CN111671991A

CN111671991A - Double-balloon access catheter for realizing vascular access reconstruction

Info

Publication number: CN111671991A
Application number: CN202010487069.7A
Authority: CN
Inventors: 杨贵强
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-06-01
Filing date: 2020-06-01
Publication date: 2020-09-18

Abstract

The invention relates to a double-balloon access catheter for realizing vascular access reconstruction, which comprises: the catheter comprises an access catheter, a front expansion balloon, a rear expansion balloon, a front filling system and a rear filling system. The channel catheter is formed by fusing a single-cavity tube with two soft ends and a double-cavity tube with a stainless steel woven net in the middle into a whole, wherein the double-cavity tube is a large cavity and a small cavity and is used as a blood channel and a filling liquid channel. The expansion sacculus is a high-pressure resistant sacculus made of high polymer materials. The filling system consists of a filling passage (comprising a small cavity part, a three-way part, a connecting hose and a needle tube fixing part with a luer connector), a filling mechanism and a filling solution. When the filling mechanism is compressed, the expansion saccule is propped up by the filling liquid, and the filling operation of the saccule is realized. When the filling mechanism stretches, the contraction operation of the balloon is realized. The invention can construct a temporary blood passage in an emergency state, reduce the loss of blood, ensure the smoothness of the blood vessel passage and reduce the death rate and disability rate.

Description

Double-balloon access catheter for realizing vascular access reconstruction

Technical Field

The invention belongs to the field of practical medical instruments, and particularly relates to a double-balloon access catheter for realizing vascular access reconstruction.

Background

In modern war or serious traffic accidents, open injuries of the limbs and trunk positions of people occur in a large number, wherein the aorta or the main vein is broken in a large number of cases, further causing a large gush of blood, and finally endangering the lives of the injured people. For the treatment of such injuries, the existing rescue methods are mainly "compression hemostasis" (for bleeding caused by artery damage, "proximal compression hemostasis" is used, and for bleeding caused by vein damage, "distal compression hemostasis" is used). This procedure completely blocks the blood flow and, although it stops bleeding, it has two undesirable consequences: the "proximal compression hemostasis" method can block blood flow, and if the blood supply is blocked for a long time (usually more than 30 minutes), the tissue or organ at the far end can not be sufficiently supplied with nutrition and oxygen, and then the tissue or organ can be necrotized; the "distal compression hemostasis" method results in no blood flow back to the heart, resulting in a large volume of blood being trapped in the obstructed area, which can cause thrombosis and edema if jammed for a long period of time (typically greater than 30 minutes), as well as tissue and organ necrosis.

In addition to the "hemostasis by compression" method, there is no better method to prevent the massive gushing of blood due to the "rupture of the aorta or the main vein".

Disclosure of Invention

The invention aims to provide a double-balloon access catheter for realizing vascular access reconstruction, which is suitable for establishing a new vascular access at a broken blood vessel position through the filling of a balloon and the connection of a channel in the catheter in open type vascular rupture injury, so as to prevent massive hemorrhage, further achieve the purposes of reducing injury, saving lives of injured people and preventing complications.

In order to achieve the above purpose, the invention adopts the following technical scheme.

A dual balloon access catheter for effecting vascular access reconstruction, comprising: the catheter comprises an access catheter, a front expansion balloon, a rear expansion balloon, a front filling system and a rear filling system.

The channel catheter consists of a front single-cavity tube, a double-cavity tube and a rear single-cavity tube, wherein the double-cavity tube consists of two cavity catheters with stainless steel woven nets, the two cavities are large and small and are divided into a large cavity and a small cavity, and the large cavity of the front single-cavity tube and the large cavity of the double-cavity tube are communicated with the rear single-cavity tube to form a blood channel. The front section of the small cavity is used as a partial filling channel of the front dilatation balloon; the rear section of the small cavity is used as a partial filling channel of the rear dilatation balloon; the two sections are sealed and isolated by glue.

The front expansion saccule and the rear expansion saccule are respectively positioned at the front end and the rear end of the catheter. The passage catheter penetrates through the front expansion balloon and the rear expansion balloon and is firmly bonded with the front expansion balloon and the rear expansion balloon to form a closed space. The small cavity sections of the double-cavity tube in the front expansion balloon and the rear expansion balloon are provided with a notch, so that the front expansion balloon and the rear expansion balloon can be communicated with the corresponding small cavities to be used as a flow passage for filling liquid.

