CN117599330A - Balloon-based pump for heart assist - Google Patents

Abstract

The disclosed embodiments break the limitations of a single balloon pump of conventional systems. In some embodiments, three separate balloons may be used, with the balloon in the center pumping biological fluid and the balloons on both sides acting as valves. In some embodiments, a bladder in combination with two one-way valves may be used. In other example embodiments, multiple balloons may be used, where a subset of the balloons may be used as valves, and the remaining balloons may pump biological fluids, thereby creating a controllable ratio of upstream and downstream flows. In some embodiments, balloons having different thicknesses or made of different materials may be used for controlled inflation/deflation cycles. The novel pump disclosed herein is more adjustable compared to conventional pumps to precisely control pumping force. The novel pump may also generate a greater pumping force than conventional pumps.

Description

Balloon-based pump for heart assist

Technical Field

The present disclosure relates to balloon-based pumping devices, systems, and methods for pumping biological fluids within a tube. In some embodiments, the present disclosure relates to balloon-based pumps deployed to arteries to assist the natural pumping force of the human heart.

Background

The human cardiovascular system is based on the principle of active and continuous pumping. The chambers of the human heart undergo patterned systolic and diastolic cycles to generate pumping forces that push blood from the heart through the arteries to different parts of the body and pull blood from the different parts of the body back to the heart through the veins. This constant blood circulation ensures that the body cells are able to receive nutrients and oxygen and to process cellular waste and carbon dioxide.

This pumping process of the heart must maintain sufficient blood pressure for this constant blood circulation. For example, the blood pressure of a normal person is about 120mmHg (systolic pressure)/80 mmHg (diastolic pressure). The main factors affecting blood pressure include the degree of contraction of the heart, especially the left ventricle. Weakened or enlarged hearts (or hearts that are generally undergoing cardiogenic shock) may not develop sufficient stress, which poses a significant risk to vital organs and may even cause death. This risk may be for the heart itself, so that the heart may not receive nutrients and oxygen through the coronary arteries.

To assist the heart to maintain adequate blood pressure, intra-aortic balloon pump systems have been developed. These pumps typically have a single balloon at the end of the cardiac catheter. The balloon is inflated and deflated periodically to provide additional pumping force throughout the body and to maintain adequate blood circulation, such as by maintaining adequate blood pressure. However, existing intra-aortic balloon pump systems have some drawbacks. These systems cannot be adjusted with a desired level of precision, for example, to produce a certain amount of pumping force, and sometimes may produce a lower than desired pressure. Therefore, significant improvements to pumps are needed to assist the human heart.

Disclosure of Invention

The disclosed embodiments address the above-mentioned deficiencies and may also provide other solutions. In particular, embodiments break the limitations of a single balloon pump of conventional systems. In some example embodiments, three separate balloons may be used, with the balloon in the center pumping biological fluid and the balloons on both sides acting as valves. In some example embodiments, a bladder in combination with two one-way valves may be used. In other example embodiments, multiple balloons may be used, where a subset of the balloons may be used as valves, and the remaining balloons may pump biological fluids, thereby creating a controllable ratio of upstream and downstream flows. In still other example embodiments, balloons having different thicknesses or made of different materials may be used for controlled inflation/deflation cycles. Thus, the novel pump disclosed herein is more adjustable compared to conventional pumps, thereby precisely controlling pumping force. In addition, the novel pump may also generate a greater pumping force than conventional pumps.

In some embodiments, a system for delivering a fluid within a pipe is provided. The system may include a pump formed from a plurality of balloons. The system may further include a controller configured to: inflating a first balloon of the plurality of balloons to close a fluid passageway within the tube; inflating a second bladder of the plurality of bladders while maintaining inflation of the first bladder to push fluid in a first direction; and inflating a third balloon of the plurality of balloons to prevent backflow of the pushed fluid in a second direction opposite the first direction.

In some embodiments, a system for delivering a fluid within a pipe is provided. The system may include a pump formed from a bladder and at least two one-way valves configured to open or close based on fluid pressure. The system may further include a controller configured to: generating a first signal to inflate the balloon, thereby creating a high pressure zone within between the two one-way valves such that a first one of the two one-way valves is closed and a second one of the two one-way valves is open, wherein the inflated balloon pushes fluid in a first direction, and generating a second signal to deflate the balloon, thereby creating a low pressure zone within between the two one-way valves such that the first one-way valve is open and draws in fluid, and such that the second one-way valve remains closed to prevent backflow of the pushed fluid in a second direction opposite to the first direction.

