相关申请的交叉引用Cross References to Related Applications
本申请是2013年9月6日提交的名称为“医疗制品固定系统(MEDICAL ARTICLESECUREMENT SYSTEMS)”的国际申请No.PCT/US2013/058606的部分延续案，该国际申请No.PCT/US2013/058606依据35U.S.C.§119(e)要求2012年9月7日提交的名称为“医疗制品固定系统(MEDICAL ARTICLE SECUREMENT SYSTEMS)”的美国临时申请No.61/698,251以及2013年8月22日提交的名称为“医疗制品固定系统(MEDICAL ARTICLE SECUREMENTSYSTEMS)”的美国临时申请No.61/868,778的优先权，前述申请的每一个在此通过引用以其整体内容并入本申请。This application is a partial continuation of the International Application No.PCT/US2013/058606 filed on September 6, 2013, entitled "MEDICAL ARTICLESECUREMENT SYSTEMS", which is based on 35 U.S.C. §119(e) requires U.S. Provisional Application No. 61/698,251, filed September 7, 2012, entitled "MEDICAL ARTICLE SECUREMENT SYSTEMS" and filed August 22, 2013 Priority to US Provisional Application No. 61/868,778 for "MEDICAL ARTICLE SECUREMENT SYSTEMS," each of which is hereby incorporated by reference into this application in its entirety.
技术领域technical field
本发明整体涉及用于将导管、导管延长套件和/或其他医疗制品固定到患者的技术、系统和装置。The present invention generally relates to techniques, systems and devices for securing catheters, catheter extension sets, and/or other medical articles to patients.
背景技术Background technique
医疗患者经常需要进行流体或药物的重复给药或者流体的重复引流。在医疗行业内，利用医用管向患者提供各种液体或溶液极为常见。例如，通常使用诸如导管等医用管来将流体和药物直接引入到患者体内或从患者体内抽出流体。在许多情况下，导管保持在适当位置达多日。在一些情况下，导管可附接到患者达甚至更长的时间，并且可能为了恰当地起作用而需要最小限度的移动。Medical patients often require repeated administration of fluids or drugs or repeated drainage of fluids. In the medical industry, it is very common to use medical tubing to deliver various fluids or solutions to patients. For example, medical tubing, such as catheters, is often used to introduce fluids and medications directly into or withdraw fluids from a patient. In many cases, the catheter remains in place for many days. In some cases, catheters may be attached to the patient for even longer periods of time and may require minimal movement in order to function properly.
限制导管的移动通常是有利的。移动的导管可能引起患者不适，限制流体或药物的给药或者流体的引流，引发感染或被无意间从患者体内去除。为了使导管或其他医用管在治疗的持续时间内保持被恰当地定位，可通过多种方式将导管或医用管稳定在患者身上。最常见地，医疗提供者可尝试通过使用胶带将导管的远端或连接到导管的医疗装置的一部分(诸如连接器配件)固定到患者来限制导管的移动。医疗提供者通常与导管的远端呈交叉状放置长条的胶带(经常采用十字形图案)以将导管远端固定到患者。这种固定旨在阻止导管与患者之间或导管与另一医疗制品(诸如引流管)之间的连接断开，以及防止导管卡在其他物体(例如床栏杆)上。It is often advantageous to restrict movement of the catheter. A moving catheter may cause patient discomfort, restrict fluid or drug administration or fluid drainage, cause infection, or be inadvertently removed from the patient. In order for the catheter or other medical tubing to remain properly positioned for the duration of the therapy, the catheter or medical tubing can be stabilized on the patient in a number of ways. Most commonly, a medical provider may attempt to restrict movement of the catheter by securing the distal end of the catheter or a portion of the medical device connected to the catheter (such as a connector fitting) to the patient with tape. Medical providers typically place strips of tape (often in a cross-shaped pattern) across the distal end of the catheter to secure the distal end of the catheter to the patient. This securing is intended to prevent disconnection between the catheter and the patient or between the catheter and another medical article, such as a drain, and to prevent the catheter from becoming lodged in other objects, such as a bed rail.
发明内容Contents of the invention
本发明的装置、系统和方法具有若干特征，这些特征中的任一单个特征均不对本发明所期望属性全权负责。在不限制如下文权利要求所表达的本发明的范围的情况下，现在将简要论述其比较突出的特征。在考虑本论述之后，特别是在阅读标题为“具体实施方式”的章节之后，人们将理解本发明的特征如何提供优于其他固定系统的若干优点。The devices, systems and methods of the invention have several features, no single one of which is solely responsible for the desirable attributes of the invention. Without limiting the scope of the invention as expressed in the following claims, its more salient features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description of Preferred Embodiments", one will understand how the features of this invention provide several advantages over other securing systems.
本发明的一个方面是固定系统，该系统包括：具有细长主体的医疗制品，以及具有保持器和锚定垫的稳定装置。保持器可具有近侧、远侧和上侧。保持器可具有设置在保持器内的凹陷部和通道。通道可从凹陷部延伸到保持器的近侧。细长主体的至少一部分可设置在凹陷部内。细长主体的至少一部分可延伸穿过通道并且超出保持器的近侧。保持器可包括至少一个粘合表面。粘合表面可设置在保持器的面朝上的表面的至少一部分上。通道可具有小于凹陷部的侧向宽度的侧向宽度。通道可具有小于凹陷部的侧向宽度的侧向宽度。保持器可包括至少一个邻接部(abutment)，该至少一个邻接部被构造成接触细长主体的面朝近侧的表面，以防止细长主体在至少近侧方向上移动。该至少一个邻接部可设置在凹陷部与通道之间。该邻接部可被构造成接触细长主体的面朝远侧的表面，以防止细长主体在至少远侧方向上移动。One aspect of the invention is a fixation system comprising a medical article having an elongate body, and a stabilization device having a retainer and anchor pads. A retainer can have a proximal side, a distal side and an upper side. The retainer may have a recess and a channel disposed within the retainer. A channel may extend from the recess to a proximal side of the retainer. At least a portion of the elongated body may be disposed within the recess. At least a portion of the elongated body may extend through the channel and beyond the proximal side of the retainer. The retainer may include at least one adhesive surface. An adhesive surface may be provided on at least a portion of the upwardly facing surface of the holder. The channel may have a lateral width smaller than that of the recess. The channel may have a lateral width smaller than that of the recess. The retainer may include at least one abutment configured to contact a proximally-facing surface of the elongated body to prevent movement of the elongated body in at least a proximal direction. The at least one abutment may be arranged between the recess and the channel. The abutment can be configured to contact the distal-facing surface of the elongated body to prevent movement of the elongated body in at least a distal direction.
另一方面是被构造成固定具有细长主体的医疗制品的保持器。该保持器可包括近侧、远侧、底侧和顶侧。在该保持器的顶侧中可设置凹陷部。该凹陷部可被构造成接纳细长主体的第一部分。通道可从该凹陷部延伸穿过该保持器的近侧。该通道可被构造成接纳细长主体的第二部分。锚定垫可固定到该保持器的底侧并且被构造成将锚定垫固定到患者的皮肤。该通道可具有小于凹陷部的侧向宽度的侧向宽度。Another aspect is a holder configured to secure a medical article having an elongated body. The retainer can include a proximal side, a distal side, a bottom side and a top side. A recess may be provided in the top side of the holder. The recess may be configured to receive the first portion of the elongated body. A channel may extend from the recess through the proximal side of the retainer. The channel can be configured to receive the second portion of the elongated body. An anchor pad may be secured to the underside of the retainer and configured to secure the anchor pad to the patient's skin. The channel may have a lateral width that is smaller than that of the recess.
另一方面是固定系统，该系统包括：具有细长主体的医疗制品，以及稳定装置。该装置包括保持器和锚定垫。保持器包括凹陷部和折翼(flap)，其中折翼从打开位置到闭合位置是可移动的。该主体的至少一部分设置在凹陷部中并且在折翼下方，以至少在折翼处于闭合位置中时将该主体固定到保持器。Another aspect is an immobilization system comprising: a medical article having an elongated body, and a stabilization device. The device includes a retainer and anchor pads. The retainer includes a recess and a flap, wherein the flap is movable from an open position to a closed position. At least a portion of the body is disposed in the recess and below the flap to secure the body to the retainer at least when the flap is in the closed position.
另一方面是固定系统，该系统包括：具有细长主体的医疗制品，以及稳定装置。该装置包括保持器和锚定垫。保持器包括凹陷部和敷料，其中敷料从打开位置到闭合位置是可移动的。该主体的至少一部分设置在凹陷部中并且在敷料下方，以至少在敷料处于闭合位置中时将该主体固定到保持器。Another aspect is an immobilization system comprising: a medical article having an elongated body, and a stabilization device. The device includes a retainer and anchor pads. The retainer includes a recess and a dressing, wherein the dressing is movable from an open position to a closed position. At least a portion of the body is disposed in the recess and beneath the dressing to secure the body to the retainer at least when the dressing is in the closed position.
另一方面是固定系统，该系统包括：具有细长主体的医疗制品，以及稳定装置。该装置包括保持器和锚定垫。保持器包括用于接纳医疗制品的至少一部分的凹陷部。锚定垫的第一部分从打开位置到闭合位置是可移动的，当第一部分处于闭合位置中时，第一部分附着到锚定垫的第二部分。Another aspect is an immobilization system comprising: a medical article having an elongated body, and a stabilization device. The device includes a retainer and anchor pads. The holder includes a recess for receiving at least a portion of the medical article. A first portion of the anchor pad is movable from an open position to a closed position, the first portion being attached to a second portion of the anchor pad when the first portion is in the closed position.
另一方面是固定系统，该系统包括：具有细长主体的医疗制品，以及稳定装置。该装置包括保持器和锚定垫。保持器由锚定垫支承并且被构造成接纳医疗制品。该系统还包括连接到锚定垫并且被构造成覆盖插入部位的敷料。该敷料具有下表面以及槽，其中，下表面至少部分地被粘合剂覆盖以用于接触患者的皮肤，槽被构造成允许医疗制品在敷料施加到患者的皮肤期间在锚定垫的至少一部分与敷料之间通过。Another aspect is an immobilization system comprising: a medical article having an elongated body, and a stabilization device. The device includes a retainer and anchor pads. The retainer is supported by the anchor pads and is configured to receive a medical article. The system also includes a dressing connected to the anchor pad and configured to cover the insertion site. The dressing has a lower surface, wherein the lower surface is at least partially covered by adhesive for contacting the patient's skin, and a groove configured to allow the medical article to anchor at least a portion of the pad during application of the dressing to the patient's skin. Pass between with dressing.
另一方面是固定系统，该系统包括：具有细长主体的医疗制品，以及稳定装置。稳定装置可具有保持器和锚定垫。保持器可具有近侧、远侧和上侧。保持器可包括至少一个粘合表面。在一些方面，保持器的上侧包括至少一个粘合表面。保持器可具有形成于保持器内的凹陷部和通道。通道可从凹陷部延伸到保持器的近侧。细长主体的至少一部分可设置在凹陷部和通道内。细长主体的至少一部分可接触保持器的至少一个粘合表面。Another aspect is an immobilization system comprising: a medical article having an elongated body, and a stabilization device. A stabilization device may have a retainer and anchor pads. A retainer can have a proximal side, a distal side and an upper side. The retainer may include at least one adhesive surface. In some aspects, the upper side of the retainer includes at least one adhesive surface. The retainer may have a recess and a channel formed in the retainer. A channel may extend from the recess to a proximal side of the retainer. At least a portion of the elongated body may be disposed within the recess and channel. At least a portion of the elongated body may contact at least one adhesive surface of the retainer.
另一方面是还具有敷料的固定系统，该敷料具有垫层和透明膜层。该垫可具有第一窗口，使得在敷料放置在稳定装置上方时，透过第一窗口可看到医疗制品的主体。该垫可包括第二窗口，使得在敷料放置在稳定装置上方时，透过第二窗口可看到医疗制品的插入部位。在一些方面，凹陷部包括至少一个邻接部，该至少一个邻接部被构造成接触细长主体的面朝近侧的表面，以防止细长主体在至少近侧方向上移动。Another aspect is an immobilization system that also has a dressing with a backing layer and a transparent film layer. The pad may have a first window such that the body of the medical article is visible through the first window when the dressing is placed over the stabilizing device. The pad may include a second window such that the insertion site of the medical article is visible through the second window when the dressing is placed over the stabilizing device. In some aspects, the recess includes at least one abutment configured to contact the proximally-facing surface of the elongated body to prevent movement of the elongated body in at least a proximal direction.
另一方面是被构造以将具有细长主体的医疗制品固定到患者的固定装置，该装置可包括锚定垫和由锚定垫支承的保持器。保持器可包括被构造成接纳细长主体的至少一部分的凹陷部。敷料可结合到锚定垫。敷料可被构造成从打开位置到闭合位置是可移动的，以将细长主体固定到保持器并且至少在敷料处于闭合位置中时覆盖插入部位。Another aspect is a fixation device configured to secure a medical article having an elongated body to a patient, the device may include an anchor pad and a retainer supported by the anchor pad. The retainer can include a recess configured to receive at least a portion of the elongated body. The dressing can be bonded to the anchor pad. The dressing may be configured to be movable from an open position to a closed position to secure the elongated body to the retainer and cover the insertion site at least when the dressing is in the closed position.
另一方面是被构造成将具有细长主体的医疗制品固定到患者的固定装置，该装置可包括锚定垫和由锚定垫支承的保持器。保持器可包括被构造成接纳细长主体的至少一部分的凹陷部。折翼可结合到锚定垫。折翼可被构造成从打开位置到闭合位置是可移动的。折翼可包括至少一个粘合表面，该至少一个粘合表面被构造成在折翼处于闭合位置中时将折翼固定到至少细长主体。Another aspect is a fixation device configured to secure a medical article having an elongate body to a patient, the device may include an anchor pad and a retainer supported by the anchor pad. The retainer can include a recess configured to receive at least a portion of the elongated body. Flaps may be coupled to anchor pads. The flaps may be configured to be movable from an open position to a closed position. The flap may include at least one adhesive surface configured to secure the flap to at least the elongated body when the flap is in the closed position.
另一方面是被构造成将具有细长主体的医疗制品固定到患者的固定装置，该装置可包括具有第一部分和第二部分的锚定垫。锚定垫的第一部分可被构造成从打开位置到闭合位置是可移动的并且可被构造成在锚定垫的第一部分处于闭合位置中时附着到锚定垫的第二部分。保持器可由锚定垫的第二部分支承。保持器可包括被构造成接纳医疗制品的至少一部分的凹陷部。Another aspect is a fixation device configured to secure a medical article having an elongated body to a patient, the device may include an anchor pad having a first portion and a second portion. The first portion of the anchor pad may be configured to be movable from the open position to the closed position and may be configured to attach to the second portion of the anchor pad when the first portion of the anchor pad is in the closed position. The retainer can be supported by the second portion of the anchor pad. The holder can include a recess configured to receive at least a portion of the medical article.
另一方面是被构造成将具有细长主体的医疗制品固定到患者的固定装置，该装置可包括锚定垫和由锚定垫支承的保持器。保持器可被构造以接纳医疗制品的至少一部分。敷料可连接到锚定垫。敷料可被构造成覆盖插入部位。敷料可具有下表面，该下表面至少部分地被粘合剂覆盖以用于将敷料附着到患者的皮肤。敷料可具有槽，该槽被构造成允许医疗制品在敷料与锚定垫施加到患者的皮肤期间在锚定垫的至少一部分与敷料之间通过。Another aspect is a fixation device configured to secure a medical article having an elongate body to a patient, the device may include an anchor pad and a retainer supported by the anchor pad. The holder can be configured to receive at least a portion of the medical article. The dressing can be attached to the anchor pad. The dressing can be configured to cover the insertion site. The dressing may have a lower surface at least partially covered by an adhesive for attaching the dressing to the patient's skin. The dressing may have a groove configured to allow passage of a medical article between at least a portion of the anchor pad and the dressing during application of the dressing and anchor pad to the patient's skin.
另一方面是被构造成将具有细长主体的医疗制品固定到患者的固定装置，该装置可包括锚定垫和由锚定垫支承的保持器。保持器可被构造以接纳医疗制品的至少一部分。支承构件可被结合到锚定垫，该支承构件被构造以支承在保持器中向凹陷部远侧延伸的医疗制品的一部分。支承构件可包括用于可拆卸地将支承构件锁定到医疗制品的通路(passage)。支承构件可以成型为棱柱(prism)形状。支承构件可沿折叠线(fold line)结合到保持器。折叠线可被穿孔以便于支承构件与保持器的分离。Another aspect is a fixation device configured to secure a medical article having an elongate body to a patient, the device may include an anchor pad and a retainer supported by the anchor pad. The holder can be configured to receive at least a portion of the medical article. A support member may be bonded to the anchor pad, the support member being configured to support a portion of the medical article extending distally of the recess in the retainer. The support member may include passages for releasably locking the support member to the medical article. The support member may be shaped in a prism shape. The support member may be coupled to the holder along a fold line. The fold line may be perforated to facilitate separation of the support member from the holder.
