CN109157269B

CN109157269B - Puncture outfit sealing protection device and sealing system

Info

Publication number: CN109157269B
Application number: CN201811282992.6A
Authority: CN
Inventors: 朱莫恕
Original assignee: 5r Med Technology Chengdu Co ltd
Current assignee: 5r Med Technology Chengdu Co ltd
Priority date: 2016-08-02
Filing date: 2016-08-02
Publication date: 2023-05-26
Anticipated expiration: 2036-08-02
Also published as: CN106175846B; CN106175846A; CN109157269A; WO2018024100A1

Abstract

The invention discloses a puncture outfit sealing protection device and a sealing system. The guard includes a proximal opening, a distal end, and a central axis. The distal end includes a plurality of pleats, each of the pleats including a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley. The plurality of pleats are arranged in a dish-shape about a central axis and define a distal aperture, the distal aperture being bordered by a wavy annular line. The wavy annular line is entirely on a cylindrical surface or entirely on a conical surface. The intersection line of any cylindrical surface which takes the central axis as the center of a circle and all folds in the area adjacent to the far-end hole is a complete wavy annular line. The proximal opening of the protective device further includes a boss and a cylindrical wall extending from the proximal end to the distal end. The situation that the protection device is interfered with each other can not occur after the sealing film and the protection device are turned inwards, and the bending accumulation and winding of the protection device and the sealing film can be lightened, so that the friction resistance after the inversion is reduced.

Description

Puncture outfit sealing protection device and sealing system

The application is named as: a pleated puncture outfit sealing system, the application date is: the application number of the product is 2016, 08 and 02: division of the invention patent application of 201610630336.5.

Technical Field

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

Background

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

In hard endoscopic surgery, a stable pneumoperitoneum is often created and maintained to obtain sufficient surgical space. The cannula assembly is typically comprised of a cannula, a housing, a sealing membrane (also known as an instrument seal) and a zero seal (also known as an auto seal). The cannula penetrates from outside the body cavity into the body cavity as a passageway for instruments to enter and exit the body cavity. The housing connects the sleeve, zero seal and sealing membrane into a sealed system. The zero seal typically does not provide a seal to the inserted instrument, but automatically closes and forms a seal when the instrument is removed. The sealing membrane grips the instrument and forms a seal when the instrument is inserted.

In a typical endoscopic procedure, 4 puncture passages are usually established in the patient's abdominal wall, namely 2 small-diameter cannula assemblies (typically 5 mm) and 2 large-diameter cannula assemblies (typically 10-12 mm). Instruments that are typically accessed into the patient via a small inner diameter cannula assembly perform only a secondary operation; one of the large inner diameter sleeve assemblies serves as an endoscope channel; while the other large inner diameter cannula assembly serves as the primary channel for the surgeon to perform the procedure. The primary channel described herein, about 80% of the time, was used with a 5mm instrument; about 20% of the time other large diameter instruments are applied; and the 5mm instrument and the large-diameter instrument need to be frequently switched in the operation. The time for applying the small-diameter instrument is longest, and the sealing reliability is important; the application of large diameter instruments is often a critical stage in surgery (e.g., vascular closure and tissue suturing), where switching convenience and operational comfort are important.

Figures 1 and 2 depict a typical 12mm gauge cannula assembly 700 of the prior art. The ferrule assembly 700 includes a lower housing 710, an upper housing 720 and a sealing membrane 730 sandwiched between the upper and

lower housings

720, 710, a duckbill seal 750. The lower shell 710 includes a central through bore 713 defined by an elongate tube 711. The upper housing 720 includes a proximal bore 723 defined by an inner wall 721. The sealing membrane 730 includes a proximal opening 732, a distal hole 733, a sealing lip 734, a truncated cone sealing wall 735, a flange 736, and an outer floating portion 737. The distal opening 733 is formed by a sealing lip 734. Defining an axis of the sealing lip as 741, defining a transverse plane 742 generally perpendicular to the axis 741; the angle between the generatrix of revolution defining the truncated cone seal wall 735 and said transverse plane 742 is the angle of guidance ANG1.

When a 5mm instrument is inserted, as in fig. 1, it is approximately believed that only the hoop forces generated by deformation of the sealing lip 734 ensure a reliable seal for the instrument. While performing surgery, it is often necessary to operate the instrument from various limiting angles. The 5mm instrument has a large radial clearance space in the 12mm cannula which places the sealing lip 734 radially more stress. The sealing lip 734 should therefore have sufficient hoop force for an inserted 5mm instrument to ensure its sealing reliability.

As shown in FIG. 2, a diameter D is made _i （D _i > 5 mm) cylinder intersects the sealing wall 735 to form a diameter D _i Is shown as intersecting line 738. Those skilled in the art will certainly appreciate that if the insertion diameter is D _i The sealing wall 735 has a greater strain (stress) from the sealing lip 734 to the intersection 738, which is referred to as the region adjacent to the sealing lip (or stress concentration region); while the sealing wall 735 has less strain (stress) from the intersection 738 to the flange 736. Diameter D of insertion instrument _i The boundary ranges of the adjacent areas (stress concentration areas) of the seal lips are different in size. Definition of time D for easy quantization _i The area from the sealing lip 734 to the intersection 738 is the area adjacent to the sealing lip when the maximum diameter of the surgical instrument through the sealing membrane is designed.

As shown in fig. 3, upon insertion of a large diameter instrument (e.g., 12.8 mm), the sealing lip 734 will expand to a suitable size to accommodate the inserted instrument; the sealing wall 735 is divided into a conical wall 735c and a cylindrical wall 735 d; the cylindrical wall 735d wraps around the outer surface of the device, creating a highly concentrated area of wrap for the stress. Defining the intersection of conical wall 735c and cylindrical wall 735d as 738a; when the instrument is removed, the sealing wall 735 returns to its natural state, defining the intersection 738a to rebound to a radius D _x Is not shown in the figures); the intersection 738b is the curved line of demarcation when a large diameter instrument is inserted. An included angle between a rotation generatrix of the conical wall 735c and the transverse plane 742 is defined as ANG2, and ANG2 > ANG1; that is, when a large diameter instrument is inserted, the seal wall 735 rotates and expands about the intersection line of the flange 736 and the seal wall 735. Defines the height of the cylindrical wall 735d as H _a . The H is _a Not constant, the distal hole size is different, the sealing lip size is different, the wall thickness of the sealing wall is different, and factors such as different guide angles or different diameters of the insertion instrument will cause H _a Different.

When the instruments inserted into the sealing membrane are moved during the operation, a large frictional resistance exists between the wrapping area and the inserted instruments. The large friction resistance generally causes the sealing film to turn inwards, the operation comfort is poor, the operation is tired, even the sleeve assembly is fixed on the abdominal wall of a patient, and the like, which affects the usability of the sleeve assembly.

