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Medtronic Inc
Original Assignee
Medtronic Inc
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Filing date
Publication date
Priority claimed from US18/083,283external-prioritypatent/US20230230684A1/en
Application filed by Medtronic IncfiledCriticalMedtronic Inc
Publication of EP4463091A1publicationCriticalpatent/EP4463091A1/de
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B17/00—Surgical instruments, devices or methods
A61B2017/00017—Electrical control of surgical instruments
A61B2017/00203—Electrical control of surgical instruments with speech control or speech recognition
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B17/00—Surgical instruments, devices or methods
A61B2017/00017—Electrical control of surgical instruments
A61B2017/00207—Electrical control of surgical instruments with hand gesture control or hand gesture recognition
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B17/00—Surgical instruments, devices or methods
A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
A61B2017/00238—Type of minimally invasive operation
A61B2017/00243—Type of minimally invasive operation cardiac
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A61B2034/101—Computer-aided simulation of surgical operations
A61B2034/102—Modelling of surgical devices, implants or prosthesis
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A61B2034/101—Computer-aided simulation of surgical operations
A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A61B2034/107—Visualisation of planned trajectories or target regions
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
A61M25/00—Catheters; Hollow probes
A61M25/0009—Making of catheters or other medical or surgical tubes
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
A61M25/00—Catheters; Hollow probes
A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
Definitions
the disclosuregenerally relates to medical devices and, in particular, selecting and designing catheter profiles based on a plurality of anatomy parameters that govern how well a user can deliver therapy (e.g., drug, device, biologic, etc.) to a target in a patient or animal.
therapye.g., drug, device, biologic, etc.
catheter designis incredibly slow and expensive due to the design-build- test-implant cycle that can require a lot of time and expense. Additionally, it may be more challenging for a catheter to reach a specific anatomic target when used on a broad population of patients (e.g., especially when used with pediatric patients). Further, predicting which catheter may be utilized for a particular patient may prove to be difficult due to the various existing characteristics of already developed catheters (e.g., having varying shapes and stiffness distributions) such that a user may rely on their own preference of catheter over which catheter may best suit the anatomy of the patient.
the techniques of the present disclosuregenerally relate to a tool that can be used to select and/or design one or more catheter profiles for a particular individual or group of individuals.
catheter profilesmay be designed to quickly serve a patient population of interest by incorporating realistic anatomic measurements, enforcing heuristics for a particular catheter design (e.g., stiff sections for a first length, compliant sections for a second length, etc.), and providing data regarding successful catheter paths within an anatomy.
the utility of an existing catheter designmay be estimated in a new population based on provided anatomic data from that population.
an existing catheter profilemay be selected for a particular patient or patient population using, for example, preoperative imaging or anatomic correlation with a specific demographic (e.g., patient height, body mass index (BMI), weight, ethnicity, gender, disease state, etc.).
a specific demographice.g., patient height, body mass index (BMI), weight, ethnicity, gender, disease state, etc.
the toolmay operate in a variety of different ways to select or design one or more optimal catheter profiles for a patient or group of patients. For example, the tool may gather a data set including, e.g., anatomy/catheter design bounds, compute valid catheter paths, and obtain new/optimized catheter shape parameters that would drive implant success in a particular population (e.g., having those anatomy design bounds).
a data setincluding, e.g., anatomy/catheter design bounds, compute valid catheter paths, and obtain new/optimized catheter shape parameters that would drive implant success in a particular population (e.g., having those anatomy design bounds).
the toolmay include preoperative/perioperative decision making, backwards-looking judgments about how current catheter profiles have performed in the past, intraoperative guidance, and optimizing future catheter designs.
the toolmay include determining one or more optimal catheter profiles from a plurality of catheter profiles based on a plurality of anatomy parameters and a plurality of catheter parameters.
the toolmay include evaluating a catheter profile in view of a plurality of anatomy parameters and a plurality of catheter parameters.
the toolmay include determining guidance for navigating a catheter profile within an anatomy based on a plurality of anatomy parameters and a plurality of catheter parameters.
the toolmay include designing one or more optimal catheter profiles based on a catheter path having a plurality of anatomy parameters.
FIG. 1is a flow diagram that illustrates one example of a method for determining one or more optimal catheter profiles from a plurality of catheter profiles according to the present disclosure.
FIG. 2is a conceptual diagram of a plurality of catheter profiles positioned with an anatomy along a variety of different paths according to the present disclosure.
FIG. 3is a flow diagram that illustrates one example of a method for evaluating a catheter profile in view of a plurality of anatomy parameters according to the present disclosure.
FIG. 4Ais a representative image of an illustrative human heart having one configuration of an atrial superior vena cava (SVC)/inferior vena cava (IVC) junction.
SVCatrial superior vena cava
IVCinferior vena cava
FIG. 4Bis a representative image of another illustrative human heart having a different configuration of the atrial superior vena cava (SVC)/inferior vena cava (IVC) junction as compared to FIG. 4A.
SVCatrial superior vena cava
IVCinferior vena cava
FIG. 4Cis a representative image of tool design (e.g., catheter profile) for a human implant shown in relation to an animal heart anatomy.
tool designe.g., catheter profile
FIG. 5is a flow diagram that illustrates one example of a method for determining guidance for navigating a catheter profile within an anatomy according to the present disclosure.
FIG. 6is a flow diagram that illustrates one example of a method for designing one or more optimal catheter profiles having a plurality of catheter parameters according to the present disclosure.
