Medical probe end effector with hinges
The medical probe end effector with a crown and spines connected by hinges of different materials addresses the issues of bulkiness and spine failure in basket catheters, ensuring reliable and effective ablation procedures for cardiac arrhythmias.
Patent Information
- Application Number
- JP2024090527
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-06
- Filing Date
- 2024-06-04
- Publication Date
- 2024-12-17
AI Technical Summary
Existing basket catheters for treating cardiac arrhythmias face challenges such as bulkiness, difficulty in insertion, and spine failure due to metal fatigue, which can lead to ineffective ablation procedures.
A medical probe end effector design featuring a crown, spines, and hinges made of different materials, allowing the basket assembly to transition between collapsed and expanded configurations, reducing stress concentrations and enhancing durability.
The design improves the reliability and ease of insertion of basket catheters by minimizing spine failure and maintaining structural integrity during deployment, thereby enhancing the effectiveness of ablation procedures.
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Figure 2024174848000001_ABST
Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to earlier U.S. Provisional Patent Application No. 63 / 506,275, filed June 5, 2023 (Attorney Docket No. BIO6844USPSP1-253757.000370), the entire contents of which are incorporated herein by reference.
[0002] FIELD OF THEINVENTION The present invention relates generally to medical devices, and more particularly to a basket catheter configured to transition between a collapsed configuration and an expanded configuration. [Background technology]
[0003] Cardiac 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 asynchronous rhythms. Certain procedures that exist to treat arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By selectively ablating cardiac tissue with the application of energy via a catheter, it is sometimes possible to stop or change the propagation of undesired electrical signals from one part of the heart to another. Medical probes may utilize radio frequency (RF) electrical energy to heat tissue. Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.
[0004] Regions of cardiac tissue can be mapped by the catheter to identify abnormal electrical signals. Ablation can be performed using the same or different catheters. Some exemplary catheters include multiple spines with electrodes disposed thereon. The electrodes are generally attached to the spines and fixed in place by soldering, welding, or using adhesives. Furthermore, multiple linear spines are generally assembled together by attaching both ends of the linear spine to a tubular shaft (e.g., a pusher tube) to form a spherical basket. Some basket catheters take up a lot of space and can be difficult to insert through the insertion catheter. Furthermore, due to the configuration of the basket and / or metal fatigue, the spines can break when inserted or retracted through a sheath or when manipulated over a period of time. Thus, there is a need in the art for alternative designs of basket catheters that help reduce the likelihood of spines breaking. These and other problems can be addressed by the techniques disclosed herein. Summary of the Invention [Means for solving the problem]
[0005] The disclosed technology includes a joint for an end effector of a medical probe. The end effector can include a crown, at least one spine, and at least one hinge. The at least one spine can extend along a longitudinal axis, include a deployed position and a delivery position relative to the longitudinal axis, and can include a first material. The at least one hinge can couple the at least one spine to the crown and can include a second material different from the first material.
[0006] The disclosed technology includes a medical probe. The medical probe can include a tubular shaft and an end effector. The tubular shaft can define a longitudinal axis and have a tubular shaft end. The end effector can be coupled to the tubular shaft end. The end effector can include a crown, at least one spine, and at least one hinge. The at least one spine extends along the longitudinal axis, includes a deployed position and a delivery position relative to the longitudinal axis, and can include a first material. The at least one hinge can couple the at least one spine to the crown and can include a second material different from the first material.
[0007] The disclosed technology includes a medical probe. The medical probe can include a tubular shaft and an end effector. The tubular shaft can define a longitudinal axis and have a tubular shaft end. The end effector can include at least one spine extending along the longitudinal axis, can include a deployed position and a delivery position relative to the longitudinal axis, and can include a first material. At least one hinge can couple the at least one spine to the tubular shaft end and can include a second material different from the first material.
[0008] The techniques of the present disclosure can include a method of constructing a joint of an end effector. The method can include disposing a tube over a portion of a spine or a portion of a crown. The method can include disposing the crown and the spine proximal to one another to define a gap. The method can include disposing a tube over the gap. The method can include heating the tube. The method can include, in response to heating, shrinking the tube to cover a spine distal end of the spine and a crown end of the crown.