In some embodiments, a system for delivering a fluid within a pipe is provided. The system may include a pump formed from a plurality of balloons. The system may further include a controller configured to: generating a first pressure in a first direction by: inflating a first set of the plurality of air bags to close the fluid passageway within the tube; inflating a second set of the plurality of air bags to push fluid in a first direction; generating a second pressure in a second direction opposite the first direction by: inflating a third set of the plurality of air bags to close the fluid passageway within the tube; and inflating a fourth set of the plurality of air cells to push fluid in the second direction.

In some embodiments, a system for delivering a fluid within a pipe is provided. The system may include a pump formed from a balloon. The system may also include a controller configured to inflate the airbag such that, due to the variable inflation nature of the airbag, a first portion of the airbag inflates before a second portion inflates, the sequential inflation of the first and second portions pushing fluid in a first direction.

In some embodiments, a system for delivering a fluid within a pipe is provided. The system may include a pump formed from at least two balloons including a first balloon that is significantly shorter than a second balloon, wherein the first balloon and the second balloon are made of different materials or of the same material having different hardness. The system may also include a controller configured to use the same pressure line to: inflating the first balloon to close the fluid passageway within the tube; and inflating the second bladder while maintaining inflation of the first bladder to push fluid in the first direction.

Drawings

FIG. 1 illustrates an example airbag pump system according to an example embodiment of the disclosure.

Fig. 2A-2B illustrate an example airbag pump system according to an example embodiment of the disclosure.

FIG. 3 illustrates an example airbag pump system according to an example embodiment of the disclosure.

FIG. 4 illustrates an example airbag pump system according to an example embodiment of the disclosure.

FIG. 5 illustrates an example airbag pump system according to an example embodiment of the disclosure.

FIG. 6 illustrates an example airbag pump system according to an example embodiment of the disclosure.

FIG. 7 illustrates an example airbag pump system according to an example embodiment of the disclosure.

FIG. 8 illustrates an example airbag pump system according to an example embodiment of the disclosure.

Detailed Description

Although this specification discloses several embodiments of pumps for blood vessels to assist the heart, this is merely an example use case and should not be considered limiting. That is, the embodiments disclosed herein are applicable to any type of biological tube or lumen that delivers any type of biological fluid. Furthermore, the embodiments disclosed herein can be applied to any type of non-biological system, for example, any type of tubing or piping for transporting non-biological fluids.

As described above, the disclosed embodiments overcome the limitations of conventional systems by using multiple balloons, valved balloons, and/or balloons with different wall thicknesses or made of different materials. Thus, a larger and more adjustable pumping force can be generated compared to conventional pumping (limited to using a single balloon made of a single material).

FIG. 1 illustrates an example airbag pump system 100 according to an example embodiment of the disclosure. The use of a balloon pump system in the aorta 130 is shown by way of example only and should not be considered limiting. That is, the principles of system 100 can be used in any type of pipe or tube that conveys any type of fluid. In addition, the components of the system 100 shown are merely illustrative, and systems with additional, alternative, or fewer numbers of components should be considered within the scope of the present disclosure.

In general, the pump system 100 includes a pump 102, a conduit 122, and a controller 108. Pump 102 is deployed to aorta 130 using catheter 122. For example, multiple balloons, stents, and/or valves within the pump 102 may be in a contracted state at the end of the catheter 122 (e.g., the balloons may be in a deflated state). The catheter 122 may be advanced through an artery in the groin or shoulder area of the patient (e.g., by radial insertion). Once the pump 102 reaches a desired location, such as the descending bow of the aorta 130, the pump 102 may be ready for use. One or more control lines 116 from the controller 108 to the pump 102 may send pump commands and/or drive fluid to operate the pump 102. The driving fluid may include any type of fluid including, but not limited to, helium, compressed air, saline, water, low viscosity oil, and the like. Pump 102 may include a plurality of balloons made of any type of material (e.g., elastomeric, woven, etc.). The balloon may be thin but fatigue resistant.

In some embodiments, the controller may also include and/or be associated with an electrocardiogram (ECG, also known as EKG). ECG measures the electrical signals generated in the heart during atrial and ventricular contractions of the heart. To assist the pumping force generated by the heart, the controller 108 may synchronize the operation of the pump 102 based on the ECG signal. For example, the midpoint of the T wave in the ECG signal may trigger the pumping force in the pump 102, and the peak of the R wave in the ECG signal may trigger the relaxation of the pumping force in the pump 102.

