CATHETER WITH ELECTRICALLY-ACTUATED ARTICULATION
20210322727 · 2021-10-21
Assignee
Inventors
Cpc classification
A61M25/0147
HUMAN NECESSITIES
A61M25/0158
HUMAN NECESSITIES
A61M25/0138
HUMAN NECESSITIES
A61B2090/3966
HUMAN NECESSITIES
International classification
Abstract
The present teachings provide an articulation catheter configured to be activated by electric energy. Specifically, one aspect of the present teachings provide a catheter body with a central axial lumen for delivering a medical device, and a plurality of peripheral lumens for articulation wires. The articulating wires join an energy source that controls the activation. The articulation wires are made of a conductive portion and an articulating portion made of shape memory material. The conductive portion of the articulating wire transfers electric energy to the articulating portion of the articulating wire. The articulating portion of the articulating wire transitions into its pre-programmed shape upon resistance heating caused by the electric energy received.
Claims
1. An articulation catheter system comprising: a catheter body having a proximal end, a distal end, an elongated axial central lumen extending from the proximal end to the distal end; at least one pair of peripheral lumens extending parallel to the elongated axial central lumen, wherein the at least one pair of peripheral lumens are positioned radially away from the elongated axial central lumen; at least one articulating wire extending inside a first peripheral lumen from a proximal end toward a distal end, making a U-turn, then extending inside a second peripheral lumen from a distal end toward a proximal end, with both ends of the at least one articulating wire extending outside of the proximal ends of the at least one pair of peripheral lumens; wherein the at least one articulating wire has a conductive portion and an articulating portion; an energy source connecting to the proximal ends of the articulating wire, wherein the conductive portion of the articulating wire conducts electric energy from the energy source to the articulating portion of the articulating wire, and wherein the articulating portion of the articulating wire is configured to change into a pre-programmed shape upon resistance heating when activated by the energy.
2. The articulating catheter system of claim 1, wherein the catheter body further comprises an articulating portion and a non-articulating portion, and wherein the articulating portion of the catheter body is configured to deflect according to the shape change of the articulating wire when activated by the energy.
3. The articulating catheter system of claim 2, wherein the articulating portion of the catheter body is positioned at a distal portion of the catheter body.
4. The articulating catheter system of claim 2, wherein the articulating portion of the catheter body further comprises a plurality of segments linked together by the articulating wire, wherein each segment has a central axial opening aligning with the elongated axial central lumen of the non-articulating portion of the catheter body, and multiple pairs of peripheral openings aligning with the peripheral lumens of the non-articulating portion of the catheter body.
5. The articulating catheter system of claim 1, wherein the catheter body further comprises multiple articulating portions separated by a non-articulating portion in between two articulating portions.
6. The articulating catheter system of claim 1, wherein the catheter body further comprises multiple pairs of peripheral lumens extending parallel to the longitudinal axial central lumen.
7. The articulation catheter system of claim 1 further comprising multiple articulating wires extending through the multiple pairs of peripheral lumens, wherein each articulating wire is configured to deflect different portions of the catheter body.
8. The articulating catheter system of claim 1, wherein the at least one articulating wire of the articulating catheter system is configured to bond along the peripheral lumen of the catheter body.
9. The articulating catheter system of claim 1, wherein the energy source of the articulating catheter system further includes a control which regulates the current applying to the articulating wire.
10. The articulating catheter system of claim 1, wherein the articulating wire of the articulating catheter system is configured to deflect to a greater amount at a higher current.
11. The articulating catheter system of claim 1, wherein the catheter body further comprises a distal cap fixed to the distal end of the catheter body, wherein the distal cap has at least one slot configured to be positioned over the at least one pair of peripheral lumen with the same articulating wire.
12. The articulating catheter system of claim 1, wherein the catheter body further comprises a distal recess, where a portion of the U-turn articulating wire positioned inside the distal recess.
13. An articulation catheter system comprising: a catheter body having a proximal end, a distal end, an elongated axial central lumen extending from the proximal end to the distal end; at least one articulating wire bonds along the external longitudinal surface of the catheter body, wherein the at least one articulating wire extends from the proximal end toward the distal end of the catheter body, making a U-turn, then extending from the distal end toward the proximal end of the catheter body, with both ends of the at least one articulating wire extending the proximal ends of the catheter body; wherein the at least one articulating wire has a conductive portion and an articulating portion; an energy source connecting to the proximal ends of the articulating wire, wherein the conductive portion of the articulating wire conducts electric energy from the energy source to the articulating portion of the articulating wire, and wherein the articulating portion of the articulating wire is configured to change into a pre-programmed shape upon resistance heating when activated by the energy.
14. The articulating catheter system of claim 14, wherein the catheter body further comprises an articulating portion and a non-articulating portion, and the articulating portion of the catheter body is configured to deflect according to the shape change of the articulating wire when activated by the energy.
