CN109602484B

CN109602484B - Reducing sleeve device and puncture outfit

Info

Publication number: CN109602484B
Application number: CN201811611526.8A
Authority: CN
Inventors: 朱莫恕
Original assignee: 5r Med Technology Chengdu Co ltd
Current assignee: 5r Med Technology Chengdu Co ltd
Priority date: 2017-06-03
Filing date: 2017-06-03
Publication date: 2023-06-23
Anticipated expiration: 2037-06-03
Also published as: WO2018218991A1; CN109602484A; CN107049438A; CN107049438B

Abstract

The invention relates to a reducer casing device and a puncture outfit, which comprises a reducer casing assembly, a lower cover plate and a lower shell, wherein the reducer casing assembly is clamped and fixed by the lower cover plate and the lower shell, the reducer casing assembly comprises at least two half approximately symmetrical movable casings and fixed casings and film casings wrapping the movable casings and the fixed casings, and the movable casings, the fixed casings and the film casings form a hollow channel for accommodating the ingress and egress of surgical instruments; the movable sleeve is driven by the reducing driving mechanism to do linear motion along the transverse axis, which is close to or far from the longitudinal axis.

Description

Reducing sleeve device and puncture outfit

The application is named as: a reducing sleeve device and a puncture outfit, the application date is: day 03 of 2017, month 06, application number: division of the invention patent application of 2017104102239.

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a puncture outfit structure.

Background

A puncture device is a surgical instrument used in minimally invasive surgery (especially hard endoscopic surgery) to create an artificial channel into a body cavity. Typically consisting of a cannula assembly and a needle. The clinical general use mode is as follows: a small incision is made in the patient's skin and the needle is passed through the cannula assembly, and then passed through the abdominal wall together through the skin opening and into the body cavity. Once the body cavity is accessed, the needle is removed, leaving the cannula assembly as a passageway for instruments to enter and exit the body cavity.

In hard laparoscopic surgery, particularly laparoscopic surgery, a pneumoperitoneum machine is generally used to continuously perfuse the abdominal cavity of a patient with a gas (e.g., carbon dioxide gas) and maintain a stable gas pressure (about 13-15 mmHg) to obtain a sufficient surgical operation space. The cannula assembly is typically comprised of a cannula, a housing, a sealing membrane (also known as an instrument seal) and a zero seal (also known as an auto seal). The cannula penetrates from outside the body cavity into the body cavity as a passageway for instruments to enter and exit the body cavity. The housing connects the sleeve, zero seal and sealing membrane into a sealed system. The zero seal typically does not provide a seal to the inserted instrument, but automatically closes and forms a seal when the instrument is removed. The sealing membrane grips the instrument and forms a seal when the instrument is inserted.

In a typical cholecystectomy, 4 puncture passages are usually created in the patient's abdominal wall, namely 2 small diameter cannula assemblies (typically 5 mm) and 2 large diameter cannula assemblies (typically 10 mm). Instruments that are typically accessed into the patient via a small inner diameter cannula assembly perform only a secondary operation; one of the large inner diameter sleeve assemblies serves as an endoscope channel; while the other large inner diameter cannula assembly serves as the primary channel for the surgeon to perform the procedure. The primary channel described herein, about 80% of the time, was used with a 5mm instrument; about 20% of the time other large diameter instruments are applied; and the 5mm instrument and the large-diameter instrument need to be frequently switched in the operation. The time for applying the small-diameter instrument is longest, and the sealing reliability is important; the application of large diameter instruments is often a critical stage in surgery (e.g., vascular closure and tissue suturing), where switching convenience and operational comfort are important.

Along with the wide development of laparoscopic surgery in gynaecology and gastroenterology fields, the types of surgery are more and more abundant, and the requirements for puncture outfits are also remarkably diversified. For example, a typical bowel procedure requires a 15mm stapler to be inserted into the patient via a perforator, whereas typically the main path is a 10mm or 12mm perforator, requiring an additional 15mm puncture path to be established. For example, a typical gynecological procedure requires the creation of a 15mm penetration channel to facilitate removal of the excised uterine tissue, whereas the main channel is typically a 10mm or 12mm penetrator, requiring the creation of an additional 15mm penetration channel. In the two aforementioned surgical scenarios, if the diameter of the puncture channel can be conveniently switched from 10mm (12 mm) to 15mm for inserting the anastomat to anastomose or take out larger diseased organ (tissue), the additional puncture channel can be reduced, and the damage to the patient can be reduced. To date, there is no puncture outfit of this type.

Disclosure of Invention

In order to solve one or more problems of the background art, the present invention proposes a reducing sleeve device comprising a reducing sleeve assembly, a lower cover plate and a lower housing, the lower cover plate and the lower housing clamping and fixing the reducing sleeve assembly, wherein: the reducer sleeve assembly comprises at least two half approximately symmetrical movable sleeves and fixed sleeves and a film sleeve wrapping the movable sleeves and the fixed sleeves, wherein the movable sleeves, the fixed sleeves and the film sleeve form a hollow channel for accommodating the in and out of a surgical instrument; the movable sleeve is driven by the reducing driving mechanism to do linear motion along the transverse axis, which is close to or far from the longitudinal axis.

In one implementation of the invention, the reducer sleeve assembly includes an initial state and an expanded state: in the initial state, the movable sleeve and the fixed sleeve form a transverse section with a basic circular ring; in the inflated state, the movable sleeve is moved laterally away from the longitudinal axis, forming a lateral cross section having an inflated racetrack-type ring.

