CN106264709B

CN106264709B - Guide catheter

Info

Publication number: CN106264709B
Application number: CN201510288331.4A
Authority: CN
Inventors: 王铮; 张清淳; 梁波; 孙杰; 孙毅勇; 谭家宏
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Hongdian Medical Technology Co ltd
Priority date: 2015-05-29
Filing date: 2015-05-29
Publication date: 2021-03-19
Anticipated expiration: 2035-05-29
Also published as: CN106264709A

Abstract

The invention discloses a guide catheter, comprising: the catheter tube body comprises a catheter head end, a catheter deflection section, a fixed bending section, a catheter main body and a catheter handle, and is connected with the catheter tube body; the catheter comprises a catheter body, a catheter handle and a guide wire, wherein a pull wire is arranged in the catheter body, a first knob and a second knob are arranged on the catheter handle, the first knob is connected with the catheter body and used for controlling the catheter body to rotate along a central shaft of a catheter main body, and the second knob is connected with the pull wire and used for controlling deflection of a deflectable section of the catheter. The guide catheter provided by the invention has the fixed bend and the adjustable bend simultaneously, and can realize various bending shapes according to clinical requirements, so that the adjustable bend can be adjusted through the control handle, the catheter body can freely rotate along the central shaft, the arrival rate and the sticking force of the catheter in the renal artery ablation can be increased, the success rate of the operation is increased, and the time and the risk of the operation are reduced.

Description

Guide catheter

Technical Field

The invention relates to a medical electrode catheter, in particular to a guide catheter.

Background

Percutaneous renal artery ablation can be used to treat refractory hypertension. The operation is to melt by introducing a radio frequency ablation catheter to the renal artery through the skin, and to melt and destroy the sympathetic nerve on the renal artery, so that the blood pressure is reduced. The mode of singly adopting the radio frequency ablation catheter has more defects, such as long in-place time of the catheter, low in ablation target point in-place rate, small in contact force with tissues, complex in bending control, difficult to form an effective ablation focus and the like.

These problems are best addressed by the introduction of a guiding catheter, which reduces the time of the procedure and improves the safety and effectiveness of the procedure. The guiding catheters on the market are generally used for intracardiac treatment, simply modified, e.g. by shortening the sheath length, for renal artery ablation. The products do not follow the actual start of renal artery ablation operation, and cannot meet the related requirements, so that the arrival rate of the catheter is low and the contact force is small. Therefore, there is a need to design ablation catheters adapted for their application to address the characteristics of renal artery ablation.

Disclosure of Invention

The invention aims to solve the technical problem of providing a guide catheter which simultaneously has a fixed bend and an adjustable bend, can adjust the adjustable bend through a control handle, can enable a catheter body to freely rotate along a central shaft, can increase the arrival rate and the sticking force of the catheter in the renal artery ablation, can increase the success rate of the operation, and can reduce the time and the risk of the operation.

The present invention is directed to solving the above-mentioned problems, and an aspect of the present invention is to provide a guide catheter, including: the catheter tube body comprises a catheter head end, a catheter deflection section, a fixed bending section, a catheter main body and a catheter handle, and is connected with the catheter tube body; the catheter comprises a catheter body, a catheter handle and a guide wire, wherein a pull wire is arranged in the catheter body, a first knob and a second knob are arranged on the catheter handle, the first knob is connected with the catheter body and used for controlling the catheter body to rotate along a central shaft of a catheter main body, and the second knob is connected with the pull wire and used for controlling deflection of a deflectable section of the catheter.

Further, the first knob is a hollow cylinder, and the inner surface of the cylinder and the outer surface of the catheter tube body are fixed with each other.

Further, be provided with internal thread pole, external screw thread pole, gear, first rack and second rack in the pipe handle, the second knob with internal thread pole is fixed continuous, internal thread pole has the internal thread, external screw thread pole has the external screw thread, the internal thread with external screw thread threaded connection, external screw thread pole with first rack is fixed continuous, first rack, gear and second rack mesh in proper order and link to each other, the quantity of acting as go-between is two, fixes respectively on first rack and the second rack.

Further, the pull wire is fixed on the first rack and the second rack through screws or gluing.

Furthermore, the catheter head end, the catheter deflectable section, the fixed bent section, the catheter main body and the catheter handle are connected in sequence.

Furthermore, the catheter head end, the fixed bent section, the catheter deflectable section, the catheter main body and the catheter handle are connected in sequence.

Further, the catheter tip material is polyethylene or PEBAX; the material of the deflectable section, the fixed bend section or/and the catheter main body is TPU, nylon or PEBAX with metal braiding.

