CN114504728A - A sensor for cardiac blood pump and cardiac blood pump - Google Patents

Abstract

The present invention provides a sensor for a cardiac blood pump and a cardiac blood pump. The sensor includes a static pressure sensing end arranged on a conveying sleeve of the cardiac blood pump, and the static pressure sensing end is used to detect the outside of the conveying sleeve. Static pressure flowing through blood; the static pressure sensing end includes a pressure sensing membrane chip and an optical signal transmission line, the pressure sensing membrane chip has a pressure sensing surface in contact with blood, and the pressure sensing surface is parallel to the delivery sleeve The pressure sensing membrane chip acquires a static pressure signal perpendicular to the direction of blood flow and transmits it through the optical signal transmission line. In the sensor provided by the present invention, the pressure sensing surface is parallel to the blood flow direction, and the static pressure of the blood is directly measured without setting a blood retention area at the static pressure sensing end to measure the static pressure of the blood, thereby avoiding the formation of thrombus and ensuring that the measurement can be performed even when the blood is flowing. Blood static pressure, which can be used for short and long-term intracardiac blood pump support.

Description

A sensor for cardiac blood pump and cardiac blood pump

technical field

The invention relates to the technical field of medical device design, in particular to a sensor for a cardiac blood pump and a cardiac blood pump.

Background technique

Heart failure refers to the failure of the systolic and/or diastolic function of the heart to fully discharge the venous blood back to the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system, resulting in cardiac circulatory disorder syndrome. Current treatments for heart failure include drug therapy, surgical replacement of the heart, and left ventricular assist devices. Among them, the left ventricular assist device is to pump blood through a heart blood pump to promote the flow of heart blood. This solution has the advantages of good treatment effect and low cost.

For the current intracardiac blood pump, in order to sense the intravascular pressure, a pressure sensor is usually used. The patent (US9669142) provides a pressure sensor, which is fixed on the blood pump catheter. In order to measure the static pressure of the blood that is not affected by the blood flow rate, the pressure sensor needs to add additional "wall" parts around the sensing surface of the sensor. Thereby, a blood retention area is created to measure the static pressure of blood; on the one hand, this solution has a complicated structure, and on the other hand, it is easy to form a thrombus in the blood retention area after a long time. In addition, the pressure sensing surface of the pressure sensor is orthogonal to the axis of the catheter, which requires a higher assembly process and is troublesome to assemble.

SUMMARY OF THE INVENTION

In view of the problems in the background art, the present invention provides a sensor for a cardiac blood pump, comprising a static pressure sensing end arranged on a delivery sleeve of the cardiac blood pump, and the static pressure sensing end is used to detect the delivery sleeve The static pressure of the blood flowing through the outside of the tube; the static pressure sensing end includes a pressure sensing membrane chip and an optical signal transmission line, the pressure sensing membrane chip has a pressure sensing surface in contact with the blood, and the pressure sensing surface is parallel to the conveying In the axial direction of the sleeve, the pressure sensing membrane chip acquires a static pressure signal perpendicular to the direction of blood flow and transmits it through the optical signal transmission line.

In some embodiments, both the pressure sensing film chip and the optical signal transmission line are arranged parallel to the axial direction of the delivery sleeve, and a vertical connection is arranged between the pressure sensing film chip and the optical signal transmission line. A path element that converts an optical signal into a horizontal optical signal.

In some embodiments, the path element adopts a right-angle reflective prism, and the right-angle reflective prism includes adjacent first and second right-angle surfaces, and an inclined surface connecting the first and second right-angle surfaces, The first right-angle surface is connected and arranged parallel to the pressure sensing film chip, the second right-angle surface is parallel to and connected to the distal end surface of the optical signal transmission line, and a reflective film is provided on the inclined surface.

In some embodiments, a self-focusing lens is disposed between the second right-angle surface and the optical signal transmission line.

In some embodiments, the pressure sensing membrane chip is vertically connected to the distal end of the optical signal transmission line, and the axial direction of the distal end of the optical signal transmission line is perpendicular to the axial direction of the delivery sleeve.

