Device for catheter joint exercise system

A mechanical barrier in catheter systems prevents damage to the flexible tube by distributing force, improving the catheter's deflection and navigation capabilities.

JP2025104327APending Publication Date: 2025-07-09BIOSENSE WEBSTER (ISRAEL) LTD
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Patent Information

Application Number
JP2024230055
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-02-06
Filing Date
2024-12-26
Publication Date
2025-07-09

AI Technical Summary

Technical Problem

Existing catheter articulation systems risk damaging the flexible tube due to excessive tension or pressure applied to the pull wire or push rod, rendering the anchor member ineffective.

Method used

Incorporating a mechanical barrier between the anchor member and the elongate tube, which includes a lumen to receive the anchor member, preventing damage and distributing force effectively.

Benefits of technology

The mechanical barrier prevents damage to the flexible tube while enhancing the deflection capability of the catheter tip, ensuring reliable navigation and operation.

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Abstract

To provide a medical probe.SOLUTION: The disclosed technology includes a medical probe that includes: an elongated tube extending along a longitudinal axis from a proximal end to a distal end; an actuator member extending along the elongated tube from approximately the proximal end to approximately the distal end; an anchor member attached to the actuator member near the distal end of the elongated tube; and a mechanical barrier disposed between the anchor member and the elongated tube. The mechanical barrier can include a lumen extending through the mechanical barrier along a lumen axis. The lumen can be configured to at least partially receive the anchor member.SELECTED DRAWING: Figure 1
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Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is a partial continuation application of U.S. Patent Application No. 18 / 397,675, filed on December 27, 2023 (Attorney Docket No.: 253757.000415 - BIO6878USNP1), the entire contents of each of which are hereby incorporated by reference in their entirety as if fully set forth herein.

[0002] (Field of the Invention) The present invention generally relates to medical devices, and more particularly to a device for a catheter that can deflect the distal end of the catheter away from the longitudinal axis.

Background Art

[0003] Catheter devices are commonly used in medical procedures when a medical device needs to reach an organ, tissue, or other difficult - to - reach part of a patient's body. Typically, a catheter includes a flexible tube or shaft that is inserted through a patient's vasculature or other area and navigated to a target location. To assist in guiding the catheter to the target location, the catheter often includes a flexible distal tip that can be articulated to help navigate the catheter through the patient's vasculature. In many cases, the articulation system includes a pull - wire or push - rod that is fixed near the distal end of the flexible tube or shaft and connected to an actuator on a handle that is operated by a medical professional. When the medical professional actuates the actuator to pull the pull - wire in the proximal direction or push the push - rod in the distal direction, the flexible distal tip articulates in a predetermined direction (i.e., bends away from the longitudinal axis of the flexible tube).

[0004] Some existing catheter articulation systems include an anchor member configured to connect the distal end of a flexible tube to either a pull wire or a push rod. However, some existing anchor members may bite into or otherwise damage the flexible tube if excessive tension or pressure is applied to the pull wire or push rod. When this occurs, the pull wire or push rod may become ineffective at articulating the flexible distal tip.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0005] Accordingly, there is a need in the art for an articulation system configured to help prevent an anchor member from damaging a flexible tube. These and other problems can be addressed by the techniques disclosed herein.

MEANS FOR SOLVING THE PROBLEMS

[0006] The disclosed technique includes a medical probe that includes an elongate tube extending along a longitudinal axis from a proximal end to a distal end, an actuator member extending along the elongate tube from approximately the proximal end to approximately the distal end, an anchor member attached to the actuator member near the distal end of the elongate tube, and a mechanical barrier disposed between the anchor member and the elongate tube. The mechanical barrier can include a lumen extending through the mechanical barrier along a lumen axis. The lumen can be configured to at least partially receive the anchor member.

[0007] The disclosed technology can further include a medical device including an elongated tube extending along a longitudinal axis from a proximal end to a distal end, an actuator member extending along the elongated tube, and an anchor member attached to the actuator member near the distal end of the elongated tube. The actuator member and the anchor member can be configured to deflect a deflectable tip of the elongated tube radially outward from the longitudinal axis during actuation. The medical device can further include a mechanical barrier disposed between the anchor member and the elongated tube. The mechanical barrier can be configured to prevent the anchor member from damaging the elongated tube.

Brief Description of the Drawings

[0008] The above and further aspects of the present invention will be further considered with reference to the following description in conjunction with the accompanying drawings, in which like numerals in the various figures indicate like structural elements and features. The drawings are not necessarily to scale and instead are primarily focused on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention by way of example and not limitation.

