Vented emergency wound dressings

- Medical Devices, Inc.

A wound dressing provides a tenacious occlusive seal against the skin of a wearer, even in the presence of excessive blood or heavy perspiration. The preferred embodiment combines an adhesive backing layer with a hydrogel island providing superior hydrophilic gel adhesion. The product performs under extreme temperatures (i.e., 32-140° F.), and may be used to hold other dressings in place. The preferred embodiments are entirely translucent, and include a large pull-tab for easy removal. Two dressings may be packaged in a pliable re-sealable protective pouch, thereby forming a portable “kit.” Different “vented” embodiments are disclosed. A preferred structure includes a cover layer peripherally bonded to backing and hydrogel layers having a central aperture therethrough. The cover layer has one or more vent holes, and pressure is released through the central aperture and out the vent hole(s).

Skip to: Description  ·  Claims  ·  References Cited  · Patent History  ·  Patent History
Description
REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional Patent Application Ser. No. 61/915,198, filed Dec. 12, 2013, and is also a continuation-in-part of U.S. patent application Ser. No. 12/748,008, filed Mar. 26, 2010, which claims priority from U.S. Provisional Patent Application Ser. No. 61/163,613, filed Mar. 26, 2009, the entire content of all of which is incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates generally to wound dressings and, in particular, to a wound dressing that provides a unique combination of a flexible backing material and hydrogel to provide a safe and effective patch for emergency situations, including battlefield applications.

BACKGROUND OF THE INVENTION

There are instances when an emergency wound dressing may be required not only to stop bleeding, but also to block the transfer of gasses to or from the lungs. Bullet wounds in battlefield situations represent one such need. Until now, however, there are few if any bandages that will remain affixed to a recipient given heat and moisture from weather, sweating, and so forth.

SUMMARY OF THE INVENTION

This invention is a wound dressing that uses a novel combination of materials to provide a tenacious occlusive seal, even in the presence of excessive blood or heavy perspiration. The preferred embodiment combines an adhesive backing layer with a hydrogel island providing superior hydrophilic gel adhesion. The product performs under extreme temperatures (i.e., 32-140° F.), and may be used to hold other dressings in place. The preferred embodiments are entirely translucent, and include a large pull-tab for easy removal. One or two dressings may be packaged in a pliable re-sealable protective pouch.

Different “vented” embodiments are disclosed. A preferred structure includes a cover layer peripherally bonded to backing and hydrogel layers having a central aperture therethrough. The cover layer has one or more vent holes, and pressure is released through the central aperture and out the vent hole(s).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view drawing that illustrates a preferred embodiment of the invention;

FIG. 2 is a drawing that depicts a vented structure;

FIG. 3 is a drawing that depicts a vented structure with an active status indicator;

FIG. 4 is a partially exploded view of a wound dressing assembly according to the invention;

FIG. 5 is a plan view drawing that shows one set of dimensions.

FIG. 6 is an exploded view drawing that illustrates a vented embodiment of the invention seen from a bottom perspective;

FIG. 7 is a not-to-scale cross section depicting the way in which the venting structure operates;

FIG. 8 is a detail drawing with applicable dimensions;

FIG. 9 shows details of a pouch structure;

FIG. 10 depicts an embodiment of the invention utilizing four vent holes; and

FIG. 11 illustrates an optional valve structure.

 DETAILED DESCRIPTION OF THE INVENTION

This invention is a wound dressing that uses a novel combination of materials to provide a tenacious occlusive seal, even in the presence of excessive blood or heavy perspiration. FIG. 1 is a plan view drawing that illustrates a preferred embodiment of the invention, including a backing layer 104 and a pre-formed hydrogel pad 102. The backing layer 104 is preferably a flexible polyethylene “tape” (i.e., 3.0 mil) having a hypoallergenic pressure-sensitive water-resistant adhesive such as an acrylic adhesive 500. The hydrogel pad 102 may be obtained from Katecho, Inc. of Des Moines, Iowa (product code KM-10). The hydrogel material may be obtained from Katecho, Inc. of Des Moines, Iowa (product code KM-10). The backing material may be obtained from 3M Corp. of St. Paul, Minn. Other vendors are possible.

