Vascular pump

Abstract

An apparatus is described that includes a distal end and a proximal end and has a sensor attached to the distal end for receiving an electromagnetic frequency to control an impeller. The impeller moves fluid within a conduit based on the received electromagnetic frequency. Two or more chambers are positioned proximal and distal to the impeller. The impeller is positioned between the two or more chambers. The chambers preferably include a vibrating material or a piezoelectric material that moves or vibrates upon receiving one or more of the electromagnetic frequencies to reduce thrombosis.

Description

Technical Field

[0001] Cross - reference to Related Art This application claims the benefit of the filing of U.S. Provisional Patent Application No. 63 / 348,473, filed Jun. 2, 2022, entitled “VASCULAR PUMP,” the disclosure of which is hereby incorporated by reference in its entirety. This application generally relates to medical devices, and more specifically, to magnetically and / or electromagnetically activated circulatory assist devices and related methods that can be disposed within a blood vessel (e.g., an artery or vein). More specifically, this application discloses an intravascular circulatory assist device that includes a pulsed balloon or chamber that includes a material configured to vibrate, resonate, or move in response to an applied electric or magnetic field, and methods related to the use of the circulatory assist device.

Background Art

[0002] Maintaining and improving blood flow before, during, or after a medical procedure, heart conditions, and heart failure can involve percutaneous coronary intervention (“PCI”). PCI can be essential for preventing or removing the adverse effects of deep vein thrombosis (“DVT”), pulmonary embolism, and venous thromboembolism (“VTE”). Circulatory assist devices such as circulatory assist pumps, left ventricular assist devices, pacemakers, and long - term use catheters are often used in PCI to reduce, prevent, or remove angina, blood clots, calcium deposits, plaque accumulation (e.g., atherosclerosis), and / or plaque formation on blood - contacting surfaces.

[0003] Hemolysis is a condition in which red blood cells are broken down or damaged. Circulatory assist devices that use impellers can facilitate or cause hemolysis. Internally, circulatory assist devices can have thrombi formed within them, and the circulatory assist devices can dislodge and move into the body, causing the adverse effects that these devices are intended to prevent or remove.

[0004] U.S. Patent No. 8,617,239 (Reitan) (December 13, 2013), incorporated herein by reference, relates to a catheter pump positioned in the ascending aorta near the human aortic valve and having an elongated sleeve with a drive cable extending through the sleeve and connectable at its proximal end to an external drive source, and a drive rotor near the distal end of the drive cable attached to a drive shaft connected to the drive cable. The drive rotor consists of a propeller enclosed within a cage, and the propeller and cage are foldable from an insertion position close to the drive shaft to an expanded working position, which is characterized by means for fixing the drive rotor in the ascending aorta near the aortic valve after insertion. Also described is a method of positioning the pump of the catheter pump in the ascending aorta just above the aortic valve.

[0005] U.S. Patent No. 8,617,239 (Reitan) is constructed based on Reitan's prior patent, namely U.S. Patent No. 5,749,855 (Reitan) (May 12, 1998), the content of which is also incorporated herein by reference, and relates to a drive cable. One end of the drive cable is connectable to a drive source, and a foldable drive propeller is at the other end of the drive cable. The foldable drive propeller is adjustable between a closed configuration in which the foldable drive propeller is folded on the drive cable and an open configuration in which the foldable drive propeller is expanded to operate as an impeller. The sleeve extends between one side and the other side of the foldable drive propeller, and the sleeve is movable between configurations in which the foldable drive propeller is in the open and closed configurations. The lattice cage is disposed to surround the propeller and is folded simultaneously with the propeller.

[0006] Even earlier blood pump catheters are described in U.S. Patent No. 4,753,221 (Kensey et al.) (June 28, 1988), the contents of which are incorporated herein by reference. Kensey et al. relate to an elongated catheter for pumping blood through at least a portion of a subject's vascular system. The catheter has a diameter and flexibility small enough to allow the catheter to pass through the vascular system such that the distal end portion of the catheter is positioned within or adjacent to the patient's heart. A rotatable pump is located at the distal end of the catheter and is rotated by drive means within the catheter. The distal end portion of the catheter includes an inlet through which blood flows and an outlet from which blood flows. The catheter is arranged such that blood is pumped by the catheter through the heart and into the vascular system without the need for the pumping action of the heart.

[0007] Other catheter pumps are known from US 2008 / 0132748 A1, US 2008 / 0114339 A1, U.S. Patent No. 11,602,627, and WO03 / 103745A2, the contents of each of which are incorporated herein by reference.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Non-Patent Literature

[0009]

Non-Patent Literature 1

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Non-Patent Literature 5

[0010] The foregoing background related to the circulatory assist device is merely intended to provide a contextual overview of some current problems and is not intended to be exhaustive. Other contextual information may become apparent to those of ordinary skill in the art when considering the following description, including exemplary embodiments. **Means for Solving the Problems**

[0011] This specification describes a vascular device that simulates the pulsation of a patient's blood flow by utilizing at least one electromagnetically and / or magnetically activated chamber (e.g., a balloon). Embodiments of this specification may be used to promote blood flow within a target blood vessel. Additionally, embodiments of this specification may be utilized to compress and / or disrupt plaque accumulated within a target blood vessel to improve the flow through each blood vessel.

[0012] In some embodiments, such a device includes a distal end and a proximal end and has a sensor attached to the distal end for receiving an electromagnetic frequency for controlling an impeller. The impeller moves intravascular fluid based on the received electromagnetic frequency. Two or more (e.g., balloon) chambers are positioned proximal and distal to the impeller. The impeller is positioned between the two or more chambers. The chambers may include a vibrating material or a piezoelectric material that moves or vibrates in response to receipt of one or more of the electromagnetic frequencies.

[0013] In some embodiments, the circulatory assist device utilizes one or more devices (e.g., electromagnets) positioned immediately above the patient's skin that generate an electric field, a magnetic field, and / or an electromagnetic field via transcutaneous transmission to partially and / or fully activate one or more operable parts of the device (e.g., an impeller, a balloon, etc.). In other words, the electric field, the magnetic field, or the electromagnetic field is transmitted through the subject's skin, tissue, and blood vessels to the device within the patient's blood vessels. In response to the applied electric field, magnetic field, or electromagnetic field, one or more operable parts of the device within the patient's blood vessels may move (e.g., vibrate, operate, contract, or expand).

