Attachment for elastography and / or imaging devices

Abstract

The present disclosure provides an attachment for an elastography and / or imaging device. The device has a transparent portion for transmission of electromagnetic radiation or sound waves towards a sample material. The attachment includes a fixing portion for fixing the attachment to the device. The attachment further includes a sensing portion coupled to the fixing portion. The sensing portion is adapted to receive a deformable sensing layer that is at least partially transparent to electromagnetic radiation or sound waves. The attachment is attached to the device and is arranged such that when the sensing layer is received in the sensing portion, electromagnetic radiation is transmitted through the sensing layer in use or sound waves are transmitted through the sensing layer towards the sample material, and the sensing layer is arranged to deform when a load is applied through the sensing layer to the sample material.

Description

[Technical field]

[0001] The present invention relates to attachments for elastography and / or imaging devices, and more particularly, but not exclusively, to removable attachments for optical elastography devices. [Background technology]

[0002] Elastography techniques based on optical imaging, ultrasound imaging, and magnetic resonance imaging (MRI) are commonly used to characterize the deformation of sample materials, such as biological tissues, as well as to assess the stiffness and other mechanical properties of the samples.

[0003] In recent years, there have been developments in elastography techniques, such as optical coherence tomography (OCT)-based elastography. The applicant has developed an optical elastography technique that uses a compliant sensing layer that is compressed against the surface of a sample material. This technique is disclosed in PCT International Patent Application No. PCT / AU2016 / 000019, which is incorporated herein by cross-reference. The applicant has further developed an optical elastography device that is digital camera-based and can be handheld. This device and method for evaluating mechanical properties, such as elasticity, of a sample material using an optical elastography device is disclosed in PCT International Patent Application No. PCT / AU2019 / 051171, which is also incorporated herein by cross-reference. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2016 / 119011 [Patent Document 2] International Publication No. 2020 / 082133 Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention provides a further improvement. [Means for solving the problem]

[0006] According to a first aspect of the invention there is provided an attachment for an elastography and / or imaging device, the device having a transparent part for the transmission of electromagnetic radiation or sound waves towards a sample material, the attachment comprising: A fixing part for fixing the attachment to the device; a sensing portion coupled to the fixed portion, the sensing portion adapted to receive a deformable sensing layer that is at least partially transparent to electromagnetic radiation or acoustic waves; Including, An attachment is provided which is attached to the device and arranged such that when the sensing layer is received in the sensing portion, electromagnetic radiation is transmitted through the sensing layer, or acoustic waves are transmitted through the sensing layer towards the sample material, during use, and the attachment is arranged such that when a load is applied through the sensing layer to the sample material, the sensing layer is deformed.

[0007] The attachment can be attached to the device and arranged such that when the sensing layer is received in the sensing portion, electromagnetic radiation is transmitted through the sensing layer during use or acoustic waves are transmitted through the sensing layer towards the sample material, and arranged such that when a load is applied through the sensing layer to the sample material, the sensing layer can expand laterally to the longitudinal axis of the device.

[0008] The sensing layer, in one particular embodiment, comprises a material having a mostly incompressible volume, although in alternative embodiments, the sensing layer may comprise a material that is at least partially compressible.

[0009] The device may include a probe, and the attachment may be arranged for attachment to the probe.

[0010] The attachment can include a sensing layer, and the sensing layer can be positioned in the sensing portion.

[0011] The sensing layer can be positioned in the sensing portion using straps or layers of material, which can be flexible. The sensing layer can be sandwiched between the layers or straps.

[0012] The attachment may further include a lubricating material in the sensing layer to reduce friction between the sensing layer and a strap or layer of flexible or another material that the sensing layer may contact during use.

[0013] The attachment may include a cavity, and when an axial load is applied through the sensing layer to the sample material, the sensing layer may expand laterally into the cavity, or the lubricating material may penetrate into the cavity.

[0014] Further, the attachment can include an end portion at the sensing portion, the end portion including a wavy edge having inwardly projecting protrusions separated by recesses, the end portion positioned such that when an axial load is applied through the sensing layer to the sample material, a portion of the sensing layer can expand laterally into or through the recesses between the protrusions and / or such that the lubricating material can infiltrate.

[0015] The cross-sectional shape of the attachment may be approximately U-shaped when the sensing layer is received by the attachment.

[0016] The attachment may have a generally cylindrical shape.

[0017] The fixed portion can have at least one side portion positioned to engage with a side portion of the device, and the sensing portion of the attachment can be a bottom portion coupled to the at least one side portion.

[0018] The attachment can be adapted to removably attach to the device.

