plate. This patient connection plate can be arranged to be fixed to the patient above the anterior superior iliac spine.

[0032] An electronic orientation monitor can dock with a docking station in either a first docking configuration or a second docking configuration. The electronic orientation monitor can be housed within an electronic orientation monitor housing. This housing can be arranged to engage with a support plate, thereby providing a reference orientation for the electronic orientation monitor.

[0033] The first docking configuration can define a first orientation of the electronic orientation monitor relative to the reference device. The second docking configuration can define a second orientation of the electronic orientation monitor relative to the reference device.

[0034] According to a second aspect of the invention, a method is provided for calibrating an electronic orientation monitor using a reference device as defined in the first aspect. The method may include the step of positioning a patient connector plate on the left anterior superior iliac spine. The method may also include the step of positioning a patient connector plate on the right anterior superior iliac spine. The method may further include the step of connecting a first positioning element and a second positioning element to the respective patient connector plate. The method may further include the step of positioning a third positioning element against the pubic bone. The method may further include the step of placing the electronic orientation monitor in a sterile housing, the sterile housing including means for receiving an unsterilized monitor while preventing contamination of the sterile housing. The method may further include the step of engaging a housing containing the monitor disposed therein to a docking station arranged on the reference device to take an external reference orientation relative to a patient. The method may further include the step of calibrating the electronic orientation monitor.

[0035] According to a specific arrangement of the second aspect, a method is provided for calibrating an electronic orientation monitor using a reference device as defined in the first aspect, the method comprising the steps of: positioning a patient connector plate on the left anterior superior iliac spine; positioning a patient connector plate on the right anterior superior iliac spine; connecting a first positioning element and a second positioning element to the respective patient connector plate; positioning a third positioning element against the pubis; placing the electronic orientation monitor in a sterile housing including means for receiving an unsterilized monitor while preventing contamination of the sterile housing; engaging the housing containing the monitor disposed therein to a docking station arranged on the reference device to take an external reference orientation relative to the patient; and calibrating the electronic orientation monitor.

[0036] The reference device can be positioned in front of the patient during the step of pressing the reference device to engage with the surgical drape and during the calibration of the electronic orientation monitor. An anterior approach can be used as the surgical access route to the patient's acetabulum.

[0037] In the above procedure, the patient can be in a supine position with their face up.

[0038] According to a third aspect of the invention, a method is provided for calibrating an electronic orientation monitor using a reference device as defined in the first aspect. The method may include the step of placing a surgical drape on a patient. The method may further include the step of engaging a plurality of positioning elements against the surgical drape, such that the drape is positioned between the plurality of positioning elements and corresponding predetermined anatomical sites on the patient, thereby causing a docking station disposed on the reference device to adopt a reference orientation relative to the plurality of predetermined anatomical sites. The method may further include the step of placing the electronic orientation monitor in a sterile housing and docking the housing with the docking station to bring the electronic orientation monitor into a reference orientation, the sterile housing including means for receiving an unsterilized monitor while preventing contamination of the sterile housing. The method may further include the step of calibrating the electronic orientation monitor.

[0039] According to a specific arrangement of the third aspect, a method is provided for calibrating an electronic orientation monitor using a reference device as defined in the first aspect, the method comprising the steps of: placing a surgical drape on a patient; engaging a plurality of positioning elements against the surgical drape such that the drape is positioned between the plurality of positioning elements and corresponding predetermined anatomical sites of the patient, such that a docking station disposed on the reference device adopts a reference orientation relative to the plurality of predetermined anatomical sites; placing the electronic orientation monitor in a sterile housing and docking the housing with the docking station to position the electronic orientation monitor in the reference orientation, the sterile housing including means for receiving an unsterilized monitor while preventing contamination of the sterile housing; and calibrating the electronic orientation monitor. Attached Figure Description

[0040] Embodiments of the invention will now be described by way of example with reference to the accompanying drawings, in which:

[0041] Figure 1 This is a perspective view of a reference device according to a first embodiment of the present invention;

[0042] Figure 2 yes Figure 1 A perspective view of a reference device according to an embodiment;

[0043] Figure 2A This is a perspective view of another embodiment of the reference device;