Further, the catheter head end, the catheter deflectable section, the fixed bent section and the catheter main body are connected in sequence through welding or gluing.

Further, the catheter head end, the fixed bent section, the catheter deflectable section and the catheter main body are sequentially connected in a welding or gluing mode.

Further, the welding mode is hot air reflow welding, high-frequency welding or resistance welding.

Further, the length of the fixed bending section is 50-200mm, the length of the deflectable section is 50-200mm, and the length of the catheter main body is 300-400 mm.

Further, the length of the fixed bending section is 100mm, the length of the deflectable section is 100mm, and the length of the catheter main body is 400 mm.

Furthermore, a hemostatic valve is arranged at the tail end of the catheter handle and communicated with the hollow catheter body.

Further, the far end of the catheter head end is conical, and a discharge hole is formed in the catheter head end.

Further, the fixed bending section and the deflectable section comprise an inner layer and an outer layer, the inner layer is made of polytetrafluoroethylene, PEP or PFA, and the thickness of the inner layer is 0.02-0.5 mm; the outer layer is made of PEBAX, nylon, polyurethane or PE.

Furthermore, a developing ring is sleeved on the outer side of the inner layer of the deflectable section, and the far end of the developing ring is located at the boundary of the fixed bent section and the deflectable section.

Furthermore, a pull wire ring is arranged behind the developing ring, and the two pull wires are respectively fixed on two sides of the pull wire ring.

Further, the pull wire is a cylindrical wire, a conical wire or a flat wire, and the pull wire is made of stainless steel or nickel-titanium alloy.

Furthermore, be provided with the stay wire pipe between skin and the inlayer, the stay wire is placed in the stay wire pipe, the stay wire pipe symmetry paste in the outside of inlayer.

Further, the stay wire pipe is a PTFE pipe or a PI pipe with an internal spring sleeve.

Further, a metal braided layer is arranged at the rear end of the pull wire ring, the metal braided layer is formed by braiding stainless steel wires or nickel-titanium alloy wires, the diameter of the stainless steel wires or the nickel-titanium alloy wires is 0.01-0.1mm, and the density of the metal braided layer is 15-100 PPI.

Compared with the prior art, the invention has the following beneficial effects: according to the guide catheter provided by the invention, the first knob and the second knob are arranged on the catheter handle, the first knob is used for controlling the catheter body to rotate along the central shaft of the catheter main body, the second knob is used for controlling the deflection of the deflectable section of the catheter, and the catheter has the fixed bend and the adjustable bend at the same time, so that various bending shapes can be realized according to clinical requirements.

Drawings

FIG. 1 is a schematic view of a guiding catheter for intra-renal ablation according to an embodiment of the present invention;

FIG. 2 is a schematic view of a guiding catheter according to an embodiment of the present invention;

FIG. 3 is a schematic view of a partial cross-sectional structure of a guiding catheter in accordance with an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view taken along A-A of FIG. 3;

FIG. 5 is a schematic view of various bends formed in the distal end of a guiding catheter in accordance with embodiments of the present invention;

FIG. 6 is a schematic view of a guiding catheter according to another embodiment of the present invention;

FIG. 7 is a schematic view of various bends formed in the distal end of a guiding catheter in accordance with another embodiment of the invention;

fig. 8 is a schematic view of the internal structure of a guiding catheter handle according to an embodiment of the invention.

In the figure:

1 ablation catheter 2 guide catheter 3 renal artery

4 kidney 5 inner layer 6 outer layer

7 developing ring 8 pull ring 9 pull wire

10-wire-pulling-tube 11-head electrode 12 metal braided layer

21 catheter handle 22 catheter body 23 deflectable segment

24 fixed bend 25 catheter tip

211 first knob 212 second knob 213 hemostatic valve

214 internally threaded rod 215 and externally threaded rod 216

217 pinion 218 second rack 251 discharge orifice

Detailed Description

The invention is further described below with reference to the figures and examples.

Example 1

FIG. 1 is a schematic view of a guiding catheter for intra-renal ablation according to an embodiment of the present invention; FIG. 2 is a schematic view of a guiding catheter according to an embodiment of the present invention;

referring to fig. 1, renal artery ablation may be used to treat refractory hypertension, which is mainly to ablate the sympathetic nerves on the renal artery, block the sympathetic nerves, and reduce the blood pressure of the hypertensive. Fig. 1 is a schematic view of a guiding catheter used for intra-renal ablation, which is characterized in that firstly, a femoral artery is punctured, a guide wire is introduced, after a passage to a renal artery 3 is established, a renal artery guiding catheter 2 is introduced, the guide wire is withdrawn, a renal artery ablation catheter 1 is inserted from a hemostatic valve 213 at the proximal end of the renal artery guiding catheter 2, and ablation is carried out in the renal artery 3.

