Medical device with end effector including connecting hub and electrode array
By designing a medical device end effector that can move between an expanded and collapsed configuration, the problem of difficulty in maintaining the ridge position and large-size basket catheter operation challenges in the prior art is solved, achieving higher operating stability and accuracy of IRE ablation.
Patent Information
- Application Number
- CN202411313095.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-22
- Filing Date
- 2024-09-20
- Publication Date
- 2025-03-25
AI Technical Summary
Prior art When cardiac tissue ablation is performed using irreversible electroporation (IRE), it is difficult to effectively maintain the distal/proximal portion of the ridge and is challenging to operate in large-sized basket catheters.
An end effector for a medical device is designed, the actuator comprising a plurality of ridges extending along a longitudinal axis, the ridges being movable between the expansion and collapsed configurations, and equipped with a connecting hub and an actuator member to prevent relative movement between the connecting hub and the ridge, and to achieve configuration transformation of the ridges by the actuator member.
Through the design of the end effector, the position of the ridge can be effectively maintained, the operation stability and flexibility in large-size basket catheters are improved, and the accuracy and safety of IRE ablation are enhanced.
Smart Images

Figure CN119679501A_ABST
Abstract
Description
Technical Field
[0001] The present technology relates generally to medical devices, and particularly to medical probes having electrodes, and further, but not exclusively, to medical probes suitable for inducing irreversible electroporation (IRE) of cardiac tissue. Background Art
[0002] Arrhythmias, such as atrial fibrillation (AF), occur when an area of cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal causing the arrhythmia and disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue through the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.
[0003] Many current ablation methods in the art utilize radiofrequency (RF) electrical energy to heat tissue.RF ablation can have certain risks associated with thermal heating that can result in tissue charring, burning, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.
[0004] Cryoablation is an alternative to RF ablation that generally reduces the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.
[0005] Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue and generates irreversible cell membrane permeabilization. It has been previously proposed in the patent literature to use a multi-electrode probe to deliver IRE energy to tissue. 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.
[0006] Basket end effectors include spines that must be held in place at their distal portions to function properly. Improved techniques are needed to hold the distal / proximal portions of the spines. There is also a need for larger size basket catheters for pulmonary vein isolation (PVI) using IRE. Summary of the invention
[0007] According to the disclosed technology, an end effector for a medical device is provided. The end effector may include a plurality of ridges extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration. Each ridge includes a proximal end and a distal end. The end effector may include a plurality of electrodes connected to each ridge. The end effector may include a connecting hub defining a hub lumen and including a first terminal, a second terminal, and a plurality of grooves. The plurality of grooves are radially arranged around the outer circumferential surface of the connecting hub and extend parallel to the longitudinal axis. Each groove opens at or near the first terminal along the longitudinal axis. Each groove cooperates with one of the proximal end and the distal end of a corresponding ridge in the plurality of ridges to prevent relative movement between the connecting hub and the ridge. The end effector may also include an actuator member connected to the connecting hub and the plurality of ridges, so that translation of the actuator member along the longitudinal axis moves the ridge from an expanded configuration to a collapsed configuration.
[0008] According to the disclosed technology, a connection hub for an end effector of a medical device is further provided. The connection hub may include a first terminal, a second terminal opposite to the first terminal, a cylindrical body, and a plurality of grooves. The cylindrical body defines a hub lumen and extends from the first terminal to the second terminal along a longitudinal axis. A plurality of grooves are radially arranged around the outer circumferential surface of the cylindrical body and extend parallel to the longitudinal axis. Each groove opens at or proximal to the first terminal along the longitudinal axis, and each groove is configured to cooperate with a proximal end or a distal end of a ridge of the end effector. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 is a schematic illustration of a medical system including a medical device according to the disclosed technology, the distal end of the medical system including a medical probe having electrodes;
[0010] Figure 2 is a schematic illustration showing a perspective view of an end effector of a medical device according to the disclosed technology;
[0011] Figure 3 is a schematic illustration showing a detailed perspective view of a distal end of an end effector according to the disclosed technology, with coils and loops removed for clarity;
[0012] Figure 4 is a diagram showing how the disclosed technology Figure 3 a schematic illustration of a detailed cross-sectional view of the distal end shown, the distal end being cut relative to a vertical plane intersecting the longitudinal axis;
[0013] Figure 5is a schematic illustration showing a detailed perspective view of a proximal end of an end effector according to the disclosed technology, with the cannula removed for clarity;
[0014] Figure 6 is a diagram showing how the disclosed technology Figure 5 a schematic illustration of a detailed cross-sectional view of the proximal end portion shown, the proximal end portion being cut relative to a vertical plane intersecting the longitudinal axis;
[0015] Figure 7 It is a diagram showing the disclosed technology Figure 3 a schematic illustration of an enlarged detailed perspective view of the proximal end shown with tubing removed for clarity;
[0016] Figure 8 is a schematic illustration showing a perspective view of a second end effector according to the disclosed technology;
[0017] Fig. 9 It is a diagram showing the disclosed technology Fig. 9 a schematic illustration of a detailed cross-sectional view of the second end effector shown, the second end effector being cut relative to a vertical plane intersecting the longitudinal axis, wherein an exterior region of the second end effector is not shown;
[0018] Fig.10 is a schematic illustration showing a perspective view of a third end effector according to the disclosed technology;
[0019] Fig.11 is a diagram showing a method similar to that disclosed in accordance with the disclosed technology. Fig.10 a schematic illustration of a perspective view of a third end effector of with the elongated shaft, ring, and coil removed for clarity;
[0020] Fig.12 It is a diagram showing the disclosed technology Fig.11 a schematic illustration of a detailed cross-sectional view of a third end effector shown cut relative to a vertical plane intersecting the longitudinal axis;
