Seating implants with an appropriate degree of interference and avoiding high bone stress or fracture can be a challenge.
Specific examples of optical measurement systems will now be described with reference to the accompanying drawings, in which:
Referring to
The processor 112 can be configurable with software 116 for processing the input data 106 and for generating the output data 110.
In the example depicted in
The images 106a-d are of a subject. In the example depicted, the subject is a body part 122. The body part is, in the example shown, a bone such as, for example, a femoral bone or femur. The body part is an example of a target tissue. More specially, the body part can be of the proximal end of the shaft of the femur into which an implant 124 can be seated. In the example depicted, the implant 124 is a femoral prosthesis comprising a femoral head and a femoral stem.
The body part 122 is arranged to bear a reference or indicium 126. Examples can be realized in which the reference or indicium 126 comprises, for example, a speckle pattern, which is described with reference to
The processor 112 and software 116 are arranged to receive and to store in the memory 114 a reference image 128 and a temporally subsequent image 130 selected from the images 106a-d. The reference image 128 comprises a representation 132 of the reference or indicium 126. The subsequent image 128 comprises a representation 134 of the reference or indicium 126. The reference image 128 is taken at a time t1. The subsequent image 130 is taken at a later time t2. The subsequent image 130 is taken during seating the implant 124. It can be seen that the representations 132 and 134 of the reference or indicium 126 are different. In the example depicted, the representation 134 in the subsequent image 130 has an expanded state compared to the representation 132 in the reference image 128.
The processor 112 and software 116 are arranged to compare the reference image 128 and the subsequent image 130 to identify any differences in the reference or indicium 126. The identified differences are used to determine a physical characteristic associated with the body part 122. In the example depicted, the physical characteristic is the strain to which the body part 122 is subjected as a consequence of inserting the implant 124 or the implant 124 having been inserted. For example, the femoral stem of a femoral prosthesis can rely on a frictional fit to remain seated within the femur. The process of seating the femoral prosthesis, and the femoral prosthesis being seated, expands the proximal end of the shaft of the femur.
Once a strain measurement has been determined, the output data 110 representing that strain measurement is output via the output interface 108. The output data 110 can be output for further processing. Alternatively, or additionally, the output data 110 can be output for display on a display 136. The displayed output data 110 comprises data 138 representing the determined strain measurement. A surgeon, or other member of operating room staff, can use the display to note the current strain to which the body part 122 is subject.
The output data 110 comprising the data 138 representing that strain measurement can comprise at least one, or more than one, of the following taken jointly and severally in any and all permutations: a numerical indication representing the measure of strain, a graphical representation of the strain measurement, a colour indicative of the strain, a contour plot (with or without labels indicative of strain) showing the distribution or variation of the strain across the bodily part, or at least across a region of interest of the bodily part. Examples can be realized in which the region of interest is defined by the region covered by the reference or indicium 126.
The display 136 and the displayed output data 110 containing the data 138 indicative of the strain measurement are all shown in dashed-line form to indicate that the foregoing may or may not form an integral part of the optical measurement system 102. Examples can be realized in which the display 136 forms an integral part of the optical measurement system 102. Alternatively, examples can be realized in which the output data is merely output for display or further processing by an entity that does not form an integral part of the optical measurement system 102.
Examples can be realized in which both the display 136 and the camera 118 form integral parts of the optical measurement system 102. In such an example, an image 106a-106d presently within the field of view (not shown) of the camera 118 can be displayed on the display 136. Examples can be realized in which the output data 110 can be displayed independently of any image of the images 106a-d, or in conjunction with any such image of the images 106a-d. Examples can be realized in which the output data 110 is displayed in an overlaid or overlapping relationship with an image of the subject 122 and reference or indicium 126. Such an integrated optical measurement system comprising at least one, or both, of: the camera 118 and display 136, can be realized as, or as part of, a handheld device.
The camera 118 can further comprise a range finder 140. The range finder 140 determines the distance of the camera to the body part 122. The purpose of knowing the distance is so that changes in the image, in particular, in the reference or indicium 126, can be compensated for due to variations in proximity of the camera 118 to the subject. Alternatively, or additionally, the range finder 140 can be used to ensure that the images 106a-d are acquired at the same range from the subject. Still further, rather than using a range finder 140, a reference object can be placed within the field of view of the camera 118. The reference object has known physical characteristics. For example, the reference object can have known dimensions. The known dimensions can be used as a reference when determining the size of other objects within a captured image such as, for example, the dots described below.
