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US6475226B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Percutaneous bypass apparatus and method

Assignee: Boston Scientific Scimed Inc
•
Filing: 1999-02-03
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Granted: 2002-11-05
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Expires: 2019-02-03
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Abstract

Abstract Devices and methods for percutaneous translumenal minimally invasive coronary surgery, particularly bypass surgery involving the following basic steps: determining a proper location for treatment, navigating a suitable device to the treatment site, creating an extravascular opening and pathway, guiding and/or monitoring the progress of creating the opening and pathway, and maintaining the extravascular opening and pathway. One or more extravascular openings and/or pathways may be created to define a fluid path or bypass around the vascular restriction. For example, an intravascular catheter for creating an extravascular opening in a vessel wall includes an elongate shaft adapted for intravascular navigation, an anchoring mechanism disposed on the distal end of the shaft, and a tissue penetrating member having a proximal end slidably disposed in the shaft and a distal end including a tissue penetrating mechanism.

Inventors

  • 👤 William M. Belef
  • 👤 Eric M. DoBrava
  • 👤 Joseph D. Farrell
  • 👤 Jaydeep Y. Kokate
  • 👤 Daniel M. Lafontaine
  • 👤 Brian J. Lowe
  • 👤 Jonathan C. Sell
  • 👤 Bradley F. Slaker
  • 👤 David A. White

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 06:28
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/00234; A61B1/00; A61B1/313; A61B1/3137; A61B17/11; A61B18/00; A61B18/04; A61B18/12; A61B18/14; A61B18/1492; A61B17/34; A61B17/3403; A61B18/18; A61B18/20; A61B18/22; A61B18/24; A61B2017/00017; A61B2017/00022; A61B2017/00057; A61B2017/00066; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2017/00252; A61B2017/1107; A61B2017/1139; A61B2018/00053; A61B2018/00214; A61B2018/0022; A61B2018/00273; A61B2018/00279; A61B2018/00285; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00386; A61B2018/00571; A61B2018/00595; A61B90/00; A61B90/06; A61B2090/062; A61M; A61M25/00; A61M25/0043; A61M2025/0063; A61M25/10; A61M25/104