[0021] Fig.13 is a schematic illustration showing a detailed perspective view of a proximal end of a third end effector according to the disclosed technology, with a sleeve and some ridges removed for clarity;
[0022] Fig.14 is a schematic illustration showing a detailed exploded view of a proximal hub of a third end effector according to the disclosed technology;
[0023] Fig.15 is a schematic illustration showing a detailed perspective view of a proximal hub of a third end effector according to the disclosed technology;
[0024] Fig.16 is a schematic illustration showing a detailed front view of a proximal hub of a third end effector according to the disclosed technology; and
[0025] Fig.17 is a schematic illustration showing a detailed perspective view of yet another connection hub in accordance with the disclosed technology. DETAILED DESCRIPTION
[0026] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements in different drawings are labeled the same. The accompanying drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of the present disclosure. The detailed description illustrates the principles of the disclosed technology by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the disclosed technology, and describes several embodiments, adaptations, variations, alternative forms and uses of the disclosed technology, including what is currently believed to be the best way to implement the disclosed technology.
[0027] 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 purpose it is intended to achieve as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject technology in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.
[0028] As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal can be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject can be, for example, any suitable human patient.
[0029] As discussed herein, an "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.
[0030] 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 irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.
[0031] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation protocols describe ablation protocols that differ in current paths and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, wherein one electrode having a high current density and a high electric flux density is positioned at the treatment site, and a second electrode having a relatively lower current density and a lower electric flux density is positioned away from the treatment site.
[0032] As discussed herein, the terms "tubular," "tube," and "shaft" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross section or a uniform cross section throughout their length. For example, tubular / shaft structures are generally illustrated as structures that are substantially perfect cylinders. However, tubular / shaft structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.
[0033] The present disclosure relates to systems, methods or uses and devices for performing IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.
[0034] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.
[0035] The present disclosure may include electrodes configured for irreversible electroporation (IRE), RF ablation, and / or cryoablation. Throughout the present disclosure, IRE may be referred to interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.
[0036] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to the loss of homeostasis and usually dies by apoptosis. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.
[0037] The technology disclosed herein includes systems and methods for applying electrical signals from catheter electrodes positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the system and method can effectively ablate targeted tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrode is lower than the electric field threshold of the target tissue that allows cell repair. Reversible electroporation does not kill cells, but allows physicians to view the effects of reversible electroporation on electrical activation signals near the target location. Example systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire contents of which are incorporated herein by reference.
[0038] The effectiveness of pulsed electric field and its induction of reversible electroporation and / or irreversible electroporation may be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples proposed herein generally include physical parameters suitable for effectively inducing reversible electroporation and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse phase delay, pulse delay, total application time, energy delivered, etc. In some examples, the parameters of the electrical signal may be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire contents of each of which are incorporated herein by reference.
[0039] refer to Figure 1, which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An example medical device / probe, such as a catheter 14, configured for sensing IEGM is illustrated herein. The physician 24 brings the distal end of the catheter 14 (i.e., in this case, the basket assembly 28) into contact with the heart wall for sensing a target site in the heart 12. The catheter 14 with a distal basket assembly may be referred to as a basket catheter. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.
[0040] The catheter 14 is an exemplary catheter that includes one and preferably a plurality of electrodes 26, optionally distributed on a plurality of spines 104 at a basket assembly 28 and configured to sense IEGM signals. The catheter 14 may additionally include a position sensor embedded in or near the basket assembly 28 for tracking the position and orientation of the basket assembly 28. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.
[0041] The magnetic-based position sensor can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the basket assembly 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. The details of the magnetic-based position sensing technology are described in U.S. Patents 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.
[0042] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 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 position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.
[0043] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.
[0044] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the 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.
[0045] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.
[0046] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple 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 on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTOTM 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.
[0047] Figure 2 is a schematic illustration of a perspective view of an end effector of a medical device 14 (such as a medical probe) having an electrode 26. The medical device 14 includes an end effector 100 at its distal end 28. The end effector 100 in the example currently described takes the form of a basket assembly including at least one ridge 104. The ridge 104 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as nitinol) forming a strut. The ridge 104 may be formed from a planar or cylindrical tubular stock material using any suitable method. For example, the ridge 104 may be formed by cutting, laser cutting, stamping, etc. The ridge 104 has a distal end 104A ( Figure 4 ) and the proximal end 104B ( Figure 6 ) and extends along the longitudinal axis A1. The ridge 104 is movable between an expanded configuration and a collapsed configuration via an actuator member. The actuator member is connected / coupled to the ridge such that translation of the actuator member along the longitudinal axis moves the ridge from the expanded position to the collapsed position.
