CN219331890U

CN219331890U - Energy delivery device

Info

Publication number: CN219331890U
Application number: CN202223067057.2U
Authority: CN
Inventors: 张芳芳; 姚佳星; 陶霖; 许书菡; 杨勇; 叶萍
Original assignee: Ronghe Medical Technology Zhejiang Co ltd
Current assignee: Ronghe Medical Technology Zhejiang Co ltd
Priority date: 2022-11-18
Filing date: 2022-11-18
Publication date: 2023-07-14
Anticipated expiration: 2032-11-18

Abstract

The utility model discloses an energy delivery device, which comprises a guide tube, an expandable structure, an energy delivery assembly and an operating handle, one end of the guide tube is connected with the operating handle, and the other end of the guide tube is connected with the expandable structure; a cooling medium channel is formed in the guide pipe, one end of the cooling medium channel is used for communicating with a cooling medium source, the other end of the cooling medium channel is communicated with the expandable structure; the energy delivery assembly includes a delivery wire and a flexible electrode, one end of the conveying line is connected with the flexible electrode, the other end of the conveying line is used for being connected with an energy supply device, the flexible electrode is in a net shape, and the flexible electrode covers the expandable structure. The energy delivery device has the advantages of simple structure, simple operation steps, more uniform fit with the target area and better treatment effect.

Description

Energy delivery device

Technical Field

The utility model relates to the technical field of medical equipment, in particular to an energy delivery device.

Background

In recent years, a process for producing a plastic film, the use of pulsed electric fields in the biomedical field is becoming a hotspot for scientists to study. Among them, irreversible electroporation pulsed electric field ablation technology has made great progress in the treatment of malignant tumors. In irreversible electroporation, the tissue properties all exhibit a capacitive effect, while at the cellular level, the phospholipid bilayer of the cell is also equivalent to a capacitor. Therefore, the process of applying a pulse electric field to cells is a process of charging cell membranes, when the transmembrane potential is higher than a certain threshold value, breakdown occurs, namely, the cell membranes are perforated and cannot be recovered reversibly, intracellular substances leak out, and a large amount of extracellular moisture, metal ions and protein macromolecules flow in, so that the cells are finally caused to swell, break and die. By killing cancerous cells in this way, malignant tumors can be treated and the quality of life of the patient can be improved.

However, in the existing treatment, the multipoint ablation adopted by the irreversible electroporation pulse electric field ablation technology is difficult to form good adhesion with tissues, so that an instrument is required to be invented, pulse energy can be accurately delivered to a lesion position, pulse ablation is realized, the instrument has good adhesion with a lesion area, and surrounding normal tissues are not damaged.

Disclosure of Invention

In order to solve the problems that an energy delivery device cannot reach an accurate position to form better adhesion with a target area and influence the treatment effect in the prior art.

The application provides an energy delivery device, which comprises a guide tube, an expandable structure, an energy delivery assembly and an operating handle, wherein one end of the guide tube is connected with the operating handle, and the other end of the guide tube is connected with the expandable structure;

a cooling medium channel is formed in the guide pipe, one end of the cooling medium channel is used for being communicated with a cooling medium source, and the other end of the cooling medium channel is communicated with the expandable structure;

the energy delivery assembly comprises a conveying line and a flexible electrode, one end of the conveying line is connected with the flexible electrode, the other end of the conveying line is used for being connected with an energy supply device, the flexible electrode is net-shaped, and the flexible electrode covers the expandable structure.

Further, one end of the guide tube, which is far away from the operating handle, is provided with a detection assembly.

Further, the guide tube includes an outer tube and an inner tube, and a cooling medium passage is formed between the outer tube and the inner tube.

Further, one end of the expandable structure, which is close to the operating handle, is connected with the outer layer tube, and the other end of the expandable structure is connected with the inner layer tube.

Further, the flexible electrode is of a quadrilateral mesh structure.

Further, the flexible electrode is cut, woven or electroformed.

Further, two ends of the flexible electrode are respectively connected with two ends of the expandable structure through connecting pieces.

Further, the flexible electrode is capable of expanding as the expandable structure expands and contracting as the expandable structure contracts.

Further, a communication part is arranged on the operating handle, and the communication part is respectively communicated with the cooling medium source and the cooling medium channel.

