The application is a divisional application of China patent application with the name of guiding suction catheter and catheter system with the guiding suction catheter, of which the application date is 2024, 5, 27 and the application number is 2024106678746.
Disclosure of Invention
A first object of the present invention is to provide a guide suction catheter in which a suction passage is smooth and the influence of a guide wire on the effective suction area of a lumen can be avoided.
A second object of the present invention is to provide a catheter system having a guide suction catheter by which a smooth suction path is ensured and an influence of a guide wire on an effective suction area of a lumen is avoided.
In order to achieve the first object, the invention provides a guiding suction catheter, which comprises a catheter main body, a delivery piece, a delivery handle, an anchoring balloon and a wire guide tube, wherein an extension channel for conveying medical instruments is arranged in the catheter main body, an introduction port communicated with the extension channel is arranged at the proximal end of the catheter main body, the distal end of the delivery piece is connected with the proximal end of the catheter main body, a filling channel is arranged in the delivery piece, the distal end of the delivery handle is connected with the proximal end of the delivery piece, the inner cavity of the delivery handle is communicated with the filling channel, the anchoring balloon is sleeved on the catheter main body and is positioned near the proximal end of the catheter main body, the inner cavity of the anchoring balloon is communicated with the filling channel, the wire guide tube is connected with the catheter main body along the catheter direction of the catheter main body, the proximal end of the wire guide tube is positioned at one side of the distal end of the anchoring balloon, the distal end of the wire guide tube extends to the distal end of the catheter main body, and a wire guide wire is arranged in the wire guide tube to pass through the wire guide cavity in the wire guide tube.
Compared with the prior art, the guide suction catheter has the advantages that the guide wire pipes are connected in parallel in the catheter direction of the catheter main body, so that the guide wires can pass through the guide wire cavity of the guide wire pipes without occupying the area of the extension channel of the catheter main body, the suction passage for suction through the extension channel of the catheter main body is smooth, the effective suction area is relatively large, the influence of the guide wires on the effective suction area of the catheter can be avoided, the suction effect is improved, and meanwhile, the guide wires passing through the guide wire cavity can also guide and anchor the catheter main body, so that the guide suction catheter can be accurately conveyed to a target area.
Preferably, the guidewire lumen is disposed within the catheter body.
Preferably, the distal end of the catheter body is a beveled suction port.
Preferably, the catheter body comprises an inner layer, a middle reinforcing layer and an outer layer which are sequentially arranged from inside to outside.
Preferably, the hardness of the outer layer decreases from the proximal end to the distal end of the catheter body.
Preferably, the distal end of the delivery member is fixed in the wall of the catheter body, a through hole is arranged at a position of the delivery member close to the proximal end of the catheter body, and the through hole is communicated between the filling channel and the inner cavity of the anchoring balloon.
Preferably, the interior of the delivery member is hollow, the filling channel is formed within the hollow, and the distal end of the delivery member extends to a location corresponding to the anchoring balloon.
Preferably, the inlet of the catheter body has a bevel structure.
In order to achieve the second object, the invention provides a catheter system, which comprises a guiding catheter, a guide wire and the guiding suction catheter, wherein a guiding channel is arranged in the guiding catheter, the guiding suction catheter slides in the guiding channel when the anchoring balloon is not filled, the guide wire movably passes through the guiding channel and the guide wire cavity, the anchoring balloon is expanded and then abuts against the inner wall of the guiding channel when the anchoring balloon is filled, and the extension channel is communicated with the guiding channel.
Compared with the prior art, the catheter system provided by the invention has the guide suction catheter, and the guide suction catheter is connected with the guide wire tube in parallel in the catheter direction of the catheter main body, so that the guide wire can pass through the guide wire cavity of the guide wire tube without occupying the area of the extension channel of the catheter main body, the suction passage for sucking through the guide channel and the extension channel is smooth, the effective suction area is relatively large, the influence of the guide wire on the effective suction area of the cavity can be avoided, the suction effect is improved, and meanwhile, the guide wire passing through the guide wire cavity can also guide and anchor the catheter main body, so that the guide suction catheter can be accurately conveyed to a target area.
