Patent Grant
11883293
Some applications of the present invention relate in general to prosthetic heart valves. More specifically, some applications of the present invention relate to techniques for appropriately grouping prosthetic leaflets for use in prosthetic heart valves.
Prosthetic heart valves may be constructed of a frame to which prosthetic leaflets are attached, the leaflets providing check-valve functionality by opening in response to blood flow in a first direction, and closing in response to blood flow in a second direction. In order to inhibit leakage (“regurgitation”) of blood between the closed leaflets in the second direction, it is important that the leaflets coapt well against each other. One factor facilitating coaptation of leaflets in a prosthetic heart valve is flexibility of leaflets.
Some applications of the present invention are directed to appropriately grouping prosthetic leaflets, for use in prosthetic heart valves. Leaflet groups may be designated based on flexibility of the leaflets, e.g., such that leaflets are grouped with other leaflets that have similar flexibility. Leaflet groups typically include a fixed number of leaflets, e.g., according to the number of leaflets required for a given heart valve.
Aspects of the present invention include apparatus and methods for computationally assigning leaflet-flexibility values to leaflets, e.g., by digital analysis of one or more images of one or more pluralities of leaflets.
For some applications, an aggregate of leaflets including a first batch of leaflets and a second batch of leaflets is generated, and the groups are designated from leaflets of the aggregate based on similarity between the leaflet-flexibility values of the leaflets of the aggregate. For some such applications, the aggregate of leaflets is generated by testing each batch of leaflets, and storing each batch in a storage array in a manner that retains the individual identity of each leaflet. For some applications, the array is associated with a plurality of indicators that are activated in a manner that indicates the designated groups. For example, the array may define a plurality of cells, one cell for each leaflet of the aggregate, and one indicator for each cell.
There is therefore provided, in accordance with an application of the present invention, a method for grouping prosthetic valve leaflets of an aggregate of prosthetic valve leaflets, the method including, using a computer processor:
In an application, the method includes receiving an intra-group tolerance, the intra-group tolerance representing a maximum allowable difference between the leaflet-flexibility values of any two leaflets in a given leaflet group; and
In an application, outputting the indication of the designated leaflet groups includes, using at least one indicator in communication with the computer processor, indicating the designated leaflet groups.
In an application, the group size value is three, and receiving the group size value includes receiving the group size value that is three.
In an application, group size value is two, and receiving the group size value includes receiving the group size value that is two.
In an application, group size value is four, and receiving the group size value includes receiving the group size value that is four.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating fewer than 80 percent of the leaflets of the aggregate into designated leaflet groups.
In an application, designating fewer than 80 percent of the leaflets of the aggregate into designated leaflet groups includes designating 10-80 percent of the leaflets of the aggregate into designated leaflet groups.
In an application, designating fewer than 80 percent of the leaflets of the aggregate into designated leaflet groups includes designating fewer than 50 percent of the leaflets of the aggregate into designated leaflet groups.
In an application, designating fewer than 50 percent of the leaflets of the aggregate into designated leaflet groups includes designating 10-50 percent of the leaflets of the aggregate into designated leaflet groups.
In an application, designating fewer than 50 percent of the leaflets of the aggregate into designated leaflet groups includes designating fewer than 30 percent of the leaflets of the aggregate into designated leaflet groups.
In an application, the method includes, prior to deriving the leaflet-flexibility value for each leaflet of the aggregate of leaflets, calculating the image parameter for each leaflet of the aggregate by digitally analyzing one or more digital images that include the leaflets of the aggregate.
In an application, the method includes, prior to deriving the leaflet-flexibility value for each leaflet of the aggregate of leaflets, performing an image-quality check routine, and performing the image-quality check routine includes:
In an application:
In an application, calculating the image parameter for each leaflet of the aggregate includes calculating, for each leaflet of the aggregate, a direct distance between a position of a first leaflet-tip and a position of a second leaflet-tip.
In an application, calculating the image parameter for each leaflet of the aggregate includes calculating, for each leaflet of the aggregate, an axial distance along a horizontal axis between a position of a first leaflet-tip and a position of a second leaflet-tip.
In an application, the method includes, prior to calculating the image parameter for each leaflet of the aggregate, using an image sensor to acquire the one or more digital images.
In an application, the aggregate of leaflets includes a first batch of leaflets and a second batch of leaflets, and acquiring the one or more digital images includes:
In an application:
In an application, the method includes, subsequently to acquiring the first digital image, for each leaflet of the first batch of leaflets, indicating a respective portion of a storage array in which to temporarily store the leaflet of the first batch of leaflets.
In an application, outputting the indication of the designated leaflet groups includes indicating the respective portion of the storage array from which to group leaflets of the first batch of leaflets into the designated leaflet groups.
In an application, the method includes, prior to the step of designating:
In an application:
In an application, organizing the indices according to an order of magnitude of the values includes organizing the indices according to an ascending order of magnitude of the values.
In an application, organizing the indices according to an order of magnitude of the values includes organizing the indices according to a descending order of magnitude of the values.
In an application:
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is:
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is at least sixty percent of the stored maximum number.
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is at least seventy percent of the stored maximum number.
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is at least eighty percent of the stored maximum number.
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is at least ninety percent of the stored maximum number.
In an application, designating the at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of the designated index groups is equal to the stored maximum number.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that a total number of designated leaflet groups is at least sixty percent of the stored maximum number.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that the total number of designated leaflet groups is at least seventy percent of the stored maximum number.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that the total number of designated leaflet groups is at least eighty percent of the stored maximum number.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that the total number of designated leaflet groups is at least ninety percent of the stored maximum number.
In an application, designating at least some of the leaflets of the aggregate into designated leaflet groups includes designating the at least some of the leaflets of the aggregate into designated leaflet groups, such that the total number of designated leaflet groups is equal to the stored maximum number.
In an application:
In an application, determining whether designating the selected index group would reduce the total number of within-tolerance index groups that may be attained from the indices, compared to the maximum number, includes:
In an application, identifying the best-matching index group from the cluster of indices includes:
In an application, calculating, for each index group, the parameter, includes calculating, for each index group, a group-differential, the group-differential being a difference between (i) the leaflet-flexibility value of the highest index of the potential index group, and (ii) the leaflet-flexibility value of the lowest index of the potential index group.
In an application, calculating, for each index group, the parameter, includes calculating, for each index group, an average differential value by averaging differences between leaflet-flexibility values assigned to each pair of indices including that index group.
In an application, calculating, for each index group, the parameter, includes calculating, for each index group, a sum of a square of a difference between leaflet-flexibility values assigned to respective pairs of indices of each of a plurality of pairs of indices including the index group.
There is further provided, in accordance with an application of the present invention, a system for use with a plurality of prosthetic heart valve leaflets, the system including:
In an application, the circuitry is configured to, for each respective one of the leaflets:
In an application, the apparatus includes an image sensor in communication with the circuitry, the image sensor configured to acquire, for each respective one of the leaflets, the digital image, and to communicate the digital image to the circuitry.
In an application, the plurality of indicators include a user-interface, the user-interface configured to facilitate switching from indicating which of the cells contain leaflets designated to a first leaflet group, to indicating which of the cells contain leaflets designated to a second leaflet group.
In an application, each cell is fillable with a sterile liquid.
In an application, the plurality of indicators include a user-interface, the user-interface configured to facilitate switching from indicating the designation of at least some of the leaflets into a first leaflet group, to indicating the designation of at least some of the leaflets into a second leaflet group.
In an application, the plurality of indicators includes a respective indicator for each cell, each respective indicator an integral component of the storage array.
In an application:
In an application, each cell is labelled with a unique identifier, each unique identifier corresponding to:
In an application, the storage array includes a plurality of zones, each zone:
In an application, the storage array is configured to be placed on the plurality of indicators, such that the visual cue provided by each indicator, with respect to each leaflet, is visible through a floor of the storage array.
