• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Attachment attachment for a tracheal stoma assembly comprising the tracheal stoma assembly a fixation bracket configured to be fixed in a location close to the tracheal stoma and a device for tracheal stoma in fluid connection with the tracheal stoma and configured to be linked with the tracheal support. fastening, wherein the fastening accessory comprises fixing means to the user; and anchoring means configured to engage the fixation support of the tracheal stoma assembly and the attachment means to the user's body; and additionally configured to house the device for tracheal stoma. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2717690A1
    申请号:ES201731457
    申请日:2017-12-22
    公开日:2019-06-24
    发明作者:Lopez Alejandro Ruiz
    申请人:3d Zings Additive Tech S L；
    IPC主号:
    专利说明:

    [0001]
    [0002]
    [0003]
    [0004] The present invention is related to the field of medical devices, in particular with a support for a device that engages in the stoma of a trachea, after a tracheotomy procedure. More particularly, the present invention relates to a support that assists in securing devices that are usually fixed in an adhesive manner around a tracheal stoma, making the integrity of the adhesive bond last longer.
    [0005]
    [0006]
    [0007]
    [0008] When there are failures in the airways of a person that prevent him from getting enough air due to injuries, disorders or affectations of the nervous or respiratory systems, in order to restore the airway and allow its proper function a surgical procedure is performed called a tracheotomy that consists of creating an opening, known as a stoma, inside the trachea through an incision made in the neck and inserting a tube or cannula with an inflatable cuff that occludes the space between the walls of the trachea and the cannula, to facilitate the passage of air into the lungs. The tracheotomy provides an artificial airway, however, because of it, the air no longer passes through the upper trachea and oropharynx unless the cannula is sleeveless, the cuff is deflated or a speech valve is used. The lack of air flow through the upper respiratory tract reduces tone and pharyngeal and laryngeal sensation and prevents effective glottal closure, minimizing or canceling speech ability.
    [0009]
    [0010] As a consequence of the tracheotomy procedure, the inhaled and exhaled air can pass through the tracheal stoma and, if a voice prosthesis has been placed, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis to the pharynx and mouth, allowing the person to speak. It is desirable that the flow of exhaled air is controlled by a valve located in the tracheal stoma. In these cases, the valve can be arranged to remain open during breathing, but it can be closed to divert air flow, through a small additional increase in exhaled air flow.
    [0011] Multiple devices have been developed to fit into the tracheal stoma such as filters, tracheal humidifiers, respiratory protectors and talking valves, to provide users with alternative ways to recover some of the removed functions when air does not pass through the nose, Among which stands out to restore the ability to speak. Such devices are used together with a support that hold them in place, so they can be called a joint for tracheal stoma, where said support is arranged above the tracheal stoma of the person, and can be fixed to the skin by an adhesive band, where the adhesive is oriented towards the user's skin.
    [0012]
    [0013] A widely known problem that is related to the fixation of the support for the tracheal stoma device is the limited duration of the adhesive effect of said support on the skin due to factors such as skin irregularity, sweat, deformations of the area , sinking of the tracheal stoma, the pressure of the air flow leaving the stoma, among others. This limited adhesion effect causes the support to detach much earlier than expected, whereby the tracheal stoma device, such as a speech valve, stops functioning properly, and the assembly loses its location with respect to the tracheal stoma, having in many cases the user to intervene holding the support to prevent it from coming off even more prematurely. This recurring problem leads to users ending up discarding or minimally using devices for tracheal stoma.
    [0014]
    [0015] Currently, some solutions are offered to increase the duration of adhesion of the support on the skin through products such as special glues that, in addition to being expensive, can irritate and affect the skin around the stoma, without actually solving the problem. described
    [0016]
    [0017] Therefore, it is evident the need to provide an accessory that helps in the attachment of the tracheal stoma assembly, where said accessory increases the time it remains fixed with respect to the tracheal stoma.
    [0018]
    [0019]
    [0020]
    [0021] To overcome the inconvenience found, the present invention provides a fastening accessory for a tracheal stoma assembly comprising the tracheal stoma assembly a fixation support configured to be fixed in a place close to the tracheal stoma and a device for tracheal stoma in fluid connection with the tracheal stoma and configured to link with the fixation support, where the fastening accessory comprises user fixing means; and anchoring means configured to engage the fixation support of the tracheal stoma assembly and the attachment means to the user's body; and additionally configured to house the device for tracheal stoma.
    [0022]
    [0023] In alternative embodiments of the fastening accessory for a tracheal stoma assembly, the means for attaching to the body of the user comprise a set of straps intended to be attached to the user's torso.
