WO2012088888A1

WO2012088888A1 - Transporting and releasing device for medical intervention instruments

Info

Publication number: WO2012088888A1
Application number: PCT/CN2011/078271
Authority: WO
Inventors: 谢志永; 刘亚杰; 赵振心; 朱佳英; 王森; 金巧蓉; 罗七一
Original assignee: 微创医疗器械(上海)有限公司
Priority date: 2010-12-31
Filing date: 2011-08-11
Publication date: 2012-07-05
Also published as: CN102525698A

Abstract

Disclosed in the present application is a transporting and releasing device for medical intervention instruments, which includes an outer sheath pipe, a middle pipe and an inner pipe, wherein the inner pipe, the middle pipe and the outer sheath pipe are successively distributed from inside to outside; a through hole is provided on the wall of the outer sheath pipe, a slot is provided on the middle pipe, and a side pipe is provided on the inner pipe, with the side pipe passing through the slot on the middle pipe and being fixed to the through hole on the outer sheath pipe and the side pipe communicating with the through hole. During the use of the transporting and releasing device for medical intervention instruments, after a guide wire enters from a distal end of the inner pipe, the guide wire can not only pass through and exit from the proximal end of the inner pipe but also pass through and exit from the side pipe. Therefore, it not only has the advantages of coaxial transporting and releasing devices, but also has the advantages of fast switch transporting and releasing devices, and it can be switched over quickly between these two modes according to the requirements of the actual situation, which saves surgery time and improves the surgery success rate at the same time.

Description

Interventional medical device delivery and release device

The present application relates to the field of medical device technology, and in particular to an interventional medical device delivery and release device. Background technique

Interventional medical devices are emerging medical device technologies in recent years, which play an important role in reducing trauma to patients and improving the therapeutic effect of diseases. For example: Interventional devices used in various lumens of the human body, such as vascular stents, biliary stents, esophageal stents, intestinal stents, pancreatic duct stents, urethral stents or tracheal stents. Among them, stents are particularly prominent in the field of interventional medical devices. At the time of surgery, the stent is delivered to the obstructed lesion of the blood vessel through the delivery and release device, and then the stent is released, and the stent is expanded by the stent to expand the blocked vessel to keep the blocked vessel open.

At present, the stent delivery and release device has two main structures: a coaxial delivery and release device and a rapid exchange delivery and release device, wherein: the guide wire lumen in the coaxial delivery and release device runs through the entire device, when in use The guide wire is penetrated by the distal end and is pierced by the proximal end. The coaxial delivery and release device has a strong ability to pass through the vascular lesion site, but it is inconvenient to use, and often requires a length of 3 meters of extended guide wire and often requires 2-3 operators can complete the operation; while the guidewire lumen in the quick-swive delivery and delivery device is short, the guidewire lumen is typically about 20-40 cm long from the tip end and is open from the side wall of the delivery and release device When in use, the guide wire is inserted through the head end and is pierced by the opening on the side wall. It only takes 2 meters of guide wire to be operated by a single person, but its ability to pass through the vascular lesion is slightly poor, which may easily lead to surgical failure. .

By studying the prior art, the applicant found that: If there are several obstructed lesions in the patient's blood vessel, if the coaxial delivery and release device is used alone, the operation is cumbersome and time consuming; The delivery and release device, while operating the cartridge, increases the probability of surgical failure. There is therefore a need for a device that can unify the two stent delivery and delivery devices. Summary of the invention

In view of this, the embodiments of the present application provide an interventional medical device delivery and release device, and a side tube is disposed between the inner tube wall and the outer sheath tube wall to realize the coaxial conveying and releasing device and the quick exchange conveying Combined with the release device, it can also be switched between the two forms during use, saving operation time and improving the success rate of the operation.

In order to achieve the above objectives, the technical solutions provided by the embodiments of the present application are as follows:

An interventional medical device delivery and release device, comprising: an outer sheath tube, a middle tube and an inner tube, wherein: the inner tube, the middle tube and the outer sheath tube are sequentially distributed from the inside to the outside;

The outer sheath tube wall is provided with a through hole, the middle tube is provided with a groove, the inner tube is provided with a side tube, and the side tube passes through the groove on the middle tube and the outer sheath tube The upper through holes are connected and fixed, and the side tubes are in communication with the through holes.

