Dynamic Drive System for Cardiac Systolic and Diastolic Assist

Abstract

A system and method for assisting a heart in pumping blood, wherein the heart has external force requirements that need to be externally applied to the heart using a cardiac assist device that is powered by a drive fluid. The cardiac assist device is powered by a drive fluid having a pressure/flow profile that is customized to the needs of the heart. The pressure/flow profile is generated by a displacement pump. If the pressure/flow profile requires pressures that cannot be made by the displacement pump, then the pressure/flow profile can be altered by venting pressure and/or adding pressurized fluid into the system. In this manner, a precise pressure/flow profile can be produced that meets the exact needs of a heart being acted upon by a cardiac assist device.

Claims

1. A system for assisting a heart in pumping blood, wherein the heart has external force requirements that need to be externally applied to the heart in order for the heart to pump more effectively, said system comprising: a drive fluid; a direct cardiac compression device capable of producing said external force requirements if powered by a drive fluid having a pressure/flow profile customized to said external force requirements of the heart; and a displacement pump that operates to produce at least part of said pressure/flow profile in said drive fluid.

2. The system according to claim 1, further including a vent valve for venting said drive fluid to ambient pressure as said displacement pump continues to operate.

3. The system according to claim 2, wherein said vent valve is a variable computer controlled valve.

4. The system according to claim 1, wherein said direct cardiac compression device has strain characteristics that combine with said pressure/flow profile to meet said external force requirements when said direct cardiac compression device is powered by said drive fluid.

5. The system according to claim 1, wherein said pressure/flow profile has a maximum pressure, a minimum pressure, and rates of pressure change between said maximum pressure and said minimum pressure.

6. The system according to claim 5, further including a vent valve for selectively venting said drive fluid to produce at least part of said pressure/flow profile in said drive fluid.

7. The system according to claim 6, wherein operation of said vent valve can selectively alter said minimum pressure, and at least one of said rates of pressure change in said pressure/flow profile.

8. The system according to claim 1, further including a pressurized fluid source for selectively pressurizing said drive fluid to produce at least part of said pressure/flow profile in said drive fluid.

9. A method for assisting a heart in pumping blood, wherein the heart has external force requirements that need to be externally applied to the heart in order for the heart to pump more effectively, said method comprising: providing a direct cardiac compression device capable of producing said external force requirements if powered by a drive fluid with a specific pressure/flow profile; placing said direct cardiac compression device in operational contact with the heart; and operating a displacement pump to produce at least part of said pressure/flow profile in said drive fluid.

10. The method according to claim 9, wherein said method includes providing a vent valve that can vent said drive fluid to ambient pressure as said displacement pump continues to operate.

11. The method according to claim 10, further including proving a variable computer control to said vent valve and said displacement pump.

12. The method according to claim 11, further including a drain line that maintains suction between said direct cardiac compression device and the heart, wherein said drain line has a detector that detects any loss of suction, wherein said detector directs said variable computer control to vary said vent valve to adjust said pressure/flow profile to compensate for the loss of suction.

13. The method according to claim 9, wherein said direct cardiac compression device has strain characteristics, and said pressure/flow profile is selectively produced in view of said strain characteristics to meet said external force requirements when said direct cardiac compression device is powered by said drive fluid.

14. The method according to claim 9, wherein said pressure/flow profile has a maximum pressure, a minimum pressure, and rates of pressure change between said maximum pressure and said minimum pressure.

15. The method according to claim 12, further including selectively venting said drive fluid to produce at least part of said pressure/flow profile in said drive fluid.

16. The method according to claim 14, wherein said selectively venting alters said minimum pressure, and at least one of said rates of pressure change in said pressure/flow profile.

17. A pump system for producing an acting pressure/flow profile in a drive fluid required to drive a direct cardiac compression device, said system comprising: a displacement pump for selectively pumping a drive fluid over time in a manner that provides said drive fluid with a first pressure/flow profile; and a vent for selectively venting said drive fluid to modify said pressure/flow profile into said acting pressure/flow profile.

