WO2018024104A1 - 一种含多维褶皱的穿刺器密封膜 - Google Patents

一种含多维褶皱的穿刺器密封膜 Download PDF

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Publication number
WO2018024104A1
WO2018024104A1 PCT/CN2017/093603 CN2017093603W WO2018024104A1 WO 2018024104 A1 WO2018024104 A1 WO 2018024104A1 CN 2017093603 W CN2017093603 W CN 2017093603W WO 2018024104 A1 WO2018024104 A1 WO 2018024104A1
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WO
WIPO (PCT)
Prior art keywords
sealing
pleats
sealing film
wall
sealing lip
Prior art date
Application number
PCT/CN2017/093603
Other languages
English (en)
French (fr)
Inventor
朱莫恕
Original Assignee
成都五义医疗科技有限公司
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Filing date
Publication date
Application filed by 成都五义医疗科技有限公司 filed Critical 成都五义医疗科技有限公司
Publication of WO2018024104A1 publication Critical patent/WO2018024104A1/zh
Priority to US16/249,893 priority Critical patent/US10912584B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A61B2017/3464—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/347—Locking means, e.g. for locking instrument in cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening

Definitions

  • the present invention relates to a minimally invasive surgical instrument, and more particularly to a puncturing device sealing structure.
  • a trocar is a surgical instrument used to create an artificial passage into a body cavity during minimally invasive surgery (especially for hard laparoscopic surgery). It usually consists of a cannula assembly and a puncture needle.
  • the general clinical use is as follows: firstly, a small opening is cut in the skin of the patient, and then the puncture needle is inserted through the cannula assembly, but penetrates the abdominal wall through the skin opening to enter the body cavity. Once the body cavity is inserted, the needle is removed, leaving the cannula assembly as a passage for the instrument to enter and exit the body cavity.
  • the cannula assembly typically consists of a cannula, a housing, a sealing membrane (also known as an instrument seal), and a zero seal (also known as an automatic seal).
  • the cannula penetrates from outside the body cavity into the body cavity as a passage for the instrument to enter and exit the body cavity.
  • the outer casing joins the casing, zero seal and sealing membrane into a sealed system.
  • the zero seal typically does not provide a seal for the insertion instrument and automatically closes and forms a seal when the instrument is removed.
  • the sealing film tightens the instrument and forms a seal when the instrument is inserted.
  • four puncture channels are typically established in the abdominal wall of the patient, namely two small inner diameter cannula assemblies (typically 5 mm) and two large inner diameter cannula assemblies (typically 10 to 12 mm).
  • the instrument that typically enters the patient via the small-diameter cannula assembly performs only ancillary procedures; one of the large-diameter cannula assemblies acts as an endoscope channel; and the other large-diameter cannula assembly serves as the primary access for the surgeon to perform the procedure.
  • this main channel about 5% of the time applies 5mm instruments; about 20% of the time applies other large diameter instruments; and 5mm instruments and large diameter instruments need to be switched frequently during surgery.
  • FIGS 1 and 2 depict a typical 12 mm gauge bushing assembly 700.
  • the cannula assembly 700 includes a lower case 710, an upper case 720, and a sealing film 730 sandwiched between the upper case 720 and the lower case 710, a duckbill seal 750.
  • the lower housing 710 includes a central through hole 713 defined by the elongated tube 711.
  • the upper housing 720 includes a proximal aperture 723 defined by an inner wall 721.
  • the sealing membrane 730 includes a proximal opening 732, a distal aperture 733, a sealing lip 734, a frustoconical sealing wall 735, a flange 736 and an outer floating portion 737.
  • the distal opening 733 is formed by a sealing lip 734.
  • the axis defining the sealing lip is 741 defining a transverse plane 742 that is generally perpendicular to the axis 741; the angle between the rotating busbar defining the frustoconical sealing wall 735 and the transverse plane 742 is the guiding angle ANG1.
  • a cylinder having a diameter D i (D i > 5 mm) intersects the sealing wall 735 to form an intersection 738 having a diameter D i .
  • D i diameter of the sealing wall 735
  • the strain (stress) of the sealing wall 735 from the sealing lip 734 to the intersection 738 is large, and the region is referred to as the vicinity of the sealing lip ( Or a region of stress concentration; and the sealing wall 735 has a small strain (stress) from the intersection 738 to the region of the flange 736.
  • the diameter D i of the insertion instrument is different, and the boundary range of the adjacent region (stress concentration region) of the sealing lip is different. To facilitate quantification, it is defined that when D i is the largest diameter of the surgical instrument designed to pass through the sealing membrane, the region from the sealing lip 734 to the intersection line 738 is the adjacent region of the sealing lip.
  • the sealing lip 734 when a large diameter instrument (e.g., 12.8 mm) is inserted, the sealing lip 734 will be inflated to a suitable size to accommodate the inserted instrument; the sealing wall 735 is divided into two portions, a conical wall 735c and a cylindrical wall 735d; The cylindrical wall 735d is wrapped around the outer surface of the instrument to form a wrapped area of highly concentrated stress. Define conical wall 735c and the cylindrical wall 738a to 735d intersecting line; when the instrument is removed, restoring the natural state under the sealing wall 735, defining the intersection line 738a having a radius D x resilient ring 738b ( The line 738b is a curved boundary line when a large diameter instrument is inserted.
  • a large diameter instrument e.g., 12.8 mm
  • the angle between the slewing busbar defining the conical wall 735c and the transverse plane 742 is ANG2, and ANG2>ANG1; that is, the sealing wall 735 is fulcrum with the intersection of the flange 736 and the sealing wall 735 when the large diameter instrument is inserted.
  • Rotational relaxation Defining the height of the cylindrical wall 735d is H a.
  • the H a is not a fixed value, the distal hole size is different, the sealing lip is different in size, the sealing wall wall thickness is different, and the guiding angle is different or the insertion instrument diameter is different, and the like, the H a is different.
  • the inverted wall 735 is divided into a cylindrical wall 735e, a conical wall 735f, and a conical wall 735g; the cylindrical wall 735e is wrapped around the outer surface of the instrument to form a wrapped area where the stress is highly concentrated. Defining the height of the cylindrical wall 735e is H b, H b is typically greater than H a; i.e.
  • the simplest way to reduce the frictional resistance is to use a grease to reduce the coefficient of friction between the two contact faces.
  • the reliability of this measure is not good. In clinical applications, the grease is easily detached from the surface of the sealing film and carried away due to repeated long-term scratching of the sealing film and repeated switching of various instruments, resulting in poor lubrication.
  • a protective sheet that is in close contact with a sealing film is disclosed in U.S. Patent No. 5,342,315.
  • the protective sheet can prevent the sharp edge of the instrument from damaging the sealing film, and because the friction coefficient of the surface of the protective sheet is smaller than the friction coefficient of the surface of the sealing film, the frictional resistance can be reduced to some extent.
  • the adjacent area of the sealing lip is generally not completely covered by the protective sheet.
  • a ribbed sealing film is disclosed in US Pat. Small frictional resistance.
  • An approximate rib has the effect of reducing the contact area and increasing the axial tensile strength of the sealing film as disclosed in European Patent No. EP0994740.
  • U.S. Patent No. 7,784,2014 discloses a pleated sealing film which is characterized by a wavy sealing lip and a wavy pleated sealing body.
  • the pleated structure can increase the circumferential circumference and reduce the tightening force to some extent.
  • the Chinese invention application CN101480354A discloses a sealing film containing a deformable groove, starting from the sealing lip, having a plurality of easily deformable grooves on the conical surface of the sealing film; the wall thickness of the deformable groove Far smaller than the wall thickness of the conical surface; mainly by the elongate deformation of the variability groove to accommodate the inserted large diameter instrument.
  • the disclosed technical solution basically proposes a solution only from a certain factor affecting the frictional resistance, and the effect of reducing the frictional resistance is small or not obvious. .
  • other defects are introduced even by improving one factor.
  • adding a rib on the sealing film can reduce the contact area, but at the same time increase the tightening force; for example, using a deformable groove having a thickness much smaller than the truncated cone surface, the easily deformable groove is easily damaged; for example, if a wave seal is used
  • the lip increases the circumferential circumference at the opening of the sealing film, thereby sacrificing the sealing reliability when applying a 5 mm instrument.
  • the sealing film is usually made of a rubber material such as natural rubber, silicone rubber or isoprene rubber, and the rubber material has superelasticity and viscoelasticity.
  • a rubber material such as natural rubber, silicone rubber or isoprene rubber
  • the rubber material has superelasticity and viscoelasticity.
  • the mechanical model of the rubber deformation process is very complicated, it can be approximated by the generalized Hooke's law to describe its elastic behavior; the Newtonian internal friction law is used to describe its viscous behavior.
  • the main factors affecting the friction between the rubber and the device include: the smaller the friction coefficient of the two contact faces, the smaller the friction; the better the lubrication condition between the two contact faces, the smaller the friction; the difference between the two contact faces The smaller the true contact area, the smaller the frictional force; the smaller the normal pressure between the two contact faces, the smaller the frictional force.
  • the present invention comprehensively considers the above factors and proposes a more perfect solution for reducing the frictional resistance between the sealing film and the insertion instrument.
  • the sealing film stick slip is another important factor affecting the performance of the piercer.
