Patent ID: 12233223

DETAILED DESCRIPTION

FIG.1shows an example embodiment of a securement device100to secure a medical tube inserted into a patient. As illustrated inFIG.1, the securement device100includes an attachment pad102configured to interface with the surface of the skin of a patient for attachment of the securement device to the skin. The attachment pad102is preferably made of materials sufficiently flexible to conform to the topography of a patient's skin. The attachment pad102includes a distal side104that faces away from the patient's skin during use and a proximal side (not shown) opposite the distal side104. The proximal side of the attachment pad102faces and is configured to contact the skin for attachment to a patient. As used herein, “proximal” refers to relative positioning toward the skin of a patient during use of the securement device100and “distal” refers to positioning away from the skin of the patient during use of the securement pad100. In preferred implementations, the attachment pad102includes an adhesive layer with an adhesive surface exposed on the proximal side of the attachment pad through which the attachment pad102may be adhered to the skin of the patient during use. Although not preferred, the attachment pad102could be attached to the skin of a patient, or attachment to the skin could be aided by other securement means, for example by taping the attachment pad to skin with tape extending across the distal side104of the attachment pad102and with the tape adhered to the skin beyond the periphery of the attachment pad102, or through the use of sutures.

The securement device100includes a securement sleeve106that is coupled to the attachment pad104adjacent a proximal end of the securement sleeve106. In the example embodiment of the securement device100illustrated inFIG.1, a coupling structure through which the securement sleeve106is coupled to the attachment pad102includes a flared proximal end portion of the securement sleeve disposed between and adhered to a first surface on the distal side104of the attachment pad102and an opposing second surface on a proximal side of a base member108. In this example, the coupling structure includes adhesive disposed between the opposing surfaces of the attachment pad102and base member108adhering together the opposing surfaces and the intermediate flared proximal end portion of the securement sleeve106sandwiched between the opposing surfaces of the attachment pad102and the base member108. The distal end of the securement sleeve106is coupled to and retained by a distal collar110.

The securement device100also includes a rotating member112that is engaged with an extension portion114of the base member108that projects through an aperture in the rotatable member112and is rotatably retained in a circular groove track extending around the perimeter of the extension portion114of the base member108.

The securement device100includes a tube passage116extending in a longitudinal direction through the distal collar110, the securement sleeve106, the base member108, and the attachment pad102. The tube passage116has a proximal end open on the proximal side of the attachment pad102and a distal end open on a distal end of the distal collar110. As illustrated inFIG.1, the tube passage116has a longitudinal axis118extending in the longitudinal direction of the tube passage between the proximal end of the tube passage116and the distal end of the tube passage116.

The securement sleeve106includes a securement portion122in which a medical tube extending through the tube passage116can be gripped by the securement sleeve106to secure the medical tube to the securement device100during use. During use, the securement device100can be attached to the skin of a patient and the medical tube can be disposed through the tube passage116and into the body of the patient, and the medical tube with the desired positioning in the patient can be secured to the securement device100by the securement portion122of the securement sleeve106to retain the medical tube in a fixed position relative to securement device100and relative to the patient to which the securement device100is attached.

FIG.2illustrates an example of the securement device100in use attached to skin124of a patient with a medical tube120extending through the tube passage116and with a proximal end126of the medical tube120disposed at a desired location in the body of the patient. The medical tube120held in place by securement to the securement device100by the securement sleeve106gripping the medical tube120in the tube passage116in the securement portion122.

With continued reference toFIGS.1and2, unlike the proximal end of the securement sleeve106which is in a fixed position relative to the base member108and the attachment pad102, the distal end of the securement sleeve106is not in a fixed position relative to the base member108and the attachment pad102. The securement sleeve106will be of a flexible construction, and the position of the distal end of the securement sleeve106relative to the base member108and the attachment pad102may be varied, for example by bending the securement sleeve106intermediately between the base member108and the distal collar110. As will be appreciated, when the securement sleeve106is bent, the tube passage116and the longitudinal axis118of the tube passage116through the securement sleeve106will also be bent within the bent portion of the securement sleeve106. As will also be appreciated, when the securement sleeve106is bent the medical tube120will be bent within the bent portion of the securement sleeve106when the medical tube120is disposed through the tube passage116as illustrated inFIG.2.

The securement sleeve106of the securement device100illustrated inFIGS.1and2has a variable-length property, wherein the longitudinal length of the securement sleeve106between the proximal and distal ends of the securement sleeve106varies depending upon whether and to what extent the securement sleeve is subjected to longitudinally-applied force. For example, the securement sleeve106may be subjected to a longitudinally-applied compressive force by pushing the distal collar110toward the base member108and the attachment pad102to reduce the length of the securement sleeve106, and the securement sleeve106may be subjected to a longitudinally-applied tensile force by pulling the distal collar110away from the base member108and the attachment pad102to increase the length of the securement sleeve106. The magnitude of such a longitudinally-applied force will affect the magnitude by which the length of the securement sleeve106is decreased, in the case of longitudinally-applied compressive force, or increased, in the case of longitudinally-applied tensile force.

The securement portion122is a longitudinal portion of the securement sleeve106that lengthens and shortens with changes in longitudinally-applied force to which the securement sleeve106, and correspondingly to which the securement portion122, is subjected. The cross-sectional area of the tube passage116, transverse to the longitudinal path of the tube passage along the longitudinal axis118, expands as the securement sleeve106is shortened and contracts as the securement sleeve106is lengthened. As will be appreciated, when the securement sleeve106is shortened by longitudinally-applied compression, the length of the securement portion122is correspondingly shortened and the cross-sectional area of the tube passage expands, and a medical tube having an outside cross-section small enough to fit through the expanded cross-sectional area of the tube passage116may be inserted through the tube passage116in the securement portion122. If the outside cross-section of the medical tube has a maximum cross-dimension (e.g., outer diameter of a circular tube cross-section) that is larger than a corresponding maximum cross-dimension of the tube passage116when the securement sleeve106is in a relaxed state (under no longitudinally-applied compression or tension) then when the longitudinally-applied compression is released with a medical tube disposed through the tube passage the inside wall surfaces of the securement portion122will grip the medical tube within the tube passage to secure the medical tube to the securement sleeve106.

The securement portion122of the securement sleeve106represents a longitudinal portion of the securement sleeve106in which the cross-sectional area of the tube passage116in the securement sleeve may be varied by reducing the length of the securement sleeve106to permit insertion of a medical tube through an enlarged cross-sectional area of the tube passage116and then increasing the length of the securement sleeve106to reduce the cross-sectional area of the tube passage to grip and hold the medical tube. As will be appreciated, the securement portion122may make up varying longitudinal portions of the securement sleeve106depending upon the particular configuration of the securement sleeve106, including materials of construction, construction geometry and the coupling structures with which the proximal end and the distal end of the securement sleeve106are engaged. For example, portions of the securement sleeve106in close proximity to coupling structures may be prevented by engagement with those coupling structures from sufficiently contracting in cross-section to grip a medical tube disposed through the tube passage116. Likewise, the longitudinal length of such end portions unavailable to grip a medical tube may depend upon the particular size (e.g., outside diameter) of the medical tube to be gripped within the securement sleeve106. As will also be appreciated, the securement portion122may not necessarily have a uniformly-sized cross-sectional area of the tube passage116at all longitudinal points within the securement portion122. For example, when the securement sleeve106is in a state of longitudinally-applied compression, the cross-sectional area of the tube passage116may be somewhat larger, or bulged, near a longitudinal midpoint of the securement portion122relative to the tube passage116closer to the proximal and distal ends of the securement portion122where the cross-sectional area of the tube passage116may be more affected by coupling structures with which the securement sleeve106is engaged. Similarly, when the securement sleeve106is in a state of longitudinally-applied tension, the cross-sectional area of the tube passage116may be somewhat smaller near a longitudinal midpoint of the securement portion122than closer to the proximal and distal ends of the securement portion122where the cross-sectional area of the tube passage116may be more affected by coupling structures with which the securement sleeve106is engaged. As a consequence of possible variations in the cross-sectional area of the tube passage116through the securement portion122, when in a compressed state with an enlarged cross-section, the tube passage may have a minimum cross-sectional area at one or more longitudinal points in the securement portion122that define a minimum insertion cross-section for receipt of a medical tube inserted through the securement portion122. In some implementations, with the securement portion122in a compressed state to receive insertion of a medical tube, the minimum insertion cross-section may be defined by the cross-sectional area of the tube passage116adjacent proximal and/or distal coupling structures.

Reference is now made toFIGS.3-8, together withFIGS.1-2, to further discuss features of the securement portion122of the securement sleeve106of the securement device100illustrated inFIGS.1and2.FIGS.3,5and7each shows a longitudinal part of the securement portion122, but illustrated in different states having different sizes for the cross-sectional area of the tube passage116through the securement portion122.FIGS.4,6and8are corresponding sectional views of the securement portion122illustrated inFIGS.3,5and7, respectively, taken transverse to the longitudinal direction of the tube passage116.FIGS.3,5and7show differences in the cross-sectional area of the tube passage116in the different illustrated states.FIGS.3and4illustrate the securement portion122alone, with the securement portion122in a relaxed state with no longitudinally-applied force, and in the relaxed state the cross-sectional area of the tube passage116is too small to receive for securement a medical tube of a size for which the securement portion122is designed to secure to the securement device100.FIGS.5and6illustrate the securement portion122in a compressed state with the securement portion122subjected to longitudinally-applied compressive force, illustrated by the arrows shown inFIG.5. In the compressed state ofFIGS.5and6, the cross-sectional area of the tube passage116is expanded relative to the relaxed state illustrated inFIGS.3and4.FIGS.5and6show the medical tube120received through the tube passage116in the securement portion122, and illustrate that in this compressed state the outer cross-section of the medical tube120is smaller than the cross-sectional area of the tube passage116.FIGS.7and8then illustrate the securement portion122with the medical tube120disposed through the tube passage116after the longitudinally-applied compression ofFIGS.5and6has been released, permitting the securement portion122to relax sufficiently to grip the medical tube120in the tube passage116, for securement of the medical tube120to the securement device100. As will be appreciated, the medical tube120illustrated inFIGS.7and8can be released from being gripped by the securement portion122to permit the medical tube120to be repositioned relative to the securement portion122or to be removed entirely from the securement portion122. In this way, a medical tube inserted into a patient and held by the securement device100may be repositioned within the patient's body or removed and replaced with a different medical tube. The new or repositioned medical tube may then be secured to the securement device100by again releasing the securement portion122of longitudinally-applied compression to permit the securement sleeve106to relax and grip the new or repositioned medical tube. In other situations, after release of the medical tube120from securement, the securement device100can be removed from the patient without removing the medical tube from the patient, and a new securement device100can then be attached to the patient, for example if attachment of the prior securement device100to the patient becomes compromised, or to clean the wound and/or replace wound dressings. In still other situations, both the medical tube120and the securement device100may be replaced with a new medical tube and a new securement device100.

Reference is now made primarily toFIGS.9and10, together withFIGS.1-8.FIGS.9and10show the securement device100ofFIG.1attached to the skin124of a patient during use and with the medical tube120disposed through the securement sleeve106and into the body of the patient. The securement device100includes a bent sleeve holder130, which in the illustrated embodiment of the securement device100includes a retaining channel132configured to selectively receive and hold a longitudinal portion of the securement sleeve106to retain the securement sleeve106in a bent configuration in which a distal portion of the securement sleeve106is biased toward the skin124, and toward an attachment plane of the attachment pad102. As referred to herein, an attachment plane of the attachment pad102refers to a plane perpendicular to the longitudinal axis118of the tube passage116at a point where the tube passage116is open at a proximal side of the attachment pad102. The holder130includes flexible tabs134a,bthat are sufficiently flexible to permit the securement sleeve106to be pushed into the channel132, with the flexible tabs134a,btemporarily deflecting to the sides as the securement sleeve106is pushed into the retaining channel132.FIG.9shows the securement sleeve106being pushed into the retaining channel132with the flexible tabs134a,bdeflecting to the sides as the securement sleeve106is pushed into the retaining channel132. The flexible tabs134a,bshould have sufficient rigidity, however, to retain the received portion of the securement sleeve106in the retaining channel132to retain the securement sleeve106in a bent configuration, as illustrated inFIG.10. As illustrated inFIG.10, in the bent configuration the securement sleeve106has a bend136through a portion of the securement sleeve106between the proximal end of the securement sleeve106and the retaining channel132. In the bent configuration, a portion of the securement sleeve106distal of the bend136is biased toward the skin124and an attachment plane of the attachment pad102, and with a relatively small standoff of the securement sleeve106from the attachment pad102and the surrounding skin124of the patient. The securement sleeve106may be released from the bent configuration by pulling the securement sleeve106out of the retaining channel132, with the flexible tabs134a,btemporarily deflecting as the securement sleeve106is removed from the retaining channel132. As illustrated inFIG.10, in the bent configuration the securement sleeve106is bent through an angle of approximately 90°, although as will be appreciated the bent sleeve holder130could be configured to retain the securement sleeve106with a bend through an angle greater than or less than 90°. The tabs134a,bmay be made of any material of construction, for example metallic or polymeric materials of construction, and preferably of a polymeric material (and more preferably a thermoplastic elastomer), providing a desired level of both flexibility to elastically deform and permit the securement sleeve106to be pushed into and removed from the channel132and to otherwise hold the securement sleeve106in the bent configuration when the received portion of the securement sleeve106is received in the receiving channel132. The configuration illustrated inFIGS.9and10illustrate one preferred implementation in which the bent sleeve holder130receives and retains a longitudinal portion of the securement portion122of the securement sleeve106, and with the bend136also including a longitudinal portion of the securement portion122.