    [0024]
    [0025] In other alternative embodiments of the attachment attachment for a stoma assembly the anchoring means comprise an elastic plate configured to engage the fixation support of the tracheal stoma assembly; and an anchor plate configured to engage the elastic plate and which is provided with fastening means configured to couple the belt assembly to said anchor plate.
    [0026]
    [0027] The main advantage achieved with the fastening accessory of the present invention is that, by externally securing the fixing support, a support is provided to the adhesive bond between said fixing support and the user's skin, thus maintaining its integrity during more time, so the tracheal stoma assembly prolongs its functional position without requiring user attention.
    [0028]
    [0029]
    [0030]
    [0031] The foregoing and other advantages and features will be more fully understood from the following detailed description of some embodiments with reference to the attached drawings, which should be considered by way of illustration and not limitation, in which:
    [0032]
    [0033] - Fig. 1 is a perspective view of a preferred embodiment of the invention in which the attachment is arranged in a user.
    [0034] - Fig. 2 is a perspective view of a common tracheal stoma assembly, the assembly comprising a fixation support and a tracheal stoma device. - Fig. 3 is a perspective view of the fixing accessory of a preferred embodiment, in which the user has been omitted but the tracheal stoma assembly has been left visible.
    [0035] - Fig. 4 is an exploded perspective view of the anchoring means, in which the assembly for tracheal stoma is visible
    [0036]
    [0037]
    [0038]
    [0039] In the following detailed description numerous specific details are set forth in the form of examples to provide a thorough understanding of the relevant teachings. However, it will be apparent to those skilled in the art that the present teachings can be implemented without such details.
    [0040]
    [0041] According to a first embodiment, and as can be seen in Figure 1, the invention reveals a clamping accessory (1) for a tracheal stoma assembly (2) comprising the tracheal stoma assembly (2) a fixation support (3) ) configured to be fixed in a place close to a tracheal stoma (ET) and a device for tracheal stoma (4) in fluid connection with the tracheal stoma (ET) and configured to link with the fixation support (3), where the accessory of fastening (1) comprises user fixing means (5) and anchoring means (6) configured to engage the fixing support (3) of the tracheal stoma assembly (2) and the user fixing means (5) ), where the anchoring means (6) are additionally configured to house the device for tracheal stoma (4).
    [0042]
    [0043] Fixing brackets (3) are widely known in the field of medical devices used when tracheotomy procedures have been performed. As seen in Figure 2, in a typical tracheal stoma assembly (2) the fixation brackets (3) are designed to be secured by an adhesive bond to the user's skin and generally comprise a base plate (3A) which is provided with a hole (3B) that crosses said base plate (3A). The base (3A) comprises an adhesive side (3A ') that is oriented towards the user and is configured to adhere to the user's skin, and an outer side (3A'') that is oriented towards the outside. Enclosing the hole (3B) and fixed to the base (3A) a tubular coupling (3C) is arranged to fix the device for tracheal stoma (4), where said tubular coupling (3C) is a tubular type coupling such as a sleeve or a hollow cylindrical body. When the fixing support (3) is arranged in the user, the base plate (3A) must be fixed in such a way that the hole (3B) aligns with the tracheal stoma (ET) to establish a fluid communication between the tubular coupling ( 3C) and said tracheal stoma (ET). Likewise, the adhesive fixation of the base plate (3A) with the skin must be such that the inspired and exhaled air only has the tubular coupling (3C) of the fixing support (3) as a flow path. The coupling (3C) It generally comprises fixation means (not shown) configured to fix the device for tracheal stoma (4). Such fixing means may comprise an annular recess (not shown) in the inner wall of the tubular coupling (3C). This recess is configured to couple an annular shoulder (not shown) defined in a connection portion (4A) of the tracheal stoma device (4). Alternatively, the wall inside the tubular coupling (3C) may be provided with an annular shoulder (not shown) configured to engage with an annular recess (not shown) defined in the connection portion (4A) of the tracheal stoma device ( 4). Since the fixing brackets (3) and the devices for tracheal stoma (4) are devices on which the present invention is applied, the particular configuration of said devices is not relevant as long as the following conditions are met: the base ( 3A) must be adhesively fixed on the user with the tubular coupling (3C) aligned and in fluid communication with the tracheal stoma (ET) and the tracheal stoma device (4) releasably coupled to said tubular coupling (3C) .
    [0044]
    [0045] On the other hand, the device for tracheal stoma (4) intended to be attached to the fixation support (3) can be one of a filter, a trachea humidifier, a respiratory protector, a talking valve, etc. In the preferred embodiment the device for tracheal stoma (4) comprises a speaking valve.