  • the stick-slip that is, when the instrument moves axially in the sleeve, the sealing lip of the sealing film and its adjacent area are relatively statically adhered to the instrument (the friction between the instrument and the sealing film is mainly static friction). Force); and sometimes the phenomenon of relative sliding with the instrument (when the friction between the instrument and the sealing film is mainly dynamic friction); and the static friction is much greater than the dynamic friction.
  • the static friction and dynamic friction alternately occur, which causes the resistance of the movement of the instrument in the sealing film to be unstable and the moving speed to be unstable.
  • the physician can only use the instrument to access the patient's internal organs and monitor the local extent of the instrument's working head with the aid of an endoscopic imaging system.
  • the surgeon usually uses the resistance feedback when moving the instrument as one of the information to determine whether the surgical operation is normal.
  • the stickiness of the sealing film affects the comfort of operation, positioning accuracy, and even induces doctors to make false judgments.
  • the stick-slip is difficult to avoid completely during use of the cannula assembly, but can be reduced.
  • increasing the axial tensile stiffness of the sealing film also helps to reduce the stick-slip phenomenon.
  • the invention also proposes measures for improving stick slip.
  • a trocar sealing membrane comprising a proximal opening and a distal opening and a sealing wall extending distally from the proximal end.
  • the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a seal.
  • the sealing lip includes a central axis and a transverse plane that is substantially perpendicular to the axis.
  • the sealing wall has a proximal end surface and a distal end surface.
  • the sealing film can reduce frictional resistance and improve stick-slip when applying large-diameter instruments while ensuring a reliable seal for the inserted 5 mm instrument.
  • the sealing wall further comprises a solid rib extending laterally outward from the sealing lip.
  • the sealing wall further comprises a laterally outwardly extending recess extending from the distal end of the sealing wall toward the proximal end surface toward the distal end surface, from the perspective of the proximal end surface.
  • the reverse groove is convex from the proximal end face a rib, and the reverse groove comprises two planar, non-pleated sidewalls.
  • the cross section of the tangential pleats is U-shaped.
  • the cross section of the tangential pleats is V-shaped.
  • the sealing lip is annular or cylindrical.
  • a flange is also included that simultaneously intersects the pleats and the ribs, and a floating portion that includes a plurality of lateral pleats extending from the flange to the proximal opening.
  • Another object of the present invention is to provide a puncturing device sealing assembly comprising the sealing film, the sealing assembly further comprising a lower fixing ring, an upper fixing ring, a protection device, an upper casing and an upper cover; the sealing film Also included is a flange that simultaneously intersects the pleats and the ribs, and an outer floating portion including at least one lateral pleat extending from the flange to the proximal opening; the sealing film and the protective device are clamped to the upper retaining ring and Between the lower retaining rings, the proximal opening of the sealing membrane is sandwiched between the upper casing and the upper cover.
  • the cylindrical wrapping area formed by the sealing lip and its adjacent area when inserted into a large diameter instrument is the source of greater frictional resistance.
  • it is necessary to comprehensively consider reducing the radial stress between the instrument and the sealing film, reducing the cylindrical wrapping area between the instrument and the sealing film, and reducing the true contact area between the instrument and the sealing film.
  • increasing the circumferential circumference can reduce the circumferential strain (stress), thereby reducing the radial strain (stress).
  • the strain (stress) of the sealing lip cannot be reduced by increasing the circumferential circumference, which results in a decrease in sealing reliability when a 5 mm instrument is applied. Since the stress in the vicinity of the sealing lip is highly concentrated when applying a large-diameter instrument, the circumferential circumference of the vicinity of the sealing lip should be rapidly increased; for the region outside the vicinity of the sealing lip, the strain (stress) is small. It is not necessary to adopt measures to increase the circumferential circumference. In addition, increasing the circumferential circumference of the ring should also increase the axial tensile stiffness of the vicinity of the sealing lip in order to improve the stick-slip phenomenon in the vicinity of the sealing lip.
  • the sealing membrane includes a proximal opening and a distal opening and a sealing wall extending from the distal opening to the proximal opening, the sealing wall having a proximal end surface and a distal end surface.
  • the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a hermetic seal.
  • the sealing wall simultaneously has a plurality of transverse pleats extending laterally outward from the sealing lip and tangential pleats uniformly distributed around the sealing lip.
  • the pleated sealing wall increases the circumferential circumference of the adjacent region of the sealing lip and helps to reduce overall deformation when large diameter instruments are applied, thereby reducing friction and improving sealing reliability.
  • the sealing membrane in another aspect of the invention, includes a proximal opening and a distal opening and a sealing wall extending from the distal opening to the proximal opening, the sealing wall having a proximal end surface and a distal end surface.
  • the distal hole is formed by a sealing lip for receiving The inserted instrument is formed into a hermetic seal.
  • the sealing wall In the vicinity of the sealing lip, the sealing wall simultaneously has a plurality of transverse pleats extending laterally outward from the sealing lip and tangential pleats uniformly distributed around the sealing lip.
  • the sealing wall also includes a solid rib extending laterally outward from the sealing lip, the solid ribs enhancing the axial tensile stiffness of the adjacent region of the sealing lip to improve stick-slip.
  • the sealing film includes a proximal opening and a distal opening and a sealing wall extending from the distal opening to the proximal opening, the sealing wall having a proximal end surface and a distal end surface.
  • the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a hermetic seal.
  • the sealing wall simultaneously has a plurality of transverse pleats extending laterally outward from the sealing lip and tangential pleats uniformly distributed around the sealing lip.
  • the sealing wall further includes a laterally outwardly extending recess extending from the distal end of the sealing wall toward the proximal end surface toward the distal end surface, the reverse groove being viewed from a near end surface Is a rib that protrudes from the proximal end face; and the reverse groove includes two planar, non-pleated sidewalls.
  • the cross section of the tangential pleats is approximately V-shaped; and the cross-sectional shape of the reverse grooves is approximately U-shaped; the sealing lip is cylindrical.
  • the sealing film also includes a flange that intersects the transverse pleats, the tangential pleats, and the reverse grooves, and an outer floating portion that includes a plurality of lateral pleats extending from the flange to the proximal opening.
  • the pleated sealing wall and the reverse groove together increase the circumferential circumference of the adjacent region of the sealing lip, helping to reduce the frictional resistance.
  • the reverse groove increases the axial tensile stiffness of the vicinity of the sealing lip, thus improving the stick slip.
  • the sealing film includes a proximal opening and a distal opening and a sealing wall extending from the distal opening to the proximal opening, the sealing wall having a proximal end surface and a distal end surface.
  • the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a hermetic seal.
  • the sealing wall simultaneously has a plurality of transverse pleats extending laterally outward from the sealing lip and tangential pleats uniformly distributed around the sealing lip; the sealing wall further comprising a laterally outwardly extending from the sealing lip distally from the sealing wall a reverse groove facing the distal end face toward the distal end face, the reverse groove being a rib protruding from the proximal end face from a near end face; and the reverse groove includes two planes Non-pleated side walls.
  • the shape of the cross section of the tangential pleats is approximately U-shaped; and the cross-sectional shape of the reverse grooves is approximately U-shaped; the sealing lip is annular.
  • the pleated sealing wall and the reverse groove together increase the circumferential circumference of the adjacent region of the sealing lip, helping to reduce the frictional resistance.
  • the reverse groove increases the axial tensile stiffness of the vicinity of the sealing lip, thus improving the stick slip.
  • the sealing assembly comprises a lower fixing ring, a sealing film, a protection device, an upper fixing ring, an upper casing and an upper cover.
  • the sealing membrane and the protective device are sandwiched between lower retaining rings for protecting the sealing membrane from sharp edges of the insertion device.
  • the proximal end of the sealing film is sandwiched between the upper casing and the upper cover, and the outer floating portion of the sealing film can make the sealing film and the protection device laterally in the sealed chamber formed by the upper casing and the upper cover mobile.
  • Figure 1 is a simulated deformation view of a prior art cannula assembly inserted into a 5 mm instrument
  • FIG. 2 is a detailed view of a prior art sealing film 730
  • Figure 3 is a simulated deformation view of a prior art cannula assembly inserted into a 12.8 mm instrument
  • FIG. 4 is a simulated deformation diagram of a prior art cannula assembly with a 12.8 mm instrument removed;
  • Figure 5 is a perspective, partial, cross-sectional view of the cannula assembly of the present invention.
  • Figure 6 is an exploded view of the sealing membrane assembly of the sleeve assembly of Figure 5;
  • Figure 7 is a perspective partial cross-sectional view of the sealing film assembly of Figure 6;
  • Figure 8 is a perspective view of the sealing film of the sealing film of Figure 6 after the proximal end and the floating portion are omitted;
  • Figure 9 is a perspective cross-sectional view of the sealing film of Figure 8 in a reverse direction
  • Figure 10 is a cross-sectional view taken along line 10-10 of the sealing film of Figure 8;
  • Figure 11 is a cross-sectional view taken along line 11-11 of the sealing film of Figure 8.
  • Figure 12 is a perspective view of a sealing film of a second embodiment of the present invention.
  • Figure 13 is a perspective view of the sealing film of Figure 12 in the reverse direction;
  • Figure 14 is a cross-sectional view taken along line 14-14 of the sealing film of Figure 12;
  • Figure 15 is a cross-sectional view taken along line 15-15 of the sealing film of Figure 12;
  • Figure 16 is a perspective view of a sealing film of a third embodiment of the present invention.