The front filling system consists of a filling passage (comprising a small cavity part in a double-cavity tube, a three-way part, a connecting hose and a needle tube fixing part with a luer connector), a filling mechanism (consisting of a medical injector with a locking device), filling solution in the filling mechanism and the like. Wherein: the double-cavity tube penetrates through the three-way piece, the three-way piece is hermetically connected with the double-cavity tube and is communicated with the front expansion balloon through a small hole on a small cavity on the double-cavity tube; two ends of the connecting hose are respectively connected with the bypass of the three-way piece and the needle tube fixing piece; the needle tube fixing piece is provided with a luer connector at the head end for convenient connection with a filling mechanism. The filling mechanism is composed of a medical injector with a locking device, and can conveniently perform filling operation, filling maintenance, contraction operation and contraction maintenance. The filling liquid is formed by normal saline.

The composition of the rear filling system is the same as that of the front filling system.

Furthermore, the double-cavity tube consists of three parts from inside to outside: the inner part of the structure is a big-small double-cavity structure and is made of nylon, high-density polyethylene or polytetrafluoroethylene; the middle layer is a stainless steel wire mesh-shaped woven structure, and the outer layer is made of polyurethane or a block polyether amide elastomer.

Furthermore, the head ends of the front single-cavity tube and the rear single-cavity tube are of conical structures, and arc angles are arranged at the head ends, so that the damage to the vessel wall caused by the catheter in the process of inserting into a vessel can be effectively reduced, and the material is soft polyurethane or block polyether amide.

Further, the effective length range of the catheter body is 30cm-100 cm.

Furthermore, the front expansion saccule and the rear expansion saccule are non-compliant saccules and are made of materials such as nylon, polyethylene terephthalate and the like.

Furthermore, the inflated diameter of the front dilatation balloon is 5-10mm, and the inflated length is 15-30 mm.

Further, the inflated diameter of the post-dilatation balloon is 5-10mm, and the inflated length is 15-30 mm.

Further, the distance between the front expansion saccule and the front end of the catheter is 3-5 cm.

Further, the rear expansion balloon is 3-5cm away from the rear end of the catheter.

Furthermore, the tee joint piece is made of transparent polycarbonate material.

Furthermore, the distance between the three-way piece at the front end and the front expansion saccule is 3-5 cm.

Furthermore, the distance between the three-way piece at the rear end and the rear expansion saccule is 3-5 cm.

Furthermore, the connecting hose is made of polyamide material.

Furthermore, the needle tube fixing piece with the luer connector is made of transparent polycarbonate material.

Furthermore, the filling mechanism is a medical injector with a luer connector and capable of being locked, and is made of high polymer plastic materials.

Further, the filling liquid is constituted by physiological saline (0.9% sodium chloride aqueous solution).

The invention has the beneficial effects.

The double-balloon access catheter for realizing the vascular access reconstruction can utilize the front expansion balloon (2) and the rear expansion balloon (3) at two ends to respectively seal two ends of a broken vascular structure to prevent blood from flowing out of a body when a main blood vessel is broken. Meanwhile, after the front expansion saccule (2) and the rear expansion saccule (3) at the two ends seal the broken blood vessel, the blood returns to the body again through the blood channel (14), and the blood loss is prevented.

Compared with the original hemostasis mode, the invention has great advantages that the temporary vascular access can be provided for open vascular injury, and the blood flow is not required to be blocked while hemostasis is performed, so that the effect of protecting tissues or organs at the far end can be achieved. Greatly improves the survival ability of the wounded and effectively protects the tissue and the organ at the far end of the heart.

Drawings

Fig. 1 is a structural schematic diagram of a double-balloon access catheter for achieving vascular access reconstruction provided by the invention.

FIG. 2 is a cross-sectional view of a dual lumen tube.

FIG. 3 is a schematic view of an aperture in the balloon communicating with a small cavity in the dual lumen tube.

FIG. 4 is a schematic view of a tee in communication with a small lumen in a dual lumen tube.

Fig. 5 is a schematic view of the double-balloon access catheter for realizing vascular access reconstruction, which is provided by the invention, in the use process of the double-balloon access catheter in the case of arterial rupture.

Fig. 6 is a schematic view of the double-balloon access catheter for realizing vascular access reconstruction, which is provided by the invention, in the use process of the double-balloon access catheter in the 'vein rupture condition'.

Fig. 7 is a schematic view of the double-balloon access catheter for realizing vascular access reconstruction provided by the invention in the use process of the double-balloon access catheter in the case of simultaneous fracture of the artery and the vein.

