Patent Application
20230226336
The present invention relates generally to medical devices, and in particular catheters with electrodes, and further relates to, but not exclusively, catheters suitable for use to induce irreversible electroporation (IRE) of cardiac tissues.
Cardiac arrhythmias, such as atrial fibrillation (AF), occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythm. Certain procedures exist for treating arrhythmia, including surgically disrupting the origin of the signals causing the arrhythmia and disrupting the conducting pathway for such signals. By selectively ablating cardiac tissue by application of energy via a catheter, it is sometimes possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another.
Many current ablation approaches in the art tend to utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain drawbacks, such as heightened risk of thermal cell injury which can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that generally reduces thermal risks associated with RF ablation. Maneuvering cryoablation devices and selectively applying cryoablation, however, is generally more challenging compared to RF ablation; therefore cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.
Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using nonthermal ablation methods. IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes. Delivery of IRE energy to tissues using multi-electrode catheters was previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Pat. Pub. No. 2021/0169550A1, 2021/0169567A1, 2021/0169568A1, 2021/0161592A1, 2021/0196372A1, 2021/0177503A1, and 2021/0186604A1, each of which are incorporated by reference in their entirety into this application as if set forth in full and attached in the appendix to priority application U.S. 63/301,146.
Regions of cardiac tissue can be mapped by a catheter to identify the abnormal electrical signals. The same or different catheter can be used to perform ablation. Some example catheters include a number of spines with electrodes positioned thereon. The electrodes are generally attached to the spines and secured in place by soldering, welding, or using an adhesive. Due to the small size of the spines and the electrodes, however, soldering, welding, or adhering the electrodes to the spines can be a difficult task, increasing the manufacturing time and cost and the chances that the electrode fails due to an improper bond or misalignment. What is needed, therefore, are systems and methods of attaching an electrode to a spine of a basket assembly without the need for soldering, welding, or using adhesive.
There is provided, in accordance with an embodiment of the present invention, a medical probe, including an expandable basket assembly coupled to a distal end of a tubular shaft. The expandable basket assembly can include at least one spine and a plurality of electrode assemblies. The electrode assemblies can each include a first insulating portion and a second insulating portion that can electrically insulate the electrode from the spine. The electrode, the first insulating portion, and the second insulating portion can be interlocked onto a spine to prevent the electrode from sliding proximally or distally along a length of the spine. In this way, the presently disclosed technology can be used to secure the electrodes to the spines without requiring solder, weld, or adhesives.
The disclosed technology includes a medical probe including a tubular shaft having a proximal end and a distal end. The tubular shaft can extend along a longitudinal axis. The medical probe can further include an expandable basket assembly coupled to the distal end of the tubular shaft.
The expandable basket assembly can include at least one spine extending along the longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form. The expandable basket assembly can include a plurality of electrode assemblies. Each electrode assembly of the plurality of electrode assemblies can be attached to the at least one spine. Each electrode assembly can include an electrode, a first electrically insulating portion electrically isolating the electrode from the respective spine, and a second electrically insulating portion electrically isolating the electrode from the spine. The electrode, the first electrically insulating portion, and the second electrically insulating portion can be interlocked onto the spine such that the plurality of electrode assemblies are prevented from sliding proximally or distally along a length of the spine.
The spine can include a retainer ring onto which a respective electrode assembly of the plurality of electrode assemblies is interlocked. The electrode can include a protrusion that is configured to interlock with the second electrically insulating portion. The protrusion can extend through the retainer ring, thereby preventing the electrode assembly from sliding along the length of the spine. The protrusion can include a swage fitting.
The first electrically insulating portion can include a first washer and the second electrically insulating portion can include a second washer. The first washer and the second washer can be configured to prevent the electrode from contacting the spine and to electrically isolate the electrode from the spine. The second washer can include a lip that is configured to extend inwardly into the retainer ring to prevent the electrode from contacting the spine.
The first electrically insulating portion can be a first housing portion and the second electrically insulating portion can be a second housing portion. The first housing portion and the second housing portion can be configured to interlock to secure the electrode to the spine. The second housing portion can include a male connector and the first housing portion can include a female connector configured receive the male connector and facilitate the first housing portion to interlock with the second housing portion. Alternatively, the first housing portion can include a male connector and the second housing portion can include a female connector configured receive the male connector and facilitate the first housing portion to interlock with the second housing portion.
The first housing portion can include a rim that is configured to receive the electrode. The electrode can further include a base portion that is configured to retain the electrode in the rim of the first housing portion. The base portion can include an outer perimeter length that is greater than an inner perimeter length of the rim.
The electrode can be electrically connected to a wire of the medical probe. At least a portion of the wire can include an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity. The electrically conductive cover material can circumscribe the electrically conductive core material and an insulative jacket can circumscribe the electrically conductive cover material. At least a portion of the wire can include a plurality of strands and an insulative jacket circumscribing the plurality of the strands. Each strand of the plurality of strands respectively can include an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity. The electrically conductive cover material can circumscribe the electrically conductive core material.
