GB2558924A

GB2558924A - Method and apparatus for providing a quantitative volumetric assessment of organ health

Info

Publication number: GB2558924A
Application number: GB1701005.9A
Authority: GB
Inventors: Kelly Matthew; Brady Michael; Mavar Haramija Marija
Original assignee: Perspectum Diagnostics Ltd
Current assignee: Perspectum Ltd
Priority date: 2017-01-20
Filing date: 2017-01-20
Publication date: 2018-07-25
Anticipated expiration: 2037-01-20
Also published as: WO2018134357A1; GB201701005D0; SG11201906295RA; CA3050176C; GB2558924B; US11200974B2; EP3554350A1; MY196405A; CN110234270A; CN110234270B; CA3050176A1; JP7244425B2; US20190378606A1; AU2018209225B2; GB2558924A9; NZ755057A; JP2020506753A; AU2018209225A1

Abstract

A method of providing a quantitative volumetric assessment of organ (such as a liver for example) health comprises obtaining a volumetric map 110 of organ health comprising information defining a state of tissue health across at least part of an organ, receiving input defining at least one organ section 125 , determining an assessment organ volume 130 based at least partly on the at least one defined organ section, calculating an organ-viability measure 135 for the assessment organ volume based at least partly on information within the volumetric map defining the state of tissue health across the organ volume, and outputting an indication of the organ-viability measure 150. The method may comprise inputting a user-defined region of interest, and the functional organ model may be based on Couinaud classification. The state of tissue health may be measured at multiple discrete locations within the organ, and these results averaged or interpolated to determine the whole organ health. An apparatus for carrying out the method is disclosed. The method and apparatus are suitable for monitoring conditions such as non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or hepatocellular carcinoma (HCC) and for identifying the functional liver remnant (FLR) prior to removal.

Description

(71) Applicant(s):

Perspectum Diagnostics Ltd.

Oxford Centre for Innovation, New Road, OXFORD, ΟΧ1 1BY, United Kingdom (72) Inventor(s):

Matthew Kelly Michael Brady Marija Mavar Haramija (74) Agent and/or Address for Service:

Optimus Patents Limited

Peak Hill House, Steventon, BASINGSTOKE,

Hampshire, RG25 3AZ, United Kingdom (51) INT CL:

A61B 5/00 (2006.01) (56) Documents Cited:

US 6366797 B1 US 20160338874 A1

US 20160335770 A1 US 20140371570 A1 US 20140330106 A1

Pavlides et. al. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease Journal of Hepatology 2016 vol. 64 j 308 31 (58) Field of Search:

INT CL A61B, G06T

Other: WPI, EPODOC, INSPEC, BIOSIS, MEDLINE (54) Title of the Invention: Method and apparatus for providing a quantitative volumetric assessment of organ health

Abstract Title: Method and apparatus for providing a quantitative volumetric assessment of organ health (57) A method of providing a quantitative volumetric assessment of organ (such as a liver for example) health comprises obtaining a volumetric map 110 of organ health comprising information defining a state of tissue health across at least part of an organ, receiving input defining at least one organ section 125 , determining an assessment organ volume 130 based at least partly on the at least one defined organ section, calculating an organ-viability measure 135 for the assessment organ volume based at least partly on information within the volumetric map defining the state of tissue health across the organ volume, and outputting an indication of the organ-viability measure 150. The method may comprise inputting a user-defined region of interest, and the functional organ model may be based on Couinaud classification. The state of tissue health may be measured at multiple discrete locations within the organ, and these results averaged or interpolated to determine the whole organ health. An apparatus for carrying out the method is disclosed. The method and apparatus are suitable for monitoring conditions such as non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or hepatocellular carcinoma (HCC) and for identifying the functional liver remnant (FLR) prior to removal.

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- 1 Title: METHOD AND APPARATUS FOR PROVIDING A QUANTITATIVE VOLUMETRIC ASSESSMENT OF ORGAN HEALTH

Description

Field of the invention

This invention relates to a method and apparatus for providing a quantitative volumetric assessment of organ health, and in particular to a method and apparatus for providing a preintervention quantitative volumetric assessment of post-intervention organ health.

Background of the invention

Liver resection (removal of all or part of the liver by surgery) is the treatment of choice for curing cancer in the liver, whether due to primary liver cancers such as hepatocellular carcinoma (HCC) or metastatic disease from other sites, for example colorectal cancer (CRC). Advances in surgical technique planning have made curative liver surgery available to increasingly more patients.

Liver resection is currently the only curative option for HCC, the most common primary liver cancer. However, the greater the extent of liver surgery the greater the risk of complications, which can include death. Liver resection is associated with a high rate of post-operative morbidity (up to 50%) with a mean length of hospital stay after resection of 10 days and patients with diseased livers have longer recovery periods.