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DETAILED DESCRIPTION OF THE INVENTION

[0009] The disclosed technology includes a device for a catheter articulation system that can help prevent an anchor member from damaging a flexible tube. Further, the devices described herein can help better secure an anchor to the distal end of a flexible tube and provide a levering action to the distal end of the flexible tube to help deflect the distal end of the flexible tube away from the longitudinal axis when a pull wire or push rod is actuated. The disclosed technology includes various designs for mechanical barriers that can be disposed between an anchor and a flexible tube to help protect the flexible tube. In this way, the disclosed technology can be configured for use with existing catheter systems and serves as a simple and cost-effective way to prevent an anchor from damaging a flexible tube.

[0010] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is by way of example, and illustrates the principles of the invention. This description enables one skilled in the art to make and use the invention and describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered to be the best mode of carrying out the invention.

[0011] As used herein, the term "about" or "substantially" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a part or collection of components to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%.

[0012] As used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the use of the system or method to human use, although the use of the present invention in human patients represents a preferred embodiment. Additionally, the vasculature of a "patient," "host," "user," and "subject" can be any human or animal vasculature. It should be understood that the animal can be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal can be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient. Similarly, the term "proximal" indicates the position closer to the operator or physician, while "distal" indicates the position farther from the operator or physician.

[0013] As contemplated herein, "physician," "operator," or "medical professional" can include an internist, surgeon, technician, scientist, or any other individual or delivery instrument related to the delivery of a multi-electrode catheter to a subject for the treatment of drug-resistant atrial fibrillation.

[0014] As contemplated herein, the term "ablating" or "ablation" relates to the devices and corresponding systems of the present disclosure and refers to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing energy delivered to tissue. These techniques can include ablation techniques such as irreversible electroporation (IRE), radio frequency (RF) ablation, and cryoablation.

[0015] Refer to FIG. 1 showing an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes one or more catheters that are percutaneously inserted by a physician 24 through the vasculature of a patient 23 into a cardiac chamber or vascular structure of the heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location of the heart 12. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The one or more catheters can include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. For ablation, the physician 24 similarly delivers an end effector 28 including an ablation electrode to a target site for ablation. If the end effector 28 is alternatively or additionally configured for mapping electrophysiology signals (e.g., IEGM signals), the physician 24 similarly contacts the end effector 28 with a target site (e.g., the heart wall) to sense IEGM signals at the target site within the heart 12.

[0016] Catheter 14 is an exemplary catheter including an end effector 28, the end effector 28 having an expandable assembly and one and preferably a plurality of electrodes 26 optionally distributed over a distal tip of the end effector 28 and configured to detect electrophysiology signals and / or deliver ablation energy to tissue. Although catheter 14 is shown as a lasso catheter in FIG. 1, it will be understood that the disclosed techniques can be used with other types of catheters including, but not limited to, basket catheters, balloon catheters, planar catheters, focus catheters, and delivery sheaths.

[0017] The catheter 14 may additionally include a magnetic-based position sensor embedded within or near the end effector 28 to track the position and orientation of the end effector 28. The end effector 28 may further include one or more impedance-based electrodes disposed within or near the end effector 28 to track the position and orientation of the end effector 28.

[0018] The magnetic-based position sensor may operate with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 28 of the catheter 14 may be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor may be a uniaxial sensor, a biaxial sensor, or a triaxial sensor, depending on the particular configuration. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0019] The system 10 includes one or more electrode patches 38 disposed for skin contact on the patient 23 to establish a position reference for the position pad 25 and to track the impedance-based electrodes. For impedance-based tracking, a current is directed to the impedance-based electrodes and sensed at the electrode-skin patch 38, whereby the position of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference as if fully set forth herein.

[0020] Recorder 11 displays the electrocardiogram 21 captured by the body surface ECG electrode 18 and the intracardiac electrogram (IEGM) captured by the electrodes of the catheter 14. The recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacemaker.

[0021] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes disposed on an end effector and configured to deliver ablation energy to tissue. The energy generated by ablation energy generator 50 may include radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, such as monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE), or combinations thereof, but is not limited thereto.

[0022] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, electrophysiological equipment, a power source, and a workstation 55 that controls the operation of system 10. The electrophysiological equipment of system 10 may include, for example, a plurality of catheters, position pads 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities for implementing real-time calculation of the position of the catheter and performing ECG calculations.