Referring to fig. 2 and 3, the guiding catheter provided in this embodiment comprises a catheter tip 25, a fixed bending section 24, a deflectable section 23, a catheter main body 22, and a catheter handle 21. In this embodiment, the catheter tip 25, the fixed bent segment 24, the deflectable segment 23, and the catheter main body 22 are connected by welding or gluing, preferably by a hot air Reflow (Reflow) technique, which can fuse multiple layers of tubes of different materials into one another, or by high frequency welding or resistance welding.

The catheter tip 25 is made of a polymer material, typically polyethylene or polyether block amide (PEBAX). A drainage opening 251 is provided in the catheter tip 25, said drainage opening 251 being intended to drain liquids or gases when inserting or removing a guide catheter, the drainage opening 251 preferably having a diameter of 1 mm. The length of the fixed bent section 24 is 50-200mm, preferably 100mm, and the material of the fixed bent section 24 can be PEBAX with metal braided wire, or thermoplastic polyurethane elastomer (TPU), nylon or other high polymer materials. The length of the deflectable section 23 is 50-200mm, preferably 100mm, and the material of the deflectable section 23 can be PEBAX braided with metal, or TPU, nylon or other high polymer materials. The length of the catheter main body 22 is 300 mm to 400mm, preferably 400mm, and likewise, the length of the catheter main body 22 may be PEBAX with metal braided wires, or TPU, nylon or other high polymer materials.

The catheter handle 21 is capable of controlling rotation of the catheter tube and deflection of the deflectable segment 23, wherein rotation of the first knob 211 causes rotation of the catheter tube about the central axis and rotation of the second knob 212 causes deflection of the deflectable segment 23. The catheter handle 21 has a hemostatic valve 213 at the end, the hemostatic valve 213 is connected to the hollow catheter tube, and the ablation catheter 1 can enter the catheter handle 21 through the hemostatic valve 213 and then enter the catheter tube.

FIG. 3 is a schematic view of a partial cross-sectional structure of a guiding catheter in accordance with an embodiment of the present invention; fig. 4 is a schematic cross-sectional view taken along a-a in fig. 3.

Referring to fig. 3 and 4, in the present embodiment, fig. 3 is a partial cross-sectional view of the distal end of the guiding catheter 2. The distal end of the catheter tip 25 is tapered at a taper of 1: 30 to 1: 50, such as 1: 30, 1: 40, 1: 50, preferably 1: 40. The fixed bend 24 is mainly composed of two layers: inner layer 5 and outer layer 6, wherein inner layer 5 is a polytetrafluoroethylene layer, and may be other fluoroplastics, such as fluorinated ethylene propylene copolymer (FEP) or soluble Polytetrafluoroethylene (PFA), etc., and the thickness of the inner layer is 0.02-0.5mm, preferably 0.1 mm. The outer layer 6 is made of nylon, polyurethane or Polyethylene (PE). The inner layer 5 and the outer layer 6 may be connected by a hot air reflow (reflow) technique, or may be connected by high frequency welding, gluing, or the like.

The fixed bend 24 and the deflectable segment 23 generally define the distal end of the developer ring 7. The outer side of the inner layer at the far end of the deflectable section 23 is sleeved with a developing ring 7, and the developing ring 7 is respectively connected with the inner layer 5 and the outer layer 6, which is generally platinum iridium alloy, and can also be platinum, gold, tantalum, tungsten-containing polymer or barium oxide-containing polymer material. The developing ring 7 is connected with the inner layer 5 and the outer layer 6 through gluing, a pull ring 8 is arranged behind the developing ring 7, and the material of the pull ring 8 can be stainless steel, nickel-titanium alloy or platinum-iridium alloy. The distance between the developing ring 7 and the pull ring 8 is 0-20 mm. Similarly, the pull wire ring 8 is connected to the inner layer 5 and the outer layer 6, respectively. The pull wires 9 are respectively welded on two sides of the pull wire ring 8, the pull wires 9 can be cylindrical wires, conical wires or flat wires, and the pull wires 9 can be made of stainless steel or nickel-titanium alloy. The pull wire 9 passes into the catheter handle 21 in the direction of the catheter and is anchored in the catheter handle 21.