Among the drawbacks caused by the large frictional resistance, the inversion of the sealing film is one of the most serious problems affecting the service performance of the sleeve assembly. As shown in fig. 4, seal membrane inversion is likely to occur when the large diameter instrument is pulled out. The seal wall 735 after inversion is divided into a cylindrical wall 735e, a conical wall 735f, and a conical wall 735g; the cylindrical wall 735e wraps around the outer surface of the device, forming a highly stress concentrated wrap area. Defining the height of the cylindrical wall 735e as H _b Generally H _b Greater than H _a The method comprises the steps of carrying out a first treatment on the surface of the That is, the frictional resistance when the instrument is pulled out is greater than the frictional resistance when the instrument is inserted; this discrepancy affects the surgeon's operating experience and even causes the surgeon to create an illusion. More seriously, the inverted sealing membrane may enter the proximal bore 723, i.e. the sealing membrane may build up between the device and the inner wall 721 causing seizing. Measures for preventing inversion of the sealing film are disclosed in US7112185, US7591802, respectively; these measures can effectively reduce the inversion probability but do not completely solve the inversion problem.

The simplest way to reduce the friction resistance is to use grease to reduce the friction coefficient between the two contact surfaces. But the reliability of this measure is not good. In clinical application, grease is easily separated from the surface of the sealing film and taken away due to long-term repeated scraping of the device with the sealing film and repeated switching of various devices, so that poor lubrication is caused.

A protective sheet against a sealing film is disclosed in US 5342315. The protective sheet can avoid the sharp edge of the instrument from damaging the sealing film, and the friction resistance can be reduced to a certain extent because the friction coefficient of the surface of the protective sheet is smaller than that of the sealing film. But the area adjacent the sealing lip is generally not completely covered by the protective sheet.

In US5827228 a ribbed sealing film is disclosed, i.e. a sealing film having several radially divergent ribs starting from the vicinity of the central hole, which ribs reduce the contact area between the insertion instrument and the sealing film, thereby reducing said frictional resistance. An approximation of the stiffening rib has been disclosed in EP0994740 to have the effect of reducing the contact area and increasing the axial tensile strength of the sealing membrane.

A corrugated sealing membrane is disclosed in US7842014, which is mainly characterized by having a wavy sealing lip and a wavy corrugated sealing body. The fold structure can increase the circumferential perimeter and reduce the hoop tightening force to a certain extent.

Chinese patent application CN101480354a (currently rejected) discloses a sealing film comprising easily deformable grooves, starting from a sealing lip, on the conical surface of which there are several easily deformable grooves; the wall thickness of the easy-to-deform groove is far smaller than that of the conical surface; the inserted large diameter instrument is accommodated primarily by the elongated deformation of the flexible channel.

Although many solutions for reducing the frictional resistance have been disclosed in the prior art, the disclosed solutions have been proposed essentially only from the point of view of a certain factor affecting the frictional resistance, with little or no effect on reducing the frictional resistance. Other drawbacks are introduced in some schemes even by improving one factor. For example, the addition of reinforcing ribs to the sealing film reduces the contact area, but increases the hoop force; for example, the use of the easily deformable groove with the thickness much smaller than the truncated conical surface can lead to the easily deformable groove being easily damaged; for example, if the wavy sealing lip increases the circumferential circumference of the opening of the sealing membrane, thereby sacrificing sealing reliability when a 5mm instrument is applied, if the wavy sealing lip does not increase the circumferential circumference of the opening of the sealing membrane, the wavy sealing lip has lost improvement over the purely circular sealing lip. In summary. Many factors influence the frictional resistance, and the combined action of the factors must be considered from the mechanical and tribological aspects.

The sealing film is generally made of a rubber material such as natural rubber, silicone rubber, isoprene rubber, etc., which has superelasticity and viscoelasticity. Although the mechanical model of the rubber deformation process is complex, the elastic behavior of the rubber can be approximately described by generalized Hooke's law; the viscous behavior is described by newtonian internal friction law. Studies have shown that the main factors affecting the friction force generated by contact of rubber with the instrument include: the friction force is smaller as the friction coefficient of the two contact surfaces is smaller; the better the lubrication condition between the two contact surfaces is, the smaller the friction force is; the smaller the real contact area between the two contact surfaces is, the smaller the friction force is; the smaller the normal pressure between the two contact surfaces, the lower the friction. The present invention combines the above factors and proposes a more complete solution for reducing the frictional resistance between the sealing membrane and the insertion instrument.

In addition to the aforementioned frictional resistance that greatly affects the performance of the cannula assembly, seal film stick-slip is another important factor that affects the performance of the penetrator. The stick-slip, i.e. the relatively static adhesion of the sealing lip of the sealing membrane and its immediate area to the instrument when the instrument is moved axially in the cannula (the friction between the instrument and the sealing membrane is mainly static friction); the phenomenon of relative sliding with the instrument is generated (the friction force between the instrument and the sealing film is mainly dynamic friction force at the moment); and the static friction force is much greater than the dynamic friction force. The static friction and dynamic friction alternate, which results in unstable resistance and unstable movement speed of the instrument in the sealing membrane. Those skilled in the art will appreciate that in minimally invasive surgery, a physician can only access the internal organs of a patient with the instrument and monitor the local extent of the working head of the instrument by means of an endoscopic imaging system. In such a case of limited visual field and tactile blocking, the surgeon generally uses the resistance feedback when moving the instrument as one of the information for determining whether the operation is normal. The sealing film stick-slip affects the comfort of operation, positioning accuracy, and even induces erroneous judgment by doctors.

The stick slip is difficult to avoid completely, but can be reduced during use of the cannula assembly. Studies have shown that the stick-slip is affected by two main factors: firstly, the smaller the difference value between the maximum static friction force and the dynamic friction force is, the weaker the stick-slip is; and secondly, the greater the axial tensile rigidity of the sealing film is, the weaker the stick-slip is. The method has the advantages that the excessive hoop tightening force between the sealing film and the instrument is avoided, the real contact area between the sealing film and the instrument is reduced, the good lubrication between the sealing film and the instrument is kept, and the difference value between the maximum static friction force and the dynamic friction force can be reduced, so that the stick-slip is reduced. And meanwhile, the axial tensile rigidity of the sealing film is increased, and the sticking and sliding phenomena are also reduced. The invention also provides a measure for improving the stick-slip.

In view of the foregoing, there is no sleeve assembly that effectively solves the foregoing problems.

