CN102160828A - Delivery system for novel bioresorbable slide fastener scaffold - Google Patents

Abstract

The present invention provides a transcatheter delivery device for delivering a novel slider stent to a narrow lumen. The device consists of an outer sheath, inner sheath and balloon catheter. The outer sleeve has a proximal end, a distal end and a lumen extending between the two ends. The inner sheath also has a proximal end, a distal end and a lumen extending between the two ends. The outer diameter of the inner sheath is suitable for slidingly inserting into the lumen of the outer sheath. The balloon catheter also has a proximal end, a distal end, and a lumen, the outer diameter of the balloon catheter being adapted to be slidably inserted into the lumen of the inner sheath. The distal end of the balloon catheter is a balloon, and the length and diameter of the balloon can be selected according to the requirements of the stent; there is a metal marker at each end of the balloon, which can help the positioning of the stent. A cone is attached to the distal end of the balloon to prevent the stent from sliding to the distal end, and the proximal part of the cone can be inserted into the outer sleeve so that the outer surfaces of the cone and the outer sleeve remain at the same level. The inner sheath is slightly shorter than the balloon catheter until it reaches the balloon proximal end of the balloon catheter, which prevents the stent from sliding proximally.

Description

Delivery system of a novel slip-button bioresorbable scaffold

Technical field:

This patent relates to a delivery device for transcatheter implantation of a non-self-expandable sliding buckle stent, a delivery device for dilating narrowed parts of organs such as blood vessels, trachea, esophagus, urethra, and biliary tract.

technical background:

In the field of interventional therapy, for the stenosis of blood vessels, trachea, esophagus, urethra, biliary tract and other organs, stents are usually implanted to expand the stenosis and effectively maintain the lumen. The stent is introduced into the lumen in the unexpanded state, positioned at the stenosis, and then expanded and placed there.

Traditionally, stents can be divided into two types according to their expansion mechanisms: one is self-expanding stents, which are called self-expanding stents, and the stent materials are mainly alloys and polymers with shape memory; Between the inner and outer catheters of the implanter, when it is introduced into the stenosis of the lumen, the outer catheter stent itself expands into the lumen of the stenosis by withdrawing the outer catheter to maintain the smooth flow of the lumen. The other is a balloon-expandable stent. The stent itself has no self-expanding characteristics; the stent is pre-pressed on the balloon and reaches the target lesion along the guiding catheter. The stent is plastically deformed by balloon expansion and tightly attached to the inner wall of the lumen , to maintain the patency of the narrow lumen.

However, in addition to the above two traditional stents, there is a new type of stent recently, which is characterized in that it has no shape memory characteristics, and at the same time, the stent is in the shape of a sheet before expansion, rather than the complete cylindrical shape of the traditional stent, that is, a new type of sliding buckle stent . The expansion mechanism after being introduced into the lumen is neither a self-expandable stent nor a balloon-expandable stent, so neither the self-expandable nor the balloon-expandable stent delivery device is suitable for this new type of stent.

Contents of the invention

The purpose of the present invention is to solve the delivery problem of this new type of stent, and provide a transcatheter delivery device. The device adopts the method of combining the outer sleeve and the balloon catheter, so that the outer layer of the stent will not bounce off before the expansion of the stent. The stent can be accurately positioned, and the stent can be fully expanded by expanding the balloon.

As shown in FIG. 1 , a novel slider stent delivery device according to an embodiment of the present invention is shown. The delivery device consists of an outer cannula, inner sheath and balloon catheter. The outer sleeve has a proximal end, a distal end and a lumen extending between the two ends. The inner sheath also has a proximal end, a distal end and an inner lumen extending between the two ends. The outer diameter of the inner sheath is suitable for slidingly inserted into the cavity of the outer sheath, and the length of the inner sheath is slightly longer than that of the outer sheath. For example, in one embodiment, the inner sheath is about 4-6 cm longer than the outer sheath. The balloon catheter also has a proximal end, a distal end, and a lumen, the outer diameter of the balloon catheter being adapted to be slidably inserted into the lumen of the inner sheath. The distal end of the balloon catheter is a balloon, and the length and diameter of the balloon can be selected according to the requirements of the stent. In a preferred embodiment, there is a metal marker at each end of the balloon, which can help the positioning of the stent. In one embodiment, a cone is attached to the distal end of the balloon to prevent the stent from sliding distally. In one embodiment, the proximal portion of the cone is inserted into the outer sleeve such that the outer surfaces of the cone and the outer sleeve are at the same level. The inner sheath is slightly shorter than the balloon catheter and reaches the proximal balloon end of the balloon catheter, which prevents the stent from sliding proximally. In the embodiment shown in Fig. 1, the delivery device further includes two Y-shaped adapters, one Y-shaped adapter is arranged at the proximal end of the inner sheath to communicate with its lumen; the other Y-shaped adapter is arranged at the proximal end of the outer sheath to communicate with it. The lumen is connected. The role of these two Y-shaped adapters is to infuse and aspirate the required fluid into the lumen during the delivery of the Slider stent, respectively.

