CN215916129U

CN215916129U - Binary channels sheath pipe

Info

Publication number: CN215916129U
Application number: CN202122166756.1U
Authority: CN
Inventors: 李岩恒; 刘智勇; 王嬿
Original assignee: Forqaly Medical Shanghai Co ltd
Current assignee: Forqaly Medical Shanghai Co ltd
Priority date: 2021-09-08
Filing date: 2021-09-08
Publication date: 2022-03-01
Anticipated expiration: 2031-09-08

Abstract

The utility model discloses a double-channel sheath tube which comprises a sheath tube body, wherein the sheath tube body is provided with a main channel and an auxiliary channel, and the main channel is provided with a first cavity allowing a blood pumping catheter to pass through; the auxiliary channel is provided with a second cavity, a blocking wire is arranged in the second cavity, one end of the blocking wire blocks a far-end port of the auxiliary channel, the other end of the blocking wire penetrates out of the hemostasis valve, the hemostasis valve is arranged at the near end of the auxiliary channel, and the hemostasis valve blocks a near-end port of the auxiliary channel. According to the double-channel sheath tube provided by the utility model, the hemostatic valve is arranged at the near end of the auxiliary channel, so that the blocking wire of the second cavity can be separated and sealed from the hemostatic valve, the bleeding risk is reduced, and bleeding is reduced when the guide wire is replaced or pressure measurement is carried out; the sealing structure on the accessible hemostasis valve injects the thrombolysis material into the second chamber, avoids directly inserting the thrombus risk that the blood vessel brought with shutoff silk or seal wire.

Description

Binary channels sheath pipe

Technical Field

The utility model relates to the field of medical instruments, in particular to a double-channel sheath tube.

Background

A blood pumping catheter is an apparatus capable of pumping blood in a heart into an artery, the apparatus can be introduced into the heart through surgery or skin, in the field of percutaneous ventricular assist, the blood pumping catheter enters the heart through a femoral artery or an axillary artery, the common route is that the catheter head end of the blood pumping catheter passes through a main channel of a double-channel sheath body to be inserted into a human blood vessel and works after reaching the appointed position of a left ventricle, at the moment, the internal part of the double-channel sheath body is inserted into the human blood vessel, the external part of the double-channel sheath body passes through a suture pad by a medical wire and is fixed on the skin outside the human body, when the catheter is withdrawn from the left ventricle to the outside of the body, if a new catheter is required to be inserted into the heart again, in order to reduce the operation flow of a doctor, before the catheter withdraws the human blood vessel, a guide wire needs to be inserted into a secondary channel of the double-channel sheath body which is fixed on the skin and inserted into the human blood vessel, the catheter is reserved in a blood vessel of a human body in advance, and a newly inserted catheter can be smoothly inserted into the left ventricle along the reserved guide wire.

The existing double-channel sheath has a first cavity for a part of a percutaneous pump to pass through, and a second cavity with the size set to be used for guide wire insertion, when the guide wire is not inserted or used for pressure measurement, the second cavity comprises a plugging wire used for plugging the second cavity, and the plugging wire comprises a head and a plugging wire body which are integrally arranged. This structure two-chamber sheath is at the operation in-process, if need new pipe reinsert in vivo heart, need earlier extract the second chamber with integrative head and the shutoff silk body that sets up together, insert the guide wire into the second chamber again, thereby realize the guide wire and reserve in human blood vessel, at this in-process, the second chamber is exposed in the air, blood is outside continuous discharge under the pressure effect, need the quick skilled operation of doctor to insert the guide wire internal this moment, in order to avoid the too much loss of blood, this kind of operation requires very high to doctor's skill, the controllability is relatively poor, if this kind of state duration is longer, will cause the patient to lose blood too much, the risk is great. In addition, when the second cavity is applied to in vivo invasive pressure monitoring, the plugging wire body, the head and the sheath body need to be separated, and blood can enter the second cavity under the action of the difference between the pressure inside and outside the blood vessel. After the doctor connects the pressure monitoring pipeline joint with the sheath body joint, blood in the second cavity can be in an approximately static state in the cavity for a long time, and therefore thrombosis is caused. After the invasive pressure monitoring is finished, if a guide wire needs to enter a human blood vessel through a second cavity, thrombus is easily directly brought into the blood vessel to cause stroke risk. Thus, there is a need for improvements and enhancements in the art.

