ECMO distal perfusion device and methods of use thereof

Abstract

The ECMO distal perfusion device and the use method thereof provided by the present disclosure relate to the technical field of medical devices, and comprise a first pipeline, a second pipeline, an extension pipe, a three-way pipe and an adjusting cap. The first end and the second end of the three-way pipe are connected to the loop of an ECMO arterial cannula, the third end of the three-way pipe is communicated with one end of the extension pipe, the other end of the extension pipe is communicated with the first pipeline, the end of the first pipeline away from the extension pipe is provided with the adjusting cap, the adjusting cap is communicated with the second pipeline arranged in the adjusting cap, the perfusion flow from the first pipeline to the second pipeline can be adjusted by the adjusting cap, the other end of the second pipeline is communicated with a distal artery, a sheath tube and a guide wire in the second pipeline can pass through, and a closable opening arranged at the communication position of the adjusting cap and the second pipeline is removed. The device can ensure sufficient perfusion flow and control the flow, and the adjusting cap and the closable opening can protect the second pipeline.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to an ECMO distal perfusion device and its usage method. 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 potentially causing serious prognostic complications. Placing a distal ECMO perfusion cannula can prevent and treat lower limb ischemia caused by ECMO cannulation, but currently there is no dedicated ECMO distal perfusion cannula; instead, a temporary arterial sheath is used.

[0003] The following problems may arise when using arterial sheaths as distal perfusion catheters:

[0004] 1. If the flow rate is too low, it cannot meet the requirement of complete perfusion of the lower limbs, resulting in the incomplete correction of lower limb ischemia;

[0005] 2. When the patient's condition improves, the infusion rate cannot be adjusted, which may lead to tissue over-perfusion and damage caused by the production of oxygen free radicals later on;

[0006] 3. Only suitable for short-term temporary installation. If the installation time exceeds 24 hours, it is prone to cracking and bleeding, which may cause serious consequences. Summary of the Invention

[0007] To address the aforementioned technical issues, this disclosure provides an ECMO remote perfusion device and its usage method.

[0008] This disclosure provides an ECMO distal perfusion device, including a first tubing, a second tubing, an extension tubing, a tee tubing, and an adjustment cap;

[0009] The first and second ends of the three-way connector are used to connect to the ECMO arterial cannula loop; the third end of the three-way connector is connected to one end of the extension tube, and the other end of the extension tube is connected to the first tubing. An adjustment cap is provided at the end of the first tubing away from the extension tube. One end of the second tubing is placed inside the adjustment cap and is connected to the first tubing. The adjustment cap is used to adjust the perfusion flow from the first tubing to the second tubing. The other end of the second tubing is connected to the distal artery. A sheath and guidewire are placed inside the second tubing. A closable opening is provided at the connection between the adjustment cap and the second tubing for the sheath and guidewire to pass through.

[0010] Optionally, the adjusting cap has a columnar structure, and the first pipeline is connected to the curved wall of the adjusting cap.

[0011] Optionally, the adjusting cap is coaxially positioned with the end of the second pipeline near the adjusting cap.

[0012] Optionally, a flow-limiting section is provided at the connection between the regulating cap and the first pipeline, and the flow-limiting section is used to block the port of the first pipeline.

[0013] Optionally, the adjusting cap can rotate relative to the first pipeline.

[0014] Optionally, the flow-limiting part is a trapezoidal structure, used to change the area of ​​the port of the first pipeline blocked by the flow-limiting part when the regulating cap rotates relative to the first pipeline.

[0015] Optionally, the flow restrictor includes multiple openings of different areas. When the regulating cap rotates relative to the first pipeline, the first pipeline connects with the openings of different areas to control the injection flow rate at the port of the first pipeline.

[0016] Optionally, a port may be provided on the first conduit.

[0017] Optionally, the adjustment cap may be provided with a fixing protrusion for securing the adjustment cap to the skin.

[0018] This disclosure also provides a method for using an ECMO distal perfusion device, including the following steps:

[0019] Puncture the distal artery of the VA artery, insert a guidewire, sheath, and second line;

[0020] An adjusting cap is installed at the end of the second pipeline, and the sheath is removed;

[0021] Cut the loop at the ECMO arterial cannula and connect it to the first and second ends of the three-way cannula;

[0022] An extension pipe is installed at the third end of the tee pipe;

[0023] Connect the first pipe with the extension tube set on the adjusting cap;

[0024] The perfusion flow rate from the first tubing to the second tubing is adjusted using an adjusting cap according to the patient's perfusion needs.

