CN106963516A - Device for intracavity in-situ fenestration and puncture - Google Patents

Device for intracavity in-situ fenestration and puncture Download PDF

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Publication number
CN106963516A
CN106963516A CN201710179335.8A CN201710179335A CN106963516A CN 106963516 A CN106963516 A CN 106963516A CN 201710179335 A CN201710179335 A CN 201710179335A CN 106963516 A CN106963516 A CN 106963516A
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China
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puncture
balloon
handle
push rod
distal end
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CN201710179335.8A
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Chinese (zh)
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李阳
张庭超
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杭州唯强医疗科技有限公司
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Priority to CN201710179335.8A priority Critical patent/CN106963516A/en
Publication of CN106963516A publication Critical patent/CN106963516A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts

Abstract

The invention discloses a device for intracavity in-situ fenestration and puncture. The device comprises a balloon catheter and a puncture needle assembly, wherein the balloon catheter is internally and coaxially sleeved with the puncture needle assembly. The balloon catheter comprises a balloon push rod with at least two cavities, a balloon body and a balloon catheter base, wherein the balloon body is mounted at the distal end of the balloon push rod, and the balloon catheter base is mounted at the proximal end of the balloon push rod. The puncture needle assembly comprises a puncture push rod, a puncture needle and a puncture handle, wherein the puncture needle is mounted at the distal end of the puncture push rod. The puncture handle comprises a proximal handle and a distal handle, wherein the distal handle is fixedly or removably fixedly connected to the balloon catheter base; the proximal handle is connected to the puncture push rod and disposed in the direction of the distal handle. A puncture control structure is disposed between the distal and proximal handles, and used for controlling puncture depth of the puncture needle and locking the puncture needle. The device for intracavity in-situ fenestration and puncture is capable of precisely controlling the puncture depth, adjusting the puncture depth, locking the puncture needle, and precisely puncturing and maintaining puncture sites at the center of branch blood vessels.

Description

腔内原位开窗穿刺装置 Windowing means puncturing the cavity situ

技术领域 FIELD

[0001]本发明属于医疗器械技术领域,涉及一种腔内介入器械,尤其涉及一种腔内原位开窗穿刺装置。 [0001] The present invention belongs to the technical field of medical equipment, relates to an endovascular device, particularly to a piercing device cavity situ fenestration.

背景技术 Background technique

[0002]随着腔内血管重建手术中不断开展,覆膜支架的应用也越来越多,但是有些特殊部位使用覆膜支架会影响动脉分支血管的血液供应,如主动脉弓、腹腔动脉干、双侧肾动脉和肠系膜上动脉等部位,使得在这些部位采用覆膜支架受到极大限制。 [0002] As Endovascular ongoing reconstruction surgery, stent graft applications more and more, but some special parts using stent-grafts will affect the blood supply artery branch vessels such as the aortic arch, celiac artery, double side of the renal artery and mesenteric artery and other parts, so that the stent-graft use is extremely limited at these sites. 目前只能通过术式的改进,如采用杂交手术,或者通过器械的改进,如模块化支架、预开窗支架、分支支架、多层裸支架等等新型器械技术进行上述部位的支架手术,但是对于绝大多数病例,主动脉弓部病变位置解剖结构极为复杂,同时个体的差异明显,上述技术方案都强烈依赖于人体分支血管的解剖结构,对于其产品标准化和商业化带来了巨大的挑战。 Currently only through surgical improvements, such as using hybridization procedures, or by improving the device, modular stents, stent pre-windowing, branch stent, like bare stent novel multilayer devices above technique stenting site, but for the vast majority of cases, aortic arch anatomy of lesion location is extremely complex, and individual differences obviously, the above-mentioned technical solutions are strongly dependent on the anatomy of the human branch vessels, for its product standardization and commercialization of tremendous challenges.

[0003]覆膜支架原位开窗是一种更为先进的技术,包括能量开窗和机械开窗两大类,能量开窗是采用如激光、射频和热电偶等能量进行开窗操作,即通过能量对覆膜支架的烧蚀以产生预期的孔洞。 [0003] The stent-graft fenestration in-situ is a more advanced technology, including mechanical energy windowing and windowing two categories, is the use of energy windowing windowing operations such as laser, radiofrequency energy, and thermocouple, i.e., ablation of the stent-graft through the holes to produce the desired energy. 但这种方式对设备的要求高,如果能量太高,支架覆膜碳化,其分解物可能引发血栓形成,能量不足,又达不到预期的开窗效果。 However, high equipment requirements in this way, if the energy is too high, the film holder carbonization, which may lead to decomposition thrombosis, lack of energy, and achieving the desired results window. 同时能量不仅可以烧蚀支架覆膜,还有可能造成周围组织损伤,因此,机械开窗成为一种相对保守的,但较为安全的开窗方式。 While the energy not only ablative coating stents, may also cause damage to surrounding tissue, and therefore, the mechanical window into a relatively conservative, but more secure by windows.

[0004] —种机械支架原位开窗技术,是通过一个带导丝中空的针刺破支架覆膜,随后撤出穿刺针,使用切割球囊沿着导丝进入覆膜支架进行扩张。 [0004] - species in situ windowing mechanical support, by coating the stent with a broken needle hollow guidewire, followed by withdrawal of the needle, the use of cutting into the balloon to expand the stent-graft over the guidewire. 这种方式的问题在于针无法准确的找到分支血管开口的中央位置,在处于动态的血管内,容易穿偏或者损伤周围血管。 The problem with this approach is that the needle can not be accurately find the center of the opening of the branch vessel, the vessel is in a dynamic, easy to wear or partial peripheral vascular injury. 采用的针头和针管为一体式的结构,柔顺性不佳,刚性的针管不适合弯曲血管的部位;穿刺驱动不方便,以致穿刺力不足。 Used needles and syringes is a one-piece structure, poor flexibility, a rigid curved needle unsuitable for vascular site; puncturing driving is inconvenient, resulting in insufficient puncture force.

[0005]另一种机械支架原位开窗技术,是通过一个超硬导丝的末端支架覆膜,随后分别用1mm,3mm,8mm扩张球囊,逐步扩大开口位置。 [0005] Another windowing mechanical support in situ, the stent is coated cemented by a guidewire end, respectively and then 1mm, 3mm, 8mm balloon expansion, gradually expand the open position. 该方式的问题在于导丝穿刺仅适用于涤纶材质的覆膜支架,不适用于e-PTFE膜材质的覆膜支架。 The problem here is that the guidewire is only applicable to the piercing stent-graft polyester material, does not apply to e-PTFE membrane materials of the stent graft. 导丝无法准确的找到分支血管开口的中央位置,在处于动态的血管内,容易穿偏或者损伤周围血管。 The guide wire can not be accurately find the center of the opening of the branch vessel, in the vessel in a dynamic, easy to wear or partial damage to the surrounding blood vessels. 导丝尾部硬端穿刺后,在交换导丝的过程中,难以再次找到穿刺点。 After wire tail end hard puncture, during the exchange of the guidewire, the puncture site is difficult to find again. 导丝穿刺后,其孔径较小,不能使用大球囊一次扩张,必须借助于小球囊逐步扩张,增加的手术的时间和器械的成本。 After the guide wire puncturing, the pore size is small, can not use a large balloon dilation, a small balloon by means of gradual expansion must increase the time and cost of operation of the instrument.

[0006] 还有一种机械支架原位开窗方式为,采用锚定球囊固定于分支血管位置,穿刺针头在穿刺针杆推送下,刺破覆膜支架,然后使用扩张器穿刺点进行扩张,然后送入导丝,从而实现原位开窗。 [0006] There is also a mechanical support for the windows in situ, using an anchoring balloon is fixed to the branch vessel position, the needle puncture needle bar at a push, piercing stent-graft, the stent is then used to expand the puncture point, and then into the guide wire in order to achieve in-situ fenestration. 该技术方案中通过锚定球囊辅助定位在一定程度上改善了穿刺针的定位,但是锚定球囊较软,在复杂扭曲的血管内,球囊容易变形,难以保证穿刺点处于分支血管中央,存在刺偏的风险。 This aspect anchoring balloon assisted by the positioning of the puncture needle positioning improved to some extent, but the anchoring balloon is soft, twisted in the complex vessel, the balloon is easily deformed, it is difficult to ensure that the puncture site in the central branch vessel There is a risk thorn biased. 该技术采用同轴结构,内管和外管容易发生相对位移,在推送的过程中,球囊容易变形,若挤压到一起,增大推送阻力,若拉伸量过大,存在破裂的风险。 The technology uses a coaxial structure, the inner and outer tubes relative displacement easily occurs, in the process of pushing the balloon is easily deformed when pressed together to increase the resistance to push, if the stretch is too large, there is a risk of rupture . 穿刺针管体没有密封,穿刺成功后,不能通过穿刺针打造影液确认是否穿刺成功,同时穿刺证推送杆谷易打折,易误穿其他器械或者周围组织。 The puncture needle tube is not sealed, after successful puncture, the puncture can not confirm whether the stylus successful puncture contrast medium, while the valley easily puncture discount certificate pushers, wear easily mistaken for other instruments or surrounding tissue. 而且穿刺深度不能根据需要精密调节,容易造成穿刺深度过长而误伤对侧组织,或者穿刺深度不够造成穿刺不成功。 And piercing depth can not adjust as necessary precision, likely to cause accidental injury puncture depth is too long and contralateral tissue, causing puncture or piercing deep enough unsuccessful.

