Personalized coronary stents

The present invention relates to medical technology, and more particularly to interventional cardiology.

Cardiovascular disease is one of the greatest health problems in developed countries. One of the more serious conditions is coronary artery disease (CAD), in which a portion of the smooth, elastic lining inside the coronary arteries is usually damaged by calcium deposits, fatty deposits, and abnormal inflammation. The cells harden, harden, and swell, leading to the formation of plaque and what is called atherosclerosis. This plaque creates an obstruction to the normal supply of oxygenated blood to the heart muscle (known as a stenosis), which can cause chest pain (angina pectoris) and ultimately cardiac arrest. may lead to

The field of interventional cardiology is the branch of cardiology that specializes in catheter-based treatment of structural heart disease, such as CAD. One interventional cardiology procedure is known as percutaneous coronary intervention (PCI). In one mode of PCI, a catheter is inserted into a major systemic artery, either in the groin or arm, and steered toward the ostium of the coronary branch at the origin of the aorta. This catheter takes the form of a thin tube (known as a Judkins catheter) through which a radiopaque dye can be delivered into the bloodstream, allowing a special type of X-ray called fluoroscopy. to allow visualization of the coronary arteries (known as an angiogram). Other techniques for imaging the coronary arteries (eg, intravascular ultrasound) can also be used. If the narrowing (stenosis) is deemed severe enough, a common treatment is to insert a stent to restore the artery to its original (non-stenotic) diameter. To deploy the stent, another catheter is threaded through the first catheter and then advanced further to where the coronary artery is narrowed. Once the tip is in place, the balloon around which the stent is crimped is inflated. The tip of the balloon compresses the plaque and expands the stent. Once the plaque is compressed and the stent is in place, the balloon is deflated and withdrawn. The stent remains in the artery, holding it open.

Although PCI generally provides beneficial patient outcomes, long-term complications such as in-stent restenosis (ISR) or stent thrombosis (ST) can exist. ISR occurs when tissue and plaque grow through the stent wall. ST occurs when a clot adheres to the stent. Either complication re-interrupts the normal blood flow that the stent was supposed to restore.

Advances in stent material selection have led to the current generation of stents being drug-eluting stents (coated with a drug that is slowly released to prevent cell proliferation and reduce ISR and ST). ), as well as bioresorbable stents, which are designed to dissolve into the bloodstream over an extended period of time, during which time the artery is given a chance to heal in a non-stenotic state. While material selection greatly affects patient outcome, another very important characteristic is how well the stent fits in the patient's artery. Ideally, the stent, when expanded, contacts the arterial wall in an "apposed" state that does not push against the wall to the point of damaging the endothelium (the layer of cells that forms the inner lining of the arterial wall). should remain. In this case the endothelium should form a thin layer that grows over the stent as the artery heals, but not to the point where ISR or ST occurs.

Stents are currently manufactured in a variety of lengths and diameters, and the appropriate size is selected by examining the stenosed artery using imaging techniques such as an angiogram. One problem with this approach is that the artery may be tapered or have some complex shape, and for that artery a simple cylindrical structure would not fit into the artery wall in apposition. may not be suitable for maintaining contact between Therefore, the difference between the off-the-shelf stent shape and the patient-specific shape can be substantial, resulting in complications due to malapposition and inappropriate size. These differences are tens of microns to hundreds of microns, but the technology currently employed does not allow for more precise control of the tolerances. The lack of contact between the stent and the arterial wall (maladaptation) can result in complex patterns of low wall shear stress (friction caused by blood flow to the arterial wall), which can lead to ISR and ST. Proliferation is brought about.

Accordingly, there is a need for techniques that address the problems discussed above.

<p><patcit num="1"><text>U.S. Patent Application No. 15/498,159</text></patcit><patcit num="2"><text>U.S. Patent Application No. 15/498,185</text></patcit></p>

<p>The principles of the present invention provide techniques for producing individualized coronary stents.</p>

