阅读说明：本技术 支气管穿刺破壁装置 (Bronchus puncture wall breaking device ) 是由 黄景川 于 2019-10-17 设计创作，主要内容包括：本发明实施例提供的支气管穿刺破壁装置,包括外鞘管；导引头,头部呈尖锥状,尾部与所述外鞘管前端同轴紧固连接,所述导引头的内部中空并与所述外鞘管的内部连通形成一通道；穿刺针,用于同轴穿设于所述通道内,并能够在所述外鞘管内往复运动以从所述导引头的头部伸进或伸出。本发明提供的支气管穿刺破壁装置,能够穿透支气管壁,并能够对创口进行扩大、扩深,人为建立气管壁至目的病灶的路径,能够获取活检样本。(The bronchial puncture wall breaking device provided by the embodiment of the invention comprises an outer sheath tube; the head of the seeker is in a taper shape, the tail of the seeker is coaxially and fixedly connected with the front end of the outer sheath tube, the inside of the seeker is hollow, and the seeker is communicated with the inside of the outer sheath tube to form a channel; and the puncture needle is coaxially arranged in the channel in a penetrating way and can reciprocate in the outer sheath tube so as to extend into or out of the head part of the guide head. The bronchial puncture wall breaking device provided by the invention can penetrate the bronchial wall, can expand and deepen a wound, artificially establishes a path from the bronchial wall to a target focus, and can obtain a biopsy sample.)

1. A bronchial puncture broken wall device, its characterized in that includes:

an outer sheath tube;

the head of the seeker is in a taper shape, the tail of the seeker is coaxially and fixedly connected with the front end of the outer sheath tube, the inside of the seeker is hollow, and the seeker is communicated with the inside of the outer sheath tube to form a channel;

and the puncture needle is coaxially arranged in the channel in a penetrating way and can reciprocate in the outer sheath tube so as to extend into or out of the head part of the guide head.

2. The bronchial puncture wall-breaking device of claim 1, wherein the sheath comprises at least two sections of different hardness along a length of the sheath.

3. The bronchial puncture wall-breaking device of claim 1, wherein the outer sheath comprises an inner layer, a middle layer and an outer layer from inside to outside, the inner layer and the outer layer are organic material layers, and the middle layer is a woven layer.

4. The bronchial puncture wall-breaking device of claim 3, wherein at least one of the inner layer, the middle layer and the outer layer is mixed with a developing material.

5. The bronchial puncture wall-breaking device of claim 1, wherein a metal elastic tube is coaxially arranged in the outer sheath tube.

6. The bronchial puncture wall-breaking device of claim 1, wherein the tail of the guiding head is inserted into the front end of the sheath and fastened with the front end of the sheath.

7. The bronchial puncture wall-breaking device of claim 6, wherein an outer sidewall of the guide head is formed with a radially outwardly protruding escape-preventing portion to prevent the guide head from escaping from the outer sheath.

8. The bronchial puncture wall-breaking device of claim 7, wherein the slip-preventing part is spirally arranged on an outer side wall of the guide head;

or the falling-off prevention part is arranged on the outer side wall of the guide head in a barb shape, and the falling-off prevention part in the barb shape inclines from one end close to the outer sheath tube to one end far away from the outer sheath tube in the radial outward direction of the guide head.

9. The bronchial puncture wall-breaking device of claim 1, wherein the puncture needle front end shape comprises: any one of a tapered shape, a triangular shape, and a beveled shape.

10. A bronchial puncture wall-breaking device according to claim 1, wherein a magnetic navigation positioning sensor is provided in the guide head or in the sheath front end or in the puncture needle.

11. A bronchial puncture wall breaking device according to any one of claims 1-10, further comprising:

the operating handle comprises a first structural member and a second structural member, the first structural member is fixedly connected with the outer sheath tube, the second structural member is fixedly connected with the puncture needle, and the first structural member and the second structural member can move mutually.

12. A bronchial puncture wall breaking device according to claim 11,

the operating handle is provided with a mechanical interface, and the mechanical interface is used for connecting the negative pressure suction device.

13. A bronchial puncture wall breaking device according to claim 11,

the operating handle is provided with a locking device, and the locking device is used for locking the puncture needle, the guide head and the sheath tube relatively after the puncture needle extends out of the guide head by a preset length.

14. A bronchial puncture wall breaking device according to claim 11,

the operating handle is provided with an electrical interface which is used for electrically connecting a power supply surgical host.

