Disclosure of Invention
The invention aims to: aiming at the problems that whether a catheter head terminal electrode is out of a sheath can not be accurately determined by using a potential detection mode and the problems that a patient and a doctor are greatly radiated and the health is harmed by using an X-ray sheath entering and exiting mode, the prior art provides a catheter sheath entering and exiting detection part and method, an electrophysiological catheter and a guiding sheath.
In order to achieve the purpose, the invention adopts the technical scheme that:
a catheter access sheath detection component comprising:
the interference assembly is arranged at the tail end sheath of the guide sheath and can generate an interference magnetic field;
the first magnetic positioning sensor is arranged on a tail end catheter of the electrophysiology catheter and can output a normal signal in a magnetic field generated by the magnetic field generator;
the second magnetic positioning sensor is arranged on the tail end catheter and can output a normal signal in a magnetic field generated by the magnetic field generator;
wherein, the distance from one end of the interference component far away from the tail end sheath pipe opening to the tail end sheath pipe opening is D1The first magnetic positioning sensor and the second magnetic positioning sensor are arranged along the axial direction of the tail end catheter at intervals with a distance D2The first magnetic positioning sensor is close to the end part of the tail end catheter, the first magnetic positioning sensor is positioned behind the adjustable bending area of the tail end catheter, and D1=D2。
By adopting the catheter in-out sheath detection component, the interference component is used for respectively interfering the first magnetic positioning sensor and the second magnetic positioning sensor, and the distance from one end of the interference component, which is far away from the tail end sheath opening, to the tail end sheath opening is equal to the distance between the first magnetic positioning sensor and the second magnetic positioning sensor, so that when the first magnetic positioning sensor outputs a normal signal and the second magnetic positioning sensor generates an interference signal, the bendable region of the tail end catheter can be judged to extend out of the tail end sheath.
Preferably, the interfering member is a ring structure.
Preferably, the interfering component is a permanent magnet.
Preferably, the first magnetic positioning sensor and the second magnetic positioning sensor are coils wound by electrode wires, and can generate current signals in a magnetic field generated by the magnetic field generator.
The invention also provides a method for detecting the entry and exit of a catheter by applying the detection component as described in any one of the above steps, which comprises the following steps:
A. the tail end catheter is inserted into the guide sheath, and the first magnetic positioning sensor and the second magnetic positioning sensor both output normal signals in a magnetic field generated by the magnetic field generator;
B. continuing to advance the distal catheter, the first magnetic positioning sensor generating an interfering signal and the second magnetic positioning sensor outputting a normal signal indicating that the first magnetic positioning sensor is now at the interfering assembly;
C. continuing to advance the distal catheter until the first magnetic position sensor outputs a normal signal and the second magnetic position sensor generates an interfering signal indicating that the second magnetic position sensor is at the interfering component due to D1=D2And the adjustable bending area of the tail end catheter extends out of the tail end sheath.
By adopting the method for detecting the sheath entering and exiting of the catheter, disclosed by the invention, the position of the electrophysiological catheter can be identified on the guiding sheath by utilizing the principle of magnetic field interference under the condition of not increasing processing equipment, and whether the adjustable bending area of the tail end catheter extends out of the tail end sheath is judged.
The invention also provides an electrophysiology catheter which comprises a tail end catheter, wherein a first magnetic positioning sensor and a second magnetic positioning sensor are arranged at an interval of D along the axial direction of the tail end catheter2Said first magnetic positioning sensor being proximate to an end of said tip catheter, said first magnetic positioning sensorThe device is positioned behind the adjustable bending area of the tail end catheter, and the first magnetic positioning sensor and the second magnetic positioning sensor can output normal signals in a magnetic field generated by the magnetic field generator;
the electrophysiology catheter is used for being matched with a guide sheath, an interference component is arranged on a tail end sheath of the guide sheath, the interference component can generate an interference magnetic field, and the interference component is far away from one end of an opening of the tail end sheath to the distance D from the opening of the tail end sheath1,D1=D2。
By adopting the electrophysiology catheter, whether the adjustable bending area of the tail end catheter extends out of the tail end sheath can be judged according to the principle of magnetic field interference.
