CN114947995A

CN114947995A - Biopsy forceps

Info

Publication number: CN114947995A
Application number: CN202110198870.4A
Authority: CN
Inventors: 黄景川; 杨帆
Original assignee: Changzhou Lunghealth Medtech Co ltd
Current assignee: Changzhou Lunghealth Medtech Co ltd
Priority date: 2021-02-22
Filing date: 2021-02-22
Publication date: 2022-08-30

Abstract

The embodiment of the invention discloses biopsy forceps, which comprise an insertion assembly, a forceps head assembly and a positioning assembly, wherein the insertion assembly is tubular and is used for inserting a body of an organism; the forceps head assembly is connected to the end of the insertion assembly and driven by the insertion assembly to reach a focus position of the body; the positioning assembly is arranged at the end part, close to the forceps head assembly, in the insertion assembly and is used for positioning the forceps head assembly in the muscle body. According to the biopsy forceps provided by the embodiment of the invention, the location of the forceps head assembly in the muscle of the organism is located through the locating assembly, so that the location of a biopsy tool is accurately determined, the focus sampling is more accurate, and the biopsy accuracy is further improved.

Description

Biopsy forceps

Technical Field

The invention relates to the technical field of medical instruments, in particular to a biopsy forceps.

Background

In modern medicine, endoscopy has become increasingly important for the early detection and treatment of tumors. The conventional endoscopy can enter a natural cavity of a human body to acquire an image at the front end of the endoscope for observation, and biopsy tools are used for clamp examination, brush examination and needle suction examination of living tissues, so that the diseases are correctly diagnosed. Usually these biopsy procedures are performed under direct vision under an endoscopic imaging system. However, for the focus which can not be reached and seen by the endoscope in the natural cavity deep or behind the cavity wall, the doctor can not visually identify through the imaging system, so that the biopsy tool can not be accurately positioned, and therefore the tissue of the target focus can not be obtained or the tissue which is not the target focus can not be obtained, and misdiagnosis can be caused. Although the position of the focus can be calibrated by using the magnetic navigation positioning system, the position of a biopsy tool in a human body can not be accurately determined when the focus is subjected to clamp detection, brushing detection and needle suction detection, so that the focus sampling is easy to be inaccurate, and the accuracy of biopsy is further influenced.

Disclosure of Invention

The embodiment of the invention provides a biopsy forceps which can accurately determine the position of a biopsy tool in a human body, accurately sample a focus and improve the accuracy of biopsy.

The biopsy forceps provided by the embodiment of the invention comprises:

an insertion assembly having a tubular shape for insertion into a body of a living being;

the forceps head assembly is connected to the end of the insertion assembly and driven by the insertion assembly to reach a focus position of the body;

and the positioning assembly is arranged at the end part, close to the forceps head assembly, in the insertion assembly and is used for positioning the position of the forceps head assembly in the muscle body.

Further, the binding clip subassembly includes:

the first binding clip and the second binding clip are hinged with each other, and each of the first binding clip and the second binding clip comprises a cup part and a first connecting part which are positioned at two sides of a hinge point;

the pull rod is connected with the first connecting portion and used for driving the two clamp cup portions to approach or separate from each other.

Further, the opposing faces of the two cup portions are flat or alligator faces.

Furthermore, cleaning holes are formed in the two cup portions.

Furthermore, one end of the cup portion, which is far away from the first connecting portion, is spherical.

Further, the method also comprises the following steps:

the binding clip gasket is arranged on the hinge point in a penetrating mode and located between the first binding clip and the second binding clip.

Furthermore, the binding clip gasket is of a circular ring type or an arrow-point type.

Furthermore, the tong head assembly further comprises a tong head seat which is of a hollow structure and is used for the pull rod to move in a reciprocating mode, and the tong head seat comprises a head end part, a slotted part and a second connecting part;

the end part of the head is provided with a through hole, a binding clip pin is arranged in the through hole, and the first binding clip and the second binding clip penetrate through the binding clip pin to form hinge joint;

the first and second binding clip rotate about the binding clip pin within the slotted portion;

the second connecting portion connects the insert assembly.

Further, the head end part is smooth;

the tong head pin is a cylindrical shaft, and the radian of the two ends of the tong head pin is consistent with that of the surface of the head end part.

Further, the tong head assembly also comprises a connecting piece;

the connecting piece comprises a connecting male piece and a connecting female piece which are positioned in the groove part, one end of the connecting male piece and one end of the connecting female piece are connected with the pull rod, and the other end of the connecting male piece and the other end of the connecting female piece are respectively connected with the first connecting part of the first tong head and the first connecting part of the second tong head.

Further, the insertion assembly includes an inner tube and an outer tube, the inner tube being located within the outer tube and reciprocating within the outer tube;

one end of the outer pipe is connected with the second connecting part, and one end of the inner pipe is connected with the end part of the pull rod far away from the hinge point;

the positioning assembly is arranged in the inner pipe and is close to the position of the hinge point.

Furthermore, the end part of the pull rod, which is far away from the hinge point, is of a hollow structure, and the positioning assembly is arranged in the hollow structure.