[0023] The workstation 55 includes a memory, a processor unit having a memory or a storage device loaded with appropriate operating software, and a user interface function. The workstation 55 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 20 on a display device 27; (2) displaying on the display device 27 a representative visual representation or image of an activation sequence (or other data) compiled from the recorded electrogram 21 superimposed on the rendered anatomical map 20; (3) displaying the real-time positions and orientations of a plurality of catheters within the heart chamber; and (4) displaying on the display device 27 regions of interest such as locations where ablation energy is being applied. One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0024] FIG. 2 is a schematic drawing of a mechanical barrier 100 for a medical probe (e.g., catheter 14) according to the techniques of the present disclosure. As previously explained, existing catheters often include a pull wire or push rod attached to an anchor at the distal end of the catheter. If a medical professional pulls or pushes on the pull wire or push rod too strongly, respectively, the anchor can apply excessive force to the elongate tube and damage the elongate tube. Thus, as will become apparent through the present disclosure, the mechanical barrier 100 can be assembled with an anchor (see 130 in FIG. 3A) at the distal end (deflectable tip 140) of the elongate tube (see 131 in FIG. 3A) of the catheter 14 to help prevent the anchor from damaging the elongate tube.

[0025] The mechanical barrier 100 can include a body 110 that extends from a first end 112 to a second end 114. The body 110 can be made of a suitable biocompatible material having a hardness greater than that of the elongate tube 131. The body 110 can define a lumen 120 that extends through the body 110 near the first end 112 and an arm 116 that extends outwardly toward the second end 114. The lumen 120 can have an inner diameter 122, and the body 110 forms a circular end near the first end 112 that defines an outer diameter 124. The outer diameter 124 can be larger than the inner diameter 122. The body 110 can further include a rounded edge 111 to reduce the likelihood that the mechanical barrier 100 will damage the elongate tube 131. The body 110 can be sized as shown in FIG. 2, or the body 110 can be enlarged on one side, tapered from one side to the other side, thicker on one side, and / or any other shape suitable for a particular application.

[0026] FIG. 3A is a front perspective view of a medical probe (e.g., catheter 14) comprising an elongate tube 131, an anchor member 130, and a mechanical barrier 100 in a first position, according to the disclosed technique. The portion of the medical probe shown in FIG. 3A comprises an elongate tube 131 that extends along a longitudinal axis LA and has a deflectable tip 140. For example, the portion of the medical probe shown in FIG. 3A can be the deflectable tip 140 near the distal end of the elongate tube 131 configured to articulate for navigation of the catheter 14 to a target region within a patient's body. The deflectable tip 140 can further include a recess 141 formed in an edge of the deflectable tip 140 configured to receive the anchor member 130 such that the anchor member 130 can fit better within the catheter 14.

[0027] The anchor member 130 can be configured to be attached to a pull wire or a push rod (not shown). For example, the anchor member 130 can include a ferrule 132 that can be attached to the pull wire or the push rod by crimping, soldering, adhesively bonding, or other means. When a medical professional actuates the pull wire or the push rod, the force applied to the pull wire or the push rod is distributed to the anchor member 130, and as a result, is distributed to the deflectable tip 140. The anchor member 130 can further include one or more extensions 134 that extend outwardly from the ferrule 132 to prevent the anchor member 130 from being pulled back through the lumen of the elongate tube 131. The anchor member 130 can further include one or more pads 135 attached to the extensions 134 to help prevent further damage to the anchor member 130 when the anchor member 130 is pulled in the proximal direction or pushed in the distal direction.

[0028] As shown in FIG. 3A, the mechanical barrier 100 can be disposed proximal to the anchor member 130 such that when a medical professional pulls on the pull wire, the anchor member 130 contacts the mechanical barrier 100 and the mechanical barrier 100 can help prevent the anchor member 130 from damaging the elongate tube 131. The anchor member 130 can be configured to at least partially extend within the lumen 120 of the mechanical barrier 100. In some examples, the ferrule 132 can extend through the lumen 120 to prevent the mechanical barrier 100 from being removed from the anchor member 130 and the elongate tube 131. However, the anchor member 130 can rotate freely within the lumen 120.

[0029] Figure 3B is a front perspective view of a medical probe comprising an elongate tube 131, an anchor member 130, and a mechanical barrier 100 in a second position, according to the disclosed technique. In this example, the mechanical barrier 100 can be disposed at the distal end of the anchor member 130 such that when a medical professional presses on a push rod (not shown) attached to the anchor, the mechanical barrier 100 can help prevent the anchor member 130 from damaging the elongate tube 131 at the distal end of the elongate tube 131. All other features shown in Figure 3B can be the same as the features shown and described in connection with Figure 3A.

[0030] The elongate tube 131 is shown as translucent in the example shown in Figure 3B to show an arm 116 of the mechanical barrier 100 that extends at least partially within a central lumen 142 of the elongate tube 131. For example, the arm 116 can extend through a slot formed in the elongate tube 131 that extends from an outer portion of the elongate tube 131 to an inner portion of the elongate tube 131 (e.g., the central lumen 142). The arm 116 can help distribute the force applied to the anchor member 130 by providing a moment arm towards the center of the elongate tube 131, thereby enabling better deflection of the deflectable tip 140 compared to existing systems.