[0048] In the examples described herein, electrodes 26 may be configured to deliver ablative energy (IRE and / or RF) to tissue in heart 12. Figure 2 , each ridge 104 has a midpoint (e.g., the ridge 104 extends from away from the longitudinal axis A1 to an approximate point where it bends toward it), and there are four electrodes 26 connected to each ridge. The first two of the four electrodes 26 are disposed on a first side of the midpoint of each ridge 104, and the last two of the four electrodes 26 are disposed on a second side of the midpoint of each ridge 104. In addition to using the electrodes 26 to deliver ablation energy, the electrodes 26 can also be used to determine the position of the end effector 100 and / or measure physiological properties, such as local surface potentials at corresponding locations on tissue in the heart 12. The electrodes 26 can be biased so that a larger portion of the electrodes 26 faces outward from the end effector 100, so that the electrodes 26 deliver a larger amount of electrical energy outward away from the end effector 100 (i.e., toward the heart 12 tissue) rather than inward toward the end effector 100.
[0049] Examples of materials ideally suited for forming electrode 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablative energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode on the inside of the ridge), and then to the blood pool in the heart 12.
[0050] The end effector 100 is connected to the rest of the medical probe 14 via an elongated shaft 102. The elongated shaft 102 connects the end effector 100 to a handle, which the operator 24 can manipulate in use. The elongated shaft 102 can be tubular in form and flexible, with certain portions being more flexible than other portions. For example, its end portion can be made more flexible than the rest to allow for easy deflection of the end effector 100. The elongated shaft 102 can be formed of a flexible, biocompatible, electrically insulating material, such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and the like. In some examples, the insulating material may include a biocompatible polymer, including but not limited to: polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response. In addition, the flexible sleeve 120 is disposed above the proximal end of the end effector 100 to further enhance the non-invasiveness of the end effector 100.
[0051] Connector tube or rod 118 is connected to the distal end 104A of the spine. In some examples, connector tube 118 is used as an actuator member to facilitate expansion and collapse of spine 104. For example, as discussed above, connector tube 118 can translate along longitudinal axis A1 to expand / collapse spine 104. In the expanded configuration (e.g., Figure 2 ) and collapsed configurations, one or more ridges 104 may bend radially outward from the longitudinal axis A1. Alternatively, another actuator member (e.g., a pull wire) may be used in conjunction with the connector tube 118, wherein the connector tube / rod 118 is used for other purposes, such as for routing irrigation. For example, the connector tube 118 may include multiple irrigation holes along its length or provide a channel for other irrigation tubes. The connector tube may also include a reference electrode or a return electrode connected thereto. When the elongated shaft 200 is straightened, the ridges 104, the elongated shaft 102, and the connector tube 118 are arranged generally along the longitudinal axis A1 (i.e., parallel to or coaxial with the longitudinal axis). The connector tube 118 also defines an inner cavity 118A ( Figure 3), the inner cavity is coaxial with the longitudinal axis A1, and when in use, various medical devices (such as a mapping catheter or a guidewire) can extend through the inner cavity.
[0052] The non-invasive ring 114 and the coil 116 are connected to the distal end 104A of the spine 104. In some examples, the coil 116 may include a single axis sensor (SAS). In other examples, the coil 116 may include a dual axis sensor (DAS) or a three axis sensor (TAS). The coil 116 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The coil 116 may include an electrical lead for conducting the current induced on the coil to the patient interface unit 30. As will be known, by attaching the coil 116 to the distal end of the end effector 100, the position of the distal end can be detected. In this way, the physician 24 can more accurately determine the position of the distal end of the end effector 100 before applying ablation energy to the tissue.
[0053] An insulating material (referred to herein as a sheath 106) is disposed over each ridge 104. Each sheath 106 is used to enhance the non-invasiveness of the end effector 100, to protect the subject from sharp edges, and for flushing purposes as described in more detail below. The sheath 106 may comprise a polymer. For example, the sheath 106 may be formed of a flexible, biocompatible, electrically insulating material such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and the like. In some examples, the insulating material may include a biocompatible polymer, including, but not limited to, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response. Furthermore, while the sheath 106 is shown in these figures as being tubular, the sheath 106 may be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the sheath 106 produces the physical and / or mechanical properties required of the end effector 100 as mentioned above, such as rigidity and flexure along multiple axes.
[0054] Figure 3 is a schematic illustration showing a detailed perspective view of the distal end of end effector 100 with coil 116 and loop 114 removed for clarity. Figure 4 It is shown as Figure 3 Shown is a schematic illustration of a detailed cross-sectional view of the distal end portion, which is cut relative to a vertical plane intersecting the longitudinal axis A1.