The hydrogel pad 102 preferably has a periphery 106 spaced apart from the periphery of the backing layer 104 in all dimensions to expose the adhesive layer. An adhesive-free tab 108, which may be embossed, is used to release the pad from a release liner 110. The release liner 110 extends beyond all sides of the backing layer 104, as shown in FIGS. 1-5. The release liner may be a 3.0 mil PET layer. In terms of dimensions, the dressing has a preferred width on the order of 3 to 6 inches and a preferred length on the order of 4 to 8 inches. Other forms besides ovals may be used, including circles, squares and rectangles. Materials other than polyethylene may be used for the backing layer 104 so long as the adhesive and combined system is sufficiently tenacious in terms of adherence to the skin.

FIG. 4 is a partially exploded view of a wound dressing assembly according to the invention, and FIG. 5 is a plan view drawing that shows one set of dimensions. Two systems are shown, enabling the dressings to be folded against one another and placed in a pouch 400 which may be re-sealable, thereby forming a dressing/carrier “kit.”

On occasion, the wound dressing may need to vent pressure built up from a chest cavity, for example. To address this, one or more vents such as 204 may be provided as shown in FIG. 2. As pressure builds around a wound in region 202, it will be released through vent 204. As a further alternative, a passive or active status sensor may be used to indicate a user condition or to show that pressure release has occurred. As shown in FIG. 3, such a monitor 302 may be passive, using dyes or other materials which change color in the presence of oxygen or other gasses, for example. The detector may be active, for example, using an electronic pressure sensor, an acoustic sensor (to detect lung sound) or resistive sensor (to detect perspiration or breathing) and a visual indicator such as an LED. The light may have different colors to convey status (i.e., green =OK; yellow =concern; red =emergency).

In all embodiments, beneficial or therapeutic substances may be added to the hydrogel layer. For example, a clotting agent such as calcium carbonate may be added to aid in clotting, and/or an antimicrobial such as chlorhexidine digluconate may be used. Such substances may be in the range of 1-5% or thereabout.

FIG. 6 is an exploded view drawing that illustrates an alternative vented embodiment of the invention seen from a bottom perspective. The article comprises a backing layer shown at 604 and the hydrogel pad is shown at 602. As with other embodiments disclosed herein, the backing layer is preferably a flexible polyethylene “tape” (i.e., 3.0 mil) having a hypoallergenic pressure-sensitive adhesive. The hydrogel material may be obtained from Katecho, Inc. of Des Moines, Iowa (product code KM-10). The backing material may be obtained from 3M Corp. of St. Paul, Minn. as Part No. 1526. Other material and different vendors are possible.

In the embodiment of FIG. 6, the entire bottom surface of the backing layer 604 is coated with an adhesive shown by the hatching, and the hydrogel pad 602, which is preformed into the shape depicted, is adhered to the backing layer using the adhesive layer, the hydrogel itself, or both. Once adhered, the hydrogel forms an island having a periphery spaced apart from the periphery of the backing layer 104 in all dimensions to expose the adhesive layer. An adhesive-free tab 608 may be provided to release the dressing from a release liner 610. The release liner may be a 3.0 mil PET layer.

In terms of dimensions, the dressing of FIGS. 6, 8 has a preferred width on the order of 3 to 6 inches and a preferred length on the order of 4 to 8 inches. Other shapes besides ovals may be used, including circles, squares and rectangles. Materials other than polyethylene may be used for the backing layer 604 so long as the adhesive and combined system is sufficiently tenacious. A set of applicable dimensions are provided in FIG. 8. Two dressings may be folded against one another and placed in a pouch shown in FIG. 9 which may be re-sealable, thereby forming a dressing/carrier “kit”

Returning to FIG. 6, both the hydrogel layer 602 and backing layer 604 include a central aperture 612 which may be round with a preferred diameter in the range of 0.5 to 1.5 inches. Other dimensions and shapes including oval may be used. On the outer side of the backing layer, facing away from the recipient, there is attached a cover 614 having vent holes 616, 618. The cover 614 is peripherally bonded to the outer surface of the backing layer along line 620. The cover 614 may be the same material as the backing material, 3M No. 1526, and may have roughly the same outer dimensions as the hydrogel pad. The cover 614 may be attached to the backing layer with or without an adhesive, using thermal welding, for example. The Any appropriate peripheral adhesive may be used, including UV-cured products.

