CN104174107A - Novel vessel sheath - Google Patents

Abstract

A novel vascular sheath, which includes a tearable sheath tube component (1) and an expansion tube component (2). The tearable sheath tube assembly (1) includes a rear cover (11), a rear cover (12), a tearable sheath seat (13), a tearable hemostasis valve (14), a tearable sheath tube (15), Snap buttons (16) and (17), side branch pipe (18), three-way valve (19). The expansion tube assembly (2) includes an expansion tube base (21) and an expansion tube (22). The invention belongs to a vascular interventional medical device, which can solve the problem that the existing vascular sheath cannot be completely withdrawn in some clinical uses, and can also avoid the defects of continuous blood leakage and easy formation of thrombus caused by the use of a tear-off vascular sheath. The new vascular sheath can seal the outflow of vascular blood during clinical use, and can also pinch the two handles (131) and (132) of the tearable sheath seat (13) when needed, and tear them outwards respectively After the sheath seat (13) is opened, the back cover (11) and (12) connected with it can tear the hemostatic valve (14), and the tearable sheath tube (15) will be divided into two halves along the midline, so that the blood vessel sheath can be separated from the Other instruments inserted inside it are separated and withdrawn.

Description

A new type of vascular sheath

technical field

The invention relates to a medical device, in particular to a medical device for establishing a channel from the outside to the blood vessel of a human body.

Background technique

Vascular interventional therapy has made great progress in recent years, especially cardiac interventional therapy and peripheral vascular interventional therapy. Such as interventional treatment of coronary heart disease, cardiac pacing, electrophysiological diagnosis and treatment, minimally invasive interventional treatment of congenital heart disease, interventional treatment of peripheral arteries and veins, vascular catheterization techniques, etc. These treatment methods are relatively complicated, especially during the treatment process, various instruments need to enter into the diseased parts of human organs or blood vessels, including main treatment instruments, auxiliary treatment instruments, diagnostic instruments, various drugs, etc. These treatments all require the establishment of a channel, the vascular sheath, to the blood vessel outside the body. The vascular sheath uses the vascular puncture technique to guide the vascular sheath to expand the skin and muscle tissue into the lumen of the epidermal blood vessel with a puncture guide wire, and then remove the puncture guide wire and dilation tube assembly so that the distal end of the tearable sheath assembly stays in the blood vessel, and the proximal end In vitro, in this way, a channel from the outside to the inner cavity of the blood vessel is established, which can be used for other instruments and drugs to enter the blood vessel or to monitor hemodynamics. With the promotion of technology and application, in the clinical process, various instruments may enter the human body through the proximal end of the vascular sheath. In some cases, the vascular sheath needs to be completely withdrawn first, but the rear end of the instrument passing through it is larger than the blood vessel. The inner diameter of the sheath, or other devices connected to the outside of the body, cannot withdraw from the vascular sheath, so the vascular sheath needs to be torn apart and completely withdrawn while withdrawing. However, the vascular sheaths that can be torn apart at present do not have hemostatic valves and side branch tubes that can be torn apart, which makes it impossible to prevent blood from leaking from the proximal end of the vascular sheath during arterial surgery. When injecting drugs or aspirating blood into the cavity, the suction device cannot be connected. Based on solving the above problems, the present invention designs a vascular sheath that can be torn apart into two halves, and the proximal end of the sheath tube is equipped with a tearable hemostatic valve and a side branch.

The present invention has the following advantages in clinical application, when performing diagnostic examination and treatment such as angiography, mapping, electrode insertion, cardiac pacing, tissue resection, and thrombus extraction. Due to the frequent entry and exit of the instrument in the sheath, it is easy to bring air, foreign matter, etc. into it, and it is easy to form a thrombus inside the sheath. At this time, a syringe can be used to connect with the three-way valve of the side branch. At the same time, the thrombus formed in the inner cavity of the sheath tube can be quickly extracted through the side branch cavity, and heparinized saline can be injected into the inner cavity of the sheath tube and the side branch tube to achieve heparinization of the tube cavity. At the same time, when needed, quickly inject emergency medicine into the blood vessel through the side branch three-way valve. Rapid disposal measures are possible.