[0055] refer to Figure 3 and Figure 4 , the ridges 104 are connected at their distal ends 104A to a distal hub 108, also referred to herein as a connecting hub. The distal hub 108 is a unitary cylindrical body defining a distal hub lumen 108 that is connected to a connector tube 118. The distal hub 108 may be made of nitinol or any other suitable biocompatible material. The distal hub 108 extends from a first terminal (i.e., relative to the distal end) of the connector tube 118. Figure 3 , the leftmost end of the distal hub 108 along the longitudinal axis A1) extends to a second terminal opposite to the first terminal (ie, relative to Figure 3 , the rightmost end of the distal hub 108 along the longitudinal axis A1).
[0056] In addition, the distal hub 108 defines a plurality of inverted T-shaped grooves 110A that are radially symmetrical, disposed around and defined in the outer circumferential surface of the distal hub 108, and extend parallel to the longitudinal axis A1. Figure 4 As seen in the cross-sectional view of , each groove 110A is open at a first terminal end and a second terminal end along the longitudinal axis A1 (i.e., there is no material at these ends to define the termination points of these grooves 110A). In other words, each groove 110A extends the entire length of the distal hub 108. In addition, each groove 110A receives and cooperates with the distal end 104A of the corresponding ridge 104 to prevent relative movement between the distal hub 108 and the ridge 104. The distal ends 104A cooperate with the distal hub 108 by sliding them into the groove 110A in a direction parallel to the longitudinal axis A1.
[0057] Continue to refer Figure 3 and Figure 4 , T-shaped formations 110 are defined between adjacent grooves 110A having an inverted T shape. The grooves 110A space the T-shaped formations 110 from each other. The upper portions of adjacent T-shaped formations 110 engage the outer surface of each corresponding ridge 104 to prevent relative movement therebetween.
[0058] Figure 5 is a schematic illustration showing a detailed perspective view of the proximal end of end effector 100 with cannula 120 removed for clarity. Figure 6 It is shown as Figure 5 Shown is a schematic illustration of a detailed cross-sectional view of the proximal end portion, which is cut relative to a vertical plane intersecting the longitudinal axis A1. Figure 7 It is a diagram showing the disclosed technology Figure 3 A schematic illustration of an enlarged detailed perspective view of the proximal end is shown with tubing 136 removed for clarity (tubing 136 is discussed in more detail below).
[0059] Main references Figures 5 to 7 , the ridges 104 are connected at their proximal ends 104B to a proximal hub 122, also referred to herein as a connecting hub. The proximal hub 122 is a unitary cylindrical body defining a proximal hub lumen 126 that is indirectly connected to the connector tube 118. The proximal hub 122 may be made of nitinol or any other suitable biocompatible material. The proximal hub 122 extends from the first terminal (i.e., relative to the Figure 6 , the leftmost end of the proximal hub 122 along the longitudinal axis A1) extends to a second terminal opposite to the first terminal (ie, relative to Figure 6 , the rightmost end of the proximal hub 122 along the longitudinal axis A1).
[0060] In addition, similar to the distal end, the proximal hub 122 defines a plurality of inverted T-shaped grooves 124A that are radially symmetrical, disposed around and defined in the outer circumferential surface of the proximal hub 122, and extend parallel to the longitudinal axis A1. Figure 6 As can be seen from the cross-sectional view of FIG. 1 , each groove 124A (due to the proximal end 104B being disposed in the groove 124A) Figure 6 Not clearly marked, reference Figure 7 ) are open at first and second terminal ends along the longitudinal axis A1 (i.e., there is no material at these ends to define the termination points of these grooves 124A). In other words, each groove 124A extends the entire length of the proximal hub 122. In addition, each groove 124A receives the proximal end 104A of the corresponding ridge 104 and cooperates with it to prevent relative movement between the proximal hub 122 and the ridge 104. The proximal ends 104B cooperate with the proximal hub 122 by sliding them into the grooves 124A in a direction parallel to the longitudinal axis A1. They are held in place by any suitable means, such as friction fit, fasteners, adhesives, etc.
[0061] Continue to refer Figure 5 and Figure 6 , T-shaped formations 124 are defined between adjacent grooves 124A having an inverted T shape. The grooves 124A space the T-shaped formations 124 from each other. The upper portions of adjacent T-shaped formations 124 engage the outer surface of each corresponding ridge 104 to prevent relative movement therebetween.
[0062] In some examples, the proximal hub 122 and the distal hub 108 are designed identically to increase modularity of the connection hubs. Figure 7 As specifically shown in FIG. 1 , the opposite upper sides of each T-shaped formation 124 define respective grooves 124B. Adjacent grooves 124B of adjacent T-shaped formations 124 form a groove pair. Figure 7 As best seen in FIG. 1 , each groove pair is disposed above a corresponding recess 124A that separates corresponding adjacent T-shaped formations 124. In other words, the groove pairs and recesses 124A are substantially radially aligned with each other.
