WO2018024079A1 - 一种含多维浮动褶皱的穿刺器密封膜 - Google Patents

一种含多维浮动褶皱的穿刺器密封膜 Download PDF

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Publication number
WO2018024079A1
WO2018024079A1 PCT/CN2017/092334 CN2017092334W WO2018024079A1 WO 2018024079 A1 WO2018024079 A1 WO 2018024079A1 CN 2017092334 W CN2017092334 W CN 2017092334W WO 2018024079 A1 WO2018024079 A1 WO 2018024079A1
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WO
WIPO (PCT)
Prior art keywords
pleats
sealing
seal
radial
pleat
Prior art date
Application number
PCT/CN2017/092334
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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
Priority to EP17836261.2A priority Critical patent/EP3492030A4/en
Publication of WO2018024079A1 publication Critical patent/WO2018024079A1/zh
Priority to US16/243,479 priority patent/US20190142462A1/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
    • 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
    • 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
    • A61B2017/00477—Coupling
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3445—Cannulas used as instrument channel for multiple instruments
    • 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

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-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.
  • a 15mm puncturing device usually an inner diameter of 15.8 to 15.9 mm
  • the force ensures a reliable seal for the inserted instrument.
  • the 5mm instrument has a large radial movement in the 15mm casing (defined that the casing axis is axial and defines a radial direction generally perpendicular to the casing axis).
  • the sealing film should be able to move radially and move radially.
  • the radial tensile force of the sealing film must be less than the radial component of the sealing force of the sealing lip. Otherwise, the radial pulling force will damage the application of the 5 mm device. Seal reliability at the time. Reducing the radial pulling force when the sealing film moves in the radial direction, or reducing the sealing lip diameter to increase the sealing lip ring tightening force, helps to maintain the sealing reliability. However, reducing the aperture of the sealing lip inevitably leads to an increase in the tightening force of the sealing lip when the large-diameter instrument is inserted, which in turn leads to a large frictional resistance between the sealing membrane and the instrument.
  • the large frictional resistance is usually It is easy 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. Therefore, a method of reducing the radial pulling force is generally employed.
  • a sealing film composed of an inner sealing body and an outer floating pleat (or a bellows) is disclosed in US Pat. No. 5,407, 433, US Pat. No. 5, 411, 083, US Pat. No. 5, 792, 133, US Pat.
  • the outer floating pleats can reduce the radial pull, thereby ensuring sealing reliability when applying a 5 mm instrument.
  • the shape or structure of the outer floating pleats of the prior art described above are different, there is a common feature that the outer floating pleats are formed by a wrap-containing bus bar that is rotated about the axis of the central hole of the sealing film.
  • the longitudinal axis intersects the outer floating portion through the axis; the intersection line contains one or more radial pleats (or lateral pleats); and the vertical axis intersects with the outer floating pleats at any cross section.
  • the intersection line is a cluster of concentric rings. Define this type of floating pleats as two-dimensional floating pleats.
  • FIG. 1 depicts a typical conventional seal assembly 700.
  • the seal assembly 700 includes an upper case 710, a lower case 720, a sealing film 730, and a protective sheet 760.
  • the sealing membrane 730 includes a proximal opening 732, a distal aperture 733, a sealing lip 734, an inner sealing wall 735, a flange 736 and an outer floating portion 737.
  • the proximal end 732 opening is secured between the upper housing 710 and the lower housing 720;
  • the floating portion 737 includes radial pleats extending from the flange 736 to the proximal end 732 opening, which in this example includes a radial pleat for a total of two cylinders
  • the pleated wall; the radial pleats allow the entire sealing film to radially float in a sealed chamber formed by the upper and lower shells 710, 720.
  • the protective sheet 760 includes a plurality of mutually overlapping sheets 763, a wall 766 and a flange 768; the flange 768 is embedded in the inner groove 738 of the flange 736, thereby fixing the protective sheet 760 In the sealing film 730.
  • a trocar sealing membrane comprising a proximal opening and a distal opening and an outer sealing body extending from the proximal opening to the distal opening and proximally from the distal opening Internal extension Seal.
  • the sealing film includes a central axis and a transverse plane that is substantially perpendicular to the central axis.
  • the distal aperture is formed by a sealing lip for receiving an inserted instrument and forming a seal.
  • the outer seal contains both radial pleats and tangential pleats.
  • the axis is an arbitrary longitudinal section, and the intersection formed by the longitudinal section intersecting the pleated portion of the outer sealing body has at least one radial pleat; any cross section parallel to the transverse plane and the The pleated portions of the outer seal body intersect, the line of intersection is a wrinkle-containing loop, or the portion of the line of intersection is a wrap-containing loop and the other portion is a ring.
  • the wrinkle-containing loop is compared to the aforementioned concentric ring:
  • the deformation of the wrinkle-containing ring mainly represents local bending deformation and displacement; and the deformation of the concentric ring is represented by the deformation of the entire ring into an egg shape; and the deformation force of the wrinkle-containing ring under the condition that the geometrical dimensions are substantially equivalent Less than the deformation force of the concentric ring.
  • a trocar integral sealing membrane for minimally invasive surgery comprising a proximal opening and a distal opening, and an outer sealing body extending from the proximal opening to the distal opening And an inner seal extending from the distal bore to the proximal opening; the outer seal and the inner seal extending to form a flange; the distal bore being formed by a sealing lip for receiving the inserted instrument and forming The seal; wherein the outer seal comprises at least one radial pleat; each radial pleat comprises at least two annular pleat walls and at least one of the annular pleat walls comprises a plurality of tangential pleats.
  • the annular pleat wall comprises an inner annular wall and an outer annular wall; the inner annular wall and/or the outer annular wall comprise a plurality of tangential pleats substantially uniformly distributed; the radial pleats And the tangential pleats constitute a multi-dimensional pleat, and when the multi-dimensional pleats move radially, the deformation of the multi-dimensional pleats mainly manifests as local bending deformation and displacement to reduce the deformation force.
