CN107049437A

CN107049437A - A kind of improved thimble assembly containing air bag

Info

Publication number: CN107049437A
Application number: CN201710410213.5A
Authority: CN
Inventors: 朱莫恕
Original assignee: Chengdu Five Medical Technology Co Ltd
Current assignee: Chengdu Five Medical Technology Co Ltd
Priority date: 2017-06-03
Filing date: 2017-06-03
Publication date: 2017-08-18
Anticipated expiration: 2037-06-03
Also published as: WO2018219312A1; CN107049437B; CN109864808A; CN109864808B

Abstract

The present invention relates to a kind of improved thimble assembly containing air bag, include the first seal assembly and the second seal assembly, second seal assembly includes lower case and hollow sleeve that is coupled and extending to distal end, first seal assembly, second seal assembly and hollow sleeve include UNICOM and substantially aligned instrument channel, casing wall of the hollow sleeve comprising inner cylinder and outer cylinder and therebetween；The distal end of the hollow sleeve is also comprising open sleeve pipe lip, and described sleeve pipe lip includes inclination cylinder opening lip and transition lip therebetween, and the inner cylinder and inclination cylinder limit sleeve pipe skew wall；Described sleeve pipe component also includes the inflatable air bag component swollen, air bag skew wall and sleeve pipe skew wall formation taper fit；And fix the completely enclosed taper seam region of formation annular between air bag skew wall and sleeve pipe skew wall the air bag lip and sleeve pipe lip are connected into an entirety.

Description

A kind of improved thimble assembly containing air bag

Technical field

The present invention relates to Minimally Invasive Surgery apparatus, more particularly to a kind of puncture outfit containing air bag.

Background technology

Puncture outfit is the artificial channel for entering body cavity in a kind of Minimally Invasive Surgery (especially laparoscopic surgery) for setting up Operating theater instruments, is generally made up of thimble assembly and puncture needle.Its clinical general occupation mode is：First cut on patient skin Osculum, then puncture needle is run through into thimble assembly, but enter body cavity through penetrating stomach wall at skin openings together.Once into body cavity Puncture needle is removed afterwards, leaves the passage that thimble assembly passes in and out body cavity as apparatus.

In hard tube endoscope-assistant surgery, particularly in laparoscopic surgery, pneumoperitoneum apparatus is generally used to the lasting perfusion of abdominal cavity of patients Gas (such as carbon dioxide) simultaneously maintains stable air pressure (about 13~15mmHg), empty to obtain enough operation techniques Between.Thimble assembly is generally by sleeve pipe, shell, diaphragm seal (also known as instrument seal) and zero sealing (also known as automatic-sealed) composition.Institute State sleeve pipe to penetrate to body cavity outside body cavity, the passage of body cavity is passed in and out as apparatus.The shell is by sleeve pipe, zero sealing and seals Film connects into a sealing system.Zero sealing is generally not provided the sealing for insertion instrument, and when apparatus is removed certainly It is dynamic to close and form sealing.The diaphragm seal banding apparatus and forms sealing when apparatus is inserted.

The abdomen technology of entering of current laparoscopic surgery is broadly divided into two kinds：Open (Hasson methods) and closed (Veress The skill of handling needles).Wherein Hasson methods are mainly used in there may be the patient of adhesion of abdominal wall.Hasson methods generally first along navel upper limb or Lower edge does 2cm otch, and its otch runs through whole stomach wall, then stretches into finger through thus otch and detect, separation abdominal wall and nethike embrane or The adhesion of intestinal tube；Then Hasson cannula systems are inserted under direct-view, and dioxy is injected to abdominal cavity of patients via Hasson sleeve pipes Change carbon gas formation pneumoperitoneum.Closed method is also known as Direct perforantes method, i.e., the epidermis of patient's puncture position stomach wall only is made into small cut Mouthful, puncture needle is then run through into thimble assembly again, stomach wall is penetrated through thus small otch and enters body cavity.

Current disclosed Hasson cannula systems are broadly divided into three classes, such as first kind, U.S. patent Nos A kind of thimble assembly containing hinge arrangement that US5203773 is disclosed, is swollen fixation by hinge rotation, because easily occur leaking and by Gradually abandoned.Taper fixture and common group of smooth thimble assembly that Equations of The Second Kind, such as U.S. patent Nos US5257973 are disclosed Into Hassan cannula systems, Tapered Cup suture is fixed in otch first, then smooth thimble assembly the cone is fixed on In shape fixture, because its is with low cost and extensive use, but it is relative complex and cause secondary injury to patient using operating. The tube assembly containing Air sac cover disclosed in 3rd class, such as U.S. patent Nos US5468248, US6908454, US8888692, institute The inflation that stating air bag can use syringe selective swell thimble assembly being fixed on patient's stomach wall, and release of deflating reduces air bag just In thimble assembly via patient skin incision into and out.Thimble assembly can be firmly fixed to suffer from by the air bag that swells Person's skin incisions and the sealing for realizing contact area, and it is smaller for the injury of patient's wound.But such airbag casing pipe component It is complicated and cost is higher, it is expensive.

The airbag casing pipe component is generally only used for Hasson methods field, up to the present, has disclosed and has had been commercialized Airbag casing pipe component cannot be used in Direct perforantes method substantially.Mainly because the puncture outfit of the tube assembly containing Air sac cover penetrates patient's body wall The resistance of process is too big, is unfavorable for operative doctor control or there is the larger risk for puncturing patient's intracorporeal organ.And relative to Thimble assembly without air bag, the airbag casing pipe component is more reliable and liked by doctor because of its fixation on patient's stomach wall, But the larger application for limiting the airbag casing pipe component in Direct perforantes method field of the puncture force of the tube assembly containing Air sac cover, and And up to the present disclosed and airbag casing pipe component that is having been commercialized, the problem of not yet adequate solution puncture force is larger.

The content of the invention

In order to solve one or more of background technology technical problem, the present invention proposes a kind of improved set containing air bag Tube assembly, comprising the first seal assembly and the second seal assembly, second seal assembly comprising lower case and with its phase Connect and include UNICOM simultaneously to the hollow sleeve of distal end extension, first seal assembly, the second seal assembly and hollow sleeve Substantially aligned instrument channel, casing wall of the hollow sleeve comprising inner cylinder and outer cylinder and therebetween；The hollow sleeve The distal end of pipe is also comprising open sleeve pipe lip, and described sleeve pipe lip includes inclination cylinder opening lip and transition lip therebetween, institute State inner cylinder and tilt cylinder and limit sleeve pipe skew wall；Described sleeve pipe component also includes the inflatable air bag component swollen, is used to The check valve assembly of inflation/deflation and by the air bag component and the gas channel of check valve assembly UNICOM；The air bag component bag Lip containing air bag and the pneumatophore being attached thereto, the air bag lip form the shape and size with described sleeve pipe skew wall to distal end extension The air bag skew wall matched；The air bag lip proximally extends to be connected and smooth transition with the pneumatophore；The air bag component Installed in the outside of the hollow sleeve, the air bag lip is coated on the outer surface of described sleeve pipe lip, the air bag skew wall and set Pipe skew wall formation taper fit；And the fixed completely enclosed taper for forming annular connects between the air bag skew wall and sleeve pipe skew wall Seam region by the air bag lip and sleeve pipe lip so that connect into an entirety.

