CN210541686U

CN210541686U - Plugging catheter for treating coronary artery perforation

Info

Publication number: CN210541686U
Application number: CN201822134583.3U
Authority: CN
Inventors: 张晓霞; 赵全明; 田磊; 陈青; 汪国忠; 张晓江
Original assignee: Beijing Anzhen Hospital
Current assignee: Beijing Anzhen Hospital
Priority date: 2018-12-19
Filing date: 2018-12-19
Publication date: 2020-05-19
Anticipated expiration: 2028-12-19

Abstract

The utility model provides a shutoff pipe for treating coronary artery is fenestrate, the shutoff pipe is including the pipe that has the seal wire chamber and its inside shutoff membrane that links to each other with control handle through two seal wires. The guide wire cavity extends forwards at the head end of the plugging catheter to form a top end, so that the plugging catheter can pass through the blood vessel conveniently. The occlusion catheter significantly improves the occlusion efficiency and also significantly reduces the possibility of hemodynamic deterioration during waiting for stent graft.

Description

Plugging catheter for treating coronary artery perforation

Technical Field

The utility model belongs to the technical field of medical instrument, in particular to a shutoff pipe for treating coronary artery is fenestrate.

Background

Coronary perforation is a serious complication in coronary intervention, and once it occurs, pericardial tamponade occurs quickly, endangering the life of the patient. With the wide development of interventional therapy and the increase of interventions on chronic occlusive lesions and calcific tortuous lesions, the interventional therapy gradually becomes an important problem which puzzles interventional doctors and threatens the life and health of patients with coronary heart disease.

Once coronary perforation has occurred, the first approach taken in the prior art was to occlude with a balloon, see for example "MTI occlusion balloon catheter and system" published by encyclopedic 2013, 11, 17, linked specifically to https:// baike.baidu.com/item/MTI occlusion balloon catheter and system/15642918? fr ═ aladdin. If the diameter of the selected saccule is small, the effect of plugging is difficult to achieve, and the diameter of the saccule is large, so that the wall of the blood vessel is pulled, and the thrombus formation at the position of the broken opening is not facilitated. In general, occlusion is difficult to achieve and is often a transitional measure while waiting for a stent graft. Even if the plugging is successful, the occlusion of blood vessels can be caused, myocardial infarction of corresponding blood supply areas can be caused, and the heart function of a patient can be seriously influenced.

The current effective treatment for coronary perforation is the implantation of a stent graft, see in particular the link https:// image. the link between the stent graft and its target site is named "baidumage & ct" ("201326592 & lm") -1& cl "(" 2& ie "(" gb18030& word "(" B8% ") 2% (" C4% ") 4% (" D6% ") 7% (" BC% ") DC & fr" ("ala & ala" ("1 & altpl" ("ad ress & pos) (" 0& hs "(" 2& xthttps) ("111111). However, stents are very expensive, are not always available in a catheter room, may die due to hemodynamic deterioration while waiting, or are not generally affordable for the patient. Even if a stent graft is available at a suitable price and diameter, the stent graft may be difficult or fail to implant due to its rigidity and poor passability. Further, even if the stent graft is successfully implanted, the risk of thrombus and restenosis within the stent is significantly increased due to the wall thickness of the stent graft.

Therefore, there is a need for an occlusion catheter having properties suitable for treating coronary artery fenestrations.

SUMMERY OF THE UTILITY MODEL

In order to overcome the poor regulation ability and the bad scheduling problem of safety and stability of prior art, the utility model provides a shutoff pipe for treating coronary artery is fenestrate. The blocking efficiency is obviously improved, and the possibility of hemodynamic deterioration in the process of waiting for the covered stent is also obviously reduced.

According to the technical scheme of the utility model, a plugging catheter for treating coronary perforation is provided, which comprises a catheter with a guide wire cavity and a plugging membrane, wherein the interior of the catheter is connected with a control handle through two guide wires; the occlusion catheter is divided into a head end part, a distal end part and a proximal end part; the proximal portion is adjacent to the operating handle, and the distal portion is connected at one end to the proximal portion and at the other end to the head portion.

