Pre-filled sterile P-M pipeline auxiliary connector for ECMO

Abstract

The invention discloses a pre-charging type sterile P-M pipeline auxiliary connector for ECMO, and belongs to the field of medical instruments. Comprising an outer shell, the outer shell is formed by a first half shell and a second half shell in a separable butt joint mode, when the first half shell and the second half shell are in butt joint, a closed inner cavity is formed, and the inner cavity is used for containing fluid; wherein the first half shell and the second half shell are connected with each other through a connecting mechanism and are configured to be removed from the catheter by separating the first half shell and the second half shell after the patient end catheter and the machine end catheter are connected. By means of the arrangement, bubbles can be discharged conveniently and can be directly removed from the outside of the catheter after the catheter at the patient end is in butt joint with the catheter at the machine end, and single-person operation can be achieved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a pre-filled sterile PM tubing auxiliary connector for ECMO. Background Technology

[0002] Extracorporeal membrane oxygenation (ECMO) is a type of extracorporeal life support technology. It is used to temporarily partially or completely replace a patient's cardiopulmonary function, allowing them to rest fully and buying time for the diagnosis and treatment of the underlying disease. It is an important supportive measure for treating severe respiratory / circulatory failure. The operation of an ECMO system depends on a tight connection between the patient-side catheter (P-tube) and the machine-side catheter (M-tube). However, the connection between the P-tube and M-tube in traditional operations is complex. ECMO initiation needs to be completed within 15-20 minutes. However, when connecting the patient-side tubing and the machine-side tubing using traditional methods, at least two people are required: one person holds the P-tube and M-tube tips firmly and connects them, while the other person flushes the interface gaps with a saline syringe to remove air bubbles. This method requires a high level of hand strength, skill, and coordination, and is prone to multiple attempts due to inaccurate alignment, thus delaying treatment time.

[0003] Traditional methods rely on manual flushing, which may leave air bubbles on the tube walls. If these air bubbles enter the body through the bloodstream, they can cause air embolism and endanger life. Existing auxiliary devices, such as the air bubble removal device disclosed in Chinese patent CN217286892U, passively remove air bubbles by immersing a container in saline solution, but the container needs to be cut off with tools afterward, making it difficult to remove quickly.

[0004] Therefore, there is an urgent need for an auxiliary device that facilitates the removal of air bubbles and can be directly removed after the conduit is connected. Summary of the Invention

[0005] To overcome the problems mentioned in the background art, the present invention adopts the following technical solution: An ECMO pre-filled sterile PM tubing auxiliary connector includes: a housing, the housing being formed by a first half-shell and a second half-shell being detachably connected, wherein when the first half-shell and the second half-shell are connected, a closed inner cavity is formed, the inner cavity being used to contain fluid; The first half-shell and the second half-shell are connected to each other by a connecting mechanism. After the patient end catheter and the machine end catheter are connected, the first half-shell and the second half-shell are separated radially along the catheter and removed from the catheter.

[0006] Furthermore, the connecting mechanism includes an elastic strip surrounding the edge of the first half-shell and a snap-fit ​​groove surrounding the edge of the second half-shell, for realizing quick docking and separation between the half-shells. When the first half-shell is connected to the second half-shell, the elastic strip abuts against the inner wall of the snap-fit ​​groove to achieve a sealed connection between the first half-shell and the second half-shell, preventing fluid leakage.

[0007] Furthermore, the housing is internally connected to a guide structure, which includes a tapered tubular structure extending inward from the inner wall of the housing. The inner diameter of the tapered tubular structure gradually narrows along the insertion direction of the catheter, and is used to guide the patient-end catheter and the machine-end catheter to axially align.

[0008] Furthermore, the interior of the outer shell is provided with an elastic expansion structure, which includes a plurality of elastic sheets. When the first half-shell is connected to the second half-shell, the elastic sheets are distributed around the axis of the tapered tubular structure and configured to provide radial expansion or contraction through elastic deformation when the conduit is docked.