    [0046]
    [0047] As can be seen in Figure 4, the user fixing means (5) of the fastening accessory (1) comprise a set of belts intended to be attached to the user's chest. Said belt assembly is constituted by a thorax fastening strap (5A) intended to surround and adjust to the user's chest, a right shoulder strap (5B), a left shoulder strap (5C), a right front strap (5D ) and a left front brace (5E), wherein said braces each comprise a first end configured to be attached to the chest strap (5A) and a second end configured to engage the anchoring means (6), being configured each of the braces (5B to 5E) configured to fit the user's chest. Preferably at each of said second ends a connector (51) is provided configured to be fixed in the anchoring means (6) of the clamping accessory (1). As seen in better detail in Figure 4, the connector (51) which in turn comprises a first portion (51A) configured to be attached to the tie rod and a protruding portion (51B) which, as will be seen later, is configured to be coupled to an anchor plate (8) of the anchoring means (6). To provide a feeling of comfort to the user, the set of belts are elastic type belts composed of textile materials, for example, a first elastic internal material that is covered by a second elastic and resistant outer material, such elastic materials being able to be selected Starting from neoprene, among others. Likewise, each of the straps (5B, 5C, 5D, 5E) as well as the chest strap (5A) are provided with length adjustment means configured to adjust the belt assembly to the user's body dimensions. In the case of the braces (5B, 5C, 5D, 5E) the length adjustment means are carried out in the same way that the braces of a female bra are regulated, which is widely known, while for the strap It is possible to use a means of graduation similar to that of the braces or a unitary elastic strap that expands to fit the thorax dimension. Other ways of adjusting the length of the belt assembly can be employed without departing from the scope of the invention.
    [0048]
    [0049] On the other hand, and as can be seen in Figure 4, the anchoring means (6) comprises an elastic plate (7) configured to engage the fixing support (3) of the tracheal stoma assembly (2), and a plate of anchor (8) configured to engage the elastic plate (7) and which is provided with fastening means (9) configured to attach the belt assembly (5) to said anchor plate (8). The elastic plate (7) comprises a through hole (7A) configured to receive the tubular coupling (3C), and an inner face (7B) configured to rest on the support bracket (3) and an outer face (7C) configured to lean on the anchor plate (8) according to what has been observed in figure 4. On the inside wall of the through hole (7A) a projection (7A ') is defined, which, as will be seen in subsequent lines, is configured to engage with a recess (8B ') defined in a tubular portion (8B) of the anchor plate (8). The elastic plate (7) has as its main function to serve as a damping element between the anchor plate (8) and the fixing support (3) to ensure that the support given to said fixing support (3) is of the elastic type , so that the user of the fixing accessory (1) can move freely, without fear that the different body positions can create additional efforts in the fixing support (3) through the anchor plate (8). Given the nature of the movements that a person can perform during a day, it is possible that some positions cause unexpected efforts or loads on the anchor plate (8) through the braces (5B, 5C, 5D, 5E), so which the elastic plate (7) has been configured to absorb all these possible deformations maintaining a uniform clamping pressure of the anchor plate (8) on the fixing support (3) to thus prolong the integrity of the adhesive seal of the support fixing (3) with the user's skin. Thus, the fixation accessory (1) of the present invention provides an integral support to the tracheal stoma assembly (2) formed by the fixation support (3) and the tracheal stoma device (4). The material for the elastic plate (7) can be chosen from several different classes of polymers as long as they meet the requirements of low hardness, dimensional stability and deformation absorption.
    [0050] An example of the material from which the plate can be manufactured is Dow Corning® EE-3200 polymer from Dow Corning Corporation. This should not be taken as limiting but a simple application of the material from which the plate can be manufactured, taking into account that other materials are also applicable without departing from the scope of the invention.
    [0051]
    [0052] In preferred embodiments, the elastic plate (7) is configured as a circular plate, the through hole (7A) being a circular through hole, where the shoulder (7A ’) is an annular shoulder.