Technical Field

The invention relates to medical equipment, in particular to a bronchial puncture wall breaking device.

Background

The diagnosis and treatment of pulmonary nodules has become increasingly important for the early discovery and treatment of lung cancer. The conventional pulmonary nodule biopsy method is to use percutaneous puncture method to insert a puncture needle directly into the lung to obtain biopsy samples, and the puncture method has the risk of pneumothorax. Studies have shown that percutaneous pulmonary puncture has a pneumothorax incidence of 20% -40%, which is a serious adverse reaction and can be fatal. Another safer way is to biopsy the pulmonary nodules through the natural airway with a bronchoscope, which can reduce the risk of adverse reactions, but this type is only applicable to pulmonary nodules with larger airways access.

Therefore, for pulmonary nodules without obvious tracheal access through a natural airway by a bronchoscope, a device which has strong puncture capability and can penetrate through the bronchial wall, enlarge and deepen a wound, artificially establish a path from the tracheal wall to a target lesion and enable the bronchoscope or other tools to reach the target lesion along the path for biopsy is urgently needed to be designed.

Disclosure of Invention

In view of the above, the present invention is proposed to solve the above problems or at least partially solve the above problems.

The embodiment of the invention provides a bronchial puncture wall breaking device, which comprises:

an outer sheath tube;

the head of the seeker is in a taper shape, the tail of the seeker is coaxially and fixedly connected with the front end of the outer sheath tube, the inside of the seeker is hollow, and the seeker is communicated with the inside of the outer sheath tube to form a channel;

and the puncture needle is coaxially arranged in the channel in a penetrating way and can reciprocate in the outer sheath tube so as to extend into or out of the head part of the guide head.

Further, the sheath comprises at least two sections with different hardness in the length direction of the sheath.

Further, the outer sheath tube comprises an inner layer, a middle layer and an outer layer from inside to outside, the inner layer and the outer layer are organic material layers, and the middle layer is a woven layer.

Further, at least one of the inner layer, the middle layer and the outer layer is mixed with a developing material.

Furthermore, a metal elastic tube coaxially penetrates through the outer sheath tube.

Furthermore, the tail part of the guide head is inserted into the front end of the outer sheath tube and is fastened with the front end of the outer sheath tube.

Further, the outer side wall of the guide head is formed with a radially outwardly protruding disengagement prevention portion to prevent the guide head from being disengaged from the outer sheath tube.

Further, the anti-falling part is spirally arranged on the outer side wall of the seeker;

or the falling-off prevention part is arranged on the outer side wall of the guide head in a barb shape, and the falling-off prevention part in the barb shape inclines from one end close to the outer sheath tube to one end far away from the outer sheath tube in the radial outward direction of the guide head.

Further, the shape of the puncture needle front end comprises: any one of a tapered shape, a triangular shape, and a beveled shape.

Furthermore, a magnetic navigation positioning sensor is arranged in the guide head or the front end of the sheath tube or the puncture needle.

Further, the method also comprises the following steps:

the operating handle comprises a first structural member and a second structural member, the first structural member is fixedly connected with the outer sheath tube, the second structural member is fixedly connected with the puncture needle, and the first structural member and the second structural member can move mutually.

Further, in the above-mentioned case,

the operating handle is provided with a mechanical interface, and the mechanical interface is used for connecting the negative pressure suction device.

Further, in the above-mentioned case,

the operating handle is provided with a locking device, and the locking device is used for locking the puncture needle, the guide head and the sheath tube relatively after the puncture needle extends out of the guide head by a preset length.

Further, in the above-mentioned case,

the operating handle is provided with an electrical interface which is used for electrically connecting a power supply surgical host.

The bronchus puncture wall-breaking device provided by the embodiment of the invention comprises an outer sheath tube, a guide head and a puncture needle, wherein the head part of the guide head is in a taper shape, the tail part of the guide head is coaxially and fixedly connected with the front end of the outer sheath tube, the inner part of the guide head is hollow and is communicated with the inner part of the outer sheath tube to form a channel, and the puncture needle is coaxially arranged in the channel in a penetrating way, can reciprocate in the outer sheath tube and extends into and out of the guide head. When the puncture wall-breaking device is used for surgery, the front end of the puncture wall-breaking device reaches a puncture starting point and faces a puncture target point, the sheath tube and the seeker are kept still, and the puncture needle is inserted forwards for a certain distance and then extends into the seeker. Then the puncture needle is fixed, the outer sheath tube is pushed forwards, the guide head is enabled to invade tissues along the direction of the puncture needle, a passage reaching a target position is expanded, and the wound is expanded and deepened, so that a path from the tracheal wall to a target focus is artificially established, and a biopsy sample can be obtained.

