A variety of medical devices are commonly attached to patients for extended periods of time, for a variety of reasons and in a variety of ways (e.g., adhesively, implanted, inserted into, attached via straps or other attachment members, etc.). For example, venous catheters, peritoneal catheters and pumps (such as those used for dialysis), gastric feeding tubes (“G-tubes”), various types of drainage tubes, various other types of vascular catheters, and various other medical devices are commonly implanted or otherwise attached to patients. In many such instances, a portion of the medical device (e.g., one or more conduits such as catheter tubes and/or electrical leads) extends out of or otherwise away from the patient's body. As a result, the patient often will have a portion of the medical device which must be secured in some manner, particularly when the device is not being used. If not secured in some manner, a loose portion of the medical device may get in the way of normal activities or may even be inadvertently pulled or become entangled to the point that the device itself is compromised and/or the patient suffers adverse consequences (e.g., irritation, pain, inflammation, or worse). In addition, a visible exterior portion of the medical device (e.g., catheter tubing or electrical leads) may also cause embarrassment for the patient, particularly children.
By way of example, venous catheters are commonly used in a variety of medical procedures for a variety of reasons. In many instances, venous catheters must remain in place for an extended period of time, such as for intravenous (“IV”) therapy, the frequent drawing of blood samples from a patient and/or other therapeutic or diagnostic medical procedures such as dialysis or apheresis. For example, IV therapy involves the administration of medications directly into a patient's vein through an inserted catheter. In some cases, IV therapy over an extended period of time is necessary, such as for administrating chemotherapy regimens, administering antibiotic regimens, or parenteral nutrition. Such extended duration IV therapy is typically accomplished through a peripherally inserted central catheter line (“PICC line”), or through a more central location with a central venous catheter (such as a Broviac catheter, Hickman line or a Groshong line).
A central venous catheter is typically a soft, flexible tube, with one or more internal lumens that has a larger diameter than a PICC line. A Broviac catheter is a central venous catheter with a smaller lumen as compared to a Hickman line, and is commonly used for small children. The central venous catheter is placed directly into a large vein in the neck, chest, or groin, and can remain in situ for extended periods of time. On the other hand, PICC lines and central venous catheters are more patient-friendly since they necessitate only one tube insertion rather than repeated ones.
Once inserted, a small length of the central venous catheter remains external to the patient, extending outwardly from, for example, the patient's chest (at a variety of possible locations), adjacent the patient's clavicle, or other region of the upper torso. In the case of multi-lumen catheters, while a single tube with multiple internal lumens extends outwardly from the patient's body, the multiple lumens branch into individual tubes from an external hub assembly and connectors (e.g., luer fittings) are typically provided at the ends of the individual tubes for connection to an infusion pump or other medical device. The external ends of the tube(s) of the central venous catheter are also typically capped in order to prevent contamination.
The external portion of a central venous catheter often dangles, unsupported, near the point of entry. There is a constant danger of pulling, dislodgement or other interference with the central venous catheter during normal daily activities or even during sleep. This movement or dislodgment may prevent the administered liquids from reaching the desired veins, or cause significant inflammation to the insertion point, air embolisms, arterial punctures, internal bruising, and/or blood clots. The problem of movement of the external portion of the catheter assembly is especially pronounced in young children undergoing long-term therapy with a central venous catheter.
Previous solutions to prevent movement of central venous catheters and other medical devices having dangling conduits (e.g., tubes and/or electrical leads) have included taping the external small length of the lines to the patient's skin with medical tape. These tapes often leave adhesive residues that are irritating to the skin. These irritations can lead patients to inadvertently scratch the insertion points, thereby moving the small length of the external catheter. While newer medical tapes reduce or virtually eliminate adhesive residue, such tapes are not as strong and still can irritate the skin surrounding the insertion point. The tape can also lead to pain, inflammation, infections, and/or reduced efficacy of the medical device. Furthermore, the medical tape often must be partially removed in order to access the catheter and then re-taped once the IV therapy or other medical treatment is completed. This removal of the tape and re-taping to the skin can result in significant irritation. Moreover, when the end of the central venous catheter is taped visibly from the outside of the patient's clothing, it presents an unsightly and disturbing appearance that can produce mental distress.
It is also desirable to protect catheter tubing or other portions of medical devices from being pierced or otherwise punctured or damaged due to movement. A pierced or punctured central venous catheter, for example, not only prevents administered liquids from reaching the desired vein, it may also allow bacteria or other contaminants to enter, causing internal infections in the patient.
By way of further example, various electrical medical devices are also commonly attached to patients, such as portable electrocardiography devices (also known as Holter monitors) and transcutaneous electrical nerve stimulation devices (also known as TENS devices). Holter monitors and TENS devices have a plurality of electrodes attached to the patient (e.g., adhesively), electrical leads extending from those electrodes, and a portable unit to which the electrical leads are connected. The portable unit generally should be secured in some manner so that the electrical leads remain connected thereto. This may be accomplished, for example, by hanging the portable unit from the patient's neck or clipping the unit to the patient's belt. While Holter monitors and portable TENS devices are designed to allow the patient to be mobile and engage in everyday activities, the patient still must be careful to not allow the electrical leads to become entangled or otherwise pulled (e.g., by becoming caught or snagged by something during normal activities) else the electrodes may become detached from the patient or even damaged.