In an application, the plurality of indicators and the storage array are complimentarily dimensioned in a manner that facilitates integration of the storage array with the plurality of indicators, such that the visual cue provided by each indicator, with respect to each leaflet, is visible through the cell containing that respective leaflet.
There is further provided, in accordance with an application of the present invention, a method for sorting leaflets for use in prosthetic heart valves, the method including:
In an application, the method includes:
In an application, the method includes:
In an application:
In an application, the method includes, subsequently to grouping the at least some leaflets of the aggregate of leaflets into the one or more designated leaflet groups, sewing the leaflets of each designated leaflet group into a respective prosthetic heart valve.
In an application, the method includes, prior to positioning each leaflet of the first batch of leaflets opposite the image sensor:
In an application, the method includes, prior to positioning each leaflet of the first batch of leaflets opposite the image sensor:
In an application:
In an application:
In an application:
In an application, assembling the leaflets of the first batch and the leaflets of the second batch into the aggregate of leaflets includes temporarily storing each leaflet of the aggregate in the storage array in a manner that facilitates maintenance of one or more attributes selected from the group consisting of: moisture content of the leaflets, and sterility of each leaflet.
In an application, the method includes operating the software to indicate, on at least one indicator, a respective portion of the storage array in which each leaflet of the aggregate is to be temporarily stored; and
In an application:
In an application, assembling the leaflets of the first batch and the leaflets of the second batch into the aggregate of leaflets includes assembling more than forty leaflets and fewer than four hundred leaflets into the aggregate of leaflets.
In an application, assembling the leaflets of the first batch and the leaflets of the second batch into the aggregate of leaflets includes assembling more than forty leaflets and fewer than one hundred leaflets into the aggregate of leaflets.
In an application, assembling the leaflets of the first batch and the leaflets of the second batch into the aggregate of leaflets includes assembling eighty-one leaflets into the aggregate of leaflets.
In an application, operating software to output the indication of the one or more designated leaflet groups includes operating software to output the indication of the one or more designated leaflet groups on at least one indicator.
In an application, operating software to output the indication of the one or more designated leaflet groups on at least one indicator includes operating software to switch between indicating leaflets designated to a first of the designated leaflet groups, and indicating leaflets designated to a second of the leaflet groups.
In an application, operating software to output the indication of the one or more designated leaflet groups on at least one indicator, includes using a respective indicator for each leaflet of the aggregate of leaflets, operating software to output the indication of the designated leaflet group to which each leaflet of the aggregate of leaflets is designated.
In an application, using the respective indicator for each leaflet of the aggregate of leaflets, operating software to output the indication of the designated leaflet group to which each leaflet of the aggregate of leaflets is designated includes using the respective indicator for each leaflet of the aggregate of leaflets, providing a visual cue indicating the respective designated leaflet group to which each leaflet of the aggregate of leaflets is designated.
In an application, grouping the at least some leaflets of the aggregate of leaflets into the one or more designated leaflet groups, includes grouping the at least some leaflets of the aggregate of leaflets, from the storage array, into the one or more designated leaflet groups, responsively to the indication of the designated leaflet group to which each leaflet of the aggregate of leaflets is designated.
In an application:
In an application:
In an application:
There is further provided, in accordance with an application of the present invention, a method for grouping prosthetic valve leaflets of an aggregate of prosthetic valve leaflets including a first batch of prosthetic valve leaflets and a second batch of prosthetic valve leaflets, the method including:
There is further provided, in accordance with an application of the present invention, an apparatus for grouping prosthetic valve leaflets of an aggregate of prosthetic valve leaflets, the apparatus including a computer processor configured to:
There is further provided, in accordance with an application of the present invention, a computer software product including a non-transitory computer-readable medium in which program instructions are stored, which instructions, when read by a computer cause the computer to:
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
Tester 20 comprises a plurality of horizontal bars 22 movably coupled to a vertical mount 24, in accordance with some applications of the invention. Typically, and as shown, each bar 22 extends away from mount 24 (e.g., perpendicularly from the mount) along a respective bar-axis D26, each bar-axis lying on a respective vertical bar-plane D28.
Tester 20 has a first state (
As shown in
Tester 20 further comprises an image sensor 32, the image sensor positioned opposite mount 24, facing bars 22 and the mount. Orientation of image sensor 32 facing mount 24 and bars 22 facilitates the image sensor acquiring an image that includes leaflets 30 (e.g., all of the leaflets) draped over bars 22. Typically, and as shown, tester 20 further comprises a sensor-bracket 34, the sensor-bracket movably coupling image sensor 32 to the rest of tester 20 (e.g., to mount 24). Typically, sensor-bracket facilitates movement of image sensor 32 along a sensor-axis D38, moving the image sensor toward and away from mount 24. Sensor-bracket 34 typically facilitates movement of image sensor 32 (e.g., along sensor-axis D38) between (i) a position in which the image sensor can acquire an image that includes all of leaflets 30, and (ii) a position in which tester 20 is more compact—e.g., for when the tester is not in use. Typically, tester 20 is operated such that sensor 32 acquires an image that includes the multiple leaflets draped over bars 22. It is hypothesized by the inventors that acquiring and processing an image that includes multiple leaflets increases work throughput and/or improves accuracy of leaflet flexibility testing.
Typically, and as shown, mount 24 is generally flat, and bars 22 are generally parallel with each other. For some applications, mount 24 may be concave toward sensor 32, and bar-tips are arranged correspondingly to the concave surface of the mount, e.g., pointing toward the sensor. It is hypothesized by the inventors that, for some applications, mount 24 being concave may facilitate visualization of all leaflets 30 and bar-tips 68, from a single point of view—i.e., by sensor 32.
Some embodiments of the invention may comprise a plurality of image sensors 32. For example, the number of image sensors 32 may correspond to the number of bars 22.
Reference is made to
Although the Figures referred to herein depict an embodiment of tester 20 with bars 22 arranged in three rows 58 and three columns 60, this depiction is not intended to exclude other possible arrangements with either a smaller or greater number of rows 58 or columns 60 of bars 22. For some applications, and as shown, nine bars 22 may be arranged in rows 58 and columns 60 such that image sensor 32 may acquire an image including nine leaflets 30 tested simultaneously in a batch, each leaflet draped over a respective bar.
For other applications, a greater or lesser number of bars 22 may be arranged with respect to mount 24 of tester 20, facilitating increasing or decreasing the number of leaflets 30 tested simultaneously in the batch, mutatis mutandis. For some applications, the number of bars 22 (i.e. a maximum batch size) is a multiple of 3, e.g., such that all of the leaflets being tested in a single batch may be designated to leaflet groups of 3 matching leaflets, each group being used in a respective tri-leaflet prosthetic valve.
Typically, and as shown, platform 48 has an upper surface 50, the upper surface including a guide 52 that defines a guide-outline 54 corresponding to a leaflet-outline 56 of leaflet 30. In some applications, upper surface 50 at guide 52 may comprise a low-friction material. For example, the low-friction material may comprise polytetrafluoroethylene (e.g., Teflon™). Alternatively or additionally, the texture of upper surface 50 may be modified at guide 52. For example, the texture of upper surface 50 may be made to be more smooth (e.g., polished) at guide 52. The use of low-friction material and/or texture for upper surface 50 of guide 52 is hypothesized by the inventors to facilitate release of leaflet 30 from the surface as bar 22 lifts the leaflet away from the surface, thereby facilitating use of tester 20.
