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US5484425A Expired / Lapsed US ⏱️ 0.0 years remaining

Radiopaque non-kinking thin-walled introducer sheath

Assignee: Cathco Inc
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Filing: 1994-10-12
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Granted: 1996-01-16
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Expires: 2014-10-12
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Abstract

Abstract This invention provides a non-kinking and thin-walled introducer sheath (10) having a flat wire metal coil (12) that lies within a plastic covering (20) fitted onto the exterior surface of the flat wire metal coil (12) and extends into a space between adjacent turns of the flat wire metal coil (12) without covering the interior surface. Each turn of the flat wire metal coil (12) has a thickness within the range between 0.75-3.0 mils with a width to thickness ratio lying between 12 and 80. A plastic adapter (30) is provided and is located at a proximal end of the sheath (10) for inserting guide wires through the sheath (10) into a vessel.

Inventors

  • 👤 Robert E. Fischell
  • 👤 Tim A. Fischell

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 21:00
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/06; A61M25/0662; A61M25/0043; A61M25/005; A61M25/0054; A61M25/0067; A61M25/008; A61M2025/0081; A61M25/0053

Claims Analysis

Total Claims: 56
Claim 1
Independent Claim 202 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation defining a space between adjacent turns of the flat wire metal coil, the interior surface of said flat wire metal coil forming an interior lumen of the sheath; (b) a plastic covering that is fitted onto and is in contact with the exterior surface of said flat wire metal coil, said plastic covering extending into the space between each of said adjacent turns of the flat wire metal coil without covering the interior surface of the flat wire metal coil whereby said separation between all of said adjacent turns of said flat metal coil is maintained when said introducer sheath is bent, each of said turns of said flat wire metal coil having a predetermined thickness within the approximate range of 0.75 to 3.0 mils with a predetermined width to thickness ratio between 12 and 80; and, (c) a plastic adapter including a hemostasis valve located at the proximal end of the sheath for inserting guide wires and/or catheters through the sheath and into a vessel of the human body.
Claim 2
Dependent Claim 202 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation defining a space between adjacent turns of the flat wire metal coil, the interior surface of said flat wire metal coil forming an interior lumen of the sheath; (b) a plastic covering that is fitted onto and is in contact with the exterior surface of said flat wire metal coil, said plastic covering extending into the space between each of said adjacent turns of the flat wire metal coil without covering the interior surface of the flat wire metal coil whereby said separation between all of said adjacent turns of said flat metal coil is maintained when said introducer sheath is bent, each of said turns of said flat wire metal coil having a predetermined thickness within the approximate range of 0.75 to 3.0 mils with a predetermined width to thickness ratio between 12 and 80; and, (c) a plastic adapter including a hemostasis valve located at the proximal end of the sheath for inserting guide wires and/or catheters through the sheath and into a vessel of the human body.
Claim 3
Dependent Claim 16 words
The sheath of claim 1 wherein the flat wire metal coil is made from stainless steel.
Claim 4
Dependent Claim 19 words
The sheath of claim 2 wherein the flat wire metal coil is made from a 300 series stainless steel.
Claim 5
Dependent Claim 18 words
The sheath of claim 2 wherein the flat wire metal coil is made from 400 series stainless steel.
Claim 6
Dependent Claim 30 words
The sheath of claim 1 wherein the flat wire metal coil has a space between adjacent turns that is less than the width of a single turn of the coil.
Claim 7
Dependent Claim 30 words
The sheath of claim 1 wherein the flat wire metal coil has a space between adjacent turns that is larger than the width of a single turn of the coil.
Claim 8
Dependent Claim 22 words
The sheath of claim 1 wherein the space between adjacent turns of said flat wire metal coil is less than 5.0 mm.
Claim 9
Dependent Claim 14 words
The sheath of claim 1 wherein the space between said adjacent turns is fixed.
Claim 10
Dependent Claim 14 words
The sheath of claim 1 wherein the space between said adjacent turns is variable.
Claim 11
Dependent Claim 37 words
The sheath of claim 9 wherein the space between said adjacent turns is greater at the sheath's distal end as compared to a more proximal portion of the sheath so that the sheath's tip is more flexible.
Claim 12
Dependent Claim 24 words
The sheath of claim 9 wherein the sheath has a more flexible proximal section where it passes through the skin and into an artery.
Claim 13
Dependent Claim 22 words
The sheath of claim 1 wherein the flat wire metal coil is plated with a dense metal such as gold or tantalum.
Claim 14
Dependent Claim 16 words
The sheath of claim 1 wherein the flat wire metal coil has an interior lubricious coating.
Claim 15
Dependent Claim 53 words