[0009] The disclosed techniques can include a method of constructing an end effector joint. The method can include disposing a polymeric material over substantially an entire crown. The method can include disposing a distal end of a spine within a portion of the polymeric material and proximal to the crown to define a gap between the spine and the crown. The method can include heating the polymeric material. In response to heating, the method can include shrinking the polymeric material to cover the distal end of the spine and substantially all of the crown. [Brief description of the drawings]
[0010] [Figure 1] 1 is a schematic, pictorial, illustrative illustration of a medical system including a medical probe, the distal end of which has a basket assembly having electrodes coupled thereto, according to one embodiment of the disclosed technology; [Diagram 2] FIG. 1 is a perspective view of an expandable basket assembly in a deployed position in accordance with the disclosed technology. [Figure 3A] FIG. 13 is a detailed view of a spine in delivery position in accordance with the disclosed technology. [Figure 3B] FIG. 13 is a detailed view of a spine in a deployed position in accordance with the disclosed technology. [Figure 4A] FIG. 13 is a detailed side view of a spine in delivery position in accordance with the disclosed technology. [Figure 4B] FIG. 13 is a detailed view of a spine in a deployed position in accordance with the disclosed technology. [Diagram 5] FIG. 13 is a detailed side view of an example hinge interconnecting a spine and a crown portion in accordance with the techniques of this disclosure. [Figure 6] FIG. 13 is a perspective view of a portion of an expandable basket assembly with an exemplary hinge and an exemplary coupling member in accordance with the disclosed technology. [Figure 7] FIG. 13 is a perspective view of a portion of an expandable basket assembly with an exemplary hinge and another exemplary coupling member in accordance with the technology of the present disclosure. [Figure 8]FIG. 13 is a perspective view of a portion of an expandable basket assembly with another exemplary hinge in accordance with the technology of the present disclosure. [Figure 9] 9 is a detailed side view of the example hinge of FIG. 8 interconnecting the spine and crown portion in accordance with the techniques of the present disclosure. [Figure 10] FIG. 13 is a detailed side view of another example hinge in accordance with the techniques of this disclosure. [Figure 11] 1 is a detailed view of another example hinge in accordance with the techniques of this disclosure. [Figure 12A] FIG. 13 is a side schematic view of an expandable basket assembly including a plug and a force sensor in a first position in accordance with the disclosed technology. [Figure 12B] FIG. 13 is a side schematic view of an expandable basket assembly including a plug and a force sensor in a second position in accordance with the technology of the present disclosure. [Figure 12C] FIG. 13 is a side schematic view of an expandable basket assembly including a plug and a force sensor in a third position in accordance with the technology of the present disclosure. [Figure 13] 13 is a flow chart of a method of constructing a joint of an expandable basket assembly in accordance with the disclosed technology. [Figure 14] 13 is a flowchart of another method of constructing a joint of an expandable basket assembly in accordance with the techniques of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.
[0012] As used herein, the term "about" or "approximately" in relation to any numerical value or range indicates a suitable dimensional tolerance that enables a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited value, for example, "about 90%" may refer to a range of values of 71% to 110%.
[0013] As used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the use of the system or method to humans, although the use of the present invention in subjects in human patients represents a preferred embodiment. In addition, the vasculature of the "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals, and the like. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, and the like) that has been specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.
[0014] As discussed herein, a "physician" or "operator" may include a physician, surgeon, engineer, scientist, or any other individual or delivery instrument associated with the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.
[0015] As discussed herein, the term "ablate" or "ablation", in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features that are configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA), throughout this disclosure. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue in certain conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.
[0016] As discussed herein, the terms "bipolar" and "monopolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes, both placed at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Monopolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode containing a high current density and high electric flux density is placed at the treatment site, and a second electrode containing a relatively low current density and lower electric flux density is placed remotely from the treatment site.
[0017] As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to the respective electrical signals. A "biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as a "positive phase") and a negative voltage phase pulse (referred to herein as a "negative phase"). A "monophasic pulse" refers to an electrical signal that includes only a positive phase or only a negative phase. Preferably, a system that provides a biphasic pulse is configured to prevent application of a direct current voltage (DC) to a patient. For example, the average voltage of a biphasic pulse may be zero volts relative to ground or other common reference voltage. Additionally or alternatively, the system may include a capacitor or other protective component. When voltage amplitudes of a biphasic pulse and / or a monophasic pulse are described herein, it is understood that the expressed voltage amplitude is the absolute value of the approximate peak amplitude of each of the positive and / or negative voltage phases. Each phase of a biphasic pulse and a monophasic pulse preferably has a square shape that includes an essentially constant voltage amplitude for the majority of the phase duration. The phases of the biphasic pulse are separated in time by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of a phase of the biphasic pulse. The interphase delay duration is more preferably about 25% of the duration of a phase of the biphasic pulse.
[0018] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure may generally be illustrated as a substantially right cylindrical structure, although the tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.
[0019] Exemplary systems, methods, and devices of the present disclosure may be particularly suited for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically provided to the cardiac tissue by electrodes capable of delivering the ablation energy along the tissue to be ablated. Ablation procedures incorporating such exemplary catheters may be visualized using fluoroscopy.
[0020] Ablation of cardiac tissue, applying radio frequency (RF) energy and thermal techniques such as cryoablation, to improve a failing heart, is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation.
[0021] IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures in the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which would be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.
[0022] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) generation of pores in the cell membrane. Cells have a transmembrane electrostatic potential that increases above the resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can self-repair and survive. If the transmembrane electrostatic potential increases above a threshold potential, electroporation is irreversible and the cell becomes permanently permeable. As a result, the cell dies due to loss of homeostasis, typically by programmed cell death or apoptosis, which is believed to leave less scar tissue compared to other ablation modalities. In general, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potential.
[0023] We now turn to the manufacture and construction of a medical probe capable of IRE as discussed above. The solutions of the present disclosure include systems and methods for constructing a basket assembly. By connecting multiple spine struts to the crown of the distal tip with a hinge, the basket assembly can be configured to transition between a deployed position and a delivery position. Additionally, the hinge allows the basket assembly to form a more compact shape when in the delivery position. Additionally, the hinge reduces stress concentrations that may exist in the spine, thereby reducing the likelihood that the spine may break when bent.