Reference is further made to
For some applications, leaflets 30 are non-isotropically flexible. For example, a leaflet may have a first flexibility when draped over bar 22 with a first side of the leaflet facing up, and a different flexibility when draped over the bar with the opposite side of the leaflet facing up. For such applications, leaflets 30 are typically draped over bars 22 such that they bend in the orientation in which they will bend when in use. Typically, the side of the leaflet that faces up on tester 20 is the side of the leaflet that will face upstream in the functioning prosthetic valve.
For example, leaflets 30 may comprise pericardium that has distinct sides (e.g., a rough side (e.g., a fibrous side) and a smooth side (e.g., a parietal side)). For such applications, the rough side typically faces upstream in the functioning prosthetic valve. Therefore, for such applications, it may be desirable to orient leaflets 30 upon respective guides 52 with the rough side facing upwards, such that, upon actuation of actuator, each leaflet will drape over respective bar 22 with the rough side facing upwards.
Alternatively, it may be desirable to orient leaflets 30 upon respective guides 52 with the smooth side facing upwards, such that, upon actuation of actuator, each leaflet will drape over respective bar 22 with the smooth side facing upwards. It is hypothesized by the inventors that uniform orientation of leaflets 30 upon guide 52 may increase the relevance of leaflet flexibility testing to the performance of the leaflets in the prosthetic valve.
Typically, platform 48 is disposed with respect to bar 22 such that bar-plane D28 bisects guide-outline 54 (
For some applications, mount 24 may have a strong color. For some applications, bar-tip 68 may have a second strong color. For some applications, platform 48 may have a third strong color. For example, a platform face 36 of platform 48 may have the third strong color. It is to be noted that the term “strong color” (including the specification and the claims) relates to color saturation. For example, primary colors may serve as the strong colors. The use of respective strong colors for mount 24, bar-tip 68 and/or platform face 36 is hypothesized to facilitate analysis of the image by facilitating distinction between these components and leaflet 30, and between these components and each other.
Reference is made to
As described hereinabove, image sensor 32 acquires an image that includes the plurality of leaflets 30 draped over their respective bars.
In some applications (e.g., those shown in
For some applications, circuitry 40 is not mounted on tester 20. For such embodiments, tester 20 may include an image output device (e.g., a port or wireless transceiver) 64 (
For some applications, and as described in more detail hereinbelow, circuitry 40 is further configured to assign a category to each of the leaflets, in response to the leaflet-flexibility value. Typically, and as shown in
For some applications, circuitry 40 is pre-programmed with a calibration routine, such that all leaflets 30 included in the image acquired by sensor 32 are correctly analyzed, e.g., despite each leaflet being disposed at a different position with respect to the image sensor. For some applications, the calibration routine includes acquiring an image that includes one or more (e.g., all) bar-tips 68, and analyzing the image in order to determine a position of sensor 32 with respect to the plurality of bars. For some such applications, the calibration routine is performed automatically, e.g., using the same image that includes the plurality of leaflets, which will be analyzed by circuitry 40 to derive the respective leaflet-flexibility values, as described hereinbelow. Alternatively, the calibration routine may be done separately from (e.g., prior to) placing leaflets over bars 22 of tester 20.
For some applications, sensor-bracket 34 comprises an electronic actuator, with which circuitry 40 may interface in order to move image sensor 32 (e.g., along sensor-axis D38). For some such applications, this movement is used to facilitate the calibration routine. The calibration of image sensor 32 may adjust a field of view of image sensor 32 such that the image sensor acquires an image that includes all leaflets 30.
Reference is made to
As described hereinabove, bars 22 are configured to support leaflet 30 along bar-axis D26 such that the leaflet drapes over the bar. As shown, a first-leaflet-tip 70 is disposed below the bar on a first side 72 of the bar, and a second-leaflet-tip 74 is disposed below the bar on a second side 76 of the bar. For example, first-leaflet-tip 70 may be a lowest part of leaflet 30 on first side 72, and second-leaflet-tip 74 may be a lowest part of leaflet 30 on second side 76. In some applications, circuitry 40 is configured to identify, in the acquired image, first-leaflet-tip 70 and second-leaflet tip 74, and to derive the leaflet-flexibility value at least in part responsively to a first-leaflet-tip position D96 of first leaflet tip 70 and a second-leaflet-tip position D98 of second leaflet tip 74.
Image parameters that are calculated by circuitry 40 to derive leaflet-flexibility values may include one or more of the following:
The use of a plurality of image parameters to derive leaflet-flexibility values is hypothesized by the inventors to more accurately reflect leaflet flexibility than may be derived from a single parameter. For example, a low AUC may alternatively indicate either a highly flexible or highly inflexible leaflet. The integration of AUC with direct distance D82 between first-leaflet-tip position D96 and second-leaflet-tip position D98 may aid in deriving a leaflet-flexibility value that more accurately reflects the leaflet's flexibility.
In some applications, leaflet-flexibility values may be used to facilitate sorting of the leaflets into categories of leaflet flexibility. For example, high-flexibility leaflet 30a may be assigned by tester 20 (e.g., circuitry 40 thereof) to a flexibility category “1”, moderate-flexibility leaflet 30b may be assigned to a flexibility category “2”, and low-flexibility leaflet 30c may be assigned to a flexibility category “3”- and the operator may sort the leaflets according to the assigned categories. As described hereinabove, the category for each leaflet is typically indicated by indicator 66, e.g., as shown in
Leaflets 30 may also be assigned to a “retest” category, or a “discard” category, e.g., as described hereinbelow. Typically, the process is a batch process, in which multiple leaflets are placed on tester 20, tested, and then sorted.
Leaflets that are assigned to the “retest” category may be resituated within the same or a different guide 52 for retesting (e.g., in the subsequent batch). Alternatively, leaflets 30 assigned to a “retest” category may be collected into a “retest” receptacle for subsequent retesting (e.g., in a dedicated retesting batch).
It is to be noted that, although leaflets 30 in
Circuitry 40 may be configured to categorize non-isotropically-flexible leaflets as described hereinabove, at least up to a threshold degree of asymmetric draping. For example, and as shown in
For some applications, circuitry 40 identifies non-isotropic flexibility of a leaflet 30 by calculating a difference between axial distance D92 and axial distance D94. Alternatively or additionally, circuitry 40 may identify non-isotropic flexibility of a leaflet 30 by calculating a difference between axial distance D88 axial distance D90. It is hypothesized by the inventors that a difference between D92 and D94, and/or a difference between D88 and D90, will be greater for non-isotropically-flexible leaflets than for isotropically-flexible leaflets, thereby facilitating identification of non-isotropically-flexible leaflets.
As described hereinabove, circuitry 40 may be configured to detect asymmetric draping. In that case, the asymmetric draping is asymmetric draping that is caused by, and is indicative of, non-isotropic flexibility of the leaflet. Circuitry 40 may also be configured to detect asymmetric draping that is caused by, and is indicative of, improper positioning of the leaflet being tested, e.g., caused by the operator improperly positioning the leaflet, and/or by slippage of the leaflet during elevation of the bar. In response to detection of such improper positioning, circuitry 40 typically assigns the leaflet to a “retest” category.
An exemplary reason for a leaflet to be assigned to the “retest” category is measurement error. In this context, the term “measurement error” is used to refer to situations in which image parameters and/or leaflet-flexibility values may not enable circuitry 40 to accurately assign leaflet 30 to a leaflet flexibility category. In such cases, indicator 66 may indicate a need to repeat the measurement and/or to adjust leaflet flexibility measurement conditions. For example,
For some applications, measurement error is identified in response to a difference between vertical axial distance d88 and vertical axial distance d90. For some applications, measurement error is identified in response to a difference between horizontal axial distance d92 and horizontal axial distance d94.
