WO2018024101A1 - 改进的褶皱型穿刺器密封膜保护装置 - Google Patents

改进的褶皱型穿刺器密封膜保护装置 Download PDF

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Publication number
WO2018024101A1
WO2018024101A1 PCT/CN2017/093600 CN2017093600W WO2018024101A1 WO 2018024101 A1 WO2018024101 A1 WO 2018024101A1 CN 2017093600 W CN2017093600 W CN 2017093600W WO 2018024101 A1 WO2018024101 A1 WO 2018024101A1
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WO
WIPO (PCT)
Prior art keywords
pleat
sealing film
distal end
pleats
distal
Prior art date
Application number
PCT/CN2017/093600
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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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 WO2018024101A1 publication Critical patent/WO2018024101A1/zh
Priority to US16/249,953 priority Critical patent/US20190142461A1/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
    • A61B17/00234—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
    • 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
    • A61B17/3462—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
    • A61B17/34—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
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • 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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • 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
    • A61B2017/3419—Sealing means between cannula and body
    • 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

Definitions

  • the invention relates to a minimally invasive surgical instrument, in particular to a puncture seal protection device.
  • 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-diameter cannula assemblies (typically 5 mm) and two large-diameter cannula assemblies (typically 10-15 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.
  • the large frictional resistance is generally liable to cause damage to the sealing film, the sealing film is inverted, the operation comfort is poor, and even the casing assembly is not fixed firmly on the abdominal wall of the patient, which seriously affects the use of the puncturing device.
  • One of the simplest and most effective ways to reduce the frictional resistance is to reduce the wall thickness of the sealing film, however this inevitably results in the sealing film being easily torn or pierced by the inserted instrument.
  • US Pat. No. 5,342,315 discloses a petal sealing membrane protection device comprising at least two Petal-shaped protective sheet that is disconnected from each other.
  • the protection device is for preventing the external insertion device from perforating or tearing the sealing film, and at the same time reducing the frictional resistance between the instrument and the sealing film.
  • a wrinkle-containing integral sealing film protection device comprising an integral, seamless, frustoconical protective cover is disclosed in US Pat. No. 7,798,671, US Pat.
  • the pleats of the peaks and valleys; the protective cover prevents the external insertion device from damaging the sealing film and preventing the sealing film from inverting.
  • FIGS 1-6 detail the protective device 1260 and sealing film 1250 disclosed in US7988671.
  • the protective device 1260 is generally tubular in shape and includes a proximal end 1262 and a distal end 1264.
  • the protective device 1260 is shaped and sized to be mounted in the sealing film 1250 without interfering with it.
  • the proximal end 1262 includes a flange 1266 for internal insertion into the inner groove 1256 of the sealing membrane 1250, and the protective device 1260 moves or floats with the sealing membrane 1250.
  • the distal end 1264 is generally frustoconical and mates with the distal end 1258 of the sealing membrane 1250.
  • the truncated conical distal end 1264 includes a plurality of pleats 1268 that define a distal opening 1270. Cylindrical wall 1272 connects proximal end 1262 and distal end 1264.
  • the axis of the protection device 1260 is defined as 1261. 3 is a projection view of the guard 1260 from the distal end 1264 to the proximal end 1262 along the axis 1261.
  • the distal opening 1270 is defined by a complete annular wavy line 1265.
  • a cross section generally perpendicular to the axis 1261 intersects the distal end 1264, the intersection of which is a complete annular wavy line; or at least in the vicinity of the opening 1270 a cross section generally perpendicular to the axis 1261 Intersecting with all pleats 1268, the intersection line must be a complete annular wavy line; referred to herein as a planar wavy ring.
  • the distal end 1264 can be viewed as a myriad of complete planar wave rings stacked in the direction of the axis 1261. Typically, the circumference of any one of the planar wave rings is necessarily greater than the outer circumference of the designed maximum diameter instrument. When the large diameter instrument is externally inserted, all of the planar wave rings are relaxed to varying degrees, i.e., all of the pleats 1268 are fully relaxed.
  • the protection device 1260 has two major drawbacks. Referring to FIG. 5, the opening 1270 defined by the annular wavy line 1265 includes a plurality of voids that make the exposed region 1259 of the distal end 1258 larger. It should be understood by those skilled in the art that the exposed area 1259 is easily damaged when the external instrument is inserted; in particular, when the titanium clamp is inserted, the cutting edge of the titanium clamp is opened to form a U-shaped fork structure, the U The prongs are often automatically guided by the pleats 1268 to the exposed regions 1259, thereby increasing the risk of piercing the sealing film.
  • Figure 6 shows a schematic representation of the protection device 1260 and the sealing film 1250 when the instrument (electrocoagulation hook) is pulled outward.
  • the protective device 1260 and the sealing film 1250 are susceptible to application when certain instruments are applied, or when the instrument is pulled outward from an angle. Inverted. Also, US7987981 discloses that the protection device 1260 may be at risk of varus.
  • a protective device 1260 in which the proximal end 1262 is relatively rigid and the distal end 1264 is relatively soft is disclosed in US7988671.
  • the 1260 is composed of a multilayer film containing a plurality of layers and the distal end containing Fewer layers allow the distal end 1264 to be inverted.
  • the pleats 1268 have a strong property of enhancing the bending stiffness of the distal end 1264; when the distal end 1264 is outwardly dilated or inwardly inverted In most cases, it is easier to rotate about the intersection 1263 of the distal end 1264 with the cylindrical wall 1272, rather than bending at a location intermediate the distal end 1264. It will be understood by those skilled in the art that in the case disclosed in US7987981, when the distal end 1264 is inverted, that is, when the pleated wall 1267 constituting the distal pleat 1268 is rotated inwardly around the intersecting region 1263, The distal ends 1264 themselves interfere with each other.
  • the present invention provides an improved pleated seal protection device that effectively addresses one or more of the aforementioned deficiencies.
  • An object of the present invention is to provide a sealing film protecting device that minimizes a sealing film exposed outside the covering area of the protective device, and at the same time prevents the sealing film and the protective device from being caught after being inverted.
  • a trocar sealing membrane protector for minimally invasive surgery, the protective device comprising a proximal opening, a distal end and a central axis.
  • the distal end includes a plurality of pleats, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley.
  • the plurality of pleats are arranged in a dish around the central axis and define a distal aperture, the boundary of the distal aperture being formed by a wavy loop.
  • the undulating loop is completely on a cylindrical surface or completely on a conical surface.
  • the center of the center axis is the intersection of all the pleats of any cylindrical surface and the vicinity of the distal hole, and the intersection line is a complete wavy loop.
  • the proximal opening of the protective device further includes a boss and a cylindrical wall extending from the proximal end to the distal end. The pleats extend laterally outward from the distal aperture and intersect the cylindrical wall to form a triangular transition region.
  • a trocar seal film protector for minimally invasive surgery, the guard having a proximal opening, a distal end and a central axis.
  • the distal end includes a plurality of pleats, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley.
  • the plurality of pleats are arranged in a dish around the central axis and define a distal aperture, the boundary of the distal aperture being formed by a wavy loop.
  • the undulating loop is completely on a cylindrical surface.
  • the center of the center is the center of the circle and the intersection of all the pleats of the adjacent area of the distal hole is the complete wave. loop.
  • the proximal opening of the protective device further includes a boss and a cylindrical wall extending from the proximal end to the distal end, and a rib extending from the cylindrical wall and intersecting the pleat valley; and the pleat peak and The adjacent pleat walls are cantilevered and do not intersect the cylindrical wall.
  • a trocar seal film protector for minimally invasive surgery, the guard having a proximal opening, a distal end and a central axis.