In one implementation scheme of the invention, the reducing driving mechanism comprises a transmission shaft and a driving knob, wherein the transmission shaft comprises a threaded driving section at the proximal end of the transmission shaft and a fixed section at the distal end of the transmission shaft, and the fixed section is fixedly connected with the movable sleeve; the drive knob comprises an internally threaded hole penetrating the drive knob from outside and a knob at the proximal end of the drive knob; and the internal threaded hole of the driving knob is matched with the threaded driving section of the transmission shaft to form threaded transmission.

In one implementation scheme of the invention, the reducing driving mechanism comprises a transmission shaft and a driving knob, wherein the transmission shaft comprises an internal threaded hole at the proximal end of the transmission shaft and a fixed section of which the distal end is fixedly connected with the movable sleeve; the drive knob includes a stud from its distal end and a knob from its proximal end; the stud of the driving knob is matched with the internal threaded hole of the transmission shaft to form threaded transmission.

In one implementation scheme of the invention, the reducing driving mechanism comprises a transmission shaft, a driving cam and a guide sleeve for limiting the transmission shaft to move along a transverse shaft; the proximal end of the transmission shaft comprises a shaft hole, the shaft hole is connected with the distal end hole of the driving cam through a shaft to enable the driving cam to rotate around the shaft, and the fixed section at the distal end of the transmission shaft is fixedly connected with the movable sleeve; the drive cam includes a first cam surface at a distal end thereof and second cam surfaces on opposite sides of the distal end thereof, the distal hole being spaced from the first cam surface a greater distance than the distal hole is spaced from the second cam surface.

In one embodiment of the invention, the movable sleeve and the stationary sleeve are made of metal material, and the movable sleeve and the stationary sleeve are formed in one piece by stamping or by cutting a round metal tube into symmetrical two parts.

In one embodiment of the present invention, the thin film sleeve material comprises a flexible material or an elastic material.

Another object of the present invention is to provide a puncture outfit, comprising a cannula assembly and a puncture needle penetrating the cannula assembly, wherein the cannula assembly comprises the cannula device, the cannula device further comprises a lower fixing ring, the lower shell and the lower fixing ring clamp fasten the film cannula, the cannula assembly comprises a first sealing assembly formed by fixing the duckbill to the cannula device in a sealing way by an upper fixing ring, and a second sealing assembly connected with the first sealing assembly in a buckling way.

Drawings

For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings in which:

FIG. 1 is a schematic diagram of a simulation of the abdominal puncture site for a typical laparoscopic procedure;

FIG. 2 is a schematic perspective view of a first embodiment of a sleeve assembly according to the present invention;

FIG. 3 is a partial cross-sectional view of a perspective view of the sleeve assembly of FIG. 2;

FIG. 4 is an exploded view of the second seal assembly of FIG. 2;

FIG. 5 is a cross-sectional view of the seal assembly of FIG. 4 after assembly;

FIG. 6 is a schematic perspective view of the first seal assembly of FIG. 3;

FIG. 7 is an exploded view of the first seal assembly of FIG. 6;

FIG. 8 is an exploded view of the reducer sleeve assembly of FIG. 7;

FIG. 9 is an assembled schematic view of the reducer sleeve assembly of FIG. 8;

FIG. 10 is a schematic perspective view of the lower housing of FIG. 7;

FIG. 11 is a schematic view of the diameter-variable sleeve assembly of FIG. 9 installed in a lower housing;

FIG. 12 is a partial cross-sectional view of the view shown in FIG. 11;

FIG. 13 is a schematic perspective view of the lower cover plate of FIG. 7;

FIG. 14 is a schematic view of the diameter-variable sleeve assembly of FIG. 11 being installed into a lower cover plate;

FIG. 15 is a cross-sectional view of the first seal assembly of FIG. 3 in an inflated condition;

FIG. 16 is a transverse cross-sectional view of the first seal assembly of FIG. 15 in an initial condition;

FIG. 17 is a schematic view of FIG. 17-17;

FIG. 18 is a schematic perspective view of a second embodiment sleeve assembly;

FIG. 19 is a partially exploded view of the variable diameter cannula device shown in FIG. 18;

FIG. 20 is a cross-sectional view of the first seal assembly of FIG. 18 in an initial state;

FIG. 21 is a cross-sectional view of the first seal assembly of FIG. 18 in an inflated condition;

FIG. 22 is a schematic perspective view of a third embodiment sleeve assembly; the method comprises the steps of carrying out a first treatment on the surface of the

FIG. 23 is a partially exploded view of the variable diameter cannula device shown in FIG. 22;

FIG. 24 is a cross-sectional view of the first seal assembly of FIG. 22 in an initial state;

FIG. 25 is a cross-sectional view taken along line 25-25 of FIG. 24;

FIG. 26 is an enlarged schematic view of the collar 26 shown in FIG. 25;

FIG. 27 is a cross-sectional view of the first seal assembly of FIG. 22 in an inflated condition;

FIG. 28 is a cross-sectional view taken along line 28-28 of FIG. 27;

FIG. 29 is an enlarged schematic view of the collar 29 shown in FIG. 28;

throughout the drawings, like reference numerals designate identical parts or elements.

Detailed Description

Embodiments of the present invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the disclosure herein is not to be interpreted as limiting, but merely as a basis for the claims and as a basis for teaching one skilled in the art how to employ the invention.

Referring to fig. 1-3, for convenience of description, the side closer to the operator is defined as proximal, the side farther from the operator is defined as distal, the central axis of the sleeve assembly 10 is defined as longitudinal axis 1000, the direction generally parallel to the longitudinal axis is defined as axial, the direction generally perpendicular to the longitudinal axis is defined as transverse, the central axis defining the variable diameter drive mechanism 102 is defined as transverse axis 2000, the direction from the distal end to the proximal end along transverse axis 2000 is defined as forward, and the direction from the proximal end to the distal end along transverse axis 2000 is defined as reverse.