发明内容 SUMMARY

[0007] 本发明要解决的技术问题在于,针对穿刺深度不能进行精密调节,容易造成穿刺深度过长而误伤对侧组织,穿刺深度不够造成穿刺不成功的问题,提供一种能精确控制穿刺深度、穿刺深度可调、能锁定穿刺深度,并且准确穿刺保持穿刺点位于分支血管中央的腔内原位开窗穿刺装置。 [0007] The present invention is to solve the technical problems that can not be adjusted for precise penetration depth, penetration depth is likely to cause accidental injury contralateral tissue too long, resulting in insufficient penetration depth unsuccessful puncture problems, to provide a precise control of penetration depth , adjustable penetration depth, penetration depth can be locked, and accurately held puncture a blood vessel puncture site is located centrally in situ fenestration branch lumen piercing means.

[0008] 本发明进一步要解决的技术问题在于,提供一种穿刺针推送杆不容易打折、穿刺更加集中和有效的腔内原位开窗穿刺装置。 [0008] The present invention further technical problem to be solved is to provide a needle bar is not easy to push discount, more focused and effective puncture situ fenestration piercing device cavity.

[0009] 本发明解决其技术问题所采用的技术方案: [0009] The technical solutions of the present invention to solve the technical problem of:

[0010]腔内原位开窗穿刺装置的第一种技术方案是,包括球囊导管和同轴套装在球囊导管内的穿刺针组件; The first aspect [0010] In situ fenestration cavity lancing device that includes a balloon catheter and a coaxial needle assembly package in the balloon catheter;

[0011] 所述球囊导管包括带有至少两个腔体的球囊推送杆、设置在球囊推送杆远端的球囊囊体、设置在球囊推送杆近端的球囊导管座; [0011] The balloon catheter comprises a balloon having at least two cavities push rod, the push rod disposed at the distal end of the balloon of the balloon of the balloon, the balloon catheter hub of the balloon disposed at the proximal end of the push rod;

[0012]所述穿刺针组件包括穿刺推送杆、设置在穿刺推送杆远端的穿刺针头、穿刺手柄; [0013]所述穿刺手柄包括近端手柄和远端手柄,所述远端手柄与球囊导管座固定连接或可拆卸固定连接,所述近端手柄与穿刺推送杆连接,所述近端手柄顺远端手柄设置,所述远端手柄与近端手柄之间设有用于控制穿刺针头穿刺深度以及锁定穿刺针的穿刺控制机构。 [0012] The assembly includes a lancet puncturing the push rod, the push rod disposed at the distal end of the puncture needle puncture, the puncture handle; [0013] The puncture handle comprises a proximal handle and a distal end of the handle, the handle and the distal end of the ball balloon catheter hub fixedly attached or removably fixedly connected to the proximal end of the push rod is connected to the puncture handle, the handle proximal handle disposed along a distal end, the distal end of the puncture needle is provided for controlling the proximal end of the handle between the handle lancing penetration depth and a lock control mechanism puncture needle. [0014] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述近端手柄所述远端手柄顺远端手柄轴向移动,所述穿刺控制机构包括设置在近端手柄与远端手柄之间的最大行程控制组件和穿刺锁定组件。 The first aspect of the cavity in situ [0014] windowing lancing device, preferably, the distal end of the proximal handle of the handle to move axially along the distal end of the handle, the control mechanism comprises a lancing disposed near the maximum stroke between the control assembly and the piercing end of the handle and the distal end of the handle lock assembly.

[0015] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述最大行程控制组件包括设置在近端手柄上或远端手柄上的行程槽,对应的远端手柄或近端手柄上设有限位块;所述行程槽顺穿刺推送杆轴向设置,所述限位块配合在行程槽中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度。 The first aspect of the cavity in situ [0015] windowing lancing device, preferably the maximum stroke travel control assembly includes a handle or grooves in the proximal end of the distal end of the handle, the distal end of the handle corresponding to or a handle is provided on the proximal end stopper; cis puncture the stroke groove disposed axially pushers, the stop block and slidably fitted in the sliding groove travel a maximum distance allowed for the maximum depth of the puncture needle.

[0016] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺锁定组件为近端手柄控制部上设置多个定位锁定槽,对应的远端手柄上设有弹性锁定件,所述弹性锁定件弹性顶压在定位锁定槽中将穿刺针位置锁定,在外力驱动近端手柄,使得弹性锁定件在不同的定位锁定槽之间滑动。 The first aspect of the cavity in situ [0016] windowing lancing device, preferably a plurality of said piercing locking assembly is positioned on the lock groove portion is a proximal control handle, the handle is provided on the distal end of the corresponding the resilient locking member, said resilient locking member positioned elastically pressed against the lock groove to lock the position of the puncture needle, the driving force in the proximal end of the handle, the locking member such that sliding between the resilient locking groove different positioning.

[0017] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺锁定组件包括限位在远端手柄上的驱动套,对应驱动套的近端手柄上设有滑动块,所述滑动块与驱动套通过螺纹啮合,旋转驱动套驱动滑动块沿穿刺推送杆轴向滑动。 The first aspect of the cavity in situ [0017] windowing lancing device, preferably, the locking assembly includes a stopper piercing distal end of the handle on the drive sleeve, the drive sleeve corresponding to the proximal end of the handle is provided with slider, the sliding sleeve by means of threaded engagement with the drive block, the rotary drive sleeve driving the sliding blocks to slide axially along the puncture pushers.

[0018] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述最大行程控制组件包括所述远端手柄上设有的行程槽,所述行程槽沿穿刺推送杆轴向设置,且所述滑动块穿过行程槽与驱动套螺纹啮合,所述滑动块配合在行程槽中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度。 Cavity in situ [0018] according to a first aspect of windowing lancing device, preferably the maximum travel stroke of the control assembly comprises a groove provided on the distal end of said handle, said groove along the puncture stroke pushers axially disposed, and the stroke of the slide block through the sleeve threaded engagement with the drive slot, the slider fitted in the sliding groove and the sliding stroke of the maximum distance allowed maximum depth of the puncture needle.

[0019] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺针头和穿刺推送杆都设有中空封闭腔体,二者的中空封闭腔体联通。 The first aspect of the cavity in situ [0019] windowing puncture device, the puncture needle is preferable that the push rod piercing has a hollow closed chamber, a hollow closed chamber both China Unicom.

[0020]所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺推送杆为可号曲并具有支撑力的管体。 The first aspect of the cavity in situ [0020] windowing lancing device, preferably push the piercing tube to be bent and having a number of rod supporting force.

[0021] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺推送杆为覆膜的弹簧管。 The first aspect of the cavity in situ [0021] windowing lancing device, preferably for the coating of the piercing tube spring pushers.

[0022] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述穿刺推送杆的中空封闭腔体中穿装有用于加强穿刺推送杆支撑力的衬丝。 The first aspect of the cavity in situ [0022] windowing puncture device, the hollow puncturing the closed chamber preferably through the push rod fitted with the pushers for puncturing strengthen the supporting force of the lining wire.

[0023] 所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述球囊推送杆至少包括一个导丝腔和一个充盈腔,所述穿刺针头和穿刺推送杆穿装在所述导丝腔中,所述充盈腔远端与球囊囊体联通、近端连接有用于对球囊囊体充盈的充盈头。 The first aspect of the cavity in situ [0023] The windowing lancing device, the balloon preferably comprises at least one push rod guide wire lumen and a filling chamber, and the piercing needle piercing pushers reeved the guidewire lumen, the distal end of the balloon cavity filling balloon Unicom, a proximal end connected to the balloon for filling the balloon filling head.

[0024] 充盈所述的腔内原位开窗穿刺装置的第一种技术方案中,优选所述球囊囊体为非顺应性或半顺应性球囊囊体。 [0024] The first aspect of the cavity filling situ fenestration lancing device, the balloon is preferably a non-compliant balloon or balloon semi-compliant balloon.