Preferably, the guiding suction catheter is inserted into the guiding channel, the distal end of the catheter body penetrates out of the distal end of the guiding channel, the proximal end of the catheter body is positioned in the guiding channel, and the proximal end of the delivery piece is positioned outside the proximal end of the guiding channel.
Detailed Description
In order to describe the technical content and constructional features of the present invention in detail, the following description will be made with reference to the embodiments in conjunction with the accompanying drawings. It should be noted that, the "proximal end" in the above description and the following description generally refers to an end of the medical device that is close to the operator during normal operation, and the "distal end" generally refers to an end of the medical device that first enters the patient during normal operation.
Referring to fig. 1-13, a catheter system 200 of the present invention includes a guide catheter 201, a guidewire 202, and a guide aspiration catheter 100. The guiding suction catheter 100 comprises a catheter main body 1, a delivery piece 2, a delivery handle 3, an anchoring balloon 4 and a wire guide tube 5, wherein an extension channel 11 for conveying medical instruments is arranged in the catheter main body 1, an introduction port 12 communicated with the extension channel 11 is arranged at the proximal end of the catheter main body 1, the distal end of the delivery piece 2 is connected with the proximal end of the catheter main body 1, a filling channel 21 is arranged in the delivery piece 2, the distal end of the delivery handle 3 is connected with the proximal end of the delivery piece 2, the inner cavity of the delivery handle 3 is communicated with the filling channel 21, the anchoring balloon 4 is sleeved on the catheter main body 1 and is positioned near the proximal end of the catheter main body 1, the inner cavity of the anchoring balloon 4 is communicated with the filling channel 21, the wire guide tube 5 is connected with the catheter main body 1 in parallel along the catheter direction of the catheter main body 1, the proximal end of the wire guide tube 5 is positioned at one side of the distal end of the anchoring balloon 4, the distal end of the wire guide tube 5 extends to the distal end of the catheter main body 1, and a wire guide cavity 51 for allowing a wire 202 to penetrate is arranged in the wire guide tube 5. The guiding catheter 201 is internally provided with a guiding channel 201a, when the anchoring balloon 4 is not filled, the guiding aspiration catheter 100 slides in the guiding channel 201a, the guide wire 202 movably penetrates through the guiding channel 201a and the guide wire cavity 51, when the anchoring balloon 4 is filled, the anchoring balloon 4 is expanded and is abutted against the inner wall of the guiding channel 201a and the guide wire 202, and the extension channel 11 is communicated with the guiding channel 201 a.
Specifically, the guide suction catheter 100 is inserted into the guide channel 201a, and the distal end of the catheter body 1 is threaded out from the distal end of the guide channel 201a, the proximal end of the catheter body 1 is positioned in the guide channel 201a, the proximal end of the delivery member 2 is positioned outside the proximal end of the guide channel 201a, and the introduction port 12 communicates the extension channel 11 with the guide channel 201 a.
Referring to fig. 5 and 6, in one embodiment, the guide wire tube 5 is disposed on the outer wall of the catheter body 1, but not limited thereto.
Referring to fig. 1 and 13, in one embodiment, the distal end of the catheter body 1 is a beveled suction port. By setting the distal end of the catheter main body 1 to be a beveled suction port, the contact area of the distal end of the catheter main body 1 with the thrombus 300 is increased, the capturing ability of the thrombus 300 is improved, and the suction efficiency is improved. The axial angle between the beveled suction port and the catheter body 1 may be 0-90 degrees, but is not limited thereto.
Referring to fig. 3, in one embodiment, the catheter body 1 includes an inner layer 13, a middle reinforcing layer 14, and an outer layer 15, which are disposed in order from the inside to the outside. The catheter body 1 has a three-layer composite structure, and can provide strong support, pressure resistance and fracture resistance.
In one embodiment, the inner layer 13 is made of polytetrafluoroethylene or linear low density polyethylene, so as to provide lower friction for other instruments passing through the extension channel 11 in the inner layer 13, the middle reinforcing layer 14 is a stainless steel woven mesh layer or a spring layer, so that the catheter main body 1 has strong negative pressure resistance and strong support property to improve the folding resistance and torsion control property of the catheter main body 1, the outer layer 15 is made of one or more of polyether front end polyamide, nylon and polyurethane elastomer, and the outer surface has smoother appearance and feel, fully protects blood vessels, avoids thrombus 300, interlayers and the like.
