WO2018218991A1

WO2018218991A1 - Variable-diameter cannula device and puncturing device

Info

Publication number: WO2018218991A1
Application number: PCT/CN2018/075810
Authority: WO
Inventors: 朱莫恕
Original assignee: 成都五义医疗科技有限公司
Priority date: 2017-06-03
Filing date: 2018-02-08
Publication date: 2018-12-06
Also published as: CN109602484A; CN107049438A; CN109602484B; CN107049438B

Abstract

Disclosed are a variable-diameter cannula device (15) and a puncturing device. The variable-diameter cannula device comprises a variable-diameter cannula assembly (101), a lower cover plate (104) and a lower housing (103). The variable-diameter cannula assembly (101) is clamped and fixed by the lower cover plate (104) and the lower housing (103). The variable-diameter cannula assembly (101) comprises at least one half movable cannula (111) and one half fixed cannula (112) approximately symmetrical to each other, and a film cannula (113) wrapping the movable cannula (111) and the fixed cannula (112). The movable cannula (111), the fixed cannula (112) and the thin-film cannula (113) form a hollow channel for the access of a surgical instrument. The variable-diameter cannula device further comprises a variable-diameter driving mechanism (102). Under the action of the variable-diameter driving mechanism (102), the movable cannula (111) linearly moves close to or away from a longitudinal axis (1000) along a transverse axis (2000).

Description

Reducer sleeve device and puncturing device

Technical field

The present invention relates to a minimally invasive surgical instrument, and more particularly to a trocar structure.

Background technique

A trocar is a surgical instrument used to create an artificial passage into a body cavity during minimally invasive surgery (especially for hard laparoscopic surgery). It usually consists of a cannula assembly and a puncture needle. The general clinical use is as follows: firstly, a small opening is cut in the skin of the patient, and then the puncture needle is inserted through the cannula assembly, but penetrates the abdominal wall through the skin opening to enter the body cavity. Once the body cavity is inserted, the needle is removed, leaving the cannula assembly as a passage for the instrument to enter and exit the body cavity.

In hard laparoscopic surgery, especially in laparoscopic surgery, the pneumoperitoneum is usually used to continuously perfuse the patient's abdominal cavity with gas (such as carbon dioxide gas) and maintain a stable air pressure (about 13 ~ 15mmHg) to obtain sufficient operation space. . The cannula assembly typically consists of a cannula, a housing, a sealing membrane (also known as an instrument seal), and a zero seal (also known as an automatic seal). The cannula penetrates from outside the body cavity into the body cavity as a passage for the instrument to enter and exit the body cavity. The outer casing joins the casing, zero seal and sealing membrane into a sealed system. The zero seal typically does not provide a seal for the insertion instrument and automatically closes and forms a seal when the instrument is removed. The sealing film tightens the instrument and forms a seal when the instrument is inserted.

In a typical gallbladder endoscopic procedure, four puncture channels are typically established in the abdominal wall of the patient, namely two small inner diameter cannula assemblies (typically 5 mm) and two large inner diameter cannula assemblies (typically 10 mm). The instrument that typically enters the patient via the small-diameter cannula assembly performs only ancillary procedures; one of the large-diameter cannula assemblies acts as an endoscope channel; and the other large-diameter cannula assembly serves as the primary access for the surgeon to perform the procedure. In this main channel, about 5% of the time applies 5mm instruments; about 20% of the time applies other large diameter instruments; and 5mm instruments and large diameter instruments need to be switched frequently during surgery. The application of small-diameter instruments takes the longest time, and its sealing reliability is more important; the application of large-diameter instruments is often a critical stage in the operation (such as vascular closure and tissue suture), and its switching convenience and operational comfort are more important.

With the extensive development of laparoscopic surgery in the field of gynecology and gastroenterology, the variety of surgery is becoming more and more diverse, and the demand for the trocar is also diversified. For example, in a typical bowel surgery, a 15 mm stapler needs to be inserted into the patient through a trocar. However, usually the main channel is a 10 mm or 12 mm trocar, and an additional 15 mm puncturing channel is required. For example, in a typical gynecological procedure, a 15 mm puncture channel is required to facilitate the removal of the cut uterine tissue. However, usually the main channel is a 10 mm or 12 mm trocar, and an additional 15 mm puncturing channel is required. In the above two surgical scenarios, if the diameter of the puncture channel can be easily switched from 10 mm (12 mm) to 15 mm in diameter, and the stapler can be inserted for anastomosis or a large diseased organ (tissue), the additional puncture channel can be reduced. Small damage to the patient. So far, there is no such type of trocar.

Summary of the invention

In order to solve one or more problems of the prior art, the present invention proposes a reducer sleeve device comprising a reducer sleeve assembly, a lower cover and a lower housing, the lower cover and the lower housing being changed The diameter sleeve assembly is clamped and fixed, wherein: the reducer sleeve assembly comprises at least two halves of approximately symmetrical movable sleeve and fixed sleeve, and a membrane sleeve surrounding the movable sleeve and the fixed sleeve, the activity The sleeve, the fixed sleeve and the film sleeve constitute a hollow passage for accommodating the access of the surgical instrument; and further comprising a variable diameter drive mechanism, the movable sleeve being moved closer to or away from the longitudinal axis along the horizontal axis by the variable diameter drive mechanism Linear motion.

In an implementation of the present 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 having a substantially annular shape; In the expanded state, the movable sleeve moves laterally away from the longitudinal axis to form a transverse cross-section with a swelled racetrack-type ring.

