• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    INTRODUCING SHEATH ASSEMBLY WITH A LOCKING DILATOR An introducer assem- bly includes a valve having a first end and an opposing second end; a sheath rigidly attached and extending axially from one of the first and second ends of the valve, an expander extending through the valve and the sheath; and a rotary locking button between the locked and unlocked positions to axially release the tool in relation to the sheath without causing corresponding rotation of the tool with it.
    公开号:BR112014011706B1
    申请号:R112014011706-3
    申请日:2012-11-16
    公开日:2021-02-09
    发明作者:Brian C. Holm；Shane P. Rogers
    申请人:W. L. Gore & Associates, Inc.；
    IPC主号:
    专利说明:

    CROSS REFERENCE FOR RELATED APPLICATIONS
    [0001] This application claims priority US Provisional Application Ser. No. 61 / 560,638, which was filed on November 16, 2011 and is incorporated herein by reference in its entirety. FIELD OF THE INVENTION
    [0002] The invention relates to an introducer set of medical procedures and, more particularly, a closing mechanism for axially removable closing a sheath and a surgical implement inserted through the sheath. DISCUSSION
    [0003] Introducer sets are used in a wide variety of minimally invasive and conventional surgical procedures, such as endoluminal delivery of surgical instruments. Introducer sets typically include an introducer sheath and valve to control leakage when accessing the introducer with surgical instruments, such as stent devices, dilators, guide wires, etc. Introducer valves generally depend on contact between a resilient elastomeric sealing body and a surgical implement inserted through the introducer valve to form a seal that is watertight to the desired fluid. It remains desirable to provide a locking mechanism for a surgical introducer and implement without interrupting the seal between the valve and surgical introducer to implement. BRIEF DESCRIPTION OF THE DRAWINGS
    [0004] The accompanying drawings are included to provide a further understanding of the invention and are incorporated and form a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.
    [0005] Figure 1 is a side elevation view of an introducer assembly according to the various embodiments;
    [0006] Figure 2 is a cross-sectional view of an introducer assembly according to the various embodiments;
    [0007] Figure 3 is an enlarged cross-sectional view of an introducer assembly according to the various embodiments;
    [0008] Figure 4 is an exploded perspective view of a closing mechanism according to the various embodiments;
    [0009] Figure 5 is a perspective view of a closing mechanism according to the various embodiments shown in an unlocked position; and
    [0010] Figure 6 is a perspective view of a closing mechanism according to the various embodiments shown in the locked position. DETAILED DESCRIPTION OF THE ILLUSTRATED WAYS OF IMPLEMENTATION
    [0011] An introducer set, in accordance with various embodiments, is disclosed herein, which includes a closing mechanism for loosening the closure axially from the introducer sheath and a surgical implement or tool inserted through the introducer sheath set, such as dilators, endoprostheses, endoscopes and the like. The introducer sheath assembly may include a sheath, and a leak prevention valve when inserting an instrument through the sheath. Examples and detailed description of an introduction sheath and valve assembly are described in the copending US Patent Application Publication 2009/0306598, the contents of which are hereby incorporated by reference in their entirety.
    [0012] With reference to Figure 1, an introducer sheath set according to the various embodiments is shown and generally indicated at 10. The introducer sheath set 10 includes a tubular sheath 200, adapted to receive an elongated tool through itself. In the figures, a tool 100 is shown illustratively as an dilator, although it should be readily noted that the tool can be any instrument or delivery device through the sheath, such as an endoscope or a stent graft. The introducer sheath assembly 10 can include a valve 400 to prevent leakage during insertion of tool 100 through sheath 200. More specifically, sheath 200 can be rigidly attached to one end 410 of valve 400. Sheath 200 and an inner tube Resilient valve 430 of valve 400 can generally be coaxially aligned to receive tool 100 therethrough. In various embodiments, described in more detail below, the introducer sheath assembly 10 includes a closing mechanism 300 that allows selective closing of the tool 100 to the sheath 200 and the valve 400.