Further, the detection assembly is in communication with an extracorporeal detection apparatus.

The embodiment of the utility model has the following beneficial effects:

(1) The flexible electrode is net-shaped and coated on the surface of the expandable structure, and has a compact structure, higher tensile property and higher structural stability. After the expansion of the expandable structure is controlled, the joint area of the reticular flexible electrode and the target area is larger and more uniform, and the treatment effect is better. The guide pipe is a double-layer guide pipe and is provided with a cooling medium channel and a wire channel, so that the structure is more compact, and the redundancy that wires are exposed is avoided.

(2) The energy delivery device of the present application can guide the expandable structure and the energy delivery assembly to precisely reach the target area through the positioning and navigation of the detection assembly.

Drawings

In order to more clearly illustrate the technical solution of the present utility model, the following description will make a brief introduction to the drawings used in the description of the embodiments or the prior art. It is evident that the drawings in the following description are only some embodiments of the present utility model and that other drawings may be obtained from these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a top view of an energy delivery device according to an embodiment of the present utility model;

FIG. 2 is a schematic illustration of an energy delivery device according to an embodiment of the present utility model;

FIG. 3 is a detailed structural schematic diagram of an inflatable structure and an energy delivery assembly of an embodiment of the present utility model;

fig. 4 is a cross-sectional view of a guide tube 1 according to an embodiment of the present utility model.

Wherein, the reference numerals in the figures correspond to: 1-guide tube, 2-expandable structure, 3-energy delivery assembly, 4-handle, 41-communication, 11-outer tube, 12-inner tube, 13-cooling medium channel, 14-wire channel, 31-delivery wire, 32-flexible electrode, 321-connector, 5-detection assembly, 51-wire.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present utility model, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

In the description of the present utility model, it should be understood that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of description and simplification of the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present utility model. 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 or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may include one or more of the feature, either explicitly or implicitly.

In addition, in the present utility model, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and the like should be construed broadly, and may be fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.

Examples

The embodiment provides an energy delivery device, is used for accurate entering tissue areas such as tumour, lumen, organ, can form better subsides with the target area, and through energy delivery subassembly to the pulse energy of target area application, realize pulse ablation, do not damage surrounding normal tissue again. The target area is a lesion tissue area that needs to be treated by the pulse energy.

As shown in fig. 1 and 2, the energy delivery device of the present embodiment includes a guide tube 1, an expandable structure 2, an energy delivery assembly 3, and an operating handle 4. One end of the guide tube 1 is connected with the operation handle 4, and the other end of the guide tube 1 is connected with the expandable structure 2.

Specifically, the guide tube 1 is used to connect the operation handle 4 and the expandable structure 2. The guide tube 1 is formed therein with a cooling medium channel 13, one end of the cooling medium channel 13 being adapted to communicate with a cooling medium source, and the other end of the cooling medium channel 13 being adapted to communicate with the expandable structure 2.

In some embodiments, a cooling medium channel 13 is formed inside the guide tube 1, the cooling medium entering the expandable structure 2 through the cooling medium channel 13 inside the guide tube 1. As shown in fig. 4, in the present embodiment, the guide tube 1 includes an outer layer tube 11 and an inner layer tube 12, and a cooling medium passage 13 is formed between the outer layer tube 11 and the inner layer tube 12. A wire passage 14 is formed in the inner tube 12. The guide tube 1 is configured as a double-layer catheter, the inner tube 12 is hollow, and the cooling medium channel 13 and the wire channel 14 are formed at the same time, so that the structure is more compact.

Specifically, one end of the expandable structure 2 near the operation handle 4 is connected to the outer layer tube 11, and the other end of the expandable structure 2 is connected to the inner layer tube 12. The length of the inner layer tube 12 is longer than that of the outer layer tube 11, one end of the expandable structure 2, which is close to the operating handle 4, is connected with the outer layer tube 11, the other end of the expandable structure 2 is connected with the inner layer tube 12, cooling medium is input through one end of the expandable structure, which is connected with the outer layer tube, the end of the expandable structure, which is connected with the inner layer tube 12, is a closed end, and the cooling medium cannot be output. The cooling medium can be returned through the cooling medium channel 13 after it has been circulated through the cooling medium channel 13 between the outer tube 11 and the inner tube 12 into the expandable structure 2. The input and output channels of the cooling medium in this embodiment are the same channel, which is beneficial to precisely controlling the volume of the cooling medium input into the expandable structure 2 while simplifying the structure, thereby controlling the expansion degree of the expandable structure 2. The expandable structure 2 expands with the input of the cooling medium and contracts with the output of the cooling medium, allowing for better abutment and separation of the energy delivery assembly from the target area.

