Patent 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.

Full Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates to the field of accessing a biological lumen and closing the access port thereby created.  
         [0003]     2. Description of the Related Art  
         [0004]     A number of diagnostic and interventional vascular procedures are now performed translumenally, where a catheter is introduced to the vascular system at a convenient access location—such as the femoral, brachial, or subclavian arteries—and guided through the vascular system to a target location to perform therapy or diagnosis. When vascular access is no longer required, the catheter and other vascular access devices must be removed from the vascular entrance and bleeding at the puncture site must be stopped.  
         [0005]     One common approach for providing hemostasis is to apply external force near and upstream from the puncture site, typically by manual compression. This method is time-consuming, frequently requiring one-half hour or more of compression before hemostasis. This procedure is uncomfortable for the patient and frequently requires administering analgesics. Excessive pressure can also present the risk of total occlusion of the blood vessel, resulting in ischemia and/or thrombosis.  
         [0006]     After hemostasis is achieved by manual compression, the patient is required to remain recumbent for six to eighteen hours under observation to assure continued hemostasis. During this time bleeding from the vascular access wound can restart, potentially resulting in major complications. These complications may require blood transfusion and/or surgical intervention.  
         [0007]     Bioabsorbable fasteners have also been used to stop bleeding. Generally, these approaches rely on the placement of a thrombogenic and bioabsorbable material, such as collagen, at the superficial arterial wall over the puncture site. This method generally presents difficulty locating the interface of the overlying tissue and the adventitial surface of the blood vessel. Implanting the fastener too far from the desired location can result in failure to provide hemostasis. If, however, the fastener intrudes into the vascular lumen, thrombus can form on the fastener. Thrombus can embolize downstream and/or block normal blood flow at the thrombus site. Implanted fasteners can also cause infection and auto-immune reactions/rejections of the implant.  
         [0008]     Suturing methods are also used to provide hemostasis after vascular access. The suture-applying device is introduced through the tissue tract with a distal end of the device located at the vascular puncture. Needles in the device draw suture through the blood vessel wall on opposite sides of the punctures, and the suture is secured directly over the adventitial surface of the blood vessel wall to close the vascular access wound.  
         [0009]     To be successful, suturing methods need to be performed with a precise control. The needles need to be properly directed through the blood vessel wall so that the suture is well anchored in tissue to provide for tight closure. Suturing methods also require additional steps for the surgeon.  
         [0010]     Due to the deficiencies of the above methods and devices, a need exists for a more reliable vascular closure method and device. There also exists a need for a vascular closure device and method that does not implant a foreign substance and is self-sealing. There also exists a need for a vascular closure device and method requiring no or few extra steps to close the vascular site.  
       BRIEF SUMMARY OF THE INVENTION  
       [0011]     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.  
         [0012]     The first angle can be less than about 15 degrees. The first angle can be less than about 10 degrees. The device can also have an anchor. The anchor can be configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen wall axis.  
         [0013]     The device can also have a retainer. The retainer can be configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen axis.  
         [0014]     Another device for accessing a biological lumen is disclosed. The biological lumen has a lumen wall and a longitudinal lumen wall axis. The device has a first elongated member and a second elongated member. The first elongated member has a first elongated member axis. The second elongated member has a second elongated member axis. The second elongated member is configured so that the second elongated member axis is parallel to the longitudinal lumen wall axis.  
         [0015]     The second elongated member can have a retainer. The retainer can have an inflatable member. The retainer can have a resilient member. The second elongated member can extend substantially adjacent to the lumen wall.  
         [0016]     Also disclosed is a device for closing an opening on a biological lumen wall. The device has a longitudinal axis, a first force-applying member, a second force-applying member, and a resilient member. The resilient member provides to the first and the second force-applying members a force that is radially outward with respect to the longitudinal axis.  
         [0017]     A method of accessing a blood vessel through a blood vessel wall is also disclosed. The blood vessel wall has a longitudinal wall axis. The method includes entering the vessel at an angle of less than about 19 degrees with respect to the longitudinal wall axis. The method also includes inserting a lumenal tool into the vessel.  
