(19)
(11)EP 2 866 703 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
03.08.2022 Bulletin 2022/31

(21)Application number: 13808897.6

(22)Date of filing:  28.06.2013
(51)International Patent Classification (IPC): 
A61B 90/00(2016.01)
A61F 2/46(2006.01)
A61B 34/10(2016.01)
A61B 34/20(2016.01)
A61B 46/00(2016.01)
A61B 17/17(2006.01)
(52)Cooperative Patent Classification (CPC):
A61B 17/1746; A61B 2090/3983; A61B 2034/2048; A61B 2034/2068; A61B 2090/363; A61B 34/20; A61B 46/00; A61B 2090/0807; A61B 2034/107; A61B 90/37; A61F 2/4609
(86)International application number:
PCT/AU2013/000714
(87)International publication number:
WO 2014/000054 (03.01.2014 Gazette  2014/01)

(54)

A REFERENCING APPARATUS AND ASSOCIATED METHODS

REFERENZIERUNGSVORRICHTUNG UND ENTSPRECHENDE VERFAHREN

APPAREIL DE RÉFÉRENÇAGE ET PROCÉDÉS ASSOCIÉS


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 28.06.2012 AU 2012902750
12.04.2013 AU 2013204941

(43)Date of publication of application:
06.05.2015 Bulletin 2015/19

(73)Proprietor: Inertial Orthopaedic Navigation Solutions Pty Ltd
Brookvale, NSW 2100 (AU)

(72)Inventor:
  • LYE, Robert
    Brookvale, New South Wales 2100 (AU)

(74)Representative: Plasseraud IP 
235 Cours Lafayette
69006 Lyon
69006 Lyon (FR)


(56)References cited: : 
WO-A1-2010/031111
JP-A- 2004 089 653
US-A1- 2006 184 177
US-A1- 2012 022 406
WO-A2-2004/089192
US-A1- 2004 210 233
US-A1- 2010 174 415
US-A1- 2012 143 268
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Field of the Invention



    [0001] The present invention relates to surgical implements and surgical methods and in particular to a referencing apparatus that may be applied to a patient prior to, or during, surgical procedures, for example surgery involving prosthetic components.

    Background



    [0002] The discussion of the prior art within this specification is not, and should not be taken as, an admission of the extent of common general knowledge in the field of the invention. Rather, the discussion of the prior art is provided merely to assist the addressee to understand the invention and is included without prejudice.

    [0003] Whilst the following discussion is with respect to hip replacement surgery, a person skilled in the art will appreciate that the present invention is not limited to this particular field of use and may be adapted to use with any bone structure or various types of surgery.

    [0004] Hip replacement surgery involves the use of a prosthetic cup (acetabular cup) or a prosthetic ball (femoral stems) or both to restore the ball and cup joint functionality of the hip. The ball and cup joint enables the hip to rotate in different directions to various degrees (in contrast to the relatively limited rotation of a knee joint).

    [0005] Historically, hip replacement (arthroplasty) surgery required up to a 40cm (7 to 12 inches) curved incision to provide sufficient access for the surgeon to manually access and manipulate the hip and femur. A prosthetic cup was attached to the hip socket or the head of the femur 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 bones of the hip joint. It is typically this part of the surgery that makes the ligaments and muscles somewhat weak after surgery. Until they heal, which often takes about a month to six weeks, the patient must follow special hip precautions to prevent dislocation of the new hip joint,

    [0007] Typical steps in hip replacement surgery include the following;
    • Removing the Femoral Head: Once the hip joint is entered, the femoral head is dislocated from the acetabulum. Then the femoral head is removed by cutting through the femoral neck with a power saw.
    • Reaming the Acetabulum; After the femoral head is removed, the cartilage is removed from the acetabulum using a power drill and a special reamer. The reamer forms the bone in a hemispherical shape to exactly fit the metal shell of the acetabular component.
    • Inserting the Acetabular Component: A trial component, which is an exact duplicate of the patient's hip prosthesis, is used to ensure that the joint received will be the right size and fit. Once the right size and shape is determined for the acetabulum, the acetabular component is inserted into place. In the uncomented variety of artificial hip replacement, the metal shell is simply held in place by the tightness of the fit or with screws to hold the metal shell in place, In the cemented variety, a special epoxy type cement is used to "glue" the acetabular component to the bone.
    • Preparing the Femoral Canal: To begin replacing the femoral head, special rasps are used to shape and hollow out the femur to the exact shape of the metal stein of the femoral component. Once again, a trial component is used to ensure the correct size and shape. The surgeon will also test the movement, of the hip joint.
    • Inserting the Femoral Stem: Once the size and shape of the canal exactly fit the femoral component, the stem is inserted into the femoral canal. Again, in the uncemented variety of femoral component the stem is held in place by the tightness of the fit into the bone (similar to the friction that holds a nail driven into a hole drilled into wooden board - with a slightly smaller diameter than the nail). In the cemented variety, the femoral canal is rasped to a size slightly larger than the femoral stem. Then the epoxy type cement is used to bond the metal stem to the bone.
    • Attaching the Femoral Head; The metal ball that replaces the femoral head is attached to the femoral stem.
    • The Completed Hip Replacement: Before the incision is closed, an x-ray is taken to make sure the new prosthesis is in the correct position.