[0044] Figure 2B This is a perspective view of another embodiment of the reference device;

[0045] Figure 3 Is with Figure 1 A partial perspective view of the first or second positioning element used in conjunction with the reference device;

[0046] Figure 4 yes Figure 3 A cross-sectional view of the first or second positioning element;

[0047] Figure 5 Is with Figure 1 Exploded view of the electronic orientation monitor used in conjunction with the reference device;

[0048] Figure 5A and 5B An alternative embodiment of an electronic orientation monitor housing, including a clamshell-type housing and a transfer shield, is shown;

[0049] Figure 5C yes Figure 5A Exploded view of the alternative electronic orientation monitor;

[0050] Figure 6 It is used for Figure 5 A perspective view of the clamshell-shaped housing of the electronic orientation monitor;

[0051] Figure 7 yes Figure 6 A side view of a clamshell-like shell; and

[0052] Figure 8A and 8B It shows the relationship with Figure 1 An embodiment of the reference device features a clamshell-type housing.

[0053] Figure 9 It is attached to the surgical impact device Figure 5 A perspective view of an electronic orientation monitor. Detailed Implementation

[0054] In summary, the present invention relates to a reference device 100 applied to a patient for hip surgery, such as, but not limited to, hip replacement. Referring to the accompanying drawings, the reference device 100 of the present invention assists the surgeon in positioning a prosthetic component relative to the patient's anatomy during surgery. The reference device 100 can be placed by the surgeon on the patient to easily and reliably define the orientation of an electronic orientation monitor 46 within a housing 12. Once the orientation is defined, the electronic orientation monitor can be detached from the reference device 100 and attached to the prosthetic component to provide detailed positional information of the prosthetic component for reliable and precise insertion into the patient. The prosthetic component may, for example, be a surgical impact device for placing the prosthetic component into the patient. The orientation monitor provides detailed positional information of the impact device, which is equivalent to the position of the prosthesis, to ensure accurate placement of the prosthetic component within the patient. The orientation monitor 46 includes an inertial measurement unit (IMU) comprising a three-axis digital gyroscope and a three-axis digital accelerometer. In a particular embodiment, the IMU is an integrated digital gyroscope and accelerometer sensor specifically designed for inertial measurement, offering greater dynamic range, higher sensitivity, higher accuracy, lower offset, and lower drift compared to existing gyroscope / accelerometer implementations. In a particular embodiment, the selected IMU enables precise position sensing and determination without the need for additional navigation components, such as magnetometers or compasses, that could be affected by interference from local magnetic fields (e.g., from medical imaging equipment), which could adversely impact the accuracy of critical orientation parameters that must be determined by the orientation monitor 46. In a particular embodiment, the surgeon may have the ability to select or input specific prosthesis angles and related data into the orientation monitor 46 to assist and fine-tune orientation calibration relative to the patient's unique anatomy.

[0055] This preferred embodiment is particularly suitable for assisting surgeons in correctly positioning the acetabular cup within the enlarged acetabulum during hip surgery (e.g., total or partial hip replacement or revision). When used in this context, the reference device 100 is pushed downwards onto the patient's pelvis to establish a reference position that defines the orientation of the electronic orientation monitor 46, thereby aiding in the positioning of the surgical impact device and prosthetic components.

[0056] This detailed description will describe the use of the reference device 100 and the electronic orientation monitor 46 as an auxiliary means of inserting a prosthetic component in the form of an acetabular cup into an enlarged acetabulum in a patient's pelvis, wherein an anterior approach is used as the surgical access to the patient's acetabulum. An important part of this process is using the reference device 100 to calibrate the electronic orientation monitor 46, which may be similar to the monitor disclosed in the applicant's prior application WO 2010 / 031111, the contents of which are incorporated herein by reference in their entirety. However, those skilled in the art will understand that the invention can also be used in other surgical settings.

[0057] Please refer to the accompanying drawings. The reference device 100 includes the following components:

[0058] ■Frame 10, which is used to position the electronic orientation monitor at a reference position relative to the patient;

[0059] ■ First and second anterior superior iliac spine (ASIS) positioning elements 14;

[0060] ■Third pubic bone positioning element 16;

[0061] ■ Electronic orientation monitor 46; and

[0062] ■ Electronic orientation monitor housing 12.

