CN107080577B

CN107080577B - Sleeve assembly containing fold type air bag

Info

Publication number: CN107080577B
Application number: CN201710410206.5A
Authority: CN
Inventors: 谢万彬; 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: 2023-05-26
Anticipated expiration: 2037-06-03
Also published as: CN107080577A

Abstract

The present invention relates to a cannula assembly comprising a plicated balloon, comprising a first seal assembly and a second seal assembly, said second seal assembly comprising a lower housing and a hollow cannula connected thereto and extending distally, said first seal assembly, second seal assembly and hollow cannula comprising a communicating and substantially aligned instrument channel, said hollow cannula comprising an inner cylindrical surface and an outer cylindrical surface and a cannula wall therebetween; the distal end of the hollow cannula further comprising an open cannula lip comprising an angled cylindrical surface therebetween, the inner cylindrical surface and the angled cylindrical surface defining a cannula angled wall; the balloon assembly comprises a balloon lip and a balloon body connected with the balloon lip, wherein the balloon lip extends distally to form a balloon inclined wall matched with the shape and the size of the sleeve inclined wall; the balloon lip extends towards the proximal end, is connected with the balloon body and is in smooth transition; the balloon body includes a plurality of axially or annularly disposed pleats.

Description

Sleeve assembly containing fold type air bag

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a puncture outfit with an air bag.

Background

A puncture outfit is a surgical instrument used for establishing an artificial channel into a body cavity in a minimally invasive operation (especially a laparoscopic operation), and generally consists of a cannula assembly and a puncture 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.

At present, the abdomen feeding technology of laparoscopic surgery is mainly divided into two types: open (Hasson process) and closed (Veress needle process). The Hasson method is mainly used for patients who may have abdominal wall adhesions. The Hasson method generally firstly makes a 2cm incision along the upper edge or the lower edge of the navel, the incision penetrates through the whole abdominal wall, and then the incision is stretched into a finger for probing, so as to separate the adhesion between the abdominal wall and a omentum or an intestinal canal; the Hasson cannula system is then inserted under direct vision and carbon dioxide gas is injected into the patient's abdominal cavity via the Hasson cannula to form a pneumoperitoneum. The closed method is also called a direct puncture method, i.e. only making a small incision in the epidermis of the abdominal wall at the puncture site of the patient, and then penetrating the needle through the cannula assembly, through the abdominal wall and into the body cavity.

The Hasson sleeve systems currently disclosed are largely divided into three categories, the first category, for example, the sleeve assembly with a hinged structure disclosed in U.S. Pat. No. 5, 5203773, which is held by a hinged rotary expansion, is increasingly discarded due to the tendency to leak. The second type, such as the Hassan cannula system of the cone-shaped fastener and smooth cannula assembly of U.S. patent 5257973, is widely used because of its low cost by first suturing the cone-shaped fastener into the incision and then securing the smooth cannula assembly in the cone-shaped fastener, but its use is relatively complex and causes secondary injury to the patient. A third type, such as the balloon-containing sleeve assemblies disclosed in U.S. patent nos. 5468248, 6908454, 8888692, uses selective inflation of a syringe to secure the sleeve assembly to the patient's abdominal wall, and deflation releases the deflation balloon to facilitate insertion and removal of the sleeve assembly through the patient's skin incision. The inflation bladder can firmly secure the cannula assembly at the patient's skin incision and achieve sealing of the contact area with less trauma to the patient's wound. However, such balloon sleeve assemblies are complex in structure, relatively high in cost and expensive.

The balloon sheath assembly is generally used only in the Hasson process field, and so far the balloon sheath assemblies disclosed and commercialized are not substantially usable in the direct puncture process. The puncture outfit containing the air sac sleeve assembly has large resistance in the process of penetrating the body wall of a patient, which is not beneficial to the control of an operator or has large risk of puncturing the organs in the patient. While the balloon sheath assembly is favored by doctors for its more reliable attachment to the patient's abdominal wall relative to balloon-free sheath assemblies, the penetration force of balloon-containing sheath assemblies greatly limits the applicability of the balloon sheath assemblies in the field of direct penetration methods, and the balloon sheath assemblies disclosed and commercialized so far have not adequately addressed the greater penetration force.

Disclosure of Invention

To solve one or more of the technical problems of the background art, the present invention provides a cannula assembly comprising a plicated balloon, comprising a first sealing assembly and a second sealing assembly, the second sealing assembly comprising a lower housing and a hollow cannula connected thereto and extending distally, the first sealing assembly, the second sealing assembly and the hollow cannula comprising communicating and substantially aligned instrument channels, wherein the hollow cannula comprises an inner cylindrical surface and an outer cylindrical surface and a cannula wall therebetween; the distal end of the hollow cannula further comprising an open cannula lip comprising an angled cylindrical surface therebetween, the inner cylindrical surface and the angled cylindrical surface defining a cannula angled wall; the sleeve assembly further comprises an inflatable balloon assembly, a one-way valve assembly for inflating and deflating, and an air flow channel communicating the balloon assembly and the one-way valve assembly; the balloon assembly comprises a balloon lip and a balloon body connected with the balloon lip, wherein the balloon lip extends distally to form a balloon inclined wall matched with the shape and the size of the sleeve inclined wall; the balloon lip extends towards the proximal end, is connected with the balloon body and is in smooth transition; the air bag body comprises a plurality of folds which are axially or annularly arranged, and after the air bag body is deflated, emptied and folded, the folds are regularly piled up to avoid forming an annular step-shaped abrupt change structure perpendicular to the axis; the air bag assembly is arranged outside the hollow sleeve, the air bag lip is coated on the outer surface of the sleeve lip, and the air bag inclined wall and the sleeve inclined wall form taper fit; and an annular fully closed taper joint area is fixedly formed between the air sac inclined wall and the sleeve inclined wall so as to connect the air sac lip and the sleeve lip into a whole.

An optional technical proposal is that,the balloon lip and balloon body have a uniform wall thickness T _a3 T is not less than 0.05mm _a3 ≤0.1mm。

An alternative technical scheme, the air bag body comprises an air bag proximal end transition area, an air bag distal end transition area and an air bag main body extending between the air bag proximal end transition area and the air bag main body, wherein the air bag proximal end transition area comprises an equal-diameter corrugated pipe formed by transverse folds, and the air bag main body comprises a variable-diameter corrugated pipe with gradually increased zigzag steps formed by transverse folds from a distal end to a proximal end; and applying external force compression to convert the constant-diameter corrugated pipe into a diastole state, and compressing and attaching the variable-diameter corrugated pipe into a fish scale structure.

