Catheter system for treating calcified plaque

Abstract

A catheter system may include a longitudinal pressure wave generator that generates longitudinal pressure waves. The longitudinal pressure wave generator may be coupled to the proximal end portion of the catheter body to enable delivery of the generated longitudinal pressure waves to the catheter body. The catheter body may be configured to enable the longitudinal pressure waves from the longitudinal pressure wave generator to propagate through the catheter body toward the distal end portion of the catheter body, and to deliver the propagated longitudinal pressure waves to a calcified plaque at the treatment site. The catheter system may include a treatment member body and a plurality of fins coupled to the treatment member body. The plurality of fins can be deployed using an actuator.

Description

Technical Field

[0001] The present technology generally relates to a catheter system and method for treating calcified plaque within the body of a subject. Background Art

[0002] A variety of techniques and instruments have been developed to percutaneously treat calcified plaques in the body of a subject. As an example, calcified plaques can accumulate in the circulatory system of a subject. A common example is the accumulation of fat deposits (atheroma) in the intimal layer (under the endothelium of a patient's blood vessel). Over time, the relatively soft, cholesterol-rich atheromatous material initially deposited usually hardens into a calcified atherosclerotic plaque. Atherosclerosis can be referred to as a stenotic lesion or stenosis, and the obstructive material can be referred to as a stenotic material. If not treated, this stenosis may severely reduce perfusion, so that it may cause angina, hypertension, myocardial infarction, stroke, etc. Angioplasty or plaque removal (atherectomy) can be performed to improve blood flow. However, the presence of calcified plaques usually results in difficulty in fully treating blood vessels. Summary of the invention

[0003] The technology of the present disclosure generally relates to a catheter system and method for treating calcified plaque within the body of a subject.

[0004] In one aspect, the present disclosure provides a catheter system for treating calcified plaque in a subject's body. The catheter system includes a catheter body having opposing proximal and distal portions and a longitudinal axis extending therebetween, wherein the catheter body is configured to be percutaneously inserted into a subject's body and delivered to a treatment site having calcified plaque.

[0005] The invention relates to a method for treating a calcified plaque at a treatment site, wherein the longitudinal pressure wave generator can be connected to the proximal portion of the catheter body so that the generated longitudinal pressure wave can be delivered to the catheter body. The catheter body is configured so that the longitudinal pressure wave from the longitudinal pressure wave generator can propagate through the catheter body toward the distal portion of the catheter body and the propagated longitudinal pressure wave is delivered to the calcified plaque at the treatment site.

[0006] In another aspect, the present disclosure provides a method for treating calcified plaque at a treatment site within a subject's body. The method includes: delivering a catheter body of a catheter system to the treatment site so that a distal portion of the catheter body is adjacent to the calcified plaque; propagating a longitudinal pressure wave from a proximal portion of the catheter body through the catheter body toward a distal portion of the catheter body; and delivering the longitudinal pressure wave from the distal portion of the catheter body to the calcified plaque.

[0007] On the other hand, the present disclosure provides a catheter system for treating calcified plaques in a subject's body. The catheter system includes a catheter body having opposite proximal and distal portions and a longitudinal axis extending therebetween. The catheter body is configured to be percutaneously inserted into the subject's body and delivered to a treatment site having calcified plaques. A treatment member is at the distal portion of the catheter body. The treatment member includes a treatment member body and a plurality of fins coupled to the treatment member body. The treatment member can be selectively configured between a non-deployed configuration and a deployed configuration, in which the fins are generally flush with the treatment member body, and in which the fins protrude radially outward from the treatment member body. The actuator is configured to enable a user to configure the treatment member between the non-deployed configuration and the deployed configuration.

[0008] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in the disclosure will become apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a schematic diagram of an example of a catheter system for treating calcified plaque, showing a propagating longitudinal pressure wave.

[0010] Figure 2 is a schematic diagram of a distal portion of a catheter system for treating calcified plaque within a body lumen.

[0011] Figure 3 is a schematic diagram of a longitudinal pressure wave.

[0012] Figure 4 is a schematic diagram of another example of a catheter system showing a distal portion of the catheter system for treating calcified plaque in a body lumen.