In some embodiments, the controller 108 may not use an ECG signal that controls the pump 102. There may be situations where the ECG signal is not available or other situations where the ECG signal is not reliable. In these cases, artificial intelligence techniques may be used to simulate the ECG signals, and these simulated ECG signals may be used by the controller 108. In these embodiments, the simulated ECG signal may be based on demographic factors of the patient (e.g., age, gender, blood pressure, etc.) and/or based on general mass characteristics of the patient population. Thus, a simulated ECG signal will be understood to be generated by coarsely estimating the true ECG signal of the patient's heart using arbitrary training data and/or modeling. In some embodiments, the balloon pump system 100 may include one or more pressure sensors (described in embodiments below), and the controller may use the measurements of the pressure sensors to generate control signals and/or control the drive fluid.

Operation of pump 102 may be used to create flow in any direction. For example, pump 102 may push blood in the direction of heart push, i.e., assist the heart in pumping blood throughout the atrial system. In other examples, pump 102 may push blood upstream, e.g., to the coronary arteries. In still other examples, pump 102 may form a mixture of upstream and downstream flows in a predetermined ratio, e.g., downstream: the upstream ratio is → 3:1.

The following description discloses several embodiments of the pump system 100. These several embodiments may be used in combination or as an alternative. In addition, not all of the components of the described embodiments may be used. Thus, any type of system based on the principles of the embodiments should be considered to be within the scope of the present disclosure.

Fig. 2A-2B illustrate an example airbag pump system 200 according to an example embodiment of the disclosure. In some embodiments, the balloon pump system 200 is based on a multiple balloon design. Fig. 2A shows an example of an airbag pump system 200 that includes three airbags 202, 204, and 206, wherein a controller 208 controls respective inflation, maintenance (i.e., maintains respective inflation), and deflation. That is, the controller 208 sends control signals and/or drive fluid (e.g., compressed helium) via control line 216 for controlled sequential inflation, maintenance, and deflation of the balloons 202, 204, and 206 to create a flow of biological fluid (e.g., blood) from the inflow 210 to the outflow 212 via the tube 214 (e.g., a blood vessel). As described above, the controller 208 may generate control signals and/or control the drive fluid based on ECG signals or stored non-ECG signals. In some embodiments, the balloon pump system may include pressure sensors 240, 242 to measure the pressure of the biological fluid within the tube 214. However, it should be understood that the location and number of pressure sensors 240, 242 are provided by way of example only and should not be considered limiting. Any number of pressure sensors at any location should be considered to be within the scope of the present disclosure.

In some embodiments, the tube may be about 8-30mm in diameter, the balloons 202, 206 may be about 5-30mm in width (i.e., in the direction of flow of the biological fluid), and the balloon 204 may be about 2-30cm in width (also in the direction of flow of the biological fluid). However, these dimensions are provided as non-limiting examples only, and other dimensions may be used without departing from the principles disclosed herein. In general, the length of the balloons 202, 206 may be equal or similar, but the balloon 204 may be significantly longer.

Fig. 2B illustrates an example of controlled sequential inflation, retention, and deflation of the bladders 202, 204, and 206, as described below. Typically, the balloons 202 and 206 at both ends (i.e., the upstream end with the inflow 210 and the downstream end with the outflow 212) act as valves, while the middle balloon 204 acts as a fluid pusher.

At step 250, pumping begins when tube 214 is filled with fluid, such as when ventricular contractions cause blood to flow through tube 214. At this stage, all of the bladders 204, 202, and 206 are inflated, which may be an initial cycle of the pump system 200 or may be the beginning of the next pump cycle after a previous pump cycle.

At step 252, the controller 208 inflates the balloon 206 to close the fluid passageway in the tube 214. Thus, the inflated bladder 206 acts as a valve to prevent backflow of biological fluid toward the inflow site 210 when the bladder pump system 200 pumps the biological fluid toward the outflow site 212. In some embodiments, the controller 208 may inflate and deflate one or more of the balloons 202, 204, and 206 based on the respective pressures measured by the pressure sensors 240, 242 or EKG signals.

At step 254, the controller 208 inflates the balloon 204, which pushes the biological fluid toward the outflow 212 (because the balloon 206 is still inflated and acts as a valve, inflation of the balloon 204 cannot push the biological fluid toward the inflow 210).

In step 256, the controller inflates the balloon 202 to prevent backflow of biological fluid toward the inflow 210. In some embodiments, the controller 208 may inflate both the balloon 202 and the balloon 204 simultaneously. In other embodiments, the controller 208 may inflate the airbag 202 after inflating the airbag 204. Regardless of the relative time of inflation, the balloon 202 acts as a valve to prevent backflow of biological fluid forced toward the outflow 212 by the pumping action of the balloon 202. After this pump cycle is completed (i.e., balloon 206 is inflated- →balloon 204 is inflated while balloon 206 is being held- →balloon 202 is being inflated while balloons 204 and 206 are being held), balloons 204 and 206 are being deflated while balloon 202 is being held (balloon 202 may be slightly deflated in some embodiments). This combination creates a low pressure zone so that biological fluid can be absorbed at inflow 210, thereby filling tube 214. Once the tube 214 is filled, the controller 208 returns to step 250 to begin the next pump cycle.

