MEDICAL ISOLATION GOWN AND METHOD THEREFOR
A medical gown constructed by heat sealing a tubular plastic structure made by a blown film process. The medical gown having a front panel and a rear panel, two sleeves for covering the arms of a wearer, with the distal end of each sleeve including an opening for enabling the wearer to penetrate their hand therethrough. Each sleeve of the medical gown having an upper seal portion and a lower seal portion, a neck opening between the two upper seal portions of the two sleeves, a gap for accommodating the body of the wearer between the two lower sealed portions of the two sleeves. A perforated section below each sleeve is provided for severing each of the sleeves from the gown material for ease of donning and wearing.
This application claims priority from U.S. Provisional Patent Application No. 63/044,791, filed on Jun. 26, 2020, in the United States Patent and Trademark Office. The disclosure of which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTIONThis invention relates to medical isolation gowns and protective garments. More particularly, the present invention relates to medical isolation gowns having improved fluid impermeability and coverage.
BACKGROUND OF THE INVENTIONMedical workers and health care professionals (HCPs) are routinely exposed to potential biohazards, infectious diseases, bodily fluids, droplet emissions, splashes, and other pathogens. These hazards and the probability for exposure and infection has increased significantly with the global pandemic resulting from the spread of COVID-19 virus.
Medical gowns or “isolation gowns” are worn by HCPs including doctors, nurses, physician assistants, and hospital workers while treating patients that may have been exposed to contagious and infectious diseases to prevent cross-contamination to other patients or other HCPs or visitors.
Recently, there has been a multifold increase in the need for adequate isolation gowns and protective garments that can be readily manufactured and conveniently donned and doffed to allow a medical professional to attend to the traffic of patients in need of medical care in a more efficient manner.
Thus, there is an intense need for enhancing usability, manufacturability, and effectiveness of isolation gowns for HCPs and others. These and other needs, as shall hereinafter appear, are met by the gown devices and method of the present invention.
SUMMARY OF THE INVENTIONAn insight that led to the present invention was the recognition that a tubular plastic structure can be converted to a medical gown by strategically heat sealing, or heat sealing and perforating certain portions of the tubular structure, without requiring assembly of multiple parts for creating various parts of the gown.
Accordingly, the present invention provides a medical gown that can be obtained from a tubular plastic structure.
The present invention provides an isolation gown that does not require assembly of multiple parts.
According to an embodiment of the invention, the medical gown is constructed from a tubular structure of plastic material, wherein the tubular structure is manufactured by a blown film process.
The present invention provides a medical gown that can be constructed by heat sealing the tubular structure of the plastic material in a flat configuration.
According to an embodiment of the invention, there is provided a medical gown comprising two sleeves for covering the arms of the wearer, wherein each sleeve includes an upper seal portion and a lower seal portion, and wherein the gown includes a first gap between the two upper seal portions of the respective sleeves, the first gap defining a neck opening, and a second gap between the two lower seal portions of the respective sleeves, the second gap being configured for accommodating the body of the wearer.
According to an embodiment of the invention, the sleeves of the gown have a uniform gap between the upper seal portion and a lower seal portion. In embodiments the sleeves are sealed perpendicular to the vertical centerline of the gown that runs from the neck opening to the bottom of the gown.
According to another embodiment of the invention, there is provided a medical gown comprising two sleeves for covering the arms of the wearer, a perforated section below each of the sleeves to sever each of the sleeves from a flap region below each sleeve, wherein the flap regions below the two sleeves are configured for being overlapped and secured with an adhesive tape or label at the back or the front of the wearer to complete the donning of the medical gown.
According to still another embodiment of the invention, the perforated section below each sleeve does not an extend to the armpit region of the wearer for preventing an access path therethrough.
The features and advantages described herein are not all-inclusive and many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and the claims. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.
The present invention is described herein with reference to only a few of the exemplary embodiments, nonetheless, it should be understood that the description herein is illustrative of the invention and is not to be considered as limiting the invention to the specific embodiments or features that are shown or described herein. The invention is capable of various modifications and variations that can be conceived by one of skill in the art, and all such modifications and variations are deemed to be included within the scope of the invention.
