CN113616326A - Pulse ablation device with saline water perfusion function - Google Patents

Abstract

The invention discloses a pulse ablation device with a saline water perfusion function, which comprises a catheter component, wherein the catheter component is provided with a working end and also comprises: and the discharge electrodes are arranged on the working end and distributed along the axis array of the catheter component, perfusion holes are formed in the discharge electrodes, the polarities of the adjacent discharge electrodes are different, and the perfusion holes of the discharge electrodes supply water independently or supply water in a centralized manner. In the pulse discharge device provided by the invention, a perfusion hole capable of perfusing physiological saline is directly arranged on a discharge electrode generating an electric field; in the ablation operation, the normal saline is poured from the discharge electrode, so that the normal saline is directionally poured to the cell tissues of a patient, and the directional ablation is carried out by matching with an electric field; the device can improve the distribution density of the pulse electric field at the target tissue side, improve the ablation effect and improve the stability of the ablation operation.

Description

Pulse ablation device with saline water perfusion function

Technical Field

The invention relates to the technical field of medical equipment, in particular to a pulse ablation device with a saline water perfusion function.

Background

The effect of pulsed electric fields on tissue ablation is important in relation to the gradient of the electric field in tissue contact.

In the ablation operation treatment, when the catheter electrode is well attached to the tissue or positioned in the blood pool, the distribution of the pulse electric field is relatively uniform, the duration is reliable, and the ablation effect is good. However, in the process of ablation operation treatment of cavities such as esophagus, the stable adhesion of the discharge end and cell tissue cannot be ensured, and the esophagus is not filled with conductive liquid like blood vessels, so that the ablation effect of the part is not easy to ensure, and an ideal state cannot be achieved. It can be seen that the application of pulsed electric field ablation techniques to tissue lacking perfusion of body fluids has certain limitations.

In the prior art, a radio frequency ablation discharging device with a saline perfusion function has been provided, and a perfusion tube is added on a catheter to perfuse physiological saline to cell tissues during an ablation operation, so as to cool the surface of an electrode and improve the current conductivity, thereby improving the ablation effect.

However, in the field of pulsed electric field ablation, there is no catheter design associated with saline infusion.

Disclosure of Invention

According to one aspect of the present invention, there is provided an impulse ablation device with saline infusion functionality, comprising a catheter assembly having a working end, and further comprising,

the discharge electrodes are arranged on the working end and distributed along the axis array of the catheter component, perfusion holes are formed in the discharge electrodes, the polarities of the adjacent discharge electrodes are different, and the perfusion holes of the discharge electrodes supply water independently or supply water in a centralized mode.

The invention provides a pulse discharge device specially used for ablating cell tissues, which can solve the problems in the background art and effectively improve the ablation effect. In the device, a discharge electrode generating an electric field is directly provided with a perfusion hole capable of perfusing physiological saline; in the ablation operation, the normal saline is poured from the discharge electrode, so that the normal saline is directionally poured to the cell tissues of a patient, and the directional ablation is carried out by matching with an electric field; the device can improve the effect of the ablation operation and improve the stability of the ablation operation.

In some embodiments, the impulse ablation device with saline infusion function further comprises two aqueducts disposed in the catheter assembly, and the discharge electrodes of the same polarity are commonly communicated with one of the aqueducts.

Thus, water is supplied through the same water conduit with the same polarity, and short circuit of the electrodes can be prevented.

In some embodiments, the pulse ablation device with saline perfusion function further comprises the same number of aqueducts as the discharge electrodes, the aqueducts are arranged in the catheter component, and the perfusion hole of each discharge electrode is independently communicated with the aqueducts.

Therefore, the filling hole of each discharge electrode independently supplies water through the water guide pipe, and the short circuit of the electrodes can be prevented.

In some embodiments, the pulse ablation device with saline perfusion function further comprises a plurality of conducting wires which are the same as the number of the discharge electrodes, a plurality of the conducting wires are arranged in the catheter component, and a plurality of the discharge electrodes are respectively connected with a plurality of the conducting wires.

Thus, a conductive wire is also provided at the cavity within the catheter assembly, through which the electrode is electrically conductive.

In some embodiments, the catheter assembly includes a first catheter configured as a working end, a bight portion, a second catheter connected to the first catheter by the bight portion, and a pull wire disposed within the second catheter and connected at one end to the bight portion.

Therefore, the catheter assembly is composed of the parts, and the bending part can be controlled through the pull wire, so that the first catheter arranged at one end of the bending part is controlled to be bent.

