CN106214229B - A kind of puncture outfit diaphragm seal containing groove - Google Patents

A kind of puncture outfit diaphragm seal containing groove Download PDF

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Publication number
CN106214229B
CN106214229B CN201610630376.XA CN201610630376A CN106214229B CN 106214229 B CN106214229 B CN 106214229B CN 201610630376 A CN201610630376 A CN 201610630376A CN 106214229 B CN106214229 B CN 106214229B
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groove
diaphragm seal
wall
sealing lip
main body
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CN106214229A (en
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朱莫恕
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Chengdu Five Medical Technology Co Ltd
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Chengdu Five Medical Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles

Abstract

The present invention relates to a kind of puncture outfit diaphragm seal containing groove.The diaphragm seal includes proximal openings and remote stomidium and the sealed wall that proximal openings are extended to from remote stomidium.The remote stomidium is formed by sealing lip, and for accommodating the instrument being inserted into and forming hermetic seal, the sealing lip is cylindrical.It includes main body turret wall and multiple grooves that the sealed wall, which has proximal end face and distal face, the sealed wall,.The groove is recessed from the proximal end of main body turret wall towards distal face and the proximally facing face of opening of the groove, and the shape of groove described in the visual angle from distal face shows as muscle raised on distal face.The diaphragm seal further includes extending the flange for intersecting or extending intersection with main body turret wall and the groove simultaneously with the main body turret wall, and the external floating part at least one transverse fold of proximal openings is extended to from flange.The groove increases circumferential perimeter, the hoop strain (stress) when reducing using major diameter instrument, to reduce hoop clamp force and the frictional resistance.

Description

A kind of puncture outfit diaphragm seal containing groove
Technical field
The present invention relates to Minimally Invasive Surgery instrument more particularly to a kind of puncture outfit sealing structures.
Background technology
Puncture outfit is in a kind of Minimally Invasive Surgery (especially hard tube endoscope-assistant surgery), for establishing the artificial channel for entering body cavity Surgical instrument.Usually it is made of sheath assembly and puncture needle.Its clinical general occupation mode is:First cut on patient skin Osculum is opened, then puncture needle is run through into sheath assembly, however penetrates stomach wall through skin opening together and enters body cavity.Once into body Puncture needle is removed after chamber, leaves the channel that sheath assembly passes in and out body cavity as instrument.
In hard tube endoscope-assistant surgery, stable pneumoperitoneum need to be usually established and maintain, to obtain enough surgical procedure spaces.Set Tube assembly is usually by casing, shell, diaphragm seal (also known as instrument seal) and zero sealing (also known as automatic-sealed) composition.Described sleeve pipe It is penetrated to body cavity outside body cavity, the channel of body cavity is passed in and out as instrument.The shell connects casing, zero sealing with diaphragm seal At a sealing system.Zero sealing is generally not provided the sealing for insertion instrument, and is automatically closed when instrument is removed And form sealing.The diaphragm seal banding instrument and forms sealing when instrument is inserted into.
In a kind of typical endoscopic surgery, 4 puncture channels usually are established in patient's stomach wall, i.e., 2 small internal diameter casing Component (usual 5mm) and 2 large diameter sheath assemblies (usual 10~12mm).Usually enter patient via small internal diameter sheath assembly Internal instrument is only completed auxiliary operation;One of large diameter sheath assembly is as endoscope path way;And another large diameter The main thoroughfare that sheath assembly is performed the operation as doctor.Main thoroughfare described herein, about 80% time apply 5mm instruments; About 20% time applies other major diameter instruments;And 5mm instruments need frequent switching with major diameter instrument in performing the operation.Using small straight Diameter appliance time longest, sealing reliability are more important;Using when major diameter instrument often be operation in critical stage (such as Vessel sealing and tissue suture), switch convenience and operating comfort is more important.
Fig. 1 and Fig. 2 depicts a kind of sheath assembly 700 of existing typical 12mm specifications.Described sleeve pipe component 700 includes Lower casing 710, upper casing 720 and is clipped in diaphragm seal 730 between the upper casing 720 and lower casing 710, Duckbill seal 750.The lower casing 710 central through holes 713 limited comprising elongated tubular 711.The upper casing 720 includes the proximal end bore 723 that inner wall 721 limits.It is described Diaphragm seal 730 includes proximal openings 732, and remote stomidium 733, sealing lip 734, truncated cone sealed wall 735, flange 736 and outside are floating Dynamic part 737.The distal openings 733 are formed by sealing lip 734.Define sealing lip axis be 741, definition generally perpendicular to The transverse plane 742 of axis 741;The angle of the revolution busbar for defining truncated cone sealed wall 735 and the transverse plane 742 is guide angle ANG1。
Such as Fig. 1, when being inserted into 5mm instruments, it is approximately considered the hoop clamp force that only deformation of sealing lip 734 generates and ensures for instrument Reliable sealing.And when being performed the operation, it often need to be from the operating angle instrument of each limit.5mm instruments have very in 12mm casings Big radial direction activity space, this makes 734 radial force of sealing lip larger.Therefore sealing lip 734 should have the 5mm instruments of insertion Enough hoop clamp forces just can guarantee its sealing reliability.
Such as Fig. 2, make an a diameter of Di(Di> 5mm) cylinder intersect with the sealed wall 735, form a diameter of Di's Intersection 738.If those skilled in the art are centainly it is appreciated that be inserted into a diameter of DiInstrument, then the sealed wall 735 is from sealing The strain (stress) in lip 734 to the region of intersection 738 is larger, this region is referred to as sealing lip close region (or area of stress concentration Domain);And the sealed wall 735 from intersection 738 to the region of flange 736 its strain (stress) it is smaller.The diameter D of insertion instrumenti The bounds of difference, the sealing lip close region (region of stress concentration) are of different sizes.For convenience of quantization, D is worked as in definitioniFor When design passes through the maximum gauge of the surgical instrument of diaphragm seal, the region from sealing lip 734 to the intersection 738 is faced for sealing lip Near field.