15. The articulation catheter system of claim 14 further comprising multiple articulating wires bonding along an external longitudinal surface of the catheter body, wherein each articulating wire is configured to deflect different portions of the catheter body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
DETAILED DESCRIPTION
[0022] Certain specific details are set forth in the following descriptions and figures to provide an understanding of various embodiments of the present teachings. Those of ordinary skill in the relevant art would understand that they can practice other embodiments of the present teachings without one or more of the details described herein. Thus, it is not the intention of the applicant(s) to restrict or in any way limit the scope of the appended claims to such details. While various processes are described with reference to steps and sequences in the following disclosure, the steps, and sequences of steps should not be taken as required to practice all embodiments of the present teachings.
[0023] As used herein, the term “lumen” means a canal, a duct, or a generally tubular space or cavity in the body of a subject, including veins, arteries, blood vessels, capillaries, intestines, and the like. The term “lumen” can also refer to a tubular space in a catheter, a sheath, a hollow needle, a tube, or the like.
[0024] As used herein, the term “proximal” shall mean close to the operator (less into the body) and “distal” shall mean away from the operator (further into the body). In positioning a medical device inside a patient, “distal” refers to the direction relatively away from a catheter insertion location and “proximal” refers to the direction relatively close to the insertion location.
[0025] As used herein, the terms “radially outward” and “radially away” means any direction which is not parallel with the central axis. For example, considering a cylinder, a radial outward member could be a piece of wire or a loop of wire that is attached or otherwise operatively coupled to the cylinder that is oriented at an angle greater than 0° relative to the central longitudinal axis of the cylinder.
[0026] As used herein, the term “wire” can be a strand, a cord, a fiber, a yarn, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
[0027] As used herein, the term “sheath” may also be described as a “catheter” and, thus, these terms can be used interchangeably.
[0028] Unless otherwise specified, all numbers expressing quantities, measurements, and other properties or parameters used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless otherwise indicated, it should be understood that the numerical parameters set forth in the following specifications and appended claims are approximations. At the very least and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, numerical parameters should be read in light of the number of reported significant digits and the application of ordinary rounding techniques.
[0029] It will be understood that the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
[0030] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.
[0031] It will be further understood that when an element is referred to as being “on”, “attached”, “connected” or “coupled” to another element, it can be directly on or above, or connected or coupled to, the other element or one or more intervening elements can be present. In contrast, when an element is referred to as being “directly on”, “directly attached”, “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).
[0032] It will be further understood that when a first element is referred to as being “in”, “on” and/or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.
[0033] Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as “below” and/or “beneath” other elements or features would then be oriented “above” the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
[0034] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence.
[0035] The term “and/or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example “A and/or B” is to be taken as specific disclosure of each of (i) A, (ii) B, and (iii) A and B, just as if each is set out individually herein.
[0036] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross-section, such as the cross-section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross-section of the component being described.
[0037] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.
[0038] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.
[0039] The present teachings relate to an articulation catheter shaft design with the ability to be activated remotely. According to one embodiment, such catheter shaft having a single lumen with a plurality of articulation points. According to one embodiment of the present teaching, the disclosed catheter configuration offers excellent distal flexibility, an outstanding proximal pushability and torquability, superior external lubricity, and superior internal surface lubricity.
[0040]
[0041] According to one embodiment of the present teachings, the catheter body (12) has a uniform diameter throughout its entire length. In one embodiment, the catheter body (12) has a diameter of 0.040-0.400 inches and an overall length of 5-110 inches. In one embodiment, the non-articulating portion of the catheter body could be 5-100 inches long and the articulating portion of the catheter body would 0.5-10 inches long. In another embodiment, the diameter of the catheter body (12) varies along its longitudinal length. In one exemplary embodiment, the diameter of the catheter body (12) gradually reduces from its proximal end (16) toward its distal end (14). In another exemplary embodiment, a proximal portion of the catheter body (12) has a first larger diameter, a distal portion of the catheter body (12) has a second smaller diameter, and the diameter of the intermediate portion in between the proximal and distal portions of the catheter body (12) which gradually reduces from the first diameter to the second diameter. One skilled in the art should recognize that the catheter body (12) could have more diameter profile across multiple portions of its entire length, thus exemplary embodiment shown and described above should not be viewed as limiting to the scope of the present teaching.
[0042] According to one embodiment of the present teaching, the catheter body (12) could have a unity construction such as manufactured via multiple lumen extrusion technique. In an alternative embodiment, the catheter body (12) could have multiple-step construction. For example, the central axial lumen (20) of the catheter body (12) could be made of one tubing, and the multiple peripheral lumens made of separate tubing; all tubings are then composited together through known techniques in the industry. According to another embodiment, the catheter body (12) could further include other layers, such as mesh layer made of metal wires to improve kink resistance, and/or additional surface layer in order to improve surface smoothness for better vascular insertion. One skilled in the art should understand exemplary embodiment described herein should not be viewed as limiting to the scope of the present teaching.