In some embodiments, the water conduit comprises a joint and a hose, wherein one end of the joint is arranged in the first conduit and penetrates through the conduit wall to be connected with the perfusion hole;

the hose is arranged at the other end of the connector and penetrates through the first conduit, the bending part and the second conduit to be communicated with an external perfusion source.

Therefore, the connector penetrates through the pipe wall of the first conduit to be welded with the perfusion hole, and the hose penetrates through the first conduit, the bent part and the pipe cavity of the second conduit to be communicated with an external perfusion source.

In some embodiments, the bending part comprises a third conduit and a stress head, wherein one end of the third conduit is connected with the first conduit through the stress head, and the other end of the third conduit is connected with the second conduit; the pull wire penetrates through the third conduit and is connected with the stress head.

The pull wire pulls the force-bearing head to bend the third conduit, thereby changing the direction of the first conduit connected to the force-bearing head.

In some embodiments, the impulse ablation device with saline infusion further comprises a marker electrode disposed at the working end of the catheter assembly and located to one side of the plurality of discharge electrodes.

Thus, when the patient is used in the field of arrhythmia, the doctor needs to assist the operation with X-rays. Therefore, it is very important to enable the doctor to deduce the exposed direction of the discharge electrode under the X-ray. The catheter assembly on the same side of the discharge electrode is provided with a marker electrode, and a doctor can judge the orientation of the discharge side by the marker electrode.

In some embodiments, the discharge electrodes and the marking electrodes are all sleeved at the working end of the catheter assembly, the working end of the catheter assembly is provided with a heat shrinkage film, the heat shrinkage film wraps the discharge electrodes and the marking electrodes, and gaps are formed in the heat shrinkage film corresponding to the discharge electrodes and the marking electrodes.

Therefore, the discharge electrode is wrapped by the heat-shrinkable film, and the notch is correspondingly cut off from the heat-shrinkable film, so that the perfusion hole of the discharge electrode is exposed.

In some embodiments, the heat shrink film is provided with a number of filler layers outside the heat shrink film, the filler layers configured to fill and smooth the recesses of the working end of the catheter assembly.

Therefore, the filling layers are respectively positioned on one side of the discharge electrode at the head end and used for plugging the opening of the heat shrinkage film, among the discharge electrodes, between the discharge electrode at the tail end and the marking electrode and on one side of the marking electrode and sewing the gap of the heat shrinkage film.

The invention has the following beneficial effects: the discharge electrode in the device is provided with the perfusion hole, so that the physiological saline can be perfused to the cell tissues of the patient in a directional manner in the ablation operation, the electric field is matched for ablation, the distribution density of the pulse electric field at the target tissue side can be effectively improved, the ablation effect is improved, and the stability of the ablation operation is improved.

Drawings

Fig. 1 is a perspective view of a pulse ablation device with saline infusion in accordance with an embodiment of the present invention.

Fig. 2 is a perspective view of the impulse ablation device of fig. 1 with saline infusion functionality in another configuration.

Fig. 3 is a schematic sectional perspective view of a portion of fig. 1 with saline infusion.

Fig. 4 is an enlarged schematic view of a portion a shown in fig. 3.

Reference numbers in the figures: 1. a catheter assembly; 1a, a working end; 11. a first conduit; 12. bending the part; 13. a second conduit; 14. a pull wire; 2. a discharge electrode; 21. a perfusion hole; 3. a water conduit; 31. a joint; 32. a hose; 4. a conductive wire; 121. a third conduit; 122. a stress head; 5. marking the electrode; 6. a heat-shrinkable film; 7. and (5) filling the layer.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings.

Example one

Fig. 1 schematically shows an impulse ablation device with saline infusion function according to an embodiment of the present invention, including a catheter assembly 1, the catheter assembly 1 having a working end 1a, and further including

Thedischarge electrodes 2 are arranged on the working end 1a, thedischarge electrodes 2 are distributed along the axis array of the duct assembly 1, thedischarge electrodes 2 are provided withfilling holes 21, the polarities of theadjacent discharge electrodes 2 are different, and thefilling holes 21 are arranged in the middle of thedischarge electrodes 2.

In the device, adischarge electrode 2 generating an electric field is directly provided with aperfusion hole 21 capable of perfusing physiological saline; in the ablation operation, the normal saline is poured from thedischarge electrode 2, so that the normal saline is directionally poured to the cell tissues of the patient, and the directional ablation is carried out by matching with an electric field; the device can improve the effect of the ablation operation and improve the stability of the ablation operation.