Typically, a surgeon will aim to leave at least one third of the liver volume post resection since, in general, one third of a healthy liver is sufficient to support life. However, the rising prevalence of obesity has resulted in an increased proportion of the population having nonalcoholic fatty liver disease (NAFLD) and its more serious subtype, non-alcoholic steatohepatitis (NASH). If a patient undergoing liver resection has a background of liver disease (such as NAFLD or NASH), they will require a larger proportion of liver volume post resection to support life due to the reduced liver function. If too much liver is removed, the patient will require intensive care to compensate for insufficient liver volume.

The liver is unique in its capacity to withstand surgery and regenerate post-operatively. However, a minimum functional liver remnant (FLR) is required in order for patients to survive the initial peri-operative period. At present, the assessment of the FLR is based solely on volume, in the context of clinical judgment and surrogate markers of liver health (blood tests). There is a clear need for a direct measurement of liver health, so that volume and function can be combined. For example, surgery with a predicted FLR of 21% might be survivable if the liver tissue was in extremely good health; whereas surgery with a predicted FLR of 40% might be lethal if the liver tissue was in poor health.

Whilst surgery is the primary approach to curing liver cancer, recent innovations in nonresectional interventions such as Trans-Arterial Chemoembolization (TACE) and radiofrequency ablation (RFA) have demonstrated increasing effectiveness. In fact, TACE is performed more

-2frequently in primary liver cancers than surgery. Since such interventions effectively destroy a portion of the liver, consideration of FLR health is also essential in such non-resectional interventions.

While one characteristic of poor liver health, hepatic steatosis, can be determined by noninvasive imaging techniques, steatohepatitis has been shown to be a more important predictor of morbidity. Conventional clinical practice for diagnosing liver disease such as NASH requires an invasive liver biopsy. In addition to the risks associated with biopsy (pain, bleeding), there is an inherent sampling error with only 0.002% of the liver volume evaluated rendering it especially problematic in heterogeneous (regionally-varying) disease.

In addition to the above liver-related issues, partial resections can also be performed on, for example, a patient’s pancreas or kidney, which can also suffer from inflammation and fibrosis. Accordingly, consideration of the health of other organs such as kidneys and pancreases may also beneficial prior to undertaking resections/interventions in relation to those organs.

Thus, there is a need for a means for providing a quantitative volumetric assessment of the health of a patient’s organ prior to surgery that enables the clinical outcome of surgery to be improved and a reduction in post-intervention (including post-operative and post non-operative, e.g. non-resectional, intervention) morbidity and costs.

Summary of the invention

According to example embodiments of a first aspect of the invention there is provided a method of providing a quantitative volumetric assessment of organ health. The method comprises obtaining a volumetric map of organ health comprising information defining a state of tissue health across at least part of an organ, receiving input defining at least one organ section, determining an assessment organ volume based at least partly on the at least one defined organ section, calculating an organ-viability measure for the assessment organ volume based at least partly on information within the volumetric map defining the state of tissue health across the organ volume, and outputting an indication of the organ-viability measure.

In this manner, a user (e.g. a clinician) is able to provide input to define an assessment organ volume representative of, for example, an anticipated post-intervention organ volume (e.g. an anticipated viable organ volume remaining following resectional surgery or non-resectional interventions). A volumetric map of organ health may then be used to provide a pre-intervention quantitative volumetric assessment of organ health for the anticipated post-intervention organ volume by way of an organ-viability measure. Thus, pre-intervention quantitative information on post-intervention organ health may be provided to, for example, surgeons and interventional radiologists prior to performing any intervention, enabling them to improve surgical/intervention outcomes and to reduce post-surgical/intervention morbidity and cost. In particular, such an assessment is achieved in a non-invasive manner, and enables surgery and/or interventions to be tailored to the individual patient based on the overall health of the patient’s organ.

In some optional embodiments, the method may comprise aligning the volumetric map of organ health to a functional organ model (for example, the Couinaud model of hepatic segments),

-3receiving the input from the user defining at least one section of the functional organ model, and determining the assessment organ volume based at least partly on the at least one defined functional organ model section.

In some optional embodiments, the method may further comprise displaying a graphical representation of the functional organ model to the user, and receiving the input from the user defining the at least one organ section in relation to the displayed graphical representation of the function organ model. For example, such a functional organ model may be based on the Couinaud classification of organ anatomy.

In some optional embodiments, the volumetric map of organ health may comprise information defining a state of tissue health for each of a plurality of locations throughout the at least part of the organ, said information comprising at least one of:

an indication of pathologies present within the respective location of the organ; and a health score representative of pathologies present within the respective location of the organ.