[0031] Figure 4 is a top view of a medical probe comprising an elongate tube 131, an anchor member 130, and a mechanical barrier 100 in a first position, according to the disclosed technique. As shown, the arm 116 can extend substantially throughout the central lumen 142 towards the center of the deflectable tip 140. The elongate tube 131 can include additional lumens configured for electrical wiring, irrigation fluid, or other components. In some examples, the arm 115 can extend within one or more lumens in addition to, or instead of, the central lumen 142. Figure 4 also shows an alternative view of the recess 141 formed within the deflectable tip 140. As shown, the recess 141 can be sized to receive the anchor member 130 such that the anchor member 130 can fit within the outer edge of the deflectable tip 140 such that an end effector can be attached to the deflectable tip. The end effector can be, for example, an end effector configured for ablation and / or mapping of tissue attached to the deflectable tip 140. In some embodiments, the mechanical barrier 100 is attached to components that extend through the central lumen 142 (or other lumens formed within the elongate tube 131), such as components of the end effector, electrical components, or irrigation components, and can assist in providing additional support for such components.

[0032] FIG. 5 is a front perspective view of a medical probe comprising an elongate tube 131, an anchor member 130, and an alternative mechanical barrier 500 according to the disclosed technique. As shown, the mechanical barrier 500 can be substantially similar to the mechanical barrier 100, except that the mechanical barrier 500 can further include a first wing 162 and a second wing 164 that extend outwardly from the body 110 near the first end 112 on either side of the lumen 120. The first wing 162 and the second wing 164 can be configured to fit within the recess 141 and contact the elongate tube 131. The first wing 162 and the second wing 164 can each extend outwardly from the body 110 in a semi-circular shape. As will be appreciated, the first wing 162 and the second wing 164 can be configured to help distribute the force applied to the elongate tube 131 by the anchor member 130 via the mechanical barrier 500 by increasing the area over which the force from the anchor member 130 is distributed. The first wing 162 and the second wing 164 can have different shapes and sizes and can be configured as a single enlarged component extending from the body 110. It will be understood that the first wing 162 and the second wing 164 may be substantially symmetric with respect to each other, or the first wing 162 and the second wing 164 may be arranged in different shapes, sizes, or otherwise depending on a particular configuration.

[0033] FIG. 6 is a perspective view of another example of a mechanical barrier 600 according to the techniques of the present disclosure. As shown, the mechanical barrier 600 can include a first wing 162 and a second wing 164 similar to the mechanical barrier 500. However, the mechanical barrier 600 can further include one or more ledges 180 that can extend upwardly from the first wing 162 and the second wing 164. The one or more ledges 180 can be aligned with and configured to be stationary relative to the anchor member 130. The one or more ledges 180 can extend in a semi-circular circumferential direction around the axis of the lumen 120. When assembled together, the one or more ledges 180 can help hold the anchor member 130 within the recess 141 and prevent the anchor member 130 from rotating about the axis defined by the lumen 120.

[0034] FIG. 7 is a perspective view of yet another exemplary mechanical barrier 700 and fastener 190 according to the disclosed techniques. The mechanical barrier 700 can include some or all of the same features described in connection with the mechanical barriers 100, 500, and 600 described hereinabove, but the mechanical barrier 700 can further include a second lumen 720 that extends through the arm 116 near the second end 114. The second lumen 720 can have a second lumen diameter 722 that is sized to at least partially receive the fastener 190. The fastener 190 can be configured to extend at least partially within the second lumen 720 to help secure the mechanical barrier 700 to the deflectable tip 140. The fastener 190 can include a circular base 192 and a cylindrical member 196 that extends outwardly from the circular base 192. For example, the circular base 192 can be the head of the fastener and the circular member 196 can be the elongated portion of the fastener.

[0035] FIG. 8A is a side perspective view of a medical probe comprising an elongate tube 131, an anchor member 130, a mechanical barrier 700, and a fastener 190 according to the disclosed technique. As shown, the mechanical barrier 700 can be assembled with the anchor member 130 and the deflectable tip 140 as described above with the arm 116 extending into the central lumen 142. Next, the fastener 190 can be inserted into the central lumen 142 and aligned with the second lumen 720. As further shown in FIG. 8B (a different side view) and FIG. 8C (a top view), the fastener 190 can then be inserted into the second lumen 720. The diameter of the second lumen 720 can be made smaller than the diameter of the first lumen 120. Alternatively, the diameter of the second lumen 720 can be the same as or larger than the first lumen 120. As will be appreciated, the fastener 190 can be configured to further assist in fixing the mechanical barrier 700 in place and dispersing the force applied to the anchor member 130 towards the center of the deflectable tip 140. The fastener 190 can be secured to the mechanical barrier 700 by press fitting, complementary threaded features, soldering, welding, adhesives, or any other suitable method known in the art.