SUMMERY OF THE UTILITY MODEL

The technical problem to be solved by the utility model is to provide a double-channel sheath tube, wherein a hemostasis valve is arranged at the near end of a secondary channel, so that the bleeding risk is reduced.

The utility model provides a double-channel sheath tube for solving the technical problems, which comprises a sheath tube body, wherein the sheath tube body is provided with a main channel and an auxiliary channel, and the main channel is provided with a first cavity allowing a blood pumping catheter to pass through; the auxiliary channel is provided with a second cavity, a blocking wire is arranged in the second cavity, one end of the blocking wire blocks a far-end port of the auxiliary channel, the other end of the blocking wire penetrates out of the hemostasis valve, the hemostasis valve is arranged at the near end of the auxiliary channel, and the hemostasis valve blocks a near-end port of the auxiliary channel.

Further, the hemostatic valve comprises a shell and a flexible membrane, wherein the shell is connected with the proximal end of the secondary channel through a locking structure, and the flexible membrane is arranged at the top end of the shell; the flexible membrane blocks the near-end port of the auxiliary channel, and the blocking wire penetrates through the flexible membrane and enters the second cavity.

Further, the flexible membrane is provided with a weakened area, and the blocking thread penetrates through the weakened area of the flexible membrane and enters the second cavity.

Further, the locking structure comprises a female luer connector arranged on the shell and a male luer connector arranged at the proximal end of the secondary channel, and the female luer connector is in threaded locking or buckling locking with the male luer connector.

Further, the flexible membrane is a sealing silica gel sheet, and the sealing silica gel sheet is bonded, welded or in interference connection with the shell.

Further, the main channel is provided with an exhaust pipe communicated with the first cavity.

Further, a main channel sheath cap is connected to the proximal end of the main channel, and a sealing member is arranged at the joint of the main channel and the main channel sheath cap.

Further, the sealing member includes first sealing silica gel circle and the second sealing silica gel circle that sets gradually.

Further, the outer diameter of the distal end of the blocking wire is slightly larger than the inner diameter of the distal end of the second cavity, so that the distal end of the blocking wire and the distal end of the second cavity are in interference fit to block the distal end port of the secondary channel.

Further, sheath body outer wall is provided with sews up the pad, it is provided with the fixed sleeving to sew up the pad, the fixed sleeving sets up around sheath body outer wall, it fixes at sheath body outer wall through the fixed sleeving to sew up the pad, it has seted up the fixed orifices of sewing up to sew up on the pad.

Further, the locking sleeve of the suture mat includes a constant diameter section extending distally to form a variable diameter section that decreases in diameter from the proximal end to the distal end.

Compared with the prior art, the utility model has the following beneficial effects: according to the double-channel sheath tube provided by the utility model, the hemostatic valve is arranged at the near end of the auxiliary channel, so that the blocking wire of the second cavity can be separated and sealed from the hemostatic valve, the bleeding risk is reduced, and bleeding is reduced when the guide wire is replaced or pressure measurement is carried out; the sealing structure on the accessible hemostasis valve injects the thrombolysis material into the second chamber, avoids directly inserting the thrombus risk that the blood vessel brought with shutoff silk or seal wire.

Drawings

FIG. 1 is a schematic diagram illustrating a split-up of a two-channel sheath according to an embodiment of the present invention;

FIG. 2 is a schematic diagram of a two-channel sheath application in accordance with an embodiment of the present invention;

FIG. 3 is a schematic view of a hemostatic valve according to an embodiment of the utility model;

FIG. 4 is a schematic view of another angle configuration of a hemostatic valve according to an embodiment of the utility model;

FIG. 5 is a schematic view of a hemostatic valve having a weakened area according to an embodiment of the utility model;

FIG. 6 is an enlarged view of the hemostatic valve of FIG. 1;

FIG. 7 is a schematic view of a suture mat according to an embodiment of the present invention;

FIG. 8 is a schematic view of the application of the suture mat and the double channel sheath in the embodiment of the present invention.

In the figure: 1. a sheath body; 2. plugging wires; 3. a hemostatic valve; 4. a primary channel sheath cap; 5. a first sealing silica gel ring; 6. a second sealing silica gel ring; 7. a blood pumping conduit; 9. a suture mat; 11. a main channel; 12. a secondary channel; 13. an exhaust pipe; 14. a male luer fitting; 31. a housing; 32. a flexible film; 33. a weakened region; 34. a female luer fitting; 35. sealing the silica gel sheet; 91. a fixed diameter section; 92. a limiting ring; 93. a variable diameter section; 94. and (5) sewing the fixing hole.

