CN116549091A

CN116549091A - Pulsed electric field ablation needle

Info

Publication number: CN116549091A
Application number: CN202210102514.2A
Authority: CN
Inventors: 陈传金
Original assignee: Chengdu Siruiding Life Technology Co ltd
Current assignee: Chengdu Siruiding Life Technology Co ltd
Priority date: 2022-01-27
Filing date: 2022-01-27
Publication date: 2023-08-08

Abstract

The invention discloses a pulsed electric field ablation needle. The pulsed electric field ablation needle according to the present invention comprises: a needle cannula for percutaneous penetration into muscle tissue; the needle tube insulating sleeve is wrapped outside the needle tube; and the electrode is arranged outside the needle tube insulating sleeve and is used for conducting pulsed electric field ablation on muscle tissues. The pulsed electric field ablation needle of the present invention is minimally invasively inserted through the skin into muscle tissue to precisely apply pulsed energy to the desired tissue site. Muscle cells can be selectively treated by pulsed electric field techniques without affecting other non-target cell tissues. Meanwhile, as the energy release time is extremely short, the pulse technology can not generate a thermal effect, so that the problems of muscle tissue crusting, tissue blasting and the like are avoided.

Description

Pulsed electric field ablation needle

Technical Field

The invention relates to the field of pulsed electric field ablation, in particular to a pulsed electric field ablation needle.

Background

Currently, the approach that orthopedic surgeons often take is to try to reduce the volume of muscle hypertrophy at the corresponding site.

Currently there are three main approaches to reducing muscle hypertrophy, namely, nerve blocking, muscle partial excision, and botulinum toxin injection. Among them, nerve blocking operation and muscle partial excision operation have durable curative effect but larger wounds and easy damage to nerves, and have more mutated nerves and the risk of miscut; the botulinum toxin injection mode refers to: when the face is thinned, the muscle relaxant paralysis and atrophy are caused by using the botulinum toxin to inject the masseter muscle, so that the purposes of lifting and reducing the masseter muscle are achieved, and the face thinning effect is realized. The principle of shoulder and leg slimming is the same, and when an operation is performed, the botulinum toxin injected into the muscle is used for blocking the release of nerve transmission acetylcholine, so that partial muscle nutrition is reduced, atrophy is generated, and the aim of shoulder/leg slimming is fulfilled. Although the botulinum toxin injection is small in wound, the effect time is short, generally from 6 months to 1 year, and the effect is not durable.

In recent years, with the development of rf ablation technology, rf ablation has been widely used in clinical therapies such as cardiac rf ablation, liver/tumor rf ablation, and the like. The basic principle is that high-frequency alternating current electromagnetic waves are utilized to be led into tissues through a treatment electrode/catheter/needle to generate biological heat, so that proteins in normal cells are denatured and the tissues are coagulated and necrotized, and the aim of clinical treatment is achieved. Young Jin Park first reports that reducing the volume of the bite and gastrocnemius muscles by radiofrequency ablation to thin the face and legs, gives better aesthetics. The radio frequency ablation has long acting time in clinical treatment. However, as radio frequency is non-selective tissue ablation, the damage risk of nerves and blood vessels exists at the same time when the muscle tissue is damaged; meanwhile, when the radio frequency ablation is performed, a large amount of heat is generated, so that the temperature of the tissue rises faster, and the complications such as scalding of skin tissue, hematoma of skin, scars, pigmentation and the like are caused.

Therefore, a treatment with little trauma, durable efficacy, safety and few complications is needed to solve the problem of muscle hypertrophy.

Disclosure of Invention

The invention provides a pulsed electric field ablation needle which is inserted into muscle tissue through skin in a minimally invasive manner and accurately applies pulsed energy to a desired tissue site. Pulsed electric field ablation refers to the application of high voltage electric pulses to phospholipid bilayer of cell membranes in a short time, resulting in formation of transmembrane potential, thereby generating unstable potential, which is irreversible penetrating damage (irreversible electroporation) of cell membranes, causing the cell membranes to generate pores, thereby changing mass exchange at the cell membranes, damaging homeostasis of intracellular environments, and finally causing apoptosis, thereby achieving a durable therapeutic purpose.

According to an embodiment of the present invention, a pulsed electric field ablation needle is provided. The pulsed electric field ablation needle includes: a needle cannula for percutaneous penetration into muscle tissue; and the electrode is arranged on the needle tube and is used for conducting pulsed electric field ablation on muscle tissues.

Preferably, the pulsed electric field ablation needle according to the embodiment of the invention further comprises a needle tube insulating sleeve which is wrapped outside the needle tube. The electrode is disposed outside the needle cannula insulating sheath.

Preferably, the pulsed electric field ablation needle according to an embodiment of the present invention may further comprise: the handle is connected to the needle tube and used for controlling the needle penetration depth of the needle tube; a connector for connecting the electrode with the pulse generating device to effect transfer of energy; and the connecting wire is arranged between the connector and the handle and is used for transmitting pulse ablation energy.

In the pulsed electric field ablation needle according to embodiments of the present invention, the electrode may be of annular configuration, surrounding the outside of the needle tube insulation sleeve.

In the pulsed electric field ablation needle according to an embodiment of the present invention, the electrode may include a plurality of electrodes uniformly distributed outside the needle tube insulation sleeve.

Preferably, the number of the plurality of electrodes may be 2 to 10. More preferably, the number of the plurality of electrodes is 4.

Preferably, the polarities between adjacent two electrodes are opposite.

Preferably, the spacing between adjacent two electrodes is 1.5-6 mm.

In the pulsed electric field ablation needle according to an embodiment of the present invention, the electrode may include a plurality of ring electrodes having the same size and uniformly distributed outside the needle tube insulation sleeve.

In the pulsed electric field ablation needle according to the embodiment of the invention, the pulse amplitude voltage for performing pulsed electric field ablation on muscle tissue is 1000-4000V.

Preferably, the pulsed electric field ablation needle has a diameter of 0.5-2 mm.

Preferably, the cross-sectional area of the pulsed electric field ablation needle is 3-12 square millimeters. More preferably, the pulsed electric field ablation needle has a cross-sectional area of 5-10 square millimeters.

In the pulsed electric field ablation needle according to an embodiment of the present invention, the head end of the needle cannula may be a non-destructive tip. Preferably, the shape of the head end of the needle tube may be one of: sealed bullet, nib, blunt.

Preferably, the pulsed electric field ablation needle according to an embodiment of the present invention may further comprise: the filling hole is arranged on the needle tube insulating sleeve and is communicated with the inside of the needle tube.

Preferably, the priming aperture may be provided between adjacent two electrodes, leading to the interior of the needle cannula.

Alternatively, the priming aperture may be provided between the head end of the syringe and the electrode closest to the head end of the syringe, leading to the interior of the syringe.

Preferably, the pulsed electric field ablation needle may further comprise: a perfusion tube connected out from the handle for transporting perfusion gas or liquid; luer fittings, one end connected to a perfusion tube, and the other end connected to a source of perfusion gas or liquid.

Preferably, the perfusion gas is ozone.

The pulsed electric field ablation threshold has tissue specificity, muscle cells can be selectively treated by pulsed electric field technology, and the threshold is relatively low without affecting other non-target cell tissues (such as nerves, blood cells and the like). Meanwhile, as the energy release time is extremely short, the pulse technology can not generate a thermal effect, so that the problems of muscle tissue crusting, tissue blasting and the like are avoided.

Drawings

The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings, wherein like elements are numbered alike, wherein:

fig. 1 is an overall schematic of a pulsed electric field ablation needle in accordance with the present invention.

Fig. 2 is a partial schematic view of a head end section of a pulsed electric field ablation needle.

Fig. 3 is a schematic diagram of the distribution of ring electrodes on a pulsed electric field ablation needle.

Fig. 4 is a schematic view of the tip structure of the needle tube.

Fig. 5 is an overall schematic of a pulsed electric field ablation needle with irrigation holes.

FIG. 6 is a partial schematic view of a cross-section of a needle cannula head with an irrigation port.

Reference numerals

11-electrode

13-needle tube

14-handle

15-connecting line

16-connector

17-filling hole

18-perfusion channel

19-perfusion extension tube

20-luer fitting

21-needle tube insulating sleeve

22-electrode wire

Detailed Description

The technical scheme of the present invention will be described in further detail below by way of examples with reference to the accompanying drawings, but the present invention is not limited to the following examples.

As described above, the pulsed electric field ablation needle according to the present invention can be used for treating muscle hypertrophy. Those skilled in the art will appreciate that pulsed electric field ablation needles may be used for other purposes in addition to treating muscle hypertrophy. Therapeutically, the ablation needle may be inserted through a minimally invasive opening in the skin and into the body tissue. And applying pulse electric field energy to the tissue to be ablated through the electrode on the ablation needle, so as to achieve the purpose of ablating muscle tissue.