  • Figure 17 is a perspective view of the sealing film of Figure 16 in the reverse direction;
  • Figure 18 is a cross-sectional view taken along line 18-18 of the sealing film of Figure 16;
  • Figure 19 is a cross-sectional view taken along line 19-19 of the sealing film of Figure 16;
  • Figure 20 is a perspective view of a sealing film of a fourth embodiment of the present invention.
  • Figure 21 is a perspective view of the sealing film of Figure 20 in the reverse direction;
  • Figure 22 is a cross-sectional view taken along line 22-22 of the sealing film of Figure 20;
  • Figure 23 is a cross-sectional view of the sealing film of Figure 20 taken along line 23-23;
  • Figure 24 is a cross-sectional view taken along line 24-24 of the sealing film shown in Figure 20;
  • Figure 25 is a schematic view of the sealing film of Figure 21 after rounding
  • FIG. 5 depicts the overall structure of the trocar.
  • a typical trocar includes a puncture 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.
  • the puncture needle 10 extends through the cannula assembly 20 and then penetrates the entire abdominal wall through the skin opening into the body cavity. Once in the body cavity, the puncture needle 10 is removed and the cannula assembly 20 is left as a passage for the instrument to enter and exit the body cavity.
  • the proximal end 192 is external to the patient and the distal end 31 is within the patient.
  • a preferred bushing assembly 20 can be divided into a first seal assembly 100 and a second seal assembly 200.
  • the card slot 39 of the assembly 100 and the hook 112 of the assembly 200 are fastened.
  • the cooperation of the hook 112 and the card slot 39 can be quickly split by one hand. This is mainly for the purpose of taking out tissues or foreign bodies in the patient during surgery.
  • the quick lock connection between the assembly 100 and the assembly 200 In addition to the structure shown in this embodiment, a threaded connection, a rotary snap or other quick lock structure may be employed.
  • the assembly 100 and assembly 200 can be designed as structures that are not quick to split.
  • FIG. 5 depicts the composition and assembly relationship of the first seal assembly 100.
  • the lower housing 30 includes an elongated tube 32 that defines a sleeve 33 that extends through the distal end 31 and that is coupled to the outer casing 34.
  • the lower housing 30 has an inner wall 36 that supports a duckbill seal and a valve mounting hole 37 that communicates with the inner wall.
  • the spool 82 is mounted in the valve body 80 and mounted together in the mounting hole 37.
  • the flange 56 of the duckbill seal 50 is sandwiched between the inner wall 36 and the lower cover 60.
  • There are various ways of fixing the lower cover 60 and the lower casing 30, and the interference fit, ultrasonic welding, glue bonding, snap fastening, and the like can be adopted.
  • the four mounting posts 68 of the lower cover 60 are interference fit with the four mounting holes 38 of the lower housing 30.
  • This interference fit causes the duckbill seal 50 to be in a compressed state.
  • the sleeve 32, the inner wall 36, the duckbill seal 50, the valve body 80 and the spool 82 together form a first chamber.
  • the duckbill seal 50 is a single slit, but other types of closure valves may be used, including a tongue valve and a multi-slot duckbill valve.
  • the duckbill seal 50 When the external instrument passes through the duckbill seal 50, its duckbill 53 can be opened, but it typically does not provide a complete seal with respect to the instrument. When the instrument is removed, the duckbill 53 automatically closes, thereby preventing fluid in the first chamber from leaking out of the body.
  • FIG. 5 depicts the composition and assembly relationship of the second seal assembly 200.
  • the sealing film assembly 180 is sandwiched between the upper cover 110 and the upper casing 190.
  • the proximal end 132 of the sealing membrane assembly 180 is secured between the inner ring 116 of the upper cover 110 and the inner ring 196 of the upper housing 190.
  • There are various ways of fixing between the upper casing 190 and the upper cover 110 Can be used for interference fit, ultrasonic welding, gluing, snap fastening, etc.
  • This embodiment shows that the outer casing 191 of the upper casing 190 and the outer casing 111 of the upper cover 110 are connected by ultrasonic welding. This fixation causes the proximal end 132 of the sealing membrane assembly 180 to be in a compressed state.
  • the central opening 113 of the upper cover 110, the inner ring 116 and the sealing membrane assembly 180 together form a second chamber.
  • the sealing film assembly 180 includes a lower fixing ring 120, a sealing film 130, a protection device 160, and an upper fixing ring 170.
  • the sealing film 130 and the protection device 160 are sandwiched between the lower fixing ring 120 and the upper fixing ring 170.
  • the post 121 of the lower retaining ring 120 is aligned with the corresponding aperture in the other components of the assembly 180.
  • the post 121 is interference fit with the aperture 171 of the upper retaining ring 170 such that the entire sealing membrane assembly 180 is in a compressed state.
  • the protective device 160 includes four sequentially overlapping protective sheets 163 for protecting the central sealing body of the sealing film 130 from perforations or tears caused by the sharp edges of the inserted surgical instrument.
  • the sealing membrane 130 includes a proximal opening 132, a distal opening 133, and a sealing wall extending proximally from the distal end, the sealing wall having a proximal end surface and a distal end surface.
  • the distal aperture 133 is formed by a sealing lip 134 for receiving an inserted instrument and forming a hermetic seal.
  • the sealing lip 134 may be non-circular, and the sealing lip 134 in this example is approximately circular. As described in the background of the invention, the circumference of the sealing lip should be short and strong enough to ensure sealing reliability when applying a 5 mm instrument.
  • the sealing lip 134 is circular, and its radius is defined as R lip .
  • the sealing lip has a circular cross section and a radius of usually 0.35 to 0.5 mm.
  • the sealing film 130 further includes a flange 136; the sealing wall 135 has one end connected to the sealing lip 134 and the other end connected to the flange 136; the floating portion 137 has one end connected to the flange 136 and the other end connected to the proximal end 132.
  • the flange 136 is used to mount a protective device.
  • the floating portion 137 includes one or more radial (lateral) pleats such that the entire sealing membrane assembly 180 can float within the assembly 200.
  • the assembly 180 can be made from a number of materials having different characteristics.
  • the sealing film 130 is made of a superelastic material such as silica gel or isoprene rubber;
  • the protective device 160 is a semi-rigid thermoplastic elastomer;
  • the lower fixing ring 120 and the upper fixing ring 170 are made of a relatively hard plastic material such as polycarbonate.
  • FIGS 8-11 depict the sealing film 130 of the first embodiment of the present invention in more detail.
  • the sealing film 130 is preferably designed as a single unit, but can also be designed as two parts, an inner sealing body and an outer floating portion, which are separated from the flange 136.
  • Embodiment 1 is mainly directed to the improvement of the inner seal body.
  • the outer floating portion and the proximal end are not shown in the subsequent description of the sealing film.
  • the axis of the sealing lip 134 is defined as 158.
  • a transverse plane 159 is defined that is substantially perpendicular to the axis 158.
  • the sealing wall 135 can be approximately frustoconical, approximately hemispherical, or an irregularly curved surface.
  • the sealing wall 135 in this example is formed in an approximately conical arrangement around the sealing lip 134.
  • the sealing wall 135 includes a plurality of approximately V-shaped pleats 140. The V-shaped pleats 140 and the sealing lip 134 are circumscribed and extend laterally away from the axis 158.
  • the V-shaped pleats 140 include pleat peaks 142a, 142b; pleat valleys 143a, 143b; and pleat walls 141 extending from the pleat peaks to the pleat valleys.
  • the pleat peaks 142a, 142b are not straight lines but wavy lines containing peaks and troughs.
  • the pleat valleys 143a, 143b are not straight lines, but rather wavy lines containing peaks and troughs.
  • the waves of the wavy lines 142a (142b) and 143a (143b) extend laterally in a direction away from the axis 158, referred to as lateral pleats (or radial pleats).
  • the V-shaped pleats 140 generally distribute approximately uniformly around the sealing lip 134, referred to as circumferential pleats (or tangential pleats).
  • the V-shaped pleats 140 are "multi-dimensional pleats" formed by stacking lateral pleats and tangential pleats.
  • the sealing lip 134 has a cylindrical portion that intersects the V-shaped pleats 140 to form an approximate triangular wall 139 having a proximally directed tip that opposes each pleat peak 142a (142b).
  • the sealing film 130 containing the V-shaped pleats 140 has the advantage of increasing the circumferential circumference of the vicinity of the sealing lip, helping to reduce the tightening force when applying a large-diameter instrument, thereby reducing the frictional resistance.
  • This example contains 8 pleats, with more or less pleats acting to increase the circumference of the adjacent area of the sealing lip. Since the V-shaped pleats 140 are formed by the superposition of the lateral pleats and the circumferential pleats, the pleats in the vicinity of the sealing lip have a greater degree of freedom.
  • the sealing body in the region outside the vicinity of the sealing lip is only less pulled or squeezed, helping to reduce overall deformation.
  • the V-shaped pleats 140 cause the sealing wall 135 to produce less lateral force to the instrument as the instrument moves laterally, helping to enhance sealing reliability.
  • the sealing film 130 has a defect that the sealing film 130 has a small tensile rigidity along the axial direction of the sealing lip, and it is similar to a spring when deformed by the tensile force, which causes the stick-slip described in the background to be more conspicuous.
  • a second embodiment of the sealing film 230 is depicted in more detail in Figures 12-15.
  • the numerical designations of the geometrical structures in Figures 12-15 are the same as the corresponding numerical references in Figures 8-11, indicating that the structures of the same numerical reference numerals in Example 2 and Example 1 are substantially identical.
