The present invention relates to a computational method and computer products for calculating the proximal and distal ends of a device of interlaced threads (or interlaced device) with one or more sections with a singularity, before being positioned in a vascular structure. The invention allows knowing the configuration the interlaced device will adopt before it is implanted. The invention also allows calculating the local porosity of the device after it is implanted/positioned.
By singularity it should be understood a point, or section, along the longitudinal direction of the interlaced device, where multiple (at least three) of the interlaced filaments/threads coincide. That is, because of the singularity/singularities the interlaced device is “closed” at some point where (all or at least most of) the threads converge. The device can be closed at one of its ends, at both ends, or in more sites.
Examples of interlaced devices are those used in the treatment of vascular pathologies when deployed inside a vessel. More particularly, examples of devices of this type are the intrasaccular devices described in patent application US 20120283768-A1 and in U.S. Pat. No. 10,136,896-B2.
Likewise, a tool which allows a user to manually position a device with singularities inside vascular models, but without simulating the deployment method is disclosed in papers [1] and [2]. This tool is based on deformation by means of a spring model.
Furthermore, U.S. Pat. No. 10,176,566-B2 proposes a method for determining the final length of a stent before the positioning thereof in a vascular structure. The present invention extends and adapts what is described in this US patent.
Likewise, the US 2019038358-A1 provides a method of estimating the length of a stent. Unlike present invention, the stent of this US patent application does not have any singularity in the end sections thereof.
Therefore, new methods which allow calculating the final positions of interlaced devices with one or more singularities are required.
To that end, embodiments of the present invention provide according to a first aspect a method for calculating the proximal and distal ends (i.e. the final positions) of an interlaced device before being positioned in a vascular structure. The method comprises performing the following steps by a computer including one or more processors and at least one memory:
If the singularity of the interlaced device is at the distal end, the method further comprises extracting a morphological descriptor md of the vascular structure at the distal point Pd and comparing said morphological descriptor md with a nominal morphological descriptor Mn of a distal section of the interlaced device including the singularity. Then, a point Pa is defined as Pa=Pd.
In the event that the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method further comprises:
In the event that the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn, the method comprises selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is the minimum height, over the traced central line, achieved by said distal section, corresponding to the height of the distal section being in the configuration corresponding to the nominal morphological descriptor Mn (i.e. the nominal configuration, where the interlaced device is open to its maximum diameter, without constraints. Indeed, dmin is a constant determined by the design of the device).
In contrast, if the singularity is at the proximal end, the method further comprises:
Then, a point Pa is defined as Pa=Pd, and a point Pdm that is located an interval md from the distal point Pd and on a plane perpendicularly intersecting the traced central line at the distal point Pd is identified.
In the event that the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method further comprises:
In the event that the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn, the method comprises selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is the minimum height, over the traced central line, achieved by said proximal section, corresponding to the height of said proximal section being in the configuration corresponding to the morphological descriptor md.
In one embodiment, the interlaced device has a singularity in the proximal section and a singularity in the distal section, therefore the calculation of the proximal and distal ends of the interlaced device is performed for both proximal and distal sections, according to the steps described above. In this case, however, the distal point Pd of the proximal section is defined as the proximal point Pp of the distal section.
In one embodiment, the interlaced device further has a (tubular-shaped) central section. The traced central line of the vascular structure is also divided into different segments. The method in this case further comprises:
wherein if said new nominal height is greater than 0, steps xi) to xiii) are repeated for the segment contiguous to the preceding segment, moving forward in the proximal direction, and if the new nominal height is approximately 0, all the lengths of each segment are added together, this sum being the final height of the interlaced device after its positioning.
In one embodiment, the interlaced device is attached to a second interlaced device (of the same diameter) at either the proximal end or distal end thereof. The second interlaced device can include a singularity in its proximal section, in its distal section, or in both. In this case, the proposed method comprises performing the calculation of the proximal and distal ends of the second interlaced device according to the steps described above, depending on where the singularity/singularities is/are located.
According to the proposed method, the morphological descriptors md and ma can include: the minimum radius of the cross-section of the vasculature perpendicular to the central line, or the maximum radius, or the radius of the equivalent circumference with the perimeter equal to the cross-section perpendicular to the central line, or the radius of the equivalent circumference with an area equal to the cross-section perpendicular to the central line, among others.
In one embodiment, the method further comprises calculating the porosity on the entire surface of the interlaced device. To that end, the method comprises:
In the previous embodiment, all the portions can have the same or a different size. In particular, the number of portions is equal to the number of threads.
Other embodiments of the invention disclosed herein also include computer program products for performing the steps and operations of the proposed method in the first aspect of the invention. More particularly, a computer program product is an embodiment having a computer-readable medium including computer program instructions encoded therein which, when executed in at least one processor of a computer system, cause the processor to perform the operations indicated herein as embodiments of the invention.
