Dual ultrasound catheter
Patent Information
- Application Number
- CN202180087578.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-01-22
- Filing Date
- 2021-09-10
- Publication Date
- 2026-10-30
- Estimated Expiration
- 2041-09-10
AI Technical Summary
例如,一些已知的超声传输构件太小以至于不能充分地膨胀以对抗闭塞或将超声能量递送到闭塞
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Figure CN116710004B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 63 / 140,372, filed January 22, 2021, entitled “Dual Ultrasonic Probe and Methods of Use,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field
[0003] The embodiments described herein generally relate to devices used in conjunction with an ultrasonic transducer assembly, and more specifically, to an ultrasonic probe assembly configured to transfer ultrasonic energy from an ultrasonic energy source to body tissue. Background Technology
[0004] Known ultrasound energy delivery systems are used in many different medical applications, such as medical imaging, to destroy blockages and / or ablate body tissue. In known ultrasound energy delivery systems for tissue ablation, ultrasound energy is transferred from an ultrasound energy source via a transducer assembly (e.g., including an ultrasound horn) and then to a delivery member (such as a wire or other elongated member) to reach the distal head. The delivery member can be, for example, an ultrasound probe assembly. The ultrasound energy propagates as a periodic wave through the delivery member, causing the distal head to vibrate. This vibrational energy can be used to ablate or otherwise destroy body tissue, such as vascular blockages, kidney stones, etc. To effectively reach various sites for treating endovascular occlusions or areas within the urinary tract, such ultrasound delivery members often have a length of approximately 65 cm or longer.
[0005] Known ultrasound transmission components (e.g., probe assemblies) are constructed to be flexible enough to pass through various body cavities and strong enough to deliver ultrasound energy to a distal tip (e.g., to ablate blood vessels or urinary tract obstructions). More durable transmission components allow for greater energy delivery but may not be flexible or thin enough to advance through the vascular system to the desired treatment area. Thinner transmission components can be more flexible but less durable and more prone to breakage.
[0006] To strike a balance between strength and flexibility, some known ultrasound delivery devices have reduced size or lower rigidity, making them less suitable for treating occlusions (e.g., chronic total occlusion (CTO) within the vascular system). For example, some known ultrasound delivery devices are too small to expand sufficiently to counteract the occlusion or deliver ultrasound energy to it. Other known ultrasound delivery devices lack sufficient rigidity to penetrate the occlusion, thus limiting the effectiveness of ultrasound energy delivery. While some known systems include larger guiding catheters in which delivery devices can be placed, many known systems deliver energy via an internal delivery device to ablate the occlusion. Therefore, in many cases, the energy delivered from the internal delivery device is limited to a smaller portion of the occlusion.
[0007] While some known systems include multiple transport components through which energy (e.g., electrical energy) can be transferred to ablate body tissue, such known systems do not provide the ability to selectively transfer energy among multiple transport components. Furthermore, such known systems may require each transport component to be individually coupled to an energy source.
[0008] Therefore, there is a need for improved devices and methods for transferring ultrasound energy from an ultrasound energy source to body tissues. There is also a need for improved methods for ablating chronic total occlusions (CTOs) within the vascular system. Summary of the Invention
[0009] This document describes apparatus and methods for using an ultrasonic probe assembly in conjunction with an ultrasonic ablation system. In some embodiments, an apparatus includes a transducer assembly, a first probe, and a second probe. The transducer assembly includes a transducer housing and an ultrasonic transducer horn disposed within (or coupled to) the transducer housing. The transducer horn includes a probe coupler. The first probe includes a first coupler and a first elongated member coupled to the first coupler. The first coupler has a first coupling portion and a second coupling portion, and the first coupling portion is configured to be releasably coupled to the probe coupler of the transducer horn, such that the first probe is coupled to the ultrasonic transducer. The second probe includes a second coupler and a second elongated member coupled to the second coupler. The second coupler has a third coupling portion that is releasably coupled to the second coupling portion of the first coupler, such that the second probe is coupled to the ultrasonic transducer.
[0010] In some embodiments, a method includes introducing a distal portion of an ultrasound probe assembly into a patient's blood vessel. The ultrasound probe assembly may be coupled to an ultrasound transducer assembly and includes a first probe and a second probe. The first probe includes a first coupler and a first elongated member coupled to the first coupler, and is coupled to the transducer assembly via the first coupler. The second probe includes a second coupler and a second elongated member coupled to the second coupler and is releasably coupled to the first coupler such that the second probe is coupled to the ultrasound transducer assembly via the first probe. The distal portion of the ultrasound probe assembly is moved through an obstruction in the blood vessel, such that the distal portion of the first elongated member penetrates the obstruction and the distal portion of the second elongated member penetrates the obstruction. Ultrasonic energy is transferred from the ultrasound transducer assembly to the first and second probes, such that the ultrasonic energy is delivered to the obstruction through the first and second elongated members.
[0011] In some embodiments, a method includes introducing a distal portion of an ultrasound probe assembly into a patient's blood vessel. The ultrasound probe assembly may be coupled to an ultrasound transducer assembly and includes a first probe and a second probe. The first probe includes a first coupler and a first elongated member coupled to and via the first coupler to the ultrasound transducer assembly. The second probe includes a second coupler and a second elongated member coupled to the second coupler, and the second elongated member defines a lumen. The first elongated member is within the lumen of the second elongated member such that a first distal tip of the first elongated member extends through a second distal tip of the second elongated member and extends outside the lumen of the second elongated member. The second coupler is releasably coupled to the first coupler. The distal portion of the ultrasound probe assembly is moved through an obstruction in the blood vessel such that at least the distal tip of the first elongated member penetrates the obstruction. Ultrasonic energy is transferred from the ultrasound transducer assembly to at least the first probe such that the ultrasonic energy is delivered to the obstruction through at least the first elongated member. The first probe is removed from the second probe. A third probe is inserted into the lumen of the second probe. The third probe includes a third coupler and a third elongated member coupled to the third coupler. The third elongated member has a third distal tip, sized to restrict movement of the third distal tip through the second distal tip of the second elongated member. The second and third probes are positioned through the blockage in the blood vessel. After insertion of the third probe, a second coupler of the second probe is coupled to a third coupler of the third probe. This involves proximally moving the second elongated member relative to the third elongated member, such that the second distal tip engages the third distal tip and deforms the distal portion of the second elongated member to create a contact position between the third and second elongated members. Ultrasonic energy is transmitted from the ultrasonic transducer assembly to at least the third probe. At least a portion of the ultrasonic energy is delivered from the third elongated member through the contact position and the second elongated member to the blockage. Attached Figure Description
[0012] Figure 1 This is an illustration of a system for delivering ultrasonic energy to body tissues according to an embodiment.
[0013] Figure 2 Is included Figure 1 A cross-sectional view of the ultrasonic transducer in the system.
[0014] Figure 3A This is a perspective view of the ultrasonic probe assembly according to an embodiment.
[0015] Figure 3B yes Figure 3A A magnified view of detail C.
[0016] Figure 4A yes Figure 3A Side view of the ultrasound probe assembly.
[0017] Figure 4B It is along Figure 4A The side view of the cross section cut by line AA in the figure.
[0018] Figure 5 yes Figure 4B A magnified view of detail B.
[0019] Figure 6A yes Figure 3A A perspective view of the internal probes of the ultrasonic probe assembly.
[0020] Figure 6B yes Figure 3A A perspective view of the external probe of the ultrasonic probe assembly.
[0021] Figure 7A This is a schematic diagram of the internal and external probes of the ultrasonic probe assembly according to an embodiment.
[0022] Figure 7B This is a schematic diagram of the internal and external probes of an ultrasonic probe assembly according to another embodiment.
[0023] Figure 7C This is a schematic diagram of the internal and external probes of an ultrasonic probe assembly according to yet another embodiment.
[0024] Figure 8 This is a schematic side view of an ultrasound probe assembly according to an embodiment, shown inserted near an intravascular blockage.
[0025] Figure 9A It is a side view of a blood vessel of a patient with a blockage, wherein the first and second ultrasound probe assemblies according to an embodiment are shown inserted into the blood vessel near the blockage and in a usage configuration to apply ultrasound energy to the blockage.
[0026] Figure 9B yes Figure 9A A side view of a blood vessel, wherein a third ultrasound probe assembly is shown inserted in a first configuration into the vicinity of a first ultrasound probe assembly.
[0027] Figure 9C yes Figure 9C The third ultrasound probe assembly and the side view of the blood vessel, which is in a second configuration near the blockage to apply ultrasound energy to the blockage.
[0028] Figure 10A This is a perspective view of an ultrasonic probe assembly according to another embodiment.
[0029] Figure 10B yes Figure 10A A magnified view of detail C.
[0030] Figure 11A yes Figure 10A Side view of the ultrasound probe assembly.
[0031] Figure 11B It is along Figure 11A The side view of the cross section cut by line AA in the figure.
[0032] Figure 12 yes Figure 10B A magnified view of detail B.
[0033] Figure 13A yes Figure 8 A perspective view of the internal probes of the ultrasonic probe assembly of A.
[0034] Figure 13B yes Figure 8 A perspective view of the external probe of the ultrasound probe assembly of A.
[0035] Figure 14 This is a side view of an ultrasonic probe assembly according to another embodiment.
[0036] Figure 15A yes Figure 14 Side view of the internal probe of the ultrasound probe assembly.