[0013] Figure 5 is a schematic diagram of yet another example of a catheter system showing a distal portion of the catheter system for treating calcified plaque in a body lumen.

[0014] Figure 6 is a schematic diagram of another example of a catheter system including a therapeutic member at a distal end thereof, the therapeutic member being in a non-deployed configuration.

[0015] Figure 7 yes Figure 6 Cross-section of the distal portion of a catheter system.

[0016] Figure 8 Similar to Figure 6 , but the treatment component is in the deployed configuration.

[0017] Fig. 9 yes Figure 8 Cross-section of the distal portion of a catheter system. DETAILED DESCRIPTION

[0018] The following description generally relates to an example of a therapeutic catheter system for treating calcified plaque in a subject's body. The illustrated example is suitable for treating calcified plaque in a subject's circulatory system (such as a subject's blood vessels and / or heart). The illustrated example may also be suitable for treating other body cavities outside of the circulatory system.

[0019] refer to Figure 1 , an example of a catheter system for treating calcified plaque in a subject's body is generally indicated by reference numeral 10. Generally, the catheter system 10 is configured to deliver longitudinal pressure waves to the calcified plaque. The longitudinal pressure waves alter or disrupt the calcified plaque. For example, the longitudinal waves may rupture the calcified plaque, thereby facilitating treatment. In one example, the calcified plaque can be further treated, such as by angioplasty or plaque removal or other treatment, or the treatment using the longitudinal waves can be the primary treatment or sole treatment for the calcified plaque.

[0020] Still reference Figure 1 , catheter system 10 comprises catheter body 12, and this catheter body has proximal part and distal part and the longitudinal axis extending between them.Catheter body 12 is designed and constructed to be inserted in experimenter's blood vessel percutaneously, so that the distal part of catheter body is delivered to the treatment site that comprises calcified plaque.As non-limiting example, catheter body 12 can have the length from about 150mm to about 400mm, and the diameter from about 0.014 inch (0.3556mm) to about 0.120 inch (3.048mm).Catheter body 12 can suitably comprise flexible material (such as plastics) so that this body can arrive treatment site through tortuous path.

[0021] The longitudinal pressure wave generator 14 of the catheter system 10 is configured to generate at least one longitudinal pressure wave LPW. The generator 14 is operatively connected or capable of being connected to the proximal portion of the catheter body 12 to deliver the generated longitudinal pressure wave LPW to the catheter body. The generator 14 is outside the patient's body and may be any suitable device for generating a longitudinal pressure wave LPW. For example, the generator 14 may include a device for generating a hydraulic shock (i.e., a water hammer). In such a system, the longitudinal pressure wave LPW is generated by suddenly stopping or changing the direction of a fluid (e.g., a liquid). Other ways of generating a longitudinal pressure wave LPW include i) using a piston; ii) using a mechanical trigger or hammer action; and / or iii) a controlled explosion or rapid expansion of a compressed gas (e.g., air). A suitable longitudinal pressure wave generator 14 is described in U.S. Serial No. 14 / 655,639 filed on June 25, 2015, the entire contents of which are incorporated herein by reference. A typical pressure wave generated by the pressure wave generator 14 is Figure 3 Shown in.

[0022] refer to Figure 1 and Figure 2 , the generated longitudinal pressure wave LPW propagates from the generator 14 and enters the proximal portion of the catheter body 12. The connector or interface 16 can connect the catheter body 12 to the generator 14 so that the longitudinal pressure wave LPW can be transmitted into the catheter body 12. The generated pressure wave propagates longitudinally toward the distal portion through the catheter body 12 via a medium (e.g., blood, saline or other suitable medium) disposed in the internal channel of the catheter body 12. The side wall of the catheter body 12 can be configured to limit energy loss when the pressure wave propagates toward the distal end of the catheter body 12. For example, the wall of the catheter body 12 may include suitable insulating and / or reflective materials to reduce or limit the absorption or transmission of the pressure wave LPW through the side wall of the catheter body 12 to limit the energy loss within the catheter body 12 when the pressure wave propagates distally.