  • the sealing film 230 includes a distal end aperture 133, a sealing lip 134, a sealing wall 135 and a flange 136.
  • the sealing film 230 has a proximal end surface and a distal end surface.
  • the axis of the sealing lip 134 is defined as 158.
  • a transverse plane 159 is defined that is perpendicular to the axis 158.
  • the sealing wall 135 includes a plurality of V-shaped pleats 140 and a plurality of reinforcing ribs 250.
  • the V-shaped pleats 140 and the sealing lip 134 are circumscribed and extend laterally away from the axis 158.
  • the V-shaped pleats 140 include pleat peaks 142a, 142b; pleat valleys 143a, 143b; and pleat walls 141 extending from the pleat peaks to the pleat valleys.
  • the pleat peaks 142a, 142b are not straight lines but wavy lines containing peaks and troughs.
  • the pleat valleys 143a, 143b are not straight lines, but rather wavy lines containing peaks and troughs.
  • the V-shaped pleats 140 are formed by stacking lateral pleats and tangential pleats "Multidimensional folds".
  • the sealing lip 134 has a cylindrical portion that intersects the V-shaped pleats 140 to form an approximate triangular wall 139 having a proximally directed tip that opposes each pleat peak 142a (142b).
  • the rib 250 extends laterally from the sealing lip 134 to the wall portion 138.
  • the ribs 250 extend laterally along the pleat peaks, or may extend laterally along the pleat valleys or laterally at an angle to the pleat peaks (pleat valleys).
  • the reinforcing rib 250 in the present example is a proximal end projection of the pleats 140 and extends laterally outward to the flange, but may also be convex from the distal end surface of the pleats 140 or simultaneously convex from the proximal end surface and the distal end surface.
  • the sidewall 252 of the stiffener 250 in this example is planar and approximately parallel to the axis 158, but may not be parallel to the axis.
  • the width of the rib 250 in this example is less than the minimum width of one pleat of the V-shaped pleats 140.
  • the rib 250 acts to pull the sealing lip 134 and its adjacent regions. This pulling action enhances the axial tensile stiffness of the entire sealing wall 135. When the instrument is inserted, the axial displacement of the sealing lip 134 is small. This example contains 4 stiffeners. More or less stiffeners can also play a similar role.
  • the sealing film 230 having the reinforcing ribs 250 has an effect of increasing the circumferential circumference of the sealing film 130, reducing the frictional resistance, reducing the overall deformation and reducing the lateral force, and reducing the axial stiffness. Small, sticky and slippery.
  • the sealing film 330 includes a distal end aperture 133, a sealing lip 134, a sealing wall 135 and a flange 136.
  • the sealing film 230 has a proximal end face A and a distal end face B.
  • the axis of the sealing lip 134 is defined as 158.
  • a transverse plane 159 is defined that is perpendicular to the axis 158.
  • the sealing wall 135 includes a plurality of approximately V-shaped pleats 140 and a plurality of reverse grooves 350 (or hollow ribs 350).
  • the V-shaped pleats 140 and the sealing lip 134 are circumscribed and extend laterally away from the axis 158.
  • the V-shaped pleats 140 include pleat peaks 142a, 142b; pleat valleys 143a, 143b; and pleat walls 141 extending from the pleat peaks to the pleat valleys.
  • the pleat peaks 142a, 142b are not straight lines but wavy lines containing peaks and troughs.
  • the pleat valleys 143a, 143b are not straight lines, but rather wavy lines containing peaks and troughs.
  • the V-shaped pleats 140 are "multi-dimensional pleats" formed by stacking lateral pleats and tangential pleats.
  • the sealing lip 134 has a cylindrical portion that intersects the V-shaped pleats 140 to form an approximately triangular wall (or trapezoidal surface) 139 having a proximally directed tip opposite each of the pleat peaks 142a (142b).
  • a plurality of reverse grooves 350 extend laterally outward from the sealing lip 134 to the wall portion 138.
  • the reverse groove 350 is recessed from the distal end surface of the pleats 140 toward the proximal end surface and the opening faces the distal end surface.
  • the reverse groove 350 is concave from the perspective of the distal end surface, and is close to Viewed from the perspective of the end face A, the reverse groove 350 is a rib that is raised from the sealing body.
  • the reverse groove 350 includes an inner sidewall 351 and a sidewall 352.
  • the inner sidewall 351 and the side wall 352 intersect Lines 355a, 355b; the side walls 352 intersect the pleat walls 141 to form intersection lines 356a, 356b.
  • the inner side wall 351 has one end of the side wall 352 that intersects the sealing lip 134 and the other end that intersects the wall portion 138.
  • the plurality of V-shaped pleats 140 and the plurality of reverse grooves 340 together form a seamless sealing wall 135.
  • the side wall 352 of the reverse groove is a non-pleated plane; its function is equivalent to the rib 250 described in the second embodiment.
  • the inner side wall 351 is also planar in this example, however the inner side wall may also be a wrinkled curved surface.
  • the V-shaped pleats 140 and the reverse groove 350 together increase the circumferential circumference of the adjacent region of the sealing lip; the V-shaped pleats 140 can reduce the overall deformation of the sealing lip; and the reverse groove 350 can To the role of pulling the sealing lip 134 and its adjacent area. This pulling action enhances the axial tensile stiffness of the entire sealing wall 135. When the instrument is inserted, the axial displacement of the sealing lip 134 is small. Therefore, the sealing film 330 has an effect of increasing the circumferential circumference, reducing the overall deformation and reducing the lateral force, increasing the axial tensile rigidity, and the like. It can reduce friction, improve stick slip and improve sealing reliability.
  • the sealing film 430 includes a distal end 433, a sealing lip 434, a sealing wall 435 and a flange 436.
  • the distal aperture 433 is formed by a sealing lip 434.
  • the sealing wall 435 has a sealing lip 434 at one end and a wall portion 438 of the flange 436 at the other end.
  • the sealing film 430 has a proximal end surface and a distal end surface.
  • the axis of the sealing lip 434 is defined as 158.
  • a transverse plane 159 is defined that is perpendicular to the axis 158.
  • the sealing wall 435 includes a plurality of approximately U-shaped pleats 440 and a plurality of opposing grooves 450 (or hollow ribs 450).
  • the U-shaped pleats 440 and the sealing lip 434 are circumscribed and extend laterally outward.
  • the U-shaped pleats 440 include an inner pleat wall 441, an outer pleat wall 443, and a pleated sidewall 442 that connects the inner pleat wall 441 and the outer pleat wall 443.
  • the inner pleated wall 441 intersects the pleated sidewall 442 to form an intersection line 445a, 445b; the outer pleat wall 443 intersects the pleated sidewall 442 to form an intersection line 446a, 446b.
  • the intersection line 445a (445b) and the intersection line 446a (446b) are not straight lines but wavy lines containing peaks and troughs.
  • the waves of the wavy lines 445a (445b) and 446a (446b) extend laterally in a direction away from the axis 458, referred to as lateral pleats (or radial pleats).
  • the U-shaped pleats 440 generally have an approximately uniform distribution around the sealing lip 434, referred to as tangential pleats (or circumferential pleats).
  • the U-shaped pleats 440 are "multi-dimensional pleats" in which lateral pleats and tangential pleats are superposed.
  • a plurality of reverse grooves 450 extend laterally outward from the sealing lip 434 to the wall portion 438.
  • the reverse groove 450 is recessed from the distal end surface of the pleat 440 toward the proximal end surface, and the reverse groove 450 is concave from the perspective of the distal end surface, and from the perspective of the proximal end surface,
  • the reverse groove 450 is a rib that is raised from the sealing body.
  • the reverse groove 450 includes an inner sidewall 451 and a sidewall 452.
  • the inner side wall 451 and the side wall 452 intersect to form an intersection line 455a, 455b; the side wall 452 intersects the outer pleat wall 443 to form an intersection line 456a, 456b.
  • the plurality of U-shaped pleats 440 and the plurality of reverse grooves 450 together form a seamless sealing wall 435.
  • the side wall 452 of the reverse groove 450 is a non-pleated plane; its function is equivalent to the rib 250 described in the second embodiment.
  • the inner side wall 451 is also planar in this example, however the inner side wall may also be a wrinkled curved surface.
  • the U-shaped pleats 440 and the reverse groove 450 together increase the circumferential circumference of the adjacent region of the sealing lip; the U-shaped pleats 440 can reduce the overall deformation of the sealing lip; and the reverse groove 450 can To the role of pulling the sealing lip 434 and its adjacent area. This pulling action enhances the axial tensile stiffness of the entire sealing wall 435. The axial displacement of the sealing lip 434 is then small when the instrument is inserted. Therefore, the sealing film 430 has an effect of increasing the circumferential circumference, reducing the overall deformation and reducing the lateral force, increasing the axial tensile rigidity, and the like. It can reduce friction, improve stick slip and improve sealing reliability.
  • the reverse groove extends laterally outward from the sealing lip, and the so-called "laterally outwardly extending" should not be limited to a straight line whose extension trajectory is straight.
  • the trajectory can also be a curve such as a spiral line, a broken line segment, or a multi-segment arc line.
  • the positional relationship of the intersecting faces constituting the reverse groove and the intersection line thereof are described in detail, and the addition of the curved surface to form the multi-faceted splicing or the use of the high-order curved surface to make the intersection line and the groove may be used.