[0025] The technical solution provided in this disclosure has the following advantages compared with the prior art:

[0026] By connecting the first and second ends of a three-way stopcock to the ECMO arterial cannula loop, and connecting the third end of the three-way stopcock to one end of an extension tube, and the other end of the extension tube to a first tubing, an adjustment cap is installed at the end of the first tubing furthest from the extension tube. This adjustment cap connects to a second tubing, one end of which is located within the adjustment cap. The adjustment cap allows for regulation of the perfusion flow from the first to the second tubing. The other end of the second tubing connects to a distal artery, allowing the sheath and guidewire within the second tubing to pass through. The sealable opening at the connection between the adjustment cap and the second tubing can be removed. This device allows for direct drainage of blood from the ECMO arterial cannula loop via the three-way stopcock, ensuring sufficient perfusion flow. The adjustment cap controls the perfusion flow, and the adjustment cap and sealable opening protect the second tubing, preventing its end from cracking after repeated disinfection. This reduces the risk of infection and avoids serious bleeding and complications for the patient. Attached Figure Description

[0027] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0028] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the ECMO distal perfusion device described in an embodiment of this disclosure;

[0030] Figure 2 This is a front view of the connection between the first pipeline and the regulating cap in an embodiment of this disclosure;

[0031] Figure 3 This is a bottom view of the connection between the first pipeline and the regulating cap in an embodiment of this disclosure;

[0032] Figure 4 This is a schematic diagram showing the connection relationship between the flow-limiting part of the trapezoidal structure and the second pipeline according to an embodiment of this disclosure;

[0033] Figure 5 This is a schematic diagram of the three-way pipe described in an embodiment of this disclosure;

[0034] Figure 6 This is a schematic diagram of the protective cover described in an embodiment of this disclosure;

[0035] Figure 7 This is a schematic diagram of the guidewire described in an embodiment of this disclosure;

[0036] Figure 8 This is a schematic diagram of the puncture needle described in an embodiment of this disclosure;

[0037] Figure 9 This is a schematic diagram of the loop for ECMO arterial cannulation according to an embodiment of this disclosure;

[0038] Figure 10 This is a schematic diagram of the loop for connecting the three-way cannula to the ECMO arterial cannula according to an embodiment of this disclosure;

[0039] Figure 11 This is a schematic diagram of the installation process of the ECMO remote infusion device described in the embodiments of this disclosure;

[0040] Figure 12 This is a schematic diagram showing the connection relationship between the flow-limiting part, which includes an adjusting cap with multiple openings, and the second pipeline, as described in an embodiment of this disclosure.

[0041] Among them, 1. First tubing; 2. Second tubing; 3. Three-way valve; 4. Adjustment cap; 5. Sheath; 6. Guide wire; 7. Puncture needle; 8. Intravenous cannula; 9. Centrifugal pump; 10. Oxygenator; 11. Arterial cannula; A. Skin; B. Artery. Detailed Implementation

[0042] To better understand the above-mentioned objectives, features, and advantages of this disclosure, the solutions disclosed herein will be further described below. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0043] Numerous specific details are set forth in the following description in order to provide a full understanding of this disclosure, but this disclosure may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only some, and not all, of the embodiments of this disclosure.

[0044] Combination Figure 1 and Figure 11 As shown, this disclosure provides an ECMO distal perfusion device, including a first tubing 1, a second tubing 2, an extension tube, a three-way connector 3, and an adjustment cap 4; the first and second ends of the three-way connector 3 are used to connect to the loop of the ECMO arterial cannula; the third end of the three-way connector 3 is connected to one end of the extension tube, and the other end of the extension tube is connected to the first tubing 1; the end of the first tubing 1 away from the extension tube is provided with an adjustment cap 4; one end of the second tubing 2 is disposed in the adjustment cap 4 and is connected to the first tubing 1; the adjustment cap 4 is used to adjust the perfusion flow from the first tubing 1 to the second tubing 2; the other end of the second tubing 2 is connected to the distal artery; a sheath 5 and a guidewire 6 are disposed in the second tubing 2; and a closable opening is provided at the connection between the adjustment cap 4 and the second tubing 2 for the sheath 5 and the guidewire 6 to pass through.

[0045] Combination Figures 6 to 10As shown, preferably, the adjusting cap 4 has a removable protective cap at the open end for sealing the opening after the sheath 5 and guidewire 6 are removed; in some embodiments, a protective plug may also be provided for sealing the opening. Specifically, the diameters of the first and second ends of the three-way tube 3 are equal, and the diameter of the third end is smaller than the diameters of the first and second ends. More specifically, the loop at the ECMO arterial cannula end includes at least a venous cannula 8, a centrifugal pump 9, an oxygenator 10, and an arterial cannula 11.

