阅读说明：本技术 一种球囊式心脏瓣膜在体测量装置 (Balloon type heart valve in-vivo measuring device ) 是由 王盛章 黎健明 蔡云寒 冯勇 于 2021-01-07 设计创作，主要内容包括：本发明属于医疗器械技术领域,具体涉及一种球囊式心脏瓣膜在体测量装置。所述球囊式心脏瓣膜在体测量装置包括体内测量组件和体外压力控制组件；所述体内测量组件包括测量球囊、球囊导管、设置于测量球囊两端的显影点和设置于测量球囊外壁的金属条；所述体外压力控制组件包括压力控制装置和压力测量仪；所述压力控制装置上设置有瓣膜尺寸标尺,所受压力测量仪上设置有压力读数表盘；所述球囊导管一端连接测量球囊,另一端连接压力测量仪。本发明的球囊式心脏瓣膜在体测量装置用于经导管瓣膜置换术,属于介入式的心脏瓣膜测量装置,不产生额外的手术创口,且测量结果准确。(The invention belongs to the technical field of medical instruments, and particularly relates to an in-vivo measuring device for a balloon type heart valve. The balloon type heart valve in-vivo measuring device comprises an in-vivo measuring assembly and an in-vitro pressure control assembly; the in-vivo measuring component comprises a measuring saccule, a saccule catheter, developing points arranged at two ends of the measuring saccule and metal strips arranged on the outer wall of the measuring saccule; the extracorporeal pressure control assembly comprises a pressure control device and a pressure measuring instrument; the pressure control device is provided with a valve size scale, and the pressure measuring instrument is provided with a pressure reading dial; one end of the balloon catheter is connected with the measuring balloon, and the other end of the balloon catheter is connected with the pressure measuring instrument. The balloon type heart valve in-vivo measuring device is used for transcatheter valve replacement, belongs to an interventional type heart valve measuring device, does not generate additional operation wounds, and has accurate measuring results.)

1. A balloon type heart valve in-vivo measuring device is characterized by comprising an in-vivo measuring component and an in-vitro pressure control component;

the in-vivo measuring component comprises a measuring saccule, a saccule catheter, developing points arranged at two ends of the measuring saccule and metal strips arranged on the outer wall of the measuring saccule;

the extracorporeal pressure control assembly comprises a pressure control device and a pressure measuring instrument; the pressure control device is provided with a valve size scale, and the pressure measuring instrument is provided with a pressure reading dial;

one end of the balloon catheter is connected with the measuring balloon, and the other end of the balloon catheter is connected with the pressure measuring instrument.

2. The balloon-type heart valve in-vivo measurement device according to claim 1, wherein the metal strips are uniformly distributed along the circumferential direction of the outer wall of the measurement balloon in an arrangement parallel to the axial direction of the measurement balloon.

3. The balloon heart valve in-vivo measurement device according to claim 2, wherein the number of the metal strips is 3-12.

4. The balloon-type heart valve in-vivo measurement device according to claim 2, wherein the metal strip is made of nitinol.

5. The balloon heart valve in-vivo measurement device according to claim 1, wherein the visualization point has a visualization segment length of 1-5 mm.

6. The balloon type heart valve in-vivo measurement device as claimed in claim 1, wherein the material of the visualization point is platinum.

7. The balloon-type heart valve in-vivo measurement device according to claim 1, wherein the measurement balloon is a non-compliant folded balloon.

8. The balloon-type heart valve in-vivo measurement device according to claim 1, wherein the measurement balloon is initially in a folded state; preferably, the measuring balloon is initially in a 3-6 fold configuration.

9. The balloon heart valve in-vivo measurement device of claim 8, wherein the initial diameter of the measurement balloon is 4-8 mm.

10. Use of a balloon heart valve in-vivo measurement device according to claims 1-9 in the field of medical device technology.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an in-vivo measuring device for a balloon type heart valve.

Technical Field

Heart valves exist between the atria and ventricles and between the ventricles and the arteries, ensuring unidirectional flow of blood. When a valve is diseased, stenosis or insufficiency often occurs, which leads to a series of heart diseases. Transcatheter valve replacement is a minimally invasive valve treatment procedure in which a prosthetic valve is delivered by a catheter to the site of a diseased valve via an artery or vein or apex of the heart to replace the original diseased valve. Prior to performing transcatheter valve replacement, the valve measurement device is used to measure the size of the patient's valve to determine the appropriate size of the implanted valve. Most of the existing valve measuring devices are mechanical devices, the structures are complex, the existing valve measuring devices are matched with a 3d printed blood vessel model before an operation to perform in-vitro measurement, the in-vivo state of a valve cannot be truly reflected, the measuring process is complicated, and the error of the measuring result is large. Therefore, it is necessary to design an intraoperative valve in vivo measurement device.