Disclosure of Invention

It is therefore an object of the present invention to provide a sealing system which reduces frictional resistance and improves stick-slip when applying large diameter instruments, while ensuring a reliable seal for inserted 5mm instruments. The sealing system comprises a sealing membrane and a first protection device; the sealing film is connected with the first protection device; the sealing membrane comprising a proximal opening and a distal aperture, and a sealing wall extending from the distal aperture to the proximal end, the sealing wall having a proximal face and a distal face, the distal aperture being formed by a sealing lip; the first protective device includes a proximal opening and a distal opening and a protective wall extending from the distal opening to the proximal end.

As mentioned in the background, the wrapping area formed by the sealing lip and its immediate area during insertion of large diameter instruments is the source of greater frictional resistance. To reduce the frictional resistance, the reduction of the radial stress between the device and the sealing film, the reduction of the wrapping area between the device and the sealing film and the reduction of the real contact area between the device and the sealing film should be comprehensively considered. It will be appreciated by those skilled in the art that increasing the circumferential perimeter reduces the circumferential strain (stress) and thus the radial strain (stress) as known from the broad hooke's law and poisson effect. It should be noted that the strain (stress) of the sealing lip cannot be reduced by increasing the circumferential perimeter, which would result in reduced seal reliability when a 5mm instrument is applied. The circumferential perimeter of the adjacent sealing lip region should be rapidly increased due to the high concentration of stresses in the adjacent sealing lip region when large diameter instruments are applied; for areas other than the immediate area of the sealing lip, no provision may be made to increase the circumferential perimeter due to less strain (stress). In addition, the circumferential perimeter is increased, and meanwhile, the axial tensile rigidity of the adjacent area of the sealing lip is increased, and good lubrication is kept (the difference between the maximum static friction force and the dynamic friction force is reduced), so that the stick-slip of the adjacent area of the sealing lip is improved.

In one aspect of the invention, the sealing wall of the sealing film comprises a plurality of pleats circumscribing the sealing lip and extending laterally outwardly, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley, and the pleats being arranged in a dished pattern about the sealing lip as a whole. The protective wall of the first protective means comprises the same number of folds matching the shape and size of the sealing wall. The boundary of the distal opening of the first protection means is formed by a wavy loop line, which is on the same cylindrical surface or on the same conical surface entirely.

In an alternative embodiment, the seal film has a pleat depth that increases progressively as the pleats extend laterally outward. In yet another aspect, the seal membrane has a pleat depth that remains constant from pleat to pleat depth as the pleats extend laterally outward. In yet another aspect, the seal membrane has a pleat depth that gradually decreases as the pleats extend laterally outward. In yet another aspect, the sealing wall comprises 10 pleats.

In an alternative embodiment, the protective wall comprises a plurality of cut-out grooves in the vicinity of the distal opening of the first protective means. In yet another aspect, the proximal end of the first guard further comprises a boss and a cylindrical wall, as well as, each pleat of the first guard comprises a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley; the pleats of the first protection device extend laterally outwardly from the distal opening thereof and the pleat valleys thereof intersect the cylindrical wall extension, while the pleat peaks thereof and adjacent pleat walls thereof are cantilevered from intersecting the cylindrical wall.

In yet another alternative, the sealing membrane further comprises a flange and an inner groove, the first protection means comprising a boss of a shape and size matching the inner groove, the boss being embedded in the inner groove such that the protection wall is proximate to the proximal face of the sealing wall, the first protection means moving or floating with the sealing membrane. In yet another aspect, the sealing system includes a sealing membrane, a first protection device, a first securing ring, and a second securing ring; the first and second securing rings secure the first protective device and the sealing membrane together such that a protective wall of the first protective device is proximate a proximal face of the sealing wall, the protective device moving or floating with the sealing membrane. In yet another aspect, the sealing system includes a sealing membrane, a first protection device, a second protection device; the second protection means comprises the same number of folds matching the shape and size of the sealing wall. The first protection device is adhered to the proximal end of the sealing wall, and the second protection device is adhered to the distal end of the sealing wall, so that the protection wall of the protection device is close to the proximal end face of the sealing wall, and the second protection wall is close to the distal end face of the sealing wall. The first and second protection devices move or float with the sealing film.

In yet another alternative, the sealing membrane includes a flange and an outer floating portion extending from the flange to the proximal opening, the outer floating portion having at least one transverse fold. The sealing system further includes an upper housing and an upper cover, the proximal opening of the sealing membrane is sandwiched between the upper housing and the upper cover, and the sealing membrane is movable or floatable within a seal cartridge formed by the upper housing and the upper cover during the float portion.

Another object of the present invention is to provide a puncture outfit. The puncture outfit comprises any one of the sealing systems, and further comprises a sleeve, a duckbill seal and a lower cover; the duckbill seal is secured between the sleeve and the lower cap to form a first seal assembly; the sealing system and the first sealing component are fixed together through a quick locking structure.

The above and other objects, features and advantages of the present invention will become more apparent when taken in conjunction with the accompanying drawings and detailed description.

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 simulated deformation of a prior art cannula assembly as it is inserted into a 5mm instrument;

fig. 2 is a detailed view of a sealing film 730 of the prior art;

FIG. 3 is a simulated deformation of a prior art cannula assembly as it is inserted into a 12.8mm instrument;

FIG. 4 is a simulated deformation of the prior art cannula assembly as it is withdrawn from a 12.8mm instrument;

FIG. 5 is a perspective, partial cross-sectional view of the sleeve assembly of the present invention;

FIG. 6 is a top perspective view of the sealing membrane assembly of the sleeve assembly of FIG. 5;

FIG. 7 is a longitudinal cross-section of the sealing membrane assembly shown in FIG. 6;

FIG. 8 is a perspective view of the sealing membrane of FIG. 6 with the proximal end and floating portion omitted;

FIG. 9 is a reverse perspective view of the sealing membrane of FIG. 8;

FIG. 10 is a cross-sectional view 10-10 of the sealing film of FIG. 9;

FIG. 11 is a cross-sectional view 11-11 of the sealing film of FIG. 9;

FIGS. 12-13 are graphs of the sealing film of FIG. 9 after separation by circumferential cutting;

FIG. 14 is a perspective view of the protective device of FIG. 6;

FIG. 15 is a reverse perspective view of the protective device of FIG. 14;

FIG. 16 is a view, in section, of the protective device of FIG. 15 taken along section 16-16;

FIG. 17 is a cross-sectional view of the protective device 17-17 of FIG. 15;

FIG. 18 is an exploded view of a second embodiment of a sealing membrane assembly of the invention;

FIG. 19 is a partial cross-sectional view of the sealing membrane assembly of FIG. 18;

