Saline irrigation and torque-modified temporary pacing catheter

Abstract

This invention discloses a saline perfusion and torque-modified temporary pacing catheter, comprising a catheter with a first balloon at its distal end and a connector at its proximal end. The first balloon is configured as both a buoy balloon and a positioning balloon. When inflated with gas, it functions as a buoy balloon; when inflated with liquid, it functions as a positioning balloon. Electrodes are mounted on the catheter for pacing or mapping. Compared to existing technologies, by providing a second balloon on the catheter that can function as both a buoy balloon and a positioning balloon, and by inflating the first balloon with gas to function as a buoy balloon and inflating it with liquid to function as a positioning balloon, the second balloon can be secured within the ventricle after inflation. This effectively reduces pacing interruptions caused by blood disturbance and positions the electrodes in the pacing target area, reducing the burden on the patient.

Description

Technical Field

[0001] This utility model relates to a medical device, and more particularly to a saline infusion and torque-modified temporary pacing catheter capable of positioning electrodes. Background Technology

[0002] Current research indicates that bradycardia and brief pauses in heartbeat can cause acute hemodynamic changes that endanger life. Temporary pacemakers can effectively regulate heart rate and maintain a stable heartbeat.

[0003] Currently, the most widely used temporary pacing electrode catheters in clinical practice are divided into conventional temporary pacing electrode catheters and floating temporary pacing electrode catheters. Physicians need to choose the appropriate catheter based on the patient's indications and the usage scenario. Conventional temporary pacing electrode catheters are advanced to the apex of the right ventricle under X-ray guidance. Floating temporary pacing electrode catheters are typically used without X-ray fluoroscopy (though X-ray fluoroscopy guidance can be used as needed), relying on the buoyancy of the distal balloon to float from a peripheral vein to the right atrium, cross the tricuspid valve, and be advanced to the apex of the right ventricle. Based on experience, pacing catheters are generally placed for 1-2 weeks, with a maximum duration of no more than 1 month. Due to blood flow and patient movement, the pacing electrode of existing pacing catheters can easily detach from the target position, leading to pacing interruption. In such cases, the operator needs to reposition the catheter. Utility Model Content

[0004] The purpose of this invention is to provide a saline perfusion and torque-modified temporary pacing catheter. The technical problem to be solved is to enable the catheter to have a positioning function so as to ensure that the electrode is fixed in the pacing target area and to avoid blood disturbance causing the electrode to detach from the target position.

[0005] To solve the above problems, the present invention adopts the following technical solution: a saline perfusion and torque-modified temporary pacing catheter, including a catheter, a first balloon at the distal end of the catheter, and a connector at the proximal end of the catheter. The first balloon is configured as a buoy balloon and a positioning balloon. When the first balloon is filled with gas, it acts as a buoy balloon. When the first balloon is filled with liquid, it acts as a positioning balloon. Electrodes are provided on the catheter for pacing or mapping.

[0006] Furthermore, the catheter is provided with a second balloon that can move along the catheter axis. The second balloon is configured as a positioning balloon to replace the first balloon as a positioning balloon, thereby positioning the catheter in the ventricle.

[0007] Furthermore, the proximal end of the second balloon is provided with a push rod having an inner lumen. The proximal end of the push rod passes through the inner lumen of the catheter and extends out from the proximal end of the connector and connects with a third Luer connector provided on the proximal end of the connector. A collar is provided at the distal end of the second balloon and is fitted onto the catheter.

[0008] Furthermore, the collar is coated with a developing coating.

[0009] Furthermore, the length of the second balloon 6 is 2mm to 15mm.

[0010] Furthermore, the electrode includes a ring electrode and / or a terminal electrode, with the ring electrodes spaced apart on the distal end of the catheter and the terminal electrode disposed on the distal end of the catheter.

[0011] Furthermore, the first balloon is disposed at the distal end of the catheter, and ring electrodes are disposed at intervals at the distal end of the catheter.