The sheath of claim 1 wherein said adjacent turns are touching at a radial dimension which is less than the radial dimension to the exterior surface of the flat wire metal coil and wherein there is some space between said adjacent turns that allows some outer plastic covering to extend into said space.
Claim 16
Dependent Claim 20 words
The sheath of claim 1 wherein the sheath is formed by heat shrinking the plastic covering over the metal coil.
Claim 17
Dependent Claim 39 words
The sheath of claim 1 wherein the sheath is formed by first dilating the plastic covering with a solvent and then allowing the evaporation of the solvent to cause the covering to shrink around the flat wire metal coil.
Claim 18
Dependent Claim 12 words
The sheath of claim 1 wherein the plastic covering is an elastomer.
Claim 19
Dependent Claim 12 words
The sheath of claim 17 wherein the plastic covering is a polyethylene.
Claim 20
Dependent Claim 12 words
The sheath of claim 17 wherein the plastic covering is a polyurethane.
Claim 21
Dependent Claim 11 words
The sheath of claim 17 wherein the plastic covering is polyvinylchloride.
Claim 22
Dependent Claim 11 words
The sheath of claim 17 wherein the plastic covering is Teflon.
Claim 23
Dependent Claim 17 words
The sheath of claim 1 wherein the thickness of the plastic covering is less than 0.005 inches.
Claim 24
Dependent Claim 25 words
The sheath of claim 1 wherein the plastic covering is centerless ground on its exterior surface to provide a smoother finish on that exterior surface.
Claim 25
Dependent Claim 19 words
The sheath of claim 1 wherein the sheath is formed by overextruding plastic over the flat wire metal coil.
Claim 26
Dependent Claim 34 words
The sheath of claim 24 wherein the sheath is formed by overextruding plastic over the flat wire metal coil, a central mandrel having been inserted into said coil prior to the overextrusion of plastic.
Claim 27
Dependent Claim 27 words
The sheath of claim 1 wherein the sheath is formed by coating the plastic covering over the metal coil by dipping the coil into a liquid material.
Claim 28
Dependent Claim 24 words
The sheath of claim 1 wherein the flat wire metal coil is formed from a flat wire whose cross section has squared off ends.
Claim 29
Dependent Claim 23 words
The sheath of claim 1 wherein the flat wire metal coil is formed from flat wire whose cross section has all corners rounded.
Claim 30
Dependent Claim 24 words
The sheath of claim 1 wherein the flat wire metal coil is formed from a flat wire whose cross section has all corners chamfered.
Claim 31
Dependent Claim 26 words
The sheath of claim 1 wherein the flat wire metal coil is formed from flat wire having only the interior corners of its cross section rounded.
Claim 32
Dependent Claim 26 words
The sheath of claim 1 wherein the flat wire metal coil is formed from flat wire having only the interior corners of its cross section chamfered.
Claim 33
Dependent Claim 22 words
The sheath of claim 1 wherein the outer surface of the flat wire metal coil does not adhere to the plastic covering.
Claim 34
Dependent Claim 45 words
The sheath of claim 1 wherein the plastic covering has an extension which projects into the space between said adjacent turns but does not completely fill that space which space is bounded on its interior by the inside diameter of the flat wire metal coil.
Claim 35
Dependent Claim 51 words
The sheath of claim 1 wherein the plastic covering has an extension which projects into and completely fills the space between adjacent turns of the flat wire metal coil so that the inside diameter of the plastic extension is essentially equal to the inside diameter of the flat wire metal coil.
Claim 36
Dependent Claim 59 words
The sheath of claim 1 wherein the plastic covering has an extension which projects into the space between said adjacent turns of the flat wire metal coil with the inside diameter of the extension being smaller than the inside diameter of said flat wire metal coil without any plastic covering the interior surface of the flat wire metal coil.
Claim 37
Dependent Claim 18 words
The sheath of claim 1 wherein the plastic covering has a lubricity coating applied to its outer surface.
Claim 38
Dependent Claim 21 words
The sheath of claim 1 wherein the inner surface of the plastic extension between adjacent turns has a lubricity coating applied.
Claim 39
Dependent Claim 16 words
The sheath of claim 1 wherein a metal tip is placed at the sheath's distal end.
Claim 40
Dependent Claim 17 words
The sheath of claim 38 wherein the metal tip is made from a high density, radiopaque metal.
Claim 41
Dependent Claim 22 words
The sheath of claim 39 wherein the tip is formed from a dense metal at least some of said metal being tantalum.
Claim 42
Dependent Claim 23 words
The sheath of claim 39 wherein the tip is formed from a dense metal at least some of which said metal being gold.
Claim 43
Dependent Claim 26 words
The sheath of claim 1 wherein a metal insert is placed near the sheath's distal end with a plastic covering extending distally beyond the metal insert.
Claim 44
Dependent Claim 31 words
The sheath of claim 1 wherein the sheath includes a metal tip at its distal end whose inside diameter is less than the inside diameter of the flat wire metal coil.
Claim 45
Dependent Claim 31 words
The sheath of claim 1 wherein the sheath includes a metal insert near its distal end whose inside diameter is less than the inside diameter of the flat wire metal coil.
Claim 46
Dependent Claim 27 words
