INTRA-AORTIC DUAL BALLOON DRIVING PUMP CATHETER DEVICE

Abstract

An intra-aortic dual balloon driving pump catheter device is disclosed, including a controlling part adapted to control air pumps to inflate and deflate a first balloon and a second balloon according to a cardiac cycle and an arterial pressure of the catheter end monitored by a monitoring part, such that in diastole the first balloon inflates while the second balloon deflates, and in systole the first balloon deflates while the second balloon inflates, wherein the second balloon deflates and inflates conversely to the synchronized inflation and deflation of the first balloon respectively, the first balloon fully inflates in diastole and fully deflates in systole, and the second balloon fully deflates in diastole and can inflate in systole only to a predetermined percentage of its volume of full inflation.

Claims

1. An intra-aortic dual balloon driving pump catheter device, comprising: a catheter; a first balloon and a second balloon, respectively surrounding the catheter, being arranged successively along a longitudinal direction of the catheter, wherein the first balloon is a counterpulsation balloon, being placed at a distal end of the catheter, and the second balloon is a valve balloon, being placed adjacent to a proximal end of the first balloon and is closer to the proximal end of the catheter than the first balloon; a monitoring part, for monitoring a cardiac cycle and an arterial pressure of the distal end; air pumps, respectively associated with the first balloon and the second balloon, for supplying and withdrawing air; a first intake pipe and a second intake pipe, each having a first end and a second end, the first ends of the first intake pipe and the second intake pipe being in communication with the first balloon and the second balloon respectively, and the second ends of the first intake pipe and the second intake pipe being in communication with the respectively associated air pumps; a controlling part, adapted to control the air pumps to inflate and deflate the first balloon and the second balloon according to the cardiac cycle and the arterial pressure of the distal end monitored by the monitoring part, wherein in diastole the first balloon inflates while the second balloon deflates, and in systole the first balloon deflates while the second balloon inflates, wherein the second balloon deflates and inflates conversely to the synchronized inflation and deflation of the first balloon respectively, and wherein the first balloon fully inflates in diastole and fully deflates in systole, and the second balloon fully deflates in diastole and inflates in systole only to a predetermined percentage of its volume of full inflation.

2. The intra-aortic dual balloon driving pump catheter device according to claim 1, wherein, after the intra-aortic dual balloon driving pump catheter device is set in an aorta, the second balloon first fully inflates, and the controlling part then adjusts a percentage of a volume of the inflated second balloon in relation to its volume of full inflation.

3. The intra-aortic dual balloon driving pump catheter device according to claim 2, wherein, after the intra-aortic dual balloon driving pump catheter device is set in the aorta, the controlling part adjusts the percentage of the volume of the inflated second balloon in relation to its volume of full inflation based on a supportive effect on circulatory failure suggested by clinical feedback.

4. The intra-aortic dual balloon driving pump catheter device according to claim 3, wherein the controlling part sets the percentage of the volume of the inflated second balloon in relation to its volume of full inflation based on an arterial pressure monitored by the monitoring part and the supportive effect on circulatory failure suggested by clinical feedback.

5. The intra-aortic dual balloon driving pump catheter device according to claim 1, wherein a number of discrete numerical points are preset in the controlling part as options for values to be taken when adjusting the percentage of the volume of the inflated second balloon in relation to its volume of full inflation.

6. The intra-aortic dual balloon driving pump catheter device according to claim 5, wherein interval steps between each adjacent pair of the discrete numerical points are identical.

7. The intra-aortic dual balloon driving pump catheter device according to claim 6, wherein the interval step is 5% at least.

8. The intra-aortic dual balloon driving pump catheter device according to claim 6, wherein the volume of the inflated second balloon is set to one of 100%, 75%, 50%, 25%, 0% of its volume of full inflation.

9. The intra-aortic dual balloon driving pump catheter device according to claim 6, wherein the volume of the inflated second balloon is set to one of 100%, 85%, 65%, 35% or 0% of its volume of full inflation.

10. The intra-aortic dual balloon driving pump catheter device according to claim 1, wherein a continuous range of numerical values are predetermined in the controlling part as a range of values to be taken when adjusting the percentage of the volume of the inflated second balloon in relation to its volume of full inflation.

11. The intra-aortic dual balloon driving pump catheter device according to claim 10, wherein, after setting the percentage of the volume of the inflated second balloon in relation to its volume of full inflation within the continuous range of numerical values, an adjustment of the percentage of the volume of the inflated second balloon in relation to its volume of full inflation is carried out in multiples of a certain interval step.

12. The intra-aortic dual balloon driving pump catheter device according to claim 11, wherein the interval step is 5% at least.