Such as Fig. 3, when being inserted into major diameter instrument (such as 12.8mm), the sealing lip 734 will swell to it is suitably sized with Accommodate the instrument being inserted into;The sealed wall 735 is divided into conical walls 735c and cylindrical wall 735d two parts;The cylindrical wall 735d It is wrapped on instrument outer surface, forms the package region of stress high concentration.Define the friendship of conical walls 735c and cylindrical wall 735d Line is 738a;After removing instrument, the sealed wall 735 under natural conditions is reverted to, defining the intersection 738a rebounds is Radius is DxAnnulus 738b (not shown)s;The intersection 738b is bending line of demarcation when being inserted into major diameter instrument.It is fixed The revolution busbar of the justice conical walls 735c and the angle of the transverse plane 742 are ANG2, and ANG2 > ANG1;It is inserted into big straight The sealed wall 735 rotates diastole by fulcrum of the intersection of flange 736 and sealed wall 735 when diameter instrument.Define the cylindrical wall The height of 735d is Ha.The HaIt is not definite value, the remote stomidium is of different sizes, and the sealing lip size is different, the sealed wall Wall thickness is different, and the factors such as the guide angle difference or insertion instrument diameter difference will all lead to HaIt is different.
When in operation operation be inserted into diaphragm seal in instrument movement when, between package region and the insertion instrument in the presence of compared with Big frictional resistance.The larger frictional resistance is typically easy to cause diaphragm seal varus, and operating comfort is poor, operation fatigue, even Cause sheath assembly the defects of fixed not firm on patient's stomach wall, influences the performance of sheath assembly.
In defect caused by the frictional resistance is larger, diaphragm seal varus is to influence sheath assembly performance most serious One of problem.As Fig. 4 is easy to happen diaphragm seal varus when extracting major diameter instrument outward.The sealed wall after varus 735 are divided into cylindrical wall 735e, conical walls 735f, conical walls 735g;The cylindrical wall 735e is wrapped in instrument outer surface, is formed The package region of stress high concentration.The height for defining the cylindrical wall 735e is Hb, usual HbMore than Ha;When extracting instrument Frictional resistance be more than insertion instrument when frictional resistance;This differentia influence operative doctor operating experience even results in operation doctor The raw illusion of production.It is more serious, diaphragm seal after varus possibly into proximal end bore 723, i.e., diaphragm seal be deposited in instrument with it is described Cause between inner wall 721 stuck.Being disclosed respectively in United States Patent (USP) US7112185, US7591802 prevents arranging for diaphragm seal varus It applies;These measures can effectively reduce varus probability but cannot thoroughly solve the problems, such as varus.
Reduce the frictional resistance, simplest method is the friction coefficient reduced using lubricating grease between two contact surfaces.But The reliability of the measure is bad.When clinical application, due to instrument it is long-term repeatedly scrape with diaphragm seal and a variety of instruments Switch repeatedly, is easy that lubricating grease is made to be detached from and be pulled away from sealing film surface, so as to cause insufficient lubrication.
A kind of screening glass for being close to diaphragm seal is disclosed in United States Patent (USP) US5342315.The screening glass both can avoid device The sharp edge of tool damages diaphragm seal, and because screening glass skin-friction coefficient is less than diaphragm seal skin-friction coefficient, therefore can be certain The reduction frictional resistance of degree.But the sealing lip close region generally can not be completely covered by screening glass.
A kind of diaphragm seal containing muscle is disclosed in United States Patent (USP) US5827228, i.e. diaphragm seal is since near centre bore, tool There are several muscle radially, the muscle reduces the contact area between insertion instrument and diaphragm seal, to reduce the friction Resistance.A kind of approximate reinforcing rib is disclosed in European patent EP 0994740 have reduce contact area and increase diaphragm seal axis Effect to tensile strength.
A kind of fold shape diaphragm seal is disclosed in United States Patent (USP) US7842014, is mainly characterized by having corrugated close Seal lip and undulating pleats seal.The pleated structure can increase circumferential perimeter, a degree of reduction hoop clamp force.
A kind of sealing containing yielding slot is disclosed in Chinese invention application CN101480354A (being rejected at present) Film, it is characterised in that since sealing lip, there are several yielding slots on the circular conical surface of diaphragm seal;The wall of the yielding slot Thickness is much smaller than the wall thickness of the circular conical surface;The major diameter instrument of insertion is mainly accommodated by the elongation strain of mutability slot.
Although having disclosed the scheme for much reducing the frictional resistance in the prior art, disclosed technical solution is basic On only have proposition solution in mind from some factor for influencing frictional resistance, the effect for reducing frictional resistance is smaller or unknown It is aobvious.In some schemes even other defect is introduced because improving a factor.Such as increases reinforcing rib on diaphragm seal and can reduce and connect Contacting surface is accumulated, but can increase hoop clamp force simultaneously;It is much smaller than the yielding slot in truncated cone face for example, by using thickness, can cause yielding It is easy to be damaged at slot;Such as the circumferential perimeter of diaphragm seal opening is increased according to waveform sealing lip, to sacrifice Sealing reliability when using 5mm instruments does not increase the circumferential perimeter of diaphragm seal opening but according to corrugated sealing lip, Then wave sealing lip has lost improvement result relative to the sealing lip of pure circle.In a word.Influence the factor of the frictional resistance Very much, the comprehensive function of each factor must be considered from the angle of mechanics and tribology.
Diaphragm seal is usually made of rubber materials such as natural rubber, silicon rubber, isoprene rubbers, and rubber material has super-elasticity And viscoplasticity.Although the mechanical model of rubber deformation process is very complicated, but still can its bullet approximately be described with generalized Hooke law Sexual behaviour;Its viscous behavior is described with newton module.Studies have shown that influence rubber generates frictional force with device contacts Principal element includes:The smaller then frictional force of friction coefficient of two contact surfaces is smaller;The the lubricating condition between two contact surfaces the good, rubs It is smaller to wipe power;The smaller then frictional force of real contact area between two contact surfaces is smaller;Normal pressure between two contact surfaces is smaller then Frictional force is smaller.The present invention considers above-mentioned factor, proposes the resistance that rubs between more perfect reduction diaphragm seal and insertion instrument The solution of power.
