Tracheostomy seal device

Abstract

A tracheostomy sealing device is provided, comprising: an inner sealing member for insertion through a tracheostomy of a patient, the inner sealing member being configured to seal an inner opening of the tracheostomy; and an outer anchor for placement on an outer side of the tracheostomy, wherein the outer anchor is configured to exert a pulling force on the inner sealing member so as to hold the inner sealing member against the inner opening of the tracheostomy, thereby sealing the inner opening, and wherein the tracheostomy sealing device is configured such that the pulling force increases with increasing distance between the inner sealing member and the outer anchor.

Description

Technical Field

[0001] This disclosure generally relates to a tracheostomy sealing device comprising an internal sealing member and an external anchor, and more specifically, to a tracheostomy sealing device comprising an internal sealing member and an external anchor, wherein the external anchor applies a tensile force to the internal sealing member such that the tensile force increases with the distance between the internal sealing member and the external anchor. Background Technology

[0002] A tracheostomy tube is a short, curved tube that is inserted through a surgical opening in the patient's neck and secured in place around the neck with a tracheostomy band. The purpose of a tracheostomy tube is to provide a patient with an airway or to facilitate the suctioning of secretions from the airway.

[0003] There are various reasons why a patient needs a tracheostomy tube. Once the reason for the tracheostomy tube's placement has been resolved, it is usually removed. This procedure is called extubation. After extubation, a hole is left in the patient's neck, called a stoma. In most patients, the stoma will close spontaneously after extubation. This usually happens within two to three weeks. For patients whose stomas do not close spontaneously, surgical closure of the stoma is required.

[0004] Currently, when a patient is extubated, a choking or gauze-bandage-only dressing is placed on the patient, which remains in place for several days after extubation. When the patient leaves the hospital, and in some cases even within the hospital, such as when transferring from the intensive care unit to a regular care ward, the common method of covering the stoma is with a bandage. The patient is then instructed to cover the stoma with their fingers when they need to speak or cough.

[0005] This method of covering the stoma with a bandage and using a finger to block it in order to speak has several drawbacks. First, patients may not actually be able to block the stoma with their fingers as needed. Second, in all patients, without some form of airtight covering, the air entering and leaving the stoma when the patient attempts to speak can cause difficulty (or even make it impossible) in speaking. Third, if only a bandage is used, air will be forced out of the stoma when the patient coughs, even when the stoma is uncovered, and air may enter and leave the stoma even during normal breathing. This movement of air through the stoma reduces the likelihood of it closing spontaneously without surgery. Fourth, touching the stoma with the patient's fingers to speak or cough greatly increases the patient's chances of stoma and airway infection and can lead to contamination and the spread of infection. Fifth, in existing products, the pressure on the stoma is not constant, and air leaks out when speaking and coughing, thus preventing the patient from coughing effectively. There is also a risk of atelectasis (collapse or closure of alveoli), which may result from a lack of pressure after exhalation and can affect part or all of the lungs, leading to inadequate ventilation and reduced or no gas exchange. Atelectasis is often associated with mucus buildup and, in some cases, can lead to pneumonia.

[0006] Existing products may be designed to address any / all of the above problems by providing a sealing device to seal the stoma. In some existing products, a sealing element is placed inside the patient's neck to seal the internal opening of the stoma, and an external element rests on the patient's skin to anchor the sealing element in place (e.g., using a suture).

[0007] However, the sealing element placed inside the patient's neck is potentially prone to dislodgement (e.g., when the patient moves), which may reduce the seal of the stoma.

[0008] Therefore, it is desirable to provide an improved device for sealing stomas that is less likely to detach. Furthermore, other desirable features and characteristics of this disclosure will become apparent from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical and background information. Summary of the Invention

[0009] In one aspect, a tracheostomy sealing device is provided, comprising: an internal sealing member for insertion through a patient's tracheostomy, the internal sealing member being configured to seal an internal opening of the tracheostomy; and an external anchor for placement on the outside of the tracheostomy, wherein the external anchor is configured to apply a tensile force to the internal sealing member to hold the internal sealing member against the internal opening of the tracheostomy, thereby sealing the internal opening, and wherein the tracheostomy sealing device is configured such that the tensile force increases with increasing distance between the internal sealing member and the external anchor.

