A device for shaping or forming a tip of an endovascular catheter

Abstract

A device (10.1) for shaping the tip of an endovascular catheter. The device comprises a housing (16) formed by a top wall, bottom wall, two sidewalls, and a back wall, creating a forming compartment (26) accessible through an opening that can be closed by a door. Inside the compartment, the device includes at least one shaping element (32), mounted to at least one of the top wall, bottom wall, a sidewall, or the back wall, which is actuatable to shape the catheter tip section. Additionally, the compartment contains at least one adjustable retaining element (30.1,30.2) that holds the catheter in a position for engagement with the shaping elements or guides it toward them. Furthermore, the compartment includes shape-forming and shape-fixing elements to aid in moulding the catheter tip and setting its shape securely.

Description

A DEVICE FOR SHAPING A TIP OF AN ENDOVASCULAR CATHETERFIELD OF THE INVENTION

[0001] This invention pertains to a device designed for shaping or forming an endovascular catheter tip according to the specific procedure employed and the distinct anatomical structure of a patient.BACKGROUND OF THE INVENTION

[0002] Numerous minimally invasive medical procedures utilise endovascular catheters to diagnose and treat various conditions.

[0003] These techniques encompass a range of approaches:1. Angiography employs catheters to inject contrast dye into blood vessels, thereby revealing the intricate network of arteries and veins in the cardiovascular system;2. Angioplasty and stenting employ catheters to insert and inflate a balloon to widen narrowed or obstructed arteries. Additionally, a stent may be placed to uphold the artery's expanded state;3. Interventional radiology, involving catheters, covers a spectrum of procedures such as catheter-directed embolisation, chemoembolisation, and the catheterbased drainage of fluids or abscesses;4. Interventional cardiology employs catheters for precise, minimally invasive procedures, such as coronary artery angiography, coronary angioplasty,endovascular valve replacement, endovascular pressure measurement and electrophysiology; and5. Vascular surgery utilises catheters to establish access to blood vessels, serving diverse medical functions like administering intravenous medications, placing pacemakers, or conducting dialysis.

[0004] These instances are merely a fraction of the specialised medical procedures across diverse disciplines that incorporate catheters in diagnosing, treating, and managing various conditions.

[0005] The interventional catheters used in these procedures come in various shapes, diameters, and lengths to suit the diverse anatomy of blood vessels and target areas within the cardiovascular system. The different shapes enable the medical specialist to navigate tortuous pathways, access specific locations, and perform procedures with optimal precision.

[0006] An overarching challenge arises from the need to have the specific catheter available for a specific procedure, considering each patient's distinct anatomical structure. Consequently, a medical facility offering a range of catheter-based procedures must maintain an extensive inventory of catheter types of varying lengths and tip shapes.

[0007] To address this inventory predicament, Machine Solutions has pioneered a catheter tipping device designed to mould the distal end of a thermoplastic catheter tube, utilising a thermally conductive mould. Thermoforming the distal end of a catheter into a desired rounded or taperedconfiguration involves heating a die to a specific temperature and subsequently inserting the shaft material to a predetermined depth.

[0008] The shortcoming of this device is that it uses pre-shaped dies and forms the catheters non-sterile.

[0009] The invention goes a long way to solving these problems.SUMMARY OF INVENTION

[0010] Hereinafter, “tip” or "distal tip", which terms are used interchangeably, of an endovascular catheter means a distal end portion of the catheter, between a distal end of the catheter and a shaft section of the catheter that is adapted to be atraumatic, reducing the risk of vessel damage during insertion into, navigation through and manipulation within the blood vessel in which the catheter is inserted.

[0011] Hereinafter, the words “shape” and “form” are used interchangeably to describe a process of deforming or reshaping the tip of an endovascular catheter using mechanical force, pressure, or other methods, to suit the specific needs of a medical procedure and a patient's anatomical structure.

[0012] It is an objective of the invention to provide a device for shaping or forming a tip of an endovascular catheter, thereby adapting the catheter to the unique requirements of the medical procedure and the patient's anatomical structure, without the need to use fixed shape dies to achieve the shaping or forming.

[0013] It is a further object of this invention to shape the catheter while remaining sterility, enabling tip shaping in the clinic rather than the point of manufacture.