[0046] In the aforementioned ECMO distal perfusion device, by connecting the first and second ends of the three-way tube 3 to the loop of the ECMO arterial cannula, and connecting the third end of the three-way tube 3 to one end of the first tubing 1, blood in the loop is drained; by setting an adjustment cap 4 connected to the first tubing 1 at the other end of the first tubing 1, and the adjustment cap 4 simultaneously connected to the second tubing 2 with one end set inside the adjustment cap 4, the perfusion flow rate from the first tubing 1 to the second tubing 2 can be adjusted by the adjustment cap 4. The other end of the second tubing 2 is connected to the distal artery, and the sheath 5 and guidewire 6 inside the second tubing 2 can pass through. The closable opening set at the connection between the adjustment cap 4 and the second tubing 2 can be removed.

[0047] By setting up the above-mentioned ECMO distal perfusion device, blood in the ECMO arterial cannula can be directly drawn out through the three-way tube 3, ensuring sufficient perfusion flow. The flow can be controlled by the adjusting cap 4. The adjusting cap 4 and the sealable opening can protect the second tube 2, preventing the end of the second tube 2 from cracking after repeated disinfection. This reduces the risk of infection and avoids serious bleeding and complications for the patient.

[0048] Combination Figure 2 and Figure 3 As shown, in some embodiments, the regulating cap 4 is a columnar structure, and the first pipe 1 is connected to the curved wall of the regulating cap 4. More specifically, the first pipe 1 and the second pipe 2 are connected inside the regulating cap 4; the regulating cap 4 can both adjust the injection flow rate and serve as a connection structure between the first pipe 1 and the second pipe 2.

[0049] In some embodiments, the adjusting cap 4 and the end of the second pipe 2 near the adjusting cap 4 are coaxially arranged. Specifically, one flat end of the adjusting cap 4 is used to insert the second pipe 2, and the other flat end is used to provide a closable opening; the first pipe 1 and the second pipe 2 are connected on different surfaces of the adjusting cap 4, which can prevent the first pipe 1 and the second pipe 2 from interfering with or tangling with each other during connection operations or adjustment of the adjusting cap 4.

[0050] In some embodiments, a flow-limiting section is provided at the connection between the regulating cap 4 and the first pipeline 1. The flow-limiting section is used to block the port of the first pipeline 1. Specifically, the flow-limiting section restricts the injection flow rate by blocking the port of the first pipeline 1. When the flow-limiting section does not block the port of the first pipeline 1, the injection flow rate is at its maximum. The aforementioned flow-limiting section can avoid wear on the first pipeline 1 caused by the compressive flow-limiting method.

[0051] In some embodiments, the adjusting cap 4 rotates relative to the first conduit 1. More specifically, by rotating the adjusting cap 4, the blocking area of ​​the flow restrictor on the port of the first conduit 1 is adjusted, thereby regulating the injection flow rate.

[0052] like Figure 4 As shown, in some embodiments, the flow-limiting part is a trapezoidal structure, used to change the area of ​​the port of the first pipeline 1 blocked by the flow-limiting part when the regulating cap 4 rotates relative to the first pipeline 1. More specifically, when the regulating cap 4 rotates, the area of ​​the trapezoidal structure blocking the port of the first pipeline 1 changes, thereby achieving the regulation of the injection flow rate.

[0053] like Figure 12 As shown, in some embodiments, the flow-limiting part includes multiple openings of different areas. When the adjusting cap 4 rotates relative to the first pipe 1, the first pipe 1 connects with the openings of different areas to control the injection flow rate at the port of the first pipe 1. More specifically, when the opening with a smaller area is connected to the port of the first pipe 1, the injection flow rate is smaller, and when the opening with a larger area is connected to the port of the first pipe 1, the injection flow rate is larger; the above method can control the injection flow rate more precisely.

[0054] In some embodiments, the first conduit 1 is provided with a port. Preferably, the port is provided with a removable port cap. Specifically, the port is used to connect to a syringe to expel gas or blood clots from the first conduit 1 and the second conduit 2. After the above operation is completed, the port should be sealed in a timely manner by the port cap to protect the port portion.

[0055] In some embodiments, the adjusting cap 4 is provided with a fixing protrusion for fixing the adjusting cap 4 to the skin. Specifically, after the infusion flow rate is adjusted, the adjusting cap 4 can be fixed to the skin by means of adhesive, binding, suturing, etc., while fixing the first tubing 1 to prevent changes in the infusion flow rate caused by the relative uniqueness between the first tubing 1 and the adjusting cap 4. In some embodiments, the opening of the adjusting cap 4 is closed after it is fixed.