[0024] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple medical probes (catheters) that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. The multiple medical probes can then be inserted into the delivery sheath catheter to reach the desired location. The multiple medical probes 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 medical probe 14 configured to sense IEGMs is illustrated herein. The physician 24 brings a distal tip 28 of the medical probe 14 into contact with the heart wall to sense a target site of the heart 12. For ablation, the physician 24 similarly brings a distal end of an ablation catheter to a target site for ablation.
[0025] The medical probe 14 may be an exemplary catheter including one or preferably multiple electrodes 103 ( FIG. 2 ) optionally distributed on multiple spines 101 (surrounded by an insulating jacket 102) at a distal tip 28 and configured to sense IEGM signals. The medical probe 14 may further include a position sensor 29 embedded in or near the distal tip 28 for tracking the position and orientation of the distal tip 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.
[0026] The magnetic-based position sensor 29 may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the distal tip 28 of the medical probe 14 may be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,391,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091.
[0027] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.
[0028] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.
[0029] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes at the distal tip 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 unipolar or bipolar high voltage direct current pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.
[0030] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple 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 capabilities for implementing real-time calculations of the catheter positions and performing ECG calculations.
[0031] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 55 may optionally provide multiple functions including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual representation or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (4) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.
[0032] 2 is a perspective view of a distal tip 28 in accordance with the disclosed technology. The distal tip 28 may be configured as an expandable basket assembly 100 (also referred to herein as an "end effector" and a "basket assembly"). The basket assembly 100 may be connected to a tubular shaft 36 that defines a longitudinal axis 60. As shown in FIG. 2, the basket assembly 100 may include a plurality of spines 101 that extend along (i.e., substantially parallel to) the longitudinal axis 60 in a delivery position (i.e., a collapsed position) and arc radially outward from the longitudinal axis 60 in a deployed position (i.e., an expanded position forming a generally spherical or generally oblate spheroidal shape).
[0033] The spine 101 can have an insulating jacket 102 disposed over a portion thereof. The spine 101 can include a first material. In some examples, the first material can include Nitinol, cobalt chrome, stainless steel, titanium, or another elastic biocompatible material, such as a polymeric material.
[0034] The spine 101 may further include a plurality of electrodes 103 disposed thereon, which may be configured for mapping electrophysiological signals and / or ablation of tissue. The electrodes 103 may be any type of electrode configured including, but not limited to, suitable for sensing electrophysiological signals, ablation, position sensing, reference electrodes, etc. The electrodes 103 may be ring-shaped electrodes, bulging electrodes, rectangular electrodes, circular electrodes, etc. Additionally, the electrodes 103 may be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
[0035] The spines 101 may be attached at one end to the distal end of the tubular shaft 36 and at the opposite end to the crown 110 to allow them to move between a delivery position and a deployed position relative to the longitudinal axis 60. As used herein, "crown" refers to a structure that serves as an attachment point for one or more spines 101 at their distal ends. In some examples, the crown 110 may also include a first material (e.g., Nitinol). The crown 110 may be configured in a number of ways in accordance with the techniques of this disclosure. In some examples, the crown 110 may include a central crown hub 111 and a number of protrusions 112 that protrude away from the hub. The protrusions 112 may be approximately flush with the central hub 111. In other examples, the crown 110 may exclude the protrusions 112.
[0036] The joint between each spine 101 and the crown 110 is an area that flexes in response to movement of the basket assembly 100 between the delivery position and the deployed position. To reduce or eliminate fatigue at this joint, the basket assembly 100 may further include a hinge 120 disposed between each spine 101 and the crown 110 to couple them together.
[0037] Each hinge 120 can include a second material that is different from the first material of the spine 101. In some examples, the second material includes a flexible material that can withstand repeated bending without experiencing fatigue and / or breakage. For example, the second material can include, but is not limited to, a polymer, such as a polyolefin, a polymeric metal, or a polyester. Other exemplary second materials are provided below.
[0038] 3A and 3B are detailed perspective views showing spine 101 bending between a delivery position (FIG. 3A) and a deployed position (FIG. 3B). FIGS. 4A and 4B are detailed side views thereof. As shown, the spine distal end joins one side of hinge 120 and the crown spine portion joins the other side of hinge 120. In some examples, each projection 112 can include a width at its proximal end approximately equal to the width of the spine distal end.
[0039] In some examples, each hinge 120 can be coupled to a respective protrusion 112 of the crown. In other examples, the hinges 120 can be coupled to the crown hub 111 (e.g., when some or all of the protrusions 112 are omitted). As shown by the directional arrows in FIGS. 4A and 4B, when the spine 101 is bent outward (to the position shown in FIG. 4B), the spine rotates from a first angle θ1 to a second, larger angle θ2 relative to the crown 110. In some embodiments, the first angle θ1 can be about 90 degrees. In some examples, θ2 can be any range between about 90 degrees and about 180 degrees. In some examples, θ2 can be in the range of about 90° to about 130°.