[0036] FIG. 9A is a flowchart of a method 900 for manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 900 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 900 can include step 902 of inserting an actuator (e.g., a pull wire or push rod) through a lumen extending through an insertion tube (e.g., elongate tube 131). Method 900 can further include step 904 of inserting the actuator through a lumen of a mechanical barrier (e.g., mechanical barriers 100, 500, 600, or 700) (e.g., lumen 120), and step 906 of attaching an anchor (e.g., anchor member 130) to the distal end of the actuator. Method 900 can further include step 908 of aligning the anchor and the mechanical barrier within a recess of the insertion tube.

[0037] Figure 9B is a flowchart showing another method 910 of manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 910 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 910 can include step 912 of inserting an actuator (e.g., a pull wire or push rod) through a lumen (e.g., lumen 120) of a mechanical barrier (e.g., mechanical barriers 100, 500, 600, or 700), and step 914 of attaching an anchor (e.g., anchor member 130) to the distal end of the actuator. Method 910 can include step 916 of inserting the actuator through a lumen extending through an insertion tube (e.g., elongate tube 131). Method 910 can further include step 918 of aligning the anchor and the mechanical barrier within a recess of the insertion tube.

[0038] Figure 10A is a flowchart showing another method 1000 of manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 1000 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 1000 can include step 1002 of inserting an actuator (e.g., a pull wire or push rod) through a lumen extending through an insertion tube (e.g., elongate tube 131). Method 1000 can include step 1004 of inserting the actuator through a lumen of an anchor (e.g., anchor member 130), and step 1006 of attaching a mechanical barrier (e.g., mechanical barriers 100, 500, 600, or 700) to the distal end of the actuator. Method 1000 can further include step 1008 of aligning the anchor and the mechanical barrier within a recess of the insertion tube.

[0039] Figure 10B is a flowchart showing another method 1010 of manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 1010 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 1010 can include step 1012 of inserting an actuator (e.g., a pull wire or a push rod) through a lumen extending through an insertion tube (e.g., elongate tube 131), and step 1014 of inserting the actuator through a lumen of a mechanical barrier (e.g., mechanical barrier 100, 500, 600, or 700). Method 1010 can further include step 1016 of attaching an anchor to the actuator, and step 1018 of aligning the anchor and the mechanical barrier within a recess of the insertion tube.

[0040] Figure 11A is a flowchart showing yet another method 1100 of manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 1000 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 1200 can include step 1102 of inserting an actuator (e.g., a pull wire or a push rod) through a lumen extending through an insertion tube (e.g., elongate tube 131). Method 1100 can include step 1104 of inserting the actuator through a first lumen (e.g., lumen 120) of a mechanical barrier (e.g., mechanical barrier 100, 500, 600, or 700), and step 1106 of attaching an anchor (e.g., anchor member 130) to an end of the actuator. Method 1000 can further include step 1108 of aligning the anchor and the mechanical barrier within a recess of the insertion tube, and step 1110 of inserting a fastener (e.g., fastener 190) into a second lumen (e.g., second lumen 720) of the mechanical barrier, thereby further attaching the fastener to the mechanical barrier within the distal tip.

[0041] Figure 11B is a flowchart showing yet another method 1120 of manufacturing a medical probe according to the techniques of the present disclosure. In some examples, the medical probe disclosed in method 1120 is substantially similar to any of the medical probes illustrated and described in connection with FIGS. 2-8C. Method 1120 can include step 1122 of inserting an actuator (e.g., a pull wire or push rod) through a lumen (e.g., lumen 120) of a mechanical barrier (e.g., mechanical barriers 100, 500, 600, or 700), and step 1124 of attaching an anchor (e.g., anchor member 130) to the distal end of the actuator. Method 1120 can include step 1126 of inserting the actuator through a lumen extending through an insertion tube (e.g., elongate tube 131). Method 1120 can further include step 1128 of aligning the anchor and the mechanical barrier within a recess of the insertion tube, and step 1130 of inserting a fastener (e.g., fastener 190) within a second lumen (e.g., second lumen 720) of the mechanical barrier, thereby further attaching the fastener to the mechanical barrier within the distal tip.

[0042] The methods described herein can be used with the devices and features described herein. These methods are provided for illustrative purposes and should not be construed as limited to including only the elements described herein, and can include steps and / or alternative orders of intervening steps not described herein.

