CN109864808A

CN109864808A - A kind of improved sheath assembly containing air bag

Info

Publication number: CN109864808A
Application number: CN201910288421.1A
Authority: CN
Inventors: 朱莫恕
Original assignee: Chengdu Five Medical Technology Co Ltd
Current assignee: Chengdu Wuyi Medical Equipment Co., Ltd
Priority date: 2017-06-03
Filing date: 2017-06-03
Publication date: 2019-06-11
Anticipated expiration: 2037-06-03
Also published as: WO2018219312A1; CN109864808B; CN107049437B; CN107049437A

Abstract

The invention discloses a kind of improved sheath assemblies 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 connection 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 also includes open casing lip, and described sleeve pipe lip includes the inclination cylinder of opening lip and transition lip therebetween, and the inner cylinder and inclination cylinder limit casing skew wall；Described sleeve pipe component also includes the inflatable air bag component to swell, and the air bag body includes balloon proximal transition region, air bag Distal transition area and the air bag main body extended between the two, and air bag Distal transition area has continuous lateral gradually interior concave circular arc shape；Air bag skew wall and casing skew wall form taper fit.

Description

A kind of improved sheath assembly containing air bag

The application is title are as follows: a kind of improved sheath assembly containing air bag, the applying date are as follows: 06 month 2017 03 day, application number Are as follows: the divisional application of 201710410213.5 application for a patent for invention.

Technical field

The present invention relates to Minimally Invasive Surgery instrument more particularly to a kind of puncture outfits containing air bag.

Background technique

Puncture outfit is (especially laparoscopic surgery) in a kind of Minimally Invasive Surgery, for establishing the artificial channel for entering body cavity Surgical instrument is usually made of sheath assembly and puncture needle.Its clinical general usage mode are as follows: first cut on patient skin Osculum, then puncture needle is run through into sheath assembly, however penetrate stomach wall through skin opening together and enter body cavity.Once into body cavity Puncture needle is removed afterwards, leaves channel of the sheath assembly as instrument disengaging body cavity.

In hard tube endoscope-assistant surgery, especially in laparoscopic surgery, the pneumoperitoneum apparatus perfusion lasting to abdominal cavity of patients is generallyd use Gas (such as carbon dioxide gas) simultaneously maintains stable air pressure (about 13~15mmHg), empty to obtain enough surgical procedures Between.For sheath assembly usually by casing, shell seals film (also known as instrument seal) and zero sealing (also known as automatic-sealed) composition.Institute It states casing to penetrate outside body cavity to body cavity, the channel as instrument disengaging body cavity.The shell is by casing, zero sealing and seals Film connects into a sealing system.Zero sealing is generally not provided the sealing for insertion instrument, and certainly when instrument is removed It is dynamic to close and form sealing.The sealing film banding instrument and forms sealing when instrument is inserted into.

Laparoscopic surgery is broadly divided into two kinds into abdomen technology at present: open (Hasson method) and closed (Veress The skill of handling needles).Wherein Hasson method is mainly used for the patient there may be adhesion of abdominal wall.Hasson method usually first along navel upper limb or Lower edge does 2cm notch, and notch runs through entire stomach wall, then protrudes into finger through thus notch and detect, separation abdominal wall and nethike embrane or The adhesion of intestinal tube；Then it is inserted into Hasson cannula system under direct-view, and injects dioxy to abdominal cavity of patients via Hasson casing Change carbon gas and forms pneumoperitoneum.Closed method is also known as Direct perforantes method, i.e., the epidermis of patient's puncture position stomach wall is only made small cut Mouthful, puncture needle is then run through into sheath assembly again, stomach wall is penetrated through thus small notch and enters body cavity.

Current disclosed Hasson cannula system is broadly divided into three classes, the first kind, such as U.S. patent Nos A kind of sheath assembly containing hinge arrangement that US5203773 is disclosed is swollen fixation by hinge rotation, due to easily leaking by Gradually abandoned.Second class, for example, U.S. patent Nos US5257973 disclose taper fixing piece and common group of smooth sheath assembly At Hassan cannula system, Tapered Cup suture is fixed in notch first, then smooth sheath assembly is fixed on the cone It in shape fixing piece, is widely applied because its is low in cost, but it is relative complex and cause secondary injury to patient using operating. The tube assembly containing Air sac cover disclosed in third class, such as U.S. patent Nos US5468248, US6908454, US8888692, institute It states air bag the inflation of syringe selectivity can be used and swell sheath assembly is fixed on patient's stomach wall, release of deflating reduces air bag just In sheath assembly via patient skin incision into and out.Sheath 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 Structure is complicated and higher cost, expensive.

The airbag casing pipe component is generally only used for Hasson method field, up to the present, has disclosed and has had been commercialized Airbag casing pipe component is cannot be used for substantially in Direct perforantes method.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 are the biggish risks for puncturing patient's body organ.And relative to Sheath assembly without air bag, the airbag casing pipe component liked due to the fixation on patient's stomach wall is more reliable by doctor because of it, However the puncture force of the tube assembly containing Air sac cover is larger limits the airbag casing pipe component in the application in Direct perforantes method field, and And up to the present disclosed and airbag casing pipe component that is having been commercialized, the not yet larger problem of adequate solution puncture force.