As shown in fig. 1, which depicts the foregoing background of the gynecological and gastroenterology fields in which the 4 piercers 1 (2, 3, 4) penetrate into the abdominal cavity 6 of a patient, respectively, when the anastomat 5 is required to perform wound anastomosis or to remove a larger diseased organ (tissue), a 15mm cannula assembly is generally required for operation, and at the time of the minimally invasive operation, a 10mm cannula assembly can completely meet the use requirement. It will be appreciated by those skilled in the art that in order to reduce the size of the patient's wound and to reduce additional puncture passageways, if the puncture passageway diameter can be conveniently switched from 10mm (12 mm) to 15mm in diameter, it can be greatly convenient for the surgeon to operate and reduce trauma to the patient.

Fig. 2 to 17 illustrate in detail the overall structure of the puncture instrument according to the first embodiment of the present invention. As shown in fig. 3-7, a typical penetrator includes a needle 50 (not shown) and a cannula assembly 10. The cannula assembly 10 has an open proximal end 192 and an open cannula distal end 111. In a typical application, the needle 50 is passed through the cannula assembly 10 and then passed through the entire abdominal wall together through the percutaneous opening into the body cavity. Once inside the body cavity, the needle 50 is removed and the cannula assembly 10 is left as a passageway for instruments to enter and exit the body cavity. The proximal end 192 is outside the patient and the distal end 110 is inside the patient. A preferred sleeve assembly 10 is divided into a first seal assembly 11 and a second seal assembly 12. The clamping groove 119 of the component 11 is matched and fastened with the clamping hook 162a of the component 12. The cooperation of the hook 162a and the slot 139 is a quick-locking structure that can be quickly detached by one hand. This is mainly for the convenience of removing tissue or foreign matter from the patient during surgery. There are a number of implementations of the snap lock connection between the

components

11 and 12. In addition to the structures shown in this embodiment, threaded connections, rotary snaps, or other quick lock structures may be employed. Alternatively, the

components

11 and 12 may be designed in a structure that is not quickly detachable.

Fig. 3, 6-7 depict the composition and assembly relationship of the first seal assembly 11. The first seal assembly 11 comprises a variable diameter sleeve assembly 101 extending through the sleeve distal end 110 and a variable diameter drive mechanism 102 driving a diameter change thereof, the variable diameter drive mechanism 102 and the variable diameter sleeve assembly 101 being secured in an axial direction by a lower cover plate 104 and a lower housing 103 and a lower securing ring 105. The lower housing 103 has an inner wall 148 that supports a duckbill seal. The flange 176 of the duckbill seal 107 is sandwiched between the inner wall 148 and the upper retaining ring 106. The fixing manner between the upper fixing ring 106 and the lower housing 103 is various, and interference fit, ultrasonic welding, gluing, fastening and fixing may be adopted. The 4 mounting posts 161 of the upper retaining ring 106 in this embodiment are an interference fit with the 4 mounting holes 147 of the lower housing 103, which interference fit places the duckbill seal 107 in compression. The variable diameter sleeve assembly 101, variable diameter drive 102, inner wall 148, duckbill seal 107 and air inlet valve (not shown) together form a first chamber 13, the first chamber 13 defining an air inlet system passageway and also being a passageway for instruments to enter and exit the body cavity. In this embodiment, the duckbill seal 107 is a single slit, but other types of closed valves may be used, including flapper valves, multi-slit duckbill valves. When an external instrument penetrates the duckbill seal 107, its duckbill 173 can open, but it generally does not provide a complete seal against the instrument. When the instrument is removed, the duckbill 173 automatically closes, thereby preventing the fluid in the first chamber 13 from leaking outside. The reducer sleeve assembly 101, the reducer driving mechanism 102, the lower cover plate 104, the lower housing 103 and the lower fixing ring 105 together form a reducer sleeve device 15 for realizing the dimensional change of the sleeve diameter.

Fig. 3-5 depict the composition and assembly relationship of the second seal assembly 12. The sealing membrane assembly 108 is sandwiched between the upper cover 106a and the upper housing 109. The proximal end 182 of the sealing membrane assembly 108 is secured between the inner ring 166a of the upper cap 106a and the inner ring 196 of the upper housing 190. The upper housing 190 and the upper cover 106a may be fixed in various manners, such as interference fit, ultrasonic welding, gluing, fastening, etc. The embodiment shows that the upper case 190 and the upper cover 106a are connected by ultrasonic welding and fixed together by the housing 191. This fixation places the proximal end 182 of the sealing membrane assembly 108 in compression. The central opening 163 of the upper cap 106a, the inner ring 166a and the sealing membrane assembly 108 together form the second chamber 14.

Fig. 4-5 depict the composition and assembly relationship of the sealing membrane assembly 180. The sealing membrane assembly 180 comprises a sealing membrane 180 and a protection device 181. The protection device 181 is embedded in the sealing film 180. The protection device 181 is sized and shaped to fit inside the sealing membrane 180 without interfering with the sealing membrane 180. The protection device 181 moves or floats with the sealing membrane 180 to protect the central portion of the sealing membrane 180 from perforation or tearing by the sharp edges of the inserted surgical instrument. The sealing film 180 is generally made of an elastic material such as natural rubber, silica gel, isoprene rubber, etc.; the protective device 181 is typically made of a rigid or semi-rigid material such as thermoplastic elastomer, polypropylene, polyethylene, and the like.