18. The system according to claim 17, wherein said vent can vent said drive fluid to ambient pressure as said displacement pump is pumping.

19. The system according to claim 17 wherein said vent is at least one variable flow valve.

20. The system according to claim 17, further including a drain line that is monitored and is utilized to alter said acting pressure/flow profile when pressure in said drain line changes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] For a better understanding of the present invention, reference is made to the following description of exemplary embodiments thereof, considered in conjunction with the accompanying drawings, in which:

[0016] FIG. 1 is an exemplary schematic overview of the present invention cardiac assist system shown in conjunction with a heart;

[0017] FIG. 2 shows an example of a pressure/flow profile that may be required by a cardiac assist device;

[0018] FIG. 3 shows an example of the pressure/flow profile that can be produced by the displacement pump alone;

[0019] FIG. 4 shows a first optional modification to the cardiac assist system of FIG. 1; and

[0020] FIG. 5 shows a second optional modification to the cardiac assist system of FIG. 1.

DETAILED DESCRIPTION OF THE DRAWINGS

[0021] Although the present invention system and methodology can be embodied in many ways, only a few exemplary embodiments are illustrated. The exemplary embodiments are being shown for the purposes of explanation and description. The exemplary embodiments are selected in order to set forth some of the best modes contemplated for the invention. The illustrated embodiments, however, are merely exemplary and should not be considered a limitation when interpreting the scope of the appended claims.

[0022] Referring to FIG. 1, a cardiac assist system 10 is shown that uses a direct cardiac compression device 12 to apply external forces to a heart 11. The direct cardiac compression device 12 is used on a heart 11 that is injured, diseased and/or arrested. Although the heart 11 may be deficient in its ability to pump blood, the heart 11 may have a natural pumping rhythm. This can be determined by monitoring the heart 11 and/or reviewing previous scans of the heart 11. If the heart 11 is arrested and has no known history, the average rhythm for a heart of the size and patient type can be used. Accordingly, the heart 11 has synchronization requirements 13 that can be determined. The means to determine the synchronization requirements 13 are disclosed in U.S. Patent Application Publication No. 2022/0280771, the disclosure of which is incorporated into this application by reference.

[0023] The heart 11 is deficient or arrested in its pumping ability. As such, the heart 11 has external force requirements 15 that must be applied to the heart 11 during a pumping cycle in order for the heart 11 to pump blood to a degree sufficient to support life. The method for determining the external force requirements 15 of a particular heart are described in U.S. Pat. No. 11,383,067 and U.S. patent application Ser. No. 17/931,853, filed Sep. 13, 2022, the disclosures of which are incorporated into this application by reference.

[0024] In order to apply external forces to the heart 11, a direct cardiac compression device 12 is provided. The direct cardiac compression device 12 is customized to meet the needs of the heart 11. The direct cardiac compression device 12 contains elastomeric components that have various strain characteristics 17 that are designed to meet the external force requirements 15 of the heart 11. The manner of embodying specific strain characteristics 17 into a direct cardiac compression device, is disclosed in U.S. patent application Ser. No. 17/931,853 filed Sep. 13, 2022, and U.S. patent application Ser. No. 18/150,746 filed Jan. 5, 2023, the disclosures of which are incorporated into this application by reference.

[0025] The strain characteristics 17 embodied by the direct cardiac compression device 12 apply some inherent forces to the heart 11 by simply being in contact with the heart 11. If the direct cardiac compression device 12 is connected to a pneumatic or hydraulic drive that is turned off, the direct cardiac compression device 12 will be filled with a drive fluid 14 at ambient pressure. The mere presence of the drive fluid 14 in the direct cardiac compression device 12 will resist the expansion and/or contraction of the heart 11. In the present invention system 10, the inherent resistance of the direct cardiac compression device 12 is reduced to make the direct cardiac compression device 12 non-obligatory, as is later explained in more detail.

