CN115721278B - Sacculus inflation pipe with pressure monitoring function - Google Patents
Sacculus inflation pipe with pressure monitoring function Download PDFInfo
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- CN115721278B CN115721278B CN202211567127.2A CN202211567127A CN115721278B CN 115721278 B CN115721278 B CN 115721278B CN 202211567127 A CN202211567127 A CN 202211567127A CN 115721278 B CN115721278 B CN 115721278B
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Abstract
The invention relates to a balloon dilation catheter with a blood pressure monitoring function, which is provided with a catheter and a balloon. The catheter consists of an inner tube and an outer tube, wherein the inner tube is sleeved in the inner cavity of the outer tube. The inner cavity of the inner tube is an instrument passage, and the inner cavity of the outer tube is provided with a liquid passage channel which can pass through contrast agent. The saccule is communicated with the liquid path channel, and the expansion and the contraction of the saccule can be controlled by controlling the liquid inlet amount. The distal end and the proximal end of the balloon are respectively provided with a pressure sensor, and the sensors are fixed on the inner tube or the outer tube. The pressure sensor can monitor the blood pressure at two ends of the balloon in real time and transmit the blood pressure to the pressure signal monitor through the transmission line and the pressure signal transmitter. By monitoring the blood pressure at the two ends of the balloon, the working state of the balloon and the hemodynamic change condition in the blood vessel can be evaluated, references are provided for factors such as the degree of balloon expansion, the expansion times, the expansion time and the like, and the operation and the flow are optimized.
Description
Technical Field
The invention relates to a medical instrument, in particular to a balloon dilation catheter for interventional therapy.
Background
The balloon dilation catheter has wide application in the field of interventional therapy, and has the functions of dilating blood vessels, blocking blood flow and the like. For atherosclerosis stenosis, the saccule dilating catheter can be spread at the stenosis part to achieve the effect of dilating the stenosis part and opening the blood vessel. The balloon may be coated with a drug to inhibit restenosis. Balloon dilation catheters may also be used to dilate a release stent at a stenosed site. In the field of nerve intervention, the balloon dilation catheter not only can open atherosclerosis stenosis of neck and intracranial arteries, but also can play roles in assisting embolization of an aneurysm inner spring ring, assisting dilation of an intracranial stent, intracranial venous system stenosis and the like. The balloon guiding catheter has a similar structure to the balloon dilating catheter, and can temporarily block and suck blood flow during the treatment of the distal instrument so as to prevent distal embolism.
The main structures of balloon dilation catheters include delivery catheters and balloons. The delivery catheter is divided into an outer tube and an inner tube, the inner tube is used for passing through other instruments such as a guide wire, the inner cavity of the outer tube is communicated with the balloon, and contrast agent can be injected to expand the balloon. The balloon is positioned at the distal end of the delivery catheter and is typically attached to the delivery catheter by thermal or laser welding.
For atherosclerotic stenosis or intracranial venous system stenosis, if the distal side branch of the patient's stenosis portion circulates well, the far-and-near pressure difference at the stenosis portion is not large even if the stenosis degree is serious, and the necessity of the patient to perform a stent operation needs to be considered. An effective method is to use a pressure guidewire to measure the pressure at the distal and proximal ends of the stricture for evaluation of the surgical procedure. But this approach increases the procedure time and cost, as well as the procedure risk, as well as the contrast agent and radiation frequency. In addition, when the stricture site is harder in texture, multiple balloon expansions may be required. The limited vascular opening effect may be caused by the small number of expansion times, and the risk of vascular rupture is increased due to the large number of expansion times. Therefore, how to simply and effectively evaluate the hemodynamic effect after each balloon expansion is also a problem to be solved. Intraoperative imaging only determines the effect of blood flow restoration, but cannot monitor blood pressure near the lesion site.
When the balloon of the balloon dilation catheter is expanded, blood flow is blocked, and the blood flow dynamics in the blood vessel are changed. When collateral circulation at the distal end of the blocking site is abundant, blood supply to the distal blood vessel may be less affected. When the collateral circulation of the blood vessel at the far end of the blocking part is limited, the blood flow at the far end can be obviously reduced by the expansion of the balloon, and the blood pressure at the far end is reduced, so that if the expansion time of the balloon is too long or the suction force of the balloon guiding catheter is too large, the ischemia of the tissue at the far end can be aggravated, and a certain danger is caused. How to optimize the degree and time of balloon dilation also requires monitoring of blood pressure near the lesion site. Therefore, the existing balloon dilation catheter cannot detect the blood pressure of the far end and the near end of the balloon in real time during treatment, and the degree, the times and the time of balloon dilation cannot be optimized, so that the effect of balloon treatment is affected.