FIG. 20 is a perspective view of a sealing membrane in the sealing membrane assembly shown in FIG. 18;

FIG. 21 is a reverse perspective view of the sealing membrane of FIG. 20;

FIG. 22 is a cross-sectional view of the sealing film 21-21 shown in FIG. 21;

FIG. 23 is a sectional view 23-23 of the sealing film shown in FIG. 21;

FIG. 24 is a perspective view of a protective device in the sealing membrane assembly of FIG. 18;

FIG. 25 is a partial perspective cross-sectional view of the protective device of FIG. 24;

FIG. 26 is a cross-sectional view, 26-26, of the protective device of FIG. 24;

FIG. 27 is an exploded view of a sealing membrane assembly according to a third embodiment of the invention;

FIG. 28 is a longitudinal cross-sectional view of the sealing membrane assembly of FIG. 27;

FIG. 29 is a perspective view of the protective device in the sealing membrane assembly of FIG. 27;

FIG. 30 is an enlarged view of a portion of the protective device of FIG. 29;

FIG. 31 is a cross-sectional view of the protective device 31-31 of FIG. 29;

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

Description of the embodiments

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.

Fig. 5 depicts the overall structure of the puncture instrument. A typical penetrator includes a needle 10 (not shown) and a cannula assembly 20. The cannula assembly 20 has an open proximal end 192 and an open distal end 31. In a typical application, the needle 10 is passed through the cannula assembly 20 and then passed together through the abdominal wall through the percutaneous opening into the body cavity. Once inside the body cavity, the needle 10 is removed and the cannula assembly 20 is left as a passageway for instruments into and out of the body cavity. The proximal end 192 is outside the patient and the distal end 31 is inside the patient. A preferred sleeve assembly 20 may be divided into a first seal assembly 100 and a second seal assembly 200. The clamping groove 39 of the assembly 100 and the clamping hook 112 of the assembly 200 are matched and fastened. The cooperation of the hook 112 and the slot 39 is a quick-locking structure that can be quickly detached by one hand. This is mainly for the convenience of removing tissue or foreign matter from the patient during surgery. There are a number of implementations of the snap lock connection between the

assemblies

100 and 200. In addition to the structures shown in this embodiment, threaded connections, rotary snaps, or other quick lock structures may be employed. Alternatively, the assembly 100 and the assembly 200 may be designed in a structure that is not quickly detachable.

Fig. 5 depicts the composition and assembly relationship of the first seal assembly 100. The lower housing 30 includes an elongated tube 32 defining a cannula 33 extending through the distal end 31 and connected to a housing 34. The lower housing 30 has an inner wall 36 supporting the duckbill seal and an air valve mounting hole 37 in communication with the inner wall. Valve element 82 is mounted in valve body 80 and together in mounting bore 37. The flange 56 of the duckbill seal 50 is sandwiched between the inner wall 36 and the lower cap 60. The fixing manner between the lower cover 60 and the lower housing 30 is various, and may be interference fit, ultrasonic welding, gluing, fastening, etc. The 4 mounting posts 68 of the lower cap 60 in this embodiment are an interference fit with the 4 mounting holes 38 of the lower housing 30, which interference fit places the duckbill seal 50 in compression. The sleeve 32, inner wall 36, duckbill seal 50, valve body 80 and valve core 82 together form a first chamber. In this embodiment, the duckbill seal 50 is a single slit, but other types of closed valves may be used, including flapper valves, multi-slit duckbill valves. When an external instrument penetrates the duckbill seal 50, its duckbill 53 can open, but it generally does not provide a complete seal against the instrument. When the instrument is removed, the duckbill 53 automatically closes, thereby preventing fluid in the first chamber from leaking outside.

Fig. 5 depicts the composition and assembly relationship of the second seal assembly 200. The sealing membrane assembly 180 is sandwiched between the upper cover 110 and the upper housing 190. The proximal end 132 of the sealing membrane assembly 180 is secured between the inner ring 116 of the upper cap 110 and the inner ring 196 of the upper housing 190. The upper housing 190 and the upper cover 110 may be fixed in various manners, such as interference fit, ultrasonic welding, adhesive bonding, and fastening. The embodiment shows that the upper case 190 and the upper cover 110 are connected by ultrasonic welding and fixed together by a housing 191. This fixation places the proximal end 132 of the sealing membrane assembly 180 in compression. The central aperture 113 of the upper cap 110, the inner ring 116 and the sealing membrane assembly 180 together form a second chamber.

Fig. 6-7 depict the composition and assembly relationship of the sealing membrane assembly 180. The sealing membrane assembly 180 includes a sealing membrane 130 and a protective device 150. The sealing membrane 130 includes a proximal opening 132, a distal aperture 133, and a sealing wall extending proximally from the distal end, the sealing wall having a proximal face and a distal face. The distal aperture 133 is formed by a sealing lip 134 for receiving an inserted instrument and creating a hermetic seal. The sealing membrane 130 further comprises a flange 136, and the sealing wall 135 has one end connected to the sealing lip 134 and the other end connected to an extended cylindrical wall 139 of the flange 136. The floating portion 137 is connected to the flange 136 at one end and to the proximal opening 132 at the other end. The flange 136 has an annular groove 138 for mounting the protector 150. The float portion 137 includes one or more radial (lateral) pleats to enable the entire sealing membrane assembly 180 to move or float within the assembly 200. The guard 150 includes a proximal end 152 and a distal end 154 and a cylindrical wall 159 extending from the proximal end to the distal end. The proximal end 152 includes a boss 158. As previously described, the cylindrical wall 159 and boss 158 are shaped and sized to mate with the cylindrical wall 139 and annular groove 138 such that the protective device 150 is embedded in the sealing membrane 130. The protector 150 is sized and shaped to fit inside the sealing membrane 130 without interfering with the sealing membrane 130. The protector 140 moves or floats with the sealing membrane 130 to protect the central portion of the sealing membrane 130 from perforation or tearing by the sharp edges of the inserted surgical instrument. The sealing film 130 is typically made of an elastic material such as natural rubber, silica gel, isoprene rubber, etc.; the protective device 150 is typically made of a rigid or semi-rigid material such as thermoplastic elastomer, polypropylene, polyethylene, and the like.