In embodiments, the medical gown of the present invention is made from suitable materials offering acceptable fluid barrier properties for the intended purpose at a health care facility or establishment. According to a specific embodiment of the invention the medical gown of the present invention can be utilized as an isolation gown by HCPs while treating patients. A variety of fluid impermeable materials of suitable thickness can be utilized for fabricating the medical gown of the present invention. Accordingly, plastics, bioplastics, non-woven webs, and/or combinations thereof can be utilized to practice various embodiments of the invention. Particularly, polyolefin materials including polyethylene, linear low-density polyethylene, low density polyethylene, high density polyethylene, polypropylene, and blends thereof can be utilized for constructing the medical gowns of the present invention. In addition, colorants, pigments, fillers and processing aids can also be incorporated in the plastic material for manufacturing gowns according to the present invention. According to an embodiment, the medical gown of the present invention is made from a suitable grade of polyethylene that is compliant with appropriate regulations for use in medical devices by Food and Drug Administration (FDA) and/or other regulatory agencies.
According to another embodiment of the invention the medical gown of the present invention has non-isotropic tear properties to facilitate tearing of the gown for doffing after use.
According to an embodiment of the invention the medical gown of the present invention is derived from a tubular plastic structure or tube.
In embodiments, tube 50 is extruded from suitable grade of polyethylene that is compliant with appropriate regulations for use in medical devices by Food and Drug Administration (FDA) and/or other regulatory agencies. According to an embodiment of the invention tube 50 is extruded from a blend comprising low density polyethylene resin and high-density polyethylene resin. In other embodiments of the invention, the plastic material can be a blend of low molecular weight and high molecular weight polymeric material. In still other embodiments of the invention, the plastic material can be a compostable resin. In still other embodiments cyclic polyolefins and ethylene propylene rubber can be utilized for constructing the tubular structure for producing gowns of the present invention. The front and rear wall sections of tube 50 may feature smooth surfaces. Alternately, the wall sections of tube 50 or at least portions thereof may feature textured, patterned, or embossed surfaces. Tube 50 may also be configured to include both smooth and embossed surfaces.
Referring to
As shown in
The front and rear wall sections 30 and 30r of gown 100 are bonded or joined together by heat sealing, ultrasonic bonding, induction sealing, or other bonding methods known in the art at various locations or sealed regions as described below for providing a wearable structure. In general, it will be recognized that any of the individual wall sections 30 or 30r as well as any sealed regions provided in gown 100 are configured to have adequate and sufficient mechanical, physical and barrier properties under general conditions of use typically required for isolation gowns and as may be required by applicable regulatory standards for the intended purpose. In embodiments, gown 100 is configured as a non-surgical isolation gown. In other embodiments, gown 100 is configured as a surgical isolation gown. In still other embodiments of the invention, gown 100 is configured for splash protection from liquids at home, work, and in industrial settings.
In embodiments, gown 100 is configured to meet or exceed the requirements promulgated by American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI) under ANSI/AAMI PB70:2012 standard (the “PB70 Standard”), which addresses liquid barrier performance and classifies a gown's ability to serve as a barrier to penetration by liquids or liquid-borne pathogens. The PB70 Standard has also been formally recognized by the US Food and Drug Administration (US FDA). The PB70 Standard defines critical protective zones for surgical and non-surgical gowns and establishes four levels of barrier protection, namely, Level 1 (Minimal risk; basic care), Level 2 (Low risk; veinal blood draw, ICU, pathology lab), Level 3 (Moderate risk; arterial blood draw, emergency room, trauma), Level 4 (High risk; pathogen resistance, non-airborne infectious diseases, long duration fluid exposure).
The front panel or wall section 30 of gown 100 includes a leading front edge 14 and a trailing front edge 12. In the embodiment shown in
Gown 100 can be separated from the tube 50 at front and rear top edges 12 and 12r by shearing, perforating, or cutting through the tubular front and rear wall sections 30 and 30r. As shown in
Gown 100 includes a left sleeve 44 and a right sleeve 44′, wherein the sleeves 44 and 44′ are symmetrical about center line 22 and configured for accommodating and covering the wearer's arms including the wrist region of the wearer. Left sleeve 44 is defined by an upper sealed region 20 and a lower sealed region 24. Similarly, right sleeve 44′ is defined by an upper sealed region 20′ and a lower sealed region 24′. Sleeves 44 and 44′ are substantially straight with uniform sleeve gap between upper and lower sealed regions indicated by arrow 36. It will be thus realized that in the straight sealing configuration of sleeves 44 and 44′, the width of the tubular structure or distance between edges 16 and 16′ is configured to accommodate the arm-span of a human wearer and gown 100 can be made in a variety of sizes according to the arm-span(s), trunk size(s) and height(s) of the wearer(s).