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Abstract

一种含多维褶皱的穿刺器密封膜（130），密封膜（130）包括近端开口（132）和远端孔（133）以及从远端孔（133）延伸至近端开口（132）的密封壁（135），密封壁（135）具有近端面和远端面。远端孔（133）由密封唇（134）形成，用于容纳插入的器械并形成气密封。在密封唇（134）临近区域，密封壁（135）同时具有多个从密封唇（134）横向向外延伸的横向褶皱和围绕密封唇（134）均布的切向褶皱。褶皱型的密封壁（135）可增加密封唇（134）临近区域的环向周长和有助于减小应用大直径器械时的总体变形，从而减小摩擦力和提高密封可靠性。

Description

一种含多维褶皱的穿刺器密封膜 技术领域
本发明涉及微创手术器械，尤其涉及一种穿刺器密封结构。
背景技术
穿刺器是一种微创手术中(尤其是硬管腔镜手术)，用于建立进入体腔的人工通道的手术器械。通常由套管组件和穿刺针组成。其临床的一般使用方式为：先在患者皮肤上切开小口，再将穿刺针贯穿套管组件，然而一起经皮肤开口处穿透腹壁进入体腔。一旦进入体腔后穿刺针被取走，留下套管组件作为器械进出体腔的通道。
硬管腔镜手术中，通常需建立并维持稳定的气腹，以获得足够的手术操作空间。套管组件通常由套管，外壳，密封膜(亦称器械密封)和零密封(亦称自动密封)组成。所述套管从体腔外穿透至体腔内，作为器械进出体腔的通道。所述外壳将套管、零密封和密封膜连接成一个密封系统。所述零密封通常不提供对于插入器械的密封，而在器械移走时自动关闭并形成密封。所述密封膜在器械插入时箍紧器械并形成密封。
一种典型的内窥镜手术中，通常在患者腹壁建立4个穿刺通道，即2个小内径套管组件(通常5mm)和2个大内径套管组件(通常10～12mm)。通常经由小内径套管组件进入患者体内的器械仅完成辅助操作；其中一个大内径套管组件作为内窥镜通道；而另一个大内径套管组件作为医生进行手术的主要通道。在此所述主要通道，约80％的时间应用5mm器械；约20％的时间应用其他大直径器械；且手术中5mm器械与大直径器械需频繁切换。应用小直径器械时间最长，其密封可靠性较重要；应用大直径器械时往往为手术中的关键阶段(例如血管闭合和组织缝合)，其切换便捷性和操作舒适性较重要。
图1和图2描绘了现有一种典型的12mm规格的套管组件700。所述套管组件700包含下壳710，上壳720和夹在所述上壳720和下壳710之间密封膜730，鸭嘴密封750。所述下壳710包含细长管711限定的中心通孔713。所述上壳720包含内壁721限定的近端孔723。所述密封膜730包含近端开口732，远端孔733，密封唇734，截圆锥密封壁735，凸缘736和外部浮动部分737。所述远端开口733由密封唇734形成。定义密封唇的轴线为741，定义大体垂直于轴线741的横平面742；定义截圆锥密封壁735的回转母线与所述横平面742的夹角为导向角ANG1。
如图1，插入5mm器械时，近似认为仅密封唇734变形产生的环箍紧力保证对于器械的可靠密封。而进行手术时，常需从各个极限的角度操作器械。5mm器械在12mm 套管中有很大径向活动空间，这使得密封唇734径向受力较大。因此密封唇734对于插入的5mm器械应有足够的环箍紧力才能保证其密封可靠性。
如图2，作一个直径为Di(Di＞5mm)的圆柱与所述密封壁735相交，形成直径为Di的交线738。本领域技术人员一定可以理解，若插入直径为Di的器械，则所述密封壁735从密封唇734到交线738的区域的应变(应力)较大，称此区域为密封唇临近区域(或应力集中区域)；而所述密封壁735从交线738到凸缘736的区域其应变(应力)较小。插入器械的直径Di不同，所述密封唇临近区域(应力集中区域)的边界范围大小不同。为方便量化，定义当Di为设计通过密封膜的手术器械的最大直径时，从密封唇734到所述交线738的区域为密封唇临近区域。
如图3，插入大直径器械时(例如12.8mm)，所述密封唇734将胀大到合适的尺寸以容纳插入的器械；所述密封壁735被分成圆锥壁735c和圆柱壁735d两部分；所述圆柱壁735d包裹在器械外表面上，形成应力高度集中的包裹区域。定义圆锥壁735c和圆柱壁735d的交线为738a；当移除器械后，恢复为自然状态下的所述密封壁735，定义所述交线738a回弹为半径为Dx的圆环738b(图中未示出)；所述交线738b即插入大直径器械时的弯曲分界线。定义所述圆锥壁735c的回转母线与所述横平面742的夹角为ANG2，且ANG2＞ANG1；即插入大直径器械时所述密封壁735以凸缘736和密封壁735的交线为支点旋转舒张。定义所述圆柱壁735d的高度为Ha。所述Ha不是定值，所述远端孔大小不同，所述密封唇尺寸不同，所述密封壁壁厚不同，所述导向角不同或插入器械直径不同等因素都将导致Ha不同。
当手术中操作插入密封膜中的器械移动时，所述包裹区域与插入器械之间存在较大摩擦阻力。所述较大摩擦阻力通常容易造成密封膜内翻，操作舒适性差，操作疲劳，甚至导致套管组件在患者腹壁上固定不牢靠等缺陷，影响套管组件的使用性能。
所述摩擦阻力较大导致的缺陷中，密封膜内翻是影响套管组件使用性能最严重的问题之一。如图4，当向外拔出大直径器械时，容易发生密封膜内翻。内翻后的所述密封壁735被分成圆柱壁735e，圆锥壁735f，圆锥壁735g；所述圆柱壁735e包裹在器械外表面，形成应力高度集中的包裹区域。定义所述圆柱壁735e的高度为Hb，通常Hb大于Ha；即拔出器械时的摩擦阻力大于插入器械时的摩擦阻力；这种差异影响手术医生操作体验甚至导致手术医生产生错觉。更严重的，内翻后的密封膜可能进入近端孔723，即密封膜堆积在器械与所述内壁721之间导致卡死。美国专利US7112185,US7591802中分别披露了防止密封膜内翻的措施；这些措施可有效的降低内翻概率但不能彻底解决内翻问题。
减小所述摩擦阻力，最简单的方法是采用润滑脂降低两接触面间的摩擦系数。但该措施的可靠性不好。临床应用时，由于器械长期的反复的与密封膜刮擦，以及多种器械的反复切换，容易使润滑脂从密封膜表面脱离并被带走，从而导致润滑不良。
美国专利US5342315中披露了一种紧贴密封膜的保护片。所述保护片既可避免器械的锋利边损坏密封膜，又因保护片表面摩擦系数小于密封膜表面摩擦系数，因此能一定程度的降低所述摩擦阻力。但所述密封唇临近区域通常不能被保护片完全覆盖。
美国专利US5827228中披露了一种含筋的密封膜，即密封膜从中心孔附近开始，具有数个径向发散的筋，所述筋减小插入器械与密封膜之间的接触面积，从而减小所述摩擦阻力。欧洲专利EP0994740中披露了一种近似的加强筋具有减小接触面积和增加密封膜轴向抗拉强度的作用。
美国专利US7842014中披露了一种褶皱形密封膜，其主要特征是具有波浪形的密封唇和波浪形褶皱密封体。所述褶皱结构能够增大环向周长，一定程度的降低环箍紧力。
中国发明申请CN101480354A(目前已被驳回)中披露了一种含有易变形槽的密封膜，从密封唇开始，在密封膜的圆锥面上具有数个易变形槽；所述易变形槽的壁厚远小于所述圆锥面的壁厚；主要由易变性槽的伸长变形来容纳插入的大直径器械。
虽然现有技术中已披露很多减小所述摩擦阻力的方案，但已披露的技术方案基本上仅从影响摩擦阻力的某一个因素着眼提出解决方案，其降低摩擦阻力的效果较小或不明显。一些方案中甚至因改善一个因素而引入其他缺陷。例如密封膜上增加加强筋可减少接触面积，但同时会增加环箍紧力；例如采用厚度远小于截圆锥面的易变形槽，会导致易变形槽处容易被损坏；例如若采用波浪形密封唇增加了密封膜开口处的环向周长，从而牺牲了应用5mm器械时的密封可靠性，若采用波浪形的密封唇却不增加密封膜开口处的环向周长，则波浪密封唇相对于纯圆形的密封唇已经失去改善作用。总之。影响所述摩擦阻力的因素很多，须从力学和摩擦学的角度考量各个因素的综合作用。
密封膜通常由天然橡胶、硅橡胶、异戊橡胶等橡胶材料制成，橡胶材料具有超弹性和粘弹性。虽然橡胶变形过程的力学模型很复杂，但仍可近似的用广义胡克定律描述其弹性行为；用牛顿内摩擦定律描述其粘性行为。研究表明，影响橡胶与器械接触产生摩擦力的主要因素包括：两接触面的摩擦系数越小则摩擦力越小；两接触面间的润滑条件越好则摩擦力越小；两接触面间的真实接触面积越小则摩擦力越小；两接触面间的法向压力越小则摩擦力越小。本发明综合考虑上述因素，提出更完善的减小密封膜与插入器械之间摩擦阻力的解决方案。