Preferably, the distal end of the inner tube is located inside the outer sheath tube, and the distal end of the inner tube extends out of the outer sheath tube.

Preferably, the distance of the through hole from the distal end of the outer sheath tube is between 100 mm and 500 mm.

Preferably, the apparatus further comprises: a village core located in the inner tube, and a distal end of the village core is located at an inner opening of the inner tube.

Preferably, the head end of the village core has a wedge-shaped structure, and the slope of the slope of the wedge structure is equal to the angle between the side tube axis and the inner tube axis.

Preferably, the apparatus further comprises: a top ring located at a distal end of the middle tube.

Preferably, the apparatus further comprises: a head end fixed at a position where the inner tube protrudes from the outer sheath tube, and a gap is provided between the outer sheath tube and the outer sheath tube.

Preferably, the apparatus further comprises: a booster rod secured to the proximal end of the middle tube.

Preferably, the end of the boosting rod is provided with a handle, and the end of the handle is provided with a locking device for locking the village core and the boosting rod.

Preferably, the apparatus further comprises: a Y-valve, the Y-valve being coupled to the sheath via a connector and having a proximal end that is lockable and sealable with the booster.

Preferably, the outer sheath tube is a polymer material tube or a braided wire reinforcing tube.

Preferably, the material of the middle tube, the inner tube and the side tube is a polymer material.

Preferably, the material of the village core is a metal or a polymer material. Preferably, the polymer material comprises one or more of a polyether-amino block copolymer resin, a nylon resin, a polyimide resin, a polyurethane, a polytetrafluoroethylene, and a polyetheretherketone.

Preferably, the metal material comprises stainless steel, nickel titanium alloy or titanium alloy. It can be seen from the above technical solution that in the interventional medical device delivery and release device provided by the application embodiment, a long groove is disposed on the middle tube, a side tube is disposed between the outer sheath tube and the inner tube, and the side tube passes through The long groove on the tube, that is, the outer sheath tube and the inner tube are fixed together, and the outer sheath tube and the inner tube can move back and forth with respect to the middle tube. When the interventional medical device delivery and release device is in use, the guide wire can be passed through not only the proximal end of the inner tube but also the side tube when the guide wire enters the distal end of the inner tube. When the guide wire is passed out from the proximal end of the inner tube, the guide wire and the inner tube are coaxially distributed, so that the interventional medical device delivery and release device has a strong crossing ability; when the guide wire is from the side tube When worn out, the interventional medical device delivery and delivery device is only slightly worn over the guidewire with less resistance, allowing the interventional medical device delivery and release device to rapidly advance along the guidewire.

Therefore, the interventional medical device delivery and release device provided by the embodiment of the present application not only has the advantages of a coaxial delivery and release device, but also has the advantages of a fast exchange delivery and release device, and can also be quickly used according to actual needs. Switching between the two forms saves surgery time and increases the success rate of surgery.

DRAWINGS

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings to be used in the embodiments or the description of the prior art will be briefly described below. Obviously, the drawings in the following description It is only some of the embodiments described in the present application, and other drawings can be obtained from those skilled in the art without any creative work.

1 is a partial cross-sectional structural view of an interventional medical device delivery and release device according to Embodiment 1 of the present application;

2 is a schematic view showing the use of an interventional medical device delivery and release device according to Embodiment 1 of the present application;

3 is a partial portion of an interventional medical device delivery and release device according to a second embodiment of the present application; Schematic diagram of the cross-sectional structure;

4 is a partial cross-sectional structural view of an interventional medical device delivery and release device according to a third embodiment of the present application.

detailed description

The technical solutions in the embodiments of the present application are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present application. The embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments of the present application, without departing from the inventive work, should fall within the scope of the present application. Embodiment 1:

1 is a partial cross-sectional structural view of an interventional medical device delivery and release device according to Embodiment 1 of the present application.

As shown in FIG. 1, the interventional instrument delivery and release device comprises: an outer sheath tube 1, a middle tube 2 and an inner tube 3, wherein: the inner tube 3, the middle tube 2 and the outer sheath tube 1 are sequentially arranged from the inside to the outside, and The inner tube 3, the middle tube 2 and the outer sheath tube 1 are movable relative to each other, a long groove 6 is arranged on the middle tube, and a side tube 5 is provided between the wall of the outer sheath tube 1 and the wall of the inner tube 3, and the side tube 5 Through the long groove 6, the top ring 4 is fixed to the distal end of the middle tube 2.