         [0018]     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.  
         [0019]     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.  
         [0020]     The method can include maintaining the force. The applying a force can include the device applying at least a part of the force. The applying of a force can include the device applying all of the force.  
         [0021]     Also disclosed is a method for accessing and closing a blood vessel having a vessel wall. The vessel wall can have an inside surface and an outside surface. The method includes forming an arteriotomy and deploying a closure augmentation device in the arteriotomy. The closure augmentation device produces pressure on the inside surface and the outside surface. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]      FIG. 1  is a front perspective view of an embodiment of the arteriotomy device.  
         [0023]      FIG. 2  is a side view of the arteriotomy device of  FIG. 1 .  
         [0024]      FIG. 3  is a close-up view of the arteriotomy device of  FIG. 1 .  
         [0025]      FIGS. 4 and 5  are close-up views of various embodiments of the anchor.  
         [0026]      FIG. 6  is a side perspective view of an embodiment of the arteriotomy device with the introduction device deployed.  
         [0027]      FIG. 7  is a close-up view of an embodiment of the arteriotomy device with the introduction device deployed.  
         [0028]      FIGS. 8 and 9  are side views of various embodiments of the arteriotomy device with the introduction devices deployed.  
         [0029]      FIG. 10  is a bottom perspective view of an embodiment of the arteriotomy device.  
         [0030]      FIG. 11  is a side view of an embodiment of the arteriotomy device with the lumenal retainer deployed.  
         [0031]      FIG. 12  is a bottom perspective view of an embodiment of the arteriotomy device with the lumenal retainer deployed.  
         [0032]      FIG. 13  is a side perspective view of an embodiment of the arteriotomy device.  
         [0033]      FIG. 14  is a side perspective view of an embodiment of the arteriotomy device with the entry wall retainer deployed.  
         [0034]      FIGS. 15 and 16  illustrate various embodiments of the tensioner.  
         [0035]      FIGS. 17 and 18  illustrate various embodiments of the pressure clip.  
         [0036]      FIGS. 19 and 20  illustrate various embodiments of the toggle.  
         [0037]      FIG. 21  illustrates a method for deploying the arteriotomy device in a cross-section of a lumen.  
         [0038]      FIGS. 22 and 23  illustrate methods for deploying the retainers in a cross-section of a lumen.  
         [0039]      FIGS. 24 and 25  illustrate a method for deploying the introduction device in a cross-section of a lumen.  
         [0040]      FIG. 26  illustrates a method for deploying a guidewire in a cross-section of a lumen.  
         [0041]      FIGS. 27-30  illustrate a method for deploying the introduction device in a cross-section of a lumen.  
         [0042]      FIG. 31  illustrates a method for deploying a guidewire in a cross-section of a lumen.  
         [0043]      FIG. 32  illustrates a portion of an arteriotomized lumen.  
         [0044]      FIG. 33  illustrates section A-A of  FIG. 28 .  
         [0045]      FIGS. 34-36  illustrate a method for deploying a tensioner in a see-through portion of lumen wall.  
         [0046]      FIGS. 37-40  illustrate methods for deploying various embodiments of the pressure clip in a cross-section of a lumen.  
         [0047]      FIG. 41  illustrates a method of using a suture on a portion of an arteriotomized lumen.  
         [0048]      FIG. 42  illustrates section B-B of  FIG. 41  with the out-of-section suture.  
         [0049]      FIG. 43  illustrates a method of using pledgets on a portion of an arteriotomized lumen.  
         [0050]      FIG. 44  illustrates section C-C of  FIG. 43 .  
         [0051]      FIG. 45  illustrates an embodiment of the toggle deployment device in a first configuration.  
         [0052]      FIG. 46  is a close-up view of  FIG. 45 .  
         [0053]      FIG. 47  illustrates an embodiment of the toggle deployment device in a second configuration.  
         [0054]      FIG. 48  is a close-up view of  FIG. 47 .  
         [0055]      FIG. 49  illustrates a method of using the toggle deployment device in a cross-section of a lumen.  
         [0056]      FIG. 50  illustrates  FIG. 49  with a portion of the toggle deployment device shown in section D-D.  
