ECMO distal perfusion puncture system and method of use

Abstract

The ECMO distal perfusion puncture system provided by this invention includes a guidewire, an inner core, a cannula, and a distal perfusion cannula. Both the inner core and the cannula are cylindrical. The inner core is fitted inside the cannula, and a puncture guide hole is provided at the outer end of the cannula. The guidewire is fitted inside the inner core, with one end of the inner core gradually contracting to form a conical head. One end of the guidewire extends beyond the conical head to form the insertion end, and the other end extends beyond the inner core to form the traction end. One end of the distal perfusion cannula is extended to form a connecting male connector, which can be directly connected to the ECMO femoral artery cannula side port. This invention utilizes a successfully punctured femoral artery to accurately locate the distal end of the femoral artery, and inserts the distal guidewire before inserting the proximal perfusion cannula of the femoral artery, avoiding tubing interference, improving the puncture success rate, and reducing puncture time.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an ECMO distal perfusion cannula puncture device and its method of use. Background Technology

[0002] ECMO is a temporary support device for patients with circulatory and / or respiratory failure. Femoral artery and vein cannulation is the most common cannulation method for VA-ECMO. However, femoral artery cannulation can easily cause lower limb arterial ischemia, seriously affecting the patient's health and causing complications with serious prognoses. Placing a distal ECMO perfusion cannula can prevent and treat lower limb ischemia caused by ECMO cannulation. Currently, the conventional ultrasound-guided puncture placement method is commonly used.

[0003] The following problems may occur during routine ultrasound-guided puncture:

[0004] First, since VA-ECMO assisted patients are all patients in shock due to various reasons, and their conditions are urgent, it takes a long time to puncture the proximal and distal femoral arteries using ultrasound guidance.

[0005] Secondly, VA-ECMO assisted patients are all patients in shock due to various reasons, with significantly reduced femoral artery blood flow and vasoconstriction, which is especially obvious during ECPR. Currently, it is routine to first place the ECMO femoral artery perfusion cannula and then place the distal perfusion cannula after the ECMO machine is switched on. At this time, the femoral artery blood flow is significantly reduced, and due to the interference of the existing tubing, the routine ultrasound-guided puncture is difficult and time-consuming.

[0006] Third, there is currently no dedicated distal perfusion catheter. The CVC catheters, femoral artery sheaths, and pressure extension tubes currently in use all have certain problems. For example, due to incompatible connectors, double male extension tubes are required, and right angles in the sheaths can increase the risk of thrombosis. Furthermore, the perfusion flow rate cannot be adjusted, which poses risks such as over-perfusion. Summary of the Invention

[0007] The purpose of this invention is to provide an ECMO distal perfusion puncture device and its usage method that can control the distal perfusion flow, has a high puncture success rate, and a short puncture time.

[0008] To achieve the above objectives, the technical solution provided by this invention is as follows: an ECMO distal perfusion puncture system, comprising a distal perfusion tube, a guidewire, an inner core, and a sheath, wherein the inner core and the sheath are both cylindrical, the inner core is fitted inside the sheath, a one-way valve is provided inside the sheath, a puncture guide hole is provided at the outer end of the sheath, the sheath opening on one side of the puncture guide hole forms a guidewire groove, the outer end of the guidewire groove passes through the sheath, the inner end of the guidewire groove is connected to the puncture guide hole, the guidewire is fitted inside the inner core, one end of the inner core gradually contracts to form a conical head, one end of the guidewire extends out of the conical head to form an insertion end, the end of the insertion end is bent to form an anti-puncture bend, and the other end of the guidewire extends out of the inner core to form a traction end.

[0009] One end of the distal infusion tube is extended to form a connecting ring. The infusion tube is provided with a flow regulating slider and a through hole. The through hole fits into the infusion tube. The flow regulating slider on one side of the through hole is provided with an regulating hole. An regulating handle is engaged in the regulating hole. The inner end of the regulating handle contacts the infusion tube in the through hole.

[0010] The tube hole is equipped with a pressure block, the inner end of the adjusting handle is connected to the outer side of the pressure block, the inner side of the pressure block is arc-shaped, and its outer arc surface is in contact with the injection tube.

