CN211934280U - Integrated ablation needle and ablation system - Google Patents

Abstract

The utility model provides an integrated form melts needle, wear to adorn in including sleeve pipe and activity electrode needle in the sleeve pipe, electrode needle including the needle point that is located the distal end and connect in the needle bar of needle point near-end, the needle bar is being close to at least the sample groove is seted up at the position of needle point, the sheathed tube distal end sets up the blade. The cannula is axially moved relative to the needle shaft to expose or cover the sampling slot; when the sampling slot is exposed, the tissue portion around the needle shaft enters the sampling slot; when the sampling groove is covered, the cutting edge cuts off tissues inside and outside the sampling groove so as to obtain the tissues in the sampling groove as biopsy samples. The utility model also provides an ablation system including the integrated form ablation needle. The utility model provides an integrated form melts needle and system of melting will melt, the biopsy function is integrated on same melting needle, need not the independent execution biopsy step, has avoided repeated puncture, reduces the damage to the human body, saves the operation time.

Description

Integrated ablation needle and ablation system

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to an integrated form melts needle and melts system.

Background

With the development of minimally invasive medical technology, ablation has been widely applied to the treatment of diseases such as tumors in the liver, kidney, soft tissue and other parts, and the operation principle is to insert a radio frequency ablation needle or a microwave ablation needle into a lesion, and then to cause local tissue of the lesion to generate high temperature through radio frequency energy or microwave energy, so that the tissue of the lesion coagulative necrosis is achieved to achieve the purpose of treatment. In order to know the effect of ablation therapy, it is necessary to take a tissue sample after ablation is completed and perform pathological analysis, i.e., biopsy.

In the prior art, an ablation needle and a biopsy needle are usually independent from each other, the ablation needle firstly penetrates into diseased tissue to perform ablation, the ablation needle is withdrawn from a human body after ablation is completed, and the biopsy needle then independently penetrates into the ablated tissue to perform sampling. Therefore, ablation and biopsy after ablation require two punctures, and repeated punctures aggravate the damage to human tissues and organs, increase the potential risk of the surgical procedure, and prolong the surgical time.

SUMMERY OF THE UTILITY MODEL

In view of this, the utility model provides an integrated form melts needle and ablation system melts, biopsy function integration on same melting needle, need not to carry out the biopsy step alone, has avoided repeated puncture, reduces the damage to the human body, saves the operation time.

In order to solve the technical problem, the utility model provides an integrated ablation needle, which comprises a sleeve and an electrode needle movably arranged in the sleeve in a penetrating way, wherein the electrode needle comprises a needle point positioned at the far end and a needle rod connected with the near end of the needle point, the needle rod is at least provided with a sampling groove at the position close to the needle point, and the far end of the sleeve is provided with a cutting edge; the cannula is axially moved relative to the needle shaft to expose or cover the sampling slot; when the sampling slot is exposed, a tissue portion surrounding the needle shaft enters the sampling slot; when the sampling groove is covered, the cutting edge cuts off tissues inside and outside the sampling groove so as to obtain the tissues in the sampling groove as biopsy samples.

The utility model also provides an ablation system, including aforementioned integrated form ablation needle and with the energy generation device that the electrode needle electricity of integrated form ablation needle is connected.

The utility model provides an integrated ablation needle and an ablation system, wherein the integrated ablation needle comprises a sleeve and an electrode needle movably arranged in the sleeve in a penetrating way, a needle rod of the electrode needle is provided with a sampling groove, and the far end of the sleeve is provided with a cutting edge; the electrode needle is electrically connected with the energy generating device to perform ablation operation, after the ablation operation is completed, the sleeve moves towards the near end to expose the sampling groove, so that the tissue part around the needle rod enters the sampling groove, the sleeve moves towards the far end to cover the sampling groove, and the cutting edge at the far end of the sleeve cuts off the tissues inside and outside the sampling groove, so that the tissues in the sampling groove are obtained as biopsy samples, therefore, the ablation and biopsy functions are integrated on the integrated ablation needle, the biopsy step is not required to be executed independently, repeated puncture is avoided, the damage to the human body is reduced, and the operation time is saved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic overall perspective view of an integrated ablation needle according to a first embodiment of the present invention.

Fig. 2 is an axial cross-sectional view of the bushing of fig. 1.

