CN107233656B

Movatterモバイル変換

Info

Publication number: CN107233656B
Application number: CN201710585948.1A
Authority: CN
Inventors: 付亮辉; 沈碧峰
Original assignee: Enodar Medical Shanghai Co Ltd
Current assignee: Enodar Medical Shanghai Co Ltd
Priority date: 2017-07-18
Filing date: 2017-07-18
Publication date: 2022-12-02
Anticipated expiration: 2037-07-18
Also published as: CN107233656A

Abstract

The invention discloses a paranasal sinus sacculus catheter system, which particularly comprises a paranasal sinus guiding catheter component, wherein the paranasal sinus guiding catheter component comprises a paranasal sinus guiding catheter, a paranasal sinus control handle and a control structure, the paranasal sinus guiding catheter and the paranasal sinus control handle are integrated or integrally formed, the control structure is used for controlling the bending angle of the front end of the paranasal sinus guiding catheter, the front end of the paranasal sinus guiding catheter can be bent by an angle alpha to form a bending area, wherein the angle alpha is more than or equal to 0 degrees and less than 180 degrees, and the paranasal sinus control handle is provided with a side groove; the nasal sinus sacculus catheter body is provided with a sacculus, the tip end of the nasal sinus sacculus catheter body is provided with a flushing hole, and the center of the nasal sinus sacculus catheter body is provided with a guide wire channel; and a nasal sinus guide wire, wherein a guide wire marking belt is arranged on the outer surface of the nasal sinus guide wire, and the nasal sinus guide wire is positioned in the side groove and the guide wire channel and can move back and forth. The sinus sacculus catheter system has a simple structure, is convenient to operate, adapts to a sinus cavity structure, and is convenient for quickly and efficiently implementing the nasal endoscope minimally invasive surgery.

Description

Paranasal sinus sacculus pipe system

Technical Field

The invention relates to the field of medical instruments, in particular to a nasal sinus balloon catheter system.

Background

The nasal cavity and sinuses are located below the cranium, above the throat and mouth, and between the two eye sockets. Nasal and sinus lesions often spread to nearby tissues and cause a variety of complications. Nasosinusitis is usually detected by nasal examination, wherein purulent secretion exists in nasal passages or nasal clefts, and mucosa of middle turbinate and middle nasal passages is thickened or changed like polyps. Can be used for treating multiple sinusitis by replacing yin pressure, and for treating suppurative upper collar sinusitis by performing upper collar sinus puncture. For patients with mechanical obstruction factors such as nasal polyp, middle turbinate hypertrophy, nasal septum bending, adenoid hypertrophy and the like, inflammation is difficult to cure because ventilation and drainage of nasal sinuses are obstructed, and surgical treatment such as nasal polypectomy, turbinate resection, nasal septum correction, adenoid resection and the like can be adopted, and nasal endoscope minimally invasive surgery is commonly used at present.

For sinusitis patients with undesirable medication, the most common and effective treatment currently is "functional" endoscopic sinus patency, with the aim of reestablishing sinus ventilation and drainage through the natural sinus opening. At present, the common operation modes (such as FESS operation) are difficult to achieve the 'functional' sinus opening operation in the true sense, the injury of the mucosa of the sinus drainage channel in the operation, the formation of scar tissues after the operation, the bleeding which is difficult to control in the operation, the iatrogenic injury caused by the operation and the like are still inevitable.

Therefore, a nasal sinus balloon catheter system which is convenient to operate, adapts to a nasal sinus cavity structure and can quickly and efficiently perform nasal endoscope minimally invasive surgery is clinically lacked.

Disclosure of Invention

The invention aims to provide a nasal sinus sacculus catheter system for treating nasosinusitis, which is simple in structure and convenient to operate, can better adapt to a nasal sinus cavity structure, and is convenient for quickly and efficiently implementing nasal endoscope minimally invasive surgery.

The invention provides a paranasal sinus sacculus conduit system, which comprises a paranasal sinus guiding conduit assembly, a paranasal sinus guiding conduit assembly and a control structure, wherein the paranasal sinus guiding conduit assembly comprises a paranasal sinus guiding conduit, a paranasal sinus control handle and the control structure, the paranasal sinus guiding conduit and the paranasal sinus control handle are integrated or are integrally formed, and the control structure is used for controlling the bending angle of the front end of the paranasal sinus guiding conduit; the front end of the nasal sinus guiding catheter can be bent by an angle alpha to form a bending area, wherein the angle alpha is more than or equal to 0 degree and less than 180 degrees; the paranasal sinus control handle is positioned at the rear end of the paranasal sinus guide catheter, so that the paranasal sinus guide catheter can be controlled more freely, the paranasal sinus guide catheter component is stronger in firmness and is provided with a side groove, and the side groove is communicated with the paranasal sinus guide catheter; the nasal sinus sacculus conduit body enters the nasal sinus guiding conduit from the side groove and moves back and forth in the nasal sinus guiding conduit, the nasal sinus sacculus conduit body is provided with a sacculus, the tip end of the nasal sinus sacculus conduit body is provided with a flushing hole, so that the sacculus has the double functions of dilating and flushing the diseased nasal sinus, and the center of the nasal sinus sacculus conduit body is provided with a guide wire channel; and a nasal sinus guide wire, the surface of nasal sinus guide wire has seal wire mark area, the nasal sinus guide wire is located the side channel with the nasal sinus sacculus pipe body in the seal wire passageway, and round trip movement in the seal wire passageway, seal wire mark area both can show whether the nasal sinus guide wire stretches out nasal sinus sacculus pipe body front end can show again the nasal sinus guide wire stretches out the length of the sacculus pipe body to make things convenient for operator control the nasal sinus guide wire gets into the internal length of people.

