Source: http://www.google.com/patents/US8002791?dq=KOI-18
Timestamp: 2014-12-20 06:08:19
Document Index: 94888843

Matched Legal Cases: ['Application No. 08011884', 'Application No. 180497', 'Application No. 179173', 'Application No. 180497', 'Application No. 179173', 'Application No. 2005244834', 'Application No. 2007', 'Application No. 05787529', 'Application No. 2007', 'Application No. 2008', 'Application No. 200580023327', 'Application No. 2005272102', 'Application No. 2005800293656', 'Application No. 2006800252468', 'Application No. 2006247355', 'Application No. 179173', 'Application No. 180497', 'Application No. 2006800252468', 'Application No. 2005800293656']

Patent US8002791 - Access and closure device and method - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsDevices 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....http://www.google.com/patents/US8002791?utm_source=gb-gplus-sharePatent US8002791 - Access and closure device and methodAdvanced Patent SearchPublication numberUS8002791 B2Publication typeGrantApplication numberUS 11/544,196Publication dateAug 23, 2011Filing dateOct 6, 2006Priority dateMay 12, 2004Also published asCA2566743A1, CN101431948A, CN101431948B, EP1748735A2, EP1748735A4, EP1972282A2, EP1972282A3, EP1972282A8, EP2499976A2, EP2499976A3, US7998169, US8002792, US8002793, US8012168, US20050267520, US20070027454, US20070027455, US20070032802, US20070032803, US20070032804, US20120089166, WO2005112791A2, WO2005112791A3Publication number11544196, 544196, US 8002791 B2, US 8002791B2, US-B2-8002791, US8002791 B2, US8002791B2InventorsD. Bruce ModesittOriginal AssigneeArstasis, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (102), Non-Patent Citations (79), Classifications (38), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetAccess and closure device and methodUS 8002791 B2Abstract 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.
a. inserting an anchor across a vessel wall into a lumen defined by the vessel wall through a first arteriotomy that has a first angle with respect to the vessel wall;
b. applying a force to the anchor to position an adjacent portion of the vessel wall in a desired configuration relative to the anchor;
c. creating a tract between an exterior portion of a vessel wall and a lumen defined by the vessel wall with a device passing though a proximal extension of the anchor, while maintaining the vessel wall portion in the desired configuration with the anchor wherein a distal portion of the tract defines a second angle with respect to the vessel wall and wherein the first angle is larger than the second angle; and
d. expanding the tract with a sheath so that a procedure may be performed therethrough, wherein the tract is defined between overlapping tissue portions of the vessel wall, and wherein after the procedure has been performed and the device and sheath have been withdrawn from the tract, blood pressure acting on the vessel causes the overlapping tissue portions to collapse and self-seal.
2. The method of claim 1, wherein the device comprises a first introducer, and wherein creating the tract comprises introducing the first introducer into the lumen to locate a surface of the vessel wall. 3. The method of claim 2, wherein the device further comprises a second introducer, and wherein creating the tract further comprises introducing the second introducer substantially laterally through the vessel wall.
4. The method of claim 1, wherein the vessel comprises an artery.
5. The method of claim 1, wherein the tract includes at least one sloped region.
6. The method of claim 1, wherein the force is a proximal force configured to urge the anchor into contact against the vessel wall.
7. The method of claim 6, wherein desired contact configuration comprises one in which a portion of the anchor is aligned to be substantially parallel with a wall surface of the lumen of the vessel. Description
CROSS-REFFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 10/844,247, filed may 12, 2004, which is hereby incorporated by reference in its entirety.
BRIEF SUMMARY OF THE INVENTION A device for accessing a biological lumen is disclosed. The biological lumen has a lumen wall having a longitudinal lumen wall axis. The device has an elongated member that has a longitudinal member axis. The member is configured to access the lumen at a first angle. The first angle is defined by the longitudinal lumen wall axis and the longitudinal member axis. The first angle is less than about 19 degrees.