In an implementation of the present invention, the reducer drive mechanism includes a drive shaft and a drive knob, and the drive shaft includes a thread drive segment of a proximal end of the drive shaft and a fixed end of the drive sleeve connected to the movable sleeve The drive knob includes a female threaded bore extending therethrough and a proximal end thereof; the internally threaded bore of the drive knob cooperates with the threaded drive section of the drive shaft to form a threaded drive.

In an implementation of the present invention, the reducer drive mechanism includes a drive shaft and a drive knob, and the drive shaft includes an internally threaded hole at a proximal end of the drive shaft and a fixed end of the drive sleeve connected to the movable sleeve The drive knob includes a stud from a distal end thereof and a knob at a proximal end thereof; the stud of the drive knob cooperates with an internally threaded bore of the drive shaft to form a threaded drive.

In an implementation of the present invention, the reducer drive mechanism includes a drive shaft, a drive cam, and a guide sleeve for defining movement of the drive shaft along the horizontal axis; the drive shaft proximal end includes a shaft hole, the shaft The hole and the distal end of the drive cam are coupled to the shaft for rotation therewith, the fixed section of the distal end of the drive shaft is fixedly coupled to the movable sleeve; the drive cam includes a first cam surface at a distal end thereof and a distal end thereof a second cam surface on each side of the end, the distance from the distal end hole to the first cam surface being greater than the distance from the distal end hole to the second cam surface.

In an implementation of the invention, wherein the movable sleeve and the fixed sleeve are made of a metal material, the movable sleeve and the fixed sleeve are formed by stamping once or by cutting a circular metal tube into a symmetry Two parts.

In one implementation of the invention, the film sleeve material comprises a flexible material or an elastomeric material.

Another object of the present invention is to provide a trocar comprising a cannula assembly and a puncture needle extending through the cannula assembly, wherein the cannula assembly includes the cannula device, the cannula device further comprising a lower fixation ring, The lower housing and the lower retaining ring clamp the fixed membrane sleeve, the sleeve assembly comprising a first sealing assembly formed by sealing the duckbill to the cannula device by the upper retaining ring, and snapping with the first sealing assembly A second sealing assembly that is connected.

DRAWINGS

In order to more fully understand the essence of the present invention, a detailed description will be made with reference to the accompanying drawings, in which:

Figure 1 is a schematic view showing a simulated abdominal puncture position of a typical laparoscopic surgery;

Figure 2 is a perspective view of the sleeve assembly of the first embodiment of the present invention;

Figure 3 is a perspective partial cross-sectional view of the bushing assembly of Figure 2;

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

Figure 5 is a cross-sectional view of the sealing assembly of Figure 4 after assembly;

Figure 6 is a perspective view of the first sealing assembly of Figure 3;

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

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

Figure 9 is a schematic view showing the assembly of the reducer sleeve assembly shown in Figure 8;

Figure 10 is a perspective view of the lower case of Figure 7;

Figure 11 is a schematic view of the reduction sleeve assembly of Figure 9 loaded into the lower housing;

Figure 12 is a partial cross-sectional view of Figure 11;

Figure 13 is a perspective view of the lower cover shown in Figure 7;

Figure 14 is a schematic view of the reduction sleeve assembly shown in Figure 11 loaded into the lower cover;

Figure 15 is a cross-sectional view showing the first sealing member of Figure 3 in an expanded state;

Figure 16 is a transverse sectional view showing the initial state of the first seal assembly shown in Figure 15;

Figure 17 is a schematic view of 17-17 shown in Figure 15;

Figure 18 is a perspective view of the sleeve assembly of the second embodiment;

Figure 19 is a partial exploded view of the reducer sleeve device of Figure 18;

Figure 20 is a cross-sectional view showing the initial state of the first seal assembly shown in Figure 18;

Figure 21 is a cross-sectional view showing the state in which the first seal member shown in Figure 18 is inflated;

Figure 22 is a perspective view of a third embodiment of a cannula assembly;

Figure 23 is a partial exploded view of the reducer sleeve device of Figure 22;

Figure 24 is a cross-sectional view showing the initial state of the first seal assembly shown in Figure 22;

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

Figure 26 is an enlarged schematic view of the ring 26 shown in Figure 25;

Figure 27 is a cross-sectional view showing the state in which the first seal member shown in Figure 22 is inflated;

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

Figure 29 is an enlarged schematic view of the ring 29 shown in Figure 28;

In all the views, the same reference numerals indicate equivalent parts or parts.

detailed description

Embodiments of the present invention are disclosed herein, but it should be understood that the disclosed embodiments are merely examples of the invention, which may be implemented in various ways. Therefore, the disclosure of the present invention is not to be construed as limiting, but as a basis

Referring to FIGS. 1-3, for convenience of description, one of the parties immediately adjacent to the operator is defined as the proximal end, and the side remote from the operator is defined as the distal end, and the central axis defining the cannula assembly 10 is the longitudinal axis 1000, which is generally parallel. The direction of the longitudinal axis is referred to as the axial direction, and the subsequent direction substantially perpendicular to the longitudinal axis is referred to as the lateral direction, and the central axis defining the variable-diameter drive mechanism 102 is the horizontal axis 2000, and the distal end of the horizontal axis 2000 is referred to as the forward direction. Moving distally along the transverse axis 2000 to the distal end is referred to as reversal.

