The present invention relates generally to medical devices, and in particular, devices for catheters that can cause the distal end of the catheter to deflect away from a longitudinal axis.
Catheter devices are commonly used in medical procedures when medical devices must reach organs, tissue, or other difficult-to-reach portions of a patient's body. Typically, catheters include a flexible tube or shaft that is inserted through a patient's vascular system or other regions and navigated to the target location. To help guide the catheter to the target location, catheters often include a flexible distal tip that can be articulated to help navigate the catheter through the patient's vascular system. Often, the articulation systems include a puller wire or a push rod that is anchored near a distal end of the flexible tube or shaft and is connected to an actuator on a handle operated by a medical professional. When the medical professional actuates the actuator to pull the puller wire proximally or push the push rod distally, the flexible distal tip articulates in a predetermined direction (i.e., bends away from the longitudinal axis of the flexible tube).
Some existing catheter articulation systems include anchor members that are configured to connect the distal end of the flexible tube to either the puller wire or the push rod. Some existing anchor members, however, may cut into or otherwise damage the flexible tube if too much tension or pressure is applied to the puller wire or push rod. When this happens, the puller wire or push rod may become ineffective to cause the flexible distal tip to articulate.
Accordingly, there is a need in the art for articulation systems that are configured to help prevent the likelihood that the anchor member damages the flexible tube. These and other issues can be addressed by the technology disclosed herein.
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.
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 anchor member can be configured to cause a deflectable tip of the elongated tube to deflect radially outward from the longitudinal axis when actuated. 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.
The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
The disclosed technology includes devices for catheter articulation systems that can help to prevent anchor members from damaging the flexible tube. Furthermore, the devices described herein can help to better secure the anchor to the distal end of the flexible tube and can provide leverage to the distal end of the flexible tube to help cause the distal end of the flexible tube to deflect away from the longitudinal axis when the puller wire or push rod is actuated. The disclosed technology includes various designs for mechanical barriers that can be disposed between the anchor and the 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 the anchor from damaging the flexible tube.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g., “about 90%” may refer to the range of values from 71% to 110%.
As used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment. In addition, vasculature of a “patient,” “host,” “user,” and “subject” can be vasculature of a human or any animal. It should be appreciated that an animal can be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like). It should be appreciated that the subject can be any applicable human patient, for example. As well, the term “proximal” indicates a location closer to the operator or physician whereas “distal” indicates a location further away to the operator or physician.
As discussed herein, “physician”, “operator”, or “medical professional” can include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.
As discussed herein, the term “ablate” or “ablation”, as it relates to the devices and corresponding systems of this disclosure, refers to components and structural features configured to reduce or prevent the generation of erratic cardiac signals in the cells by utilizing energy delivered to the tissue. These techniques can include ablation techniques such as irreversible electroporation (IRE), radio frequency (RF) ablation, and cryoablation.
Reference is made to
Catheter 14 is an exemplary catheter that includes an end effector 28 comprising one and preferably multiple electrodes 26 optionally distributed over an expandable assembly and a distal tip of end effector 28 and configured to detect electro-physiological signals and/or deliver ablative energy to tissue. Catheter 14 is shown as being a lasso catheter in
Catheter 14 may additionally include a magnetic-based position sensor embedded in or near end effector 28 for tracking position and orientation of end effector 28. The end effector 28 can further include one or more impedance-based electrodes disposed in or near end effector 28 for tracking position and orientation of end effector 28.
Magnetic-based position sensor may be operated together with a location pad 25 including a plurality of magnetic coils 32 configured to generate magnetic fields in a predefined working volume. Real time position of end effector 28 of catheter 14 may be tracked based on magnetic fields generated with location pad 25 and sensed by magnetic-based position sensor 29. The magnetic-based position sensor can be a single axis sensor, a dual axis sensor, or a triple axis sensor depending on the particular configuration. Details of the magnetic based position sensing technology are described in U.S. Pat. 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 set forth fully herein.