13. A method for operating an intra-aortic dual balloon driving pump catheter device having a first balloon and a second balloon surrounding a catheter and arranged successively along a longitudinal direction of the catheter, the method comprising: monitoring, by a monitoring part, a cardiac cycle and an arterial pressure at a distal end of the catheter; supplying and withdrawing, by air pumps through a first intake pipe and a second intake pipe, air to and from the first balloon and the second balloon; controlling the air pumps, by a controlling part, to inflate and deflate the first balloon and the second balloon according to the cardiac cycle and the arterial pressure at the distal end of the catheter; in diastole fully inflating the first balloon and fully deflating the second balloon; and in systole fully deflating the first balloon and inflating the second balloon only to a predetermined percentage of its volume of full inflation.

14. The method according to claim 13, further comprising: setting the intro-aortic dual balloon driving pump catheter device in an aorta; fully inflating the second balloon; and adjusting a percentage of a volume of the second balloon in relation to its volume of full inflation.

15. The method according to claim 14, further comprising adjusting the percentage of the volume of the second balloon in relation to its volume of full inflation based on a supportive effect on circulatory failure suggested by clinical feedback.

16. The method according to claim 15, further comprising setting the percentage of the volume of the inflated second balloon in relation to its volume of full inflation based on an arterial pressure monitored by the monitoring part and the supportive effect on circulatory failure suggested by clinical feedback.

17. The method according to claim 13, further comprising: selecting one of discrete numerical points preset in the controlling part; and setting the selected discrete numerical points as a value of the percentage of the volume of the second balloon in relation to its volume of full inflation.

18. The method according to claim 17, wherein interval steps between each adjacent pair of the discrete numerical points are identical.

19. The method according to claim 18, wherein the interval step is 5%.

20. The method according to claim 13, wherein a continuous range of numerical values are predetermined in the controlling part as a range of values to be taken when adjusting the percentage of the volume of the inflated second balloon in relation to its volume of full inflation.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0028] FIG. 1 shows a partial section view of an intra-aortic dual balloon driving pump catheter device according to a first embodiment of the present invention;

[0029] FIG. 2 shows a partial section view of an intra-aortic dual balloon driving pump catheter device according to a second embodiment of the present invention;

[0030] FIG. 3 shows a cross section view of an intra-aortic dual balloon driving pump catheter device according to the second embodiment of the present invention.

DETAILED DESCRIPTION

[0031] The intra-aortic dual balloon driving pump catheter device of the present invention will be described in detailed embodiments with reference to the accompanying drawings. It shall be noted that the accompanying drawings are given by way of illustration only, and shall not be construed as limiting the present invention.

[0032] The intra-aortic dual balloon driving pump catheter device is guided by a guide wire 1 of a catheter 2 and reaches a predetermined position within the aorta, and then the guide wire 1 exits from the catheter 2.

[0033] FIG. 1 shows a partial section view of an intra-aortic dual balloon driving pump catheter device according to the first embodiment of the present invention. As shown in the figure, a first balloon 4 and a second balloon 6 are arranged to successively surrounding the catheter 2 along the longitudinal direction of the catheter 2, wherein the position of the first balloon 4 is closer to a distal end of catheter 5 than the position of the second balloon 6. A first intake pipe 3 and a second intake pipe 7 have one end in communication with the first balloon 4 and the second balloon 6 respectively, and the other end in communication with the air pump (not shown) respectively associated with the balloons and used for supply and withdrawal of air.

[0034] FIG. 2 shows a partial section view of an intra-aortic dual balloon driving pump catheter device according to the second embodiment of the present invention. It differs from the first embodiment of the present invention in that, the first intake pipe 3 protruding from the first balloon 4 does not surround the catheter 2 which is through the first balloon 4 and the second balloon 6, but passes through the second balloon 6 individually. The first intake pipe 3 through the second balloon 6, the catheter 2, and the second intake pipe 7 protruding from the second balloon 6 extend in parallel with each other as shown in the figure.

[0035] The intra-aortic dual balloon driving pump catheter device of the present invention further comprises a monitoring part and a controlling part that are not shown in the figure. The monitoring part is used for monitoring the cardiac cycle and the arterial pressure of the catheter end 5, while the controlling part is adapted to control the air pumps to inflate and deflate the first balloon 4 and the second balloon 6 according to the cardiac cycle and the arterial pressure of the catheter end 5 monitored by the monitoring part, such that the first balloon 4 periodically inflates in diastole to occupy the space of blood in aorta, so as to push blood towards both sides of the first balloon, whereas deflates in systole to create space, so as to proactively extract pumped-out blood from the heart, and thus increases the cardiac output; and the second balloon inflates in systole to block the distal end of the aorta to prevent the blood flow at the distal end of the aorta from returning when the first balloon deflates, and deflates in diastole to make the blood flow created by the inflation of the first balloon be pushed forward downstream.

[0036] In this embodiment, the first intake pipe 3 protruding from the first balloon 4 surrounds and extends together with the catheter 2 through the second balloon 6, and then extends in parallel with the second intake pipe 7 protruding from the second balloon 6. An air pump associated with the first intake pipe 3 and the second intake pipe 7 respectively may supply, for example, helium gas into the first balloon 4 and the second balloon 6 to inflate the latter. The whole process of inflation is required to be completed within 130 ms. However, the air pumps are controlled such that the first balloon 4 inflates in diastole and deflates in systole, while the second balloon 6 inflates in systole and deflates in diastole. In diastole, the inflation of the first balloon 4 synchronizes with the deflation of the second balloon 6; in systole, the deflation of the first balloon 4 synchronizes with the inflation of the first balloon 6.