The at least one spine of the medical probe can include nitinol, cobalt chromium, or other suitable material.
The plurality of electrodes can be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
The at least one spine can be configured to form an approximately spherically-shaped basket assembly or an approximately oblate-spheroid basket assembly when in the expanded form.
The medical probe can further include irrigation openings that can be configured to deliver an irrigation fluid to the plurality of electrodes.
The medical probe can further include an electrically insulative jacket each disposed between the at least one spine and a respective electrode of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines. Each of the electrically insulative jackets of the plurality of electrically insulative jackets can include a first lumen and a second lumen. The first lumen can be configured to receive a first wire and the second lumen can be configured to receive the respective spine. Furthermore, a cross-sectional shape of each electrically insulative jacket can include a substantially trapezoidal shape.
The disclosed technology can include a method of constructing a medical probe. The method can include aligning an electrode, a first insulated portion, and a second insulated portion. The method can include placing a spine of a basket catheter between the first insulated portion and the second insulated portion and interlocking the electrode, the first insulated portion, and the second insulated portion together to secure the electrode to the spine. The electrode, the first insulated portion, and the second insulated portion can be secured to the spine such that the first insulated portion and the second insulated portion electrically isolate the electrode from the spine and such that the electrode, the first insulated portion, and the second insulated portion are prevented from sliding proximally or distally along a length of the respective spine.
Interlocking the electrode, the first insulated portion, and the second insulated portion together can include interlocking a portion of at least one of the electrodes, the first insulated portion, and the second insulated portion through an aperture of a retainer ring of the spine. The method can include aligning the electrode, the first insulated portion, and the second insulated portion with the retainer ring.
Interlocking the electrode, the first insulated portion, and the second insulated portion together can include interlocking a protrusion of the electrode with the second insulated portion. The method can include forming a swage fitting on the protrusion to cause the electrode to interlock with the second insulated portion. Interlocking the electrode, the first insulated portion, and the second insulated portion together can include extending the protrusion through the retainer ring thereby preventing the electrode from sliding proximally or distally along the length of the spine.
The first insulated portion can include a first insulated washer and the second insulated portion can include a second insulated washer. The method can include positioning the first insulated washer and the second insulated washer so that the electrode is electrically isolated from the spine.
Interlocking the electrode, the first insulated portion, and the second insulated portion together can include extending a lip of the second insulated washer inwardly into the retainer ring thereby preventing the electrode from contacting the spine.
The first insulated portion can include a first insulated housing portion and the second insulated portion can include a second insulated housing portion. Interlocking the electrode, the first insulated portion, and the second insulated portion together can include interlocking the first insulated housing portion and the second insulated housing portion to thereby secure the electrode to the spine.
The second insulated housing portion can include a male connector and the first insulated housing portion can include a female connector that is configured receive the male connector and facilitate the first insulated housing portion to interlock with the second insulated housing portion.
The first insulated housing portion can include a rim that is configured to receive the electrode. Interlocking the electrode, the first insulated portion, and the second insulated portion together can include retaining a base portion of the electrode in the rim. The base portion can include an outer perimeter length that is greater than an inner perimeter length of the rim.
The method can include electrically connecting the electrode to a wire of the medical probe. At least a portion of the wire can include an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity. The electrically conductive cover material can circumscribe the electrically conductive core material and an insulative jacket can circumscribe the electrically conductive cover material. At least a portion of the wire can include a plurality of strands and an insulative jacket circumscribing the plurality of the strands. Each strand of the plurality of strands respectively can include an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity. The electrically conductive cover material can circumscribe the electrically conductive core material.
Each spine of the plurality of spines of the medical probe can include nitinol, cobalt chromium, or other suitable material.
The plurality of electrodes can be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
The plurality of spines can be configured to form an approximately spherically-shaped basket assembly or an approximately oblate-spheroid basket assembly when in the expanded form.
The medical probe can further include irrigation openings that can be configured to deliver an irrigation fluid to the plurality of electrodes.
The medical probe can further include a plurality of electrically insulative jackets each disposed between a respective spine of the plurality of spines and a respective electrode of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines. Each of the electrically insulative jackets of the plurality of electrically insulative jackets can include a first lumen and a second lumen. The first lumen can be configured to receive a first wire and the second lumen can be configured to receive the respective spine. Furthermore, a cross-sectional shape of each electrically insulative jacket can include a substantially trapezoidal shape.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 110%. In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment. As well, the term “proximal” indicates a location closer to the operator or physician whereas “distal” indicates a location further away to the operator or physician.
As discussed herein, vasculature of a “patient,” “host,” “user,” and “subject” can be vasculature of a human or any animal. It should be appreciated that an animal can be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like). It should be appreciated that the subject can be any applicable human patient, for example.
As discussed herein, “operator” can include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.