The labels in the figure are: the catheter comprises a passage catheter 1, a front expansion balloon 2, a rear expansion balloon 3, a front filling system 4, a rear filling system 5, a front single-lumen tube 11, a double-lumen tube 12, a rear single-lumen tube 13, a large cavity 121, a small cavity 122, a filling passage 41, a filling mechanism 42, filling liquid 43, a tee joint part 411, a connecting hose 412 and a needle tube fixing part 413 with a luer connector.

Detailed Description

The invention is further explained with reference to the figures and the specific examples. It is to be understood that the embodiments described herein are illustrative only and are not limiting upon the present invention.

As shown in fig. 1, a double-balloon access catheter for achieving vascular access reconstruction of the present embodiment includes: the catheter comprises an access catheter 1, a front dilatation balloon 2, a rear dilatation balloon 3, a front filling system 4 and a rear filling system 5.

The access catheter consists of a front single-cavity tube, a double-cavity tube and a rear single-cavity tube, wherein the double-cavity tube is composed of two cavity catheters with stainless steel woven nets as shown in figure 2, the two cavities are one large cavity and one small cavity and are divided into a large cavity and a small cavity, and the front single-cavity tube, the large cavity of the double-cavity tube and the rear single-cavity tube are communicated with each other to form a blood channel. The front section of the small cavity is used as a partial filling channel of the front dilatation balloon; the rear section of the small cavity is used as a partial filling channel of the rear dilatation balloon; the two sections are sealed and isolated by glue.

The front expansion saccule and the rear expansion saccule are respectively positioned at the front end and the rear end of the catheter. The passage catheter penetrates through the front expansion balloon and the rear expansion balloon and is firmly bonded with the front expansion balloon and the rear expansion balloon to form a closed space. A small cavity section of the double-cavity tube in the front expansion balloon and the rear expansion balloon is provided with a notch, so that the front expansion balloon and the rear expansion balloon can be communicated with the corresponding small cavities to be used as a flowing channel of filling liquid, and the small cavity section is shown in fig. 3.

The front filling system consists of a filling passage (comprising a small cavity part in a double-cavity tube, a three-way part, a connecting hose and a needle tube fixing part with a luer connector), a filling mechanism (consisting of a medical injector with a locking device), filling solution in the filling mechanism and the like. Wherein: the double-cavity tube penetrates through the three-way piece, the three-way piece is hermetically connected with the double-cavity tube and is communicated with the front expansion balloon through a small hole on a small cavity on the double-cavity tube; two ends of the connecting hose are respectively connected with the bypass of the tee joint part and the needle tube fixing part, as shown in figure 4; the needle tube fixing piece is provided with a luer connector at the head end for convenient connection with a filling mechanism. The filling mechanism is composed of a medical injector with a locking device, and can conveniently perform filling operation, filling maintenance, contraction operation and contraction maintenance. The filling liquid is formed by normal saline.

Further, the effective length of the catheter body ranges from 30cm to 100cm, and the length is preferably 50 cm.

Furthermore, the front expansion saccule and the rear expansion saccule are non-compliant saccules, are made of materials such as nylon and polyethylene terephthalate, and are preferably made of nylon materials.

Further, the inflated diameter of the front dilatation balloon is 5-10mm, preferably 8mm, and the inflated length is 15-30mm, preferably 20 mm.

Further, the inflated diameter of the post-dilatation balloon is 5-10mm, preferably 8mm, and the inflated length is 15-30mm, preferably 20 mm.

Further, the distance between the front expansion balloon and the front end of the catheter is 3-5cm, and the distance is preferably 4 cm.

Further, the rear expansion balloon is 3-5cm away from the rear end of the catheter, and preferably 4cm away.

Furthermore, the tee joint piece is made of transparent polycarbonate material.

Further, the three-way piece at the front end is 3-5cm away from the front dilatation balloon, and the distance is preferably 4 cm.

Further, the distance between the three-way piece at the rear end and the rear dilatation balloon is 3-5cm, and the preferred distance is 4 cm.

Furthermore, the connecting hose is made of polyamide material.

In the practical use process of the double-balloon passage catheter in the embodiment, the front end of the blood vessel fracture position can be fully blocked by the aid of the filling of the front expansion balloon, blood can be prevented from flowing out further, a circulation passage can be reserved for blood, the blood is conveyed to the position of a blood vessel below through the fracture position, and meanwhile, the blood vessel below is blocked by the aid of the filling of the rear expansion balloon, and the blood is prevented from flowing out of a fracture below. Thus ensuring the normal circulation of blood and avoiding the injury or necrosis of the far-end organ caused by the blockage of the blood vessel.