Also disclosed is a method for accessing a biological lumen. The biological lumen has a lumen wall and a longitudinal lumen wall axis. The method includes inserting in the biological lumen a second elongated member. The second elongated member has a second elongated member axis. The method also includes aligning the second elongated member so that the second elongated member axis is substantially parallel to the longitudinal lumen wall axis. Further, the method includes inserting in the biological lumen a first elongated member comprising a first elongated member axis. Additionally disclosed is a method of closing a vascular opening. The vascular opening has an inside surface and a longitudinal axis. The method includes inserting a device in the opening and applying a force to the inside surface. The force is directed in at least one radially outward direction from the longitudinal axis.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front perspective view of an embodiment of the arteriotomy device.
FIG. 7 is a close-up view of an embodiment of the arteriotomy device with the introduction device deployed. FIGS. 8 and 9 are side views of various embodiments of the arteriotomy device with the introduction devices deployed.
FIG. 26 illustrates a method for deploying a guidewire in a cross-section of a lumen. FIGS. 27-30 illustrate a method for deploying the introduction device in a cross-section of a lumen.
FIG. 48 is a close-up view of FIG. 47. FIG. 49 illustrates a method of using the toggle deployment device in a cross-section of a lumen.
FIG. 52 illustrates FIG. 51 with a portion of the toggle deployment device shown in section: E-E.
FIG. 58 is a close-up view-of FIG. 59.
FIGS. 67 and 68 illustrate a method for attaching guidewire to the anchor. DETAILED DESCRIPTION FIGS. 1 through 3 illustrate a device for accessing a biological lumen, such as an arteriotomy device 2. The arteriotomy device 2 can have a delivery guide 4. The delivery guide 4 can be slidably attached to an anchor 6. The anchor 6 can be rigid, flexible or combinations thereof. The anchor 6 can be resilient, deformable or combinations thereof. The anchor 6 can be retractable and extendable from the delivery guide 4. The delivery guide 4 can have an introducer lumen 8. The introducer lumen 8 can have an introducer lumen exit port 10. The introducer lumen exit port 10 can be on the surface of the delivery guide 4.
The anchor angle first sub-section 16 can have an anchor angle first subsection diameter 22 from about 0.38 mm (0.015 in.) to about 1.0 mm (0.039 in.), for example about 0.71 mm (0.028 in.). The anchor angle second sub-section 18 can have an anchor angle second sub-section diameter 24 from about 0.38 mm (0.015 in.) to about 1.0 mm (0.039 in.), for example about 0.71 mm (0.028 in.).
The elements of the arteriotomy device 2 and/or the fabric can be filled and/or coated with an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. The agents within these matrices can include radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN� from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL� from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX� from Merck & Co., Inc., Whitehouse Station, N.J.; CELEBREX� from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE�, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E2 Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties.
FIGS. 6 and 7 illustrate that the arteriotomy device 2 can have an introduction device 38. The introduction device 38 can be slidably attached to the introducer lumen 8. The introduction device 38 can have a hollow needle (as shown in FIG. 6). The introduction device 38 can have a solid needle (as shown in FIG. 7). The introduction device 38 can have a guidewire. The introduction device 38 can have an introduction longitudinal axis 40. The intersection of the introduction longitudinal axis 40 and the anchor longitudinal axis 28 can be an introduction angle 42. The introduction angle 42 can be less than or equal to about 19�, more narrowly less than or equal to about 15�, yet more narrowly from about 5� to about 10�, for example about �10.
FIG. 10 illustrates that a lumenal retainer 48 can have a first retracted configuration. The lumenal retainer 48 can be seated in a lumenal retainer port 50. The lumenal retainer port 50 can be in the anchor 6. The lumenal retainer 48 can be a wire, scaffold or stent�for example made from a deformable or resilient material, such as a shape memory alloy�an inflatable balloon, or combinations thereof. Intralumenal inflatable balloons, such as those inflated with saline solution or carbon dioxide, are known to those having ordinary skill in the art. The lumenal retainer 48 can extend into the delivery guide 4.
