Catheter shaft, reinforcements and manufacturing methods

Abstract

A medical catheter (100) and its manufacturing method are presented, creating a single device from two components. The catheter (100) features a proximal (104) and a distal shaft (106) with distinct polymeric material where the exposed braided structures are mechanically connected at a transition portion, resulting in a single shaft. A reinforcing assembly is integrated into the proximal shaft (104) and includes reinforcing sleeves with helical coils creating a steering wire guidance system, and a anchor ring mechanically connected to the transition portion. The distal shaft (106) incorporates an articulation structure with interconnected elements and steering wire lumens aligned with the reinforcing assembly. The manufacturing involves selectively removing polymeric jackets of a proximal (104) and distal shaft (106), exposing the braided structures, and mechanically connecting them. Such a catheter device (100) and manufacturing method addresses limitations of conventional joining methods, enhancing maneuverability and precision for navigating complex anatomies.

Description

NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01CATHETER SHAFT AND METHODS OF MAKING A CATHETER SHAFTCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 684,067, filed August 16, 2024, U.S. Provisional Patent Application No. 63 / 684,080, and U.S. Provisional Patent Application No. 63 / 684,101 , filed August 16, 2024, the disclosures of which are incorporated herein in their entireties.TECHNICAL FIELD

[0002] The present invention relates to medical devices and methods for catheters for medical procedures. More specifically, the invention relates to devices and methods that include structural and directional enhancements for catheters such as steerable catheters.BACKGROUND

[0003] Medical catheters incorporate flexible distal shafts for navigation as well as reinforced proximal shafts for pushability and torque response. However, joining proximal and distal catheter shafts of different materials and properties pose manufacturing challenges. Typical methods such as thermal bonding, adhesive bonding and reflowing proximal and distal shafts into an integrated device can be inconsistent and time intensive. In addition, the connection region between the joined proximal and distal shafts often exhibits abrupt mechanical property changes in stiffness and strength. These inefficiencies can impede positioning and performance capabilities of the catheter.

[0004] Therefore, there is a need for improved connection methods of integrating independent medical catheter shaft components into a single medical catheter device that enables greater catheter performance.SUMMARY

[0005] In Example 1 , a medical catheter comprising a handle configured for manipulation by a user, and a flexible shaft having a proximal portion, a distal portion, and a transition portion between the proximal and distal portions of the shaft. The proximal portion of the shaft extends distally from the handle and is formed from aNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 proximal shaft component having a proximal reinforcing braid and a proximal polymeric jacket disposed over the proximal reinforcing braid, wherein a first length of the proximal reinforcing braid extends distally of the proximal polymeric jacket. The distal portion of the shaft is formed from a distal shaft component having a distal reinforcing braid and a distal polymeric jacket disposed over the distal reinforcing braid, wherein a second length of the distal reinforcing braid extends proximally of the distal polymeric jacket and is mechanically connected to the first length of the proximal reinforcing braid. The transition portion of the shaft comprises the first length of the proximal braid member, the second length of the distal braid member, and a transition portion jacket disposed over the first length of the proximal braid member and the second length of the distal braid member.

[0006] In Example 2, the medical catheter of Example 1 , wherein the proximal portion comprises a reinforcing assembly disposed within the proximal shaft component. The reinforcing assembly comprises a pair of diametrically opposed helical reinforcing sleeves, wherein the reinforcing sleeves establish reinforced passageways configured to provide lateral support for one or more steering elements extending from the proximal region to the distal region, and an anchor ring attached to a distal end of each of the reinforcing sleeves, the anchor ring comprising a ring structure and including passageways for the one or more steering elements, and wherein the anchor ring is mechanically connected to the proximal shaft component and the distal shaft component in the transition portion.

[0007] In Example 3, the medical catheter of Example 2, wherein the distal portion comprises a deflectable region defining a longitudinal axis and further comprising an articulation structure disposed within the distal shaft component. The articulation structure comprises a plurality of longitudinally-arranged tubular segments and a plurality of connecting segments connecting adjacent tubular segments, one or more steering wire lumens extending through the tubular segments and aligned with the reinforcing sleeves, first and second reinforcing members extending through the tubular segments and the connecting segments.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0008] In Example 4, the medical catheter of Example 3, wherein the deflectable region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft.

[0009] In Example 5, the medical catheter of Example 3, wherein the one or more steering wire lumens are each circumferentially offset from the first and second reinforcing members by about 90 degrees.

[0010] In Example 6, the medical catheter of Example 2, wherein the first length of the proximal reinforcing braid and the second portion of the distal reinforcing braid overlap one another in the transition portion.

[0011] In Example 7, the medical catheter of Example 2, comprising a mechanical connection connecting the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

[0012] In Example 8, the medical catheter of Example 7, wherein the mechanical connection further connects the anchor ring to the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

[0013] In Example 9, the medical catheter of Example 7, wherein the transition portion jacket is formed from polymeric material reflowed over and around the mechanical connection connecting the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

[0014] In Example 10, the medical catheter of Example 9, wherein the mechanical connection is formed by at least one joining method including welding process, soldering process, adhesive process, polymer reflow process, or combination thereof.

[0015] In Example 11 , the medical catheter of Example 8, wherein the anchor ring includes a groove defined in its outer circumference, and wherein the mechanical connection is formed by disposing an adhesive material over the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid and into the groove.

[0016] In Example 12, the medical catheter of Example 8, wherein the mechanical connection comprises a weld joint connecting the first length of the proximal reinforcing braid, the second length of the distal reinforcing braid, and the anchor ring.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0017] In Example 13, the medical catheter of any of Examples 1 -12, wherein the proximal polymeric jacket and the distal polymeric jacket are made from different polymeric materials.

[0018] In Example 14, the medical catheter of any of Examples 1 -13, wherein the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid are dimensioned to define, in the absence of the transition portion jacket, a gap between the proximal polymeric jacket and the distal polymeric jacket having a length of about 0.030 inches to about 0.300 inches.

[0019] In Example 15, the medical catheter of Example 14, wherein the transition portion jacket fills and seals the gap.

[0020] In Example 16, a medical catheter comprising a handle configured for manipulation by a user, and a flexible shaft comprising a reinforcing braid and a polymeric jacket disposed over the reinforcing braid, the flexible shaft having a proximal portion, and a distal portion, the shaft further comprising a structural element is positioned within the shaft. The structural element is mechanically connected to the reinforcing braid at an attachment location via a mechanical connection establishing a secure bond between the reinforcing braid and the structural element, and the mechanical connection is formed by exposing the reinforcing braid by selective removal of the polymeric jacket material, and mechanically connecting the braid to the structural element.

[0021] In Example 17, the medical catheter of Example 16, wherein the structural element is configured to provide reinforcement to the flexible shaft or transmit forces along the flexible shaft.

[0022] In Example 18, the medical catheter of Example 16, wherein the mechanical connection comprises a welded connection between the reinforcing braid and the structural element.

[0023] In Example 19, the medical catheter of Example 1 , wherein the selective removal of the polymeric jacket is performed at any location along the length of the flexible shaft.

[0024] In Example 20, the medical catheter of Example 16, wherein the polymer jacket is removed to expose the reinforcing braid at one or more locations along theNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 flexible shaft, allowing for the mechanical connection of the structural element at each of the one or more locations.

[0025] In Example 21 , the medical catheter of Example 16, wherein the selective removal of the polymeric jacket is controlled to create a desired size and shape of exposure of the reinforcing braid.

[0026] In Example 22, the medical catheter of Example 16, wherein the structural element is a reinforcing assembly, wherein the reinforcing assembly is positioned within the proximal portion of the shaft, wherein the reinforcing assembly comprises a pair of diametrically opposed helical reinforcing sleeves extending through the proximal portion of the shaft, and an anchor ring attached to a distal end of the reinforcing sleeves, the anchor ring comprising a ring structure.

[0027] In Example 23, the medical catheter of Example 22, wherein the reinforcing sleeves establish reinforced passageways configured to provide radial and lateral support for one or more steering elements extending from the proximal region to the distal region.

[0028] In Example 24, the medical catheter of Example 22, wherein the anchor ring includes passageways for the one or more steering elements extending from the proximal region to the distal region.

[0029] In Example 25, the medical catheter of Example 24, wherein the anchor ring of the reinforcing assembly is positioned in close proximity to the attachment location.

[0030] In Example 26, the medical catheter of Example 25, wherein the anchor ring is connected through the mechanical connection to the reinforcing braid at the attachment location.

[0031] In Example 27, the medical catheter of Example 16, wherein the structural element is an articulation structure positioned within the distal portion of the shaft, the articulation structure having a proximal end, wherein the articulation structure comprises a plurality of longitudinally-arranged articulation elements, one or more steering wire lumens, wherein the steering wire lumens extend through the articulation structure, and one or more reinforcing members extending through the articulation elements.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0032] In Example 28, the medical catheter of Example 16, wherein the structural element is a single helical cable that comprises a proximal end and distal end, wherein the single helical cable extends longitudinally through the proximal shaft, and wherein the single helical cable provides structural support to the proximal shaft.

[0033] In Example 29, the medical catheter of Example 28, wherein the distal end of the single helical cable is positioned in close proximity to the attachment location.

[0034] In Example 30, the medical catheter of Example 29, wherein the distal end of the single helical cable is connected through the mechanical connection to the reinforcing braid at the attachment location.

