CN220655661U - Irrigation hub for medical probe and medical probe - Google Patents

Irrigation hub for medical probe and medical probe Download PDF

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Publication number
CN220655661U
CN220655661U CN202321007929.8U CN202321007929U CN220655661U CN 220655661 U CN220655661 U CN 220655661U CN 202321007929 U CN202321007929 U CN 202321007929U CN 220655661 U CN220655661 U CN 220655661U
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China
Prior art keywords
irrigation
longitudinal axis
hub
medical probe
electrodes
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Active
Application number
CN202321007929.8U
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Chinese (zh)
Inventor
C·T·比克勒
J·T·凯斯
K·M·奥卡斯基
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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Priority claimed from US18/192,361 external-priority patent/US20230346465A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002Irrigation

Abstract

The disclosed technology includes a medical probe and an irrigation hub for the medical probe that includes a cylindrical member extending along a longitudinal axis. The cylindrical member may include a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion, a distal end having a second outer diameter less than the first outer diameter, and a flush inlet chamber disposed proximate the interior portion and configured to receive fluid from a flush supply. The cylindrical member may also include a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis and a diverter extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.

Description

Irrigation hub for medical probe and medical probe
Citation of related application
The present application claims priority benefits from prior filed U.S. provisional patent application 63/336,023 filed on 28 of 4 months 2022 (attorney docket number: BIO6675USPSP 1), prior filed on 28 of 4 months 2023 (attorney docket number: BIO6693USPSP 1), and prior filed U.S. provisional patent application 63/477,819 filed on 29 of 12 months 2022 (BIO 6794USPSP 1), each of which is hereby incorporated by reference in its entirety as if fully set forth herein.
Technical Field
The present utility model relates generally to medical devices, and in particular to medical probes with irrigation, and further but not exclusively to medical probes configured to provide irrigation to electrodes.
Background
Arrhythmia, such as Atrial Fibrillation (AF), may occur when areas of heart tissue abnormally conduct electrical signals to adjacent tissue. This can disrupt the normal cardiac cycle and lead to arrhythmia. Certain protocols are used to treat cardiac arrhythmias, including surgically disturbing the source of the signals responsible for the arrhythmia and disturbing the conduction pathways for such signals. By selectively ablating cardiac tissue by applying energy through the catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one portion of the heart to another.
Many current ablation methods in the art utilize Radio Frequency (RF) electrical energy to heat tissue. RF ablation may have certain risks associated with thermal heating that may lead to charring of tissue, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulae.
Cryoablation is an alternative to RF ablation, which generally reduces the thermal risk associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; thus, cryoablation is not feasible in certain anatomical geometries that may be reached by an electrical ablation device.
Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods. IRE delivers short pulses of high pressure to the tissue and produces unrecoverable cell membrane permeabilization. The use of multi-electrode probes to deliver IRE energy to tissue has previously been proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. patent publications 2021/0169550A1, 2021/0169567A1, 2021/0169568A1, 2021/0161592A1, 2021/0196372A1, 2021/0177503A1 and 2021/0186604A1, each of which is incorporated herein by reference and in the appendix hereof.
Ablation of tissue may result in localized temperature increases near the electrodes. Accordingly, many existing ablation catheters include irrigation elements configured to deliver irrigation to an area proximate to the electrode. For example, some existing ablation catheters are configured to deliver saline to an area proximate to an electrode. Unfortunately, many existing irrigation elements are designed with sharp bends or otherwise inefficient designs, which can reduce the effectiveness of the cooling provided by the irrigation element. Accordingly, there is a need in the art for a flushing element that increases the effectiveness of the cooling provided by the flushing element.
Disclosure of Invention
According to one example of the present utility model, an irrigation hub for an ablation catheter is provided. The irrigation hub may include a cylindrical member extending along a longitudinal axis. The cylindrical member may include a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion, a distal end having a second outer diameter less than the first outer diameter, and a flush inlet chamber disposed proximate the interior portion and configured to receive fluid from a flush supply. The cylindrical member may also include a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis and a diverter extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
The disclosed technology may include a medical probe including a tubular shaft extending along a longitudinal axis of the medical probe, a plurality of ridges configured to curve radially outward from the longitudinal axis, and a plurality of electrodes. Each electrode of the plurality of electrodes may be attached to a spine of the plurality of spines. The medical probe may also include an irrigation hub attached to the tubular shaft and configured to receive and support the plurality of ridges. The irrigation hub may include a cylindrical member extending along the longitudinal axis and including a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an inner portion and a distal end having a second outer diameter. The second outer diameter may be smaller than the first outer diameter. The cylindrical member may include: a flush inlet chamber disposed proximate the inner portion and configured to receive fluid from a flush supply line separate from the tubular shaft to prevent fluid from immersing in the tubular shaft; a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis; and a shunt extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
Additional features, functions, and applications of the disclosed technology are discussed in more detail herein.