Fig. 8-14 depict the composition and assembly relationship of the variable diameter cannula device 15. The reducing sleeve device 15 is composed of the reducing sleeve assembly 101, the reducing drive mechanism 102, a lower cover plate 104, a lower housing 103 and a lower fixing ring 105. The lower fixing ring 105, the lower cover plate 104 and the lower housing 103 clamp and fix the diameter-variable sleeve assembly 101 and the diameter-variable driving mechanism 102.

As shown in fig. 8 to 9, the variable diameter sleeve assembly 101 includes a movable sleeve 111 and a fixed sleeve 112 which are approximately symmetrical in two halves, and a film sleeve 113 which defines the movable sleeve 111 and the fixed sleeve 112 in an initial state to have an elongated tube. The active cannula 111 includes a semicircular active cannula distal end 1110 and an active cannula body 1111 extending proximally therefrom, the proximal semicircle of the active cannula body 1111 extending laterally outwardly to intersect the U-profile formed by the active cannula arcuate wall 1112 and the active cannula wall 1113 to form a wall 1116. The fixation sleeve 112 includes a semicircular fixation sleeve distal end 1120 and a fixation tube 1121 extending proximally therefrom, the proximal semicircle of the fixation tube 1121 extending laterally outwardly and intersecting a U-profile formed by the fixation sleeve arcuate wall 1122 and the fixation sleeve wall 1123 to form a wall 1126. The movable sleeve 111 and the fixed sleeve 112 are substantially mirror symmetrical in the axial direction, and L-shaped stopper bayonets 1114 (1124) are provided at proximal ends of the movable sleeve wall 1113 and the fixed sleeve wall 1123, which are in contact with each other, respectively. The movable sleeve arcuate wall 1112 of the movable sleeve 111 further includes a bore 1115 for mounting the fixed diameter drive mechanism 102. The active cannula distal end 1110 and the stationary cannula distal end 1120 together comprise the cannula assembly distal end 110.

The tube 1131 of the film sleeve 113 is sleeved and wrapped around the fixed tube 1121 and the movable tube 1111 to define a section having a substantially circular ring; the diameter of the pipe body 1131 is smaller than the combined diameter of the fixed pipe body 1121 and the movable pipe body 1111. The fixed sleeve arcuate wall 1122, fixed sleeve wall 1123 and movable sleeve arcuate wall 1112 and movable sleeve wall 1113 form a racetrack cross-section. The tube 1131 includes a proximal opening 1134 and a U-shaped body 1132 extending distally from the proximal opening 1134. The rotor 1132 includes a fixed surface 1133 at the bottom of the U-shaped rotor. It will be appreciated by those skilled in the art that in order to minimize the space required for the outer diameter of the elongated sleeve of the reducer sleeve assembly 101 while ensuring good strength, the film sleeve 113 is blow molded from a flexible film material such as PET, PP, PC, etc. The thickness of the film sleeve 113 is typically 0.1mm to 0.5mm. As a further alternative, as shown in fig. 25 and 28, the film sleeve 101a is blow molded from a flexible film material, such as PET, PP, PC, or the like. During the diameter-changing process, the film sleeve 101a is not elastically deformed or is slightly elastically deformed, and the diameter-changing increasing portion is formed mainly by stretching the folds compressed at the joint of the movable sleeve 111 and the fixed sleeve 112.

The movable sleeve 111 and the fixed sleeve 112 are formed by one-time stamping from a sheet metal material. It will be appreciated by those skilled in the art that the metallic materials used for the movable sleeve 111 and the fixed sleeve 112 include stainless steel alloy materials having good ductility and high forming strength, and other alloy materials suitable for stamping and satisfying biocompatibility can be applied to the present invention. In order to ensure the strength of the movable sleeve 111 and the fixed sleeve 112, the present embodiment uses a stainless steel material with a thickness of 0.8mm for one-time stamping forming, and it should be understood by those skilled in the art that it is also within the scope of the present invention that the movable tube 1111 of the movable sleeve 111 and the fixed tube 1121 of the fixed sleeve 112 may be stamped with outwardly protruding reinforcing ribs or increased in thickness for the purpose of increasing the strength. In another technical solution, the movable sleeve 111 and the fixed sleeve 112 are formed by cutting a circular metal tube into two symmetrical parts.

The variable diameter drive mechanism 102 described with reference to fig. 8 includes a drive shaft 124 and a drive knob 121 that pass through a bore 1115 of the movable sleeve 111 from the proximal end to the distal end and are fixed. The transmission shaft 124 includes, in order from the proximal end to the distal end, a threaded driving section 1241, a mounting groove 1242 for mounting the inner seal ring 123, a transmission shaft shoulder 1243, and a rivet fixing section 1244. It will be appreciated by those skilled in the art that the movable sleeve 111 and the transmission shaft 124 may be fixed by a conventional mechanical connection method such as a stud and nut method, a welding method, and a riveting method. In order to ensure that the space occupied by the transmission shaft 124 connected with the fixed movable sleeve 111 occupies the first chamber 13 as small as possible, the transmission shaft 124 and the movable sleeve 111 are fixed by riveting in the embodiment. The driving knob 121 includes an internally threaded hole 1213 passing therethrough from the outside, a knob 1210 at the proximal end of the driving knob 121, and a mounting groove 1212 for mounting the outer seal ring 122. The internally threaded bore 1213 of the drive knob 121 cooperates with the threaded drive section 1241 of the drive shaft 124 to form a threaded drive.