By crimping the stent on the balloon and fixing it between the distal cone of the balloon and the proximal inner sheath, the displacement of the stent can be prevented; at the same time, the outer surface of the stent is sheathed in the outer sleeve, which can prevent the outer layer of the stent from expanding . The delivery device equipped with the stent is delivered to the stenotic vessel along the guide wire. After accurate positioning according to the metal marker on the balloon, the overtube is withdrawn, and then the balloon is inflated and expanded. The inner walls of blood vessels. Then withdraw the inner sheath and outer sheath together.

The present invention also provides a kit comprising a sheet-like slider bracket and a delivery system dedicated to the slider bracket. The delivery device consists of an outer sheath, inner sheath and balloon catheter. The outer sleeve has a proximal end, a distal end and a lumen extending between the two ends. The inner sheath also has a proximal end, a distal end and an inner lumen extending between the two ends. The outer diameter of the inner sheath is suitable for slidingly inserted into the cavity of the outer sheath, and the length of the inner sheath is slightly longer than that of the outer sheath. For example, in one embodiment, the inner sheath is about 4-6 cm longer than the outer sheath. The balloon catheter also has a proximal end, a distal end, and a lumen, the outer diameter of the balloon catheter being adapted to be slidably inserted into the lumen of the inner sheath. The distal end of the balloon catheter is a balloon, and the length and diameter of the balloon can be selected according to the requirements of the stent. In a preferred embodiment, there is a metal marker at each end of the balloon, which can help the positioning of the stent. In one embodiment, a cone is attached to the distal end of the balloon to prevent the stent from sliding distally. In one embodiment, the proximal portion of the cone is inserted into the outer sleeve such that the outer surfaces of the cone and the outer sleeve are at the same level. The inner sheath is slightly shorter than the balloon catheter and reaches the proximal balloon end of the balloon catheter, which prevents the stent from sliding proximally. In the embodiment shown in Fig. 1, the delivery device further includes two Y-shaped adapters, one Y-shaped adapter is arranged at the proximal end of the inner sheath to communicate with its lumen; the other Y-shaped adapter is arranged at the proximal end of the outer sheath to communicate with it. The lumen is connected. The role of these two Y-shaped adapters is to infuse and aspirate the required fluid into the lumen during the delivery of the Slider stent, respectively. The flake-shaped integrated sliding buckle bio-stent includes: a flat stent body, the stent body has a mesh structure; a stent head located at one end of the stent body, the stent head is integrally formed with the stent body, and its size is the same as The bracket body is compatible, and the bracket head acts as a sliding buckle during the crimping process of the bracket; and a bracket buckle, the bracket buckle is also integrally formed with the bracket body, and is used for crimping the bracket. Secure the stent into a tubular stent buckle during the process.

The specific delivery process of the delivery device will be described below.

1. As shown in Figure 2, use a pressure pump to suck the balloon into a negative pressure from the proximal end of the balloon catheter, withdraw the outer sleeve to the proximal end, and expose the distal end of the balloon and the inner sheath.

2. As shown in Figure 3, crimp the stent on the balloon, push the outer sleeve to the distal end, and wrap the stent and part of the cone into the outer sleeve.

3. As shown in Figure 4, deliver the stent-loaded delivery device to the target lesion along the guide wire, position it according to the metal mark on the balloon, withdraw the overtube to the proximal end, expose the stent, and pressurize the pressure pump to expand Balloon-releasing stent.

4. As shown in Figure 5, after the stent is fully expanded, the delivery device is completely withdrawn along the guide wire, and the stent remains in the blood vessel to support the blood vessel.