Fig. 3 is an enlarged schematic view of the portion III in fig. 2.

Fig. 4 is a perspective view of the electrode needle of fig. 1.

Fig. 5 is an axial sectional view of the electrode needle of fig. 4.

Fig. 6 is an axial cross-sectional view of the distal portion of the integrated ablation needle with the sampling slots of fig. 1 exposed.

Fig. 7 is an axial cross-sectional view of the distal portion of the integrated ablation needle with the sampling slots of fig. 1 capped.

Fig. 8 is a schematic view of the overall structure of the ablation system provided by the present invention.

Fig. 9-11 are schematic illustrations of a use procedure of the ablation system of fig. 8.

Fig. 12 is a partial structural schematic view of an integrated ablation needle according to a second embodiment of the present invention.

Fig. 13 is a schematic view of the distal portion of the cannula of fig. 12.

Fig. 14 is an axial cross-sectional view of a partial structure of an integrated ablation needle according to a third embodiment of the present invention.

Fig. 15 is an axial sectional view of the electrode needle of fig. 14.

Fig. 16 is an enlarged schematic view of the XV portion in fig. 14.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device in its natural state. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 1, the present invention provides an integrated ablation needle 100 for performing an ablation procedure and obtaining a biopsy sample after the ablation procedure is completed. The integrated ablation needle 100 comprises a sleeve 10 and an electrode needle 20 movably arranged in the sleeve 10. The electrode needle 20 comprises a needle point 21 at the distal end and a needle rod 23 connected to the proximal end of the needle point 21, and the needle rod 23 is provided with a sampling groove 231 at least at a part close to the needle point 21. The distal end of the cannula 10 is provided with a cutting edge 11. The cannula 10 is moved axially relative to the needle shaft 23 to expose or cover the sampling slot 231. In the utility model discloses, energy generating device such as radio frequency generator or microwave generator can be connected to electrode needle 20 electricity to melt the operation. After the ablation operation is completed, when the sampling groove 231 is exposed, the tissue portion around the needle shaft 23 enters the sampling groove 231; when the sampling groove 231 is closed, the cutting edge 11 cuts the tissue inside and outside the sampling groove 231, thereby obtaining the tissue inside the sampling groove 231 as a biopsy sample. Therefore, the integrated ablation needle 100 integrates ablation and biopsy functions, a biopsy step does not need to be executed independently, repeated puncture is avoided, damage to a human body is reduced, potential risks in the operation process are reduced, and operation time is saved.

Specifically, referring to fig. 2 and 3, the cannula 10 is a hollow circular tube, which includes an inner cavity 12 extending along an axial direction and penetrating through two ends for movably inserting the electrode needle 20 (see fig. 1). A circle of accommodating groove 13 is formed in the inner wall of the far end of the sleeve 10, and a first annular step 14 is formed at the joint of the accommodating groove 13 and the inner cavity 12; the distal end of the cannula 10 is further provided with the aforementioned cutting edge 11, which comprises a cutting edge surface 113 inclined relative to the axis of the cannula 10, the cutting edge surface 113 gradually approaches the axis of the cannula 10 from the proximal end to the distal end, a tangent of the cutting edge surface 113 forms a first included angle α with the axis of the cannula 10, and in order to ensure the sharpness of the cutting edge surface 113, in this embodiment, the angle range of the first included angle α is preferably 9 degrees to 17 degrees. Furthermore, in this embodiment, the plane of the distal end of the cutting-edge face 113 is perpendicular to the axis of the cannula 10, i.e. the distal port of the cannula 10 is a flat port.