Furthermore, the pull rod is far away from the periphery of the end part of the hinged point is provided with a connecting structure, and the inner pipe is connected to the connecting structure.

Furthermore, the outer pipe is a stainless steel flat wire/round wire tightly-wound spring pipe or a multilayer structure braided pipe consisting of a plastic layer, a metal braided wire layer and a plastic layer from inside to outside.

Furthermore, the inner tube is any one of a single-cavity stainless steel flat wire/round wire close-wound spring tube, a laser-cut stainless steel flexible snake bone tube, a single-cavity multilayer structure braided tube, a single-cavity/multi-cavity plastic tube, a single-cavity multi-strand hollow steel wire rope wound by stainless steel wires and a bendable thin-wall metal tube, or is formed by splicing multiple sections of the above structural forms;

the single-cavity multilayer structure braided tube comprises a plastic layer, a stainless steel braided wire layer and a plastic layer from inside to outside.

Furthermore, the insertion assembly further comprises a limiting block, wherein the limiting block is arranged outside the outer pipe in a penetrating mode and can move along the surface of the outer pipe in a reciprocating mode.

Further, the locating component comprises a magnetic navigation locating sensor which is integrally formed with the pull rod, and the magnetic navigation locating sensor is arranged in the end portion, close to the hinge point, of the inner pipe.

Further, the positioning assembly comprises a magnetic navigation positioning sensor and a sensor protective cap;

magnetic navigation positioning sensor establishes in the sensor protective cap, the sensor protective cap is established the inner tube is close to in the tip of pin joint, just the sensor protective cap is close to the tip of pin joint is the sealed end, keeps away from the tip of pin joint is the open end.

Further, locating component still includes sensor protection sheath pipe, sensor protection sheath pipe wears to establish in the inner tube, sensor protection sheath pipe is close to the end connection of pin joint the sensor protective cap.

Further, a handle assembly comprising a hand-held portion, a distal portion, and a proximal portion;

the hand-held part comprises a movable hand-held part and a fixed hand-held part;

the movable handheld part is connected with the end of the inner pipe far away from the forceps head assembly, and the distal end part is connected with the end of the outer pipe far away from the forceps head assembly;

and the handle assembly is provided with a compression spring which enables the distal end part and the handheld part to move relatively, and the compression spring is respectively connected with the distal end part and the handheld part.

Further, a channel part communicated with the inner tube is arranged in the handle assembly, and an interface part communicated with the channel part is arranged at the end part of the proximal end part.

The biopsy forceps comprise the insertion assembly and the forceps head assembly which are connected with each other, the positioning assembly is arranged in the end portion, close to the forceps head assembly, of the insertion assembly, the position of the forceps head assembly in a muscle of an organism is positioned through the positioning assembly, the position of a biopsy tool is accurately determined, focus sampling is more accurate, and biopsy accuracy is improved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention and not to limit the invention. In the drawings:

FIG. 1 is a schematic view of a partial cross-sectional structure of a biopsy forceps according to an embodiment of the present invention;

FIG. 2 is a perspective view of a forceps head assembly of a biopsy forceps according to an embodiment of the present invention;

fig. 3 is a schematic perspective view of a first forceps head or a second forceps head of a biopsy forceps according to an embodiment of the present invention;

FIG. 4 is a schematic perspective view of another first or second head of a biopsy forceps according to an embodiment of the present invention;

FIG. 5 is a side view of a pad of a biopsy forceps head according to an embodiment of the present invention;

FIG. 6 is a side view of another exemplary pad of a biopsy forceps, according to an embodiment of the present disclosure;

FIG. 7 is a schematic perspective view of a forceps head seat of a biopsy forceps according to an embodiment of the present invention;

FIG. 8 is a perspective view of a connector of a bioptome according to an embodiment of the present invention;

FIG. 9a is a perspective view of a pull rod of a biopsy forceps according to an embodiment of the present invention;

FIG. 9b is a schematic diagram illustrating another perspective structure of a pull rod of a biopsy forceps according to an embodiment of the present invention;

FIG. 10 is a cross-sectional view of an inner tube of a bioptome according to an embodiment of the present invention;

FIG. 11 is a cross-sectional view of an alternative inner tube of a bioptome according to an embodiment of the present invention;

FIG. 12 is a side view of a biopsy forceps according to an embodiment of the present invention;

FIG. 13 is a cross-sectional view of a positioning assembly of a bioptome according to one embodiment of the present invention;

fig. 14-23 are schematic flow charts illustrating a method of operating a bioptome according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. 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 obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

Referring to fig. 1, a cross-sectional view of a biopsy forceps according to an embodiment of the present invention is shown, the biopsy forceps includes an insertion assembly 10, a forceps head assembly 20, and a positioning assembly 30.

Wherein the insertion assembly 10 is tubular for insertion into a body of a living being; the forceps head assembly 20 is connected to the end of the insertion assembly 10 and driven by the insertion assembly 10 to reach the lesion position of the body; the positioning assembly 30 is disposed at an end of the insertion assembly 10 proximate to the forcep assembly 20 for positioning the forcep assembly 20 within the body.