Example one is implemented.

As shown in FIG. 5, when "aortic rupture" occurs, the specific operation method of the present invention is as follows:

when the open type 'aorta rupture' injury occurs, the position of a blood vessel with continuous and massive hemorrhage of an injured person is observed, and the position is the position of the blood vessel of the bleeding aorta;

the single-lumen tube at the front end of the product is put into a bleeding aorta blood vessel against the bleeding direction, and is continuously sent into the catheter, and the front dilatation balloon is also sent into the aorta blood vessel, so that the tail end of the front dilatation balloon can enter the position of about 15-20 mm inside the blood vessel.

The filling mechanism in the filling system before slowly promoting, with filling liquid push among them before expanding the sacculus in, observe the hemorrhage condition of blood vessel end simultaneously, if the hemorrhage vascular stops bleeding, simultaneously, have blood to flow out in the single lumen pipe of pipe rear end, can stop filling liquid's push, with filling mechanism locking, from filling mechanism's scale position, note down the propelling movement position this moment. And completing the filling operation of the front dilatation balloon.

Finding out the damaged blood vessel position at the other end, placing the single-lumen tube at the rear end of the catheter into the blood vessel, continuously feeding the catheter, and feeding the post-dilatation balloon into the aorta blood vessel, wherein the tail end of the post-dilatation balloon can enter the position of about 15-20 mm inside the blood vessel.

The filling mechanism in the filling system after slowly pushing pushes the filling solution in the filling mechanism to push the back expansion saccule, the filling mechanism is pushed to the position consistent with the pushing position of the front end filling mechanism, filling operation can be stopped, and the filling mechanism is locked. And completing the filling operation of the dilatation balloon.

At this time, the blood passage reconstruction operation in the case of aortic rupture can be completed.

Example two is implemented.

As shown in fig. 6, when "main vein rupture" occurs, the specific operation method of the present invention is as follows:

when the open injury of 'main vein rupture' occurs, the position of a blood vessel with continuous and massive hemorrhage of the injured person is observed, and the position is the position of the blood vessel of the main vein with hemorrhage;

the single lumen tube at the front end of the product of the invention is put into the bleeding main vein vessel against the bleeding direction, and is continuously sent into the catheter, and the front dilatation balloon is also sent into the main vein vessel, so as to ensure that the tail end of the front dilatation balloon can enter the position of about 15-20 mm inside the vessel.

At this time, the blood passage reconstruction operation in the case of the rupture of the main vein can be completed.

Example three was implemented.

As shown in fig. 7, when "simultaneous rupture of aorta and main vein" occurs, the specific operation method of the present invention is as follows:

when the injury of 'simultaneous rupture of aorta and main vein' occurs, the position of the blood vessel of the injured person with continuous and massive hemorrhage is observed, and the position is the position of the blood vessel of the aorta;

a single-lumen tube at the front end of the product of the invention is put into a bleeding aorta blood vessel against the bleeding direction, and is continuously sent into a catheter, and the front dilatation balloon is also sent into the aorta blood vessel, so that the tail end of the front dilatation balloon can enter the position of about 15-20 mm inside the blood vessel.

The reconstruction operation of the blood passage of 'aortic rupture' can be completed.

Then observing the position of the blood vessel with continuous and massive hemorrhage reappeared by the wounded, wherein the position is the position of the main vein blood vessel with hemorrhage;

the single-lumen tube at the front end of another product according to the invention is put into the bleeding main vein against the bleeding direction, and is continuously sent into the catheter, and the front dilatation balloon is also sent into the main vein, so that the tail end of the front dilatation balloon can enter the position of about 15-20 mm inside the blood vessel.

The reconstruction operation of the blood passage can be completed when the main vein is broken.

At this time, the blood passage reconstruction operation in the case of simultaneous rupture of the aorta and the main vein can be completed.

The double-balloon access catheter described in the above embodiment can seal both ends of a broken vascular structure with the front dilatation balloon (2) and the rear dilatation balloon (3) at both ends, respectively, to prevent blood from flowing out of the body. Meanwhile, after the front expansion saccule (2) and the rear expansion saccule (3) at the two ends seal the broken blood vessel, the blood returns to the body again through the blood channel (14), and the blood loss is prevented. Compared with the original hemostasis mode, the invention has great advantages, can provide a temporary blood vessel access for open type blood vessel injury, does not need to block the flow of blood while hemostasis is performed, and can achieve the effect of protecting tissues or organs at the far end. Greatly improves the survival ability of the wounded and effectively protects the tissue and the organ at the far end of the heart.

