On-demand cardiovascular catheter shaping

Abstract

A method and apparatus for generating a customized cardiovascular catheter shape based on an individual patient anatomy is disclosed. As a result, the on-demand shaping of the custom catheter can be done in the context of a cardiovascular catheter procedure. This can also allow an existing catheter to be reshaped and used even for patient populations with unique or extreme anatomy or with anatomy that is not common for the type of surgery being performed.

Description

Cardiovascular catheter shaping as needed

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 539,370, filed September 20, 2023, the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates in general to cardiovascular catheters and catheter delivery for interventional cardiovascular procedures.

[0003] During cardiovascular catheterization, physicians rely on a standard bend shape, baked and molded into the catheter, to access convoluted anatomy. While the bend shape is chosen based on average anatomical examples, physicians often manually shape the catheter to better reach the target site. Manual shaping is prone to errors based on guesswork and is heavily reliant on the physician's experience. A catheter shape that does not adequately match the patient's anatomy can lead to difficulty reaching the target site, increasing procedure time and reducing success rates. These problems may be exacerbated in certain patients, such as those with unique or extreme anatomy, pediatric patients, and patients with congenital heart defects. Summary of the Invention

[0004] The technology and system disclosed herein relate to the shaping of custom catheters with shapes and curvatures based on the specific anatomy of a patient.

[0005] This disclosure relates to methods and systems for generating custom shapes of cardiovascular catheters based on individual patient anatomy. This allows for on-demand shaping of custom catheters in hospitals, clinics, or anywhere surgery is being performed. It also enables catheter shaping and configuration in a sufficiently rapid and efficient manner to be integrated into routine cardiovascular catheterization procedures. Furthermore, it allows for the reshaping and reuse of existing catheters, even for patient populations with unique or extreme anatomy or those uncommon for the type of surgery being performed.

[0006] In some embodiments, this disclosure provides methods for shaping patient-specific catheters. These methods may include: providing a catheter with an initial shape; generating a set of vascular system images of the patient; using the vascular system images to determine a planned vascular path to a target site; converting the planned vascular path into three-dimensional shaping coordinates representing the desired catheter shape; providing the three-dimensional shaping coordinates as input data to a catheter shaping device; and reshaping the catheter using the catheter shaping device according to the desired catheter shape. The initial shape of the catheter may include a shapeless catheter, a catheter selected from a set of standard shapes, a catheter pre-shaped by hand to achieve an approximate shape, etc.

[0007] In some respects, vascular system images include CT scans, ultrasound images, or other types of images acquired before or during the execution of this method. In some respects, determining the planned vascular path involves using image analysis algorithms to identify the edges of blood vessels leading to the target location within the patient's body. The planned vascular path may be a single-line path from an entry point within the patient's body to the target location within the patient's body.

[0008] In some aspects, shaping a catheter includes the following steps: positioning the catheter in a catheter shaping apparatus; bending the catheter, for example, using one or more cylindrical rollers, one or more tapered rollers, one or more pistons, or any combination thereof, to form at least a portion of a desired catheter shape; and baking the catheter to solidify the desired shape. The catheter shaped according to this disclosure can be sterilized prior to use.

[0009] In some respects, the desired duct shape can be defined by the principal angle and principal radius, and can be further defined by the secondary angle and secondary radius.

[0010] In some respects, the target location is in the patient's heart, such as in the right atrium or right ventricle.

[0011] In some embodiments, this disclosure provides a custom catheter shaping system. These systems may include: one or more shaping clamps configured to adjustably shape an inserted catheter at one or more locations along the catheter; and a controller configured to receive input data in coordinate form indicating a desired catheter shape and operatively coupled to control the one or more shaping clamps to shape the catheter according to the desired catheter shape.

[0012] In some aspects, the custom catheter shaping system also includes a rotator configured to rotate an inserted catheter about its long axis, wherein a controller is operatively coupled to control the rotator. In some aspects, the one or more shaping fixtures may include cylindrical rollers, tapered rollers, pistons, or other actuator-controlled devices. In some aspects, the custom catheter shaping system may also include one or more actuators configured to adjust the position of the catheter. In some aspects, the custom catheter shaping system may also include a heating element configured to bake the catheter, thereby shaping it into the desired catheter form.