Preferably, the distal catheter end is provided with a plurality of electrodes.
Further preferably, the electrodes are located on a side wall of the tip catheter.
Further preferably, the electrodes are evenly distributed.
The invention also provides a guide sheath tube, which comprises a tail end sheath tube, wherein an interference component is arranged on the tail end sheath tube, the interference component can generate an interference magnetic field, and the distance from one end of the interference component far away from the opening of the tail end sheath tube to the opening of the tail end sheath tube is D1;
The guiding sheath is used for matching with an electrophysiology catheter, and the tail end catheter of the electrophysiology catheter is axially provided with a distance D at intervals2The first magnetic positioning sensor and the second magnetic positioning sensor are close to the end part of the tail end catheter, the first magnetic positioning sensor is located behind the adjustable bending area of the tail end catheter, and the first magnetic positioning sensor and the second magnetic positioning sensor can output normal signals in a magnetic field generated by the magnetic field generator respectively, and D is1=D2。
By adopting the guiding sheath catheter, whether the adjustable bending area of the tail end catheter extends out of the tail end sheath catheter or not can be judged according to the principle of magnetic field interference.
Preferably, the guiding sheath tube is designed to be 8.5F, the wall of the inner cavity of the sheath tube is made of PTFE (polytetrafluoroethylene) material, the guiding sheath tube has good self-lubricating performance, a woven layer is arranged outside the wall of the inner cavity of the sheath tube, and an outer tube layer is arranged outside the woven layer.
Further preferably, the woven layer is a stainless steel wire woven layer.
Further preferably, the outer tube layer is a polyurethane material or PEBAX (polyether block polyamide).
Further preferably, the material of the outer tube layer is provided with a developing material.
Further preferably, the developing material comprises 20% of the material of the outer tube layer.
Further preferably, the developing material is barium sulfate.
Preferably, the interference component is arranged on the wall of the inner cavity of the sheath tube.
Further preferably, the interference component is bonded to the wall of the sheath lumen.
Preferably, the end sheath end side wall is provided with a vent hole provided on the end sheath for the purpose of facilitating a suction operation and reducing a void bubble.
Further preferably, the vent hole is 3mm-5mm away from the end sheath opening.
Preferably, the tail end sheath tube is connected with an adjustable bending section, and the adjustable bending section is connected with the control handle.
Further preferably, the adjustable bending section is connected with a straight pipe section, and the straight pipe section is connected with the control handle.
Further preferably, the adjustable bending section and the straight pipe section are both provided with a woven steel wire layer, and the woven steel wire layer is used for enhancing the rigidity and the torque performance of the pipe body.
Further preferably, the layer of braided steel wires is a double-strand braided member.
Further preferably, the adjustable bending section comprises a traction ring and a support hose connected with the traction ring, the traction ring is connected with the tail end sheath, the support hose is connected with the control handle, a traction rope is arranged in the support hose, one end of the traction rope is connected with the traction ring, and the other end of the traction rope is connected with the control handle.
Further preferably, two of the pull cords are attached to opposite sides of the pull ring.
Further preferably, the hauling cable is a stainless steel cable.
Further preferably, the traction ring is a stainless steel ring.
Further preferably, the support hose is a PTFE tube or a polyimide tube, which has a low friction coefficient and can be used for smooth sliding of the pulling rope therein.
Further preferably, the traction ring is connected to the interference assembly.
Preferably, a knob is arranged on the control handle and used for retracting the traction rope to perform bending adjustment control on the adjustable bending section.
Further preferably, the knob is used for controlling the adjustable bending section to bend when rotating clockwise, and is used for controlling the adjustable bending section to straighten when rotating anticlockwise.
Further preferably, the tail part of the control handle is provided with a three-way pipe, and the three-way pipe is used for injecting medicines and physiological saline.
Further preferably, the three-way pipe is connected with a hemostatic valve for the passage of an electrophysiology catheter, a puncture needle or a dilatation tube.
