Sudden cardiac arrest accounts for more than 300,000 deaths in the United States alone, annually. Some of the high-risk population, such as post-myocardial infarction patients, that have implantable cardioverter defibrillators (ICD) have been shown in randomize trials to have a reduced mortality rate from those in the high-risk population that do not have ICDs.
However, there exists a population of patients who are not deemed appropriate candidates for ICDs for a variety of reasons but may still benefit from automatic external defibrillation. A wearable cardioverter defibrillator (WCD) is a device designed for patients at risk of sudden cardiac death (SCD) who are not immediate candidates for ICD therapy. The WCD is an external device including a fabric garment assembly that is fitted onto a patient's chest which holds electrodes in place and is capable of automatic detection and defibrillation of ventricular tachycardia (VT) or ventricular fibrillation (VF).
However, WCDs conventionally have been designed as unisex devices that may not be comfortable for a female patient's anatomy. Conventional WCDs generally required a female patient to either wear a bra over the WCD, which may result in discomfort, or forego a bra, which may lead to lack of support of the breasts of the female patient. Further, conventional WCDs often have loose wires that can get tangled in a patient's clothing and be uncomfortable for the patient.
This disclosure addresses these and other deficiencies of the prior art.
Aspects, features and advantages of embodiments of the present disclosure will become apparent from the following description of embodiments in reference to the appended drawings in which:
In general, embodiments of the disclosure relate to a wearable cardioverter defibrillator (WCD) including a supportive clothing article for including a belt, the belt including a first end with a first portion of a fastener and a second end with a second portion of the fastener, wherein the belt is structured to fasten around the torso of patient below the chest area of the patient, the belt including a first conductive mesh portion adjacent the first end of the belt or the second end of the belt, two straps, a back portion extending from the belt at an intermediary position on the belt to each of the two straps, the back portion including a conductive mesh, a first support receptacle attached to and extending from the belt and attachable to one of the two straps, and a second support receptacle attached to and extending from the belt and attachable to the other of the two straps.
Embodiments of the disclosure also relate to a wearable cardioverter defibrillator (WCD) including a supportive clothing article including a belt, having a two fabric layers construction, including a first side with a first portion of a fastener and a second side with a second portion of the fastener, wherein the belt is structured to fasten around the torso of patient below the chest area of the patient, the belt including a first conductive mesh portion on the inner layer adjacent the first side of the belt or the second side of the belt, two adjustable straps, a back portion, having a two fabric layer construction, extending from the belt at an intermediary position on the belt to each of the two straps, an inner layer of the back portion including a conductive mesh, and polyurethane tape attached to an end of the belt.
Embodiments of the disclosure also relate to a wearable cardioverter defibrillator (WCD) including a supportive clothing device having a supportive clothing article including a patient facing fabric layer, an outer fabric layer, an interior defined by the patient facing fabric layer and the outer fabric layer, the interior including, at least one electrical component, and a plurality of wires, at least one wire connected to the at least one electrical component.
The straps 106 of the convention WCD 100 often cut into the outer edge of the breasts of a female patient. Further, a female patient either must wear a bra to support the breasts over the conventional WCD 100, often a larger size bra than normal, or go without a bra. Female patients are often also unable to wear a preferred type of bra, such as an underwire bra, and the physical interference between the bra and the conventional WCD 100 can cause discomfort, such as pinching, to the female patient. The belt 102 of the conventional WCD 100 often rides up and cuts into the breast fold at the chest area of the female patient.
The supportive clothing article 300 includes an integrated belt 304 structured to wrap around a torso of the patient 302 below a chest area. The belt 304 may include a fastener, such as a snap fastener 306. Although a snap fastener 306 is shown in
The first and second breast support receptacles 312 start at the belt 304 and extend upwards, each toward a respective adjustable strap 314. The adjustable straps 314 may include ultrasonic bonded straps that have a number of loops 316 structured to receive hooks 318 located at the top of the breast support receptacles 312. The straps 314 are adjustable by selecting the desired loop 316 in the strap 314 to connect the hook 318. The lower the loop 316 used, the longer the strap 314 will be on the patient 302. While bonded loop shoulder straps 314 are shown, one of ordinary skill in the art will readily understand that other types of adjustable or non-adjustable (such as elastic) straps may be used. For example, a tri-glide strap may be used in the front of device, instead of the bonded loops and hooks.
Each breast support receptacle 312 may have a generally triangular shape, as shown in
Snaps 320 may be located on one or both of the breast support receptacles 312. The snaps 320 are structured to mate with a matching snap located on a user device that connects to the defibrillator, such as an alert button. The supportive clothing article 300 may also include one or more flaps 322 that hold the cable(s) for the user device in place. The flaps 322, for example, may snap to the breast support receptacles 312 so that they may be opened to insert the cord(s) and then closed to hold the cord(s) in place. In other embodiments, the flaps 322 may be connected via a button or a hook and loop fastener, or the flaps 322 may be elastic and extend to receive the user device and cords through the flaps 322.
As seen in
The supportive clothing article 300 also includes a back portion 326 structured to extend from the belt 304 to the straps 314. As seen in
The back portion 326 may include cable guides 328, 330, 332, and 334, to align the cable(s) from the electronic module to the user device along the spine and the shoulders of the patient 302. The cable guides 328, 330, 332, and 334 may be elastic loops to keep the wires in place along the spine of the patient 302. In other embodiments, the cable guides 328, 330, 332, and 334 may be removable to add the cable, such as with a snap fastener, and then reattached over the cable. This keeps the cables routed over the spine instead of over the shoulder blades, which provides comfort to the patient 302 when seated. Because of the natural depression in the spine of the patient 302, the cables can more comfortably sit in this area. That is, the cable(s) may be secured between cable guides 332 and 334, and then may be secured around the shoulder of the patient 302 using either cable guide 328 or 330. Cable guides 328, 330, 332, and 334 may also be included in a male or unisex version of a supportive clothing article.
A pocket or opening 336 may be provided at the top of the belt 304 that abuts the back portion 326. The pocket or opening 336 may include a fastener 338 to close the pocket or opening 336. Further, a pocket or opening 340 may also be provided along the belt 304 near the male components 308 of the snap fastener 306, along with another fastener 338. The pockets and openings 336 and 340 may be used to place electrical components and/or wires within the supportive clothing article 300, which will be discussed in more detail below with reference to
In some embodiments, the supportive clothing article 300 may be constructed with a double fabric layer construction, as shown in
Although not shown in
Similar to
Starting from the positions discussed above, the breast support receptacles 612 extend upward from the belt 604 toward a respective adjustable strap 614, having the loops 616 and hooks 618 discussed above, or any other alternative discussed above.
Snaps 320 may be located on one or both of the breast support receptacles 312. The snaps 320 are structured to mate with a matching snap located on a user device that connects to the defibrillator, such as an alert button. The supportive clothing article 300 may also include one or more flaps 322 that hold the cable(s) for the user device in place. The flaps 322, for example, may snap to the breast support receptacles 312 so that they may be opened to insert the cord(s) and then closed to hold the cord(s) in place. In other embodiments, the flaps 322 may be connected via a button or a hook and loop fastener, or the flaps 322 may be elastic and extend to receive the user device and cords through the flaps 322.
As seen in
The supportive clothing article 600 also includes a back portion 626 structured to extend from the belt 604 to the straps 614. The back portion 626 may extend into the belt 604. That is, the belt 604 includes a straight hem at a bottom portion of the belt 604, and a curved hem from the top portion of the belt, the top portion curving upwards from the snap fastener on each side. The belt 604 includes a portion that is located between the breast receptacle 612 and the back portion 626 on each side, in an area corresponding to an underarm area of the patient 602.
Similar to
A pocket or opening 636 may be provided at the top of the belt 604 that abuts the back portion 626. The pocket or opening 636 may include a fastener 638 to close the pocket or opening 636. Further, a pocket or opening 640 may also be provided along the belt 604 near the male components 608 of the snap fastener 606, along with another fastener 638. The pockets and openings 636 and 640 may be used to place electrical components and/or wires within the supportive clothing article 600, which will be discussed in more detail below with reference to
Both the inner layer 500 and the outer layer 502 of the breast support receptacles 612 are gathered at the bottom seam 642 near the belt 604. Each breast receptacle 612 may include an opening 644 structured to receive a bra cup insert (not shown), in various sizes, to provide additional support for the breasts of a female patient. That is, the opening 644 allows the bra cup insert to be placed between the inner fabric layer 500 and the outer fabric layer 502.
In some embodiments, both the inner layer 500 and the outer layer 520 are the same fabric, such as, for the entirety of the supportive clothing article 300 may be made of the same fabric or the entire outer layer may be made of the same fabric, such as a thin, soft, and stretchy fabric, such as Sensitive® Plus fabric, available from EUROJERSEY S.P.A. For example, using industry standard testing, the fabric should exhibit at least a 125% increase in width and a 105% increase in length when subjected to a 15 Newtons (N) force, and at least a 175% increase in width and a 120% increase in length when subjected to a 35N force. In some embodiments, each fabric layer is a wicking fabric to keep the patient dry and comfortable.
In some embodiments, different components of the supportive clothing article 300 include different fabric types. For example, the belt 604 may include a first fabric on the outer layer 500 portion of the belt 604 that includes the male components 608 of the fastener 606 until the opening 640, that includes stretch recovery materials, such as Sensitive® Sculpt fabric, also available from EUROJERSEY S.P.A. For example, using industry standard testing, the fabric should exhibit at least a 110% increase in width and an 85% increase in length when subjected to a 15 Newtons (N) force, and at least a 160% increase in width and a 110% increase in length when subjected to a 35N force. This portion of the belt 604 may also include a foam layer between the inner layer 500 and the outer layer 502. The remainder of the outer layer 502 of the belt 604 is constructed of the Sensitive® Plus fabric.
The inner layer 500 of the belt 604 may be constructed of the Sensitive® Sculpt fabric as well, as the high recovery aspect of this material provides pressure on the electrodes, discussed in more detail below, against the body of the patient. However, a portion of the inner layer 500, as seen in
The outer layer 502 of the back portion 626 may include the Sensitive® Sculpt fabric, to maintain pressure on a conductive mesh portion 648 provided on the inner layer 500 of the back portion 626. The remaining material at the top portion above the conductive mesh portion 648 may also be the Sensitive® Sculpt fabric to provide additional pressure to the conductive mesh portion 648. In some embodiments, a foam and/or spacer mesh may be added between the outer layer 502 and the conductive mesh 646 and 648 to further provide pressure to conductive mesh 646 and 648, as well as improve gel transmission, discussed below. The conductive meshes 646 and 648 may be any conductive mesh that acts as an electrode during a defibrillation procedure, as discussed below, such as the conductive mesh 800 shown in
The conductive silver mesh 800 in
As seen in
The supportive clothing article 600 may also include stabilizer tape (not shown) located between the two fabric layers 500 and 502 within the back portion 626, extending from the top hem 656. The back portion 626 may also include inserted stabilizer tape. The fabric of both the inner layer 500 and outer layer 502 at the top hem 656 may be gathered. The gathered hem 656, as well as the elastic seams, maintain contact between the mesh portion 644 and the back of the patient by pulling in the garment toward the back of the patient. The bottom hem 650 also include a thin strip of polyurethane tape or stabilizer tape to pull the lower edge of the defibrillator electrode(s) against the skin of the patient 302.
Further, a smooth and supportive sateen tape 642 may be provided at the hem under each of the breast support receptacles 612, to provide additional support for the breasts of the patient. In some embodiments, the breast support receptacles 612 and the back portion 626 may include polyurethane tape sandwiched inside the binding at the edges and the seams include a zigzag stitch on the binding. Polyurethane tape 660 may also be included on the inner layer 500 of the belt portion 604 to assist in keeping the belt 604 properly position on the body of the patient during wear, as well as at the upper hem 656.
In some embodiments, wires for the various electrodes that may attach to the belt 304 may be contained between or within the inner fabric layer 500 and the outer fabric layer 502. Such a feature may be used on a clothing supportive article may be the clothing supportive article discussed above, or may be a unisex clothing supportive article that does not contain, for example, breast support receptacles 312.
Similar to
All of the features discussed above, with the exception of the breast receptacles 312 and 612, may be provided on a unisex and/or male version of a supportive clothing article for better performance of a unisex and/or male version of the supportive clothing article.
As illustrated in
The cross-section view of
The supportive clothing article 900 may also include a receptacle 910 that is recessed from the outer layer 902 and structured to receive an electronics module (not shown) for the defibrillator. The receptacle 910 may be attached to the outer layer 902 or may be removable. The receptacle 910 may be a hard plastic, or other similar material. When the electronics module is not with in the receptacle 910, the supportive clothing article 900 may be washed, etc. The receptacle 910, may correspond, for example, to pocket 402 in the supportive article 300 of
The receptacle 910 includes electrical contacts 912 that electrically connect to electrical contacts on the electronics module. Each of the electrical contacts 912 may be connected to a wire, such as one of wires 914, 916, 918, and 920. Wires 914, 916, 918, 920, and 922 are within the interior 906 of the supportive clothing article 900 and may be connected to the various electrical components 908 and 912. For example, a wire 918 may be connected to one of the electrical contacts 912 and the electrode 908. Then, either an additional wire 922 may continue one from electrode 908, as illustrated in
Wires 914-922 may be disposed in a serpentine manner so that wires 914, 916, 918, 920, and 922 may unfold as the fabric layers 902 and 904 stretch when worn by a patient. That is, additional wire is provided within the interior 906 such that when the fabric layers 902 and 904 are not stretched, the wires 914, 916, 918, 920, and 922 are contorted, and when the fabric layers 902 and 904 are stretched, the wires 914, 916, 918, 920, and 922 then straighten out, depending on how far the fabric layers 902 and 904 are stretched. In some embodiments, wires 914-922 may be attached to the insides of either outer layer 902 or inner layer 904, or both, in any manner of way to permit unfolding of the wires 914-922. For example, as seen in
While a single electrode is shown in
Aspects and examples of the present disclosure operate with various modifications and in alternative forms. Specific aspects have been shown by way of example in the drawings and are described in detail herein below. However, it should be noted that the examples disclosed herein are presented for the purposes of clarity of discussion and are not intended to limit the scope of the general concepts disclosed to the specific examples described herein unless expressly limited. As such, the present disclosure is intended to cover all modifications, equivalents, and alternatives of the described aspects in light of the attached drawings and claims.
References in the specification to embodiment, aspect, example, etc., indicate that the described item may include a particular feature, structure, or characteristic. However, every disclosed aspect may or may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same aspect unless specifically noted. Further, when a particular feature, structure, or characteristic is described regarding a particular aspect, such feature, structure, or characteristic can be employed in connection with another disclosed aspect whether or not such feature is explicitly described in conjunction with such other disclosed aspect.
Illustrative examples of the technologies disclosed herein are provided below. An embodiment of the technologies may include any one or more, and any combination of, the examples described below.
Example 1 is a supportive clothing article for a wearable cardioverter defibrillator (WCD), comprising a belt, the belt including a first end with a first portion of a fastener and a second end with a second portion of the fastener, wherein the belt is structured to fasten around the torso of patient below the chest area of the patient, the belt including a first conductive mesh portion adjacent the first end of the belt or the second end of the belt; two straps; a back portion extending from the belt at an intermediary position on the belt to each of the two straps, the back portion including a conductive mesh; a first support receptacle attached to and extending from the belt and attachable to one of the two straps; and a second support receptacle attached to and extending from the belt and attachable to the other of the two straps.
Example 2 is the supportive clothing article of example 1, wherein each of the first support receptacle and the second support receptacle are generally triangular shaped.
Example 3 is the supportive clothing article of example 1 or 2, wherein each of the belt, the back portion, the first support receptacle and the second support receptacle have a two fabric layer construction.
Example 4 is the supportive clothing article of example 3, wherein an outer layer of the two fabric layer construction of the belt includes an opening structured to receive an electronic device.
Example 5 is the supportive clothing article of example 4, wherein the opening is located at the intermediary position on the belt.
Example 6 is the supportive clothing article of any one of examples 3-5, wherein the first support receptacle and the second support receptacle each include an opening between an outer layer and an inner layer of the two fabric layer construction, the opening structured to receive a breast support article.
Example 7 is the supportive clothing article of any one of examples 3-6, wherein an outer layer and an inner layer of the two layer fabric construction for the first support receptacle and the second support receptacle are the same type of fabric.
Example 8 is the supportive clothing article of any one of examples 3-7, wherein an outer layer of the two layer fabric construction of the belt and the back portion is a first fabric and an inner layer of the two layer fabric construction of the belt and the back portion is a second fabric different from the first fabric.
Example 9 is the supportive clothing article of any one of examples 1-8, wherein the fastener of the belt includes a snap fastener, a hook and eye fastener, a hook and loop fastener, or a button fastener.
Example 10 is the supportive clothing article any one of examples 1-8, wherein a length of the two straps are adjustable.
Example 11 is the supportive clothing article of example 10, wherein each of the two straps include a plurality of loops, and an end of each of the first support receptacle and the second support receptacle includes a hook structured to attach to one of the plurality of loops to adjust the length of the two straps.
Example 12 is the supportive clothing article of any one of examples 1-11, wherein the first supportive receptacle and the second supportive receptacle each include stabilizer tape at the portion of the respective first and second supportive receptacle that attaches to the belt.
Example 13 is the supportive clothing article of any one of examples 1-12, further comprising a first cable guide attached to an end of the back portion and a second cable guide attached to the end of the back portion.
Example 14 is the supportive clothing article of example 13, wherein the first cable guide and the second cable guide are elastic.
Example 15 is the supportive clothing article of any one of examples 1-14, the belt including a first fabric layer and a second fabric layer, and an interior defined by the first fabric layer and the second fabric layer, the interior including at least one electrical component; and a plurality of wires, at least one wire connected to the at least one electrical component.
Example 16 is the supportive clothing article of any one of examples 1-15, further including polyurethane tape directly above and below the conductive mesh of the back portion.
Example 17 is the supportive clothing article of any one of examples 1-6, further including polyurethane tape along a bottom portion of the belt.
Example 18 is a supportive clothing article for a wearable cardioverter defibrillator (WCD), comprising a belt, having a two fabric layers construction, including a first side with a first portion of a fastener and a second side with a second portion of the fastener, wherein the belt is structured to fasten around the torso of patient below the chest area of the patient, the belt including a first conductive mesh portion on the inner layer adjacent the first side of the belt or the second side of the belt; two adjustable straps; a back portion, having a two fabric layer construction, extending from the belt at an intermediary position on the belt to each of the two straps, an inner layer of the back portion including a conductive mesh; and polyurethane tape attached to an end of the belt.
Example 19 is the supportive clothing article of example 18, wherein an outer layer of the two fabric layers of the belt includes an opening structured to receive an electronic device.
Example 20 is the supportive clothing article of example 19, wherein the opening is located at the intermediary position on the belt.
Example 21 is the supportive clothing article of any one of examples 18-20, wherein an outer layer of the two layer fabric construction of the belt and the back portion is a first fabric and an inner layer of the two layer fabric construction of the belt and the back portion is a second fabric different from the first fabric.
Example 22 is the supportive clothing article of any one of examples 18-21, wherein the fastener of the belt includes a snap fastener, a hook and eye fastener, a hook and loop fastener, or a button fastener.
Example 23 is the supportive clothing article of any one of examples 18-22, wherein a length of the two straps are each adjustable.
Example 24 is the supportive clothing article of example 23, wherein each of the two straps include a plurality of loops, and the proximal end of each of the first support receptacle and the second support receptacle includes a hook structured to attach to one of the plurality of loops to adjust the length of the two straps.
Example 25 is the supportive clothing article of any one of examples 18-24, further comprising a first cable guide attached to a proximal end of the back portion and a second cable guide attached to an end of the back portion.
Example 26 is the supportive clothing article of example 25, wherein the first cable guide and the second cable guide are elastic.
Example 27 is the supportive clothing article of any one of examples 18-26, wherein the back portion includes a gathered hem at a proximal end.
Example 28 is the supportive clothing article of any one of examples 18-27, the belt including a first fabric layer and a second fabric layer, and an interior defined by the first fabric layer and the second fabric layer, the interior including: at least one electrical component; and a plurality of wires, at least one wire connected to the at least one electrical component.
Example 29 is the supportive clothing article of any one of examples 18-28, further including polyurethane tape directly above and below the conductive mesh of the back portion.
Example 30 is the supportive clothing article of any one of examples 18-29, further including polyurethane tape at an end of the belt.
Example 31 is a supportive clothing article for a wearable cardioverter defibrillator (WCD), comprising a patient facing fabric layer; an outer fabric layer; an interior defined by the patient facing fabric layer and the outer fabric layer, the interior including: at least one electrical component; and a plurality of wires, at least one wire connected to the at least one electrical component.
Example 31 is the supportive clothing article of example 31, wherein the electrical component is an electrode.
Example 33 is the supportive clothing article of example 32, wherein the electrode is disposed in the outer fabric layer and is structured to contact skin of a patient.
Example 34 is the supportive clothing article of example 32, wherein the electrode electrically contacts skin of a patient through the outer fabric layer.
Example 35 is the supportive clothing article of any one of examples 31-34, further including a plurality of electrical components.
Example 36 is the supportive clothing article of example 35, wherein the plurality of electrical components includes an electrode and an electrical contact to electrically connect to a removable electronics module.
Example 37 is the supportive clothing article of any one of examples 31-36, wherein the plurality of electrical wires are disposed in the interior in a serpentine fashion.
Example 38 is the supportive clothing article of any one of examples 31-37, wherein the plurality of electrical wires are attached to one of the first layer or the second layer.
The previously described versions of the disclosed subject matter have many advantages that were either described or would be apparent to a person of ordinary skill. Even so, these advantages or features are not required in all versions of the disclosed apparatus, systems, or methods.
Additionally, this written description makes reference to particular features. It is to be understood that the disclosure in this specification includes all possible combinations of those particular features. Where a particular feature is disclosed in the context of a particular aspect or example, that feature can also be used, to the extent possible, in the context of other aspects and examples.
Also, when reference is made in this application to a method having two or more defined steps or operations, the defined steps or operations can be carried out in any order or simultaneously, unless the context excludes those possibilities.
Although specific examples of the disclosure have been illustrated and described for purposes of illustration, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, the disclosure should not be limited except as by the appended claims.
This application is a continuation of U.S. patent application Ser. No. 15/889,040, filed Feb. 5, 2018, now U.S. Pat. No. 10,926,080, issued Feb. 23, 2021, which claims priority from U.S. Provisional Patent Application No. 62/443,686, filed Jan. 7, 2017, and claims priority from U.S. Provisional Patent Application No. 62/454,784, filed Feb. 4, 2017, and claims priority from U.S. Provisional Patent Application No. 62/556,693, filed Sep. 11, 2017.
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