A kind of optional technical scheme, the air bag lip and pneumatophore have uniform wall thickness T_a3, and 0.05mm≤T_a3≤ 0.1mm。

A kind of optional technical scheme, the pneumatophore includes balloon proximal transition region, air bag Distal transition area and two The air bag main body extended between person, the air bag lip is seamlessly connected and smooth transition, the gas with the air bag Distal transition area Capsule component also includes outer tube, and the outer tube includes distal outer tube and proximal outer tube and the outer tube wall extended therebetween, described Distal outer tube is seamlessly connected that to form overall or described a distal outer tube and the air bag near with the balloon proximal transition region End transition region constitutes connection seam to form an entirety.

A kind of optional technical scheme, the outer tube has outer diameter D_t, the pneumatophore swell after have maximum outside diameter D_b, wherein 1.5D_t≤D_b≤1.7D_t。

A kind of optional technical scheme, the air bag Distal transition area has air bag transition angle A relative to axis_d；It is described Balloon proximal transition region has air bag transition angle A relative to axis_p, and A_d＜ A_p。

A kind of optional technical scheme, the air bag Distal transition area has continuous laterally gradually interior concave circular arc shape, The air bag transition angle A_dWith multiple air bag transition angle A_dx, the transition angle A_dxProximally gradually increased by distal end, Er Qieyue Close to the transition angle A of air bag main body_dxIncreased speed is bigger.

A kind of optional technical scheme, the seam region that the distal outer tube is non-fully closed with outer cylinder formation, and institute The outer surface for stating proximal outer tube and the outer cylinder and the valve seat of check valve assembly is fixed to form completely enclosed near-end seaming zone Domain, forms the gas channel of air bag component and check valve assembly described in UNICOM between the outer tube and outer cylinder.

A kind of optional technical scheme, fixed form includes welding manner or glue between the air bag skew wall and sleeve pipe skew wall Water bonding way.

A kind of optional technical scheme, the included angle A between the inclination cylinder and the inner cylinder_lip, wherein 3 °≤A_lip ≤15°。

Another aspect of the present invention, proposes a kind of manufacture method of described air bag component, wherein, the air bag component Comprising the Part I and Part II that cut-out is divided at its distal outer tube, the balloon proximal transition region proximally extends shape Into balloon proximal opening, its key step is as follows：

Blowing and trimming process：Method blowing manufacture is blown using improved two step note and the acquisition Part I is trimmed；

Extrusion molding and cutting process：The Part II is manufactured using extrusion process and trimmed to suitably sized；

Welding sequence or bonding process：The distal outer tube is overlapped on the outside or inside of the balloon proximal transition region opening, And be bonded to form seam region using welding or glue.

Brief description of the drawings

In order to more fully understand the essence of the present invention, it is described in detail below in conjunction with accompanying drawing, wherein：

Fig. 1 is the schematic perspective view of prior art puncture outfit 5；

Fig. 2 is the close-up schematic view of the distal portions of puncture outfit 5 shown in Fig. 1；

Fig. 3 is the partial sectional view of the distal portions of puncture outfit 5 described in Fig. 2；

Fig. 4 is the schematic perspective view of prior art puncture outfit 7；

Fig. 5 is the partial sectional view of the distal portions of the inner sleeve 54 of prior art；

Fig. 6 is the partial sectional view of the distal portions of the outer tube 55 of prior art；

Fig. 7 is the close-up schematic view of the distal portions of puncture outfit 7 shown in Fig. 4；

Fig. 8 is the partial sectional view of the distal portions of puncture outfit 7 described in Fig. 7；

Fig. 9 is the three-dimensional view of the thimble assembly 100 of the present invention；

Figure 10 is the explosive view of the thimble assembly 100 shown in Fig. 9；

Figure 11 is the schematic perspective view of the lower warehouse 123 shown in Figure 10；

Figure 12 is the axial sectional view of the lower warehouse 123 shown in Figure 11；

Figure 13 is the partial enlarged view of the distal portions of lower warehouse 123 shown in Figure 12；

Figure 14 is the side elevational view of the air bag component 250 described in Figure 10；

Figure 15 is the enlarged drawing of the distal portions partial sectional view of air bag component 250 shown in Figure 14；

Figure 16 is the axial sectional view of the second seal assembly 120 shown in Fig. 9；

Figure 17 is the zoomed-in view of the distal portions of the component 120 shown in Figure 16；

Figure 18 is the partial enlarged view of the check valve assembly 140 shown in Figure 16；

Figure 19 is 19-19 sectional views shown in Figure 18；

Figure 20 is the explosive view of external fixation kit 160；

Figure 21 is the three-dimensional view after the assembling of fixed cover component shown in Figure 20；

Figure 22 is the sectional view of fixation kit shown in Figure 20；

Figure 23 is the schematic perspective view of the thimble assembly 100 comprising external fixation kit；

Figure 24 is the clinical practice simulated view of thimble assembly 100 shown in Figure 23；

Figure 25 is the schematic perspective view of another embodiment of the present invention air bag component 350；

Figure 26 is the axial sectional view of air bag component shown in Figure 25；

Figure 27 is the explosive view of another embodiment of the present invention air bag component 450；

Figure 28 is the axial sectional view of air bag component 450 shown in Figure 27；

Figure 29 is the partial enlarged view of the seam region 491 of air bag component shown in Figure 28；

Figure 30 is the schematic perspective view (not installing air bag) of warehouse 123a under another embodiment；

Figure 31 is the axial sectional view (installing after air bag) of warehouse 123a under another embodiment；

Figure 32 is the partial enlarged view of lower warehouse 123a distal portions shown in Figure 31.

In all views, identical label represents equivalent part or part.

Embodiment

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 restricted, and It is the basis only as claim, and how basis of the invention is used as teaching those skilled in the art.For convenience Statement, the side of follow-up all Proximity operation persons is defined as near-end, and the side away from operator is defined as distal end, and all edges puncture shank The axis direction in portion or the casing axis direction of thimble assembly are defined as axial direction, and substantially vertical axial direction is defined as transverse direction.

Those skilled in the art is to be understood that puncture outfit generally comprises thimble assembly and puncture needle.Thimble assembly Generally include instrument seal, zero sealing and hollow sleeve.For example be hereby incorporated CN201610630336.5, i.e., it is entitled " a kind of puncture outfit sealing system of fold-type ", the thimble assembly disclosed in the Chinese invention application that August in 2016 is submitted on the 2nd. Puncture needle generally includes handle portion, bar part and distal portions.CN201611125444.3 is for example hereby incorporated, that is, invents name Referred to as " improvement without knife visual puncturing pin ", the puncture needle disclosed in the Chinese invention application that on December 9th, 2016 submits.

With reference to Fig. 1-3, a kind of existing puncture outfit 5 for Direct perforantes method includes puncture needle 10, the He of thimble assembly 30 Axis 6.The puncture needle 10 includes handle portion 11 and visual first 13 and the bar part 12 that extends therebetween.From distal end near End, described visual first 13 can be divided into tip portion 19, lance type part 18, transition portion 17 and foundation 16.The top Part 19, lance type part 18, transition portion 17 and foundation 16 are sequentially connected, wherein the tip portion 19 and lance type part 18 connection can be not smooth, because the tip portion and the shape and size of lance type part are relatively tiny sharp, work as institute During stating during puncture needle 10 is pierced into patient muscle or organized, main rise is pierced through and centrifugation.And the lance type part 18, Connection between transition portion 17 and foundation 16 is typically fairshaped smooth transition, in favor of the wound that squeezes and swell And reduce puncture force.Meanwhile, what the foundation 16 also matched comprising the hole size with the sleeve pipe 32 of thimble assembly 30 Column part 15, in favor of puncture needle and thimble assembly formation smooth transition, be conducive to reducing described sleeve pipe component 30 squeeze and Swell the required puncture force of wound.

