US2005267520A1PendingUtilityA1

Access and closure device and method

47
Individually held — no corporate assignee on recordPriority: May 12, 2004Filed: May 12, 2004Published: Dec 1, 2005
Est. expiryMay 12, 2024(expired)· nominal 20-yr term from priority
Inventors:D. Bruce Modesitt
A61B 17/0057A61B 2017/00659A61M 25/04A61B 17/0469A61B 2017/00637A61B 2017/0406A61B 2017/0496A61B 2017/0403A61B 2017/0419A61B 2017/3405A61B 17/1285A61B 17/068A61B 2017/00672A61B 17/0644A61B 2017/0417A61M 2025/0002A61M 25/01A61B 17/12009A61B 17/3403A61M 25/06A61B 17/0401A61B 2017/00676A61B 2017/06052A61B 17/3415
47
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Claims

Abstract

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Claims

exact text as granted — not AI-modified
1 . A device for accessing a biological lumen having a lumen wall having a longitudinal lumen wall axis, the device comprising: 
 an elongated member comprising a longitudinal member axis, wherein the member is configured to access the lumen at a first angle, and wherein the first angle is defined by the longitudinal lumen wall axis and the longitudinal member axis, wherein the first angle is less than about 19 degrees.    
   
   
       2 . The device of  claim 1 , wherein the first angle is less than about 15 degrees.  
   
   
       3 . The device of  claim 2 , wherein the first angle is less than about 10 degrees.  
   
   
       4 . The device of  claim 3 , wherein the first angle is greater than about 5 degrees.  
   
   
       5 . The device of  claim 1 , further comprising an anchor.  
   
   
       6 . The device of  claim 5 , wherein the anchor is configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen wall axis.  
   
   
       7 . The device of  claim 1 , further comprising a retainer.  
   
   
       8 . The device of  claim 7 , wherein the retainer is configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen axis.  
   
   
       9 . A device for accessing a biological lumen having a lumen wall and a longitudinal lumen wall axis, the device comprising: 
 a first elongated member comprising a first elongated member axis, and    a second elongated member comprising a second elongated member axis,    wherein the second elongated member is configured so that the second elongated member axis is parallel to the longitudinal lumen wall axis.    
   
   
       10 . The device of  claim 9 , wherein the second elongated member comprises a retainer.  
   
   
       11 . The device of  claim 10 , wherein the retainer comprises an inflatable member.  
   
   
       12 . The device of  claim 10 , wherein the retainer comprises a resilient member.  
   
   
       13 . The device of  claim 9 , wherein the second elongated member extends substantially adjacent to the lumen wall.  
   
   
       14 . A device for closing an opening on a biological lumen wall, comprising: 
 a longitudinal axis,    a first force-applying member,    a second force-applying member, and    a resilient member,    wherein the resilient member provides to the first and the second force-applying members an outward radial force with respect to the longitudinal axis.    
   
   
       15 . The device of  claim 14 , wherein the first force-applying member applies force in a first direction, and wherein the second force-applying member applies force in a second direction, and wherein the first direction is substantially opposite to the second direction.  
   
   
       16 . A method of accessing a blood vessel through a blood vessel wall having a longitudinal wall axis, the method comprising: 
 entering the vessel at an angle of less than about 19 degrees with respect to the longitudinal wall axis, and    inserting a lumenal tool into the vessel.    
   
   
       17 . The method of  claim 16 , wherein the first angle is less than about 15 degrees.  
   
   
       18 . The method of  claim 17 , wherein the first angle is less than about 10 degrees.  
   
   
       19 . The method of  claim 18 , wherein the first angle is greater than about 5 degrees.  
   
   
       20 . The method of  claim 16 , further comprising aligning a device with the lumenal wall before the entering.  
   
   
       21 . A method for accessing a biological lumen having a lumen wall and a longitudinal lumen wall axis, the method comprising: 
 inserting in the biological lumen a second elongated member comprising a second elongated member axis,    aligning the second elongated member so that the second elongated member axis is substantially parallel to the longitudinal lumen wall axis, and    inserting in the biological lumen a first elongated member comprising a first elongated member axis.    
   
   
       22 . The method of  claim 21 , wherein an angle between the first elongated member axis and the longitudinal lumen wall axis is less than about 15 degrees.  
   
   
       23 . The method of  claim 22 , wherein an angle between the first elongated member axis and the longitudinal lumen wall axis is less than about 10 degrees.  
   
   
       24 . The method of  claim 21 , wherein the second elongated member comprises a retainer, wherein the method further comprises extending the retainer.  
   
   
       25 . The method of  claim 24 , wherein the retainer comprises a resilient member.  
   
   
       26 . The method of  claim 21 , wherein the second elongated member comprises an inflatable member, the method further comprising inflating the inflatable member.  
   
   
       27 . The method of  claim 21 , wherein the second elongated member extends substantially adjacent to the lumen wall.  
   