As shown in fig. 10, the lower housing 103 includes a hole 138 penetrating the reducer sleeve assembly 101, a first inner wall 137 defining the transverse movement of the fixed sleeve 112, a second inner wall 136 defining the transverse movement of the movable sleeve 111, and a third inner wall 135 formed by extending the first and second inner walls in a transverse straight line. The distance between the first and second inner walls is greater than the length of the fixed 1123 and movable 1113 sleeve walls of the assembled reducing sleeve assembly 101 by a difference approximately equal to the variable diameter value B. As mentioned above, typically, the surgeon typically needs to switch between 10mm and 15mm cannula assemblies, and to meet this requirement, the variable diameter value B is 5mm or more, which in this embodiment is 5mm.

The first inner wall 137 is shaped to mate with the fixed sleeve arcuate wall 1122 of the fixed sleeve 112 and the second inner wall 136 is shaped to mate with the movable sleeve arcuate wall 1112 of the fixed sleeve 111. The first, second and third inner walls 137 (136,135) together with the outwardly offset spigot outer walls thereof form the spigot slot 130. The lower housing 103 further includes an outer seal ring groove 134 defining an outer edge of the outer seal ring 122, a U-shaped outer wall 133 defining the drive knob 121, and a circumferentially disposed connection aperture 132. As shown in fig. 7, the lower fixing ring 105 includes a hole 152 slightly larger than the tube body 1131 of the film sleeve 113, and a fixing post 151 connected and fixed with the lower housing 103 in an interference fit manner. The lower retaining ring 105 also includes a boss 153 extending proximally from the bore 152. The boss 153 clamps the fixing surface 1133 of the fixing film sleeve 103 when the lower case 103 is fixed with the lower fixing ring 105.

As shown in fig. 13, the lower cover plate 104 includes a through hole 148 for passing instruments therethrough, and a spigot wall 140 extending axially from the distal end of the lower cover plate 104 to mate with the spigot slot 130 of the lower housing 103. The inside of the spigot wall 140 extends a stop rib 145 for defining a stop bayonet 1114 (1124). The lower cover plate 104 further includes a connection post 142 inserted into the connection hole 132 of the lower housing 103, and both form an interference fit. The lower cover plate 104 and the corresponding outer seal ring groove 134 of the lower housing 103 are provided with an outer seal ring groove 144, and the outer seal ring groove 134 (144) and the mounting groove 1212 together define the outer seal ring 122 to perform a sealing function. The outer wall 143 of the lower cover plate 104 and the U-shaped outer wall 133 together define the lateral outward movement of the drive knob 121.

As shown in fig. 8-14, the variable diameter sleeve device 15 generally comprises:

s1, mounting a reducer sleeve assembly 101, namely firstly riveting and fixing the movable sleeve 111 and a transmission shaft 124, and then sleeving a fixed sleeve 112 and the movable sleeve 111 which are combined into a basic sleeve into a film sleeve 113 from a sleeve assembly distal end 110 until the fixed sleeve 112 and the movable sleeve 111 are sleeved at the proximal ends, and exposing a sleeve assembly distal end 110 (shown in figures 8-9);

s2, installing the variable-diameter driving mechanism 102, sleeving an inner sealing ring 123 and an outer sealing ring 122 on a transmission shaft 124 and a driving knob 121 respectively, aligning an inner threaded hole 1213 of the driving knob 121 with a threaded driving section 1241 of the transmission shaft 124, and rotating a knob 1210 to connect the two, thereby completing the installation of the variable-diameter driving mechanism 102 (shown in figures 8-9);

and S3, sequentially assembling the lower cover plate 104, the lower shell 103, the reducer sleeve assembly 101 assembled in the step S2 and the lower fixing ring 105 in place (shown in figures 12 and 14).

The boss 153 of the lower fixing ring 105 clamps and fixes the fixing surface 1133 of the film sleeve 103 to fix the film sleeve 112; the connecting post 142 of the lower cover plate 104 is inserted into the connecting hole 132 of the lower housing 103 to form an interference fit, the spigot wall 140 of the lower cover plate 104 is inserted into the spigot groove 130 of the lower housing 103, and the lower cover plate 104 and the lower housing 103 define displacement in the axial direction of the reducer sleeve assembly 101 and the reducer driving mechanism 102. While the stop rib 145 of the lower cover plate 104 limits the stop bayonet 1124, together with the second and third inner walls 136 (135), to limit displacement of the retaining sleeve 112 in the transverse axis 2000 and in a transverse direction perpendicular to the transverse axis 2000. The second inner wall 136 limits the displacement of the movable sleeve 111 in the transverse direction perpendicular to the transverse axis 2000, and since the distance between the first and second inner walls is greater than the distance between the fixed sleeve wall 1123 and the movable sleeve wall 1113 of the combined reducing sleeve assembly 101, the movable sleeve 111 can be driven to move back and forth along the transverse axis 2000 by rotating the knob 1210, and the moving range is approximately equal to the difference B of the variable diameters.

The reducing process of the reducing cannula device 15 is depicted in detail in fig. 15-17. As shown in fig. 15 to 16, specifically, in the initial state, the tube body 1131 of the film sleeve 113 surrounds the fixed tube body 1121 of the fixed sleeve 112 and the movable tube body 1111 of the movable sleeve 111 to define a cross section having a substantially circular ring;

when the diameter is required to be adjusted, the knob 1210 is rotated clockwise along the transverse axis 2000, the internal thread 1211 of the driving knob 121 drives the thread driving section 1241 of the driving shaft 124 to move from the distal end to the proximal end in the forward direction, the movable sleeve 111 riveted with the driving shaft 124 also moves in the forward direction, the tubular body 1131 of the thin film sleeve 113 is expanded and expanded due to the movement of the movable tubular body 1111, the substantially circular cross section of the elongated tube becomes a racetrack-shaped cross section, and the maximum distance of the racetrack-shaped cross section is the diameter dimension after diameter change.