[0012] Furthermore, the electrode includes a ring electrode and a terminal electrode, with the ring electrodes spaced apart on the distal end of the catheter body and the terminal electrode disposed on the distal end of the catheter.

[0013] Furthermore, the catheter includes a first catheter body and a second catheter body with different diameters. The diameter of the second catheter body is smaller than that of the first catheter body. The second catheter body is located at the distal end of the first catheter body. The proximal end of the first catheter body is connected to the distal end of the connector. A first balloon is located on the second catheter body, and the second balloon can move axially on the second catheter body.

[0014] Furthermore, the hardness of the first catheter body gradually decreases from the proximal end to the distal end.

[0015] Compared with the prior art, this invention provides a second balloon on the catheter that can serve as both a buoy balloon and a positioning balloon. The first balloon is filled with gas to function as a buoy balloon, and the second balloon is filled with liquid to function as a positioning balloon. Once inflated, the second balloon can be locked in the ventricle, thereby effectively reducing pacing interruptions caused by blood disturbances and positioning the electrode in the pacing target area, thus reducing the burden on the patient. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the first embodiment of this utility model.

[0017] Figure 2 This is a schematic diagram of the structure of the second catheter body according to the first embodiment of this utility model.

[0018] Figure 3 This is a schematic diagram of the structure of the first catheter body in the first embodiment of this utility model.

[0019] Figure 4 This is a schematic diagram of the second balloon after inflation according to the first embodiment of this utility model.

[0020] Figure 5 This is a schematic diagram of the connection between the first balloon and the second catheter body in the first embodiment of this utility model.

[0021] Figure 6 This is a structural schematic diagram of the second embodiment of this utility model.

[0022] Figure 7 This is a schematic diagram of the structure of the first catheter body in the second embodiment of this utility model.

[0023] Figure 8 This is a schematic diagram of the relationship between the second balloon and the second catheter body in the first embodiment of this utility model.

[0024] Figure 9 yes Figure 8 A cross-sectional view along the AA direction.

[0025] Figure 10 This is a schematic diagram of the connector structure in the first embodiment of this invention.

[0026] Figure 11 This is a schematic diagram of the first catheter cavity arrangement in the first embodiment of this utility model. Detailed Implementation

[0027] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0028] In this invention, the distal end refers to the end furthest from the surgeon; the proximal end refers to the end closest to the surgeon.

[0029] like Figure 1 As shown, this utility model discloses a saline perfusion and torque-modified temporary pacing catheter, comprising a catheter, a first balloon 5 serving as a buoy balloon at the distal end of the catheter, a connector 8 at the proximal end of the catheter, a first Luer connector 61, a second Luer connector 51, a third Luer connector 71, a first insertion pin 111, and a second insertion pin 211 at the proximal end of the connector 8, and a second balloon 6 movable along the catheter axis on the catheter. The second balloon 6 is located on the outer periphery of the catheter and serves as a positioning balloon, thereby controlling the position of the catheter within the ventricle. Positioning is performed by placing ring electrodes 1 at intervals on the distal end of the catheter body and end electrodes 2 at the distal end of the catheter. The ring electrodes 1 are connected to the first insertion pin 111 via the first wire 11, and the end electrodes 2 are connected to the second insertion pin 211 via the second wire 21. The first Luer connector 61 is used to inject contrast agent, the second Luer connector 51 is used to inflate the first balloon 5, and the third Luer connector 71 is used to inflate the second balloon 6. The first wire 11 and the second wire 21 are covered with an insulating layer to prevent leakage.

[0030] The medium filled into the second balloon 6 is liquid, preferably physiological saline, while the medium filled into the first balloon 5 is gas, so that it can float when the blood flows, drifting in the direction of blood flow and carrying the electrodes to the ventricle.