In summary, due to the adoption of the technical scheme, the invention has the beneficial effects that:
1. according to the catheter in-out sheath detection component, the interference component is used for respectively interfering the first magnetic positioning sensor and the second magnetic positioning sensor, and the distance from one end, far away from the tail end sheath opening, of the interference component to the tail end sheath opening is equal to the distance between the first magnetic positioning sensor and the second magnetic positioning sensor, so that when the first magnetic positioning sensor outputs a normal signal and the second magnetic positioning sensor generates an interference signal, the fact that the bendable region of the tail end catheter extends out of the tail end sheath can be judged, and the catheter in-out sheath detection component is simple in structure, convenient to use and good in effect;
2. according to the method for detecting the sheath passing in and out of the catheter, disclosed by the invention, the position of the electrophysiological catheter can be identified on the guiding sheath by utilizing the principle of magnetic field interference under the condition that no processing equipment is added, and whether the adjustable bending area of the tail end catheter extends out of the tail end sheath is judged;
3. the electrophysiology catheter can judge whether the adjustable bending area of the tail end catheter extends out of the tail end sheath catheter or not according to the principle of magnetic field interference, and has the advantages of simple structure, convenience in manufacturing and good effect;
4. the guiding sheath pipe can judge whether the adjustable bending area of the tail end catheter extends out of the tail end sheath pipe or not according to the principle of magnetic field interference.
Detailed Description
The present invention will be described in detail below with reference to the accompanying drawings.
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Example 1
As shown in fig. 1-8, a guiding sheath and an electrophysiology catheter used in conjunction therewith according to the present invention.
The guide sheath and the electrophysiology catheter are respectively provided with a catheter in-out sheath detection component which is used in a matched mode, and the catheter in-out sheath detection component comprises an interference component 6, a first magnetic positioning sensor 02 and a second magnetic positioning sensor 03.
The design of guide sheath pipe is 8.5F, and its sheath pipe inner chamber 11's wall is made for having good self-lubricating performance's PTFE material, be equipped with the weaving layer outside the 11 walls of sheath pipe inner chamber, the weaving layer is the stainless steel wire weaving layer, be equipped with outer tube layer outward, outer tube layer is polyurethane material or PEBAX, be equipped with development material in the material of outer tube layer, development material accounts for 20% of the material on outer tube layer, specifically, development material is barium sulfate.
The guiding sheath pipe comprises a tail end sheath pipe 1, an adjustable bending section 2, a straight pipe section 3 and an operation handle 4 which are connected in sequence.
Set up on terminal sheath 1 interference subassembly 6, interference subassembly 6 can produce the interference magnetic field, interference subassembly 6 is far away from 1 open-ended one end of terminal sheath is arrived 1 open-ended distance of terminal sheath is D1(ii) a Interference component 6 bond in on the wall of sheath pipe inner chamber 11, be equipped with exhaust hole 5 on the 1 tip lateral wall of terminal sheath pipe, exhaust hole 5 sets up the last purpose of terminal sheath pipe 1 is the suction operation of being convenient for and reduces the cavity bubble, exhaust hole5 is 3mm-5mm away from the opening of the tail end sheath tube 1.
Specifically, the interference component 6 is an annular permanent magnet structure, and includes elements such as iron, cobalt, and nickel.
The adjustable bending section 2 comprises a traction ring 7 and a support hose 9 connected with the traction ring 7, the traction ring 7 is a stainless steel ring, the traction ring 7 is connected with the interference component 6 of the tail end sheath tube 1, the support hose 9 is connected with the control handle 4, two traction ropes 8 are arranged in the support hose 9, the two traction ropes 8 are connected to two opposite sides of the traction ring 7, the traction ropes 8 are stainless steel wire ropes, one end of each traction rope 8 is connected with the traction ring 7, the other end of each traction rope is connected with the control handle 4, the support hose 9 is a PTFE (polytetrafluoroethylene) tube or a polyimide tube, and the friction coefficient of the tube is low, so that the adjustable bending section can be used for smooth sliding of the traction ropes 8 in the tube; the adjustable bending section 2 and the straight pipe section 3 are both provided with a woven steel wire layer, the woven steel wire layer is used for enhancing the rigidity and the torque performance of the pipe body, and the woven steel wire layer is a double-strand woven component.
