WO2024175335A1

WO2024175335A1 - Electromechanical endoflator for balloon catheter

Info

Publication number: WO2024175335A1
Application number: PCT/EP2024/052674
Authority: WO
Inventors: James David Cezo; Marco Lai
Original assignee: Koninklijke Philips N.V.
Priority date: 2023-02-20
Filing date: 2024-02-04
Publication date: 2024-08-29

Abstract

A device is provided for transiently or cyclically inflating a balloon (140) of a balloon catheter (130). The device includes a processor, an electrical power source in communication with the processor, and an electromechanical actuator 170 in electrical communication with the electrical power source. The electromechanical actuator is configured to act on a fluid disposed within the balloon catheter, such that a transient or cyclic change in the current or voltage of the electrical power source causes a transient or cyclic change in a pressure of the fluid.

Description

ELECTROMECHANICAL ENDOFLATOR FOR BALLOON CATHETER

TECHNICAL FIELD

[0001] The subject matter described herein relates to systems, devices, and methods for shocking or vibrating the balloon of a balloon catheter. The electromechanical endoflator disclosed herein has particular but not exclusive utility for fracturing of calcified vascular stenoses inside of a blood vessel.

BACKGROUND

[0002] Many individuals (especially elderly individuals) suffer from progressively enlarging vascular calcium mineral deposits. Such vascular calcification can cause symptoms such as compromised vascular integrity, vascular stenoses, hypertension, enlargement of the heart, ischemia, and congestive heart failure. The severity and extent of mineralization are strong predictors for morbidity and mortality. Vascular calcification may be recognized as a pathobiological process similar in some ways to bone formation. Vascular (e.g., arterial and venous) calcifications can be a persistent problem when treating coronary or peripheral vessels.

[0003] Many types of stenosis can be treated at least partially with balloon angioplasty to dilate the vessel at the location of the stenosis. In some cases, a stent may also be implanted at the dilated location in order to preserve the dilation. However, because of the stiff, mineral nature of vascular calcifications, angioplasty balloons may not effectively dilate a vessel at the site of a calcification and may even burst when taken to high pressure at these calcifications.

[0004] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound. SUMMARY

[0005] Disclosed is an electromechanical endoflator. The electromechanical endoflator disclosed herein has particular, but not exclusive, utility for fracturing calcified vascular stenoses. The electromechanical endoflator attaches to a balloon catheter that can be inserted into the vasculature of a patient. When the balloon is positioned at a calcified (hardened) location within a vessel, the electromechanical endoflator can slowly expand the balloon until it is in contact with the vessel walls. The electromechanical endoflator can then briefly and rapidly inflate the balloon by a small additional amount, to generate a hydraulic shock that can fracture the calcification. This expansion can be singular or cyclic, depending on the needs of the situation.

[0006] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. One general aspect includes a device for transiently or cyclically inflating a balloon of a balloon catheter. The device also includes a processor; an electrical power source in communication with the processor; and an electromechanical actuator in electrical communication with the electrical power source and configured to act on a fluid disposed within the balloon catheter, such that a transient or cyclic change in the current or voltage of the electrical power source causes a transient or cyclic change in a pressure of the fluid. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0007] Implementations may include one or more of the following features. In some aspects, the transient or cyclic change in the pressure of the fluid is configured to cause a transient or cyclic change in a diameter of the balloon. In some aspects, when the balloon is disposed within a vessel of a patient comprising a calcified stenosis, the transient or cyclic change in the pressure of the fluid is configured to deliver a hydraulic shock or vibration to the calcified stenosis. In some aspects, the hydraulic shock or vibration is configured to cause a fracturing of the calcified stenosis. In some aspects, a manipulation of the manual actuator causes a static change in the pressure of the fluid. In some aspects, the device may include a pressure gauge in fluid communication with the fluid and configured to display the pressure of the fluid. In some aspects, the device may include the balloon catheter. In some aspects, a catheter of the balloon catheter may include: a metal hypotube that may include a plurality of cuts, and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube. In some aspects, the balloon of the balloon catheter may include a compliant balloon, a non-compliant balloon, a cutting balloon, a scoring balloon, or other suitable type of balloon. In some aspects, the electromechanical actuator may include a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator.

Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0008] One general aspect includes a method for fracturing a calcified stenosis of a vessel of a patient. The method includes providing a manual actuator configured to statically alter a pressure of a fluid within a balloon catheter disposed within the vessel of the patient proximate to the calcified stenosis, where a diameter of a balloon of the balloon catheter is increased such that the balloon is in circumferential contact with the calcified stenosis; with a processor, activating an electrical power source to produce a transient or cyclic change in a current or voltage of the electrical power source; and with an electromechanical actuator, in response to the transient or cyclic change in current or voltage, producing a transient or cyclic change in the pressure of the fluid, such that the balloon delivers a hydraulic shock or vibration to the calcified stenosis to fracture the calcified stenosis. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0009] Implementations may include one or more of the following features. In some aspects, the method may include, with a pressure gauge, measuring and reporting the pressure of the fluid. In some aspects, a catheter of the balloon catheter may include: a metal hypotube that may include a plurality of cuts, and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube. In some aspects, the balloon of the balloon catheter may include a compliant balloon, a non-compliant balloon, or a cutting balloon. In some aspects, the electromechanical actuator may include a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer- accessible medium.