The sheath of claim 1 wherein the sheath includes a plastic tip whose inside diameter is less than the inside diameter of the flat wire metal coil.
Claim 47
Dependent Claim 21 words
The sheath of claim 1 wherein the sheath includes a side port in the plastic adapter near the sheath's proximal end.
Claim 48
Dependent Claim 40 words
The sheath of claim 1 wherein the distal tip of the plastic covering extends beyond the distal end of the flat wire metal coil and is heat molded to an appropriate shape which can readily pass through the arterial wall.
Claim 49
Dependent Claim 27 words
The sheath of claim 1 wherein an interior plastic tube having a thickness of less than 0.004 inches is inserted interior to the flat wire metal coil.
Claim 50
Dependent Claim 14 words
The sheath of claim 48 wherein the interior plastic tube is made from Teflon.
Claim 51
Dependent Claim 19 words
The sheath of claim 48 wherein the interior plastic tube has a lubricity coating applied to its interior surface.
Claim 52
Dependent Claim 17 words
The sheath of claim 1 wherein the anti-bacterial coating is applied to the sheath's outer plastic covering.
Claim 53
Dependent Claim 194 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation between adjacent turns of the flat wire metal coil, each of said turns of said flat wire metal coil having a predetermined thickness within the approximate range of 0.075 to 3.0 mils with a predetermined width to thickness ratio between 12 and 20; (b) a plastic covering that is fitted onto and is in contact with the exterior surface of said flat wire metal coil, said plastic covering extending into the space between said adjacent turns of the flat wire metal coil without covering the interior surface of the flat wire metal coil; (c) an inner plastic tubular member having a through passage forming an interior lumen of said sheath, said inner plastic tubular member being positionally located contiguous an interior surface of said flat wire metal coil; and, (d) a plastic adapter including a hemostasis valve located at the proximal end of said sheath for inserting guide wires and/or catheters through said sheath and into a vessel of the human body.
Claim 54
Dependent Claim 194 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation between adjacent turns of the flat wire metal coil, each of said turns of said flat wire metal coil having a predetermined thickness within the approximate range of 0.075 to 3.0 mils with a predetermined width to thickness ratio between 12 and 20; (b) a plastic covering that is fitted onto and is in contact with the exterior surface of said flat wire metal coil, said plastic covering extending into the space between said adjacent turns of the flat wire metal coil without covering the interior surface of the flat wire metal coil; (c) an inner plastic tubular member having a through passage forming an interior lumen of said sheath, said inner plastic tubular member being positionally located contiguous an interior surface of said flat wire metal coil; and, (d) a plastic adapter including a hemostasis valve located at the proximal end of said sheath for inserting guide wires and/or catheters through said sheath and into a vessel of the human body.
Claim 55
Dependent Claim 158 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation defining interstices between adjacent turns of the flat wire metal coil, the interior surface of said flat wire metal coil forming an interior lumen of the sheath; (b) a plastic covering fitted onto and in contact with the exterior surface of said flat wire metal coil; (c) an inner plastic tubular member having a through passage forming an interior lumen of said sheath, said inner plastic tubular member being positionally located contiguous an interior surface of said flat wire metal coil; (d) a plurality of plastic insert members inserted within said interstices; and, (e) a plastic adapter including a hemostasis valve located at the proximal end of the sheath for inserting guide wires and/or catheters through the sheath and into a vessel of the human body.
Claim 56
Dependent Claim 158 words
An introducer sheath for percutaneous insertion into a vessel of a human body comprising: (a) a flat wire metal coil having a distal end and a proximal end and having some separation defining interstices between adjacent turns of the flat wire metal coil, the interior surface of said flat wire metal coil forming an interior lumen of the sheath; (b) a plastic covering fitted onto and in contact with the exterior surface of said flat wire metal coil; (c) an inner plastic tubular member having a through passage forming an interior lumen of said sheath, said inner plastic tubular member being positionally located contiguous an interior surface of said flat wire metal coil; (d) a plurality of plastic insert members inserted within said interstices; and, (e) a plastic adapter including a hemostasis valve located at the proximal end of the sheath for inserting guide wires and/or catheters through the sheath and into a vessel of the human body.

References Cited (Backward Citations)

US4044765A Cited
US4705511A Cited
US4676229A Cited
US4917666A Cited
US4955862A Cited
US5180376A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1999-01-15 1999-07-17 2000-01-16 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2003-01-15 2003-07-17 2004-01-16 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2007-01-15 2007-07-17 2008-01-16 $7700.00 Window Closed / Lapsed

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