A stay wire tube 10 is arranged between the outer layer 6 and the inner layer 5 and used for placing a stay wire 9, the stay wire tube 10 is symmetrically adhered to two sides of the inner layer 5, and the stay wire tube 10 can be a Polytetrafluoroethylene (PTFE) tube or a Polyimide (PI) tube with a built-in spring sleeve. The metal braid 12 is fused at the rear end of the stay wire ring 8, the metal wire of the metal braid 12 can be stainless steel or nickel-titanium alloy wire, the wire diameter is 0.01-0.1mm, the density of the metal braid 12 is 15-100PPI (mesh per inch), the outer layer 6 is made of PEBAX, nylon or polyurethane, or Polyethylene (PE).

Fig. 5 is a schematic view of various bends formed in the distal end of a guiding catheter in accordance with an embodiment of the present invention.

The fixed bending section 24 can be made by a thermal fixing mold, and the conduit without fixed bending is placed according to the bending groove preset by the mold and then is placed into a heating device for thermal forming, wherein the forming temperature is different according to different materials, and is generally between 100 degrees and 250 degrees. The bending shape of the preset bending groove can be adjusted according to the requirement, and a series of fixed bending sections with different bending shapes can be manufactured. Fig. 5 is a preset curved diagram of different shapes formed by two fixed curved guide catheters after being deflected by a deflectable section, and the deflection angle of the deflectable section can be controlled by adjusting the proportion of a soft section and a soft section on the deflectable section. Accordingly, it will be appreciated by those skilled in the relevant art that the fixed curve and deflectable curve of the guiding catheter can be achieved by modifying the fixed curve length, the length of the deflectable segment, the fixed curve, the ratio of the deflectable soft segment and the deflectable segment, depending on the clinical requirements.

Example 2

FIG. 6 is a schematic view of a guiding catheter according to another embodiment of the present invention; fig. 7 is a schematic view of various bends formed in the distal end of a guiding catheter in accordance with another embodiment of the invention.

In the previous embodiment, the fixed bend 24 is located between the catheter tip 25 and the deflectable segment 23, and in this embodiment, the fixed bend 24 is located between the deflectable segment 23 and the catheter body 22. The length of the fixed bend 24 is between 50-400mm, preferably 150mm, and the length of the deflectable segment is between 50-200mm, more preferably 50-100 mm. The structure of this embodiment is basically similar to that of fig. 3, and the fixed bending of the fixed bending die is performed after the tube is processed by the Reflow technique. Fig. 7 is a schematic view of the embodiment with the fixed bend segment 24 at the proximal end and the deflectable catheter segment 23 at the distal end, the deflectable catheter segment 23 being deflectable as controlled by the catheter handle 21. Also, as will be appreciated by those skilled in the relevant art of deflectable segment 23, the fixed curve and deflectable curve of the guiding catheter may be achieved by modifying the fixed curve length, deflectable segment length, fixed curve, ratio of deflectable soft segments and deflectable soft segments, depending on the clinical requirements.

Referring to fig. 8, the distal end of the catheter handle 21 is provided with a first knob 211, the first knob 211 is a hollow cylinder, and the inner surface of the hollow portion and the outer surface of the catheter main body 22 are adhered and fixed to each other, so that when the first knob 211 is rotated, the entire catheter body can rotate around the central axis. The second knob 212 controls the deflection of the deflectable section 23 of the catheter, which primarily achieves bi-directional deflection through the transmission principle of rotational to linear motion.

In this embodiment, an internal threaded rod 214, an external threaded rod 215, a gear 216, a first rack 217 and a second rack 218 are disposed in the catheter handle 21, the second knob 212 is engaged with the internal threaded rod 214, the second knob 212 may be directly fixed on the outer surface of the internal threaded rod 214, or the second knob 212 is fixed on the outer surface of the catheter handle 21, the internal threaded rod 214 is fixedly connected to the catheter handle 21, as long as the second knob 212 is rotated to drive the internal threaded rod 214 to rotate; the inner side of the inner threaded rod 214 is provided with inner threads, the outer side of the outer threaded rod 215 is provided with outer threads, the inner threads and the outer threads can be movably connected in a spiral matching mode, the outer threaded rod 215 is fixedly connected with a first rack 217, the first rack 217, a gear 216 and a second rack 218 are sequentially meshed and connected, one ends of two pull wires 9 are respectively fixed on the first rack 217 and the second rack 218 and are fastened by screws or can be adhered. When the second knob 212 is rotated, the inner threaded rod 214 is rotated, the inner thread of the inner threaded rod 214 is engaged with the outer thread of the outer threaded rod 215 to drive the outer threaded rod 215 to move forward or backward, and the outer threaded rod 215 drives the second rack 218 to move forward or backward through the first rack 217 and the gear 216. Here, the direction of movement of the first rack 217 is opposite to that of the second rack 218, even if the two wires 9 are in different states of tightness at the same time, so that the purpose of guiding the catheter to deflect in both left and right directions is achieved.

