WO2025043883A1 - Dual lumen cannula - Google Patents
Dual lumen cannula Download PDFInfo
- Publication number
- WO2025043883A1 WO2025043883A1 PCT/CN2023/130432 CN2023130432W WO2025043883A1 WO 2025043883 A1 WO2025043883 A1 WO 2025043883A1 CN 2023130432 W CN2023130432 W CN 2023130432W WO 2025043883 A1 WO2025043883 A1 WO 2025043883A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- drainage
- pipe section
- tube
- reflux
- return pipe
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Definitions
- the present invention relates to the field of medical devices, and in particular to a double-lumen cannula.
- the cannula is a key component in the extracorporeal membrane oxygenation (ECMO) system that is directly connected to the human blood vessels. It is a bridge connecting the ECMO extracorporeal circulation pipeline and the human blood vessels, and plays a vital role in the normal function of the ECMO system.
- An ECMO system contains two cannulas, one for drawing out human venous blood, and one for returning arterial blood after oxygenation by the ECMO system to the human blood vessels.
- the venous-to-venous cannula VV-ECMO is a cannula treatment method commonly used by the ECMO system for patients with pulmonary failure. Usually, a single-lumen cannula is used as a drainage tube.
- a femoral vein puncture operation After a femoral vein puncture operation, it is inserted into the inferior vena cava near the right atrium, and venous blood is drawn from the inferior vena cava. After oxygenation by the ECMO system, another single-lumen cannula is inserted into the superior vena cava through the internal jugular vein to return the oxygenated arterial blood to the human body.
- the existing VV-ECMO requires two cannulas, and two different blood vessels are cannulated through two surface puncture holes. The operation is complicated and will also increase the risk of infection for patients.
- the object of the present invention is to provide a double-lumen cannula so that both the drainage pipeline and the return pipeline have sufficient flow cross-sectional area to ensure the drainage and return effect.
- the present disclosure provides a double-lumen cannula, comprising:
- a drainage tube having a drainage lumen
- a return tube passes through the drainage tube, comprising a first return tube section exposed at the distal end of the drainage tube, a second return tube section built into the drainage cavity, and a third return tube section exposed at the proximal end of the drainage tube,
- the first reflux pipe segment is sealed and connected to the drainage pipe
- the proximal end of the second reflux pipe segment is sealed and connected to the third reflux pipe segment
- the distal end of the second reflux pipe segment has a fixed portion and a free portion in the circumferential direction
- the fixed portion is connected to the first reflux pipe segment
- the free portion has a first state of being in contact with the inner wall of the second reflux pipe segment and a second state of being spaced apart from the inner wall of the second reflux pipe segment.
- the fixing portion occupies less than 1/2 of the circumference of the distal end of the second return pipe segment
- the free portion accounts for more than 1/2 of the circumference of the distal end of the second return pipe segment.
- a drainage joint is provided at the proximal end of the drainage tube, and a reflux joint is provided on the third reflux tube section.
- the second return pipe section is a thin-walled deformable flexible tube; the wall thickness of the second return pipe section is smaller than the wall thickness of the first return pipe section; the wall thickness of the second return pipe section is smaller than the wall thickness of the drainage pipe.
- a drainage hole is provided on the side wall at the distal end of the drainage tube, and a reflux hole is provided on the side wall at the distal end of the first reflux tube section; after the intubation is completed, the drainage hole is located in the inferior vena cava, the superior vena cava or the right atrium.
- a first through hole is provided at the distal end of the drainage tube, and the first reflux pipe section passes through the first through hole and is sealed and connected to the hole wall of the first through hole.
- the outer diameter of the first return pipe section is smaller than the outer diameter of the drainage pipe
- the outer wall of the first reflux pipe section transitions smoothly with the outer wall of the drainage pipe.
- the first reflux pipe section and the drainage pipe are integrally formed.
- a second through hole is provided on the side wall of the proximal end of the drainage tube, the reflux tube passes through the second through hole and extends toward the distal end of the drainage tube, and the drainage tube is sealedly connected to the hole wall of the second through hole.
- the angle between the second return pipe section and the third return pipe section is greater than 90°.
- the second return pipe section and the third return pipe section are integrally formed.
- a first support body is provided in the tube wall of the first reflux pipe section; the first support body is used to prop open the tube wall of the first reflux pipe section and make the first reflux pipe section bendable;
- the density of the first support body on the first reflux pipe section away from the drainage pipe is lower than that on the side close to the drainage pipe, and the flexibility of the first reflux pipe section away from the drainage pipe is higher than that on the side close to the drainage pipe.
- the length of the reflux tube is greater than that of the drainage tube.
- the double-lumen cannula provided by the present invention has both a drainage tube and a reflux tube, which are integrated into a single tube. When used, only one puncture hole needs to be formed on the body surface, and the risk of bleeding and infection is significantly reduced compared with the conventional method of forming two puncture holes on the body surface.
- the second reflux tube section is partially connected to the first reflux tube section.
- the guide core is inserted into the drainage tube and the first reflux tube section, and the second reflux tube section is squeezed to one side. Since the guide core does not need to pass through the second reflux tube section, the second reflux tube section does not need to adapt to the size of the guide core. Its diameter and wall thickness can be made smaller, reducing the occupation of the drainage cavity cross-sectional area, making the flow cross-sectional area between the inner wall of the drainage tube and the outer wall of the second reflux tube section larger.
- the present invention expands the flow area of venous blood drainage by reducing the cross-sectional proportion of the reflux tube in the drainage cavity, so that both the drainage tube and the reflux tube have sufficient flow cross-sectional area to ensure the drainage reflux effect.
- FIG1 is a front view of a double-lumen cannula provided in an embodiment of the present application.
- FIG2 is a right side view of a double lumen cannula provided in an embodiment of the present application.
- FIG3 is a cross-sectional view of a double-lumen cannula provided in an embodiment of the present application.
- FIG4 is a schematic diagram of a partial structure of the structure shown in FIG3 ;
- FIG5 is a schematic diagram of a partial structure of the structure shown in FIG3 ;
- FIG6 is an enlarged view of portion A in FIG5 ;
- FIG. 7 is a cross-sectional view of a guide core provided in an embodiment of the present application when placed into a double-lumen cannula;
- FIG8 is a cross-sectional view of a core guide provided in an embodiment of the present application after being withdrawn from a double-lumen cannula;
- FIG. 9 is a schematic diagram of the structure of the guide core provided in an embodiment of the present application.
- the terms “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inside”, “outside”, etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or are the positions or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.
- the terms “first”, “second”, “third”, etc. are only used to distinguish descriptions, and cannot be understood as indicating or implying relative importance.
- “multiple" means two or more.
- a first feature being “above” or “below” a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them.
- a first feature being “above”, “above” and “above” a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature.
- a first feature being “below”, “below” and “below” a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.
- the present embodiment provides a double-lumen cannula, as shown in Figures 1 to 8, the double-lumen cannula includes a drainage tube 100 and a return tube 200, the drainage tube 100 has a drainage cavity 101 inside, the return tube 200 passes through the drainage tube 100, the return tube 200 includes a first return tube segment 201, a second return tube segment 202 and a third return tube segment 203, the first return tube segment 201 is exposed at the distal end of the drainage tube 100, the third return tube segment 203 is exposed at the proximal end of the drainage tube 100, the second return tube segment 202 is built in the drainage cavity 101, and the two ends of the second return tube segment 202 are respectively connected to the third return tube segment 203 and the first return tube segment 201.
- the length of the return tube 200 is greater than the length of the drainage tube 100.
- the proximal end of the drainage tube 100 is provided with a drainage joint 102, and the third return tube segment 203 is provided with a return joint 206. 4 and 5 , a drainage hole 104 is provided on the side wall at the distal end of the drainage tube 100, and a reflux hole 207 is provided on the side wall at the distal end of the first reflux tube section 201.
- a gap 103 is left between the outer wall of the second reflux tube section 202 and the inner wall of the drainage tube 100, allowing venous blood entering from the drainage hole 104 to flow to the drainage connector 102 through the gap 103.