An alternative solution, the balloon body comprises a balloon proximal transition zone, a balloon distal transition zone, and a balloon body extending therebetween; the circumferentially disposed pleats on the balloon body include pleat peaks and pleat valleys and pleat walls extending therebetween, the pleats extending proximally from the distal end, the pleat walls extending proximally from the distal end of the balloon at a transition zone of the distal end of the balloon having progressively greater widths, the pleat walls extending proximally from the distal end of the balloon body having substantially equal widths, and the pleat walls extending proximally from the distal end of the balloon at a transition zone of the proximal end of the balloon having progressively less widths.

An alternative solution is to have the fold peaks at an acute angle a to the axis at the transition zone of the distal end of the balloon _d The method comprises the steps of carrying out a first treatment on the surface of the The fold peak forms an acute angle A with the axis at the transition zone of the proximal end of the air bag _p The method comprises the steps of carrying out a first treatment on the surface of the And A is _d ＜A _p 。

An alternative solution, the air bag assembly further comprises an outer sleeve comprising an outer tube proximal end, an outer tube distal end and an outer tube wall extending therebetween, the outer tube distal end and the outer cylindrical surface forming a non-fully closed seam area, and the outer tube proximal end and the outer cylindrical surface forming a fully closed proximal seam area secured to the outer surface of the valve seat of the outer cylindrical surface and the one-way valve assembly, an air flow channel being formed between the outer sleeve and the outer cylindrical surface in communication with the air bag assembly and the one-way valve assembly.

An optional technical scheme is that the fixing mode between the air bag inclined wall and the sleeve inclined wall comprises a welding mode or a glue bonding mode.

An optional technical scheme, wherein an included angle A between the inclined cylindrical surface and the inner cylindrical surface _lip Wherein A is less than or equal to 3 DEG _lip ≤15°。

An alternative technical scheme also comprises a fixing component fixed outside the body, wherein the fixing component comprises a fixing pad and a locking piece.

In another aspect of the present invention, there is provided a method of manufacturing the balloon assembly, wherein the balloon assembly comprises a first portion and a second portion cut from a distal end of an outer tube thereof, the method comprising the main steps of:

Blow molding and trimming process: producing and trimming said first portion by blow molding;

extrusion and cutting: manufacturing the second part by extrusion molding and trimming to a proper size;

welding process or bonding process: the second portion and the first portion overlap and are welded or bonded to form a seam area.

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 perspective view of a prior art penetrator 5;

FIG. 2 is an enlarged schematic view of a portion of the distal end of the penetrator 5 of FIG. 1;

FIG. 3 is a partial cross-sectional view of the distal portion of the penetrator 5 of FIG. 2;

fig. 4 is a schematic perspective view of a prior art puncture instrument 7;

fig. 5 is a partial cross-sectional view of the distal portion of a prior art inner sleeve 54;

FIG. 6 is a partial cross-sectional view of the distal portion of a prior art outer cannula 55;

FIG. 7 is an enlarged schematic view of a portion of the distal end of the penetrator 7 of FIG. 4;

FIG. 8 is a partial cross-sectional view of the distal portion of the penetrator 7 of FIG. 7;

fig. 9 is a perspective view of the cannula assembly 100 of the present invention;

FIG. 10 is an exploded view of the sleeve assembly 100 shown in FIG. 9;

fig. 11 is a perspective view of the lower cartridge body 123 shown in fig. 10;

Fig. 12 is an axial cross-sectional view of the lower cartridge body 123 shown in fig. 11;

FIG. 13 is an enlarged view of a portion of the distal end of the lower cartridge body 123 of FIG. 12;

FIG. 14 is a cross-sectional view of the airbag assembly 250 depicted in FIG. 10;

FIG. 15 is an enlarged view of a portion of the distal end of the balloon assembly 250 shown in FIG. 14;

FIG. 16 is an axial cross-sectional view of the second seal assembly 120 shown in FIG. 9;

FIG. 17 is an enlarged view of the distal portion of the assembly 120 shown in FIG. 16;

FIG. 18 is an enlarged partial view of the check valve assembly 140 shown in FIG. 16;

FIG. 19 is a cross-sectional view taken along line 19-19 of FIG. 18;

fig. 20 is an exploded view of the external fixation assembly 160;

FIG. 21 is an assembled perspective view of the retaining sleeve assembly of FIG. 20;

FIG. 22 is a cross-sectional view of the securing assembly shown in FIG. 20;

fig. 23 is a schematic perspective view of a cannula assembly 100 including an external fixation assembly;

FIG. 24 is a simulated view of the clinical application of the cannula assembly 100 of FIG. 23;

FIG. 25 is a simulated view of the airbag body 270 in a folded state;

FIG. 26 is a simulated view of balloon body 270 in a compressed state;

FIG. 27 is a schematic perspective view of an airbag module 450 according to another embodiment of the present invention;

FIG. 28 is an enlarged view of a cross-sectional view of a distal portion of the balloon assembly of FIG. 27;

FIG. 29 is a cross-sectional view taken along line 29-29 of FIG. 28;

FIG. 30 is a schematic perspective view of the lower cartridge body 123a (without an air bag installed) of another embodiment;

fig. 31 is a perspective view of the lower cartridge body 123a shown in fig. 30 (with an airbag installed):

FIG. 32 is a cross-sectional view of the distal portion of the lower cartridge body 123a shown in FIG. 31;

FIG. 33 is an inflated simulated view of the cross-section of FIG. 29 after inflation of the bladder;

FIG. 34 is a simulated view of the section of FIG. 29 after the balloon has been deflated;

FIG. 35 is a schematic perspective view of a balloon assembly 550 of yet another embodiment;

FIG. 36 is a schematic perspective view of a further embodiment of an airbag assembly 650;

fig. 37 is a perspective view of an airbag module 750 of yet another embodiment.

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. For convenience of description, the side closer to the operator is defined as the proximal end, the side farther from the operator is defined as the distal end, and the direction along the axial direction of the needle shaft or the cannula axis of the cannula assembly is defined as the axial direction, and the direction substantially perpendicular to the axial direction is defined as the lateral direction.

It will be appreciated by those skilled in the art that the penetrator will generally comprise a cannula assembly and a needle. The cannula assembly generally includes an instrument seal, a zero seal and a hollow cannula. For example, CN201610630336.5, entitled "a pleated puncture sealing system", the sleeve assembly disclosed in chinese application filed 8/2 of 2016, is incorporated herein by reference. The needle generally includes a handle portion, a shaft portion and a distal portion. For example, CN201611125444.3, the name of the invention "modified knife-free visual puncture needle", the puncture needle disclosed in chinese patent application filed 12/9 a 2016, is cited herein.