Disclosure of Invention
The invention aims to provide the balloon dilation catheter with the blood pressure monitoring function, so that the balloon dilation catheter can measure the blood pressure at the proximal end and the distal end of the balloon in real time, the stenosis degree of a stenosis part is conveniently estimated, or the collateral circulation state of a blood vessel at the distal end of the balloon release position is conveniently estimated, and the influence of the balloon on the blood flow dynamics during working can be mastered in real time.
In order to solve the technical problems, the technical scheme of the invention is as follows:
The balloon dilation catheter is provided with a catheter and a balloon, wherein the catheter is provided with an inner tube and an outer tube, the outer diameter of the inner tube is smaller than the inner diameter of the outer tube, and the inner tube is sleeved in the inner cavity of the outer tube; the inner cavity of the inner tube is an instrument passage which can be used for diagnosis or treatment of the instrument through a guide wire, other catheters with smaller sizes or other interventional instruments; the cavity of the outer tube cavity which does not contain the inner tube is a liquid path channel and can pass through physiological saline containing developer; the saccule is communicated with the liquid path channel, and the expansion and the contraction of the saccule can be controlled by controlling the liquid inlet amount; the distal end and the proximal end of the balloon are respectively provided with a pressure sensor, and the sensors are fixed on the inner tube or the outer tube. Optionally, both the proximal and distal ends of the balloon may be connected to an outer tube with through holes in the wall of the region of the outer tube where the balloon is mounted, facilitating filling of the balloon with contrast agent through the through holes. The pressure sensors at the proximal and distal ends of the balloon are both mounted on the outer tube. Alternatively, the distal end of the inner tube may also extend beyond the outer tube, in which case the proximal end of the balloon is attached to the outer tube, the distal end of the balloon is attached to the inner tube, the distal end of the outer tube is in direct communication with the balloon lumen, the pressure sensor at the proximal end of the balloon is mounted on the outer tube, and the pressure sensor at the distal end of the balloon is mounted on the inner tube.
Optionally, the distal end of the inner tube exceeds the outer tube, the proximal end of the balloon is connected to the outer tube, the distal end of the balloon is connected to the inner tube, the distal end of the outer tube is directly communicated with the inner cavity of the balloon, the pressure sensors at the proximal end and the distal end of the balloon are both arranged on the inner tube, and the outer tube is provided with a through hole which can separate the pressure sensor at the proximal end of the balloon, which is positioned on the inner tube, from the liquid path of the inner cavity of the outer tube and is directly communicated with the outside.
Alternatively, the inner tube of the balloon dilation catheter may be in a rapid exchange format with the inlet to the lumen located in the outer tube side wall. Other instruments such as guide wires can directly enter or withdraw from the inner tube through the inlet of the side wall of the outer tube, so that the operation is convenient. The proximal port of the balloon dilation catheter is in communication with the outer lumen for injection of contrast medium within the tube and balloon.
Optionally, the proximal end of the balloon dilation catheter has a Y-shaped interface, one way of which is in communication with the lumen of the inner tube for use with other interventional diagnostic or therapeutic instruments. The other path of the interface is communicated with the inner cavity of the outer tube and is used for injecting contrast medium into the saccule. The pressure sensor is connected with a transmission line which extends to the proximal end of the balloon dilation catheter in the lumen or the pipe wall of the inner pipe or the outer pipe. The manner of extension within the lumen or wall of the tube may be straight or spiral or cross-coiled. The transmission line is connected with the pressure signal transmitter through the signal interface, and the pressure signal transmitter can transmit the pressure signal to the display device in a wireless or wired mode.
The pressure sensor is provided with a protective shell, the induction part of the pressure sensor is positioned in the protective shell, and the protective shell is fixed on the conveying catheter in a crimping or gluing mode. The protective housing has the through-hole for the inside induction part of pressure sensor passes through the through-hole and external UNICOM.
The outer tube or the inner tube of the balloon dilation catheter is provided with a developing mark, some developing marks are positioned in the area where the balloon is positioned and used for marking the position of the balloon, and other developing marks are positioned on the catheter and used for marking the position of the catheter.