附图说明Description of drawings
下文参考旨在示出而非限制本发明的特定实施方式的附图来描述本文所公开的发明的这些以及其他特征、方面和优点。另外，在各图之中，已使用相同参考编号来指明所示实施方式的相同组件。以下为对这些附图中的每个的简要描述。These and other features, aspects and advantages of the inventions disclosed herein are described below with reference to the accompanying drawings which are intended to illustrate, but not to limit, specific embodiments of the invention. Additionally, throughout the figures, the same reference numerals have been used to designate the same components of the illustrated embodiments. A brief description of each of these figures follows.
图1-2是根据本发明的一个实施方式的固定装置的透视图。1-2 are perspective views of a securing device according to one embodiment of the present invention.
图3-4是图1的固定装置的透视图，其中衬件被移除。3-4 are perspective views of the securing device of Fig. 1 with the liner removed.
图5是图2的固定装置的分解图。FIG. 5 is an exploded view of the fixing device of FIG. 2 .
图6是图1的固定装置的平面图，其中衬件被移除。Figure 6 is a plan view of the fixture of Figure 1 with the liner removed.
图7是图3的固定装置的透视图，其中衬件被移除并且医疗制品被放置在保持器中。7 is a perspective view of the fixation device of FIG. 3 with the liner removed and the medical article placed in the holder.
图8-9是可与图1的固定装置组合使用的敷料的透视图。8-9 are perspective views of dressings that may be used in combination with the fixation device of FIG. 1 .
图10是图8的敷料的分解图。FIG. 10 is an exploded view of the dressing of FIG. 8 .
图11是图8的敷料的平面图。FIG. 11 is a plan view of the dressing of FIG. 8 .
图12A和图13-14是使用图1的固定装置的方法的透视图。如图所示，该方法可通过移除设置在保持器上方的衬件而开始。12A and 13-14 are perspective views of a method of using the fixation device of FIG. 1 . As shown, the method may begin by removing a liner disposed over the retainer.
图12B-D是用于设置在保持器或锚定垫的表面上方的衬件的透视图。12B-D are perspective views of a liner for placement over a surface of a retainer or anchor pad.
图15-17是使用图1的固定装置的方法的透视图。如图所示，该方法可通过移除设置在保持器底部表面的一部分的上方的第一衬件而继续。保持器可放置在患者身上，并且医疗制品可放置在保持器中。15-17 are perspective views of a method of using the fixation device of Fig. 1 . As shown, the method may continue by removing the first liner disposed over a portion of the bottom surface of the retainer. A retainer can be placed on a patient, and a medical article can be placed in the retainer.
图18-19是使用图1的固定装置的方法的透视图。如图所示，该方法可通过移除设置在保持器底部表面的一部分的上方的第二衬件而继续。可在将医疗制品被放置在保持器内之前或之后将保持器固定到患者。18-19 are perspective views of a method of using the fixation device of Fig. 1 . As shown, the method may continue by removing a second liner disposed over a portion of the bottom surface of the retainer. The retainer can be secured to the patient before or after the medical article is placed within the retainer.
图20-22是使用图8的敷料的方法的透视图。如图所示，该方法可通过从敷料的患者侧表面的一部分移除第一衬件而开始。20-22 are perspective views of a method of using the dressing of FIG. 8 . As shown, the method may begin by removing the first liner from a portion of the patient-side surface of the dressing.
图23-24是使用图8的敷料的方法的透视图。如图所示，该方法可通过从敷料的患者侧表面的一部分移除第二衬件而开始。23-24 are perspective views of a method of using the dressing of FIG. 8 . As shown, the method may begin by removing the second liner from a portion of the patient-side surface of the dressing.
图25-26是使用图8的敷料的方法的透视图。如图所示，该方法可通过将敷料放置在插入部位和医疗制品的至少一部分的上方而继续。25-26 are perspective views of a method of using the dressing of FIG. 8 . As shown, the method may continue by placing a dressing over the insertion site and at least a portion of the medical article.
图27-28是根据本发明的另一实施方式的固定装置的透视图。27-28 are perspective views of a securing device according to another embodiment of the present invention.
图29是图1的固定装置的另一透视图，并且显示了在保持器的折翼横跨医疗制品折叠之前放置在保持器中的医疗制品。29 is another perspective view of the securement device of FIG. 1 and shows the medical article placed in the holder before the flaps of the holder are folded across the medical article.
图30是图27的固定装置的分解图。FIG. 30 is an exploded view of the securing device of FIG. 27 .
图31是图27的固定装置的平面图。FIG. 31 is a plan view of the securing device of FIG. 27. FIG.
图32是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过移除设置在保持器上方的衬件而开始。32 is a top view of a method of using the immobilization device of FIG. 27. FIG. As shown, the method may begin by removing a liner disposed over the retainer.
图33是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过将医疗制品放置在保持器中而继续。33 is a top view of a method of using the immobilization device of FIG. 27. FIG. As shown, the method may continue by placing the medical article in the holder.
图34-36是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过移除覆盖锚定垫的下表面的衬件而继续。34-36 are top views of a method of using the immobilization device of Fig. 27. Figs. As shown, the method may continue by removing the liner covering the lower surface of the anchor pad.
图37-38是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过移除折翼的粘合表面上的衬件而继续。37-38 are top views of a method of using the immobilization device of FIG. 27 . As shown, the method may continue by removing the liner on the adhesive surface of the flap.
图39-40是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过横跨医疗制品的上表面折叠折翼而继续。39-40 are top views of a method of using the immobilization device of Fig. 27. Figs. As shown, the method may continue by folding the flap across the upper surface of the medical article.
图41是图27的固定装置的顶视图，其中折翼处于闭合位置中。Figure 41 is a top view of the securing device of Figure 27 with the flaps in the closed position.
图42-43是使用图27的固定装置的方法的顶视图。如图所示，该方法可通过将敷料放置在插入部位和医疗制品的至少一部分的上方而继续。42-43 are top views of a method of using the immobilization device of Fig. 27. Figs. As shown, the method may continue by placing a dressing over the insertion site and at least a portion of the medical article.
图44-45是显示根据本发明的另一实施方式的固定系统的透视图。44-45 are perspective views showing a fixation system according to another embodiment of the present invention.
图46是图44的固定装置的另一透视图，并且显示了放置在保持器中的医疗制品。Fig. 46 is another perspective view of the securement device of Fig. 44, and showing the medical article placed in the holder.
图47是图44的固定装置的分解图。FIG. 47 is an exploded view of the securing device of FIG. 44 .
图48是使用图44的固定装置的方法的透视图。如图所示，该方法可通过移除设置在保持器上方的衬件而开始。48 is a perspective view of a method of using the immobilization device of FIG. 44. FIG. As shown, the method may begin by removing a liner disposed over the retainer.
图49是使用图44的固定装置的方法的透视图。如图所示，该方法可通过移除锚定垫的下表面上的衬件而继续。49 is a perspective view of a method of using the immobilization device of FIG. 44 . As shown, the method may continue by removing the liner on the lower surface of the anchor pad.
图50是使用图44的固定装置的方法的顶视图。如图所示，该方法可通过将医疗制品放置在保持器内而继续。50 is a top view of a method of using the immobilization device of FIG. 44. FIG. As shown, the method may continue by placing the medical article within the holder.
图51-53是使用图44的固定装置的方法的顶视图。如图所示，该方法可通过从敷料移除衬件并且接着将敷料折叠到医疗制品上方而继续。医疗制品穿过敷料中的槽。51-53 are top views of a method of using the immobilization device of Fig. 44. Figs. As shown, the method may continue by removing the liner from the dressing and then folding the dressing over the medical article. The medical article passes through the slots in the dressing.
图54-55是根据本发明的另一实施方式的固定装置的透视图。54-55 are perspective views of a fixation device according to another embodiment of the invention.
图56是图54的固定装置的另一透视图，并且显示了在锚定垫或折翼的一部分折叠到医疗制品上方之前放置在保持器中的医疗制品。56 is another perspective view of the securement device of FIG. 54 and shows the medical article placed in the holder prior to folding a portion of the anchor pad or flap over the medical article.
图57是图54的固定装置的分解图。FIG. 57 is an exploded view of the securing device of FIG. 54. FIG.
图58是图54的固定装置的顶视图，该装置包括装置下表面上的剥离衬件。Figure 58 is a top view of the fixation device of Figure 54 including a release liner on the lower surface of the device.
图59是使用图54的固定装置的方法的顶视图。如图所示，该方法可通过移除覆盖锚定垫的下表面的衬件而开始。59 is a top view of a method of using the immobilization device of FIG. 54. FIG. As shown, the method may begin by removing the liner covering the lower surface of the anchor pad.
图60是使用图54的固定装置的方法的顶视图。如图所示，该方法可通过使固定装置在患者的皮肤与医疗制品之间滑动同时引导医疗制品穿过固定装置中的槽而继续。60 is a top view of a method of using the immobilization device of FIG. 54 . As shown, the method may continue by sliding the fixation device between the patient's skin and the medical article while guiding the medical article through the slot in the fixation device.
图61是使用图54的固定装置的方法的顶视图。如图所示，该方法可通过移除锚定垫下表面上的第二衬件而继续。61 is a top view of a method of using the immobilization device of FIG. 54. FIG. As shown, the method may continue by removing the second liner on the lower surface of the anchor pad.
图62是固定到患者的图54的固定装置的透视图。62 is a perspective view of the fixation device of FIG. 54 secured to a patient.
图63-65是使用图54的固定装置的方法的顶视图。如图所示，该方法可通过从折翼移除衬件而继续。63-65 are top views of a method of using the immobilization device of Fig. 54. Figs. As shown, the method may continue by removing the liner from the flap.
图66-67是使用图54的固定装置的方法的顶视图。如图所示，该方法可通过将折翼折叠到医疗制品上方而继续。66-67 are top views of a method of using the immobilization device of Fig. 54. Figs. As shown, the method may continue by folding the flap over the medical article.
图68是图54的固定装置的后透视图，该图显示了固定于固定装置中的医疗制品。Fig. 68 is a rear perspective view of the securement device of Fig. 54, showing the medical article secured in the securement device.
图69-70是根据本发明的另一实施方式的固定装置的透视图。69-70 are perspective views of a fixation device according to another embodiment of the invention.
图71是图69的固定装置的另一透视图，并且显示了放置在保持器上的医疗制品，其中一体的敷料覆盖插入部位。Fig. 71 is another perspective view of the fixation device of Fig. 69, and showing the medical article placed on the holder with an integral dressing covering the insertion site.
图72是图69的固定装置的分解图。FIG. 72 is an exploded view of the securing device of FIG. 69 .
图73是图69的固定装置的顶视图，该装置包括固定装置底部表面上的多个衬件。73 is a top view of the fixture of FIG. 69 including a plurality of liners on the bottom surface of the fixture.
图74是使用图69的固定装置的方法的顶视图。如图所示，该方法可通过移除设置在保持器上方的衬件并且使锚定垫沿着槽折叠而开始。74 is a top view of a method of using the immobilization device of FIG. 69 . As shown, the method may begin by removing the liner disposed over the retainer and folding the anchor pad along the slot.
图75是使用图69的固定装置的方法的顶视图。如图所示，该方法可通过移除衬件并且使固定装置在患者皮肤与医疗制品之间滑动同时引导医疗制品穿过槽而继续。75 is a top view of a method of using the immobilization device of FIG. 69 . As shown, the method may continue by removing the liner and sliding the fixation device between the patient's skin and the medical article while guiding the medical article through the slot.
图76是使用图69的固定装置的方法的顶视图。如图所示，该方法可通过从敷料和锚定垫的底部表面移除衬件并且将敷料和锚定垫附接到患者而继续。76 is a top view of a method of using the immobilization device of FIG. 69 . As shown, the method may continue by removing the liner from the bottom surface of the dressing and anchor pad and attaching the dressing and anchor pad to the patient.
图77-78是使用图69的固定装置的方法的顶视图。如图所示，该方法可通过从敷料的底部表面移除额外衬件而继续。77-78 are top views of a method of using the immobilization device of Fig. 69. Figs. As shown, the method can continue by removing the additional liner from the bottom surface of the dressing.
图79是图69的固定装置的顶视图，其中敷料固定在医疗制品上方并且固定装置附接到患者。Fig. 79 is a top view of the immobilization device of Fig. 69 with a dressing secured over the medical article and the immobilization device attached to the patient.
图80和83是支承构件的透视图。80 and 83 are perspective views of a support member.
图81-82是具有图80的支承构件的固定装置的透视图。81-82 are perspective views of a fixation device having the support member of FIG. 80 .
图84-85是具有图83的支承构件的固定装置的透视图。84-85 are perspective views of a fixation device having the support member of FIG. 83 .
具体实施方式Detailed ways
以下描述和例子示出在与示例性导管一起使用的环境中所公开的本发明固定装置的优选实施方式。更具体地讲，这些实施方式涉及使医疗制品稳定在患者身上的适当位置的稳定装置和相关技术。在所示固定装置的实施方式中，导管用作外周静脉内(“I.V.”)管线的一部分。The following description and examples illustrate preferred embodiments of the disclosed fixation device of the present invention in the context of use with an exemplary catheter. More specifically, these embodiments relate to stabilization devices and related technologies that stabilize medical articles in place on a patient. In the illustrated embodiment of the fixation device, the catheter serves as part of a peripheral intravenous ("I.V.") line.
以下描述和附图描述并且显示优选实施方式，用以展示固定装置、和/或固定系统可采取的若干可能配置，以包括本发明的各种公开的方面和特征。所示实施方式被显示为与具有旋转螺母的导管一起使用。在此环境中的固定装置的举例说明并不旨在将所公开的方面和特征限于所指定的实施方式或限于仅与所示导管一起使用。例如，所公开的实施方式可与连接器配件一起使用。连接器配件可包括旋转螺母或其他向外延伸的特征部。本领域技术人员将认识到，所公开的方面和特征并不限于固定系统的任何具体实施方式，并且包括本文所述的具有创造性的方面和特征中的一者或多者的固定系统可被设计为与多种医疗制品一起使用。The following description and drawings describe and illustrate preferred embodiments to illustrate several possible configurations that a fixation device, and/or a fixation system can take, to incorporate various disclosed aspects and features of the present invention. The illustrated embodiment is shown for use with a catheter having a swivel nut. The illustration of a fixation device in this context is not intended to limit the disclosed aspects and features to the specified implementation or to use only with the illustrated catheter. For example, the disclosed embodiments may be used with connector fittings. The connector fitting may include a swivel nut or other outwardly extending feature. Those skilled in the art will appreciate that the disclosed aspects and features are not limited to any particular implementation of the fixation system, and that a fixation system including one or more of the inventive aspects and features described herein may be designed For use with various medical products.
考虑到本发明的内容，本领域技术人员将理解，所述固定装置可与其他类型的医疗制品一起使用，这些医疗制品包括但不限于各种设计的导管和导管套节(catheter hub)(具有或不具有连接器或延长套件)，诸如中心静脉导管、外周插入式中心导管、血液透析导管、弗利(Foley)导管，以及其他设计的导管套节和导管转接头。其他医疗制品可包括外科引流管、饲管、胸管、鼻胃管、直肠引流管、脑室外引流管、胸管；任何其他种类的流体供应管路或医用管路、连接器配件和观测镜(scopes)，以及连接到外部的或植入的电子装置或传感器的电线或电缆。所述医疗制品可为单个医疗制品或若干医疗制品的组合。Those skilled in the art, in view of the present disclosure, will understand that the fixation device may be used with other types of medical articles including, but not limited to, catheters and catheter hubs (with or without connectors or extension sets), such as central venous catheters, peripherally inserted central catheters, hemodialysis catheters, Foley catheters, and other designs of catheter hubs and catheter adapters. Other medical articles may include surgical drains, feeding tubes, chest tubes, nasogastric tubes, rectal drains, external ventricular drains, chest tubes; any other kind of fluid supply line or medical tubing, connector fittings and scopes (scopes), and wires or cables connected to external or implanted electronic devices or sensors. The medical article may be a single medical article or a combination of several medical articles.
本文所述的固定装置尤其适于阻止导管的至少横向移动。固定装置将医疗制品保持抵靠患者并且保护插入部位附近的区域。固定装置在不有意损害(即，实质上阻塞)穿过医疗制品的管腔的流体流或损害医疗制品的插入的情况下实现此目标。在一些实施方式中，用以实现此目标的保持机构包括具有凹陷部、折翼、绑带、锚定垫、和/或敷料的保持器。例如，凹陷部、折翼、绑带、锚定垫和/或敷料可涂覆有粘合剂。折翼或绑带可与固定装置成一整体，并且折叠在放置在保持器中的医疗制品的上方并且固定该医疗制品。在其它实施方式中，固定装置可包括一体化敷料或锚定垫的一部分，并且一体化敷料或锚定垫的一部分被构造成覆盖插入部位。一体化敷料/锚定垫可折叠到锚定垫/保持器的另一部分的上方，使得医疗制品设置在两者间。The fixation device described herein is particularly suitable for preventing at least lateral movement of the catheter. The securing device holds the medical article against the patient and protects the area near the insertion site. The fixation device accomplishes this without intentionally impairing (ie, substantially obstructing) fluid flow through the lumen of the medical article or compromising insertion of the medical article. In some embodiments, retention mechanisms to accomplish this include a retainer having a recess, flaps, straps, anchor pads, and/or a dressing. For example, recesses, flaps, straps, anchor pads, and/or dressings may be coated with adhesive. The flaps or straps may be integral with the securing device and fold over and secure the medical article placed in the holder. In other embodiments, the fixation device may comprise a portion of an integral dressing or anchor pad, and the portion of the integral dressing or anchor pad is configured to cover the insertion site. The integrated dressing/anchor pad can be folded over another portion of the anchor pad/retainer such that the medical article is disposed therebetween.