<p>Viewed from a first aspect, the present invention is a method of providing a stent, comprising the steps of generating a 3D model of a non-stenotic shape of a vessel in response to a three-dimensional (3D) model of the actual shape of the vessel. and establishing a parametric description of a stent that can be expanded from a collapsed configuration to a final configuration apposed to a non-stenotic configuration, the parametric description characterizing the struts of the stent. Varying the parameters of the parametric description in response to a design heuristic that includes establishing and risking stent strut failure during plastic deformation between the collapsed configuration and the final configuration. A method is provided that includes creating a design for a stent by cutting, and shaping a stent according to the design for the stent.</p><p>Viewed from a further aspect, the present invention is an apparatus comprising a mandrel having a generally cylindrical hollow membrane for receiving a balloon and having a plurality of posts projecting from the outer surface of the membrane, the mandrel comprising: A mandrel, at least one of which protrudes to a different radius than at least one of the other posts, and a stent supported on the mandrel with the posts of the mandrel abutting the bridges of the stent. Provide equipment.</p><p>Viewed from a further aspect, the present invention is a method of providing a stent comprising: inserting a stent having an asymmetric collapsed configuration into a blood vessel; and expanding the stent from a collapsed configuration to an asymmetric final configuration corresponding to the asymmetric non-stenotic shape of a given location within the vessel. offer.</p><p>Viewed from a further aspect, the invention is a computer program product for providing a stent and a computer readable storage medium readable by a processing circuit to implement a method for performing the steps of the invention. A computer program product is provided that includes a computer readable storage medium storing instructions to be executed by a processing circuit to perform the processing.</p><p>Viewed from a further aspect, the invention is a computer program stored on a computer readable medium and loadable into the internal memory of a digital computer, said program performing the steps of the invention when run on the computer. provides a computer program comprising software code portions for performing</p><p>In one aspect, an exemplary method includes generating a 3D model of a non-stenotic shape of the vessel in response to a 3D model of the actual shape of the vessel. The method comprises establishing a parametric description of a stent expanded from a collapsed configuration to a final configuration apposed to a non-constricted shape, the parametric description including parameters characterizing struts of the stent. further includes The method produces a design for the stent by varying the parameters of the parametric description in response to a heuristic design that included the risk of stent strut failure during plastic deformation between a collapsed configuration and a final configuration. further including Additionally, the method includes configuring the stent according to the design for the stent.</p><p>In accordance with another aspect of the invention, an exemplary apparatus is a mandrel having a generally cylindrical hollow membrane for receiving a balloon and having a plurality of posts projecting from an outer surface of the membrane, comprising: a mandrel in which at least one of the posts protrudes to a different radius than at least one other of the posts; and a stent supported on the mandrel by the posts of the mandrel abutting the bridges of the stent. include.</p><p>According to another aspect of the invention, an exemplary method includes inserting a stent having an asymmetric collapsed configuration into a blood vessel and moving through the blood vessel to reach a stenosis at a given location in the blood vessel. and expanding the stent from a collapsed configuration to an asymmetric final configuration corresponding to the asymmetric, non-stenotic shape of the given location within the vessel.</p><p>In accordance with another aspect of the invention, a non-transitory computer-readable medium causes a computer, when executed by a computer, to facilitate any of the exemplary methods discussed above. embody computer-executable instructions; In one or more embodiments, the computer-executable instructions include instructions for controlling a 3D printer to materialize the stent. In accordance with another aspect of the invention, an apparatus includes a memory embodying computer-executable instructions and, coupled to the memory, computer-executable instructions to facilitate any of the exemplary methods discussed above. and at least one processor operated by</p><p>As used herein, "facilitate" an action includes performing the action, facilitating the action, assisting the action to be performed, or causing the action to be performed. . Thus, by way of example, and not limitation, an instruction executing on one processor may, by sending appropriate data or commands to cause it to perform its action, or to assist its performance, to It can facilitate actions performed by instructions executing on a remote processor. For the avoidance of doubt, if an action is facilitated by an actor other than by performing that action, that action is still performed by some entity or combination of entities.</p><p>One or more embodiments of the invention or elements thereof may be implemented in the form of a computer program product comprising a computer readable storage medium together with computer usable program code for performing the method steps indicated. can. Further, one or more embodiments of the invention or elements thereof are directed to a system (or apparatus) including a memory and at least one processor coupled to the memory and operable to perform the exemplary method steps. can be implemented in the form In yet another aspect, one or more embodiments of the invention or elements thereof can be embodied in a means for performing one or more of the method steps described herein. , means are (i) a hardware module, (ii) a software module stored on a computer readable storage medium (or multiple such media) and implemented on a hardware processor, or (iii) A combination of (i) and (ii) may be included, any of (i)-(iii) implementing the particular technique described herein.</p><p>These and other features and advantages of the present invention will become apparent from the following detailed description of exemplary embodiments thereof, which shall be read in conjunction with the accompanying drawings.</p><p>Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings.</p>

<figref num="1">FIG. 10 illustrates generating a desired (non-stenotic) vessel shape from a 3D model of a stenosed vessel, according to an exemplary embodiment of the present invention;</figref><figref num="2">FIG. 10 illustrates the creation of a personalized coronary stent design from a stent template and desired vessel geometry, according to an exemplary embodiment of the present invention;</figref><figref num="3">FIG. 10 shows a parametric design for a generic stent template, according to an exemplary embodiment of the invention;</figref><figref num="4">4 is a flowchart of a method of creating a final configuration of a personalized coronary stent, according to an exemplary embodiment of the invention;</figref><figref num="5">FIG. 10 illustrates the creation of a mandrel shape from a mandrel template and individualized coronary stent design, in accordance with an exemplary embodiment of the present invention;</figref><figref num="6">FIG. 3 is a side cross-sectional view of a personalized coronary stent supported on a mandrel within a blood vessel, in accordance with an exemplary embodiment of the present invention;</figref><figref num="7">7 is an end cross-sectional view of the individualized coronary stent, mandrel, and vessel of FIG. 6, in accordance with an exemplary embodiment of the present invention; FIG.</figref><figref num="8">FIG. 8 is an end cross-sectional view of the individualized coronary stent and mandrel of FIGS. 6 and 7 in a crimped configuration, according to an exemplary embodiment of the invention;</figref><figref num="9">4 is a flowchart of a method for deploying a personalized coronary stent, according to an exemplary embodiment of the invention;</figref><figref num="10">1 illustrates a computer system that may be useful in implementing one or more aspects and/or elements of the present invention and represents a cloud computing node according to an embodiment of the present invention; FIG.</figref>

Based on angiograms and other imaging techniques, it is possible to construct detailed three-dimensional (3D) models of stenosed vessels. For example, standard intravascular imaging catheters use optical coherence tomography, which provides high resolution images by radially illuminating the laser. Equipping the imaging catheter with an inertial measurement unit (IMU) allows position information to be obtained. Using this positional information, a 3D model of the interior of the vessel (ie, the interior of the stenosed vessel) can be created from the images.