FIGS. 15 through 20 illustrate various supplemental closure devices. The supplemental closure devices can, be completely or partially bioabsorbable, bioresorbable, bioadsorbable or combinations thereof. The supplemental closure devices can be made from homografts, heterografts or combinations thereof. The supplemental closure devices can be made from autografts, allografts or combinations thereof. FIG. 15 illustrates a tensioner 58. The tensioner 58 can be resilient, deformable, or combinations thereof. The tensioner 58 can have a tensioner longitudinal axis 60. The tensioner 58 can have a resilient element, such as a spring, for example a tensioner head 62. The tensioner head 62 can have a tensioner first shoulder 64. The tensioner head 62 can have a tensioner second shoulder 66. The tensioner first and second shoulders 64 and 66 can rotatably attached to a separate or integral tensioner first leg 68 and a separate or integral tensioner second leg 70, respectively. The tensioner first and second legs 68 and 70 can attach to tensioner first and second feet 72 and 74, respectively.
FIG. 16 illustrates a tensioner first strut 80 that can attach to the tensioner first leg 68 and the tensioner second leg 70. The tensioner first leg 68 can be resilient, deformable or combinations thereof. A tensioner second strut 82 can attach to the tensioner first leg 68 and the tensioner second leg 70. The tensioner second leg 70 can be resilient and/or deformable. The tensioner 58 can have no tensioner head 62. The tensioner 58 can have more than two tensioner struts 80 and 82. FIG. 17 illustrates a pressure clip 84. The pressure clip 84 can be resilient. The pressure clip 84 can be deformable. The pressure clip 84 can have a pressure clip longitudinal axis 86. The pressure clip 84 can have a pressure clip head 88. The pressure clip head 88 can be rotatably attached to a separate or integral pressure clip first leg 90. The pressure clip head 88 can be rotatably attached to a separate or integral pressure clip second leg 92. The pressure clip can have a pressure clip first end 94 and a pressure clip second end 96. The pressure clip first leg 90 can terminate in the pressure clip first end 94. The pressure clip second leg 92 can terminate in the pressure clip second end 96. The pressure clip first leg 90 and/or the pressure clip second leg 92 can be biased toward the pressure clip longitudinal axis 86.
FIG. 19 illustrates a toggle 100. The toggle 100 can have a toggle first end 102. The toggle 100 can have a toggle second end 104. The toggle first and/or second ends 102 and/or. 104 can be bars, dowels, rods, beams, or combinations thereof. The toggle 100 can have a filament 106. The filament 106 can be fixedly attached at a filament first end 107 to the toggle first end 102. The filament 106 can be fixedly attached at a filament second end 109 to the toggle second end 104. The filament 106 can be resilient or deformable. The filament 106 can be substantially flexible.
The supplemental closure devices can be covered with a fabric, for example polyester (e.g., DACRON� from E. I. du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof Methods of covering an implantable device with fabric are known to those having ordinary skill in the art.
The introduction device 38 can pass through an introduction run 132 and an introduction rise 134. The introduction run 132 can be the component of the length of the introduction device. 38 in the lumen wall 116 that is parallel to the lumen wall 116. The introduction run 132 can be the component of the length parallel to the lumen wall 116 between the opening of the second arteriotomy 128 on the outside of the lumen wall 116 and the opening of the second arteriotomy 128 on the inside lumen wall surface 118. The introduction run 132 can be from about 0.10 cm (0.010 in.) to about 3.810 cm (1.500 in.), for example about 0.64 cm (0.25 in.).