In some optional embodiments, the step of calculating the organ-viability measure for the assessment organ volume may comprise calculating an average location health score for all locations within the assessment volume based on information within the volumetric map defining the state of tissue health across the organ volume, and calculating the organ-viability measure for the assessment organ volume based on the average location health score and the assessment organ volume size.

In some optional embodiments, the average location health score for all locations within the assessment volume may comprise identifying pathologies present within each location based on information within the volumetric map defining the state of tissue health across the organ volume, for each location summing weighting values for pathologies identified within that location, and calculating the average location health score based on the summed weighting values for all locations within the assessment volume.

In some optional embodiments, the assessment organ volume may comprise one of: the at least one defined organ section; and the remaining organ volume excluding the at least one defined organ section.

In some optional embodiments, the method may comprise generating the volumetric map of organ health based on received data indicating the presence of pathologies within locations of at least a part of the organ.

In some optional embodiments, the method may further comprise performing interpolation of the received data indicating the presence of pathologies within locations of the organ to derive indications of the presence of pathologies within locations throughout the whole organ, and generating the volumetric map of organ health based on the derived indications of the presence of pathologies within locations throughout the whole organ.

In some optional embodiments, the step of generating the volumetric map of organ health may comprise identifying pathologies present within individual locations of the organ, for each of said locations summing weighting values for pathologies identified within that location to derive a

-4location health score, and generating the volumetric map of organ health comprising the derived location health scores.

In some optional embodiments, outputting the indication of the organ-viability measure may comprise one or more of:

displaying the organ-viability measure to a user;

storing the organ-viability measure in at least one data storage device; and transmitting the organ-viability measure to at least one external device.

According to example embodiments of a second aspect of the invention there is provided an apparatus for providing a quantitative volumetric assessment of organ health, the apparatus comprising at least one processing component arranged to perform the method of the first aspect of the invention.

In some optional embodiments, the at least one processing component may comprise one or more of:

one or more programmable components arranged to execute computer program code for performing one or more of the steps of the method of the first aspect of the invention; and hardware circuitry arranged to perform one or more of the steps of the method of the first aspect of the invention.

In some optional embodiments, the apparatus may further comprise at least one output component for outputting the indication of the organ-viability measure. The at least one output component may comprise one or more of:

a display device for displaying the organ-viability measure to a user; a data storage device for storing the organ-viability measure; and an interface component for transmitting the organ-viability measure to at least one external device.

Brief description of the drawings

Further details, aspects and embodiments of the invention will be described, by way of example only, with reference to the drawings. In the drawings, like reference numbers are used to identify like or functionally similar elements. Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale.

Figure 1 illustrates a simplified flowchart of an example of a method of providing a quantitative volumetric assessment of organ health for planned/anticipated organ treatment.

Figure 2 illustrates a simplified flowchart of an example of a method of calculating an organviability measure when the volumetric map of organ health comprises information defining an indication of pathologies present within each location of the organ.

Figure 3 illustrates a simplified flowchart of an example of a method of calculating an organviability measure when the volumetric map of organ health comprises a health score representative of pathologies present within each location of the organ.

-5Figure 4 illustrates a simplified flowchart of an example of a method of generating a volumetric map of organ health comprising information defining an indication of pathologies present within each location of the organ.

Figure 5 illustrates a simplified flowchart of an example of a method of generating a volumetric map of organ health comprising a health score representative of pathologies present within each location of the organ.

Figure 6 illustrates a simplified block diagram of an example of apparatus that may be adapted in accordance with examples of the present invention for providing a quantitative volumetric assessment of organ health.

Detailed description of the preferred embodiments

The present invention will now be described with reference to the accompanying drawings in which there is illustrated an example of a method and apparatus for providing a pre-intervention quantitative volumetric assessment of post-intervention organ health. However, it will be appreciated that the present invention is not limited to the specific examples herein described and as illustrated in the accompanying drawings and that various modifications and alternatives may be implemented without departing from the inventive concept.

Furthermore, because the illustrated embodiments of the present invention may for the most part, be implemented using electronic components and circuits known to those skilled in the art, details will not be explained in any greater detail than that considered necessary as illustrated below, for the understanding and appreciation of the underlying concepts of the present invention and in order not to obfuscate or distract from the teachings of the present invention.

Referring now to Figure 1, there is illustrated a simplified flowchart 100 of an example of a method of providing a quantitative volumetric assessment of post-intervention organ health for planned/anticipated organ treatment. The method of Figure 1 starts at 105 and moves on to 110 where a volumetric map of organ health for an organ, for example a liver, is obtained. The volumetric map of organ health comprises information defining a state of tissue health across at least part of the organ. For example, the volumetric map of organ health may comprise information defining a state of tissue health for each of a plurality of locations throughout the organ.

