All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The present invention relates to methods and devices for providing transvascular access to blood vessels. Prior devices and methods have been described for providing, e.g., access for placing a central venous line in the jugular vein using a remote vascular entry point, such as the femoral vein. In those prior approaches, a steerable catheter with a bent or bendable tip is guided from the femoral or other entry point to the desired central venous line entry point in the jugular vein. The tip of a sharp wire or stylet is then advanced out of the catheter and through the vessel wall and skin of the patient, and the central venous line is then inserted over the wire or stylet. More details of these prior devices and methods may be found in U.S. application Ser. No. 12/861,716 (filed Aug. 23, 2010); U.S. application Ser. No. 12/366,517 (filed Feb. 5, 2009); and U.S. application Ser. No. 11/424,131 (filed Jun. 14, 2006), the disclosures of which are incorporated herein by reference.
The present invention provides new devices and methods for providing a second entry point to a vessel remote from a first entry point. One aspect of the invention provides a system for providing a second entry point in a vessel remote from a first entry point, including the following elements: a vascular catheter having first and second lumens, the first lumen being adapted to receive a vascular guidewire; a guide tube disposed in the second lumen, the guide tube having a distal end with a preformed curve; a stylet disposed in the guide tube, the stylet having a sharp distal tip adapted to pierce vascular tissue, muscle and skin; a guide tube actuator operatively connected to the guide tube or vascular catheter, the guide tube actuator configured to produce relative movement between the guide tube and the vascular catheter; and a stylet actuator operatively connected to the stylet, the stylet actuator having a stylet advancement mechanism. In some embodiments, the second lumen extends in a curve at its distal end.
In some embodiments, the guide tube actuator and the stylet actuator are supported by a handle at the proximal end of the vascular catheter. In some such embodiments, the guide tube actuator has a slider movably disposed in the handle and operatively connected to the guide tube or vascular catheter. In some embodiments the slider is operatively connected to the guide tube and is configured to advance the guide tube relative to the second lumen of the vascular catheter. In some embodiments the slider is operatively connected to the vascular catheter and configured to move the vascular catheter relative to the guide tube.
In some embodiments the handle includes a first wing and a second wing on opposing sides of the handle with the preformed curvature of the guide tube oriented to extend perpendicular relative to a plane defined by the first and second wings. In some embodiments the slider is on the same side of the handle as the side that the preformed curvature of the guide tube is oriented to extend towards.
In some embodiments, the sharp distal tip includes a conical shaped tip. In some embodiments the sharp distal tip includes a faceted tip.
In some embodiments, the stylet actuator includes a spring. In some such embodiments, the stylet actuator can also have a spring loading actuator and a spring release actuator.
Another aspect of the invention provides a method of providing a second entry point in a vessel of a patient remote from a first entry point. The method may include the following steps: deploying a vascular guidewire into the vessel from the first entry point toward the second entry point; inserting the guidewire into a first lumen of a vascular catheter; advancing the vascular catheter over the guidewire from the first entry point toward the second entry point; advancing a guide tube out of a distal end of a second lumen of the vascular catheter; directing a distal opening of the guide tube towards a wall of the vessel at the second entry point; and advancing a stylet out of the distal end of the guide tube, through the vessel wall and skin of the patient.
In some embodiments directing the distal opening of the guide tube towards the wall of the vessel at the second entry point includes placing the distal opening of the guide tube against the wall of the vessel at the second entry point.
Some embodiments also include the step of inserting a device over the stylet and into the vessel at the second entry point.
In some embodiments, the guide tube has a preformed curve at its distal end, and the step of advancing the guide tube includes the step of permitting the guide tube distal end to assume its preformed curve as the guide tube distal end is advanced out of the distal end of the second lumen of the vascular catheter.
In some embodiments, the second lumen of the vascular catheter extends in a curve at its distal end, and the step of advancing the guide tube includes the step of engaging a camming surface in the curve of the second lumen with a distal end of the guide tube to advance the distal end of the guide tube away from a longitudinal axis of the vascular catheter and toward a wall of the vessel.
In some embodiments, the step of advancing the guide tube includes the step of moving an actuator in a handle at the proximal end of the vascular catheter. In some embodiments moving the actuator advances the guide tube relative to the second lumen of the vascular catheter. In some embodiments moving the actuator proximally retracts the vascular catheter relative to the guide tube
In some embodiments, the step of advancing the stylet includes the step of operating a stylet actuator in a handle at the proximal end of the vascular catheter. In some such embodiments, operation of the actuator releases a spring. The method may also include the step of loading the spring prior to the step of releasing the spring.
Some embodiments include verifying the positioning of the guide tube after placing the distal opening of the guide tube against the wall of the vessel at the second entry point prior to advancing the stylet. Verifying can include using fluoroscopy to verify the position of the guide tube.
Some embodiments include adjusting the orientation of the handle prior to advancing the guide tube to orient the vascular catheter such that when the guide tube is advanced out of the distal end of the second lumen, the guide tube extends from the vascular catheter towards the skin of the patient at the second entry point.