According to one or more exemplary embodiments, a time-varying 3D model is generated using a camera-equipped catheter that also carries radiopaque position markers. For example, radiopaque position markers may include a pair of elliptical hoops attached to the catheter so that they remain stationary relative to the camera. The hoops are arranged orthogonally to each other, and because each hoop is entirely radiopaque, the complete ellipse can be seen from all angles on the angiogram, with the exception of one of the ellipses. It cannot be viewed from an angle parallel to the plane of one ellipse, in which case one line is visible on the angiogram. A catheter with a camera is introduced over a guidewire into the patient's vasculature, and while the catheter is guided through the vasculature to a target location, camera images are captured from the catheter and a 3D model is generated for this target location. . In addition to camera images from the catheter, angiographic images of the catheter and guidewire are also captured to define a time-varying reference curve, and catheter accelerometer and gyroscope data are recorded. By integrating the accelerometer and gyroscope data in combination with camera and angiographic images over time, a time-varying 3D model (4D model) of the catheter and target location is created. No. 15/498,159, filed April 26, 2017, entitled "Intravascular Catheter for Modeling Blood Vessels," and U.S. patent application Ser. The entire disclosure of "Intravascular Catheter Including Markers" is incorporated by reference.

In particular, these previously filed patent applications are a method of generating a four-dimensional model by capturing images of a catheter and vessel as the catheter is guided through the vessel to a target location. , the catheter is disposed on a guidewire; constructing a time-varying three-dimensional reference curve that describes the trajectory of the guidewire; and constructing a time-varying three-dimensional model of . Advantageously, these earlier-filed patent applications further demonstrate that constructing a time-varying three-dimensional reference curve describing the trajectory of the guidewire also allows the guidewire to be viewed over a complete cardiac cycle. , and at least two angiographic runs from different viewing angles for the proximal marker, the distal tip marker, and the lens marker; mapping to positions within a cycle; selecting a subset of frames of at least two angiography runs that include at least that cardiac cycle; segmenting the guidewire from that subset of frames; calculating over time in the system to determine the reference curve as the trajectory of the lens marker in the world coordinate system as a function of time.

Preferably, these earlier-filed patent applications describe a method wherein constructing a time-varying three-dimensional model of an artery using a reference curve further comprises measuring linear and rotational accelerations of the catheter. While recording, perform intravascular imaging pullback at a known speed and at least one angiographic run from the viewing angle used in determining the guidewire trajectory. acquiring during pullback of intraimaging; mapping each frame of at least one angiographic run to a position within the cardiac cycle; and segmenting the lens marker of the catheter in each of the frames. , calculating the distance of the lens marker along the trajectory of the guidewire to the starting position in multiple steps of the intravascular imaging pullback using the known speed of the intravascular imaging pullback; Transforming the orientation of the catheter lens markers in each of the frames to the world coordinate system, and using the world coordinate positions of the lens markers to translate the linear and rotational accelerations of the catheter forward along with the trajectory of the guidewire. By integrating over time, obtaining multiple cross-sectional curves for each frame, mapping each cross-sectional curve to a corresponding point along the trajectory of the guidewire, and connecting the cross-sectional curves, the time obtaining a dynamically varying 3D surface model.

In addition, these previously filed patent applications are methods for generating a four-dimensional (4D) model during a percutaneous coronary intervention (PCI) procedure, wherein the catheter is guided through a vessel to a target location. and capturing an image of a catheter and a blood vessel, wherein the catheter is disposed on a guidewire and comprises a plurality of markers and a monitoring body, wherein the images are captured from at least two different viewpoints. , the guidewire and at least one marker are segmented from the image, and the segmented guidewire and at least one segmented marker are backprojected into three-dimensional (3D) space to define the movement of the monitoring body temporally. recording accelerometer and gyroscope data of the catheter using a combination of sensors as the catheter is pulled away from the location of interest; accelerometer and gyroscope data , predicting the linear and rotational positions of the surveillance body in the image, and using the predicted linear and rotational positions of the surveillance body to construct a 4D model of the surveillance body and vessels. and constructing a 4D model that includes a time-varying surface representing a blood vessel.

Preferably, these previously filed patent applications further disclose a method wherein capturing the images comprises capturing a plurality of angiograms. Preferably, these previously filed patent applications further disclose a method wherein capturing the images includes simultaneously capturing different viewpoints over a single cardiac cycle. Preferably, these previously filed patent applications further disclose a method wherein capturing the images comprises capturing different viewpoints one at a time over successive cardiac cycles. there is Preferably, these earlier filed patent applications further disclose a method wherein the time-varying reference curve defines the movement of the monitoring body as a series of coordinates in space-time. Preferably, these earlier-filed patent applications further disclose methods wherein the accelerometer and gyroscope data include measurements of inertial acceleration and rotational position in three dimensions. Preferably, these earlier filed patent applications further disclose a method further comprising correcting drift error accumulated in accelerometer data using magnetometer data.

However, the exact mode of obtaining the time-varying 3D model may differ, for example the time-varying 3D model may be obtained by MRI or ultrasound. Therefore, it is presumed that a time-varying 3D model is obtained by any method, the model is used to identify the stenosis, and the model is smoothed over the stenotic region to create a non-stenotic shape. be.

As shown in FIG. 1, according to an exemplary embodiment of the present invention, a computer generates a , implements the method 300 to generate a 3D model of the non-stenotic shape 302 of the vessel. In one or more embodiments, the computer averages the time-varying 3D model of the stenotic shape 304 to identify the stenosis 306 and smoothes the vessel wall 308 across the stenosis 306 to obtain the non-stenotic shape. Generate 302.

FIG. 2 illustrates in block diagram form a method 400 for creating a final configuration of an individualized coronary stent 402 based on a generic stent template 403 and a 3D model of a non-stenotic shape 302. As shown in FIG. The individualized coronary stent 402 according to embodiments of the present invention is well-apposed to the non-stenotic shape 302, thereby alleviating the problems associated with using off-the-shelf stents.

To provide an automated method of generating the final configuration of individualized coronary stent 402, a parametric description of the stent is required. A parameter description defines some key geometry parameters that can be tuned into an optimization routine with a continuum mechanics solver.