[0009] Furthermore, the first half-shell and the second half-shell are provided with semi-circular notches at corresponding positions on their edges. When the first half-shell and the second half-shell are joined together, the semi-circular notches combine to form a circular notch, which communicates with the inner cavity. The guide structure includes an annular base, which is configured to engage with the circular notch to detachably install the guide structure onto the outer shell.

[0010] Furthermore, the guide structure also includes a tapered section, which is fixedly connected to the annular base. The tapered section is formed by the closing of a fan-shaped plate, which has a first side edge and a second side edge. The first side edge is provided with a slot, and the second side edge is provided with a buckle. The buckle is configured to be inserted into the slot to cause the fan-shaped plate to curl into a tapered structure. When the inner diameter of the tapered section is expanded by the guide tube, the thickness of the fan-shaped plate decreases, so that the buckle is pressed into the slot to prevent it from coming out.

[0011] Furthermore, the outer wall of the tapered segment is surrounded by an annular groove, and an elastic buckle is provided in the annular groove. The elastic buckle is configured to retract radially after the buckle is inserted into the slot, so as to further enhance the structural stability of the tapered segment.

[0012] Furthermore, the inner wall of the housing is provided with an exhaust membrane, which covers the opening in the wall of the housing and is configured to allow gas to pass through while blocking liquid.

[0013] In addition, a catheter connection method based on an auxiliary device is also included, which includes the following steps: S1, passing the patient-end catheter and the machine-end catheter from the outside of the housing through the tapered section of the guide structure and into the inner cavity of the housing, and keeping the two catheters axially aligned and not in contact with each other in the inner cavity; S2. Continue to advance the patient-end catheter and the machine-end catheter, so that the inner wall of the patient-end catheter contacts the concave surface of the elastic expansion structure to expand radially along the expansion surface, while the outer wall of the machine-end catheter contacts the convex surface of the elastic expansion structure to close radially along the closing surface, until the two catheters overlap axially but do not actually contact each other. S3. Further advance the machine-end catheter so that it passes through the elastic expansion structure and is inserted into the patient-end catheter, achieving a sealed contact between the outer wall of the machine-end catheter and the inner wall of the patient-end catheter, thus completing the circuit closure.

[0014] Furthermore, in the pre-docking stage: when the patient-end catheter moves along the concave surface of the elastic expansion structure, the radius of curvature of the concave surface gradually increases, causing the patient-end catheter to expand radially; when the machine-end catheter moves along the convex surface of the elastic expansion structure, the radius of curvature of the convex surface gradually decreases, causing the machine-end catheter to contract radially; wherein, the surface parameters of the concave and convex surfaces are configured such that the axial overlap length of the patient-end catheter and the machine-end catheter accounts for 10%–30% of the total catheter length.

[0015] Furthermore, during the docking closure phase: when the machine-end catheter passes through the elastic expansion structure, multiple elastic plates of the elastic expansion structure generate an elastic restoring force. The restoring force acts on the outer wall of the machine-end catheter, causing it to accelerate its sliding into the patient-end catheter. The angle between the direction of the restoring force and the catheter advancement direction is an acute angle to provide an axial component force to assist docking.

[0016] The beneficial effects of this invention are: 1. The present invention features a detachable outer shell structure. The first half-shell and the second half-shell are connected by a connecting mechanism to form a closed inner cavity, which enables the outer shell to be quickly removed after the conduit is connected by a separation operation. This solves the problems of low operating efficiency and high safety risks caused by the inability of traditional devices to be removed from the outside of the conduit.

[0017] 2. The present invention provides a guide structure, including an annular base and a tapered section that engage with the circular notch of the outer shell. The guide structure provides a natural guiding path during catheter insertion through the tapered section's tapered design, ensuring precise alignment of the P-tube and M-tube, reducing manual offset adjustments, and thus guiding the P-tube and M-tube to automatically align axially. This solves the problems of low catheter docking accuracy and the need for repeated adjustments.

