Lifestyle weatherproof wearable bag for ventricular assist device

Embodiments provide a water-resistant VAD lifestyle bag including a removable strap connected to two connectors along the top of the bag, a lower unit having two curved top edges connected to two connectors and having at least one water bottle pocket to contain water bottles and a front pocket cover flap, a zipper configured along the top of the lower unit, an emergency information window made of clear material to view the status of a VAD device, a plurality of pockets built into the back of the bag, at least one credit card pocket built into the bag, a VAD controller pocket having clips and configured to secure a VAD controller, and at least one VAD battery pocket having clips and fitted to house at least one VAD battery for powering the VAD device. The plurality of pockets is configured to secure pens, phones, and snacks.

BACKGROUND

Field

Embodiments generally relate to a water-resistant bag for storing a medical electronic device. More specifically, the invention relate to a water-resistant ventricular assist device (VAD) bag for carrying VAD devices, such as HeartWare® or HeartMate® devices, including, for example, HeartWare® or HeartMate® controllers and batteries, in showers or inclement weather conditions.

Description of the Related Art

Cardiac arrest and other cardiac health ailments are a major cause of death worldwide. Heart failure happens when the heart does not pump enough blood to meet the needs of a human body, causing fluid to build up in the lungs and body. Sometimes the heart becomes so weak that medicine cannot improve the symptoms. Often the only treatment option is a VAD.

VADs are mechanical pumps implanted into a human chest. VADs take over the pumping action of the area of the heart called the ventricle. VADs help a heart pump so that a person becomes stronger. A VAD system utilizes a centrifugal blood pump that is implanted into pericardial space for ventricular support. A percutaneous driveline connects the VAD mechanical pump to an external controller, which regulates the pump function and is powered by one or more batteries.

The use of VADs provides patient benefits in most conditions. The presence of water or moisture in contact with VADs is undesirable for many reasons. Water or moisture destroys electrical function of the VAD pumps and of the battery in a VAD system. Further, water or moisture partially or completely clogs components of the controller and is abrasive to components within the VAD pump. In addition, the constant or daily presence of water leaves rust on VAD system components, resulting in gradual wear and tear.

The restricted use of VADs in water environments or moisture conditions limits their benefits. VADs are not suitable for use in showers or in inclement weather. Plastic bags that cover VADs during showers or inclement weather are flimsy or do not provide adequate protection. Multiple plastic bags are oftentimes used to cover multiple components of the VAD system. Such plastic bags do not adequately seal compartments and components of the VAD system and do not properly position other lifestyle items. Further, plastic bag do not protect VAD devices from water and other debris that may stop the device from working while the wearer is in inclement weather.

Various kinds of backpacks or shoulder bags are available to protect a wearable component from water during various activities outside. These backpacks or shoulder bags are not designed for use with VAD devices and do not improve patient comfort and mobility while outside using the VAD device. Generally, bags are not custom designed for VADs and do not provide enough protection for the VAD, its controller, or batteries, while a patient is showering. Backpacks and shoulder bags can hold VAD devices, but are limited in restricting patient comfort and mobility while in the shower and using a VAD device. Such bags do not allow the user to quickly access the controls of a VAD system and replace the batteries. Such backpacks and shoulder bags are often bulky and do not have enough pockets to accommodate various VAD system components.

It is thus desirable to have a VAD bag that can quickly and easily be accessed and also one that provides water, moisture, and debris protection for the electronics contained in the bag itself while the user is in the shower or experiencing inclement weather. Further, it is desirable to have a VAD bag that allows the user to quickly access the controls and replace the batteries, and also one that provides protection for the electronics contained in the bag itself while the user is experiencing inclement weather. Accordingly, what is needed is a water-resistant bag for storing and protecting VAD devices, its controller, and batteries.