The implant 124 is poised for seating. Therefore, the femur 122 will not be subject to any strain associated with the implant 124. Consequently, the image of the reference or indicium will not be changed or otherwise distorted due to the presence of strain within the femur 122. An image of such an unstrained body part can be an example of the above described reference image 128. However, a reference image does not have to be an image of an unstrained body part. Examples can be realized in which the reference image is captured merely temporally before the subsequent image 130.
It can be appreciated that the reference or indicium 126 has an increased width relative the reference or indicium depicted in
The implant 124 is in the process of being seated and is shown as being partially seated. Therefore, the femur 122 will be subject to strain associated with the implant 124. Consequently, the image of the reference or indicium will be changed or otherwise distorted due to the presence of strain within the femur 122. An image of such a strained body part can be an example of the above described subsequent image 130. It can be appreciated that the subsequent image has, firstly, been acquired at a later time relative to the reference image 128 and, secondly, has been acquired post a surgical event. In the example depicted, the surgical event will have been actuating the femoral prosthesis 124 to drive it into the current position.
As indicated above, the difference between the reference image 128 and the subsequent image 130 can be used to determine the strain to which the bone is subject due to the implant 124.
In the example depicted, the display 136 can display the indication 138 of the strain within body part 122. In the example shown in
It can be appreciated that the reference or indicium 126 has an increased width relative the reference or indicium depicted in
The implant 124 is shown as being more deeply or possibly fully being seated. Therefore, the femur 122 will be subject to strain associated with the implant 124. Consequently, the image 401 of the reference or indicium will be changed or otherwise distorted due to the presence of strain within the femur 122. An image of such a strained body part can be an example of the above described subsequent image 130. It can be appreciated that the subsequent image 401 has, firstly, been acquired at a later time relative to the reference image 128 and, secondly, has been acquired post a surgical event. In the example depicted, the surgical event will have been actuating the femoral prosthesis 124 to finally seat the implant 124.
As indicated above, the difference between the reference image and the subsequent image can be used to determine the strain to which the bone is subject due to the implant 124.
In the example depicted, the display 136 can display the indication 138 of the strain within body part 122. In the example shown in
It will be appreciated that the references or indicia are merely schematic for the purposes of explanation and illustration. As indicated above with reference to
Assume that the reference or indicium 126 is a single dot such as dot 202 and that the first image 201 is the reference image. The optical measurement system 102 is arranged to determine a respective diameter, do, of the dot 202.
Post actuating the implant 124 during the process of seating the implant 124, or having fully seated the implant 124, a temporally subsequent image such as, for example, image 301, is captured by the camera 118. Inserting or otherwise seating the implant 124 will cause the body part 122, which is the femur in the present example, to expand. That expansion will lead to a change in the reference or indicium 126. In the present case, the change in the indicium is shown as being a change in diameter. The optical measurement system 102 is arranged to determine a respective diameter, d1, of the dot 302, which is an expansion of the previous dot 202.
In general, strain is given by the ratio: a change in dimension/original dimension. Therefore, in the present case, the strain, ε1, experienced by the femur during the process of seating the implant 124 is given by:
Post further actuating the implant 124 until the implant 124 is more deeply or possibly fully seated, a further temporally subsequent image (not shown) can be captured by the camera 118. Again, having the implant 124 more deeply or possibly fully seated will cause the body part 122 to expand further. That further expansion will lead to a further change in the reference or indicium 126. In the present case, assume that the further change in the indicium is a continued expansion in diameter. The optical measurement system 102 would be arranged to determine a respective diameter, d2, of the newly expanded dot (not shown), which would be an expansion of the previous dot 302.
Therefore, at such a point in time, the strain, ε2, experienced by the femur when the implant 124 is more deeply or possibly fully seated would be given by:
Although the above examples of determining strain measurements rely on detecting a change in a physical characteristic of a reference, example are not limited to such arrangements. Examples can be realized in which a change in some other dimension can be used to determine the strain.
Although the above examples have been described with reference to using a subsequent image and a temporally immediately preceding image as the reference image, examples are not limited to such an arrangement. Examples can be realized in which any pair of temporally successive images are used as a reference image and a subsequent image. For example, the initial image 201 could be used as a reference image and the final image (not shown) could be used as the temporally subsequent image. In such an example, the strain, ε2, experienced by the femur when the implant 124 is more deeply or possibly fully seated would be given by:
Accordingly, examples can be realized in which a change in, for example, position or distance of, or associated with, the reference or indicium can be used as the basis for determining the strain.