Brief description of the drawings

Fig. 1 shows a schematic diagram of a stent delivery device according to an embodiment of the present invention. In the figure, 1 represents a balloon catheter, 2 represents an inner sheath, 3 represents an outer cannula, 4 represents a cone, 5 represents a balloon, 6 and 7 represent a Y-shaped adapter.

Figure 2 shows a schematic view of proximally withdrawing the outer cannula to expose the distal end of the balloon and inner sheath prior to catheter delivery. In the figure, 1 denotes a balloon catheter, 2 denotes an inner sheath, 3 denotes an outer tube, 4 denotes a cone, and 5 denotes a balloon.

Fig. 3 shows a schematic diagram of the stent being wrapped in the outer sleeve when the stent is crimped on the balloon and the outer sleeve is pushed distally. In the figure, 1 represents a balloon catheter, 2 represents an inner sheath, 3 represents an outer cannula, 4 represents a cone, and 5 represents a balloon and a stent.

Figure 4 shows a schematic diagram of withdrawing the overtube to the proximal end to expose the stent. In the figure, 1 denotes a balloon catheter, 2 denotes an inner sheath, 3 denotes an outer tube, 4 denotes a cone, and 5 denotes a balloon and a stent.

Fig. 5 shows a schematic diagram of withdrawing the delivery device along the guide wire and leaving the stent in the blood vessel after the stent is fully expanded.

Fig. 6 shows an angiographic image of the delivery device delivering the stent to the left common iliac artery of the pig, and after positioning accurately according to the marks on both ends of the balloon, withdrawing the overtube to the proximal end of the balloon catheter.

Fig. 7 shows the contrast images of the balloon-releasing stent pressurized by the pressure pump.

Figure 8 shows the angiogram of the stent vessel remaining open after the delivery device is withdrawn after the stent is released.

Concrete example method

Example 1

In the simulated blood vessel in vitro, a new type of sliding buckle stent delivery device was used to simulate the delivery of polycaprolactone (PCL) edge sliding buckle stents, and the delivery and release of the stents were observed.

1. Materials and methods:

Materials: polycaprolactone (PCL) edge-slip buckle-type stents 20*8mm, 10 each, rubber hoses with a diameter of 6 cm, stent delivery devices, and pressure pumps.

method:

1. Use the pressure pump to suck the balloon of the delivery device into negative pressure, then withdraw the outer sheath tube, curl and wrap the slider brackets on the delivery device balloon respectively, and then push the outer sheath tube forward to the cone to enclose it. stand.

2. Insert the stent delivery device into the target site of the artificial blood vessel along the guide wire, expand and release the stent at 12atm*30 seconds.

3. Suction the balloon back into negative pressure and withdraw the balloon.

2. Observation indicators:

1. Delivery device success rate

Evaluation criteria: successfully delivered to the target site, the stent does not fall off, shift, and can be positioned accurately.

2. Complication rate: whether there is stent displacement, falling off, balloon injury, tearing and blood vessel injury, tearing, etc.

3. Release pressure: measure the pressure when the stent is fully released.

3. Results:

The delivery device releases the stent (10-14atm) under the conventional release pressure. The stent has no displacement, slippage, and complications such as vascular injury and balloon injury. It can be successfully delivered to the target site and can be positioned accurately.

Table 1: Results of PCL edge-slider stent delivered by delivery device

Example 2

In the simulated blood vessel in vitro, a new type of sliding buckle stent delivery device was used to simulate the delivery of polydioxanone (PDO) edge sliding buckle stents, and the delivery and release of the stents were observed.

1. Materials and methods:

Materials: polydioxanone (PDO) edge-slip buckle-type stents 20*8mm, 10 each, rubber hoses with a diameter of 6 cm, stent delivery devices, and pressure pumps.

method:

1. Use the pressure pump to suck the balloon of the delivery device into negative pressure, then withdraw the outer sheath tube, curl and wrap the slider brackets on the delivery device balloon respectively, and then push the outer sheath tube forward to the cone to enclose it. stand.

2. Insert the stent delivery device into the target site of the artificial blood vessel along the guide wire, expand and release the stent at 12atm*30 seconds.

3. Suction the balloon back into negative pressure and withdraw the balloon.

2. Observation indicators:

1. Delivery device success rate

Evaluation criteria: successfully delivered to the target site, the stent does not fall off, shift, and can be positioned accurately.