In some embodiments the first entry point is selected from the group consisting of: the femoral vein and femoral artery, and the second entry point is selected from the group consisting of: the internal jugular vein, subclavian vein, carotid artery, axillary artery, and subclavian artery.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
In some embodiments, the vascular catheter has an optional guidewire lumen. In the embodiments shown in
The handle 44 can include a top portion 45A and a bottom portion 45B.
In addition to the guidewire lumen 46, device 40 has a stylet lumen 50 extending from the handle 44 to an opening 54 toward the distal end of the catheter. In some embodiments, the stylet lumen curves at its distal end to form a camming surface 56. A curved stylet lumen with a camming surface 56 is shown in
In some embodiments the stylet lumen 50 does not have a curved camming surface. For example, the stylet lumen 50 can be substantially cylindrical as illustrated in
The stylet 58 (formed, e.g., from Nitinol with a diameter of 0.014 inches) enclosed by the cover tube 60 (such as a 0.025 inch diameter Nitinol hypotube) extends from an actuator 51, 52 and 53 in the handle 44 toward the distal end of device 40. In some embodiments, cover tube 60 has a preformed curve, such as a 90 degree curve, at its distal end. The optional camming surface 56 can promote the curvature of the cover tube 60.
Stylet 58 has a sharp distal point 62 adapted to penetrate tissue, such as blood vessels, muscle, and skin. The sharp distal point can be part of a tip design having various dimensions and shapes. In some embodiments a faceted tip 80 is used.
In use, e.g., to provide a jugular vein second entry point using the femoral vein as a first entry point, catheter 40 is inserted into the femoral vein over the guidewire 30 and advanced adjacent to the desired exit point 65 (
The cover tube 60 is then advanced out of opening 54 by moving a slide button 51 proximally in handle 44, at which point it assumes its curved shape, as shown in
The orientation of the extended cover tube 60 can be determined based on the orientation of the handle 44. The slide button 51 engages with the top portion 45A of the handle 44. The slide button 51, as illustrated in the figures, is substantially perpendicular to a plane defined by the opposing wings 48 that extends along a length of the handle 44, e.g. the plane defined by the area where the top portion 45A of the handle 44 contacts the bottom portion 45B of the handle 44. The cover tube 60 extends upwards from the stylet lumen 50 and is also substantially perpendicular to the plane defined by the opposing wings 48 extending along a length of the handle 44. The positioning and orientation of the cover tube 60 after it has been advanced can also be visually verified, for example using fluoroscopy prior to deploying the stylet. The stylet actuator is loaded by pulling proximally on a spring-load mechanism 52 in handle 44, as shown in
The guidewire 30 and cover tube 60 can also be used to securely position the device with a desired orientation in the vessel. The guidewire can extend from the distal end of the catheter 40 along one area of the vein wall 66. The guide tube 60 extends towards a vein wall 66 opposing the vein wall 66 that the guidewire extends along and in a substantially perpendicular orientation to the guidewire 30, as illustrated in
Various sizes can be used for the cover tube 60. The configuration of the pre-formed cover tube can be varied to use different shapes. The length and pre-formed configuration of the cover tube 60 can be selected based on the size of the vessel to be accessed.
In some embodiments the cover tube 60 is not fully extended from the vascular catheter 42. For example, the cover tube 60 may not be fully extended to accommodate the specific geometry and size of vessel. In smaller diameter blood vessels there may not be enough space to fully extend the cover tube; however, the cover tube 60 and stylet 58 can properly function partially extended from the vascular catheter.
In some embodiments, a smooth tapered wire cap 67 may be placed on the distal end of stylet 58, and the stylet 58 may be tilted slightly at an angle, as shown in
Modifications of the invention will be apparent to those skilled in the art. Different lengths and diameters of catheter, cover tube and stylet may be used depending upon the application. The length of travel of the stylet and cover tube may also be varied. As an alternative to a rapid exchange guidewire arrangement, the catheter may have a guidewire lumen extending its entire length. The guidewire, cover tube and stylet may also share the same lumen.
The devices disclosed herein can be configured to access different types of blood vessels and other hollow viscera including the bowel/intestine/gastrointestinal (GI) tract, ureter, bladder, airway, etc. In some embodiments the devices are used to access veins. In some embodiments the devices are used to access arteries. The devices can be introduced to the vascular system at a first entry point. Examples of first entry points include the femoral vein and femoral artery. The devices can be advanced to the desired target location for the formation of the second entry point. Examples of second entry points include the jugular vein, subclavian vein, carotid artery, axillary artery, and subclavian artery. The stylet can be advanced through the blood vessel wall, tissue, and skin to form the second entry point. Multiple second entry points can be formed at different locations. After formation of the second entry point a catheter or other medical device can be advanced over the stylet for access to the vascular system at the second entry point. Subsequent medical procedures can then be performed as desired.