In some embodiments, a sheath is further included, and the optical signal transmission line is disposed in the sheath and extends along its axial direction; the pressure sensing membrane chip is disposed at the distal end of the sheath to constitute the At the static pressure sensing end, an opening for exposing the pressure sensing surface to be in contact with blood is provided at a corresponding position on the sheath.

In some embodiments, the pressure sensing membrane chip is placed in the opening, and the pressure sensing surface does not exceed the outer wall surface of the sleeve structure.

In some embodiments, the sheath is a sleeve structure, and the sleeve structure is disposed on the outer wall surface or the inner wall surface or in the tube wall of the delivery sleeve;

Alternatively, a channel is opened in the pipe wall of the delivery sleeve to form the sheath.

In some embodiments, the sleeve structure is provided on the outer wall surface of the delivery sleeve; the outer wall surface of the delivery sleeve is provided with a groove, and the sleeve structure is at least partially positioned in the groove Inside.

In some embodiments, the sleeve structure is bonded in the groove by a biocompatible glue.

In some embodiments, the material of the sleeve structure is polyimide.

In some embodiments, the diameter of the sleeve structure does not exceed 0.5 mm

In some embodiments, the end of the sleeve structure is arcuate.

In some embodiments, the optical signal transmission line employs optical fibers.

The present invention also provides a cardiac blood pump, at least one pressure sensor is provided on the delivery sleeve of the cardiac blood pump, and the pressure sensor adopts the above-mentioned sensor.

Compared with the prior art, the present invention has the following advantages and positive effects due to the adoption of the above technical solutions:

The pressure sensing surface of the sensor provided by the invention is parallel to the blood flow direction, and the static pressure of the blood is directly measured without setting a blood retention area at the static pressure sensing end to measure the static pressure of the blood, thereby avoiding the formation of thrombus and ensuring that the blood can also be measured when the blood is flowing. Static pressure, can be used for short and long-term intracardiac blood pump support; and does not require additional "enclosure" parts, the structure is simple, the diameter of the sensor system is smaller, and the damage to human tissue is less when implanted; in addition, the pressure sensing surface and The axial-parallel design of the delivery cannula directly measures the static pressure of blood, and does not require the pressure sensing surface to be orthogonal to the axis of the delivery cannula, which requires less assembly technology.

Description of drawings

The above and other features and advantages of the present invention will be more clearly understood from the following detailed description in conjunction with the accompanying drawings, wherein:

Fig. 1 is a schematic diagram of hydrostatic pressure;

2 is a schematic structural diagram of a sensor for a cardiac blood pump in Embodiment 1 of the present invention;

3 is a schematic cross-sectional view of a static pressure sensing end in Embodiment 1 of the present invention;

4 is a schematic structural diagram of a right-angle reflecting prism in Embodiment 1 of the present invention;

5 is a schematic structural diagram of a radial seal in the A-direction schematic diagram in FIG. 2;

6 is a schematic structural diagram of a sensor for a cardiac blood pump in Embodiment 2 of the present invention;

7 is a schematic cross-sectional view of a static pressure sensing end in Embodiment 2 of the present invention;

Fig. 8 is the enlarged schematic diagram at D in Fig. 6;

Fig. 9 is the schematic diagram of direction B in Fig. 6;

FIG. 10 is a schematic diagram of the direction C in FIG. 6 .

Detailed ways

The present invention will hereinafter be described in more detail with reference to the accompanying drawings, which illustrate embodiments of the invention. However, the present invention may be embodied in many different forms and should not be construed as limited by the embodiments set forth herein. Rather, these embodiments are presented so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity.

It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relationship between various components under a certain posture (as shown in the accompanying drawings). The relative positional relationship, the movement situation, etc., if the specific posture changes, the directional indication also changes accordingly.

The invention provides a sensor for a cardiac blood pump, comprising a static pressure sensing end arranged on a conveying sleeve of the cardiac blood pump, and the static pressure sensing end is used to detect the static pressure of the blood flowing through the outside of the conveying sleeve; The pressure sensing end includes a pressure sensing membrane chip and an optical signal transmission line. The pressure sensing membrane chip has a pressure sensing surface in contact with blood, the pressure sensing surface is parallel to the axial direction of the delivery sleeve, and the pressure sensing membrane chip captures the flow direction perpendicular to the blood flow. The static pressure signal is sent out through the optical signal transmission line.

The axial direction of the delivery sleeve of the cardiac blood pump is along the flow direction of the blood in the heart, and the sensor is sent into the heart together with the delivery sleeve to measure the static pressure of the blood in the heart. The static pressure can represent the blood flow of the heart. The working performance of the pump (flow rate, aortic pressure, left ventricular pressure, and pumping power) reflects whether the blood pump is in a normal working state, so as to facilitate subsequent operations such as data adjustment of the cardiac blood pump.

The sensor provided by the present invention can directly measure the static pressure of the blood by setting the pressure sensing surface in contact with the blood to be parallel to the axial direction of the delivery sleeve, that is, to make the pressure sensing surface parallel to the blood flow direction (wherein The explanation of static pressure is shown in Figure 1, the pressure perpendicular to the fluid flow direction is the hydrostatic pressure); the pressure sensing membrane chip transmits the acquired static pressure to the background controller through the optical signal transmission line, and the background controller is used for Process fiber optic signals and display them. The pressure sensing surface of the present invention is parallel to the blood flow direction, and the static blood pressure is directly measured without setting a blood retention area at the static pressure sensing end to measure the blood static pressure, thereby avoiding the formation of thrombus and ensuring that the blood static pressure can also be measured when the blood is flowing. It can be used for short and long-term intracardiac blood pump support; and does not require additional "enclosure" parts, the structure is simple, the diameter of the sensor system is smaller, and the damage to human tissue is less when implanted; in addition, the pressure sensing surface and delivery cannulae The axial-parallel design of the device can directly measure the static pressure of blood, and it does not need the pressure sensing surface to be orthogonal to the axis of the delivery sleeve, which requires less assembly process.

The specific embodiments are further described below:

Example 1

2-5, in this embodiment, the sensor 1 includes a pressure sensing membrane chip 101 and an optical signal transmission line 102. The pressure sensing membrane chip 101 and the optical signal transmission line 102 are both arranged parallel to the axial direction of the conveying sleeve 3; the optical signal transmission line 102 The proximal end is connected to the background controller 2, and the distal end is connected to the pressure sensing membrane chip 101 through a path element, and the path element 103 is used to convert the vertical optical signal (the optical signal in the direction perpendicular to the pressure sensing membrane chip 101) into a horizontal optical signal (optical signal in the direction parallel to the optical signal transmission line 102).

In this embodiment, the optical signal transmission line 102 is preferably an optical fiber. Of course, other optical signal transmission lines with the same function may also be used in other embodiments, which is not limited here.

In this embodiment, the pressure sensing membrane chip is composed of a pressure sensing membrane and a chip, the pressure sensing membrane and the chip are arranged in parallel, and there is a gap between them so that a standard cavity length is formed between them, and the pressure sensing membrane is in contact with blood When the pressure is sensed, the chip is connected with the optical signal transmission line to realize the transmission of the optical signal; after the pressure sensing film is subjected to static pressure, the pressure sensing film is concavely deformed to one side of the chip, and the distance between the pressure sensing film and the chip is shortened, that is, the cavity length occurs. Therefore, the formation of light transmission changes, and the background controller can obtain the formation and stroke of light transmission before and after the static pressure.

In this embodiment, the pressure sensing membrane adopts a biocompatible ceramic membrane or glass membrane, etc., which is not limited here, and can be adjusted according to specific conditions.

In this embodiment, the path element adopts a right-angle reflecting prism 103; specifically, referring to FIGS. 3-4 , the right-angle reflecting prism 103 includes adjacent first right-angle surfaces 1031 and second right-angle surfaces 1032, and connects the first right-angle surfaces 1031 and the inclined surface 1033 of the second right-angled surface 1032; the first right-angled surface 1031 is arranged opposite to the pressure sensing membrane chip 101, and the first right-angled surface 1031 is connected to the pressure sensing membrane chip 101; the second right-angled surface 1032 is parallel to the optical signal transmission line 102 The end faces of the far end are oppositely arranged, and the second right angle surface 1032 is connected to the far end of the optical signal transmission line 102; the inclined surface 1033 is provided with a reflective film, through the setting of the right angle reflective prism 103, the optical signal is bent by 90° under the action of the reflective film The optical signal transmission between the optical signal transmission lines 102 arranged in parallel and the pressure sensing membrane chip 101 is realized.

Of course, the specific structures of the path elements in other embodiments are not limited to the above, and prisms or optical elements of other structures can also be selected, as long as the optical signal transmission direction can be changed, which is not limited here, and can be determined according to specific circumstances. to make a selection.

Further, a self-focusing lens is added between the second right-angle surface 1032 and the optical signal transmission line 102 to increase the sensitivity of the optical signal, thereby helping to reduce measurement errors; of course, in other embodiments, the setting of the self-focusing lens can also be omitted. There are no restrictions here.

In this embodiment, the sensor 1 further includes a sheath, and the pressure sensing membrane chip 101, the path element and the optical signal transmission line 102 are all arranged in the sheath to play a protective role; wherein, the optical signal transmission line 102 is along the axial direction of the sheath. The extended arrangement, the pressure sensing membrane chip 101 is located at the distal end of the sheath 4, so that the distal end of the sheath 4 constitutes a static pressure sensing end. openings that come into contact with blood.

In this embodiment, the sheath is a sleeve structure 4, the sleeve structure 4 is arranged on the outer wall of the conveying sleeve 3 along the axial direction of the conveying sleeve 3, the proximal end extends to the background controller 2, and the distal end extends to the background controller 2. to the static pressure sensing end; of course, in other embodiments, the sleeve structure 4 can also be disposed on or in the inner wall of the delivery sleeve 3 , which is not limited here.

Further, an opening is provided on the distal side wall of the sleeve structure 4, the pressure sensing membrane chip 101 is placed in the opening, and it is ensured that the pressure sensing surface of the pressure sensing membrane chip 101 does not exceed the outer wall surface of the sleeve structure 4, thereby preventing When the cannula structure 4 is implanted into the heart with the delivery cannula 3 , the pressure sensing membrane chip 101 scrapes the cardiac tissue; further preferably, the pressure sensing surface of the pressure sensing membrane chip 101 is flush with the outer wall surface of the cannula structure 4 , not only to avoid scratching the tissue, but also to avoid blood retention to form a thrombus.

Further, a groove 301 is provided on the outer wall surface of the delivery sleeve 3, at least the distal end of the sleeve structure 4 is positioned in the groove 301, and the sleeve structure 4 is bonded in the groove 301 by biocompatible glue to achieve fixation. , as shown in Figure 5. In this embodiment, the arrangement of the groove 301 ensures that the axial direction of the distal end of the sleeve structure is parallel to the axial direction of the delivery sleeve 3, thereby ensuring that the static pressure sensing surface can be accurately parallel to the blood flow direction, thereby ensuring accurate detection. Among them, the casing structure 4 can be positioned entirely or partially through the groove 301, as long as the distal end of the casing structure 4 (ie, the static pressure sensing end) is located in the groove 302 to achieve precise positioning, which is not done here. Limits can be adjusted on a case-by-case basis. Of course, in other embodiments, the positioning structure of the sleeve structure 4 is not limited to the groove structure described above, and can be adjusted according to specific conditions, which is not limited here.

Further, the material of the sleeve structure 4 is preferably polyimide. Of course, in other embodiments, the sleeve structure can also be made of other materials, as long as the biocompatibility, mechanical strength, and processing performance are guaranteed, which is not done here. limit.

Further, the diameter of the cannula structure 4 does not exceed 0.5mm, which can reduce and increase the size of the entire delivery cannula while ensuring that the sensor can be packaged, so as to facilitate the implantation of the delivery cannula; the specific value of the diameter of the cannula structure 4 is It can be adjusted according to the specific situation, and there is no limitation here.

Further, as shown in FIG. 3 , the distal end of the sleeve structure 4 is in a smooth arc shape, so that the sleeve structure 4 can be smoothly implanted into the heart along with the delivery sleeve 3 .

The sheath provided in this embodiment has a simple structure and is easy to install. Of course, in other embodiments, the implementation of the sheath is not limited to the above. For example, a channel is opened in the pipe wall of the delivery sleeve 3 to form the sheath. There are no restrictions.

The working principle of the sensor provided in this embodiment is further described below:

After the sensor is implanted into the heart with the delivery cannula, the blood flows through the outside of the delivery cannula parallel to the axial direction of the delivery cannula. At this time, the pressure sensing membrane chip 101 parallel to the blood flow direction can detect the static pressure of the blood. Then it is transmitted to the background controller through the optical signal transmission line 102 .

Example 2

This embodiment is adjusted on the basis of Embodiment 1.

Specifically, referring to FIGS. 6-10 , in this embodiment, the sensor includes a sleeve structure 4 , and an optical signal transmission line 102 and a pressure sensing film chip 101 are arranged in the sleeve structure 4 , and the optical signal transmission line 102 runs along the sleeve structure 4 . The end face of the distal end of the optical signal transmission line 102 has an opening, the pressure sensing membrane chip 101 is installed in the opening, and the pressure sensing membrane chip 101 is perpendicular to the axial direction of the optical signal transmission line 102 and is connected to it.

In this embodiment, the arrangement of the path element is omitted, so that the pressure sensing film chip 101 is vertically connected with the optical signal transmission line 102 to directly realize the transmission of the optical signal.

In this embodiment, the cannula structure 4 is fixed on the delivery cannula 3 by winding, and the distal end of the cannula structure 4 is bent in a 90° arc shape, so that the end face of the distal end of the cannula structure 4 is parallel to the The axial direction of the delivery cannula 3 is such that the pressure sensing membrane chip 101 on the distal end surface of the cannula structure 4 is parallel to the flow direction of the blood, so as to ensure the measurement of the static pressure of the blood. As shown in Figure 7-8.

Further, a groove is also provided on the outer wall surface of the delivery sleeve 3, so that the sleeve structure is fixed in the groove to realize positioning and installation; the distal end of the sleeve structure 4 is not provided with a groove structure, and the sleeve structure 4 is far away The end is directly fixed on the outer wall surface of the delivery cannula 3 through biocompatible glue, and the glue on the side facing away from the blood flow direction is streamlined, as shown in Figure 10. A blood retention area is formed on the side of the blood flow, thereby preventing the formation of blood clots.

Other structures of the sensor in this embodiment can be referred to as described in Embodiment 1.

Example 3

This embodiment provides a cardiac blood pump, at least one pressure sensor is provided on the delivery sleeve of the cardiac blood pump, and the pressure sensor adopts the sensor described in Embodiment 1 or Embodiment 2.

The cardiac blood pump is suitable for both right ventricular assist devices and left ventricular assist devices; the left ventricle assists in detecting aortic root blood pressure, corresponding to the right ventricle assisting in detecting right atrial blood pressure; Pulmonary arterial blood pressure.

Taking left ventricular assist as an example, at least one pressure sensor, preferably one pressure sensor, is set on the cardiac blood pump, and the static pressure sensing end of the pressure sensor is fixed on the outer surface of the proximal cannula of the cardiac blood pump to detect the blood pressure at the aortic root. ; Two pressure sensors can also be provided on the cardiac blood pump, and the static pressure sensing end of the second pressure sensor is fixed on the outer surface of the distal sleeve of the intracardiac blood pump to detect left ventricular blood pressure.

The setting position and setting quantity of the pressure sensor on the cardiac blood pump can be selected according to the specific situation, and there is no limitation here.

The invention takes the left ventricle assist as an example to illustrate, and can also be used for right ventricular assist, the left ventricle assists in detecting the blood pressure at the aortic root, and corresponds to the right ventricle to assist in detecting the right atrial blood pressure; blood pressure.

It should be understood by those skilled in the art that the present invention may be embodied in many other specific forms without departing from its own spirit or scope. Although embodiments of the present invention have been described, it should be understood that the present invention should not be limited to these embodiments, but changes and modifications may be made by those skilled in the art within the spirit and scope of the present invention as defined by the appended claims.

Claims (15)

1. A sensor for a heart blood pump is characterized by comprising a static pressure sensing end arranged on a conveying sleeve of the heart blood pump, wherein the static pressure sensing end is used for detecting the static pressure of blood flowing through the outer side of the conveying sleeve; the static pressure sensing end comprises a pressure sensing membrane chip and an optical signal transmission line, the pressure sensing membrane chip is provided with a pressure sensing surface which is in contact with blood, the pressure sensing surface is parallel to the axial direction of the conveying sleeve, and the pressure sensing membrane chip acquires a static pressure signal which is perpendicular to the flowing direction of blood flow and transmits the static pressure signal out through the optical signal transmission line.

2. The sensor for a heart blood pump of claim 1, wherein the pressure sensing membrane chip and the optical signal transmission line are both disposed parallel to the axial direction of the delivery cannula, and a path element for converting a vertical optical signal into a horizontal optical signal is disposed between the pressure sensing membrane chip and the optical signal transmission line.

3. The sensor for the heart blood pump as claimed in claim 2, wherein the path element is a right-angle reflecting prism, the right-angle reflecting prism comprises a first right-angle surface and a second right-angle surface which are adjacent to each other, and an inclined surface connecting the first right-angle surface and the second right-angle surface, the first right-angle surface is arranged in parallel with the pressure sensing film chip, the second right-angle surface is arranged in parallel with the distal end face of the optical signal transmission line and is connected with the optical signal transmission line, and a reflecting film is arranged on the inclined surface.

4. The sensor for the heart blood pump of claim 3, wherein a self-focusing lens is arranged between the second right-angle surface and the optical signal transmission line.

5. The sensor for a heart blood pump of claim 2, wherein the pressure sensing membrane chip is vertically connected to a distal end of the optical signal transmission line, and an axial direction of the distal end of the optical signal transmission line is perpendicular to an axial direction of the delivery sleeve.

6. The sensor for a heart blood pump according to claim 1, 2 or 4, further comprising a sheath, wherein the optical signal transmission line is disposed in the sheath and extends axially along the sheath; the pressure sensing membrane chip is arranged at the far end of the sheath to form the static pressure sensing end, and an opening for exposing the pressure sensing surface to be contacted with blood is arranged at the corresponding position on the sheath.

7. The sensor for a heart blood pump of claim 6, wherein said pressure sensing diaphragm chip is disposed within said opening and said pressure sensing surface does not extend beyond an outer wall surface of said sleeve structure.

8. The sensor for a heart blood pump of claim 6, wherein the sheath is a sleeve structure disposed on an outer wall surface or on an inner wall surface or within a tube wall of the delivery sleeve;

or, a channel is arranged in the pipe wall of the conveying sleeve to form the sheath.

9. The sensor for a heart blood pump of claim 8, wherein said sleeve structure is disposed on an outer wall surface of said delivery sleeve; the outer wall surface of the conveying sleeve is provided with a groove, and the sleeve structure is at least partially positioned in the groove.

10. The sensor for a heart blood pump of claim 9, wherein said sleeve structure is bonded within said recess by a biocompatible glue.

11. The sensor for a heart blood pump of claim 8, wherein the material of the sleeve structure is polyimide.

12. A sensor for a heart blood pump according to claim 8, wherein the diameter of the sleeve structure is no more than 0.5 mm.

13. The sensor for a cardiac blood pump according to claim 8, wherein the distal end of the sleeve structure is radiused.

14. The sensor for a heart blood pump of claim 1, wherein said optical signal transmission line is an optical fiber.

15. A heart blood pump, characterized in that at least one pressure sensor is arranged on a delivery sleeve of the heart blood pump, and the pressure sensor adopts a sensor as claimed in any one of claims 1 to 14.

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