[0063] Additionally, at the proximal end of the end effector 100 is a proximal tubular housing 128 that mates with the proximal hub 122 along the longitudinal axis A1. The tubular housing 128 defines a housing lumen 130 through which the connector tube 118 extends. The proximal hub 122 slides over the distal portion of the tubular housing 128 so that the tubular housing 128 extends through the hub lumen 126 of the proximal hub 122. Figure 7 As seen in FIG. 1 , the outer surface of the distal portion of the tubular housing 128 is a housing groove 128A that is aligned with the hub groove 124B along the longitudinal axis A1. Figure 5 and Figure 7 Each hub groove pair 124B and aligned housing groove 128A cooperatively receives an electrical conduit 136 through which electrical wires / connectors may be routed to electrically connect the end effector 100 to the rest of the system.
[0064] Figure 8 is a schematic illustration showing a perspective view of the second end effector 200 . Fig. 9 It is shown Figure 3 Schematic illustration of a detailed cross-sectional view of a second end effector 200 shown, the second end effector being cut relative to a vertical plane intersecting the longitudinal axis A1. The specific details of the second end effector 200 in contrast to the first end effector 100 are concentrated in the following description. It should be understood that many of the features discussed with respect to the first end effector 100 can be appropriately incorporated into the second end effector 200, and vice versa. For example, the second end effector 200 can have a similar or identically designed elongated shaft 202, a ridge 204 having a distal end 204A and a proximal end 204B, a distal hub 208, a distal hub lumen 212, a ring 214, a coil 216, a proximal sleeve 220, a proximal hub 222, and a proximal tubular housing 228.
[0065] exist Figure 8 , each ridge 204 has three electrodes 26 positioned thereon such that each three electrodes 26 on each respective ridge are aligned with one another from ridge 204 to ridge 204. In other words, each ridge 204 has electrodes 26 positioned at the same location along their length. With three electrodes 26 on a ridge, the electrodes 26 have a total tissue contact surface area sufficient to safely deliver a PFA pulse of approximately 2000V.
[0066] In addition to the above, the second end effector 200 is mainly different in the actuator member 218, which actuates the spine between the collapsed configuration and the expanded configuration and / or provides irrigation around the end effector 200. The actuator member 218 shows a pull wire 218A and includes an irrigation tube 218B. The irrigation tube 218B extends along the longitudinal axis A1. The irrigation tube 218B also includes a hole 218C for permitting the distribution of an irrigation fluid (such as saline) around each electrode 26. The pull wire 218A extends through the irrigation tube 218B and is connected to the spine 104 so that it can move the spine 104 between the expanded configuration and the collapsed configuration. More specifically, a distal hub fastener 208A (to which the puller wire 218A is attached) is connected to the distal hub 208 within the distal hub lumen 212, which, as discussed above with respect to the end effector 100, mates with the distal end 204A of the spine 204. At the proximal side of the end effector 200, within the proximal tubular housing 228, are one or more O-rings 228. The O-rings are configured to maintain the radial positioning of the puller wire 218A relative to the longitudinal axis A1, and permit stable anterior-posterior translation of the puller wire 218A to actuate the spine 204.
[0067] Fig.10 is a schematic illustration showing a perspective view of the third end effector 300 . Fig.11 is shown similar to Fig.10 314 is a schematic illustration of a perspective view of a third end effector 300 with the elongated shaft 302, ring 314, and coil 316 removed for clarity. Fig.12 It is shown Fig.11 A schematic illustration of a detailed cross-sectional view of a third end effector 200 is shown, the third end effector being cut relative to a vertical plane intersecting the longitudinal axis A1. Specific details of the third end effector 300 in contrast to the first end effector 100 and the second end effector 200 are concentrated in the following description. It should be understood that many of the features discussed with respect to the previously discussed end effectors 100, 200 may be appropriately incorporated into the third end effector 300, and vice versa. For example, the third end effector 300 may have an elongated shaft 302 of similar or identical design, a ridge 304 having a distal end 304A and a proximal end 304B, a distal hub 308, a distal hub lumen 312, a ring 314, a coil 316, and a proximal sleeve 320. Reference Fig.12 , the actuator member 318 of the third end effector 300 includes an actuator rod 318 and an irrigation tube 318, which, although differently constructed, function in a similar manner to that discussed above.
[0068] Fig.13is a schematic illustration showing a detailed perspective view of the proximal end of the third end effector 300 with the sleeve 320 and some of the ridges 304 removed for clarity. Fig.14 is a schematic illustration showing a detailed exploded view of the proximal hub 322 of the third end effector 300 . Fig.15 is a schematic illustration showing a detailed perspective view of the proximal hub 322 of the third end effector 300 . Fig.16 is a schematic illustration showing a detailed front view of the proximal hub 322 of the third end effector 300 .