While a variety of devices and techniques may exist for protecting, retaining and/or concealing various medical devices such as catheters or electrical leads, it is believed that no one prior to the inventors has made or used an invention as described herein.
While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings.
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples should not be used to limit the scope of the present invention. Other features, aspects, and advantages of the versions disclosed herein will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the versions described herein are capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
For example, although various embodiments of medical garments will be described for use by a patient having a central venous catheter in place, embodiments of the medical garments described herein can be used for a wide variety of medical devices attached to a patient, by implantation or otherwise, for any length of time. Medical garments described herein may be used with any of a variety of medical devices which include or comprise one more conduits used for medical treatment or diagnosis, including conduits which comprise catheters as well as electrical conduits such as electrical leads. For example, medical garments according to some embodiments of the present invention can be adapted for use with peritoneal catheters and pumps (such as those used for dialysis), gastric feeding tubes (“G-tubes”), various types of drainage tubes, various other types of vascular catheters, electrical leads, including medical devices which include or require electrical leads (e.g., Holter monitors or portable TENS devices), airway tubes, and various other medical devices. Thus, the present invention is not limited to medical garments specifically adapted for or intended to be used by patients having a central venous catheter in place.
Embodiments described herein provide a medical garment which facilitates a patient's engaging in normal daily activities while a medical device such as a central venous catheter remains attached to the patient. Garments described herein not only conceal the medical device when it is not being used (and in some cases while it is being used), but also prevent portions of the medical device becoming entangled or pulled during normal activities of the patient.
Embodiments of the medical garment described herein include a storage pocket, and an access opening located within the pocket through which a portion of a medical device attached to a patient (e.g., a portion of catheter tubing and/or a component of a medical device such as electrical leads) may pass from the interior of the garment into the pocket. In some embodiments, the access opening may also be used to access the patient adjacent the garment's access opening in order to, for example, examine and/or clean a catheter exit site in the patient's skin without having to remove the garment and, in some instances, without having to open the garment (other than the pocket).
Some embodiments further include an anchor secured (permanently or removably) within the pocket, wherein the anchor is adapted to retain a portion of a medical device (e.g., catheter tubing or other conduit such as electrical leads) in order to limit movement of the retained portion. In these embodiments, the anchor is load bearing with respect to the portion of the medical device extending from the patient through the access opening into the pocket and provides strain relief. The load bearing and strain relief features of the anchor help to prevent or reduce the transfer of a pulling force on the medical device to the location where the device is attached to or otherwise enters the patient. For example, when a catheter tube is retained by the anchor, the anchor (and the garment itself) will resist any pulling force applied to the catheter tube (by gravity or otherwise), thereby reducing or eliminating force applied to the catheter at the site of insertion into the patient. In other words, the anchor helps to prevent the catheter (or other medical device portion retained by the anchor) from tugging on the catheter exit wound (or other location where the medical device is attached to or enters a patient).
Some embodiments are also configured to allow the medical garment to be donned or removed by a patient (or positioned on or removed from a patient) without the need to remove or disconnect the medical device attached to the patient, even if that medical device is being used at the time. For example, embodiments allow the garment to be donned or removed by a patient having a central venous catheter extending from their chest, even while the catheter is being used to infuse medication into the patient.
In one particular embodiment, for example, a medical garment comprises a body portion adapted to be worn on at least the upper torso of a patient, wherein the body portion includes at least one front panel having an outward-facing surface and an inward-facing, skin-contacting surface, as well as back panel having an outward-facing surface and an inward-facing, skin-contacting surface. At least one access opening communicates between the outward- and inward-facing surfaces of the front panel, and in one embodiment extends across at least a portion of the width of the front panel. The access opening may be provided in a unitary front panel (e.g., a slit formed in, and extending across a portion of the width of the front panel). Alternatively, the front panel comprises upper and lower front panels (e.g.,
A pocket-forming outer panel is affixed to the front panel such that a selectively-closeable pocket is provided between the outer panel and at least a portion of the front panel, with the access opening located within the pocket (at least when the pocket is closed) and the extending downwardly beneath the access opening. (In some embodiments, the pocket also extends upwardly from the access opening.)
An anchor is secured to the outward-facing surface of the front panel within the pocket (at least when the pocket is in the closed position), such that the anchor is concealed behind the outer panel when the pocket is in its closed position. The anchor is adapted to releasably secure a portion of a medical device (e.g., catheter tubing or other conduit) within the pocket. By way of one specific example, the anchor comprises a clamp which securely holds a portion of a medical device without interfering with its normal use (e.g., securely clamps a catheter tube but without compressing the catheter tube such that the internal lumen is closed or reduced in diameter).