Referring to fig. 1-3, one prior art spike 5 for a direct lancing process includes a spike 10, a cannula assembly 30 and an axis 6. The needle 10 includes a handle portion 11 and a visual head 13, and a shaft portion 12 extending therebetween. From distal to proximal, the head 13 may be divided into a tip portion 19, a spear portion 18, a transition portion 17 and a base portion 16. The tip portion 19, spear portion 18, transition portion 17 and base portion 16 are connected in sequence, wherein the connection of the tip portion 19 to spear portion 18 may be non-smooth, as the tip portion and spear portion are relatively thin and sharp in shape and size, and act primarily as a piercing and separation action during penetration of the needle 10 into the patient's muscle or tissue. While the connection between the spear portion 18, transition portion 17 and base portion 16 is generally a streamlined, smooth transition to facilitate the collapse and inflation of the wound and reduce puncture forces. At the same time, the base portion 16 also includes a cylindrical portion 15 that matches the internal bore size of the cannula 32 of the cannula assembly 30 to facilitate a smooth transition between the needle and cannula assembly and to reduce the required penetration force required to squeeze and bulge the wound of the cannula assembly 30.

With continued reference to fig. 1-3, the sleeve assembly 30 includes a seal assembly 31 and a sleeve lip 40 with a hollow sleeve 33 extending therebetween. The sleeve 33 comprises a material having an inner diameter D ₁ And has an outer diameter D and an inner cylindrical surface 35 of (2) ₂ And a sleeve wall portion 36 therebetween. A 12mm gauge cannula assembly 30 wherein D ₁ ＝12.8mm，D ₂ =14.6mm. The sleeve lip 40 includes an opening lip 49 and a transition lip 47 and an angled cylindrical surface 48 therebetween, the inner cylindrical surface 35 and the angled cylindrical surface 48 defining an angled wall portion 46. The inclined wall portion 46 has a wall thickness T at the opening lip position ₁ The wall thickness at the position of the transitional lip is T ₂ The sleeve wall portion 36 has a wall thickness approximately equal to T ₂ The method comprises the steps of carrying out a first treatment on the surface of the The wall thickness of the angled wall portion 46 increases from the distal end to the proximal end, typically at a lesser rate, to provide a smoother transition between the needle 10 and the cannula assembly 30. Referring now primarily to FIG. 3, in a typical design, 0.1mm T ₁ ≤0.3mm，0.8mm≤T ₂ An included angle A between the inclined cylindrical surface 48 and the inner cylindrical surface 35 is less than or equal to 1.1mm ₁ ，3°≤A ₁ Less than or equal to 15 degrees; length L of the inclined wall portion 46 in the axial direction ₁ ，6mm≤L ₁ ≤12mm。

In the balloon sleeve assemblies disclosed or commercialized, such as those disclosed in US5468248 and US6908454, which contain a balloon of elastomeric material, a double layer sleeve is typically employed with the aid of glue bonding to secure the balloon, with a non-smooth sleeve lip transition, and are not generally useful in the field of the direct puncture method. A cannula assembly comprising a balloon of non-elastic material, such as disclosed in US8888692 (P692 for short), has a smaller outer diameter, which helps to reduce the penetration force of the penetration process. The balloon sleeve assembly cited herein and disclosed in patent P692. Fig. 4-8 depict a balloon-containing puncture instrument 7 that is substantially identical to the balloon-containing puncture instrument disclosed in said patent P692. Briefly, the penetrator 7 includes a needle 10, a balloon cannula assembly 50 and an axis 8. The balloon sheath assembly 50 comprises a sealing assembly 51 and a distally extending sheath 53 connected thereto, the sheath 53 comprising an inner sheath 54 and an outer sheath 55. Referring now to fig. 5, the inner sleeve 54 includes a sleeve lip 60 and a hollow tube portion 56 connecting it to the seal assembly 51. The hollow tube portion 56 includes a tube having an inner diameter D ₁ And has an outer diameter D and an inner cylindrical surface 61 of (2) ₄ And sleeve wall portion 62 therebetween. The sleeve lip 60 includes an angled cylindrical surface 68 between an opening lip 69 and a transition lip 67, the inner cylindrical surface 61 and the angled cylindrical surface 68 defining an angled wall portion 66. The hollow tube portion 56 is adjacent to the annular groove 70 of the sleeve lip 60, the annular groove 70 including a step surface 79 and a transition surface 77 and a diameter D therebetween ₇ Is provided with a recess surface 78. The groove 70 divides the sleeve wall portion 62 into three portions, sleeve distal wall 62a, sleeve groove wall 62b and sleeve proximal wall 62 c. The area adjacent the location where the hollow tube portion 56 connects to the seal assembly 51 contains the one-way valve assembly 52, and the flow passage 58 extends along the sleeve wall portion 62 and communicates the groove 70 with the one-way valve assembly 52. With continued reference to FIG. 5, in a typical design, the sloped wall portion 66 has a wall thickness T at the opening lip location ₃ The wall thickness at the position of the transitional lip is T ₄ The sleeve is concaveWall thickness T of groove wall 62b ₅ Wherein T is more than or equal to 0.1mm ₃ ≤0.3mm，1.15mm≤T ₄ ≤1.25mm，0.6mm≤T ₅ Less than or equal to 0.8mm. An included angle A between the inclined cylindrical surface 68 and the inner cylindrical surface 61 ₄ ，25°≤A ₄ 45 DEG or less, a length L of the inclined wall portion 66 in the axial direction ₄ ，2mm≤L ₄ ≤5mm。

Referring now to fig. 6, the outer cannula 55 includes an outer cannula distal end 89 and an outer cannula proximal end 87 with a hollow cannula portion 88 therebetween. The balloon 80 is disposed in the vicinity of the distal end 89 of the outer tube, wherein the balloon 80 comprises a balloon body 81, and a balloon distal transition zone 83 extending distally from the balloon body 81 and connected to the distal end 89 of the sleeve; and a balloon proximal transition zone 82 extending proximally from the balloon body 81 and connected to the hollow tube portion 88. The balloon distal end 89 includes an inner diameter D ₇ An outer diameter of D ₈ Wall thickness T ₇ Is provided for the cylindrical wall 84. The wall thickness T of the air bag body 81 ₈ Less than the wall thickness T ₇ The wall thickness of the transition zone 83 (82) is defined by T ₇ Gradual change to T ₈ . In a typical design and fabrication scheme, the outer sleeve 55 is fabricated by stretch blow molding, wherein 0.2mm T ₇ ≤0.3mm，0.01mm≤T ₈ Less than or equal to 0.05mm and D ₈ ＜D ₄ 。