Fig. 8-11 depict the sealing film 130 structure in greater detail. For simplicity of illustration, the outer floating portion and proximal end are not shown in fig. 8-11. A central axis 148 defining the sealing membrane 130 and a transverse plane 149 substantially perpendicular to the central axis 148. The sealing wall 135 includes a plurality of pleats 140, the plurality of pleats 140 being arranged in a generally disk-like fashion about the axis 148. The plurality of pleats 140 circumscribe the sealing lip 134 forming an annular wavy line 141. The annular wavy line 141 defines the transition region 134a. The annular wavy line 141 is formed in such a manner that its annular wave is substantially on a cylindrical surface. Any cylindrical surface is taken as an axis 148 as an axis to intersect the folds, and the intersection line is a complete annular wavy line; or any cylindrical surface centered at least about axis 148, intersects the corrugations in the immediate vicinity of the sealing lip 134, with the intersection being a complete annular wavy line. Which is referred to herein as a cylindrical wave ring. The sealing wall 135 can be seen as a stack of numerous complete cylindrical wave rings of progressively increasing diameter. The present example contains 10 pleats, however more or fewer pleats may be used.

Each of the pleats 140 includes pleat walls 143 extending between pleat peaks 142 and pleat valleys 144. The pleats 140 extend laterally outwardly from the sealing lip and intersect the cylindrical wall 139 to form an annular wavy line 145, the annular wavy line 145 defining a triangular transition area 139a. And the depth of the pleats 150 remains substantially unchanged as the pleats extend laterally outward; the depth of the pleat walls may be measured as the distance between the pleat peaks and the pleat valleys along the axis 148. The pleat peaks 142 are defined as α and the pleat valleys 144 are defined as β with respect to the transverse plane 149. The pleats 140 are arranged in a dished overall shape and α=β=0°, however it cannot be understood that the α angle or β must be zero, and when α or β is small, for example 0 ° +.ltoreq.α.ltoreq.15°, 0+.ltoreq.β.ltoreq.15°, the pleats as a whole still appear dished, the shape of which is still significantly different from the frustoconical shape described in the prior art.

As shown in fig. 12-13, a cylindrical surface cut surface M is formed along the outer circumferential side wall of the seal lip 134 with the axis 148 as the rotation axis ₁ (not shown) separates the sealing membrane 130 into a lip portion 146 (fig. 12) and an outer portion 147 (fig. 13). The cylindrical cutting surface M ₁ Intersecting the sealed wall 135 to form annular

wavy lines

141b,141c; the annular

wavy lines

141b and 141c define a cross section 146. With reference to fig. 12-13, it is apparent thatPerimeter L of intersection line 141c (141 b) ₁ Much larger than the perimeter of the sealing lip 134, i.e., the corrugations act to increase the circumferential perimeter of the adjacent region of the sealing lip, helping to reduce the hoop forces generated in the adjacent region of the sealing lip during insertion of an external device, thereby reducing the frictional resistance between the device and the sealing membrane.

The pleated walls 143 act like the ribs described in the background, and all of the pleated walls 143 together reinforce the axial tensile stiffness in the immediate vicinity of the seal lip; and the fold wall 143 does not increase the circumferential stiffness while increasing the axial tensile stiffness, so that the circumferential tightening force is not increased while increasing the axial stiffness, and the stick-slip described in the background can be effectively reduced. In this example 20 of said pleated walls 143 are included, however more or fewer side walls may also serve to increase the axial tensile stiffness.

Fig. 14-17 depict the structure of the protective device 150 in greater detail. Defining a central axis 168 of the guard and a transverse plane 169 that is generally perpendicular to the central axis 168. The distal end 154 includes a plurality of pleats 160, the plurality of pleats 160 being generally disk-shaped about the axis 168 and defining a central throughbore 153. The central through hole 153 is defined by a complete annular wavy line 161. The annular wavy line 161 is formed in such a manner that its annular wave is substantially on a cylindrical surface. Any cylindrical surface is taken as an axis 168 as an axis to intersect the folds, and the intersection line is a complete annular wavy line; or any cylindrical surface centered on at least axis 168 intersects corrugations in the vicinity of the central opening 161, the intersection being a complete annular wavy line. Which is referred to herein as a cylindrical wave ring. The distal end 154 may be seen as a stack of numerous complete cylindrical wave rings of progressively increasing diameter. Generally, the circumference L of any cylindrical wave ring ₂ Larger than the outer perimeter of the largest diameter instrument that is designed to pass. For example, the radius of the largest instrument designed to pass through is R ₂ L is then ₂ ＞2*π*R ₂ (where pi=3.14) this example contains 10 pleats, however more or fewer pleats may be employed.

Each of the pleats 160 includes pleat walls 163 extending between pleat peaks 162 and pleat valleys 164. The pleats 160 extend laterally outwardly from an annular wavy line 161 and intersect the cylindrical wall 159 to form an annular wavy line 165, and the annular wavy line 165 defines a transition zone 159a. And the depth of the pleats 160 remains substantially unchanged as the pleats extend laterally outward; the depth of the pleat walls may be measured as the distance between the pleat peaks and the pleat valleys along axis 168. The pleat peaks 162 are defined as having an angle γ with the transverse plane 169 and the pleat valleys 164 are defined as having an angle θ with the transverse plane 169.

When a large-diameter instrument is inserted into the sealing membrane assembly 180 and moved, a large frictional resistance is generated between the sealing membrane 130 and the inserted instrument. As mentioned in the background, the main methods of reducing the frictional resistance include reducing the hoop force and reducing the actual contact area between the instrument and the sealing membrane. The method for reducing the hoop force mainly comprises the steps of reducing the wall thickness of the sealing film and increasing the circumferential perimeter of the adjacent area of the sealing lip. In the sealing film 730, the wall thickness of the truncated cone sealing wall 735 is typically 0.5 to 0.8mm. Reducing the wall thickness of the sealing wall 735 helps to reduce the hoop force, however, it is generally not possible to reduce the wall thickness. First, the reduced wall thickness results in the sealing membrane 730 being easily pierced or torn by an externally inserted instrument; second, decreasing the wall thickness reduces the axial tensile stiffness of the sealing wall 735, potentially resulting in more pronounced stick-slip as described in the background.

A pleated sealing membrane is disclosed in US7789861 and is primarily characterized by pleats extending laterally outwardly from the sealing lip and increasing in depth. Advantageously, the pleats help reduce hoop stress when inserting large diameter instruments, thereby reducing friction between the surgical instrument and the sealing membrane. Reducing the hoop forces relative to a wrinkle-free design facilitates the use of thicker corrugated walls while providing the same or less pulling force.

US7988671 discloses a pleated unitary sealing membrane protector comprising an integral seamless frustoconical protective cover; the protective cover is composed of a plurality of folds with peaks and valleys; the protective cover prevents both the external insertion instrument from damaging the sealing membrane and the sealing membrane from turning inwards. Although examples are disclosed in US7988671, these examples share two common features: one is that the folds are entirely seamless, and the other is that the folds are entirely frustoconical.