Thus, from a core point of view, the pulsed electric field ablation needle according to the present invention comprises at least a needle cannula and an electrode. The needle cannula may be percutaneously pierced into muscle tissue. The electrode is arranged on the needle tube, so that the pulse electric field ablation can be performed on muscle tissues.

Because of the high insulation requirements between the electrodes and the needle tube, the pulsed electric field ablation needle according to the invention further comprises a needle tube insulation sleeve. The needle tube insulating sleeve can be wrapped outside the needle tube, and the electrode is arranged outside the needle tube insulating sleeve.

As shown in fig. 1, in a preferred embodiment of the present invention, the pulsed electric field ablation needle may include an electrode 11, a needle tube 13, a needle tube insulator 21, a handle 14, a connection wire 15, and a connector 16 from a unitary structure. The electrode 11 is arranged outside the needle insulating sheath 21 for pulsed electric field ablation. Needle cannula 13 is in the form of an elongate needle for guiding penetration of electrode 11 into muscle tissue. A handle 14 is connected to the needle cannula 13 for controlling the needle penetration depth of the needle cannula 13. The connector 16 is used to connect the electrodes with the pulse generating device to effect the transfer of energy.

The arrangement of the electrodes on the ablation needle is further described below with reference to fig. 2 and 3.

Fig. 2 is a partial schematic view of a head end section of a pulsed electric field ablation needle. Fig. 3 is a schematic diagram of the distribution of ring electrodes on a pulsed electric field ablation needle.

As shown in fig. 2, the electrode 11 is of annular configuration and surrounds the outside of the needle cannula 21. Preferably, the electrode 11 is composed of 304 stainless steel or platinum iridium alloy. A plurality of electrodes are uniformly distributed outside the needle tube insulating tube 21. The number of electrodes is 2 to 10, preferably 4. In a preferred embodiment of the invention, a plurality of ring electrodes of the same size and uniformly distributed on the outside of the needle cannula insulating sheath are employed. The electrode 11 is connected to the inside of the needle cannula 13 by an electrode lead 22 and further to the inside of the handle 14, the connection wire 15, the connector 16 and finally to the impulse generating device.

It will be appreciated by those skilled in the art that although in the preferred embodiment of the invention the number of electrodes may be plural, electrodes of the same size may be used and the distribution of the electrodes may be uniform, in practice only one electrode may be provided, or the distribution of the plurality of electrodes may not be uniform, or the sizes (or even the shapes) of the plurality of electrodes may not be exactly the same, so as to accommodate different applications.

According to electric field analysis, the electric field intensity on the electrode surface and between the electrodes has a remarkable relationship with the electrode distance and the electrode sectional area. The electric field intensity is greatest at the electrode surface and gradually decays outwards, and meanwhile, the field intensity gradually decays from the electrode to the center of the electrode. To ensure that there is sufficient field strength in depth and that the field strength in the middle of the electrodes is effective, the spacing and area of the electrodes need to be analyzed to determine the optimum parameter value. Too large a spacing can not form a continuous ablation zone, and too small a spacing is concentrated in field intensity and easy to generate ionization. In this case, the spacing between adjacent two electrodes is preferably 1.5 to 6 mm. The structural design application of the multiple electrodes can effectively increase the damage size and improve the ablation efficiency.

As shown in fig. 3, the polarities of the plurality of electrodes alternate positive and negative, and the polarities of the adjacent two electrodes are opposite. For example, in fig. 3, 8 ring electrodes (black in the drawing) are distributed on the needle tube in total, and the polarities of the electrodes are negative, positive, negative, and positive, respectively, from the head end of the needle tube. By adopting the electrode design structure, the stimulation effect can be obviously reduced. Particularly in such local anesthesia conditions, the electrode design structure is particularly important.

In another aspect, the present invention employs a surface area equivalent design to provide electrodes (electrodes of the same size) on the ablation needle, i.e., each ring electrode is uniform in size and surface area. Since the surface areas are equal, the applied energy can be uniformly distributed when discharging between the two positive and negative electrodes, and thus the problem of ionization caused by excessive concentration of energy can be avoided. Because the ring electrodes with the same size are adopted and are combined with the needle type matching application of the operation type, when the pulse amplitude voltage for carrying out pulse electric field ablation on muscle tissues is 1000-4000V, the diameter of the pulse needle is 0.5-2 mm, the applicable sectional area is 3-12 square mm, and the preferable value is 5-10 square mm.