One advantage of the securement device100configured to selectively retain the securement sleeve in the bent configuration as illustrated inFIG.10is that after positioning the medical tube as desired in the patient's body and after securing the medical tube120to the securement device100with the medical tube120gripped by the securement portion122of the securement sleeve106, then the medical tube120may be conveniently positioned and held in the bent configuration with a relatively close standoff from the patient, significantly reducing possibility for accidental or unintended interactions with the securement sleeve106or the medical tube120by the patient or a medical practitioner. Additionally, the design provides advantageous flexibility to easily release the securement sleeve106from the bent configuration to permit manipulation of the securement sleeve106to release the medical tube120to permit the medical tube120to be repositioned, to permit removal of the medical tube120from the patient, or to permit removal and replacement of the securement device100without repositioning or removal of the medical tube. Another advantage is that in the bent configuration, the bend136provides additional resistance to release of the securement portion122from gripping the medical tube120if the patient or medical practitioner should intentionally or inadvertently push on the distal collar110to impart a longitudinally-applied compression to the securement sleeve106that could otherwise lead to an undesired release of the medical tube120from securement by the securement sleeve106and an undesired movement of the medical tube120. The bend136helps to resist an inadvertent release of the medical tube120from being secured by the securement sleeve106. Additionally, the structure defining the channel132will provide some resistance to enlargement of the cross-section of the securement sleeve106within the channel to permit enlargement of the cross-sectional area of the tube passage116within the securement portion122to release the medical tube from securement. The bent configuration also advantageously provides additional resistance to someone pushing on the medical tube120toward the distal collar110or pulling the medical tube120away from the distal collar110with sufficient force to overcome the force with which the medical tube120is held by the securement sleeve106. As will be appreciated from the illustration ofFIG.10, if someone, such as the patient, pushes the medical tube120toward the distal collar110or pulls the medical tube120away from the distal collar110, the bend136provides additional resistance to movement of the medical tube120through the securement sleeve106.

Reference is now made toFIGS.11-15, together withFIGS.1-10, in relation to describing a rotational feature of the securement device100permitting the bent sleeve holder130to be rotated to and positioned at various radial positions relative to the attachment pad102. In the example securement device100illustrated inFIGS.1and2, the bent sleeve holder130is mounted on the rotating member112, which is selectively rotatable relative to the base member108to permit the bent sleeve holder130to be positioned at different radial positions relative to the attachment pad102. More particularly, the rotating member112has an aperture140(seen best inFIG.12) through which the extension portion114of the base member108extends and the rotating member112is received in and rotatably retained by a circular groove track extending around the perimeter of the extension portion114, whereby the extension portion114acts as an axle about which the rotating member112is rotatable to radially position the bent sleeve holder130. As will be appreciated, in the example configuration of the securement device100the longitudinal axis118of the tube passage116through the attachment pad102is coaxial with an aperture through the extension portion114about which the rotating member112rotates, and accordingly the different radial positions at which the bent sleeve holder130may be positioned are radially spaced about the longitudinal axis118of the tube passage116through the attachment pad102.

The securement device100includes a radial positioning lock to selectively lock the bent sleeve holder130at different radial positions. The rotatable member112and the base member108have complementary interlocking lock structures that can be selectively engaged to lock the radial position of the rotating member112at different radial positions. In the illustrated example of the securement device100the base member108has a plurality of recesses142spaced radially around the base member108and the rotating member112has a plurality of projections144, and the projections144are configured to be receivable in the recesses142to lock the rotating member112in a fixed radial position relative to the base member108. As illustrated inFIG.11, the rotating member112is made of a material that is suitably flexible to permit a portion of the rotating member112to be elastically deformed to disengage the projections144from the recesses142to permit the rotating member112to be rotated relative to the base member108, as indicated by the rotational arrow inFIG.11. After rotating the rotating member112to a desired radial position, the elastically deformable portion of the rotating member112may be manipulated to engage the projections144with corresponding ones of the recesses142to lock the rotating member112at that radial position. A manipulation tab146on the rotating member112may be used by a person to manipulate the elastically deformable portion of the rotating member112to engage and disengage the projections144from the recesses142and to rotate the rotating member112relative to the base member108and to then engage the projections144with corresponding ones of the recesses142at a new radial position. Preferably, the recesses142are continued around the complete periphery of the rotating member112, and the rotating member112and the bent sleeve holder130are rotatable fully 360° about the longitudinal axis118as an axis of rotation to permit the rotating member112and the bent sleeve holder130to be positioned at various radial positions about the axis of rotation.FIGS.13-15illustrate the rotating member112and the bent sleeve holder130positioned at3different example radial positions relative to the attachment pad102.

In an enhancement, the rotating member112and the bent sleeve holder130may be provided in a single-piece construction, preferably a single molded piece (e.g., single injection molded piece) made of a single, uniform material of construction, typically a polymeric material, having properties suitable to provide desired properties for functioning of both the flexible tabs134a,band the elastically deformable portion of the rotating member112. In some preferred implementations, such a material of construction for the rotating member112and the bent sleeve holder130has a hardness in a range of from 60 to 90 Shore A durometer.

A significant advantage in flexible utility of the securement device100is provided by the configuration permitting the bent sleeve holder130to be positioned at different radial positions relative to the attachment pad. The attachment pad may be positioned relative to a patient for best attachment of the securement device100to the patient without regard to the position of the bent sleeve holder130of the direction that a medical tube will project from the bent sleeve holder130. The bent sleeve holder130may be positioned at the most advantageous radial positioning relative to the patient's body regardless of the attachment orientation of the attachment pad102, for example to avoid unintended patient or medical personnel interactions with the medical tube120or the securement sleeve106or to keep the securement sleeve106and medical tube120positioned to avoid obstruction of areas on the patient to which medical access may be desired while the drainage tube120is secured to the securement device100. Additionally, the radial position of the bent sleeve holder130and medical tube120may be adjusted as desired based on patient experience or changing medical access needs. As will be appreciated, if the bent sleeve retainer is radially repositioned while the medical tube120is retained in the retaining channel132, the radial movement will tend to impart a torsional stress to the securement sleeve106and to the medical tube120gripped by the securement sleeve. As a consequence, it is preferred that prior to repositioning the radial position of the bent sleeve holder, the securement sleeve be removed from the retaining channel132, so that the bent sleeve retainer can be radially repositioned without imparting such a torsional stress to the securement sleeve106or medical tube120.

Reference is now made toFIG.16, together withFIGS.1-15, in relation to describing an absorbent feature of the securement device100to absorb exudate from a patient during use. As shown inFIG.16, the attachment pad102of the example securement device100includes an absorbent portion, in the form of an absorbent pad150, exposed on a proximal side152of the attachment pad102to provide absorbent capability to absorb exudate from a wound of a patient into which a secured medical tube extends during use of the securement device100. In the example illustrated inFIG.16, the absorbent pad150is attached, such as with adhesive, to a structural sheet154of the attachment pad102. The absorbent pad150has a proximal face156configured to contact and interface with skin of the patient during use of the securement device100. The absorbent pad150includes an aperture158, which forms a part of the tube passage116. The opening of the aperture158at the proximal face156of the absorbent pad150provides the proximal opening of the tube passage116in the example embodiment of the securement device100illustrated inFIGS.1-16. In an alternative variation, the securement device100may be in the absence of (may not include) the absorbent pad150, in which case an aperture of the structural sheet154would provide the proximal opening of the tube passage116. The structural sheet154may be made of any suitable material or materials that impart a desired structural integrity to the attachment pad102and that are suitably flexible to conform to topography of a patient's skin to which the attachment pad102is to be attached. As will be appreciated, it may be desirable at times to remove the securement device100from the patient without removing the medical tube from the patient, and then replace the removed securement device100with a new securement device, for example a new securement device100with a fresh absorption pad150. Some example materials of construction for the structural sheet include flexible plastic and fabric materials.

Also illustrated inFIG.16is the longitudinal axis118of the tube passage116, which for the portion of the tube passage116that extends through the attachment pad102is substantially perpendicular to a proximal face on the proximal side152of the attachment pad102adjacent a location where proximal end of the tube passage116is open on the proximal side152of the attachment pad102. In the illustrated example of the securement device100, the proximal end of the tube passage116opens through and is perpendicular to the proximal face156of the absorbent pad150. As will be appreciated, although the longitudinal axis118may bend through the securement sleeve106when the securement sleeve106is bent, such as illustrated in any ofFIGS.9-15, the longitudinal axis118will typically be in a substantially straight line for the portion of the tube passage116through the attachment pad102, even when the securement sleeve106is bent distal of the attachment pad102, such as illustrated inFIGS.9-15. As will also be appreciated, a medical tube (e.g., the medical tube120) exiting the body of a patient will typically enter the proximal end of the tube passage116substantially perpendicular to the skin of the patient in that vicinity.

Including the absorbent pad150in the example embodiment of the securement device100advantageously permits absorption of exudate migrating out of a wound of the patient into which the medical tube is inserted. Such absorption of exudate advantageously helps to maintain the area around the wound in a clean state and also helps to inhibit exudate from seeping between the structural sheet154and skin of the patient, which could loosen and adhesive bond between the attachment pad102and the skin of the patient. The attachment pad102may comprise absorbent material and may have a desired absorbent capacity, for example as disclosed elsewhere herein. The absorbent pad150may beneficially contain an antimicrobial agent. Examples of some possible antimicrobial agents for use with an absorbent portion of the attachment pad102or elsewhere in connection with a securement device or product or kit including a securement device, include polymyxin, bacitracin, mupirocin, silver, chlorhexidine gluconate and similar derivatives, or iodine and its derivatives. More generally, the attachment pad102may include an antimicrobial agent, which may include for example any of the example microbial agents described for the absorbent pad. Such an antimicrobial agent may be included in the absorbent pad, adhesive layer and/or another other layer or feature of the attachment pad102, and preferably when the attachment pad102includes an antimicrobial agent, the antimicrobial agent is contained in one or more portions of the attachment pad102that is open to fluid communication with the patient (e.g., the skin or wound of the patient) for contact or release of the antimicrobial agent to contact the patient (e.g., for the antimicrobial to contact the skin or wound of the patient).

In the embodiment of the securement device100as illustrated inFIG.16, a proximal surface of the structural sheet154completely surrounds a periphery of the absorbent pad150. In some preferred implementations of the securement device100, the proximal side152of the attachment pad102includes a layer of adhesive covering the portion of the proximal surface of the structural sheet154that surrounds the periphery of the absorbent pad150. Such an adhesive layer may thus be exposed on the proximal side152of the attachment pad and may advantageously be used to adhere the attachment pad102to the skin of the patient completely around the periphery of the absorbent pad150. The absorbent pad150may or may not include adhesive on the proximal surface156. In some preferred implementations, the proximal face156of the absorbent pad150is substantially in the absence of adhesive, which could otherwise interfere with effective absorption of exudate coming from an adjacent a wound. However, in some alternative implementations the attachment pad102may include adhesive over at least a portion of the proximal face156to adhere the adsorbent pad150to skin of the patient, however in such alternative implementations the adhesive preferably does not cover the entire proximal face156and a portion of the proximal face156is uncovered by adhesive to provide better fluid communication at those locations for exudate to permeate into the absorbent material of the absorbent pad150. For example such adhesive on the proximal face156may be in a perforated layer of adhesive, with areas of the perforations comprising a portion of the proximal face156being free of adhesive.FIG.17illustrates an example of a variation of an absorbent pad150′ on which a perforated layer of adhesive is disposed over a portion of the proximal face, through which areas of perforations157are free of adhesive to provide enhanced fluid communication through those areas. As will be appreciated, other configurations for adhesive on the proximal face156could be provided other than the perforated configuration illustrated inFIG.17, provided that adhesive coverage over the proximal face156is sufficient to provide a desired level of adherence of the proximal face156to skin of the patient while not unduly inhibiting fluid communication into absorbent material of the absorbent pad150.