With continued reference to Fig. 1-3, described sleeve pipe component 30 is comprising seal assembly 31 and sleeve pipe lip 40 and extends therebetween Hollow sleeve 33.Described sleeve pipe 33, which is included, has interior diameter D₁Inner cylinder 35 and with overall diameter D₂Outer cylinder 34 and its Between shroud wall segments 36.A kind of thimble assembly 30 of 12mm specifications, wherein D₁=12.8mm, D₂=14.6mm.Described sleeve pipe lip 40 include the inclination cylinder 48 opening lip 49 and transition lip 47 therebetween, and the inner cylinder 35 and inclination cylinder 48 are limited and inclined Inclined wall part 46.The inclined wall part 46 is T in the wall thickness of opening lip position₁, it is T in the wall thickness of transition lip position₂, The wall thickness of described sleeve pipe wall part 36 is approximately equal to T₂；The wall thickness of the inclined wall part 46 is proximally gradually increased by distal end, The increased speed of usual wall thickness is smaller so that the transition between puncture needle 10 and thimble assembly 30 is more smooth.Now referring primarily to In Fig. 3, a kind of typical design, 0.1mm≤T₁≤ 0.3mm, 0.8mm≤T₂≤ 1.1mm, the inclination cylinder 48 and institute State the included angle A between inner cylinder 35₁, 3 °≤A₁≤15°；Length L of the inclined wall part 46 along axis direction₁, 6mm≤ L₁≤12mm。

In the airbag casing pipe component for having disclosed or having had been commercialized, what such as US5468248 and US6908454 were disclosed includes bullet Property material air bag thimble assembly, generally using bilayer sleeve and be aided with glue be bonded by the way of fixation balloon, its sleeve pipe lip mistake Cross not smooth, be usually not used for the Direct perforantes method field.What such as US8888692 (abbreviation P692) was disclosed contains non-resilient The thimble assembly of material air bag has smaller external diameter, helps to reduce the puncture force of the puncture process.It is hereby incorporated and base The airbag casing pipe component disclosed in patent P692.Fig. 4-8 describes the puncture outfit containing air bag disclosed with the patent P692 substantially etc. Same one kind puncture outfit containing air bag 7.Briefly, the puncture outfit 7 includes puncture needle 10, airbag casing pipe component 50 and axis 8. The airbag casing pipe component 50 includes seal assembly 51 and the sleeve pipe 53 for being attached thereto and extending towards distal end, and described sleeve pipe 53 is wrapped Containing inner sleeve 54 and outer tube 55.Referring now to Fig. 5, the inner sleeve 54 is comprising sleeve pipe lip 60 and connects itself and the seal assembly 51 hollow pipe portion 56.The hollow pipe portion 56, which is included, has interior diameter D₁Inner cylinder 61 and with overall diameter D₄Outer cylinder 63 and shroud wall segments 62 therebetween.Described sleeve pipe lip 60 includes inclination cylinder opening lip 69 and transition lip 67 therebetween 68, the inner cylinder 61 and inclination cylinder 68 limit inclined wall part 66.The hollow pipe portion 56 closes on described sleeve pipe lip 60 Annular groove 70, the annular groove 70 is comprising step surface 79 and transition face 77 and intervenient has diameter D₇Groove Face 78.Described sleeve pipe wall part 62 is divided into boot proximal end wall 62a, casing recess wall 62b and proximal end wall by the groove 70 The parts of 62c tri-.The close region of the hollow pipe portion 56 and the link position of seal assembly 51 includes check valve assembly 52, stream Road 58 extends along described sleeve pipe wall part 62 and by the groove 70 and the UNICOM of check valve assembly 52.With continued reference to Fig. 5, In a kind of typical design, the inclined wall part 66 is T in the wall thickness of opening lip position₃, in transition lip position Wall thickness be T₄, described sleeve pipe groove walls 62b wall thickness T₅, wherein 0.1mm≤T₃≤ 0.3mm, 1.15mm≤T₄≤ 1.25mm, 0.6mm≤T₅≤0.8mm.The included angle A tilted between cylinder 68 and the inner cylinder 61₄, 25 °≤A₄It is≤45 °, described to incline Length L of the inclined wall part 66 along axis direction₄, 2mm≤L₄≤5mm。

Referring now to Fig. 6, hollow pipe portion 88 of the outer tube 55 comprising distal outer tube 89 and proximal outer tube 87 and therebetween.Gas Capsule 80 is arranged on the close region of distal outer tube 89, wherein the air bag 80 includes pneumatophore 81, and from pneumatophore 81 to remote End extension and the air bag Distal transition area 83 being connected with described sleeve pipe distal end 89；And proximally extended by pneumatophore 81 and with institute State the balloon proximal transition region 82 that hollow pipe portion 88 is connected.The air bag distal end 89 is D comprising interior diameter₇, overall diameter is D₈, wall Thickness is T₇Cylindrical wall 84.The wall thickness T of the pneumatophore 81₈Less than the wall thickness T₇, the wall thickness of the transition region 83 (82) is by T₇ Fade to T₈.In a kind of typical design and fabrication scheme, the outer tube 55 is manufactured using stretch-blow method, wherein 0.2mm≤T₇≤ 0.3mm, 0.01mm≤T₈≤ 0.05mm, and D₈＜ D₄。

Fig. 7-8 depicts the cooperation schematic diagram of the inner sleeve 54 and the remote location of outer tube 55.Wherein described outer tube is remote End 89 and air bag 80 are arranged at the annular groove 70, wherein the distal outer tube 89 and the groove surface 78 and step surface 79 Matching.Using binding circle 91, binding circle 92 is respectively by the balloon proximal transition region 82, the air bag Distal transition area 83 and outer Pipe distal end 89 is fixed at groove 70 and is aided with glue sealing.Size after the generally described winding binding of distal outer tube 89 circle 92 Still less than the maximum outside diameter D equal to sleeve pipe lip 60₄.In conjunction with Fig. 3 and Fig. 8, the distal end of the puncture outfit 5, the puncture needle 10 and the transition of described sleeve pipe component 30 it is smooth；And the distal end of the puncture outfit 7, the puncture needle 10 and described sleeve pipe component 50 Transition is not smooth.It is main to include transitional region not smooth at two, one is the chi between described visual first 13 and sleeve pipe lip 60 Very little mutation, causes transition not smooth；The second is the transition of the air bag in itself is not smooth, particularly described air bag Distal transition area It is not smooth that 83 wall thickness dimension inequality and abnormity is caused.One those skilled in the art is it is contemplated that by reducing the folder Angle A4 can reduce the size mutation between described visual first 13 and sleeve pipe lip 60, but reduce the included angle A₄It is simultaneously true again The annular groove 70 is protected with enough intensity, while ensuring D again₈＜ D₄, then the inclined wall part 66 is along axis side To length L4 should be greater than be equal to 10mm.And the pneumatophore 81 and the size of distal outer tube 89 axially are typically larger than and are equal to 20mm.Those skilled in the art be to be understood that due to patient's abdominal space limitation, described sleeve pipe component 30 or 50 it is remote End penetrates the length typically not greater than 20mmm that stomach wall enters abdominal cavity, otherwise influences operation technique or causes puncture process favorite outer Internal organs equivalent risk is damaged, therefore L can not be extended₄To reduce transition mutation.