[0035] In Example 31 , a medical catheter comprising a handle configured for manipulation by a user, and a flexible shaft comprising a reinforcing braid and a polymeric jacket disposed over the reinforcing braid, the flexible shaft having a proximal portion, and a distal portion, wherein a structural element is positioned within the shaft, wherein the structural element is mechanically connected to the polymeric jacket via a mechanical connection establishing a secure bond between the polymeric jacket and the structural element, and wherein the mechanical connection is formed by selectively removing a portion of the polymeric jacket to create a window exposing a portion of the reinforcing braid and disposing an attachment material through the window and the exposed portion of the reinforcing.

[0036] In Example 32, the medical catheter of Example 31 , wherein the structural element comprises a circumferential groove configured to receive the attachment material.

[0037] In Example 33, the medical catheter of Example 32, wherein the circumferential groove is formed on an outer surface of the structural element.

[0038] In Example 34, the medical catheter of Example 32, wherein the circumferential groove is positioned in close proximity to the window of the exposed reinforcing braid.

[0039] In Example 35, the medical catheter of Example 34, wherein the attachment material is disposed through the window of the exposed portion of the reinforcing braid into the groove of the structural element to establish the mechanical connection.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0040] In Example 36, the medical catheter of Example 35, wherein the attachment material is an adhesive, a polymeric material, or other similar bonding materials.

[0041] In Example 37, the medical catheter of Example 31 , wherein the selective removal of the polymeric jacket is controlled to create a desired size and shape of the window of the exposed reinforcing braid.

[0042] In Example 38, the medical catheter of Example 31 , wherein the structural element is a reinforcing assembly, wherein the reinforcing assembly is positioned within the proximal portion of the shaft, wherein the reinforcing assembly comprises a pair of diametrically opposed reinforcing sleeves extending through the proximal portion of the shaft, wherein the reinforcing sleeves establish passageways configured for one or more steering elements extending from the proximal region to the distal region of the shaft, and an anchor ring attached to a distal end of each of the reinforcing sleeves, the anchor ring comprising a ring having a groove defined around its circumference.

[0043] In Example 39, the medical catheter of Example 38, further comprising a pair of diametrically opposed steering elements each extending through a respective one of the reinforcing sleeves, wherein the reinforcing sleeves each provide radial and lateral support for the steering elements extending therethrough.

[0044] In Example 40, the medical catheter of Example 38, wherein the anchor ring includes a pair of diametrically opposed passageways aligned with the passageways of the reinforcing sleeves, and when each of the steering elements extends through a respective one of the passageways in the anchor ring.

[0045] In Example 41 , the medical catheter of Example 40, wherein the anchor ring of the reinforcing assembly is positioned in close proximity to the window of the exposed reinforcing braid.

[0046] In Example 42, the medical catheter of Example 41 , wherein the attachment material is disposed through the window of the exposed reinforcing braid into the groove of the anchor ring to establish the mechanical connection.

[0047] In Example 43, the medical catheter of Example 42, wherein the structural element is an articulation structure positioned within the distal portion of the shaft, the articulation structure having a proximal end, wherein the articulation structure comprisesNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 a plurality of longitudinally-arranged articulation elements, one or more steering wire lumens, wherein the steering wire lumens extend through the articulation structure, one or more reinforcing members extending through the articulation elements, and a circumferential groove formed on the proximal end of the articulation structure.

[0048] In Example 44, the medical catheter of Example 43, wherein the articulation elements comprise a plurality of tubular segments, a plurality of connecting segments, a plurality of articulation links, a plurality of joints, a plurality of reinforcing members, or combinations thereof.

[0049] In Example 45, the medical catheter of Example 44, wherein the attachment material is disposed through the window of the exposed reinforcing braid into the groove of the articulation structure to establish the mechanical connection.

[0050] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0051] FIG. 1 is an illustration of an example medical catheter, consistent with various aspects of the present disclosure.

[0052] FIG. 2A is an illustration of the medical catheter, shown in FIG. 1 , as deflected in a first direction, consistent with various aspects of the present disclosure.

[0053] FIG. 2B is an illustration of the medical catheter, shown in FIG. 1 , as deflected in a second direction, consistent with various aspects of the present disclosure.

[0054] FIG. 3 is a detailed illustration of a portion of a side-view illustration of the medical catheter, consistent with various aspects of the present disclosure.

[0055] FIG. 4A is an illustration of a reinforcing assembly enclosed in the medical catheter with a grooved anchor ring attachment, consistent with various aspects of the present disclosure.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0056] FIG. 4B is an illustration of a reinforcing assembly enclosed in the medical catheter with a smooth, non-grooved anchor ring attachment, consistent with various aspects of the present disclosure.

[0057] FIG. 5 is a top-view illustration of a reinforcing assembly of the medical catheter, consistent with various aspects of the present disclosure.

[0058] FIG. 6A is an illustration of an articulation structure and reinforcing assembly with a grooved anchor ring enclosed in the medical catheter, consistent with various aspects of the present disclosure.

[0059] FIG. 6B is an illustration of an articulation structure and reinforcing assembly with a non-grooved anchor ring enclosed in the medical catheter, consistent with various aspects of the present disclosure.

[0060] FIG. 7 is a detailed illustration of a portion of a side-view illustration of the medical catheter, consistent with various aspects of the present disclosure.

[0061] FIG. 8 is an illustration of a reinforcing assembly enclosed in the medical catheter with a anchor ring at an attachment location, consistent with various aspects of the present disclosure.

[0062] FIG. 9A is a top-view illustration of a reinforcing assembly of the medical catheter, consistent with various aspects of the present disclosure.

[0063] FIG. 9B is a partial isometric illustration of an alternative reinforcing assembly of the medical catheter, consistent with various aspects of the present disclosure.

[0064] FIG. 10A is an illustration of an articulation structure positioned at an attachment location and reinforcing assembly with a anchor ring positioned at another attachment location enclosed in the medical catheter, consistent with various aspects of the present disclosure.

[0065] FIG. 10B is an illustration of an articulation structure positioned at an attachment location and a single helical cable positioned at another attachment location enclosed in the medical catheter, consistent with various aspects of the present disclosure.

[0066] FIG. 11 is a detailed illustration of a portion of a side-view illustration of the medical catheter, consistent with various aspects of the present disclosure.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0067] FIG. 12A is an illustration of a reinforcing assembly enclosed in the medical catheter with a grooved anchor ring attachment, consistent with various aspects of the present disclosure.

[0068] FIG. 12B is an illustration of an articulation structure enclosed in the medical catheter with a circumferential groove formed on its proximal end, consistent with various aspects of the present disclosure.

[0069] FIG. 13 is a top-view illustration of a reinforcing assembly of the medical catheter, consistent with various aspects of the present disclosure.

[0070] FIG. 14 is an illustration of an articulation structure with a circumferential groove on its proximal end and reinforcing assembly with a grooved anchor ring enclosed in the medical catheter, consistent with various aspects of the present disclosure.

[0071] While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.DETAILED DESCRIPTION

[0072] For purposes of promoting an understanding of the principles of the present disclosure, reference is now made to the examples illustrated in the drawings, which are described below. The illustrated examples disclosed herein are not intended to be exhaustive or to limit the disclosure to the precise form disclosed in the following detailed description. Rather, these exemplary embodiments were chosen and described so that others skilled in the art may use their teachings. It is not beyond the scope of this disclosure to have a number (e.g., all) the features in a given example used across all examples. Thus, no one figure should be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, various components depicted in a given figure may be, in examples, integrated with various ones of the other components depicted thereinNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01(and / or components not illustrated), all of which are considered to be within the ambit of the present disclosure.

[0073] FIG. 1 , FIG. 2A and FIG 2B are illustrations of an example medical catheter 100, consistent with various aspects of the present disclosure. As shown in FIG. 1 , the medical catheter 100 may be a steerable medical catheter 100. In certain instances, the medical catheter 100 is steerable in one direction (e.g., direction A as shown in FIG. 2A) or in another direction (e.g., direction B as shown in FIG. 2B). The medical catheter 100 generally includes a tubular shaft 102 having a proximal portion 104 and a distal portion 106 that is sized and configured for placement and manipulation within in a target area of a patient. The distal portion 106 may be steerable. As shown, the distal portion 106 further includes a deflection region 108 and a distal end 110.

[0074] In certain instances, the tubular shaft 102 extends from a distal portion of a handle 112. An electrical cable or other suitable connector 114 extending from a proximal end of the handle 112 may be coupled to a source of energy or other equipment (not shown in FIG. 1 ) for transmitting one or more ablation signals. A steering actuator 116, such as a rotatable knob or plunger that may be arranged at the handle 112, may be manipulated by a physician to deflect or position the steerable distal portion 106 of the tubular shaft 102.

[0075] As shown in FIGS. 2A and 2B, the medical catheter 100 is of the deflectable or steerable type, such that during use, the deflection region 108 can be deflected or curved by a user to facilitate locating the distal end 110 at a desired target location within the heart. In embodiments, deflection of the deflection region 108 can be accomplished by manipulation of the steering actuator 118, which is operatively connected to steering elements (e.g., wires, tendons, ribbons, and the like) extending within and attached (directly or indirectly) to the shaft 102 at a location within the distal portion 106. The particular mode and structure for deflecting the deflection region 108 is not critical to the present disclosure, and so any technique, whether now known or later developed, can be employed within the scope of the present disclosure.