FIG. 3 depicts a detail 500 of the generic stent template 403 in which two adjacent arches 502, 504 of the generic stent template 403 are shown. Each arch 502, 504 includes a pair of struts 506 that are joined together at strut intersections (arch vertices 508). The two arch vertices 508 are connected by a bridge 510 . Parameters of this particular design include the length (designated a) and thickness (designated b) of bridge 510, and the thickness (designated c) and length (designated d) of each strut 506. included. As part of determining the final configuration for the patient, the software sets the parameters of the template to ensure that the final configuration of stent 402 is juxtaposed to non-stenotic shape 302 and is less likely to fail during an expansion event. fix it.

Referring again to FIG. 2, once the non-stenotic shape 302 has been generated, the computer uses heuristic design to adjust the key shape parameters of the generic stent template 403 to create the final individualized coronary stent 402 . Implement a method 400 for determining configuration. At 404 , the computer generates candidate configurations 406 by relaxing the vertices 508 of the generic stent template 403 so that they are juxtaposed to the 3D model of the non-stenotic shape 302 . The computer implements relaxation by imposing a radial inertial force 412 on the generic stent template 403 so that the vertices 508 are evenly distributed in the non-stenotic vessel shape 302 . Next, the computer implements the method 600 (shown in FIG. 4) of validating the candidate configuration 406 for the placement procedure.

FIG. 4 flowcharts a method 600 of validating a candidate configuration 406 for a placement procedure. In one or more embodiments, the computer checks the validity of candidate configurations by heuristic design. In one or more embodiments, validating candidate configuration 406 includes, at 602, plastic deformation of the stent from candidate configuration 406 to collapsed configuration 416 (crimping the stent for insertion into a vessel). ) using the continuum mechanics solver described above. In one or more embodiments, validating the candidate configuration includes, at 604, plastic deformation of the stent from the collapsed configuration 416 back to the candidate configuration 406 (expanding the stent for placement in the vessel). ) to facilitate mechanical stress/strain analysis. At 605 the computer applies heuristic design to the results of the mechanical stress/strain analysis 602,604. A heuristic design is, for example, no failure of the stent after plastic deformation. If the heuristic design is not satisfied, i.e., if the computer identifies any failure during plastic deformation, at 606, the computer performs a , parameters a, b, c, d to generate a modified stent template 418 having different stent strut thicknesses (variable stiffness). At 608 , the computer generates new candidate configurations 420 based on the modified stent template 418 and the non-stenotic shape 302 .

In one or more embodiments, collapsed configuration 416 conforms to modified stent template 418 . In other embodiments, collapsed configuration 416 is a version of candidate configuration 406 that has been plastically deformed (crimped) to fit within the same radius as modified stent template 418, see FIG. Further description is provided below with reference.

The computer repeats blocks 602, 604, 606, 608 until candidate configuration 406 satisfies the heuristic design (e.g., no corruption), and in response the computer, at 610, It facilitates saving the candidate configuration 406 as the final configuration of the stent 402 .

The method 400 thus produces a design for the 3D individualized coronary stent 402 by varying the parameters of the parametric description of the generic stent "template" design 403, where the parametric description defines the parameters characterizing the struts of the stent template. include. More specifically, the method 400 allows the shape of the deformed template to conform to the contours of complex artery shapes 302, including features such as tapers, ridges, and other non-axisymmetric features. , including modifying the length and thickness of struts 506 and bridges 510 . To modify the stent template 403, the shape is a simple geometry where the center of mass of the vertex 508 defines a coordinate set in 3D space and the linear segment defined by the two coordinates defines a simplified strut or bridge. are regarded as structured structures. The points corresponding to vertices 508 are then repeatedly moved around to match the complexity of artery shape 302 while maintaining the topological connectivity of struts 506 and bridges 510 . The manner in which the deformation process is performed is such that the points defining the vertices 508 of the stent struts 506 are repeated radially inward or outward (depending on whether the starting point is inside or outside the target shape surface 302). It is moved and continued until all vertices 508 are within a user-specified distance (apposition tolerance) from the surface. The direction to move the point can be calculated from either the centerline of the stent template 403, the centerline of the target shape 302, or using other techniques common in computational geometry. be able to. As described above with reference to FIG. 4, in response to heuristic designs that represent or include the risk of stent strut failure during plastic deformation between the collapsed configuration and the final configuration of stent 402, Changing parameters of the template is repeated.

FIG. 5 shows a flowchart of a method 700 for establishing the shape of mandrel 702 to support stent 402 in a collapsed configuration. Mandrel 702 is created from mandrel template 704 and the final configuration of individualized coronary stent 402 . Mandrel template 704 has a generally cylindrical body formed as a relatively thin membrane 705 over most of its length. Mandrel template 704 also includes a plurality of relatively rigid posts 706 projecting from its membrane 705 and relatively rigid guide sections 707 connected to the ends of its membrane 705 . In one or more embodiments, post 706 and guide section 707 may be thicker in cross-section than membrane 705 to provide relatively higher stiffness. Guiding section 707 includes radiopaque markers 708, eg, elliptical markers similar to those described above with respect to camera catheters. This marker 708 is positioned to provide a unique indication of the mandrel's position and orientation within the angiogram.

Mandrel 702 has a relaxed shape and an elongated shape. In the relaxed configuration, the hollow membrane 705 is relaxed and fits over a standard balloon catheter in its uninflated state. In the stretched configuration, hollow membrane 705 stretches over a standard balloon catheter in its inflated state. Membrane 705 is a relatively flexible membrane, while post 706 is a relatively rigid member attached to membrane 705 at its base. Mandrel 702 has a plurality of posts 706 each extending to a radius determined as follows. First, at 710, a model 711 of the concentric, coaxial configuration of mandrel 702 and individualized coronary stent 402 is established. Then, at 712, the radial distance 713 from the elongated shape of the mandrel 702 to each bridge 510 in the final configuration of the individualized coronary stent 402 is calculated. Radial distance 713 gives the height of post 706 . Thus, to expand the individualized coronary stent 402 from its collapsed configuration 416 to its final configuration, given the uniform radial displacement of the mandrel membrane 705 achieved by inflating a standard balloon catheter, The position and size of post 706 are selected.