The absorbent pad150can be sized to provide more or less absorbent material to alter the absorbent capacity of the absorbent pad150, for example through changes in the thickness of the absorbent pad or the areal proportion of the proximal side152of the attachment pad102that is provided by the proximal face156of the absorbent pad150. As will be appreciated, the more of the proximal side152that is made up by the proximal face156, the smaller will be the exposed proximal surface of the structural sheet154. In one alternative implementation, the proximal face156of the absorbent pad150can make up the entirety of the proximal side152of the attachment pad102, and in such an alternative implementation, the proximal face156may include adhesive exposed at a portion of the proximal face to adhere the attachment pad102to the patient while other portions of the proximal face are in the absence of adhesive, for example with a perforated adhesive pattern as illustrated inFIG.17or as may be provided with other adhesive patterns on the proximal face156. In an implementation where the proximal face156of the adhesive pad150makes up the entirety of the proximal side152of the attachment pad102, the attachment pad102may still include the structural sheet154adhered to a distal face of the absorbent pad150to enhance durability of the attachment pad102, to provide structural support to the absorbent pad150and/or to provide a protective cover over a distal side of the absorbent pad150. The structural sheet154may be made of any material, for example a polymeric material, used to make wound bandages.

Reference is now made toFIGS.18-20, together withFIGS.1-17, in relation to an example embodiment of a securement device including a compression retainer.FIGS.18-20show an example embodiment of a securement device100′, which has the same features and operational capabilities as the securement device100illustrated inFIGS.1-17, but with the securement device100′ also including a compression retainer160.FIG.18shows the compression retainer160disposed to retain the securement sleeve106in a compressed configuration with the cross-sectional area of the tube passage116in an enlarged configuration to receive insertion of a medical tube for positioning within the securement sleeve106.

FIG.18shows the securement device100′ attached to the skin124of a patient through the attachment pad102and with the medical tube120disposed through the securement device100′ and into the body of the patient. InFIG.19, the securement device100′ is illustrated with the compression retainer160disposed to retain the securement sleeve106in the compressed configuration ready to receive a medical tube for securement. In the compressed configuration as illustrated inFIGS.18, the securement portion122of the securement sleeve106and the medical tube120may be configured for example as illustrated inFIGS.5and6.

FIG.20shows the securement device100′ after the compression retainer160has been manipulated, through removal of the compression retainer160in the example embodiment ofFIGS.18-20, to release the securement sleeve106, and consequently also the securement portion122of the securement sleeve106, from the compressed configuration to permit the securement sleeve106to lengthen and with corresponding contraction of the cross-sectional area of the tube passage116in the securement portion122to grip the medical tube120in the tube passage116. When the compression retainer160has been removed, as illustrated inFIG.20, the securement portion122of the securement sleeve106and the medical tube120may be in a configuration, for example, as illustrated inFIGS.7and8. As will be appreciated, other configurations for a compression retainer are possible, for example in which the securement sleeve106could be released from the compressed configuration without removal of the compression retainer from other components of the securement sleeve100′. For example, a compression retainer could be pivotally-connected or slidably-connected to other components of the securement device100′ and being manipulable to release the securement sleeve106from the compressed configuration without disconnection of the compression retainer from the other assembled components of the securement device100′. However, complete disengagement and removal of the compression retainer160as illustrated inFIG.20is preferred, to remove complications and obstructions that may otherwise be present if the compression retainer160is not fully removed from other remaining components of the securement device100′.

As illustrated inFIGS.18and19, when the compression retainer160is disposed to retain the securement sleeve106, and the securement portion122, in a compressed configuration, the compression retainer160has retaining projections166and168that engage, respectively, a top surface162of the distal collar110and a securement recess164on the extension portion114of the base member108. The compression retainer160includes a handle tab170configured to be easily grasped by a medical practitioner to remove the compression retainer160to release the securement sleeve106from the compressed configuration.

As will be appreciated, if the securement device100′ is configured as shown in FIG. with the compression retainer160disengaged from the top surface162of the distal collar110and the securement recess164of the extension portion114of the base member108, the distal collar110may be pushed toward the extension portion114to compress the securement sleeve106to the compressed configuration, and while holding the securement sleeve106in the compressed configuration the compression retainer160may be placed in position to engage the top surface162and the securement recess164to hold the securement sleeve106in the compressed configuration, for example to permit convenient repositioning or replacement of the medical tube120or removal and replacement of the securement device100without removal of the medical tube120. As will also be appreciated, the securement device100′ may be initially provided in a product form with the compression retainer160preinstalled to retain the securement sleeve106in the compressed configuration until the securement device100′ is used to secure a medical tube. Alternatively, the securement device100′ may be initially provided in a product form with the compression retainer160not preinstalled to retain the securement sleeve106in the compressed configuration, and the compression retainer160may be installed as needed to hold the securement sleeve106in the compressed configuration while the medical tube is inserted into the securement sleeve106for positioning prior to gripping the medical tube with the securement portion122of the securement sleeve106. Providing the securement device100′ in a product form with the compression retainer160preinstalled provides the benefit of not having to install the compression retainer160prior to insertion of a medical tube into the securement portion122of the securement sleeve106. However, providing the securement device100′ in a product form with the compression retainer160not preinstalled to retain the securement sleeve106and the compressed configuration may provide a benefit of a longer shelf-life of the securement device100′ by not losing expansive capability of the securement sleeve106over long periods of storage with the securement sleeve held in a compressed configuration.

After use of a securement device, such as the securement device100, is complete the securement device may be detached from the patient. Detachment may include application of an alcohol or other solvent around the edges of the attachment pad, such as with a swab or wipe, to degrade adhesive, permitting the adhesive pad to be more easily peeled away from the patient's skin. As portions of the attachment pad are peeled away from the skin, the solvent may continue to be applied around adhered areas of the attachment pad until all adhered portions of the attachment pad have been detached from the skin. Prior to detachment of the securement device, the securement sleeve may be manipulated to release the medical tube from securement and the medical tube removed from the patient and the securement sleeve. Alternatively, the securement device and the secured medical tube may be removed as a unit, with the medical tube gripped by the securement portion of the securement sleeve while the securement device is detached from the patient, and the proximal end of the medical tube may then be pulled out of the patient as the securement device is removed. When the medical tube remains secured to the securement device while the securement device is detached from a patient, the medical tube may or may not be retained in the bent configuration by a bent sleeve holder of the securement device. Retaining the medical tube in the bent configuration helps to prevent movement of the medical tube relative to the securement device as the securement device is detached. Alternatively, the medical tube may be released from the bent configuration prior to detachment of the securement device.

Reference is now made toFIGS.21-32, together withFIGS.1-17, in relation to further describing features of the example securement device100and an example method of making the example securement device100.

FIG.21shows components and their relative positioning for a coupling structure between the securement sleeve106and the structural sheet154for the attachment pad102for the securement device100ofFIG.1. As shown inFIG.21, the securement sleeve106is disposed through an aperture through the base member108and with a proximal end portion180of the securement sleeve106disposed between a proximal side of the base member108and a distal side of the structural sheet154. Disposed on the distal side of the structural sheet154is an adhesive layer182of pressure-sensitive adhesive. As will be appreciated, adhesive can also or alternatively be provided on the distal side of the structural sheet154.

FIGS.22-26illustrate processing to couple together the base member108, securement sleeve106and structural sheet154.FIG.22illustrates the securement sleeve106disposed through the aperture of the base member108and with a flaring tool184inserted into a proximal end of the securement sleeve106to flare the proximal end portion180of the securement sleeve106.FIG.23shows a compression ring tool186disposed over a mandrel portion at the top of the flaring tool184and with the compression ring tool186being advanced over the mandrel portion to press a distal side of the structural sheet154toward the proximal face of the base member108with the proximal end portion180of the securement sleeve106disposed between the proximal face of the base member108and the distal side of the structural sheet154. As the compression ring tool186is advanced along the mandrel portion of the flaring tool184to advance the structural sheet154toward the base member108, the distal side of the structural sheet154engages the proximal end portion180of the securement sleeve106and continues to flare the proximal end portion180to a 90° flare angle with the proximal end portion180flattened between the proximal face of the base member108and the distal side of the structural sheet154and in contact with the pressure sensitive adhesive of the adhesive layer182(not shown inFIG.23, shown inFIG.21).FIG.24shows the compression ring tool186fully advanced, and in the configuration shown inFIG.24the compression ring tool186is pressed toward the base member108with sufficient force to adhere the proximal face of the base member108to the distal side of the structural sheet154with the pressure sensitive adhesive, and with the flared proximal end portion180of the securement sleeve106sandwiched between the proximal face of the base member108and the distal side of the structural sheet154and held by the adhesive.FIGS.25and26show a resulting first preliminary product form188including the base member108, securement sleeve106and structural sheet154after removal of the compression ring tool186and the flaring tool184.

FIGS.27-29illustrate processing to attach the rotating member112, including the bent sleeve holder130, to the preliminary product form188shown inFIGS.25and26. As shown inFIGS.27and28, with the securement sleeve106disposed through an aperture of the rotating member112with a proximal face of the rotating member112facing a distal side of the base member108, the rotating member112is advanced along the securement sleeve106toward the extension portion114of the base member108.FIG.27shows the extension portion114of the base member108as including a first lip ring190and a second lip ring192and with the securement recess164being between the first lip ring190and the second lip ring192. The extension portion114also includes a circular groove track194between the second lip ring192and a flange surface196of the base member108. The rotating member112is advanced over the securement sleeve106and over the extension portion114of the base member108until the rotating member112is engaged in the circular groove track194. The rotating member112is made of a suitably flexible material to permit the material at the perimeter of the aperture to deflect over the first circular lip190and over the second circular lip192and then snap into place in the circular groove track194with the rotating member112being rotatably retained in the circular groove track194and rotatable about the extension portion114of the base member108. As shown inFIG.28, as the rotating member112is advanced to engage the extension portion114, the projections144may be aligned with corresponding recesses142to position the engaged rotating member112at a desired radial position relative to the base member108.FIG.29shows an assembled second preliminary product form200including the added rotating member112.

FIGS.30-33illustrate processing to add the distal collar110at the distal end of the securement sleeve106of the second preliminary product form200. A collar assembly of the distal collar110includes a collar member202with a collar nipple204and a retaining member206.FIG.30illustrates the securement sleeve106disposed through an opening through the retaining member206and the collar member202positioned for engagement with a distal end portion210of the securement sleeve106using an insertion tool212.FIG.31shows a leading end of the insertion tool212inserted into the distal end portion210of the securement sleeve106andFIG.32shows the insertion tool212fully advanced into the distal end portion210of the securement sleeve106with the distal end of the securement sleeve106contacting a stop collar214of the insertion tool212. The retaining member206is then advanced over the distal end portion210of the securement sleeve106to bias a sleeve wall of the distal end portion210against the collar nipple204. The retaining member206is advanced until a distal end of the retaining member206is adjacent, and preferably contacting, a distal collar portion216of the collar member202. The assembled collar member202and the retaining member206holding the distal end portion210form the distal collar110, which is illustrated in a resulting third preliminary product form220inFIG.33.

Reference is now made toFIG.34illustrating processing to add the absorbent pad150to the third preliminary product form220to complete the attachment pad102and prepare the securement device100ofFIG.1.FIG.34also shows adding a peelable backing over a proximal side152of the attachment pad102to prepare a medical drain securement product including the securement device and the peelable backing.FIG.34shows a layer of pressure-sensitive adhesive222that is applied to a proximal side of the structural sheet154of the third preliminary product form, and the absorbent pad150is attached to the proximal side of the structural sheet154using a portion of the adhesive layer222and with the aperture158of the absorbent pad150aligned with an aperture224of the adhesive layer222and with a corresponding aperture of the structural sheet154. As shown inFIG.34, the structural sheet154, adhesive layer222and absorbent pad150make up the attachment pad102when assembled. The adhesive layer222may contain an antimicrobial agent, similar to the discussion of a possible antimicrobial agent for the absorbent pad150. The aligned apertures through the absorbent pad150, adhesive layer222and structural sheet154form the portion of the tube passage116that is through the attachment pad102. As illustrated inFIG.34, addition of the attachment pad102to the third preliminary product form220forms the securement device100ofFIG.1.