Any of a variety of conduit anchors may be employed on the medical garment. For example, a clamping-type anchor comprising a clamshell assembly adapted for clamping securement of a catheter or other conduit between adjacent portions (e.g., opposing faces) of the clamshell assembly can be employed. The clamshell assembly is configured to clampingly secure the catheter tubing between a base portion and a clamping portion without exerting so much clamping pressure that the internal lumen of the catheter tubing is closed or reduced in diameter. The clamshell assembly anchor may be configured as a single, unitary structure comprising a base member and a clamping member which are hingedly connected at one end (e.g.,
For a unitary clamshell arrangement, the clamp may be normally biased to an open position whereby the base and clamping members are spaced apart from one another to facilitate the placement of catheter tubing or other conduit between the base and clamping members (e.g.,
Medical garment (10) includes a body portion comprising a front panel (12) having an outward-facing surface (14), an access opening (16) extending through the front panel (12), and an anchor (40) that is attached to the front panel (12). The anchor will typically be attached to the outward-facing surface (14) beneath the access opening (16). As used herein, “beneath” means lower or below, when the garment is worn by a patient standing erect.
The medical garment (10) also includes an outer panel (20) attached to the outward-facing surface (14) of the front panel (12), such that a pocket (P) extends downwardly from anchor (40). The pocket is generally configured to retain a distal length (102) of the tubing (101) that extends below the tubing anchor (40). It will be understood, however, that the pocket may be used to retain any of a variety of items, as further described herein.
The anchor (40) in the embodiment of
The tubing (101) can be retained by anchor (40) in a variety of ways, such as the shape or other feature of one or both of ridges (44), and/or a fastener attached to the base (42) of the anchor (40). The medical garment itself, including outer panel (20), may also be adapted to retain the tubing (101) on or in the anchor (40). The anchor is configured to retain the tubing to anchor (40) during normal daily activities which might otherwise pull the catheter away from the patient causing discomfort, irritation and the like.
As an alternative, the anchor (40) may be configured to include a plurality of channels (48) in order to provide for the releasable retention of a plurality of catheter tubes. In particular, anchor (40) may include a plurality of pairs of opposing, parallel ridges (44A, 44B), which may, for example, extend parallel to one another so as to provide a plurality of parallel, tube-receiving channels (48). As yet another alternative, a plurality of separate anchors (40) may be provided on the medical garment, adjacent to one another in order to provide releasable retention of a plurality of catheter tubes and/or at different locations within the garment pocket in order to provide more than one location for securing one or more catheter tubes within the garment pocket.
In the embodiment shown in
In addition, a separate retainer member can be positioned over the ridges (44) of the tubing anchor (40) after the tubing (101) has been positioned within the channel (48) in order to prevent the tubing from escaping channel (48). For example, a retaining patch (26) can be positioned on an inner surface of a flap (24) that extends from the top edge (22) of outer panel (20). When the flap (24) is folded upwardly to cover the access opening (16) (and the tubing anchor) and thereby close the pocket provided between the outer panel (20) and the front panel (12), as shown in
The flap (24) and/or the front panel (12) may also include one or more fasteners for maintaining the flap in the closed position. A variety of fasteners may be used for the releasable attachment of flap (24) to front panel (12), including conventional buttons (and corresponding button holes or loops), hook and bar fasteners, hook and loop fasteners (e.g., Velcro® brand), and mating snaps. In the embodiment shown, fasteners (28) comprise male (or female) snaps which are located to align with corresponding female (or male) snaps (30) located on the front panel (12) above the access opening (16). The retaining function of the retaining patch (26) can be augmented by including magnetically-attracting elements within the anchor (40) and the retaining patch, or by including a pair of mating fasteners (not shown) on each of the retaining patch (26) and anchor (40).
An alternative embodiment of a snap-fit tubing anchor (140) is depicted in
Like anchor (40), anchor (140) may be configured to include a plurality of channels (148) in order to provide for the releasable retention of a plurality of catheter tubes. Thus, anchor (140) may include a plurality of pairs of opposing, parallel ridges (144A, 144B), which may, for example, extend parallel to one another so as to provide a plurality of parallel, tube-receiving channels (148). Alternatively, a plurality of separate anchors (140) may be provided on the medical garment, adjacent to one another in order to provide releasable retention of a plurality of catheter tubes and/or at different locations within the garment pocket in order to provide more than one location for securing one or more catheter tubes within the garment pocket. Also, the tubing anchor (140) can include a channel liner (similar to liner (255) in
One suitable material for the anchor (140) is silicone or another resilient material, particularly a resilient material that is MRI-, X-Ray- and/or CT-compatible (transparent) material. As further discussed herein, embodiments of the medical garments described herein are substantially or entirely non-metallic, including the various fasteners and fastening arrangements such as snaps used to close various portions of the garment. In this manner, such medical garments are MRI-compatible and will not pose a risk to the patient during MRI imaging.
The closure member (260) is configured to pivot closed (
In the illustrated embodiment, the retaining surface (265) and the channel liner (255) comprise a compressible material such as a compressible foam material, particularly a soft foam material, that can be easily compressed by the outer surface of the tubing (101). The compressible material improves the grip of the tubing anchor on the length of tubing, and can also permit the retaining of tubing of different diameters depending upon the thickness of the compressible material and its range of compression. The length of the anchor (240) in the closed position shown in
The end of anchor (240) opposite that of the hinge is configured to releasably lock the anchor in its closed position using mating fasteners provided at the ends of the closure and base members. Thus, distal end (267) of the closure member (260) includes a first lip (268) at the end of a resilient arm that is configured to fasten to a mating second lip (278) provided at the end of a similar resilient arm extending upwardly from the opposed end (246) of the base member (242). In the illustrated embodiment, the mating first and second lips comprise a latch and a catch arrangement. However, other mating fastener arrangements can be used, including mating magnetically-attracting materials, hook-and-loop mechanical fasteners (also known as Velcro®), and the like.