Drawings
FIG. 1 is a schematic illustration of a medical system including a medical probe having electrodes in accordance with the disclosed technology;
FIG. 2 is a schematic illustration showing a perspective view of a medical probe having an electrode in an expanded form in accordance with the disclosed technology;
FIG. 3 is a schematic illustration showing an exploded view of a medical probe in accordance with the disclosed technology;
FIG. 4A is a schematic illustration showing a top perspective view of a flush hub in accordance with the disclosed technology;
FIG. 4B is a schematic illustration showing a bottom perspective view of a flush hub in accordance with the disclosed technology;
FIG. 5A is a schematic illustration showing a side view of a flushing hub in accordance with the disclosed technology;
FIG. 5B is a schematic illustration showing a top view of a flush hub in accordance with the disclosed technology;
FIG. 5C is a schematic illustration showing a bottom view of a flush hub in accordance with the disclosed technology;
FIG. 6 is a schematic illustration showing a cross-sectional view of a flush hub in accordance with the disclosed technology;
FIG. 7 is a schematic illustration showing fluid flow through a flush hub in accordance with the disclosed technology;
FIG. 8A is a schematic illustration showing a perspective view of another exemplary medical probe in an expanded form and having electrodes in accordance with another example of the disclosed technology; and is also provided with
Fig. 8B is a schematic illustration showing a perspective view of the medical probe of fig. 8A showing ridges in accordance with the disclosed technology.
Detailed Description
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict selected examples and are not intended to limit the scope of the utility model. The detailed description illustrates by way of example, and not by way of limitation, the principles of the utility model. This description will clearly enable one skilled in the art to make and use the utility model, and describes several embodiments, adaptations, variations, alternatives and uses of the utility model, including what is presently believed to be the best mode of carrying out the utility model.
As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose thereof as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited values, for example "about 90%" may refer to a range of values of 71% to 110%. In addition, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but use of the subject utility model in a human patient represents a preferred embodiment. Likewise, the term "proximal" refers to a location closer to an operator or physician, while "distal" refers to a location further from the operator or physician.
As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" may be the vasculature of a human or any animal. It should be understood that the animal may be of any suitable type including, but not limited to, a mammal, a veterinary animal, a livestock animal or a companion animal, and the like. For example, the animal may be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain characteristics similar to humans. It should be appreciated that the subject may be, for example, any suitable human patient.
As discussed herein, a "physician" may include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery meter device associated with delivering a multi-electrode catheter for treating drug refractory atrial fibrillation to a subject.
As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy, such as reversible or irreversible electroporation (IRE), interchangeably referred to in the present disclosure as Pulsed Electric Field (PEF) and Pulsed Field Ablation (PFA), or thermal energy, such as Radio Frequency (RF) ablation or cryoablation. "ablation" as used throughout this disclosure, when referring to the devices and corresponding systems of this disclosure, refers to thermal or non-thermal ablation of cardiac tissue for certain conditions, including, but not limited to, arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices and systems that implement various forms of body tissue ablation as understood by those skilled in the relevant art.
As discussed herein, the terms "tubular" and "tube" are to be understood in a broad sense and are not limited to structures that are right circular cylinders or that are entirely circumferential in cross-section or have a uniform cross-section throughout their length. For example, the tubular structure is generally shown as a substantially right circular cylinder structure. However, the tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.
Fig. 1 illustrates an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 into a chamber or vascular structure of the heart 12 through the vascular system of a patient 23. Typically, the delivery sheath catheter is inserted into the left atrium or the right atrium near the desired location in the heart 12. Multiple catheters may then be inserted into the delivery sheath catheter in order to reach the desired location. The plurality of catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and/or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal tip of the catheter 14 (i.e., the basket catheter 28 in this case) into contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.
The catheter 14 is an exemplary catheter comprising one (preferably multiple) electrodes 26 optionally distributed over multiple ridges 22 at a basket catheter 28 and configured to sense IEGM signals. Catheter 14 may additionally include a position sensor 29 embedded in or near basket catheter 28 for tracking the position and orientation of basket catheter 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor comprising three magnetic coils for sensing three-dimensional (3D) position and orientation.