Preferably, the head portion, the distal portion and the extension of the distal portion to the proximal portion of the occlusion catheter are arranged inside a through-going guidewire lumen parallel to the catheter lumen. The plugging catheter is provided with a lumen for accommodating the plugging membrane and the control guide wire thereof, and a protective sheath is arranged between the tail end of the lumen and the control handle.

More preferably, the head end portion of the occlusion catheter is provided with a flap device. The plugging film is composed of a rhomboid or oval memory metal wire frame and a polyurethane film fixed on the memory metal wire frame. The plugging film metal wire frame is connected with the control handle through the control guide wire. A branch catheter is arranged at the position, close to the operating handle, of the plugging catheter and is communicated with the main catheter through a side hole.

Now to prior art, use the utility model provides a shutoff pipe has obviously improved shutoff efficiency, also is showing the reduction and appearing the possibility that the hemodynamics worsened waiting for tectorial membrane support in-process. Compared with other catheters for treating coronary perforation, the plugging bracket of the utility model can be applied to any complications of vascular perforation because the plugging bracket is not limited by the model. A small inventory in the catheter lab is effective in preventing malignant complications.

Drawings

Fig. 1 shows a schematic structural view of an occlusion catheter for treating coronary artery perforation according to the present invention.

Fig. 2 is an enlarged schematic view of a longitudinal section of the occlusion catheter of fig. 1.

Fig. 3 is an enlarged schematic view of a cross-section of the distal portion of the catheter of fig. 1.

Fig. 4 is an enlarged schematic view of a portion of the cross-section of the catheter tip a or a' of fig. 1.

Fig. 5 is a schematic structural view of another embodiment of an occlusion catheter provided by the present invention.

Fig. 6 is a schematic structural view of the blocking catheter according to the present invention when releasing the blocking membrane after reaching the working position.

Figure 7 is an enlarged schematic view of the occluding membrane being released from the tip portion of the catheter tip wherein the occluding membrane is in the shape of a rounded diamond.

Figure 8 is an enlarged schematic view of another embodiment of the occluding membrane released out of the tip portion of the catheter tip wherein the occluding membrane is oval in shape.

Fig. 9 is a schematic cross-sectional view of an occluding membrane occluding a perforated vessel.

Fig. 10 is a schematic long-axis cross-sectional view of an occluding membrane occluding a perforated vessel.

The reference symbols shown in the drawings are:

1-plugging the head end part of the catheter; 2-a catheter distal portion; 3-catheter proximal section; 4-guide wire cavity; 5-top end; 6 a protective sheath; 7-operating handle; 8-branch conduit, 9-plugging membrane; 10-gelatin sponge particles adhered to the occlusion membrane; 11-wire frame of the occluding membrane; b, b' -the two free ends of the wire framework; 12, 12 "-two steering wires of the occlusion membrane, 13-the catheter lumen; 14-ring-shaped steel wire; 15-a flap; 16-parallel wires, 17-removable fixation clips, 18-vessel walls; 19-a perforation site; 20 — an inflated balloon; 21-balloon shaft.

The specific implementation mode is as follows:

the technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It is obvious that the described embodiments are only some of the embodiments of the present invention, and not all of them. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention. In addition, the scope of the present invention should not be limited to the particular structures or components or the specific parameters described below.

The utility model provides a plugging catheter for treating coronary perforation, which comprises a catheter with a guide wire cavity and a plugging film, wherein the interior of the catheter is connected with a control handle through two guide wires; the occlusion catheter is divided into a head end part, a distal end part and a proximal end part; the head end part, the distal end part and the transition section from the distal end part to the proximal end part are provided with guide wire cavities so as to facilitate the occlusion catheter to enter the body in a rapid exchange mode; the guide wire cavity extends forwards from the head end of the plugging catheter to the far end to form a top end, so that the plugging catheter can pass through the blood vessel conveniently.

Preferably, the occlusion catheter is provided with a lumen for accommodating the occlusion membrane and a control guide wire thereof, and a protective sheath is arranged between the tail end of the lumen and the control handle so as to prevent the occlusion membrane from being released when the occlusion membrane does not reach the working position. The head end of the catheter is provided with a valve device to prevent blood from entering the catheter after the catheter enters the body. The plugging film is composed of a rhomboid or oval memory metal wire frame and a polyurethane film fixed on the memory metal wire frame.