In another preferred embodiment, the bending region of the front end of the sinus guide catheter is made of a flexible plastic tube or a flexible metal tube or a combination of the flexible plastic tube and the metal tube.

In another preferred embodiment, the posterior end of the sinus guide catheter is made of a rigid, inflexible material.

In another preferred embodiment, the sinus guide wire is light conductive.

In another preferred example, the bending region of the front end of the sinus guiding catheter is a metal tube, a cutting groove is arranged on the upper surface and/or the lower surface of the metal tube, the cross section of the cutting groove is gradually changed, the closer to the surface of the metal tube, the wider the cross section is, the closer to the central axis of the metal tube, the narrower the cross section is, and the cutting groove design can realize the bending function of the bending region.

In another preferred embodiment, each of the slots has a triangular cross-section.

The upper surface or the lower surface of the metal pipe is a cross section of the center plane of the metal pipe, and a metal pipe portion having a cross section larger than the cross section is referred to as an upper surface, and a metal pipe portion having a cross section larger than the cross section is referred to as a lower surface.

In another preferred example, the number of the cutting grooves on the upper surface or the lower surface is n, wherein n is more than or equal to 3 and less than or equal to 50.

In another preferred embodiment, the number of said cutting slots on the upper surface and the number of said cutting slots on the lower surface are equal.

In another preferred example, the upper and lower surfaces provided with the cutting grooves are symmetrical with respect to a center plane of the metal pipe.

In another preferred example, the depth of the cutting groove is 0.25-0.45 of the pipe diameter of the metal pipe.

In another preferred embodiment, the control structure comprises a pull wire and a control member, one end of the pull wire is fixedly connected to the bending region at the front end of the sinus guide catheter, and the other end of the pull wire is fixedly connected to the control member, so that a user can drive the pull wire to move forwards or backwards by operating the control member to control the bending region to bend.

In another preferred example, the head end of the traction wire is welded outside the cutting groove.

In another preferred embodiment, the control member is located at an anterior portion of the sinus control handle.

In another preferred example, a pull wire channel is provided in the tube wall of the sinus guide catheter and in front of the sinus control handle, and the pull wire is movable in the pull wire channel.

In another preferred example, the control structure is any one of the following structures: a control bend knob, a control bend push button, a rotating handle-type guide catheter, and a trigger-type guide catheter.

In another preferred example, the number of the traction wires is 1-2.

In another preferred example, the number of the traction wires is 1, and one end of the traction wire is fixedly connected to the upper surface or the lower surface of the bending region, which is provided with the cutting groove.

In another preferred embodiment, the number of the traction wires is 2, and one ends of the two traction wires are respectively connected to the upper surface and the lower surface of the bending area, which are provided with the cutting grooves.

In another preferred embodiment, the sinus guide catheter assembly is provided with a guidewire inlet.

In another preferred embodiment, the guide wire inlet is located at the rear end of the sinus control handle and is in communication with the side channel.

In another preferred embodiment, a guide wire locking switch for locking the sinus guide wire is arranged at the guide wire inlet of the sinus control handle.

In another preferred embodiment, one end of the nasal sinus guide wire is connected with the guide wire locking switch, and the other end of the nasal sinus guide wire passes through the side groove, enters the guide wire channel of the nasal sinus sacculus catheter body and extends out of the nasal sinus sacculus catheter body according to the requirement.

In another preferred embodiment, the guide wire locking switch is detachable.

In another preferred example, the guide wire locking switch is assembled at the tail part of the nasal sinus control handle in a threaded assembly mode.

In another preferred example, the guide wire locking switch is divided into a pulling state and a pushing state: when the guide wire locking switch is in a pulling state, the guide wire locking switch can lock the paranasal sinus guide wire; when the guide wire locking switch is in a push-insert state, the guide wire locking switch does not lock the sinus guide wire.

In another preferred embodiment, the guidewire marker band is in segments, each segment having a length of 1cm, and the spacing between adjacent segments is also 1cm, such that the length of the sinus guidewire into the balloon catheter body can be read directly through the guidewire marker band.

In another preferred embodiment, the marking band may be a heat shrinkable tube with a color different from the color of the guide wire itself, may be printed by laser, or may be made of a material such as fluorescent light or luminous light that can be observed in an environment with poor light.

In another preferred example sinus sacculus pipe body is equipped with the formation of image subassembly, the formation of image subassembly includes camera, optical cable and display screen, the camera is located the front end of sinus sacculus pipe body, the optical cable is located in the pipe wall of sinus sacculus pipe body, the display screen is located the rear portion of sinus sacculus pipe body, the camera electricity is connected in the one end of optical cable, through the optical cable will the real scene feedback that the camera was shot with the display screen that the optical cable other end is connected, through observing the situation that surgical instruments (especially sinus sacculus pipe body) actually face when advancing in the sinus intracavity can be more convenient to learn to the display screen.