[0040] FIG. 5 is a detailed cutaway view illustrating an example hinge 120 in accordance with the techniques of the present disclosure. As shown, the spine distal end and the crown spine portion (e.g., crown projection 112) are separated by a hinge gap 70. The gap 70 correlates to the maximum offset that the crown 111 can have when compressed. In some examples, the gap 70 can be a distance of about 1-5 millimeters. In some examples, the gap 70 can be approximately equal to the thickness of the spine 101 that allows the spine 101 to fold without interfering with each other. This hinge gap 70 is at least covered by the hinge 120. In some examples, the hinge 120 is formed (e.g., can be formed from a flexible material that can be compressed and / or expanded when a force is applied) to allow the crown spine portion and the spine distal end to move toward and away from each other.
[0041] 4A-5, the hinge 120 can include a cap 123. In some examples, the cap 123 can include a shrinkable tube (e.g., heat shrink). The shrinkable tube can be placed over the crown 110 and a portion of the spine 101 to cover any sharp edges that may otherwise be exposed. In some examples, the cap 123 can be formed as a Nitinol tube, a stainless spring steel tube, a PEEK tube, or a laminate material that covers the hinge gap 70.
[0042] 5, the linking member 121 can extend at least partially through the hinge 120 to prevent the spine 101 and crown 110 from being pulled apart by more than the gap 70. The linking member 121 can be coupled to the spine 101 and crown 111 in a variety of ways. For example, one or more anchor points 122 can be provided at the distal end of the spine 101 to which an end of the linking member 121 is attached (e.g., via an adhesive or mechanical connection). Additionally, an opening 113 can be defined in the crown 110 (e.g., defined in the protrusion 112) through which the linking member 112 is threaded. Alternatively, this coupling configuration can be reversed.
[0043] Additionally, an adhesive 124 may be filled into the hinge 120 to at least partially hold the hinge to the spine 101 and crown 110. In some examples, the hinge 120 may include a connecting member 121 and / or an adhesive 124.
[0044] In some examples, the linking member 121, as shown in Figure 6, can include a flexible material 121A, such as, but not limited to, yarn (e.g., polyester yarn), Nitinol, manufactured fibers spun from liquid crystal polymers, molded thermoplastic bonds such as PEBAX (Copyright), nylon-based, stainless steel wire, and carbon-based fibers. In some examples, as shown in Figure 7, the linking member 121 can include a plurality of links 121B flexibly interconnected to one another.
[0045] 8 and 9, rather than providing a cap 123 at each joint between the spine 101 and crown 110, a hinge 120A can be provided that covers substantially all of the crown and spine ends. The hinge 120A can include a cap 123A that is overmolded onto the crown 110 and the ends of the spine 101. Similar to the cap 123 previously described, this cap 123A can also have an adhesive 124 filled therein.
[0046] 10 is a detailed side view of another exemplary hinge 120B. In this example, hinge 120B may be formed from a flexible material and directly connected to the distal tip of crown 110 (e.g., distal tip of prong 112) and spine 101, rather than covering the ends of crown 110 and spine 101.
[0047] 11, another exemplary hinge 120C is shown. It can be structured similarly to other examples described (e.g., those described with respect to FIG. 5). However, the hinge 120C can also be used at other points on the basket assembly 100, such as connecting the spine 101 to the tubular shaft 36, rather than joining the crown 110 to the spine 101 to one another. In this example, various electrical connections 104 (e.g., wires) can be routed through the hinge 120C to electrically connect the electrodes 103 with the electrophysiological equipment.
[0048] In addition to the exemplary hinge 120 described above, the present disclosure provides a method for measuring the force applied by the crown 110 to tissue in the patient 23. FIGS. 12A-12C illustrate side schematic views of an expandable basket assembly 200 including a plug 201 and a force sensor 203 disposed in various positions. The plug 201 may be coupled to the tubular shaft 36 at its proximal end and may include an irrigation hole 202 at its distal end. At the distal end, the force sensor 203 may slidably and rotatably extend and be coupled to the bottom side of the crown 110. As shown in FIGS. 12A-12B and 12C, when in the delivery position, the force sensor 203 may extend a distance y0 into the plug 201 and be substantially coaxial with the longitudinal axis 60.
[0049] As the spine 101 expands, the force sensor 203 is pushed down into the plug 201 a distance y1. Additionally, as the crown 110 or spine 101 contacts tissue, the crown can be angularly deflected as shown by angle θ3 in FIG. 12B. For example, by pushing the crown 110 further, the force sensor 203 can be pushed further into the plug 201 a distance y2. When the crown 110 is fully depressed onto the distal end of the plug 201, it can block the irrigation hole 202 as shown in FIG. 12C. The measured distances y0, y1, and y2 and angle θ3 can be used to calculate various parameters associated with the basket assembly 200, such as the force and vectors contacting the patient's tissue.
[0050] FIG. 13 is a flow chart of a method 1300 of constructing a joint of an expandable basket assembly according to the techniques of the present disclosure. The basket assembly can include all of the same features as the basket assembly described further herein. The method 1300 can include disposing 1302 a tube over a portion of the spine or a portion of the crown. The method 1300 can include disposing 1304 a crown and a spine proximal to one another to define a gap. The method 1300 can include disposing 1306 a tube over the gap. The method 1300 can include heating 1308 the tube. The method 1300 can include shrinking 1310 the tube in response to heating to cover the spine distal end of the spine and the crown end of the crown. In some examples, the method can include filling the tube with an adhesive. In some examples, the method 1300 can include bonding a bonding member to the spine and the crown. In some examples of the method 1300, the bonding member can include a polyester thread or a plurality of interconnected flexible links. In some examples, the method 1300 may further include defining a hole in the crown end.