In addition, the controller 208 may control the flow of the biological fluid in two directions, that is, in a first direction from the inflow 210 to the outflow 212 and in a second direction from the outflow 212 to the inflow 210. For example, the controller 208 may perform the reversal of inflation and deflation of the airbags 202, 204, and 206 described above to generate flow in the second direction. Control of flow in both directions may facilitate the stirring, mixing and/or compounding functions of the biological fluid. For example, the controller 208 may generate flow in a first direction during one cycle and then generate flow in a second direction during another cycle. The combination of bi-directional flows may also be based on the respective pressures measured by the pressure sensors 240, 242.

FIG. 3 illustrates an example airbag pump system 300 according to an example embodiment of the disclosure. In some embodiments, the airbag pump system 300 is based on a single airbag multiple valve design. In the example shown, the balloon pump system 300 includes a balloon 304 and one-way valves 302, 306, wherein a controller 308 controls inflation, maintenance, and deflation of the balloon 304. In some embodiments, the check valves 302, 306 may be passive and thus open and close based on a pressure differential created by inflation or deflation of the bladder 304. In other embodiments, the check valves 302, 306 may be active, and the controller may open or close (e.g., electrically) the check valves 302, 306 by sending a signal. It may be noted that the one-way valves 302, 306 may be similar to the balloons 202, 206 of the balloon pump system 200 described above. The controller 308 sends signals and/or drive fluid via control lines 316 to control the inflation, maintenance, and deflation of the bladder 304, and in the embodiment of the active check valves 302, 306, to control the opening and closing of the check valves 302, 306. Controlled operation of the bladder 304 and the one-way valves 302, 306 may create a flow of biological fluid from the inflow 310 to the outflow 312 through the tube 314. Balloon pump system 300 also includes a sheath 318 and a tube 314, which forms a protective barrier between balloon 304 and one-way valves 302, 306. Additionally, jacket 318 may be used to provide structural support for tube 314. Sheath 318 may be understood to include a flexible sheath, a stent, a covered stent, and/or any other type of structure that encloses the moving components of balloon pump system 300.

As described above, the controller 308 may generate control signals and/or control the drive fluid based on ECG signals or stored non-ECG signals. In some embodiments, the balloon pump system may include pressure sensors 340, 342 to measure the pressure of the biological fluid within the tube 314. However, it should be understood that the location and number of pressure sensors 340, 342 are provided by way of example only and should not be considered limiting. Any number of pressure sensors at any location should be considered to be within the scope of the present disclosure.

Example operation of the airbag pump system 300 may be as follows. The pumping cycle begins when the tube 314 is filled with biological fluid, such as when a ventricular contraction causes blood to flow through the tube 314. The controller 308 inflates the balloon 304 to create pressure that pushes biological fluid toward the outflow 312, opens the one-way valve 302, and closes the one-way valve 306 (because the one-way valve 306 is closed, inflation of the balloon 304 cannot push fluid toward the inflow 310). The controller 308 then deflates the bladder 304 to release the pressure, and the deflates closes the check valve 302 and opens the check valve 306. The pressure relief caused by the deflation of the bladder 304 and the opening of the valve 306 creates a low pressure region that creates an inhalation force in the direction of the outflow 312. Once the tube 314 is filled by suction, the next pump cycle may begin.

FIG. 4 illustrates an example airbag pump system 400 according to an example embodiment of the disclosure. In some embodiments, the balloon pump system 400 may be based on a multiple balloon design (e.g., including at least four balloons). In the example shown, the airbag pump system 400 includes seven airbags 402a-402g, wherein the controller 408 controls the respective inflation, maintenance (i.e., maintains the respective inflation), and deflation. That is, the controller 408 sends control signals via lines and/or sends a driving fluid (e.g., compressed helium) via control line 416 for controlled sequential inflation, maintenance, and deflation of the balloons 402a-402g to create a flow of biological fluid (e.g., blood) from the inflow 410 to the outflow 412 via the tube 414 (e.g., blood vessel). In some embodiments, the size of the bladders 402a-402g may be equal. In other embodiments, the size of the balloons 402a-402g may be different, for example, a smaller balloon may be used as a valve and a larger balloon may be used as a fluid pusher.