[0023] like Figure 2As shown, the pressure wave being propagated leaves the distal portion of the catheter body 12 to guide the wave energy toward the calcified plaque. In one example, the distal end of the catheter body 12 is configured to enable the pressure wave energy to be delivered to the calcified plaque. In one example, the distal end is open so that the wave energy is directly propagated into the fluid (e.g., blood) and / or the calcified plaque at the treatment site. In another example, the distal end may include an interface material different from the material of the sidewall of the catheter body 12, so that energy is transmitted through the distal end of the catheter body 12. In one example, the interface material may have an impedance that is substantially matched or similar to the impedance of the medium in the catheter body 12 to limit the refraction of the pressure wave. The impedance can also be substantially matched or similar to the impedance of the fluid at the treatment site to limit refraction. The propagation of the wave energy at the treatment site through the fluid is suitable for changing or destroying the calcified plaque.

[0024] The user can control the activation of the pressure waves using the control unit 17. The control unit 17 may include a controller (e.g., a processor and a memory) and a user interface 18. The controller communicates with the longitudinal pressure wave generator 14, and the user interface 18 enables communication between the user and the controller. The user interface 18 may include a touch screen or other interface. The energy of the pressure waves generated by the generator 14 can be tuned or calibrated to produce a desired safety effect on the calcified plaque at the treatment site. As an example, the desired energy can be tuned by adjusting one or more parameters of the pressure wave (including but not limited to frequency and wavelength) to produce a desired speed of the pressure wave. The energy of the pressure wave can be selectively adjusted by the user (such as through the user interface 18) during the medical procedure, or the energy of the pressure wave can be fixed and non-adjustable. The generator 14 can be calibrated to produce the desired energy before the procedure.

[0025] In one example, the catheter system 10 can further include a material removal device (such as an aspirator 20) for removing any debris (e.g., tissue) that is dislodged from the treatment site during treatment. The aspirator 20 can include an aspiration lumen 22 extending from adjacent the distal portion to the proximal portion along the catheter body 12. A negative pressure source 24 (e.g., a vacuum source) is in fluid communication with the proximal portion of the aspiration lumen 22 and is configured to aspirate dislodged debris into the aspiration lumen and into a collection container.

[0026] refer to Figure 4Another embodiment of a catheter system for treating calcified plaque in a subject's body is generally indicated by reference numeral 110. Similar to the first catheter system 10, the present catheter system 110 is configured to deliver longitudinal pressure waves LPW to the calcified plaque. The longitudinal pressure waves change or destroy the calcified plaque. The catheter body 112, the pressure wave generator (not shown), the control unit (not shown), and the aspirator (not shown) can be similar or identical to the corresponding catheter body 12, the pressure wave generator 14, and the controller 16.

[0027] The catheter system 110 further includes at least one barrier (e.g., a first barrier 130 and a second barrier 132) at the distal portion of the catheter body 112, which is configured to engage a body lumen (e.g., a blood vessel) adjacent to the treatment site to guide wave energy toward the calcified plaque. In the example shown, the first barrier 130 and the second barrier 132 are respectively the proximal barrier and the distal barrier spaced apart. As an example, the barriers 130, 132 can be selectively inflatable or expandable to engage the balloon of the inner surface of the body lumen. The proximal balloon 130 can be adjacent to the distal end of the catheter body 112 and on the proximal side of the distal end of the catheter body (or usually on the proximal side of the position where the pressure wave leaves the catheter system at the treatment site). The distal balloon 132 is on the distal side of the distal end of the catheter body 112 and is spaced apart from the distal end of the catheter body (or usually on the distal side of the position where the pressure wave leaves the catheter system at the treatment site). The distal balloon 132 can be arranged on an extension shaft 136 extending from the distal portion of the catheter body 112. The inflated proximal and distal balloons 130, 132 within the body lumen enable the wave energy to enter a suitable medium (eg, a suitable fluid) to propagate toward the calcified plaque. The balloons 130, 132 essentially create a propagation chamber for the pressure waves.