In addition, a layer of gelatin sponge particles is adhered on the polyurethane film, and can absorb water in blood to expand after being released. And is closely attached to the rupture port of the blood vessel under the assistance of other devices such as an expanded balloon so as to play a role in blocking and stopping bleeding. The plugging membrane wire frame is connected with the control handle through the control guide wire, and after the catheter reaches the working position, the protective sheath can be removed, and the handle is pushed to release the plugging membrane. The angle of the plane of the occlusion membrane can be controlled to be parallel to the vessel wall by rotating the handle. The catheter part near the handle can be provided with a branch catheter which is communicated with the main catheter through a side hole and can be injected with normal saline to be beneficial to lubrication.

When the plugging catheter for treating coronary perforation of the utility model is used, the plugging process is repeated for a plurality of times within 5-10 minutes until the plugging is successful. The occlusion interval releases the inflated balloon to open the vascular blood supply.

Compared with the prior art, the plugging catheter for treating coronary perforation of the utility model has obvious technical advantages. For example, in the research process, a covered stent manufactured by using a medical 3M patch is implanted into a patient, although the perforation can be processed in time, the 3M patch is introduced into the patient, and the 3M patch does not have biocompatibility and toxicology test data for long-term implantation in the body, and the possibility that other risks exist, such as whether the endothelialization of the stent is influenced, whether the risk of thrombus or restenosis is obviously increased, and the like.

The technical solution of the present invention will be described in detail with reference to the accompanying drawings.

Example 1 the present invention provides an occlusion catheter for use in the treatment of coronary perforation. Referring to fig. 1 to 4, the occlusion catheter for treating coronary perforation includes a catheter and an occlusion membrane connected to a control handle through two control guide wires in a lumen of the catheter, the catheter has a hollow cavity structure, i.e. a catheter lumen, the two control guide wires pass through the catheter lumen, the control guide wires are connected to a wire frame of the occlusion membrane through free ends of the wire frame, and sponge particles, preferably gelatin sponge particles, are adhered to the wire frame; the two control guide wires are connected with the control handle. The end of the metal wire frame is connected with a plugging film. As shown in fig. 4, a guide wire lumen 4 through which a guide wire passes is provided outside the catheter lumen.

The plugging catheter is provided with a head end part 1, a distal end part 2 and a proximal end part 3, wherein the proximal end part 3 is close to an operating handle 7, one end of the distal end part 2 is connected with the proximal end part 3, the other end of the distal end part 2 is connected with the head end part 1, the wall of the plugging catheter is of a three-layer structure, and the three-layer structure is respectively an inner layer and an outer layer which are made of medical polymer materials and a middle layer which is woven by steel. The purpose of the intermediate layer is to enhance the pushing force of the catheter to facilitate passage through the guiding catheter and the vessel lumen to the working position. The design of each section of conduit is different due to different functions.

The proximal section 3 has a length of 500-2000mm, preferably 1300 mm. The proximal part 3 is woven by steel wires, preferably high-density woven medical steel wires, so as to ensure the pushing force; the outer diameter, the inner diameter and the wall thickness adopt the sizes suitable for pushing. After many studies, the proximal portion 3 has an outer diameter of 0.95mm, an inner diameter of 0.65mm, and a catheter wall thickness of 0.15mm is particularly preferred. 0.95mm outside diameter to ensure smooth matching with a 0.6mm balloon rod, and can simultaneously guide the inner cavity of the catheter (1.75mm) through 6F. The inner layer and the outer layer of the proximal part are made of medical high polymer materials. The proximal section 3 is fitted with a branch catheter 8 at its end near the operating handle 7 and is connected to the operating handle 7 via a protective sheath 6.