[0043] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0044] Clause 1: A medical probe, comprising: an elongate tube extending along a longitudinal axis from a proximal end to a distal end; an actuator member extending along the elongate tube from substantially the proximal end to substantially the distal end; and an anchor member attached to the actuator member near the distal end of the elongate tube. A mechanical barrier disposed between an anchor member and an elongate tube, the mechanical barrier comprising a lumen extending through the mechanical barrier along a lumen axis, A medical probe comprising a lumen configured to at least partially receive the anchor member.

[0045] Item 2: The medical probe according to Item 1, wherein the mechanical barrier is disposed adjacent to the anchor member.

[0046] Item 3: The medical probe according to Item 1, wherein the mechanical barrier is disposed distal to the anchor member.

[0047] Item 4: The medical probe according to Item 1, wherein the anchor member comprises a ferrule extending along a ferrule axis and one or more extensions extending outwardly from the ferrule perpendicular to the ferrule axis.

[0048] Item 5: The medical probe according to Item 1, wherein the actuator member comprises at least one of a pull wire or a rod.

[0049] Item 6: The medical probe according to Item 1, wherein the mechanical barrier is configured to prevent the anchor member from damaging the elongate tube.

[0050] Item 7: The medical probe according to Item 1, wherein the mechanical barrier further comprises one or more ledges extending outwardly from the mechanical barrier in a direction along the lumen axis, the one or more ledges being configured to assist in aligning the anchor member along the elongate tube when assembled with the mechanical barrier.

[0051] Item 8: The medical probe according to Item 7, wherein the one or more ledges extend in a semi-circular circumferential direction around the lumen axis.

[0052] Item 9: The medical probe further comprises one or more wings extending outwardly from the mechanical barrier near the first end, and the one or more wings are configured to fit within a recess defined by the elongate tube, the medical probe according to claim 1.

[0053] Item 10: The one or more wings are in a semi-circular shape and extend outwardly from the mechanical barrier, the medical probe according to item 9.

[0054] Item 11: The one or more wings comprise a first wing and a second wing, and the first wing is disposed on the opposite side of the second wing with respect to the lumen axis, the medical probe according to item 10.

[0055] Item 12: The mechanical barrier further comprises an arm extending outwardly from the mechanical barrier perpendicular to the lumen axis, and the arm is configured to extend into a lumen defined by the elongate tube, the medical probe according to claim 1.

[0056] Item 13: The lumen is a first lumen disposed near the first end of the mechanical barrier, and the mechanical barrier further defines a second lumen extending through the arm near the second end of the mechanical barrier opposite the first end, and the medical probe further comprises a fastener configured to extend at least partially into the second lumen to fix the mechanical barrier to the elongate tube when assembled with the elongate tube, the medical probe according to item 12.

[0057] Item 14: The fastener comprises a substantially circular base having a first diameter and a substantially cylindrical member having a second diameter, the first diameter being larger than the second diameter, and the substantially cylindrical member extending outwardly from the substantially circular base, the medical probe according to item 13.

[0058] Item 15: The substantially cylindrical member is configured to be at least partially disposed within the second lumen, the medical probe according to item 14.

[0059] Item 16: The medical probe according to item 14, wherein the generally cylindrical member is further configured to be at least partially fixed within the second lumen via at least one of press-fitting, complementary threading features, soldering, welding, and adhesives.

[0060] Item 17: The medical probe according to item 14, wherein the second lumen has a second lumen inner diameter, and the second lumen inner diameter is smaller than the inner diameter of the first lumen.

[0061] Item 18: A medical device, comprising: an elongate tube extending along a longitudinal axis from a proximal end to a distal end; an actuator member extending along the elongate tube; an anchor member attached to the actuator member near the distal end of the elongate tube, wherein the actuator member and the anchor member are configured to deflect a deflectable tip of the elongate tube radially outward from the longitudinal axis during operation; and a mechanical barrier disposed between the anchor member and the elongate tube, the mechanical barrier being configured to prevent the anchor member from damaging the elongate tube.

[0062] Item 19: The medical device according to item 18, wherein the mechanical barrier defines a lumen extending through the mechanical barrier along a lumen axis and configured to receive at least a portion of the anchor member, and an arm extending outward from the mechanical barrier perpendicular to the lumen axis and configured to extend into a lumen defined by the deflectable tip.

[0063] Item 20: The medical device according to item 19, wherein the lumen is the first lumen, the lumen axis is the first lumen axis, the mechanical barrier further defines a second lumen extending through the arm along a second lumen axis, and the mechanical barrier further comprises a fastener configured to extend at least partially into the second lumen to fix the mechanical barrier to the deflectable tip when assembled with the deflectable tip.