SUMMARY

Embodiments relates to a water-resistant VAD lifestyle bag, a water-resistant VAD lifestyle system, and a method of making a water-resistant VAD lifestyle bag for storing a VAD sensitive to water damage. More specifically, embodiments relates to a water-resistant VAD lifestyle bag including a removable strap connected to two connectors along the top of the bag and having a shoulder pad, a lower unit having two curved top edges connected to two connectors and having at least one water bottle pocket to contain water bottles of various shapes and a front pocket cover flap, a zipper configured along the top of the lower unit, an emergency information window made of clear material to view the status of a VAD device, a plurality of pockets built into the back of the bag, at least one credit card pocket built into the bag, a VAD controller pocket having clips and configured to secure a VAD controller, and at least one VAD battery pocket having clips and fitted to house at least one VAD battery for powering the VAD device. The plurality of pockets is configured to secure at least one of pens, phones, and snacks. The VAD controller pocket is configured to block entry of moisture to the VAD controller. The VAD battery pocket is configured to block entry of moisture to the at least one VAD battery. The VAD controller pocket and the at least one VAD battery pocket is outlined with polypropylene piping with a ⅛ inch polypropylene cord, lined with waterproof lining of 200 Denier Oxford Coated DWR fabric, and contains a styrene insert to maintain the firm shape of the bag. The at least one water bottle pocket is constructed of 1,000 Denier Nylon Cordura Coated DWR 1stFabric and having a plastic inserted of 0.25 inch thick plastic. The emergency information window is constructed of 30,000 super clear plastic and with a zipper chain of 8 inches length. The plurality of pockets is constructed of 1,000 Denier Oxford Coated DWR 1stfabric and optionally sewn over with water-resistant lining fabric.

Another embodiment provides a water-resistant VAD lifestyle bag that is 12 inches long at the top of the bag, 13.5 inches high, 11 inches long at the bottom of the bag or is 14.25 inches long at the top of the bag, 11.5 inches high, and 11.5 inches long at the bottom of the bag, and with a 2 inches seam ending at the top of the bag. In some embodiments, the water-resistant VAD lifestyle bag provides at least one belt loop sewn onto the back of the bag for holding onto a belt and with seams 2.25 inches apart and made of P 2,200 with 2,000 webbing with UV inhibitors or a sewn extra pocket 4.75 inches by 2.25 inches coupled with a zipper onto the back of the bag. The emergency information window is 6.5 inches by 6.5 inches. The VAD battery pocket is 4.25 inches by 3.25 inches by 1.75 inches. The plurality of pockets further includes at least one of a pen pocket 0.25 inch by 6 inches, a phone pocket of 5.25 inches by 7.25 inches, and a snack pocket 7 inches by 4 inches. The at least one water bottle pocket includes a bottom hole of ⅝ inch and is 6 inches tall by 7 inches around. The at least one credit card pocket includes a first credit card pocket 5 inches by 2.25 inches, a second credit card pocket 4.75 inches by 2.25 inches, a third credit card pocket 4.25 inches by 2.25 inches, a fourth credit card pocket 4⅜ inches by 2.25 inches, and a fifth credit card pocket 4.25 inches by 2.25 inches. The removable strap is 56 inches in length. The zipper is a #8 zipper chain of 10 inches long or a #10 zipper chain of 12 inches long, with water-resistant lining fabric. The bag exterior of the bag is constructed of a double layer, water-resistant lining fabric with a foam inserted between the lining fabric layers to create firmness and maintain shape, wherein the foam is ⅛ inch polypropylene, dust-free, non-abrasive, shock resistant and moisture proof sewn with German Thread Strongbond 40-T70 V69 and Serabond 30-T90-V92 with up to 12 stiches per inch.

According to at least one embodiment, the water-resistant VAD system includes a water-resistant VAD lifestyle bag and a water-resistant percutaneous lead for electrically coupling the VAD controller to a VAD pump and for regulating VAD pump function. In some embodiments, the water-resistant VAD system further includes an external display device for presenting performance of the water-resistant VAD lifestyle system or for providing touch input to the controller operating parameters.

According to at least one embodiment, the method of making a water-resistant VAD lifestyle bag for storing a VAD device sensitive to water damage including providing a removable strap connected to two connectors along the top of the bag and having a shoulder pad, providing a lower unit having two curved top edges connected to two connectors and having at least one water bottle pocket to contain water bottles of various shapes and a pocket cover flap, closing the VAD controller pocket with the clips, and closing the VAD battery pocket with the clips.

DETAILED DESCRIPTION

The foregoing aspects, features, and advantages of the various embodiments will be further appreciated when considered with reference to the following description of preferred embodiments and accompanying drawings, wherein like reference numerals represent like elements. The following is directed to various exemplary embodiments of the disclosure. The embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, those having ordinary skill in the art will appreciate that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to suggest that the scope of the disclosure, including the claims, is limited to that embodiment. Like numbers refer to like elements throughout. In an embodiment, usage of the term “about” includes +/−5% of the cited magnitude. In an embodiment, usage of the term “substantially” includes +/−5% of the cited magnitude.

For simplicity and clarity of illustration, the drawing figures illustrate the general manner of construction, and descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the discussion of the described embodiments of the invention. Additionally, elements in the drawing figures are not necessarily drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments. Like reference numerals refer to like elements throughout the specification. Hereinafter, various embodiments will be described in detail with reference to the accompanying drawings.

FIG. 1is a full view of the water-resistant VAD lifestyle bag100for use in a shower104or in inclement weather106by a patient102. A water-resistant VAD lifestyle system103, which may include a VAD pump105, a water-resistant percutaneous lead107, a water-resistant VAD lifestyle bag100, a VAD controller138(shown inFIG. 3A), and one or more VAD batteries144(shown inFIG. 3AandFIG. 3C), may be used to maintain blood to the patient102while in a wet environment. Thus, for example, the function of the water-resistant VAD lifestyle system103is maintained while the patient102partakes in daily activities that may involve exposure to water, moisture, or debris in the external environment. In some embodiments, the water-resistant percutaneous lead107and water-resistant VAD bag100protect internal electrical components from the water in any wet environment. In certain embodiments, the water-resistant VAD lifestyle system may include an external display device for presenting performance of the water-resistant VAD lifestyle system103or for providing touch input to the controller operating parameters by a patient102.

As shown, the water-resistant percutaneous lead107, which electrically couples the VAD controller (shown inFIG. 3A) to the VAD pump105and which regulates the VAD pump105function, may be waterproof or covered with a water-resistant material. The VAD pump105, which may be a centrifugal blood pump that is implanted into pericardial space for ventricular support, is located inside of the patient102and is not exposed to water. In some embodiments, for example, the water-resistant VAD lifestyle bag100, when coupled together with the water-resistant percutaneous lead107and the VAD pump105provides water resistance to the entire water-resistant VAD lifestyle system103for use in a shower104or in inclement weather106. Thus, for example, a patient102can comfortably shower or remain mobile while still utilizing the exemplary water-resistant VAD lifestyle system103of the various embodiments.

As shown in the close-up of the heart region101, the VAD pump105may be a HeartMate® II Blood Pump or a Heartware® Blood Pump. In certain embodiments, a pacemaker or a Heartware® monitor may take the place of the VAD pump105. The Heartware® VAD pump105, which may be a new generation HVAD centrifugal flow VAD, is smaller device than the HeartMate® II VAD pump105. In some embodiments, the larger HeartMate® II device requires a VAD controller138(shown inFIG. 3A) and a VAD battery144(shown inFIG. 3AandFIG. 3C) that is taller than the their equivalent components in a Heartware® VAD pump105. In accordance, the water-resistant VAD lifestyle bag100utilized for the HeartMate® II Blood Pump or a Heartware® Blood Pump will differ in dimensions.

The VAD pump105may be implanted alongside a patient's102heart's left ventricle or may be placed just below the diaphragm in the abdomen. The VAD pump105may be attached to the aorta and leave natural circulation in place while providing all of the energy necessary to propel blood throughout the patient's102body. In certain embodiments, the VAD pump105may pump up to 10 liters of blood per minute covering the full output of a healthy heart, and provide long-term cardiac support for patients who have advanced-stage heart failure. In some embodiments, the VAD pump105is about 55 cubic centimeters and about 160 grams and includes an impeller that is suspended through a combination of passive magnetic and hydrodynamic forces.

Shown inFIG. 2Ais a front view of the water-resistant VAD lifestyle bag100according to at least embodiment. The water-resistant VAD lifestyle bag100includes a removable strap108connected to two connectors112along the top of the bag100, a lower unit111having two curved top edges connected to two connectors112and having at least one water bottle pocket120to contain water bottles122of various shapes and a front pocket cover flap118, a zipper124configured along the top of the lower unit111, an emergency information window134made of clear material to view the status of a VAD device132, a plurality of pockets158built into the back of the bag100(shown inFIG. 4B), at least one credit card pocket160built into the bag100(shown inFIG. 4B), a controller pocket140having clips141and configured to secure a VAD controller138(shown inFIG. 3AandFIG. 3B), and at least one battery pocket142having clips141and fitted to house at least one VAD battery144for powering the VAD device132(shown inFIG. 3AandFIG. 3C). The VAD device132may be a HeartMate® VAD or a Heartware® VAD, which may be coupled to a VAD pump105. The plurality of pockets158is located on the backside, which may be the side not having the front over pocket114, of the water-resistant VAD lifestyle bag100. In certain embodiments, the exterior of the water-resistant VAD lifestyle bag100is constructed of a double layer, water-resistant lining fabric with a foam inserted between the lining fabric layers to create firmness and maintain shape, wherein the foam is ⅛ inch polypropylene, dust-free, non-abrasive, shock resistant and moisture proof sewn with German Thread Strongbond 40-T70 V69 and Serabond 30-T90-V92 with up to 12 stiches per inch.

In certain embodiments, the water-resistant VAD lifestyle bag100is lined with a bag webbing126, which may be 1 inch thick and may outlined and bind to the bag100. In some embodiments, the water-resistant VAD lifestyle bag100is 12 inches long at the top of the bag, 13.5 inches high, 11 inches long at the bottom of the bag or is 14.25 inches long at the top of the bag, 11.5 inches high, and 11.5 inches long at the bottom of the bag, and with a 2 inches seam ending at the top of the bag. In certain embodiments, the water-resistant VAD lifestyle bag100includes a zipper124that is a #8 zipper chain of 10 inches long or a #10 zipper chain of 12 inches long, with water-resistant lining fabric. In certain embodiments, the emergency information window134is 6.5 inches by 6.5 inches, is constructed of 30,000 super clear plastic, and is surrounded by an emergency information window frame136that may be of a water-resistant lining material. In some embodiments, the at least one water bottle pocket120is constructed of 1,000 Denier Nylon Cordura Coated DWR 1stFabric and has a plastic inserted of 0.25 inch thick plastic.

Shown inFIG. 2Bis a view of the removable strap108of the water-resistant VAD lifestyle bag100according to an embodiment. A shoulder pad110may slide onto or be attached to the removable strap108, and may be prevented from being removed from the removable strap108by the two connectors112. In some embodiments, the removable strap is 56 inches in length.

Shown inFIG. 2Cis a close-up view of shoulder pad110of the removable strap108, which may be about 1 inch wide, of the water-resistant VAD lifestyle bag according to an embodiment. The shoulder pad100contains holes109which enable the removable strap108to snugly be coupled to the shoulder pad. Thus, for example, the hole109may be about 1 inch wide, and allow an about 1 inch wide removable strap to fit inside. Each hole109is sized to enable the shoulder pad110to slide along the removable strap108but not oversized to cause unnecessary motion of the removable strap108.