[0014] Movement in the exact opposite direction (e.g., contraction and / or expansion) of the operable part of the device contributes to the pulsatile blood flow within the blood vessel. Further, the contraction and / or expansion of the operable part of the device (e.g., the balloon) may be coordinated with the pulsatile blood flow originating from the patient's heart.

[0015] An electric field, a magnetic field, or an electromagnetic field may be applied to reduce thrombosis associated with the device in various ways. For example, in some embodiments, the magnetic field may be applied by a single electromagnet external to the subject. In embodiments having a single electromagnet, the magnetic field may be adjusted and / or concentrated (e.g., focused, localized) in a plane and / or at one of the operable parts of the balloon or sensor. Further, the focused magnetic field may be directed as desired, such as through the use of a controller that directs the magnetic field.

[0016] In additional embodiments, the magnetic field may be applied by a plurality of selectively operable external electromagnets. The electromagnets may be arranged in series such that they can be continuously activated and then deactivated to vary the vibration (e.g., pulsation, contraction, or expansion) of a part of the device.

[0017] In further embodiments, the magnetic field may be applied by one or more internal electromagnets positioned within a device positioned within the subject's blood vessel. For example, the device may be capable of generating a current within a distally positioned sensor that activates the internal electromagnet to generate an internal magnetic field.

[0018] In some embodiments, the device includes a drive shaft having a plurality of independently operable portions (e.g., balloons or chambers) arranged in series along the length of the drive shaft. Each of the independently operable portions or sections of the operable portions of the device is individually configured to change movement (e.g., vibration frequency, contraction, or expansion) in response to an applied magnetic field. For example, each of the operable portions or sections of each of the operable portions of the device may be independently actuated by a focused (e.g., focused, localized) magnetic field applied to the respective operable portion, which may change the vibration frequency of the respective operable portion of the device. In some embodiments, each of the operable portions or each of the sections of each of the operable portions of the device may be continuously actuated (e.g., by a moving magnetic field) such that the vibration of the balloon changes continuously along the length of the device to reduce thrombosis associated with such a stationary device.

[0019] Accordingly, among other things, a pulsed drive shaft including one or more balloons is described. The first balloon or chamber of the device may be biased to vibrate at a first frequency. The second balloon or chamber of the device may be biased to vibrate at a second frequency such that at least a portion of the device is configured to simulate blood flow in a patient's blood vessel in response to an applied magnetic field.

[0020] In some embodiments, the device may include additional components beyond the drive shaft and balloon. For example, the device may include one or more electromagnets that can remain outside the subject and generate a magnetic field for changing the movement of the operable portions of the device.

[0021] Furthermore, the device may include (or be associated with) a controller and / or a power source that communicates with the electromagnet. The controller may be configured to adjust (e.g., of the electromagnet) an electric field, an electromagnetic field, or a magnetic field and / or to direct an electric field, an electromagnetic field, or a magnetic field. In embodiments including a plurality of electromagnets, the controller may be configured to selectively activate and deactivate each electromagnet to move the position of the magnetic field.

[0022] In further embodiments of the present disclosure, a method of promoting pulsation of blood flow includes placing an assist device within a patient's blood vessel. The device includes a drive shaft having a portion that includes a piezoelectric material or a vibrating material. The portion of the device may be configured to move in response to an electric field, an electromagnetic field, or a magnetic field. The method further includes applying an electric field, an electromagnetic field, or a magnetic field to a portion of the device to vary movement (e.g., vibration) of one or more portions of the device (e.g., a balloon).

[0023] For a more complete understanding of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawings, in which like elements are generally designated by like numerals.

Brief Description of the Drawings

[0024]

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[0025] One aspect of the present disclosure is generally circulatory assist devices 100 and 101 shown in the expanded and contracted positions in FIGS. 1, 2A, 2B, 3A, and 3B. As can be judged, the accompanying drawings are generally not drawn to scale.

[0026] The circulatory assist device may be disposed, for example, on the aorta above the renal artery to assist renal function or on the aorta to assist cardiac function. Increased flow to the kidneys means more rapid removal of excess fluid, which leads to better recovery of renal function. In certain embodiments, it is preferred that the system uses the full diameter of the renal artery or aorta to increase pump stability and reduce pump movement.

[0027] In certain embodiments, the circulatory assist device may be communicatively coupled to an implanted sensor that assists with real-time, automatic adjustment, and management of the circulatory assist device based on data provided by the implanted (preferably wireless) sensor. The sensor monitors fluid flow and provides feedback and data to the circulatory assist device, or to a controller operably coupled to the circulatory assist device, where the feedback and data are used, for example, to adjust the speed and / or angle of an impeller, to increase or decrease fluid flow and pressure, or to increase or decrease piezoelectric vibrations.

[0028] Wireless power embodiments are designed to reduce the risk of infection compared to external drive line systems. Also, the wireless power option helps to improve the quality of life of the patient utilizing the device. Typically, the patient is a mammalian subject such as a human. Optionally, the circulatory assist device may be utilized with one or more cuff stent grafts that improve total flow, improve hemodynamics, improve the release of beneficial proteins for organ health (via pulsatile flow), and reduce the RPM required by the impeller to reach a desired flow.

[0029] In some embodiments, elements of the circulatory assist device described herein (e.g., impeller blades, drive shafts, and / or stent cages) are coated with a hydrophobic or lubricious material to reduce the likelihood of endothelialization after placement of the circulatory assist device. Such materials can be, for example, expanded polytetrafluoroethylene (ePTFE available from Gore Technologies) or similar graft liners.

[0030] Referring to FIG. 1, in some embodiments, the circulatory assist device 100 includes a distal end 103 and a proximal end 105. The distal end 103 of the device 100 includes a sensor 102, and the proximal end 105 includes a placement catheter 104. The placement catheter 104 may be sized and shaped for subcutaneous insertion into the patient 130 at the incision site 131 (FIG. 11, below).