In another preferred example, the flushing holes are in any one of the following shapes or a combination thereof: circular, oval, square, and rectangular.

In another preferred embodiment, the sinus control handle is an injection molded piece made of transparent material so as to facilitate observation of the operation of other devices in the inner cavity of the sinus control handle.

In another preferred example, the outer wall of the nasal sinus sacculus catheter body is provided with a catheter body mark belt.

In another preferred embodiment, the catheter body marker band is divided into two segments, a first catheter body marker band and a second catheter body marker band.

In another preferred example, when the sinus balloon catheter body enters the sinus guide catheter assembly, the sinus control handle is a transparent injection molding piece, so that the condition that the catheter body mark belt enters the sinus guide catheter can be observed, and particularly, when the first catheter body mark just enters the sinus guide catheter, the head end of the sinus balloon catheter body is indicated to reach the head end of the sinus guide catheter; when the second catheter body marker is fully advanced into the sinus guide catheter, indicating that the balloon portion of the sinus balloon catheter body has been advanced out of the sinus guide catheter, a balloon dilation may be performed.

It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.

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, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic view of a sinus balloon catheter body in accordance with one embodiment of the present invention.

Fig. 2a is an enlarged view of the tip portion a of the sinus balloon catheter body of fig. 1, wherein the irrigation holes are circular.

Fig. 2b is an enlarged view of tip portion a of the sinus balloon catheter body of fig. 1, wherein the irrigation holes are square.

Fig. 2c is an enlarged view of tip portion a of the sinus balloon catheter body of fig. 1, wherein the irrigation holes are oval.

FIG. 2d is an enlarged view of the tip portion A of the sinus balloon catheter body of FIG. 1, wherein the irrigation holes are rectangular.

Fig. 3 is an enlarged view of a portion B of the display screen of fig. 1.

FIG. 4a is a schematic view of a sinus guide wire according to an embodiment of the present invention.

FIG. 4b is a schematic assembled sinus guide wire and sinus balloon catheter body according to an embodiment of the present invention.

Fig. 4c is an enlarged view of the portion G of fig. 4 b.

FIG. 5 is a schematic view of a sinus guide catheter assembly having a control angle knob according to one embodiment of the present invention.

FIG. 6 is a schematic view of a sinus guide catheter assembly having a control angle push button according to one embodiment of the present invention.

Fig. 7a is a schematic view of a rotating handle sinus guide catheter in accordance with an example of the present invention.

Fig. 7b is an enlarged view of the portion C of fig. 7 a.

Fig. 7c is an enlarged view of a portion D of fig. 7 a.

FIG. 7d is a schematic view of a rotating handle sinus guide catheter with a handle according to an embodiment of the present invention.

Figure 8a is a schematic view of a trigger sinus guide catheter in accordance with one embodiment of the present invention.

Fig. 8b is an enlarged view of a portion E of fig. 8 a.

FIG. 9a is a schematic view of the front end of a sinus guide catheter in accordance with an embodiment of the present invention.

Fig. 9b is an enlarged view of portion F of fig. 9 a.

In the drawings, each symbol is as follows:

1-a sinus guide catheter;

2-sinus control handle;

3-a sinus balloon catheter body;

4-a camera;

5-a display screen;

6-sinus guide wire;

7-a guidewire marker band;

8-flushing the hole;

9-control bending knob;

10-controlling the bending push button;

11-a guide wire locking switch;

12-drawing wires;

i-bending at 0 degree;

II, bending at 60 degrees;

III-bending state at 105 degrees;

13-rotating handle type guide catheter;

14-a rotating handle;

15-rotation pin;

16-welding points;

17-a handle;

18-trigger type guide catheter;

The inventor of the invention develops a nasal sinus sacculus catheter system for the first time through extensive and intensive research and a large amount of screening, compared with the prior art, the front end of the nasal sinus guide catheter of the nasal sinus sacculus catheter system of the invention is bendable, and the nasal sinus guide catheter system can meet the requirements of any complex nasal sinus cavity; the sinus guide catheter and the sinus control handle are integrated into a whole to form the sinus guide catheter assembly, so that the sinus guide catheter assembly is firmer and more convenient to control; the balloon of the nasal sinus balloon catheter body has an expansion function, and the tip of the balloon is provided with a flushing hole, so that the nasal sinus balloon catheter body has a flushing function at the same time, and equipment is simplified; the sinus guide wire is provided with a guide wire marking belt, so that the extension length of the sinus guide wire is conveniently observed and controlled; and the paranasal sinus sacculus catheter system is provided with a camera and a display screen, so that the condition of an affected part can be observed conveniently, the operation is more accurate, and the like.

Term(s) for

As used herein, the term "pull wire" and the term "pull wire" are the same component and are used interchangeably.

The invention discloses a nasal sinus sacculus catheter system which has a specific structure. Typically, the sinus balloon catheter system of the present invention includes a sinus guide catheter assembly, a sinus balloon catheter body, and a sinus guide wire.