At the same time, the present invention designs the hemostatic valve of the sheath tube as a cross-line slit type while ensuring the above-mentioned side branches, and a slit extends to the outer circumference of the hemostatic valve, through two semicircular designed back covers and the inside of the back cover. Sharp corner design, after the back cover is bonded and assembled, the sharp corner of the back cover will tightly press the tearable hemostatic valve on the tearable sheath seat. The tear-off sheath seat is designed as a tearable groove symmetrical on both sides. When the two handles of the tear-off sheath seat are opened with both hands and torn apart, the handle drives the back cover, the tear-off hemostasis valve and the tear-off sheath tube Split into two halves along a fixed route.

Contents of the invention

The invention is a new type of vascular sheath, which includes a tearable sheath tube assembly and an expansion tube assembly. The tearable sheath tube assembly includes a tearable sheath seat, a tearable back cover, a tearable hemostasis valve, and a Tear off the sheath tube, snap button, side branch tube and three-way valve. The expansion tube assembly includes an expansion tube seat and an expansion tube.

The tear-off back cover of the present invention is composed of two semicircular back covers, which have a raised sharp corner design inside, and form a concave-convex mating surface with the tear-off sheath seat, so that after being assembled by bonding, the two A tear-off seam is formed in the middle of the back cover. After the back cover is assembled, the inner hole has a protruding platform. After the expansion tube assembly is assembled with the tearable sheath tube assembly, the groove of the expansion tube assembly just forms an interference fit with the boss of the back cover, which can It is ensured that during the entire process of the vascular sheath entering the blood vessel, the distal end of the expansion tube will not move backward and be separated from the tearable sheath tube assembly due to resistance first. The sharp corner design in the back cover, after the back cover is bonded and assembled, the sharp corner of the back cover will tightly press the tearable hemostatic valve on the tearable sheath seat.

The tearable hemostatic valve of the present invention has a circular groove and a cross slit at the central position, wherein one slit is obviously longer than the other, and extends to the peripheral edge of the tearable hemostatic valve, and when assembled, the longer The slit of the corresponding to the slit of the back cover and the tearable slot of the tearable sheath seat. After the assembly, the tearable hemostatic valve is tightly pressed on the tearable sheath seat by the sharp corner of the back cover. The central groove of the tearable hemostatic valve faces the side of the back cover, which is convenient for other instruments to play a guiding role when passing through the tearable hemostatic valve during the operation, so that the instruments pass along the center of the tearable hemostatic valve, and at the same time, the tearable hemostatic valve The valve can form close contact with the outer surface of the passing device, so as to prevent the blood from leaking out.

There are two handles on both sides of the tearable sheath seat of the present invention, each of which has a snap button, and the tearable sheath tube is a fluoroplastic tube, which cannot be bonded and fixed with other polymer materials. After the button passes through the hole at the proximal end of the tearable sheath tube, the tearable sheath seat is fixed on it during injection molding, which can prevent the tearable sheath tube from being separated from the tearable sheath seat during the tearing process, and solves the problem of The problem that the torn sheath cannot be connected and fixed with the tearable sheath.

The side branch tube of the present invention is installed under the handle through one side of the tearable sheath seat, and the other end is connected with a single three-way valve, which together form a side branch leading to the inner cavity of the tearable sheath tube, which can provide thrombus in clinical use. Quick and convenient operations such as suction, drug injection, and heparinization of the sheath.

Both the distal end of the tearable sheath tube and the distal end of the expansion tube in the present invention have tapered conical heads, which can avoid damage of the sheath tube during the process of entering blood vessels. The inner diameter of the tip of the tearable sheath forms a zero-gap fit with the outer diameter of the expansion tube.