[0010] One general aspect includes a system for fracturing a calcified stenosis of a vessel of a patient. A balloon catheter may include: a catheter configured for insertion into the vessel of the patient, and a balloon in fluid communication with the catheter and configured for insertion into the calcified stenosis. The system also includes a manual actuator configured to statically alter a pressure of a fluid within the balloon catheter when the balloon is positioned proximate to the calcified stenosis such that a diameter of the balloon is configured to be increased and the balloon is configured to be in circumferential contact with the calcified stenosis; a processor; an electrical power source in communication with the processor; and an electromechanical actuator in electrical communication with the electrical power source and configured to act on a fluid disposed within the balloon catheter, such that a transient or cyclic change in the current or voltage of the electrical power source causes a transient or cyclic change in the pressure of the fluid, where the transient or cyclic change in the pressure of the fluid is configured to cause the balloon to deliver a hydraulic shock or vibration to the calcified stenosis. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0011] Implementations may include one or more of the following features. In some aspects, the system may include a pressure gauge in fluid communication with the fluid and configured to measure and report the pressure of the fluid. In some aspects, the catheter may include a metal hypotube, which may include a plurality of cuts, and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube. In some aspects, the balloon may include a compliant balloon, a non-compliant balloon, or a cutting balloon. In some aspects, the electromechanical actuator may include a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer- accessible medium.

[0012] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the electromechanical endoflator, as defined in the claims, is provided in the following written description of various embodiments of the disclosure and illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0014] Figure l is a schematic, diagrammatic representation of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0015] Figure l is a diagrammatic, perspective view of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0016] Figure 3A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0017] Figure 3B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0018] Figure 3C is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0019] Figure 4A is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0020] Figure 4B is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0021] Figure 5A is an example pressure vs. time graph of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0022] Figure 5B is an example pressure vs. time graph of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0023] Figure 6A is an example pressure vs. time graph of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. [0024] Figure 6B is an example pressure vs. time graph of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0025] Figure 7 is a schematic, side cross-sectional view of an example catheter body 135, in accordance with at least one embodiment of the present disclosure.

[0026] Figure 8A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0027] Figure 8B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0028] Figure 9A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0029] Figure 9B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0030] Figure 10A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0031] Figure 10B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0032] Figure 11A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0033] Figure 11B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0034] Figure 12 shows a flow diagram of an example calcified stenosis fracturing method, according to at least one embodiment of the present disclosure.

[0035] Figure 13 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. [0036] Figure 14 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0037] Figure 15 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0038] Figure 16 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0039] Figure 17 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure.

[0040] Figure 18 is a schematic diagram of a processor circuit, according to embodiments of the present disclosure.

DETAILED DESCRIPTION

[0041] The present disclosure provides an electromechanical endoflator for a balloon catheter. The electromechanical endoflator is configured to transiently vary the balloon pressure to subject vascular calcifications to fatigue fracture, and thus achieve dilation of the stenosis. Calcifications tend to be well rooted into soft tissue, or even completely encapsulated by soft tissue, such that fracturing the calcification does not generally release the calcified material into the bloodstream. The fracturing process may for example be analogous to breaking up a bag of frozen-together ice cubes, without opening the bag.

[0042] In some embodiments, the electromechanical endoflator includes two actuators coupled to a fluid chamber, or to multiple fluid chambers in fluid communication with one another. One actuator may for example include a manual plunger which the user can move translationally or rotationally for the purposes of reducing the chamber’s volume and therefore increase the static pressure of the system. The second actuator may for example be electromechanical, such that when it is supplied with a current, it will expand within the chamber to reduce the chamber’s volume and therefore increase the pressure of the system. The stimulating current of the electromechanical actuator can be varied to produce a sudden hydraulic shock in the fluid chamber, or to produce repeated shocks, or to produce a timevarying (e.g., sinusoidal) pressure. Hydraulic shock may for example be analogous to “water hammer” in a plumbing system, where a moving, relatively incompressible fluid comes to a sudden stop, resulting in a sudden pressure change or series of sudden pressure changes.

[0043] The endoflator is designed to connect to an angioplasty balloon catheter which will be in fluid communication with the fluid chamber(s) of the endoflator. The corresponding static or transient pressures produced by the endoflator can then be transmitted by the angioplasty balloon catheter to the angioplasty balloon on or near the catheter’s distal end. The pressure can then act upon the tissues surrounding the angioplasty balloon, for the purposes of treating calcified or otherwise resistant stenoses in the vasculature.