[0018] 3. This invention combines a venting membrane with an inner cavity pre-filled with physiological saline. The microporous structure of the venting membrane allows gas to be passively expelled while blocking liquid. Combined with the pre-filled physiological saline inside the outer shell, a closed fluid environment is formed when the catheter is connected, automatically driving air bubbles towards the venting membrane upon catheter insertion. This helps eliminate human error in traditional flushing or aspiration operations, requiring no manual intervention and thus solving the problems of reliance on manual, inefficient, and incomplete bubble removal.

[0019] 4. The present invention is provided with a guiding structure, an elastic expansion structure and a handle provided on the outer shell. Under the synergistic effect of the above features, the docking process of the catheter and the disassembly process of the device can be completed independently by only one operator without the assistance of an assistant. This solves the problems of high labor costs and poor operation coordination when docking the sleeve and eliminating air bubbles using traditional methods. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein: Figure 1 This is a perspective view of an assembly structure according to the present invention; Figure 2 This is a three-dimensional cross-sectional view of the present invention; Figure 3 This is a top view of a cross-sectional structure according to the present invention; Figure 4 for Figure 3 Enlarged view of the local structure at point A; Figure 5 A perspective view of an assembly structure of the present invention when the patient-end catheter and the machine-end catheter are inserted into the outer shell facing each other; Figure 6 A top view cross-sectional view of one embodiment of the present invention when the patient-end catheter and the machine-end catheter are inserted into the housing facing each other. Figure 7 Another top view cross-sectional view of the present invention when the patient-end catheter and the machine-end catheter are inserted into the housing facing each other; Figure 8 for Figure 7 Enlarged view of the local structure at point B; Figure 9 A top view cross-sectional view of one embodiment of the present invention when the patient-end catheter and the machine-end catheter are connected in the lumen; Figure 10 for Figure 9 Enlarged view of the local structure at point C; Figure 11This is a schematic diagram of the overall structure when the outer shell is separated into the first half-shell and the second half-shell. Figure 12 A schematic diagram of an overall structure when the guide structure unfolds into a fan-shaped piece; Figure 13 An exploded view of the present invention after assembling the outer shell with the separation auxiliary structure and the anti-collision pad; In the diagram, 1. Outer shell; 11. First half-shell; 111. Elastic strip; 12. Second half-shell; 121. Snap-fit ​​groove; 13. Inner cavity; 14. Guide structure; 141. Annular base; 142. Conical section; 1421. First side edge; 1422. Slot; 1423. Second side edge; 1424. Snap fastener; 1425. Annular groove; 143. Elastic buckle; 15. Elastic expansion structure; 151. Elastic sheet; 1511. Free end; 152. Semi-ring structure; 16. Circular notch; 161. Semi-circular notch; 17. Exhaust membrane; 18. Handle; 19. Anti-collision pad; 2. Patient end catheter; 21. Anti-dislodgement structure; 211. First slope; 212. Second slope; 3. Machine end catheter; 4. End marking. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention are clearly and completely described below through specific examples. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. 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] A pre-filled sterile PM tubing auxiliary connector for ECMO, such as Figure 1-13 As shown, it includes: an outer shell 1, which is formed by a first half shell 11 and a second half shell 12 that are detachably joined together. When the first half shell 11 and the second half shell 12 are joined together, a closed inner cavity 13 is formed, which is used to contain fluid. The first half-shell 11 and the second half-shell 12 are interconnected by a connecting mechanism. After the patient-end catheter 2 and the machine-end catheter 3 are connected, the first half-shell 11 and the second half-shell 12 separate radially along the catheter, thus detaching from the catheter. The detachable outer shell 1 design provides a closed saline environment during catheter docking to passively eliminate air bubbles, and allows for rapid removal after docking through partial separation, avoiding permanent integration or complex disassembly of the device, thereby improving operational efficiency and reducing hand strain. This solves the problems of laborious and high failure rates of traditional manual docking, and the inability to remove the device after catheter docking when using auxiliary devices. Handles 18 are provided on the outer walls of the first half-shell 11 and the second half-shell 12. The two handles 18 are symmetrically arranged on the outer walls away from the edges of the half-shells. After docking the P-tube and M-tube, the user can grasp the handles 18 on both sides and pull them outwards to separate the elastic strip 111 from the snap-fit ​​groove 121, thereby disassembling the two half-shells and removing the outer shell 1. It should be noted that the outer diameter of the patient end catheter 2 remains unchanged during its assembly with the machine end catheter 3. When the patient end catheter 2 moves, it pushes each elastic piece 151 inserted into the machine end catheter 3 to open outward along the radial direction of the catheter and expands the inner diameter of the machine end catheter 3, thereby assisting the two to complete the insertion by combining the opposing movements of the P tube and the M tube.