System 10 includes one or more electrode patches 38 positioned for skin contact on patient 23 to establish location reference for location pad 25 as well as tracking of impedance-based electrodes. For impedance-based tracking, electrical current is directed toward impedance-based electrodes and sensed at electrode skin patches 38 so that the location of each electrode can be triangulated via the electrode patches 38. Details of the impedance-based location tracking technology are described in U.S. Pat. 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 set forth fully herein.
A recorder 11 displays electrograms 21 captured with body surface ECG electrodes 18 and intracardiac electrograms (IEGM) captured with electrodes of catheter 14. Recorder 11 may include pacing capability for pacing the heart rhythm and/or may be electrically connected to a standalone pacer.
System 10 may include an ablation energy generator 50 that is adapted to conduct ablative energy to one or more electrodes disposed on the end effector and configured for delivering ablative energy to tissue. Energy produced by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including monopolar or bipolar high-voltage DC pulses as may be used to effect irreversible electroporation (IRE), or combinations thereof.
Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiological equipment, power supply and a workstation 55 for controlling operation of system 10. Electrophysiological equipment of system 10 may include for example, multiple catheters, location pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 additionally includes processing capability for implementing real-time computations of location of the catheters and for performing ECG calculations.
Workstation 55 includes memory, processor unit with memory or storage with appropriate operating software loaded therein, and user interface capability. Workstation 55 may provide multiple functions, optionally including (1) modeling the endocardial anatomy in three-dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27, (2) displaying on display device 27 activation sequences (or other data) compiled from recorded electrograms 21 in representative visual indicia or imagery superimposed on the rendered anatomical map 20, (3) displaying real-time location and orientation of multiple catheters within the heart chamber, and (4) displaying on display device 27 sites of interest such as places where ablation energy has been applied. One commercial product embodying elements of the system 10 is available as the CARTO™ 3 System, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.
The mechanical barrier 100 can include a body 110 extending from a first end 112 to a second end 114. The body 110 can be made of a suitable biocompatible material having a hardness that is greater than the elongated tube 131. The body 110 can define a lumen 120 extending through the body 110 near the first end 112 and an arm 116 extending outwardly toward the second end 114. The lumen 120 can have an inner diameter 122 and the body 110 form a circular end near the first end 112 defining an outer diameter 124. The outer diameter 124 can be greater than the inner diameter 122. The body 110 can further include rounded edges 111 to reduce the likelihood that the mechanical barrier 100 will damage the elongated tube 131. The body 110 can be sized as shown in
The anchor member 130 can be configured to attach to a pull wire or a push rod (not shown). For example, the anchor member 130 can comprise a ferrule 132 that can be crimped, soldered, adhered, or otherwise attached to the pull wire or push rod such that when a medical professional actuates the pull wire or push rod, the force applied to the pull wire or push rod will be distributed to the anchor member 130 and, consequently, to the deflectable tip 140. The anchor member 130 can further include one or more extensions 134 extending outwardly from the ferrule 132 to prevent the anchor member 130 from being pulled back through a lumen of the elongated tube 131. The anchor member 130 can further include one or more pads 135 attached to the extensions 134 to help prevent further damage by the anchor member 130 as is it pulled proximally or pushed distally.
As shown in
The elongated tube 131, in the example shown in
The methods just described can be used with the devices and features described herein. The methods are offered for illustrative purposes and should not be construed as limited to include only the elements described herein and can include alternative orders of steps and/or intervening steps not described herein.
The disclosed technology described herein can be further understood according to the following clauses:
Clause 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 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 comprising a lumen extending through the mechanical barrier along a lumen axis, the lumen configured to at least partially receive the anchor member.
Clause 2: The medical probe of clause 1, the mechanical barrier being disposed proximate the anchor member.
Clause 3: The medical probe of clause 1, the mechanical barrier being disposed distal the anchor member.