一般来讲，固定装置可附接到患者，且医疗制品可至少部分地放置在固定装置内。固定装置可包括凹陷部。该凹陷部可由一个或多个向上延伸壁形成。向上延伸壁可被成形以包括一个或多个邻接表面。邻接表面可阻止、和/或防止放置在固定装置中的医疗制品在至少一个方向上的移动。这些向上延伸壁的一个或多个表面上可包括粘合剂。在一些实施方式中，形成凹陷部的向上延伸壁的顶部表面的至少一部分涂覆有粘合剂。敷料可被构造成覆盖插入部位、固定装置、和医疗制品的至少一部分。医疗制品可设置在固定装置与敷料之间。在一些实施方式中，敷料可与固定装置成一整体。Generally, an immobilization device can be attached to a patient, and a medical article can be placed at least partially within the immobilization device. The securing means may comprise a recess. The recess may be formed by one or more upwardly extending walls. The upwardly extending wall may be shaped to include one or more abutment surfaces. The abutment surface can resist, and/or prevent, movement in at least one direction of a medical article placed in the fixture. These upwardly extending walls may include adhesive on one or more surfaces. In some embodiments, at least a portion of the top surface of the upwardly extending wall forming the recess is coated with an adhesive. The dressing can be configured to cover at least a portion of the insertion site, the fixation device, and the medical article. A medical article may be disposed between the immobilization device and the dressing. In some embodiments, the dressing can be integral with the immobilization device.
为协助描述固定系统的这些组件，使用以下坐标术语(参见例如图7、图25、图27、图46、图56和图71)。“纵向轴线”大致平行于由固定系统保持的导管套节或其他医疗制品的一部分，以及平行于医疗制品延伸穿过的保持器的凹陷部的轴线。“侧向轴线”与纵向轴线垂直。“横向轴线”沿与纵向轴线和侧向轴线两者垂直的方向延伸。To assist in describing these components of the fixation system, the following coordinate terminology is used (see eg, Figures 7, 25, 27, 46, 56, and 71). The "longitudinal axis" is generally parallel to the axis of the portion of the catheter hub or other medical article held by the fixation system and parallel to the recess of the holder through which the medical article extends. "Lateral axis" is perpendicular to the longitudinal axis. A "transverse axis" extends in a direction perpendicular to both the longitudinal axis and the lateral axis.
另外，如本文所用，“纵向方向”是指基本上平行于纵向轴线的方向；“侧向方向”是指基本上平行于侧向轴线的方向；并且“横向方向”是指基本上平行于横向轴线的方向。如本文所用的术语“轴向”是指通道、凹陷部或套节的轴线，因此与如本文所用的术语“纵向”基本上同义。另外，用于描述本发明固定系统的术语“近侧”和“远侧”的使用与示例性应用(即，使用应用的示例性例子)的描述一致。因此，近侧和远侧是以患者身体的中心为参照而使用的。Additionally, as used herein, "longitudinal direction" refers to a direction substantially parallel to the longitudinal axis; "lateral direction" refers to a direction substantially parallel to the lateral axis; and "transverse direction" refers to a direction substantially parallel to the transverse direction. The direction of the axis. The term "axial" as used herein refers to the axis of the channel, recess or hub and is therefore substantially synonymous with the term "longitudinal" as used herein. Additionally, the use of the terms "proximal" and "distal" to describe the fixation system of the present invention is consistent with the description of the exemplary application (ie, an exemplary example of an application of use). Accordingly, proximal and distal are used with reference to the center of the patient's body.
也用于描述本发明固定系统的术语“上部”、“下部”、“顶部”、“底部”、“下侧”、“上侧”等是以实施方式的所示取向为参照而使用的。例如，术语“上侧”用于描述保持器位于穿过保持器中的凹陷部的轴线的侧向轴线上面的部分。术语“下侧”用于描述保持器位于穿过保持器中的凹陷部的轴线的侧向轴线下面的部分。现在描述固定系统的所述实施方式共有特征中的一些的简要介绍。The terms "upper", "lower", "top", "bottom", "lower side", "upper side", etc., which are also used to describe the fastening system of the present invention, are used with reference to the illustrated orientation of the embodiment. For example, the term "upper side" is used to describe the portion of the retainer that is located above a lateral axis passing through the axis of the recess in the retainer. The term "lower side" is used to describe the part of the retainer which is located below the lateral axis passing through the axis of the recess in the retainer. A brief introduction to some of the common features of the described embodiments of the fixation system is now described.
现在将参考为举例说明而选择的具体形式或实施方式来描述各个方面。应当理解的是，本文所公开的固定系统的精神和范围并不限于所选择的形式。此外，应注意的是，本文中所提供的附图未按任何特定比例或尺度绘制，并且可对所示实施方式做出许多变型。现在描述固定系统的所述实施方式共有特征中的一些的简要介绍。Various aspects will now be described with reference to specific forms or implementations chosen for illustration. It should be understood that the spirit and scope of the securement systems disclosed herein are not limited to the form chosen. Furthermore, it should be noted that the drawings provided herein are not drawn to any particular scale or scale and that many variations may be made to the illustrated embodiments. A brief introduction to some of the common features of the described embodiments of the fixation system is now described.
优选实施方式有利地提供用于将医疗制品固定到患者的医用管路固定系统。医疗制品可具有细长主体。细长主体与保持器协作，以阻止医疗制品在放置在保持器内时在纵向、侧向和横向方向上的移动。保持器可包括凹陷部。凹陷部可被设定大小并被成形以用于接纳医疗制品的一部分，例如，旋转螺母。凹陷部可提供一个或多个可限制在纵向、和/或侧向方向上的移动的邻接表面。在一些实施方式中，凹陷部的底部表面包括粘合剂。粘合剂可限制放置在保持器的凹陷部内的医疗制品的纵向、侧向和横向移动。保持器可由一个或多个锚定垫支承。这些锚定垫可包括粘合剂，以将锚定垫附接到患者的皮肤。连接到锚定垫和/或保持器的折翼/绑带可折叠到保持器上方，进一步固定放置在保持器中的医疗制品。Preferred embodiments advantageously provide a medical tubing securement system for securing a medical article to a patient. The medical article may have an elongated body. The elongated body cooperates with the retainer to resist movement of the medical article in longitudinal, lateral and transverse directions when placed within the retainer. The retainer may include a recess. The recess may be sized and shaped to receive a portion of the medical article, eg, a spin nut. The recess may provide one or more abutment surfaces that may restrict movement in longitudinal, and/or lateral directions. In some embodiments, the bottom surface of the recess includes an adhesive. The adhesive can limit longitudinal, lateral and lateral movement of a medical article placed within the recess of the holder. The retainer may be supported by one or more anchor pads. These anchor pads may include adhesive to attach the anchor pads to the patient's skin. Flaps/straps attached to the anchor pads and/or the retainer can be folded over the retainer to further secure the medical article placed in the retainer.
医疗制品可包括插管。插管可插入到患者体内。这种插入部位还可由敷料覆盖。敷料还可限制医疗制品的移动。敷料另外可保护插入部位避免沾到水分和/或受到感染。在一些实施方式中，敷料被一体化或结合到保持器和/或锚定垫。在一些实施方式中，本文所公开的固定系统可在已将医用管路(例如，外周I.V.管路)引入到患者之后附接到患者。Medical articles may include cannulas. A cannula may be inserted into the patient. Such an insertion site may also be covered by a dressing. Dressings can also restrict movement of medical articles. The dressing additionally protects the insertion site from moisture and/or infection. In some embodiments, the dressing is integrated or bonded to the retainer and/or anchor pad. In some embodiments, the fixation systems disclosed herein can be attached to a patient after a medical line (eg, a peripheral I.V. line) has been introduced into the patient.
为便于对实施方式的完整理解，具体实施方式的其余部分参考附图来描述固定系统，其中在以下描述中，实施方式当中的相同元件用同样的编号来提及。To facilitate a complete understanding of the embodiments, the rest of the detailed description describes the fixation system with reference to the accompanying drawings, wherein in the following description, the same elements among the embodiments are referred to by the same numerals.
现在参考图1-2，固定装置100的实施方式包括锚定垫104和保持器101。锚定垫104可具有下表面106和上层105，其中，下表面106可附着到患者的皮肤。锚定垫104的上层105被构造成支承至少保持器101。以组合方式，下表面106、上层105和可能的一个或多个中间层可构成层合结构。包含具有粘合层的泡沫或织造材料的合适的层合材料可商购获得。锚定垫104可被构造为柔性结构，该柔性结构被构造以贴合患者的皮肤的表面。在一些实施方式中，锚定垫104的下表面106的至少一部分包括粘合剂。Referring now to FIGS. 1-2 , an embodiment of a fixation device 100 includes an anchor pad 104 and a retainer 101 . The anchor pad 104 can have a lower surface 106 and an upper layer 105, wherein the lower surface 106 can be attached to the patient's skin. The upper layer 105 of the anchor pad 104 is configured to support at least the retainer 101 . In combination, the lower surface 106, the upper layer 105 and possibly one or more intermediate layers may constitute a laminated structure. Suitable laminates comprising foam or woven materials with adhesive layers are commercially available. The anchor pad 104 may be configured as a flexible structure configured to conform to the surface of the patient's skin. In some embodiments, at least a portion of the lower surface 106 of the anchor pad 104 includes an adhesive.
锚定垫104的上层105可包括泡沫(例如，闭孔聚乙烯泡沫)层或织造材料(例如，经编针织物)层或非织造材料。泡沫层或织造材料层的表面构成锚定垫104的上层。在替代方案中，上层105可包括上部纸层或其他非织造布层，并且内部泡沫层可放置在上层与下部粘合表面之间。在一些实施方式中，锚定垫包括抗微生物添加剂。锚定垫和保持器可保护患者的皮肤免受由医疗装置摩擦皮肤而引起的刺激。The upper layer 105 of the anchor pad 104 may include a layer of foam (eg, closed-cell polyethylene foam) or a layer of woven material (eg, warp-knit) or a non-woven material. The surface of the layer of foam or woven material constitutes the upper layer of the anchor pad 104 . In the alternative, the upper layer 105 may comprise an upper paper or other nonwoven layer, and an inner foam layer may be placed between the upper layer and the lower adhesive surface. In some embodiments, the anchor pad includes an antimicrobial additive. The anchor pads and retainers protect the patient's skin from irritation caused by medical devices rubbing against the skin.
锚定垫104被构造成固定到患者的皮肤。锚定垫104的下表面106上的粘合剂可以是医用级粘合剂并且可根据特定应用选择发汗或不发汗的粘合剂。下部粘合表面可具有层压到其上的额外类型的医用粘合剂，例如硅酮粘合剂。在一些实施方式中，下部粘合层包含抗菌材料或抗微生物材料。例如，下部粘合层可包括一种或多种微量动力的金属盐或金属氧化物，或盐与氧化物的组合。在一些实施方式中，下部粘合层包含银材料，例如银盐、银胶体或银复合物。粘合表面可为固体层，或可被构造为例如呈点或条图案的间歇层。在制造期间可将下部粘合表面施加到锚定垫104上，并且还可用如下文所述的衬件覆盖下部粘合表面。或者，在施加之前可将双面粘合带施加到上层。Anchor pad 104 is configured to be secured to the patient's skin. The adhesive on the lower surface 106 of the anchor pad 104 may be a medical grade adhesive and may be selected to be sweaty or non-sweaty depending on the particular application. The lower adhesive surface may have an additional type of medical adhesive, such as a silicone adhesive, laminated thereto. In some embodiments, the lower adhesive layer comprises an antimicrobial or antimicrobial material. For example, the lower adhesive layer may include one or more trace kinetic metal salts or metal oxides, or a combination of salts and oxides. In some embodiments, the lower adhesive layer comprises a silver material, such as a silver salt, silver colloid, or silver composite. The adhesive surface may be a solid layer, or may be configured as intermittent layers, for example in a pattern of dots or stripes. A lower adhesive surface may be applied to anchor pad 104 during manufacture and may also be covered with a liner as described below. Alternatively, a double-sided adhesive tape may be applied to the upper layer prior to application.
在图1中所示的实施方式中，锚定垫104在锚定垫104的下表面106上包括两个可移除衬件135和136。在使用之前，可移除衬件135和136可覆盖下部粘合表面。这两个衬件可抵抗撕裂，并且可被分成多片，以有助于移除衬件以及将锚定垫104轻松附着到患者的皮肤。衬件135和136可被分成两个相邻片。衬件135和136可由纸张、塑料、聚酯或类似材料制成。例如，衬件135和136可包含由聚合物涂覆的硅化纸张制成的材料，或另一合适的材料，诸如高密度聚乙烯、聚丙烯、聚烯烃或硅涂覆的纸。In the embodiment shown in FIG. 1 , the anchor pad 104 includes two removable liners 135 and 136 on the lower surface 106 of the anchor pad 104 . Removable liners 135 and 136 may cover the lower adhesive surface prior to use. The two liners are resistant to tearing and can be split into pieces to facilitate liner removal and easy attachment of the anchor pad 104 to the patient's skin. Liners 135 and 136 may be divided into two adjacent pieces. Liners 135 and 136 may be made of paper, plastic, polyester or similar material. For example, liners 135 and 136 may comprise a material made of polymer coated siliconized paper, or another suitable material such as high density polyethylene, polypropylene, polyolefin, or silicon coated paper.
如图1-2所示，剥离衬件135和136包括凸舌130，其延伸超过锚定垫104的边缘，以允许医疗提供者轻松地握持剥离衬件135和136，以及将剥离衬件从锚定垫104移除。凸舌130可位于锚定垫104的任何边缘处并且可为任何合适的大小或形状。如图1-2所示，在剥离衬件135和136之间的交界133处，剥离衬件136的一部分可在剥离衬件135的一部分的上方延伸。As shown in FIGS. 1-2 , release liners 135 and 136 include tabs 130 that extend beyond the edge of anchor pad 104 to allow a medical provider to easily grip release liners 135 and 136 and place the release liners Remove from anchor pad 104 . Tab 130 may be located at any edge of anchor pad 104 and may be of any suitable size or shape. As shown in FIGS. 1-2 , at interface 133 between release liners 135 and 136 , a portion of release liner 136 may extend over a portion of release liner 135 .
继续图1-2，衬件120可覆盖保持器101的粘合表面。该粘合表面可被构造以附着到敷料的部分和/或医疗制品的部分。衬件可覆盖保持器101的整个顶部表面，或可仅覆盖保持器101的粘合剂部分。如图1所示，衬件120的大小设定成覆盖整个保持器101并且还延伸超过保持器101的外周边。通过这种方式，衬件120的一部分可形成拉舌125。拉舌125可允许医疗保健提供者轻松握持衬件120并且从保持器101移除衬件120。衬件120可被制备成使得衬件120将保持器101的被覆盖表面维持在无菌状态中。在一些实施方式中，衬件120具有比保持器101长的尺寸，这确保衬件120始终悬伸超过保持器101的顶部边缘，以形成握持表面，供使用者用于移除衬件120。Continuing with FIGS. 1-2 , liner 120 may cover the adhesive surface of retainer 101 . The adhesive surface may be configured to attach to portions of the dressing and/or portions of the medical article. The liner may cover the entire top surface of the holder 101 , or may cover only the adhesive portion of the holder 101 . As shown in FIG. 1 , the liner 120 is sized to cover the entire holder 101 and also extend beyond the outer periphery of the holder 101 . In this way, a portion of liner 120 may form pull tab 125 . Pull tab 125 may allow a healthcare provider to easily grasp and remove liner 120 from retainer 101 . The liner 120 may be prepared such that the liner 120 maintains the covered surface of the holder 101 in a sterile state. In some embodiments, the liner 120 has a longer dimension than the holder 101, which ensures that the liner 120 always overhangs beyond the top edge of the holder 101 to form a gripping surface for the user to remove the liner 120 .