As discussed herein, the term “ablate” or “ablation”, as it relates to the devices and corresponding systems of this disclosure, refers to components and structural features configured to reduce or prevent the generation of erratic cardiac signals in the cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), referred throughout this disclosure interchangeably as pulsed electric field (PEF) and pulsed field ablation (PFA). Ablating or ablation as it relates to the devices and corresponding systems of this disclosure is used throughout this disclosure in reference 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 “ablate” or “ablation” also includes known methods, devices, and systems to achieve various forms of bodily tissue ablation as understood by a person skilled in the relevant art.
As discussed herein, the terms “bipolar” and “unipolar” when used to refer to ablation schemes describe ablation schemes which differ with respect to electrical current path and electric field distribution. “Bipolar” refers to ablation scheme utilizing a current path between two electrodes that are both positioned at a treatment site; current density and electric flux density is typically approximately equal at each of the two electrodes. “Unipolar” refers to ablation scheme utilizing a current path between two electrodes where one electrode having a high current density and high electric flux density is positioned at a treatment site, and a second electrode having comparatively lower current density and lower electric flux density is positioned remotely from the treatment site.
As discussed herein, the terms “biphasic pulse” and “monophasic pulse” refer to respective electrical signals. “Biphasic pulse” refers to an electrical signal having a positive-voltage phase pulse (referred to herein as “positive phase”) and a negative-voltage phase pulse (referred to herein as “negative phase”). “Monophasic pulse” refers to an electrical signal having only a positive or only a negative phase. Preferably, a system providing the biphasic pulse is configured to prevent application of a direct current voltage (DC) to a patient. For instance, the average voltage of the biphasic pulse can be zero volts with respect to ground or other common reference voltage. Additionally, or alternatively, the system can include a capacitor or other protective component. Where voltage amplitude of the biphasic and/or monophasic pulse is described herein, it is understood that the expressed voltage amplitude is an absolute value of the approximate peak amplitude of each of the positive-voltage phase and/or the negative-voltage phase. Each phase of the biphasic and monophasic pulse preferably has a square shape having an essentially constant voltage amplitude during a majority of the phase duration. 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 the phase of the biphasic pulse.
As discussed herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structures are generally illustrated as a substantially right cylindrical structure. However, the tubular structures may have a tapered or curved outer surface without departing from the scope of the present disclosure.
The term “temperature rating”, as used herein, is defined as the maximum continuous temperature that a component can withstand during its lifetime without causing thermal damage, such as melting or thermal degradation (e.g., charring and crumbling) of the component.
The present disclosure is related to systems, method or uses and devices which utilize end effectors having electrodes affixed to spines. Example systems, methods, and devices of the present disclosure may be particularly suited for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablative energies are typically provided to cardiac tissue by a tip portion of a catheter which can deliver ablative energy alongside the tissue to be ablated. Some example catheters include three-dimensional structures at the tip portion and are configured to administer ablative energy from various electrodes positioned on the three-dimensional structures. Ablative procedures incorporating such example catheters can be visualized using fluoroscopy.
Ablation of cardiac tissue using application of a thermal technique, such as radio frequency (RF) energy and cryoablation, to correct a malfunctioning heart is a well-known procedure. Typically, to successfully ablate using a thermal technique, cardiac electropotentials need to be measured at various locations of the myocardium. In addition, temperature measurements during ablation provide data enabling the efficacy of the ablation. Typically, for an ablation procedure using a thermal technique, the electropotentials and the temperatures are measured before, during, and after the actual ablation.
RF approaches can have risks that can lead to tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some thermal risks associated with RF ablation. However maneuvering cryoablation devices and selectively applying cryoablation is generally more challenging compared to RF ablation; therefore cryoablation is not viable in certain anatomical geometries which may be reached by electrical ablation devices.
IRE as discussed in this disclosure is a non-thermal cell death technology that can be used for ablation of atrial arrhythmias. To ablate using IRE/PEF, biphasic voltage pulses are applied to disrupt cellular structures of myocardium. The biphasic pulses are non-sinusoidal and can be tuned to target cells based on electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to produce heat at the treatment area, indiscriminately heating all cells in the treatment area. IRE therefore has the capability to spare adjacent heat sensitive structures or tissues which would be of benefit in the reduction of possible complications known with ablation or isolation modalities. Additionally, or alternatively, monophasic pulses can be utilized.
Electroporation can be induced by applying a pulsed electric field across biological cells to cause reversable (temporary) or irreversible (permanent) creation of pores in the cell membrane. The cells have a transmembrane electrostatic potential that is increased above a resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, the electroporation is reversable, meaning the pores can close when the applied pulse electric field is removed, and the cells can self-repair and survive. If the transmembrane electrostatic potential increases beyond the threshold potential, the electroporation is irreversible, and the cells become permanently permeable. As a result, the cells die due to a loss of homeostasis and typically die by apoptosis. Generally, cells of differing types have differing threshold potential. For instance, heart cells have a threshold potential of approximately 500 V/cm, whereas for bone it is 3000 V/cm. These differences in threshold potential allow IRE to selectively target tissue based on threshold potential.