[0031] Referring to FIGS. 2A and 2B, the circulatory assist device 100 includes an impeller 106 positioned between its distal end 103 and proximal end 105. In some embodiments, the impeller 106 includes a helical-shaped continuous (e.g., no intervening material or holes) blade and a drive shaft 128 extending along the central axis of the helical blade. In some of these embodiments, the helical blades of the impeller 106 may be semi - continuous or may have some discontinuities, such as including holes, baffles, protrusions, or other materials. The perimeter of the helical blade may be slightly smaller than the inner circumference of a tubular elongate casing (FIG. 4, below).

[0032] In some embodiments, the circulatory assist device 100 includes a sensor 102. In the illustrated embodiment, the sensor 102 is positioned (e.g., attached, but not limited to) at the distal end 103. The sensor 102 is configured to receive an electromagnetic frequency 146 for controlling the impeller 106. The impeller 106 is configured to operate electrically (e.g., wirelessly or via direct electrical coupling) to move the intravascular fluid 121 based on the electromagnetic frequency 146 received by the sensor 102.

[0033] In some embodiments, the circulatory assist device 100 includes a balloon 108, the interior of which defines a balloon chamber (see FIG. 6). In some of these embodiments, two or more balloons 108 are coaxially connected and aligned with the drive line 122 and drive shaft 128 of the impeller 106. The drive line 122 may be enclosed within a tubular elongate casing, which may extend from the impeller 106. In some embodiments, two or more balloons 108 each including a balloon chamber (see FIG. 6) are positioned proximal and distal to the impeller 106. In other words, the impeller 106 is positioned between two or more balloon chambers.

[0034] The circulatory assist device 100 includes a stent cage 110. The stent cage 110 is sized and shaped to be disposed within a blood vessel 116 (FIG. 5, below). The stent cage 110 is configured to move between an expanded position 112 (FIG. 2A) and a collapsed position 114 (FIG. 2B). In various embodiments, the stent cage 110 includes a highly open flow configuration that can prevent damage to the patient's blood cells, such as hemolysis. The highly open flow configuration can also reduce the risk of thrombosis. In some embodiments, the stent cage 110 includes one or more wires, each having a surface that is smoothed or formed in a manner configured to reduce friction or damage to the wall 120 of the blood vessel 116.

[0035] The stent cage 110 can be configured to be sufficiently rigid to maintain fixation in the expanded (e.g., deployed or open) position 112 while being fixed to the blood vessel 116 (e.g., aorta) of the patient 130, and yet be sufficiently flexible to allow for variations due to the natural pulsatility of the blood vessel 116 of the patient 130.

[0036] By maintaining the movement of the blood vessel wall during natural pulsation, it is possible to promote the health of multiple organs, particularly the health of the kidneys, avoid plaque formation, and promote the expression of aortic proteins such as Klotho. Maintaining the movement of the blood vessel wall during natural pulsation can also improve blood pressure and hemodynamics. The advantages of natural pulsation are discussed in the following article, the content of which is incorporated herein by reference. Why pulsatility still matters: a review of current knowledge, Davor Baric, Croatian Medical Journal, Volume 55(6), December 2014, pages 609-620, DOI: 10.3325 / cmj.2014.55.609.

[0037] Referring to FIGS. 3A and 3B, in some embodiments, impeller 106 includes one or more impeller blades configured to fold toward drive shaft 128. In some of these embodiments, the illustrated impeller blades are pivotally associated with the lobe by a pivot (eg, a pin or shaft). The impeller blades are foldable and stowable outwardly and can, for example, move to a position perpendicular to drive shaft 128. The impeller blades may be configured to fold simultaneously with stent cage 110 while stent cage 110 is moving to the collapsed position 114, while in other embodiments, the impeller blades may be actuated separately from stent cage 110 (eg, folded to drive shaft 128 while stent cage 110 remains in the expanded position 112). In any embodiment, stent cage 110 is configured to prevent contact between the wall 120 of blood vessel 116 (eg, the aortic tissue of patient 130) and the impeller blades of impeller 106.

[0038] In some embodiments, impeller 106 includes a combination of one or more impeller blades configured to be folded and one or more helical blades. Impeller 106 may include other types of impeller blades and may include any combination of impeller blades.

[0039] Referring to FIG. 4, in some embodiments, the collapsed position 114 is circumferentially smaller than the inner circumference 118 of the wall 120 of the blood vessel 116, while the expanded position 112 is circumferentially greater than or equal to the inner circumference 118 of the wall 120 of the blood vessel 116.

[0040] Referring to FIG. 5, in some embodiments, the circulatory assist device 100 / 101 and the deployment catheter 104 use a monorail guidewire lumen “rapid exchange” (“RX”) system that includes a tubular elongate casing that houses a guidewire lumen within the circulatory assist device 100 / 101. A portion of the RX system of the deployment catheter 104 is configured to extend proximally a short distance from its tip. For example, as described in US 2003 / 0171642 A1 (Schock et al.) (Sep. 11, 2003) and J. Schroeder 2013 Peripheral Vascular Interventions: An Illustrated Manual, “Balloon catheters Over the Wire and Monorail,” DOI: 10.1055 / b-0034-65946, the contents of each of which are incorporated herein by reference. In some embodiments, the deployment catheter 104 includes a telescoping end 125 that includes a casing 133 integrally and telescopically integrated with one or more sleeves 129. For example, the casing 133 is surrounded by a tube of an elastic material such as a sleeve 129 or rubber.

[0041] The deployment catheter 104 includes a guidewire lumen 123 and a portion enclosed within the casing 133. In some embodiments, the guidewire lumen 123 is configured to connect to the guidewire lumen of the circulatory assist device 100 and supply fluid thereto.

[0042] The placement catheter 104 includes a mechanism 127 configured to secure the circulatory assist device 100 to the placement catheter 104 for positioning the circulatory assist device 100 within a patient's body. In some embodiments, the impeller 106 is configured to be wirelessly activated after the circulatory assist device 100 / 101 is removed from the mechanism 127. In some embodiments, the mechanism 127 is positioned at an end of the guidewire lumen 123.

[0043] In some embodiments, the drive line 122 and an "over-the-wire" (OTW) guidewire may be enclosed within the tubular elongate casing of the impeller 106, and the impeller 106 is directly electrically and mechanically coupled and operates on a direct (e.g., wired) electrical connection. The impeller 106 is connected to a drive shaft 128 to operate the impeller 106 upon receipt of an activation signal.