The combined magnetic-based position sensor and force sensor 68 is operable with a placemat 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of basket catheter 28 of catheter 14 may be tracked based on the magnetic field generated with location pad 25 and sensed by magnetic-based position sensor 29. Details of magnetic-based position sensing techniques 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, 6,892,091, each of which is incorporated herein by reference and in the appendices thereto.
The system 10 includes one or more electrode patches 38 that are positioned in contact with the skin of the patient 23 to establish a positional reference for impedance-based tracking of the location pad 25 and the electrode 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based location 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 by reference herein and in the appendix attached hereto.
Recorder 11 displays an electrogram 21 captured with body surface ECG electrodes 18 and an Intracardiac Electrogram (IEGM) captured with electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and/or may be electrically connected to a separate pacemaker.
The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at a distal tip of a catheter configured for ablation. The energy generated by ablation energy generator 50 may include, but is not limited to, radio Frequency (RF) energy or Pulsed Field Ablation (PFA) energy, including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE), or a combination thereof.
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 for controlling operation of the system 10. The electrophysiological equipment of system 10 can include, for example, a plurality of catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing power for enabling real-time calculation of the position of the catheter and for performing ECG calculations.
The workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 may provide a number of functions, optionally including: (1) Three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) Displaying the activation sequence (or other data) compiled from the recorded electrogram 21 on the display device 27 with a representative visual marker or image superimposed on the rendered anatomical map 20; (3) Displaying real-time positions and orientations of a plurality of catheters within a heart chamber; and (5) displaying a site of interest (such as a site to which ablation energy has been applied) on the display device 27. A commodity embodying elements of system 10 may be CARTO TM System 3 was purchased from Biosense Webster, inc.,31TechnologyDrive,Suite 200,Irvine,CA 92618,USA.
Fig. 2 is a schematic illustration showing a perspective view of a basket catheter 28 with an electrode 26 attached to a spine 22, shown in expanded form, for example by being pushed out of a tubular shaft lumen at the distal end of an insertion tube, in accordance with an embodiment of the present utility model. As shown in fig. 2, the basket catheter 28 includes a plurality of flexible ridges 22 formed at and connected at the ends of the tubular shaft 62. The ridges 22 may be configured to curve radially outward from a longitudinal axis 60 passing through the basket conduit 28. During a medical procedure, physician 24 may deploy basket catheter 28 by extending tubular shaft 62 from the insertion tube, thereby causing basket catheter 28 to exit the insertion tube and transition to an expanded form. The ridges 22 may have an oval (e.g., circular) or rectangular (which may appear flat) cross-section and comprise a flexible, resilient material (e.g., a shape memory alloy such as nitinol, also known as nitinol) that forms struts.
The physician 24 may contact the basket catheter 28 with tissue to perform an ablation procedure. When ablation energy is output by electrode 26, electrode 26 and nearby tissue may begin to be heated. To help dissipate heat generated by the electrode 26, the disclosed techniques may include a flushing hub 100 that may be configured to deliver fluid near the electrode 26 to cool the electrode 26 and prevent thrombosis, as will be described in more detail herein.
As shown in fig. 2 and 3, the basket catheter 28 may be attached to the tubular shaft 62 by a coupler 64 and a sleeve 66 positioned between the tubular shaft 62 and the basket catheter 28. Additionally, a combined magnetic-based position sensor and force sensor 68 may be positioned between the tubular shaft 62 and the basket catheter 28 and configured to detect forces applied to the basket catheter 28. The combination sensor 68 may be at least partially disposed within the sleeve 66.
Fig. 4A is a schematic illustration showing a top perspective view of a washing hub 100 in accordance with the disclosed technology, and fig. 4B is a schematic illustration showing a bottom perspective view of the washing hub 100 in accordance with the disclosed technology. As previously mentioned, and as will be described in greater detail herein, the irrigation hub 100 may be configured to deliver fluid to the electrode 26 of the basket catheter 28. As shown in fig. 4A, the irrigation hub 100 may include a cylindrical member 102 including a proximal end 103a and a distal end 103b. As shown, the proximal end 103a may have a larger outer diameter than the distal end 103b.
