US5207652A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Medical apparatus fixation and infection control device
Assignee: Bioderm Inc
•
Filing: 1991-10-23
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Granted: 1993-05-04
•
Expires: 2011-10-23
Abstract
Abstract A device and composition securely affixes an invasive medical apparatus to an entrance site and controls infections associated with the infiltration of microbes along the external walls of such apparatus. Provided in sterile form, the device takes various shapes and sizes and is configured for use with various sizes and types of invasive medical apparatus. The device can incorporate a hydrocolloid composition which, by virtue of is adhesive properties, holds that device in place at a skin entrance site. Alternatively, fixation is effected by adhesive provided on mating surfaces of the device or by thin-film, adhesive leaves. The device achieves a mechanically occlusive seal, a constant presence of medically active substances such as antiseptics and antibiotics at an apparatus skin entrance site, and a substantially rigid attachment of the apparatus to the area around a penetration site which limits the in-and-out motion and accompanying microbial infiltration common in the use of indwelling invasive medical apparatus. The device is particularly useful with catheters, cannulae, drainage devices, and pacemaker wires.
Inventors
- 👤 Dennis M. Kay
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 21:38
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/02; A61M2025/0206; A61M2025/024; Y; Y10; Y10S; Y10S128/00; Y10S128/26
Claims Analysis
Total Claims: 45
Claim 1
Independent Claim
97 words
A fixation and infection control device for use with invasive medical apparatus, comprising (a) a flexible barrier body being a pre-determined shape which is impregnated with at least one medically active substance and has (i) an aperture configured for sealably surrounding said invasive medical apparatus, (ii) a first mating surface for joining said barrier body to skin and (iii) a second mating surface for joining said barrier body to said invasive medical apparatus; and (b) means for sealably attaching said barrier body to said invasive medical apparatus and said skin so that a microbe-impermeable seal is formed.
Claim 2
Dependent Claim
97 words
A fixation and infection control device for use with invasive medical apparatus, comprising (a) a flexible barrier body being a pre-determined shape which is impregnated with at least one medically active substance and has (i) an aperture configured for sealably surrounding said invasive medical apparatus, (ii) a first mating surface for joining said barrier body to skin and (iii) a second mating surface for joining said barrier body to said invasive medical apparatus; and (b) means for sealably attaching said barrier body to said invasive medical apparatus and said skin so that a microbe-impermeable seal is formed.
Claim 3
Dependent Claim
17 words
The device of claim 1, wherein said medically active substance is releasably provided within said barrier body.
Claim 4
Dependent Claim
41 words
The device of claim 1, wherein said barrier body is sufficiently rigid so that movement of said invasive medical apparatus with respect to said skin and with respect to an entry site of said apparatus through said skin is effectively prevented.
Claim 5
Dependent Claim
12 words
The device of claim 1, wherein said invasive medical apparatus is indwelling.
Claim 6
Dependent Claim
24 words
The device of claim 1, wherein said means for attaching said barrier body is an adhesive disposed on said first and second mating surfaces.
Claim 7
Dependent Claim
18 words
The device of claim 1, further comprising means (iv) for additionally securing said barrier body to said skin.
Claim 8
Dependent Claim
20 words
The device of claim 1, further comprising means (v) for additionally securing said barrier body to said invasive medical apparatus.
Claim 9
Dependent Claim
13 words
The device of claim 7 wherein said means (v) comprises a closure ring.
Claim 10
Dependent Claim
12 words
The device of claim 8 wherein said means (v) comprises a flange.
Claim 11
Dependent Claim
12 words
The device of claim 8 wherein said closure ring comprises a ratchet.
Claim 12
Dependent Claim
14 words
The device of claim 6 wherein said means (iv) comprises an adhesive-backed thin film.
Claim 13
Dependent Claim
20 words
The device of claim 11 wherein said adhesive-backed thin film comprises a plurality of leaves disposed on said barrier body.
Claim 14
Dependent Claim
41 words
The device of claim 12, wherein said thin film leaves are provided with release backings for protecting said adhesive until application of said device and for facilitating the sterile transfer of said device to said invasive medical apparatus and said skin.
Claim 15
Dependent Claim
38 words
The device of claim 1, wherein said barrier body is provided with release backings for protecting said mating surfaces and for protecting said means for sealably attaching said barrier body to said invasive medical apparatus and said skin.
Claim 16
Dependent Claim
12 words
The device of claim 14, wherein said release backings are substantially U-shaped.
Claim 17
Dependent Claim
13 words
The device of claim 1, wherein said medically active substance is an antiseptic.
Claim 18
Dependent Claim
13 words
The device of claim 1, wherein said medically active substance is an antibiotic.
Claim 19
Dependent Claim
13 words
The device of claim 1, wherein said medically active substance is a pharmaceutical.
Claim 20
Dependent Claim
13 words
The device of claim 1, wherein said medically active substance is a hormone.
Claim 21
Dependent Claim
14 words
The device of claim 1, wherein said barrier body is conformable to anatomic shapes.