The inner tube and the outer tube of the balloon dilation catheter are formed by compounding polymers, metals or metals and polymer materials, have good conveying performance, are more flexible at the distal end than at the proximal end, and are coated with hydrophilic coatings at the outer side of the outer tube.
For the lesions of the vascular stenosis, the balloon dilation catheter can omit the use of a pressure guide wire, and after the balloon reaches the lesion position, the blood pressure at the two ends of the stenosis can be monitored without opening the balloon, so that the collateral circulation condition at the far end of the lesion position is judged. When interventional therapy is needed, the balloon is directly opened for balloon expansion or balloon auxiliary stent expansion, so that the steps and time of operation are saved. Multiple balloon expansions may be required during treatment, where pressure sensors at both ends of the balloon may evaluate changes in hemodynamics after each expansion in real time, optimizing the number of expansions, and reducing complications.
The balloon dilation catheter with the blood pressure monitoring function can judge the blood pressure at the two ends of the balloon after blood flow is blocked, and further judge the intensity of the lateral branch circulation at the far end of the blocking part. If the distal blood pressure is low, or the pressure differential between the proximal and distal ends is large, this indicates a weak collateral circulation. The time of blocking blood flow by the balloon can be controlled, or the degree of balloon expansion is reduced to recover partial blood supply, or intermittent balloon blocking operation is performed, so that the risk of ischemic necrosis of the distal tissue is reduced.
In general, the balloon dilation catheter disclosed by the invention can measure the blood pressure at two ends of the balloon in real time when the balloon works, so that the influence of the balloon on the hemodynamics is mastered in real time, a reference is provided for a treatment strategy of diseases, an operator can determine the degree of balloon dilation, the dilation time and the dilation times according to the treatment state and the blood pressure at two ends of the balloon, and the treatment scheme of the balloon is optimized, so that a patient obtains greater benefit.
Drawings
The invention is described in further detail below with reference to the attached drawings and detailed description:
FIG. 1 is a rapid exchange balloon dilation catheter with a proximal sensor located on an outer tube and a distal sensor located on an inner tube
FIG. 2 is a rapid exchange balloon dilation catheter with both proximal and distal sensors located in the inner tube
FIG. 3 is a balloon dilation catheter with both proximal and distal pressure sensors located on the outer tube
FIG. 4 is a diagram showing the connection of a balloon dilation catheter to a pressure signal transmitter and pressure signal monitor
Fig. 5 is a schematic perspective view of a balloon dilation catheter
FIG. 6 is a schematic diagram of a pressure sensor mounted on a catheter
FIGS. 7a-c are schematic illustrations of a balloon dilation catheter with blood pressure monitoring for treatment of atherosclerotic stenosis
FIGS. 8a-c are schematic illustrations of temporary blood flow occlusion and aspiration of a balloon dilation catheter with blood pressure monitoring
Detailed Description
The balloon dilation catheter with blood pressure monitoring function of the present invention is further described below with reference to the accompanying drawings. Fig. 1 shows a balloon dilation catheter 10 having a balloon 11 and a catheter 20. Catheter 20 has an outer tube 21 and an inner tube 22. The outer diameter of the inner tube 22 is smaller than the inner diameter of the outer tube 21, and the inner tube 22 is located in the lumen of the outer tube 21. In this embodiment, the balloon dilation catheter 10 is in a rapid exchange format with the rapid exchange inlet 222 of the inner tube 22 being located on the wall of the outer tube 21. The inner tube 22 is an instrument passageway through which the inner tube lumen 221 may pass a guidewire, microcatheter, or other interventional diagnostic and therapeutic instrument that may be advanced into or withdrawn from the inner tube lumen 222 from the rapid exchange portal 222. The inner tube 22 may have a plurality of quick-change inlets 222, only one of which is shown in fig. 1, but one embodiment thereof. Catheter tip 26 is soft and smooth to reduce vascular trauma and resistance to advancement. The proximal end of the catheter 20 has a strain relief tube 27 and is connected to the proximal end interface 27. The inner lumen of the outer tube 21 is 221, which is a fluid passage through which contrast agent may pass. The distal end of the outer tube communicates with the interior of the balloon through interface 43, and contrast media may be injected or withdrawn for inflation and deflation of the balloon. The port 43 is a luer port and is connected to a pressure injection pump. The catheter 20 has a length that facilitates delivery of the balloon 11 to a site within a body vessel where treatment is desired.