转到图3-4，保持器101被构造以接纳并且固定医疗制品的至少一部分。在图3-4的所示实施方式中，保持器101包括顶部表面102和被成形用于接纳医疗制品的至少一部分的凹陷部108。凹陷部108还包括延伸穿过保持器101的近侧的通道114。通道114可被成形用于接纳医疗制品的至少一部分。如图所示，通道可具有小于凹陷部的侧向宽度的侧向宽度。保持器101还可包括至少部分地在朝向通道114的方向上延伸的近侧邻接部110。近侧邻接部110可被成形用于接触医疗制品的至少一部分并且防止放置在凹陷部和/或通道内的医疗制品在至少近侧方向上的移动。在一些实施方式中，近侧邻接部设置在凹陷部108与通道114之间。Turning to FIGS. 3-4 , holder 101 is configured to receive and secure at least a portion of a medical article. In the illustrated embodiment of FIGS. 3-4 , the holder 101 includes a top surface 102 and a recess 108 shaped to receive at least a portion of the medical article. The recess 108 also includes a channel 114 extending through the proximal side of the retainer 101 . Channel 114 may be shaped to receive at least a portion of a medical article. As shown, the channel may have a lateral width that is less than the lateral width of the recess. The retainer 101 may also include a proximal abutment 110 extending at least partially in a direction towards the channel 114 . The proximal abutment 110 may be shaped to contact at least a portion of the medical article and prevent movement in at least a proximal direction of the medical article placed within the recess and/or channel. In some embodiments, the proximal abutment is disposed between the recess 108 and the channel 114 .
凹陷部还可包括远侧邻接部111。远侧邻接部111可由从锚定垫104的顶部表面向上延伸的一个或多个壁形成。远侧邻接部111可被成形用于接触医疗制品的至少一部分并且防止放置在凹陷部108和/或通道内的医疗制品在至少远侧方向上的移动。The recess may also include a distal abutment 111 . Distal abutment 111 may be formed by one or more walls extending upwardly from the top surface of anchor pad 104 . The distal abutment 111 can be shaped to contact at least a portion of the medical article and prevent movement in at least a distal direction of a medical article placed within the recess 108 and/or channel.
凹陷部108、通道114、近侧邻接部110、和/或远侧邻接部111可被设定大小并被成形用于拟合任何适当的医疗制品或其一部分。在一些实施方式中，凹陷部108、通道114、近侧邻接部110和/或远侧邻接部111被设定大小并被成形用于接纳医疗制品的不止一个类型和/或不止一个大小的部分。通过这种方式，本文所公开的固定系统可与多种医疗制品一起使用。多种多样的旋转螺母在医疗行业中使用，并且依据应用、地理位置和/或供应商可以有差别。此类旋转螺母的大小、形状和/或尺寸有差别。因此，本文所公开的固定系统可有利地提供被构造成固定不止一个旋转螺母实施方式的保持器。例如，凹陷部108、通道114、近侧邻接部110和/或远侧邻接部111可被设定大小并被成形，使得在第一旋转螺母插入凹陷部108内时，第一旋转螺母的面朝近侧的表面被放置成与近侧邻接部的面朝远侧的表面接触，而第一旋转螺母的面朝远侧的表面不接触远侧邻接部的面朝近侧的表面。当不同大小和/或形状的第二旋转螺母插入同一凹陷部108内时，第二旋转螺母的面朝近侧的表面被放置成与近侧邻接部的面朝远侧的表面接触，而第二旋转螺母的面朝远侧的表面也被放置成与远侧邻接部的面朝近侧的表面接触。通过这种方式，旋转螺母的一个或多个表面可紧靠保持器101的一个或多个邻接表面，这取决于正被固定的旋转螺母的大小和/或形状。因此，依据(例如)通道的长度和旋转螺母的长度，当该旋转螺母插入到保持器101中时，在旋转螺母的前面或后面可存在间隙或空间。在一些实施方式中，凹陷部108和通道114被设定大小并被成形为近似等于特定旋转螺母的大小和形状，使得该旋转螺母紧密地拟合在凹陷部108和通道114内。Recess 108, channel 114, proximal abutment 110, and/or distal abutment 111 may be sized and shaped to fit any suitable medical article or portion thereof. In some embodiments, the recess 108, channel 114, proximal abutment 110, and/or distal abutment 111 are sized and shaped to receive more than one type and/or more than one size of portion of a medical article . In this way, the fixation systems disclosed herein can be used with a variety of medical articles. A wide variety of swivel nuts are used in the medical industry and may vary by application, geographic location and/or supplier. Such swivel nuts vary in size, shape and/or dimensions. Accordingly, the securing systems disclosed herein may advantageously provide retainers configured to secure more than one spin nut embodiment. For example, recess 108, channel 114, proximal abutment 110, and/or distal abutment 111 may be sized and shaped such that when the first rotating nut is inserted into recess 108, the face of the first rotating nut The proximal facing surface is placed in contact with the distal facing surface of the proximal abutment, while the distal facing surface of the first spin nut does not contact the proximal facing surface of the distal abutment. When a second spin nut of a different size and/or shape is inserted into the same recess 108, the proximal-facing surface of the second spin nut is placed in contact with the distal-facing surface of the proximal abutment, while the second spin nut is placed in contact with the distal-facing surface of the proximal adjoining portion. The distal-facing surface of the two rotating nuts is also placed in contact with the proximal-facing surface of the distal abutment. In this way, one or more surfaces of the spin nut may abut against one or more abutment surfaces of the retainer 101, depending on the size and/or shape of the spin nut being secured. Thus, depending on, for example, the length of the channel and the length of the swivel nut, there may be a gap or space in front of or behind the swivel nut when the swivel nut is inserted into the holder 101 . In some embodiments, the recess 108 and channel 114 are sized and shaped to approximately equal the size and shape of a particular swivel nut such that the swivel nut fits snugly within the recess 108 and channel 114 .
在一些实施方式中，凹陷部108和/或通道114的内表面的至少一部分包括粘合剂。例如，粘合剂可设置在凹陷部108和/或通道114的下表面的至少一部分上、和/或形成凹陷部108和/或通道114的内部壁的至少一部分上。保持器101的其他表面也可包括粘合剂。例如，在一些实施方式中，形成凹陷部108的向上延伸壁的顶部表面102的至少一部分包括粘合剂。该粘合剂可类似于结合锚定垫104所述的粘合剂。该粘合剂可附着到放置在保持器101内的医疗制品的一个或多个表面，以进一步限制医疗制品的移动。保持器101可包含各种材料，例如，一种或多种弹性体。在一些实施方式中，保持器101包括被构造成允许轻松移除封闭包扎物和/或绷带的材料。In some embodiments, at least a portion of the interior surface of the recess 108 and/or the channel 114 includes an adhesive. For example, an adhesive may be disposed on at least a portion of a lower surface of the recess 108 and/or channel 114 and/or on at least a portion of an interior wall forming the recess 108 and/or channel 114 . Other surfaces of holder 101 may also include adhesive. For example, in some embodiments, at least a portion of the top surface 102 of the upwardly extending wall forming the recess 108 includes an adhesive. The adhesive may be similar to that described in connection with anchor pad 104 . The adhesive can be attached to one or more surfaces of a medical article placed within holder 101 to further restrict movement of the medical article. Retainer 101 may comprise various materials, for example, one or more elastomers. In some embodiments, retainer 101 comprises a material configured to allow easy removal of the occlusive dressing and/or bandage.
图5是图1的固定装置的分解图。衬件120可设置在保持器101的上表面102上。保持器101的上表面102可包括粘合剂。该粘合剂可被构造以阻止放置成与保持器101的上表面102接触的医疗制品的移动。在一些实施方式中，保持器101的上表面102包括粘合剂，使得医疗装置可稳定在保持器101上，从而允许使用者放开医疗装置，用手完成安装。保持器101和衬件120可设置在锚定垫104上。锚定垫104的底部表面106的至少一部分可包括粘合剂。可移除衬件135和136可设置在锚定垫104的底部表面106上，以覆盖粘合表面。衬件135和136可移除，并且锚定垫104可固定到患者的皮肤。FIG. 5 is an exploded view of the fixing device of FIG. 1 . A liner 120 may be disposed on the upper surface 102 of the holder 101 . The upper surface 102 of the holder 101 may include an adhesive. The adhesive may be configured to resist movement of a medical article placed in contact with the upper surface 102 of the holder 101 . In some embodiments, the upper surface 102 of the holder 101 includes an adhesive such that the medical device can be stabilized on the holder 101, thereby allowing the user to release the medical device and complete the installation by hand. Retainer 101 and liner 120 may be disposed on anchor pad 104 . At least a portion of the bottom surface 106 of the anchor pad 104 may include an adhesive. Removable liners 135 and 136 may be disposed on the bottom surface 106 of the anchor pad 104 to cover the adhesive surface. Liners 135 and 136 can be removed and anchor pad 104 can be secured to the patient's skin.
转到图6，其显示保持器101和锚定垫104的平面图。保持器101包括凹陷部108、通道114、近侧邻接部110和远侧邻接部111。凹陷部108可为任何合适的大小和形状。如图所示，凹陷部108具有大于从凹陷部108在近侧方向上延伸的通道114的宽度的宽度。它们之间的宽度差可形成邻接部110。换句话讲，邻接部110可延伸到凹陷部108的近侧部分中，以形成宽度比凹陷部108窄的通道114。通过这种方式，保持器101可将医疗制品的至少一部分接纳在通道114的至少一部分中和/或凹陷部108的至少一部分中。此外，医疗制品的面朝近侧的表面的至少一部分可紧靠邻接部110的面朝远侧的表面。通过这种方式，邻接部110可防止放置在保持器101内的医疗制品至少在近侧方向上的移动，同时远侧邻接部111可防止其至少在远侧方向上的移动。在一些实施方式中，凹陷部108的宽度为约7mm，而通道114的宽度为约4mm。Turning to FIG. 6 , a plan view of retainer 101 and anchor pad 104 is shown. The retainer 101 includes a recess 108 , a channel 114 , a proximal abutment 110 and a distal abutment 111 . Recess 108 may be of any suitable size and shape. As shown, the recess 108 has a width that is greater than the width of the channel 114 extending from the recess 108 in the proximal direction. The difference in width between them may form the abutment 110 . In other words, the abutment 110 may extend into a proximal portion of the recess 108 to form a channel 114 that is narrower in width than the recess 108 . In this manner, retainer 101 may receive at least a portion of the medical article within at least a portion of channel 114 and/or within at least a portion of recess 108 . Additionally, at least a portion of the proximal-facing surface of the medical article may abut the distal-facing surface of the abutment portion 110 . In this way, the abutment 110 prevents movement of the medical article placed within the holder 101 at least in the proximal direction, while the distal abutment 111 prevents movement thereof at least in the distal direction. In some embodiments, the width of the recess 108 is about 7 mm and the width of the channel 114 is about 4 mm.
如图7所示，医疗制品200可放置在保持器101内。该医疗制品可包括导管210和连接到延长套件220的导管套节230。本领域技术人员大致都知道导管套节。图7中所示的导管套节230具有近侧主体232和远侧主体212。然而，不同的导管套节可或多或少地包括具有各种不同形状和大小的主体部分，所有这些均可与保持器或本文所述的保持器的其它实施方式一起使用。图7所示的延长套件220包括连接到连接器225的旋转螺母244，其中连接器225结合到医用管222。在某些实施方式中，导管套节230包括一体的单向阀。在一些实施方式中，保持器101被构造成将医疗制品200悬置在患者的皮肤上方，以允许导管相对于患者的皮肤以某一角度(例如，以7度的角度)插入到患者的皮肤中。例如，如图7所示，保持器101可被设定大小并被成形，使得医疗制品的后部由保持器101的远侧部分支承。在一些实施方式中，远侧邻接部111既可相对于医疗制品的近侧部分悬置医疗制品的远侧部分，又可通过紧靠医疗制品的面朝远侧的表面来防止医疗制品在至少远侧方向上的移动。As shown in FIG. 7 , a medical article 200 may be placed within a holder 101 . The medical article may include catheter 210 and catheter hub 230 connected to extension set 220 . Catheter hubs are generally known to those skilled in the art. Catheter hub 230 shown in FIG. 7 has a proximal body 232 and a distal body 212 . However, different catheter hubs may include more or less body portions of various shapes and sizes, all of which may be used with retainers or other embodiments of retainers described herein. The extension set 220 shown in FIG. 7 includes a swivel nut 244 connected to a connector 225 that is coupled to the medical tubing 222 . In certain embodiments, catheter hub 230 includes an integral one-way valve. In some embodiments, the retainer 101 is configured to suspend the medical article 200 above the patient's skin to allow the catheter to be inserted into the patient's skin at an angle (eg, at an angle of 7 degrees) relative to the patient's skin middle. For example, as shown in FIG. 7 , retainer 101 may be sized and shaped such that the rear portion of the medical article is supported by the distal portion of retainer 101 . In some embodiments, the distal abutment 111 can both suspend the distal portion of the medical article relative to the proximal portion of the medical article and prevent the medical article from Movement in the distal direction.
在图7所示的实施方式中，凹陷部108被成形用于接纳旋转螺母244的一部分，并且通道114被成形用于接纳导管套节230的远侧主体212的一部分。通过这种方式，旋转螺母244的近侧表面可紧靠邻接部110的远侧表面。换句话讲，旋转螺母244的近侧表面可紧靠保持器101的远侧表面，以防止导管200在朝向患者的近侧方向上的移动。In the embodiment shown in FIG. 7 , recess 108 is shaped to receive a portion of spin nut 244 and channel 114 is shaped to receive a portion of distal body 212 of catheter hub 230 . In this way, the proximal surface of the spin nut 244 can abut against the distal surface of the abutment 110 . In other words, the proximal surface of the spin nut 244 can abut the distal surface of the retainer 101 to prevent movement of the catheter 200 in the proximal direction towards the patient.
凹陷部108和/或通道114可被成形用于接纳医疗制品200的不同部分。例如，在一些实施方式中，通道114和凹陷部108被成形用于接纳连接器225。在该实施方式中，邻接部110的远侧表面可接触连接器225的面朝近侧的表面，以防止导管200在近侧方向上的移动。通过这种方式，旋转螺母244不由保持器101固定，并且因此，旋转螺母244可在导管套节230保持固定到患者的同时被旋转以从导管套节230释放延长套件220。Recess 108 and/or channel 114 may be shaped to receive different portions of medical article 200 . For example, in some embodiments, channel 114 and recess 108 are shaped to receive connector 225 . In this embodiment, the distal surface of the abutment 110 can contact the proximally facing surface of the connector 225 to prevent movement of the catheter 200 in the proximal direction. In this way, the swivel nut 244 is not secured by the retainer 101 , and thus, the swivel nut 244 can be rotated to release the extension set 220 from the catheter hub 230 while the catheter hub 230 remains secured to the patient.
转到图8-9，其显示可与上文所述的固定装置一起使用的敷料400。敷料400包括闭合层418、至少部分地被粘合剂覆盖的下表面、以及覆盖敷料400的下表面的两个剥离衬件435和436。粘合剂被构造成附着到患者的皮肤、和/或锚定垫的部分、保持器的部分和/或医疗制品的部分。敷料400包括插入窗口426和保持器窗口425。该敷料还包括通道450和被成形用于接纳医用管222的开口455。如图所示，剥离衬件435和436从敷料的下表面向外突出并且形成拉舌437和439。Turning to Figures 8-9, there is shown a dressing 400 that may be used with the fixation devices described above. Dressing 400 includes an occlusive layer 418 , a lower surface at least partially covered by adhesive, and two release liners 435 and 436 covering the lower surface of dressing 400 . The adhesive is configured to adhere to the patient's skin, and/or to portions of the anchor pad, retainer, and/or medical article. The dressing 400 includes an insertion window 426 and a retainer window 425 . The dressing also includes a channel 450 and an opening 455 shaped to receive the medical tube 222 . As shown, release liners 435 and 436 protrude outwardly from the lower surface of the dressing and form pull tabs 437 and 439 .
剥离衬件435和436可覆盖设置在敷料400的下表面上的粘合剂。剥离衬件435和436可覆盖敷料的整个下表面或可仅覆盖粘合表面。剥离衬件435和436可包括抗微生物或抗菌的材料或涂层，和/或具有遍布分散的银颗粒。敷料400以及剥离衬件435和436可被制备成使得剥离衬件435和436将闭合层的被覆盖表面维持在无菌状态中。在一些实施方式中，仅使用一个剥离衬件。Release liners 435 and 436 may cover the adhesive disposed on the lower surface of dressing 400 . Release liners 435 and 436 may cover the entire lower surface of the dressing or may cover only the adhesive surface. Release liners 435 and 436 may include an antimicrobial or antimicrobial material or coating, and/or have silver particles dispersed throughout. Dressing 400 and release liners 435 and 436 may be prepared such that release liners 435 and 436 maintain the covered surface of the occlusion layer in a sterile state. In some embodiments, only one release liner is used.