The distal portion 2 is a flexible braided portion with a length of 100-200mm, preferably 160mm, of braided steel wires, which is thinner than the proximal portion, preferably with a braiding density of 2:1, i.e. the distal portion 2 has a steel wire braiding density half that of the proximal portion, to improve the flexibility of the distal portion. Further, the wall thickness of the catheter of the distal section is reduced to 0.13-0.05mm, preferably 0.1 mm; the reduction in the outer diameter is 0.92 to 0.05mm, preferably 0.9 mm. This design allows the distal portion of the catheter to more easily pass through a tortuous blood vessel. At the same time, the design enables the inner diameter of the distal part of the catheter to be increased, preferably 0.7mm, and facilitates the operation of the guide wire in the catheter when the catheter is bent after passing through the blood vessel. The inner and outer polymer materials of the distal portion are the same as the proximal portion.

The head end part 1 is 5-15mm long, preferably 10mm long; the diameter increases by 0.8-2mm, preferably 1.1 mm. The joint between the head end portion 1 and the distal end portion 2 is a proximal starting end a 'of the head end portion 1, i.e. a distal end point a' of the distal end portion 2. The distal end of the tip portion 1 is the terminal end a of the occlusion catheter. Soft valves made of high polymer materials such as polyurethane or polyethylene are arranged at the positions a' and a, and the valve at the position a is used for preventing blood from entering after the catheter enters a blood vessel. a' is a flap to prevent ingress of saline in the distal portion of the catheter. and the positions a and a 'are both provided with annular steel wires, and the annular steel wire at the position a' is the terminal point of the weaving structure of the middle layer steel wire at the distal part 2. The steel wire of the middle layer of the head end part is three to eight parallel steel wires, preferably six parallel steel wires. The front end of the tip portion 1 has a tip 5 with a length of 1mm to 4mm, preferably 1.5mm, which is an extension of the guidewire lumen 4. The tip 5 is provided to facilitate the intravascular passage of the catheter along the guidewire to the proper working position.

The inner layer and the outer layer of the head end part 1 are preferably made of elastic polyurethane materials, and the design of parallel steel wires of the middle layer is combined, so that the tube cavity deformation of the head end part is facilitated, and the plugging film can still be successfully retracted into the catheter cavity after absorbing the moisture expansion in blood. The tip portion 1, the distal portion 2 and the extension from the distal portion to the proximal portion of the occlusion catheter are arranged inside a continuous guide wire lumen 4 parallel to the catheter lumen to facilitate the catheter to enter the body in a rapid exchange manner. The length of the guide wire cavity 4 is 100-400mm, preferably 220mm, and is matched with the catheter cavity.

As shown in fig. 2, the occlusion membrane 9 is fixed to the wire framework 11, and when the working position is not reached, the occlusion membrane 9 and its wire framework are folded and positioned in the head end portion 1 of the catheter.

The plugging membrane is preferably a polyurethane film and is oval or rhomboid. The widest point is preferably 3 mm. The major diameter is preferably 6 mm. A layer of gelatin sponge particles 10 is uniformly adhered on the surface. The thickness of the occlusion membrane after expansion by absorbing blood moisture is preferably not more than 200um, so that the maximum cross-sectional area after expansion of the occlusion membrane is preferably 0.6mm²Much smaller than the cross-sectional area of the catheter tip portion (preferably 0.95 mm)²) So as to ensure that the plugging membrane is smoothly withdrawn into the head end part of the catheter after plugging is finished. The metal wire frame 11 is made of nickel-titanium alloy with memory function and super-elasticity. The two free ends b and b 'are connected to two steering wires 12 and 12', respectively. The proximal free ends of the two control guide wires are respectively fixed on a control handle 7.

The control guide wire is a stainless steel guide wire, preferably with the diameter of 0.010inch (0.0254mm), and is coated with Polytetrafluoroethylene (PTFE) so as to minimize friction with the wall layer of the catheter and facilitate pushing.

The near-end catheter is provided with a branch catheter 8 at the position near the handle, is communicated with the main catheter through a side hole, and can be injected with saline water to facilitate lubrication. The side hole is located at one side of the proximal catheter, and is preferably in an oval shape of 0.5mm × 1mm, and correspondingly, the branch catheter is in an oval column shape, and the material of the side hole can be medical polymer material well known to those skilled in the art. A protective sheath 6 is provided between the proximal part of the occlusion catheter and the steering handle 7 to prevent the occlusion membrane from being released short of the operating position.

