Device for shaping the tip of an intravascular catheter

Abstract

A device (10.1) for shaping a tip of an intravascular catheter. The device comprises a housing (16) formed by a top wall, a bottom wall, two side walls and a back wall, forming a shaping chamber (26) accessible through an opening which can be closed by a door. Inside the compartment, the device comprises at least one shaping element (32) mounted to at least one of the top wall, the bottom wall, the side walls or the back wall, which is actuatable to shape a catheter tip portion. Furthermore, the compartment comprises at least one adjustable holding element (30.1, 30.2) which holds the catheter in a position for engagement with the shaping element or guides it towards the shaping element. Furthermore, the compartment comprises a shape shaping element and a shape fixing element to assist in molding the catheter tip and to firmly fix its shape.

Description

Technical Field

[0001] This invention relates to a device designed to shape or form the tip of an intravascular catheter according to the specific procedure employed and the patient’s unique anatomy. Background Technology

[0002] Many minimally invasive medical procedures utilize intravascular catheters to diagnose and treat various conditions.

[0003] These technologies encompass a range of methods: 1. Angiography uses a catheter to inject contrast agent into blood vessels, thereby revealing the intricate network of arteries and veins in the cardiovascular system; 2. Angioplasty and stent placement involve inserting a catheter into a balloon and inflating it to widen narrowed or blocked arteries. Additionally, stents can be placed to maintain the artery's dilation. 3. Interventional radiology involving catheters encompasses a range of procedures, such as catheter-guided embolization, chemoembolization, and catheter-based fluid or abscess drainage. 4. Interventional cardiology utilizes catheters to perform precise, minimally invasive procedures, such as coronary angiography, coronary angioplasty, intravascular valve replacement, intravascular pressure measurement, and electrophysiology; and 5. Vascular surgery uses catheters to establish vascular access and perform a variety of medical functions, such as administering intravenous drugs, placing pacemakers, or performing dialysis.

[0004] These examples represent only a small fraction of specialized medical procedures that incorporate catheters across different disciplines in the diagnosis, treatment, and management of a wide range of conditions.

[0005] The interventional catheters used in these procedures come in various shapes, diameters, and lengths to accommodate the different anatomy of blood vessels and target areas within the cardiovascular system. These different shapes allow medical professionals to navigate winding paths, access specific locations, and perform procedures with optimal precision.

[0006] A general challenge is that, given each patient's unique anatomy, specific catheters are needed for particular procedures. Therefore, healthcare facilities offering a range of catheter-based procedures must maintain a large inventory of catheter types of varying lengths and tip shapes.

[0007] To address this inventory dilemma, Machine Solutions has pioneered a conduit tip forming device designed to mold the distal end of a thermoplastic conduit body using a thermally conductive mold. Thermoforming the distal end of the conduit into the desired circular or tapered configuration involves heating the mold to a specific temperature and then inserting shaft material to a predetermined depth.

[0008] The disadvantage of this device is that it uses a pre-formed mold and the catheter is formed under non-sterile conditions.

[0009] This invention largely solves these problems. Summary of the Invention

[0010] In the following text, the “tip” or “distal tip” of an intravascular catheter (these two terms are used interchangeably) refers to the distal portion of the catheter located between the distal end and the axial segment of the catheter, which is adapted to be non-invasive, thereby reducing the risk of vascular injury during insertion, navigation through, and intravascular procedures in which the catheter is inserted.

[0011] In the following text, the terms “shaping” and “forming” are used interchangeably to describe the process of deforming or reshaping the tip of an intravascular catheter to fit the specific needs of a medical procedure and the patient’s anatomy using mechanical force, pressure or other methods.

[0012] One object of the present invention is to provide a device for shaping or molding the tip of an intravascular catheter, thereby adapting the catheter to the unique requirements of a medical procedure and the patient’s anatomy without the need for a mold to achieve shaping or molding.

[0013] Another object of the present invention is to shape the catheter while maintaining sterility, enabling tip shaping to be performed in a clinical setting rather than at the manufacturing site.

[0014] A first aspect of the present invention provides a device for shaping the tip of an intravascular catheter, comprising: (a) A shell having a top wall, a bottom wall, a pair of side walls and a rear wall, (b) A shaped compartment located within the housing, defined between the inner surface of the top wall, the bottom wall, a pair of side walls, and the rear wall, and having an opening on the front side of the housing. (C) A closure element that movably engages with the housing to open or close an opening. (d) At least one shaping element, engaged with at least a top wall, bottom wall, side wall, or rear wall, which is actuable to move a tip. (e) At least one retaining element located in the compartment, which is adjustable to hold the conduit in position to be engaged by the shaping element.