FIG. 7 is a not-to-scale cross section depicting the way in which the venting structure operates. As can be seen, if pressure builds up from wound 701 on patient 700, the gasses (or liquids) can flow through aperture 612 and out to atmosphere through vent holes 616, 618. When this happens, the entire cover 614 may pull slightly away from the backing material 604, temporarily creating a pocket 703 that is depressurized through the vent holes. After the pressure is relieved or with negative pressure, the cover 614 will typically fall back onto backing layer 604, thereby maintaining a seal around the wound.

FIG. 10 illustrates a preferred embodiment of the invention using four vent holes 1102, 1104, 1106, 1108 and dimensions. As a further embodiment, as opposed to an open central aperture through the hydrogel and backing layers leading to a pocket formed with the cover layer, a one-way bicuspid or tricuspid valve of the type shown in FIG. 11. The apex of the valve would be oriented away from the recipient, which would open when pressurized and close following pressurization to maintain cleanliness.

Claims

1. A wound dressing, comprising:

a backing layer having a periphery, a front surface with an adhesive layer adapted for patient contact and a back surface facing away from the patient;
a preformed hydrogel pad having a periphery, the hydrogel pad being attached to the front surface of the backing layer, the hydrogel pad and backing layer both further including aligned central apertures;
the periphery of the hydrogel pad being less than that of the backing layer such that a ring of the adhesive layer remains exposed around the hydrogel pad;
a cover peripherally bonded directly to the back surface of the backing layer so as to create an expandable pocket between the cover and the back surface of the backing layer;
wherein the cover includes at least one vent hole through the cover passage such that pressure from the wound temporarily expands the pocket, enabling liquids or gasses from the wound to be vented through the apertures, through the pocket, and out the at least one vent hole passage to atmosphere; and
after the pressure is relieved or with negative pressure, the cover falls back onto the backing layer, thereby eliminating the pocket between the cover and the back surface of the backing layer and maintaining a seal around the wound.

2. The wound dressing of claim 1, wherein the backing layer with the hydrogel pad attached thereto are temporarily held against a larger release layer.

3. The wound dressing of claim 1, wherein the backing layer is a polyethylene tape.

4. The wound dressing of claim 1, further including an adhesive-free tab a pull-tab on the backing layer to assist in removing the wound dressing from the release layer.

5. The wound dressing of claim 1, further including a pouch to protect the dressing, thereby providing a portable kit.

6. The wound dressing of claim 1, having a shape that is circular.

7. The wound dressing of claim 1, having a shape that is rectangular.

8. The wound dressing of claim 1, having a width in the range of 3 to 6 inches.

9. The wound dressing of claim 1, having a length in the range of 4 to 8 inches.

10. A wound dressing, comprising:

a backing layer having a periphery, a front surface adapted for patient contact and a back surface facing away from the patient;
a hydrogel pad having a periphery attached to the front surface of the backing layer, the hydrogel pad and backing layer both further including aligned central apertures;
the periphery of the hydrogel pad being less than that of the backing layer;
a cover having an inner surface bonded directly to the back surface of the backing layer, with the periphery of the cover being larger that the aligned central apertures of the hydrogel pad and the backing layers, thereby forming a pocket between the back surface of the backing layer and the inner surface of the cover;
wherein the pocket formed between the back surface of the backing layer and the inner surface of the cover communicates with at least one passage enabling liquids or gasses from the wound to be vented through the apertures and the pocket to atmosphere; and
wherein, after the pressure is relieved or with negative pressure, the cover falls back onto the backing layer, thereby eliminating the pocket between the cover and the back surface of the backing layer and maintaining a seal around the wound.

11. The wound dressing of claim 10, wherein the backing layer with the hydrogel pad attached thereto are temporarily held against a release layer.

12. The wound dressing of claim 11, further including a pull-tab on the backing layer to assist in removing the wound dressing from the release layer.

13. The wound dressing of claim 10, further including a pouch to protect the dressing, thereby providing a portable kit.

14. The wound dressing of claim 10, wherein the wound dressing is circular.

15. The wound dressing of claim 10, wherein the wound dressing is rectangular.

16. The wound dressing of claim 10, having a width in the range of 3 to 6 inches.

17. The wound dressing of claim 10, having a length in the range of 4 to 8 inches.

Referenced Cited
U.S. Patent Documents
3521632 July 1970 Graham
4904247 February 27, 1990 Therriault et al.
4909244 March 20, 1990 Quarfoot et al.
4920158 April 24, 1990 Murray et al.
4948575 August 14, 1990 Cole et al.
5013769 May 7, 1991 Murray et al.
5052381 October 1, 1991 Gilbert et al.
5059424 October 22, 1991 Cartmell et al.
5076265 December 31, 1991 Wokalek
5106362 April 21, 1992 Gilman
5106629 April 21, 1992 Cartmell et al.
5154706 October 13, 1992 Cartmell et al.
5160322 November 3, 1992 Scheremet et al.
5195977 March 23, 1993 Pollitt
5204110 April 20, 1993 Cartmell et al.
5263922 November 23, 1993 Sova et al.
5423736 June 13, 1995 Cartmell et al.
5429589 July 4, 1995 Cartmell et al.
5447492 September 5, 1995 Cartmell et al.
5465735 November 14, 1995 Patel
5476443 December 19, 1995 Cartmell et al.
5478333 December 26, 1995 Asherman, Jr.
5480717 January 2, 1996 Kundel
5489262 February 6, 1996 Cartmell et al.
5501661 March 26, 1996 Cartmell et al.
5556375 September 17, 1996 Ewall
5603946 February 18, 1997 Constantine
5637080 June 10, 1997 Geng
5674346 October 7, 1997 Kundel
5674523 October 7, 1997 Cartmell et al.
5679371 October 21, 1997 Tanihara et al.
5762620 June 9, 1998 Cartmell et al.
5788682 August 4, 1998 Maget
5804213 September 8, 1998 Rolf
5846214 December 8, 1998 Makuuchi et al.
5902600 May 11, 1999 Woller et al.
5973221 October 26, 1999 Collyer et al.
5977428 November 2, 1999 Bozigian et al.
6040493 March 21, 2000 Cooke et al.
6406712 June 18, 2002 Rolf
6861067 March 1, 2005 McGhee et al.
7265256 September 4, 2007 Artenstein
7429687 September 30, 2008 Kauth et al.
7504549 March 17, 2009 Castellani et al.
7615674 November 10, 2009 Asherman
20010031370 October 18, 2001 Kundel
20030204174 October 30, 2003 Cisko
20040013715 January 22, 2004 Wnek et al.
20050214376 September 29, 2005 Faure et al.
20050256437 November 17, 2005 Silcock et al.
20060015053 January 19, 2006 Crisp
20060200063 September 7, 2006 Munro et al.
20060253079 November 9, 2006 McDonough et al.
20060264796 November 23, 2006 Flick et al.
20070082036 April 12, 2007 Dixon
20080009802 January 10, 2008 Lambino et al.
20080033377 February 7, 2008 Kauth et al.
20080064998 March 13, 2008 Gregory et al.
20080091152 April 17, 2008 Asherman
20080234726 September 25, 2008 Biddle et al.
20120078153 March 29, 2012 Russell et al.
Patent History
Patent number: RE48007
Type: Grant
Filed: Sep 27, 2018
Date of Patent: May 26, 2020
Assignee: Medical Devices, Inc. (Ann Arbor, MI)
Inventors: Stephen Shulman (Ann Arbor, MI), Stuart Shulman (Ann Arbor, MI), Jahan Azziz (Ann Arbor, MI)
Primary Examiner: Beverly M Flanagan
Application Number: 16/144,170
Classifications
Current U.S. Class: Perforated (602/47)
International Classification: A61F 13/00 (20060101); A61F 13/02 (20060101); A61F 17/00 (20060101);