[0076] In use, deflecting or curving the distal portion 106 may impart a torsional force that could torque or twist the distal portion 106 away from or out of the targetNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 location. The deflection region 108 may torque out of plane from the plane in which the distal portion 106 was arranged prior to deflection due to the tension on the curvature of the medical catheter 100 within vasculature.

[0077] FIG. 3 is an enlarged detail view (see FIG. 2B, “Detail ‘X’”) of the medical catheter 100 illustrating a mechanical connection 202 of the proximal shaft 104 and the distal shaft 106 creating a transition portion 200. As shown, shaft 102 includes proximal polymeric jacket 208 encapsulating the proximal portion of the shaft 104, and a distal polymeric jacket 206 encapsulating the distal portion of the shaft 106. In certain instances, the proximal portion 104 and the distal portion 106 may be constructed of different materials to impart specific performance characteristics. For example, the proximal polymeric jacket 208 and the distal polymeric jacket 206 may be of a braided construction, wherein the proximal polymeric jacket 208 and the distal polymeric jacket 206 each having a polymer material reinforced with a distinct reinforcing braid formed of a plurality of interwoven wires that are woven, knitted, entwined or otherwise interlaced together.

[0078] As shown in FIG. 3, the shaft 102 includes a proximal polymeric jacket 208 encapsulating the proximal portion 104, and a distal polymeric jacket 206 encapsulating the distal portion 106. To integrate the proximal portion 104 and the distal portion 106 into a unified device, a user may strategically remove the polymeric jacket 360 degree around the adjoining ends of the proximal and distal shaft portions, through a removal process (e.g. ablation process or other removal process), to expose underlying reinforcing braids. The proximal polymeric jacket 208 may be removed from a terminal segment of the proximal portion 104, revealing an extending length of proximal reinforcing braid 204. Similarly, the distal polymeric jacket 206 may be removed from the adjoining end of the distal portion 106, exposing a length of distal reinforcing braid 210. The exposed braids 204, 210 originate from independent spools within their respective shaft jackets. The exposed proximal reinforcing braid 204 and distal reinforcing braid 206 may be mechanically connected to create the transition portion 200 of the shaft 102 through the mechanical connection 202 wherein the transition portion 200 may create a braided gap 212 between the proximal portion 104 and the distal portion 106. In various embodiments, the braided gap 212 may have aNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 length of about 0.030 inches to about 0.300 inches. The mechanical connection 202 may provide several advantages in allowing for a gradual transition of mechanical properties, such as flexibility and torque response, between the disparate proximal and distal shaft materials. The mechanical connection allows the integrated medical catheter 100 maneuverability and overall performance of the catheter. Additionally, in some embodiments, a user may make modifications after the mechanical connection is accomplished, such as further material encapsulation, to fine-tune catheter performance.

[0079] In some embodiments, the mechanical connection 202 may be done through welding process, soldering process, adhesive process, polymer reflow process, or other processes that may enhance the connection between the proximal reinforcing braid 204 and the distal reinforcing braid 210.

[0080] In some embodiment, polymeric material may be reflowed over and around the mechanically connected reinforcing braids 204, 210 to seal and encapsulate the mechanically connected components into a polymeric jacket, wherein the reflowed polymeric material is from the existing polymeric jacket or a polymeric material same composition as the existing polymeric jacket or a compatible material.

[0081] Referring now to FIG. 4A and FIG. 4B, a reinforcing assembly 300 is introduced within the medical catheter 100. The reinforcing assembly 300, is a component within the medical catheter that facilitates steering control and maneuverability with the integration of reinforcing sleeves 302 which may act as a reinforced steering wire guidance system within the catheter shaft, allowing for controlled deflection of the distal portion 106 while providing support and stability to the proximal portion 104. The reinforcing assembly 300 is positioned within the proximal portion 104 of the medical catheter shaft 102 and extends into the distal portion 106 and comprises reinforcing sleeves 302 and an anchor ring (304 or 310), wherein the anchor ring may be composed from a metallic material or of a similar alloy. The reinforcing sleeves 302 may comprise a pair of diametrically opposed helical coils that extends longitudinally through the proximal portion 104 of the shaft 102. Further, the reinforcing sleeves 302 create dedicated passageways for one or more steering elements (e.g., wires, tendons, ribbons, and the like) 306, wherein the one or more steering elementNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 may comprise a first steering element 306a and a second steering element 306b. The one or more steering elements 306 are located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner. Additionally, the reinforcing sleeves 302 may provide radial and lateral support and guidance for the one or more steering elements 306 by encasing them within the helical coils. The protective structure may help minimize the impact of any compressive or any other forces that may occur during catheter manipulation allowing the steering elements to maintain their integrity and functionally for consistent and precise deflection of the deflection region 108.

[0082] Further, at a distal end of the reinforcing assembly 308, the reinforcing sleeves 302 are securely attached to the anchor ring (304 or 310) positioned near or at the transition portion 200 serving as an anchoring point, wherein the anchor ring (304 or 310) includes passageways for the one or more steering elements 306 extending from the proximal region to the distal region. In an example embodiment, the anchor ring is illustrated with a grooved anchor ring 304 (FIG. 4A). In another embodiment the anchor ring is shown with a smooth, non-grooved anchor ring 310 (FIG. 4B). The grooved anchor ring 304 of FIG. 4A features a circumferential groove 309, wherein the circumferential groove may accommodate an adhesive. The circumferential groove 309 allows an adhesive to fill the space, creating a connection between the anchor ring 304 and the transition portion 200. The adhesive may flow through the braided gap 212 and flow into the groove, filling the voids and forming a strong bond that prevents slippage and maintains the integrity of the reinforcing assembly 300. The secure attachment allows for a seamless transfer of steering forces from the proximal portion 104 to the distal portion 106, allowing control and maneuverability of the medical catheter 100.

[0083] In some embodiment, the anchor ring 304 may be mechanically connected through welding process, soldering process, adhesive process, polymer reflow process, or other processes that may enhance the connection between the anchor ring 304 and the transition portion 200.

[0084] In some embodiment, polymeric material may be reflowed over and around the mechanically connected reinforcing braids 204, 210 and the anchor ring 304NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 to seal and encapsulate the mechanically connected components into a polymeric jacket.

[0085] In contrast, FIG. 4B illustrates the smooth, non-grooved anchor ring 310. While lacking the circumferential groove, the smooth anchor ring 310 may still be effectively attached to the transition portion 200 using suitable mechanical means of connection. These means of mechanical connection may be done through welding process, soldering process, adhesive process, polymer reflow process, or other processes that may allow the connection between the anchor ring 310 and the transition portion 200. The choice between a grooved anchor ring 304 and the smooth anchor ring 310 may depend on various factors, including the desired level of attachment strength, manufacturing feasibility, and specific requirements of the medical catheter application.

[0086] In some embodiment, polymeric material may be reflowed over and around the mechanically connected reinforcing braids 204, 210 and the anchor ring 310 to seal and encapsulate the mechanically connected components into a polymeric jacket.

[0087] Regardless of the anchor ring design, the strategic positioning and mechanical attachment of the anchor ring (304 or 310) to the transition portion 200 allows transfer of steering forces from the proximal portion 104 to the distal portion 106. The mechanical connection may help with overall control and maneuverability of the medical catheter 100 enabling precise navigation through challenging anatomical structures.

[0088] In some embodiments, the reinforcing assembly 300 may be adapted to suit specific catheter designs and applications. Variations in the number, configuration, and / or material composition of the reinforcing sleeves 302 and anchor rings (304 or 310) may be employed to optimize performance characteristics. For example, the helical coils of the reinforcing sleeves may be designed with different diameters, or the anchor rings may be constructed of various materials to achieve the desired strength, and flexibility.

[0089] FIG. 5A is a top view illustration of the reinforcing assembly 300 as previously described in FIG. 4A and FIG. 4B. As shown, the reinforcing assembly includes the reinforcing sleeves 302 wherein the reinforcing sleeves 302 createNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 dedicated passageways 320, 322 for the one or more steering elements 306. The one or more steering elements 306 may be located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner.

[0090] FIG. 6A and FIG. 6B introduces the articulation structure 400 that may be positioned within the distal portion of the medical catheter shaft 102 and facilitates predictable, highly planar deflection of the deflection region 108 by resisting torsional forces on the shaft 102 that would otherwise tend to cause the deflection region 108 to deflect. The articulation structure 400 may comprise series of interconnected plurality of longitudinally-arranged articulation elements that work together to achieve the desired deflection characteristics. These articulation elements may comprise a plurality of longitudinally arranged tubular segments, a plurality of connecting segments, plurality of articulation links, a plurality of joints, a plurality of reinforcing members, or combinations thereof. In the illustrated embodiment, the articulation structure includes a plurality ot tubular segments 402 and a plurality of connecting segments 404 connecting adjacent tubular segments 402. The articulation structure 400 may include one or more reinforcing members (not shown) embedded within the articulation elements and extending through the articulation structure 400 wherein the reinforcing members may maintain a curved shape of the deflection region 108 during deflection and maintain repeatability of achieving the curved shape of the deflection region 108 during deflection. In an example embodiment the one or more reinforcing members may comprise a helically wound flat ribbon wire or stranded wire cables or of similar elements. The articulation structure 400 may further comprise one or more steering wire lumens arranged in parallel to the passageways 320, 322 of the reinforcing assembly 300 wherein the steering wire lumens may be configured to receive one or more steering elements 306 that are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner. The one or more steering wire lumens may also be circumferentially offset from the one or more reinforcing members by about 90 degrees. The specific design and arrangement of these elements can vary dependingNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 on the desired deflection profile and the intended application of the medical catheter 100. As shown, the articulation structure 400 may be positioned in close proximity to the reinforcing assembly 300 wherein the distal end of the reinforcing assembly 308 is touching or near the proximal end of the articulation structure 404. This placement allows transfer of steering forces from the reinforcing assembly 300 to the articulation structure 400, allowing smooth and controlled deflection of the distal portion of the medical catheter shaft 102. In response to a deflection force, the articulation structure 400 may bend in a direction A (FIG.2A). In certain embodiments, the articulation structure 400 may bend in another direction B (FIG. 2B), opposite to that of direction A. Whether the articulation structure 400 is unidirectional or bidirectional is not of critical importance to the current invention.