In some embodiments, the guide tube 1 may be a sheath tube. In particular, it may be a PEBAX tube or a nylon tube. The outer diameter of the outer layer tube 11 of the guide tube 1 is 1mm-5mm, the wall thickness of the outer layer tube 11 is 0.025mm-0.5mm, and the length is at least 40cm; the inner diameter of the inner tube 12 is 0.5mm-3mm, the wall thickness is 0.025mm-0.5mm, and the length is at least 40cm. In this example, the outer diameter of the outer layer tube 11 was 4mm, the wall thickness was 0.2mm, and the length was 60cm; the inner diameter of the inner tube 12 was 1.6mm, the wall thickness was 0.2mm, and the length was 68cm. In other embodiments, the guide tube 1 is connected to the expandable structure 2 and the energy delivery assembly 3 long enough to extend from outside the body to the target area for pulsed ablation therapy. Preferably, the length of the guide tube 1 may be at least 50cm, 60cm, 70cm, 80cm, 90cm, 100cm, 110cm, 120cm, 130cm, 140cm or a range of periods. The guide tube 1 has excellent bending resistance, can better meet the requirements of human complexity and bending property, and the inner wall of the guide tube 1 is smooth and has small friction resistance.

The cooling medium source is used to input the cooling medium into the cooling medium channel 13, and the cooling medium source may be a cooling medium injector or a cooling medium supply. In some embodiments, the source of cooling medium may control the volume and pressure of cooling medium input into the expandable structure 2. The present embodiment controls the expansion of the expandable structure 2 by inputting the cooling medium, and the expandable structure 2 contracts when the cooling medium is controlled to be output. The cooling medium includes, but is not limited to, one or more of the following or a combination thereof: water, sodium chloride solution, dextrose water solution, sodium lactate and compound sodium chloride solution, sodium bicarbonate and isotonic saline solution, and the like. In some embodiments, the cooling medium cools the surface of the expandable structure by absorbing heat.

In particular, the expandable structure 2 is configured as a bladder that can expand with the input of a cooling medium. In some embodiments, the expandable structure 2 may be expanded into one of a spherical balloon, an oval balloon, a conical balloon, a dumbbell-shaped balloon, or a cylindrical balloon. In some embodiments, the expandable structure 2 may be made of PU, PEBAX, or nylon, among other materials. The length of the expandable structure 2 is at least 5mm. Preferably, the length of the expandable structure 2 may be 6mm, 7mm, 8mm, 10mm, 12mm, 15mm, 16mm, 18mm, 20mm or a range therebetween. Preferably, the outer diameter of the expandable structure 2 is in the range of 4mm-10mm.

In particular, the handle 4 is a handle that controls the delivery of the expandable structure 2 and the energy delivery assembly 3 to the target area by the guide tube 1 for treatment. One end of the guide tube 2 is penetrated in the operation handle 4 and can be adhered with the operation handle 4 by glue such as quick-drying glue, UV glue, epoxy glue and the like. In some embodiments, the handle 4 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone. In the present embodiment, the operation lever 4 is provided with a communication portion 41, and the communication portion 41 communicates with the cooling medium source and the cooling medium passage 13, respectively. In some embodiments, the communication portion 41 may be a communication hole provided on the operation handle 4, through which the cooling medium source communicates with the cooling medium passage 13; in some embodiments, the communication portion 41 may be a connection pipe provided on the operation handle 4, through which the cooling medium source communicates with the cooling medium passage 13. In some embodiments, the connecting tube is integrally formed with the handle 4.

Specifically, as shown in fig. 3, the energy delivery assembly 3 includes a transmission line 31 and a flexible electrode 32, one end of the transmission line 31 is connected to the flexible electrode 32, the other end of the transmission line 31 is used for being connected to an energy supply device, the flexible electrode 32 is in a net shape, and the flexible electrode 32 covers the expandable structure 2.