Fig. 4 is a schematic view of the tip structure of the needle tube.

As shown in FIG. 4, the tip of the needle cannula 13 may be configured in the shape of a sealed bullet, nib, blunt tip, or the like. The edge of the tip is subjected to certain smooth overspray, so that sharp corners are avoided, and the tip of the needle tube can be made into a 'nondestructive' tip. In surgery, a small hole is made in the skin by minimally invasive surgery, and then the needle cannula is inserted into the muscle tissue. The lossless head end design can effectively avoid the damage of nerves, blood vessels and the like while being inserted into tissues.

A needle cannula insulating sheath 21 is interposed between the electrode 11 and the needle cannula 13. Since the pulsed ablation electric field has the characteristic of high voltage, the insulation strength between the electrodes, between the electrodes and the needle tube or between the electrodes and the inactive metal is required, and the material of the needle tube insulation sleeve is preferably polyimide, polyester or fluorinated polyethylene.

Further, as shown in fig. 5, the perfusion holes are added on the basis of the design described above. After surgery, it is often necessary to sterilize the patient with a gas or liquid in order to prevent internal infection, thus greatly reducing the chance of infection. For example, a commonly used disinfection perfusion gas is ozone. The pulsed electric field ablation needle with the perfusion function can be provided with a perfusion hole at the needle tube part. Specifically, a filling hole may be provided in the needle tube insulating sleeve to communicate with the inside of the needle tube. For example, a pulsed electric field ablation needle as shown in fig. 5 may include an electrode 11, a needle cannula 13, a handle 14, a connecting wire 15, a connector 16, an irrigation hole 17, an irrigation extension tube 19, a luer fitting 20, a cannula insulating sleeve 21. An irrigation extension tube 19 is connected from the handle 14 for delivering irrigation gas or liquid (e.g., ozone). The luer fitting is connected at one end to a perfusion tube and at the other end to a source of perfusion gas or liquid (e.g., ozone source). In a preferred embodiment of the invention, the irrigation hole, the irrigation extension tube, the luer fitting are used as a passageway for the infusion of ozone.

As shown in fig. 6, the irrigation hole 17 may be positioned to open into the interior of the needle cannula 13 before the tip electrode, i.e., between the tip of the needle cannula and the electrode 11 closest to the tip of the needle cannula, and/or between adjacent electrodes, through the cannula insulator 21. A perfusion channel 18 is provided inside the needle tube 13 for delivering perfusion gas or liquid from a perfusion extension tube 19 to the respective perfusion holes 17. Electrode lead 22 is led out from the lower part of the electrode 11, penetrates through the needle tube insulating sleeve 21 and is communicated to the inside of the needle tube 13, but is isolated from the perfusion channel 18. After each pulse electric field ablation, the position of the pulse electrode needle is not required to be moved, so that ozone perfusion can be performed at the ablation position, and the operation is simple and convenient.

Application example 1 (single needle use):

the first step: performing B ultrasonic and CT examination before operation, measuring the thickness of muscle tissue, and determining the hypertrophy degree of the muscle tissue;

and a second step of: the operation is performed under local anesthesia. Inserting a needle at the front edge of the muscle tissue at one side, and inserting a pulsed electric field ablation needle into the muscle tissue;

and a third step of: inserting a pulsed electric field ablation needle to a desired depth position;

fourth step: selecting an activatable electrode according to an intended ablation range and performing pulsed electric field ablation;

fifth step: when the ablation size is longer and one ablation cannot cover a single treatment line, the pulsed electric field ablation needle can be withdrawn backwards for a certain distance (such as 1-2 cm), and pulse ablation is repeated until each treatment line is completed;

sixth step: moving the pulsed electric field ablation needle to the other side or other positions, then inserting the needle, repeating the above processes, and implementing pulsed electric field ablation;

seventh step: after the operation is finished, the pulsed electric field ablation needle is withdrawn.

Application example 2 (multi-needle use):

and a second step of: the operation is performed under local anesthesia, a plurality of pulsed electric field ablation needles are simultaneously inserted into muscle tissues and enter the expected appointed depth position;

fifth step: moving the pulsed electric field ablation needle to the other side or other positions, then inserting the needle, repeating the above processes, and implementing pulsed electric field ablation;

sixth step: after the operation is finished, the pulsed electric field ablation needle is withdrawn.