[0014] A first aspect of the invention provides a device for shaping a tip of an endovascular catheter, which includes:(a) a housing which has a top wall, a bottom wall, a pair of sidewalls and a back wall,(b) a forming compartment within the housing, defined between an inner surface of the top wall, the bottom wall, the pair of sidewalls and the back wall, and which has an opening at a front side of the housing,(c) a closure which is movably engaged to the housing to open or close the opening,(d) at least one shaping element engaged to at least the top wall, the bottom wall, a sidewall, or the back wall, which is actuatable to move the tip,(e) at least one retaining element within the compartment, which is adjustable to hold a catheter in a position to be engaged by the shaping elements.

[0015] The at least one shaping element may be an articulated arm which extends between a first and a second end, which is pivotally engaged to a wall (the top wall, the bottom wall, the sidewalls or the back wall) at the first end to extend into the forming compartment, and which includes, at the second end, a holding element which is adapted to engage the tip section, and which has at least one joint about which the arm articulates to move the tip.

[0016] The holding element may comprise a pair of clamping elements which are actuated to move from an open position to allow placement of the tip to a closed position to enclose the tip.

[0017] On an inside surface, the holding element may include a plurality of shape-fixing elements that radiate energy onto the tip to stiffen the tip to fix the shape of the tip once the tip has been moved.

[0018] Each shape-fixing element may be a light source or a heat source.

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

[0020] The device may include a plurality of shaping elements.

[0021] Each shaping element of the plurality may be an articulated arm, which extends between a first and a second end, which is pivotally engaged to a wall at the first end to extend into the forming compartment, and which is adapted at the second end, to engage a respective tip section, and which has at least one joint about which the arm articulates move the tip.

[0022] The articulated arms may be spaced apart at the point of pivotal engagement with the wall in a first (vertical) direction and a second (horizontal) direction.

[0023] The articulated arms may be independently actuatable to move the tip.

[0024] The independent actuation of the articulated arms may be attained through electronic connectivity, wherein each arm is integrated into a controlsystem that operates in response to a specified tip-shape input, enabling precise and coordinated control.

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

[0026] Alternatively, the plurality of shaping elements may comprise a plurality of arc-shaped channels formed within the back wall and a plurality of sliding elements, each adapted to engage a respective channel, each independently actuatable to move along the channel following an arcuate path, and each adapted to engage a respective tip section.

[0027] The arc-shaped channels may progressively diminish in length.

[0028] Alternatively, the plurality of shaping elements may be a first array of actuating rods and tubes, wherein each rod is mounted within a respective tube formed in a wall of the housing, and each rod is independently actuatable to project from the tube to engage a respective section of the tip.

[0029] Preferably, the tubes are formed in a back wall of the housing.

[0030] The actuating rods may move in a first direction, perpendicular to the back wall, to engage and move the tip in a direction parallel to the back wall.

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

[0032] The tubes of the second and third array may be formed in a respective sidewall, and the tubes of the fourth array may be formed in the top wall.

[0033] The actuating rods of the second, third, and fourth arrays may move in respective directions parallel to the back wall to engage and move the tip in directions parallel to the back wall.

[0034] The tubes may be arranged in a grid pattern on the back wall, respective sidewall, or top wall. Preferably, the grid pattern is a regular orthogonal grid pattern.

[0035] The rods may be independently actuatable to move the tip.

[0036] The independent actuation of the rods may be attained through electronic connectivity, wherein each rod is integrated into a control system that operates in response to a specified tip-shape input, enabling precise and coordinated control.

[0037] The at least one shaping element may include a guide that extends partially between the sidewalls and a gliding element engaged to the guide, actuatable to move along the guide to contact the tip.

[0038] The gliding element may be a retractable pin that is movable in a direction perpendicular to the back wall between a retracted and an extended position.

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

[0040] The device may include a plurality of shape-forming elements that transfer energy to the tip section to aid in forming the shape of the tip prior to or after being moved.

[0041] The shape-forming elements may be heating elements.

[0042] The heating elements may be radiant heating elements, for example, IR or microwave elements, that radiate electromagnetic radiation onto the tip to form the shape of the tip before or after being moved.

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

[0044] Alternatively, the heating elements may be inductive heating elements.

[0045] The inductive heating elements may include a conductor in or around the catheter, and an induction coil.