[0015] At least one shaping element may be a hinged arm extending between a first end and a second end, pivotally engaging at the first end to a wall (top wall, bottom wall, side wall, or rear wall) to extend into the shaping compartment, and including a retaining element at the second end adapted to engage a tip portion, and having at least one joint about which the arm is hinged to move the tip.

[0016] The retaining element may include a pair of clamping elements that are actuated to move from an open position that allows placement of the tip to a closed position to close the tip.

[0017] On the inner surface, the retaining element may include multiple shape-fixing elements that radiate energy onto the tip to harden it so as to fix the shape of the tip once it has been moved.

[0018] Each shaped fixing element can be a light source or a heat source.

[0019] Preferably, the intravascular catheter is made of a UV-curable polymer; therefore, the light source is a UV light source.

[0020] The device may include multiple shaping elements.

[0021] Each of the plurality of shaping elements may be a hinged arm extending between a first end and a second end, pivotally engaged at the first end to extend into the shaping compartment, and adapted at the second end to engage a corresponding tip portion, and having at least one joint about which the arm is hinged to move the tip.

[0022] The hinged arms can be spaced apart in a first (vertical) direction and a second (horizontal) direction at the point where they pivot into the wall.

[0023] The articulated arm can be independently actuated to move the tip.

[0024] Independent actuation of the articulated arms can be achieved through electronic connections, where each arm is integrated into a control system that operates in response to specific tip shape inputs, thereby enabling precise and coordinated control.

[0025] The device may include a control system, with each arm electronically connected to the control system, wherein the control system is adapted to control the movement of each arm in response to input regarding the shape of the tip.

[0026] Alternatively, the multiple shaping elements may include multiple arcuate channels formed within the rear wall and multiple sliding elements, each sliding element being adapted to engage a corresponding channel, each sliding element being independently actuated to move along the channel following an arcuate path, and each sliding element being adapted to engage a corresponding tip portion.

[0027] The length of the curved channel can be gradually reduced.

[0028] Alternatively, the multiple shaping elements may be a first array of actuating rods and tubes, wherein each rod is mounted within a corresponding tube formed in the wall of the housing, and each rod can be independently actuated to protrude from the tube to engage a corresponding portion of the tip.

[0029] Preferably, the tube is formed in the rear wall of the housing.

[0030] The actuating rod can move in a first direction perpendicular to the rear wall to engage the tip and move the tip in a direction parallel to the rear wall.

[0031] In addition, the device may include a second, third, and fourth array of actuating rods and tubes.

[0032] The tubes of the second and third arrays can be formed in the corresponding sidewalls, and the tubes of the fourth array can be formed in the top wall.

[0033] The actuators of the second, third, and fourth arrays can move in corresponding directions parallel to the rear wall to engage the tip and move the tip in a direction parallel to the rear wall.

[0034] The pipes can be arranged in a grid pattern on the rear wall, corresponding side walls, or top wall. Preferably, the grid pattern is a regular orthogonal grid pattern.

[0035] The lever can be independently actuated to move the tip.

[0036] Independent actuation of the levers can be achieved through electronic connections, where each lever is integrated into a control system that operates in response to a specific tip shape input, thereby enabling precise and coordinated control.

[0037] At least one shaping element may include a guide that extends partially between the sidewalls; and a sliding element engaged with the guide that can be actuated to move along the guide to contact a tip.

[0038] The sliding element can be a telescopic pin that can move in a direction perpendicular to the rear wall between a retracted position and an extended position.

[0039] The device may include a control system, each sliding element, rod, or sliding element being electronically connected to the control system, wherein the control system is adapted to control the movement of each sliding element, rod, or sliding element in response to input regarding the shape of the tip.

[0040] The device may include multiple shape-forming elements that transfer energy to the tip portion to help shape the tip before or after it is moved.

[0041] The shape-forming element can be a heating element.

[0042] The heating element can be a radiative heating element, such as an IR or microwave element, which radiates electromagnetic radiation onto the tip to shape the tip before or after it is moved.

[0043] The radiant heating element can be an infrared radiation source, such as an infrared LED, or a microwave radiation source, such as a magnetron.

[0044] Alternatively, the heating element can be an induction heating element.

[0045] Induction heating elements may include conductors in or around conduits, as well as induction coils.

[0046] The induction coil can be coupled to one or more side walls, top walls, or bottom walls.

[0047] The conductor can be a covering that partially surrounds the conduit, a filament that extends through the conduit, or a structural braid integrated into the conduit.