[0044] The guidewire lumen 123 is shown as a solid material for simplicity of illustration. It is important to note that in some embodiments, all or at least a portion of the guidewire lumen 123 is hollow to allow fluid (e.g., air) to pass into the guidewire lumen of the circulatory assist device 100 / 101 and into the balloon 108 of the circulatory assist device 100 / 101. In some embodiments, the guidewire lumen 123 houses an operating cable that may be used to operate the circulatory assist device 100 / 101. In other embodiments, the operating cable comprises a guidewire lumen 123 that may be substantially solid.

[0045] Referring to FIGS. 6 and 7, balloon 108 includes a balloon wall 109 that defines a chamber of balloon 108. Balloon 108 includes a body portion 132 that smoothly or continuously transitions to an attachment portion 134. In other embodiments, the transition between body portion 132 and attachment portion 134 may lack continuity due to folds that result from the balloon 108 being stored in a collapsed position 114 before or after use of the balloon 108 and circulatory assist device 100 / 101. Attachment portion 134 may be of an annular shape (e.g., circular annular, square annular, elliptical annular, etc.) and may include a lip or ridge 135 configured to secure balloon 108 to a portion of drive shaft 128. Although a single lip or ridge 135 is shown, in some embodiments, attachment portion 134 includes multiple lips or ridges 135. In some embodiments, attachment portion 134 includes an adhesive or heat bond configured to attach the balloon to drive shaft 128. In some of these embodiments, attachment portion 134 includes one or more lips or ridges 135 and one or more of an adhesive and a heat bond. In some embodiments, as shown in FIGS. 2A, 3A, and 3B, two balloons 128 are positioned proximally and distally near opposite ends of drive shaft 128 and the two balloons are separated by impeller 106. Drive shaft 128 or a portion thereof may be hollow for fluid communication (e.g., inflation and / or deflation) to the balloon chamber of balloon 108 or may include a separate guide wire lumen therein.

[0046] The balloon wall 109 may include one or more materials. For example, the balloon wall 109 may include a piezoelectric material 124. The piezoelectric material 124 may include piezoelectric crystals such as perovskite crystals. The crystal structure may include tetravalent metal ions in a lattice of large divalent metal ions. The piezoelectric crystal may be lead zirconate titanate (PbZrxTi1-xO3 having 0 ≦ × ≦ 1, for example, PZT-5A, PZT-5H, PZT 5-J, PZT-4, PZT-8), potassium niobate (KNbO₃), sodium tungstate (Na2WO3), Ba2NaNb5O5, Pb2KNb5O15, zinc oxide (ZnO), etc., one or more ceramics, and lead-free piezoelectric ceramics such as sodium potassium niobate ((K,Na)NbO3), bismuth ferrite (BiFeO3), sodium niobate (NaNbO3), barium titanate (BaTiO3), bismuth titanate (Bi4Ti3O12), sodium bismuth titanate (NaBi(TiO3)2), etc., group III-V and II-VI semiconductors such as gallium nitride (GaN), indium nitride (InN), aluminum nitride (AlN), zinc oxide (ZnO), etc., polymers such as polyvinylidene fluoride (PVDF) and its copolymers, polyamide, parylene-C, polyimide, and polyvinylidene chloride (PVDC), and various other crystalline materials such as langasite (La3Ga5SiO14), gallium orthophosphate (GaPO4), lithium niobate (LiNbO3), lithium tantalate (LiTaO3), quartz, berlinite (AlPO4), Rochelle salt, topaz, tourmaline group minerals, and lead titanate (PbTiO3). The piezoelectric material 124 may be an organic piezoelectric biogenic material or an inorganic material. The organic piezoelectric biogenic material may include, but is not limited to, piezoelectric proteins, peptides, and other biopolymers. The piezoelectric material 124 may be a non-synthetic material or a synthetic material.For example, see Shin, Dong-Myeong, et al., “Recent Advances in Organic Piezoelectric Biomaterials for Energy and Biomedical Applications,” Nanomaterials, Volume 10(1), Jan 9, 2020, DOI 10.3390 / nano10010123. The content is incorporated by reference in its entirety. The non-synthetic piezoelectric material 124 can include, but is not limited to, berlinite, sucrose, quartz, Rochelle salt, topaz, tourmaline, bone, or combinations thereof. For example, “The Piezoelectric Effect,” Nanomotion, a Johnson Electric Company,。 1738118004881_0 (Accessed on June 2, 2022).

[0047] The shape and size of the piezoelectric material 124 can vary depending on its desired movement and / or application. For example, relatively small ellipsoids, cubes, granules, etc. can be useful for mechanical vibrations, while rods, cylinders, or relatively elongated structures can be useful for expansion and contraction movements.

[0048] The movement generated by the piezoelectric material 124 may mimic natural pulsations and the movement of blood vessel walls. The piezoelectric material 124 may be configured to receive an electromagnetic frequency 146 and move based on the received electromagnetic frequency 146. For example, in some embodiments, the piezoelectric material 124 may convert an electrical signal (e.g., a wireless signal, radio frequency, etc.) into a mechanical vibration. In other embodiments, the piezoelectric material 124 may convert an electrical signal into a series of contractions and expansions (e.g., depending on the shape and size of the piezoelectric material 124), providing an electromechanical simulation of natural rhythmic blood flow.

[0049] The blood flow within blood vessel 116 may be characterized by one or more hydrodynamic relationships such as the Reynolds number, Bernoulli's equation, and / or the Navier-Stokes equations. As the area around blood vessel 116 decreases, for example, due to plaque buildup, the preferred laminar flow of the intravascular fluid 121 may be converted to turbulent flow. See, for example, Klabunde, Richard E., “Turbulent Flow,” cardiovascular Physiology Concepts, Wolters Kluwer 2021, 3rd Ed. (www.cvphysiology.com / Hemodynamics / H007). Without being bound by theory, the vibrations of the piezoelectric material 124 may help return turbulent flow to laminar flow. For example, the vibrations may facilitate movement to the vessel wall 120 that helps increase the diameter of the wall 120, or the vibrations may affect the fluid velocity and / or flow rate that also affects turbulent and laminar flow.

[0050] In additional embodiments, the vibration enhancing material 126 may be housed within the balloon chamber alone or in combination with the piezoelectric material 124. The vibration enhancing material 126 may include a lattice or a material having atoms arranged in a substantially uniform distribution such as metals, ceramics, crystals (e.g., centrosymmetric). The vibration enhancing material 126 may enhance vibrations from movable components of the circulation assist device 100 / 101 such as the drive shaft 128.