[0019] At least one side portion of the attachment is arranged to engage with a side portion of the device using a twist lock or luer lock mechanism in one embodiment. In this embodiment, the side portion of the attachment can be provided with a keyway or key and the device can be provided with a complementary key or keyway. Alternatively, the side portion of the attachment can be provided with an at least partially threaded bore and the side portion of the device can be provided with a complementary external thread.

[0020] Alternatively, at least one side portion can include a male locking portion that is arranged to interlock with a female locking portion of a side portion of the device.

[0021] At least one side portion of the attachment, in this embodiment, is arranged to engage with a side portion of the device using a snap fit.

[0022] The attachment may further include a protective sheath arranged to cover at least a portion of the exposed area of ​​the attachment, the protective sheath may be clamped between elements of the fixed part or between the fixed part and an element of the device when the attachment is attached to the device, and the protective sheath may extend along at least a portion of the exposed area of ​​the device when the attachment is attached to the device.

[0023] In an alternative embodiment, the protective sheath is a first protective sheath, which is arranged to cover at least a portion of the exposed area of ​​the attachment and can be clamped between the elements of the fixed part or between the fixed part and the element of the device when the attachment is attached to the device. The attachment further comprises in this embodiment a second protective sheath, which is arranged to cover at least a portion of the exposed area of ​​the device when the attachment is attached to the device. Also, the second protective sheath can be clamped between the elements of the fixed part or between the fixed part and the element of the device when the attachment is attached to the device.

[0024] At least the outer surface portion, and typically the inner surface portion, of the attachment can be formed from a biocompatible material.

[0025] The device is, in one embodiment, an optical elastography device, in which the attachment can include an optical imaging window in the sensing portion, and the optical elastography device with the attachment can be positioned to direct electromagnetic radiation from the optical elastography device through the imaging window, and then through the sensing layer, when the sensing layer is received in the sensing portion, towards the sample material.

[0026] The optical elastography device can be an optical coherence tomography-based elastography device.

[0027] The sensing layer can have a predetermined deformation-dependent optical property, which can be detectable using optical means, for example using a digital or stereoscopic camera setup, as disclosed in applicant's co-pending PCT International Application No. PCT / AU2019 / 051171, which is incorporated herein by cross-reference. In one example, the sensing layer includes particles and can have a deformation-dependent transmittance, as also disclosed in applicant's co-pending PCT International Application No. PCT / AU2019 / 051171.

[0028] In alternative embodiments, the elastography device is an ultrasound-based or MRI-based elastography device.

[0029] The elastography device can be handheld and the attachment can be disposable.

[0030] The sensing layer may include a silicone material.

[0031] According to a second aspect of the present invention there is provided an elastography and / or imaging system comprising: an elastography and / or imaging device having a transparent portion for the transmission of electromagnetic radiation or acoustic waves towards the sample material; An attachment fixable to a device, the attachment being provided according to a first aspect of the present invention; a deformable sensing layer coupled to the attachment at a sensing portion; Including, An elastography and / or imaging system is provided in which, when the device is in use, electromagnetic radiation is transmitted through the sensing layer or acoustic waves are transmitted through the sensing layer towards the sample material, and the sensing layer is arranged to deform when a load is applied through the sensing layer to the sample material.

[0032] The system can be arranged so that electromagnetic radiation is transmitted through the sensing layer, or acoustic waves are transmitted through the sensing layer towards the sample material, and can be arranged so that when a load is applied through the sensing layer to the sample material, the sensing layer expands transversely to the longitudinal axis of the device.

[0033] The sensing layer, in one particular embodiment, comprises a material having a mostly incompressible volume, although in alternative embodiments, the sensing layer may comprise a material that is at least partially compressible.

[0034] The device may include a probe, which may have an end portion for transmission of electromagnetic radiation or sound waves toward a sample material.

[0035] The sensing surface of the sensing layer can be adapted for positioning in direct or indirect contact with a surface area of ​​the sample material.

[0036] The system may in one embodiment be an optical device, and the sensing layer may have predetermined deformation-dependent optical properties. The optical system may in this embodiment be arranged such that in response to electromagnetic radiation or sound waves transmitted through the sensing layer towards the sample material, the mechanical properties of the sample material may be measured by detecting electromagnetic radiation or sound waves transmitted from the sample material through the sensing layer.

[0037] The system can be an elastography system and the device can be an elastography device having a transparent portion for transmission of electromagnetic radiation or sound waves toward the sample material. The elastography device can be an optical elastography device.