Claims Analysis

Total Claims: 41
Claim 1
Independent Claim 164 words
An intravascular catheter for creating an extravascular opening in a vessel wall, comprising: an elongate shaft having a proximal end and a distal end, the shaft adapted for intravascular navigation; an anchoring mechanism disposed on the distal end of the shaft, the anchoring mechanism having a delivery position and an anchor position; a tissue penetrating member having a proximal end and a distal end, the proximal end of the penetrating member slidably disposed in the shaft and the distal end of the tissue penetrating member having a tissue penetrating mechanism, wherein the tissue penetrating member is extendable between a retracted position and a penetrating position, the tissue penetrating mechanism extending completely through the vessel wall when in the penetrating position to establish the extravascular opening therethrough and the tissue penetrating member including a flexible normally curved tip; and a relatively stiff tubular member slidably disposed relative to the tissue penetrating member to adjust flexure of the flexible normally curved tip of the penetrating member.
Claim 2
Dependent Claim 164 words
An intravascular catheter for creating an extravascular opening in a vessel wall, comprising: an elongate shaft having a proximal end and a distal end, the shaft adapted for intravascular navigation; an anchoring mechanism disposed on the distal end of the shaft, the anchoring mechanism having a delivery position and an anchor position; a tissue penetrating member having a proximal end and a distal end, the proximal end of the penetrating member slidably disposed in the shaft and the distal end of the tissue penetrating member having a tissue penetrating mechanism, wherein the tissue penetrating member is extendable between a retracted position and a penetrating position, the tissue penetrating mechanism extending completely through the vessel wall when in the penetrating position to establish the extravascular opening therethrough and the tissue penetrating member including a flexible normally curved tip; and a relatively stiff tubular member slidably disposed relative to the tissue penetrating member to adjust flexure of the flexible normally curved tip of the penetrating member.
Claim 3
Dependent Claim 36 words
An intravascular catheter as in claim 1 further comprising: a stiffening member disposed about the tissue penetrating member between the relatively stiff tubular member to provide rigidity to a distal portion of the tissue penetrating member.
Claim 4
Dependent Claim 16 words
An intravascular catheter as in claim 1 , wherein the anchoring mechanism comprises an inflatable balloon.
Claim 5
Dependent Claim 31 words
An intravascular catheter as in claim 3 , further comprising an outer tube in which the tissue penetrating member is disposed and through which the relatively stiff tubular member slidably extends.
Claim 6
Dependent Claim 31 words
An intravascular catheter as in claim 4 , wherein the outer tube terminates adjacent a distal cone of the balloon between a proximal end and a distal end of the balloon.
Claim 7
Dependent Claim 31 words
An intravascular catheter as in claim 4 , wherein the outer tube terminates adjacent a proximal cone of the balloon between a proximal end and a distal end of the balloon.
Claim 8
Dependent Claim 31 words
An intravascular catheter as in claim 4 , wherein the outer tube terminates adjacent a body portion of the balloon between a proximal end and a distal end of the balloon.
Claim 9
Dependent Claim 19 words
An intravascular catheter as in claim 4 , wherein the outer tube exits a distal end of the balloon.
Claim 10
Dependent Claim 28 words
An intravascular catheter as in claim 4 wherein the balloon is separated into a proximal balloon and a distal balloon and wherein the outer tube terminates between balloons.
Claim 11
Dependent Claim 30 words
An intravascular catheter as in claim 4 wherein the balloon comprises a helical type balloon and wherein the outer tube terminates at a mid portion of the helical type balloon.
Claim 12
Dependent Claim 29 words
An intravascular catheter as in claim 2 , wherein the distal end of the tissue penetrating member is at an angle relative the shaft when in the penetrating position.
Claim 13
Dependent Claim 15 words
An intravascular catheter as in claim 5 , wherein the angle is up to 90°.
Claim 14
Dependent Claim 87 words
An intravascular catheter as in claim 1 , wherein the anchoring mechanism comprises an inflatable balloon and the tissue penetrating member extends through a lumen along the elongate shaft and the lumen includes a portion extending along a length of the inflatable balloon to a distal lumen opening between a proximal end and a distal end of the inflatable balloon and the tissue penetrating member is slidably extendable through the distal lumen opening so that the distal end of the tissue penetrating member exits the anchoring mechanism.
Claim 15
Dependent Claim 30 words
An intravascular catheter as in claim 1 , further comprising a stiffening member slideable relative to the shaft and the relatively stiff tubular member is disposed about the stiffening member.
Claim 16
Independent Claim 107 words
A method of bypassing a restriction in a vessel, comprising the steps of: providing an intravascular catheter having a tissue penetrating member disposed therein, a proximal end of the penetrating member slidably disposed in the catheter and a distal end of the tissue penetrating member having an adjustable tip portion having an adjustable orientation and the adjustable tip portion including a tissue penetrating mechanism; navigating a distal end of the catheter to a position adjacent the restriction; remotely adjusting the orientation of the adjustable tip portion of the tissue penetrating member; and slidably advancing the tissue penetrating member relative to the catheter to form an extravascular passageway.
Claim 17
Independent Claim 107 words
A method of bypassing a restriction in a vessel, comprising the steps of: providing an intravascular catheter having a tissue penetrating member disposed therein, a proximal end of the penetrating member slidably disposed in the catheter and a distal end of the tissue penetrating member having an adjustable tip portion having an adjustable orientation and the adjustable tip portion including a tissue penetrating mechanism; navigating a distal end of the catheter to a position adjacent the restriction; remotely adjusting the orientation of the adjustable tip portion of the tissue penetrating member; and slidably advancing the tissue penetrating member relative to the catheter to form an extravascular passageway.
Claim 18
Dependent Claim 50 words
A method of bypassing a restriction in a vessel as in claim 15 , wherein the catheter includes an anchor mechanism, further comprising the steps of: prior to advancing the tissue penetrating member, actuating the anchor mechanism such that the anchor mechanism is anchored adjacent the restriction in the vessel.
Claim 19
Dependent Claim 37 words
A method of bypassing a restriction in a vessel as in claim 16 , wherein the anchor mechanism comprises a balloon, and wherein the step of actuating the anchor mechanism comprises the step of inflating the balloon.
Claim 20
Dependent Claim 51 words
A method of bypassing a restriction in a vessel as in claim 15 , further comprising the steps of: emitting light from the distal end of the penetrating member; and detecting light reflected by tissue adjacent the distal end of the penetrating member to monitor advancement of the tissue penetrating member.
Claim 21
Dependent Claim 51 words
A method of bypassing a restriction in a vessel as in claim 15 , further comprising the steps of: emitting ultrasound from the distal end of the penetrating member; and detecting ultrasound reflected by tissue adjacent the distal end of the penetrating member to monitor advancement of the tissue penetrating member.
Claim 22
Dependent Claim 56 words
A method of bypassing a restriction in a vessel as in claim 15 , further comprising the steps of: emitting light from the distal end of the penetrating member; and detecting light emitted from the distal end of the penetrating member in a lumen of an adjacent vessel to monitor advancement of the tissue penetrating member.
Claim 23
Dependent Claim 56 words
A method of bypassing a restriction in a vessel as in claim 15 , further comprising the steps of: emitting ultrasound from the distal end of the penetrating member; and detecting ultrasound emitted from the distal end of the penetrating member in a lumen of an adjacent vessel to monitor advancement of the tissue penetrating member.
Claim 24
Dependent Claim 56 words
A method of bypassing a restriction in a vessel as in claim 15 , wherein the tissue penetrating mechanism creates an opening in a wall of the vessel, further comprising the steps of: providing a thermal energy emitter for heat fusing the opening; navigating the thermal energy emitter to the opening; and heat fusing the opening.
Claim 25
Dependent Claim 50 words
A method of bypassing a restriction in a vessel as in claim 22 , wherein the thermal energy emitter comprises a heatable balloon, further comprising the steps of: inflating the heatable balloon in the opening; activating the heatable balloon so as to heat the opening; and deflating the heatable balloon.
Claim 26
Dependent Claim 69 words
A method of bypassing a restriction in a vessel as in claim 15 comprising the steps of: emitting light from a bypass position in a first vessel to illuminate a bypass site proximate to the restriction; and detecting light illuminated from the first vessel in a second vessel by a sensor proximate to the distal end of the penetrating member to monitor a position of the tissue penetrating member.
Claim 27
Independent Claim 112 words
A method of bypassing a restriction comprising the steps of: providing an intravascular catheter including a tissue penetrating member slideably disposed in the catheter and including a tissue penetrating mechanism at a distal tip of the tissue penetrating member; navigating the catheter through a vessel proximate to a restriction to form an extravascular passageway between body vessels; slidably advancing the tissue penetrating member relative to the intravascular catheter to form the extravascular passageway and injecting radiopaque contrast media through a lumen of the penetrating member; and observing the penetrating member and the contrast media under fluoroscopy to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.
Claim 28
Independent Claim 112 words
A method of bypassing a restriction comprising the steps of: providing an intravascular catheter including a tissue penetrating member slideably disposed in the catheter and including a tissue penetrating mechanism at a distal tip of the tissue penetrating member; navigating the catheter through a vessel proximate to a restriction to form an extravascular passageway between body vessels; slidably advancing the tissue penetrating member relative to the intravascular catheter to form the extravascular passageway and injecting radiopaque contrast media through a lumen of the penetrating member; and observing the penetrating member and the contrast media under fluoroscopy to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.
Claim 29
Independent Claim 106 words
A method of bypassing a restriction comprising the steps of: providing an intravascular catheter including a tissue penetrating member slideably disposed relative to the intravascular catheter and including a tissue penetrating mechanism proximate to a distal end of the penetrating member; navigating the catheter through a vessel proximate to the restriction and slidably advancing the tissue penetrating member to form an extravascular passageway between body vessels; measuring pressure at the distal end of the penetrating member; and observing the pressure as the penetrating member penetrates a wall of the vessel to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.
Claim 30
Independent Claim 106 words