As described above, the controller 408 may generate control signals and/or control the drive fluid based on ECG signals or stored non-ECG signals. In some embodiments, the balloon pump system may include pressure sensors 440, 442 to measure the pressure of the biological fluid within tube 414. However, it should be understood that the locations and number of pressure sensors 440, 442 are provided by way of example only and should not be considered limiting. Any number of pressure sensors at any location should be considered to be within the scope of the present disclosure.

Examples of controlled sequential inflation, retention, and deflation of the bladders 402a-402g may be as follows. The controller 408 may assign the air bags 402g, 402e, and 402a as valves (in some embodiments, the air bags assigned as valves may be smaller than the remaining air bags, while in other embodiments, the air bags may be similar or the same in size). In this multiple valve arrangement, the air bags 402e, 402f may push the biological fluid in a direction opposite the inflow 410, while the air bags 402c, 402d, and 402e may push the biological fluid toward the outflow 412. The use of multiple air bags 402a-402g may then help create flow in both directions in a predefined controlled ratio. For example, in the foregoing arrangement, the ratio of the amount of biological fluid between the downstream direction (i.e., from the inflow 410 to the outflow 412) and the upstream direction is 3:1.

Another example of controlled sequential inflation, retention, and deflation of the bladders 402a-402g may be as follows. In this example, the controller 408 may assign the airbags 402g, 402d, and 402a as valves (the airbag operating as a valve is changed from 402e to 402d as compared to the previous example). In this example, the controller may control the airbags 402d-402f to push the biological fluid upstream and control the airbags 402b-402d to push the biological fluid downstream. The pushing may produce an amount of biological fluid in both directions.

Thus, any ratio of upstream to downstream flow may be generated using the airbag pump system 400. For example, a downstream flow may be generated to maintain sufficient pressure on the downstream aorta, and an upstream flow may be generated to maintain sufficient pressure on the upstream blood vessel (e.g., for the aortic branch of the upper part of the body). Alternatively, an upstream flow may be generated to push aortic blood toward the coronary arteries.

The controller 408 may sequence downstream pumping and upstream pumping. For example, the controller 408 may alternate between downstream pumping and upstream pumping every cycle, every other cycle, or between a predetermined number of cycles. In some embodiments, the balloon pump system 400 may include pressure sensors 440, 442, and the controller may control the balloons 402a-402g based on the respective pressures measured by the pressure sensors 440, 442.

Fig. 5 illustrates an example airbag pump system 500 according to an example embodiment of the disclosure. In some embodiments, balloon pump system 500 may be based on a single balloon design with different wall thicknesses. In the example shown, the balloon pump system 500 has a single balloon 502 with a wall 520 having a thickness that gradually increases in the downstream direction (i.e., from the inflow 510 to the outflow 512). When the controller 508 activates the balloon 502, the balloon 502 is gradually inflated: the portion with the thinner wall (in the upstream direction) is inflated first compared to the portion with the thicker wall (in the downstream direction). This aeration from the upstream direction to the downstream direction causes the biological fluid to flow from the upstream direction to the downstream direction. During the deflation, the portion having the thin wall is deflated first as compared to the portion having the thick wall. This type of deflation causes the low pressure region in the balloon to draw in biological fluid from an upstream direction to a downstream direction.

As described above, the controller 508 may generate control signals and/or control the drive fluid based on ECG signals or stored non-ECG signals. In some embodiments, the balloon pump system may include pressure sensors 540, 542 to measure the pressure of the biological fluid within the tube 514. However, it should be understood that the location and number of pressure sensors 540, 542 are provided by way of example only and should not be considered limiting. Any number of pressure sensors at any location should be considered to be within the scope of the present disclosure. As shown, the controller 508 may use control lines 516 for control signals and/or drive fluids.

Although this embodiment is described in terms of balloons 502 having walls 520 of different thicknesses, any kind of balloons that exhibit similar inflation and deflation behavior should be considered within the scope of the present disclosure. For example, different portions of the balloon may be made of different materials, with a first material having properties that cause slower inflation and deflation and a second material having properties that cause faster inflation and deflation. As another example, the bladder 502 may be made of the same material, but may have different durometers such that one side inflates and deflates faster than the other side.

Fig. 6 illustrates an example airbag pump system 600 according to an example embodiment of the disclosure. In some embodiments, the balloon pump system 600 is based on a multiple balloon design. The illustrated example of an airbag pump system 600 includes two airbags 602 and 604, wherein a controller 608 controls respective inflations, maintains (i.e., maintains) and deflates. That is, the controller 608 sends control signals and/or drive fluid (e.g., compressed helium) through the control line 616 for controlled sequential inflation, maintenance, and deflation of the balloons 602 and 604 to create a flow of biological fluid (e.g., blood) from the inflow 610 to the outflow 612 through the tube 614 (e.g., blood vessel). The balloons 602 and 604 may be made of different materials or the same material with different hardness to vary the response time of the balloons.