With tubing 101 is positioned within channel (248), the closure member (260) is pivoted over the base member (242) so that the retaining surface (265) closes over the tubing (101). A force (F1) applied near the end of the closure member (260) causes first lip (268) slide past second lip (278) until the lips engage one another (as shown in
The end of anchor (340) opposite that of the hinge is configured to releasably lock the anchor in its closed position using mating fasteners provided at the ends of the closure and base members. Thus, distal end (367) of the closure member (360) includes a first fastener (368) (e.g., a lip) that is configured to fasten to a mating second fastener (378) (e.g., a lip) at an opposed end (346) of the base (342). In the illustrated embodiment, the mating first and second fasteners are a latch and a catch mechanism, although other mating fasteners can be used, including mating magnetically-attracting materials, hook-and-loop mechanical fasteners (also known as Velcro®), and the like. A first hinge (362) at the end (345) of the base (342) is hingedly attached to one end of a hinge segment (364), which is hingedly attached at its other end to a second hinge (363) at the end of the closure member (360). A force applied near the end (367) of the closure member (360) will secure the mating fasteners (368, 378) to one another in the manner described above for anchor (240). To release the closure member of anchor (340), a force F3 is applied to the closure member intermediate the centerpoint and the end (367), which causes the first fastener (368) to pivot outwardly away from and out of engagement with the second fastener (378). A push button (380) can be positioned at a suitable position for application of the releasing force (F3).
As seen in
The closure member (460) includes a first fastener element comprising distal edge (468). The base (442) includes a mating second fastener (478) that includes an inner ledge (479) for releasably engaging the edge (468) of the closure member (460), and restraining the closure member (460) against the biasing, resilient force of the hinge (464) which biases the anchor to the partially open position of
As shown in
As noted above, embodiments of anchors (40, 140, 240, 340, 440) include one or more tubing retainers (or liners) comprising a resiliently compressible material such as a polymeric foam in order to not only aid in retaining the tubing (or other conduit such as electrical leads) within the anchor, but also to prevent too much force being applied to the conduit such that a tubing, for example, is pinched closed and/or the conduit is damaged. Any of a variety of materials and thicknesses of material may be used. In one specific embodiment, for example, the tubing retainer(s) is about ⅛th inch thick.
An example of a suitable retaining material is a compressible foamed polymeric material that can be easily compressed by the outer surface of the tubing (101), and having a resiliency sufficient to recover to the full rectangular block shape when the tubing is released. The retaining material improves the grip of the tubing anchor on the length of tubing, and can permit the retaining of tubing of different diameters, depending upon the thickness of the retaining material and its range of compression. Any flexible polymeric material which can be foamed having sufficient compressibility and recovery/resiliency can be employed, including polymers of ethylene, propylene, urethane, vinyl chloride, vinyl acetate, diisocyanate, cellulose acetate and isobutylene, and including homopolymers and copolymers thereof. Other monomers can include vinylidene chloride, vinyl esters of carboxylic acids, e.g., vinyl acetate, vinyl propionate, vinyl butyrate and vinyl benzoate, esters of unsaturated acids, e.g., alkyl acrylates such as methyl acrylate, ethyl acrylate, propyl acrylate, butyl acrylate, allyl acrylate, and the corresponding esters of methacrylic acid; vinyl aromatic compounds, e.g., styrene, ortho-chlorostyrene, parachlorostyrene, 2,5-dichlorostyrene, 2,4-dichlorostyrene, paraethylstyrene, vinyl naphthalene and a-methyl tyrene, dienes such as butadiene and chlorobutadiene, unsaturated amides such as acrylic acid amide and acrylic acid anilide; unsaturated nitriles such as acrylic acid nitrile; and esters of a,P-unsaturated carboxylic acids, e.g., the methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, octyl, allyl, methallyl, and phenyl esters of maleic, crotonic and fumaric acids and the like. Such polymers can normally be compounded into plastisol form with a blowing agent and a high concentration of a suitable organic plasticizer so as to result in stabilized foams having the suitable recovery and compression characteristics.
The illustrated tubing anchor can be permanently affixed to the garment, using, for example, a permanent adhesive, stitching, or other well-known methods of securing material to a garment.
Alternatively, the tubing anchor can be temporarily and selectively attached to any surface of the garment, as needed or desired. Temporary attachment of the device to a garment means that the device is fixed to the garment and remains affixed during normal daily routines, but can be readily removed from the garment without damaging the garment. An example of temporary affixing means includes an adhesive material, including a pressure sensitive adhesive (PSA) or equivalent adhesive material. The adhesive material is typically applied to the back surface of the base of the anchor. A plastic release film can be attached to the surface of the adhesive to prevent dust, dirt, and premature attachment until the location of attachment is determined. Other examples of temporary attachment means include a safety pin built into the bottom surface of the garment attaching surface of the anchor, or a mechanical hook-and-loop fastener element, one of the hook or loop elements attached to the garment attaching surface, and the other attached to the garment.