In this embodiment, to better explain the components in this embodiment, the extending direction of the catheter assembly 1 is designated as the L-axis, and the distal end is the end that enters the human body first in the device, whereas the proximal end is the opposite end. With reference to fig. 1-2, the forward direction of the L-axis is the forward-side direction, and vice versa the rearward-side direction. The present device is further described in detail below with reference to the concept of the L-axis.

In this embodiment, threedischarge electrodes 2 are provided, and the threedischarge electrodes 2 are linearly arrayed at the working end 1a of the duct assembly 1 along the L axis. Two of thedischarge electrodes 2 have the same polarity, and theother discharge electrode 2 has a different polarity from the other twodischarge electrodes 2.

With reference to fig. 3-4, the irrigation holes 21 of thedischarge electrodes 2 with the same polarity supply water in a centralized manner, the pulse ablation device with the saline irrigation function further includes twoaqueducts 3, theaqueducts 3 are arranged in the catheter assembly 1, and thedischarge electrodes 2 with the same polarity are communicated with oneaqueduct 3 together. The same polarity is supplied through thesame water conduit 3, and short circuit of the electrodes can be prevented.

With reference to fig. 3-4, the pulse ablation device with saline perfusion function further includes a plurality of conductive wires 4, the number of which is the same as that of thedischarge electrodes 2, the conductive wires 4 are all disposed in the catheter assembly 1, and thedischarge electrodes 2 are respectively connected to the conductive wires 4. A conductive wire 4 is also provided at the cavity within the catheter assembly 1, the electrode being electrically conductive via the conductive wire 4.

With reference to fig. 2 to 3, the catheter assembly 1 includes afirst catheter 11, a bent portion 12, asecond catheter 13, and a pull wire 14, thefirst catheter 11 is configured as a working end 1a of the catheter assembly 1, a proximal end of thefirst catheter 11 is connected to a distal end of thesecond catheter 13 through the bent portion 12, thefirst catheter 11, the bent portion 12, and thesecond catheter 13 are all provided with lumens, and the pull wire 14 is disposed in thesecond catheter 13 and a distal end thereof is connected to a distal end of the bent portion 12. The catheter assembly 1 is composed of the above-described components, and the bending portion 12 can be controlled by the pull wire 14, thereby performing bending control of thefirst catheter 11 disposed at one end of the bending portion 12.

In this embodiment, two pulling wires 14 are preferably provided, and the two pulling wires 14 are symmetrically arranged, which means that the device can be bent in two directions. However, in other embodiments, one pull wire 14 may be provided, which means that the movable portion of the present apparatus can be bent only in one direction.

With reference to fig. 3-4, thewater guiding pipe 3 includes a joint 31 and aflexible pipe 32, wherein one end of the joint 31 is disposed in thefirst guiding pipe 11 and penetrates through the pipe wall to be connected with the pouringhole 21;

thehose 32 is disposed at the other end of the joint 31, and thehose 32 penetrates thefirst conduit 11, the bent portion 12 and thesecond conduit 13 to communicate with an external perfusion source. Theconnector 31 penetrates through the wall of thefirst conduit 11 and is welded with theperfusion hole 21, and thehose 32 penetrates through the lumens of thefirst conduit 11, the bent part 12 and thesecond conduit 13 and is communicated with an external perfusion source.

With reference to fig. 2-3, the bending part 12 comprises a third conduit 121 and a force-bearing head 122, wherein the distal end of the third conduit 121 is connected with thefirst conduit 11 through the force-bearing head 122, and the proximal end of the third conduit 121 is connected with thesecond conduit 13; the distal end of the pull wire 14 penetrates through the third catheter 121 and is connected with the stress head 122. The third conduit 121 is bent by pulling the force-bearing head 122 by the pulling wire 14, so that thefirst conduit 11 connected to the force-bearing head 122 changes the extending direction. The force-bearing head 122 is preferably made of PEEK, and can better bear the tension of the pull wire 14.

Thewater conduit 3 and the conductive wire 4 penetrate through the lumens of thefirst catheter 11, the third catheter 121 and thesecond catheter 13, and thewater conduit 3 and the conductive wire 4 penetrate out of the proximal end of thesecond catheter 13 to be conducted with an external perfusion source and a power supply. Theaqueduct 3 and the conducting wire 4 are distributed in a staggered way up and down in the space of the tube cavity, and no overlapping part exists.

With reference to fig. 1-2, the pulse ablation device with saline infusion function further includes a marker electrode 5, the marker electrode 5 is disposed at the working end 1a of the catheter assembly 1, and the marker electrode 5 is disposed on a side of the plurality ofdischarge electrodes 2 near the proximal end.