Referring to fig. 4 and 5, the electrode needle 20 is substantially in the shape of a circular rod. The needle tip 21 comprises a puncture section 211 at the distal end and a connecting section 213 connected to the proximal end of the puncture section 211, and the needle shaft 23 is connected to the proximal end of the connecting section 213. Preferably, in this embodiment, the puncturing section 211 is in a sharp triangular pyramid shape or a sharp conical shape, which is beneficial to ensure that the puncturing section 211 has a better sharpness, so that the electrode needle 20 and the cannula 10 can puncture skin and tissue more easily after being combined. The connecting section 213 is cylindrical, the diameter of the connecting section 213 is larger than that of the needle bar 23, and a second annular step 25 is formed at the joint of the connecting section 213 and the needle bar 23. Further, in the present invention, in order to obtain a biopsy sample after the ablation operation is completed, the needle bar 23 is at least provided with the sampling groove 231 at a position close to the needle tip 21. Specifically, in this embodiment, the sampling groove 231 is a strip-shaped groove extending along the axial direction of the needle rod 23, and the cross section of the sampling groove 231 perpendicular to the axial direction of the needle rod 23 is semicircular, that is, a half of the rod body of the needle rod 23 is removed in the axial direction at a position close to the needle point 21 to form the sampling groove 231, and the sampling groove 231 has a larger sampling space, which is beneficial for the tissues around the needle rod 23 to enter the sampling groove 231. Of course, in other embodiments, the cross section of the sampling groove 231 perpendicular to the axial direction of the needle bar 23 may be in a fan shape, a rectangular shape, or other shapes as long as the cross section can accommodate the tissue around the needle bar 23.

In other embodiments, the sampling groove 231 may be a plurality of strip-shaped grooves extending along the axial direction of the needle bar 23, and the plurality of strip-shaped grooves are spaced along the circumferential direction or the axial direction of the needle bar 23.

In other embodiments, the sampling groove 231 may also be one or several arc-shaped grooves extending along the circumferential direction of the needle bar 23, and the several arc-shaped grooves are spaced along the circumferential direction or the axial direction of the needle bar 23.

In other embodiments, the sampling groove 231 may also be one or several annular grooves extending along the circumference of the needle bar 23, and the several annular grooves are spaced along the axial direction of the needle bar 23.

Referring to fig. 1, the integrated ablation needle 100 further includes a handle 30 connected to the proximal end of the sleeve 10 and the proximal end of the electrode needle 20, wherein the handle 30 is used for driving the sleeve 10 to move axially relative to the needle shaft 23 so as to expose or cover the sampling slot 231.

Specifically, as shown in fig. 1, the proximal end of the sleeve 10 is fixedly connected to the driving mechanism inside the handle 30 by an integral injection molding or bonding connection, and the proximal end of the sleeve 10 protrudes from the proximal end of the handle 30; the needle point 21 of the electrode needle 20 is located outside the casing 10, the needle rod 23 of the electrode needle 20 is movably inserted into the casing 10, the proximal end of the needle rod 23 passes through the proximal end of the handle 30 from inside the casing 10, the proximal end of the needle rod 23 passes through the proximal end of the casing 10, and the proximal end of the needle rod 23 is externally connected to an energy generation device (not shown) such as a radio frequency generator or a microwave generator through an electrode wire 27, so that the needle point 21 located at the distal end of the electrode needle 20 outside the casing 10 can be used for ablation operation. Specifically, when the electrode needle 20 is electrically connected to the radio frequency generator, the electrode needle 20 transmits high-frequency current to enable positive and negative ions with charges around the distal end of the electrode needle 20 to generate high-speed oscillation motion, and the high-speed oscillation ions generate a large amount of heat due to friction, so that the temperature in the lesion tissue is increased, and finally, proteins in lesion cells are denatured, water inside and outside the cells is lost, and the lesion tissue is coagulative necrotic, thereby realizing radio frequency ablation; when the electrode needle 20 is electrically connected with a microwave generator, a microwave field is formed at the far end of the electrode needle 20, dipole molecules such as water molecules and the like in the pathological change tissue generate heat under the action of the microwave field due to motion friction and violent collision, so that the temperature in the pathological change tissue is raised, finally, protein in the pathological change cell is denatured, water inside and outside the cell is lost, and the pathological change tissue is coagulative and necrotic, thereby realizing microwave ablation. In this embodiment, the electrode needle 20 is preferably made of biocompatible metal with excellent electrical conductivity, such as stainless steel, the proximal end of the needle shaft 23 is electrically connected to a radio frequency generator through the electrode wire 27, and the needle tip 21 is used for radio frequency ablation.

As mentioned above, the proximal end of the cannula 10 is fixedly connected to the driving mechanism in the handle 30, and the needle shaft 23 is movably inserted into the cannula 10, so that moving the driving mechanism in the handle 30 in the axial direction moves the cannula 10 in the axial direction relative to the needle shaft 23, thereby exposing or covering the sampling slot 231 on the needle shaft 23 as required. Specifically, in some embodiments, when the driving mechanism in the handle 30 moves a certain distance proximally, the handle 30 drives the cannula 10 to move proximally until the sampling slot 231 is exposed, as shown in fig. 6; in some embodiments, when the driving mechanism in the handle 30 moves a certain distance distally, the handle 30 drives the cannula 10 to move distally until the sampling slot 231 is capped, as shown in fig. 7.