In one embodiment, the hardness of the outer layer 15 decreases sequentially from the proximal end to the distal end of the catheter body 1. The catheter main body 1 is not abrupt, the requirement of pushing the catheter main body 1 in the blood vessel of a human body is better met, a doctor can operate more accurately and conveniently, and the pain of a patient in the operation process can be reduced. Further, the outer layer 15 is also coated with a hydrophilic layer, and the head end of the catheter body 1 is soft and noninvasive. This design ensures good support, handling and lubricity of the catheter body 1.
In one embodiment, as shown in fig. 5 and 6, the catheter body 1 and the guide wire 5 are separately provided, and the catheter body 1 and the guide wire 5 are bonded, welded, and connected together by a connector. It is understood that it is within the scope of the present application to provide the guidewire lumen 51 and the elongate channel 11 in a split arrangement. Referring to fig. 7 to 9, in other embodiments, the catheter body 1 and the guide wire tube 5 may be integrally disposed, such that the guide wire lumen 51 and the extension channel 11 are divided, the guide wire lumen 51 is preferentially disposed in the catheter body 1, and the cross-sectional shape of the extension channel 11 may be variously modified, for example, as shown in fig. 7 to 9, but not limited thereto.
Referring to fig. 1 to 4 and 10, in one embodiment, the distal end of the delivery member 2 is fixed in the wall of the catheter body 1, and a through hole 22 is disposed at a position of the delivery member 2 near the proximal end of the catheter body 1, and the through hole 22 is communicated between the filling channel 21 and the inner cavity of the anchoring balloon 4. The inner cavity of the delivery handle 3, the filling channel 21 of the delivery piece 2 and the inner cavity of the anchoring balloon 4 are mutually communicated to form a single-cavity channel, a doctor can connect media such as injection fluid at the delivery handle 3, and the media such as the fluid can enter the anchoring balloon 4 through the inner cavity of the delivery handle 3, the filling channel 21 and the through holes 22 of the delivery piece 2, so that the anchoring balloon 4 is pressurized, the anchoring balloon 4 is rapidly anchored in the guiding channel 201a of the guiding catheter 201 and is blocked, the guiding suction catheter 100 is connected with the guiding catheter 201 in a sealing way, the suction pressure is not reduced when thrombus or plaque is sucked later, and the guiding suction catheter 100 can be prevented from moving. The anchoring balloon 4 may anchor the guidewire 202 while filling, preventing the guidewire 202 from moving back and forth during physician procedures, avoiding possible vascular damage due to movement of the guide aspiration catheter 100 or guidewire 202. Also, since the distal end of the delivery member 2 is fixed within the wall of the catheter body 1, the delivery member 2 can be hidden at the middle of the material of the catheter body 1 so that the delivery member 2 does not damage the blood vessel. Specifically, the delivery member 2 is provided with a plurality of through holes 22, and the through holes 22 are distributed at the middle position of the balloon.
Referring to fig. 1-4 and 10, in one embodiment, the interior of the delivery member 2 is hollow, and the filling channel 21 is formed in the hollow, with the distal end of the delivery member 2 extending to a position corresponding to the anchoring balloon 4. However, this is not a limitation, and in other embodiments, the proximal end of the delivery member 2 is hollow, and the filling channel 21 is formed in the hollow.
In another embodiment, the delivery member 2 extends distally, and the distal end of the delivery member 2 is of solid construction, so that the pushing force can be transmitted well by arranging the distal end of the delivery member 2 in a solid construction. Further, the outer diameter of the hollow structure 23 is larger than the outer diameter of the solid structure 24, thereby ensuring the strength of the push rod delivery member 2 at the location of the hollow structure 23.
During interventional therapy, an operator can directly hold the delivery handle 3 to stably push the catheter body 1 in the human body, and the delivery member 2 provides good supporting force and pushing force for guiding the suction catheter 100 so as to ensure smooth operation. Wherein, delivery member 2 can be made of stainless steel, and the surface is polished to improve the safety of the interventional procedure.
