TECHNICAL FIELD

Aspects of the present disclosure relate generally to a mechanical pressure indicator, and more specifically, but not by way of limitation, to a mechanical pressure indicator for a dressing and/or a system for oxygen therapy and related methods.

BACKGROUND

Clinical studies and practice have shown that oxygen therapy in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. Applications of this phenomenon are numerous, but have proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, care of the wound can impact the outcome. Treatment of wounds with oxygen therapy may be commonly referred to as “hyperbaric oxygen wound therapy,” but is also known by other names, including “hyperbaric oxygen therapy,” “positive-pressure therapy,” “positive pressure wound therapy,” and “hyperbaric therapy,” as illustrative, non-limiting examples. Oxygen therapy may provide one or more benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, reduced infection, and/or micro-deformation of tissue at a wound site. These benefits can increase development of granulation tissue and reduce healing times.

Oxygen therapy is typically provided by a positive-pressure system (e.g., a pressurized system or a hyperbaric system) including one or more components and/or one or more devices. To illustrate, a conventional positive-pressure system may include a dressing, one or more tubes, a therapy device (e.g., a positive-pressure source), or a combination thereof, as illustrative, non-limiting examples. The dressing may be placed at a tissue site and coupled to the positive-pressure source via the tube. The positive-pressure source is configured to establish positive-pressure (e.g., a hyperbaric environment) at the dressing and the dressing is configured to maintain the positive-pressure at the tissue site.

However, excess positive-pressure at the dressing and tissue site can restrict or close capillaries, which reduces blood flow and increases healing times. Additionally, a user may be unaware of such a situation and damage can occur. To address excess positive-pressure (e.g., an overpressure condition), dressings and/or therapy systems have specific and/or dedicated electronic monitoring, sensors, etc., to regulate the pressure at the tissue site. Additionally, dressings and/or therapy systems may include back-up systems and/or safety measures, such as automatic shut off and/or alarms to notify a user. To illustrate, a dressing may include expensive regulators and electronic components to facilitate pressure monitoring and/or regulation at the dressing and tissue site. These components add size, weight, and rigidity to the dressing, which decreases efficacy and patient comfort.

SUMMARY

This disclosure describes devices, systems, and methods related to a pressure indicator, such as a mechanical indicator, coupled to a connector for a dressing. The connector and/or the dressing may be associated with a hyperbaric oxygen therapy system, that includes pressure indication by a mechanical indicator. The dressing is configured to be coupled to a tissue site and, when coupled to the tissue site, defines a cavity to which pressure-pressure is applied to create a pressurized, oxygen-rich environment (e.g., an environment having a higher concentration of oxygen that atmospheric or ambient air). The connector coupled to dressing includes a connector body (e.g., a housing) configured to define at least a portion of a first channel. The connector further includes a viewing member (e.g., a window) coupled to the connector body and a deformable member (e.g., a deformable indicator) positioned within the first channel and viewable through the viewing member.

The deformable member is configured to deform responsive to positive-pressure associated with the tissue site to provide one or more visual indications of pressure. For example, the deformable member deforms under increasing positive-pressure to move or expand towards the viewing member to provide a particular visual indication of pressure. As an illustrative, non-limiting example, when exposed to a first pressure above a threshold pressure, the deformable member deforms such that a portion of the deformable member contacts a portion of the viewing member. The portion of the deformable member in contact with the viewing member may be clearly visible through the viewing member. When exposed to a second pressure below the threshold pressure, the deformable member may not deform (or may deform to a lesser extent as compared to when exposed to the first pressure above the threshold pressure) such that at least a portion of the deformable member is partially occluded the viewing member (e.g., not clearly visible through the viewing member). Thus, a user (e.g., a patient or care provider) can determine a pressure state or an operational state of the dressing/connector based on the visual indication of the deformable member.

To illustrate, when the deformable member does not provide a particular visual indication (e.g., is not visible via the viewing member or is partially occluded by the viewing member), the deformable member may provide a first indication, such as the dressing connector is in a non-operational or neutral-pressure state. That is, a lack of a visual indication can still provide an indication of pressure or status to the patient or care provider. When the deformable member provides a particular visual indication (e.g., is visible via the viewing member), the deformable member provides a second indication, such as the dressing/connector is in an operational or positive-pressure state, or an overpressure state.

In some implementations in which the second indication corresponds to the dressing/connector in an operational or positive-pressure state, the connector body is configured to provide a second visual indication (e.g., a third indication). For example, the connector body includes a second deformable indicator configured to deform responsive to another pressure threshold to provide the second visual indication which indicates excess positive-pressure or an overpressure state. When the deformable member is exposed to the higher pressure and is deformed to a greater extent, an additional portion of the deformable member is visible via the viewing member. In a particular implementation, the additional portion of the deformable member has a different color or marking from first portion of the deformable member visible via the viewing member when the deformable member is exposed to an operational positive-pressure, such as a pressure greater than or equal to the pressure threshold (e.g., a first pressure threshold), and less than or equal to the other pressure threshold (e.g., a second pressure threshold).

In some implementations, the connector further includes a pressure relief valve. The pressure relief valve may be positioned within a second channel (or integrated into the connector body) defined by the connector body and configured to enable flow based on the pressure associated with a tissue site. For example, the pressure relief valve may move or deform to create an opening in the second channel, thereby enabling pressure in the first cavity to be released via the second channel.

Thus, the connector (e.g., the deformable member) of the present disclosure is configured to enable mechanical pressure indication. For example, the deformable member provides a visual indication of a pressure range and is configured to respond to different pressures by deforming to provide a corresponding visual indication. To illustrate, when the connector is coupled to a positive-pressure source (e.g., a pressurized oxygen source) such that positive-pressure (e.g., pressurized oxygen) is provided to the cavity associated with a tissue site, the deformable member deforms to indicate that a pressure associated with the tissue site is at a particular pressure or within a range. The range indicated by the deformable member may correspond to a range of pressures associated with hyperbaric therapy and thus, the deformable member indicates that hyperbaric therapy is being applied to the tissue site. Therefore, a patient or care provider can determine a pressure and/or operational statues of the dressing and/or therapy applied to the tissue site and adjust or regulate the pressure accordingly.

Additionally, the connector of the present disclosure may be configured to enable mechanical pressure regulation. For example, the pressure relief valve is configured to enable flow based on the pressure of cavity and tissue site when the pressure is greater than equal to a threshold value. To illustrate, when the connector is coupled to the positive-pressure source such that excess positive-pressure is provided to the cavity, the pressure relief valve deforms to vent excess pressure and reduce or limit an amount of positive-pressure applied to the tissue site. Reducing/limiting the amount of positive-pressure at the tissue site enables the connector to advantageously avoid excess positive-pressure at the tissue site when the connector is coupled to a positive-pressure source, such as an unregulated pressure source. Additionally, the connector beneficially provides an ability to reduce and/or limit the delivery of positive-pressure to the tissue site such that capillaries of the tissue site remain open. Accordingly, effective, efficient, and safe positive-pressure therapy may be achieved through use of the flexible mechanical indicators and regulators, thereby advancing connector flexibility and patient comfort and confidence in the treatment.

Some embodiments of the present apparatuses (e.g., of a connector) comprise: a connector body configured to define at least a portion of a first channel; a viewing member coupled to the connector body; and a deformable member positioned within the first channel and configured to deform based on a pressure of a cavity partially defined by the deformable member and to provide a visual indication, via the viewing member, of the pressure of the cavity. In some implementations of the embodiments of the present apparatuses, the deformable member is configured to provide a first visual indication, via the viewing member, when the pressure of the cavity is greater than or equal to a first threshold. In a particular implementation, the deformable member comprises an elastic polymer. Additionally, or alternatively, in one or more implementations, the deformable member has a hardness in the range of 10 Shore A to 20 Shore A.

In some of the foregoing embodiments of the present apparatuses, the cavity is distinct from a second cavity defined by the connector body, the viewing member.

Additionally, or alternatively, the deformable member, and the deformable member is configured to deform responsive to a force resulting from a pressure differential between the cavity and the second cavity.

In some of the foregoing embodiments of the present apparatuses, the deformable member is configured to deform to transition between a first state and a second state; when the deformable member is in the first state, the deformable member is configured to indicate a neutral pressure state; and/or when the deformable member is in the second state, at least a portion of the deformable member is viewable through the viewing member and configured to indicate a positive-pressure state. In some such implementations, the first state comprises an undeformed state, and the second state comprises a deformed state. Additionally, or alternatively, when the deformable member is in the first state, the deformable member does not contact the viewing member; and/or when the deformable member is in the second state, at least a first portion of the deformable member contacts the viewing member. In a particular implementation, the first portion has a first color or marking.

In some of the foregoing embodiments of the present apparatuses, the deformable member is configured to provide a second visual indication, via the viewing member, when the pressure of the cavity is greater than or equal to a second threshold. Additionally, or alternatively, the deformable member is configured to deform to transition between the second state and a third state. In some such implementations, when the deformable member is in the third state, at least a second portion of the deformable member contacts the viewing member; the second portion has a second color or marking that is different from the first color or marking of the first portion; and/or and the first state corresponds to a first range of pressures, the second state corresponds to a second range of pressures, and the third state corresponds to a third range of pressures. In a particular implementation, the second visual indication indicates an over-pressure state. Additionally, or alternatively, is one or more implementations, the deformable member is configured to transition to the second state between 10 mm Hg and 22 mm Hg.

In some of the foregoing embodiments of the present apparatuses, the apparatuses (e.g., the connector) further comprises a pressure relief valve positioned within a second channel defined by the connector body and configured to enable flow when the pressure of the cavity is greater than equal to a threshold value. In some such implementations, the pressure relief valve includes a valve selected from the group consisting of: a duckbill valve, an umbrella valve, and a combination duckbill umbrella valve; and, optionally, the pressure relief valve has a hardness in the range of 40 Shore A to 60 Shore A. In a particular implementations, the threshold value associated with the pressure relief valve is between 22 mm Hg and 35 mm Hg. Additionally, or alternatively, the pressure relief valve may be configured to generate an audio indication responsive to flow through the pressure relief valve.

In some of the foregoing embodiments of the present apparatuses, the viewing member comprises a window. In some such implementations, the window comprises a transparent material or a translucent material such that the deformable member is at least partially occluded by the window in when the deformable member is in the first state and is visible via the window when the deformable member is in a second state. In a particular implementation, the window comprises frosted glass and is semi-opaque. In some of the foregoing embodiments of the present apparatuses, the deformable member comprises a first material that is different from a second material of the viewing member such that the first material does not adhere to the second material when the deformable member contacts the viewing member.

In some of the foregoing embodiments of the present apparatuses, the apparatuses (e.g., the connector) further comprises a hydrophobic filter configured to prevent liquid from flowing from the cavity to the pressure relief valve. Additionally, or alternatively, the apparatuses (e.g., the connector) further comprises a second deformable member configured to deform to indicate an over pressurized state. In some such implementations, the apparatuses (e.g., the connector) further comprises a second viewing member, where the second deformable member is positioned in the first channel and visible via the second viewing member. In a particular implementation, the deformable member and the second deformable member are integrated into a deformable indicator, and the deformable member comprises a first portion of the deformable indicator and the second deformable member comprises a second portion of the deformable indicator

In some of the foregoing embodiments of the present apparatuses, the connector is configured to be coupled to a positive-pressure dressing. In some such implementations, the apparatuses (e.g., the connector) further comprises a second deformable member configured to deform to indicate a reduced-pressure state.

Some embodiments of the present apparatuses (e.g., of a dressing) comprise: a connector the comprises: a connector body configured to define at least a portion of a first channel; a viewing member coupled to the connector body; and a deformable member positioned within the first channel and configured to deform based on a pressure of a cavity partially defined by the deformable member and to provide a visual indication, via the viewing member, of the pressure of the cavity; and a drape coupled to the connector and configured to be coupled to a tissue site. In some implementations of the embodiments of the present apparatuses, the dressing further comprises a tube configured to be coupled to the connector and comprising one or more lumens. In some such implementations, the tube is coupled to a port of the connector, and/or the tube comprises multiple lumens including a primary lumen, one or more ancillary lumens, or a combination thereof.

Some embodiments of the present system comprise: a dressing the comprises: a connector the comprises: a connector body configured to define at least a portion of a first channel; a viewing member coupled to the connector body; and a deformable member positioned within the first channel and configured to deform based on a pressure of a cavity partially defined by the deformable member and to provide a visual indication, via the viewing member, of the pressure of the cavity; and a drape coupled to the connector and configured to be coupled to a tissue site; and a positive-pressure source configured to be coupled to the connector via one or more tubes. In some such implementations, the positive-pressure source is configured to provide pressurized oxygen to the dressing, and/or the positive-pressure source comprises an oxygen tank or an oxygen collector.

Some embodiments of the present methods comprise: providing, by an positive-pressure source, pressurized oxygen to a dressing coupled to a tissue site of a patient, where the dressing comprises: a connector that comprises: a connector body configured to define at least a portion of a first channel; a viewing member coupled to the connector body; and a deformable member positioned within the first channel and configured to deform based on a pressure of a cavity partially defined by the deformable member and to provide a visual indication, via the viewing member, of the pressure of the cavity; and a drape coupled to the connector and configured to be coupled to the tissue site; and responsive to the pressurized oxygen provided to the dressing, deforming the deformable member to indicate a positive-pressure state at the tissue site. In some implementations of the embodiments of the present methods, the methods further comprise responsive to excess pressurized oxygen provided to the dressing, deforming the pressure relief valve to form an opening in the dressing; and releasing the excess pressurized oxygen from the dressing via the opening.

As used herein, various terminology is for the purpose of describing particular implementations only and is not intended to be limiting of implementations. For example, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not by itself indicate any priority or order of the element with respect to another element, but rather merely distinguishes the element from another element having a same name (but for use of the ordinal term). The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. Additionally, two items that are “coupled” may be unitary with each other. To illustrate, components may be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, communicational (e.g., wired or wireless), or chemical coupling (such as a chemical bond) in some contexts.

The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. As used herein, the term “approximately” may be substituted with “within 10 percent of” what is specified. Additionally, the term “substantially” may be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, or 5 percent; or may be understood to mean with a design, manufacture, or measurement tolerance. The phrase “and/or” means and or. To illustrate, A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C. In other words, “and/or” operates as an inclusive or.

The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), and “include” (and any form of include, such as “includes” and “including”). As a result, an apparatus that “comprises,” “has,” or “includes” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, a method that “comprises,” “has,” or “includes” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.

Any aspect of any of the systems, methods, and article of manufacture can consist of or consist essentially of—rather than comprise/have/include—any of the described steps, elements, and/or features. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb. Additionally, it will be understood that the term “wherein” may be used interchangeably with “where.”

Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.

Some details associated with the aspects of the present disclosure are described above, and others are described below. Other implementations, advantages, and features of the present disclosure will become apparent after review of the entire application, including the following sections: Brief Description of the Drawings, Detailed Description, and the Claims.