[0013] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description, drawings, and claims. Attached Figure Description

[0014] Figures 1A to 1C are schematic diagrams of typical cardiovascular anatomy, where Figure 1A illustrates the heart, the chambers of the heart and the surrounding vascular system, and the cardiovascular ducts that are navigated through them; Figure 1B illustrates a portion of the venous vascular system; and Figure 1C illustrates a portion of the aortic vascular system.

[0015] Figure 2 is a schematic diagram indicating the shapes of different standard cardiovascular catheters.

[0016] Figure 3 is a high-level process flow describing some aspects of the method of this disclosure.

[0017] Figures 4A and 4B are schematic diagrams illustrating the mapping relationships of different shaping angles and radii that can be utilized at the distal end of the catheter according to some aspects of this disclosure.

[0018] Figure 4C is a diagram defining different patient anatomical configurations according to some aspects of this disclosure, which can be identified in patient images and used to calculate paths to determine customized catheter shapes.

[0019] Figure 5 is a schematic diagram depicting the features of a catheter shaping device according to some aspects of this disclosure.

[0020] Figures 6A and 6B are schematic diagrams depicting features of a catheter shaping device according to some aspects of this disclosure.

[0021] Figures 7A, 7B and 7C are schematic diagrams depicting features of a catheter shaping device according to some aspects of this disclosure.

[0022] Figure 8 is a process flow describing various aspects of the method according to this disclosure. Detailed Implementation

[0023] This disclosure generally provides methods and apparatus for shaping cardiovascular catheters having a customized shape based on a patient's specific anatomy. According to this disclosure, such customized catheters can be shaped on demand at the site of the catheterization procedure to be performed (such as a hospital or clinic) and within a reasonably allocated timeframe for performing such procedures. Furthermore, the methods and systems of this disclosure can incorporate most of the procedures typically performed during cardiovascular catheterization procedures, including: obtaining images of the patient's vascular system (including vessels leading to and surrounding the heart and the heart itself); and selecting a pre-shaped catheter whose shape approximately matches the patient's anatomy.

[0024] In some respects, images such as those typically obtained before surgery (e.g., CT scans, ultrasound images, etc.) can be used to construct a geometric path to a target location within the patient's body. This path can be converted into three-dimensional coordinates, which can then be uploaded to a shaping device used to sculpt the catheter. From CT scans or other images, the edges of blood vessels can be identified. The identified edges can be converted into coordinates for creating a mesh-based path, which can then be uploaded to a machine capable of custom-shaping the catheter.

[0025] Depending on some aspects, shaping equipment can utilize any suitable shaping mechanism or fixture, such as one or more cylindrical or tapered rollers, one or more pistons, or combinations of these elements. Shaping equipment may also include various conduit guides, supports, tracks, etc., to aid in positioning, adjusting, and rotating the conduit to one or more desired positions for shaping. While in place and shaping, the conduit can be heated to form and "bake in" the shape.

[0026] Custom shaping of catheters can take into account the fact that most catheters already have a predetermined shape; have a varying stiffness distribution along the length of the catheter; or both. For example, cardiovascular catheters can be pre-shaped according to standard average vascular anatomy. Additionally, some catheters have a varying stiffness distribution along their length, becoming less stiff at their distal end. In some embodiments, it may be preferable to consider the portion of the catheter being shaped or reshaped (typically the distal end), including taking into account the stiffness of the catheter in that portion. It should be understood that baking time and temperature can be adjusted accordingly.

[0027] As used herein, the term "or" is an inclusive definition, such as meaning "and / or," unless the context clearly specifies otherwise. The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0028] As used herein, the phrases “at least one of” and “one or more of” following the list of elements refer to one or more of the listed elements or any combination of one or more of the listed elements.

[0029] As used herein, the terms “connection” or “link” refer to at least two elements being directly or indirectly attached to each other. An indirect connection may include one or more other elements between the at least two attached elements. Furthermore, in one or more embodiments, an element may be directly or indirectly on or on another element, and intermediate components or layers may be included therebetween. Both terms may be modified by the interchangeable terms “operationally” and “operably” to describe a connection or link configured to allow components to interact to perform said or otherwise known functionality. For example, a controller may be operably connected to a resistance heating element to allow the controller to supply current to the heating element.