Also shown inFIG.34is application of a peelable backing over the proximal side152(shown inFIG.16) of the attachment pad102, with the peelable backing being adhered to the attachment pad102through the adhesive layer222to form a medical tube securement product240. In the illustrated example inFIG.34, the peelable backing is made of two flexible backing pieces228a,badhered to the adhesive layer222around the absorbent pad150and covering the absorbent pad150. The flexible backing pieces228a,bhave peeling tabs230a,bwhich a person may grab and pull apart to remove the peelable backing sheets228a,bfrom the attachment pad102to expose the absorbent pad150and the adhesive layer222around the periphery of the absorbent pad150, for example to permit the proximal side152of the attachment pad to be adhered to skin of a patient during use of the securement device100.

As will be appreciated, the securement device100′ including the engaged compression retainer160as illustrated inFIGS.18and19may be made from the securement device100illustrated inFIG.34by compressing the securement sleeve106to the compressed configuration and positioning the compression retainer160to engage the distal collar110and the extension portion114of the base member108to retain the securement sleeve106in the compressed configuration as illustrated inFIGS.18and19. Thus, the medical tube securement product240may be prepared to include the securement device100′ by inclusion of the compression retainer160. The compression retainer160may be included preinstalled to retain the securement sleeve106in the compressed configuration or the compression retainer160may be included but not preinstalled in such a manner, for example as a separate piece that may be installed by a medical practitioner to hold the securement sleeve106in the compressed configuration as desired.

Reference is now made toFIG.35showing an example kit300including a medical tube securement product302. The medical tube securement product302includes a medical tube securement device304disposed in a hermetically-sealed enclosure306. The medical tube securement device304can for example be, or include any features of, the example securement device100or the example securement device100′ illustrated or described in relation to any ofFIGS.1-34, the example securement device350illustrated or described in relation to any ofFIGS.36-38, or the example securement device100″ or example securement device100′″ illustrated or described in relation to any ofFIGS.39-51. The medical tube securement device304can for example be in the form of, or have any features of, the medical tube securement product including such a securement device, with or without a compression retainer and including a peelable backing, for example as illustrated for the medical tube securement product240illustrated inFIG.34. The medical tube securement device304is preferably sterile in the hermetically-sealed enclosure306. Sterilization of the securement device304may be accomplished before or after sealing the securement device304in the hermetically-sealed enclosure306. In one preferred method, the medical tube securement device is sterilized after being sealed in the hermetically-sealed enclosure306by exposure to radiation that penetrates the enclosure306and sterilizes the medical tube securement device in the enclosure306. The hermetically-sealed enclosure306may for example be made of a polymeric material of a type used to package medical devices. The kit300is illustrated as containing only a single medical tube securement product302, but in alternative variations such a kit can include a plurality of any number of such medical tube securement products302.

With continued reference toFIG.35, the kit300includes at least one additional component308a, but may include a plurality of additional components, illustrated inFIG.35as including optional additional components308band308c, although it will be appreciated that the kit may include any number of additional components, which may be in excess of three. Examples of product types for the additional component308ainclude a medical tube or any other of the product types disclosed herein for an additional product in a kit. When a plurality of additional components are included in the kit300, each one of the additional components may be the same type of product, or different ones of the additional components may be different types of products.

Reference is now made toFIGS.36-38in relation to another example of a medical tube securement device with capability to selectively retain a medical tube in a bent configuration.FIGS.36-38illustrate an example medical tube securement device350including a securement sleeve352with a securement portion made of a braided textile construction. The securement portion can for example be or have properties as described previously with reference to any ofFIGS.1-20. The securement device350includes a base structure including an attachment pad354, a base member356, a retaining member358and a movable bale member360. The securement device350also includes a distal collar362. The securement sleeve352has a proximal end retained in the base structure and a distal end retained in the distal collar362. The securement sleeve352, the securement portion of the securement sleeve352, the attachment pad354, the base member356and the distal collar362can have features the same as or similar to those described previously for corresponding features illustrated in any ofFIGS.1-34. For illustration purposes, the securement device350is shown with a medical tube364disposed through the tube passage through the medical device350and secured to the medical device350by the securement portion of the securement sleeve352.

The securement device350includes a bent sleeve holder provided by cooperating features of the retaining member358and the bale member360. The bale member360is movable between a first configuration in which the securement sleeve352is not retained in a bent configuration, as illustrated inFIG.36, and a second configuration in which the securement sleeve352is retained in a bent configuration, as illustrated inFIGS.37and38. When the bale member360is moved from the first configuration as shown inFIG.36to the second configuration as shown inFIGS.37and38, the bale member360contacts the securement sleeve352and biases the securement sleeve352into the bent configuration. The retaining member358includes a lock feature in the form of a depressible tab370with a lip projection that locks the bale member360in place when the bale member360is positioned into the second configuration. The bale member360may be released from the second configuration by depressing the tab370sufficiently to permit the bale member360to be moved over the lip projection and returned to the first configuration, and with a corresponding release of the securement sleeve352from the bent configuration.

In the illustrated example of the securement sleeve ofFIGS.36-38, the retaining member358is fixed in position relative to the base member356and the attachment pad358. However in an alternative implementation the retaining member358may be rotatably mounted in the base structure so that the retaining member358may be rotatable to different radial positions relative to the base member356and the attachment pad358, to permit the securement sleeve352in the bent configuration to be bent in different radial directions relative to a longitudinal axis of the tube passage through the attachment pad352and the base member356, similar to that operation of the rotating member112illustrated in the securement device100ofFIGS.1-16,18-20and34.

Reference is now made toFIGS.39-42illustrating another embodiment of a medical tube securement device100″, which has similar features to the securement device100ofFIGS.1-16, and reference numerals identifying features of the securement device100″ are the same as those used1-16to identify like features, whereas similar but modified alternative features are identified by a like reference number with an added apostrophe at the end. In contrast to the securement device100ofFIGS.1-16, the securement device100″ illustrated inFIGS.39-42includes alternative configurations for a distal collar110′, rotating member112′ and bent sleeve holder130′.

As shown inFIGS.39-42, the bent sleeve holder130′ includes a retaining channel132′ that is open facing the distal side104of the attachment pad102to receive a portion of the securement sleeve106to retain the securement sleeve106in a bent configuration in which a distal portion of the securement sleeve106is biased toward the skin of a patient when the attachment pad102is secured to the skin. The retaining channel132′ is mechanically reinforced with reinforcing ribs402that help to stabilize and reduce potential for twisting or bending of the retaining channel132′ during use. On a side of the retaining channel132′ opposite the reinforcing ribs402, a wall of the retaining channel132′ includes an open side portion404that facilitates movement of the bent securement sleeve106into and out of the retaining channel132′.

Similar to the securement device100illustrated inFIGS.1-16, the securement device100″ includes the bent sleeve holder130′ supported by the rotating member112′. The rotating member112′ is similar to the rotating member112of the securement device100illustrated inFIGS.1-16, except with a somewhat modified design for a manipulation tab146′ and with five projections144′ (shown inFIG.40) rather than three corresponding projections as illustrated inFIGS.1-16. As with the securement device100illustrated inFIGS.1-16, the rotating member112′ is rotatable to different radial positions relative to the base member108. The base member108in the securement device100″ has the same configuration as illustrated for the securement device100ofFIGS.1-16, with recesses (not shown inFIGS.39-42) in the base member108configured to receive the projections144′ to lock the rotating member112′ at different radial positions. The manipulation tab146′ is deformable in the same manner as described for the manipulation tab146ofFIGS.1-16, permitting a user to elastically deform a portion of the rotating member112′ to engage and disengage the projections144′ with the corresponding recesses in the base member108.FIGS.41and42illustrate the securement device100′ with the securement sleeve106received in the retaining channel132′ of the bent sleeve holder130′ and with the rotatable member112′ locked at different radial positions relative to the base member108.

The alternative design of the bent sleeve holder130′ has been found to provide enhanced retainment of the securement sleeve106in the bent configuration and to be less susceptible to the securement sleeve106being inadvertently dislodged from the bent sleeve holder during use.

The alternative distal collar110′ of the securement device100″ ofFIGS.39-42is constructed with a waterfall design to retain a distal end of the securement sleeve106, features of which will be better appreciated with reference toFIGS.43-49.

Manufacture of the securement device100″ is similar to the method illustrated in and described with reference toFIGS.21-34, except for modified processing for assembling the modified distal collar110′ of the securement device100″. Reference is now made toFIGS.43-49illustrating assembly of the distal collar110′ during manufacture of the securement device100″.FIG.43shows a second preliminary product form200′ with an intermediate assembly of the structural sheet154, base member108, rotating member112′, securement sleeve106and bent sleeve holder130′, and with the rotating member112′ held by and rotatable about the extension portion114of the base member108, similar to the second preliminary product form200illustrated inFIG.29during manufacture of the securement device100ofFIGS.1-16.

FIG.43shows a waterfall collar410disposed over the securement sleeve106of the second preliminary product form200′ during assembly of the distal collar110′ of the securement device100″ ofFIGS.39-42. As illustrated inFIG.43, a leading edge of a flaring tool412is inserted into the distal end portion210of the securement sleeve106. The flaring tool412is advanced into the securement sleeve106to flare the distal end portion210of the securement sleeve106as illustrated in the sequential processing illustrated inFIGS.44and45. After the distal end portion210of the securement sleeve106has been flared open as shown inFIG.45by full advancement of the flaring tool412, then the waterfall collar410is positioned adjacent the flared distal end portion210of the securement sleeve106and a waterfall sleeve414is advanced over the flaring tool412to engage the flared distal end portion210of the securement sleeve106, as illustrated inFIG.45. As the waterfall sleeve414is further advanced over the waterfall collar410, as illustrated inFIG.46, the flared distal end portion210of the securement sleeve106is folded over the securement collar410in a waterfall configuration around the exterior of the waterfall collar410, and the waterfall sleeve414is advanced over the waterfall collar410, and over the folded portion of the distal end portion210of the securement collar410, until the advancing end of the waterfall sleeve414is adjacent a bottom lip portion of the waterfall collar410, and the flaring tool412is then removed from the securement sleeve106, as illustrated inFIG.47. As illustrated inFIG.48, a waterfall retainer416is then disposed over the waterfall sleeve and engaged with and connected to the waterfall collar410to form the final assembled distal collar110′ for the securement device100″. The finished configuration of the distal collar110′ is illustrated in the partial sectional view ofFIG.49, showing the flared distal end portion210of the securement sleeve106folded over and disposed between the waterfall collar410and the waterfall sleeve414and with the waterfall retainer416engaged with the waterfall collar. Completion of manufacture of the securement device100″ may then proceed with the addition of the absorbent pad150, similar to as illustrated inFIG.34, and a securement product may be formed by adding a peelable backing, for example as provided by the peelable backing sheets228a,bsimilar to the illustration inFIG.34.

The securement device100″ may also be combined with a compression retainer, similar to the configuration of the securement device100′ illustrated inFIG.18-20. With reference toFIG.50, together withFIGS.39-49, a securement device100—is illustrated, in which a compression retainer160′ is engaged with the distal collar110′ and the extension portion114of the rotating member112′ to retain the securement sleeve106in a compressed configuration with the cross-sectional area of the tube passage116through the securement sleeve106in an enlarged configuration to receive insertion of a medical tube for positioning within the securement sleeve106. The compression retainer160′ is similar in design to the compression retainer160ofFIGS.18-20, but includes a keyhole cutout in the top to snap around a correspondingly shaped top projection on the distal collar110′ to more securely hold the securement sleeve in the compressed configuration for application of the securement device100′″ to a patient during a medical procedure. InFIG.50, the securement device100′″ is illustrated with the medical tube120disposed through the securement sleeve106in the compressed configuration.FIG.51shows the securement device100—after disengagement of the compression retainer160′, permitting the securement sleeve to lengthen and grip the medical tube120for securement of the medical tube120to the securement sleeve106.

Exemplary Implementation Combinations.