    [0008] Such surgery had a number of problems including:

    ▪ a hospital stay of three days or more, post-operative pain and weeks of rehabilitation;

    ▪ each cm of incision has a tenfold increase in the risks of blood clotting and infection post surgery;

    ▪ the surgeon was reliant on his experience and eye to ensure accurate placement of the cup into the three dimensional hip socket and alignment of the cup with the ball/femur to enable proper function of the joint. Misalignment may lead to post operative complication such as misalignment of the leg, incorrect leg length and/or incorrect soft tissue tension. The long term effects of misaligned prosthetic components can also include accelerated wear of the components, aseptic loosening of the components and potentially early repetition of the surgery.



    [0009] Attempts to overcome these problems include:

    WO 2003/037192 which discloses a jib (impaction tool) for use in bone surgery and thus enables the use of a smaller incision. For hip replacement surgery, the jig enables the use of a 4 to 7 cm (2 to 3 inch) incision, i.e. keyhole surgery. Other benefits include a shorter stay in hospital, less blood loss, less pain, fewer postoperative dislocations and faster recovery; and

    WO 2005/046475 which discloses a gauge to assist the surgeon with accurate placement of a prosthetic when using a jig in keyhole surgery as the surgeon is no longer able to see the fit of the cup into the hip socket or the fit between the ball and cup.



    [0010] The gauge provided in WO 2005/046475 has enabled efficient use of the impaction tool of WO 2003/037192. Commercial examples include the NilNav Hip System available from MAC Surgical. However, the gauge only works in two dimensions and there is still a heavy reliance on the surgeon's eye and experience for optimal placement of the cup into the hip.

    [0011] A further attempt to overcome these problems was provided by WO 2010/031111. This prior art document discloses a brace (3) in the form of a clamp that is attachable to a patient to define a reference point relative to the patient's anatomy. This prior art clamp has a number of pads (14, 16, 17 and 18) that are positioned against various points of the patent's anatomy. However, it has been appreciated by the present inventor that this clamp is likely to be obstructive to at least some surgical procedures and does not readily accommodate the surgical drapes.

    [0012] US 2012/143268 A1 discloses a surgical guidance system for properly orienting a surgical instrument, such as an acetabular cup inserter, within a patient relative to a plurality of anatomical reference points and includes a support device for retaining the patient, a reference sensor fixedly coupled to the support device and a tool sensor removably coupled to the instrument.

    [0013] Further examples of an anatomical locator implemented in orthopedic surgery are disclosed in WO-A-2004/089192 and US-A-2012/022406.

    Summary of the Invention



    [0014] The invention is defined by the appended claims.

    [0015] According to a first aspect of the invention there is provided a referencing apparatus, as defined by claim 1, for application onto a patient at least partially covered by surgical drapes.

    [0016] According to a second aspect of the invention there is provided a method of using a referencing apparatus as described above to calibrate an electronic orientation monitor, the method including the steps of:

    positioning surgical drapes onto a patient;

    engaging the plurality of locating elements against the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements and a respective plurality of predefined anatomical sites on the patient so as to cause a docking station disposed on the referencing apparatus to assume a reference orientation relative to the plurality of predefined anatomical sites;

    docking the electronic orientation monitor with the docking station so as to orient the electronic orientation monitor in a reference orientation; and

    calibrating the electronic orientation monitor.



    [0017] According to a third aspect, not forming part of the invention, there is provided a method of using a referencing apparatus as an aid in the insertion of a prosthetic component into an acetabulum of a patient's pelvis, the method including the steps of:

    providing a referencing apparatus having first, second and third locating elements;

    positioning surgical drapes onto the patient;

    pressing the referencing apparatus into engagement with the surgical drapes such that the surgical drapes are disposed intermediate the first locating element and a right hand anterior superior iliac spine of the patient and such that the surgical drapes are disposed intermediate the second locating element and a pubic crest of the patient and such that the surgical drapes are disposed intermediate the third locating element and a left hand anterior superior iliac spine of the patient so as to cause a docking station disposed on the referencing apparatus to assume a reference orientation relative to the patient's pelvis;

    docking an electronic orientation monitor with the docking station so as to orient the electronic orientation monitor in a reference orientation and calibrating the electronic orientation monitor;

    attaching the electronic orientation monitor to an insertion implement having the prosthetic component disposed thereon;

    manipulating an insertion implement into a position whereby the prosthetic component is adjacent the acetabulum; and

    using the electronic orientation monitor to guide an orientation of the insertion implement such that an orientation of the electronic orientation monitor assumes a predefined relationship to the reference orientation; and

    inserting the prosthetic component into the acetabulum.