FIG. 6 shows in cross-sectional side view the final construction of individualized coronary stent 402 supported by its bridges 510 on posts 706 of mandrel 702 within vessel wall 308, according to an exemplary embodiment of the invention. . Balloon catheter 802 is shown inflated within mandrel 702 to hold the mandrel in its extended shape. Once the balloon catheter 802 was allowed to deflate, the mandrel elastically returned to its relaxed shape while the individualized coronary stent 402 was plastically deformed to its final configuration, apposed to the vessel wall 308. remain in the state.

FIG. 7 shows individualized coronary stent 402, mandrel 702, balloon catheter 802, and vessel wall 308 in cross-sectional end view.

In one or more embodiments, individualized coronary stent 402 is 3D printed in its expanded state (final configuration) so that it can be slid over balloon catheter 802 and mandrel 702, and then attached to them. It is plastically crimped and then deployed. Alternatively, individualized coronary stent 402 is 3D printed around post 706 of mandrel 702 and then crimped to post 706 . Primarily for this reason, the stent design process includes stress/strain analysis of deformation from the final configuration to the collapsed configuration and from the collapsed configuration back to the final configuration.

A standard crimping device for a coronary stent would apply a uniform radial inward displacement, which would not be suitable for the asymmetrical shape of the individualized coronary stent 402 . Accordingly, referring to FIG. 8, sleeve 1002 is designed and embodied (eg, 3D printed) along with individualized coronary stent 402 . This sleeve 1002 allows the use of standard crimping devices to crimp the stent. The sleeve 1002 has a body 1004 that is essentially the same and therefore symmetrical as the generic stent template, but with a diameter slightly larger than the maximum diameter in the final configuration of the individualized coronary stent. Sleeve 1002 includes inwardly projecting fingers 1006, which are a mass of the same 3D printable material (eg, polylactic acid) as the rest of sleeve 1002 and the stent. Fingers 1006 are printed on bridges 1010 of sleeve 1002 and aligned with bridges 510 of the stent (in registry). with) because the bridges do not undergo any circumferential displacement during the crimping or expansion process. The length of fingers 1006 is defined by calculating the distance between support sleeve 1002 and the corresponding contact points (bridges 510) of the stent. FIG. 8 thus shows in cross-sectional end view the collapsed configuration 416 of the individualized coronary stent crimped to the post 706 of the mandrel 702 by the sleeve 1002 .

FIG. 9 shows a method 1100 of constructing and deploying the individualized coronary stent 402, mandrel 702, and sleeve 1002. FIG. According to one or more implementations of method 1100, computing system 10 facilitates implementing individualized coronary stent 402 in its final configuration. In one or more embodiments, computing system 10 controls 3D printer 1103 to facilitate materializing individualized coronary stent 402 . Thus, in one or more embodiments, at 1102 the computer controls the 3D printer 1103 to 3D print the mandrel membrane 705 , the post 706 and the guide section 707 . 3D printing of the mandrel 702 uses a very flexible but elastic material (eg, stretchable UV curable elastomer). At 1104 the computer then controls the 3D printer 1103 to 3D print the individualized coronary stent 402 . In one or more embodiments, the individualized coronary stent 402 is printed around the posts 706 of the mandrel such that the bridges 510 of the stent 402 are aligned with the posts. Depending on the reference view of the X-ray system that will be used during placement, the elliptical marker 708 is selected to have a particular view, which indicates that the individualized coronary stent 402 and post 706 are aligned with the marker. It affects the angular position printed on the mandrel film 705 . Alternatively, in one or more embodiments, individualized coronary stent 402 is printed separately from mandrel 702 and then assembled to the mandrel. A plastically deformable material (eg, polylactic acid) is used to 3D print the stent 402 .

At 1106 the computer controls the 3D printer 1103 to print the sleeve 1002 and its fingers 1006 . In one or more embodiments, sleeve 1002 is printed around individualized coronary stent 402 such that fingers 1006 are aligned with the bridges of stent 402 . Alternatively, in one or more embodiments, sleeve 1002 is printed separately from stent 402 and then assembled to the stent. A plastically deformable material (eg, polylactic acid) is used to 3D print the sleeve 1002 .

At 1108 , individualized coronary stent 402 , mandrel 702 and sleeve 1002 are mounted around balloon catheter 802 . At 1110 the assembly is crimped to the balloon catheter 802 . At 1111 the sleeve 1002 is removed, for example by cutting it. Then at 1112, the crimped assembly of balloon catheter 802, mandrel 702 and individualized coronary stent 402 is inserted into the blood vessel. At 1114, the assembly is guided to its deployment site using continuous or periodic angiograms to confirm the position and orientation of the assembly within the vessel. At 1116 , balloon catheter 802 is inflated to plastically deform individualized coronary stent 402 to appose vessel wall 308 . At 1118, the balloon catheter 802 is deflated to retract the catheter and elastic mandrel 702 through the vessel and out of the insertion site.

A time-varying model of the vessel can be used to aid in stent placement. When a stent is placed in an artery, one can imagine it moving around due to the motion of the heart and thus the coronary arteries. Therefore, the ellipses on the mandrel will also move around and change their appearance in the angiograms acquired during stent placement. In one or more embodiments, snapshots of the time-varying model are used to generate a non-stenotic shape that, when the stent is successfully deployed, matches the corresponding point in the cardiac cycle. The mandrel column, as can be seen from the reference viewing angle (for the X-ray system) and the point of the cardiac cycle from which the snapshot was chosen, that the radiopaque ellipse appears in a particular shape in the angiographic frame. and stents can be printed on the mandrel template. Additionally, we can see how the ellipse changes appearance as the entire balloon, mandrel, and stent assembly is moved around during the cardiac cycle, which provides more information about how the assembly is currently positioned. Given.

The techniques of the present invention can provide significant beneficial technical effects. For example, one or more embodiments provide one or more of better apposing the stent to the lumen wall, developing and fabricating custom stent designs in the laboratory.

Given the previous discussion, broadly speaking, an exemplary method according to one aspect of the present invention is to generate a 3D model of a non-stenotic shape of a vessel in response to a 3D model of the actual shape of the vessel. is understood to include The method comprises establishing a parametric description of a stent expanded from a collapsed configuration to a final configuration apposed to a non-constricted shape, the parametric description including parameters characterizing struts of the stent. further includes The method produces a design for the stent by varying the parameters of the parametric description in response to a heuristic design that included the risk of stent strut failure during plastic deformation between a collapsed configuration and a final configuration. further including Additionally, the method includes configuring the stent according to the design for the stent.

In one or more embodiments, the method further comprises establishing a shape of the mandrel to support the stent in a collapsed configuration, and shaping the mandrel according to the shape of the mandrel. In one or more embodiments, establishing the shape of the mandrel is establishing a plurality of pillars protruding from the membrane of the mandrel, wherein at least one of the pillars extends from at least one of the pillars. Includes establishing, extending to a different radius than other posts. Further, in one or more embodiments, establishing the shape of the mandrel includes configuring posts of the mandrel to support bridges of the stent in a collapsed configuration. Also, in one or more embodiments, establishing the shape of the mandrel comprises configuring the posts of the mandrel to also support the bridges of the stent in its final configuration when the mandrel is expanded to its elongated shape. including. In one or more embodiments, materializing the mandrel includes 3D printing the mandrel and materializing the stent includes printing the mandrel such that the bridges of the stent are aligned with the posts of the mandrel. It involves 3D printing a stent around it.

In one or more embodiments, shaping the stent includes 3D printing the stent in a final configuration, and an exemplary method facilitates crimping the stent from the final configuration to a collapsed configuration. establishing a shape of the sleeve so as to do so; and embodying the sleeve according to the shape of the sleeve. In one or more embodiments, the shape of the sleeve includes a generally cylindrical body and a post projecting inwardly from the body. According to certain embodiments, establishing the shape of the sleeve includes configuring the posts of the sleeve to uniformly radially compress the bridges of the stent from its final configuration to its collapsed configuration. In one or more embodiments, embodying the sleeve includes 3D printing the sleeve around the stent.

In one or more embodiments, the exemplary method also includes establishing a shape of a mandrel to support a stent in a collapsed configuration; shaping the mandrel according to the shape of the mandrel; around a mandrel; establishing a shape of the sleeve to facilitate crimping the stent from its final configuration to a collapsed configuration; and shaping the sleeve according to that sleeve shape. placing a sleeve around the stent; and crimping the stent onto the mandrel using the sleeve to distribute a uniform radial force to the asymmetric bridges of the stent.

In accordance with another aspect of the invention, an exemplary apparatus is a mandrel having a generally cylindrical hollow membrane for receiving a balloon and having a plurality of posts projecting from an outer surface of the membrane, comprising: a mandrel wherein at least one of the posts protrudes to a different radius than at least one other of the posts; and a stent supported on the mandrel with posts of the mandrel abutting bridges of the stent. including.

In one or more embodiments, the device also includes a balloon catheter inserted within the mandrel. In one or more embodiments, the device also includes a sleeve surrounding the stent, the sleeve having inwardly projecting fingers opposite the fingers of the mandrel and contacting the bridges of the stent, and At least one of the inwardly projecting fingers projects to a different radius than at least one other of the inwardly projecting fingers.

In one or more embodiments, the balloon catheter is inserted into the mandrel.

In one or more embodiments, the mandrel includes elliptical radiopaque markers.

According to another aspect of the invention, an exemplary method includes inserting a stent having an asymmetric collapsed configuration into a blood vessel and moving the stent through the blood vessel to reach a stenosis at a given location in the blood vessel. and expanding the stent from a collapsed configuration to an asymmetric final configuration corresponding to the asymmetric, non-stenotic shape of the given location within the vessel. In one or more embodiments, the method also includes supporting the stent with a mandrel having asymmetrical posts to support the collapsed configuration of the stent at the bridges of the stent during insertion and manipulation of the stent. and expanding the stent includes inflating a balloon within the mandrel.

In accordance with another aspect of the invention, computer-executable instructions that, when executed by a computer, cause the computer to facilitate any of the exemplary methods discussed above are defined as non-transitory A computer readable medium embodies. In one or more embodiments, the computer-executable instructions include instructions for controlling a 3D printer to materialize the stent.

In accordance with another aspect of the invention, an apparatus includes a memory embodying computer-executable instructions and, coupled to the memory, computer-executable instructions to facilitate any of the exemplary methods discussed above. and at least one processor operated by

One or more embodiments of the invention or elements thereof may be implemented in the form of an apparatus including a memory and at least one processor coupled to the memory and operable to perform the exemplary method steps. can. FIG. 10 depicts a computing system 10 that may be useful for implementing one or more aspects or elements of the invention, or a combination thereof, according to an embodiment of the invention. An exemplary embodiment of a computing system 10 that is also shown. Referring now to Figure 10, computing system 10 is but one example of a suitable computer system and does not suggest any limitation as to the scope of use or functionality of the embodiments of the invention described herein. not a thing In any event, computing system 10 may implement and/or perform any of the functions described above.

In computing system 10 there are computer systems/servers 12 operating in conjunction with numerous other general purpose or special purpose computing system environments or configurations. Examples of well-known computing systems, environments, or configurations, or combinations thereof, that may be suitable for use with computer system/server 12 include personal computer systems, server computer systems, thin Clients, thick clients, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, set-top boxes, programmable consumer electronics, network PCs, minicomputer systems , mainframe computer systems, and distributed cloud computing environments including any of these systems or devices.

Computer system/server 12 may be described in the general context of computer system-executable instructions, such as program modules, being executed by the computer system. Generally, program modules may include routines, programs, objects, components, logic, data structures, etc. that perform particular tasks or implement particular abstract data types. Computer system/server 12 may also be practiced in distributed cloud computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed cloud computing environment, program modules may be located in both local and remote computer system storage media including memory storage devices.

As shown in FIG. 10, computer system/server 12 of computing system 10 is in the form of a general purpose computing device. The components of computer system/server 12 include one or more processors or processing units 16 , system memory 28 , and bus 18 coupling various system components including system memory 28 to processor 16 . may include, but are not limited to:

Bus 18 can be of several types, including memory buses or memory controllers, peripheral buses, accelerated graphics ports, and processor or local buses using any of a variety of bus architectures. Represents one or more structures of any of the bus structures. By way of example and not limitation, such architectures include the Industry Standard Architecture (ISA) bus, Micro Channel Architecture (MCA) bus, Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA) local bus, and Includes Peripheral Component Interconnect (PCI) bus.

Computer system/server 12 typically includes a variety of computer system readable media. Such media can be any available media that can be accessed by computer system/server 12 and includes both volatile and nonvolatile media, removable and non-removable media. .

The system memory 28 may include computer system readable media in the form of volatile memory such as random access memory (RAM) 30 and/or cache memory 32 . Computer system/server 12 may also include other removable/non-removable, volatile/non-volatile computer system storage media. By way of example only, storage system 34 may be provided for reading from and writing to non-removable, non-volatile magnetic media (not shown, but commonly referred to as "hard drives"). can be done. Magnetic disk drives (not shown) for reading from and writing to removable non-volatile magnetic disks (e.g., "floppy (R) disks"), CD-ROMs, and DVD-ROMs , or other optical media. In such instances, each may be connected to bus 18 by one or more data media interfaces. As further shown and described below, memory 28 may include at least one program product having a set of (eg, at least one of) program modules configured to implement the functionality of embodiments of the present invention. good.

By way of example and not limitation, a program/utility 40 having a set (at least one) of program modules 42 as well as an operating system, one or more application programs, other program modules, and program data may also be stored in memory 28. Each operating system, one or more application programs, other program modules, and program data, or some combination thereof, may include an implementation of a networked environment. Program modules 42 generally implement the functions and/or methods of the embodiments of the invention described herein.

The computer system/server 12 may include one or more external devices 14 such as a keyboard, pointing device, display 24, one or more devices that allow a user to interact with the computer system/server 12, or It may also communicate with any device that enables computer system/server 12 to communicate with one or more other computing devices (eg, network cards, modems, etc.), or combinations thereof. Such communication may occur via input/output (I/O) interface 22 . Additionally, computer system/server 12 may be connected via network adapter 20 to a network such as a local area network (LAN), general wide area network (WAN), or public network (eg, the Internet), or combinations thereof. It can communicate with one or more networks. As shown, network adapter 20 communicates with other components of computer system/server 12 via bus 18 . Although not shown, it should be understood that other hardware and/or software components may be used with computer system/server 12 . Examples include, but are not limited to, microcode, device drives, redundant processing units, external disk drive arrays, RAID systems, tape drives, data archival storage systems, and the like.

Accordingly, one or more embodiments may utilize software running on a general purpose computer or workstation. Referring to FIG. 10, such implementations may use, for example, processor 16, memory 28, and display 24, and input/output interface 22 to external devices 14, such as keyboards or pointing devices. The term "processor" as used herein is intended to include any processing device such as, for example, those containing a CPU (Central Processing Unit) and/or other forms of processing circuitry. Further, the term "processor" may refer to two or more individual processors. The term "memory" includes, for example, RAM (random access memory) 30, ROM (read only memory), fixed memory devices (e.g. hard drive 34), removable memory devices (e.g. diskettes), and memory associated with a processor or CPU, such as flash memory. Additionally, the phrase "input/output interface" as used herein refers to, for example, one or more mechanisms (e.g., a mouse) for entering data into a processing unit and the results associated with the processing unit. It is intended to envision an interface to one or more mechanisms (eg, printers) for provisioning. Processor 16 , memory 28 , and input/output interface 22 may be interconnected via bus 18 as part of data processing unit 12 , for example. A suitable interconnection, for example via bus 18, may be provided for a network interface 20, such as a network card, which may be provided for interfacing with a computer network, and for interfacing with any suitable medium. A media interface such as a diskette or CD-ROM drive can also be provided.

Thus, computer software containing instructions or code for implementing the methods of the invention described herein can be stored in one of the associated memory devices (eg, ROM, fixed or removable memory). or may be stored in multiples, loaded partially or wholly (eg, into RAM), and implemented by the CPU when ready for use. Such software may include, but is not limited to, firmware, resident software, microcode, and the like.

A data processing system suitable for storing and/or executing program code includes at least one memory element coupled directly to memory element 28 or indirectly thereto through system bus 18. Includes processor 16 . The memory elements are local memory used during the actual implementation of the program code, a mass storage device, and at least a portion of the A cache memory 32 may be included to provide temporary storage of program code.

Input/output or I/O devices (including but not limited to keyboards, displays, pointing devices, etc.) can be coupled to the system either directly or coupled to it through intervening I/O controllers. can do.