[0031] like Figure 1 As shown, the catheter includes a first catheter body 4 and a second catheter body 3 with different diameters. The diameter of the second catheter body 3 is smaller than that of the first catheter body 4. The second catheter body 3 is located at the distal end of the first catheter body 4. The proximal end of the first catheter body 4 is connected to the distal end of the connector 8. The first balloon 5 is located on the second catheter body 3. The second balloon 6 can move axially on the second catheter body 3.

[0032] like Figure 2 As shown, the second catheter body 3 has a second catheter cavity 32 inside. The first balloon 5 is disposed on the tube body at the distal end of the second catheter body 3 and surrounds the second catheter body 3. The proximal end of the first balloon 5 is sealed to the outer wall of the tube body of the second catheter 3, and the distal end of the first balloon 5 is sealed to the outer wall of the distal tube body of the second catheter body 3. The tube body of the second catheter body 3 located on the first balloon 5 has a channel 31 that connects the first balloon 5 and the second catheter cavity 32, so that the medium can enter the first balloon 5 through the second catheter cavity 32 and the channel 31 to inflate it. The end electrode 2 is located at the distal end of the second catheter body 3 and is fixed by welding. The ring electrode 1 is sleeved and welded onto this part of the second catheter body 3 near the proximal end of the first balloon 5. The ring electrode 1 is spaced apart along the axial direction of the second catheter body 3. The end electrode 2 is made of platinum-iridium alloy or gold, with a rounded end. Its electrode thickness is 0.2mm to 5mm, preferably 1mm to 4mm, and its outer diameter matches the outer diameter of the tube body of the second catheter body 3. The ring electrode 1 is made of platinum-iridium alloy or gold. The wall thickness of the ring electrode 1 is 0.01mm to 0.1mm, preferably 0.03mm to 0.07mm, and its outer diameter matches the outer diameter of the tube body of the second catheter body 3. The ring electrode 1 is nested to form a smooth transition with the outer wall surface of the tube body of the second catheter body 3. The number of ring electrodes 1 is 1 to 10, preferably 1 to 3.

[0033] In this invention, a limiting protrusion 34 formed by sealing adhesive is provided at the sealing connection between the distal end of the first balloon 5 and the tube wall of the second catheter 3. Figure 2 As shown), to prevent the second balloon 6 from detaching from the second catheter body 3 during axial movement, the limiting protrusion 34 is close to the end electrode 2; by limiting the size of the glue sealing ring, the second balloon 6 can smoothly pass through the proximal seal of the first balloon 5.

[0034] In this invention, the second conduit body 3 is made of soft materials such as block polyether amide resin (PEBAX), polyurethane, block polyamide, or nylon. Its outer diameter is 0.4mm to 1.5mm, preferably 0.9mm to 1.2mm, its inner diameter is 0.12mm to 0.55mm, preferably 0.20mm to 0.45mm, and its length is 20mm to 1000mm, preferably 150mm to 300mm. The first conductor 11 and the second conductor 21 are copper wires with a diameter of 0.01mm to 0.55mm, preferably 0.02mm to 0.09mm. The copper wires are covered with an insulating layer of polyimide (PI) or nylon, etc., with an insulation strength of more than 500V, preferably more than 2000V.