[0069] Reference now Figures 13 to 16 , a proximal hub 322 (also referred to herein as a connecting hub) is formed of multiple parts to which the proximal end 304B of the ridge 304 is connected. The proximal hub 322 can be made of nitinol or any other suitable biocompatible material. Similar to the other described hubs, the proximal hub 322 includes a cylindrical body 322A that defines a proximal hub lumen 326 that is directly or indirectly connected to the irrigation tube 318B. The cylindrical body 322A extends from a first terminal (i.e., relative to the proximal end 304B of the ridge 304). Fig.11 , the leftmost end of the proximal hub 322 along the longitudinal axis A1) extends to a second terminal opposite to the first terminal (ie, relative to Fig.11 , the rightmost end of the proximal hub 322 along the longitudinal axis A1). The cylindrical body 322A has fins 322B radially arranged around the cylindrical body so that they protrude from the outer circumferential surface of the cylindrical body 322A. Receiving channels 322C are defined between adjacent fins 322B, which function in a manner discussed in more detail below.
[0070] Similar to the previously described examples, a plurality of grooves 324A are also provided which are radially arranged around the outer circumferential surface of the cylindrical body 322A and extend parallel to the longitudinal axis A1. However, in this example, the grooves 324A are formed in a ridge coupler 324 which is partially cuboid in form and has arcuate upper and lower surfaces and tapered side surfaces (see Fig.16 On its proximal side, the ridge coupler 324 includes a stopper 324B that projects toward the longitudinal axis and that, when engaged with the cylindrical body 322A ( Fig.15 ) when engaging the first terminal end of the cylindrical body (e.g., the ridge connector 324 can be formed by Fig.14 324B slides onto the cylindrical body 322A in the direction indicated by the arrow in FIG. 324B). Thus, the ridge coupler 324 is partially offset from the cylindrical body 322A along the longitudinal axis A1 such that the stopper 324B overhangs the cylindrical body 322A.
[0071] The stopper 324B maintains the ridge coupler 324 in position relative to the cylindrical body 322A and prevents the ridge 304 from pulling the coupler 324 beyond the cylindrical body 322A. In other words, the stopper 324B prevents longitudinal translation of the ridge coupler 324 relative to the cylindrical body 322A in at least one direction. Fig.15 and Fig.16 As can be seen in particular, the ridge coupler 322C is located within the receiving channel 322C and is laterally constrained by the fins 322B.
[0072] Furthermore, the groove 324A formed in the upper surface of the ridge coupler 324 is shaped to match the shape of the proximal end 304B of the ridge 304 ( Fig.13 ) are aligned. Thus, to mate the groove 324A and the proximal end 304B, each proximal end 304B slides into the corresponding groove 324A in a direction perpendicular to the longitudinal axis A1. Due to the offset between the ridge coupler 324 and the cylindrical body 322A, the groove 324A has an open end that terminates proximal to (but not flush with) the second terminal end of the cylindrical body 322A (see, for example, Fig.15 ). If you can also Fig.15 As seen in FIG. 3 , the end of groove 324A opposite the open end is closed because that end conforms to the shape of the distal end of ridge 304 that it receives.
[0073] Fig.17 is a schematic illustration showing a detailed perspective view of yet another connecting hub 422. This connecting hub is similar in structure to the aforementioned proximal hub 322, but is formed as a unitary hub rather than as a separate component.
[0074] The disclosed technology described herein can be further understood according to the following terms:
[0075] Item 1. An end actuator for a medical device, the end actuator comprising: a plurality of ridges extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration, each ridge comprising a proximal end and a distal end; a plurality of electrodes connected to each ridge; a connecting hub defining a hub lumen and comprising a first terminal, a second terminal and a plurality of grooves, the plurality of grooves being radially arranged around an outer circumferential surface of the connecting hub and extending parallel to the longitudinal axis, each groove opening along the longitudinal axis at or proximal to the first terminal, each groove cooperating with one of the proximal end and the distal end of a corresponding ridge among the plurality of ridges to prevent relative movement between the connecting hub and the ridges; and an actuator member connected to the connecting hub and the plurality of ridges such that translation of the actuator member along the longitudinal axis moves the ridges from the expanded configuration to the collapsed configuration.
[0076] Clause 2. According to the end actuator described in Clause 1, when the corresponding groove receives the one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the corresponding groove in a direction parallel to the longitudinal axis.
[0077] Clause 3. According to the end actuator described in Clause 1, when the corresponding groove receives the one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the corresponding groove in a direction perpendicular to the longitudinal axis.
[0078] Clause 4. An end actuator according to any one of clauses 1 to 3, further comprising a connector tube extending parallel to the longitudinal axis and extending through the hub lumen from the proximal end of the plurality of ridges to the distal end of the plurality of ridges, the connector tube defining a connector tube lumen.
[0079] Clause 5. The end effector of Clause 4, wherein the connector tube defines a plurality of flushing apertures.
[0080] Clause 6. The end actuator according to Clause 1, further comprising: an irrigation tube extending along the longitudinal axis, the actuator assembly comprising a pull wire extending through the irrigation tube and connected to the distal ends of the plurality of ridges, the pull wire being configured to move the plurality of ridges between the expanded configuration and the collapsed configuration.