[0064] The above-described embodiments are cited as examples, and the present invention is not limited to what has been specifically illustrated and described in this specification above. Rather, the scope of the present invention includes both the combinations and sub-combinations of the various features described and illustrated above, as well as those variations and modifications thereof that are not disclosed in the prior art and that would be recalled by those skilled in the art upon reading the foregoing description.

[0065] 〔Embodiment〕 (1) A medical probe, comprising: an elongated tube extending along a longitudinal axis from a proximal end to a distal end; an actuator member extending along the elongated tube from substantially the proximal end to substantially the distal end; an anchor member attached to the actuator member near the distal end of the elongated tube; a mechanical barrier disposed between the anchor member and the elongated tube, the mechanical barrier comprising a lumen extending through the mechanical barrier along a lumen axis; and wherein the lumen is configured to at least partially receive the anchor member. (2) The medical probe according to embodiment 1, wherein the mechanical barrier is disposed in proximity to the anchor member. (3) The medical probe according to embodiment 1, wherein the mechanical barrier is disposed distally of the anchor member. (4) The medical probe according to embodiment 1, wherein the anchor member comprises a ferrule extending along a ferrule axis and one or more extensions extending outwardly from the ferrule perpendicular to the ferrule axis. (5) The medical probe according to embodiment 1, wherein the actuator member comprises at least one of a pull wire or a rod.

[0066] (6) The medical probe according to embodiment 1, wherein the mechanical barrier is configured to prevent the anchor member from damaging the elongated tube. (7) The mechanical barrier further comprises one or more ledges extending outwardly from the mechanical barrier in a direction along the lumen axis, and the one or more ledges are configured to assist in aligning the anchor member along the elongated tube when assembled with the mechanical barrier. The medical probe according to Embodiment 1. (8) The one or more ledges extend in a semi-circular direction around the lumen axis. The medical probe according to Embodiment 7. (9) The medical probe further comprises one or more wings extending outwardly from the mechanical barrier near the first end, and the one or more wings are configured to fit into a recess defined by the elongated tube. The medical probe according to Embodiment 1. (10) The one or more wings extend outwardly from the mechanical barrier in a semi-circular shape. The medical probe according to Embodiment 9.

[0067] (11) The one or more wings comprise a first wing and a second wing, and the first wing is disposed on the opposite side of the second wing with respect to the lumen axis. The medical probe according to Embodiment 10. (12) The mechanical barrier further comprises an arm extending outwardly from the mechanical barrier perpendicular to the lumen axis, and the arm is configured to extend into a lumen defined by the elongated tube. The medical probe according to Embodiment 1. (13) The lumen is a first lumen disposed near a first end of the mechanical barrier, and the mechanical barrier further defines a second lumen extending through the arm near a second end of the mechanical barrier opposite the first end. The medical probe further comprises a fastener configured to extend at least partially into the second lumen to fix the mechanical barrier to the elongated tube when assembled with the elongated tube. The medical probe according to Embodiment 12. (14) The fastener a generally circular base having a first diameter, and A medical probe according to Embodiment 13, comprising a substantially cylindrical member having a second diameter, wherein the first diameter is larger than the second diameter, and the substantially cylindrical member extends outward from the substantially circular base. (15) The medical probe according to Embodiment 14, wherein the substantially cylindrical member is configured to be at least partially disposed within the second lumen.

[0068] (16) The medical probe according to Embodiment 14, wherein the substantially cylindrical member is further configured to be at least partially fixed within the second lumen via at least one of press-fitting, complementary thread features, soldering, welding, and adhesives. (17) The medical probe according to Embodiment 14, wherein the second lumen has a second lumen inner diameter, and the second lumen inner diameter is smaller than the inner diameter of the first lumen. (18) A medical device, an elongate tube extending along a longitudinal axis from a proximal end to a distal end, an actuator member extending along the elongate tube, an anchor member attached to the actuator member near the distal end of the elongate tube, wherein the actuator member and the anchor member are configured to deflect a deflectable tip of the elongate tube radially outward from the longitudinal axis during operation, a mechanical barrier disposed between the anchor member and the elongate tube, the mechanical barrier being configured to prevent the anchor member from damaging the elongate tube, comprising. (19) The mechanical barrier, a lumen extending through the mechanical barrier along a lumen axis and configured to receive at least a portion of the anchor member, An arm that extends outwardly from the mechanical barrier perpendicular to the lumen axis and is configured to extend into a lumen defined by the deflectable tip, and a medical device according to embodiment 18 defining the same. (20) The lumen is a first lumen, the lumen axis is a first lumen axis, the mechanical barrier further defines a second lumen that extends through the arm along a second lumen axis, and the mechanical barrier further comprises a fastener configured to extend at least partially into the second lumen to secure the mechanical barrier to the deflectable tip when assembled with the deflectable tip, a medical device according to embodiment 19.