[0063] The frame 10 includes an upper support plate in the form of a grooved segment 11 and a T-shaped groove segment 15 extending perpendicularly from the grooved segment 11. A first ASIS positioning element 14 extends outward from the base of one longitudinal end of the grooved segment 11, and a second ASIS positioning element 14 extends from the opposite longitudinal end of the grooved segment 11. A third pubic positioning element 16 extends outward from the base of the T-shaped groove segment 15.

[0064] The force plate 13 forms part of the groove segment 11 and provides an interface for applying a downward force applied to the reference device 100 to the patient via positioning elements 14, 16 to define the orientation of the electronic orientation monitor 46.

[0065] First and second ASIS positioning elements 14 are connected to the groove segment 11 and extend outward and generally perpendicular to the groove segment 11. In one embodiment, to provide the ability to use a single-sized reference device 100 on patients of different sizes and hip joint profiles, the first and second ASIS positioning elements 14 are attached to the groove segment 11 such that they can be secured in different positions. In one embodiment, the connection surface of the groove segment 11 has a plurality of fixation points from which the first and second ASIS positioning elements 14 can be attached. In an alternative embodiment, the underside of the groove segment 11 includes a track having attachment points for the first and second ASIS positioning elements 14. The attachment points can be locked in place as needed.

[0066] The third pubic positioning element 16 is connected to the T-groove segment 15 and extends outward and substantially perpendicular to the T-groove segment 15. In one embodiment, to provide the ability to use a single-sized reference device 100 on patients of different sizes and hip joint profiles, the third pubic positioning element 16 is attached to the T-groove segment 15 so that it can be fixed in different positions. In one embodiment, the connection surface of the T-groove segment 15 has a plurality of fixation points from which the third pubic positioning element 16 can be attached.

[0067] In an alternative embodiment, the lower side of the T-slot segment 15 includes a track having an attachment point for the third pubic bone positioning element 16. The attachment point can be locked in place as needed.

[0068] Docking station 19 extends from the grooved segment 11 and is shaped to receive an electronic orientation monitor 46 contained within a housing 12. The docking station 19 is designed to have high tolerance and positions the monitor 46 in a precisely defined location without compromising the accuracy of the measurement system. Engaging any of the docking stations 19 with the electronic orientation monitor 46 contained within the housing 12 defines a reference point relative to the patient's anatomy. This reference point is outside the patient's body and is used to orient the electronic orientation monitor 46 to the reference orientation. In this orientation, the electronic orientation monitor 46 acquires reference orientation information for calibrating the electronic orientation monitor 46 to the reference orientation. In one embodiment, as... Figure 1 As shown, the docking station 19 of the frame 10 includes a central aperture 17, and the profile of the docking station 19 allows it to receive and secure the electronic orientation monitor 46. In other embodiments of the frame (e.g.) Figure 2B The frame 70), the docking station 19 does not include the orifice.

[0069] The first and second ASIS positioning elements 14 include a rod extension 20 extending from the base of the grooved segment 11, a base 21, and a patient connection plate 18. The patient connection plate 18 is arranged to be secured to the patient's body above the ASIS. The position of the patient connection plate 18 defines the placement of the first and second ASIS positioning elements 14 on the patient.

[0070] The pubic positioning element 16 extends as a rod from the grooved segment 11 and terminates at the pubic probe 23. The shape of the pubic probe 23 allows it to fit snugly within the patient's pubic ridge during use. With the pubic probe 23 positioned between the patient's pubic ridges and the first and second ASIS positioning elements 14 in place on the connecting plate 18, the grooved segment 11 and the reference device 100 as a whole are known relative to a known reference position of the patient.

[0071] At this known location, the electronic orientation monitor 46 can be positioned within the electronic orientation monitor housing 12 onto a docking station 19 suitable for the hip joint on which surgery will be performed, according to the surgeon's personal preference. That is, regardless of which hip joint the surgeon is operating on, the surgeon can place the orientation monitor 46 within the housing 12 and attach the housing to either of the two docking stations 19 of the reference device 100 (on the left or right side of frames 10, 70). In practice, the range of desired locations chosen by the surgeon for the orientation monitor 46 is limited by the patient's anatomy and clinical outcomes. The location chosen by the surgeon is determined by the type of implant and the patient's anatomy combined with the surgeon's clinical judgment. The reference device 100 can be considered as having established a commonly used / accepted predefined orientation relative to the patient's anatomy. Adding the orientation monitor 46 to the device 100 provides the surgeon with real-time positional feedback, enabling the surgeon to position the implant at a desired location that may differ from the predetermined location, if the surgeon deems the desired location appropriate.

[0072] Figure 2A An alternative embodiment 50 of the frame 10 is shown, wherein the grooved segment 11 and the T-shaped grooved segment 15 of the previous embodiment are replaced by rigid non-grooved arms 51 and 52, respectively, and the frame 10 is replaced by a non-grooved frame 50. Adjustment slots 52 and 53 are provided within at least one of the arms 51 and within the T-shaped segment 54 for adjusting the spacing between the first and second ASIS positioning elements 14 having feet 22, and also for adjusting the pubic positioning element 16 relative to the patient's unique anatomy. This is described in more detail in Australian Patent No. AU2013204941. Figure 2A The specific embodiments shown are incorporated herein by reference in their entirety.

[0073] Figure 2BAn alternative embodiment 70 of frames 10 and 50 is shown, in which a slotted cross-section frame is not used, but slots 71 and 72 are provided on the arms 74 of frame 70, and slot 75 is provided on the T-section 76 (essentially similar to...). Figure 2A (slots 52 and 53). In this embodiment, ASIS positioning element 14 terminates in a lever locking system that engages with slots 71 and 72 of frame 70, respectively. Similarly, pubic positioning element 16 terminates in a lever locking system that engages with slot 75, thereby allowing adjustment of ASIS positioning element 14 and pubic positioning element 16 to locate the patient's anatomical features, and then locking ASIS positioning element 14 and pubic positioning element 16 into place. Figure 2A As shown, slots 71 and 72 of arm 74 and slot 75 of T-section 76 may optionally include a series of regularly spaced indentations to help properly position the positioning elements 14 and 16, and also to help the locking clamp hold the positioning elements 14 and 16 in place.

[0074] Figure 2B The docking station 19 of the illustrated embodiment also includes a magnet positioning feature 77. The positioning feature 77 is sensed by the orientation monitor 46 when engaging with any of the docking stations 19. The positioning feature 77 senses the placement of the orientation monitor housing 12, including the orientation monitor 46, and helps ensure that the reference device 100 is used in a predetermined manner and avoids errors, such as those that could occur if the monitor 46 or the frames 10, 50, 70 are used without proper calibration.

[0075] like Figure 3 and Figure 4 As best shown, the patient connection plate 18 includes a central annular projection 29 defined by the periphery 22 of the first and second ASIS positioning elements 14, a central aperture 30 defined by the central annular projection 29, a base 27, and a base projection 28. The central annular projection 29 is received in a recess 32 defined by the periphery 22 of the first and second ASIS positioning elements 14. When the patient connection plate 18 is fixedly positioned on the second ASIS on the left and right sides, the recess 32 on the first and second ASIS positioning elements 14 can be positioned above the central annular projection to place the reference device 100 in a reference orientation when the pubic positioning element 16 is also in place. The annular structure of the patient connection plate 18 also allows the surgeon to easily place the patient connection plate 18 directly on the patient's ASIS when the patient is covered by a surgical drape.

[0076] Figure 4The patient connection plate 18 is shown being secured to a patient. An adhesive sterile membrane 35 is applied to the patient's skin 36. A connection plate adhesive patch 34 is adhered to the adhesive membrane 35 on the anterior superior iliac spine and secured externally to position the electronic orientation monitor 46 in a reference orientation. In this orientation, the electronic orientation monitor 46 acquires reference orientation information for calibrating itself to the reference orientation. A patient cover 33 can be placed between the patient connection plate 18 and the first and second anterior superior iliac spine positioning elements 14.