[0037] Figure 15B yes Figure 14 Side view of the external probe of the ultrasound probe assembly.
[0038] Figure 16 yes Figure 14 A side view of the proximal portion of the probe assembly, wherein the outer probe is disconnected from the inner probe.
[0039] Figure 17A yes Figure 14 A side view of the proximal portion of the probe assembly, wherein the outer probe is connected to the inner probe.
[0040] Figure 17B yes Figure 14 A side view of the distal portion of the probe assembly.
[0041] Figure 18A yes Figure 14 A side view of the proximal portion of the external probe of the probe assembly.
[0042] Figure 18B yes Figure 14 A side view of the distal portion of the external probe of the probe assembly.
[0043] Figure 18C yes Figure 14 A proximal perspective view of the external probe of the probe assembly.
[0044] Figure 19 yes Figure 14 A side view of the proximal portion of the internal probe of the probe assembly.
[0045] Figure 20 This is a flowchart illustrating a method for transferring ultrasound energy to body tissues. Detailed Implementation
[0046] This article describes an apparatus and method for using an ultrasound ablation system with a transducer assembly and an ultrasound probe assembly that can be coupled thereto. The ultrasound ablation system can be used to transfer ultrasound energy from an ultrasound energy source to body tissue. For example, an ultrasound ablation system can be used to transfer ultrasound energy to blockages within a patient's blood vessels. Blood vessels can be, for example, veins, arteries, ureters, bile ducts, etc.
[0047] In some embodiments, the transducer assembly includes a transducer horn and a transducer. The ultrasonic probe assembly may include a first probe and a second probe, each of which may be coupled to the transducer assembly to selectively couple the first probe and the second probe to the transducer and / or the transducer horn. Thus, the first probe and the second probe may each receive ultrasonic energy from the same transducer. The transducer may, for example, include one or more piezoelectric transducer components. In some embodiments, the transducer may include a stack of transducers (and may be referred to as an ultrasonic stack). The first and second probes may be coupled together coaxially or non-coaxially, as described in more detail herein.
[0048] As used in this specification, the terms “proximal” and “distal” refer to the orientations of the device that are closer to and further away from the user who places the device in contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient’s body will be the distal end, while the other end of the device (e.g., the end of the device that is manipulated by the user) will be the proximal end of the device.
[0049] As used herein, the terms “approximately” and “approximately” generally mean a value plus or minus 10%. For example, approximately 0.5 would include 0.45 and 0.55, approximately 10 would include 9 to 11, and approximately 1000 would include 900 to 1100.
[0050] As used herein, the term "assembly" can refer to multiple features or a single feature having multiple parts. For example, when referring to an assembly of walls, an assembly of walls can be considered as a single wall having multiple parts, or an assembly of walls can be considered as multiple distinct walls. Thus, an article of integral construction can include an assembly of walls. Such an assembly of walls can include multiple parts that are, for example, continuous or discontinuous with each other. An assembly of walls can also be made from multiple articles produced separately and then joined together (e.g., via welding, adhesives, or any suitable method).
[0051] As used herein, the term "target tissue" refers to an internal or external tissue of a patient to which ultrasound energy ablation technology is applied. For example, target tissue can be cancer cells, tumor cells, lesions, vascular occlusion, thrombosis, stones, uterine fibroids, bone metastases, adenomyosis, or any other body tissue. Furthermore, the examples of target tissues presented are not an exhaustive list of suitable target tissues. Therefore, the ultrasound energy system described herein is not limited to the treatment of the tissues mentioned above and can be used on any suitable body tissue. Moreover, "target tissue" can also include artificial materials within or associated with the body, such as, for example, scaffolds, portions of artificial tubes, or fasteners within the body. Thus, for example, the ultrasound energy system described herein can be used on or within scaffolds or artificial bypass grafts.
[0052] As used herein, the term "stiffness" refers to an object's resistance to deflection, deformation, and / or displacement caused by an applied force, and is generally understood as the opposite of an object's "flexibility." For example, a pipe wall with greater stiffness resists deflection, deformation, and / or displacement more effectively when subjected to force than a pipe wall with lower stiffness. Similarly, a pipe with higher stiffness can be characterized as being more rigid than a pipe with lower stiffness. Stiffness can be characterized by the amount of force applied to an object and the distance by which a first part of the object deflects, deforms, and / or displaces relative to a second part of the object. When characterizing the stiffness of an object, the deflection distance can be measured as the deflection of a portion of the object that is different from the portion of the object to which the force is directly applied. In other words, in some objects, the point of deflection differs from the point where the force is applied.
[0053] Stiffness (and therefore flexibility) is a broad property of an object and thus depends on the materials that form the object and certain physical characteristics of the object (e.g., cross-sectional shape, length, boundary conditions, etc.). For example, the stiffness of an object can be increased or decreased by selectively including materials with desired elastic modulus, flexural modulus, and / or stiffness. The elastic modulus is a strength property (i.e., inherent) of a material and describes the tendency of an object to undergo elastic (i.e., non-permanent) deformation in response to an applied force. A material with a high elastic modulus will not deflect as much as a material with a low elastic modulus in the presence of equivalent applied stress. Therefore, the stiffness of an object can be reduced, for example, by introducing and / or constructing an object with a relatively low elastic modulus.
[0054] The stiffness of an object can also be increased or decreased by altering its physical characteristics, such as its shape or cross-sectional area. For example, an object with a greater length and cross-sectional area can be stiffer than an object with the same length but a smaller cross-sectional area. As another example, the stiffness of an object can be reduced by including one or more stress concentration lifting zones (or discontinuities) that cause deformation at lower stresses and / or at specific locations on the object. Therefore, the stiffness of an object can be reduced by decreasing and / or altering its shape.
[0055] The embodiments described herein relate to ultrasonic energy ablation systems. In such systems, an ultrasonic probe assembly can be operatively coupled to an ultrasonic energy source to deliver ultrasonic energy to target tissue. For example, Figure 1 This is an illustration of an ultrasonic energy ablation system 100 according to an embodiment. The ultrasonic energy ablation system 100 (also referred to herein as an "ultrasonic system" or "ultrasonic ablation system" or simply a "system") includes an ultrasonic generator 180 (also referred to herein as a "generator"), a foot switch 170, an ultrasonic transducer assembly 150, and an ultrasonic probe assembly 110 (also referred to herein as a "probe assembly"). The ultrasonic generator 180 can be any suitable generator configured to generate, control, amplify, and / or transmit electrical signals (e.g., voltages) to the transducer assembly 150.
[0056] The ultrasonic generator 180 includes at least a processor, a memory, and a circuit system. Figure 1(Not shown) to generate electronic signals (i.e., current and voltage) with desired characteristics that can be received by the ultrasonic transducer assembly 150 and converted into ultrasonic energy. In some embodiments, the ultrasonic generator 180 may be electrically coupled to (e.g., "inserted") an electrical outlet, such that the ultrasonic generator 180 receives a flow of current. For example, in some embodiments, the ultrasonic generator 180 may be inserted into a wall outlet, and the wall outlet delivers alternating current (AC) power at a given voltage (e.g., 120V, 230V, or other suitable voltage) and a given frequency (e.g., 60Hz, 50Hz, or other suitable frequency).
[0057] Although Figure 1 Not shown, but the ultrasonic generator 180 includes electronic circuitry, hardware, firmware, and / or instructions to cause the ultrasonic generator 180 to act as a frequency converter and / or boost converter. In this way, the ultrasonic generator 180 can generate and / or output a voltage with desired characteristics to the transducer assembly 150 to produce a desired ultrasonic energy output. For example, in some embodiments, the ultrasonic generator 180 can receive AC power with a frequency of approximately 60 Hz and a voltage of approximately 120 V, and convert the voltage to a frequency of approximately 20,000 Hz to 35,000 Hz and a voltage of approximately 500–1500 VAC (RMS). Therefore, the ultrasonic generator 180 can supply an AC power flow with an ultrasonic frequency to the transducer assembly 150.
[0058] like Figure 1 As shown, system 100 may optionally include a foot switch 170 electrically connected to ultrasound generator 180 via foot switch cable 171. Foot switch 170 includes a set of pedals 172 (e.g., two pedals as shown), operable to control the delivery of ultrasonic electrical energy to ultrasound transducer assembly 150. For example, in some embodiments, a user (e.g., a physician, technician, etc.) may engage and / or depress one or more of the pedals 172 to control the current supplied to ultrasound transducer assembly 150, such that probe assembly 110 then delivers the desired ultrasonic energy to body tissue, as described further in detail herein.
[0059] Transducer assembly 150 is electrically connected to ultrasonic generator 180 via transducer cable 167. In this way, transducer assembly 150 can receive electrical signals (i.e., voltage and current) from ultrasonic generator 180. Transducer assembly 150 is configured via an assembly of piezoelectric members 162 (i.e., piezoelectric rings) and transducer horn 163 (see, for example...). Figure 2 The transducer assembly 150 generates and amplifies the desired ultrasonic energy and transfers the ultrasonic energy to the probe assembly 110 and / or the transmission member 120. The transducer assembly 150 may be any suitable assembly of the type shown and described herein.
[0060] For example, in some embodiments, such as Figure 2 As shown, the transducer assembly 150 includes a housing 151 having a proximal portion 152 and a distal portion 153. The housing 151 is configured to house or otherwise enclose at least a portion of the flow tube 157, bolts 158, backplate 160, insulator assembly 161, piezoelectric ring assembly 162 (the assembly of insulators and piezoelectric rings may be referred to as an ultrasonic stack), and transducer horn 163.