[0038] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: FIG. [Brief description of the drawings]

[0039] [Figure 1(a)] FIG. 2 is a schematic perspective view of an attachment for an elastography and / or imaging device, according to an embodiment, with the attachment secured to an end portion of a probe of the device. [Figure 1(b)] FIG. 2 is a schematic perspective view of the attachment of FIG. [Diagram 2] FIG. 2 is a schematic perspective view of an attachment for an elastography device according to another embodiment, the attachment being secured to a probe of the device. [Diagram 3] FIG. 3 is a perspective view of the attachment of FIG. 2 when not attached to a probe of a device. [Figure 4] FIG. 4 is a photograph of the attachment of FIG. 2 and FIG. 3. [Diagram 5] FIG. 1 is a schematic diagram of an optical elastography device according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] Ultrasound elastography, MRI-based elastography, and optical coherence elastography techniques can be used to map the mechanical properties, such as stiffness (elasticity), of biological tissues, which can be affected by diseases such as cancer, and one application of these techniques is for the identification of cancerous tissue, which is typically "stiffer" than the surrounding soft tissue.

[0041] The applicant has previously developed an optical elastography technique in which a compressive load is applied to the sample material through a deformable sensing layer positioned between the probe and the sample material. The sensing layer comprises a transparent silicone material, which is incompressible and therefore deforms under the application of a compressive load by expanding in a plane transverse to the applied load to conserve its volume. Thus, the thickness of the sensing layer changes in response to the local stiffness of the underlying sample material, and using, for example, optical coherence tomography (OCT), the change in the thickness of the sensing layer induced by the compressive load can be measured to provide a measure for the local stress of the underlying sample material. Using OCT, the strain in the sample can also be determined, which, together with the determined stress in the sample, can provide the stiffness of the sample.

[0042] An embodiment of the present invention provides an attachment for an elastography and / or imaging device that is arranged such that a deformable sensing layer having an incompressible volume may be used without compromising the change in thickness of the sensing layer (e.g., by impeding the lateral expansion of the layer) as a function of the change in "stiffness" of the underlying sample material.

[0043] In certain embodiments, the attachment is disposable and adapted to be removably secured to an elastography and / or imaging device.

[0044] A particular embodiment of the attachment will be described with reference to Figures 1 and 2. In this embodiment, the attachment is suitable for an optical elastography device and is adapted to be secured to an optical probe of the device. However, it will be understood that embodiments of the invention are not limited to use in optical elastography. For example, the device could alternatively be an ultrasound device or an MRI device, and may or may not be an imaging device.

[0045] FIG. 1(a) is a perspective view of an attachment 100 fixed to an optical probe 102 of an optical elastography device, and FIG. 1(b) shows the attachment 100 in isolation. The attachment 100 includes a fixed portion 104 for fixing the attachment 100 onto the optical probe 102. The optical probe 102 has a transparent portion (also not shown) for transmitting electromagnetic radiation towards a sample material (not shown). The attachment 100 further includes a ring-shaped portion 106 coupled to the fixed portion 104 and adapted to receive a deformable sensing layer 108, the sensing layer 108 being at least partially transparent to electromagnetic radiation. The attachment 100 is attached to the probe 102 (as shown in Figures 1(a) and 1(b)) and is arranged such that, when the sensing layer 108 is received, electromagnetic radiation is transmitted through the sensing layer 108 towards a sample material, and such that, when an axial load is applied through the sensing layer 108, the sensing layer 108 can expand transversely to the longitudinal axis of the probe 102.

[0046] One skilled in the art will recognize that in alternative embodiments where the device is an ultrasonic device, the probe will have a transparent portion for the transmission of acoustic or ultrasonic waves and the attachment will be adapted to receive a sensing layer that is at least partially transparent to acoustic or ultrasonic waves.

[0047] The attachment 100 with the sensing layer 108 has a U-shaped cross-sectional configuration and is generally cylindrical, with the components of the attachment 100 formed from a flexible polymeric material. As will now be described in more detail, the ring-shaped portion 106 is coupled to the fixed portion 104 using annular compression, in this example. The inner surface of the ring-shaped portion 106 has a protrusion 112 and the outer surface of the fixed portion 104 has a corresponding recess 116 that is arranged to engage the protrusion 112.

[0048] In this embodiment, the attachment 100 includes a sensing layer 108 that is coupled to the ring-shaped portion 106 using layers 118, 120. The sensing layer 108 is sandwiched between layers 118, 120, which hold the sensing layer 108 in the ring-shaped portion 106 and are formed from a flexible material. The attachment 100 is mounted to the probe 102 and positioned such that a sensing surface 121 of the sensing layer 108 is in indirect contact with a sample material (not shown) when the sensing layer 108 is received and coupled to the ring-shaped portion 106.