[0051] FIG. 14 is a flow chart of another method 1400 of constructing a joint of an expandable basket assembly according to the techniques of the present disclosure. The basket assembly can include all of the same features as the basket assembly described further herein. The method 1400 can include disposing 1402 a polymeric material over substantially all of the crown. The method 1400 can include disposing 1404 a distal end of the spine proximal to the crown within a portion of the polymeric material to define a predetermined gap between the spine and the crown. The method 1400 can include heating 1406 the polymeric material. The method 1400 can include shrinking 1408 the polymeric material in response to heating to cover the spine distal end and substantially all of the crown. In some examples, the method 1400 can include filling the polymeric material with an adhesive.
[0052] As will be appreciated by those skilled in the art, methods 1300 and 1400 can include any of the various features of the disclosed techniques described herein and may vary depending on the particular configuration, and thus methods 1300 and 1400 should not be construed as limited to the particular steps and order of steps explicitly described herein.
[0053] The techniques of the present disclosure described herein can be further understood according to the following sections.
[0054] Item 1: A joint of an end effector of a medical probe, the end effector comprising: a crown; at least one spine extending along a longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the at least one spine comprising a first material; and at least one hinge coupling the at least one spine to the crown, the at least one hinge comprising a second material different from the first material.
[0055] Clause 2: A joint of an end effector described in clause 1, wherein at least one spine is expandable from a delivery position in which the at least one spine is substantially parallel to the longitudinal axis to a deployed position in which the at least one spine bends outward from the longitudinal axis, and wherein the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position.
[0056] Clause 3: A joint of an end effector described in any one of clauses 1 to 2, wherein at least one spine has a spine distal end, the crown has at least one crown spine portion, and at least one hinge connects the spine distal end to the at least one crown spine portion.
[0057] Clause 4: A joint of the end effector described in clause 3, wherein the crown spine portion and the spine distal end are separated by a hinge gap, the hinge gap being at least covered by a hinge.
[0058] Clause 5: A joint of the end effector described in clause 4, wherein the hinge gap comprises a distance in the range of approximately 1 to 5 millimeters.
[0059] Clause 6: A joint of an end effector described in clause 4 or clause 5, wherein the second material of at least one hinge enables at least one crown spine portion and the spine distal end to move toward and away from each other.
[0060] Clause 7: A joint of an end effector described in any one of clauses 1 to 6, wherein the crown has a central hub and the crown spine portion defines at least one protrusion that protrudes away from the hub.
[0061] Clause 8: A joint of an end effector as described in clause 7, wherein at least one protrusion includes a width at a proximal end of the at least one protrusion that is approximately equal to a width at a distal end of the spine.
[0062] Clause 9: A joint of an end effector described in clause 7 or clause 8, wherein at least one protrusion is generally coplanar with the central hub.
[0063] Clause 10: A joint of an end effector described in any one of clauses 1 to 9, further comprising at least one connecting member extending at least partially through the at least one hinge.
[0064] Clause 11: A joint of the end effector described in clause 10, wherein the crown defines at least one opening, and the at least one coupling member extends through the at least one opening to couple the at least one coupling member to the crown.
[0065] Clause 12: A joint of an end effector described in clause 10 or clause 11, wherein at least one spine includes at least one anchor point to which an end of at least one connecting member is connected.
[0066] Clause 13: A joint of an end effector described in any one of clauses 10 to 12, wherein at least one spine includes two anchor points to which an end of at least one connecting member is connected.
[0067] Item 14: A joint of an end effector described in any one of items 10 to 13, wherein at least one connecting member comprises polyester thread.
[0068] Clause 15: A joint of an end effector described in any one of clauses 11 to 14, wherein at least one connecting member comprises a plurality of flexibly interconnected links.
[0069] Item 16: A joint of an end effector described in any one of items 1 to 9, wherein the second material includes polyester yarn.
[0070] Clause 17: A joint of an end effector described in any one of clauses 1 to 9, wherein the hinge comprises a plurality of flexibly interconnected links.
[0071] Clause 18: At least one hinge connects a contractible tube to a joint of an end effector described in any one of clauses 1 to 17.
[0072] Clause 19: A joint of the end effector described in clause 18, wherein an end of the contractible tube is disposed over a portion of the crown and a portion of the at least one spine.
[0073] Clause 20: A joint of an end effector described in clause 18 or clause 19, wherein the second material comprises a polyolefin.
[0074] Clause 21: A joint of an end effector described in any one of clauses 1 to 17, wherein at least a portion of at least one hinge is overmolded onto the crown and the end of at least one spine.
[0075] Clause 22: The joint of the end effector described in clause 21, wherein the second material comprises a contractible material.
[0076] Item 23: A joint of an end effector described in any one of items 1 to 22, further comprising an adhesive that holds at least one hinge in place.
[0077] Item 24: A joint of an end effector described in any one of items 1 to 23, wherein the first material includes Nitinol.
[0078] Item 25: A joint of an end effector described in any one of items 1 to 24, wherein the crown comprises Nitinol.