In some embodiments, the anchor may be designed as a replaceable component of the garment. For example, the anchor may include an adhesive (e.g., PSA) on its garment attaching surface (e.g., the bottom surface of the anchor), covered by a release film. When the anchor is needed, the release film is removed and the garment is affixed to a surface of the garment (e.g., to the front panel of the garment, within the pocket). Should the anchor need to be replaced (e.g., no longer clamps tubing sufficiently or the adhesive wears off) or moved to a new location, the old anchor is removed and a new one attached to the garment in the same manner. More than one anchor may also be attached to the garment in order to, for example, provide multiple anchoring locations for tubing or other portions of a medical device.
When access or use of the medical device is needed, the pocket may be easily opened without removing the garment. In addition, as seen in
Garment (510) generally comprises a neck opening (512) adapted to receive a wearer's (e.g., a patient's) neck therethrough, as well as right and left arm openings (514) adapted to receive a wearer's arms therethrough. Neck opening (512) and arm openings (514) may be formed in a variety of ways, such as by affixing (e.g., by stitching) binding strips to the garment panels, as shown. The bottom end (513) of the garment (510) may be finished with a stitched hem, as shown, or in other ways known to those skilled in the art. It should also be pointed out that
Although garment (510) is depicted as being sleeveless, alternative embodiments include short or long sleeves affixed at arm openings (514) in a variety of manners known to those skilled in the art. For example, sleeves may be conventionally attached via stitching, or removably attached using, for example, snaps or other suitable fasteners. Even with sleeves, however, garment (510) can be fully opened and donned or removed without having to remove or disconnect catheter tubing (or other medical devices attached to the patient).
The access opening in garment (510) may be provided by a slit formed in the front panel of the garment, at any of a variety of desired locations. Alternatively, in the embodiment depicted in
As used herein, right and left are defined from a wearer's perspective. Of course one skilled in the art will recognize that the various features described herein with reference to the right and left of the garment can be reversed without departing from the present disclosure. For example, while the pocket and front panels of the medical garment (510) depicted in
In the specific embodiment depicted, and as best seen in
As mentioned above, the access opening in the exemplary embodiment shown in
It is also contemplated that the lower edge of the upper front panel and the upper edge of the lower front panel may overlap, with the access opening provided therebetween, such as depicted in
In the embodiment shown in
The left-most sides (524B, 544B) of the upper and lower front panels (520, 540) are not permanently affixed to left side panel (560B). Instead, as further described below, mating fasteners are provided for releasably attaching left-most sides (524B, 544B) of upper and lower front panels (520, 540) to left side panel (560B).
Upper front panel (520) extends upwardly to neck opening (512), and to right and left upper ends (525A, 525B) along either side of neck opening (512). Right upper end (525A) is affixed (e.g., by stitching) to the corresponding lower edge of right shoulder portion (581A) of back panel (580) (i.e., the portion of back panel (580) which extends over the right shoulder). The left upper end (525B) is not permanently affixed to the left shoulder portion (581B) of back panel (580). Instead, as further described below, mating fasteners are provided for releasably attaching (directly or indirectly) left upper end (525B) of upper front panel (520) to the left shoulder portion (581B) of back panel (580).
Right and left side panels (560A, 560B) extend downwardly from the right and left shoulder portions (581A, 581B) of back panel (580), spaced laterally outward with respect to the upper and lower front panels, and are affixed to the shoulder panels (581A, 581B) at their upper ends (e.g., by stitching). Along the sides of garment (510), right and left side panels (560A, 560B) extend from arm openings (514) (i.e., beneath a wearer's armpit) to the lower edge (513) of the garment. Thus, the outermost sides (562A, 562B) of right and left side panels (560A, 560B) are affixed to the outermost sides (582A, 582B) of back panel (580) (e.g., by stitching, which is not shown in the figures). As mentioned previously, the innermost right side (563A) of right side panel (560A) is affixed to the right-most sides (524A, 544A) of the upper and lower front panels (520, 540), such as by stitching. As further described herein, the innermost side portion (563B) of left side panel (560B), on the other hand, is adapted for releasable attachment to the left-most sides (524B, 544B) of upper and lower front panels (520, 540).