The solution of this disclosure includes systems and methods for applying electrical signals from catheter electrodes positioned in the vicinity of myocardial tissue, preferably by applying a pulsed electric field effective to induce electroporation in the myocardial tissue. The systems and methods can be effective to ablate targeted tissue by inducing irreversible electroporation. In some examples, the systems and methods can be effective to induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied with the electrodes is below the electric field threshold of the target tissue allowing cells to repair. Reversible electroporation does not kill the cells but allows a physician to see the effect of reversible electroporation on electrical activation signals in the vicinity of the target location. Example systems and methods for reversible electroporation is disclosed in U.S. Pat. Publication 2021/0162210, the entirety of which is incorporated by reference in its entirety into this application as if set forth in full and attached in the appendix to priority application U.S. 63/301,146.
The pulsed electric field, and its effectiveness to induce reversible and/or irreversible electroporation, can be affected by physical parameters of the system and biphasic pulse parameters of the electrical signal. Physical parameters can include electrode contact area, electrode spacing, electrode geometry, etc. examples presented herein generally include physical parameters adapted to effectively induce reversible and/or irreversible electroporation. Biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, inter-pulse delay, total application time, delivered energy, etc. In some examples, parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various systems and methods of ablation including IRE are presented in U.S. Pat. Publications 2021/0169550A1, 2021/0169567A1, 2021/0169568A1, 2021/0161592A1, 2021/0196372A1, 2021/0177503A1, and 2021/0186604A1, the entireties of each of which are incorporated by reference into this application as if set forth in full and attached in the appendix to priority application U.S. 63/301,146.
To deliver pulsed field ablation (PFA) in an IRE (irreversible electroporation) procedure, electrodes should contact the tissue being ablated with a sufficiently large surface area. As described hereinbelow, the medical probe includes a flexible insertion tube having proximal and distal ends, and a basket assembly at the distal end of the flexible insertion tube. The basket assembly includes at least one spine and a plurality of electrode assemblies. Each electrode assembly can be configured to interlock with the spine to prevent the spine from sliding proximally or distally along the length of the spine.
Medical probe 22 includes a flexible insertion tube 30 and a handle 32 coupled to a proximal end of the insertion tube. During a medical procedure, a medical professional 34 can insert probe 22 through the vascular system of patient 28 so that a distal end 36 of the medical probe enters a body cavity such as a chamber of heart 26. Upon distal end 36 entering the chamber of heart 26, medical professional 34 can deploy a basket assembly 38 affixed to distal end 36. Basket assembly 38 can include a plurality of electrodes 40 affixed to a plurality of spines, as described in the description referencing
In the configuration shown in
As described hereinabove, in conjunction with tracking module 48, processor 46 may determine location coordinates of distal end 36 inside heart 26 based on impedances and/or currents measured between adhesive skin patches 44 and electrodes 40. Such a determination is typically after a calibration process relating the impedances or currents to known locations of the distal end has been performed. While embodiments presented herein describe electrodes 40 that are preferably configured to deliver IRE ablation energy to tissue in heart 26, configuring electrodes 40 to deliver any other type of ablation energy to tissue in any body cavity is considered to be within the spirit and scope of the present invention. Furthermore, although described in the context of being electrodes 40 that are configured to deliver IRE ablation energy to tissue in the heart 26, one skilled in the art will appreciate that the disclosed technology can be applicable to electrodes used for mapping and/or determining various characteristics of an organ or other part of the patient’s 28 body.
Processor 46 may include real-time noise reduction circuitry 50 typically configured as a field programmable gate array (FPGA), followed by an analog-to-digital (A/D) signal conversion integrated circuit 52. The processor can be programmed to perform one or more algorithms and uses circuitry 50 and circuit 52 as well as features of modules to enable the medical professional 34 to perform the IRE ablation procedure.
Control console 24 also includes an input/output (I/O) communications interface 54 that enables control console 24 to transfer signals from, and/or transfer signals to electrodes 40 and adhesive skin patches 44. In the configuration shown in
IRE ablation module 56 is configured to generate IRE pulses having peak power in the range of tens of kilowatts. In some examples, the electrodes 40 are configured to deliver electrical pulses having a peak voltage of at least 900 volts (V) and in some instances 1100V or higher. The medical system 20 performs IRE ablation by delivering IRE pulses to electrodes 40. Preferably, the medical system 20 delivers biphasic pulses between electrodes 40 on the spine. Additionally, or alternatively, the medical system 20 delivers monophasic pulses between at least one of the electrodes 40 and a skin patch.
Where irrigation is desired, system 20 supplies irrigation fluid (e.g., a saline solution) to distal end 36 and to the electrodes 40 via a channel (not shown) in insertion tube 30. Control console 24 includes an irrigation module 60 to monitor and control irrigation parameters, such as the pressure and the temperature of the irrigation fluid.