  • the distal end includes a plurality of pleats, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley.
  • the plurality of pleats are arranged in a dish around the central axis and define a distal aperture, the boundary of the distal aperture being formed by a wavy loop.
  • the undulating loop is completely on a cylindrical surface.
  • the center of the center axis is the intersection of all the pleats of any cylindrical surface and the vicinity of the distal hole, and the intersection line is a complete wavy loop.
  • the proximal opening of the protective device also includes a securing flange that extends laterally outward from the distal opening and intersects the mounting flange. When the pleats extend laterally outward, their pleat depth gradually decreases.
  • a trocar seal film protector for minimally invasive surgery, the guard having a proximal opening, a distal end and a central axis.
  • the distal end includes a plurality of pleats, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley.
  • the plurality of pleats are arranged in a dish around the central axis and define a distal aperture, the boundary of the distal aperture being formed by a wavy loop.
  • the undulating loop is completely on a cylindrical surface.
  • the center of the center axis is the intersection of all the pleats of any cylindrical surface and the vicinity of the distal hole, and the intersection line is a complete wavy loop.
  • the pleat peaks or pleat valleys all or partially contain slits or kerfs in the vicinity of the distal aperture.
  • a trocar seal film protector for minimally invasive surgery, the guard having a proximal opening, a distal end and a central axis.
  • the distal end includes a plurality of pleats, each of the pleats comprising a pleat peak, a pleat valley, and a pleat wall extending from the pleat peak to the pleat valley.
  • the plurality of pleats are arranged in a dish around the central axis and define a distal aperture, the boundary of the distal aperture being formed by a wavy loop.
  • the undulating loop is completely on a cylindrical surface.
  • the center of the center axis is the intersection of all the pleats of any cylindrical surface and the vicinity of the distal hole, and the intersection line is a complete wavy loop.
  • the proximal opening includes a plurality of cantilevers and slots.
  • Another object of the present invention is to provide a trocar sealing film assembly comprising a sealing film and a sealing film protecting device, the protective device being shaped and sized to be mounted inside the sealing film Do not interfere with it.
  • the protective device may be embedded in the sealing film, or the protective device may be mounted on the seal by mechanical fixing or by bonding, for protecting the central sealing body of the sealing film from external insertion instruments. crack.
  • It is still another object of the present invention to provide a puncturing device assembly comprising the aforementioned sealing film assembly, an upper casing and an upper cover.
  • the sealing film assembly is mounted between the upper cover and the upper case.
  • Figure 1 is a perspective view of a prior art sealing film protection device
  • Figure 2 is a longitudinal sectional view of the sealing film protection device shown in Figure 1 of the prior art
  • Figure 3 is a bottom plan view of the sealing film protection device shown in Figure 1 of the prior art
  • Figure 4 is a longitudinal cross-sectional view of a prior art sealing film assembly including the sealing film protection device of Figure 1;
  • Figure 5 is a partial cross-sectional view taken along line 5-5 of the prior art assembly of Figure 4;
  • Figure 6 is a schematic view showing the simulation of the device of Figure 5 in the prior art
  • Figure 7 is a perspective, partial, cross-sectional view of the cannula assembly of the present invention.
  • Figure 8 is a top plan view of the sealing film assembly of the bushing assembly of Figure 2;
  • Figure 9 is a longitudinal cross-sectional view of the sealing film assembly of Figure 8.
  • Figure 10 is a perspective view of the sealing film protection device shown in Figure 8.
  • FIG 11 is a reverse perspective view of the sealing film protection device shown in Figure 10;
  • Figure 12 is a cross-sectional view taken along line 12-12 of the sealing film protection device shown in Figure 10;
  • Figure 13 is a cross-sectional view taken along line 13-13 of the sealing film protection device shown in Figure 10;
  • Figure 14 is a perspective view of a sealing film protection device according to a second embodiment of the present invention.
  • FIG 15 is a reverse perspective view of the sealing film protection device shown in Figure 14;
  • Figure 16 is a cross-sectional view taken along the line 16-16 of the sealing film protection device shown in Figure 14;
  • Figure 17 is a cross-sectional view taken along line 17-17 of the sealing film protection device shown in Figure 14;
  • Figure 18 is a perspective view of a sealing film protection device according to a third embodiment of the present invention.
  • Figure 19 is a reverse perspective view of the sealing film protection device shown in Figure 18;
  • Figure 20 is a cross-sectional view taken along line 20-20 of the sealing film protection device shown in Figure 19;
  • Figure 21 is a sectional view taken along line 21-21 of the sealing film protection device shown in Figure 19;
  • Figure 22 is an exploded perspective view of a sealing film assembly including a third example protective device
  • Figure 23 is an assembled view of the sealing film assembly of Figure 22;
  • Figure 24 is a simulated deformation view of the assembly of Figure 23 when a large diameter instrument is inserted;
  • Figure 25 is a longitudinal cross-sectional view of the assembly of Figure 24;
  • Figure 26 is a perspective view of a sealing film protecting device of a fourth embodiment of the present invention.
  • Figure 27 is an enlarged plan view showing a partial area of the center hole of the protection device of Figure 26;
  • Figure 28 is a cross-sectional view taken along line 28-28 of the sealing film protection device shown in Figure 26;
  • Figure 29 is a perspective view of a sealing film protection device according to a fifth embodiment of the present invention.
  • Figure 30 is a top plan view of the protection device of Figure 29;
  • Figure 31 is a sectional view taken along line 31-31 of the sealing film protection device shown in Figure 30;
  • FIG. 7 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. 7 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. 7 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 to the inner ring 116 of the upper cover 110 Between the inner ring 196 of the upper housing 190.
  • 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 sealing film 130 and a protection device 140 that is sized and shaped to be mounted inside the sealing film 130 without interfering with the sealing film 130.
  • the protective device 140 moves or floats with the sealing film 130 for protecting the central sealing wall 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 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 floating portion 137 includes one or more radial (lateral) pleats such that the entire sealing membrane assembly 180 can move or float within the assembly 200.
  • the flange 136 includes a cylindrical wall 139 and an inner groove 138 for mounting the protective device 140.
  • FIGS. 10-13 depict the structure and composition of the protective device 140 in more detail.
  • the guard device 140 has a central axis 141 that includes a proximal end 142 and a distal end 144 and a cylindrical wall 146 that extends from the proximal end to the distal end.
  • the proximal end 142 includes a boss 148 that is shaped and dimensioned to match the cylindrical wall 139 and the inner groove 138 of the sealing membrane, as described above, such that A protective device is embedded in the sealing film 130.
  • the distal end 144 is generally dish-shaped and sized to match the aforementioned sealing wall 135.
  • the distal end 144 includes a plurality of pleats 150 that are generally dished about the axis 141 and define a distal aperture 152. More specifically, the distal aperture 152 is defined by a complete annular wavy line 153. And the annular wavy line 153 is formed in such a manner that its annular wave is substantially on a cylindrical surface.
  • the area of 152 is referred to as the adjacent area of the distal hole.
  • An arbitrary cylindrical surface is intersected with the pleats with the axis 141 as an axis, and the intersection line is a complete annular wavy line; or at least the axis 141 is the axis of the arbitrary cylindrical surface intersecting the pleats in the vicinity of the distal hole The intersection is a complete circular wavy line.
  • Each of the pleats 150 includes a pleat wall 157 that extends between the pleat peaks 156 and the pleat valleys 158.
  • the pleats 150 extend laterally outward from the annular wavy line 153 and intersect the cylindrical wall 146 to form a triangular transition region 154. And when the pleats 150 extend laterally outward, the depth of the pleats remains substantially unchanged; the depth of the pleat walls can be obtained by measuring the distance between the pleat peaks and the pleat valleys along the direction of the axis 141.