The present invention thus provides a fast method to simulate intra-sacular devices inside the patient anatomy that allows knowing, in a quick and precise way, how a specific device size adapts to the aneurysm morphology. That is, the present invention allows knowing, before being implanted, the final arrangement of a device with singularities when it is positioned inside an aneurysm. This involves, in addition to the possibility of evaluating the apposition with respect to the walls of the aneurysm achieved by the device, the location of the proximal end thereof inside the aneurysm. This location is important because it helps the neurointerventionalist to make decisions about the device that is to be used. The device is ideally expected to completely and safely cover the neck of the aneurysm to interrupt the blood flow inside the aneurysm.
The foregoing and other features and advantages will be better understood from the following merely illustrative and non-limiting detailed description of several embodiments in reference to the attached drawings, in which:
The present invention provides a method for calculating the final position of interlaced devices with one or more singularities. The selection of an appropriate endosaccular device size is crucial for a successful treatment and strongly depends of the final configuration that the device adopts when it adapts to the aneurysm sac morphology. This is frequently a problem during the intervention, leading to replacement of the device, reopening of the aneurysm or a need for re-treatment. A technique that allows predicting the released device configuration before intervention provides a powerful computational tool to aid the interventionist during device selection.
The method is based on the analysis of the local morphology of the region to be treated, more specifically on the analysis of how the interlaced device is deformed as it adapts to the local morphology of the vessel, for example an aneurysm. The morphological description of the aneurysm and the descriptive specifications of the interlaced device design (height, diameter, amount of threads, etc.) are also preferably taken into account by the proposed method.
In reference to
The interlaced device 1 of
It should be noted that the proposed method is generic and can be simplified to as many sections as desired; in fact, it is only necessary for one of the ends 101, 103 of the interlaced device 1 to include a singularity. The interlaced device 1 can also be attached to a second interlaced device through the proximal end 103 or distal end 101.
In this case, it is only necessary for contiguous sections to coincide with one another in type (singularity or open) and in size (the same diameters). The interlacing configuration and design that the threads of the interlaced device 1 have in each of its sections, particularly in the proximal and distal sections 103S, 101S, can thereby especially be considered.
In the interlaced device 1, the threads in the sections 101S, 103S with singularities extend radially, all of said threads being attached to a point referred to as the hub, located on axis 104 of the interlaced device 1. The threads in these sections 101S, 103S are constituted by adopting a sinusoidal shape in the radial direction when the interlaced device is deployed outside the catheter. The position of the threads in the radial direction can be exemplified using a sinusoidal function for the interlaced device 1. Nevertheless, other functions such as a sinusoidal function with an exponential decay, a logarithmic function, a catenary function, an exponential function, etc., could also be used.
Local morphology of the vessel can be quantified using morphological descriptors that are computed semi-automatically using state-of-the-art software.
In this description, the term “nominal morphological descriptor Mn” is used to refer to the magnitude achieved by a descriptor of the morphology of the interlaced device 1, such as radius or height, when the device is released outside of a vascular structure or of the positioning device (catheter). This configuration of the interlaced device 1 is referred to as the nominal (free) configuration. Therefore, for example, if the radius is considered as a morphological descriptor of the interlaced device 1, the nominal radius is the radius it will adopt when it is completely free, coinciding with the maximum radius it may reach.
On the other hand, the morphological descriptors md and ma (and also mc if this descriptor is calculated) can include any of: the minimum radius of the cross-section of the vasculature perpendicular to the central line, the maximum radius, the radius of the equivalent circumference with the perimeter equal to the cross-section perpendicular to the central line, the radius of the equivalent circumference with an area equal to the cross-section perpendicular to the central line, etc., or combinations of the foregoing.
If the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method further comprises (step 303) making the point Pa equal to a point next to Pa in the proximal direction along the traced central line, calculating (step 304) a local morphological descriptor ma of a cross-section of the vascular structure at said point Pa, and calculating (step 305) ha=Mn·dumping (ma), where ha refers to a distance, and dumping(m) is a mathematical function in the interval [0,1] that accounts for the variation of ha when the interlaced device 1 has different expansion diameters (or simply expansions).
The relation of the device expansion and the height of the distal section 101S having the singularity is nonlinear. Thus, the damping function accounts for this nonlinearity by “damping” (i.e. multiplying by a number between 0 and 1) the nominal morphological descriptor Mn to obtain the height ha. In the case of a linear relation between the device expansion and its height, the damping will be constant for different values of ma. It might also be equal to 1, depending on the design and behavior of the interlaced device 1. Consequently, the expansion diameter (or simply expansion) is the diameter achieved by the interlaced device 1 and can go from 0 (the interlaced device 1 is fully closed, e.g. inside the catheter) to the nominal diameter (i.e. the diameter of the interlaced device 1 when is fully opened, with the maximum diameter). In this particular embodiment, the expansion diameter is governed by ma. The larger the vessel is the larger ma and the larger expansion will be, but not being larger than the nominal diameter.