Disclosure of Invention

The invention relates to a balloon type heart valve in-vivo measuring device for interventional valve operation, which is used for measuring the size of a valve in vivo before the valve is implanted in the operation, does not need secondary operation or additional trauma, can greatly improve the accuracy of valve measurement and determine the proper size of the implanted valve.

The invention discloses a balloon type measuring device for measuring valve size, which comprises a measuring balloon with a developing point, a metal strip coated on the outer wall of the balloon, a balloon catheter and a pressure control system. And expanding the balloon through a pressure control system to complete valve measurement, and reading the size of the implanted valve from a valve size scale on the pressure control device.

Specifically, the technical scheme of the invention is as follows:

the invention discloses a balloon type heart valve in-vivo measuring device in a first aspect, which comprises an in-vivo measuring component and an in-vitro pressure control component;

the in-vivo measuring component comprises a measuring saccule, a saccule catheter, developing points arranged at two ends of the measuring saccule and metal strips arranged on the outer wall of the measuring saccule;

the extracorporeal pressure control assembly comprises a pressure control device and a pressure measuring instrument; the pressure control device is provided with a valve size scale, and the pressure measuring instrument is provided with a pressure reading dial;

one end of the balloon catheter is connected with the measuring balloon, and the other end of the balloon catheter is connected with the pressure measuring instrument.

Preferably, the metal strips surround the middle of the balloon, the metal strips are uniformly distributed along the circumferential direction of the outer wall of the measuring balloon, and the arrangement mode of the metal strips is parallel to the axial direction of the measuring balloon.

The metal strip provides supporting force for the even expansion of measuring sacculus along axial, makes measuring sacculus middle part and both ends expand in step.

Preferably, the number of the metal strips is 3-12.

Preferably, the metal strip is made of nickel titanium alloy.

Preferably, the developing section length of the developing point is 1-5 mm. Developing points are arranged at two ends of the measuring saccule for capturing and observing dynamic CT images.

Preferably, the developing point is made of platinum.

Preferably, the measurement balloon is a non-compliant folded balloon.

Preferably, the measurement balloon is initially in a folded state; more preferably, the measuring balloon is initially in a 3-6 fold configuration.

More preferably, the initial diameter of the measurement balloon is 4-8 mm.

One end of the sacculus conduit is connected with the measuring sacculus, and the other end is connected with the pressure measuring instrument. The pressure measuring instrument is connected with the control system and controls the pressure in the measuring device to increase or decrease.

Alternatively, when the balloon-type valve size measuring device is used, the measuring balloon and the balloon catheter are delivered into the body in an interventional manner, and an external pressure control assembly comprising a pressure control device and a pressure measuring instrument is used for controlling and measuring the internal pressure of the balloon in vitro. The pressure control device is marked with a valve size scale, and the corresponding size of the implanted valve can be read out by finally measuring the pressure value of the balloon.

The invention discloses an application of the balloon type heart valve in the technical field of medical instruments in a body measurement device in a second aspect.

Compared with the prior art, the invention has at least the following beneficial effects:

1. the balloon type heart valve in-vivo measuring device is used for transcatheter valve replacement, belongs to an interventional type heart valve measuring device, does not generate extra operation wounds, and has accurate measuring results.

2. The middle part of the measuring balloon is coated with the metal strips which are axially arranged, so that the synchronous expansion of the middle part of the balloon and the two ends of the balloon can be maintained, and the measuring accuracy is improved.

3. The two ends of the measuring saccule are provided with the developing points, so that the measuring saccule can be monitored under a dynamic CT image.

4. The measuring balloon adopts a folding structure, reduces the initial volume of the balloon and is convenient to use in interventional operations.

Drawings

Fig. 1 is a schematic structural diagram of a balloon-type heart valve in-vivo measurement device in the invention.

Fig. 2 is a schematic illustration of the delivery of the measurement balloon to the working position.

Fig. 3 is a schematic illustration of measuring valve size after balloon expansion.

Fig. 4 is a schematic cross-sectional view of a measurement balloon before valve sizing (before dilation).

Fig. 5 is a schematic view of the measurement balloon after valve sizing (post dilation).

Fig. 6 is a schematic cross-sectional view of the measurement balloon after valve sizing (post dilation).

Description of reference numerals:

1-measuring the balloon; 11-development point; 12-a metal strip; 2-a balloon catheter; 3-a pressure control device; 31-valve size scale; 4-a pressure gauge; 41-pressure reading dial plate; 5-vessel wall or ventricular wall structure at the valve.