Drawings

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

Fig. 1 is a structural cross-sectional view of a bronchial puncture wall breaking device provided in an embodiment of the present invention;

fig. 2 is a cross-sectional view of the guide head and the sheath of the wall breaking device for bronchial puncture according to the embodiment of the present invention;

fig. 3 is a cross-sectional view of the bronchial puncture wall breaking device provided in the embodiment of the present invention with a puncture needle removed;

FIG. 4 is a schematic view of a structure of a guide head in the wall-mounted bronchial puncture device according to an embodiment of the present invention;

FIG. 5 is a schematic view of an alternative embodiment of the invention showing the construction of the guide head in the wall-mounted bronchial puncture device;

FIG. 6 is a schematic view of another embodiment of a guide head in the wall-mounted bronchial puncture apparatus according to the present invention;

FIG. 7 is a schematic view of a configuration of a piercing needle head in a bronchial puncture wall arrangement provided in an embodiment of the present invention;

FIG. 8 is a schematic view of another embodiment of a spike head in a bronchial puncture wall arrangement provided in accordance with the present invention;

FIG. 9 is a schematic view of another embodiment of a spike head in a bronchial puncture wall arrangement provided in accordance with the present invention;

FIG. 10 is a cross-sectional view of another embodiment of the wall breaking device for bronchial puncture;

FIG. 11 is a schematic view of the puncture needle of FIG. 10 shown extended into the introducer;

fig. 12 is a schematic view of the puncture needle of fig. 10 extended out of the introducer tip;

FIG. 13 is a sectional view of another embodiment of the wall breaking device for bronchial puncture;

FIG. 14 is a sectional view of another embodiment of the wall breaking device for bronchial puncture according to the present invention;

FIG. 15 is a first schematic view of a bronchial puncture wall breaking procedure;

FIG. 16 is a second schematic view of the bronchial puncture wall breaking procedure;

FIG. 17 is a third schematic view of the bronchial puncture wall-breaking procedure;

FIG. 18 is a fourth schematic view of a bronchial puncture wall breaking procedure;

FIG. 19 is a fifth schematic view of the bronchial puncture wall breaking procedure;

FIG. 20 is a sixth schematic view of a bronchial puncture wall breaking procedure;

fig. 21 is a seventh schematic view of the bronchial puncture wall breaking procedure;

fig. 22 is a schematic view eight of the bronchial puncture wall breaking procedure;

FIG. 23 is a flow chart of a puncture wall breaking device operating under magnetic navigation conditions;

FIG. 24 is a flow chart of a puncture wall breaking device operating in a non-magnetic field environment without a guiding catheter under a bronchoscope;

fig. 25 is a flow chart of the puncture wall breaking device for operation in a non-magnetic field environment with a guiding catheter under a bronchoscope.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the following description and in the claims, the terms "include" and "comprise" are used in an open-ended fashion, and thus should be interpreted to mean "include, but not limited to. "substantially" means within an acceptable error range, and a person skilled in the art can solve the technical problem within a certain error range to substantially achieve the technical effect.

Furthermore, the term "coupled" is intended to include any direct or indirect coupling. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices. The following description is of the preferred embodiment for carrying out the invention, and is made for the purpose of illustrating the general principles of the invention and not for the purpose of limiting the scope of the invention. The scope of the present invention is defined by the appended claims.

It should be understood that the term "and/or" as used herein is merely one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

Various embodiments or examples and features of various embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Fig. 1 is a structural cross-sectional view of a bronchial puncture wall breaking device provided in an embodiment of the present invention; fig. 2 is a cross-sectional view of the guide head and the sheath of the wall breaking device for bronchial puncture according to the embodiment of the present invention; fig. 3 is a cross-sectional view of the bronchial puncture wall breaking device provided in the embodiment of the present invention with a puncture needle removed; FIG. 4 is a schematic diagram of a structure of a guide head in a bronchial puncture wall device according to an embodiment of the present invention; referring to fig. 1 to 4, the wall breaking device for bronchial puncture provided in this embodiment includes: sheath tube 10, guide head 20 and puncture needle 30.