In the exemplary embodiment shown in
Outer panel (552) is provided on the front of garment (510), generally centered across the front width of the garment, and provides the pocket (P) between the inner surface of outer panel (552) and the outer surface of upper and lower front panels (520, 540). Outer panel (552) is affixed (e.g., by stitching) to upper and lower front panels (520, 540) along at least a portion of the right side (553A) of outer panel (552), and to lower front panel (540) along the lower end (554) of outer panel (552). In the particular embodiment shown, and as best seen in
It should be noted that any of a variety of stitching patterns and techniques may be used for not only affixing the fabric panels to one another, but also to provide reinforcement of fabric edges and other commonly employed garment features and a cosmetically pleasing appearance. For example, as best seen in
The upper end (556) and the majority of the length of left side (553B) of outer panel (552) are not affixed to the front panels (520, 540) or the side panels (560A, 560B). Instead, and as further described herein, the upper end (556) is adapted for releasable attachment to the upper front panel (520), and the left side (553B) of outer panel (552) is similarly adapted for releasable attachment to the upper and lower front panels (520, 540). In this manner, and as best seen in
Male snaps (557) are provided on the inner surface of outer panel (552), along the upper and left side edges (552, 553B) thereof. While snaps (557) may be secured to outer panel (552) in a variety of ways, in the depicted embodiment male snaps (557) are provided on strips of snap tape (558) which are secured (e.g., stitched) to the inner surface of outer panel (552). Mating female snaps (530) are provided on upper and lower front panels (520, 540), provided on strips of snap tape (531, 545) secured (e.g., stitched) to the upper and lower front panels (520, 540), respectively. A first strip of snap tape (531A) extends across the width of upper front panel (520), spaced upwardly away from the lower edge (522) of upper front panel (520). A second strip of snap tape (531B) extends downwardly from first strip (531A), generally parallel to, but spaced inwardly from the left side edge (524B) of upper front panel (520). In the embodiment shown, second strip of snap tape (531B) is spaced inwardly from the left side edge (524B) by a distance slightly greater than the width of the snap tape. A third strip of snap tape (545) extends downwardly from the upper edge (542) of lower front panel (540), generally parallel to, but spaced inwardly from the left side edge (544B) of lower front panel (540). Once again the third strip of snap tape (545) is spaced inwardly from the left side edge (544B) by a distance slightly greater than the width of the snap tape. As before, snap tape (531, 545) may be affixed to the front panels in a variety of ways, such as by stitching. In addition, the snap tape, and hence the female snaps (530) thereon, are arranged to align with the male snaps (557) on outer panel (552) such that the outer panel may be releasably attached to the front panels (520, 540) by the mating engagement of the male and female slaps.
One benefit of embodiments wherein the outer panel (552) is releasably attached to the upper and lower front panels by mating snaps is that the spacing between snaps may be selected such that, when the pocket (P) is closed, sufficient space is provided between adjacent pairs of snaps to allow catheter tubing (or other medical device conduits such as electrical leads) to exit the pocket between adjacent pairs of engaged snaps. This feature is best seen, for example, in
Upper and lower front panels (520, 540) are opened by simply pulling the panel from left to right across the front of a wearer. Once again, a variety of fasteners may be used for the releasable attachment of front panels (520, 540) to left side panel (560A) and the left shoulder portion of back panel (580), including conventional buttons (and corresponding button holes or loops), hook and bar fasteners, hook and loop fasteners (e.g., Velcro® brand), and mating snaps. In the embodiment shown, male and female snaps are once again used for releasable attachment of the front panels (520, 540), particularly non-metallic snaps so that the garment is MRI-compatible.
In the exemplary embodiment shown, male snaps (557) are provided on the inner surface of upper and lower front panels (520, 540), immediately adjacent the left side edges (524B, 544B) thereof. In the depicted embodiment male snaps (557) are provided on strips of snap tape (532) which are secured (e.g., stitched) to the inner surfaces of upper and lower front panels (520, 540), along the left sides thereof.
Mating female snaps (530) are provided on the outer surface of left side panel (560B), adjacent inner side edge (563B) thereof. Female snaps (530) are once again depicted as being provided on strips of snap tape (561) secured (e.g., stitched) to the left side panel (560B). A first strip of snap tape (561A) extends downwardly from the upper end of left side panel (560B), generally along the inner side edge (563B) to a point adjacent the vertical location of the access opening (i.e., the location of the lower edge (522) of upper front panel (520) when the upper front panel is in the closed position, e.g.,
A pair of rearwardly-facing male snaps (534) are also provided along the left upper end (525B) of upper front panel (520), as shown. A fabric strip (575) is affixed to the left shoulder portion (581B) of back panel (580) which extends over the left shoulder area of the garment. In the example shown, fabric strip (575) also includes a small piece of binding at neck opening (512). Forward-facing female snaps (574) are provided on fabric strip (575), as shown, and are arranged to align with the male snaps (534) such that left upper end (525B) of upper front panel (520) may be releasably attached to the left shoulder portion (581B) of back panel (580).
It will be understood that, not only may alternative fasteners besides male and female snaps be used for releasably attaching certain fabric panels to one another, the arrangement of male and female snaps may be changed, such as by providing male snaps on left side panel (560B) and mating female snaps on the rear surface of upper and lower front panels (520, 540).
One or more retention members are provided on the garment (510) for releasably retaining a portion of the medical device (e.g., catheter tubing or other conduit such as electrical leads) at a selected location on the outside of the garment. A variety of retention members may be employed, depending in part on the nature of the medical device desired to be retained as well as the configuration of the garment. For garments configured to be worn by infants and toddlers, for example, it may be desirable to provide one or more retention members on the back of the garment, out of reach of the child. For older children and adults, on the other hand, one or more retention members may be provided elsewhere on the garment for retaining a portion of a medical device extending from the garment pocket so that the portion of the medical device is less likely to interfere with daily activities of the wearer and/or to facilitate use of the medical device.
