An ECMO distal perfusion catheter and method of implanting the same

Abstract

The present application relates to the technical field of medical devices, in particular to an ECMO distal perfusion catheter and an implantation method thereof, comprising a sheath pipe, one end of the sheath pipe is provided with a connecting head, a side branch hose is arranged on the connecting head, and a three-way valve is arranged at one end of the side branch hose away from the connecting head; the sheath pipe is in a tubular structure, a side hole area is arranged through the side wall of one end of the sheath pipe away from the connecting head, and the side hole area is used for supplying blood to a distal blood vessel of a patient. The technical scheme provided by the present application can effectively expand the blood supply coverage, improve the blood supply stability, and avoid local blood vessel ischemia by arranging a side hole area at the head of the sheath pipe and supplying blood to the distal blood vessel through multiple outlets.

Description

Technical Field

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

[0002] ECMO, as an important life support technology, plays a crucial role in the rescue and treatment of critically ill patients and is now widely used in clinical practice. During ECMO treatment, 18F catheters are usually used for arterial catheterization in adults. Due to their large diameter, these catheters can easily lead to complications such as distal vascular ischemia and necrosis. Therefore, an additional distal perfusion catheter is needed to address this issue.

[0003] In existing technologies, distal perfusion catheters typically use 5F or 6F arterial sheaths, implanted 2-5 cm distal to the ECMO catheter, with the insertion direction towards the distal end. However, this implantation method has two significant drawbacks: First, thrombi can easily form between the distal perfusion catheter and the ECMO catheter, potentially leading to severe adverse consequences such as lower limb ischemia and necrosis. The core reason is the blood flow competition between the two catheters, resulting in slow blood flow in that area and creating conditions conducive to thrombus formation. Second, this implantation method differs significantly from conventional puncture and catheter placement methods, involving a cumbersome procedure that causes considerable inconvenience for clinical medical staff, reduces surgical efficiency, and increases intraoperative risks.

[0004] In view of the shortcomings of the existing technologies, there is an urgent need to develop an ECMO distal perfusion catheter and corresponding implantation method that can reduce the risk of thrombosis and is easy to operate. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of existing ECMO distal perfusion catheters and implantation methods, such as high risk of thrombosis and inconvenient operation, and to provide a new ECMO distal perfusion catheter and its implantation method that has stable blood supply, low risk of thrombosis and convenient implantation.

[0006] This invention provides an ECMO distal perfusion catheter, including a sheath, a connector at one end of the sheath, a side branch hose at the connector, and a three-way valve at the end of the side branch hose away from the connector; the sheath is a tubular structure, and a side hole region is provided through the side wall at the end of the sheath away from the connector, the side hole region being used to supply blood to the patient's distal blood vessels.

[0007] Furthermore, the side hole area is provided with 4-6 through holes, and multiple through holes are located on the same side of the sheath, with adjacent through holes being staggered.

[0008] Furthermore, the spacing between two adjacent through holes is the same.

[0009] Furthermore, the diameter of the sheath is 7F.

[0010] Furthermore, development marks are provided on both sides of the side hole area, and the development marks are ring-shaped.

[0011] Furthermore, the sheath is made of stainless steel or polymer material.

[0012] Furthermore, the length of the side hole region is 1.5-2.5cm.

[0013] Furthermore, the diameter of the through hole is 0.8-1.2 mm.

[0014] Furthermore, a protective sleeve is provided on the outside of the sheath, and the protective sleeve is snapped into the connector.

[0015] The present invention also provides a method for implanting the distal perfusion catheter of the ECMO, comprising the following steps: S1. Determine the puncture and implantation site of the ECMO arterial catheter and perform puncture pretreatment, which includes skin disinfection and local anesthesia; S2. Arrange the sheath and ECMO arterial catheter in the same direction to ensure that the implantation direction of the sheath and ECMO arterial catheter is consistent; S3. Maintain a distance of 5-6 cm between the insertion port of the sheath and the insertion port of the ECMO arterial catheter, and perform puncture and implantation simultaneously; S4. Blood is supplied to the distal blood vessel through multiple through holes in the side hole area. Postoperatively, the blood flow and vital signs of the patient's distal blood vessel are monitored to complete the implantation procedure.

[0016] In summary, compared with the prior art, the present invention has the following advantages: The technical solution provided by the present invention provides a side hole area at the head of the sheath, and supplies blood to the patient's distal blood vessels through multiple outlets, which can effectively expand the blood supply coverage, improve blood supply stability, and avoid local blood vessel ischemia.

