US5443781A
Expired / Lapsed
US
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Method of preparing disposable sheath with optically transparent windows formed continuously integral therewith
Assignee: Vention Medical Advanced Components Inc
•
Filing: 1994-04-08
•
Granted: 1995-08-22
•
Expires: 2014-04-08
Abstract
Abstract Sterile disposable coverings for endoscopes and similar optical medical instruments are disclosed together with a method for preparing such coverings. By forming a heated polymeric film with a mandrel of appropriate shape and dimensions, relatively long-length, very small diameter, closely-fitting, thin-walled sleeves are produced, each having a thin, substantially inelastic, optically transparent window formed continuously integral with the sleeve at or proximate to the closed, distal end of the sleeve.
Inventors
- 👤 Mark A. Saab
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:34
CPC Classifications
A; A61; A61B; A61B1/00; A61B1/00142; A61B1/00064; A61B1/0011; A61B1/00071; A61B1/00073
Claims Analysis
Total Claims: 69
Claim 1
Independent Claim
158 words
Method of preparing an elongated, tubular sleeve for covering an optical medical instrument used for internal body applications, said method comprising the steps of: (a) heating a first film of a polymeric material to a malleable temperature; (b) inserting into said heated first film the distal end of an elongated forming tool comprising a proximal end, a distal end, and sidewalls joining said proximal and distal ends, and at least one shaped surface at or near the distal end of said forming tool, said surface being shaped so as to conform with the geometry of the optical portion of said medical instrument, causing the film to stretch into an elongated shape comprising a closed distal end, an open proximal end, sidewalls around and conforming to the sidewalls of said forming tool, and an optically transparent window adjacent each said shaped surface of said forming tool; and (c) removing the forming tool from said film to create said sleeve.
Claim 2
Dependent Claim
158 words
Method of preparing an elongated, tubular sleeve for covering an optical medical instrument used for internal body applications, said method comprising the steps of: (a) heating a first film of a polymeric material to a malleable temperature; (b) inserting into said heated first film the distal end of an elongated forming tool comprising a proximal end, a distal end, and sidewalls joining said proximal and distal ends, and at least one shaped surface at or near the distal end of said forming tool, said surface being shaped so as to conform with the geometry of the optical portion of said medical instrument, causing the film to stretch into an elongated shape comprising a closed distal end, an open proximal end, sidewalls around and conforming to the sidewalls of said forming tool, and an optically transparent window adjacent each said shaped surface of said forming tool; and (c) removing the forming tool from said film to create said sleeve.
Claim 3
Dependent Claim
26 words
Method according to claim 1 wherein said polymeric material consists essentially of a polymer selected from the group consisting of PET, PETG, PVC, acrylic and polycarbonate.
Claim 4
Dependent Claim
31 words
Method according to claim 1 wherein said forming tool comprises elongated, tubular sidewalls and said shaped surface comprises a substantially flat end face at the distal end of said forming tool.
Claim 5
Dependent Claim
20 words
Method according to claim 3 wherein said end face is substantially normal to the longitudinal axis of said forming tool.
Claim 6
Dependent Claim
15 words
Method according to claim 1 further wherein said forming tool comprises a hollow, interior channel.
Claim 7
Dependent Claim
30 words
Method according to claim 5 additionally comprising the step of passing a fluid through said channel after cooling said sleeve in order to blow the sleeve off the forming tool.
Claim 8
Dependent Claim
19 words
Method according to claim 1 wherein said forming tool has a substantially uniform cross-sectional configuration along its longitudinal axis.
Claim 9
Dependent Claim
27 words
Method according to claim 1 wherein said forming tool comprises elongated sidewalls which taper inwardly from the proximal end of said forming tool to the distal end.
Claim 10
Dependent Claim
16 words
Method according to claim 1 wherein said forming tool comprises elongated sidewalls having substantially flat surfaces.
Claim 11
Dependent Claim
12 words
Method according to claim 1 wherein said polymeric material is optically clear.
Claim 12
Dependent Claim
14 words
Method according to claim 1 wherein said polymeric material is pigmented, tinted or coated.
Claim 13
Dependent Claim
17 words
Method according to claim 1 wherein said forming tool further comprises a flange portion projecting radially outward.
Claim 14
Dependent Claim
24 words
Method according to claim 1 further comprising the step of axially compressing at least a portion of said sleeve to form an accordion-like structure.
Claim 15
Dependent Claim
38 words
Method according to claim 1 further comprising the step of inserting said sleeve, while still mounted on said forming tool, into a second heated film of polymeric material to form a two-layer sleeve conforming to said forming tool.