Advantageous effects

From the above description, it can be seen that the present invention includes at least the following advantageous effects:

1. the pulsed electric field ablation has tissue selectivity, avoids the damage of blood vessels and nerves, and reduces complications; in contrast, the traditional radio frequency ablation technology causes muscle tissue injury through physical heat effect, has no tissue specificity, and is easy to cause the injury of healthy tissues such as peripheral nerves, blood vessels and the like;

2. the pulsed electric field ablation solves the unsafe problem that the traditional radio frequency ablation is easy to overheat and damage in the tissue;

3. the irreversible penetrable damage is formed on the cell membrane due to the ablation of the pulse electric field, the effect is durable, and the problems of short acting time and non-durable effect of the botulinum toxin injection for treating the muscle hypertrophy are solved;

4. the pulse electric field ablation can realize simultaneous ablation of a plurality of electrodes/root electrodes, the pulse energy is controllable, the ablation area is controllable, and the safety is higher;

5. pulsed multi-electrode linear ablation may form a ribbon ablation zone.

The embodiments of the present invention are not limited to the examples described above, and those skilled in the art can make various changes and modifications in form and detail without departing from the spirit and scope of the present invention, which are considered to fall within the scope of the present invention.

Claims

1. A pulsed electric field ablation needle, the pulsed electric field ablation needle comprising:

a needle cannula for percutaneous penetration into muscle tissue;

and the electrode is arranged on the needle tube and is used for conducting pulsed electric field ablation on muscle tissues.

2. The pulsed electric field ablation needle of claim 1, further comprising:

the needle tube insulating sleeve is wrapped outside the needle tube,

wherein the electrode is arranged outside the needle tube insulating sleeve.

3. The pulsed electric field ablation needle of claim 2, further comprising:

the handle is connected to the needle tube and used for controlling the needle penetration depth of the needle tube;

a connector for connecting the electrode with the pulse generating device to effect transfer of energy;

and the connecting wire is arranged between the connector and the handle and is used for transmitting pulse ablation energy.

4. The pulsed electric field ablation needle of claim 2, wherein the electrode is of annular configuration surrounding the needle tube insulation sleeve.

5. The pulsed electric field ablation needle of claim 2, wherein the electrode comprises a plurality of electrodes uniformly distributed outside of the needle cannula insulation sheath.

6. The pulsed electric field ablation needle of claim 5, wherein the number of the plurality of electrodes is 2-10.

7. The pulsed electric field ablation needle of claim 6, wherein the number of the plurality of electrodes is 4.

8. The pulsed electric field ablation needle of claim 5, wherein polarities between adjacent two electrodes are opposite.

9. The pulsed electric field ablation needle of claim 5, wherein a spacing between adjacent two electrodes is 1.5-6 millimeters.

10. The pulsed electric field ablation needle of claim 4, wherein the electrode comprises a plurality of ring electrodes of the same size and uniformly distributed outside the needle cannula insulation sheath.

11. The pulsed electric field ablation needle of claim 1, wherein the pulsed electric field ablation of the muscle tissue has a pulse amplitude voltage of 1000-4000V.

12. The pulsed electric field ablation needle of claim 1, wherein the pulsed electric field ablation needle has a diameter of 0.5-2 millimeters.

13. The pulsed electric field ablation needle of claim 1, wherein the pulsed electric field ablation needle has a cross-sectional area of 3-12 square millimeters.

14. The pulsed electric field ablation needle of claim 13, wherein the pulsed electric field ablation needle has a cross-sectional area of 5-10 square millimeters.

15. The pulsed electric field ablation needle of claim 1, wherein the needle cannula head end is a non-destructive tip.

16. The pulsed electric field ablation needle of claim 15, wherein the needle cannula head end is one of: sealed bullet, nib, blunt.

17. The pulsed electric field ablation needle of claim 2, further comprising:

the filling hole is arranged on the needle tube insulating sleeve and is communicated with the inside of the needle tube.

18. The pulsed electric field ablation needle of claim 5, further comprising:

and the filling hole is arranged between two adjacent electrodes and communicated with the inside of the needle tube.

19. The pulsed electric field ablation needle of claim 5, further comprising:

the filling hole is arranged between the head end of the needle tube and the electrode closest to the head end of the needle tube and is communicated with the interior of the needle tube.

20. The pulsed electric field ablation needle of claim 17, further comprising:

a perfusion tube connected out from the handle for transporting perfusion gas or liquid;

luer fittings, one end connected to a perfusion tube, and the other end connected to a source of perfusion gas or liquid.

21. The pulsed electric field ablation needle of claim 20, wherein the irrigation gas is ozone.