Detailed Description

The present application is further illustrated by the following detailed examples, which should be construed to be merely illustrative and not limitative of the remainder of the disclosure.

Example 1

The balloon-type heart valve in-vivo measurement device of the present embodiment, as shown in fig. 1, includes an in-vivo measurement component 1, 11, 12, 2 and an in-vitro pressure control component 3, 31, 4, 41.

The invention is used for transcatheter heart valve replacement operation, the balloon type heart valve measuring device is firstly used in the operation, the measuring balloon 1 is conveyed to the position of a replacement valve to complete valve measurement, and then after the measuring balloon is withdrawn, the subsequent valve implantation is completed along the original path. The procedure for completing the valve measurement in vivo does not create additional trauma.

The measuring balloon 1 is a non-compliant folded balloon, and the inside of the measuring balloon is connected with a balloon catheter 2. The two ends of the measuring saccule 1 are provided with developing points 11, and the developing points can be tracked through dynamic CT images in the valve measuring process to monitor the measuring saccule 1 in real time. According to the use requirement, as shown in fig. 2, the measuring balloon 1 is conveyed to the position of a diseased heart valve, the position of the measuring balloon 1 is adjusted to enable the valve ring to be positioned at the middle point of the connecting line of the developing points 11 at the two ends of the measuring balloon, and the positioning of the measuring balloon 1 is completed. The measuring balloon 1 is initially in a folded state, has a smaller diameter, and the diameter is continuously enlarged during measurement until the outer wall of the measuring balloon 1 is completely contacted with the valve annulus, as shown in fig. 3. A schematic cross-sectional view of the measurement balloon before valve sizing (before dilation) is shown in fig. 4. A schematic of the measurement balloon after valve sizing (post dilation) is shown in fig. 5. A schematic cross-sectional view of the measurement balloon after valve sizing (post dilation) is shown in fig. 6.

Measure 1 outer wall of sacculus and adhere to there is metal strip 12, and in sacculus expansion process, outer wall metal strip 12 does not take place to warp, plays along the axial tractive effect of sacculus to measuring 1 outer wall of sacculus for measure 1 in the expansion in-process keep the cylinder shape of uniform cross-section, avoid appearing in the expansion process that both ends are thick, the thin "dog bone" shape in centre causes to measure 1 adherence of sacculus not good, arouses measuring error.

One end of the balloon catheter 2 is connected with the measuring balloon 1, and the other end is connected with the pressure control device 3 through the pressure measuring instrument 4. The pressure control device 3 can be used for injecting or pumping liquid into the balloon catheter 2, so that the pressure in the measuring balloon 1 is increased or reduced, and the expansion and contraction of the balloon are controlled. The pressure measuring instrument 4 measures the pressure in the balloon catheter 1, and displays the current pressure value through the pressure reading dial.

A valve size scale 31 is attached to the pressure control device 3, and displays the measurement result of the current valve size, which indicates the size of the implanted valve corresponding to the current expansion state of the measurement balloon 1. After the pressure control device 3 is pressurized, the size measurement of the valve can be read from the valve size scale 31 to determine the size of the implanted valve.

When the balloon type heart valve in-vivo measuring device is used, the measuring balloon 1 and the balloon catheter 2 are stretched into the body and conveyed to the heart valve needing to be replaced, and the developing points 11 at the two ends of the measuring balloon are tracked through dynamic CT images to complete the positioning of the measuring balloon 1. The balloon catheter 2 is injected with a liquid using the pressure control device 3, and the balloon 1 is measured in vivo to increase the pressure and expand the radius. When the dynamic CT image observation and measurement balloon 1 is expanded to be completely contacted with the valve ring, pressurization is completed, and the pressure increase is stopped. The pressure tester 4 measures the pressure in the current measurement balloon 1, and the pressure reading dial 41 reads out the pressure value. The position reached by the pointer on the pressurizing device is observed, and the size of the valve to be implanted is finally obtained according to the reading in the valve size scale 31. And pumping out the liquid in the balloon catheter 2 by using the pressure control device 3, measuring the contraction of the balloon 1, reducing the radius, returning along the original path, taking out the balloon, and finishing the valve measurement. The reference 5 in fig. 2-3 is the vessel wall or ventricular wall structure at the valve.

The balloon type heart valve in-vivo measurement device of the embodiment completes measurement of the size of the heart valve in the operation, provides accurate reference for size selection of the implanted valve, avoids new operation wounds and reduces the complexity of the operation.

The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.