[0035] like Figure 3 As shown, the first catheter body 4 includes three cavities: a first cavity 41, a second cavity 44, and a third cavity 43. The first cavity 41 is located on the centerline of the first catheter body 4, while the second cavity 44 and the third cavity 43 are offset from the centerline. The second cavity 44 penetrates the first catheter body 4, and a through-hole is provided on the transition surface between the first catheter body 4 and the second catheter body 4. Figure 11 As shown), a push rod 42 is provided in the second cavity 44. The proximal end of the push rod 42 extends out from the proximal end of the second cavity 44 and connects to the third Luer connector 71. The distal end of the push rod 42 extends out from the through-hole and connects to the second balloon 6. The push rod 42 has a cavity communicating with the third Luer connector 71 and the second balloon 6. A sealing ring 421 is provided on the proximal end of the push rod 42. A connecting head cavity 81 communicating with the second cavity 44 is provided on the connecting head 8. The proximal end of the push rod 42 passes through the connecting head cavity 81. An annular groove 82 for accommodating the sealing ring 421 is provided at the proximal end of the connecting head cavity 81. The sealing ring 421 is placed in the annular groove 82. Figure 10 As shown), when the push rod 42 moves axially, the sealing ring 421 will not move with the push rod 41. The first cavity 41 is connected to the second catheter cavity 32. The first lead 11 and the second lead 21 are connected to the first pin 111 and the second pin 211 on the connector 8 after passing through the second catheter cavity 32 and the first cavity 41, respectively. Alternatively, a cavity can be set in the wall of the first catheter body 4 and the second catheter body 3 specifically for the routing of the first lead 11 and the second lead 21. The proximal end of the first cavity 41 is sealed and connected to the second Luer connector 51. The proximal end of the third cavity 43 is sealed and connected to the first Luer connector 61. The distal end of the third cavity 43 penetrates the first catheter body 4, and a through-hole is set on the transition surface between the first catheter body 4 and the second catheter body 3 to allow the contrast agent to be introduced into the blood vessel from the through-hole.

[0036] The second catheter body 4 is made of block polyetheramide resin (PEBAX), polyurethane, block polyamide, or nylon, with an outer diameter of 1.2 mm to 2.8 mm, preferably 1.6 mm to 2.3 mm; the size of the inner lumen 41 is consistent with the inner diameter of the tube body 3, i.e., the size of the catheter channel 32; the inner diameter of the third channel 43 is 0.12 mm to 0.55 mm, preferably 0.20 mm to 0.45 mm; the inner diameter of the first channel 41 is 0.20 mm to 0.65 mm, preferably 0.30 mm to 0.55 mm; the inner diameter of the second channel 44 is 0.22 mm to 0.69 mm, preferably 0.32 mm to 0.55 mm; the length of the second catheter body 4 is 300 mm to 1100 mm, preferably 500 mm to 800 mm. The first catheter body 4 adopts a multi-hardness segment design. By adding appropriate amounts of barium sulfate, embedding woven stainless steel wire mesh of different densities inside the tube wall, and modifying materials, the hardness gradually decreases from the proximal end to the distal end, thus forming different hardness segments. The above structure enables the catheter to have strong torque and pushing force, which is conducive to adjusting the state of the catheter. The catheter has excellent flexibility and can automatically float to the target area using the power provided by blood flow.

[0037] like Figure 3 , Figure 8 and Figure 9 As shown, the proximal end of the push rod 42 passes through the second cavity 44 and extends from the proximal end of the connector 8, connecting to the third Luer connector 71. The third Luer connector 71 can be used to push the push rod 42. A collar 63 is provided at the distal end of the second balloon 6. The collar 63 is fitted onto the catheter. The inner diameter of the collar 63 is larger than the outer diameter of the part after the proximal end of the first balloon 5 is sealed with glue, and smaller than the outer diameter of the limiting protrusion 34 formed by the glue sealing ring at the distal end of the balloon 5, so as to limit the collar 63 by the limiting protrusion 34, thereby limiting the second balloon 6. The push rod 42 is made of soft materials such as polyurethane, block polyamide or nylon, with a wall thickness of 0.02mm to 0.22mm, preferably 0.10mm to 0.18mm, and an outer diameter of 0.18mm to 0.63mm, preferably 0.28mm to 0.53mm. The length is set according to the total length of the catheter to ensure that the push rod can move axially on the catheter.