For some applications, circuitry 40 may detect instances of measurement error in response to a plurality of image parameters to, e.g., by cross-validation of image parameters. For example, circuitry 40 may compare a difference between D88 and D90, to a difference between D92 and D94. Alternatively or additionally, circuitry 40 may compare a difference between D88 and D92, to a difference between D90 and D94. In addition to one or both of these comparisons, circuitry 40 may also take into account direct distances D84 and D86. It is hypothesized by the inventors that the derivation of leaflet-flexibility values in response to more than one image parameter advantageously facilitates identifying measurement errors, e.g., distinguishing between (i) asymmetric draping caused by measurement error, and (ii) asymmetric draping caused by non-isotropic flexibility.
The use of a plurality of image parameters to derive leaflet-flexibility values is therefore hypothesized by the inventors to increase the validity and clinical utility of the flexibility categories to which leaflets 30 are assigned.
Reference is also made to
Typically, storage unit 110 facilitates storing leaflets 30 while maintaining: (i) moisture content of the leaflets, (ii) sterility of the leaflets, and/or (iii) separation of leaflets assigned to different leaflet-flexibility categories. In the example shown, storage unit 110 is divided into five chambers 108, of which chambers 108b, 108c, 108d are respectively dedicated to store leaflets assigned to one of the leaflet-flexibility categories described herein above (e.g. “3”, “2”, “1”). Chambers 108a and 108e are dedicated to leaflets assigned to discard categories “x” and “y”, respectively. Chamber 108f is dedicated to a “retest” category, which in this particular example is named “0”. Periodically, any leaflets present in chamber 108f may be retested, e.g., when a sufficient number of leaflets are present in the chamber.
Reference is also made to
Reference is also made to
Typically, and as shown, each leaflet flexibility category is defined by threshold leaflet-flexibility values, each threshold leaflet-flexibility value lying at a respective extreme of the category, such that each category includes leaflets with values spanning a range between the upper and lower thresholds of the category. In this way, each leaflet flexibility category spans a range of leaflet-flexibility values, each flexibility category having an upper flexibility-value threshold and a lower flexibility-value threshold. Thus, a given leaflet-flexibility value typically fits within the range defined by the upper flexibility-value threshold and the lower flexibility-value threshold of one of the leaflet-flexibility categories. For example,
For some applications, the same threshold may serve as an upper flexibility-value threshold for a first category, and as a lower flexibility-value threshold for a second category. For example, category “3” spans a range of leaflet-flexibility values between threshold D106 and threshold D112 ranging between 10 and 20, category “2” spans a range of leaflet-flexibility values between threshold D112 and threshold D118 ranging between 20 and 30, and category “1” spans a range of leaflet-flexibility values between threshold D118 and threshold D124 ranging between 30 and 40. In this way, threshold D112 serves as the upper leaflet-flexibility value of category “3”, and serves as the lower leaflet-flexibility value of category “2”. Similarly, threshold D118 serves as the upper leaflet-flexibility value of category “2”, and serves as the lower leaflet-flexibility value of category “1”.
It is to be noted that the leaflet-flexibility values and leaflet-flexibility category thresholds shown in
In
It is hypothesized by the inventors that assigning leaflets 30 to flexibility categories may enable efficient sorting of leaflets by their leaflet-flexibility values. However, for some applications, sorting leaflets purely by such a categorization technique may result in leaflets that do not necessarily have the most similar leaflet-flexibility values, being sorted into the same category. For instance,
For some applications, flexibility-value thresholds (e.g. the upper flexibility-value threshold and/or the lower flexibility-value threshold) may be adjusted responsively to leaflet-flexibility values of a plurality of leaflets. For example, the flexibility-value thresholds may be adjusted by circuitry 40 (e.g., automatically) before the leaflet-flexibility category of each leaflet is indicated. Alternatively, the flexibility-value thresholds may be manually adjusted by the operator. It is hypothesized by the inventors that adjusting flexibility-value thresholds may increase the likelihood of assigning leaflets 30 of similar flexibility to each respective leaflet flexibility category.
For some applications, circuitry 40 is configured to refer certain leaflets 30 for manual assignment (e.g., by a human specialist) to flexibility categories. For some applications, circuitry 40 may designate leaflets 30 with leaflet-flexibility values that are particularly close to the threshold values, to transition categories. For example, circuitry 40 may be configured such that each threshold has a margin, and leaflets whose leaflet-flexibility values fall within a margin of a threshold are assigned to a transition category.
For some applications, and as shown, circuitry 40 is not configured with a lower margin for threshold D106 and/or an upper margin of threshold D124. For some such applications, leaflets whose leaflet-flexibility value falls below threshold D106 or above threshold D124 are referred to a person in order to be manually assessed (e.g., to be manually assigned to a flexibility category). For some such applications, such leaflets are automatically assigned to the corresponding “discard” category “x” or “y”, e.g., to increase efficiency by reducing the likelihood of an unsuitable leaflet being referred to a specialist for manual categorization. For some such applications, leaflets whose leaflet-flexibility value falls below threshold D106 are referred to a person in order to be manually assessed, whereas leaflets whose leaflet-flexibility value falls above threshold D124 are automatically assigned to the corresponding “discard” category. For some such applications, leaflets whose leaflet-flexibility value falls above threshold D124 are referred to a person in order to be manually assessed, whereas leaflets whose leaflet-flexibility value falls below threshold D106 are automatically assigned to the corresponding “discard” category.
Alternatively, circuitry 40 is configured with a lower margin for threshold D106 and/or an upper margin of threshold D124, e.g., similarly to the margins of the other thresholds.
For some applications, tester 20 may simply indicate that a particular leaflet requires manual categorization. For some applications, tester 20 may facilitate manual categorization by indicating the categories between which the leaflet's leaflet-flexibility value falls. For example, indicator 66 of tester 20 may display “2-3” for a leaflet whose leaflet-flexibility value falls within margin 152 of the lower threshold of category 2 or within margin 154 of the upper threshold of category 3.
For some applications, transition category leaflets may be designated to be tested a second time. It is hypothesized by the inventors that: 1) manual assignment of transition category leaflets to flexibility categories, and/or 2) retesting of transition category leaflets, may increase the validity and clinical utility of leaflet flexibility categories to which leaflets 30 are assigned.
For some applications, leaflets may be designated to leaflet groups by circuitry 40 and/or by operator according to similarity of leaflet-flexibility values, e.g., without the use of flexibility categories. Leaflets 30 of the same group may then be included together in an individual prosthetic heart valve. Circuitry 40 may therefore group leaflets 30 into leaflet groups of a desirable size (e.g., leaflet groups of two leaflets for a bileaflet valve, or leaflet groups of three leaflets for a trileaflet valve). For example, in
That is, for some applications of the invention, tester 20 (e.g., circuitry 40 thereof) is configured to designate leaflets 30 (e.g., all of the leaflets that are on tester 20) into leaflet groups, based on similarity between (i) the leaflet-flexibility value of each leaflet of the plurality of leaflets, and (ii) the leaflet-flexibility value of other leaflets of the plurality of leaflets, each of the leaflet groups including a predetermined number of leaflets. For some such applications, the predetermined number of leaflets is received (e.g. as an input from the operator), using circuitry 40.
Oval 168 indicates a group of three leaflets (138, 140 and 142), which would all have been assigned to the same category (category 1) had the categorization technique had been used (e.g., as shown in
In contrast, oval 166 indicates a group of three leaflets (130, 132 and 134), in which two of the leaflets (132 and 134) would have been assigned to one category (category 2), and one of the leaflets (130) would have been assigned to a different category (category 3), had the categorization technique been used (e.g., as shown in
Reference is made to
Typically, the array is labelled to provide each of its cells with a unique identifier. Array 104 of
Array 104 has rows 112 of cells 106 labelled with letters, typically corresponding to different batches of tested leaflets 30. (A first row 112a and a second row 112b are labelled.) Within each row, cells 1-9 correspond to the nine individual leaflets 30 of the particular batch, the number signifying the bar over which each leaflet was draped during testing (e.g., according to labels 18 in
The example labelling regime of array 204 is such that each batch of leaflets is stored in a zone 214 having a number of cells 206 equal to a number of leaflets in the batch. (A first zone 214a and a second zone 214b are labelled.) Each cell of a given zone is labelled with (i) a letter that corresponds to a batch of leaflets, and (ii) a number that corresponds to the individual leaflets of that batch—e.g., signifying the bar over which each leaflet was draped during testing (e.g., according to labels 18 in
It is to be noted that the scope of the invention is not limited to alphanumerical characters, but also includes alternate methods of tracking individual identities of leaflets 30 (e.g. non-alphanumerical characters, symbols, color-coding, etc.).