The sinus guide catheter assembly includes a frontsinus guide catheter 1, a rearsinus control handle 2, and a control structure. Thesinus guide catheter 1 and the sinus control handle 2 are integral, or formed integrally. The front end of the front paranasalsinus guiding catheter 1 can be made of a flexible plastic pipe or a flexible metal pipe or a combination of the flexible plastic pipe and the metal pipe and becomes a front end with an adjustable arbitrary angle bend; the rear end of the front portion is made of a hard, inflexible material. The rear paranasal sinus control handle 2 part can be an injection molding piece made of transparent materials, so that the operation of other instruments in the inner cavity of the rear paranasal sinus control handle is convenient to observe. The control structure can bend the front end of thesinus guide catheter 1. The paranasal sinus control handle 2 is provided with a side groove allowing the paranasal sinussacculus conduit body 3 to enter and a detachable guidewire locking switch 11.

As shown in FIGS. 9a and 9b, the bent region of thesinus guide catheter 1 is ametal tube 20, themetal tube 20 of the region may have a structure of two cut regions symmetrical about a center plane of symmetry thereof, a plurality ofcuts 23 are formed in each of the individual cut regions, and the cross section of thecut 23 in the shape of an inverted triangle may have a shape of which the section becomes smaller as it gets closer to the axis. Thesinus guide catheter 1 has acut 23 in a bending region, and a pull wire may be provided outside thecut 23, and a tip end of the pull wire is welded outside thecut 23, so that thecut 23 is bent when an external force such as a pull wire is applied. Such a bending effect can be achieved in the region of bothincisions 23 with respect to the center plane of symmetry.

The structure for achieving the bending control may be a control bending knob 9, a control bendingpush button 10, a rotary handletype guide catheter 13 guide catheter, and a triggertype guide catheter 18.

As shown in fig. 5, the bending control knob 9 is a structure with internal threads, and the bending control knob is rotated outside thesinus control handle 2, so that the rotation of the bending control knob drives the tail handle of theinternal traction wire 12 to displace, the tail handle of thetraction wire 12 drives thetraction wire 12 to displace, and thetraction wire 12 further drives the tip part to displace. Because one side of the tip part with the traction wire is pulled by thetraction wire 12, the other side without the traction wire is not pulled, and the tip is deformed and bent to the side with the traction wire. Wherein, I position is the state that the most advanced unbending ofsinus guide pipe 1 is 0 degrees in bending angle promptly, and II positions are the state that the most advanced bending angle ofsinus guide pipe 1 is 60 degrees, and III positions are the state that the most advanced bending angle ofsinus guide pipe 1 is 105 degrees.

As shown in fig. 6, the bendingcontrol button 10 is a structure having an inner groove therein, and the bending control button is pushed and pulled outside thesinus control handle 2, so that the pushing and pulling of the bending control button drives the tail handle of theinternal traction wire 12 to displace, the tail handle of thetraction wire 12 drives thetraction wire 12 to displace, and thetraction wire 12 further drives the tip portion to displace. Because the side of the tip part with traction is pulled by thetraction wire 12, the other side without the traction wire is not pulled, and the tip is deformed and bent to the side with the traction wire. Wherein, I position is the state that the most advanced unbending ofsinus guide pipe 1 is 0 degrees in bending angle promptly, and II positions are the state that the most advanced bending angle ofsinus guide pipe 1 is 60 degrees, and III positions are the state that the most advanced bending angle ofsinus guide pipe 1 is 105 degrees.

As shown in FIGS. 7a to 7c, the rotary handletype guide catheter 13 has arotary handle 14 at the rear of the sinus guide catheter, and the bending of the front end of the sinus guide catheter is controlled by therotary handle 14. In this structure, the sinus guide catheter is provided with two curved channels symmetrical about its central plane; each bending channel is provided with atraction wire 12, one end of thetraction wire 12 is welded with the front end of the nasal sinus guiding catheter through awelding point 16, and the other end of thetraction wire 12 is connected with arotating pin 15 in the inner cavity of arotating handle 14.

As shown in fig. 7d, the rotating handletype guide catheter 13 may be provided with ahandle 17 in a direction perpendicular to the sinus guide catheter so that the other hand controls the stabilization of the non-rotating part by grasping thehandle 17 while rotating and also controls the direction and movement of the entire instrument.

The rotary handletype guide catheter 13 can be rotated in both clockwise and counterclockwise directions: when rotating clockwise, one of therotating pins 15 tensions thepull wire 12 connected with the rotating pin, and then pulls the front part of the nasal sinus guiding catheter welded with thepull wire 12, and the otherrotating pin 15 loosens thepull wire 12 connected with the rotating pin, and then loosens the front part of the nasalsinus guiding catheter 1 welded with thepull wire 12; when rotated counterclockwise, the opposite effect to that described above is exhibited. Such a design may make it easier for the sinus guide catheter to bend in two opposite directions from 0 ° to 180 ° at any angle and to return to the unbent state after bending. For example, when rotating clockwise, the nasal sinus guide catheter bends to a certain side and bends to a required angle; when the nasal sinus guide catheter is rotated counterclockwise, the front portion of the nasal sinus guide catheter is slowly returned to the unbent state, and when the counterclockwise rotation is continued, the front portion of the nasal sinus guide catheter is bent to the other side to a desired angle. In addition, it is possible to mark curved angle scales on the shaft surface of the rotation handle 14 so as to quickly confirm the curved state of the leading end of the sinus guide catheter from these scales.

As shown in FIGS. 8a-8b, the trigger type guide catheter is a structure in which a trigger is provided at the rear of the sinus guide catheter, and the bending of the front end of the sinus guide catheter is controlled by atrigger handle 19. In this configuration, the sinus guide catheter has two symmetrical curved channels about its center plane of symmetry; each curved channel has apull wire 12, one end of thepull wire 12 is welded to the front of the guide catheter by aweld 16, and the other end of thepull wire 12 is attached to atrigger handle 19 that controls arotating handle 14.

The trigger-type guide catheter 18 may be pushed forward and pulled backward to move in two directions: when the trigger is moved forwards, theupper traction wire 12 is tensioned, so that the front end of the nasal sinus guide catheter welded with thetraction wire 12 is pulled, thelower traction wire 12 is loosened, and the front end of the nasal sinus guide catheter welded with thetraction wire 12 is also loosened; when the trigger is pulled backwards, thelower pull wire 12 is pulled tightly, and then the front end of the nasal sinus guide catheter welded with thepull wire 12 is pulled, theupper pull wire 12 is loosened, and the front end of the nasal sinus guide catheter welded with thepull wire 12 is also loosened. Such a design may make it easier for the sinus guide catheter to be bent at any angle from 0 ° to 180 ° in two opposite directions and to return to the unbent state after bending. For example, when the trigger is pushed and moved, the sinus guide catheter is bent to a certain side and is bent to a required angle; when the trigger is pulled backwards, the nasal sinus guiding catheter slowly returns to an unbent state, and when the trigger is pulled backwards continuously, the nasal sinus guiding catheter bends to the other side to a required angle. The curved angle scales may be marked on the surface of the housing of the trigger handle 19 so that the curved state of the leading end of the sinus guide catheter can be quickly confirmed from these scales.

The sinus guide catheter assembly is provided with a guide wire inlet for assisting thesinus guide wire 6 to enter, a guidewire locking switch 11 for locking thesinus guide wire 6 is arranged at the guide wire inlet, and the guidewire locking switch 11 is assembled at the tail part of the sinus control handle 2 in a threaded assembly mode. The guidewire locking switch 11 is in two states of drawing and pushing and inserting: when the nasal sinus guide wire is in a pulling state, the guidewire locking switch 11 can lock the nasalsinus guide wire 6, and when the nasal sinus guide wire is in a pushing and inserting state, the guidewire locking switch 11 does not lock the nasalsinus guide wire 6.

In the push-in state, thesinus guide wire 6 is advanced from the guidewire locking switch 11 of the guide wire inlet on the integratedsinus guide catheter 1, and enters the inner cavity of the sinusballoon catheter body 3 inside thesinus guide catheter 1, namely, the guide wire channel, until extending out of the front end of the sinusballoon catheter body 3, at this time, as shown in fig. 4b and 4c, the guidewire marking belt 7 can be flush with the tail part of the sinusballoon catheter body 3 without entering the sinusballoon catheter body 3; the guidewire locking switch 11 is pulled to lock thesinus guide wire 6; push away sealwire locking switch 11 and insert,sinus seal wire 6 is not locked, continue to push awaysinus seal wire 6, letsinus seal wire 6 at the inner chamber of sinussacculus pipe body 3, continue forward movement in the seal wire passageway promptly, and confirm the mark area on thesinus seal wire 6 and get into the length condition of sinussacculus pipe body 3, when the length of thesinus seal wire 6 of getting into sinussacculus pipe body 3 is enough, drawsinus seal wire 6 locking switch lockingsinus seal wire 6.

In particular, as shown in FIG. 4a, each of the small segments ofguidewire marker bands 7 may be 1cm in length and the spacing between each of the small segments ofguidewire marker bands 7 may also be 1cm in length, so that the length of thesinus guidewire 6 that enters the sinusballoon catheter body 3 can be read directly through the marker bands.

The mark belt can be a heat shrinkable tube with a color different from the color of the guide wire, can be printed by laser, and can also be made of fluorescent or luminous materials which can be observed in the environment with poor light, so that the extension length of the guide wire of the paranasal sinus can be observed and controlled under the condition that the light of an operating room is turned off during the operation. The sinus sacculus catheter system integrates the flushing function and the sinus sacculus expanding function, so that the affected sinus can be expanded and flushed by only one instrument, and equipment is simplified.

The flushing holes 8 may be circular (as shown in fig. 2 a), oval (as shown in fig. 2 c), square (as shown in fig. 2 b), rectangular (as shown in fig. 2 d), etc. When the length of the flushing holes 8 in the circumferential direction of the wall of the flushing pipe (i.e. the diameter of a circular flushing hole, the minor axis of an elliptical flushing hole, the side of a square flushing hole, the minor axis of a rectangular flushing hole) is constant, the area of the circle is the smallest, and the area of the ellipse, the square or the rectangle is larger than the area of the circle. In order to reduce the damage to the sinus cavity, the irrigation holes 8 are preferably formed in a shape having a large area, such as an ellipse, a square, or a rectangle, on the premise that the lengths of the irrigation holes in the circumferential direction of the tube wall of the irrigation tube (i.e., the diameter of the circular irrigation hole, the minor axis of the elliptical irrigation hole, the side of the square irrigation hole, and the short side of the rectangular irrigation hole) are fixed.

As shown in fig. 1-3, in the process that thesinus guide wire 6 and the sinusballoon catheter body 3 enter the diseased sinus cavity, thetip camera 4 of the sinusballoon catheter body 3 can be used to shoot the real-time conditions in the nasal cavity and the sinus, and the real-time conditions are displayed on thedisplay screen 5 connected to the rear part of the sinusballoon catheter body 3, and the operator can directly observe the internal conditions of the sinus on thedisplay screen 5. Therefore, the nasalsinus guide wire 6 and the nasal sinussacculus catheter body 3 can visually and conveniently enter a diseased sinus cavity.

The seal wire is withdrawn after the sacculus expansion is completed, the cleaning liquid is injected into the tail part of the nasal sinussacculus conduit body 3, the cleaning liquid washes the nasal sinus inner cavity through thewashing hole 8 on the tip end of the nasal sinussacculus conduit body 3, so that different instruments do not need to be put into to complete the sacculus expansion and washing, and the operation time is saved.

The work flow of the paranasal sinus balloon catheter system of the invention is as follows:

a) And judging the diseased paranasal sinus orifice and the diseased condition thereof under CT, and determining the required guide catheter angle.

b) The bending of the front end of the nasal sinus guide catheter is adjusted to a required angle through a control structure capable of controlling the bending of the front end of the nasal sinus guide catheter, and then the nasal sinus guide catheter component is placed in the nasal cavity, comes near the diseased nasal sinus ostium with the assistance of an endoscopic sinus and then enters the diseased nasal sinus ostium. If the advancing of the nasal sinus guiding catheter is not smooth in the process, the bending of the front end of the nasal sinus guiding catheter can be finely adjusted by the control knob until the front end enters the diseased nasal sinus orifice.

c) The sinus balloon catheter body is advanced outside the sinus guide catheter assembly along a side channel on the sinus guide catheter assembly into the lumen of the rear handle portion of the sinus guide catheter and finally into the lumen of the front guide catheter portion.

d) The sinus guide wire enters the lumen of the rear handle portion of the sinus guide catheter assembly from a guide wire locking switch at a guide wire inlet on the rear handle portion of the sinus guide catheter assembly and then into the sinus balloon catheter body lumen.

e) Under the push-plug state of the guide wire locking switch, the nasal sinus guide wire advances from the guide wire locking switch of the guide wire inlet on the handle part of the back part of the nasal sinus guide catheter assembly and enters the inner cavity of the nasal sinus sacculus catheter body in the nasal sinus guide catheter until the guide wire locking switch extends out of the front end of the nasal sinus sacculus catheter body, and at the moment, the guide wire marking belt can not enter the sacculus catheter body and is parallel and level with the tail part of the sacculus catheter body. Then the guide wire locking switch is pulled, and the nasal sinus guide wire is locked.

f) Then the nasal sinus guide wire and the nasal sinus sacculus catheter body enter the lesion sinus cavity. In the entering process, the real-time conditions in the nasal cavity and the nasal sinuses are shot by means of the tip camera of the nasal sinus sacculus conduit body and are displayed on the display screen at the rear part of the nasal sinus sacculus conduit body, so that an operator is assisted to quickly find out the diseased sinus orifice.

g) And pushing the guide wire locking switch to insert, wherein the nasal sinus guide wire is not locked, the guide wire is continuously pushed to enter a lesion sinus cavity through a lesion sinus orifice, and the length of the guide wire extending out of the balloon catheter body is confirmed through a mark zone on the guide wire. When the length of the guide wire extending out of the balloon catheter body is enough, the guide wire locking switch is pulled to lock the guide wire, the balloon catheter body is pushed forward to the lesion sinus ostium, and the marking belt of the paranasal sinus guide wire is ensured to not completely exit the balloon catheter body.

h) The saccule reaches the diseased paranasal sinus, the saccule is pressurized and expanded, and the diseased sinus opening is expanded by the saccule; the sacculus pressure release withdraws from the seal wire, then connects the washing liquid device and pours into the washing liquid into at sinus sacculus pipe body afterbody, and the washing liquid washes the sinus inner chamber through the most advanced washing hole of sinus sacculus pipe body. After the operation is finished, the whole set of the instrument is withdrawn from the body.