[0091] The articulation structure 400 being arranged within the deflection region 108 of the tubular shaft 102 operates to stabilize at least the distal portion 106 of the tubular shaft 102. In other instances, the articulation structure 400 may extend along a length of the tubular shaft 102 or extend into an intermediate section between the proximal portion 104 and the distal portion 106.

[0092] The articulation structure 400 embedded within the deflection region 108 of the tubular shaft 102 may be caused to assume a curved shape when the tubular shaft 102 is arranged within a patient’s vasculature. The ability to selectively curve the deflection region 108 can facilitate accurate and effective delivery therapy (e.g., ablation) or map the surface of the heart tissue (e.g., identify the locations of heart tissue that are a source of the arrhythmias).

[0093] In some embodiments, the articulation structure 400 may include a center lumen wherein the center lumen may include components such as one or more wires for ablation electrodes arranged along the shaft 102, navigational components, a temperature sensor (e.g., thermocouple), a force sensor, radio-frequency circuitry and / or wires, and a cooling lumen. The center lumen may be a working channel through which one or more devices may be passed.

[0094] FIG. 7 is an enlarged detail view (see FIG. 2B, “Detail ‘X”’) of an alternative embodiment of the medical catheter 100 of FIG. 1 illustrating an attachment location 1200 on the catheter shaft 102. The catheter shaft 102 is composed of aNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 reinforcing braid 1205 and a polymeric jacket 1210 disposed over the reinforcing braid 1205, wherein the reinforcing braid 1205 is formed of a plurality of interwoven wires that are woven, knitted, entwined or otherwise interlaced together. The skilled artisan will recognize that the use of jackets in catheter construction is well known, and the particular details of the braid / jacket construction are not of critical importance to the present disclosure. In embodiments, the aforementioned braid can be omitted, or alternatively, other constructions, e.g., reinforcing coils, can be employed to enhance the structural and torsional strength of the jacket.

[0095] As shown, the selective removal of the polymeric jacket at any location along the length of the shaft to expose the underlying reinforcing braid 1205, allows a user flexibility to connect a structural element that is positioned within the shaft through the exposed braid at the attachment location 12OO.This removal process may be done by laser ablation wherein a user may strategically remove the polymeric jacket 1210 around the circumference of the shaft 102 to expose the underlying reinforcing braid 1205. The length, width, and depth of the exposed portion of the reinforcing braid 1205 may be tailored to a desired size to accommodate the integration of different structural elements. In some instances, the removal of the polymeric jacket 1210 may create an exposed braid groove 1212 at the attachment location 1200 of the shaft 102. The selective removal of the polymeric jacket 1210 may also create a braided gap 1203 between the remaining portions of the polymeric jacket 1210 wherein the length of the braided gap 1203 may be controlled by the removal process. In various embodiments, the braided gap 1203 may have a length of about 0.020 inches to 0.015 inches.

[0096] The selective removal of polymeric material of the polymeric jacket 1210 exposes the underlying reinforcing braid 205 providing access to allow the integration of structural elements by a mechanical connection to the reinforcing braid 1205 at the attachment location 1200. The internal structural elements may comprise a reinforcing assembly, an articulation structure, or of similar structural elements. The mechanical connection to integrate the structural element to the reinforcing braid 1205 may be done through a welding process, soldering process, adhesive process, polymer reflow process, or other processes that may enhance the connection between the structural element and the reinforcing braid 1205 at the attachment location. In some instances,NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 the existing polymeric jacket 1210 may be reflowed over the exposed braid groove 1212 and the braid gap 1203 to seal and encapsulated the attachment location 1200. The reflowed polymeric material from the existing polymeric jacket 1210 forms a smooth, continuous surface over the exposed reinforcing braid 1204 and the integrated structural elements.

[0097] In some cases, if the braided gap 1203 is too wide, the existing polymeric jacket 1210 may not provide sufficient material to completely cover the exposed reinforcing braid 1205 when reflowed. In such instances, additional polymeric material may need to be added to the reflowed polymeric jacket 1210 to ensure complete coverage and sealing of the attachment location 1200. The additional polymeric material may be of the same composition as the existing polymeric jacket 1210 or a compatible material.

[0098] In some embodiments, a user may strategically remove the polymeric jacket 1210 partially or fully by laser ablation or of similar removal process such that the length, width, and depth of the exposed portion of the reinforcing braid 1205 may be tailored to a desired size to accommodate integration of different structural elements to the shaft.

[0099] In some embodiments, the removal process may involve mechanical cutting, chemical etching, thermal ablation, and other suitable removal processes.

[0100] In some embodiments, creation of one or more exposed portion of the reinforcing braid 1205 along the catheter shaft 102 may be formed to allow a user access to mechanically connect the structural element or various structural elements at various attachment locations.

[0101] Referring now to FIG. 8, as well as FIG. 1 and 7, a reinforcing assembly 1300 is introduced within the medical catheter 100, wherein the selective removal of portions of the polymeric jacket 1210 and mechanical connection 1202 of the reinforcing assembly 1300 is performed at the attachment location 1200. The reinforcing assembly 1300, is a structural element within the medical catheter that facilitates steering control and maneuverability with the integration of reinforcing sleeves 1302 which may act as a reinforced steering wire guidance system within the catheter shaft, allowing for controlled deflection of the distal portion 106 while providing support and stability to theNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 proximal portion 104. The reinforcing assembly 1300 is positioned within the proximal portion 104 of the medical catheter shaft 102 and extends into the distal portion 106 and comprises reinforcing sleeves 1302 and an anchor ring 1304, wherein the anchor ring 1304 may be composed from a metallic material or of a similar alloy. The reinforcing sleeves 1302 may comprise a pair of diametrically opposed helical coils that extends longitudinally through the proximal portion 104 of the shaft 102. Further, the reinforcing sleeves 1302 create dedicated passageways for one or more steering elements (e.g., wires, tendons, ribbons, and the like) 1306, wherein the one or more steering element may comprise a first steering element 1306a and a second steering element 1306b. The one or more steering elements 1306 are located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the shaft 102 as known in the conventional manner. Additionally, the reinforcing sleeves 1302 may provide radial and lateral support and guidance for the one or more steering elements 1306 by encasing them within the helical coils. The protective structure may help minimize the impact of any compressive or any other forces that may occur during catheter manipulation allowing the steering elements to maintain their integrity and functionally for consistent and precise deflection of the deflection region 108.

[0102] Further, at a distal end of the reinforcing assembly 1308, the reinforcing sleeves 1302 are securely attached to the anchor ring 1304, wherein the anchor ring 1304 includes passageways for the one or more steering elements 1306 extending from the proximal region to the distal region. The anchor ring is shown with a smooth, nongrooved anchor ring 1304, wherein the anchor ring may be positioned underneath and at center of, or in close proximity to the attachment location 1200 of the catheter shaft 102 serving as an anchoring point. The anchor ring 1304 may be connected to the reinforcing braid 1205 at the attachment location 1200 by the mechanical connection 1202. The mechanical connection may be done through a welding process, soldering process, adhesive process, polymer reflow process, or other processes that may allow and enhance the connection between the anchor ring 1304 and the exposed underlying reinforcing braid 1205. In some instances, the existing polymeric jacket 210 may be reflowed over the exposed braid groove 1212 and the braid gap 1203 to seal andNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 encapsulate the attachment location 1200. The secure attachment of the anchor ring to the exposed reinforcing braid allows for a seamless transfer of steering forces from the proximal portion 104 to the distal portion 106, allowing control and maneuverability of the medical catheter 100.

[0103] In an example embodiment, the anchor ring may be illustrated with a grooved anchor ring. The grooved anchor ring may feature a circumferential groove, wherein the circumferential groove may accommodate an adhesive. The circumferential groove allows an adhesive to fill the space, creating a connection between the anchor ring and the reinforcing braid 1205 at the attachment location 1200. The adhesive may flow through the braided gap 1203 and flow into the groove, filling the voids and forming a strong bond that prevents slippage and maintains the integrity of the reinforcing assembly 1300. Further, in some instances, the existing polymeric jacket 1210 may be reflowed over the braid gap 1203 and exposed braid groove 1212 to seal and encapsulate the attachment location 1200. The choice between a grooved anchor ring and the smooth anchor ring 1304 (FIG. 4) may depend on various factors, including the desired level of attachment strength, manufacturing feasibility, and specific requirements of the medical catheter application.