[0049] The layers 118, 120 are fixed between the ring-shaped portion 106 and the fixed portion 104, and the outer dimensions of the sensing layer 108 are selected to define a cavity 109 between the outer portions of the layers 118, 120 at the edge portions of the sensing layer 108. The sensing layer 108 is positioned by the layers 118, 120 to allow lateral expansion of the sensing layer 108 into the cavity 109 relative to the longitudinal axis of the probe 102 when an axial load is applied through the sensing layer 108.

[0050] Also, a lubricating material is provided between the layers 118, 120 and the sensing layer 108. The lubricating material is selected to reduce friction between the sensing layer 108 and the layers 118, 120. The attachment 100 is arranged such that the lubricating material is allowed to flow into the cavity 109 when an axial load is applied through the sensing layer 108 (the material of the sensing layer 108 can also expand laterally into the cavity 109). The lubricating material can be any suitable material that reduces friction between the sensing layer 108 and the layers 118, 120, for example, silicone oil, vegetable oil, or synthetic liquids, such as hydrogenated polyolefins, esters, or fluorocarbons. By reducing the friction between the sensing layer 108 and the layers 118, 120, thickness changes correspond more accurately to changes in the "stiffness" of the underlying sample material. As a result, the resolution of optical elastography techniques can be improved.

[0051] The ring-shaped portion 106 also has end portions with wavy edges formed by inwardly projecting protrusions 113 and recesses 115. The end portions are arranged such that when an axial load is applied to the sample material through the sensing layer 108, a portion of the sensing layer 108 and / or lubricating material can penetrate into or through the recesses 115 between the protrusions 113. The protrusions 113 and further portions of the attachment 100 may also include a radiopaque material or coating.

[0052] The fixed portion 104 has a side portion 130 that is arranged to engage with a side portion 132 of the probe 102 using a twist lock or luer lock mechanism. An inner surface of the side portion 130 includes a protrusion 136 and an outer surface portion of the probe 102 has a recess 134. Furthermore, the probe 102 has a keyway (not shown) along which the protrusion (or "key") 136 of the side portion 130 can be guided in a direction along the axis of the attachment 100. A twisting movement of the attachment 100 relative to the probe 102 then engages the protrusion 136 with the recess 134, securing the attachment 100 onto the probe 102.

[0053] The probe 102 includes an imaging window 148. In a variation of the described embodiment, the imaging window may form part of the attachment 100 or may be positioned in the layer 120. An adhesive material may be used to hold the imaging window in the layer 118. Electromagnetic radiation is directed from the probe 102 through the imaging window 148 and then through the sensing layer 108.

[0054] 2, 3 and 4 illustrate an attachment 200 according to another embodiment of the invention. The attachment 200 is adapted to be fixed to an optical probe 202. The attachment 200 includes a fixing portion 204 for fixing the attachment 200 to a probe 202 of a device, such as an optical elastography device. The probe 202 is an optical probe in this embodiment and has a transparent portion (not shown) for the transmission of electromagnetic radiation towards a sample material (not shown). The attachment 200 further includes a ring-shaped portion 206, which is coupled to the fixing portion 204 by an arrangement similar to that described with reference to Figs. 1(a) and 1(b). The ring-shaped portion 206 is adapted to receive a sensing layer 208, which is at least partially transparent to electromagnetic radiation. The attachment 200 is attached to the optical probe 202 (as shown in FIG. 2 ) and is arranged such that when the sensing layer 208 is received in the ring-shaped portion 206, electromagnetic radiation is transmitted through the sensing layer 208 to a sample material, and such that when an axial load is applied through the sensing layer 208, the sensing layer 208 can expand transversely to the longitudinal axis of the probe 202.

[0055] The attachment 200 includes a sensing layer 208 that is coupled to a ring-shaped portion 206 using layers 218, 220 of flexible material as described with respect to the attachment 100 above with reference to Figures 1(a) and 1(b). The attachment 200 has a U-shaped cross-sectional shape and is generally cylindrical. The ring-shaped portion 206 is coupled to the fixed portion 204 using a snap-fit ​​mechanism. The sensing layer 208 is sandwiched between layers 218, 220, which hold the sensing layer 208 in the ring-shaped portion 206. The sensing layer 208 has dimensions selected to allow lateral expansion of the sensing layer 208 between layers 218, 220. The layers 218, 220 are fixed between a surface of the ring-shaped portion 206 and a surface of the fixed portion 204 in such a manner that a cavity 226 is defined between the layers 218, 220. A lubricating material is provided on the periphery of the sensing layer 208. The lubricating material is arranged to reduce friction between the sensing layer 208 and the layers 218, 220. With respect to the attachment 100, the lubricating material can be any suitable material that reduces friction between the sensing layer 208 and the layers 218, 220, and can be, for example, a silicone oil, a vegetable oil, or a synthetic liquid, such as a hydrogenated polyolefin, an ester, or a fluorocarbon.