FIG. 7is a schematic illustration of a system including an exemplary system for selecting or designing an optimal catheter profile for a particular patient or group of patients.
the present disclosuregenerally provides a catheter design tool or system and methods thereof for selecting or designing an optimal catheter profile for a particular patient or group of patients.
the tool or systemmay include a data set (e.g., input into the system) pertaining to a plurality of anatomy parameters and a plurality of catheter parameters to determine one or more catheter profiles that allow the best implant efficacy for a particular patient or group of patients.
the toolmay evaluate the efficacy of a particular catheter profile for use with a particular patient, the most optimal catheter profile from a plurality of catheter profiles for use with a particular patient, and/or the most optimal catheter profile from a plurality of catheter profiles for use with a group of patients (e.g., divided by anatomic measurements or anatomic correlation with demographics).
the toolmay increase efficiency by selecting or designing the most effective catheter profile for a particular anatomy and eliminating potential waste created by using multiple catheter profiles to find the “best” catheter profile.
catheter profileas described herein may include a physical catheter (and the features thereof) or a representation of a catheter (and the features thereof).
the data set(particularly the plurality of anatomy parameters) may be used to determine an optimal catheter path within one or more anatomies such that an optimal catheter profile may be designed having a plurality of catheter parameters.
the optimal catheter profilemay be designed to be suitable for a particular anatomy or for a majority of anatomies (e.g., within a group).
the toolmay be used to provide guidance for navigating a catheter profile within an anatomy based on the data set.
the term “or”refers to an inclusive definition, for example, to mean “and/or” unless its context of usage clearly dictates otherwise.
the term “and/or”refers to one or all of the listed elements or a combination of at least two of the listed elements.
FIG. 1shows a process 100 of determining one or more optimal catheter profiles from a plurality of catheter profiles based on a plurality of catheter parameters of the plurality of catheter profiles and a plurality of anatomy parameters. For example, there may be various instances in which a most optimal catheter profile is selected for an individual person (e.g., having a specific anatomy) or a group of people (e.g., having various anatomies).
this informationmay be useful in settings including, e.g., in a clinic or operating room when treating a single patient, when determining which catheter profile functions most optimally for a specific group of people, when presented with a collection of various catheter profiles and determining which functions most optimally, when ranking a collection of various catheter profiles for one person or multiple people, etc.
the process 100may include receiving 110 a plurality of anatomy parameters related to one or more anatomies.
specific parameters or characteristics of a patient’s anatomymay be input into a tool (e.g., through a system or controller) in order to evaluate the catheter profile.
the plurality of anatomy parametersmay include venous or arterial boundary shapes and distances, locations of anatomic targets relative to other anatomic landmarks, atrial wall locations, valve structure, coronary sinus ostia, coronary artery takeoffs, ventricular free and septal wall locations, orientation, endocardial shape (e.g., concave, convex), etc.
the plurality of anatomy parametersmay be derived in a variety of different ways.
the one or more anatomiesmay be imaged to determine the plurality of anatomy parameters.
the imagingmay include magnetic resonance imaging (MRI), fluoroscopy, cineradiography, biplane fluoroscopy, biplane cineradiography, computed tomography (CT), intraoperative 2D/3D imaging system (O- Arm), ultrasound (US), a transesophageal echocardiography (TEE), intra-cardiac echocardiography (ICE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), electromechanical wave imaging (EWI), neuro-endoscopy, single photon emission computed tomography (SPECT), magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography (PET), optical coherence tomography (OCT), optical imaging spectroscopy (OIS), a magnetic resonance spectroscopy (MRS), dynamic susceptibility contrast (DSC)
MRImagnetic
the one or more anatomiesmay be measured in any suitable way such as, e.g., by segmenting anatomic boundaries from volumetric images (e.g., to extract anatomic boundaries) or by computing a best-fit volume from two or more perspective images of an anatomy.
2D imagese.g., ultrasound planes
a usermay manually input the plurality of anatomy parameters into a system or controller of the tool (e.g., due to known values of the plurality of anatomy parameters).
the plurality of anatomy parametersmay be provided through a database of biometric information.
the plurality of anatomy parametersmay be selected and input as desired by a user to represent the one or more anatomies.
the one or more anatomiesmay correlate to a demographic group.
the one or more anatomiesmay be grouped into a plurality of demographic groups.
the demographic groupmay be identified within one or more of, e.g., height, body mass index (BMI), ethnicity, gender, disease state, etc.
BMIbody mass index
the demographic groupmay be used to approximate one or more anatomy parameters to determine one or more optimal catheter profiles for the anatomies of the demographic group, as will be discussed further herein.
the process 100may also include defining 120 a plurality of catheter profiles (e.g., providing a plurality of catheters, establishing a plurality of available catheter profiles, etc.).
the plurality of catheter profilesmay draw from all different types of existing catheter profiles that are manufactured.
the plurality of catheter profilesmay be a subset of catheter profiles (e.g., the catheter profiles that are presently available to a user).
the catheter profilemay include a cardiac or neurostimulation lead delivery catheter (e.g., an electric or pacing lead), a peripheral catheter (e.g., balloon or stent delivery systems), a miniaturized leadless pacemaker delivery catheter, a catheter for advancing a guidewire, and/or a delivery catheter (e.g., to deliver drugs or medication).
a cardiac or neurostimulation lead delivery cathetere.g., an electric or pacing lead
a peripheral cathetere.g., balloon or stent delivery systems
miniaturized leadless pacemaker delivery cathetere.g., a catheter for advancing a guidewire
a delivery cathetere.g., to deliver drugs or medication
Each catheter of the plurality of catheter profilesmay include a plurality of catheter parameters.
each of the catheter profilesmay differ based on a variety of different parameters or characteristics.
the plurality of catheter parameters of the plurality of catheter profilesmay define shapes (e.g., arclengths, curvatures), stiffness, compliance, lengths (e.g., of various stiffness or compliance), wall thickness, diameter, etc.
the process 100may include generating 130 a catheter path for each of the plurality of catheter profiles within the one or more anatomies.
generating the catheter path for each of the plurality of catheter profilesmay include simulating the anatomy 150 and the catheter path 160 for each of the catheter profiles extending therethrough.
the anatomy 150may be segmented based on portions that interact with the catheter profile and specific catheter anatomy contact points and implant targets may be measured.
the pre-shaped catheter paths 160 for each of the plurality of catheter profilesmay be imported into the segmented anatomy, e.g., as shown in FIG. 2.