Summary of the invention

In order to solve one or more technical problems in background technique, the present invention proposes a kind of improved set containing air bag Tube assembly, include the first seal assembly and the second seal assembly, second seal assembly include lower case and with its phase Connect and to the hollow sleeve that distal end extends, first seal assembly, the second seal assembly and hollow sleeve include connection simultaneously 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 also includes open casing lip, and described sleeve pipe lip includes the inclination cylinder of opening lip and transition lip therebetween, institute It states inner cylinder and inclination cylinder limits casing skew wall；Described sleeve pipe component also includes the inflatable air bag component to swell, to The check valve assembly of inflation/deflation and by the airflow channel of the air bag component and check valve assembly connection；The air bag component packet Lip containing air bag and the air bag body being attached thereto, the air bag lip is to the shape and size distally extended to form with described sleeve pipe skew wall The air bag skew wall to match；The air bag lip, which proximally extends, connect simultaneously smooth transition with the air bag body；The air bag body packet The area of Proximal transition containing air bag, air bag Distal transition area and the air bag main body extended between the two, air bag Distal transition area With continuous transverse direction gradually in concave circular arc shape；The air bag component is mounted on the outside of the hollow sleeve, the air bag Lip is coated on the outer surface of described sleeve pipe lip, and the air bag skew wall and casing skew wall form taper fit；And the air bag skew wall The fixed completely enclosed taper seam region for forming annular is between casing skew wall to connect the air bag lip and casing lip It is connected into an entirety.

A kind of optional technical solution, air bag transition angle Ad have multiple air bag transition angle Adx, the transition angle Adx is by being distally proximally gradually increased, and the increased rate of transition angle Adx of closer air bag main body is bigger, described The gentle utricule of air bag lip has uniform wall thickness T_a3, and 0.05mm≤T_a3≤0.1mm。

A kind of optional technical solution, the air bag body include balloon proximal transition region, air bag Distal transition area and two The air bag main body extended between person, the air bag lip and the seamless connection of air bag Distal transition area and smooth transition, the gas 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 form the whole or described distal outer tube close with the air bag with the balloon proximal transition region Transition region is held to constitute connection seam to form an entirety.

A kind of optional technical solution, the outer tube have outer diameter D_t, the air bag cubical expansion is greatly afterwards with maximum outside diameter D_b, wherein 1.5D_t≤D_b≤1.7D_t。

A kind of optional technical solution, air bag Distal transition area have 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 solution, the distal outer tube and the non-fully closed seam region of outer cylinder formation, and institute The outer surface fixation for stating the valve seat of proximal outer tube and the outer cylinder and check valve assembly forms completely enclosed proximal end seaming zone Domain forms the airflow channel of air bag component and check valve assembly described in connection between the outer tube and outer cylinder.

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

A kind of optional technical solution, 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 the manufacturing method of air bag component described in one kind, wherein the air bag component Proximally extend shape comprising cutting off the first part being divided into and second part, the balloon proximal transition region from its distal outer tube It is open at balloon proximal, key step is as follows:

It is blow molded and trims process: method blow molding manufacture is blown using improved two step note and trim the acquisition first part；

Extrusion molding and cutting process: the second part is manufactured using extrusion process and is 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 it is bonded to form seam region using welding or glue.

A kind of optional technical solution, the improved two steps note blow method and manufacture the air bag group using the discontinuous note mode of blowing Part, key step are as follows:

S1: injecting preform needs reasonable design parison injection mould according to product design first and uses injection molding machine injecting preform；

S2: cooling simultaneously trims mouth of a river acquisition 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.

Detailed description of the invention

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

Fig. 1 is the stereoscopic schematic diagram of prior art puncture outfit 5；

Fig. 2 is the partial enlargement diagram of the distal portions of puncture outfit 5 shown in Fig. 1；

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

Fig. 4 is the stereoscopic schematic diagram of prior art puncture outfit 7；

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

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

Fig. 7 is the partial enlargement diagram of the distal portions of puncture outfit 7 shown in Fig. 4；

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

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

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

Figure 11 is the stereoscopic schematic diagram of lower warehouse 123 shown in Fig. 10；

Figure 12 is the axial sectional view of 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 air bag component 250 described in Figure 10；

Figure 15 is the enlarged drawing of 250 distal portions partial sectional view of air bag component 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 enlarged view of the distal portions of component 120 shown in Figure 16；

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

Figure 19 is 19-19 cross-sectional view 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 fixing sleeve component shown in Figure 20；

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

Figure 23 is the stereoscopic schematic diagram of the sheath assembly 100 of the outer fixation kit of occlusion body；

Figure 24 is the clinical application simulated view of sheath assembly 100 shown in Figure 23；

Figure 25 is the stereoscopic schematic diagram 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 stereoscopic schematic diagram (not installing air bag) of warehouse 123a under another embodiment；

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

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

In all views, identical label indicates equivalent part or component.

Specific 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 restrictive, and It is the basis only as claim, and how uses basis of the invention as introduction those skilled in the art.For convenience Statement, the side of subsequent all Proximity operation persons are defined as proximal end, and the side far from operator is defined as distal end, all along puncture shank The axis direction in portion or the casing axis direction of sheath assembly are defined as axial direction, and substantially vertical axial direction definition is laterally.