Based on signals received from electrodes 40 and/or adhesive skin patches 44, processor 46 can generate an electroanatomical map 62 that shows the location of distal end 36 in the patient’s body. During the procedure, processor 46 can present map 62 to medical professional 34 on a display 64, and store data representing the electroanatomical map in a memory 66. Memory 66 may include any suitable volatile and/or non-volatile memory, such as random-access memory or a hard disk drive.
In some embodiments, medical professional 34 can manipulate map 62 using one or more input devices 68. In alternative embodiments, display 64 may include a touchscreen that can be configured to accept inputs from medical professional 34, in addition to presenting map 62.
As shown in
In embodiments described herein, electrodes 40 can be configured to deliver ablation energy (RF and/or IRE) to tissue in heart 26. Additionally, or alternatively, the electrodes can also be used to determine the location of basket assembly 38 and/or to measure a physiological property such as local surface electrical potentials at respective locations on tissue in heart 26. The electrodes 40 can be biased such that a greater portion of the electrode 40 faces outwardly from the basket assembly 39 such that the electrodes 40 deliver a greater amount of electrical energy outwardly away from the basket assembly 38 (i.e., toward the heart 26 tissue) than inwardly toward the basket assembly 38.
Examples of materials ideally suited for forming electrodes 40 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity which allows the minimal heat generated on the tissue (i.e., by the ablation energy delivered to the tissue) to be conducted through the electrodes to the back side of the electrodes (i.e., the portions of the electrodes on the inner sides of the spines), and then to the blood pool in heart 26.
Basket assembly 38 has a distal end 94 and includes a stem 96 that extends longitudinally from a distal end 36 of tubular shaft 84 towards distal end 94 of basket assembly 38. As described supra, control console 24 includes irrigation module 60 that delivers irrigation fluid to distal end 36. Stem 96 includes multiple irrigation openings 98, wherein each given irrigation opening 98 can be angled to spray or otherwise disperse of the irrigation fluid to either a given electrode 40 or to tissue in heart 26.
Since electrodes 40 do not include irrigation openings that deliver irrigation fluid, the configuration described hereinabove enables heat to be transferred from the tissue (i.e., during an ablation procedure) to the portion of the electrodes on the inner side of the spines 214, and the electrodes 40 can be cooled by aiming the irrigation fluid, via irrigation openings 98, at the portion of the electrodes 40 on the inner side of the spines 214.
The spines 214 can be folded or otherwise bent such that a proximal end 216 of the spines 214 can be inserted into the distal end 85 of the tubular shaft 84 as shown in
As will be appreciated by one skilled in the art with the benefit of this disclosure, the basket assembly 38 shown in
Turning now to
The electrode assemblies 300, 800 are preferably asymmetrical with respect to a plane of the spine such that the electrode 340 presents an electrically conductive surface area facing outwardly from a periphery of the basket of the catheter and an insulating surface faces inwardly from the periphery of the basket. Furthermore, as will be appreciated by one of skill in the art, the electrodes 340, 840 can be the same as, or in place of, the electrode 40 previously described herein. That is, the electrode assemblies 300, 800 are examples of the present disclosure that can be used to attach the electrodes 340, 840 to the spine 214 to facilitate the electrodes 340, 840 performing the same or a similar function as the electrodes 40 described herein (e.g., delivering IRE ablation energy to cardiac tissue). One of skill in the art will appreciate that the electrode assemblies 300, 800 described herein are offered for illustrative purposes and that other electrode assemblies having similar features can reasonably be construed as falling within the scope of this disclosure. Thus, the present disclosure should not be construed as limited to the particular electrode assemblies 300, 800 shown in
The electrode 340, the first washer 350, and the second washer 360 can be configured to interlock with each other to form the electrode assembly 300. Furthermore, as will be described in greater detail herein, the electrode 340, the first washer 350, and the second washer 360 can be configured to interlock with a spine 214 to prevent the electrode assembly 300 from sliding proximally or distally along the length of the spine 214. To help prevent the electrode assembly 300 from sliding proximally or distally along the length of the spine 214, the spine 214 can include a retainer ring 330 that can be a ring formed in the spine 214 comprising an aperture 332 through which portions of the electrode assembly 300 can pass. The retainer ring 330 may be better observed in, and is described in relation to,
The electrode assembly 300 can be secured in place by including a mechanical interference that can prevent the electrode assembly 300 from separating once secured together. For example, the electrode 340 and at least the second washer 360 can be configured to form an interference fit together when pressed together to prevent the electrode 340 from becoming disengaged with the second washer 360. For example, an outer diameter of a protrusion of 342 of the electrode 340 can be slightly larger than the inner diameter of an aperture 362 through the second washer 360 to form an interference fit between the electrode 340 and the second washer 360 when pressed together.