    [0053]
    [0054] As seen in Figures 4 and 5, the anchor plate (8) comprises an outer plate (8A) and a tubular portion (8B) extending from the outer plate (8A), where the outer dimension of said tubular portion (8B) is configured to fit tightly in the through hole (7A) of the elastic plate (7). Also, in said tubular portion (8B) a recess (8B ’) is defined configured to receive the projection (7A’) of the through hole (7A) of the elastic plate (7). In preferred embodiments, the outer plate (8A) is a circular plate and the tubular portion (8B) is a cylindrical sleeve, where the recess (8B ’) is an annular recess. On the other hand, the outer plate (8A) comprises an inner face (8A ') from which the tubular portion (8B) is projected and on which the outer face (7C) of the elastic plate (7) rests, and an outer face (8A '') in which fixing means configured to fix the strips (5B, 5C, 5D, 5E) of the belt assembly are provided. Preferably said fixing means comprise holes (8C) distributed on the outer face (8A '') configured to couple the projecting portion (51B) of the connector (51) disposed in each of the strips (5B, 5C, 5D, 5E) . In the preferred embodiment shown in Figures 4 and 5, the fixing means comprise at least 4 holes (8C). Likewise, the anchor plate comprises a through hole (8D) configured to house the device for tracheal stoma (4) and allow said device (4) to engage in the fixing support (3). The material from which the anchor plate (8) is made is preferably selected from a rigid polymer of high mechanical strength with good dimensional stability, such as, for example, PA 2200 polymer from EOS GmbH. This should not be taken as limiting, since other materials can be applied without departing from the scope of the invention.
    权利要求:
    Claims (3)
    [1]
    1. Clamping accessory (1) for a tracheal stoma assembly (2) comprising the tracheal stoma assembly a fixation support (3) configured to be fixed in a place close to the tracheal stoma (ET) and a tracheal stoma device ( 4) in fluid connection with the tracheal stoma (ET) and configured to link with the fixation support (3), the attachment accessory (1) being characterized in that it comprises:
    - means for fixing the user (5); Y
    - anchoring means (6) configured to be attached to the fixation support (3) of the tracheal stoma assembly (2) and to the user fixing means (5); and additionally configured to house the device for tracheal stoma (4).
    [2]
    2. Clamping accessory (1) for a tracheal stoma assembly (2) according to claim 1 wherein the user fixation means (5) are characterized in that they comprise:
    - a set of belts intended to be attached to the user's chest.
    [3]
    3. Clamping accessory (1) for a tracheal stoma assembly (2) according to claim 2 wherein the anchoring means (6) are characterized in that they comprise:
    - an elastic plate (7) configured to engage the fixing support (3) of the tracheal stoma assembly (2); Y
    - An anchor plate (8) configured to engage the elastic plate (7) and which is provided with fixing means configured to couple the belt assembly to said anchor plate.
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    同族专利:
    公开号 | 公开日
    ES2717690B2|2020-02-24|
    EP3501585A1|2019-06-26|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    GB1212904A|1968-04-16|1970-11-18|Arthur Richardson|Improvements in or relating to colostomy, ileostomy and cecostomy appliances|
    US4489723A|1981-05-28|1984-12-25|Elliot Simons|Swimming apparatus|
    US5022394A|1988-10-11|1991-06-11|Homecare Of Dearborn|Heat and moisture exchanger device for tracheostomy patients|
    JP2008245988A|2007-03-30|2008-10-16|Shiro Hinami|Tube fixing device|
    WO2013032334A1|2011-09-01|2013-03-07|Stichting Katholieke Universiteit|Automatic tracheostoma speech valve fixation brace|
    JP2016137109A|2015-01-28|2016-08-04|学校法人北里研究所|Cannula holding band|
    WO2016179274A1|2015-05-04|2016-11-10|Mdrs, Llc|Tracheal tube apparatus and methods|
    US4574798A|1983-12-12|1986-03-11|Heitzman William G|Surgical appliance support|
    DE202010001806U1|2010-02-04|2010-05-20|Neubauer, Norbert|Shower protection for tracheostoma|
    DE202010004455U1|2010-04-01|2010-06-17|Neubauer, Norbert|tracheostomy|
    US20150096557A1|2014-02-05|2015-04-09|The Robert H. Bauer Revocable Trust|Laryngectomee snorkel|
    DE202015007696U1|2015-11-07|2016-01-14|Norbert Neubauer|Tracheostoma patches with clamping element|
    法律状态:
    2018-12-18| PC2A| Transfer of patent|Owner name: RAFAEL FUENTES BERNAL Effective date: 20181212 |
    2019-06-24| BA2A| Patent application published|Ref document number: 2717690 Country of ref document: ES Kind code of ref document: A1 Effective date: 20190624 |
    2020-02-24| FG2A| Definitive protection|Ref document number: 2717690 Country of ref document: ES Kind code of ref document: B2 Effective date: 20200224 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201731457A|ES2717690B2|2017-12-22|2017-12-22|CLAMPING ACCESSORY FOR A TRAQUEAL STOMA ASSEMBLY|ES201731457A| ES2717690B2|2017-12-22|2017-12-22|CLAMPING ACCESSORY FOR A TRAQUEAL STOMA ASSEMBLY|
    EP18382918.3A| EP3501585A1|2017-12-22|2018-12-12|Securing accessory for an assembly for tracheal stoma|
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