  • a transverse plane 161 is defined that is generally perpendicular to the axis 141, defining an angle ⁇ between the pleat peak 156 and the transverse plane 161, defining an angle ⁇ between the pleat valley 158 and the transverse plane 161.
  • the protection device 140 of the present example projects from the proximal end to the distal end in the direction of the axis 141, and the distal end 152 defined by the pleats 150 is a circular ring.
  • the use of the protective device 140 can greatly reduce the exposed area of the sealing film, even if the central portion of the sealing film is barely exposed outside the coverage of the protective device.
  • the pleats 150 are generally dish-shaped, that is, the angle between the pleat peaks (pleat valleys) relative to the transverse plane 161 is small or zero; when the instrument is inserted, the cylindrical wave ring is fully relaxed.
  • the pleat wall 150 is rotated outwardly about the transition zone 154 to a suitable size to accommodate the inserted instrument; when the instrument is withdrawn, in some cases the sealing membrane and the protective device are inverted, when the diameter of the cylindrical wall 146 Sufficiently large, when sufficient inward space is reserved, only the inversion of the instantaneous sealing film and the protective device bending accumulation causes a surge in resistance.
  • the pleated wall 150 is rotated inwardly around the transition zone 154 to the appropriate extent. size.
  • the sealing film and the protection device do not interfere with each other after the inversion, and the bending accumulation and the winding of the protection device and the sealing film can be alleviated, thereby Reduce the frictional resistance after varus.
  • the inner diameter of the cylindrical wall 139 is usually 16-20 mm, and the inner diameter of the through hole defined by the annular wave line 153 is usually 4-6 mm, and when the ratio is ⁇ 30° or ⁇ 30°, the protection device is inside. It is easy to cause self-interference when turning over.
  • the protective device has a tendency to reduce wrinkle convergence only when the inversion moment occurs, and when the instrument is continuously pulled out, the The pleated wall 150 is inwardly rotated around the transition zone 154 to a suitable size. Usually take 0 ° ⁇ ⁇ ⁇ 15 °, 0 ° ⁇ ⁇ ⁇ 15 °.
  • FIGS 14-17 detail the structure and composition of a second embodiment of the protection device 240 of the present invention.
  • the guard device 240 has a central axis 241 that includes a proximal end 242 and a distal end 244 and a cylindrical wall 246 that extends from the proximal end to the distal end.
  • the proximal end 242 includes a boss 248, as described above, the cylindrical wall 246 and The boss 248 is shaped and sized to match the cylindrical wall 139 and the inner groove 138 of the sealing film such that the protective device is embedded in the sealing film 130.
  • the distal end 244 is generally dish-shaped and sized to match the aforementioned sealing wall 135.
  • the distal end 244 includes a plurality of pleats 250 that are generally dished about the axis 241 and define a distal aperture 252. More specifically, the distal aperture 252 is defined by a complete annular wavy line 253.
  • the annular wave line 253 is formed in such a manner that its annular wave is substantially on a cylindrical surface. However, an arbitrary cylindrical surface is intersected with the pleats with the axis 241 as an axis, and the intersection line is a complete annular wavy line; or at least the axis 241 is the axis of the pleat in the vicinity of the arbitrary cylindrical surface and the distal hole 252.
  • intersection is a complete circular wavy line. It is referred to herein as a cylindrical wavy ring to distinguish it from a planar annular wavy ring as described in the background.
  • the distal end 244 can be viewed as an infinite number of complete cylindrical wave rings of increasing diameter.
  • Each of the pleats 250 includes a pleat wall 257 that extends between the pleat peaks 256 and the pleat valleys 258.
  • the pleats 250 extend laterally outward from the annular wavy line 253 and the pleats 250 portion intersects the cylindrical wall 246.
  • a plurality of cutting grooves 254 are included between the pleats 250 and the cylindrical wall 246, the plurality of cutting grooves 254 slitting the pleats 250 and the cylindrical walls 246, thereby forming a plurality of ribs 256 to form the pleats 250 and the cylinder Walls 246 are joined together.
  • the pleat peaks 256 and pleat walls 257 are severed by 12 cut slots 254 so as not to intersect the cylindrical wall 246, and the pleat valleys 258 pass through the 12 ribs 256 and the cylindrical wall 246. connection. That is, the pleat peaks 256 of the pleats 250 and most of the pleat walls 257 are in a suspended state. And when the pleats 250 extend laterally outward, the depth of the pleats gradually increases; the depth of the pleat walls can be obtained by measuring the distance between the pleat peaks and the pleat valleys along the direction of the axis 241.
  • the main difference between the second embodiment and the first embodiment is that when the pleats 250 of the second embodiment extend laterally outward, only the pleat valley 258 and the cylindrical wall 246 extend to intersect, and the pleats 150 of the first embodiment are laterally oriented. When extended outward, its pleat peaks and pleat valleys simultaneously intersect the cylindrical wall 146. As described above, when the pleats are relaxed to the outside or inside, the pleats are rotationally relaxed around the transition region of the pleats and the cylindrical wall. However, in the first embodiment, the pleat peaks and the pleat valleys rotate in a different force arm, thus adding an additional deformation force. It will be understood by those skilled in the art that the pleats 250 described in the second embodiment are rotationally relaxed around the intersection of their pleat valleys 258 and ribs 256, and their rotational force arms are substantially equal, thereby minimizing additional deformation forces.
  • the protection device 340 has a central axis 341 that includes a proximal end 342 and a distal end 344.
  • the proximal end 342 includes a flange 348 and a bore 349 that is substantially uniform and over the flange 348.
  • the distal end 344 includes a plurality of pleats 350, and the plurality of pleats 350 are generally arranged in a dish around the axis 341.
  • a distal aperture 352 is defined. This example contains 16 of the pleats 350. More specifically, the distal aperture 352 is defined by a complete annular wavy line 353. And the annular wavy line 353 is formed in such a manner that its annular wave is substantially on a cylindrical surface. It should be understood by those skilled in the art that since the protection device has a small wrinkle depth and usually has a wrinkle depth of less than 2 mm, the annular wave line 353 can be formed in such a manner that its circumferential wave is completely on a conical surface.
  • annular wavy line 353 must be completely on a cylindrical surface; however, an arbitrary cylindrical surface is intersected with the pleats with the axis 341 as an axis, and the intersection line is a complete annular wavy line; or at least the axis 341
  • An arbitrary cylindrical surface is formed for the axis to intersect the pleats in the vicinity of the distal hole 353, and the intersection is a complete annular wavy line. It is referred to herein as a cylindrical wavy ring to distinguish it from a planar annular wavy ring as described in the background.
  • the distal end 344 can be viewed as an infinite number of complete cylindrical wave rings of increasing diameter.
  • Each of the pleats 350 includes a pleat wall 357 that extends between the pleat peaks 356 and the pleat valleys 358.
  • the pleats 350 extend laterally outward from the annular wavy line 353 and intersect the flange 348. And when the pleats 150 extend laterally outward, the depth of the pleats gradually decreases; the depth of the pleat walls can be obtained by measuring the distance between the pleat peaks and the pleat valleys along the direction of the axis 141.
  • the rate at which the pleat depth is reduced can be determined by theoretical calculations and simple tests such that when the large diameter instrument is inserted, the rotational force arms of the pleats as a whole are relaxed.
  • the sealing film assembly 380 further includes a lower fixing ring 320, an upper fixing ring 370, and a sealing film 330.