As another example, the electrode 340 can include a swage fitting 344 that can be sized to secure the electrode assembly 300 in place once the electrode 340 is engaged with the second washer 360. The swage fitting 344 can be formed as the electrode 340 is pushed together with the second washer 360 with use of a tool adapted to form a swage fitting. Alternatively, or in addition, the swage fitting 344 can be formed prior to pressing the electrode 340 and the second washer 360 together. For example, the swage fitting 344, the second washer 360, or both, can comprise a resilient material that can deflect as the swage fitting 344 is pushed through an aperture 362 of the second washer 360. The swage fitting 344 can then return (or nearly) to its original configuration after being pushed through the aperture 362 of the second washer 360 such that the electrode assembly 300 is secured in place. In other words, the swage fitting 344 and the aperture 362 of the second washer 360 can both be configured to allow a portion of the electrode 340 to pass through the aperture 362 of the second washer 360 in a first direction but prevent the electrode 340 from passing through the aperture 362 in a second direction and becoming disengaged with the second washer 360 after assembly. As will be appreciated by one of skill in the art, although the electrode assembly 300 is illustrated as having a second washer 360 having an aperture 362 configured to receive at least a portion of an electrode 340 to secure the electrode assembly 300 in place, the disclosed technology is not so limited. As a non-limiting example, the configuration of the electrode assembly 300 may be switched and the electrode 340 may comprise an aperture (or multiple apertures) configured to receive a protrusion of the second washer 360 to secure electrode assembly 300 in place.
As shown in
Although the electrode assembly 300 and its components are illustrated in
Turning now to
The electrode assembly 800 can include a channel 890 through which at least a portion of the spine 214 can pass. For example, the channel 890 can be sized to at least partially receive the spine 214 such that the electrode assembly 800 can be secured to the spine 214 by clamping around the spine 214. For example, although not shown in
The first insulated housing portion 870 can further include a female connector 878 that is sized to receive a corresponding male connector 888 of the second insulated housing portion 880 (as shown and described in relation to
The channel portion 884 can include a rounded lip 886 that can be positioned proximate an outer edge of the channel portion 884 to help reduce stress concentrations and reduce the likelihood that the second insulated housing portion 880 damages the spine 214. The rounded lip 886 can include a rounded edge and be a generally concave shape such that the rounded lip 886 can permit the spine 214 to bend when transitioned between an expanded form and a collapsed form.
The second insulated housing portion 880 can include a wire aperture 882 that can be configured to receive a wire of the electrode assembly 800. For example, the wire can be disposed along the spine 214 and then pass through the wire aperture 882 and be electrically connected to the electrode 840. The wire can be welding, soldered, crimped, or otherwise connected to the electrode 840. The wire aperture 882 can include rounded edges to help reduce stress concentrations and reduce the likelihood that the second insulated housing portion 880 damages the wire. Alternatively, or in addition, the wire aperture 882 can be used for electrode 840 alignment. For example, the electrode 840 may have a pin-like emboss that would insert through an aperture included in the first insulated housing portion 870 and second insulated housing portion 880.
Although described as the first insulated housing portion 870 having the female connector 878 and the second insulated housing portion 880 having the male connector 888, one of skill in the art will appreciate that the two can be switched. In other words, the first insulated housing portion 870 can have the male connector 888 while the second insulated housing portion 880 can have a female connector 878 without departing from the scope of this disclosure. Furthermore, the electrode assembly 800 can have any number of female connectors 878 and male connectors 888 as would be suitable for the particular application.
Although the electrode assembly 800 and its components are illustrated in
As illustrated in
By including spines 214 configured to form various shapes when in the expanded form, the basket assembly 38 can be configured to position the various electrodes 40 attached to the spines 214 at various locations, with each location being nearer or farther from the distal end of the flexible insertion tube 30. For example, an electrode 40 attached to the spine 214 illustrated in
The insulative jacket 1306 can be configured to have a temperature rating between 150 and 200 degrees Centigrade so that the electrically insulative jacket 1306 melts or degrades (e.g., chars and crumbles) during soldering of the wire 1300 to the electrodes 40 (e.g., at a temperature of 300 degrees Centigrade) and therefore the insulative jacket 1306 of the wire 1300 does not need to be mechanically stripped. In other examples, the insulative jacket 1306 can have a temperature rating greater than 200 degrees Centigrade to prevent the electrically insulating material 1302 melting or degrading (e.g., charring and crumbling) during manufacture of the medical probe 22 and/or during use. The insulative jacket 1306 can be mechanically stripped from the wire 1300 prior to the wires 1300 being electrically connected to the electrodes 40.
The method 1400 can further include placing 1404 the spine 214 between the first insulated portion and the second insulated portion. For example, as described herein, the spine 214 can be positioned between the first washer 350 and the second washer 360. As another example, as described herein, the spine 214 can be placed between the first insulated housing portion 870 and the second insulated housing portion 880 with the electrode 840 being disposed between the spine 214 and the first insulated housing portion 870.