The inner tube 22 and the outer tube 21 of the catheter 20 are manufactured using conventional interventional catheter procedures. The conduit material may be a metal or plastic tube or a composite tube of a metal material and a plastic material. The metal tube wall may be cut with lines to increase flexibility. The inner layer of the common composite pipe is polytetrafluoroethylene, the middle layer is a metal braided wire or a spiral spring, and the outer layer is made of polyurethane or Pebax material. To increase the stiffness of the tubing, wires or metal rods may be added to the catheter to increase the delivery properties of the tubing. The catheter is made progressively more flexible from the proximal end to the distal end by adjusting the diameter of the tubing, the hardness of the plastic material, the density, size and strength of the metal reinforcing structure. The outer tube 21 is coated with a hydrophilic coating on the outside to reduce friction with blood vessels and other access instruments.
A balloon 11 is connected to the distal end of the balloon guiding catheter 10. The balloon 11 is connected to the catheter 20 by laser welding, thermal welding, bonding, or the like. In this embodiment, the distal end of the inner tube 22 extends beyond the outer tube 21, the distal end of the balloon 11 is attached to the inner tube 22, and the proximal end of the balloon 11 is attached to the outer tube 21. The proximal end of the balloon 11 is communicated with the inner cavity 211 of the outer tube, and the rest parts are closed. The balloon 11 may be a compliant balloon or a non-compliant balloon. The shape of the balloon 11 is not particularly limited, and in the embodiment of fig. 1, the balloon is a shuttle shape or an ellipsoid with a long axis, and in the embodiment of fig. 3, the balloon is an ellipsoid having a nearly spherical shape, and in addition, the balloon may have various shapes such as a spiral ripple shape, a multi-cavity balloon, and the like. Preferred balloon diameters are 1.5mm, 1.75mm, 2mm, 2.25mm, 2.5mm, 3mm, 3.5mm, 4mm, 5mm, 6mm, etc. Preferred balloon lengths are 10mm, 12mm, 15mm, 20mm, 30mm, etc. The balloon diameter and balloon length may be combined with each other to accommodate different vessel anatomy and lesion plaque shapes.
In the embodiment of fig. 1, the proximal and distal ends of the balloon 11 have pressure sensors, distal pressure sensor 32 and proximal pressure sensor 31, respectively. The pressure sensor is mounted on the conduit 20. Specifically, in the present embodiment, a distal pressure sensor 32 is mounted on the inner tube 22, and a proximal pressure sensor 31 is mounted on the outer tube 21. The distance from the distal pressure sensor 32 to the point of attachment of the distal end of the balloon to the catheter 20 is not limited, such as, optionally, 0-200mm, preferably, between 0-10 mm. The distance from the proximal pressure sensor 31 to the proximal end of the balloon to the catheter 20 is not limited, such as optionally between 0-200mm, preferably between 0-10 mm. The pressure sensor has a transmission line extending proximally of the catheter within the wall or lumen of the catheter 20 in a straight or helically coiled or cross coiled manner. The number of preferred transmission lines per sensor is 3. The transmission line extends out of the catheter at the proximal end of the catheter 20 and is grouped into a transmission line 33 having a signal transmission interface 34 at its distal end. A developing marker 25 is mounted on the inner tube for marking the position of the balloon under X-rays.
Fig. 2 depicts another balloon dilation catheter with blood pressure monitoring function. The difference from the embodiment of fig. 1 is that a pressure sensor 31 at the proximal end of the balloon is also mounted on the inner tube 22. The outer tube 21 is provided with a through hole 212 at the position where the proximal sensor 31 is mounted, and the through hole 212 is directly connected to the inner tube 22, so that the sensor 31 can directly measure the external pressure. The through holes 212 also ensure that contrast agent in the outer tube lumen 211 does not leak out of the outer tube 21 through the through holes 212.
The balloon dilation catheter illustrated in fig. 3 has pressure sensors at both the balloon proximal and distal ends mounted on an outer tube 21. In this embodiment, the inner tube 22 is a conventional hub, with the proximal end of the inner tube extending to the proximal Y-shaped hub 40 of the catheter 20 as is the proximal end of the outer tube. The inner tube 22 is connected to the hub 41 of the Y-shaped hub, and other interventional instruments enter and withdraw the inner tube from the hub 41. The inner lumen 211 of the outer tube 21 communicates with the other port 42 of the Y-port. Contrast medium is injected into the outer tube lumen 211 through the port 42 and into the balloon through the through hole 23 to expand it.