When the X-ray diagnosis instrument is used in the arrhythmia field, a doctor needs to assist operation by means of X-rays. Therefore, it is very important to allow the doctor to deduce the exposed direction of thedischarge electrode 2 under X-ray. The catheter assembly 1 on the same side as the discharge side of thedischarge electrode 2 is provided with a marker electrode 5, and the doctor can determine the orientation of the discharge side from the marker electrode 5.

Referring to fig. 4, thedischarge electrodes 2 and the mark electrodes 5 are all sleeved at the working end 1a of the catheter assembly 1, the working end 1a of the catheter assembly 1 is provided with a heat shrinkage film 6, the heat shrinkage film 6 wraps thedischarge electrodes 2 and the mark electrodes 5, and gaps are formed in the heat shrinkage film 6 corresponding to thedischarge electrodes 2 and the mark electrodes 5. Thedischarge electrode 2 is wrapped by the heat-shrinkable film 6, and a notch is correspondingly cut off from the heat-shrinkable film 6, so that theperfusion hole 21 of thedischarge electrode 2 is exposed.

With reference to fig. 4, the heat shrink film 6 is provided with a number of filling layers 7 outside, which filling layers 7 are configured to fill the recesses of the working end 1a of the duct assembly 1 and to smooth the working end 1a of the duct assembly 1.

The filling layers 7 are respectively positioned on one side of thedischarge electrodes 2 at the head end and used for plugging the opening of the heat shrinkage film 6, among thedischarge electrodes 2, between thedischarge electrodes 2 at the tail end and the marking electrode 5 and on one side of the marking electrode 5 and sewing the gap of the heat shrinkage film 6.

The working end 1a of the present apparatus is manufactured by the following steps, i.e., the assembling process steps between thefirst guide duct 11 of the duct assembly 1 and thedischarge electrode 2, thewater guide duct 3, and the lead wire will be described in detail.

S1, pre-drilling a welding hole of the conducting wire 4 in thefirst guide pipe 11, sleeving a plurality of welding holes which are reserved by matching thedischarge electrodes 2 and the marking electrodes 5 on thefirst guide pipe 11, and gluing and fixing;

s2, drilling thedischarge electrode 2 to form a fillinghole 21;

s3, welding the L-shapedconnector 31 to the inner wall of thefirst conduit 11 and communicating with theperfusion hole 21, and inserting thehose 32 into the inner cavity of thefirst conduit 11 to connect with theconnector 31;

s4, leading a lead wire to penetrate into the inner cavity of thefirst catheter 11 and penetrate through the inner wall of thefirst catheter 11 to be welded with the electrode;

s5, welding the PET thermoplastic pipe sleeve outside thefirst guide pipe 11 of thedischarge electrode 2, and performing thermal shrinkage fixation;

s6, cutting the thermoplastic tube to form a gap, exposing thedischarge electrode 2 and the mark electrode 5; in this embodiment, the exposed electrode surface is one half; in other embodiments, the cutting may be performed according to customized requirements, such as one-third of the exposed electrode surface;

and S7, filling the gap between the electrodes with ultraviolet glue, and curing with an ultraviolet lamp to form a filling layer 7. The filling layer 7 blocks the distal opening of the thermoplastic tube, the filling layer 7 fixes the recess of the electrode element, and the filling layer 7 fixes the proximal slit of the thermoplastic tube.

In the practical application of the device, an operating handle is also provided, the proximal part of the device, namely the proximal part of thesecond catheter 13, is connected to the handle, the pull wire 14 is connected with an operation part in the handle, the conducting wire 4 is connected with an internal electric connection end of the handle, theaqueduct 3 is connected with a water supply end in the handle, and the filling and bending functions of the device are controlled through the handle.

The device can be used for ablating tumors in cavities, such as nasopharynx, esophagus, stomach, lung bronchus, duodenum, colon, cervix and the like, and can improve the distribution of a pulse electric field towards a target point by increasing saline perfusion between an electrode and an ablation target point even if a conductive medium is lacked, so that the ablation effect and stability are improved.

The device can also be used for ablation of the epicardial surface of the heart, the epicardial surface is not perfused with blood, only a small amount of lubricating liquid is available, the effect and the stability of the epicardial ablation can be improved by adopting saline perfusion, and the principle is not repeated.

Example two

The present embodiment is substantially the same as the first embodiment, and differs in the water supply manner of the fillinghole 21 of thedischarge electrode 2, specifically, as follows:

the pouringhole 21 of each of thedischarge electrodes 2 is independently supplied with water. The pulse ablation device with the saline water perfusion function further comprisesaqueducts 3 with the same number as thedischarge electrodes 2, theaqueducts 3 are arranged in the catheter component 1, and theperfusion hole 21 of eachdischarge electrode 2 is independently communicated with theaqueducts 3. The fillinghole 21 of eachdischarge electrode 2 independently supplies water through thewater conduit 3, thereby preventing short circuit of the electrodes.