Other than aforementioned friction resistance larger impact sheath assembly performance, diaphragm seal stick-slip is also to influence puncture outfit Another key factor of performance.The stick-slip when that is, instrument moves axially in casing, the sealing lip of diaphragm seal and its is faced It is adhered on instrument that (frictional force between instrument and diaphragm seal is mainly static friction at this time when near field opposing stationaryly Power);When and (frictional force between instrument and diaphragm seal is mainly dynamic friction at this time the phenomenon that produced relative sliding with instrument Power);And the stiction is much larger than the kinetic force of friction.The static friction and dynamic friction are alternately present, this causes instrument to exist The resistance moved in diaphragm seal is unstable and movement speed is unstable.It will be understood by those skilled in the art that in Minimally Invasive Surgery, doctor Life can only touch patient organ's organ using instrument, and by the local model of endoscopic images system monitoring instrument working head It encloses.In the case where this limited view tactile blocks, operative doctor is usually using resistance feedback when moving instrument as judgement One of whether normal information of surgical procedure.Diaphragm seal stick-slip affects the comfort of operation, positioning accuracy, or even induces doctor The judgement of raw mistake.
During the use of sheath assembly, the stick-slip is very difficult to avoid completely, but can be reduced.Studies have shown that institute State stick-slip is influenced by two principal elements:One is maximum static friction force and the smaller then stick-slip of kinetic force of friction difference are fainter;Its Second is that the more big then stick-slip of the axial extensional rigidity of diaphragm seal is fainter.Avoid the hoop clamp force between diaphragm seal and instrument excessive, Reduce the real contact area between diaphragm seal and instrument, keeps the good lubrication between diaphragm seal and instrument, can reduce most The difference of big stiction and kinetic force of friction, to reduce stick-slip.Increase the axial extensional rigidity of diaphragm seal simultaneously, it helps Mitigate stick-slip phenomenon.The present invention proposes the measure for improving stick-slip simultaneously.
In conclusion up to the present, there are no a kind of sheath assemblies that can effectively solve foregoing problems.
Invention content
Therefore, it is an object of the present invention to provide a kind of puncture outfit diaphragm seal, the diaphragm seal include proximal openings and Remote stomidium and the sealed wall that proximal openings are extended to from remote stomidium.The remote stomidium is formed by sealing lip, is inserted into for accommodating Instrument and form sealing.The sealed wall has proximal end face and distal face.The diaphragm seal can ensure the 5mm devices for insertion Tool reliably under the premise of sealing, reduces frictional resistance when applying major diameter instrument and improves stick-slip.
As described in background, the package region that sealing lip and its close region are formed when being inserted into major diameter instrument is to cause to rub Wipe the larger root of resistance.The frictional resistance is reduced, the radial stress reduced between instrument and diaphragm seal should be considered, Reduce the package region between instrument and diaphragm seal, reduces the real contact area of instrument and diaphragm seal.Those skilled in the art It is appreciated that according to generalized Hooke law and poisson effect it is found that hoop strain (stress) can be reduced by increasing circumferential perimeter, from And reduce radial strain (stress).It should be noted that the strain of sealing lip can not be reduced by increasing the method for circumferential perimeter (stress), this reduces sealing reliability when causing using 5mm instruments.And since sealing lip close region is using major diameter Stress high concentration when instrument, therefore should quickly increase the circumferential perimeter of sealing lip close region;Sealing lip is faced Region except near field, since strain (stress) is smaller, it may not be necessary to using the measure for increasing circumferential perimeter.In addition, increasing The axial extensional rigidity of sealing lip close region should also be increased while circumferential perimeter and good lubrication is kept (to reduce maximum quiet rubs Wipe the difference of power and kinetic force of friction), so as to improve the stick-slip of sealing lip close region.
In one aspect of the invention, the diaphragm seal includes proximal openings and remote stomidium and is extended to closely from remote stomidium The sealed wall of end opening.The remote stomidium is formed by sealing lip, for accommodating the instrument being inserted into and forming hermetic seal, the sealing Lip is cylindrical.It includes main body turret wall and multiple grooves that the sealed wall, which has proximal end face and distal face, the sealed wall,. The groove is recessed from the proximal end of main body turret wall towards distal face and the proximally facing face of opening of the groove, and from distal face Visual angle described in the shape of groove show as muscle raised on distal face.The diaphragm seal further includes prolonging with the main body turret wall It stretches intersection or extends the flange intersected with main body turret wall and the groove simultaneously, and extend to the tool of proximal openings from flange There is the external floating part of at least one transverse fold.
In a kind of embodiment, the cross sectional shape of the groove is U-shaped, and in close region, the inside of the groove Width B, wherein 0.5≤B≤1mm.The groove and the sealing lip it is circumscribed and extend laterally outward and the depth of groove along Axis direction is gradually reduced.
In another optional embodiment, it is characterised in that the depth of the groove meets following formula at sealing lip:
The depth of H=sealing lips and groove intersection groove
RiThe maximum radius that=design passes through the surgical instrument of diaphragm seal
R0The radius of=sealing lip
The number of P=grooves
In one aspect of the invention, the diaphragm seal includes proximal openings and remote stomidium and is extended to closely from remote stomidium The sealed wall of end opening.The remote stomidium is formed by sealing lip, for accommodating the instrument being inserted into and forming hermetic seal, the sealing Lip is cylindrical.It includes main body turret wall and multiple grooves that the sealed wall, which has proximal end face and distal face, the sealed wall,. The groove is recessed from the proximal end of main body turret wall towards distal face and the proximally facing face of opening of the groove, and from distal face Visual angle described in the shape of groove show as muscle raised on distal face.The groove and the sealing lip are circumscribed and laterally outward Extend and the depth of groove is constant along axis direction.
In one aspect of the invention, the diaphragm seal includes proximal openings and remote stomidium and is extended to closely from remote stomidium The sealed wall of end opening.The remote stomidium is formed by sealing lip, for accommodating the instrument being inserted into and forming hermetic seal, the sealing Lip is cylindrical.It includes main body turret wall and multiple grooves that the sealed wall, which has proximal end face and distal face, the sealed wall,. The groove is recessed from the proximal end of main body turret wall towards distal face and the proximally facing face of opening of the groove, and from distal face Visual angle described in the shape of groove show as muscle raised on distal face.The section of the groove is V-type.
It is a further object to provide a kind of puncture outfit seal assemblies.The seal assembly includes lower fixed ring, Diaphragm seal, protective device, fixed ring, upper shell and upper cover in rigidity;The diaphragm seal and protective device are sandwiched in fixed ring Between lower fixed ring;The diaphragm seal further includes extending the flange intersected with the main body turret wall, and extend from flange To the external floating part at least one transverse fold of proximal openings;The proximal end of the diaphragm seal be sandwiched in upper shell and Between upper cover.
When refer to the attached drawing and detailed description, above-mentioned or other purpose of the invention, feature and advantage will become more Add clear.
Description of the drawings
In order to more fully understand the present invention essence, be described in detail below in conjunction with attached drawing, wherein:
Simulation deformation pattern when Fig. 1 is the sheath assembly insertion 5mm instruments of the prior art;
Fig. 2 is the detail drawing of the diaphragm seal 730 of the prior art;
Simulation deformation pattern when Fig. 3 is the sheath assembly insertion 12.8mm instruments of the prior art;
Simulation deformation pattern when Fig. 4 is the sheath assembly extraction 12.8mm instruments of the prior art;
Fig. 5 is the sectional view of the three-dimensional part of sheath assembly of the present invention;
Fig. 6 is the exploded view of the sealing membrane modules in Fig. 5 described sleeve pipe components;
Fig. 7 is the partial sectional perspective view of sealing membrane modules shown in Fig. 6;
Fig. 8 is that diaphragm seal shown in Fig. 6 omits diaphragm seal stereogram after proximal end and floating part;
Fig. 9 is the reversed isometric view of diaphragm seal shown in Fig. 8;
Figure 10 is the 10-10 sectional views of diaphragm seal shown in Fig. 8;
Figure 11 is the 11-11 sectional views of diaphragm seal shown in Fig. 8;
Figure 12-13 is the figure after the cutting separation of diaphragm seal circumferential direction shown in Fig. 8;
Figure 14 is simulation deformation pattern when being inserted into 12.8mm instruments in diaphragm seal shown in Fig. 8;
Figure 15 is that the figure concealed in deformation pattern after institute's insertion instrument is simulated described in Figure 14;
Figure 16 is the diaphragm seal stereogram of the embodiment of the present invention two;
Figure 17 is the reversed isometric view of diaphragm seal shown in Figure 16;
Figure 18 is the 18-18 partial sectional views of diaphragm seal shown in Figure 16;
Figure 19 is the 19-19 sectional views of diaphragm seal shown in Figure 16;
Figure 20 is the diaphragm seal stereogram of the embodiment of the present invention three
Figure 21 is the reversed isometric view of diaphragm seal shown in Figure 20;
Figure 22 is the 22-22 sectional views of diaphragm seal shown in Figure 20;
Figure 23 is the 23-23 sectional views of diaphragm seal shown in Figure 20;
In all views, identical label indicates equivalent part or component.
Specific implementation mode
Disclosed herein is embodiment of the present invention, it should be understood, however, that disclosed embodiment is only of the invention Example, the present invention can be realized by different modes.Therefore, this disclosure is not to be construed to be restrictive, and It is the basis only as claim, and how basis of the invention is used as introduction those skilled in the art.
Fig. 5 depicts the overall structure of puncture outfit.It is a kind of typical case puncture outfit include 10 (not shown) of puncture needle and casing group Part 20.Sheath assembly 20 has open proximal end 192 and open distal end 31.In the typical application of one kind, puncture needle 10 runs through Then sheath assembly 20 penetrates entire stomach wall through skin opening together and enters body cavity.Once into body cavity, puncture needle 10 is taken Walk and leave the channel that sheath assembly 20 passes in and out body cavity as instrument.The proximal end 192 is in the patient distal end 31 In patient's body.A kind of preferred sheath assembly 20 can be divided into the first seal assembly 100 and the second seal assembly 200.Institute State the cooperation fastening of hook 112 of the card slot 39 and the component 200 of component 100.The cooperation of the hook 112 and card slot 39 is can What one hand was quickly split.This takes out the tissue or foreign matter of patient's body mainly for facilitating when operation.The component 100 and component There are many realization methods for fast lock connection between 200.In addition to the structure of the present embodiment displaying, threaded connection also can be used, rotate Buckle or other quick locking structures.Selectable, the component 100 and component 200 can be designed to the knot that can not quickly split Structure.
Fig. 5 depicts the composition and assembly relation of the first seal assembly 100.Lower housing 30 includes an elongated tubular 32, this is thin Long tube limits the casing 33 through distal end 31 and is connected with shell 34.The lower housing 30 has the inner wall of support Duckbill seal 36 and the air valve mounting hole 37 with inner wall unicom.Spool 82 is mounted in valve body 80 and is installed along in the mounting hole 37. The flange 56 of Duckbill seal 50 is sandwiched between the inner wall 36 and lower cover 60.Fixation between the lower cover 60 and lower housing 30 The modes such as there are many modes, and interference fit can be used, and ultrasonic bonding is glued, and buckle is fixed.Lower cover 60 described in the present embodiment 4 mounting holes 38 of 4 mounting posts 68 and the lower housing 30 be interference fitted, this interference fit makes Duckbill seal 50 be in Compressive state.Described sleeve pipe 32, inner wall 36, Duckbill seal 50, valve body 80 and spool 82 have collectively constituted first chamber.This implementation In example, the Duckbill seal 50 is single seam, but can also use other kinds of closure valve, including tongue type valve, stitches duckbill valve more. When external device runs through the Duckbill seal 50, duckbilled 53 can open, but it is generally not provided relative to the instrument Be fully sealed.When the instrument is removed, the duckbilled 53 is closed automatically, to prevent the fluid in first chamber to external Leakage.
Fig. 5 depicts the composition and assembly relation of the second seal assembly 200.Sealing membrane modules 180 are clipped in upper cover 110 and upper Between shell 190.The proximal end 132 of the sealing membrane modules 180 is fixed on the inner ring 116 of the upper cover 110 and the upper casing Between the inner ring 196 of body 190.There are many fixed forms between the upper shell 190 and upper cover 110, and interference fit can be used, The modes such as ultrasonic welding is glued, and buckle is fixed.The shell 191 of the present embodiment displaying connection type upper shell 190 for being with It is fixed by ultrasonic bonding between the shell 111 of the upper cover 110.This fixation makes the close of the sealing membrane modules 180 End 132 is in compressive state.The centre bore 113 of the upper cover 110, inner ring 116 and sealing membrane modules 180 together constitute second Chamber.