FIG. 26 illustrates that the introduction device 38, for example a hollow needle, can act as a pathway for a lumenal tool, for example tools such as a guidewire 168, to be deployed, as shown by arrow, into the lumen 114. The introduction device 38, for ex ample a solid needle, can be removed from the second arteriotomy 128 and the lumenal tool can be deployed through, for example, the introducer lumen exit port 10, and the second arteriotomy 128. The introduction device 38 can be the lumenal tool, for example a guidewire. The introduction device 38 can be further deployed and used as a lumenal tool after passing through the lumen wall 116. FIGS. 27 through 30 illustrates a method of deploying the introduction device 38 that can have a pre-formed bend. As shown in FIG. 27, the arteriotomy device 2 can be configured to deploy the introduction device 38 at the introduction angle 42 from about 0� to about 5�, for example about 0�.
As shown in FIG. 28, the introduction device 38 can be pushed, as shown by arrow, through the lumen wall 116. The introduction device 38 can cleave a plane in the lumen wall 116. The plane can be substantially parallel with the lumen wall surface 118. The introduction device 38 can be adjacent to the adventitia in a blood vessel. The introduction device 38 can be advanced along the subintimal or submedial cleavage plane in a blood vessel. Once the lumen wall has been cleaved, a subintimal angioplasty can be performed as known to one having ordinary skill in the art. Once the lumen wall has been cleaved, a remote endarterectomy can be performed as known to one having ordinary skill in the art. Bent and straight introduction devices 38 can be swapped during use to selectively cleave the lumen wall 116. Tools, such as guidewires can be inserted through hollow introduction devices 38 to selectively cleave the lumen wall 116.
As shown in FIG. 29, when the bend in the introduction device 38 moves into the lumen wall 116, the introduction device 38 can rotate, as shown by arrow, toward the biological lumen 114. As shown in FIG. 30, the bend in the introduction device 38 can continue to rotate the introduction device 38 toward the biological lumen 114. As described infra, the introduction device 38 can enter the lumen 114. FIG. 31 illustrates that the introduction device 38 that can have the bend can act as a pathway for a lumenal tool, as described infra. An introducer sheath can be inserted over the guidewire 168 and/or the introduction device 38. The introducer sheath can be less than about 22 French (7.3 mm, 0.29 in. diameter) or less than the diameter of the lumen to which the introducer sheath is introduced. The introducer sheath can be, for examples, about 6 French (2.3 mm, 0.092 in. diameter), and about 8 French (2.67 mm, 0.105 in. diameter). The introducer sheath can be known to one having ordinary skill in the art, for example the introducer sheath described in U.S. Pat. No. 5,183,464 to Dubrul, et al.
FIGS. 35 and 36 illustrated method of deploying the tensioner 58. As shown in FIG. 35, the tensioner 58 can be in a compressed configuration. The tensioner 58 can be exposed to the compressive forces, as shown by arrows 144. The compressive forces can be applied by a retractable sheath, clamps, other methods known to one having ordinary skill in the art, or combinations thereof. A deployment force, shown by arrow 146, can deploy the tensioner 58 into the arteriotomy 120 or 128.
The arteriotomy 120 or 128 can have an arteriotomy diameter 148. The arteriotomy diameter 148 can be from about 0.5 mm (0.020 in.) to about 400 mm (15 in.), yet a narrower range from about 1.0 mm (0.040 in.) to about 10.2 mm (0.400 in.), for example about 2.54 mm (0.100 in.). When in the compressed configuration, the tensioner inter-leg outer diameter 78 can be smaller than the arteriotomy diameter 148. The tensioner first and second shoulders 64 and 66 can be wide enough to interference fit with the arteriotomy 120 or 128. The tensioner first and second shoulders 64 and 66 can dissipate force on the lumen wall surface 118. As shown in FIG. 36, the compressive forces can be removed from the tensioner 58. The tensioner first and second leg 68 and 70 can expand, as shown by arrows. The tensioner 58 can force the arteriotomy 120 or 128 into a substantially or completely flat and/or closed and/or stretched configuration. The walls of the arteriotomy 120 or 128 can come into close contact.
