CN109394313B

CN109394313B - Hourglass type sealing film and assembly

Info

Publication number: CN109394313B
Application number: CN201811299700.XA
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: 2023-06-23
Anticipated expiration: 2036-08-02
Also published as: CN109394313A; CN106137341A; CN106137341B

Abstract

The invention relates to an hourglass type sealing film and an hourglass type sealing assembly. The sealing membrane comprising a proximal opening and a distal aperture, a sealing wall extending from the distal aperture to the proximal opening, the sealing wall having a proximal face and a distal face; the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a hermetic seal; the sealing wall is a seamless sealing body formed by a plurality of forward grooves and a plurality of reverse grooves around the sealing lip in a positive-negative alternating manner, the forward grooves are recessed from the proximal end face to the distal end face of the sealing wall and open towards the proximal end face, and the reverse grooves are recessed from the distal end face to the proximal end face of the sealing wall and open towards the distal end face; the sealing wall is in an hourglass shape as a whole; the sealing membrane further includes an annular wall intersecting the forward groove and the reverse groove. Thereby the friction resistance and the stick-slip can be greatly reduced, and simultaneously the probability of occurrence of the inversion of the sealing film is also reduced or the operation comfort after the inversion of the sealing film is improved.

Description

Hourglass type sealing film and assembly

The application is named as: an hourglass type sealing film containing grooves, an hourglass type sealing film component and application dates are as follows: the application number of the product is 2016, 08 and 02: division of the invention patent application of 201610630857.0.

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 wall735 the strain (stress) is greater in the region from the seal lip 734 to the intersection 738, which is referred to as the seal lip adjacent region (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 defects caused by the large friction resistance, the inversion of the sealing film is the most influencing on the service performance of the sleeve assemblyOne of the serious problems. 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 an easily deformable groove, characterized in that, starting from a sealing lip, there are a plurality of easily deformable grooves on the conical surface of the sealing film; 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 puncture outfit sealing membrane having a proximal opening and a distal aperture and a sealing wall extending from the distal aperture to the proximal opening. The distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a seal. The sealing wall has a proximal face and a distal face. The sealing film can reduce friction resistance and improve stick-slip when large-diameter instruments are applied on the premise of ensuring reliable sealing for inserted 5mm instruments.

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. 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, a sealing membrane for a puncture outfit for minimally invasive surgery includes a proximal opening and a distal aperture and a sealing wall extending from the distal aperture to the proximal opening, the sealing wall having a proximal face and a distal face. The distal aperture is formed by a sealing lip that is cylindrical for receiving an inserted instrument and forming a hermetic seal. The seal wall is a seamless seal body formed by a plurality of forward grooves recessed from a seal wall proximal end face toward a distal end face and opening toward the proximal end face and a plurality of reverse grooves recessed from the seal wall distal end face toward the proximal end face and opening toward the distal end face in a positively and negatively alternating manner around the seal lip. The sealing wall is in an hourglass shape as a whole. The number of the forward grooves and the number of the reverse grooves are 6, and the cross section of each groove is approximately U-shaped. The sealing membrane further includes an annular wall intersecting the forward groove and the reverse groove. The annular wall includes a proximal end and a distal end, the proximal end of the annular wall including an upper flange and the distal end of the annular wall including a lower flange. Optionally, the sealing membrane further comprises an outer floating portion extending from the flange to the proximal opening comprising at least one transverse fold. In an alternative embodiment, the wall thickness of the forward and reverse grooves is substantially uniform. In yet another alternative, the forward recess has an internal width B in the vicinity of the sealing lip, wherein 0.5 mm.ltoreq.B.ltoreq.1 mm.