在一些实施方式中，在敷料400的底部表面上，至少围绕插入窗口426的周边以及围绕保持器窗口425的周边包括粘合剂。在一些实施方式中，粘合剂覆盖敷料400的整个底部表面，但是由插入窗口426和保持器窗口425形成的区域除外。在一些实施方式中，敷料400的底部表面上的粘合剂被设置成使得敷料400将不在插入点处附着。通过这种方式，可降低恶化或擦破插入部位或插入部位周围的皮肤、和/或在插入点附近或向插入点中引入污染物和/或液体的可能性。另外，敷料400的底部表面上的粘合剂可被设置成使得粘合层将不附着或粘附到导管和/或导管套节。通过这种方式，可减少或避免导管和导管套节上的粘性残留物和粘性积聚物。在其它实施方式中，粘合剂覆盖敷料400的整个底部表面，包括插入窗口426和保持器窗口425。In some embodiments, adhesive is included on the bottom surface of the dressing 400 at least around the perimeter of the insertion window 426 and around the perimeter of the retainer window 425 . In some embodiments, the adhesive covers the entire bottom surface of dressing 400 , except for the area formed by insertion window 426 and retainer window 425 . In some embodiments, the adhesive on the bottom surface of the dressing 400 is configured such that the dressing 400 will not adhere at the point of insertion. In this manner, the likelihood of aggravating or chafing the insertion site or the skin surrounding the insertion site, and/or introducing contaminants and/or fluids near or into the insertion point may be reduced. Additionally, the adhesive on the bottom surface of the dressing 400 may be configured such that the adhesive layer will not adhere or adhere to the catheter and/or catheter hub. In this way, sticky residue and sticky buildup on the catheter and catheter hub can be reduced or avoided. In other embodiments, the adhesive covers the entire bottom surface of the dressing 400 , including the insertion window 426 and the retainer window 425 .
如上所述，敷料400包括通道450和开口455。通道450和开口455允许将敷料施加到医疗制品上。敷料400可被构造成在导管和/或导管套节上方施加到患者的皮肤时围绕插入部位提供防水密封。在一些实施方式中，尽管形成了防水密封，但敷料400仍为可透气的。在一些实施方式中，敷料400以类似于锚定垫104的方式进行构造。As mentioned above, dressing 400 includes channels 450 and openings 455 . Channel 450 and opening 455 allow the dressing to be applied to the medical article. Dressing 400 may be configured to provide a watertight seal around the insertion site when applied to the patient's skin over the catheter and/or catheter hub. In some embodiments, the dressing 400 is breathable despite forming a watertight seal. In some embodiments, dressing 400 is configured in a manner similar to anchor pad 104 .
在一些实施方式中，敷料400包括止血敷料。在此类实施方式中，将敷料400固定在插入部位或其他伤口上可防止血液从插入部位流出。例如，敷料400可包含或涂覆有止血剂或抗出血剂，诸如脱乙酰壳多糖或其他多糖、胶原蛋白(如微纤丝止血剂)、无水硫酸铝、钾明矾、二氧化钛、明胶或凝血酶溶液。在一些实施方式中，还提供具有止血和抗微生物性质的小薄垫。此类垫可被构造成围绕导管和/或覆盖插入部位。在一些实施方式中，抗微生物/止血垫与保持器101或锚定垫104成一整体，以提高放置该垫的容易度。在一些实施方式中，该垫由称为的材料制成。在一些实施方式中，敷料包括抗微生物添加剂。In some embodiments, dressing 400 includes a hemostatic dressing. In such embodiments, securing the dressing 400 over the insertion site or other wound prevents blood flow from the insertion site. For example, dressing 400 may contain or be coated with hemostatic or anti-bleeding agents such as chitosan or other polysaccharides, collagen (eg, microfibrillar hemostats), anhydrous aluminum sulfate, potassium alum, titanium dioxide, gelatin, or coagulation enzyme solution. In some embodiments, a small pad with hemostatic and antimicrobial properties is also provided. Such pads may be configured to surround the catheter and/or cover the insertion site. In some embodiments, the antimicrobial/hemostatic pad is integral to the retainer 101 or anchor pad 104 to improve ease of placement of the pad. In some embodiments, the pad is called made of materials. In some embodiments, the dressing includes an antimicrobial additive.
图10是敷料400的分解图。如图所示，闭合层418可设置在敷料400的顶部表面408上。敷料400的底部表面406可至少部分地被粘合剂覆盖。剥离衬件435和436可设置在敷料400的底部表面406上。如图所示，敷料400的闭合层418、顶部表面408和剥离衬件435包括通道和开口。在一些实施方式中，闭合层418的底部表面419至少部分地被粘合剂覆盖。另外，剥离衬件435可包括接触剥离衬件436的一部分437的折叠部分439。通过这种方式，拉舌439完全被剥离衬件436覆盖。因此，鼓励医疗保健提供者首先握持剥离衬件436的部分437，以鼓励恰当的放置技术。在敷料400的前部或顶部附接到皮肤之后，医疗保健提供者接着可握持折叠部分439来移除剥离衬件435。FIG. 10 is an exploded view of dressing 400 . As shown, an occlusive layer 418 may be disposed on the top surface 408 of the dressing 400 . The bottom surface 406 of the dressing 400 may be at least partially covered by the adhesive. Release liners 435 and 436 may be disposed on bottom surface 406 of dressing 400 . As shown, the occlusive layer 418, top surface 408, and release liner 435 of the dressing 400 include channels and openings. In some embodiments, the bottom surface 419 of the closure layer 418 is at least partially covered by the adhesive. Additionally, release liner 435 may include folded portion 439 that contacts a portion 437 of release liner 436 . In this way, pull tab 439 is completely covered by release liner 436 . Accordingly, healthcare providers are encouraged to hold portion 437 of release liner 436 first to encourage proper placement technique. After the front or top of the dressing 400 is attached to the skin, the healthcare provider can then grasp the folded portion 439 to remove the release liner 435 .
闭合层418可被构造成防水的或以其他方式不能被液体透过，并且在一些实施方式中还限制空气的流动。在其它实施方式中，闭合层418可被构造成可透气的，从而允许插入部位附近的空气和/或水分穿过闭合层418而到达另一侧并且远离插入部位，同时使至少闭合层418的另一侧上的外部水分保持远离插入部位。在一些实施方式中，闭合层418不可渗透病毒和细菌，并且可包含或涂覆有抗菌材料或抗微生物材料。在一些实施方式中，闭合层418包含或涂覆有蜡质材料。在一些实施方式中，闭合层418包括膜，该膜可以是透明的，也可以是不透明。The closure layer 418 may be constructed to be waterproof or otherwise liquid impermeable, and in some embodiments also restrict the flow of air. In other embodiments, the occlusive layer 418 can be configured to be breathable, thereby allowing air and/or moisture near the insertion site to pass through the occlusive layer 418 to the other side and away from the insertion site while keeping at least the occlusive layer 418 External moisture on the other side is kept away from the insertion site. In some embodiments, the occlusive layer 418 is impermeable to viruses and bacteria, and may contain or be coated with an antimicrobial or antimicrobial material. In some embodiments, the occlusive layer 418 comprises or is coated with a waxy material. In some embodiments, the occlusive layer 418 comprises a film, which may be transparent or opaque.
选择透明膜或半透明膜用作闭合层418，可允许医疗提供者通过敷料中的插入窗口看到插入部位。通过这种方式，可通过透明膜看到潜在的感染或炎症。使用透明膜或半透明膜作为闭合层418，还可允许医疗提供者看到任何所施用导管，以确保维持流体连接。Selection of a transparent or translucent film for the occlusive layer 418 may allow the medical provider to see the insertion site through the insertion window in the dressing. In this way, underlying infection or inflammation can be seen through the transparent membrane. Using a transparent or translucent film as the closure layer 418 may also allow the medical provider to see any catheter applied to ensure that the fluid connection is maintained.
在一些实施方式中，闭合层418是吸收性的(absorbent)。在一些实施方式中，闭合层418包含吸收性丙烯酸树脂、海藻酸盐、泡沫、水性胶体和/或水凝胶材料，和/或可包含银材料，例如银盐、银胶体或银复合物。在一个实施方式中，在闭合层418中或其上使用一种或多种微量动力的金属盐或金属氧化物，或盐与氧化物的组合作为抗微生物剂。在一些实施方式中，闭合层418被构造成类似于锚定垫104的上层。In some embodiments, the occlusive layer 418 is absorbent. In some embodiments, the occlusive layer 418 comprises absorbent acrylics, alginates, foams, hydrocolloids, and/or hydrogel materials, and/or may comprise silver materials, such as silver salts, silver colloids, or silver composites. In one embodiment, one or more microkinetic metal salts or metal oxides, or a combination of salts and oxides, are used in or on the occlusive layer 418 as an antimicrobial agent. In some embodiments, the occlusive layer 418 is configured similarly to the upper layer of the anchor pad 104 .
图11中显示敷料400的平面图。如图所示，通道450从敷料的远端延伸，终止于开口455处。在某些实施方式中，开口455为大致圆形形状，并且具有大于通道450的宽度的直径。通过这种方式，医用管可滑动穿过通道450并且搁置在开口455内。因此，敷料可更容易地放置在医疗制品上方。敷料400在其远端附近的侧中还具有凹口或压痕458。这些凹口458可定位穿孔428。穿孔428可允许敷料的远侧部分容易地从敷料的其余部分移除。A plan view of dressing 400 is shown in FIG. 11 . As shown, channel 450 extends from the distal end of the dressing, terminating at opening 455 . In certain embodiments, the opening 455 is generally circular in shape and has a diameter that is greater than the width of the channel 450 . In this way, the medical tubing can slide through channel 450 and rest within opening 455 . Thus, the dressing can be placed over the medical article more easily. The dressing 400 also has a notch or indentation 458 in the side near its distal end. These notches 458 may locate the perforations 428 . Perforations 428 may allow the distal portion of the dressing to be easily removed from the remainder of the dressing.
在操作中，使用上文所述的固定装置和敷料的方法以及用于将医疗制品连接到患者的过程可通过移除覆盖保持器101的衬件120而开始，如图12A和13-14所示。衬件120可覆盖保持器101的一个或多个粘合表面。在一些实施方式中，保持器101的整个上表面102均涂覆有粘合剂。如图所示，附接到锚定垫104的表面的衬件135和136可包括凸舌130，凸舌130具有指向插入部位的一个或多个箭头，使得医疗提供者可恰当地使固定装置取向。In operation, the method of using the fixation devices and dressings described above and the process for attaching a medical article to a patient may begin by removing the liner 120 covering the retainer 101, as shown in FIGS. 12A and 13-14. Show. Liner 120 may cover one or more adhesive surfaces of retainer 101 . In some embodiments, the entire upper surface 102 of the holder 101 is coated with adhesive. As shown, the liners 135 and 136 attached to the surface of the anchor pad 104 may include tabs 130 with one or more arrows pointing towards the insertion site so that the medical provider can properly position the fixation device. orientation.
如图12A-D所示，衬件凸舌130可包括编号，以指示从固定装置移除衬件时应遵循的次序，以及包括信息，例如“移除”，以指示在使用固定装置之前应移除衬件。图12A显示了一个实施方式，衬件120的拉舌112在箭头内部包括“1”，并且衬件135和136的拉舌130在箭头内部包括“2”以区别于拉舌112。如上所讨论的，箭头可被定位以便它们向医疗提供者指示固定装置的适当取向。图12B显示了衬件121的一个实施方式，包括在纯色带(例如黑色)上具有数字“1”的拉舌113，被圈围的信息115“移除(Remove)”重复遍及衬件的可视表面。形成圈围区域的线条以及信息115中的文本可以是相同颜色，其在一个实施方式中可与拉舌113的纯色带相配。图12C显示覆盖锚定垫的下表面的一部分的衬件137的一个实施方式，并且图12D显示了覆盖锚定垫的下表面的另一部分的衬件138的一个实施方式。衬件137和138均可具有拉舌139用的相同纯色带(例如绿色)，并且包括重复遍及衬件的可视表面的被圈围的信息115“移除”。在一个实施方式中，衬件137和138彼此具有相同的配色方案(例如，拉舌用的纯色带、线条和文本)，并且在另一个实施方式中，配色方案不相同。在一个实施方式中，衬件137和138的配色方案(无论不同还是相同)不同于衬件121的配色方案，从而进一步将衬件彼此区分开。As shown in Figures 12A-D, the liner tabs 130 may include a number to indicate the order to be followed when removing the liner from the fixture, as well as information such as "remove" to indicate that the liner should be removed before using the fixture. Remove the liner. FIG. 12A shows an embodiment where tab 112 of liner 120 includes a "1" inside the arrow, and tab 130 of liners 135 and 136 includes a "2" inside the arrow to distinguish it from tab 112 . As discussed above, the arrows can be positioned so that they indicate the proper orientation of the fixation device to the medical provider. Figure 12B shows an embodiment of a liner 121 comprising a pull tab 113 with the numeral "1" on a solid colored band (e.g. black) with the encircled message 115 "Remove (Remove)" repeated throughout the liner's optional depending on the surface. The lines forming the enclosed area and the text in the message 115 may be the same color, which in one embodiment may match the solid color band of the pull tab 113 . Figure 12C shows one embodiment of a liner 137 covering a portion of the lower surface of the anchor pad, and Figure 12D shows an embodiment of a liner 138 covering another portion of the lower surface of the anchor pad. Both liners 137 and 138 may have the same solid color band (eg green) for the pull tab 139 and include the encircled message 115 "Remove" repeated throughout the visible surface of the liner. In one embodiment, liners 137 and 138 have the same color scheme as each other (eg, solid color bands for the tabs, lines, and text), and in another embodiment, the color schemes are different. In one embodiment, the color scheme of liners 137 and 138 (whether different or the same) differs from the color scheme of liner 121 to further differentiate the liners from one another.
该过程可通过移除覆盖锚定垫104的下部粘合表面的衬件并且将医疗制品放置在保持器101内而继续，如图15-19所示。如图16所示，覆盖下部粘合表面的衬件可包括两个衬件135和136，它们覆盖下部粘合表面的约一半。这两个衬件可从两个衬件的交界133向后折叠，并且从下部粘合表面延伸出来，以形成拉舌130。通过这种方式，医疗提供者不太可能用手接触下部粘合表面并且危及下部粘合表面的无菌性。在一些实施方式中，医疗提供者用每只手各握持一个凸舌并且部分地移除衬件。医疗提供者接着通过使锚定垫朝向患者的皮肤移动同时拉动凸舌以完全地移除衬件，将锚定垫放置在患者身上。The process may continue by removing the liner covering the lower adhesive surface of the anchor pad 104 and placing the medical article within the holder 101, as shown in Figures 15-19. As shown in FIG. 16, the liner covering the lower bonding surface may include two liners 135 and 136 covering about half of the lower bonding surface. The two liners can be folded back from the interface 133 of the two liners and extend from the lower adhesive surface to form the pull tab 130 . In this way, the medical provider is less likely to touch the lower adhesive surface with his hands and compromise the sterility of the lower adhesive surface. In some embodiments, the medical provider holds one tab in each hand and partially removes the liner. The medical provider then places the anchor pad on the patient by moving the anchor pad toward the patient's skin while pulling on the tab to completely remove the liner.
在图17的所示实施方式中，固定装置在医疗制品200下方滑动，并且一个衬件135被移除。该医疗制品包括旋转螺母244。旋转螺母244至少部分地设置在保持器101中形成的凹陷部108和通道内。在某些实施方式中，旋转螺母244的近侧表面接触保持器101的远侧表面。可向旋转螺母244施加向下压力，使得旋转螺母244的底部表面被按压至接触凹陷部的底部表面。设置在保持器101的上表面102上和/或凹陷部内的粘合剂，可进一步将医疗制品固定到保持器101并且防止医疗制品相对于保持器在任何方向上的移动。In the illustrated embodiment of Fig. 17, the securing device is slid under the medical article 200, and one liner 135 is removed. The medical article includes a swivel nut 244 . The swivel nut 244 is at least partially disposed within the recess 108 and channel formed in the retainer 101 . In certain embodiments, the proximal surface of the spin nut 244 contacts the distal surface of the retainer 101 . Downward pressure may be applied to the swivel nut 244 such that the bottom surface of the swivel nut 244 is pressed to contact the bottom surface of the recess. Adhesive disposed on the upper surface 102 of the holder 101 and/or within the recess may further secure the medical article to the holder 101 and prevent movement of the medical article relative to the holder in any direction.
该过程可通过移除覆盖锚定垫104的下部粘合表面106的第二衬件136而继续，如图18-19所示。通过这种方式，锚定垫104被固定到患者的皮肤。可以任何次序完成移除衬件和将医疗制品插入保持器内。在一些实施方式中，两个衬件基本上同时移除。另外，可在将医疗制品插入到患者体内之前或之后将医疗制品放置在保持器内。可在将医疗装置至少部分地插入到患者体内之前或之后将固定装置附接到患者。The process may continue by removing the second liner 136 covering the lower adhesive surface 106 of the anchor pad 104, as shown in FIGS. 18-19. In this way, anchor pad 104 is secured to the patient's skin. Removing the liner and inserting the medical article into the holder can be accomplished in any order. In some embodiments, both liners are removed substantially simultaneously. Additionally, the medical article can be placed in the holder either before or after insertion of the medical article into the patient. The fixation device may be attached to the patient either before or after the medical device is at least partially inserted into the patient.
