Sinus stent delivery system

Abstract

The present application relates to a kind of cerebral venous sinus stents, by inner rod, outer sheath and Y valve, inner rod is by the support rod located in proximal end and the guide wire cavity tube located in distal end is constituted. Outer sheath is made of proximal end sheath tube and distal end sheath tube. Outer sheath is fixedly connected with Y valve, and inner rod can slide in outer sheath and Y valve. Cerebral venous sinus stent is installed in the space between the guide wire cavity tube and distal end sheath tube located in the distal end of delivery system. Two pressure sensors are installed on the guide wire cavity tube, and are located at the distal end and proximal end of the stent installation area respectively. Two sensors can monitor the pressure gradient in cerebral venous sinus before, during and after stent implantation, compared with the traditional microcatheter pressure gradient measurement method, which simplifies the surgical procedure, saves the operation time and protects the life and health of patients.

Description

Technical Field

[0001] This invention relates to a medical device, and more particularly to a sinus venous stent delivery system. Background Technology

[0002] Venous sinus stenosis can lead to increased intracranial pressure, causing chronic moderate to severe headaches, optic disc edema, and decreased vision. Stent placement at the site of venous sinus stenosis is highly effective in relieving headaches and vision loss caused by this idiopathic intracranial hypertension. Before stent placement, the pressure gradient across the stenosis needs to be measured. Stent placement is most effective when the pressure gradient between the distal and proximal ends of the stenosis is greater than 8–10 mmHg. Currently, the common practice is to measure the pressure gradient using a microcatheter. The pressure at both the distal and proximal ends of the stenosis needs to be measured before stent placement. After stent placement, a second measurement using a microcatheter is required to confirm that the normal pressure gradient has been restored after the stent opened the stenosis. The pressure gradient measurement and stent placement are performed separately, making the procedure quite complex and time-consuming. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a sinus venous stent delivery system, which integrates a pressure measuring device. Using the delivery system, pressure gradient measurement before implantation, stent implantation, and pressure gradient measurement after implantation can be completed, simplifying the surgical procedure and facilitating the surgical operation.

[0004] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: a sinus venous stent delivery system is provided, comprising an inner rod, an outer sheath, and a Y-valve. The inner rod consists of a support rod located at the proximal end and a guidewire lumen located at the distal end; the outer sheath consists of a proximal sheath and a distal sheath; the outer sheath is fixedly connected to the Y-valve, and the inner rod can slide within the outer sheath and the Y-valve; the sinus venous stent is installed in the space between the guidewire lumen and the distal sheath located at the distal end of the delivery system, and two pressure sensors are installed on the guidewire lumen, located at the distal and proximal ends of the stent installation area, respectively.

[0005] The pressure sensor consists of a sensor and a protective housing. A slot in the housing allows the sensor to communicate with the outside environment. A lead wire is connected to the proximal end of the sensor, extending through an inner rod to an interface at the proximal end of the inner rod. This interface connects to a transmitter, which transmits the pressure signal to an external display device. The pressure sensor's sensor can be piezoelectric or optical.

[0006] Preferably, the lead wire has a dedicated cavity within the guide wire lumen assembly of the inner rod.

[0007] Preferably, the distal sheath covering the pressure sensor has an opening, allowing the pressure sensor to directly contact the blood in the lumen.

[0008] The guidewire lumen assembly features distal and proximal radiopaque markers. The proximal radiopaque marker also serves as a stent fixation point, and the distal end of the distal sheath also has a radiopaque marker. The sinus venous stent is installed between the proximal and distal radiopaque markers. When the sheath compresses the stent, the sinus venous stent is fixed and prevented from moving by the proximal radiopaque marker. When the sheath is removed, the stent can be released from the delivery system. The sinus venous stent is 40-60 mm in length and 6 / 7 / 8 mm in diameter.

[0009] Preferably, the guidewire lumen has a coil structure to increase its flexibility. The distal end of the guidewire lumen has a soft tip with an inner lumen to prevent vascular injury.

[0010] The connection between the distal and proximal sheaths has a quick-change guidewire port, which is connected to the inner lumen of the guidewire lumen.

[0011] The inner rod's support assembly is made of stainless steel tubing, thiocyanate tubing, or steel wire. The support assembly has a handle at its proximal end and connects to the guidewire lumen at its distal end. This delivery system exhibits high proximal stiffness and low distal stiffness, providing good flexibility and pushing performance in tortuous blood vessels.