In particular, the airbags 602 and 604 may be inflated using the same pressure/vacuum line (i.e., within the control line 616) such that the airbags 602 and 604 begin to inflate simultaneously. However, the volume of balloon 604 may be significantly smaller than the volume of balloon 602. Thus, bladder 604 may be inflated first and act as a valve. Balloon 602 may continue to inflate to push biological fluid downstream. During deflation, bladder 604 may be pre-deflated to form a low pressure zone that draws in biological fluid from inflow 610 and may begin the pumping cycle again.

In some embodiments, the inflation lumen (not shown) may terminate in a smaller balloon 604. Another smaller lumen may then connect smaller balloon 604 to larger balloon 602. Thus, with the same pressure/vacuum lines, the smaller balloon 604 may be inflated or deflated earlier than the larger balloon. In some embodiments, balloons 602 and 604 may be made of different materials to have different inflation characteristics. In other embodiments, balloons 602 and 604 may be made of the same material but with different durometers to have different expansion characteristics.

As described above, the controller 608 may generate control signals and/or control the drive fluid based on ECG signals or stored non-ECG signals. In some embodiments, the balloon pump system may include pressure sensors 640, 642 to measure the pressure of the biological fluid within the tube 614, and the controller 608 may generate control signals and/or control the drive fluid based on measurements from the pressure sensors 640, 642. However, it should be understood that the location and number of pressure sensors 640, 642 are provided by way of example only and should not be considered limiting. Any number of pressure sensors at any location should be considered to be within the scope of the present disclosure.

Fig. 7 illustrates an example airbag pump system 700 according to an example embodiment of the disclosure. Balloon pump system 700 may include separate balloon pumps 702a and 702b controlled by controller 708 through control lines on conduit 722. As shown, balloon pump 702a may be placed on the downstream portion of aorta 730, while balloon pump 702b may be placed on the upstream vessel. The use of different balloon pumps 702a and 702b at separate locations may facilitate the coordinated triggering of the pumps at different times to generate sufficient pressure in the two vessels. As shown, the controller 708 may use control lines 716 to control signals and/or drive fluids.

Fig. 8 illustrates an example airbag pump system 800 according to an example embodiment of the disclosure. As shown, the balloon pump system 800 includes three balloons: a bladder 802 that acts as a valve, a bladder 804 that generates the primary pumping force, and a bladder 806 that acts as a valve. The valve-pumping force-valve configuration of the bladders 802, 804, and 806 are merely examples, and any of the bladder, valve, protective sheath embodiments described above are applicable to the bladder pump system 800. In addition, balloon pump system 800 may include additional components as in the embodiments described above. Further, the airbag pump system 800 may operate as in any of the embodiments described above.

The balloon pump system 800 features the use of protective balloon cuffs 830, 832. The balloon cuffs 830, 832 may protect the aortic wall from dissection induced by cyclic inflation and deflation of the underlying balloon (e.g., balloons 802, 806) or underlying valves. In some embodiments, the balloon cuffs 830, 832 may be made of annular balloons. The annular balloons may be in a deflated state as they are advanced through the catheter, and then may be inflated when they reach the desired location. However, the use of a ring balloon is merely an example and should not be considered limiting. Any kind of protective/cuff mechanism that protects the aortic wall from incision caused by the cyclic inflation and deflation actions of the underlying balloon should be considered within the scope of the present disclosure. In some embodiments, to allow for the accommodation of balloon cuffs 830, 832, the underlying balloon (e.g., balloons 802, 806) may have a smaller outer diameter than a balloon without such balloon cuffs 830, 832.

The foregoing is considered as illustrative only of the principles of the invention. The embodiments disclosed herein are merely illustrative of the invention, which may be embodied in other specific structures. Although embodiments have been described, the details may be changed without departing from the invention. Furthermore, most of the invention is shown in simplified form to illustrate the basic functions and features, and may be combined into a final embodiment using one or more elements combined into a single device. Further, since numerous modifications and changes will readily occur to those skilled in the art, the invention is not limited to the exact construction and operation shown and described in the preferred embodiments, except as indicated by the claims.

Although the invention has been described with reference to the foregoing disclosure, it is to be understood that modifications and variations are within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.

It should be noted that the terms "comprising" and "including" should be construed as "including but not limited to". The terms "a" and "an" should be interpreted as "at least one", "the" and the like are to be construed as "the at least one", and the like, if not explicitly stated in the claims. Furthermore, it is the intention of the applicant that only the claims comprising the explicit language "for something" or "for something" be interpreted in accordance with 35u.s.c.112 (f). Claims that do not explicitly include the phrase "means for something" or "steps for something" are not to be construed in accordance with 35u.s.c.112 (f).