  • the flange includes an annular inner groove.
  • the cross-sectional shape of the radial pleats is V-shaped or U-shaped.
  • the cross-sectional shape of the tangential pleats is V-shaped or U-shaped or a portion is V-shaped and the other portion is U-shaped.
  • the number of the tangential pleats is twelve.
  • a split seal film for minimally invasive surgery comprising an inner seal body and an outer seal body, the inner seal body including a distal end hole and a first flange and a distal end hole An inner sealing wall extending to the first flange; the outer sealing body including a proximal opening and a second flange and an outer sealing wall extending from the proximal opening to the second flange; wherein the outer sealing body comprises at least a radial pleat; each radial pleat includes at least two annular pleat walls and at least one of said annular pleat walls includes a plurality of tangential pleats; said first flange and said second flange being joined.
  • an instrument sealing assembly comprising the sealing membrane, the device
  • the sealing assembly further includes a lower fixing ring, an upper fixing ring, a protection device, an upper casing and an upper cover; the sealing film and the protection device are sandwiched between the upper fixing ring and the lower fixing ring, and the proximal end of the sealing film is open It is sandwiched between the upper casing and the upper cover.
  • a trocar comprising the instrument sealing assembly, further comprising a sleeve, a duckbill seal and a lower lid, the duckbill seal being fixed between the sleeve and the lower cover to form a A seal assembly is secured between the instrument seal assembly and the first seal assembly by a quick lock.
  • Figure 1 is a longitudinal cross-sectional view of a prior art seal assembly
  • FIG. 2 is a simulated deformation diagram of a prior art sealing assembly of the sealing assembly of FIG. 1 with a 5 mm instrument inserted and moved radially to an extreme position;
  • Figure 3 is a perspective, partial, cross-sectional view of the cannula assembly of the present invention.
  • Figure 4 is an exploded view of the sealing membrane assembly of the sleeve assembly of Figure 3;
  • Figure 5 is a perspective partial cross-sectional view of the sealing film assembly of Figure 4.
  • Figure 6 is a perspective view of the integral sealing film shown in Figure 4.
  • Figure 7 is a sectional view taken along line 7-7 of the sealing film shown in Figure 6;
  • Figure 8 is a cross-sectional view taken along line 8-8 of the sealing film shown in Figure 6;
  • Figure 9 is a cross-sectional view taken along line 9-9 of the sealing film shown in Figure 8;
  • Figure 10 is a perspective view of a sealing film of a split type according to a second embodiment of the present invention.
  • Figure 11 is a perspective partial cross-sectional view of the sealing film of Figure 10.
  • Figure 12 is a cross-sectional view taken along line 12-12 of the sealing film shown in Figure 10;
  • Figure 13 is a cross-sectional view taken along line 13-13 of the sealing film of Figure 10;
  • Figure 14 is a perspective view showing a sealing film of a unitary type according to a third embodiment of the present invention.
  • Figure 15 is a cross-sectional view taken along line 15-15 of the sealing film of Figure 14;
  • Figure 16 is a cross-sectional view taken along line 16-16 of the sealing film of Figure 14;
  • Figure 17 is a cross-sectional view taken along line 17-17 of the sealing film of Figure 16;
  • Figure 18 is a perspective view of a sealing film of a unitary type according to a fourth embodiment of the present invention.
  • Figure 19 is a cross-sectional view taken along line 19-19 of the sealing film shown in Figure 18;
  • Figure 20 is a cross-sectional view taken along line 20-20 of the sealing film shown in Figure 18;
  • Figure 21 is a cross-sectional view taken along line 21-21 of the sealing film shown in Figure 20;
  • FIG. 3 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. 3 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. 3 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.
  • FIGS 3-4 depict the composition and assembly relationship of the sealing membrane assembly 180.
  • the sealing film assembly 180 comprises a fixing ring 120, an upper fixing ring 125, an integral sealing film 130 and a protection device 170.
  • the sealing film 130 and the protection device 170 are sandwiched between the lower fixing ring 120 and the upper fixing ring 125.
  • 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 127 of the upper retaining ring 125 such that the entire sealing membrane assembly 180 is in a compressed state.
  • the protective device 170 includes four sequentially overlapping protective sheets 173 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 from the proximal opening to the distal opening.
  • An outer floating portion 137 extends distally from the proximal opening 132; an inner sealing body 135 extends proximally from the distal opening 133; the outer floating portion 137 and the inner sealing body 135 extend to intersect the flange 136.
  • the distal aperture 133 is formed by a sealing lip 134 for receiving an inserted instrument and forming a hermetic seal.
  • the flange 136 is for mounting a protective sheet.
  • 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 170 is made of a semi-rigid thermoplastic elastomer
  • the lower fixing ring 120 and the upper fixing ring 125 are made of a relatively hard plastic material such as polycarbonate.
  • FIG. 6-9 depict the sealing film 130 of the first embodiment of the present invention in more detail.
  • the outer floating portion 137 includes radial pleats 140 (or lateral pleats 140), a wall portion 138 and a wall portion 139.
  • One side of the wall portion 138 intersects the radial pleats 140 and the other side of the flange 136 extends; the one side of the wall portion 139 intersects the radial pleats 140 and the other side thereof
  • the proximal openings 132 extend to intersect.
  • a central axis 169 of the proximal opening a longitudinal section intersecting the radial pleats 140 through the axis 169, the intersection line having a shape that is approximately U-shaped, that is, the radial pleats 140 comprise a U-shaped Radial folds.
  • the radial pleats 140 include an inner annular wall 141, an outer annular wall 151 and a top annular wall 161.