[0011] A puncture method for the ECMO distal perfusion puncture system according to claim 1, comprising the following steps:

[0012] 1) Under ultrasound guidance, the proximal femoral artery was punctured using standard methods, and a guidewire was placed.

[0013] 2) Under the guidance of the guidewire, insert the inner end of the inner core cannula assembly into the proximal femoral artery and adjust the insertion depth so that the puncture guide hole is close to the skin.

[0014] 3) Pull the guidewire and inner core outward to withdraw the guidewire and inner core from the proximal femoral artery, leaving the cannula in the proximal femoral artery to form a puncture channel;

[0015] 4) Rotate the cannula so that the plane formed by the long axis of the puncture guide hole and the long axis of the cannula is perpendicular to the skin surface, and make the puncture plane coincide with the plane where the femoral artery is located;

[0016] 5) Insert the puncture needle through the puncture guide hole. Stop advancing the needle when blood returns, so that the inner end of the puncture needle enters the distal femoral artery.

[0017] 6) Insert the insertion end of the distal guidewire of the femoral artery along the puncture needle into the distal femoral artery, and then withdraw the puncture needle;

[0018] 7) Displace the distal guidewire of the femoral artery in the direction of the guidewire groove, so that the distal guidewire of the femoral artery is removed from the cannula and left in the distal femoral artery.

[0019] 8) Replace the inner core into the cannula, insert the proximal femoral artery guidewire into the proximal femoral artery along the direction of the inner core, and then pull the cannula and inner core outward, leaving the proximal femoral artery guidewire in the proximal femoral artery, so that the proximal and distal femoral artery punctures are completed.

[0020] 9) Insert the ECMO femoral artery cannula into the proximal femoral artery along the guidewire. After turning the machine, connect the distal perfusion cannula to the lateral opening of the femoral artery cannula, and insert the distal perfusion cannula into the distal femoral artery along the guidewire.

[0021] 10) Perfusion can be performed by attaching a flow regulator to the distal perfusion cannula near the femoral artery.

[0022] This invention, employing the aforementioned scheme, accurately locates the distal end of the femoral artery using a successfully punctured femoral artery. A distal guidewire is inserted before the proximal femoral artery perfusion cannula is inserted, avoiding tubing interference and preventing reduced blood flow after ECMO femoral artery cannula insertion, thus improving puncture success rate and reducing puncture time. One end of the distal perfusion cannula is extended to form a male connector, allowing direct connection to the ECMO femoral artery cannula side port. An adjustable perfusion flow device is installed on the distal perfusion cannula to control the distal perfusion flow and prevent over-perfusion. The pressurization device features an arc-shaped design to reduce tubing damage and prevent blood flow turbulence. The distal perfusion cannula can be directly connected to the proximal femoral artery perfusion cannula side port, avoiding risks such as additional connectors, extension tubes, and right-angle blood flow. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the guide wire, inner core, and sleeve of the present invention.

[0024] Figure 2 This is a schematic diagram of the sleeve structure of the present invention.

[0025] Figure 3 This is a schematic diagram illustrating the principle of puncturing the proximal femoral artery under ultrasound guidance using the conventional method of this invention.

[0026] Figure 4 This is a schematic diagram illustrating the principle of inserting the inner core and cannula into the proximal femoral artery according to the present invention.

[0027] Figure 5 This is a schematic diagram illustrating the principle of distal femoral artery guidewire insertion according to the present invention.

[0028] Figure 6 This is a schematic diagram illustrating the insertion principle of the proximal femoral artery guidewire according to the present invention.

[0029] Figure 7 This is a schematic diagram of the guidewire left after the proximal and distal femoral artery punctures of the present invention.

[0030] Figure 8 This is a schematic diagram of the injection tube of the present invention.

[0031] Figure 9 This is a diagram of the internal structure of the flow regulating slider of the present invention.

[0032] Figure 10 This is a schematic diagram of the tube hole inside the flow regulating slider of the present invention. Detailed Implementation

[0033] The present invention will be further described below with reference to all accompanying drawings. A preferred embodiment of the present invention is as follows: (See attached drawings) Figure 1 To be continued Figure 10The ECMO distal perfusion puncture system described in this embodiment includes a distal perfusion tube 4, a guidewire 1, an inner core 2, and a cannula 3. The inner core 2 and the cannula 3 are both cylindrical. The inner core 2 is fitted inside the cannula 3. The cannula 3 is equipped with a one-way valve 11, which is a valve structure used to prevent blood from flowing out during puncture. The outer end of the cannula 3 is provided with a puncture guide hole 12. One side of the cannula 3 opening of the puncture guide hole 12 forms a guidewire groove 13. The outer end of the guidewire groove 13 passes through the cannula 3, and the inner end of the guidewire groove 13 is connected to the puncture guide hole 12. The guidewire 1 is fitted inside the inner core 2. One end of the inner core 2 gradually contracts to form a conical head. One end of the guidewire 1 extends out of the conical head to form an insertion end. The end of the insertion end is bent to form an anti-puncture bend 14. The other end of the guidewire 1 extends out of the inner core 2 to form a traction end.

[0034] One end of the distal infusion tube 4 is extended to form a connecting ring 5. The infusion tube 4 is provided with a flow regulating slider 6, and the flow regulating slider 6 is provided with a through tube hole 8. The tube hole 8 fits into the infusion tube 4. One side of the flow regulating slider 6 of the tube hole 8 is provided with an regulating hole. An regulating handle 7 is engaged in the regulating hole. The inner end of the regulating handle 7 contacts the infusion tube 4 in the tube hole 8. A pressure block 9 is provided in the tube hole 8. The inner end of the regulating handle 7 is connected to the outer side of the pressure block 9. The inner side of the pressure block 9 is arc-shaped, and its outer arc surface contacts the infusion tube 4.

[0035] The puncture method for the above-mentioned ECMO distal perfusion puncture system includes the following steps:

[0036] 1) Under ultrasound guidance, the proximal femoral artery was punctured using standard methods, and a guidewire was placed.

[0037] 2) Under the guidance of the guidewire, insert the inner end of the inner core cannula assembly into the proximal femoral artery and adjust the insertion depth so that the puncture guide hole is close to the skin.

[0038] 3) Pull the guidewire and inner core outward to withdraw the guidewire and inner core from the proximal femoral artery, leaving the cannula in the proximal femoral artery to form a puncture channel;

[0039] 4) Rotate the cannula so that the plane formed by the long axis of the puncture guide hole and the long axis of the cannula is perpendicular to the skin surface, and make the puncture plane coincide with the plane where the femoral artery is located;

[0040] 5) Insert the puncture needle through the puncture guide hole. Stop advancing the needle when blood returns, so that the inner end of the puncture needle enters the distal femoral artery.

[0041] 6) Insert the insertion end of the distal guidewire of the femoral artery along the puncture needle into the distal femoral artery, and then withdraw the puncture needle;

[0042] 7) Displace the distal guidewire of the femoral artery in the direction of the guidewire groove, so that the distal guidewire of the femoral artery is removed from the cannula and left in the distal femoral artery.

[0043] 8) Replace the inner core into the cannula, insert the proximal femoral artery guidewire into the proximal femoral artery along the direction of the inner core, and then pull the cannula and inner core outward, leaving the proximal femoral artery guidewire in the proximal femoral artery, so that the proximal and distal femoral artery punctures are completed.

[0044] 9) Insert the ECMO femoral artery cannula into the proximal femoral artery along the guidewire. After turning the machine, connect the distal perfusion cannula to the lateral opening of the femoral artery cannula, and insert the distal perfusion cannula into the distal femoral artery along the guidewire.

[0045] 10) Perfusion can be performed by attaching a flow regulator to the distal perfusion cannula near the femoral artery.

[0046] The technical advantages of this invention are:

[0047] 1. Accurately locate the distal end of the femoral artery using the successfully punctured femoral artery, and insert the distal guidewire before inserting the proximal perfusion cannula of the femoral artery to avoid tubing interference, avoid reduced blood flow after ECMO femoral artery cannulation, improve puncture success rate, and reduce puncture time.