[0037] In diastole, the inflation of the first balloon 4 per se drives the blood to both the distal (cordis) and the proximal (peripheral) sides of the balloon in aorta, so that the diastolic pressure at the aortic root and coronary artery blood and myocardial oxygen supply are increased, and the blood is also simultaneously pushed forward downstream to supply the whole body. The second balloon deflates in diastole to make the blood flow created by the inflation of the first balloon be pushed forward downstream.

[0038] In systole, the negative pressure generated by the deflation of the first balloon 4 draws blood into the aortic cavity created by deflation, resulting in a decrease in the ejection resistance of the heart, or a decrease in the afterload of the heart, and an increase in the volume of blood expelled from the heart. The inflation of the second balloon 6 takes place at the same time when the first balloon 4 is deflating, thus the second balloon 6 forms a valve blocking the blood from being refluxed back into the cavity, such that the pumping effect caused by the deflation of the first balloon 4 does not affect the advancing blood downstream from the second balloon 6.

[0039] Herein, the air pumps are controlled such that the inflation and the deflation of the first balloon 4 synchronizes with the deflation and the inflation of the second balloon. That is, in diastole the first balloon 4 inflates while the second balloon 6 deflates, and in systole the first balloon 4 deflates while the second balloon 6 inflates, wherein the second balloon 6 deflates and inflates conversely to the synchronized inflation and deflation of the first balloon 4. Herein, the first balloon 4 fully inflates in diastole and fully deflates in systole, and the second balloon 6 fully deflates in diastole and can inflate in systole only to a predetermined percentage of its volume of full inflation. The predetermined percentage can be 100%, or 0%, or any intermediate value between 0% and 100%.

[0040] After the intra-aortic dual balloon driving pump catheter device is set in the aortic, the controlling part sets a percentage of the volume of the inflated second balloon 6 in relation to its volume of full inflation, which is based on an assessment of the supportive effect on circulatory failure suggested by clinical feedback. During the pumping process of the intra-aortic dual balloon driving pump catheter device within the aorta, the second balloon 6 always inflates to the same degree defined by this predetermined percentage. Thereafter, the controlling part can also adjust the percentage of the volume of the inflated second balloon 6 in relation to its volume of full inflation based on the supportive effect on circulatory failure suggested by clinical feedback. Typically, the percentage of the volume of the inflated second balloon 6 in relation to its volume of full inflation should be maintained at 100%, i.e. IADBP mode, by default, which can be adjusted based on the state of circulatory failure and the effect of circulatory support after the intra-aortic dual balloon driving pump catheter device has been placed (set in the aortic). Adjustments can be made easily and quickly by commands from the controlling part.

[0041] In particular, a number of discrete numerical points or a continuous range of numerical values are preset in the controlling part as the range of values to be taken for the percentage of the volume of the inflated second balloon in relation to its volume of full inflation, which makes it easy to qualitatively (i.e., to divide into different level options defined by the preset discrete value points) or quantitatively adjust the degree of inflation of the second balloon based on the state of circulatory failure and the effect of the circulatory support in the case of clinical use. For example, preset 0% or 25% or 50% or 75% or 100% as a set of possible ranges of values to be taken for the percentage of the volume of the inflated second balloon 6 in relation to its volume of full inflation, or preset 0% or 35% or 65% or 85% or 100% as a set of possible ranges of values to be taken. The interval steps between the discrete numerical points (level options) of the above first set of preset values are all evenly 25%. It should be understood that it is more advantageous to set the interval steps between these preset discrete numerical points (level options) to be equal, as it is clear that equal interval step settings facilitates easy and accurate clinical operation.

[0042] If a number of continuous ranges of numerical values is preset in the controlling part as the range of values to be taken for the percentage of the volume of the inflated second balloon in relation to its volume of full inflation, it would be possible to temporarily adjust the percentage of the volume of the inflated second balloon in relation to its volume of full inflation, by a preset interval step or its multiples, based on the state of circulatory failure and the effect of circulatory support. For example, first set it as 100% by default, and then select a certain volume percentage X % in a continuous range of numerical values from 100% to 30%, and if further adjustment is required, that volume percentage is adjusted in interval steps of 5% or multiples of 5%. This type of quantitative adjustment in predetermined interval steps helps the clinical user to quickly establish a feedback experience between the quantity of adjustment and the effect of the adjustment.

[0043] While the present invention has been described with reference to the preferred embodiments, the spirit and scope of the invention are not limited to the disclosure herein. According to the teaching of the present invention, those skilled in the art are able to deduce more embodiments and applications without departing from the spirit and scope of the present invention, which are not defined by the embodiments but by the appended claims.