[0028] In one example, the catheter system 110 can be configured to allow a suitable medium to be delivered to the propagation chamber formed. The medium can be the same medium as that present in the catheter body 112. In one example, a suitable flowable medium (e.g., a liquid medium) can be injected into the catheter body 112 and delivered through the distal end of the catheter system to the propagation chamber formed between the balloons 130, 132. In one example, when inflated or expanded, the balloons 130, 132 can be configured to limit or substantially inhibit the transmission of pressure wave energy through the balloons. In this way, as Figure 4 As shown, the energy is substantially contained within the resulting propagation chamber and treatment site.

[0029] refer to Figure 5Another embodiment of a catheter system for treating calcified plaque in a subject's body is generally indicated by reference numeral 210. Similar to the first catheter system 10, the present catheter system 210 is configured to deliver longitudinal pressure waves LPW to the calcified plaque. The longitudinal pressure waves LPW change or destroy the calcified plaque. The catheter body 212, the pressure wave generator (not shown), the control unit (not shown), and the aspirator (not shown) can be similar or identical to the corresponding catheter body 12, the longitudinal pressure wave generator 14, and the controller 16.

[0030] The catheter system 210 further includes an inflatable or expandable balloon 230 (e.g., an angioplasty balloon) configured to direct wave energy toward the treatment site. The balloon 230 defines an interior configured to be filled with a fluid medium. The distal portion of the catheter body 212 is communicated with the fluid medium in the balloon 230 so that the wave energy from the catheter body 212 propagates through the balloon and reaches the treatment site. The distal and / or proximal ends of the balloon 230 can be configured to limit or substantially inhibit the transmission of pressure wave energy through the balloon so that the wave energy is contained within the balloon. The balloon 230 can be configured to apply a suitable pressure to the calcified plaque while the wave energy is being treated for angioplasty. Alternatively, the balloon 230 can be configured to apply a nominal pressure that is not suitable for angioplasty but sufficient to enable the wave energy to be transmitted to the calcified plaque.

[0031] In an exemplary treatment method using any one of the catheter systems 10, 110, 210, the catheter body 12, 112, 212 is inserted into the body of the subject and traverses to the treatment site. Then, using any one of the catheter systems 110, 210, the balloons 130, 132, 230 are inflated. The wave generator 14 is then activated to deliver longitudinal wave energy to the distal portion and calcified plaque of the catheter body 12, 112, 212. The wave energy changes or destroys the calcified plaque. For example, the energy may rupture the calcified plaque (e.g., cause microruptures). After treatment with the catheter system 10, 110, 210, in one example, the catheter body 12, 112, 212 can be withdrawn, and subsequent treatment (e.g., angioplasty and / or plaque removal and / or drug therapy) can be performed.

[0032] refer to Figures 6 to 9, another embodiment of the catheter system for treating calcified plaque in the body of a subject is generally represented by reference numeral 310. The catheter system 310 includes a catheter body 312, which has a proximal portion and a distal portion and a longitudinal axis extending therebetween. The catheter body 312 is designed and constructed to be inserted percutaneously into the subject's blood vessel to deliver the distal portion of the catheter body to the treatment site including the calcified plaque. As a non-limiting example, the catheter body 12 can have a length from about 150mm to about 400mm, and a diameter from about 0.014 inches (0.3556mm) to about 0.120 inches (3.048mm). The catheter body 312 can be appropriately flexible (e.g., coiled shaft) so that the body can reach the treatment site through a tortuous path. As described below, in one example, the catheter 310 is suitable for use as a guide wire for delivering another treatment catheter to the treatment site. In other examples, the catheter 310 may not be used as a guide wire.

[0033] The catheter 310 includes a selectively deployable treatment member 320 located at a distal end portion of the catheter body and configured to modify or disrupt calcified plaque. Figure 8 and Fig. 9 The therapeutic member is shown in the expanded configuration, and Figure 6 and Figure 7 The treatment member 320 is shown in a non-deployed configuration. In one example, the treatment member 320 includes a body 322 and a plurality of fins 324 that protrude radially outward relative to the body 322 in the deployed configuration and are generally flush with or recessed relative to the body in the non-deployed configuration. The fins 324 are spaced circumferentially from each other around the body 322. In one example, the body 322 and the fins 324 are integrally formed as a one-piece component, wherein the fins are coupled to the body by living hinges, thereby enabling the fins to pivot radially outward from the body. Figure 6 As shown, the treatment member 320 can be formed from a metal tube (eg, a hypotube) with the fins formed from circumferential slots 328 in the tube. The treatment member can have other configurations and designs and can be formed in other ways.

[0034] refer to Figure 7 and Fig. 9, an actuator 340 operable by a user selectively configures the treatment member 320 between a deployed configuration and a non-deployed configuration. In the illustrated embodiment, the actuator 340 includes a shaft 344 extending along and within the treatment member 320 and the catheter body 312. The shaft 344 is capable of longitudinal movement within and relative to the treatment member 320. A head 346 at a distal end portion of the shaft 344 is capable of engaging proximal and distal internal shoulders or stops 350, 352 within the treatment member 320. In the illustrated embodiment, the head 346 is threadedly coupled within the treatment member 320, and the shaft 344 and head are axially rotatable relative to the treatment member 320 and the body 312. Rotation of the shaft 344 and head 346 in a first direction imparts longitudinal movement of the head and shaft in a proximal direction. Rotation of the shaft 344 and head 346 in a second direction imparts longitudinal movement of the head and shaft in a distal direction.

[0035] Proximal movement of the actuator 340 relative to the treatment member 320 (e.g., by rotating the shaft 344) causes the head 346 to engage the proximal shoulder 350, thereby applying a compressive force to the treatment member and configuring the treatment member from the non-deployed configuration to the deployed configuration. In other words, the compressive force causes the treatment member 320 to contract longitudinally and the fins to bend about the living hinges, such that the fins 324 protrude radially outward in the deployed configuration. Distal movement of the actuator 340 relative to the treatment member 320 (e.g., by rotating the shaft 344) causes the head 346 to engage the distal shoulder 352, thereby applying a tensile force to the treatment member and configuring the treatment member from the deployed configuration to the non-deployed configuration. In other words, the tensile force causes the treatment member to expand longitudinally and the fins to retract radially inward about the living hinges. A rotary-to-linear mechanism (e.g., a threaded connection) inhibits back-off, provides a mechanical advantage in applying proximal and distal forces to the respective shoulders 350, 352, and enables a user to select the amount of radial displacement of the fin 324 and / or the force applied by the fin to the calcified plaque.

[0036] In one embodiment, the catheter system 310 is designed and constructed as a guidewire. After the guidewire 310 is delivered to the treatment site and the treatment member 320 is in a non-deployed configuration, the user operates the actuator 340 to deploy the treatment member. As an example, the user can manually rotate the shaft 344 using a control handle or some other device external to the subject's body. When the treatment member 320 is deployed, the fins 324 move radially outward and engage the calcified plaque. The fins 324 apply radial compression forces to the calcified plaque to change or destroy the plaque. After treatment with the treatment member 320, the user operates the actuator 340 to retract the fins 324 radially inward to the non-deployed configuration. The guidewire 310 can remain within the body lumen for receiving another catheter system, such as for, for example, angioplasty or plaque resection.

[0037] The present invention may be further described by reference to the following numbered paragraphs: 1.1. A catheter system for treating calcified plaque in a subject's body, the catheter system comprising: a catheter body having opposed proximal and distal end portions and a longitudinal axis extending therebetween, wherein the catheter body is configured to be percutaneously inserted into a body of a subject and delivered to a treatment site having calcified plaque; and a longitudinal pressure wave generator configured to generate a longitudinal pressure wave, wherein the longitudinal pressure wave generator is connectable to a proximal portion of the catheter body so that the generated longitudinal pressure wave can be delivered to the catheter body, The catheter body is configured to enable a longitudinal pressure wave from a longitudinal pressure wave generator to propagate through the catheter body toward a distal end portion of the catheter body, and to deliver the propagated longitudinal pressure wave to a calcified plaque at a treatment site. 2. The catheter system of paragraph 1, wherein the catheter body includes an internal passage configured to receive a medium through which the longitudinal pressure wave propagates. 3. The catheter system of any of paragraphs 1 to 2, wherein the catheter body is configured to deliver the propagated longitudinal pressure wave through the distal end of the catheter body. 4. The catheter system of any of paragraphs 1 to 3, wherein the catheter body includes an internal passage filled with a medium through which the longitudinal pressure waves propagate. 5. The catheter system of any of paragraphs 1 to 4, further comprising an aspirator configured to remove debris dislodged from the treatment site during treatment. 6. The catheter system as described in any of paragraphs 1 to 5, further comprising at least one barrier at the distal portion of the catheter body, wherein the at least one barrier is configured to engage a wall of a body cavity in which a treatment site is provided to direct the longitudinal pressure wave toward the calcified plaque. 7. The catheter system of paragraph 6, wherein the at least one barrier comprises an expandable balloon. 8. The catheter system of paragraph 6, wherein the at least one barrier comprises two barriers. 9. The catheter system of paragraph 8, wherein the two barriers are spaced apart from one another such that one of the barriers is a proximal barrier and the other is a distal barrier. 10. The catheter system of paragraph 9, further comprising an extension shaft extending distally outwardly from the distal end portion of the catheter body, wherein the distal barrier is coupled to the extension shaft. 11. The catheter system of any of paragraphs 8 to 10, wherein the two barriers are expandable balloons. 12. The catheter system of paragraph 6, wherein the at least one barrier is configured to limit transmission of longitudinal pressure waves through the at least one barrier. 13. The catheter system as described in any of paragraphs 1 to 12 further includes an inflatable balloon defining an interior configured to receive a fluid, wherein the interior of the balloon is configured to receive a longitudinal pressure wave from the catheter body and guide the longitudinal pressure wave to the calcified plaque at the treatment site. 14. A method of treating calcified plaque at a treatment site within a subject's body, the method comprising: delivering a catheter body of the catheter system to a treatment site such that a distal portion of the catheter body is adjacent to the calcified plaque; propagating a longitudinal pressure wave from a proximal portion of the catheter body through the catheter body toward a distal portion of the catheter body; and A longitudinal pressure wave is delivered from the distal portion of the catheter body to the calcified plaque. 15. The method of paragraph 14, further comprising inflating a balloon at a distal end portion of a catheter body after said delivering the catheter body and before said propagating the longitudinal pressure wave. 16. The method of any of paragraphs 14 to 15, further comprising propagating a longitudinal pressure wave within an inflated balloon prior to delivering the longitudinal pressure wave to the calcified plaque. 17. A catheter system for treating calcified plaque in a body of a subject, the catheter system comprising: a catheter body having opposed proximal and distal end portions and a longitudinal axis extending therebetween, wherein the catheter body is configured to be percutaneously inserted into a body of a subject and delivered to a treatment site having calcified plaque; a treatment member at a distal portion of the catheter body, the treatment member comprising a treatment member body and a plurality of fins coupled to the treatment member body, wherein the treatment member is selectively configurable between a non-deployed configuration in which the fins are generally flush with the treatment member body and a deployed configuration in which the fins protrude radially outward from the treatment member body; and An actuator is configured to enable a user to deploy the therapeutic member between a non-deployed configuration and a deployed configuration. 18. The catheter system of paragraph 17, wherein the treatment member body and the fins are integrally formed as a one-piece component, wherein the fins are coupled to the treatment member by a living hinge. 19. The catheter system of any of paragraphs 17-18, wherein the actuator is configured to be longitudinally movable relative to the treatment member to selectively apply a compressive force to the treatment member to configure the treatment member in the expanded configuration. 20. The catheter system of any of paragraphs 17 to 19, wherein the actuator is threadably coupled to the treatment member.

[0038] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, according to examples, certain actions or events of any process or method described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., all described actions or events may not be necessary to implement these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0039] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0040] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Accordingly, the term "processor" as used herein may refer to any of the above structures or any other physical structures suitable for implementing the described techniques. In addition, these techniques may be fully implemented in one or more circuits or logic elements.

Claims

1. A catheter system (10, 110, 210) for treating calcified plaque in a subject's body, the catheter system (10, 110, 210) comprising: a catheter body (12, 112, 212) having opposing proximal and distal portions and a longitudinal axis extending therebetween, wherein the catheter body (12, 112, 212) is configured to be percutaneously inserted into the body of the subject and delivered to a treatment site having calcified plaque; and a longitudinal pressure wave generator (14) configured to generate a longitudinal pressure wave (LPW), wherein the longitudinal pressure wave generator (14) is connectable to a proximal portion of the catheter body (12, 112, 212) so as to enable the generated longitudinal pressure wave (LPW) to be delivered to the catheter body (12, 112, 212), Wherein, the catheter body (12, 112, 212) is configured to enable the longitudinal pressure wave (LPW) from the longitudinal pressure wave generator (14) to propagate through the catheter body toward the distal portion of the catheter body (12, 112, 212), and to deliver the propagated longitudinal pressure wave (LPW) to the calcified plaque at the treatment site.

2. The catheter system (10, 110, 210) of claim 1, wherein: The catheter body (12, 112, 212) includes an internal passage configured to receive a medium through which the longitudinal pressure wave (LPW) propagates.

3. The catheter system (10, 110, 210) according to any one of claims 1 to 2, wherein: The catheter body (12, 112, 212) is configured to deliver a propagated longitudinal pressure wave (LPW) through a distal end of the catheter body (12, 112, 212).

4. The catheter system (10, 110, 210) according to any one of claims 2 to 3, wherein: The catheter body (12, 112, 212) includes an internal passage filled with a medium through which the longitudinal pressure wave (LPW) propagates.

5. The catheter system (10, 110, 210) according to any one of claims 1 to 4, further comprising: An aspirator (20) is configured to remove debris dislodged from the treatment site during treatment.

6. The catheter system (10, 110, 210) according to any one of claims 1 to 5, further comprising: At least one barrier (130, 132) at a distal portion of the catheter body (12, 112, 212), wherein the at least one barrier (130, 132) is configured to engage a wall of a body lumen in which the treatment site is disposed to direct the longitudinal pressure wave (LPW) toward the calcified plaque.

7. The catheter system (10, 110, 210) of claim 6, wherein: The at least one barrier (130, 132) comprises an expandable balloon.

8. The catheter system (10, 110, 210) of claim 6, wherein: The at least one barrier (130, 132) includes two barriers.

9. The catheter system (10, 110, 210) of claim 8, wherein: The two barriers (130, 132) are spaced apart from each other such that one of the barriers is a proximal barrier (130) and the other is a distal barrier (132).

10. The catheter system (10, 110, 210) of claim 9, further comprising: An extension shaft (1360) extends distally and outwardly from a distal end portion of the catheter body (12, 112, 212), wherein the distal barrier (132) is coupled to the extension shaft (136).

11. The catheter system (10, 110, 210) according to any one of claims 8 to 10, wherein: The two barriers (130, 132) are expandable balloons.

12. The catheter system (10, 110, 210) of claim 6, wherein: The at least one barrier (130, 132) is configured to limit transmission of the longitudinal pressure wave (LPW) through the at least one barrier.

13. The catheter system (10, 110, 210) of any one of claims 1 to 4, further comprising: An inflatable balloon (230) defines an interior configured to receive a fluid, wherein the interior of the balloon (230) is configured to receive a longitudinal pressure wave (LPW) from the catheter body (12, 112, 212) and direct the longitudinal pressure wave (LPW) to the calcified plaque at the treatment site.

14. The catheter system (10, 110, 210) of claim 13, wherein: At least one of the distal end and the proximal end of the balloon (230) is configured to limit or substantially inhibit the longitudinal pressure wave (LPW) from being transmitted through the balloon such that the longitudinal pressure wave (LPW) is contained within the balloon (230).

15. The catheter system (10, 110, 210) according to any one of claims 13 to 14, wherein: The balloon (230) is configured to apply appropriate pressure to the calcified plaque to perform angioplasty treatment while guiding the longitudinal pressure wave (LPW) to the calcified plaque at the treatment site.

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