Specifically, the tubular insertion assembly 10 is used for being inserted into a body of a living body, where the living body includes an animal body, a human body, etc., and the human body is taken as an example, the insertion assembly 10 enters the human body under the action of a machine or a human, the front end of the insertion assembly 10 is connected with the forceps head assembly 20, the forceps head assembly 20 can be conveyed to a lesion position in the human body along with the movement of the insertion assembly 10 in the human body, and the forceps head assembly 20 can sample a lesion of the human body; the positioning assembly 30 is disposed at an end of the insertion assembly 10 close to the forceps head assembly 20, that is, at a front end of the insertion assembly 10, the positioning assembly 30 is disposed in a tube of the insertion assembly 10 and moves in a human body along with the insertion assembly 10, and the positioning assembly 30 has a positioning function, and can position the forceps head assembly 20 in the human body, so as to accurately determine the position of the forceps head assembly 20, so that a lesion is sampled more accurately, and further, the accuracy of biopsy is improved.

The insertion assembly 10, the bit assembly 20, and the positioning assembly 30 will be described in detail with reference to fig. 2-13.

The binding clip assembly 20 includes a first binding clip 210 and a second binding clip 220 hinged to each other, and each of the first binding clip 210 and the second binding clip 220 includes a clip cup 201 and a first connecting portion 202 located at two sides of a hinge point 230; the binding clip assembly 20 further comprises a pull rod 240, wherein the pull rod 240 is connected to the first connecting portion 202 for moving the two cup portions 201 toward or away from each other.

Specifically, the first jaw 210 and the second jaw 220 may rotate around the hinge point 230, so that the two cup portions 201 located at the front end of the hinge point 230 are close to each other or separated from each other, wherein the two cup portions 201 are close to each other to sample a lesion, and the two cup portions 201 are separated from each other to release the sample of the pinched lesion. At the ends of the first and

second bits

210 and 220 away from the cup portion 201 are the first connection portions 202 connected to the pull rod 240, and the two cup portions 201 are moved toward or away from each other by the pull rod 240 reciprocating in a direction from the hinge point 230 to the hinge point 230.

It should be further noted that the first binding clip 210 and the second binding clip 220 may be made of materials including, but not limited to, stainless steel materials, and may be made by powder metallurgy/machining/punching; also, the pull rod 240 may be made of a stainless steel material, such as powder metallurgy, machining, and stamping.

Further, the opposing faces of the two cup portions 201 are flat or alligator faces.

Specifically, as shown in fig. 3, the opposite surfaces of the two cup portions 201 are planes, and when the two cup portions 201 approach each other, the planes of the two cup portions 201 can be attached to each other, so that a lesion sample can be pinched; in another preferred embodiment, as shown in fig. 4, the two opposing faces of the cup portions 201 are crocodile faces, and when the two cup portions 201 approach each other, the crocodile faces of the two cup portions 201 can be engaged with each other, so that not only can a lesion sample be pinched, but also the firmness during sampling can be improved, and the reliability of sampling the lesion can be improved.

Furthermore, both the cup portions 201 are provided with cleaning holes 204.

Specifically, the cleaning hole 204 is perpendicular to the opposite surfaces of the two cup portions 201, and the cleaning hole 204 can allow liquid for cleaning the forceps head to pass through, so that a lesion sample in the forceps cup can be conveniently brushed away, and the convenience for cleaning the first forceps head 210 and the second forceps head 220 is improved.

In addition, an end of the cup portion 201 away from the first connection portion 202 is spherical.

Specifically, the ends of the cup portions 201 of the first forceps head 210 and the second forceps head 220, which are away from the pull rod, are spherical, that is, the head ends of the first forceps head 210 and the second forceps head 220 are spherical, and here, the spherical head ends have the advantage of facilitating movement in the body, and improve comfort when performing biopsy on human tissue.

Further, the binding clip assembly further includes a binding clip gasket 250, and the binding clip gasket 250 is disposed on the hinge point 230 and located between the first binding clip 210 and the second binding clip 220.

Specifically, the first binding clip 210 and the second binding clip 220 are connected by means of a shaft pin at the hinge point 230, the binding clip gasket 250 is disposed on the shaft pin in a penetrating manner and clamped between the first binding clip 210 and the second binding clip 220, two surfaces of the binding clip gasket 250 are respectively in contact with the first binding clip 210 and the second binding clip 220, and a friction coefficient of a contact surface is small, so that the smoothness when the first binding clip 210 and the second binding clip 220 rotate relatively is improved, and the first binding clip 210 and the second binding clip 220 are prevented from being locked when they move relative to each other.

Further, the jaw pad 250 is circular or arrowhead.

Specifically, as shown in fig. 5, the bit pad 250 may be a circular ring type, specifically, a circular ring-shaped sheet having a central through hole portion 251 and an outer peripheral portion 252; the forcep head gasket 250 may be of an arrow-cluster type, specifically, an arrow-cluster-shaped sheet having a puncturing portion 253, a through hole portion 251, an outer circumferential portion 252, and a connecting portion 254 between the puncturing portion 253 and the through hole portion 251, as shown in fig. 6, the arrow-cluster-type puncturing portion 253 is used for puncturing a hard lesion to sample, thereby increasing the sampling success rate of the forcep head assembly 20.