[0026] Although the direct cardiac compression device 12 applies some forces to the heart 11 that can be made non-obligatory, much greater forces are applied to the heart 11 when the direct cardiac compression device 12 is powered. The external forces applied by the direct cardiac compression device 12 must be carefully generated to meet the external force requirements 15 of the heart 11. This can only be accomplished by pneumatically or hydraulically powering the direct cardiac compression device 12 with the drive fluid 14. The pressure created in the drive fluid 14 varies with time throughout the pumping cycle of the heart 11. As such, the drive fluid 14 has a pressure/flow profile 16 that represents the pressure of the drive fluid 14 as it varies over the time (t) of a heart pumping cycle. The drive fluid 14 used to power the direct cardiac compression device 12 can be a gas, such as air or nitrogen, or a liquid, such as saline or distilled water. The pressure/flow profile 16 is created in the drive fluid 14 through the operation of a displacement pump 18.

[0027] The displacement pump 18 can either pressurizing the drive fluid 14 into the direct cardiac compression device 12 or draw the drive fluid 14 out of the direct cardiac compression device 12. The displacement pump 18 has a displacement chamber 22 that is filled with the drive fluid 14. The displacement chamber 22 can be a bellows, a piston chamber, or another such system with variable internal volume. The drive fluid 14 is either forced out of the displacement chamber 22 or drawn into the displacement chamber 22 by decreasing or increasing the internal volume of the displacement chamber 22. The decrease or increase in volume is controlled by a linear actuator 24, stepper motor, or other such mechanism that alters the internal volume of the displacement chamber 22.

[0028] Normally, the displacement pump 18 operates in a closed loop, wherein the volume of the drive fluid 14 in the cardiac assist system 10 remains constant during both the expansion and contraction of the heart 11. However, when needed, the cardiac drive system 10 can be changed to an open loop system, where the volume of the drive fluid 14 can be selectively varied. The displacement pump 18 is connected to the direct cardiac compression device 12 with a primary tube 30. The primary tube 30 can be connected to a vent/drain 34 at atmospheric pressure. Flow between the primary tube 30 and the vent/drain 34 is controlled by at least one variable valve 36. The valve 36 preferably has a variable flow rate that can be controlled by a computer controller 40. When the variable valve 36 is open, the pressure in the primary tube 30 moves toward ambient at a very rapid rate. The rate at which the pressure can change can be greater than that achievable by the displacement pump 18 alone. As such, the computer controller 40 can control the displacement pump 18 and simultaneously open/close the valve 36 to achieve pressure change rates in the pressure/flow profile 16 that may be required by the direct cardiac compression device 12, but are unachievable by the displacement pump 18 alone.

[0029] If the variable valve 36 vents to atmospheric pressure, no forces are applied to the heart 11 other than those inherent in the presence of the direct cardiac compression device 12. Furthermore, if the valve 36 is left open, the direct cardiac compression device 12 will not pneumatically or hydraulically resist the expansions and/or contractions of the heart 11. The resulting state is considered to be non-obligatory and can be useful when applying the direct cardiac compression device 12, removing the direct cardiac compression device 12, and/or testing the inherent strength of the heart 11 during a procedure.

[0030] Referring to FIG. 2 in conjunction with FIG. 1, an example of a pressure/flow profile 16 is shown. The pressure/flow profile 16 shows the changes in the pressure of the drive fluid 14 over time. These pressure changes are required by the direct cardiac compression device 12 to meet the external force requirements 15 and synchronization requirements 13 of the heart 11. The pressure/flow profile 16 calculated for a particular heart 11 can be indexed to various heart measures that include entire heart volume, ventricular muscle mass, ventricular volumes, the size of the heart, the thickness of the heart muscle, the degree of damage/disease effecting the heart and/or the location of such damage/disease on the heart.

[0031] As can be seen, the pressure/flow profile 16 contains a maximum pressure (P1.sub.max), a minimum pressure (P1.sub.min) and complex transition zones 20 therebetween. In the transition zones 20, the slope of the pressure/flow profile 16 represents the change in pressure over time (?P).