[0010] In one embodiment, the tracheostomy sealing device is configured such that the tensile force increases linearly with the increase of the distance between the internal sealing member and the external anchor.

[0011] In one embodiment, the tracheostomy sealing device is configured such that the tensile force increases non-linearly with the increase of the distance between the internal sealing member and the external anchor.

[0012] In one embodiment, the tracheostomy sealing device is configured such that the reciprocal of the tension relative to the distance between the inner sealing member and the outer anchor is greater at a smaller distance than at a larger distance.

[0013] In one embodiment, the tracheostomy sealing device is configured such that the reciprocal of the tension relative to the distance between the internal sealing member and the external anchor is approximately zero, which is above a maximum distance threshold.

[0014] In one embodiment, the tracheostomy sealing device includes a connecting element configured to apply the tension to the internal sealing member.

[0015] In an embodiment, the connecting element is configured such that the external anchor is configured to apply thrust and / or rotational force to the internal sealing member.

[0016] In one embodiment, the connecting element includes a wire connected to the inner sealing member, and wherein the wire is configured to apply the tension to the inner sealing member.

[0017] In one embodiment, the line is elastic, such that the tensile force increases as the distance between the inner sealing member and the outer anchor increases.

[0018] In one embodiment, the external anchor includes a biasing device connected to the line, the biasing device being configured such that the tension increases with the distance between the internal sealing member and the external anchor, optionally wherein the biasing device is one or more springs.

[0019] In one embodiment, the internal sealing member is configured such that the contact surface area between the internal sealing member and the patient increases as the tensile force increases.

[0020] In one embodiment, the internal sealing member is configured such that the contact surface area is generally annular.

[0021] In this embodiment, the internal sealing member and / or the external anchor are resilient.

[0022] In an embodiment, the tracheostomy sealing device is configured such that the tension is between about 0.1 N and about 30 N, optionally between 10 N and 30 N.

[0023] In an embodiment, the tracheostomy sealing device is configured such that the tension increases linearly between about 0.1 N and about 30 N, optionally between 10 N and 30 N.

[0024] In an embodiment, the tracheostomy sealing device is configured such that the internal sealing member applies a maximum pressure of approximately 500 cmH2O to approximately 700 cmH2O, optionally approximately 600 cmH2O. Attached Figure Description

[0025] To better understand the subject matter disclosed herein and to illustrate how the subject matter of the invention can be practiced, embodiments will now be described with reference to the accompanying drawings, by way of non-limiting example only, in which: Figure 1 It is a cross-sectional representation of the patient's tracheostomy; Figure 2 This is a schematic diagram of a tracheostomy sealing device; Figure 3 It shows Figure 2 A tracheostomy sealing device implanted in the patient's body; Figure 4 It shows how the tension F can change with... Figure 2 A diagram showing the variation in distance between the internal sealing component and the external anchor of the tracheostomy sealing device; Figure 5 It shows how the tension F can change with... Figure 2 Another diagram showing the variation in distance between the internal sealing component and the external anchor of the tracheostomy sealing device; Figure 6 This is yet another diagram showing how the tension F can vary with the distance between the internal sealing member and the external anchor of the tracheostomy sealing device; Figure 7 This is yet another diagram showing how the tension F can vary with the distance between the internal sealing member and the external anchor of the tracheostomy sealing device; Figure 8 This is another diagram showing how the tension F can vary with the distance between the internal sealing member and the external anchor of the tracheostomy sealing device; Figure 9 The configuration of the external anchors for the tracheostomy sealing device is shown; Figure 10 Another configuration of the external anchoring for the tracheostomy sealing device is shown; Figure 11 This illustrates yet another configuration of the external anchoring for the tracheostomy sealing device; and Figure 12A and 12B The tracheostomy sealing device is shown in two configurations in which the distance between the internal sealing member and the external anchor has been changed. Detailed Implementation