[0025] 腔内原位开窗穿刺装置的第二种技术方案是:一种腔内原位开窗穿刺装置,包括球囊导管和同轴套装在球囊导管内的穿刺针组件; A second aspect [0025] In situ fenestration cavity lancing device is: An endoluminal situ fenestration lancing apparatus comprising a balloon catheter and a coaxial needle assembly package in the balloon catheter;

[0026] 所述球囊导管包括带有至少两个腔体的球囊推送杆、设置在球囊推送杆远端的球囊囊体、设置在球囊推送杆近端的球囊导管座; [0026] The balloon catheter comprises a balloon having at least two cavities push rod, the push rod disposed at the distal end of the balloon of the balloon of the balloon, the balloon catheter hub of the balloon disposed at the proximal end of the push rod;

[0027] 所述球囊推送杆的头端在球囊囊体充盈后位于血管中心位置; [0027] The head end of the balloon after the balloon pushers capsule filling position is located in the center of the blood vessel;

[0028] 所述穿刺针组件包括穿刺推送杆、设置在穿刺推送杆远端的穿刺针头、穿刺手柄; [0029]所述穿刺推送杆为可弯曲并具有支撑力的管体,所述穿刺推送杆中穿装有用于加强穿刺推送杆支撑力的衬丝。 [0028] The assembly includes a lancet puncturing the push rod, the push rod disposed at the distal end of the puncture needle puncture, the puncture handle; [0029] Push rod to puncture the flexible tubular body and having a supporting force, push the piercing with a reinforcing rod through pushers piercing wire supporting force of the lining.

[0030] 本发明第一种技术方案中,在穿刺手柄上设有穿刺控制机构,用于精确控制穿刺针穿刺深度以及锁定穿刺针,实现了穿刺深度可调,避免造成穿刺深度过长而误伤对侧组织,或者穿刺深度不够造成穿刺不成功。 [0030] The first aspect of the present invention, is provided in the puncture handle penetration control means for accurate control of the depth of the puncture needle and locking the needle to achieve a penetration depth adjustable, to avoid accidental injury is too long penetration depth contralateral tissue, causing puncture or piercing deep enough unsuccessful. 并且穿刺控制机构可以使得穿刺针头稳定在穿刺位置,防止穿刺成功后的回撤,在穿刺成功后,导丝沿着穿刺针内腔进入主体血管内,准确地找到分支血管开口的中央位置,使得在处于动态的血管内,导丝不容易穿偏或者损伤周围血管。 And the control means may cause the piercing needle piercing the piercing stable position, preventing retracement after successful puncture, after a successful puncture, the puncture needle along the guide wire into the lumen of a blood vessel within the body, and accurately find the center position of the branch vessel opening, such that in a blood vessel in a dynamic, the guidewire is not easy to wear or partial damage to the surrounding blood vessels. 另外,球囊推送杆的头端在球囊囊体充盈后位于血管中心位置,即采用球囊导管为自中心结构,球囊推送杆头端在球囊囊体充盈后就可以位于血管中心位置,提高穿刺的有效性。 Further, the push rod head end of the balloon of the balloon capsule filling position is located in the center of the blood vessel, i.e. from the use of a balloon catheter is the central structure, push the head end of the balloon after the balloon capsule filling may be located at the center position of the blood vessel to improve the effectiveness of the puncture. 选用球囊囊体为非顺应性或半顺应性球囊囊体,在复杂扭曲的血管内,相比顺应性球囊更容易使球囊指向分支血管开口的位置。 Selection of the balloon or balloon is non-compliant balloon is semi-compliant balloon, in the vascular complex twisted, is easier as compared to the balloon is a compliant balloon points to the location of the branch vessel opening.

[0031] 现有技术上中穿刺针管体没有密封,穿刺成功后,不能进行造影确认是否穿刺成功,同时穿刺证推送杆比较柔顺,容易打折,易误穿其他器械或者周围组织。 [0031] In the prior technology does not seal the puncture needle tube, after successful puncture, the contrast can not confirm whether the puncture was successful, and puncture syndrome pushers are compliant and will readily discounted, wear easily mistaken for other instruments or surrounding tissue. 本发明第二种技术方案中,采用可弯曲并具有支撑力的管体,并且还可以在穿刺推送杆中穿装有衬丝,提高穿刺针组件的支撑力,在穿刺的过程中,不容易打折,穿刺更加集中、更加有效,减少误穿其他器械或者周围组织的风险。 A second aspect of the present invention, a flexible and tubular body having a supporting force, and may also be equipped with a wear lining in the puncture wire push rod, to improve the support force of the thrust needle assembly, in the process of puncture is not easy discount, puncture more focused, more effective, reducing the risk of misuse through other instruments or surrounding tissue.

附图说明 BRIEF DESCRIPTION

[0032] 下面将结合附图及实施例对本发明作进一步说明,附图中: [0032] The accompanying drawings and the following embodiments of the present invention is further illustrated drawings in which:

[0033] 图1是本发明实施例1的结构示意图; [0033] FIG. 1 is a schematic structural diagram of an embodiment of the present invention;

[0034] 图2是本发明实施例1的远端结构剖视图; [0034] FIG. 2 is a sectional view of the distal end of the embodiment of Example 1 of the present invention;

[0035] 图3是本发明实施例1球囊导管的结构示意图; [0035] FIG. 3 is a schematic structural diagram of an embodiment of the balloon catheter of the present invention;

[0036] 图4-10是本发明实施例1球囊推送杆横截面的结构示意图; [0036] FIG. 4-10 is a schematic cross section of the pushers embodiment of the present invention, the balloon in Example 1;

[0037] 图11是本发明实施例1穿刺针组件的结构示意图; [0037] FIG. 11 is a schematic structural diagram of an embodiment of the lancet assembly of the present invention;

[0038]图12是本发明实施例1穿刺手柄的剖视图; [0038] FIG. 12 is a sectional view of an embodiment of the present invention, the puncture handle;

[0039]图13-14是本发明实施例1穿刺推送杆横截面的结构示意图; [0039] Figures 13-14 is a schematic cross section of a push rod puncture embodiment of the present invention;

[0040]图15是本发明实施例1穿刺控制机构穿刺推送杆的结构示意图; [0040] FIG. 15 is a schematic structural diagram of a puncturing means puncturing the control of the pushers embodiment of the present invention;

[0041]图16是本发明实施例穿刺控制机构第二种实施方式的结构示意图; [0041] FIG. 16 is a schematic structural diagram of a second embodiment of puncturing the control means of the embodiment of the present invention;

[0042] 图17是图16的轴向剖视图; [0042] FIG 17 is an axial cross-sectional view of FIG 16;

[0043] 图18是图17中JJ剖视图。 [0043] FIG. 18 is a cross-sectional view in FIG. 17 JJ.

具体实施方式 Detailed ways

[0044] 为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图详细说明本发明的具体实施方式。 [0044] For the technical characteristics of the invention, the objects and effects more clearly understood, embodiments of the present invention will now be explained in detail with reference to the drawings.

[0045]以下以主动脉弓部夹层累积左锁骨下动脉为例详细说明,先在右腹股沟附近切口,暴露右股动脉,在加硬导丝的支撑下,通过输送系统经髂总动脉、腹主动脉、胸主动脉、 降主动脉将胸覆膜支架送至主动脉弓部近端,锚定区介于左锁骨下动脉与左颈总动脉之间,部分释放胸主覆膜支架,支架覆膜将左锁骨下动脉完全覆盖,左锁骨下动脉血流被阻断。 [0045] In the following cumulative aortic arch left subclavian artery dissection described in detail as an example, first in the vicinity of the right groin incision, exposing the right femoral artery, the lower support stiffening guide wire, through the delivery system through the iliac artery, abdominal aorta thoracic aorta, the descending aorta to the aortic arch, thoracic stent graft proximal end portion, the anchoring zone between the left common carotid artery and left subclavian artery, the thoracic partially released stent-graft, the stent coating will be left subclavian artery completely covered, the left subclavian artery blood flow is blocked. 经肱动脉近左椎动脉位置穿刺,输送本发明的腔内原位开窗穿刺装置,完成覆膜支架逆行原位开窗,腔内原位开窗穿刺装置详细介绍如下: Brachial artery puncture position near the left vertebral artery, the delivery cavity in situ fenestration puncture device of the present invention, retrograde complete stent-graft fenestration in-situ, in situ fenestration cavity lancing device details are as follows:

[0046]实施例1,本实施例主要解决的技术问题为精确控制穿刺深度、穿刺深度可调并且能锁定穿刺,另外解决穿刺准确的问题,即保证穿刺位置在血管中心。 [0046] Example 1, mainly to solve the technical problem of the present embodiment is the embodiment precise control of penetration depth of the puncture depth is adjustable and can be locked puncturing, puncturing further resolve the problem of inaccurate, i.e., the center of the blood vessel to ensure that the puncture position. 如图1-17所示,一种腔内原位开窗穿刺装置,包括球囊导管100和同轴套装在球囊导管100内的穿刺针组件200; 所述球囊导管100包括带有至少两个腔体的球囊推送杆101、设置在球囊推送杆101远端的球囊囊体102、设置在球囊推送杆101近端的球囊导管座103;所述穿刺针组件200包括穿刺推送杆202、设置在穿刺推送杆202远端的穿刺针头201、穿刺手柄205;所述穿刺手柄205包括近端手柄252和远端手柄251,所述远端手柄251与球囊导管座103固定连接或可拆卸固定连接,所述近端手柄252与穿刺推送杆202连接,所述近端手柄252顺远端手柄251设置,所述远端手柄251与近端手柄252之间设有用于控制穿刺针头201穿刺深度以及锁定穿刺针头201的穿刺控制机构206。 As shown in a cavity in situ fenestration shown in Figure 1-17 lancing apparatus 100 includes a balloon catheter and a coaxial balloon catheter package 100 within the lancet assembly 200; 100 comprising a balloon catheter having at least two cavities balloon push rod 101, the balloon disposed at the distal end of the push rod 101 of the balloon 102 of the balloon, the balloon is provided at the proximal end of the push rod 101 of a balloon catheter hub 103; 200 comprising the lancet assembly puncture pushers 202, 202 provided at the distal end of the puncture push rod piercing needle 201, the puncture handle 205; the puncture handle 205 includes a proximal handle and a distal end 252 of the handle 251, the handle 251 and the distal end of the balloon catheter hub 103 fixed or removably connected fixedly connected to the proximal end of the puncture handle 252 and pushers 202 are connected, the proximal handle 252 is provided along the distal end of the handle 251, the distal end of handle 251 and the proximal handle 252 is provided for between piercing needle 201 penetration depth control and a locking mechanism 201 piercing needle 206 penetration control.

[0047] 如图3所示,球囊导管100主要包括球囊囊体102、球囊推送杆101和球囊导管座103。 [0047] As shown in FIG. 3, the main balloon catheter 100 includes a balloon 102 of the balloon, the balloon push rod 101 and the balloon catheter hub 103. 为了辅助准确穿刺,在分支血管膨胀后,使穿刺点位于分支血管开口的中央位置,优选球囊导管100选择自中心球囊导管100,球囊推送杆101头端在球囊囊体102充盈后位于分支血管的中心位置。 To aid accurate puncture, after expansion the branch vessel, the puncture point in a branch vessel opening central location, the balloon catheter 100 is preferably selected from the center of the balloon catheter 100, balloon 102 after the filling of the balloon to push the balloon end of the rod 101 Centrally located in branch vessel. 自中心是指:球囊囊体102充盈使得所述球囊推送杆101头端充盈位于分支血管的中心位置,这样穿刺的时候更加准确,不易误伤周围组织。 It means from the center: filling the balloon such that the balloon 102 of the balloon end of the push rod 101 located in the center filling branch vessel, so that the piercing time is more accurate, easy to harming the surrounding tissue. 为了保证球囊囊体102 能形成自中心,则所述球囊囊体102为非顺应性或半顺应性球囊囊体102,即所述球囊囊体102采用尼龙弹性体或者聚氨酯弹性体等材料制成的非顺应性或者半顺应性的球囊囊体, 非顺应性或半顺应性球囊囊体102可以避免在扭曲的分支血管内球囊囊体1〇2出现多度变形,从而保持球囊推送杆101头端在球囊囊体102充盈后位于分支血管的中心位置;所述球囊囊体102外形为轴对称结构,优选是锥形、椭圆形或球形,本实施例中采用球形球囊囊体102,球囊囊体102直径略大于分支血管的直径尺寸,当其贴壁之后受到血管的径向压力,逐渐变为椭圆形。 In order to ensure the bladder balloon 102 can be formed from the center, then the balloon is non-compliant balloon 102, or semi-compliant balloon of the balloon 102, the balloon 102 of the balloon i.e. nylon elastomer or polyurethane elastomer material non-compliant or semi-compliant balloon of the balloon made of other materials, non-compliant or semi-compliant balloon of the balloon 102 to avoid deformation of 1〇2 there is more distorted within branch vessel balloon balloon, thereby maintaining the push rod 101 of the balloon end is located at the center position of the branch vessel balloon 102 after filling the balloon; balloon 102 of the balloon structure axisymmetrical shape, preferably conical, spherical or oval, the present embodiment the balloon used in the spherical balloon 102, balloon 102 of the balloon diameter slightly greater than the diameter of branch vessel when subjected to radial pressure vessel after its adherent, and gradually become elliptical. 、 _ , _

[0048] 如图2、3所示,球囊囊体102附着在球囊推送杆1〇1远端处,球囊推送杆101远端的头端位于球囊囊体102外,使得穿刺针组件200能从球囊推送杆1〇1远端的头端伸出。 An outer [0048] 2 and 3, a balloon attached to capsule 102 of the balloon at the distal end of the push rod 1〇1, the push rod head end of the balloon 101 of the balloon distal balloon 102 is positioned such that the needle the head assembly 200 from the distal end of the balloon extends 1〇1 pushers.

[0049] 如图4-10所示,所述球囊推送杆101至少包括一个导丝腔和一个充盈腔111,所述穿刺针头201和穿刺推送杆202穿装在所述导丝腔11〇中。 [0049] As shown in Figure 4-10, the balloon 101 comprises at least one push rod guide wire lumen and a filling chamber 111, 201 and the piercing needle piercing through pushers 202 mounted in the guide wire lumen 11〇 in. 采用多腔管结构的球囊导管100,可以避免现有技术中同轴球囊导管的内管和外管容易发生相对位移的问题,相比同轴结构的球囊导管100,本发明在推送的过程中,球囊囊体102不易变形,具有更好的推送性。 Problems balloon catheter using the multi-lumen tube structure 100, to avoid the prior art balloon catheter coaxial inner and outer tubes relative displacement easily occurs, as compared to the balloon catheter of the coaxial structure 100, according to the present invention in a push process, the balloon 102 of the balloon easily deformed, with better pushability.

[0050] 如图4-10所示,为了使得穿刺针头201和穿刺推送杆202容易在导丝腔11〇中运动, —般的,导丝腔110直径介于0.35-2. Oram之间,可供穿刺针头201和穿刺推送杆202顺畅通过,并且导丝腔110的横截面为圆形、椭圆形等曲面形状,优选圆形。 [0050] shown in Figure 4-10, in order to make the piercing needle 201 and the puncturing stem 202 is easy to push the guidewire lumen 11〇 motion, - like, the diameter of the guide wire lumen 110 is interposed between 0.35 to Oram,. puncture needle for puncturing 201 and push rod 202 through smoothly, and the cross-section of the guidewire lumen 110 is curved circular shape, elliptical shape, preferably circular. 导丝腔丨10可以位于球囊推送杆101的中心位置,也可以偏离中心设置,充盈腔m的数量不作限定,可以设置一个或多个,位置可以在导丝腔110—侧,或者围绕导丝腔110设置,充盈腔111的横截面形状可以是圆形,也可以是根据导丝腔110周围的横截面形状进行排布的任意形状。 Shu guidewire lumen 10 may be located at the center position of the balloon 101 of the push rod may be provided off-center, m is the number of filling the cavity is not limited, and may be provided one or more locations may 110- guidewire lumen side, or turned around wire lumen 110 is provided, the cross-sectional shape of the filling of the cavity 111 may be circular, or may be arranged in arbitrary shape in cross-sectional shape around the guidewire lumen 110. 球囊推送杆101可以是一次性成型形成导丝腔110和充盈腔111的一体结构,也可以是两个或多个管状结构通过粘接或焊接方式固定在一起的结构,同时在两个或多个管状结构为套装或者覆膜以增加它们之间的固定。 The balloon may be a push rod 101 formed integral structure molded disposable guidewire lumen 110 and filling the cavity 111, may be two or more tubular structures by bonding or welding a structure secured together, simultaneously or in two a plurality of tubular structures fixed suit or to increase the coating film therebetween.