[0023] In some embodiments of this application, such as Figure 1-13 As shown, the connecting mechanism includes an elastic strip 111 surrounding the edge of the first half-shell 11 and a snap-fit ​​groove 121 surrounding the edge of the second half-shell 12. These mechanisms enable quick docking and separation between the half-shells. When the first half-shell 11 and the second half-shell 12 are connected, the elastic strip 111 abuts against the inner wall of the snap-fit ​​groove 121 to achieve a sealed connection between the two half-shells, preventing fluid leakage. This reduces operational steps, improves efficiency in emergency situations, and enables a stable connection and convenient separation of the outer shell 1, eliminating the need for tools.

[0024] In some embodiments of this application, such as Figure 1-13As shown, the housing 1 has an internal guide structure 14. The guide structure 14 includes a tapered tubular structure extending inward from the inner wall of the housing 1. The inner diameter of the tapered tubular structure tapers along the insertion direction of the catheter and maintains a closed end in its natural state, preventing fluid in the inner cavity 13 from overflowing unidirectionally through the tapered tubular structure. This guide structure is used to axially align the patient-end catheter 2 and the machine-end catheter 3, and provides a unidirectional flow guidance effect. The tapered tubular structure's tapering design automatically corrects the position during catheter insertion, achieving automatic alignment and reducing the risk of misalignment during catheter docking, thus reducing the burden of manual adjustment. At least one thin film is laid on the outer surface of the housing 1 corresponding to the guide structure 14. This film maintains a sterile environment between the guide structure 14 and the film when not in use, and provides an additional barrier to prevent liquid leakage from the housing 1, improving safety during storage and transfer. Alternatively, the film completely covers the outside of this assistive device. The film is made of polyethylene, polypropylene, or polyvinyl chloride, and its thickness does not exceed 1 mm. The film is connected to the outer casing 1 by heat sealing or adhesive bonding, and is removed before the P tube and M tube are inserted into the outer casing 1.

[0025] In some embodiments of this application, such as Figure 1-13 As shown, the interior of the outer shell 1 is provided with an elastic expansion structure 15. The elastic expansion structure 15 includes multiple elastic sheets 151 and semi-ring structures 152 respectively connected to the inner walls of the first half-shell 11 and the second half-shell 12. Each semi-ring structure 152 is fixedly connected with at least two petal-shaped elastic sheets 151. When the first half-shell 11 and the second half-shell 12 are connected, the elastic sheets 151 are distributed around the axis of the conical tubular structure and configured to provide radial expansion or contraction through elastic deformation when the conduit is docked. The elastic sheet 151 includes a free end 1511 pointing into the M tube and a fixed end fixedly connected to the semi-ring structure 152. From the fixed end to the free end 1511, the thickness of the elastic sheet 151 gradually decreases, and the thickness of the free end 1511 is no more than 1 mm, so as to reduce the degree of expansion of the elastic sheet 151 on the inner diameter of the M tube during the process of guiding the P tube into the M tube, and avoid the plastic deformation of the M tube during the process. It should be noted that the elastic piece 151 is made of stainless steel, cobalt-based alloy, or titanium-based alloy to ensure that the end of the elastic piece 151 can slightly deform during the insertion of the P tube and open the inner wall of the M tube outward. The elastic piece 151 is designed in a petal shape to evenly transfer the pressure from the outer wall of the P tube to the inner wall of the M tube during the insertion of the two conduits. After the end of the P tube passes the free end 1511 of the elastic piece 151 and is inserted into the M tube more than 1.5 cm, the outer shell 1 is pushed away from the M tube to remove the elastic piece 151 from the inside of the M tube. At this point, the two half-shells are separated, completing the initial disassembly of the connector.