  • the sealing film 330 includes a proximal opening 332 and a distal opening 333; the distal opening 333 is defined by a sealing lip 334; the central sealing wall 335 extends from the sealing lip 334 to the flange 336; the outer floating portion 337 is from the flange 336 extends to the proximal end 332.
  • the sealing film 330 and the protection device 340 are sandwiched between the lower fixing ring 320 and the upper fixing ring 370.
  • the post 321 of the lower retaining ring 320 is aligned with the corresponding aperture in the other components of the assembly 380.
  • the post 321 is interference fit with the aperture 371 of the upper retaining ring 370 such that the entire sealing membrane assembly 380 is in a compressed state.
  • the protective device 360 serves to protect the central sealing body 335 of the sealing film 130 from perforations or tears caused by the sharp edges of the inserted surgical instrument.
  • the protection device 340 is made of a semi-rigid material; or is made of a rigid material but is semi-rigid due to its thin wall thickness; and the sealing film 330 is usually made of an elastic material such as silica gel, natural rubber or isoprene rubber. to make.
  • the sealing membrane lip 334 expands to a suitable sealing lip 334a to accommodate the inserted instrument, and all of the pleats of the protective device 340 are simultaneously relaxed to a sufficient size to accommodate the inserted instrument.
  • the protective device 340 since the protective device 340 is semi-rigid, its wrinkles are usually not fully relaxed; that is, after relaxation The guard 340 still has a small annular wave 353a. If the annular wave 353a of the protective device 340 is close to the sealing lip 334a after relaxation, it is easy to cause air leakage or unreliable sealing; and if the annular wave 353a is far enough away from the sealing lip 334a to ensure its sealing reliability Inevitably, more sealing walls of the sealing film 330 are exposed, thereby increasing the risk of being pierced or torn, and increasing the true contact area of the device and the sealing film to a certain extent to increase the frictional resistance.
  • Figures 26-28 detail the structure and composition of a fourth embodiment of the protection device 440 of the present invention.
  • the numerical designations of the geometrical structures are the same as the corresponding numerical designations of Figs. 18-21, and the representation structures of the same numerical reference numerals are substantially identical.
  • the guard 440 has a central axis 341 that includes a proximal end 342 and a distal end 344.
  • the proximal end 342 includes a flange 348 and a bore 349 that is substantially uniform and over the flange 348.
  • the distal end 344 includes a plurality of pleats 350 that are generally dished about the axis 341 and define a distal aperture 452.
  • the distal aperture 452 is defined by an annular wavy line 453, and the annular wavy line 453 is formed in such a manner that its annular wave is generally on a cylindrical surface.
  • Each of the pleats 350 includes a pleat wall 357 that extends between the pleat peaks 356 and the pleat valleys 358. The pleats 350 extend laterally outward from the annular wavy line 353 and intersect the flange 348.
  • the protective device 440 is substantially similar in shape and configuration to the protective device 340, except that the distal aperture 452 of the protective device 440 is not defined by a complete annular wavy line 453.
  • the guard 440 is not completely seamless in the vicinity of the distal aperture 452.
  • D i is defined as the design maximum diameter surgical instrument through the protection device
  • the axis 341 as an axis as the cylindrical diameter of D i
  • the distal end 344 intersect the line of intersection from the distal aperture
  • the area of 452 is referred to as the adjacent area of the via.
  • the pleat peaks 356 are broken by the slots 459 in the vicinity of the distal aperture 452.
  • the groove 459 can be directly injection molded together with the protection device 440, and the width of the groove is as small as possible; the groove 459 can also be formed by secondary processing, for example, directly cutting on the basis of the protection device 340, the groove The width of 459 is close to zero.
  • all of the pleat peaks comprise broken grooves; however, the pleat peaks and pleat valleys may be simultaneously grooved, or a portion of the pleat valleys may be grooved; or a portion of the pleat peaks may be opened. groove.
  • the width of the groove 459 is much smaller than the width of the working edge of the inserted titanium clamp, and since the protection device comprises a plurality of pleats, the working edge of the titanium clamp first contacts the pleats of the protective device and presses to force the pleats to partially relax; at this time, the grooves 459 generally do not increase, but material overlap occurs, and the titanium clip is still prevented.
  • the working edge of the pliers contacts the sealing wall covered by the guard 440.
  • the groove 459 acts to reduce the annular wave of the adjacent region of the through hole of the protection device as described above, and the design can expose the sealing wall area of the protection device. Fewer, thereby reducing the probability of damage to the sealing film and to some extent reducing the overall tensile tension and the resulting frictional resistance of the instrument moving in the sealing film. Additionally, since the guard 440 is semi-rigid, if the adjacent region of the distal aperture 452 is completely seamless, the circumference of the annular wavy line 453 must be greater than the peripheral perimeter of the largest diameter instrument that is designed to be inserted.
  • the circumferential circumference of the annular wave is not necessarily greater than the peripheral perimeter of the largest diameter instrument that is designed to be inserted. It is thus possible to reduce the size of the wrinkles or reduce the number of wrinkles, thereby simplifying the mold and providing processing efficiency.
  • the guard device 540 has a central axis 541 that includes a proximal end 542 and a distal end 544.
  • the proximal end 542 includes a plurality of cantilevers 546 and a plurality of indentations 548.
  • the distal end 544 includes a plurality of pleats 550 that are generally dished about the axis 541 and define a distal aperture 552. This example contains 16 of the pleats 550. More specifically, the distal aperture 552 is defined by a complete annular wavy line 553.
  • the wave peak of the annular wavy line 553 is at a greater distance from the axis 541 than the wave valley relative to the axis 541, and the annular wavy line 553 is formed in such a manner that its annular wave is generally on a conical surface.
  • An arbitrary cylindrical surface is intersected with the pleats with the axis 541 as an axis, and the intersection line is a complete annular wavy line; or at least the axis 541 is used as an axis to intersect the pleats in the vicinity of the distal hole 552.
  • the intersection is a complete circular wavy line. It is referred to herein as a cylindrical wavy ring to distinguish it from a planar annular wavy ring as described in the background.
  • the distal end 544 can be viewed as a myriad of complete cylindrical wavy rings of increasing diameter.
  • Each of the pleats 550 includes a pleat wall 557 that extends between the pleat peaks 556 and the pleat valleys 558.
  • the pleats 550 are laterally extended from the annular wavy line 553, and the pleats are gradually reduced in depth as the pleats 550 extend laterally outward; the pleat walls may measure the pleat peaks along the axis 541 The distance between the fold valleys is obtained.
  • the protective device 540 can be secured to the sealing film by bonding, mechanically securing or welding or otherwise.