In summary, according to the guiding catheter provided by the present invention, the first knob 211 and the second knob 212 are disposed on the catheter handle 21, the first knob 211 is used for controlling the catheter body to rotate along the central axis of the catheter body, the second knob 212 is used for controlling the deflection of the deflectable section 23 of the catheter, and the catheter has both fixed bending and adjustable bending, so that various bending shapes can be realized according to clinical requirements.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A guide catheter, comprising:

a catheter shaft comprising a catheter tip, a catheter deflectable segment, a fixed bend segment, and a catheter body, an

The catheter handle is connected with the catheter body;

the fixed curved section is positioned between the catheter head end and the deflectable section;

the catheter comprises a catheter body, a catheter handle, a first knob, a second knob, a pull wire and a control circuit, wherein the catheter body is internally provided with the pull wire, the catheter handle is provided with the first knob and the second knob, the first knob is connected with the catheter body and used for controlling the catheter body to rotate along a central shaft of a catheter main body, and the second knob is connected with the pull wire and used for controlling the deflection of a deflectable section of the catheter;

the first knob is a hollow cylinder, and the inner surface of the cylinder and the outer surface of the catheter body are fixed with each other.

2. The guiding catheter as defined in claim 1, wherein an internal threaded rod, an external threaded rod, a gear, a first rack and a second rack are disposed in the catheter handle, the second knob is fixedly connected to the internal threaded rod, the internal threaded rod has an internal thread, the external threaded rod has an external thread, the internal thread is in threaded connection with the external thread, the external threaded rod is fixedly connected to the first rack, the gear and the second rack are sequentially engaged, and the number of the pull wires is two and is respectively fixed to the first rack and the second rack.

3. The guide catheter of claim 2, wherein the pull wire is secured to the first and second racks by screws or glue.

4. The guide catheter of claim 1, wherein the catheter tip, the fixed curve segment, the catheter deflectable segment, the catheter body, and the catheter handle are connected in series.

5. The guide catheter of claim 1, wherein the catheter tip material is polyethylene or PEBAX; the material of the deflectable section, the fixed bend section or/and the catheter main body is TPU, nylon or PEBAX with metal braiding.

6. The guide catheter of claim 4, wherein the catheter tip, the fixed bend segment, the deflectable segment of the catheter and the catheter body are joined by welding or gluing, in sequence.

7. The guide catheter of claim 6, wherein the welding is hot air reflow welding, high frequency welding, or resistance welding.

8. The guide catheter of claim 1, wherein the fixed curve segment has a length of 50-200mm, the deflectable segment has a length of 50-200mm, and the catheter body has a length of 300-400 mm.

9. The guide catheter of claim 8, wherein the fixed curve segment has a length of 100mm, the deflectable segment has a length of 100mm, and the catheter body has a length of 400 mm.

10. The guide catheter of claim 1, wherein the trailing end of the catheter handle is provided with a hemostasis valve in communication with the hollow catheter tube.

11. The guide catheter of claim 1, wherein the distal end of the catheter tip is tapered, and the catheter tip is provided with a drainage hole.

12. The guide catheter of claim 1, wherein the fixed curve section and the deflectable section comprise an inner layer and an outer layer, the inner layer being made of polytetrafluoroethylene, FEP or PFA, the inner layer having a thickness of 0.02-0.5 mm; the outer layer is made of PEBAX, nylon, polyurethane or PE.

13. The guide catheter of claim 12, wherein the inner layer of the deflectable segment is externally sleeved with a visualization ring, and a distal end of the visualization ring is located at a boundary between the fixed curved segment and the deflectable segment.

14. The guide catheter of claim 13, wherein a pull wire ring is disposed behind the visualization ring, and two pull wires are fixed to both sides of the pull wire ring.

15. The guide catheter of claim 14, wherein the pull wire is a cylindrical wire, a tapered wire, or a flat wire, and the pull wire material is stainless steel or nitinol.

16. The guide catheter of claim 14, wherein a pull wire tube is disposed between the outer layer and the inner layer, the pull wire being disposed within the pull wire tube, the pull wire tube being symmetrically affixed to the outer side of the inner layer.

17. The guide catheter of claim 16, wherein the pull tube is a PTFE tube or an innerspring sleeved PI tube.

18. The guide catheter of claim 14, wherein the rear end of the pull wire ring is provided with a metal braid, the metal braid being braided from stainless steel wires or nitinol wires having a diameter of 0.01-0.1mm, the metal braid having a density of 15-100 PPI.