   
       28 . A method of closing a vascular opening, the vascular opening having an inside surface and a longitudinal axis, the method comprising: 
 inserting a device in the opening,    applying a force to the inside surface, wherein the force is directed in at least one radially outward direction from the longitudinal axis.    
   
   
       29 . The method of  claim 28 , further comprising maintaining the force.  
   
   
       30 . The method of  claim 29 , wherein maintaining comprises maintaining for less than about 120 minutes.  
   
   
       31 . The method of  claim 28 , wherein the applying a force comprises the device applying at least a part of the force.  
   
   
       32 . The method of  claim 31 , wherein the applying a force comprises the device applying all of the force.  
   
   
       33 . A method for accessing and closing a blood vessel having a vessel wall, wherein the vessel wall has an inside surface and an outside surface, the method comprising: 
 forming an arteriotomy,    deploying a closure augmentation device in the arteriotomy, wherein the closure augmentation device produces pressure on the inside surface and the outside surface.    
   
   
       34 . The method of  claim 33 , wherein the closure augmentation device comprises a filament, and wherein the filament is in the arteriotomy.  
   
   
       35 . The method of  claim 33 , wherein the closure augmentation device comprises a pressure clip.  
   
   
       36 . The method of  claim 33 , wherein the closure augmentation device comprises a pledget.  
   
   
       37 . The method of  claim 33 , wherein the closure augmentation device comprises a toggle.  
   
   
       38 . The method of  claim 33 , wherein the closure augmentation device comprises a suture.  
   
   
       39 . A method for accessing a blood vessel having a vessel wall, wherein the vessel wall has an inside and an outside, the method comprising: 
 forming an arteriotomy in the vessel wall, wherein the arteriotomy has an arteriotomy run and an arteriotomy rise, and wherein the arteriotomy rise is about equal to or less than one-third of the arteriotomy run, and    deploying vascular tools through the arteriotomy.    
   
   
       40 . The method of  claim 39 , wherein forming the arteriotomy further comprises deploying an introduction device through the vessel wall, and wherein the introduction device passes through the vessel wall at substantially various angles with respect to the vessel wall.  
   
   
       41 . The method of  claim 39 , wherein forming the arteriotomy further comprises deploying an introduction device through the vessel wall, and wherein the introduction device cleaves a plane in the lumen wall.  
   
   
       42 . The method of  claim 41 , wherein the plane can be substantially parallel with the lumen wall.  
   
   
       43 . The method of  claim 41 , wherein the blood vessel wall has an adventitia, and wherein the plane is adjacent to the adventitia.  
   
   
       44 . The method of  claim 39 , wherein the arteriotomy has an outside lumen wall opening and an inside lumen wall opening, and wherein the introduction run is the component of the length substantially parallel to the lumen wall between the outside lumen wall opening and the inside lumen wall opening.  
   
   
       45 . The method of  claim 44 , wherein the introduction rise is the component of the length substantially perpendicular to the lumen wall between the outside lumen wall opening and the inside lumen wall opening.  
   
   
       46 . The method of  claim 39 , wherein the arteriotomy rise is about equal to or less than one-fourth of the arteriotomy run.  
   
   
       47 . The method of  claim 39 , wherein the arteriotomy rise is about equal to or less than one-fifth of the arteriotomy run.  
   
   
       48 . A method for accessing a blood vessel having a vessel wall, wherein the vessel wall has an inside and an outside, the method comprising: 
 deploying an introduction device to form an arteriotomy,    moving the introduction device through the vessel wall at a first angle with respect to the vessel wall,    moving the introduction device through the vessel wall at a second angle with respect to the vessel wall, and    entering the inside of the vessel wall with the introduction device.    
   
   
       49 . The method of  claim 48 , wherein the first angle or the second angle is less than about 5 degrees.  
   
   
       50 . The method of  claim 48 , wherein the first angle or the second angle is about 0 degrees.  
   
   
       51 . The method of  claim 48 , wherein the introduction device forms an outer opening on the outside of the vessel wall, and wherein the introduction device forms an inner opening on the inside of the vessel wall, and wherein a vector between the outer inner opening and the outer opening can comprise an introduction run and introduction rise, and wherein the ratio of the introduction rise to the introduction run can be equal to or less than about ½.  
   
   
       52 . The method of  claim 51 , wherein the ratio of the introduction rise to the introduction run can be equal to or less than about ⅓.  
   
   
       53 . The method of  claim 51 , wherein the ratio of the introduction rise to the introduction run can be equal to or less than about ¼.  
   
   
       54 . The method of  claim 51 , wherein the ratio of the introduction rise to the introduction run can be equal to or less than about ⅕.  
   
   
       55 . The method of  claim 51 , wherein the ratio of the introduction rise to the introduction run can be equal to or less than about ⅙.

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