[0051] The body portion 132 including the balloon wall 109 may include an elastomeric material such as, for example, silicone, and the portion of the balloon wall 109 that defines the balloon chamber may be slightly expandable so that the balloon chamber can be inflated and vibrated after the circulation assist device 100 / 101 is inserted into the body of the patient 130. Prior to insertion, the balloon chamber of each balloon 108 may be in a fully deflated state, allowing for a low-profile insertion of the circulation assist device 100 / 101 into the body of the patient 130. Once inserted, fluid (e.g., a gas such as air) can flow through the guidewire lumen 123 of the placement catheter 104 to the drive shaft 128 of the impeller 106 and into the balloon chamber, facilitating inflation and expansion for the desired vibration of the balloon 108. In other embodiments, the balloon 108 is formed of a compressible elastomeric material such that it is compressed when the balloon 108 is in a contracted state and decompressed when in an expanded state. In these embodiments, the balloon 108 does not inflate through the lumen of the guidewire, but rather expands and contracts due to the compression and decompression of the balloon material and any compressible fluid (e.g., an inert gas) contained therein.

[0052] The flexible or elastomeric material of the body portion 132 of the balloon 108 is configured to vibrate based on the movement of the impeller 106. For example, the impeller 106 can increase, decrease, or contain a wide range of blood flow rates during operation of the circulation assist device 100 / 101 based on several different factors (e.g., input from implantable sensors). The flexibility or elasticity of the material of the body portion 132 may be selected based on the average expected flow rate, a threshold flow rate (e.g., maximum or minimum), or a target flow rate. Thus, if the average expected flow rate is high, a material with low elasticity or flexibility may be selected, and conversely, if the average expected flow rate is low, a material with high elasticity or flexibility may be selected. Biocompatible rubber, latex, polymers (e.g., polypropylene), silicone, or combinations thereof may be one of the selected ones.

[0053] In some embodiments, the body portion 132 generally includes a teardrop shape. However, other shapes are contemplated. For example, the body portion 132 may assume an annular shape, thereby allowing the drive shaft 128 to pass through the central portion of the annular shape. Other shapes include, but are not limited to, spherical, hemispherical, elongated, and combinations thereof. The attachment portion 134 may include a ring shape, an annular shape, or combinations thereof so as to be insertable within the end of the drive shaft 128 or disposed (e.g., thereon) around the end.

[0054] In some embodiments, two or more balloons 108 include a piezoelectric material 124. In other embodiments, at least one balloon 108 contains a piezoelectric material 124 while at least one other balloon 108 contains a vibration enhancing material 126. In additional embodiments, two or more balloons 108 each contain both a piezoelectric material 124 and a vibration enhancing material 126. A plurality of balloons 108 (e.g., three, four, five, or more) may be aligned concentrically with the drive shaft 128 of the circulation assist device 100 / 101, and various combinations of materials within each respective balloon 108 or group of balloons 108 are recognized and included herein.

[0055] Referring to FIG. 8, in some embodiments, the sensor 102 includes a microprocessor 136, an electromagnetic (e.g., RF) receiver or transceiver 138, a power source 140 (e.g., a battery), and a motor 148. The power source 140 may provide power to the microprocessor 136, the transceiver 138, and the motor 148. The sensor 102 includes a body portion 142 (e.g., a radome) made of an RF transparent material 144 such as TEFLON®, glass, plastic, and combinations thereof.

[0056] The transmitter 144 may transmit one or more electromagnetic signals (RF signals, Wi-Fi (registered trademark), BLUETOOTH (registered trademark), etc.) 146 to the transceiver 138. Upon receiving the electromagnetic signal 146, the microprocessor 136 may generate an activation signal to transmit to the motor 148. Upon receiving the activation signal, the motor 148 then activates the impeller 106. In other embodiments, one or more components of the sensor 102 may be removed and / or added. For example, one or more electromagnets may be included within the sensor 102. As another example, the motor 148 may not be present if the placement catheter 104 uses a direct electrical and / or mechanical connection to the motor control drive unit 158 (FIG. 9, below), or an additional flow sensor may be positioned distally at the tip of the sensor 102 to provide additional fluid flow feedback.

[0057] Referring to FIG. 9, the circulation assistance system 150 may include a placement catheter 104 and a circulation assistance device 100 / 101. The placement catheter 104 may be proximal to the proximal end 105 of the circulation assistance system 150, and the circulation assistance device 100 / 101 may be proximal to the distal end 103 of the circulation assistance system 150. The circulation assistance system 150 may include a first sheath drive line 152 configured to rotate the impeller 106 (FIGS. 2A and 3A) of the circulation assistance device 100 / 101. The first sheath drive line 152 may be configured to control the movement of the drive shaft 128 (FIGS. 2A and 3A) and / or the placement catheter 104.

[0058] In some embodiments, the circulatory assist system 150 may include a second sheath drive line 154 configured to facilitate movement and / or rotation of the casing 150 (FIGS. 2A and 3A) and / or the placement catheter 104. The circulatory assist system 150 may include a power source 156 (e.g., a medical grade UPS) that facilitates conveyance and can provide power to the circulatory assist system 150. Further, the circulatory assist system 150 may include a motor drive control unit 158 configured to facilitate movement and / or rotation of the impeller 106 (FIGS. 2A and 3A), the casing 122 (FIGS. 2A and 3A), and / or the placement catheter 104.

[0059] In some embodiments, the sensor is used with the circulatory assist system 150, for example, to monitor hemolysis and / or impeller speed, and the pulsation of the cuff is adjusted as desired to balance minimizing hemolysis and maximizing the flow utilizing the system 150.

[0060] The circulatory assist system 150 can be used not only to maintain the life of the patient 130 (e.g., congestive heart failure), but also to provide mechanical circulatory assistance for up to, for example, 36 months during the process of cardiac rehabilitation / regenerative therapy.