The purpose of the present invention is to realize by following a preferred technical scheme:

The back cover has a semicircular design, and a tearable gap is formed after assembly. The tearable hemostatic valve is mechanically cut to form a cross slit in the center, and one slit is longer, extending to the peripheral edge of the tearable hemostatic valve, but not cut completely. The tear-away hemostatic valve has a circular groove in the center. The tearable sheath is formed by injection molding, a process that secures the tearable sheath to the tearable sheath. Through the design of the mold structure, the tearable sheath seat after injection molding has two symmetrical tearable grooves, but it does not communicate with the inside of the tearable sheath seat. The sheath seat is the most vulnerable position along the tear groove and will be torn.

The tearable sheath of the present invention is an extruded fluoroplastic pipe. Through the design and process control of the extrusion die, two symmetrical tearable grooves are formed on the outer surface of the sheath after extrusion. After the proximal end of the tube is perforated, the part of the sheath tube is cut into two halves along the tearable groove, and after being assembled with the snap button, injection molding is performed.

The novel structure of the invention is simple and reasonable, and completely solves the non-tearability of the existing vascular sheath, and the inability of the existing tearable sheath to stop bleeding and to perform side branch extraction or injection. And through the special design, the fluorine plastic tube can be firmly connected with the injection molded parts, and the invention can fully meet the use requirements of the existing clinical vascular sheaths. It makes it convenient, fast and safe for other instruments to enter and exit blood vessels, and can greatly reduce the probability of thrombus or air entering blood vessels.

The diameter of the lumen of the novel vascular sheath sheath tube of the present invention is 1.00mm-5.0mm, and the length is 50mm-350mm. After the assembly is completed, the distal end of the tearable sheath tube is sealed off, the internal cavity of the tearable sheath tube component is pressurized from the three-way valve, the tearable hemostatic valve and the tearable sheath tube component are pressurized Each part can bear the pressure of 42Kpa without leakage.

Description of drawings

Fig. 1 is a schematic diagram of the assembly of a novel vascular sheath of the present invention;

Figure 2 is a partial sectional view of the new vascular sheath assembly

Figure 3 is an exploded view of the tearable sheath tube assembly;

Figure 4 is a partial sectional view of the assembly of the tearable sheath tube assembly;

Fig. 5 is a schematic diagram of a tearable hemostatic valve;

Fig. 6 is a sectional view of the back cover;

Figure 7 is a schematic structural view of the expansion tube assembly;

Among them: 1 tearable sheath assembly; 2 expansion tube assembly; 11, 12 rear cover; 13 tearable sheath seat; 14 can

Tear open hemostatic valve; 15 tearable sheath tube; 16, 17 snap button; 18 side branch tube; 19 three-way valve.

Detailed ways

In order to make the purpose, technical solution and advantages of the present invention clearer, a new type of vascular sheath of the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments; and the "distal end" and "near end" are Compared with the medical staff, the far end is called the distal end, and the one that is relatively close to the medical and surgical personnel is called the proximal end. The so-called proximal and distal ends are only relative, and there is no absolute distinction. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

This embodiment is designed according to many years of product application combined with the most extensive clinical needs. The existing vascular sheath cannot be torn in two halves, or cannot be assembled with tearable hemostatic valves, side branch tubes and three-way valves, resulting in product applications that cannot cover a wider range of operations, such as only for arterial vessels or only for For venous blood vessels, it can only be used for interventional treatment of coronary heart disease, or only for cardiac pacing treatment. However, the product of the embodiment of the present invention can greatly expand the scope of application of the product, such as interventional therapy for coronary heart disease, electrophysiology, cardiac pacing, peripheral vascular intervention, and central venous vascular intervention.