The clamp head gasket 250 may be made of, but not limited to, stainless steel, and may be made by powder metallurgy, machining, stamping, and the like.

Further, referring to fig. 7, the bit assembly 20 further includes a bit seat 260, the bit seat 260 is a hollow structure for the pull rod 240 to reciprocate, and includes a head end portion 261, a slotted portion 262 and a second connecting portion 263;

the head end 261 is provided with a through hole 2611, a forcep pin 2612 is arranged in the through hole 2611, and the first forcep head 210 and the second forcep head 220 are arranged on the forcep pin 2612 in a penetrating mode to form hinge connection;

the first and

second bits

210 and 220 rotate about the bit pin 2612 within the slotted portion 262;

the second connection portion 263 connects the insert assembly 10.

Specifically, the bit holder 260 is formed of a cylindrical hollow structure, wherein the hollow structure allows the pull rod 240 to reciprocate therein, and the bit end portion 261 and the second connecting portion 263 are respectively disposed at two ends of the slot portion 262. The through hole 2611 is arranged at the front end of the groove 262, the through hole 2611 is the position of the hinge point 230, the inside of the through hole is provided with the forcep pin 2612, the forcep pin 2612 is the shaft pin for realizing the hinge joint of the first forcep head 210 and the second forcep head 220 in the above embodiment, the forcep pin 2612 passes through the through hole 2611 on one side, the pin hole 203 on the first forcep head 210, the forcep pad 250, the pin hole 203 on the second forcep head 220 and the through hole 2611 on the other side, so that the first forcep head 210 and the second forcep head 220 can be hinged with each other and the first forcep head 210 and the second forcep head 220 can be connected with the forcep seat 260, the groove 262 is used for accommodating the part between the first connecting part 202 of the first forcep head 210 and the second forcep head 220 and the hinge point 230 and enabling the part to rotate in the groove 262, and the pull rod 240 reciprocates in the forceps head seat 260 to drive the forceps cups of the first forceps head 210 and the second forceps head 220 to approach or separate from each other, so as to complete the pinching and releasing of the lesion sample.

Further, the head end portion 261 is rounded; the jaw pin 2612 is a cylindrical shaft, and both ends of the jaw pin are in accordance with the radian of the surface of the head end 261.

Here, the smooth head end 261 can facilitate the entry of the forceps head seat 260 into various cavities of the body and avoid cutting the cavities; and the radian of the forceps head pin 2612 of the cylindrical shaft and the radian of the end surface of the forceps head pin is consistent with that of the surface of the head end part 261, so that the damage of sharp edges and corners at the structural connection part to body tissues can be avoided, and the comfort of biopsy sampling is improved.

Similarly, the components of the tool holder 260 may be made of materials including, but not limited to, stainless steel, and may be made by powder metallurgy/machining/stamping.

Additionally, the forcep head assembly 20 further includes a connector 270;

the connecting member 270 includes a male connecting member 271 and a female connecting member 272 located in the groove 262, one end of the male connecting member 271 and one end of the female connecting member 272 are connected to the pull rod 240, and the other end of the male connecting member 271 and the other end of the female connecting member are connected to the first connecting portion 202 of the first tong head 210 and the second tong head 220, respectively.

Specifically, referring to fig. 8, each of the male connecting member 271 and the female connecting member 272 has a connecting platform 273, wherein base pillar portions 274 are respectively disposed at two ends of one side surface of the connecting platform 273 of the male connecting member 271, and one end of one side surface of the connecting platform 273 of the female connecting member 272 is provided with the base pillar portion 274, and the other end is provided with the base hole portion 275. The first connection portion 202 of the first tong head 210 and the second tong head 220 is provided with a connection hole 205, the connection hole 205 of the first tong head 210 is connected with one of the base column portions 274 of the connection male member 271, and the connection hole 205 of the second tong head 220 is connected with the base column portion 274 of the connection female member 272; the end of the pull rod 240 is also provided with a connecting hole 205, and the other base pillar portion 274 of the connecting male member 271 sequentially passes through the connecting hole 205 of the pull rod 240 and the base hole portion 275 of the connecting female member 272, so as to complete the connection between the pull rod 240, the connecting member 270, and the first tong head 210 and the second tong head 220. The slotted portion 262 provides a space for the connecting member 270 and the ends of the first and

second bits

210 and 220 to move in the whole process by the reciprocating movement of the pull rod 240, so that the connecting member 270 acts on the first and

second bits

210 and 220 and the cups thereof are moved closer to or away from each other.

Also, the components of the connector 270 may be made of materials including, but not limited to, stainless steel, and may be made by powder metallurgy/machining/stamping, etc.

Further, the insertion assembly 10 includes an inner tube 110 and an outer tube 120, the inner tube 110 being located inside the outer tube 120 and reciprocating inside the outer tube 120;

one end of the outer tube 120 is connected to the second connecting portion 263, and one end of the inner tube 110 is connected to the end of the pull rod 240 away from the hinge point 230;

the positioning assembly 30 is disposed within the inner tube 110 and adjacent to the hinge point 230.

Specifically, the insertion assembly 10 includes a sleeve assembly composed of the inner tube 110 and the outer tube 120, the inner tube 110 is located inside the outer tube 120, and the inner tube 110 and the outer tube 120 are not fixed relatively but can perform a relative reciprocating motion along the length direction of the tube body.

The end of the outer tube 120 is sleeved on the second connecting portion 263 of the forceps head holder 260, the second connecting portion 263 is a stepped structure with a diameter smaller than that of the notch portion 262, the end of the outer tube 120 is sleeved on the stepped structure, and after connection is completed, the outer periphery of the insertion assembly 10 is just flush with the outer periphery of the forceps head holder 260, so that the insertion assembly 10 drives the forceps head assembly 20 to move in body tissues.

The positioning assembly 30 is disposed in the inner tube 110 and is close to the hinge point 230 to better position the bit assembly 20, and the specific location of the positioning assembly 30 will be described below.

In a preferred embodiment of the present invention, the end of the pull rod 240 away from the hinge point 230 is a hollow structure 243, and the positioning assembly 30 is disposed in the hollow structure 243.

One end of the inner tube 110 is connected to one end of the pull rod 240 away from the bit, where the pull rod 240 includes a head 241, a tail 242 and the hollow structure 243, as shown in fig. 9a, wherein the hollow structure 243 is disposed at the tail 242 with a depth toward the hinge point 230 for the insertion connection of the inner tube 110, the head 241 is provided with a connection hole 205, the connection hole 205 is used for connecting the first bit 210 and the second bit 220, and the pull rod 240 is disposed in the hollow structure of the bit holder 260.

The positioning assembly 30 is disposed in the inner tube 110 and located at an end portion close to the head portion 241 of the pull rod 240, the positioning assembly 30 abuts against the bottom of the hollow structure 243 of the pull rod, and reciprocates in the outer tube 120 together with the pull rod 240 and the inner tube 110, that is, the bit assembly 20 at the front end of the pull rod 240 is positioned, so as to precisely obtain the position of the bit assembly 20 in the body tissue.

Further, one end of the inner tube 110 may be sleeved on one end of the pull rod 240 away from the forceps head, where the pull rod 240 includes a head portion 241, a tail portion 242, and a transition portion 244, as shown in fig. 9 b. The tail part 242 is inserted into the outer tube 120, the inner tube 110 is sleeved on the tail part 242, a stepped structure is arranged between the tail part 242 and the transition part 244, the diameter of the tail part 242 is smaller than that of the transition part 244, and when the inner tube 110 is sleeved on the tail part 242, the stepped structure is just flush with the periphery of the transition part 244, so that the inner tube 110 with the pull rod 240 can smoothly reciprocate relative to the outer tube 120.

More closely, the pull rod 240 the outer peripheral surface of afterbody 242 is equipped with connection structure, connection structure's form includes but not limited to be the combination of one or several of slot, barb, screw thread etc. inner tube 110 cover is established connection structure is last, has the promotion the inner tube 110 with the effect of the firm in connection degree between the pull rod 240 prevents both to break away from the influence and uses.

In a preferred embodiment of the present invention, the outer tube 120 is a stainless steel flat/round wire tightly wound spring tube, or a multi-layer structure woven tube composed of plastic layers, metal woven wire layers and plastic layers from the inside to the outside.

Specifically, the specific winding direction of the tightly wound spring tube is not specifically limited in the embodiments of the present invention, and the tightly wound spring tube has a certain elastic property that varies with the shape of the body tissue cavity, so that the insertion assembly 10 can enter the body tissue and reach the target lesion site under manual or mechanical action, and has a high strength in the radial direction, so as to provide a reciprocating channel for the inner tube 110, so that the relative motion between the two can be facilitated, and further the forceps head assembly 20 can be opened or closed, and the braided tube with a multi-layer structure also has the above characteristics.

In addition, in other preferred embodiments, the outer surface of the tightly wound spring tube made of stainless steel flat/round wires can be added with PET, PE, PTFEP, PP layers, which have better lubrication effect, so as to reduce the surface motion resistance of the outer tube 120, and improve the comfort of the patient when the outer tube 120 moves between human tissues.

Further, in another preferred embodiment of the present invention, the inner tube 110 is any one of a single-lumen stainless steel flat/round tightly wound spring tube, a laser-cut stainless steel flexible snake bone tube, a single-lumen multi-layer braided tube, a single-lumen/multi-lumen plastic tube, a single-lumen multi-strand stainless steel wire wound hollow steel wire rope, and a bendable thin-walled metal tube, or may be formed by multi-segment splicing of the above structural forms;

Optionally, the surface of the tightly wound spring tube of the single-lumen stainless steel round wire/round wire can be added with PET, PE, PTFEP, and PP layers, and these coatings have better lubricating effect, so that the surface movement resistance of the inner tube 110 can be reduced, the smoothness of the outer tube 120 and the inner tube 110 during relative movement can be improved, and the operation sensitivity of the forcep head assembly 20 can be improved.

The material of the single-cavity/multi-cavity plastic pipe can be PE/PP/POM/PTFE/PI/PA/PEEK material.

The single/multi-lumen plastic tube contains at least 1 lumen. The multiple chambers are 1 main chamber 1101+ N sub-chambers 1102, N being 1-4 in number. The subcavities 1102 may be completely within the tubing wall thickness, as shown in fig. 10; the sub-cavity 1102 may also be partially exposed on the outer surface of the tube, as shown in fig. 11, where 1 main cavity 1101+4 sub-cavities 1102 are shown above.

Further, a reinforcing wire 1103 can be inserted into the main cavity 1101 and/or the sub-cavity 1102 for reinforcing the tensile strength of the tube body and connecting with the pulling rod 240 of the forcep head assembly 20 to bear the tensile force. The reinforcing wire 1103 is a single stainless steel round wire or flat wire, or a steel wire rope wound by multiple stainless steel round wires.

The hollow steel wire rope wound by the multi-strand stainless steel wire with the single cavity is spirally wound by the multi-strand stainless steel round wire/flat wire and comprises a plurality of layers.

The number of the multi-strand stainless steel round wires/flat wires is N, and the number of N is 4-12.

The number of the multiple layers is N, and the number of N is 1-3.

In addition, referring to fig. 12, the insertion assembly 10 further includes a stopper 130, and the stopper 130 is disposed outside the outer tube 120 and can reciprocate along the surface of the outer tube 120.

Specifically, the limiting block 130 is disposed outside the outer tube 120 in a penetrating manner, and serves as a depth limiting mark for controlling the insertion assembly 10 to enter the body tissue cavity, and can reciprocate along the surface of the outer tube 120.

In a preferred embodiment, the material of the limiting block 130 includes, but is not limited to, silicone.

Further, the bioptome further includes a handle assembly 40, the handle assembly 40 including a hand-held portion 410, a distal portion 420, and a proximal portion 430;

the proximal end 430 is connected to the end of the inner tube 110 distal to the forcep assembly 20, and the distal end 420 is connected to the end of the outer tube 120 distal to the forcep assembly 20;

further, a compression spring 440 is disposed on the handle assembly 40 for moving the distal portion 420 and the hand-held portion 410 relatively, and the compression spring 440 is connected to the distal portion 420 and the hand-held portion 410 respectively. Specifically, the hand-held portion 410 is designed ergonomically, in order to adapt to the hand control structure of the operator, the distal portion 420 and the proximal portion 430 are respectively disposed at two sides of the hand-held portion 410, the hand-held portion 410 is provided with a movable hand-held portion 411 and a fixed hand-held portion 412, the distal portion 420 is fixedly connected with the outer tube 120, the movable hand-held portion 411 is fixedly connected with the inner tube 110, the compression spring 440 provided on the handle assembly 40 is respectively connected with the distal portion 420 and the hand-held portion 410, the compression spring 440 can ensure that the relative separation tendency of the distal portion 420 and the hand-held portion 410 is always kept close to each other for entering the body or the channel when in the rest state, and the movable hand-held portion 411 is fixedly connected with the inner tube 110, the operator moves the movable handle 411 and the distal end portion 420 toward or away from each other, so that the outer tube 120 and the inner tube 110 move relatively, and the opposing cups of the first jaw 210 and the second jaw 220 of the jaw assembly 20 approach or separate from each other, thereby closing or opening the biopsy forceps, so as to complete the pinching or releasing of the biopsy forceps on the body tissue lesion sample.

Further, a channel portion (not shown) communicating with the inner tube 110 is provided in the handle assembly 40, and an end portion of the proximal end portion 430 is provided with an interface portion 450 communicating with the channel portion.

Specifically, the channel portion is disposed inside the handle assembly 40 for connecting with the inner tube 110 or disposing the inner tube 110, and the connecting portion 450 is communicated with the channel portion and opened at the end of the proximal portion 430 for a penetration inlet of the inner tube 110, an insertion inlet of the positioning assembly 30, and the like.

Optionally, a connection portion may be disposed on the handle assembly 40 for connecting a dedicated auxiliary consumable/endoscopic forceps channel interface.

Optionally, an interface portion may be provided on the handle assembly 40 for cable plug connection of the positioning assembly.

Further, in a preferred embodiment of the present invention, the positioning assembly 30 includes a magnetic navigation positioning sensor 310 integrally formed with the pull rod 240, and the magnetic navigation positioning sensor 310 is disposed in an end of the inner pipe 110 near the hinge point 230.

Specifically, the magnetic navigation positioning sensor 310 is embedded in the hollow structure 243 of the drawbar 240, and is located as close as possible to the head 241 of the drawbar 240, and the two are integrally formed, and are not required to be detached before and after being used, and the end of the magnetic navigation positioning sensor 310 away from the drawbar 240 is connected to an external device through a sensor cable, where the sensor cable is inserted into the inner tube 110 and passes through the interface portion 450 to be connected to the external device, and the external device includes but is not limited to a magnetic navigation device or other display devices.

In addition, in another preferred embodiment of the present invention, the positioning assembly 30 includes a magnetic navigation positioning sensor 310 and a sensor protection cap 320; the magnetic navigation positioning sensor 310 is disposed in the sensor protection cap 320, the sensor protection cap 320 is disposed in an end portion of the inner tube 110 close to the hinge point 230, an end portion of the sensor protection cap 320 close to the hinge point 230 is a sealing end, and an end portion far away from the hinge point 230 is an opening end.

In particular, in the present embodiment, a split structure is provided between the positioning assembly 30 and the bit assembly 20 (the pull rod 240), the sensor protective cap 320 is disposed at the end of the inner tube adjacent to the bit assembly 20, wherein the end part close to the binding clip assembly 20 is a sealing end, the end part far away from the binding clip assembly 20 is an opening end, the magnetic navigation positioning sensor 310 enters the sensor protective cap 320 from the open end and is placed into the sealed end, such that the sensor protective cap 320 protects the magnetic navigation positioning sensor 310, at the end of the magnetic navigation positioning sensor 310 remote from the forcep assembly 20, the sensor cable is connected to an external device, where the sensor cable is threaded into the inner tube 110, and out of the interface portion 450 to interface with external devices, including but not limited to magnetic navigation devices or other display devices.

Further, referring to fig. 13, in order to facilitate the placement and removal of the magnetic navigation positioning sensor 310, the positioning assembly 30 further includes a sensor protection sheath 330, the sensor protection sheath 330 is disposed through the inner tube 110, and an end of the sensor protection sheath 330 close to the hinge point 230 is connected to the sensor protection cap 320.

Specifically, the sensor protection sheath 330 serves as an introducer sheath for placing and removing the magnetic navigation positioning sensor 310, the magnetic navigation positioning sensor 310 is placed in the sensor protection cap 320, the open end of the sensor protection cap 320 is connected with the end of the sensor protection sheath 330, and the connector of the sensor protection cap 320 and the sensor protection sheath 330 enters the inner tube 110 from the interface part 450, and then reaches a position close to the forceps head assembly 20 for positioning. For the connection between the magnetic navigation positioning sensor 310 and the external device, reference may be made to the description of the above embodiments, which are not repeated herein.

The method of using the biopsy forceps, and in particular the procedure and method of performing a localized lung biopsy with the forceps under magnetic navigation conditions, is described in detail below. FIGS. 14-17 are flow charts of lung biopsy with the bioptome under magnetic navigation through a guide catheter.

S100: CT images are imported and three-dimensional models of the pulmonary bronchial tree structure and of the pulmonary vessels (arteries and veins) are 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 lesion point A needing to be sampled is outlined, as shown in figure 14.

S300, with the focus point a as the navigation path end point, planning a navigation path from the main carina to the focus point a according to the magnetic navigation path planning procedure in the prior art, as shown in fig. 15.

And S400, inserting the magnetic navigation positioning biopsy forceps into the guide catheter and connecting the magnetic navigation positioning biopsy forceps with a magnetic navigation positioning system.

S500, the operation finger guides the tube to reach a focus point A along the navigation path, as shown in figure 16.

S600, operating the handle of the magnetic navigation positioning biopsy forceps to perform biopsy sampling, and performing biopsy sampling as shown in figure 17.

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 the three-dimensional model of the bronchial tree structure, so as to correct the coordinates of the focus point A to be reached in the magnetic navigation positioning system to be matched with the coordinates in the three-dimensional model of the bronchial tree structure, thereby reducing positioning errors and errors of later in vivo sampling and improving the accuracy.

Alternatively, in steps S200-S600, if the target lesion is behind the tracheal wall or there is no significant tracheal access, as shown at point B in fig. 18, a puncture wall breaking tool is used to manually create a pathway to the target lesion. The method comprises the following steps:

referring to fig. 18, a lesion point B to be sampled is outlined in S200. Meanwhile, a puncture wall breaking point B' is drawn, and the position which is as close as possible to the point B or the position which is convenient for puncture is selected.

As shown in fig. 18, in S300, a main navigation path from the main carina to the puncture point B 'is planned according to the magnetic navigation path planning procedure in the prior art, with the puncture point B' as the navigation path end point. Meanwhile, a puncture path from the puncture point B 'to the focus point B is planned as a secondary navigation path by taking the puncture point B' as a starting point and the focus point B as an end point.

Referring to fig. 19, in S400, a puncture wall breaking tool is inserted into the guide catheter to make a puncture starting from the puncture point B' to create a passage leading to the focal point B.

As shown in fig. 20, in S500, the guide catheter and the puncture wall breaking tool are operated to puncture along the secondary navigation path to reach the lesion point B, and then the wall breaking tool is withdrawn to insert the magnetic navigation positioning biopsy forceps.

In fig. 21, the handle of the magnetic navigation positioning biopsy forceps is operated in S600 to perform biopsy sampling.

Optionally, in steps S400-S500, the positioning assembly 30 may be integrated into a magnetic navigation positioning biopsy forceps of the biopsy forceps, or the positioning assembly 30 may be used as a magnetic navigation positioning biopsy forceps of a separate assembly/product.

Optionally, in steps S400-S500, when the positioning assembly 30 is used as a magnetic navigation positioning biopsy forceps of a separate assembly/product, the positioning assembly 30 may be directly inserted into the guiding catheter first, and the guiding catheter may be operated to reach the focal point a. The positioning assembly 30 is then withdrawn and assembled into a biopsy forceps to form a magnetic navigation positioning biopsy forceps, which is then inserted into the guide catheter and extended out of the distal end thereof for sampling. The reason for this is that the distal end of the biopsy forceps is a long metal entity, which affects the curved shape of the distal end of the guide catheter, and causes that the guide catheter is difficult to use a specific curved shape to select a corresponding tracheal bifurcation to enter at the tracheal bifurcation, so that the guide catheter is difficult to smoothly reach a target lesion site along a navigation path, and the operation time is prolonged.

Optionally, when the positioning assembly is used as a magnetic navigation positioning biopsy forceps of an independent assembly/product, after biopsy of the biopsy forceps, the positioning assembly can be drawn out on site, disinfected and wiped, and then inserted into other tools such as forceps, brushes, needles and the like which can realize guidance of a magnetic navigation system to perform multiple composite biopsies, so as to improve the positive detection rate.

Alternatively, in step S400-500, if the target lesion site is located in a shallow lung, it can be reached by using a bronchoscope and directly observed visually by using its imaging system, such as lesion site C in fig. 22. Or the bronchoscope can not be observed by the imaging system directly after arriving, but the focus point clings to the back of the trachea wall, such as focus point D in fig. 23 (correspondingly, a tool or a method should be used to puncture the trachea wall in advance, such as a special puncture wall breaking tool, or a biopsy forceps, a biopsy brush or a biopsy needle with a puncture head). The magnetic navigation positioning biopsy forceps can be directly inserted into the bronchoscope forceps channel without using a guide catheter, extend out of the front end of the forceps channel and enter the focus position for sampling.

It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in the process, method, article, or apparatus that comprises the element.

As will be appreciated by one skilled in the art, embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, and the like) having computer-usable program code embodied therein.

The above description is only an example of the present invention, and is not intended to limit the present invention. Various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. Biopsy forceps, characterized by comprising:

the forceps head assembly is connected to the end part of the insertion assembly and driven by the insertion assembly to reach the focus position of the body;

and the positioning assembly is arranged at the end part, close to the tong head assembly, in the insertion assembly and is used for positioning the position of the tong head assembly in the muscle body.

2. The biopsy forceps of claim 1, wherein the forceps head assembly comprises:

3. Biopsy forceps according to claim 2, wherein the facing surfaces of the two cup portions are flat or alligator surfaces.

4. The bioptome of claim 2, wherein both of the cup portions have a cleaning aperture therein.

5. The bioptome of claim 2, wherein an end of the cup portion distal to the first connection is spherical.

6. The bioptome of claim 2, further comprising:

7. The biopsy forceps of claim 6, wherein the head washer is circular or arrowhead.

8. The biopsy forceps of claim 2, wherein the forceps head assembly further comprises a forceps head seat, the forceps head seat is a hollow structure for the pull rod to reciprocate and comprises a head end portion, a slotted portion and a second connecting portion;

the second connecting portion connects the insert assembly.

9. The bioptome of claim 8, wherein the head end is rounded;

10. The bioptome of claim 8, wherein the jaw assembly further comprises a connector;

11. The bioptome of claim 8, wherein the insertion assembly includes an inner tube and an outer tube, the inner tube being positioned within the outer tube and reciprocating within the outer tube;

12. The bioptome of claim 11, wherein an end of the pull rod distal to the hinge point is a hollow structure, and the positioning assembly is disposed within the hollow structure.

13. Biopsy forceps according to claim 11, wherein the pull rod is provided with a connection structure on the periphery of its end remote from the hinge point, the inner tube being connected to the connection structure.

14. The biopsy forceps of claim 11, wherein the outer tube is a stainless steel flat/round wire tightly wound spring tube or a multi-layer braided tube consisting of a plastic layer, a metal braided wire layer and a plastic layer from inside to outside.

15. The biopsy forceps of claim 11, wherein the inner tube is any one of a single-cavity stainless steel flat/round wire tightly-wound spring tube, a laser-cut stainless steel flexible snake bone tube, a single-cavity multilayer structure braided tube, a single-cavity/multi-cavity plastic tube, a single-cavity multi-strand stainless steel wire wound hollow steel wire rope and a bendable thin-wall stainless steel tube, or is formed by multi-segment splicing of the above multiple structural forms;

16. The bioptome of claim 11, wherein the insertion assembly further comprises a stop block disposed outside the outer tube and reciprocally movable along a surface of the outer tube.

17. The bioptome of claim 11, wherein the positioning assembly includes a magnetic navigation positioning sensor integrally formed with the pull rod, the magnetic navigation positioning sensor being disposed within an end of the inner tube proximate the hinge point.

18. The bioptome of claim 11, wherein the positioning assembly comprises a magnetic navigation positioning sensor and a sensor protective cap;

19. The biopsy forceps of claim 18, wherein the positioning assembly further includes a sensor protection sheath disposed through the inner tube, an end of the sensor protection sheath proximate the hinge point being coupled to the sensor protection cap.

20. The bioptome of claim 11, further comprising a handle assembly including a hand-held portion, a distal portion, and a proximal portion;

21. The bioptome of claim 20, wherein the handle assembly defines a channel portion therein in communication with the inner tube, and wherein an end of the proximal portion defines an interface portion in communication with the channel portion.