Fig. 7-8 depict schematic mating views of the inner sleeve 54 and outer sleeve 55 at distal positions. Wherein the outer tube distal end 89 and balloon 80 are mounted at the annular groove 70, wherein the outer tube distal end 89 mates with the groove face 78 and step face 79. With the tie-down wire 91, the tie-down wire 92 secures the balloon proximal transition 82 and outer tube distal end 89, respectively, to the groove 70 and is sealed with glue. Typically, the outer tube distal end 89 remains sized to be less than or equal to the maximum outer diameter D of the sleeve lip 60 after winding the coil 92 ₄ . Referring now to fig. 3 and 8, the distal end of the introducer 5, the needle 10 and the cannula assembly 30 transition smoothly; while the distal end of the introducer 7, the transition between the needle 10 and the cannula assembly 50 is not smooth. Mainly comprises two non-smooth transition areas, one is that the size between the visual head 13 and the sleeve lip 60 is suddenly changed, so that the transition is non-smoothSliding; the second is that the transition of the balloon itself is not smooth, especially the wall thickness of the distal transition 83 is uneven and the profile is not smooth. One of ordinary skill will appreciate that the abrupt change in size between the visual head 13 and the cannula lip 60 may be reduced by reducing the included angle A4, however, the included angle a is reduced ₄ While ensuring that the annular groove 70 has sufficient strength while ensuring D ₈ ＜D ₄ The length L4 of the inclined wall portion 66 in the axial direction should be 10mm or more. And the balloon body 81 and the outer tube distal end 89 are generally 20mm or more in dimension in the axial direction. It will be appreciated by those skilled in the art that the length of the distal end of the

cannula assembly

30 or 50 penetrating the abdominal wall into the abdominal cavity is typically no more than 20mmm due to patient abdominal space constraints, which otherwise would affect the surgical procedure or result in risk of accidentally injuring internal organs and the like during the puncturing procedure, and thus cannot lengthen L ₄ To reduce transient mutations.

The impact of the transition mutation on penetration force is considerable: for example, the 12mm sized balloon sleeve assembly disclosed in patent P692 (without balloon folding) has substantially zero or very little resistance through the tissue incision and a peak resistance of 25 pounds when the balloon is passed through the incision; and when the airbag folding technique was used, its peak resistance dropped to 13 pounds. This is mainly because the regular folding of the balloon reduces abrupt changes in structural dimensions caused by the irregular accumulation of the balloon body during puncturing, thereby contributing to a greater reduction in puncture resistance. It will be appreciated by those skilled in the art that the difference in resistance caused by the abrupt change in the magnitude of the flexible balloon body is already substantial and that the increase in resistance caused by the abrupt change in rigidity between the visual head 13 and the cannula lip 60 will be more pronounced. The penetration force (direct penetration) of a 12mm gauge visual needle through the abdominal wall of a patient is about 15 pounds as disclosed in U.S. patent application 20070066988 A1. Operating comfort at lancing forces typically below 15 lbs. is good, while operating at lancing forces above 18 lbs. will typically affect the surgeon's control of the lancing process. Obviously, if the resistance of the air sac suddenly increased and the resistance caused by the suddenly changed between the visual head 13 and the sleeve lip 60 are calculated, the puncture outfit 7 cannot be basically applied to the direct puncture method.

Fig. 9-10 depict a sleeve assembly 100 according to a first embodiment of the present invention. The sleeve assembly 100 includes an axis 101 and first and second axially disposed

seal assemblies

110, 120. The first seal assembly 100 includes an instrument seal 112 sandwiched between an upper cartridge body 111 and an upper cap body 113. The second seal assembly comprises a zero seal 122 sandwiched between a lower cap 121 and a lower cartridge 123. The upper bin body 113, the upper cover body 117, the lower cover body 121 and the lower bin body 123 are sequentially connected to form the housing 103. The housing 103, instrument seal 112 and zero seal 122 form a sealing system comprising generally aligned holes. The instrument seal 112 grips the instrument and forms a seal when an external instrument is inserted into the cannula assembly 100; the zero seal 122 generally does not provide a seal to the inserted instrument, but automatically closes and forms a seal when the instrument is removed. For economy of description, the details of the structure of the upper housing 111, the instrument seal 112, the upper cover 113, the lower cover 121, the zero seal 122, and the manner in which the same are attached and described are omitted, and the above structure can be understood in conjunction with the description of the related art disclosed in the aforementioned chinese patent application CN 201610630336.5. Those skilled in the art will appreciate that there are a variety of implementations of the instrument seal 112 and zero seal 122 disclosed in the prior art, such as the four-flap instrument seal assembly disclosed in U.S. patent No. 8029475, such as the pleated instrument seal assembly disclosed in U.S. patent No. 7789861, such as the woven cloth-containing instrument seal assembly disclosed in U.S. patent No. 6482181, such as the four-flap zero seal disclosed in U.S. patent No. 5443452, such as the duckbill zero seal disclosed in U.S. patent No. 8034032, and so forth. The disclosed instrument seals, zero seals and their housings may be used to replace the instrument seals, zero seals, upper housing, upper cover, lower cover, etc. described herein.

With continued reference to fig. 9-10, the lower cartridge body 123 further includes a lower housing 124 and a hollow cannula 210 coupled thereto and extending distally therefrom. The lower housing 123 further includes a bladder assembly 250, a gas valve assembly 130 and a one-way valve assembly 140. The valve assembly 130 includes a valve body 130a and a valve cartridge 130b, the valve cartridge 130b being received in the valve body 130a and together into a valve mounting hole 125 extending transversely through the lower housing 124.

Referring now to FIGS. 11-13, the hollow cannula 210 includes a cannula having an inner diameter D _i And has an inner cylindrical surface 211 with an outer diameter D _o Is T in thickness and is formed between the outer cylindrical surfaces 213 _a1 A sleeve wall 212; the distal end of the hollow cannula 210 also includes an open cannula lip 220, the cannula lip 220 including an angled cylindrical surface 227 therebetween an open lip 229 and a transition lip 228, the inner cylindrical surface 211 and the angled cylindrical surface 227 defining a cannula angled wall 226. The sleeve inclined wall 226 has a wall thickness T at the location of the opening lip 229 _b1 The wall thickness at the location of the transition lip 228 is T _b2 . As discussed in the background, the wall thickness of the cannula bevel wall 226 increases from the distal end to the proximal end, generally at a lesser rate, so that the transition between the needle and cannula assembly is smoother. In a preferred design, T _b2 ＝T _a T is not less than 0.1mm _b1 ≤0.3mm，0.8mm≤T _b2 Less than or equal to 1.1mm. General T _b1 < 0.1mm difficult to manufacture and T _b1 A > 0.3mm resulted in a more severe transition non-smoothness. General T _b2 < 0.8mm then the hollow sleeve 210 is not strong enough, T _b2 The outer diameter of the hollow cannula 210 is too large at > 1.1mm, which is detrimental to minimizing trauma to the patient. In a further preferred embodiment, the angle a between the inclined cylindrical surface 227 and the inner cylindrical surface 211 is _lip Wherein A is less than or equal to 3 DEG _lip Less than or equal to 15 degrees. The A is _lip < 3 ° results in insufficient strength of sleeve lip 220 and is difficult to manufacture, while said a _lip The 15 ° results in an unsmooth transition between the needle and cannula assembly.