A knob 43 is arranged on the control handle 4, the knob 43 is used for retracting and releasing the traction rope 8 to perform bending control on the adjustable bending section 2, the knob 43 is used for controlling the adjustable bending section 2 to bend when rotating clockwise, and the knob 43 is used for controlling the adjustable bending section 2 to straighten when rotating anticlockwise; the tail of the control handle 4 is provided with a three-way pipe 41, the three-way pipe 41 is used for injecting medicines and physiological saline, the three-way pipe 41 is connected with a hemostatic valve 42, and the hemostatic valve 42 is used for allowing an electrophysiological catheter, a puncture needle or an expansion tube to pass through.
The electrophysiology catheter comprises a tail end catheter 01, wherein the tail end catheter 01 is axially arranged at intervals with a distance D2The first magnetic positioning sensor 02 and the second magnetic positioning sensor 03, the first magnetic positioning sensor 02 is close to the end part of the tail end catheter 01, the first magnetic positioning sensor 02 is located behind the bending adjustable region of the tail end catheter 01, the first magnetic positioning sensor 02 and the second magnetic positioning sensor 03 can both output normal signals in a magnetic field 04 generated by a magnetic field generator, and D is1=D2。
Specifically, the first magnetic positioning sensor 02 and the second magnetic positioning sensor 03 are coils wound by electrode wires, and can generate current signals in a magnetic field 04 generated by the magnetic field generator.
The end part of the tail end guide pipe 01 is provided with a plurality of electrodes which are uniformly distributed on the side wall of the tail end guide pipe 01.
By applying the guiding sheath and the electrophysiology catheter, whether the adjustable bending area of the tail end catheter 01 extends out of the tail end sheath 1 can be judged according to the principle of magnetic field interference, specifically, the interference component 6 is used for respectively interfering the first magnetic positioning sensor 02 and the second magnetic positioning sensor 03, since the distance from the end of the interference element 6 remote from the opening of the distal sheath 1 to the opening of the distal sheath 1 is equal to the distance between the first magnetic positioning sensor 02 and the second magnetic positioning sensor 03, therefore, when the first magnetic positioning sensor 02 outputs a normal signal, and the second magnetic positioning sensor 03 generates an interference signal, the bending adjustable area of the tail end catheter 01 can be judged to extend out of the tail end sheath 1, and the guiding sheath and the electrophysiology catheter are simple in structure, convenient to manufacture and good in effect.
Example 2
As shown in fig. 1-8, a method for detecting sheath entry and exit of a catheter according to the present invention is applied to a guiding sheath and an electrophysiology catheter used with the guiding sheath as described in embodiment 1, and the method comprises the following steps:
A. the distal catheter 01 is inserted into the guiding sheath, and the first magnetic positioning sensor 02 and the second magnetic positioning sensor 03 both output normal signals in the magnetic field 04 generated by the magnetic field generator, and no electrophysiological signal is detected by the electrode on the distal catheter 01;
B. continuing to advance the distal catheter 01, the first magnetic positioning sensor 02 generates an interference signal and the second magnetic positioning sensor 03 outputs a normal signal indicating that the first magnetic positioning sensor 02 is now at the interfering assembly 6;
C. continue to propel forwardThe distal catheter 01 until the first magnetic positioning sensor 02 outputs a normal signal, the second magnetic positioning sensor 03 generates an interference signal, and the electrode on the distal catheter 01 detects the electrophysiological signal, indicating that the second magnetic positioning sensor 03 is located at the interfering component 6, due to D1=D2The bending adjustable area of the tail end catheter 01 extends out of the tail end sheath 1.
By using the principle of magnetic field interference, the method for detecting the sheath passing in and out of the catheter can identify the position of the electrophysiological catheter on the guiding sheath without adding processing equipment, and judge whether the bendable region of the tail end catheter 01 extends out of the tail end sheath 1.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.