In another aspect of the invention, a sealing membrane for a puncture outfit for minimally invasive surgery includes a proximal opening and a distal aperture and a sealing wall extending from the distal aperture to the proximal opening, the sealing wall having a proximal face and a distal face. The distal aperture is formed by a sealing lip that is cylindrical for receiving an inserted instrument and forming a hermetic seal. The seal wall is a seamless seal body formed by a plurality of forward grooves recessed from a seal wall proximal end face toward a distal end face and opening toward the proximal end face and a plurality of reverse grooves recessed from the seal wall distal end face toward the proximal end face and opening toward the distal end face in a positively and negatively alternating manner around the seal lip. The sealing wall is in an hourglass shape as a whole. The number of the forward grooves and the number of the reverse grooves are 6, and the cross section of each groove is approximately V-shaped. The sealing membrane further includes an annular wall intersecting the forward groove and the reverse groove. The annular wall includes a proximal end and a distal end, the proximal end of the annular wall including an upper flange and the distal end of the annular wall including a lower flange. The upper flange comprises a complete cylindrical wall and the lower flange comprises a plurality of flanges separated from each other.

In yet another aspect of the present invention, a sealing membrane for a puncture outfit for minimally invasive surgery, the sealing membrane comprising a proximal opening and a distal aperture and a sealing wall extending from the distal aperture to the proximal opening, the sealing wall having a proximal face and a distal face. The distal aperture is formed by a sealing lip that is cylindrical for receiving an inserted instrument and forming a hermetic seal. The seal wall is a seamless seal body formed by a plurality of forward grooves recessed from a seal wall proximal end face toward a distal end face and opening toward the proximal end face and a plurality of reverse grooves recessed from the seal wall distal end face toward the proximal end face and opening toward the distal end face in a positively and negatively alternating manner around the seal lip. The sealing wall is in an hourglass shape as a whole. The number of the forward grooves and the number of the reverse grooves are 6, and the cross section of each groove is approximately U-shaped. The sealing membrane further includes an annular wall intersecting the forward groove and the reverse groove. In an alternative embodiment, the sealing wall comprises a thickened region in the vicinity of the sealing lip, the wall thickness of the thickened region being greater than the wall thickness of the sealing wall outside the vicinity of the sealing lip. The sealing membrane comprises a plurality of radially divergent ribs, one end of which connects to the thickened region and the other end of which intersects the annular wall extension.

It is another object of the present invention to provide a puncture outfit sealing membrane assembly comprising the aforementioned sealing membrane, a first securing ring, a second securing ring, a third securing and protecting means. The second fixing ring is arranged between the upper flange and the lower flange of the sealing film, and the protecting device is arranged on one side of the proximal end face of the sealing film; the sealing membrane and the protection device are sandwiched between a first fixing ring and a third fixing ring, which fix the sealing membrane, the second fixing ring and the protection device together.

An instrument seal assembly comprising the sealing membrane assembly, and further comprising an upper shell and an upper cover; the sealing membrane comprising an outer float portion extending from the upper flange to the proximal opening, the outer float portion comprising at least one transverse fold; the proximal end of the sealing membrane is sandwiched between the upper housing and the upper cover, and the external floating portion allows the sealing membrane assembly to move or float within a sealed compartment formed by the upper housing and the upper cover.

A puncture outfit comprises the device sealing assembly, 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 instrument seal assembly and the first seal assembly are secured together by a quick lock arrangement.

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 an exploded view of the sealing membrane assembly of the sleeve assembly of FIG. 5;

FIG. 7 is a perspective partial cross-sectional view 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 plan view projection of the sealing membrane assembly of FIG. 7;

FIG. 15 is a cross-sectional view of the sealing membrane assembly of FIG. 14 in simulated deformation 15-15 upon insertion of a 12.8 instrument;

FIG. 16 is a cross-sectional view of the sealing membrane assembly of FIG. 14 in a simulated deformation 15-15 during removal of the 12.8 instrument;

FIG. 17 is a perspective view of a sealing film according to another embodiment of the present invention;

FIG. 18 is a reverse perspective view of the sealing membrane of FIG. 17;

FIG. 19 is a cross-sectional view of the sealing film 19-19 of FIG. 17;

FIG. 20 is a 20-20 cross-sectional view of the sealing film of FIG. 17;

FIG. 21 is a perspective view of a sealing film of yet another embodiment of the present invention;

FIG. 22 is a reverse perspective view of the sealing membrane of FIG. 21;

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

FIG. 24 is a cross-sectional view 24-24 of the seal membrane over-stiffener of FIG. 21;

FIG. 25 is a cross-sectional view 25-25 of the sealing film of FIG. 21, but with the ribs;

FIG. 26 is a cross-sectional view 26-26 of the sealing membrane of FIG. 25;

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.