[0017] The ECMO distal perfusion catheter provided by this invention is implanted in the same direction as the ECMO arterial catheter at a distance of 5cm. This overcomes the problem of slow blood flow caused by blood flow competition between the two catheters in traditional catheter placement, significantly reducing the risk of thrombosis and thus reducing the occurrence of serious adverse consequences such as lower limb ischemia and necrosis. Attached Figure Description

[0018] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the ECMO distal perfusion catheter in an embodiment of the present invention; Figure 2 This is a partial enlarged view of the head end of the sheath in an embodiment of the present invention; Figure 3 This is a schematic diagram of the ECMO distal perfusion catheter with a protective sheath in an embodiment of the present invention; Figure 4 This is a schematic diagram illustrating the implantation method of a distal perfusion catheter in existing technologies. Figure 5 Photographs showcasing the clinical application of distal perfusion catheters in existing technologies; Figure 6 These are photos illustrating the clinical application of the ECMO distal perfusion catheter in this embodiment of the invention.

[0020] Explanation of reference numerals in the attached diagram: 1-Sheath; 101-Through hole; 102-Iconic marker; 2-Connector; 3-Side tube; 4-Three-way valve; 5-Protective sheath; 6-ECMO arterial catheter. Detailed Implementation

[0021] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0023] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified. Furthermore, the terms "installed," "connected," and "linked" should be interpreted broadly; for example, they may refer to a fixed connection, a detachable connection, or an integral connection; they may refer to a mechanical connection or an electrical connection; they may refer to a direct connection or an indirect connection through an intermediate medium; and they may refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0024] Example An ECMO distal perfusion catheter, such as Figure 1 As shown, it includes a sheath tube 1, a connector 2, a side branch hose 3, and a three-way valve 4, the details of which are as follows: Sheath 1 is a tubular structure made of biocompatible stainless steel or medical-grade polymer materials, which can reduce irritation and damage to the human body. The diameter of sheath 1 is 7F, which can ensure sufficient blood flow to meet the blood supply needs of distal blood vessels, while also having good flexibility and easy implantation, without increasing the difficulty of puncture or damaging blood vessels due to excessively large diameter.

[0025] One end of the sheath 1 is fixed with a connector 2, which is made of medical plastic. A side branch tube 3 is fixedly connected to the connector 2. The end of the side branch tube 3 away from the connector 2 is connected to a three-way valve 4. The three-way valve 4 is a standard medical three-way valve, which can realize the switching of the passage and the adjustment of the flow.

[0026] like Figure 2 As shown, the sheath 1 has a side hole region on the side wall away from the connector 2 (i.e., all through holes 101 in the side hole region are located on the same side of the central axis of the sheath 1). The length of the side hole region is 1.5-2.5 cm, and there are 6 through holes 101 in the side hole region. All 6 through holes 101 are located on the same side of the sheath 1, and adjacent through holes 101 are staggered. The spacing between adjacent through holes 101 is the same, and the diameter of the through holes 101 is 0.8-1.2 mm. The uniform spacing between adjacent through holes 101 optimizes the blood supply distribution and avoids local over- or under-supply of blood.

[0027] The sheath 1 has a contrast marker 102 at each end of the side hole area. The contrast marker 102 is ring-shaped. The contrast marker 102 is used for intraoperative positioning, which facilitates medical staff to accurately control the implantation of the sheath 1 in the corresponding position with the assistance of imaging equipment. The two contrast markers 102 are respectively set at both ends of the side hole area, which can more clearly identify the position of the side hole area and ensure that the blood supply area accurately corresponds to the distal ischemic vessel.

[0028] like Figure 3 As shown, a protective sleeve 5 is fitted over the sheath 1, and the protective sleeve 5 is made of hard plastic. The size of the protective sleeve 5 exactly covers the entire area of ​​the sheath 1, protecting the through hole 101 from blockage and the tip of the sheath 1 from damage before storage, transportation, and implantation. The end of the protective sleeve 5 has an annular snap-fit ​​groove, which can be snapped and fixed with the outer peripheral protrusion of the connector 2 to achieve a stable installation of the protective sleeve 5. When in use, the protective sleeve 5 can be pulled off with force to perform the corresponding operation.

[0029] The implantation method of the ECMO distal perfusion catheter is as follows: S1. The patient is placed in a supine position, and the puncture and implantation site of ECMO arterial catheter 6 is located using ultrasound equipment; routine preoperative procedures such as disinfection of the puncture area and local anesthesia are performed.

[0030] S2. Take the ECMO distal perfusion catheter from this embodiment and place it parallel to the 18F ECMO arterial catheter 6 to ensure that the implantation direction of the two catheters is consistent.

[0031] S3. Remove the protective sheath 5, adjust the distance between the puncture point of the sheath 1 and the puncture point of the ECMO arterial catheter 6 to 5cm, and puncture the two puncture points with a puncture needle (e.g., Figure 6 As shown in the figure, after successful puncture, the guidewire is inserted into the two catheters respectively, and the ECMO arterial catheter 6 and sheath 1 are simultaneously implanted to the preset depth along the guidewire; the imaging mark 102 on the sheath 1 is observed through relevant medical equipment to confirm the preset position of the side hole area, and then the guidewire is withdrawn.

[0032] S4. Connect the collateral tubing 3 to the arterial perfusion device through the three-way valve 4, turn on the perfusion device, and supply blood to the distal blood vessels through multiple through holes 101 in the side hole area; after the operation, monitor the blood flow and vital signs of the patient's distal blood vessels with ultrasound equipment. When the patient's heart rate, blood pressure and other vital signs are stable, the implantation operation is completed.

[0033] In existing technologies, distal perfusion catheters mostly use 5F or 6F arterial sheaths, which are implanted 2-5 cm distal to the ECMO arterial catheter. Figure 4 and Figure 5As shown, this technical solution has a significant drawback: competition for blood flow between the two catheters leads to slow local blood flow, which easily causes thrombosis, further aggravating distal ischemia and even causing irreversible damage such as lower limb necrosis.

[0034] The ECMO distal perfusion catheter provided by this invention achieves uniform and sufficient blood supply to distal vessels by setting a side hole area and six staggered through holes, expanding the blood supply coverage and effectively solving the problem of unstable blood supply in existing catheters. Furthermore, the distal perfusion catheter provided by this invention is implanted synchronously with the ECMO arterial catheter in the same direction and at a 5cm interval, effectively avoiding the blood flow competition and slow blood flow problems caused by two catheters being too close together or in opposite directions in existing technologies, significantly reducing the risk of thrombosis.

[0035] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An ECMO distal perfusion catheter, characterized in that, It includes a sheath (1), one end of which is provided with a connector (2), and a side branch hose (3) is provided on the connector (2). The side branch hose (3) is provided with a three-way valve (4) at the end away from the connector (2). The sheath (1) is a tubular structure, and a side hole area is provided through the side wall at the end of the sheath (1) away from the connector (2). The side hole area is used to supply blood to the patient's distal blood vessels.

2. The ECMO distal perfusion catheter according to claim 1, characterized in that, The side hole area is provided with 4-6 through holes (101), and multiple through holes (101) are located on the same side of the sheath (1), with two adjacent through holes (101) staggered.

3. The ECMO distal perfusion catheter according to claim 2, characterized in that, The spacing between two adjacent through holes (101) is the same.

4. The ECMO distal perfusion catheter according to claim 1, characterized in that, The diameter of the sheath (1) is 7F.

5. The ECMO distal perfusion catheter according to claim 1, characterized in that, The side hole area is provided with development marks (102) on both sides, and the development marks (102) are ring-shaped.

6. The ECMO distal perfusion catheter according to claim 1, characterized in that, The sheath (1) is made of stainless steel or polymer material.

7. The ECMO distal perfusion catheter according to claim 2, characterized in that, The length of the side hole region is 1.5-2.5cm.

8. The ECMO distal perfusion catheter according to claim 7, characterized in that, The diameter of the through hole (101) is 0.8-1.2 mm.

9. The ECMO distal perfusion catheter according to claim 1, characterized in that, The sheath (1) is provided with a protective sleeve (5) on the outside, and the protective sleeve (5) is snapped into the connector (2).

10. A method for implanting the distal perfusion catheter of an ECMO machine according to any one of claims 1-9, characterized in that, Includes the following steps: S1. Determine the puncture and implantation site of the ECMO arterial catheter and perform puncture pretreatment, which includes skin disinfection and local anesthesia; S2. Arrange the sheath (1) and the ECMO arterial catheter in the same direction to ensure that the implantation direction of the sheath (1) and the ECMO arterial catheter is consistent; S3. Maintain a distance of 5-6 cm between the implantation site of the sheath (1) and the implantation site of the ECMO arterial catheter, and perform puncture and implantation simultaneously; S4. Blood is supplied to the distal blood vessel through multiple through holes (101) in the side hole area. Postoperatively, the blood flow and vital signs of the patient's distal blood vessel are monitored to complete the implantation operation.

Images