Therefore, referring to
Therefore, the strain, ε2, is given by:
Although the examples described with reference to
Examples can be realized in which the camera 118 is a stereoscopic camera, or in which multiple cameras are used to capture the reference image and subsequent image. In such cases, 3D vectors can be used to determine strain, which will take into account any out of plane movement of the body part 122. Using such a stereoscopic camera or using multiple cameras supports realising examples without the above described range finder 140.
Alternatively, as described above with reference to
In the case of non-contact speckle pattern interferometry, it will be appreciated that the speckle pattern per se forms the reference or indicium 126. However, in other examples, the reference or indicium 126 can be applied to the body part 122 in advance of capturing any images or the body part 122 per se may bear features forming the reference or indicium 126. For example, the surface of the body part 122 may comprise a natural variation that can be used as a reference or indicium 122. For instance, the natural variability of a bone surface could serve as the reference or indicium 126. Alternatively, the surface of a body part could be intentionally patterned to bear such a reference or indicium 126. For instance, divots, scored marks, burn marks from a tool such as a bovie, and the like could be applied to the body part 122 to serve as a reference or indicium 126. Still further, a set of devices could be applied to the surface of the body part 122 to form the reference or indicium 126. The set of devices can comprise one or more than one device. A device of such a set can comprise an attachment to the body part such as, for example, a pin attached to the femur or other body part of interest. Still further, examples can be realized in which the reference or indicium 126 is applied to the body part 122 in the form of a mesh or paper bearing indicia. Such a paper or mesh may comprise, for instance, a speckle pattern or other random pattern. The paper or mesh may be affixed to the body part 122 using an adhesive such as, for example, a cyanoacrylate adhesive.
The reference or indicium 126 may be used in Digital Image Correlation to determine the strain within the body part 122.
A second output 704 presents on the display 301 a set of indicia 706 in which each indicium 708 to 714 forms a scale of different strain measurements extending from one indication of strain 708 to another indication of strain 714. The indications of strain 708 and 714 can represents a maximum strain 708 to a minimum strain 714 associated with the maximum and minimum strains measurable by the optical measurement system 102 or the maximum and minimum strains measured thus far by the optical measurement system 102. A current strain value 712 representing the latest strain measurement can be highlighted via a highlighting indicium 716 on the scale. Highlighting the current strain value 712 using the highlighting indicium 716 can take many different forms such as, for example, varying the intensity, colour, size, fill pattern, or some other graphical characteristic of the scale.
A third output 718 presents on the display 301 a set of indicia 720 in which each indicium 722 to 728 forms a scale of different strain measurements extending from one indication of strain 722 to another indication of strain 728. The indications of strain 722 and 728 can represents a maximum strain 722 to a minimum strain 728 associated with the maximum and minimum strains measurable by the optical measurement system 102 or the maximum and minimum strains measured thus far by the optical measurement system 102. A current strain value 726 representing the latest strain measurement can be highlighted via a highlighting indicium 730 on the scale. Highlighting the current strain value 726 using the highlighting indicium 730 can take many different forms such as, for example, varying the intensity, colour, size, fill pattern, or some other graphical characteristic of the scale. Examples can be realized in which one or more of the indicia 722 to 728 can have an adjacently displayed respective numerical strain measurement value 732 to 728. Alternatively, examples can be realized in which only the currently strain value 726 has a respective numeral strain measurement value 736 adjacently depicted.
The machine instructions 804 are instructions arranged, when processed by a processor 806, to implement the method of
Accordingly, the machine instructions 804 comprise:
Instructions 808 to capture a reference image 128 at a respective time, t1;
Instructions 810 to capture a temporally subsequent image 130 at a respective time, t2, following a surgical action, such as, for example, actuating the implant during the process of seating the implant 124;
Instructions 812 to determine the differences between the reference image 128 and the subsequent image 130;
Instructions 814 to derived a measure of strain from the established differences; and
Instructions 816 to output data 110 associated, with or representative of, the measure of strain for either display or further processing.
The reference image 128 and the temporally subsequent image 130 can be taken at respective points in time in response to an event, such as, for example, actuating or otherwise triggering the camera 118 to capture an image. Alternatively, the camera 118 can be arranged to generate a video stream comprising many temporally successive images. The reference image 128 and a temporally subsequent image 130 can be derived from the video stream to give a current measurement of strain. Alternatively, or additionally, a current indication of strain can be continuously displayed using respective pairs of reference and subsequent images of the video stream.