  • the inner annular wall 141 includes a plurality of tangential pleats 142 (or referred to as hoop pleats 142). There are 16 such tangential pleats 142 in this example, although a greater or lesser number of pleats may be employed.
  • Each pleat 142 includes a pleat wall 144 that extends between the pleat peak 145 and the pleat valley 143.
  • the tangential pleats 142 are approximately evenly distributed around the axis 169 on the inner annular wall 141.
  • the outer annular wall 151 includes a plurality of tangential pleats 152 (or referred to as circumferential pleats) 152), in this example, 16 of said tangential pleats 152 are included, although a greater or lesser number of pleats may be employed.
  • Each pleat 152 includes a pleat wall 154 that extends between the pleat peak 155 and the pleat valley 153.
  • the tangential pleats 152 are approximately evenly distributed on the outer annular wall 151 about the axis 169.
  • the top ring wall 161 includes a plurality of tangential pleats 162 (also referred to as hoop pleats 162), which in this example contains 16 of the tangential pleats 162, although a greater or lesser number of pleats may be employed.
  • Each pleat 162 includes a pleat wall 164 that extends between the pleat peak 165 and the pleat valley 163.
  • the tangential pleats 162 are approximately evenly distributed around the axis 169 on the top ring wall 161.
  • a transverse section 168 (not shown) that is generally perpendicular to the axis 169 intersects the radial pleats 140 to form a line of intersections of two inner rings 147 comprising a plurality of V-shaped pleats and Outer ring 157.
  • Such pleats consisting of radial pleats (or lateral pleats) and tangential pleats (also referred to as hoop pleats) are referred to as multi-dimensional pleats (or three-dimensional pleats).
  • the deformation of the multi-dimensional pleats and the two-dimensional pleat deformation phase described in the background Ratio the deformation of the multi-dimensional pleats mainly represents local bending deformation and displacement; and the deformation of the two-dimensional pleats represents deformation of the entire two-dimensional pleats into an egg shape; and the deformation of the multi-dimensional pleats under the condition that the geometrical dimensions are substantially equivalent
  • the force is much smaller than the deformation force of the two-dimensional pleats.
  • the central aperture of the sealing membrane should be small enough (usually 3.8 to 4.0 mm) to ensure the central hole of the sealing membrane for the inserted 5 mm instrument.
  • the radial component of the hoop tightening force is greater than the radial tensile force of the wrinkle deformation at the extreme position to ensure the sealing reliability; if multi-dimensional wrinkles are used, the central aperture of the sealing film can be relatively large (usually 4.4 to 4.6 mm) It is still possible to ensure that the radial component of the sealing film central hole for the tightening force of the inserted 5 mm instrument is greater than the radial tensile force of the wrinkle deformation at the extreme position, thereby ensuring the sealing reliability.
  • the circumferential strain When the central aperture of the sealing membrane is 3.8-4.0 mm, when a large-diameter instrument, such as a 15.8 mm diameter stapler, is inserted, the circumferential strain is 295% to 316%; and when the central aperture of the sealing membrane is 4.4 to 4.6 mm, When inserting a large diameter instrument, such as a 15.8 mm diameter stapler, the circumferential strain is between 243% and 259%. Reducing the radial pulling force when the external floating pleats are deformed can increase the design value of the central aperture of the sealing film, thereby further reducing the hoop strain (stress) when applying a large diameter instrument, thereby reducing the background The frictional resistance described.
  • Figures 10-13 depict a second example of the present invention, a split seal film 230.
  • the sealing film 230 includes an inner sealing body 230b and an outer sealing body 230a.
  • the inner seal body 230b includes a distal end aperture 233 and a first flange 236b and an inner sealing wall 235 that extends from the distal end aperture 233 to the first flange 236b.
  • the outer seal 230a includes a proximal opening 232 and a second flange 236a and an outer sealing wall 237 that extends from the proximal opening 232 to the second flange 236a.
  • the first flange 236b and the second flange 236a may be joined by bonding, welding, riveting, clamping, or other mechanical fixing.
  • a sealing film assembly comprising an outer sealing body 230a, an inner sealing body 230b, a protective device Set, lower retaining ring and upper retaining ring.
  • the inner sealing body 230b, the protection device 160 and the outer sealing body 230a are sequentially stacked together and sandwiched between the lower fixing ring and the upper fixing ring.
  • the inner sealing body 230b, the outer sealing body 230a and the protection device 160 are sequentially stacked together and sandwiched between the lower fixing ring and the upper fixing ring.
  • a gasket or gasket may be added between the inner seal 230b and the outer seal 230a.
  • the use of a split type sealing film can reduce the difficulty in manufacturing the inner seal body and the outer seal mold, and improve the manufacturing precision of the product.
  • the outer sealing wall 237 includes radial pleats 240 (or lateral pleats 240), wall portions 238 and wall portions 239.
  • One side of the wall portion 238 extends intersecting the radial pleats 240 and the other side thereof intersects the second flange 236a; one side of the wall portion 239 intersects the radial pleats 240 and the other The side intersects the proximal opening 232.
  • the radial pleat 240 includes an inner annular wall 241, an outer annular wall 251 and a top annular wall 261.
  • the inner annular wall 241 includes a plurality of tangential pleats 242 (or referred to as hoop pleats 242). There are 16 such tangential pleats 242 in this example, although a greater or lesser number of pleats may be employed. Each pleat 242 includes a pleat wall 244 that extends between the pleat peak 245 and the pleat valley 243. The tangential pleats 242 are approximately evenly distributed about the axis 269 on the inner annular wall 241.
  • Such pleats consisting of radial pleats (or lateral pleats) and tangential pleats (also referred to as hoop pleats) are referred to as multi-dimensional pleats (or three-dimensional pleats) as described in the first embodiment above. It will be understood by those skilled in the art that the effect of reducing the wrinkle deformation force during radial movement is not as good as that of the first embodiment as compared with the first embodiment; however, compared with the two-dimensional wrinkles described in the background, the embodiment The multi-dimensional pleats in the second still have the effect of reducing the radial displacement deformation force of the pleats.