[0104] The strategic positioning and mechanical connection of the anchor ring 1304 to the reinforcing braid 1205 at the attachment location 1200 allows transfer of steering forces from the proximal portion 104 to the distal portion 106. The mechanical connection may help with overall control and maneuverability of the medical catheter 100 while maintaining a smooth transition between the proximal portion and distal portion without compromising the catheter's flexibility or introducing abrupt changes in stiffness enabling precise navigation through challenging anatomical structures.

[0105] In some embodiments, the reinforcing assembly 1300 may be adapted to suit specific catheter designs and applications. Variations in the number, configuration, and / or material composition of the reinforcing sleeves 1302 and anchor ring 1304 may be employed to optimize performance characteristics. For example, the helical coils of the reinforcing sleeves may be designed with different diameters and materials, or the anchor ring may be constructed of various materials to achieve the desired strength, and flexibility.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01

[0106] FIG. 9A is a top view illustration of the reinforcing assembly 300 as previously described in FIG. 8. As shown, the reinforcing assembly includes the reinforcing sleeves 1302 wherein the reinforcing sleeves 1302 create dedicated passageways 1320, 1322 for the one or more steering elements 1306. The one or more steering elements 1306 may be located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner.

[0107] FIG. 9B is a partial isometric illustration of an alternative reinforcing assembly 1350, according to various embodiments. As shown, the reinforcing assembly 1350 includes a pair of coiled proximal reinforcing sleeves 1352, a pair of coiled distal reinforcing sleeves 1354, and an anchor ring 1360 disposed therebetween. In the illustrated embodiment, the proximal reinforcing sleeves 1352 have a relatively tight, or even close, pitch, and can correspond functionally and structurally to the reinforcing sleeves 1302 described above. Additionally, the anchor ring 1360 corresponds to the anchor ring 1202 described above. As further shown, the distal pair of reinforcing sleeves 1354 are attached at their proximal ends to and extend distally from the anchor ring 1360. Each of the reinforcing sleeves 1352 is axially aligned with one of the reinforcing sleeves 1354 across the anchor ring 1360 so as to form a continuous axial passage for slidably receiving a steering element as described above. In embodiments, an additional anchor ring may be attached to the distal ends of the pair of distal reinforcing sleeves 1354 to maintain their special relationship and to facilitate attachment to the catheter shaft. In other embodiments, the distal reinforcing sleeves may be incorporated into an articulation element (e.g, the articulation structure 1400 described below in conjunction with FIGS. 10A and 10B).

[0108] FIG. 10A and FIG. 10B introduces the creation of multiple attachment locations 1200a and 1200b along the catheter shaft 102 to allow for mechanical connection of various structural elements. This approach allows for the integration of structural elements such as the reinforcing assembly 1300 and an articulation structure 1400, which may contribute to the overall steering performance and stability of the catheter 100 (FIG. 1 ). The process may involve selectively removing portions of theNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 polymeric jacket 1210 at specific locations along the catheter shaft 102 to exposing reinforcing braids 1205 at multiple attachment locations 1200a and 1200b, wherein the exposing of the reinforcing braids may create an exposed braid groove 1212 and a braided gap 1203.

[0109] Referring collectively to FIGS. 1 , 7, 8 and 10A, as shown, the reinforcing assembly 1300 is positioned such that the anchor ring 1304 sits underneath and at center of, or in close proximity to the first attachment location 1200a. The anchor ring 1304 may be connected by a first mechanical connection 1202a to the reinforcing braid 205 at attachment location 1200a securing the anchor ring 1304 and the reinforcing assembly 1300 to the catheter shaft 102. Similarly, the articulation structure 1400 may be positioned within the distal portion of the shaft 106 a proximal end of the articulation structure 1404 sits underneath and at center of, or in close proximity to the second attachment location 1200b. The articulation structure 1400 may be connected by a second mechanical connection 1202b to the reinforcing braid 1205 at attachment location 1200b securing the articulation structure 1400 to the catheter shaft 1102. The mechanical connections 1202a and 1202b may be done through a welding process, soldering process, adhesive process, polymer reflow process, or other processes that may enhance the connection of the articulation structure and the reinforcing assembly to the reinforcing braids at the attachment locations 1200a and 1200b. In some instances, the existing polymeric jacket 1210 may be reflowed over the exposed braid groove 1212 and the braid gap 1203 to seal and encapsulated the attachment locations 1200a and 1200b. The reflowed polymeric material from the existing polymeric jacket 1210 forms a smooth, continuous surface over the exposed material without compromising the catheter's flexibility or introducing abrupt changes in stiffness.

[0110] FIG. 10B illustrates an alternative embodiment, wherein a single helical cable 340 is positioned within the proximal portion of the catheter shaft. Referring collectively to FIGS. 1 , 7, 8 and 10B, the single helical cable 1340 extends longitudinally through the proximal portion 104 providing structural support or other functional and performance enhancements to the medical catheter 100. The distal end 1330 of the single helical cable is positioned at center of, or in close proximity to the first attachment location 1200a and connected to the exposed reinforcing braid 1205 by the firstNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 mechanical connection 1202a, securing the single helical cable 340 to the catheter shaft 1102. The articulation structure 1400 is positioned and connected to the second attachment location 1202b in a similar manner as described in FIG. 10A. The proximal end of the articulation structure 1404 sits underneath and at center of, or in close proximity to the second attachment location 1200b. The articulation structure 1400 may be connected by a second mechanical connection 1202b to the reinforcing braid 1205 at attachment location 1200b securing the articulation structure 1400 to the catheter shaft 102.

[0111] In some embodiments, the single helical cable 1340 may have a ring structure attached its distal end 1330. The ring structure may be similar to that of the anchor ring 1304 described in FIG. 10A. The ring structure of the single helical cable may be positioned such that the ring sits underneath and at center of, or in close proximity to the first attachment location 1200a. The ring of the single helical cable may be connected by a first mechanical connection 1202a to the reinforcing braid 1205 at attachment location 1200a securing the ring structure and the single helical cable 1340 to the catheter shaft 102. In some embodiments, the single helical cable 1340 may be designed with different diameters and materials to achieve the desired strength, and flexibility in the catheter shaft.

[0112] In some embodiments, the proximal end of the articulation structure as shown in FIGS. 10A and 10B may include a metallic component or of similar alloy, such as a ring or collar, designed to support the articulation structure and allow for mechanical connection to the exposed braid at the attachment location. This metallic component may facilitate a smooth mechanical connection and provide additional strength and durability to the connection, allowing a stable integration of the articulation structure with the catheter shaft.

[0113] Further, the articulation structure 1400 of FIGS. 10A and 10B facilitates predictable, highly planar deflection of the deflection region 108 by resisting torsional forces on the shaft 102 that would otherwise tend to cause the deflection region 108 to deflect. The articulation structure 1400 may comprise series of interconnected plurality of longitudinally-arranged articulation elements that work together to achieve the desired deflection characteristics. These articulation elements may comprise a pluralityNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 of longitudinally arranged tubular segments, a plurality of connecting segments, plurality of articulation links, a plurality of joints, a plurality of reinforcing members, or combinations thereof. The articulation structure 1400 may include one or more reinforcing members embedded within the articulation elements and extending through the articulation structure 1400 wherein the reinforcing members may maintain a curved shape of the deflection region 108 during deflection and maintain repeatability of achieving the curved shape of the deflection region 108 during deflection. In an example embodiment the one or more reinforcing members may comprise a helically wound flat ribbon wire or stranded wire cables or of similar elements.

[0114] The articulation structure 1400 may further comprise one or more steering wire lumens arranged in parallel to the passageways 1320, 1322 of the reinforcing assembly 1300 in FIG. 10A and parallel to the single helical cable 1325 in FIG. 10B, wherein the steering wire lumens may be configured to receive one or more steering elements 1306 that are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner. The one or more steering wire lumens may also be circumferentially offset from the one or more reinforcing members by about 90 degrees. The specific design and arrangement of these elements can vary depending on the desired deflection profile and the intended application of the medical catheter 100.

[0115] As shown, the articulation structure 1400 may be positioned in close proximity to the reinforcing assembly 1300 or the single helical cable 1340. This placement allows transfer of steering forces from the reinforcing assembly 1300 or the single helical cable 1340 to the articulation structure 1400, allowing smooth and controlled deflection of the distal portion. In response to a deflection force, the articulation structure 1400 may bend in a direction A (FIG.2A). In certain embodiments, the articulation structure 1400 may bend in another direction B (FIG. 2B), opposite to that of direction A. Whether the articulation structure 1400 is unidirectional or bidirectional is not of critical importance to the current invention.

[0116] The positioning of the attachment locations 1200a and 1200b, along with the placement of the reinforcing assembly 1300, single helical cable 1340, and articulation structure 1400, can be tailored based on the specific design requirements ofNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 the catheter 100. Factors such as the desired deflection profile, the length of the distal portion 106, and the overall catheter stiffness can influence the optimal placement of these components. In some embodiments, additional attachment locations 1200 may be created to accommodate mechanical connection to other structural elements or to provide multiple points for mechanical connection to a single structural element. As such, a user may strategically remove the polymeric material partially or fully by laser ablation or of similar removal process such that length, width, and depth of the exposed portion of the reinforcing braid 1205 may be tailored to a desired size accommodate the integration of different structural elements to the shaft. Moreover, the pattern and arrangement of the exposed reinforcing braids 1205 can be modified to achieve specific performance characteristics. For example, helical or staggered arrangements of the exposed reinforcing braids 1205 could be utilized to optimize the flexibility and torsional rigidity of the catheter shaft 1102 in specific region to allow for the secure integration of structural elements at multiple attachment locations while maintaining a smooth, continuous profile along the catheter shaft 102 contributing to the overall performance, maneuverability, and stability of the steerable medical catheter 100.