Specifically, both ends of the flexible electrode 32 are connected to both ends of the expandable structure 2 through the connection 321, respectively. In some embodiments, the connector 321 may be a connection sleeve, preferably, a shrink tube or heat shrink tube. The two ends of the flexible electrode 32 of this embodiment may be fixedly connected to the two ends of the expandable structure 2 through heat shrink tubes, respectively. The flexible electrode 32 is capable of expanding with expansion of the expandable structure 2 and contracting with contraction of the expandable structure 2. When the expandable structure 2 is contracted, the flexible electrode 32 can enter the human body together with the expandable structure 2 along with the guide tube 1; after the expandable structure 2 is expanded, the flexible electrode 32 is tightly attached to the surface of the expandable structure 2, the surface of the flexible electrode 32 is uniformly attached to the target area, and the transmission line 31 is controlled to transmit pulse energy to the flexible electrode 32, so that pulse discharge is realized.

In particular, the transfer line 31 may be a stainless steel wire, copper wire or enameled wire. The wire diameter of the conveying wire 31 is 0.05mm-0.5mm. In some embodiments, the outer layer of the delivery wire 31 is sheathed with a PTFE heat shrink tube, a PET heat shrink tube, or a PI sheath. In other embodiments, the outer layer of the transfer wire 31 is also provided with a PTFE coating. The delivery line 31 is used to deliver pulsed energy to the flexible electrode 32.

Specifically, the flexible electrode 32 may be a quadrangular mesh structure. In some embodiments, the flexible electrode 32 may be a parallelogram mesh structure. Preferably, the flexible electrode 32 may be a diamond mesh structure. The quadrilateral mesh has instability and is easy to change shape, so that when the flexible electrode is of a quadrilateral mesh structure, the mesh is more compact, the tensile property and the structural stability are higher, the flexible electrode can be better attached to the surface of the expandable structure 2, and can expand and contract along with the expandable structure 2, and meanwhile, the attaching area of the mesh flexible electrode and a target area is larger and more uniform, and the treatment effect is better. In some embodiments, the flexible electrode 32 may be cut, woven, or electroformed. The flexible electrode 32 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or other materials with good electrical conductivity. The wire diameter of the mesh-like flexible electrode 32 is 0.05mm to 0.30mm. The length of the flexible electrode 32 is greater than the length of the expandable structure 2, the length of the flexible electrode 32 being at least 5mm. Preferably, the length of the flexible electrode 32 may be 6mm, 8mm, 10mm, 15mm, 18mm, 20mm or a range therebetween.

Specifically, the end of the guide tube 1 remote from the operating handle 4 is provided with a detection assembly 5. The detection assembly 5 of the present embodiment may be connected to the inner tube 12 of the guide tube 1. In some embodiments, the detection assembly 5 may be bonded to the guide tube 1 by a glue such as a quick-setting glue, a UV glue, an epoxy glue, or the like. In other embodiments, the detection component 5 may be further connected to the guide tube 1 through a heat shrink tube such as PU, PET, PTFE or PEEK.

In particular, the detection assembly 5 comprises at least one multi-degree of freedom magnetic positioning sensor. In one embodiment, the detection assembly 51 includes at least one five-degree-of-freedom magnetic positioning sensor or six-degree-of-freedom magnetic positioning sensor. The detection assembly 5 is in communication with an extracorporeal detection apparatus. In some embodiments, the detection assembly 5 is connected to an external detection device by a wire 51, and the wire 51 is used to transmit the acquired information of position, direction, etc. to the external detection device. One end of a wire 51 is connected with the detection component 5, and the other end of the wire 51 passes through the operating handle 4 to be connected with an external detection device. In this embodiment, as shown in fig. 4, the wire 51 is inserted into the wire channel 14 and is inserted out of the handle 4, so that the structure is more compact, and the redundancy of exposed wires is avoided. In other embodiments, the detection assembly 5 may also be wirelessly coupled to an extracorporeal detection apparatus.

Specifically, the detection assembly 5 and the external detection device in this embodiment are electromagnetic positioning systems of an energy delivery device, where the external detection device is an external magnetic field generating device. The system can acquire the moving position and the direction coordinates of one end of the guide tube 1 far away from the operating handle 4 in real time in an electromagnetic positioning system in the magnetic field space of the external magnetic field generating device through the detection assembly, and position the guide tube.

