WO2021263096A1

WO2021263096A1 - Medical isolation gown with improved donning and doffing features and method therefor

Info

Publication number: WO2021263096A1
Application number: PCT/US2021/039076
Authority: WO
Inventors: Harry B. WILFONG; Jim Kelley
Original assignee: Novolex Holdings LLC
Priority date: 2020-06-26
Filing date: 2021-06-25
Publication date: 2021-12-30
Also published as: US20210401091A1

Abstract

A medical gown constructed by heat sealing a tube made by a blown film process. The medical gown having a front panel and a rear panel, a vertical perforation running along the rear panel centerline, two sleeves for covering the arms of a wearer, a sleeve perforation for enabling the wearer to penetrate a portion of their hand therethrough. Each sleeve of the medical gown having an upper seal portion and a lower seal portion, a neck opening between the upper seal portions of the two sleeves, a gap between the lower sealed portions of the two sleeves for accommodating the body of the wearer. An underarm perforation below each sleeve facilitates severing of each of the sleeves from the gown material. Supplemental perforations on either side of the gown are also provided for yielding a pair of straps that can be tied at the rear of the gown.

Description

MEDICAL ISOLATION GOWN WITH IMPROVED DONNING AND DOFFING

FEATURES AND METHOD THEREFOR

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority from U.S. Provisional Patent Application No. 63/044,810, filed on June 26, 2020 and U.S. Utility Patent Application No. 17/357,432, filed on June 24, 2021, in the United States Patent and Trademark

Office. The disclosure of which are incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] This invention relates to medical isolation gowns and protective garments. More particularly, the present invention relates to medical isolation gowns having improved donning and doffing features.

BACKGROUND OF THE INVENTION

[0003] Medical 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.

[0004] 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.

[0005] 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.

[0006] 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 INVENTION

[0007] The present invention features a tubular plastic structure that 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, and that further provides improved donning and doffing characteristics.

[0008] Accordingly, the present invention provides a medical gown that can be obtained from a tubular plastic structure that is easy to remove after use.

[0009] The present invention provides an isolation gown that does not require assembly of multiple parts. [0010] 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 from polyethylene resin or blends thereof.

[0011] 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.

[0012] 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.

[0013] According to an embodiment of the invention, the rear panel of the gown includes a frangible perforation that runs proximate the center line of the rear panel from the back of the neck region of the wearer to the entire vertical length of the gown for facilitating tearing so that the gown can be conveniently removed after use.

[0014] According to another embodiment of the invention, there is provided a gap at the upper distal end of each sleeve to serve as a thumb loop and a finger perforation section proximate the gap of each sleeve configured for facilitating penetration of wearer’s hand through the finger perforation section with ease. The finger perforation section is also referred to as sleeve perforation in some of the embodiments. The thumb loop is intended to retain the sleeves in an extended configuration and prevent the sleeves from riding up the arm, thereby assuring coverage and protection of the entire arm including the wrist region of the wearer during use.

[0015] According to another embodiment of the invention, there is provided a medical gown comprising two sleeves for covering the arms of the wearer, a sleeve separating perforation below each of the sleeves to sever each of the sleeves from the gown material or 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.

[0016] According to still another embodiment of the invention, the sleeve separating perforation below each sleeve does not an extend to the armpit region of the wearer for preventing an access path therethrough.

[0017] According to yet another embodiment of the invention, there is provided a strap perforation below each of the sleeve separating perforations, wherein each strap perforation yields a tie-strap once severed from the gown material, and the two tie-straps thus created under the two sleeves can then be tied together behind the wearer’s back for securing the extra gown material.

[0018] 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.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1A is a front view of tube 50 shown in a flat configuration that can be utilized for constructing a medical gown according to an embodiment of the present invention;

[0020] FIG. IB is a rear view of the tube shown in FIG. 1A;

[0021] FIG. 1C is a view of the tube 50 showing the front and rear panels thereof with the leading end of tube 50 shown in an open or separated configuration;

[0022] FIG. 2A is a front view of tube 70 shown in a flat configuration that can be utilized for constructing a medical gown according to an embodiment of the present invention;

[0023] FIG. 2B is a rear view of tube 70 showing a continuous vertical perforated section that can be utilized for doffing according to an embodiment of the present invention;

[0024] FIG. 2C is a view tube 70 showing the front and rear panels thereof with the leading end of tube 70 shown in an open or separated configuration;