For some applications, each cell 106 or 206 may be fillable with a sterile liquid (e.g. isotonic saline 16). It is hypothesized by the inventors that storage of leaflets 30 (e.g. an aggregate comprising multiple batches of tested leaflets 30) within respective storage cells 106, 206 of array 104, 204, facilitates maintenance of moisture content of the leaflets and/or sterility of the leaflets.
After multiple batches of leaflets 30 have been placed in storage array 104, 204, the leaflets are typically designated into leaflet groups, and then grouped into the leaflet groups. For some such applications, circuitry 40 designates the aggregate of leaflets into leaflet groups based on similarity between the leaflet-flexibility values of the leaflets (e.g., as described hereinbelow with reference to
For some applications, a leaflet group designation of each leaflet 30 of the aggregate of leaflets to a leaflet group, is indicated (e.g. to an operator), using at least one indicator 120, 220. For some such applications, indicator 120, 220 is configured to provide a visual cue. For example, and as shown in
For some applications, a user-interface connected to circuitry 40 (e.g. computer 100 shown in
For some applications, indicator 120, 220 is an integral component of array 104, 204.
Alternatively, and as shown, the indicator may be a discrete device, and the storage array may be juxtaposed with the indicator (e.g., placed on the indicator) such that the visual cue is visible through the array (e.g. through a floor of the array). For example, array 104, 204 may be: (i) at least partially transparent to the visual cue, and (ii) dimensioned in a manner corresponding to the dimensions of indicator 120, 220 (e.g. the indicator defines a surface upon which the array may be placed). In this way, the operator may receive the visual cue from indicator 120, 220, through array 104, 204, and group leaflets 30 from respective cells 106, 206 without cross-referencing between the storage array and a separate display representing the leaflet group designations.
For some such applications, indicator 120, 220 and array (104, 204) are complimentarily dimensioned (e.g. defining a notch and a groove), in a manner that facilitates integration of the array with the indicator such that the array is in a proper orientation with respect to the indicator. That is, proper orientation of array 104, 204 with respect to indicator 120, 220 assures that the visual cue indicated with respect to each leaflet 30, is visible through cell 106, 206 containing that respective leaflet. It is hypothesized by the inventors that integrating indicators 120, 220 into array 104, 204 reduces a risk of human error when the operator groups leaflets 30 into leaflet groups. At the same time, separability of array 104, 204 from indicator 120, 220 may facilitate successive use of multiple storage arrays (e.g. indicating leaflet group designations of multiple aggregates of leaflets to leaflet groups) with a given indicator. For some applications, the storage arrays are disposable, while the indicator is reusable.
Alternatively or in addition to facilitating step 332 by indicating the leaflets that are designated to the various leaflet groups, indicator 120, 220 may facilitate step 322 by indicating a portion of storage array 104, 204 (e.g. a cell 106, 206) in which to temporarily store leaflet 30 after testing. For example, indicator 120, 220 may be used in conjunction with the unique identifier of each cell 106, 206 described hereinabove in reference to
Reference is made to
For some applications, leaflets 30 are first assigned to categories, and are subsequently designated to leaflet groups. For such applications, (i) leaflets 30 are placed onto tester 20, tested according to the categorization technique, and sorted according to their categories—e.g., into collections, and (ii) subsequently, leaflets from a single category are re-placed onto tester and retested according to the grouping technique. It is hypothesized by the inventors that the grouping of leaflets 30 assigned to the same leaflet flexibility category, according to their leaflet-flexibility values, may enable grouping of leaflets into leaflet groups of highly similar flexibility.
For some applications, leaflets assigned to a leaflet-flexibility category (e.g. a first categorized batch of categorized leaflets and a second categorized batch of categorized leaflets sorted into storage unit 110) undergo a second iteration of flexibility testing. In the second iteration of testing, the categorized leaflets are retested, in order to be designated to leaflet groups, as described hereinabove. In this way, assigning leaflets 30 to categories may serve as a preliminary screening of leaflets of an initial stock (see arrows in
Reference is made to
In order to use tester 20, multiple leaflets 30 are draped over respective bars 22 of the tester (step 310). However, several optional steps may be performed beforehand (indicated by broken boxes).
In optional steps 302 and 304, leaflets of a stock of leaflets 30 are initially classified according to their thickness (step 302), and are then selected according to their thickness (step 304), such that the leaflets that will be tested using tester 20 are of a single thickness class. For such applications, the testing using tester 20 may represent a second, “fine” classification according to flexibility of leaflets 30, subsequent to an initial “coarse” classification according to their thickness. It is hypothesized by the inventors that performing flexibility testing on leaflets that have already been pre-classified to a single thickness may further improve the matching of leaflets for use in a prosthetic valve.
Alternatively or in addition to initially classifying leaflets 30 according to their thickness, method 300 may be performed using leaflets previously assigned to a leaflet-flexibility category, e.g., as described hereinabove in reference to
In optional step 306, image sensor 32 may be (re)positioned prior to testing leaflets 30 on tester 20 (e.g., as described hereinabove).
In optional step 308, circuitry 40 is activated to perform a dedicated calibration routine prior to placing leaflets over bars 22 of tester 20 (e.g., as described hereinabove). (For some applications, a calibration is alternatively or additionally performed as part of the subsequent image analysis of step 318.)
After leaflets 30 have been placed across bars 22 (step 310), the bars are lifted with respect to platform 48, such that leaflets 30 drape over the bars (step 312). The operator then initiates acquisition (step 314) of a digital image by image sensor 32 (step 316), the image including the multiple leaflets draped over bars 22.
Typically, at this stage, circuitry 40 performs analysis of the acquired image (step 318), the analysis typically comprising calculating one or more image parameters and deriving, for each leaflet 30, a leaflet-flexibility value, e.g., as described hereinabove.
For some applications, circuitry 40 performs an image-quality check routine (step 320), which may be part of image analysis (step 318), or may be a distinct step. For some such applications, the image-quality check routine is run prior to deriving the leaflet-flexibility value for each leaflet. For some applications, the image-quality check routine comprises calculating, for each leaflet, an image parameter. For example, the parameter derived in the image-quality check routine may be direct distance D82 between a first-leaflet-tip position and a second-leaflet-tip position (
For some applications, an image passes the image-quality check routine if the image parameter was successfully calculated for all of the leaflets in the image. Examples of why an image might fail the image-quality check routine include an unclear image, an obstacle obscuring one or more of the leaflets, improperly placed leaflets, failure of circuitry 40 to identify both leaflet-tips of a leaflet, and/or an unexpected or illogical image parameter value.
In the case that the image fails the image-quality check, leaflets 30 are placed again across bars 22 (e.g., placement of the leaflets is adjusted), the bars are re-lifted, and the image is re-acquired. In the case that the image passes the image-quality check, the plurality of leaflets are typically stored in a manner that facilitates tracking of the individual identity of the leaflets, e.g., by placing the leaflets in storage array 104, 204 (step 322).