[0051] 如图3、4-10所示,所述充盈腔111远端与球囊囊体102联通,充盈腔111近端连接设有用于对球囊囊体102充盈的充盈头104。 [0051] As shown in FIG 3,4-10, filling the cavity 111 with the distal end of the balloon 102 of the balloon Unicom, filling the chamber 111 is connected with a proximal end head 104 for filling the balloon filling balloon 102. 所述充盈头104用于通过充盈腔111对球囊囊体102进行充盈,充盈头104设置在球囊导管座103上,用于与压力栗连接充盈液体。 The filling head 104 of the balloon for filling the balloon 102 by filling space 111, filling head 104 disposed on the balloon catheter hub 103, for filling the liquid Li is connected to the pressure.

[0052] 如图11所示,穿刺针组件200的主要结构包括穿刺推送杆202、穿刺针头201和穿刺手柄205。 [0052] As shown, the main structure of the puncture needle 11 piercing assembly 200 includes a push rod 202, the puncture handle 201 and the puncture needle 205. 为了实现有效地、安全地穿刺,穿刺针头201应至少一个斜面和中空的腔体,其内径应至少大于〇• 35mm,一般的,穿刺针头201长度不超过10臟,本实施例中穿刺针头201采用一次性无菌注射针头。 In order to achieve efficient, safe puncture, the puncture needle 201 should be at least one ramp and a hollow cavity, the inner diameter should be at least greater than square • 35mm, in general, the puncture needle 201 length less than 10 dirty embodiment piercing needle 201 embodiment using disposable sterile syringe needle.

[0053] 所述穿刺针头2〇1和穿刺推送杆2〇2都设有中空封闭腔体,二者的中空封闭腔体联通,中空封闭腔体内径通常不低于0.35mm。 [0053] The puncturing needle and puncturing 2〇1 2〇2 pushers has a hollow closed chamber, both hollow Unicom sealed cavity, the cavity diameter hollow closure usually not less than 0.35mm. 穿刺推送杆202要求既具有一定的柔顺性,顺应血管弯曲,具有较低的轴向压缩和拉伸,以便于在弯曲血管内输送,同时还应具有一定的支撑力,以防止穿刺过程中打折,因此所述穿刺推送杆202为可弯曲并具有支撑力的管体。 Push rod 202 piercing only requires a certain flexibility, adapt to the curved blood vessel, having a lower axial compression and tension, for delivery in a curved vessel, it should also have a certain supporting force to prevent the lancing discounts Therefore the piercing rod 202 is pushed and the bendable tubular body having a supporting force. 能实现穿刺推送杆202具有上述特性的材料和结构有多种,可以采用金属材料或高分子材料制成的具有封闭内腔的管体,例如不锈钢管、钛合金管、聚酰胺或者聚氨酯管等。 Puncturing can be realized and structural material 202 having the above characteristics has a variety of push rods, the tubular body having a closed inner cavity made of a metal material or a polymer material may be employed, such as stainless steel pipe, titanium pipe, a polyamide or a polyurethane tube .

[0054]本实施例中,如图13-15所示,穿刺推送杆202与穿刺针头201相连的部分采用优选为覆膜22〇的弹簧管2M,覆膜220封闭弹簧管221,形成中空封闭腔体,后部为封闭管体。 [0054] In this embodiment, as shown, the piercing of the puncture needle push rod 202 is connected to the spring 201 of the pipe part is preferably 13-15 coating 22〇 of 2M, the coating film 220 closing spring tube 221, forming a closed hollow cavity, a closed rear portion of the tubular body. 穿刺推送杆2〇2中,覆膜22〇的弹簧管221的长度根据实际需要确定,弹簧管221的近端连接中空封闭管体,穿刺推送杆202也可以全部都是覆膜2卻的弹簧管221。 2〇2 puncture pushers, the length of the spring tube 221 22〇 coating film according to the actual needs, the proximal end of the spring tube 221 is connected to the hollow tube is closed, the piercing pushers 202 may be spring are all but 2 film tube 221. 一般的弹簧管221可以由单股丝,也可以由多股丝绕制而成,弹簧管221力学性能可以根据丝的数量、缠绕螺距和多股丝的横截面等参数进行调整;推送杆的内径尺寸不应超过针头的内径尺寸,本实施例中穿刺针头2〇1与穿刺推送杆2〇2通过焊接连接,内外壁平滑过渡;为了能实现注射造影剂, 所述穿刺推送杆2〇2带有中空封闭腔体。 The general spring tube 221 may be made of a single strand, multiple strands of wire may be wound from, the mechanical properties of the spring tube 221 may be in accordance with the number of filaments, winding pitch, and the parameters of the cross-section of a multi-strand like adjustment; push lever should not exceed the inner diameter dimension of the inner diameter of the needle, the puncture needle 2〇1 2〇2 embodiment is connected by welding to the puncture pushers present embodiment, smooth transition outer wall; contrast agent is injected in order to achieve the piercing pushers 2〇2 with a hollow closed chamber. 本实施例覆膜220的材料可以采用聚四氟乙烯、聚对苯二甲酸乙二醇酯、聚酰胺或者聚氨酯等等材料制成,通过热熔或者热缩在弹簧管^21 上,使穿刺针头2〇1和穿刺推送杆202封闭密封,当穿刺成功后,通过穿刺推送杆2〇2近端向穿刺推送杆202的中空封闭腔体中注射造影剂,造影剂到达穿刺针头201,在荧光透视设备下确认穿刺针头201已经处于主体血管内,同时覆膜220有利于减少弹簧管221轴向的拉伸和压缩,提高推送杆穿刺支撑力。 Example coating material 220 of the present embodiment may be employed as polytetrafluoroethylene, polyethylene terephthalate, polyurethane or the like made of a polyamide material by a hot melt or heat shrinkable tube ^ on the spring 21, the puncture 2〇1 puncture needle and push rod seal 202 is closed, when the puncture is successful, the cavity 202 of hollow closure injection of a contrast agent, the contrast agent reaches the puncturing needle puncturing pushers 201 to push the proximal end of the piercing rod 2〇2, fluorescent confirmed under fluoroscopic apparatus 201 has puncture needle in a blood vessel within the body, while the coating film 220 helps to reduce the axial spring tube 221 tension and compression, to improve puncture force of push rod support.

[0055] 如图2、3所示,所述穿刺推送杆202中穿装有用于加强穿刺推送杆202支撑力的衬丝203。 [0055] 2 and 3, the push rod 202 through the puncture with the puncture liner for reinforcing bars 202 push the wire 203 of the supporting force. 衬丝203用于穿刺推送杆202在穿刺过程中提供支撑力,防止穿刺推送杆202因支撑力不足而打折,造成穿刺不成功或者误伤周围组织,衬丝203包括一个弹性的丝杆和一个可与穿刺手柄205装配的衬丝座232组成,本实施例中衬丝203的丝杆为镍钛丝,衬丝座232为公鲁尔,衬丝203的头端经过圆头,衬丝203插入穿刺针头201以及穿刺推送杆202的内腔,其头端处于穿刺针头201位置,且不露出穿刺针头201斜面位置,公鲁尔与穿刺手柄205的末端母鲁尔装配在一起。 Wire liner 203 pushers for puncturing 202 provides a supporting force during lancing, the push rod 202 to prevent puncture force due to lack of support discounts, resulting in unsuccessful piercing or harming the surrounding tissue, the liner comprising a flexible wire 203 and a lead screw lining the puncture with wire seats 232 for fitting the handle 205, the present embodiment lining wire screw 203 is nickel-titanium wire, wire seats lining of the male luer 232, the head end of the pad 203 through wire round, wire 203 is inserted into the liner piercing needle piercing pushers 201 and lumen 202 in head end 201 of the needle piercing position, piercing needle 201 is not exposed bevel position, the puncture handle tip male luer 205 of the female luer fitting together.