Claim 16
Dependent Claim
49 words
Method according to claim 14 further comprising the steps of sequentially inserting said two-layer sleeve, while still mounted on said forming tool, into additional heated films of polymeric material to form additional sleeve layers, each said layer comprising a window portion adjacent each shaped surface of said forming tool.
Claim 17
Dependent Claim
26 words
Method according to claim 15 further comprising the step of removing all but one of said window portions adjacent each shaped surface of said forming tool.
Claim 18
Dependent Claim
32 words
Method according to claim 1 further comprising the step of fastening said open end of said sleeve to one end of a length of hollow tubing to form an elongated tubular covering.
Claim 19
Dependent Claim
27 words
Method according to claim 1 further comprising the step of placing a thin-walled tube over said forming tool prior to inserting it into said heated first film.
Claim 20
Dependent Claim
23 words
Method according to claim 3 further wherein said end face has an outer diameter greater than the outer diameter of said tubular sidewalls.
Claim 21
Dependent Claim
27 words
Method according to claim 19 further wherein said end face comprises a collapsible core or split ring structure to facilitate said step of removing the forming tool.
Claim 22
Dependent Claim
14 words
Method according to claim 1 further wherein said forming tool comprises a double-walled channel.
Claim 23
Dependent Claim
23 words
Method according to claim 21 additionally comprising the step of circulating a heat transfer fluid inside said double-walled channel during the sleeve-forming process.
Claim 24
Dependent Claim
18 words
Method according to claim 1 wherein the sidewalls of said sleeve have a thickness less than 0.010 inches.
Claim 25
Dependent Claim
18 words
Method according to claim 1 wherein the sidewalls of said sleeve have a thickness less than 0.005 inches.
Claim 26
Dependent Claim
18 words
Method according to claim 1 wherein the sidewalls of said sleeve have a thickness less than 0.003 inches.
Claim 27
Dependent Claim
20 words
Method according to claim 14 wherein said second heated film comprises a different polymeric material than said first heated film.
Claim 28
Dependent Claim
17 words
Method according to claim 15 wherein at least two of said heated films comprise different polymeric materials.
Claim 29
Dependent Claim
22 words
Method according to claim 1 wherein said polymeric material is a thermoplastic polyester selected from the group consisting of PET and PETG.
Claim 30
Dependent Claim
13 words
Method according to claim 1 wherein said polymeric material is transparent to lasers.
Claim 31
Dependent Claim
20 words
Method according to claim 4 wherein said window has an outer diameter greater than the outer diameter of said sleeve.
Claim 32
Dependent Claim
24 words
Method according to claim 4 wherein the outer diameter of said window is about 0.001-0.015 inches greater than the outer diameter of said sleeve.
Claim 33
Dependent Claim
37 words
Method according to claim 1 further comprising the step of positioning a relatively rigid, apertured disc at the distal end of said forming tool prior to the step of inserting the forming tool into said heated film.
Claim 34
Dependent Claim
25 words
Method according to claim 32 wherein at least one aperture of said disc is positioned to be in alignment with said window of said sleeve.
Claim 35
Dependent Claim
93 words
Method of forming a sheath apparatus for covering an optical medical instrument used for internal body applications comprising the steps of inserting an elongated forming tool having at least one substantially flat surface into a first malleable polymeric film so as to form an elongated polymeric sleeve conforming in shape with said forming tool and comprising an optically transparent window at each place where said film was adjacent each said substantially flat surface, cooling said sleeve below a malleable temperature, and withdrawing said forming tool from said film to create said sheath apparatus.
Claim 36
Dependent Claim
93 words
Method of forming a sheath apparatus for covering an optical medical instrument used for internal body applications comprising the steps of inserting an elongated forming tool having at least one substantially flat surface into a first malleable polymeric film so as to form an elongated polymeric sleeve conforming in shape with said forming tool and comprising an optically transparent window at each place where said film was adjacent each said substantially flat surface, cooling said sleeve below a malleable temperature, and withdrawing said forming tool from said film to create said sheath apparatus.
Claim 37
Dependent Claim
15 words
Method according to claim 1 wherein said polymeric material consists essentially of a thermoplastic polyester.
Claim 38
Dependent Claim
15 words
Method according to claim 34 wherein said polymeric film consists essentially of a thermoplastic polyester.
Claim 39
Dependent Claim
26 words
Method according to claim 34 wherein said polymeric film consists essentially of a polymer selected from the group consisting of PET, PETG, PVC, acrylic and polycarbonate.
Claim 40
Dependent Claim
27 words
Method according to claim 34 wherein said forming tool comprises elongated, tubular sidewalls and said substantially flat surface is at the distal end of said forming tool.
Claim 41
Dependent Claim
20 words
Method according to claim 38 wherein said flat surface is substantially normal to the longitudinal axis of said forming tool.
Claim 42
Dependent Claim
15 words
Method according to claim 34 further wherein said forming tool comprises a hollow, interior channel.
Claim 43
Dependent Claim
30 words
Method according to claim 40 additionally comprising the step of passing a fluid through said channel after cooling said sleeve in order to blow the sleeve off the forming tool.
Claim 44
Dependent Claim
19 words
Method according to claim 34 wherein said forming tool has a substantially uniform cross-sectional configuration along its longitudinal axis.
Claim 45
Dependent Claim
27 words
Method according to claim 34 wherein said forming tool comprises elongated sidewalls which taper inwardly from the proximal end of said forming tool to the distal end.
Claim 46
Dependent Claim
16 words
Method according to claim 34 wherein said forming tool comprises elongated sidewalls having substantially flat surfaces.
Claim 47
Dependent Claim
12 words
Method according to claim 34 wherein said polymeric film is optically clear.
Claim 48
Dependent Claim
14 words
Method according to claim 34 wherein said polymeric film is pigmented, tinted or coated.
Claim 49
Dependent Claim
17 words
Method according to claim 34 wherein said forming tool further comprises a flange portion projection radially outward.
Claim 50
Dependent Claim
24 words
Method according to claim 34 further comprising the step of axially compressing at least a portion of said sleeve to form an accordion-like structure.
Claim 51
Dependent Claim
36 words
Method according to claim 34 further comprising the step of inserting said sleeve, while still mounted on said forming tool, into a second malleable polymeric film to form a two-layer sleeve conforming to said forming tool.
Claim 52
Dependent Claim
47 words
Method according to claim 49 further comprising the steps of sequentially inserting said two-layer sleeve, while still mounted on said forming tool, into additional malleable polymeric films to form additional sleeve layers, each said layer comprising a window portion adjacent each flat surface of said forming tool.
Claim 53
Dependent Claim
26 words
Method according to claim 50 further comprising the step of removing all but one of said window portions adjacent each flat surface of said forming tool.
Claim 54
Dependent Claim
32 words
Method according to claim 34 further comprising the step of fastening an open end of said sleeve to one end of a length of hollow tubing to form an elongated tubular covering.
Claim 55
Dependent Claim
26 words
Method according to claim 34 further comprising the step of placing a thin-walled tube over said forming tool prior to inserting it into said polymeric film.
Claim 56
Dependent Claim
23 words
Method according to claim 34 further wherein said flat surface has an outer diameter greater than the outer diameter of said tubular sidewalls.
Claim 57
Dependent Claim
27 words
Method according to claim 54 further wherein said flat surface comprises a collapsible core or split ring structure to facilitate said step of withdrawing the forming tool.
Claim 58
Dependent Claim
14 words
Method according to claim 34 further wherein said forming tool comprises a double-walled channel.
Claim 59
Dependent Claim
23 words
Method according to claim 56 additionally comprising the step of circulating a heat transfer fluid inside said double-walled channel during the sleeve-forming process.
Claim 60
Dependent Claim
16 words
Method according to claim 34 wherein said sleeve has a wall thickness less than 0.010 inches.
Claim 61
Dependent Claim
16 words
Method according to claim 34 wherein said sleeve has a wall thickness less than 0.005 inches.
Claim 62
Dependent Claim
16 words
Method according to claim 34 wherein said sleeve has a wall thickness less than 0.003 inches.
Claim 63
Dependent Claim
17 words
Method according to claim 49 wherein said second film comprises a different material than said first film.
Claim 64
Dependent Claim
15 words
Method according to claim 50 wherein at least two of said films comprise different materials.
Claim 65
Dependent Claim
22 words
Method according to claim 34 wherein said polymeric film is a thermoplastic polyester selected from the group consisting of PET and PETG.
Claim 66
Dependent Claim
13 words
Method according to claim 34 wherein said polymeric film is transparent to lasers.
Claim 67
Dependent Claim
25 words
Method according to claim 39 wherein the outer diameter of said flat surface is about 0.001-0.015 inches greater than the outer diameter of said sleeve.
Claim 68
Dependent Claim
37 words
Method according to claim 34 further comprising the step of positioning a relatively rigid, apertured disc at the distal end of said forming tool prior to the step of inserting the forming tool into said malleable film.
Claim 69
Dependent Claim
25 words
Method according to claim 66 wherein at least one aperture of said disc is positioned to be in alignment with a window of said sleeve.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1998-08-21 | 1999-02-20 | 1999-08-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-08-21 | 2003-02-20 | 2003-08-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-08-21 | 2007-02-20 | 2007-08-22 | $7700.00 | Window Closed / Lapsed |