[0026] Figure 1 This diagram illustrates the anatomical structure of a patient's neck, showing the location of a surgically created passage (ostomy) through the neck into the trachea. This passage is called a tracheostomy (ostomy). Tracheostomies are created in many different clinical situations and may provide certain benefits to the patient. The surgical procedure used to create a tracheostomy is called a tracheostomy. Typically, during the creation of such a tracheostomy, a tube is inserted through the stoma to allow air to pass through in a controlled manner (this is called intubation). After a certain period of time (e.g., one week to several months), the tube is removed. The stoma is then allowed to heal and close. As mentioned above, air passing through the stoma can slow the patient's recovery and may also cause other complications and discomfort. Known devices can be used to seal the stoma. However, because the thickness of the neck can vary depending on the patient's position / movement, the sealing device may dislodge. This problem and other issues can be addressed / resolved through the following examples.

[0027] Figure 2This is a schematic diagram of a tracheostomy sealing device 100. Typically, the tracheostomy sealing device 100 is used to seal a patient's tracheostomy. The tracheostomy sealing device 100 can be used after treatment via the tracheostomy has been completed, and it is designed to allow the tracheostomy to heal. Tracheostomy healing can take several days to several weeks. The tracheostomy sealing device 100 can be configured for this healing period.

[0028] The tracheostomy sealing device 100 includes an internal sealing member 200. The tracheostomy sealing device 100 also includes an external anchor 300, which has a connecting element in the form of a line T.

[0029] The internal sealing member 200 is configured to be placed against the internal opening of the tracheostomy (inside the patient's trachea) in order to seal the internal opening of the tracheostomy.

[0030] The internal sealing member 200 can take many different forms / configurations. Figure 1 In the example shown, the internal sealing member 200 is typically disc-shaped. The disc-shaped plane of the internal sealing member 200 is configured to rest over the internal opening of the tracheostomy to form a seal. The internal sealing member 200 may have various structural / functional features to enhance its seal with the internal opening.

[0031] The internal sealing member 200 is configured to be inserted through the patient's tracheostomy (e.g., after the tracheostomy is no longer necessary for treatment and is intended to heal). For example, the internal sealing member 200 is configured to be inserted through a channel of no more than about 9.5 mm. This can be achieved by the internal sealing member 200 being able to fold into a shape suitable for this size. For example, the internal sealing member 200 can fold from a generally planar (disc) shape into a more compressed shape, which allows insertion through the tracheostomy (e.g., via an insertion device such as a sheath). Once inside the trachea, the internal sealing member 200 is configured to unfold to present a sealing configuration that allows it to form a seal against the tracheostomy. For disc-shaped members, this can be achieved by using an elastic material that ensures the disc unfolds into a more planar shape after insertion into the trachea, the more planar shape being wider than the tracheostomy.

[0032] The external anchor 300 is configured to be placed on the outside of the tracheostomy (e.g., on the patient's neck). Typically, the external anchor 300, after being deployed to seal the internal opening of the tracheostomy, serves to hold the internal sealing member 200 in place. The external anchor 300 applies a tensile force F to the internal sealing member 200, which holds the internal sealing member 200 in place above the internal opening of the tracheostomy. For this purpose, the external anchor 300 may include connecting elements, such as, but not limited to, a wire T (e.g., ...). Figure 1 As shown in the diagram, the line T is connected to the inner sealing member 200 (in some embodiments, the line T may be integral with the inner sealing member 200). The outer anchor 300, via the line T, pulls the inner sealing member 200 to hold it in place.

[0033] Figure 3 A cross-sectional view of a tracheostomy sealing device 100 implanted in a patient is shown. An internal sealing member 200 is placed in the trachea. The internal sealing member 200 is configured to be positioned over the tracheostomy, and specifically, over the internal opening of the tracheostomy. In this position, the internal sealing member 200 functions to seal the tracheostomy to prevent fluid and air contact with the air outside the patient's body. To hold the internal sealing member 200 in place, an external anchor 300 is placed outside the patient's body (on the skin of the neck). The external anchor 300 may be positioned generally opposite the internal sealing member 200. A T-shaped connecting element of the external anchor 300 passes through the stoma and is configured to pull the internal sealing member 200 to hold it in place.

[0034] As discussed in further detail below, the tracheostomy sealing device 100 is configured such that the tension F increases with the increase of the distance between the inner sealing member 200 and the outer anchor 300. Here, the distance between the inner sealing member 200 and the outer anchor 300 can refer to the spacing between them (e.g., as shown in the image). Figure 3 (The distance x is marked in the diagram). This distance x generally corresponds to the thickness of the patient's neck at the tracheostomy site. Other measurements of distance x may be used according to this disclosure.

[0035] An increase in the distance between the internal sealing member 200 and the external anchor 300 can be caused by patient movement, especially during exercise. In previous devices, any such movement could easily dislodge the internal sealing member, resulting in inadequate sealing of the tracheostomy. Because the tension F increases with the distance between the internal sealing member 200 and the external anchor 300, the internal sealing member 200 is less prone to movement, thus preventing accidental leakage. As described below, the tension F can vary in many different ways relative to the distance between the internal sealing member 200 and the external anchor 300. Some relationships are now described.

[0036] Figure 4 An example is shown where the tensile force F can vary with the distance between the inner sealing member 200 and the outer anchor 300. Typically, the tensile force F varies substantially linearly with the distance between the inner sealing member 200 and the outer anchor 300. In some embodiments, for example, as... Figure 4 As shown, the relationship between the minimum distance x minimum value and the maximum distance x maximum value holds true. The minimum distance and the maximum distance may be the normal operating range of the tracheostomy sealing device 100 (and may optionally depend on the specific patient).

[0037] The tracheostomy sealing device 100 is configured such that the tension F varies linearly with the distance between the internal sealing member 200 and the external anchor 300. This varying tension can be achieved using several different arrangements / configurations of the tracheostomy sealing device 100.

[0038] For example, the external anchor 300 may include a spring configured to bias the connecting element, such as line T. In such a configuration, as the distance between the internal sealing member 200 and the external anchor 300 increases, the spring acts to apply a larger restoring force (in a linear manner). The spring may be a spring that typically follows Hooke's law (e.g., a coil spring).

[0039] In other embodiments, the connecting element (e.g., wire T) can be elastic, thus acting as a biasing element. In such a configuration, the (elastic) connecting element applies a larger restoring force (linearly) as the distance between the inner sealing member 200 and the outer anchor 300 increases. The connecting element can typically follow Hooke's Law, or it can have other types of properties such that the tension on the inner sealing member 200 increases with the distance between the inner sealing member 200 and the outer anchor 300. In some embodiments, the connecting element can be elastic / formed from an elastic material (e.g., polymer / (natural) rubber). For example, the wire T can be an elastic wire, such as an elastic wire formed from polymer / (natural) rubber. In other embodiments, the connecting element can include a spring / spring-like structure. Compared to an elastic wire T, a spring / spring-like structure can be configured to achieve other elastic properties.

[0040] Depending on the choice of material or shape / form of the connecting element, the properties of tension relative to distance x may follow different kinds of curves.

[0041] In some embodiments, the connecting element may have additional / different purposes and / or modes. For example, the connecting element may be elastic and may be configured to generate tension between the inner sealing member 200 and the outer anchor 300, but remain rigid when pushed or rotated, such that the outer anchor 300 and the connecting element can be used to fold / unfold the inner sealing member 200 during insertion and removal.

[0042] Figure 5 An example is shown where the tensile force F can vary with the distance between the inner sealing member 200 and the outer anchor 300. Typically, the tensile force F varies in a generally non-linear manner with the distance between the inner sealing member 200 and the outer anchor 300.

[0043] like Figure 5 As shown, the reciprocal of the tension F relative to the distance between the inner sealing member 200 and the outer anchor 300 is maximum at smaller distance values ​​(e.g., around the minimum x value). At larger distances (e.g., around the maximum x value), the reciprocal decreases, optionally decreasing to zero. In this configuration, the tension F increases to a maximum when the distance first increases, allowing a large tension F to be applied when movement occurs. However, the increase in tension F is gradually reduced to avoid the tension F becoming excessive (causing patient pain / discomfort / damage to the tracheostomy seal device 100). This varying tension can be achieved using several different arrangements / configurations of the tracheostomy seal device 100. In some embodiments, this characteristic is achieved by using a mechanism included in the outer anchor 300. The mechanism can be a physical arrangement of arms exhibiting the characteristics mentioned above.

[0044] In other embodiments, the tensile curves mentioned above can be obtained by using special materials for the connecting elements. For example, the connecting elements may comprise or be composed of hyperelastic materials, such as shape memory alloys, and / or any other materials whose properties change upon reaching a certain strain or stress.

[0045] Figure 6 This illustrates yet another example of how the tensile force F can vary with the distance between the inner sealing member 200 and the outer anchor 300. In this example, for some increase in distance x (e.g., between the minimum x and the x offset), the tensile force F may be constant or nearly constant. When the distance increases beyond the x offset, another characteristic may dominate. This configuration may be used to ensure that the force does not increase (or increases slightly) during small / slight changes in x. Only when the distance x is large enough that there is a risk of detachment does a certain change in characteristic begin to dominate.

[0046] Therefore, the tracheostomy sealing device 100 is configured such that the reciprocal of the tension F relative to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller at smaller distances x than at larger distances x (e.g., approximately zero). In some embodiments, the tracheostomy sealing device 100 is configured such that the reciprocal of the tension F relative to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) in a first distance range (e.g., between the minimum value of x and the offset of x) than in a second distance range (e.g., greater than the offset of x). Optionally, the upper limit of the first distance range is lower than the lower limit of the second distance range.

[0047] Figure 7 This illustrates yet another example of how the tension F can vary with the distance between the internal sealing member 200 and the external anchor 300. In this example, the tension F may increase until it reaches a certain level of force, after which the increase in tension F decays to zero. In this configuration, the tracheostomy sealing device 100 can be configured to prevent the provision of tension exceeding an upper limit threshold maximum value of F, where the maximum value of F can be considered a traumatic or undesirable force to the tracheal mucosa surface.

[0048] Therefore, the tracheostomy sealing device 100 is configured such that the reciprocal of the tension F relative to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) at larger distances x than at smaller distances x. In some embodiments, the tracheostomy sealing device 100 is configured such that the reciprocal of the tension F relative to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) in a first distance range (e.g., greater than x decay) than in a second distance range (e.g., between the minimum value of x and x decay). Optionally, the upper limit of the second distance range is lower than the lower limit of the first distance range.

[0049] Figure 8 Another example is shown where the tension F can vary with the distance between the inner sealing member 200 and the outer anchor 300. In this configuration, the tension increases gradually with increasing distance x. It can be found that this configuration is acceptable whenever the evaluation considers that minor variations or fluctuations are permissible during periods of inactivity, and that the tension F should only increase significantly during more strenuous activity (e.g., vigorous movement during exercise) to prevent detachment.

[0050] Therefore, the tracheostomy sealing device 100 is configured such that the tensile force F relative to the reciprocal of the distance x between the inner sealing member 200 and the outer anchor 300 increases with increasing distance x. The tracheostomy sealing device 100 can be configured such that the tensile force F relative to the reciprocal of the distance x between the inner sealing member 200 and the outer anchor 300 continuously increases with increasing distance x. The tracheostomy sealing device 100 can be configured such that the tensile force F relative to the reciprocal of the distance x between the inner sealing member 200 and the outer anchor 300 continuously increases with increasing distance x within a range of distance x (e.g., between the minimum and maximum values ​​of x).

[0051] While the exemplary curves described herein include only one or two different combinations of curves, more advanced combinations of curves are possible to achieve more complex and customized properties. For example, in some embodiments, the tension F may be constant or nearly constant, followed by a gradual increase of the force F to another level of constant or nearly constant force. The steps represent a steep linear curve (or any other curve) from one level to another.

[0052] Figure 9 An embodiment is shown in which the external anchor 300 includes a mechanism configured to transform the spring 301 (e.g., a classical spring following Hooke's Law) into another property using a mechanism having a pivot point 302. Different transformations or properties can be obtained depending on the angle between the spring 301 and the connecting element (e.g., line T).

[0053] It should be understood that although the mechanism shown is a relatively simple type of conversion mechanism, much more complex mechanisms can be used to change the characteristics of, for example, a common spring to other types of tension characteristics. These mechanisms can include independent mechanisms that change the characteristics of the tension F into a smooth and continuous curve or characteristic. In other mechanisms, the curve may be steep / gradual, causing the tension F to vary differently over different distances x. This allows for different characteristics within each distance x interval.

[0054] Therefore, the external anchor 300 further includes a mechanism for attaching to the connecting element (e.g., line T). This mechanism may include a spring 301 and / or a pivot 302.

[0055] Figure 10 Another example of a mechanism that may be part of an external anchor 300 is shown. In this embodiment, two springs 301, 311 (e.g., classic springs / non-classical springs) work in series, for example, by making spring 301 softer than spring 311, or by making spring 301 a constant-force type, thereby allowing the connecting element (e.g., line T) to stretch a certain length until spring 301 is prevented from further compression / elongation, and only spring 311 can work together with further elongation of distance x. Thus, the tracheostomy seal device 100 is configured to apply curves with two different characteristics - for example Figure 6 The curve shown in the figure.

[0056] Therefore, the external anchor 300 may further include a mechanism attached to the connecting element (e.g., line T). The mechanism may include at least two springs (e.g., classic / non-classical springs). Optionally, the at least two springs may be connected in series with the connecting element (e.g., line T).

[0057] Figure 11 Another example of the mechanism of the external anchor 300 is shown, which includes an adjustable lever arm 304 attached to a spring 301 (e.g., a classical or non-classical spring), the spring 301 also being connected to a connecting element (e.g., a line T). Furthermore, the internal sealing member 200 can be configured to be flexible (e.g., elastically flexible). Thus, in this example, the tracheostomy sealing device 100 includes a spring 301 and an internal sealing member 200, which, in series, act as two flexible elements to produce the desired characteristics. Optionally, the external anchor 300 may include an adjustment mechanism 304. The adjustment mechanism 304 can be configured to offset the adjustable lever arm 304.

[0058] Therefore, the external anchor 300 may further include a mechanism for attaching to the connecting element (e.g., line T). This mechanism may include a spring 301. Optionally, the internal sealing member 200 is elastically flexible. Optionally, the spring 301 and the elastically flexible internal sealing member 200 are arranged in series to act as a spring.

[0059] In any of the embodiments disclosed herein, the internal sealing member 200 may be flexible, such as elasto-flexible. In some embodiments, the internal sealing member 200 may be configured such that the surface area configured to contact the trachea increases with increasing tension F. Such a configuration can partially compensate for the inherently larger contact pressure between the tracheal mucosa surface and the sealing member. Such a configuration can allow for a larger overall anchoring force to be applied between the tracheal mucosa and the sealing member without significantly increasing pressure (which reduces the likelihood of discomfort / injury). This is relative to... Figure 12A and 12B It was described in detail.

[0060] As in Figure 12A and 12B As seen in the diagram, the contact area S of the internal sealing element 200 varies with the tension F. As the tension F increases, the internal sealing element 200 deforms / bends, and the contact area S against the trachea increases, thereby maintaining the contact pressure at a desired low level. For example, the tension F may approximately double during an increase in distance x (e.g., between the minimum and maximum x). If the internal sealing member 200 is a rigid or hard element in which the constant edge of the element rests on the tracheal mucosa, the contact pressure will also approximately double. The device will be protected against dislodgement during patient movement, but the contact pressure may exceed a threshold considered safe to avoid damage or irritation to the tracheal mucosa. The elasticity and flexibility of the internal sealing member 200 can provide a mechanism in which the contact pressure does not increase proportionally with the tension F, thereby allowing a significant increase in the tension F without a proportional increase in the contact pressure.

[0061] Figure 12A The diagram shows a cross-sectional representation of a tracheostomy sealing device 100 implanted in a patient at a distance x (and tensile force F) h. In this state, the inner sealing member 200 contacts the tracheal mucosa through a region along the edge of the inner sealing member 200. This region can be represented using an average contact distance S1. Assuming the inner sealing member 200 is generally circular with a radius R, the region intersecting the mucosa can be represented as:

[0062] Given a tensile force F through the connecting element (e.g., wire T), the contact pressure from the internal sealing element toward the mucosa can be expressed as:

[0063] Therefore, if the force F doubles and Al remains the same, the contact pressure will also double.

[0064] On the other hand, if A increases with increasing tensile force F, the contact pressure can be maintained at a reasonable level. This is in Figure 12B The figure shows a cross-sectional representation of a tracheostomy sealing device 100 implanted in a patient at a distance x (and tension F). Figure 12B In this process, the same internal sealing member 200 undergoes (elastic) deformation due to a high tensile force F. During this deformation, the internal sealing member 200 can contact the tracheal mucosa to a greater extent. The average distance of the contact outer edge is defined as S2. S2 is greater than S1, thus creating a larger contact area A2. Therefore, even if F can be doubled, Rho will not increase to twice its value.

[0065] In some embodiments, the internal sealing member 200 is the most flexible part of the tracheostomy sealing device 100. In some embodiments, the internal sealing member 200 is more flexible than the external anchor 300 and / or connecting elements (e.g., wire T). In some embodiments, the external anchor 300 is substantially rigid. In some embodiments, the connecting elements (e.g., wire T) are substantially non-extensible.

[0066] For the configuration described above, the internal sealing member 200 is designed to be both flexible and elastic, so that as the distance x between the trachea and the outer skin increases, the internal sealing member 200 can help increase the tension F according to a certain profile / characteristic, and at the same time deform in a way that increases the contact area, which helps to keep the contact pressure low.

[0067] In some embodiments, the connecting element (e.g., the line T) may be the most flexible part of the tracheostomy sealing device 100. In some embodiments, the connecting element is more flexible than the internal sealing member 200 and / or the external anchor 300.

[0068] In the literature, the recommended maximum contact pressure for the contact area with the tracheal mucosa is 30 cmH2O. However, this maximum value is considered for medium to long-term exposure. Much higher values ​​(e.g., up to 20 times higher) are acceptable for very short time intervals. For example, the internal sealing member 200 can be configured to contact the tracheal mucosa with a 300 mm² area during patient rest, allowing the following tension:

[0069] During sudden movement, a tensile force up to twenty times higher can be allowed; in this example, this would be 16 N. During deformation of the internal sealing member 200, the area in contact with the mucosa may increase even further, or the sealing device may be of a larger size, which could allow the maximum short-term tensile force to reach up to 30 N without the risk of damaging the tracheal mucosa.

[0070] Therefore, in the arrangement disclosed herein, the maximum tensile force F can be 30 N during the extended distance x. Thus, this can be considered as the maximum value expected to be achieved when x is at its maximum value, or it can be the upper limit of the tensile force F before the characteristics tend to plateau and become almost constant (e.g., when the reciprocal of the tensile force F relative to the distance between the inner sealing member 200 and the outer anchor 300 is approximately zero).

[0071] In other embodiments, the tensile force F may have a low slope or may be substantially constant during normal mode, so that the tensile force increases only slightly as the distance x increases. This may be due to the fact that the device is expected to behave in a way that the tensile force increases only slightly even if the distance x may increase slightly. In some embodiments, the device may be configured such that the force F may increase by less than 1 N per centimeter as the distance x increases.

[0072] The bias force or base tension F (e.g., at the minimum value of x) can be applied by a practitioner during installation, and its level can range from 0.1 N to 10 N, depending on the type of contact between the internal sealing member 200 and the trachea. In some embodiments of the internal sealing member 200, the radius and area of ​​contact with the trachea may be small and limited. Therefore, the base tension F may be very low. In other embodiments, the base of the tension F can be 10 N, as the internal sealing member 200 may have a large surface area, which is acceptable for the trachea, thereby significantly reducing contact pressure.

[0073] Throughout this disclosure, references to elastic thread (or any other elastic element) may refer to a thread / element capable of spontaneously returning to its normal length / shape after being stretched beyond its equilibrium length, as will be understood by those skilled in the art. For example, an elastic thread / any other elastic element may comprise / compose of any combination of the following: elastin, rubber, nylon, Lycra, silicone, and polyester.

[0074] Throughout this disclosure, the tensile force can be characterized by any combination of the tensile forces described herein. For example, the tensile force can be characterized by a combination of a constant force range and a linearly increasing range. In another instance, multiple linearly increasing ranges can be combined with different inverse combinations of the tensile force F relative to the distance between the inner sealing member 200 and the outer anchor 300.

[0075] Although at least one exemplary embodiment has been presented in the foregoing detailed description, it should be understood that numerous variations exist.

[0076] It should also be understood that the exemplary embodiments are merely examples and are not intended to limit the scope, applicability, or configuration of this disclosure in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient way to implement one or more exemplary embodiments. It should be understood that various changes may be made to the function and arrangement of the elements without departing from the scope of this disclosure set forth in the appended claims and their legal equivalents.

Claims

1. A tracheostomy sealing device, comprising: An internal sealing member, the internal sealing member being inserted through a patient's tracheostomy, the internal sealing member being configured to seal the internal opening of the tracheostomy; and External anchors, which are placed on the outside of the tracheostomy. The external anchor is configured to apply tension to the internal sealing member to hold it against the internal opening of the tracheostomy, thereby sealing the internal opening. The tracheostomy sealing device is configured such that the tensile force increases with the increase of the distance between the internal sealing member and the external anchor.

2. The tracheostomy sealing device according to claim 1, wherein the tracheostomy sealing device is configured such that the tensile force increases linearly with the increase of the distance between the internal sealing member and the external anchor.

3. The tracheostomy sealing device according to claim 1, wherein the tracheostomy sealing device is configured such that the tensile force increases non-linearly with the increase of the distance between the internal sealing member and the external anchor.

4. The tracheostomy sealing device of claim 3, wherein the tracheostomy sealing device is configured such that the tensile force relative to the reciprocal of the distance between the inner sealing member and the outer anchor is greater at a smaller distance than at a larger distance.

5. The tracheostomy sealing device according to any one of the preceding claims, wherein the tracheostomy sealing device is configured such that the reciprocal of the tension relative to the distance between the inner sealing member and the outer anchor is approximately zero, which is above a maximum distance threshold.

6. The tracheostomy sealing device according to any one of the preceding claims, comprising a connecting element configured to apply the tension to the internal sealing member.

7. The tracheostomy sealing device of claim 6, wherein the connecting element is configured such that the external anchor is configured to apply a thrust and / or rotational force to the internal sealing member.

8. The tracheostomy sealing device of claim 6, wherein the connecting element comprises a wire connected to the internal sealing member, and wherein the wire is configured to apply the tension to the internal sealing member.

9. The tracheostomy sealing device according to claim 8, wherein the line is elastic, such that the tensile force increases with the increase of the distance between the inner sealing member and the outer anchor.

10. The tracheostomy sealing device according to claim 8 or 9, wherein the external anchor includes a biasing device connected to the line, the biasing device being configured such that the tension increases with the distance between the internal sealing member and the external anchor, optionally wherein the biasing device is one or more springs.

11. The tracheostomy sealing device according to any one of the preceding claims, wherein the internal sealing member is configured such that the contact surface area between the internal sealing member and the patient increases as the tensile force increases.

12. The tracheostomy sealing device of claim 11, wherein the internal sealing member is configured such that the contact surface area is generally annular.

13. The tracheostomy sealing device according to any one of the preceding claims, wherein the internal sealing member and / or the external anchor is resilient.

14. The tracheostomy sealing device according to any one of the preceding claims, wherein the tracheostomy sealing device is configured such that the tensile force is between about 0.1 N and about 30 N, optionally between 10 N and 30 N, and optionally wherein the tracheostomy sealing device is configured such that the tensile force increases linearly between about 0.1 N and about 30 N, optionally between 10 N and 30 N.

15. The tracheostomy sealing device according to any one of the preceding claims, wherein the tracheostomy sealing device is configured such that the internal sealing member is subjected to a maximum pressure of about 500 cmH2O to about 700 cmH2O, optionally about 600 cmH2O.

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