- the drainage hole 104 on the double-lumen cannula is used to drain venous blood from the body
- the reflux hole 207 is used to return oxygen-rich arterial blood to the body.
- the positions of the drainage hole 104 and the reflux hole 207 can be designed according to the specific use site and body size. For example, according to the distance between the predetermined position of venous blood and the predetermined position of the returned arterial blood, the distance between the drainage hole 104 and the reflux hole 207 can be changed to ensure that the drainage hole 104 and the reflux hole 207 can be accurately delivered to the designated position.
- the first reflux pipe section 201 is sealed and connected to the drainage pipe 100, and the proximal end of the second reflux pipe section 202 is sealed and connected to the third reflux pipe section 203.
- the distal end of the second reflux pipe section 202 has a fixed portion 204 and a free portion 205 in the circumferential direction.
- the fixed portion 204 is connected to the first reflux pipe section 201, and the free portion 205 has a second reflux pipe section 203.
- the first return pipe segment 201, the second return pipe segment 202 and the third return pipe segment 203 are connected in sequence to form a flow channel 211 for draining arterial blood, as shown in Figure 8.
- an avoidance channel 210 is formed between the outer wall of the second return pipe segment 202 and the inner wall of the first return pipe segment 201, allowing the guide core 300 used for the double-lumen cannula to pass through, as shown in Figure 7.
- the fixed portion 204 accounts for less than 1/2 of the circumference of the distal end of the second return pipe segment 202
- the free portion 205 accounts for more than 1/2 of the circumference of the distal end of the second return pipe segment 202, so as to ensure that after the deformation of the free portion 205, there is a large enough channel between the outer wall of the second return pipe segment 202 and the inner wall of the first return pipe segment 201 for the guide core 300 to pass through.
- the fixed portion 204 accounts for 1/3 of the circumference of the distal end of the second return pipe segment 202
- the free portion 205 accounts for 2/3 of the circumference of the distal end of the second return pipe segment 202
- the fixed portion 204 is bonded to the inner wall of the second return pipe segment 202.
- the second return pipe section 202 is a thin-walled deformable flexible tube, and the free portion 205 of the second return pipe section 202 can approach the fixed portion 204 after being squeezed by the guide core 300.
- the wall thickness of the second return pipe section 202 is less than that of the first return pipe section 201; the wall thickness of the second return pipe section 202 is less than that of the drainage tube 100.
- a first support body 208 is provided in the tube wall of the first return pipe section 201, and the first support body 208 is used to prop open the tube wall of the first return pipe section 201 and make the first return pipe section 201 bendable.
- a second support body 107 is provided in the tube wall of the drainage tube 100, and the second support body 107 is used to prop open the tube wall of the drainage tube 100 and make the drainage tube 100 bendable.
- the first support body 208 and the second support body 107 can be support bodies with a spiral structure or a mesh structure, such as a support spring.
- the first return pipe section 201 and the drainage tube 100 are to be placed in the body.
- the first return pipe section 201 and the drainage tube 100 have certain support strength and flexibility, and can reach the predetermined position along the complete blood vessel pipeline.
- the second return pipe section 202 is built into the drainage cavity 101 and does not need to directly contact the blood vessel wall. In this embodiment, no support body is set in the second return pipe section 202. Under the condition of the same flow cross-sectional area, the wall of the second return pipe section 202 can be made thinner, reducing the cross-sectional area of the return pipe 200 in the drainage cavity 101, and expanding the flow area of venous blood drainage.
- the density of the first support 208 on the side of the first return pipe section 201 away from the drainage pipe 100 is less than the density of the first support 208 on the side close to the drainage pipe 100, and the flexibility of the side of the first return pipe section 201 away from the drainage pipe 100 is greater than the flexibility of the side close to the drainage pipe 100.
- the density of the second support 107 at different positions on the second return pipe section 202 is adjusted so that different positions of the second return pipe section 202 correspond to different bending strengths, and the denser the second support 107, the greater the bending strength.
- relatively sparse springs are set on the second return pipe segment 202 away from the drainage tube 100, and relatively dense springs are set on the second return pipe segment 202 close to the drainage tube 100. Then, the bending strength of the second return pipe segment 202 close to the drainage tube 100 is greater than the bending strength of the second return pipe segment 202 away from the drainage tube 100. In this way, the distal end of the second return pipe segment 202 can be made more flexible, reducing the difficulty of placing the distal end of the second return pipe segment 202 through the tricuspid valve and the pulmonary valve.
- the outer diameter of the first return tube segment 201 is smaller than the outer diameter of the drainage tube 100.
- the first return tube segment 201 serves as the head end of the entire double-lumen cannula. Reducing the outer diameter of the first return tube segment 201 is beneficial to its smooth passage in the blood vessel.
- the first return tube segment 201 is used to transport arterial blood, the pressure of arterial blood is relatively high during transportation. Even if its outer diameter and inner diameter are reduced, the arterial blood can still flow smoothly in the first return tube segment 201.
- reducing the outer diameter of the first return tube segment 201 can also reduce the trauma to the blood vessel wall, heart valve and other tissues during the insertion process.
- the outer wall of the first reflux tube section 201 transitions smoothly with the outer wall of the drainage tube 100 , and there is no step surface at the distal joint of the reflux tube 200 and the drainage tube 100 , so that the blood vessel wall will not be damaged when the cannula is inserted into the blood vessel.
- a second through hole 106 is further provided on the side wall of the proximal end of the drainage tube 100, and the return pipe 200 extends through the second through hole 106 to the distal end of the drainage tube 100, and the drainage tube 100 is sealed and connected to the hole wall of the second through hole 106.
- the angle between the second return pipe section 202 and the third return pipe section 203 is greater than 90°.
- the reflux pipe 200 is tilted at a certain angle to penetrate the drainage cavity 101 to prevent the blood from turning rapidly in the reflux pipe 200 and causing damage to blood cells.
- the second reflux pipe section 202 and the third reflux pipe section 203 are integrally formed.
- the second reflux pipe section 202 and the third reflux pipe section 203 can also be separately formed and then sealed and connected.
- the double-lumen cannula provided by the present invention has both a drainage tube 100 and a return tube 200.
- the drainage tube 100 and the return tube 200 are integrated into a single tube. When used, only one puncture hole needs to be formed on the body surface. The risk of bleeding infection is significantly reduced compared with the conventional method of forming two puncture holes on the body surface.
- the second reflux pipe section 202 is partially connected to the first reflux pipe section 201.
- the guide core 300 passes through the drainage tube 100 and the first reflux pipe section 201, and the second reflux pipe section 202 is squeezed to one side. Since the guide core 300 does not need to pass through the second reflux pipe section 202, the second reflux pipe section 202 does not need to adapt to the size of the guide core 300. Its tube diameter and wall thickness can be made smaller, reducing the cross-sectional area occupied by the drainage cavity 101, so that the flow cross-sectional area between the inner wall of the drainage tube 100 and the outer wall of the second reflux pipe section 202 is larger.
- the blood pressure of the arterial blood returned through the reflux tube 200 is greater than the blood pressure of the venous fluid drained through the drainage tube 100, even if the diameter of the second reflux tube section 202 is reduced, it will not hinder the return of arterial blood.
- the cross-sectional area of the drainage cavity 101 is constant, the cross-sectional proportion of the reflux tube 200 in the drainage cavity 101 is reduced, thereby expanding the flow area of venous blood drainage, so that both the drainage tube 100 and the reflux tube 200 have sufficient flow cross-sectional area to ensure the drainage reflux effect.
- the double-lumen catheter provided in this embodiment is inserted into the body by using a guide core.
- the guide core 300 has a guide core through hole 301 that runs through both ends of the guide core 300.
- the guide core through hole 301 is used to pass the guide wire 400.
- the guide core through hole 301 includes a docking channel 308, and the diameter of the docking channel 308 matches the diameter of the guide wire 400.
