The present disclosure relates generally to medical barriers. Certain embodiments relate to methods of applying a medical barrier to a patient.
Hemodialysis, chemotherapy and other treatments often require patients to tolerate access ports for vascular catheters, which extend through the skin from the outside and into the body. During activities such as bathing or swimming, the access port must be protected from water in order to reduce the risks of infection and contamination. Patients with abrasions or breaks in the outer skin layer also need to protect affected skin.
Contamination can occur through air or water. Some patients, such as renal dialysis patients, are instructed not to take showers or baths. This requires patients to spend considerably more time taking care of their basic hygiene than usual. The requirement to keep access sites free from contaminants is also inconvenient at other times.
Various problems arise when devices are used to protect portions of the skin from contamination and moisture, and various available devices seek to address these problems. Single-use devices, for example, must be easy to use and inexpensive to manufacture, but must also not be prone to leaking when the patient moves as required during normal daily activities such as washing while showering.
Devices should ideally be useful in many circumstances, such as for protecting abrasions and access ports. Devices may also be useful for patients of various shapes and sizes. All devices should seek to maximize effectiveness while introducing minimal constraints and providing maximum comfort to patients during application, removal and during movements of and around the affected area. No available device provides a satisfactory solution to these problems.
The present invention relates to a medical device and, more particularly, to leak-proof and/or leak-resistant medical protective barriers.
In accordance with one aspect of the present invention, a water-resistant medical barrier is provided having a flexible sheet with two sides, an outer side and an inner side. Each side has at least one adhesive portion and, preferably, at least one adhesive perimeter strip.
In some embodiments, the medical barrier is comprised of a rectangular sheet having two sides, an inner side and an outer side. Across one edge of one side of the sheet, the outer side, for example, is a strip of adhesive. Across at least a portion of at least one edge of is a layer of adhesive. In some embodiments, a layer of adhesive is also disposed across at least a portion of at least one of the other three edges of the other side, the inner side, for example, and, more preferably, across all three remaining edges of the other side. In some embodiments, adhesive may also be disposed across the first edge of the inner side, but need not be. Some embodiments have a single adhesive strip with a protective release liner on the superior edge of the outer side of the medical barrier and three adhesive strips with protective release liners on the inferior and two lateral edges of the inner side of the medical barrier.
Some methods of attaching the medical barrier involve a user creating a sealed and protected volume between the skin and the barrier by removing a covering release liner and then coupling the adhesive strip on the superior edge of the outer side of the sheet to the patient and by subsequently folding at least a portion of the inner side of the sheet over itself and removing a release liner covering inferior adhesive strips and attaching the inferior adhesive strip to the patient. In some embodiments, the adhesive on the two lateral edges of the inner side adheres to itself, to the patient, or to a combination of both to form a particular sealed and protected volume. In some embodiments, the protected volume and the surface area of the patient's skin contacting adhesive are adjustable. In some embodiments, adjustments are made by the user's placement of the superior and inferior adhesive strips. The lateral adhesive strips will automatically adjust to a proper contact area based on the placement of the superior and inferior strips and the distance that the patient wants to position the barrier above the skin. The lateral strips will also form lateral seals between the membrane and the patient.
In some embodiments, the waterproof or water-resistant sheet is a film, membrane, or substrate. The film, sheet, or membrane or substrate may be any of myriad of compositions suitable for short-term or long-term contact with the skin. In some embodiments, the flexible and waterproof or water-resistant sheet of material may be comprised of a thin and flexible elastic film. The flexible waterproof sheet of material may alternatively or additionally be comprised of a hydrophilic or hydrophobic material, including, but not limited to, polymers and plastics and water-vapor-breathable films, layers, and materials. The sheet or film may be clear or opaque to any degree without departing from the spirit of the present disclosure. The sheet or film may further be shaped in various ways to carry out the purposes of treatment, including, without limitation, rectangular, square, ovular, circular, or any other suitable regular or irregular shape.