The irrigation hub 100 may include a plurality of irrigation openings 104, which may be configured to allow fluid to flow therethrough and to help direct fluid outwardly from the irrigation hub 100. The irrigation openings 104 may be radially dispersed about the distal end 103b and generally transverse to the longitudinal axis 60. The rinse openings 104 may each be formed with a hole having an inlet region 105a smaller than an outlet region 105b, allowing fluid to disperse outwardly when directed out of the rinse openings 104. In other words, as fluid flows through the irrigation hub 100 and out of the irrigation openings 104, the inlet region 105a through which fluid first flows through the irrigation openings will be smaller than the outlet region 105b through which fluid flows just prior to exiting the irrigation hub 100. In this way, the irrigation hub 100 may help direct or channel irrigation fluid outwardly from the irrigation hub 100 toward the electrode 26 or otherwise.
The irrigation hub 100 may also include a plurality of release lands 106, which may be configured to receive and assist in retaining the ridges 22. As shown in fig. 3, the ridges 22 may each include a connection end 31 that may be configured to be at least partially inserted into the release table 106 such that the ridges 22 may be secured in place when assembled with the irrigation hub 100.
The irrigation hub 100 may also include a sensor mount 108, which may be disposed at the distal end 103b of the cylindrical member 102. The sensor mount 108 may be configured to receive and support one or more sensors 70, 608 (see fig. 2 and 6) of a medical probe. In some examples, the sensor may be a reference electrode configured to detect far-field signals, which may be used to process and filter signals detected by electrode 26 when, for example, electrode 26 is used to map electrical signals dispersed through tissue. In other examples, the sensor may be or include one or more magnetic position sensors that may be used to detect magnetic fields output by one or more magnetic field generators to determine the position and/or orientation of the basket catheter 28.
As shown in fig. 4B, the proximal end 103a of the cylindrical member 102 may include a recess extending inwardly along the longitudinal axis and forming an inner portion 111. The irrigation hub 100 may also include an irrigation coupling 110, which may be configured to receive or otherwise connect to an irrigation supply tube 200 (shown in fig. 7). The cylindrical member 102 can also include an irrigation inlet chamber 112, which can be disposed distally of the irrigation coupling 110 and can be configured to receive fluid from the irrigation supply tube 200. Irrigation supply tube 200 may fluidly separate the fluid from inner portion 111, combination sensor 68, tubular shaft 62, and other components of the medical probe. In other words, fluid may be delivered to the flush inlet chamber 112 via the flush supply tube 200 without the fluid coming into contact with other internal components of the medical probe. The flush inlet chamber 112 may be sized to receive a sufficient amount of fluid from the flush supply tube 200 such that the flow of fluid is generally unobstructed. In some examples, the flush inlet chamber 112 may have an inner diameter equal to the inner diameter of the flush supply tube 200. The flush inlet chamber 112 may be fluidly connected to the plurality of flush openings 104 such that fluid may flow through the flush inlet chamber 112 and be directed out of the plurality of flush openings 104.
The irrigation hub 100 may also include a plurality of attachment mechanisms 114, which may be configured for attaching the irrigation hub 100 to the combination sensor 68 and/or the tubular shaft 62. The attachment mechanism 114 may be, for example, but not limited to, a bayonet mount, a snap connector, a threaded fitting, or other suitable type of attachment mechanism 114 for a particular application.
Fig. 5A-5C illustrate various views of the irrigation hub 100. In particular, fig. 5A shows a side view of the irrigation hub 100, fig. 5B shows a top view of the irrigation hub, and fig. 5C shows a bottom view of the irrigation hub, in accordance with the disclosed technology. Each of the reference numerals shown in fig. 5A-5C corresponds to various components and/or features described herein.
Fig. 6 shows a cross-sectional view of the irrigation hub 100 in accordance with the disclosed technology. As shown in fig. 6, the irrigation hub 100 may include a shunt 120 disposed at a distal end of the irrigation inlet chamber 112 and extending inwardly into the irrigation inlet chamber 112. In some examples, the shunt 120 may be a tapered member having an outer surface extending away from the longitudinal axis at an angle θ. The angle θ may be a predetermined angle sufficient to redirect fluid received from the irrigation supply tube 200 out of the plurality of irrigation openings 104 such that the fluid is directed generally transverse to the longitudinal axis 60. In some examples, the angle θ may direct fluid to the electrode 26. As non-limiting examples, the angle θ may be about 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, 60 °, 75 °, 85 °, or any other suitable angle for a particular application. Although described as a tapered member, the shunt may include other shapes having generally flat sides, generally curved sides, or other configurations in which fluid may be directed outwardly by the shunt 120 through the plurality of irrigation openings 104.