For example, in the case of a central venous catheter wherein the catheter tubing extends out of the garment pocket (P) between adjacent pairs of snaps (or other fasteners), not only is it desirable to retain the catheter tubing in a convenient, out-of-the-way location for attachment to an infusion pump, but also to locate the catheter tubing so that it is less likely to interfere with daily activities and less likely to be tugged upon or otherwise pulled (e.g., by snagging on something).
In the example garment (510) shown in
As best seen in
Shoulder straps (583) may be made of a variety of materials, particularly elastic (i.e., stretchable) fabrics such as woven, braided or knitted natural and synthetic fibers combined with an elastic material such as latex or rubber. In the example, shown shoulder straps (583) comprise braided polyester with latex or rubber for elasticity. By using an elastic material, shoulder straps (583) more securely retain catheter tubing (or other portions of a medical device) against the patient's shoulder in order to provide strain relief which, for example, prevents tugging or pulling on the exit wound of the catheter or which might otherwise cause a medical device conduit (e.g., electrical leads) to be disconnected from the patient or medical device unit. Shoulder straps (583) are also useful in maintaining the catheter tubing out of the way, particularly when the patient is in a supine or inclined position (e.g., for overnight infusion).
Like previously described embodiments, medical garment (510) of
Securement of anchor (586) within the pocket may be provided in a variety of ways, such as by using an adhesive, or using a hook and loop fastener arrangement wherein one of the hook or loop elements is affixed to the surface of one of the fabric panels within the pocket and the other is affixed to the tubing anchor (e.g., in place of adhesive (43) on anchor (40) in
The garment may also be configured to allow the tubing anchor to be removably secured within pocket (P) at more than one location. For example, when a snap fastening system is employed, snaps may be provided at two or more locations within the pocket (P), such as a snap (or set of snaps) located on upper front panel (520) above access opening (570) and a snap (or set of snaps) located on lower front panel (540) below access opening (570). Such an arrangement is shown in
In the embodiment of
Tubing anchor (586) may be configured like tubing anchor (440) described previously so as to include mating fastening features for selectively maintaining the tubing anchor in a closed position (e.g.,
Anchor (586) is secured within the pocket (P) by an anchor retainer. The anchor retainer in the exemplary embodiment comprises a sleeve (594) into which a portion of anchor (586) is inserted. In particular, sleeve (594) comprises a fabric loop (e.g., an elastic fabric such as that used for the shoulder straps) which is affixed to a panel of the garment within the pocket (P). In the exemplary embodiment, as best seen in
In order to secure tubing anchor (586) using the anchor retaining sleeve (594), the base member (587) of tubing anchor (586) is inserted into the anchor receiving chamber (595) such that the upper end portion of retaining sleeve (594) is positioned between the lower layer (592B) of the compressible lining and base member (587), as shown. The fit of base member (587) within anchor receiving chamber (595) is snug, with little or no vertical movement of the anchor and permitting only so much horizontal movement of the anchor as necessary for anchor installation and alignment. The snug fit helps to ensure that the anchor (586) will remain in its desired position and orientation, with the snug fit aided by using an elastic fabric for retaining sleeve (594).
Because anchor receiving chamber (595) extends generally parallel to the access opening (570) and is configured to locate the tubing anchor (586) adjacent the access opening (570), catheter tubing is able to pass through the access opening (570) directly into tubing anchor (586) between upper and lower layers (592A, 592B) of the compressible lining without the need for abrupt changes in direction of the tubing which might pinch or otherwise close off the tubing. In the exemplary embodiment shown, tubing anchor (586) and retaining sleeve (594) are configured such that the tubing-receiving region between the upper and lower layers (592A, 592B) of the compressible lining is positioned at or slightly below the vertical height of the access opening (570), such as less than 2 inches, or less than 1 inch below access opening (570). In addition, the entrance (E) (see
Of course it will be understood that retaining sleeve (594) (or other anchor retainer) may be located at a variety of other locations within the pocket (P), such as being affixed to upper front panel (520) (see
The use of garment (510) will now be described, with specific reference to a patient who already has a central venous catheter (C) in place in their upper chest region along with a plurality of catheter tubes (T) extending away from the external hub of the catheter (see
With the garment (510) opened as in
Next, the catheter tubing is positioned within the tubing anchor (586) in the manner described previously. If use of the catheter tubing is not necessary at that time, the catheter tubing extending from tubing anchor (586) is merely inserted into the pocket (P) such as by coiling the tubing in the manner depicted in
If use of the catheter tubing is necessary such as for the infusion of medication through the central venous catheter, the pocket is opened and the catheter tubing removed from the pocket (or at least as much as is necessary for infusion purposes). If desired, the tubing may be draped over one shoulder, beneath a shoulder strap (583), in order to maintain the tubing in a desired, out-of-the-way position, so as to minimize interference with, for example, other activities of the patient during infusion. Holding the tubing in a desired position using a shoulder strap (583) is also advantageous for infusion while the patient is sleeping, helping to avoid the tubing becoming entangled with the patient or other apparatus should the patient move.