The method 1400 can further include interlocking 1406 the electrode 340, 840, the first insulated portion (i.e., the first washer 350 or the first insulated housing portion 870), and the second insulated portion (i.e., the second washer 360 or the second insulated housing portion 880) together until the electrode is secured to the spine 214. For example, the method 1400 can include interlocking the electrode 340, the first washer 350, and the second washer 360 together until the electrode assembly 300 is secured in place by the swage fitting 344 engaging with the second washer 360. As another example, the method 1400 can include pushing the first insulated housing portion 870 together with the second insulated housing portion 880 until the male connectors 888 engages with the female connector 878 and the electrode assembly 800 is secured to the spine 214.
As will be appreciated by one skilled in the art, the method 1400 can include any of the various features of the disclosed technology described herein and can be varied depending on the particular configuration. Thus, the method 1400 should not be construed as limited to the particular steps and order of steps explicitly described herein.
The disclosed technology described herein can be further understood according to the following clauses:
Clause 1: A medical probe, comprising: a tubular shaft having a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: at least one spine extending along the longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form; and a plurality of electrode assemblies, each electrode assembly of the plurality of electrode assemblies being attached to the at least one spine and comprising: an electrode; a first electrically insulating portion electrically isolating the electrode from the at least one spine; and a second electrically insulating portion electrically isolating the electrode from the at least one spine, the electrode, the first electrically insulating portion, and the second electrically insulating portion being interlocked onto the at least one spine such that the plurality of electrode assemblies are prevented from sliding proximally or distally along a length of the at least one spine.
Clause 2: The medical probe according to Clause 1, wherein the at least one spine comprises a retainer ring onto which a respective electrode assembly of the plurality of electrode assemblies is interlocked.
Clause 3: The medical probe according to Clause 1 or Clause 2, wherein the electrode comprises a protrusion configured to interlock with the second electrically insulating portion.
Clause 4: The medical probe according to Clause 3, wherein the protrusion is extending through the retainer ring, thereby preventing the electrode assembly from sliding along the length of the at least one spine.
Clause 5: The medical probe according to Clause 4, wherein the protrusion further comprises a swage fitting.
Clause 6: The medical probe according to any of Clauses 1-4, wherein: the first electrically insulating portion comprises a first washer; and the second electrically insulating portion comprises a second washer.
Clause 7: The medical probe according to Clause 6, wherein the first washer and the second washer are configured to prevent the electrode from contacting the at least one spine and to electrically isolate the electrode from the at least one spine.
Clause 8: The medical probe according to Clause 7, wherein the second washer comprises a lip configured to extend inwardly into the retainer ring to prevent the electrode from contacting the at least one spine.
Clause 9: The medical probe according to Clause 1, wherein: the first electrically insulating portion comprises a first housing portion; and the second electrically insulating portion comprises a second housing portion.
Clause 10: The medical probe according to Clause 9, wherein the first housing portion and the second housing portion are configured to interlock to secure the electrode to the at least one spine.
Clause 11: The medical probe according to Clause 10, wherein: the second housing portion comprises a male connector; and the first housing portion comprises a female connector configured receive the male connector and facilitate the first housing portion to interlock with the second housing portion.
Clause 12: The medical probe according to any of Clauses 9-11, the first housing portion comprising a rim configured to receive the electrode.
Clause 13: The medical probe according to Clause 12, the electrode further comprising a base portion configured to retain the electrode in the rim of the first housing portion.
Clause 14: The medical probe according to Clause 13, wherein the base portion comprises an outer perimeter length that is greater than an inner perimeter length of the rim.
Clause 15: The medical probe according to any of Clauses 1-14, wherein the electrode is electrically connected to a wire of the medical probe.
Clause 16: The medical probe according to Clause 15, wherein at least a portion of the wire comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material.
Clause 17: The medical probe according to any of Clauses 15 or 16, wherein at least a portion of the wire comprises a plurality of strands and an insulative jacket circumscribing the plurality of the strands, and wherein each strand of the plurality of strands respectively comprises an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material.
Clause 18: The medical probe according to any of Clauses 1-17, wherein the at least one spine comprises nitinol.
Clause 19: The medical probe according to any of Clauses 1-18, wherein the at least one spine comprises cobalt chromium.
Clause 20: The medical probe according to any of Clauses 1-19, wherein the plurality of electrodes is configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
Clause 21: The medical probe according to any of Clauses 1-20, wherein the at least one spine is configured to form an approximately spherically-shaped basket assembly.
Clause 22: The medical probe according to any of Clauses 1-20, wherein the at least one spine is configured form an approximately oblate-spheroid basket assembly.
Clause 23: The medical probe according to any of Clause 1-22, wherein the at least one spine further comprises an electrically insulative jacket, the electrically insulative jacket comprising a first lumen and a second lumen, the first lumen configured to receive a first wire and the second lumen configured to receive a second wire.
Clause 24: The medical probe according to any of Clause 23, wherein a cross-sectional shape of the electrically insulative jacket comprises a substantially trapezoidal shape.
Clause 25: The medical probe according to any of Clauses 1-24, further comprising irrigation openings configured to deliver an irrigation fluid to the plurality of electrodes.