[0081] Clause 7. An end actuator according to clause 1, further comprising: an irrigation tube extending along the longitudinal axis, the actuator assembly comprising an actuator rod extending through the irrigation tube and connected to the distal ends of the plurality of ridges, the actuator rod being configured to move the plurality of ridges between the expanded configuration and the collapsed configuration.
[0082] Clause 8. The end effector of clause 7, wherein the actuator rod comprises a reference electrode or a return electrode.
[0083] Clause 9. The end effector according to any one of clauses 7 to 8, wherein the actuator rod defines an actuator rod lumen configured for a guide wire or a mapping catheter to pass through the actuator rod lumen.
[0084] Clause 10. The end effector of any one of Clauses 6 to 9, the irrigation tube comprising holes for permitting saline to be distributed around each of the plurality of electrodes.
[0085] Clause 11. The end effector of any one of Clauses 1 to 10, further comprising a proximal tubular housing that mates with the connecting hub along the longitudinal axis.
[0086] Clause 12. The end effector of Clause 11, wherein the proximal tubular housing extends through the hub lumen.
[0087] Clause 13. The end effector of any one of clauses 11 to 12, wherein the connecting hub defines a plurality of hub grooves, and the proximal tubular housing comprises a plurality of housing grooves aligned with the plurality of hub grooves along the longitudinal axis.
[0088] Clause 14. The end effector of clause 13, further comprising a plurality of electrical conduits, each of the plurality of electrical conduits being received in the aligned plurality of housing grooves and the plurality of hub grooves, respectively.
[0089] Clause 15. An end actuator according to any one of clauses 1 to 14, wherein the plurality of electrodes include three electrodes connected to each ridge, each three electrodes on the corresponding ridges are laterally aligned with each other, and the plurality of electrodes have a total tissue contact surface area sufficient to deliver a 2000V pulsed field ablation (PFA) pulse.
[0090] Clause 16. An end actuator according to any one of clauses 1 to 14, wherein each ridge has a midpoint, and the plurality of electrodes include four electrodes connected to each ridge, wherein the first two electrodes of the four electrodes are on a first side of the midpoint of each ridge, and the last two electrodes of the four electrodes are on a second side of the midpoint of each ridge.
[0091] Clause 17. The end effector of any one of Clauses 1 to 16, further comprising a magnetic positioning sensor connected to the distal end of the plurality of ridges.
[0092] Item 18. A connecting hub for an end actuator of a medical device, the connecting hub comprising: a first terminal; a second terminal, the second terminal being opposite to the first terminal; a cylindrical body, the cylindrical body defining a hub inner cavity and extending from the first terminal to the second terminal along a longitudinal axis; and a plurality of grooves, the plurality of grooves being radially arranged around an outer circumferential surface of the cylindrical body and extending parallel to the longitudinal axis, each groove opening at the first terminal or proximal to the first terminal along the longitudinal axis, and each groove being configured to cooperate with a proximal end or a distal end of a ridge of the end actuator.
[0093] Clause 19. The connection hub of Clause 18, each groove being defined in the outer circumferential surface of the cylindrical body.
[0094] Clause 20. The connection hub of any one of clauses 18 to 19, each groove extending the entire length of the cylindrical body.
[0095] Clause 21. The connecting hub of any one of clauses 18 to 20, wherein adjacent grooves define T-shaped formations therebetween, and each groove separates adjacent T-shaped formations.
[0096] Clause 22. The connection hub of Clause 21, wherein opposing upper sides of each T-shaped formation each define a groove, wherein adjacent grooves of adjacent T-shaped formations forming a groove pair are configured to cooperatively receive an electrical conduit.
[0097] Clause 23. The connecting hub of Clause 22, each pair of grooves being disposed above a respective groove that spaces apart respective adjacent T-shaped formations.
[0098] Clause 24. The connection hub of any one of clauses 18 to 23, the connection hub being unitary.
[0099] Clause 25. The connection hub of Clause 18, further comprising a plurality of ridge couplers each engaging the outer circumferential surface of the cylindrical body, the plurality of ridge couplers comprising the plurality of grooves.
[0100] Clause 26. The connection hub of Clause 25, each ridge coupler comprising a stopper projecting toward the longitudinal axis, the stopper preventing longitudinal translation of the ridge coupler relative to the cylindrical body in a first direction.
[0101] Clause 27. The connection hub of any of clauses 25 to 26, each ridge coupler partially offset from the cylindrical body along the longitudinal axis such that each ridge coupler cantilevers from the cylindrical body.
[0102] Clause 28. The connection hub according to any one of clauses 25 to 27, the cylindrical body comprising a plurality of fins radially arranged around the outer circumferential surface of the cylindrical body, with respective ridge couplers received between adjacent fins.
[0103] Clause 29. The connection hub of any one of clauses 18 to 28, the plurality of grooves being shaped to correspond to a shape of the proximal end or the distal end of the ridge of the end effector.
[0104] The above examples are cited by way of example, and the disclosed technology is not limited to what is specifically shown and described above. On the contrary, the scope of the disclosed technology includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.