[0056] This disclosure also provides a method for using an ECMO distal perfusion device, including the following steps:

[0057] Puncture the VA artery and insert a cannula 11 distal to the artery, and set up guidewire 6, sheath 5 and second tubing 2;

[0058] An adjusting cap 4 is installed at the end of the second pipe 2, and the sheath 5 is removed;

[0059] Cut the loop at the ECMO arterial cannula and connect it to the first and second ends of the three-way cannula 3;

[0060] An extension pipe is installed at the third end of the tee pipe 3;

[0061] Connect the extension tube to the first pipe 1 set on the regulating cap 4;

[0062] According to the patient's perfusion needs, the perfusion flow rate from the first tubing 1 to the second tubing 2 is adjusted by adjusting the adjusting cap 4.

[0063] The above embodiment will be described below with reference to a specific usage process of an ECMO remote perfusion device:

[0064] First, after disinfecting the skin (A), the artery (B) distal to the VA artery cannula 11 is punctured using the puncture needle 7, and the guide wire 6, sheath 5, and second tubing 2 are set up; then, the assembled sheath 5, lumen, and adjusting cap are inserted through the guide wire 6, and the sheath 5 is removed; the first tubing 1 is connected to the adjusting cap 4, and air is vented; after the air is vented, a tubing clamp is set at the end of the first tubing 1 away from the adjusting cap 4 to clamp the first tubing 1.

[0065] Reduce the ECMO rotation speed to 1500 rpm, such as Figure 9 As shown, a tubing clamp is placed between the oxygenator 10 and the arterial cannula 11 to clamp the loop, with the two clamps 6-8 cm apart; then the ECMO speed is adjusted to 0, the loop at the ECMO arterial cannula end is cut, and a clamp is placed at the cut point as shown. Figure 5 The three-way tube 3 shown is connected to the first and second ends of the ECMO arterial cannula. After the air is vented through the third end of the three-way tube 3, the third end of the three-way tube 3 is connected to the extension tube.

[0066] Loosen the tubing clamps on the loop to release air, then seal the connection between the T-connector 3 and the extension tube; adjust the ECMO speed to 1500 rpm, loosen all the clamps, and increase the ECMO speed according to the patient's required flow rate; connect the extension tube to the first tubing 1 and release air through the connector; then rotate the adjusting cap 4 to adjust the perfusion flow rate, and finally fix the adjusting cap 4 to the skin and place the protective cap.

[0067] In the description of the embodiments of this disclosure, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "height", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the embodiments of this disclosure and simplifying the description, and are not intended to indicate or imply that the structure or device referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of this disclosure.

[0068] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0069] The above description is merely a specific embodiment of this disclosure, enabling those skilled in the art to understand or implement it. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An ECMO distal perfusion device, characterized in that, It includes a first pipe (1), a second pipe (2), an extension pipe, a tee pipe (3), and an adjusting cap (4); The first and second ends of the three-way tube (3) are used to connect to the loop of ECMO arterial cannulation; the third end of the three-way tube (3) is connected to one end of the extension tube, and the other end of the extension tube is connected to the first tube (1). An adjustment cap (4) is provided at the end of the first tube (1) away from the extension tube. One end of the second tube (2) is located inside the adjustment cap (4) and is connected to the first tube (1). The adjustment cap (4) is used to adjust the perfusion flow from the first tube (1) to the second tube (2). The other end of the second tube (2) is connected to the distal artery. A sheath (5) and a guidewire (6) are provided inside the second tube (2). A closable opening is provided at the connection between the adjustment cap (4) and the second tube (2) for the sheath (5) and the guidewire (6) to pass through. The adjusting cap (4) has a columnar structure, and the first pipeline (1) is connected to the curved wall of the adjusting cap (4); The adjusting cap (4) is coaxially arranged with the end of the second pipeline (2) near the adjusting cap (4); A flow-limiting section is provided at the connection between the regulating cap (4) and the first pipeline (1), and the flow-limiting section is used to block the port of the first pipeline (1).

2. The ECMO distal perfusion device according to claim 1, characterized in that, The adjusting cap (4) rotates relative to the first pipeline (1).

3. The ECMO distal perfusion device according to claim 2, characterized in that, The flow-limiting part has a trapezoidal structure and is used to change the area of ​​the port of the first pipeline (1) blocked by the flow-limiting part when the adjusting cap (4) rotates relative to the first pipeline (1).

4. The ECMO distal perfusion device according to claim 2, characterized in that, The flow limiting part includes multiple openings of different areas. When the adjusting cap (4) rotates relative to the first pipeline (1), the first pipeline (1) is connected to the openings of different areas to control the injection flow rate at the port of the first pipeline (1).

5. The ECMO distal perfusion device according to any one of claims 1 to 4, characterized in that, The first pipeline (1) is provided with a port.

6. The ECMO distal perfusion device according to any one of claims 1 to 4, characterized in that, The adjusting cap (4) is provided with a fixing protrusion, which is used to fix the adjusting cap (4) to the skin.

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