[0079] Clause 26: A joint of an end effector described in any one of clauses 1 to 25, wherein at least one spine has at least one electrode coupled thereto.
[0080] Clause 27: A joint of an end effector as described in clause 26, wherein the at least one electrode is configured to electrophysiologically map tissue, ablate the tissue, or both map and ablate the tissue.
[0081] Item 28: A medical probe comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; and an end effector coupled to the tubular shaft end, the end effector comprising a crown, at least one spine extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the at least one spine comprising a first material; and at least one hinge coupling the at least one spine to the crown, the at least one hinge comprising a second material different from the first material.
[0082] Clause 29: A medical probe as described in clause 28, wherein at least one spine is expandable from a delivery position in which the at least one spine is substantially parallel to the longitudinal axis to a deployed position in which the at least one spine bends outward from the longitudinal axis, and the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position.
[0083] Clause 30: A medical probe as described in clause 28 or clause 29, wherein at least one spine has a spine distal end, the crown has at least one crown spine portion, and at least one hinge connects the spine distal end to the at least one crown spine portion.
[0084] Clause 31: The medical probe of clause 30, wherein the crown spine portion and the spine distal end are separated by a hinge gap, the hinge gap being at least covered by the hinge.
[0085] Clause 32: The medical probe of clause 31, wherein the hinge gap comprises a distance in the range of approximately 1 to 5 millimeters.
[0086] Clause 33: A medical probe as described in clause 31 or clause 32, wherein the second material of at least one hinge enables at least one crown spine portion and the spine distal end to move towards and away from each other.
[0087] Clause 34: A medical probe as described in any one of clauses 28 to 33, wherein the crown includes a central hub, and the crown spine portion defines at least one protrusion that projects away from the hub.
[0088] Clause 35: The medical probe of clause 34, wherein the at least one protrusion includes a width at a proximal end of the at least one protrusion that is approximately equal to a width of the spine distal end.
[0089] Clause 36: A medical probe as described in clause 34 or 35, wherein at least one protrusion is approximately coplanar with the central hub.
[0090] Item 37: The medical probe of any one of items 28 to 36, further comprising at least one coupling member extending at least partially through the at least one hinge.
[0091] Clause 38: The medical probe described in clause 37, wherein the crown defines at least one opening, and the at least one coupling member extends through the at least one opening to couple the at least one coupling member to the crown.
[0092] Clause 39: A medical probe as described in clause 37 or clause 38, wherein at least one spine includes at least one anchor point to which an end of at least one coupling member is coupled.
[0093] Clause 40: The medical probe according to any one of clauses 37 to 39, wherein at least one spine has two anchor points to which an end of at least one coupling member is coupled.
[0094] Item 41: The medical probe of any one of items 37 to 40, wherein at least one binding member includes a polyester thread.
[0095] Clause 42: The medical probe of any one of clauses 38 to 41, wherein at least one coupling member comprises a plurality of flexibly interconnected links.
[0096] Item 43: A medical probe described in any one of items 28 to 36, wherein the second material includes polyester thread.
[0097] Item 44: A medical probe described in any one of items 28 to 36, wherein the hinge comprises a plurality of flexibly interconnected links.
[0098] Item 45: A medical probe as described in any one of items 28 to 44, wherein at least one hinge comprises a contractible tube.
[0099] Clause 46: A medical probe as described in clause 45, wherein an end of the shrinkable tube is positioned over a portion of the crown and a portion of at least one spine.
[0100] Item 47: A medical probe as described in item 45 or 46, wherein the second material includes a polyolefin.
[0101] Clause 48: A medical probe described in any one of clauses 28 to 44, wherein at least a portion of at least one hinge is overmolded onto the crown and the end of at least one spine.
[0102] Clause 49: The medical probe of clause 48, wherein the second material includes a shrinkable material.
[0103] Item 50: The medical probe of any one of items 28 to 49, further comprising an adhesive that holds the at least one hinge in place.
[0104] Item 51: The medical probe of any one of items 28 to 50, wherein the first material includes Nitinol.
[0105] Item 52: A medical probe according to any one of items 28 to 51, wherein the crown comprises Nitinol.
[0106] Item 53: The medical probe according to any one of items 28 to 52, wherein at least one spine has at least one electrode coupled thereto.
[0107] Clause 54: A medical probe as described in clause 53, wherein at least one electrode is configured to electrophysiologically map tissue, ablate tissue, or both map and ablate tissue.
[0108] Item 55: The medical probe according to any one of items 28 to 54, further comprising a central plug disposed proximal to at least one spine.
[0109] Clause 56: A medical probe as described in clause 55, wherein the central plug defines at least one hole, and the at least one spine or crown is configured to block the at least one hole when the at least one spine is in the deployed position.
[0110] Clause 57: The medical probe of clause 56, wherein at least one spine or crown is configured to engage a distal tip of the central plug to block at least one hole.
[0111] Clause 58: The medical probe described in clause 57, wherein the at least one spine or crown is configured to engage a distal tip of the central plug when the at least one spine is in the deployed position.
[0112] Clause 59: A medical probe as described in any one of clauses 55 to 59, further comprising a force sensor coupled to the central plug, the force sensor configured to measure a force applied to the distal tip by at least one spine or crown.