[0012] A hydrophilic coating is fixed on the outer sheath to reduce frictional resistance during transport.

[0013] The sinus venous stent delivery system of this invention can measure the pressure on both sides of the stenosis before stent implantation using a pressure sensor integrated on the delivery system, thereby confirming the existence of an excessive pressure gradient. During the procedure, changes in the pressure gradient can be monitored in real time during stent implantation to determine whether the stent has effectively opened the stenosis. Postoperatively, the delivery system can also measure whether the pressure gradient has returned to normal. Using this delivery system, the three operations of microcatheter pressure measurement, stent implantation, and re-microcatheter pressure measurement can be completed in one stop, simplifying the surgical procedure and saving surgical time. Attached Figure Description

[0014] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments: Figure 1 Overall structural diagram of the sinus stent delivery system Figure 2 This is a partial schematic diagram of the distal end of the delivery system when the distal sheath slides to a more distal position. Figure 3 This is a partial schematic diagram of the distal end of the delivery system when the distal sheath slides to the proximal side. Figure 4 A schematic diagram of a pressure sensor Figure 5 A schematic diagram showing the connection between the pressure sensor leads and the transmitter and external display device. Figure 6 Schematic diagram of the delivery system when it is located in a narrow area before stent implantation. Figure 7 A schematic diagram of the stent delivery system after implantation. Detailed Implementation

[0015] The present invention will now be further described with reference to the accompanying drawings. Figure 1 The diagram shows the overall structure of a sinus venous stent delivery system. This delivery system 10 has an inner rod 20, an outer sheath 30, and a Y-valve 40. The inner rod has a proximal support rod 21 and a guidewire lumen 22 located distally. The outer sheath 30 is divided into a proximal sheath 31 and a distal sheath 32. A quick-exchange guidewire port 33 is located between the proximal and distal sheaths. The guidewire 50 can be led out from the quick-exchange guidewire port 33 through the guidewire lumen 22. The outer sheath 30 and the Y-valve 40 are fixedly connected. The inner rod 20 can slide within a certain range within the outer sheath 30 and the Y-valve. The Y-valve has a main lumen 41 and a secondary lumen 42. The inner rod is located within the main lumen 41. The secondary lumen 42 is used for injecting saline. The valve 43 is used to fix the relative position of the inner rod and the outer sheath. The support rod 21 at the proximal end of the inner rod has a handle 211. The guidewire lumen has contrast markers, 232 fixed distally and 231 proximally. The space between the two contrast markers is the installation area for the sinus stent. The sinus stent is 40-60 mm long, and the preferred stent diameter is 6 / 7 / 8 mm. Pressure sensors 24 are installed on the guidewire lumen, namely a distal pressure sensor 242 and a proximal pressure sensor 241. A flexible tip 25 is fixed to the distal end of the guidewire lumen 22. The sensor 24 has a lead wire 26 that extends proximally along the inner rod and finally protrudes from the inner rod. The support rod 21 is a stainless steel tube, a hyaluronic acid tube, or a steel wire, and its distal end is connected to the guidewire lumen 22. A hydrophilic coating is fixed on the outer sheath 30 to reduce frictional resistance during delivery. The delivery system 10 has high proximal stiffness and low distal stiffness.

[0016] The diagram shows the position when the outer sheath and inner rod slide to the distal end of the outer sheath. Figure 2 At this point, the distal sheath can cover the stent placement area on the guidewire lumen 22. When a sinus stent is installed, the stent is in a compressed state. The delivery system is in the same state as before the stent was deployed. The distal end of the distal sheath 32 has a contrast marker 321, which is close to the distal contrast marker on the inner rod. The distal sheath has an opening 322 for exposing the sensor to the blood to measure blood pressure.

[0017] Moving the relative positions of the inner rod and outer sheath allows the outer sheath to be moved proximally. This maneuver controls the deployment of the sinus stent. When the outer sheath is moved to the proximal end, the stent placement area can be fully exposed, such as... Figure 3As shown. The proximal pressure sensor 241 is located on the proximal side of the proximal radiopaque marker. The distal pressure sensor 242 is located on the distal side of the distal radiopaque marker. To improve the flexibility of the guidewire lumen 22, the guidewire lumen includes a flexible coil structure 221.

[0018] Figure 4 The diagram illustrates the structure of a pressure sensor. The pressure sensor has a protective housing 273 with an opening 274. Inside the housing is a pressure sensor 271 for sensing changes in pressure signals. The sensor can be piezoelectric or optical. The sensor has leads 26 for data transmission.