If additional batches of leaflets 30 are to be tested (step 324), steps 310-322 are repeated for the additional leaflets (e.g. until storage array 104, 204 is full, or until all the leaflets have been tested). Thus, an aggregate of leaflets comprising multiple batches of leaflets is assembled on the array. Typically for such applications, the aggregate comprises at least 9 and/or fewer than 400 leaflets, e.g., 9-400 leaflets (e.g., 9-100 leaflets or 40-400 leaflets), such as 40-100 leaflets. For example, and as shown, the aggregate may comprise eighty-one leaflets. For some applications, the entire aggregate of leaflets is tested before circuitry 40 designates the leaflets into leaflet groups. It is hypothesized by the inventors that testing flexibility of the aggregate of leaflets 30, before designating the batches of leaflets into leaflet groups, increases the likelihood of designating closely matched leaflets to each group.
Although method 300 is described hereinabove (and is shown in
Typically, while the aggregate of leaflets 30 is stored in storage array 104 or 204, the leaflets are designated to respective leaflet groups (step 326), based on similarity between the respective leaflet-flexibility values of each leaflet of the aggregate of leaflets.
Typically, grouping is optimized responsively to two criteria: (i) As many leaflets as possible from the aggregate of leaflets should be designated to a leaflet group (i.e., maximizing yield and/or minimizing wastage). (ii) Leaflets designated to a leaflet group should have the most similar leaflet-flexibility values attainable (e.g. the leaflets should be “best-matching” leaflets). Thus, ideally, a maximal number of best-matching leaflets is desired. There is typically a trade-off between these criteria. If an intra-group tolerance is very low (e.g., only the very best matched leaflets are designated to a group), a total number of within-tolerance (i.e. a yield of) leaflet groups may be unacceptably low. Similarly, ensuring a maximal yield of complete leaflet groups may require designating, to the same group, leaflets that are insufficiently similar to each other. Described hereinbelow, with reference to
Typically, designating leaflets 30 to leaflet groups is accomplished without further moving or otherwise manipulating the leaflets (e.g. while the leaflets are stored in storage array 104, as described hereinabove in reference to
In response to this indicating, the operator can then group the leaflets (i.e., physically gather the leaflets) into groups (step 332) and utilize the groups of leaflets (step 336), e.g. by assembling the leaflets together in a prosthetic heart valve.
As described hereinabove with respect to step 326, the intra-group tolerance determines which leaflets may be designated into groups with which other leaflets. Typically, this means that the flexibility value of each leaflet within a group must, at a minimum, be within the intra-group tolerance to the flexibility value of each other leaflet within that group. Intra-group tolerances are typically received (e.g. as input from operator), using circuitry 40, and are described in more detail hereinbelow.
Reference is made to
As described hereinbelow in greater detail with respect to
Typically, and as shown, indices are arranged according to an order (e.g. according to an order of magnitude of their values). For other applications, it may not be necessary to order the indices. Step 402 is therefore indicated as being optional by the broken box in
Next, a maximum number of index groups that conform to the intra-group tolerance (henceforth “within-tolerance” index groups), which may be attained from the series of indices, is determined (step 404). For some applications, an index group conforms to the intra-group tolerance if (i) it includes a predetermined number of indices whose values fit within an intra-group tolerance, and (ii) the flexibility value of each index of the index group is within the intra-group tolerance with respect to the leaflet-flexibility value of each other index of index group. That is, the intra-group tolerance defines a maximum allowable difference between values of a within-tolerance index group. Step 404 is also described in greater detail with respect to
Subsequently, the indices are designated to index groups (step 406). As described hereinbelow in greater detail with respect to
However, if doing so would reduce the total number of within-tolerance groups, compared to the maximum number determined in step 404, then an iterative process is performed, testing next-best-matching leaflets until the grouping does not reduce the total number of within-tolerance groups.
Leaflet-flexibility values are obtained, e.g. using circuitry 40 (step 502). For example, the leaflet-flexibility values may be retrieved from the memory of circuitry 40, e.g., after having been derived as described hereinabove. Alternatively or in addition, the leaflet-flexibility values may be entered by the operator (e.g. using a user-interface).
The leaflet-flexibility values are then arranged, in order of magnitude, as a series of indices (step 504), which will subsequently be analyzed. Typically, circuitry 40 assigns a respective index number to each of the leaflet-flexibility values. As shown in
For example, and shown in
Together, steps 502 and 504 of method 500 may correspond to step 402 of method 400. That is, step 402 may comprise steps 502 and 504.
Subsequently, the maximum number of index groups that may be attained from the series of indices is determined (step 404). Each index group comprises a predetermined number of indices. In the description hereinbelow, the predetermined number of indices in an index group is three (corresponding to three leaflets of a leaflet group). Therefore, the term “trio” is used henceforth as a specific example in reference to
Each designated index group conforms to a predetermined intra-group tolerance. That is, all of the indices within an index group must have a value that is within the intra-group tolerance of all of the other indices within the index group. Therefore, each index group must, at a minimum, (i) contain the predetermined number of indices, and (ii) contain only indices that are within the intra-group tolerance of each other.
In the example shown, the intra-group tolerance is defined as 2. Thus, indices having values differing by no more than two may be included in a trio.
Determining the maximum number of within-tolerance trios (step 404) begins with selection of a potential trio (step 505), starting at a first trio T1, which includes indices i1, i2, and 3 (
For some applications, an index group-differential (e.g. an index trio-differential), equal to a difference between a highest value of the trio, and a lowest value of the trio, is calculated in order to determine whether the trio conforms to the intra-group tolerance (step 506). If the trio-differential is equal to, or less than the intra-group tolerance, then the trio is considered to conform to the intra-group tolerance, and is therefore counted as a within-tolerance trio. For applications in which the indices are sorted according to ascending order of magnitude, trio-differential “delta_t” value of the trio is calculated by subtracting the first index of the trio from the last index of the trio.
The next step in determining the maximum number of within-tolerance trios is to determine whether sufficient subsequent indices remain in order for a subsequent potential trio to be evaluated (step 508). If the answer is “yes” (as in this case, since at least), analysis continues by advancing one index (step 509) in the series, and potential trio T2 is selected (step 505,
Again, sufficient subsequent indices remain in order for a subsequent potential trio to be evaluated (step 508). That is, at least one index has yet to be selected. The analysis therefore continues by advancing one index in the series (step 509), and potential trio T3 is selected (step 505). As shown in
After within-tolerance trio T3 is counted, sufficient subsequent indices still remain in order for a subsequent potential trio to be evaluated (step 512). The analysis therefore continues by advancing along the indices (step 513).
Since trio T3 was counted as conforming to the intra-group tolerance, the analysis advances by three indices (as opposed to by one index in cases in which the trio did not conform to the intra-group tolerance). That is, because indices i3, i4, and i5 already belong to a within-tolerance trio, no other trios that include any of these three indices are evaluated in step 404. Therefore, method 400 then returns to step 505, as described hereinabove, mutatis mutandis, with the next potential trio to be evaluated being T6. That is, the “current index” of step 505 at this stage will be i6.
In this way, successive iterations are performed, determining the number of within-tolerance trios, until no trios remain to be evaluated.
Each of the trios that would have been evaluated are indicated by a broken rectangle. Those of the trios that conformed to the intra-group tolerance are indicated by the broken rectangle being bolded. As shown, in this exemplary series, the maximum number of trios that conform to the intra-group tolerance that it is possible to obtain from the series is found to be five. At this point, this maximum number is stored, hereafter the “stored maximum number,” e.g. in the memory of circuitry 40 (step 514).
Together, steps 505, 506, 508, 509, 510, 512, 513, and 514 of method 500 may correspond to step 404 of method 400. That is, step 404 may comprise steps 505, 506, 508, 509, 510, 512, 513, and 514.