These catheter pathsmay represent a variety of different catheter parameters or pre-shapes (e.g., rigid or compliant catheter sections).
the catheter paths for each catheter profilemay enforce shape and stiffness restrictions to ensure compatibility with anatomy. Thereafter, catheter paths that collide with the anatomy may be eliminated or considered incompatible, leaving the catheter paths that are possible. In one or more embodiments, the process may be repeated with multiple anatomies such that catheter paths may be generated for each anatomy of multiple anatomies.
the process 100may include determining 140 one or more optimal catheter profiles from a plurality of catheter profiles, as shown in FIG. 1.
optimalmay refer to one or more catheter profiles that are best suited for a particular procedure or application or better suited than the remaining catheter profiles.
optimalmay be defined by a clinical outcome, which may be determined by the catheter profile’s ability to deliver therapy in the correct location and in the correct trajectory.
a good metric for catheter efficacy or determining an optimal catheter profilemay be defined by procedure time (e.g., shorter procedure times may equal less radiation, less opportunity for infection, and/or more efficient operation room scheduling).
the optimized catheter profiles or shapesmay be reported or displayed.
the optimized catheter profilesmay be reported or displayed by, for example, computer display, IP sheet or matrix, using parameters to drive the user (e.g., the selector) into certain catheter profiles.
a computer decision treemay assist in potential catheter profile matches based on what you want to do.
the various catheter profilesmay be auto mapped for a specific anatomy based on success rate or performance.
the processmay include digital manipulation of a catheter profile of the plurality of catheter profiles in a computer heart model based on geometric boundary conditions (e.g., the plurality of anatomy parameters). For example, the orientation of the superior vena cava (SVC), location of the coronary sinus (CS) ostium, and angle of the CS body to the right atrium may assist in guiding the user through a series of virtual procedure steps aimed at getting and engaging the catheter profile with the CS.
SVCsuperior vena cava
CScoronary sinus
the alignment of the catheter tip to the body of the CSmay be the final indicator of how well or poorly the catheter profile may align with and engage the CS.
Catheter profile designs that are closer to the CS ostium (e.g., across the patient population) and aligned well with the CS body after manipulation (e.g., across the patient population)may be deemed to be the best design (e.g., optimal) for that population
the one or more optimal catheter profilesmay include a single catheter profile that best suits the one or more anatomies.
the one or more optimal catheter profilesmay include multiple catheter profiles that equally suit the one or more anatomies (e.g., essentially equivalents).
the one or more optimal catheter profilesmay pass a specified threshold upon which the catheter profile is determined to be “optimal.”
the different types of thresholdmay include proximity to target or implant locations, the orientation of the catheter tip relative to a target, fit within the anatomy of interest (e.g., knowing whether the catheter profile is too big or too small for its intended purpose before the catheter is inserted into the patient), etc.
the one or more optimal catheter profilesmay include at least one of the one or more optimal catheter profiles that may be ranked or grouped into tiers. Further, the one or more optimal catheter profiles may be identified with various advantages or disadvantages relative to one another.
determining the one or more optimal catheter profilesmay include eliminating that catheter profiles that are not applicable to or compatible with the one or more anatomies (e.g., leaving the catheter profiles that perform the intended function).
the catheter profiles of the plurality of catheter profiles for which the catheter path collides with portions of the one or more anatomymay be eliminated.
the one or more optimal catheter profilesmay simply be a collection of catheter profiles that were not eliminated from the plurality of catheter profiles (e.g., ones that are compatible).
determining the one or more optimal catheter profiles from the plurality of catheter profilesmay include determining the one or more optimal catheter profiles for a demographic group (e.g., from a plurality of demographic groups).
the demographic groupmay be strongly associated with one or more anatomy parameters that specifically fit one or more catheter profiles of the plurality of catheter profiles.
the one or more optimal catheter profilesmay be identified for a specific demographic group.
determining the one or more optimal catheter profiles from the plurality of catheter profilesmay include identifying locations within the one or more anatomies (e.g., based on the plurality of anatomy parameters) and comparing the plurality of catheter profiles to desired locations within the one or more anatomies.
the catheter profilemay contact the right ventricular outflow tract in a direction perpendicular to the septal wall in order to deliver a (e.g., miniaturized) leadless pacemaker, or the catheter profile may contact the CS ostium in a direction allowing cannulation in order to deliver a left heart lead, or the catheter profile may contact the atrial septum in order to puncture into the bundle of His, High or Mid septal wall (e.g., for LBBAP), etc.
a leadless pacemakere.g., miniaturized leadless pacemaker
the catheter profilemay contact the CS ostium in a direction allowing cannulation in order to deliver a left heart lead
the catheter profilemay contact the atrial septum in order to puncture into the bundle of His, High or Mid septal wall (e.g., for LBBAP), etc.
the catheter profilemay extend within the pulmonary artery branch or branches to deliver a device/sensor into the branch or branches, or the catheter profile may extend within the lung airways (e.g., bronchioles) to excise tissue/biopsy, or the catheter profile may extend through coronary arteries for stent delivery, or the catheter profile may extend through the pulmonary veins for pulmonary vein isolation (e.g., ablation) and for cryo-therapy.
the lung airwayse.g., bronchioles
the catheter profilemay extend through coronary arteries for stent delivery
the catheter profilemay extend through the pulmonary veins for pulmonary vein isolation (e.g., ablation) and for cryo-therapy.
the identified locationsmay be used in Mitral valve repair (e.g., where catheters may be used to cross an existing valve or navigate through an existing valve frame) for structure heart cases.
the catheter profilemay travel along a contralateral approach in peripheral stenting of the legs (e.g., approach is in one leg, goes up and over through the abdomen, and back down the other leg). Therefore, in one or more embodiments, the process may include evaluating a position of each catheter profile within the anatomy (e.g., to determine whether the catheter profile may properly interact with a portion of the anatomy as desired).