As will be appreciated, the irrigation opening 104 may extend outwardly from the irrigation inlet chamber 112 through the irrigation hub 100. As previously described, the rinse opening 104 may include an inlet region 105a that is smaller than an outlet region 105 b. The inlet region 105a may be adjacent to the flush inlet chamber 112, while the outlet region 105b may be disposed a distance from the flush inlet chamber 112. The surface 122 of the rinse opening 104 may extend between the inlet zone 105a and the outlet zone 105 b. The surface 122 may be configured such that the surface is disposed at an angle θ or substantially similar to the angle θ such that the fluid may be directed outwardly through the irrigation opening 104 without creating significant turbulence.
Fig. 6 also shows a sensor 608 attached to the sensor mount 108. As described above, the sensor may be a magnetic position sensor, a reference electrode, or any other sensor for a particular configuration. Although the sensor 608 is shown disposed about or through the sensor mount 108, the sensor 608 may also be disposed at a distal-most end of the sensor mount 108 (as shown in fig. 2, sensor 70), or the first sensor 70 may be disposed at a distal-most end of the sensor mount 108 and the second sensor 608 may be disposed about or through the sensor mount 108. The first sensor 70 and the second sensor 608 may be the same type of sensor or different types of sensors. In other examples, the sensor mount 108 may be configured to receive and support a plurality of sensors (e.g., a first sensor disposed about the sensor mount 108 and a second sensor disposed at a distal end of the sensor mount 108).
Fig. 7 illustrates a flow path 702 of fluid through the irrigation hub 100 according to an embodiment of the present utility model. As shown in fig. 7, the irrigation fluid may have a flow path 702 extending through the irrigation supply tube 200 and redirected outwardly by the irrigation hub 100. In some examples, the irrigation hub 100 may redirect fluid generally transverse to the longitudinal axis 60. In other examples, the irrigation hub 100 may redirect fluid at other angles as described herein to achieve a desired cooling effect at the electrode.
Fig. 8A and 8B illustrate another exemplary basket catheter 828 having a plurality of electrodes 826 disposed on a spine 822 and an irrigation hub 100 having a sensor 608 mounted thereon. As shown in fig. 8A, the electrodes 826 may be disposed on adjacent ridges 822 in alternating groupings of distal electrodes 826a and proximal electrodes 826 b. For example, and as shown in fig. 8A and 8B, two electrodes 826a, 826B may be disposed adjacent to each other on a spine 822 without additional electrodes 826 being disposed on the same spine 822. On a first ridge 822, two electrodes 826b may be disposed together near the proximal end of the ridge 822, while on a second adjacent ridge 822, two electrodes 826a may be disposed together near the distal end of the adjacent ridge 822. In this way, the electrodes 826a, 826b may be offset around the circumference of the basket catheter 828 so that the basket catheter 826 is better able to collapse when retracted into the sheath. When basket catheter 828 collapses, distal electrode 826a is fully positioned in the distal direction of proximal electrode 826b with a gap between proximal electrode 826b and distal electrode 826a along longitudinal axis 60.
With the configuration of the electrodes 826a, 826B disposed on the ridges 822 as shown in fig. 8A and 8B, the system 10 may be configured to output bipolar high voltage DC pulses, such as may be used to effect irreversible electroporation (IRE) between two adjacent electrodes 826a, 826B on a given ridge 822, electrically connect two adjacent electrodes 826 on a given ridge 822, and output bipolar high voltage DC pulses between one or more electrodes 822 on another ridge 822 of the basket catheter 828, and/or output monopolar high voltage DC pulses between one or more electrodes 828 and one or more electrode patches 38 disposed on the skin of the patient 23. The two electrodes 826 on a given ridge 822 may include an insulating material 827 disposed between the two electrodes 826a, 826b, thereby electrically isolating the two electrodes 826a, 826b from each other.
As shown in fig. 8A, the ridge 822 may be covered with an insulating sleeve 840 that may be disposed between the electrode 826 and the ridge 822. The insulating sleeve 840 may electrically isolate the electrode 826 from the ridge 822 to prevent arcing or shorting to the ridge 822. An insulating sleeve 840 may extend from the irrigation hub 100 to the distal end of the basket catheter 828. Further, insulating sleeve 840 may include a flared end 842 that may extend over at least a portion of central spine intersection 850. In this manner, the insulating sleeve 840 may have an atraumatic tip to prevent damage to tissue.