As shown in fig. 4, the head 21 of the guide head 20 is tapered to reduce the resistance to drilling into the tissue, the tail 22 of the guide head 20 is coaxially and tightly connected with the front end of the outer sheath tube 10, and the interior of the guide head 20 is hollow and is communicated with the interior of the outer sheath tube 10 to form a channel a. Further, the tail 22 of the guide head 20 can be inserted into the front end of the sheath tube 10 and fastened to the front end of the sheath tube 10. Specifically, the tail 22 of the seeker 20 may be cylindrical, with the diameter of the head 21 of the seeker 20 at the maximum diameter being greater than the diameter of the tail 22 of the seeker 20. Preferably, the diameter of the maximum diameter of the head 21 of the guide head 20 is greater than or equal to the outer diameter of the sheath 10 to control the insertion depth of the guide head 20 into the sheath 10, and the diameter of the tail 22 of the guide head 20 may be slightly smaller than or equal to the inner diameter of the sheath 10. As shown in fig. 1 and 2, the maximum diameter of the leading portion of the seeker 20 is equal to the outer diameter of the sheath 10, and the diameter of the trailing portion 22 of the seeker 20 is equal to the inner diameter of the sheath 10.

The puncture needle 30 is adapted to be coaxially inserted through the passage a and is capable of reciprocating within the sheath tube 10 to protrude into or out of the head of the introducer 20. The puncture needle 30 is used for puncturing bronchial walls and lung tissues, and the sheath tube 10 and the guide tip 20 are used for expanding and deepening a punctured wound.

The puncture needle 30 may be a solid needle or a hollow needle, or the entire section of the puncture needle 30 may include a solid section, a hollow section, and a spiral section, and may be formed by mixing and splicing the solid section, the hollow section, and the spiral section. The puncture needle 30 may be made of corrosion-resistant materials such as nickel-titanium alloy, stainless steel, platinum-iridium alloy, and similarly, the guide head 30 may also be made of: corrosion resistant materials such as platinum iridium alloy, gold, silver, tungsten, stainless steel, etc. to improve the service life of the guide tip 20 and the puncture needle 30, and to prevent the rusted puncture needle 20 or guide tip 20 from causing infection damage to the human body.

In this embodiment, the outer sheath tube 10 may preferably include an inner layer, a middle layer and an outer layer from inside to outside, wherein the inner layer and the outer layer are organic material layers, and the middle layer is a woven layer. The inner layer material and the outer layer material can be medical organic materials to ensure no harm to human tissues, and specifically, the inner layer material and the outer layer material can be, but are not limited to, the following materials: PP (Polypropylene), PE (Polyethylene), PEBAX (block polyetheramide resin), PA (nylon, Polyamide), PTFE (polytetrafluoroethylene). Specifically, any of the above-mentioned materials can be selected, and the materials are not limited to the above-mentioned materials.

The middle layer material may include, but is not limited to, the following: PI wire (polyimide), 304 stainless steel wire, PEEK wire (polyetheretherketone). The middle layer of the sheath tube 10 can ensure that the sheath tube 10 has certain flexibility and certain supporting strength. In the using process, the sheath tube 10 needs to drive the guide head 20 to drill forwards to enlarge and deepen the wound, the sheath tube 10 needs to rotate to drill forwards in the drilling process, through the layered structure design of the sheath tube 10, the inner layer and the outer layer are organic material layers, the inner layer is a braided layer, the rotation and/or movement of the sheath tube 10 are consistent before and after, and the sheath tube can be bent in a human body to a small extent. Specifically, the middle layer of the braided layer can make the two ends of the outer sheath 10 move consistently when the outer sheath 10 rotates, that is, when one end of the outer sheath 10 rotates, the shear stress generated during the rotation can be transmitted to the other end of the outer sheath 10, so that the two ends of the outer sheath 10 rotate together, and the outer sheath 10 can drive the guide head 20 to expand and deepen the wound.

Further, the outer sheath 10 may include at least two sections of different stiffness along the length of the outer sheath 10, thereby achieving different passability and bending control performance along the length of the outer sheath 10.

At least one of the inner layer, the middle layer and the outer layer of the outer sheath tube 10 is mixed with a developing material. Preferably, a developing material is mixed in each of the inner layer, the middle layer and the outer layer, for example, barium sulfate, tungsten powder and the like may be mixed, and the developing material is mixed in the outer sheath 10, so that the outer sheath 10 has better developing performance to facilitate observation thereof during the operation to determine the position and the direction thereof.