A through hole 101 is disposed in the wall of the outer sheath tube 1. In the embodiment of the present application, the position of the through hole 101 is preferably disposed at a distance of 100 mm to 500 mm from the distal end of the outer sheath tube 1. The middle tube 2 is located inside the outer sheath tube 1, the outer diameter of which is smaller than the inner diameter of the outer sheath tube 1, and the distal end of the middle tube 2 is located inside the outer sheath tube 1, that is, between the distal end of the outer sheath tube 1 and the distal end of the middle tube 2 A reserved position is provided, and a long groove 6 conforming to the axial direction is provided on the middle tube 2, and the length of the long groove 6 is greater than the length between the distal end of the outer sheath tube 1 and the distal end of the middle tube 2.

The inner tube 3 is located inside the middle tube 2, the outer diameter of which is smaller than the inner diameter of the middle tube 2, and the distal end of the inner tube 3 is located outside the outer sheath tube 1. A side tube 5 is disposed on the inner tube 3, and the side tube 5 is fixed through the long groove 6 on the middle tube 2 and the through hole connection on the outer sheath tube 1, and the inside of the inner tube 3 is connected to the outside of the outer sheath tube 1. . In addition, the distance between the inner opening of the side tube 5 and the distal end of the outer sheath tube 1 is smaller than the outer opening of the inner tube 5 (ie, the through hole 101) The distance from the distal end of the sheath tube 1, i.e., the direction of extension of the side tube 5 from the inner opening to the outer opening, toward the proximal end of the interventional instrument delivery and release device.

In the embodiment of the present application, as shown in FIG. 1, in order to increase the distal cross-sectional area of the middle tube 2, a top ring 4 may be disposed at the distal end of the middle tube 2, and the inner diameter of the top ring 4 is larger than the inner tube 3. The outer diameter of the outer diameter is smaller than the inner diameter of the outer sheath tube 1. The use of the top ring 4 allows the interventional medical device to be more stably secured in the reserved position and more convenient to push the interventional medical device out of the outer sheath when released.

In addition, in the embodiment of the present application, the outer sheath tube 1, the middle tube 2, the inner tube 3, and the side tube 5 may be made of a polymer material tube, and the polymer material includes a polyether-amino block copolymer resin, a nylon resin, and a poly One or more of an imide resin, a polyurethane, a polytetrafluoroethylene, a polyetheretherketone or the like. After the use of high molecular materials, the interventional medical device delivery and release device has a certain elasticity and can be bent, and also has a certain strength, can move within the blood vessels of the human body without causing damage to the blood vessels. In addition, the outer sheath tube 1 can also be a braided wire reinforcing tube as needed. The braided wire reinforcing tube generally consists of three layers, including: an inner layer, an outer layer and a woven mesh reinforcing layer, wherein: and the inner and outer layers of material pass through The woven mesh reinforcement layer is tightly wrapped with the woven mesh reinforcement layer, and the inner layer and the outer layer are both polymer materials. The woven wire of the woven mesh reinforcing layer may be a metal wire or a high modulus low shrink type fiber filament, and the fiber filament may include a polyester filament, a polypropylene filament, a nylon filament, a nylon, a carbon fiber or the like.

In the embodiment of the present application, the interventional medical device refers to a stent that is well known to those skilled in the art and applied to various lumens of the human body, including but not limited to a biliary stent, an esophageal stent, an intestinal stent, a pancreatic stent, Urethral stent or tracheal stent. Before using the interventional medical device delivery and release device provided by the embodiment of the present application for delivery, the stent 7 needs to be compressed and placed at a reserved position between the distal end of the outer sheath tube 1 and the distal end of the middle tube 2, and the stent 7 is itself The elastic is closely attached to the inner wall of the outer sheath tube 1, as shown in Fig. 2, the compressed stent is 7.