- the diameter of the docking channel 308 is slightly larger than the diameter of the guide wire 400, or the diameter of the docking channel 308 is equal to the diameter of the guide wire 400.
- the outer wall of the guide core 300 has a clamping portion. When the guide core 300 is inserted into the double-lumen cannula, the clamping portion fits with the inner wall of the drainage cavity 101 and/or the inner wall of the first reflux pipe section 201.
- the guide core 300 includes a first guide core segment 302, a second guide core segment 303, a third guide core segment 304 and a fourth guide core segment 305 connected in sequence, and the guide core through hole 301 passes through the first guide core segment 302, the second guide core segment 303, the third guide core segment 304 and the fourth guide core segment 305.
- the first core guide segment 302, the second core guide segment 303, the third core guide segment 304 and the fourth core guide segment 305 is a possible implementation, the guide core 300 includes a first guide core segment 302, a second guide core segment 303, a third guide core segment 304 and a fourth guide core segment 305 connected in sequence, and the guide core through hole 301 passes through the first guide core segment 302, the second guide core segment 303, the third guide core segment 304 and the fourth guide core segment 305.
- the outer diameter of the fourth core guide segment 305 is greater than the outer diameter of the second core guide segment 303, the outer diameter of the third core guide segment 304 gradually decreases from the side close to the fourth core guide segment 305 to the side close to the second core guide segment 303, and the outer diameter of the first core guide segment 302 gradually decreases from the side close to the second core guide segment 303 to the side away from the second core guide segment 303.
- the docking channel 308 is provided in the first core guide segment.
- the clamping portion includes a first clamping portion 306 and a second clamping portion 307, the first clamping portion 306 is provided on the first core guide segment 302, and the second clamping portion 307 is provided on the third core guide segment 304.
- the first clamping portion 306 may be located on the first core segment 302 at a position connected to the second core segment 303
- the second clamping portion 307 may be located on the third core segment 304 at a position connected to the fourth core segment 305 .
- the drainage pipe includes a drainage pipe transition section 108, the drainage pipe transition section 108 is connected to the first return pipe section 201, and the outer diameter and the inner diameter of the drainage pipe transition section 108 are gradually reduced from the side away from the first return pipe section 201 to the side close to the first return pipe section 201.
- the first return pipe section 201 has a return pipe head end 209 on the side away from the second return pipe section 202, and the inner diameter of the return pipe head end 209 is gradually reduced from the side close to the second return pipe section 202 to the side away from the second return pipe section 202.
- the first core guide segment 302 When the core guide 300 is inserted into the double-lumen cannula, the first core guide segment 302 partially extends out of the first return tube segment 201, the first clamping portion 306 fits against the inner wall of the return tube head end, and the second clamping portion 307 fits against the inner wall of the drainage tube transition section, so as to position the core guide 300 in the double-lumen cannula.
- the fitting surface between the core guide 300 and the double-lumen cannula should not be too large. If the fitting surface is too large, the friction between the double-lumen cannula and the core guide 300 will increase, which is not conducive to the withdrawal of the core guide 300.
- the guide core 300 is passed through the drainage joint 102, the drainage cavity 101 and the first return pipe section 201 in sequence. At this time, the guide core 300 squeezes the second return pipe section 303 to one side, and the front end of the first guide core section 302 of the guide core 300 passes through the first return pipe section 201.
- the first clamping portion 306 at the rear end of the first guide core section 302 is connected to the first return pipe section 201.
- the inner wall of the return tube head end 209 on the guide core 300 is in contact with the inner wall of the drainage tube transition section 108, and the second clamping portion 307 on the third guide core segment 304 is in contact with the inner wall of the drainage tube transition section 108.
- the first guide core segment 302 is at the head end of the guide core 300
- the fourth guide core segment 305 is at the tail end of the guide core 300.
- the head end of the guide wire 400 is sent into a designated position (such as the left atrium) along the blood vessel through the puncture hole on the body surface, and the tail end of the guide wire 400 is exposed outside the body surface.
- the second reflux tube section 303 can expand under the impact of the arterial blood, so that the outer wall of the second reflux tube 303 is close to the inner wall of the first reflux tube section 201, forming an arterial blood flow channel 211, ensuring that the arterial blood flows smoothly from the reflux hole 207.
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Abstract
Description
本发明涉及医疗器械领域,特别是涉及一种双腔插管。The present invention relates to the field of medical devices, and in particular to a double-lumen cannula.
插管是体外膜肺氧合(ECMO)系统中直接与人体血管相连的关键组件,是连接ECMO体外循环管路与人体血管的桥梁,对于ECMO系统发挥正常功能起到至关重要的作用。一个ECMO系统中包含两个插管,一个插管是引出人体静脉血,一个插管是将经过ECMO系统氧合之后的动脉血送回人体血管。静脉到静脉的插管方式VV-ECMO是ECMO系统常用于肺功能衰竭患者的插管治疗方式,通常是将一根单腔插管作为引流管,经股静脉穿刺手术后插至下腔静脉临近右心房处,从下腔静脉处把静脉血抽出,经ECMO系统氧合后通过另一根单腔插管经颈内静脉插入至上腔静脉,把氧合后的动脉血输回人体。现有VV-ECMO需要进行两次插管,通过两个体表穿刺孔对两个不同血管进行置管手术,手术复杂度大,也会增加患者感染风险。The cannula is a key component in the extracorporeal membrane oxygenation (ECMO) system that is directly connected to the human blood vessels. It is a bridge connecting the ECMO extracorporeal circulation pipeline and the human blood vessels, and plays a vital role in the normal function of the ECMO system. An ECMO system contains two cannulas, one for drawing out human venous blood, and one for returning arterial blood after oxygenation by the ECMO system to the human blood vessels. The venous-to-venous cannula VV-ECMO is a cannula treatment method commonly used by the ECMO system for patients with pulmonary failure. Usually, a single-lumen cannula is used as a drainage tube. After a femoral vein puncture operation, it is inserted into the inferior vena cava near the right atrium, and venous blood is drawn from the inferior vena cava. After oxygenation by the ECMO system, another single-lumen cannula is inserted into the superior vena cava through the internal jugular vein to return the oxygenated arterial blood to the human body. The existing VV-ECMO requires two cannulas, and two different blood vessels are cannulated through two surface puncture holes. The operation is complicated and will also increase the risk of infection for patients.
一种解决思路是采用双腔插管,将回流管穿入引流管,使用于输送静脉血的引流管路和用于输送动脉血的回流管路集成为一体,仅需仅需一次插管,降低手术复杂度,且减少体表及血管创伤。然而,双腔插管中,引流管路和回路管路占用同一血管路,管路的横截面积受限,难以做到使引流管路与回流管路都有足够的过流断面面积,不能保障引流回流效果。One solution is to use a double-lumen cannula, insert the return tube into the drainage tube, and integrate the drainage line for venous blood and the return line for arterial blood into one. Only one cannula is needed, which reduces the complexity of the operation and reduces the trauma to the body surface and blood vessels. However, in a double-lumen cannula, the drainage line and the return line occupy the same blood vessel, and the cross-sectional area of the line is limited, making it difficult to ensure that both the drainage line and the return line have sufficient flow cross-sectional area, and the drainage and return effect cannot be guaranteed.
发明内容Summary of the invention
针对现有技术存在的不足,本发明的目的在于提供一种双腔插管,使引流管路与回流管路都有足够的过流断面面积,保障引流回流效果。 In view of the deficiencies in the prior art, the object of the present invention is to provide a double-lumen cannula so that both the drainage pipeline and the return pipeline have sufficient flow cross-sectional area to ensure the drainage and return effect.