[0030] As used herein, any terms relating to location or orientation (such as “proximal,” “distal,” “end,” “outer,” “inner,” etc.) refer to a relative location and do not limit the absolute orientation of the implementation unless the context otherwise clearly specifies.

[0031] Unless otherwise stated, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0032] Reference will now be made to the accompanying drawings, which depict one or more aspects described in this disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope of this disclosure. The same numbers used in the drawings refer to the same parts, steps, etc. However, it should be understood that the use of reference characters to designate elements in a given drawing is not intended to limit elements in another drawing labeled with the same reference characters. Furthermore, the use of different reference characters to designate elements in different drawings is not intended to indicate that elements referenced differently cannot be the same or similar.

[0033] To illustrate a typical cardiovascular anatomy, refer to Figures 1A through 1C, where Figure 1 illustrates the heart and its chambers, as well as the venous and arterial vascular systems that enter and exit the heart. Variations in the cardiac anatomy and vascular pathways leading to and away from the heart between patients can make catheter navigation to target areas, such as those within or around the right ventricle. Such variations can include atrial size, ventricular size, and cardiac orientation. For example, patients with heart failure often have hearts that are larger and / or oriented at a different angle than what might be considered typical, and younger patients often have hearts that are smaller or oriented at a different angle than what might be considered typical.

[0034] Figure 1A depicts a cross-sectional view of a typical cardiac anatomy 130, which includes the superior vena cava 113, right atrium 114, right ventricle 115, pulmonary artery 116, aorta 117, left atrium 118, left ventricle 119, and interventricular septum 120. By way of example, catheter 110 is shown navigating through the superior vena cava 113 and through the right atrium 114 to enter the right ventricle 115, attempting to position the distal end 112 of catheter 110 near a target area located in or around the right ventricle 115.

[0035] Figure 1B depicts a portion of the venous system 140 leading to the right atrium (not shown), indicated by arrow 144. The vessels indicated in this portion of the venous system 140 are the superior vena cava 142, the right brachiocephalic vein 148 and the left brachiocephalic vein 147, the right subclavian vein 146, and the right internal jugular vein 145. By way of example, a catheter (not shown) can be navigated toward the right atrium via path 143A through the right subclavian vein 146 and the right brachiocephalic vein 148, or alternatively via path 143B through the right internal jugular vein 145. The catheter can be shaped to aid in navigation along selected venous pathways to reach the target area.

[0036] Figure 1C depicts a portion of a typical aortic pathway 150, including the aortic arch 152 and arterial branches 154. A catheter (not shown) can be navigated through the aortic pathway 150 via pathway 155. The catheter can be shaped to aid in navigation of the characteristic portion of the aortic arch 152 to reach the target area.

[0037] Figure 2 illustrates five standard cardiovascular catheters 210a to 210e, each with a distal end 212a to 212e designed to roughly match the average anatomy. Each different shape includes multiple bend angles and radii designed to conform to a portion of the vascular pathway as the catheter is navigated toward a target area. The shapes shown in Figure 2 are illustrative and do not represent all standard shapes. In addition to having a distinctive standard shape, catheters may also be provided with a stiffness distribution that varies along the long axis, for example, becoming less stiff at the distal end portion.

[0038] Figure 3 is a high-level process flowchart illustrating the general steps used in the methods and systems according to this disclosure. As indicated in step 350, preoperative planning includes using information such as patient anatomy, including heart size, unique features, etc. Preoperative planning may also include visually examining images of the patient's blood vessels. Based on this initial analysis, a catheter whose shape best matches the case can be selected. As indicated in step 360, a custom catheter shape can be designed based on the patient's vascular images to define a path to the target. Vectors (e.g., in the form of angles and radii that can be converted into coordinates for catheter shaping) can be calculated based on this path. As indicated in step 370, shaping coordinates can be provided to a catheter shaping device that uses these coordinates to shape the catheter using one or more shaping jigs. Once the custom catheter shape is formed and baked to set, the custom catheter is ready for use.