[0046] The induction coils may engage one or more sidewalls, the top or bottom wall.

[0047] The conductor may be a wrapper that partially encloses the catheter, a filament extending through the catheter, or structural braids integrated within the catheter.

[0048] Preferably, the endovascular catheter is made of polymers, which soften on exposure to heat generated by the absorption of electromagnetic radiation.

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

[0050] The independent actuation of the shape-forming elements may be attained through electronic connectivity, where each shape-forming element is integrated into the control system that operates in response to a specified tip shape input, enabling precise and coordinated control.

[0051] Each shape-forming element may be electronically connected to the control system, which is adapted to control the ON / OFF state of each shapeforming element in response to an input as to the shape of the tip.

[0052] The device may include a plurality of shape-fixing elements that transfer energy to the tip section to fix the shape of the tip once it has been moved and formed.

[0053] The shape-fixing elements may be heating elements or light-emitting elements.

[0054] The light-emitting elements may be radiant light sources, such as UV emitting elements, radiating UV radiation onto the tip.

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

[0056] The shape-fixing elements may be independently actuatable to radiate the energy, preferably electromagnetic radiation, more preferably UV radiation, onto a corresponding surface of the tip.

[0057] The shape-fixing elements may engage one or more of a respective sidewall, the top or bottom wall.

[0058] The independent actuation of the shape-fixing elements may be attained through electronic connectivity, where each shape-fixing element is integrated into the control system that operates in response to a specified tip shape input, enabling precise and coordinated control.

[0059] The shape-fixing elements may be electronically connected to the control system, which is adapted to control each shape-fixing element's ON / OFF state in response to an input as to the shape of the tip.

[0060] A second aspect of the invention provides a device for shaping a tip of an endovascular catheter, which includes:(a) a housing which has a top wall, a bottom wall, a pair of sidewalls and a back wall,(b) a forming compartment within the housing, defined between an inner surface of the top wall, the bottom wall, the pair of sidewalls and the back wall, and which has an opening at a front side of the housing,(c) at least one shaping element engaged to at least the top wall, the bottom wall, a sidewall, or the back wall, which is actuatable to move a tip into a shape,(d) at least one retaining element within the compartment, which is adjustable to hold a catheter in a position to be engaged by the shaping elements, and(e) at least one shape-forming element within the compartment, which is actuatable to transfer energy to the tip to form the shape of the tip.

[0061] The at least one shape-forming element may be heating element.

[0062] The heating element may be radiant heating element, for example, an IR or microwave emitting element, that radiates electromagnetic radiation onto the tip to form the shape of the tip.

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

[0064] Alternatively, the heating element may be inductive heating element.

[0065] The radiant heating element may be mounted on a wall of the housing or integrated into the shaping element.

[0066] The inductive heating element may include a conductor in or around the catheter, and an induction coil.

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

[0068] The conductor may be a wrapper that partially encloses the catheter, a filament extending through the catheter, or structural braids integrated within the catheter.

[0069] The device may include a plurality of shape-forming elements.

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

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

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

[0073] The shape-fixing elements may be mounted on a wall of the housing or integrated into the shaping element.

[0074] The device may include a plurality of shape-fixing elements.

[0075] The at least one shaping element may be an articulated arm which extends between a first and a second end, which is pivotally engaged to a wall at the first end to extend into the forming compartment, and which includes, at the second end, a holding element which is adapted to engage the tip, and which has at least one joint about which the arm articulates to move the tip.

[0076] The holding element may comprise a pair of clamping elements which are actuated to move from an open position to allow placement of the tip to a closed position to enclose the tip.

[0077] On an inside surface, the holding element may include the shape-fixing or shape-forming elements.

[0078] The device may include a plurality of shaping elements.

[0079] Each shaping element of the plurality may be an articulated arm, which extends between a first and a second end, which is pivotally engaged to a wall at the first end to extend into the forming compartment, and which is adapted at the second end, to engage a respective tip, and which has at least one joint about which the arm articulates move the tip.

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

[0081] The articulated arms may be independently actuatable to move the tip.

[0082] Alternatively, the plurality of shaping elements may comprise a plurality of arc-shaped channels formed within the back wall and a plurality of slidingelements, each adapted to engage a respective channel, each independently actuatable to move along the channel following an arcuate path, and each adapted to engage a respective tip.