[0026] The elastic plate 151 undergoes elastic deformation upon contact with the conduit, dispersing axial force, reducing resistance, and minimizing the hand strength required for insertion, thus preventing hand injury. Specifically, the outer diameter of tube M is larger than that of tube P, and the insertion end of tube M is the end with elastic plate 151 facing upwards. Figure 11 As shown, the outer wall of the corresponding end of the outer shell 1 is provided with an end mark 4 for the insertion end of the P-tube and the insertion end of the M-tube. With this arrangement, when the M-tube enters the inner cavity 13 through the guide structure 14 and continues to move, it can fit around the elastic expansion structure 15 and expand to guide the insertion of the P-tube. Furthermore, the outer surfaces of the first half-shell 11 and the second half-shell 12 are respectively composed of multiple curved surfaces or planes, and the end mark 4 can be provided on one or more of these outer surfaces. The specific structure of the end mark 4 is a P-shaped boss or groove, and an M-shaped boss or groove. The end mark 4 may also include an arrow-shaped boss pointing to the corresponding insertion end.

[0027] In addition, several anti-detachment structures 21 are arranged around the outer wall of the P-tube. The anti-detachment structure 21 is an annular protrusion with a triangular cross-section. The annular protrusions are evenly distributed along the axial direction of the P-tube, and the distance between adjacent annular protrusions is not less than 5mm. The annular protrusion includes a first slope 211 and a second slope 212 with an included angle. Specifically, the first slope 211 faces the M-tube when connected, and the second slope 212 faces away from the M-tube. The slope of the first slope 211 is not greater than 15°, so as to reduce the resistance when the P-tube is inserted into the M-tube; the slope of the second slope 212 is not less than 30°. A side ridge is formed at the junction of the first slope 211 and the second slope 212. After the P-tube enters the M-tube, the side ridge increases the contact friction between the P-tube and the M-tube, thereby preventing the P-tube from detaching from the M-tube after insertion. When the annular protrusion passes over the free end 1511 as it passes through the elastic expansion structure 15 at the end of the P tube, the second slope 212 will abut against the free end 1511 as the P tube comes out of the elastic expansion structure 15 in the opposite direction, thereby preventing the P tube from detaching from the housing 1 along the insertion direction.

[0028] In some embodiments of this application, such as Figure 1-13As shown, the first half-shell 11 and the second half-shell 12 have semi-circular notches 161 at corresponding positions on their edges. When the first half-shell 11 and the second half-shell 12 are joined together, the semi-circular notches 161 combine to form a circular notch 16, which communicates with the inner cavity 13. The guide structure 14 includes an annular base 141, which is configured to engage with the circular notch 16 to detachably mount the guide structure 14 onto the outer shell 1. The engagement design of the circular notch 16 and the annular base 141 allows the guide structure 14 to be installed and removed independently of the outer shell 1, improving operational flexibility and avoiding a bulky overall device. This enables rapid separation of the guide structure 14 from the outer shell 1, facilitating the sequential removal of the outer shell 1 and the guide structure 14 after the conduit connection. In some embodiments, the outer wall of the housing 1 is provided with anti-collision pads 19. The anti-collision pads 19 are semi-annular or arc-shaped structures made of foam or silicone material. The anti-collision pads 19 are respectively arranged around the semi-circular notches 161 on the outer walls of the first half-shell 11 and the second half-shell 12, and form an anti-collision area around the circular notches 161 after the two half-shells are combined to form the housing 1. When the user inserts the patient end catheter 2 and the machine end catheter 3 into the housing 1 from both sides, a large pushing force needs to be applied in the direction of the housing 1. Therefore, there is a risk that the operator's hand will slip off the outer wall of the catheter and collide with the housing 1. By providing anti-collision pads 19, the injury to the patient's hand caused by slipping and impacting the housing 1 due to force can be effectively reduced.

[0029] In some embodiments of this application, such as Figure 1-13 As shown, the guide structure 14 also includes a resilient tapered segment 142, which is fixedly connected to the annular base 141. The tapered segment 142 is formed by the closing of a fan-shaped plate, which has a first side edge 1421 and a second side edge 1423. The first side edge 1421 is provided with a slot 1422, and the second side edge 1423 is provided with a snap fastener 1424. The snap fastener 1424 is configured to be inserted into the slot 1422 to cause the fan-shaped plate to curl into a tapered structure. When the inner diameter of the tapered segment 142 is expanded by the conduit, the thickness of the fan-shaped plate decreases, causing the snap fastener 1424 to be pressed tightly into the slot 1422 to prevent it from coming out. Through the mechanical interlocking design of the slot 1422 and the snap fastener 1424, the connection stability is automatically enhanced under the action of the conduit expansion force, achieving self-tightening fixation. At the same time, it ensures that the guide structure 14 remains stable during conduit insertion, preventing the tapered segment 142 from accidentally unfolding. When the fan-shaped pieces close into the conical section 142, under the constraint of the elastic buckle 143, they can deform and expand according to the outer diameter of the inserted tube end, and always fit the outer wall of the tube to prevent liquid from overflowing during the insertion process.

[0030] In some embodiments of this application, such as Figure 1-13As shown, the outer wall of the tapered segment 142 is surrounded by an annular groove 1425, within which an elastic buckle 143 is disposed. The elastic buckle 143 is configured to radially retract after the snap fastener 1424 is inserted into the slot 1422, thereby further enhancing the structural stability of the tapered segment 142. Through the synergistic effect of the annular groove 1425 and the elastic buckle 143, a radial constraint force is provided to compensate for the axial locking of the snap fastener 1424 in the slot 1422. This further enhances the deformation resistance of the guide structure 14 based on the snap fastener 1424 in the slot 1422, preventing structural failure during the conduit docking process.

[0031] In some embodiments of this application, such as Figure 1-13 As shown, the inner wall of the outer casing 1 is provided with an venting membrane 17, which covers the opening on the wall of the outer casing 1. The venting membrane 17 allows gas to pass through while blocking liquid, ensuring that air bubbles in the inner cavity 13 can be discharged through the venting membrane 17. Utilizing the microporous characteristics of the venting membrane 17, air is automatically vented through pressure difference when the catheter is connected, while preventing leakage of saline solution and achieving passive removal of air bubbles, avoiding manual intervention.

[0032] In some embodiments of this application, such as Figure 1-13 As shown, the outer shell 1 is made of medical plastic or other transparent materials to facilitate observation of the internal condition, and the sealing ring enhances the sealing performance to prevent liquid leakage.

[0033] In some embodiments of this application, the inner cavity 13 is pre-filled with physiological saline when the outer shell 1 is docked, and the top of the outer shell 1 is provided with an injection port (not shown in the figure) for injecting or replenishing fluid before docking. The pre-filled design can eliminate the need for on-site injection, and the injection port facilitates adjustment of the fluid volume, improving operational flexibility, thereby simplifying fluid management and reducing preparation time.

[0034] In addition, a catheter connection method based on an auxiliary device is also included, which includes the following steps: S1, passing the patient end catheter 2 and the machine end catheter 3 from the outside of the housing 1 through the tapered section 142 of the guide structure 14 and into the inner cavity 13 of the housing 1, and keeping the two catheters axially aligned and not in contact with each other in the inner cavity 13. S2. Continue to advance the patient end catheter 2 and the machine end catheter 3, so that the inner wall of the patient end catheter 2 contacts the concave surface of the elastic expansion structure 15 to expand radially along the expansion surface, while the outer wall of the machine end catheter 3 contacts the convex surface of the elastic expansion structure 15 to close radially along the closing surface, until the two catheters overlap axially but do not actually contact each other. S3. Further advance the machine-end catheter 3, allowing it to pass through the elastic expansion structure 15 and insert into the patient-end catheter 2, achieving a sealed contact between the outer wall of the machine-end catheter 3 and the inner wall of the patient-end catheter 2, thus completing the circuit closure. Through phased operation, the three stages are catheter introduction, pre-connection, and connection closure. Utilizing the synergistic effect of the guide structure 14 and the elastic expansion structure 15, the catheter is gradually guided to achieve precise and labor-saving connection, avoiding repeated adjustments. This effectively solves the problems of high failure rate and laborious operation caused by catheter misalignment and high resistance in traditional manual connection processes.

[0035] In some embodiments of this application, such as Figure 1-13 As shown, during the pre-docking stage: when the patient-end catheter 2 moves along the concave surface of the elastic expansion structure 15, the radius of curvature of the concave surface gradually increases, causing the patient-end catheter 2 to expand radially; when the machine-end catheter 3 moves along the convex surface of the elastic expansion structure 15, the radius of curvature of the convex surface gradually decreases, causing the machine-end catheter 3 to contract radially. The surface parameters of the concave and convex surfaces are configured such that the axial overlap length of the patient-end catheter 2 and the machine-end catheter 3 is not less than 1.5 cm. By increasing the curvature of the concave surface and decreasing the curvature of the convex surface, the radial deformation of the catheter is controlled, ensuring that the overlap length is within a reasonable range and reducing propulsion resistance. This optimizes the catheter's movement trajectory during the pre-docking stage, reduces axial resistance, and avoids jamming.

[0036] In some embodiments of this application, such as Figure 1-13 As shown, during the docking closure phase: when the machine-end catheter 3 passes through the elastic expansion structure 15, multiple elastic plates 151 of the elastic expansion structure 15 generate an elastic restoring force. This restoring force acts on the outer wall of the machine-end catheter 3, accelerating its sliding into the patient-end catheter 2. The angle between the direction of the restoring force and the catheter advancement direction is acute, providing an axial component force to assist docking. Through the elastic restoring characteristics of the elastic plates 151, the radial constraint force is converted into an axial propulsion force, achieving the assisted insertion of the P-tube and M-tube. Utilizing the structural elastic force to assist catheter insertion further reduces the burden on manual advancement.

[0037] After assisting in fitting the P-tube and M-tube together, the operator needs to disassemble the outer shell 1 and the guide structure 14 in sequence. Grasp the handles 18 symmetrically arranged on the outer walls of the first half-shell 11 and the second half-shell 12, and pull them outwards to disengage the elastic strip 111 of the connecting mechanism from the snap-fit ​​groove 121, thereby separating the first half-shell 11 and the second half-shell 12 and removing the outer shell 1. After removing the outer shell 1, first remove the elastic buckle 143 on the guide structure 14. The elastic buckle 143 is specifically an elastic rope connected at both ends by bolts or hooks, so that the elastic buckle 143 can be removed only by unfastening or unhooking, without unraveling and returning to its original rope state as the outer diameter of the tapered section 142 expands. Then, pry open the slot 1422 radially to both sides of the guide structure 14, opening the slot 1422, and remove the buckle 1424, thereby allowing the guide structure 14 to unfold into a fan-shaped piece and be removed from the guide tube. The thickness of the slot 1422 can only decrease as the conduit expands during insertion. Therefore, this process does not satisfy the condition that the slot 1422 opens radially to both sides of the guide structure 14 to release the latch 1424. This ensures the structural stability of the guide structure 14 during conduit insertion and prevents it from disintegrating during conduit docking. By setting up segmented removal of the outer shell 1 first and then the guide structure 14, using the handle 18 to provide a force application point, combined with the mechanical release mechanism of the elastic strip 111 and the snap-fit ​​groove 121, and the unfoldable design of the guide structure 14, gradual removal is achieved, ensuring simple operation and no damage to the conduit, thereby preventing the device from remaining on the conduit wall.