[0039] Because the catheter is customized for the patient, navigation to the target can be completed with greater accuracy in less time. Furthermore, the methods and systems of this disclosure allow for the reshaping of existing catheters, including benefiting from existing standard catheter shapes. Therefore, customized catheter shaping according to this disclosure can be performed with greater accuracy and precision than methods such as manual shaping by a physician, and in less time than methods requiring the complete fabrication of a customized catheter (including execution within the time window typically provided for cardiovascular catheterization procedures).

[0040] Every heart and every vascular pathway is unique. If attempting to reach the same target location (e.g., the right atrium) on the hearts of different patients, a series of catheter geometries are required to navigate to that location if a fixed-shape catheter is used for navigation. These geometries are typically specified using primary bends, secondary bends, and out-of-plane angles. Primary and secondary bends are typically specified based on angles and radii. Figures 4A and 4B illustrate how the bends required to shape the distal end of the catheter are defined. In Figure 4A, two bends are indicated at the distal end 412a of the catheter, one bend being defined by the primary angle P. α and principal radius P r Limited, and another section of the curve is formed by the secondary angle S. α and secondary radius S r Limitations. Figure 4B indicates the offset between the primary and secondary angles in the distal end 412b of the catheter; this offset is referred to as the out-of-plane angle and is determined by P - S. β Defined by these terms, the catheter shaping mechanism has the ability to control the out-of-plane angle of the catheter. Figure 4C is a table relating changes in patient anatomy to their effects on catheter shape or intended adjustment.

[0041] Figure 5 schematically illustrates aspects of an embodiment of the shaping apparatus 500 according to the present disclosure. A conduit 510 is inserted into and held in place by a rotary chuck 508. The rotary chuck 508 allows the conduit 510 to rotate about its elongated axis. The shaping apparatus 500 includes a shaping region 502 on which one or more shaping jigs, such as rollers 504a to 504d, can be positioned. The rollers 504a to 504d are preferably adjustable to control the distance between bends, the angle of the bends, and the radius of the bend to be applied to the conduit 510. A controller (not shown in Figure 5) receives input in the form of shaping coordinates and translates the input into instructions for an actuator (not separately indicated) that controls the rotation and relative movement of the rotary chuck 508 and the shaping jigs 504a to 504d. Heating elements (not indicated), such as heating lamps, may be disposed within the shaping region 502 to bake and shape the conduit.

[0042] Figures 6A and 6B schematically show a front view (Figure 6A) and a side view (Figure 6B) of the same portion of the forming apparatus 600. In Figure 6A, pistons 604a to 604d are positioned around a conduit 610. By independently controlling pistons 604a to 604d, the position of the conduit 610 within the forming apparatus 600 can be adjusted, for example, relative to rollers or other forming fixtures, thereby controlling the application of bending to the conduit 610. In some embodiments, the conduit 610 may be inserted into a guide (not shown), such that pistons 604a to 604d adjust the position of the guide, thereby indirectly controlling the positioning of the conduit 610. In the side view of Figure 6B, an additional set of pistons 606a, 606b, and 606c adjacent to pistons 604a, 604b, and 604c is shown. Pistons 604d and 606d are obscured. As the conduit 610 moves through the shaping device 600, this additional set of pistons provides the conduit with greater freedom of movement and positional adjustment. Alternatively, or in addition to positioning the conduit 610 within the shaping device 600, pistons such as 604a to 604d and 606a to 606d may be used to directly apply bending to the conduit 610.

[0043] Figures 7A to 7C show different views of the shaping apparatus 700. A conduit rod 710 can be loaded into the shaping apparatus 700 such that the conduit 710 is supported by a proximal support 740 and secured to the distal end of the conduit by a distal anchor 720. The distal anchor 720 is adjusted using a radius adjuster 722 to set an appropriate bending radius, and then the tapered roller 702 is rotated using an actuator 730 to form a desired angle. The conduit 710 can then be advanced and re-secured at another location using the distal anchor 720, and the bending process can be repeated for another desired radius and angle. While bending the conduit 710, the conduit can be heated or baked to shape the bend into the rod. The time and temperature of the baking process can be determined by a program / software and are a function of the conduit material, design, and curve radius and angle. A controller (not shown) can be operatively coupled to the actuator 730 such that the controller controls the rotation of the tapered roller 702.