[0032] Referring to FIG. 3, in conjunction with FIG. 1 and FIG. 2, it can be seen that the displacement pump 18 by itself can generate a complex pressure/flow profile 25 by expanding and contracting. The pressure/flow profile 25 of the displacement pump 18 has a maximum pressure (P2.sub.max), a minimum pressure (P2.sub.min), and a maximum pressure change rate (?P2) that are all governed by the mechanics of the displacement pump 18. Comparing the needed pressure/flow profile 16 of FIG. 2 to the pressure/flow profile 25 of FIG. 3 being generated by the displacement pump, it can be seen that if the maximum pressure (P2.sub.max) and the maximum pressure change rate (?P2) in transition zones 27 are greater than or equal to those required by the pressure/flow profile 16 of the direct cardiac compression device 12, and the minimum pressure (P2.sub.min) is less than that required, then the displacement pump 18 alone is capable of producing the pressure/flow profile 16 needed to properly drive the direct cardiac compression device 12. However, due to the complexity of some pressure/flow profiles that may be required, the displacement pump 18 may be insufficient to produce the nuances of the pressure/flow profile 16 and may require pressure change rate assistance that can be accomplished by selectively controlling the variable valve 36.

[0033] If the displacement pump 18 runs most efficiently if operated in a regular cyclic pattern. Using the basic cyclic pressure changes, the variable valve 36 can be operated to provide more emphasis on either systolic or diastolic support. For example, if the variable valve 36 is open to atmospheric pressure during the compression phase of the heart's pumping cycle, the direct cardiac compression device 12 will have little impact on compression. However, if the variable valve 36 is closed at the onset of diastole, full effect can be applied to the filling of the heart 11. The opposite happens when the variable valve 36 is closed during compression and open during diastole, wherein little if any impact is provided to the filling of the heart 11.

[0034] When the variable valve 36 is open during either compression or diastole, it creates a non-obligatory condition. The same effect would occur if the primary tube 30 were detached and left open to atmospheric pressure. The displacement pump 18 can be left running in a smooth cyclic fashion while the valve 36 is open to provide rather discrete times when the drive has a lesser effect on the heart 11.

[0035] Although the pressure/flow profile 16 can be selectively controlled by dynamically venting/draining the drive fluid 14, additional control can be obtained by selectively adding drive fluid 14 to the system under pressure. Referring to FIG. 4, a modification is shown where the displacement pump 18 is connected to the direct cardiac compression device 12 with a primary tube 30. The primary tube 30 can be connected to a reservoir 52 of working fluid. The flow between the primary tube 30 and the source of working fluid is controlled by at least one variable fill valve 50. The fill valve 50 preferably has a variable flow rate that can be controlled by a computer controller 40. When the fill valve 50 is open, the pressure in the source of working fluid can be increased at a very rapid rate. The rate at which the pressure rises can be greater than that achievable by the displacement pump 18 alone. As such, the computer controller 40 can control the displacement pump 18 and simultaneously open the fill valve 50 to achieve a pressure increase rate in the pressure/flow profile 16 that may be required by the direct cardiac compression device 12, but is unachievable by the displacement pump 18 alone.

[0036] The displacement pump 18, the fill valve 50, and the vent valve 36 are all operated by the computer controller 40. The computer controller 40 runs dynamic operational software 44 that selectively controls the displacement pump 18, the fill valve 50, and the vent valve 36 in order to generate the pressure/flow profile 16 to a high degree of accuracy.

[0037] The direct cardiac compression device 12 is a device that surrounds a portion or all of the ventricles of the heart 11. Therefore, during its application and operation, the direct cardiac compression device 12 is likely provided with a drain that is connected to a suction source. This drain would communicate with the space between the heart surface and the cuff of the device. Referring to FIG. 5, a modification is shown where a drain line 60 is connected to the direct cardiac compression device 12. The drain line 60 leads to a suction source 62. The drain line 60 is used to remove any air, blood, and/or fluids that may accumulate between the heart 11 and the direct cardiac compression device 12. The drain line 60 also maintains a negative pressure between the heart 11 and the direct cardiac compression device 12 to help prevent the direct cardiac compression device 12 from separating from the heart 11 while operating.