2. Complication rate: whether there is stent displacement, falling off, balloon injury, tearing and blood vessel injury, tearing, etc.

3. Release pressure: measure the pressure when the stent is fully released.

3. Results:

The delivery device releases the stent (11-15atm) under the conventional release pressure. The stent has no displacement, slippage, and complications such as vascular injury and balloon injury. It can be successfully delivered to the target site and can be positioned accurately.

Table 2: Results of Delivery Device Delivery of PDO Edge Slider Stents

Example 3

In the experimental porcine iliac artery, a new type of sliding button stent delivery device was used to deliver the polycaprolactone (PCL) edge sliding button stent, and the delivery and release of the stent were observed.

1. Materials and methods

Materials: 10 25Kg pigs, puncture needle, guide wire, 7F sheath, Omnipaque, chloramphene, heparin, stent delivery device, pressure pump and GE-2005 angiography apparatus.

Sample content: 10 pigs, 15 PCL sliding buckle brackets 20*8mm.

Specific steps and methods: (see Figure 6, 7, 8)

1. Pigs were anesthetized with 10 mg/Kg of chloramphenicol, endotracheal intubation, ECG monitoring, routine disinfection of sterile towels, puncture of the left carotid artery, and insertion of a 9F sheath.

2. Perform angiography of the left and right iliac arteries, select the implanted blood vessel, and require the diameter of the stent to be 25% larger than the diameter of the blood vessel.

3. Use a pressure pump to suck the balloon of the delivery device into a negative pressure, withdraw the outer sheath tube, curl and wrap the slider stent on the delivery device balloon respectively, and then push the outer sheath tube forward to the cone to enclose the stent . Insert the stent delivery device into the target site along the guide wire, expand and release the stent at 12-15atm*30 seconds. Intraoperative heparin 100U/Kg.

4. Suction the balloon back into negative pressure, withdraw the balloon, and perform angiography again.

2. Observation indicators:

1. Delivery device success rate

Evaluation criteria: successfully delivered to the target site, no stent falling off, and accurate positioning under DSA.

2. Incidence rate of complications: stent displacement, shedding, balloon injury, tearing and blood vessel injury, bleeding from tearing, pig death, etc.

3. Results:

The delivery device can deliver the stent to the target site without displacement or falling off. The delivery device can be precisely positioned and released under X-ray, the stent is successfully expanded, and the stent blood vessel is unblocked. There were no complications such as balloon injury or vascular injury.

Table 3: Results of PCL edge-slider stent delivered by delivery device

Example 4

In the experimental porcine iliac artery, a new type of sliding buckle stent delivery device was used to deliver the polydioxanone (PDO) edge sliding buckle stent, and the delivery and release of the stent were observed.

1. Materials and methods

Materials: 10 25Kg pigs, puncture needle, guide wire, 7F sheath, Omnipaque, chloramphene, heparin, stent delivery device, pressure pump and GE-2005 angiography apparatus.

Sample content: 10 pigs, 15 PDO sliding buckle brackets 20*8mm.

Specific steps and methods: (see Figure 6, 7, 8)

1. Pigs were anesthetized with 10 mg/Kg of chloramphenicol, endotracheal intubation, ECG monitoring, routine disinfection of sterile towels, puncture of the left carotid artery, and insertion of a 9F sheath.

2. Perform angiography of the left and right iliac arteries, select the implanted blood vessel, and require the diameter of the stent to be 25% larger than the diameter of the blood vessel.

3. Use a pressure pump to suck the balloon of the delivery device into a negative pressure, withdraw the outer sheath tube, curl and wrap the slider stent on the delivery device balloon respectively, and then push the outer sheath tube forward to the cone to enclose the stent . Insert the stent delivery device into the target site along the guide wire, expand and release the stent at 12-15atm*30 seconds. Intraoperative heparin 100U/Kg.

4. Suction the balloon back into negative pressure, withdraw the balloon, and perform angiography again.

2. Observation indicators:

1. Delivery device success rate

Evaluation criteria: successfully delivered to the target site, no stent falling off, and accurate positioning under DSA.

2. Incidence rate of complications: stent displacement, shedding, balloon injury, tearing and blood vessel injury, bleeding from tearing, pig death, etc.