As shown in Figures 1 and 2, the novel vascular sheath of the present invention includes a tearable sheath assembly (1) and a dilation tube assembly (2). There is a groove (211) on the expansion tube seat (21) on the expansion tube assembly (2); the two semicircular rear covers (11) and (12) After the assembly is completed, there is a protrusion (111) along the inner circumferential direction. After the groove (211) and the protrusion (111) are assembled as shown in Figure 2, an interference fit is formed. When the tube assembly (2) and the tearable sheath tube assembly (1) are separated, a certain force must be exerted on the two components to separate, and this separation force is sufficient to ensure that the tube (22 ) after the distal end is subjected to resistance, the expansion tube assembly (2) will not be separated from the tearable sheath assembly (1). Through vascular puncture technology, a new type of vascular sheath is introduced into the blood vessel by the puncture guide wire, the tearable sheath assembly (1) is fixed, and the expansion tube assembly (2) is pulled out, thereby establishing a channel for entering the blood vessel from the outside.

Figure 3 is an exploded view of the tearable sheath tube assembly. The tearable sheath tube assembly (1) includes a back cover (11), a back cover (12), a tearable sheath seat (13), a tearable Open hemostatic valve (14), tearable sheath tube (15), snap buttons (16) and (17), side branch tube (18), three-way valve (19).

As shown in Figure 3, the tearable sheath tube (15) is a fluoroplastic tube with two symmetrical tearable grooves (151) on its outer surface, and the proximal end is cut into two along the tearable grooves (151). Fixed wings (152), and two through holes (153) are arranged on the fixed wings (152), and a hole (154) is arranged near the far end in one of the fixed wings (152), which can tear the sheath tube (15) The distal end presents a tapered conical tip (155), which can reduce damage to blood vessels.

As shown in Fig. 3 and Fig. 4, the tearable sheath seat (13) is connected together with the snap buttons (16), (17) and the tearable sheath tube (15) through an injection molding process. The tearable sheath seat (13) has two symmetrical handles (131) and (132), and the card table (138) matched with the back cover (11) and (12), which is connected with the handles (131) and (132) There are two opposite tearable grooves (133) in the vertical direction, the installation groove (134) and the platform (135) assembled with the tearable hemostatic valve inside, and the intubation seat (136) for installing the side branch (18) ). The snap button (16) passes through the through hole (153) of the tearable sheath tube (15) and the snap button (17) is connected together with the tearable sheath seat (13) through injection molding, so that the The tearable sheath tube (15) and the tearable sheath seat (13) meet a certain connection force.

As shown in Figure 5, the tearable hemostatic valve (14) is an elastic material with a cross slit at its central position, wherein the slit (141) is longer than the slit (142) and extends to its peripheral edge. There is a circular groove (143) at the center of the tearable hemostatic valve (14), and there is a protruding part (144) on the outer edge of the side opposite to the circular groove (143). The tearable hemostatic valve (14) is installed inside the proximal end of the tearable sheath seat (13), so that the slit (141) is aligned with the tearable groove (133), and the protruding part (144) is embedded in the installation groove (134) )Inside.

As shown in Figure 6, the back covers (11) and (12) are designed as two semicircles, with grooves (112) on the inner side of the far end, a circle of sharp corners (113) along the circumferential direction, and a groove (113) on the inner side of the proximal end. Protrusion (111), the two back covers are glued on the outside of the proximal end of the tearable sheath (13), and the groove (112) on it cooperates with the card platform (138) of the tearable sheath (13) . The sharp angle (113) presses the tearable hemostatic valve (14) on the platform (135) of the tearable sheath seat (13), at this time the tearable hemostatic valve (14) passes through the tearable sheath seat (13) ) of the proximal opening is sealed to form a hemostatic effect.

As shown in Figures 1 and 3, one end of the side branch tube (18) is installed on the intubation seat (136) of the tearable sheath seat (13), and the other end is connected to a three-way valve (19). Its inner cavity communicates with the inner cavity of the tearable sheath seat (13) through the hole (154) of the tearable sheath tube (15), and communicates with the distal end of the tearable sheath tube (15).