[0117] FIG. 11 is an enlarged detail view (see FIG. 2B, “Detail ‘X’”) of the medical catheter 100 (see FIG. 1 ) according to another embodiment of the present disclosure. Referring to FIGS. 1 and 11 , in the illustrated embodiment, the catheter shaft 102 comprises a polymeric jacket 2210 that surrounds and encapsulates the shaft 102, wherein the polymeric jacket 2210 is composed of a polymeric material and includes an embedded reinforcing braid 2205 formed of a plurality of interwoven wires that are woven, knitted, entwined or otherwise interlaced together. FIG. 11 illustrates the removed a portion of the polymeric jacket 2210 to create a window 2200 of the exposed reinforcing braid 2205 on the catheter shaft 102. The window 2200 of the exposed reinforcing braid 2205 is created through a selective removal process wherein the removal process can be achieved through various processes, such as laser ablation, mechanical cutting, chemical etching, or thermal ablation. By carefully controlling the depth, shape, and size of the removal process, the window 2200 of the exposed reinforcing braid 2205 can be tailored to a desired dimension and can be formed at any location along the catheter shaft 102. In various embodiments, the size of the windowNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO012200 of the exposed reinforcing braid may be varied based on various factors relating to the structural characteristics and requirements of the catheter shaft 102, the manufacturing equipment and processes employed, and the like. In embodiments, the window 2200 may be generally rectangular in shape, and have minimum dimensions of about 0.020 inches by 0.020 inches, or alternatively in embodiments, the window 2200 may have a non-rectangular shape (e.g., circular, elliptical) with a minimum exposed braid area comparable to the aforementioned rectangular window 200.

[0118] In the illustrated embodiment, laser ablation is used to remove sections of the polymeric jacket 2210 in a precise and controlled manner. The laser ablation parameters, such as wavelength, power, pulse duration, spot size, or other parameters are selected to effectively remove the polymeric material without causing damage to the underlying reinforcing braid 2205. The laser is guided along the surface of the catheter shaft 102 to create the window 2200 of the reinforcing braid 2205. In some embodiments, the laser may create the window 2200 of the reinforcing braid 2205 with well-defined edges and a predetermined shape, such as a circle, oval, square, rectangle or other shapes.

[0119] The location and arrangement of the window 2200 can be tailored to accommodate the specific structural elements that may be mechanically connected with the polymeric jacket 2210. In the present disclosure, the window 2200 of the exposed reinforcing braid 2205 are strategically positioned to align with circumferential grooves formed on the outer surfaces of structural elements, such as a reinforcing assembly or an articulation structure. A mechanical connection 2202 (connection show in later figures) may be established between the structural elements and the polymeric jacket 2210 by introducing an attachment material such as an adhesive, polymeric material, or similar bonding materials through the window 2200 of the exposed braids 2205 into the circumferential grooves. The attachment material is flowed through the window 2200 to fill the space of the circumferential groove, until the voids or gaps of the groove are filled. As the attachment material fills the groove, it creates a direct contact between the structural element and the polymeric jacket 2210. This direct contact allows the attachment material to adhere to both the structural element and the braid 2205, effectively locking the structural element in place and creating a strong bond betweenNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 the structural element and the polymeric jacket. The attachment material, upon curing or solidifying, may become an integral part of the catheter shaft 102, seamlessly integrating the structural element into the shaft 102

[0120] In some embodiments, two windows 2200 may be created, positioned on opposite sides of the shaft, 180-degree from the first window. The two windows allow for the attachment material to be introduced through the first window and flow into the circumferential groove. The attachment material fills the groove and continues to flow until the attachment material exits the second window, allowing the user to identify that the process of flowing the attachment material through the window is complete when the attachment material is observed to exit the second window. This ensures the user that the groove is entirely filled and no voids or gaps remain. As the attachment material fills the groove, it creates a direct contact between the structural element and the polymeric jacket 2210. This direct contact allows the attachment material to adhere to both the structural element and the braid 2205, effectively locking the structural element in place and creating a strong bond between the structural element and the polymeric jacket. The attachment material, upon curing or solidifying, may become an integral part of the catheter shaft 102, seamlessly integrating the structural element into the shaft 102.

[0121] The window 2200 of the exposed reinforcing braid 2205 may be created at any desired location along the length of the catheter shaft 102, enabling the positioning of structural elements and mechanically connecting the structural elements at optimal points for force transmission and steering control. Further, by controlling the removal process, the window 2200 can be formed without significantly altering the outer diameter or surface profile of the catheter shaft 102, maintaining a smooth and consistent transition between the shaft and the structural elements.

[0122] In some embodiments, the removal process can be adapted to create the window 2200 of various shapes and sizes, depending on the specific requirements of the catheter design and the structural elements being integrated. For example, elongated openings or slots may be formed to accommodate larger structural elements or to provide multiple points of mechanical connecting along the length of the structural element. Additionally, the number and arrangement of window 2200 of the exposedNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 reinforcing braid 2205 can be varied to optimize the force distribution and steering performance of the catheter 100.

[0123] In some embodiments, the existing polymeric jacket 2210 may be reflowed over the window 2200 to seal and encapsulate the window 2200. The reflowed polymeric material from the existing polymeric jacket 2210 forms a smooth, continuous surface over the exposed reinforcing braid 2204 and the integrated structural elements.

[0124] Referring now to FIG. 12A along with FIGS. 1 and 11 , a reinforcing assembly 2300 is introduced within the medical catheter 100, wherein the selective removal of portions of the polymeric jacket 2210 and mechanical connection 2202 of the reinforcing assembly 2300 is performed at the attachment location corresponding to the window 2200. The reinforcing assembly 2300, is a structural element within the medical catheter that facilitates steering control and maneuverability with the integration of reinforcing sleeves 2302 which may act as a reinforced steering wire guidance system within the catheter shaft, allowing for controlled deflection of the distal portion 106 while providing support and stability to the proximal portion 104. The reinforcing assembly 2300 is positioned within the proximal portion 104 of the medical catheter shaft 102 and extends into the distal portion 106 and comprises reinforcing sleeves 2302 and an anchor ring 2304, wherein the anchor ring 2304 may be composed from a metallic material or of a similar alloy that comprises a circumferential groove 2309 around the anchor ring. The reinforcing sleeves 2302 may comprise a pair of diametrically opposed helical coils that extends longitudinally through the proximal portion 104 of the shaft. Further, the reinforcing sleeves 2302 create dedicated passageways for one or more steering elements (e.g., wires, tendons, ribbons, and the like) 2306, wherein the one or more steering element may comprise a first steering element 2306a and a second steering element 2306b. The one or more steering elements 2306 are located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the shaft 102 as known in the conventional manner. Additionally, the reinforcing sleeves 2302 may provide radial and lateral support and guidance for the one or more steering elements 2306 by encasing them within the helical coils. The protective structure may help minimize the impact of any compressive or any other forces that may occur duringNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 catheter manipulation allowing the steering elements to maintain their integrity and functionally for consistent and precise deflection of the deflection region 108.

[0125] Further, at a distal end of the reinforcing assembly 2308, the reinforcing sleeves 2302 are securely attached to the anchor ring 2304, wherein the anchor ring 2304 includes passageways for the one or more steering elements 2306 extending from the proximal region to the distal region. The anchor ring 2304 features a circumferential groove 2309, wherein the circumferential groove may accommodate an attachment material such as an adhesive, polymeric material, or similar bonding materials. The anchor ring 2304 may be positioned underneath and at center of, or in close proximity to the window 2200 of the exposed reinforcing braid 2205 wherein an attachment material is disposed through the window to fill the space of the circumferential groove 2309 to establish a mechanical connection 2202. The attachment material may flow through the exposed braid 2205 into the groove 2309, filling the voids or gaps and forming a strong bond that prevents slippage and maintains the integrity of the reinforcing assembly 2300. The secure attachment allows for a seamless transfer of steering forces from the proximal portion 104 to the distal portion 106, allowing control and maneuverability of the medical catheter 100.

[0126] In some embodiments, the reinforcing assembly 2300 may be adapted to suit specific catheter designs and applications. Variations in the number, configuration, and / or material composition of the reinforcing sleeves 2302 and anchor ring 2304 may be employed to optimize performance characteristics. For example, the helical coils of the reinforcing sleeves may be designed with different diameters and materials, or the anchor ring may be constructed of various materials to achieve the desired strength, and flexibility.