The wall breaking device for the bronchus puncture provided by the embodiment comprises an outer sheath tube, a guide head and a puncture needle, wherein the head of the guide head is in a taper shape, the tail of the guide head is coaxially and fixedly connected with the front end of the outer sheath tube, the inner part of the guide head is hollow and is communicated with the inner part of the outer sheath tube to form a channel, and the puncture needle is coaxially arranged in the channel in a penetrating manner, can reciprocate in the outer sheath tube and extends into and out of the guide head. When the puncture wall-breaking device is used for surgery, the front end of the puncture wall-breaking device reaches a puncture starting point and faces a puncture target point, the sheath tube and the guide head are kept still, and the puncture needle is inserted forwards for a certain distance and then taken out. Then the puncture needle is fixed, the outer sheath tube is pushed forwards, the guide head is enabled to invade tissues along the direction of the puncture needle, a passage reaching a target position is expanded, and the wound is expanded and deepened, so that a path from the tracheal wall to a target focus is artificially established, and a biopsy sample can be obtained.

In the above embodiment, as shown in fig. 3, further, a metal elastic tube 11 may be coaxially inserted into the outer sheath tube 10. Specifically, the spring tube or the metal wire may be inserted into the sheath tube 10 to serve as a reinforcing tube of the sheath tube 10, so that the sheath tube 10 can have a certain expansion in the cross-sectional direction of the tube diameter, thereby preventing the sheath tube 10 from deforming and affecting the use, and increasing the passing performance and the bending control performance.

FIG. 5 is a schematic view of an alternative embodiment of a guide head for use in a bronchial puncture wall device; FIG. 6 is a schematic view of another embodiment of a guide head for use in a bronchial puncture wall device; as shown in fig. 5 or 6, the outer sidewall of the guide tip 20 is formed with a radially outwardly protruding escape prevention portion 21 to prevent the guide tip 20 from escaping from the outer sheath 10. The slip-off prevention part 21 may be a convex structure uniformly arranged on the outer sidewall of the guide head 20 to provide resistance against the movement of the guide head 20 in the direction away from the sheath tube 10. Specifically, as shown in fig. 5, the slip-off preventing portion 21 may be spirally disposed on the outer sidewall of the guide head 20; alternatively, as shown in fig. 6, the slip-off preventing portion 21 is arranged on the outer side wall of the guiding head 20 in a barb shape, and the slip-off preventing portion 21 in the barb shape is inclined from the end close to the outer sheath tube 10 to the end far from the outer sheath tube 10 in the radial outward direction of the guiding head 20, so that the connection strength between the guiding head 20 and the outer sheath tube 10 can be enhanced, and the guiding head 20 is prevented from being separated from the outer sheath tube 10 during the use of the bronchial puncture wall breaking device, thereby influencing the surgical process and increasing the surgical risk.

FIG. 7 is a schematic view of a configuration of a piercing needle head in a bronchial puncture wall arrangement provided in accordance with an embodiment of the present invention; FIG. 8 is a schematic view of another embodiment of a spike head in a bronchial puncture wall arrangement provided in accordance with the present invention; FIG. 9 is a schematic view of another embodiment of a lancet head in a wall-mounted bronchial puncture device provided in accordance with the present invention; the puncture needle 30 may be a solid needle or a hollow needle, and the shape of the front end of the puncture needle 30 may include: a tapered shape (as shown in FIG. 7), a triangular shape (as shown in FIG. 8), or a chamfered shape (as shown in FIG. 9). Of course, the front end of the puncture needle 30 may be designed into other shapes by those skilled in the art according to the actual situation, and the present invention is not limited thereto.

A magnetic navigation positioning sensor is provided in the introducer 20 or in the front end of the outer sheath 10 or in the puncture needle. The actual position and the advancing direction of the puncture needle 30 can be determined through the positioning of the magnetic navigation positioning sensor, so that whether the puncture needle 30 is aligned with a puncture target point or not is judged, and the accuracy of the operation is improved. And, make bronchus puncture broken wall device itself obtain the function of location in magnetic navigation positioning system through magnetic navigation positioning sensor, replace the use of location pipe, can further reduce the operation and consume.

FIG. 10 is a sectional view of the bronchial puncture wall breaking device provided in another embodiment of the present invention; FIG. 11 is a schematic view of the puncture needle of FIG. 10 shown extended into the introducer; fig. 12 is a schematic view of the puncture needle of fig. 10 extended out of the introducer tip; as shown in fig. 10-12, the bronchial puncture wall breaking device may further include: the handle 40 is operated.