  • FIGS. 14-17 depict a third example sealing membrane 330 of the present invention.
  • the sealing membrane 330 includes a proximal opening 332, a distal aperture 333, and a sealing wall extending from the proximal opening 332 to the distal aperture 333.
  • An outer floating portion 337 extends distally from the proximal opening 332; an inner sealing body 335 extends proximally from the distal opening 333; the outer floating portion 337 and the inner sealing body 335 extend to intersect the flange 336.
  • the distal aperture 333 is formed by a sealing lip 334 for receiving an inserted instrument and forming a hermetic seal.
  • the flange 336 includes an annular inner groove 331 for mounting the guard 760.
  • the outer floating portion 337 includes radial pleats 340 (or lateral pleats 340), wall portions 338 and wall portions 339.
  • One side of the wall portion 338 intersects the radial pleats 340 and the other side of the flange 336 extends; the one side of the wall portion 339 intersects the radial pleats 340 and the other side thereof
  • the proximal openings 332 extend to intersect. Defining a central axis 369 of the proximal opening 332; through the axis 369 as a longitudinal section and the The radial pleats 340 intersect, the intersection of which is approximately U-shaped, i.e., the radial pleats 340 comprise a U-shaped radial pleat.
  • the radial pleats 340 include an inner annular wall 341, an outer annular wall 351 and a top annular wall 361.
  • the inner annular wall 341 includes a plurality of tangential pleats 342 (or referred to as hoop pleats 342). There are 12 such tangential pleats 342 in this example, although a greater or lesser number of pleats may be employed.
  • Each pleat 342 includes a pleated sidewall 344 that extends between the pleated top wall 345 and the pleated bottom wall 343.
  • the tangential pleats 342 are approximately evenly distributed on the inner annular wall 341 about the axis 369.
  • the outer annular wall 351 includes a plurality of tangential pleats 352 (also referred to as hoop pleats 352), which in this example contains twelve of the tangential pleats 352, although a greater or lesser number of pleats may be employed.
  • Each pleat 352 includes a pleated sidewall 354 that extends between the pleated top wall 355 and the pleated bottom wall 353.
  • the tangential pleats 352 are approximately evenly distributed about the axis 369 on the outer annular wall 351.
  • a transverse section 368 (not shown) that is generally perpendicular to the axis 369 intersects the radial pleats 340, forming an intersection line that is two clusters of inner rings 347 that include a plurality of U-shaped pleats and Outer ring 357.
  • the cross-sectional shape of the tangential pleats 142 and the tangential pleats 152 of the first embodiment is approximately V-shaped; and the cross-sectional shapes of the tangential pleats 342 and the tangential pleats 352 of the third embodiment are approximately U-shaped;
  • the first embodiment has an approximate effect in reducing the radial tensile force when the outer floating portion is radially moved to the extreme position.
  • the sealing membrane 430 includes a proximal opening 432, a distal aperture 433, and a sealing wall extending from the proximal opening 432 to the distal aperture 433.
  • An outer floating portion 437 extends distally from the proximal opening 432; an inner sealing body 435 extends proximally from the distal opening 433; the outer floating portion 437 and the inner sealing body 435 extend to intersect the flange 436.
  • the distal aperture 433 is formed by a sealing lip 434 for receiving an inserted instrument and forming a hermetic seal.
  • the flange 436 is used to mount the guard 170.
  • the outer floating portion 437 includes radial pleats 440 (or lateral pleats 440), a wall portion 438 and a wall portion 439.
  • One side of the wall portion 438 intersects the radial pleats 440 and the other side of the flange 436 extends; one side of the wall portion 439 intersects the radial pleats 440 and the other side thereof
  • the proximal openings 432 extend to intersect. Defining a central axis 469 of the proximal opening 432; intersecting the radial pleats 440 through a longitudinal section of the axis 469, the shape of the intersection is approximately V-shaped, that is, the radial pleats 440 comprise a V-shape Radial folds.
  • the radial pleats 440 include an inner annular wall 441 and an outer annular wall 451.
  • the inner annular wall 441 includes a plurality of tangential pleats 442 (or referred to as hoop pleats 442). There are 12 such tangential pleats 442 in this example, although a greater or lesser number of pleats may be employed.
  • Each pleat 442 includes a pleated sidewall 444 that extends between the pleat peak 445 and the pleat valley 443.
  • the tangential pleats 442 are approximately evenly distributed on the inner annular wall 441 about the axis 469.
  • the outer annular wall 451 includes a plurality of tangential pleats 452 (also referred to as hoop pleats 452), which in this example contains twelve of the tangential pleats 452, although a greater or lesser number of pleats may be employed.
  • Each pleat 452 includes a pleated sidewall 454 that extends between the pleat peak 455 and the pleat valley 453.
  • the tangential pleats 452 are approximately evenly distributed around the axis 469 on the outer annular wall 451. As shown in FIG.
  • a transverse section 468 (not shown) that is generally perpendicular to the axis 469 intersects the radial pleats 440, forming an intersection line that is two clusters of inner rings 347 that include a plurality of V-shaped pleats and Outer ring 357.
  • the radial pleats 140 of the first embodiment have a cross-sectional shape that is approximately U-shaped; and the radial pleats 440 of the fourth embodiment have a cross-sectional shape that is approximately V-shaped; and the fourth embodiment and the first embodiment reduce the outer portion.
  • the radial force of the floating portion when moving radially to the extreme position has an approximate effect.
  • the shape of the radial pleats may be approximately U-shaped, or may be approximately V-shaped, approximately triangular or any open polygon.
  • the radial pleats described in this example contain only one pleat, although a plurality of radial pleats may also be employed.