Shown inFIG. 3Ais an internal view of the water-resistant VAD lifestyle bag100with an open front cover pocket114according to an embodiment. The front cover pocket114may be opened by a patient102lifting the front pocket cover flap118away from the water-resistant lifestyle VAD bag100. The emergency information window134allows a patient102to view indicators on at least one of the VAD device132, VAD controller138, and VAD battery144. A patient may lift up the front cover pocket114to view more than the indicators, such as for example the full view or full operation, of each of the VAD device132, VAD controller138, and VAD battery144.

In certain embodiments, at least one of the VAD device132, VAD controller138, and VAD battery144may be attached to the water-resistant VAD lifestyle bag100with a hook133, which is mated with a hole on the pockets that enclose the VAD device132, VAD controller138, and VAD battery144. Thus, for example, a VAD device pocket131, which may enclose the VAD device132, may be coupled to the water-resistant VAD lifestyle bag100with a hook133. Thus, for example, the VAD controller pocket140, which may enclose the VAD controller138, may be coupled to the water-resistant VAD lifestyle bag100with a hook133. Thus, for example, the VAD battery pocket142, which may enclose at least one VAD battery144, may be coupled to the water-resistant VAD lifestyle bag100with a hook133. In certain embodiments, a clip141may keep closed each of the VAD device pocket131, the VAD controller pocket140, and the VAD battery pocket142, and ensure that no water of moisture enter or penetrates inside the exemplary pockets.

In some embodiments, the VAD controller pocket140and the at least one VAD battery pocket142is outlined with polypropylene piping with a ⅛ inch polypropylene cord, lined with waterproof lining of 200 Denier Oxford Coated DWR fabric, and contains a styrene insert to maintain the firm shape of the bag. The emergency information window134is constructed of 30,000 super clear plastic and with a zipper chain of 8 inches length.

In certain embodiments, by attaching the VAD device pocket131, the VAD controller pocket140, and the VAD battery pocket142with the lower unit and connecting the removable strap108to the connectors112, the water-resistant VAD lifestyle bag100is assembled. Thus, for example, the water-resistant VAD lifestyle bag100, which stores a VAD device132sensitive to water damage, can be assembled by providing a removable strap108connected to two connectors112along the top of the bag100and having a shoulder pad110, providing a lower unit111having two curved top edges connected to two connectors112and having at least one water bottle pocket120to contain water bottles122of various shapes and a front pocket cover flap118, closing the VAD controller pocket140with the clips141, and closing the VAD battery pocket142with the clips141. In some embodiments, during the exemplary method of making a water-resistant VAD lifestyle bag100for storing a VAD device132sensitive to water damage, the lower unit111may include a zipper124configured along the top of the lower unit111, an emergency information window134made of clear material to view the status of a VAD device132, a plurality of pockets158built into the back of the bag100, at least one credit card pocket160built into the bag100, a VAD controller pocket140having clips141and configured to secure a VAD controller138, and at least one VAD battery pocket142having clips141and fitted to house at least one VAD battery144for powering the VAD device132. Thus, for example, the water-resistant VAD lifestyle bag100provides for multiple and redundant mechanisms to prevent water and moisture from contacting each of the VAD device132, the VAD controller138, and the at least one VAD battery144.

Shown inFIG. 3Ba view of the VAD device pocket131of the water-resistant VAD lifestyle bag100according to an embodiment. The VAD device pocket131is configured to block entry of moisture to the VAD device132. The VAD device pocket131may include a VAD device flap130and hook holes129. The hooks133attached to the lower unit111may pass through the hook holes129to hold the VAD device pocket131secure with the lower unit111. In certain embodiments, the VAD device pocket131may be lined with a piping129that may be 5 inches by 5.5 inches by 0.25 inches. The piping129provides redundancy against water and moisture exposure to the VAD device132and provides firmness to the shape of the VAD device pocket131. In a method of assembling the water-resistant VAD lifestyle bag100, the hooks133are positioned through the hook holes129and the VAD device flap130is sealed closed against the hooks133to provide redundant closure of the VAD device inside of the VAD device pocket131.