With continued reference to fig. 11-13, the proximal position of the hollow cannula 210 includes a valve seat 126 for mounting the one-way valve assembly 140. Referring now to fig. 11-12, the valve seat 126 includes a cylindrical sidewall defining a mounting bore 126a and a counter bore 126b. The hollow sleeve 210 further comprises a flow channel(s) 216, the flow channel 216 extending proximally along the outer cylindrical surface 213 to form a side hole 126c through the valve seat 126 in communication with the counter bore 126 b; the flow channel 216 extends distally to a distal portion of the hollow cannula 210, adjacent to the region of the cannula lip 220.

Referring now to fig. 14-16, the balloon assembly 250 includes an axis 251 and an outer sleeve 260 and a balloon lip 280 disposed along the axis, with a balloon body 270 therebetween. The balloon body 270 includes a balloon proximal transition 272 and a balloon distal transition 276 and a balloon body 274 extending therebetween. The bladder lip 280 includes a bladder opening lip 289 and a bladder transition lip 287 and a bladder angled wall 288 extending therebetween, the bladder angled wall 288 defining a conical aperture 286 that matches the shape and size of the sleeve angled wall 226. The balloon transition lip 287 extends distally and proximally and is seamlessly linked and smoothly transitions with the balloon distal transition region 276. The outer sleeve 260 includes an outer tube distal end 268 and an outer tube proximal end 264 and an outer tube wall 266 extending therebetween, the outer tube distal end 268 being seamlessly joined to and smoothly transitioning with the balloon proximal transition region 272, the outer tube wall 266 defining a cylindrical bore 265 conforming to the shape and size of the outer cylindrical surface 213, the outer tube proximal end 264 defining an outer tube opening 262. In a preferred embodiment, the bladder lip 280 and bladder 270 have a substantially uniform wall thickness T _a3 。

With continued reference to fig. 14-15, the balloon distal transition zone 276 includes a plurality of axially disposed pleats 311, each of the pleats 311 including pleat peaks 312 and pleat valleys 314 and pleat walls 313 extending therebetween. The plurality of pleats 311 are connected in sequence from the distal end to the proximal end into a seamless shell and extend laterally outwardly approximately equal in size to form the constant diameter bellows 310. The airbag body 274 includes a plurality of axially disposed pleats 321, each of the pleats 321 including pleat peaks 322 and pleat valleys 324 and pleat walls 323 extending therebetween. The plurality of pleats 321 are sequentially connected from the distal end to the proximal end to form a seamless shell, and the sizes of the pleat peaks 322, the lateral distances between the pleat valleys 324 and the axis 251 are gradually increased, namely, the plurality of pleats 321 form the variable-diameter corrugated tube 320 comprising zigzag steps.

Plastic materials can be generally classified into four types according to the hardness (Shore hardness) thereof, hard plastic (hardness is not less than 86D), medium hard plastic (83D is not less than 65D), semi-rigid plastic (98A is not less than 90A), and soft plastic (86A is not less than 10A). The hardness of the material can be measured according to the relevant regulations of astm d 2240-97. The air bag assembly 250 of the present invention is integrally blow molded from a hard plastic or a medium durometer plastic. The airbag materials, processes and methods of use disclosed in patent P692 may also be modified for use in the manufacture of the airbag module 250 of the present invention.

Referring now to fig. 16-17, the balloon assembly 250 is mounted on the exterior of the hollow sleeve 210 with a balloon lip 280 wrapped around the outer surface of the sleeve lip 220; the outer sleeve 260 is coated outside the outer cylindrical surface 213; the balloon sloped wall 288 mates with the sleeve sloped wall 226 to form a taper fit 230. In one implementation, an annular, fully enclosed taper seam region 299 is formed between the bladder diagonal wall 288 and sleeve diagonal wall 226 by welding (or by glue bonding) to join the bladder lip 280 and sleeve lip 220 as a single unit. The outer tube distal end 268 is welded or glued to the outer cylindrical surface 213 without bonding (welding) the outer tube distal end 268 to the flow channel 216 to form a non-fully enclosed seam region 297; the outer tube wall 266 is in contact with the outer cylindrical surface 213 but is not fixed or is fixed by glue bonding; the outer tube proximal end 264 is bonded to the outer cylindrical surface 213 and the outer surface of the valve seat 126 to form a fully enclosed proximal seam region 295. The one-way valve assembly 140, flow channel 216, outer cylindrical surface 213, balloon assembly 250, proximal seam region 295 and tapered seam region 299 form a closed balloon cavity 290.

Referring now to fig. 10, 16, 18 and 19, the check valve assembly 140 includes a bonnet 141, a check plug 145, a spring 146 and a valve seat 126. The bonnet 141 includes an air hole 147 therethrough, an inner wall 144 forming the air hole 147, and an outer wall 143. The inner wall 144 and the outer wall 143 form annular grooves and mate with mounting holes 126a defined by the valve seat 126, the mounting holes 126a communicating with the side holes 126 c. The outer wall 143 includes a resilient arm 142. The distal end of the resilient arm 142 is provided with a stop hole 142a sized and positioned to mate with a stop post 126d on the outside of the valve seat 126. When the check valve assembly 140 is installed, the spring 146 is first placed in the valve seat 126, then the check plug 145 is installed and the bonnet 140 is snapped onto the valve seat 126, the resilient arms 142 deform and then the retainer posts 126d enter the retainer holes 142a and compress the spring 146. The one-way plug 145 is urged outwardly and against the inner wall 144 of the bonnet 140 by the reaction force of the spring 146 to form a sealed fit.

In one implementation, a standard syringe is used to inflate or deflate via the one-way valve assembly 140. Referring to fig. 18-19, the air holes 147 are sized to match the shape and size of a standard syringe tip. The distal end of the air hole 147 includes a conical bore 147b, and the one-way plug 145 includes a conical body 145b that tapers to the conical body and a planar wall 145a that extends distally. The planar wall 145a includes a vent slot 145c and the cone 145b includes a straight or cross vent slot 145d. In a natural state, the reaction force of the spring 146 pushes the one-way plug 145 outwards, and the cone 145b is matched with the conical hole 147b to form a seal, so that the gas in the air bag cavity 290 is prevented from leaking.