Fig. 5 shows another embodiment of the invention, wherein the protective sheath 6 can be replaced by a removable clip 17.

Figure 6 shows the situation where the protective sheath is removed and the steering handle pushes the occlusion membrane out of the catheter tip portion after the catheter has reached the working position. Figure 7 shows the occlusion membrane returning to its original near diamond shape after release, when the handle is turned to manipulate the angle of the plane of the occlusion membrane to make it parallel to the vessel wall.

Fig. 8 is another embodiment of an occluding membrane. Among them, the plugging membrane is preferably an elliptical shape. Preferably, the tip and distal portion of the occlusion catheter of the present invention are coated with a hydrophilic coating to enhance their passage through the blood vessel.

As shown in fig. 9 and 10, which show a situation where the vessel rupture opening is being occluded with an occlusion membrane from a cross-sectional and a longitudinal cut of the vessel, respectively. As shown in the cross-sectional view of fig. 9, a perforated portion 19 appears on the vessel wall 18, and the gelatin sponge particles 10 attached to the occluding film are closely attached to the blood vessel rupture opening (perforated portion) 19 by the inflated balloon 20. As shown in fig. 10, a perforated part 19 appears on the blood vessel wall 18, the gelatin sponge particles 10 attached to the occlusion membrane are closely attached to the blood vessel rupture (perforated part) 19 by the expanded balloon 20, the head end part 1 is connected to the gelatin sponge particles 10 attached to the occlusion membrane, and the balloon shaft 21 is connected to the expanded balloon 20. The gelatin sponge particles 10 on the plugging membrane can obviously improve the success rate of plugging.

Preferably, the improved occlusion catheter of the present invention is used to note that the proximal portion has an intraluminal volume (3.14 × 0.32-3.14 × 0.1272 × 2) × 1300 ═ 235.7ul so that the amount of fluid injected through the branch catheter should not exceed 200 ul.

Preferably, the utility model provides an its inner wall coating of shutoff pipe is Polytetrafluoroethylene (PTFE) that coefficient of friction is extremely low to the friction of seal wire and pipe wall is controlled to the minimizing, does benefit to controlling of shutoff membrane. Preferably, use the utility model provides a shutoff pipe, when the shutoff was ended, should withdraw supplementary sacculus pipe earlier, slowly withdraw the shutoff membrane again to in the head end of shutoff pipe, if the hemostasis membrane is because of absorbing the inflation of moisture in the blood and can not get back to in the pipe cavity, need slowly withdraw to in the finger guide tube and along with guide the pipe withdraw to external together.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention should be covered by the present invention. It will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present invention as defined by the following claims.

Claims

1. An occlusion catheter for treating coronary perforation, which is characterized by comprising a catheter with a guide wire cavity and an occlusion film, wherein the interior of the catheter is connected with a control handle through two guide wires; the occlusion catheter is divided into a head end part, a distal end part and a proximal end part; the proximal portion is adjacent to the operating handle, and the distal portion is connected at one end to the proximal portion and at the other end to the head portion.

2. The occlusion catheter of claim 1, wherein the tip portion, the distal portion, and an extension of the distal portion to the proximal portion of the occlusion catheter are disposed within a continuous guidewire lumen parallel to the catheter lumen.

3. The occlusion catheter of claim 1, wherein the occlusion catheter has a lumen for receiving the occlusion membrane and its steering guidewire, and a protective sheath between the trailing end of the lumen and the steering handle.

4. The occlusion catheter of claim 1, wherein a head end portion of the occlusion catheter has a flap device.

5. The occlusion catheter of claim 1, wherein said occlusion membrane is comprised of a rhomboid or oval memory wire frame and a polyurethane membrane secured thereto.

6. The occlusion catheter of claim 1, wherein the wire frame of the occlusion membrane is connected to a steering handle via a steering guidewire.

7. The occlusion catheter of claim 1, wherein a branch catheter is disposed proximal to the operating handle, the branch catheter communicating with the main catheter through a side hole.