Clause 26: A method of constructing a medical probe, the method comprising: aligning an electrode, a first insulated portion, and a second insulated portion; placing a spine of a basket catheter between the first insulated portion and the second insulated portion; and interlocking the electrode, the first insulated portion, and the second insulated portion together to secure the electrode to the spine such that the first insulated portion and the second insulated portion electrically isolate the electrode from the spine and such that the electrode, the first insulated portion, and the second insulated portion are prevented from sliding proximally or distally along a length of the spine.
Clause 27: The method according to Clause 26, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises interlocking a portion of at least one of the electrode, the first insulated portion, and the second insulated portion through an aperture of a retainer ring of the spine.
Clause 28: The method according to Clause 27, further comprising aligning the electrode, the first insulated portion, and the second insulated portion with the retainer ring.
Clause 29: The method according to Clause 28, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises interlocking a protrusion of the electrode with the second insulated portion.
Clause 30: The method according to Clause 29, further comprising forming a swage fitting on the protrusion to cause the electrode to interlock with the second insulated portion.
Clause 31: The method according to Clause 29, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises extending the protrusion through the retainer ring thereby preventing the electrode from sliding proximally or distally along the length of the spine.
Clause 32: The method according to any of Clauses 26-31, wherein: the first insulated portion comprises a first insulated washer; and the second insulated portion comprises a second insulated washer.
Clause 33: The method according to Clause 32, further comprising:
positioning the first insulated washer and the second insulated washer so that the electrode is electrically isolated from the spine.
Clause 34: The method according to Clause 32, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises extending a lip of the second insulated washer inwardly into the retainer ring thereby preventing the electrode from contacting the spine.
Clause 35: The method according to Clause 26, wherein: the first insulated portion comprises a first insulated housing portion; and the second insulated portion comprises a second insulated housing portion.
Clause 36: The method according to Clause 35, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises interlocking the first insulated housing portion and the second insulated housing portion to thereby secure the electrode to the spine.
Clause 37: The method according to Clause 36, wherein: the second insulated housing portion comprises a male connector; and the first insulated housing portion comprises a female connector configured receive the male connector and facilitate the first insulated housing portion to interlock with the second insulated housing portion.
Clause 38: The method according to any of Clauses 35-37, the first insulated housing portion comprising a rim configured to receive the electrode.
Clause 39: The method according to Clause 38, wherein interlocking the electrode, the first insulated portion, and the second insulated portion together comprises retaining a base portion of the electrode in the rim.
Clause 40: The method according to Clause 39, wherein the base portion comprises an outer perimeter length that is greater than an inner perimeter length of the rim.
Clause 41:The method according to any of Clauses 26-40, further comprising electrically connecting the electrode to a wire of the medical probe.
Clause 42: The method according to Clause 41, wherein at least a portion of the wire comprises an electrically conductive core material comprising a first electrical conductivity, an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material, and an insulative jacket circumscribing the electrically conductive cover material.
Clause 43: The method according to Clauses 41 or 42, wherein at least a portion of the wire comprises a plurality of strands and an insulative jacket circumscribing the plurality of the strands, and wherein each strand of the plurality of strands respectively comprises an electrically conductive core material comprising a first electrical conductivity and an electrically conductive cover material comprising a second electrical conductivity less than the first electrical conductivity, the electrically conductive cover material circumscribing the electrically conductive core material.
Clause 44: The method according to any of Clauses 26-43, wherein the spine comprises nitinol.
Clause 45: The method according to any of Clauses 26-43, wherein the spine comprises cobalt chromium.
Clause 46: The method according to any of Clauses 26-45, wherein the electrode is configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).
Clause 47: The method according to any of Clauses 26-46, wherein the spine is configured to form an approximately spherically-shaped basket assembly.
Clause 48: The method according to any of Clauses 26-46, wherein the spine is configured form an approximately oblate-spheroid basket assembly.
Clause 49: The method according to any of Clause 26-48, wherein the spine further comprises an electrically insulative jacket, the electrically insulative jacket comprising a first lumen and a second lumen, the first lumen configured to receive a first wire and the second lumen configured to receive a second wire.
Clause 50: The method according to any of Clause 49, wherein the electrically insulative jacket comprises a substantially trapezoidal shape.
Clause 51: The method according to any of Clauses 26-50, further comprising configuring irrigation openings to deliver an irrigation fluid to the electrode.
The embodiments described above are cited by way of example, and the present invention is not limited by what has been particularly shown and described hereinabove. Rather, the scope of the invention includes both combinations and sub combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
This application claims the benefit of priority under 35 U.S.C. § 119 to prior filed U.S. Provisional Pat. Application No. 63/301,146 filed on Jan. 20, 2022, the entire contents of which is hereby incorporated by reference as if set forth in full herein.
| Number | Date | Country | |
|---|---|---|---|
| 63301146 | Jan 2022 | US |