[0043] According to one embodiment, the catheter body (12) could be made from a flexible polymer such as Nylon, PEBAX, Polyurethane, silicone, or other material known in the field. According to one embodiment of the present teachings, a radioopaque marker is used to make the catheter body (12) visible using radiographic imaging equipment such as X-ray, magnetic resonance, ultrasound or other imaging techniques. Markers may be applied to any part of the catheter body (12) by sewing, adhering, swaging, and etc. The radioopaque markers may be formed of tantalum, tungsten, platinum, irridium, gold, alloys of these materials, or other materials that are known to those skilled in the art. In an alternative embodiment, the catheter body (12) could be made of materials blended with radiopaque compound, such as Barium Sulfate, Bismuth, Tungsten, so that the entire length of the catheter body (12) could be visible through imaging equipment.
[0044] According to one embodiment of the present teachings, only the distal portion of the catheter could articulate once activated. In an alternative embodiment, any portion of the catheter can articulate upon activation. According to one embodiment of the present teachings, the articulating portion of the catheter is made of the same material as the rest portion of the catheter. In an alternative embodiment, the articulating portion of the catheter is made of a different material from the rest portion of the catheter. Yet, in another embodiment of the present teaching, the material used for the articulating portion of the catheter is configured to stretch and compression easily in order to accommodate the shape change of the portion of the catheter.
[0045] Now referring back to
[0046] The peripheral lumens (22) are positioned evenly around the central axial lumen (20) as shown in
[0047] In one embodiment, the diameter of the peripheral lumen is 0.04-0.4000 inches. According to another embodiment, the diameter of the peripheral lumen is 1-100% of the central axial lumen (20). In another embodiment, the diameter of the all peripheral lumens (22) are the same. In another embodiment, at least one peripheral lumen has a different diameter than the rest of the peripheral lumens (22). According to an alternative embodiment, the central axial lumen (20) is sized with a larger diameter than all the peripheral lumens (22). In another embodiment, the central axial lumen (20) is sized with the same diameter as at least one peripheral lumen.
[0048] Now referring back to
[0049] According to one embodiment of the present teaching, the articulating portion of the wire (30) could be made of shape memory which would change its shape once heated to a pre-defined temperature. For example, the articulating portion of the wire (30) could be made of copper-aluminum-nickel and nickel-titanium (NiTi). Specifically, the articulating portion of the wire (30) could be made of nitinol material. According to one embodiment, the articulating portion of the wire (30) is pre-shaped at a pre-defined temperature through means known by those skilled in the art. Thus, when the energy transmits through the articulating portion, the wire is heated to a pre-defined temperature, and then automatically transitions into its pre-defined shape, which transforms the catheter body (12) into a controlled bend/or deflection. In another embodiment, the conductive portion of the wire (30) could be made of any conductive metal or alloy. In an alternative embodiment, the conductive portion of the wire (30) could be other made of other type of conductive elements, such as a conductive thin film. According to one embodiment of the present teachings, the articulating wire (30) could have an overall diameter of 0.002-0.100 inches. In an alternative exemplary embodiment, the conductive thin film could have a thickness of 1-1000 microns.
[0050] Now referring back to
[0051] In an alternative embodiment, the articulating wire could be built into the catheter body via many known manufacturing method, such as wire extrusion method. In such way, the articulating wire is fed into the extruder that makes the catheter body. In another embodiment, the articulating wire could be positioned outside of the elongated catheter body. According to one embodiment of the present teaching, the articulating element and/or wire could be bond along the external longitudinal surface of the catheter bond via thermal, chemical or mechanical means. Articulating catheter built with such methods, wire extrusion, or bonded to the external longitudinal surface of the catheter body, would not have peripheral lumens as described herein.
[0052] Now referring back to
[0053] According to one embodiment of the present teachings, in order to prevent the articulating wire (30) from protruding outside of the distal end (14) of the catheter body (12), such as the exemplary embodiment shown in
[0054]
[0055]
[0056] According to one embodiment of the present teachings, the catheter body (12) could be made entirely of segments (72). According to another embodiment, only a distal portion of the catheter body (12) is made of a plurality of segments (72), as shown in
[0057] Now referring to
[0058] According to one embodiment, the articulating mechanism of the present teachings includes having multiple articulating wires (30) that extend along the entire longitudinal length of the catheter body (12) as shown in
[0059] The present invention discloses an articulation catheter with its articulating mechanism activated by means of electric energy. Since, such articulating mechanism can be initiated by a simpler control such as a foot pedal, it would give a clinician greater freedom in other task, such as implant delivery/deployment and etc. However, one skilled in the art should understand that the presently disclosed energy-deflecting mechanism may be combined with mechanical articulating mechanism in order to satisfy the needs of a variety of surgical procedures.
[0060] The foregoing description and accompanying drawings set forth a number of examples of representative embodiments at the present time. Various modifications and alternative designs will become apparent to those skilled in the art in light of the foregoing teachings without departing from the spirit hereof, or exceeding the scope hereof, which is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope. Additionally, the present teachings are capable of other embodiments or of being practiced or carried out in various other ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
[0061] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present teachings belong. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present teachings. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.