    [0018] Preferably the referencing apparatus is disposed anterior to the patient during the steps of pressing the referencing apparatus into engagement with the surgical drapes and during calibration of the electronic orientation monitor.

    [0019] Preferably an anterior approach is used for surgical access to the patent's acetabulum and the patient lies in a face up position during the method's steps.

    Brief Description of the Drawings



    [0020] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

    Figure 1 is a top side perspective view of an embodiment of the referencing apparatus according to the invention;

    Figure 2 is a left hand side perspective view of the embodiment of Figure 1;

    Figure 3 is a underside perspective view of an embodiment of an electronic orientation monitor for use with the brace of Figure 1;

    Figure 4 is another underside perspective view of the embodiment of Figure 3;

    Figure 5 is a detail partial perspective view of the docking station of the embodiment of Figure 1;

    Figure 6 is a detail partial perspective view of the electronic orientation monitor of Figure 3 as attached to the docking station of the brace of Figure 1;

    Figure 7 is a top side perspective view of the electronic orientation monitor of Figure 3 as attached to the docking station of the brace of Figure 1; and

    Figure 8 is a side perspective view of the electronic orientation monitor of Figure 3 as attached to the docking station of the brace of Figure 1.


    Detailed Description of the Preferred Embodiments



    [0021] Referring to the drawings, the referencing apparatus 1 is for application onto a patient at least partially covered by surgical drapes. Typically the patient lies on the surgical table in a face up position (i.e. the patient lies on his or her back). The surgical drapes are positioned on the patient prior to the surgery so as to cover the general region of the patient that is proposed to be operated upon, with an aperture in the drapes being positioned over the proposed site of the surgical incision. In some instances a surgeon may decide against the use of surgical drapes, in which case alternatives, such as cling film for example, may be used instead. The scope of the term "drapes" as used in this patent specification, including in the claims, is to be construed sufficiently broadly so as to include such alternatives

    [0022] This detailed description shall describe the use of the referencing apparatus 1 as an aid in the insertion of a prosthetic component in the form of an acetabular cup, into a reamed acetabulum of a patient's pelvis wherein an anterior approach is used for surgical access to the patent's acetabulum. An important part of this process is the use of the referencing apparatus 1 to calibrate an electronic orientation monitor, which may be as per that disclosed in WO 2010/031111.

    [0023] However it will be appreciated by those skilled in the art that the invention may be used in other surgical contexts.

    [0024] The referencing apparatus 1 has a 'T'-shaped frame 8 with a docking station 9 disposed at the intersection of the 'T' shape. The frame 8 defines two slots 10 and 11 disposed adjacent two of the extremities of the 'T' shape. Each of the slots 10 and 11 has a length of between 60 mm and 120 mm and in one embodiment each of their lengths is 70mm and in another embodiment each of their lengths is 100mm.

    [0025] The referencing apparatus 1 has three locating elements, which are each in the shape of circular loops 2, 3 and 4. Each of the loops 2, 3 and 4 has a diameter of between 30 mm and 70 mm and in the illustrated embodiment this diameter is 50 mm. As will be described in more detail below, each of these loops 2, 3 and 4 is sized to receive a projection of the surgical drapes caused by engagement with an anatomical site.

    [0026] The first and third loops 2 and 4 are each attached to respective distal ends of arcuate members 5 and 6. The radius of curvature of each of the arcuate members 5 and 6 is between 40 mm and 80 mm and is 60mm in the illustrated embodiment. The curvature of members 5 and 6 provides clearance for situations in which the referencing apparatus 1 is to be used on an overweight or obese patient having stomach fat deposits that would foul against the members 5 and 6 if they were straight. The proximal end of arcuate member 5 is attachable to the frame 8 at slot 10.

    [0027] The proximal end of arcuate member 6 is attachable to the frame 8 at the extremity of the 'T' shaped frame 8 that does not have a slot 10 or 11. Rather, an aperture is disposed adjacent this extremity, through which the proximal end of arcuate member 6 extends. Screw threads extending to flanges 14 and 15 are respectively provided on the proximal ends of the arcuate members 5 and 6. Screwing threaded fasteners 12 and 13 respectively onto the proximal ends of arcuate members 5 and 6 causes flanges 14 and 15 to engage against the lower side of the frame 8 so as to provide a clamping action that attaches the arcuate members 5 and 6 onto the frame 8.

