WO2005074791A2 - Medical garment - Google Patents

Medical garment Download PDF

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Publication number
WO2005074791A2
WO2005074791A2 PCT/IL2005/000146 IL2005000146W WO2005074791A2 WO 2005074791 A2 WO2005074791 A2 WO 2005074791A2 IL 2005000146 W IL2005000146 W IL 2005000146W WO 2005074791 A2 WO2005074791 A2 WO 2005074791A2
Authority
WO
WIPO (PCT)
Prior art keywords
film
garment
skin
vest
patch
Prior art date
Application number
PCT/IL2005/000146
Other languages
French (fr)
Other versions
WO2005074791A3 (en
Inventor
Igal Kushnir
Guy Ben-Ezra
Original Assignee
Deepbreeze Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Deepbreeze Ltd. filed Critical Deepbreeze Ltd.
Publication of WO2005074791A2 publication Critical patent/WO2005074791A2/en
Publication of WO2005074791A3 publication Critical patent/WO2005074791A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6834—Means for maintaining contact with the body using vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A61B5/6805—Vests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier

Definitions

  • the present invention relates to devices comprising a flexible film for application to a body surface.
  • Medical devices are often applied to a subject's skin in order to measure or record a parameter of the skin or to apply a stimulus to the skin.
  • Such devices include, for example, thermometers, stethoscopes, electrodes, microphones, and so on. If the device is to be applied to the skin for a short period of time (e.g. a stethoscope), it may be applied manually by the care giver. If the device is to be applied to the skin for a prolonged period of time (e.g. ECG electrodes), the device is usually affixed to the skin.
  • Such means of fixation include, for example, use of straps, embedding the device in a garment worn by the subject, or by means of a vacuum.
  • the present invention provides a thin flexible film that is applied to a subject's skin.
  • the film is formed into a patch or garment, the shape of which allows the film to conform to the skin surface to which it is to be applied.
  • the film is provided with means for firmly applying it to the skin surface.
  • Such means include straps and/or a nipple for connection to a negative pressure source so as to generate a vacuum between the film and the skin surface. Due to the firm attachment of the film to the skin surface, the film forms a smooth surface over the skin surface. After firm application of the film to the skin surface, one or more medical devices, such as a microphone may be applied to the film. The absence of geometrical defects in the film surface allows the devices to be applied firmly to the film surface. In particular, a better airtight seal may be formed between the device and the film than is normally possible when the device is applied directly to the skin surface.
  • the film is preferably acoustically transparent in the frequency range of the body sounds to be detected, which is usually in the frequency range below 1000 Hz.
  • an airtight seal between the microphone and the film often allows an acoustic signal to be recorded from the skin surface having a higher signal to noise ratio than is obtainable when the microphone is applied directly to the skin.
  • the invention provides a medical garment or patch, at least a portion of which is formed from a flexible, air-impervious film, the garment or patch being configured to be directly applied to a region of an individual's skin surface when the garment or patch is donned by an individual.
  • the invention provides a system for applying a flexible film to a body surface comprising:
  • a garment or patch at least a portion of which is formed from an air impervious flexible film and having a nipple for connection to a source of negative pressure to remove air between the film and the body surface when the film is applied to the body surface; and (b) a source of negative pressure.
  • Fig. 1 shows a medical garment in accordance with one embodiment of the invention
  • Fig. 2 shows the garment of Fig. 1 after having been donned by an individual
  • Fig. 3 shows a portion of the garment of Fig. 1 after removal of air from between the film and skin surface
  • Fig. 4 shows application of a medical device to a portion of the garment of Fig. 1
  • Fig. 5 shows a medical garment in accordance with another embodiment of the invention
  • Fig. 6 shows the medical garment of Fig. 5 after having been donned by an individual
  • Fig. 7 shows a medical garment in accordance with another embodiment of the invention having a perforated portion.
  • Fig. 1 shows a medical garment 10 in accordance with one embodiment of the invention.
  • the medical garment 10 is a vest to be worn over a subject's trunk.
  • the vest 10 is shown in a front view in Fig. la and in a rear view Fig. lb. This is by way of example only, and the medical garment may be configured to be adapted to any skin region of the subject.
  • the vest 10 includes a zipper 12 that is opened to allow the subject to don the vest, and is then closed so as to create a tight fit of the vest over the subject's trunk.
  • the vest 10 includes a film 5 formed from an air impervious material such as polyurethane, latex or silicone rubber.