Shown inFIG. 3Cis a view of the VAD battery pocket142of the water-resistant VAD lifestyle bag100according to an embodiment. The VAD battery pocket142is configured to block entry of moisture to the at least one VAD battery144. The VAD battery pocket142is 4.25 inches by 3.25 inches by 1.75 inches, and may include a VAD batter pocket flap145that closes shut to seal the at least one VAD battery inside of the VAD battery pocket142.

Shown inFIG. 4Ais a back view of the water-resistant VAD lifestyle bag according to an embodiment. In some embodiments, the at least one water bottle pocket120comprises a bottom hole of ⅝ inch and is 6 inches tall by 7 inches around and may hold a water bottle122. In certain embodiments, the water bottle pocket120may be pouch for holding soda cans, coffee cups, or milk cartons.

Shown inFIG. 4Bis a back view of the water-resistant VAD lifestyle bag100with a plurality of pockets158built into the back of the bag100according to an embodiment. In some embodiments, the plurality of pockets158is configured to secure at least one of pens, phones, and snacks. The plurality of pockets158is constructed of 1,000 Denier Oxford Coated DWR 1stfabric and optionally sewn over with water-resistant lining fabric. The at least one credit card pocket158further comprises a first credit card pocket181that is 5 inches by 2.25 inches, a second credit card pocket182that is 4.75 inches by 2.25 inches, a third credit card pocket183that is 4.25 inches by 2.25 inches, a fourth credit card pocket184that is 4⅜ inches by 2.25 inches, and a fifth credit card pocket185that is 4.25 inches by 2.25 inches. The plurality of pockets158may further comprise at least one of a pen pocket162that is 0.25 inch by 6 inches, a phone pocket162that is 5.25 inches by 7.25 inches, and a snack pocket166that is 7 inches by 4 inches. In certain embodiments, the plurality of pockets158, which may include one or more of the at least one credit card pocket158, the pen pocket162, the phone pocket162, and the snack pocket, can be constructed as a sleeve that is partially open to allow the patient102to easily insert and remove lifestyle accessories.

Shown inFIG. 4Cis a back view of the water-resistant VAD lifestyle bag100with at least one belt loop172sewn onto the back of the bag100according to an embodiment. The at least one belt loop172sewn onto the back of the bag100and may hold onto a belt174. The at least one belt loop172may have seams 2.25 inches apart and made of P 2,200 with 2,000 webbing with UV inhibitors.

Shown inFIG. 4Dis a back view of the water-resistant VAD lifestyle bag100with a sewn extra pocket168onto the back of the bag100according to a dimensioned embodiment. The sewn extra pocket168may be 4.75 inches by 2.25 inches and may be coupled with a zipper124onto the back of the bag100.

In certain embodiments, the water-resistant lifestyle VAD bag100as shown inFIGS. 1, 2A, 2B, 3A, 4A, 4B, 4C, and 4Dmay include internal walls, exterior walls, internal sleeves, an inner layer, and pockets that may be constructed with 1050 Denier Nylon Ballistic cloth coated condura fabric, which provides water-resistant properties. In certain embodiments, the construction of and the components of the water-resistant lifestyle VAD bag100may consist of styrene 0.030, polypropylene black piping, waterproof lining, P2200 webbing with UV inhibitors, and foam ⅛″ polyethylene. In some embodiments, the construction of and the components of the water-resistant lifestyle VAD bag100may be dust-free, non-abrasive, shock resistant, and moisture proof.

One of ordinary skill in the relevant art would have understood that the components of the water-resistant lifestyle VAD bag100described above may be constructed of other materials that may provide the bag or pouch with similar characteristics (i.e., dust free, non-abrasive, shock resistant, moisture proof, water proof, etc.).

Although the technology herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope as defined by the appended claims.