Claims (55)

1. A system for delivering a fluid within a pipe, comprising:

a pump formed of a plurality of air bags;

and a controller configured to:

inflating a first balloon of the plurality of balloons to close a fluid passageway within the tube;

inflating a second balloon of the plurality of balloons while maintaining inflation of the first balloon to push the fluid in a first direction; and

a third balloon of the plurality of balloons is inflated to prevent backflow of the pushed fluid in a second direction opposite the first direction.

2. The system of claim 1, wherein the controller is further configured to:

simultaneously inflating the second and third airbags.

3. The system of claim 1, wherein the controller is further configured to:

the third airbag is inflated after the second airbag is inflated.

4. The system of claim 1, wherein the controller is further configured to:

the first bladder and the second bladder are deflated while maintaining inflation of the third bladder to create a low pressure zone to pull the fluid in the first direction.

5. The system of claim 4, wherein the controller is further configured to:

after pulling the fluid in the first direction:

inflating the first balloon;

deflating the third balloon;

and inflating the second balloon to push the fluid in the first direction.

6. The system of claim 1, wherein the second balloon has a longer length than each of the first balloon and the second balloon.

7. The system of claim 1, wherein the first balloon and the third balloon are equal in length.

8. The system of claim 1, wherein to push the fluid in the second direction, the controller is further configured to:

inflating the third bladder to close the fluid passageway within the tube;

inflating the second balloon while maintaining inflation of the third balloon to push the fluid in the second direction;

and inflating the first balloon to prevent backflow of the pushed fluid in the first direction.

9. The system of claim 1, wherein the controller is further configured to control the flow of the fluid in the first direction and the second direction to form a stirring, mixing, and/or compounding function of the fluid.

10. The system of claim 1, wherein the tube comprises a human blood vessel and the fluid comprises human blood.

11. The system of claim 10, wherein the human blood vessel comprises a descending aorta.

12. The system of claim 1, wherein the controller is configured to inflate or deflate the respective balloon based on an electrocardiogram signal.

13. The system of claim 1, wherein the controller is configured to inflate or deflate the respective balloon based on the stored non-electrocardiographic signal.

14. The system of claim 1, further comprising:

one or more pressure sensors within the tube, wherein the controller is further configured to inflate or deflate the respective balloon based on the respective pressures measured by the one or more pressure sensors.

15. The system of claim 1, further comprising:

a balloon cuff surrounding at least one balloon of the plurality of balloons and configured to protect an aortic wall from incisions induced by the inflation and deflation cycles of the at least one balloon.

16. A system for delivering a fluid within a pipe, comprising:

a pump formed by a bladder and at least two one-way valves configured to open or close based on fluid pressure;

a controller configured to:

generating a first signal to inflate the balloon, thereby creating a high pressure region within between the two one-way valves such that a first one of the two one-way valves is closed and a second one of the two one-way valves is open, wherein the inflated balloon pushes the fluid in a first direction;

and generating a second signal to deflate the balloon, thereby creating a low pressure zone within the two one-way valves, such that the first one-way valve opens and draws in the fluid, and such that the second one-way valve remains closed to prevent backflow of the pushed fluid in a second direction opposite to the first direction.

17. The system of claim 16, wherein the pump is inserted into a sheath within the tube.

18. The system of claim 16, wherein the pump is inserted into a stent within the tube.

19. The system of claim 16, wherein the tube comprises a human blood vessel and the fluid comprises human blood.

20. The system of claim 19, wherein the human blood vessel comprises a descending aorta.

21. The system of claim 16, wherein the controller is configured to inflate or deflate the balloon based on an electrocardiogram signal.

22. The system of claim 16, wherein the controller is configured to inflate or deflate the balloon based on the stored non-electrocardiographic signal.

23. The system of claim 16, further comprising:

one or more pressure sensors within the tube, wherein the controller is further configured to inflate or deflate the balloon based on the respective pressures measured by the one or more pressure sensors.

24. The system of claim 16, further comprising:

a balloon cuff surrounding the at least one-way valve and configured to protect the aortic wall from incisions induced by the opening and closing of the at least one-way valve.

25. A system for delivering a fluid within a pipe, comprising:

a pump formed of a plurality of air bags;

a controller configured to:

generating a first pressure in a first direction by:

inflating a first set of the plurality of air bags to close a fluid passageway within the tube;

inflating a second set of the plurality of air cells to push the fluid in the first direction;

generating a second pressure in a second direction opposite the first direction by:

inflating a third set of air bags of the plurality of air bags to close the fluid passageway within the tube;

and inflating a fourth set of the plurality of air cells to push the fluid in the second direction.