[0044] In some embodiments the electromechanical actuator is independent from the mechanical endoflator, and both connect to an angioplasty balloon catheter via a manifold. In some embodiments, the endoflator is equipped with sensors to detect pressure and or volumetric changes in the fluid chamber. These data can be relayed to the user via analog gauges or digitized on a user interface. These data may be interpreted by the user to determine the treatment success or completion. [0045] The present disclosure aids substantially in the treatment of calcified stenoses, by improving a clinician’s ability to deliver high pressures to the calcification. In fluid communication with a balloon catheter in the electromechanical endoflator disclosed herein provides a practical ability to deliver hydraulic shocks or vibrations to a stenosis via the angioplasty balloon, while minimizing the risk of rupturing the balloon. This improved angioplasty technique transforms a solid calcification into a number of tissue-bound fragments, without the normally routine need to ablate or cut the calcified tissue. This unconventional approach improves the functioning of the balloon angioplasty system, by permitting transient pressures that may in some cases be higher than the maximum static pressure the balloon can withstand.

[0046] The electromechanical endoflator may be controlled manually, or through an automated process at least partially viewable on a display and executing on a processor that accepts user inputs from a keyboard, mouse, or touchscreen interface. In that regard, the control process performs certain specific operations in response to different inputs or selections made at different times. Certain structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity. [0047] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the electromechanical endoflator. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter. [0048] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0049] Figure l is a schematic, diagrammatic representation of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. The balloon angioplasty system 100 includes a console or workstation 110, an electromechanical endoflator 120, and a balloon catheter 130. In an example, the console 110 includes a housing 118 that encloses a processor circuit 112 in communication with an electrical power source (e.g., a current source and/or voltage source) 114 and a display 116. In an example, the electromechanical endoflator 120 includes a housing 190 and a manual actuator 160 that permits a clinician to increase the static pressure of a fluid chamber 180 that is in fluid communication with the balloon catheter 130 via a fluid line 195. The electromechanical endoflator 120 also includes an electromechanical actuator 170 which receives power from the electrical power source 114 via a cable 150. Similar to the manual actuator 160, the electromechanical actuator 170 can provide a transient pressure, additive to the static pressure of the fluid chamber 180 and thus communicated to the balloon catheter 130 via the fluid line 195. In some instances, the fluid line 195 and the balloon catheter 130 are separate components. In some instances, the fluid line 195 and the balloon catheter 130 are the same component. For example, the fluid line 195 can be a portion of a length of the balloon catheter 130 (e.g., a portion of a length of the catheter body 135).

[0050] In an example, the balloon catheter 130 includes a catheter body or flexible elongate member 135 in fluid communication with a balloon 140.

[0051] Before continuing, it should be noted that the examples described above are provided for purposes of illustration and are not intended to be limiting. Other devices and/or device configurations may be utilized to carry out the operations described herein.

[0052] Figure l is a diagrammatic, perspective view of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the console 110, console housing 118, electrical cable 150, electromechanical endoflator 120, endoflator housing 190, manual actuator or plunger 160, electromechanical actuator 170, fluid chamber 180, fluid line 195, balloon catheter 130, and balloon 140.

[0053] The manual actuator or plunger 160 can be operated by a clinician to increase or decrease the static pressure in the fluid chamber 180. In an example, depressing the plunger 160 increases the static pressure, and withdrawing the plunger 160 decreases the static pressure. Other types of manual actuator 160 ay be used instead or in addition, and the manual actuator 160 may include a screw or lock 260 to prevent the manual actuator 160 from moving, and thus to prevent unwanted changes in the static pressure of the fluid chamber 180. [0054] The electromechanical actuator 170 may for example be a piston, a solenoid, a block of piezoelectric material, or otherwise. When the electromechanical actuator 170 receives transient or time-varying power through the cable 150, the electromechanical actuator 170 temporarily expands or advances such that the volume of a transient pressure chamber 210 is increased, and thus a transient pressure is generated that is additive to the static pressure of the fluid chamber 180. The transient pressure chamber 210 is in fluid communication with the fluid chamber 180, which is in fluid communication with the balloon catheter 130 via the fluid line 195. At any given moment, the total pressure in the fluid chamber 180 (e.g., the sum of the static pressure and transient pressure) may be shown on a gauge 220, which may for example be an analog, digital gauge, or graphical. Depending on the implementation, the transient pressure may be shown on the display 116 instead or in addition, or may be represented by an audio tone, a haptic feedback such as a vibration, a color, or otherwise.

[0055] The balloon catheter 130 includes a catheter body 135, which includes a portion 234 that remains outside the patient’s body, and a portion 236 that is inserted into the patient’s vasculature or other body lumen. A proximal portion of the balloon catheter 130 is coupled (e.g., removably coupled) to a distal portion of the electromechanical endoflator 120. A distal portion of the balloon catheter 130 (e.g., a distal portion of the catheter body 135) includes a tip assembly 240 and a balloon 140. The static diameter of the balloon 140 is a function of the static pressure. However, the balloon can also experience a transient expansion, contraction, or vibration based on changes in the transient pressure. The frequency or duty cycle of a vibration may for example be between 10 and 100 Hz, although in some embodiments it may be between 1 and 10,000 Hz.