Fig. 6-7 depicts the composition and assembly relation of sealing membrane modules 180.The sealing membrane modules 180 include lower fixation Ring 120, diaphragm seal 130, protective device 160 and upper fixed ring 170.The diaphragm seal 130 and protective device 160 are sandwiched in lower solid Determine between ring 120 and upper fixed ring 170.And the pillar 121 of the lower fixed ring 120 and other component in the component 180 Upper corresponding hole alignment.The pillar 121 and the hole 171 of upper fixed ring 170 are interference fitted, so that entire sealing membrane modules 180 are in compressive state.The protective device 160 includes 4 sequences overlapped screening glass 163, for protecting the diaphragm seal 130 central seal body is perforated or is torn caused by protecting it from the sharp edge of the surgical instrument of insertion.
The diaphragm seal 130 includes proximal openings 132, distal bore 133 and from the sealed wall distally proximally extended, The sealed wall has proximal end face and distal face.The remote stomidium 133 is formed by sealing lip 134, for accommodating the instrument being inserted into And form hermetic seal.The sealing lip 134 can be non-circular, and sealing lip 134 described in this example is approximate circular ring shape. As explained in the background of the invention, sealing lip perimeter should be short enough and sturdy to ensure sealing reliability when applying 5mm instruments.This example Middle sealing lip 134 is cylindrical.
The diaphragm seal 130 further includes flange 136;135 one end of sealed wall connects sealing lip 134 and other end flange connector 136;137 one end flange connector 136 of floating part and the other end connect the proximal end 132.The flange 136 is protected for installing Device 160.The floating part 137 includes one or more radial (transverse direction) folds, so that entire sealing membrane modules 180 It can float in the component 200.
The component 180 can be made of the material much with different characteristics.Such as diaphragm seal 130 uses silica gel, it is different The elastic materials such as penta rubber;Protective device 160 uses semirigid thermoplastic elastomer (TPE);And lower fixed ring 120 and upper fixation Ring 170 is made of relatively hard plastic materials such as makrolon.
The finer one embodiment diaphragm seals 130 for depicting the present invention of Fig. 8-11.To reduce production cost, sealing Film 130 is preferably devised to an entirety, but can also be designed to separated seal body interior from flange 136 and external float portion It is divided to two parts.Embodiment one is improved mainly for the seal body interior.It is stated to simplify, when subsequent descriptions diaphragm seal External floating part and proximal end are not shown.
The axis for defining the sealing lip 134 is 158.Transverse plane 159 of the definition basically perpendicular to axis 158.It is described close It can be approximate frustoconical, near hemispherical or irregular surface of revolution to seal wall 135.Sealed wall 135 is with close in this example 134 arrangement form of sealing lip is surrounded like the mode of circular cone.The sealed wall 135 includes main body turret wall 138 and multiple U-shaped grooves 140.The U-shaped groove 140 is recessed from direction of the proximal end of main body turret wall 138 towards distal face, and the opening direction of groove Proximal end face.The groove 140 from sealing lip 134 extend laterally outward, the multiple groove 140 turns round the main body 138 approximation of wall is divided into multiple portions.I.e. the sealed wall 135 is by main body turret wall 138 and multiple grooves 140 around sealing Lip 134 is with the seamless seal of approximate conical fashion arrangement form.
The groove 140 includes skew wall 141 and side wall 142.One side of the side wall 142 and the main body turret wall 138 It is crossed to form intersection 144a, 144b;And its another side is crossed to form intersection 145a with the skew wall 141,145b.The skew wall 141 one end are crossed to form intersection 146a, 146b with the sealing lip;And its other end is crossed to form intersection with the flange 136 147a, 147b.Transition region 139 extends from sealing lip 134 and is wherein crossed to form intersection 148a with the side wall 142 on one side, 148b;And its another side is crossed to form intersection 149a with main body turret wall 138,149b.
The intersection 144a and intersection 145a (or intersection 144b and intersection 145b) intersects at certain far from 158 direction of axis A point.When being extended laterally outward since sealing lip, the width of the side wall 142 is gradually reduced, i.e., the described groove 140 is from sealing Its depth is gradually reduced along axis direction when lip extends laterally outward.The measurement method of the depth of groove is:Along axis Groove concave bottom point described in orientation measurement arrives the shortest distance of main body turret wall.In this example, the groove at sealing lip is deep Degree is approximately equal to the length of the intersection 148a (148b).Intersection described in this example is straight line, however an ordinary skill people Member can make modification without departing from the present invention so that the intersection is broken line or smooth curve.
The sealed wall 135 of this example include 8 linear grooves, however can also use greater number or fewer number of Or nonlinear groove.The side wall 142 of this example is substantially parallel with the axis 158, makees in sealing lip close region It is arbitrary to be parallel to axis 158 and the simultaneously section of vertical any one of side wall 142, the section be cut it is described recessed The section that slot 140 is crossed to form is approximate U-shaped (section of other grooves also according to said method defines).However for convenience of manufacture, example As conveniently stripped, the side wall 142 can be not parallel with the axis 158;I.e. the section of the groove 140 is approximate trapezoid, Even approximate V-type.
It is rotary shaft with axis 158 such as Figure 12-13, makees a cylindrical surface along the outer circle side wall of the sealing lip 134 and cut Face M1The diaphragm seal 130 is divided into lip portion 156 (such as Figure 12) and exterior portion 157 (Figure 13) by (not shown).The circle Column cut surface M1It is crossed to form intersection 149c with main body turret wall 138, intersection 148c is crossed to form with side wall 142, with skew wall 141 It is crossed to form intersection 146c.The multistage intersection 146c, 148c, 149c form toroid 150c;The multistage intersection 146b, 148b, 149b form toroid 150b;The toroid 150b and 150c limits section 150.
With reference to figure 11-13, it is clear that the perimeter L of the intersection 150c (150b)1It is much larger than the perimeter of sealing lip 134, i.e., recessed Slot plays the role of increasing circumferential perimeter.And L1And the difference of sealing lip perimeter is approximately equal to intersection 148b (148c) length L2 2*P times the number of groove (P be) really play the role of increasing circumferential direction perimeter is the side wall 142, then in recess width Meet under the precondition that can be manufactured, circumferential perimeter can not greatly be increased by increasing recess width.
It will be understood by those skilled in the art that certainly existing some R1Value, makes section M1The exterior portion 157 of segmentation from The section 155 starts, and the change of shape is mainly shown as diaphragm seal partial loop variation and macroscopical displacement, and non-general Micro molecule chain lengthening and integrally stretching deformation.And the lip portion 156, from sealing lip 134 to the section 155, shape Change performance diaphragm seal partial loop variation and integrally stretching deformation comprehensive function.As it can be seen that the groove increases ring To perimeter, the hoop strain (stress) when reducing using major diameter instrument, to reduce hoop clamp force and friction resistance Power.