Fig. 16-19 depict the inflation process of the airbag assembly 250. Specifically, the syringe SY port is inserted into the air hole 147 of the check valve assembly 140 and the check plug 145 is pushed inwardly, and then the air injection is performed. The gas passes through the

vent grooves

145c and 145d of the one-way plug 145, then enters the valve seat 126 through the gap of the inner wall 144 of the bonnet 140, and passes through the counter bore 126b, the side bore 126c, and the flow passage 216 enters the balloon body 270 to expand it. After the syringe SY is removed, the spring 146 pushes the one-way stopper 145 outwards, and the cone 145b and the conical hole 147b are matched to form a seal, so that gas leakage is avoided.

As shown in fig. 20-23, the cannula assembly 100 further includes an external fixation assembly 160, the external fixation assembly 160 including a fixation pad 150 and a lock 155. The mounting pad 150 material is a flexible material including, but not limited to, rubber, sponge, etc. The anchor pad 150 includes a pad distal end 151 and a pad proximal end 153 at its distal end and an annular pad slot 152 extending therebetween, the aperture 154 extending through the anchor pad 150 and having a diameter slightly smaller than the outer diameter of the outer sleeve 260 and being capable of being telescoping to the exterior of the outer sleeve 260 by inflation. The distal pad end 151 is snugly around the incision in the abdominal wall, protecting the incision from leakage of air pressure within the abdominal wall from the incision site. The lock 155 material includes a plastic material (e.g., polycarbonate) or a metal material (e.g., SUS 301) having good elasticity. The locking member 155 comprises a locking member body 156, and a handle 157 and a limit edge 159 extending from two ends of the locking member body 156. The lock body 156 is pre-crimped to form a lock aperture 158 and the lock 155 is crimped to provide an inward locking force. The inward crimping force of the lock body 156 staggers the handles 157 and the stop edges 159 at the ends of the lock body 156, the handles 157 staggering to form a generally V-shape. The lock hole 158 may be enlarged or contracted by pinching or releasing the two handles 157. 22-24, the locking member 155 is nested into the pad slot 152 of the anchor pad 150, and as the locking member 155 creates an inwardly curled locking force, the locking member 155 locks the anchor pad 150 and creates an inward holding force against the aperture 154 in the released state of the locking member 155.

Referring now to fig. 23-24, cannula assembly 30 is inserted through the patient's abdominal wall into a body cavity for access to the body cavity by instruments, and one or more cannula assemblies may be used simultaneously during the procedure. When a surgeon manipulates various instruments, such as graspers, scissors, staplers, and the like, into contact with the cannula assembly 30, frictional forces may result in movement of the cannula assembly 30 inwardly or outwardly along the abdominal wall, which may result in sliding out of the abdominal wall or further insertion into the body cavity, thereby making a secure attachment of the cannula assembly to the abdominal wall important. The balloon body 270 of the cannula assembly 100 is positioned within the body cavity and inflated, and the position of the external fixation assembly 160 is adjusted in the axial direction of the cannula assembly 100 such that the abdominal wall is clamped between the balloon body 270 and the external fixation assembly 160, thereby firmly securing the cannula assembly 100 to the abdominal wall while preventing movement of the cannula assembly 100 in or out of the body.

The balloon assembly 250 of the present example includes a pleated balloon body 270 that facilitates reducing puncture force. Referring now to fig. 16, 17, 25 and 26; wherein fig. 17 depicts the balloon body 270 in an initial state and in an inflated state; FIG. 25 depicts the balloon body 270 in a folded state; fig. 26 depicts the balloon body 270 in a compressed state. The following briefly describes the case where the balloon body 270 is changed from the initial state to the folded state, and then to the compressed state: as shown in fig. 17, in the initial state, the constant diameter bellows 310 is in a folded state and the variable diameter bellows 320 is in a relaxed state; as shown in fig. 25, applying an external force to axially stretch the pleats 311 to convert the constant diameter bellows 310 into a relaxed state, and simultaneously axially compress the pleats 321 to place the variable diameter bellows 320 in a folded state; as shown in fig. 26, the external force compression is continued until the pleats 321 are partially stacked on each other with the smallest lateral dimension, and the stacked pleats 321 form a fish scale-like structure. The air bag module of the prior art described above has a large puncture resistance caused by air bag mutation and material accumulation during the puncture process, while the fish scale structure formed by folding and compressing the folds as shown in fig. 26 is beneficial to reducing the mutation and the excessive accumulation of the material locally, thereby being beneficial to reducing the puncture force to a large extent. When the balloon body 270 of the sleeve assembly 100 is completely inserted into the body cavity of the patient through the wound, a gas injection device or instrument such as a syringe is used to inject enough gas into the balloon body 270 through the one-way valve assembly 140, and the injected gas pushes the folds 321 to relax and the reducing bellows 320 to expand. When the operation is completed, which requires the cannula assembly 140 to be pulled out, the balloon body 27 is evacuated and compressed by using a device or instrument such as a syringe via the one-way valve assembly 140.

Fig. 27-29 depict another embodiment airbag module 450 of the present invention. The balloon assembly 450 includes an axis 451 and an outer sleeve 460 and a balloon lip 480 disposed along the axis and a balloon body 470 therebetween. The balloon body 470 includes a balloon proximal transition 472 and a balloon distal transition 476 and a balloon body 474 extending therebetween. The balloon lip 480 includes a balloon opening lip 489 and a balloon transition lip 487 and a balloon lip wall 488 extending therebetween, the balloon lip wall 488 defining a cylindrical bore 486. The balloon transition lip 487 extends distally to proximally and is seamlessly linked and smoothly transitions with the balloon distal transition region 476. The outer sleeve 460 includes an outer tube distal end 468 and an outer tube proximal end 464, and an outer tube wall 466 extending therebetween, the outer tube distal end 468 being seamlessly joined and smoothly transitioned with the balloon proximal transition region 472, the outer tube wall 466 defining a cylinderBore 465, outer tube proximal end 464 defines outer tube opening 462. In a preferred embodiment, the bladder lip 480 and bladder 470 have a substantially uniform wall thickness T _a3 。

With continued reference to fig. 27-29, the balloon body 470 includes a plurality of circumferentially disposed pleats 411, each of the pleats 411 including pleat peaks 412 and pleat valleys 414 and pleat walls 413 extending therebetween. The plurality of pleats 411 extending distally to proximally, the width of the pleat walls 413 in the balloon distal transition 476 extending distally to proximally increasing; the width of the pleat walls 413 extending distally to proximally at the balloon body 474 remains substantially uniform; the pleat walls 413 at the balloon proximal transition 472 taper in width from distal to proximal. Referring to fig. 28, in a preferred embodiment, the fold peak 412 forms an acute angle a with the axis 451 at the balloon distal transition 476 _d The method comprises the steps of carrying out a first treatment on the surface of the The fold peak 412 forms an acute angle A with the axis 451 at the balloon proximal transition 472 _p The method comprises the steps of carrying out a first treatment on the surface of the And A is _d ＜A _p 。