In some example embodiments, such information for a location within the organ may comprise an indication of pathologies present within that location of the organ. Examples of pathologies that may be present within, for example, a liver, and thus that may be indicated within the volumetric map information, include:

steatosis (the abnormal retention of fats and other lipids within a cell);

inflammation (the increased movement of plasma and white blood cells into the tissue);

fibrosis (the formation of excess fibrous connective tissue); and cirrhosis (scarring of the liver tissue).

Each individual ‘location’ of the organ may be representative of, for example, a voxel of a medical scan image of the organ, such as an MRI scan, CT scan, fused imaging data set (e.g. PET-CT) etc. As such, each location of the organ may be representative of, for example, a 2mm²

-6section of a 2-D medical scan slice through the organ having a certain slice ‘thickness’, and thus be representative of a volume comprising many cells. Accordingly, multiple pathologies may be present within the region of the organ represented by an individual location for which information is provided within the volumetric map of organ health. Thus, in some example embodiments, the information within the volumetric map of organ health for a location within the organ may comprise an indication of the presence of one or more pathologies, or in the case of a healthy region of organ an indication of the presence of no pathologies.

In some alternative embodiments, the information within the volumetric map of organ health for a location within the organ may comprise a health score representative of pathologies present within the respective location of the organ. For example, and as described in greater detail below with reference to Figure 5, such a location health score may be derived based on pathologies present within that location, with different pathologies being assigned different weighting values, and the location health score being derived based on the sum of the weighted values for pathologies present within the location. It will be appreciated that alternative approaches to computing a representation of combined information about a plurality of pathologies may equally be used to derive a location health score, and the approaches herein described are only intended to be exemplary and not limiting.

Referring back to Figure 1, having obtained the volumetric map of the organ health, the method moves on to 115 where in the illustrated example the volumetric map of organ health is aligned to a functional organ model. One example of such a functional liver model is the Couinaud classification of liver anatomy, which uses the vascular supply in the liver to separate the liver into eight functional segments. Such a functional liver model is typical relied upon by surgeons and interventional radiologists for planning and during surgery/intervention to determine the extent of the surgery/intervention. Such alignment may be achieved by way of performing registration, for example deformable registration, between the volumetric map of organ health and the functional organ model to align the data set of the volumetric map of organ health into the volumetric coordinate system of the functional organ model. Image registration is a well-known process within the art, with many different, well-known techniques available for performing such an alignment of datasets. Accordingly, such alignment will not be described in any further detail herein.

By aligning the volumetric map of organ health to such a function organ model, the information within the volumetric map of organ health defining the state of tissue health can be directly linked to the function organ model during planning etc. of organ surgery/intervention.

In the example illustrated in Figure 3, having aligned the volumetric map of organ health to the functional organ model, the method moves on to 120 where in the example of Figure 3 a graphical representation of the functional organ model is displayed to a user. In this manner, the user is able to visualise a model of the organ and to interact with the model for the purpose of surgery/intervention planning, including selecting/defining sections of the organ. In the illustrated example, input from the user defining one or more sections of the functional organ model are then received at 125, for example defining one or more organ sections in relation to the displayed graphical representation of the functional organ model. However, it is contemplated that such input

-7defining one or more sections of the organ may alternatively be automatically generated, and thus it will be appreciated that the present invention is not limited to such input being provided by a user. The sections defined by the received input may relate to functional sections of the organ defined by the functional organ model, for example the eight functional segments defined by the Couinaud classification system. Additionally/alternatively one or more sections defined by the received input may relate to a part of such a function section, referred to as a ‘wedge’ in resection surgery.

An assessment organ volume is then defined 130 based on the received input from the user. For example, such input from the user may define one or more sections to be removed/ablated during surgery/intervention. Accordingly, the assessment organ volume may be determined to comprise those sections of the functional organ model not defined by the received input. Alternatively, the input from the user may define one or more sections of the organ to remain postsurgery/intervention. Accordingly, the assessment organ volume may be determined to comprise those sections defined by the received input.

Having determined the assessment organ volume, the method moves on to 135 where an organ-viability measure for the assessment organ volume is calculated based at least partly on information within the volumetric map of organ health. Example methods of calculating an organviability measure for an assessment organ volume are described below with reference to Figures 2 and 3.

Having calculated the organ-viability measure for the assessment organ volume, the method moves on to 140 where an indication of the calculated organ-viability measure is provided to a user. Such an indication may be provided in any suitable manner. For example, the organ-viability measure may be displayed to the user as a numeric value, or by way of a graphical representation (e.g. colour/shade) applied to the functional organ model displayed to the user. Additionally/alternatively the organ-viability measure may be compared to one or more threshold value(s) representative of a viable organ assessment volume and an indication of whether the organ-viability measure is above or below the threshold value(s) may be displayed to the user. Such an indication of whether the organ-viability measure is above or below the threshold value may be displayed to the user may be represented by way of a numeric value or word, or by a colour applied to the graphical representation of the functional organ model displayed to the user.