[0056] 所述近端手柄252顺远端手柄轴向移动,即所述近端手柄252穿装在所述远端手柄251内并顺远端手柄251轴向移动,或者所述近端手柄252在所述远端手柄251外并顺远端手柄251轴向移动,所述穿刺控制机构206包括设置在近端手柄252与远端手柄251之间的最大行程控制组件260和穿刺锁定组件261。 [0056] The proximal end of the handle 252 to move axially along the distal end of the handle, the proximal handle 252 that is reeved within the distal handle 251 and the handle 251 to move axially along the distal end, said proximal end or handle 252 in the distal end of the outer handle 251 and the handle 251 to move axially along the distal end of the piercing mechanism 206 includes a lock control the maximum stroke of the control assembly 251 between the proximal handle and the distal end 252 of the handle assembly 260 and puncturing 261 . 通过调整近端手柄252与远端手柄251的相对位置, 进而实现穿刺针针头伸出球囊导管100头端的长度,通过调整限位的位置,实现穿刺深度可调,同时防止近端手柄252回撤。 By adjusting the relative position of the distal end of the handle 252 and the proximal handle 251, so as to realize the projecting length of needle puncture needle tip of the balloon catheter 100 by adjusting the position of the limit, to achieve an adjustable penetration depth, while preventing the proximal handle 252 back withdraw. 穿刺控制机构206有多种结构,以下分别说明: Penetration control mechanism 206 has various structures, the following are described:

[0057]如图I2所示为穿刺控制机构206的第一种实施方式,本实施方式可以快速驱动实现穿刺,并实现定量精确穿刺。 [0057] As shown in FIG I2 puncture the control means 206 of the first embodiment, this embodiment can quickly drive the piercing implement, and to achieve accurate quantitative puncture. 所述最大行程控制组件260包括设置在近端手柄252上或远端手柄251上的行程槽260a,对应的远端手柄251或近端手柄252上设有限位块260b;所述行程槽260a顺穿刺推送杆2〇2轴向设置,所述限位块260b配合在行程槽260a中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度,最大深度是根据血管直径确定,通常不超过40mm。 The control assembly 260 includes a maximum travel or stroke of the grooves on the distal end 260a of the handle 251, the handle 251 corresponding to the distal end stopper 260b is provided on the proximal end or handle 252 is provided on the proximal end of handle 252; 260a along the groove stroke a push rod axially disposed 2〇2 puncture, the stopper 260b slidably fitted in the groove 260a of the stroke and the maximum sliding distance of the puncture needle is allowed maximum depth, the maximum depth is determined according to the diameter of a blood vessel, usually not more than 40mm. 行程槽26〇a的横向宽度稍大于限位块260b的横向宽度,二者间隙配合或滑动配合。 Lateral width slightly larger than the stroke in the stopper groove 26〇a 260b lateral width of both sliding fit or clearance fit. [0058] 所述穿刺锁定组件261为近端手柄252控制部上设置多个定位锁定槽261a,对应的远端手柄251上设有弹性锁定件261b,所述弹性锁定件261b弹性顶压在定位锁定槽261a中将穿刺针头位置锁定,在外力驱动近端手柄252,使得弹性锁定件261b在不同的定位锁定槽26la之间滑动。 [0058] The locking assembly 261 is provided a plurality of puncturing the lock groove 261a is positioned on the proximal end portion of the control handle 252, an elastic locking member 261b corresponding to the distal end of the handle 251, the elastic locking member 261b elastically pressed against the positioning the lock groove 261a in the puncture needle locking position, the driving force in the proximal handle 252, such that sliding between the resilient locking member 261b in the lock groove 26la different positioning. 定位锁定槽%la从远端至近端在近端手柄252上间隔均匀设置多个,设置数量跟穿刺所需深度和调节所需距离有关。 % La locking groove positioned from the distal end to the proximal end of the proximal handle 252 is provided a plurality of evenly spaced, with the number to set the desired distance related to the desired depth and lancing adjustment. 穿刺锁定组件261的设置是为了在穿刺后对穿刺针组件进行锁定,并且通过调整定位锁定槽261a与弹性锁定件261b的相互位置,来调整穿刺深度。 Puncturing locking assembly 261 is provided in order to lock needle assembly after the puncture, and by adjusting the positioning groove 261a and the resilient locking member locking the mutual position of 261b, to adjust the lancing depth. 穿刺前调整弹性锁定件261b的位置,弹性锁定件261b配合在越靠近远端的定位锁定槽2eia中,则穿刺深度越大,反之,穿刺深度小。 Before piercing the resilient locking position 261b of the adjustment member, the elastic locking member 261b is positioned closer to the distal end fitted in the locking groove 2eia, the greater the depth of the puncture, whereas the small penetration depth. 近端手柄252上设有标尺,穿刺深度是几个固定值,用于显示并调节穿刺深度,实现定量穿刺。 A proximal handle 252 is provided on the scale, the piercing depth of several values, for displaying and adjusting the penetration depth, to achieve quantitative puncture.

[0059]定位锁定槽26la为能滑进滑出的曲面槽,优选为半球形槽,定位锁定槽261a的深度以有利于锁定近端手柄252为准,不作具体尺寸要求。 [0059] positioned to the lock groove can be slid in and out 26la curved grooves, preferably hemispherical grooves, the depth of the locking groove 261a positioned to facilitate locking of the proximal handle 252 subject, specific dimensions is not required. 弹性锁定件261b有多种结构,可以直接是整体的弹性结构件,也可以是前端设有锁定头266,后部连接弹性体267,弹性体267 可以选择弹簧,锁定头266固定在弹簧上,弹簧伸张将锁定头266压紧在定位锁定槽261a中, 通过轴向外力,锁定头266受定位锁定槽261a曲面槽壁顶压回缩,从定位锁定槽261a中脱出,沿近端手柄252滑动至下一个定位锁定槽261a。 The elastic locking member 261b has a variety of structures can be directly integral resilient structure, the distal end may be provided with a locking head 266, the rear portion 267 connected to the elastic body, the elastic body 267 can select spring, the locking head 266 is fixed on the spring, stretching the spring pressing the locking head 266 locked in the positioning groove 261a by the axial force, the locking head 266 locked by the positioning groove 261a pressed against the groove wall surface is retracted, released from the groove 261a is positioned in the locking slide 252 in the proximal handle positioned next to the lock groove 261a. 弹性体267外设有压装螺帽268,压装螺帽268用于调节弹簧弹力以及锁定穿刺针头位置。 Outside the elastic body 267 press-fit the nut 268, the nut 268 for adjusting the press-fitting force of a spring and a locking position piercing needle.

[0060]如图16-18所示,为穿刺控制机构2〇6的第二种实施方式,本实施方式穿刺深度是连续可调的,可以实现更加精确的穿刺。 [0060] 16-18, the control means for the piercing of the second embodiment 2〇6 embodiment, the present embodiment is continuously adjustable depth of puncturing, can be realized more precise puncture. 所述穿刺锁定组件261包括限位在远端手柄251上的驱动套269,对应驱动套269的近端手柄252上设有滑动块268,所述滑动块268与驱动套269通过螺纹啮合,旋转驱动套269驱动滑动块268沿穿刺推送杆202轴向滑动。 The locking assembly 261 includes a piercing stopper on the distal end 269 of the handle 251 of the drive sleeve, the drive sleeve is provided with a corresponding slide block 268 on the proximal end of the handle 252,269, the sliding block 268 and the drive sleeve 269 by a threaded engagement, rotation the drive sleeve 269 drives the slide block 268 along the rod 202 axially slidable push the piercing. 驱动套269内壁设有内螺纹269a,与滑动块268顶部设置的外螺纹268a啮合。 The inner wall of the drive sleeve 269 is provided with an internal thread 269a, 268a slidably engaged with external threads 268 provided in the top block. 驱动套269的内螺纹269a长度不低于最大穿刺深度。 269a internally threaded drive sleeve length 269 is not less than the maximum penetration depth.

[0061] 所述最大行程控制组件260包括所述远端手柄251上设有的行程槽260a,所述行程槽260a沿穿刺推送杆202轴向设置,行程槽260a内外贯通使得所述滑动块268穿过行程槽260a与驱动套269螺纹啮合,所述滑动块268配合在行程槽260a中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度。 [0061] The control assembly 260 includes a maximum travel stroke of the groove provided on the distal end of handle 251 260a, 260a of the grooves along the puncture stroke push rod 202 axially, through the groove 260a so that the inner and outer stroke of the slide block 268 travel through the groove 260a and the drive sleeve 269 threaded engagement, said sliding block 268 slidably fitted in the groove 260a of the stroke and the maximum sliding distance of the maximum depth of the puncture needle is allowed. 行程槽260a的横向宽度稍大于限位块260b的横向宽度,二者间隙配合或滑动配合。 Lateral width slightly larger than the stroke of the groove 260a in the lateral width stopper 260b, the two clearance fit or sliding fit. 行程槽260a—方面用于控制穿刺深度,另一方面用于限制滑动块268的转动,防止在旋转驱动套269时,滑动块268转动。 Stroke groove 260a- aspect for controlling penetration depth, on the other hand for limiting the rotation of the slider 268, preventing the drive sleeve 269 rotates, the slide block 268 is rotated. 滑动块268与近端手柄252可以一体结构,也可以二者固定连接在一起。 The slide block 268 and the proximal handle 252 may be an integral structure, the two may be secured together.