Fig. 8B is an illustration of basket catheter 828 with insulating sleeve 840, a pair of distal electrodes 826a and a pair of proximal electrodes 826B, and other ridge elements removed for illustration purposes so that the frame of basket catheter 828 is visible. As shown in fig. 8B, the ridges 822 may extend from the irrigation hub 100 and join together at a central ridge intersection 850. The central spine intersection 850 may include one or more cutouts 852 that allow the spine 822 to flex. The ridge 822 may also include electrode retention regions 860a, 860b configured to prevent the electrodes 826a, 826b from sliding proximally or distally along the ridge 822. As shown in fig. 8B, the first ridge 822 may have a distal ridge retention region 860a and an adjacent ridge may have a proximal ridge retention region 860B. In this way, the ridge retention regions 860a, 860b may alternate between a proximal position and a distal position along the ridge 822. That is, a first ridge 822 may have an electrode retention region 860b disposed near the proximal end of the ridge 822, and an adjacent ridge 822a may have an electrode retention region 860 disposed near the distal end of the ridge 822.
Each electrode-holding region 860 may include one or more cutouts 864 that may allow the ridges 822 to flex or contract inwardly. Each electrode retention region 860 may also include one or more retention members 862 that protrude outward and may be configured to prevent the electrode 826 from sliding proximally or distally along the ridge 822. During manufacture, the proximal end of the frame of basket catheter 828 is inserted into the lumen of electrodes 826a, 826b and electrodes 826a, 826b are slid distally along ridges 822 to their respective final positions. The cutouts 864 allow the electrodes 826a, 826b to slide over the retention members 862 a-c. Due to the one or more cutouts 864 in the ridges 822, the retention members 862a-c may be configured to move inward as the ridges 822 retract inward to allow the electrodes 826a, 826b to slide over the retention members 862 a-c. Once the electrodes 826a, 826b slide past the retention member 862, the retention member 862 can resiliently flex back to its previous position, thereby preventing the electrodes 826a, 826b from sliding proximally or distally along the ridge 822.
Proximal electrode retention area 860b includes proximal retention member 862c and distal retention member 862b. The proximal electrode retention region 860b need not be configured to allow the proximal electrode 826b to pass over the distal retention member 862b. Once the distal electrodes 826a are in their respective final positions, the distal electrode retention regions 860a utilize the central ridge intersection 850 to prevent distal movement of the distal electrodes 826 a.
While basket catheter 828 is shown with two electrodes 826 disposed proximate to each other on a given spine 822 and with alternating groupings of electrodes 826 on adjacent spines 822, the disclosed techniques may include other configurations of electrodes 826 and spines 822 that are not shown. For example, the disclosed techniques may include groupings of three or more electrodes 826 disposed on the ridge 822 and/or groupings of multiple electrodes 826. Accordingly, the disclosed techniques are not limited to the particular configuration of electrode 826 and ridge 822 shown and described herein.
The disclosed technology described herein may be further understood in light of the following clauses:
clause 1: an irrigation hub for an ablation catheter, the irrigation hub comprising: a cylindrical member extending along a longitudinal axis, the cylindrical member comprising: a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion; a distal end having a second outer diameter that is smaller than the first outer diameter; a flush inlet chamber disposed proximate the interior portion and configured to receive fluid from a flush supply; a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis; and a shunt extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
Clause 2: the irrigation hub of clause 1, wherein the plurality of irrigation openings are radially disposed about the cylindrical member and are configured to direct the fluid toward the electrode of the basket catheter.
Clause 3: the irrigation hub of clause 1 or 2, wherein each of the plurality of irrigation openings comprises an aperture having an outlet area greater than an inlet area.
Clause 4: the irrigation hub of any of clauses 1-3, wherein the shunt comprises a tapered member extending proximally into the irrigation inlet chamber along the longitudinal axis.
Clause 5: the irrigation hub of any of clauses 1-4, wherein at least a portion of each irrigation opening extends outwardly at an angle.
Clause 6: the irrigation hub of clause 5, wherein the angle of each irrigation opening relative to the longitudinal axis is approximately equal to the angle formed by the outer surface of the tapered member relative to the longitudinal axis.
Clause 7: the irrigation hub of any of clauses 1-6, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a catheter shaft.
Clause 8: the irrigation hub of any of clauses 1-6, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a force sensor.
Clause 9: the irrigation hub of clause 7 or 8, wherein the one or more attachment mechanisms comprise one or more bayonet mounts.
Clause 10: the irrigation hub of any of the preceding clauses, wherein the proximal end further comprises a plurality of relief lands radially disposed about an outer surface of the proximal end, each relief land of the plurality of relief lands configured to receive a ridge of a basket catheter.