In the example illustrated in Figure 1, the user is provided with an opportunity to modify the defined sections at 145. If the user selects to modify the defined sections, the method loops back to 125 where (further) input from the user one or more (modified) section(s) is received. Conversely, if no modifications to the defined sections are required by the user, the method moves on to 150 where in the illustrated example the defined organ sections and at least an indication of the calculated organ-viability measure are output. Outputting of the indication of the organ-viability measure and the defined organ sections may comprise one or more of:

displaying the organ-viability measure to a user;

The method of Figure 1 then ends, at 155.

-8Figure 2 illustrates a simplified flowchart 200 of an example of a method of calculating an organ-viability measure when the volumetric map of organ health comprises information defining an indication of pathologies present within each location of the organ. The method of Figure 2 starts at 205 and moves on to 210 where weighting values for pathologies are determined. For example, such pathologies weighting values 215 may be predefined and retrieved from a data storage device. Additionally/alternatively, such pathologies weighting values 215 may be manually entered by a user. In the illustrated example, a scaling factor for the weighting values is then determined at 220, for example to normalise a subsequently calculated organ-viability score to a pre-defined range (e.g. a range from 0 to 1). Such a scaling factor may be determined by summing the weighting values and dividing a top-end range value (e.g. 1) by the summed value. A first location within the assessment volume is then selected at 225.

Pathologies present within the selected location are identified at 230 based on the information for that location contained within the volumetric map of organ health. The weighted values for the pathologies identified as being present within the selected location are summed at 235. In the illustrated example, the scaling factor determined at 220 is then applied to the summed weighting values at 240 to derive a location health score. It is then determined whether location health scores have been derived for all locations within the assessment volume at 245. If it is determined that location health scores have not been derived for all locations within the assessment volume, the next location is selected at 250 and the method loops back to 230.

When it is determined that location health scores have been derived for all locations within the assessment volume at 245, the method moves on to 255 where an average location health score for all locations within the assessment volume is calculated. The organ-viability score for the assessment volume is then calculated at 260 based on the average location health score and the assessment organ volume size, for example the absolute size of the assessment organ volume or a relative size assessment organ volume (e.g. as a percentage or ratio of the full organ volume). The method then ends at 265.

As described above, in some example embodiments the volumetric map of organ health may alternatively comprise a health score representative of pathologies present within each location of the organ. Figure 3 illustrates a simplified flowchart 300 of an example of a method of calculating an organ-viability measure when the volumetric map of organ health comprises a health score representative of pathologies present within each location of the organ. The method of Figure 3 starts at 310 and moves on to 355 where an average location health score for all locations within the assessment volume is calculated based on the health scores for those locations within the volumetric map of organ health. The organ-viability score for the assessment volume is then calculated at 360 based on the average location health score and the assessment organ volume size, for example the absolute size of the assessment organ volume or a relative size assessment organ volume (e.g. as a percentage or ratio of the full organ volume). The method then ends at 365.

In accordance with some embodiments, it is contemplated that the step of obtaining a volumetric map of organ health may comprise generating the volumetric map of organ health based

-9on received data indicating the presence of pathologies within locations of at least a part of the organ. For example, the severity of fibrotic or cirrhotic disease in an organ can in certain situations be assessed using elastography-based techniques. These techniques use ultrasound or magnetic resonance imaging (MRI) based methods to measure organ stiffness, a surrogate for fibrotic or cirrhotic disease. Such elastographic techniques have demonstrated value in identifying advanced organ disease. Furthermore, hepatic steatosis can be determined by non-invasive imaging techniques, with MRI being the most accurate. The Applicant’s LiverMultiScan (LMS) technology, an MRI-based technology that has gained FDA 510(k) clearance and CE marking to aid clinicians in the diagnosis of early liver disease, uses technology to measure and correct MRI-derived T1 maps of the liver for the presence of hepatic iron, a common co-morbidity in patients with chronic liver disease. In addition to corrected T1 mapping, the Applicant’s LMS technology also quantifies hepatic steatosis (fat) and haemosiderosis (iron) using state of the art MRI acquisition and processing techniques. Accordingly, data indicating the presence of pathologies within locations within a liver may be obtained by way of such MRI-based technology.