[0061] The proximal portion 152 of housing 151 is coupled to a proximal cover 154 (e.g., via adhesive, press-fit or friction fit, threaded coupling, mechanical fastener, etc.). The proximal cover 154 defines an opening 155 such that it can receive a portion of connector 156 (e.g., a luer connector) on its proximal side (e.g., substantially outside housing 151) and a portion of flow tube 157 on its distal side (e.g., substantially inside housing 151). Further extending, the proximal cover 154 can receive both connector 156 and flow tube 157, forming a substantially fluid seal with both. In this way, a vacuum can be applied via connector 156 to flush and / or aspirate the area of the body in which probe assembly 110 is disposed. Similarly, this arrangement results in connector 156 being positioned in fluid communication with a lumen defined by transmission member 120. Although transducer assembly 150 is shown to include flow paths (and connector 156) to facilitate flushing and / or suction through transducer assembly 150, in other embodiments, the flow paths (one or more) for flushing and / or suction need not be within the transducer assembly, but may instead be located only in other parts of the system (e.g., within the probe assembly).
[0062] The distal portion 153 of housing 151 is configured to receive a transducer horn 163, such that the transducer horn 163 is coupled to an inner surface of housing 151. More specifically, the transducer horn 163 may be at least partially deployed within housing 151 such that the transducer horn 163 can move relative to housing 151 (e.g., when amplifying ultrasonic energy), but does not move out of housing 151 during normal use. The transducer horn 163 includes a proximal portion 164 and a distal portion 165, and defines a lumen 166 therethrough. The lumen 166 is configured to receive a portion of a bolt 158 at the proximal portion 164 of the transducer horn 163 and a portion of a probe assembly 120 at the distal portion 165 of the transducer horn 163, both of which are described in further detail herein.
[0063] like Figure 2As shown, a backplate 160, an insulator 161, and a piezoelectric element 162 are disposed within a housing 151 and surrounding a bolt 158. Therefore, the piezoelectric element 162 and the insulator 161 can be in the form of a ring. More specifically, the arrangement of the backplate 160, insulator 161, and piezoelectric element 162 is such that the backplate 160 is positioned close to the insulator 161 and the piezoelectric element 162. The piezoelectric elements 162 are each disposed between the insulators 161. Similarly, a first insulator 161 is disposed proximal to the piezoelectric element 162, and a second insulator 161 is disposed distal to the piezoelectric ring 162. The piezoelectric element 162 is electrically connected to the ultrasonic generator 180 (e.g., via...). Figure 1 and 2 (Wires not shown in the text), as described in further detail herein.
[0064] like Figure 2 As shown, a portion of bolt 158 is configured to be deployed within a cavity 166 defined by transducer horn 163. More specifically, a portion of bolt 158 forms a threaded engagement with the inner surface of transducer horn 163 defining cavity 166. In this way, bolt 158 can advance within cavity 166 such that bolt 158 applies compressive force to backplate 160, insulator 161, and piezoelectric member 162. Therefore, backplate 160, insulator 161, and piezoelectric member 162 are held between the head of bolt 158 (e.g., at the proximal end) and the proximal surface of transducer horn 163. The torque applied to bolt and / or the clamping force applied between the head of bolt 158 and the proximal surface of transducer horn 163 ensures that the deviation of the transducer's inherent frequency deviation is within ten percent of its nominal value. Therefore, in use, piezoelectric member 162 can vibrate and / or move transducer horn 163, as further described herein.
[0065] Bolt 158 also defines a lumen 159 such that the proximal portion of bolt 158 can receive the distal portion of flow tube 157. In this way, the lumen 159 defined by bolt 158 and flow tube 157 together provide fluid communication between the lumen 166 defined by transducer horn 163 and connector 156. Therefore, the lumen 166 of transducer horn 163 can be positioned to provide fluid communication with a volume substantially outside the proximal end of housing 151.
[0066] like Figure 1 and 2As shown, probe assembly 110 includes at least an elongated transmission member 120 (also referred to herein as a “transmission member” or “elongated member”) and a coupler 130. In some embodiments, probe assembly 110 may include a plurality of probes, each having an elongated member and a coupler. Such embodiments are described below. For example, in some embodiments, transducer assembly 150 may be used with (or coupled to) probe assembly 210. Coupler 130 includes a proximal portion 131 and a distal portion 132 and defines a lumen 133 extending therethrough. The proximal portion 131 of coupler 130 is deployed within a lumen 166 at the distal portion 165 of transducer horn 163 and forms a threaded engagement with a probe coupling 168 at the inner surface of the defined lumen 166 of transducer horn 163. In this embodiment, probe coupling 168 is a threaded coupling. The distal portion 131 of coupler 130 is configured to receive a portion of transmission member 120 to securely couple transmission member 120 to coupler 130. In this way, probe assembly 110 can be removably coupled to transducer assembly 150 via coupler 130.
[0067] The transport member 120 is an elongated tube having a proximal portion 121 and a distal portion 122. The transport member 120 can be of any suitable shape, size, or configuration, and is described in more detail herein with respect to specific embodiments. In some embodiments, the transport member 120 may optionally include any suitable feature configured to increase the flexibility (e.g., reduce stiffness) of at least a portion of the transport member 120, thereby facilitating the transport member 120 through tortuous lumens (e.g., urinary tract, vein, artery, etc.) within a patient's body. For example, in some embodiments, a portion of the transport member 120 may be formed of a material with lower stiffness, while different portions of the transport member 120 may be formed of a material with higher stiffness. In some embodiments, the stiffness of at least a portion of the transport member 120 can be reduced by defining openings (e.g., notches, grooves, channels, slits, etc.), thereby reducing the area moment of inertia of a portion of the transport member 120.
[0068] In use, a user (e.g., a surgeon, technician, physician, etc.) can operate the ultrasound system 100 to deliver ultrasound energy to target body tissues within a patient. For example, the ultrasound system 100 can be used to treat a patient's chronic total occlusion (CTO). For instance, a user can engage pedal 172 of foot switch 170, causing the ultrasound generator 180 to generate alternating current (AC) and voltage at a desired ultrasound frequency (e.g., 20,000 Hz). In this way, the ultrasound generator 180 can supply AC power to the piezoelectric ring 162. The AC power can cause the piezoelectric ring 162 to oscillate at a desired frequency (e.g., expand, contract, or otherwise deform), which in turn causes the transducer horn 163 to move relative to the housing 151. Thus, as the probe assembly 110 is coupled to the transducer horn 163, the movement of the transducer horn 163 vibrates and / or moves the probe assembly 110. In this manner, the distal portion 122 of the transmission member 120 can be deployed within the portion of the patient adjacent to the target tissue, such that the transmission member 120 transfers at least a portion of the ultrasound energy to the target tissue. Figure 1 and 2 (Not shown in the image). For example, in some embodiments, the distal tip of the transmission member 120 can impact target tissue, such as, for example, breaking up occlusions. In some embodiments, movement of the distal portion 122 of the transmission member 120 causes cavitation to occur within a portion of the patient. In this way, cavitation can also break up target tissue. In some embodiments, the ultrasound system 100 can optionally be used to aspirate and / or supply flushing to the target tissue site. For example, a portion of the probe assembly 110 may include a port coupled to a fluid line that can be used to supply flushing or aspirate particles from blockages at the treatment site.
[0069] Figure 3A-6B An ultrasonic probe assembly 210 is illustrated that can be used in an ultrasonic energy ablation system such as system 100 described above. For example, the ultrasonic probe assembly 210 can be releasably coupled to a transducer assembly 150. In this embodiment, the probe assembly 210 includes a first probe 235 (see, for example...). Figure 5 and 6A ) and a second probe 245 that can be releasably coupled to the first probe 235 (see, for example) Figure 5 and 6B As described in further detail below, the first probe 235 includes a first elongated transmission member 220 (also referred to herein as the "first transmission member" or "first elongated member" or "transmission member" or "elongated member") and a coupler 230. The coupler 230 includes a proximal portion 231 and a distal portion 232 and defines a central lumen 223 that extends at least partially through the coupler 230 (see, for example...). Figure 5Coupler 230 also defines a side lumen 224 in fluid communication with the central lumen 223. In some embodiments, a side port (e.g., similar to side port 425 described below) may be coupled to and / or within the side lumen 224 to provide aspiration and / or flushing through the first probe 235. For example, the side lumen may be coupled to and in fluid communication with a delivery line that can be used to supply flushing or aspirate particles from blockages at the treatment site. Embodiments of fluid lines are discussed below with respect to probe assembly 410. In other embodiments, coupler 230 may not need to include a side lumen, but may only include a central lumen passing through it to facilitate aspiration and / or flushing. The proximal portion 231 of coupler 230 includes a first coupling portion 234 configured to releasably couple to a probe coupler (see, for example, the distal portion 165 of transducer assembly 150) at the distal portion of the transducer assembly (e.g., the distal portion 165 of transducer assembly 150). Figure 2 The probe coupler 168 is used in the transducer assembly 150. For example, the first coupling portion 234 may be a threaded coupler that is threaded within the transducer assembly 150 to a mating threaded probe coupler 168 within a lumen 166 at the distal portion 165 of the transducer horn 163. In this way, the first probe 235 can be removably coupled to the transducer assembly 150 via the coupler 230. The coupler 230 also includes two flat, serrated surfaces 237, which can be used to receive tools to help secure the coupler 230 to the probe coupler. For example, a tool such as a medical wrench can be clamped onto the surfaces 237 and used to fasten the coupler 230 to the probe coupler.