[0019] Figure 5 The diagram illustrates the lead wire extending from the inner rod support rod 21 and connecting to the transmitter 70 via interface 261. The transmitter 70 transmits pressure signals to an external display device 75. The transmitter and external display device can be connected via transmission cable 74 or wirelessly. The transmitter 70 includes a locking device 71 to secure the connection between the lead wire and the transmitter. The transmitter has a switch 72 and an indicator light 73 for controlling and indicating the transmitter's operating status, respectively. The lead wire 26 has a dedicated cavity within the inner rod, ensuring it does not interfere with the guide wire 50 within the guide wire cavity.

[0020] A schematic diagram of the delivery system delivering the product to the narrowed venous sinus is shown below. Figure 6 As shown. The arrows indicate the direction of blood flow. The narrowing region 81 of the venous sinus 80 may lead to an increase in the pressure gradient within the venous sinus. At this time, the pressure difference sensed by the distal pressure sensor 242 and the proximal pressure sensor 241 is the pressure gradient. When the pressure gradient meets the surgical indications, stent implantation can be performed.

[0021] By retracting the outer sheath proximally, the venous sinus stent can be released. After the distal sheath 32 is retracted posteriorly, the guidewire lumen 22 is exposed. Figure 7 This is a schematic diagram of the sinus venosus stent 90 after deployment. After deployment, the stent opens up the narrowed area, and the pressure gradient decreases as blood flow becomes unimpeded. The distal pressure sensor 242 and the proximal pressure sensor 241 can monitor the pressure changes, confirming that the pressure gradient has returned to normal levels post-operatively.

[0022] In clinical use, this sinus venous stent delivery system can complete preoperative pressure gradient measurement, intraoperative stent release and pressure gradient monitoring, and postoperative pressure gradient measurement in one stop. This device optimizes the traditional method of measuring pressure gradient using microcatheters, simplifies the surgical procedure, saves surgical time, and better protects the patient's life and health.

Claims

1. A sinus venous stent delivery system, comprising an inner rod, an outer sheath, and a Y-valve, wherein the inner rod comprises a support rod at a proximal end and a guidewire lumen at a distal end; the outer sheath comprises a proximal sheath and a distal sheath; the outer sheath is fixedly connected to the Y-valve, and the inner rod is slidable within the outer sheath and the Y-valve; the sinus venous stent is installed in the space between the guidewire lumen and the distal sheath at the distal end of the delivery system, characterized in that... Two pressure sensors are installed on the guidewire lumen, located at the distal and proximal ends of the support mounting area, respectively. Each pressure sensor has a sensor and a protective shell. The protective shell has a slot to allow the sensor to communicate with the outside. A lead wire is connected to the proximal end of the sensor. The lead wire extends through the inside of the inner rod to an interface at the proximal end of the inner rod. The interface connects to a transmitter, which transmits the pressure signal to an external display device. The lead wire has a dedicated channel within the guidewire lumen assembly of the inner rod. The guidewire lumen has a coil structure. The distal end of the guidewire lumen has a flexible tip with an inner lumen. The distal sheath has an opening. When the relative position of the outer sheath and the inner rod slides to the distal end of the outer sheath, the distal sheath can cover the support mounting area on the guidewire lumen. The opening on the distal sheath allows the sensor to be exposed to the blood for blood pressure measurement.

2. The sinus stent delivery system according to claim 1, characterized in that... The pressure sensor's sensor can be piezoelectric or optical.

3. The sinus stent delivery system according to claim 1, characterized in that... The guidewire lumen has distal and proximal imaging markers. The proximal imaging marker also serves as a stent fixation point. The distal end of the distal sheath also has an imaging marker. The sinus venous stent is mainly installed between the two imaging markers. The sinus venous stent is 40-60 mm long and 6 / 7 / 8 mm in diameter.

4. The sinus stent delivery system according to claim 1, characterized in that... The connection between the distal and proximal sheaths has a quick-change guidewire port, which is connected to the inner lumen of the guidewire lumen.

5. The sinus stent delivery system according to claim 1, characterized in that... The inner rod's support rod is made of stainless steel tubing, hyaluronic acid tubing, or steel wire. The support assembly has a handle at the proximal end, and the distal end of the support rod is connected to the guide wire cavity.

6. The sinus stent delivery system according to claim 1, characterized in that... A hydrophilic coating is fixed on the outer sheath.

Images