# US 11,890,236 B2 · Enclosures including systems and methods thereof for establishing a sterile environment for a medical procedure > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,890,236 B2 - Document ID: US11890236B2 - Status: Granted - Kind: B2 - Application number: 17/207,372 - Filed: 2021-03-19 - Published: 2021-09-23 - Granted: 2024-02-06 - Earliest claimed: 2020-03-19 - Assignees: Bard Access Systems, Inc. - Applicants: Bard Access Systems, Inc. - Inventors: Teresa Ta; Michael Davis; Kyle G. Thornley; James D. Beal; Daniel B. Blanchard; Glade H. Howell - Web page: https://patentgrep.com/patent/US11890236B2 ## CPC - A61G 10/005: {Isolators, i.e. enclosures generally comprising flexible walls for maintaining a germ-free environment} - A61B 42/10: Surgical gloves - A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment - A61G 10/023: {Rooms for the treatment of patients at over- or under-pressure or at a variable pressure} - A61B 2046/205: {Adhesive drapes} - A61B 2090/401: {using air flow} - A61G 13/108: {Means providing sterile air at a surgical operation table or area (treatment rooms A61G10/00; instruments or implements for sterile operation A61B90/00; sterilisation of air A61L9/00; purification of air in air-conditioning systems F24F3/16, F24F8/00)} - A61G: TRANSPORT, PERSONAL CONVEYANCES OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS (appliances for aiding patients or disabled persons to walk A61H3/00); OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES (embalming corpses A01N1/00) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Disclosed are enclosures for establishing a sterile environment over a patient for a medical procedure, as well as systems and methods thereof. An enclosure can include an expandable portion of a barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure and a patient-interfacing portion of the barrier. The enclosure can also include a support system coupled to the patient-interfacing portion of the barrier in some embodiments. The patient-interfacing portion of the barrier can include one or more fenestrations for placement directly over one or more areas of interest of the patient, as well as for access to the areas of interest from within the sterile environment. When present, the support system can flank the fenestration. The support system is configured to support the enclosure on a surface when placed over an appendage of the patient or a main body of the patient. ## Claims ### Claim 1 An enclosure for establishing a sterile environment over a patient for a medical procedure, comprising: an expandable portion of a barrier separating the sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure, the expandable portion of the barrier configured to expand from an unexpanded state to an expanded state for working within the sterile environment; a patient-interfacing portion of the barrier including a fenestration configured for placement directly over an area of interest of the patient, the fenestration having a sealed state and an unsealed state for access to the area of interest from within the sterile environment; and a support system coupled to the patient-interfacing portion of the barrier flanking the fenestration, the support system configured to support the enclosure on a surface when the patient-interfacing portion is placed over an appendage of the patient or a main body of the patient, the patient positioned on the surface in any one of a number of anatomical positions. ### Claim 2 (depends on 1) The enclosure of claim 1, wherein the support system is configured to expand from the unexpanded state to the expanded state in concert with the expandable portion of the barrier. ### Claim 3 (depends on 1) The enclosure of claim 1, wherein the support system is configured to expand from the unexpanded state to the expanded state independent of the expandable portion of the barrier. ### Claim 4 (depends on 1) The enclosure of claim 1, further comprising a pair of framed ends of the enclosure configured to support the expandable portion of the barrier, each framed end of the pair of framed ends configured to lie down on the patient-interfacing portion of the barrier in the unexpanded state of the barrier and extend vertically from the patient-interfacing portion of the barrier in the expanded state of the barrier. ### Claim 5 (depends on 1) The enclosure of claim 1, further comprising an air inlet fluidly connected to an inside of the enclosure configured for introducing filtered air thereto for inflating the expandable portion of the barrier from the unexpanded state to the expanded state or maintaining a greater pressure inside of the enclosure than outside of the enclosure. ### Claim 6 (depends on 5) The enclosure of claim 5, further comprising an inline high-efficiency particulate-arresting (“HEPA”) air filter including an optional antimicrobial coating on a filter medium of the HEPA air filter, the HEPA air filter configured to prevent microbial contamination of the sterile environment inside of the enclosure. ### Claim 7 (depends on 1) The enclosure of claim 1, wherein the fenestration includes an outer seal over a patient-interfacing surface of the patient-interfacing portion of the barrier in the sealed state of the fenestration. ### Claim 8 (depends on 7) The enclosure of claim 7, wherein a perimeter of the patient-interfacing surface of the patient-interfacing portion of the barrier around the fenestration includes an adhesive configured to adhere the patient-interfacing portion of the barrier to the patient with the perimeter of the fenestration around the area of interest subsequent to sterilization thereof, the outer seal of the fenestration configured to protect and maintain an integrity of the adhesive prior to use. ### Claim 9 (depends on 7) The enclosure of claim 7, wherein the fenestration includes an inner seal over an inner surface of the patient-interfacing portion of the barrier in the sealed state of the fenestration, the inner seal of the fenestration configured to be removed subsequent to adhering the patient-interfacing portion of the barrier to the patient, thereby maintaining the sterile environment over the patient. ### Claim 10 (depends on 1) The enclosure of claim 1, further comprising one or more pairs of long-sleeved gloves integrated into the expandable portion of the barrier configured to be worn by a clinician when performing the medical procedure within the sterile environment. ### Claim 11 (depends on 1) The enclosure of claim 1, further comprising one or more closed-ended tubes integrated into the expandable portion of the barrier configured to accept insertion of a probe for use during the medical procedure within the sterile environment. ### Claim 12 (depends on 1) The enclosure of claim 1, further comprising one or more pockets integrated into the expandable portion of the barrier configured to hold procedural equipment or supplies for the medical procedure, the one or more pockets inside of the enclosure, outside of the enclosure, or a combination thereof. ### Claim 13 (depends on 1) The enclosure of claim 1, further comprising an introducing means for introducing additional procedural equipment or supplies into the sterile environment inside of the enclosure from the non-sterile environment outside of the enclosure. ### Claim 14 A system for establishing a sterile environment over a patient for a medical procedure, comprising: an enclosure for placement over the patient including: an expandable portion of a barrier separating the sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure, the expandable portion of the barrier configured to expand from an unexpanded state to an expanded state for working within the sterile environment; a patient-interfacing portion of the barrier including a fenestration configured for placement directly over an area of interest of the patient, the fenestration having a sealed state and an unsealed state for access to the area of interest from within the sterile environment; and a support system coupled to the patient-interfacing portion of the barrier flanking the fenestration, the support system configured to support the enclosure on a surface when the patient-interfacing portion is placed over an appendage of the patient or a main body of the patient, the patient positioned on the surface in any one of a number of anatomical positions; and procedural equipment or supplies for the medical procedure in the sterile environment inside of the enclosure. ### Claim 15 (depends on 14) The system of claim 14, wherein the fenestration includes an outer seal over a patient-interfacing surface of the patient-interfacing portion of the barrier in the sealed state of the fenestration. ### Claim 16 (depends on 15) The system of claim 15, wherein a perimeter of the patient-interfacing surface of the patient-interfacing portion of the barrier around the fenestration includes an adhesive configured to adhere the patient-interfacing portion of the barrier to the patient with the perimeter of the fenestration around the area of interest subsequent to sterilization thereof, the outer seal of the fenestration configured to protect and maintain an integrity of the adhesive prior to use. ### Claim 17 (depends on 15) The system of claim 15, wherein the fenestration includes an inner seal over an inner surface of the patient-interfacing portion of the barrier in the sealed state of the fenestration, the inner seal of the fenestration configured to be removed subsequent to adhering the patient-interfacing portion of the barrier to the patient, thereby maintaining the sterile environment over the patient. ### Claim 18 (depends on 14) The system of claim 14, wherein the procedural equipment includes one or more puncturing devices, one or more guidewires selected from access guidewires, maneuver guidewires, and rail guidewires, one or more catheters, one or more syringes, or a combination thereof. ### Claim 19 (depends on 14) The system of claim 14, wherein the supplies include one or more packages of an antiseptic, saline, or a medicament, one or more swabs, gauze, one or more drapes, or a combination thereof. ### Claim 20 A method of a system for establishing a sterile environment over a patient for a medical procedure, comprising: placing an enclosure over an appendage of the patient or a main body of the patient such that a fenestration of a patient-interfacing portion of a barrier of the enclosure is directly over an area of interest of the patient; expanding an expandable portion of the barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure from an unexpanded state to an expanded state; and working in the sterile environment to perform the medical procedure, wherein the enclosure includes a support system coupled to the patient-interfacing portion of the barrier flanking the fenestration, the support system configured to support the enclosure on a surface when: the patient-interfacing portion is placed over the appendage of the patient or the main body of the patient, and the patient is positioned on the surface in any one of a number of anatomical positions. ### Claim 21 (depends on 20) The method of claim 20, wherein expanding the expandable portion of the barrier includes lifting each framed end of a pair of framed ends of the enclosure from the patient-interfacing portion of the barrier in the unexpanded state of the expandable portion of the barrier to form the expanded state thereof. ### Claim 22 (depends on 20) The method of claim 20, wherein expanding the expandable portion of the barrier includes introducing filtered air into the inside of the enclosure with an air inlet fluidly connected to the inside of the enclosure. ### Claim 23 (depends on 22) The method of claim 22, wherein introducing the filtered air into the inside of the enclosure with the air inlet also introduces the filtered air into the support system coupled to the patient-interfacing portion of the barrier that flanks both the fenestration and the appendage or main body of the patient, thereby expanding the support system from an unexpanded state to an expanded state in concert with the expandable portion of the barrier. ### Claim 24 (depends on 20) The method of claim 20, further comprising: removing an outer seal of the fenestration from a patient-interfacing surface of the patient-interfacing portion of the barrier, thereby exposing a perimeter around the fenestration having an adhesive on the patient-interfacing surface; and adhering the patient-interfacing portion of the barrier to the patient with the perimeter of the fenestration around the area of interest. ### Claim 25 (depends on 24) The method of claim 24, further comprising removing an inner seal of the fenestration from an inner surface of the patient-interfacing portion of the barrier after adhering the patient-interfacing portion of the barrier to the patient, thereby maintaining the sterile environment over the patient.