As shown in Fig. 1, the scene in the gynecological and gastroenterology field in the foregoing background is depicted, and four puncturing devices 1 (2, 3, 4) are respectively inserted into the abdominal cavity 6 of the patient, when it is necessary to use the stapler 5 When the wound is anastomosed or a large diseased organ (tissue) is removed, a 15 mm cannula assembly is usually required to operate, and in the time of minimally invasive surgery, the 10 mm cannula assembly can fully meet the requirements of use. Those skilled in the art should understand that in order to reduce the size of the wound of the patient and reduce the additional puncture channel, if the diameter of the puncture channel can be easily switched from 10 mm (12 mm) to 15 mm in diameter, the surgeon can greatly facilitate the operation and reduction of the surgeon. For the patient's injury.

2-17 detail the overall structure of the trocar of the first embodiment of the present invention. As shown in Figures 3-7, a typical trocar includes a puncture 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 puncture needle 50 extends through the cannula assembly 10 and then penetrates the entire abdominal wall through the skin opening into the body cavity. Once in the body cavity, the puncture needle 50 is removed and the cannula assembly 10 is left as a passage for the instrument to enter and exit the body cavity. The proximal end 192 is external to the patient and the distal end 110 is within the patient. A preferred cannula assembly 10 can be divided into a first seal assembly 11 and a second seal assembly 12. The card slot 119 of the assembly 11 and the hook 162a of the assembly 12 are fastened. The cooperation of the hook 162a and the card slot 139 is a quick lock structure that can be quickly split by one hand. This is mainly for the purpose of taking out tissues or foreign bodies in the patient during surgery. There are a number of implementations of the quick lock connection between the assembly 11 and the assembly 12. In addition to the structure shown in this embodiment, a threaded connection, a rotary snap or other quick lock structure may be employed. Alternatively, the assembly 11 and assembly 12 can be designed as structures that are not quick to split.

3, 6-7 depict the composition and assembly relationship of the first seal assembly 11. The first seal assembly 11 includes a reducer sleeve assembly 101 extending through the distal end 110 of the sleeve and a reducer drive mechanism 102 that drives a change in diameter thereof, the reducer drive mechanism 102 and the reducer sleeve assembly 101 being lowered by the lower cover 104 The lower case 103 and the lower fixing ring 105 are fixed in the axial direction. The lower housing 103 has an inner wall 148 that supports a duckbill seal. A flange 176 of the duckbill seal 107 is sandwiched between the inner wall 148 and the upper retaining ring 106. There are a plurality of fixing manners between the upper fixing ring 106 and the lower casing 103, and an interference fit, ultrasonic welding, glue bonding, snap fastening, and the like can be adopted. In this embodiment, the four mounting posts 161 of the upper retaining ring 106 are in interference fit with the four mounting holes 147 of the lower housing 103. This interference fit causes the duckbill seal 107 to be in a compressed state. The reducer sleeve assembly 101, the reducer drive mechanism 102, the inner wall 148, the duckbill seal 107, and an intake valve (not shown) collectively constitute a first chamber 13, which forms an intake air The system channel is also the channel through which the instrument enters and exits the body cavity. In this embodiment, the duckbill seal 107 is a single slit, but other types of closure valves may be used, including a tongue valve, a multi-slot duckbill valve. When the external instrument passes through the duckbill seal 107, its duckbill 173 can be opened, but it typically does not provide a complete seal with respect to the instrument. When the instrument is removed, the duckbill 173 automatically closes, thereby preventing fluid within the first chamber 13 from leaking out of the body. The reducer sleeve assembly 101, the reducer drive mechanism 102, the lower cover 104 and the lower housing 103, and the lower retaining ring 105 together form a reducer sleeve assembly 15 for effecting dimensional changes in the diameter of the sleeve.

Figures 3-5 depict the composition and assembly relationship of the second seal assembly 12. The sealing film assembly 108 is sandwiched between the upper cover 106a and the upper casing 109. The proximal end 182 of the sealing membrane assembly 108 is secured between the inner ring 166a of the upper cover 106a and the inner ring 196 of the upper housing 190. There are various ways of fixing between the upper casing 190 and the upper cover 106a, and an interference fit, ultrasonic welding, glue bonding, snap fastening, and the like can be adopted. This embodiment shows that the outer casing 191 of the upper casing 190 and the outer casing 161a of the upper cover 106a are fixed by ultrasonic welding. This fixation causes the proximal end 182 of the sealing membrane assembly 108 to be in a compressed state. The central opening 163 of the upper cover 106a, the inner ring 166a and the sealing membrane assembly 108 together form a second chamber 14.

4-5 depict the composition and assembly relationship of the sealing membrane assembly 180. The sealing film assembly 180 includes a sealing film 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 be mounted inside the sealing film 180 without interfering with the sealing film 180. The protective device 181 moves or floats with the sealing film 180 for protecting the central portion of the sealing film 180 from perforations or tears caused by the sharp edges of the inserted surgical instrument. The sealing film 180 is usually made of an elastic material such as natural rubber, silica gel, isoprene rubber or the like; the protective device 181 is usually made of a rigid or semi-rigid material such as a thermoplastic elastomer, polypropylene, polyethylene, or vinyl.

Figures 8-14 depict the composition and assembly relationship of the reducer sleeve assembly 15. The reducer sleeve device 15 is composed of the reducer sleeve assembly 101, the variable diameter drive mechanism 102, the lower cover 104 and the lower housing 103, and the lower retaining ring 105. The lower retaining ring 105, the lower cover 104 and the lower housing 103 clamp and fix the reducer sleeve assembly 101 and the reducer drive mechanism 102.

As shown in Figures 8-9, the reducer sleeve assembly 101 includes two halves of approximately symmetrical movable sleeve 111 and fixed sleeve 112 and defines the movable sleeve 111 and the fixed sleeve 112 in an initial state with A film sleeve 113 of the elongated tube. The movable sleeve 111 includes a semi-circular movable sleeve distal end 1110 and a movable tubular body 1111 extending proximally therefrom, the movable tubular body 1111 proximal semicircle extending laterally outwardly and the movable sleeve arcuate wall 1112 The U-shaped faces of the movable casing walls 1113 intersect to form a wall 1116. The fixed sleeve 112 includes a semi-circular fixed sleeve distal end 1120 and a fixed tubular body 1121 extending proximally thereof. The fixed tubular body 1121 has a proximal semicircle extending laterally outwardly and a fixed sleeve curved wall 1122. And the U-shaped faces of the fixed sleeve walls 1123 intersect 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 limit mounts 1114 (1124) are respectively disposed at the proximal ends of the movable sleeve wall 1113 and the fixed sleeve wall 1123 which are in contact with each other. The movable sleeve arcuate wall 1112 of the movable sleeve 111 further includes a bore 1115 for mounting the fixed reducer drive mechanism 102. The movable cannula distal end 1110 and the fixed cannula distal end 1120 together form a cannula assembly distal end 110.

The tube body 1131 of the film sleeve 113 is inserted into and wrapped around the fixed tube body 1121 and the movable tube body 1111 defines a section having a substantially circular shape; the diameter of the tube body 1131 is smaller than the diameter formed by the combination of the fixed tube body 1121 and the movable tube body 1111. The fixed sleeve arc wall 1122, the fixed sleeve wall 1123 and the movable sleeve arc wall 1112 and the movable sleeve wall 1113 form a racetrack section. The tubular body 1131 includes a proximal opening 1134 thereof and a U-shaped rotor 1132 extending laterally outwardly from the proximal opening 1134. The rotating body 1132 includes a fixing surface 1133 at the bottom of the U-shaped rotating body. Those skilled in the art will appreciate that the film sleeve 113 is blow molded from an elastic film material, such as PET, in order to minimize the space of the outer diameter of the elongated sleeve of the reducer sleeve assembly 101 while ensuring good strength. PP, PC and other film materials. The thickness of the film sleeve 113 is usually from 0.1 mm to 0.5 mm. In another optional technical solution, as shown in FIG. 25 and FIG. 28, the film sleeve 101a is blow molded from a flexible film material such as PET, PP, PC or the like. During the reducing process, the film sleeve 101a does not undergo elastic deformation or only slight elastic deformation, and the variable diameter is increased, mainly relying on the compression of the fold at the joint of the movable sleeve 111 and the fixed sleeve 112. form.

The movable sleeve 111 and the fixed sleeve 112 are stamped and formed from a sheet metal material. It should be understood by those skilled in the art that the metal material used for the movable sleeve 111 and the fixed sleeve 112 includes a stainless steel alloy material having good ductility and high molding strength, and other alloy materials suitable for stamping and satisfying biocompatibility are also It 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 adopts a stainless steel material having a thickness of 0.8 mm for one-time press forming, and those skilled in the art should understand that in order to increase the strength, the movable tube of the movable sleeve 111 It is also within the scope of the present invention to 1111 and the fixed tubular body 1121 of the fixed sleeve 112 to be stamped to form outwardly convex ribs or to increase the thickness thereof. 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 reducer drive mechanism 102 described with reference to FIG. 8 includes a drive shaft 124 and a drive knob 121 that are fixed through the bore 1115 of the movable sleeve 111 from the proximal end to the distal end. The drive shaft 124 includes a threaded drive section 1241 from the proximal end to the distal end for mounting the mounting groove 1242 of the inner seal ring 123, the drive shoulder 1243 and the riveting fixed section 1244. It will be appreciated by those skilled in the art that the movable sleeve 111 and the drive shaft 124 can also be fixed by a common mechanical connection such as a stud + nut method, a welding method, or a riveting. In order to ensure that the space of the transmission shaft 124 connecting the fixed movable sleeve 111 to occupy the first chamber 13 is as small as possible, in this embodiment, the transmission shaft 124 and the movable sleeve 111 are fixed by riveting. The drive knob 121 includes an internally threaded bore 1213 extending therethrough, a knob 1210 that drives the proximal end of the knob 121, and a mounting slot 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 transmission.

As shown in FIG. 10, the lower housing 103 includes an aperture 138 that can be threaded into the reducer sleeve assembly 101, a first inner wall 137 that defines a lateral movement of the fixed sleeve 112, and a second movement that defines the lateral movement of the movable sleeve 111. The inner wall 136 and the first inner wall and the second inner wall extend in a straight line to form a third inner wall 135. The distance between the first and second inner walls is greater than the length of the fixed sleeve wall 1123 and the movable sleeve wall 1113 of the combined reduced diameter sleeve assembly 101, the difference being substantially equal to the variable diameter value B. As mentioned above, usually the surgeon usually needs to switch between 10 mm - 15 mm cannula assemblies. To meet this need, the variable diameter value B ≥ 5 mm, and the variable diameter value B = 5 mm in this embodiment.

The first inner wall 137 is shaped to match the fixed sleeve arc wall 1122 of the fixed sleeve 112, which mates with the movable sleeve arc wall 1112 of the fixed sleeve 111. The first, second and third inner walls 137 (136, 135) together with the outer wall of the stop which is offset outwardly form a mouth groove 130. The lower housing 103 further includes an outer seal groove 134 defining an outer edge of the outer seal ring 122, a U-shaped outer wall 133 defining a drive knob 121, and a connection hole 132 disposed around. As shown in FIG. 7, the lower retaining ring 105 includes a hole 152 slightly larger than the tubular body 1131 of the film sleeve 113, and a fixing post 151 fixedly coupled to the lower casing 103. The lower retaining ring 105 also includes a boss 153 that extends proximally of the bore 152. The boss 153 clamps the fixing surface 1133 of the film sleeve 103 when the lower casing 103 and the lower fixing ring 105 are fixed.

As shown in FIG. 13, the lower cover 104 includes a through hole 148 for passing the instrument, and a stop wall 140 that is axially extended from the distal end of the lower cover 104 to match the lower housing 103 stop groove 130. The inside of the port wall 140 extends to define a limiting rib 145 of the limiting bayonet 1114 (1124). The lower cover 104 also includes a connecting post 142 that is inserted into the connecting hole 132 of the lower housing 103, and the two form an interference fit. The lower cover 104 and the corresponding lower casing 103 outer seal groove 134 are provided with an outer seal groove 144. The outer seal groove 134 (144) together with the mounting groove 1212 defines an outer seal ring 122 for sealing. The outer wall 143 of the lower cover 104 and the U-shaped outer wall 133 together define a drive knob 121 to move laterally outward.

8-14, the approximate assembly process of the reducer sleeve device 15 includes:

S1: The reducer sleeve assembly 101 is installed. The movable sleeve 111 is first riveted to the drive shaft 124, and then the fixed sleeve 112 and the movable sleeve 111 combined into a basic sleeve are sleeved from the distal end of the sleeve assembly 110. Into the film sleeve 113 and up to the proximal end of the fixed sleeve 112 and the movable sleeve 111, and expose the sleeve assembly distal end 110 (as shown in Figures 8-9);

S2: The reduction drive mechanism 102 is installed, and the inner seal ring 123 and the outer seal ring 122 are respectively sleeved on the drive shaft 124 and the drive knob 121, and the internal thread hole 1213 of the drive knob 121 is aligned with the thread drive section of the drive shaft 124. 1241 and rotating the knob 1210 to connect the two, complete the installation of the variable diameter drive mechanism 102 (as shown in Figure 8-9);

S3: The lower cover 104, the lower casing 103, and the reduction sleeve assembly 101 and the lower fixing ring 105 which are assembled in the S2 step are sequentially assembled in position (as shown in Figs. 12, 14).

The boss 153 of the lower fixing ring 105 clamps the fixing surface 1133 of the fixed film sleeve 103 to fix the film sleeve 112; the connecting post 142 of the lower cover 104 is inserted into the connecting hole 132 of the lower casing 103 to form an interference fit. The mouth wall 140 of the lower cover 104 is inserted into the mouth groove 130 of the lower casing 103, and the lower cover 104 and the lower casing 103 define displacement of the reducer sleeve assembly 101 and the reduction drive mechanism 102 in the axial direction. At the same time, the limiting rib 145 of the lower cover 104 limits the limiting bayonet 1124, together with the second and third inner walls 136 (135), restricts the displacement of the fixing sleeve 112 in the horizontal axis 2000 direction and the transverse direction perpendicular to the horizontal axis 2000. Directional displacement. The second inner wall 136 limits the lateral displacement of the movable sleeve 111 perpendicular to the transverse axis 2000, since the distance between the first and second inner walls is greater than the fixed sleeve wall 1123 and the movable sleeve of the combined reduced diameter sleeve assembly 101. The distance of the wall 1113 is so long that the movable sleeve 111 can be moved back and forth along the horizontal axis 2000 by rotating the knob 1210, and the range of movement is substantially equal to the difference B of the variable diameter.

The variable diameter process of the reducer sleeve assembly 15 is depicted in detail in Figures 15-17. Specifically, in the initial state, the tube body 1131 of the film sleeve 113 encloses the fixed tube body 1121 of the fixed sleeve 112 and the movable tube body 1111 of the movable sleeve 111 to define a section having a substantially circular ring. ;

When the adjustment of the diameter is required, the knob 1210 is rotated clockwise along the horizontal axis 2000, and the internal thread 1211 of the driving knob 121 drives the threaded driving section 1241 of the transmission shaft 124 to move from the distal end to the proximal direction, and is riveted integrally with the transmission shaft 124. The movable sleeve 111 also moves in the forward direction, and the tubular body 1131 of the membrane sleeve 113 is expanded by the movement of the movable tubular body 1111, and the basic annular section of the elongated tubular tube becomes a racetrack-type cross section. The maximum distance of the section is the diameter dimension after the diameter reduction.

When it is required to restore the tapered sleeve assembly 10 to the initial state, it is only necessary to rotate the knob 1210 counterclockwise along the horizontal axis 2000, and the internal thread 1211 of the drive knob 121 drives the threaded driving section 1241 of the drive shaft 124 from the proximal end to the far side. When the end moves in the opposite direction, the movable sleeve 111 which is riveted integrally with the transmission shaft 124 also moves in the reverse direction, and the tubular body 1131 of the membrane sleeve 113 is reduced and restored due to the movement of the movable tubular body 1111, and the runway section of the elongated tube is changed back. The basic ring-shaped cross section is restored to its original state.