[0070] The distal portion 232 of coupler 230 is configured to receive a portion of transmission member 220 to securely couple transmission member 220 to coupler 230 (i.e., within central lumen 223). Transmission member 220 includes a proximal portion 221 and a distal portion 222. Proximal portion 221 is securely coupled to distal portion 232 of coupler 230. Distal portion 222 is configured for insertion into a patient, as described in more detail below. As described above, first probe 235 also includes a second coupling portion 236 to releasably couple first probe 235 to second probe 245.
[0071] The second probe 245 includes an elongated transmission member 244 (also referred to herein as the "second transmission member," "second elongated member," "transmission member," or "elongated member") and a coupler 240. The coupler 240 includes a proximal portion 243 and a distal portion 247 and defines a lumen 239 extending at least partially through it (see, for example...). Figure 5The transmission member 244 includes a proximal portion 241 and a distal portion 242. The proximal portion 241 is fixedly coupled to the distal portion 247 of the coupler 240. The proximal portion 243 of the coupler 240 includes a coupling portion 246 (also referred to herein as a “third coupling portion”) configured to be releasably coupled to a second coupling portion 236 of the first probe 235. Thus, the second probe 245 can be removably or releasably coupled to the transducer assembly 150 via the first probe 235 (e.g., via the coupler 230). In this way, both the first probe 235 and the second probe 245 can be coupled to the same transducer assembly and driven by the same ultrasonic transducer. More specifically, the lumen 248 of the second probe 245 can receive at least a portion of the first elongated member 220 of the first probe 235, and the coupler 230 can be releasably coupled to the coupler 240. For example, the elongated member 220 of the first probe 235 can be inserted through the lumen 248 of the second elongated member 244, such that the distal end of the first elongated member 220 extends beyond the lumen 248. In this way, the second elongated member 244 can be used as a guiding catheter, as described below. By extending distally beyond the lumen 248, the distal portion 222 of the elongated member 220 can be advanced into the target tissue.
[0072] In this embodiment, the second coupling portion 236 is a quick-release connector (e.g., a Luer lock connector) and the third coupling portion 246 of the second probe 245 is a mating quick-release connector to provide a quick-release connection between the first probe 235 and the second probe 245. In an alternative embodiment, the second coupling portion 236 may be a threaded coupling element and the third coupling portion 246 may be a threaded coupling element to thread the first probe 235 to the second probe 245. Such embodiments are described below with reference to probe assemblies 310 and 410. In some embodiments, the second probe 245 may also include a tapered distal portion, which may be incorporated into the second elongated member 244 or provided as a separate component. This embodiment will be described below with reference to probe assembly 410 including a tapered distal portion 449 or an alternative second probe 245' including a tapered distal portion 249'. Figures 9A-9C The following discussion will be based on the diagram shown. In some embodiments, the tapered distal portion of the second probe 245 may be at an angle between 30 and 40 degrees relative to the centerline of the second elongated member 244. The tapered distal portion 249' of the second probe 245 can assist in inserting the probe assembly 210 into the tissue to be treated. Moreover, as shown in the reference... Figures 9A-9C The tapered distal portion 249' discussed can also facilitate desired deformation of the probe assembly to create enhanced contact between the first and second probes. This enhanced contact can lead to improved transmission of ultrasound energy from the first (internal) probe to the target tissue.
[0073] The first elongated member 220 and the second elongated member 244 may each have any suitable shape, size, or configuration as described herein. In some embodiments, the elongated members 220 and 244 may optionally include any suitable feature configured to increase the flexibility (e.g., reduce stiffness) of at least a portion of the transmission members 220, 244, thereby facilitating the passage of the elongated members 220, 244 through tortuous lumens (e.g., urinary tract, veins, arteries, etc.) within a patient's body. For example, in some embodiments, a portion of the elongated members 220 and / or 244 may be formed of a material with lower stiffness, while different portions of the elongated members 220, 244 may be formed of a material with higher stiffness. In some embodiments, the stiffness of at least a portion of the elongated members 220 and / or 244 can be reduced by defining one or more openings (e.g., notches, grooves, channels, cuts, etc.) in the elongated members 220 and / or 244 or by providing openings within a woven material formed as described below, thereby reducing the area moment of inertia of that portion of the transmission members 220, 244.
[0074] Additionally, the first elongated member 220 may be formed of the same or different material as the second elongated member 244. In some embodiments, the second elongated member 244 is formed of a more flexible material than the first elongated member 220. In other words, the first elongated member 220 is more rigid than the second elongated member 244. In some embodiments, the second elongated member 244 is formed of a braided metal material. In some embodiments, the braided material is stainless steel (e.g., 304 stainless steel), Nitinol® (i.e., nickel-titanium alloy), or other metal alloys with a density of, for example, 60-75 PPI (warp density per inch) and a diamond and / or spiral pattern.
[0075] As described above with reference to the preceding embodiments, in use, a user (e.g., a surgeon, technician, physician, etc.) can operate the ultrasound system 100 (as described above) to deliver ultrasound energy to target body tissues within a patient. For example, the ultrasound system 100 and probe assembly 210 can be used to treat a patient's chronic total occlusion (CTO).
[0076] The probe assembly 210, having two ultrasound probes (first probe 235 and second probe 245), allows the user to treat a target object using both the first probe 235 and the second probe 245, or the user can selectively decouple the second probe 245 from the first probe 235, such that ultrasound energy is transferred only to the first elongated member 220. In this use, the second probe 245 can, for example, serve as a guide catheter. When the probe assembly 210 is inserted into a patient, the user can also selectively couple and decouple the second probe 245 from the first probe 235. For example, in some cases, the user can connect the first probe 235 to a transducer assembly and use the second probe 245 as a guide catheter for inserting the first probe 235 into the patient. Ultrasound energy can be supplied to the first probe and the target tissue to be treated via the transducer of the transducer assembly. The user can then connect the second probe 245 to the first probe 235 (via coupler 230 and second coupler 240) to connect the second probe 245 to the transducer assembly and the transducer, and apply ultrasound energy to the target tissue through both probes. In some cases, the second probe 245 may not be used. In some cases, both the first probe 235 and the second probe 245 are coupled to the transducer and ultrasonic energy is applied to the target tissue through both probes.
[0077] When at least the first probe 235 of probe assembly 210 is coupled to transducer assembly 150 (instead of probe assembly 110), the first elongated member 220 can receive ultrasonic energy from the ultrasonic transducer (e.g., piezoelectric member 162) of transducer assembly 150 and deliver the ultrasonic energy to a target object within the patient's body. Similarly, when the second probe 245 is coupled to the first probe 235, the second elongated member 244 can receive ultrasonic energy from the ultrasonic transducer and deliver the ultrasonic energy to a target object within the patient's body. Because the second (external) probe 245 has a larger diameter, delivering ultrasonic energy through the second probe 245 can create a larger opening through the target tissue (e.g., CTO).
[0078] As described above, for example, a user can engage pedal 172 of foot switch 170, causing ultrasonic generator 180 to generate alternating current (AC) and voltage with a desired ultrasonic frequency (e.g., 20,000 Hz). In this way, ultrasonic generator 180 can supply AC power to piezoelectric member 162. The AC power can cause piezoelectric member 162 to oscillate at a desired frequency (e.g., expand, contract, or otherwise deform), which in turn causes transducer horn 163 to move relative to housing 151. Thus, with probe assembly 210 coupled to transducer horn 163, the movement of transducer horn 163 vibrates and / or moves probe assembly 210, and more specifically, the first elongated member 220 and / or the second elongated member 244 vibrate and / or move when they are coupled to transducer assembly 150.
[0079] In use, the distal portion of probe assembly 210 can be inserted into a patient's blood vessel, adjacent to or penetrating target tissue (e.g., an obstruction such as CTO), such that the first elongated member 220 or the first elongated member 220 and the second elongated member 244 can transfer at least a portion of the ultrasound energy to the target tissue. The distal portion of probe assembly 210 can be inserted into the blood vessel before or after coupling the first probe 235 and / or the second probe 245 to the transducer assembly. In some embodiments, the distal tip or end of the first elongated member 220 can extend beyond the lumen 248 of the second elongated member 244 and impact the target tissue, such as, for example, to break up the occlusion. In some embodiments, movement of the distal portion 222 of the first elongated member 220 causes cavitation to occur within that portion of the patient. In this way, cavitation can also break up the target tissue. As described herein, in some embodiments, probe assembly 210 can optionally be used for aspiration and / or supplying flushing to the target tissue site. For example, the port of the first probe can be coupled to a transfer line that can be used to supply flushing or aspirate particles from blockages at the treatment site.
[0080] In some embodiments, when the first elongated member 220 is at least partially disposed within the lumen 248 of the second elongated member 244, the first elongated member 220 and the second elongated member 244 are coaxial, for example as... Figure 7A As illustrated in the diagram. (For example...) Figure 7A As shown, the first elongated member 220 of the first probe 235 and the second elongated member 244 of the second probe 245 share a common central axis A1 (e.g., they are deployed coaxially). Additionally, the first elongated member 220 has a diameter D1 and the second elongated member 244 has a diameter D2 greater than D1, thereby allowing the first elongated member 220 to be inserted through the second elongated member 244.