[0083] The arc-shaped channels may progressively diminish in length.

[0084] Alternatively, the plurality of shaping elements may be a first array of actuating rods and tubes, wherein each rod is mounted within a respective tube formed in a wall of the housing, and each rod is independently actuatable to project from the tube to engage a respective section of the tip.

[0085] Preferably, the tubes are formed in a back wall of the housing.

[0086] The actuating rods may move in a first direction, perpendicular to the back wall, to engage and move the tip in a direction parallel to the back wall.

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

[0088] The tubes of the second and third array may be formed in a respective sidewall, and the tubes of the fourth array may be formed in the top wall.

[0089] The actuating rods of the second, third, and fourth arrays may move in respective directions parallel to the back wall to engage and move the tip in directions parallel to the back wall.

[0090] The rods may be independently actuatable to move the tip.

[0091] The at least one shaping element may include a guide that extends partially between the sidewalls and a gliding element engaged to the guide, actuatable to move along the guide to contact the tip.

[0092] The gliding element may be a retractable pin that is movable in a direction perpendicular to the back wall between a retracted and an extended position.

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

[0094] The device may include a closure which is movably engaged to the housing to open or close the opening.BRIEF DESCRIPTION OF THE DRAWINGS

[0095] The invention is further described by way of examples, with reference to the accompanying Figures in which:Figure 1 isometrically illustrates a housing of a device for shaping a tip of an endovascular catheter;Figure 2 is a sectioned side view of the housing of Figure 1 ;Figure 3 is a view in plan of a back wall of a compartment within the housing showing the arrangement of a mounted catheter relative to a plurality of shaping elements, in accordance with a first embodiment, before being shaped by the elements;Figure 4 is a view in plan of the back wall showing the configuration of a mounted catheter relative to a plurality of shaping elements after being shaped by the elements;Figure 5 is a view in plan of a back wall of a compartment within the housing showing the arrangement of a mounted catheter relative to a plurality of shaping elements, in accordance with a second embodiment, before being shaped by the elements;Figure 6 is a view in plan of the back wall showing the configuration of a mounted catheter relative to the plurality of shaping elements of Figure 5, after being shaped by the elements;Figure 7 is an isometric view of the compartment showing the arrangement of a mounted catheter relative to a plurality of shaping elements, in accordance with a third embodiment, before being shaped by the elements;Figure 8 diagrammatically illustrates a tip of the catheter after being shaped by the elements;Figure 9 diagrammatically illustrates the action of a plurality of UV or IR light sources on maintaining the shape of the catheter post-shaping by the elements;Figure 10 is a view in cross-section of the catheter surrounded by UV or IR light sources;Figure 11 is an isometric view showing the housing containing a mounted catheter and a plurality of shaping elements, in accordance with a fourth embodiment, before being shaped by the elements;Figure 12 is an isometric view showing the housing containing a mounted catheter and a plurality of shaping elements in accordance with a fourth embodiment after being shaped by the elements;Figure 13 is an isometric view showing the housing containing a mounted catheter and a single shaping element, in accordance with a fifth embodiment, with the shaping element in an open configuration;Figure 14 is an isometric view showing the housing containing a mounted catheter of Figure 13, with the shaping element in a closed configuration holding the catheter before the element shapes it;Figure 15 is an isometric view showing the housing containing a mounted catheter of Figure 13, with the shaping element in a closed configuration holding the catheter after the element shapes it;Figure 16 is a view in cross-section of the catheter surrounded by a cylindrical holder of the shaping element;Figure 17 is an isometric view showing the housing containing a mounted catheter and a single shaping element in accordance with a sixth embodiment of the invention;Figure 18 diagrammatically illustrates the single shaping element and its shapeforming action on the catheter;Figures 19, 20 and 21 sequentially isometrically illustrate a back-wall of a housing of the device, in accordance with a seventh embodiment of the invention;Figures 22 and 23 schematically illustrate a device for shaping a tip of an endovascular catheter in accordance with the eighth embodiment of the invention;Figures 24 to 27 schematically illustrate a device for shaping a tip of an endovascular catheter in accordance with the ninth embodiment of the invention; andFigures 28 to 30 schematically illustrate a device for shaping a tip of an endovascular catheter in accordance with a tenth and eleventh embodiment of the invention.DESCRIPTION OF PREFERRED EMBODIMENTS

[0096] Figure 1 illustrates a device 10.1 for shaping or forming a tip 12 of an endovascular catheter 14. Advantageously, in forming the tip of the catheter, to the unique requirements of the medical procedure and the patient's anatomical structure, the catheter need not be removed from its sterile packaging 15.

[0097] The device 10.1 includes a housing 16, having a top wall 18, a base wall 20, a back wall 22 and a pair of sidewalls, respectively designated 24.1 and 24.2. Within the walls, a forming compartment 26 is defined. The housing is open at a front side. A closure 28 is engaged to the housing to open and close the forming compartment.

[0098] In this embodiment, the device 10.1 has a pair of retaining elements (respectively designated 30.1 and 30.2) engaged to a back wall inner surface 32. The retaining elements are aligned in a Y (operatively vertical) direction and adapted to engage the catheter and hold the catheter in the vertical direction, close to the back wall's inner surface.

[0099] The device includes at least one shaping element 32 in all embodiments of the invention. The embodiments fundamentally differ in the number, structure, configuration or operation of the shaping elements.

[0100] In this example, the device includes a plurality of shaping elements designated 32.1 , 32.2, ... , 32. N. Each shaping element is an actuating rod 34, placed within a tube 36 (see Figure 8). These tubes are recessed into one or more walls of the housing. This embodiment is shown with the plurality of shaping elements mounted within the back wall's inner surface for ease of explanation and illustration. This plurality is organised in a structured orthogonal grid-like pattern. The device can include the shaping elements in any particular density, with the particular density illustrated in Figures 2, 3 and 4 only chosen for ease of illustration.

[0101] Each rod can be individually extended (see Figure 8) from its tube to engage a specific section of the catheter tip 12. The independent actuation of these rods is accomplished through electronic integration into a control system (not shown). This control system incorporates a customised software processor, allowing the operator to have precise and coordinated control over the shaping elements to attain the desired tip shape. In simpler terms, inputting the desired tip shape into the system results in the coordinated control of the shaping elements, which then mould the tip into that shape.

[0102] As illustrated in Figure 4, only certain of the shaping elements are actuated to cause the rod to extend into contact with the tip to push the tip in an X (horizontal) direction. In this illustrated example, the shaping elements that are shaded are or were actuated to move the tip, as shown. Taking the top row a ofshaping elements, for example, designated 32a, 32b, 32c and 32d, moving the tip laterally to the right would be brought about by the rod of element 32b extending first, pushing the tip over element 32c. When the rod of this element (32c) extends, it pushes the tip further to the right over element 32d, which in turn pushes the tip to the right of it. This sequential pushing aside action is repeated with the second-row [3, and similarly with the third-row Q, albeit that a different number of shaping elements are involved in the action of each row.

[0103] Having additional arrays of the shaping elements in the sidewall and top wall inner surfaces (respectively, 38.1 , 38.2 and 40), alternatively or in addition to the array of shaping elements in the back wall inner surface 32, provides the device 10.2 with means to move the tip, not just in the X direction, as illustrated in Figures 7 and 8, but in the Z (depth) direction.

[0104] When the desired tip shape is achieved, this shape can be fixed by the means described below.

[0105] In a related embodiment 10.7, illustrated in Figures 19 to 21 , rather than certain of the shaping elements being actuated, whilst the tip 12 is stationary, overlaid on the shaping element bed, to push the tip into shape, the catheter is moved towards the shaping element bed in which a preformed space is provided into which the tip is forced to shape the tip.

[0106] As can be seen in Figure 20, most of the shaping elements are actuated to cause the rods to extend, whilst a few shaping elements (designated 32a, 32b, 32c, 32d, 32e and 32f in this example, are not actuated and the respective rods remain retracted within their tubes. The path formed by the retracted rods,within an array of extended rods, creates a shaping channel to the tip when the tip is moved relatively to the shaping element bed.

[0107] In another embodiment of the invention, a device 10.3 is provided as illustrated in Figures 5 and 6.

[0108] In describing this embodiment (and embodiments that follow), analogous features will bear like designations, and the description will focus on the differences between embodiments.

[0109] Device 10.3 differs from the embodiment described earlier in the structure and configuration of the shaping elements 32. Here, the plurality of shaping elements comprise a plurality of progressively diminishing arc-shaped channels (respectively designated 36.1 , 36.2, ... , 36. N) formed within the back wall inner surface 32, and a plurality of sliding elements (respectively designated 34.1 , 34.2, ... , 34. N), each adapted to engage a respective channel.

[0110] Each shaping element has a semi-circular clip 42, hinged to the sliding element 34, allowing the clip to open or close for easy retention and release of the catheter.

[0111] After the catheter is positioned inside the forming compartment 26 and its tip is connected to each of the shaping elements 32, each shaping element can be individually activated to move along its corresponding channel 36. These movements follow an arcuate path, with the distance travelled predetermined by the desired shape of the tip. And, once again, when the desired tip shape is achieved, this shape can be fixed by means to be described.

[0112] In a third embodiment illustrated in Figures 11 and 12, each shaping element 32 of the device 10.4 is an articulated arm.

[0113] Each articulated arm 32 extends into the forming compartment from the first end 44 to the second end 46. At the first end, the arm is pivotally connected to the inner surface 38.1 of a sidewall, enabling movement in the Y direction. At the second end, the arm is equipped with a holding element which, in this example, is a tube-retaining clip 42 that can be opened and closed for easy catheter retention and release. The arm features a joint 48. Both the pivot at the first end and the joint provide the arm with articulated mobility, allowing movement in the X, Y, and Z directions.

[0114] After the catheter is positioned inside the forming compartment 26 and its tip is connected to each of the shaping elements 32, each articulated arm can be individually activated to move and, in so doing, to move and to shape the tip before its shape is fixed.

[0115] In a further embodiment, the invention provides a device 10.5. This device is illustrated in Figures 13 to 16.

[0116] This device 10.5 can have a single articulated arm 32 (as illustrated) or multiple arms similar to the preceding embodiment 10.4. The single-arm version is represented in the Figures and described for ease of illustration.

[0117] This embodiment fundamentally differs from the earlier described embodiment in the configuration of the retaining element 42. In this embodiment, the arm 32 has a cylindrical retaining element 42. The cylindrical element comprises a pair of semicylindrical elements (50.1 , 50.2) which are actuated tomove from an open position (shown in Figure 13) to allow placement of the tip to a closed position (shown in Figure 14) to enclose the tip.

[0118] With the catheter mounted within the forming compartment 26 and its tip connected to the articulated arm 32, the arm can be activated to move and, in so doing, to move and shape the tip before its shape is fixed.

[0119] An analogue to embodiment 10.5, an embodiment designated 10.6, is illustrated in Figures 17 and 18.

[0120] This device 10.6, like device 10.5, has a single articulated arm 32 (as illustrated). This embodiment differs from device 10.5 in the cylindrical retaining element 42 configuration. In the current embodiment, the element is segmented, comprising a series of interlinked rings, respectively designated 56.1 , 56.2, ... , 56. N. These rings, in the unmoved tubular configuration as illustrated in Figure 17, are co-axially stacked in the Y direction, held together along a spine 58. In this configuration, the cylindrical retaining element 42 retains the tip in a straight vertical line.

[0121] Extending from the arm 32 to at least the upper (56.1 ) and lower (56. N) rings are retractable / extensible tendons (60.1 , 60.2) and elastic support tendons 62.

[0122] In this example, tendon 60.1 is retracted to pull on ring 56.1 to cause the cylindrical retaining element 42 to bend, resulting in the retained tip also bending.

[0123] Although the primary method for shaping the tip is through the actions of the shaping elements, heating the tip can aid or assist this shaping process andis necessary for fixing and retaining the new shape. Typically, this involves raising the tip's temperature above a material-specific temperature, which can be the glass transition temperature but below the melting point of the specific polymer. This heating step can occur before the shaping elements move the tip into the desired shape. After heating and moving the tip into the desired shape, allowing the molecular chains of the polymer of the tip to rearrange, the tip is then cooled to below the material-specific temperature, which can be the glass transition temperature.

[0124] 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 the tip, aiding in forming the shape of the tip, either before or after the tip has been moved into shape. Prior to moving the tip, the shape-forming elements soften the tip, reducing the risk of kinking during bending.

[0125] Another embodiment is provided as device 10.8. This embodiment is illustrated in Figures 22 and 23. What characterises this embodiment over the earlier described embodiments (exception of embodiment 10.7) is that catheter 14 is moveable relative to housing 16.

[0126] The tip 12 is partially enclosed with a heating element 52 (to be described below in more detail). Before moving the catheter, the tip is heated to soften it to make it easier to shape.

[0127] The catheter is caused to move in the Y direction, through the retaining (now acting as guiding) elements (30.1 , 30.2), towards the shaping elements (32.1 , 32.2, 32.3 and 32.4). Some of the shaping elements, being extendablepushing rods, may be extended (as illustrated in Figure 23) to engage the tip about a heated portion 64 to shape the tip.

[0128] Device 10.9, illustrated in Figures 24 to 27, is similar to device 10.8 in that tip 12 is partially enclosed with a heating element 52. This embodiment differs in the configuration and operation of the shaping element 32, which, instead of a series of pushing rods, is configured as a pulley element 64, which is left-right moving on a wire 66, behind the catheter, against the back surface 32. Extending from the pulley element in the Z direction is a pin 68.

[0129] This pin is retractable, allowing the pulley element to move behind the catheter without manipulating it. It is extendable to engage tip 14 to push it left or right to shape the tip, as illustrated in Figures 26 and 27.

[0130] Once the tip has been moved by the shaping elements of the device (of any of the embodiments above), and movement into, or maintenance of, that shape is assisted with the heating process described above, that shape has to be fixed or baked into the tip. This is achieved by cooling down the catheter below a material-specific temperature, which can be below the glass transition temperature, while holding the new shape, thus fixing the shape.

[0131] For a polymer catheter, curing with UV light can help set the tip shape. By directing UV light onto specific surfaces of the tip, those areas can be selectively stiffened, aiding in shape fixation. After shaping and cooling, UV light can be targeted to particular segments, increasing stiffness only where it is applied. Different light-source elements are activated based on the desired tip configuration, allowing selective stiffening of specific segments. Additionally, byadjusting exposure times, the stiffness of each segment can be precisely controlled.

[0132] This technique can be helpful for specific procedures and tip configurations. For example, it can be applied to stiffen the curve of the tip, helping it retain its shape during the insertion of stiff medical devices, such as folded stent grafts, through the catheter's lumen, or stiffen the distal portion of the tip, making it easier to catch the ostium of a vessel.

[0133] This stiffening, brought about by UV-light irradiation, increases the crosslinking between the molecular chains in the polymer, leading to increased stiffness. This is only possible with specific materials; usually, they would have cross-linking agents inside the material.

[0134] To achieve this, the device (of any of the embodiments above) 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 to fix the shape of the tip once the tip has been formed into shape.

[0135] Figures 9 and 10 depict one embodiment in which UV-emitting elements (54.1 , 54.2, ... , 54. N) are affixed to the inner surfaces of the walls (38.1 , 38.2, and 40). These elements can be activated independently and controlled by the control system to project UV radiation onto the surfaces of the tip facing the elements.

[0136] Regarding device 10.5, a plurality of heating (52.1 , 52.2, ... , 52. N) and UV emitting elements (54.1 , 54.2, ... , 54. N) are incorporated into the cylindrical retaining element 42, engaged to an inner surface to radiate energy onto the surfaces of the elements facing the tip. Therefore, by controlling which elementsare switched on, the operator can control which surface receives the energy and which surface is softened or stiffened to optimise the shape-forming and shapefixing process.

[0137] In a further embodiment 10.10, illustrated in Figure 28, the shapeforming elements 52.1 , 52.2,... ,52. N are IR-emitting elements affixed to the inner surfaces of the walls (38.1 , 38.2, and 40). These elements can be activated independently and controlled by the control system to project IR radiation onto the surfaces of the tip facing the elements.

[0138] Within the scope of the invention, it is anticipated that the shape-forming elements may include any source of electromagnetic radiation, not limited to IR radiation. For example, the emitters could be microwave emitters.

[0139] The advantage of using IR emitters to heat the catheter 14, rather than traditional heat-emitting elements, is that IR radiation can penetrate the transparent sterile barrier 70 of the sterile packaging wrapping the catheter. The IR radiation heats the catheter by being absorbed and converted into thermal energy by the catheter material.

[0140] Figure 29 illustrates device 10.11 , where the shape-forming elements are induction coils (respectively designated 52.1 , 52.2 and 52.3) generating a rapidly changing magnetic field as an AC passes through them. Inside the lumen of the catheter, wrapped with sterile packing 70, a metal wire filament 72.1 serves as the conductor. The magnetic field induces eddy currents in the filament, causing resistance and heating the filament, which then conductively heats the catheter wall.

[0141] As an alternative to the metal wire filament acting as a conductor, the metal braiding often included within the walls of a catheter provides structural reinforcement, flexibility and durability that can be used to heat the catheter inductively.

[0142] Figure 30 illustrates device 10.11 with the conductor as a hollow cylindrical foil wrap 72.2, partially enclosing the catheter. The foil is heated by induction, and this heat is transferred to the catheter walls.

Claims

CLAIMS1 . A device for shaping a tip of an endovascular catheter, which includes:(a) a housing which has a top wall, a bottom wall, a pair of sidewalls and a back wall,(b) a forming compartment within the housing, defined between an inner surface of the top wall, the bottom wall, the pair of sidewalls and the back wall, and which has an opening at a front side of the housing,(c) at least one shaping element engaged to at least the top wall, the bottom wall, a sidewall, or the back wall, which is actuatable to move a tip into a shape,(d) at least one retaining element within the compartment, which is adjustable to hold a catheter in a position to be engaged by the shaping elements, and(e) at least one shape-forming element within the compartment, which is actuatable to transfer energy to the tip section to form the shape of the tip.

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

3. The device according to claim 2 wherein the heating element may be radiant heating element.

4. The device according to claim 3 wherein the radiant heating element may be an infrared or microwave emitting element.

5. The device according to claims 3 or 4 wherein the radiant heating element is be mounted on a wall of the housing or integrated into the shaping element6. The device according to claim 2 wherein the heating element is an inductive heating element.

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

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

9. The device according to claim 7 or 8 wherein the conductor is a wrapper that partially encloses the catheter, a filament extending through the catheter, or structural braids integrated within walls of the catheter.

10. The device according to anyone of claims 1 to 9 which includes at least one shapefixing element within the compartment, which is actuatable to transfer energy to the tip to stiffen the tip.1 1. The device according to claim 10 wherein the shape-fixing element is a heating element or light-source.

12. The device according to claim 1 1 wherein the heating element is a radiant heating element.

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

14. The device according to anyone of claims 10 to 13 wherein the shape-fixing element is mounted to a wall of the housing or integrated into the shaping element.

15. The device according to anyone of claims 10 to 14 which includes a plurality of shape-fixing elements.

16. The device according to anyone of claims 1 to 15 wherein the at least one shaping element is an articulated arm which extends between a first and a second end, which is pivotally engaged to a wall at the first end to extend into the forming compartment, and which includes, at the second end, a holding element which is adapted to engage the tip, and which has at least one joint about which the arm articulates to move the tip.

17. The device according to claim 16 wherein the holding element comprises a pair of clamping elements which are actuated to move from an open position to allow placement of the tip to a closed position to enclose the tip.

18. The device according to claims 16 or 17 which includes a plurality of articulated arms, each independently actuatable to move the tip.

19. The device according to anyone of claims 1 to 15 which includes a plurality of shaping elements, each having an arc-shaped channel formed in the back wall and a sliding element engaged with the channel, independently actuatable to move along the channel and adapted to engage the tip.

20. The device according to anyone of claim 1 to 15 which includes a plurality of shaping elements, each comprising a tube formed in a wall of the housing and a rod mounted inside the tube, with the rods independently actuatable to extend from the tubes and engage a respective section of the tip.21 . The device according to anyone of claims 1 to 15 wherein the at least one shaping element includes a guide that at least partially extends between the sidewalls and a gliding element engaged to the guide, actuatable to move along the guide to contact the tip.

22. The device according to claim 21 wherein the gliding element is a retractable pin that is movable in a direction perpendicular to the back wall between a retracted and an extended position.

23. The device according to anyone of claims 16 to 22 which includes a control system to which each sliding element, rod or gliding element is electronically connected, wherein the control system is adapted to control the movement of each sliding element, rod or gliding element, in response to an input as to a desired shape of the tip.

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