Claim 22
Dependent Claim
18 words
The device of claim 1, wherein said barrier body is conformable to the area surrounding a urethral meatus.
Claim 23
Dependent Claim
12 words
The device of claim 1, wherein said barrier body comprises a hydrocolloid.
Claim 24
Dependent Claim
18 words
The device of claim 22, wherein said hydrocolloid comprises 70% nitrile adhesive, 20% pectin and 10% povidone iodine.
Claim 25
Dependent Claim
19 words
The device of claim 22, wherein said hydrocolloid comprises 60-80% nitrile adhesive, 10-25% pectin and 10-20 % povidone iodine.
Claim 26
Dependent Claim
12 words
The device of claim 22, wherein said hydrocolloid comprises 60% polyisobutylene, 30%
Claim 27
Dependent Claim
17 words
The device of claim 22, wherein said hydrocolloid comprises 50-80% polyisobutylene, 20-40% pectin and 5-15% povidone iodine.
Claim 28
Dependent Claim
18 words
The device of claim 22, wherein said hydrocolloid comprises 70% nitrile adhesive, 20% pectin and 10% benzalkonium chloride.
Claim 29
Dependent Claim
18 words
The device of claim 22, wherein said hydrocolloid comprises 70-80% nitrile adhesive, 20-29% pectin and 1/2-5% benzalkonium chloride.
Claim 30
Dependent Claim
17 words
The device of claim 22, wherein said hydrocolloid comprises 60% polyisobutylene, 30% pectin and 10% benzalkonium chloride.
Claim 31
Dependent Claim
17 words
The device of claim 22, wherein said hydrocolloid comprises 50-65% polyisobutylene, 25-35% pectin and 1-10% benzalkonium chloride.
Claim 32
Dependent Claim
23 words
The device of claim 1, wherein said barrier body compresses a wafer of cross-linked polyethylcellulose and polymethylcellulose impregnated with a medically active substance.
Claim 33
Dependent Claim
19 words
The device of claim 1, wherein said barrier body comprises any bioerodible polymer compatible with skin and medical applications.
Claim 34
Independent Claim
35 words
The device of claims 4, wherein said fixation and control device is configured to be applicable to and removable from said indwelling catheter without substantial movement of said catheter with respect to said entry site.
Claim 35
Dependent Claim
19 words
The device of claim 2, wherein said medically active substance releases from said barrier body at a controlled rate.
Claim 36
Dependent Claim
48 words
The device of claim 2, wherein said medically active substance releases from said barrier body at a rate sufficient to deliver said substance to the penetration site of said apparatus and to said mating surfaces in amounts effective to carry out the desired function of said active substance.
Claim 37
Dependent Claim
78 words
A fixation and infection control device for use with invasive medical apparatus, comprised of a flexible barrier body being a pre-determined shape comprising an adhesive material, wherein said adhesive material is impregnated with a medically active substance, and having (i) an aperture configured for sealably surrounding an invasive medical apparatus, (ii) a first mating surface for joining said barrier body to skin, and (iii) a second mating surface for joining said barrier body to said invasive medical apparatus.
Claim 38
Dependent Claim
78 words
A fixation and infection control device for use with invasive medical apparatus, comprised of a flexible barrier body being a pre-determined shape comprising an adhesive material, wherein said adhesive material is impregnated with a medically active substance, and having (i) an aperture configured for sealably surrounding an invasive medical apparatus, (ii) a first mating surface for joining said barrier body to skin, and (iii) a second mating surface for joining said barrier body to said invasive medical apparatus.
Claim 39
Dependent Claim
17 words
The device of claim 36, wherein said medically active substance is releasably provided within said barrier body.
Claim 40
Dependent Claim
14 words
The device of claim 36, wherein said first and second mating surfaces are contiguous.
Claim 41
Dependent Claim
41 words
The device of claim 36, wherein said barrier body is sufficiently rigid so that movement of said invasive medical apparatus with respect to said skin and with respect to an entry site of said apparatus through said skin is effectively prevented.
Claim 42
Independent Claim
28 words
The device of claims 1 or 36, wherein said invasive medical apparatus is selected from the group consisting of catheters, cannulae, tracheostomy tubes, drainage devices and pacemaker wires.
Claim 43
Dependent Claim
35 words
The device of claim 36, wherein said fixation and control device is configured to be applicable to and removable from said indwelling catheter without substantial movement of said catheter with respect to said entry site.
Claim 44
Dependent Claim
19 words
The device of claim 36, wherein said medically active substance releases from said barrier body at a controlled rate.
Claim 45
Dependent Claim
48 words
The device of claim 37, wherein said medically active substance releases from said barrier body at a rate sufficient to deliver said substance to the penetration site of said apparatus and to said mating surfaces in amounts effective to carry out the desired function of said active substance.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-05-03 | 1996-11-02 | 1997-05-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-05-03 | 2000-11-02 | 2001-05-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-05-03 | 2004-11-02 | 2005-05-04 | $7700.00 | Window Closed / Lapsed |