Referring to fig. 6-7, in one embodiment, the sealing membrane 130 and the protection device 150 have the same number of pleats; the shape and size of the pleats 140 match the shape and size of the pleats 160. In yet another alternative, the seal wall 135 formed by the pleats 140 and the distal end 154 formed by the pleats 160 are generally disk-shaped.

Referring to fig. 6-7, when the

pleats

140 and 160 are the same number of pleats, are matched in shape and size, and the sealing wall 135 and distal end 154 are generally dished, little or no material is exposed from the sealing wall 135 beyond the distal end 154 coverage area, which may be more effective in preventing an external insertion instrument from puncturing or tearing the sealing membrane. Thinner sealing membranes may be used to help reduce the hoop forces generated by the sealing membrane when inserting large diameter instruments. In one design, the wall thickness of the sealing wall 135 is 0.35mm to 0.50mm. As previously described, the pleated walls 143 act like the ribs described in the background, and all of the pleated walls 143 together reinforce the axial tensile stiffness in the immediate vicinity of the sealing lip, thus reducing the wall thickness of the sealing wall 135 without causing its axial tensile stiffness to be too small and thus stick-slip to be more severe.

Referring to fig. 6-7 in combination with fig. 12-13, when a large diameter instrument is inserted into the sealing membrane assembly 180, the sealing lip 134 and its transition region 134a undergo an elongation deformation, expanding to a size suitable to accommodate the inserted large diameter instrument; the folds in the adjacent region of the sealing lip 134 relax and create localized bends forming a wrapped region around the outer surface of the instrument; the pleats 150 rotate and relax entirely about the transition region 139a in a direction away from the axis 148. Likewise, the folds 160 rotate and relax in a direction away from the axis about their transition region 159a as a whole. When the instrument is withdrawn from the sealing membrane assembly 180, which in some cases results in the sealing membrane and the protection device being turned in, when the diameter of the cylindrical wall 159 is sufficiently large to reserve sufficient turned in space, only the momentary packing of the turned in sealing membrane and protection device is bent to cause a rapid increase in resistance, and when the instrument is continued to be withdrawn outwardly, the pleats 160 are rotated inwardly about their transition areas 159a to a proper size. When the distal end 154 is dished, the distal end 154 is turned inside out without continuing to bend and accumulate between the sealing membrane and the instrument, without creating a build-up, entanglement, or even blocking of the sealing membrane, thereby improving the operational comfort of the sealing membrane assembly 180 after inversion and preventing the sealing membrane from being damaged.

Theoretical analysis and related studies have shown that reducing the values of α, β described above advantageously reduces the length of the wrapped region formed in the vicinity of the sealing lip when large diameter instruments are inserted. The dished seal wall 135, wherein 0.ltoreq.α.ltoreq.15 °, 0.ltoreq.β.ltoreq.15°, helps to reduce the packing region, i.e. helps to reduce the true contact area of the instrument with the seal membrane, thus enabling a reduction of the frictional resistance.

Fig. 18-19 depict the composition and assembly relationship of a sealing membrane assembly 290 in accordance with a second embodiment of the present invention. The sealing membrane assembly 290 includes a sealing membrane 230, a protection device 250, an outer floating portion 270, a lower retaining ring 220, and an upper retaining ring 280. The sealing membrane 230, the protection device 250, and the outer floating portion 270 are sequentially stacked and sandwiched between the lower and upper fixing rings 220 and 280. And the post 221 of the lower retaining ring 220 is aligned with corresponding holes in other components of the assembly 290. The post 221 is an interference fit with the bore 281 of the upper retaining ring 280, thereby placing the entire sealing membrane assembly 290 in compression.

Fig. 20-23 depict the structure and composition of the sealing membrane 230 in more detail. The sealing membrane 230 includes a proximal opening 232, a distal aperture 233, and a sealing wall extending proximally from the distal end, the sealing wall having a proximal face and a distal face. The distal aperture 233 is formed by a sealing lip 234 for receiving an inserted instrument and creating a hermetic seal. The proximal opening 232 includes a flange 236, and a sealing wall 235 has one end connected to the sealing lip 234 and the other end connected to the flange 236. Defining a central axis 248 of the sealing membrane 230 and a transverse plane 249 that is generally perpendicular to the central axis 248. The sealing wall 235 includes a plurality of pleats 240, the plurality of pleats 240 being arranged in a generally disk-like fashion about the axis 248. The plurality of pleats 240 circumscribe the sealing lip 234 forming an annular wavy line 241. The annular wavy line 241 defines a transition region 246, the transition region 246 extending obliquely from the distal end to the proximal end and progressively increasing in distance from the axis 248. The annular wavy line 241 is formed in such a manner that the annular wavy line is substantially on a conical surface. Any cylindrical surface centered on axis 148 intersects the pleats in the immediate vicinity of the seal lip 134 (not intersecting the transition region), the intersection of which is a complete annular wavy line. Which is referred to herein as a cylindrical wave ring. The sealing wall 135 can be seen as a stack of numerous complete cylindrical wave rings of progressively increasing diameter. The present example contains 10 pleats, however more or fewer pleats may be used.

Each of the pleats 240 includes pleat walls 243 extending between pleat peaks 242 and pleat valleys 244. The pleats 240 extend laterally outwardly from the seal lip and intersect the flange 236 to form an annular wavy line 245, the annular wavy line 245 defining a transition region 247. And the depth of the pleats 240 remains substantially unchanged as the pleats extend laterally outward; the depth of the pleat walls may be measured as the distance between the pleat peaks and the pleat valleys along the axis 248. The corrugation hills 242 are defined at an angle kappa to the transverse plane 249 and the corrugation valleys 244 are defined at an angle lambda to the transverse plane 249. The pleats 240 are arranged in a dished overall shape and kappa=λ=0°, however it cannot be understood that the kappa angle or λ must be zero, and when kappa or λ is small, for example 0 ° -15 °, the pleat overall still exhibits a dished shape, the shape of which is still significantly different from the frustoconical shape described in the prior art.

Fig. 24-26 depict the structure of the protective device 250 in greater detail. The guard 250 includes a proximal end 252 and a distal end 254. The proximal end 252 includes a flange 256. Defining a central axis 268 of the guard and a transverse plane 269 generally perpendicular to the central axis 268. The distal end 254 includes a plurality of pleats 260, a plurality of the pleats 260 are generally disk-shaped about the axis 268 and define a central throughbore 253. The central through hole 253 is defined by a complete annular wavy line 261. The annular wavy line 261 is formed in such a manner that its annular wave is substantially on a conical surface. Any cylindrical surface taking the axis 268 as the axis intersects the folds, and the intersection line is a complete annular wavy line; or any cylindrical surface centered at least on axis 268 intersects the corrugations in the vicinity of the central through hole 253, with the intersection being a complete annular wavy line. Which is referred to herein as a cylindrical wave ring. The distal end 254 can be seen as a stack of numerous complete cylindrical wave rings of progressively increasing diameter. Generally, the circumference L of any cylindrical wave ring ₃ Larger than the outer perimeter of the largest diameter instrument that is designed to pass. For example, the radius of the largest instrument designed to pass through is R ₃ L is then ₃ ＞2*π*R ₃ (where pi=3.14) this example contains 10 pleats, however more or fewer pleats may be employed.