Optionally, a first positioning portion is disposed on the sleeve 10, and a second positioning portion is disposed on the electrode needle 20, and the first positioning portion and the second positioning portion cooperate to achieve positioning of the electrode needle 20 and the sleeve 10 in the axial direction, so as to indicate whether the sampling slot 231 is completely covered, and prevent the sampling slot 231 from being incompletely covered, which results in that tissues inside and outside the sampling slot 231 are not completely cut off.

Specifically, as shown in fig. 7, in this embodiment, the diameter of the inner cavity 12 of the cannula 10 is larger than the diameter of the needle shaft 23 and smaller than the diameter of the needle tip 21, and the diameter of the receiving groove 13 of the cannula 10 is larger than the diameter of the needle tip 21, so that when the handle 30 drives the cannula 10 to move continuously towards the distal end relative to the needle shaft 23, the first annular step 14 on the cannula 10 will eventually abut against the second annular step 25 on the electrode needle 20, at this time, the electrode needle 20 and the cannula 10 are positioned in the axial direction, the connecting section 213 at the proximal end of the needle tip 21 is partially received in the receiving groove 13 of the cannula 10, and the sampling groove 231 on the needle shaft 23 is completely covered. The first annular step 14 is the first positioning portion, and the second annular step 25 is the second positioning portion.

In other embodiments, the first positioning portion and the second positioning portion may be a first developing point and a second developing point, which are capable of being developed under a medical imaging device, the first developing point is disposed on an outer circumferential surface or an inner circumferential surface of the distal end of the sleeve 10 and is close to the cutting edge 11 of the distal end of the sleeve 10, the second developing point is disposed on an outer circumferential surface of the connecting section 213 of the needle tip 21 and is close to the sampling groove 213, an operator determines whether the sampling groove 231 is completely covered by observing relative positions of the first developing point and the second developing point under the medical imaging device, and determines that the sampling groove 231 is completely covered when the first developing point and the second developing point are overlapped or partially overlapped. Furthermore, the first visualization point and the second visualization point may also help an operator to determine whether the distal end of the electrode needle 20 reaches or is at a predetermined ablation position.

The first developing point and the second developing point can adopt developing modes such as ultrasonic development, X-ray fluoroscopy and the like, and preferably adopt an ultrasonic developing mode which has less damage to human bodies and is relatively economical.

It can be understood that the driving mechanism in the handle 30 drives the sleeve 10 to move axially relative to the needle shaft 23, which can be used to expose or cover the sampling slot 231, and can also be used to adjust the length of the distal end of the electrode needle 20 extending out of the sleeve 10, so as to change the effective ablation length of the integrated ablation needle 100 to adapt to different lesion sites or ablation requirements of different patients.

The sleeve 10 sleeved outside the electrode needle 20 is at least partially insulated, that is, the sleeve 10 may be completely insulated or partially insulated. When the sleeve 10 is completely insulated, the ablation operation is performed on the part of the distal end of the electrode needle 20 extending out of the sleeve 10, and the length of the part of the distal end of the electrode needle 20 extending out of the sleeve 10 is the effective ablation length of the integrated ablation needle 100; when the sleeve 10 is partially insulated, the ablation operation is performed on the part of the distal end of the electrode needle 20 extending out of the sleeve 10 and the non-insulated part of the sleeve 10, and the sum of the lengths of the part of the distal end of the electrode needle 20 extending out of the sleeve 10 and the non-insulated part of the sleeve 10 is the effective ablation length of the integrated ablation needle 100. Preferably, in this embodiment, the bushing 10 is entirely insulated. The sleeve 10 may be made of an insulating material, such as a plastic tube capable of meeting the hardness requirement, such as PEEK, PI, or PA, and a ceramic tube such as high-alumina ceramic, steatite ceramic, or boron nitride; the sleeve 10 may also be made entirely of non-insulating material and then covered with an insulating coating on the outer surface of the sleeve 10. In this embodiment, in order to improve the support of the cannula 10 and facilitate the penetration into the human tissue, it is preferable that the cannula 10 is made of a metal material, and the outer surface of the tube body is coated with an insulating coating, the metal material includes, but is not limited to, 304 stainless steel, 321 stainless steel or 631 stainless steel, and the insulating coating includes, but is not limited to, a PTFE coating, a titanium nitride coating, a parylene coating, and the like. The metal material for making the cannula 10 should have sufficient hardness to penetrate into the human tissue, and at the same time, it needs to have excellent biocompatibility, the insulating coating needs to have reliable insulating property, excellent biocompatibility and smaller friction coefficient, and it needs to be tightly combined with the outer surface of the cannula body of the cannula 10, and the insulating coating is not easy to fall off, for example, 304 stainless steel pipe plus PTFE coating, 304 stainless steel pipe plus parylene coating, 321 stainless steel pipe plus titanium nitride coating, or 631 stainless steel pipe plus parylene coating, etc. can be selected. Considering the insulation reliability and the process feasibility, the thickness of various insulation coatings is more than or equal to 3 μm.