[0062] 实施过程:在分支血管被覆盖之前,使用肝素或者生理盐水分别冲洗原位开窗器械包组件,并对整套器械排气,经皮穿刺沿着J型导丝,通过鞘管建立靶位置与穿刺点之间的输送通道,交换球囊导丝(0.014”或者0.018”)。 [0062] The process: before the branch vessels are covered, respectively, the use of heparin or saline flush situ fenestration instrument package assembly, and exhaust equipment package, percutaneous along J-guide wire, through the sheath to establish target transfer passage between the position of the puncture site, the guidewire exchange balloon (0.014 "or 0.018"). 然后在体外将穿刺针套进球囊导管100内腔,并使穿刺针组件200远端手柄251的头端与球囊导管100导丝腔110出口相连接,确保穿刺针头201回撤至球囊导管100远端内,沿着导丝,向前推送,直至自球囊导管100TIP端到达外鞘管TIP端;后撤外鞘管,使球囊全伸出外鞘管TIP端,从充盈口充盈球囊,使其紧贴左锁骨下动脉血管壁; In vitro then the puncture needle sheath 100 lumen balloon catheter goal, and the puncture needle 200 distal end of handle assembly 251 with the head end of the balloon catheter guidewire lumen 100 is connected to outlet 110, 201 to ensure that the puncture needle retraced to balloon the distal end of the catheter 100, along the guide wire, pushing forward, since the balloon catheter until the outer sheath reaches the end 100TIP TIP end; retreat the outer sheath, the balloon is fully extended end of the outer sheath TIP, filling from the filling port balloon firmly against the left subclavian artery walls;

[0063] 在医学影像的辅助下,确定需要的穿刺深度,调节远端手柄251的行程限位,确定近端手柄252与远端手柄251可驱动的行程,后撤导丝;快速的驱动近端手柄252,穿刺针将刺破支架覆膜,通过锁紧螺母固定远端手柄251和近端手柄252的相对位置以保持穿刺针位置,撤出衬丝203,通过穿刺推送杆202的腔体注射造影剂,在荧光透视设备下,确认穿刺针头201是否己经到达主动脉内;沿着穿刺针头201和穿刺推送杆202的腔体推送导丝至主动脉,后撤穿刺针头201,取出穿刺针组件200,泄压球囊囊体102,然后取出球囊导管100,建立将外鞘管和导丝留置于原位。 [0063] with the aid of medical imaging, the required penetration depth is determined, the distal end of the handle adjusting travel limit 251 is determined 252 and distal proximal handle grip 251 can drive stroke retreat guidewire; fast drive near end of the handle 252, the needle will pierce the film holder, the relative position by a lock nut 251 and the proximal end of the distal end of the handle to hold the handle 252 of the puncture needle position, withdrawal of the wire liner 203, the cavity 202 by puncturing the push rod injection of contrast agent under fluoroscopy apparatus, to confirm whether the puncture needle 201 has reached within the aorta; along the piercing needle 201 and the puncturing push rod chamber 202 to push the guide wire aorta, retreat piercing needle 201, the puncture removed needle assembly 200, pressure relief balloon balloon 102, the balloon catheter 100 is then removed, and the establishment of the outer sheath indwelling guidewire in situ. 利用此通道将扩张球囊输送至穿刺点逐步扩张,实现原位开窗,在医学影像的辅助下确定开窗大小,交换导丝并留置原位,退出外鞘管,为随后的支架植入做准备。 This use of the dilatation balloon delivery passage to gradually expand the puncture point, window-situ, the window size is determined with the aid of medical imaging, and left in situ guidewire exchange, exit the outer sheath for subsequent stent implantation prepare for.

[0064] 实施例2,本实施例主要解决的技术问题是:穿刺推送杆202不容易打折、穿刺更加集中和有效的问题。 [0064] Example 2, the present embodiment is mainly to solve the technical problem: not easily puncture discount pushers 202, more focused and effective puncture problems.

[0065] —种腔内原位开窗穿刺装置,包括球囊导管100和同轴套装在球囊导管100内的穿刺针组件200;所述球囊导管100包括带有至少两个腔体的球囊推送杆101、设置在球囊推送杆101远端的球囊囊体102、设置在球囊推送杆101近端的球囊导管座103;所述穿刺针组件200包括穿刺推送杆202、设置在穿刺推送杆202远端的穿刺针头201、穿刺手柄205;所述穿刺推送杆202为可弯曲并具有支撑力的管体,所述穿刺推送杆202中穿装有用于加强穿刺推送杆202支撑力的衬丝203。 [0065] - seed cavity situ fenestration lancing apparatus 100 includes a balloon catheter and a coaxial set 200 in the puncture needle assembly 100 within the balloon catheter; 100 comprising a balloon catheter having at least two cavities the push rod 101 of the balloon, the balloon disposed at the distal end of the push rod 101 of the balloon 102 of the balloon, is provided at the proximal end of the balloon 101 of the balloon catheter hub pushers 103; the lancet assembly 200 includes a push rod 202 piercing, puncture needle disposed at the distal end 202 of the push rod 201, the puncture handle 205; push the piercing rod 202 is bendable and has support tube, said push rod 202 through the piercing with the piercing pushers 202 for reinforcing the wire liner 203 supporting force. 上述部件的具体结构同实施例1。 Specific configuration of the member in Example 1.

[0066] 其中球囊导管100结构可以同实施例1 一致,包括球囊推送杆101和球囊囊体102, 但是也可以采用现有技术中的球囊囊体102,其余结构同实施例1在此不再赘述。 [0066] wherein the balloon catheter structure 100 may be consistent with the Example 1 embodiment, the push rod 101 includes a balloon and the balloon during balloon 102, but may also be employed in the prior art balloon balloon 102, with the remaining structure of Example 1 not discussed here.

[0067] 穿刺推送杆202、穿刺针头201、衬丝203的结构也同实施例1,在此不再赘述。 [0067] The push rod 202 puncturing, the puncture needle 201, the wire 203 is also the structure of the liner in Example 1, are not repeated here.

[0068] 相比实施例1,穿刺控制机构206为选择性结构,即可以有穿刺控制机构206,也可以没有。 [0068] Example 1 as compared to the piercing mechanism 206 to selectively control structure, i.e., control mechanism 206 may puncture, or may not. 远端手柄251和近端手柄252可以合二为一成为一个可以驱动穿刺针组件进行穿刺的部件。 The distal end of the handle 251 and the proximal handle 252 may be combined to drive a lancet assembly for puncturing member.

Claims (13)