Each of the pleats 260 includes pleat walls 263 extending between pleat peaks 262 and pleat valleys 264. The pleats 260 extend laterally outward from an annular wavy line 261 and the pleat 260 partially intersects the extending wall 258 of the flange 256. A plurality of cut-out slots 265 are included between the pleat 260 and the extended wall 258, the plurality of cut-out slots 265 cutting apart the pleat 260 and the extended wall 258, thereby forming a plurality of ribs 266 connecting the pleat 260 and the extended wall 258. In this example, the pleat peaks 262 and pleat walls 263 are severed by 10 severing slots 265 so that they do not intersect the extension wall 258, while the pleat valleys 264 are connected to the extension wall 258 by 10 ribs 266. It will be appreciated by those skilled in the art that the protector 150, when its pleats 160 are relaxed either laterally or laterally, the pleats rotate about the transition region of the pleats and the cylindrical wall. However, the moment arm of rotation of the corrugation peaks 162 and corrugation valleys 164 is not consistent, thus adding additional deformation force. The protective device 250, however, has substantially equal moment arms of rotation when its pleats 260 are relaxed laterally or medially about the intersection of the ribs 266 and the extension wall 258, thereby minimizing additional deformation forces.

18-19, in one embodiment, the sealing membrane 230 and the protective device 250 have the same number of pleats; the shape and size of the pleats 240 match the shape and size of the pleats 260. In yet another alternative, the seal wall 235 formed by the pleat 240 and the distal end 254 formed by the pleat 260 are generally dish-shaped. When the number of

pleats

240 and 260 are the same, the shape and size are matched, and the sealing wall 235 and distal end 254 are generally dished, there is little or no material exposed from the sealing wall 235 beyond the area covered by the distal end 254, which may be more effective in preventing an external insertion instrument from puncturing or tearing the sealing membrane. The gradual increase in the spacing of the transition region 246, which in this example extends obliquely from the distal end to the proximal end and from the axis 248, helps reduce the actual contact area between the instrument and the sealing membrane when inserting large diameter instruments; while the cut-out 265 helps to reduce the tension forces of the overall inflation of the protective device 250.

Fig. 26-27 depict the composition and assembly relationship of the sealing membrane assembly 390. The seal film assembly 390 includes a seal film 330, a protective device 350 and a protective device 370. The sealing membrane 330 includes a proximal opening 332, a distal aperture 333, and a sealing wall extending proximally from the distal end, the sealing wall having a proximal face and a distal face. The distal aperture 333 is formed by a sealing lip 334. The sealing membrane 330 further comprises a flange 336, and the sealing wall 335 is connected to the sealing lip 334 at one end and to the flange 336 at the other end. The float portion 337 is connected at one end to the flange 336 and at the other end to the proximal opening 332. The float portion 337 includes one or more radial (transverse) pleats. The protective device 350 includes a proximal end 352 and a distal end 354 and a plurality of pleats 360. The proximal end 352 includes a plurality of ribs 356. The protector 350 is sized and shaped to fit inside the sealing membrane 330 without interfering with the sealing membrane 330. The ribs 356 of the guard 350 are bonded to the proximal face of the sealing membrane such that the guard 350 moves or floats with the sealing membrane 330 for protecting the central portion of the sealing membrane 130 from perforation or tearing by the sharp edges of the inserted surgical instrument. The protector 370 has a proximal end 372 and a distal end 374 and a plurality of pleats 380, the protector 370 being sized and shaped to fit outside the sealing membrane 330 without interfering with the sealing membrane 330, the protector 370 being adhered to the distal face of the sealing membrane 330. Those skilled in the art will appreciate that the protective device 370 and the sealing membrane 330 need not be completely bonded, such as by only partially bonding the proximal end 372 to the sealing membrane 330.

Defining a central axis 348 of the sealing membrane 330, the sealing wall 335 includes a plurality of pleats 340, the plurality of pleats 340 being arranged in a generally disk-like fashion about the axis 348. The plurality of pleats 340 circumscribe the sealing lip 334 forming an annular wavy line 341. The annular wavy line 341 defines a transition region 346, the transition region 346 extending obliquely from the distal end to the proximal end and progressively increasing in distance from the axis 348. Each of the pleats 340 includes pleat walls 343 extending between pleat peaks 342 and pleat valleys 344. The pleats 340 extend laterally outwardly from the annular wavy line 341 and the depth of the pleats decreases gradually; the depth of the pleat walls may be measured as the distance between the pleat peaks and the pleat valleys along the axis 348.

The protector 350 has pleats 360 that match the pleats 340, the plurality of pleats 360 being arranged in a generally disk-like fashion and defining a central throughbore 353, more particularly defined by an annular wavy line 361. Each of the pleats 360 includes pleat walls 363 extending between pleat peaks 362 and pleat valleys 364. The pleats 360 extend laterally outwardly from the annular wavy line 361 and the depth of the pleats decreases gradually. Likewise, the protector 370 has folds 380 that are the same or similar to the protector 350. The pleats 380 are generally disk-shaped and define a central throughbore 373, more particularly, defined by an annular wavy line 381. Each of the pleats 380 includes pleat walls 383 extending between pleat peaks 382 and pleat valleys 384. The pleats 380 extend laterally outwardly from the annular wavy line 381 and the depth of the pleats decreases gradually.

Fig. 28-31 depict the structure and composition of the protective device 350 in more detail. In an alternative embodiment, the pleat peaks 352 include cut-out grooves 366 in the vicinity of the central throughbore 353, the cut-out grooves 366 cutting out the pleats 360 from the pleat peaks 352 in the vicinity of the central throughbore 353. The cut-off slot 366 can be injection molded directly with the protective device 350 with a slot width as small as possible; the cutting slot 366 may also be formed by a secondary process, such as direct cutting on the basis of the protective device 350, the width of the cutting slot 366 being approximately zero. Although in this example in the vicinity of the through-hole 353, all of the pleat peaks comprise cut-out slots 366; however, the corrugation peaks and corrugation valleys may also include cut-out slots 366, or a portion of the corrugation valleys may include cut-out slots 366; or a portion of the pleat peaks comprise cut-out slots 366.