  • the film 5 forms the portion of the vest that is to be applied to a subject's back ( Figure lb).
  • the front of the vest is formed from an inelastic material 6 that may be for example a non-woven cellulose based material.
  • a nipple 16 extends from the film 5 that is configured to be attached to a source of negative pressure.
  • the inset lb shows a portion of the vest 10 and the nipple 16.
  • a sealing surface 14 At the bottom exposed edge of the film 5 is a sealing surface 14 that forms an airtight seal with the skin when firmly pressed against the skin. A similar sealing surface may also be present on the upper exposed edge of the film 5 around the neck region.
  • Fig. 1 shows a portion of the vest 10 and a portion of a sealing surface 14 at an edge of the film.
  • the sealing surface 14 may be formed as a lip extending from the edge as shown in the insert la.
  • the sealing surface may be formed from a biocompatible gel applied between the edge of the film 5 and the subject's skin.
  • the sealing surface may be formed by an adhesive layer applied along the edge of the film.
  • the nipple 16 is used to evacuate a chamber formed by the skin surface, the film 5 and the sealing surface 14.
  • Fig. 2 shows the vest 10 of Fig. 1 after having been donned by a subject 20. The vest 10 is donned with the film 5 over the subject's back in direct contact with the subject's skin.
  • the nipple 16 has been connected to a vacuum pump 22 by means of a vacuum hose 24.
  • the sealing surface or surfaces 14 are then pressed against the skin, so as to create an airtight seal with the skin at the edges of the vest.
  • the vacuum pump 22 is then activated in order to remove air trapped in the space bounded by the film 5, the sealing lips 14 and the subject's skin. This causes the film 5 to be firmly applied to the subject's skin and to conform to the topography of the subject's back.
  • Fig. 3 shows the film 5 after having been affixed to a subject's skin 30 after applying a negative pressure via the nipple 16 to remove air trapped between the film 5 and the skin 30.
  • a valve 32 located in the nipple 16 may be closed so that the hose 24 may be disconnected from the nipple 16 without loss of vacuum in the space between the film 5 and the skin 30.
  • Fig. 4 shows application of a vacuum dome 40 to the film 5, after removal of air from the space between the film 5 and the skin 30.
  • the dome 40 is formed from an air impervious material.
  • a sealing ring 43 forms an airtight seal between the dome 40 and the film 5.
  • a nipple 36 allows the interior 38 of the dome 40 to be evacuated by means of a vacuum pump (not shown).
  • the dome 40 may be used to affix a medical device such as a microphone 42.
  • Fig. 5 shows a medical garment 48 in accordance with another embodiment of the invention.
  • the medical garment 48 is a vest to be worn over a subject's trunk.
  • the vest 48 is shown in a front view in Fig. 5a and in a rear view Fig. 5b.
  • the embodiment of Fig. 5 is provided with a plurality of straps 44.
  • Each strap 44 has a left portion 45 and a separate right portion 46.
  • the left portion 45 and the right portion 46 are joined together by means of a buckle 47 that allows the length of the straps 44 to be selected.
  • the straps 44 are opened to allow the subject don the vest, and are then closed so as to create a tight fit of the vest over the subject's trunk.
  • the vest 48 includes a film 5 formed from an air impervious material such as polyurethane, latex or silicone rubber.
  • the film 5 forms the portion of the vest that is to be applied to a subject's back ( Figure 5b).
  • the front of the vest is formed from an inelastic material 6 that may be for example a non-woven cellulose based material.
  • Fig. 6 shows the vest 48 after having been donned by a subject 21.
  • the vest 48 is donned with the film 5 over the subject's back in direct contact with the skin.
  • Fig. 7 shows a medical garment 33 in accordance with another embodiment of the invention.
  • the medical garment 33 is a vest to be worn over an individual's trunk.
  • the vest 33 is shown in a front view in Fig. 7a and in a rear view in Fig. 7b. This is by way of example only, and the film may be adapted to be applied to any skin region of the individual.
  • the vest 33 includes a zipper 34 that is opened to allow the individual to don the vest, and is then closed so as to create a tight fit of the vest over the individual's trunk.
  • the vest 33 includes a film 31 formed from an air impervious material such as polyurethane, latex, or silicone rubber.
  • the entire vest 33, except for the zipper 34 is made from a single sheet of the air impervious material.
  • the vest 33 has a back portion 35 that is positioned over an individual's back when the vest 33 is donned by the individual.
  • the back portion 35 has a plurality of perforations 37.
  • the perforations 37 allow different sections of the back portion 35 to be stretched by different amounts without causing wrinkling of the back portion.
  • the perforations may have a diameter of 1 mm.
  • the perforations may be arranged in a lattice having a spacing between adjacent perforations of 5mm.