After the maximum number of trios that conform to the intra-group tolerance, that are attainable from the series is determined and stored (step 404), the indices are designated to index groups (step 406), as elaborated hereinbelow.
Firstly, a preliminary index group (e.g. first trio T1) is selected for evaluation (step 516). Trio T1 is found to not conform to the intra-group tolerance (step 517,
Since there is at least one remaining unevaluated trio (step 519), analysis continues by advancing one index (step 521) to trio T2 (step 516,
The next preliminary index group, trio T2, is also found to not conform to the intra-group tolerance (step 517,
Since there is at least one remaining unevaluated trio (step 519), analysis continues by advancing one index (step 521) to the next preliminary index group, trio T3 (step 516,
Trio T3 is found to conform to the intra-group tolerance, and is therefore found to be a within-tolerance trio (step 517) labelled with a bolded broken rectangle in
The cluster typically comprises the within-tolerance trio (in this case T3) and the subsequent two indices (in this case T4 and T5). This can also be stated as the cluster comprising the within-tolerance trio (in this case T3, which corresponds to index i3), and subsequent trios that correspond to the other indices contained within the within-tolerance trio (in this case T4 and T5). More generally stated (e.g., to encompass group sizes other than 3), the cluster typically comprises the within-tolerance index group (i.e., the index group that was found to conform to the tolerance in step 517) and the index groups that correspond to the other indices contained within the within-tolerance index group. Therefore, the number of index groups in the cluster is equal to the number of indices comprising each index group—e.g., the number of leaflets that will be combined in a prosthetic valve.
For the purposes of selecting the best-matching trio of cluster C3 (step 518), the delta_t value (as described hereinabove in reference to
For example, and as shown in
For some applications, other parameters may be calculated in order to identify the best-matching trio of a cluster by comparing the closeness of fit between the leaflets comprising each trio of the cluster.
For some such applications, an additive differential value may be calculated. The additive differential (“sum_delta_t”) of a particular trio is the sum of the differences between each of the three pairs of indices within that trio. For example, the additive differential of trio T3 (sum_delta_t3) is calculated as (i4−i3)+(i5−i4)+(i5−i3)=(26−25)+(27−26)+(27−25)=1+1+2=4.
For some applications (e.g. if the predetermined index group size is two or three), the sum_delta_t values of index groups may be equal to the delta_t values of those same index groups. For other applications (e.g. if the predetermined index group size is four or greater), the sum_delta_t values of index groups may not equal the delta_t values of those index groups. For some such applications, sum_delta_t values may reflect, more accurately than delta_t values, the degree to which leaflet-flexibility values of leaflets within a given leaflet group match each other. It is therefore hypothesized by the inventors that using sum_delta_t values may be particularly advantageous when identifying the best-matching index group within a of indices, for applications in which the predetermined index group size is four or greater.
Alternatively or in addition, an average differential (“avg_delta_t”) of a particular index group may be calculated to compare the closeness of fit between the indices within each index group of the cluster, by averaging the differences between each of the pairs of indices within that index group. For example, avg_delta_t3 may be calculated as (1+1+2)/3=1.33.
Alternatively or in addition, a sum of the squares of the differences between (sum{circumflex over ( )}_delta_t) each of the pairs of indices within that index group may be calculated to compare the closeness of fit between the index within each index group of the cluster. For example, sum{circumflex over ( )}_delta_t3 may be calculated as 1{circumflex over ( )}2+1{circumflex over ( )}2+2{circumflex over ( )}2=6. It is to be noted that the scope of the present invention also includes the use of other appropriate mathematical functions to represent the respective differentials of the index groups.
Evaluation of cluster C3 continues by determining whether designating the best-matching trio of the cluster (in this case T5) as an index group to be subsequently indicated in step 328 (
Since at least another trio of indices remains to be evaluated (step 526), the analysis continues by advancing three indices—i.e., to the trio that corresponds to the first index after previously-designated trio T5 (step 528). Therefore, in this case, trio T8 (which includes indices i8, i9, and i10) is selected for evaluation (step 516). Trio T8 is found to be a within-tolerance trio, (step 517,
The next step is therefore determining whether designating best-matching trio T10 would reduce the total number of within-tolerance trios to below the maximum number that was determined in step 404 (step 520). Thus, the number of additional within-tolerance trios that may be attained from the remainder of the series is calculated in the same manner described hereinabove, mutatis mutandis, but starting after hypothetically-designated trio T10. As shown in
As shown in
It is worth noting that in this illustrative example using indices i1-i23, the leaflet-flexibility values are integers, which increases the likelihood that two trios of the same cluster may have identical trio-differentials. However, in reality, leaflet-flexibility values typically include decimals or fractions (i.e., leaflet-flexibility values are typically “floats”), reducing the likelihood of two trios having identical trio-differentials.
For some applications in which a next-best-trio must be identified from among two trios having equal trio-differentials, the trio appearing later in the series of indices (e.g. trio T9,
As shown in
As shown in
Since at least another trio of indices remains to be evaluated (step 526), the analysis continues by advancing three indices—i.e., to the trio that corresponds to the first index after previously-designated trio T8 (step 528). Therefore, in this case, trio T11 (which includes indices i11, i12, and i13) is selected for evaluation (step 516).
For some applications, remaining indices are identified by advancing along the indices, such that steps 512 and 513 may be combined. That is, whether sufficient subsequent indices remain in order for a subsequent potential trio to be evaluated, is determined (step 512) by attempting to advance three indices (step 513). For example, successful advancement by three indices demonstrates that sufficient indices remain in order for a subsequent potential trio to be evaluated. In contrast, failure to advance by three indices demonstrates that insufficient indices remain in order to evaluate a subsequent potential trio. However, for the sake of clarity, advancing three indices (step 513) and determining if sufficient indices remain in order to do so (step 512) are described as discrete steps. Similarly, additional pairs of steps (e.g., steps 508 and 509, steps 519 and 521, steps 526 and 528) may each respectively be combined. For the sake of clarity, these pairs of steps are described hereinabove as discrete steps.
As described hereinabove in reference to
Together, steps 516, 517, 518, 519, 520, 521, 522, 524, 526, and 528 of method 500 may correspond to step 406 of method 400. That is, step 406 may comprise steps 516, 517, 518, 519, 520, 521, 522, 524, 526, and 528.
In this way, successive iterations of step 406 are performed, until no trios remain to be evaluated.
It is to be noted that, in some instances (e.g., due to an aggregate of leaflets having leaflets whose leaflet-flexibility values are of a particular similarity and/or order), it may be possible that the cumul_avg_delta_t value of the designated trios is equal to the cumul_avg_delta_t value of the within-tolerance index groups.
The designated index groups are then indicated (step 328 of
In the example shown, of the 23 indices visible in
For some applications, it may be desirable to adjust the intra-group tolerance used as a basis for designating the index groups, e.g., in order to obtain a desirable (e.g., optimal) compromise between yield and closeness of fit within index groups. This is represented in
Reference is now also made to
For some such applications, the operator selects one of the alternate yields, such that the operator has the option of revising the intra-group tolerance by selecting an alternate yield stemming from an intra-group tolerance other than the predetermined tolerance. For example, the intra-group tolerance may be increased responsively to designating an undesirably low yield of within-tolerance leaflet groups stemming from use of the predetermined tolerance with a particular aggregate of leaflets.
For some applications, it may be desirable to include, alongside alternate numbers of within-tolerance leaflet groups, a parameter reflecting the average closeness of fit of each alternate leaflet group yield. In addition to the relationship between intra-group tolerance and the yield of leaflet groups shown in
Responsively to the operator's election whether to revise the tolerance in step 330, the final designation (e.g. identities of trios of leaflets) are then indicated to the operator (step 328), who then groups the leaflets (step 332), responsively to the final leaflet group designations. Further typically for such applications, if the operator selects the leaflet group designation resultant from the predetermined intra-group tolerance, this designation is indicated to the operator, effectively skipping over optional step 330. For some applications, step 330 is skipped entirely, and the leaflet group designation indicated in step 328 is the designation stemming from the predetermine intra-group tolerance in step 326.