Obviously, in other embodiments, the sleeve 10 may be partially insulated, so that the non-insulated part of the sleeve 10 may also transmit high frequency current or microwaves, which is beneficial for increasing the ablation area.

Referring to fig. 1 and 7, as mentioned above, after the electrode needle 20 is electrically connected to the rf generator or the microwave generator, the portion of the electrode needle 20 contacting the tissue may transmit rf energy or microwave energy to cause local tissue of the lesion to generate high temperature, so that the local tissue of the lesion is coagulatively necrotic to achieve the therapeutic purpose, but the local high temperature may affect normal tissue that does not need ablation, therefore, in the present invention, a cooling channel 233 is formed in the electrode needle 20, and the cooling channel 233 is used for delivering a gaseous or liquid cooling medium (such as cooling water) to cool down, so as to control the temperature during the ablation operation.

Specifically, as shown in FIG. 1, the cooling channel 233 is a cylindrical channel, the cooling channel 233 extending from the proximal end surface of the needle shaft 23 to the interior of the needle tip 21. The proximal end of the sleeve 10 and the proximal end of the electrode needle 20 are both communicated with a negative pressure device 40, so that the negative pressure device 40 is communicated with the cooling channel 233, the proximal end of the negative pressure device 40 is provided with a pair of circulation pipes 45, and the circulation pipes 45 are externally connected with a cooling medium supply device (not shown) to provide sufficient cooling medium and ensure that the ablation temperature is maintained in an ideal state. Optionally, a temperature measuring element 50 extending into the needle tip 21 is installed in the cooling channel 233 to obtain the ablation temperature in real time. In this embodiment, the temperature measuring element 50 is a temperature measuring conducting wire extending into the needle tip 21.

As shown in fig. 7, in this embodiment, the cooling channel 233 is preferably communicated with the sampling slot 231, so that when the sleeve 10 covers the sampling slot 231 and the electrode needle 20 performs ablation, a cooling medium can flow into between the sleeve 10 and the electrode needle 20 through the sampling slot 231, so that the cooling effect is more uniform, and more preferably, in this embodiment, the diameter of the needle rod 23 is smaller than the diameter of the inner cavity 12 of the sleeve 10, so that a flow space outside the cooling channel 233 can be provided for the cooling medium, and the cooling effect is faster.

Further, in order to prevent the cooling medium from leaking out of the radial gap between the cannula 10 and the needle shaft 23 during ablation, a sealing mechanism is provided on the cannula 10 and/or the needle shaft 23 to seal the radial gap between the cannula 10 and the needle shaft 23, and the sealing mechanism is located between the sampling groove 231 and the needle tip 21 when the sampling groove 231 is covered by the cannula 10. Specifically, referring to fig. 5 and fig. 7, in the present embodiment, a circle of sealing groove 235 is formed at a position of the needle rod 23 close to the needle tip 21, the sealing groove 235 is located between the sampling groove 231 and the needle tip 21, a sealing ring 60 is sleeved in the sealing groove 235, and the sealing groove 235 and the sealing ring 60 form the sealing mechanism. The sealing ring 60 has elasticity, and the outer diameter of the sealing ring 60 is slightly larger than the diameter of the inner cavity 12 of the sleeve 10, so that after the electrode needle 20 is matched with the sleeve 10, the sealing ring 60 is elastically deformed, and can be tightly attached to the inner circumferential surface of the sleeve 10, and a better sealing effect is achieved.