Gown 100 includes a neck opening 42 that is centrally located between the upper sealed regions 20 and 20′ of sleeves 44 and 44′ respectively. The upper sealed region 20 does not extend all the way to edge 16 and a relatively narrow gap 40 is provided in sleeve 44 between sealed region 20 and edge 16 for enabling a wearer to insert their hand therethrough for donning the gown 100. Similarly, gap 40′ is provided in sleeve 44′ between sealed region 20′ and edge 16′ for enabling the wearer to insert their other hand therethrough. In an alternate donning procedure, gaps 40 and 40′ can be utilized as thumb loops and the wearer pierces through the closed edges at the distal ends of sleeves 44 and 44′ for creating openings for the remaining fingers.
The lower sealed regions 24 and 24′ of sleeves 44 and 44′ extend inwardly from edges 16 and 16′ respectively and terminate at respective armpit areas 46 and 46′. The sealed regions 24 and 24′ are of equal width and symmetrically located about centerline 22 and are spaced apart from each other by gap 38 that is configured for accommodating the wearer's torso area. As shown in
Sealed regions 24′ and 26′ bear a symmetrical relationship to regions 24 and 26, respectively. In between sealed regions 24′ and 26′ there is provided a perforated section 32′ that allows severing of the gown material along the frangible perforations for separating the sleeve 44′ from the excess material below the sealed region 26′. The excess material below sealed region 26′ is denoted by flap 52′ (explained further in reference to
It will be apparent from the above description that sealed regions 20, 24 and 26 are co-symmetric with correspondingly respective sealed regions 20′, 24′ and 26′ about centerline 22. In the exemplary embodiment shown in
The inner surfaces of gown 100 can be accessed by pulling apart front and rear bottom edges 14 and 14r and separating wall sections 30 and 30r for donning and wearing gown 100.
In alternate embodiments of the invention, flaps 52 and 52′ can be manipulated and secured in a variety of configurations including—securing the flaps in rear by employing a plurality of tape closures at multiple locations; securing the flaps in the front with one or more tape closures to provide extra layers of splash protection; and securing one of the flaps in the front and one of the flaps in the back to provide extra protection at both the front and the back of the wearer. Flaps 52 and 52′ can also be left loose on the sides.
It will be appreciated by those skilled in the art that gowns 100, 110 and 120 shown in various Figures can be obtained in a single heat-sealing operation thus significantly simplifying the process of creating a useable medical or isolation gown with all its components in one operation. It will be however realized that the sealed regions can be sealed in multiple steps or sequentially depending on the sealing equipment configuration.
The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description and not for limiting the scope of the invention. Each and every page of this submission, and all content herein, however characterized, identified, or numbered, is considered a substantive part of this application for all purposes, irrespective of form or placement within the application. This specification is not intended to be exhaustive. Although the present application is shown in a limited number of forms, the scope of the invention is not limited to just these forms but is amenable to various changes and modifications without departing from the spirit thereof.
It will also be apparent to those skilled in the art from the foregoing description that many modifications and variations to the embodiments shown herein are possible in light of this disclosure. Accordingly, the claimed subject matter includes any combination of the above-described elements in all possible variations thereof, unless otherwise indicated herein or otherwise clearly contradicted by context. In particular, the limitations presented in examples of dependent claims below can be combined with their corresponding independent claim examples in any number and in any order without departing from the scope of this disclosure, unless the dependent claims are logically incompatible with each other.
Claims
1. A medical gown for protecting a wearer, said gown comprising:
- a front panel and a rear panel, said front and rear panels forming a tubular structure, said tubular structure including an open bottom end for donning said medical gown;
- a first sleeve defined by a first upper sealed region and a first lower sealed region;
- a second sleeve defined by a second upper sealed region and second lower sealed region, each of the first and second sleeves being configured to cover an arm of the wearer to an area proximate a wrist of the wearer;
- a gap provided at a distal end of each of said first and second sleeves, said gap being configured for penetration of a hand of the wearer therethrough; and
- a neck opening defined by a first unsealed region between the first upper sealed region and the second upper sealed region.
2. The medical gown according to claim 1, wherein the medical gown is comprised of a fluid impermeable material.
3. The medical gown according to claim 1, wherein the medical gown is constructed from a plastic material.
4. The medical gown according to claim 1, wherein the medical gown is constructed from a bioplastic material.
5. The medical gown according to claim 1, wherein the medical gown is constructed from a polyolefin material comprising at least one of—linear low-density polyethylene, low density polyethylene, high density polyethylene, and polypropylene.
6. The medical gown according to claim 1, wherein the medical gown is constructed from a material comprising a blend of—a grade of polyethylene, a filler, an anti-block additive, and a colorant.
7. The medical gown according to claim 1, wherein the tubular structure is formed of a blown film having a continuous finite length.
8. The medical gown according to claim 1, wherein the medical gown is configured for tearing and doffing after use.
9. The medical gown according to claim 1, wherein the medical gown is generally symmetrical along a vertical center line.
10. The medical gown according to claim 1, wherein the medical gown meets at least the minimum level regulatory requirements under the ANSI/AAMI PB70 standard.
11. The medical gown according to claim 1, wherein said gown can be constructed in a plurality of sizes for accommodating a plurality of wearers.
12. The medical gown according to claim 1, wherein at least one of the front and rear panels of the medical gown features a smooth surface.
13. The medical gown according to claim 1, wherein at least one of the front and rear panels of the medical gown features an embossed surface.
14. The medical gown according to claim 1, wherein at least one of the front and rear panels of the medical gown features a textured surface.
15. The medical gown according to claim 1, wherein said neck opening defined by said first unsealed region ranges from about 8.5 inches to about 12.5 inches.
16. The medical gown according to claim 1, wherein said neck opening defined by said first unsealed region is greater than 9 inches.
17. The medical gown according to claim 1, wherein said gap is greater than 1 inch.
18. The medical gown according to claim 1, wherein said gap is about 2 inches.
19. The medical gown according to claim 1, wherein the length of the first upper sealed region ranges from 24 to 36 inches.
20. The medical gown according to claim 1, wherein the length of the first lower sealed region ranges from 16 to 25 inches.
21. The medical gown according to claim 1, wherein an unsealed length between the first lower sealed region of the first sleeve and the second lower sealed region of the second sleeve ranges from about 28 to 35 inches for accommodating a body portion of the wearer.
22. The medical gown according to claim 1, wherein the height of the gown from the neck opening to the open bottom end ranges from 42 to 60 inches.
23. The medical gown according to claim 1, wherein the tubular structure includes a first side edge and a second side edge.
24. The medical gown according to claim 23, wherein the width of the tubular structure defined by the distance between the first side edge and the second side edge in a flat configuration ranges from 65 inches to 80 inches.
25. The medical gown according to claim 1, wherein the first sleeve is substantially straight with a uniform gap between the first upper sealed region and the first lower sealed region.
26. The medical gown according to claim 1, wherein the second sleeve is substantially straight with a uniform gap between the second upper sealed region and the second lower sealed region.
27. The medical gown according to claim 25, wherein the uniform gap is at least 9 inches.
28. The medical gown according to claim 26, wherein the uniform gap is at least 9 inches.
29. The medical gown according to claim 25, wherein the uniform gap is less than 12.5 inches.
30. The medical gown according to claim 26, wherein the uniform gap is less than 12.5 inches.
31. The medical gown according to claim 1, comprising a further sealed region proximate and parallel to the first lower sealed region.
32. The medical gown according to claim 1, further comprising:
- a first underarm perforated section located proximately below the first lower sealed region of the first sleeve, said first underarm perforated section being configured for severing said first sleeve from a first gown portion below said first sleeve, and
- a second underarm perforated section located proximately below the second lower sealed region of the second sleeve, said second underarm perforated section being configured for severing said second sleeve from a second gown portion below said second sleeve.
33. The medical gown according to claim 32, wherein the first gown portion below said first sleeve is denoted by a first flap to be wrapped around a body of the wearer of the medical gown; and, wherein the second gown portion below said second sleeve is denoted by a second flap to be wrapped around the body of the wearer of the medical gown.
34. The medical gown according to claim 33, wherein the first and second gown portions below said first and second sleeves are configured for securing with an adhesive tape after donning by the wearer.
35. The medical gown according to claim 33, further comprising a first auxiliary sealed region proximately below said first underarm perforated section, and a second auxiliary sealed region proximately below said second underarm perforated section.
36. The medical gown according to claim 1, further comprising a first auxiliary sealed region below said first lower sealed region and a perforated section in-between the first lower sealed region and the first auxiliary sealed region, wherein the perforated section is shorter than the first lower sealed region and the first auxiliary sealed region.
37. The medical gown according to claim 36, further comprising a second auxiliary sealed region below said second lower sealed region and a perforated section in-between the second lower sealed region and the second auxiliary sealed region, wherein the perforated section is shorter than the second lower sealed region and the second auxiliary sealed region.
38. The medical gown according to claim 37, wherein each of the first and second auxiliary sealed regions feature a dual lip seal configuration.
39. The medical gown according to claim 1, wherein each of the first and second lower sealed regions feature a dual lip seal configuration.
Type: Application
Filed: Jun 24, 2021
Publication Date: Dec 30, 2021
Inventors: Harry Wilfong (Hartsville, SC), Peter Chen (Yorktown, VA), Gary Littlejohn (Zillah, WA), Kevin McCormick (Yakima, WA), Jim Kelley (Okeana, OH)
Application Number: 17/357,472