Clause 11: the irrigation hub of any of the preceding clauses, wherein the distal end further comprises a sensor mount configured to receive and support a sensor.
Clause 12: the irrigation hub of clause 11, wherein the sensor comprises a reference electrode.
Clause 13: the irrigation hub of clause 11, wherein the sensor comprises a position sensor.
Clause 14: a medical probe, comprising: a tubular shaft extending along a longitudinal axis of the medical probe; a plurality of ridges configured to curve radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to a ridge of the plurality of ridges; and a flushing hub attached to the tubular shaft and configured to receive and support the plurality of ridges, the flushing hub including a cylindrical member extending along the longitudinal axis, the cylindrical member including: a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion; a distal end having a second outer diameter that is smaller than the first outer diameter; a flush inlet chamber disposed proximate the inner portion and configured to receive fluid from a flush supply line separate from the tubular shaft to prevent fluid from immersing in the tubular shaft; a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis; and a shunt extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
Clause 15: the medical probe of clause 14, wherein the plurality of ridges are configured to transition between an expanded state and a collapsed state.
Clause 16: the medical probe of clause 14 or 15, wherein the shunt is at least partially disposed in the irrigation inlet chamber.
Clause 17: the medical probe of any of clauses 14-16, wherein the plurality of irrigation openings are radially disposed about the cylindrical member and are configured to direct the fluid to the plurality of electrodes.
Clause 18: the medical probe of clause 17, each electrode of the plurality of electrodes having a tissue-facing surface and an inward-facing surface, the plurality of irrigation openings configured to direct the fluid toward the inward-facing surface of each electrode of the plurality of electrodes.
Clause 19: the medical probe of any of clauses 14-18, wherein each of the plurality of irrigation openings comprises an aperture having an exit area greater than an entrance area.
Clause 20: the medical probe of any of clauses 14-19, wherein the shunt includes a tapered member extending proximally into the irrigation inlet chamber along the longitudinal axis.
Clause 21: the medical probe of any of clauses 14-19, wherein at least a portion of each irrigation opening extends outwardly at an angle.
Clause 22: the medical probe of clause 21, wherein the angle of each irrigation opening relative to the longitudinal axis is approximately equal to the angle formed by the outer surface of the tapered member relative to the longitudinal axis.
Clause 23: the medical probe of any of clauses 14-22, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to the tubular shaft.
Clause 24: the medical probe of any of clauses 14-22, further comprising a force sensor disposed between the irrigation hub and the tubular shaft.
Clause 25: the medical probe of clause 24, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to the force sensor.
Clause 26: the medical probe of clause 23 or 25, wherein the one or more attachment mechanisms comprise one or more bayonet mounts.
Clause 27: the medical probe of any of clauses 14-26, wherein the proximal end further comprises a plurality of relief lands radially disposed about an outer surface of the proximal end, each relief land of the plurality of relief lands configured to receive a respective ridge of the plurality of ridges.
Clause 28: the medical probe of any of clauses 14-27, wherein the distal end further comprises a sensor mount configured to receive and support a sensor.
Clause 29: the medical probe of clause 28, wherein the sensor comprises a reference electrode.
Clause 30: the medical probe of clause 28, wherein the sensor comprises a position sensor.
Clause 31: a medical probe, comprising: a tubular shaft extending along a longitudinal axis of the medical probe; a plurality of ridges configured to curve radially outward from the longitudinal axis, each ridge of the plurality of ridges comprising a retaining member; a plurality of electrodes, each electrode of the plurality of electrodes attached to a spine of the plurality of spines and prevented by the retaining member from sliding proximally or distally along the spine, the plurality of electrodes disposed on the plurality of spines in groups disposed in alternating proximal and distal positions along adjacent spines; and an irrigation hub attached to the tubular shaft and configured to receive and support the plurality of ridges, the irrigation hub comprising a cylindrical member extending along the longitudinal axis and comprising: a plurality of irrigation openings disposed from a distal portion of an irrigation inlet chamber of the irrigation hub generally transverse to the longitudinal axis; and a diverter configured to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
The above embodiments are cited by way of example, and the present utility model is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present utility model includes both combinations and sub-combinations of the various features described 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.

Claims (20)

1. An irrigation hub for a medical probe, wherein the irrigation hub comprises:
a cylindrical member extending along a longitudinal axis, the cylindrical member comprising:
a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion;
a distal end having a second outer diameter that is smaller than the first outer diameter;
a flush inlet chamber disposed proximate the interior portion and configured to receive fluid from a flush supply;
a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis; and
a shunt extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
2. The irrigation hub of claim 1, wherein the plurality of irrigation openings are radially disposed about the cylindrical member and configured to direct the fluid toward an electrode of a basket catheter.