Such as Figure 12-13, in a kind of optional embodiment, the thickness of the sealed wall 135 is substantially homogeneous, i.e. institute Main body turret wall 138 is stated, the wall thickness of the skew wall 141, side wall 142 is of substantially equal.The substantially homogeneous wall thickness so that described The deformation of sealed wall 135 is substantially homogeneous.But the substantially homogeneous wall thickness is not restricted to the absolute equal of numerical value. When groove number is more, (such as in order to enhance the mould strength of groove) is manufactured for convenience, or considers error component, institute State thickness thin 0.05~0.25mm of the thickness than main body turret wall (skew wall 141) of side wall 142.And the interior skew wall 141, side The wall thickness numerical value of wall 142 and main body turret wall 138 is smaller, for convenience of quantifying, defines the main body turret wall 138 (skew wall 141) Wall-thickness ratio with the side wall 142 between 1~1.5, the wall thickness that is still approximately considered sealed wall 135 be it is substantially homogeneous, Still it does not depart from the scope of the present invention.
The side wall 142 has the function of that the reinforcing rib described in similar background, all side walls 142 strengthen sealing lip jointly The axial extensional rigidity of close region;And the side wall 142 does not increase hoop rigidity while increase axial extensional rigidity, Therefore there is no hoop clamp force is increased while increasing axial rigidity, stick-slip described in background can effectively be reduced.It is wrapped in this example Containing 16 side walls 142, however more or less side walls can also play the role of increasing axial extensional rigidity.
It is selectable, the geometry of the groove 140 it can be designed so that when maximum gauge surgical instrument is inserted into, It is smaller or be even not present in the tight stress of hoop of the sealed wall 135 containing groove.In a kind of alternative, sealing lip With the following formula of depth of groove of the groove intersection:
The depth of H=sealing lips and groove intersection groove
RiThe maximum radius that=design passes through the surgical instrument of diaphragm seal
R0The radius of=sealing lip
The number of P=grooves
Meet the groove of above-mentioned formula, i.e., the perimeter L 1 of the described intersection 150c (150b) is more than 2* π * Ri, then it is inserted into big straight When diameter instrument, for the exterior portion 157 since the section 150, the change of shape is mainly shown as that diaphragm seal is locally curved Song deformation and macroscopical displacement, and non-general micro molecule chain lengthening and integrally stretching deformation.The groove increases circumferential week It is long, the hoop strain (stress) when reducing using major diameter instrument, to reduce hoop clamp force and the frictional resistance.
It will be understood by those skilled in the art that closer to the region of sealing lip, circumferential deformation is bigger (stress is more concentrated). Since the groove for meeting above-mentioned formula has made sealed wall 135 and the stress of sealing lip handover region minimize;Therefore groove Being not necessarily to gradually increase when extending laterally out when the i.e. described grooves of its depth extend laterally out keeps depth constant or deep Degree is gradually reduced.The groove that the depth is constant or depth is gradually reduced, relative to the gradual increased groove of depth, having multiple has Point:The mold of processing and manufacturing is simpler, and manufacturing process is also more stable, therefore the manufacture efficiency higher of diaphragm seal, more economical.Separately Outside, since gradually increased groove does not interfere the transverse shifting (reference chart in the component 200 of the sealing membrane modules 180 6), therefore the axial dimension of seal assembly 200 can be reduced, to reduce the overall dimensions of puncture outfit.It is whole to reduce puncture outfit Size can make manufacture, transport, sterilizing and using all more economically and conveniently.
With reference to figure 12-13, as it was noted above, being separated what the lip portion 156 and 157 people of the exterior portion were Analysis can theoretically be such that the exterior portion 157 is minimized since the hoop clamp force in its sealed wall section 150.However it will The diaphragm seal 130 as a whole when analysis be really not so.Figure 14-15 depicts diaphragm seal when being inserted into major diameter instrument 130 simulation deformation pattern.When being inserted into major diameter instrument, the main body turret wall 138 is divided into main body turret wall 138c and cylinder 138d two parts;And the skew wall 141 is divided into skew wall 141c and cylinder 141d two parts;The side wall 142 is divided into side wall 142c and cylinder 142d two parts.The wherein described cylinder 138d, cylinder 141d, cylinder 142d, which have been collectively constituted, is wrapped in described insert Enter the package region of instrument outer surface.Studies have shown that the design relative to un-grooved, the package region of the seal containing groove compared with It is small.The frictional resistance can be reduced by reducing the package region.2-15 referring to Fig.1 increases the depth of groove at sealing lip, must So increase the transition region 139 between sealing lip 134 and the groove 140 and the main body surface of revolution 138.The transition region 139 and master Body turret wall 138 intersects turning (the intersection 144a and intersection 148a intersections are in obtuse angle), when being inserted into major diameter instrument The turning will be increased to close to 180 degree;The turning of the i.e. described transition region 139 and the turret wall 138 is straightened, this makes institute The flange 136 that sealing lip 134 is stated relative to fixing protector has larger axial displacement, reveals so as to cause more sealed walls Go out the coverage area of protective device 160, and then the frictional resistance is caused to increase.It is total containing 8 grooves 140 in this example 8 skew walls 141, the skew wall 141, which can play the role of pulling sealing lip 134, prevents its from generating axial elongation, to prevent revealing The situation that the sealed wall gone out except protective device increases occurs.In a kind of scheme of optimization, the wall thickness of the skew wall 141 is more than institute The wall thickness for stating side wall 142 and main body turret wall 138 prevents the sealed wall to reinforce the axial extensional rigidity of skew wall 141 135 axial elongations.It is described when the transition region 139 is larger (the i.e. described intersection 148a, when the length of 148b meets aforementioned formula) The width of side wall 142 when groove is laterally extended is gradually reduced, and is additionally aided reduction and is inserted into the sealing 135 when major diameter instrument Stress when local buckling and whole diastole.
The groove 140 can be additionally used in storing lubricating grease.With reference to figure 14-15, when being inserted into major diameter instrument, the groove becomes The package region that shape is formed is smaller, and groove 140 is only flattened compared with segment.Close to package region the groove not flattened, have compared with The function of good deposit lubricating grease.When instrument moves in diaphragm seal, the lubricating grease in the package region is scratched band first It walks, and the lubricating grease closed in the groove not being flattened in package region will add to equipment surfaces, and then as instrument is transported It is dynamic to add to package region.It is B1 in the inner width of the groove of sealing lip close region in a kind of optional scheme, In 0.5≤B1≤1mm.When the inner width of the groove of sealing lip close region is less than 0.5mm, groove structure is difficult to be made It makes;And the bigger depot fat effect of inner width of groove is poorer;Research shows that as inner width≤1mm of groove, depot fat effect Fruit is preferable.Lubrication insecure problem described in the depot fat improved effect of groove background.Help to reduce described in background Stick-slip.
In conclusion the groove, which has, increases circumferential perimeter, reduces package region, reduce between instrument and diaphragm seal Real contact area improves the functions such as lubricating reliability, so as to the larger reduction frictional resistance and reduces stick-slip, simultaneously It also reduces the probability that varus occurs and improves using comfort.
Figure 16-19 describes second example diaphragm seal 230 of the present invention jointly.Part number mark in described Figure 16-19 It is number identical as number designation in Fig. 8-11, indicate that the structure of same numbers label is substantially equivalent.The diaphragm seal 230 includes Distal bore 133, sealing lip 134, sealed wall 235 and flange 136.The remote stomidium 133 is formed by sealing lip 134.It is described close Seal wall 235 one end connection sealing lip 134 and other end flange connector 136.The diaphragm seal 230 has proximal end face and distal face. The axis for defining the sealing lip 134 is 158.Define the transverse plane 159 perpendicular to axis 158.
Sealed wall 235 surrounds 134 arrangement form of sealing lip in a manner of approximate circular cone in this example.The sealed wall 235 Including main body turret wall 138 and multiple grooves 240.The groove 240 is from side of the proximal end of main body turret wall 138 towards distal face To recess, and the proximally facing face of opening of groove.The groove 240 from sealing lip 134 extend laterally outward, it is described more 138 approximation of main body turret wall is divided into multiple portions by a groove 240.I.e. the sealed wall 235 is by main body turret wall 138 and multiple grooves 240 around sealing lip 134 with the seamless seal of approximate conical fashion arrangement form.This example The sealed wall 235 includes 8 linear grooves.
The groove 240 includes skew wall 241 and side wall 242.One side of the side wall 242 and the main body turret wall 138 It is crossed to form intersection 244a, 244b;And its another side is crossed to form intersection 245a with the skew wall 241,245b.The skew wall 241 are crossed to form intersection 146a, 146b with the sealing lip 134.Transition region 139 from sealing lip 134 extend and wherein on one side with The side wall 242 is crossed to form intersection 148a, 148b;And its another side is crossed to form intersection 149a with main body turret wall 138, 149b。
The intersection 244a and intersection 245a (or intersection 244b and intersection 245b) are substantially parallel.The transverse direction since sealing lip When extending outwardly, the width of the side wall 242 is almost the same, i.e., its depth when the described groove 240 is extended laterally outward from sealing lip Degree is basically unchanged.The depth of 240 any position of the groove along skew wall 241 described in 158 orientation measurement of axis by arriving main body Air line distance between turret wall 138 obtains.In this example, the depth of groove at sealing lip is approximately equal to the intersection 148a The length of (148b).Intersection described in this example is straight line, however a those of ordinary skill is not departing from the scope of the invention In the case of can make modification so that the intersection is broken line or smooth curve.
The diaphragm seal 230 has approximate mechanism and size with the diaphragm seal 130, differs only in the groove 240 depth when being extended laterally out from sealing lip is basically unchanged, and when the groove 140 is extended laterally outward from sealing lip Depth is gradually reduced.The skew wall 241, which equally plays the role of pulling sealing lip 134, prevents its from generating axial elongation, to anti- Only expose the situation that the sealed wall except protective device increases to occur.In a kind of scheme of optimization, the wall thickness of the skew wall 241 is big In the wall thickness of the side wall 242 and main body turret wall 138 sealed wall is prevented to reinforce the axial extensional rigidity of skew wall 241 135 axial elongations.The diaphragm seal 230 has the advantages that approximate with diaphragm seal 130.
Figure 20-23 describes the third example diaphragm seal 330 of the present invention jointly.The diaphragm seal 330 includes that distal end is opened Hole 333, sealing lip 334, sealed wall 335 and flange 336.The remote stomidium 333 is formed by sealing lip 334.The sealed wall 335 One end connects sealing lip 334 and other end flange connector 336.The diaphragm seal 330 has proximal end face and distal face.Described in definition The axis of sealing lip 334 is 358.Define the transverse plane 359 perpendicular to axis 358.
The sealed wall 335 includes main body turret wall 338 and multiple V-type grooves 340.The V-type groove 340 is returned from main body Turn direction recess of the proximal end of wall 338 towards distal face, and the proximally facing face of opening of groove.The groove 340 is from sealing lip Start to extend laterally outward at 334, and its depth is gradually reduced when the groove 340 extends laterally outward.The multiple groove 338 approximation of main body turret wall is divided into multiple portions by 340.That is the sealed wall 335 is main body turret wall 338 and multiple Groove 340 is around sealing lip 334 with the seamless seal of approximate conical fashion arrangement form.The sealed wall of this example 335 include 8 linear grooves, however can also use greater number or fewer number of or nonlinear groove.
The groove 340 includes two side walls 342.The sidewall 34 2 and the main body turret wall 338 are crossed to form intersection 345a, 345b;Described two sidewall 34s 2 are crossed to form intersection 346a, 346b;The sidewall 34 2 is crossed to form with transition region 339 Intersection 347a, 347b.The one end the wall part 338a connects main body turret wall 338 and the other end connects the flange 336.It is described The depth of 340 any position of groove by along intersection 346a described in 358 orientation measurement of axis between main body turret wall 138 Vertical range obtains.It is selectable, in a kind of alternative, the depth of folding of the groove 340 and 334 intersection of sealing lip Geometrical relationship meet aforementioned formula.
Those skilled in the art are readily apparent that rational round-corner transition can be to avoid stress concentration or so that some regions change Shape is easier.Since the size of diaphragm seal is smaller, especially sealing lip near zone is smaller.So small size, Chamfering is different, then the shape of diaphragm seal seems to differ greatly.The geometrical relationship between displaying element for clarity, this hair The embodiment of bright description usually removes the figure after fillet.
The many different embodiments and example of the present invention are had shown and described.One ordinary skill of this field Personnel can make adaptive improvement by suitably modified to the method and instrument without departing from the scope of the invention. Such as the protection chip architecture and its fixed form disclosed in United States Patent (USP) US7789861 has been used in the example in the present invention, so And the protection chip architecture and its fixed form of United States Patent (USP) US7988671 disclosures can also be used, also may be used under certain application scenarios Not include protection chip architecture.Such as the approximate U-type groove described in this example and approximate V-groove, its shape cannot be restricted to It is necessary for U-shaped or V-type.Such as extended laterally outward in the present invention repeatedly mentioning the groove from sealing lip, it is so-called " horizontal To extending outwardly " it is not restricted to it to extend track to be straight line, track when extending laterally outward can also be spiral Line, broken line, the curves such as multi-section circular arc line.Such as each intersection for forming the groove is described in detail in the example of the present invention Position relationship and its intersection, multiaspect joint can also be formed using increasing curved surface or make its friendship using by the way of high-order curved surface Line and groove topography seem there is larger difference with example, but as long as the overall thought for meeting the present invention, still believes that and do not take off From the scope of the present invention.Several kinds of amendment schemes are referred, for those skilled in the art, other amendment schemes It is also to be contemplated that.Therefore the scope of the present invention should be according to accessory claim, while being understood not to by specification And the structure that attached drawing shows and records, the particular content of material or behavior are limited.

Claims (7)

1. a kind of diaphragm seal of puncture outfit for Minimally Invasive Surgery, the diaphragm seal is comprising proximal openings and remote stomidium and from distally Hole extends to the sealed wall of proximal openings, and the sealed wall has proximal end face and distal face;The remote stomidium is formed by sealing lip, For accommodating the instrument being inserted into and forming sealing, the sealing lip includes central axis and substantially vertical with the axis horizontal puts down Face;It is characterized in that, the sealed wall includes main body turret wall and multiple grooves, proximal end face of the groove from main body turret wall To distal face recess and the proximally facing face of opening of the groove, and the shape of groove described in the visual angle from distal face is shown as far Raised muscle on end face;The groove and the sealing lip are circumscribed and extend laterally outward and the depth of groove is along axis direction From distally proximally remaining unchanged or be gradually reduced;The main body turret wall is divided into multiple portions by the multiple groove substantially Point, and each described groove includes two side walls, the side wall has the circumferential perimeter of increase and increases axial extensional rigidity Function.
2. diaphragm seal as described in claim 1, it is characterised in that the depth of the groove meets following formula at sealing lip:
The depth of H=sealing lips and groove intersection groove
RiThe maximum radius that=design passes through the surgical instrument of diaphragm seal
R0The radius of=sealing lip
The number of P=grooves.
3. diaphragm seal as claimed in claim 2, it is characterised in that contain 8 grooves.
4. diaphragm seal as claimed in claim 3, it is characterised in that the cross sectional shape of the groove is U-shaped or V-arrangement, or Person's part is U-shaped and another part is V-arrangement.
5. diaphragm seal as claimed in claim 3, which is characterized in that in sealing lip close region, the inside of the groove is wide B is spent, wherein 0.5≤B≤1mm;The diaphragm seal further includes the lubricating grease in the groove, when instrument moves in diaphragm seal When, the lubricating grease adds to package region with apparatus work.
6. diaphragm seal as claimed in claim 3, it is characterised in that further include intersecting or simultaneously with main body turret wall extension Extend flange intersect with main body turret wall and the groove, and from flange extend to proximal openings at least one cross To the external floating part of fold.
7. a kind of puncture outfit seal assembly, it is characterised in that include the diaphragm seal as described in any one of claim 1-5, institute It includes lower fixed ring, upper fixed ring, protective device, upper shell and upper cover to state seal assembly also;The diaphragm seal and protective device It is sandwiched between fixed ring and lower fixed ring;The diaphragm seal further include with the main body turret wall extension intersect or simultaneously with Main body turret wall and the groove extend the flange of intersection, and extend to proximal openings from flange have at least one transverse direction The external floating part of fold, the proximal end of the diaphragm seal are sandwiched between upper shell and upper cover.
CN201610630376.XA 2016-08-02 2016-08-02 A kind of puncture outfit diaphragm seal containing groove Active CN106214229B (en)

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CN107049380B (en) * 2017-06-03 2023-05-26 成都五义医疗科技有限公司 Standardized puncture outfit series products and use method thereof
CN109077783B (en) * 2018-07-06 2021-04-02 青岛市妇女儿童医院 Mammary gland piercing depth under supersound guide
CN108742724B (en) * 2018-07-06 2021-03-12 青岛大学附属医院 Mammary gland piercing depth under supersound guide

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Publication number Priority date Publication date Assignee Title
EP0627233A2 (en) * 1993-04-12 1994-12-07 Ethicon Endo-Surgery Improved seal members for surgical trocars
US5752938A (en) * 1994-09-12 1998-05-19 Richard-Allan Medical Industries, Inc. Seal for surgical instruments
CN101478924A (en) * 2006-04-18 2009-07-08 伊西康内外科公司 Pleated trocar seal
CN101480354A (en) * 2009-01-23 2009-07-15 周星 Tank-type general purpose type radial seal ring for puncture outfit and puncture outfit
CN206434390U (en) * 2016-08-02 2017-08-25 成都五义医疗科技有限公司 A kind of puncture outfit diaphragm seal and puncture outfit seal assembly containing groove

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0627233A2 (en) * 1993-04-12 1994-12-07 Ethicon Endo-Surgery Improved seal members for surgical trocars
US5752938A (en) * 1994-09-12 1998-05-19 Richard-Allan Medical Industries, Inc. Seal for surgical instruments
CN101478924A (en) * 2006-04-18 2009-07-08 伊西康内外科公司 Pleated trocar seal
CN101480354A (en) * 2009-01-23 2009-07-15 周星 Tank-type general purpose type radial seal ring for puncture outfit and puncture outfit
CN206434390U (en) * 2016-08-02 2017-08-25 成都五义医疗科技有限公司 A kind of puncture outfit diaphragm seal and puncture outfit seal assembly containing groove

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