During delivery, the guide wire 8 is first inserted into the diseased blood vessel, and then the distal end of the inner tube 3 is inserted through the distal end of the guide wire 8, and then the degree of difficulty in the passage of the lesion in the blood vessel is selected according to the need. The position of the guide wire 8 is taken out. When the lesion in the blood vessel is difficult to pass through, the guide wire is selected to pass through the end of the inner tube 3, and the guide wire 8 and the inner tube 3 are coaxially distributed, so the interventional medical device is transported and The release device can easily pass through a lesion in the blood vessel that is difficult to pass through. When the lesion in the blood vessel is less difficult to pass through, the guide wire 8 is pierced from the side tube 5, and the intervention is performed. The medical device delivery and delivery device passes through the guide wire 8 for a shorter length and less resistance so that it can pass through the blood vessel quickly.

In addition, in actual clinical operation, the operator can also first pass the guide wire 8 out of the side tube 5, and when encountering a lesion that cannot be passed, the device is then withdrawn from the human body, and then the guide wire 8 is taken from the inside. The proximal end of the tube 3 is pierced. That is, the operator can quickly adjust the position of the guide wire 8 according to actual needs, and switch between the coaxial type and the fast exchange type to save the operation time.

Finally, when the stent 7 is transported into position, the middle tube 2 is first fixed, and then the outer sheath tube 1 is brought back together with the inner tube 2 and the side tube 5 to 3⁄4. Since the bracket 7 is in close contact with the inner wall of the outer sheath tube 1 by its own elasticity, when the outer sheath tube 1 is withdrawn backward, the bracket 7 will be retracted together, and the top ring 4 fixed at the distal end of the middle tube 2 will The stent 7 is ejected from the reserved position to the outer sheath tube 1. At the time of release, it is possible to accurately and uniformly release the stent 7 into the human body lumen or blood vessel by appropriately controlling the speed of the outer sheath 1 of the outer sheath 1. Embodiment 2:

In the embodiment of the present application, when the guide wire 8 needs to be passed out from the side tube 5, in order to make the guide wire 8 easier to pass through the side tube 5, the interventional medical device delivery and release device may further include a village core. 9.

As shown in FIG. 3, a partial cross-sectional structural view of an interventional medical device delivery and release device according to Embodiment 2 of the present application is shown. In the figure, the village core 9 is located at the proximal end of the side tube 5 and the proximal end of the inner tube 3. The diameter is smaller than the inner diameter of the inner tube 3. When it is necessary to pass the guide wire 8 out of the side tube 5, the village core 9 is inserted into the inner cavity from the proximal end of the inner tube 3, and the front end thereof reaches the inner opening of the side tube 5, so that the guide wire 8 is inside. When the distal end of the tube 3 penetrates into the position of the opening in the side tube 5, the core 9 can cause the guide wire 8 to enter the side tube, as shown in FIG. In the embodiment of the present application, in order to facilitate the passage of the guide wire 8 from the side tube 5, the front end of the village core 9 is preferably a wedge-shaped structure, and the slope of the slope of the wedge-shaped structure is preferably the axis of the side tube 5 and the axis of the inner tube 3. The angle between them is the same. In addition, the material of the core 9 is the same as that of the outer sheath 1, the middle tube 2 or the inner tube 3, so that the village core 9 can be bent together with the interventional medical device delivery and release device, and the core 9 The material can also be a wire. Embodiment 3:

4 is a partial portion of an interventional medical device delivery and release device according to a third embodiment of the present application; A schematic cross-sectional view of the structure.

As shown in FIG. 4, the interventional medical device delivery and release device further includes: a head end 10 fixed to an outer wall of the inner tube 3 near the distal end of the outer sheath tube 1, the head end 10 having a larger diameter than the outer sheath tube The outer diameter of 1 and the material of the head end 10 are made of a polymer material, including one or more of polyether-amino block copolymer resin, nylon resin, polyurethane, polytetrafluoroethylene and the like. The purpose of the head end 10 is to avoid damage to the vessel wall as the sheath tube 1 moves along the guidewire 8 during delivery.

As shown in Fig. 4, the interventional medical device delivery and release device further includes: a booster rod 11 fixed to the proximal end of the middle tube 2, and a handle 12 disposed at the end of the booster rod 11. The function of the booster rod 11 is to facilitate the transfer of the operator's force when the outer sheath tube 1 is withdrawn backwards during the release of the stent. Further, a locking device 13 is provided behind the handle 12 for locking the core 9, so that the head end of the core 9 can be fixed at the inner opening of the side tube 5.

