Disclosure of Invention
Based on this, it is necessary to provide an incision knife against the problem of difficult intubation in ERCP surgery.
In one aspect, the present application provides a lancing knife comprising:
the outer peripheral surface of the cutter tube assembly is provided with an opening;
the cutter wire penetrates through the cutter tube assembly and is connected with the distal end of the cutter tube assembly, and part of the cutter wire is exposed out of the cutter tube assembly through the opening to form a cutting edge for cutting; the method comprises the steps of,
the expansion sleeve is arranged at the far end of the knife tube assembly, and the outer circumferential surface of the expansion sleeve is provided with an expanding structure.
The technical scheme of the application is further described below:
in one embodiment, the expanding structure comprises a thread structure arranged on the outer peripheral surface of the expanding sleeve; or, the expanding structure comprises a plurality of annular bulges which are sequentially arranged along the direction from the distal end to the proximal end of the expanding sleeve, and the diameters of the annular bulges are sequentially increased along the direction from the distal end to the proximal end of the expanding sleeve.
In one embodiment, the expansion sleeve further comprises a sleeve body sleeved at the distal end of the knife tube assembly, and the expanding structure is arranged along the circumferential direction of the sleeve body.
In one embodiment, the distracting structure has an expanded state in which the distracting structure expands in a radial direction of the sleeve body and a contracted state; in the contracted state, the expanding structure contracts in the radial direction of the sleeve body.
In one embodiment, the stretching structure comprises a body sleeved on the sleeve body and a reversible part which is connected to the body in a reversible manner, in the unfolded state, the reversible part protrudes out of the outer peripheral surface of the body along the radial direction of the body, and in the contracted state, the reversible part is attached to the outer peripheral surface of the sleeve body or the outer peripheral surface of the body.
In one embodiment, the incision knife further comprises a sheath axially movably sleeved outside the knife tube assembly, and when the sheath moves distally relative to the knife tube assembly to be sleeved outside the expansion sleeve, the sheath drives the reversible portion to switch from the expanded state to the contracted state.
In one embodiment, one of the body and the invertible portion includes an electromagnetic member, and the other includes a magnetically attractable member, the electromagnetic member being configured to attract the magnetically attractable member to bring the invertible portion into a contracted state, or the electromagnetic member releasing the magnetically attractable member to bring the invertible portion into an expanded state.
In one embodiment, the cutter tube assembly comprises a multi-cavity tube and a tip seat connected to the distal end of the multi-cavity tube, the multi-cavity tube is provided with a first cavity, the opening is formed in the outer peripheral surface of the multi-cavity tube and is communicated with the first cavity, and the cutter wire is arranged in the first cavity in a penetrating manner and is connected with the tip seat.
In one embodiment, the incision knife further comprises a camera and a wire harness electrically connected with the camera, the multi-cavity tube is further provided with a second cavity, the camera is arranged on the end socket, and the wire harness penetrates through the second cavity.
In one embodiment, the tip seat is cone frustum shaped, the expansion sleeve comprises an expansion part sleeved on the tip seat and a threaded part sleeved on the distal end of the multi-cavity tube, the expansion part is cone frustum shaped, and the taper of the expansion part is matched with the taper of the tip seat.
In one embodiment, the incision knife further comprises a handle and a finger ring axially movably disposed on the handle, the handle is connected to the proximal end of the multilumen tubing, the finger ring is connected to the proximal end of the knife wire, and the finger ring is used for pulling the knife wire.
In one embodiment, the multi-lumen tube is further provided with a first instrument channel penetrating through two ends of the multi-lumen tube, the tip seat is provided with a second instrument channel penetrating through two ends of the multi-lumen tube, and the first instrument channel is communicated with the second instrument channel.