When the diameter-changed sleeve assembly 10 needs to be restored to the initial state, only the knob 1210 needs to be rotated anticlockwise along the transverse axis 2000, the internal thread 1211 of the driving knob 121 drives the threaded driving section 1241 of the driving shaft 124 to move in the reverse direction from the proximal end to the distal end, the movable sleeve 111 riveted with the driving shaft 124 also moves in the reverse direction, the tube body 1131 of the thin film sleeve 113 is contracted and restored due to the movement of the movable tube 1111, the runway-shaped section of the slender tube is changed back to the basic circular-ring-shaped section, and the initial state is restored.

According to the previous description, in the implementation, the dimension of the sleeve assembly with the diameter of 10mm can be changed according to the actual requirement of the operation, and any diameter dimension between 10mm and 15mm can be met. Since a sleeve assembly greater than 10mm is used at a relatively low frequency, the sleeve assembly 10 may be used as a conventional sleeve assembly when no diameter change is required. When the operation requires wound anastomosis using an anastomat or removal of a larger diseased organ (tissue), the surgeon may be more required to make a reduction, at which time, since the original cannula assembly 10 is simply reduced, no additional penetration channel is required, and the original cannula assembly is not required to be pulled out and additionally inserted into a large-sized cannula assembly. As shown in fig. 17, the section of the diameter-variable expanded sleeve assembly 10 is a racetrack, and compared with a basic ring with the same maximum diameter, the sleeve assembly 10 disclosed in this embodiment occupies smaller wound channel, and meanwhile, the muscle of the patient is directly transversely expanded in the original wound channel, so that the injury of the wound of the patient is not caused, the pain of the patient is greatly reduced, and the subsequent time for rehabilitation is reduced. In addition, those skilled in the art will appreciate that when the surgeon uses the cannula assembly of the prior art, the need to increase the puncture channel or switch the cannula assembly increases the workload of the surgeon, and the use of the cannula assembly 10 of the present invention can effectively reduce the working strength of the surgeon and the operation time.

Fig. 18 to 21 illustrate in detail the overall structure of the puncture instrument according to the second embodiment of the present invention. As shown in fig. 18, the sleeve assembly 20 includes a first seal assembly 21 and a second seal assembly 12, and this embodiment provides another alternative solution to the variable diameter driving mechanism 102 of the first seal assembly 11 based on the first embodiment.

Fig. 19-20 depict the composition and assembly relationship of the first seal assembly 21. The first seal assembly 21 comprises a variable diameter sleeve assembly 101 extending through the sleeve distal end 110 and a variable diameter drive mechanism 202 driving the diameter change thereof, said variable diameter drive mechanism 202 and variable diameter sleeve assembly 101 being secured in axial direction by the lower cover plate 104 and lower housing 103 and lower securing ring 105. The reducer sleeve assembly 101, the reducer driving mechanism 202, the lower cover plate 104, the lower housing 103 and the lower fixing ring 105 together form the reducer sleeve device 25 for realizing the dimensional change of the sleeve diameter.

Referring to fig. 8 and 19, the variable diameter drive mechanism 202 includes a drive shaft 224 and a drive cam 221 and a guide sleeve 225 that pass through a bore 1115 of the movable sleeve 111 from the proximal end to the distal end and are fixed. The transmission shaft 224 sequentially comprises a mounting shaft hole 2241 for penetrating through the hole 2212 of the driving cam 221 from the proximal end to the distal end through the shaft 226, a driving section 2241 penetrating through the guide sleeve 225, a mounting groove 2242 for mounting the inner sealing ring 223, a transmission shaft shoulder 2243 and a riveting fixing section 2244. It will be appreciated by those skilled in the art that the movable sleeve 111 and the transmission shaft 224 may be fixed by a conventional mechanical connection method such as a stud and nut method, a welding method, and a riveting method. In order to ensure that the space occupied by the transmission shaft 224 connected to the fixed movable sleeve 111 occupies the first chamber 23 (not shown) is as small as possible, the transmission shaft 224 and the movable sleeve 111 are fixed by riveting in this embodiment. The distal end of the drive cam 221 includes a distal bore 2212 and a first cam surface 2213, second cam surfaces 2214 on opposite sides of the distal end thereof, and a cam handle 2211 on the proximal end of the drive cam 221. The distance from the distal bore 2212 to the first cam surface 2213 is greater than the distance from the distal bore 2212 to the second cam surface 2214 by a difference B of approximately equal to the difference of the variable diameters.

Figures 20-21 depict the reducing process of the reducing cannula device 25 in detail. As shown in fig. 16, specifically, in the initial state, the tube body 1131 of the film sleeve 113 surrounds the fixed tube body 1121 of the fixed sleeve 112 and the movable tube body 1111 of the movable sleeve 111 to define a cross section having a substantially circular ring; the cam handle 2211 is rotated distally along the axis 226 and the second cam surface 2214 is generally flush with the outer wall of the lower housing 103.

When it is desired to adjust the diameter, the trigger cam knob 2211 is rotated about 90 degrees from the distal end to the proximal end along the shaft 226, and the first cam surface 2213 is substantially parallel to the outer wall of the lower housing 103. In this process, since the distance from the hole 2212 to the first cam surface 2213 is greater than the distance from the hole 2212 to the second cam surface 2214, the driving shaft 224 is driven to move in the distal direction and the proximal direction in the guide sleeve 225, the movable sleeve 111 riveted with the driving shaft 124 is also moved in the forward direction, the tube body 1131 of the film sleeve 113 is expanded due to the movement of the movable tube 1111, the basic circular section becomes a racetrack section, and the maximum distance of the racetrack section is the diameter after diameter change.

When it is desired to restore the reduced sleeve assembly 20 to its original state, the trigger cam knob 2211 is rotated approximately 90 degrees along the shaft 226 from the proximal end to the distal end, and the second cam surface 2214 is generally flush with the outer wall of the lower housing 103. In this process, since the distance from the hole 2212 to the first cam surface 2213 is greater than the distance from the hole 2212 to the second cam surface 2214, the driving shaft 224 is driven to move in the proximal and distal opposite directions in the guide sleeve 225, the movable sleeve 111 riveted with the driving shaft 124 is also moved in the opposite directions, the tube body 1131 of the film sleeve 113 is contracted and restored due to the movement of the movable tube 1111, the racetrack section of the elongated tube is changed back to the substantially circular section, and the initial state is restored.

It will be appreciated by those skilled in the art that the advantages and benefits of this embodiment over the first embodiment are substantially the same as the first embodiment in that only one pulling action is required to complete the maximum diameter change process, e.g., changing a 10mm sleeve assembly to a 15mm sleeve assembly, can be quickly completed. However, compared with the first embodiment, the diameter of the sleeve assembly is changed through knob thread adjustment, so that the diameter of the sleeve assembly is inconvenient to realize in the middle process, for example, the diameter of the sleeve assembly with 10mm is changed into a diameter with an intermediate value of 11mm,12mm and the like.

Fig. 22-29 depict in detail the overall construction of a third embodiment of the puncture instrument according to the present invention. As shown in fig. 22, the sleeve assembly 30 includes a first seal assembly 31 and a second seal assembly 12, and this embodiment provides another alternative solution to the variable diameter driving mechanism 102 and the variable diameter sleeve assembly 101 of the first seal assembly 11 based on the first embodiment.

Fig. 23-24 depict the composition and assembly relationship of the first seal assembly 21. The first seal assembly 31 comprises a variable diameter sleeve assembly 301 extending through the sleeve distal end 310 and a variable diameter drive mechanism 302 driving the diameter change thereof, the variable diameter drive mechanism 302 and the variable diameter sleeve assembly 301 being secured in the axial direction by a lower cover plate 304 and a lower housing 303 and a lower securing ring 105. The reducer sleeve assembly 301, the reducer drive mechanism 302, the lower cover plate 304 and the lower housing 303, and the lower retaining ring 105 together comprise a reducer sleeve assembly 35 for effecting dimensional changes in the diameter of the sleeve.

As shown in fig. 24, the reducer sleeve assembly 301 includes a movable sleeve 311 and a fixed sleeve 312 which are approximately symmetrical in two halves, and a thin film sleeve 313 which defines the movable sleeve 311 and the fixed sleeve 312 as having an elongated tube in an initial state. The movable sleeve 311 and the fixed sleeve 312 are substantially the same as the movable sleeve 111 and the fixed sleeve 112 of the first embodiment, but sealing edges 3116 (3126) extending laterally outwards are respectively added at the proximal ends of the movable sleeve 311 and the fixed sleeve 312, and the sealing edges 3116 (3126) cooperate with the lower cover plate 304 to ensure airtight.

The tube body 3131 of the film sleeve 313 is sleeved into and wraps the fixed tube body 3121 and the movable tube body 1111 of the fixed sleeve 312 and forms a fold 3131 at the seam of the fixed sleeve 312 and the movable tube body 1111; the diameter of the tube 3131 is larger than the combined diameter of the fixed tube 3121 and the movable tube 3111 of the movable sleeve 311. The tube 3131 further includes a proximal opening 3134, and a U-shaped rotator 3132 extending distally from the proximal opening 3134. In the present embodiment, the film sleeve 313 is made of a semi-rigid film material as compared with the film sleeve 113 of the first embodiment. During the diameter-changing process, the tube body 3131 of the thin film sleeve 313 is not elastically deformed or is slightly elastically deformed, and the diameter-changing increasing portion is formed by stretching the folds 3131 compressed at the joint of the fixed sleeve 312 and the movable tube body 1111.

23-24, the variable diameter drive mechanism 302 includes a drive shaft 324 and a drive knob 321 that extend through and are secured to a bore 3115 of the moveable sleeve 311 from a proximal end to a distal end. The drive shaft 324 includes a proximal to distal internally threaded bore 3241, a mounting groove 3242 for mounting the inner seal ring 123, and a weld securing section 3244. It will be appreciated by those skilled in the art that the movable sleeve 311 and the transmission shaft 324 may be fixed by a conventional mechanical connection method such as a stud and nut method, a welding method, and a riveting method. In this embodiment, the transmission shaft 324 and the movable sleeve 311 are fixed by welding. The driving knob 321 includes a distal stud 3213 and a knob 3210 at the proximal end of the driving knob 321. The stud 3213 of the driving knob 321 is matched with the internal threaded hole 3241 of the transmission shaft 324 to form threaded transmission. The variable diameter driving mechanism 302 of the present embodiment and the variable diameter driving mechanism 102 of the first embodiment are both threaded by stud and female screw hole, and mainly the stud 3213 of the driving knob 321 and the female screw hole 3241 of the driving shaft 324 are exchanged. The driving knob 321 is defined by a back-off 331 extending from the lower housing 303 along the transverse axis 2000 in a snap-fit manner, and is rotatable about a slot 322 inside the back-off 331 of the lower housing 303.