[0056] Figure 3A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, piezoelectric electromechanical actuator 170, and catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140. A proximal portion of the catheter body 135 is coupled (e.g., removably coupled) to the distal portion of the electromechanical endoflator 120 to establish fluid communication between the electromechanical endoflator 120 and the balloon catheter 130. A fluid 310 is contained within the fluid chamber 180, transient pressure chamber 210, catheter lumen 330, and balloon 140. The fluid 310 may for example be a mixture of saline solution and an x-ray or ultrasound contrast dye, in order to make the balloon 140 visible in an X-ray or ultrasound angiography image. An increase or decrease in the pressure of the fluid 310 causes the fluid 310 to flow into or out of an interior volume 340 of the balloon 140 via one or more inflation ports 345.

[0057] The fluid chamber 180 and the transient pressure chamber 210 can be two subvolumes of an individual volume (e.g., two portions of the individual volume). For example, the housing 190 of the electromechanical endoflator 120 can define the individual volume, which includes the fluid chamber 180 and the transient pressure chamber 210. For example, the fluid chamber 180 and the transient pressure chamber 210 are in fluid communication with one another within the housing 190 of the electromechanical endoflator 120.

[0058] In the example shown in Figure 3 A, the manual actuator 160 is depressed by a distance Pl, while the electromechanical actuator 170 has a thickness Tl, which results in a volume V3 A and a pressure P3 A of the fluid 310, and thus a diameter DI for the balloon 140. It is noted that, depending on the magnitude of the pressure change and the material from which the balloon is made, this diameter change can be quite small (e.g., less than one millimeter in some cases), while still producing the desirable effects described herein.

[0059] Figure 3B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, piezoelectric electromechanical actuator 170, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0060] In the example shown in Figure 3B, the manual actuator 160 is depressed by a distance P2, which is larger than the distance Pl of Figure 3 A, while the electromechanical actuator 170 has the same thickness Tl . Since the fluid 310 is approximately incompressible, the resulting volume V3B of the fluid 310 must be approximately the same as the volume V3A of Figure 1, while the pressure P3B (e.g., the static pressure) of the fluid 310 may increase proportionally with the difference between P2 and Pl . In order to keep the volume constant, the balloon 140 expands to a diameter D2, larger than the diameter DI of Figure 3 A, through flow of the fluid 310 into the balloon interior 340 via the inflation ports 345.

[0061] Figure 3C is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 170, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0062] In the example shown in Figure 3C, the manual actuator 160 is still depressed by a distance P2, but the piezoelectric electromechanical actuator 170 has (e.g., under the influence of a voltage) expanded to a thickness T2, which is larger than the thickness T1 of Figures 3 A and 3B. Since the fluid 310 is approximately incompressible, the resulting volume V3C of the fluid 310 must be approximately the same as the volumes V3 A of Figure 3A and V3B of Figure 3B, while the pressure P3C of the fluid 310 may increase proportionally with the difference between T2 and Tl. In order to keep the volume constant, the balloon 140 expands to a diameter D3 (larger than the diameter D2 of Figure 3B), through flow of the fluid 310 into the balloon interior 340 via the inflation ports 345.

[0063] However, the thickness increase of the piezoelectric electromechanical actuator 170 is transient, such that when the voltage is removed, the thickness T2 may return to a baseline thickness Tl, and the pressure P3C may return to the static pressure P3B, through flow of the fluid 310 out of the balloon interior 340 and into the catheter interior 330 via the inflation ports 345. Thus, the balloon 140 may return to a diameter D2.

[0064] Figure 4A is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 4A, the balloon 140 is positioned inside/within a blood vessel (e.g., a lumen of the blood vessel) or other body lumen 410 (e.g., longitudinally co-located with, adjacent to, and/or otherwise proximate to a calcification 430 attached to the vessel wall 420 of the blood vessel or other body lumen 410). Because the calcification 410 has a hard, bony or mineral -like consistency, simply expanding the balloon 140 (e.g., by increasing the static pressure via the manual actuator) may not dilate the vessel 410.

[0065] Figure 4B is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 4B, the balloon 140 is positioned inside/within a blood vessel (e.g., a lumen of the blood vessel) or other body lumen 410 (e.g., longitudinally co-located with, adjacent to, and/or otherwise proximate to a calcification attached to the vessel wall 420 of the blood vessel or other body lumen 410). After delivery of a transient or periodic (e.g., sinusoidal) pressure increase or “shock” delivered by the electromechanical endoflator, the calcification 430 of Figure 4A has been fractured (e.g., fatigue fractured) into a plurality of bound, calcified fragments 440. Because the calcified fragments 440 have a gravelly or sandy consistency, expanding the balloon 140 (e.g., by increasing the static pressure via the manual actuator) may now be sufficient to dilate the vessel 410 (e.g., for subsequent stenting).