在一些实施方式中，将医疗制品固定到患者的过程可通过以下操作而继续：获取粘合敷料，移除敷料的衬件，和将敷料放置在固定装置和插入部位上方，如图20-26所示。图20显示敷料400的顶部透视图，并且图21显示敷料400的底部透视图。医疗提供者可抓住衬件436在衬件435的折叠部分439上方延伸的一部分437。在一些实施方式中，医疗提供者可同时抓住衬件436的部分437和衬件435的折叠部分439。然而，如图22所示，可首先移除衬件436，以暴露透明或部分透明的插入窗口426、透明或部分透明的保持器窗口425、和粘合表面406。在一些实施方式中，衬件436的一部分438覆盖保持器窗口425的至少一部分。如此，当在放置期间移除衬件436时，执业医生可透过透明保持器窗口425的至少一部分查看医疗装置并且辅助恰当放置敷料。接着可移除剥离衬件435，如图23-24所示。In some embodiments, the process of securing the medical article to the patient may continue by obtaining an adhesive dressing, removing the lining of the dressing, and placing the dressing over the fixation device and insertion site, as shown in FIGS. 20-26 shown. FIG. 20 shows a top perspective view of dressing 400 , and FIG. 21 shows a bottom perspective view of dressing 400 . A medical provider may grasp a portion 437 of liner 436 that extends over folded portion 439 of liner 435 . In some embodiments, a medical provider can grasp portion 437 of liner 436 and folded portion 439 of liner 435 simultaneously. However, as shown in FIG. 22 , liner 436 may be removed first to expose transparent or partially transparent insertion window 426 , transparent or partially transparent retainer window 425 , and adhesive surface 406 . In some embodiments, a portion 438 of the liner 436 covers at least a portion of the retainer window 425 . As such, when liner 436 is removed during placement, a medical practitioner can view the medical device through at least a portion of transparent retainer window 425 and assist in proper dressing placement. The release liner 435 can then be removed, as shown in Figures 23-24.
将衬件从敷料400至少部分地移除之后，可将敷料放置在插入部位上方并且借助敷料400下侧上的合适的粘合表面406将敷料附着到患者，如图25-26所示。在一些实施方式中，敷料被构造成防水的或以其他方式不能被液体透过，并且在一些实施方式中，敷料还限制空气的流动。在其它实施方式中，敷料可被构造成可透气的，从而允许插入部位附近的空气和/或水分穿过敷料而到达另一侧并且远离插入部位，同时使至少敷料的另一侧上的外部水分保持远离插入部位。在一些实施方式中，敷料不可渗透病毒和细菌，并且可包含或涂覆有抗菌材料或抗微生物材料。在一些实施方式中，敷料包含或涂覆有蜡质材料。覆盖医疗装置的敷料以及位于医疗装置下方的锚定垫和保持器的组合可创制对医疗装置的360度固定。After the liner is at least partially removed from the dressing 400, the dressing can be placed over the insertion site and attached to the patient by means of a suitable adhesive surface 406 on the underside of the dressing 400, as shown in Figures 25-26. In some embodiments, the dressing is constructed to be waterproof or otherwise liquid impervious, and in some embodiments, the dressing also restricts the flow of air. In other embodiments, the dressing can be configured to be breathable, thereby allowing air and/or moisture near the insertion site to pass through the dressing to the other side and away from the insertion site, while keeping at least the outer surface on the other side of the dressing Moisture is kept away from the insertion site. In some embodiments, the dressing is impermeable to viruses and bacteria, and may contain or be coated with an antimicrobial or antimicrobial material. In some embodiments, the dressing comprises or is coated with a waxy material. The combination of the dressing covering the medical device and the anchor pads and retainer underlying the medical device can create a 360 degree fixation of the medical device.
如图26所示，可通过窗口425和426看到插入部位和医疗制品的至少一部分。另外，医用管路222可穿过敷料远侧的通道450，以搁置在开口455内。因此，敷料的一部分可在敷料的远端处围绕医用管路222闭合。通过这种方式，防止流体、食物和/或其他污染物进入插入部位。As shown in FIG. 26 , at least a portion of the insertion site and medical article can be seen through windows 425 and 426 . In addition, the medical tubing 222 can pass through the channel 450 on the distal side of the dressing to rest within the opening 455 . Accordingly, a portion of the dressing may be closed around the medical tubing 222 at the distal end of the dressing. In this way, fluid, food and/or other contaminants are prevented from entering the insertion site.
为移除远侧部分敷料并且释放医用管222，医疗提供者可沿着由凹口458定位的穿孔428撕裂并且移除敷料的远侧部分。在一些实施方式中，固定装置、敷料和/或胶带包括在套件中。该套件还可包括用于使用套件组件的说明。To remove the distal portion of the dressing and release the medical tube 222 , a medical provider may tear along the perforation 428 located by the notch 458 and remove the distal portion of the dressing. In some embodiments, the fixation device, dressing and/or tape are included in the kit. The kit may also include instructions for using the kit components.
现在参考图27-28，固定装置500的实施方式包括锚定垫104、保持器102和折翼510。锚定垫104被构造成固定到患者的皮肤。在一些实施方式中，锚定垫104的下表面106的至少一部分包括粘合剂。保持器102被构造以接纳并且固定医疗制品的至少一部分。在图27-28的所示实施方式中，保持器102包括被成形用于接纳医疗制品的至少一部分的凹陷部108。在一些实施方式中，保持器108的上表面的至少一部分包括粘合剂。折翼510被构造成折叠到保持器102上方。Referring now to FIGS. 27-28 , an embodiment of a fixation device 500 includes an anchor pad 104 , a retainer 102 and a flap 510 . Anchor pad 104 is configured to be secured to the patient's skin. In some embodiments, at least a portion of the lower surface 106 of the anchor pad 104 includes an adhesive. Retainer 102 is configured to receive and secure at least a portion of a medical article. In the illustrated embodiment of FIGS. 27-28 , the holder 102 includes a recess 108 shaped to receive at least a portion of the medical article. In some embodiments, at least a portion of the upper surface of the holder 108 includes an adhesive. Flap 510 is configured to fold over holder 102 .
现在参考折翼510，在图27中可看出，折翼510附接到固定装置500和/或与固定装置500一体化。折翼510被构造成向下折叠、弯曲或旋转到保持器102上方。折翼510和锚定垫104和/或保持器102可形成为一体的单件。或者，折翼510和锚定垫104可独立地形成，之后附接在一起。在这种情况下，折翼510和锚定垫104可通过允许折翼510向下折叠、弯曲或旋转到保持器102上方的任何装置或机构来附接。附接装置包括胶或粘合剂、材料焊接、热密封、机械紧固件(诸如U形钉或孔眼)或其他此类附接装置。Referring now to flap 510 , as can be seen in FIG. 27 , flap 510 is attached to and/or integral with securing device 500 . Flap 510 is configured to fold down, bend or rotate over holder 102 . Flap 510 and anchor pad 104 and/or retainer 102 may be formed as an integral, single piece. Alternatively, flaps 510 and anchor pads 104 may be formed separately and then attached together. In this case, flap 510 and anchor pad 104 may be attached by any device or mechanism that allows flap 510 to fold down, bend, or rotate over retainer 102 . Attachment means include glue or adhesives, material welding, heat sealing, mechanical fasteners such as staples or eyelets, or other such attachment means.
衬件513可覆盖折翼510的粘合表面。该粘合表面被构造以附着到医疗制品、保持器102的部分、医疗制品的部分、和/或附着到锚定垫104的上表面的部分。衬件513可覆盖折翼510的整个表面或可仅覆盖折翼510的粘合剂部分。折翼510和衬件513可被制备成使得衬件513将折翼510的被覆盖表面维持在无菌状态中。如图28所示，衬件513包括凸舌512。凸舌512可允许医疗保健提供者容易地握持衬件513的一部分并且将衬件513拉离折翼510的上表面，由此移除衬件513，使粘合表面暴露。凸舌512可与衬件513成一整体，并且在一些实施方式中，包括衬件513的折叠部分。Liner 513 may cover the adhesive surface of flap 510 . The adhesive surface is configured to adhere to a medical article, a portion of the retainer 102 , a portion of the medical article, and/or to a portion of the upper surface of the anchor pad 104 . Liner 513 may cover the entire surface of flap 510 or may only cover the adhesive portion of flap 510 . Flap 510 and liner 513 may be prepared such that liner 513 maintains the covered surface of flap 510 in a sterile state. As shown in FIG. 28 , liner 513 includes tab 512 . Tab 512 may allow a healthcare provider to easily grasp a portion of liner 513 and pull liner 513 away from the upper surface of flap 510, thereby removing liner 513 and exposing the adhesive surface. Tab 512 may be integral with liner 513 and, in some embodiments, comprise a folded portion of liner 513 .
现在参考保持器102，图27-28显示包括凹陷部108的保持器。凹陷部108可为任何合适的大小和形状。如图所示，凹陷部108大致成形为细长梯形。通过这种方式，凹陷部108的纵向渐缩壁可充当放置在保持器102内的医疗制品的一部分的邻接表面。短暂地转到图29，凹陷部108的近侧壁也可充当邻接表面。换句话讲，旋转螺母244的近侧表面可紧靠保持器102的远侧表面，以防止导管200在近侧方向上的移动。在一些实施方式中，保持器102被构造成将旋转螺母244悬置在患者的皮肤上方，以允许导管200相对于患者的皮肤以某一角度(例如，7度)插入到患者的皮肤中。Referring now to the retainer 102 , FIGS. 27-28 show the retainer including the recess 108 . Recess 108 may be of any suitable size and shape. As shown, the recess 108 is generally shaped as an elongated trapezoid. In this way, the longitudinally tapering walls of the recess 108 may serve as an abutment surface for a portion of a medical article placed within the holder 102 . Turning briefly to Fig. 29, the proximal wall of the recess 108 may also serve as an abutment surface. In other words, the proximal surface of the spin nut 244 can abut the distal surface of the retainer 102 to prevent movement of the catheter 200 in the proximal direction. In some embodiments, retainer 102 is configured to suspend rotating nut 244 above the patient's skin to allow catheter 200 to be inserted into the patient's skin at an angle (eg, 7 degrees) relative to the patient's skin.
返回到图27-28，凹陷部108的下表面的至少一部分可包括粘合剂。保持器102的其他表面也可包括粘合剂。例如，在一些实施方式中，形成凹陷部108的一个或多个壁包括粘合剂。保持器102的最上表面上也可包括粘合剂。该粘合剂可附着到放置在保持器102内的医疗制品200的一个或多个表面，以进一步限制医疗制品200的移动。Returning to Figures 27-28, at least a portion of the lower surface of the recess 108 may include an adhesive. Other surfaces of the holder 102 may also include adhesive. For example, in some embodiments, one or more walls forming the recess 108 include an adhesive. An adhesive may also be included on the uppermost surface of the holder 102 . The adhesive may be attached to one or more surfaces of the medical article 200 placed within the holder 102 to further restrict movement of the medical article 200 .
图30是图29的固定装置500的分解图。如图所示，保持器102可设置在折翼510的一部分上。然而，在一些实施方式中，保持器102设置在锚定垫104上。衬件514可设置在保持器102上方。如图所示，衬件514覆盖形成凹陷部108的向上延伸壁的上表面。在该实施方式中，保持器102的最上表面515包括可被可移除衬件514覆盖的粘合表面。FIG. 30 is an exploded view of the securing device 500 of FIG. 29 . As shown, retainer 102 may be disposed on a portion of flap 510 . However, in some embodiments, retainer 102 is disposed on anchor pad 104 . A liner 514 may be disposed over the retainer 102 . As shown, the liner 514 covers the upper surface of the upwardly extending wall forming the recess 108 . In this embodiment, the uppermost surface 515 of the retainer 102 includes an adhesive surface that may be covered by a removable liner 514 .
折翼510可包括可被可移除衬件513覆盖的粘合表面516。折翼510被构造成向下折叠、弯曲或旋转到保持器102上方。通过这种方式，当闭合时，处于闭合位置的折翼的下侧可附着到锚定垫和/或保持器和/或医疗制品上的一个或多个表面。折翼510可搁置在锚定垫104的一部分上。在一些实施方式中，折翼510结合到锚定垫104的至少一部分和/或保持器102的至少一部分。在一些实施方式中，锚定垫与折翼510相对的那一侧上的上表面的至少一部分包括粘合表面。通过这种方式，当将折翼折叠到保持器102上方时，锚定垫与折翼510相对的上表面上的粘合剂可进一步固定折翼510。Flap 510 may include an adhesive surface 516 that may be covered by a removable liner 513 . Flap 510 is configured to fold down, bend or rotate over holder 102 . In this way, when closed, the underside of the flaps in the closed position may adhere to the anchor pad and/or the retainer and/or one or more surfaces on the medical article. Flap 510 may rest on a portion of anchor pad 104 . In some embodiments, flap 510 is bonded to at least a portion of anchor pad 104 and/or at least a portion of retainer 102 . In some embodiments, at least a portion of the upper surface of the anchor pad on the side opposite the flap 510 includes an adhesive surface. In this way, the adhesive on the upper surface of the anchor pad opposite the flap 510 can further secure the flap 510 when the flap is folded over the holder 102 .
锚定垫104可包括下部粘合层106，使得在衬件520和521被移除时锚定垫104可固定到患者的皮肤。衬件514、520和521可与上文所述的衬件类似或相同。如图30所示，衬件520和521可包括铰接的两个部分。衬件520和521的至少一部分可被设定大小，以从锚定垫的周边延伸出来，形成拉舌525和526。Anchor pad 104 may include lower adhesive layer 106 such that anchor pad 104 may be secured to the patient's skin when liners 520 and 521 are removed. Liners 514, 520, and 521 may be similar or identical to the liners described above. As shown in Figure 30, liners 520 and 521 may comprise two parts that are hinged. At least a portion of liners 520 and 521 may be sized to extend from the perimeter of the anchor pads to form pull tabs 525 and 526 .
图31显示固定装置500的平面图。如图所示，保持器102中的凹陷部108为大致梯形形状，其在近端处的宽度比在远端处的宽度窄。通过这种方式，各种医疗装置和/或旋转螺母可至少部分地插入保持器102内，如上所述。在一些实施方式中，保持器从装置的远端大致伸展到近端的侧壁可用作邻接表面。因此，在介质制品放置在凹陷部108内时，这些侧壁可紧靠介质制品或其一部分的面朝近侧的侧面，以防止制品在至少近侧方向上的移动。FIG. 31 shows a plan view of the immobilization device 500 . As shown, the recess 108 in the retainer 102 is generally trapezoidal in shape with a narrower width at the proximal end than at the distal end. In this manner, various medical devices and/or swivel nuts may be at least partially inserted within retainer 102, as described above. In some embodiments, the sidewall of the retainer extending generally from the distal end to the proximal end of the device may serve as an abutment surface. Accordingly, when the media article is placed within the recess 108, the sidewalls may abut the proximally-facing side of the media article, or a portion thereof, to prevent movement of the article in at least the proximal direction.
在操作中，使用上文所述的固定装置500的方法以及用于将医疗制品连接到患者的过程可通过移除覆盖保持器102的最上表面的衬件514而开始，如图32所示。该过程可通过将医疗制品200放置在保持器102的凹陷部108内而继续。如图所示，医疗制品200包括旋转螺母202。固定装置的保持器102可被定位成使得旋转螺母244的至少一部分在保持器102上方。如图33所示，可向旋转螺母244施加向下压力，使得旋转螺母244可至少部分地移动到保持器102的凹陷部108中并且接触保持器102的至少一个粘合表面。In operation, the method of using the fixation device 500 described above and the process for attaching a medical article to a patient may begin by removing the liner 514 covering the uppermost surface of the retainer 102 , as shown in FIG. 32 . The process may continue by placing the medical article 200 within the recess 108 of the holder 102 . As shown, the medical article 200 includes a swivel nut 202 . The retainer 102 of the fixation device may be positioned such that at least a portion of the swivel nut 244 is above the retainer 102 . As shown in FIG. 33 , downward pressure may be applied to the spin nut 244 such that the spin nut 244 may move at least partially into the recess 108 of the retainer 102 and contact at least one adhesive surface of the retainer 102 .
该过程可通过移除覆盖锚定垫104的下部粘合表面106的衬件520和521而继续，如图34-36所示。通过这种方式，锚定垫104被固定到患者的皮肤。如图34所示，可通过抓住拉舌525并且将衬件520拉离锚定垫104的下表面来移除衬件520。因此，如图35所示，锚定垫的右手侧固定到患者的皮肤。类似地，如图36所示，可通过抓住拉舌526并且将衬件521拉离锚定垫104的左手侧的下表面来移除衬件521。如图36所示，使用者可能希望握住折翼510，使其远离锚定垫104，以便更好地触及拉舌526。在衬件520和521从锚定垫104的下部粘合表面106移除的情况下，将锚定垫104固定到患者的皮肤。The process may continue by removing the liners 520 and 521 covering the lower adhesive surface 106 of the anchor pad 104, as shown in FIGS. 34-36. In this way, anchor pad 104 is secured to the patient's skin. As shown in FIG. 34 , liner 520 may be removed by grasping tab 525 and pulling liner 520 away from the lower surface of anchor pad 104 . Thus, as shown in Figure 35, the right hand side of the anchor pad is secured to the patient's skin. Similarly, as shown in FIG. 36 , liner 521 may be removed by grasping tab 526 and pulling liner 521 away from the left-hand lower surface of anchor pad 104 . As shown in FIG. 36 , the user may wish to hold flap 510 away from anchor pad 104 for better access to pull tab 526 . With liners 520 and 521 removed from lower adhesive surface 106 of anchor pad 104, anchor pad 104 is secured to the patient's skin.
转到图37-38，可通过抓住拉舌512并且将衬件513拉离折翼510的顶部表面来移除折翼510的顶部表面上的衬件513。通过这种方式，暴露折翼510的顶侧上的粘合表面516。如图39-40所示，可将折翼510折叠到保持器102上方，使得折翼510的粘合表面516的一部分覆盖旋转螺母244和保持器102。折翼510还可与锚定垫104的一部分接触。通过这种方式，折翼510进一步将医疗制品固定到患者。图41显示固定装置500的顶视图，其中折翼510处于闭合位置中。Turning to FIGS. 37-38 , the liner 513 on the top surface of the flap 510 can be removed by grasping the pull tab 512 and pulling the liner 513 away from the top surface of the flap 510 . In this way, the adhesive surface 516 on the top side of the flap 510 is exposed. As shown in FIGS. 39-40 , flap 510 may be folded over retainer 102 such that a portion of adhesive surface 516 of flap 510 covers swivel nut 244 and retainer 102 . Flap 510 may also be in contact with a portion of anchor pad 104 . In this way, flaps 510 further secure the medical article to the patient. Figure 41 shows a top view of securing device 500 with flaps 510 in the closed position.
在一些实施方式中，将医疗制品固定到患者的过程可通过获得敷料400而继续，如图42所示。衬件可从敷料400的下表面移除，从而暴露敷料400的下侧面上的粘合表面。接着可将敷料400放置在插入部位上方并且借助敷料下侧上的合适的粘合表面将其附着到患者，如图42-43所示。该敷料可包括上述闭合层418。如图43所示，在一些实施方式中，可从闭合层418移除敷料的外周边499。在一些实施方式中，套件包括固定装置、敷料和/或胶带。该套件还可包括用于使用套件组件的说明。In some embodiments, the process of securing the medical article to the patient may continue by obtaining a dressing 400, as shown in FIG. 42 . The liner is removable from the lower surface of the dressing 400 , exposing the adhesive surface on the lower side of the dressing 400 . The dressing 400 can then be placed over the insertion site and attached to the patient with a suitable adhesive surface on the underside of the dressing, as shown in Figures 42-43. The dressing may include the occlusive layer 418 described above. As shown in FIG. 43 , in some embodiments, the outer perimeter 499 of the dressing can be removed from the occlusive layer 418 . In some embodiments, a kit includes an immobilization device, a dressing, and/or an adhesive tape. The kit may also include instructions for using the kit components.
现在转到图44-53，固定装置600的另一实施方式包括一体的敷料618、保持器102和锚定垫104。敷料618与锚定垫104成一整体和/或结合到锚定垫104，并且敷料618被构造成折叠到插入部位上方，如将在下文中进一步说明。如图所示，保持器102被具有拉舌616的衬件617覆盖。敷料618的面朝顶部的侧面被设置在敷料618的粘合表面上方的衬件625b覆盖。衬件625b包括形成拉舌625a的折叠部分。当衬件625b被移除时，可将可包括旋转螺母244的医疗制品200放置在保持器102内，如图46所示。保持器102可包括一个或多个粘合表面。Turning now to FIGS. 44-53 , another embodiment of a fixation device 600 includes an integral dressing 618 , retainer 102 and anchor pad 104 . The dressing 618 is integral with and/or bonded to the anchor pad 104 and is configured to be folded over the insertion site, as will be further described below. As shown, the retainer 102 is covered by a liner 617 having a pull tab 616 . The top-facing side of the dressing 618 is covered by a liner 625b disposed over the adhesive surface of the dressing 618 . Liner 625b includes a folded portion forming pull tab 625a. When liner 625b is removed, medical article 200 , which may include spin nut 244 , may be placed within holder 102 , as shown in FIG. 46 . Retainer 102 may include one or more adhesive surfaces.
如图所示，保持器102可包括凹陷部108。保持器102可设置在粘合剂层612上方，使得保持器102中的凹陷部108的底部表面包括粘合表面。粘合剂层612还可用来将保持器固定到锚定垫104。粘合剂层612可设置在锚定垫104上。粘合剂层614可设置在保持器102的最上表面上并且可被可移除衬件617覆盖。As shown, the retainer 102 may include a recess 108 . Retainer 102 may be disposed over adhesive layer 612 such that the bottom surface of recess 108 in retainer 102 includes an adhesive surface. Adhesive layer 612 may also be used to secure the retainer to anchor pad 104 . Adhesive layer 612 may be disposed on anchor pad 104 . An adhesive layer 614 may be disposed on the uppermost surface of the holder 102 and may be covered by a removable liner 617 .
转到敷料618，如图47所示，敷料618可包括粘合剂层622、垫623和闭合层418。如图47所示，粘合剂层622可设置在垫623的顶侧上，并且闭合层418可设置在垫623的下侧上。粘合剂层622可覆盖垫623的顶侧的全部或一部分。Turning to dressing 618 , as shown in FIG. 47 , dressing 618 may include adhesive layer 622 , pad 623 and occlusive layer 418 . As shown in FIG. 47 , adhesive layer 622 may be disposed on the top side of pad 623 and closure layer 418 may be disposed on the underside of pad 623 . Adhesive layer 622 may cover all or a portion of the top side of pad 623 .
敷料618可包括开口626，该开口被构造成使得医疗制品可在敷料618被折叠成覆盖插入部位和医疗制品时穿过开口626。敷料618还可包括槽636。槽636可被设定大小并被成形，使得医疗制品的一部分可穿过槽636。垫623可包括窗口632。窗口632可允许在不移除敷料618的情况下观察插入部位。粘合剂层620可被具有拉舌625a的衬件625b覆盖。如图所示，衬件625b具有与垫623大致相同的大小和形状，但不包括开口或槽。The dressing 618 may include an opening 626 configured such that the medical article may pass through the opening 626 when the dressing 618 is folded to cover the insertion site and the medical article. Dressing 618 may also include grooves 636 . The slot 636 can be sized and shaped such that a portion of the medical article can pass through the slot 636 . Pad 623 may include window 632 . Window 632 may allow viewing of the insertion site without removing dressing 618 . The adhesive layer 620 may be covered by a liner 625b having a pull tab 625a. As shown, liner 625b has approximately the same size and shape as pad 623, but does not include openings or slots.
在操作中，使用固定装置600的方法以及用于将医疗制品连接到患者的过程可通过如下操作而开始：旋转敷料618，使其远离锚定垫104，以展开固定装置600，如图44-45所示。使用者可接着抓住拉舌616并且从保持器移除衬件617(如图47所示)，因此暴露粘合剂层614，如图48中所示。In operation, the method of using the fixation device 600 and the process for attaching a medical article to a patient may begin by rotating the dressing 618 away from the anchor pad 104 to deploy the fixation device 600 as shown in Figure 44- 45. The user can then grasp the pull tab 616 and remove the liner 617 from the retainer (as shown in FIG. 47 ), thus exposing the adhesive layer 614 as shown in FIG. 48 .
该过程可通过如下操作而继续：移除覆盖锚定垫104的下部粘合表面的衬件608，如图49所示，因此暴露粘合剂层。该过程可通过如下操作而继续：将具有旋转螺母244的医疗制品200放置到保持器102的凹陷部108中，如图50所示，并且将锚定垫的粘合剂层放置在患者的皮肤上。因此，可将医疗制品200放置成接触保持器102的至少一个粘合表面，并且将固定装置固定到患者。转到图51，该过程可通过如下操作而继续：抓住敷料上的拉舌625a，并且通过将拉舌625a拉离敷料618来移除衬件625b。通过这种方式，暴露敷料618的粘合剂层622，如图52所示。如图53所示，接着可将敷料618折叠到锚定垫104、保持器102、医疗制品和插入部位的上方。通过这种方式，将敷料618固定到患者的皮肤。The process may continue by removing the liner 608 covering the lower adhesive surface of the anchor pad 104, as shown in Figure 49, thus exposing the adhesive layer. The process may continue by placing the medical article 200 with the spin nut 244 into the recess 108 of the holder 102, as shown in FIG. 50, and placing the adhesive layer of the anchor pad on the patient's skin superior. Thus, the medical article 200 can be placed in contact with at least one adhesive surface of the holder 102 and secure the fixation device to the patient. Turning to FIG. 51 , the process can continue by grasping the pull tab 625a on the dressing, and removing the liner 625b by pulling the tab 625a away from the dressing 618 . In this way, the adhesive layer 622 of the dressing 618 is exposed, as shown in FIG. 52 . As shown in FIG. 53, the dressing 618 may then be folded over the anchor pad 104, retainer 102, medical article, and insertion site. In this way, dressing 618 is secured to the patient's skin.
移到图54-68，固定装置700的另一实施方式包括折翼708、保持器102和锚定垫104。在某些实施方式中，折翼708为锚定垫104的一部分。锚定垫可包括折叠线789。在此类实施方式中，锚定垫折叠到保持器102上方的部分为折翼708。锚定垫的被折叠部分附接到锚定垫的另一部分。通过这种方式，锚定垫的第一部分附着到锚定垫的第二部分。Moving to FIGS. 54-68 , another embodiment of a fixation device 700 includes a flap 708 , a retainer 102 and an anchor pad 104 . In certain embodiments, the flap 708 is part of the anchor pad 104 . The anchor pads may include fold lines 789 . In such embodiments, the portion of the anchor pad that is folded over the retainer 102 is a flap 708 . The folded portion of the anchor pad is attached to another portion of the anchor pad. In this way, the first part of the anchor pad is attached to the second part of the anchor pad.
保持器102包括凹陷部108和一个或多个粘合表面。保持器102由锚定垫104支承。锚定垫104为大致矩形形状并且包括具有槽712的大致圆形开口710。槽712被构造成允许医疗制品的一部分穿过槽712并进入到锚定垫104的开口710中，如将在下文中所讨论的。锚定垫104的下表面106的至少一部分可包括粘合剂。Retainer 102 includes a recess 108 and one or more adhesive surfaces. Retainer 102 is supported by anchor pads 104 . The anchor pad 104 is generally rectangular in shape and includes a generally circular opening 710 with a slot 712 . The slot 712 is configured to allow a portion of the medical article to pass through the slot 712 and into the opening 710 of the anchor pad 104, as will be discussed below. At least a portion of the lower surface 106 of the anchor pad 104 may include an adhesive.
折翼708或锚定垫104的一部分被构造成移动、旋转和/或折叠到锚定垫104的另一部分的上方。折翼708包括窗口714。窗口714的大小和形状与锚定垫104中的开口710大致相同。折翼708中的窗口714可被透明膜或半透明膜覆盖。如图54-55所示，折翼708的顶侧可包括粘合表面744。保持器102的粘合表面、锚定垫104的粘合表面和/或折翼708的粘合表面可进一步被一个或多个衬件覆盖。例如，如图57所示，衬件799可覆盖保持器102的粘合表面716。如图56所示，可将具有旋转螺母244的医疗制品200放置在保持器102中的凹陷部108中。锚定垫104中的开口710大致围绕导管插入部位。可将折翼708折叠到锚定垫104上方，使得保持器102、锚定垫104和/或医疗制品200由折翼708接触。Flap 708 or a portion of anchor pad 104 is configured to move, rotate, and/or fold over another portion of anchor pad 104 . Flap 708 includes window 714 . The window 714 is approximately the same size and shape as the opening 710 in the anchor pad 104 . The window 714 in the flap 708 may be covered by a transparent or translucent film. As shown in FIGS. 54-55 , the top side of the flap 708 may include an adhesive surface 744 . The adhesive surface of the retainer 102, the adhesive surface of the anchor pad 104, and/or the adhesive surface of the flap 708 may further be covered by one or more liners. For example, as shown in FIG. 57 , liner 799 may cover adhesive surface 716 of retainer 102 . As shown in FIG. 56 , a medical article 200 with a spin nut 244 may be placed in the recess 108 in the holder 102 . The opening 710 in the anchor pad 104 generally surrounds the catheter insertion site. Flap 708 may be folded over anchor pad 104 such that retainer 102 , anchor pad 104 , and/or medical article 200 are contacted by flap 708 .
图57是固定装置700的分解图。粘合剂层716可设置在保持器102的顶部表面上。保持器102可设置在锚定垫104上。锚定垫的下侧上的粘合剂层可被可移除衬件726b和727b覆盖，所述衬件具有形成拉舌726a和727a的折覆部分(folder over sections)。折翼708包括设置在窗口714上方的膜718。粘合剂层744可设置在折翼708的顶侧上，使得当折翼708折叠到医疗制品上方时，粘合剂层744可附着到医疗制品，将折翼708固定在闭合位置中。粘合剂层744可被可移除衬件721b和722b覆盖，该衬件具有形成拉舌721a和722a的折覆部分。FIG. 57 is an exploded view of the securing device 700 . An adhesive layer 716 may be disposed on the top surface of the holder 102 . Retainer 102 may be disposed on anchor pad 104 . The adhesive layer on the underside of the anchor pads may be covered by removable liners 726b and 727b having folder over sections forming pull tabs 726a and 727a. Flap 708 includes a membrane 718 disposed over window 714 . Adhesive layer 744 can be disposed on the top side of flap 708 such that when flap 708 is folded over the medical article, adhesive layer 744 can adhere to the medical article, securing flap 708 in the closed position. Adhesive layer 744 may be covered by removable liners 721b and 722b having folded over portions forming pull tabs 721a and 722a.
在操作中，使用固定装置700的方法以及用于将医疗制品结合到患者的过程可通过从锚定垫104的下侧移除具有拉舌726a和727a的衬件726a和727b而开始，如图58-61所示。一般来讲，每个衬件覆盖锚定垫104的下侧的大约一半。在任何数量的配置中，可使用或多或少的衬件。如图59所示，移除左手侧衬件727b和拉舌727a(即，覆盖锚定垫104的槽侧的下侧的衬件)，从而暴露锚定垫104的下侧上的粘合剂层。In operation, the method of using securement device 700 and the process for bonding a medical article to a patient may begin by removing liners 726a and 727b with pull tabs 726a and 727a from the underside of anchor pad 104, as shown in FIG. 58-61. Generally, each liner covers about half of the underside of the anchor pad 104 . In any number of configurations, more or fewer liners may be used. As shown in FIG. 59, the left hand side liner 727b and pull tab 727a (i.e., the liner covering the underside of the groove side of the anchor pad 104) are removed, exposing the adhesive on the underside of the anchor pad 104 Floor.
该过程可通过如下操作而继续：定位固定装置700，使得医疗制品穿过槽712进入到锚定垫104的开口710中，如图60所示。固定装置700的保持器102可被定位成使得医疗制品的旋转螺母244定位在保持器102上方，并且接触保持器102的至少一个粘合表面。接着可从锚定垫104的下侧移除第二衬件726b和拉舌726a，如图61所示。因此，将固定装置700固定到患者的皮肤。如图62所示，在一些实施方式中，保持器102被构造成将旋转螺母244相对于患者的皮肤以某一角度(例如，7度)悬置在患者的皮肤上方。The process may continue by positioning the fixation device 700 such that the medical article passes through the slot 712 and into the opening 710 of the anchor pad 104, as shown in FIG. 60 . The holder 102 of the fixation device 700 can be positioned such that the swivel nut 244 of the medical article is positioned above the holder 102 and contacts at least one adhesive surface of the holder 102 . The second liner 726b and pull tab 726a may then be removed from the underside of the anchor pad 104, as shown in FIG. 61 . Thus, the fixation device 700 is secured to the patient's skin. As shown in FIG. 62, in some embodiments, the retainer 102 is configured to suspend the rotating nut 244 above the patient's skin at an angle (eg, 7 degrees) relative to the patient's skin.
该过程在图62-65中通过从折翼708移除衬件721b和722b以及拉舌721a和722a以暴露粘合表面744而继续。接着将折翼708折叠到锚定垫104、保持器102和医疗制品200的上方，如图66-68所示。通过这种方式，将医疗制品固定到患者的皮肤。The process continues in FIGS. 62-65 by removing liners 721b and 722b and pull tabs 721a and 722a from flap 708 to expose adhesive surface 744 . Flap 708 is then folded over anchor pad 104, retainer 102, and medical article 200, as shown in FIGS. 66-68. In this way, the medical article is secured to the patient's skin.