Fig. 30-32 depict a lower cartridge body 123a of another embodiment of the present invention. The lower housing 123a is substantially identical to the lower housing 123 in structure and composition, and is mainly different in the manner of forming the airbag module and the flow path. Referring to fig. 30 and 32, in more detail, the lower cartridge body 123a includes a lower housing 124 and a hollow cannula 210 connected thereto and extending distally. The lower cartridge body 123 further comprises a balloon assembly 450 and a one-way valve assembly 140. The hollow cannula 210 includes a cannula having an inner diameter D _i And has an inner cylindrical surface 211 with an outer diameter D _o Is T in thickness and is formed between the outer cylindrical surfaces 213 _a1 A sleeve wall 212. The distal end of the hollow cannula 210 also includes an open cannula lip 420, the cannula lip 420 including an angled cylindrical surface 427 therebetween an open lip 429 and a transition lip 428, the inner cylindrical surface 211 and the angled cylindrical surface 427 defining a cannula angled wall 426. The sleeve angled wall 426 has a wall thickness Tb1 at the location of the opening lip 429 and a wall thickness Tb2 at the location of the transition lip 428, and in this embodiment Tb1 < Tb2 < Ta1. The hollow sleeve 210 also includes an annular groove 430 adjacent the sleeve lip 420. The annular recess 430 includes a distal step edge 439 and a proximal step edge 437 extending therebetween The extended outside diameter is Dg of the bottom surface 438 of the groove. The land 438 and the inner cylindrical surface 211 define a cylindrical wall 436 having a wall thickness Tg. The annular groove 430 also includes a partially recessed flow channel 440.

31-32, the balloon assembly 450 is mounted on the exterior of the hollow sleeve 210 of the lower cartridge body 123a, and the balloon assembly 450 may be secured to the exterior of the hollow sleeve 210 by glue bonding or other mechanical fastening. The present example employs a first tie ring 499 to secure the balloon lip 480 to the annular recess 430 adjacent the distal stepped edge 439 and form a fully enclosed distal seam region 498. The outer sleeve 460 is wrapped around the exterior of the outer cylindrical surface 213 and a second binding loop 497 is used to secure the outer tube distal end 468 to a location adjacent the proximal tube step 437 and form a non-fully enclosed seam area 496. The outer tube proximal end 464 is bonded to the outer cylindrical surface 213 and the outer surface of the valve seat 126 to form a fully enclosed proximal seam region 495. The outer tube wall 466 and the outer cylindrical surface 213 are not bonded or form a non-completely sealed bond, and a flow passage 216a (not shown) communicating with the air bag body 470 is reserved, i.e., a gap between the outer tube wall 466 and the outer cylindrical surface 213 replaces the flow passage 216. In summary, the check valve assembly 140, the flow channel 216a, the outer cylindrical surface 213, the balloon assembly 450, the proximal seam region 495, and the distal seam region 498 form a closed balloon cavity 490. One of ordinary skill in the art will readily appreciate that when the balloon-containing sleeve assembly penetrates the patient's abdominal wall and is cinched by the patient's muscle, the cinching force imparted by the muscle to the outer tube wall 466 may cause the gap between the outer tube wall 466 and the outer cylindrical surface 213 to decrease or even block, thereby blocking the flow passage 216a. The sleeve assembly disclosed in patent P692 has sleeve walls that each have recessed flow passages, possibly based on the consideration of preventing flow passage blockage. Normally, however, blocking the flow channel 216a does not occur. To date, the balloon chamber 490 is typically inflated or deflated using a conventional syringe, the inflation pressure of the syringe to the balloon chamber 490 being 25Psi to 30Psi, the force of the muscle's tightening against the outer tube wall 466 not being able to block the flow passage 216a. The lower cartridge body 123 has no recessed flow channel 216 on the outer cylindrical surface 213 of the lower cartridge body 123a, so that a relatively thinner sleeve wall 212 can be used to further reduce the outer diameter Do while ensuring sufficient strength of the hollow sleeve 210.

The balloon sleeve assembly 50 described above is deflated and folded, and it is difficult to avoid having one or more annular stepped abrupt structures formed at the distal end of the balloon sleeve assembly 50 generally perpendicular to its axis. Those skilled in the art will readily appreciate that the patient's muscles are resilient and that if the needle 10 described in the background is used to penetrate the cannula assembly 50 and the patient's abdominal wall via a percutaneous incision, the muscles will grip the outer surface of the needle and cannula assembly distal end during the penetration and inflation of the wound, and even the smaller annular stepped projections may significantly increase penetration resistance. Before the sleeve assembly including the balloon assembly 450 is assembled and then is filled into a final sterilization package, the balloon body 470 is evacuated through the one-way valve assembly 140, and as the balloon body 470 comprises circumferential folds, the structure of the circumferential folds is different, so that the shape of the evacuated balloon body 470 is basically regular, and a cross section formed by cutting the balloon body 470 along a cross section perpendicular to the axis of the balloon is approximately shown as 34. That is, the balloon body 470 is emptied and the balloon body material is deposited regularly to form a rib that extends proximally from the distal end, thereby avoiding the formation of one or more annular stepped abrupt structures at the distal end of its balloon sleeve assembly that are generally perpendicular to its axis, which helps to distribute puncture resistance. In particular, in the standard puncture technique, the surgeon is usually used to a small-range back and forth rotation and is penetrated into the body, and when the standard puncture technique is adopted, the inclined air bag has more remarkable effect of dispersing puncture resistance and reducing puncture peak force.

Fig. 35 depicts an airbag assembly 550 of yet another embodiment of the invention, fig. 36 depicts an airbag assembly 650 of yet another embodiment of the invention, and fig. 37 depicts an airbag assembly 750 of yet another embodiment of the invention. The airbag module 550,650,750 is substantially identical to the airbag module 450 in structure, and differs only in the folds and the shape of the airbag body, and has a function similar to that of the airbag module 450.

In yet another aspect of the invention, an improved, more easily manufactured airbag module and method of manufacturing the same is presented. Briefly, the balloon assembly 250 (450) is severed from its outer tube distal end 268 into a first portion (balloon portion) and a second portion (outer tube portion), the first portion being blow molded and the second portion being extruded, and the first and second portions being bonded to form a balloon assembly 250a,450a (not shown) substantially identical to the balloon assembly 250. The method mainly comprises the following steps:

Welding process or bonding process: the second portion and the first portion overlap and form a seam area by welding (bonding).