[0127] Referring now to FIGS. 1 , 11 and FIG. 12B, FIG. 12B introduces the articulation structure 2400 that may be positioned within the distal portion 106 of the medical catheter shaft 102 and facilitates predictable, highly planar deflection of the deflection region 108 by resisting torsional forces on the shaft 102 that would otherwise tend to cause the deflection region 108 to deflect. The articulation structure 2400 may comprise a circumferential groove 2408 formed on its proximal end 2404, wherein the circumferential groove 2408 may accommodate an attachment material such as anNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 adhesive, polymeric material, or similar bonding materials. The circumferential groove 2408 of the articulation structure sits underneath and at center of, or in close proximity to the window 2200 of the exposed groove braid 2205 wherein an attachment material is disposed through the window 2200 to fill the space of the circumferential groove 2408 to establish a mechanical connection 2202. The attachment material may flow through the exposed braid 2205 into the groove 2408, filling the voids or gaps and forming a strong bond that prevents slippage and maintains the integrity of the articulation structure 2400.

[0128] In some embodiments, a separate ring component, similar to the anchor ring 2304 used in the reinforcing assembly 2300, can be attached to the proximal end 2404 of the articulation structure wherein the ring has a circumferential groove that may be positioned underneath and at center, or in close proximity to the window 2200 of the exposed braid 2205. The ring of the articulation structure may securely be attached though the mechanical connection 2202 by flowing an attachment material through the window 2200 into the grooves of the ring in a similar manner as discussed for the anchor ring 2304 in FIG.12A.

[0129] Further, the articulation structure 2400 may comprise series of interconnected plurality of longitudinally-arranged articulation elements that work together to achieve the desired deflection characteristics. These articulation elements may comprise a plurality of longitudinally arranged tubular segments, a plurality of connecting segments, plurality of articulation links, a plurality of joints, a plurality of reinforcing members, or combinations thereof. The articulation structure 2400 may include one or more reinforcing members embedded within the articulation elements and extending through the articulation structure 2400 wherein the reinforcing members may maintain a curved shape of the deflection region 108 during deflection and maintain repeatability of achieving the curved shape of the deflection region 108 during deflection. In an example embodiment the one or more reinforcing members may comprise a helically wound flat ribbon wire or stranded wire cables or of similar elements.

[0130] The articulation structure 2400 may further comprise one or more steering wire lumens, wherein the steering wire lumens may be configured to receive one orNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 more steering elements 2306 that are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner. The one or more steering wire lumens may also be circumferentially offset from the one or more reinforcing members by about 90 degrees. The specific design and arrangement of these elements can vary depending on the desired deflection profile and the intended application of the medical catheter 100.

[0131] FIG. 13 is a top-view illustration of a reinforcing assembly 2300 of the medical catheter 100, according to some embodiments. As shown, the reinforcing assembly 2300 includes the reinforcing sleeves 2302 wherein the reinforcing sleeves 2302 create dedicated passageways for the one or more steering elements 2306. The one or more steering elements 2306 may be located in diametrically opposite positions and are operatively connected to the steering actuator 118 (FIG. 1 ) to facilitate the deflection of at least the deflection region 108 of the tubular shaft 102 as known in the conventional manner.

[0132] FIG. 14 introduces the creation of multiple windows of the exposed reinforcing braid 2200a and 2200b along the catheter shaft 102 to allow for mechanical connection 2202a and 2202b of more than one structural element. This approach allows for the integration of structural elements such as the reinforcing assembly 2300 and the articulation structure 2400 which may contribute to the overall steering performance and stability of the catheter 100. The process may involve selectively removing portions of the polymeric jacket 2210 at specific locations along the catheter shaft 102 creating multiple windows of the exposed reinforcing braid 2200a and 2200b.

[0133] As shown in FIG. 14, the reinforcing assembly 2300 is positioned such that the anchor ring 2304 sits underneath and at center of, or in close proximity to the first window of exposed reinforcing braid 2200a. The anchor ring 2304 features a circumferential groove 2309 that may accommodate an attachment material such as an adhesive, polymeric material, or similar bonding materials, wherein an attachment material is flowed through the window 2200a to fill the space of the circumferential groove 2309 and establish the first mechanical connection 2202a. The attachment material may flow through the exposed braid 2205 into the groove 2309, filling the voidsNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 or gaps and forming a strong bond that prevents slippage and maintains the integrity of the reinforcing assembly 2300.

[0134] Similarly, the articulation structure 2400 may comprise a circumferential groove 2408 formed on its proximal end 2404, wherein the circumferential groove 2408 may accommodate an attachment material such as an adhesive, polymeric material, or similar bonding materials. The circumferential groove 2408 of the articulation structure sits underneath and at center of, or in close proximity to the second window 2200b of the exposed groove braid 2205 wherein an attachment material is flowed through the window 2200b to establish the second mechanical connection 2202b. The attachment material is flowed through the window 2200b to fill the space of the circumferential groove 2408. The attachment material may flow through the exposed braid into the groove 2408, filling the voids or gaps and forming a strong bond that prevents slippage and maintains the integrity of the articulation structure 2400. In some embodiments, a separate ring component, similar to the anchor ring 2304 used in the reinforcing assembly 2300, can be attached to the proximal end 2404 of the articulation structure wherein the ring has a circumferential groove that may be positioned underneath and at center, or in close proximity to the window 2200b of the exposed braid 2205. The ring may be securely attached though the mechanical connection 2202b by flowing an attachment material through the window 2200b into the grooves of the ring.

[0135] The mechanical connections 2202a and 2202b may be done by flowing an attachment material through the windows 2200a and 2200b of the exposed braids 2205 into the circumferential grooves of the reinforcing assembly and articulation structure, wherein the attachment material may be an adhesive, polymeric material, or similar bonding materials that may enhance the connection of the articulation structure and the structural elements to the polymeric jacket. As the attachment material fills the grooves 2309 of the reinforcing assembly and 2408 of the articulation structure, it creates a direct contact of the between these structural elements and to the polymeric jacket 2210. This direct contact allows the attachment material to adhere to both the structural elements (the reinforcing assembly and the articulation structure) and the polymeric jacket 2210, effectively locking them in place and creating a strong bond with the polymeric jacket 2210. The attachment material, upon curing or solidifying, may becomeNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 an integral part of the catheter shaft 102, seamlessly integrating the reinforcing assembly 2300 and the articulation structure 2400 into the shaft 102.

[0136] The positioning of the windows 2200a and 2200b of the exposed reinforcing braid, along with the placement of the reinforcing assembly 2300 and articulation structure 2400 can be tailored based on the specific design requirements of the catheter 100. Factors such as the desired deflection profile, the length of the distal portion 106, and the overall catheter stiffness can influence the optimal placement of these components. In some embodiments, additional windows 2200 of the exposed braid may be created to accommodate mechanical connection to other structural elements or to provide multiple points for mechanical connection to a single structural element. As such, a user may strategically remove the polymeric material by laser ablation or of similar removal process such that length, width, and depth of the window 2200 of the exposed reinforcing braid 2205 may be tailored to a desired size to accommodate the integration of different structural elements to the shaft. Moreover, the pattern and arrangement of the window 2200 of the exposed reinforcing braids 2205 can be modified to achieve specific performance characteristics. For example, helical, staggered or other arrangements of the window 2200 of the exposed reinforcing braids 2205 could be utilized to optimize the flexibility and torsional rigidity of the catheter shaft 102 in specific region to allow for the secure integration of structural elements through the window 2200 of the reinforcing braid 2205 while maintaining a smooth, continuous profile along the catheter shaft 102 contributing to the overall performance, maneuverability, and stability of the steerable medical catheter 100.

[0137] It is well understood that methods that include one or more steps, the order listed is not a limitation of the claim unless there are explicit or implicit statements to the contrary in the specification or claim itself. It is also well settled that the illustrated methods are just some examples of many examples disclosed, and certain steps may be added or omitted without departing from the scope of this disclosure. Such steps may include incorporating devices, systems, or methods or components thereof as well as what is well understood, routine, and conventional in the art.

[0138] The connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and / or physical couplingsNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system. However, the benefits, advantages, solutions to problems, and any elements that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as critical, required, or essential features or elements. The scope is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” Moreover, where a phrase similar to “at least one of A, B, or C” is used in the claims, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B or C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. The terms “couples,” “coupled,” “connected,” “attached,” and the like along with variations thereof are used to include both arrangements wherein two or more components are in direct physical contact and arrangements wherein the two or more components are not in direct contact with each other (e.g., the components are “coupled” via at least a third component), but still cooperate or interact with each other.

[0139] In the detailed description herein, references to “one embodiment,” “an embodiment,” “an example embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art with the benefit of the present disclosure to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.

[0140] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. ForNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims

NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01CLAIMSWe claim:1 . A medical catheter comprising: a handle configured for manipulation by a user; a flexible shaft having a proximal portion, a distal portion, and a transition portion between the proximal and distal portions of the shaft, wherein: the proximal portion of the shaft extends distally from the handle and is formed from a proximal shaft component having a proximal reinforcing braid and a proximal polymeric jacket disposed over the proximal reinforcing braid, wherein a first length of the proximal reinforcing braid extends distally of the proximal polymeric jacket, and the distal portion of the shaft is formed from a distal shaft component having a distal reinforcing braid and a distal polymeric jacket disposed over the distal reinforcing braid, wherein a second length of the distal reinforcing braid extends proximally of the distal polymeric jacket and is mechanically connected to the first length of the proximal reinforcing braid, and wherein the transition portion of the shaft comprises the first length of the proximal braid member, the second length of the distal braid member, and a transition portion jacket disposed over the first length of the proximal braid member and the second length of the distal braid member.

