CN114469276A - Visual puncture cryoablation system - Google Patents

Abstract

A visual puncture cryoablation system comprises a freezing medium supply device, a functional body and an imaging illumination device, wherein the functional body is connected with the freezing medium supply device and has the functions of puncturing and cryoablation of tissues, the imaging illumination device illuminates and images in the process that the functional body punctures and treats the tissues and conducts the images or video signals back to an external display system in real time to assist in puncturing and cryoablation, the imaging illumination device is partially or completely positioned in the functional body, and an injection cavity is further arranged inside the functional body and is open to the tissues. Compared with the prior art, the visual puncture cryoablation system realizes visualization in the whole process of puncture, diagnosis and treatment, accurately finishes the purpose of treatment in the shortest time and with the smallest trauma, and reduces the pain of patients.

Description

Visual puncture cryoablation system

Technical Field

The invention relates to medical equipment, in particular to a visual puncture cryoablation system.

Background

At present, in minimally invasive surgery, the basic surgical procedure using a conventional cryoablation needle is as follows: the cryoablation needle is guided by ultrasound or X-ray to insert the needle body into the human body, and then a low-temperature medium is input for treatment. In the above-described procedure, when puncturing is performed with a puncture needle, it is generally performed under an indirect image by an auxiliary guide such as an ultrasonic probe or X-ray. However, due to the indirect image observation feature, it is difficult for the operator to accurately puncture the target site at one time. Thus, multiple punctures may be required, resulting in increased trauma, delayed recovery, and possibly even infection. In addition, the traditional cryoablation needle cannot directly view a puncture path due to no visual function, so that tissue or blood vessel damage is often caused, and pain is brought to a patient. Meanwhile, real-time monitoring of the treatment process and treatment condition evaluation cannot be realized.

Disclosure of Invention

The invention aims to provide a visual puncture cryoablation system, which realizes the whole process of visualization in the process of puncture, diagnosis and treatment, completes the treatment in the shortest time and with the smallest trauma and reduces the pain of patients.

Specifically, the above technical problem is solved by the following embodiments:

1. a visual puncture cryoablation system comprises a freezing medium supply device, a functional body and an imaging illumination device, wherein the functional body is connected with the freezing medium supply device and has the functions of puncturing and cryoablation of tissues, the imaging illumination device illuminates and images in the process that the functional body punctures and treats the tissues and conducts the images or video signals back to an external display system in real time to assist in puncturing and cryoablation, the imaging illumination device is partially or completely positioned in the functional body, and an injection cavity is further arranged inside the functional body and is open to the tissues.

2. The system of embodiment 1, wherein the functional body further comprises a freezing medium access passage inside, and the freezing medium access passage is closed by an internal circulation.

3. The visual puncture cryoablation system of any of embodiments 1-2, wherein the functional body comprises a puncture needle, a needle head at a distal end of the puncture needle, and a needle cannula connected to the needle head, and the imaging illumination device is disposed in the needle cannula.

4. The visual puncture cryoablation system of embodiment 3 wherein the proximal needle end of the imaging illumination device is juxtaposed with or contained within the infusion lumen, preferably wherein the proximal needle end of the imaging illumination device is contained within the infusion lumen.

5. The system of embodiment 4, wherein the injection cavity comprises an injection passage located inside the needle tube, an injection port located at the distal end of the needle and inside the needle tube and communicating with the outside, and an outlet port opening at the proximal end of the needle, the freezing medium inlet and outlet passage comprises a freezing medium inlet and a freezing medium recovery port located at one side away from the needle, and an inlet and outlet freezing medium circuit extending along the length direction of the needle, and one side of the needle tube facing the needle is at least partially a temperature conducting portion associated with the inlet and outlet freezing medium circuit.

6. The system of any of embodiments 1-5, wherein the imaging illumination device comprises a lens and an illumination device, preferably the lens is an optical lens or an electronic lens, preferably the illumination device is disposed partially or completely around the lens.

7. The visual puncture cryoablation system of embodiment 6 wherein said lens is adjustable in position either longitudinally or laterally as viewed.

8. The visual puncture cryoablation system of embodiments 6 or 7 wherein the visual puncture cryoablation system further comprises an illumination source disposed at the needle end or the distal needle end, the distal needle end light source being illuminated by the light transmission assembly to the needle end.

9. The system of embodiment 8 wherein the functional body further comprises a handle disposed on a side of the needle cannula distal from the needle, the light source is disposed within the handle, and the light source and the handle are integrally formed.

10. The system of embodiment 9, wherein the system further comprises an adapter electrically connected to the lens and the light source, the adapter having an image conducting connector thereon, the adapter being fixed relative to the handle.

11. The system according to any of embodiments 5-10, wherein the objects that can be injected into the injection cavity through the injection port include medical fluids or other fluids needed for diagnosis and treatment of body tissues, or other instruments needed for surgery, such as laser fibers, guide wires, biopsy forceps, baskets, etc.

12. The system of any of embodiments 5-10, wherein the freezing medium entering and exiting the freezing medium access passage is liquid nitrogen or other surgically acceptable refrigerant.

13. The visual puncture cryoablation system of any of embodiments 1-12 wherein said visual puncture cryoablation system further comprises a temperature control device for monitoring, displaying and controlling the temperature of the functional body.

14. The system of any of embodiments 1-12, wherein the system further comprises an insulating and thermal barrier layer.

15. The visual puncture cryoablation system of embodiment 14 wherein the insulative layer is disposed outside the needle such that the needle is in an enclosure of the insulative layer.

16. The system of embodiment 15 wherein the insulative layer is graduated for monitoring the depth of penetration.

17. The visual puncture cryoablation system of embodiment 16 wherein the graduations are disposed on the needle cannula.

In one embodiment, a visual puncture cryoablation system is provided, comprising:

the functional body is provided with a puncture needle, and the puncture needle is provided with a needle head positioned at the far end of the puncture needle and a needle tube connected with the needle head; and the number of the first and second groups,

an imaging illumination device disposed in the needle cannula and operable to illuminate and photograph through the distal end of the puncture needle;

a freezing medium injection port and a freezing medium recovery port are formed in one side, away from the needle head, of the functional body, a freezing medium inlet and outlet loop extending along the length direction of the puncture needle is formed in the puncture needle, and one side, away from the needle head, of the freezing medium inlet and outlet loop is communicated with the freezing medium injection port and the freezing medium recovery port; and one side of the needle tube facing the needle head is at least partially the temperature conduction part associated with the inlet and outlet freezing medium circuit;

the needle tube is also provided with an injection port, and an injection channel communicated with the injection port is also arranged in the puncture needle; and the object injection channel extends towards the direction of the needle head and extends to penetrate through the puncture needle and is not communicated with the in-out freezing medium loop.