The cutter wire is arranged in the cutter tube assembly in a penetrating way, and part of the cutter wire is exposed out of the cutter tube assembly through an opening on the outer peripheral surface of the cutter tube assembly to form a cutting edge, so that the cutting edge of the cutter wire can cut the papillary sphincter of the duodenum by pulling the proximal end of the cutter wire. And the expansion sleeve is sleeved at the distal end of the knife tube assembly, and the expansion structure is arranged on the outer circumferential surface of the expansion sleeve, so that the expansion structure on the outer circumferential side of the expansion sleeve can expand the narrow section of the sphincter channel or the bile duct channel when passing through the narrow section of the sphincter channel or the bile duct channel, the narrow section of the sphincter channel or the bile duct channel is expanded, and the knife tube assembly after the expansion sleeve can smoothly pass through. And compare in traditional adopting earlier the cutting of incision sword and adopting again and use gasbag knife tube or expansion bougie to carry out the operation flow of narrow section expansion, the incision sword of this application can accomplish the process of cutting and expansion simultaneously, has reduced the number of times of surgical instruments and switching instrument to optimize the operation step, reduced the operation degree of difficulty, reduced operation cost and operation time, avoided simultaneously when switching instrument the guide wire shift lead to need carry out the problem of intubate again, and then reduced the risk of pancreatitis and other complications that the repetition intubate leads to.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In this embodiment, "distal" refers to the end that is distal from the operator and "proximal" refers to the end that is proximal to the operator. "axial" refers to a direction along the axis of the whole or part; "circumferential" refers to a direction of rotation about an "axial" direction. "radial" refers to a direction perpendicular to the axis of the body or component.
An embodiment of the present application provides an incision knife for incising the papillary sphincter of the duodenum during ERCP surgery. It is noted that the lancets of the present application are also applicable to other procedures. In particular, referring to fig. 1 to 3, an incision knife according to an embodiment includes a knife tube assembly 10, and an opening is formed in an outer circumferential surface of the knife tube assembly 10. The cutter wire 20 is penetrated through the cutter tube assembly 10, and the distal end of the cutter wire 20 is connected with the distal end of the cutter tube assembly 10, and a portion of the cutter wire 20 is exposed outside the cutter tube assembly 10 through an opening to form a cutting edge for cutting. The expansion sleeve 30 is fixedly sleeved on the distal end of the cutter tube assembly 10, and an expansion structure is arranged on the outer circumferential surface of the expansion sleeve 30 and used for expanding the nipple sphincter of the duodenum and the narrow section of the bile duct channel, and preferably comprises a thread structure 32. Preferably, the expansion sleeve 30 further comprises a sleeve body 31, the sleeve body 31 is sleeved on the distal end of the cutter tube assembly 10, and the thread structure 32 is arranged along the circumferential direction of the sleeve body 21.
Further, in order to break through the papillary sphincter of the duodenum and the narrow section of the bile duct channel, the conventional incision knife usually only makes the head end part in front of the blade as small as possible to ensure smooth intubation. However, the small head end portion is not rigid enough, it is difficult to open the sphincter or the stricture, and it is also easy to stab human tissue.
The incision knife according to the embodiment of the present application is configured such that the incision wire 20 is inserted into the cutter tube assembly 10, and a portion of the incision wire 20 is exposed to the cutter tube assembly 10 through the opening of the outer circumferential surface of the cutter tube assembly 10 to form a cutting edge, so that by pulling the proximal end of the incision wire 20, the cutting edge of the incision wire 20 can be pulled to incise the papillary sphincter of the duodenum. And through the distal end cover of knife tube assembly 10 establishes the expansion cover 30 to set up screw thread structure 32 at the outer peripheral face of expansion cover 30, thereby when passing through the narrow section of sphincter passageway or bile duct passageway, can drive expansion cover 30 rotation through rotating knife tube assembly 10, when expansion cover 30 rotates, the screw thread structure 32 of expansion cover 30 periphery side can cooperate with human tissue wall in order to exert an axial force to expansion cover 30, make expansion cover 30 can go deep into gradually and prop open the narrow section of sphincter passageway or bile duct passageway, reach the narrow section of expansion sphincter passageway or bile duct passageway, the knife tube assembly 10 after the expansion cover 30 is convenient for pass through smoothly. And compare in traditional adopting earlier the cutting of incision sword and adopting again and use gasbag knife tube or expansion bougie to carry out the operation flow of narrow section expansion, the incision sword of this application can accomplish the process of cutting and expansion simultaneously, has reduced the number of times of surgical instruments and switching instrument to optimize the operation step, reduced the operation degree of difficulty, reduced operation cost and operation time, avoided simultaneously when switching instrument the guide wire shift lead to need carry out the problem of intubate again, and then reduced the risk of pancreatitis and other complications that the repetition intubate leads to.
It should be noted that, in another embodiment, the expanding structure may also include a plurality of annular protrusions sequentially disposed along the distal end to the proximal end of the expanding sleeve 30, and the diameters of the annular protrusions sequentially increase along the distal end to the proximal end of the expanding sleeve 30, so that when the incision knife passes through the narrow section of the sphincter channel or the bile duct channel, the plurality of annular protrusions sequentially increase gradually to expand the narrow section of the sphincter channel or the bile duct channel, ensuring that the incision knife passes through the narrow section of the sphincter channel or the bile duct channel smoothly, and solving the difficult problem of intubation.
Referring to fig. 4 and 5, in the present embodiment, the cutter tube assembly 10 includes a multi-lumen tube 11 and a tip seat 12 connected to a distal end of the multi-lumen tube 11, wherein the multi-lumen tube 11 is provided with a first lumen 101 penetrating through both ends thereof, the cutter wire 20 is inserted into the first lumen 101, and a distal end of the cutter wire 20 is fixedly connected to the tip seat 12. Further, the multi-lumen tube 11 and the tip seat 12 may be a nested connection, a threaded connection, an adhesive connection, or the like. Of course, in other embodiments, the multi-lumen tube 11 may also be integrally formed with the tip seat 12.
Optionally, referring to fig. 1, the multi-lumen tube 11 includes a straight tube section 111 and a curved section 112 connecting the straight tube section 111 and the tip seat 12, the opening is provided in the curved section 112, by providing the opening in the curved section 112, the cutter wire 20 can be exposed outside the cutter tube assembly 10 when passing through the curved section 112, and the curved section 112 can better adapt to a curved sphincter channel or bile duct channel, so that the incision is easier to pass through about the muscle channel or bile duct channel.
Further, the incision knife further comprises a handle 41 and a finger ring 42 which is axially movably arranged on the handle 41, the handle 41 is connected with the proximal end of the knife tube assembly 10, the finger ring 42 is connected with the proximal end of the knife wire 20, the finger ring 42 is used for pulling the knife wire 20 so as to control the bending degree of the bending section 112, and the knife wire 20 can be driven when the finger ring 42 is pulled to drive the bending section 112 to bend, so that the papillary sphincter of the duodenum can be cut and incised through the cutting edge of the knife wire 20. Preferably, the material of the multi-lumen tube 11 is a polymer compound material with moderate hardness and high rebound degree, such as PTFE (Poly tetra fluoroethylene ) and the like, so that the multi-lumen tube 11 can be controlled to bend by pulling the cutter wire 20 and has better torsion control performance, and the handle 41 can be rotated to effectively drive the whole multi-lumen tube 11 to rotate, thereby adjusting the orientation of the cutting edge of the cutter wire 20.
Referring to fig. 2 and fig. 6 and 7, the tip seat 12 is in the shape of a truncated cone, i.e. the diameter of the tip seat 12 gradually decreases in a direction away from the multi-lumen tube 11. The end socket 12 is sleeved on the end socket 12 and the distal end of the multi-cavity tube 11 at the same time, further, the expansion sleeve 30 comprises an expansion part 312 sleeved on the end socket 12 and a threaded part 311 sleeved on the distal end of the multi-cavity tube 11, the expansion part 312 is cone-shaped, namely, the diameter of the end socket 12 is gradually reduced towards the direction far away from the multi-cavity tube 11, and the taper of the expansion part 312 is matched with the taper of the end socket 12, so that the expansion part 312 of the expansion sleeve 30 is sleeved on the end socket 12 and can be tightly attached to the end socket 12, the end socket 12 provides rigid support for the expansion part 312, and the expansion sleeve 30 can break through the narrow section of the sphincter channel or the bile duct channel more easily by matching with the cone-shaped shapes of the upper end socket 12 and the expansion part 312.
Optionally, referring to fig. 4, the cutting knife further includes a camera (not shown) and a wire harness 51 electrically connected to the camera, the multi-cavity tube 11 is further provided with a second cavity 102, the camera is disposed on the tip seat 12, preferably, the tip seat 12 is provided with a first mounting hole 122 penetrating through a distal end of the tip seat 12 and communicating with the second cavity 102, and the camera is disposed in the first mounting hole 122. The wire harness 51 is threaded into the second cavity 102. The camera is used for obtaining the internal image of patient, and pencil 51 is used for supplying power and data transmission for the camera, and further, the proximal end of pencil 51 is used for being connected to the host computer to can show the image that the camera obtained through the display screen of host computer, and then provide the operation field of vision for the doctor. Preferably, the visual device further comprises a light source (not shown) disposed in the header base 12 and electrically connected to the wire harness 51. Alternatively, the camera may be a CMOS image sensor, a CCD camera, and the light source may be an LED, an optical fiber, or the like.
Through setting up the camera in end mount 12 to can send into the patient with the camera through knife tube assembly 10, in the ERCP art, the camera can acquire the image of direct-view duodenal papilla, thereby replace traditional X-ray perspective's plane side view image, reduced the wire or cut instrument and seek and get into the degree of difficulty of nipple, more be favorable to assisting the doctor to carry out the operation. And no radiation is generated, so that the interference of doctors and patients on the ERCP operation is further reduced, and the popularization of the ERCP operation and the service of more adaptation groups are facilitated. Meanwhile, after perspective is not needed, ERCP operation is not needed to be carried out in a specific ERCP room, and the ERCP operation can be carried out in a common diagnosis and treatment room, so that the waiting time of a patient is greatly reduced, and the mobility of a sickbed of a hospital is improved.
With continued reference to fig. 4 and 5, the multi-lumen tube 11 is further provided with a first instrument channel 103 extending through both ends thereof, the tip seat 12 is provided with a second instrument channel 121 extending through both ends thereof, and the first instrument channel 103 is in communication with the second instrument channel 121, preferably the first instrument channel 103 is disposed concentrically with the second instrument channel 121. The surgical instrument may be passed through the visualization device via the first instrument channel 103 and the second instrument channel 121 and operated with the assistance of the field of view provided by the visualization device. In particular, surgical instruments include, but are not limited to, one or more of a guidewire, biopsy forceps, laser fiber.
Further, referring to fig. 3, the distal end of the expansion sleeve 30 is provided with an avoidance opening 33, that is, the distal end of the bellows 30 is in an open structure, and the avoidance opening 33 is communicated with the second instrument channel 121 and the first mounting hole 122, so that the surgical instrument penetrating out of the cutter tube assembly 10 can be ensured to penetrate out of the distal end of the expansion sleeve, and the distal end of the expansion sleeve 30 is prevented from shielding the view of the camera.
Alternatively, in one of the embodiments, the thread structure 32 has an expanded state in which the thread structure 32 expands in the radial direction of the sleeve 31 to form an external thread, and a contracted state. Under the contracted state, the thread structure 32 is contracted along the radial direction of the sleeve body 31, so that when the narrow section of the sphincter channel or the bile duct channel passes through, the thread structure 32 is configured to be in an expanded state, the thread structure 32 can form external threads, and then the expansion sleeve 30 can be driven to rotate by rotating the cutter tube assembly 10, so that the expansion sleeve 30 is assisted to pass through and prop open the narrow section of the sphincter channel or the bile duct channel, the narrow section of the sphincter channel or the bile duct channel is expanded, and the cutter tube assembly 10 after the expansion sleeve 30 can pass through smoothly. When the incision is completed, the thread structure 32 is configured to be in a contracted state, so that the thread structure 32 is radially contracted, the diameter of the expansion sleeve 30 is reduced, a doctor can directly withdraw the incision from the narrow section of the sphincter channel or the bile duct channel without reversely rotating the handle 41 or the cutter tube assembly 10, the problem that the incision is slowly withdrawn and easily repeatedly contacted with the channel wall due to the resistance of the thread structure 32 to the narrow section tissue when the incision reversely rotates is avoided, the operation experience of a patient with low tolerance is improved, and the operation speed is accelerated.
Alternatively, referring to fig. 8 to 11, in one embodiment, the screw structure 32 includes a body 321 sleeved on the sleeve 31 and a reversible portion 322 rotatably connected to the body 321, in the unfolded state, the reversible portion 322 protrudes from the outer peripheral surface of the body 321 along the radial direction of the body 321, and in the contracted state, the reversible portion 322 is attached to the outer peripheral surface of the sleeve 31 or the outer peripheral surface of the body 321, so that the screw structure 32 can be switched between the unfolded state and the contracted state by driving the reversible portion 322 to turn in different directions.
In particular, referring to fig. 8 and 9, in one embodiment, the cutting blade further includes a sheath 60, the sheath 60 being axially movably sleeved outside the blade tube assembly 10. Specifically, when the incision knife enters a narrow section or performs an incision operation, the thread structure 32 is in an expanded state, the sheath 60 is sleeved outside the straight tube section 111 of the multi-lumen tube 11, so that the covering of the thread structure 32 and the cutting edge of the knife wire 20 is avoided, when the incision knife needs to be withdrawn, the sheath 60 is driven to move distally relative to the knife tube assembly 10 to be sleeved outside the expansion sleeve 30, at this time, the sheath 60 abuts against the reversible part 322 and drives the reversible part 322 to be turned over until the reversible part is tightly attached to the outer peripheral surface of the sleeve body 31, so that the thread structure 32 enters a contracted state, the diameter of the expansion sleeve 30 is reduced, and the incision knife is conveniently withdrawn. At the next operation, the reversible portion 322 of the threaded structure 32 is simply shifted proximally before entry of the incision knife to allow the threaded structure 32 to be re-deployed. Preferably, in the present embodiment, the material of the thread structure 32 is silica gel or latex, and the thread structure 32 forms external threads in the unfolded state by predetermined properties.
Referring to fig. 10 and 11, in another embodiment, one of the body 321 and the invertible portion includes an electromagnetic member, and the other includes a magnetically attractable member, and the electromagnetic member is configured to attract the magnetically attractable member to bring the invertible portion 322 into the contracted state, or release the magnetically attractable member to bring the invertible portion 322 into the expanded state. For example, the body 321 is an electromagnetic belt, which is spirally wound around the casing 31, and the electromagnetic band-pass electric energy generates a magnetic field. The reversible part 322 comprises a magnet of an inner layer and an elastic outer layer which is coated outside the magnet and is in reversible connection with the electromagnetic tape, the elastic outer layer can be made of silica gel or latex, when the incision knife enters a narrow section or performs incision operation, the electromagnetic tape is powered off, no magnetic field is generated by the electromagnetic tape at this time, and the reversible part 322 can be maintained in an unfolded state under the action of the elasticity of the elastic outer layer. When the incision knife needs to be withdrawn, the electromagnetic belt is electrified, so that the electromagnetic belt generates a magnetic field and adsorbs the reversible part 322, the reversible part 322 is turned over to be clung to the outer peripheral surface of the electromagnetic belt, and the thread structure 32 enters a contracted state, so that the diameter of the expansion sleeve 30 is reduced, and the incision knife is convenient to withdraw. After the cutting knife is completely withdrawn, the electromagnetic belt is powered off again, so that the electromagnetic belt releases the reversible part 322, and the reversible part 322 can be restored to the unfolded state to form external threads.
It should be noted that, instead of the above two modes of turning the thread structure 32 to switch between the deployed state and the contracted state, there may be other modes, for example, the thread structure 32 may be an inflatable or fluid-filled air bag having a thread shape, and the inflatable or fluid-filled air bag is configured to enable the air bag to be deployed or contracted, so as to switch the thread structure 32 between the deployed state and the contracted state.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.