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US6210338B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Sizing catheter for measuring cardiovascular structures

Assignee: St Jude Medical Cardiology Division Inc
•
Filing: 1999-11-29
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Granted: 2001-04-03
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Expires: 2019-11-29
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Abstract

Abstract A sizing catheter and method of measuring a preselected internal opening within a patient to provide a rapid and precise determination of first and second stretched diameters of the preselected internal opening. The sizing catheter includes a dilation balloon constructed of a thin expandable plastic, which is inflatable and is utilized to determine a size of the preselected opening. The dilation balloon is inflated to an inflation threshold wherein the dilation balloon deforms about the preselected opening and the size of the dilation balloon adjacent the preselected opening approximates the first stretched diameter of the preselected opening. The sizing catheter and method may be utilized to determine an appropriate sized device to be positioned within the preselected opening.

Inventors

  • 👤 Michael Afremov
  • 👤 Kurt Amplatz

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 12:56
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/02; A61B5/103; A61B5/107; A61B5/1076; A61M; A61M25/00; A61M25/10

Claims Analysis

Total Claims: 30
Claim 1
Independent Claim 130 words
A sizing catheter for measuring the size of an internal opening or defect within a patient, said sizing catheter including: a tubular shaft having a longitudinal axis extending between a proximal end and a distal end thereof, said tubular shaft further having a lumen extending between the proximal end and a region short of the distal end and terminating into ports extending through the tubular shaft from the lumen to an outer surface of the tubular shaft, wherein an elongated compliant balloon affixed to the tubular shaft proximate the distal end of the tubular shaft encloses the ports and, when positioned within the opening and inflated, resists deformation up to an inflation threshold such that when the inflation threshold is reached fluid flow between the balloon and the opening terminates.
Claim 2
Dependent Claim 130 words
A sizing catheter for measuring the size of an internal opening or defect within a patient, said sizing catheter including: a tubular shaft having a longitudinal axis extending between a proximal end and a distal end thereof, said tubular shaft further having a lumen extending between the proximal end and a region short of the distal end and terminating into ports extending through the tubular shaft from the lumen to an outer surface of the tubular shaft, wherein an elongated compliant balloon affixed to the tubular shaft proximate the distal end of the tubular shaft encloses the ports and, when positioned within the opening and inflated, resists deformation up to an inflation threshold such that when the inflation threshold is reached fluid flow between the balloon and the opening terminates.
Claim 3
Dependent Claim 33 words
The sizing catheter as recited in claim 1 , further including a pressure sensor coupled to the proximal end of said tubular shaft, wherein said pressure sensor measures a pressure within the lumen.
Claim 4
Dependent Claim 35 words
The sizing catheter as recited in claim 2 , wherein once said inflation threshold is reached the pressure within the lumen is increased a predetermined amount to further stretch the opening by a controlled amount.
Claim 5
Dependent Claim 23 words
The sizing catheter as recited in claim 3 , wherein the predetermined amount is in the range between 25 mmHg to 100 mmHg.
Claim 6
Dependent Claim 22 words
The sizing catheter as recited in claim 1 , further including radiopaque markings affixed to the tubular shaft proximate the dilation balloon.
Claim 7
Dependent Claim 33 words
The sizing catheter as recited in claim 1 , wherein the distal end of the tubular shaft is bent at a 45 degree angle relative to the longitudinal axis of the tubular shaft.
Claim 8
Dependent Claim 19 words
The sizing catheter as recited in claim 1 , wherein the dilation balloon is constructed of an expandable polymer.
Claim 9
Dependent Claim 17 words
The sizing catheter as recited in claim 1 , wherein the dilation balloon is constructed of polyurethane.
Claim 10
Dependent Claim 29 words
The sizing catheter as recited in claim 1 , wherein the ports includes a series of ports aligned in a spiral fashion around the circumference of the tubular shaft.
Claim 11
Dependent Claim 150 words
A sizing catheter for measuring the size of an internal opening or defect within a patient, said sizing catheter including: a tubular shaft having a longitudinal axis extending between a proximal end and a distal end thereof, said tubular shaft further having a lumen extending between the proximal end and a region short of the distal end and terminating into ports extending through the tubular shaft from the lumen to an outer surface of the tubular shaft, wherein an elongated compliant balloon affixed to the tubular shaft proximate the distal end of the tubular shaft encloses the ports and, when positioned within the opening and inflated, resists deformation up to an inflation threshold such that when the inflation threshold is reached fluid flow between the balloon and the opening terminates, said proximal end of said tubular shaft having a pressure sensor coupled thereto to measure a pressure within the lumen.
Claim 12
Dependent Claim 150 words