[0025] FIG. 3A is a front view of an isolation gown constructed from the tubular structure shown in FIGS. 2A-2C according to an embodiment of the invention; [0026] FIG. 3B is a rear view of the isolation gown of FIG. 3A shown apart from the tubular structure;

[0027] FIG. 4 is a perspective view of the isolation gown of FIGS. 3A- 3B with the bottom front and rear edges separated;

[0028] FIG. 5 is a perspective front view of the isolation gown of FIG. 4 donned by a wearer;

[0029] FIG. 6 is a rear view of the isolation gown of FIG. 4 showing wrapped side flaps secured with a tape;

[0030] FIG. 7 is a rear view of an isolation gown featuring a perforation at the distal end of each sleeve for ease of donning according to another embodiment of the invention;

[0031] FIG. 8 is a partial front view of the isolation gown of FIG. 7 donned by a wearer;

[0032] FIG. 9 is a rear view of an isolation gown featuring more secure armpit areas according to another embodiment of the invention;

[0033] FIG. 10 is a rear view of an isolation gown according to another embodiment of the invention having opposite machine direction orientation to the gown shown in FIG. 9;

[0034] FIG. 11 is a rear view of an isolation gown according to another embodiment of the invention featuring a gap at the distal end of lower sealed region of each sleeve;

[0035] FIG. 12 is a rear view of an isolation gown according another embodiment of the invention featuring tapered sleeves; [0036] FIG. 13 is a rear view of an isolation gown featuring a strap perforation below each of the sleeves for providing straps for securing the gown in the back;

[0037] FIG. 14 is a rear view of the isolation gown of FIG. 13 shown with straps tied in the back;

[0038] FIG. 15 is a rear view of an isolation gown featuring tapered sleeves wherein the armpit region includes an arcuate sealed region and inclined strap perforation and inclined finger perforated section;

[0039] FIG. 16 is a front view of an isolation gown featuring tapered sleeves and a gap at the distal end of lower sealed region of each sleeve; and

[0040] FIG. 17 is a front view of an isolation gown featuring tapered sleeves wherein the lower sealed region of each sleeve converges with another sealed region at a proximal end of each sleeve.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] 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. [0042] 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 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 the medical 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.

[0043] In embodiments, medical gowns of the present invention are 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).

[0044] 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.

[0045] 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 or “tube 50” that can be used for constructing the medical gowns according to an embodiment of the present invention. FIGS. 2A- 2C show the longitudinal tubular structure of plastic film material of continuous finite length or “tube 70” that can be used for constructing the medical gowns according to an embodiment of the present invention.

[0046] In general, the corresponding parts or features in the front and rear of tube 50 and 70 and gowns produced therefrom 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.

[0047] FIGS. 1A and IB show front and rear views of tube 50 in a flat configuration respectively, whereas FIG. 1C shows tube 50 with an open 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 (visible in FIG. IB) with seamless side extremities or edges 16 and 16’ . The front and rear panels of tube 50 are substantially identical. 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 left edge 16 and right edge 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.

[0048] FIGS. 2A and 2B show front and rear views of tube 70 in a flat configuration, whereas FIG. 2C shows tube 70 with an open leading end revealing the front and back panels of the tubular structure. Tube 70 comprises a front panel or wall section 60 and a rear panel or wall section 60r with seamless side extremities or edges 66 and 66’ . Tube 70 is symmetrical along a vertical center line indicated by reference numeral 22 with side edges 66 and 66’ being equidistant from centerline 22. In contrast to tube 50, the front and rear panels of tube 70 have a different structure, specifically the rear panel 60r of tube 70 includes a perforated section 72 proximate center line 22 line that runs longitudinally parallel to edges 66 and 66’. It will be realized that perforated section 72 can be located at the center line 22 or placed proximate thereto such that perforated section 72 is either close to edge 66’ or edge 66. Printed indicia denoted by reference numeral 74 can also be provided next to the perforated section 72 for instructing the wearer on handling the gowns constructed from tube 70 as described hereinafter in conjunction with the various gown embodiments constructed from tube 70.

[0049] Tube 70 includes leading and trailing ends that can be opened. In FIG. 2C, the front and rear leading edges 64 and 64r are shown in a pulled apart configuration revealing a portion of the rear wall section 60r showing the perforated section 72. In the flat configuration of tube 70 (FIGS. 2A-2B), the front and rear wall sections 60 and 60r are mutually superposed with inner surfaces of wall sections 60 and 60r being in close contact with each other. Tube 70 can be produced by blown film extrusion process as is known in the art or by other plastic processing methods. The direction of extruding tube 70 in the blown film process is parallel to edges 66 and 66’ and is shown by arrow 71.

[0050] In embodiments, tube 70 (or 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 70 (or 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 for tube 50 or tube 70 can be a blend of low molecular weight and high molecular weight polymeric material. According to an embodiment of the invention tube 70 (or 50) is made from a blend of linear low-density polyethylene (LLDPE), low density polyethylene (LDPE), calcium carbonate and colorant. According to another embodiment of the invention tube 70 (or 50) is made from a blend of LLDPE, calcium carbonate filler and colorant. 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 either tube 50 or tube 70 may feature smooth, textured, or embossed surfaces. For instances, certain wall sections or portions of the gowns according to the present invention may feature textured, patterned, or embossed surfaces. According to an embodiment of the invention, tube 70 (or tube 50) is configured to include both smooth and embossed surfaces.

[0051] Referring to FIGS. 3 A and 3B there are shown front and rear views of gown 200 in a flat configuration according to an embodiment of the invention wherein like parts bear like reference numerals. It will be apparent from the Figures that gown 200 is derived from tube 70 and has a similar longitudinal tubular structure comprising a front and a rear section as discussed above. It will be realized that in the rear view of FIG. 3B, the numerical references with prime symbol suffixes are shown on the left side of the illustration.

[0052] As shown in FIG. 3A, gown 200 is shown connected to or associated with tube 70. Gown 200 comprises a front wall section 60 and a rear wall section 60r with closed side extremities or edges 66 and 66’ 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 70. In the flat configuration, the front and rear wall sections 60 and 60r are arranged in a mutually superposed and congruent relationship when gown 200 is held closed with inner surfaces of wall sections 60 and 60r being in close contact with each other. Gown 200 is symmetrical along a vertical center line indicated by reference numeral 22 with left edge 66 and right edge 66’ being equidistant from centerline 22.

[0053] The front and rear wall sections 60 and 60r of gown 200 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 60 or 60r as well as any sealed regions provided in gown 200 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 200 is configured as a non-surgical isolation gown. In other embodiments, gown 200 is configured as a surgical isolation gown. In still other embodiments of the invention, gown 200 is configured for splash protection from liquids at home, work, and in industrial settings.

[0054] The front panel or wall section 60 of gown 200 includes a leading front edge 64 and a trailing front edge 62. As shown in FIG. 3A the leading front edge 64 of tube 70 forms the lower front edge of gown 200, while trailing front edge 62 forms the upper front edge of gown 200. In the rear panel view of FIG. 3B, rear wall section 60r of gown 200 includes a rear upper edge 62r and rear lower edge 64r. The front and rear bottom edges 64 and 64r of gown 200 can be pulled apart for separating wall sections 60 and 60r for donning or wearing gown 200.

[0055] Gown 200 can be separated from the tube 70 at front and rear top edges 62 and 62r by shearing, perforating or cutting through the tubular front and rear wall sections 60 and 60r. As shown in FIG. 3A, the front top edge 62 of gown 200 separates gown 200 from the next gown 200n in the tubular structure 70. Accordingly, a series of gowns can be derived from tube 70 in succession. FIG. 3B shows a rear view of gown 200 in a flat configuration apart or extracted from tube 70.

[0056] As shown in front view of FIG. 3A, gown 200 includes a left sleeve 250 and a right sleeve 250’, wherein sleeves 250 and 250’ 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 250 is defined by an upper sealed region 220 and a lower sealed region 230. Similarly, right sleeve 250’ is defined by an upper sealed region 220’ and a lower sealed region 230’. Sleeves 250 and 250’ 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 250 and 250’, the width of the tubular structure or distance between edges 66 and 66’ is configured to accommodate the arm-span of a human wearer and gown 200 can be made in a variety of sizes according to the arm-span(s), trunk size(s) and height(s) of the wearer(s).

[0057] It will be realized, however, that gowns can be constructed with tapered sleeves as explained in other exemplary embodiments described herein.