本公开提供一种双腔插管,包括:The present disclosure provides a double-lumen cannula, comprising:
引流管,具有引流腔;a drainage tube having a drainage lumen;
回流管,穿过所述引流管,包括暴露于所述引流管远端的第一回流管段、内置于所述引流腔的第二回流管段和暴露于所述引流管近端的第三回流管段,A return tube passes through the drainage tube, comprising a first return tube section exposed at the distal end of the drainage tube, a second return tube section built into the drainage cavity, and a third return tube section exposed at the proximal end of the drainage tube,
所述第一回流管段与所述引流管密封连接,所述第二回流管段的近端与所述第三回流管段密封连接,所述第二回流管段的远端的周向上具有固定部和自由部,所述固定部与所述第一回流管段相连,所述自由部具有贴合所述第二回流管段内壁的第一状态和疏离所述第二回流管段内壁的第二状态。The first reflux pipe segment is sealed and connected to the drainage pipe, the proximal end of the second reflux pipe segment is sealed and connected to the third reflux pipe segment, the distal end of the second reflux pipe segment has a fixed portion and a free portion in the circumferential direction, the fixed portion is connected to the first reflux pipe segment, and the free portion has a first state of being in contact with the inner wall of the second reflux pipe segment and a second state of being spaced apart from the inner wall of the second reflux pipe segment.
可选的,所述固定部在所述第二回流管段的远端的周向上的占比小于1/2;Optionally, the fixing portion occupies less than 1/2 of the circumference of the distal end of the second return pipe segment;
所述自由部在所述第二回流管段的远端的周向上的占比大于1/2。The free portion accounts for more than 1/2 of the circumference of the distal end of the second return pipe segment.
可选的,所述引流管的近端设有引流接头,所述第三回流管段上设有回流接头。Optionally, a drainage joint is provided at the proximal end of the drainage tube, and a reflux joint is provided on the third reflux tube section.
可选的,所述第二回流管段为薄壁可形变柔性管;所述第二回流管段的壁厚小于所述第一回流管段的壁厚;所述第二回流管段的壁厚小于所述引流管的壁厚。Optionally, the second return pipe section is a thin-walled deformable flexible tube; the wall thickness of the second return pipe section is smaller than the wall thickness of the first return pipe section; the wall thickness of the second return pipe section is smaller than the wall thickness of the drainage pipe.
可选的,所述第二回流管段的外壁与所述引流管的内壁之间具有空隙;Optionally, there is a gap between the outer wall of the second reflux pipe section and the inner wall of the drainage pipe;
所述引流管远端的侧壁上设有引流孔,所述第一回流管段远端的侧壁上设有回流孔;在插管完成后,所述引流孔位于下腔静脉、上腔静脉或右心房内。A drainage hole is provided on the side wall at the distal end of the drainage tube, and a reflux hole is provided on the side wall at the distal end of the first reflux tube section; after the intubation is completed, the drainage hole is located in the inferior vena cava, the superior vena cava or the right atrium.
可选的,所述引流管的远端设有第一通孔,所述第一回流管段穿过所述第一通孔且与所述第一通孔的孔壁密封连接。Optionally, a first through hole is provided at the distal end of the drainage tube, and the first reflux pipe section passes through the first through hole and is sealed and connected to the hole wall of the first through hole.
可选的,所述第一回流管段的外径小于所述引流管的外径;Optionally, the outer diameter of the first return pipe section is smaller than the outer diameter of the drainage pipe;
所述第一回流管段的外壁与所述引流管的外壁光滑过渡。The outer wall of the first reflux pipe section transitions smoothly with the outer wall of the drainage pipe.
可选的,所述第一回流管段与所述引流管一体成型。Optionally, the first reflux pipe section and the drainage pipe are integrally formed.
可选的,所述引流管近端的侧壁上设有第二通孔,所述回流管穿过所述第二通孔向所述引流管的远端延伸,所述引流管与所述第二通孔的孔壁密封连接。 Optionally, a second through hole is provided on the side wall of the proximal end of the drainage tube, the reflux tube passes through the second through hole and extends toward the distal end of the drainage tube, and the drainage tube is sealedly connected to the hole wall of the second through hole.
可选的,所述第二回流管段与所述第三回流管段之间的夹角大于90°。Optionally, the angle between the second return pipe section and the third return pipe section is greater than 90°.
可选的,所述第二回流管段与所述第三回流管段一体成型。Optionally, the second return pipe section and the third return pipe section are integrally formed.
可选的,所述第一回流管段的管壁内设有第一支撑体;所述第一支撑体用于撑开所述第一回流管段的管壁且使所述第一回流管段可弯曲;Optionally, a first support body is provided in the tube wall of the first reflux pipe section; the first support body is used to prop open the tube wall of the first reflux pipe section and make the first reflux pipe section bendable;
所述第一回流管段上远离所述引流管的一侧的第一支撑体的密度小于靠近所述引流管的一侧的第一支撑体的密度,所述第一回流管段上远离所述引流管的一侧的柔韧性大于靠近所述引流管的一侧的柔韧性。The density of the first support body on the first reflux pipe section away from the drainage pipe is lower than that on the side close to the drainage pipe, and the flexibility of the first reflux pipe section away from the drainage pipe is higher than that on the side close to the drainage pipe.
可选的,所述回流管的长度大于所述引流管的长度,在插管完成后,所述回流管上的回流孔位于左心房内,所述引流管的引流孔位于右心房内。Optionally, the length of the reflux tube is greater than that of the drainage tube. After the intubation is completed, the reflux hole on the reflux tube is located in the left atrium, and the drainage hole of the drainage tube is located in the right atrium.
实施上述方案,具有如下有益效果:The implementation of the above scheme has the following beneficial effects:
本发明提供的双腔插管同时具有引流管和回流管,引流管和回流管集成为一体形成单管,使用时仅需在体表形成一个穿刺孔,出血感染风险比常规的在体表形成两个穿刺孔的方式显著降低。The double-lumen cannula provided by the present invention has both a drainage tube and a reflux tube, which are integrated into a single tube. When used, only one puncture hole needs to be formed on the body surface, and the risk of bleeding and infection is significantly reduced compared with the conventional method of forming two puncture holes on the body surface.
回流管上,第二回流管段与第一回流管段部分连接,在置管时,导芯穿入引流管和第一回流管段,将第二回流管段挤在一侧,由于导芯不用通过第二回流管段,故第二回流管段不必适配导芯尺寸,其管径和壁厚都可以做得更小,减少对引流腔横截面积占用,使引流管内壁与第二回流管段外壁之间的过流断面面积更大。因为通过回流管回输动脉血的血液压力大于通过引流管引流静脉液的血液压力,即使将第二回流管段的管径做小,也不会阻碍动脉血回输,本发明在引流腔截面面积一定的情况下,通过缩小回流管在引流腔中的截面占比,扩大了静脉血引流的过流面积,使引流管与回流管都有足够的过流断面面积,保障引流回流效果。On the reflux tube, the second reflux tube section is partially connected to the first reflux tube section. When the tube is placed, the guide core is inserted into the drainage tube and the first reflux tube section, and the second reflux tube section is squeezed to one side. Since the guide core does not need to pass through the second reflux tube section, the second reflux tube section does not need to adapt to the size of the guide core. Its diameter and wall thickness can be made smaller, reducing the occupation of the drainage cavity cross-sectional area, making the flow cross-sectional area between the inner wall of the drainage tube and the outer wall of the second reflux tube section larger. Because the blood pressure of the arterial blood returned through the reflux tube is greater than the blood pressure of the venous fluid drained through the drainage tube, even if the diameter of the second reflux tube section is made smaller, it will not hinder the return of arterial blood. Under the condition of a certain cross-sectional area of the drainage cavity, the present invention expands the flow area of venous blood drainage by reducing the cross-sectional proportion of the reflux tube in the drainage cavity, so that both the drainage tube and the reflux tube have sufficient flow cross-sectional area to ensure the drainage reflux effect.