[0081] In some embodiments, when the first elongated member is at least partially deployed within the lumen of the second elongated member, the first elongated member may be non-coaxial within the second elongated member. For example, in Figure 7B This arrangement is illustrated schematically. (For example...) Figure 7BAs shown, the first probe 635 includes a first coupler 630 coupled to a first elongated member 620 having a first central axis A1, and the second probe 645 includes a second coupler 640 coupled to a second elongated member 644 having a second axis A2 offset from the first central axis A1. In other words, the first elongated member 620 and the second elongated member 644 are non-axial. In this non-axial configuration, the close proximity, or in some cases contact, between the first elongated member 620 and the second elongated member 644 allows ultrasonic energy to be transferred from the first elongated member 620 to the second elongated member 644 and then to the target tissue, thereby providing a greater amount of ultrasonic energy at the treatment site.
[0082] Although probe assembly 210 is described as comprising two probes (first probe 235 and second probe 245), in other embodiments, probe assembly 210 may include any number of probes. For example, in some embodiments, probe assembly may include more than one “internal” probe. Different internal probes may have different sizes and / or characteristics to facilitate the desired process. For example, in some embodiments, probe assembly may have a third probe (i.e., a second “internal probe”) having a larger dimension than the first probe (e.g., the diameter of an elongated member). The increased size can facilitate better contact with the external probe, thereby enhancing the transmission of ultrasound energy from the internal probe to the external probe (and thus into the target tissue). Figure 7C A third probe 275 is illustrated, which can be used with probe assembly 210 or any other probe assembly described herein. The third probe 275 includes a third elongated member 274 and a third coupler 270. The third elongated member 274 of the third probe 275 has a diameter D3 greater than a diameter D1. In some cases, the third elongated member 274 may have a diameter so large that it cannot be displaced from the distal end of the second elongated member 244. Reference is made below. Figures 9A-9C Example usage of the third probe 275.
[0083] Figure 8 It is the first probe 635 and the second probe 645 ( Figure 7B The diagram shows a probe 635 deployed near a blockage O within a patient's blood vessel V. As described above, in this example illustration, the first probe 635 is deployed non-coaxially with the second probe 645. As the distal portion of the probe assembly 610 is inserted into the blood vessel V near the blockage O, the transducer assembly can be actuated to deliver ultrasound energy into the blockage via a first elongated member 620 of the first probe 635 and a second elongated member 644 of the second probe.
[0084] Figures 9A-9C An example of the use of the probe component as described in this article is illustrated. Figure 9AA schematic diagram of probe assembly 210' is illustrated, which includes a first probe 235 and an alternative second (or external) probe 245' deployed near or within an obstruction O within a patient's blood vessel V. In this example illustration, the first probe 235 and the second probe 245' are deployed coaxially. The second probe 245' can be configured to be identical to the second probe 245' or any second probe described herein. For example, the second probe 245 includes a second elongated member 244'. In this embodiment, the second elongated member 244' includes a tapered distal portion 249'. In some embodiments, the tapered distal portion 249' may be at an angle between 30 and 40 degrees relative to the centerline of the second elongated member 244'. As described above, the second probe 245' can be coupled to the first probe 235 in the same manner as described herein with respect to other embodiments. Figure 9A As shown, the distal tip portion of the first probe 235 extends beyond the second probe 245'. Although not shown, the distal portion of the probe assembly 210' can, in some cases, penetrate into the blockage. As the distal portion of the probe assembly 210' is inserted into or near (or through) the blockage O in the blood vessel V, the transducer assembly can be actuated to deliver ultrasound energy along the first elongated member 220 of the first probe 235, and optionally, along the second elongated member 244' of the second probe 245' and into the blockage. After delivering ultrasound energy to at least partially disrupt the blockage, in this example use, the first probe 235 is disconnected from the transducer assembly and the second probe 245' and removed from the patient's body. Removal of the first probe 235 from within the second probe 245' can be performed, while the second probe 245' remains within the blood vessel V. In some embodiments, the second probe 245' can be repositioned within the blood vessel V to at least partially penetrate the blockage (via the opening created by the initial delivery of ultrasound energy).
[0085] like Figure 9B As shown, the third probe 275 includes a third elongated member 274 inserted through the lumen of the second probe 245'. The third probe 275 includes a third coupler (not shown) to couple the third probe 275 to a coupler (not shown) of the second probe 245'. Figure 9B As shown, the diameter of the third elongated member 274 is larger than the diameter of the first elongated member 220, such that the third elongated member 274 cannot exit through the tapered distal end 249' of the second elongated member 244'. In other words, the third elongated member 274 has a distal tip whose dimensions are designed to restrict movement of the distal tip through the distal tip of the second elongated member 245'. By deploying the third probe 275 within the second probe 245', the distal portions of both the second probe 245' and the third probe 275 can be positioned within the blockage.
[0086] After the third probe 275 is inserted, by moving the second elongated member 244' proximally relative to the third elongated member 274, the coupler of the second probe 245' can be coupled to the coupler of the third probe 275, as follows. Figure 9B As indicated by arrow AA in the diagram. Proximal movement of the second (external) probe 245' causes the tapered distal tip portion 249' of the second elongated member 244' to engage the distal tip portion of the third elongated member 274. As... Figure 9C As indicated by arrow BB, the continuous proximal movement of the second (external) probe 245' (to couple the second probe 245' to the coupler of the third probe 275) deforms the distal portion of the second elongated member 244' and / or the distal portion of the third elongated member 274 to create a contact position C between the third elongated member 274 and the second elongated member 244'. Specifically, this deformation causes contact (or enhances existing contact) between the outer surface of the third elongated member 274 and the inner surface of the second elongated member 244'. Ultrasonic energy can then be transmitted from the ultrasonic transducer assembly to at least the third probe 275, and at least a portion of the ultrasonic energy is delivered from the third elongated member 274 through the contact position C and the second elongated member 244' to the blockage (e.g., Figure 9C (Ultrasonic energy US is shown).
[0087] Figure 10A-13B Another embodiment of an ultrasonic probe assembly is illustrated, which includes two ultrasonic probes and can be coupled to and used in an ultrasonic energy ablation system (such as system 100 described above). In this embodiment, probe assembly 310 includes a first probe 335 (see example...). Figure 12 and 13A ) and a second probe 345 that can be releasably coupled to the first probe 335 (see, for example) Figure 12 and 13B As described in further detail below, the first probe 335 includes a first elongated transmission member 320 (also referred to herein as the "first transmission member" or "first elongated member" or "transmission member" or "elongated member") and a coupler 330. The coupler 330 includes a proximal portion 331 and a distal portion 332 and defines a central lumen 323 that at least partially extends the coupler 330 (see, for example...). Figure 12Coupler 330 also defines a side lumen 324 in fluid communication with the central lumen 323. In some embodiments, a side port (e.g., similar to side port 425 described below) may be coupled to and / or within the side lumen 324 to provide aspiration and / or flushing through the first probe 335. For example, the side lumen 324 may be coupled to and in fluid communication with a transfer line that can be used to supply flushing or aspirate particles from blockages at the treatment site. Embodiments of fluid lines are discussed below with respect to probe assembly 410. In other embodiments, coupler 330 may not need to include a side lumen, but may only include a central lumen passing through it to facilitate aspiration and / or flushing. The proximal portion 331 of coupler 330 includes a first coupling portion 334 configured to releasably couple to a probe coupler (see, for example, the distal portion 165 of transducer assembly 150) at the distal portion of the transducer assembly (e.g., the distal portion 165 of transducer assembly 150). Figure 2 (Threaded probe coupler 168 in the example). For instance, in this embodiment, the first coupling portion 334 is a threaded coupler that is threadedly coupled within the transducer assembly 150 to a mating threaded probe coupler 168 within a lumen 166 at the distal portion 165 of the transducer horn 163. In this way, the first probe 335 can be removably coupled to the transducer assembly 150 via a coupler 330. The coupler 330 also includes two flat, serrated surfaces 337, which can be used to receive tools to help secure the coupler 330 to the probe coupler. For example, a tool such as a medical wrench can be clamped onto the surfaces 337 and used to fasten the coupler 330 to the probe coupler.
[0088] The distal portion 332 of the coupler 330 is configured to receive a portion of the transmission member 320 to securely couple the transmission member 320 to the coupler 330 (i.e., within the central lumen 323). The transmission member 320 includes a proximal portion 321 and a distal portion 322. The proximal portion 321 is securely coupled to the distal portion 332 of the coupler 330. The distal portion 322 is configured for insertion into a patient, as described in more detail below. As described above, the first probe 335 also includes a second coupling portion 336 to releasably couple the first probe 335 to the second probe 345.