Those skilled in the art is to be understood that puncture outfit generally comprises sheath assembly and puncture needle.Sheath assembly Generally include instrument seal, zero sealing and hollow sleeve.Such as be hereby incorporated CN201610630336.5, i.e., it is entitled " a kind of puncture outfit sealing system of fold-type ", the sheath assembly disclosed in the Chinese invention application submitted in August 2nd in 2016. Puncture needle generally includes handle portion, bar part and distal portions.Such as be hereby incorporated CN201611125444.3, i.e. invention name Referred to as " improvement without knife visual puncturing needle ", 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 10,30 He of sheath assembly Axis 6.The puncture needle 10 includes handle portion 11 and visual head 13 and the bar part 12 extended therebetween.From distal end to close End, the visual head 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 shape and size of the tip portion and lance type part are relatively tiny sharp, work as institute It is main to play puncture and centrifugation during stating in the piercing patient muscle of puncture needle 10 or tissue.And lance type part 18, Connection between transition portion 17 and foundation 16 is usually fairshaped smooth transition, in favor of the wound that squeezes and swell And reduce puncture force.Meanwhile the foundation 16 also includes to match with the hole size of the casing 32 of sheath assembly 30 Column part 15, so that puncture needle and sheath assembly form smooth transition, be conducive to reduce described sleeve pipe component 30 squeeze and Swell the required puncture force of wound.

- 3 are continued to refer to figure 1, described sleeve pipe component 30 includes seal assembly 31 and casing lip 40 and extends therebetween Hollow sleeve 33.Described sleeve pipe 33 includes to have interior diameter D₁Inner cylinder 35 and have overall diameter D₂Outer cylinder 34 and its Between shroud wall segments 36.A kind of sheath assembly 30 of 12mm specification, wherein D₁=12.8mm, D₂=14.6mm.Described sleeve pipe lip The 40 inclination cylinder 48 comprising opening lip 49 and transition lip 47 therebetween, the inner cylinder 35 and inclination cylinder 48 limit and incline 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 by distally proximally gradually increasing, The increased rate of usual wall thickness is smaller, so that the transition between puncture needle 10 and sheath assembly 30 is more smooth.Now referring primarily to Fig. 3, in a kind of typical design scheme, 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°；The inclined wall part 46 along axis direction length L₁, 6mm≤ L₁≤12mm。

In the airbag casing pipe component for having disclosed or having had been commercialized, such as US5468248 and US6908454 disclosure includes bullet Property material air bag sheath assembly, generally use bilayer sleeve and be aided with glue bonding mode fixation balloon, casing lip mistake It crosses not smooth, is usually not used for Direct perforantes method field.Such as US8888692 (abbreviation P692) disclose containing non-resilient The sheath assembly of material air bag has smaller outer diameter, facilitates the puncture force for reducing the puncture process.It is hereby incorporated simultaneously base In the airbag casing pipe component that patent P692 is disclosed.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 with being attached thereto and the casing 53 towards distally extending, described sleeve pipe 53 are wrapped Containing inner sleeve 54 and outer tube 55.Referring now to Fig. 5, the inner sleeve 54 is comprising casing lip 60 and connects itself and the seal assembly 51 hollow pipe portion 56.The hollow pipe portion 56 includes to have interior diameter D₁Inner cylinder 61 and have overall diameter D₄Outer cylinder 63 and shroud wall segments 62 therebetween.Described sleeve pipe lip 60 includes the inclination cylinder of 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 includes 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 62c three parts.The close region of the hollow pipe portion 56 and 51 link position of seal assembly includes check valve assembly 52, stream Road 58 extends along described sleeve pipe wall part 62 and by the groove 70 and 52 connection of check valve assembly.With continued reference to Fig. 5, In a kind of typical design scheme, the inclined wall part 66 is T in the wall thickness of opening lip position₃, in transition lip position Wall thickness be T₄, the wall thickness T of described sleeve pipe groove walls 62b₅, wherein 0.1mm≤T₃≤ 0.3mm, 1.15mm≤T₄≤ 1.25mm, 0.6mm≤T₅≤0.8mm.Included angle A between the inclination cylinder 68 and the inner cylinder 61₄, 25 °≤A₄It is≤45 °, described to incline Inclined wall part 66 along axis direction length L₄, 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 The close region of distal outer tube 89 is arranged in capsule 80, wherein the air bag 80 includes air bag body 81, and from air bag body 81 to remote The air bag Distal transition area 83 that end extends and connect with described sleeve pipe distal end 89；And proximally extended by air bag body 81 and with institute State the balloon proximal transition region 82 that hollow pipe portion 88 connects.The air bag distal end 89 is D comprising interior diameter₇, overall diameter D₈, wall Thickness is T₇Cylindrical wall 84.The wall thickness T of the air bag body 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 scheme 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 55 remote location of the inner sleeve 54 and outer tube.Wherein the outer tube is remote End 89 and air bag 80 are mounted 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, air bag Distal transition area 83 and outer Pipe distal end 89 is fixed at groove 70 and is aided with glue sealing.The usually described distal outer tube 89 winds the size after binding circle 92 Still less than the maximum outside diameter D for being equal to casing lip 60₄.Now in conjunction with Fig. 3 and Fig. 8, the distal end of the puncture outfit 5, the puncture needle 10 and 30 transition of described sleeve pipe component 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.Main includes transitional region not smooth at two, one is the ruler between the visual head 13 and casing lip 60 Very little mutation causes transition not smooth；The second is the transition of described air bag itself is not smooth, especially air bag Distal transition area It is not smooth caused by 83 wall thickness dimension unevenness and abnormity.One those skilled in the art is it is contemplated that by reducing the folder Angle A4 can reduce the mutation of the size between the visual head 13 and casing lip 60, however reduce the included angle A₄Simultaneously again really 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 size of the air bag body 81 and distal outer tube 89 axially is typically larger than and is equal to 20mm.Those skilled in the art be to be understood that due to patient abdomen space limit, described sleeve pipe component 30 or 50 it is remote End, which penetrates stomach wall and enters the length in abdominal cavity, is typically not greater than 20mmm, otherwise influences surgical procedure or causes puncture process favorite outer The risks such as internal organs are damaged, therefore L cannot be extended₄To reduce transition mutation.