In step 306, the method comprises identifying a point Pam that is located an interval ha from the distal point Pd and on a plane perpendicularly intersecting the traced central line at point Pa.
In step 307, a distance dd between the point Pa and point Pam is calculated, and the calculated distance dd is compared (step 308) with the local morphological descriptor ma. If dd is smaller (step 310) than the local morphological descriptor ma, steps 303-309 are repeated. Otherwise, (step 311) Pp=Pa is defined as the proximal point that limits a portion of the central line over the traced central line that will be needed for deploying the distal section 101S of the interlaced device 1.
It should be noted that the point Pa refers to the current point being studied at a given iteration of the algorithm, as a candidate to release the distal section 101S. The point Pa is iteratively searched, along the traced central line, advancing one small step at a time in the proximal direction. Because Pa candidates are predefined in some embodiments it can happen that a point Pa satisfying dd=ma might not exist. So, associated Pam to Pa should be such that the dd=>ha in the iterative search.
If the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn, the method comprises (step 302) selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is the minimum height, in the direction of the traced central line, achieved by said distal section 101S of the interlaced device 1, corresponding to the height of the section 101S being in the configuration corresponding to the nominal morphological descriptor Mn.
In step 402, a point Pa is defined as Pa=Pd. Then, in step 403, the method comprises identifying a point Pdm that is located an interval md from the distal point Pd and on a plane perpendicularly intersecting the traced central line at the distal point Pd.
In step 404, the method comprises comparing the morphological descriptor md with a nominal morphological descriptor Mn.
If the morphological descriptor md is smaller than the nominal morphological descriptor Mn, the method comprises making (step 406) the point Pa equal to a point next to Pa in the proximal direction along the traced central line, calculating (step 407) a distance da between point Pa and point Pdm, and comparing (step 408) the calculated distance da with the distance hd.
If the distance da is smaller than the distance hd (step 409), the preceding steps 406-408 are repeated (step 410). Otherwise, in step 411, Pp=Pa is defined as the proximal point that limits a portion of the central line over the traced central line that will be needed for deploying the proximal section 103S of the interlaced device 1.
As outlined for the section with a singularity at the distal end 101, it should be noted that the point Pa refers to the current point being studied at a given iteration of the algorithm, as a candidate to release the distal section 101S. The point Pa is iteratively searched, along the traced central line, advancing one small step at a time in the proximal direction. Because Pa candidates are predefined in some embodiments it can happen that the point Pa satisfying that da=hd might not exist. So, associated Pdm to Pa should be such that da=>hd in the iterative search.
If the morphological descriptor md is greater than or equal to the nominal morphological descriptor Mn (step 404), the method comprises selecting the proximal point Pp as the point that is located a distance dmin from the distal point Pd in the proximal direction, where dmin is the minimum height, over the traced central line, achieved by the proximal section 103S, corresponding to the height of said section 103S being in the configuration corresponding to the morphological descriptor md.
In the event that the interlaced device is identical to the device of
If the new nominal height is greater than 0, steps 503 to 505 are repeated for the segment contiguous to the preceding segment, moving forward in the proximal direction. If the new nominal height is approximately 0 (smaller than the separation between points of the traced central line), the lengths of all the segments in respect of which it moved forward are added together, this sum being the final height of the interlaced device 1 after its positioning.
In step 702, the method comprises dividing the surface of the singularity into concentric circumferences 82, wherein the circumferences have a common center at the distal point Pd, and subsequently dividing (step 703) the surface into a plurality of cells 83. Each cell is obtained particularly considering the section of one of said portions 81 contained between two consecutive concentric circumferences 82.
Continuing with the methodology of
A
c=∫θ
For the partition performed, the variation dθ of the angle is constant Δθ, then:
A
c=½(r12−r02)Δθ
In general for the cell i, i.e., for the circumference of radius ri=dr
A
c=½(ri2−ri-12)Δθ
where ri-1 is the radius of the circumference taken in step i−1 and constituting the lower section of the current cell. In one embodiment, in each concentric circumference 82 the total number of cells 83 is Nh and the area is the same in all of them. The area of the uncovered surface of the cell 83 depends on the angle α formed by the thread enclosed in cell 83 with the radial direction.
A
uncovered
=A
c
−A
h
where Ac is the total area of the cell 83 and Ah is the area of the thread inside the cell 83.
The area of the uncovered surface consists of two “triangles” the surfaces of which depend on angles αi and αi-1 (see
Finally, in step 705, the porosity of each cell 83 is calculated as the ratio between the uncovered area divided by the total area of the cell 83 or the ratio between the covered area divided by the total area of the cell 83.
The proposed invention can be implemented in hardware, software, firmware, or any combination thereof. If it is implemented in software, the functions can be stored in or encoded as one or more code instructions in a computer-readable medium.
The scope of the present invention is defined in the attached claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20382143.4 | Feb 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/077935 | 10/6/2020 | WO |