Detailed Description

The utility model is further described below with reference to the figures and examples.

In the following embodiments, "distal" refers to a direction away from the doctor in actual operation, and "proximal" refers to a direction closer to the doctor in actual operation.

FIG. 1 is a schematic diagram illustrating a split-up of a two-channel sheath according to an embodiment of the present invention; fig. 2 is a schematic diagram of the application of the two-channel sheath according to the embodiment of the present invention.

Referring to fig. 1 and 2, the two-channel sheath according to the embodiment of the present invention includes a sheath body 1, the sheath body 1 is provided with a main channel 11 and an auxiliary channel 12, the main channel 11 is formed with a first cavity for allowing the blood-pumping catheter 7 to pass through; the secondary channel 12 is formed with a second cavity, a plugging wire 2 is arranged in the second cavity, one end of the plugging wire 2 plugs the far end port of the secondary channel 12, the other end of the plugging wire penetrates out of the hemostatic valve 3, the hemostatic valve 3 is arranged at the near end of the secondary channel 12, and the hemostatic valve 3 plugs the near end port of the secondary channel 12.

Specifically, the blood pumping catheter enters the human body percutaneously through the Seldinger technology, the main channel 11 of the double-channel sheath is provided with a first cavity allowing the blood pumping catheter 7 to pass through, and the auxiliary channel 12 is provided with a second cavity accommodating a guide wire to pass through, so that a guide wire passage for maintaining a vascular incision after the guide sheath can be torn off can be realized.

Blood pumping catheters are a class of interventional catheter-like devices that enable blood pumping. The pump part in the pump blood catheter can be positioned in the heart or a blood vessel to assist the blood transportation in the heart or the blood vessel; the structure of the pump part can be a fixed-diameter pump structure or a variable-diameter expandable pump structure; the power source part can be positioned in vivo or in vitro. When the power source part is positioned in the body, the power source part penetrates through the human body through a long lead and is connected to an external controller, a sheath tube is surrounded outside the long lead, and a main channel 11 of the double-channel sheath tube is arranged at the near-end position around the sheath tube; when the power source part is located extracorporeally, the pump part passes through the power source part outside the human body connector through the flexible driving shaft, the sheath that the catheter itself has is surrounded to the outside of the flexible driving shaft, and the main channel 11 of the double-channel sheath is arranged at the near-end position around the sheath.

When the blood pumping catheter enters a human body through the skin, in order to prevent blood from seeping out of the second cavity, the second cavity needs to be blocked by the blocking wire 2. Specifically, the outer diameter of the distal end of the blocking wire 2 is slightly larger than the inner diameter of the distal end of the second cavity, so that the distal end of the blocking wire 2 is in interference fit with the distal end of the second cavity to block the distal end port of the secondary channel 12; to avoid blood entering the second chamber. The plugging wire 2 and the second cavity are in clearance fit at the rest parts except the far-end port, namely the inner diameter of most of the second cavities is larger than the outer diameter of the plugging wire 2, and only at the position of the far-end port part of the second cavity, the inner diameter of the far end of the second cavity is smaller than the outer diameter of the far end of the plugging wire 2. The guidewire is sized slightly smaller than the inner diameter of the second lumen such that the guidewire can pass through the distal port into the blood vessel.

Preferably, the main channel 11 is provided with an exhaust duct 13 communicating with the first chamber. The exhaust pipe 13 is communicated with the first cavity and can be used for injecting perfusate such as glucose, physiological saline and the like to exhaust air in the first cavity, so that blood is prevented from entering the first cavity.

Specifically, the proximal end of the main channel 11 is connected with the main channel sheath cap 4, and a seal is arranged at the joint of the main channel 11 and the main channel sheath cap 4. The sealing member includes first sealing silica gel circle 5 and the second sealing silica gel circle 6 that sets gradually. The main channel sheath cap 4, the first sealing silica gel ring 5 and the second sealing silica gel ring 6 ensure the sealing of the near end of the main channel 11 when the blood pumping catheter 7 passes through the main channel sheath cap 4, the first sealing silica gel ring 5 and the second sealing silica gel ring 6 to enter the first cavity, so that the blood is prevented from flowing out.