[0089] The second probe 345 includes an elongated transmission member 344 (also referred to herein as the "second transmission member," "second elongated member," "transmission member," or "elongated member") and a coupler 340. The coupler 340 includes a proximal portion 343 and a distal portion 347 and defines a lumen 339 extending at least partially through it (see, for example...). Figure 12The transmission member 344 includes a proximal portion 341 and a distal portion 342. The proximal portion 341 is fixedly coupled to the distal portion 347 of the coupler 340. The proximal portion 343 of the coupler 340 includes a coupling portion 346 (also referred to herein as a “third coupling portion”) configured to be releasably coupled to a second coupling portion 336 of the first probe 335. Thus, the second probe 345 can be removably or releasably coupled to the transducer assembly 150 via the first probe 335 (e.g., via the coupler 330). In this way, both the first probe 335 and the second probe 345 can be coupled to the same transducer assembly and driven by the same ultrasonic transducer. More specifically, the lumen 348 of the second probe 345 can receive at least a portion of the first elongated member 320 of the first probe 335, and the coupler 340 can be releasably coupled to the coupler 330. For example, the elongated member 320 of the first probe 335 can be inserted through a lumen 348 of the second elongated member 344, such that the distal end of the first elongated member 320 extends beyond the lumen 348. In this embodiment, the second coupling portion 336 is a threaded coupling member and the third coupling portion 346 is a threaded coupling member to thread the first probe 335 to the second probe 345. The second probe 345 may also include a tapered distal portion, which may be incorporated into the second elongated member 344 or provided as a separate component. This embodiment will be referred to below with reference to a probe assembly 410 including a tapered distal portion 449 or an alternative second probe 245' including a tapered distal portion 249'. Figures 9A-9C (As shown in the diagram) will be discussed further. The tapered distal portion of the second probe 345 can assist in inserting the probe assembly 310 into the tissue to be treated. In this way, the second elongated member 344 can be used as a guiding catheter, as described below. By extending distally outside the lumen 348, the distal portion 322 of the elongated member 320 can be advanced into the target tissue.
[0090] The first elongated member 320 and the second elongated member 344 may each have any suitable shape, size, or configuration as described herein. In some embodiments, the elongated members 320 and 344 may optionally include any suitable features configured to increase the flexibility (e.g., reduce stiffness) of at least a portion of the transmission members 320, 344, thereby facilitating the passage of the elongated members 320, 344 through tortuous lumens (e.g., urinary tract, veins, arteries, etc.) within a patient's body. For example, in some embodiments, a portion of the elongated members 320 and / or 344 may be formed of a material with lower stiffness, while different portions of the elongated members 320, 344 may be formed of a material with higher stiffness. In some embodiments, the stiffness of at least a portion of the elongated members 320 and / or 344 can be reduced by defining openings (e.g., notches, grooves, channels, cuts, etc.) in the elongated members 320 and / or 344 or by providing openings in the woven material in which the elongated members 320 and / or 344 may be formed, thereby reducing the area moment of inertia of that portion of the transmission members 320, 344.
[0091] Additionally, the first elongated member 320 may be formed of the same or a different material as the second elongated member 344. In some embodiments, the second elongated member 344 is formed of a more flexible material than the first elongated member 320. In other words, the first elongated member 320 has greater stiffness than the second elongated member 344. In some embodiments, the second elongated member 344 is formed of braided metal. The braided material may be the same as the braided material used for the elongated member 244 described above.
[0092] As described above with reference to the previous embodiments, when the first elongated member 320 is at least partially deployed within the lumen 348 of the second elongated member 344, the first elongated member 320 may be deployed coaxially with the second elongated member 344. In other embodiments, when the first elongated member 320 is at least partially deployed within the lumen 348 of the second elongated member 344, the first elongated member 320 and the second elongated member 344 are not coaxial. In this non-coaxial configuration, the close proximity, or in some cases contact, between the first elongated member 320 and the second elongated member 344 allows ultrasonic energy to be transferred from the first elongated member 320 to the second elongated member 344 and then to the target tissue, thereby providing a greater amount of ultrasonic energy at the treatment site.
[0093] As described above with reference to the preceding embodiments, in use, a user (e.g., a surgeon, technician, physician, etc.) can operate the ultrasound system 100 (as described above) to deliver ultrasound energy to target body tissues within a patient. For example, the ultrasound system 100 and probe assembly 310 can be used to treat a patient's chronic total occlusion (CTO).
[0094] The probe assembly 310, having two ultrasound probes (first probe 335 and second probe 345), allows the user to treat a target object using both the first probe 335 and the second probe 345, or the user can selectively decouple the second probe 345 from the first probe 335, such that ultrasound energy is transferred only to the first elongated member 320. In this use, the second probe 345 can, for example, be used as a guiding catheter. When the probe assembly 310 is inserted into a patient, the user can also selectively couple and decouple the second probe 345 from the first probe 335. For example, in some cases, the user can connect the first probe 335 to a transducer assembly and use the second probe 345 as a guiding catheter for inserting the first probe 335 into the patient. Ultrasound energy can be supplied to the first probe and the target tissue to be treated via the transducer of the transducer assembly. The user can then connect the second probe 345 to the first probe 335 (via coupler 330 and second coupler 340) to connect the second probe 345 to the transducer assembly and the transducer, and apply ultrasound energy to the target tissue through both probes. In some cases, the second probe 345 may not be used. In some cases, both the first probe 335 and the second probe 345 are coupled to the transducer and ultrasonic energy is applied to the target tissue through both probes.
[0095] When at least the first probe 335 of probe assembly 310 is coupled to transducer assembly 150 (instead of probe assembly 110), the first elongated member 320 can receive ultrasonic energy from the ultrasonic transducer (e.g., piezoelectric member 162) of transducer assembly 150 and deliver the ultrasonic energy to a target object within the patient's body. Similarly, when the second probe 345 is coupled to the first probe 335, the second elongated member 344 can receive ultrasonic energy from the ultrasonic transducer and deliver the ultrasonic energy to a target object within the patient's body. Because the second (external) probe 345 has a larger diameter, delivering ultrasonic energy through the second probe 345 creates a larger opening through the target tissue (e.g., CTO).
[0096] As described above, for example, a user can engage pedal 172 of foot switch 170, causing ultrasonic generator 180 to generate alternating current (AC) and voltage with a desired ultrasonic frequency (e.g., 20,000 Hz). In this way, ultrasonic generator 180 can supply AC power to piezoelectric member 162. The AC power can cause piezoelectric member 162 to oscillate at a desired frequency (e.g., expand, contract, or otherwise deform), which in turn causes transducer horn 163 to move relative to housing 151. Thus, as probe assembly 310 is coupled to transducer horn 163, the movement of transducer horn 163 vibrates and / or moves probe assembly 310, and more specifically, when first elongated member 320 and / or second elongated member 344 are coupled to transducer assembly 150, the first elongated member 320 and / or second elongated member 344 vibrates and / or moves.
[0097] In use, the distal portion of probe assembly 310 can be inserted into a patient's blood vessel, adjacent to or penetrating target tissue (e.g., an obstruction, such as CTO), such that the first elongated member 320 or the first elongated member 320 and the second elongated member 344 can transfer at least a portion of the ultrasound energy to the target tissue. The distal portion of probe assembly 310 can be inserted into the blood vessel before or after coupling the first probe 335 and / or the second probe 345 to the transducer assembly. In some embodiments, the distal tip or end of the first elongated member 320 can extend beyond the lumen 348 of the second elongated member 344 and impact the target tissue, such as, for example, to break up the occlusion. In some embodiments, movement of the distal portion 322 of the first elongated member 320 causes cavitation to occur within that portion of the patient. In this way, cavitation can also break up the target tissue. As described herein, in some embodiments, probe assembly 310 can optionally be used for aspiration and / or supply perfusion to the target tissue site. For example, the port of the first probe can be coupled to a transfer line that can be used to supply flushing or aspirate particles from blockages at the treatment site.
[0098] Figure 14-19 Another embodiment of an ultrasonic probe assembly is illustrated, which includes two ultrasonic probes and can be coupled to and used in an ultrasonic energy ablation system (such as system 100 described above). In this embodiment, probe assembly 410 includes a first probe 435 (see example...). Figure 15A ) and the second probe 445 (see example) Figure 15BThe second probe 445 can be releasably coupled to the first probe 435, as described in further detail below. The first probe 435 includes a first elongated transmission member 420 (also referred to herein as the "first transmission member," "first elongated member," "transmission member," or "elongated member") and a coupler 430. The coupler 430 includes a proximal portion 431 and a distal portion 432 and defines a central lumen (not shown) extending at least partially through therethrough. The proximal portion 431 of the coupler 430 includes a first coupling portion 434 configured to releasably couple to the probe coupler (see, for example, the distal portion 165 of the transducer assembly) at the distal portion of the transducer assembly (e.g., the distal portion 165 of the transducer assembly 150). Figure 2 (The threaded probe coupling 168 in the example). For instance, in this embodiment, the first coupling portion 434 is a threaded coupling that is threaded within the transducer assembly 150 to a mating threaded probe coupling 168 within a lumen 166 at the distal portion 165 of the transducer horn 163. In this way, the first probe 435 can be removably coupled to the transducer assembly 150 via the coupler 430. The coupler 430 also includes two flat, serrated surfaces 437, which can be used to receive tools to help secure the coupler 430 to the probe coupling. For example, a tool such as a medical wrench can be clamped onto the surfaces 437 and used to fasten the coupler 430 to the probe coupling.
[0099] The distal portion 432 of coupler 430 is configured to receive a portion of transmission member 420 to securely couple transmission member 420 to coupler 430 (i.e., within the central lumen of coupler 430). Transmission member 420 includes a proximal portion 421 and a distal portion 422. Proximal portion 421 is securely coupled to distal portion 432 of coupler 430. Distal portion 432 is configured for insertion into a patient, as described in more detail herein. As described above, first probe 435 also includes a second coupling portion 436 to releasably couple first probe 435 to second probe 445.