[0044] Figure 8 illustrates the steps of a method performed according to various embodiments of this disclosure. Images of selected portions of the patient's vascular anatomy are generated from CT scans, ultrasound, etc. Images routinely generated during preoperative planning can be used, or imaging can be specifically performed to generate images for use in on-demand catheter shaping. Using commercially available software, the images are processed to identify the edges of blood vessels and cardiac chambers leading to and / or including the target location. The images, including the identified blood vessels and cardiac chambers, are analyzed to generate a desired path to the target location. This analysis can be a combination of software-identified paths and human operator adjustments. Once the path is determined, the shaping path is calculated and converted into three-dimensional coordinates that can be transmitted to the shaping device to control actuators connected to bending clamps and positioning devices, thereby shaping the inserted catheter. The catheter can be removed once it is bent and the patient-customized shape is established in the stem by baking.

[0045] Before use, the shaping catheter is preferably sterilized. Sterilization of the shaping catheter can be aided by sterilizing the parts of the shaping equipment that come into contact with the catheter and / or by routinely replacing these parts. For example, shaping rollers or pistons can be designed to be replaceable, and replacing such parts facilitates sterilization. Replaceable parts can be replaced before each use of the shaping equipment.

[0046] It should be understood that the various aspects disclosed herein can be combined with combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing these techniques may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0047] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a non-transitory computer-readable medium that corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that is accessible by a computer).

[0048] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein may refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, these techniques may be fully implemented in one or more circuit or logic elements.

[0049] As used herein, the term “configured as” may be used interchangeably with the terms “adapted as” or “structured as”, unless otherwise clearly stated in this disclosure.

[0050] Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” cover implementations with plural indicators.

[0051] As used in this article, "having," "including," and "containing" are used in their open-ended sense and usually mean "including but not limited to." It should be understood that "basically composed of" and "composed of" are categorized under "containing."

[0052] References to “one embodiment,” “implementation,” “certain embodiments,” or “some embodiments,” etc., mean that a particular feature, configuration, composition, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of such phrases throughout the document does not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0053] The terms "preferred" and "ideally" refer to embodiments of this disclosure that may provide certain benefits in certain circumstances. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are useless, nor is it intended to exclude other embodiments from the scope of this disclosure.

[0054] The following embodiments illustrate the technical solutions described herein.

[0055] Example 1: A method for shaping a patient-specific catheter, the method comprising: providing a catheter having an initial shape; determining a planned vascular path to a target location using an image of the patient's vascular system; converting the planned vascular path into three-dimensional shaping coordinates representing the desired catheter shape; providing the three-dimensional shaping coordinates as input data to a catheter shaping device; and reshaping the catheter using the catheter shaping device according to the desired catheter shape.

[0056] Example 2: The method according to Example 1, wherein the vascular system images include CT scans or ultrasound images.

[0057] Example 3: The method according to Example 1 or Example 2, wherein determining the planned vascular path includes: using an image analysis algorithm to identify the edges of the blood vessels leading to the target location in the patient's body.

[0058] Example 4: The method according to any one of the foregoing embodiments, wherein the planned vascular path is a single-line path from the entry point in the patient body to the target location in the patient body.

[0059] Example 5: The method according to any one of the foregoing embodiments, wherein the step of shaping the catheter includes: positioning the catheter in the catheter shaping device; bending the catheter using one or more cylindrical rollers, one or more tapered rollers, one or more pistons or any combination thereof to form at least a portion of the desired catheter shape; and baking the catheter to set the desired shape.

[0060] Example 6: According to the method of any one of the preceding embodiments, at least a portion of the desired conduit shape is defined by a principal angle and a principal radius.

[0061] Example 7: According to the method of Example 6, the portion of the desired conduit shape is further defined by a secondary angle and a secondary radius.

[0062] Example 8: The method according to any one of the foregoing embodiments, wherein providing a catheter having an initial shape includes: selecting the catheter from a plurality of standard catheter shapes.

[0063] Example 9: The method according to any one of the foregoing examples, wherein the target location is in the patient's heart.

[0064] Example 10: The method described in Example 9, wherein the target location is in the right atrium.

[0065] Example 11: The method according to Example 9, wherein the target location is in the right ventricle.