A sizing catheter for measuring the size of an internal opening or defect within a patient, said sizing catheter including: a tubular shaft having a longitudinal axis extending between a proximal end and a distal end thereof, said tubular shaft further having a lumen extending between the proximal end and a region short of the distal end and terminating into ports extending through the tubular shaft from the lumen to an outer surface of the tubular shaft, wherein an elongated compliant balloon affixed to the tubular shaft proximate the distal end of the tubular shaft encloses the ports and, when positioned within the opening and inflated, resists deformation up to an inflation threshold such that when the inflation threshold is reached fluid flow between the balloon and the opening terminates, said proximal end of said tubular shaft having a pressure sensor coupled thereto to measure a pressure within the lumen.
Claim 13
Dependent Claim 35 words
The sizing catheter as recited in claim 10 , wherein once said inflation threshold is reached the pressure within the lumen is increased a predetermined amount to further stretch the opening by a controlled amount.
Claim 14
Dependent Claim 23 words
The sizing catheter as recited in claim 11 , wherein the predetermined amount is in the range between 25 mmHg to 100 mmHg.
Claim 15
Dependent Claim 22 words
The sizing catheter as recited in claim 10 , further including radiopaque markings affixed to the tubular shaft proximate the dilation balloon.
Claim 16
Dependent Claim 33 words
The sizing catheter as recited in claim 10 , wherein the distal end of the tubular shaft is bent at a 45 degree angle relative to the longitudinal axis of the tubular shaft.
Claim 17
Dependent Claim 19 words
The sizing catheter as recited in claim 10 , wherein the dilation balloon is constructed of an expandable polymer.
Claim 18
Dependent Claim 17 words
The sizing catheter as recited in claim 10 , wherein the dilation balloon is constructed of polyurethane.
Claim 19
Dependent Claim 29 words
The sizing catheter as recited in claim 10 , wherein the ports includes a series of ports aligned in a spiral fashion around the circumference of the tubular shaft.
Claim 20
Independent Claim 109 words
A method of determining a size of an internal opening or defect within a patient, said method including the steps of: a) providing a catheter having an elongated balloon for sizing a predetermined internal opening of a patient, said elongated balloon being constructed of a thin expandable plastic and being inflatable to thereby approximate a size of the predetermined opening; b) positioning the elongated balloon within the predetermined opening; c) viewing the internal position of the elongated balloon; and d) inflating said elongated balloon to an inflation threshold, such that the elongated balloon deforms about the predetermined opening wherein fluid ceases flowing between the elongated balloon and the opening.
Claim 21
Independent Claim 109 words
A method of determining a size of an internal opening or defect within a patient, said method including the steps of: a) providing a catheter having an elongated balloon for sizing a predetermined internal opening of a patient, said elongated balloon being constructed of a thin expandable plastic and being inflatable to thereby approximate a size of the predetermined opening; b) positioning the elongated balloon within the predetermined opening; c) viewing the internal position of the elongated balloon; and d) inflating said elongated balloon to an inflation threshold, such that the elongated balloon deforms about the predetermined opening wherein fluid ceases flowing between the elongated balloon and the opening.
Claim 22
Dependent Claim 30 words
The method as recited in claim 18 , further including the step of determining the size of the dilation balloon adjacent the predetermined opening once the inflation threshold is reached.
Claim 23
Dependent Claim 34 words
The method as recited in claim 18 , wherein the step of positioning the dilation balloon further includes positioning a longitudinal axis of the balloon relatively perpendicular to a plane of the predetermined opening.
Claim 24
Dependent Claim 43 words
The method as recited in claim 20 , wherein a distal end of said catheter includes markers and said sizing catheter is advanced through the predetermined opening such that said markers may be utilized to determine a thickness dimension of the predetermined opening.
Claim 25
Dependent Claim 39 words
The method according to claim 18 , wherein once the elongated balloon is inflated to the inflation threshold, increasing a pressure within the balloon by a predetermined amount to further stretch the predetermined opening to a second stretched diameter.
Claim 26
Dependent Claim 21 words
The method as recited in claim 22 , further including the step of determining the size of the second stretched diameter.
Claim 27
Dependent Claim 24 words
The method as recited in claim 23 , further including the step of using echocardiography to measure the size of the second stretched diameter.
Claim 28
Dependent Claim 43 words
The method as recited in claim 18 , wherein a distal end of said catheter includes markers and said sizing catheter is advanced through the predetermined opening such that said markers may be utilized to determine a thickness dimension of the predetermined opening.
Claim 29
Dependent Claim 21 words
The method as recited in claim 18 , further including using echocardiography to view the internal position of the elongated balloon.
Claim 30
Dependent Claim 23 words
The method as recited in claim 18 , wherein a diameter of the predetermined opening is measured when the inflation threshold is reached.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2004-04-02 2004-10-02 2005-04-03 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2008-04-02 2008-10-02 2009-04-03 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2012-04-02 2012-10-02 2013-04-03 $7700.00 Window Closed / Lapsed

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