Fig. 4 illustrates the manner in which the balloon dilation catheter is connected to a pressure signal transmitter 54 and a pressure signal monitor 56. The transmission line signal interface 34 is secured to the pressure signal transmitter 54 by a rotational securing device 51. The transmission line 33 is connected to the pressure signal transmitter 54 by locking the rotational fixture 51. The rotary fixture 51 is released and the transmission line is separated from the pressure signal transmitter. The pressure signal transmitter has a switch 53 thereon for controlling whether the pressure signal transmitter is operating. The indicator light 52 is used to indicate the operating state of the pressure signal transmitter. The pressure signal transmitter is connected to a pressure signal monitor 56 by a wire 55. In other preferred embodiments, the pressure signal transmitter 54 may also be connected to the pressure signal monitor 56 by wireless means. The pressure signal monitor 56 is used to output and display pressure waveforms, and to display the waveforms of the two pressure signals on the screen in real time, and to calculate the diastolic pressure, systolic pressure and mean arterial pressure. The pressure signal monitor 56 has an alarm function when the pressure signal is abnormal.
Fig. 5 illustrates a perspective view of a balloon dilation catheter. The schematic balloon dilation catheter of fig. 1-4 is a schematic cross-sectional view. In the balloon dilation catheter shown in fig. 5, the outer tube and inner tube are not labeled for simplicity, and only catheter 20 is labeled. There is a pressure sensor 32 at the distal end of the balloon 11 and a pressure sensor 31 at the proximal end of the balloon 11.
Fig. 6 is a schematic diagram of the connection of the pressure sensor 30 to the catheter. The pressure sensor 30 has a sensing portion 35 for sensing a blood pressure signal. The protective case 38 serves to protect the sensing portion 35 from other contact stresses. The pressure sensor 30 has a transmission line 37, and in this embodiment, the transmission line 37 has three leads. After being led out from the pressure sensor 30, the transmission line 37 is buried in the wall of the outer tube 21. In other embodiments, the transmission line may also be located in a transmission line cavity dedicated in the outer tube. The transmission line 37 may extend proximally in a straight line, spiral, or cross-coiled manner within the outer tube 21. The protective shell 38 is provided with a through hole 36, and the sensing part 35 is communicated with the external environment. The normal direction of the sensor may be parallel or perpendicular to the direction of the through hole 36 or at an angle to the direction of the through hole. In the schematic view of fig. 6, the through hole 35 is designed to be large for convenience of illustration. In other preferred embodiments, the through hole 36 may be in the shape of a small slit, so as to reduce the contact of the sensor 35 with the outside, thereby interfering with the blood pressure signal. There may be a plurality of through holes 36 in the protective shell 38. The protective case 38 is made of metal, and is connected to the outer tube 21 by crimping, bonding, riveting, or the like. In the embodiment of fig. 6, the protective shell 38 is cylindrical in shape with an outer diameter comparable to the outer diameter of the outer tube. In other alternative embodiments, such as when the tube diameter of the outer tube 21 is large, the protective shell 38 may occupy only a portion of the outer tube circumference, rather than being 360 degrees around, as shown in FIG. 8 a. The sensing part is isolated from the passage in the lumen by a partition board or a sealing glue.
The balloon dilation catheter with blood pressure monitoring function of the present invention is further described below in connection with a specific application scenario. Figures 7a-7c illustrate the operation of a balloon dilation catheter in a blood vessel having atherosclerosis. The blood vessel 60 has an atherosclerotic plaque 61 therein. The balloon dilation catheter is delivered within the vessel lumen to the stenosed site. Such that distal sensor 32 is farther than the stenotic plaque, proximal sensor 31 is closer to the stenotic plaque, and balloon 11 is capable of covering the length of plaque 61 in length. In fig. 7a, the balloon 11 is in a contracted state. The balloon in the collapsed state is folded over the catheter 20 like an umbrella when collapsed. The distal pressure sensor 32 is capable of sensing the blood pressure P2 distal to the plaque and the proximal pressure sensor 31 is capable of sensing the blood pressure P1 proximal to the plaque. By P1 and P2, the collateral circulation intensity and distal blood supply distal to the plaque can be assessed. When P2 is much smaller than P1, indicating poor collateral circulation, the stenosed plaque has severely affected blood supply to the distal tissue, requiring balloon dilation or stent release. When P2 is only slightly smaller than P1, indicating that even if there is a stenosis, the distal collateral circulation is good and the distal tissue is still able to maintain a more adequate blood supply, then there may be no need to release the stent.