Referring to fig. 3 and 4, in the double-channel sheath according to the embodiment of the present invention, the hemostatic valve 3 includes a housing 31 and a flexible membrane 32, the housing 31 is connected to the proximal end of the secondary channel 12 through a locking structure, and the flexible membrane 32 is disposed at the top end of the housing 31; the flexible membrane 32 blocks the proximal end port of the secondary channel 12, and the blocking wire 2 passes through the flexible membrane 32 to enter the second cavity to block the second cavity. The plugging wire 2 and the hemostatic valve 3 are arranged in a split mode, the plugging wire 2 can be directly pulled out from the hemostatic valve 3 in the operation process, the guide wire can directly penetrate from the hemostatic valve 3, and less bleeding or even no bleeding can be achieved.

Referring to fig. 5, in the double-channel sheath according to the embodiment of the present invention, the flexible film 32 is provided with the weakened area 33, so that the blocking wire 2 passes through the weakened area 33 of the flexible film 32 to enter the second lumen and block the second lumen.

Referring to fig. 6, in the double-channel sheath according to the embodiment of the present invention, the locking structure includes a female luer 34 disposed on the housing 31 and a male luer 14 disposed at the proximal end of the secondary channel 12, and the female luer 34 is screwed or snapped with the male luer 14.

In one embodiment, the locking structure is a snap lock, a female snap is arranged on the inner wall of the female luer 34, a male snap is arranged on the outer wall of the male luer 14, and the male luer 14 and the female luer 34 are connected and sealed through the snap. The flexible film 32 is a sealing silicon sheet 35, and the sealing silicon sheet 35 is bonded, welded or in interference connection with the shell 31.

Referring to fig. 7 and 8, in the double-channel sheath according to the embodiment of the present invention, the outer wall of the sheath body 1 is provided with the suture pad 9, the suture pad 9 is provided with the fixing sleeve, and the fixing sleeve is arranged around the outer wall of the sheath body 1; the suture pad 9 is fixed on the outer wall of the sheath tube body 1 through a fixing sleeve, and a suture fixing hole 94 is formed in the suture pad 9. The suture mat 9 is used to suture the skin to fix the sheath body 1.

Preferably, the locking sleeve of the suture mat 9 includes a constant diameter section 91, the constant diameter section 91 extending distally to form a variable diameter section 93, the diameter of the variable diameter section 93 gradually decreasing from the proximal end to the distal end. When the variable diameter section 93 enters a human blood vessel from the distal end, the blood vessel incision can be sealed because the diameter of the distal end is smaller than that of the proximal end.

The retaining sleeve is further provided with a limiting ring 92 for indicating the depth of the blood vessel, the limiting ring 92 is usually arranged on the fixed diameter section 91, and can be arranged at the joint of the fixed diameter section 91 and the variable diameter section 93 to limit the insertion distance of the retaining sleeve and block the retaining sleeve from being further inserted.

In other application scenarios, the fixing sleeve of the suture mat 9 may also only include the variable diameter section, the expansion of the outer diameter of the sheath body is achieved by using the variable diameter section, and the size of the expanded outer diameter and the length of the variable diameter section are selected according to actual needs, and are not limited herein.

The two-channel sheath tube provided by the embodiment of the utility model has the following practical working process: firstly, a female luer connector 34 and a male luer connector 14 are locked in a spiral mode, a plugging wire 2 is inserted into a sealing silica gel sheet 35 in advance, and the outer diameter of the far end of the plugging wire 2 is an interference size slightly larger than the inner diameter of the far end of a second cavity, so that the second cavity is plugged by the plugging wire 2; then the sheath tube body 1 is inserted into a human blood vessel and is sutured on the skin of the human body by utilizing the suture mat, so that the sheath tube body 1 is fixed. At the moment, the female luer connector 34 and the male luer connector 14 are locked and sealed in a spiral mode and are matched with the blocking thread 2 to block the auxiliary channel 12 of the sheath tube body 1, so that blood cannot flow out of a human body from the auxiliary channel 12 of the sheath tube body 1; in the operation process, if a new blood pumping catheter needs to be introduced, the guide wire needs to be reserved in a blood vessel of a human body after entering the human body from the auxiliary channel 12 of the sheath tube body 1, before the blood pumping catheter, the plugging wire 2 is firstly pulled out from the sealing silica gel sheet 35, the guide wire passes through the auxiliary channel 12 from the sealing silica gel sheet 35 and enters the blood vessel of the human body, and due to the existence of the sealing silica gel sheet 35, blood cannot flow out from the auxiliary channel 12.