The operating handle 40 includes a first structural member 41 and a second structural member 42, the first structural member 41 can be fixedly connected with the outer sheath 10, the second structural member 42 can be fixedly connected with the puncture needle 30, and the first structural member 41 and the second structural member 42 can move relative to each other. The first structural member 41 is fixedly connected to the outer sheath 10 and can be held by an operator to push the outer sheath 10 and the guide tip 30 to move, and the second structural member 42 is fixedly connected to the puncture needle 30 and can be held by the operator to push the puncture needle 30 to move relative to the outer sheath 10, so that the puncture needle 30 extends into or out of the guide tip 30. As shown in fig. 11-12, the second structural member 42 is pushed so that the piercing needle 30 is transformed from a state in which it extends into the guide 30 shown in fig. 11 to a state in which it extends out of the guide 30 shown in fig. 12.

FIG. 13 is a sectional view of the bronchial puncture wall breaking device provided in accordance with another embodiment of the present invention; the operating handle 40 may be provided with a mechanical interface 43, and the mechanical interface 43 is used for connecting a negative pressure suction device. Specifically, as shown in fig. 13, the mechanical interface 43 may be located at the end of the second structural member 42, and the mechanical interface 43 in this embodiment may be a luer, which is a convenient and attachable device used in the medical industry, and which greatly simplifies the management of liquid and gaseous medical fluids. Such a fitting allows multiple compatible fluids to be managed using the same tubing, thereby reducing trauma to the patient. The operation operator can be connected with a suction device through the luer interface, and can suck and sample after puncturing into a target focus.

It should be noted that, in this embodiment, in the case where it is necessary to connect the aspiration device through a luer, the puncture needle 30 should be a hollow needle, and after reaching the target lesion, the aspiration device provides negative pressure to aspirate the sample through the hollow puncture needle. By utilizing the puncture wall breaking device as a suction biopsy tool, the use of other biopsy tools and operations can be reduced, and the clinical cost and the tedious operation can be reduced.

Optionally, the operating handle 40 may further include an extension adjusting means (not shown) for adjusting the extension of the puncture needle 30 from the guide tip 20 to a predetermined length. Specifically, a plurality of preset lengths may be set, for example, the protrusion length may be set to 5cm, 10cm, 15cm, etc., and the puncture needle 30 may be positioned by the protrusion adjusting means when protruding 5cm, 10cm, 15cm, etc.

Optionally, the operating handle 40 may further include a locking device (not shown) for locking the puncture needle 30 with respect to the introducer 20 and the sheath 10 after the puncture needle 30 is extended from the introducer 20 by a predetermined length. Specifically, the locking device may include a locking member and an engaging portion, the locking member may be disposed on one of the first structural member 41 and the second structural member 42, and the engaging member engaged with the locking member may be disposed on the other of the first structural member 41 and the second structural member 42, for example, the locking member may be moved/rotated/inserted into and engaged with the engaging portion, and moved/rotated/inserted into and disengaged from the engaging portion, so that the puncture needle 30 is locked at the predetermined protruding length after the first structural member 41 and the second structural member 42 are relatively locked.

Fig. 14 is a sectional view of another structure of the wall breaking device for bronchial puncture according to the embodiment of the present invention. As shown in fig. 14, the operating handle 40 may further have an electrical interface 44, and the electrical interface 44 is used for electrically connecting to a power supply of the surgical host. Specifically, one end of the cable 45 and the plug are inserted into the second structural member 42, and are electrically connected with the puncture needle 30 of the puncture wall-breaking device, and the other end of the cable is connected with the main electrosurgical unit. Because the puncture needle 30 and the guide head 20 are powered, the extending end of the puncture needle 30 and the guide head 20 can perform monopolar or bipolar ablation and blood coagulation treatment on the puncture wound. Directly melt and the blood coagulation is handled the wound through bronchus puncture broken wall device to reduce the injury that the puncture caused, reduce the use and the operation of other electrosurgery instruments, reduce clinical expense and loaded down with trivial details operation.

The method for using the wall breaking device for bronchial puncture provided in this embodiment will be described in detail below. In particular to a process and a method for puncturing and wall breaking by a puncturing and wall breaking device under the magnetic navigation condition. Fig. 23 is a flow chart of the puncture wall breaking device for performing puncture wall breaking under magnetic navigation conditions. As shown in fig. 23:

s100: CT images were imported and a three-dimensional model of the pulmonary bronchial tree structure (as shown in fig. 15) and a three-dimensional model of the pulmonary vessels (arteries and veins) were reconstructed.