Fig. 7b shows a schematic of the balloon expanding plaque. Fig. 7c shows a schematic view of the balloon after it has been inflated and contracted again, the vessel having been opened to some extent. In the actual treatment process, multiple balloon expansions are sometimes required to achieve the ideal vascular opening effect. Pressure changes in blood vessels are acquired in real time through pressure sensors at the near end and the far end, so that the optimization of treatment strategies is facilitated, the optimal balloon expansion degree and the optimal balloon expansion times are used, the optimal vascular opening result is achieved, and related complications are reduced.
Figures 8a-8c illustrate the operation of another balloon dilation catheter. The inner tube of the balloon dilation catheter is used to deliver other interventional instruments 64, such as microcatheters and thrombolytic stents. Such balloon dilation catheters are also known as balloon guide catheters. These devices open a distally occluded vessel, which may cause emboli to fall off and form a distal plug if the proximal blood flow is not controlled. The balloon of such a balloon-guided catheter may be expanded, as shown in fig. 8b, blocking proximal blood flow, thereby reducing distal embolic complications. However, blocking proximal blood flow presents some problems. If the collateral circulation of the distal blood vessel is poor, the blood vessel branch 63 is collateral circulation in the schematic diagram, which may result in a greater influence on the blood supply to the distal tissue. This is the degree to which the pressure sensors at the proximal and distal ends of the balloon can sense the blood pressure at the proximal and distal ends of the balloon, and thereby determine the affected blood supply at the distal end. If the remote blood supply is greatly affected, prompt the need to shrink the saccule in time, restore the blood supply or accelerate the operation progress. In addition, during a thrombolysis procedure, the balloon guiding catheter requires auxiliary aspiration, as shown in fig. 8c. The remote pressure sensor can evaluate the strength of the suction force through blood pressure monitoring, so that the suction operation is optimized.
Claims (7)
1. The balloon dilation catheter is provided with a catheter and a balloon, wherein the catheter is provided with an inner tube and an outer tube, the outer diameter of the inner tube is smaller than the inner diameter of the outer tube, and the inner tube is sleeved in the inner cavity of the outer tube; the inner cavity of the inner tube is an instrument passage which can be used for diagnosis or treatment of the instrument through a guide wire, other catheters with smaller sizes or other interventional instruments; the cavity of the outer tube cavity which does not contain the inner tube is a liquid path channel and can pass through contrast agent; the saccule is communicated with the liquid path channel, and the expansion and the contraction of the saccule can be controlled by controlling the liquid inlet amount; the balloon is characterized in that the distal end and the proximal end of the balloon are respectively provided with a pressure sensor, and the sensors are fixed on the inner tube or the outer tube;
the pressure sensor is provided with a protective shell, and the protective shell is provided with a through hole, so that an induction part inside the pressure sensor is communicated with the outside through the through hole;
the distance from the far-end pressure sensor to the connecting point between the far end of the balloon and the catheter is 0-10mm, and the distance from the near-end pressure sensor to the connecting point between the near end of the balloon and the catheter is 0-10 mm;
The pressure sensor is connected with a transmission line, the transmission line extends to the proximal end of the balloon dilation catheter in the lumen or the tube wall of the inner tube or the outer tube, the extension mode can be linear extension, spiral coiling or cross spiral coiling, the transmission line is connected with a pressure signal transmitter through a signal interface, and the pressure signal transmitter can transmit a pressure signal to the pressure signal monitor in a wireless or wired mode;
the balloon dilation catheter can measure the blood pressure at the proximal end and the distal end of the balloon in real time, so that the stenosis degree of a stenosis part can be conveniently evaluated, or the collateral circulation state of a blood vessel at the distal end of the balloon release position can be evaluated, and the influence of the balloon on the hemodynamics can be mastered in real time when the balloon works;
the inner tube and the outer tube are formed by compounding metal and polymer materials, the inner layer of the composite tube is polytetrafluoroethylene, the middle layer is a metal braided wire or a spiral spring, the outer layer is polyurethane or Pebax material, the composite tube has good conveying performance, the far end is more flexible than the near end, and the outer side of the outer tube is coated with a hydrophilic coating.