[0056] The fixed portion 204, in this embodiment, has five side portions or prongs 230 that are arranged to engage side portions 232 of the probe 202 with a frictional fit. The attachment 200 is appropriately sized to be fixed to the probe 202, and each side portion 230 has a size and shape such that each side portion 230 can maintain firm contact with the probe 202 when the attachment 200 is positioned over the probe 202.

[0057] The attachment 200 is thus arranged such that, when attached to the probe 202 (as shown in FIG. 2), the sensing surface 236 of the sensing layer 208 is adapted for positioning in indirect contact with a surface area of ​​the sample material.

[0058] In one embodiment, the attachment 200 includes an imaging window 242 in layer 220 such that when the attachment 200 is attached to an end portion of the probe 202, the imaging window 242 is positioned between the end of the probe 202 and the sensing layer 208. This arrangement is such that electromagnetic radiation is directed from the probe 202 through the imaging window 242 and then through the sensing layer 208 to the sample material. In the embodiment shown in Figures 2-4, a window mount 244 is further provided to accommodate the imaging window 242 into the shape of the probe 202.

[0059] The attachment 100, 200 according to any one of the described embodiments includes a protective sheath (not shown) attached to the fixed portion 104, 204 or the ring-shaped portion 106, 206 in any suitable manner such that the protective sheath extends along the fixed portion 104, 204 of the attachment 100, 200 and is clamped between elements of the fixed portion 104, 204 when the attachment 100, 200 is secured to the probe 102, 202. For example, an end portion of the protective sheath can be secured between an inner surface of the ring-shaped portion 106, 206 and an outer surface of the fixed portion 104, 204. The protective sheath can also extend along a portion of the exposed area of ​​the device when the attachment 100, 200 is attached to the device. Alternatively, the attachment 100, 200 can include an additional sheath (not shown) that is also clamped between elements of the fixed portions 104, 204 but extends to cover exposed areas of the device when the attachment 100 is attached to the device.

[0060] When the attachment 100, 200 is secured to the probe 102, 202 and the optical elastography device is in use, the sensing surface 121, 236 of the sensing layer 108, 208 is positioned in indirect contact with a surface area of ​​the sample material (not shown) through the layer 118, 218. The layers 118, 120, 218, 220 help prevent contamination of the sample material and the probe and help ensure sterile conditions during use.

[0061] The sample material may be a biological tissue or material, or alternatively, may include another elastic body or material, such as a polymeric material, which may have non-uniform hardness or flexibility.

[0062] The sensing layer 108, 208 may include a silicone material or another suitable material.

[0063] It will be understood that other materials that are transparent and at least partially transparent to electromagnetic radiation are also contemplated for the sensing layer.Furthermore, embodiments are contemplated in which the attachment is secured to a probe of the device and in which the sensing layer is received in such a manner that, when the device is in use, a sensing surface of the sensing layer is positioned in direct contact with a surface area of ​​a sample material.

[0064] In an alternative embodiment, the attachment uses a deformable sensing layer with deformation-dependent optical properties. In this embodiment, the change in thickness of the sensing layer upon application of a compressive load may not need to be detected, but the change in optical properties (such as a change in color or transmittance of the layer; the change in optical properties can be detected using stereoscopic or UV fluorescence techniques, for example, as disclosed in applicant's co-pending PCT International Application No. PCT / AU2019 / 051171) is a measure of the change in thickness (and stiffness of the underlying sample material).

[0065] Furthermore, in embodiments in which the probe is an acoustic probe, the sensing layer comprises a deformable material that is at least partially transparent to acoustic waves.

[0066] All parts of the attachments 100, 200 are formed from a biocompatible material in this embodiment. Alternatively, it is envisioned that at least an outer surface portion of the attachments 100, 200 is formed from a biocompatible material. Additionally, in one embodiment, all parts of the attachments 100, 200 are disposable.

[0067] It will be understood that other embodiments of the attachment are envisioned, in which the sensing portion can be coupled to the fixed portion in any other suitable manner, and the sensing layer can be received in the sensing portion in any other suitable manner.