除了前述摩擦阻力较大影响套管组件使用性能之外，密封膜粘滑也是影响穿刺器使用性能的另一重要因素。所述粘滑，即器械在套管中轴向移动时，密封膜的密封唇及其临近区域时而相对静止地粘附于器械之上(此时器械与密封膜之间的摩擦力主要是静摩擦力)；时而又与器械产生相对滑动的现象(此时器械与密封膜之间的摩擦力主要是动摩擦力)；且所述静摩擦力远大于所述动摩擦力。所述静摩擦和动摩擦交替出现，这导致器械在密封膜中移动的阻力不稳定和移动速度不平稳。本领域技术人员可以理解，微创手术中，医生只能使用器械触及患者内脏器官，并借助内窥镜影像系统监视器械工作头部的局部范围。在这种视野受限，触觉阻断的情况下，手术医生通常把移动器械时的阻力反馈作为判定手术操作是否正常的信息之一。密封膜粘滑影响了操作的舒适性、定位准确性，甚至诱发医生错误的判断。
在套管组件的使用过程中，所述粘滑很难完全避免，但可以被减小。研究表明，所述粘滑受两个主要因素影响：其一是最大静摩擦力和动摩擦力差值越小则粘滑越微弱；其二是密封膜的轴向抗拉刚度越大则粘滑越微弱。避免密封膜与器械之间的环箍紧力过大，减小密封膜和器械间的真实接触面积，保持密封膜与器械之间的良好润滑，均可以减小最大静摩擦力与动摩擦力的差值，从而减小粘滑。同时增加密封膜的轴向抗拉刚度，也有助于减轻粘滑现象。本发明同时提出了改善粘滑的措施。
综上所述，到目前为止，还没有一种能有效解决前述问题的套管组件。
发明内容
因此，本发明的一个目的是提供一种穿刺器密封膜，所述密封膜包括近端开口和远端孔以及由近端向远端延伸的密封壁。所述远端孔由密封唇形成，用于容纳插入的器械并形成密封。所述密封唇包含中心轴线和大致与所述轴线垂直的横平面。所述密封壁具有近端面和远端面。该密封膜能在确保对于插入的5mm器械可靠密封的前提下，降低应用大直径器械时的摩擦阻力和改善粘滑。
本发明的一个目的是提供一种含多维褶皱的穿刺器密封膜，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面；所述远端孔由密封唇形成，用于容纳插入的器械并形成气密封；在密封唇临近区域，所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱。
优选的，所述密封壁还包含从密封唇开始的横向向外延伸的实心筋。
优选的，所述密封壁还包含从密封唇开始的横向向外延伸的从密封壁远端面向近端面凹陷的开口朝向远端面的反向凹槽，从近端面的视角看所述反向凹槽是从近端面凸起的 筋，且所述反向凹槽包含两个平面的无褶皱的侧壁。
优选的，所述切向褶皱的截面是U型的。
优选的，所述切向褶皱的截面是V型的。
优选的，包含4个所述反向凹槽。
优选的，所述密封唇是圆环形的或圆柱形的。
优选的，还包括与所述褶皱和所述筋同时相交的凸缘，以及从凸缘延伸至近端开口的包括多个横向褶皱的浮动部分。
本发明的另一个目的是提供一种穿刺器密封组件，包括所述的密封膜，所述密封组件还包含下固定环，上固定环，保护装置，上壳体和上盖；所述密封膜还包括与所述褶皱和所述筋同时相交的凸缘，以及从凸缘延伸至近端开口的包括至少一个横向褶皱的外部浮动部分；所述密封膜和保护装置被夹在上固定环和下固定环之间，所述密封膜的近端开口被夹在上壳体和上盖之间。
如背景所述，密封唇及其临近区域在插入大直径器械时形成的圆柱包裹区是造成摩擦阻力较大的根源。要降低所述摩擦阻力，应综合考虑减小器械与密封膜之间的径向应力，减小器械与密封膜之间的圆柱包裹区域，减小器械与密封膜的真实接触面积。本领域技术人员可以理解，根据广义胡可定律和泊松比理论可知，增加环向周长可以降低环向应变(应力)，从而降低径向应变(应力)。但应注意到不可通过增加环向周长的方法来降低密封唇的应变(应力)，这将导致应用5mm器械时的密封可靠性降低。而由于密封唇临近区域在应用大直径器械时的应力高度集中，因此应该快速的增大密封唇临近区域的环向周长；对于密封唇临近区域之外的区域，由于应变(应力)较小，可以不必采用增大环向周长的措施。另外，增大环向周长的同时还应增加密封唇临近区域的轴向抗拉刚度以求改善密封唇临近区域的粘滑现象。
在本发明的一个方面，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面。所述远端孔由密封唇形成，用于容纳插入的器械并形成气密封。在密封唇临近区域，所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱。所述褶皱型的密封壁可增加密封唇临近区域的环向周长和有助于减小应用大直径器械时的总体变形，从而减小摩擦力和提高密封可靠性。
在本发明的另一个方面，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面。所述远端孔由密封唇形成，用于容 纳插入的器械并形成气密封。在密封唇临近区域，所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱。所述密封壁还包含从密封唇开始的横向向外延伸的实心筋，所述实心筋可以增强密封唇临近区域的轴向抗拉刚度从而能改善粘滑。
在本发明的又一个方面，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面。所述远端孔由密封唇形成，用于容纳插入的器械并形成气密封。在密封唇临近区域，所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱。所述密封壁还包含从密封唇开始的横向向外延伸的从密封壁远端面向近端面凹陷的开口朝向远端面的反向凹槽，从近端面的视角所述反向凹槽是从近端面凸起的筋；且所述反向凹槽包含两个平面的无褶皱的侧壁。所述切向褶皱的截面是近似V型的；而所述反向凹槽的截面形状是近似U型的；所述密封唇是圆柱形的。所述密封膜还包括与所述横向褶皱，切向褶皱和所述反向凹槽同时延伸相交的凸缘，以及从凸缘延伸至近端开口的包含多个横向褶皱的外部浮动部分。所述褶皱型密封壁和所述反向凹槽共同增加了密封唇临近区域的环向周长，有助于减小所述摩擦阻力。同时所述反向凹槽增加了密封唇临近区域的轴向抗拉刚度，因此能改善所述粘滑。
在本发明的又一个方面，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面。所述远端孔由密封唇形成，用于容纳插入的器械并形成气密封。所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱；所述密封壁还包含从密封唇开始的横向向外延伸的从密封壁远端面向近端面凹陷的开口朝向远端面的反向凹槽，从近端面的视角所述反向凹槽是从近端面凸起的筋；且所述反向凹槽包含两个平面的无褶皱的侧壁。所述切向褶皱的截面的形状是近似U型的；而所述反向凹槽的截面形状是近似U型的；所述密封唇是圆环形的。所述褶皱型密封壁和所述反向凹槽共同增加了密封唇临近区域的环向周长，有助于减小所述摩擦阻力。同时所述反向凹槽增加了密封唇临近区域的轴向抗拉刚度，因此能改善所述粘滑。
本发明的另一个目的是提供一种穿刺器密封组件。所述密封组件包含下固定环，密封膜，保护装置，上固定环，上壳体和上盖组成。所述密封膜和保护装置被夹在下固定环之间，所述保护装置用于保护所述密封膜免受插入器械的锋利边损害。所述密封膜的近端被夹在上壳体和上盖之间，所述密封膜的外部浮动部分可使得所述密封膜及保护装置可以在上壳体和上盖形成的密封仓内横向移动。
当参考附图及详细说明是，本发明的上述的或其他的目的，特征和优点将变得更加清楚。
附图说明
为了更充分的了解本发明的实质，下面将结合附图进行详细的描述，其中：
图1是现有技术的套管组件插入5mm器械时的模拟变形图；
图2是现有技术的密封膜730的详图；
图3是现有技术的套管组件插入12.8mm器械时的模拟变形图；
图4是现有技术的套管组件拔出12.8mm器械时的模拟变形图；
图5是本发明套管组件的立体的局部的剖视图；
图6是图5所述套管组件中的密封膜组件的分解图；
图7是图6所示密封膜组件的立体局部剖视图；
图8是图6所示密封膜略去近端和浮动部分之后的密封膜立体图；
图9是图8所示密封膜的反方向立体剖视图；
图10是图8所示密封膜的10-10剖视图；
图11是图8所示密封膜的11-11剖视图；
图12是本发明第二个实施例的密封膜立体图；
图13是图12所示密封膜的反方向立体图；
图14是图12所示密封膜的14-14剖视图；
图15是图12所示密封膜的15-15剖视图；
图16是本发明的第三个实施例的密封膜立体图；
图17是图16所示密封膜的反方向立体图；
图18是图16所示密封膜的18-18剖视图；
图19是图16所示密封膜的19-19剖视图；
图20是本发明的第四个实施例的密封膜立体图；
图21是图20所示密封膜的反方向立体图；
图22是图20所示密封膜的22-22剖视图；
图23是图20所示密封膜的23-23剖视图；
图24是图20所示密封膜的24-24剖视图；
图25是图21所示密封膜的倒圆角后的示意图；
在所有的视图中，相同的标号表示等同的零件或部件。
具体实施方式