[0100] The second probe 445 includes an elongated transmission member 444 (also referred to herein as a "second transmission member," "second elongated member," "transmission member," or "elongated member") and a coupler 440. The coupler 440 includes a proximal portion 443 and a distal portion 447 and defines a lumen 439 extending at least partially through it. The transmission member 444 includes a proximal portion 441 and a distal portion 442. The proximal portion 441 is fixedly coupled to the distal portion 447 of the coupler 440. The proximal portion 443 of the coupler 440 includes a coupling portion 446 configured to releasably couple to a second coupling portion 436 of the first probe 435 (see, for example...). Figure 18C(Also referred to herein as the “third coupling portion”). Therefore, the second probe 445 can be removably or releasably coupled to the transducer assembly 150 via the first probe 435 (e.g., via coupler 430). In this way, both the first probe 435 and the second probe 445 can be coupled to the same transducer assembly and driven by the same ultrasonic transducer. More specifically, the lumen of the second probe 445 can receive at least a portion of the first elongated member 420 of the first probe 435, and the coupler 440 can be releasably coupled to the coupler 430. For example, the elongated member 420 of the first probe 435 can be inserted through the lumen of the second elongated member 444, such that the distal end of the first elongated member 420 extends beyond the lumen 448, for example, as... Figure 14 and 17B As shown in the figure. In this embodiment, the second coupling portion 436 is a threaded coupling element and the third coupling portion 446 is a threaded coupling element (see, for example...). Figure 18C The first probe 435 is threadedly coupled to the second probe 445. The second probe 445 may also include a tapered distal portion 449, which in this embodiment is a separate component coupled to the distal portion 442 of the second elongated member 444. The tapered distal portion 449 of the second probe 445 can assist in inserting the probe assembly 410 into the tissue to be treated. In this way, the second elongated member 444 can be used as a guiding catheter, as described below. By extending distally outside the lumen 448, the distal portion 422 of the elongated member 420 can be advanced into the target tissue. In some embodiments, the tapered distal portion 449 may provide an angled distal end at an angle between 30 and 40 degrees relative to the centerline of the second elongated member 444.
[0101] The first coupler 430 also includes a port 425 in fluid communication with the central lumen of the first elongated member 420. Port 425 can be used for aspiration and / or supplying flushing to a target tissue site. Port 425 is coupled to a transfer line 426, which can be connected via a connector 427 (see example...). Figure 14 and 15A It is coupled to a fluid source or treatment container. Port 425 and fluid line 426 can be used to supply flushing or aspirate particles from blockages at the treatment site.
[0102] The first elongated member 420 and the second elongated member 444 can each have any suitable shape, size, or construction as described herein. In this embodiment, the first elongated member 420 is formed of a metal such as stainless steel, while the second elongated member 444 is formed of a braided metal material. The braided metal of the second elongated member 444 is more flexible than the stainless steel of the first elongated member 420. Therefore, the first elongated member 420 is more rigid than the second elongated member 444. In an alternative embodiment, the first elongated member 420 can be formed of the same material as the second elongated member 444. The combination of the flexible braided second elongated member 444 and the more rigid inner elongated member 420 provides the probe assembly 410 with both strength and flexibility to manipulate the probe assembly 410 through a patient's blood vessels.
[0103] In some embodiments, elongated members 420 and 444 may optionally include any suitable feature configured to increase the flexibility (e.g., reduce stiffness) of at least a portion of the transmission members 420 and 444, thereby facilitating the passage of the elongated members 420 and 444 through tortuous lumens (e.g., urinary tract, vein, artery, etc.) within a patient's body. For example, in some embodiments, a portion of the elongated members 420 and / or 444 may be formed of a material with lower stiffness, while different portions of the elongated members 420 and 444 may be formed of a material with higher stiffness. In some embodiments, the stiffness of at least a portion of the elongated members 420 and / or 444 may be reduced by defining openings (e.g., notches, grooves, channels, cuts, etc.) in the elongated members 420 and / or 444 or by providing openings within a woven material in which the elongated members 420 and / or 444 may be formed, thereby reducing the area moment of inertia of portions of the transmission members 420 and 444.
[0104] As described above with reference to the previous embodiments, when the first elongated member 420 is at least partially deployed within the lumen of the second elongated member 444, the first elongated member 420 may be deployed coaxially with the second elongated member 444. In other embodiments, when the first elongated member 420 is at least partially deployed within the lumen 448 of the second elongated member 444, the first elongated member 420 and the second elongated member 444 are not coaxial. In this non-coaxial configuration, the close proximity, or in some cases contact, between the first elongated member 420 and the second elongated member 444 allows ultrasonic energy to be transferred from the first elongated member 420 to the second elongated member 444 and then to the target tissue, thereby providing a greater amount of ultrasonic energy at the treatment site.
[0105] As described above with reference to the previous embodiments, in use, a user (e.g., a surgeon, technician, physician, etc.) can operate the ultrasound system 100 (as described above) to deliver ultrasound energy to target body tissues within a patient. For example, the ultrasound system 100 and probe assembly 410 can be used to treat a patient's chronic total occlusion (CTO).
[0106] The probe assembly 410, having two ultrasound probes (first probe 435 and second probe 445), allows the user to treat a target object using both the first probe 435 and the second probe 445, or the user can selectively decouple the second probe 445 from the first probe 435, such that ultrasound energy is transferred only to the first elongated member 420. In this use, the second probe 445 can be used, for example, as a guide catheter. The user can also selectively couple and decouple the second probe 445 from the first probe 435 when the probe assembly 410 is inserted into the patient. For example, in some cases, the user can connect the first probe 435 to the transducer assembly and use the second probe 445 as a guide catheter for inserting the first probe 435 into the patient. Ultrasound energy can be provided to the first probe and the target tissue to be treated via the transducer of the transducer assembly. The user can then connect the second probe 445 to the first probe 435 (via coupler 430 and second coupler 440) to connect the second probe 445 to the transducer assembly and the transducer, and apply ultrasound energy to the target tissue through both probes. In some cases, the second probe 445 may not be used. In some cases, both the first probe 435 and the second probe 445 are coupled to the transducer and ultrasonic energy is applied to the target tissue through both probes.
[0107] When at least the first probe 435 of probe assembly 410 is coupled to transducer assembly 150 (but not probe assembly 110), the first elongated member 420 can receive ultrasonic energy from the ultrasonic transducer (e.g., piezoelectric member 162) of transducer assembly 150 and deliver the ultrasonic energy to a target object within the patient's body. Similarly, when the second probe 445 is coupled to the first probe 435, the second elongated member 444 can receive ultrasonic energy from the ultrasonic transducer and deliver the ultrasonic energy to a target object within the patient's body. Because the second (external) probe 445 has a larger diameter, delivering ultrasonic energy through the second probe 445 can create a larger opening through the target tissue (e.g., CTO).
[0108] As described above, for example, a user can engage pedal 172 of foot switch 170, causing ultrasonic generator 180 to generate alternating current (AC) and voltage with a desired ultrasonic frequency (e.g., 20,000 Hz). In this way, ultrasonic generator 180 can supply AC power to piezoelectric member 162. The AC power can cause piezoelectric member 162 to oscillate at a desired frequency (e.g., expand, contract, or otherwise deform), which in turn causes transducer horn 163 to move relative to housing 151. Thus, when probe assembly 410 is coupled to transducer horn 163, the movement of transducer horn 163 vibrates and / or moves probe assembly 410, and more specifically, when first elongated member 420 and / or second elongated member 444 are coupled to transducer assembly 150, the first elongated member 420 and / or second elongated member 444 vibrates and / or moves.
[0109] In use, the distal portion of probe assembly 410 can be inserted into a patient's blood vessel, adjacent to or penetrating target tissue (e.g., an obstruction such as CTO), such that the first elongated member 420 or the first elongated member 420 and the second elongated member 444 can transfer at least a portion of the ultrasound energy to the target tissue. The distal portion of probe assembly 420 can be inserted into the blood vessel before or after coupling the first probe 435 and / or the second probe 445 to the transducer assembly. In some embodiments, the distal tip or end of the first elongated member 420 can extend beyond the lumen of the second elongated member 444 and impact the target tissue, such as, for example, to break up the occlusion. In some embodiments, movement of the distal portion 422 of the first elongated member 420 causes cavitation to occur within that portion of the patient. In this way, cavitation can also break up the target tissue.
[0110] Figure 20This is a flowchart illustrating a method 580 for transferring ultrasound energy to target tissue within a patient using an ultrasound probe assembly as described herein, according to an embodiment. In some embodiments, method 580 includes inserting or introducing at least a distal portion of a probe assembly (e.g., probe assemblies 210, 310, 410) into a blood vessel of the patient at 581. The probe assembly may include a first probe and a second probe, each of which is coupleable to an ultrasound transducer assembly (e.g., 150) of an ultrasound ablation system (e.g., 100). The first probe includes a first coupler and a first elongated member coupled to the first coupler, and is coupleable to the transducer assembly via the first coupler. The second probe includes a second coupler and a second elongated member coupled to the second coupler, and the second coupler is releasably coupled to the first coupler such that the second probe is coupled to the ultrasound transducer assembly via the first probe. In some embodiments, the second probe is coupled to the first probe by inserting the first elongated member of the first probe through a lumen of the second probe before introducing the distal portion of the probe assembly into the blood vessel, such that the distal tip portion of the first elongated member extends beyond the lumen of the second elongated member.