Abstract

一种改进的褶皱型穿刺器密封膜保护装置（140，240，340，440，540），保护装置（140，240，340，440，540）包含近端（142，242，342，542）开口，远端（144，244，344，544）和中心轴线（141,241,341,541）。远端（144，244，344，544）包含多个褶皱（150，250，350，550），每个褶皱（150，250，350，550）包含褶皱峰（156，256，356，556），褶皱谷（158，258，358，558）以及从褶皱峰（156，256，356，556）延伸至褶皱谷（158，258，358，558）的褶皱壁（157，257，357，557）。多个褶皱（150，250，350，550）围绕中心轴线（141，241，341，541）呈碟形排列并限定出远端孔（152，252，352，452，552），远端孔（152，252，352，452，552）的边界由波浪环线（153，253，353，453，553）形成。波浪环线（153，253，353，453，553）完全处于一个圆柱面上或者完全处于一个圆锥面上。以中心轴线（141，241，341，541）为圆心作任意圆柱面与远端孔（152，252，352，452，552）临近区域的所有褶皱（150，250，350，550）相交其交线是完整的波浪环线（153，253，353，453，553）。保护装置（140，240，340，440，540）的近端（142，242，342，542）开口还包括凸台（148，248）和从近端（142，242，342，542）延伸至远端（144，244，344，544）的圆柱壁（146，246）。密封膜（130，330）及保护装置（140，240，340，440，540）内翻后不会出现保护装置（140，240，340，440，540）自身相互干涉的情况，可减轻保护装置（140，240，340，440，540）与密封膜（130，330）的弯曲堆积和缠绕，从而减小内翻后的摩擦阻力。

Description

改进的褶皱型穿刺器密封膜保护装置 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保护装置。
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10～15mm)。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。
以12mm规格穿刺器(通常内径为12.8～12.9mm)的临床应用为例：应用5mm直径器械时，近似认为仅密封唇(即形成密封膜中心孔的局部材料)伸长变形产生的环箍紧力确保对于插入器械的可靠密封。应用大直径器械时(例如12mm吻合器或10mm钛夹钳)，密封唇及其临近区域均胀大到合适尺寸并包裹在器械外表面，这导致密封膜与器械间的摩擦阻力较大。所述较大摩擦阻力通常容易造成密封膜损坏，密封膜内翻，操作舒适性差，甚至导致套管组件在患者腹壁上固定不牢靠等缺陷，严重影响穿刺器的使用。减小所述摩擦阻力，最简单有效的方法之一是减小所述密封膜的壁厚，然而这必然导致密封膜容易被插入的器械撕裂或刺穿。
US5342315披露了一种花瓣式密封膜保护装置，所述密封膜保护装置包含至少两个 相互断开的花瓣形的保护片。所述保护装置用于防止外部插入器械对密封膜产生穿孔或撕裂，并同时可减小器械与密封膜之间的摩擦阻力。
US7988671，US8257317，US8597251中披露了一种含褶皱的整体式密封膜保护装置，所述整体式密封膜保护装置包含整体的无缝隙的截圆锥形的保护罩；所述保护罩是由多个具有峰和谷的褶皱组成的；所述保护罩既可防止外部插入器械损坏密封膜又可防止密封膜内翻。
图1-6详细的描绘了US7988671披露的保护装置1260及密封膜1250。所述保护装置1260整体呈管状，包含近端1262和远端1264。所述保护装置1260的形状和尺寸设计成可安装在密封膜1250中而不与之产生干涉。所述近端1262包含凸缘1266用于内嵌入所述密封膜1250的内凹槽1256中，所述保护装置1260随着密封膜1250移动或浮动。所述远端1264整体呈截圆锥形，并与密封膜1250的远端1258匹配。所述截圆锥形的远端1264包含多个褶皱1268，所述多个褶皱1268限定出远端开口1270。圆柱壁1272连接近端1262和远端1264。
尽管US7988671中披露了多个实例，但这些实例有两个共同特征：其一是所述褶皱是整体无缝隙的，其二是褶皱整体呈截圆锥形。定义所述保护装置1260的轴线为1261。图3是所述保护装置1260沿着所述轴线1261从远端1264向近端1262的投影视图。所述远端开口1270由完整的环形波浪线1265所限定。作大致垂直于所述轴线1261的横剖面与所述远端1264相交，其交线是完整的环形波浪线；或者至少在所述开口1270的临近区域作大致垂直于所述轴线1261的横剖面与所有褶皱1268均相交，其交线必然是完整的环形波浪线；在此称其为平面波浪环。所述远端1264可看成无数个完整的平面波浪环沿着轴线1261方向堆砌而成。通常任意一个所述平面波浪环的周长必然大于设计的插入最大直径器械的外圆周长。当外部插入大直径器械时，所有平面波浪环不同程度的舒张，即所有所述褶皱1268整体舒张。
所述保护装置1260有两个主要缺陷。参考图5，所述环形波浪线1265限定的所述开口1270包含多个空隙，这使得所述远端1258的暴露区1259较大。本领域的技术人员应该可以理解，插入外部器械时容易损坏所述暴露区1259；特别是插入钛夹钳时，钛夹钳工作时其刃口张开，形成一个U型叉结构，所述U型叉往往被所述褶皱1268自动导向至所述暴露区1259，从而增大了刺穿密封膜的风险。图6展示了向外拔出器械(电凝钩)时，保护装置1260及密封膜1250的模拟示意图。本领域的技术人员应该可以理解，在应用某些器械，或者从某个角度向外拔出器械时，所述保护装置1260和密封膜1250容易发 生内翻。而US7988671中也披露了保护装置1260可能存在内翻的风险。US7988671中披露了一种所述近端1262较硬而远端1264较软的保护装置1260，例如所述1260由多层薄膜组成，所述近端1262含有较多的层而所述远端含有较少的层，从而允许所述远端1264内翻。研究表明，由于所述远端1264包含多个褶皱1268，而所述褶皱1268具有较强的增强所述远端1264的抗弯曲刚度的性质；所述远端1264向外舒张或向内翻转时，大多数情况下更容易围绕所述远端1264与所述圆柱壁1272相交区域1263旋转，而不是在所述远端1264中间的某个部位弯曲。本领域的技术人员应该可以理解，US7988671中披露的案例中，其所述远端1264内翻时，即组成所述远端的褶皱1268的褶皱壁1267围绕所述相交区域1263向内侧旋转时，所述远端1264自身相互干涉。US7988671中没有任何关于所述远端1264内翻时自身干涉的披露。另外，某些情况下所述远端1264自身产生弯曲进而内翻，这又容易导致密封膜远端1258和所述弯曲的远端1264相互堆积或缠绕，导致堵死或者摩擦阻力异常增大。
本发明提出改进的褶皱型密封保护装置可有效解决前述一个或多个缺陷。
发明内容
本发明的一个目的是提供一种密封膜保护装置，使得裸露在所述保护装置覆盖区域之外的密封膜最小化，同时还可防止密封膜及保护装置内翻后卡死。
在本发明的一个方面，一种用于微创手术的穿刺器密封膜保护装置，所述保护装置包含近端开口，远端和中心轴线。所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁。所述多个褶皱围绕中心轴线呈碟形排列并限定出远端孔，所述远端孔的边界由波浪环线形成。所述波浪形环线完全处于一个圆柱面上或者完全处于一个圆锥面上。以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪环线。所述保护装置的近端开口还包括凸台和从近端延伸至远端的圆柱壁。所述褶皱从远端孔开始横向向外延伸并与所述圆柱壁相交形成三角形过渡区域。
在本发明的另一个方面，一种用于微创手术的穿刺器密封膜保护装置，所述保护装置具有近端开口，远端和中心轴线。所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁。所述多个褶皱围绕中心轴线呈碟形排列并限定出远端孔，所述远端孔的边界由波浪环线形成。所述波浪形环线完全处于一个圆柱面上。以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪 环线。所述保护装置的近端开口还包括凸台和从近端延伸至远端的圆柱壁，以及从所述圆柱壁延伸出的并与所述褶皱谷相交的肋；而所述褶皱峰及其临近的褶皱壁呈悬臂状，不与所述圆柱壁相交。
在本发明的又一个方面，一种用于微创手术的穿刺器密封膜保护装置，所述保护装置具有近端开口，远端和中心轴线。所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁。所述多个褶皱围绕中心轴线呈碟形排列并限定出远端孔，所述远端孔的边界由波浪环线形成。所述波浪形环线完全处于一个圆柱面上。以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪环线。所述保护装置的近端开口还包括固定法兰，所述褶皱从远端孔开始横向向外延伸并与固定法兰相交。所述褶皱横向向外延伸时，其褶皱深度逐渐减小。
在本发明的又一个方面，一种用于微创手术的穿刺器密封膜保护装置，所述保护装置具有近端开口，远端和中心轴线。所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁。所述多个褶皱围绕中心轴线呈碟形排列并限定出远端孔，所述远端孔的边界由波浪环线形成。所述波浪形环线完全处于一个圆柱面上。以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪环线。在远端孔临近区域内，所述褶皱峰或褶皱谷全部或部分包含切口或切槽。
在本发明的又一个方面，一种用于微创手术的穿刺器密封膜保护装置，所述保护装置具有近端开口，远端和中心轴线。所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁。所述多个褶皱围绕中心轴线呈碟形排列并限定出远端孔，所述远端孔的边界由波浪环线形成。所述波浪形环线完全处于一个圆柱面上。以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪环线。所述近端开口包含多个悬臂和切槽。
本发明的另一个目的是提供一种穿刺器密封膜组件，所述密封膜组件包含密封膜和密封膜保护装置，所述保护装置的外形和尺寸设计成可以安装在所述密封膜的内部而不与之产生干涉。所述保护装置可以内嵌在密封膜中，或者通过机械固定或者通过粘接的方法将所述保护装置安装在密封上，用于保护密封膜的中心密封体免受外部插入器械刺穿或撕裂。
本发明的又一个目的是提供一种穿刺器密封组件，所述密封组件包括前述密封膜组件，上壳和上盖。所述密封膜组件被安装在上盖和上壳之间。
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是现有技术的密封膜保护装置的立体图；
图2是现有技术图1所示的密封膜保护装置的纵向剖面图；
图3是现有技术图1所示的密封膜保护装置的底部投影视图；
图4是现有技术包含图1所示密封膜保护装置的密封膜组件的纵向剖视图；
图5是现有技术图4所示组件的5-5局部剖视图；
图6是现有技术图5所述组件中拔出器械时的模拟示意图；
图7是本发明套管组件的立体的局部的剖视图；
图8是图2所述套管组件中的密封膜组件的顶部投影图；
图9是图8所示密封膜组件的纵向剖视；
图10是图8所示密封膜保护装置的立体图；
图11是图10所示密封膜保护装置的反向立体图；
图12是图10所示密封膜保护装置的12-12剖视图；
图13是图10所示密封膜保护装置的13-13剖视图；
图14是本发明第二个实施例的密封膜保护装置的立体图；
图15是图14所示密封膜保护装置的反向立体图；
图16是图14所示密封膜保护装置的16-16剖视图；
图17是图14所示密封膜保护装置的17-17剖视图；
图18是本发明第三个实施例的密封膜保护装置的立体图；
图19是图18所示密封膜保护装置的反向立体图；
图20是图19所示密封膜保护装置的20-20剖视图；
图21是图19所示密封膜保护装置的21-21剖视图；
图22是包含第三实例保护装置的密封膜组件的立体分解视图；
图23是图22所述密封膜组件的组装图；
图24是图23所示组件中插入大直径器械时的模拟变形图；
图25是图24所述组件的纵向剖视图；
图26是本发明第四个实施例的密封膜保护装置的立体图；
图27是图26所述保护装置中心孔局部区域放大视图；
图28是图26所示密封膜保护装置的28-28剖视图；
图29是本发明第五个实施例的密封膜保护装置的立体图；
图30是图29所述保护装置顶部投影视图；
图31是图30所示密封膜保护装置的31-31剖视图；
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7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7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7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8-9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包含密封膜130和保护装置140，所述保护装置140的尺寸和外形设计成可以安装在所述密封膜130的内侧而不与所述密封膜130产生干涉。所述保护装置140随密封膜130一起移动或浮动，用于保护所述密封膜130的中心密封壁，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包含近端开口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中移动或浮动。所述凸缘136包含圆柱壁139和内凹槽138，所述凸缘136用于安装保护装置140。
图10-13更详细的描绘了所述保护装置140的结构和组成。所述保护装置140具有中心轴线141，所述保护装置140包含近端142和远端144以及由近端延伸至远端的圆柱壁146。所述近端142包含凸台148，如前文所述，所述圆柱壁146和凸台148的形状和尺寸设计成与密封膜的所述圆柱壁139和内凹槽138相匹配，使得所述保护装置内嵌在所述密封膜130中。
所述远端144整体呈碟形且其尺寸与前述密封壁135相匹配。所述远端144包含多个褶皱150，多个所述褶皱150围绕轴线141整体呈碟形排列并限定出远端孔152。更具体的，所述远端孔152由完整的环形波浪线153所限定。且所述环形波浪线153的形成方式为其环形波浪大体处于一个圆柱面上。为方便量化，定义当Di为设计通过保护装置的手术器械的最大直径时，以轴线141为轴心作直径为Di的圆柱与所述远端144相交，从其交线到远端孔152的区域称为远端孔临近区域。以轴线141为轴心作任意圆柱面与所述褶皱相交，其交线是完整的环形波浪线；或者至少以轴线141为轴心作任意圆柱面与所述远端孔临近区域内的褶皱相交，其交线是完整的环形波浪线。在此称其为圆柱形波浪环 以区别于背景技术中所述的平面环形波浪环。所述远端144可以看成无数个直径逐渐增大的完整的圆柱形波浪环堆砌而成。通常，任意圆柱形波浪环的周长L1大于设计通过的最大直径器械的外周周长。例如设计通过的最大器械的半径为R1，则L1＞2*π*R1(其中π＝3.14)。本实例包含12个褶皱，然而也可以采用更多或较少的褶皱。
每个所述褶皱150均包括在褶皱峰156和褶皱谷158之间延伸的褶皱壁157。所述褶皱150从环形波浪线153开始横向向外延伸并与所述圆柱壁146延伸相交形成三角形过渡区域154。且所述褶皱150横向向外延伸时，所述褶皱的深度基本保持不变；所述褶皱壁的深度可以沿着轴线141方向测量褶皱峰和褶皱谷之间的距离得到。定义大致垂直于所述轴线141的横平面161，定义所述褶皱峰156与所述横平面161的夹角为α，定义褶皱谷158与横平面161的夹角为β。
结合图8，本实例所述的保护装置140，沿着轴线141方向从近端向远端投影，所述褶皱150限定出的远端孔152为圆环。相对于背景技术中披露的保护装置，使用保护装置140可较大程度的减小密封膜的暴露区域，甚至于密封膜中心区域几乎没有暴露在保护装置覆盖范围以外。结合图9-13，所述褶皱150整体呈碟形，即所述褶皱峰(褶皱谷)相对于横平面161的夹角很小或为零；插入器械时，所述圆柱形波浪环整体舒张，所述褶皱壁150围绕过渡区154向外旋转舒张至合适尺寸以容纳插入的器械；当拔出器械时，某些情况下导致密封膜及保护装置内翻，当所述圆柱壁146的直径足够大，预留足够的内翻空间时，仅内翻的瞬间密封膜及保护装置弯曲堆积导致阻力激增，继续往外拔出器械时，所述褶皱壁150围绕过渡区154向内旋转舒张至合适尺寸。相对于背景技术中披露的保护装置，使用所述保护装置140，密封膜及保护装置内翻后不会出现保护装置自身相互干涉的情况，可减轻保护装置与密封膜的弯曲堆积和缠绕，从而减小内翻后的摩擦阻力。
所述褶皱150整体呈碟形排列且α＝β＝0°，然而不能被理解为所述α角或β必须为零。所述圆柱壁139的内径通常为16～20mm，而所述环形波浪线153限定出的通孔内径通常为4～6mm，则当α≥30°或β≥30°时，所述保护装置内翻时容易产生自身干涉。本领域技术人员应该可以理解，当褶皱峰和褶皱谷相对与其旋转支点具有较小角度时，仅内翻的瞬间所述保护装置存在褶皱收敛减小的趋势，继续往外拔出器械时，所述褶皱壁150围绕过渡区154向内旋转舒张至合适尺寸。通常取0°≤α≤15°，0°≤β≤15°。
图14-17详细的描绘了本发明的第二个实施例保护装置240的结构和组成。所述保护装置240具有中心轴线241，所述保护装置240包含近端242和远端244以及由近端延伸至远端的圆柱壁246。所述近端242包含凸台248，如前文所述，所述圆柱壁246和 凸台248的形状和尺寸设计成与密封膜的所述圆柱壁139和内凹槽138相匹配，使得所述保护装置内嵌在所述密封膜130中。
所述远端244整体呈碟形且其尺寸与前述密封壁135相匹配。所述远端244包含多个褶皱250，多个所述褶皱250围绕轴线241整体呈碟形排列并限定出远端孔252。更具体的，所述远端孔252由完整的环形波浪线253所限定。且所述环形波浪线253的形成方式为其环形波浪大体处于一个圆柱面上。但以轴线241为轴心作任意圆柱面与所述褶皱相交，其交线是完整的环形波浪线；或者至少以轴线241为轴心作任意圆柱面与远端孔252的临近区域内的褶皱相交，其交线是完整的环形波浪线。在此称其为圆柱形波浪环以区别于背景技术中所述的平面环形波浪环。所述远端244可以看成无数个直径逐渐增大的完整圆柱形波浪环堆砌而成。
每个所述褶皱250均包括在褶皱峰256和褶皱谷258之间延伸的褶皱壁257。所述褶皱250从环形波浪线253开始横向向外延伸且所述褶皱250部分与所述圆柱壁246延伸相交。在所述褶皱250和圆柱壁246之间包含多个切断槽254，所述多个切断槽254将所述褶皱250和圆柱壁246割裂开，从而形成多个筋256将所述褶皱250和圆柱壁246连接起来。在本实例中，所述褶皱峰256和褶皱壁257被12个切断槽254切断，使其不与所述圆柱壁246相交，而所述褶皱谷258通过12个筋256与所述圆柱壁246连接。即所述褶皱250的褶皱峰256及大部分的所述褶皱壁257处于悬空断开状态。且所述褶皱250横向向外延伸时，所述褶皱的深度逐渐增加；所述褶皱壁的深度可以沿着轴线241方向测量褶皱峰和褶皱谷之间的距离得到。
实施例二与实施例一的主要区别在于，实施例二的所述褶皱250横向向外延伸时，仅其褶皱谷258与所述圆柱壁246延伸相交，而实施例一的所述褶皱150横向向外延伸时，其褶皱峰和褶皱谷同时与所述圆柱壁146延伸相交。如前文所述，当褶皱向外侧或内侧舒张时，所述褶围绕褶皱与圆柱壁的过渡区域旋转舒张。然而实施例一中褶皱峰和褶皱谷旋转的力臂不一致，因此增加了额外的变形力。本领域的技术人员应该可以理解，实施例二中所述褶皱250围绕其褶皱谷258与筋256的相交处旋转舒张，其旋转力臂基本相等，因而可将额外变形力降至最低。
图18-21详细的描绘了本发明的第三个实施例保护装置340的结构和组成。所述保护装置340具有中心轴线341，所述保护装置340包含近端342和远端344。所述近端342包含法兰348和大致均布与法兰348之上的孔349。
所述远端344包含多个褶皱350，多个所述褶皱350围绕轴线341整体呈碟形排列 并限定出远端孔352。本实例包含16个所述褶皱350。更具体的，所述远端孔352由完整的环形波浪线353所限定。且所述环形波浪线353的形成方式为其环形波浪大体处于一个圆柱面上。本领域的技术人员应该可以理解，由于所述保护装置的褶皱深度较小，通常褶皱深度小于2mm，所述环形波浪线353的形成方式还可以为其环向波浪完全处在一个圆锥面上，由于褶皱深度较小则这种倾斜的环形波浪不会较大程度的增加被所述保护装置覆盖的密封膜的裸露面积。因此不能理解为所述环形波浪线353必须完全处于一个圆柱面上；但以轴线341为轴心作任意圆柱面与所述褶皱相交，其交线是完整的环形波浪线；或者至少以轴线341为轴心作任意圆柱面与所述远端孔353的临近区域内的褶皱相交，其交线是完整的环形波浪线。在此称其为圆柱形波浪环以区别于背景技术中所述的平面环形波浪环。所述远端344可以看成无数个直径逐渐增大的完整圆柱形波浪环堆砌而成。
每个所述褶皱350均包括在褶皱峰356和褶皱谷358之间延伸的褶皱壁357。所述褶皱350从环形波浪线353开始横向向外延伸并与所述法兰348相交。且所述褶皱150横向向外延伸时，所述褶皱的深度逐渐减小；所述褶皱壁的深度可以沿着轴线141方向测量褶皱峰和褶皱谷之间的距离得到。所述褶皱深度减小的速率可以通过理论计算和简单试验确定，从而使得插入大直径器械时，所述褶皱整体舒张时的旋转力臂一致。
图22-23详细的描绘了一种包含所述保护装置340的密封膜组件380的结构组成和装配关系。所述密封膜组件380还包括下固定环320，上固定环370和密封膜330。所述密封膜330包含近端开口332和远端孔333；所述远端孔333由密封唇334所限定；中心密封壁335从密封唇334延伸至凸缘336；外部浮动部分337从凸缘336延伸至近端332。所述密封膜330和保护装置340被夹在下固定环320和上固定环370之间。而且所述下固定环320的柱子321与所述组件380中其他部件上相应的孔对准。所述柱子321与上固定环370的孔371过盈配合，从而使得整个密封膜组件380处于压缩状态。所述保护装置360用于保护所述密封膜130的中心密封体335，使其免受插入的手术器械的锋利边造成的穿孔或撕裂。
图24-25描绘了所述密封膜组件380中插入大直径器械(12.8mm器械)时的模拟变形图。通常所述保护装置340由半刚性材料制成；或者采用刚性材料制成但由于其壁厚较薄而表现为半刚性；而密封膜330通常由硅胶，天然橡胶，异戊橡胶等弹性材料制成。当插入大直径器械时，所述密封膜唇334胀大到合适的密封唇334a以容纳插入的器械，所述保护装置340的所有褶皱也同时舒张到足够的尺寸以容纳插入的器械。本领域的技术人员应该可以理解，由于保护装置340具有半刚性，其褶皱通常不能完全舒张；即舒张后 的保护装置340依然存在较小的环形波浪353a。如果所述保护装置340舒张后其环形波浪353a接近所述密封唇334a，则容易导致漏气或密封不可靠；而如果所述环形波浪353a距离所述密封唇334a足够远以保证其密封可靠性，必然导致所述密封膜330更多的密封壁裸露，从而增加被刺穿或撕裂的风险，并一定程度增加器械与密封膜的真实接触面积从而增大了摩擦阻力。
图26-28详细的描绘了本发明的第四个实施例保护装置440的结构和组成。图26-28几何结构的数字标号与图18-21相应的数字标号相同，相同数字标号的表示结构是基本等同的。所述保护装置440具有中心轴线341，所述保护装置440包含近端342和远端344。所述近端342包含法兰348和大致均布与法兰348之上的孔349。所述远端344包含多个褶皱350，多个所述褶皱350围绕轴线341整体呈碟形排列并限定出远端孔452。更具体的，所述远端孔452由环形波浪线453所限定，且所述环形波浪线453的形成方式为其环形波浪大体处于一个圆柱面上。每个所述褶皱350均包括在褶皱峰356和褶皱谷358之间延伸的褶皱壁357。所述褶皱350从环形波浪线353开始横向向外延伸并与所述法兰348相交。
所述保护装置440与所述保护装置340的形状和结构基本相似，区别在于所述保护装置440的远端孔452不是由完整的环形波浪线453所限定的。所述保护装置440在所述远端孔452的临近区域内不是完整无缝隙的。为方便量化，定义当Di为设计通过保护装置的手术器械的最大直径时，以轴线341为轴心作直径为Di的圆柱与所述远端344相交，从其交线到远端孔452的区域称为通孔的临近区域。本实例中，在所述远端孔452的临近区域内，所述褶皱峰356被槽459断开。所述槽459可随保护装置440一起直接注塑成型，其槽的宽度尽量小；所述槽459也可以通过二次加工而成，例如在保护装置340基础上直接切口而成，则所述槽459的宽度接近零。虽然本实例中在所述远端孔452的临近区域内，所有的褶皱峰包含断开的槽；然而褶皱峰和褶皱谷也可同时开槽，或者一部分褶皱谷开槽；或者一部分褶皱峰开槽。
以所述保护装置440为例，当插入外部器械时，例如插入钛夹钳时，由于所述槽459的宽度远小于所插入钛夹钳的工作刃口的宽度，且由于所述保护装置包含多个褶皱，钛夹钳的工作刃首先接触保护装置的褶皱并挤压迫使所述褶皱局部舒张；此时所述槽459通常不会增大，反而会出现材料交叠，仍然能防止钛夹钳的工作刃接触被保护装置440覆盖的密封壁。而当钛夹钳完全插入密封膜组件后，所述槽459又起到减少前文所述保护装置舒张后通孔的临近区域的环形波浪的作用，可使设计露出所述保护装置的密封壁面积 更少，从而减小密封膜被损坏的概率并能一定程度的降低整体舒张力和器械在密封膜中移动的产生的摩擦阻力。另外，由于所述保护装置440是半刚性的，若远端孔452的临近区域是完整无缝隙的，则所述环形波浪线453的周长必须大于设计插入的最大直径器械的外周周长。而当所述远端孔452的临近区域包含多个槽459时，则所述环形波浪想的周长不必大于设计插入的最大直径器械的外周周长。因此可以减小所述褶皱尺寸或减少所述褶皱的数目，从而简化模具和提供加工效率。
图29-31详细的描绘了本发明的第五个实施例保护装置540的结构和组成。所述保护装置540具有中心轴线541，所述保护装置540包含近端542和远端544。所述近端542包含多个悬臂546和多个缺口548。所述远端544包含多个褶皱550，多个所述褶皱550围绕轴线541整体呈碟形排列并限定出远端孔552。本实例包含16个所述褶皱550。更具体的，所述远端孔552由完整的环形波浪线553所限定。所述环形波浪线553的波浪峰相对轴线541的距离大于其波浪谷相对轴线541的距离，且所述环形波浪线553的形成方式为其环形波浪大体处于一个圆锥面上。以轴线541为轴心作任意圆柱面与所述褶皱相交，其交线是完整的环形波浪线；或者至少以轴线541为轴心作任意圆柱面与远端孔552的临近区域内的褶皱相交，其交线是完整的环形波浪线。在此称其为圆柱形波浪环以区别于背景技术中所述的平面环形波浪环。所述远端544可以看成无数个直径逐渐增大的完整圆柱形波浪环堆砌而成。
每个所述褶皱550均包括在褶皱峰556和褶皱谷558之间延伸的褶皱壁557。所述褶皱550从环形波浪线553开始横向向外延，且所述褶皱550横向向外延伸时，所述褶皱的深度逐渐减小；所述褶皱壁的深度可以沿着轴线541方向测量褶皱峰和褶皱谷之间的距离得到。本领域一个普通的技术人员可以想到，所述保护装置540可以采用粘接，机械固定或焊接或者其他方式固定在密封膜上。
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。例如改变所述褶皱峰或褶皱谷处的倒角可改变褶皱峰或褶皱谷处的壁厚。例如本发明展示的实例中，所述褶皱的横断面为近似三角形，然而也可以是近似矩形或近似梯形。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 (8)

  1. 一种用于微创手术的穿刺器密封膜保护装置，所述保护装置包含近端开口，远端和中心轴线，其特征在于：
    a)所述远端包含多个褶皱，每个所述褶皱包含褶皱峰，褶皱谷以及从褶皱峰延伸至褶皱谷的褶皱壁；
    b)多个所述褶皱围绕中心轴线呈碟形排列并限定出远端孔，以中心轴线为圆心作任意圆柱面与远端孔临近区域的所有褶皱相交其交线是完整的波浪环线。
  2. 如权利要求1所述的保护装置，其特征在于，在远端孔临近区域内，所述褶皱峰或褶皱谷全部或部分包含切口或切槽。
  3. 如权利要求1所述的保护装置，其特征在于，所述近端开口还包括凸台和从近端延伸至远端的圆柱壁，以及从所述圆柱壁延伸出的并与所述褶皱谷相交的筋；而所述褶皱峰及其临近的褶皱壁呈悬臂状。
  4. 如权利要求2所述的保护装置，其特征在于，所述保护装置的近端包括固定法兰。
  5. 一种密封膜组件，包括如权利要求3所述的保护装置，还包括密封膜；所述密封膜包括近端开口，凸缘和远端孔，所述密封膜还包括从远端孔延伸至凸缘内部密封体和从远端延伸至近端的外部浮动部分；且所述凸缘还包括环形内凹槽，所述保护装置的凸台内嵌入所述环形内凹槽中。
  6. 一种密封膜组件，包括如权利要求4所述的保护装置，还包括密封膜，下固定环和上固定环；所述密封膜包括近端开口，凸缘和远端孔，所述密封膜还包括从远端孔延伸至凸缘内部密封体和从远端延伸至近端的外部浮动部分；所述密封膜和保护装置固定在上固定环和下固定环之间。
  7. 一种器械密封组件，包含如权利要求5或6所述的任一所述密封膜组件，还包括上壳和上盖，所述密封膜的近端被固定在所述上壳和上盖之间。
  8. 一种穿刺器，包含如权利要求7所述器械密封组件，还包括套管，鸭嘴密封和下盖；所述鸭嘴密封被固定在套管和下盖之间形成第一密封组件；所述器械密封组件和第一密封组件之间通过快锁结构固定在一起。
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US11446058B2 (en) 2020-03-27 2022-09-20 Covidien Lp Fixture device for folding a seal member
US11717321B2 (en) 2020-04-24 2023-08-08 Covidien Lp Access assembly with retention mechanism
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EP3636181A1 (en) * 2018-10-12 2020-04-15 Covidien LP Surgical access device and seal guard for use therewith
US11457949B2 (en) 2018-10-12 2022-10-04 Covidien Lp Surgical access device and seal guard for use therewith
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US11446058B2 (en) 2020-03-27 2022-09-20 Covidien Lp Fixture device for folding a seal member
US11717321B2 (en) 2020-04-24 2023-08-08 Covidien Lp Access assembly with retention mechanism

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CN106175847A (zh) 2016-12-07
CN109157268B (zh) 2023-05-26
US20190142461A1 (en) 2019-05-16
CN106175847B (zh) 2018-12-14
CN109157268A (zh) 2019-01-08

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