图1是本申请实施例提供的双腔插管的主视图;FIG1 is a front view of a double-lumen cannula provided in an embodiment of the present application;
图2是本申请实施例提供的双腔插管的右视图; FIG2 is a right side view of a double lumen cannula provided in an embodiment of the present application;
图3是本申请实施例提供的双腔插管的剖面图;FIG3 is a cross-sectional view of a double-lumen cannula provided in an embodiment of the present application;
图4是图3所示结构的局部结构示意图;FIG4 is a schematic diagram of a partial structure of the structure shown in FIG3 ;
图5是图3所示结构的局部结构示意图;FIG5 is a schematic diagram of a partial structure of the structure shown in FIG3 ;
图6是图5中A部的放大图;FIG6 is an enlarged view of portion A in FIG5 ;
图7是本申请实施例提供的导芯置入双腔插管时的截面图;7 is a cross-sectional view of a guide core provided in an embodiment of the present application when placed into a double-lumen cannula;
图8是本申请实施例提供的导芯撤离双腔插管后的截面图;FIG8 is a cross-sectional view of a core guide provided in an embodiment of the present application after being withdrawn from a double-lumen cannula;
图9是本申请实施例提供的导芯的结构示意图。FIG. 9 is a schematic diagram of the structure of the guide core provided in an embodiment of the present application.
图中:
100引流管,101引流腔,102引流接头,103空隙,104引流孔,105第一
通孔,106第二通孔,107第二支撑体,108引流管过渡段,
200回流管,201第一回流管段,202第二回流管段,203第三回流管段,204
固定部,205自由部,206回流接头,207回流孔,208第一支撑体,209回流管头端,210避让通道,211过流通道,
300导芯,301导芯通孔,302第一导芯段,303第二导芯段,304第三导芯
段,305第四导芯段,306第一卡接部,307第二卡接部,308对接通道;
400导丝。In the figure:
100 drainage tube, 101 drainage cavity, 102 drainage joint, 103 gap, 104 drainage hole, 105 first through hole, 106 second through hole, 107 second support body, 108 drainage tube transition section,
200 reflux pipe, 201 first reflux pipe section, 202 second reflux pipe section, 203 third reflux pipe section, 204
fixed portion, 205 free portion, 206 reflux joint, 207 reflux hole, 208 first support body, 209 reflux pipe head end, 210 avoidance channel, 211 flow channel,
300 core guide, 301 core guide through hole, 302 first core guide segment, 303 second core guide segment, 304 third core guide segment, 305 fourth core guide segment, 306 first clamping portion, 307 second clamping portion, 308 docking channel;
400 guide wire.
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.
因此,以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。 Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步定义和解释。It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not require further definition and explanation in the subsequent drawings.
在本发明的描述中,需要说明的是,术语“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”等仅用于区分描述,而不能理解为指示或暗示相对重要性。在本发明的描述中,除非另有说明,“多个”的含义是两个或两个以上。In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or are the positions or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish descriptions, and cannot be understood as indicating or implying relative importance. In the description of the present invention, unless otherwise specified, "multiple" means two or more.
在本发明的描述中,还需要说明的是,除非另有明确的规定和限定,术语“设置”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
在本发明中,除非另有明确的规定和限定,第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触,也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且,第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方,或仅仅表示第一特征水平高度小于第二特征。In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.
下面详细描述本发明的实施例,实施例的示例在附图中示出,其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的,仅用于解释本发明,而不能理解为对本发明的限制。 Embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.
本实施例提供一种双腔插管,请参见图1-图8,双腔插管包括引流管100和回流管200,引流管100内部具有引流腔101,回流管200穿过引流管100,回流管200包括第一回流管段201、第二回流管段202和第三回流管段203,第一回流管段201暴露于引流管100的远端,第三回流管段203暴露于引流管100的近端,第二回流管段202内置在引流腔101中,第二回流管段202的两端分别对接第三回流管段203和第一回流管段201。回流管200的长度大于引流管100的长度。引流管100的近端设有引流接头102,第三回流管段203上设有回流接头206。请参见图4和图5,引流管100远端的侧壁上设有引流孔104,第一回流管段201远端的侧壁上设有回流孔207。第二回流管段202的外壁与引流管100的内壁之间留有空隙103,允许从引流孔104进入的静脉血通过该空隙103流向引流接头102。The present embodiment provides a double-lumen cannula, as shown in Figures 1 to 8, the double-lumen cannula includes a drainage tube 100 and a return tube 200, the drainage tube 100 has a drainage cavity 101 inside, the return tube 200 passes through the drainage tube 100, the return tube 200 includes a first return tube segment 201, a second return tube segment 202 and a third return tube segment 203, the first return tube segment 201 is exposed at the distal end of the drainage tube 100, the third return tube segment 203 is exposed at the proximal end of the drainage tube 100, the second return tube segment 202 is built in the drainage cavity 101, and the two ends of the second return tube segment 202 are respectively connected to the third return tube segment 203 and the first return tube segment 201. The length of the return tube 200 is greater than the length of the drainage tube 100. The proximal end of the drainage tube 100 is provided with a drainage joint 102, and the third return tube segment 203 is provided with a return joint 206. 4 and 5 , a drainage hole 104 is provided on the side wall at the distal end of the drainage tube 100, and a reflux hole 207 is provided on the side wall at the distal end of the first reflux tube section 201. A gap 103 is left between the outer wall of the second reflux tube section 202 and the inner wall of the drainage tube 100, allowing venous blood entering from the drainage hole 104 to flow to the drainage connector 102 through the gap 103.
需要说明的是,双腔插管上引流孔104用于将体内静脉血液引出体外,回流孔207用于将富氧动脉血回输体内,引流孔104和回流孔207的位置可根据具体的使用部位和体格大小来设计,例如根据静脉血的预定位置与回输动脉血的预定位置之间的距离,改变引流孔104和回流孔207之间的距离,确保引流孔104和回流孔207能够准确送达指定位置。It should be noted that the drainage hole 104 on the double-lumen cannula is used to drain venous blood from the body, and the reflux hole 207 is used to return oxygen-rich arterial blood to the body. The positions of the drainage hole 104 and the reflux hole 207 can be designed according to the specific use site and body size. For example, according to the distance between the predetermined position of venous blood and the predetermined position of the returned arterial blood, the distance between the drainage hole 104 and the reflux hole 207 can be changed to ensure that the drainage hole 104 and the reflux hole 207 can be accurately delivered to the designated position.
需要说明的是,双腔插管的引流孔104位于下腔静脉、上腔静脉或右心房内,用于将静脉血吸入双腔插管的引流腔101并引至体外,然后经过氧合器氧合并排除二氧化碳处理后成富氧的动脉血,最终再由离心泵依次经回流接头206、第三回流管段203、第二回流管段202和第一回流管段201直接灌注入左心房,可减轻心肺负担,用于心肺支持。示例性的,在插管完成后,回流管200上的回流孔207位于左心房内,引流管100的引流孔104位于右心房内。It should be noted that the drainage hole 104 of the double-lumen cannula is located in the inferior vena cava, the superior vena cava or the right atrium, and is used to draw venous blood into the drainage cavity 101 of the double-lumen cannula and lead it to the outside of the body, and then pass through the oxygenator to oxygenate and remove carbon dioxide to become oxygen-rich arterial blood, and finally directly perfuse into the left atrium through the return joint 206, the third return pipe segment 203, the second return pipe segment 202 and the first return pipe segment 201 by the centrifugal pump in sequence, which can reduce the burden on the heart and lungs and is used for cardiopulmonary support. Exemplarily, after the cannula is completed, the return hole 207 on the return pipe 200 is located in the left atrium, and the drainage hole 104 of the drainage tube 100 is located in the right atrium.