Thedischarge electrode 2 in the device is provided with theperfusion hole 21, so that the physiological saline can be perfused to the cell tissues of patients in a directional manner in the ablation operation, the ablation is carried out by matching with an electric field, the distribution density of the pulse electric field at the target tissue side can be effectively improved, the ablation effect is improved, and the stability of the ablation operation is improved.

What has been described above are merely some embodiments of the present invention. It will be apparent to those skilled in the art that various changes and modifications can be made without departing from the inventive concept thereof, and these changes and modifications can be made without departing from the spirit and scope of the invention.

Claims (10)

1. The pulse ablation device with the saline water perfusion function comprises a catheter component (1), wherein the catheter component (1) is provided with a working end (1a), and is characterized by further comprising

A plurality of discharge electrodes (2) arranged on the working end (1a), a plurality of discharge electrodes (2) are distributed along the axis array of the catheter component (1), a plurality of discharge electrodes (2) are provided with perfusion holes (21), the polarity of two adjacent discharge electrodes (2) is different,

the perfusion holes (21) of each discharge electrode (2) are independently supplied with water, or the perfusion holes (21) of the discharge electrodes (2) with the same polarity are intensively supplied with water.

2. The pulse ablation device with saline infusion function according to claim 1, further comprising two aqueducts (3), wherein the aqueducts (3) are arranged in the catheter assembly (1), and the discharge electrodes (2) with the same polarity are commonly communicated with one aqueduct (3).

3. The pulse ablation device with saline water infusion function according to claim 1, further comprising aqueducts (3) with the same number as the discharge electrodes (2), wherein the aqueducts (3) are arranged in the catheter assembly (1), and the infusion hole (21) of each discharge electrode (2) is independently communicated with the aqueducts (3).

4. The pulse ablation device with saline water perfusion function according to claim 1, further comprising a plurality of conductive wires (4) with the same number as the number of the discharge electrodes (2), wherein the plurality of conductive wires (4) are all arranged in the catheter assembly (1), and the plurality of discharge electrodes (2) are respectively connected with the plurality of conductive wires (4).

5. The ablation device with saline infusion according to any of claims 2 to 4, wherein the catheter assembly (1) comprises a first catheter (11), a bent portion (12), a second catheter (13), and a pull wire (14), wherein the first catheter (11) is configured as a working end (1a), the first catheter (11) is connected with the second catheter (13) through the bent portion (12), and the pull wire (14) is arranged in the second catheter (13) and has one end connected with the bent portion (12).

6. The pulse ablation device with saline water perfusion function according to claim 5, characterized in that the aqueduct (3) comprises a connector (31) and a hose (32), one end of the connector (31) is arranged in the first conduit (11) and penetrates through the wall of the conduit to be connected with the perfusion hole (21);

the hose (32) is arranged at the other end of the joint (31), and the hose (32) penetrates through the first conduit (11), the bent part (12) and the second conduit (13) to be communicated with an external perfusion source.

7. The impulse ablation device with saline infusion function according to claim 5, characterized in that said bending part (12) comprises a third catheter (121), a force head (122), one end of said third catheter (121) is connected with the first catheter (11) through the force head (122), and the other end of said third catheter (121) is connected with the second catheter (13); the pull wire (14) penetrates through the third conduit (121) and is connected with the stress head (122).

8. The pulse ablation device with saline infusion function according to any one of claims 2 to 4, further comprising a marker electrode (5), wherein the marker electrode (5) is arranged at the working end (1a) of the catheter assembly (1), and the marker electrode (5) is arranged at one side of the plurality of discharge electrodes (2).

9. The pulse ablation device with the saline infusion function according to claim 5, wherein a heat-shrinkable film (6) is arranged at the working end (1a) of the catheter assembly (1), the heat-shrinkable film (6) wraps the plurality of discharge electrodes (2) and the marking electrodes (5), and notches are formed in the heat-shrinkable film (6) corresponding to the plurality of discharge electrodes (2) and the marking electrodes (5).

10. The impulse ablation device with saline infusion functionality according to claim 9, characterized in that said heat shrink film (6) is externally provided with a number of filling layers (7), said filling layers (7) being configured to fill recesses of the working end (1a) of the catheter assembly (1) and to smooth the working end (1a) of the catheter assembly (1).

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