    [0028] If the user wishes to adjust the position of the first loop 2 relative to the frame 8, it is merely necessary to loosen the threaded fastener 12, then slide the proximal end of arcuate member 5 along slot 10 until the loop 2 is in the desired position, and then retighten the threaded fastener 12. This adjustability of the attachment position of the arcuate member 5 on the frame 8 allows the separation distance between loops 2 and 4 to be adjusted to match the separation distance between the patient's left anterior superior iliac spine and the patient's right anterior superior iliac spine.

    [0029] It will be appreciated that loosening of threaded fastener 12 also allows for rotation of arcuate member 5 about an axis of rotation that is orthogonal to the upper surface of the frame 8. Hence, if the user wishes to adjust the position of the clearance provided by the curvature of arcuate member 5, then the user merely loosens threaded fastener 12, rotates arcuate member 5 until the curvature is in the desired position and then retightens threaded fastener 12. Doing so does not re-position the loop 2 relative to the frame 8 because the centre of loop 2 is in axial alignment with the axis of rotation of the arcuate member 5. Similarly, it is possible to adjust the position of the clearance provided by the curvature of arcuate member 6 by loosening threaded member 13, rotating arcuate member 6, then re-tightening threaded member 13. This does not reposition loop 4 because its centre is in axial alignment with the axis of rotation of the arcuate member 6.

    [0030] The second loop 3 is attached to the distal end of a linear elongate member 7. The proximal end of member 7 is attachable to the frame 8 at slot 11. A screw thread extending to a flange 16 is provided on the proximal end of member 7. This allows a threaded fastener 17 to be screwed onto the proximal end of meniber7 to thereby cause flange 16 to engage against the lower side of the frame 8 so as to clamp the member 7 onto the frame 8. The position of the second loop 3 can be adjusted by loosening threaded fastener 17, then sliding the proximal end of member 7 along slot 11 until loop 3 is in the desired position and then re-tightening threaded fastener 17. In other words, the adjustability given by slots 10 and 11 allows the referencing apparatus 1 to be used on patient's having variously sized pelvises.

    [0031] The shape of each of the loops 2, 3 and 4 allows for engagement with the surgical drapes such that the surgical drapes are disposed intermediate the three loops and three respective predefined anatomical sites on the patient. In use, the surgeon and/or an assistant uses their fingers to apply pressure to the surgical drapes to feel for the approximate positions of the predefined anatomical sites, which are the patient's left and right anterior superior iliac spine and the patient's pubic crest. It has been appreciated by the inventor that these anatomical sites may be readily discerned through the surgical drapes in this manner. Once these approximate positions are known the first loop 2 is positioned on the surgical drapes centred above the patient's right hand anterior superior iliac spine. The second loop 3 is positioned on the surgical drapes centred above the patient's pubic crest and the third loop 4 is positioned on the surgical drapes centred above the patient's left hand anterior superior iliac spine.

    [0032] Once the referencing apparatus 1 is positioned as described in the preceding paragraph the surgeon and/or an assistant presses the referencing apparatus 1 into engagement with the surgical drapes. The anatomical sites have bony projections that become more prominent when the loops 2, and 3 and 4 are pressed against them, This causes the surgical drapes at those sites to project into the cavities defined by the interior of each of the loops 2, 3 and 4, This engagement causes the docking station 9 to assume a reference orientation relative to the three predefined anatomical sites.

    [0033] As best shown in Figure 3, the electronic orientation monitor 18 has a shaft 19 disposed on its underside 20 such that the shaft 19 extends from the underside 20 at an angle that is matched to a desired anteversion of the acetabular cup. In the illustrated embodiment this angle is 15°, although this may vary depending upon the patient's anatomy, the surgeon's preferences and/or upon the type of prosthetic acetabular cup that is to be used. If another anteversion angle is desired, then a different shaft having the desired angle may be affixed to the electronic orientation monitor 18. The shaft 19 is sized so as to mate with one of two possible holes 21 or 22 provided within the docking station 9. The shape and geometry of each hole 21 and 22 is such that each of them presents only one option for entry of the shaft 19. The orientations of the holes 21 and 22 are selected such that the holes correspond to the orientation of the shaft of a prosthetic insertion implement that is to be used during the subsequent insertion steps that are described in more detail below.

    [0034] The angles at which the first and second holes 21 and 22 are drilled into the docking station 9 are selected as to match a desired inclination of the acetabular cup. In the illustrated embodiment this angle is 40°, although this may vary depending upon the patient's anatomy, the surgeon's preferences and/or upon the type of prosthetic acetabular cup that is to be used.