其中,第一回流管段201与引流管100密封连接,第二回流管段202的近端与第三回流管段203密封连接。第二回流管段202的远端的周向上具有固定部204和自由部205,固定部204与第一回流管段201相连,自由部205具有贴合第二 回流管段202内壁的第一状态和疏离第二回流管段202内壁的第二状态。自由部205处于第一状态下时,第一回流管段201、第二回流管段202和第三回流管段203依次连通形成过流通道211,用于引流动脉血液,如图8所示。自由部处于第二状态下时,第二回流管段202的外壁与第一回流管段201的内壁之间形成避让通道210,允许用于放送双腔插管的导芯300通过,如图7所示。The first reflux pipe section 201 is sealed and connected to the drainage pipe 100, and the proximal end of the second reflux pipe section 202 is sealed and connected to the third reflux pipe section 203. The distal end of the second reflux pipe section 202 has a fixed portion 204 and a free portion 205 in the circumferential direction. The fixed portion 204 is connected to the first reflux pipe section 201, and the free portion 205 has a second reflux pipe section 203. The first state of the inner wall of the return pipe segment 202 and the second state of the inner wall of the second return pipe segment 202. When the free portion 205 is in the first state, the first return pipe segment 201, the second return pipe segment 202 and the third return pipe segment 203 are connected in sequence to form a flow channel 211 for draining arterial blood, as shown in Figure 8. When the free portion is in the second state, an avoidance channel 210 is formed between the outer wall of the second return pipe segment 202 and the inner wall of the first return pipe segment 201, allowing the guide core 300 used for the double-lumen cannula to pass through, as shown in Figure 7.
具体的,固定部204在第二回流管段202的远端的周向上的占比小于1/2,自由部205在第二回流管段202的远端的周向上的占比大于1/2,以确保自由部205形变后第二回流管段202的外壁与第一回流管段201的内壁之间有足够大的通道供导芯300通过。在一个可能的实现方式中,固定部204在第二回流管段202的远端的周向上的占比为1/3,自由部205在第二回流管段202的远端的周向上的占比为2/3,固定部204粘接在第二回流管段202的内壁上。Specifically, the fixed portion 204 accounts for less than 1/2 of the circumference of the distal end of the second return pipe segment 202, and the free portion 205 accounts for more than 1/2 of the circumference of the distal end of the second return pipe segment 202, so as to ensure that after the deformation of the free portion 205, there is a large enough channel between the outer wall of the second return pipe segment 202 and the inner wall of the first return pipe segment 201 for the guide core 300 to pass through. In a possible implementation, the fixed portion 204 accounts for 1/3 of the circumference of the distal end of the second return pipe segment 202, and the free portion 205 accounts for 2/3 of the circumference of the distal end of the second return pipe segment 202, and the fixed portion 204 is bonded to the inner wall of the second return pipe segment 202.
第二回流管段202为薄壁可形变柔性管,第二回流管段202的自由部205受导芯300挤压后能够向固定部204靠近。第二回流管段202的壁厚小于第一回流管段201的壁厚;第二回流管段202的壁厚小于引流管100的壁厚。第一回流管段201的管壁内设有第一支撑体208,第一支撑体208用于撑开第一回流管段201的管壁且使第一回流管段201可弯曲。引流管100的管壁内设有第二支撑体107,第二支撑体107用于撑开引流管100管壁且使引流管100可弯曲。其中,第一支撑体208和第二支撑体107可以为螺旋形结构或者网罩结构的支撑体,例如支撑弹簧。The second return pipe section 202 is a thin-walled deformable flexible tube, and the free portion 205 of the second return pipe section 202 can approach the fixed portion 204 after being squeezed by the guide core 300. The wall thickness of the second return pipe section 202 is less than that of the first return pipe section 201; the wall thickness of the second return pipe section 202 is less than that of the drainage tube 100. A first support body 208 is provided in the tube wall of the first return pipe section 201, and the first support body 208 is used to prop open the tube wall of the first return pipe section 201 and make the first return pipe section 201 bendable. A second support body 107 is provided in the tube wall of the drainage tube 100, and the second support body 107 is used to prop open the tube wall of the drainage tube 100 and make the drainage tube 100 bendable. Among them, the first support body 208 and the second support body 107 can be support bodies with a spiral structure or a mesh structure, such as a support spring.
第一回流管段201和引流管100要置入体内,第一回流管段201和引流管100具有一定的支撑强度和柔韧性,能够沿着完全的血管管路,到达预定位置。第二回流管段202内置在引流腔101中,不需要直接接触血管壁,本实施例在第二回流管段202内不设置支撑体,在过流截面面积相同的情况下,可以将第二回流管段202的管壁做薄,缩小回流管200在引流腔101中的截面占比,扩大静脉血引流的过流面积。 The first return pipe section 201 and the drainage tube 100 are to be placed in the body. The first return pipe section 201 and the drainage tube 100 have certain support strength and flexibility, and can reach the predetermined position along the complete blood vessel pipeline. The second return pipe section 202 is built into the drainage cavity 101 and does not need to directly contact the blood vessel wall. In this embodiment, no support body is set in the second return pipe section 202. Under the condition of the same flow cross-sectional area, the wall of the second return pipe section 202 can be made thinner, reducing the cross-sectional area of the return pipe 200 in the drainage cavity 101, and expanding the flow area of venous blood drainage.
在一个可能的实现方式中,第一回流管段201上远离引流管100的一侧的第一支撑体208的密度小于靠近引流管100的一侧的第一支撑体208的密度,第一回流管段201上远离引流管100的一侧的柔韧性大于靠近引流管100的一侧的柔韧性。本实施例通过调整第二支撑体107在第二回流管段202上不同位置处的疏密程度,使第二回流管段202不同位置对应不同的弯曲强度,第二支撑体107越密,则弯曲强度越大。以第二支撑体107为弹簧为例,在第二回流管段202上远离引流管100的位置设置较为稀疏的弹簧,在第二回流管段202上靠近引流管100的位置设置较为密集的弹簧,则第二回流管段202上靠近引流管100一侧的弯曲强度大于第二回流管段202上远离引流管100一侧的弯曲强度,如此,可以使第二回流管段202的远端柔韧性更好,降低第二回流管段202的远端穿过三尖瓣及肺动脉瓣的放置难度。In a possible implementation, the density of the first support 208 on the side of the first return pipe section 201 away from the drainage pipe 100 is less than the density of the first support 208 on the side close to the drainage pipe 100, and the flexibility of the side of the first return pipe section 201 away from the drainage pipe 100 is greater than the flexibility of the side close to the drainage pipe 100. In this embodiment, the density of the second support 107 at different positions on the second return pipe section 202 is adjusted so that different positions of the second return pipe section 202 correspond to different bending strengths, and the denser the second support 107, the greater the bending strength. Taking the second support body 107 as an example, relatively sparse springs are set on the second return pipe segment 202 away from the drainage tube 100, and relatively dense springs are set on the second return pipe segment 202 close to the drainage tube 100. Then, the bending strength of the second return pipe segment 202 close to the drainage tube 100 is greater than the bending strength of the second return pipe segment 202 away from the drainage tube 100. In this way, the distal end of the second return pipe segment 202 can be made more flexible, reducing the difficulty of placing the distal end of the second return pipe segment 202 through the tricuspid valve and the pulmonary valve.
请参见图3,第一回流管段201的外径小于所述引流管100的外径,一方面,第一回流管段201作为整个双腔插管的头端部位,减小第一回流管段201的外径,有利于其在血管中顺畅通行,同时由于第一回流管段201用于输送动脉血,动脉血输送时压力较大,即使做小其外径减小其内径,动脉血也能在第一回流管段201内顺畅流通;另一方面,将第一回流管段201外径减小,还可以减小其在插入过程中对血管壁及心脏瓣膜等组织的创伤。Please refer to Figure 3. The outer diameter of the first return tube segment 201 is smaller than the outer diameter of the drainage tube 100. On the one hand, the first return tube segment 201 serves as the head end of the entire double-lumen cannula. Reducing the outer diameter of the first return tube segment 201 is beneficial to its smooth passage in the blood vessel. At the same time, since the first return tube segment 201 is used to transport arterial blood, the pressure of arterial blood is relatively high during transportation. Even if its outer diameter and inner diameter are reduced, the arterial blood can still flow smoothly in the first return tube segment 201. On the other hand, reducing the outer diameter of the first return tube segment 201 can also reduce the trauma to the blood vessel wall, heart valve and other tissues during the insertion process.