3. Results:

The delivery device can deliver the stent to the target site without displacement or falling off. The delivery device can be accurately positioned and released under X-ray, the stent is successfully expanded, and the stent blood vessel is unblocked. There were no complications such as balloon injury or vascular injury.

Table 4: Example results of PDO edge slider stent delivered by delivery device

Fig. 6 shows an angiographic image of the stent being delivered to the pig's left common iliac artery using the delivery device of the present invention, and after being accurately positioned according to the marks at both ends of the balloon, the overtube is withdrawn to the proximal end of the balloon catheter. Fig. 7 shows the contrast images of the balloon-releasing stent pressurized by the pressure pump. Fig. 8 shows an angiogram showing that after the stent is released, the delivery device is withdrawn, the blood vessel is supported by the stent, and the stent blood vessel remains unobstructed.

Reference herein to patents, patent applications, publications and documents is not an admission that any of said documents is prior art, nor is it an admission as to the contents or date of these publications or documents.

Modifications may be made to the above without departing from the essential aspects of the invention. Although the substantive details of the present invention have been described with reference to one or more specific embodiments, those of ordinary skill in the art will know that changes can be made to these specific embodiments disclosed in the application, and these improvements and enhancements still belong to the scope and scope of the present invention. idea. The invention illustratively described herein may be practiced in the absence of one or more of the elements specifically disclosed herein. Thus, for example, in each example of the present invention, any of the terms "comprising", "consisting essentially of" and "consisting of" can be used in the other two terms any alternative of . Accordingly, the terms and expressions used are terms of description and not of limitation, not excluding equivalents of features shown and described or portions thereof, it being understood that various modifications are possible within the scope of the invention.

Claims (8)

1. one kind is delivered to the delivery apparatus of narrow tube chamber with laminar slide fastener biological support, and described device comprises:

Trocar sheath, it has the inner chamber that extends between a near-end, a far-end and two ends;

Interior sheath pipe, it has the inner chamber that extends between a near-end, a far-end and two ends, and the external diameter of described interior sheath pipe is suitable for being slidably inserted in the tube chamber of described trocar sheath; With

Foley's tube, it has the inner chamber that extends between a near-end, a far-end and two ends, the external diameter of described foley's tube is suitable for being slidably inserted in the tube chamber of described interior sheath pipe, the far-end of foley's tube has sacculus, laminar integrated slide fastener support can be arranged on the described sacculus, in catheter delivery arrives narrow tube chamber.

2. delivery apparatus as claimed in claim 1 is characterized in that, described laminar integrated slide fastener support comprises:

Flat rack body, described rack body has mesh-structured;

Be positioned at the support head of described rack body one end, described support head and rack body are integrally formed, and its size adapts with described rack body, and described support head plays the slide fastener effect in the curly course of described support; With

The support button, described support button is also integrally formed with described rack body, is used at the curly course of described support support being fixed into piped support button.

3. delivery apparatus as claimed in claim 1 is characterized in that, but shorter slightly than described foley's tube, described interior sheath pipe can extend to the balloon proximal of foley's tube to described interior sheath pipe always, can prevent that like this support from sliding to near-end than described overcoat pipe range.

4. delivery apparatus as claimed in claim 1 is characterized in that, with a cone, can prevent that support from sliding to far-end on the far-end of described sacculus.

5. delivery apparatus as claimed in claim 4 is characterized in that, described cone proximal part can insert among the described trocar sheath, makes the outer surface of cone and trocar sheath keep same level.

6. delivery apparatus as claimed in claim 1 is characterized in that, respectively there is a metal marker thing at described sacculus two ends, can help the support location.

7. delivery apparatus as claimed in claim 1 is characterized in that, described device also comprises two Y type adapters, and one of them Y type adapter is placed in interior sheath pipe near-end, is communicated with its inner chamber; Another Y type adapter is placed in the trocar sheath near-end, is communicated with its inner chamber.

8. rig, it comprises:

Stent delivery device as claimed in claim 1; With

Laminar integrated slide fastener biological support, described support comprises:

Flat rack body, described rack body has mesh-structured;

Be positioned at the support head of described rack body one end, described support head and rack body are integrally formed, and its size adapts with described rack body, and described support head plays the slide fastener effect in the curly course of described support; With

The support button, described support button is also integrally formed with described rack body, is used at the curly course of described support support being fixed into piped support button.

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