Portions of the flexible and waterproof or water-resistant sheet comprise an adhesive layer or layers disposed upon the flexible waterproof or water-resistant sheet. Such layers may be comprised of, for example, without limitation, pressure-sensitive and/or thermo-sensitive, and/or radiation-sensitive adhesive materials.
In addition to the various compositions possible within the scope of the present disclosure, the adhesive may be disposed using a variety of methods in a variety of fashions and in a variety of configurations. Some embodiments may optimize the skin contact and adhesive properties of the medical protective barrier, such as adhesive strength and configuration or arrangement of the adhesive. In this manner, the protected area is best shielded from water, soap and the like when cleansing. In other embodiments, the adhesive circumscribes the protected area on the patient with the sheet covering the protected area (e.g., an introducer, or access, port). Although the medical protective barrier periphery is believed to be the optimal location for the adhesive, the adhesive may be placed on other portions of the medical protective barrier. Such alternative configurations include, but are not limited to, adhesive applied to portions, but not the entirety, of the periphery, areas extending across the medical protective barrier other than periphery, and areas within the medical protective barrier other than its periphery. Other example configurations include straight line, circular, or zigzag patterns along the periphery of the medical protective barrier. In some embodiments, adhesive is disposed on opposing sides of the film in such a manner as to be suitable for creating a protected volume or a pocket when applied to the patient's skin.
By way of example, some embodiments of the present disclosure comprise a flexible water-proof sheet of material with an adhesive layer disposed on and coupled to the sheet using any of various application techniques well known in the art. In some embodiments the adhesive layer is disposed around a perimeter of the sheet. In some embodiments, the adhesive layer is disposed in concentric parallel lines disposed around the perimeter of the sheet or film or membrane. In some embodiments, the adhesive layer is disposed in a plurality of circular patterns suitably aligned on the surface of the film or membrane. In still other embodiments, the adhesive layer is disposed randomly. In some embodiments, a plurality of adhesive layers is applied in a single or variety of patterns. Some embodiments of the present disclosure comprise a flexible water proof sheet of material with an adhesive layer on both sides and around or along a perimeter of the sheet. In some embodiments, an adhesive is coupled to opposing sides of the film. In some embodiments, a plurality of adhesive layers is applied in a plurality of patterns. One of skill in the art will recognize that the configuration of the adhesive may be varied and yet still fall within the present disclosure.
In some preferred embodiments, at least one layer of adhesive is disposed upon at least a portion of both sides of a membrane or film. In some embodiments, a release or liner layer is removably disposed on the adhesive layer such that the adhesive is protected between the membrane and the release liner until the time desired use.
Some embodiments of the present disclosure comprise a flexible waterproof material sheet of material with an adhesive layer along the perimeter of the sheet and having a release material disposed upon the adhesive layer and comprised of tabs that extend from the perimeter of the sheet. The release material can be comprised of a two-sided strip capable of being removably coupled on at least one portion to an adhesive layer. The release material may be comprised of any suitable material that is capable of being removably coupled to an adhesive layer on at least one portion and which does not adhere significantly or substantially to patient's skin on the other side. The release material is applied in such a fashion as to allow for easy application of medical protective harrier. By covering the adhesive when the device is not in use, the release liner ensures that adhesive retains its maximum and optimal properties until the time of use.
Tabs extending from the edges of the release material assist the user in using the barrier. In some embodiments, these tabs serve to ensure patient comfort is not compromised by incorrect application. In some embodiments, the release liner is configured to contain tab portions extending there from in such a manner as to aid the user in properly applying the barrier. To further facilitate these purposes, tabs may be labeled instructing user on how and in what order to remove the release liners. For example, without limitation, tabs may be configured to overlap one another such that it is difficult or impossible to easily remove one tab without first removing another tab. Tabs may also be configured such that removal of one tab automatically begins removal of another tab. In some embodiments, the tabs are labeled with instructions for the user regarding how to remove the liner or release liner and how to apply the underlying adhesive directly or indirectly to a patient's epidermis. Through such labeling or other configuration, the presently disclose medical barrier guides users to remove the tabs in the proper order to obtain the most desirable application and removal properties of a medical bandage.