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. 31-32 depict the case where the airbag lip opening lip 289 and the opening lip 229 are not aligned in the axial direction. For example, the first and second portions need not be pre-bonded or welded as a unit and then assembled to the exterior of the hollow sleeve, as long as the distal end of the outer tube and the outer cylindrical surface are completely closed and the areas other than the flow passage are completely closed, and various processes can be easily implemented. 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. A cannula assembly comprising a plicated balloon, comprising a first seal assembly and a second seal assembly, said second seal assembly comprising a lower housing and a hollow cannula connected thereto and extending distally therefrom, said first seal assembly, second seal assembly and hollow cannula comprising an instrument channel in communication and in substantial alignment, characterized in that:

The hollow sleeve comprises an inner cylindrical surface and an outer cylindrical surface and a sleeve wall therebetween; the distal end of the hollow cannula further comprising an open cannula lip comprising an angled cylindrical surface therebetween, the inner cylindrical surface and the angled cylindrical surface defining a cannula angled wall;

the sleeve assembly further comprises an inflatable balloon assembly, a one-way valve assembly for inflating and deflating, and an air flow channel communicating the balloon assembly and the one-way valve assembly;

the balloon assembly comprises a balloon lip and a balloon body connected with the balloon lip, wherein the balloon lip extends distally to form a balloon inclined wall matched with the shape and the size of the sleeve inclined wall; the balloon lip extends towards the proximal end, is connected with the balloon body and is in smooth transition; the air bag body comprises a plurality of folds which are axially or annularly arranged, and after the air bag body is deflated, emptied and folded, the folds are regularly piled up to avoid forming an annular step-shaped abrupt change structure perpendicular to the axis;

the air bag assembly is arranged outside the hollow sleeve, the air bag lip is coated on the outer surface of the sleeve lip, and the air bag inclined wall and the sleeve inclined wall form taper fit; and an annular totally-enclosed taper joint area is fixedly formed between the air sac inclined wall and the sleeve inclined wall so as to connect the air sac lip and the sleeve lip into a whole;

The air bag body comprises an air bag proximal end transition zone, an air bag distal end transition zone and an air bag main body extending between the air bag proximal end transition zone and the air bag distal end transition zone, wherein the air bag proximal end transition zone comprises an equal-diameter corrugated pipe composed of transverse folds, and the air bag main body comprises a variable-diameter corrugated pipe with gradually increased zigzag steps composed of transverse folds from a distal end to a proximal end; and applying external force compression to convert the constant-diameter corrugated pipe into a diastole state, and compressing and attaching the variable-diameter corrugated pipe into a fish scale structure.

2. The cannula assembly of claim 1, wherein: the balloon lip and balloon body have a uniform wall thickness T _a3 T is not less than 0.05mm _a3 ≤0.1mm。

3. The cannula assembly of claim 1, wherein: the air bag assembly further includes an outer sleeve comprising an outer tube proximal end, an outer tube distal end and an outer tube wall extending therebetween, the outer tube distal end and outer cylindrical surface forming a non-fully enclosed seam region, and the outer tube proximal end and outer surface of the valve seat of the outer cylindrical surface and one-way valve assembly being secured to form a fully enclosed proximal seam region, an air flow passage being formed between the outer sleeve and the outer cylindrical surface in communication with the air bag assembly and the one-way valve assembly.

4. The cannula assembly of claim 1, wherein: the fixing mode between the air sac inclined wall and the sleeve inclined wall comprises a welding mode or a glue bonding mode.

5. The cannula assembly of claim 1, wherein: an included angle A between the inclined cylindrical surface and the inner cylindrical surface _lip Wherein A is less than or equal to 3 DEG _lip ≤15°。

6. The cannula assembly of claim 1, wherein: the fixing assembly is fixed outside the body and comprises a fixing pad and a locking piece.

7. A cannula assembly comprising a plicated balloon, comprising a first seal assembly and a second seal assembly, said second seal assembly comprising a lower housing and a hollow cannula connected thereto and extending distally therefrom, said first seal assembly, second seal assembly and hollow cannula comprising an instrument channel in communication and in substantial alignment, characterized in that:

the air bag body comprises an air bag proximal end transition area, an air bag distal end transition area and an air bag main body extending between the air bag proximal end transition area and the air bag distal end transition area; the circumferentially disposed pleats on the balloon body include pleat peaks and pleat valleys and pleat walls extending therebetween, the pleats extending proximally from the distal end, the pleat walls extending proximally from the distal end of the balloon at a transition zone of the distal end of the balloon having progressively greater widths, the pleat walls extending proximally from the distal end of the balloon body having substantially equal widths, and the pleat walls extending proximally from the distal end of the balloon at a transition zone of the proximal end of the balloon having progressively less widths.

8. The cannula assembly of claim 7, wherein: the fold peak forms an acute angle A with the axis at the transition zone of the far end of the air bag _d The method comprises the steps of carrying out a first treatment on the surface of the The fold peak forms an acute angle A with the axis at the transition zone of the proximal end of the air bag _p The method comprises the steps of carrying out a first treatment on the surface of the And A is _d ＜A _p 。

9. The cannula assembly of claim 7, wherein: the balloon lip and balloon body have a uniform wall thickness T _a3 T is not less than 0.05mm _a3 ≤0.1mm。

10. The cannula assembly of claim 9, wherein: the air bag assembly further includes an outer sleeve comprising an outer tube proximal end, an outer tube distal end and an outer tube wall extending therebetween, the outer tube distal end and outer cylindrical surface forming a non-fully enclosed seam region, and the outer tube proximal end and outer surface of the valve seat of the outer cylindrical surface and one-way valve assembly being secured to form a fully enclosed proximal seam region, an air flow passage being formed between the outer sleeve and the outer cylindrical surface in communication with the air bag assembly and the one-way valve assembly.

11. The cannula assembly of claim 8, wherein: the fixing mode between the air sac inclined wall and the sleeve inclined wall comprises a welding mode or a glue bonding mode.

12. The cannula assembly of claim 8, wherein: an included angle A between the inclined cylindrical surface and the inner cylindrical surface _lip Wherein A is less than or equal to 3 DEG _lip ≤15°。

13. The cannula assembly of claim 8, wherein: the fixing assembly is fixed outside the body and comprises a fixing pad and a locking piece.

14. A method of manufacturing a sleeve assembly for a pleated airbag according to claim 1 or 7, wherein: the balloon assembly comprises a first portion and a second portion joined at a distal end of an outer tube thereof, the main steps of which are as follows: