MEDICAL ISOLATION GOWN AND METHOD THEREFOR

Abstract

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.

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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1A is a front view of a portion of a tubular structure or tube shown in a flat configuration that can be utilized for constructing a medical gown according to an embodiment of the present invention;

[0018] FIG. 1B is a rear view of the tubular structure of FIG. 1A;

[0019] FIG. 1C shows front and rear panels of the tubular structure of FIGS. 1A-1B in an open or separated configuration;

[0020] FIG. 2 is a front view of an isolation gown constructed from the tubular structure of FIG. 1A;

[0021] FIG. 3 is a front view of the isolation gown of FIG. 2 shown apart from the tubular structure;

[0022] FIG. 4 is a perspective view of the isolation gown of FIG. 3 with the bottom front and rear edges separated;

[0023] FIG. 5 is a perspective front view of the isolation gown of FIG. 4 donned by a wearer;

[0024] FIG. 6 is a rear view of the isolation gown of FIG. 4 showing wrapped side flaps secured with a tape;

[0025] FIG. 7 is a front view of a medical gown according to another embodiment of the invention showing alternate sealing direction; and

[0026] FIG. 8 is a front view of a medical gown according to another embodiment of the invention showing an alternate sealing configuration.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 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.

[0028] 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.

[0029] 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.

[0030] According to an embodiment of the invention the medical gown of the present invention is derived from a tubular plastic structure or tube. FIGS. 1A-1C show the longitudinal tubular structure of plastic film material of continuous finite length denoted by reference numeral 50 (or “tube 50”) that can be used for constructing the medical gowns of the present invention. In general, the corresponding parts or features in the front and rear of tube 50 and gowns produced from tube 50 are represented with the same numeric designation except that corresponding rear parts or features are generally denoted in an alphanumeric format with the suffix “r”. In addition, symmetrical parts are represented with the same numeric designation except that corresponding symmetrical part or feature on the right side of the illustration are identified by a prime symbol (′) suffix, for example the right edge of tube 50 is denoted by 16′. It will be realized that relative or relational terms such as front and rear, left and right, first and second, top and bottom, upper and lower, and other similar terms are merely used to distinguish various parts, features or attributes shown in the accompanying illustrations to provide those skilled in the art a meaningful understanding of the invention and do not necessarily imply an absolute arrangement, relationship or orientation unless required by the context.

[0031] FIGS. 1A and 1B show front and rear views of tube 50 in a flat configuration, whereas FIG. 1C shows tube 50 with an open leading end revealing the front and back panels of the tubular structure. Tube 50 comprises a front panel or wall section 30 and a rear panel or wall section 30r with seamless side extremities or edges 16 and 16′. Tube 50 includes leading and trailing ends that can be opened. In FIG. 1C, the front and rear leading edges 14 and 14r are shown in a pulled apart configuration revealing a portion of the rear wall section 30r. In the flat configuration of tube 50 (FIGS. 1A-1B), the front and rear wall sections 30 and 30r are mutually superposed with inner surfaces of wall sections 30 and 30r being in close contact with each other. Tube 50 is symmetrical along a vertical center line indicated by reference numeral 22 with side edges 16 and 16′ being equidistant from centerline 22. Tube 50 can be produced by blown film extrusion as is known in the art or by other plastic processing methods. The direction of extruding tube 50 in the blown film process is parallel to edges 16 and 16′ and is shown by arrow 51.

[0032] 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.

[0033] Referring to FIGS. 2 and 3 there is shown a gown 100 in a flat configuration according to an embodiment of the invention wherein like parts bear like reference numerals. While shown in its flat configuration, it will be apparent from FIG. 2 that gown 100 is derived from tube 50 and has a similar longitudinal tubular structure comprising a front and a rear section as discussed above.

[0034] As shown in FIG. 2, gown 100 is shown connected to or associated with tube 50. Gown 100 comprises a front wall section 30 and a rear wall section 30r with closed side extremities or edges 16 and 16′ wherein the front and rear panels are connected or produced in a seamless manner by a blown film process as discussed above with reference to tube 50. In the flat configuration, the front and rear wall sections 30 and 30r are arranged in a mutually superposed and congruent relationship when gown 100 is held closed with inner surfaces of wall sections 30 and 30r being in close contact with each other. Gown 100 is symmetrical along a vertical center line indicated by reference numeral 22 with first edge 16 and second edge 16′ being equidistant from centerline 22.

[0035] 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.

[0036] 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).

[0037] 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 FIGS. 2 and 3, the leading front edge 14 of tube 50 forms the lower front edge of gown 100, while trailing front edge 12 forms the upper front edge of gown 100. Similarly, rear wall section 30r of gown 100 includes a rear upper edge 12r and rear lower edge 14r. The front and rear bottom edges 14 and 14r of gown 100 can be pulled apart for separating wall sections 30 and 30r for donning or wearing gown 100. The rear wall section of gown 100 is not visible in FIGS. 2 and 3 but is partially visible in FIG. 4.

[0038] 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 FIG. 2, the front top edge 12 of gown 100 separates gown 100 from the next gown 100n in the tubular structure or tube 50. Accordingly, a series of gowns can be derived from tube 50 in succession. FIG. 3 shows gown 100 in a flat configuration apart or extracted from tube 50.

[0039] 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).

[0040] 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.

[0041] 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 FIGS. 2 and 3, gown 100 also features sealed regions 26 and 26′ that are proximate and parallel to sealed regions 24 and 24′ respectively. Sealed regions 26 and 26′ also extend inwardly from edges 16 and 16′ respectively. Sealed regions 26 and 26′ are also referred to as auxiliary sealed regions. 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 FIG. 4). The perforated section 32 is configured to be of shorter length than the sealed regions 24 and 26 so that the perforated section 32 does not extend to the sleeve armpit upon separating the sleeve 44 from the rest of the gown material.

[0042] 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 FIG. 4). The perforated section 32′ is configured to be of shorter length than the sealed regions 24′ and 26′ so that the perforated section 32′ does not extend to the sleeve armpit upon severing of the sleeve 44′ from the rest of the gown material. Perforated sections 32 and 32′ are also referred to as underarm perforated sections.

[0043] 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 FIGS. 2 and 3, symmetric pairs of sealed regions—20 and 20′, 24 and 24′, 26 and 26′ are shown in a single-lip-seal format for illustrative purposes, however it will be realized by those skilled in the art that any one or more of the sealed region pairs can utilize a variety of design configurations such as—thin lip, thick lip, single lip, dual lip, or combinations thereof.

[0044] 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.

[0045] FIG. 4 shows gown 100 in a ready-to-wear state with front wall section 30 and rear wall section 30r shown in a pulled apart state revealing both the front bottom edge 14 and rear bottom edge 14r. Neck opening 42 created by the unsealed portion between upper sealed regions 20 and 20′ is configured for accommodating the wearer's neck by separating front top edge 12 and rear top edge 12r. First and second sleeves 44 and 44′ respectively are shown in a detached state from the rest of the gown material for facilitating donning and using gown 100. Sleeves 44 and 44′ are separated from the gown material by severing along perforated sections 32 and 32′ (shown in FIGS. 2-3). The proximal end of sealed regions 24 and 26 defines first armpit area 46, whereas the proximal end of sealed regions 24′ and 26′ defines second armpit area 46′. Extra gown material below sealed regions 26 and 26′ forms flap 52 and 52′ that can be wrapped around the wearer's body to complete donning of gown 100 (best shown in FIG. 6). The gaps 40 and 40′ can be utilized by the wearer for penetrating their hands through the closed edges at the respective distal ends of sleeve portions 44 and 44′.

[0046] FIG. 5 illustrates gown 100 after donning by wearer 80 showing a donning option according to an embodiment of the invention. The unsealed portion or gap 42 between sealed regions 20 and 20′ is adapted for accommodating wearer's neck 84. Sleeves 44 and 44′ are configured for accommodating wearers arms including the wrist region of the wearer. The gap or unsealed portion at the distal end of the sleeves 44 and 44′ is shown penetrated by wearer's hands 82 and 82′. The extra gown material in forms of flaps 52 and 52′ is secured in the rear as further explained below.

[0047] FIG. 6 illustrates the rear or back side of gown 100 after donning by the wearer showing a donning option according to an embodiment of the invention. It will be realized that in the rear view of FIG. 6, the numerical references with prime symbol suffixes are shown on the left side of the illustration. As shown, flap 52′ is wrapped around the rear of gown 100 over flap 52, wherein flaps 52 and 52′ are secured to the rear wall section 30r with at least one adhesive tape closure or tape 54. As shown, the adhesive tape 54 is shown placed closed to the center line of the gown 100 on rear wall section 30r and partially covering sealed regions 26′ and 26. In other embodiments, adhesive tape 54 can be placed at other locations for securing flaps 52 and 52′ depending on the range of motion of the wearer or comfort level for attaching the adhesive closure. The gown can be doffed or removed after use by tearing through the front panel or the rear panel.

[0048] 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.

[0049] FIG. 7 shows gown 110 according to another embodiment of the invention derived from tube 50 showing an alternate sealing arrangement to gown 100. In gown 110, the leading front edge 14 of tube 50 forms the upper front edge of gown 110 and trailing front edge 12 forms the lower front edge 12 of gown 110. Accordingly, in FIG. 7 the machine direction is shown with arrow 51 pointing vertically upright towards leading edge 14. In the embodiment shown in FIG. 7 the sleeves 44 and 44′ are located proximate the leading front edge 14 which forms the upper front edge. The construction of gown 110 is otherwise similar to gown 100 except for the sealing arrangement relative to the leading and trailing edges. The next gown in the series from tube 50 is denoted by 110n and the upper sealing regions 20n and 20′n of gown 110n are also visible in FIG. 7.

[0050] FIG. 8 shows gown 120 according to still another embodiment of the invention that is also constructed from tube 50 and has a similar construction to gown 100, except that it features a modified sealing configuration of the sleeves. In the embodiment shown in FIG. 8, gown 120 includes dual lip sealed regions 25 and 25′ having distal ends at side edges 16 and 16′ and proximal ends at armpit areas 46 and 46′ respectively. Similarly, sealed regions 27 and 27′ may also feature a dual lip configuration.

[0051] 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.

[0052] 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.

[0053] 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.