It will be understood that the structure of the front and rear ends of the product of the present invention is the same, and the term "front" as used herein refers to the direction that enters the lesion first during use, and belongs to the "front" in the operation sequence. Similarly, the term "after" as used herein refers to "after" in the order of operation.

Although specific embodiments of the present invention have been described above, it will be understood by those skilled in the art that this is by way of illustration only, the scope of the present invention being defined by the appended claims, and that changes or modifications may be made to these embodiments by those skilled in the art without departing from the principles and spirit of the invention, and such changes and modifications are within the scope of the present invention.

Claims

1. A dual balloon access catheter for effecting vascular access reconstruction, characterized by: the double-balloon access catheter comprises: the catheter comprises a passage catheter (1), a front expansion balloon (2), a rear expansion balloon (3), a front filling system (4) and a rear filling system (5). The access catheter (1) consists of a front single-cavity catheter (11), a double-cavity catheter (12) and a rear single-cavity catheter (13), wherein the double-cavity catheter (12) consists of two cavity catheters with stainless steel woven nets, the two cavities are large and small and are divided into a large cavity (121) and a small cavity (122), and the front single-cavity catheter (11) and the rear single-cavity catheter (13) are communicated with the large cavity (121) of the double-cavity catheter (12) to form a blood channel (14). The front expansion saccule (2) and the rear expansion saccule (4) are non-compliant saccules, two ends of the front expansion saccule (2) and the rear expansion saccule (4) are connected with the outer surface of the double-cavity tube (12) to form a sealed structure, and small holes are arranged inside the sealed structure of the front expansion saccule (2) and the rear expansion saccule (4) and communicated with a small cavity (122) of the double-cavity tube; in order to keep the front expansion balloon (2) and the rear expansion balloon (4) independent and free from mutual influence, sealing glue (1221) is used for sealing in the middle of the small cavity (122). The front filling system (4) consists of a filling passage (41) (comprising a small cavity (122) part in a double-cavity tube (12), a three-way piece (411), a connecting hose (412), a needle tube fixing piece (413) with a luer connector), a filling mechanism (42) (consisting of a medical injector with a locking device), a filling solution (43) in the filling passage, and the like, wherein: the double-cavity tube (12) penetrates through the three-way piece (411), the three-way piece (411) is hermetically connected with the double-cavity tube (12), and the double-cavity tube is communicated with the front expansion balloon (2) through a small hole on a small cavity (122) on the double-cavity tube (12); two ends of the connecting hose (412) are respectively connected with a bypass of the three-way piece (411) and the needle tube fixing piece (413); the head end of the needle tube fixing piece (413) is provided with a luer joint which is convenient to be connected with the filling mechanism (42). The back filling system (5) and the front filling system (4) have the same composition. The filling mechanism (42) is composed of a medical injector with a locking device, and can conveniently perform filling operation, filling maintenance, contraction operation and contraction maintenance. The filling liquid (43) is formed by normal saline.

2. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the double-cavity tube (12) consists of three parts: the inner part of the structure is a big-small double-cavity structure and is made of nylon, high-density polyethylene or polytetrafluoroethylene; the middle layer is a stainless steel wire mesh-shaped woven structure, and the outer layer is made of polyurethane or a block polyether amide elastomer.

3. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the front single-cavity tube (11) and the rear single-cavity tube (13) are in single-cavity tube structures and made of soft polyurethane or block polyether amide.

4. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the front expansion sacculus (2) and the rear expansion sacculus (4) are non-compliant sacculus made of materials such as nylon, polyethylene terephthalate and the like.

5. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the tee joint piece (411) is made of transparent polycarbonate material.

6. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the connecting hose (412) is made of polyamide material.

7. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the needle tube fixing piece (413) with the luer connector is made of transparent polycarbonate material.

8. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the filling mechanism (42) is a medical injector with a luer connector and capable of being locked. The material is a high molecular plastic material.

9. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the filling liquid (43) is composed of physiological saline (0.9% sodium chloride aqueous solution).

10. A dual balloon access catheter for effecting vascular access reconstruction as recited in claim 1, wherein: the inflated diameter of the front dilatation balloon (2) is 5-10mm, and the inflated length is 15-30 mm; the inflated diameter of the rear dilatation balloon (4) is 5-10mm, and the inflated length is 15-30 mm.