Network adapter 20 is a system component for enabling the data processing system to become coupled to other data processing systems, or to remote printers or storage devices, through intervening private or public networks. may also be coupled to Modems, cable modems, and Ethernet cards are just a few of the currently available types of network adapters.

As used herein, including in the claims, "server" includes a physical data processing system (eg, system 12 shown in FIG. 10) running a server program. It will be appreciated that such a physical server may or may not include a display and keyboard.

Any of the methods described herein can include the further step of providing the system with separate software modules embodied on a computer-readable storage medium, which modules are represented by, for example, block diagrams and/or described herein, and by way of example and not by way of limitation, the modules/blocks, or sub-modules/sub-blocks or Note that any one, some, or all of both. This method step can then be performed using separate software modules and/or sub-modules of the system described above running on one or more hardware processors such as 16 . Further, computer program products, including providing systems with separate software modules, adapted to be implemented to perform one or more of the method steps described herein It can include a computer readable storage medium having code.

Exemplary System and Article of Manufacture Details The present invention may be a system, method, or computer program product, or a combination thereof. A computer program product may include one or more computer-readable storage media having computer-readable program instructions for causing a processor to implement aspects of the present invention.

A computer-readable storage medium may be a tangible device capable of holding and storing instructions for use by an instruction-executing device. A computer-readable storage medium may be, for example, without limitation, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination thereof. A non-exhaustive list of more specific examples of computer readable storage media include portable computer diskettes, hard disks, random access memory (RAM), read only memory (ROM ), Erasable Programmable Read Only Memory (EPROM or Flash Memory), Static Random Access Memory (SRAM), Portable Compact Disc Read Only Memory (CD-ROM), Digital Mechanically encoded devices such as versatile discs (DVDs), memory sticks, floppy discs, punched cards or grooved structures on which instructions are recorded, and any suitable combination of these included. Computer-readable storage media, as used herein, include radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., light pulses through fiber optic cables); Also, it should not be construed as a transient signal per se, such as an electrical signal transmitted over a wire.

Computer readable program instructions described herein can be transferred from a computer readable storage medium to a respective computing/processing device or over a network, such as the Internet, a local area network, a wide area network, or a wireless network, or both. can be downloaded to an external computer or external storage device via a combination of A network may include copper transmission cables, optical transmission fibers, wireless transmissions, routers, firewalls, switches, gateway computers, or edge servers, or combinations thereof. A network adapter card or network interface in each computing/processing device receives computer-readable program instructions from the network for storage on a computer-readable storage medium within the respective computing/processing device. Transfer possible program instructions.

Computer readable program instructions for implementing the operations of the present invention include assembler instructions, Instruction Set Architecture (ISA) instructions, machine instructions, machine dependent instructions, micro code, firmware instructions, state setting data, configuration data or source written in any combination of one or more programming languages, including object-oriented programming languages such as Smalltalk, C++, and procedural programming languages such as the "C" programming language or similar programming languages; May be code or object code. The computer readable program instructions may be distributed entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer, Or it may all run on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or wide area network (WAN), or (e.g., the Internet May be connected to external computers (via the Internet using a service provider). In some embodiments, electronic circuits including, for example, programmable logic circuits, field programmable gate arrays (FPGAs), or programmable logic arrays (PLAs) are used to implement aspects of the invention. The computer readable program instructions may be executed by utilizing the state information of the computer readable program instructions to personalize the electronic circuitry.

Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations, or block diagrams, or combinations thereof, and combinations of blocks in the flowchart illustrations, or block diagrams, or combinations thereof, can be implemented by computer readable program instructions.

These computer readable program instructions are represented in one or more blocks of flowcharts or block diagrams or combinations thereof as the instructions to be executed via a processor of a computer or other programmable data processing apparatus. It may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine to produce means for implementing the functions/acts described therein. These computer-readable program instructions may also be used to implement the functions/acts that the computer-readable medium on which the instructions are stored implement aspects of the functions/acts illustrated in one or more blocks of the flowcharts, block diagrams, or combinations thereof. stored on a computer readable storage medium to include articles of manufacture containing instructions to direct a computer, programmable data processor, or other device, or combination thereof, to function in a particular manner; It may be possible.

Computer readable program instructions also refer to the functions illustrated in one or more blocks of flowcharts or block diagrams, or combinations thereof, that are executed by a computer, other programmable apparatus, or other device. A sequence on a computer, other programmable apparatus, or other device that is loaded into another programmable data processing apparatus, or other device, to produce a computer-implemented process to implement a / act. may be executed.

The flowcharts and block diagrams in the drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each block of a flowchart or block diagram may represent a module, segment, or portion of instructions, which contain one or more executable instructions for implementing a particular logic function. . In some alternative implementations, the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently or these blocks may possibly be executed in the reverse order depending on the functionality involved. . In addition, each block of the block diagrams and/or flowchart illustrations, and combinations of blocks in the block diagrams and/or flowchart illustrations, perform the specified functions or acts, or represent dedicated hardware and computer instructions. Note that it can also be implemented by a dedicated hardware-based system that implements a combination of

The description of various embodiments of the invention has been presented for purposes of illustration and is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope of the described embodiments. The terms used herein are used to best describe principles of the embodiments, practical applications, or improvements over technology found on the market, or to describe the embodiments disclosed herein. Chosen to make it understandable for traders.

300,400,600,700 way

302 Non-constricting shape

304 constricted shape

306 stricture

308 blood vessel wall

402 Personalized coronary stent

403 Generic stent template

406 Candidate configuration

416 deflated configuration

412 inertial force

418 Modified stent template

420 new candidate configuration

500 details

502,504 arches

506 strut

508 apex of the arch

510 bridge

702 mandrel

704 mandrel template

705 film

706 pillar

707 Guidance division

708 marker

802 balloon catheter

1002 sleeve

1006 fingers

1010 bridge