[0068] The attachments 100, 200, in this embodiment, are attached to the optical probe of a handheld optical elastography device for assessing mechanical properties of sample materials, such as that disclosed in applicant's PCT International Patent Application No. PCT / AU2019 / 051171. However, those skilled in the art will appreciate that attachments according to embodiments of the invention may also be attached to the optical probe of a handheld optical imaging device that does not have elastography capabilities, and / or to the probe of an ultrasound device or an MRI device.

[0069] One embodiment of the invention uses an elastography system that includes an elastography device, such as those described above, an attachment, such as attachment 100 or 200, attached to the elastography device, and a deformable sensing layer coupled to the attachment at a ring-shaped portion 106, 206. Figure 5 illustrates an optical elastography system 500 that includes a handheld optical elastography device 502 provided in the shape of a pen. The handheld optical elastography device 502 includes an elongated handheld optical probe 503 having a transparent portion 504 at an end thereof for transmitting electromagnetic radiation toward a sample material 512, and an attachment 506 that is fixed to the end portion 504 of the elongated optical probe 503 of the elastography device 502, similar to any one of the attachments 100, 200 shown in schematic form. The optical elastography system 500 thus also includes a sensing layer 508 coupled to the attachment 506. The handheld optical elastography device 502 is positioned with a sensing surface 509 of the sensing layer 508 in indirect contact (through a flexible layer such as layer 118 or 218) with a surface area 510 of a sample material 512, such as biological tissue. In this embodiment, the sensing layer 508 comprises a material having predetermined deformation-dependent optical properties and changes color or transmittance upon application of an axial load. The handheld probe 503 is camera-based and equipped with a photodetector 514 positioned such that light transmitted through the sensing layer 508 from the sample area 510 of the sample material 512 can be detected in response to emitting and transmitting light through the sensing layer 508 towards the surface area 510. In this regard, it is envisioned that a light source (not shown) is provided in the optical probe 503 to direct light through the sensing layer 508.In the illustrated embodiment, the optical probe 503 includes a photodetector 514, which is provided in the form of a camera, such as a digital charge-coupled device (CCD) camera. The optical elastography system 500 is arranged such that electromagnetic radiation is transmitted through the sensing layer 508 towards the sample material 512, and such that when an axial load is applied through the sensing layer 508, the sensing layer 508 can expand transversely to the longitudinal axis of the optical probe 503 and the elastography device 502. Due to certain deformation-dependent optical properties of the sensing layer 508, the deformation of the sensing layer 508 affects the light in the sensing layer 508, such that the light detected by the camera 514 is a measure of the change in the optical properties of the sensing layer, and consequently, the mechanical properties of the sample material 512 at the surface area 510. In a variation of the described embodiment, the camera 514 can be replaced by a suitable stereoscopic setup such as that disclosed in the applicant's co-pending PCT International Application No. PCT / AU2019 / 051171.

[0070] The camera-based optical elastography device 500 is wirelessly coupled, such as using Wi-Fi or Bluetooth, to a microprocessor 516 in communication with a graphical interface 518, thereby forming a system 520 for evaluating mechanical properties of a sample material 512. The microprocessor 516 can be provided in the form of a computer, such as a desktop computer, or can be provided in the form of a mobile device, such as a tablet or mobile phone. The microprocessor 516 is configured to receive an electrical signal from the optical elastography device 500. The signal indicates information associated with the light detected by the CCD camera 514. The information can then be used by the microprocessor 516 and the graphical interface 518 and converted into an image. The image indicates the distribution of stress and deformation across the sensing layer 508.

[0071] In another embodiment, the attachment is adapted to attach to an optical probe of an OCT elastography device. In this embodiment, the sensing layer does not have deformation-dependent optical properties but is transparent to electromagnetic radiation, and the OCT elastography device uses OCT to scan the depth of the sensing layer and obtain a depth profile of the sensing layer that is represented in the OCT image. The information obtained using OCT can then be used to characterize the mechanical properties of the sample material, such as the elasticity of the sample material.

[0072] In another embodiment again, the attachment is adapted to attach to an optical probe of an optical elastography device, which can be handheld and, unlike OCT, does not require scanning the entire thickness of the sensing layer to obtain information about the mechanical properties of the sample material. In this embodiment, the sensing layer is also transparent to electromagnetic radiation, and the mechanical properties of the sample material can be derived based on knowledge of the initial thickness of the sensing layer (before the axial load is applied) and based on the change in the thickness of the layer as detected from the interface of the signals reflected at the bottom and top interfaces of the layer when the axial load is applied. The detected interference signal provides information about the change in the relative position of the interface between the sensing layer and the sample material, and consequently, about the change in the thickness of the layer.