    [0035] Mating the shaft with the first hole 21 provides a first docking configuration, as shown for example in Figure 7. In the first docking configuration the orientation of the electronic orientation monitor 18 relative to the frame 8 is such that when the docking station 9 is in the reference orientation, the electronic orientation monitor 18 may be calibrated to a reference orientation that is suitable for insertion of an acetabular cup into the patient's left hand side acetabulum. Mating the shaft with the second hole 22 provides a second docking configuration, as shown for example in Figure 6. In the second docking configuration the orientation of the electronic orientation monitor 18 relative to the frame 8 is such that when the docking station 9 is in the reference orientation, the electronic orientation monitor 18 may be calibrated to a reference orientation that is suitable for insertion of an acetabular cup into the patient's right hand side acetabulum.

    [0036] The shaft 19 includes a pin 23, which functions as a stop when the shaft 19 is fully inserted into either the first hole 21 or the second hole 22. Additionally, the shaft 19 includes two ball bearing detents 24 and 25, which releasably retain the shaft 19 within the selected first or second hole 21 or 22 once it has been fully inserted.

    [0037] As mentioned above, pushing the referencing apparatus 1 into engagement with the drapes on the patient causes the docking station 9 to assume the reference orientation relative to the patient's pelvis and hence the docked electronic orientation monitor 18 is in a reference orientation. Whilst in this state the user presses the calibration button 26, which prompts the electronic orientation monitor 18 to sense its current orientation. Data indicative of this reference orientation is stored within the memory of the electronic orientation monitor 18, which has now been calibrated and may be detached from the referencing apparatus 1. Additionally, the referencing apparatus 1 is now removed from the patient.

    [0038] The electronic orientation monitor 18 is now attached to an insertion implement having either a trial acetabular cup, or the definitive acetabular cup. One such implement is disclosed in WO 2010/031111, however it will be appreciated that any suitable implement may be used. The surgeon manipulates the insertion implement into a position whereby the cup is adjacent the acetabulum and a display 27 on the electronic orientation monitor 18 guides the surgeon to orient the insertion implement such that the current orientation of the electronic orientation monitor 18 is equal to the reference orientation (or such that the current orientation has some other desired relationship to the reference orientation). Once the desired orientation has been achieved, the electronic orientation monitor 18 provides an indication to the surgeon, such as a visual indication on the display and/or an audible indication, and this prompts the surgeon to either assess the trial cup, or to impact the definitive cup into the patient's reamed acetabulum.

    [0039] From the foregoing description it will be appreciated that the referencing apparatus 1 is configured for solely anterior engagement with the drapes that are on the patient during the steps of pressing the referencing apparatus into engagement with the surgical drapes and during calibration of the electronic orientation monitor. This compares favourably with the clamp disclosed in WO 2010/031111, which requires both anterior and posterior engagement with the patient. This is because it has been appreciated by the present inventor that in practice the clamp of WO 2010/031111 may cause an undesirable obstruction to the surgeon.

    [0040] Whilst the invention has been described with reference to specific examples, those skilled in the art will appreciate that it may be embodied in many other forms.


    Claims

    1. A referencing apparatus (1) for application onto a patient at least partially covered by surgical drapes, the referencing apparatus comprising:

    a 'T' shaped frame (8) comprising three elongate members (5, 6, 7) respectively attachable adjacent three extremities of the frame;

    a plurality of locating elements (2, 3, 4), each locating element (2,3,4) attached to a distal end of respective elongate members (5, 6, 7), and shaped for engagement with the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements (2, 3, 4) and a respective plurality of predefined anatomical sites on the pelvis of the patient, each of said locating elements (2, 3, 4) being a circular loop having an interior defining a cavity;

    a proximal end of each elongate member (5, 6, 7) is attachable to the frame (8), and

    a docking station (9) coupled to an upper surface of said frame (8), and having an upstanding side perpendicular to the upper surface of the frame (8) and including first (21) and second (22) holes extending therein at different orientations relative to each other, and, whereby, in use, the apparatus (1) is shaped such that coupling of the docking station to the upper surface of the frame causes the docking station to assume a reference orientation relative to the plurality of predefined anatomical sites, wherein at least one of the cavities of the locating-elements is sized to receive a projection of the surgical drapes caused by the respective anatomical site;

    an electronic orientation monitor (18) having a shaft (19);

    characterized in that the first hole (21) has an inclination arranged to match a desired inclination for an acetabular cup that is for insertion into the patient's left hand side acetabulum and the second hole (22) has an inclination arranged to match a desired inclination for an acetabular cup that is for insertion in the patient's right hand side acetabulum, and

    wherein the first and second holes (21, 22) are sized and shaped to receive the shaft (19) of the electronic orientation monitor (18).


     
    2. A referencing apparatus (1) according to Claim 1, wherein at least one of the elongate members is an arcuate member (5, 6), wherein at least one of the loops is attached to the arcuate member (5, 6) and wherein the arcuate member (5, 6) is attachable to the frame (8) of the referencing apparatus (1).
     
    3. A referencing apparatus (1) according to Claim 2, wherein the at least one loop attached to the arcuate member (5, 6) defines a centre that is in axial alignment with an axis of rotation of the arcuate member (5, 6) to which it is attached.
     