Figure 4 illustrates a simplified flowchart 400 of an example of a method of generating a volumetric map of organ health. The method starts at 405 and moves on to 410 where data indicating the presence of pathologies within locations of at least a part of the organ is received. For example, such information may identify pathologies detected within individual voxels of one or more MRI scan data sets, and said voxels may thus establish at least an initial set of locations for which the presence of pathologies are indicated in the resulting volumetric map of organ health. It is contemplated that such data may relate to only portions of the organ, and not the organ as a whole. Accordingly, in the illustrated example interpolation of the received data is performed at 415 to derive data indicating of the presence of pathologies within locations throughout the whole organ. In the example illustrated in Figure 4, a volumetric map of organ health is then generated at 465 comprising information defining an indication of pathologies present within each location of the organ. The method then ends at 470.

Figure 5 illustrates a simplified flowchart 500 of an alternative example of a method of generating a volumetric map of organ health. The method starts at 505 and moves on to 510 where data indicating the presence of pathologies within locations of at least a part of the organ is received. In the illustrated example interpolation of the received data is performed at 515 to derive data indicating the presence of pathologies within locations, or the distribution of pathologies, throughout the whole organ. In the example illustrated in Figure 5, the method then moves on to 520 where weighting values for pathologies are determined. For example, such pathologies weighting values 525 may be predefined and retrieved from a data storage device. Additionally/alternatively, such pathologies weighting values 525 may be manually entered by a user. In the illustrated example, a scaling factor for the weighting values is then determined at 530. Such a scaling factor may be determined by summing the weighting values and dividing a top-end range value (e.g. 1) by the summed value. A first location within the assessment volume is then selected at 535.

-10Pathologies present within the selected location are identified at 540 based on the (interpolated) data for that location. The weighted values for the pathologies identified as being present within the selected location are summed at 545. In the illustrated example, the scaling factor determined at 530 is then applied to the summed weighting values at 550 to derive a location health score. It is then determined whether location health scores have been derived for all locations within the organ 555. If it is determined that location health scores have not been derived for all locations within the organ, the next location is selected at 560 and the method loops back to 540.

When it is determined that location health scores have been derived for all locations within the assessment volume at 555, the method moves on to 565 where a volumetric map of organ health is then generated at 465 comprising a health score representative of pathologies present within each location of the organ. The method then ends at 570.

Advantageously, embodiments of the present invention enable medical imaging, such as MRI imaging, to be used to provide a non-invasive, pre-intervention quantitative volumetric assessment of post-intervention organ health, helping doctors personalise their treatment plans to individual patients. In particular, medical imaging may be used to generate a volumetric map of organ health. A user (e.g. a clinician) is then able to provide input to define an assessment organ volume representative of a planned post-intervention organ volume (e.g. an anticipated functioning organ volume remaining following resectional surgery or non-resectional interventions). The volumetric map of organ health may then be used to provide a quantitative volumetric assessment of post-intervention organ health for the planned post-intervention organ volume by way of the organ-viability measure. Thus, quantitative pre-operative information on organ health may be provided to, for example, surgeons and interventional radiologists, enabling them to improve surgical/intervention outcomes and to reduce post-surgical morbidity and cost. In particular, such an assessment is achieved in a non-invasive manner, and enables surgery and/or interventions to be tailored to the individual patient based on the overall health of the patient’s organ.

Although example embodiments have been described in relation to providing preintervention quantitative volumetric assessment of post-intervention organ health, it is contemplated that the present invention may equally be implemented post-intervention to provide a post-intervention quantitative volumetric assessment of organ-health. Such a post-intervention assessment may be beneficial when, for example, a planned intervention has had to be dynamically adapted mid-intervention due to unforeseen circumstances. Accordingly, such a postintervention assessment enables a surgeon or interventional radiologist to assess the postintervention organ health following such an un-planned intervention.

Whilst references to a liver have been made in relation to the above described method of providing a quantitative volumetric assessment of organ health, it is to be understood that the present invention is not limited to being implemented in relation to providing a quantitative volumetric assessment of liver health, and it is contemplated that the present invention may be directed to providing a quantitative volumetric assessment of the health of other organs such as, for example, pancreases, kidneys, etc.

-11 Figure 6 illustrates a simplified block diagram of an example of apparatus 600 that may be adapted in accordance with examples of the present invention for providing a quantitative volumetric assessment of organ health. The apparatus 600 comprises one or more processing components 610 arranged to perform various processing functions to implement a method of providing a quantitative volumetric assessment of organ health, for example in accordance with one or more of the methods illustrated in Figures 1 to 5 and as hereinbefore described. In some example embodiments, one or more of the processing components 610 may comprise one or more programmable components, for example one or more processor cores, arranged to execute computer program code for performing one or more of the steps of such a method. Additionally/alternatively, at least one of the processing components may comprise a hardware processing component arranged to perform one or more of the steps of such a method, such as an application specific integrated circuit (ASIC) device or hardware accelerator module comprising hardware circuity arranged to perform predefined processing of data provided thereto.