As shown in Fig. 4, the interventional medical device delivery and release device further includes: a Y-type valve 14, and a Y-type valve 14 is fixed to the proximal end of the outer sheath tube 1 by a connecting member 15. The end of the Y-valve 14 can be locked and sealed with the booster rod 11 to fix the booster rod 11 to prevent the booster rod 11 from moving before use. In the embodiment of the present application, the distance between the handle 12 and the proximal end of the Y-shaped valve 14 is smaller than the length of the long groove 6 in the middle tube 2, preventing the handle 12 from interfering with the release of the bracket. It can be seen from the above technical solution that in the interventional medical device delivery and release device provided by the application embodiment, a long groove is disposed on the middle tube, a side tube is disposed between the outer sheath tube and the inner tube, and the side tube passes through The long groove on the tube, that is, the outer sheath tube and the inner tube are fixed together, and the middle tube can move back and forth in the outer sheath tube relative to the outer sheath tube and the inner tube. When the interventional medical device delivery and release device is in use, the guide wire can be passed through not only from the proximal end of the inner tube but also from the side tube when the guide wire is advanced from the distal end of the inner tube. When the guide wire is passed out from the proximal end of the inner tube, the guide wire and the inner tube are coaxially distributed, so that the interventional medical device delivery and release device has a strong crossing ability; when the guide wire is from the side tube When worn out, the interventional medical device delivery and delivery device is only slightly worn over the guidewire with less resistance, allowing the interventional medical device delivery and release device to rapidly advance along the guidewire.

Therefore, the interventional medical device delivery and release device provided by the embodiment of the present application not only has the advantages of a coaxial delivery and release device, but also has the advantages of a fast exchange delivery and release device, and can also be quickly used according to actual needs. Switch between the two forms, saving time during surgery At the same time, the success rate of surgery was improved.

The above description is only a preferred embodiment of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments are obvious to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the application. Therefore, the application is not limited to the embodiments shown herein, but the broadest scope consistent with the principles and novel features disclosed herein.

Claims

Claim

What is claimed is: 1. An interventional medical device delivery and release device, comprising: an outer sheath tube, a middle tube and an inner tube, wherein:

The inner tube, the middle tube and the outer sheath tube are sequentially arranged from the inside to the outside;

2. Apparatus according to claim 1 wherein the distal end of said inner tube is located inside said outer sheath tube and the distal end of said inner tube extends beyond said outer sheath tube.

3. The device according to claim 2, wherein the distance of the through hole from the distal end of the outer sheath tube is between 100 mm and 500 mm.

4. The apparatus according to claim 1, further comprising: a top ring located at a distal end of the middle tube.

The apparatus according to claim 1, further comprising: a village core located in said inner tube, and a distal end of said village core being located at an inner opening of said inner tube.

The device according to claim 5, wherein the head end of the village core has a wedge-shaped structure, and a slope of the slope of the wedge-shaped structure is equal to an angle between the side tube axis and the inner tube axis.

7. The device according to claim 1, further comprising: a head end fixed at a position where the inner tube protrudes from the outer sheath tube, and a gap is provided between the outer sheath tube and the outer sheath tube.

8. Apparatus according to claim 1 and further comprising: a booster rod secured to the proximal end of said middle tube.

9. The device according to claims 5 and 8, wherein the end of the booster rod is provided with a handle, and the end of the handle is provided with a locking device for aligning the village core with the booster rod Locked.

10. The apparatus according to claim 8, further comprising: a Y-type valve, said Y-shaped valve being coupled to said outer sheath tube by a connecting member, and wherein said proximal end is engageable with said booster rod Locked and sealed.

The device according to claim 1, wherein the outer sheath tube is a polymer material tube or a braided wire reinforcing tube.

12. The device according to claim 1, wherein the material of the middle tube, the inner tube and the side tube is a polymer material.

13. Apparatus according to claim 5 wherein the material of the village core is a metal or polymeric material.

The device according to claim 11, 12 or 13, wherein the polymer material comprises a polyether-amino block copolymer resin, a nylon resin, a polyimide resin, a polyurethane, and a polytetrafluoroethylene. And one or more of polyetheretherketone.

15. Apparatus according to claim 13 wherein said metallic material comprises stainless steel, nickel titanium alloy or titanium alloy.