For some applications, grouped leaflets 30 undergo a validation step 334, subsequently to being grouped into their leaflet groups. For example, although leaflets 30 would have already been typically tested for flexibility in a first orientation (e.g. with the rough side facing upwards), it may be desirable to validate the leaflets by testing the leaflets of a leaflet group, in a second orientation that is inverted with respect to the first orientation (e.g. with the smooth side facing upwards).
For example, validation may entail repeating steps 310-322, mutatis mutandis, with leaflets 30 draped across bars 22 in the second orientation. For example, after calculating first-orientation image parameters by digitally analyzing a first-orientation digital image of leaflets in the first orientation, resulting in a first leaflet-flexibility value (steps 310-318), second-orientation image parameters may be calculated by digitally analyzing a second-orientation digital image of leaflets 30 in the second orientation, resulting in a second leaflet-flexibility value.
For example, a leaflet 30 may pass validation if the second leaflet-flexibility value is deemed to be sufficiently similar to the first leaflet-flexibility value. This comparison may be made by a human operator or by circuitry 40. For example, a difference between the first leaflet-flexibility value and the second leaflet-flexibility value may be calculated, such that the leaflet may be counted as validated if the difference is below a predetermined threshold. Alternatively or in addition, the comparison may be facilitated by calculating a symmetry index reflective of the degree to which the first leaflet-flexibility value correlates with the second leaflet-flexibility value.
Leaflets 30 that fail validation are typically discarded. For some applications, the user-interface may be used to indicate to the user which leaflets failed the validation, such that those failed leaflets may be discarded.
If a leaflet of a designated trio of leaflets fails the validation, that leaflet is typically discarded. For some applications, step 326 is then repeated on the entire aggregate but excluding the failed leaflet and its flexibility value. Alternatively, the validated leaflets of the failed leaflet's group (and which are now “orphaned”) may be stored for future use (e.g., to be evaluated in another aggregate).
Step 336 represents the utilization of the groups of leaflets, e.g. by assembling the leaflets together in a prosthetic heart valve, or by storing the group of leaflets in a separate container for later use. This step may be performed by the individual who evaluated the leaflets. Alternatively or in addition, step 336 comprises sending the groups of leaflets to a distinct individual, e.g. who assembles the leaflets together in a prosthetic heart valve.
Hereinabove, the group size is described in general as being equal to the number of leaflets that are to be used in (e.g., sewn into) a given prosthetic heart valve (e.g., a group size of three for a trileaflet valve). For some applications, the group size may be larger than the number of leaflets that are to be used in a given prosthetic heart valve, e.g., so as to provide a spare leaflet in case a problem (e.g., damage) occurs to one of the leaflets of a given group, e.g., so that it is not necessary to discard all the leaflets of a group in response to a problem with only one of the leaflets of the group. For example, a group size of four may be used when grouping leaflets for trileaflet valves.
Applications of the invention described herein can take the form of a computer program product accessible from a computer-usable or computer-readable medium (e.g., a non-transitory computer-readable medium) providing program code for use by or in connection with a computer or any instruction execution system, such as circuitry 40.
For some applications, the designating of leaflets 30 to groups is facilitated by an artificial neural network, e.g., with the artificial neural network performing step 326 and/or method 400. For some such applications, training data (e.g. digital images, image parameters, and/or leaflet-flexibility values) are used in conjunction with leaflet group designations described hereinabove.
For some applications in which leaflets 30 are designated to leaflet groups using an artificial neural network, steps 326 and 330 may be performed by the artificial neural network, after which final results are indicated (step 328) to the operator. For some such applications, the trade-off described hereinabove between achieving a maximal number of within-tolerance leaflet groups and each leaflet group including “best-matching” leaflets, is considered by the artificial neural network. It is hypothesized by the inventors that using the artificial neural network to consider the aforementioned trade-off may assist the operator in deciding whether or not to adjust intra-group tolerances (step 330). It is further hypothesized by the inventors that performance of step 330 by the artificial neural network may at least partially obviate specialized medical or technical training of the operator.
For the purpose of this description, a computer-usable or computer readable medium can be any apparatus that can comprise, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium. Typically, the computer-usable or computer readable medium is a non-transitory computer-usable or computer readable medium.
Examples of a computer-readable medium include a semiconductor or solid-state memory, magnetic tape, a removable computer diskette, a random-access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W) and DVD. For some applications, cloud storage, and/or storage in a remote server is used.
A data processing system suitable for storing and/or executing program code will include at least one processor (e.g., circuitry 40) coupled directly or indirectly to memory elements through a system bus. The memory elements can include local memory employed during actual execution of the program code, bulk storage, and cache memories which provide temporary storage of at least some program code in order to reduce the number of times code must be retrieved from bulk storage during execution. The system can read the inventive instructions on the program storage devices and follow these instructions to execute the methodology of the embodiments of the invention.
Network adapters may be coupled to the processor to enable the processor to become coupled to other processors or remote printers or storage devices through intervening private or public networks. Modems, cable modem and Ethernet cards are just a few of the currently available types of network adapters.
Computer program code for carrying out operations of the present invention may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the C programming language or similar programming languages.
It will be understood that the methods described herein can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general-purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer (e.g., circuitry 40) or other programmable data processing apparatus, create means for implementing the functions/acts specified in the methods described in the present application.
These computer program instructions may also be stored in a computer-readable medium (e.g., a non-transitory computer-readable medium) that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instruction means which implement the function/act specified in the methods described in the present application. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the methods described in the present application.
Circuitry 40 typically comprises a hardware device programmed with computer program instructions to produce a computer processor. For example, when programmed to perform the methods described herein, the computer processor typically acts as a special purpose computer processor. Typically, the operations described herein that are performed by computer processors transform the physical state of a memory, which is a real physical article, to have a different magnetic polarity, electrical charge, or the like depending on the technology of the memory that is used.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
This application is a Continuation of U.S. Ser. No. 17/307,176 to Kislev et al., filed on May 4, 2021, entitled “LEAFLET-GROUPING SYSTEM,” which issued as U.S. Pat. No. 11,491,011, and which is a Continuation of U.S. Ser. No. 16/937,216 to Kislev et al., filed on Jul. 23, 2020, entitled “LEAFLET-GROUPING SYSTEM,” which issued as U.S. Pat. No. 11,026,792, and which is a Continuation-in Part-of: (i) PCT application IL2020/050315, to Kislev et al., filed on Mar. 17, 2020, and entitled “LEAFLET-GROUPING SYSTEM” which published as WO 2021/186424, and(ii) PCT application IL2019/051031, to Kislev et al., filed on Sep. 16, 2019, and entitled “LEAFLET-TESTING APPARATUS”, which published as WO 2020/058972 and which claims priority from, and is a Continuation of, U.S. patent application Ser. No. 16/132,937 filed Sep. 17, 2018, and entitled “LEAFLET-TESTING APPARATUS” which issued as U.S. Pat. No. 10,779,946. Each of the above applications is incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20230218399 A1 | Jul 2023 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17307176 | May 2021 | US |
| Child | 17956319 | US | |
| Parent | 16937216 | Jul 2020 | US |
| Child | 17307176 | US | |
| Parent | 16132937 | Sep 2018 | US |
| Child | PCT/IL2019/051031 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/IL2020/050315 | Mar 2020 | US |
| Child | 16937216 | US | |
| Parent | PCT/IL2019/051031 | Sep 2019 | US |
| Child | PCT/IL2020/050315 | US |