In some application multiple entry points may be desirable. The devices disclosed herein can be used to make multiple entry points. The stylet 58 can be used to make a desired first entry point followed by introducing a device for access at the first entry point such as a catheter, as shown in
Animal testing was performed using the vascular catheter devices disclosed herein. The vascular catheter was introduced to the femoral vein at a first entry point. The catheter was advanced over a guidewire to the desired target location for forming the second entry point. In one test the cover tube and stylet were deployed to puncture the vein wall, tissue, and skin at the jugular vein. An additional entry point was formed at the subclavian vein after forming the entry point in the jugular vein. In another procedure the vascular catheter was introduced into the femoral artery as the first entry point. The catheter was advanced to the carotid artery where the cover tube and stylet were deployed to form an entry point in the carotid artery.
Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined in part by the appended claims.
This application is a divisional of U.S. patent application Ser. No. 13/906,122 filed May 30, 2013, now issued as U.S. Pat. No. 9,220,874, which claims priority to U.S. Provisional Application No. 61/653,182, filed May 30, 2012, the disclosures of which are incorporated by reference as if fully set forth herein.
|4559039||Ash et al.||Dec 1985||A|
|4790825||Bernstein et al.||Dec 1988||A|
|4966163||Kraus et al.||Oct 1990||A|
|5492530||Fischell et al.||Feb 1996||A|
|5685820||Riek et al.||Nov 1997||A|
|5733248||Adams et al.||Mar 1998||A|
|6047700||Eggers et al.||Apr 2000||A|
|6102926||Tartaglia et al.||Aug 2000||A|
|6190353||Makower et al.||Feb 2001||B1|
|6217527||Selmon et al.||Apr 2001||B1|
|6475226||Belef et al.||Nov 2002||B1|
|6508777||Macoviak et al.||Jan 2003||B1|
|6554794||Mueller et al.||Apr 2003||B1|
|6623480||Kuo et al.||Sep 2003||B1|
|7008979||Schottman et al.||Mar 2006||B2|
|7648517||Makower et al.||Jan 2010||B2|
|8019420||Hine et al.||Sep 2011||B2|
|8241311||Ward et al.||Aug 2012||B2|
|8568435||Pillai et al.||Oct 2013||B2|
|9220874||Filial et al.||Dec 2015||B2|
|20010012924||Milo et al.||Aug 2001||A1|
|20020004666||Schwager et al.||Jan 2002||A1|
|20020029060||Hogendijk et al.||Mar 2002||A1|
|20020133168||Smedley et al.||Sep 2002||A1|
|20020169377||Khairkhahan et al.||Nov 2002||A1|
|20040039371||Tockman et al.||Feb 2004||A1|
|20040059280||Makower et al.||Mar 2004||A1|
|20040082850||Bonner et al.||Apr 2004||A1|
|20040133168||Salcudean et al.||Jul 2004||A1|
|20040181238||Zarbatany et al.||Sep 2004||A1|
|20050101984||Chanduszko et al.||May 2005||A1|
|20050149097||Regnell et al.||Jul 2005||A1|
|20050209579||Yacoubian et al.||Sep 2005||A1|
|20060009737||Whiting et al.||Jan 2006||A1|
|20060135962||Kick et al.||Jun 2006||A1|
|20060247750||Seifert et al.||Nov 2006||A1|
|20070203515||Heuser et al.||Aug 2007||A1|
|20080215008||Nance et al.||Sep 2008||A1|
|20080249565||Michler et al.||Oct 2008||A1|
|20090112050||Farnan et al.||Apr 2009||A1|
|20100249491||Farnan et al.||Sep 2010||A1|
|20140142418||Gurley et al.||May 2014||A1|
|WO 2004018029||Mar 2004||WO|
|WO 2005053547||Jun 2005||WO|
|WO 2011068540||Jun 2011||WO|
|WO 2013119547||Aug 2013||WO|
|Faul et al.; Vascular Disease Management; vol. 5; No. 5; pp. 128-133; Sep./Oct. 2008.|
|Huang et al.; Evaluation of the needle technique for producing an arteriovenous fistula; Journal of Applied Physiology; vol. 77(6); pp. 2907-2911; Dec. 1994.|
|Khanna et al.; Sharpening of hollow silicon microneedles to reduce skin penetration force; J. Micromech. Microeng.; vol. 20; No. 4, pp. 045011 (8 pgs.); Mar. 15, 2010.|
|LuMEND, INC.; Outback LTD re-entry catheter; Product Resources (http://www.lumend.com/Images/Technology/Product/brochure.pdf) This web address was available to applicant (s) at least as of (Jul. 19, 2006).|
|Mewissen, Mark; Revascularization of long FP arterial occlusions; Endovascular Today; pp. 2-4; Mar. 2004.|
|O'Callaghan et al.; Dynamics of stab wounds: force required for penetration of various cadaveric human tissues; Forensic Sci. Int'l; vol. 104; pp. 173-178; Oct. 11, 1999.|
|Pillai, Lakshmikumar; U.S. Appl. No. 11/381,229 entitled “Methods of Transvascular Retrograde Access Placement and Devices for Facilitating Therein,” filed May 2, 2006.|
|Office Action dated Sep. 7, 2018 for U.S. Appl. No. 15/347,478.|
|Office Action dated Sep. 27, 2018 for U.S. Appl. No. 15/464,055.|
|20160074623 A1||Mar 2016||US|