    [0013] With reference to Figures 2 and 3, a closing mechanism 300 is disposed on an end 420 of the valve 400 opposite the sheath 200. The closing mechanism 300 is operable between a locked and unlocked position to allow the selective locking of the tool 100 for sheath 200 and valve 400. In various embodiments, closing mechanism 300 includes a closing button 500 that can rotate between locked and unlocked positions to axially release the locking of tool 100 to sheath 200 or , more specifically, for valve 400 without causing the corresponding rotation of tool 100 relative to valve 400. In various embodiments, tool 100 includes a hub 102. Hub 102 includes an annular bearing surface 104. Hub 102 includes surfaces extending radially outwardly from position 106 that are axially spaced from each other over annular surface 104. Hub 102 also includes a the annular portion 110 axially adjacent to the support surface 104. The annular portion 110 protrudes axially to facilitate the alignment of the tool 100 as the tool 100 is inserted through valve 400 and the sheath 200. In other embodiments, the locking button can be movable in other directions, such as axial, in relation to the hub.
    [0014] The closing button 500 includes at least one rib 520 that extends radially that engages the annular supporting surface 104 of the hub 102, thus, generally radially to position the closing button 500 in relation to the hub 102. The rib 520 it also engages axially spaced from the locating surfaces 106, thereby axially positioning and restricting the closing button 500 relative to the hub 102. The closing button 500 and a hub 102 are therefore, in general, axially constrained with respect to the other, but they are also free to rotate in relation to each other. Thus, as described below, the clinician can selectively rotate the locking button 500 relative to the hub 102 to lock or unlock the locking mechanism 300 and not cause unwanted rotation of the tool 100 relative to the sheath 200, the valve 400 and / or the vasculature.
    [0015] The introducer sheath assembly 10 includes a rear fitting 600 rigidly attached to the end 410 of the valve 400 opposite the sheath 200. More specifically, the rear fitting includes a conical ring back portion 602. A resilient lip or ring (not shown) it can be positioned along a groove 604 that extends around the ring portion 602. The ring can be formed from silicone or other suitable resilient sealing material. In conjunction with the valve arrangement, the tapered portion 602 of the rear fitting 600 extends into the tube 430 of the valve 400. Insertion of the conical portion 602 into the inner tube 430 during assembly causes the ring to stop. engage and move radially or elastically deform the inner tube 430, thus forming a seal with the same fluid. The rear fitting may also include a closing device, such as a separator or burr that extends through an opening or recess, to ensure its orientation with respect to the valve, once installed inside.
    [0016] The closing mechanism 300 includes a locking tab 310 which generally extends axially from a surface end 510 of the locking button 500. A protrusion 320 extends generally radially from one end of the locking tab 310 and is axially spaced from the surface of the end 510 of the closing button 500. Alternatively, the closing mechanism may include more than one locking tab. In Figure 4, for example, a pair of locking tabs 310 extends from generally opposite sides of the end surface 510 of the closure button 500.
    [0017] The closing mechanism 300 includes a groove that extends axially 330 formed in the rear socket 600 to accommodate passing each locking tab 310 through it as the closing button 500 and the rear socket 600 are positioned towards each other in the direction the other axially. The closing mechanism 300 includes an annular recess or notch 340 formed in the rear housing 600 which intersects with and extends rotationally from the groove 330 to accommodate the protrusion 320, as the closing button 500 is rotated in relation to the rear housing 600 , for example, by an assembly during the manufacture of the assembly or by a clinician when the actuation of the closing mechanism 300 to block or release the tool 100 from the sheath 200, during an operating procedure. The closing mechanism 300 includes an annular edge 350 adjacent to the annular groove 340, which can axially wrap the protuberance 320 to axially interlock the locking screw 500 and the rear socket 600. The closing button 500 is therefore selectively movable between an unlocked position (Fig.5), where the protrusion 320 on the flap 310 of the closing button 500 is aligned and movable along the groove that axially extends 330 of the rear socket 600 to allow axial movement of the closing button 500 in relation to the rear socket 600, and a locked position (Fig. 6), where the protrusion 320 on the separator 310 of the closing button 500 is aligned with and movable along the annular groove 340 such that the protrusion 320 you can contact the annular end 350 to axially interlock the locking screw 500 and the rear socket 600. As best shown in FIG. 6, a collision 360 formed in the rear socket 600 along the annular groove 340 may involve the protrusion 320 to hold the closing button 500 rotationally to the closed position.