Typically, the protective device 350 is made of a semi-rigid material; or made of a rigid material but exhibiting semi-rigidity due to its thin wall thickness. And the sealing film 330 is typically made of an elastic material such as silicone rubber, natural rubber, isoprene rubber, etc. When a large diameter instrument is inserted, the sealing membrane lip 334 expands to a size suitable to accommodate the inserted instrument, and all folds of the protector 350 also relax to a size sufficient to accommodate the inserted instrument. It will be appreciated by those skilled in the art that because the protective device 350 is semi-rigid, its folds typically do not fully relax; i.e. the protector 350 after diastole, still presents a small annular wave. If the annular wave of the protector 350 approaches the sealing lip after relaxation, air leakage or unreliable sealing is easily caused; whereas if the post-diastole annular wave is far enough from the sealing lip to ensure its sealing reliability, it necessarily results in more of the sealing wall of the sealing membrane 350 being uncovered, increasing the risk of puncture or tearing, and to some extent increasing the actual contact area of the instrument with the sealing membrane, thereby increasing frictional resistance.

Taking the protection device 350 as an example, when an external instrument is inserted, such as a titanium clip, because the width of the severing slot 366 is much smaller than the width of the working edge of the inserted titanium clip, and because the protection device comprises a plurality of folds, the working edge of the titanium clip first contacts the folds of the protection device and presses to force the folds to partially relax; the severing slot 366 does not generally enlarge but rather overlaps the material and still prevents the working edge of the titanium clamp from contacting the sealing wall covered by the protective device 350. When the titanium clamp is fully inserted into the sealing membrane assembly, the cutting groove 366 again plays a role of reducing annular waves in the vicinity of the through hole after the relaxation of the protecting device, so that the sealing wall area of the protecting device exposed by design can be reduced, the probability of damaging the sealing membrane is reduced, and the overall tension and the friction resistance generated by movement of the instrument in the sealing membrane can be reduced to a certain extent. In addition, because the guard 350 is semi-rigid, if the immediate area of the central throughbore 353 is entirely seamless, the circumference of the annular wavy line 361 must be greater than the outer circumference of the largest diameter instrument that is designed to be inserted. When the proximal region of the central throughbore 353 includes a plurality of cut-out slots 366, then the desired circumference of the annular wave need not be greater than the outer circumference of the largest diameter instrument for which insertion is designed. It is thus possible to reduce the size of the wrinkles or the number of the wrinkles, thereby simplifying the mold and providing processing efficiency.

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. For example, the present invention does not show cases involving folds of increasing depth, however, one of ordinary skill will appreciate that a plurality of dished-like folds of increasing depth may be employed when the angle of the fold peaks or valleys relative to the transverse plane is small. For example, the present invention shows cases that each include 10 pleats, however, more or fewer pleats may be used. For example, changing the chamfer at the corrugation peak or corrugation valley may change the wall thickness at the corrugation peak or corrugation valley. For example, in the illustrated example of the invention, the pleats have an approximately triangular cross-section, but may also be approximately rectangular or approximately trapezoidal. 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 puncture outfit seal protection device comprising a first protection device comprising a proximal opening and a distal opening and a protection wall extending from the distal opening to the proximal end, characterized in that: the sealing film is connected with the first protection device; the sealing membrane comprising a proximal opening and a distal aperture, and a sealing wall extending from the distal aperture to the proximal end, the sealing wall having a proximal face and a distal face, the distal aperture being formed by a sealing lip;

the sealing wall comprises a plurality of folds which are circumscribed with the sealing lip and extend outwards transversely, each fold comprises a fold peak, a fold valley and a fold wall extending from the fold peak to the fold valley, and the folds are arranged in a disc shape around the whole sealing lip;

the protective wall of the first protective device comprises the same number of folds matched with the sealing wall in shape and size;

the boundary of the distal opening of the first protection device is formed by a wavy annular line, the wavy annular line is positioned on a cylindrical surface, the perimeter of the wavy annular line is L3, the maximum instrument radius which is designed to be inserted is R3, wherein L3 is more than 2 pi R3, and pi=3.14;

the pleats in the shape of a dish satisfy the following relationship: defining a plane perpendicular to the central axis of the sealing film as a transverse plane, defining an included angle alpha between the fold peaks and the transverse plane, defining an included angle beta between the fold valleys and the transverse plane as 0 degrees or more and 15 degrees or less and 0 degrees or more and beta or less and 15 degrees or less;

The folds of the first protection device are arranged in a disc shape around the axis, and the first protection device is matched with the sealing wall, so that an external insertion instrument is effectively prevented from puncturing or tearing the sealing film;

the proximal end of the first protector comprises a flange, each of said pleats of the first protector comprises a pleat wall extending between a pleat peak and a pleat valley, said pleats of the first protector extend laterally outwardly from the undulating ring line and said pleats intersect the extending wall of said flange, a plurality of cutting slots are included between said pleats and said extending wall, said plurality of cutting slots cleaving said pleats and extending wall to form a plurality of ribs connecting said pleats and extending wall.

2. A pleated puncture sealing system comprising a sealing membrane and the first protection device of claim 1.

3. The sealing system of claim 2, further comprising a second protective device having a protective wall comprising the same number of folds and matching shape and size as the sealing wall; the first protection device is arranged at the proximal end of the sealing film, the second protection device is arranged at the distal end of the sealing film, the protection wall of the first protection device is close to the proximal end face of the sealing wall, and the protection wall of the second protection device is close to the distal end face of the sealing wall.

4. A sealing system as claimed in claim 3, wherein the depth of the pleats of the sealing membrane remains constant or gradually decreases as the pleats extend laterally outwardly.

5. A sealing system according to claim 3, wherein the sealing wall comprises 10 pleats.

6. The sealing system of claim 2, wherein the sealing membrane further comprises a flange and an inner groove, the first protection device comprising a flange that matches the shape and size of the inner groove, the flange of the first protection device being embedded in the inner groove.

7. The sealing system of claim 3, further comprising a first securing ring and a second securing ring, the first securing ring and the second securing ring clamping the first protective device and the sealing membrane.

8. The sealing system of any of claims 2-7, wherein the sealing membrane comprises a flange and an outer float portion extending from the flange to the proximal opening, the outer float portion having at least one transverse fold; the sealing system further includes an upper housing and an upper cover, the proximal opening of the sealing membrane being sandwiched between the upper housing and the upper cover.

9. A puncture outfit comprising the sealing system of claim 8, further comprising a cannula, a duckbill seal and a lower cap; the duckbill seal is secured between the sleeve and the lower cap to form a first seal assembly; the sealing system and the first sealing component are fixed together through a quick locking structure.