[0077] Figures 5 to 8B An electronic orientation monitor 46 and an electronic orientation monitor housing 12 are shown. The electronic orientation monitor housing 12 is a sterile housing, so that the electronic orientation monitor 46 does not need to be sterile when used on a patient. In one embodiment, the electronic orientation monitor housing 12 is a clamshell housing. The electronic orientation monitor housing 12 includes a body 24 for receiving the electronic orientation monitor 46, a lid 41, a loading funnel 37, and a locking device 80.

[0078] The clamshell-like shell 12 performs three main functions:

[0079] 1. Provide a physical barrier to prevent biocontamination of orientation monitors.

[0080] 2. Provide physical vibration isolation for the orientation monitor from high-level shocks, otherwise the orientation monitor will be subjected to high-level shocks during use.

[0081] 3. Maintain proper alignment of the orientation monitor. The accuracy of the orientation monitor is highly sensitive to any misalignment, therefore the clam shell has built-in alignment features to maintain proper alignment during use.

[0082] The clamshell-type shell 12 is preferably designed to be provided as a sterile, single-use component. Reusing the clamshell-type shell 12 may pose a safety risk to patients due to one or more of the following issues:

[0083] ■ Misalignment caused by wear and tear from repeated use;

[0084] ■ Misalignment caused by deformation due to cleaning or handling;

[0085] ■ Contamination caused by improper or inadequate re-disinfection can lead to infection.

[0086] The loading funnel 37 includes angled guide walls 38 and insertion walls 39. The loading funnel is sterile and prevents non-sterile parts from contacting the sterile parts of the electronic orientation monitor housing 12. The loading funnel is inserted into the electronic orientation monitor housing 12 to allow the insertion of an unsterilized electronic orientation monitor 46 into the housing 12. While inside the electronic orientation monitor housing 12, the unsterilized electronic orientation monitor 46 can be used in a sterile environment and can withstand forces applied to the housing 12, as will be discussed further below. The housing 12 also preferably includes one or more internal positioning features adapted to ensure proper alignment of the monitor 46 within the housing 12, thereby ensuring repeatable and accurate orientation measurements.

[0087] exist Figure 5A In the alternative embodiment shown, the loading funnel 37 is replaced by a transfer shield 60. The shield 60 is placed over the opening of the housing 12 to protect the sterile components of the housing 12, while the monitor 46 is inserted into the housing 12 through the shield 60. Figure 5 Compared to the loading funnel 37, the shield 60 provides better protection for the sterile components of the housing 12 during the insertion of the monitor 46. The housing 12 protects the navigation unit during use, providing shock isolation and a physical barrier against biocontamination.

[0088] The electronic orientation monitor housing 12 includes a body 24, a cap 41, a clip 42, and a clip lock 47 arranged to receive the clip 42 and the cap 41 and lock them in place to seal the body 24. The cap 41, clip 42, and clip lock 47 are part of a cover 43 of the electronic orientation monitor housing 12. The cap 41 pivots about its connection to the cover 43 to seal the body 24.

[0089] Locking device 80 extends from the base of electronic orientation monitor housing 12 to engage with docking station 19, thereby securing electronic orientation monitor 46 to reference device 100 to obtain reference orientation.

[0090] The locking device 80 includes a vertical extension member 25 extending perpendicularly from the body 24. A pair of front and rear vertical extension members 25 are provided, forming a square profile. A support frame member 26 extends between the front and rear vertical extension members 25 to form a closed frame. The vertical extension members 25 are attached to the body at an upper pivot point 45. This allows the vertical extension members 25 to rotate about the upper pivot point 45. The support frame member 26 is attached to the vertical extension members 25 using a lower pivot point 44. This allows the ends of the vertical extension members 25 to pivot about the support frame member 26. The attachment device is also adapted to engage with a mounting frame 90 including vibration isolation features to absorb forces applied longitudinally to the electronic orientation monitor housing 12, as will be described below. Isolation features in specific embodiments include those described below and as... Figure 5B The spring feature shown is 91.

[0091] The locking device 80's closed frame includes a central aperture 48, which is shaped to receive a docking station 19 to secure the electronic orientation monitor 46 to the reference device 100, thereby defining the orientation of the electronic orientation monitor 46 relative to the patient for further surgical procedures.

[0092] Figures 5A to 5C Another embodiment of the electronic monitor housing 12 is shown. In this embodiment, the angle of the housing 24 is set to a tilt angle by the mounting frame 90 to facilitate observation by surgeons and operating personnel. The mounting frame 90 is configured to precisely engage with the docking station 19 of the reference device 100. The spring feature 91 of the mounting frame 90 is used to isolate the orientation monitor housing 12 and the mounted orientation monitor 46 from environmental vibrations during operation, thereby improving the positional accuracy that the orientation monitor 46 can provide.

[0093] Figure 6 and Figure 7 Further views of the clamshell-like shell 12 disclosed above are shown. Figure 8A and 8B A clamshell-like housing 12 is shown engaging with the frame 70 of the reference device 100.

[0094] Please refer to Figure 9With the electronic orientation monitor 46 in a specific orientation, the electronic orientation monitor housing 12, to which the electronic orientation monitor 46 is inserted, is attached to the insertion device 52 having the acetabular cup 54. The surgeon manipulates the insertion device 52 to a position where the acetabular cup is adjacent to the patient's acetabulum, and a display (not shown) on the electronic orientation monitor 46 guides the surgeon to set the orientation of the insertion device such that the current orientation of the electronic orientation monitor 46 is equal to a reference orientation (or such that the current orientation has some other desired relationship with the reference orientation). The display provides the surgeon with position and orientation information, including yaw / tilt axis orientation and anteversion / pitch axis orientation, to allow the surgeon to precisely set the orientation of the repair tool according to the patient's unique anatomy. Depending on the surgeon's preference, the orientation monitor 46 can provide orientation information to the surgeon in a variety of different ways. For example, the orientation of the insertion device 52 relative to the patient's acetabulum can be communicated to the surgeon through a simple target display, where the degree to which the device 56 deviates from the target can be visually communicated. Other examples of orientation displays may include a "bubble level" visual display or a digital display provided according to the surgeon's personal preference.

[0095] When the desired orientation is achieved, the electronic orientation monitor 46 provides instructions to the surgeon, such as visual and / or audible instructions on a display, prompting the surgeon to assess the test cup or tap the impact plate 55 to transmit force through the shaft 53, thereby impacting the acetabular cup 54 into the patient's enlarged acetabulum.

[0096] When placed on the insertion device 52, the electronic orientation monitor housing 12 is arranged to isolate vibrations from the electronic orientation monitor 46. The vertical extension member 25 pivots about pivot points 44 and 45 to move the support frame member 26 forward or backward, thereby isolating the forces applied to the impact plate 55 from the electronic orientation monitor 46. Figure 5B The spring configuration 91 of the embodiment of housing 12 shown is particularly suitable for isolating the vibration of the insertion device during use.

[0097] As can be understood from the foregoing description, during the step of pressing the reference device to engage with the surgical drape and during the calibration of the electronic orientation monitor, the reference device 100 is configured to engage with the patient and the patient connection plate 18 on the patient only from the front. This is advantageous compared to the clamp disclosed in WO 2010 / 031111, which requires engagement with the patient from both the front and rear. This is because the inventors recognized that, in practical application, the clamp of WO 2010 / 031111 may cause undesirable obstruction to the surgeon.

[0098] Although the invention has been described with reference to specific examples, those skilled in the art will understand that the invention can be implemented in many other forms.

Claims

1. A reference device for use with a patient, the reference device comprising: Support plate; A first positioning element extending from the support plate; A second positioning element extending from the support plate; A third positioning element extending from the support plate; as well as An electronic orientation monitor housing suitable for receiving a surgical electronic orientation monitor, the surgical electronic orientation monitor being detachably coupled to the support plate and surgical instruments; The support plate can be used to perform measurements to calibrate the surgical electronic orientation monitor for subsequent use with the surgical instruments; A docking station adapted to receive the housing, thereby defining an external reference point relative to the patient's anatomical structure; The first, second, and third positioning elements are arranged to be pushed down onto the patient, thereby providing the electronic orientation monitor with a reference orientation relative to a predetermined anatomical location.

2. The reference device of claim 1, wherein the housing is a sterile housing.

3. The reference device of claim 2, wherein the housing comprises: The main body includes an opening adapted to receive an orientation monitor; The loading funnel includes angled guide walls and an insertion wall that allows an unsterilized orientation monitor to be inserted into a sterile housing while preventing contamination of the sterile housing. as well as Locking device, comprising: An enclosed frame adapted for engagement with a docking station, wherein the frame is pivotally attached to the body of the housing; and A central aperture, shaped to receive a docking station therein, thereby securing the orientation monitor to the reference device to define the orientation of the motorized orientation monitor relative to the patient.

4. The reference device of claim 3, wherein the loading funnel is a transfer shield adapted to be placed on the opening of the housing to protect the sterile components of the housing during use when the monitor is inserted into the housing through the shield.

5. The reference device of claim 3, wherein the locking device includes a central aperture shaped to receive a docking station therein. This fixes the orientation monitor to the reference device to define the orientation of the motorized orientation monitor relative to the patient.

6. The reference device as claimed in claim 1, wherein the housing is a clamshell-type housing.

7. The reference device of claim 1, wherein the first positioning element and the second positioning element are a first anterior superior iliac spine positioning element and a second anterior superior iliac spine positioning element.

8. The reference device as claimed in claim 1, wherein the third positioning element is a pubic bone positioning element.

9. The reference device of claim 1, wherein the first positioning element and the second positioning element comprise a patient connection plate.

10. The reference device of claim 9, wherein the patient connection plate is arranged to be fixed to the patient above the anterior superior iliac spine.

11. The reference device of claim 1, wherein the electronic orientation monitor is housed in an electronic orientation monitor housing.

12. The reference device of claim 10, wherein the electronic orientation monitor housing is arranged to engage with a support plate to provide a reference orientation for the electronic orientation monitor.

13. The reference device of claim 1, wherein the electronic orientation monitor is capable of docking with the docking station in either a first docking configuration or a second docking configuration.

14. The reference device as claimed in claim 13: The first docking configuration defines a first orientation of the electronic orientation monitor relative to the reference device; and The second docking configuration defines the second orientation of the electronic orientation monitor relative to the reference device.

15. The reference device of claim 1, wherein the electronic orientation monitor housing is adapted to provide a physical barrier against biocontamination of the orientation monitor.

16. The reference device of claim 1, wherein the electronic orientation monitor housing is adapted to provide physical vibration isolation of the orientation monitor from high-level shocks.

17. The reference device of claim 1, wherein the electronic orientation monitor housing is adapted to maintain the correct alignment of the orientation monitor relative to the patient's anatomy.

18. A method for calibrating an electronic orientation monitor using the reference device as described in claim 1, the method comprising the steps of: Position the patient connection plate on the left anterior superior iliac spine; Position the patient connection plate on the right anterior superior iliac spine; Connect the first positioning element and the second positioning element to the corresponding patient connection plate; Position the third positioning element against the pubic bone; An electronic orientation monitor is placed in the housing of a sterile electronic orientation monitor, the housing of which is configured to receive an unsterilized electronic orientation monitor while preventing contamination of the sterile housing. The housing containing the monitor is engaged to the docking station arranged on the reference device to take an external reference orientation relative to the patient; as well as Calibrate the electronic orientation monitor.

19. The method of claim 18, wherein the reference device is positioned in front of the patient during the step of positioning the patient connection plate and during the calibration of the electronic orientation monitor.

20. The method of claim 18, wherein, The anterior approach is used as the surgical access to the patient's acetabulum.

21. The method of claim 18, wherein the patient lies supine with face up during the step.

22. A method for calibrating an electronic orientation monitor using the reference device as described in claim 1, the method comprising the steps of: Place the surgical drape on the patient; Multiple positioning elements are engaged against the surgical drape, and the surgical drape is positioned between the multiple positioning elements and the corresponding multiple predetermined anatomical sites of the patient, thereby causing the docking station arranged on the reference device to adopt a reference orientation relative to the multiple predetermined anatomical sites. An electronic orientation monitor is placed in the housing of a sterile electronic orientation monitor and the housing is docked to a docking station to place the electronic orientation monitor in a reference orientation. The housing of the sterile electronic orientation monitor is configured to receive an unsterilized electronic orientation monitor while preventing contamination of the sterile housing. as well as Calibrate the electronic orientation monitor.

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