Abstract

A medical garment (10) or patch, at least a portion of which is formed from a flexible, air-impervious film (5). The garment or patch is configured to allow the film to be directly applied to a region of an individual's skin surface (30) when the garment or patch is donned by an individual. The garment may be used to apply a medical device (42) to the body.

Description

MEDICAL GARMENT
FIELD OF THE INVENTION The present invention relates to devices comprising a flexible film for application to a body surface.
BACKGROUND OF THE INVENTION Medical devices are often applied to a subject's skin in order to measure or record a parameter of the skin or to apply a stimulus to the skin. Such devices include, for example, thermometers, stethoscopes, electrodes, microphones, and so on. If the device is to be applied to the skin for a short period of time (e.g. a stethoscope), it may be applied manually by the care giver. If the device is to be applied to the skin for a prolonged period of time (e.g. ECG electrodes), the device is usually affixed to the skin. Such means of fixation include, for example, use of straps, embedding the device in a garment worn by the subject, or by means of a vacuum. In many cases, functioning of a device applied to a subject's skin requires firm contact between the device and the skin. In practice, however, the presence of skin defects, such as hair, pimples or wrinkles, prevent firm application of the device to the skin. The problem is especially significant when a device is to be applied to the skin by vacuum. The presence of skin defects often prevents the formation of an airtight seal between the device and the skin. SUMMARY OF THE INVENTION The present invention provides a thin flexible film that is applied to a subject's skin. The film is formed into a patch or garment, the shape of which allows the film to conform to the skin surface to which it is to be applied. The film is provided with means for firmly applying it to the skin surface. Such means include straps and/or a nipple for connection to a negative pressure source so as to generate a vacuum between the film and the skin surface. Due to the firm attachment of the film to the skin surface, the film forms a smooth surface over the skin surface. After firm application of the film to the skin surface, one or more medical devices, such as a microphone may be applied to the film. The absence of geometrical defects in the film surface allows the devices to be applied firmly to the film surface. In particular, a better airtight seal may be formed between the device and the film than is normally possible when the device is applied directly to the skin surface. If the device is a microphone, the film is preferably acoustically transparent in the frequency range of the body sounds to be detected, which is usually in the frequency range below 1000 Hz. In this case, an airtight seal between the microphone and the film, often allows an acoustic signal to be recorded from the skin surface having a higher signal to noise ratio than is obtainable when the microphone is applied directly to the skin. Thus, in its first aspect, the invention provides a medical garment or patch, at least a portion of which is formed from a flexible, air-impervious film, the garment or patch being configured to be directly applied to a region of an individual's skin surface when the garment or patch is donned by an individual. In its second aspect, the invention provides a system for applying a flexible film to a body surface comprising:
(a) A garment or patch at least a portion of which is formed from an air impervious flexible film and having a nipple for connection to a source of negative pressure to remove air between the film and the body surface when the film is applied to the body surface; and (b) a source of negative pressure.
BRIEF DESCRIPTION OF THE DRAWINGS In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non- limiting example only, with reference to the accompanying drawings, in which: Fig. 1 shows a medical garment in accordance with one embodiment of the invention; Fig. 2 shows the garment of Fig. 1 after having been donned by an individual; Fig. 3 shows a portion of the garment of Fig. 1 after removal of air from between the film and skin surface; Fig. 4 shows application of a medical device to a portion of the garment of Fig. 1; Fig. 5 shows a medical garment in accordance with another embodiment of the invention; Fig. 6 shows the medical garment of Fig. 5 after having been donned by an individual; and Fig. 7 shows a medical garment in accordance with another embodiment of the invention having a perforated portion.
DETAILED DESCRIPTION OF THE INVENTION Fig. 1 shows a medical garment 10 in accordance with one embodiment of the invention. In the embodiment of Fig. 1, the medical garment 10 is a vest to be worn over a subject's trunk. The vest 10 is shown in a front view in Fig. la and in a rear view Fig. lb. This is by way of example only, and the medical garment may be configured to be adapted to any skin region of the subject. The vest 10 includes a zipper 12 that is opened to allow the subject to don the vest, and is then closed so as to create a tight fit of the vest over the subject's trunk. The vest 10 includes a film 5 formed from an air impervious material such as polyurethane, latex or silicone rubber. The film 5 forms the portion of the vest that is to be applied to a subject's back (Figure lb). The front of the vest is formed from an inelastic material 6 that may be for example a non-woven cellulose based material. A nipple 16 extends from the film 5 that is configured to be attached to a source of negative pressure. The inset lb shows a portion of the vest 10 and the nipple 16. At the bottom exposed edge of the film 5 is a sealing surface 14 that forms an airtight seal with the skin when firmly pressed against the skin. A similar sealing surface may also be present on the upper exposed edge of the film 5 around the neck region. The inset Fig. la shows a portion of the vest 10 and a portion of a sealing surface 14 at an edge of the film. The sealing surface 14 may be formed as a lip extending from the edge as shown in the insert la. Alternatively, the sealing surface may be formed from a biocompatible gel applied between the edge of the film 5 and the subject's skin. As yet another alternative, the sealing surface may be formed by an adhesive layer applied along the edge of the film. As explained below, the nipple 16 is used to evacuate a chamber formed by the skin surface, the film 5 and the sealing surface 14. Fig. 2 shows the vest 10 of Fig. 1 after having been donned by a subject 20. The vest 10 is donned with the film 5 over the subject's back in direct contact with the subject's skin. The nipple 16 has been connected to a vacuum pump 22 by means of a vacuum hose 24. The sealing surface or surfaces 14 are then pressed against the skin, so as to create an airtight seal with the skin at the edges of the vest. The vacuum pump 22 is then activated in order to remove air trapped in the space bounded by the film 5, the sealing lips 14 and the subject's skin. This causes the film 5 to be firmly applied to the subject's skin and to conform to the topography of the subject's back. Fig. 3 shows the film 5 after having been affixed to a subject's skin 30 after applying a negative pressure via the nipple 16 to remove air trapped between the film 5 and the skin 30. A valve 32 located in the nipple 16 may be closed so that the hose 24 may be disconnected from the nipple 16 without loss of vacuum in the space between the film 5 and the skin 30. Fig. 4 shows application of a vacuum dome 40 to the film 5, after removal of air from the space between the film 5 and the skin 30. The dome 40 is formed from an air impervious material. A sealing ring 43 forms an airtight seal between the dome 40 and the film 5. A nipple 36 allows the interior 38 of the dome 40 to be evacuated by means of a vacuum pump (not shown). The dome 40 may be used to affix a medical device such as a microphone 42. Application of the dome and device 40 to the film 5 is more hygienic than applying the dome 40 and device 42 directly to the skin surface. Fig. 5 shows a medical garment 48 in accordance with another embodiment of the invention. In the embodiment of Fig. 5, the medical garment 48 is a vest to be worn over a subject's trunk. The vest 48 is shown in a front view in Fig. 5a and in a rear view Fig. 5b. The embodiment of Fig. 5 is provided with a plurality of straps 44. Each strap 44 has a left portion 45 and a separate right portion 46. The left portion 45 and the right portion 46 are joined together by means of a buckle 47 that allows the length of the straps 44 to be selected. The straps 44 are opened to allow the subject don the vest, and are then closed so as to create a tight fit of the vest over the subject's trunk. The vest 48 includes a film 5 formed from an air impervious material such as polyurethane, latex or silicone rubber. The film 5 forms the portion of the vest that is to be applied to a subject's back (Figure 5b). The front of the vest is formed from an inelastic material 6 that may be for example a non-woven cellulose based material. Fig. 6 shows the vest 48 after having been donned by a subject 21. The vest 48 is donned with the film 5 over the subject's back in direct contact with the skin. After donning, the lengths of the elastic straps 44 are determined so that the vest 48 fits snugly on the subject and the film 5 is applied firmly to the subject's skin. A medical device may then be applied to the film 5 as described above for the embodiment of Fig. 1. Fig. 7 shows a medical garment 33 in accordance with another embodiment of the invention. In the embodiment of Fig. 7, the medical garment 33 is a vest to be worn over an individual's trunk. The vest 33 is shown in a front view in Fig. 7a and in a rear view in Fig. 7b. This is by way of example only, and the film may be adapted to be applied to any skin region of the individual. The vest 33 includes a zipper 34 that is opened to allow the individual to don the vest, and is then closed so as to create a tight fit of the vest over the individual's trunk. The vest 33 includes a film 31 formed from an air impervious material such as polyurethane, latex, or silicone rubber. The entire vest 33, except for the zipper 34 is made from a single sheet of the air impervious material. As shown in Fig. 7b, the vest 33 has a back portion 35 that is positioned over an individual's back when the vest 33 is donned by the individual. The back portion 35 has a plurality of perforations 37. The perforations 37 allow different sections of the back portion 35 to be stretched by different amounts without causing wrinkling of the back portion. For example, the perforations may have a diameter of 1 mm. The perforations may be arranged in a lattice having a spacing between adjacent perforations of 5mm. Thus, as shown in Fig. 7c, when the vest 33 is tightly donned by individual 39, the back portion 35 of the vest 33 stretches so that it tightly conforms to the topography of the individual's back. A medical device may then be applied to the film 31 as described above for the embodiment of Fig. 1.

Claims

CLAIMS:
1. A medical garment or patch, at least a portion of which is formed from a flexible, air-impervious film, the garment or patch being configured to allow the film to conform to a region of an individual's skin surface when the garment or patch is donned by an individual.
2. The garment or patch according to Claim 1 wherein the film is made from polyurethane, latex or silicone rubber.
3. The garment or patch according to Claim 1 including a nipple for connection to a source of negative pressure to remove air between the film and the skin surface.
4. The garment or patch according to Claim 1 wherein the means for conforming at least a portion of the film to the skin surface includes straps.
5. The garment according to Claim 1 wherein the film is acoustically transparent in at least a portion of the frequency range below 1000 Hz.
6. The garment or path according to Claim 1, wherein the garment has a portion including a plurality of perforations.
7. The garment according to Claim 1 in the form of a vest.
8. A system for applying a flexible film to a body surface comprising: (a) A garment or patch at least a portion of which is formed from an air impervious flexible film and having a nipple for connection to a source of negative pressure to remove air between the film and the body surface when the film is applied to the body surface; and (b) a source of negative pressure.
9. The system according to Claim 8 wherein the film is made from polyurethane or latex.
10. The system according to Claim 8 wherein the film is acoustically transparent in at least a portion of the frequency range below 1000 Hz.
PCT/IL2005/000146 2004-02-04 2005-02-06 Medical garment WO2005074791A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/771,147 US20050177919A1 (en) 2004-02-04 2004-02-04 Medical garment
US10/771,147 2004-02-04

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WO2005074791A2 true WO2005074791A2 (en) 2005-08-18
WO2005074791A3 WO2005074791A3 (en) 2005-10-06

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