26. The system of claim 25, wherein the controller is configured to generate the first pressure and the second pressure every alternate pumping cycle.

27. The system of claim 25, wherein the controller is configured to alternate between generating the first pressure and generating the second pressure between a predetermined number of pumping cycles.

28. The system of claim 25, wherein the controller is configured to generate the first pressure and the second pressure to form a stirring, mixing, and/or compounding function of the fluid.

29. The system of claim 25, wherein the tube comprises a human blood vessel and the fluid comprises human blood.

30. The system of claim 29, wherein the human blood vessel comprises a descending aorta.

31. The system of claim 25, wherein the controller is configured to inflate the respective balloon based on an electrocardiogram signal.

32. The system of claim 25, wherein the controller is configured to inflate the respective balloon based on the stored non-electrocardiographic signal.

33. The system of claim 25, further comprising:

one or more pressure sensors within the tube, wherein the controller is further configured to inflate the respective bladders based on the respective pressures measured by the one or more pressure sensors.

34. The system of claim 25, further comprising:

a balloon cuff surrounding at least one balloon of the plurality of balloons and configured to protect an aortic wall from incisions induced by the inflation and deflation cycles of the at least one balloon.

35. A system for delivering a fluid within a pipe, comprising:

a pump formed by an air bag;

and a controller configured to inflate the airbag, the airbag having variable inflation properties such that a first portion of the airbag inflates before a second portion inflates, sequential inflation of the first and second portions pushing the fluid in a first direction.

36. The system of claim 35, wherein the controller is further configured to:

the first portion is deflated while maintaining inflation of the second portion to create a low pressure region, thereby pulling the fluid in the first direction.

37. The system of claim 36, wherein the controller is further configured to:

after pulling the fluid in the first direction, the first portion is inflated in sequence and then the second portion is inflated to push the fluid in the first direction.

38. The system of claim 35, wherein the variable inflation property is provided by a variable thickness of the balloon wall.

39. The system of claim 35, wherein the variable inflation property is provided by balloon walls formed of different materials.

40. The system of claim 35, wherein the variable inflation property is provided by balloon walls formed of the same material having different hardness.

41. The system of claim 35, wherein the tube comprises a human blood vessel and the fluid comprises human blood.

42. The system of claim 41, wherein the human blood vessel comprises a descending aorta.

43. The system of claim 35, wherein the controller is configured to inflate or deflate the balloon based on an electrocardiogram signal.

44. The system of claim 35, wherein the controller is configured to inflate or deflate the balloon based on the stored non-electrocardiographic signal.

45. The system of claim 35, further comprising:

one or more pressure sensors within the tube, wherein the controller is further configured to inflate or deflate the balloon based on the respective pressures measured by the one or more pressure sensors.

46. The system of claim 35, further comprising:

a balloon cuff surrounding the balloon and configured to protect an aortic wall from dissection induced by the inflation and deflation cycles of the balloon.

47. A system for delivering a fluid within a pipe, comprising:

a pump formed from at least two balloons, the at least two balloons including a first balloon that is significantly shorter than a second balloon, wherein the first balloon and the second balloon are made of different materials or are made of the same material having different hardness;

and a controller configured to use the same pressure line to:

inflating the first balloon to close the fluid passageway within the tube;

and inflating the second balloon while maintaining inflation of the first balloon to push the fluid in a first direction.

48. The system of claim 47, wherein the controller is further configured to:

the first bladder is deflated while maintaining inflation of the second bladder to create a low pressure zone to pull the fluid in the first direction.

49. The system of claim 48, wherein the controller is further configured to:

after pulling the fluid in the first direction:

inflating the first balloon;

and inflating the second balloon to push the fluid in the first direction.

50. The system of claim 47, wherein the tube comprises a human blood vessel and the fluid comprises human blood.

51. The system of claim 50, wherein the human blood vessel comprises a descending aorta.

52. The system of claim 47, wherein the controller is configured to inflate or deflate the respective balloon based on an electrocardiogram signal.

53. The system of claim 47, wherein the controller is configured to inflate or deflate the respective balloon based on the stored non-electrocardiographic signal.

54. The system as recited in claim 47, further comprising:

one or more pressure sensors within the tube, wherein the controller is further configured to inflate or deflate the respective balloon based on the respective pressures measured by the one or more pressure sensors.

55. The system as recited in claim 47, further comprising:

a balloon cuff surrounding at least one balloon and configured to protect an aortic wall from dissection induced by the inflation and deflation cycles of the at least one balloon.