In one embodiment, a containing cavity for containing the imaging illumination device is formed in the needle tube, and the distal end of the puncture needle is provided with an opening of the containing cavity.

In one embodiment, the opening of the accommodating cavity is formed on the needle head; or the opening of the containing cavity is arranged on the needle tube.

In one embodiment, the accommodating cavity extends along the length direction of the puncture needle, and a gap between the imaging illumination device and the cavity wall of the accommodating cavity is used as the injection channel.

In one embodiment, the needle tube has an outer tube, a first inner tube sleeved in the outer tube, and the first inner tube has the accommodating cavity therein; the opening of the first inner tube facing the needle head is an opening of the accommodating cavity;

wherein the inlet and outlet refrigerant medium circuit is located between the first inner tube and the outer tube.

In one embodiment, the refrigerant inlet and outlet circuit is provided with a liquid inlet channel communicated with the refrigerant inlet and extending along the length direction of the puncture needle, and a liquid outlet channel communicated with the refrigerant recovery port and extending along the length direction of the puncture needle, and the liquid inlet channel is communicated with the liquid outlet channel; wherein the liquid inlet channel, the liquid outlet channel and the opening of the needle head are not communicated.

In one embodiment, the first inner tube is connected to the outer tube around the opening to the needle by a seal.

In one embodiment, the liquid outlet channel is arranged around the periphery of the accommodating cavity.

In one embodiment, the puncture needle has a second inner tube disposed between the outer tube and the first inner tube, and an end of the second inner tube facing the needle head is spaced from the sealing element; and the second inner pipe and the first inner pipe are separated to form a liquid outlet channel.

In one embodiment, a liquid inlet pipe communicated with the freezing medium inlet is inserted into the liquid outlet channel, the liquid inlet channel is arranged in the liquid inlet pipe, and the liquid inlet pipe is separated from the side wall of the liquid outlet channel.

In one embodiment, the second inner tube is separated from the outer tube to form a separation cavity, and one end of the separation cavity facing the needle head is a closed end; wherein the area where the closed end of the compartment is spaced from the seal forms part of the in-and-out refrigerant medium circuit.

In one embodiment, the liquid inlet channel is arranged around the periphery of the accommodating cavity.

In one embodiment, a second inner tube is arranged in the puncture needle and sleeved between the outer tube and the first inner tube, and the second inner tube and the outer tube and the first inner tube are separated from each other to form two communicated liquid passing areas; one of the two liquid feeding areas is the liquid inlet channel, and the other is the liquid outlet channel.

In one embodiment, the end of the second inner tube facing the needle is spaced from the sealing element, and both ends of the two liquid-carrying areas facing the needle are open ends.

In one embodiment, the functional body is connected with an injection pipe connected into the liquid inlet channel, and the freezing medium injection port is formed in the injection pipe;

the functional body is connected with a recovery pipe connected with the liquid outlet channel, and the freezing medium recovery port is arranged on the recovery pipe.

In one embodiment, the imaging and illuminating device is provided with a lens and a light guide fiber, and one end of the lens and/or the light guide fiber is/are operably arranged at the opening of the accommodating cavity.

In one embodiment, the imaging illumination device is fixedly arranged in the functional body.

In one embodiment, the system further comprises a light source connected to the optical fiber.

In an embodiment, the functional body further has a handle disposed on a side of the needle tube away from the needle, the light source is disposed in the handle, and the light source and the handle are integrated.

In one embodiment, the system further comprises an adapter electrically connected to the lens and the light source, the adapter having an image conducting connector thereon, the adapter being fixed relative to the handle.

In one embodiment, the visual puncture cryoablation system further comprises an adapter connected to the imaging illumination device, the adapter having an image conducting connector and a light source coupling connector for externally connecting a light source.

In one embodiment, the imaging illumination device is movably disposed within the needle cannula along the length of the needle.

In one embodiment, the visual puncture cryoablation system further comprises a light source converter connected to the light guide fiber, and the light source converter is movably connected to the functional body.

In one embodiment, the functional body further comprises a handle arranged on the side of the needle tube far away from the needle head, and the light source converter is arranged outside the handle and connected with the handle through a length shifter.

In an embodiment, the visual puncture cryoablation system further comprises an adapter electrically connected to the light source converter; the adapter has image conductive contacts thereon.

In one embodiment, the visual puncture cryoablation system further comprises an adapter electrically connected with the imaging illumination device, the adapter is provided with an image conduction connector and a light source coupling connector, the light source coupling connector is used for externally connecting a light source, and the adapter is connected with the functional body through a length shifter.

In one embodiment, the lens is an optical lens or an electronic lens.

In one embodiment, the functional body further comprises an insulating layer arranged outside the needle tube, and one end of the insulating layer facing the needle head is separated from the needle head; the part of the needle tube between the needle head and one end of the insulating layer facing the needle head is exposed outside, and the exposed part of the needle tube forms the temperature conduction part.

In one embodiment, the insulating layer is further provided with scales.

In one embodiment, the visual puncture cryoablation system further comprises: and the temperature detection device is arranged on the functional body.

In one embodiment, the temperature detecting device has a pair of temperature measuring wires connected to the second inner tube, and the second inner tube has a pair of spaced apart wire contacts, and the pair of temperature measuring wires are respectively connected to the pair of wire contacts.

In one embodiment, the temperature detecting device has a pair of temperature measuring wires connected to each other, and the outer tube or the first inner tube has a pair of spaced apart wire contacts connected to the pair of temperature measuring wires.

