Tracheostomy sealing device

Abstract

A tracheostomy sealing device is provided, comprising an inner sealing member for insertion through a patient's tracheostomy, the inner sealing member being configured to seal the inner opening of the tracheostomy, and an outer anchor for placement outside the tracheostomy, the outer anchor being configured to apply a tensile force to the inner sealing member to hold the inner sealing member at the inner opening of the tracheostomy, thereby sealing the inner opening, and the tracheostomy sealing device being configured such that the tensile force increases as the distance between the inner sealing member and the outer anchor increases.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to a tracheostomy stoma sealing device comprising an inner seal member and an outer anchor, and more specifically to a tracheostomy stoma sealing device comprising an inner seal member and an outer anchor, wherein the outer anchor applies a tensile force to the inner seal member such that the tensile force increases as the distance between the inner seal member and the outer anchor increases.

BACKGROUND ART

[0002] A tracheostomy tube is a short curved tube that is inserted through a surgical hole in a patient's neck and held in place around the patient's neck with a tracheostomy tie. The purpose of the tracheostomy tube is to provide the patient with an airway, or to provide the patient with access that facilitates suction of secretions from the airway.

[0003] Patients have tracheostomy tubes placed for various reasons. When the reason that necessitated the placement of the tracheostomy tube is resolved, the tracheostomy tube is usually removed. This procedure is known as extubation. After the patient is extubated, a hole known as a stoma remains in the patient's neck. When the patient is extubated, the stoma normally closes on its own in the majority of patients. This usually occurs in 2 to 3 weeks. Surgical closure of the stoma is necessary for patients whose stoma does not close on its own.

[0004] Currently, when a patient is extubated, an occlusive or simply gauze bandage type arrangement is placed on the patient for several days following extubation. Once the patient leaves the hospital, and in some cases even within the hospital such as from the intensive care unit to a regular care unit, the usual method for covering the stoma is to use a bandage. The patient is then instructed to cover the stoma with a finger when the patient needs to speak or cough.

[0005] This method of covering the fistula with a bandage and using a finger to occlude it for speaking has several drawbacks. Firstly, the patient may not be physically able to occlude the fistula with their finger when necessary. Secondly, in all patients, if the fistula is not covered in a somewhat airtight manner, the air entering and leaving the fistula when the patient tries to speak will make it difficult (or even impossible) for the patient to speak. Thirdly, if the patient coughs without covering the fistula, air will be pushed out of the fistula, and even with normal breathing, if it is only covered with a bandage, air may enter and leave the fistula. This movement of air through the fistula reduces the likelihood of it closing on its own without surgery. Fourthly, touching the fistula with the patient's finger to speak or cough significantly increases the likelihood of infection of the patient's fistula and airway, which can lead to contamination and the spread of infection. Fifth, with existing products, the pressure over the fistula is not constant, and air leaks out while talking or coughing, causing the patient to lose the ability to cough effectively. There is also a risk of atelectasis (collapse or closure of the alveoli), which may result from a lack of post-expiratory pressure and can affect part or all of the lung, leading to decreased ventilation with reduced or absent gas exchange. Atelectasis is often correlated with mucus buildup and, in some cases, can lead to pneumonia.

[0006] Existing products may aim to solve any / all of the above problems by providing a sealing device for sealing fistulas. In certain existing products, the sealing element is placed on the inside of the patient's neck to seal the internal opening of the fistula, and the outer element is placed on the patient's skin to secure the sealing element in place (e.g., using sutures).

[0007] However, sealing elements placed on the inside of the patient's neck are potentially prone to falling out (e.g., during patient movement), which could reduce the effectiveness of the fistula seal.

[0008] Therefore, it is desirable to provide an improved device for sealing fistulas that are less likely to fall out. Furthermore, other desirable properties and features of this disclosure will become apparent from the subsequent detailed description and the appended claims, in conjunction with the accompanying drawings and the aforementioned technical field and background. [Overview of the project]

[0009] In one embodiment, a tracheostomy sealing device is provided, comprising an inner sealing member for insertion through a patient's tracheostomy, the inner sealing member being configured to seal the inner opening of the tracheostomy, and an outer anchor for placement outside the tracheostomy, the outer anchor being configured to apply a tensile force to the inner sealing member to hold the inner sealing member at the inner opening of the tracheostomy, thereby sealing the inner opening, and the tracheostomy sealing device being configured such that the tensile force increases as the distance between the inner sealing member and the outer anchor increases.

[0010] In one embodiment, the tracheostomy sealing device is configured such that the tensile force increases linearly as the distance between the inner sealing member and the outer anchor increases.

[0011] In one embodiment, the tracheostomy sealing device is configured such that the tensile force increases non-linearly as the distance between the inner sealing member and the outer anchor increases.

[0012] In the embodiment, the tracheostomy sealing device is configured such that the derivative of the tensile force with respect to the distance between the inner sealing member and the outer anchor is greater at shorter distances than at longer distances.

[0013] In this embodiment, the tracheostomy sealing device is configured such that the derivative of the tensile force with respect to the distance between the inner sealing member and the outer anchor is approximately zero when it exceeds a maximum distance threshold.

[0014] In one embodiment, the tracheostomy sealing device includes a connecting element configured to apply a tensile force to an inner sealing member.

[0015] In this embodiment, the connecting element is configured such that the outer anchor can apply pressing and / or rotational force to the inner sealing member.

[0016] In the embodiment, the connecting element comprises a thread connected to an inner sealing member, and the thread is configured to apply a tensile force to the inner sealing member.

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

[0018] In the embodiment, the outer anchor comprises a biasing means connected to a thread, the biasing means configured to increase the tensile force as the distance between the inner sealing member and the outer anchor increases, and optionally the biasing means is one or more springs.

[0019] In this embodiment, the inner sealing member is configured such that the contact area of ​​the inner sealing member with the patient increases as the tensile force increases.

[0020] In this embodiment, the inner sealing member is configured such that its contact area is substantially ring-shaped.

[0021] In the embodiment, the inner sealing member and / or outer anchor are elastic.

[0022] In this embodiment, the tracheostomy sealing device is configured such that the tensile force is approximately 0.1N to approximately 30N, and optionally 10N to 30N.

[0023] In this embodiment, the tracheostomy sealing device is configured such that the tensile force increases linearly from approximately 0.1 N to approximately 30 N, and optionally from 10 N to 30 N.

[0024] In an embodiment, the tracheal fistula sealing device is configured such that the inner sealing member exerts a maximum pressure of approximately 500 cmH₂O to approximately 700 cmH₂O, optionally approximately 600 cmH₂O.

[0025] For a better understanding of the subject matter disclosed in the present specification and to illustrate how it may be practically implemented, embodiments are described by way of non-limiting example with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] [Figure 1] It is a cross-sectional view of a tracheal fistula in a patient. [Figure 2] It is a schematic view of a tracheal fistula sealing device. [Figure 3] It shows the tracheal fistula sealing device of Figure 2 implanted in a patient. [Figure 4] It is a graph showing how the tensile force F may vary with the distance between the inner sealing member and the outer anchor of the tracheal fistula sealing device of Figure 2. [Figure 5] It is another graph showing how the tensile force F may vary with the distance between the inner sealing member and the outer anchor of the tracheal fistula sealing device of Figure 2. [Figure 6] It is still another graph showing how the tensile force F may vary with the distance between the inner sealing member and the outer anchor of the tracheal fistula sealing device. [Figure 7] It is still another graph showing how the tensile force F may vary with the distance between the inner sealing member and the outer anchor of the tracheal fistula sealing device. [Figure 8] It is another graph showing how the tensile force F may vary with the distance between the inner sealing member and the outer anchor of the tracheal fistula sealing device. [Figure 9] It shows the configuration of the outer anchor of the tracheal fistula sealing device. [Figure 10]Another configuration of the external anchor for the tracheostomy sealing device is shown. [Figure 11] This shows yet another configuration of the external anchor for the tracheostomy sealing device. [Figure 12A] The diagram shows two configurations of tracheostomy sealing devices with varying distances between the inner sealing member and the outer anchor. [Figure 12B] The diagram shows two configurations of tracheostomy sealing devices with varying distances between the inner sealing member and the outer anchor. [Modes for carrying out the invention]

[0027] Figure 1 shows the anatomical structure of the patient's neck and the location of a surgically formed passage (fistula) that enters the patient's trachea through the patient's neck. This is called a tracheostomy (fistula). Tracheostomies can form in many different clinical situations and can provide certain benefits to the patient. The surgical procedure to form a tracheostomy is called a tracheostomy. Typically, when such a tracheostomy is formed, a tube is inserted through the fistula to allow air to pass through in a controlled manner (this is called intubation). After a certain period (e.g., a week to several months), the tube is removed. The fistula is then allowed to heal and close. As mentioned above, the passage of air through the fistula can delay the patient's recovery and may cause other complications and discomfort. Known devices can be used to seal the fistula. However, sealing devices may fall out because the thickness of the neck can change depending on the position / movement taken by the patient. This problem and other problems can be addressed / resolved by the following embodiments.

[0028] Figure 2 shows a schematic diagram of the tracheostomy sealing device 100. Generally, the tracheostomy sealing device 100 is for sealing a patient's tracheostomy. The tracheostomy sealing device 100 may be used when treatment via the tracheostomy is complete and healing of the tracheostomy is intended. Healing of a tracheostomy can take several days to several weeks. The tracheostomy sealing device 100 may be configured for use during such a healing period.

[0029] The tracheostomy sealing device 100 comprises an internal sealing member 200. The tracheostomy sealing device 100 also comprises an external anchor 300 having a connecting element in the form of a thread T.

[0030] The inner sealing member 200 is configured to be positioned relative to the inner opening of the tracheostomy site (the inside of the patient's trachea) so as to seal the inner opening of the tracheostomy site.

[0031] The inner sealing member 200 can take many different forms / configurations. In the embodiment shown in Figure 1, the inner sealing member 200 is substantially disc-shaped. The disc-shaped plane of the inner sealing member 200 is configured to be positioned over the inner opening of the tracheostomy to form a seal. The inner sealing member 200 may have various structural / functional properties to improve the seal with the inner opening.

[0032] The inner sealing member 200 is configured to be inserted through the patient's tracheoma (for example, after the tracheoma is no longer needed for treatment and is intended to heal). For example, the inner sealing member 200 is configured to be inserted through a passage of about 9.5 mm or less. This can be achieved by the inner sealing member 200 being able to fold to a shape that fits within this dimension. For example, the inner sealing member 200 can fold from a generally planar (disk) shape to a more compressed shape that allows insertion through the tracheostomy (for example, via an insertion device such as a sheath). Once inside the trachea, the inner sealing member 200 is configured to expand to assume a sealing configuration that allows it to form a seal against the tracheostomy. In the case of a disc-shaped member, this can be achieved by using an elastic material that ensures the disc unfolds into a flatter shape when inserted into the trachea, which is wider than the tracheostomy.

[0033] The outer anchor 300 is configured to be positioned outside the tracheostomy site (for example, on the patient's neck). Generally, when deployed to seal the internal opening of the tracheostomy site, the outer anchor 300 acts to hold the internal sealing member 200 in place. The outer anchor 300 applies a tensile force F to the internal sealing member 200, holding it in place above the internal opening of the tracheostomy site. For this purpose, the outer anchor 300 may include, but is not limited to, a connecting element such as a thread T (as shown in Figure 1) connected to the internal sealing member 200 (in certain embodiments, the thread T may be integral with the internal sealing member 200). The outer anchor 300 via the thread T acts to pull the internal sealing member 200 in place.

[0034] Figure 3 shows a cross-sectional view of a tracheostomy sealing device 100 implanted in a patient. The inner sealing member 200 is positioned in the trachea. The inner sealing member 200 is configured to be positioned over the tracheostomy, particularly over the inner opening of the tracheostomy. In such a position, the inner sealing member 200 acts to seal the tracheostomy from fluid and air connections to the outside air of the patient. To hold the inner sealing member 200 in place, an outer anchor 300 is positioned on the outside of the patient (on the skin of the neck). The outer anchor 300 may be positioned generally opposite the inner sealing member 200. The connecting element of the outer anchor 300, in the form of a thread T, is configured to pass through the fistula and pull the inner sealing member 200 to hold it in place.

[0035] As will be discussed in more detail below, the tracheostomy sealing device 100 is configured such that the tensile force F increases as the distance between the inner sealing member 200 and the outer anchor 300 increases. In this specification, the distance between the inner sealing member 200 and the outer anchor 300 may refer to the distance between the inner sealing member 200 and the outer anchor 300 (for example, as marked by distance x in Figure 3). This distance x may generally correspond to the diameter of the patient's neck at the tracheostomy. Other measurements of distance x may be used in accordance with this disclosure.

[0036] An increase in the distance between the inner sealing member 200 and the outer anchor 300 can be caused by patient movement, particularly during exercise. In previous devices, any such movement tended to dislodge the inner sealing member, resulting in improper sealing of the tracheostomy site. As the distance between the inner sealing member 200 and the outer anchor 300 increases, the tensile force F increases, causing the inner sealing member 200 to become less mobile and resulting in unintended leakage, as described below. The tensile force F can vary in many different ways with respect to the distance between the inner sealing member 200 and the outer anchor 300. Herein lies a specific relationship.

[0037] Figure 4 shows a graph illustrating an example of how the tensile force F may vary with respect to the distance between the inner sealing member 200 and the outer anchor 300. Generally, the tensile force F varies generally linearly with respect to the distance between the inner sealing member 200 and the outer anchor 300. In certain embodiments, for example, as shown in Figure 4, the relationship holds between a minimum distance xmin and a maximum distance xmax. The minimum and maximum distances may be the normal operating range of the tracheostomy sealing device 100 (optionally, depending on the specific patient).

[0038] The tracheostomy sealing device 100 is configured such that the tensile force F generally changes linearly with respect to the distance between the inner sealing member 200 and the outer anchor 300. Several different arrangements / configurations of the tracheostomy sealing device 100 may be used to obtain such a changing tensile force.

[0039] For example, the outer anchor 300 may include a spring configured to bias a connecting element, such as a thread T. In such a configuration, as the distance between the inner sealing member 200 and the outer anchor 300 increases, the spring acts to apply a greater restoring force (linearly). The spring may generally be a spring that obeys Hooke's law (e.g., a helical spring).

[0040] In other embodiments, the connecting element, for example, the thread T, may be elastic so as to function as a biasing element. In such a configuration, as the distance between the inner seal member 200 and the outer anchor 300 increases, the (elastic) connecting element acts to apply a greater restoring force (linearly). The connecting element may generally obey Hooke's Law, or it may possess other types of features such that the tensile force on the inner seal member 200 increases as the distance between the inner seal member 200 and the outer anchor 300 increases. In some embodiments, the connecting element may be elastic / formed from an elastic material (e.g., polymer / (natural) rubber). For example, the thread T may be an elastic thread formed from, for example, a polymer / (natural) rubber. In other embodiments, the connecting element may comprise a spring / spring-like structure. The spring / spring-like structure may be configured to achieve other elastic properties compared to the elastic tensile thread T.

[0041] Depending on the choice of material or shape / form of the connecting element, the characteristics of the tensile force with respect to distance x may follow different types of curves.

[0042] In some embodiments, the connecting element may have additional / different purposes and / or modes. For example, the connecting element may be elastic and configured to generate tensile force between the inner sealing member 200 and the outer anchor 300, or it may be rigid when pressed or rotated so that the outer anchor 300 and the connecting element can be used to fold / unfold the inner sealing member 200 during insertion and removal.

[0043] Figure 5 shows a graph illustrating an example of how the tensile force F may change with respect to the distance between the inner seal member 200 and the outer anchor 300. Generally, the tensile force F changes generally nonlinearly with respect to the distance between the inner seal member 200 and the outer anchor 300.

[0044] As shown in Figure 5, the derivative of the tensile force F with respect to the distance between the inner sealing member 200 and the outer anchor 300 is maximum at smaller distances (e.g., around xmin). At larger distances (e.g., around xmax), the derivative decreases to zero, of course. In such a configuration, the tensile force F increases to a maximum at the initial increase in distance so that a large tensile force F can be applied when movement occurs. However, the increase in the tensile force F tapers off to avoid the tensile force F becoming too large (causing pain / discomfort to the patient / damage to the tracheostomy sealing device 100). Several different arrangements / configurations of the tracheostomy sealing device 100 can be used to obtain such a variable tensile force. In some embodiments, such features are obtained by using a mechanism provided in the outer anchor 300. The mechanism may be a physical arrangement of arms that presents the above features.

[0045] In other embodiments, the tensile force curve described above may be obtained by using special materials for the connecting elements. For example, the connecting elements may include / consist of memory alloys or other superelastic materials and / or any other materials whose properties change when a certain strain or stress is reached.

[0046] Figure 6 illustrates yet another embodiment of how the tensile force F may vary with the distance between the inner sealing member 200 and the outer anchor 300. In this embodiment, the tensile force F may be constant or nearly constant for a certain increase in the distance x (e.g., between xmin and xbias). As the distance increases beyond xbias, another characteristic may take over. Such a configuration may be useful to ensure that the force does not increase (or increases to a minimal extent) during small / minor changes in x. Only when the distance x becomes sufficiently large and there is a risk of detachment does a change in a certain characteristic begin to take over.

[0047] Therefore, the tracheostomy sealing device 100 is configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) for smaller distances x than for larger distances x. In a particular embodiment, the tracheostomy sealing device 100 is configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) for a first distance range (e.g., between xmin and xbias) than for a second distance range (e.g., greater than xbias). Optionally, the upper limit of the first distance range is lower than the lower limit of the second distance range.

[0048] Figure 7 illustrates yet another embodiment of how the tensile force F may vary with the distance between the inner sealing member 200 and the outer anchor 300. In this embodiment, the tensile force F may increase until it reaches a certain level of force after the increase in the tensile force F decays to zero. In such a configuration, the tracheostomy sealing device 100 may be configured to prevent providing a tensile force exceeding an upper threshold Fmax, where Fmax may be a force considered traumatic or undesirable to the inner lining of the tracheal mucosa.

[0049] Therefore, the tracheostomy sealing device 100 is configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) at greater distances x than at smaller distances x. In a particular embodiment, the tracheostomy sealing device 100 is configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 is smaller (e.g., approximately zero) at first distance ranges (e.g., greater than xdecay) than at second distance ranges (e.g., between xmin and xdecay). Optionally, the upper limit of the second distance range is lower than the lower limit of the first distance range.

[0050] Figure 8 shows another embodiment of how the tensile force F may vary with the distance between the inner sealing member 200 and the outer anchor 300. In this configuration, the tensile force increases in increasing proportion to the distance x. Such a configuration may prove useful whenever it is assessed that slight changes or fluctuations may / are acceptable during periods of inactivity, and only during more intense activity (e.g., vigorous movement during motion) should the tensile force F be significantly increased to avoid detachment.

[0051] Therefore, the tracheostomy sealing device 100 is configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 increases as the distance x increases. The tracheostomy sealing device 100 may be configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 increases continuously as the distance x increases. The tracheostomy sealing device 100 may be configured such that the derivative of the tensile force F with respect to the distance x between the inner sealing member 200 and the outer anchor 300 increases continuously as the distance x increases within a range of distance x (e.g., between xmin and xmax).

[0052] The exemplary curves described herein include only one or two different curves combined, but more advanced combinations of curves may be possible to achieve more complex and tuned features. For example, in some embodiments, the tensile force F may be constant or nearly constant, and then the force F may be gradually increased to another level of constant or nearly constant force; a step representing a steep linear curve (or any other arbitrary curve) from one level to another.

[0053] Figure 9 illustrates an embodiment in which the outer anchor 300 is configured to transform a spring 301 (e.g., a classical spring following Hooke's Law) into a different feature by using a mechanism having a pivot point 302. Different transformations or features can be obtained depending on the angle between the spring 301 and the connecting element (e.g., thread T).

[0054] Although the illustrated mechanism is a relatively simple type of transformation mechanism, it should be understood that much more complex mechanisms can be used, for example, by changing the characteristics of a normal spring to those of other types of tensile force characteristics. These mechanisms may include independent mechanisms that change the characteristics of the tensile force F to a single smooth and continuous curve or characteristic. In other mechanisms, the curve may be abrupt / stepped so that the tensile force F changes differently over different ranges of distance x. This allows for different characteristics within each distance x interval.

[0055] Therefore, the outer anchor 300 further comprises a mechanism attached to a connecting element (e.g., thread T). The mechanism may include a spring 301 and / or a pivot 302.

[0056] Figure 10 illustrates another embodiment of the mechanism, which may be part of the outer anchor 300. In this embodiment, two springs 301, 311 (e.g., classical spring / non-classical spring) act in series such that, for example, spring 301 is softer than spring 311, or spring 301 is of a constant force type, allowing the connecting element (e.g., thread T) to stretch a certain length until spring 301 is prevented from further compression / extension, while only spring 311 can function with further extension of distance x. Thus, the tracheostomy sealing device 100 is configured to exhibit two different characteristic curves, for example, the curve illustrated in Figure 6.

[0057] Therefore, the outer anchor 300 may further comprise a mechanism attached to a connecting element (e.g., thread T). The mechanism may comprise at least two springs (e.g., classical springs / non-classical springs). Optionally, at least two springs may be connected in series with the connecting element (e.g., thread T).

[0058] Figure 11 illustrates yet another embodiment of the mechanism of an outer anchor 300, comprising an adjustable lever arm 304 attached to a spring 301 (e.g., a classical or non-classical spring), the spring 301 also connected to a connecting element (e.g., a thread T). Furthermore, the inner sealing member 200 may be configured to be flexible (e.g., elastically flexible). Thus, in this embodiment, the tracheostomy sealing device 100 comprises the spring 301 and the inner sealing member 200, which function as two flexible elements in series to produce the desired features. Optionally, the outer anchor 300 may include an adjustment mechanism 304, which may be configured to offset the adjustable lever arm 304.

[0059] Therefore, the outer anchor 300 may further comprise a mechanism attached to a connecting element (e.g., thread T). The mechanism may comprise a spring 301. Optionally, the inner sealing member 200 is elastically flexible. Optionally, the spring 301 and the elastically flexible inner sealing member 200 are arranged to function in series as a spring.

[0060] In any embodiment disclosed herein, the inner sealing member 200 may be flexible, for example, elastically flexible. In certain embodiments, the inner sealing member 200 may be configured such that the surface area configured to contact the trachea increases as the tensile force F increases. Such a configuration may partially compensate for any other greater contact pressure between the tracheal mucosa surface and the sealing member. Such a configuration may allow for the application of a greater overall fixing force between the tracheal mucosa and the sealing member (reducing the possibility of discomfort / injury) without significantly increasing the pressure. This will be described in detail with respect to Figures 12A and 12B.

[0061] As seen in Figures 12A and 12B, the contact area S of the inner sealing element 200 changes with respect to the tensile force F. As the tensile force F increases, the inner sealing element 200 deforms / bends, the contact area S with respect to the trachea increases, and therefore maintains the contact pressure at a lower level than desired. For example, the tensile force F may approximately double during an increase in distance x (e.g., between xmin and xmax). If the inner sealing member 200 is a rigid or stiff element with a constant rim of the element placed on the tracheal mucosa, the contact pressure will also approximately double. The device is secured from falling out during patient movement, but the contact pressure may exceed a threshold that is considered safe to avoid damaging or irritating the tracheal mucosa. The elasticity and flexibility of the inner sealing member 200 may provide a mechanism in which the contact pressure does not increase proportionally with the tensile force F, thereby allowing for a significant increase in the tensile force F without proportionally increasing the contact pressure.

[0062] Figure 12A shows a cross-sectional view of the tracheostomy sealing device 100 implanted in a patient when the distance x (and tensile force F) is small. In this state, the inner sealing member 200 is in contact with the tracheal mucosa by a region along the rim of the inner sealing member 200. The area can be expressed using the average contact distance SI. Assuming that the inner sealing member 200 is approximately circular with radius R, the region intersecting the mucosa can be expressed as follows: A1 = π(R2 - (R - S1)2)

[0063] When a tensile force F is applied through a connecting element (e.g., thread T), the contact pressure from the inner sealing element toward the mucosa can be expressed as follows: Rho=F / A1

[0064] Therefore, if the force F doubles and Al remains the same, the contact pressure also doubles.

[0065] On the other hand, if A increases with an increased tensile force F, the contact pressure can be maintained at a reasonable level. This is illustrated in Figure 12B, which illustrates a cross-sectional view of a tracheostomy sealing device 100 implanted in a patient when the distance x (and tensile force F) is large. In Figure 12B, the same inner sealing member 200 undergoes (elastic) deformation due to a higher tensile force F. During such deformation, the inner sealing member 200 can contact the tracheal mucosa to a greater extent. The average distance of the contacting outer rim is defined as S2. S2 is greater than SI, which gives a larger contact area A2. Therefore, Rho does not increase to twice its value, even if F could be doubled.

[0066] In some embodiments, the inner sealing member 200 is the most flexible part of the tracheostomy sealing device 100. In certain embodiments, the inner sealing member 200 is more flexible than the outer anchor 300 and / or connecting element (e.g., thread T). In certain embodiments, the outer anchor 300 is substantially rigid. In certain embodiments, the connecting element (e.g., thread T) is substantially non-stretchable.

[0067] In the above configuration, the inner sealing member 200 is designed to possess both flexibility and elasticity so that, while the distance x between the trachea and the outer skin is increasing, the inner sealing member 200 can help increase the tensile force F according to a certain profile / characteristic, deform in a way that increases the contact area, and at the same time help keep the contact pressure low.

[0068] In some embodiments, a connecting element (e.g., thread T) may be the most flexible part of the tracheostomy sealing device 100. In certain embodiments, the connecting element is more flexible than the inner sealing member 200 and / or the outer anchor 300.

[0069] In the literature, the recommended maximum contact pressure for the area in contact with the tracheal mucosa is 30 cmH2O. However, this maximum value is considered to occur during medium- and long-term exposure. During very short time slots, much higher values ​​(e.g., up to 20 times higher) can be accepted. For example, the inner sealing member 200 may be configured to contact the tracheal mucosa over an area of ​​300 mm2 during the patient's rest period, allowing for the following tensile forces: F=pxA=2.94kPa*300mm²=0.8N

[0070] During sudden movements, the tensile force can increase 20-fold, reaching 16 N in this embodiment. During deformation of the inner sealing member 200, the area in contact with the mucous membrane can be further increased, or the sealing device can have a larger size, which can increase the short-term maximum tensile force to up to 30 N without the risk of damaging the tracheal mucosa.

[0071] Therefore, in the configuration disclosed herein, the maximum tensile force F may be 30 N during elongation of distance x. Thus, this can be considered either the maximum value that is expected to be reached at the maximum value of x, or the upper limit of the tensile force F, before the feature reaches a transverse state and becomes nearly constant (for example, the derivative of the tensile force F with respect to the distance between the inner sealing member 200 and the outer anchor 300 is approximately zero).

[0072] In other embodiments, the tensile force F characteristic in normal mode may have a lower slope or be substantially constant, with a slight increase in tensile force as distance x increases. This may be due to the fact that it is desirable for the device characteristics to behave such that the tensile force increases only slightly, even though distance x may increase somewhat. In some embodiments, the device may be configured such that the force F can increase by less than 1 N per 1 cm increase in distance x.

[0073] The biasing force or base tensile force F (e.g., at x min) may be applied by the operator during installation and may have a level of 0.1 N to 10 N depending on the type of contact between the inner sealing member 200 and the trachea. In some embodiments of the inner sealing member 200, the radius and area of ​​contact with the trachea may be small and limited. Therefore, the base tensile force F may be very low. In other embodiments, the tensile force F may have a base of 10 N because the inner sealing member 200 may have a large surface area that is highly adaptable to the trachea, thus significantly reducing the contact pressure.

[0074] Throughout this disclosure, references to elastic yarns (or any other elastic elements) may refer to yarns / elements that, as understood by those skilled in the art, can spontaneously recover their normal length / shape after being stretched beyond their equilibrium length. For example, elastic yarns / any other elastic elements may include, or consist of, any combination of elastane, rubber, nylon, Lycra, silicone, and polyester.

[0075] Throughout this disclosure, tensile forces may be characterized by any combination of the tensile forces described herein. For example, a tensile force may be characterized by a constant force interval combined with a linearly increasing interval. In another embodiment, several linearly increasing intervals may be combined with different derivatives of the tensile force F with respect to the distance between the inner sealing member 200 and the outer anchor 300.

[0076] While at least one exemplary embodiment has been presented in the detailed description above, it should be understood that a vast number of variations exist.

[0077] Furthermore, it should be understood that the exemplary embodiments are merely examples and are not intended to limit in any way the scope, applicability, or configuration of this disclosure. Rather, the detailed description above provides a convenient roadmap for carrying out the exemplary embodiments for those skilled in the art. It should be understood that various modifications can be made to the function and arrangement of the elements without departing from the scope of this disclosure as set forth in the appended claims and their legal equivalents.

Claims

1. A tracheostomy sealing device, An internal sealing member for insertion through a patient's tracheostomy, wherein the internal sealing member is configured to seal the internal opening of the tracheostomy, It comprises an external anchor for placement outside the tracheostomy site, The outer anchor is configured to apply tensile force to the inner sealing member in order to hold the inner sealing member in the inner opening of the tracheostomy, thereby sealing the inner opening. A tracheostomy sealing device configured such that the tensile force increases as the distance between the inner sealing member and the outer anchor increases.

2. The tracheostomy sealing device according to claim 1, wherein the tracheostomy sealing device is configured such that the tensile force increases linearly as the distance between the inner sealing member and the outer anchor increases.

3. The tracheostomy sealing device according to claim 1, wherein the tracheostomy sealing device is configured such that the tensile force increases non-linearly as the distance between the inner sealing member and the outer anchor increases.

4. The tracheostomy sealing device according to claim 3, wherein the tracheostomy sealing device is configured such that the derivative of the tensile force with respect to 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 prior claims, wherein the tracheostomy sealing device is configured such that the derivative of the tensile force with respect to the distance between the inner sealing member and the outer anchor becomes approximately zero when it exceeds a maximum distance threshold.

6. A tracheostomy sealing device according to any one of the prior claims, comprising a connecting element configured to apply the tensile force to the inner sealing member.

7. The tracheostomy sealing device according to claim 6, wherein the connecting element is configured such that the outer anchor can apply pressing and / or rotational force to the inner sealing member.

8. The tracheostomy sealing device according to claim 6, wherein the connecting element comprises a thread connected to the inner sealing member, and the thread is configured to apply the tensile force to the inner sealing member.

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

10. The tracheostomy sealing device according to claim 8 or 9, wherein the outer anchor comprises a biasing means connected to the thread, the biasing means configured to increase the tensile force as the distance between the inner sealing member and the outer anchor increases, and optionally the biasing means is one or more springs.

11. The tracheostomy sealing device according to any one of the prior claims, wherein the inner sealing member is configured such that the contact area of ​​the inner sealing member with the patient increases as the tensile force increases.

12. The tracheostomy sealing device according to claim 11, wherein the inner sealing member is configured to have a contact area that is substantially ring-shaped.

13. The tracheostomy sealing device according to any one of the prior claims, wherein the inner sealing member and / or the outer anchor is elastic.

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

15. The tracheostomy sealing device according to any one of the prior claims, wherein the inner sealing member is configured to exert a maximum pressure of approximately 500 cmH2O to approximately 700 cmH2O, and optionally approximately 600 cmH2O.

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