The reducing process of the reducing cannula device 35 is depicted in detail in fig. 24-29. As shown in fig. 24 to 26, specifically, in the initial state, the tube body 3131 of the film sleeve 313 is wrapped around the outer walls of the fixed tube body 1121 of the fixed sleeve 112 and the movable tube body 1111 of the movable sleeve 111, and a fold 3135 is formed at the joint of the fixed sleeve 312 and the movable tube body 1111;

when the diameter is required to be adjusted, the knob 3210 is rotated clockwise along the transverse shaft 2000, the driving knob 321 rotates around the groove 322 of the lower housing 303, and the stud 3213 of the driving knob 321 drives the internal threaded hole 3241 of the driving shaft 324 to move forward from the distal end to the proximal end, and the movable sleeve 311 welded with the driving shaft 324 also moves forward. Since the thin film sleeve 313 is made of a semi-rigid material, the tube body 3131 of the thin film sleeve 313 is not elastically deformed or is slightly elastically deformed during the diameter-changing process, so that the tube body 3131 of the thin film sleeve 313 is stretched to be approximately flat along with the forward movement of the movable sleeve 311, the elongated tube section of the diameter-changing sleeve assembly 301 is approximately ring-shaped, and the maximum distance of the ring section of the runway is the diameter size after diameter-changing.

When the diameter-changed sleeve assembly 30 needs to be restored to the initial state, the knob 3210 is rotated anticlockwise along the transverse axis 2000, the driving knob 321 rotates around the groove 322 of the lower housing 303, the stud 3213 of the driving knob 321 drives the internal threaded hole 3241 of the driving shaft 324 to move in the reverse direction from the proximal end to the distal end, and the movable sleeve 311 welded with the driving shaft 324 integrally moves in the reverse direction. Since the thin film sleeve 313 is made of a semi-rigid material, the tube body 3131 of the thin film sleeve 313 is not elastically deformed or is slightly elastically deformed during the diameter-changing process, so that the folds 3135 of the tube body 3131 of the thin film sleeve 313 are restored from the stretched state to the folded state along with the reverse movement of the movable sleeve 311, and the elongated tube section of the diameter-changing sleeve assembly 301 is changed from the approximately racetrack shape to the circular shape, and is restored to the original state.

Those skilled in the art will appreciate that the advantages and benefits of this embodiment compared to the first embodiment are substantially the same as those of the first embodiment, and will not be described here.

It should be understood by those skilled in the art that it is also within the scope of the present invention to use three or more sleeve members to form a reducer sleeve assembly, and that the description of the movable sleeve and the fixed sleeve should not be limited to use only a movable sleeve and a fixed sleeve, such as a fixed sleeve, but also to use a movable sleeve, i.e., to form two movable sleeves, and to drive the two movable sleeves to move in opposite directions by two reducer driving mechanisms, thereby realizing the reducer of the penetrator sleeve assembly.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art will be able to make adaptations to the method and apparatus by appropriate modifications without departing from the scope of the invention. Several modifications have been mentioned, and other modifications are conceivable to the person skilled in the art. The scope of the present invention should therefore be determined with reference to the appended claims, rather than with reference to the structures, materials, or acts illustrated and described in the specification and drawings.

Claims

1. The utility model provides a reducing sleeve device, includes reducing sleeve subassembly, lower apron and lower casing press from both sides reducing sleeve subassembly tight fixedly, its characterized in that:

the reducer sleeve assembly comprises at least two half approximately symmetrical movable sleeves and fixed sleeves and a film sleeve wrapping the movable sleeves and the fixed sleeves, wherein the movable sleeves, the fixed sleeves and the film sleeve form a hollow channel for accommodating the in and out of a surgical instrument;

the movable sleeve is in linear motion close to or far from the longitudinal axis along the transverse axis under the action of the reducing driving mechanism;

the reducing driving mechanism comprises a transmission shaft, a driving cam and a guide sleeve for limiting the transmission shaft to move along a transverse shaft; the proximal end of the transmission shaft comprises a shaft hole, the shaft hole is connected with the distal end hole of the driving cam through a shaft to enable the driving cam to rotate around the shaft, and the fixed section at the distal end of the transmission shaft is fixedly connected with the movable sleeve in a threaded mode, a welding mode and a riveting mode;

the drive cam includes a first cam surface at a distal end thereof and second cam surfaces on opposite sides of the distal end thereof, the distal hole being spaced from the first cam surface a greater distance than the distal hole is spaced from the second cam surface.

2. The cannula device of claim 1, wherein: the reducer sleeve assembly includes an initial state and an expanded state: in the initial state, the movable sleeve and the fixed sleeve form a transverse section with a basic circular ring; in the inflated state, the movable sleeve is moved laterally away from the longitudinal axis, forming a lateral cross section having an inflated racetrack-type ring.

3. The cannula device of claim 1, wherein: the movable sleeve and the fixed sleeve are made of metal materials, and the movable sleeve and the fixed sleeve are formed at one time by stamping or are cut into two symmetrical parts by cutting a round metal pipe.

4. The cannula device of claim 1, wherein: the thin film sleeve material comprises a flexible material or an elastic material.

5. A puncture outfit comprising a cannula assembly and a puncture needle penetrating the cannula assembly, characterized in that: the sleeve assembly comprises the sleeve device according to any one of claims 1-4, the sleeve device further comprises a lower fixing ring, the lower shell and the lower fixing ring clamp tightly fix the film sleeve, the sleeve assembly comprises a first sealing assembly formed by fixing the duckbill to the sleeve device in a sealing way through an upper fixing ring, and a second sealing assembly connected with the first sealing assembly in a buckling way.