Fig. 2 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 engagement of the hooks 112 with the slots 39 is one-handed quick release. 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. 2 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. 2 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 third securing ring 120, a second securing ring 1200, a sealing membrane 130, a protective device 160, and a first securing ring 170. 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 also includes an upper flange 136 and a lower flange. The sealing wall 135 is connected at one end to the sealing lip 134 and at the other end to the upper flange 136 and the lower flange 139, respectively, and the upper flange 138 and the lower flange 139 are connected by an annular wall 138. The floating portion 137 is connected to the upper flange 136 at one end and to the proximal end 132 at the other end. The float portion 137 includes one or more radial (transverse) pleats to enable the entire sealing membrane assembly 180 to float within the assembly 200. The sealing membrane 130 and the protective device 160 are sandwiched between the third rigid ring 120 and the first rigid ring 170. Referring to fig. 7, the second fixing ring 1200 is sandwiched between the upper flange 136 and the lower flange 139 of the sealing film 130, and the sealing film 130 and the protection device 160 are sandwiched between the first fixing ring and the third fixing ring. And the posts 121 of the third securing ring 120 are aligned with corresponding holes in the other components of the assembly 180. The post 121 is an interference fit with the bore 171 of the first rigid retainer ring 170, thereby placing the entire sealing membrane assembly 180 in compression. The protector 160 includes 4 sequentially overlapping protective tabs 163 for protecting the central seal of the sealing membrane 130 from perforation or tearing by the sharp edges of the inserted surgical instrument.

The assembly 180 may be made of many materials having different characteristics. For example, the sealing film 130 is made of a superelastic material such as silica gel, isoprene rubber, etc.; the protective device 160 is a semi-rigid thermoplastic elastomer; while the lower and upper retaining rings 120 and 170 are formed of a relatively hard plastic material such as polycarbonate.

Fig. 8-11 depict a first embodiment of a sealing film 130 of the present invention in greater detail. To reduce production costs, the sealing membrane 130 is preferably designed as one piece, but may also be designed as two parts, an inner sealing body and an outer floating part, separated from the flange 136. An embodiment one is directed to improvements in the inner seal. For simplicity of presentation, the sealing film is not shown in the following description of the outer floating portion and proximal end.

The axis of the lip 134 is defined as 158 and a transverse plane 159 is defined substantially perpendicular to the axis 158 at any point along the lip 134. The sealing wall 135 includes an inner sidewall 141, an outer sidewall 142 and a sidewall 143. The inner sidewall 141 extends laterally from the sealing lip 134 to the annular wall 138; the outer side wall 142 extends laterally from the sealing lip 134 to the annular wall 138; while one end of the annular wall 138 extends and intersects the upper flange 136 and the other end thereof extends and intersects the lower flange 139. The first edge of the sidewall 143 intersects the inner sidewall 141 to form intersecting

lines

145a,145b; a second edge of the sidewall 143 intersects the outer sidewall 142 to form

intersection lines

146a,146b; the third side of the sidewall 143 intersects the annular wall 138 to form

intersections

147a,147b.