[0038] The collar 63 is coated with a medical radiopaque coating made of nickel-titanium material. The collar 63 restricts the movement of the second balloon 6, allowing it to move only along the axial direction of the second catheter body 3. The second balloon 6 is made of a flexible and soft material such as latex, rubber, or nylon, with a wall thickness of 0.02mm to 0.22mm, preferably 0.10mm to 0.18mm, and a length of 2mm to 15mm, preferably 5mm to 8mm. Before inflation, the second balloon 6 is a cylindrical shape with its inner walls attached together.

[0039] The first balloon 5 is made of elastic and soft materials such as latex, rubber or nylon, with a wall thickness of 0.02mm to 0.4mm, preferably 0.15mm to 0.25mm, and a length of 3mm to 15mm, preferably 5mm to 8mm. Before being inflated, its outer diameter is adapted to the outer diameter of the second catheter body 3.

[0040] like Figure 2 As shown, the first balloon 5 is fitted onto the second catheter body 3, and its proximal and distal ends are sealed to the outer wall of the second catheter body 3 with glue. Of course, at the corresponding position, a groove 33 can be provided on the outer wall of the second catheter body 3. The depth of the groove 33 is adapted to the wall thickness of the first balloon 5 so that before the first balloon 5 is inflated, it can form a flat surface with the outer wall of the second catheter body 3, which is convenient for insertion into the body.

[0041] like Figures 5 to 7 As shown, in another embodiment of this utility model, the first balloon 5 can be disposed at the distal end of the second catheter body 3. In this structure, the end electrode 2 and the second balloon 6 are not disposed. The first balloon 5 is constructed as a dual-purpose balloon, which serves as a buoy balloon when filled with gas and as a positioning balloon when filled with liquid. The annular electrode 2 is disposed on the second catheter body 3 at the proximal end of the first balloon 5. Before inflation, the first balloon 5 is a cap-shaped structure that fits over the distal end of the second catheter body 3 and is sealed by adhesive bonding. The second cavity 44, the third Luer connector 71, and the push rod 42 are eliminated. Only the first cavity 41 and the third cavity 43 are retained on the first catheter body 4. The distal end of the first cavity 41 is sealed to the proximal end of the second catheter cavity 32, and the distal end of the second catheter cavity 32 is connected to the first balloon 5. This simplifies the catheter structure and achieves the multi-purpose function of a single balloon without increasing additional costs.

[0042] The method of using this utility model is as follows: After the second catheter body 3 enters the vein, gas is injected quantitatively using a syringe. The gas passes through the second Luer connector 51, the first cavity 41 in the first catheter body 4, the second catheter cavity 32, and the channel 31 to reach the first balloon 5. After the first balloon 5 is inflated, the catheter is advanced to the right ventricle by the power of blood flow. During delivery, the contrast agent can reach the blood vessel through the first Luer connector 61 and the third cavity 43 within the first catheter body 4, achieving contrast agent-assisted navigation and precisely and conveniently adjusting the state of the second catheter body 3. Depending on clinical needs, this third cavity 43 can also deliver other fluids. After reaching the ventricle, a measured amount of gas is injected through the third Luer connector 71. The gas passes through the inner lumen of the push rod 42 within the second cavity 44 of the first catheter body 4, reaching the second balloon 6. The second balloon 6 is inflated and pushed to a suitable position, for example, between the ring electrode 1 and the terminal electrode 2. At this point, the gas inside the second balloon 6 is released, and the catheter position is adjusted. After confirming the pacing target area, saline is injected through the inner lumen of the push rod 42. The inflated second balloon 6 is compressed by chordae tendineae and other strip-shaped tissues, achieving positioning and avoiding disturbance to the second catheter body 3 caused by blood flow. Figure 4 As shown: the second balloon 6 deforms laterally after being compressed by the strip-shaped tissue, encasing the body of the second catheter 3. If necessary, a guidewire can also be used to intervene in the second balloon 6 through the third Luer connector 71 and the inner lumen of the push rod 42. The push rod itself is relatively flexible, while the guidewire can increase its rigidity for easier advancement. The real-time position of the second balloon 6 can be confirmed using the collar 63 carrying contrast material under X-ray or with the aid of contrast agent.