第一回流管段201的外壁与引流管100的外壁光滑过渡,回流管200与引流管100远端结合处没有台阶面,将插管置入血管时不会对血管壁造成损伤。The outer wall of the first reflux tube section 201 transitions smoothly with the outer wall of the drainage tube 100 , and there is no step surface at the distal joint of the reflux tube 200 and the drainage tube 100 , so that the blood vessel wall will not be damaged when the cannula is inserted into the blood vessel.
在一种可能的实现方式中,引流管100的远端设有第一通孔105,第一回流管段201穿过第一通孔105且与第一通孔105的孔壁密封连接。在另一种可能的实现方式中,第一回流管段201与引流管100一体成型。In one possible implementation, the distal end of the drainage tube 100 is provided with a first through hole 105, and the first return pipe section 201 passes through the first through hole 105 and is sealed and connected to the hole wall of the first through hole 105. In another possible implementation, the first return pipe section 201 and the drainage tube 100 are integrally formed.
请参见图3,引流管100近端的侧壁上还设有第二通孔106,回流管200穿过第二通孔106向引流管100的远端延伸,引流管100与第二通孔106的孔壁密封连接。第二回流管段202与第三回流管段203之间的夹角大于90°。本实施例 中,回流管200倾斜一定角度穿入引流腔101,避免血液在回流管200中急速转向造成血液细胞损伤。其中,第二回流管段202与第三回流管段203一体成型。当然,第二回流管段202与第三回流管段203也可以分体成型后密封连接。Please refer to FIG3 , a second through hole 106 is further provided on the side wall of the proximal end of the drainage tube 100, and the return pipe 200 extends through the second through hole 106 to the distal end of the drainage tube 100, and the drainage tube 100 is sealed and connected to the hole wall of the second through hole 106. The angle between the second return pipe section 202 and the third return pipe section 203 is greater than 90°. In the embodiment, the reflux pipe 200 is tilted at a certain angle to penetrate the drainage cavity 101 to prevent the blood from turning rapidly in the reflux pipe 200 and causing damage to blood cells. The second reflux pipe section 202 and the third reflux pipe section 203 are integrally formed. Of course, the second reflux pipe section 202 and the third reflux pipe section 203 can also be separately formed and then sealed and connected.
本发明提供的双腔插管同时具有引流管100和回流管200,引流管100和回流管200集成为一体形成单管,使用时仅需在体表形成一个穿刺孔,出血感染风险比常规的在体表形成两个穿刺孔的方式显著降低。The double-lumen cannula provided by the present invention has both a drainage tube 100 and a return tube 200. The drainage tube 100 and the return tube 200 are integrated into a single tube. When used, only one puncture hole needs to be formed on the body surface. The risk of bleeding infection is significantly reduced compared with the conventional method of forming two puncture holes on the body surface.
回流管200上,第二回流管段202与第一回流管段201部分连接,在置管时,导芯300穿入引流管100和第一回流管段201,将第二回流管段202挤在一侧,由于导芯300不用通过第二回流管段202,故第二回流管段202不必适配导芯300尺寸,其管径和壁厚都可以做得更小,减少对引流腔101横截面积占用,使引流管100内壁与第二回流管段202外壁之间的过流断面面积更大。因为通过回流管200回输动脉血的血液压力大于通过引流管100引流静脉液的血液压力,即使将第二回流管段202的管径做小,也不会阻碍动脉血回输,本发明在引流腔101截面面积一定的情况下,通过缩小回流管200在引流腔101中的截面占比,扩大了静脉血引流的过流面积,使引流管100与回流管200都有足够的过流断面面积,保障引流回流效果。On the reflux pipe 200, the second reflux pipe section 202 is partially connected to the first reflux pipe section 201. When the tube is placed, the guide core 300 passes through the drainage tube 100 and the first reflux pipe section 201, and the second reflux pipe section 202 is squeezed to one side. Since the guide core 300 does not need to pass through the second reflux pipe section 202, the second reflux pipe section 202 does not need to adapt to the size of the guide core 300. Its tube diameter and wall thickness can be made smaller, reducing the cross-sectional area occupied by the drainage cavity 101, so that the flow cross-sectional area between the inner wall of the drainage tube 100 and the outer wall of the second reflux pipe section 202 is larger. Because the blood pressure of the arterial blood returned through the reflux tube 200 is greater than the blood pressure of the venous fluid drained through the drainage tube 100, even if the diameter of the second reflux tube section 202 is reduced, it will not hinder the return of arterial blood. In the present invention, when the cross-sectional area of the drainage cavity 101 is constant, the cross-sectional proportion of the reflux tube 200 in the drainage cavity 101 is reduced, thereby expanding the flow area of venous blood drainage, so that both the drainage tube 100 and the reflux tube 200 have sufficient flow cross-sectional area to ensure the drainage reflux effect.
本实施例提供的双腔导管利用导芯引导其置入体内。请参见图9,所述导芯300内部具有贯穿所述导芯300两端的导芯通孔301,所述导芯通孔301用于穿设导丝400,所述导芯通孔301包括对接通道308,所述对接通道308的直径与所述导丝400的直径匹配。可选的,对接通道308的直径略大于导丝400的直径,或者对接通道308的直径等于导丝400的直径。所述导芯300的外壁具有卡接部,当所述导芯300置入所述双腔插管中时,所述卡接部与所述引流腔101的内壁和/或所述第一回流管段201的内壁贴合。The double-lumen catheter provided in this embodiment is inserted into the body by using a guide core. Please refer to Figure 9. The guide core 300 has a guide core through hole 301 that runs through both ends of the guide core 300. The guide core through hole 301 is used to pass the guide wire 400. The guide core through hole 301 includes a docking channel 308, and the diameter of the docking channel 308 matches the diameter of the guide wire 400. Optionally, the diameter of the docking channel 308 is slightly larger than the diameter of the guide wire 400, or the diameter of the docking channel 308 is equal to the diameter of the guide wire 400. The outer wall of the guide core 300 has a clamping portion. When the guide core 300 is inserted into the double-lumen cannula, the clamping portion fits with the inner wall of the drainage cavity 101 and/or the inner wall of the first reflux pipe section 201.
在一种可能的实现方式中,所述导芯300包括依次相连的第一导芯段302、第二导芯段303、第三导芯段304和第四导芯段305,所述导芯通孔301贯通所 述第一导芯段302、所述第二导芯段303、所述第三导芯段304和所述第四导芯段305。所述第四导芯段305的外径大于所述第二导芯段303的外径,所述第三导芯段304的外径从靠近所述第四导芯段305的一侧向靠近所述第二导芯段303的一侧逐渐减小,所述第一导芯段302的外径从靠近所述第二导芯段303的一侧向远离所述第二导芯段303的一侧逐渐减小。所述对接通道308设于所述第一导芯段内。所述卡接部包括第一卡接部306和第二卡接部307,所述第一卡接部306设于所述第一导芯段302上,所述第二卡接部307设于所述第三导芯段304上。示例性的,所述第一卡接部306可以位于所述第一导芯段302上与所述第二导芯段303相连的位置,所述第二卡接部307可以位于所述第三导芯段304上与所述第四导芯段305相连的位置。In a possible implementation, the guide core 300 includes a first guide core segment 302, a second guide core segment 303, a third guide core segment 304 and a fourth guide core segment 305 connected in sequence, and the guide core through hole 301 passes through the first guide core segment 302, the second guide core segment 303, the third guide core segment 304 and the fourth guide core segment 305. The first core guide segment 302, the second core guide segment 303, the third core guide segment 304 and the fourth core guide segment 305. The outer diameter of the fourth core guide segment 305 is greater than the outer diameter of the second core guide segment 303, the outer diameter of the third core guide segment 304 gradually decreases from the side close to the fourth core guide segment 305 to the side close to the second core guide segment 303, and the outer diameter of the first core guide segment 302 gradually decreases from the side close to the second core guide segment 303 to the side away from the second core guide segment 303. The docking channel 308 is provided in the first core guide segment. The clamping portion includes a first clamping portion 306 and a second clamping portion 307, the first clamping portion 306 is provided on the first core guide segment 302, and the second clamping portion 307 is provided on the third core guide segment 304. Exemplarily, the first clamping portion 306 may be located on the first core segment 302 at a position connected to the second core segment 303 , and the second clamping portion 307 may be located on the third core segment 304 at a position connected to the fourth core segment 305 .