[0066] Depending on the implementation, the balloon angioplasty system 100 with electromechanical endoflator may be used with custom angioplasty balloons specifically designed for use with the electromechanical endoflator, or may be used with any of a variety of off-the-shelf angioplasty balloon types, including compliant balloons, non-compliant balloons, cutting balloons, and otherwise

[0067] Figure 5A is an example pressure vs. time graph 510 of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. The Y-axis of the graph 510 shows pressure in atmospheres inside the endoflator (e.g., inside the fluid chamber 180 of Figures 1-3B), while the X-axis of the graph 510 shows time in seconds. Visible are an average or baseline or static pressure 530, and a time-variant (e.g., sinusoidal) pressure 520 having an amplitude A and a period P. In an example, the average or baseline or static pressure 530 is determined by a position of the manual actuator 160 (see Figs. 1-3B), while the amplitude A and period P of the time-variant pressure 520 are determined by the expansion and contraction of the piezoelectric electromechanical actuator 170 (see Figs. 1-3B) under the influence of the electrical power source 114 controlled by the processor circuit 112 (see Fig. 1). In an example, the console 110 (see Fig. 1) may include a user interface (whether analog or digital) to enable to user to select at least one of the amplitude A or the period P.

[0068] Figure 5B is an example pressure vs. time graph 540 of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. The Y-axis of the graph 540 shows pressure in atmospheres inside the balloon 140 (see Figures 1-3B), while the X-axis of the graph 540 shows time in seconds. Visible are an average or baseline or static pressure 560, and a timevariant (e.g., sinusoidal) pressure 550, which may for example have a similar period as the curve 520 of Figure 5 A, and may have a slightly smaller amplitude due to friction losses in the system. Because fluid takes a certain amount of time to travel, e.g., from the transient pressure chamber 210 to the balloon interior 340 (see Figs. 3A-3C), the curve 550 is lagged or time-shifted with respect to the curve 520 of Figure 5 A, by an amount AT. [0069] Figure 6A is an example pressure vs. time graph 610 of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. The Y-axis of the graph 610 shows pressure in atmospheres inside the endoflator (e.g., inside the fluid chamber 180 of Figures 1-3B), while the X-axis of the graph 610 shows time in seconds. Visible are an average or baseline or static pressure 630, and a transient pressure or shock pressure 520 having an amplitude A and a decay time DT. In an example, the average or baseline or static pressure 530 is determined by a position of the manual actuator 160 (see Figs. 1-3B), while the amplitude A and decay time DT of the transient or shock pressure 620 are determined by the expansion and contraction of the piezoelectric electromechanical actuator 170 (see Figs. 1-3B) under the influence of the electrical power source 114 controlled by the processor circuit 112 (see Fig. 1).

[0070] Figure 6B is an example pressure vs. time graph 640 of an example balloon angioplasty system with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. The Y-axis of the graph 640 shows pressure in atmospheres inside the balloon 140 (see Figures 1-3B), while the X-axis of the graph 640 shows time in seconds. Visible are an average or baseline or static pressure 660, and a transient pressure or shock pressure 650, which may for example have a similar decay time as the curve 620 of Figure 5 A, and may have a slightly smaller amplitude due to friction losses in the system. Because fluid takes a certain amount of time to travel, e.g., from the transient pressure chamber 210 to the balloon interior 340 (see Figs. 3A-3C), the curve 650 is lagged or time-shifted with respect to the curve 620 of Figure 6A, by an amount AT.

[0071] Figure 7 is a schematic, side cross-sectional view of an example catheter body 135, in accordance with at least one embodiment of the present disclosure. When the electromechanical actuator creates a transient or time-varying pressure wave through the system, pressure within the catheter lumen 330 of the catheter body 135 can increase both dramatically and rapidly. Thus, a catheter body 135 made only of polymer could potentially expand (leading to pressure losses) or even rupture (leading to leakage of the fluid). Thus, in the example shown in Figure 7, the catheter body 135 comprises a metal hypotube 710 that includes a plurality of cuts 720 (e.g., laser-cut spirals or mesh patterns) to render it flexible enough to navigate through tortuous vasculature, yet stiff enough to resist expansion or contraction when the internal pressure of the catheter lumen 330 changes suddenly. In order to prevent fluid leakage and render the catheter body 135 watertight, the catheter body 135 includes at least one of an inner polymer sealing layer 730 or an outer polymer sealing layer 740. In some embodiments, the outer polymer sealing layer 740 may also prevent the hypotube 710 and cuts 720 from coming into contact with vessel walls, thus reducing friction and improving the mobility of the catheter body 135 within tortuous vasculature. In other embodiments, the catheter body 135 is made from a stiff, non-compliant, or fiber-reinforced polymer to resist expansion and rupture, and does not include a metal hypotube 720.

[0072] Figure 8A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 870, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0073] In the example shown in Figure 8A, the electromechanical actuator 870 is an electrically, magnetically, or electromagnetically controlled piston or solenoid that includes a rod 872, a coil 874, and a pusher plate 876. The pusher plate 876 defines a thickness Cl for the electromechanical actuator 870, which results in a volume V8A and a pressure P8A of the fluid 310, and thus a diameter D2 for the balloon 140.

[0074] Figure 8B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 870, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0075] In the example shown in Figure 8B, the electromechanical actuator 870 is an electrically controlled piston or solenoid that includes a rod 872, a coil 874, and a pusher plate 876. Under the influence of a voltage or current, the pusher plate 876 has moved forward to define a thickness C2 for the electromechanical actuator 870, which results in a volume V8B and a pressure P8B of the fluid 310, and thus a diameter D3 for the balloon 140. [0076] Figure 9A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 970, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0077] In the example shown in Figure 9A, the electromechanical actuator 970 is piston containing a photoreactive liquid 974 capable of expanding to push a pusher plate 876. The pusher plate 876 defines a thickness Cl for the electromechanical actuator 870, which results in a volume V9A and a pressure P9A of the fluid 310, and thus a diameter D2 for the balloon 140.

[0078] Figure 9B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 970, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0079] In the example shown in Figure 9B, a light source 972 emits light that ignites or otherwise triggers a chemical reaction 978 in the photoreactive fluid 947, thus moving the plate 876 forward to define a thickness C2 for the electromechanical actuator 970, which results in a volume V9B and a pressure P9B of the fluid 310, and thus a diameter D3 for the balloon 140. The light source 972 can be in communication with the electromechanical endoflator 120. For example, the light source 972 can be a component of the console 110 (Fig. 1) or the electromechanical endoflator 120, or separate from the console 110 and the electromechanical endoflator 120. The light source 972 can be in communication with the console 110 and/or the electromechanical endoflator 120. In some instances, the processor circuit 112 and/or the electrical power source 114 can output a signal received by the light source 972 to activate the light source 972 to emit the light.

[0080] Figure 10A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 1070, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0081] In the example shown in Figure 10A, the fluid 310 is a photoreactive liquid. The fluid 310 has a volume V8A and a pressure P8A, yielding a diameter D2 for the balloon 140. [0082] Figure 10B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 1070, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0083] In the example shown in Figure 10B, the electromechanical actuator 870 is simply the transient pressure chamber 210. As similarly described above, the light source 972 emits light that ignites or otherwise triggers the chemical reaction 978 in the fluid 310 within the transient pressure chamber 210, thus creating a local increase in the volume of the fluid 310. Since the fluid 310 is approximately incompressible, this results in a volume V8B and a pressure P8B of the fluid 310, and thus a diameter D3 for the balloon 140.

[0084] Figure 11A is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 170, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0085] In the example shown in Figure 11 A, the electromechanical actuator 170 is piezoelectric electromechanical actuator 170, with a default or resting thickness of Tl, resulting in a volume VI 1 A and pressure Pl 1 A for the fluid 310, resulting in a diameter D2 for the balloon 140.

[0086] However, unlike in Figure 3 A, the electromechanical actuator 170 and transient pressure chamber 210 are physically separate from the manual actuator 160 and fluid chamber 180, and are connected by a Y-connector 1110. For example, the fluid chamber 180 and the transient pressure chamber 210 are physically distinct volumes. In some aspects, the fluid chamber 180 and the transient pressure chamber 210 do not share the same housing and are not in fluid communication with one another within the same housing. The housing including the fluid chamber 180 defines the volume of the fluid chamber 180 and a separate housing including the transient pressure chamber 210 defines the separate volume of the transient pressure chamber 210. The fluid chamber 180 and the transient pressure chamber 210 can be in fluid communication with the balloon catheter 130 and/or with one another only via the Y-connector 1110. For example, a distal portion of the housing including the fluid chamber 180 is coupled (e.g., removably coupled) to one side of a proximal portion of the Y-connector 1110, a distal portion of the housing including the transient pressure chamber 210 is coupled (e.g., removably coupled) to another side of the proximal portion of the Y-connector 1110, and a proximal portion of the catheter body 135 is coupled (e.g., removably coupled) to the distal portion of the Y-connector 110. While a Y-connector (e.g., two input ports and one output port) is shown, it is understood that any coupling (e.g., any suitable quantity of input ports and any suitable quantity of output ports) can be used. This coupling and/or Y-connector 1110 can be referenced as a manifold in some instances.

[0087] Figure 11B is a schematic, diagrammatic view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator 120, in accordance with at least one embodiment of the present disclosure. Visible are the electromechanical endoflator 120, manual actuator 160, fluid chamber 180, transient pressure chamber 210, electromechanical actuator 170, catheter 130 including catheter body 135 (with catheter lumen 330) and balloon 140, fluid 310, balloon interior volume 340, and inflation ports 345. [0088] In the example shown in Figure 1 IB, the electromechanical actuator 170 is piezoelectric electromechanical actuator 170, an expanded (e.g., under the influence of a voltage) thickness of T2, resulting in a volume VI IB and pressure PUB for the fluid 310, resulting in a diameter D3 for the balloon 140. As in Figure 1 IB, the electromechanical actuator 170 and transient pressure chamber 210 are physically separate from the manual actuator 160 and fluid chamber 180, and are connected by the Y-connector 1110.

[0089] Figure 12 shows a flow diagram of an example calcified stenosis fracturing method 1200, according to at least one embodiment of the present disclosure. It is understood that the steps of method 1200 may be performed in a different order than shown in Figure 12, additional steps can be provided before, during, and after the steps, and/or some of the steps described can be replaced or eliminated in other embodiments. One or more of steps of the method 1200 can be carried out at least in part by one or more devices and/or systems described herein, such as components of the system 100, processor circuit 112, and/or processor circuit 1850.

[0090] In step 1210, the method 1200 includes inserting a balloon catheter into a blood vessel or other body lumen of a patient.

[0091] In step 1220, the method 1200 includes inflating the balloon using a manual endoflator.

[0092] In step 1230, the method 1200 includes, if the calcified stenosis cannot be fractured or dilated using the balloon and manual endoflator, deflating the balloon.

[0093] In step 1240, the method 1200 includes disconnecting the manual endoflator from the balloon catheter and connecting the balloon catheter to an electromechanical endoflator as described herein.

[0094] In step 1250, the method 1200 includes connecting the electromechanical endoflator to the console (e.g., by an electrical cable). [0095] In step 1260, the method 1200 includes inflating the balloon using the manual actuator of the electromechanical endoflator.

[0096] In step 1270, the method 1200 includes activating the electromechanical actuator of the electromechanical endoflator, in order to vibrate or shock the calcified stenosis and thus promote fracturing. In some cases, step 1270 may be performed multiple times.

[0097] In step 1280, the method 1200 includes performing additional therapy such as ablation or stenting, after the balloon and the electromechanical actuator have fractured the calcified stenosis. The method is now complete.

[0098] Flow diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, the logic of flow diagrams may be shown as sequential. However, similar logic could be parallel, massively parallel, object oriented, real-time, event- driven, cellular automaton, or otherwise, while accomplishing the same or similar functions. In order to perform the methods described herein, a processor may divide one or more of the steps described herein into a plurality of machine instructions and may execute these instructions at the rate of several hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors.

[0099] Figure 13 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 13, the balloon 140 is positioned inside/within a blood vessel (e.g., a lumen of the blood vessel) or other body lumen 410 (e.g., longitudinally co-located with, adjacent to, and/or otherwise proximate to a calcification or calcified stenosis 430 attached to the vessel wall 420 of the blood vessel or other body lumen 410).

[00100] Figure 14 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 14, the physician operates the manual actuator 160 to increase the static pressure within the catheter body 135 and balloon 140, to a desired pressure that is readable on a pressure gauge 220 and that inflates the balloon 140 to a desired diameter, such that at least a portion of the balloon 140 is in contact (e.g., circumferential contact) with the calcified stenosis 430. [00101] Figure 15 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 15, the clinician attaches the power cable 150 to a socket 1510 in the console 110. Also visible is an electromechanical endoflator activation button 295.

[00102] Figure 16 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 16, the clinician presses the electromechanical endoflator activation button 295, in order to shock or vibrate the balloon. [00103] Figure 17 is a diagrammatic, perspective view of at least a portion of an example balloon angioplasty system 100 with electromechanical endoflator, in accordance with at least one embodiment of the present disclosure. Visible are the catheter body 135, balloon 140, and tip assembly 240. In the example shown in Figure 17, the balloon 140 expands either transiently or periodically, thus resulting in shock or vibration 1700 of the calcified stenosis 430, thus fracturing the calcified stenosis 430.

[00104] Figure 18 is a schematic diagram of a processor circuit 1850, according to embodiments of the present disclosure. The processor circuit 1850 may be implemented in the system 100, the console 110, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method. As shown, the processor circuit 1850 may include a processor 1860, a memory 1864, and a communication module 1868. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[00105] The processor 1860 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor 1860 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1860 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. [00106] The memory 1864 may include a cache memory (e.g., a cache memory of the processor 1860), random access memory (RAM), magnetoresistive RAM (MRAM), readonly memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 1864 includes a non-transitory computer-readable medium. The memory 1864 may store instructions 1866. The instructions 1866 may include instructions that, when executed by the processor 1860, cause the processor 1860 to perform the operations described herein. Instructions 1866 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer- readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements. [00107] The communication module 1868 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 1850, and other processors or devices. In that regard, the communication module 1868 can be an input/output (I/O) device. In some instances, the communication module 1868 facilitates direct or indirect communication between various elements of the processor circuit 1850 and/or the system 100. The communication module 1868 may communicate within the processor circuit 1850 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I²C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.

[00108] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the pressure gauge) may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G/GSM (global system for mobiles) , 3G/UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

[00109] As will be readily appreciated by those having ordinary skill in the art after becoming familiar with the teachings herein, the electromechanical endoflator advantageously provides a capability to fracture calcified vascular stenoses (including those in peripheral and coronary veins and arteries), using either custom catheters or off-the-shelf non-compliant catheters, and using custom angioplasty balloons or off-the-shelf balloons, including compliant balloons, non-compliant balloons, cutting balloons, ant otherwise. [00110] A number of variations are possible on the examples and embodiments described above. For example, other types of electromechanical actuators, or other physical arrangements of mechanical and electromechanical actuators, could be employed than those described herein, without departing from the spirit of the present disclosure. The electromechanical endoflator could be used in other body lumens where there is clinical benefit in a hydraulic shock or vibration delivered through a balloon catheter. Different types of inflation fluids, consoles, processors, locking mechanisms, activation buttons or triggers, or pressure vs. time profiles may be used instead of or in addition to those described herein. [00111] Accordingly, the logical operations making up the embodiments of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may occur, or be performed or arranged, in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language.

[00112] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the electromechanical endoflator. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and/or” rather than “exclusive or.” The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[00113] The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the electromechanical endoflator as defined in the claims. Although various embodiments of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter. Still other embodiments are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

CLAIMS What is claimed is:

1. A device for transiently or cyclically inflating a balloon of a balloon catheter, the device comprising: a processor; an electrical power source in communication with the processor; and an electromechanical actuator in electrical communication with the electrical power source and configured to act on a fluid disposed within the balloon catheter, such that a transient or cyclic change in a current or voltage of the electrical power source causes a transient or cyclic change in a pressure of the fluid.

2. The device of claim 1, wherein the transient or cyclic change in the pressure of the fluid is configured to cause a transient or cyclic change in a diameter of the balloon.

3. The device of claim 1, wherein, when the balloon is disposed inside a vessel of a patient comprising a calcified stenosis, the transient or cyclic change in the pressure of the fluid is configured to deliver a hydraulic shock or vibration to the calcified stenosis.

4. The device of claim 3, wherein the hydraulic shock or vibration is configured to cause a fracturing of the calcified stenosis.

5. The device of claim 1, further comprising a manual actuator configured to act on the fluid disposed within the balloon catheter, wherein a manipulation of the manual actuator causes a static change in the pressure of the fluid.

6. The device of claim 5, further comprising a pressure gauge in fluid communication with the fluid and configured to display the pressure of the fluid.

7. The device of claim 1, further comprising the balloon catheter.

8. The device of claim 7, wherein a catheter of the balloon catheter comprises: a metal hypotube comprising a plurality of cuts; and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube.

9. The device of claim 7, wherein the balloon of the balloon catheter comprises a compliant balloon, a non-compliant balloon, or a cutting balloon.

10. The device of claim 1, wherein the electromechanical actuator comprises a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator.

11. A method for fracturing a calcified stenosis of a vessel of a patient, the method comprising: providing a manual actuator configured to statically alter a pressure of a fluid within a balloon catheter disposed inside the vessel of the patient proximate to the calcified stenosis, wherein a diameter of a balloon of the balloon catheter is increased such that the balloon is in circumferential contact with the calcified stenosis; with a processor, activating an electrical power source to produce a transient or cyclic change in a current or voltage of the electrical power source; and with an electromechanical actuator, in response to the transient or cyclic change in current or voltage, producing a transient or cyclic change in the pressure of the fluid, such that the balloon delivers a hydraulic shock or vibration to the calcified stenosis to fracture the calcified stenosis.

12. The method of claim 11, further comprising, with a pressure gauge, measuring and reporting the pressure of the fluid.

13. The method of claim 11, wherein a catheter of the balloon catheter comprises: a metal hypotube comprising a plurality of cuts; and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube.

14. The method of claim 11, wherein the balloon of the balloon catheter comprises a compliant balloon, a non-compliant balloon, or a cutting balloon.

15. The method of claim 11, wherein the electromechanical actuator comprises a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator.

16. A system for fracturing a calcified stenosis of a vessel of a patient, the system comprising: a balloon catheter comprising: a catheter configured for insertion into the vessel of the patient; and a balloon in fluid communication with the catheter and configured for insertion into the calcified stenosis; a manual actuator configured to statically alter a pressure of a fluid within the balloon catheter when the balloon is positioned proximate to the calcified stenosis such that a diameter of the balloon is configured to be increased and the balloon is configured to be in circumferential contact with the calcified stenosis; a processor; an electrical power source in communication with the processor; and an electromechanical actuator in electrical communication with the electrical power source and configured to act on a fluid disposed within the balloon catheter, such that a transient or cyclic change in a current or voltage of the electrical power source is configured to cause a transient or cyclic change in the pressure of the fluid, wherein the transient or cyclic change in the pressure of the fluid is configured to cause the balloon to deliver a hydraulic shock or vibration to the calcified stenosis.

17. The system of claim 16, further comprising a pressure gauge in fluid communication with the fluid and configured to measure and report the pressure of the fluid.

18. The system of claim 16, wherein the catheter comprises: a metal hypotube comprising a plurality of cuts; and at least one polymer sealing layer covering an inner or outer surface of the metal hypotube.

19. The system of claim 16, wherein the balloon comprises a compliant balloon, a non- compliant balloon, or a cutting balloon.

20. The system of claim 16, wherein the electromechanical actuator comprises a piezoelectric actuator, an electromagnetic actuator, or a photoreactive actuator.