Claims

1. A pre-filled sterile PM tubing auxiliary connector for ECMO, characterized in that, include: The outer shell is composed of a first half-shell and a second half-shell that are detachably joined together. When the first half-shell and the second half-shell are joined together, a closed inner cavity is formed, which is used to contain fluid. The first half-shell and the second half-shell are connected to each other by a connecting mechanism. After the patient end catheter and the machine end catheter are connected, the first half-shell and the second half-shell are separated radially along the catheter and removed from the catheter.

2. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 1, characterized in that, The connecting mechanism includes an elastic strip surrounding the edge of the first half-shell and a snap-fit ​​groove surrounding the edge of the second half-shell, for realizing quick docking and separation between the half-shells. When the first half-shell is connected to the second half-shell, the elastic strip abuts against the inner wall of the snap-fit ​​groove to achieve a sealed connection between the first half-shell and the second half-shell.

3. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 1 or 2, characterized in that, The housing has an internal guide structure, which includes a tapered tubular structure extending inward from the inner wall of the housing. The inner diameter of the tapered tubular structure gradually decreases along the insertion direction of the catheter, and is used to guide the patient-end catheter and the machine-end catheter to axially align.

4. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 3, characterized in that, The shell has an internal elastic expansion structure, which includes multiple elastic sheets. When the first half-shell is connected to the second half-shell, the elastic sheets are distributed around the axis of the conical tubular structure and provide radial expansion or contraction of the conduit through elastic deformation during the conduit docking process.

5. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 3, characterized in that, The first half-shell and the second half-shell have semi-circular notches at corresponding positions on their edges. When the first half-shell and the second half-shell are joined together, the semi-circular notches combine to form a circular notch, which communicates with the inner cavity. The guide structure includes an annular base, which engages with the circular notch to detachably mount the guide structure onto the outer shell.

6. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 5, characterized in that, The guide structure further includes a tapered section, which is fixedly connected to the annular base. The tapered section is formed by the closing of a fan-shaped plate, which has a first side edge and a second side edge. The first side edge is provided with a slot, and the second side edge is provided with a buckle. The buckle is configured to be inserted into the slot to cause the fan-shaped plate to curl into a tapered structure. When the inner diameter of the tapered section is expanded by the guide tube, the thickness of the fan-shaped plate decreases, so that the buckle is pressed into the slot to prevent it from coming out.

7. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 1, characterized in that, The outer wall of the tapered section is surrounded by an annular groove, and an elastic buckle is provided in the annular groove. The elastic buckle has a tendency to contract radially within the annular groove.

8. The pre-filled sterile PM tubing auxiliary connector for ECMO according to claim 1, characterized in that, The inner wall of the housing is provided with an exhaust membrane, which allows gas to pass through while blocking liquid from passing through.

9. A catheter connection method using a pre-filled sterile PM tubing auxiliary connector for ECMO, characterized in that, Includes the following steps: S1. Pass the patient-end catheter and the machine-end catheter from the outside of the housing through the tapered section of the guide structure and into the inner cavity of the housing, keeping the two catheters axially aligned and not in contact with each other within the inner cavity; S2. Continue to advance the patient-end catheter and the machine-end catheter, so that the inner wall of the patient-end catheter contacts the concave surface of the elastic expansion structure to expand radially along the expansion surface, while the outer wall of the machine-end catheter contacts the convex surface of the elastic expansion structure to close radially along the closing surface, until the two catheters overlap axially but do not actually contact each other. S3. Further advance the machine-end catheter so that it passes through the elastic expansion structure and is inserted into the patient-end catheter, achieving a sealed contact between the outer wall of the machine-end catheter and the inner wall of the patient-end catheter, thus completing the circuit closure.

10. The method according to claim 9, characterized in that, In the pre-docking phase: As the patient-end catheter moves along the concave surface of the elastic expansion structure, the radius of curvature of the concave surface gradually increases, causing the patient-end catheter to expand radially. As the machine-end conduit moves along the convex surface of the elastic expansion structure, the radius of curvature of the convex surface gradually decreases, causing the machine-end conduit to radially converge.

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