3. The irrigation hub of claim 1, wherein each irrigation opening of the plurality of irrigation openings comprises a hole having an outlet area greater than an inlet area.
4. The irrigation hub of claim 1, wherein the flow splitter comprises a tapered member extending proximally into the irrigation inlet chamber along the longitudinal axis.
5. The irrigation hub of claim 4, wherein at least a portion of each irrigation opening extends outwardly at an angle.
6. The irrigation hub of claim 5, wherein an angle of each irrigation opening relative to the longitudinal axis is equal to an angle formed by an outer surface of the tapered member relative to the longitudinal axis.
7. The irrigation hub of claim 1, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a catheter shaft.
8. The irrigation hub of claim 1, wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a force sensor.
9. The irrigation hub of claim 8, wherein the one or more attachment mechanisms comprise one or more bayonet mounts.
10. The irrigation hub of claim 1, wherein the proximal end further comprises a plurality of relief lands disposed radially about an outer surface of the proximal end, each relief land of the plurality of relief lands configured to receive a ridge of a basket catheter.
11. The irrigation hub of claim 1, wherein the distal end further comprises a sensor mount configured to receive and support a sensor.
12. The irrigation hub of claim 11, wherein the sensor comprises a reference electrode.
13. The irrigation hub of claim 11, wherein the sensor comprises a position sensor.
14. A medical probe, wherein the medical probe comprises:
a tubular shaft extending along a longitudinal axis of the medical probe;
A plurality of ridges configured to curve radially outward from the longitudinal axis;
a plurality of electrodes, each electrode of the plurality of electrodes attached to a ridge of the plurality of ridges; and
an irrigation hub attached to the tubular shaft and configured to receive and support the plurality of ridges, the irrigation hub comprising a cylindrical member extending along the longitudinal axis and comprising:
a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion;
a distal end having a second outer diameter that is smaller than the first outer diameter;
a flush inlet chamber disposed proximate the inner portion and configured to receive fluid from a flush supply line separate from the tubular shaft to prevent fluid from immersing in the tubular shaft;
a plurality of irrigation openings disposed from a distal portion of the irrigation inlet chamber generally transverse to the longitudinal axis; and
a shunt extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
15. The medical probe of claim 14, wherein the plurality of ridges are configured to transition between an expanded state and a collapsed state.
16. The medical probe of claim 14, wherein the plurality of irrigation openings are radially disposed about the cylindrical member and configured to direct the fluid toward the plurality of electrodes.
17. The medical probe of claim 14, wherein each electrode of the plurality of electrodes has a tissue-facing surface and an inward-facing surface, the plurality of irrigation openings configured to direct the fluid toward the inward-facing surface of each electrode of the plurality of electrodes.
18. The medical probe of claim 14, wherein the medical probe further comprises a force sensor disposed between the irrigation hub and the tubular shaft.
19. The medical probe of claim 18, wherein the proximal end includes one or more attachment mechanisms configured to releasably attach the proximal end to the force sensor.
20. A medical probe, wherein the medical probe comprises:
a tubular shaft extending along a longitudinal axis of the medical probe;
A plurality of ridges configured to curve radially outward from the longitudinal axis, each ridge of the plurality of ridges comprising a retaining member;
a plurality of electrodes, each electrode of the plurality of electrodes attached to a spine of the plurality of spines and prevented by the retaining member from sliding proximally or distally along the spine, the plurality of electrodes disposed on the plurality of spines in groups disposed in alternating proximal and distal positions along adjacent spines; and
an irrigation hub attached to the tubular shaft and configured to receive and support the plurality of ridges, the irrigation hub comprising a cylindrical member extending along the longitudinal axis and comprising:
a plurality of irrigation openings disposed from a distal portion of an irrigation inlet chamber of the irrigation hub generally transverse to the longitudinal axis; and
a diverter configured to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse to the longitudinal axis.
CN202321007929.8U 2022-04-28 2023-04-28 Irrigation hub for medical probe and medical probe Active CN220655661U (en)

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US63/336094 2022-04-28
US63/336023 2022-04-28
US63/477819 2022-12-29
US18/192361 2023-03-29
US18/192,361 US20230346465A1 (en) 2022-04-28 2023-03-29 Irrigation hub for an ablation catheter

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