Clause 4: The medical probe of clause 1, the anchor member comprising a ferrule extending along a ferrule axis and one or more extensions extending outward from the ferrule perpendicular to the ferrule axis.
Clause 5: The medical probe of clause 1, the actuator member comprising at least one of a puller wire or a rod.
Clause 6: The medical probe of clause 1, the mechanical barrier being configured to prevent the anchor member from damaging the elongated tube.
Clause 7: The medical probe of clause 1, the mechanical barrier further comprising one or more ledges extending outward from the mechanical barrier in a direction along the lumen axis, the one or more ledges configured to help align the anchor member along the elongated tube when assembled together with the mechanical barrier.
Clause 8: The medical probe of clause 7, the one or more ledges extending semi-circumferentially about the lumen axis.
Clause 9: The medical probe of clause 1, the medical probe further comprising: one or more wings extending outward from the mechanical barrier near a first end, the one or more wings configured to fit within a recess defined by the elongated tube.
Clause 10: The medical probe of clause 9, the one or more wings extending outwardly from the mechanical barrier in a semi-circular shape.
Clause 11: The medical probe of clause 10, the one or more wings comprising a first wing and a second wing, the first wing disposed opposite the second wing with respect to the lumen axis.
Clause 12: The medical probe of clause 1, the mechanical barrier further comprising an arm extending outwardly from the mechanical barrier perpendicular to the lumen axis, the arm configured to extend into a lumen defined by the elongated tube.
Clause 13: The medical probe of clause 12, the lumen being a first lumen disposed near a first end of the mechanical barrier, the mechanical barrier further defining a second lumen extending through the arm near a second end of the mechanical barrier opposite the first end, the medical probe further comprising a fastener configured to extend at least partially into the second lumen to secure the mechanical barrier to the elongated tube when assembled with the elongated tube.
Clause 14: The medical probe of clause 13, the fastener comprising: a generally circular base comprising a first diameter; and a generally cylindrical member comprising a second diameter, the first diameter being greater than the second diameter and the generally cylindrical member extending outwardly from the generally circular base.
Clause 15: The medical probe of clause 14, the generally cylindrical member being configured to be disposed at least partially within the second lumen.
Clause 16: The medical probe of clause 14, the generally cylindrical member being further configured to be secured at least partially in the second lumen via at least one of a press fit, complementary threaded features, soldering, welding, and adhesive.
Clause 17: The medical probe of clause 14, the second lumen comprising a second lumen inner diameter, the second lumen inner diameter being less than an inner diameter of the first lumen.
Clause 18: A medical device 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; an anchor member attached to the actuator member near the distal end of the elongated tube, the actuator member and anchor member configured to cause a deflectable tip of the elongated tube to deflect radially outward from the longitudinal axis when actuated; and a mechanical barrier disposed between the anchor member and the elongated tube, the mechanical barrier configured to prevent the anchor member from damaging the elongated tube.
Clause 19: The medical device of clause 18, the mechanical barrier defining: a lumen extending through the mechanical barrier along a lumen axis, the lumen configured to receive at least a portion of the anchor member; and an arm extending outwardly from the mechanical barrier perpendicular to the lumen axis, the arm configured to extend into a lumen defined by the deflectable tip.
Clause 20: The medical device of clause 19, the lumen being a first lumen and the lumen axis being a first lumen axis, the mechanical barrier further defining a second lumen extending through the arm along a second lumen axis, the mechanical barrier further comprising 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.
The embodiments described above are cited by way of example, and the present invention is not limited by what has been particularly shown and described hereinabove. Rather, the scope of the invention includes both combinations and sub combinations of the various features described and illustrated hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
The present application is a continuation-in-part application of U.S. patent application Ser. No. 18/397,675, filed Dec. 27, 2023 (Attorney Docket #: 253757.000415-BIO6878USNP1), the entire contents of each of which is incorporated herein by reference in its entirety as if fully set forth herein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18397675 | Dec 2023 | US |
| Child | 18433765 | US |