    [0018] An introducer set, according to a number of embodiments, can use any tool or product through the sheath device. Exemplary use of the introducer set is described below in connection with an dilator. However, it should be readily appreciated that other surgical instruments can be used with the introducer set, such as stent grafts, endoprostheses, endoscopes, surgical instruments or others. A guidewire is inserted endoluminally into a patient and toward a desired vascular treatment site. The flexible elongated dilator is provided with a hub and closing button to enclose the posterior fitting. The dilator is inserted through the valve and the sheath. The radially annular portion of the hub aligns the dilator in relation to the valve and the sheath. The sheath assembly, with the casing, valve and dilator axially locked through the appropriate lock and leakage engagement, as discussed above, is inserted into the patient's body along the guidewire. More specifically, the dilator is loaded onto the guidewire and sheathed into the patient along the guidewire. After the dilation of the endovascular distribution path is intended, the dilator can be removed, while the sheath remains in place. To remove the dilator, the closure is rotated so that the protrusion in the guide translates along the annular recess into the groove that extends axially until the protrusion is aligned with the groove. The protrusion translates through the groove, as the closure and dilator are usually axially separated from the valve mounting arrangement.
    [0019] As discussed, the closing button rotates freely in relation to the hub and dilator. Thus, the release of the closing button from the posterior fitting does not cause the unwanted rotation of the dilator, while still on the patient and still does not disturb fluid sealing engagement between the dilator and valve arrangement. In addition, axial separation of the closure button from the posterior fitting causes corresponding axial displacement of the vasculature dilator and sheath, as a result of the rib or ribs that extend from the closure button and engage the laying surfaces of the cube. The dilator can be completely removed by continuous axial separation of the closing button from the mounting leak. Thus, the closing mechanism allows the selective closing and closing of the closing button in relation to the posterior fitting, without causing the rotation of the dilator hub and in relation to the sheath and valve, while the tool remains in the patient's vasculature and even more without compromising the sealing of the coupling fluid between the tool and the valve device.
    [0020] Although the valve arrangement has been discussed illustratively as an introduction valve, several modalities cover other applications, such as bariatric access, medical injection port, vascular access port, valve for insertion sites, such as feeding tubes or dialysis access port, etc.
    [0021] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention covers the modifications and variations of this invention as long as they are within the scope of the appended claims and their equivalents.
    权利要求:
    Claims (14)
    [0001]
    1. Introducer set characterized by comprising: a sheath that is generally tubular; a tool that can slide through the sheath; a valve; a closing mechanism operationally coupled to the sheath and the tool to selectively lock the tool and the sheath, the closing mechanism being operable between a closed and unlocked position for axially removable locking the tool and the sheath, without causing the tool to move in relation the hem; an escape fitting coupled to a valve end opposite the sheath; wherein the closing mechanism includes a closing button that can rotate between the locked and unlocked positions without causing the tool to rotate in relation to the sheath; and wherein the closing mechanism includes a closing tab that extends axially from one end of the closing button and engages the drag attachment while in the locked position to axially lock the tool in relation to the sheath; wherein the closing mechanism includes a hub coupled to the tool, the hub having an annular bearing surface slidably engaged with the closing button to allow rotation of the closing button between the locked and unlocked positions; and wherein the closing mechanism includes a locating surface that extends from the annular bearing surface that surrounds the closing button to axially restrict the closing button in relation to the tool.