这里公开了本发明的实施方案，但是，应该理解所公开的实施方案仅是本发明的示例，本发明可以通过不同的方式实现。因此，这里公开的内容不是被解释为限制性的，而是仅作为权利要求的基础，以及作为教导本领域技术人员如何使用本发明的基础。
图5描绘了穿刺器的整体结构。一种典型穿刺器包含穿刺针10(未示出)和套管组件20。套管组件20具有开放的近端192和开放的远端31。一种典型的应用中，穿刺针10贯穿套管组件20，然后一起经皮肤开口处穿透整个腹壁进入体腔。一旦进入体腔，穿刺针10被取走并留下套管组件20作为器械进出体腔的通道。所述近端192处于患者体外而所述远端31处于患者体内。一种优选的套管组件20，可划分成第一密封组件100和第二密封组件200。所述组件100的卡槽39和所述组件200的卡勾112配合扣紧。所述卡勾112和卡槽39的配合是可单手快速拆分的。这主要为了手术时方便取出患者体内的组织或异物。所述组件100和组件200之间的快锁连接有多种实现方式。除本实施例展示的结构外，还可采用螺纹连接，旋转卡扣或者其他快锁结构。可选择的，所述组件100和组件200可以设计成不可快速拆分的结构。
图5描绘了第一密封组件100的组成和装配关系。下壳体30包括一细长管32，该细长管限定出贯穿远端31的套管33并与外壳34相连。所述下壳体30具有支撑鸭嘴密封的内壁36和与内壁联通的气阀安装孔37。阀芯82安装在阀体80中并一起安装在所述安装孔37中。鸭嘴密封50的凸缘56被夹在所述内壁36和下盖60之间。所述下盖60与下壳体30之间的固定方式有多种，可采用过盈配合，超声波焊接，胶接，卡扣固定等方式。本实施例中所述下盖60的4个安装柱68与所述下壳体30的4个安装孔38过盈配合，这种过盈配合使鸭嘴密封50处于压缩状态。所述套管32，内壁36，鸭嘴密封50，阀体80和阀芯82共同组成了第一腔室。本实施例中，所述鸭嘴密封50是单缝，但也可以使用其他类型的闭合阀，包括舌型阀，多缝鸭嘴阀。当外部器械贯穿所述鸭嘴密封50时，其鸭嘴53能张开，但是其通常不提供相对于所述器械的完全密封。当所述器械移走时，所述鸭嘴53自动闭合，从而防止第一腔室内的流体向体外泄露。
图5描绘了第二密封组件200的组成和装配关系。密封膜组件180夹在上盖110和上壳体190之间。所述密封膜组件180的近端132被固定在所述上盖110的内环116和所述上壳体190的内环196之间。所述上壳体190和上盖110之间的固定方式有多种， 可采用过盈配合，超声焊接，胶接，卡扣固定等方式。本实施例展示连接方式为的所述上壳体190的外壳191与所述上盖110的外壳111之间通过超声波焊接固定。这种固定使得所述密封膜组件180的近端132处于压缩状态。所述上盖110的中心孔113，内环116和密封膜组件180一起组成了第二腔室。
图6-7描绘了密封膜组件180的组成和装配关系。所述密封膜组件180包含下固定环120，密封膜130，保护装置160和上固定环170。所述密封膜130和保护装置160被夹在下固定环120和上固定环170之间。而且所述下固定环120的柱子121与所述组件180中其他部件上相应的孔对准。所述柱子121与上固定环170的孔171过盈配合，从而使得整个密封膜组件180处于压缩状态。所述保护装置160包含4个顺序搭接的保护片163，用于保护所述密封膜130的中心密封体，使其免受插入的手术器械的锋利边造成的穿孔或撕裂。
所述密封膜130包括近端开口132，远端开孔133以及从远端向近端延伸的密封壁，所述密封壁具有近端面和远端面。所述远端孔133由密封唇134形成，用于容纳插入的器械并形成气密封。所述密封唇134可以是非圆形的，本实例中所述密封唇134是近似圆环形的。如发明背景所述，密封唇周长应足够短且粗壮以确保应用5mm器械时的密封可靠性。本实例中密封唇134为圆形，定义其半径为Rlip，则密封唇周长近似等于2*Rlip*π(π＝3.14159)，通常密封唇周长为11.8～13.8mm。所述密封唇的截面为圆形，其半径通常为0.35～0.5mm。
所述密封膜130还包括凸缘136；密封壁135一端连接密封唇134而另一端连接凸缘136；浮动部分137一端连接凸缘136而另一端连接所述近端132。所述凸缘136用于安装保护装置。所述浮动部分137包含一个或多个径向(横向)褶皱，从而使得整个密封膜组件180能够在所述组件200中浮动。
所述组件180可以由很多具有不同特性的材料制成。例如密封膜130采用硅胶，异戊橡胶等超弹性材料；保护装置160采用半刚性的热塑性弹性体；而下固定环120和上固定环170采用聚碳酸酯等相对较硬的塑胶材料制成。
图8-11更细致的描绘了本发明的第一个实施例密封膜130。为降低生产成本，密封膜130最好设计成一个整体，但也可以设计成从凸缘136处分开的内部密封体和外部浮动部分两个零件。实施例一主要针对所述内部密封体进行改进。为简化表述，后续描述密封膜时均不展示外部浮动部分和近端。
定义所述密封唇134的轴线为158。定义基本垂直于轴线158的横平面159。所述 密封壁135可以是近似截圆锥形，近似半球形，或不规则的旋转曲面。本实例中密封壁135以近似圆锥的方式围绕密封唇134排列形成。所述密封壁135包含多个近似V型褶皱140。所述V型褶皱140与密封唇134外切并向背离轴线158的方向横向延伸。所述V型褶皱140包括褶皱峰142a，142b；褶皱谷143a，143b；以及从褶皱峰延伸至褶皱谷的褶皱壁141。所述褶皱峰142a，142b不是直线，而是包含波峰和波谷的波浪线。同样，所述褶皱谷143a，143b也不是直线，而是包含波峰和波谷的波浪线。所述波浪线142a(142b)和143a(143b)的波浪是沿着背离轴线158的方向横向延伸的，称之为横向褶皱(或径向褶皱)。而所述V型褶皱140总体围绕密封唇134近似均匀的分布，称之环向褶皱(或切向褶皱)。所述V型褶皱140是横向褶皱和切向褶皱叠加而成的“多维褶皱”。所述密封唇134具有圆柱部分，该圆柱部分与所述V型褶皱140相交形成一个具有与每个褶皱峰142a(142b)对着的近侧指向尖端的近似三角壁139。
含有所述V型褶皱140的密封膜130，其优势在于增加了密封唇临近区域的环向周长，有助于减小应用大直径器械时的环箍紧力，从而减小所述摩擦阻力。本实例包含8个褶皱，更多或较少的褶皱都能起到增加密封唇临近区域周长的作用。由于所述V型褶皱140是横向褶皱和环向褶皱叠加而成，密封唇临近区域的褶皱有较大的自由度。当插入大直径器械迫使密封唇临近区域舒张变形时，密封唇临近区域之外的区域的密封体仅受到较小的牵拉或挤压，有助于减小总体变形。另外，当器械横向移动时，V型褶皱140使得密封壁135对于器械产生较小的横向力，有助于增强密封可靠性。但是，所述密封膜130存在一个缺陷，即密封膜130沿着密封唇的轴向抗拉刚度很小，其受拉力变形时类似一个弹簧，这将导致背景所述的粘滑更加明显。
图12-15更细致的描绘了的第二个实施例密封膜230。图12-15中几何结构的数字标号与图8-11中相应的数字标号相同，表示实例二与实例一中相同数字标号的结构是基本等同的。所述密封膜230包括远端孔133，密封唇134，密封壁135和凸缘136。所述密封膜230具有近端面和远端面。定义所述密封唇134的轴线为158。定义垂直于轴线158的横平面159。
所述密封壁135包含多个V型褶皱140和多个加强筋250。所述V型褶皱140与密封唇134外切并向背离轴线158的方向横向延伸。所述V型褶皱140包括褶皱峰142a，142b；褶皱谷143a，143b；以及从褶皱峰延伸至褶皱谷的褶皱壁141。所述褶皱峰142a，142b不是直线，而是包含波峰和波谷的波浪线。同样，所述褶皱谷143a，143b也不是直线，而是包含波峰和波谷的波浪线。所述V型褶皱140是横向褶皱和切向褶皱叠加而成 的“多维褶皱”。所述密封唇134具有圆柱部分，该圆柱部分与所述V型褶皱140相交形成一个具有与每个褶皱峰142a(142b)对着的近侧指向尖端的近似三角壁139。
所述加强筋250从密封唇134处横向延伸至壁部分138。本实例中加强筋250是沿着褶皱峰横向延伸的，也可以沿着褶皱谷横向延伸，或者与褶皱峰(褶皱谷)成一定角度的横向延伸。本实例中加强筋250是所述褶皱140的近端面凸起并横向向外延伸至凸缘的，然而也可以从褶皱140的远端面凸起或者同时从近端面和远端面凸起。本实例中所述加强筋250的侧壁252为平面并近似与轴线158平行，然而也可以不与轴线平行。本实例中所述加强筋250的宽度小于V型褶皱140的一个褶皱的最小宽度。
所述加强筋250起到牵拉密封唇134及其临近区域的作用。这种牵拉作用增强了整个密封壁135的轴向抗拉刚度。则插入器械时，所述密封唇134产生的轴向位移很小。本实例中包含4个加强筋。更多或较少的加强筋也可起到近似作用。具有加强筋250的密封膜230，具备与密封膜130近似的增大环向周长，减小摩擦阻力，减小总体变形和减小横向力等作用；同时由于增加了轴向刚度，可以减小所述粘滑。