[0058] Gown 200 includes a neck opening 242 that is centrally located between the upper sealed regions 220 and 220’ of sleeves 250 and 250’ respectively. The lower sealed regions 230 and 230’ of sleeves 250 and 250’ respectively are of equal width and symmetrically located about centerline 22 and are spaced apart from each other by gap 238 that is configured for accommodating the wearer’s torso or chest area. The upper sealed region 220 does not extend all the way to edge 66 and a relatively narrow gap 240 is provided in sleeve 250 between sealed region 220 and edge 66 for enabling a wearer to insert their hand therethrough for donning the gown 200. Similarly, gap 240’ is provided in sleeve 250’ between sealed region 220’ and edge 66’ for enabling the wearer to insert their other hand therethrough. In an alternate donning procedure, gaps 240 and 240’ can be utilized as thumb loops and the wearer pierces through the closed edges of the gown material at the distal ends of sleeves 250 and 250’ for creating openings for the remaining fingers.

[0059] The lower sealed regions 230 and 230’ of sleeves 250 and 250’ extend inwardly from edges 66 and 66’ respectively and terminate at respective armpit areas 246 and 246’. The sealed regions 230 and 230’ are of equal width and symmetrically located about centerline 22 and are spaced apart from each other by gap 238 that is configured for accommodating the wearer’s torso area. As shown in FIGS. 3A-3B, gown 200 also features sealed regions 260 and 260’ that are proximate and parallel to sealed regions 230 and 230’ respectively. Sealed regions 260 and 260’ also extend inwardly from edges 66 and 66’ respectively. In between sealed regions 230 and 260 there is provided a perforated section 232 that allows severing of the gown material along the frangible perforations for separating the sleeve 250 from the excess material below the sealed region 260. The excess material below sealed region 260 is denoted by flap 270 (explained further in reference to FIG. 4). The perforated section 232 is configured to be of shorter length than the sealed regions 230 and 260 so that the perforated section 232 does not extend to the sleeve armpit upon separating the sleeve 44 from the rest of the gown material.

[0060] As shown in the rear view of FIG. 3B and discussed above with respect to construction of tube 70 there is provided a rear perforated section 72 proximate center line 22 line that runs longitudinally parallel to edges 66 and 66’. It will be realized that rear perforated section 72 can be located such that perforated section 72 is closer to edge 66’, closer to edge 66 or equidistant from edges 66’ and 66. Printed indicia denoted by reference numeral 74 can also be provided next to the rear perforated section 72 for instructing the wearer on handling the gowns constructed from tube 70.

[0061] Sealed regions 230’ and 260’ bear a symmetrical relationship to regions 230 and 260 respectively. In between sealed regions 230’ and 260’ there is provided a perforated section 232’ that allows severing of the gown material along the frangible perforations for separating the sleeve 250’ from the excess material below the sealed region 260’ . The excess material below sealed region 26’ is denoted by flap 270’ (explained further in reference to FIG. 4). The perforated section 232’ is configured to be of shorter length than the sealed regions 230’ and 260’ so that the perforated section 232’ does not extend to the sleeve armpit upon severing of the sleeve 250’ from the rest of the gown material. It will be realized that perforated sections 232’ and 232 are sometimes referred to as underarm perforated sections.

[0062] It will be apparent from the above description that sealed regions 220, 230 and 260 are co-symmetric with correspondingly respective sealed regions 220’, 230’ and 260’ about centerline 22. In the exemplary embodiment shown in FIGS. 3 A and 3B, symmetric pairs of sealed regions - 220 and 220’, 230 and 230’, 260 and 260’ 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. Sealed regions 260 and 260’ are also referred to as auxiliary sealed regions in some embodiments of the invention.

[0063] The inner surfaces of gown 200 can be accessed by pulling apart front and rear bottom edges 64 and 64r and separating wall sections 60 and 60r for donning and wearing gown 200.

[0064] FIG. 4 shows gown 200 in a ready-to-wear state with front wall section 60 and rear wall section 60r shown in a pulled apart state revealing both the front bottom edge 64 and rear bottom edge 64r. Neck opening 242 created by the unsealed portion between upper sealed regions 220 and 220’ is configured for accommodating the wearer’s neck by separating front top edge 62 and rear top edge 62r. First and second sleeves 250 and 250’ respectively are shown in a detached state from the rest of the gown material for allowing manipulation during wearing gown 200. Sleeve 250 is created by severing along perforated section 232 (see FIG. 3A) and separating sealed regions 230 and 260. The proximal end of sealed regions 230 and 260 is denoted by reference numeral 246 and defines a first armpit region of the wearer. Extra gown material below sealed region 260 forms a flap 270 that can be wrapped around the wearer’s body (best shown in FIG. 6).

[0065] In congruity with the above, sleeve 250’ is created by severing along perforated section 232’ (see FIG. 3A) and separating sealed regions 230’ and 260’. The proximal end of sealed regions 230’ and 260’ is denoted by reference numeral 246’ and defines the second armpit region of the wearer. Extra gown material below sealed region 260’ forms a flap 270’ that can be wrapped around the wearer’s body along with flap 270 to complete donning of gown 200 (as further explained below with reference to FIG. 6). The gaps 240 and 240’ can be utilized by the wearer for penetrating their hands through the closed edges at the respective distal ends of sleeves 250 and 250’.

[0066] FIG. 5 illustrates gown 200 after donning by wearer 80 showing a donning option according to an embodiment of the invention. The unsealed portion or gap 242 between sealed regions 220 and 220’ is adapted for accommodating wearer’s neck 84. Sleeves 250 and 250’ 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 250 and 250’ is shown penetrated by wearer’s hands 82 and 82’ . The extra gown material in forms of flaps 270 and 270’ is secured in the rear as further explained below.

[0067] FIG. 6 illustrates the rear or back side of gown 200 after donning by the wearer showing a donning option according to an embodiment of the invention. Rear perforated section 72 is partially visible and can be utilized for tearing along the frangible perforations for removing gown 200 after use. As also shown, flap 270’ is wrapped around the rear of gown 200 over flap 270, wherein flaps 270 and 270’ are secured at the rear by at least one adhesive tape closure or tape 280. In FIG. 6, the adhesive tape 280 is shown placed closed to the center line of the gown 200 and partially covering sealed regions 260’ and 260. In other embodiments, adhesive tape 280 can be placed at other locations for securing flaps 270 and 270’ depending on the range of motion of the wearer or comfort level.

[0068] In alternate embodiments of the invention, flaps 270 and 270’ can be manipulated and secured in a variety of configurations including - securing the flaps in rear by employing multiple tape closure at multiple locations; securing the flaps in the front with tape 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 270 and 270’ can also be left loose on the sides.

[0069] FIG. 7 shows a rear view of gown 300 according to another embodiment of the invention constructed from tube 70 (FIGS. 2A-2C). It will be of course realized that that any of the illustrated gown embodiments can be constructed from either tube 70 or tube 50. Gown 300 is similar to gown 200 (FIGS. 3A-6) discussed herein above in most respects except that sleeves 250’ and 250 feature finger perforation sections 282’ and 282 at the respective distal ends extending inwardly from edges 66’ and 66 respectively. Finger perforation sections 282’ and 282 at the distal end of the sleeves are also referred to as sleeve perforations in some of the embodiments. According to an embodiment of the invention, the sleeve perforation sections 282’ and 282 are typically about 2 inches in length but can vary between 1 to 4 inches.

[0070] FIG. 8 shows gown 300 donned by a wearer. Finger perforation sections 282’ and 282 are configured for facilitating penetration of wearer’s hand through the frangible perforations with ease and to work cooperatively with gaps 240’ and 240 respectively as shown in FIG. 8. As shown, gaps 240 and 240’ serve as thumb openings into the sleeves 250 and 250’ for forming thumb loops, while finger perforation sections 282 and 282’ enable the wearer to insert respective hands 82 and 82’ therethrough. Each thumb loop is intended to retain the sleeve in an extended configuration and prevent the sleeve from riding up the arm, thereby assuring coverage and protection of the entire arm including the wrist region of the wearer during use.

[0071] FIG. 9 shows a rear view of gown 310 according to another embodiment of the invention constructed from tube 70 (FIGS. 2A-2C). Gown 310 is similar to gown 300 (FIGS. 7-8) discussed herein above in most respects except that sleeves 250’ and 250 feature closed arcuate armpit regions 264’ and 264 respectively which provide improved security and seal strength in the high stress armpit region. It will also be noted that in the gown embodiments shown so far (gowns 200, 300 310) the lower rear edge 64r of the gowns 200, 300 and 310 is the leading edge of the tubular structure as denoted by arrow 71 which points towards the lower edge 64r, and the trailing edge 62r forms the upper edge of these gowns. [0072] FIG. 10 shows a rear view of gown 320 according to still another embodiment of the invention wherein an alternate sealing arrangement is shown. In FIG. 10, the machine direction of the tubular structure is reversed and is shown by an upward pointing arrow 73 and the leading edge 64r forms the upper rear edge of gown 320 while the trailing edge 62r forms the lower edge of gown 320. Thus, the lower open end of the gowns can be formed by the leading edges (gowns 200, 300 and 310) or at the trailing edges (gown 320).

[0073] FIG. 11 shows a rear view of gown 330 according to another embodiment of the invention. Gown 330 features sleeves 252’ and 252 comprising upper sealed regions 221’ and 221, and lower sealed regions 231’ and 231 respectively. Sealed regions 221’ and 221 extend inwardly from side edges 66’ and 66 and do not feature a gap or opening at the distal ends thereof; however distal ends of lower sealed regions 231’ and 231 feature gaps 241’ and 241. Gaps 241’ and 241 are revealed after the sleeves 252’ and 252 are separated from the rest of the gown material by severing along perforated sections 232’ and 232. Thus, gown 330 allows a wearer to insert their thumbs through the lower portion of the sleeves at the distal end of sealed regions 231’ and 231, and the wearer can pierce their hands through the finger perforation sections 282’ and 282 for donning gown 330 and complete donning as described hereinabove.

[0074] FIG. 12 shows a rear view of gown 340 according to another embodiment of the invention. Gown 340 features symmetrical tapered sleeves 254’ and 254 that are obtained by sealing the lower section of the sleeves at an incline. As shown in previous embodiments, upper sealed regions 220’ and 220 feature gaps 240’ and 240 at respective distal ends thereof. Lower sealed regions 234’ and 234 extend inwardly at symmetric inclinations from side edges 66’ and 66 respectively such that the distal ends of tapered sleeves 254’ and 254 are relatively constricted in comparison to the proximal ends thereof.

[0075] Sealed tapered regions 264’ and 264 extend inwardly at symmetric angles from edges 66’ and 66 from locations below sealed regions 234’ and 234 respectively. Inclined perforated sections 233’ and 233 extend inwardly from side edges 66’ and 66 respectively. Sleeves 254’ and 254 can be separated from the rest of the gown material by severing along the perforated sections 233’ and 233 respectively. Thereafter, gown 340 can be donned in a manner according to the illustrative embodiment shown in FIGS. 4-6 or alternate donning embodiments discussed above.

[0076] FIG. 13 shows a rear view of gown 350 according to another embodiment of the invention. Gown 350 is similar in construction to gown 300 (FIG. 7) wherein like parts bear like reference numerals; however, gown 350 additionally features strap perforations 284’ and 284 that extend inwardly from side edges 66’ and 66. Strap perforations are referred to as supplemental perforations in some embodiments of the invention. Strap perforations can be severed from the gown material to provide straps 290’ and 290 that can be tied at the back as shown in FIG. 14.

[0077] FIG. 14 shows a rear view of gown 350, showing straps 290’ and 290 tied together by knot 292. [0078] FIG. 15 shows a rear view of gown 360 according to another embodiment of the invention showing a combination of tapered sleeves (254’ and 254), inclined finger perforation sections (283’ and 283), and inclined strap perforations (285’ and 285). Gown 360 features tapered sleeves similar to gown 340 of FIG. 12. Gown 360 additionally features inclined finger perforation sections 283’ and 283 emanating inwardly from side edges 66’ and 66 respectively that enable the wearer to insert his/her hands therethrough during the donning process. The respective inclinations of finger perforation sections 283’ and 283 are configured to support the natural motion of the wearer’s hands while donning gown 360. Inclined strap perforations 285’ and 285 yield straps post-severing to be tied at the back as shown in FIG. 14. In addition, gown 360 also shows arcuate seal regions 266’ and 266 that close off the respective armpit areas for improved security and increased resistance to damage or a compromised sealed region during use.

[0079] FIG. 16 shows a front view of gown 400 according to an exemplary embodiment of the invention. FIG. 16 shows gown 400 constructed from tube 50, however gown 400 could also be constructed from tube 70 with vertical perforations in the rear of the gown for convenient doffing. Gown 400 includes tapered sleeves 48 and 48’ that are symmetrical about centerline 22 and configured to cover the wearer’s arms including the wrist region. Tapered sleeve 48 is defined by an upper sealed region 21 and an inclined dual-lip lower sealed region 29. Similarly, tapered sleeve 48’ is defined by an upper sealed region 21 ’ and an inclined dual-lip lower sealed region 29’. Lower sealed regions 29 and 29’ extend inwardly at symmetric inclinations from a position proximate side edges 16 and 16’ respectively such that the distal ends of tapered sleeves 48 and 48’ are relatively constricted in comparison to the proximal ends thereof. Gaps 43 and 43’ are provided at distal ends of lower sealed regions 29 and 29’.

[0080] Sleeves 48 and 48’ can be separated from the rest of the gown material by severing along the perforated sections 33 and 33’ respectively. Sealed tapered regions 31 and 31’ below perforated sections extend inwardly at symmetric angles from edges 16 and 16’ to seal off free ends of flap regions 52 and 52’ . Gown 400 can be donned in a manner according to the illustrative embodiments discussed above.

[0081] FIG. 17 shows a front view of gown 410 according to an exemplary embodiment of the invention. FIG. 17 shows gown 410 constructed from tube 50, however, any of the gown embodiments shown herein can be constructed from either tube 50 or tube 70. Furthermore, various features shown in different embodiments can be combined unless two features are mutually exclusive or contradictory in nature. FIG. 17 shows tapered sleeves 48 and 48’, wherein proximal ends of inclined seal sections 35 and 37 converge at armpit region 58, and similarly proximal ends of inclined seal sections 35’ and 37’ converge at armpit region 58’. It will be realized that the respective inclinations of sealed regions 35 and 37 are not parallel and intersect at proximal end 58 to define a sealed armpit region. Similarly, sealed regions 35’ and 37’ intersect at proximal end 58’ to define the other sealed armpit region. The configuration shown in FIG. 17 providing improved security and tear resistance in the armpit regions.

[0082] 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 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

What is claimed is:

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 a first side edge, a second side edge, and 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 neck opening defined by a first unsealed region between the first upper sealed region and the second upper sealed region; a first gap provided at a distal end of said first upper sealed region of the first sleeve; a second gap provided at a distal end of said second upper sealed region of the second sleeve; each of said first and second gaps being configured for penetration of at least a first portion of a hand of the wearer therethrough; a rear perforated section provided in the rear panel of the gown proximate a vertical center line, wherein the rear perforated section is configured for facilitating removal of said gown from the body of the wearer.

2. The medical gown according to claim 1, further comprising a first sleeve perforation provided at a distal end of said first sleeve, a second sleeve perforation provided at a distal end of said second sleeve, wherein each of said first and second sleeve perforations being configured for penetration of at least a second portion of the hand of the wearer therethrough.

3. The medical gown according to claim 2, wherein said first and second gaps are respectively proximate to said first and second sleeve perforations, each of said first and second gaps being configured for protruding a thumb portion of the wearer therethrough, and each of said first and second sleeve perforations being configured for protruding a finger portion of the wearer therethrough.

4. The medical gown according to claim 1, wherein each of said first and second gaps at the distal end of the first and second sleeves respectively are configured for protruding a thumb portion of the wearer therethrough, and wherein each of the first and second sleeves forming a loop around said thumb portion of the wearer.

5. The medical gown according to claim 1, wherein the medical gown is comprised of a fluid impermeable material.

6. 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.

7. The medical gown according to claim 1, wherein said neck opening defined by said first unsealed region is greater than 9 inches.

8. The medical gown according to claim 1, wherein said first gap is greater than 1 inch.

9. The medical gown according to claim 1, wherein said second gap is about 2 inches.

10. The medical gown according to claim 1, wherein the length of the first upper sealed region ranges from 25 to 35 inches.

11. The medical gown according to claim 1, wherein the length of the first lower sealed region ranges from 16 to 25 inches.

12. 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.

13. 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 58 inches.

14. The medical gown according to claim 1, wherein the medical gown is constructed from a plastic material.

15. The medical gown according to claim 1, wherein the medical gown is constructed from a bioplastic material.

16. The medical gown according to claim 1, wherein the medical gown is constructed from a non-woven material.

17. The medical gown according to claim 1, wherein the medical gown is constructed from a combination of a plastic and a non-woven material.

18. 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.

19. The medical gown according to claim 1, wherein the medical gown is constructed from a material comprising a blend of: polyethylene resin, a filler, an anti-block additive, and a colorant.

20. The medical gown according to claim 1, wherein the tubular structure is formed of a blown film.

21. The medical gown according to claim 1, wherein a printed message is provided proximate the rear perforated section for instructing the wearer for removing the gown after use.

22. The medical gown according to claims 1, wherein the medical gown is configured for facilitating tearing of the medical gown along said rear perforated section.

23. The medical gown according to claim 1, wherein the tubular structure has a continuous finite length.

24. The medical gown according to claim 1, wherein the tubular structure is symmetrical along a vertical center line.

25. The medical gown according to claim 1, wherein the medical gown is configured to meet at least the minimum level regulatory requirements of

ANSI/AAMI PB70 standard.

26. 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.

27. The medical gown according to claim 26, wherein the first and second gown portions below said first and second sleeves are secured with an adhesive tape after donning of the gown by the wearer.

28. The medical gown according to claim 26, wherein the first and second gown portions below said first and second sleeves are secured at a back of the wearer with an adhesive tape.

29. The medical gown according to claim 26, wherein the first underarm perforated section is shorter than the first lower sealed region of the first sleeve, and second underarm perforated section is shorter than the second lower sealed region of the second sleeve.

30. The medical gown according to claim 26, wherein each of the first and second underarm perforated sections do not extend to an armpit area of the wearer.

31. The medical gown according to claim 26, 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.

32. The medical gown according to claim 31, wherein a proximal end of the first auxiliary sealed region abuts a proximal end of the first lower sealed region, and, a proximal end of the second auxiliary sealed region abuts a proximal end of the second lower sealed region.

33. The medical gown according to claim 31, wherein the first lower sealed region of the first sleeve and the first auxiliary sealed region are parallel, and the second lower sealed region of the second sleeve and the second auxiliary sealed region are parallel.

34.The medical gown according to claim 31, further comprising a first arcuate armpit sealed region connecting proximal ends of the first lower sealed region and the first auxiliary sealed region; and, a second arcuate armpit sealed region connecting proximal ends of the second lower sealed region and the second auxiliary sealed region.

35. The medical gown according to claim 31, wherein said first and second auxiliary sealed regions have a dual lip seal configuration.

36. The medical gown according to claim 1, wherein said first and second lower sealed regions have a dual lip seal configuration.

37. The medical gown according to claim 1, wherein said first and second upper sealed regions have a dual lip seal configuration.

38. The medical gown according to claim 1, wherein the first and second sleeves are substantially straight with a uniform gap between the upper and the lower sealed regions of each of the first and second sleeves.

39. The medical gown according to claim 38, wherein the uniform gap ranges from 9 to 12 inches.

40. The medical gown according to claim 1, wherein each of the first and second sleeves is tapered comprising a constricted distal end relative to a proximal end thereof.

41. The medical gown according to clam 31, further comprising a first supplemental perforation located proximately below the first auxiliary sealed region, and a second supplemental perforation located proximately below the second auxiliary sealed region.

42. The medical gown according to claim 41, wherein said first supplemental perforation being configured to yield a first strap, and said second supplemental perforation being configured to yield a second strap; and, wherein said first and second straps being configured for tying said gown at a back of the wearer.

43. The medical gown according to claim 41, wherein the first sleeve perforation, the first underarm perforated section and the first supplemental perforation are respectively co- symmetric with the second sleeve perforation, the second underarm perforated section and second supplemental perforation.

44. The medical gown according to claim 41, wherein the first sleeve perforation, the first underarm perforated section and the first supplemental perforation extend inwardly from the first side edge of the tubular structure and are approximately perpendicular to the first side edge; and wherein the second sleeve perforation, the second underarm perforated section, and the second supplemental perforation extend inwardly from the second side edge and are approximately perpendicular to the second side edge of the tubular structure.

45. The medical gown according to claim 41, wherein the first sleeve perforation, the first underarm perforated section and the first supplemental perforation extend inwardly downward from the first side edge of the tubular structure and are inclined towards the open bottom end of the gown; and wherein the second sleeve perforation, the second underarm perforated section, and the second supplemental perforation extend inwardly downward from the second side edge of the tubular structure and are inclined towards the open bottom of the gown.

46. 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.

47. 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.

48. 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.