The intersection line 145a (145 b) is defined to have an angle alpha with the transverse plane 159, the intersection line 146a (146 b) is defined to have an angle beta with the transverse plane 159, and-90 DEG < beta < 0,0 < alpha < 90 deg. The inner and

outer side walls

141, 142 are generally symmetrical about the transverse plane 159, with all of the inner and

outer side walls

141, 142 being generally arranged in an approximately hourglass shape (alternatively referred to as a double funnel shape) about the axis 158; the plurality of inner side walls 141 are arranged in a funnel shape or a truncated cone shape around the axis 158 as viewed from a proximal end face, and the plurality of outer side walls 142 are arranged in a funnel shape or a truncated cone shape around the axis 158 as viewed from a distal end face. The

intersection lines

145a and 146a (or 145b and 146 b) are defined to intersect at an angle θ. The intersection of the two intersecting lines (i.e., the vertex of angle θ) may be present on the sealing lip 134; or virtual extensions of the two intersecting lines intersect inside the sealing lip 134. The side wall 143 is thus a two-sided defined area extending radially outward from the sealing lip 134 and widening.

8-11, the 2 adjacent side walls 143 and the outer side wall 142 therebetween form a recess from the proximally-facing distally-recessed opening toward the proximal face and increasing in axial depth, defined as a forward recess 140; while the 2 adjacent side walls 143 and the inner side wall 141 therebetween form a recess, which is formed from the opening of the distal-facing proximal-facing recess toward the distal face and gradually increases in depth along the axial direction, defined as a reverse recess 150. The inner sidewall 141, the sidewall 143 and the outer sidewall 142 form a series of forward and reverse grooves that alternate around the sealing lip 134, extending laterally outward and gradually increasing in axial depth. I.e. a series of alternating grooves of progressively increasing axial depth, form a seamless hourglass-shaped sealing wall 135. The annular wall 138 intersects both the forward groove 140 and the reverse groove 150, and the annular wall 138 intersects the upper flange 136 at one end and the lower flange 139 at the other end. The annular wall 138 is a complete revolution wall, in this example the annular wall 138 is approximately cylindrical in shape, however it may be an approximately conical or irregular revolution wall.

In an alternative embodiment, as shown in fig. 12-13, the wall thickness of the forward and reverse grooves is substantially uniform, i.e., the wall thickness of the inner sidewall 141, the outer sidewall 142, and the sidewall 143 are substantially equal. The substantially uniform wall thickness is such that deformation of the sealing wall 135 is substantially uniform. The substantially uniform wall thickness should not be limited to absolute equality of values. When the number of grooves is large, the thickness of the sidewall 143 may be 0.05 to 0.25mm thinner than the thickness of the inner sidewall 141 (or the outer sidewall 142) for convenience of manufacturing (e.g., for enhancing the strength of the mold at the grooves), or for consideration of error. While the wall thickness values of the inner and

outer side walls

141, 142, 143 are relatively small, for ease of quantification, the wall thickness ratio of the inner side wall 141 (or outer side wall 142) to the side wall 143 is defined to be between 1 and 1.5, still approximately considering the wall thickness of the sealing wall 135 as substantially uniform, without departing from the scope of the present invention.

The sealing wall 135 of the present example contains 6 linear forward grooves and 6 linear reverse grooves, however, a greater or lesser number or non-linear grooves may be employed. The side walls 143 of this example are substantially parallel to the axis 158, and any cross section parallel to the axis 158 and perpendicular to any one of the side walls 143 is made in the vicinity of the seal lip, and the cross section intersecting the groove 140 being cut is approximately U-shaped (the cross section of the other grooves is defined in this way). However, for ease of manufacture, such as ease of demolding, the side walls 143 may be non-parallel to the axis 158; i.e. the cross-section of the forward groove 140 or the reverse groove 150 is approximately trapezoidal, even approximately V-shaped.

With axis 158 as the axis of rotation, a radius R is made ₁ Is a cylindrical cutting surface M of (2) ₁ (not shown), the cutting surface M ₁ The sealing membrane 130 is divided into an inner portion 156 (fig. 12) and an outer portion 157 (fig. 13). The cutting surface M ₁ Intersecting the inner sidewall 141 to form a plurality of intersecting

lines

151a and 151b. The cutting surface M ₁ Intersecting the sidewall 143 to form

multi-segment intersecting lines

153a and 153b. The cutting surface M ₁ Intersecting the outer sidewall 142 form

multi-segment intersection lines

152a and 152b. The

multi-segment lines

151a,152a,153a form a circular intersection line 155a; the

multi-segment lines

151b,152b,153b form a circular intersection line 155b. The

annular intersections

155a and 155b define a cross section 155.