Claims

1. A medical probe, comprising: an elongated tube extending along a longitudinal axis from a proximal end to a distal end; an actuator member extending along the elongated tube from substantially the proximal end to substantially the distal end; an anchor member attached to the actuator member near the distal end of the elongated tube; a mechanical barrier disposed between the anchor member and the elongated tube, the mechanical barrier having a lumen extending therethrough along a lumen axis; The lumen is configured to at least partially receive the anchor member. A medical probe.

2. The medical probe according to claim 1, wherein the mechanical barrier is disposed adjacent to the anchor member.

3. The medical probe according to claim 1, wherein the mechanical barrier is disposed distal to the anchor member.

4. The medical probe according to claim 1, wherein the anchor member comprises a ferrule extending along a ferrule axis and one or more extensions extending outwardly from the ferrule perpendicular to the ferrule axis.

5. The medical probe according to claim 1, wherein the actuator member comprises at least one of a pull wire or a rod.

6. The medical probe according to claim 1, wherein the mechanical barrier is configured to prevent the anchor member from damaging the elongated tube.

7. The medical probe according to claim 1, wherein the mechanical barrier further comprises one or more ledges extending outwardly from the mechanical barrier in a direction along the lumen axis, the one or more ledges being configured to assist in aligning the anchor member along the elongated tube when assembled with the mechanical barrier.

8. The medical probe according to claim 7, wherein the one or more ledges extend in a semi-circular circumferential direction around the lumen axis.

9. The medical probe further comprises: one or more wings extending outwardly from the mechanical barrier near a first end, the one or more wings being configured to fit into a recess defined by the elongated tube.

10. The medical probe according to claim 9, wherein the one or more wings extend outwardly from the mechanical barrier in a semi-circular shape.

11. The one or more wings comprise a first wing and a second wing, and the first wing is disposed on an opposite side of the second wing with respect to the lumen axis, the medical probe according to claim 10.

12. The mechanical barrier further comprises an arm extending outwardly from the mechanical barrier perpendicular to the lumen axis, and the arm is configured to extend into a lumen defined by the elongated tube, the medical probe according to claim 1.

13. The lumen is a first lumen disposed near a first end of the mechanical barrier, and the mechanical barrier further defines a second lumen extending through the arm near a second end of the mechanical barrier opposite the first end, and the medical probe further comprises a fastener configured to extend at least partially into the second lumen to fix the mechanical barrier to the elongated tube when assembled with the elongated tube, the medical probe according to claim 12.

14. The fastener comprises a substantially circular base having a first diameter, and a substantially cylindrical member having a second diameter, wherein the first diameter is larger than the second diameter, and the substantially cylindrical member extends outwardly from the substantially circular base, the medical probe according to claim 13.

15. The substantially cylindrical member is configured to be at least partially disposed within the second lumen, the medical probe according to claim 14.

16. The substantially cylindrical member is further configured to be at least partially fixed within the second lumen via at least one of press fitting, complementary thread features, soldering, welding, and adhesives, the medical probe according to claim 14.

17. The second lumen has a second lumen inner diameter, and the second lumen inner diameter is smaller than the inner diameter of the first lumen, the medical probe according to claim 14.

18. A medical device comprising an elongated tube extending along a longitudinal axis from a proximal end to a distal end, and an actuator member extending along the elongated tube, An anchor member attached to the actuator member near the distal end of the elongated tube, wherein the actuator member and the anchor member are configured to deflect the deflectable tip of the elongated tube radially outward from the longitudinal axis during actuation. The anchor member, A mechanical barrier disposed between the anchor member and the elongated tube, the mechanical barrier being configured to prevent the anchor member from damaging the elongated tube. The mechanical barrier, A medical device comprising.

19. The mechanical barrier is, A lumen extending through the mechanical barrier along the lumen axis and configured to receive at least a portion of the anchor member; An arm extending outwardly from the mechanical barrier perpendicular to the lumen axis and configured to extend into a lumen defined by the deflectable tip. The medical device according to claim 18, defining.

20. The lumen is a first lumen, the lumen axis is a first lumen axis, the mechanical barrier further defines a second lumen extending through the arm along a second lumen axis, and the mechanical barrier is configured to be at least partially disposed within the second lumen to secure the mechanical barrier to the deflectable tip when assembled with the deflectable tip. The medical device according to claim 19, further comprising a fastener.