Referring to
The CASS 902 comprises a tracking system 906 that uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre. For example, a combination of infrared (IR) and visible light cameras can be used in an array. Such a tracking system 906 can use the EMR retro-reflected from any of the retro-reflectors described and/or claimed herein to determine real-time position data that locates at least one, or both, of the patient's anatomy and surgical instruments.
Accordingly, the CASS 902 shown in
The registration process that registers the CASS 902 to the relevant anatomy of the patient can also involve the use of anatomical landmarks, such as landmarks on a bone or cartilage. For example, the CASS 902 can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on the patient's actual bone using a probe that is connected to the CASS. Alternatively, the CASS 902 can construct a 3D model of the bone or joint without pre-operative image data by using location data of bony landmarks and the bone surface that are collected by the surgeon using a CASS probe or other means.
A tissue navigation system (not shown in
The CASS 902 comprises a display 908 to provide graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System as well other information relevant to the surgery to a surgeon or other operating theatre staff 928. The display 908 can be an example of the above described display 136. For example, the display 908 can overlay image information collected from various modalities (e.g., CT, MRI, 9-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions. A surgical computer 910 provides control instructions to various components of the CASS 902, collects data from those components, and provides general processing for various data needed during surgery. In the example depicted in
In some examples, the camera 118 may be integral with the tracking system 906. Example embodiments may incorporate the display 130 in whole or in part into the display 908. The optical measurement system 102 may be integral with the surgical computer 910. In such examples, the CASS 902 can be equipped to accomplish the methods and include the systems disclosed in
Examples can be realized according to the following clauses:
Clause 1: An intraoperative optical strain measurement system to determine strain within a target tissue to receive an implant; the system comprising: an input for receiving temporally consecutive images of the target issue; the temporally consecutive images comprising: at least one reference image and at least one subsequent image taken after the at least one reference image; a strain measurement processor comprising: measurement calculation circuitry, responsive to a data associated with a difference between the at least one reference image and the at least one subsequent image, to determine strain measurement data indicative of strain within the target tissue, and an output for outputting strain measurement data associated the measure of strain.
Clause 2: The system of clause 1, comprising a camera to generate the consecutive images of the target issue.
Clause 3: The system of clause 2, in which the camera is a stereoscopic camera.
Clause 4: The system of any preceding clause, in which the strain measurement processor is arranged to generate the strain measurement data by identifying differences between the at least one reference image and the at least one subsequent image.
Clause 5: The system any preceding clause, in which the strain measurement processor is arranged to generate at least one 2D vector (xs,ys)=(xsub−xref,ysub−yref) or at least one 3D vector (xs,ys,zs)=(xsub−xref,ysub−yref,zsub−zref) associated with movement of at least one indicium common to the at least one reference image and the at least one subsequent image.
Clause 6: The system of clause 5, in which the at least one indicium common to the at least one reference image and the at least one subsequent image comprises: at least two indicia common to the at least one reference image and the at least one subsequent image, optionally, in which the at least one indicium common to the at least one reference image and the at least one subsequent image comprises a speckle pattern.
Clause 7: The system of either of clauses 5 and 6, in which the strain measurement processor derives the strain measurement data of the target tissue from the at one 2D or 3D vector.
Clause 8: The system of any preceding clause, comprising at least one output device for displaying said strain measurement data.
Clause 9: The system of clause 8, in which the strain measurement data represents a 2D or 3D map of variation of strain across a respective region.
Clause 10: The system of clause 9, in which the 2D or 3D map is arranged to be displayed in an overlay registered relationship with an image of the target tissue material.
Clause 11: Machine-readable instructions arranged, when processed, to realize an intraoperative optical strain measurement system to determine strain within a target tissue; the instructions comprising: instructions for receiving temporally consecutive images of the target tissue; the temporally consecutive images comprising: at least one reference image bearing at least one reference indicium and at least one subsequent image, taken after the at least one reference image, bearing the at least one reference indicium; instructions to: generate strain measurement data, based on data associated with a difference the at least one reference image and the at least one subsequent image, indicative of strain of the target tissue, and instructions for outputting the strain measurement data.
Clause 12: Machine-readable instructions of clause 11, comprising instructions to control a camera to generate the consecutive images of the target tissue material.
Clause 13: Machine-readable instructions of either of clauses 11 to 12, comprising instructions to control at least one display device for displaying the strain measurement data.
Clause 14: Machine-readable instructions of clause 13, in which the strain measurement data represents at least one or more than one of the following taken jointly and severally in any and all permutations: an indicium indicative of the strain measurement data, a strain scale indicative of a range of strains, a numerical indication strain, a 2D or 3D map of variation of strain across a respective region of the target tissue material.