图16-19详细描述了另一优选的实施例三密封膜330。图16-19中几何结构的数字标号与图8-11中相应的数字标号相同，表示实例三与实例一中相同数字标号的结构是基本等同的。所述密封膜330包括远端孔133，密封唇134，密封壁135和凸缘136。所述密封膜230具有近端面A和远端面B。定义所述密封唇134的轴线为158。定义垂直于轴线158的横平面159。
所述密封壁135包含多个近似V型褶皱140和多个反向凹槽350(或称空心筋350)。
所述V型褶皱140与密封唇134外切并向背离轴线158的方向横向延伸。所述V型褶皱140包括褶皱峰142a，142b；褶皱谷143a，143b；以及从褶皱峰延伸至褶皱谷的褶皱壁141。所述褶皱峰142a，142b不是直线，而是包含波峰和波谷的波浪线。同样，所述褶皱谷143a，143b也不是直线，而是包含波峰和波谷的波浪线。所述V型褶皱140是横向褶皱和切向褶皱叠加而成的“多维褶皱”。所述密封唇134具有圆柱部分，该圆柱部分与所述V型褶皱140相交形成一个具有与每个褶皱峰142a(142b)对着的近侧指向尖端的近似三角壁(或梯形面)139。
多个反向凹槽350从密封唇134开始横向向外延伸至壁部分138。所述反向凹槽350从所述褶皱140的远端面向近端面凹陷且开口朝向远端面，从远端面的视角看，所述反向凹槽350是下凹的，而从近端面A的视角看，所述反向凹槽350是从密封体上隆起的筋。所述反向凹槽350包含内侧壁351和侧壁352。所述内侧壁351和侧壁352相交形 成交线355a，355b；所述侧壁352与褶皱壁141相交形成交线356a，356b。所述内侧壁351，侧壁352的一端与密封唇134相交而另一端与壁部分138相交。所述多个V型褶皱140和多个反向凹槽340共同组成了无缝隙的密封壁135。本实例中有8个V型褶皱140和4个反向凹槽350，然而也可以使用更多或较少的褶皱或反向凹槽。所述反向凹槽的侧壁352是无褶皱的平面；其作用相当于实例二所述的加强筋250。本实例中所述内侧壁351也是平面的，然而所述内侧壁也可以是带有褶皱的曲面。
所述V型褶皱140和反向凹槽350共同增加了密封唇临近区域的环向周长；所述V型褶皱140可以减小密封唇的总体变形；而所述反向凹槽350可以起到牵拉密封唇134及其临近区域的作用。这种牵拉作用增强了整个密封壁135的轴向抗拉刚度。则插入器械时，所述密封唇134产生的轴向位移很小。因此所述密封膜330具有增大环向周长，减小总体变形和减小横向力，增大轴向抗拉刚度等作用。可以减小摩擦力，改善粘滑和提高密封可靠性。
图20-25详细描绘了本发明的第四个实施例密封膜430。所述密封膜430包括远端孔433，密封唇434，密封壁435和凸缘436。所述远端孔433由密封唇434形成。所述密封壁435一端连接密封唇434而另一端连接凸缘436的壁部分438。所述密封膜430具有近端面和远端面。定义所述密封唇434的轴线为158。定义垂直于轴线158的横平面159。
所述密封壁435包含多个近似U型褶皱440和多个反向凹槽450(或称空心筋450)。
所述U型褶皱440与密封唇434外切并横向向外延伸。所述U型褶皱440包括内褶皱壁441，外褶皱壁443以及连接所述内褶皱壁441和外褶皱壁443的褶皱侧壁442。所述内褶皱壁441与所述褶皱侧壁442相交形成交线445a，445b；所述外褶皱壁443与所述褶皱侧壁442相交形成交线446a，446b。所述交线445a(445b)和交线446a(446b)不是直线，而是包含波峰和波谷的波浪线。所述波浪线445a(445b)和446a(446b)的波浪是沿着背离轴线458的方向横向延伸的，称之为横向褶皱(或径向褶皱)。而U型褶皱440总体围绕密封唇434近似均匀的分布，称之切向褶皱(或环向褶皱)。所述U型褶皱440是横向褶皱和切向褶皱叠加而成的“多维褶皱”。
多个反向凹槽450从密封唇434横向向外延伸至壁部分438。所述反向凹槽450从所述褶皱440的远端面向近端面凹陷，从远端面的视角看，所述反向凹槽450是下凹的，而从近端面的视角看，所述反向凹槽450是从密封体上隆起的筋。所述反向凹槽450包含内侧壁451和侧壁452。所述内侧壁451和侧壁452相交形成交线455a，455b；所述侧壁452与所述外褶皱壁443相交形成交线456a，456b。所述内侧壁451，侧壁452的一端与 密封唇434相交而另一端与壁部分438相交。所述多个U型褶皱440和多个反向凹槽450共同组成了无缝隙的密封壁435。本实例中有8个U型褶皱440和4个反向凹槽450，然而也可以使用更多或较少的褶皱或反向凹槽。所述反向凹槽450的侧壁452是无褶皱的平面；其作用相当于实例二所述的加强筋250。本实例中所述内侧壁451也是平面的，然而所述内侧壁也可以是带有褶皱的曲面。
所述U型褶皱440和反向凹槽450共同增加了密封唇临近区域的环向周长；所述U型褶皱440可以减小密封唇的总体变形；而所述反向凹槽450可以起到牵拉密封唇434及其临近区域的作用。这种牵拉作用增强了整个密封壁435的轴向抗拉刚度。则插入器械时，所述密封唇434产生的轴向位移很小。因此所述密封膜430具有增大环向周长，减小总体变形和减小横向力，增大轴向抗拉刚度等作用。可以减小摩擦力，改善粘滑和提高密封可靠性。
本领域技术人员很容易想到，合理的圆角过渡可以避免应力集中或使得某些区域变形更容易。由于膜密封的尺寸较小，尤其是密封唇附近区域的尺寸更小，如此微小的尺寸，倒角不同，则膜密封的外形看起来差异较大。为了清晰的展示个元素之间的几何关系，本发明描述之实例，通常为去掉圆角之后的图形。
已经展示和描述了本发明的很多不同的实施方案和实例。本领域的一个普通技术人员，在不脱离本发明范围的前提下，通过适当修改能对所述方法和器械做出适应性改进。例如本发明中的实例中使用了美国专利US7789861中披露的保护片结构及其固定方式，然而也可以采用美国专利US7988671披露的保护片结构及其固定方式，某些应用情形下也可以不包含保护片结构。例如本实例中描述的近似U型槽和近似V型槽，不能被限制为其形状必须为U型或V型。例如本发明中多次提到所述反向凹槽从密封唇处开始横向向外延伸，所谓“横向向外延伸”不应被限制为其延伸轨迹为直线，所述横向向外延伸时的轨迹也可以是螺旋线，折线段，多段圆弧线等曲线。例如本发明的实例中详细描述了组成所述反向凹槽的各相交面的位置关系及其交线，也可以采用增加曲面形成多面拼接或者采用高次曲面的方式使其交线和凹槽外形看起来与实例有较大差异，但只要总体符合本发明的思想，仍然认为没有脱离本发明的范围。好几种修正方案已经被提到，对于本领域的技术人员来说，其他修正方案也是可以想到的。因此本发明的范围应该依照附加权利要求，同时不应被理解为由说明书及附图显示和记载的结构，材料或行为的具体内容所限定。

Claims (9)

  1. 一种含多维褶皱的穿刺器密封膜，所述密封膜包括近端开口和远端孔以及从远端孔延伸至近端开口的密封壁，所述密封壁具有近端面和远端面；所述远端孔由密封唇形成，用于容纳插入的器械并形成气密封；其特征在于，在密封唇临近区域，所述密封壁同时具有多个从密封唇横向向外延伸的横向褶皱和围绕密封唇均布的切向褶皱。
  2. 如权利要求1所述的密封膜，其特征在于，所述密封壁还包含从密封唇开始的横向向外延伸的实心筋。
  3. 如权利要求1所述的密封膜，其特征在于，所述密封壁还包含从密封唇开始的横向向外延伸的从密封壁远端面向近端面凹陷的开口朝向远端面的反向凹槽，从近端面的视角看所述反向凹槽是从近端面凸起的筋，且所述反向凹槽包含两个平面的无褶皱的侧壁。
  4. 如权利要求3所述的密封膜，其特征在于，所述切向褶皱的截面是U型的。
  5. 如权利要求3所述的密封膜，其特征在于，所述切向褶皱的截面是V型的。
  6. 如权利要求3所述的密封膜，其特征在于，包含4个所述反向凹槽。
  7. 如权利要求3所述的密封膜，其特征在于，所述密封唇是圆环形的或圆柱形的。
  8. 如权利要求3所述的密封膜，其特征在于，还包括与所述褶皱和所述筋同时相交的凸缘，以及从凸缘延伸至近端开口的包括多个横向褶皱的浮动部分。
  9. 一种穿刺器密封组件，其特征在于，包括如权利要求3-7中任一项所述的密封膜，所述密封组件还包含下固定环，上固定环，保护装置，上壳体和上盖；所述密封膜还包括与所述褶皱和所述筋同时相交的凸缘，以及从凸缘延伸至近端开口的包括至少一个横向褶皱的外部浮动部分；所述密封膜和保护装置被夹在上固定环和下固定环之间，所述密封膜的近端开口被夹在上壳体和上盖之间。
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