[0061] The impeller 106 (FIGS. 2A and 3A) of the circulatory assist device 100 / 101 and the circulatory assist system 150 may be configured to operate (e.g., rotate) mechanically via an elongate portion of a placement catheter (FIG. 5) operably coupled to the drive shaft 128 and the motor control drive unit 158. In some embodiments, the impeller 106 (FIGS. 2A and 3A) of the circulatory assist device 100 / 101 and the circulatory assist system 150 may be configured to operate (e.g., rotate) wirelessly as described in U.S. Patent Application Publication No. 2021 / 0077687 A1 (Leuonhardt) and U.S. Patent Application Publication No. 2021 / 0008263 A1 (Leuonhardt).

[0062] Referring to FIGS. 10 and 11, during operation, patient 130 includes blood vessel 116 (e.g., artery) selected for incision site 131. In FIG. 11, the dashed box surrounds incision site 131 which is better shown in the exploded view of FIG. 11.

[0063] Placement catheter 104 may be supplied to the aorta at incision site 131, e.g., via the groin (a small incision to the femoral artery), by the normal “Seldinger method” in blood vessel 116 (e.g., inferior aorta), and “percutaneously” introduced to a desired location (e.g., descending aorta). Circulatory assist device 100 / 101 may be inserted into the groin and introduced into blood vessel 116 (e.g., femoral artery just above the renal artery of the descending aorta) using a small surgical insertion and an insertion sheath. Circulatory assist device 100 / 101 is then supplied to a desired location in the inferior aorta.

[0064] Alternatively, circulatory assist device 100 / 101 may be placed via the axillary inlet of the neck or chest of the subject. See, for example, K M. Doersch “Temporary Left Ventricular Assist Device Through an Axillary Access is a Promising Approach to Improve Outcomes in Refractory Cardiogenic Shock Patients,” ASAIO J. 2015 May-Jun; 61(3): 253-258; doi: 10.1097 / MAT.0000000000000222. The content of which is hereby incorporated by reference in its entirety. This describes the implantation of a temporary left ventricular assist device (“LVAD”) via an axillary approach as a method of providing adequate circulation to a patient, avoiding the risks of multiple chest invasions and infections.

[0065] In some embodiments, one or more cuff stent grafts (not shown) are used at the incision site 131 to improve the overall flow of the circulatory assist device 100 / 101, improve hemodynamics, improve the release of beneficial proteins for organ health (via pulsatile flow), and reduce the RPM required by the impeller to reach the desired flow rate.

[0066] In some embodiments, the circulatory assist device 100 / 101 delivered at the incision site 131 is wirelessly driven and includes an impeller 106 housed within the ascending aorta force protection stent cage 110. The circulatory assist device 100 / 101 may be disposed within the ascending aorta that pulsates the aortic cuff stent graft of the patient 130.

[0067] Referring to FIG. 12, the placement catheter 104 is used to position the circulatory assist device 100 / 101 including the sensor 102 at a desired internal venous location 160 within the patient 130. For example, the circulatory assist device 100 / 101 may be delivered just below the renal artery supplying the kidney while being held within the end of the placement catheter 104, such as within the sleeve 129 or casing 133 of the placement catheter 104, and is fixed there by the mechanism 127.

[0068] Referring to FIG. 13, upon reaching the internal venous location 160, the circulatory assist device 100 / 101 is withdrawn from the placement catheter 104. When withdrawn from the placement catheter 104, such as from within the sleeve 129 or casing 133, and positioned within the blood vessel 116, the circulatory assist device 100 / 101 transitions to the expanded position 112, the stent cage 110 expands outwardly, contacts the inner wall of the blood vessel 116, and fixes the circulatory assist device 100 / 101 in place. The transmitter 144 may be configured to transmit an electromagnetic frequency 146 (e.g., a wireless signal or RF) to the transceiver 138 of the sensor 102 that can expand the impeller blades.

[0069] Referring to FIG. 14, the mechanism 127 is actuated to release the circulatory assist device 100 / 101 at the internal vein location 160. When the circulatory assist device 100 / 101 is released, and / or upon receiving the first electromagnetic frequency 146 or the second electromagnetic frequency 146, the microprocessor 136 sends a signal to the motor 148 to operate the impeller 106.

[0070] Referring to FIG. 15, it is an advantage of the circulatory assist device 100 / 101 that it is not necessary to cross the renal artery supplying the kidney. However, in certain embodiments, the circulatory assist device 100 / 101 is included in a circulatory assist system that includes a second circulatory assist device 200 positioned on the opposite side of the renal artery relative to the circulatory assist device 100 / 101 (e.g., for high-head / low-flow applications). Such a system includes positioning the circulatory assist device 100 / 101 upstream of the renal valve at the tip of the deployment catheter 104 across the renal artery. In some embodiments, the second circulatory assist device 200 includes sensors 202 (similar to sensor 102) proximal and / or downstream of the renal artery supplying the kidney, a stent cage 210, and an impeller (not shown). The impeller, stent cage 210, and sensors 202 may be similar to the features of the circulatory assist device 100 / 101. In some embodiments, one of the circulatory assist devices 100 / 101, 200 is configured to further extend a drive shaft to interact with and drive the other of the circulatory assist devices 100 / 101, 200. The two circulatory assist devices 100 / 101 and 200 are arranged in series. In some embodiments, the two circulatory assist devices 100 / 101 and 200 are arranged using the same catheter and may utilize the same drive shaft. In other embodiments, one or both of the two circulatory assist devices 100 / 101 and 200 are operated wirelessly and may or may not share the same drive shaft. In another embodiment, the second circulatory assist device 200 includes only the stent cage 210 and is configured to expand the blood vessel 116 and assist in ensuring blood flow therethrough.

[0071] In additional embodiments, the circulatory assist device 100 / 101 may be arranged to operate at a higher location within the patient 130 (e.g., at or near the heart for purposes such as reducing the load on the left ventricle). In these embodiments, the first circulatory assist device 100 / 101 is positioned to pass through a heart valve, and the second circulatory assist device 200 is positioned in the lower aorta just above the renal artery (for improving renal output), i.e., the second circulatory assist device 200 is positioned within the blood vessel 116 from the middle part to the lower part of the stomach or adjacent thereto, and the first circulatory assist device 100 / 101 is positioned within the blood vessel 116 at or adjacent to the upper middle chest (usually 20 - 30 cm in most people).

[0072] The treatment and / or PCI typically lasts for 6 hours, but may last for 72 hours, for example.