[0111] At 582, the distal portion of the ultrasound probe assembly is moved through the blockage in the blood vessel, such that the distal portion of the first elongated member penetrates the blockage and the distal portion of the second elongated member penetrates the blockage. At 583, ultrasound energy is transferred from the ultrasound transducer assembly to the first and second probes, such that the ultrasound energy is delivered to the blockage through the first and second elongated members.
[0112] In some embodiments, after ultrasonic energy is transmitted to the first probe and the second probe, the distal portion of the ultrasonic probe assembly moves from a first position to a second position within the blockage and ultrasonic energy is transmitted to the first probe and the second probe, such that the ultrasonic energy is delivered to the second position within the blockage via the first elongated member and the second elongated member and destroys at least a portion of the blockage.
[0113] In some embodiments, at 584, after the transmission of ultrasonic energy, the second probe is optionally disconnected from the first probe and the ultrasonic transducer assembly, and the first probe is removed from the blood vessel, leaving the second probe deployed within the blood vessel. At 585, a third ultrasonic probe is inserted into the lumen of the second probe. In some embodiments, the third probe has a third coupler and a third elongated member coupled to the third coupler. In some embodiments, the third elongated member has a distal portion with a diameter larger than that of the distal portion of the first elongated member, such that at least a portion of the distal portion of the third elongated member contacts the inner wall of the second elongated member at a contact point on the second elongated member.
[0114] At 586, the third probe is coupled to the ultrasonic transducer assembly, and ultrasonic energy is transmitted to the third probe and the second probe, such that the ultrasonic energy is delivered to the blockage through the third elongated member and the second elongated member. In some embodiments, during the transmission of ultrasonic energy to the third probe, a portion of the distal portion of the third elongated member is delivered to the second elongated member, wherein a portion of the distal portion of the third elongated member contacts the inner wall of the second elongated member at a contact location, such that the ultrasonic energy is delivered to the blockage near the contact location.
[0115] The embodiments and / or components described herein may be packaged independently, or any part of the embodiments may be packaged together as a kit. For example, in some embodiments, the kit may include an ultrasonic transducer assembly (e.g., such as those referenced above). Figure 2 The ultrasonic transducer assembly 150 and probe assemblies (e.g., 210, 310, 410) are as described herein.
[0116] The processor included in any ultrasonic generator can be a general-purpose processor (e.g., a central processing unit (CPU)) or another processor configured to execute one or more instructions stored in memory. In some embodiments, the processor may alternatively be an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA). The processor can be configured to execute specific modules and / or submodules, which can be, for example, hardware modules, software modules stored in memory and executed in the processor, and / or any combination thereof. The memory included in the ultrasonic generator 180 can be, for example, flash memory, one-time programmable memory, random access memory (RAM), memory buffer, hard disk drive, read-only memory (ROM), erasable programmable read-only memory (EPROM), etc. In some embodiments, the memory includes a set of instructions to cause the processor to execute modules, processes, and / or functions for generating, controlling, amplifying, and / or delivering current to another part of the system (e.g., transducer assembly 150).
[0117] Some embodiments described herein, such as those related to the aforementioned ultrasonic generator, relate to computer storage products having non-transitory computer-readable media (also referred to as non-transitory processor-readable media) having instructions or computer code thereon for performing operations of various computer implementations. A computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not itself include transient propagation signals (e.g., propagating electromagnetic waves carrying information over transmission media such as space or cables). The medium and computer code (also referred to as code) may be designed and constructed for one or more specific purposes. Examples of non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as optical discs / digital video discs (CD / DVD), optical disc read-only memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical discs; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as application-specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memories (ROMs), and random access memory (RAM) devices. Other embodiments described herein relate to a computer program product that may include, for example, the instructions and / or computer code discussed herein.
[0118] Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions (such as those generated by a compiler), code for generating web services, and files containing high-level instructions that a computer executes using a translator. For example, embodiments may be implemented using Java, C++, or other programming languages (e.g., object-oriented programming languages) and development tools. Additional examples of computer code include, but are not limited to, control signals, encryption code, and compression code.
[0119] While various embodiments have been described above, it should be understood that they are presented by way of example only and not as limitations. Where the methods and / or diagrams above indicate specific events and / or process patterns occurring in a particular order, the ordering of those specific events and / or process patterns can be modified. Furthermore, certain events may be executed concurrently in parallel processes where possible, or sequentially. Although embodiments have been specifically shown and described, it should be understood that various changes in form and detail are possible. While various embodiments have been described as combinations of specific features and / or components, other embodiments are possible, where appropriate, with combinations of any features and / or components from any embodiment.
[0120] For example, the probe assemblies described above (110, 210, 310, 410) can be used in any suitable ultrasonic energy system, such as a reference... Figure 1 and 2The ultrasound energy system 100 is described. As described above, the first and second probes of the probe assembly can be coupled and decoupled from each other to allow the user to selectively use only the first probe or both the first and second probes of the probe assembly to treat a target object. The elongated transmission member of the probe assembly described herein can have various shapes and sizes (e.g., diameter, length, etc.). For example, in some embodiments, the outer elongated transmission member can have an outer diameter between 0.95 mm and 2.5 mm and an inner diameter between 0.5 mm and 2.3 mm, and the inner elongated transmission member can have an outer diameter between 0.4 mm and 2.2 mm and an inner diameter between 0.1 mm and 2.0 mm. In some embodiments, the outer elongated transmission member can have a length between 450 mm and 1790 mm, and the inner elongated transmission member can have a length between 460 mm and 1800 mm.
[0121] Although transducer assembly 150 is in Figure 2 The transducer assembly is shown to include two insulators 161 and two piezoelectric rings 162, but in other embodiments, the transducer assembly may include any suitable number of insulators 161 and / or piezoelectric rings 162 in any suitable arrangement. Furthermore, the insulators 161 may be formed of any suitable insulating material, ceramic material (e.g., polyamide, expanded polytetrafluoroethylene (EPTFE), etc.). Similarly, the piezoelectric rings 162 may be any suitable piezoelectric material (e.g., lead zirconate titanate (PZT-5), PZT-8, lead titanate (PT), lead metaniobate (PbNbO 6), polyvinylidene fluoride (PVDF), etc.).
Claims
1. A device for ablation, comprising: A transducer assembly, including a transducer housing and an ultrasonic transducer deployed within the transducer housing; A transducer horn, at least partially deployed within the transducer housing, and including a probe coupler; The first probe includes a first coupler and a first elongated member coupled to the first coupler. The first coupler has a first coupling portion and a second coupling portion. The first coupling portion is configured to be releasably and directly coupled to a probe coupler to a transducer horn, such that the first probe is coupled to an ultrasonic transducer. as well as The second probe includes a second coupler and a second elongated member coupled to the second coupler. The second coupler has a third coupling portion that can be releasably coupled directly to the second coupling portion of the first coupler, such that the second probe is coupled to the ultrasonic transducer. Each of the first elongated member and the second elongated member is configured to receive ultrasonic energy from the ultrasonic transducer and deliver the ultrasonic energy to the target object inside the patient's body when the second probe is coupled to the first probe.
2. The apparatus of claim 1, wherein the first coupling portion is a threaded coupling member and the probe coupling member is a threaded coupling member, such that the first probe can be threadedly coupled to the transducer horn.
3. The apparatus of claim 1, wherein the second coupling portion of the first probe is a threaded coupling element and the third coupling portion of the second coupler is a threaded coupling element, such that the second probe can be threadedly coupled to the first coupler.
4. The apparatus of claim 1, wherein the second elongated member of the second probe includes a proximal end and a distal end and defines a lumen between the proximal end and the distal end, and the first elongated member of the first probe is configured to be deployed at least partially within the lumen of the second elongated member.
5. The apparatus of claim 4, wherein when the first elongated member is at least partially disposed within the lumen of the second elongated member, the first elongated member and the second elongated member are coaxial.
6. The apparatus of claim 4, wherein the centerline of the first elongated member is offset from the centerline of the second elongated member.
7. The apparatus of claim 1, wherein the first elongated member is formed of a first material, and the second elongated member is formed of a second material different from the first material.
8. The apparatus of claim 7, wherein the second material is braided metal.
9. The apparatus of claim 1, wherein the first elongated member has a greater stiffness than the second elongated member.
10. The device of claim 1, wherein the second elongated member is more flexible than the first elongated member.
11. The apparatus of claim 1, wherein: The first elongated member has a proximal end and a distal end and defines a lumen extending between the proximal end and the distal end; The first coupler defines a port in fluid communication with the lumen of the first elongated member, and the device further includes: The transfer line is coupled to the first probe and fluidly communicated with the port.
12. The apparatus of claim 1, further comprising: A third probe has a third coupler and a third elongated member coupled to the third coupler. The third elongated member has a distal portion with a diameter larger than that of the distal portion of the first elongated member, such that at least a portion of the distal portion of the third elongated member contacts the inner wall of the second elongated member at a contact position on the second elongated member. The third elongated member is configured to receive ultrasonic energy from the ultrasonic transducer and deliver the ultrasonic energy to the third and second probes, such that the ultrasonic energy is delivered to the target object through the third and second elongated members.
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