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US6692462B2 Expired / Lapsed US ⏱️ 0.0 years remaining

System and method for establishing vascular access

Assignee: Covidien LP
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Filing: 2000-12-11
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Granted: 2004-02-17
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Expires: 2020-12-11
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Abstract

Abstract Systems, kits, and methods for establishing vascular access are described. A system may include a needle, a radially expandable sleeve and a dilator. The methods include creating an initial tissue tract to a target blood vessel with a radially expandable sleeve mounted on a needle. Upon removal of the needle, the dilator is then passed through the radially expandable sleeve to effect radial expansion of the sleeve. Use of the sleeve reduces the risk of injuring tissue surrounding the tissue tract by lessening the axial forces imparted to the tissue. Kits comprise at least the radially expandable sleeve together with instructions for use.

Inventors

  • 👤 Andrew J. MacKenzie
  • 👤 John E. Carlson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-25 07:24
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/34; A61B17/3415; A61B17/3417; A61B17/3421; A61B17/3439; A61M; A61M25/00; A61M25/01; A61M25/06; A61M25/0662; A61B17/3431

Claims Analysis

Total Claims: 30
Claim 1
Independent Claim 110 words
A method for establishing vascular access, said method comprising the steps of: inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; and locking said radially expandable sleeve to retain said larger diameter configuration.
Claim 2
Independent Claim 110 words
A method for establishing vascular access, said method comprising the steps of: inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; and locking said radially expandable sleeve to retain said larger diameter configuration.
Claim 3
Dependent Claim 28 words
A method as in claim 1 , wherein the step of inserting includes penetrating the needle through tissue overlying the target blood vessel to form the tissue tract.
Claim 4
Dependent Claim 27 words
A method as in claim 2 , wherein the sleeve is coaxially aligned with the needle so that insertion simultaneously positions both the needle and the sleeve.
Claim 5
Dependent Claim 16 words
A method as in claim 3 , wherein the sleeve is coaxially mounted on the needle.
Claim 6
Dependent Claim 27 words
A method as in claim 4 , wherein the sleeve has an outer diameter which is no more than 300% of the outer diameter of the needle.
Claim 7
Dependent Claim 16 words
A method as in claim 1 , wherein the radially expandable sleeve comprises a tubular braid.
Claim 8
Dependent Claim 26 words
A method as in claim 6 , wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.
Claim 9
Dependent Claim 19 words
A method as in claim 7 , wherein the braid is embedded in or covered by an elastic layer.
Claim 10
Dependent Claim 16 words
A method as in claim 1 , wherein the radially expandable sleeve comprises an anti-thrombotic coating.
Claim 11
Dependent Claim 34 words
A method as in claim 1 , wherein the needle has a nominal diameter of 0.92 mm (0.036 in.), and the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).
Claim 12
Independent Claim 150 words
A method for establishing vascular access said method comprising including the steps of: inserting an access needle and a radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel, so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract, wherein the radially expandable sleeve includes a tubular braid which has a compliant or elastic structure and wherein the large diameter of the sleeve is maintained by an outer tube of the dilator which remains in place after the dilator is removed; removing the needle from the tissue tract; introducing a dilator through the expandable sleeve to increase the diameter of the expandable sleeve to a larger diameter; removing the dilator wherein the expandable sleeve retains the larger diameter; and locking the radially expandable sleeve to retain said larger diameter.
Claim 13
Independent Claim 150 words
A method for establishing vascular access said method comprising including the steps of: inserting an access needle and a radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel, so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract, wherein the radially expandable sleeve includes a tubular braid which has a compliant or elastic structure and wherein the large diameter of the sleeve is maintained by an outer tube of the dilator which remains in place after the dilator is removed; removing the needle from the tissue tract; introducing a dilator through the expandable sleeve to increase the diameter of the expandable sleeve to a larger diameter; removing the dilator wherein the expandable sleeve retains the larger diameter; and locking the radially expandable sleeve to retain said larger diameter.
Claim 14
Dependent Claim 28 words
A method as in claim 11 , wherein the step of inserting includes penetrating the needle through tissue overlying the target blood vessel to form the tissue tract.
Claim 15
Dependent Claim 27 words
A method as in claim 12 , wherein the sleeve is coaxially aligned with the needle so that insertion simultaneously positions both the needle and the sleeve.
Claim 16
Dependent Claim 26 words
A method as in claim 13 , wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.
Claim 17
Dependent Claim 19 words
A method as in claim 14 , wherein the braid is embedded in or covered by an elastic layer.
Claim 18
Dependent Claim 16 words
A method as in claim 11 , wherein the radially expandable sleeve comprises an anti-thrombotic coating.
Claim 19
Dependent Claim 22 words
A method as in claim 11 , wherein the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).
Claim 20
Dependent Claim 23 words
A method as in claim 17 , wherein the dilator has an outside diameter in the range from 1.3 mm to 3.3 mm.
Claim 21
Dependent Claim 22 words
A method as in claim 11 , wherein the sleeve has a lumen diameter prior to expansion of 0.41 mm (0.016 in.).
Claim 22
Dependent Claim 23 words
A method as in claim 19 , wherein the dilator has an outside diameter in the range from 1 mm to 2.5 mm.
Claim 23
Independent Claim 119 words
A method for establishing vascular access, said method comprising the steps of: inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure includes a valve disposed within said access lumen of said expandable sleeve; locking said radially expandable sleeve to retain said larger diameter configuration.
Claim 24
Independent Claim 119 words
A method for establishing vascular access, said method comprising the steps of: inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure includes a valve disposed within said access lumen of said expandable sleeve; locking said radially expandable sleeve to retain said larger diameter configuration.
Claim 25
Dependent Claim 23 words
The method as in claim 21 , wherein said valve of said providing step is a hemostasis valve disposed within said access lumen.
Claim 26
Dependent Claim 18 words
The method as in claim 21 , wherein said valve of said providing step is a duckbill valve.
Claim 27
Dependent Claim 18 words
The method as in claim 21 , wherein said valve of said providing step is a miter valve.
Claim 28
Dependent Claim 34 words
The method as in claim 21 , further including the steps of: inserting a device through the valve; and maintaining the valve in an open position when the device is inserted through the valve.
Claim 29
Independent Claim 105 words
A method for establishing vascular access, said method comprising the steps of: positioning an access needle and a radially expandable sleeve through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; and providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure including a valve disposed within said access lumen of said expandable sleeve.
Claim 30
Independent Claim 105 words
A method for establishing vascular access, said method comprising the steps of: positioning an access needle and a radially expandable sleeve through a percutaneous tissue tract leading to a target blood vessel so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; expanding the expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; and providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure including a valve disposed within said access lumen of said expandable sleeve.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2007-02-16 2007-08-18 2008-02-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2011-02-16 2011-08-18 2012-02-17 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2015-02-16 2015-08-18 2016-02-17 $7700.00 Window Closed / Lapsed

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