[0073] In another embodiment, the elastography device may be an MRI-based elastography device rather than an optical elastography device, or may be an acoustic elastography device, such as an ultrasound elastography device, that includes a probe having a transparent portion for the transmission of sound waves.

[0074] Modifications and variations as would be apparent to one skilled in the art are determined to be within the scope of the present invention. For example, one skilled in the art will recognize that in a variation of the described embodiment, the sensing layer 108, 208, or 508 can include a compressible material, such as a sponge-like material or another material that can have air pockets and has a compressible volume. [Explanation of symbols]

[0075] 100 Attachments 102 Optical Probe 104 Fixed part 106 Ring-shaped part 108 Sensing Layer 109 Cavity 112 Protrusion 113 Protrusion 115 Recess 116 Recess 118 layers 120 layers 121 Sensing Surface 130 Side part 132 Side part 134 Recess 136 Protrusion 148 Imaging Window 200 Attachments 202 Probe 204 Fixed part 206 Ring-shaped part 208 Sensing Layer 218 layers 220 layers 226 Cavity 230 Side section, prongs 232 Side part 236 Sensing Surface 242 Imaging Window 244 Window mounting part 500 Optical Elastography System 502 Optical Elastography Device 503 Optical Probe 504 Transparent part, edge part 506 Attachment 508 Sensing Layer 509 Sensing Surface 510 Surface Area, Sample Area 512 Sample Material 516 Microprocessor 518 Graphical Interface

Claims

1. 1. An attachment for an elastography and / or imaging device, said device having a transparent portion for transmission of electromagnetic radiation or sound waves towards a sample material, said attachment comprising: a fixing portion for fixing the attachment to the device; a sensing portion coupled to the fixed portion, the sensing portion adapted to receive a deformable sensing layer that is at least partially transparent to the electromagnetic radiation or the acoustic waves; Including, The attachment is attached to the device and is arranged so that when the sensing layer is received in the sensing portion, the electromagnetic radiation is transmitted through the sensing layer during use or the acoustic waves are transmitted through the sensing layer towards the sample material, and the attachment is arranged so that the sensing layer deforms when a load is applied to the sample material through the sensing layer.

2. 2. The attachment of claim 1, wherein the attachment is attached to the device and arranged such that when the sensing layer is received in the sensing portion, the electromagnetic radiation is transmitted through the sensing layer during use or the acoustic waves are transmitted through the sensing layer towards the sample material, and the attachment is arranged such that when the load is applied to the sample material through the sensing layer, the sensing layer expands laterally relative to a longitudinal axis of the device.

3. The attachment of claim 2 , wherein the sensing layer comprises a material having a mostly incompressible volume.

4. The attachment of claim 1 , wherein the device includes a probe, and the attachment is arranged for attachment to the probe.

5. The attachment of claim 1 including the sensing layer.

6. The attachment of claim 5 , wherein the sensing layer is positioned on the sensing portion using a strap or layer of flexible material.

7. 7. The attachment of claim 6, wherein the sensing layer is sandwiched between the layers or straps of flexible material.

8. 10. The attachment of claim 1, further comprising a lubricating material in the sensing layer to reduce friction between the sensing layer and components of the device that the sensing layer contacts during use.

9. 2. The attachment of claim 1, wherein the attachment includes a cavity, and when the load is applied to the sample material through the sensing layer, the layer is capable of expanding laterally into the cavity.

10. 2. The attachment of claim 1, wherein the attachment includes a cavity, and the lubricating material is capable of penetrating into the cavity when the load is applied to the sample material through the sensing layer.

11. 2. The attachment of claim 1, wherein the attachment includes an end portion at the sensing portion, the end portion including a wavy edge having inwardly projecting protrusions separated by recesses, the end portion being positioned such that when an axial load is applied to the sample material through the sensing layer, a portion of the sensing layer can expand laterally between the protrusions into or through the recesses.

12. 9. The attachment of claim 8, wherein the attachment includes an end portion at the sensing portion, the end portion including a wavy edge having inwardly projecting protrusions separated by recesses, the end portion being positioned such that the lubricating material can penetrate into or through the recesses between the protrusions when an axial load is applied to the sample material through the sensing layer.

13. The attachment of claim 1 , wherein the cross-sectional shape of the attachment is approximately U-shaped when the sensing layer is received by the attachment.