Influence of the transition mutation for puncture force is quite big: the airbag casing pipe group for the 12mm specification that such as patent P692 is disclosed Part (without airbag fold) passes through tissue cut, and when the bar portion of no air bag passes through, resistance is substantially zeroed or very little, works as air bag When passing through notch, hump drag reaches 25 pounds；And after using airbag fold technology, hump drag drops to 13 pounds.This The structure size mutation that the random accumulation of air bag body that air bag is primarily due to when can reduce puncture through well-regulated folding generates, from And help largely to reduce penetration Resistance.Those skilled in the art is to be understood that the prominent of air bag body flexible Resistance difference dissident caused by becoming of different sizes is through very big, and rigidly mutation causes resistance to increase between the visual head 13 and casing lip 60 It will be apparent from greatly.The visual puncturing needle of 12mm specification is disclosed in American invention application US20070066988A1 penetrates patient's abdomen The puncture force (Direct perforantes method) of wall is about 15 pounds.The operating comfort of usually less than 15 pounds of puncture force is preferable, and is higher than 18 pounds usually will affect control of the operative doctor for puncture process.Obviously, if counting air bag in is mutated increased resistance, Yi Jike Resistance caused by depending on being mutated between first 13 and casing lip 60, the puncture outfit 7 can not be applied in Direct perforantes method substantially.

Fig. 9-10 depicts the sheath 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 includes to be clipped in Instrument seal 112 between upper warehouse 111 and upper cover body 113.Second seal assembly include be 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 At shell 103.The shell 103, instrument seal 112 and zero sealing, 122 composition include the sealing system of substantially aligned hole.Institute It states banding instrument when instrument seal 112 is inserted into external device in described sleeve pipe component 100 and forms sealing；Zero sealing 122 are generally not provided the sealing for insertion instrument, and are automatically closed when instrument is removed and form sealing.To save length, Warehouse 111 in omission, instrument seal 112, upper cover body 113, lower cover 121, zero sealing 122 structure and its be connected and fixed mode Details describe and statement, understand in combination with the associated description disclosed in aforementioned CN201610630336.5 Chinese invention application on 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 There are many implementations of envelope 122, such as the fFour piece type instrument seal component disclosed in U.S. patent Nos US8029475, example Fold-type instrument seal component as disclosed in US7789861, such as the instrument comprising woven cloth disclosed in US6482181 are close Sealing assembly, such as the fFour piece type zero that US5443452 is disclosed seal, 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 sealing, zero sealing, upper warehouse, upper cover body, lower cover etc..

With continued reference to Fig. 9-10, the lower warehouse 123 also includes lower case 124 and is attached thereto and extends to distal end 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.

1-13 referring now to figure 1, the hollow sleeve 210 include to have internal diameter D_iInner cylinder 211 and have outer diameter D_oIt is outer Cylinder 213 and therebetween with a thickness of T_a1Casing wall 212；The distal end of the hollow sleeve 210 also includes open casing lip 220, described sleeve pipe lip 220 includes the inclination cylinder 227 of opening lip 229 and transition lip 228 therebetween, the inner cylinder 211 Casing skew wall 226 is limited with inclination cylinder 227.Wall thickness of the described sleeve pipe skew wall 226 in opening 229 position of lip is T_b1, The wall thickness of 228 position of transition lip is T_b2.The wall thickness of described sleeve pipe skew wall 226 is by distally proximally gradually increasing, usual wall thickness Increased rate is smaller, so that the transition between puncture needle and sheath assembly is more smooth.In a kind of preferred design scheme, 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 when < 0.1mm_b1> 0.3mm When to will lead to more serious transition not smooth.Usual T_b2Then the intensity of hollow sleeve 210 is inadequate when < 0.8mm, and T_b2> The outer diameter of the hollow sleeve 210 is too big when 1.1mm, damage of the reduction of unfavorable subthreshold for patient.Another is excellent Included angle A in the design scheme of change, between the inclination cylinder 227 and the inner cylinder 211_lip, wherein 3 °≤A_lip≤15°。 The A_lip3 ° of < lead to the intensity of casing lip 220 not enough and are difficult to manufacture, and the A_lip15 ° of > lead to puncture needle and casing group Transition between part is not smooth.

1-13 is continued to refer to figure 1, the proximal location of the hollow sleeve 210 includes to install check valve assembly 140 Valve seat 126.The valve seat 126 includes the mounting hole 126a and sink hole 126b that cylindrical side wall limits.The hollow sleeve 210 It also include (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 formed side opening 126c and with the sink hole 126b connection；The runner 216 extends distally to institute The distal portions for stating hollow sleeve 210 close on described sleeve pipe lip 220.