    [0002]
    2. Introducer assembly according to claim 1, characterized in that the closing button includes at least one radially extending rib that engages the annular support surface for the rotation of the closing button in relation to the tool and engages the surface positioning to axially limit the locking button in relation to the tool.
    [0003]
    3. Introducer assembly according to claim 1, characterized in that the closing mechanism includes an annular groove formed in the rear socket that receives the closing flap along it to accommodate the rotation of the closing button between the locking and unlocking positions .
    [0004]
    4. Introducer assembly according to claim 3, characterized in that the closing mechanism includes a groove that extends axially, and intersects with the annular groove to receive the closing flap as the closing button is positioned axially in relation to the posterior fitting.
    [0005]
    5. Introducer assembly according to claim 4, characterized in that the closing mechanism includes a protrusion which generally extends radially from the closing flap so as to slide slidably into the annular groove during the movement of the closing button between the positions of lock and unlock.
    [0006]
    6. Introducer assembly according to claim 5, characterized in that the closing mechanism includes an annular edge formed on the rear socket adjacent to the annular groove, the annular edge axially engages the protrusion, during the movement of the closing button between the positions of locking and unlocking to restrict the tool axially in relation to the sheath.
    [0007]
    Introducer assembly according to claim 1, characterized in that the valve includes an inner tube comprising a porous substrate, the inner tube engaging in a sealed manner with a tool introduced through the valve.
    [0008]
    Introducer assembly according to claim 1, characterized in that the valve comprises an outer tube, and a pressurized space formed between the inner surface of the outer tube and an outer surface of the inner tube.
    [0009]
    9. Introducer assembly according to claim 8, characterized in that the closing mechanism includes a hub coupled to the tool, the hub has an annular support surface slidably connected to the closing button to allow rotation of the closing button between the positions of locked and unlocked.
    [0010]
    10. Introducer assembly according to claim 9, characterized in that the closing mechanism includes a positioning surface extending from the annular support surface that surrounds the closing button to limit axially to the closing button in relation to the tool .
    [0011]
    11. Introducer assembly according to claim 10, characterized in that the closing button includes at least one radially extending rib that engages the annular support surface for the rotation of the closing button in relation to the tool and engages the surface positioning to axially limit the closing button in relation to the tool.
    [0012]
    12. Introducer assembly according to claim 11, characterized in that the tool includes an expander.
    [0013]
    13. Introducer assembly according to claim 12, characterized in that the tool includes a catheter and an endoprosthesis device disposed on one end of the catheter.
    [0014]
    14. Introducer assembly according to claim 13, characterized in that the stent device is an endoprosthesis.
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US4610242A|1984-04-18|1986-09-09|Codman & Shurtleff, Inc.|Endoscope insertion cannula assembly|
    US5158553A|1990-12-26|1992-10-27|Cardiopulmonics|Rotatably actuated constricting catheter valve|
    US5205831A|1991-04-22|1993-04-27|Burron Medical, Inc.|Compression gasket for y-connector|
    US5489274A|1992-10-09|1996-02-06|Boston Scientific Corporation|Rotatable medical valve closure|
    US5391152A|1993-03-12|1995-02-21|C. R. Bard, Inc.|Catheter interlock assembly|