Compared with the prior art, the embodiment of the invention has the advantages that the imaging and illuminating device is arranged and can illuminate and shoot through the far end of the puncture needle, when the puncture needle punctures, the cavity wall of the liquid expandable tissue is injected into the injection channel through the injection port, and the interferent around the needle head is cleaned, so that the imaging and illuminating device can clearly shoot the situation around the needle head, and the puncture needle can be accurately positioned to a focus. The refrigerant can be injected into the in-out freezing medium loop through the in-out freezing medium loop, the temperature of the refrigerant is conducted to the focus through the temperature conduction part and the needle head on the needle tube, and the focus is removed after the focus is frozen. In the treatment process, the imaging and illuminating device monitors the lesion removal condition in a real-time direct-view manner, and the purpose of treatment is achieved in the shortest time and with the smallest wound, so that the patient can be treated more safely and efficiently, and the pain of the patient is reduced.

Drawings

One or more embodiments are illustrated by way of example in the accompanying drawings, which correspond to the figures in which like reference numerals refer to similar elements and which are not to scale unless otherwise specified.

FIG. 1 is a schematic structural view of a visual puncture cryoablation system in accordance with a first embodiment of the present invention;

FIG. 2 is an enlarged partial view of the distal end of the visual puncture cryoablation system in accordance with the first embodiment of the present invention;

FIG. 3 is a cross-sectional view of FIG. 2;

FIG. 4 is a schematic view of a connection structure of a lens and a light guide fiber of an imaging and lighting device according to a first embodiment of the present invention;

FIG. 5 is a cross-sectional view of the handle area of a visual puncture cryoablation system in accordance with a first embodiment of the present invention;

FIG. 6 is a schematic structural view of another visual puncture cryoablation system in accordance with a first embodiment of the present invention;

FIG. 7 is a cross-sectional view of the handle area of another visual piercing cryoablation system in accordance with the first embodiment of the present invention;

FIG. 8 is a schematic illustration of a visual puncture cryoablation system in use according to a first embodiment of the present invention;

FIG. 9 is a cross-sectional view of the distal end of a visual puncture cryoablation system in accordance with a second embodiment of the present invention;

FIG. 10 is a cross-sectional view of the handle area of a visual puncture cryoablation system in accordance with a second embodiment of the present invention;

FIG. 11 is a schematic structural view of a visual puncture cryoablation system in accordance with a third embodiment of the present invention;

FIG. 12 is an exploded view of a visual puncture cryoablation system in accordance with a third embodiment of the present invention;

FIG. 13 is a cross-sectional view of a light source converter according to a third embodiment of the present invention;

FIG. 14 is a schematic structural view of another visual puncture cryoablation system in accordance with a third embodiment of the present invention;

FIG. 15 is a cross-sectional view of the handle area of a visual puncture cryoablation system in accordance with a fourth embodiment of the present invention;

FIG. 16 is a cross-sectional view of the distal end of the visual penetrating cryoablation system of FIG. 15;

FIG. 17 is a cross-sectional view of the handle region of another visual puncture cryoablation system in accordance with a fourth embodiment of the present invention;

FIG. 18 is a cross-sectional view of the distal end of the visible penetrating cryoablation system of FIG. 17;

fig. 19 is a schematic view of a visual puncture cryoablation system in accordance with a fourth embodiment of the present invention.

Fig. 20 is a block diagram of the evolution of a conventional cryoablation system to the visual puncture cryoablation system of the present invention.

Fig. 21 is a schematic view of a contoured visual penetrating cryoablation system of the present invention.

Fig. 22 is an ultrasonic image (fig. 22A) and a direct-view image (fig. 22B) obtained when the visual puncture cryoablation system of the present invention performs a puncture experiment on an ex vivo pig kidney, wherein an arrow indicates a needle body position.

Fig. 23 is an ultrasound image obtained from a puncture experiment of an ex vivo pig kidney under ultrasound guidance using a conventional cryoablation needle, where the arrow indicates the needle body position.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it will be appreciated by those of ordinary skill in the art that numerous technical details are set forth in order to provide a better understanding of the present application in various embodiments of the present invention. However, the technical solution claimed in the present application can be implemented without these technical details and various changes and modifications based on the following embodiments.

In the following description, for the purposes of illustrating various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. One skilled in the relevant art will recognize, however, that the embodiments may be practiced without one or more of the specific details. In other instances, well-known devices, structures and techniques associated with this application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

Throughout the specification and claims, the word "comprise" and variations thereof, such as "comprises" and "comprising," are to be understood as an open, inclusive meaning, i.e., as being interpreted to mean "including, but not limited to," unless the context requires otherwise.

The embodiments of the present invention will be described in detail below with reference to the accompanying drawings in order to more clearly understand the objects, features and advantages of the present invention. It should be understood that the embodiments shown in the drawings are not intended to limit the scope of the present invention, but are merely intended to illustrate the spirit of the technical solution of the present invention.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that the term "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

In the following description, for the purposes of clearly illustrating the structure and operation of the present invention, directional terms will be used, but terms such as "front", "rear", "left", "right", "outer", "inner", "outer", "inward", "upper", "lower", etc. should be construed as words of convenience and should not be construed as limiting terms.

Compared with the conventional cryoablation system, the visual puncture cryoablation system can image tissues (such as nerves, blood vessels, tendons and the like) around the functional body through the imaging and illuminating device positioned in the functional body when the puncture and ablation functions of the functional body are performed, and transmit the images or video signals back to the external display system in real time to assist in puncture and cryoablation.

As used herein, a "functional body" is the portion of a visual penetrating cryoablation system that performs penetrating, cryoablation on tissue. The functional body and the imaging and lighting device can be in a whole or not, and together form the executive body. The effector thus has the function of performing puncture, cryoablation and imaging illumination of the tissue.

The "infusion lumen" is a cavity inside the functional body, through which not only can a medical solution or other liquids needed by body tissues in diagnosis and treatment, such as physiological saline and the like, be infused from the outside, but also other instruments needed by surgery, such as laser fibers, guide wires, biopsy forceps, baskets and the like, can be placed into the infusion lumen and reach a target tissue site. Thus, when the needle tip of the functional body reaches the target tissue site, a liquid (such as physiological saline) can be injected to wash the target tissue site for clear imaging, or a medicine can be applied to the target tissue site or biopsy sampling treatment can be performed. The proximal needle end of the imaging illumination device is juxtaposed (separated) from the injection cavity or the proximal needle end of the imaging illumination device is contained in the injection cavity, preferably the proximal needle end of the imaging illumination device is contained in the injection cavity.