2. The balloon dilation catheter of claim 1 wherein the proximal and distal ends of the balloon are both connected to an outer tube, the tube wall of the region of the outer tube where the balloon is mounted has a through hole, and the pressure sensors at the proximal and distal ends of the balloon are both mounted to the outer tube.
3. The balloon dilation catheter of claim 1 wherein the inner tube distal end extends beyond the outer tube, the balloon proximal end is connected to the outer tube, the balloon distal end is connected to the inner tube, the outer tube distal end is in direct communication with the balloon lumen, the balloon proximal pressure sensor is mounted on the outer tube, and the balloon distal pressure sensor is mounted on the inner tube.
4. The balloon dilation catheter of claim 1 wherein the distal end of the inner tube extends beyond the outer tube, the proximal end of the balloon is connected to the outer tube, the distal end of the balloon is connected to the inner tube, the distal end of the outer tube is in direct communication with the balloon lumen, the pressure sensors at the proximal and distal ends of the balloon are mounted on the inner tube, and the outer tube has a through hole to block the pressure sensor at the proximal end of the balloon located on the inner tube from the fluid path of the lumen of the outer tube and directly from the environment.
5. The balloon dilation catheter of claim 1 wherein the inner tube is in a rapid exchange configuration with an inlet to the lumen being located on the side wall of the outer tube and a proximal port of the balloon dilation catheter being in communication with the lumen of the outer tube.
6. The balloon dilation catheter of claim 1 wherein the proximal end of the balloon dilation catheter has a Y-shaped interface, one of the interfaces being in communication with the lumen of the inner tube and the other of the interfaces being in communication with the lumen of the outer tube.
7. The balloon dilation catheter of claim 1 wherein the outer tube or inner tube has a visualization mark thereon, wherein the visualization mark is located in an area where the balloon is located for marking the balloon location.
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| CN202211567127.2A CN115721278B (en) | 2022-12-07 | 2022-12-07 | Sacculus inflation pipe with pressure monitoring function |
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| CN202211567127.2A CN115721278B (en) | 2022-12-07 | 2022-12-07 | Sacculus inflation pipe with pressure monitoring function |
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| CN116612673A (en) * | 2023-05-16 | 2023-08-18 | 中国人民解放军总医院第五医学中心 | Simulation system for omnibearing monitoring type aortic balloon occlusion training |
| CN116688328A (en) * | 2023-06-27 | 2023-09-05 | 无锡帕母医疗技术有限公司 | Catheter apparatus and heart failure treatment apparatus |
| CN117771519A (en) * | 2023-12-14 | 2024-03-29 | 北京航空航天大学 | Pressure monitoring and liquid injection active measurement and control system of balloon dilation catheter |
| CN119104192B (en) * | 2024-09-02 | 2025-07-15 | 东莞市迪凯医疗科技有限公司 | Pressure detection method of PTCA balloon catheter and PTCA balloon catheter |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN213406170U (en) * | 2020-08-14 | 2021-06-11 | 中国人民解放军东部战区总医院 | Self-adjusting balloon blocking device |
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| US20060106321A1 (en) * | 2003-01-16 | 2006-05-18 | Galil Medical Ltd. | Device, system, and method for detecting, localizing, and characterizing plaque-induced stenosis of a blood vessel |
| US20150327836A1 (en) * | 2014-05-16 | 2015-11-19 | University Of Virginia Patent Foundation | Endovascular occlusion device and method of use |
| WO2020056428A1 (en) * | 2018-09-14 | 2020-03-19 | The Regents Of The University Of California | Multi-function intravascular catheter for atherosclerosis diagnostics |
| CN110947082B (en) * | 2019-12-02 | 2021-09-24 | 心凯诺医疗科技(上海)有限公司 | Balloon guiding catheter and preparation method thereof |
| US20230309842A1 (en) * | 2020-08-21 | 2023-10-05 | University Of Utah Research Foundation | Occlusion balloons and distal thrombectomy catheters with blood flow sensors and automated inflation |
| CN217525253U (en) * | 2022-04-08 | 2022-10-04 | 北京航空航天大学 | First-aid hemostatic balloon |
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| CN213406170U (en) * | 2020-08-14 | 2021-06-11 | 中国人民解放军东部战区总医院 | Self-adjusting balloon blocking device |
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