As is evident from fig. 12-13, the perimeter L of the intersection line 155a (155 b) ₁ Far greater than 2 pi R ₁ I.e. the grooves act to increase the circumferential perimeter. And L is ₁ And 2 pi R ₁ The difference is approximately equal to the length L of the intersection line 153a (153 b) ₂ The side wall 143 actually serves to increase the circumferential perimeter by a factor 2*P (P is the number of forward grooves). That is, increasing the groove width does not increase the circumferential perimeter to a greater extent, provided that the groove width meets the manufacturable conditions

Those skilled in the art will appreciate that there must be some R ₁ Value of the cutting plane M ₁ A divided outer portion 157 opens from the cross section 155Initially, the change in shape is mainly manifested by local bending deformation and macroscopic displacement of the sealing film, rather than overall microscopic molecular chain elongation and overall tensile deformation. While the shape of the inner portion 156, from the seal lip 134 to the cross section 155, changes in shape to exhibit the combined effect of localized bending deformation and overall stretching deformation of the seal film. It can be seen that the grooves increase the circumferential circumference, reducing the circumferential strain (stress) when large diameter instruments are applied, thereby reducing the hoop force and the frictional resistance.

Fig. 14-16 depict simulated deformation of the sealing membrane assembly 180 (the external floating portion 137 and the protective device 160 are not shown) as the large diameter instrument is inserted and withdrawn. The inner sidewall 141 is divided into an inner sidewall 141c and a cylindrical wall 141d when the large diameter instrument is inserted; and the outer side wall 142 is divided into an outer side wall 142c and a cylindrical wall 142 d; the side wall 143 is divided into a side wall 143c and a cylindrical wall 143d (not shown). Wherein the cylindrical wall 141d, the cylindrical wall 142d, and the cylindrical wall 143d together form a wrapping region around the outer surface of the insertion instrument.

When large diameter instruments are pulled outwardly from the seal membrane assembly 180, the seal membrane may under certain conditions invert. Referring to fig. 16, in this example, the sealing membrane 130 comprises alternating grooves, the sealing walls of which form a substantially symmetrical hourglass shape with respect to the transverse plane 159; and during the extraction of the instrument, the upper flange 136, the annular wall 138, the lower flange 139 of the sealing membrane 130 will undergo little displacement and deformation under the constraint of the second fixing ring 1200; therefore, the deformation of the sealing film is similar to the process of inserting the device in the process of pulling out the device after the sealing film is turned inwards. When the function of the protector 160 to reduce the frictional resistance is ignored, for example, when the protector 160 is not attached, it is approximately considered that the frictional resistance is substantially equal when the instrument is inserted and when the instrument is pulled out after the sealing film is turned in. The sealing film with the hourglass-shaped front-back alternate grooves can reduce the difference of friction resistance when the instrument is inserted into and pulled out of the sealing film, and improves application comfort.

In this example, the side walls 143 together enhance the axial tensile stiffness of the seal lip in the immediate vicinity; and the side wall 143 does not increase the circumferential rigidity while increasing the axial tensile rigidity, so that the circumferential rigidity is increased while not increasing the hoop force, and the stick-slip can be effectively reduced. In this example 12 of said side walls 143 are included, however more or fewer side walls may also serve to increase the axial tensile stiffness.

The

grooves

140 and 150 may be used to store grease. When large diameter instruments are inserted, the wrapping area formed by deformation of the grooves is smaller, and only the smaller sections of the grooves are flattened. The non-flattened grooves close to the wrapping area have a good function of storing lubricating grease. As the instrument moves in the sealing film, grease in the wrapped area is first scraped away, and grease in the non-flattened grooves adjacent to the wrapped area will replenish the instrument surface and thus the wrapped area as the instrument moves. In an alternative, the groove in the vicinity of the sealing lip has an internal width B ₁ Wherein 0.5mm is less than or equal to B ₁ Is less than or equal to 1mm. When the inner width of the groove in the vicinity of the seal lip is less than 0.5mm, the groove structure is difficult to manufacture; the larger the internal width of the groove is, the poorer the fat storage effect is; researches show that when the internal width of the groove is less than or equal to 1mm, the fat storage effect is good. The grease storage effect of the grooves improves the problem of unreliable lubrication as described in the background. Helping to reduce stick-slip as described in the background.

In summary, the groove structure has the functions of increasing circumferential perimeter, reducing wrapping area, reducing real contact area between the device and the sealing film, improving lubrication reliability, increasing axial tensile rigidity and the like, so that friction resistance and stick-slip can be greatly reduced, and meanwhile, probability of occurrence of inversion of the sealing film is reduced or operation comfort after inversion of the sealing film is improved.

Fig. 17-20 depict in detail a second embodiment sealing film 230 of the present invention. The sealing membrane 230 includes a distal opening 233, a sealing lip 234, a sealing wall 235, an annular wall 238, and upper and

lower flanges

236 and 239. The distal aperture 233 is formed by a sealing lip 234. The sealing lip 234 is approximately annular. The sealing wall 235 is connected at one end to the sealing lip 234 and at the other end to the upper flange 236 and the lower flange 239, respectively, and the upper flange 238 and the lower flange 239 are connected by an annular wall 238. The sealing membrane 230 has a proximal face and a distal face. The axis defining the seal lip 234 is 258. Any point on the overseal lip 234 is a transverse plane 259 that is generally perpendicular to the axis 258.

The sealing wall 235 includes a plurality of V-shaped grooves 240 spaced in opposite directions, each groove 240 including two side walls 242. Two adjacent side walls 242 intersect to form a corrugation peak 245a (245 b), while two adjacent side walls 242 intersect to form a corrugation valley 246a (246 b). The pleat peaks 245a (245 b) are defined as having an included angle k with respect to the transverse plane 239, and the pleat valleys 246a (246 b) are defined as having an included angle λ with respect to the transverse plane 239, where k is approximately equal to λ but the two included angles are opposite in direction with respect to the transverse plane 239. 19-20, the forward and reverse intersecting groove 240 is generally hourglass shaped about the sealing lip 234.

The upper flange 236 is a complete cylindrical ring and the lower flange 239 is a non-complete cylindrical ring. The lower flange 239 in this example consists of 4 bosses approximately equispaced around the annular wall 238. The design of the lower flange 239 with a non-complete cylindrical ring can simplify the mold and improve the manufacturing efficiency.

Fig. 21-26 depict in detail a third embodiment sealing film 330 of the present invention. The sealing membrane 330 includes a distal opening 333, a sealing lip 334, a sealing wall 335, an annular wall 338, and upper and

lower flanges

336, 339. The distal aperture 333 is formed by a sealing lip 334. The sealing wall 335 is connected at one end to the sealing lip 334 and at the other end to the upper flange 336 and the lower flange 339, respectively, and the upper flange 338 and the lower flange 339 are connected by an annular wall 338. The sealing membrane 330 has a proximal face and a distal face. An axis 358 defines the sealing lip 334. Any point on the overseal lip 334 is a transverse plane 359 that is generally perpendicular to the axis 358.

The sealing wall 335 includes an inner side wall 341, an outer side wall 342 and a side wall 343. The inner side wall 341 extends laterally from the sealing lip 334 to the annular wall 338; the outer side wall 342 extends laterally from the sealing lip 334 to the annular wall 338; and the annular wall 338 extends across the upper and

lower flanges

336, 339. The first edge of the sidewall 343 intersects the inner sidewall 341 to form intersecting

lines

345a,345b; a second edge of the sidewall 343 intersects the outer sidewall 342 to form

intersection lines

346a,346b; a third side of the side wall 343 intersects the annular wall 338 to form intersections 277 a, 277 b. The inner and

outer side walls

341, 342 are generally symmetrical about the transverse plane 359, with all of the inner and

outer side walls

341, 342 being generally arranged in an approximately hourglass shape about the axis 358. The side wall 343 is a two-sided defined area extending radially outward from the sealing lip 334 and gradually widening.

21-24, the 2 adjacent side walls 343 and the outer side wall 342 therebetween form a recess from the proximally-facing distally-recessed opening toward the proximal face and increasing in axial depth, defined as a forward recess 340; while the 2 adjacent side walls 343 and the inner side walls 341 therebetween form a recess from the opening of the distal-facing proximal-facing recess toward the distal face and gradually increasing in axial depth, defined as a reverse recess 350. The inner side wall 341, the side wall 343 and the outer side wall 342 form a series of forward and reverse grooves alternately distributed around the sealing lip 334, extending laterally outwardly and gradually increasing in axial depth. I.e., a series of alternating grooves of progressively increasing axial depth, form a seamless hourglass-shaped sealing wall 335. The annular wall 338 intersects both the forward recess 340 and the reverse recess 350, and the annular wall 338 intersects the upper flange 336 at one end extension and the lower flange 339 at the other end extension. The annular wall 338 is a complete revolution wall.

Referring to fig. 24-26, the sealing membrane 330 is similar in shape and configuration to the sealing membrane 130, with the primary difference being that the sealing membrane 330 includes a thickened lip adjacent region. In more detail, the wall thickness T of the sealing wall 335 in the vicinity of the sealing lip 334 is defined as ₁ And the wall thickness of the sealing wall 335 other than this is T ₂ And T is ₁ ＞T ₂ . It will be appreciated by those skilled in the art that the sealing lip 334 and its immediate area are generally not covered by a protective sheet, and that the thickening of the sealing wall in the localized area within the immediate area of the sealing lip helps to improve the sealThe durability of the sealing film, the thickness of the sealing wall is determined by the size of the exposed protective sheet, and the area covered by the protective sheet or the area which cannot be contacted by the instrument during the process of inserting the instrument is not necessarily thickened. General T ₁ And T ₂ The ratio of (2) to (3) 0.

As described in the background art, stick-slip is one of the important factors affecting the performance of sealing films. The sealing film 330 is designed to be thinner and thicker as a whole, and the adjacent area of the sealing lip is designed to be thicker locally, so that the durability of the sealing film can be improved, and the hoop tightening force of the sealing film can be reduced to a greater extent. However, reducing the wall thickness of the sealing wall tends to reduce the axial tensile stiffness of the sealing film, resulting in more tendency for stick-slip to occur. In an alternative, a plurality of radially

divergent ribs

348 and 349 are provided on the inner and

outer side walls

341 and 342, the

ribs

348 and 349 having one end connected to a thickened region in the vicinity of the sealing membrane and the other end extending and intersecting the annular wall 338. The

ribs

348 and 349 may increase the overall axial tensile stiffness of the inner and

outer side walls

341 and 342, thereby reducing stick-slip. As previously set forth, the sealing wall 335 is primarily characterized by global diastolic deformation rather than hoop tensile deformation upon insertion of a large diameter instrument in the sealing membrane 330, and thus the addition of the plurality of

ribs

348 and 349 does not increase hoop stiffness.

It will be readily appreciated by those skilled in the art that a reasonable rounded transition may avoid stress concentrations or make it easier for certain areas to deform. The seal film may look much different in appearance due to the smaller size of the seal film, particularly in the region near the seal lip, which is so small that the chamfer is different. In order to clearly show the geometric relationships between the individual elements, the examples described in this disclosure are generally the figures after the fillets have been removed.