Referring to fig. 1 and fig. 10 to 12, in an embodiment, the inlet 12 of the catheter body 1 has a bevel structure, so that the guiding suction catheter 100 of the present invention has better pushability. The axial angle between the bevel structure and the catheter body 1 may be 0-90 degrees, but is not limited thereto.
The introduction port 12 can be used as a channel for the entrance and exit of an instrument and can also be used as a channel for sucking thrombus 300, such as an external catheter or a stent, and the like can enter the extension channel 11 of the catheter main body 1 from the introduction port 12 and move to the distal end of the catheter main body 1 in a penetrating way, so that the guiding suction catheter 100 can be used as a quick exchange catheter, and the introduction port 12 can be connected with a syringe through the guiding catheter 201, so that the thrombus 300 can be sucked through the syringe.
Referring to fig. 1 and 3, in one embodiment, the anchoring balloon 4 is vacuum-flattened and attached to the outer layer 15 of the catheter body 1, the distal end of the anchoring balloon 4 is tightly welded or bonded to the outer layer 15 of the catheter body 1, so as to form a sealed end, the proximal end of the anchoring balloon 4 is tightly welded to the outer layer 15 of the catheter and the distal end of the delivery member 2, and the welded or bonded part of the two ends of the whole anchoring balloon 4 has smooth transition, no obvious concave-convex feel, smoother entering into other channel instruments and low resistance. Specifically, the anchoring balloon 4 may be a compliant balloon, which herein refers to an anchoring balloon 4 that may increase in diameter and volume as filling pressure increases after expanding to a predetermined diameter. The anchoring balloon 4 may be made of nylon, polyethylene, polyurethane or polyethylene terephthalate material.
In one embodiment, the outer layer 15 of the catheter body 1 is provided with a developing element 6 at a position close to the anchoring balloon 4, but is not limited thereto. Further, the distal end of the catheter body 1 may also be provided with a developing element 6, but is not limited thereto. During a contrast operation, the developing element 6 may display a black image, providing the operator with positional information. The developing element 6 may be made of an X-ray opaque developing material, which is one or more of gold, tungsten, platinum iridium alloy. The developing element 6 may be a developing ring, a cylindrical spiral developing coil, or a developing coating layer coated on the side wall of the catheter main body 1. In particular, the developing element 6 is preferably a developing ring, which can help the operator to quickly catch the positions of the catheter body 1 and the anchoring balloon 4.
Referring to fig. 11 and 12, in one embodiment, a catheter seat 203 is disposed at a proximal end of the guiding catheter 201, the catheter seat 203 has a first port 203a and a second port 203b, the first port 203a and the second port 203b are respectively communicated with the guiding channel 201a, the guide wire 202 and the guiding aspiration catheter 100 are inserted into the first port 203a, and the proximal end of the delivery member 2 is disposed outside the catheter seat 203, and the second port 203b is used for fluid delivery or aspiration.
In one embodiment, after the guide aspiration catheter 100 of the present invention has completed the anchoring operation, contrast media or other fluid medium may be injected through the catheter hub 203 on the guide catheter 201, which medium may flow down the guide channel 201a of the guide catheter 201 into the elongate channel 11 of the catheter body 1 where the guide aspiration catheter 100 is to be performed, performing super-selective imaging, or other targeted therapy.
In one embodiment, after the guide aspiration catheter 100 of the present invention has completed the anchoring operation, the associated aspiration instrument may be used to aspirate thrombus 300, calcified plaque, etc. from the blood vessel through the catheter hub 203 on the guide catheter 201. The thrombus 300 or calcified plaque or the like may be returned to the guide channel 201a of the guide catheter 201 along the extension channel 11 of the catheter body 1 of the guide suction catheter 100 by negative pressure, and finally withdrawn outside the body.