Claims
1. An end effector for a medical device, the end effector comprising: a plurality of ridges extending along the longitudinal axis and configured to move between an expanded configuration and a collapsed configuration, each ridge comprising a proximal end and a distal end; a plurality of electrodes connected to each ridge; a connecting hub defining a hub lumen and comprising a first terminal end, a second terminal end, and a plurality of grooves radially disposed around an outer circumferential surface of the connecting hub and extending parallel to the longitudinal axis, each groove opening along the longitudinal axis at or proximal to the first terminal end, each groove cooperating with one of the proximal end and the distal end of a corresponding ridge of a plurality of ridges to prevent relative movement between the connecting hub and the ridge; and An actuator member is connected to the connecting hub and the plurality of ridges such that translation of the actuator member along the longitudinal axis moves the ridges from the expanded configuration to the collapsed configuration.
2. The end actuator according to claim 1, when the corresponding groove receives the one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the corresponding groove in a direction parallel to the longitudinal axis.
3. The end actuator according to claim 1, when the corresponding groove receives the one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the corresponding groove in a direction perpendicular to the longitudinal axis.
4. The end actuator according to claim 1 further comprises a connector tube extending parallel to the longitudinal axis and extending through the hub inner cavity from the proximal end of the plurality of ridges to the distal end of the plurality of ridges, the connector tube defining a connector tube inner cavity.
5. The end effector according to claim 1, further comprising: a flushing tube extending along the longitudinal axis, The actuator member includes a puller wire extending through the irrigation tube and connected to the distal ends of the plurality of ridges, the puller wire being configured to move the plurality of ridges between the expanded configuration and the collapsed configuration.
6. The end effector according to claim 1, further comprising: a flushing tube extending along the longitudinal axis, The actuator member includes an actuator rod extending through the irrigation tube and connected to the distal ends of the plurality of ridges, the actuator rod being configured to move the plurality of ridges between the expanded configuration and the collapsed configuration.
7. The end effector according to claim 6, wherein the actuator rod defines an actuator rod lumen, and the actuator rod lumen is configured for a guide wire or a mapping catheter to pass through the actuator rod lumen.
8. The end effector of claim 1, further comprising a proximal tubular housing that mates with the connecting hub along the longitudinal axis.
9. The end effector of claim 8, wherein the proximal tubular housing extends through the hub lumen.
10. The end effector of claim 8, the connecting hub defining a plurality of hub grooves, and the proximal tubular housing comprising a plurality of housing grooves aligned with the plurality of hub grooves along the longitudinal axis.
11. A connection hub for an end effector of a medical device, the connection hub comprising: The first terminal; a second terminal, the second terminal being opposite to the first terminal; a cylindrical body defining a hub lumen and extending along a longitudinal axis from the first terminal end to the second terminal end; and A plurality of grooves are radially arranged around the outer circumferential surface of the cylindrical body and extend parallel to the longitudinal axis, each groove opens at the first terminal or proximal to the first terminal along the longitudinal axis, and each groove is configured to cooperate with the proximal end or distal end of the ridge of the end actuator.
12. The connection hub according to claim 11, each groove being defined in the outer circumferential surface of the cylindrical body.
13. The connecting hub of claim 11, wherein adjacent grooves define T-shaped formations therebetween, and each groove separates adjacent T-shaped formations.
14. The connecting hub of claim 13, the opposed upper sides of each T-shaped formation respectively defining a groove, wherein adjacent grooves of adjacent T-shaped formations forming a groove pair are configured to cooperatively receive an electrical conduit.
15. The connecting hub of claim 14, each pair of grooves being disposed above a respective groove that spaces apart respective adjacent T-shaped formations.
16. The connection hub of claim 11 further comprising a plurality of ridge couplers each engaging the outer circumferential surface of the cylindrical body, the plurality of ridge couplers comprising the plurality of grooves.
17. The connecting hub of claim 16, each ridge coupler including a stopper projecting toward the longitudinal axis, the stopper preventing longitudinal translation of the ridge coupler relative to the cylindrical body in a first direction.
18. The connection hub of claim 16, each ridge coupler partially offset from the cylindrical body along the longitudinal axis such that each ridge coupler cantilevers from the cylindrical body.
19. The connection hub of claim 16, said cylindrical body comprising a plurality of fins radially disposed about said outer circumferential surface of said cylindrical body, with corresponding ridge couplers received between adjacent fins.
20. The connecting hub of claim 11, the plurality of grooves being shaped to correspond to a shape of the proximal end or the distal end of the ridge of the end effector.
Citation Information
Patent Citations
Pulse Generator for Irreversible Electroporation
US20210161592A1
Using reversible electroporation on cardiac tissue
US20210162210A1
Generating and interleaving of irreversible-electroporation and radiofrequnecy ablation (ire / RFA) waveforms
US20210169550A1
Irreversible-electroporation (IRE) balloon catheter with membrane-insulated high-voltage balloon wires
US20210169567A1
Oriented irreversible-electroporation (IRE) pulses to compensate for cell size and orientation
US20210169568A1