As shown in Figure 5, the expansion tube assembly (2) is composed of the expansion tube base (21) and the expansion tube (22). 12) There are protrusions (111) in the direction of the inner circumference to form an interference fit. The proximal end of the expansion tube seat (21) is an inner conical locking Luer connector, the lumen of which communicates along the lumen of the expansion tube (22), and can pass through a guide wire of 0.014 inches to 0.038 inches (0.35 mm to 1.0 mm). The distal end of the expansion tube presents a gradually tapered conical head end to reduce damage to blood vessels or human tissues when the tearable vascular sheath enters the human body.

The material of the new type of vascular sheath (15) is PTFE, FEP, ETFE and other fluoroplastics, which are formed into a tube body by extrusion molding or other processes, and ordinary tubes are difficult to tear in a straight line in the axial direction. The invention adopts the method of forming symmetrical tearing seams on the outer surface of the pipe during pipe extrusion molding or subsequent processing, and the depth of the seam can account for 10%-95% of the pipe wall thickness, so that the pipe can be torn along the axial line .

In this embodiment, the fluoroplastic tube has the characteristics of low frictional resistance and is difficult to bond or bond. In this case, through a special injection molding process and pre-treatment, the fluoroplastic tube can be firmly connected with the tearable sheath seat, and the operation is convenient.

The new vascular sheath in this embodiment has a simple structure and is easy to use, which can meet the application requirements of most clinical sheaths at present, and realizes the integrated design of the tearability of the vascular sheath, side branch pipeline and hemostatic performance, and provides The equipment selection and operation of medical staff have brought great convenience.

Finally, it should be noted that it is obvious that those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and equivalent technologies thereof, the present invention also intends to include these modifications and variations.

Claims (10)