[0048] 2. The distal end of the male perfusion cannula can be directly connected to the ECMO femoral artery cannula side hole, avoiding the risk factors of adding connectors, adding extension tubes, and right-angle blood flow;

[0049] 3. A flow regulating device is installed on the outside of the distal infusion tube to control the distal infusion flow and avoid over-infusion; the pressurizing device adopts an arc-shaped design to reduce pipe damage and avoid blood flow disturbance.

[0050] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Therefore, any changes made in accordance with the shape and principle of the present invention should be covered within the protection scope of the present invention.

Claims

1. An ECMO distal perfusion puncture system, characterized in that: It includes a distal infusion tube (4), a guidewire (1), an inner core (2), and a cannula (3). The inner core (2) and the cannula (3) are both cylindrical. The inner core (2) is fitted inside the cannula (3). A one-way valve (11) is provided inside the cannula (3). A puncture guide hole (12) is provided at the outer end of the cannula (3). The cannula (3) on one side of the puncture guide hole (12) forms a guidewire groove (13). The outer end of the guidewire groove (13) passes through the cannula (3). The inner end of the guidewire groove (13) is connected to the puncture guide hole (12). The guidewire (1) is fitted inside the inner core (2). One end of the inner core (2) gradually contracts to form a conical head. One end of the guidewire (1) extends out of the conical head to form an insertion end. The end of the insertion end is bent to form a... The anti-stab elbow (14) has the other end of the guide wire (1) extending out of the inner core (2) to form a traction end; one end of the distal injection tube (4) is extended to form a connecting ring (5), and the injection tube (4) is provided with a flow regulating slider (6), and the flow regulating slider (6) is provided with a through-hole (8), the hole (8) is fitted with the injection tube (4), and the flow regulating slider (6) on one side of the hole (8) is provided with an adjusting hole, and an adjusting handle (7) is engaged in the adjusting hole, and the inner end of the adjusting handle (7) is in contact with the injection tube (4) in the hole (8); a pressure block (9) is provided in the hole (8), and the inner end of the adjusting handle (7) is connected to the outer side of the pressure block (9), the inner side of the pressure block (9) is arc-shaped, and its outer arc surface is in contact with the injection tube (4); The puncture method using the ECMO distal perfusion puncture system includes the following steps: 1) Under ultrasound guidance, the proximal femoral artery was punctured using standard methods, and a guidewire was placed. 2) Under the guidance of the guidewire, insert the inner end of the inner core cannula assembly into the proximal femoral artery and adjust the insertion depth so that the puncture guide hole is close to the skin. 3) Pull the guidewire and inner core outward to withdraw the guidewire and inner core from the proximal femoral artery, leaving the cannula in the proximal femoral artery to form a puncture channel; 4) Rotate the cannula so that the plane formed by the long axis of the puncture guide hole and the long axis of the cannula is perpendicular to the skin surface, and make the puncture plane coincide with the plane where the femoral artery is located; 5) Insert the puncture needle through the puncture guide hole. Stop advancing the needle when blood returns, so that the inner end of the puncture needle enters the distal femoral artery. 6) Insert the insertion end of the distal guidewire of the femoral artery along the puncture needle into the distal femoral artery, and then withdraw the puncture needle; 7) Displace the distal guidewire of the femoral artery in the direction of the guidewire groove, so that the distal guidewire of the femoral artery is removed from the cannula and left in the distal femoral artery. 8) Replace the inner core into the cannula, insert the proximal femoral artery guidewire into the proximal femoral artery along the direction of the inner core, and then pull the cannula and inner core outward, leaving the proximal femoral artery guidewire in the proximal femoral artery, so that the proximal and distal femoral artery punctures are completed. 9) Insert the ECMO femoral artery cannula into the proximal femoral artery along the guidewire. After turning the machine, connect the distal perfusion cannula to the lateral opening of the femoral artery cannula, and insert the distal perfusion cannula into the distal femoral artery along the guidewire. 10) Perfusion can be performed by attaching a flow regulator to the distal perfusion cannula near the femoral artery.

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