14. 10. The attachment of claim 1, wherein the attachment has a generally cylindrical shape.

15. 2. The attachment of claim 1, wherein the fixed portion has at least one side portion positioned to engage a side portion of the device, and the sensing portion of the attachment is a bottom portion connected to the at least one side portion.

16. 16. The attachment of claim 15, wherein the attachment is adapted to removably attach to the device.

17. 17. The attachment of claim 16, wherein the at least one side portion includes a locking portion arranged to interlock with a corresponding locking portion of the side portion of the device.

18. 18. The attachment of claim 17, wherein the at least one side portion of the attachment engages the side portion of the device using a snap fit.

19. 18. The attachment of claim 17, wherein the at least one side portion of the attachment engages with the side portion of the device using a twist lock or luer lock mechanism.

20. The attachment of claim 1 , further comprising a protective sheath positioned to cover at least a portion of the exposed area of ​​the attachment.

21. 21. The attachment of claim 20, wherein the protective sheath extends along at least a portion of an exposed area of ​​the device when the attachment is attached to the device.

22. 21. The attachment of claim 20, wherein the protective sheath is a first protective sheath arranged to cover at least a portion of an exposed area of ​​the attachment, and the attachment further includes a second protective sheath arranged to cover at least a portion of an exposed area of ​​the device when the attachment is attached to the device.

23. The attachment of claim 1 , wherein at least an outer surface portion of the attachment is formed from a biocompatible material.

24. The attachment of claim 1 , wherein the device is an elastography device.

25. 25. The attachment of claim 24, wherein the device is an optical elastography device.

26. 26. The attachment of claim 25, further comprising an optical imaging window in the sensing portion, wherein the optical elastography device with the attachment is arranged to direct the electromagnetic radiation from the elastography device through the imaging window and, when the sensing layer is received, thereafter through the sensing layer towards the sample material.

27. 26. The attachment of claim 25, wherein the optical elastography device is an optical coherence tomography elastography device.

28. 26. The attachment of claim 25, wherein the sensing layer has predetermined deformation-dependent optical properties.

29. The attachment of claim 1 , wherein the elastography device is an ultrasound device.

30. The attachment of claim 1 , wherein the elastography device is an MRI-based device.

31. The attachment of claim 1 , wherein the device is handheld.

32. The attachment of claim 1 , wherein the attachment is disposable.

33. The attachment of claim 1 , wherein the sensing layer comprises a silicone material.

34. 1. An elastography and / or imaging system comprising: an elastography and / or imaging device having a transparent portion for transmission of electromagnetic radiation or acoustic waves towards the sample material; an attachment fixable to the device, said attachment being provided according to any one of claims 1 to 33; and a deformable sensing layer coupled to the attachment at the sensing portion; Including, An elastography and / or imaging system, wherein the system is arranged such that when the device is in use, the electromagnetic radiation is transmitted through the sensing layer or the acoustic waves are transmitted through the sensing layer towards the sample material, and the sensing layer is arranged to deform when a load is applied to the sample material through the sensing layer.

35. 35. The system of claim 34, wherein the system is arranged such that the electromagnetic radiation is transmitted through the sensing layer or the acoustic waves are transmitted through the sensing layer towards the sample material, and the sensing layer is arranged to expand laterally relative to a longitudinal axis of the elastography device when the load is applied to the sample material through the sensing layer.

36. 36. The system of claim 35, wherein the attachment comprises a flexible material having a mostly incompressible volume.

37. 35. The system of claim 34, wherein the device includes an elongated probe having an end portion for transmission of electromagnetic radiation or sound waves toward the sample material, and the attachment is attached to the end portion of the elongated probe.

38. 35. The system of claim 34, wherein the sensing surface of the sensing layer is adapted for positioning in direct or indirect contact with a surface area of ​​the sample material.

39. 35. The system of claim 34, wherein the elastography device is an optical elastography device and the sensing layer has predetermined deformation-dependent optical properties.

40. 40. The system of claim 39, wherein the elastography system is arranged such that, in response to transmitting the electromagnetic radiation or acoustic waves through the sensing layer and towards the sample material, a mechanical property of the sample material is measurable by detecting electromagnetic radiation or acoustic waves transmitted from the sample material through the sensing layer.

41. 35. The system of claim 34, wherein the system is an elastography system and the device is an elastography device having a transparent portion for transmission of electromagnetic radiation or sound waves toward the sample material.

42. 42. The system of claim 41, wherein the system is an optical elastography system and the device is an optical elastography device having a transparent portion for transmission of electromagnetic radiation or acoustic waves toward the sample material.

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