In some application scenes, invasive pressure monitoring needs to be carried out through the second cavity in the operation process, the plugging wire 2 and the hemostatic valve 3 need to be pulled out from the second cavity, the pressure monitoring pipeline structure is connected with the near-end port of the second cavity, and in the pressure monitoring process, blood in the second cavity can be in an approximate static state in the cavity for a long time, so that thrombus is formed. After having the invasive pressure monitoring, if need pass through the second chamber with the seal wire and get into human blood vessel, remove the back with pressure monitoring pipeline structure, with 3 quick seal second cavitys of hemostasis valve, the shutoff silk 2 has removed from hemostasis valve 3 this moment, utilizes needle tubing puncture hemostasis valve 3 to pour into the second cavity with the thrombolysis material into, with the thrombus dissolve the back, can insert the blood vessel with shutoff silk 2 or seal wire again to can avoid directly bringing the thrombus into the blood vessel and arouse the risk.

In summary, in the double-channel sheath tube according to the embodiment of the present invention, the hemostatic valve 3 is disposed at the proximal end of the auxiliary channel 12, so that the blocking wire 2 of the second lumen and the hemostatic valve 3 can be separately sealed, bleeding is reduced when a guide wire is replaced or pressure measurement is performed, and the bleeding risk is reduced; after pressure measurement is carried out, thrombolytic substances can be injected into the second cavity through the sealing structure on the hemostatic valve 3, and the thrombus risk caused by directly inserting the plugging wire 2 or the guide wire into the blood vessel is avoided.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the utility model as defined by the appended claims.

Claims

1. A double-channel sheath tube is characterized by comprising a sheath tube body, wherein the sheath tube body is provided with a main channel and an auxiliary channel, and the main channel is provided with a first cavity allowing a blood pumping catheter to pass through; the auxiliary channel is provided with a second cavity, a blocking wire is arranged in the second cavity, one end of the blocking wire blocks a far-end port of the auxiliary channel, the other end of the blocking wire penetrates out of the hemostasis valve, the hemostasis valve is arranged at the near end of the auxiliary channel, and the hemostasis valve blocks a near-end port of the auxiliary channel.

2. The dual-channel sheath of claim 1, wherein the hemostasis valve comprises a housing connected to the proximal end of the secondary channel by a locking structure, and a flexible membrane disposed at a top end of the housing; the flexible membrane blocks the near-end port of the auxiliary channel, and the blocking wire penetrates through the flexible membrane and enters the second cavity.

3. The dual-channel sheath of claim 2, wherein the flexible membrane is provided with a weakened area, the blocking wire passing through the weakened area of the flexible membrane into the second lumen.

4. The dual-channel sheath according to claim 2, wherein the locking structure comprises a female luer provided on the housing and a male luer provided at a proximal end of the secondary channel, the female luer being screw-locked or snap-locked to the male luer.

5. The dual-channel sheath according to claim 2, wherein the flexible membrane is a sheet of silicone sealant bonded, welded, or interference-bonded to the housing.

6. The dual-channel sheath of claim 1, wherein the main channel is provided with an exhaust pipe communicating with the first cavity.

7. The dual channel sheath of claim 1, wherein a main channel sheath cap is attached to the proximal end of the main channel, and a seal is provided at the junction of the main channel and the main channel sheath cap.

8. The dual-channel sheath according to claim 7, wherein the sealing member includes a first silicone sealing ring and a second silicone sealing ring disposed in sequence.

9. The dual-channel sheath of claim 1, wherein an outer diameter of the distal end of the blocking wire is slightly larger than an inner diameter of the distal end of the second lumen, such that interference fit of the distal end of the blocking wire with the distal end of the second lumen effects blocking of the distal port of the secondary channel.

10. The dual-channel sheath according to claim 1, wherein the outer wall of the sheath body is provided with a suture pad, the suture pad is provided with a fixing sleeve, the fixing sleeve is arranged around the outer wall of the sheath body, the suture pad is fixed on the outer wall of the sheath body through the fixing sleeve, and a suture fixing hole is formed in the suture pad.

11. The dual-channel sheath of claim 10, wherein the anchor sleeve of the suture mat includes a constant diameter section extending distally to form a variable diameter section that gradually decreases in diameter from a proximal end to a distal end.