  • the cross-sectional shape of the tangential pleats may be approximately U-shaped; approximately V-shaped or a portion of the tangential pleats are U-shaped and the other portion of the tangential pleats is V-shaped.
  • the approximate U-shape and the approximate V-shape described in this example cannot be limited to a U-shape or a V-shape.

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Abstract

一种含多维浮动褶皱的穿刺器密封膜，密封膜（130）包含近端开口（132）和远端孔（133），以及从近端开口（132）向远端孔（133）延伸的外部密封体和从远端孔（133）向近端开口（132）延伸的内部密封体（135）。外部密封体和内部密封体（135）延伸相交形成凸缘（136）。远端孔（133）由密封唇（134）形成，用于容纳插入的器械并形成密封。外部密封体至少包含一个径向褶皱（140），每个径向褶皱（140）至少包括两个环形褶皱壁且至少一个环形褶皱壁包含多个切向褶皱（142,152,162）。在几何尺寸基本等同的条件下，多维褶皱的变形力远小于二维褶皱的变形力。

Description

一种含多维浮动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10～15mm)。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15mm规格穿刺器(通常内径为15.8～15.9mm)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。5mm器械在15mm套管中有很大径向移动空间(定义套管轴线为轴向，定义大致垂直于套管轴线的方向为径向)。而进行手术时，常常需要从各个极限的角度操作器械。因此所述密封膜应能够径向移动且径向移动时密封膜受到的径向拉力必须小于密封唇的所述环箍紧力的径向分力，否则所述径向拉力将破坏应用5mm器械时的密封可靠性。减小密封膜径向移动时的径向拉力，或减小密封唇孔径以增加密封唇环箍紧力都有助于维持密封可靠性。然而减小密封唇孔径必然导致插入大直径器械时所述密封唇的环箍紧力增大，进而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。因此通常采用减小所述径向拉力的方法。
美国专利US5407433，US5411483，US5792113，US5827228，US7789861，US7988671中分别披露了由内部密封体和外部浮动褶皱(或称为波纹管)组成的密封膜。所述外部浮动褶皱可以减小所述径向拉力，从而保证应用5mm器械时的密封可靠性。虽然前述现有技术中的外部浮动褶皱的形态或结构各有不同，但有一个共同点，即所述外部浮动褶皱都是由一条含有褶皱的母线，围绕密封膜中心孔的轴线旋转形成的。过所述轴线作任意纵剖面与外部浮动部分相交；其交线含有一个或多个径向褶皱(或称为横向褶皱)；而垂直所述轴线作任意横剖面与外部浮动褶皱相交，形成的交线是一簇同心圆环。定义此类型的浮动褶皱为二维浮动褶皱。
图1描绘了现有的一种典型的密封组件700。所述密封组件700包含上壳710，下壳720，密封膜730和保护片760。所述密封膜730包含近端开口732，远端孔733，密封唇734，内部密封壁735，凸缘736和外部浮动部分737。所述近端732开口被固定在上壳710和下壳720之间；浮动部分737包含从凸缘736延伸至近端732开口的径向褶皱，本实例中包含一个径向褶皱共两个圆柱形褶皱壁；所述径向褶皱使得整个密封膜可以在所述上壳710和下壳720形成的密封仓中径向浮动。所述保护片760包含多个相互搭接的片763，壁766和凸缘768；所述凸缘768内嵌于所述凸缘736的内凹槽738中，从而使所述保护片760固定在所述密封膜730中。
图2描绘了所述密封组件700中插入5mm器械并向某一侧移动时的模拟变形图，该图中忽略了所述密封壁735的变形。理论分析并结合图2可知，密封膜径向浮动时，需迫使浮动部分737的两个圆柱形褶皱壁变成鸡蛋形；即需迫使前文所述的所有的“同心圆环”全部变形为近似椭圆形，这将产生较大的径向拉力。现有技术中通常通过减小浮动褶皱的壁厚来减小所述“同心圆环”的变形力，现有技术中所述褶皱的壁厚通常为0.15～0.25mm，这导致产品的模具精度要求高，模具复杂，制造过程中的不良率高，从而增加了生产成本。
到目前为止，还没有披露更有效的减小所述浮动部分“同心圆环”变形时的径向拉力的方法。
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，所述密封膜包含近端开口和远端孔以及从近端开口向远端孔延伸的外部密封体和从远端孔向近端开口延伸的内部密 封体。所述密封膜包含中心轴线和大致与所述中心轴线垂直的横平面。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。所述外部密封体同时包含径向褶皱和切向褶皱。即过所述轴线作任意纵剖面，所述纵剖面与所述外部密封体的褶皱部分相交形成的交线，至少含有一个径向褶皱；作任意平行于所述横平面的横剖面与所述外部密封体的褶皱部分相交，其交线为含有褶皱的环，或者所述交线一部分为含有褶皱的环而另一部分为圆环。本领域的技术人员一定可以理解，当插入小直径器械(例如5mm器械)时并径向(横向)移动到某一极限位置时，所述含有褶皱的环与前述同心圆环相比：所述含有褶皱的环其变形主要表现局部弯曲变形和位移；而所述同心圆环的变形表现为整个圆环变形为鸡蛋形；在几何尺寸基本等同的条件下，所述含有褶皱的环的变形力小于同心圆环的变形力。