2. The medical catheter of claim 1 , wherein the proximal portion comprises: a reinforcing assembly disposed within the proximal shaft component, the reinforcing assembly comprising:NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 a pair of diametrically opposed helical reinforcing sleeves, wherein the reinforcing sleeves establish reinforced passageways configured to provide lateral support for one or more steering elements extending from the proximal region to the distal region; and an anchor ring attached to a distal end of each of the reinforcing sleeves, the anchor ring comprising a ring structure and including passageways for the one or more steering elements, and wherein the anchor ring is mechanically connected to the proximal shaft component and the distal shaft component in the transition portion.

3. The medical catheter of claim 2, wherein the distal portion comprises a deflectable region defining a longitudinal axis and further comprising an articulation structure disposed within the distal shaft component, the articulation structure comprising: a plurality of longitudinally-arranged tubular segments and a plurality of connecting segments connecting adjacent tubular segments; and one or more steering wire lumens extending through the tubular segments and aligned with the reinforcing sleeves.

4. The medical catheter of claim 3, wherein the deflectable region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft.

5. The medical catheter of claim 3, wherein the one or more steering wire lumens are each circumferentially offset from the connecting segments by about 90 degrees.

6. The medical catheter of claim 2, wherein the first length of the proximal reinforcing braid and the second portion of the distal reinforcing braid overlap one another in the transition portion.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO017. The medical catheter of claim 2, comprising a mechanical connection connecting the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

8. The medical catheter of claim 7, wherein the mechanical connection further connects the anchor ring to the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

9. The medical catheter of claim 7, wherein the transition portion jacket is formed from polymeric material reflowed over and around the mechanical connection connecting the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid.

10. The medical catheter of claim 9, wherein the mechanical connection is formed by at least one joining method including welding process, soldering process, adhesive process, polymer reflow process, or combination thereof.11 . The medical catheter of claim 8, wherein the anchor ring includes a groove defined in its outer circumference, and wherein the mechanical connection is formed by disposing an adhesive material over the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid and into the groove.

12. The medical catheter of claim 8, wherein the mechanical connection comprises a weld joint connecting the first length of the proximal reinforcing braid, the second length of the distal reinforcing braid, and the anchor ring.

13. The medical catheter of any of claims 1 -12, wherein the proximal polymeric jacket and the distal polymeric jacket are made from different polymeric materials.

14. The medical catheter of any of claims 1 -13, wherein the first length of the proximal reinforcing braid and the second length of the distal reinforcing braid are dimensioned to define, in the absence of the transition portion jacket, a gapNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 between the proximal polymeric jacket and the distal polymeric jacket having a length of about 0.030 inches to about 0.300 inches.

15. The medical catheter of claim 14, wherein the transition portion jacket fills and seals the gap.

16. A medical catheter comprising: a handle configured for manipulation by a user; a flexible shaft comprising a reinforcing braid and a polymeric jacket disposed over the reinforcing braid, the flexible shaft having a proximal portion, and a distal portion, the shaft further comprising a structural element is positioned within the shaft, wherein the structural element is mechanically connected to the reinforcing braid at an attachment location via a mechanical connection establishing a secure bond between the reinforcing braid and the structural element, and wherein the mechanical connection is formed by exposing the reinforcing braid by selective removal of the polymeric jacket material, and mechanically connecting the braid to the structural element.

17. The medical catheter of claim 16, wherein the structural element is configured to provide reinforcement to the flexible shaft or transmit forces along the flexible shaft.

18. The medical catheter of claim 16, wherein the mechanical connection comprises a welded connection between the reinforcing braid and the structural element.

19. The medical catheter of claim 16, wherein the selective removal of the polymeric jacket is performed at any location along the length of the flexible shaft.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO0120. The medical catheter of claim 16, wherein the polymer jacket is removed to expose the reinforcing braid at one or more locations along the flexible shaft, allowing for the mechanical connection of the structural element at each of the one or more locations.21 . The medical catheter of claim 16, wherein the selective removal of the polymeric jacket is controlled to create a desired size and shape of exposure of the reinforcing braid.

22. The medical catheter of claim 16, wherein the structural element is a reinforcing assembly, wherein the reinforcing assembly is positioned within the proximal portion of the shaft, wherein the reinforcing assembly comprises: a pair of diametrically opposed helical reinforcing sleeves extending through the proximal portion of the shaft; and an anchor ring attached to a distal end of the reinforcing sleeves, the anchor ring comprising a ring structure.

23. The medical catheter of claim 22, wherein the reinforcing sleeves establish reinforced passageways configured to provide radial and lateral support for one or more steering elements extending from the proximal region to the distal region.

24. The medical catheter of claim 22, wherein the anchor ring includes passageways for the one or more steering elements extending from the proximal region to the distal region.

25. The medical catheter of claim 24, wherein the anchor ring of the reinforcing assembly is positioned in close proximity to the attachment location.

26. The medical catheter of claim 25, wherein the anchor ring is connected through the mechanical connection to the reinforcing braid at the attachment location.NM Ref.: 051666 / 13741BSC Ref.: 23-1147WO0127. The medical catheter of claim 16, wherein the structural element is an articulation structure positioned within the distal portion of the shaft, the articulation structure having a proximal end, wherein the articulation structure comprises: a plurality of longitudinally-arranged articulation elements, one or more steering wire lumens, wherein the steering wire lumens extend through the articulation structure, and one or more reinforcing members extending through the articulation elements.

28. The medical catheter of claim 16, wherein the structural element is a single helical cable that comprises a proximal end and distal end, wherein the single helical cable extends longitudinally through the proximal shaft, and wherein the single helical cable provides structural support to the proximal shaft.

29. The medical catheter of claim 28, wherein the distal end of the single helical cable is positioned in close proximity to the attachment location.

30. The medical catheter of claim 29, wherein the distal end of the single helical cable is connected through the mechanical connection to the reinforcing braid at the attachment location.31 . A medical catheter comprising: a handle configured for manipulation by a user; and a flexible shaft comprising a reinforcing braid and a polymeric jacket disposed over the reinforcing braid, the flexible shaft having a proximal portion, and a distal portion, wherein a structural element is positioned within the shaft, wherein the structural element is mechanically connected to the polymeric jacket via a mechanical connection establishing a secure bond between the polymeric jacket and the structural element, andNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 wherein the mechanical connection is formed by selectively removing a portion of the polymeric jacket to create a window exposing a portion of the reinforcing braid and disposing an attachment material through the window and the exposed portion of the reinforcing.

32. The medical catheter of claim 31 , wherein the structural element comprises a circumferential groove configured to receive the attachment material.

33. The medical catheter of claim 32, wherein the circumferential groove is formed on an outer surface of the structural element.

34. The medical catheter of claim 32, wherein the circumferential groove is positioned in close proximity to the window of the exposed reinforcing braid.

35. The medical catheter of claim 34, wherein the attachment material is disposed through the window of the exposed portion of the reinforcing braid into the groove of the structural element to establish the mechanical connection.

36. The medical catheter of claim 35, wherein the attachment material is an adhesive, a polymeric material, or other similar bonding materials.

37. The medical catheter of claim 31 , wherein the selective removal of the polymeric jacket is controlled to create a desired size and shape of the window of the exposed reinforcing braid.

38. The medical catheter of claim 31 , wherein the structural element is a reinforcing assembly, wherein the reinforcing assembly is positioned within the proximal portion of the shaft, wherein the reinforcing assembly comprises: a pair of diametrically opposed reinforcing sleeves extending through the proximal portion of the shaft, wherein the reinforcing sleeves establish passageways configured for one or more steering elements extending from the proximal region to the distal region of the shaft; andNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 an anchor ring attached to a distal end of each of the reinforcing sleeves, the anchor ring comprising a ring having a groove defined around its circumference.

39. The medical catheter of claim 38, further comprising a pair of diametrically opposed steering elements each extending through a respective one of the reinforcing sleeves, wherein the reinforcing sleeves each provide radial and lateral support for the steering elements extending therethrough.

40. The medical catheter of claim 38, wherein the anchor ring includes a pair of diametrically opposed passageways aligned with the passageways of the reinforcing sleeves, and when each of the steering elements extends through a respective one of the passageways in the anchor ring.41 . The medical catheter of claim 40, wherein the anchor ring of the reinforcing assembly is positioned in close proximity to the window of the exposed reinforcing braid.

42. The medical catheter of claim 41 , wherein the attachment material is disposed through the window of the exposed reinforcing braid into the groove of the anchor ring to establish the mechanical connection.

43. The medical catheter of claim 31 , wherein the structural element is an articulation structure positioned within the distal portion of the shaft, the articulation structure having a proximal end, wherein the articulation structure comprises: a plurality of longitudinally-arranged articulation elements, one or more steering wire lumens, wherein the steering wire lumens extend through the articulation structure, one or more reinforcing members extending through the articulation elements, andNM Ref.: 051666 / 13741BSC Ref.: 23-1147WO01 a circumferential groove formed on the proximal end of the articulation structure.

44. The medical catheter of claim 43, wherein the articulation elements comprise a plurality of tubular segments, a plurality of connecting segments, a plurality of articulation links, a plurality of joints, a plurality of reinforcing members, or combinations thereof.

45. The medical catheter of claim 44, wherein the attachment material is disposed through the window of the exposed reinforcing braid into the groove of the articulation structure to establish the mechanical connection.

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