Of course the length, depth and width of the pocket may be altered, as desired. For example, the garment may be configured such that the pocket extends from adjacent the neck opening all the way to the bottom edge of the garment (i.e., the waist opening of the garment). Similarly, the relative lengths of the upper and lower front panels (e.g., 520, 540) may be varied in order to alter the vertical location of the access opening.
For example, in some embodiments the pocket extends at least about 25% of the length of the garment (measured from shoulder, at neck opening (512), to bottom edge (513)), in other embodiments about 30-70% of the length of the garment, and in still other embodiments about 35-60% of the length of the garment. The vertical location of the access opening in some embodiments is below the arm openings (514), and in some embodiments within the upper half of the pocket. In still further embodiments, the vertical location of the access opening is between the lowermost extent of the arm openings (514) and the vertical center of the garment.
Instead of being configured as a shirt, however, garment (710) is configured as an infant or toddler bodysuit which covers the upper torso and at least a portion of the lower torso. In the embodiment shown in
Like garment (510), garment (710) also includes a pair of retention members on each shoulder of the garment, wherein the retention members comprise shoulder straps (783) which are constructed similar to shoulder straps (583) previously described. As seen in
In addition to access opening (870) provided between the lower edge of upper front panel (820) and the upper edge of lower front panel (840), a second access opening is provided in order to provide an additional location for a portion of a medical device (e.g., catheter tubing or electrical leads) to pass from beneath the garment and into the pocket (P3). In this example, the second access opening comprises a slot (871) provided in lower front panel (840), spaced below access opening (870) and lowermost anchor retainer (894). Slot (871) is simply an opening cut in lower front panel (840), reinforced around its periphery by stitching. Unlike access opening (870), second access opening (871) does not extend across the full width of the pocket (P3), and may be located at any height within the pocket, or even on upper front panel (820) instead of lower front panel. Also, two or more second access openings (i.e., in addition to access opening (870)) may be provided, as desired.
Fabric bag (811) is also included in the medical garment system shown in
In the embodiment of
In addition, additional pairs of mating snaps may be provided at one or more further locations within the pocket (P4), particularly when the pocket includes one or more second access openings like that in garment (810). Also, like all of the other snap attachments described herein, the male/female snap locations can be reversed (e.g., male snaps on front panels and female snaps on anchor (986)).
In the embodiment of
Because of the overlap of upper and lower front panels (1020, 1040), an additional snap (1033) is provided on the outer surface of lower front panel (1040), at the upper left corner thereof. Snap (1033) is located and configured for mating engagement with the lowermost snap (1057) on the rear surface of upper front panel (1020). Of course it will be understood that the overlap of the front panels can be reversed such that lower front panel (1040) overlaps upper front panel (1020), with an additional snap provided on the outer surface of the upper front panel for mating engagement with the uppermost snap on the rear surface of the lower front panel.
The various garments described and depicted herein can be made from any of a variety of fabrics, including those made from synthetic and/or natural fibers. Also, the same or different materials may be used for the various fabric panels. For example, in garment (510), back panel (580) comprises a mesh fabric, while the other panels (e.g., front, side and outer panels) comprise a jersey knit fabric. The mesh and jersey knit fabrics are moisture wicking, and are optionally antimicrobial (by choice of material and/or by treatment process). Alternatively, garment may be configured such that only selected portions are antimicrobial. For example, the fabric within the pocket (e.g., the upper and lower front panels and the outer panel) are antimicrobial, while other fabric panels are not.
While several devices and components thereof have been discussed in detail above, it should be understood that the components, features, configurations, and methods of using the devices discussed are not limited to the contexts provided above. In particular, components, features, configurations, and methods of use described in the context of one of the devices may be incorporated into any of the other devices. Furthermore, not limited to the further description provided below, additional and alternative suitable components, features, configurations, and methods of using the devices, as well as various ways in which the teachings herein may be combined and interchanged, will be apparent to those of ordinary skill in the art in view of the teachings herein.
By way of example, one modification of the garment shown in
Alternatively, the garment may be modified such that the access opening for an apheresis catheter comprises a slot (also referred to herein as a slit, particularly when formed by a single cut in a panel) formed in one of the front panels (520, 540) similar to slot (871) in
As yet another alternative, the outer panel, and hence the pocket and internal slit and anchor, can be located elsewhere on the garment besides being centered across the front width of the garment. For example, the outer panel forming the pocket may comprise a rectangular panel similar to that found on a conventional shirt, located adjacent the right and/or left clavicle region (e.g., less than about 5, or even 4, inches in height and less than about 4, or even 3, inches in width, positioned lateral to the front centerline of the garment). As yet another alternative, the outer panel forming the pocket may even be located on one or both sleeves of the garment in order to accommodate, for example, a PICC line.
Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
This application claims priority to U.S. Provisional Patent Application No. 62/039,360, filed on Aug. 19, 2014, entitled “Medical Garment.” The entire disclosure of the foregoing provisional patent application is incorporated by reference herein.
Number | Date | Country | |
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62039360 | Aug 2014 | US |