In step 100, the pulmonary bronchi and pulmonary vessels need to use different thresholds, respectively, in order to be separated from other tissues. The reconstructed bronchus and blood vessel models need to be superposed in the same three-dimensional model for observation (different color regions can be adopted for the bronchus and blood vessel models).

S200, a position range to be reached (i.e., a lesion position range) is outlined and one of the points is selected as a puncture target point (e.g., a solid black point a in fig. 15).

S300, as shown in FIG. 16, a point in the bronchus near the position to be reached is selected as a puncture starting point B.

Among them, a line (straight line segment) from the puncture starting point B to the puncture target point a is required to facilitate the arrival of the catheter and to align the puncture target point a along the line for the subsequent puncture and dilation operations, and to keep the blood vessels (arteries and veins) distinguishable as far as possible, thereby preventing the damage to the blood vessels during the puncture process from causing massive bleeding.

S400, taking the puncture starting point B as a navigation path end point, planning a navigation path from the main carina to the puncture starting point B according to the magnetic navigation path planning step in the prior art, and taking the navigation path as a main navigation path.

S500, as shown in fig. 17, a navigation target point is selected in the bronchus near the lesion position (in a direction deeper than the puncture start point B and the puncture target point a), and a navigation path from the puncture start point (or the main carina) to this target point is planned as an auxiliary navigation path for auxiliary positioning.

The auxiliary navigation path helps to judge the specific coordinate range of the position range required to be reached. Preferably, a plurality of navigation target points may be selected to establish a plurality of auxiliary navigation paths (e.g. paths D1, D2, D3 in fig. 17) to try to encompass the range of positions to be reached from different directions.

S600, using a positioning catheter inserted into the guiding catheter, the main navigation path is followed to reach the puncture starting point B (fig. 18).

S700, according to the auxiliary navigation path (e.g., paths D1, D2, D3 in fig. 17) planned in step 500, the positioning catheters inserted into the guiding catheters are used to reach the target points of the navigation path respectively, and then return to the puncture starting point B.

Specifically, the coordinates of the path actually traversed in the magnetic navigation positioning system are recorded in the process. And comparing the coordinates with navigation path coordinates in a three-dimensional model of the bronchial tree structure so as to correct the position range to be reached, the puncture target point A and the puncture starting point B, so that the coordinates of the puncture starting point B and the puncture target point A in the magnetic navigation positioning system are matched with the coordinates in the three-dimensional model of the bronchial tree structure, thereby reducing positioning errors and errors of subsequent puncture steps and improving the accuracy.

And S800, taking the positioning catheter out of the guide catheter, and placing the puncture wall breaking device. The front end of the puncture wall breaking device reaches a puncture starting point B and faces a puncture target point A. The sheath tube 10 and the guide tip 20 are kept still, and the puncture needle 30 is inserted forward a certain distance (see fig. 19) (which may or may not reach the puncture target point a) and then removed.

Wherein X-rays or CT can also be used to confirm the orientation and position of the needle 30 during the puncture procedure. Optionally, the leading end of the introducer 20 or sheath 10 or the leading section of the puncture needle 30 may be provided with magnetic navigation position sensors to determine the actual position and direction of advancement of the puncture needle 30 to align the puncture site. The positioning catheter in the steps S600-S800 can be omitted, and the puncture wall breaking device with the magnetic navigation positioning sensor can be directly used for reaching the puncture starting point B.

S900, as shown in fig. 20, the puncture needle 30 holding the guide tube and the puncture wall-breaking device is not moved, and the outer sheath tube 10 of the puncture wall-breaking device is pushed forward, so that the guide tip 20 enters the tissue in the direction of the puncture needle 30, and the path to the puncture target point a is enlarged.

S1000, as shown in fig. 21, the outer sheath 10 and the puncture needle 30 of the puncture wall-breaking device are kept still, and the guide catheter is pushed to enter the tissue along the path generated by the puncture wall-breaking device to reach or approach the puncture target point A.

S2000, as shown in fig. 22, the puncture wall breaking device is withdrawn from the guide catheter. A biopsy tool (e.g., a biopsy needle, a biopsy forceps, a cell brush, etc., without limitation) is inserted into the guide catheter to reach the puncture target site a to take a tissue sample.