FIG. 3illustrates a method 200 of evaluating a catheter profile in view of an anatomy having a plurality of anatomy parameters.
a usermay only have access to a single catheter profile having a set of parameters or characteristics.
the catheter profilemay be evaluated (e.g., how well does the catheter profile work) as it pertains to the efficacy (e.g., for implantation, stimulation, therapy (e.g., drug, biologic, or electrical) delivery, fixation, etc.) for a specific anatomy.
the efficacye.g., for implantation, stimulation, therapy (e.g., drug, biologic, or electrical) delivery, fixation, etc.
the method 200may include receiving 210 a plurality of anatomy parameters related to an anatomy.
a toole.g., through a system or controller
the plurality of anatomy parametersmay include venous or arterial boundary shapes and distances, locations of anatomic targets relative to other anatomic landmarks, atrial wall locations, valve structure, coronary sinus ostia, coronary artery takeoffs, ventricular free and septal wall locations, orientation, endocardial shape (e.g., concave, convex), etc.
the plurality of anatomy parametersmay be derived in a variety of different ways.
the one or more anatomiesmay be imaged to determine the plurality of anatomy parameters.
the imagingmay include magnetic resonance imaging (MRI), fluoroscopy, cineradiography, biplane fluoroscopy, biplane cineradiography, computed tomography (CT), intraoperative 2D/3D imaging system (O- Arm), ultrasound (US), a transesophageal echocardiography (TEE), intra-cardiac echocardiography (ICE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), electromechanical wave imaging (EWI), neuro-endoscopy, single photon emission computed tomography (SPECT), magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography (PET), optical coherence tomography (OCT), optical imaging spectroscopy (OIS), a magnetic resonance spectroscopy (MRS), dynamic susceptibility contrast (DSC) MRI, a fluid-attenuated inversion recovery (FLAIR), rotational ang
the one or more anatomiesmay be measured in any suitable way such as, e.g., by segmenting anatomic boundaries from volumetric images (e.g., to extract anatomic boundaries) or by computing a best-fit volume from two or more perspective images of the anatomy.
2D imagese.g., ultrasound planes
a usermay manually input the plurality of anatomy parameters into a system or controller of the tool (e.g., due to known values of the plurality of anatomy parameters).
the method 200may also include defining 220 a catheter profile having a plurality of catheter parameter profiles (e.g., providing a catheter, establishing a catheter profile, etc.).
the plurality of catheter parameters of the catheter profilemay include shapes (e.g., arclengths, curvatures), stiffness, compliance, lengths (e.g., of various stiffness or compliance), wall thickness, diameter, etc.
the catheter profilemay include a cardiac or neurostimulation lead delivery catheter (e.g., an electric or pacing lead), a peripheral catheter (e.g., balloon or stent delivery systems), a miniaturized leadless pacemaker delivery catheter, a catheter for advancing a guidewire, and/or a delivery catheter (e.g., to deliver drugs or medication).
the method 200may include evaluating 230 the catheter profile in view of the plurality of anatomy parameters.
the catheter profilemay be evaluated in view of the plurality of anatomy parameters in a variety of different ways. For example, evaluating the catheter profile by determining a position of the catheter profile relative to an implant and/or stimulation region.
the plurality of anatomy parametersmay be used to establish the location of the implant/ stimulation region.
a particular portion of the catheter profilemay be evaluated to position the portion of the catheter profile relative to a location within the anatomy. For example, a location within the anatomy may be identified based on the plurality of anatomy parameters and the catheter profile may be compared to the locations within the anatomy. Also, for example, the catheter profile may be evaluated on whether or not the catheter profile is compatible with the anatomy.
a demographic groupmay define the plurality of anatomy parameters. Therefore, a specific catheter profile may be evaluated in view of the demographic group representing the plurality of anatomy parameters.
the demographic groupmay be identified within a variety of different categories. For example, the demographic group may be identified within one or more of height, BMI, ethnicity, gender, disease state, etc.
the method 200may include determining 240 a performance of the catheter profile.
the performance of the catheter profilemay be represented in a variety of different ways. For example, if evaluating the catheter profile by determining whether or not a catheter profile is compatible with the anatomy, the performance metric may be determined that the catheter profile is compatible or incompatible. Further, in one or more embodiments, the performance metric may be relayed to the physician by indicating the catheter profile is compatible or incompatible, by superimposing the catheter profile on the patient’s anatomy and color-coding regions of the catheter profile that fall outside of or near the boundaries of the anatomy, by providing a list of catheter shapes that are compatible with the patient’s anatomy, etc.
FIGS. 4A and 4Billustrate anatomic variation in the atrial superior vena cava (SVC)/inferior vena cava (IVC) junction between two different hearts.
SVCatrial superior vena cava
IVCinferior vena cava
FIG. 4Cillustrates a tool design (e.g., a catheter profile) for a human implant that does not fit the anatomy structure of an animal. This information allows the user to identify early on the expected performance of a given tool or catheter profile prior to further implementation or use.
FIG. 5illustrates a method 300 of determining guidance for navigating a catheter profile within an anatomy. For example, it may be beneficial for a user to understand the best path for navigating a specific catheter profile within a particular anatomy. By customizing the navigation based on the specifics for an individualized procedure, the user may more effectively carry out the procedure.
the method 300may include receiving 310 a plurality of anatomy parameters related to an anatomy.
specific parameters or characteristics of a patient’s anatomymay be input into a tool (e.g., through a system or controller) in order to provide guidance for the catheter profile.
the plurality of anatomy parametersmay include venous or arterial boundary shapes and distances, locations of anatomic targets relative to other anatomic landmarks, atrial wall locations, valve structure, coronary sinus ostia, coronary artery takeoffs, ventricular free and septal wall locations, orientation, endocardial shape (e.g., concave, convex), etc.
the plurality of anatomy parametersmay be derived in a variety of different ways.
the one or more anatomiesmay be imaged to determine the plurality of anatomy parameters.
the imagingmay include magnetic resonance imaging (MRI), fluoroscopy, cineradiography, biplane fluoroscopy, biplane cineradiography, computed tomography (CT), intraoperative 2D/3D imaging system (O- Arm), ultrasound (US), a transesophageal echocardiography (TEE), intra-cardiac echocardiography (ICE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), electromechanical wave imaging (EWI), neuro-endoscopy, single photon emission computed tomography (SPECT), magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography (PET), optical coherence tomography (OCT), optical imaging spectroscopy (OIS), a magnetic resonance spectroscopy (MRS), dynamic susceptibility contrast (DSC)
MRImagnetic
the one or more anatomiesmay be measured in any suitable way such as, e.g., by segmenting anatomic boundaries from volumetric images (e.g., to extract anatomic boundaries) or by computing a best-fit volume from two or more perspective images of the anatomy.
2D imagese.g., ultrasound planes
a usermay manually input the plurality of anatomy parameters into a system or controller of the tool (e.g., due to known values of the plurality of anatomy parameters).
the method 300may also include defining 320 a catheter profile having a plurality of catheter parameters (e.g., providing a catheter, establishing a catheter profile, etc.).
the plurality of catheter parameters of the catheter profilemay include shapes (e.g., arclengths, curvatures), stiffness, compliance, lengths (e.g., of various stiffness or compliance), wall thickness, diameter, etc.
the catheter profilemay include a cardiac or neurostimulation lead delivery catheter (e.g., an electric or pacing lead), a peripheral catheter (e.g., balloon or stent delivery systems), a miniaturized leadless pacemaker delivery catheter, a catheter for advancing a guidewire, and/or a delivery catheter (e.g., to deliver drugs or medication).
a cardiac or neurostimulation lead delivery cathetere.g., an electric or pacing lead
a peripheral cathetere.g., balloon or stent delivery systems
miniaturized leadless pacemaker delivery cathetere.g., a catheter for advancing a guidewire
a delivery cathetere.g., to deliver drugs or medication
the method 300may include determining 330 guidance for navigating the catheter profile within the anatomy.
the guidance for navigating the catheter profile within the anatomymay include an optimized path within the anatomy.
the guidancemay include evaluating a position of the catheter profile within the anatomy. For example, the guidance may include displaying an image of the catheter profile extending along an optimized path within the anatomy.
the imagingmay be in any suitable form including, e.g., magnetic resonance imaging (MRI), fluoroscopy, cineradiography, biplane fluoroscopy, biplane cineradiography, computed tomography (CT), intraoperative 2D/3D imaging system (O- Arm), ultrasound (US), a transesophageal echocardiography (TEE), intra-cardiac echocardiography (ICE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), electromechanical wave imaging (EWI), neuro-endoscopy, single photon emission computed tomography (SPECT), magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography (PET), optical coherence tomography (OCT), optical imaging spectroscopy (OIS), a magnetic resonance spectroscopy (MRS), dynamic susceptibility contrast (DSC) MRI, a fluid-attenuated inversion recovery (FLAIR), rotational angiography, infrared (IR) imaging, ultraviolet
the systemmay also include determining an optimal site into which the catheter profile may be introduced into the patient.
the plurality of catheter parameters and the plurality of anatomy parametersmay be considered to determine which introduction site may be most efficient for a given procedure.
the location of the catheter profilemay be superposed on top of a previously recorded heart image. The physician may then overlay that image on a real time imaging and “follow the lead” to the correct anatomic location.
a demographic groupmay define the plurality of anatomy parameters. Therefore, guidance for a specific catheter profile may be output for inserting the catheter profile within the anatomy based on the demographic group.
the demographic groupmay be identified within a variety of different categories. For example, the demographic group may be identified within one or more of height, BMI, ethnicity, gender, disease state, etc.
FIG. 6illustrates a method 400 of determining or designing one or more optimal catheter profiles having a plurality of catheter parameters.
a catheter profilemay be designed and manufactured to a particular specification of one person or multiple people (e.g., based on a plurality of anatomy parameters).
an optimal catheter profilecan be designed according to a plurality of catheter parameters that is customized to that one person or multiple people.
the optimal catheter profilemay be manufactured in a short period of time (e.g., using additive manufacturing or 3D printing) to that set of catheter parameters.
a catheter profilecould be designed and manufactured “on-demand” for that one person or multiple people. This may allow the user to design and manufacture an “optimal” catheter profile in a short amount of time such that the “optimal” catheter profile can be used almost immediately.
the method 400may include receiving 410 a plurality of anatomy parameters related to one or more anatomies.
specific parameters or characteristics of a patient’s anatomymay be input into a tool (e.g., through a system or controller) in order to design the optimal catheter profile.
the plurality of anatomy parametersmay include venous or arterial boundary shapes and distances, locations of anatomic targets relative to other anatomic landmarks, atrial wall locations, valve structure, coronary sinus ostia, coronary artery takeoffs, ventricular free and septal wall locations, orientation, endocardial shape (e.g., concave, convex), etc.
the plurality of anatomy parametersmay be derived in a variety of different ways.
the one or more anatomiesmay be imaged to determine the plurality of anatomy parameters.
the imagingmay include magnetic resonance imaging (MRI), fluoroscopy, cineradiography, biplane fluoroscopy, biplane cineradiography, computed tomography (CT), intraoperative 2D/3D imaging system (O- Arm), ultrasound (US), a transesophageal echocardiography (TEE), intra-cardiac echocardiography (ICE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), electromechanical wave imaging (EWI), neuro-endoscopy, single photon emission computed tomography (SPECT), magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography (PET), optical coherence tomography (OCT), optical imaging spectroscopy (OIS), a magnetic resonance spectroscopy (MRS), dynamic susceptibility contrast (DSC)
MRImagnetic
the one or more anatomiesmay be measured in any suitable way such as, e.g., by segmenting anatomic boundaries from volumetric images (e.g., to extract anatomic boundaries) or by computing a best-fit volume from two or more perspective images of the anatomy.
2D imagese.g., ultrasound planes
a usermay manually input the plurality of anatomy parameters into a tool (e.g., using a system or controller).
the method 400may also include generating 420 a catheter path within the one or more anatomies.
the catheter pathmay take into account the plurality of anatomy parameters to determine the optimal path for a specific application.
the catheter pathmay include points of interest (e.g., implant and/or stimulation points) within the one or more anatomies through which the catheter path should travel.
the method 400may include designing 430 one or more optimal catheter profiles according to the catheter path.
Each optimal catheter profilehaving a plurality of catheter parameters.
the one or more optimal catheter profilesmay be designed according to the corresponding plurality of catheter parameters.
the one or more optimal catheter profilesmay include features at specific locations (e.g., anchors, leads, balloons, deliver ports, lumens, markers, etc.) to interact with the points of interest determined along the catheter path.
FIG. 7A functional block diagram of an exemplary system 450 for use with catheter design tools and methods thereof for selecting or designing an optimal catheter profile for a particular patient or group of patients, as described herein, is illustrated in FIG. 7.
the system 450may be representative of any systems or devices described herein for use in determining one or more optimal catheter profiles from a plurality of catheter profiles based on a plurality of catheter parameters of the plurality of catheter profiles and a plurality of anatomy parameters as described in combination with FIG. 1, for use in evaluating a catheter profile in view of an anatomy having a plurality of anatomy parameters as described in combination with FIG. 3, for use in determining guidance for navigating a catheter profile within an anatomy as described in combination with FIG. 5, and/or for use in determining one or more optimal catheter profiles having a plurality of catheter parameters as described in combination with FIG. 6.
the system 450may include a processing apparatus, or a processor, 452, input device(s) 460, and output device(s) 462.
the input device 460may be operably coupled to the processing apparatus 452 and may include any one or more devices configured to allow a user to provide input to the processing apparatus 452.
the input device 460may include any apparatus, structure, or devices configured to receive input from a user.
the input device 460may include one or more keyboards, mice, microphones, touchscreens, smart pens, etc.
the input device 460may be further described in terms of the various input modalities.
the input device 460may be configured to receive touch inputs from a user using a touchscreen display, keystrokes of a keyboard, voice commands, gesture commands, etc.
the input device 460may be configured to provide input capabilities in various locations, mediums, and conditions to, e.g., receive a plurality of anatomy parameters, a plurality of catheter profiles, a plurality of catheter parameters, etc.
the processing apparatus 452may be configured to receive measurements from the various imaging modalities described herein.
the system 450may additionally include output device(s) 462 operably coupled to the processing apparatus 452.
the output device(s) 462may include any one or more devices configured to provide visual and tactile information to a user.
the output device(s) 462may include one or more monitors, screens, liquid crystal display panels, organic light emitting diode panels, tactile displays (e.g., braille or moveable bump displays), lights, etc.
the output device(s) 462may include a decision matrix or tree to follow based on specific parameters under the current circumstances.
the output device(s) 462may include a 3D printer or additive manufacturing device to create or manufacture a catheter profile on location (e.g., in real time).
processing apparatus 452includes data storage 454.
Data storage 454allows for access to processing programs or routines 456 and one or more other types of data 458 that may be employed to carry out the exemplary methods, processes, and algorithms of selecting and/or designing an optimal catheter profile for a particular patient or group of patients.
processing programs or routines 456may include programs or routines for performing computational mathematics, matrix mathematics, Fourier transforms, image registration processes, compression algorithms, calibration algorithms, image construction algorithms, inversion algorithms, signal processing algorithms, normalizing algorithms, deconvolution algorithms, averaging algorithms, standardization algorithms, comparison algorithms, vector mathematics, location tracking, audio comparison, learning algorithms, biomimetic computation, or any other processing required to implement one or more embodiments as described herein.
Data 458may include, for example, anatomy parameters, catheter profiles, catheter parameters, or any other data that may be necessary for carrying out the one or more processes or methods described herein.
the system 450may be controlled using one or more computer programs executed on programmable computers, such as computers that include, for example, processing capabilities (e.g., microcontrollers, programmable logic devices, etc.), data storage (e.g., volatile or non-volatile memory and/or storage elements), input devices, and output devices.
Program code and/or logic described hereinmay be applied to input data to perform functionality described herein and generate desired output information.
the output informationmay be applied as input to one or more other devices and/or processes as described herein or as would be applied in a known fashion.
the programs used to implement the processes described hereinmay be provided using any programmable language, e.g., a high-level procedural and/or object orientated programming language that is suitable for communicating with a computer system. Any such programs may, for example, be stored on any suitable device, e.g., a storage media, readable by a general or special purpose program, computer or a processor apparatus for configuring and operating the computer when the suitable device is read for performing the procedures described herein.
the system 450may be controlled using a computer readable storage medium, configured with a computer program, where the storage medium so configured causes the computer to operate in a specific and predefined manner to perform functions described herein.
the processing apparatus 452may be, for example, any fixed or mobile computer system (e.g., a personal computer or minicomputer).
the exact configuration of the computing apparatusis not limiting and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., control the display of the system 450, the acquisition of data,) may be used.
various peripheral devicessuch as a computer display, mouse, keyboard, memory, printer, scanner, etc. are contemplated to be used in combination with the processing apparatus 452.
the data 458may be analyzed by a user, used by another machine that provides output based thereon, etc.
a digital filemay be any medium (e.g., volatile or non-volatile memory, a CD-ROM, a punch card, magnetic recordable tape, etc.) containing digital bits (e.g., encoded in binary, trinary, etc.) that may be readable and/or writeable by processing apparatus 452 described herein.
a file in user-readable formatmay be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, audio, graphical) presentable on any medium (e.g., paper, a display, sound waves, etc.) readable and/or understandable by a user.
processorssuch as, e.g., one or more microprocessors, DSPs, ASICs, FPGAs, CPLDs, microcontrollers, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, image processing devices, or other devices.
processorssuch as, e.g., one or more microprocessors, DSPs, ASICs, FPGAs, CPLDs, microcontrollers, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, image processing devices, or other devices.
processing apparatusmay generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.
the use of the word "processor”may not be limited to the use of a single processor but is intended to connote that at least one processor may be used to perform the exemplary methods and processes described herein.
Such hardware, software, and/or firmwaremay be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure.
any of the described componentsmaybe implemented together or separately as discrete but interoperable logic devices. Depiction of different features, e.g., using block diagrams, etc., is intended to highlight different functional aspects and does not necessarily imply that such features must be realized by separate hardware or software components. Rather, functionality may be performed by separate hardware or software components, or integrated within common or separate hardware or software components.
the functionality ascribed to the systems, devices and methods described in this disclosuremay be embodied as instructions on a computer-readable medium such as RAM, ROM, NVRAM, EEPROM, FLASH memory, magnetic data storage media, optical data storage media, or the like.
the instructionsmay be executed by the processing apparatus to support one or more aspects of the functionality described in this disclosure.
references to “one embodiment,” “an embodiment,” “certain embodiments,” or “some embodiments,” etc.,means that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of such phrases in various places throughout are not necessarily referring to the same embodiment of the disclosure.
a methodcompri sing : receiving a plurality of anatomy parameters related to one or more anatomies; defining a plurality of catheter profiles, wherein each catheter profile of the plurality of catheter profiles comprises a plurality of catheter parameters; generating a catheter path for each of the plurality of catheter profiles within the one or more anatomies; and determining one or more optimal catheter profiles from the plurality of catheter profiles.
determining the one or more optimal catheter profiles from the plurality of catheter profilescomprises: eliminating catheter profiles of the plurality catheter profiles for which the catheter path collides with portions of the one or more anatomies resulting in a subset of the plurality of catheter profiles; and determining the one or more optimal catheter profiles from the subset of the plurality of catheter profiles.
A3The method according to any A embodiment, further comprising imaging the one or more anatomies to determine the plurality of anatomy parameters.
A4The method according to any A embodiment, wherein the one or more anatomies correlate to a demographic group and wherein determining one or more optimal catheter profiles from the plurality of catheter profiles comprises determining the one or more optimal catheter profiles for the demographic group.
A5.The method according to embodiment A4, wherein the demographic group is identified within one or more of height, BMI, ethnicity, gender, disease state, etc.
A6.The method according to any A embodiment, wherein the plurality of catheter parameters of the plurality of catheter profiles define shapes (e.g., arclengths, curvatures, etc.), stiffness, compliance, lengths, etc.
determining the one or more optimal catheter profiles from the plurality of catheter profilescomprises identifying locations within the one or more anatomies based on the plurality of anatomy parameters and comparing the plurality of catheter profiles to the locations within the one or more anatomies.
A8The method according to any A embodiment, further comprising ranking at least one of the one or more optimal catheter profiles.
A9The method according to any A embodiment, further comprising grouping the one or more anatomies into a plurality of demographic groups, and wherein determining one or more optimal catheter profiles from the plurality of catheter profiles comprises determining the one or more optimal catheter profiles for a demographic group of the plurality of demographic groups.
the catheter profilecomprises a lead catheter or a drug delivery catheter.
a systemcomprising: a storage apparatus storing a plurality of catheter profiles, wherein each catheter profile of the plurality of catheter profiles comprises a plurality of catheter parameters; and computing apparatus comprising processing circuitry and operably coupled to the storage apparatus, the computing apparatus configured to: receive a plurality of anatomy parameters related to one or more anatomies; determine a catheter path for each of the plurality of catheter profiles within the one or more anatomies; and select one or more optimal catheter profiles from the plurality of catheter profiles.
selecting the one or more optimal catheter profiles from the plurality of catheter profilescomprises: eliminating catheter profiles of the plurality catheter profiles for which the catheter path collides with portions of the one or more anatomies resulting in a subset of the plurality of catheter profiles; and determining the one or more optimal catheter profiles from the subset of the plurality of catheter profiles.
the plurality of catheter parameters of the plurality of catheter profilesdefine shapes (e.g., arclengths, curvatures, etc.), stiffness, compliance, lengths, etc.
selecting the one or more optimal catheter profiles from the plurality of catheter profilescomprises identifying locations within the one or more anatomies based on the plurality of anatomy parameters and comparing the plurality of catheter profiles to the locations within the one or more anatomies.
the computing apparatusis further configured to group the one or more anatomies into a plurality of demographic groups, and wherein selecting one or more optimal catheter profiles from the plurality of catheter profiles comprises determining the one or more optimal catheter profiles for a demographic group of the plurality of demographic groups.