The present disclosure also relates to an application method for the disclosed medical barriers. In some embodiments, this application technique comprises the following steps.
In this way, some disclosed methods of applying a medical barrier embodied within the present disclosure allow a user to form a medical protective barrier comprised of a protected and sealed volume, or substantially void volume capable of containing, for example, a medical implement, a PICC introducer, access point, and/or extension. Furthermore, one of ordinary skill in the art will recognize that the present disclosure supports an adjustable and customizable medical barrier. The disclosed means, methods, and devices are ideal for creating a plurality of sizes of protected volumes, covering or substantially void volume using a single size of medical protective barrier. However, it should be understood that some embodiments may exclude some of the above steps or portions of the above steps.
In some embodiments, a portion of a sheet or film upon which adhesive is disposed is accessed and the adhesive is exposed by removing at least a portion of a release liner. The exposed adhesive may then be secured to a patient's body, beneath the protected area, for example, with the remainder of the device extending downward from the protected area. Next, another portion or portions of release material may be removed from adhesive disposed upon the other side of the film. Then, the remainder of the device may be folded back over the previously secured adhesive to orientate the exposed adhesive toward the patient's skin. One of ordinary skill in the art will recognize that this forms a pocket volume within the sheet material between the portions of the sheet upon which adhesive is disposed. Pressing the newly exposed adhesive against the patient's skin will fully enclose and complete the barrier pocket.
Several benefits may be achieved by application methods such as the embodiments described above: One benefit that can be achieved is that the area of adhesion to the user can be significantly reduced. This can reduce stress on the adhesive contact area when placed on curved surfaces of the body and promotes a durable seal. Some embodiments also provide enhanced freedom to move extremities or other body parts normally while showering without compromising the protective seal of the device. Some embodiments allow the user to form a free moving pouch containing the protected devise (such as PICC or IV lines) particularly at areas of an articulating joint (such as the anti-cubital or elbow area) where shear stresses on an adhesive placement near or across a joint can compromise the adhesive seal. A further benefit of a smaller surface area of contact between the adhesive and the patient in some embodiments of the methods and devices described is less patient discomfort when removing the medical protective barrier.
Some additional benefits that may be provided with the presently disclosed medical barriers involve (i) creating a sealed chamber for surrounding PICC/IV lines, wounds, and access sites that optimize the sealing area, barrier volume, length and width, etc, (ii) creating an effective medical protective barrier, and (iii) providing a medical protective barrier having enhanced applicability and usability features such as enhanced ease of application. Some disclosed embodiments also can allow for the use of a release liner comprised of tabs that further enhances applicability and usability. Some disclosed embodiments allow for reduced amount of adhesive required to assure an effective moisture barrier, with can also translate into reduced patient discomfort during removal of a medical barrier. The adhesion area, in some embodiments, comprises a substantially planar contact area between the adhesive and a patient's skin. A further benefit of the disclosed embodiments is the creation of an adjustable-sized protected volume capable of containing a PICC-line or other medical implement. These and other aspects, features and advantages of the present medical barrier will be further understood from a description of certain preferred embodiments illustrated in the attached drawings and described as follows.
Description will now be made of embodiments of a medical barrier having features in accordance with the present invention. It should be understood that the disclosed embodiments present examples in connection with one or more preferred embodiments, and the scope of the present invention is not limited to the embodiments disclosed herein.
Alternatively, the adhesive layers 424 and 426 can be configured such that no slack region is left between opposite edges of the sheet 102, but such that the sheet 102 is stretched or pulled rather taut against the patient 320 as shown in
In some embodiments, tabbed release liners, as discussed with respect to
The embodiment shown in
Although certain preferred embodiments and examples have been discussed herein, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the present disclosure, including the appended claims.
This application is related to and claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/022,285 (filed Jan. 18, 2008), titled “Flexible and Leakproof and/or Leak-Resistant Medical Barrier Systems and Methods of Use,” which is hereby expressly incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2009/031413 | 1/19/2009 | WO | 00 | 7/12/2010 |
Number | Date | Country | |
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61022285 | Jan 2008 | US |