转到图69-79，固定装置700的另一实施方式包括保持器102和锚定垫104。保持器102的所示实施方式不包括如上所述的凹陷部，而是保持器102的顶部表面的至少一部分包括粘合剂808。保持器102被构造成以某一角度固定医疗制品。如图所示，顶部表面成角度θ。可使用多种不同的角度θ，该角度在从0度到45度或从5度到25度的范围内。例如，对于静脉内导管的固定，期望使导管与患者的皮肤的入射角为在约7度到约15度之间。对于动脉内导管的固定，期望使导管与患者的皮肤的入射角为约12.5度。通过使保持器102的顶部表面成所期望角度，该角度将取决于特定的固定应用(例如，固定动脉内导管、静脉内导管等)，可使导管维持恰当的入射角。Turning to FIGS. 69-79 , another embodiment of a fixation device 700 includes a retainer 102 and an anchor pad 104 . The illustrated embodiment of the holder 102 does not include a recess as described above, but instead at least a portion of the top surface of the holder 102 includes an adhesive 808 . Holder 102 is configured to hold the medical article at an angle. As shown, the top surface forms an angle θ. A variety of different angles Θ may be used, ranging from 0 degrees to 45 degrees or from 5 degrees to 25 degrees. For example, for the fixation of an intravenous catheter, it is desirable to have an incident angle of the catheter to the patient's skin of between about 7 degrees and about 15 degrees. For intra-arterial catheter fixation, it is desirable to have an incident angle of the catheter to the patient's skin of about 12.5 degrees. By angling the top surface of the holder 102 at a desired angle, which will depend on the particular fixation application (eg, securing an intra-arterial catheter, an intravenous catheter, etc.), the catheter can be maintained at the proper incident angle.
如图69-71所示，锚定垫104被成形为包括两个翼部分816和一个环部分850，其中，两个翼部分816被构造成支承保持器102，环部分850被构造成大致围绕医疗制品的插入部位并且构成膜812的框架。锚定垫104的下侧可包括粘合剂层106。As shown in FIGS. 69-71 , the anchor pad 104 is shaped to include two wing portions 816 configured to support the retainer 102 and a ring portion 850 configured to generally surround the The insertion site for the medical article and forms the frame of the membrane 812 . The underside of the anchor pad 104 may include an adhesive layer 106 .
如图71所示，可将具有旋转螺母244的医疗制品200放置在保持器102的顶部表面上。锚定垫104的环部分850大致围绕插入部位。锚定垫104的环部分850构成膜812的框架。锚定垫104还可包括槽814。槽814可被设定大小并被成形，使得医疗制品可穿过槽814。As shown in FIG. 71 , a medical article 200 with a spin nut 244 can be placed on the top surface of the holder 102 . The loop portion 850 of the anchor pad 104 generally surrounds the insertion site. The loop portion 850 of the anchor pad 104 forms the frame of the membrane 812 . The anchor pad 104 may also include a slot 814 . The slot 814 can be sized and shaped such that a medical article can pass through the slot 814 .
图72是固定装置800的分解图。双面胶带808可设置在保持器102的顶部表面上。保持器102可设置在锚定垫104上，位于锚定垫104的翼部分816的大致中心处。锚定垫104的下侧可被粘合剂层106覆盖。粘合剂层106的下侧的一部分可被膜810覆盖。在一些实施方式中，粘合剂层106的至少最外部分或外侧周边不被膜810覆盖。在一些实施方式中，膜810的下侧811包括粘合剂层。可移除衬件809可覆盖保持器102的粘合表面808。可移除衬件806、807和822可设置在锚定垫104和膜810的下侧上。可移除衬件806、807、809和/或822可包括形成拉舌的折叠部分，如上所述。FIG. 72 is an exploded view of the fixation device 800 . Double-sided tape 808 may be disposed on the top surface of holder 102 . Retainer 102 may be disposed on anchor pad 104 at approximately the center of wing portion 816 of anchor pad 104 . The underside of anchor pad 104 may be covered by adhesive layer 106 . A portion of the underside of adhesive layer 106 may be covered by film 810 . In some embodiments, at least an outermost portion or outer perimeter of adhesive layer 106 is not covered by film 810 . In some embodiments, the underside 811 of the film 810 includes an adhesive layer. A removable liner 809 may cover the adhesive surface 808 of the retainer 102 . Removable liners 806 , 807 , and 822 may be disposed on the underside of anchor pad 104 and membrane 810 . Removable liners 806, 807, 809, and/or 822 may include folded portions that form pull tabs, as described above.
在操作中，使用固定装置800的方法以及用于将医疗制品结合到患者的过程可通过如下操作而开始：将锚定垫104的环部分850远离锚定垫104的槽侧折叠，并且移除覆盖保持器102的顶部粘合表面的剥离衬件808，如图74所示。In operation, the method of using securement device 800 and the process for bonding a medical article to a patient may begin by folding loop portion 850 of anchor pad 104 away from the grooved side of anchor pad 104 and removing A release liner 808 covering the top adhesive surface of the holder 102 is shown in FIG. 74 .
该过程可通过如下操作而继续，对固定装置800进行定位，使得保持器102定位在医疗制品200的一部分的下方，如图75所示。如图76所示，该过程通过移除覆盖锚定垫104的翼部分816下侧的粘合表面的剥离衬件822而继续。接着，也可移除覆盖锚定垫104的环部分850的下表面的约一半的剥离衬件807。因此，将锚定垫104的环部分850的槽侧附着到患者的皮肤，如图77所示。移除覆盖锚定垫104下表面上的粘合剂层的其余部分和/或覆盖膜810的第二衬件806，如图78所示。接着将医疗制品固定到患者，如图79所示。The process may continue by positioning the fixation device 800 such that the retainer 102 is positioned below a portion of the medical article 200 as shown in FIG. 75 . As shown in FIG. 76 , the process continues by removing the release liner 822 covering the adhesive surface on the underside of the wing portion 816 of the anchor pad 104 . Next, release liner 807 covering approximately half of the lower surface of loop portion 850 of anchor pad 104 may also be removed. Thus, the groove side of the loop portion 850 of the anchor pad 104 is attached to the patient's skin, as shown in FIG. 77 . The second liner 806 covering the remainder of the adhesive layer on the lower surface of the anchor pad 104 and/or the cover film 810 is removed, as shown in FIG. 78 . The medical article is then secured to the patient, as shown in FIG. 79 .
本文所描述的固定装置可包括支承构件，用以支承医疗制品向保持器(例如保持器101)的远侧和/或保持器中的凹陷部(例如凹陷部108)的远侧延伸的部分。例如，某些导管可具有更长的长度或被附接到有利地由支承构件支承的延长管。支承构件可由任何适当的材料(例如，泡沫材料或塑料)制成，并且在一个实施方式中由与保持器(例如保持器101)相同的材料形成。支承构件可以是独立于固定装置的组件或者可以是与固定装置成一体，例如作为保持器的延伸部。支承构件可包括被构造成诸如通过摩擦配合(例如搭锁(snapping)在导管部分)而附接到向保持器的远侧延伸的导管部分或延长管部分的部分。支承构件可沿着折叠线或穿孔线而连接到固定装置(例如在保持器的远端处)，以便支承构件可连接到或脱离保持器。在一个实施方式中，支承构件可被连接到敷料。The fixation devices described herein may include a support member to support a portion of the medical article extending distally of a retainer (eg, retainer 101 ) and/or a recess in the retainer (eg, recess 108 ). For example, some catheters may have a longer length or be attached to extension tubes that are advantageously supported by support members. The support member may be made of any suitable material (eg, foam or plastic), and in one embodiment is formed of the same material as the retainer (eg, retainer 101 ). The support member may be a separate component from the fixation device or may be integral with the fixation device, for example as an extension of the holder. The support member may include a portion configured to attach to a catheter portion or extension tube portion extending distally of the retainer, such as by a friction fit (eg, snapping on the catheter portion). The support member may be attached to the fixation device (eg, at the distal end of the retainer) along a fold line or perforation line such that the support member may be attached to or detached from the retainer. In one embodiment, the support member may be attached to the dressing.
图80图示了支承构件900的一个实施方式。支承构件900具有前表面902、后表面904和从顶表面906延伸出的通道908。支承构件900具有厚度910。图81图示了与固定装置一起使用中的支承构件900的一个例子，其中固定装置包括保持器101。导管290由固定装置支承并且包括处于通道108中的部分。导管部分292和294延伸超出通道108，并且导管部分294由支承构件900支承。在图81中，导管部分294被显示搁置在通道908中但是未完全处于通道908内，并且支承构件900定位在保持器101的远侧抵靠保持器101的后部分。支承构件900可以是单独的组件、未附接到保持器101的后表面或以某些方式附接到保持器101的后表面(例如，通过粘合剂)、或者可以作为保持器101的延伸部与保持器101成一体。图82图示了从保持器101的顶表面延伸出的支承构件900的一个例子。再次，支承构件900可以是单独的组件、未附接到保持器101的后表面或以某些方式附接到保持器101的后表面(例如，通过粘合剂)、或者可以与保持器101成一体。在一个实施方式中，图81中的支承构件900可以沿着折叠线远离保持器的顶表面进行折叠并同时保持连接到保持器的顶表面。在图81的实施方式中，导管部分294被显示完全处于通道908内，例如以摩擦配合布置的方式，使得导管290可拆卸地锁定到支承构件900。FIG. 80 illustrates one embodiment of a support member 900 . Support member 900 has a front surface 902 , a rear surface 904 and a channel 908 extending from a top surface 906 . The support member 900 has a thickness 910 . FIG. 81 illustrates an example of a support member 900 in use with a fixation device comprising a retainer 101 . Conduit 290 is supported by the fixture and includes a portion within channel 108 . Conduit portions 292 and 294 extend beyond channel 108 , and conduit portion 294 is supported by support member 900 . In FIG. 81 , catheter portion 294 is shown resting in channel 908 but not completely within channel 908 , and support member 900 is positioned distally of retainer 101 against the rear portion of retainer 101 . The support member 900 may be a separate component, not attached to the rear surface of the holder 101 or attached in some way to the rear surface of the holder 101 (eg, by adhesive), or may be an extension of the holder 101 The part is integrated with the holder 101. FIG. 82 illustrates an example of a support member 900 extending from the top surface of the holder 101 . Again, the support member 900 can be a separate component, not attached to the back surface of the holder 101 or attached in some way to the back surface of the holder 101 (e.g., by an adhesive), or can be attached to the holder 101 into one. In one embodiment, the support member 900 in FIG. 81 can be folded along the fold line away from the top surface of the holder while remaining attached to the top surface of the holder. In the embodiment of FIG. 81 , conduit portion 294 is shown fully within channel 908 , such as in a friction fit arrangement such that conduit 290 is releasably locked to support member 900 .
图83图示了支承构件910的一个实施方式。支承构件910具有前表面912、后表面914和侧表面916。支承构件910被显示形成为特定的棱柱形状，但是还可以考虑其它几何形状，例如矩形棱柱、三角形棱柱、六边形棱柱、圆柱等。图84-85图示了与固定装置的保持器101相关的支承构件910的不同视图。导管部分292显示搁置在支承构件910表面之间的边缘上。支承构件910可以是单独的组件、未附接到保持器101的后表面或以某些方式附接到保持器101的后表面(例如，通过粘合剂)、或者可以作为保持器101的延伸部与保持器101成一体。在图84-85中，显示支承构件910沿着折叠线920附接到保持器101，这允许支承构件910从非使用位置(未示出)折叠到使用位置，在使用位置中，支承构件相对于保持器101成一定的角度。在一个实施方式中，折叠线920被穿孔以便于支承构件910与保持器分离。尽管图81-82和84-85中显示支承构件900和910结合到保持器，但还可考虑的是，支承构件可结合到固定装置的其它方面，诸如例如锚定垫或敷料。FIG. 83 illustrates one embodiment of a support member 910 . The support member 910 has a front surface 912 , a rear surface 914 and side surfaces 916 . The support member 910 is shown formed as a particular prismatic shape, but other geometric shapes such as rectangular prisms, triangular prisms, hexagonal prisms, cylinders, etc. are also contemplated. 84-85 illustrate different views of the support member 910 in relation to the holder 101 of the fixation device. Conduit portion 292 is shown resting on an edge between support member 910 surfaces. The support member 910 may be a separate component, unattached or attached in some way to the rear surface of the holder 101 (eg, by adhesive), or may be an extension of the holder 101 The part is integrated with the holder 101. In FIGS. 84-85 , support member 910 is shown attached to holder 101 along fold line 920 , which allows support member 910 to be folded from a non-use position (not shown) to a use position in which the support members face each other. form a certain angle with the holder 101. In one embodiment, fold line 920 is perforated to facilitate separation of support member 910 from the retainer. Although the support members 900 and 910 are shown coupled to the retainer in FIGS. 81-82 and 84-85, it is also contemplated that the support members may be coupled to other aspects of the fixation device, such as, for example, anchor pads or dressings.
应当注意的是，本文中所提供的附图未按任何特定比例或尺度绘制，并且可对所示实施例做出许多变型。本领域技术人员将认识到，本文所示的本发明所公开的方面和特征并不限于稳定系统的任何特定实施方式，并且包括本文所述特征中的一者或多者的稳定系统可被设计成与多种医疗制品一起使用。It should be noted that the drawings provided herein are not drawn to any particular scale or scale and that many variations may be made to the illustrated embodiments. Those skilled in the art will appreciate that the disclosed aspects and features of the invention shown herein are not limited to any particular implementation of a stabilization system and that stabilization systems including one or more of the features described herein may be designed Intended to be used with a variety of medical products.
上文根据本发明所述的固定装置和系统的各种实施方式因此提供将医疗制品固定到患者的装置。可用敷料覆盖附接到连接器配件或延长套件的导管的插入部位。The various embodiments of the above described securing devices and systems according to the present invention thus provide means for securing a medical article to a patient. The insertion site of the catheter attached to the connector fitting or extension set may be covered with a dressing.
当然，应当理解的是，根据本发明的任何特定实施方式，未必可实现所有的目标或优点。因此，例如，本领域技术人员将认识到，可按照如下方式来实施或执行本发明：实现或优化如本文所教导的一个优点或一组优点，而不一定非要实现本文可能教导或暗示的其他目标或优点。Of course, it is to be understood that not all objectives or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the present invention may be practiced or carried out in a manner that achieves or optimizes an advantage or group of advantages as taught herein without necessarily achieving what may be taught or implied herein Other goals or benefits.
此外，技术人员将认识到来自不同实施方式的各种特征的可互换性。例如，可在实施方式之间交换在各种实施方式中所公开的保持器的特征。除本文所述的变型以外，本领域普通技术人员还可混合并且匹配每一特征的其他已知等效形式，以根据本发明的原理构造稳定系统和技术。Furthermore, the skilled artisan will recognize the interchangeability of various features from different embodiments. For example, features of retainers disclosed in various embodiments may be exchanged between embodiments. In addition to the variations described herein, one of ordinary skill in the art can also mix and match other known equivalents for each feature to construct stabilization systems and techniques in accordance with the principles of the invention.
虽然已在某些实施方式和实施例的背景中公开了本发明，但本领域技术人员可以理解，本发明超出具体公开的实施方式而扩展到本发明的其他替代实施方式和/或用途，以及本发明的各种显而易见的修改和等效形式。因此，预期使本文所公开的本发明的范围不应受到上文所述的特定公开实施方式的限制。Although the invention has been disclosed in the context of certain embodiments and examples, it will be appreciated by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention, and Various obvious modifications and equivalents of the invention. Therefore, it is intended that the scope of the present invention disclosed herein should not be limited by the particular disclosed embodiments described above.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910923427.1ACN110639115B (en) | 2013-09-06 | 2014-09-05 | Medical article securement systems |
| Application Number | Priority Date | Filing Date | Title |
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| USPCT/US2013/058606 | 2013-09-06 | ||
| PCT/US2013/058606WO2014039891A2 (en) | 2012-09-07 | 2013-09-06 | Medical article securement systems |
| PCT/US2014/054395WO2015035238A1 (en) | 2013-09-06 | 2014-09-05 | Medical article securement systems |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910923427.1ADivisionCN110639115B (en) | 2013-09-06 | 2014-09-05 | Medical article securement systems |
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| CN105530978A CN105530978A (en) | 2016-04-27 |
| CN105530978Btrue CN105530978B (en) | 2019-11-01 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201480048406.5AActiveCN105530978B (en) | 2013-09-06 | 2014-09-05 | Medical product fixation system |
| CN201910923427.1AActiveCN110639115B (en) | 2013-09-06 | 2014-09-05 | Medical article securement systems |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910923427.1AActiveCN110639115B (en) | 2013-09-06 | 2014-09-05 | Medical article securement systems |
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| EP (1) | EP3041552A4 (en) |
| CN (2) | CN105530978B (en) |
| WO (1) | WO2015035238A1 (en) |
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| CN105530978A (en) | 2016-04-27 |
| WO2015035238A1 (en) | 2015-03-12 |
| CN110639115B (en) | 2022-06-21 |
| EP3041552A4 (en) | 2017-05-10 |
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| JP7496384B2 (en) | Medical Article Securing System | |
| CN105530978B (en) | Medical product fixation system | |
| JP6749976B2 (en) | Fastening device with integrated strap and dressing |
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |