Dual fiber optic pressure sensor assembly and percutaneous ventricular assist device

Abstract

The application relates to the technical field of medical devices, and discloses a double-fiber pressure sensor assembly and a percutaneous ventricular assist device. The double-fiber pressure sensor assembly comprises a shell, a first fiber pressure sensor and a second fiber pressure sensor. The shell has a first inner cavity and a second inner cavity, and opposite sides of the outer wall of the shell are respectively provided with a first window and a second window. The first window is in communication with the first inner cavity, and the second window is in communication with the second inner cavity. The end of the first fiber pressure sensor extends into the first inner cavity, and a first pressure sensing element is attached to the first window. The end of the second fiber pressure sensor extends into the second inner cavity, and a second pressure sensing element is attached to the second window. The shell is provided to encapsulate and protect the two fiber pressure sensors, which is conducive to the integrated installation of the two fiber pressure sensors and a catheter, so that the fiber pressure sensors can work in blood for a long time, and the two pressure sensing elements are prevented from interfering with each other, thereby improving the accuracy and stability of pressure detection.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a dual-fiber pressure sensor assembly and a transcutaneous ventricular assist device. Background Technology

[0002] A percutaneous ventricular assist device (pVAD) is a transcatheter intravascular miniature mechanical axial flow pump catheter used for short-term temporary ventricular support in patients with reduced ventricular function. It provides short-term mechanical support for blood circulation in patients with low output syndrome, acute myocardial infarction, persistent cardiogenic shock immediately following open-heart surgery, or myocarditis caused by cardiomyopathy or isolated ventricular failure. The pVAD uses an axial flow pump within the catheter to draw blood from the ventricles and pump it into the arteries, thereby compensating for insufficient left ventricular function and allowing adequate blood flow throughout the body.

[0003] The catheter has a blood inlet and an outlet; the inlet is placed in the ventricle, and the outlet is placed in the artery. If the catheter is mispositioned in the body, for example, if the inlet and outlet are both in the ventricle or aorta, it will increase the workload on the ventricle, affect blood flow, and have adverse effects on the patient. Therefore, it is crucial to keep the catheter in the correct working position throughout the entire operation of the percutaneous ventricular assist device, making catheter positioning extremely important.

[0004] In related technologies, integrating two fiber optic pressure sensors allows for real-time feedback of ventricular and arterial blood pressure information to the percutaneous ventricular assist device (PVC) control system. The pressure difference measured by the two sensors allows doctors to visually determine the correct catheter placement. However, due to the structural limitations of the PVC catheter, integrating the fiber optic pressure sensors with the catheter is difficult, and using two sensors further increases the packaging complexity. Additionally, during use, the fiber optic pressure sensors are susceptible to mechanical friction and tissue compression, affecting detection accuracy. Summary of the Invention

[0005] This invention provides a dual fiber optic pressure sensor assembly and a percutaneous ventricular assist device to solve the problems that the structural limitations of the percutaneous ventricular assist device catheter make it difficult to integrate the fiber optic pressure sensor with the catheter, and that using two fiber optic pressure sensors further increases the packaging difficulty. In addition, during use, the fiber optic pressure sensor is easily subjected to mechanical friction and tissue compression, which affects the detection accuracy.

[0006] In a first aspect, the present invention provides a dual-fiber pressure sensor assembly for use in a percutaneous ventricular assist device, the dual-fiber pressure sensor assembly comprising:

[0007] The housing has a first inner cavity and a second inner cavity that are parallel and separated. A first window and a second window are respectively provided on opposite sides of the outer wall of the housing. The first window communicates with the first inner cavity and the second window communicates with the second inner cavity. One of the first window and the second window is used to communicate with the inner lumen of the catheter of the percutaneous ventricular assist device, and the other is used to communicate with an artery.

[0008] The first fiber optic pressure sensor includes a first pressure-sensitive element disposed at its end, the end of the first fiber optic pressure sensor extending into the first inner cavity, and the first pressure-sensitive element fitting against the first window;

[0009] The second fiber optic pressure sensor includes a second pressure-sensitive element disposed at its end, the end of the second fiber optic pressure sensor extending into the second inner cavity, and the second pressure-sensitive element fitting against the second window.

[0010] As an optional implementation, the shell is shaped as a cuboid. The first inner cavity and the second inner cavity extend along the length direction of the shell and are parallel and spaced apart along the width direction. The first inner cavity and the second inner cavity penetrate the same side wall in the length direction of the shell and form an opening. The first window and the second window are respectively opened on opposite side walls in the height direction of the shell. The first window and the second window are staggered in the height direction.

[0011] As an optional implementation, a cross-section is made along the length of the shell, and the cross-sectional shape of the first inner cavity and the second inner cavity is circular or square.

[0012] As an optional implementation, the size of the first window is larger than the size of the second window.

[0013] As an optional implementation, the first fiber optic pressure sensor further includes a first fiber optic cable, the first pressure-sensitive element is disposed at the end of the first fiber optic cable, a portion of the first fiber optic cable is located in the first inner cavity, and the gap between the first fiber optic cable and the first inner cavity is filled with sealant; the second fiber optic pressure sensor further includes a second fiber optic cable, the second pressure-sensitive element is disposed at the end of the second fiber optic cable, a portion of the second fiber optic cable is located in the second inner cavity, and the gap between the second fiber optic cable and the second inner cavity is filled with sealant.

[0014] As an optional implementation, the outer wall of the housing is provided with a first vent hole communicating with the first inner cavity, the first vent hole and the first window are located on the same wall surface, and the first vent hole is located between the first window and the opening of the first inner cavity; the outer wall of the housing is provided with a second vent hole communicating with the second inner cavity, the second vent hole and the second window are located on the same wall surface, and the second vent hole is located between the second window and the opening of the second inner cavity.

[0015] As an optional implementation, the edges of the housing are provided with rounded chamfers.

[0016] In a second aspect, the present invention provides a percutaneous ventricular assist device, including the aforementioned dual fiber optic pressure sensor assembly.

[0017] In one optional embodiment, the percutaneous ventricular assist device further includes a catheter with a groove. The bottom wall of the groove has a third window communicating with the inner lumen of the catheter. The housing is embedded in the groove. The second window and the third window are correspondingly arranged, and the size of the third window is not smaller than the size of the second window.

[0018] In one alternative embodiment, a microgroove is formed on the outer wall of the conduit, the microgroove extending between the sink and the proximal end of the conduit, and the optical fiber is installed in the microgroove.

[0019] Beneficial effects:

[0020] 1. The dual-fiber pressure sensor assembly provided by this invention is applied to a percutaneous ventricular assist device. The dual-fiber pressure sensor assembly includes: a housing, a first fiber pressure sensor, and a second fiber pressure sensor. The housing has a first inner cavity and a second inner cavity arranged in parallel and separated manner. A first window and a second window are respectively provided on opposite sides of the outer wall of the housing. The first window communicates with the first inner cavity, and the second window communicates with the second inner cavity. One of the first window and the second window is used to communicate with the lumen of the catheter of the percutaneous ventricular assist device, and the other is used to communicate with an artery. The first fiber pressure sensor includes a first pressure-sensitive element disposed at its end, the end of which extends into the first inner cavity, and the first pressure-sensitive element is attached to the first window. The second fiber pressure sensor includes a second pressure-sensitive element disposed at its end, the end of which extends into the second inner cavity, and the second pressure-sensitive element is attached to the second window.

[0021] The first and second cavities of the housing respectively house a first fiber optic pressure sensor and a second fiber optic pressure sensor. The housing has a first window communicating with the first cavity and a second window communicating with the second cavity. Since one of the first and second windows communicates with the lumen of the percutaneous ventricular assist device catheter, and the other communicates with an artery, one of the first and second pressure-sensitive elements can measure blood pressure in the catheter lumen, and the other can measure arterial blood pressure. The blood pressure in the catheter lumen corresponds to the ventricular blood pressure, thus enabling the measurement of ventricular and arterial pressure information. In this structure, the blood flowing within the catheter does not directly impact the first or second window, preventing damage to either pressure-sensitive element. Furthermore, the housing design encapsulates and protects the two fiber optic pressure sensors, facilitating their integrated installation with the catheter and allowing them to operate continuously in the bloodstream. In addition, the first and second cavities of the housing are independent, preventing interference between the two pressure-sensitive elements and improving the accuracy and stability of pressure detection.

[0022] 2. The dual-fiber pressure sensor assembly provided by this invention has a rectangular shell. A first inner cavity and a second inner cavity extend along the length of the shell and are parallel and spaced apart along the width. The first and second inner cavities penetrate the same side wall along the length of the shell, forming an opening. A first window and a second window are respectively opened on opposite side walls along the height of the shell, and the first and second windows are staggered in the height direction. Designing the shell as a cuboid makes the overall shell flat, facilitating the smoothness of the outer wall of the catheter after installation on it, and also aiding in the fabrication of the first and second inner cavities. The openings of the first and second inner cavities are located on the same side of the shell, facilitating the installation of two fiber optic pressure sensors from the same side. The first and second windows face the inner and outer sides of the catheter, respectively, so that one window communicates with the catheter lumen, and the other communicates with the artery. After placing the two pressure-sensing elements close to the first and second windows, the staggered arrangement of the first and second windows further prevents mutual interference between the two pressure-sensing elements.

[0023] 3. The dual-fiber pressure sensor assembly provided by this invention has a cross-section along the length of the housing, with the first and second inner cavities having circular or square cross-sectional shapes. Designing the first and second inner cavities as circular or square shapes are readily available machining options, reducing machining difficulty and improving production efficiency. Furthermore, designing the cross-sectional shape as circular reduces frictional damage to the fiber pressure sensor and facilitates uniform filling of the sealant, while designing it as square provides stable radial positioning, ensuring the fitting accuracy between the pressure-sensing element and the window.

[0024] 4. In the dual-fiber pressure sensor assembly provided by this invention, the size of the first window is larger than the size of the second window. This arrangement facilitates the differentiation between the first and second windows by their different sizes, thereby distinguishing between the first and second fiber pressure sensors and making it easier to select the appropriate window to fit the conduit during installation.

[0025] 5. The dual-fiber pressure sensor assembly provided by this invention includes a first fiber optic pressure sensor further comprising a first fiber optic cable, a first pressure-sensitive element disposed at the end of the first fiber optic cable, a portion of the first fiber optic cable located within a first inner cavity, and a gap between the first fiber optic cable and the first inner cavity filled with sealant; and a second fiber optic pressure sensor further comprising a second fiber optic cable, a second pressure-sensitive element disposed at the end of the second fiber optic cable, a portion of the second fiber optic cable located within a second inner cavity, and a gap between the second fiber optic cable and the second inner cavity filled with sealant. On one hand, the sealant fills the gap, improving the sealing performance of the first and second inner cavities, effectively preventing blood from entering the first or second inner cavity and damaging the first or second pressure-sensitive element, thus ensuring stable operation of both pressure-sensitive elements in the blood environment over a long period. On the other hand, the sealant fixes the first and second fiber optic cables, preventing displacement of the first or second fiber optic cable that could lead to poor contact between the corresponding pressure-sensitive element and the corresponding window, thereby improving detection stability and accuracy.

[0026] 6. The dual-fiber pressure sensor assembly provided by the present invention has a first vent hole on the outer wall of the housing that communicates with the first inner cavity. The first vent hole and the first window are located on the same wall surface, and the first vent hole is located between the opening of the first window and the first inner cavity. The outer wall of the housing also has a second vent hole that communicates with the second inner cavity. The second vent hole and the second window are located on the same wall surface, and the second vent hole is located between the opening of the second window and the second inner cavity. The first and second vent holes serve two purposes: firstly, they act as vent holes, allowing air in the first and second inner cavities to be smoothly discharged during sealant injection; secondly, they serve as viewing holes, facilitating observation of the sealant injection process, so as to reasonably control the amount of sealant injected. This ensures that the sealant fully fills the gaps in the first and second inner cavities without contacting the pressure-sensing diaphragms on the two pressure-sensing elements, thus affecting the sensor's measurement accuracy.

[0027] 7. The dual-fiber pressure sensor assembly provided by this invention has rounded chamfers on the edges of its housing. This design prevents the housing from scratching human tissue and improves safety.

[0028] 8. The percutaneous ventricular assist device provided by the present invention also includes a catheter with a groove. A third window communicating with the inner lumen of the catheter is formed in the bottom wall of the groove. A housing is embedded in the groove. The second and third windows are correspondingly arranged, and the size of the third window is not smaller than the size of the second window. This arrangement allows the housing to be partially or completely embedded in the groove, ensuring the surface of the catheter is as flat as possible. The third window communicates with the second window, and a second pressure-sensitive element detects the blood pressure inside the catheter through the second and third windows, thereby detecting the blood pressure in the ventricles. The fact that the size of the third window is not smaller than the size of the second window prevents the second window from being obstructed, thus ensuring assembly accuracy and reducing blood flow fluctuations at the third window, further improving detection accuracy.

[0029] 9. The percutaneous ventricular assist device catheter provided by the present invention has microgrooves on its outer wall, which extend between the submerged groove and the proximal end of the catheter, and the optical fiber is installed in the microgroove. The microgroove facilitates the positioning of the first and second optical fibers, and also ensures that the surface of the catheter is as flat as possible. Attached Figure Description

[0030] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0031] Figure 1 This is a schematic diagram of the structure of the dual-fiber pressure sensor assembly according to an embodiment of the present invention;

[0032] Figure 2 This is a schematic diagram of the shell structure according to an embodiment of the present invention;

[0033] Figure 3 This is a partial cross-sectional view of the housing according to an embodiment of the present invention;

[0034] Figure 4 This is a cross-sectional structural diagram of the housing according to an embodiment of the present invention;

[0035] Figure 5 This is a schematic diagram of the percutaneous ventricular assist device according to an embodiment of the present invention;

[0036] Figure 6 This is a schematic diagram of the catheter and handle according to an embodiment of the present invention;

[0037] Figure 7 This is a schematic diagram illustrating the connection relationship between the shell and the conduit in an embodiment of the present invention;

[0038] Figure 8This is a schematic cross-sectional view of the settling tank according to an embodiment of the present invention;

[0039] Figure 9 This is a schematic diagram of the sedimentation tank and micro-channels according to an embodiment of the present invention;

[0040] Figure 10 This is a side view of the catheter according to an embodiment of the present invention;

[0041] Figure 11 This is a schematic cross-sectional view of the catheter according to an embodiment of the present invention.

[0042] Explanation of reference numerals in the attached figures:

[0043] 1. Housing; 11. First inner cavity; 111. First window; 112. First vent; 12. Second inner cavity; 121. Second window; 122. Second vent; 21. First fiber optic pressure sensor; 22. First fiber optic cable; 31. Second fiber optic pressure sensor; 32. Second fiber optic cable; 41. Conduit; 411. Settling tank; 4111. Third window; 412. Microgroove; 413. Fluid outlet; 414. Cover plate; 4141. Sealed space; 42. Access tube; 43. Handle; 431. Signal line; 44. Distal tube; 441. Fluid inlet; 45. Guide wire; 5. Control console. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] The following is combined with Figures 1 to 11 The following describes embodiments of the present invention.

[0046] like Figure 1 , Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, in one aspect, a dual fiber optic pressure sensor assembly is provided for use in a percutaneous ventricular assist device. The dual fiber optic pressure sensor assembly includes: a housing 1, a first fiber optic pressure sensor 21, and a second fiber optic pressure sensor 31.

[0047] The housing 1 has a first inner cavity 11 and a second inner cavity 12 arranged in parallel and separated manner. A first window 111 and a second window 121 are respectively provided on opposite sides of the outer wall of the housing 1. The first window 111 communicates with the first inner cavity 11, and the second window 121 communicates with the second inner cavity 12. One of the first window 111 and the second window 121 communicates with the inner cavity of the catheter 41 of the percutaneous ventricular assist device, and the other communicates with an artery. A first fiber optic pressure sensor 21 includes a first pressure-sensitive element disposed at its end, the end of which extends into the first inner cavity 11, and is fitted with the first window 111. A second fiber optic pressure sensor 31 includes a second pressure-sensitive element disposed at its end, the end of which extends into the second inner cavity 12, and is fitted with the second window 121.

[0048] Specifically, the housing 1 can be made of 316L stainless steel to ensure its structural strength and improve its protection of the first fiber optic pressure sensor 21 and the second fiber optic pressure sensor 31, preventing the detection accuracy of the first fiber optic pressure sensor 21 and the second fiber optic pressure sensor 31 from being affected by instrument friction and tissue compression. Since the catheter 41 of the percutaneous ventricular assist device is usually placed in an artery, with ventricular blood pressure and arterial blood pressure inside and outside the catheter 41 respectively, placing the first window 111 and the second window 121 on opposite sides of the housing 1 facilitates the correspondence between the first window 111 and the second window 121 and the blood inside and outside the catheter 41, respectively.

[0049] The first inner cavity 11 and the second inner cavity 12 of the housing 1 respectively house the first fiber optic pressure sensor 21 and the second fiber optic pressure sensor 31. The housing 1 has a first window 111 communicating with the first inner cavity 11 and a second window 121 communicating with the second inner cavity 12. Since one of the first window 111 and the second window 121 is used to communicate with the inner cavity of the catheter 41 of the percutaneous ventricular assist device, and the other is used to communicate with the artery, one of the first pressure-sensitive element and the second pressure-sensitive element can measure the blood pressure in the inner cavity of the catheter 41, and the other can measure the arterial blood pressure. The blood pressure in the inner cavity of the catheter 41 corresponds to the ventricular blood pressure, thereby realizing the measurement of ventricular and arterial pressure information. In this structure, the blood flowing in the catheter 41 will not directly impact the first window 111 or the second window 121, avoiding damage to the first pressure-sensitive element or the second pressure-sensitive element. Moreover, the housing 1 is designed to encapsulate and protect the two fiber optic pressure sensors, which is beneficial for integrating the two fiber optic pressure sensors with the catheter 41, allowing the fiber optic pressure sensors to work in the blood for a long time. In addition, the first inner cavity 11 and the second inner cavity 12 of the housing 1 are independent of each other, which can avoid mutual interference between the two pressure sensing elements and improve the accuracy and stability of pressure detection.

[0050] like Figure 1 , Figure 2and Figure 3 As shown, in one embodiment, the shell 1 is shaped as a cuboid. A first inner cavity 11 and a second inner cavity 12 extend along the length of the shell 1 and are parallel and spaced apart along the width direction. The first inner cavity 11 and the second inner cavity 12 penetrate the same side wall along the length of the shell 1, forming an opening. A first window 111 and a second window 121 are respectively opened on opposite side walls along the height direction of the shell 1. The first window 111 and the second window 121 are staggered in the height direction. Specifically, Figure 2 The solid arrows in the diagram indicate the length, width, and height directions corresponding to housing 1. Designing housing 1 as a cuboid makes it generally flat, facilitating the smoothing of the outer wall of catheter 41 after installation on it, and also aiding in the fabrication of the first inner cavity 11 and the second inner cavity 12. The openings of the first inner cavity 11 and the second inner cavity 12 are located on the same side of housing 1, allowing for the installation of two fiber optic pressure sensors from the same side. The first window 111 and the second window 121 face the inner and outer sides of catheter 41, respectively, so that one of the first window 111 and the second window 121 communicates with the inner cavity of catheter 41, and the other communicates with the artery. After placing the two pressure-sensitive elements close to the first window 111 and the second window 121, the staggered arrangement of the first window 111 and the second window 121 further prevents interference between the two pressure-sensitive elements.

[0051] like Figure 2 and Figure 4 As shown, in one embodiment, a cross-section is taken along the length of the housing 1, and the cross-sectional shape of the first inner cavity 11 and the second inner cavity 12 is circular or square. Designing the cross-section of the first inner cavity 11 and the second inner cavity 12 as circular or square are both readily available machining shapes, reducing the difficulty of machining the inner cavities and improving production efficiency. Furthermore, designing the cross-sectional shape as circular can reduce frictional damage to the fiber optic pressure sensor and facilitate uniform filling of the sealant, while designing the cross-sectional shape as square can provide stable radial positioning and ensure the fitting accuracy between the pressure-sensitive element and the window.

[0052] It should be noted that when filling with sealant, the pressure-sensitive diaphragms of the two pressure-sensitive elements must be exposed to ensure detection accuracy.

[0053] like Figure 3 As shown, in one embodiment, the size of the first window 111 is larger than the size of the second window 121. This arrangement facilitates the differentiation between the first window 111 and the second window 121 by their different sizes, thereby differentiating the first fiber optic pressure sensor 21 and the second fiber optic pressure sensor 31, so as to select the corresponding window to fit the conduit 41 during installation.

[0054] like Figure 1 and Figure 3As shown, in one embodiment, the first fiber optic pressure sensor 21 further includes a first fiber optic cable 22, with a first pressure-sensitive element disposed at the end of the first fiber optic cable 22. A portion of the first fiber optic cable 22 is located within the first inner cavity 11, and the gap between the first fiber optic cable 22 and the first inner cavity 11 is filled with sealant. The second fiber optic pressure sensor 31 further includes a second fiber optic cable 32, with a second pressure-sensitive element disposed at the end of the second fiber optic cable 32. A portion of the second fiber optic cable 32 is located within the second inner cavity 12, and the gap between the second fiber optic cable 32 and the second inner cavity 12 is filled with sealant. On one hand, the sealant fills the gap, improving the sealing performance of the first inner cavity 11 and the second inner cavity 12, effectively preventing blood from entering the first inner cavity 11 or the second inner cavity 12 and damaging the first or second pressure-sensitive element, thus ensuring stable operation of the two pressure-sensitive elements in the blood environment for a long time. On the other hand, the sealant can fix the first fiber optic cable 22 and the second fiber optic cable 32, preventing displacement of the first fiber optic cable 22 or the second fiber optic cable 32 that could lead to poor contact between the corresponding pressure-sensitive element and the corresponding window, thereby improving detection stability and accuracy.

[0055] like Figure 2 and Figure 3 As shown, the outer wall of the housing 1 is provided with a first vent 112 that communicates with the first inner cavity 11. The first vent 112 and the first window 111 are located on the same wall surface, and the first vent 112 is located between the opening of the first window 111 and the opening of the first inner cavity 11. The outer wall of the housing 1 is provided with a second vent 122 that communicates with the second inner cavity 12. The second vent 122 and the second window 121 are located on the same wall surface, and the second vent 122 is located between the opening of the second window 121 and the opening of the second inner cavity 12.

[0056] Specifically, during processing, the first pressure-sensitive element and the second pressure-sensitive element can be installed into the first inner cavity 11 and the second inner cavity 12 respectively using a microscope and a special fixture. After the first and second pressure-sensitive elements are installed in place, sealant can be filled through the openings on the same side of the first inner cavity 11 and the second inner cavity 12. The first vent hole 112 and the second vent hole 122 serve two purposes: firstly, they act as vent holes, allowing air in the first inner cavity 11 and the second inner cavity 12 to be smoothly discharged when the sealant is injected; secondly, they serve as viewing holes, facilitating observation of the sealant injection process, so as to reasonably control the amount of sealant injected, ensuring that the sealant fully fills the gaps in the first inner cavity 11 and the second inner cavity 12 without contacting the pressure-sensitive diaphragms on the two pressure-sensitive elements, thus affecting the sensor measurement accuracy.

[0057] like Figure 1 and Figure 2 As shown, the edges of the shell 1 are designed with rounded chamfers. This design prevents the shell 1 from scratching human tissue and improves safety.

[0058] like Figure 5 and Figure 9 As shown, according to an embodiment of the present invention, in another aspect, a percutaneous ventricular assist device is provided, including the aforementioned dual-fiber pressure sensor assembly, and further including a catheter 41, an access tube 42, a handle 43, a distal tube 44, and an axial flow pump. The distal tube 44 is connected to the distal end of the catheter 41 and is used for insertion into the ventricle. The distal end of the distal tube 44 is provided with a fluid inlet 441 for blood inflow. Correspondingly, a fluid outlet 413 is provided on the catheter 41. The axial flow pump is disposed inside the catheter 41 and is located between the fluid outlet 413 and the fluid inlet 441. Further, a housing 1 is installed on the outer wall of the catheter 41, and in the axial direction, the housing 1 is located between the axial flow pump and the fluid inlet 441. The distal end of the access tube 42 is connected to the proximal end of the catheter 41, and the proximal end of the access tube 42 is connected to the handle 43. The access tube 42 is used to accommodate a first optical fiber 22, a second optical fiber 32, and other wires. The handle 43 is used to control the axial flow pump and receive electrical signals from the first pressure-sensitive element and the second pressure-sensitive element. The handle 43 is connected to the console 5 via signal line 431.

[0059] In use, after the distal tube 44 and catheter 41 are placed in their corresponding positions, the fluid inlet 441 passes through the human valve and is located in the ventricle, while the fluid outlet 413 is located in the artery. The axial flow pump is started by controlling the handle 43. The impeller of the axial flow pump rotates and drives blood from the ventricle, fluid inlet 441, distal tube 44, catheter 41, and fluid outlet 413 into the artery, providing the power source for blood flow. During this process, one of the first and second pressure-sensitive elements is used to detect ventricular blood pressure, and the other is used to detect arterial blood pressure. The handle 43 transmits the electrical signals of ventricular blood pressure and arterial blood pressure to the control console 5 via signal line 431. The specific structure and function of the dual fiber optic pressure sensor assembly in this embodiment are exactly the same as those described above, and will not be repeated here.

[0060] like Figure 6 , Figure 7 and Figure 8 As shown, the conduit 41 is provided with a groove 411, and the bottom wall of the groove 411 is provided with a third window 4111 that communicates with the inner cavity of the conduit 41. The housing 1 is embedded in the groove 411. The second window 121 is provided in correspondence with the third window 4111, and the size of the third window 4111 is not less than the size of the second window 121.

[0061] Specifically, blood flows through the third window 4111 within the catheter 41. The blood then contacts the pressure-sensitive diaphragm of the second pressure-sensitive element through the third window 4111 and the second window 121, thereby detecting ventricular blood pressure. With this configuration, the housing 1 can be partially or completely embedded in the recess 411, ensuring the surface of the catheter 41 is as flat as possible. The third window 4111 communicates with the second window 121, and the second pressure-sensitive element detects the blood pressure within the catheter 41 through both the second window 121 and the third window 4111, thus detecting the ventricular blood pressure. The size of the third window 4111 is not smaller than the size of the second window 121 to prevent the second window 121 from being obstructed, thereby ensuring assembly accuracy and reducing blood flow fluctuations at the third window 4111, further improving detection accuracy.

[0062] In one embodiment, the conduit 41 is made of a metallic material, such as 316L stainless steel or a cobalt-chromium alloy.

[0063] In one embodiment, a sealing structure is provided between the housing 1 and the sink 411, the sealing structure being used to isolate the third window 4111 from the external environment of the conduit 41.

[0064] In one specific embodiment, the gap between the housing 1 and the recess 411 is welded using laser welding. For example, spot welding can be used to press the edge of the next weld point onto the center of the previous weld point, thereby ensuring a complete and seamless weld seam, achieving a sealing effect and preventing blood in the catheter 41 from communicating with the outside through the third window 4111, causing fluctuations in blood flow inside and outside the catheter 41 and affecting detection accuracy. Additionally, sealant can be applied to the weld seam to further enhance the sealing effect. Simultaneously, considering that the openings of the first inner cavity 11 and the second inner cavity 12 of the housing 1 extend from the first optical fiber 22 and the second optical fiber 32 respectively, and that the first optical fiber 22 and the second optical fiber 32 would obstruct the welding position between the lower housing 1 and the recess 411, the gap between the housing 1 and the recess 411 below the first optical fiber 22 and the second optical fiber 32 is sealed with sealant. The sealant can be applied to the weld seam, and then the area below the first optical fiber 22 and the second optical fiber 32 is evenly filled with sealant to form a larger sealing area, thereby enhancing the sealing effect. Of course, sealant can also be filled into the gap between the first optical fiber 22 and the second optical fiber 32 to further improve the sealing effect.

[0065] like Figure 10 and Figure 11As shown, in another embodiment, a cover plate 414 is provided on the outer side of the housing 1. The cover plate 414 has a U-shaped structure. The inner edge of the cover plate 414 is welded to the outer wall of the housing 1, and the first window 111 is exposed. The outer edge of the cover plate 414 is welded to the conduit 41. A sealed space 4141 is formed between the cover plate 414, the housing 1, and the conduit 41. The sealed space 4141 is filled with sealant. In this embodiment, the gap between the housing 1 and the sink 411 can be initially fixed by intermittent spot welding. The inner edge of the cover plate 414 is connected to the outer wall of the housing 1 by seamless welding. Similarly, the inner edge of the cover plate 414 is connected to the conduit 41 by seamless welding. Sealant is filled in the sealed space 4141 and applied to the gap between the housing 1 and the sink 411 outside the sealed space 4141. Thus, the gap between the housing 1 and the sink 411 is sealed by sealant, which can also prevent blood from entering the artery through the third window 4111. This arrangement is more conducive to ensuring the stability of the connection between the housing 1 and the conduit 41.

[0066] It should be noted that the sealing space covers most of the gap between the housing 1 and the recess 411, and includes the gap between the housing 1 and the recess 411 below the first optical fiber 22 and the second optical fiber 32, thereby further improving the sealing effect.

[0067] like Figure 9 As shown, in one embodiment, the outer wall of the percutaneous ventricular assist device catheter 41 provided by the present invention has a microgroove 412. The microgroove 412 extends between the groove 411 and the proximal end of the catheter 41, and the optical fiber is installed in the microgroove 412. The microgroove 412 facilitates the positioning of the first optical fiber 22 and the second optical fiber 32, while also ensuring that the surface of the catheter 41 is as flat as possible.

[0068] In one specific embodiment, the inner surface of the microgroove 412 is roughened by laser etching, and the first optical fiber 22 and the second optical fiber 32 can be fixed side by side in the microgroove 412 by sealant. The roughened microgroove 412 helps to increase the connection strength of the sealant.

[0069] In one specific implementation, the depth of the microgroove 412 ranges from 0.01 mm to 0.02 mm.

[0070] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A percutaneous ventricular assist device, characterized in that, include: The catheter (41) is provided with a groove (411), and the bottom wall of the groove (411) is provided with a third window (4111) communicating with the inner lumen of the catheter (41). The catheter (41) is used to insert an artery. The distal tube (44) is connected to the distal end of the catheter (41) and is used for insertion into the ventricle; The dual-fiber pressure sensor assembly includes: The housing (1) is embedded in the sink (411) and has a first inner cavity (11) and a second inner cavity (12) that are parallel and separated. The outer walls of the housing (1) are respectively provided with a first window (111) and a second window (121). The first window (111) communicates with the first inner cavity (11) and the second window (121) communicates with the second inner cavity (12). The second window (121) is correspondingly provided with the third window (4111) and communicates with the inner cavity of the catheter (41). The first window (111) is used to communicate with the artery. The first fiber optic pressure sensor (21) includes a first pressure-sensitive element disposed at its end. The end of the first fiber optic pressure sensor (21) extends into the first inner cavity (11), and the first pressure-sensitive element is attached to the first window (111). The second fiber optic pressure sensor (31) includes a second pressure-sensitive element disposed at its end. The end of the second fiber optic pressure sensor (31) extends into the second inner cavity (12), and the second pressure-sensitive element is attached to the second window (121).

2. The percutaneous ventricular assist device according to claim 1, characterized in that, The shell (1) is shaped as a cuboid. The first inner cavity (11) and the second inner cavity (12) extend along the length direction of the shell (1) and are parallel and spaced apart along the width direction. The first inner cavity (11) and the second inner cavity (12) penetrate the same side wall in the length direction of the shell (1) and form an opening. The first window (111) and the second window (121) are respectively opened on the opposite side walls in the height direction of the shell (1). The first window (111) and the second window (121) are staggered in the height direction.

3. The percutaneous ventricular assist device according to claim 2, characterized in that, A cross-section is taken along the length of the shell (1), and the cross-sectional shape of the first inner cavity (11) and the second inner cavity (12) is circular or square.

4. The percutaneous ventricular assist device according to claim 2, characterized in that, The size of the first window (111) is larger than the size of the second window (121).

5. The percutaneous ventricular assist device according to claim 2, characterized in that, The first fiber optic pressure sensor (21) further includes a first fiber optic cable (22), the first pressure-sensitive element is disposed at the end of the first fiber optic cable (22), a portion of the first fiber optic cable (22) is located in the first inner cavity (11), and the gap between the first fiber optic cable (22) and the first inner cavity (11) is filled with sealant; the second fiber optic pressure sensor (31) further includes a second fiber optic cable (32), the second pressure-sensitive element is disposed at the end of the second fiber optic cable (32), a portion of the second fiber optic cable (32) is located in the second inner cavity (12), and the gap between the second fiber optic cable (32) and the second inner cavity (12) is filled with sealant.

6. The percutaneous ventricular assist device according to claim 5, characterized in that, The outer wall of the housing (1) is provided with a first exhaust hole (112) communicating with the first inner cavity (11). The first exhaust hole (112) and the first window (111) are located on the same wall surface, and the first exhaust hole (112) is located between the opening of the first window (111) and the first inner cavity (11). The outer wall of the housing (1) is provided with a second exhaust hole (122) communicating with the second inner cavity (12). The second exhaust hole (122) and the second window (121) are located on the same wall surface, and the second exhaust hole (122) is located between the opening of the second window (121) and the second inner cavity (12).

7. The percutaneous ventricular assist device according to claim 2, characterized in that, The edges of the shell (1) are set with arc chamfers.

8. The percutaneous ventricular assist device according to claim 1, characterized in that, The size of the third window (4111) is not smaller than the size of the second window (121).

9. The percutaneous ventricular assist device according to claim 5, characterized in that, A microgroove (412) is provided on the outer wall of the conduit (41), the microgroove (412) extends between the sink (411) and the proximal end of the conduit (41), and the optical fiber of the dual optical fiber pressure sensor assembly is installed in the microgroove (412).

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