The apparatus 600 further comprises one or more memory elements 620. The memory elements) 620 may consist of one or more non-transitory computer program products such as, for example, a hard disk, an optical storage device such as a CD-ROM device, a magnetic storage device, a Read Only Memory, ROM, a Programmable Read Only Memory, PROM, an Erasable Programmable Read Only Memory, EPROM, an Electrically Erasable Programmable Read Only Memory, EEPROM, and a Flash memory, etc. The memory element 620 may additionally/alternatively comprise one or more volatile memory elements such as, for example, Random Access Memory (RAM), cache memory, etc.

For simplicity and ease of understanding, a single processing device 610 and a single memory element 620 will hereinafter be referred to. However, it will be appreciated that such references to a single processing device 610 or a single memory element 620 are intended to encompass multiple processing devices 610 and multiple memory elements 620 respectively.

The memory element 620 may have stored therein executable computer program code to be executed by the processing device 610. The memory element 620 may further have stored therein data to be accessed and/or processed by the processing device 610 when executing computer program code.

The apparatus 600 illustrated in Figure 6 further comprises one or more output devices, indicated generally at 630. Such output devices may comprise, by way of example, a display device, a printer device, a network interface device, etc. The apparatus 600 illustrated in Figure 6 further comprises one or more user input devices, indicated generally at 640. Such input devices may include, byway of example, a keyboard, a keypad, a mouse, a touchscreen, etc.

In accordance with some examples of the present invention, the processing device 610 is arranged to obtaining a volumetric map of organ health comprising information defining a state of tissue health across at least part of an organ, receiving input from a user defining at least one organ section, determining an assessment organ volume based at least partly on the at least one defined organ section, calculating an organ-viability measure for the assessment organ volume

-12based at least partly on information within the volumetric map defining the state of tissue health across the organ volume, and outputting an indication of the organ-viability measure.

As described above, the invention may also be implemented in a computer program for running on a computer system, at least including code portions for performing steps of a method according to the invention when run on a programmable apparatus, such as a computer system or enabling a programmable apparatus to perform functions of a device or system according to the invention.

A computer program is a list of instructions such as a particular application program and/or an operating system. The computer program may for instance include one or more of: a subroutine, a function, a procedure, an object method, an object implementation, an executable application, an applet, a servlet, a source code, an object code, a shared library/dynamic load library and/or other sequence of instructions designed for execution on a computer system.

The computer program may be stored internally on a tangible and non-transitory computer readable storage medium or transmitted to the computer system via a computer readable transmission medium. All or some of the computer program may be provided on computer readable media permanently, removably or remotely coupled to an information processing system. The tangible and non-transitory computer readable media may include, for example and without limitation, any number of the following: magnetic storage media including disk and tape storage media; optical storage media such as compact disk media (e.g., CD-ROM, CD-R, etc.) and digital video disk storage media; non-volatile memory storage media including semiconductor-based memory units such as FLASH memory, EEPROM, EPROM, ROM; ferromagnetic digital memories; MRAM; volatile storage media including registers, buffers or caches, main memory, RAM, etc.

A computer process typically includes an executing (running) program or portion of a program, current program values and state information, and the resources used by the operating system to manage the execution of the process. An operating system (OS) is the software that manages the sharing of the resources of a computer and provides programmers with an interface used to access those resources. An operating system processes system data and user input, and responds by allocating and managing tasks and internal system resources as a service to users and programs of the system.

The computer system may for instance include at least one processing unit, associated memory and a number of input/output (I/O) devices. When executing the computer program, the computer system processes information according to the computer program and produces resultant output information via I/O devices.

In the foregoing specification, the invention has been described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications and changes may be made therein without departing from the scope of the invention as set forth in the appended claims and that the claims are not limited to the specific examples described above.

Those skilled in the art will recognize that boundaries between the above described operations merely illustrative. The multiple operations may be combined into a single operation, a

-13single operation may be distributed in additional operations and operations may be executed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be altered in various other embodiments.

Also for example, the examples, or portions thereof, may implemented as soft or code representations of physical circuitry or of logical representations convertible into physical circuitry, such as in a hardware description language of any appropriate type.

Also, the invention is not limited to being implemented in computer program code, and may equally be implemented, at least partly, by way of physical devices or units implemented in nonprogrammable hardware, as well as in programmable devices or units able to perform the desired device functions by operating in accordance with suitable program code, such as mainframes, minicomputers, servers, workstations, personal computers, notepads, personal digital assistants, electronic games, automotive and other embedded systems, cell phones and various other wireless devices, commonly denoted in this application as ‘computer systems’.