Optionally, after the tissue sample is obtained at the puncture target point, the tissue sample can be replaced by an ablation catheter with a magnetic navigation positioning sensor for ablation treatment.

Alternatively, procedures and methods for performing the procedure under a bronchoscope (no guiding catheter, non-magnetic field environment) may be selected. FIG. 24 is a flow chart of a puncture wall breaking device operating in a non-magnetic field environment without a guiding catheter under a bronchoscope; as shown in fig. 24, the specific operation steps are as follows:

s201, the bronchoscope is operated to extend to the position near the lesion position, and the bronchoscope can be confirmed by CT or X-ray. And adjusting the orientation of the front end of the bronchoscope, and selecting a point in the bronchus near the position to be reached as a puncture starting point.

Specifically, the line (straight line segment) from the puncture initiation point to the puncture target point is required to facilitate the arrival of the catheter and to align the puncture target point along this line for the subsequent puncture and dilation operations, and to keep the blood vessels (arteries and veins) as far away as possible from the distinguishable ones, to prevent the damage to the blood vessels during the puncture process from causing excessive bleeding. X-rays or CT can be used to confirm that the needle start point and puncture path are appropriate.

S202, the front end of the puncture wall breaking device reaches the puncture starting point and faces to the puncture target point. Keeping the sheath tube and the guide head still, and inserting the puncture needle forwards for a certain distance (which can reach or not reach a puncture target point) and then taking out. The puncture procedure may also use X-rays or CT to confirm the orientation and position of the puncture needle.

S203, fixing the bronchoscope and the puncture needle of the puncture wall breaking tool to be immobile, and pushing the outer sheath tube of the puncture wall breaking tool forward to enable the guide head to invade tissues along the direction of the puncture needle, so as to enlarge a passage reaching a target position. The procedure may use X-rays or CT to confirm orientation and position.

And S204, withdrawing the puncture wall breaking device from the bronchoscope. A biopsy tool (e.g., without limitation, a biopsy needle, biopsy forceps, a cell brush, etc.) is inserted into the bronchoscope to reach the target location to take a tissue sample.

S205, after the tissue sample is obtained at the puncture target point, the ablation catheter can be replaced by the ablation catheter for ablation treatment.

Alternatively, procedures and methods for performing the procedure under a bronchoscope (including a guiding catheter, non-magnetic field environment) may be selected. Fig. 25 is a flow chart of the puncture wall breaking device for operation in a non-magnetic field environment with a guiding catheter under a bronchoscope. The specific operation steps are as follows:

s301, the bronchoscope is operated to extend to the position near the lesion position and can be confirmed by CT or X-ray. And adjusting the orientation of the front end of the bronchoscope, and selecting a point in the bronchus near the position to be reached as a puncture starting point.

Specifically, the line (straight line segment) from the puncture initiation point to the puncture target point is required to facilitate the arrival of the catheter and to align the puncture target point along this line for the subsequent puncture and dilation operations, and to keep the blood vessels (arteries and veins) as far away as possible from the distinguishable ones, to prevent the damage to the blood vessels during the puncture process from causing excessive bleeding. X-rays or CT can be used to confirm that the needle start point and puncture path are appropriate.

S302, the front end of the puncture wall breaking device reaches the puncture starting point and faces to the puncture target point. Keeping the sheath tube and the guide head still, and inserting the puncture needle forwards for a certain distance (which can reach or not reach a puncture target point) and then taking out. The puncture procedure may also use X-rays or CT to confirm the orientation and position of the puncture needle.

And S303, fixing the bronchoscope and the puncture needle of the puncture wall breaking tool to be immobile, and pushing the outer sheath tube of the puncture wall breaking tool forward to enable the guide head to invade tissues along the direction of the puncture needle, so as to enlarge a passage reaching a target position. The procedure may use X-rays or CT to confirm orientation and position.

S304, keeping the sheath tube and the puncture needle of the puncture wall-breaking device stationary, and pushing the guide catheter to enable the guide catheter to enter the tissue to reach or approach the target position along the path generated by the puncture wall-breaking tool.

S305, the puncture wall breaking device is withdrawn from the bronchoscope, the guide catheter is left as a passage, and a biopsy tool (for example, a biopsy needle, a biopsy forceps, a cell brush, or the like, but not limited thereto) is inserted into the guide catheter to reach a target position to obtain a tissue sample.

And S306, after the tissue sample is obtained at the puncture target point, the ablation catheter can be replaced by the ablation catheter for ablation treatment.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.