在本发明的一个目的，提出一种用于微创手术的穿刺器整体式密封膜，所述密封膜包含近端开口和远端孔，以及从近端开口向远端孔延伸的外部密封体和从远端孔向近端开口延伸的内部密封体；所述外部密封体和所述内部密封体延伸相交形成凸缘；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；其中，所述外部密封体至少包含一个径向褶皱；每个径向褶皱至少包括两个环形褶皱壁且至少一个所述环形褶皱壁包含多个切向褶皱。
在本发明的一个方面，其中，所述环形褶皱壁包含内侧环壁和外侧环壁；所述内侧环壁和/或外侧环壁包含基本均匀分布的多个切向褶皱；所述径向褶皱和切向褶皱构成多维褶皱，当所述多维褶皱径向移动时，所述多维褶皱的变形主要表现为局部弯曲变形和位移从而减小变形力。
在本发明的一个方面，其中，所述凸缘包含环形内凹槽。
在本发明的又一个方面，其中，所述径向褶皱的截面形状为V型或U型。
在本发明的又一个方面，其中，所述切向褶皱的截面形状为V型或U型或者一部分是V型而另一部分是U型。
在本发明的又一个方面，其中，所述切向褶皱的数目为12个。
在本发明的又一个目的，提出一种用于微创手术的分体式密封膜，包括内部密封体和外部密封体，所述内部密封体包含远端孔和第一凸缘以及从远端孔延伸至第一凸缘的内密封壁；所述外部密封体包含近端开口和第二凸缘以及从近端开口延伸至第二凸缘的外密封壁；其中，所述外部密封体至少包含一个径向褶皱；每个径向褶皱至少包括两个环形褶皱壁且至少一个所述环形褶皱壁包含多个切向褶皱；所述第一凸缘和第二凸缘相连接。
在本发明的又一个目的，提出一种器械密封组件，其中包括所述密封膜，所述器械 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。
在本发明的又一个目的，提出一种穿刺器，包含所述器械密封组件，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装置固定在一起。
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是现有技术的密封组件的纵向剖面图；
图2是现有技术图1的密封组件中插入5mm器械并径向移动至极限位置时的模拟变形图；
图3是本发明套管组件的立体的局部的剖视图；
图4是图3所示套管组件中的密封膜组件的分解图；
图5是图4所示密封膜组件的立体局部剖视图；
图6是图4所示整体式密封膜的立体图；
图7是图6所示密封膜的7-7剖视图；
图8是图6所示密封膜的8-8剖视图；
图9是图8所示密封膜的9-9剖视图；
图10是本发明的第二个实施例分体式的密封膜立体图；
图11是图10所示密封膜的立体局部剖视图；
图12是图10所示密封膜的12-12剖视图；
图13是图10所示密封膜的13-13剖视图；
图14是本发明的第三个实施例整体式的密封膜立体图；
图15是图14所示密封膜的15-15剖视图；
图16是图14所示密封膜的16-16剖视图；
图17是图16所示密封膜的17-17剖视图；
图18是本发明的第四个实施例整体式的密封膜立体图；
图19是图18所示密封膜的19-19剖视图；
图20是图18所示密封膜的20-20剖视图；
图21是图20所示密封膜的21-21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3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3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3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3-4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包含固定环120，上固定环125，整体式的密封膜130和保护装置170组成。所述密封膜130和保护装置170被夹在下固定环120和上固定环125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125的孔127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170包含4个顺序搭接的保护片173，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以及从近端开口延伸至远端孔的密封壁。外部浮动部分137从所述近端开口132向远端延伸；内部密封体135从所述远端孔133向近端延伸；所述外部浮动部分137和内部密封体135延伸相交于凸缘136。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。所述凸缘136用于安装保护片。
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170采用半刚性的热塑性弹性体；而下固定环120和上固定环125采用聚碳酸酯等相对较硬的塑胶材料制成。
图6-9更细致的描绘了本发明的第一个实施例密封膜130。所述外部浮动部分137包含径向褶皱140(或称为横向褶皱140)，壁部分138和壁部分139。所述壁部分138的一侧与所述径向褶皱140延伸相交而其另一侧与凸缘136延伸相交；壁部分139的一侧与所述径向褶皱140延伸相交而其另一侧与所述近端开口132延伸相交。定义所述近端开口的中心轴线169；过所述轴线169作纵剖面与所述径向褶皱140相交，其交线的形状为近似U型，即所述径向褶皱140包含一个U型的径向褶皱。所述径向褶皱140包含内侧环壁141，外侧环壁151和顶部环壁161。
所述内侧环壁141包含多个切向褶皱142(或称为环向褶皱142)。本实例中含16个所述切向褶皱142，然而也可以采用更多数目或较少数目的褶皱。每个褶皱142均包括在褶皱峰145和褶皱谷143之间延伸的褶皱壁144。所述切向褶皱142围绕所述轴线169近似均布在内侧环壁141上。所述外侧环壁151包含多个切向褶皱152(或称为环向褶皱 152)，本实例中含16个所述切向褶皱152，然而也可以采用更多数目或较少数目的褶皱。每个褶皱152均包括在褶皱峰155和褶皱谷153之间延伸的褶皱壁154。所述切向褶皱152围绕所述轴线169近似均布在外侧环壁151上。所述顶部环壁161包含多个切向褶皱162(或称为环向褶皱162)，本实例中含16个所述切向褶皱162，然而也可以采用更多数目或较少数目的褶皱。每个褶皱162均包括在褶皱峰165和褶皱谷163之间延伸的褶皱壁164。所述切向褶皱162围绕所述轴线169近似均布在顶部环壁161上。如图9所示，作大致垂直于所述轴线169的横切面168(未示出)与所述径向褶皱140相交，形成的交线为两簇包含多个V型褶皱的内环147和外环157。
为方便描述，将这种由径向褶皱(或称横向褶皱)和切向褶皱(或称为环向褶皱)组成的褶皱称为多维褶皱(或称为三维褶皱)。本领域的技术人员一定可以理解，当插入小直径器械(例如5mm器械)时并径向(横向)移动到某一极限位置时，所述多维褶皱的变形和背景所述的二维褶皱变形相比：所述多维褶皱的变形主要表现局部弯曲变形和位移；而所述二维褶皱的变形表现为整个二维褶皱变形为鸡蛋形；在几何尺寸基本等同的条件下，所述多维褶皱的变形力远小于所述二维褶皱的变形力。研究表明，以15mm规格穿刺器为例，若采采用二维外部浮动褶皱，则其密封膜的中心孔径要足够小(通常3.8～4.0mm)，才能确保密封膜中心孔对于插入的5mm器械的环箍紧力的径向分力大于所述极限位置时褶皱变形的径向拉力，从而确保其密封可靠性；若采用多维褶皱，其密封膜中心孔径可相对较大(通常4.4～4.6mm)，仍然能够确保密封膜中心孔对于插入的5mm器械的环箍紧力的径向分力大于所述极限位置时褶皱变形的径向拉力，从而确保其密封可靠性。而密封膜中心孔径为3.8～4.0mm时，插入大直径器械，例如直径为15.8mm的吻合器时，其环向应变为295％～316％；而密封膜中心孔径为4.4～4.6mm时，插入大直径器械，例如直径为15.8mm的吻合器时，其环向应变为243％～259％。减小所述外部浮动褶皱变形时的径向拉力，可以增大密封膜中心孔径的设计取值，进而可以较大程度的降低应用大直径器械时的环向应变(应力)，从而降低背景所述的摩擦阻力。
图10-13描绘了本发明的第二个实例，分体式密封膜230。所述密封膜230包括内部密封体230b和外部密封体230a。所述内部密封体230b包含远端孔233和第一凸缘236b以及从远端孔233延伸至第一凸缘236b的内密封壁235。所述外部密封体230a包含近端开口232和第二凸缘236a以及从近端开口232延伸至第二凸缘236a的外密封壁237。所述第一凸缘236b和第二凸缘236a之间可采用粘接，焊接，铆接，夹紧固定或其他机械固定方式连接。例如，一种密封膜组件，包含外部密封体230a，内部密封体230b，保护装 置，下固定环和上固定环。所述内部密封体230b，保护装置160和外部密封体230a依次堆叠在一起，并将其夹在下固定环和上固定环之间固定。或者，所述内部密封体230b，外部密封体230a和保护装置160依次堆叠在一起，并将其夹在下固定环和上固定环之间固定。本领域一个普通技术人员可以想到，所述内部密封体230b和外部密封体230a之间可以增加垫圈或垫片。采用分体式的密封膜，可以降低内部密封体和外部密封的模具制造难度，并提高产品的制造精度。
所述外密封壁237包含径向褶皱240(或称为横向褶皱240)，壁部分238和壁部分239。所述壁部分238的一侧与所述径向褶皱240延伸相交而其另一侧与第二凸缘236a延伸相交；壁部分239的一侧与所述径向褶皱240延伸相交而其另一侧与所述近端开口232延伸相交。定义所述近端开口的中心轴线269；过所述轴线269作纵剖面与所述径向褶皱240相交，其交线的形状为近似U型，即所述径向褶皱240包含一个U型的径向褶皱。所述径向褶皱240包含内侧环壁241，外侧环壁251和顶部环壁261。
所述内侧环壁241包含多个切向褶皱242(或称为环向褶皱242)。本实例中含16个所述切向褶皱242，然而也可以采用更多数目或较少数目的褶皱。每个褶皱242均包括在褶皱峰245和褶皱谷243之间延伸的褶皱壁244。所述切向褶皱242围绕所述轴线269近似均布在内侧环壁241上。
如前文实施例一所述，将这种由径向褶皱(或称横向褶皱)和切向褶皱(或称为环向褶皱)组成的褶皱称为多维褶皱(或称为三维褶皱)。本领域的技术人员一定可以理解，实施例二与实施例一相比，其减小径向移动时褶皱变形力的效果不如实施例一；但与背景所述的二维褶皱相比，实施例二中的多维褶皱仍然具有更好的减小褶皱径向移动变形力的效果。
图14-17描绘了本发明的第三个实例密封膜330。密封膜330包括近端开口332，远端孔333以及从近端开口332延伸至远端孔333的密封壁。外部浮动部分337从所述近端开口332向远端延伸；内部密封体335从所述远端孔333向近端延伸；所述外部浮动部分337和内部密封体335延伸相交于凸缘336。所述远端孔333由密封唇334形成，用于容纳插入的器械并形成气密封。所述凸缘336包含环形内凹槽331用于安装保护装置760。
所述外部浮动部分337包含径向褶皱340(或称为横向褶皱340)，壁部分338和壁部分339。所述壁部分338的一侧与所述径向褶皱340延伸相交而其另一侧与凸缘336延伸相交；壁部分339的一侧与所述径向褶皱340延伸相交而其另一侧与所述近端开口332延伸相交。定义所述近端开口332的中心轴线369；过所述轴线369作纵剖面与所述 径向褶皱340相交，其交线的形状为近似U型，即所述径向褶皱340包含一个U型的径向褶皱。所述径向褶皱340包含内侧环壁341，外侧环壁351和顶部环壁361。
所述内侧环壁341包含多个切向褶皱342(或称为环向褶皱342)。本实例中含12个所述切向褶皱342，然而也可以采用更多数目或较少数目的褶皱。每个褶皱342均包括在褶皱顶部壁345和褶皱底部壁343之间延伸的褶皱侧壁344。所述切向褶皱342围绕所述轴线369近似均布在内侧环壁341上。所述外侧环壁351包含多个切向褶皱352(或称为环向褶皱352)，本实例中含12个所述切向褶皱352，然而也可以采用更多数目或较少数目的褶皱。每个褶皱352均包括在褶皱顶部壁355和褶皱底部壁353之间延伸的褶皱侧壁354。所述切向褶皱352围绕所述轴线369近似均布在外侧环壁351上。如图16所示，作大致垂直于所述轴线369的横切面368(未示出)与所述径向褶皱340相交，形成的交线为两簇包含多个U型褶皱的内环347和外环357。实施例一的所述切向褶皱142和切向褶皱152的截面形状为近似V型；而实施例三的所述切向褶皱342和切向褶皱352的截面形状为近似U型；实施例三和实施例一在减小所述外部浮动部分径向移动至极限位置时的径向拉力方面，具有近似的功效。
图18-21描绘了本发明的第四个实例密封膜430。密封膜430包括近端开口432，远端孔433以及从近端开口432延伸至远端孔433的密封壁。外部浮动部分437从所述近端开口432向远端延伸；内部密封体435从所述远端孔433向近端延伸；所述外部浮动部分437和内部密封体435延伸相交于凸缘436。所述远端孔433由密封唇434形成，用于容纳插入的器械并形成气密封。所述凸缘436用于安装保护装置170。
所述外部浮动部分437包含径向褶皱440(或称为横向褶皱440)，壁部分438和壁部分439。所述壁部分438的一侧与所述径向褶皱440延伸相交而其另一侧与凸缘436延伸相交；壁部分439的一侧与所述径向褶皱440延伸相交而其另一侧与所述近端开口432延伸相交。定义所述近端开口432的中心轴线469；过所述轴线469作纵剖面与所述径向褶皱440相交，其交线的形状为近似V型，即所述径向褶皱440包含一个V型的径向褶皱。所述径向褶皱440包含内侧环壁441和外侧环壁451。
所述内侧环壁441包含多个切向褶皱442(或称为环向褶皱442)。本实例中含12个所述切向褶皱442，然而也可以采用更多数目或较少数目的褶皱。每个褶皱442均包括在褶皱峰445和褶皱谷443之间延伸的褶皱侧壁444。所述切向褶皱442围绕所述轴线469近似均布在内侧环壁441上。所述外侧环壁451包含多个切向褶皱452(或称为环向褶皱452)，本实例中含12个所述切向褶皱452，然而也可以采用更多数目或较少数目的褶皱。 每个褶皱452均包括在褶皱峰455和褶皱谷453之间延伸的褶皱侧壁454。所述切向褶皱452围绕所述轴线469近似均布在外侧环壁451上。如图20所示，作大致垂直于所述轴线469的横切面468(未示出)与所述径向褶皱440相交，形成的交线为两簇包含多个V型褶皱的内环347和外环357。
实施例一的所述径向褶皱140的截面形状为近似U型；而实施例四的所述径向褶皱440的截面形状为近似V型；实施例四和实施例一在减小所述外部浮动部分径向移动至极限位置时的径向拉力方面具有近似的功效。
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。由于密封膜的尺寸较小，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，则密封膜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。
本领域的技术人员容易理解，所述径向褶皱的形状，可以为近似U型，也可以为近似V型，近似三角形或任意开口多边形。本实例中所述径向褶皱仅含有一个褶皱，然而也可以采用多个径向褶皱。所述切向褶皱的截面形状可以是近似U型；近似V型或者一部分切向褶皱为U型而另一部分切向褶皱为V型。例如本实例中所描述的近似U型和近似V型，不能被限制为其形状必须为U型或V型。
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。例如本发明的实例中详细描述了组成所述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 (10)

  1. 一种用于微创手术的穿刺器整体式密封膜，所述密封膜包含近端开口和远端孔，以及从近端开口向远端孔延伸的外部密封体和从远端孔向近端开口延伸的内部密封体；所述外部密封体和所述内部密封体延伸相交形成凸缘；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；其特征在于，所述外部密封体至少包含一个径向褶皱；每个径向褶皱至少包括两个环形褶皱壁且至少一个所述环形褶皱壁包含多个切向褶皱。
  2. 如权利要求1所述的密封膜，其特征在于，所述环形褶皱壁包含内侧环壁和外侧环壁；所述内侧环壁和/或外侧环壁包含基本均匀分布的多个切向褶皱；
    所述径向褶皱和切向褶皱构成多维褶皱，当所述多维褶皱径向移动时，所述多维褶皱的变形主要表现为局部弯曲变形和位移从而减小变形力。
  3. 如权利要求1所述的密封膜，其特征在于，所述凸缘包含环形内凹槽。
  4. 如权利要求1所述的密封膜，其特征在于，所述径向褶皱的截面形状为V型或U型。
  5. 如权利要求1所述的密封膜，其特征在于，所述切向褶皱的截面形状为V型或U型或者一部分是V型而另一部分是U型。
  6. 如权利要求5所述的密封膜，其特征在于，所述切向褶皱的数目为12个。
  7. 一种用于微创手术的分体式密封膜，包括内部密封体和外部密封体，所述内部密封体包含远端孔和第一凸缘以及从远端孔延伸至第一凸缘的内密封壁；所述外部密封体包含近端开口和第二凸缘以及从近端开口延伸至第二凸缘的外密封壁；其特征在于，所述外部密封体至少包含一个径向褶皱；每个径向褶皱至少包括两个环形褶皱壁且至少一个所述环形褶皱壁包含多个切向褶皱；所述第一凸缘和第二凸缘相连接。
  8. 如权利要求7所述的密封膜，其特征在于，所述环形褶皱壁包含内侧环壁和外侧环壁；所述内侧环壁和/或外侧环壁包含基本均匀分布的多个切向褶皱；
    所述径向褶皱和切向褶皱构成多维褶皱，当所述多维褶皱径向移动时，所述多维褶皱的变形主要表现为局部弯曲变形和位移从而减小变形力。
  9. 一种器械密封组件，其特征在于包括如权利要求1-8中任一项所述的密封膜，所述器械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。
  10. 一种穿刺器，包含如权利要求9所述的器械密封组件，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 组件之间通过快锁装置固定在一起。
PCT/CN2017/092334 2016-08-01 2017-07-10 一种含多维浮动褶皱的穿刺器密封膜 WO2018024079A1 (zh)

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