1. 一种腔内原位开窗穿刺装置,其特征在于:包括球囊导管和同轴套装在球囊导管内的穿刺针组件; 所述球囊导管包括带有至少两个腔体的球囊推送杆、设置在球囊推送杆远端的球囊囊体、设置在球囊推送杆近端的球囊导管座; 所述穿刺针组件包括穿刺推送杆、设置在穿刺推送杆远端的穿刺针头、穿刺手柄; 所述穿刺手柄包括近端手柄和远端手柄,所述远端手柄与球囊导管座固定连接或可拆卸固定连接,所述近端手柄与穿刺推送杆连接,所述近端手柄顺远端手柄设置,所述远端手柄与近端手柄之间设有用于控制穿刺针穿刺深度以及锁定穿刺针穿刺深度的穿刺控制机构。 An in-situ chamber windowing lancing device comprising: a balloon catheter and a coaxial needle assembly package in the balloon catheter; the balloon catheter comprises a ball having at least two cavities push rod balloon, the balloon disposed at the distal end of the push rod balloon is a balloon, the balloon is provided at the proximal end of the push rod balloon catheter hub; puncturing the puncture needle assembly comprising a push rod, the push rod disposed at the distal end of the piercing piercing needle, the puncture handle; the puncture handle comprises a proximal handle and a distal end of the handle, the handle and the distal end of the balloon catheter hub fixedly attached or removably fixedly connected to the proximal end of the push rod is connected to the puncture handle, the a proximal handle disposed along a distal end of the handle, the distal end of the piercing means is provided between the control handle and the proximal end of the handle for controlling the puncture needle puncture depth, and the locking of the needle penetration depth.
2. 根据权利要求1所述的腔内原位开窗穿刺装置,其特征在于,所述近端手柄顺远端手柄轴向移动,所述穿刺控制机构包括设置在近端手柄与远端手柄之间的最大行程控制组件和穿刺深度锁定组件。 2. The in-situ chamber according to claim 1, said puncturing device window, wherein the proximal end of the handle to move axially along the distal end of the handle, the piercing means comprises a control handle disposed at a proximal end and a distal end of the handle the maximum stroke between the control assembly and the penetration depth of the locking assembly.
3. 根据权利要求2所述的腔内原位开窗穿刺装置,其特征在于,所述最大行程控制组件包括设置在近端手柄上或远端手柄上的行程槽,对应的远端手柄或近端手柄上设有限位块;所述行程槽顺穿刺推送杆轴向设置,所述限位块配合在行程槽中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度。 According to claim 2, wherein the cavity in situ fenestration puncture device, characterized in that the maximum stroke of the control assembly includes a handle disposed on the proximal end of the stroke or the groove on the distal end of the handle, the distal end of the handle or corresponding a handle provided on the proximal end of the stopper; cis puncture the stroke groove disposed axially pushers, the stop block and slidably fitted in the sliding groove travel a maximum distance allowed for the maximum depth of the puncture needle.
4. 根据权利要求2所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺锁定组件为近端手柄控制部上设置多个定位锁定槽,对应的远端手柄上设有弹性锁定件,所述弹性锁定件弹性顶压在定位锁定槽中将穿刺针位置锁定,在外力驱动近端手柄,使得弹性锁定件在不同的定位锁定槽之间滑动。 According to claim 2, wherein the cavity in situ fenestration puncture device, wherein the piercing assembly is provided a plurality of locking grooves positioned on the proximal end of the handle lock control unit, is provided on the respective distal end of the resilient handle a locking member, said resilient locking member positioned elastically pressed against the lock groove to lock the position of the puncture needle, the driving force in the proximal end of the handle, the resilient locking member such that the positioning of the slide between the different locking groove.
5. 根据权利要求2所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺锁定组件包括限位在远端手柄上的驱动套,对应驱动套的近端手柄上设有滑动块,所述滑动块与驱动套通过螺纹啮合,旋转驱动套驱动滑动块沿穿刺推送杆轴向滑动。 The in-situ chamber according to claim 2 windowing puncturing device, wherein the locking assembly includes a stopper piercing distal end of the handle on the drive sleeve, the drive sleeve corresponding to the proximal end of the handle of a slide block, the sliding sleeve by means of threaded engagement with the drive block, the rotary drive sleeve driving the slider to slide axially along the puncture pushers.
6. 根据权利要求5所述的腔内原位开窗穿刺装置,其特征在于,所述最大行程控制组件包括所述远端手柄上设有的行程槽,所述行程槽沿穿刺推送杆轴向设置,且所述滑动块穿过行程槽与驱动套螺纹啮合,所述滑动块配合在行程槽中滑动并且其滑动最大距离为允许穿刺针穿刺的最大深度。 6. The in-situ chamber according to claim 5 windowing puncturing device, characterized in that the maximum travel stroke of the control assembly comprises a groove provided on the distal end of said handle, said groove along the puncture stroke push lever shaft the setting and the stroke of the slide block through the sleeve threaded engagement with the drive slot, the slider fitted in the sliding groove and the sliding stroke of the maximum distance allowed maximum depth of the puncture needle.
7. 根据权利要求1-6任意一项所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺针头和穿刺推送杆都设有中空封闭腔体,二者的中空封闭腔体联通。 7. The in-situ chamber according to any one of claims 1-6 windowing puncturing device, characterized in that the piercing needle and the hollow puncture pushers have a sealed cavity, the cavity between the two hollow closure Unicom.
8. 根据权利要求7所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺推送杆为可弯曲并具有支撑力的管体。 Situ chamber according to claim 7, wherein said windowing puncture device, wherein the piercing pushers bendable and has support tube.
9. 根据权利要求8所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺推送杆设有覆膜的中空封闭腔体。 According to claim 8, wherein said cavity situ fenestration puncture device, characterized in that the piercing rod is provided with a hollow push closed chamber coating.
10. 根据权利要求7所述的腔内原位开窗穿刺装置,其特征在于,所述穿刺推送杆的中空封闭腔体中穿装有用于加强穿刺推送杆支撑力的衬丝。 10. The in-situ chamber according to claim 7 windowing puncturing device, wherein the hollow puncture wire liner closed chamber provided with a push rod through the puncture pushers for reinforcing the supporting force.
11. 根据权利要求1-6任意一项所述的腔内原位开窗穿刺装置,其特征在于,所述球囊推送杆至少包括一个导丝腔和一个充盈腔,所述穿刺针头和穿刺推送杆穿装在所述导丝腔中,所述充盈腔远端与球囊囊体联通,充盈腔近端连接有用于对球囊囊体充盈的充盈头。 11. The in-situ chamber of any one of claims 1-6 windowing puncture device, characterized in that the balloon comprises at least one push rod guide wire lumen and a filling chamber, and puncturing the puncture needle a push rod mounted through the guidewire lumen, the distal end of the balloon cavity filling balloon Unicom, filling the cavity with a proximal end connected to the balloon for filling the balloon filling head.
12. 根据权利要求1-6任意一项所述的腔内原位开窗穿刺装置,其特征在于,所述球囊囊体为非顺应性或半顺应性球囊囊体。 12. A chamber according to any one of claims 1-6 in situ fenestration puncturing device, wherein the balloon is non-compliant balloon or balloon semi-compliant balloon.
13.—种胜内原位开窗穿刺装置,其特征在于:包括球囊导管和同轴套装在球囊导管内的穿刺针组件; ' 所述球囊导管包括带有至少两个腔体的球囊推送杆、设置在球囊推送杆远端的球囊囊体、设置在球囊推送杆近端的球囊导管座; 所述穿刺针组件包括穿刺推送杆、设置在穿刺推送杆远端的穿刺针头、穿刺手柄; 所述穿刺推送杆为可弯曲并具有支撑力的管体,所述穿刺推送杆中穿装有用于加强穿刺推送杆支撑力的衬丝。 13.- species in situ within the window win lancing device comprising: a balloon catheter and a coaxial needle assembly package in the balloon catheter; 'the balloon catheter comprises at least two cavities having balloon push rod, the push rod disposed at the distal end of the balloon of the balloon capsule, pushers provided in the proximal end of the balloon of the balloon catheter hub; puncturing the puncture needle assembly comprising a push rod, the push rod disposed at the distal end of the piercing the puncture needle, the puncture handle; push the piercing rod is bendable and has support tube, the piercing wire through liner with pushers for puncturing strengthen the supporting force of the push rod.
CN201710179335.8A 2017-03-23 2017-03-23 Device for intracavity in-situ fenestration and puncture CN106963516A (en)

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* Cited by examiner, † Cited by third party
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US5147316A (en) * 1990-11-19 1992-09-15 Castillenti Thomas A Laparoscopic trocar with self-locking port sleeve
CN2261234Y (en) * 1996-10-25 1997-09-03 白守国 Marrow puncture needle
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CN101903061A (en) * 2007-12-18 2010-12-01 住友电木株式会社;大石英人 Guide tube having balloons for puncture
CN103040502A (en) * 2012-12-04 2013-04-17 中国人民解放军第三军医大学第三附属医院 Balloon needle for stent orthotopic fenestration
CN103142336A (en) * 2013-03-29 2013-06-12 孙思予 Integrated bracket embedder
CN105286957A (en) * 2015-10-30 2016-02-03 杭州市第一人民医院 Puncture needle assembly used for trigeminal gasserian ganglion oppression surgery
JP2016168228A (en) * 2015-03-13 2016-09-23 オリンパス株式会社 Endoscope puncture device
CN205626040U (en) * 2015-10-30 2016-10-12 杭州市第人民医院 Be arranged in half month festival of trigeminal nerve to oppress art pjncture needle subassembly

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5147316A (en) * 1990-11-19 1992-09-15 Castillenti Thomas A Laparoscopic trocar with self-locking port sleeve
CN2261234Y (en) * 1996-10-25 1997-09-03 白守国 Marrow puncture needle
US20090030380A1 (en) * 2004-12-08 2009-01-29 Xlumena, Inc. Method and Apparatus for Performing Needle Guided Interventions
CN101903061A (en) * 2007-12-18 2010-12-01 住友电木株式会社;大石英人 Guide tube having balloons for puncture
CN201578402U (en) * 2009-11-16 2010-09-15 南京微创医学科技有限公司 Support introducer capable of precisely positioning
CN103040502A (en) * 2012-12-04 2013-04-17 中国人民解放军第三军医大学第三附属医院 Balloon needle for stent orthotopic fenestration
CN103142336A (en) * 2013-03-29 2013-06-12 孙思予 Integrated bracket embedder
JP2016168228A (en) * 2015-03-13 2016-09-23 オリンパス株式会社 Endoscope puncture device
CN105286957A (en) * 2015-10-30 2016-02-03 杭州市第一人民医院 Puncture needle assembly used for trigeminal gasserian ganglion oppression surgery
CN205626040U (en) * 2015-10-30 2016-10-12 杭州市第人民医院 Be arranged in half month festival of trigeminal nerve to oppress art pjncture needle subassembly

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