[0038] The negative pressure between the heart 11 and the direct cardiac compression device 12 is slight. However, the negative pressure does have an effect on the heart 11. As such, the presence of suction can alter the optimal pressure/flow profile 16 that is being produced by the displacement pump 18. If the suction is consistently maintained, then the effect on the pressure/flow profile 16 is constant and can be readily compensated for in the pressure/flow profile 16. However, the suction between the heart 11 and the direct cardiac compression device 12 is subject to breaking as the heart 11 and the direct cardiac compression device 12 move and air or fluid is drawn into the interface. When air or fluid breaks the suction between the heart 11 and the direct cardiac compression device 12, the heart 11 can rebound until suction is reestablished. This can cause a momentary hitch in the forces the heart 11 needs to pump efficiently.

[0039] In the embodiment of FIG. 5, a pressure monitor 64 is provided in the drain line 60. The pressure monitor 64 detects the pressure in the drain line 60 and detects when suction between the heart 11 and the direct cardiac compression device 12 is broken. The pressure monitor 64 can be connected to the computer controller 40. As such, the computer controller 40 can control or pause the displacement pump 18 to compensate for the effects caused by the momentary loss of pressure. There may be times when a seal is formed between the device 12 and the heart 11 and the drain is not needed.

[0040] As is indicated in FIG. 5, if the direct cardiac compression device 12 has both a drain line 60 and the primary tube 30 for delivering the pressure/flow profile, both tubes can be interconnected in a section 66 that extends into the body. In this manner, the tubes take less space and are less likely to tangle with each other and other surgical instruments that may be in use.

[0041] Referring to all figures, it will be understood that, in use, the pressure/flow profile 16 needed to be generated by the displacement pump 18 is determined by the dynamic application software 44. The software can consider the strain characteristics 13 of the direct cardiac compression device 12 in use, the external force requirements 15 of the heart 11, and secondary heart factors. The secondary heart factors include, but are not limited to, heart size, heart volume, extent of heart damage, heart wall thicknesses, heart valve deficiencies, and neurological deficiencies. Once the variables are input, the dynamic application software 44 calculates the required pressure/flow profile 16. With the pressure/flow profile 16 determined, the computer controller 40 operates the displacement pump 18 to generate the pressures that match the pressure/flow profile 16 at any time (t) during the pumping cycle of the heart 11.

[0042] The pressure/flow profile 16 required for each heart and each direct cardiac compression device 12 is different. If a pressure/flow profile 16 at some time (t) requires a lower pressure or a decreasing rate of pressure that is unobtainable from the displacement pump 18, then the computer controller 40 can activate the vent valve 36 and vent pressure. This increases the overall rate of change in pressure and enables the requirements of the pressure/flow profile 16 to be met while still using a simple displacement pump 18.

[0043] The computer controller 40 can also operate the vent valve 36 with/without the displacement pump 18 to make rapid adjustments to the pressure/flow profile 16 should suction be compromised or lost between the heart 11 and the direct cardiac compression device 12.

[0044] Likewise, if a pressure/flow profile 16 at some time (t) requires a non-obligatory condition to evaluate the natural strength of the heart, then the vent valve 36 can be left open to eliminate all pressure, while the displacement pump 18 is still pumping. The fully vented non-obligatory condition can also be maintained when the direct cardiac compression device 12 is being installed, removed or when the heart is being evaluated with other stimuli, such as a pacemaker.

[0045] It will be understood that the embodiments of the present invention that are illustrated and described are merely exemplary and that a person skilled in the art can make many variations to those embodiments. All such embodiments are intended to be included within the scope of the present invention as defined by the claims.