[0043] The usage method when the second balloon 6 is not set is roughly the same as the above method, except that when gas and liquid are introduced, it is achieved through the second Luer connector 51, the first cavity 41, and the second catheter cavity 32. There is no need to push the balloon with the push rod 42 to position it.

[0044] This invention can also achieve navigation by injecting contrast agent through the first Luer connector 61, making it easier to control the direction of catheter advancement; the strong torque and pushing force of the first catheter body 4, combined with the buoyancy of the first balloon 5, can be used to accelerate the speed of reaching the right ventricle; the second balloon 6, which is infused with physiological saline, or the first balloon 5, which is used as a positioning balloon, can be used to restrict the second balloon 6, which is infused with physiological saline, or to prevent the electrodes of the second catheter body 3 from falling off the target position with the flow of blood.

Claims

1. A saline perfusion and torque-modified temporary pacing catheter, comprising a catheter, a first balloon (5) at the distal end of the catheter, and a connector (8) at the proximal end of the catheter, characterized in that: The first balloon (5) is configured as a buoy balloon and a positioning balloon. When the first balloon (5) is filled with gas, it acts as a buoy balloon. When the first balloon (5) is filled with liquid, it acts as a positioning balloon. Electrodes are provided on the catheter for pacing or mapping.

2. The saline perfusion and torque-modified temporary pacing catheter according to claim 1, characterized in that: The catheter is provided with a second balloon (6) that can move along the catheter axis. The second balloon (6) is configured as a positioning balloon to replace the first balloon (5) as a positioning balloon, thereby positioning the catheter in the ventricle.

3. The saline perfusion and torque-modified temporary pacing catheter according to claim 2, characterized in that: The second balloon (6) has a push rod (42) with an inner lumen at its proximal end. The proximal end of the push rod (42) passes through the inner lumen of the catheter and extends out from the proximal end of the connector (8) and connects to the third Luer connector (71) located at the proximal end of the connector (8). The second balloon (6) has a collar (63) at its distal end, which is fitted onto the catheter.

4. The saline perfusion and torque-modified temporary pacing catheter according to claim 3, characterized in that: The collar (63) is coated with a developing coating.

5. The saline perfusion and torque-modified temporary pacing catheter according to claim 4, characterized in that: The length of the second balloon (6) is 2mm to 15mm.

6. The saline perfusion and torque-modified temporary pacing catheter according to claim 1, characterized in that: The electrodes include ring electrodes (1) and / or end electrodes (2), with the ring electrodes (1) spaced apart on the distal end of the catheter and the end electrodes (2) located at the distal end of the catheter.

7. The saline perfusion and torque-modified temporary pacing catheter according to claim 6, characterized in that: The first balloon (5) is located at the distal end of the catheter, and a ring electrode (1) is provided at a distance from the distal end of the catheter.

8. The saline perfusion and torque-modified temporary pacing catheter according to claim 2, characterized in that: The electrode includes a ring electrode (1) and an end electrode (2). The ring electrodes (1) are spaced apart on the distal end of the catheter, and the end electrodes (2) are located at the distal end of the catheter.

9. The saline perfusion and torque-modified temporary pacing catheter according to any one of claims 1-8, characterized in that: The catheter includes a first catheter body (4) and a second catheter body (3) with different diameters. The diameter of the second catheter body (3) is smaller than that of the first catheter body (4). The second catheter body (3) is located at the distal end of the first catheter body (4). The proximal end of the first catheter body (4) is connected to the distal end of the connector (8). The first balloon (5) is located on the second catheter body (3). The second balloon (6) can move axially on the second catheter body (3).

10. The saline perfusion and torque-modified temporary pacing catheter according to claim 9, characterized in that: The hardness of the first catheter body (4) gradually decreases from the proximal end to the distal end.

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