The main advantages of the invention include:

(a) The front end of the nasal sinus guide catheter is bendable, so that the nasal sinus guide catheter can meet the requirement of a complex nasal sinus cavity;

(b) The nasal sinus guide catheter and the nasal sinus control handle are integrated into a whole, so that the nasal sinus guide catheter is firmer and more convenient to control;

(c) The balloon of the nasal sinus balloon catheter body has an expansion function, and the tip of the balloon is provided with a flushing hole, so that the nasal sinus balloon catheter body has a flushing function at the same time, and equipment of a nasal sinus balloon catheter system is simplified;

(d) The sinus guide wire is provided with the guide wire marking belt, so that an operator can conveniently control the length of the sinus guide wire entering a human body, the marking belt can be made of fluorescent or noctilucent materials which can be observed in a poor light environment, and the extension length of the sinus guide wire can be observed and controlled under the condition that the light of an operating room is turned off during operation;

(e) The nasal sinus sacculus pipe system is provided with a camera and a display screen, so that the condition of the surgical instrument (especially the nasal sinus sacculus pipe body) which is actually faced when the surgical instrument advances in the nasal sinus cavity can be known conveniently.

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, the drawings are schematic and, thus, the apparatus and devices of the present invention are not limited by the size or scale of the schematic.

It is to be noted that in the claims and the description of the present patent, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, 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, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element.

Examples

As shown in fig. 1-9b, the sinus balloon catheter system of the present embodiment includes a sinus guide catheter assembly, a sinusballoon catheter body 3, and asinus guide wire 6. Wherein, the nasal sinus guide catheter assembly comprises a nasalsinus guide catheter 1, a nasal sinus control handle 2 and a control structure. The front end of thesinus guide catheter 1 forms a bending area by controlling the bending angle alpha of the structure, wherein alpha is more than or equal to 0 degree and less than 180 degrees, and the sinus guide catheter can meet the requirement of a complex sinus cavity in the using process. Thesinus guide catheter 1 is made of a soft bendable metal tube at the front end of the bending region and a hard, inflexible material at the rear end. Theupper surface 21 and thelower surface 22 of the frontend metal pipe 20 are respectively provided with a cuttinggroove 23, the depth of the cuttinggroove 23 is 0.4 of the pipe diameter of themetal pipe 20, the cuttinggroove 23 area of theupper surface 21 and the cuttinggroove 23 area of thelower surface 22 are symmetrical about the central plane of themetal pipe 20, the number of the cuttinggrooves 23 on theupper surface 21 or thelower surface 22 is 26, the cross section of theshape cutting groove 23 can be the shape that the closer to the surface of themetal pipe 20, the wider the cross section and the closer to the central axis of themetal pipe 20, the narrower the cross section. Thecut 23 of themetal tube 20 is designed to perform the bending function of the bending area.

The control structure includespull wire 12 and control, the quantity ofpull wire 12 is two, and the one end of twopull wires 12 is fixed connection respectively in theupper surface 21 and thelower surface 22 that are equipped with grooving 23 of bending region, and the welding is outside grooving 23, other end fixed connection is in the anterior control ofsinus control handle 2, in addition, be equipped withpull wire 12 passageway in the pipe wall ofsinus guide pipe 1 and the anterior ofsinus control handle 2, pullwire 12 can move in the pull wire passageway, the user drives pullwire 12 through control operation control and moves forward or backward, and then the bending of control bending region.

Sinus brake valve handle 2 is located the rear end ofsinus guide pipe 1, is integrative withsinus guide pipe 1, and sinus brake valve handle 2 is equipped with the side groove, and side groove andsinus guide pipe 1 are linked together, and the integral type design makes the control tosinus guide pipe 1 more freely, and the fastness is stronger. The sinus control handle 2 is an injection molding piece made of transparent material so as to facilitate observation of the operation of other instruments in the inner cavity of thesinus control handle 2.

The nasal sinussacculus pipe body 3 enters into nasalsinus guide pipe 1 from the side groove to round trip movement in nasal sinus sacculus guide pipe has seted up flushinghole 8 on the pointed end of nasal sinussacculus pipe body 3, makes the sacculus have the dual function of expansion and flushing the nasal sinus of pathological change, simplifies equipment. Theflushing hole 8 of the present embodiment is rectangular in shape.

Sinus guide catheter subassembly is equipped with the seal wire entry, there is sealwire mark area 7 onsinus seal wire 6's surface,sinus seal wire 6 is located the seal wire passageway of side channel and sinussacculus pipe body 3, and round trip movement in seal wire passageway, sealwire mark area 7 both can show whethersinus seal wire 6 stretches out the 3 front ends of sinus sacculus pipe body, can show the length thatsinus seal wire 6 stretches out the sacculus pipe body again, in order to make things convenient for operator controlsinus seal wire 6 to get into the internal length of people.

In addition, a guidewire locking switch 11 used for locking thesinus guide wire 6 is arranged at the guide wire inlet of thesinus control handle 2, one end of thesinus guide wire 6 is connected with the guidewire locking switch 11, and the other end of thesinus guide wire 6 penetrates through the side groove to enter the guide wire channel and extend out of the sinussacculus catheter body 3 according to the requirement. The guidewire locking switch 11 is detachably assembled at the tail part of the nasal sinus control handle 2 in a thread assembling mode. The guidewire locking switch 11 is divided into two states of drawing and pushing and inserting: when the guidewire locking switch 11 is in a drawing state, the guidewire locking switch 11 can lock thesinus guide wire 6; when the guidewire locking switch 11 is in the push-insert state, the guidewire locking switch 11 does not lock thesinus guide wire 6.