The present embodiment applies the steps of the energy delivery device described above: the guide tube 1 is controlled by the operation handle 4 to send the inflatable structure 2 and the energy delivery assembly 3 in the contracted state into a target area in the body, and the precise positioning is performed under the navigation of the detection assembly 5; feeding a cooling medium through a cooling medium channel 13 into the expandable structure 2 by means of a cooling medium source; when the expandable structure 2 expands, the flexible electrode 32 expands with the expandable structure 2 and uniformly abuts against the target area; controlling pulse energy release through an energy supply device to perform pulse treatment on a target area; in the process of the multi-pulse treatment, the expandable structure can be controlled by controlling the input and output of the cooling medium, and simultaneously, the heat generated by the treatment is absorbed and taken away; the time and number of pulse treatments are controlled and manipulated for different target area lesion types and different treatment protocols, as well as the magnitude of the pulse energy delivered.

The flexible electrode is net-shaped and coated on the surface of the expandable structure, and the structure is more compact, and the tensile property and the structural stability are higher. The joint area of the reticular flexible electrode and the target area is larger and more uniform, and the treatment effect is better. The guide pipe is a double-layer guide pipe and is provided with a cooling medium channel and a wire channel, so that the structure is compact, and the redundancy that wires are exposed is avoided. The energy delivery device of the present application can guide the expandable structure and the energy delivery assembly to precisely reach the target area through the positioning and navigation of the detection assembly.

The energy delivery device has the advantages of simple structure, simple operation steps, lower cost, convenient popularization and production and contribution to reducing the economic burden of patients.

While the foregoing description illustrates and describes the preferred embodiments of the present utility model, as noted above, it is to be understood that the utility model is not limited to the forms disclosed herein but is not to be construed as excluding other embodiments, and that various other combinations, modifications and environments are possible and may be made within the scope of the inventive concepts described herein, either by way of the foregoing teachings or by those of skill or knowledge of the relevant art. And that modifications and variations which do not depart from the spirit and scope of the utility model are intended to be within the scope of the appended claims.

Claims

1. The energy delivery device is characterized by comprising a guide tube (1), an expandable structure (2), an energy delivery assembly (3) and an operating handle (4), wherein one end of the guide tube (1) is connected with the operating handle (4), and the other end of the guide tube (1) is connected with the expandable structure (2);

a cooling medium channel is formed in the guide pipe (1), one end of the cooling medium channel (13) is used for being communicated with a cooling medium source, and the other end of the cooling medium channel (13) is communicated with the expandable structure (2);

the energy delivery assembly (3) comprises a conveying line (31) and a flexible electrode (32), one end of the conveying line (31) is connected with the flexible electrode (32), the other end of the conveying line (31) is used for being connected with an energy supply device, the flexible electrode (32) is in a net shape, and the flexible electrode (32) is coated on the expandable structure (2).

2. An energy delivery device according to claim 1, characterized in that the end of the guide tube (1) remote from the operating handle (4) is provided with a detection assembly (5).

3. An energy delivery device according to claim 1, characterized in that the guiding tube (1) comprises an outer layer tube (11) and an inner layer tube (12), a cooling medium channel (13) being formed between the outer layer tube (11) and the inner layer tube (12).

4. An energy delivery device according to claim 3, characterized in that one end of the expandable structure (2) close to the handle (4) is connected to the outer tube (11), and the other end of the expandable structure (2) is connected to the inner tube (12).

5. An energy delivery device according to claim 1, characterized in that the flexible electrode (32) is a quadrilateral mesh structure.

6. An energy delivery device according to claim 5, characterized in that the flexible electrode (32) is cut, woven or electroformed.

7. An energy delivery device according to claim 6, characterized in that the two ends of the flexible electrode (32) are connected to the two ends of the expandable structure (2) by means of connectors (321), respectively.

8. An energy delivery device according to claim 7, wherein the flexible electrode (32) is expandable with expansion of the expandable structure (2) and contractible with contraction of the expandable structure (2).

9. An energy delivery device according to claim 1, characterized in that the lever (4) is provided with a communication part (41), the communication part (41) communicating with the cooling medium source and the cooling medium channel (13), respectively.

10. An energy delivery device according to claim 2, wherein the detection assembly (5) is in communication with an extracorporeal detection device.