[0048] Preferably, the intravascular catheter is made of a polymer that softens when exposed to heat generated by absorbing electromagnetic radiation.

[0049] Each shape-forming element can be independently actuated to radiate electromagnetic radiation onto the corresponding surface of the tip.

[0050] Independent actuation of the shape-forming elements can be achieved through electronic connections, where each shape-forming element is integrated into a control system that operates in response to a specific tip shape input, thereby achieving precise and coordinated control.

[0051] Each shape-forming element can be electronically connected to a control system adapted to control the on / off state of each shape-forming element in response to input regarding the shape of the tip.

[0052] The device may include multiple shape-fixing elements that transfer energy to the tip portion so as to fix the shape of the tip once the tip has been moved and shaped.

[0053] The shape-fixing element can be a heating element or a light-emitting element.

[0054] The light-emitting element can be a radiation source, such as a UV emitting element, which radiates UV radiation onto the tip.

[0055] Preferably, the intravascular catheter is made of a UV-curable polymer.

[0056] The shape-fixing element can be independently actuated to radiate energy (preferably electromagnetic radiation, more preferably UV radiation) onto the corresponding surface of the tip.

[0057] Shape-fixing elements can be engaged with one or more of the corresponding sidewalls, top walls, or bottom walls.

[0058] Independent actuation of the shape-fixing elements can be achieved through electronic connections, where each shape-fixing element is integrated into a control system that operates in response to a specific tip shape input, thereby achieving precise and coordinated control.

[0059] The shape-fixing element can be electronically connected to a control system adapted to control the open / closed state of each shape-fixing element in response to input about the shape of the tip.

[0060] A second aspect of the invention provides a device for shaping the tip of an intravascular catheter, comprising: (a) A shell having a top wall, a bottom wall, a pair of side walls and a rear wall, (b) A shaped compartment located within the housing, defined between the inner surface of the top wall, the bottom wall, a pair of side walls, and the rear wall, and having an opening on the front side of the housing. (c) At least one shaping element, engaged with at least a top wall, bottom wall, side wall, or rear wall, actuable to move a tip into a certain shape. (d) At least one retaining element located within the compartment, which is adjustable to retain the conduit in the position to be engaged by the shaping element, and (e) At least one shape-forming element located in the compartment is actuable to transfer energy to the tip to shape the tip.

[0061] At least one shape-forming element may be a heating element.

[0062] The heating element can be a radiative heating element, such as an IR or microwave emitting element, which radiates electromagnetic radiation onto the tip to shape the tip.

[0063] The radiant heating element can be an infrared radiation source, such as an infrared LED, or a microwave radiation source, such as a magnetron.

[0064] Alternatively, the heating element can be an induction heating element.

[0065] Radiant heating elements can be mounted on the wall of the housing or integrated into a molded element.

[0066] Induction heating elements may include conductors in or around conduits, as well as induction coils.

[0067] The induction coil can be mounted on the wall of the housing.

[0068] The conductor can be a covering that partially surrounds the conduit, a filament that extends through the conduit, or a structural braid integrated into the conduit.

[0069] The device may include multiple shape-forming elements.

[0070] The device may include at least one shape-fixing element located within a compartment, which is actuable to transfer energy to the tip to fix the shape of the tip.

[0071] The shape-fixing element can be a heating element or a light-emitting element.

[0072] The heating element can be a radiant heating element or a light source, such as a UV emitting element, which radiates UV radiation onto the tip.

[0073] Shape-fixing elements can be mounted on the walls of the housing or integrated into the shaping element.

[0074] The device may include multiple shape-fixing elements.

[0075] At least one shaping element may be a hinged arm extending between a first end and a second end, pivotally engaging at the first end to extend into the shaping compartment, and including a retaining element at the second end adapted to engage a tip, and having at least one joint about which the arm is hinged to move the tip.

[0076] The retaining element may include a pair of clamping elements that are actuated to move from an open position that allows placement of the tip to a closed position to close the tip.

[0077] On the inner surface, the retaining element may include a shape-fixing element or a shape-forming element.

[0078] The device may include multiple shaping elements.

[0079] Each of the plurality of shaping elements may be a hinged arm extending between a first end and a second end, pivotally engaged at the first end to extend into a shaping compartment, and adapted at the second end to engage a corresponding tip, and having at least one joint about which the arm is hinged to move the tip.

[0080] The hinged arms may be spaced apart in a first direction and a second direction at the point of pivot engagement with the wall.

[0081] The articulated arm can be independently actuated to move the tip.