在一种可能的实现方式中,所述引流管包括引流管过渡段108,所述引流管过渡段108连接所述第一回流管段201,并且,所述引流管过渡段108的外径和内径均从远离所述第一回流管段201的一侧向靠近所述第一回流管段201的一侧逐渐减小。请参见图3和图4,所述第一回流管段201远离所述第二回流管段202的一侧具有回流管头端209,所述回流管头端209的内径从靠近所述第二回流管段202的一侧向远离所述第二回流管段202的一侧逐渐减小。当所述导芯300置入所述双腔插管时,所述第一导芯段302部分伸出所述第一回流管段201,所述第一卡接部306贴合所述回流管头端的内壁,所述第二卡接部307贴合所述引流管过渡段的内壁,以将导芯300定位于双腔插管内。需要注意的时,导芯300与双腔插管的贴合面不宜过大,如果贴合面过大,则双腔插管与导芯300之间的摩擦力增大,不利于导芯300撤离。In a possible implementation, the drainage pipe includes a drainage pipe transition section 108, the drainage pipe transition section 108 is connected to the first return pipe section 201, and the outer diameter and the inner diameter of the drainage pipe transition section 108 are gradually reduced from the side away from the first return pipe section 201 to the side close to the first return pipe section 201. Referring to Figures 3 and 4, the first return pipe section 201 has a return pipe head end 209 on the side away from the second return pipe section 202, and the inner diameter of the return pipe head end 209 is gradually reduced from the side close to the second return pipe section 202 to the side away from the second return pipe section 202. When the core guide 300 is inserted into the double-lumen cannula, the first core guide segment 302 partially extends out of the first return tube segment 201, the first clamping portion 306 fits against the inner wall of the return tube head end, and the second clamping portion 307 fits against the inner wall of the drainage tube transition section, so as to position the core guide 300 in the double-lumen cannula. It should be noted that the fitting surface between the core guide 300 and the double-lumen cannula should not be too large. If the fitting surface is too large, the friction between the double-lumen cannula and the core guide 300 will increase, which is not conducive to the withdrawal of the core guide 300.
本实施例的插管的置入过程包括:The insertion process of the cannula in this embodiment includes:
1、将导芯300依次穿过引流接头102、引流腔101和第一回流管段201,此时导芯300将第二回流管段303挤在一侧,导芯300的第一导芯段302的前端穿出第一回流管段201,第一导芯段302后端的第一卡接部306与第一回流管段201 上的回流管头端209的内壁贴合,第三导芯段304上的第二卡接部307与引流管过渡段108的内壁贴合。第一导芯段302处于导芯300的头端,第四导芯段305处于导芯300的尾端,在导芯300沿着头端所指方向移动时,导芯300始终套设在双腔插管中且可带动双腔插管移动,在导芯300沿着尾端所指方向移动时,导芯300可退出双腔插管。1. The guide core 300 is passed through the drainage joint 102, the drainage cavity 101 and the first return pipe section 201 in sequence. At this time, the guide core 300 squeezes the second return pipe section 303 to one side, and the front end of the first guide core section 302 of the guide core 300 passes through the first return pipe section 201. The first clamping portion 306 at the rear end of the first guide core section 302 is connected to the first return pipe section 201. The inner wall of the return tube head end 209 on the guide core 300 is in contact with the inner wall of the drainage tube transition section 108, and the second clamping portion 307 on the third guide core segment 304 is in contact with the inner wall of the drainage tube transition section 108. The first guide core segment 302 is at the head end of the guide core 300, and the fourth guide core segment 305 is at the tail end of the guide core 300. When the guide core 300 moves along the direction indicated by the head end, the guide core 300 is always sleeved in the double-lumen cannula and can drive the double-lumen cannula to move. When the guide core 300 moves along the direction indicated by the tail end, the guide core 300 can exit the double-lumen cannula.
2、将导丝400的头端经体表穿刺孔沿血管送入指定位置(例如左心房),导丝400尾端露于体表外。2. The head end of the guide wire 400 is sent into a designated position (such as the left atrium) along the blood vessel through the puncture hole on the body surface, and the tail end of the guide wire 400 is exposed outside the body surface.
3、将导丝400的尾端依次穿过导芯300的第一导芯段302、第二导芯段303、第三导芯段304和第四导芯段305,导丝400的外壁与对接通道308的内壁贴合,导丝400的前端伸出第一导芯段302,导丝400的尾端伸出第四导芯段305。3. Pass the tail end of the guide wire 400 through the first guide core segment 302, the second guide core segment 303, the third guide core segment 304 and the fourth guide core segment 305 of the guide core 300 in sequence, the outer wall of the guide wire 400 fits with the inner wall of the docking channel 308, the front end of the guide wire 400 extends out of the first guide core segment 302, and the tail end of the guide wire 400 extends out of the fourth guide core segment 305.
4、利用导丝400引导导芯300和双腔插管进入血管,直至双腔插管的回流孔207和引流孔104到达指定位置,然后将导丝400和导芯300从双腔插管中撤离出来,完成双腔插管的置管。4. Use the guide wire 400 to guide the guide core 300 and the double-lumen cannula into the blood vessel until the reflux hole 207 and the drainage hole 104 of the double-lumen cannula reach the designated position, and then withdraw the guide wire 400 and the guide core 300 from the double-lumen cannula to complete the placement of the double-lumen cannula.
在使用双腔插管导流血液时,由于从回流管200回输至体内的动脉血的血液压力远大于从引流管100流出的静脉血的血液压力,故第二回流管段303能够在动脉血冲击下舒展开,使第二回流管303的外壁紧贴第一回流管段201的内壁,形成动脉血过流通道211,确保动脉血顺畅地从回流孔207流出。When using a double-lumen cannula to guide blood, since the blood pressure of the arterial blood returned to the body from the reflux tube 200 is much greater than the blood pressure of the venous blood flowing out of the drainage tube 100, the second reflux tube section 303 can expand under the impact of the arterial blood, so that the outer wall of the second reflux tube 303 is close to the inner wall of the first reflux tube section 201, forming an arterial blood flow channel 211, ensuring that the arterial blood flows smoothly from the reflux hole 207.
注意,上述仅为本发明的较佳实施例及所运用技术原理。本领域技术人员会理解,本发明不限于这里的特定实施例,对本领域技术人员来说能够进行各种明显的变化、重新调整和替代而不会脱离本发明的保护范围。因此,虽然通过以上实施例对本发明进行了较为详细的说明,但是本发明不仅仅限于以上实施例,在不脱离本发明构思的情况下,还可以包括更多其他等效实施例,而本发明的范围由所附的权利要求范围决定。 Note that the above are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art will understand that the present invention is not limited to the specific embodiments herein, and that various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and the scope of the present invention is determined by the scope of the appended claims.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311085113.1A CN116870340B (en) | 2023-08-28 | 2023-08-28 | Double-cavity cannula |
| CN202311085113.1 | 2023-08-28 |
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| WO2025043883A1 true WO2025043883A1 (en) | 2025-03-06 |
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| Application Number | Title | Priority Date | Filing Date |
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| PCT/CN2023/130432 Pending WO2025043883A1 (en) | 2023-08-28 | 2023-11-08 | Dual lumen cannula |
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| WO (1) | WO2025043883A1 (en) |
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| CN116870340B (en) * | 2023-08-28 | 2024-01-30 | 江苏赛腾医疗科技有限公司 | Double-cavity cannula |
| CN116899086A (en) * | 2023-08-28 | 2023-10-20 | 江苏赛腾医疗科技有限公司 | Cannula suit |
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Also Published As
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| CN116870340B (en) | 2024-01-30 |
| CN116870340A (en) | 2023-10-13 |
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