    4. A referencing apparatus (1) according to Claim 2 or 3, wherein the arcuate member (5) is attachable to a slot (10) disposed within the frame (8) such that an attachment position of the arcuate member (5, 6) to the frame (8) is selectively adjustable.
     
    5. A referencing apparatus (1) according to Claim 4, wherein the arcuate member (5) is attachable to the slot (10) by a clamping action provided by a threaded fastener (12).
     
    6. A referencing apparatus (1) according to any one of Claims 2 to 5, wherein the docking station (9) is disposed substantially at an intersection of the 'T shape.
     
    7. A referencing apparatus (1) according to Claim 6, wherein at least two of the elongate members are arcuate members (5, 6).
     
    8. A referencing apparatus (1) according to any one of the preceding claims, wherein the electronic orientation monitor (18) is dockable with the docking station (9) in either a first docking configuration or a second docking configuration.
     
    9. A referencing apparatus (1) according to Claim 8, wherein the first docking configuration defines a first orientation of the electronic orientation monitor (18) relative to the referencing apparatus (1) and wherein the second docking configuration defines a second orientation of the electronic orientation monitor (18) relative to the referencing apparatus (1).
     
    10. A referencing apparatus (1) according to Claim 8 or 9, wherein the first and second docking configurations are respectively defined by the first and second holes (21, 22).
     
    11. A method of using a referencing apparatus (1) as defined in Claim 1, calibrate an electronic orientation monitor (18), the method including the steps of:

    positioning surgical drapes onto a patient;

    engaging the plurality of locating elements (2, 3, 4) against the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements (2, 3, 4) and a respective plurality of predefined anatomical sites on the patient so as to 46 cause a docking station (9) disposed on the referencing apparatus (1) to assume a reference orientation relative to the plurality of predefined anatomical sites;

    docking the electronic orientation monitor (18) with the docking station (9) so as to orient the electronic orientation monitor (18) in a reference orientation; and

    calibrating the electronic orientation monitor (18).


     


    Ansprüche

    1. Referenzierungsvorrichtung (1) zur Anwendung bei einem Patienten, der zumindest teilweise von Operationsabdecktüchern bedeckt ist, wobei die Referenzierungsvorrichtung Folgendes umfasst:

    einen 'T'-förmigen Rahmen (8), umfassend drei längliche Elemente (5, 6, 7), die jeweils an drei äußersten Enden des Rahmens befestigbar sind;

    eine Vielzahl von Positionierungselementen (2, 3, 4), wobei jedes Positionierungselement (2, 3, 4) an einem distalen Ende entsprechender länglicher Elemente (5, 6, 7) befestigt ist und für den Eingriff mit den Operationsabdecktüchern so geformt ist, dass die Operationsabdecktücher zwischen der Vielzahl von Positionierungselementen (2, 3, 4) und einer entsprechenden Vielzahl von vordefinierten anatomischen Stellen am Becken des Patienten angeordnet sind, wobei jedes der Positionierungselemente (2, 3, 4) eine kreisförmige Schlaufe ist, deren Inneres einen Hohlraum definiert;

    ein proximales Ende jedes länglichen Elements (5, 6, 7), das an dem Rahmen (8) befestigbar ist, und

    eine Andockstation (9), die mit der oberen Fläche des Rahmens (8) gekoppelt ist und eine aufrechte Seite senkrecht zu der oberen Fläche des Rahmens (8) aufweist und erste (21) und zweite (22) Öffnungen beinhaltet, die sich darin in unterschiedlichen Ausrichtungen relativ zueinander erstrecken, und wobei die Vorrichtung (1) im Gebrauch so geformt ist, dass das Koppeln der Andockstation mit der oberen Fläche des Rahmens bewirkt, dass die Andockstation eine Referenzausrichtung in Bezug auf die Vielzahl von vordefinierten anatomischen Stellen einnimmt, wobei zumindest einer der Hohlräume der Positionierungselemente zur Aufnahme einer durch die jeweilige anatomische Stelle verursachten Projektion der Operationsabdecktücher bemessen ist;

    einen elektronischen Ausrichtungsmonitor (18), der einen Schaft (19) aufweist;

    dadurch gekennzeichnet, dass die erste Öffnung (21) eine Neigung aufweist, die so angeordnet ist, dass sie einer gewünschten Neigung für eine Hüftgelenkspfanne entspricht, die in das linksseitige Acetabulum des Patienten eingesetzt werden soll, und die zweite Öffnung (22) eine Neigung aufweist, die so angeordnet ist, dass sie einer gewünschten Neigung für eine Hüftgelenkspfanne entspricht, die in das rechtsseitige Acetabulum des Patienten eingesetzt werden soll, und

    wobei die erste und zweite Öffnung (21, 22) zur Aufnahme eines Schafts (19) eines elektronischen Ausrichtungsmonitors (18) dimensioniert und geformt sind.