1. A novel vascular sheath comprising: Tearable sheath assembly (1) and expansion tube assembly (2); The tearable sheath tube assembly (1) includes a rear cover (11), a rear cover (12), a tearable sheath seat (13), a tearable hemostasis valve (14), a tearable sheath tube (15) , snap buttons (16) and (17), side branch pipe (18), three-way valve (19); the expansion tube assembly (2) has an expansion tube seat (21) and an expansion tube (22); After the assembly of the tearable sheath tube assembly (1) is completed, there are two through the rear cover along the axis direction, a tearable hemostasis valve, a tearable sheath seat, and a tearable sheath tube, which are symmetrical along the diameter direction. Tearable seam, when the two handles of the tearable sheath are pinched and separated to the outside, the entire tearable sheath tube assembly will be torn along the tearable seam, so as to be separated from its interior through instruments; The tearable sheath tube assembly (1) has a side branch channel, which is composed of a side branch tube (18) and a three-way valve (19), and its lumen channel communicates with the inner cavity of the tearable sheath seat (13), And communicate with the inner cavity of the tearable sheath tube (15), the medical staff can inject medicine into the inner cavity of the tearable sheath tube assembly through the three-way valve, or draw blood in the blood vessel, and this channel can be used without changing other devices. Next, the thrombus in the blood vessel is extracted, and the drug is quickly injected into the blood vessel; The novel vascular sheath has tearability and simultaneously includes a tearable hemostatic valve (14), and the tearable hemostatic valve (14) has a tearable prefabricated slit. The tearable hemostatic valve (14) has a cross slit and a guide pit at its center, which can satisfy other instruments passing through the tearable hemostatic valve (14), the hemostatic valve can be opened smoothly, and ensure that the instrument is in its In the central position, the hemostatic valve is in close contact with the passing device, keeping no gaps, so as to prevent blood from leaking out. 2. The back cover (11) and (12) according to claim 1, characterized in that the back cover is a semicircular design, after the two back covers and the tearable sheath (13) are installed, use The corresponding adhesive glues the back cover and the tearable sheath seat together, and a gap is formed between the two back covers, and when the tearable sheath tube assembly is torn off, the back cover is first opened along the seam. 3. According to claim 1 and claim 2, when the two back covers are bonded to the tearable sheath seat, a tearable hemostatic valve (14) is installed in the middle, and the tearable hemostatic valve (14) There is a cross slit and a guide pit at its center, and one slit of the cross slit is longer and can extend to the outer peripheral edge of the silicone valve, and the slit is installed correspondingly to the slit of the two back covers. And the sharp corners of the two back covers tightly press the tearable hemostatic valve on the tearable sheath seat, and when the tearable sheath tube assembly is torn, the tearable hemostatic valve will be broken along the longer crack. Split into two halves. 4. The tearable sheath seat (13) according to claim 1, characterized in that there are two handles (131) and (132) on the tearable sheath seat (13), and the tearable sheath seat (13) has a tear groove (133) corresponding to the long crack of the tearable hemostatic valve (14). When tearing the tearable sheath tube assembly, the tearable sheath seat will be along the tearable groove. Tear in two halves. 5. The tearable sheath seat (13) according to claim 1 and claim 4, there is a side hole (137) under the handle (132) on one side to communicate with the inner cavity of the tearable sheath seat, and It protrudes from the outer side of the tearable sheath seat, and its shape has a circumferentially protruding edge, which can closely cooperate with the inner wall of the side branch tube to achieve sealing and prevent the side branch tube from falling off. 6. The other end of the side branch pipe (18) according to claim 1 and claim 5 is connected with a three-way valve (19), the three-way valve has a knob that can be selectively opened and closed, and can be adjusted according to the needs of medical staff. , turn the knob to close or open the channels in the three directions respectively. The three-way valve, the side branch tube and the tearable sheath seat form an inner cavity channel, and the channel communicates with the inner cavity of the tearable sheath tube. 7. The tearable sheath tube (15) according to claim 1 is made of fluoroplastic, which has smoothness. There are two tearing grooves corresponding to the tearing grooves of the tearable sheath seat on the outside, extending from the proximal section to the far end. The distal end of the tearable sheath tube presents a tapered and tapering feature. The cavity and the dilating tube are in zero-gap fit, which can minimize the damage caused to the skin, muscle tissue and blood vessel wall when the vascular sheath enters the blood vessel. The near section of the tearable sheath tube is completely separated into two halves along a section of the tearing groove, and there is a hole in each of the two halves. 8. According to claim 1 and claim 7, the two snap buttons (16) and (17), the tearable sheath seat and the rear cover are all injection molded from polymer materials. The two snap buttons pass through the two holes in the proximal section of the tearable sheath respectively, and are fixed on the two handles of the tearable sheath by injection molding. No fusion, the invention can ensure that when the vascular sheath is torn, the two handles can drive the tearable sheath tube to be torn smoothly along the tearing seam through the snap buttons. 9. The expansion tube assembly (2) according to claim 1, characterized in that the expansion tube seat (21) has a circumferential groove, which can form an interference fit with the inner hole of the rear cover To ensure that the expansion tube assembly and the tearable sheath tube assembly are assembled, and the expansion tube assembly will not be retreated due to resistance when entering a muscle or blood vessel. The distal end of the expansion tube presents a gradually tapering conical structure, which can minimize the damage caused by the expansion tube to the skin, muscle tissue and blood vessel wall when entering the blood vessel. 10. The novel vascular sheath according to claim 1, wherein the tearable sheath has an inner diameter of 1.0mm-5.0mm and a length of 50mm-350mm. After the assembly is completed, the distal end of the tearable sheath tube is sealed off, the internal cavity of the tearable sheath tube component is pressurized from the three-way valve, the tearable hemostatic valve and the tearable sheath tube component are pressurized Each part can bear the pressure of 42Kpa without leakage.