In other embodiments, the needle 23 may be provided with a plurality of sealing grooves 235 along the axial direction at a position close to the needle tip 21, and a sealing ring 60 is disposed in each sealing groove 235 to enhance the sealing effect.

Referring to fig. 8, the present invention further provides an ablation system 1000, which includes the integrated ablation needle 100 and an energy generating device 200 electrically connected to the electrode needle 20 of the integrated ablation needle 100. The energy generating device 200 includes, but is not limited to, a radio frequency generator or a microwave generator, in this embodiment, the energy generator 200 is a radio frequency generator, and the radio frequency generator is electrically connected to the electrode needle 20 through an electrode wire 27 and is configured to provide a high-frequency current to the electrode needle 20 for performing a radio frequency ablation operation.

Further, the ablation system 1000 further comprises a cooling medium supply device 300, wherein the cooling medium supply device 300 is communicated with the negative pressure device 40 of the integrated ablation needle 100 through a pair of circulation pipes 45, and further communicated with the cooling channel 233 of the electrode needle 20, so as to provide sufficient gaseous or liquid cooling medium into the cooling channel 233 for controlling the temperature of the integrated ablation needle 100 during the ablation operation.

Referring to fig. 1, 9-11, the following describes the use of the ablation system 1000 of the present invention:

the first step is as follows: as shown in fig. 9, the electrode needle 20 is first inserted into the casing 10, the electrode needle 20 and the casing 10 are in a closed state, so that the casing 10 completely covers the sampling slot 231 on the needle rod 23, and a complete sealing state is ensured between the casing 10 and the electrode needle 20 under the action of the sealing ring. Under the guidance of ultrasonic development, the sleeve 10 and the electrode needle 20 in a closed state reach a lesion part of a human body through the puncture of a needle point 21, high-frequency current is provided to the electrode needle 20 through an energy generating device 200 (see fig. 8), the needle point 21 at the far end of the electrode needle 20 discharges electricity to carry out radio frequency ablation on the lesion part, a temperature measuring element 50 (see fig. 7) monitors ablation temperature in real time, and a cooling medium supplying device 300 (see fig. 8) introduces a cooling medium into a cooling channel 233 of the electrode needle 20 to realize circulating cooling.

The second step is that: after the ablation is completed, the cooling medium supply device 300 is closed, the negative pressure device 40 is opened, and the cooling medium is completely sucked and removed by the negative pressure effect. After the cooling medium is completely discharged by the negative pressure device 40, the operation handle 30 drives the sleeve 10 connected thereto to move toward the proximal end with respect to the needle shaft 23 of the electrode needle 20, completely or partially exposing the sampling groove 231, at which time the ablated tissue around the needle shaft 23 will partially enter the sampling groove 231, and due to the continuous operation of the negative pressure device 40, a negative pressure will also be generated to the tissue, so that the tissue is sucked into the sampling groove 231, as shown in fig. 10.

The third step: then the handle 30 is manipulated to move the cannula 10 distally relative to the needle shaft 23 of the electrode needle 20, completely cover the sampling slot 231, and the cutting edge 11 at the distal end of the cannula 10 is used to cut off the tissue inside and outside the sampling slot 231, so that the tissue inside the sampling slot 231 is cut and separated from other tissue and remains in the sampling slot 231, as shown in fig. 11. Finally, the entire integrated ablation needle 100 is withdrawn from the body, and the tissue in the sampling groove 231 is removed to be used as a biopsy sample for examination and analysis.

The utility model provides an integrated form melts needle 100 reaches it melts system 1000, will melt, biopsy function integration on same melting needle, need not to carry out the biopsy step alone, has avoided repeated puncture, reduces the damage to the human body, reduces the potential risk among the operation process, saves the operation time.

Referring to fig. 12 and 13, an integrated ablation needle 100b according to a second embodiment of the present invention is similar to the integrated ablation needle 100 of the first embodiment, except that: in a second embodiment, the plane of the distal end of the cutting facet 113b is at a second angle β to the axis of the cannula 10b, i.e. the distal mouth of the cannula 10b is a beveled tip. In this embodiment, the beveled tip cuts tissue with a smaller contact area of the distal end of the cutting edge face 113b with the tissue than with a straight port, and the smaller contact area allows the cutting edge face 113b to more easily cut tissue with the same trigger force.

In order to ensure the sharpness of the cutting edge surface 113b during cutting, in this embodiment, the angle range of the second included angle β is preferably 25 degrees to 35 degrees.

Referring to fig. 14 to 16, an integrated ablation needle 100c according to a third embodiment of the present invention is similar to the integrated ablation needle 100 of the first embodiment, except that: in a third embodiment, the integrated ablation needle 100c further includes an outer tube 70 threaded outside the sleeve 10, and the electrode needle 20 and the sleeve 10 are axially movable relative to the outer tube 70, so that the integrated ablation needle 100c can perform pre-ablation biopsy, ablation, and post-ablation biopsy by one puncture.

Specifically, when the integrated ablation needle 100c is used, the outer tube 70 is sleeved outside the sleeve 10 and is penetrated into the lesion tissue together with the sleeve 10 and the electrode needle 20 which are penetrated together, and before an ablation operation is performed, the outer tube 70 is moved axially and proximally relative to the sleeve 10 and the electrode needle 20, so that the distal end portions of the sleeve 10 and the electrode needle 20 which are penetrated together are exposed; then controlling the sleeve 10 to move axially relative to the electrode needle 20 to obtain a tissue sample before ablation, withdrawing the sleeve 10 and the electrode needle 20 which are threaded together from the outer tube 70, leaving the outer tube 70 in the tissue, and taking out the tissue sample before ablation in the sampling groove 231 of the electrode needle 20; then, the sleeve 10 and the electrode needle 20 which are penetrated together enter a lesion tissue part by taking the outer tube 70 which is left in the tissue as a channel, ablation is performed, after the ablation, the sleeve 10 is controlled to move axially relative to the electrode needle 20 again to obtain an ablated tissue sample, and finally the outer tube 70, the sleeve 10 and the electrode needle 20 are together withdrawn out of the body.

In order to avoid the excessive resistance in the puncturing process caused by the excessive outer diameter of the integrated ablation needle 100c after the outer tube 70 is added, in this embodiment, a circle of avoiding groove 237 is circumferentially formed at the proximal end of the needle tip 21, the second annular step 25 is formed at the connection position of the avoiding groove 237 and the sealing groove 235 on the needle bar 23, when the cannula 10 is axially positioned relative to the electrode needle 20, the first annular step 14 (not shown) of the cannula 10 abuts against the second annular step 25, the cutting edge 11 of the cannula 10 is accommodated in the avoiding groove 237, and the outer diameter of the cannula 10 is equal to or smaller than the diameter of the proximal end of the needle tip 21, so that after the outer tube 70 is sleeved on the cannula 10, the entire outer diameter of the integrated ablation needle 100c is not increased to facilitate puncturing; furthermore, the cutting edge 11 of the sleeve 10 is accommodated in the avoiding groove 237, which is also beneficial to protecting the cutting edge 11 of the sleeve 10.

Preferably, the distal end of the outer tube 70 is provided with a bevel 71, the bevel 71 gradually approaches the axis of the outer tube 70 from the proximal end to the distal end, and the bevel 71 can reduce the resistance to the entry of the outer tube 70 into the tissue, thereby facilitating the puncture.

In this embodiment, the outer tube 70 is additionally arranged outside the sleeve 10, after the outer tube 70 is inserted into the tissue along with the sleeve 10 and the electrode needle 20 which are assembled together, the outer tube 70 is left in the tissue, and can be used as a channel for biopsy before ablation, biopsy after ablation, so that repeated insertion is avoided, damage to the tissue of the human body can be reduced, potential risks in the operation process can be reduced, and the operation time can be saved.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (19)

1. An integrated ablation needle is characterized by comprising a sleeve and an electrode needle movably arranged in the sleeve in a penetrating mode, wherein the electrode needle comprises a needle point positioned at the far end and a needle rod connected to the near end of the needle point, a sampling groove is formed in at least the position, close to the needle point, of the needle rod, and a cutting edge is arranged at the far end of the sleeve;

the cannula is axially moved relative to the needle shaft to expose or cover the sampling slot; when the sampling slot is exposed, a tissue portion surrounding the needle shaft enters the sampling slot; when the sampling groove is covered, the cutting edge cuts off tissues inside and outside the sampling groove so as to obtain the tissues in the sampling groove as biopsy samples.