Some other contemplated embodiments of implementation combinations for various aspects of this disclosure, with or without additional features as disclosed above or elsewhere herein, are summarized in the numbered paragraphs presented below, and in the appended claims:

1. In some embodiments, a securement device is provided to secure to a patient a medical tube when inserted into the patient, the securement device comprising:an attachment pad configured to interface with skin of a patient for attachment of the securement device to the skin, and preferably the attachment pad has an adhesive surface to adhere the attachment pad to a surface of the skin;a variable-length securement sleeve having a proximal end and a distal end at a longitudinal end opposite the proximal end, the securement sleeve being coupled to the attachment pad through a coupling structure adjacent the proximal end of the securement sleeve;a tube passage configured to receive therethrough a medical tube for securement to a patient, the tube passage extending longitudinally through the securement sleeve; andthe securement sleeve including a securement portion through which the tube passage extends, wherein a cross-sectional area of the tube passage in the securement portion transverse to a longitudinal path of the tube passage expands as the securement sleeve is shortened and contracts as the securement sleeve is lengthened and the length of the securement sleeve is adjustable to expand the cross-sectional area to receive the medical tube for translation through the tube passage in the securement portion and to contract the cross-sectional area to grip the medical tube in the tube passage by the securement portion to secure the medical tube to the securement device.
Bent Sleeve Retainer

2. The securement device of paragraph 1, comprising a bent sleeve holder selectively engageable and disengageable with the securement sleeve to selectively retain and not retain the securement sleeve in a bent configuration in which the securement sleeve has a bend in which the tube passage is correspondingly bent, and preferably in the bent configuration the bend biases a portion of the sleeve distal of the bend toward the attachment pad.

3. The securement device of paragraph 2, wherein in the bent configuration the securement sleeve is bent by an angle of at least 60°, preferably at least 80° and more preferably at least 90° between the distal end and the proximal end of the securement sleeve.

4. The securement device of either one of paragraph 2 or paragraph 3, wherein in the bent configuration, at least a longitudinal portion of the securement portion of the securement sleeve is bent.

5. The securement device of any one of paragraphs 2-4, wherein the bent sleeve holder engages at least a longitudinal portion of the securement portion of the securement sleeve when the securement sleeve is engaged with the bent sleeve holder to retain the securement sleeve in the bent configuration.

6. The securement device of any one of paragraphs 2-5, wherein the bent sleeve holder comprises a movable member that is movable between a first configuration in which the securement member is not retained in the bent configuration and a second configuration in which the movable member contacts and biases the securement sleeve in the bent configuration.

7. The securement device of paragraph 6, comprising a lock configured to retain the movable member in the second configuration when the movable member is repositioned from the first configuration to the second configuration.

8. The securement device of paragraph 7, wherein the lock is selectively releasable to permit repositioning of the movable member from the second configuration to the first configuration.

9. The securement device of any one of paragraphs 2-5, wherein the bent sleeve holder comprises a retaining channel into which a corresponding portion of the securement sleeve is receivable in a received position to retain the securement sleeve in the bent configuration.

10. The securement device of paragraph 9, wherein the bent sleeve holder comprises flexible tabs that flex when the corresponding portion of the securement sleeve is inserted into the channel to be received in the channel in the received position to retain the securement sleeve in the bent configuration and when the corresponding portion of the securement sleeve is removed from the channel to release the securement sleeve from the bent configuration.

11. The securement device of paragraphs 10, wherein the flexible tabs, and optionally the entire bent sleeve holder, are made of a polymeric material of construction, preferably a thermoplastic elastomer, and optionally selected from the group consisting of thermoplastic polyurethanes, thermoplastic vulcanizates and combinations thereof.

12. The securement device of either one of paragraph 10 or paragraph 11, wherein the flexible tabs, and optionally the entire bent sleeve holder, are made of a material of construction having a hardness in a range of from 60 to 90 Shore A durometer.

13. The securement device of either one of paragraph 11 or paragraph 12, wherein the bent sleeve holder comprises a channel member comprising the flexible tab portions, and the channel member is made of the material of construction.

13.1 The securement device of any one of paragraphs 9-13, wherein the retaining channel is open facing away from the attachment pad.

13.2 The securement device of any one of paragraphs 9-13, wherein retaining channel is open facing toward the attachment pad.

14. The securement device of any one of paragraphs 2-13.2, wherein the bent sleeve holder is rotationally mounted and rotatable to different radial positions relative to the attachment pad, preferably with the bent sleeve holder maintaining a constant standoff from the attachment pad at all said radial positions; and optionally the different radial positions are radially spaced with a radial spacing of no more than 30 degrees, preferably no more than 15 degrees, and optionally of at least 5 degrees, and preferably the proximal end of the securement sleeve is in a fixed position relative to the attachment pad and rotation of the bent sleeve holder relative to the attachment pad also rotates the bent sleeve holder relative to the securement sleeve.

15. The securement device of paragraph 14, wherein the radial positions are radially spaced about a longitudinal axis of the tube passage through the attachment pad.

16. The securement device of either one of paragraph 14 or paragraph 15 wherein the attachment pad has a proximal side to be disposed facing the skin of a patient during use and the radial positions are radially spaced about an axis perpendicular to a face of the proximal side of the attachment pad.

17. The securement device of any one of paragraphs 14-16, comprising a radial positioning lock to selectively lock the bent sleeve holder at different ones of the radial positions.

18. The securement device of any one of paragraphs 14-17, wherein the bent sleeve holder is rotatable by at least 90 degrees about an axis of rotation, preferably at least 180 degrees and more preferably at least 360 degrees.

19. The securement device of any one of paragraphs 14-18, comprising a base member and a rotating member that is rotatable relative to the base member, and wherein the bent sleeve holder is supported on the rotating member, and preferably the base member has a fixed orientation relative to the attachment pad, wherein rotation of the rotating member relative to the base member results in rotation of the rotating member also relative to the attachment pad.

20. The securement device of paragraph 19, wherein:the base member and the rotating member comprise corresponding interlocking first and second lock structures that are selectively engageable to lock the radial position of the rotating member at different ones of the radial positions.

21. The securement device of paragraph 20, wherein the rotating member has at least a portion that is elastically deformable to disengage the first and second lock structures and to permit repositioning of the bent sleeve holder between different said radial positions.

22. The securement device of any one of paragraphs 19-21, wherein the rotating member, and optionally the base member, is made of a polymeric material of construction, preferably a thermoplastic elastomer, and optionally selected from the group consisting of thermoplastic polyurethanes, thermoplastic vulcanizates and combinations thereof, and wherein both the rotating member and the base member are made of a said polymeric material of construction, the properties (e.g., hardness) of each said polymeric material of construction of the rotating member and the base member can be the same or different.

23. The securement device of paragraph 22, wherein the rotating member, and optionally the base member, is made of a material of construction having a hardness in a range of from 60 to 90 Shore A durometer.

24. The securement device of any one of paragraphs 19-23, wherein the bent sleeve holder and the rotating member are in a single molded piece, preferably a single injection molded piece, and preferably the single molded piece is made of a single material of construction.

25. The securement device of any one of paragraphs 19-24, wherein the base member comprises an extension portion extending through an aperture in the rotating member, and the rotating member is rotatable about the extension portion, and optionally the rotating member is retained in and rotatable relative to a circular groove track extending around a perimeter of the extension portion.

26. The securement device of any one of paragraphs 19-24, wherein the base member is a molded piece, preferably an injection molded piece, and optionally the molded piece of the base member is made of a single material of construction.

27. The securement device of any one of paragraphs 2-26, wherein:the bent sleeve holder is configured to retain the securement sleeve in the bent configuration with the entire length of the tube passage in the securement sleeve disposed within a standoff distance from a proximal surface plane of the attachment pad;a minimum insertion cross-section of the tube passage in the securement portion, transverse to a longitudinal path of the tube passage through the securement portion, varies in size as the length of the securement sleeve is varied, the minimum insertion cross-section having a maximum cross-dimension (e.g., diameter in preferred implementations when the minimum insertion cross-section is circular) that correspondingly varies as the size of the minimum insertion cross-section is varied;the standoff distance is not greater than 10 times, preferably not greater than 7 times and more preferably not greater than 6 times, a relaxed-state maximum cross-dimension of the minimum insertion cross-section of the tube passage through the securement sleeve, and optionally is preferably at least 3 times or even at least 4 times the relaxed-state maximum cross-dimension; andthe relaxed-state maximum cross-dimension is the maximum cross-dimension of the minimum insertion cross-section when the securement sleeve is in a relaxed state not under longitudinally-applied compression or tension. As will be appreciated, the relaxed-state maximum cross dimension will typically not correspond to the bent configuration. As will be appreciated, such relaxed-state maximum cross-dimension will typically be slightly smaller than a maximum outer cross-dimension (e.g., diameter) of an outer cross-section of a portion of the medical tube that the securement sleeve is designed to receive for securement in the securement portion. In one example, such a standoff distance for a sleeve designed to retain a 5 millimeter diameter medical tube can preferably be about 24 millimeters.
Compression Retainer

28. The securement device of any one of paragraphs 1-27, comprising a compression retainer disposed to retain the securement sleeve in a compressed configuration with the securement portion of the securement sleeve under longitudinally-applied compression with the cross-sectional area in an expanded configuration to receive therethrough the medical tube.

29. The securement device of paragraph 28, wherein the compression retainer is manipulable to release the securement portion from the longitudinally-applied compression to lengthen the securement sleeve and to contract the cross-sectional area relative to the expanded configuration, to permit the securement portion to grip a said medical tube when disposed through the tube passage through the securement portion.

30. The securement device of paragraph 29, wherein the compression retainer is removable to release the securement portion from the longitudinally-applied compression and permit the securement sleeve to lengthen and the cross-sectional area to contract relative to the compressed configuration.

31. The securement device of any one of paragraphs 28-30, comprising a distal collar adjacent the distal end of the securement sleeve and a base structure adjacent a proximal end of the securement sleeve, and wherein the compression retainer engages the distal collar and the base structure to retain the securement sleeve in the compressed configuration.

32. The securement device of any one of paragraphs 28-31, comprising the rotating member and the base member according to any one of paragraphs 19-26, and wherein:the base structure comprises the base member and the base member comprises the extension portion of paragraph 25 extending through the aperture in the rotating member with the rotating member rotatable about the extension portion; andthe compression retainer engages the extension portion when the securement sleeve is in the compressed configuration.

33. The securement device of any one of paragraphs 28-32, wherein when the securement sleeve is in the compressed configuration the tube passage through the securement sleeve, and preferably all of the tube passage through the securement device, is maintained in a straight longitudinal configuration.

34. The securement device of paragraph 33, wherein when the compression retainer is manipulated to release the securement sleeve from the compressed configuration, the tube passage is released from the straight longitudinal configuration and the securement sleeve becomes amenable to being bent to produce a corresponding bend in the tube passage to bend a said medical tube when disposed through the tube passage.

35. The securement device of any one of paragraphs 28-34, wherein:the securement sleeve has a released configuration when the securement sleeve is released from the compression configuration with nothing disposed in the tube passage through the securement sleeve, the length of the securement sleeve being larger in the released configuration than in the compressed configuration; anda minimum insertion cross-section of the tube passage in the securement portion, transverse to a longitudinal path of the tube passage through the securement portion, varies as the length of the securement sleeve is varied, wherein the minimum insertion cross-section is larger in the compressed configuration than in the released configuration.

36. The securement device of paragraph 35, wherein:in the compressed configuration the minimum insertion cross-section is at least 10 percent larger than in the released configuration.

37. The securement device of either one of paragraph 35 or paragraph 36, wherein:the minimum insertion cross-section has a maximum cross-dimension, and preferably the minimum insertion cross-section is circular and the maximum cross-dimension is a diameter of the circular minimum insertion cross-section; andin the released configuration, the maximum cross-dimension of the minimum insertion cross-section in the released configuration is at least 0.5 millimeter smaller than, preferably at least 1.0 millimeter smaller than, and more preferably at least 1.5 millimeters smaller than, in the compressed configuration, and optionally is not more than 4 millimeters smaller than, and alternatively optionally not more than 3 millimeters smaller than, in the compressed configuration;optionally, the maximum cross-dimension of the minimum insertion cross section is in a range of from 2.5 to 26 millimeters when the securement sleeve is in the compressed configuration.

38. The securement device of any one of paragraphs 35-37, wherein:the minimum insertion cross-section has a maximum cross-dimension, and preferably the minimum insertion cross-section is circular and the maximum cross-dimension is a diameter of the circular minimum insertion cross-section;the minimum insertion cross-section is configured to receive in the compressed configuration and retain in the released configuration a corresponding outer cross-section of a medical tube, the outer cross-section having a maximum outer cross-dimension (e.g., outer diameter of a preferred medical tube with a circular outer cross-section);in the released configuration, the maximum cross-dimension of the minimum insertion cross-section is at least 0.5 millimeter smaller than, preferably at least 1.0 millimeter smaller than, and more preferably at least 1.5 millimeter smaller than, the maximum outer cross-dimension of the outer cross-section of the medical tube, and optionally not more than 4 millimeters smaller than, or alternatively optionally not more than 3 millimeters smaller than, the maximum outer cross-dimension of the outer cross-section of the medical tube.
Proximal Sleeve Coupling

39. The securement device of any one of paragraphs 1-38, wherein the coupling of the securement sleeve to the attachment pad comprises flared proximal end material of the securement sleeve sandwiched between a first securement member and a second securement member, optionally with the flared proximal end material of the securement sleeve flared at an angle of at least 75 degrees, and preferably at least 90 degrees, relative to an adjacent unflared portion of the securement sleeve, and preferably the flared proximal end material of the securement sleeve is sandwiched between opposing surfaces, preferably opposing parallel surfaces, of the first securement member and the second securement member.

40. The securement device of paragraph 39, wherein the flared proximal end material of the securement sleeve is adhered to at least one, and preferably both, of the first securement member and the second securement member, optionally by adhesive disposed between the first securement member and the second securement member.

41. The securement device of paragraph 40, comprising the adhesive disposed between the first securement member and the second securement member, and wherein the adhesive is a pressure-sensitive adhesive, and optionally the pressure-sensitive adhesive is selected from the group consisting of acrylic adhesives, silicone adhesives and combinations thereof.

42. The securement device of either one of paragraph 40 or paragraph 41, wherein the adhesive comprises;an adhesive layer applied to at least one surface selected from the group consisting of the first surface of the first securement member and the second surface of the second securement member, and preferably the adhesive layer comprises pressure sensitive adhesive; andoptionally the adhesive comprises:a first adhesive layer on a first surface of the first securement member and disposed toward the flared end material of the securement sleeve;a second adhesive layer on a second surface of the second securement member facing; andwherein the first adhesive layer and second adhesive layer are optionally of the same adhesive composition and alternatively optionally are of different adhesive compositions, and preferably each of the first and second adhesive layers comprise pressure-sensitive adhesive.

43. The securement device of any one of paragraphs 39-42, wherein the first securement member is the attachment pad.

44. The securement device of any one of paragraphs 39-43, wherein the second securement member is the base member of any one of paragraphs 19-26.

Distal Collar Assembly

45. The securement device of any one of paragraphs 1-44, wherein a distal end portion of the securement sleeve is retained by a distal collar assembly.

46. The securement device of paragraph 45, wherein the distal collar assembly comprises a collar member with a collar nipple disposed inside the distal end portion of the securement sleeve and a retaining member disposed over the distal end portion of the securement sleeve biasing a sleeve wall of the distal end portion toward the collar nipple.

46.1 The securement device of paragraph 45, wherein the distal collar assembly comprises a waterfall securement configuration.

46.2 The securement device of paragraph 46.1, wherein the distal collar assembly comprises a waterfall collar through which a portion of the securement sleeve is disposed and with a flared distal end portion of the securement sleeve folded over an exterior of the waterfall collar.

46.3 The securement device of paragraph 46.2, wherein the distal collar assembly comprises a waterfall sleeve disposed over at least a portion of the waterfall collar with the flared distal end portion of the securement sleeve folded over the exterior or the waterfall collar disposed between the waterfall collar and the waterfall sleeve.

46.4 The securement device of paragraph 46.3, wherein the distal collar assembly comprises a waterfall retainer disposed over the waterfall sleeve and engaged with the waterfall collar.

47. The securement device of any one of paragraphs 45-46.4, comprising the compression retainer of any one of paragraphs 28-38 retaining the securement sleeve in the compressed configuration with the compression retainer engaging the distal collar assembly.

Attachment Pad and Absorbent Portion

48. The securement device of any one of paragraphs 1-47, wherein the attachment pad comprises an absorbent portion configured to absorb exudate during use of the securement device;optionally the attachment pad comprises a structural sheet and a distal side of the absorbent portion, to be disposed away from a patient during use of the securement device, is covered by the structural sheet, and further optionally the attachment pad comprises adhesive over at least a portion of a proximal side of the structural sheet for adherence of the attachment pad to the skin of a patient.

49. The securement device of paragraph 48, wherein the tube passage extends through an aperture in the absorbent portion.

50. The securement device of either one of paragraph 48 or paragraph 49, wherein the absorbent portion has a proximal face to be disposed toward the patient when the securement device is attached to the patient, and optionally the proximal face of the absorbent portion includes a fluid communication surface for fluid communication with the patient, and optionally in contact with the patient, when the securement device is attached to the skin of the patient.

51. The securement device of any one of paragraphs 48-50, wherein the attachment pad comprises an adhesive surface to adhere the attachment pad to the skin of a patient, and optionally the adhesive surface is configured to adhere the adhesive pad to the skin completely around an outer periphery of the proximal side of the absorbent portion configured to be disposed toward the patient.

52. The securement device of paragraph 51, wherein;the attachment pad comprises a perforated layer of adhesive covering a least a portion of the proximal face of the absorbent portion; andperforations through the perforated layer of adhesive provide fluid communication passages across the perforated layer of adhesive, providing for fluid communication of exudate from the patient across the perforated layer of adhesive to be absorbed by the absorbent portion when the attachment pad is attached to the skin of the patient.

53. The securement device of any one of paragraphs 48-52, wherein the absorbent portion has an absorbent capacity of at least 500% by weight, determined as absorption to saturation of 0.9% wt./vol. saline (isotonic saline) relative to the weight of the absorbent portion.

54. The securement device of any one of paragraphs 48-52, wherein the absorbent portion comprises absorbent material, optionally selected from the group consisting of hydrophilic polymers, natural fibers (e.g., cotton), hygroscopic gels (e.g., hydrogels) and combinations thereof.

55. The securement device of any one of paragraphs 48-54, wherein the absorbent portion has an absorbent capacity to absorb at least 1 milliliter, determined as absorption to saturation of 0.9% wt./vol. saline (isotonic saline).

56. The securement device of any one of paragraphs 48-55, wherein the absorbent portion comprises a proximal face configured to be disposed toward the skin of a patient, and preferably with at least a portion of the proximal face configured to contact the skin, when the securement device is attached to the skin.

57. The securement device of paragraph 56, wherein the proximal face of the absorbent portion has a surface area of at least 4 square centimeters, and optionally up to 18 square centimeters.

58. The securement device of either one of paragraph 56 or paragraph 57, wherein:optionally, the attachment pad is in the absence of adhesive covering any portion of proximal face of the absorbent portion; andalternatively optionally, the attachment pad comprises a adhesive covering a portion of but not covering another portion of the proximal face of the absorbent portion, and preferably with this alternative option the adhesive over a portion of the proximal face is in a perforated layer of adhesive on the proximal face with perforations through the perforated layer of adhesive comprising some or all of the other portion of the proximal face not covered by the adhesive and wherein the perforations through the perforated layer of adhesive provide fluid communication across the perforated layer of adhesive to proximal face of the absorbent portion, providing for flow of exudate from the patient across the perforated layer of adhesive to be absorbed by the absorbent portion when the attachment pad is attached to the skin of the patient.

59. The securement device of any one of paragraphs 56-58, wherein the proximal face has a circular outer perimeter.

60. The securement device of any one of paragraphs 56-59, comprising an opening in the proximal face of the absorbent portion for the tube passage.

61. The securement device of any one of paragraphs 56-60, wherein the proximal face extends in a plane perpendicular to a longitudinal direction of the tube passage through the absorbent portion.

61.1 The securement device of any one of paragraphs 48-61, wherein the absorbent portion comprises an antimicrobial agent, and optionally the absorbent portion is configured for fluid communication between the patient and the antimicrobial agent when the attachment pad is attached to the skin of the patient.

61.2 The securement device of any one of paragraphs 1-61.1, wherein the attachment pad comprises an antimicrobial agent, optionally in an adhesive layer of the attachment pad.

61.3 The securement device of paragraph 61.2, wherein the attachment pad is configured for fluid communication between the patient and the antimicrobial agent with the attachment pad is attached to the skin of the patient.

Other Sleeve Features

62. The securement device of any one of paragraphs 1-61.3, wherein as coupled to the attachment pad, the proximal end of the securement sleeve has a fixed position relative to the attachment pad, and optionally the distal end of the securement sleeve does not have a fixed position relative to the attachment pad.

63. The securement device of any one of paragraphs 1-62, wherein the securement sleeve is configured to vary a maximum cross-dimension of the cross-sectional area (e.g., diameter of a circular cross-section) by at least 10 percent relative to a maximum expanded size of the cross-sectional area.

64. The securement device of any one of paragraphs 1-63, wherein the securement sleeve is configured to vary a maximum cross-dimension of the cross-sectional area (e.g., diameter of a circular cross-section) by at least 1 millimeter and preferably by at least 1.5 millimeters.

65. The securement device of any one of paragraphs 1-64, whereinthe securement sleeve is configured to retain in the securement portion a portion of a medical tube having a maximum outer cross-dimension, transverse to a longitudinal direction of the medical tube, and preferably the outer cross-section of the medical tube is a circular cross-section and the maximum outer cross-dimension is an outer diameter of the circular cross-section of the medical tube; andthe securement sleeve is configured to vary a maximum cross-dimension of the cross-sectional area (e.g., diameter of a circular cross-section) at least over a range of from a lower limit of at least 1 millimeter smaller than, and optionally at least 1.5 millimeters smaller than, the maximum outer cross-dimension and having an upper limit of at least 1 millimeter larger than, and optionally at least 1.5 millimeters larger than, the maximum outer cross-dimension, and optionally the lower limit is not more than 2 millimeters smaller than the maximum outer cross-dimension and, optionally, the upper limit is not more than 2 millimeters larger than the maximum outer cross-dimension.

66. The securement device of any one of paragraphs 1-65, wherein the cross-sectional area of the tube passage is circular.

67. The securement device of any one of paragraphs 1-66, wherein the securement portion of the securement sleeve is made of a textile (e.g., with a braided, woven, knitted, crocheted, knotted, tatted, felted or bonded structure with interlacing fibers), and optionally the securement portion is coated with and/or doped to release a sanitary component selected from the group consisting of an antimicrobial agent and/or an antiseptic.

68. The securement device of paragraph 67, wherein the textile is made of a material of construction selected from the group consisting of metallic materials, polymeric materials and combinations thereof; andpreferably the material of construction comprises a polymeric material, optionally the material of construction comprises a polymeric material selected from the group consisting of polyethylene terephthalate, nylon and polyester.

69. The securement device of any one of paragraphs 1-68, wherein;the securement sleeve is configured to retain in the securement portion a portion of a medical tube having a maximum outer cross-dimension, transverse to a longitudinal direction of the medical tube, and preferably the medical tube has a circular cross-section and the outer cross-dimension is an outer diameter of the circular cross-section; andthe securement portion of the securement sleeve has a length longitudinally along the securement sleeve of at least 5 times, preferably at least 10 times and more preferably at least 12 times, the maximum outer cross-dimension, and optionally up to 30 times, preferably up to 25 times and more preferably up to 20 times, the maximum outer cross-dimension, with one preferred range for 5 millimeter outer diameter medical tube being from 6 to 10 centimeters.
Products and Kits

70. A medical tube securement product, comprising:the securement device of any one of paragraphs 1-69, wherein the attachment pad comprises the adhesive surface configured to adhere the attachment pad to the skin of a patient; anda peelable backing adhered to and covering the adhesive surface and configured to be peeled from the adhesive surface to expose the adhesive surface for adherence of the attachment pad to the skin of a patient; andoptionally the adhesive surface comprises an acrylic adhesive, and optionally the adhesive is impregnated with an antimicrobial agent.

71. The product of paragraph 70, wherein the securement device comprises the absorbent portion of any one of paragraphs 56-61.1, and wherein the peelable backing covers a proximal face of the absorbent portion and is configured to expose at least a portion of, and optionally all of, the proximal face of the absorbent portion when the peelable backing is peeled from the adhesive surface, and optionally the peelable backing contacts the absorbent portion.

72. The product of either one of paragraph 70 or paragraph 71, wherein the adhesive surface of the attachment pad has a surface area equal to the surface area of the adhesive pad of at least 25, and preferably at least 45 square centimeters, and preferably in a range having an upper limit of 90 square centimeters.

73. The product of any one of paragraphs 70-72, wherein the peelable backing is not adhered to the proximal face of the absorbent portion.

74. The product of any one of paragraphs 70-73, comprising a hermetically-sealed enclosure in which is disposed the securement device with the peelable backing adhered to the adhesive surface of the attachment pad, preferably with the securement device in the enclosure and the interior environment in the enclosure being sterile.

75. A medical tube securement kit, optionally a medical drain tube securement kit, comprising:the securement device of any one of paragraphs 1-69, optionally in the medical tube securement product of any one of paragraphs 70-74 and alternatively optionally not in the medical tube securement product of any one of paragraphs 70-74; andat least one additional component selected from the group consisting of:(i) a medical tube configured to be translatable through the tube passage when the cross-sectional area of the tube passage in the securement portion of the securement sleeve is in an expanded configuration and to be gripped and held by the securement portion when the cross-sectional area of the tube passage in the securement portion of the securement sleeve is in a contracted configuration, and optionally with an introduction trocar for the medical tube;(ii) a tissue penetration instrument configured to penetrate through tissue to provide a surgical path sized for insertion of a medical tube to be secured by the securement device, optionally selected from the group consisting of a trocar, a tendon passer and combinations thereof;(iii) a fluid collection system configured to fluidly connect with a distal end of a medical tube to be secured by the securement device to collect biological fluid draining through the medical tube, optionally the fluid collection system comprises a collection container configured to collect and retain collected biological fluid and alternatively or additionally optionally the fluid collection system comprises a fluid evacuation container configured to initially collect biological fluid and that is compressible to evacuate biological fluid from the evacuation container (optionally into another fluid container) and apply a vacuum suction to the medical tube (e.g., a bulb evacuator or a bellows-type evacuator, such as for example a HEMOVAC® compact evacuator);(iv) an absorbent pad (separate from the securement device) configured to absorb exudate prior to or as a consequence of insertion of a medical drain to be secured by the securement device, optionally having any feature or features described for an absorbent portion of the securement device;(v) an antiseptic wipe (e.g., alcohol wipe) to clean around a location on a patient where a medical tube is to be inserted to be secured by the securement device;(vi) skin preparation wipes to prepare skin of a patient for attachment of the attachment pad of the securement device, optionally to prepare skin for enhanced adhesion between the attachment pad of the securement device and the skin;(vii) the compression retainer of any one of paragraphs 28-38 and 47, whether or not in place to retain the securement sleeve in the compressed configuration (e.g., the compression retainer can be included in the kit as a component separate from the securement device and which can be installed on the securement device as needed to retain the securement sleeve in the compressed configuration, or the kit can include the securement device including the compression retainer pre-installed with the securement sleeve held in the compressed configuration);(viii) an adhesion component to apply to the skin to assist adhesion of the attachment pad to the skin (e.g., benzoin-containing formulations, Mastosol® liquid adhesive), optionally in a wipe or in an ampule;(ix) an antimicrobial agent for antimicrobial treatment of skin of a patient in a vicinity of the where the securement device is or is to be attached to the skin, optionally the antimicrobial agent is provided in a form selected from the group consisting of a cream, ointment, wipe and combinations thereof; and(x) combinations of any two, three, four, five, six, seven, eight or nine of items (i)-(ix). When a member of any of (i)-(ix) is included in a kit, the kit will include at least one such member, but may include a plurality of such members (e.g., a plurality of absorbent pads, antiseptic wipes, skin preparation wipes, ampules or wipes with an adhesion component, or wipes or other forms with an antimicrobial).

76. The kit of paragraph 75, wherein the medical tube is disposed through the tube passage.

77. The kit of paragraph 76, wherein the cross-sectional area in the securement portion is in an expanded configuration in which the medical tube is not gripped and held by the securement portion of the securement sleeve.

78. The kit of paragraph 76, wherein the cross-sectional area in the securement portion is in the contracted configuration with the medical tube gripped and held by the securement portion of the securement sleeve.

79. The kit of paragraph 78, wherein the medical tube is held by the securement portion up to a tension load applied to the tube distally of a distal end of the securement portion of at least 7 Newtons, and preferably at least 10 Newtons.

80. The kit of paragraph 79, wherein the securement sleeve is retained in a bent configuration with a bend in the securement sleeve that produces a corresponding bend in the tube passage through the securement sleeve and a corresponding bend in the medical tube disposed through the tube passage.

81. The kit of paragraph 80, wherein at least a portion of the bend in the tube passage is in the securement portion of the securement sleeve with the securement portion gripping and holding a bent portion of the medical tube.

82. The kit of paragraph 81, wherein in the bent configuration the medical tube is held by the securement portion up to a tension load applied to the tube distally of a distal end of the securement portion of at least 10 Newtons, and preferably at least 15 Newtons.

83. The kit of either one of paragraph 81 or paragraph 82, wherein the securement sleeve is releasable from being held in the bent configuration, and in the bent configuration the medical tube is held by the securement portion up to a tension load applied to the medical tube of at least 20 percent larger, and preferably at least 30 percent larger, than a corresponding applied tension load when the securement sleeve is released from the bent configuration, and optionally not larger than 100 percent larger than the corresponding applied tension load when the securement sleeve is released from the bent configuration.

84. The kit of paragraph 83, wherein the securement sleeve is engaged with the bent sleeve holder of the securement device of any one of paragraphs 2-27 and bent sleeve holder retains the securement sleeve in the bent configuration.

Method of Use

85. A method of securing a medical tube to a patient with a securement device having a variable-length securement sleeve and a tube passage through the securement sleeve to receive a medical tube for securement, wherein the securement sleeve includes a securement portion and in the securement portion a cross-sectional area of the tube passage transverse to a longitudinal path of the tube passage expands as the securement sleeve is shortened and contracts as the securement sleeve is lengthened and the length of the securement sleeve is adjustable to expand the cross-sectional area to receive the medical tube for translation through the tube passage and to contract the cross-sectional area to grip the medical tube in the tube passage in the securement portion to secure the medical tube to the securement device, the method comprising:with a medical tube extending through the tube passage and into the body of a patient, gripping the medical tube in the tube passage with the securement portion of the securement sleeve; andoptionally, the securement device is according to any one of paragraphs 1-69, and further optionally the securement device is provided in a product or kit according to any one of paragraphs 70-84.

86. The method of paragraph 85, comprising, with the medical tube gripped by the securement portion in the tube passage, bending the securement sleeve to a bent configuration to impart a corresponding bend in the medical tube in the tube passage in the securement sleeve.

87. The method of paragraph 86, wherein in the bent configuration the securement sleeve, and the medical tube in the tube passage in the securement sleeve, is bent by an angle of at least 60°, preferably at least 80° and more preferably at least 90° between longitudinal ends of the securement sleeve.

88. The method of either one of paragraph 86 or paragraph 87, comprising fixing the securement sleeve in the bent configuration with the medical tube disposed therethrough.

89. The method of paragraph 88, wherein:the securement device comprises a bent sleeve holder selectively engageable and disengageable with the securement sleeve to selectively retain and not retain the securement sleeve in the bent configuration; andthe fixing comprises engaging the securement sleeve with the bent sleeve holder to retain the securement sleeve in the bent configuration.

90. The method of paragraph 89, wherein the bent sleeve holder is according to any one of paragraphs 2-27.

91. The method of any one of paragraphs 89-90, comprising adjusting a radial position of the bent sleeve holder relative to the securement sleeve, preferably by a radial distance of at least 5°, and optionally prior to the bending.

92. The method of paragraph 91, wherein the adjusting the radial position of the bent sleeve holder is performed prior to the engaging the securement sleeve with the bent sleeve holder to fix the securement sleeve in the bent configuration.

93. The method of either one of paragraph 91 or paragraph 92, wherein the adjusting the radial position is performed prior to the gripping the medical tube in the tube passage with the securement portion of the securement sleeve.

94. The method of either one of paragraph 91 or paragraph 92, wherein the adjusting the radial position is performed while the medical tube is gripped in the tube passage by the securement portion of the securement sleeve.

95. The method of any one of paragraphs 91-94, wherein the adjusting the radial position comprises rotating the rotating member relative to the base member of the securement device of any one of paragraphs 19-26.

96. The method of any one of paragraphs 91-95, comprising after the adjusting the radial position, locking the bent sleeve holder in place in a selected radial position with a radial positioning lock of the securement device, and optionally the locking comprises selective engagement of corresponding interlocking first and second lock structures of the base member and the rotating member of either one of paragraph 20 or paragraph 21.

97. The method of any one of paragraphs 86-96, wherein:the securement sleeve has a proximal end disposed toward where the medical tube enters the body of the patient and a distal end opposite the proximal end; anda portion of the medical tube in the securement sleeve has a maximum cross-dimension transverse to a longitudinal direction of the medical tube (e.g., outer diameter of a circular tube) and in the bent configuration at least a portion of, and preferably the entirety of, the medical tube in the tube passage in the securement sleeve distal of the bend in the tube is retained within a standoff distance from the body of the patient of not greater than 10 times, preferably not greater than 7 times and more preferably not greater than 6 times a maximum outer cross-dimension, and optionally the standoff distance is at least 3 times or even at least 4 times the maximum outer cross-dimension.

98. The method of any one of paragraphs 88-97, comprising releasing the securement sleeve from the bent configuration.

99. The method of paragraph 98, comprising after the releasing the securement sleeve from the bent configuration, applying longitudinally-applied compression to the securement portion to release the medical tube from being gripped by the securement portion.

100. The method of paragraph 99, comprising while applying the longitudinally-applied compression, removing the medical tube from the patient and from the securement sleeve; andoptionally, after the removing the medical tube, detaching the securement device from the patient.

101. The method of any one of paragraphs 85-98, comprising detaching the securement device from the patient and removing the medical tube from inside of the patient while the medical tube remains gripped by the securement portion of the securement sleeve; andoptionally, comprising a member selected from the group consisting of:during the detaching the medical tube, and further optionally during the removing the medical tube, the medical tube is retained in the bent configuration of any one of paragraphs 86-97; andprior to the detaching the medical tube, the medical tube in the bent configuration of any one of paragraphs 86-97 and is released from the bent configuration, and during the detaching the medical tube, and further optionally during the removing the medical tube, the medical tube is not in the bent configuration.

102. The method of paragraph 99, comprising, after the applying longitudinally-applied compression, performing a procedure selected from the group consisting of:repositioning the medical tube within the securement portion to adjust a location of the medical tube in the patient, gripping the repositioned medical tube with the securement portion and then bending the securement sleeve with the repositioned medical tube into and fixing the securement sleeve in the bent configuration;removing the medical tube from the patient and the securement sleeve, inserting a new medical tube through the securement sleeve and into the patient and then bending the securement sleeve with the new medical tube into and fixing the securement sleeve in the bent configuration; andadjusting a radial position of the bent sleeve holder of any one of paragraphs 89-96 to a new radial position, locking the bent sleeve holder in place in the new radial position and then bending the securement sleeve with the medical tube into the bent configuration and fixing the securement sleeve in the bent configuration with the bent sleeve holder in the new radial position.

103. The method of any one of paragraphs 85-102, wherein:prior to the gripping, the securement sleeve with the medical tube disposed therethrough is retained in a compressed configuration by a compression retainer, and in the compressed configuration the securement portion of the securement sleeve is under longitudinally-applied compression as a consequence of the compression retainer, and optionally the compression retainer is of the securement device of any one of paragraphs 28-38; andthe gripping comprises manipulating the compression retainer, optionally by disengaging the compression retainer from the securement device, to release the securement sleeve from the compressed configuration and to contract a cross-sectional area of the tube passage in the securement portion to grip the medical tube with the securement portion.

104. The method of any one of paragraphs 85-103, comprising attaching the securement device to the skin of the patient through an attachment pad of the securement device, optionally the attachment pad of the securement device of any one of paragraphs 1-69, and preferably the attaching comprises adhering the attachment pad to the skin with an adhesive.

105. The method of paragraph 104, wherein prior to the attaching, an adhesive surface of the attachment pad is covered by a peelable backing and the attaching comprises removing the backing to expose the adhesive surface and adhering the attachment pad to the skin with adhesive of the adhesive surface.

106. The method of either one of paragraph 104 or paragraph 105, wherein:the attachment pad comprises an absorbent portion and the attaching comprises retaining the absorbent portion adjacent the skin; andpreferably, the absorbent portion has an aperture to receive therethrough the medical tube when inserted through the securement sleeve and into the patient, wherein the absorbent portion surrounds a periphery of the medical tube passing through the aperture, to absorb exudate from the patient.

107. The method of paragraph 106, wherein:the absorbent portion comprises a fluid communication surface to be disposed toward the patient, optionally to contact the patient, and in fluid communication with the patient to absorb exudate from the patient when the attachment pad is attached to the skin of the patient;the fluid communication surface of the absorbent portion is covered by the peelable backing prior to the removing the peelable backing; andthe removing the peelable backing exposes the fluid communication surface of the absorbent portion.

108. The method of either one of paragraph 106 or paragraph 107, wherein;the attachment pad comprises a structural sheet; andprior to the removing the peelable backing, the absorbent portion is disposed between the structural sheet and the peelable backing.

109. The method of either one of paragraph 107 or paragraph 108, wherein:the attachment pad comprises a perforated layer of adhesive over a proximal face of the absorbent portion disposed toward the patient when the attachment pad is attached to the skin; andperforations through the perforated layer of adhesive provide fluid communication across the perforated layer of adhesive to the absorbent portion, providing for flow of exudate from the patient across the perforated layer of adhesive to be absorbed by the absorbent portion when the attachment pad is attached to the skin of the patient.

110. The method of paragraph 109, wherein;prior to the removing the peelable backing, the perforations are covered by the peelable backing; andthe perforations are exposed when the peelable backing is removed during the removing the peelable backing.

111. The method of any one of paragraphs 106-110, wherein the securement device is according to any one of paragraphs 48-61.1 comprising the absorbent portion, and optionally in the product or kit of any one of paragraphs 70-84.

112. The method of any one of paragraphs 104-111, comprising, prior to the attaching, preparing a site on the patient for attachment of attachment pad to the patient to secure the medical tube at the site, the preparing the site comprising a procedure selected from the group consisting of;(a) treating skin at the site with a preparation wipe to improve the surface of the skin for adherence to the attachment pad, optionally using preparation wipe of the kit of paragraph 75;(b) surgically forming an opening in the patient at the site to accept insertion of the medical tube, optionally using the tissue penetration instrument of the kit of paragraph 75;(c) applying an adhesive component to skin at the site to assist adhesion of the attachment pad to the skin, optionally using the adhesion component of the kit of paragraph 75;(d) cleaning the site with an antiseptic, optionally using an antiseptic wipe of the kit of paragraph 75;(e) treating the site with an antimicrobial agent, optionally using the antimicrobial agent of the kit of paragraph 75; andcombinations of any two, three, four or five of items (a)-(e).

113. The method of claim 112, comprising the procedure of item (b), and wherein the surgical opening accesses an anatomical region selected from the group consisting of intracranial, brain, stomach, small intestine, trachea, heart (e.g., atrium, ventricle), aorta, vena cava, intra-abdominal, thoracic cavity, intra-muscular, subcutaneous, colon, kidney, ureter, and bladder.

Method of Manufacture

114. A method of making a securement device or a product including a securement device, wherein the securement device is configured to secure to a patient a medical tube when inserted into the patient, and optionally the securement device is according to any one of paragraphs 1-69, the method comprising:coupling a securement sleeve to a structural sheet for an attachment pad, optionally the attachment pad according to any one of paragraphs 1-69;the securement sleeve including a securement portion through which the tube passage extends, wherein a cross-sectional area of the tube passage in the securement portion transverse to a longitudinal path of the tube passage expands as the securement sleeve is shortened and contracts as the securement sleeve is lengthened and the length of the securement sleeve is adjustable to expand the cross-sectional area to receive a medical tube for translation through the tube passage in the securement portion and to contract the cross-sectional area to grip the medical tube in the tube passage by the securement portion to secure the medical tube to the securement device, and preferably the securement sleeve is constructed of a textile, and optionally the securement sleeve is the securement sleeve according to any one of paragraphs 1-69; andthe structural sheet for the attachment pad being configured with a proximal side to face a patient during use and a distal side to face away from a patient during use, the proximal side configured to be adhered with adhesive to skin of a patient; andwherein the coupling the securement sleeve to the structural sheet comprises:securing flared end material adjacent a proximal end of the securement sleeve between a first surface of a first securement member and a second surface of a second securement member;wherein the first securement member is selected from the group consisting of the structural sheet with the first surface being on the distal side of the structural sheet and an intermediate member coupled, directly or indirectly, to the distal side of the structural sheet; andoptionally, and preferably, the second securement member is a base member according to any one of paragraphs 19-26.

115. The method of paragraph 114, wherein the securing the flared end material comprises sandwiching the flared end material between and adhering the flared end material to both the first surface to the second surface.

116. The method of paragraph 115, wherein prior to the sandwiching, at least one, and preferably both, of the first surface and the second surface has applied adhesive.

117. The method of paragraph 116, wherein the applied adhesive is pressure sensitive adhesive and the adhering comprises pressing together the first surface and the second surface together with sufficient pressure to activate the pressure sensitive adhesive to adhere the flared end material to the first and second surfaces, and preferably the pressure is at least 60 kilopascals (kPa).

118. The method of any one of paragraphs 114-117, comprising;connecting a rotating member, optionally the rotating member of any one of paragraphs 19-26, to a preliminary product form for the securement device, the preliminary product form including the structural sheet, wherein as connected to the preliminary product form the rotating member is rotatable relative to the structural sheet;optionally, and preferably, the preliminary product form includes the base member of any one of paragraphs 19-26, wherein the connection to the preliminary product form comprises engagement of the rotating member with the base member with the rotating member being rotatable relative to the base member between the base member and the rotating member is a rotatable connection with the rotating member being rotatable relative to the base member;and preferably the connecting the rotating member to the preliminary product form occurs after any processing according to any of paragraphs 114-117.

119. The method of paragraph 118, wherein the connecting the rotating member to the preliminary product form comprises sliding the rotating member over the securement sleeve disposed through an aperture in the rotating member until the rotating member engages a connection location on the preliminary product form, and preferably the connection location is on the base member.

120. The method of either one of paragraph 118 or paragraph 119 wherein:the connecting the rotating member to the preliminary product form comprises engaging the rotating member with exterior engagement features of an axle, and wherein as engaged with the axle the rotating member is rotatable about the axle; andoptionally, and preferably, the axle comprises at least a portion of the extension portion of the base member according to paragraph 25.

121. The method of paragraph 120, wherein the axle has an aperture extending in a longitudinal direction through the axle, and preferably the aperture extends longitudinally through the extension portion of the base member, and the preliminary product form comprises the securement sleeve extending through the aperture of the axle, and preferably through the extension portion of the base member, and wherein as engaged with the axle the rotating member is rotatable about the securement sleeve.

122. The method of any one of paragraphs 114-121, comprising retaining a distal end portion of the securement sleeve in a distal collar assembly, optionally the distal collar assembly according to any one of paragraphs 45-47, and optionally the retaining a distal end portion of the securement sleeve occurs after the connecting a rotating member with the preliminary product form according to any one of paragraphs 118-121.

123. The method of paragraph 122, wherein the retaining a distal end portion of the securement sleeve in the distal collar assembly comprises:inserting a collar nipple into the distal end portion of the securement sleeve and disposing a retaining member over the distal end portion of the securement sleeve biasing a sleeve wall of the distal end portion toward the collar nipple.

124. The method of any one of paragraphs 114-123, comprising attaching an absorbent pad to the proximal side of the structural sheet, and optionally the absorbent pad provides the absorbent portion according to any one of paragraphs 48-61.1.

125. The method of paragraph 124, wherein the attaching the absorbent pad to the proximal side of the structural sheet comprises:applying adhesive over the proximal side of the structural sheet, preferably a pressure sensitive adhesive;and after applying the adhesive, locating the absorbent pad to cover at least a portion of the adhesive over the proximal side of the structural sheet; andattaching the absorbent pad to the proximal side of the structural sheet with the adhesive.

126. The method of paragraph 125, comprising:after the locating the absorbent pad to cover at least a portion of the adhesive, covering the absorbent pad, and optionally also covering an exposed portion of the adhesive on the proximal side of the structural sheet not covered by the absorbent pad, with a peelable backing; andadhering the peelable backing to the attachment pad with the absorbent pad disposed between the peelable backing and the structural sheet.

127. The method of paragraph 126, wherein the adhesive comprises pressure sensitive adhesive and the attaching the absorbent pad to the proximal side of the attachment pad comprises applying pressure to the absorbent pad disposed between the proximal side of the attachment pad and the peelable backing.

128. The method of any one of paragraphs 114-127, comprising applying longitudinally-applied compression to at least a portion of the securement sleeve to shorten the securement sleeve into a compressed configuration and retaining the securement sleeve in the compressed configuration with a compression retainer.

129. The method of paragraph 128, wherein the retaining the securement sleeve in the compressed configuration comprises engaging the compression retainer with the base member of any one of paragraphs 114-121 and with the distal collar assembly of either one of paragraph 122 or paragraph 123.

130. The method of any one of paragraphs 114-129, comprising:completing the securement device; andsealing the securement device inside a hermetically-sealed enclosure, and optionally the securement device as sealed in the hermetically-sealed enclosure is in a product according to any one paragraphs 70-74; andsterilizing the securement device, optionally the sterilizing is performed prior to the sealing and alternatively optionally the sterilizing is performed after the sealing (e.g., by irradiation of the securement device within the hermetically-sealed enclosure).

131. The method of paragraph 130, comprising packaging within a common packaging enclosure the securement device together with at least one additional component for a kit according to any one of paragraphs 75-84, optionally the common packaging enclosure is the hermetically-sealed enclosure and alternatively optionally the common packaging enclosure encloses the hermetically-sealed enclosure containing the securement device or product including the securement device.

Other Medical Tube Features

132. The securement device, product, kit or method of any one of paragraphs 1-131, wherein a portion of the medical tube configured to be received through the securement portion has a maximum outer cross-dimension (e.g., outer diameter of a circular tube cross-section) that is larger than a maximum cross-dimension of the tube passage in the securement portion (e.g., inner diameter of circular tube cross-section) when the securement sleeve is in a relaxed state.

133. The securement device, product, kit or method of any one of paragraphs 1-132, wherein a portion of the medical tube configured to be received through the securement portion has a maximum outer cross-dimension (e.g., diameter of a circular tube cross-section), transverse to a longitudinal direction of the medical tube, in a range of from 2 to 14 millimeters (6 to 42 French gauge), and optionally the maximum outer cross-dimension is selected from the group consisting of about 2 millimeters (e.g., 6 French gauge), about 3.3 millimeters (e.g., 10 French gauge), about 5 millimeters (e.g., 15 French gauge), about 6.3 millimeters (e.g., 19 French gauge), about 8 millimeters (e.g., 24 French gauge), about 9.3 millimeters (e.g., 28 French gauge), about 10.7 millimeters (e.g., 32 French gauge) and about 14 millimeters (e.g., 42 French gauge).

134. The securement device, product, kit or method of any one of paragraphs 1-133, wherein a portion of the medical tube configured to be received through the securement sleeve has a circular outer perimeter in a cross-section transverse to a longitudinal direction of the medical tube, and preferably a fluid flow path through the medical tube has a circular cross-section.

135. The securement device, product, kit or method of any one of paragraphs 1-134, wherein the medical tube is made of a material of construction selected from the group consisting of silicone (polysiloxane), polyethylene and polyvinyl chloride.

The foregoing description of the present invention and various aspects thereof has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain known modes of practicing the invention and to enable others skilled in the art to utilize the invention in such or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.

Unless expressly stated otherwise or necessarily required by the context, for example based on feature incompatibility: description or illustration of a feature or features in a particular combination do not exclude inclusion in the combination of an additional feature or features; disclosed apparatus, kits, systems, and products may include additional features not disclosed, including intermediate structures between disclosed structures; references to coupling, attachment and the like of features or structures include direct coupling, attachment or the like of the features or structures and also include indirect coupling, attachment and the like including one or more additional intermediate structures or features; disclosure of elements or structure as being between other elements or structures does not preclude the inclusion of additional elements or structures also being between the other elements or structures; disclosures of processing steps and sequencing do not exclude inclusion of other steps or other sequencing of steps.

The terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms, are intended to be inclusive and nonlimiting in that the use of such terms indicates the presence of a stated condition or feature, but not to the exclusion of the presence also of any other condition or feature. The use of the terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms in referring to the presence of one or more components, subcomponents or materials, also include and is intended to disclose the more specific embodiments in which the term “comprising”, “containing”, “including” or “having” (or the variation of such term) as the case may be, is replaced by any of the narrower terms “consisting essentially of” or “consisting of” or “consisting of only” (or any appropriate grammatical variation of such narrower terms). For example, a statement that something “comprises” a stated element or elements is also intended to include and disclose the more specific narrower embodiments of the thing “consisting essentially of” the stated element or elements, and the thing “consisting of” the stated element or elements. Examples of various features have been provided for purposes of illustration, and the terms “example”, “for example” and the like indicate illustrative examples that are not limiting and are not to be construed or interpreted as limiting a feature or features to any particular example. The term “at least” followed by a number (e.g., “at least one”) means that number or more than that number. The term at “at least a portion” means all or a portion that is less than all. The term “at least a part” means all or a part that is less than all. The term “at least a majority” means all or a majority part that is less than all.