BIOThe system according to any B embodiment, wherein the catheter profile comprises a lead catheter or a drug delivery catheter.
a methodcompri sing : receiving a plurality of anatomy parameters related to an anatomy; defining a catheter profile comprising a plurality of catheter parameters; evaluating the catheter profile in view of the plurality of anatomy parameters; and determining a performance of the catheter profile.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises determining a position of the catheter profile relative to an implant/ stimulation region.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises determining whether the catheter profile is incompatible with the anatomy.
a demographic groupdefines the plurality of anatomy parameters, wherein the catheter profile is evaluated in view of the demographic group.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises identifying locations within the anatomy based on the plurality of anatomy parameters and comparing the catheter profile to the locations within the anatomy.
the catheter profilecomprises a lead catheter or a drug delivery catheter.
a systemcomprising: a storage apparatus storing a catheter profile, wherein the catheter profile comprises a plurality of catheter parameters; and computing apparatus comprising processing circuitry and operably coupled to the storage apparatus, the computing apparatus configured to: receive a plurality of anatomy parameters related to an anatomy; evaluate the catheter profile in view of the plurality of anatomy parameters; and determine a performance of the catheter profile.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises determining a position of the catheter profile relative to an implant/ stimulation region.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises determining whether the catheter profile is incompatible with the anatomy.
D4The system according to any D embodiment, wherein the computing apparatus is further configured to image the anatomy to determine the plurality of anatomy parameters.
a demographic groupdefines the plurality of anatomy parameters, wherein the catheter profile is evaluated in view of the demographic group.
D6The system according to embodiment D5, wherein the demographic group is identified within one or more of height, BMI, ethnicity, gender, disease state, etc.
D7The system according to any D embodiment, wherein the plurality of catheter parameters of the catheter profile defines shapes (e.g., arclengths, curvatures, etc.), stiffness, compliance, lengths, etc.
evaluating the catheter profile in view of the plurality of anatomy parameterscomprises identifying locations within the anatomy based on the plurality of anatomy parameters and comparing the catheter profile to the locations within the anatomy.
the catheter profilecomprises a lead catheter or a drug delivery catheter.
a methodcompri sing : receiving a plurality of anatomy parameters related to an anatomy; defining a catheter profile comprising a plurality of catheter parameters; and determining guidance for navigating the catheter profile within the anatomy.
determining guidance for navigating the catheter profile within the anatomycomprises displaying an image of the catheter profile extending along an optimized path within the anatomy.
E4.The method according to any E embodiment, further comprising imaging the anatomy to determine the plurality of anatomy parameters.
E5.The method according to any E embodiment, wherein a demographic group defines the plurality of anatomy parameters, wherein the guidance determined for navigating the catheter profile within the anatomy is determined in view of the demographic group.
determining guidance for navigating the catheter profile within the anatomycomprises evaluating a position of the catheter profile relative to an implant/ stimulation region.
a systemcomprising: a storage apparatus storing a catheter profile, wherein the catheter profile comprises a plurality of catheter parameters; and computing apparatus comprising processing circuitry and operably coupled to the storage apparatus, the computing apparatus configured to: receive a plurality of anatomy parameters related to an anatomy; and determine guidance for navigating the catheter profile within the anatomy.
the guidance for navigating the catheter profile within the anatomycomprises an optimized path within the anatomy.
determining guidance for navigating the catheter profile within the anatomycomprises displaying an image of the catheter profile extending along an optimized path within the anatomy.
a demographic groupdefines the plurality of anatomy parameters, wherein the guidance determined for navigating the catheter profile within the anatomy is determined in view of the demographic group.
determining guidance for navigating the catheter profile within the anatomycomprises evaluating a position of the catheter profile relative to an implant/ stimulation region.
the catheter profilecomprises a lead catheter or a drug delivery catheter.
a methodcomprising: receiving a plurality of anatomy parameters related to one or more anatomies; generating a catheter path within the one or more anatomies; and determining one or more optimal catheter profiles according to the catheter path, each optimal catheter profile having a plurality of catheter parameters.
the plurality of catheter parameters of the one or more optimal catheter profilesdefine shapes (e.g., arclengths, curvatures, etc.), stiffness, compliance, lengths, etc.
generating a catheter path within the one or more anatomiescomprises identifying locations within the one or more anatomies based on the plurality of anatomy parameters and comparing the catheter path to the locations identified within the one or more anatomies.
a systemcomprising: a storage apparatus; and computing apparatus comprising processing circuitry and operably coupled to the storage apparatus, the computing apparatus configured to: receive a plurality of anatomy parameters related to one or more anatomies; generate a catheter path within the one or more anatomies; and determine one or more optimal catheter profiles according to the catheter path, each optimal catheter profile having a plurality of catheter parameters.
the computing apparatusis further configured to image the one or more anatomies to determine the plurality of anatomy parameters.
the plurality of catheter parameters of the one or more optimal catheter profilesdefine shapes (e.g., arclengths, curvatures, etc.), stiffness, compliance, lengths, etc.
generating a catheter path within the one or more anatomiescomprises identifying locations within the one or more anatomies based on the plurality of anatomy parameters and comparing the catheter path to the locations identified within the one or more anatomies.