4-16 referring now to figure 1, the air bag component 250 include outer tube 260 and air bag lip 280 and intervenient gas Utricule 270.The air bag body 270 includes the gas that balloon proximal transition region 272 and air bag Distal transition areas 276 and 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 to match with the shape and size of described sleeve pipe skew wall 226.Institute Air bag transition lip 287 is stated by distally proximally extending and being seamlessly connected simultaneously smooth transition with air bag Distal transition area 276.Institute Stating outer tube 260 includes distal outer tube 268 and proximal outer tube 264 and the outer tube wall 266 extended therebetween, the distal outer tube 268 with the balloon proximal transition region 272 seamless connection and smooth transition, the outer tube wall 266 limit and the outer cylinder The adaptable cylindrical hole 265 of 213 shape and size, the proximal outer tube 264 limit outer tube opening 262.A kind of preferred side In case, the gentle utricule 270 of the air bag lip 280 has substantially homogeneous wall thickness T_a3.In a kind of optional scheme, 0.05mm≤ T_a3≤ 0.1mm, air bag body is difficult to manufacture when the wall thickness of usual air bag body is less than 0.05mm and its intensity is not enough easy to appear rupture Failure, and when wall thickness of air bag body is greater than 0.1mm, largely increases after evacuating and mutually folds the material thickness of accumulation, compared with Big degree increases puncture force.

6-17 referring now to figure 1, the air bag component 250 are mounted 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 casing 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 welding or glue bond together and between the distal outer tube 268 and the runner 216 not be bonded (welding), shape At non-fully closed seam region 297.The outer tube wall 266 contacts with the outer cylinder 213 but is not fixed or uses 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 Closed proximal end seam region 295.The then check valve assembly 140, runner 216, outer cylinder 213, air bag component 250, proximal end Seam region 295 and taper seam region 299 form closed air bag cavity 290.

0, Figure 16, Figure 18 and 19 referring now to figure 1, the check valve assembly 140 include bonnet 141, one-way plug one 145, spring 146 and valve seat 126.The bonnet 141 includes the stomata 147 through it, forms the inner wall 144 and outer wall 143 of stomata 147. The inner wall 144 and outer wall 143 form annular groove, and the mounting hole 126a limited with valve seat 126 is matched, the mounting hole 126a With the side opening 126c connection.The outer wall 143 includes elastic arm 142, and 142 distal end of elastic arm is provided with limit hole 142a, size and position and the limited post 126d in 126 outside of valve seat match.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, and elastic arm 142 becomes Limited post 126d is entered in limit hole 142a after shape, and compressed spring 146.Since the reaction force of spring 146 is by one-way plug one 145 push out and withstand 140 inner wall 144 of bonnet, 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 is designed and sized to match with the shape and size of standard syringe point mouth.The gas The distal end in hole 147 includes conical bore 147b, and the one-way plug one 145 includes the matched cone 145b and Xiang Yuan of taper therewith Hold the planar wall 145a extended to form.The planar wall 145a include air channel 145c and the cone 145b include a word or Cross air channel 145d.Under natural conditions, 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 area is inserted into institute It states in the stomata 147 of check valve assembly 140, and inwardly opens one-way plug one 145, then carry out gas injection.Gas passes through unidirectional The air channel 145c and air channel 145d of plug 145, then entered in valve seat 126 via the gap of 140 inner wall 144 of bonnet, and pass through Sink hole 126b, side opening 126c, runner 216, which enters within air bag body 270, to be swollen.After taking out syringe SY, spring 146 Bounce pushes out one-way plug one 145, and the cone 145b and the conical bore 147b match to form sealing, avoids gas Leakage.

As depicted in figs. 20-23, sheath assembly 100 goes back the outer fixation kit 160 of occlusion body, and the external fixation kit 160 wraps Include fixed pad 150 and latch fitting 155.It includes but is not limited to rubber, sponge etc. that 150 materials of the fixed pad, which are flexible material,.It is described Fixed pad 150 includes the pad distal end 151 and pad proximal end 153 and the air ring slot 152 extended therebetween, the hole of its distal end 154 through fixed pad 150, and aperture is slightly smaller than the outer diameter of outer tube 260, the outside of outer tube 260 can be nested by swelling. Pad distal end 151 is tightly attached to around the notch of stomach wall, protects notch, and the air pressure in stomach wall is avoided to leak from incision site.The lock 155 material of part includes that there is the plastic material (such as polycarbonate) of favorable elasticity or metal material (such as SUS301) to be made. The latch fitting 155 includes latch fitting body 156 and handle 157 and position-limited edge 159 that 156 both ends of latch fitting body are extended.The latch fitting Body 156 curls into latch fitting hole 158 by prefabricated, and latch fitting 155 forms the coupling mechanism force of inward curl.Latch fitting body 156 it is inside Crimp force staggeredly limits the handle 157 at 156 both ends of latch fitting body and position-limited edge 159, 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 slot 152 of fixed pad 150, since latch fitting 155 forms the coupling mechanism force of inward curl, so under 155 release conditions of latch fitting, lock Part 155 is by the fixed locking of pad 150 and device to hole 154 generates internal enclasping force.

Referring now to Figure 23-24, sheath assembly 30 penetrates patient's stomach wall and is inserted into the channel after body cavity as instrument disengaging body cavity, It may be needed in surgical procedure while using one or more sheath assemblies.When surgeon operates various instruments, such as nipper, Scissors, contact generates frictional force between the surgical instruments such as stapler and sheath assembly 30, these frictional force may result in casing Component 30, in vivo or to extracorporeal movement, if sheath assembly 30 is not fixed, may result in along stomach wall and skid off stomach wall Or be further inserted into chamber, therefore sheath assembly be firmly fixed on stomach wall just it is of crucial importance.Described sleeve pipe component 100 Air bag body 270 be in inside patient's body lumen and swollen, along the axially adjustable external fixation kit of sheath assembly 100 160 position steps up the stomach wall between the air bag body 270 and external fixation kit 160, thus 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 the 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 to be contemplated that.

Described sleeve pipe component 100 is packed into before final sterilization packaging after completing assembling, the air bag body 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 air bag body 270.When described After 100 complete penetration patient's body wall of sheath assembly, the position of described sleeve pipe component 100 is adjusted, method as previously described uses Syringe SY swells the air bag body 270.Then the outer fixation kit 160 of adjusting body distinguishes air bag body 270 and fixed pad 150 Patient's body wall is clamped in the inner side and outer side of stomach wall, realizes the fixation of sheath assembly 100.When operation completion, need to take out set When tube assembly 100, the gas nozzle that syringe SY can be used pushes the one-way plug one 145 open and evacuates the gas in the air bag body 270 So that the diminution of air bag body 270 is reset to original state.

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

And the sheath assembly 100 of present disclosure has and is used for Direct perforantes without air bag with what the prior art disclosed The substantially equivalent casing lip 220 of sheath assembly；The air bag component 250 is inclined comprising matching with described sleeve pipe lip 220 Air bag lip 280；And the air bag lip 280 matches coincidence using welding (or Nian Jie) is fixed with described sleeve pipe lip 220 to reduce The size mutation set.In addition, the wall thickness Ta3 of the gentle utricule 250 of air bag lip 280 of air bag component 250 of the present invention is substantially equal Even and 0.05mm≤T_a3≤ 0.1mm strengthens the intensity of air bag and reduces wall thickness control difficulty, while reducing material thickness The deformation force of transitional region caused by degree is uneven, so that sheath assembly of the present invention 100 can be used for Direct perforantes Method.Certainly, sheath assembly 100 of the present invention can be used in Hasson method.

When using the fixed air bag lip 280 of glue bonding way and casing lip 220, 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 can reach ideal Fixing intensity, thus reduce bonding location size mutation.However it can also be selected according to the material difference of the gentle utricule of casing Other glue adaptable and that meet bio-compatibility requirement therewith, such as epoxy resin, polyester glue etc..Using welding side When the fixed air bag lip 280 of formula and casing lip 220, there are many kinds of specific welding methods class, 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 It is smooth (after trimming to the residual side of welding very that mode makes the air bag lip 280 and casing lip 220 connect reliable and transition To seamless smoothly transit can be achieved), and the wall thickness of new casing lip that welding manner is formed is less than the air bag lip 280 and set The sum of the wall thickness 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 improve packaging efficiency when air bag lip 280 and casing lip 220 are fixed to each other and fixation Fastness.It, can be along the axial folding soldering tip of sheath assembly when the taper fit 230 ensures to weld especially for being welded and fixed And support fixture, therefore can disposably weld and to form the taper seam region 299.Rather than it to be welded in the case where taper fit It connects and to form the closure seam of annular and usually require multiple welding, and multiple welding be easy to cause the unexpected thinning generation in air bag body part Root cuts failure.

Figure 25-26 depicts the air bag component 350 of another embodiment.The air bag component 350 includes 301 He of axis Along axis, outer tube 260 and air bag lip 280 and intervenient air bag body 370 are set.The i.e. described air bag component 350 with it is described Air bag component 250 is compared, and except degasification utricule is different, other structures are substantially equivalent.Finer, the air bag body 370 includes 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 wraps 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 extends and with 376 seamless link of air bag Distal transition area and smooth transition.The outer tube 260 includes 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 Cross the seamless connection of area 372 and smooth transition.In a kind of optional scheme, the gentle utricule 370 of the air bag lip 280 has substantially Even wall thickness T_a4, and 0.05mm≤T_a4≤0.1mm。

Figure 26 depicts the projection view that 350 Formation cross-section of air bag component is cut by the arbitrary section of axis 301. In a kind of preferred scheme, in the section shown in Figure 26, 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, for another kind optionally in implementation, air bag Distal transition area 376 has the approximate round of continuous lateral gradually indent Arc shape, air bag transition angle A_dWith unlimited air bag transition angle A_dx.In a kind of finer design scheme, the transition Angle A_dxBy being distally proximally gradually increased, and closer to the transition angle A of air bag main body 374_dxIncreased rate is bigger. Those skilled in the art is to be understood that this by distally proximally the smooth Transition Design being gradually increased reduces shape The mutation of shape and size is conducive to the gentle utricule of air bag lip for forming whole uniform wall thickness when blow molding manufacture, is conducive to more into one The reduction puncture force of step.

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

In another aspect of the invention, a kind of sheath assembly 300 containing air bag for being exclusively used in Direct perforantes method is proposed.Institute The structure and composition for stating sheath assembly 300 and described sleeve pipe component 100 is substantially equivalent, more precisely, with the air bag component The 350 substitution air bag components 250 constitute sheath 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 air bag body 370 swell after have maximum outside diameter D_b, wherein 1.5D_t≤D_b≤1.7D_t.Such as The outer diameter of a kind of sheath assembly 300 of 12mm specification, outer tube is 15.0mm, and the outer diameter after air bag cubical expansion is big is set as 22.5mm≤D_b≤25.5mm.Usual Db < 22.5mm is easy to cause fixed force inadequate, and D_b> 25.5mm is easy to cause air bag to take out The material being stacked with after sky is excessive and increases penetration Resistance.And be used for the 12mm specification of Hasson method airbag casing pipe component its Maximum outside diameter after air bag swells is usually 30mm~34mm.Maximum outside diameter D after air bag body 370 swells_b, 1.5D_t≤D_b≤ 1.7D_tWhen, it is usually not used in Hasson method, because lesser 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 and casing lip of the present invention, gas Taper fit between capsule lip and casing lip, the gentle utricule of air bag lip of uniform thickness, by the air bag being distally proximally gradually increased Body, and reasonable air bag body size setting etc., can get relatively small puncture force, so that tube assembly containing Air sac cover can be used for In Direct perforantes method, it is fixed on body wall so that described sleeve pipe component is stronger.

Those skilled in the art is to be understood that the stretch-blow method disclosed in patent P692 typically results in air bag body It is even with the wall unevenness for the tube body being attached thereto, it cannot or be difficult to produce the substantially homogeneous air bag of wall thickness of the present invention The gentle utricule of lip.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 method of blowing generallys use the continuous note of automation and blows, i.e. first injection molding and pre- inflation parison, then rapidly from 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 is blown using discontinuous note Mode manufactures the air bag component 250 (350), and key step is as follows:

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 ASTMD2240-97 relevant regulations.Current disclosed document With the airbag casing pipe component having been commercialized, air bag usually by hard plastic material (such asPolyester,Poly- second Alkene) it is blow molded.Semi-rigid or soft thermoplastic elastomer (TPE) (abbreviation TPE), typical material include 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) is conducive to further reduce puncturing because TPE material has enough intensity and good flexibility Resistance.However since the mobility of TPE material is relatively low and more difficult blow molding.Especially for air bag component 250 of the present invention (350) since comprising the extended air bag body 270 outer tube 260 and swollen, draw ratio is typically larger than 10/1, current research Show or extremely difficult wall thickness of the present invention basic impartial air bag body and air bag to be made using when TPE material blow molding Lip.Even if being blow molded such as described this kind of draw ratio of air bag component 250 (350) using duroplasts is greater than 10/1, and wall thickness is less than etc. It is also highly difficult in the part of 0.1mm.

In an additional aspect of the present invention, a kind of air bag component 450 convenient for 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, the air bag component 350 is remote from its outer tube Cutting is held at 268 to be divided into first part 350a and second part 350b, then by the first part 350a and second part 350b Welding or bonding are linked to be whole air bag component 450.Finer with reference to Figure 27-29, the first part 350a includes air bag Lip 280 and the air bag body 370 being attached thereto.The air bag body 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 proximally extend to form balloon proximal and open 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 distally proximally extend and with the gas The seamless connection of capsule Distal transition area 376 and smooth transition.The second part 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 limit cylindrical hole 465, the proximal outer tube 464 limits 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 to be formed seam region 491, so that the first part 350a and second part 350b are linked to be entirety Air bag component 450.

In an additional aspect of the present invention, a kind of manufacturing method of the air bag component 450 is proposed, it is main comprising being blow molded and repairing Cut process, extrusion molding and trimming process, welding sequence or bonding process.

Blow molding and trimming process: it method blow molding is blown using previously described improved two step note manufactures and trims and obtain described the A part of 350a.

Extrusion molding and cutting process: the second part 350b is manufactured using extrusion process and is 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 overlap 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 increases relative to the air bag component 350 Form the welding sequence or bonding process of seam region 491, however the air bag component 450 split into first part 350a and After second part 350b, help to improve production efficiency on the basis of optimizing product function and guaranteeing product quality.This reality Since the first part 350a does not include extended outer tube in example, draw ratio is decreased to less than being equal to 3/1, thus larger The difficulty for reducing blow molding of degree.And the second part 350b is produced using extrusion process, production equipment is simple, production Efficiency is very high, therefore the production cost of the second part 350b is very low.Comprehensive consideration, although increasing to form the seam 491 welding sequence or bonding process, but whole production cost does not obviously increase, while ensuring that TPE material can be used Material produces the soft gentle utricule of air bag lip with generally uniform wall thickness.

Figure 30-32 depicts the lower warehouse 123a of another embodiment of the invention, the lower warehouse 123a and it is described under The structure and composition of warehouse 123 is substantially equivalent, and the main distinction of the lower warehouse 123a and the lower warehouse 123 is air bag group Part is different with runner generation type.Finer with reference to Figure 30, the lower warehouse 123 includes 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 includes to have The inner cylinder 211 of internal diameter Di and outer cylinder 213 with outer diameter D o and therebetween with a thickness of Ta1 casing wall 212；It is described hollow The distal end of casing 210 also includes open casing 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 casing skew wall 226.The hollow sleeve 210 Proximal location include to the valve seat 126 of installing check valve assembly 140, the valve seat 126 includes to extend transversely through valve seat wall portion The side opening 126c divided.Compared with the lower warehouse 123, there is no the runner of recess on the outer cylinder 213 of the lower warehouse 123a 216, so as to guarantee hollow sleeve 210 intensity it is enough under the premise of, using relatively thinner casing wall 212, thus more into The reduction outer diameter D o of one step.