     
    2. Referenzierungsvorrichtung (1) nach Anspruch 1, wobei zumindest eines der länglichen Elemente ein bogenförmiges Element (5, 6) ist, wobei zumindest eine der Schlaufen an dem bogenförmigen Element (5, 6) befestigt ist und wobei das bogenförmige Element (5, 6) an dem Rahmen (8) der Referenzierungsvorrichtung (1) befestigbar ist.
     
    3. Referenzierungsvorrichtung (1) nach Anspruch 2, wobei die zumindest eine an dem bogenförmigen Element (5, 6) befestigte Schlaufe ein Zentrum definiert, das axial mit einer Drehachse des bogenförmigen Elements (5, 6), an dem sie befestigt ist, ausgerichtet ist.
     
    4. Referenzierungsvorrichtung (1) nach Anspruch 2 oder 3, wobei das bogenförmige Element (5) an einem in dem Rahmen (8) angeordneten Schlitz (10) befestigbar ist, so dass eine Befestigungsposition des bogenförmigen Elements (5, 6) an dem Rahmen (8) selektiv einstellbar ist.
     
    5. Referenzierungsvorrichtung (1) nach Anspruch 4, wobei das bogenförmige Element (5) durch eine Klemmwirkung, die durch ein mit einem Gewinde versehenen Befestigungselement (12) bereitgestellt wird, an dem Schlitz (10) befestigbar ist.
     
    6. Referenzierungsvorrichtung (1) nach einem der Ansprüche 2 bis 5, wobei die Andockstation (9) im Wesentlichen an einem Schnittpunkt der 'T'-Form angeordnet ist.
     
    7. Referenzierungsvorrichtung (1) nach Anspruch 6, wobei zumindest zwei der länglichen Elemente bogenförmige Elemente (5, 6) sind.
     
    8. Referenzierungsvorrichtung (1) nach einem der vorhergehenden Ansprüche, wobei der elektronische Ausrichtungsmonitor (18) entweder in einer ersten Andockkonfiguration oder in einer zweiten Andockkonfiguration an die Andockstation (9) andockbar ist.
     
    9. Referenzierungsvorrichtung (1) nach Anspruch 8, wobei die erste Andockkonfiguration eine erste Ausrichtung des elektronischen Ausrichtungsmonitors (18) relativ zu der Referenzierungsvorrichtung (1) definiert und wobei die zweite Andockkonfiguration eine zweite Ausrichtung des elektronischen Ausrichtungsmonitors (18) relativ zu der Referenzierungsvorrichtung (1) definiert.
     
    10. Referenzierungsvorrichtung (1) nach Anspruch 8 oder 9, wobei die erste und zweite Andockkonfiguration jeweils durch die erste und zweite Öffnung (21, 22) definiert sind.
     
    11. Verfahren zur Verwendung einer Referenzierungsvorrichtung (1), wie in Anspruch 1 definiert, zum Kalibrieren eines elektronischen Ausrichtungsmonitors (18), wobei das Verfahren die folgenden Schritte umfasst:

    Positionieren von Operationsabdecktüchern auf einem Patienten;

    Ineinandergreifen der Vielzahl von Positionierungselementen (2, 3, 4) mit den Operationsabdecktüchern, sodass die Operationsabdecktücher zwischen der Vielzahl von Positionierungselementen (2, 3, 4) und einer entsprechenden Vielzahl von vordefinierten anatomischen Stellen an dem Patienten angeordnet sind, um zu bewirken, dass eine an der Referenzierungsvorrichtung (1) angeordnete Andockstation (9) eine Referenzausrichtung relativ zu der Vielzahl von vordefinierten anatomischen Stellen einnimmt;

    Andocken des elektronischen Ausrichtungsmonitors (18) an die Andockstation (9), um den elektronischen Ausrichtungsmonitor (18) in einer Referenzausrichtung auszurichten; und

    Kalibrieren des elektronischen Ausrichtungsmonitors (18).


     


    Revendications

    1. Appareil de référencement (1) pour une application sur un patient au moins partiellement recouvert par des champs opératoires, l'appareil de référencement comprenant :

    un cadre (8) en forme de T comprenant trois éléments allongés (5, 6, 7) pouvant être respectivement attachés adjacents à trois extrémités du cadre ;

    une pluralité d'éléments de positionnement (2, 3, 4), chaque élément de positionnement (2, 3, 4) étant attaché à une extrémité distale d'éléments allongés (5, 6, 7) respectifs, et étant mis en forme pour venir en prise avec les champs opératoires de sorte que les champs opératoires soient disposés entre la pluralité d'éléments de positionnement (2, 3, 4) et une pluralité respective de sites anatomiques prédéfinis sur le bassin du patient, chacun desdits éléments de positionnement (2, 3, 4) étant une boucle circulaire ayant un intérieur définissant une cavité ;