Referring to fig. 1-13, taking a small vessel access for aspiration of thrombus 300 as an example, the catheter system 200 of the present invention operates as follows:
The thrombus 300 is delivered to the guide catheter 201 to a larger vessel adjacent to the small vessel, and the guide wire 202 is delivered to the thrombus 300 of the small vessel along the first port 203a of the catheter holder 203 at the proximal end of the guide catheter 201. The guide wire tube 5 is fed along the guide wire 202 to guide the aspiration catheter 100, and the guide aspiration catheter 100 is extended into the guide catheter 201 from the first port 203a of the catheter holder 203 at the proximal end of the guide catheter 201. The distal end of the catheter body 1 of the guide suction catheter 100 is exposed from the distal end of the guide catheter 201, the proximal end of the catheter body 1 is located in the guide channel 201a, one end of the delivery member 2 is located in the guide channel 201a, the other end of the delivery member 2 is exposed from the first port 203a of the catheter hub 203, and the delivery handle 3 is located outside the catheter hub 203. Under the guidance of the guide wire 202, the catheter body 1 enters the finger anchor, and since the delivery member 2 is contained in the catheter body 1, the force can be applied by the delivery member 2, so that the guide catheter 201 easily enters the branched blood vessel and the narrow blood vessel.
A transmission channel is established, wherein the anchoring balloon 4 is filled through the inner cavity of the delivery handle 3 and the filling channel 21 in the delivery piece 2, the anchoring balloon 4 is anchored in the guiding channel 201a after being expanded, the anchoring balloon 4 seals the gap between the guiding catheter 201 and the catheter main body 1, and the guiding channel 201a is communicated with the catheter cavity.
Delivering contrast agent/drug by blocking the first port 203a of the guide catheter 201 extending beyond the delivery member 2 at the catheter hub 203, delivering contrast agent/drug at the second port 203b of the catheter hub 203, flowing along the guide channel 201a into the elongate channel 11 of the catheter body 1, and then out the distal end of the catheter body 1, the contrast agent/drug flowing toward the distal end of the small vessel, thereby performing super-selective contrast/targeted delivery.
And (3) externally connecting an aspirator to aspirate thrombus 300 and plaque, namely plugging a first port 203a extending out of the delivery member 2 at the catheter seat 203 of the guiding catheter 201, connecting the aspirator to a second port 203b of the catheter seat 203, and aspirating thrombus 300 and plaque at the distal end of the catheter main body 1. The thrombus 300 or calcified plaque or the like flows back along the extension channel 11 of the catheter body 1 to the guide channel 201a under negative pressure until being withdrawn outside the body.
Withdrawal of the guidewire 202 (or guiding the aspiration catheter 100) withdraws the medium within the anchoring balloon 4 using a pressure pump under negative pressure. Under X-ray fluoroscopy, it is determined that the anchoring balloon 4 is deflated and no medium remains, and the guidewire 202 (or the guide aspiration catheter 100) is retracted entirely until it exits the body.
In summary, the catheter system 200 of the present invention has the guide suction catheter 100, and the guide suction catheter 100 is connected with the guide wire tube 5 in parallel in the catheter direction of the catheter body 1, so that the guide wire 202 can pass through the guide wire lumen 51 of the guide wire tube 5 without occupying the area of the extension channel 11 of the catheter body 1, the suction passage for suction through the guide channel 201a and the extension channel 11 is smooth, the effective suction area is relatively large, the influence of the guide wire 202 on the effective suction area of the lumen can be avoided, the suction effect is improved, and meanwhile, the guide wire 202 passing through the guide wire lumen 51 can also guide and anchor the catheter body 1, so that the guide suction catheter 100 can be accurately conveyed to the target area. In addition, since the guide wire 202 does not occupy the area of the extension channel 11 of the catheter body 1, the effective aspiration area is relatively large, aspiration capability is better for the large thrombus 300, and complications are reduced. In addition, the guide suction catheter 100 of the present invention can be used as a guide instrument for deep insertion into a more distant position of a blood vessel, and can also realize the functions of thrombus 300 and plaque suction, reduce the event of thrombus caused by the suction of the thrombus 300, reduce the exchange between instruments, and improve the operation efficiency.
The foregoing disclosure is only illustrative of the preferred embodiments of the present invention and is not to be construed as limiting the scope of the invention, which is defined by the appended claims.