Now with continued reference to Figure 31-32, the air bag component 450 is mounted on the hollow sleeve 210 of the lower warehouse 123a Outside, wherein air bag lip 280 is 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 casing skew wall 226, thus 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 proximal end seam region 495.The proximal openings 371 are welded with the outer cylinder 213 or glue is bonded in It is formed together non-fully closed seam region 497.Not be bonded or shape between the outer tube wall 466 and the outer cylinder 213 At non-fully closed bonding, the runner 216a (not shown) of connection air bag body 370 is reserved, i.e., with outer tube wall 466 and column jacket Gap between face 213 substitutes aforementioned runner 216.To sum up, the check valve assembly 140, runner 216a, outer cylinder 213, air bag Component 450, proximal end seam region 495 and taper seam region 499 form closed air bag cavity 490.This field one is common Technical staff be readily apparent that, when the sheath assembly containing air bag penetrates patient's stomach wall, when being packed tightly by patient muscle, muscle gives institute The package power for stating outer tube wall 466 may cause outer tube wall 466 and the gap of the outer cylinder 213 reduces or even blocks, to hinder Break the runner 216a.It is potentially based on the considerations of preventing runner from blocking, its casing wall of the sheath assembly of patent P692 disclosure is gone back There is the runner of recess.However under normal conditions, blocking the situation of the runner 216a will not occur.Up to the present, it usually adopts 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.

Many different embodiments and example of the invention are had shown and described.One ordinary skill of this field Personnel can make adaptive improvement to the method and instrument by suitably modified without departing from the scope of the invention. Such as the situation that Figure 31-32 depicts air bag lip opening lip 289 and the lip 229 that is open is misaligned in axis direction.Such as it is described First part 350a and second part 350b is assembled into the hollow sleeve after need not being bonded or welded into an entirety in advance again 280 outside, as long as balloon proximal opening 371, distal outer tube 468 and the outer cylinder 213 form runner and remove runner Except other regions it is completely enclosed, and kinds of processes can be realized.Several kinds of amendment schemes are referred, for For those skilled in the art, other amendment schemes are also to be contemplated that.Therefore the scope of the present invention should be according to additional Claim, while it being understood not to the structure for being shown and being recorded by specification and attached drawing, the particular content of material or behavior It is limited.

Claims

1. a kind of improved sheath assembly containing air bag includes the first seal assembly and the second seal assembly, second sealing Component includes lower case and hollow sleeve coupled and to distal end extension, and first seal assembly, second is close Sealing assembly and hollow sleeve include connection 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 also includes Open casing lip, described sleeve pipe lip include the inclination cylinder of opening lip and transition lip therebetween, the inner cylinder and inclination Cylinder limits casing skew wall；

2) described sleeve pipe component also includes the inflatable air bag component to swell, to inflation/deflation check valve assembly and will be described The airflow channel of air bag component and check valve assembly connection；

3) air bag component includes air bag lip and the air bag body that is attached thereto, the air bag lip to distally extend to form with it is described The air bag skew wall that the shape and size of casing skew wall match；The air bag lip proximally extends to be connect and suitable with the air bag body It slips over and crosses；The air bag body includes balloon proximal transition region, air bag Distal transition area and the air bag main body extended between the two, Air bag Distal transition area has continuous lateral gradually interior concave circular arc shape；

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

2. sheath assembly as described in claim 1, it is characterised in that: air bag transition angle Ad has multiple air bag transition angle Adx, the transition angle Adx are by being distally proximally gradually increased, and the transition angle Adx of closer air bag main body is increased Rate is bigger, and the gentle utricule of air bag lip has uniform wall thickness T_a3, and 0.05mm≤T_a3≤0.1mm。

3. sheath assembly as described in claim 1, it is characterised in that: the air bag lip and air bag Distal transition area are seamless Connect and smooth transition, the air bag component also includes outer tube, the outer tube include distal outer tube and proximal outer tube and The outer tube wall extended therebetween, the distal outer tube are seamlessly connected to form entirety or described with the balloon proximal transition region Distal outer tube and the balloon proximal transition region constitute connection seam to form an entirety.

4. sheath assembly as described in claim 1, it is characterised in that: the outer tube has outer diameter D_t, the air bag cubical expansion is big There is maximum outside diameter D afterwards_b, wherein 1.5D_t≤D_b≤1.7D_t。

5. sheath assembly as claimed in claim 3, it is characterised in that: 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. sheath 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 fixation of the outer surface of the valve seat of the proximal outer tube and the outer cylinder and check valve assembly forms complete envelope The proximal end seam region closed forms the air-flow of air bag component and check valve assembly described in connection between the outer tube and outer cylinder Channel.

7. sheath assembly as described in claim 1, it is characterised in that: fixed form between the air bag skew wall and casing skew wall Include welding manner or glue bonding way.

8. sheath assembly as described in claim 1, it is characterised in that: the angle between the inclination cylinder and the inner cylinder A_lip, wherein 3 °≤A_lip≤15°。

9. the manufacturing method for the air bag component that sheath assembly as described in claim 1 includes, it is characterised in that: the air bag group Part includes that the first part that cutting is divided into from its distal outer tube and second part, the balloon proximal transition region proximally extend Balloon proximal opening is formed, key step is as follows:

10. the manufacturing method of air bag component as claimed in claim 9, it is characterised in that:

The improved two steps note blows method and manufactures the air bag component using the discontinuous note mode of blowing, and key step is as follows:

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