[0073] Although illustrated for a device with a drive shaft and balloon inserted containing a piezoelectric material or a vibrating material, it is important to note that other configurations are contemplated and included herein. For example, a drive shaft, an impeller, and a balloon containing a piezoelectric material or a vibrating material may be used in an externally located left ventricular assist device. Other arrangements, configurations, and uses will be recognized by those skilled in the art and are included herein.

[0074] In the above uses, reference is made to the specific features (including the acts of the methods) of the present disclosure in the following claims and the accompanying drawings. It should be understood that the present disclosure includes all possible combinations of such specific features. For example, if a particular feature is disclosed in the context of a particular embodiment or a particular claim, that feature can be used in combination with and / or in the context of other specific aspects and embodiments described herein to the extent possible.

[0075] The foregoing description provides specific details such as components, assemblies, and materials in order to provide a complete description of embodiments of the present disclosure. However, those skilled in the art will understand that embodiments of the present disclosure can be implemented without these specific details.

[0076] The use of the term "for example" means that the associated description is illustrative, but while the scope of the present disclosure is intended to include examples and legal equivalents, the use of such terms is not intended to limit the embodiments or the scope of the present disclosure to the specified components, acts, features, functions, etc.

[0077] The drawings presented herein are for illustrative purposes and are not necessarily intended to be actual drawings of any particular material, component, structure, or device. Accordingly, the embodiments described herein should not be construed as being limited to the specific shapes or regions illustrated, and may include, for example, shape deviations resulting from manufacturing. For example, a region illustrated or described as box-shaped may have rough and / or non-linear features, and a region illustrated or described as round may include some rough and / or linear features. Further, the acute angles illustrated may be rounded, and vice versa. Thus, the regions illustrated in the figures are essentially schematic, and their shapes are not intended to illustrate the exact shape of the regions and do not limit the claims. The drawings are not necessarily to scale. Further, common elements between figures may retain the same numerical designation.

[0078] As used herein, the term "configured to" refers to one or more sizes, shapes, material compositions, material distributions, orientations, and arrangements of at least one structure and at least one device, and facilitates one or more operations of the structure and device in a predetermined manner.

[0079] As used herein, the terms "comprising," "including," and their grammatical equivalents are open - ended terms that do not exclude additional unrecited elements or acts, and include both more restrictive terms such as "consisting of" and "consisting essentially of" and their grammatical equivalents.

[0080] As used herein, the term "may" with respect to a material, structure, feature, or method is intended for use in the practice of embodiments of the present disclosure, and such term is used preferentially over the more restrictive term "is" to avoid any implication that other compatible materials, structures, features, and methods that may be used in combination therewith should or should not be excluded.

[0081] As used herein, the singular forms "a," "an," and "the" include plural forms as well, unless the context clearly dictates otherwise.

[0082] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0083] As used herein, relational terms such as "first," "second," etc. are used for clarity and convenience in understanding the present disclosure and the accompanying drawings, and do not imply or depend on any particular preference, orientation, or order, unless the context clearly dictates otherwise.

[0084] As used herein, when used in connection with a numerical value of a particular parameter, the term "about" includes the numerical value and the degree of variation from the numerical value that would be understood by one of ordinary skill in the art to be within an acceptable tolerance for the particular parameter. For example, "about" with respect to a numerical value may include additional numerical values within the range of 90.0 percent to 110.0 percent of the numerical value, such as within the range of 95.0 percent to 105.0 percent of the numerical value, within the range of 97.5 percent to 102.5 percent of the numerical value, within the range of 99.0 percent to 101.0 percent of the numerical value, within the range of 99.5 percent to 100.5 percent of the numerical value, or within the range of 99.9 percent to 100.1 percent of the numerical value.

[0085] As used herein, the term "substantially" with respect to a given parameter, property, or condition means to the extent that one of ordinary skill in the art would understand that the given parameter, property, or condition is met with a degree of variation, such as within an acceptable tolerance. By way of example, depending on the particular parameter, property, or condition being substantially met, the parameter, property, or condition may be met to at least 90.0 percent, at least 95.0 percent, at least 99.0 percent, at least 99.9 percent, or even 100.0 percent.

[0086] As used herein, the term "biocompatible material" refers to any material suitable for being present within the body of a subject. Biocompatible materials include ceramics, and alumina (Al2O3), zirconia (ZrO2), hydroxyapatite (Ca 10(PO4)6(OH)2), and ceramic composite materials such as bioglass (e.g., a composite material containing silica (SiO2), calcium (Ca), sodium oxide (Na2O), hydrogen (H), and / or phosphorus (P)). As a non-limiting example, bioglass may include 45S5 (e.g., 45% SiO2, 24.5% CaO, 24.5% Na2O, and 6% Na2O(P2O5)), as well as additional compositions described in the following articles, the contents of which are incorporated herein by reference: Vidya Krishnan and T. Lakshmi, “Bioglass: A novel biocompatible innovation,” Journal of Advanced Pharmaceutical Technology & Research, Volume 4(2), Apr-Jun 2013, pages 78-83, DOI: 10.4103 / 2231-4040.111523. The biocompatible material may additionally include metals and metal alloys such as stainless steel, titanium, and titanium alloys (e.g., nitinol), cobalt-chromium alloys (e.g., ASTM F75). Further, the biocompatible material may include polymers such as polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyetheretherketone (“PEEK”), poly-p-phenylene terephthalamide (K29) (e.g., KEVLAR®), p-phenylene terephthalamide (PpPTA) (e.g., TWARON®), polymethyl methacrylate (PMMA), trimethyl carbonate (C4H6O3), TMC NAD-lactide (CH3 m [C4H6O3] n CH3), polylactic acid (PLA), and medical silicone.

[0087] As used herein, the term “vessel” means any vessel or artery used internally or externally with respect to the body of a patient (e.g., human or animal) that conveys a fluid such as blood to or from one or more organs of the patient.

[0088] As used herein, the term "piezoelectric" when used in connection with a material means any material (e.g., non-centrosymmetric) that is electrically tunable or that experiences contraction, elongation, or similar property changes upon the application, exposure, or reception of an electric field, magnetic field, or electromagnetic field. This term may also refer to a material that generates an electric charge in response to an applied mechanical stress.