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. Such as the positive and negative grooves described in this example, are not limited to having to be U-shaped or V-shaped in shape. For example, in the present invention, it is mentioned that the groove extends laterally outward from the sealing lip, and the "laterally outward extending" should not be limited to a straight line, and the trace when extending laterally outward may be a curve such as a spiral line, a fold line, a multi-segment arc line, or the like. For example, the embodiment of the present invention describes the position relationship of each intersecting surface and the intersecting line thereof, and the intersecting line and the shape of the groove may also be made to be different from the embodiment by adding curved surfaces to form multi-surface stitching or adopting a higher-order curved surface mode, but the present invention is still considered to be not departing from the scope of the present invention as long as the present invention is generally consistent with the concept of the present invention. Several modifications have been mentioned, and other modifications are conceivable to the person skilled in the art. The scope of the present invention should therefore be determined with reference to the appended claims, rather than with reference to the structures, materials, or acts illustrated and described in the specification and drawings.

Claims

1. A puncture outfit sealing membrane for minimally invasive surgery, the sealing membrane comprising a proximal opening and a distal aperture and a sealing wall extending from the distal aperture to the proximal opening, the sealing wall having a proximal face and a distal face; the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a hermetic seal; the sealing lip defines an axis, characterized in that:

a) The sealing film further comprises an upper flange and a lower flange, one end of the sealing wall is connected with the sealing lip, and the other end of the sealing wall is connected with the upper flange and the lower flange at the same time;

b) The sealing wall comprises an inner side wall, an outer side wall and a side wall, wherein the inner side wall and the outer side wall are integrally arranged in an hourglass shape around the axis;

c) The outer side wall and the connected side wall form a forward groove which is formed by an opening recessed from the proximal end surface to the distal end surface, faces the proximal end surface and gradually increases along the axial depth; the inner side wall and the adjacent side wall form a reverse groove which is formed by an opening recessed from the distal end face to the proximal end face, faces the distal end face and gradually increases along the axial depth; the sealing wall is in a seamless hourglass shape with the positive grooves and the negative grooves alternately;

d) The sealing membrane further comprises an annular wall intersecting both the forward and reverse grooves; and one end of the annular wall intersects the upper flange extension and the other end intersects the lower flange extension; the sealing film is made of super-elastic materials;

e) The wall thickness of the forward groove and the reverse groove is uniform throughout.

2. The sealing membrane of claim 1, wherein the sealing membrane increases the circumferential perimeter of the immediate area of the sealing lip and increases the axial tensile stiffness, thereby reducing frictional resistance between the insertion device and the sealing membrane, reducing stick-slip, and reducing frictional resistance between the device and the sealing membrane after inversion of the sealing membrane.

3. The sealing film of claim 2, wherein the cross-sectional shape of the forward groove or the reverse groove is U-shaped or V-shaped.

4. The sealing film of claim 1, wherein the sealing wall includes a thickened region in the vicinity of the sealing lip, the thickened region having a wall thickness greater than a wall thickness of the sealing wall outside the vicinity of the sealing lip.

5. The sealing membrane of claim 4, wherein said sealing membrane comprises a plurality of radially divergent ribs connected at one end to said thickened region and at the other end to intersect said annular wall extension.

6. The sealing membrane of any one of claims 1-5, wherein the upper flange is a complete cylindrical ring and the lower flange is a non-complete cylindrical ring.

7. A sealing membrane assembly comprising the sealing membrane of claim 6, further comprising a first securing ring, a second securing ring, a third securing ring, and a protective device; the second fixing ring is arranged between the upper flange and the lower flange of the sealing film, and the protecting device is arranged on one side of the proximal end face of the sealing film; the sealing membrane and the protection device are sandwiched between a first fixing ring and a third fixing ring, which fix the sealing membrane, the second fixing ring and the protection device together.

8. An instrument seal assembly comprising the seal membrane assembly of claim 7, further comprising an upper housing and an upper cover; the sealing membrane comprising an outer float portion extending from the upper flange to the proximal opening, the outer float portion comprising at least one transverse fold; the proximal end of the sealing membrane is sandwiched between the upper housing and the upper cover.

9. A puncture instrument comprising the instrument seal assembly 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 instrument seal assembly and the first seal assembly are secured together by a quick lock arrangement.