The influence that transition is mutated for puncture force is quite big：The airbag casing pipe group for the 12mm specifications that such as patent P692 is disclosed Part (without airbag fold) passes through tissue cut, the bar portion of no air bag by when, its resistance is substantially zeroed or very little, works as air bag During by otch, its hump drag reaches 25 pounds；And after using airbag fold technology, its hump drag drops to 13 pounds.This The physical dimension mutation that the random accumulation of pneumatophore that air bag is primarily due to when can reduce puncture through well-regulated folding is produced, from And help largely to reduce penetration Resistance.Those skilled in the art is to be understood that the prominent of the pneumatophore of flexibility Become the resistance difference dissident of different sizes caused through very big, be rigidly mutated between described visual first 13 and sleeve pipe lip 60 and cause resistance to increase It will be apparent from greatly.The visual puncturing pin of disclosure 12mm specifications penetrates patient's abdomen in American invention application US20070066988A1 The puncture force (Direct perforantes method) of wall is about 15 pounds.The operation comfort of usually less than 15 pounds of puncture force preferably, and is higher than 18 pounds will generally influence control of the operative doctor for puncture process.Obviously, if counting air bag in is mutated increased resistance, Yi Jike Depending on being mutated the resistance caused between first 13 and sleeve pipe lip 60, the puncture outfit 7 can not be applied in Direct perforantes method substantially.

Fig. 9-10 depicts the thimble assembly 100 of first embodiment of the invention.Described sleeve pipe component 100 includes axis 101 and axially disposed the first seal assembly 110 and the second seal assembly 120.First seal assembly 100 is included and is clipped in Instrument seal 112 between upper warehouse 111 and upper cover body 113.Second seal assembly, which is included, is clipped in lower cover 121, and under Zero sealing 122 between warehouse 123.The upper warehouse 113, upper cover body 117, lower cover 121 and lower warehouse 123 are sequentially connected group Into shell 103.The shell 103, the composition of the sealing of instrument seal 112 and zero 122 includes the sealing system of substantially aligned hole.Institute State when instrument seal 112 inserts external device in described sleeve pipe component 100 banding apparatus and form sealing；Zero sealing 122 are generally not provided the sealing for insertion instrument, and close automatically when apparatus is removed and form sealing.To save length, Warehouse 111 in omission, instrument seal 112, upper cover body 113, lower cover 121, the structure and its mode that is connected of zero sealing 122 Details describe and state, can combine in foregoing CN201610630336.5 Chinese inventions application on the associated description that discloses understands State structure.Those skilled in the art be to be understood that it is disclosed in the prior art, the instrument seal 112 and zero is close The implementation of envelope 122 has a variety of, such as the fFour piece type instrument seal component disclosed in U.S. patent Nos US8029475, example The apparatus comprising woven cloth disclosed in fold-type instrument seal component as disclosed in US7789861, such as US6482181 is close The fFour piece type zero that sealing assembly, such as US5443452 are disclosed is sealed, such as sealing of duck-beak type zero disclosed in US8034032 etc.. To other disclosed instrument seals, slightly adaptation can also be used for substituting device of the present invention for zero sealing and its shell Tool is sealed, zero sealing, upper warehouse, upper cover body, lower cover etc..

With continued reference to Fig. 9-10, the lower warehouse 123 also comprising lower case 124 and be attached thereto and to distal end extension Hollow sleeve 210.The lower warehouse 123 also includes air bag component 250, air-valve assembly 130 and check valve assembly 140.The gas Valve module 130 includes air valve body 130a and gas valve core 130b, and the gas valve core 130b is fitted into air valve body 130a and transverse direction together Through the air valve mounting hole 125 of the lower case 124.

Referring now to Figure 11-13, the hollow sleeve 210, which is included, has internal diameter D_iInner cylinder 211 and with outer diameter D_oIt is outer Cylinder 213 and thickness therebetween are T_a1Casing wall 212；The distal end of the hollow sleeve 210 is also comprising open sleeve pipe lip 220, described sleeve pipe lip 220 includes the inclination cylinder 227 opening lip 229 and transition lip 228 therebetween, the inner cylinder 211 Sleeve pipe skew wall 226 is limited with cylinder 227 is tilted.Wall thickness of the described sleeve pipe skew wall 226 in the position of opening lip 229 is T_b1, The wall thickness of the position of transition lip 228 is T_b2.The wall thickness of described sleeve pipe skew wall 226 is proximally gradually increased by distal end, usual wall thickness Increased speed is smaller so that the transition between puncture needle and thimble assembly is more smooth.In a kind of preferred design, T_b2 =T_a, and 0.1mm≤T_b1≤ 0.3mm, 0.8mm≤T_b2≤1.1mm.Usual T_b1It is difficult to manufacture and T during ＜ 0.1mm_b1＞ 0.3mm When more serious transition will be caused not smooth.Usual T_b2The then insufficient strength of hollow sleeve 210 during ＜ 0.8mm, and T_b2＞ The external diameter of the hollow sleeve 210 is too big during 1.1mm, the damage of the reduction of unfavorable subthreshold for patient.Another is excellent In the design of change, the included angle A tilted between cylinder 227 and the inner cylinder 211_lip, wherein 3 °≤A_lip≤15°。 The A_lip3 ° of ＜ causes the insufficient strength of sleeve pipe lip 220 and is difficult to manufacture, and the A_lip15 ° of ＞ causes puncture needle and sleeve pipe group Transition between part is not smooth.

With continued reference to Figure 11-13, the proximal location of the hollow sleeve 210 is included to install check valve assembly 140 Valve seat 126.The valve seat 126 includes the mounting hole 126a and heavy platform hole 126b that cylindrical side wall is limited.The hollow sleeve 210 Also comprising (or a plurality of) runner 216, the runner 216 extends proximally into along the outer cylinder 213 and penetrates the valve Seat 126 cylindrical side wall formation side opening 126c and with the Chen Taikong 126b UNICOMs；The runner 216 extends distally to institute The distal portions of hollow sleeve 210 are stated, described sleeve pipe lip 220 is closed on.

Referring now to Figure 14-16, the air bag component 250 includes outer tube 260 and air bag lip 280 and intervenient gas Utricule 270.The pneumatophore 270 includes balloon proximal transition region 272 and air bag Distal transition area 276 and the gas extended therebetween Capsule main body 274.The air bag lip 280 includes air bag opening lip 289 and air bag transition lip 287 and the air bag skew wall extended therebetween 288, the air bag skew wall 288 limits the round taper hole 286 matched with the shape and size of described sleeve pipe skew wall 226.Institute Air bag transition lip 287 is stated proximally to be extended by distal end and be seamlessly connected and smooth transition with the air bag Distal transition area 276.Institute State outer tube 260 and include distal outer tube 268 and proximal outer tube 264 and the outer tube wall 266 extended therebetween, the distal outer tube 268 are seamlessly connected and smooth transition with the balloon proximal transition region 272, and the outer tube wall 266 is limited and the outer cylinder The adaptable cylindrical hole 265 of 213 shape and size, the proximal outer tube 264 limits outer tube opening 262.A kind of preferred side In case, the air bag lip 280 and pneumatophore 270 have substantially homogeneous wall thickness T_a3.In a kind of optional scheme, 0.05mm≤ T_a3≤ 0.1mm, pneumatophore is difficult to manufacture when the wall thickness of usual pneumatophore is less than 0.05mm and its insufficient strength easily ruptures Failure, and the wall thickness of pneumatophore be more than 0.1mm when largely add evacuate after mutually fold accumulation material thickness, compared with Big degree increases puncture force.

Referring now to Figure 16-17, the air bag component 250 is arranged on the outside of the hollow sleeve 210, wherein air bag lip 280 are coated on the outer surface of described sleeve pipe lip 220；The outer tube 260 is coated on the outside of the outer cylinder 213；The gas Capsule skew wall 288 matches to form taper fit 230 with described sleeve pipe skew wall 226.In a kind of implementation, with welding manner (or glue Water bonding way) annular completely enclosed taper seam region is formed between the air bag skew wall 288 and sleeve pipe skew wall 226 299, so that the air bag lip 280 and described sleeve pipe lip 220 are connected into an entirety.The distal outer tube 268 with it is described outer Cylinder 213 is welded or glue bonds together and not be bonded (welding) between the distal outer tube 268 and the runner 216, shape Into the seam region 297 non-fully closed.The outer tube wall 266 contacts with the outer cylinder 213 but does not fix or use glue Water is adhesively fixed.The outer surface of the proximal outer tube 264 and the outer cylinder 213 and valve seat 126 is bonded together into completely The near-end seam region 295 of closing.The then check valve assembly 140, runner 216, outer cylinder 213, air bag component 250, near-end Seam region 295 and the air bag cavity 290 of the composition closing of taper seam region 299.

Referring now to Figure 10, Figure 16, Figure 18 and 19, the check valve assembly 140 includes bonnet 141, one-way plug one 145, spring 146 and valve seat 126.The bonnet 141 includes running through its stomata 147, forms the inwall 144 of stomata 147, and outer wall 143. Inwall 144 and outer wall 143 the formation annular groove, and matched with the mounting hole 126a that valve seat 126 is limited, the mounting hole 126a With the side opening 126c UNICOMs.The outer wall 143 includes elastic arm 142, and the elastic arm 142 is distally provided with spacing hole The limited post 126d of 142a, its size and position and the outside of valve seat 126 matches.When installing check valve assembly 140, first will Spring 146 is put into valve seat 126, is then charged into one-way plug one 145 and is snapped into bonnet 140 on valve seat 126, elastic arm 142 becomes Limited post 126d is entered in spacing hole 142a after shape, and compression spring 146.Because the reaction force of spring 146 is by one-way plug one 145 push out and withstand the inwall 144 of bonnet 140, form sealing and fix.

In a kind of implementation, it is inflated or deflates via the check valve assembly 140 using standard syringe.With reference to Figure 18-19, wherein the stomata 147 be designed and sized to match with the shape and size of the sharp mouth of standard syringe.The gas The distal end in hole 147 includes conical bore 147b, and cone 145b of the one-way plug one 145 comprising the matching of taper therewith and to remote The planar wall 145a that end extension is formed.The planar wall 145a comprising air channel 145c and the cone 145b comprising a word or Cross air channel 145d.Under nature, the reaction force of spring 146 pushes out one-way plug one 145, the cone 145b with The conical bore 147b matches to form sealing, prevents the gas leak in air bag cavity 290.

The inflation that Figure 16-19 depicts air bag component 250 swells process.Specifically, syringe SY oral areas are inserted into institute In the stomata 147 for stating check valve assembly 140, and inwardly top opening one-way plug 145, then carry out gas injection.Gas passes through unidirectional The air channel 145c and air channel 145d of plug 145, then entered via the gap of the inwall 144 of bonnet 140 in valve seat 126, and pass through Heavy platform hole 126b, side opening 126c, runner 216 enters to be swollen within pneumatophore 270.Take out after syringe SY, spring 146 Bounce pushes out one-way plug one 145, and the cone 145b and conical bore 147b matches to form sealing, it is to avoid gas Leakage.

As depicted in figs. 20-23, thimble assembly 100 also includes external fixation kit 160, and the external fixation kit 160 is wrapped Include fixed pad 150 and latch fitting 155.The material of fixed pad 150 is that flexible material includes but is not limited to rubber, sponge etc..It is described Fixed pad 150 includes pad distal end 151 and pad near-end 153 and the air ring groove 152 extended therebetween, the hole of its distal end 154 through fixed pad 150, and its aperture is slightly smaller than the external diameter of outer tube 260, the outside of outer tube 260 can be nested into by swelling. Pad distal end 151 is close to around the otch of stomach wall, protects otch, it is to avoid the air pressure in stomach wall is leaked from incision site.The lock The material of part 155 includes plastic material (such as makrolon) or metal material (such as SUS301) with favorable elasticity and is made. The latch fitting 155 includes latch fitting body 156, and the handle 157 and position-limited edge 159 that the two ends of latch fitting body 156 are extended.The latch fitting Body 156 curls into latch fitting hole 158, the coupling mechanism force of the formation inward curl of latch fitting 155 by prefabricated.Latch fitting body 156 it is inside Crimp force staggeredly limits the handle 157 and position-limited edge 159 at the two ends of latch fitting body 156, and two handles 157 are staggered to form approximate V-type. By pinching two handles 157 of pressure or release, latch fitting hole 158 can be expanded or shunk.Such as Figure 22-24, latch fitting 155 is nested into The pad groove 152 of fixed pad 150, due to the coupling mechanism force of the formation inward curl of latch fitting 155, so under the release conditions of latch fitting 155, lock Part 155 locks fixed pad 150 and device to hole 154 produces internal enclasping force.

Referring now to Figure 23-24, thimble assembly 30 penetrates the passage for passing in and out body cavity after patient's stomach wall insertion body cavity as apparatus, It may need to use one or more thimble assemblies simultaneously in surgical procedure.When surgeon operates various apparatuses, such as nipper, Scissors, stapler etc. between operating theater instruments and thimble assembly 30 contact produce frictional force, these frictional force may result in sleeve pipe Component 30, if thimble assembly 30 is not fixed, may result in along stomach wall in vivo or to extracorporeal movement and skid off stomach wall Or be further inserted into chamber, therefore thimble assembly be firmly fixed on stomach wall it is just of crucial importance.Described sleeve pipe component 100 Pneumatophore 270 be in patient's body lumen inside and swollen, along the axially adjustable external fixation kit of thimble assembly 100 160 position causes the stomach wall to be stepped up between the pneumatophore 270 and external fixation kit 160, so that by the set Tube assembly 100 is firmly fixed on stomach wall, can prevent described sleeve pipe component 100 in vivo or to extracorporeal movement simultaneously.This The technical staff in field should it is contemplated that prior art such as US7300448, US7316699, US7691089, It is of the present invention to substitute that the fixed mechanism or clip disclosed in the patents of invention such as US8162893 can slightly do adaptation External fixation kit 160, other schemes are also what is be contemplated that.

Described sleeve pipe component 100 completes after assembling to load before final sterilization packaging, the pneumatophore of the air bag component 250 270 are evacuated or fold, and the airbag fold method disclosed in patent P692 can be used for the folding of pneumatophore 270.When described Thimble assembly 100 is completely penetrated through after patient's body wall, and the position of adjustment described sleeve pipe component 100, method as previously described is used Syringe SY swells the pneumatophore 270.Then adjusting external fixation kit 160 distinguishes pneumatophore 270 and fixed pad 150 Patient's body wall is clamped in the inner side and outer side of stomach wall, the fixation of thimble assembly 100 is realized.When operation is completed, it is necessary to take out set During tube assembly 100, it can push the one-way plug one 145 open using syringe SY valve and evacuate the gas in the pneumatophore 270 So that the pneumatophore 270, which reduces, is reset to original state.

With reference to background technology and the above associated description of the thimble assembly 50 of prior art, the wall thickness of the cylindrical wall 84 T₇, wherein 0.2mm≤T₇≤0.3mm；The wall thickness T of the pneumatophore 81₈, wherein 0.01mm≤T₈≤0.05mm；The transition region The wall thickness of 83 (82) is by T₇Fade to T₈.But when pneumatophore wall thickness is 0.01-0.05mm, generally cause the manufacture of pneumatophore Become very complicated and be difficult to control to, or be expressed as strict wall thickness accuracy control to add manufacturing cost.Gas described in use Utricule 81 is born compared with atmospheric pressure (about 25Psi~30Psi), and pneumatophore 81 is designed to the wall thickness about air bag of thin-walled and cylindrical wall 84 10 times of body wall thickness, this design is analyzed in terms of structural strength and seems unreasonable.And blown using patent P692 disclosure stretchings Mould legal system gas making capsule, it is difficult to the transitional region formation even structure of wall unevenness in air bag avoided.The distal outer tube 89 is with The wall thickness of blank pipe portion 88 is thicker, the uneven thickness of the transition region 83 (82), largely adds mutual folded stack after evacuation Long-pending material thickness, largely increases puncture force.In addition, the sleeve pipe lip 60 of described sleeve pipe component 50 causes thimble assembly Transition between puncture needle is uneven so as to further increase puncture force.Therefore, disclosure up to the present and The commercialized thimble assembly containing air bag is generally not used in Direct perforantes method.

And the thimble assembly 100 of present disclosure has and prior art is disclosed is used for Direct perforantes without air bag Thimble assembly substantially equivalent sleeve pipe lip 220；The air bag component 250 include with described sleeve pipe lip 220 match it is inclined Air bag lip 280；And the air bag lip 280 is fixed so as to reduce cooperation position using welding (or Nian Jie) with described sleeve pipe lip 220 The size mutation put.In addition, the air bag lip 280 of air bag component 250 of the present invention and the wall thickness Ta3 of pneumatophore 250 are substantially equal Even and 0.05mm≤T_a3≤ 0.1mm, strengthens the intensity of air bag and reduces wall thickness control difficulty, while it is thick to reduce material The deformation force of transitional region caused by degree is uneven, so that thimble assembly of the present invention 100 can be used for Direct perforantes Method.Certainly, thimble assembly 100 of the present invention can be used in Hasson methods.

When fixing the air bag lip 280 and sleeve pipe lip 220 using glue bonding way, bio-compatibility requirement is preferably conformed to Ultraviolet cured adhesive.Ultraviolet cured adhesive curing rate is fast, and cementability is strong, and relatively thin glue layer is that can reach ideal Fixing intensity so that reduce bonding location size mutation.But also can be according to the material different choice of sleeve pipe and pneumatophore Other glue be adapted therewith and meeting bio-compatibility requirement, such as epoxy resin, polyester glue etc..Using welding side When formula fixes the air bag lip 280 and sleeve pipe lip 220, specific welding method has many types, including but not limited to thermal compression welding, Ultrasonic bonding, high-frequency welding, radiation welding, pulse welding etc..Relative to glue bonding way, welding manner is more excellent.Welding Mode causes the air bag lip 280 and sleeve pipe lip 220 connect reliable and transition smooth (after being trimmed to the residual side of welding very Seamless smoothly transit extremely can be achieved), and the wall thickness of the new sleeve pipe lip of welding manner formation is less than the air bag lip 280 and set The wall thickness sum of pipe lip 220.

Those skilled in the art is it should be appreciated that the air bag skew wall 288 matches formation with described sleeve pipe skew wall 226 Taper fit 230 is most important, is conducive to improving air bag lip 280 and packaging efficiency when sleeve pipe lip 220 interfixes and fixation Fastness.Especially for being welded and fixed, when the taper fit 230 ensures welding can along thimble assembly axial folding soldering tip And support fixture, therefore can disposably weld the taper seam region 299 described in being formed.Rather than to be welded in the case of taper fit The closure seam to form annular is connect it is generally necessary to multiple welding, and multiple welding easily causes that pneumatophore is local unexpected thinning to be produced Root cuts failure.

Figure 25-26 depicts the air bag component 350 of another embodiment.The air bag component 350 includes the He of axis 301 Along axis, outer tube 260 and air bag lip 280 and intervenient pneumatophore 370 are set.I.e. described air bag component 350 with it is described Air bag component 250 is compared, and in addition to pneumatophore is different, other structures are substantially equivalent.Finer, the pneumatophore 370 is included Balloon proximal transition region 372 and air bag Distal transition area 376 and the air bag main body 374 extended therebetween.The air bag lip 280 is wrapped Lip containing air bag opening 289 and air bag transition lip 287 and the air bag skew wall 288 extended therebetween.The air bag transition lip 287 is by remote End proximally extension and with the seamless link of air bag Distal transition area 376 and smooth transition.Including for the outer tube 260 is outer Pipe distal end 268 and proximal outer tube 264 and the outer tube wall 266 extended therebetween, the distal outer tube 268 and the balloon proximal mistake Area 372 is crossed to be seamlessly connected and smooth transition.In a kind of optional scheme, the air bag lip 280 and pneumatophore 370 have substantially equal Even wall thickness T_a4, and 0.05mm≤T_a4≤0.1mm。

Figure 26 depicts the projection view that the Formation cross-section of air bag component 350 is cut by the arbitrary section of axis 301. In a kind of preferred scheme, in the section shown in Figure 26, the air bag Distal transition area 376 has gas relative to axis 301 Capsule transition angle A_d；The balloon proximal transition region 372 has air bag transition angle A relative to axis 301_p, and A_d＜ A_p.With reference to figure 26, in another optional implementation, the air bag Distal transition area 376 has the continuous laterally gradually approximate circle of indent Arc shape, the air bag transition angle A_dWith unlimited air bag transition angle A_dx.In a kind of finer design, the transition Angle A_dxProximally gradually increased by distal end, and closer to the transition angle A of air bag main body 374_dxIncreased speed is bigger. Those skilled in the art is to be understood that this proximally the smooth Transition Design gradually increased reduces shape by distal end The mutation of shape and size, forms the air bag lip and pneumatophore of overall uniform wall thickness, is conducive to more entering one when being conducive to blowing to manufacture The reduction puncture force of step.

As described in background, prior art and commercialized tube assembly containing Air sac cover are up to the present disclosed, generally It is simply possible to use in the puncture of Hasson methods.Tube assembly containing Air sac cover is mentioned in a small number of documents to can also be used in Direct perforantes method, but simultaneously The airbag casing pipe component applied suitable for Direct perforantes method is not disclosed.Those skilled in the art is to be understood that described Hasson methods generally cut the body wall of patient's abdomen wall puncture position to form big otch in puncturing, the big otch and described sleeve pipe There is usually no or only exist the package power of very little between the sleeve pipe of component, for realize between described sleeve pipe component and big otch can By sealing, it usually needs the larger air bag of design.The airbag casing pipe component for example having been commercialized at present, defining its sleeve outer is D, the maximum outside diameter after its air bag swells is usually 2.0D~2.2D.And during direct method is punctured, generally only by patient's abdomen wall puncture The epiderm skin of position cuts to form small otch, and then supporting puncture needle pierces through patient through thimble assembly through thus small otch Body wall.Direct method punctures the puncture channel to be formed, and there is certain package power between its thimble assembly and patient muscle tissue With reliable sealing, it is not necessary to realize the sealing between sleeve pipe and patient muscle by the air bag swollen.

In another aspect of the present invention, a kind of thimble assembly 300 containing air bag for being exclusively used in Direct perforantes method is proposed.Institute The structure and composition for stating thimble assembly 300 and described sleeve pipe component 100 is substantially equivalent, more precisely, uses the air bag component 350, which substitute the air bag component 250, constitutes thimble assembly 300 of the present invention.With reference to Figure 26, the air bag component 350 Outer tube 260 has outer diameter D_t, the pneumatophore 370 swell after have maximum outside diameter D_b, wherein 1.5D_t≤D_b≤1.7D_t.For example A kind of thimble assembly 300 of 12mm specifications, the external diameter of its outer tube is 15.0mm, and the external diameter after its pneumatophore swells is set to 22.5mm≤D_b≤25.5mm.Usual Db ＜ 22.5mm are easily caused fixed force not enough, and D_b＞ 25.5mm are easily caused air bag and taken out The material being stacked with after sky is excessive and increases penetration Resistance.And be used for the 12mm specifications of Hasson methods airbag casing pipe component its Maximum outside diameter after air bag swells is usually 30mm~34mm.Maximum outside diameter D after pneumatophore 370 swells_b, 1.5D_t≤D_b≤ 1.7D_tWhen, it is usually not used in Hasson methods, because less air bag typically results in fixed force deficiency and gas leak phenomenon.This The technical staff in field should be it is contemplated that comprehensively utilize good transition between puncture needle of the present invention and sleeve pipe lip, gas Taper fit between capsule lip and sleeve pipe lip, the air bag lip and pneumatophore of uniform thickness, the air bag proximally gradually increased by distal end Body, and rational pneumatophore size setting etc., relatively small puncture force can be obtained so that tube assembly containing Air sac cover can be used for In Direct perforantes method, so that described sleeve pipe component is more firmly fixed on body wall.

Those skilled in the art is to be understood that the stretch-blow method disclosed in patent P692 typically results in pneumatophore Wall unevenness with the body being attached thereto is even, it is impossible to or be difficult to produce the substantially homogeneous air bag of wall thickness of the present invention Lip and pneumatophore.In one aspect of the invention, propose that improved note blows the method that method manufactures the air bag component 250 (350). More precisely, traditional note blows method and generally uses to automate continuously to note and blows, i.e., be first molded and pre- inflation parison, then rapidly certainly The dynamic inflation that switches in blow mold is to design size.And improved two steps note of the present invention is blown method and blown using discontinuous note Mode manufactures the air bag component 250 (350), and its key step is as follows：

S1：Injecting preform, needs rational design parison injection mould according to product design first and uses injection machine injecting preform；

S2：Cool down and trim the mouth of a river and obtain hardening parison；

S3：Hardening parison is put into final products blow mold, blow molding after heating and softening；

S4：Trimming removes excess stock and obtains the air bag component.

Plastic material can substantially be divided into four classes, hard plastic (hardness by its hardness (shore hardness hardness) difference >=86D), medium hard plastic (83D >=hardness >=65D), semirigid plastic (98A >=hardness >=90A), soft plastics (86A≥hardness≥10A).The hardness of material can be measured by ASTMD 2240-97 relevant regulations.Current disclosed document With the airbag casing pipe component having been commercialized, its air bag generally by hard plastic material (for examplePolyester,Poly- second Alkene) blowing form.Semi-rigid or soft thermoplastic elastomer (TPE) (abbreviation TPE), its typical material includes polyurethane elastomer (letter Claim TPU), thermoplastic polyester elastomer (abbreviation TPEE), thermoplastic elastomer (abbreviation TPR) etc..The gas is manufactured using TPE material Capsule component 250 (350), because TPE material has enough intensity and good compliance, is conducive to further reduction to puncture Resistance.Mobility yet with TPE material is relatively low and more difficult blowing.Especially for air bag component 250 of the present invention (350) due to the outer tube 260 comprising extension and the pneumatophore 270 swollen, its draw ratio is typically larger than 10/1, current research Or extremely difficult wall thickness of the present invention basic impartial pneumatophore and air bag can not be made when showing to be blow molded using TPE material Lip.Even if being blow molded all this kind of draw ratios of air bag component as described 250 (350) using duroplasts is more than 10/1, and wall thickness is less than etc. It is also highly difficult in 0.1mm part.

In an additional aspect of the present invention, a kind of air bag component 450 for being easy to manufacture of optimization is proposed.The air bag component 450 is substantially equivalent with the shape and size of the air bag component 350.Briefly, it is the air bag component 350 is remote from its outer tube Cut-out is held at 268 to be divided into Part I 350a and Part II 350b, then by the Part I 350a and Part II 350b Welding or bonding are linked to be overall air bag component 450.Finer with reference to Figure 27-29, the Part I 350a includes air bag Lip 280 and the pneumatophore 370 being attached thereto.The pneumatophore 370 includes balloon proximal transition region 372 and air bag Distal transition Area 376 and the air bag main body 374 extended therebetween, the balloon proximal transition region 372, which proximally extends, to be formed balloon proximal and opens Mouth 371.The air bag lip 280 includes air bag opening lip 289 and air bag transition lip 287 and the air bag skew wall 288 extended therebetween, The air bag skew wall 288 limits round taper hole 286.The air bag transition lip 287 by distal end proximally extension and with the gas Capsule Distal transition area 376 is seamlessly connected and smooth transition.The Part II 350b includes distal outer tube 468 and proximal outer tube 464 and the outer tube wall 466 that extends therebetween, the outer tube wall 466 limits cylindrical hole 465, and the proximal outer tube 464 is limited Outer tube opening 462.Referring now to Figure 28-29, the distal outer tube 468 is overlapped on the outside of the balloon proximal opening 371, and adopts It is bonded with welding or glue and is formed seam region 491, so that the Part I 350a and Part II 350b is linked to be into entirety Air bag component 450.

In an additional aspect of the present invention, a kind of manufacture method of the air bag component 450 is proposed, it is main to include blowing and repair Cut process, extrusion molding and trimming process, welding sequence or bonding process.

Blowing and trimming process：Method blowing is blown using previously described improved two step note to manufacture and trim acquisition described the A part of 350a.

Extrusion molding and cutting process：The Part II 350b is manufactured using extrusion process and trimmed to suitably sized.

Welding sequence or bonding process：The distal outer tube 468 is overlapped on the outside of the balloon proximal opening 371 (so And can also be overlapped on inside it), and be bonded to form seam region 491 using welding or glue.

One those skilled in the art is it is contemplated that the air bag component 450 is relative to the air bag component 350, increase Form the welding sequence or bonding process of seam region 491, however the air bag component 450 split into Part I 350a and After Part II 350b, contribute in optimization product function and ensure to improve production efficiency on the basis of product quality.This reality Because the Part I 350a does not include the outer tube of extension in example, its draw ratio is decreased to less than being equal to 3/1, so that larger The difficulty for reducing blowing of degree.And the Part II 350b is produced using extrusion process, its production equipment is simple, production Efficiency is very high, therefore the production cost of the Part II 350b is very low.Comprehensive consideration, although add to form the seam 491 welding sequence or bonding process, but overall production cost is not significantly increased, while ensuring that TPE materials can be used Material produces the air bag lip and pneumatophore with generally uniform wall thickness of softness.

Figure 30-32 depicts the lower warehouse 123a of an alternative embodiment of the invention, the lower warehouse 123a with it is described under The structure and composition of warehouse 123 is substantially equivalent, and the lower warehouse 123a and the lower warehouse 123 main distinction are air bag group Part is different with runner generation type.Finer with reference to Figure 30, the lower warehouse 123 is comprising lower case 124 and is attached thereto And the hollow sleeve 210 extended to distal end, air bag component 450 and check valve assembly 140.The hollow sleeve 210, which is included, to be had Internal diameter Di inner cylinder 211 and the outer cylinder 213 with outer diameter D o and thickness therebetween are Ta1 casing walls 212；It is described hollow The distal end of sleeve pipe 210 is also comprising open sleeve pipe lip 220, and described sleeve pipe lip 220 includes opening lip 229 and transition lip 228 Inclination cylinder 227 therebetween, the inner cylinder 211 and inclination cylinder 227 limit sleeve pipe skew wall 226.The hollow sleeve 210 Proximal location include valve seat 126 to install check valve assembly 140, the valve seat 126 is comprising extending transversely through valve seat wall portion The side opening 126c divided.Compared with the lower warehouse 123, there is no the runner of depression on the outer cylinder 213 of the lower warehouse 123a 216, so as on the premise of the intensity for ensureing hollow sleeve 210 is enough, using relatively thinner casing wall 212, so as to more enter The reduction outer diameter D o of one step.

Now with continued reference to Figure 31-32, the air bag component 450 is arranged on the hollow sleeve 210 of the lower warehouse 123a Outside, wherein air bag lip 280 are coated on the outer surface of described sleeve pipe lip 220；The outer tube 260 is coated on the outer cylinder 213 outside.The air bag skew wall 288 is matched with described sleeve pipe skew wall 226, and with welding manner in the air bag skew wall 288 Completely enclosed taper seam region 499 is formed between sleeve pipe skew wall 226, so that by the air bag lip 280 and described sleeve pipe Lip 220 connects into an entirety.The outer surface of the proximal outer tube 464 and the outer cylinder 213 and valve seat 126 bonds together Form completely enclosed near-end seam region 495.The proximal openings 371 are welded with the outer cylinder 213 or glue is bonded in The seam region 497 non-fully closed is formed together.Not be bonded or shape between the outer tube wall 466 and the outer cylinder 213 Into the bonding non-fully closed, the runner 216a (not shown) of UNICOM's pneumatophore 370 is reserved, i.e., with outer tube wall 466 and column jacket Gap between face 213 substitutes foregoing runner 216.To sum up, the check valve assembly 140, runner 216a, outer cylinder 213, air bag The air bag cavity 490 of component 450, near-end seam region 495 and the composition closing of taper seam region 499.This area one is common Technical staff be readily apparent that, when the thimble assembly containing air bag penetrates patient's stomach wall, when being packed tightly by patient muscle, muscle gives institute Stating the package power of outer tube wall 466 may cause the gap of outer tube wall 466 and the outer cylinder 213 to reduce or even block, so as to hinder Break the runner 216a.The consideration for preventing that runner from blocking is potentially based on, its casing wall of the thimble assembly of patent P692 disclosures is gone back There is the runner of depression.But under normal circumstances, blocking the situation of the runner 216a will not occur.Up to the present, generally adopt Inflated for deflated to air bag cavity 490 with ordinary syringe, syringe is 25Psi to the inner gas pressure of the air bag cavity 490 ~30Psi, muscle can not block the runner 216a for the package power of outer tube wall 466.

The many different embodiments and example of the present invention are had shown and described.One ordinary skill of this area Personnel, without departing from the scope of the invention, adaptive improvement can be made by suitably modified to methods described and apparatus. Such as Figure 31-32 depicts the situation that air bag lip opening lip 289 and opening lip 229 are not lined up in axis direction.For example it is described Part I 350a and Part II 350b is assembled into the hollow sleeve again after need not being bonded or being welded into advance an entirety 280 outside, as long as the balloon proximal opening 371, distal outer tube 468 and the outer cylinder 213 form runner and except runner Outside other regions completely enclose, and kinds of processes is that can be achieved.Several kinds of amendment schemes are referred, for For those skilled in the art, other amendment schemes are also what is be contemplated that.Therefore the scope of the present invention should be according to additional Claim, while being understood not to the particular content of the structure for being shown and being recorded by specification and accompanying drawing, material or behavior Limited.

Claims

1. a kind of improved thimble assembly containing air bag, includes the first seal assembly and the second seal assembly, second sealing Component includes lower case and hollow sleeve that is coupled and extending to distal end, first seal assembly, and second is close Sealing assembly and hollow sleeve include UNICOM and substantially aligned instrument channel, it is characterised in that：

1) casing wall of the hollow sleeve comprising inner cylinder and outer cylinder and therebetween；The distal end of the hollow sleeve is also included Open sleeve pipe lip, described sleeve pipe lip includes inclination cylinder opening lip and transition lip therebetween, the inner cylinder and inclination Cylinder limits sleeve pipe skew wall；

2) described sleeve pipe component also includes the inflatable air bag component swollen, to the check valve assembly of inflation/deflation and by described in Air bag component and the gas channel of check valve assembly UNICOM；

3) air bag component includes air bag lip and the pneumatophore that is attached thereto, the air bag lip to distal end extension formed with it is described The air bag skew wall that the shape and size of sleeve pipe skew wall match；The air bag lip proximally extends to be connected and suitable with the pneumatophore Slip over and cross；

4) air bag component is arranged on the outside of the hollow sleeve, and the air bag lip is coated on the appearance of described sleeve pipe lip Face, air bag skew wall and sleeve pipe skew wall the formation taper fit；And fixation forms ring between the air bag skew wall and sleeve pipe skew wall The completely enclosed taper seam region of shape by the air bag lip and sleeve pipe lip so that connect into an entirety.

2. thimble assembly as claimed in claim 1, it is characterised in that：The air bag lip and pneumatophore have uniform wall thickness T_a3, and 0.05mm≤T_a3≤0.1mm。

3. thimble assembly as claimed in claim 1, it is characterised in that：The pneumatophore includes balloon proximal transition region, air bag Distal transition area and the air bag main body extended between the two, the air bag lip are seamlessly connected simultaneously with the air bag Distal transition area Smooth transition, the air bag component also includes outer tube, and the outer tube is comprising distal outer tube and proximal outer tube and prolongs therebetween The outer tube wall stretched, the distal outer tube is seamlessly connected that to form an overall or described outer tube remote with the balloon proximal transition region End is constituted with the balloon proximal transition region to be connected seam to form an entirety.

4. thimble assembly as claimed in claim 1, it is characterised in that：The outer tube has outer diameter D_t, the pneumatophore swells There is maximum outside diameter D afterwards_b, wherein 1.5D_t≤D_b≤1.7D_t。

5. thimble assembly as claimed in claim 3, it is characterised in that：The air bag Distal transition area has gas relative to axis Capsule transition angle A_d；The balloon proximal transition region has air bag transition angle A relative to axis_p, and A_d＜ A_p。

6. thimble assembly as claimed in claim 5, it is characterised in that：The air bag Distal transition area have it is continuous laterally by Gradually interior concave circular arc shape, the air bag transition angle A_dWith multiple air bag transition angle A_dx, the transition angle A_dxBy distal end proximally Gradually increase, and closer to the transition angle A of air bag main body_dxIncreased speed is bigger.

7. thimble assembly as claimed in claim 3, it is characterised in that：The distal outer tube is non-fully closed with outer cylinder formation Seam region, and the outer surface of the valve seat of the proximal outer tube and the outer cylinder and check valve assembly is fixed to form complete envelope The near-end seam region closed, forms the air-flow of air bag component and check valve assembly described in UNICOM between the outer tube and outer cylinder Passage.

8. thimble assembly as claimed in claim 1, it is characterised in that：Fixed form between the air bag skew wall and sleeve pipe skew wall Include welding manner or glue bonding way.

9. thimble assembly as claimed in claim 1, it is characterised in that：The angle tilted between cylinder and the inner cylinder A_lip, wherein 3 °≤A_lip≤15°。

10. the manufacture method of air bag component as claimed in claim 3, it is characterised in that：The air bag component is included outside it Part I and Part II that the cut-out of pipe far-end is divided into, the balloon proximal transition region proximally extend to form balloon proximal Opening, its key step is as follows：