[0089] [Patent Documents] (each of which is hereby incorporated by reference in its entirety) U.S. Patent No. 8,617,239 (December 31, 2013) entitled "Catheter Pump" (Reitan). U.S. Patent No. 5,749,855 (May 12, 1998) entitled "Catheter Pump" (Reitan). U.S. Patent No. 4,753,221 (June 28, 1988) entitled "Blood Pumping Catheter and Method of Use" (Kensey et al.). Vidya Krishnan and T. Lakshmi, “Bioglass: A novel biocompatible innovation,”Journal of Advanced Pharmaceutical Technology & Research,Volume 4(2),Apr-Jun 2013,pages 78-83,DOI: 10.4103 / 2231-4040.111523. David Baric, “Why pulsatility still matters: a review of current knowledge,” Croatian Medical Journal, Volume 55(6), December 2014, pages 609-620, DOI: 10.3325 / cmj.2014.55.609. U.S. Patent Application Publication No. 2003 / 0171642 A1, entitled "Intra-aortic Balloon Catheter Having a Releasable Guide Wire" (Schock et al.) (September 11, 2003). See Juergen Schroeder, “Peripheral Vascular Interventions: An Illustrated Manual,” Thieme Verlagsgruppe, Stuttgart, NY, 2013, Balloon Catheters Over the Wire and Monorail, pages 27-28, DOI: 10.1055 / b-0034-65946. “What is ‘PZT’?,” APC International, LTD., www.americanpiezo.com / piezo-theory / pzt.html (last visited June 2, 2022). Dong-Myeong Shin,et al.,“Recent Advances in Organic Piezoelectric Biomaterials for Energy and Biomedical Applications,”Nanomaterials,Volume 10(1),Jan 9,2020,DOI:10.3390 / nano10010123. “The Piezoelectric Effect,” Nanomotion, a Johnson Electric Company, www.nanomotion.com / nanomotion-technology / piezoelectric-effect / (last visited June 2, 2022). Richard E. Klabunde, PhD, “Turbulent Flow,” Cariovascular Physiology Concepts, Wolters Kluwer 2021, 3 rd Ed. (www.cvphysiology.com / Hemodynamics / H007). U.S. Patent Application Publication No. 2021 / 0077687 A1 entitled "Circulatory Assist pump" (Leuonhardt). U.S. Patent Application Publication No. 2021 / 0008263 A1 entitled "Circulatory Assist pump" (Leuonhardt). U.S. Patent No. 11,602,627 B2 (March 14, 2023) entitled "Circulatory Assist pump" (Leonhardt). K M. Doersch “Temporary Left Ventricular Assist Device Through an Axillary Access is a Promising Approach to Improve Outcomes in Refractory Cardiogenic Shock Patients,” ASAIO J., 2015 May-Jun; 61(3): 253-258; DOI: 10.1097 / MAT.0000000000000222.

Claims

1. A circulatory assist device, comprising: a distal end and a proximal end; an impeller; a sensor attached to at least one of the distal end and the proximal end configured to receive an electromagnetic frequency for controlling the impeller, wherein the impeller is configured to move fluid in response to the received electromagnetic frequency; two or more chambers positioned proximal and distal to the impeller, wherein the impeller is positioned between the two or more chambers.

2. The circulatory assist device according to claim 1, wherein the two or more chambers include a vibration material or a piezoelectric material positioned within a wall thereof and configured to move or vibrate in response to receiving one or more of the electromagnetic frequencies.

3. The circulatory assist device according to claim 1, further comprising a stent cage sized and shaped to be disposed within a target blood vessel, wherein the stent cage is configured to expand within the target blood vessel.

4. The circulatory assist device according to claim 3, wherein the stent cage is configured to transition between an expanded position and a collapsed position.

5. The circulatory assist device according to claim 4, wherein the collapsed position is circumferentially smaller than an inner circumference of a wall of the blood vessel, and the expanded position is circumferentially greater than or equal to the inner circumference of the wall of the blood vessel.

6. The circulatory assist device according to claim 1, wherein the two or more chambers are coaxially positioned and connected along a drive line of the impeller.

7. The circulatory assist device according to claim 1, wherein the two or more chambers contain a piezoelectric material positioned therein.

8. The circulatory assist device according to claim 7, wherein the piezoelectric material is configured to receive the electromagnetic frequency and move based on the received electromagnetic frequency.

9. The circulatory assist device according to claim 1, wherein the two or more chambers include a vibration material positioned therein.

10. The circulatory assist device according to claim 9, wherein the vibration material enhances vibration from a drive shaft.

11. The circulatory assist device according to claim 10, wherein the two or more chambers include a balloon configured to expand in response to fluid being supplied thereto.

12. A circulatory assist device for moving fluid through a target vein or artery, a stent cage sized and shaped to be disposed within a target artery or vein, an impeller positioned within the stent cage and configured to move fluid, and two or more chambers positioned proximal and distal to the impeller, the impeller being positioned between the two or more chambers. A circulatory assist device comprising two or more chambers.

13. The circulatory assist device according to claim 12, wherein the impeller includes a helical impeller.

14. A circulatory assist device, further comprising a sensor for receiving an electromagnetic frequency for controlling the impeller, the impeller according to claim 12.

15. The circulatory assist device according to claim 14, wherein the impeller is wirelessly connected to the sensor and configured to control the impeller in response to the received electromagnetic frequency.

16. The circulatory assist device according to claim 12, wherein each of the two or more chambers comprises a balloon containing a flexible material configured to vibrate at least partially based on movement of the impeller.

17. The circulatory assist device according to claim 16, wherein the flexible material is in an annular shape for passing a drive shaft therethrough.

18. The circulatory assist device according to claim 16, further comprising a piezoelectric material positioned within the two or more chambers.

19. The circulatory assist device according to claim 12, wherein each of the two chambers comprises a body portion and an attachment portion, the body portion having a teardrop shape and the attachment portion having an annular shape.

20. A circulatory assist device for placement within a patient's blood vessel, the circulatory assist device comprising: an impeller; at least a portion of a piezoelectric material and / or a vibration material, the piezoelectric material and / or the vibration material being configured to vibrate or resonate in response to the application of an electric field, an electromagnetic field, and / or a magnetic field. A circulatory assist device comprising at least a portion of a piezoelectric material and / or a vibration material.

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