According to the foregoing, in the present embodiment, the 10 mm cannula assembly can be dimensionally changed according to the actual needs of the operation, and can satisfy any diameter between 10 mm and 15 mm. Since the casing assembly greater than 10 mm is used less frequently, the casing assembly 10 can be used as a conventional casing assembly when no diameter reduction is required. When surgery requires the use of a stapler for wound anastomosis or removal of a large diseased organ (tissue), the surgeon may need to make a more variable. At this time, since only the original cannula assembly 10 is tapered, there is no need to increase it. The puncture channel does not require the original cannula assembly to be removed, and a large-sized cannula assembly is inserted. As shown in FIG. 17, the sleeve assembly 10 after the variable diameter is expanded, and the section of the reducer sleeve assembly 101 is a racetrack type, which is occupied by the sleeve assembly 10 disclosed in this embodiment, compared to the basic ring having the largest diameter. The wound channel is smaller, and the lateral expansion of the patient's muscle directly in the original wound channel does not cause damage to the patient's wound, greatly reducing the patient's pain and reducing the time required for subsequent rehabilitation. In addition, those skilled in the art should know that when the surgeon uses the prior art cannula assembly, it is necessary to increase the puncture channel or switch the cannula assembly, which also increases the workload of the surgeon, using the sleeve disclosed by the present invention. The tube assembly 10 can effectively reduce the working intensity of the surgeon and reduce the operation time.

18-21 detail the overall structure of the trocar of 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. The present embodiment is based on the first embodiment, and is mainly directed to the variable-diameter drive mechanism 102 of the first seal assembly 11 An optional technical solution.

19-20 depict the composition and assembly relationship of the first seal assembly 21. The first seal assembly 21 includes a reducer sleeve assembly 101 extending through the distal end 110 of the sleeve and a reducer drive mechanism 202 that drives a change in diameter thereof. The reducer drive mechanism 202 and the reducer sleeve assembly 101 are replaced by a lower cover 104 The lower case 103 and the lower fixing ring 105 are fixed in the axial direction. The reducer sleeve assembly 101, the reducer drive mechanism 202, the lower cover 104 and the lower housing 103, and the lower retaining ring 105 together form a reducer sleeve assembly 25 for effecting dimensional changes in the diameter of the sleeve.

Referring to FIGS. 8 and 19, the reducer drive mechanism 202 includes a drive shaft 224 and a drive cam 221 and a guide sleeve 225 that are fixed through the bore 1115 of the movable sleeve 111 from the proximal end to the distal end. The drive shaft 224 includes, in order from the proximal end to the distal end, a mounting shaft hole 2241 for penetrating the hole 2212 of the driving cam 221 through the shaft 226, and a driving section 2241 of the guiding sleeve 225 for mounting the mounting groove of the inner sealing ring 223 2242, drive shoulder 2243 and riveted fixed section 2244. Those skilled in the art will appreciate that the movable sleeve 111 and the drive shaft 224 may be fixed by a common mechanical connection such as a stud + nut method, a welding method, or a riveting. In order to ensure that the space of the transmission shaft 224 connecting the fixed movable sleeve 111 to occupy the first chamber 23 (not shown) is as small as possible, in this embodiment, the transmission shaft 224 and the movable sleeve 111 are fixed by riveting. The distal end of the drive cam 221 includes a distal bore 2212 and a first cam surface 2213, a second cam surface 2214 on either side of the distal end thereof, and a cam handle 2211 that drives the proximal end of the cam 221. The distance from the distal aperture 2212 to the first cam surface 2213 is greater than the distance from the distal aperture 2212 to the second cam surface 2214, and the distance difference B between the two is substantially equal to the difference in variable diameter.

Figures 20-21 detail the reduction process of the reducer sleeve assembly 25. Specifically, in the initial state, the tube body 1131 of the film sleeve 113 encloses the fixed tube body 1121 of the fixing sleeve 112 and the movable tube body 1111 of the movable sleeve 111 to define a section having a substantially circular ring; The cam handle 2211 is rotated to the distal end along the axis 226, and the second cam surface 2214 is substantially parallel to the outer wall of the lower housing 103.

When the adjustment of the diameter is required, the trigger cam handle 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 casing 103. During 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 drive shaft 224 is moved in the guide sleeve 225 toward the proximal end in the forward direction. The movable sleeve 111 which is integrally riveted with the drive shaft 124 is also moved in the forward direction, and the tubular body 1131 of the membrane sleeve 113 is expanded by the movement of the movable tubular body 1111, and the cross section of the basic circular ring becomes a racetrack type cross section. At this time, the maximum distance of the cross section of the racetrack type is the diameter dimension after the variable diameter.

When it is required to restore the tapered sleeve assembly 20 to the initial state, the trigger cam handle 2211 is rotated about 90 degrees from the proximal end to the distal end along the shaft 226, and the second cam surface 2214 is substantially attached to the outer wall of the lower housing 103. Parallel. During 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 drive shaft 224 is driven in the guide sleeve 225 in the opposite direction from the proximal end to the distal end. Moving, the movable sleeve 111 which is integrally riveted with the transmission shaft 124 is also moved in the reverse direction, and the tubular body 1131 of the membrane sleeve 113 is reduced and restored by the movement of the movable tubular body 1111, and the runway section of the elongated tube is changed back to the basic ring. The cross section of the type is restored to the initial state.

It should be understood by those skilled in the art that the present embodiment can complete the maximum variable diameter process such as changing the 10 mm bushing assembly into the 15 mm bushing assembly, as compared with the first embodiment, since only one pulling action is required. The advantages and advantageous effects are substantially the same as those of the first embodiment. However, this embodiment is different in diameter from the first embodiment by adjusting the knob thread, and it is inconvenient to achieve the reduction of the intermediate process, for example, changing the diameter of the intermediate value of the 10 mm bushing assembly to 11 mm, 12 mm, and the like.

22-29 detail the overall structure of the trocar of the third embodiment of the present invention. As shown in FIG. 22, the sleeve assembly 30 includes a first seal assembly 31 and a second seal assembly 12. The present embodiment is based on the first embodiment, and is mainly directed to the variable-diameter drive mechanism 102 of the first seal assembly 11. The radial bushing assembly 101 presents another alternative technical solution.

23-24 depict the composition and assembly relationship of the first seal assembly 21. The first seal assembly 31 includes a reducer sleeve assembly 301 extending through the sleeve distal end 310 and a reducer drive mechanism 302 that drives a change in diameter thereof, the reducer drive mechanism 302 and the reducer sleeve assembly 301 being lowered by the lower cover 304 The lower case 303 and the lower fixing ring 105 are fixed in the axial direction. The reducer sleeve assembly 301, the reducer drive mechanism 302, the lower cover 304 and the lower housing 303, and the lower retaining ring 105 together form 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 two halves of approximately symmetrical movable sleeve 311 and fixed sleeve 312 and defines the movable sleeve 311 and the fixed sleeve 312 in an initial state to have an elongated shape. The film sleeve 313 of the tube. 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 the movable sleeve 311 and the proximal end of the fixed sleeve 312 are respectively added outward. The laterally extending sealing edge 3116 (3126), the sealing edge 3116 (3126) cooperates with the lower cover 304 to ensure a hermetic shape.

The tube body 3131 of the film sleeve 313 is sleeved and wrapped around the fixed tube body 3121 and the movable tube body 1111 of the fixing sleeve 312 and forms a pleat 3131 at the joint between the fixed sleeve 312 and the movable tube body 1111; the tube body 3131 The diameter is larger than the diameter formed by the combination of the fixed tubular body 3121 and the movable tubular body 3111 of the movable sleeve 311. The tubular body 3131 further includes a proximal opening 3134 thereof and a U-shaped rotor 3132 extending laterally outwardly from the proximal opening 3134. The film sleeve 313 of the present embodiment is made of a semi-rigid film material as compared with the film sleeve 113 of the first embodiment. During the reducing process, the tube body 3131 of the film sleeve 313 does not undergo elastic deformation or only slight elastic deformation, and the variable diameter portion is mainly compressed by the joint between the fixed sleeve 312 and the movable tube body 1111. The folds of the 3131 stretch are formed.

Referring to Figures 23-24, the reducer drive mechanism 302 includes a drive shaft 324 and a drive knob 321 that pass through and are secured to the bore 3115 of the movable sleeve 311 from the proximal end to the distal end. The drive shaft 324 includes a proximally to distally threaded bore 3241, a mounting slot 3242 for mounting the inner seal 123, and a weld retaining section 3244. It will be appreciated by those skilled in the art that the movable sleeve 311 and the drive shaft 324 can be fixed by a common mechanical connection such as a stud + nut method, a welding method, or a riveting. In the embodiment, the transmission shaft 324 and the movable sleeve 311 are fixed by welding. The drive knob 321 includes a distal stud 3213 that drives a knob 3210 at the proximal end of the knob 321 . The studs 3213 of the drive knob 321 cooperate with the internally threaded holes 3241 of the drive shaft 324 to form a thread drive. The variable-diameter drive mechanism 302 of the present embodiment and the variable-diameter drive mechanism 102 of the first embodiment are both threaded and driven by a stud + internal thread, mainly for the stud 3213 of the drive knob 321 and the internally threaded hole of the drive shaft 324. The 3241 was interchanged. The driving knob 321 is defined by a buckle 331 and a buckle 331 extending along the horizontal axis 2000 of the lower casing 303, and is rotatable around the groove 322 inside the lower casing 303.

The variable diameter process of the reducer sleeve assembly 35 is depicted in detail in Figures 24-29. As shown in 24-26, specifically, in the initial state, the tube body 3131 of the film sleeve 313 is wrapped around the fixed tube body 1121 of the fixed sleeve 112 and the outer wall of the movable tube body 1111 of the movable sleeve 111, and in the fixed sleeve. The 312 and the movable tube body 1111 form a pleat 3135 at the joint; when the diameter is changed, the knob 3210 is rotated clockwise along the horizontal axis 2000, and the driving knob 321 rotates around the slot 322 of the lower casing 303 to drive the stud 3213 of the knob 321 The internally threaded hole 3241 of the drive shaft 324 is moved from the distal end to the proximal forward direction, and the movable sleeve 311 welded integrally with the transmission shaft 324 is also moved in the forward direction. Since the film sleeve 313 is made of a semi-rigid material, the tube body 3131 of the film sleeve 313 does not undergo elastic deformation or only slight elastic deformation during the diameter reduction process, so the tube body 3131 of the film sleeve 313 As the movable sleeve 311 moves forward, its pleats 3135 are stretched and stretched into an approximate plane, and the elongated tube section of the reduced-diameter sleeve assembly 301 is changed from an approximately circular shape to a racetrack type. The maximum distance of the section is the diameter dimension after the diameter reduction.

When the tapered sleeve assembly 30 needs to be restored to the initial state, the knob 3210 is rotated counterclockwise along the horizontal axis 2000, and the drive knob 321 is rotated around the slot 322 of the lower housing 303, and the stud 3213 of the drive knob 321 drives the drive shaft 324. The internally threaded hole 3241 is moved from the proximal end to the distal end in the opposite direction, and the movable sleeve 311 welded integrally with the transmission shaft 324 is also moved in the reverse direction. Since the film sleeve 313 is made of a semi-rigid material, the tube body 3131 of the film sleeve 313 does not undergo elastic deformation or only slight elastic deformation during the diameter reduction process, so the tube body 3131 of the film sleeve 313 As the movable sleeve 311 moves in the reverse direction, its pleats 3135 are restored to wrinkles from the stretched state, and the elongated tube section of the reduced-diameter sleeve assembly 301 is changed from the approximate runway type to the circular shape to return to the initial state.

It should be understood by those skilled in the art that the advantages and advantageous effects of the present embodiment are substantially the same as those of the first embodiment, and are not described herein.

The variable diameter sleeve assembly of the present invention adopts two halves of approximately symmetric movable sleeve and fixed sleeve to form a variable diameter sleeve assembly, and those skilled in the art should understand that three or more sleeves are used to form a variable diameter. The sleeve assembly is also within the scope of the present invention, and the description of the movable sleeve and the fixed sleeve of the present invention should not be limited to the use of only the movable sleeve and the fixed sleeve, such as a fixed sleeve or a movable sleeve. That is, two movable sleeves are formed, and the two movable sleeves drive the two movable sleeves to move in opposite directions to realize the diameter reduction of the piercer sleeve assembly.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art can make adaptations to the methods and apparatus by appropriate modifications without departing from the scope of the invention. Several corrections have been mentioned, and other modifications are also conceivable to those skilled in the art. Therefore, the scope of the invention should be construed in the appended claims and the claims

Claims

A reducer sleeve device includes a reducer sleeve assembly, a lower cover and a lower housing, and the lower cover and the lower housing clamp and fix the reducer sleeve assembly, wherein:

The reducer sleeve assembly includes at least two halves of approximately symmetrical movable sleeve and fixed sleeve and a membrane sleeve encasing the movable sleeve and the fixed sleeve, the movable sleeve, the fixed sleeve and the membrane The sleeve constitutes a hollow passage for receiving the access of the surgical instrument;

Also included is a variable diameter drive mechanism that moves linearly along the horizontal axis about or away from the longitudinal axis under the action of the reducer drive mechanism.
A bushing device according to claim 1, wherein said reducer sleeve assembly comprises an initial state and an expanded state: said active sleeve and said fixed sleeve are formed with a basic ring in said initial state The transverse section; in the expanded state, the movable sleeve moves laterally away from the longitudinal axis to form a transverse section having a swelled racetrack-type ring.
The bushing assembly of claim 1 wherein said reducer drive mechanism includes a drive shaft and a drive knob, said drive shaft including a threaded drive section at a proximal end of the drive shaft and a distal end thereof and a movable sleeve A fixed fixing segment is coupled; the drive knob includes a female threaded bore extending through the outer portion thereof and a proximal end thereof; the internally threaded bore of the drive knob cooperates with the threaded drive section of the drive shaft to form a threaded drive.
A bushing device according to claim 1 wherein said reducer drive mechanism includes a drive shaft and a drive knob, said drive shaft including an internally threaded bore at a proximal end of the drive shaft and a distal end thereof and a movable sleeve A fixed fixed section is coupled; the drive knob includes a stud from a distal end thereof and a knob at a proximal end thereof; the stud of the drive knob cooperates with an internally threaded bore of the drive shaft to form a threaded drive.
A bushing device according to claim 1 wherein said reducer drive mechanism includes a drive shaft and a drive knob, said drive shaft including an internally threaded bore at a proximal end of the drive shaft and a distal end thereof and a movable sleeve A fixed fixed section is coupled; the drive knob includes a stud from a distal end thereof and a knob at a proximal end thereof; the stud of the drive knob cooperates with an internally threaded bore of the drive shaft to form a threaded drive.
The bushing device of claim 1 wherein said reducer drive mechanism includes a drive shaft, a drive cam and a guide sleeve for defining movement of the drive shaft along a transverse axis; said drive shaft proximal end including a shaft bore The shaft hole is coupled to the distal end of the drive cam by a shaft for pivoting, the fixed portion of the distal end of the drive shaft is fixedly coupled to the movable sleeve; and the drive cam includes a first cam at a distal end thereof a second cam surface on both sides of the face and the distal end thereof, the distance from the distal end hole to the first cam surface being greater than the distance from the distal end hole to the second cam surface.
A bushing device according to claim 1, wherein said movable sleeve and said fixed sleeve are made of a metal material, said movable sleeve and said fixed sleeve being formed by stamping once or by passing a circular metal The tube is cut into two parts that are symmetrical.
The bushing device of claim 1 wherein said film sleeve material comprises a flexible material or an elastomeric material.
A trocar comprising a cannula assembly and a puncturing needle through the cannula assembly, wherein the cannula assembly comprises the cannula device of any of claims 1-8, the cannula device further comprising a lower fixation a ring, the lower and lower retaining rings clamp a fixed membrane sleeve, the sleeve assembly including a first sealing assembly comprising a cannula seal secured to the cannula device by an upper retaining ring, and a first seal The second sealing component of the component snap connection.