[0113] Clause 60: A medical probe comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; and an end effector extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the end effector comprising at least one spine comprising a first material; and at least one hinge coupling the at least one spine to the tubular shaft end, the at least one hinge comprising a second material different from the first material.
[0114] Clause 61: The medical probe of clause 60, wherein at least one spine has at least one electrode coupled thereto.
[0115] Item 62: A medical probe as described in item 60 or 61, comprising wiring extending through at least one hinge.
[0116] Clause 63: A method of constructing a joint of an end effector, the method including: placing a tube over a portion of a spine or a portion of a crown; positioning the crown and spine proximate to one another to define a gap; placing a tube over the gap; heating the tube; and in response to heating, causing the tube to shrink to cover a spine distal end of the spine and a crown end of the crown.
[0117] Clause 64: The method of clause 63, further comprising filling the tube with adhesive.
[0118] Clause 65: The method of clause 63 or clause 64, further comprising attaching a connecting member to the spine and crown.
[0119] Clause 66: The method of clause 65, wherein the connecting member comprises a polyester thread or a plurality of interconnected flexible links.
[0120] Clause 67: The method of any one of clauses 63 to 66, further comprising defining a hole in the crown end.
[0121] Clause 68: A method of constructing an end effector joint, the method including: disposing a polymeric material over substantially an entire crown; disposing a distal end of a spine within a portion of the polymeric material proximal to the crown so as to define a gap between the spine and the crown; heating the polymeric material; and, in response to heating, causing the polymeric material to shrink to cover the distal end of the spine and substantially all of the crown.
[0122] Item 69: The method of item 68, further comprising filling the polymeric material with an adhesive.
[0123] The above embodiments are cited by way of example, and the invention is not limited to what has been specifically shown and described hereinabove. Rather, the scope of the invention includes both combinations and subcombinations of the various features described and illustrated above, as well as variations and modifications thereof not disclosed in the prior art that will occur to those skilled in the art upon reading the foregoing description.
[0124] [Embodiment] (1) A joint for an end effector of a medical probe, the end effector comprising: Crown and at least one spine extending along a longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; and at least one hinge connecting the at least one spine to the crown, the at least one hinge comprising a second material different from the first material. (2) A joint of an end effector as described in embodiment 1, wherein the at least one spine is expandable from the delivery position in which the at least one spine is substantially parallel to the longitudinal axis to the deployed position in which the at least one spine bends outward from the longitudinal axis, and the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position. (3) A joint of an end effector as described in embodiment 1, wherein the at least one spine has a spine distal end, the crown has at least one crown spine portion, the at least one hinge connects the spine distal end to the at least one crown spine portion, the crown spine portion and the spine distal end being separated by a hinge gap, and the hinge gap is at least covered by the hinge. (4) A joint of an end effector as described in embodiment 3, wherein the crown has a central hub and the at least one crown spine portion defines at least one protrusion protruding away from the hub, the at least one protrusion having a width at a proximal end of the at least one protrusion approximately equal to a width at a distal end of the spine. (5) A joint of an end effector as described in embodiment 3, wherein the crown has a central hub and the at least one crown spine portion defines at least one protrusion protruding away from the hub, the at least one protrusion being approximately coplanar with the central hub.
[0125] (6) A joint of an end effector as described in embodiment 1, further comprising at least one linking member extending at least partially through the at least one hinge, the crown defining at least one opening, the at least one linking member extending through the at least one opening to link the at least one linking member to the crown, and the at least one spine comprising at least one anchor point to which an end of the at least one linking member is connected. (7) A joint of an end effector as described in embodiment 1, further comprising at least one linkage member extending at least partially through the at least one hinge, the at least one linkage member comprising polyester thread and / or a plurality of flexibly interconnected links. (8) A joint of an end effector as described in embodiment 1, wherein the at least one hinge comprises a contractible tube. (9) The joint of an end effector described in embodiment 1, wherein the first material and / or the crown comprises Nitinol. (10) A joint of an end effector as described in embodiment 1, wherein the at least one spine has at least one electrode coupled thereto, whereby the at least one electrode is configured to electrophysiologically map tissue, ablate the tissue, or both map and ablate the tissue.
[0126] (11) A medical probe, comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; an end effector coupled to the tubular shaft end, the end effector comprising: Crown and at least one spine extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; and at least one hinge coupling the at least one spine to the crown, the at least one hinge comprising a second material different from the first material. (12) The medical probe of claim 11, wherein the at least one spine is expandable from the delivery position in which the at least one spine is substantially parallel to the longitudinal axis to the deployed position in which the at least one spine bends outward from the longitudinal axis, and the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position. (13) The medical probe of embodiment 11, wherein the at least one spine comprises a spine distal end, the crown comprises at least one crown spine portion, the at least one hinge connects the spine distal end to the at least one crown spine portion, the crown spine portion and the spine distal end being separated by a hinge gap, and the hinge gap is at least covered by the hinge. (14) The medical probe of claim 13, wherein the crown comprises a central hub, and the at least one crown spine portion defines at least one protrusion that protrudes away from the hub, the at least one protrusion being generally coplanar with the central hub. (15) The medical probe of claim 11, further comprising at least one coupling member extending at least partially through the at least one hinge, the crown defining at least one opening, the at least one coupling member being flexible and extending through the at least one opening to couple the at least one coupling member to the crown, and the at least one spine comprising at least one anchor point to which an end of the at least one coupling member is coupled.