[0066] Example 12: The method according to any one of the foregoing embodiments, wherein the initial shape is a predefined standard shape.

[0067] Example 13: The method according to any one of the foregoing embodiments further includes: pre-shaping the catheter by hand before reshaping the catheter using the catheter shaping device.

[0068] Example 14: The method according to any one of the foregoing embodiments further includes sterilizing the catheter after performing the reshaping step.

[0069] Example 15: A custom catheter shaping system comprising: one or more shaping clamps configured to adjustably shape an inserted catheter at one or more locations along the catheter; and a controller configured to receive input data in coordinate form indicating a desired catheter shape and operatively coupled to control the one or more shaping clamps to shape the catheter according to the desired catheter shape.

[0070] Example 16: The system according to Example 15 further includes a rotator configured to rotate the inserted catheter about its long axis, and wherein the controller is operatively coupled to control the rotator.

[0071] Example 17: The system according to Example 15 or Example 16, wherein one or more shaping jigs include cylindrical rollers.

[0072] Example 18: The system according to Example 15 or Example 16, wherein one or more shaping jigs include a tapered roller.

[0073] Example 19: The system according to Example 15 or Example 16, wherein the one or more shaping jigs include a piston.

[0074] Example 20: The system according to Examples 15 to 19 further includes one or more actuators configured to adjust the position of the catheter.

[0075] Example 21: The system according to Examples 15 to 20 further includes a heating element configured to bake the conduit, thereby shaping the desired conduit shape.

Claims

1. A method for shaping a patient-specific catheter, the method comprising: The process involves providing a catheter with an initial shape; using an image of the patient's vascular system to determine a planned vascular path to a target location; converting the planned vascular path into three-dimensional shaping coordinates representing the desired catheter shape; providing the three-dimensional shaping coordinates as input data to a catheter shaping device; and using the catheter shaping device to reshape the catheter according to the desired catheter shape.

2. The method of claim 1, wherein the vascular system images include CT scans or ultrasound images.

3. The method according to claim 1 or claim 2, wherein determining the planned vascular pathway comprises: Identify the edges of blood vessels leading to the target location from the image of the patient's vascular system.

4. The method according to any one of the preceding claims, wherein the planned vascular path is a path from an entry point in the patient body to the target location in the patient body.

5. The method according to any one of the preceding claims, wherein the step of shaping the catheter comprises: Position the catheter in the catheter shaping device; The conduit is bent using one or more cylindrical rollers, one or more tapered rollers, one or more pistons, or any combination thereof to form at least a portion of the desired conduit shape; and the conduit is baked to set the desired shape.

6. The method according to any one of the preceding claims, wherein a portion of the desired conduit shape is defined by a principal angle and a principal radius.

7. The method of claim 6, wherein said portion of the desired conduit shape is further defined by a secondary angle and a secondary radius.

8. The method according to any one of the preceding claims, wherein providing the catheter having an initial shape comprises: Choose the catheter from a variety of standard catheter shapes.

9. The method according to any one of the preceding claims, wherein the target location is in the patient's heart.

10. The method of claim 9, wherein the target location is in the right atrium or in the right ventricle.

11. The method according to any one of the preceding claims, further comprising: Before reshaping the catheter using the catheter shaping device, the catheter is pre-shaped by hand.

12. The method according to any one of the preceding claims, further comprising: The catheter is sterilized after the reshaping step is performed.

13. A custom catheter shaping system, the custom catheter shaping system comprising: One or more shaping clamps are configured to adjustably shape an inserted catheter at one or more locations along the catheter; A controller configured to receive coordinate-based input data indicating a desired catheter shape and operably coupled to control the one or more shaping fixtures to shape the catheter according to the desired catheter shape.

14. The system of claim 13, further comprising a rotator configured to rotate the inserted catheter about its long axis, wherein the controller is operatively coupled to control the rotator.

15. The system of claim 13 or claim 14, wherein the one or more shaping jigs comprise a cylindrical roller, a tapered roller, a piston, or a combination thereof.

16. The system of claims 13 to 15, further comprising one or more actuators configured to adjust the position of the catheter.

17. The system of claims 13 to 16, further comprising a heating element configured to bake the conduit to shape the desired conduit.

Images