[0082] Alternatively, the multiple shaping elements may include multiple arcuate channels formed within the rear wall and multiple sliding elements, each sliding element being adapted to engage a corresponding channel, each sliding element being independently actuated to move along the arcuate path of the channel, and each sliding element being adapted to engage a corresponding tip.

[0083] The length of the curved channel can be gradually reduced.

[0084] Alternatively, the multiple shaping elements may be a first array of actuating rods and tubes, wherein each rod is mounted within a corresponding tube formed in the wall of the housing, and each rod can be independently actuated to protrude from the tube to engage a corresponding portion of the tip.

[0085] Preferably, the tube is formed in the rear wall of the housing.

[0086] The actuating rod can move in a first direction perpendicular to the rear wall to engage the tip and move the tip in a direction parallel to the rear wall.

[0087] In addition, the device may include a second, third, and fourth array of actuating rods and tubes.

[0088] The tubes of the second and third arrays can be formed in the corresponding sidewalls, and the tubes of the fourth array can be formed in the top wall.

[0089] The actuators of the second, third, and fourth arrays can move in corresponding directions parallel to the rear wall to engage the tip and move the tip in a direction parallel to the rear wall.

[0090] The lever can be independently actuated to move the tip.

[0091] At least one shaping element may include a guide that extends partially between the sidewalls; and a sliding element engaged with the guide that can be actuated to move along the guide to contact a tip.

[0092] The sliding element can be a telescopic pin that can move in a direction perpendicular to the rear wall between a retracted position and an extended position.

[0093] The device may include a control system, each sliding element, rod, or sliding element being electronically connected to the control system, wherein the control system is adapted to control the movement of each sliding element, rod, or sliding element in response to input regarding a desired tip shape.

[0094] The device may include a closure element that is movably engaged with the housing to open or close an opening.

[0095] Brief description of the attached figures

[0096] The invention is further described by way of example with reference to the accompanying drawings, in which: Figure 1 The housing of the device used for shaping the tip of an intravascular catheter is shown in a three-dimensional view; Figure 2 yes Figure 1 A sectional side view of the shell; Figure 3 This is a plan view of the rear wall of the compartment within the housing before it is shaped by multiple shaping elements, according to the first embodiment, showing the arrangement of the installed conduit relative to the multiple shaping elements; Figure 4 This is a plan view of the rear wall, showing the configuration of the installed conduit relative to the multiple shaping elements after it has been shaped by them. Figure 5This is a plan view of the rear wall of the compartment within the housing before it is shaped by multiple shaping elements, according to the second embodiment, showing the arrangement of the installed conduit relative to the multiple shaping elements; Figure 6 This is a plan view of the rear wall, showing the area where... Figure 5 After multiple shaping elements are shaped, the installed conduit is configured relative to the multiple shaping elements; Figure 7 The third embodiment is a perspective view of the compartment before it is shaped by multiple shaping elements, showing the arrangement of the installed conduits relative to the multiple shaping elements. Figure 8 The tip of the conduit after being shaped by the component is illustrated in the diagram. Figure 9 The schematic diagram illustrates the role of multiple UV or IR light sources in maintaining the shape of the conduit after the element has been shaped. Figure 10 It is a cross-sectional view of a conduit surrounded by a UV or IR light source; Figure 11 It is a perspective view showing a housing that accommodates the installed conduit and the multiple shaping elements before being shaped by the multiple shaping elements, according to the fourth embodiment; Figure 12 It is a perspective view showing a housing that accommodates the installed conduit and the multiple shaping elements after being shaped by multiple shaping elements, according to the fourth embodiment; Figure 13 It is a perspective view showing a housing for accommodating an installed conduit and a single shaping element according to a fifth embodiment, wherein the shaping element is in an open configuration; Figure 14 It is a 3D diagram, showing... Figure 13 The housing that accommodates the installed conduit, wherein the shaping element in a closed configuration holds the conduit before the element shapes the conduit; Figure 15 It is a 3D diagram, showing... Figure 13 The housing that accommodates the installed conduit, wherein the molding element in a closed configuration holds the conduit after the element molds the conduit; Figure 16 It is a cross-sectional view of a conduit surrounded by a cylindrical retainer of a molding element; Figure 17 This is a perspective view showing a housing for accommodating an installed conduit and a single shaping element according to a sixth embodiment of the present invention; Figure 18 A schematic diagram illustrates a single shaping element and its shape-forming effect on the catheter; Figure 19 , Figure 20 and Figure 21The rear wall of the housing of the device according to the seventh embodiment of the present invention is shown in perspective view in turn; Figure 22 and Figure 23 A device for shaping the tip of an intravascular catheter according to an eighth embodiment of the present invention is schematically shown; Figures 24 to 27 The diagram schematically illustrates a device for shaping the tip of an intravascular catheter according to a ninth embodiment of the present invention; and Figures 28 to 30 The diagram schematically illustrates a device for shaping the tip of an intravascular catheter according to the tenth and eleventh embodiments of the present invention. Detailed Implementation

[0097] Figure 1 A device 10.1 for shaping or molding the tip 12 of an intravascular catheter 14 is shown. Advantageously, when molding the tip of the catheter, it is not necessary to remove the catheter from its sterile packaging 15 to meet the unique requirements of the medical procedure and the patient's anatomy.

[0098] The device 10.1 includes a housing 16 having a top wall 18, a bottom wall 20, a rear wall 22, and a pair of side walls designated 24.1 and 24.2, respectively. A forming chamber 26 is defined within the walls. The housing is open at the front. A closure 28 engages with the housing to open and close the forming chamber.

[0099] In this embodiment, device 10.1 has a pair of retaining elements (designated 30.1 and 30.2, respectively) engaged to the inner surface 32 of the rear wall. The retaining elements are aligned in the Y (operationally vertical) direction and adapted to engage the conduit and retain the conduit in the vertical direction near the inner surface of the rear wall.

[0100] In all embodiments of the invention, the device includes at least one shaping element 32. These embodiments differ fundamentally in the number, structure, configuration, or operation of the shaping elements.

[0101] In this example, the device includes multiple shaping elements, designated 32.1, 32.2, ..., 32.N. Each shaping element is an actuating rod 34, housed within a tube 36 (see...). Figure 8 These tubes are recessed into one or more walls of the housing. For ease of explanation and illustration, this embodiment shows multiple shaped elements mounted within the inner surface of the rear wall. These multiple shaped elements are arranged in a structured orthogonal grid pattern. The device can include shaped elements at any specific density. Figure 2 , Figure 3 and Figure 4 The specific densities shown are chosen for illustrative purposes only.

[0102] Each rod can extend individually from its tube (see...) Figure 8 These rods engage specific portions of the conduit tip 12. Independent actuation of these rods is achieved through electronic integration into a control system (not shown). This control system incorporates a custom-designed software processor, allowing the operator to precisely and coordinately control the shaping element to achieve the desired tip shape. In short, the desired tip shape is input into the system, enabling coordinated control of the shaping element, which then molds the tip into that shape.

[0103] like Figure 4 As shown, only certain shaping elements are actuated to extend their rods and contact the tip to push the tip in the X (horizontal) direction. In the example shown, as illustrated, the shaded shaping elements are or have been actuated to move the tip. Taking the shaping elements in the top row α (labeled 32a, 32b, 32c, and 32d) as an example, lateral movement of the tip to the right is achieved by the rod of element 32b extending first, pushing the tip over element 32c. When the rod of element 32c extends, it pushes the tip further to the right over element 32d, which in turn pushes the tip to its right. This sequential pushing action is repeated in the second row β and similarly in the third row Ω, although a different number of shaping elements are involved in the action in each row.

[0104] As an alternative to or supplement to the array of shaping elements in the inner surface 32 of the rear wall, additional arrays of shaping elements in the inner surfaces of the side walls and top wall (38.1, 38.2, and 40, respectively) provide the device 10.2 with not only in the X direction (e.g., Figure 7 and Figure 8 As shown), and a means of moving the tip in the Z (depth) direction.

[0105] Once the desired tip shape is obtained, that shape can be fixed by the following means.

[0106] exist Figures 19 to 21 In the relevant embodiment 10.7 shown, when the tip 12 is stationary and placed on the shaping element base, instead of some shaping elements being actuated to push the tip into a certain shape, the conduit is moved toward the shaping element base, which has a pre-forming space, and the tip is forced into the pre-forming space to shape the tip.

[0107] like Figure 20 As shown, most shaping elements are actuated to extend the rods, while a few shaping elements (labeled 32a, 32b, 32c, 32d, 32e, and 32f in this example) are not actuated, and the corresponding rods remain retracted within their tubes. As the tip moves relative to the shaping element base, the path formed by the retracted rods within the array of extended rods creates a shaping channel for the tip.

[0108] In another embodiment of the invention, as provided is... Figure 5 and Figure 6 The device shown is 10.3.

[0109] When describing this implementation (and subsequent implementations), similar features will be labeled with the same numbers, and the description will focus on the differences between the implementations.

[0110] The difference between device 10.3 and the aforementioned embodiment lies in the structure and configuration of the shaping element 32. Here, the multiple shaping elements include multiple arc-shaped channels of gradually decreasing length (labeled as 36.1, 36.2, ..., 36.N, respectively) formed in the inner surface 32 of the rear wall, and multiple sliding elements (labeled as 34.1, 34.2, ..., 34.N, respectively), each sliding element being adapted to engage a corresponding channel.

[0111] Each shaping element has a semi-circular clip 42 hinged to a sliding element 34, allowing the clip to open or close for easy retention and release of the catheter.

[0112] After the conduit is positioned inside the forming chamber 26 and its tip is attached to each shaping element 32, each shaping element can be individually activated to move along its corresponding channel 36. These movements follow an arcuate path, wherein the distance traveled is predetermined by the desired tip shape. And, similarly, once the desired tip shape is obtained, that shape can be fixed by means to be described.

[0113] exist Figure 11 and Figure 12 In the third embodiment shown, each shaping element 32 of the device 10.4 is a hinged arm.

[0114] Each articulated arm 32 extends from a first end 44 to a second end 46 into the forming chamber. At the first end, the arm is pivotally connected to the inner surface 38.1 of the sidewall, allowing movement in the Y direction. At the second end, the arm is equipped with a retaining element, which in this example is a tube retaining clip 42 that can be opened and closed to facilitate tube retention and release. The arm has a joint 48. The pivot and joint at the first end provide articulated mobility to the arm, allowing movement in the X, Y, and Z directions.

[0115] After the conduit is positioned inside the forming compartment 26 and its tip is connected to each forming element 32, each articulated arm can be individually activated to move, thereby moving and shaping the tip before its shape is fixed.

[0116] In yet another embodiment, the present invention provides a device 10.5. This device, as... Figures 13 to 16 As shown.

[0117] The device 10.5 may have a single hinged arm 32 (as shown in the figure) or multiple arms similar to the aforementioned embodiment 10.4. A single-arm version is shown and described in the figures for illustrative purposes.

[0118] The fundamental difference between this embodiment and the aforementioned embodiment lies in the configuration of the retaining element 42. In this embodiment, the arm 32 has a cylindrical retaining element 42. The cylindrical element includes a pair of semi-cylindrical elements (50.1, 50.2), which are actuated from an open position that allows placement of a tip (e.g., Figure 13 Move to the closed position (as shown) Figure 14 (As shown) to close the tip.

[0119] When the conduit is installed in the forming compartment 26 and its tip is connected to the hinged arm 32, the arm can be activated to move, thereby moving and shaping the tip before its shape is fixed.

[0120] An implementation plan similar to implementation plan 10.5 (labeled as 10.6) is in Figure 17 and Figure 18 As shown in the image.

[0121] Device 10.6, like device 10.5, has a single hinged arm 32 (as shown). The difference between this embodiment and device 10.5 lies in the configuration of the cylindrical retaining element 42. In this embodiment, the element is segmented, comprising a series of interconnected rings, designated 56.1, 56.2, ..., 56.N. Figure 17 In the unmoved tubular configuration shown, these rings are coaxially stacked in the Y direction and held together along the ridge 58. In this configuration, the cylindrical retaining element 42 holds the tip along a straight vertical line.

[0122] Extending from arm 32 to at least the upper ring (56.1) and lower ring (56.N) are retractable / extendable tendons (60.1, 60.2) and elastic support tendon 62.

[0123] In this example, the tendon 60.1 is retracted to pull the ring 56.1, causing the cylindrical retaining element 42 to bend, thereby causing the retained tip to also bend.

[0124] While the primary method of shaping a tip is through the movement of the shaping element, heating the tip can assist or aid the shaping process and is necessary for fixing and maintaining the new shape. Typically, this involves raising the temperature of the tip above a material-specific temperature, which may be the glass transition temperature but below the melting point of a particular polymer. This heating step can occur before the shaping element moves the tip into the desired shape. After heating and moving the tip into the desired shape, the molecular chains of the polymer at the tip are allowed to rearrange, and then the tip is cooled below the material-specific temperature, which may be the glass transition temperature.

[0125] To achieve this, the device (of any of the aforementioned embodiments) includes a plurality of shape-forming elements, designated 52.1, 52.2, ..., 52.N. Each of these elements is adapted to radiate heat onto the tip to soften it, thereby assisting in shaping the tip before or after it has been moved into a certain shape. The shape-forming elements soften the tip before it is moved, thereby reducing the risk of kinking during bending.

[0126] Another implementation is provided as device 10.8. This implementation is in Figure 22 and Figure 23 As shown in the figure. The distinguishing feature of this embodiment from the aforementioned embodiments (except for embodiment 10.7) is that the conduit 14 is movable relative to the housing 16.

[0127] The tip 12 is partially surrounded by a heating element 52 (described in more detail below). The tip is heated to soften it before the conduit is moved, making it easier to shape.

[0128] Move the catheter in the Y direction, through the retaining (now used as a guide) elements (30.1, 30.2), toward the shaping elements (32.1, 32.2, 32.3, and 32.4). Some shaping elements (which are extendable push rods) can extend (e.g.) Figure 23 As shown), to join the tip around the heated portion 64 to shape the tip.

[0129] exist Figures 24 to 27 The device 10.9 shown is similar to device 10.8 in that the tip 12 is partially surrounded by the heating element 52. This embodiment differs in the configuration and operation of the shaping element 32, which is not a series of push rods but is configured as a pulley element 64 that moves laterally on the cable 66 behind the guide tube, against the rear surface 32. A pin 68 extends from the pulley element in the Z direction.

[0130] The pin is retractable, allowing the pulley element to move behind the conduit without manipulating it. For example... Figure 26 and Figure 27As shown, the pin can extend to engage tip 14 to push it to the left or right to shape the tip.

[0131] Once the tip has been moved by the shaping element of the device (in any of the foregoing embodiments), and moved into or maintained in that shape with the aid of the heating process described above, the shape must be fixed or “baked” into the tip. This is achieved by cooling the conduit to a material-specific temperature (which may be below the glass transition temperature) while maintaining the new shape, thereby fixing the shape.

[0132] For polymer conduits, UV curing helps to fix the tip shape. By directing UV light onto specific surfaces of the tip, those areas can be selectively hardened, thus aiding in shape fixation. After shaping and cooling, UV light can be targeted to specific segments, increasing hardness only where UV light is applied. Different light source elements are activated based on the desired tip configuration, allowing for selective hardening of specific segments. Furthermore, the hardness of each segment can be precisely controlled by adjusting the exposure time.

[0133] This technique can be helpful for specific procedures and tip configurations. For example, it can be applied to the curved portion of a hardened tip to help it maintain its shape during insertion of rigid medical devices (such as folded covered stents) through the lumen of a catheter, or to the distal portion of the hardened tip to make it easier to hook onto the opening of a blood vessel.

[0134] This hardening caused by UV light irradiation increases the cross-linking between molecular chains in the polymer, thus increasing its hardness. This is possible only for certain materials; typically, they will have cross-linking agents within the material itself.

[0135] To achieve this, the device (of any of the aforementioned embodiments) includes a plurality of shape-fixing elements (UV emitting elements), designated 54.1, 54.2, ..., 54.N. These elements are adapted to radiate UV light onto the tip once the tip has been shaped to a certain form in order to fix the shape of the tip.

[0136] Figure 9 and Figure 10 An embodiment is depicted in which UV emitting elements (54.1, 54.2, ..., 54.N) are fixed to the inner surface of a wall (38.1, 38.2, and 40). These elements can be activated independently and controlled by a control system to project UV radiation onto a pointed surface facing these elements.

[0137] Regarding device 10.5, multiple heating elements (52.1, 52.2, ..., 52.N) and UV emitting elements (54.1, 54.2, ..., 54.N) are integrated into a cylindrical retaining element 42, which is engaged with an inner surface to radiate energy onto the element surface facing the tip. Therefore, by controlling which elements are activated, the operator can control which surface receives energy and which surface is softened or hardened to optimize the shape forming and shape-fixing process.

[0138] exist Figure 28 In another embodiment 10.10 shown, the shape-forming elements 52.1, 52.2, ..., 52.N are IR emitting elements fixed to the inner surfaces of the walls (38.1, 38.2, and 40). These elements can be activated independently and controlled by a control system to project IR radiation onto the tip surfaces facing these elements.

[0139] Within the scope of this invention, the shape-forming element is intended to include any electromagnetic radiation source, not limited to IR radiation. For example, the transmitter may be a microwave transmitter.

[0140] The advantage of using an IR emitter to heat the catheter 14 instead of a traditional heating element is that IR radiation can penetrate the transparent sterile barrier 70 of the sterile packaging covering the catheter. The IR radiation heats the catheter by being absorbed by the catheter material and converted into heat energy.

[0141] Figure 29 The device 10.11 is shown, in which the shape-forming elements are induction coils (labeled 52.1, 52.2, and 52.3, respectively), which generate a rapidly changing magnetic field when alternating current (AC) passes through them. Inside the lumen of the catheter, which is encased in aseptic packaging 70, a metal filament 72.1 serves as a conductor. The magnetic field induces eddy currents in the filament, generating resistance and heating the filament, which then conducts heat to the catheter wall.

[0142] As an alternative to metal filaments used as conductors, metal braids, typically included within the conduit wall, provide structural reinforcement, flexibility, and durability, and can be used in induction heating conduits.

[0143] Figure 30 The device 10.11 is shown, wherein the conductor is a hollow cylindrical foil covering 72.2 that partially surrounds the conduit. The foil is heated by induction, and the heat is transferred to the conduit wall.

Claims

1. A device for shaping the tip of an intravascular catheter, comprising: (a) A shell having a top wall, a bottom wall, a pair of side walls and a rear wall, (b) A shaped compartment located within the housing, defined between the inner surface of the top wall, the bottom wall, a pair of side walls, and the rear wall, and having an opening on the front side of the housing. (c) At least one shaping element, engaged with at least the top wall, bottom wall, side wall, or rear wall, actuable to move the tip into a certain shape. (d) At least one retaining element located within the compartment, which is adjustable to retain the conduit in the position to be engaged by the shaping element, and (e) At least one shape-forming element located within the compartment, which is actuable to transfer energy to the tip portion to shape the tip.

2. The apparatus according to claim 1, wherein, The at least one shape-forming element is a heating element.

3. The apparatus according to claim 2, wherein, The heating element may be a radiant heating element.

4. The apparatus according to claim 3, wherein, The radiant heating element can be an infrared or microwave emitting element.

5. The apparatus according to claim 3 or 4, wherein, The radiant heating element is mounted on the wall of the housing or integrated into the shaping element.

6. The apparatus according to claim 2, wherein, The heating element is an induction heating element.

7. The apparatus according to claim 6, wherein, The induction heating element includes a conductor associated with the conduit and an induction coil.

8. The apparatus according to claim 7, wherein, The induction coil is mounted to the wall of the housing.

9. The apparatus according to claim 7 or 8, wherein, The conductor is a covering that partially surrounds the conduit, a filament extending through the conduit, or a structural braid integrated into the wall of the conduit.

10. The device according to any one of claims 1 to 9, comprising at least one shape-fixing element located within the compartment, which is actuable to transfer energy to the tip to harden the tip.

11. The apparatus according to claim 10, wherein, The shape-fixing element is a heating element or a light source.

12. The apparatus according to claim 11, wherein, The heating element is a radiant heating element.

13. The apparatus according to claim 12, wherein, The radiant heating element is a UV emitting element.

14. The apparatus according to any one of claims 10 to 13, wherein, The shape-fixing element is mounted to the wall of the housing or integrated into the shaping element.

15. The apparatus according to any one of claims 10 to 14, comprising a plurality of shape-fixing elements.

16. The apparatus according to any one of claims 1 to 15, wherein, The at least one shaping element is a hinged arm extending between a first end and a second end, pivotally engaging a wall at the first end to extend into the shaping compartment, and including a retaining element at the second end adapted to engage the tip, and having at least one joint about which the arm is hinged to move the tip.

17. The apparatus according to claim 16, wherein, The retaining element includes a pair of clamping elements that are actuated to move from an open position that allows the tip to be placed to a closed position to close the tip.

18. The device according to claim 16 or 17, comprising a plurality of articulated arms, each articulated arm being independently actuable to move the tip.

19. The apparatus according to any one of claims 1 to 15, comprising a plurality of shaping elements, each shaping element having an arcuate channel formed in the rear wall and a sliding element engaging the channel, the sliding element being independently actuated to move along the channel and adapted to engage the tip.

20. The device according to any one of claims 1 to 15, comprising a plurality of shaping elements, each shaping element comprising a tube formed in the wall of the housing and a rod mounted inside the tube, wherein the rod is independently actuated to extend from the tube and engage a corresponding portion of the tip.

21. The apparatus according to any one of claims 1 to 15, wherein, The at least one shaping element includes a guide that extends at least partially between the sidewalls; And a sliding element engaged with the guide, which can be actuated to move along the guide to contact the tip.

22. The apparatus according to claim 21, wherein, The sliding element is a telescopic pin that can move between a retracted position and an extended position in a direction perpendicular to the rear wall.

23. The apparatus according to any one of claims 16 to 22, comprising a control system, each sliding element, rod, or sliding element being electronically connected to the control system, wherein the control system is adapted to control the movement of each sliding element, rod, or sliding element in response to input regarding a desired tip shape.

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