    JP3383043B2|1993-12-24|2003-03-04|テルモ株式会社|connector|
    DE19724282C1|1997-06-09|1998-10-22|Aesculap Ag & Co Kg|Quick-release coupling for surgical instrument within sheath|
    US6228059B1|1999-06-16|2001-05-08|Denis C. Astarita|Endoscopic instrument locks|
    US8262671B2|2003-03-14|2012-09-11|Oscor Inc.|Vascular introducer having hemostatic valve with integral seal|
    JP2007513707A|2003-12-11|2007-05-31|クック・インコーポレイテッド|Hemostatic valve assembly|
    US20060264979A1|2005-05-20|2006-11-23|Shepard Rudolph C|Novel enhanced vascular surgical device|
    EP2486880A3|2007-04-18|2013-01-16|Access Scientific, Inc.|Access device|
    US9314605B2|2008-06-04|2016-04-19|W. L. Gore & Associates, Inc.|Valve assembly for medical procedures|
    EP2520320B1|2008-07-01|2016-11-02|Endologix, Inc.|Catheter system|
    AU2010249050A1|2009-05-12|2011-12-15|Access Scientific, Inc.|Access device with valve|
    US20110087159A1|2009-10-08|2011-04-14|Parihar Shailendra K|Trocar Assembly|
    US8808248B2|2009-10-15|2014-08-19|Biosense Webster, Inc.|Catheter sheath introducer with rotational lock|US20100057048A1|2008-09-04|2010-03-04|Stephen Eldredge|Apparatus, System, and Method for Treating Atypical Headaches|
    WO2014138024A1|2013-03-05|2014-09-12|Amphenol Corporation|High speed printed circuit board with uniform via inside diameter|
    EP3030170B1|2013-08-05|2021-01-06|Cook Medical Technologies LLC|Medical devices having a releasable tubular member|
    CN103892892B|2014-03-01|2015-12-16|杭州康基医疗器械有限公司|Modified form perforator|
    US9974563B2|2014-05-28|2018-05-22|Cook Medical Technologies Llc|Medical devices having a releasable member and methods of using the same|
    EP3177219B1|2014-08-04|2018-09-26|Cook Medical Technologies LLC|Medical devices having a releasable tubular member|
    US10085750B2|2014-10-22|2018-10-02|Covidien Lp|Adapter with fire rod J-hook lockout|
    US10085744B2|2014-12-08|2018-10-02|Covidien Lp|Loading unit attachment band for surgical stapling instrument|
    US10039549B2|2015-01-07|2018-08-07|Covidien Lp|Loading unit retention clip for surgical stapling instrument|
    US10117656B2|2015-01-07|2018-11-06|Covidien Lp|Loading unit locking collar|
    US10022126B2|2015-01-07|2018-07-17|Covidien Lp|Loading unit locking collar|
    CA2935355A1|2015-07-28|2017-01-28|Covidien Lp|Loading unit locking collar|
    US10881408B2|2015-04-22|2021-01-05|Covidien Lp|Interlock assembly for replaceable loading units|
    US10117655B2|2015-07-22|2018-11-06|Covidien Lp|Loading unit locking band for surgical stapling instrument|
    US9980730B2|2015-09-21|2018-05-29|Covidien Lp|Loading unit locking collar with rotational actuated release|
    CN108472098B|2016-01-08|2021-12-28|直观外科手术操作公司|Sheaths for surgical instruments and related devices and methods|
    US11141162B2|2016-07-08|2021-10-12|Covidien Lp|Loading unit locking collar with linearly actuated release|
    EP3570777A2|2017-01-20|2019-11-27|W. L. Gore & Associates, Inc.|Embolic filter system|
    EP3618737B1|2017-05-03|2022-03-16|Medtronic Vascular Inc.|Tissue-removing catheter|
    EP3624722A4|2017-05-18|2020-11-18|Lightfective Ltd.|Methods and devices for treatment of subcutaneous fat|
    法律状态:
    2017-05-16| B15I| Others concerning applications: loss of priority|
    2017-08-08| B12F| Appeal: other appeals|
    2020-05-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-07-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-11-24| B09A| Decision: intention to grant|
    2021-02-09| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/11/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161560638P| true| 2011-11-16|2011-11-16|
    US61/560,638|2011-11-16|
    US13/677,839|US9561347B2|2011-11-16|2012-11-15|Introducer sheath assembly having a locking dilator|
    US13/677,839|2012-11-15|
    PCT/US2012/065536|WO2013074936A1|2011-11-16|2012-11-16|Introducer sheath assembly having a locking dilator|
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