The interior of the functional body also comprises a freezing medium access channel, and the freezing medium access channel is closed by internal circulation. The term "closed by internal circulation" means that the freezing medium access passage is not in communication with other cavities in the functional body, such as the injection cavity, so that the freezing medium, such as a refrigerant, e.g., liquid nitrogen, in the freezing medium access passage does not come into contact with the tissue.

The imaging illumination device comprises a lens and an illumination device which partially or completely surrounds the lens, and the lens can be an optical lens or an electronic lens.

Embodiments of the present invention are described below with reference to the drawings.

Fig. 20 is a block diagram of a conventional cryoablation system evolving into the visual puncture cryoablation system of the present invention. The cross-section of the functional body of a conventional cryoablation needle is shown as 20-1 (shown in phantom a). The inventor of the present application thinks that a cavity (B white portion) is provided in the functional body portion, and the remaining portion (a shaded portion) is used to perform the function of the conventional cryoablation needle (including puncturing, cryoablation, temperature control, insulation, etc.), an imaging illumination device (C black portion) can be placed in the cavity portion, and the remaining portion (B white portion) can be used as an injection cavity and a freezing medium access channel, and the freezing medium access channel can be partially or completely arranged in the a shaded portion and can be partially or completely arranged in the B white injection cavity space. Wherein the injection cavity and the freezing medium inlet and outlet channel are not communicated. The functional body of the present application can also be in other evolved special-shaped structures, such as an oval shape, a gourd-shaped structure, etc. (as shown in fig. 21, all the hatched parts of a in fig. 21, a, B, C, d represent the functional body, the white parts of B represent the injection cavity, and the black parts of C represent the imaging and lighting device). The evolution of the special-shaped structure is only used for illustration of the embodiment and does not limit the shapes and combination forms of the functional body, the imaging illumination device and the injection cavity of the visual puncture cryoablation system.

A first embodiment of the present invention and a visual puncture cryoablation system 100, as shown in fig. 1, 2, 3, 4, and 5, comprises: a functional body 1 and an imaging illumination device 12. The functional body 1 has a puncture needle 11, the puncture needle 11 having a needle tip 112 at a distal end thereof, and a needle tube 113 connected to the needle tip 112. An imaging illumination device 12 is disposed in the needle cannula 113 and is operable to illuminate and photograph through the distal end of the puncture needle 11. The functional body 1 is provided with a freezing medium inlet 151 and a freezing medium recovery port 161 at one side far away from the needle head 112, a freezing medium inlet and outlet circuit 65 extending along the length direction of the puncture needle 11 is arranged in the puncture needle 11, the freezing medium inlet and outlet circuit 65 extends to a position close to the needle head 112, one side of the freezing medium inlet and outlet circuit 65 far away from the needle head 112 is communicated with the freezing medium inlet 151 and the freezing medium recovery port 161, one side of the needle tube 113 facing the needle head 112 is at least partially a temperature conduction part 1130 associated with the freezing medium inlet and outlet circuit 65, the temperature conduction part 1130 is a working part which is in contact with a focus to freeze and remove the focus, other areas of the needle tube 113 are non-working areas, and the non-working areas do not conduct low-temperature freezing injury to body tissues. The needle tube 113 is further provided with an injection port 131, the puncture needle 11 is further provided with an injection channel 13 communicated with the injection port 131, and the injection channel 13 extends towards the needle head 112 and extends to the puncture needle 11, and is not communicated with the in-and-out freezing medium circuit 65.

Specifically, as shown in fig. 3 and 5, the arrow inside the puncture needle in fig. 3 is the flowing direction of the refrigerant, when the visual puncture cryoablation system is used, the puncture needle 11 is inserted into the human body, water flow is injected from the injection port 131, the injection channel 13 penetrates through the puncture needle 11, the water flow flows out from the puncture needle 11 and expands to the periphery, a cavity is formed at the periphery where the puncture needle 11 is located, and the imaging and illuminating device 12 can clearly shoot the specific position of the puncture needle 11, so that the peripheral tissue condition is shot. And the water flow can also wash the blood around the puncture needle 11, so that the imaging and illuminating device 12 can shoot clearly in the visual field. The injection port 131 can also be filled with medical liquid or other liquids required by body tissues during treatment, and other instruments required by operations, such as laser fibers, guide wires, biopsy forceps and other biopsy treatment instruments, can also be placed in the injection port. After the puncture needle 11 is in place, liquid nitrogen or other refrigerants usable in the operation are injected into the freezing medium injection port 151, the refrigerants flow into the freezing medium inlet and outlet circuit 65, the cold energy of the refrigerants is transmitted to the focus through the temperature conduction part 1130 and the needle head 112, and the focus is frozen and necrotized, so that the focus is removed. And the refrigerant flows back to the freezing medium recycling port 161 from the in-and-out freezing medium loop 65 and is discharged from the freezing medium recycling port 161, so that the temperature conduction part 1130 can continuously conduct low temperature to the focus to ensure the treatment effect, and the imaging and illuminating device 12 can continuously monitor the treatment process in a direct view, thereby reflecting the focus treatment condition. In actual use, the visual puncture cryoablation system is externally connected with a freezing medium circulating system, and the freezing medium circulating system enables the freezing medium to circulate in the inlet and outlet freezing medium loop 65.

As can be seen from the above, since the imaging and illuminating device 12 is provided, and the imaging and illuminating device 12 can illuminate and shoot through the distal end of the puncture needle 11, when the puncture needle 11 punctures, the cavity wall of the liquid expandable tissue is injected into the injection channel 13 through the injection port 131, and the interferent around the needle 112 is cleaned, so that the imaging and illuminating device 12 can clearly shoot the situation around the needle 112, and the puncture needle 11 can be accurately positioned to the focus. Refrigerant can be injected into the in-out freezing medium circuit 65 through the in-out freezing medium circuit 65, the temperature of the refrigerant is transmitted to the focus through the temperature transmission part 1130 on the needle tube 113 and the needle 112, and the focus is removed after being frozen. The imaging and illuminating device can be used for directly monitoring the focus removal condition in real time and finishing the treatment purpose in the shortest time and with the smallest wound, so that the patient can be treated more safely and efficiently, and the pain of the patient is reduced.