[0127] (16) The medical probe of embodiment 11, wherein the at least one spine has at least one electrode coupled thereto, whereby the at least one electrode is configured to electrophysiologically map tissue, ablate the tissue, or both map and ablate the tissue. (17) The medical probe of claim 11, further comprising a central plug disposed proximal to the at least one spine. (18) A medical probe, comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; An end effector, at least one spine extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; and at least one hinge coupling the at least one spine to the tubular shaft end, the at least one hinge comprising a second material different from the first material. (19) The medical probe of embodiment 18, wherein the at least one spine has at least one electrode coupled thereto. (20) The medical probe of claim 18, further comprising wiring extending through the at least one hinge.
Claims
1. 1. A joint for an end effector of a medical probe, the end effector comprising: Crown and at least one spine extending along a longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; at least one hinge connecting the at least one spine to the crown, the at least one hinge comprising a second material different from the first material.
2. 2. The joint of claim 1, wherein the at least one spine is expandable from the delivery position in which the at least one spine is substantially parallel to the longitudinal axis to the deployed position in which the at least one spine bends outward from the longitudinal axis, and the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position.
3. 2. The joint of claim 1, wherein the at least one spine comprises a spine distal end, the crown comprises at least one crown spine portion, the at least one hinge connects the spine distal end to the at least one crown spine portion, the crown spine portion and the spine distal end being separated by a hinge gap, the hinge gap being at least covered by the hinge.
4. 4. The joint of claim 3, wherein the crown includes a central hub and the at least one crown spine portion defines at least one protrusion projecting away from the hub, the at least one protrusion including a width at a proximal end of the at least one protrusion approximately equal to a width at a distal end of the spine.
5. 4. The joint of claim 3, wherein the crown includes a central hub and the at least one crown spine portion defines at least one protrusion projecting away from the hub, the at least one protrusion being generally coplanar with the central hub.
6. 2. The joint of claim 1, further comprising at least one linking member extending at least partially through the at least one hinge, the crown defining at least one opening, the at least one linking member extending through the at least one opening to couple the at least one linking member to the crown, and the at least one spine comprising at least one anchor point to which an end of the at least one linking member is coupled.
7. 10. The joint of claim 1, further comprising at least one linkage member extending at least partially through the at least one hinge, the at least one linkage member comprising polyester thread and / or a plurality of flexibly interconnected links.
8. The joint of claim 1 , wherein the at least one hinge comprises a shrinkable tube.
9. The joint of claim 1 , wherein the first material and / or the crown comprises Nitinol.
10. 2. The joint of an end effector according to claim 1, wherein the at least one spine has at least one electrode coupled thereto, whereby the at least one electrode is configured to electrophysiologically map tissue, ablate the tissue, or both map and ablate the tissue.
11. 1. A medical probe, comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; an end effector coupled to the tubular shaft end, the end effector comprising: Crown and at least one spine extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; at least one hinge connecting the at least one spine to the crown, the at least one hinge comprising a second material different from the first material; and
12. 12. The medical probe of claim 11, wherein the at least one spine is expandable from the delivery position in which the at least one spine is substantially parallel to the longitudinal axis to the deployed position in which the at least one spine bends outward from the longitudinal axis, and the at least one hinge bends in response to expansion of the at least one spine between the delivery position and the deployed position.
13. 12. The medical probe of claim 11, wherein the at least one spine comprises a spine distal end, the crown comprises at least one crown spine portion, the at least one hinge connects the spine distal end to the at least one crown spine portion, the crown spine portion and the spine distal end being separated by a hinge gap, and the hinge gap is at least covered by the hinge.
14. 14. The medical probe of claim 13, wherein the crown includes a central hub, the at least one crown spine portion defining at least one projection projecting away from the hub, the at least one projection being generally coplanar with the central hub.
15. 12. The medical probe of claim 11, further comprising at least one coupling member extending at least partially through the at least one hinge, the crown defining at least one opening, the at least one coupling member being flexible and extending through the at least one opening to couple the at least one coupling member to the crown, and the at least one spine comprising at least one anchor point to which an end of the at least one coupling member is coupled.
16. 12. The medical probe of claim 11, wherein the at least one spine has at least one electrode coupled thereto, whereby the at least one electrode is configured to electrophysiologically map tissue, ablate tissue, or both map and ablate tissue.
17. The medical probe of claim 11 , further comprising a central plug disposed proximally of the at least one spine.
18. 1. A medical probe, comprising: a tubular shaft defining a longitudinal axis and having a tubular shaft end; An end effector, at least one spine extending along the longitudinal axis and including a deployed position and a delivery position relative to the longitudinal axis, the spine including a first material; and at least one hinge coupling the at least one spine to the tubular shaft end, the at least one hinge comprising a second material different from the first material.
19. The medical probe of claim 18 , wherein the at least one spine has at least one electrode coupled thereto.
20. The medical probe of claim 18 comprising wiring extending through the at least one hinge.