2. The integrated ablation needle of claim 1, wherein the cannula is at least partially insulated.

3. The integrated ablation needle of claim 1, wherein the sampling groove is one or more strip grooves extending in an axial direction of the needle shaft, the strip grooves being spaced circumferentially or axially of the needle shaft.

4. The integrated ablation needle of claim 1, wherein the sampling slot is one or more arcuate grooves extending circumferentially along the needle shaft, the arcuate grooves being spaced circumferentially or axially along the needle shaft.

5. The integrated ablation needle of claim 1, wherein the sampling groove is one or more annular grooves extending circumferentially around the needle shaft, the annular grooves being spaced axially along the needle shaft.

6. The integrated ablation needle of claim 1 wherein the cutting edge comprises a cutting edge facet inclined relative to the axis of the cannula, the cutting edge facet progressively approaching the axis of the cannula from the proximal end to the distal end thereof, a tangent to the cutting edge facet making a first included angle with the axis of the cannula, the first included angle being in the range of 9 degrees to 17 degrees.

7. The integrated ablation needle of claim 6, wherein the distal end of the cutting-edge face lies in a plane perpendicular to the axis of the cannula; or the plane of the distal end of the cutting edge face forms a second included angle with the axis of the sleeve, and the angle range of the second included angle is 25-35 degrees.

8. The integrated ablation needle according to claim 1, wherein a first positioning portion is provided on the sleeve, and a second positioning portion is provided on the electrode needle, and the first positioning portion and the second positioning portion cooperate to axially position the electrode needle and the sleeve.

9. The integrated ablation needle according to claim 8, wherein a ring of receiving grooves is formed in an inner wall of the distal end of the sleeve, a first annular step is formed at a junction of the inner cavity of the sleeve and the receiving grooves, and the first positioning portion is the first annular step; the diameter of the proximal end of the needle point is larger than that of the needle rod, a second annular step is formed at the joint of the proximal end of the needle point and the needle rod, and the second positioning part is the second annular step; when the first annular step abuts against the second annular step, the electrode needle and the sleeve are axially positioned, and the proximal end portion of the needle tip is contained in the containing groove.

10. The integrated ablation needle of claim 1, wherein the electrode needle has cooling channels formed therein extending axially from its proximal end face to an interior of the needle tip.

11. The integrated ablation needle of claim 10, wherein the cooling channel is in communication with the sampling slot, the outer diameter of the needle shaft being less than the inner diameter of the cannula.

12. The integrated ablation needle of claim 11, wherein the cannula and/or the needle shaft is provided with a sealing mechanism to seal a radial gap between the cannula and the needle shaft, and wherein the sealing mechanism is located between the sampling slot and the needle tip when the sampling slot is capped by the cannula.

13. The integrated ablation needle according to claim 12, wherein the needle shaft is provided with at least one sealing groove at a position close to the needle tip, the sealing groove is located between the sampling groove and the needle tip, a sealing ring is sleeved in the sealing groove, and the sealing groove and the sealing ring form the sealing mechanism.

14. The integrated ablation needle of claim 13, wherein the cooling channel houses a temperature sensing element extending into the interior of the tip.

15. The integrated ablation needle of claim 11, wherein the proximal end of the cannula and the proximal end of the electrode needle are each in communication with a negative pressure device.

16. The integrated ablation needle of claim 1 further comprising a handle connected to the proximal end of the cannula and the proximal end of the electrode needle, the handle configured to move the cannula axially relative to the needle shaft.

17. The integrated ablation needle according to any of claims 1 to 16, further comprising an outer tube threaded outside the sheath, wherein the electrode needle and the sheath are axially movable relative to the outer tube.

18. The integrated ablation needle of claim 17, wherein the proximal end of the needle tip is circumferentially provided with a circumferential avoidance groove, the cutting edge of the sleeve is received in the avoidance groove when the sleeve is axially positioned with respect to the electrode needle, and the outer diameter of the sleeve is equal to or less than the diameter of the proximal end of the needle tip.

19. An ablation system comprising an integrated ablation needle according to any one of claims 1 to 18 and an energy generating device electrically connected to the electrode needle of the integrated ablation needle.

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