Implementation details of the present embodiment are specifically described below, and the following description is provided only for the sake of understanding and is not necessary for implementing the present embodiment.

Further, as shown in fig. 3 and 5, a cavity for accommodating the imaging illumination device 12 is formed in the needle tube 113, and the distal end of the puncture needle 11 is opened with an opening 140 of the cavity. The opening 140 may be formed at the needle tip 112, and the imaging illuminator 12 may photograph the periphery of the needle tip 112 of the puncture needle 11 through the opening 140. It will be appreciated that in other embodiments, the distal end of the needle 11 may also be transparent.

Preferably, as shown in FIG. 3, the opening 140 of the receiving cavity is formed in the needle 112, so that the imaging illumination device 12 can be photographed with a more precise orientation. And in other embodiments, the opening 140 of the receiving cavity may also be formed in the needle tube 113.

Further, as shown in fig. 3 and 5, the accommodating chamber extends along the length direction of the puncture needle 11, and a gap between the imaging illumination device 12 and the chamber wall of the accommodating chamber serves as an injection passage 13. The gap between the imaging illuminator 12 and the wall of the containment chamber may be formed by the imaging illuminator 12 being spaced from the wall of the containment chamber. The object injecting channel, namely the object injecting channel 13 is positioned in the accommodating cavity, and a new space structure object injecting channel 13 is not required to be opened up, so that the space in the puncture needle 11 is fully utilized, the diameter of the puncture needle 11 can be smaller, and the visual puncture cryoablation system can be more precise. It is understood that in other embodiments, the injection channel 13 may be disposed outside the accommodating cavity, and the injection port 131 of the injection channel 13 may or may not be in communication with the accommodating cavity.

In addition, as shown in fig. 3 and fig. 5, the needle tube 113 has an outer tube 1131 and a first inner tube 1132 sleeved inside the outer tube 1131, and the first inner tube 1132 has a receiving cavity therein, and an opening of the first inner tube 1132 facing the needle 112 is an opening 140 of the receiving cavity. Wherein the inlet and outlet refrigerant circuit 65 is located between the first inner tube 1132 and the outer tube 1131. Needle 112 may be connected to outer tube 1131 and also to first inner tube 1132, and needle 112 may be integrally formed with needle cannula 113.

Further, as shown in fig. 3 and 5, the arrow inside the puncture needle in fig. 3 indicates the flow direction of the refrigerant fluid, the inlet/outlet refrigerant circuit 65 has an inlet passage 15 communicating with the refrigerant inlet port 151 and extending in the longitudinal direction of the puncture needle 11, and an outlet passage 16 communicating with the refrigerant recovery port 161 and extending in the longitudinal direction of the puncture needle 11, and the inlet passage 15 communicates with the outlet passage 16. The liquid inlet channel 15 and the liquid outlet channel 16 are not communicated with the opening of the needle 112, and the refrigerant is discharged through the puncture needle 11 through the liquid inlet channel 15 and the liquid outlet channel 16.

Further, as shown in FIG. 3, the first inner tube 1132 is connected to the outer tube 1131 by a seal 1134 toward the periphery of the opening 140 of the needle 112. The sealing member 1134 is formed by bending and extending the tube body of the first inner tube 1132 to connect with the outer tube 1131. In some embodiments, the seal 1134, the first inner tube 1132, and the outer tube 1131 may be a unitary piece.

Alternatively, as shown in fig. 3, the liquid outlet channel 16 is arranged around the periphery of the accommodating cavity. In other embodiments, the liquid outlet channel can also be arranged without surrounding the accommodating cavity.

Further, as shown in fig. 3 and 5, the puncture needle 11 has a second inner tube 1133 disposed between the outer tube 1131 and the first inner tube 1132, the end of the second inner tube 1133 facing the needle 112 is spaced from the sealing member 1134, and the second inner tube 1133 is spaced from the first inner tube 1132 to form a liquid outlet channel 16.

Further, as shown in fig. 3 and 5, a liquid inlet pipe 150 communicating with the freezing medium inlet 151 is inserted into the liquid outlet passage 16, the liquid inlet passage 15 is provided in the liquid inlet pipe 150, and the liquid inlet pipe 150 is spaced apart from the side wall of the liquid outlet passage 16. When the visual puncture cryoablation system is used, the refrigerant flows into the liquid inlet pipe 150 from the freezing medium inlet port 151, flows out of the liquid inlet pipe 150 into the liquid outlet channel 16, and flows out of the liquid outlet channel 16.

Further, as shown in fig. 3 and 5, the second inner tube 1133 is spaced apart from the outer tube 1131 to form a compartment 1135, and the end of the compartment 1135 facing the needle 112 is closed. The area where the closed end of the compartment 1135 is separated from the seal 1134 forms part of the inlet and outlet refrigerant circuit 65, i.e. the refrigerant flows between the closed end of the compartment 1135 and the seal 1134 proximate to the outer tube 1131, the outer tube 1131 between the closed end of the compartment 1135 and the seal 1134 is the temperature conducting portion 1130 (working portion), so that the temperature conducting portion 1130 can receive the cold energy acting on the lesion. The separation cavity 1135 separates the liquid inlet pipe 150 and the liquid outlet passage 16 from the non-working part of the outer pipe 1131, so as to prevent the low temperature of the refrigerant from being transferred to the non-working part of the outer pipe 1131 to damage body tissue.

It is understood that in some embodiments, there may be no separation cavity 1135, and the second inner tube 1133 may directly attach to the outer tube 1131, or there may be no second inner tube 1133, and the first inner tube 1132 is separated from the outer tube 1131 to directly form the liquid outlet channel 16.

Further, as shown in fig. 2, fig. 3 and fig. 5, the functional body further includes an insulating layer 19 disposed outside the needle tube 113, and an end of the insulating layer 19 facing the needle 112 is spaced apart from the needle 112, a portion of the needle tube 113 between the needle 112 and the end of the insulating layer 19 facing the needle 112 is exposed, a temperature conducting portion 1130 is formed by the exposed portion of the needle tube 113, that is, a working portion of the outer tube 1131 is exposed, and a non-working portion of the outer tube 1131 is covered by the insulating layer 19.

Optionally, as shown in fig. 2, the insulating layer 19 may be an insulating sleeve that can be sleeved on the outer tube 1131, or a coating layer that can be coated on the outer tube 1131.

As shown in fig. 1 and 2, the insulating layer 19 is further provided with a scale 20. The depth of penetration of the puncture needle 11 can be seen by means of the scale 20.

Further, as shown in fig. 3 and 5, the functional body 1 is connected to an injection pipe 152 connected to the liquid inlet passage 15, and the refrigerant inlet 151 is opened in the injection pipe 152. The functional body 1 is connected to a recovery pipe 162 connected to the liquid outlet passage 16, and a refrigerant recovery port 161 is provided in the recovery pipe 162. A puncture injection tube 132 is further provided on the functional body 1, the puncture injection tube 132 is connected to the injection channel 13, and the injection port 131 is opened on the puncture injection tube 132. Specifically, the functional body 1 further includes a handle 18 connected to the puncture needle 11, the proximal end of the puncture needle 11 is inserted into the handle 18, and the injection tube 152, the recovery tube 162, and the puncture injection tube 132 are disposed on the handle 18. The refrigerant circulation system interfaces with the recovery pipe 162 and the injection pipe 152. It will be appreciated that the freezing medium inlet 151, the freezing medium recovery port 161, and the injection port 131 may be formed directly in the needle tube 113 or in the handle 18.

In addition, as shown in fig. 3 and 4, the imaging illumination device 12 has a lens 121 and a light guide fiber 122. The lens 121 may be an electronic lens 121, such as a CMOS/CCD lens 121, and the lens 121 may also be an optical lens 121.

Further, as shown in fig. 1, the imaging illumination device 12 is fixedly connected to the functional body 1.

In addition, as shown in fig. 3, the lens 121 and one end of the light guide fiber 122 are disposed at the opening 140 of the receiving chamber. In other embodiments, one of the lens 121 and the optical fiber 122 may be at the opening, and the other one is in the accommodating cavity and is at a distance from the opening 140 of the accommodating cavity, but the optical fiber 122 may also polish the lens 121.

Preferably, as shown in fig. 3, the light guide fiber 122 is disposed around the lens 121. It is understood that in other embodiments, the light guide fiber 122 may be located in a partial region of the sidewall of the lens 121.

Further, as shown in fig. 4, the imaging illumination device 12 is fixedly provided in the functional body 1.

Further, the visual puncture cryoablation system also has a light source 50 connected to the optical fiber 122, and the light source 50 may be a different light source such as an LED lamp.

Further, as shown in fig. 4, the functional body 1 further has a handle 18 disposed on a side of the needle tube 113 away from the needle 112, the light source 50 is disposed in the handle 18, and the light source 50 and the handle 18 are a single piece. The optical fiber 122 may be affixed to the handle 18, with the optical fiber 122 extending proximally of the functional body to be connected to the light source 50. As shown in fig. 5, a cable 123 is connected to the lens 121 and extends out of the handle 18. It is understood that in other embodiments, the light source 50 may be disposed outside the handle 18, the light source 50 is mounted in a light source converter fixed to the handle 18, and the light guide fiber 122 is connected to the light source, in which case the imaging and illuminating device 12 is also fixed in the accommodating cavity and immovable, and the imaging and illuminating device 12, the light source 50 and the functional body form a single piece.

Further, as shown in fig. 1, the visible puncture cryoablation system further comprises an adapter 17 electrically connected to the lens 121 and the light source 50, the adapter 17 having an image conducting connector 171 thereon, the adapter 17 being fixed relative to the handle 18. The image conduction connector 171 is externally connected with a camera, and the camera is connected with an endoscope monitor.

Specifically, as shown in fig. 1, an extension cable 170 is connected to the adapter 17, and one end of the extension cable 170 is connected to the connector interface 181 of the handle 18, and can be screwed or fastened to the handle 18 through a connector. The light source 50 and the lens 121 are electrically connected to the extension cable 170. That is, the light source 50, the imaging illumination device 12, and the functional body 1 form an integral piece, and the distance between the imaging illumination device 12 and the opening 140 of the housing cavity is not adjustable. Wherein the adapter 17 is detachable from the functional body 1, and after the visual puncture cryoablation system is used, the adapter 17 is detached for other functional bodies. Of course, the adapter 17 can also be integrated with the functional body, and after the visual puncture cryoablation system is used, the adapter 17 is disposed of together with the functional body 1.

It is appreciated that in other embodiments, there may be no light source 50 in the visual puncture cryoablation system 200, which has an adapter 27 that is different from the adapter 17 of the visual puncture cryoablation system that has a light source 50. Specifically, as shown in fig. 6 and 7, in the visible puncture cryoablation system 200 without light source, the adapter 27 connected to the functional body 1 has an external camera connected to the image conducting connector 271 and the light source coupling connector 272, the camera is connected to the endoscope monitor, and can observe the image captured by the lens 121, and the light source coupling connector 272 is connected to the external light source to allow the light of the light guide fiber 122 to be emitted. The adapter 27 is connected to the functional body 1 by an extension cable 170, which is the same structure as the visual puncture cryoablation system with a light source.

Taking the application of the visual puncture cryoablation system 100 as an example, as shown in fig. 8, when the visual puncture cryoablation system 100 is used, the ultrasonic monitoring device 101 indirectly displays the path along which the ablation device needs to walk outside the human body, the freezing medium injection port 151 and the freezing medium recovery port 161 are connected to the freezing medium circulation system 102, the injection port 131 is connected to the injector 103, and the image conducting connector 171 is connected to the camera monitoring device 104 to display the position of the needle 112. The applicator 1 is inserted into the tissue 105, the needle 112 is inserted over the lesion 106, and the temperature conductor 1130 on the needle 113 also works within the lesion for the area to be removed. It should be understood that in different embodiments of the visual puncture cryoablation system, the external components of the visual puncture cryoablation system may be changed accordingly, depending on the configuration of the visual puncture cryoablation system. In addition, the ultrasonic monitoring apparatus 101 may be replaced with another monitoring apparatus such as an X-ray apparatus.

A second embodiment of the present invention is directed to a visual puncture cryoablation system. The second embodiment is substantially the same as the first embodiment, with the main differences being: in the first embodiment, as shown in fig. 3, the liquid inlet passage 15 is provided in the liquid inlet pipe 150, and the liquid inlet pipe 150 is inserted in the liquid outlet passage 16. In the second embodiment of the present invention, as shown in fig. 9 and 10, the liquid inlet passage 15 is provided around the outer periphery of the accommodating chamber, that is, the liquid inlet passage 15 is provided around the outer periphery of the liquid inlet passage 13.

Further, as shown in fig. 9 and 10, a second inner tube 1133 is provided in the puncture needle 11 and is disposed between the outer tube 1131 and the first inner tube 1132, and the second inner tube 1133 is separated from the outer tube 1131 and the first inner tube 1132 to form two liquid passing areas 35 and 36, where one of the two liquid passing areas 35 and 36 is a liquid inlet channel and the other is a liquid outlet channel. As shown in fig. 9, the recovery pipe 162 is inserted into the liquid-feeding region 36, the liquid-feeding region 36 is a liquid outlet channel, the injection pipe 152 is inserted into the liquid-feeding region 35, the liquid-feeding region 35 is a liquid inlet channel, and the arrows indicate the flow direction of the refrigerant. It will be appreciated that in other embodiments, the wicking zone 35 is a liquid outlet channel and the wicking zone 36 is a liquid inlet channel.

Since the first embodiment corresponds to the present embodiment, the present embodiment can be implemented in cooperation with the first embodiment. The related technical details mentioned in the first embodiment are still valid in this embodiment, and the technical effects that can be achieved in the first embodiment can also be achieved in this embodiment, and are not described here again in order to reduce repetition. Accordingly, the related-art details mentioned in the present embodiment can also be applied to the first embodiment.

In the present embodiment, as shown in fig. 11 and 12, an imaging illumination device 12 is movably disposed in the needle tube 113 along the length direction of the puncture needle 11. Thus, as can be seen in connection with fig. 9, the distance between the lens 121 and the optical fiber 122 and the opening 140 of the receiving cavity can be adjusted in the visual puncture cryoablation system 400.

Further, as shown in fig. 9, 11, 12 and 13, the visual puncture cryoablation system 400 further has a light source converter 45 connected to the light-guiding fiber 122, and the light source converter 45 is movably connected to the functional body 1. The light source converter 45 is provided with a light source 450, the light guide fiber 122 is connected to the light source 450, and the cable of the lens 121 is electrically connected with the cable 451 in the light source converter 45. That is, the light source converter 45 and the imaging illumination device 12 are connected to each other, and the light source converter 45 is pulled to move the imaging illumination device 12 in the longitudinal direction of the puncture needle 11.

Further, as shown in fig. 11 and 12, the functional body 1 further has a handle 18 disposed on the side of the needle tube 113 away from the needle 112, and the light source converter 45 is disposed outside the handle 18 and connected to the handle 18 through the length shifter 46. One end of the length shifter 46 is connected to the interface 181 of the handle 18, and can be screwed or clamped, the light source converter 45 is connected to the movable end of the length shifter 46, and the length shifter 46 is adjusted to a proper position by the locking screw 461 after the lens 121 and the light guide fiber 122 are adjusted.

In addition, as shown in fig. 11 and 12, the system 400 further includes an adapter 17 electrically connected to the light source converter 45, and the adapter has an image conducting connector 171 thereon. The adapter 17, the light source converter 45, and the imaging illumination device 12 are integrally connected to be movable in the longitudinal direction of the puncture needle.

It is understood that in other embodiments, as shown in fig. 14, there may be no light source in the visual puncture cryoablation system 500, and the cable and optical fiber 122 connected to the lens 121 in the switch 55, and the switch 55 for connecting the length to the device 46. The adapter 27 of the visual puncture cryoablation system 500 is different from the adapter 17 of the visual puncture cryoablation system with a light source. Specifically, the system 500 further includes an adapter 27 electrically connected to the imaging illumination device 12, the adapter 27 has an image conducting connector 271 and a light source coupling connector 272, and the adapter 27 is connected to the functional body 1 through the length shifter 47. The adapter 27 is the same as the adapter of the first embodiment of the lightless visible puncture cryoablation system configuration and will not be described further herein.

Since the first embodiment and the second embodiment correspond to the present embodiment, the present embodiment can be implemented in cooperation with the first embodiment and the second embodiment. The related technical details mentioned in the first embodiment and the second embodiment are still valid in this embodiment, and the technical effects that can be achieved in the first embodiment and the second embodiment can also be achieved in this embodiment, and are not described herein again in order to reduce repetition. Accordingly, the related-art details mentioned in the present embodiment can also be applied to the first embodiment, and the second embodiment.

A fourth embodiment of the present invention is directed to a visual puncture cryoablation system, further comprising: and a temperature detection device arranged on the functional body.

Further, fig. 15 and 16 are sectional views of the handle and the distal end of a visual puncture cryoablation system respectively showing the mounting structure of the temperature detection device in the functional body, and fig. 17 and 18 are sectional views of the handle and the distal end of another visual puncture cryoablation system respectively showing the mounting structure of the temperature detection device in the functional body. The temperature detection device is provided with a pair of temperature measurement leads 143 and 144 connected to the second inner tube 1133, the second inner tube 1133 is provided with a lead connection point 145 and 146, the pair of temperature measurement leads 143 and 144 are respectively connected with the pair of lead connection points 145 and 146, the lead connection point 146 at the far end of the first inner tube 1132 is connected with the temperature measurement lead 144, the lead connection point 145 at the near end of the second inner tube 1133 is connected with the temperature measurement lead 143 to form a closed loop, in the operation of the visual puncture cryoablation system, the temperature of the second inner tube 1133 is influenced to change, and when temperature difference exists between the temperature measurement lead and the second inner tube 1133, electromotive force is formed between the temperature measurement lead and the temperature measurement lead, so that current is formed in the loop, for example, in fig. 19, the current is led out to the refrigerant medium circulation system 102 through the leads to complete electric signal transmission, thereby realizing temperature regulation and control. In addition, in various embodiments, the wire connection point for connecting a pair of temperature measuring wires can also be on the outer tube 1131 or the first inner tube.