In addition, be equipped withcamera 4 at sinussacculus pipe body 3, optical cable anddisplay screen 5,camera 4 is located the front end of sinussacculus pipe body 3, the optical cable is arranged in sinussacculus pipe body 3's pipe wall,display screen 5 is located sinussacculus pipe body 3's rear portion,camera 4 electricity is connected in the one end of optical cable, the outdoor scene feedback of takingcamera 4 through the optical cable is connected with thedisplay screen 5 that the optical cable other end is electric mutually, through observing thatdisplay screen 5 can be more convenient learn the situation that surgical instruments (especially sinus sacculus pipe body) actually face when advancing in the sinus intracavity.

All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.

Claims

1. A sinus balloon catheter system, the system comprising

A sinus guide catheter assembly including a sinus guide catheter, a sinus control handle, and a control structure, and the sinus guide catheter and the sinus control handle being integral with the control structure for controlling a bending angle of a front end of the sinus guide catheter; the front end of the nasal sinus guiding catheter can be bent by an angle alpha to form a bending area, wherein the angle alpha is more than or equal to 0 degree and less than 180 degrees; the nasal sinus control handle is positioned at the rear end of the nasal sinus guide catheter, and is provided with a side groove which is communicated with the nasal sinus guide catheter;

the nasal sinus sacculus pipe body enters the nasal sinus guiding pipe from the side groove and moves back and forth in the nasal sinus guiding pipe, the nasal sinus sacculus pipe body is provided with a sacculus, the tip end of the nasal sinus sacculus pipe body is provided with a flushing hole, and the center of the nasal sinus sacculus pipe body is provided with a guide wire channel; and

a sinus guide wire having a guide wire marker band on an outer surface thereof, the sinus guide wire being positioned within the side channel and the guide wire channel of the sinus balloon catheter body and moving back and forth within the guide wire channel;

the bending area at the front end of the paranasal sinus guide catheter is a metal pipe, and cutting grooves are formed in the upper surface and the lower surface of the metal pipe;

the control structure comprises a traction wire and a control piece, one end of the traction wire is fixedly connected to the bending area at the front end of the nasal sinus guiding catheter, and the other end of the traction wire is fixedly connected to the control piece;

the control structure is a rotating handle type guide catheter;

wherein the rotary handle type guide catheter has a rotary handle at a rear portion of the sinus guide catheter, and the bending of a front end of the sinus guide catheter is controlled by the rotary handle, and the sinus guide catheter is provided with two bending channels symmetrical about a central plane thereof; the traction wire is arranged in each bent channel, one end of the traction wire is welded with the front end of the nasal sinus guide catheter through a welding spot, and the other end of the traction wire is connected with a rotating pin in the inner cavity of the rotating handle;

the rotating handle guide catheter rotates clockwise or counterclockwise about its central axis: when rotating clockwise, one of the rotating pins tensions the traction wire connected with the rotating pin, so that the front part of the nasal sinus guiding catheter welded with the traction wire is pulled, the other rotating pin loosens the traction wire connected with the rotating pin, so that the front part of the nasal sinus guiding catheter welded with the traction wire is loosened, and the nasal sinus guiding catheter bends towards one side; when the nasal sinus guiding catheter rotates anticlockwise, one rotating pin loosens the traction wire connected with the rotating pin and further loosens the front part of the nasal sinus guiding catheter welded with the traction wire, the other rotating pin tightens the traction wire connected with the rotating pin and further pulls the front part of the nasal sinus guiding catheter welded with the traction wire, and the nasal sinus guiding catheter bends towards the other side;

the paranasal sinus sacculus pipe body is provided with an imaging component, the imaging component comprises a camera, an optical cable and a display screen, the camera is located at the front end of the paranasal sinus sacculus pipe body, the optical cable is located in the pipe wall of the paranasal sinus sacculus pipe body, the display screen is located at the rear part of the paranasal sinus sacculus pipe body, the camera is electrically connected to one end of the optical cable, and a real scene shot by the camera is fed back to the display screen connected with the other end of the optical cable through the optical cable;

the paranasal sinus control handle is an injection molding piece made of transparent materials.

2. A sinus balloon catheter system according to claim 1 wherein the cross-section of the notch is gradual and the wider the cross-section the closer to the surface of the metal tube, the narrower the cross-section the closer to the central axis of the metal tube.

3. The sinus balloon catheter system of claim 2, wherein each of the slots is triangular in cross-section.

4. The sinus balloon catheter system of claim 1, wherein the rotating handle guide catheter is provided with a handle in a direction perpendicular to the sinus guide catheter, whereby the handle controls the stabilization of the non-rotating portion and controls the direction and movement of the entire instrument.

5. The sinus balloon catheter system of claim 1, wherein a curved angle scale is marked on the shaft surface of the rotation handle.

6. The sinus balloon catheter system of claim 1, wherein a guidewire locking switch for locking the sinus guidewire is provided at a guidewire entrance of the sinus control handle.

7. The sinus balloon catheter system of claim 6, wherein the guidewire locking switch is detachable.

8. The sinus balloon catheter system of claim 1, wherein the irrigation holes are any one or a combination of the following shapes: circular, oval, square, and rectangular.