The arteriotomy height 152 can be about the tensioner leg diameter 76. The arteriotomy height 152 can be less than about 0.51 mm (0.020 in.), more narrowly, less than about 0.38 mm (0.015 in.). The arteriotomy height 152 can be from about 0.25 mm (0.010 in.) to about 1.3 mm (0.050 in.), for example about 0.38 mm (0.015 in.). The arteriotomy height 152 can be small enough to enable cell growth, blood clotting, acoustic sealing, heat sealing, gluing, enhanced self-sealing and combinations thereof across the arteriotomy 120 or 128.
FIG. 39 illustrates contracting, and/or widening, and/or releasing and/or relaxing the pressure clip second end 96. The pressure clip sheath 98 can be translated, as shown by arrow, along the pressure clip second leg 92 and off of the pressure clip second end 96. The pressure clip second end 96 can be contracted, and/or widened, and/or released and/or relaxed after the pressure clip 84 is deployed to the arteriotomy. As shown in FIG. 40, after the pressure clip second leg 92 is deployed through the first arteriotomy 120, the pressure clip second leg 92 can be released or deformed so as to rotate with respect to the pressure clip head 88. The pressure clip head 88 can seat in the first arteriotomy 120. The pressure clip first and second legs 90 and 92 can apply force, as shown by arrows, to the first and second webs 140 and 142, respectively.
FIGS. 51 and 52 illustrate that the toggle deployment device 159 can be placed in the second delivery configurtion. If the delivery needle port is in, or adjacent to, the lumen wall 116 when the toggle deployment device 159 is placed in the second delivery configuration, the delivery needle 162 can enter the lumen wall 116. For example, the delivery needle 162 can enter the second web 142. The delivery needle 162 can exit the second web 142 and enter, as shown by arrows, the biological lumen 114.
FIG. 63 illustrates that the delivery needle 162 can be retracted into the delivery guide 4 and/or the filament 106 can be pulled taught, both shown by arrow. The toggle first end 102 can form an interference fit with the lumen wall surface 118. The toggle second end 104 (not shown in FIG. 63) can be slidably translated on the filament 106 down to, and form an interference fit with, the outside of the lumen wall 116. The length of the filament 106 on the opposite side of toggle second end 104 from the toggle first end 102 can be cut, snapped, torn or otherwise removed. FIG. 64 illustrates an introducer needle 165 that can have an end inserted, as shown by arrow, through the lumen wall 116 and into the lumen 114, for example by using the Seldinger technique. The introducer needle 165 can be hollow and/or have a longitudinal channel. FIG. 65 illustrates that the guidewire 168 can be deployed, shown by arrows, through the hollow and/or longitudinal channel of the introducer needle 165.
Where applicable, the methods described supra for deploying any supplemental closure device can be used for deploying any of the other supplementary deployment device. It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements shown with any embodiment are exemplary for the specific embodiment and can be used on other embodiments within this disclosure. 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Biological Chemistry 275(32):24583-24589.Classifications U.S. Classification606/213, 606/215International ClassificationA61B17/06, A61B17/128, A61B17/08, A61B17/04, A61B17/064, A61B17/068, A61B17/00, A61B17/12Cooperative ClassificationA61B2017/00637, A61B2017/0496, A61B17/1285, A61B17/0057, A61B17/068, A61B2017/0417, A61B17/0644, A61M25/01, A61B17/0401, A61B17/3403, A61B2017/00659, A61M25/04, A61B2017/06052, A61B2017/00676, A61B17/12009, A61B2017/0406, A61B2017/0419, A61B2017/3405, A61B17/0469, A61B2017/0403, A61B2017/00672, A61M25/06, A61M2025/0002European ClassificationA61M25/06, A61B17/34D, A61M25/01, A61M25/04, A61B17/00PLegal EventsDateCodeEventDescriptionJan 11, 2007ASAssignmentOwner name: ARSTASIS, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MODESITT, D. BRUCE;REEL/FRAME:018748/0116Effective date: 20061106RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google