A method of bypassing a restriction comprising the steps of: providing an intravascular catheter including a tissue penetrating member slideably disposed relative to the intravascular catheter and including a tissue penetrating mechanism proximate to a distal end of the penetrating member; navigating the catheter through a vessel proximate to the restriction and slidably advancing the tissue penetrating member to form an extravascular passageway between body vessels; measuring pressure at the distal end of the penetrating member; and observing the pressure as the penetrating member penetrates a wall of the vessel to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.
Claim 31
Dependent Claim 123 words
An intravascular device comprising: an elongated shaft having a proximal end and a distal end and having a first inflation lumen extending therethrough; an inflatable balloon having a proximal end and a distal end and an inflatable portion open to the inflation lumen; a second lumen having a proximal end and a distal end and extending along a length of the elongated shaft and along a length portion of the inflatable balloon and having a distal opening between the proximal and distal ends of the inflatable balloon; and a tissue penetrating member having a tissue penetrating mechanism slidably disposed through the second lumen and having a tip portion extending through the distal opening between the proximal and distal ends of the inflatable balloon.
Claim 32
Dependent Claim 123 words
An intravascular device comprising: an elongated shaft having a proximal end and a distal end and having a first inflation lumen extending therethrough; an inflatable balloon having a proximal end and a distal end and an inflatable portion open to the inflation lumen; a second lumen having a proximal end and a distal end and extending along a length of the elongated shaft and along a length portion of the inflatable balloon and having a distal opening between the proximal and distal ends of the inflatable balloon; and a tissue penetrating member having a tissue penetrating mechanism slidably disposed through the second lumen and having a tip portion extending through the distal opening between the proximal and distal ends of the inflatable balloon.
Claim 33
Dependent Claim 30 words
The intravascular catheter of claim 27 wherein the balloon is an eccentric balloon and the second lumen is formed by a separate channel along the length portion of the balloon.
Claim 34
Dependent Claim 32 words
The intravascular catheter of claim 28 herein the second lumen is formed through a tube extending along the length of the elongated shaft and along the length portion of the inflatable balloon.
Claim 35
Dependent Claim 67 words
The intravascular catheter of claim 27 wherein the balloon is a helical balloon supported by a balloon sheath and the second lumen is formed through a tube extending along the length of the elongated shaft and along a portion of the balloon sheath and the tube having a distal opening forming the distal opening of the second lumen between the proximal and distal ends of the balloon.
Claim 36
Dependent Claim 120 words
An intravascular catheter comprising: an elongated shaft having a proximal end and a distal end and an elongated length therebetween; a tissue penetrating member having a proximal end and a distal end and slidably coupled to the elongated shaft to move between a first position and a second extended position and the tissue penetrating member including a tissue penetrating mechanism and an adjustable distal tip portion having an adjustable orientation; and a distal tip actuator including a distal portion operably coupled to the distal tip portion of the tissue penetrating member and an external control portion remote from the distal tip portion and operable to adjust the distal tip portion of the tissue penetrating member in a plurality of orientations.
Claim 37
Dependent Claim 120 words
An intravascular catheter comprising: an elongated shaft having a proximal end and a distal end and an elongated length therebetween; a tissue penetrating member having a proximal end and a distal end and slidably coupled to the elongated shaft to move between a first position and a second extended position and the tissue penetrating member including a tissue penetrating mechanism and an adjustable distal tip portion having an adjustable orientation; and a distal tip actuator including a distal portion operably coupled to the distal tip portion of the tissue penetrating member and an external control portion remote from the distal tip portion and operable to adjust the distal tip portion of the tissue penetrating member in a plurality of orientations.
Claim 38
Dependent Claim 67 words
The intravascular catheter of claim 31 wherein the distal tip actuator includes an elongated wire extending along the elongated length of the elongated shaft and the wire having a distal portion coupled to the distal tip portion of the tissue penetrating member and a proximal portion remote from the distal portion to adjust the distal tip portion of the tissue penetrating member in the plurality of orientations.
Claim 39
Dependent Claim 50 words
The intravascular catheter of claim 32 wherein the wire is coupled to a tubular member having an bendable tip segment disposed about the tissue penetrating member and the wire is coupled to the bendable tip segment to adjust the orientation of the distal tip portion of the tissue penetrating member.
Claim 40
Dependent Claim 29 words
The intravascular catheter of claim 33 and further comprising a stiffener member slidably disposed relative to the shaft and positioned between the tissue penetrating member and the tubular member.
Claim 41
Dependent Claim 20 words
The intravascular catheter of claim 33 wherein the wire is coupled to the bendable tip segment through a tubular collar.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2005-11-04 2006-05-06 2006-11-05 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2009-11-04 2010-05-06 2010-11-05 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2013-11-04 2014-05-06 2014-11-05 $7700.00 Window Closed / Lapsed

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