    une extrémité proximale de chaque élément allongé (5, 6, 7) peut être attachée au cadre (8), et

    une station d'accueil (9) couplée à la surface supérieure dudit cadre (8), et ayant un côté vertical perpendiculaire à la surface haute du cadre (8) et comportant des premier (21) et deuxième (22) trous s'étendant en son sein selon des orientations différentes l'un par rapport à l'autre, et, moyennant quoi, en utilisation, l'appareil (1) est mis en forme de sorte que le couplage de la station d'accueil à la surface supérieure du cadre amène la station d'accueil à prendre une orientation de référence par rapport à la pluralité de sites anatomiques prédéfinis, dans lequel au moins l'une des cavités des éléments de positionnement est dimensionnée pour recevoir une saillie des champs opératoires provoquée par le site anatomique respectif ;

    un moniteur d'orientation électronique (18) ayant une tige (19) ;

    caractérisé en ce que le premier trou (21) a une inclinaison agencée pour concorder avec une inclinaison souhaitée pour un cotyle qui est destiné à une insertion dans la cavité cotyloïde gauche du patient et le deuxième trou (22) a une inclinaison agencée pour concorder avec à une inclinaison souhaitée pour un cotyle qui est destiné à une insertion dans la cavité cotyloïde droite du patient, et

    dans lequel les premier et deuxième trous (21, 22) sont dimensionnés et mis en forme pour recevoir une tige (19) d'un moniteur d'orientation électronique (18).


     
    2. Appareil de référencement (1) selon la revendication 1, dans lequel au moins l'un des éléments allongés est un élément arqué (5, 6), dans lequel au moins l'une des boucles est attachée à l'élément arqué (5, 6) et l'élément arqué (5, 6) peut être attaché au cadre (8) de l'appareil de référencement (1).
     
    3. Appareil de référencement (1) selon la revendication 2, dans lequel l'au moins une boucle attachée à l'élément arqué (5, 6) définit un centre qui est en alignement axial avec un axe de rotation de l'élément arqué (5, 6) auquel elle est attachée.
     
    4. Appareil de référencement (1) selon la revendication 2 ou 3, dans lequel l'élément arqué (5) peut être attaché à une fente (10) disposée au sein du cadre (8) de sorte qu'une position d'attache de l'élément arqué (5, 6) au cadre (8) soit sélectivement réglable.
     
    5. Appareil de référencement (1) selon la revendication 4, dans lequel l'élément arqué (5) peut être attaché à la fente (10) par une action de serrage fournie par un élément de fixation fileté (12) .
     
    6. Appareil de référencement (1) selon l'une quelconque des revendications 2 à 5, dans lequel la station d'accueil (9) est disposée sensiblement au niveau d'une intersection de la forme en T.
     
    7. Appareil de référencement (1) selon la revendication 6, dans lequel au moins deux des éléments allongés sont des éléments arqués (5, 6).
     
    8. Appareil de référencement (1) selon l'une quelconque des revendications précédentes, dans lequel le moniteur d'orientation électronique (18) peut être accueilli sur la station d'accueil (9) soit dans une première configuration d'accueil, soit dans une deuxième configuration d'accueil.
     
    9. Appareil de référencement (1) selon la revendication 8, dans lequel la première configuration d'accueil définit une première orientation du moniteur d'orientation électronique (18) par rapport à l'appareil de référencement (1) et dans lequel la deuxième configuration d'accueil définit une deuxième orientation du moniteur d'orientation électronique (18) par rapport à l'appareil de référencement (1).
     
    10. Appareil de référencement (1) selon la revendication 8 ou 9, dans lequel les première et deuxième configurations d'accueil sont respectivement définies par les premier et deuxième trous (21, 22) .
     
    11. Procédé d'utilisation d'un appareil de référencement (1) tel que défini dans la revendication 1pour étalonner un moniteur d'orientation électronique (18), le procédé comportant les étapes consistant à :

    positionner des champs opératoires sur un patient ;

    mettre en prise la pluralité d'éléments de positionnement (2, 3, 4) contre les champs opératoires de sorte que les champs opératoires soient disposés entre la pluralité d'éléments de positionnement (2, 3, 4) et une pluralité respective de sites anatomiques prédéfinis sur le patient de manière à amener une station d'accueil (9) disposée sur l'appareil de référencement (1) à prendre une orientation de référence par rapport à la pluralité de sites anatomiques prédéfinis ;

    accueillir le moniteur d'orientation électronique (18) sur la station d'accueil (9) de manière à orienter le moniteur d'orientation électronique (18) dans une orientation de référence ; et

    étalonner le moniteur d'orientation électronique (18).


     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description