In other embodiments, the temperature detecting device may have other structures, and the temperature detecting device has a sensor disposed on the outer tube, the sensor is directly connected to the end of the outer tube 1131 away from the needle, and the lead of the sensor is connected to the outside. The sensors may be disposed on different components of the functional body, such as the second inner tube or the first inner tube, on the visual puncture cryoablation system in different embodiments. The connecting structure of the temperature detection devices on the two visual puncture cryoablation systems is exemplified in the embodiment, and the temperature detection devices on the visual puncture cryoablation systems of other different embodiments can be arranged in the same way.

Experimental example 1

The in-vitro pig kidney is taken, and the cryoablation needle of the visual puncture cryoablation system is used for implementing a puncture experiment on the in-vitro pig kidney. The puncture process is through ultrasonic image (fig. 22A) judgement needle insertion direction, through the direct-view image (fig. 22B) real-time supervision puncture route of formation of image lighting device transmission and needle point surrounding tissue condition, when having tissue or blood interference direct-view image in the field of vision, through annotating the thing chamber and annotating the flush fluid, keep the field of vision clear to can realize whole journey visual.

Comparative example

The in vitro pig kidney is taken, a traditional cryoablation needle is used, a puncture experiment is carried out on the in vitro pig kidney under the guidance of ultrasound, and the puncture process can only depend on an ultrasound image (figure 23) to indirectly judge the needle inserting direction and path.

Comparing fig. 22 and 23, it can be seen that, compared with the method that only the ultrasonic image is used to indirectly judge the needle insertion direction and path, the cryoablation needle of the present invention can see the ultrasonic image and the direct-view image simultaneously when inserting the needle, which is helpful for understanding the condition of the internal fine tissue, thereby realizing more precise control of the needle insertion direction and path.

While the preferred embodiments of the present invention have been described in detail above, it should be understood that aspects of the embodiments can be modified, if necessary, to employ aspects, features and concepts of the various patents, applications and publications to provide yet further embodiments.

These and other changes can be made to the embodiments in light of the above detailed description. In general, in the claims, the terms used should not be construed to be limited to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled.

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.

The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (17)

1. A visual puncture cryoablation system comprises a freezing medium supply device, a functional body and an imaging illumination device, wherein the functional body is connected with the freezing medium supply device and has the functions of puncturing and cryoablation of tissues, the imaging illumination device illuminates and images in the process that the functional body punctures and treats the tissues and conducts the images or video signals back to an external display system in real time to assist in puncturing and cryoablation, the imaging illumination device is partially or completely positioned in the functional body, and an injection cavity is further arranged inside the functional body and is open to the tissues.

2. The visual puncture cryoablation system of claim 1 wherein said functional body interior further comprises a freezing medium access passage, said freezing medium access passage being closed by internal circulation.

3. The visual puncture cryoablation system of any one of claims 1-2 wherein the functional body comprises a puncture needle, a needle at a distal end of the puncture needle, and a needle cannula connected to the needle, the imaging illumination device being disposed in the needle cannula.

4. The visual puncture cryoablation system of claim 3, wherein the proximal needle end of the imaging illumination device is juxtaposed with or contained within the infusion chamber, preferably wherein the proximal needle end of the imaging illumination device is contained within the infusion chamber.

5. The visual puncture cryoablation system of claim 4, wherein the injection cavity comprises an injection passage located inside the needle tube, an injection port located at the distal end of the needle and inside the needle tube and communicating with the outside, and an exit port open at the proximal end of the needle, the freezing medium access passage comprises a freezing medium injection port and a freezing medium recovery port located at the side away from the needle, and an access freezing medium circuit extending along the length of the needle, and the side of the needle tube facing the needle is at least partially a temperature conducting portion associated with the access freezing medium circuit.

6. The system of any one of claims 1-5, wherein the imaging illumination device comprises a lens and an illumination device, preferably the lens is an optical lens or an electronic lens, preferably the illumination device is disposed partially or completely around the lens.

7. The visual puncture cryoablation system of claim 6 wherein said lens is adjustable in position either longitudinally or laterally as viewed.

8. The system of claim 6 or 7, wherein the system further comprises an illumination source disposed at the needle end or the distal needle end, the distal needle end light source being configured to transmit illumination to the needle end by the light conducting assembly.

9. The visual puncture cryoablation system of claim 8 wherein said functional body further comprises a handle disposed on a side of said needle cannula distal from said needle, said light source is disposed within said handle, and said light source is integral with said handle.

10. The system of claim 9, wherein the system further comprises an adapter electrically connected to the lens and the light source, the adapter having an image conducting connector thereon, the adapter being fixed relative to the handle.

11. The system of any of claims 5-10, wherein the objects that can be injected into the injection cavity through the injection port include medical fluids or other fluids needed for diagnosis and treatment of body tissues, or other instruments needed for surgery, such as laser fibers, guide wires, biopsy forceps, baskets, etc.

12. The system of any of claims 5-10, wherein the freezing medium entering and exiting the freezing medium access passage is liquid nitrogen or other surgically acceptable refrigerant.

13. The visual puncture cryoablation system of any one of claims 1-12 wherein said visual puncture cryoablation system further comprises a temperature control device for monitoring, displaying and controlling the temperature of the functional body.

14. The system of any of claims 1-12, wherein the system further comprises an insulating layer.

15. The visual puncture cryoablation system of claim 14 wherein the insulative layer is disposed outside the needle such that the needle is in the enclosure of the insulative layer.

16. The system of claim 15 wherein the insulative layer is graduated to monitor penetration depth.

17. The visual puncture cryoablation system of claim 16 wherein the graduations are disposed on the needle cannula.

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