Clause 15: Machine-readable instructions of clause 14, in which the 2D or 3D map is arranged to be displayed in an overlaid registered relationship with an image of the target tissue material.
Clause 16: Machine-readable instructions of any of clauses 11 to 15, in which the instructions to generate strain measurement data is arranged to generate the strain measurement data by identifying differences between the at least one reference image and the at least one subsequent image.
Clause 17: Machine-readable instructions any of clauses 11 to 16, in which the instructions to generate the strain measurement data is arranged to generate at least one 2D vector (xs,ys)=(xsub−xref,ysub−yref) or at least one 3D vector (xs,ys,zs)=(xsub−xref,ysub−yref,zsub−zref) associated with movement of the at least one reference indicium common to the at least one reference image and the at least one subsequent image.
Clause 18: Machine-readable instructions of any of clauses 11 to 17, in which the at least one indicium common to the at least one reference image and the at least one subsequent image comprises: at least two indicia common to the at least one reference image and the at least one subsequent image; optionally, in which the at least one indicium common to the at least one reference image and the at least one subsequent image comprises a speckle pattern.
Clause 19: Machine-readable instructions of either of clauses 17 and 18, in which the instructions to generate the strain measurement data derives a measure of strain of the target material from the at one 2D or 3D vector.
Clause 20: Machine-readable storage storing machine-readable instructions of any of clauses 11 to 19.
Clause 21: An intraoperative method of determining a physical characteristic within a body member; the method comprising: creating at least two reference indicia on the body member in a predetermined region of interest of the body member; the at least two reference indicia being spaced-apart by a respective distance; capturing a reference image comprising the at least two reference indicia; performing a surgical action as part of a surgical procedure that subjects the body member to strain in the region of interest of the body member; capturing a further image comprising the at least two reference indicia; and deriving a measure of strain within the body member from the reference image and the further image.
Clause 22: The method of clause 21, in which deriving a measure of strain within the body member from the reference image and the further image comprises comparing the change in separation of the at least two reference indica between the reference image and the further image, and calculating a measure of strain from the change in separation of the at least two reference indicia and the respective distance.
Clause 23: An intraoperative optical measurement system to measure a strain to avoid a periprosthetic fracture within a bone to receive an implant; the system comprising: an input for receiving temporally consecutive images of the bone; the temporally consecutive images comprising: at least one reference image bearing at least one reference indicium; and at least one subsequent image, taken after the at least one reference image and post a surgical action associated with the implant, bearing the at least one reference indicium; a strain measurement processor arranged to: determine strain measurement data associated with strain of the bone from data associated with a difference between the at least one reference image and the at least one subsequent image; and an output for outputting strain measurement data.
Clause 24: An intraoperative method of determining a measure of strain within a body member; the method comprising: illuminating the body member in a region of interest of the body member with an object beam speckle pattern derived from a laser; capturing a reference image comprising a combination of the object bean speckle pattern reflected from the region of interest of the body member with a reference beam speckle pattern derived from the laser; performing a surgical action as part of a surgical procedure that subjects the body member to strain in the region of interest of the body member; capturing a temporally subsequent image comprising a further combination of the object bean speckle pattern reflected from the region of interest of the body member with a respective reference beam speckle pattern derived from the laser; and deriving a measure of strain within the body member from the reference image and the temporally subsequent image.
Clause 25: The intraoperative method of clause 24, in which deriving a measure of strain within the body member from the reference image and the temporally subsequent image comprises: generating a phase displacement map, and determining a measure of strain from the phase displacement map.
This application claims the benefit of U.S. Provisional Application No. 63/622,142, filed on Jan. 18, 2024. The entire disclosure of the application referenced above is incorporated herein by reference. The present application relates to optical measurement systems and methods. Periprosthetic fractures may occur for many reasons, including when implants are seated with too great a force or are subjected to high loading in vivo. Alternatively, such fractures can also arise in cases of compromised bone quality. In general, implants fit into bone with some degree of mechanical interference, which is particularly true in Total Hip Arthoplasty (THA) where, following the study in Pagani N R, Varady N H, Chen A F, Rajaee S S, Kavolus J J. Nationwide Analysis of Lower Extremity Periprosthetic Fractures. J Arthroplasty. 2021 January; 36(1):317-324, doi: 10.1016/j.arth.2020.07.050. Epub 2020 Jul. 25. PMID: 32826143, roughly 2% of implant recipients experience a fracture at some point post-operatively.
Number | Date | Country | |
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63622142 | Jan 2024 | US |