However, other modifications, variations and alternatives are also possible. The specifications and drawings are, accordingly, to be regarded in an illustrative rather than in a restrictive sense.

In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word ‘comprising’ does not exclude the presence of other elements or steps then those listed in a claim. Furthermore, the terms ‘a’ or ‘an,’ as used herein, are defined as one or more than one. Also, the use of introductory phrases such as ‘at least one’ and ‘one or more’ in the claims should not be construed to imply that the introduction of another claim element by the indefinite articles ‘a’ or ‘an’ limits any particular claim containing such introduced claim element to inventions containing only one such element, even when the same claim includes the introductory phrases ‘one or more’ or ‘at least one’ and indefinite articles such as ‘a’ or ‘an.’ The same holds true for the use of definite articles. Unless stated otherwise, terms such as ‘first’ and ‘second’ are used to arbitrarily distinguish between the elements such terms describe. Thus, these terms are not necessarily intended to indicate temporal or other prioritization of such elements. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage.

Claims

1. A method of providing a quantitative volumetric assessment of organ health; the method comprising:

obtaining a volumetric map of organ health comprising information defining a state of tissue health across at least part of an organ, receiving input defining at least one organ section, determining an assessment organ volume based at least partly on the at least one defined organ section, calculating an organ-viability measure for the assessment organ volume based at least partly on information within the volumetric map defining the state of tissue health across the organ volume, and outputting an indication of the organ-viability measure.

2. The method of Claim 1, wherein the method comprises:

aligning the volumetric map of organ health to a functional organ model;

receiving the input from the user defining at least one section of the functional organ model;

and determining the assessment organ volume based at least partly on the at least one defined functional organ model section.

3. The method of Claim 2, wherein the method further comprises displaying a graphical representation of the functional organ model to the user, and receiving the input from the user defining the at least one organ section in relation to the displayed graphical representation of the function organ model.

4. The method of Claim 2 or Claim 3, wherein the functional organ model is based on the Couinaud classification of organ anatomy.

5. The method of any one of the preceding Claims, wherein the volumetric map of organ health comprises information defining a state of tissue health for each of a plurality of locations throughout the at least part of the organ, said information comprising at least one of:

6. The method of any one of the preceding Claims, wherein the step of calculating the organviability measure for the assessment organ volume comprises:

calculating an average location health score for all locations within the assessment volume based on information within the volumetric map defining the state of tissue health across the organ volume; and

-15calculating the organ-viability measure for the assessment organ volume based on the average location health score and the assessment organ volume size.

7. The method of Claim 6, wherein the average location health score for all locations within the assessment volume comprises:

identifying pathologies present within each location based on information within the volumetric map defining the state of tissue health across the organ volume;

for each location summing weighting values for pathologies identified within that location; and calculating the average location health score based on the summed weighting values for all locations within the assessment volume.

8. The method of any one of the preceding Claims, wherein the assessment organ volume comprises one of:

the at least one defined organ section; and the remaining organ volume excluding the at least one defined organ section.

9. The method of any one of the preceding Claims, wherein the method comprises generating the volumetric map of organ health based on received data indicating the presence of pathologies within locations of at least a part of the organ.

10. The method of Claim 9, wherein the method further comprises performing interpolation of the received data indicating the presence of pathologies within locations of the organ to derive indications of the presence of pathologies within locations throughout the whole organ, and generating the volumetric map of organ health based on the derived indications of the presence of pathologies within locations throughout the whole organ.

11. The method of Claim 9 or Claim 10, wherein the step of generating the volumetric map of organ health comprises:

identifying pathologies present within individual locations of the organ;

for each of said locations summing weighting values for pathologies identified within that location to derive a location health score; and generating the volumetric map of organ health comprising the derived location health scores.

12. The method of any one of the preceding Claims, wherein outputting the indication of the organviability measure comprises one or more of:

displaying the organ-viability measure to a user;

13. An apparatus for providing a quantitative volumetric assessment of organ health; the apparatus comprising at least one processing component arranged to perform the method of any one of the preceding Claims.

-1614. The Apparatus of Claim 13, wherein the at least one processing component comprises one or more of:

one or more programmable components arranged to execute computer program code for 5 performing one or more of the steps of the method of any one of Claims 1 to 12; and hardware circuitry arranged to perform one or more of the steps of the method of any one of

Claims 1 to 12.

15. The apparatus of Claim 13 or Claim 14, wherein the apparatus further comprises at least one 10 output component for outputting the indication of the organ-viability measure, the at least one output component comprising one or more of:

a display device for displaying the organ-viability measure to a user; a data storage device for storing the organ-viability measure; and an interface component for transmitting the organ-viability measure to at least one external 15 device.

Intellectual

Property

Office

Application No: GB1701005.9 Examiner: Mr Michael Collett