         [0057]      FIG. 51  illustrates a method of using the toggle deployment device in a cross-section of a lumen.  
         [0058]      FIG. 52  illustrates  FIG. 51  with a portion of the toggle deployment device shown in section E-E.  
         [0059]      FIGS. 53-55  illustrate a method of using the toggle deployment device in a cross-section of a lumen.  
         [0060]      FIG. 56  is a close-up view of  FIG. 55 .  
         [0061]      FIG. 57  illustrates an embodiment of a deployed toggle in a cross-section of a lumen.  
         [0062]      FIG. 58  is a close-up view of  FIG. 59 .  
         [0063]      FIGS. 59-61  illustrate a method for deploying a toggle in a cross-section of a lumen.  
         [0064]      FIG. 62  is a close-up view of  FIG. 61 .  
         [0065]      FIG. 63  illustrates a method for deploying a toggle in a cross-section of a lumen.  
         [0066]      FIGS. 64-66  shown, in cross-section, a method for deploying the guidewire through an arteriotomy.  
         [0067]      FIGS. 67 and 68  illustrate a method for attaching guidewire to the anchor.  
     
    
     DETAILED DESCRIPTION  
       [0068]      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 .  
         [0069]     The anchor  6  can have an anchor angle section  12 . The anchor  6  can have an anchor extension section  14 , for example a guide eye sheath or an attachable guidewire. The anchor extension section  14  can extend from the anchor angle section  12 . The anchor extension section  14  can be separate from and attached to, or integral with, the anchor angle section  12 .  
         [0070]     The anchor angle section  12  can have an anchor angle first sub-section  16 , an anchor bend  20  and an anchor angle second sub-section  18 . The anchor angle first and/or second sub-sections  16  and/or  18  can be part of the anchor bend  20 . The anchor bend  20  can have a sharp or gradual curve. The radius of curvature for the anchor bend  20  can be from about 0.1 mm (0.004 in.) to about 2.0 mm (0.079 in.).  
         [0071]     The anchor angle first sub-section  16  can have an anchor angle first sub-section 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.).  
         [0072]     The anchor angle first sub-section  16  can have a delivery longitudinal axis  26 . The anchor angle second sub-section  18  can have an anchor longitudinal axis  28 . The intersection of the delivery longitudinal axis  26  and the anchor longitudinal axis  28  can be an anchoring angle  30 . The anchoring angle  30  can be from about 20° to about 90°, more narrowly from about 30° to about 60°, for example about 45°.  
         [0073]     Any or all elements of the arteriotomy device  2  or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, polytefrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold.  
         [0074]     Any or all elements of the arteriotomy device  2 , including supplemental closure devices, such as tensioners, clips, toggles, sutures, or other devices or apparatuses described herein can be or have a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, 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.  
         [0075]     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 &amp; 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 E 2  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.  
         [0076]      FIG. 4  illustrates that the anchor angle section  12  and the anchor extension section  14  can have a flexible elongated element. The flexible elongated element can be resilient and/or deformable. The flexible elongated element can have an integral, or multiple separate and fixedly attached, wound wire  32 . The anchor angle section  12  can be in a sheath  34 .  FIG. 5  illustrates that the anchor angle section  12  can have a wire coating  36 , for example a lubricious coating and/or a coating made from urethane.  
         [0077]      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.  
         [0078]     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 01°.  
         [0079]     The introduction device  38  can have an introduction device diameter  44 . The introduction device diameter  44  can be from about 0.25 mm (0.010 in.) to about 1.0 mm (0.039 in.), for example about 0.56 mm (0.022 in.).  
         [0080]      FIGS. 8 and 9  illustrate that the arteriotomy device  2  can be configured so that the introduction device  38  can be deployed from the anchor  6 . The anchor  6  can have an introduction device port  46 . The introduction device  38  can be a hollow needle (as shown in  FIG. 8 ). When fully deployed, the introduction device  38  can contact the introducer lumen exit port  10 . The introduction device  38  can be a channel between the introducer lumen  8  and the anchor  6 . The anchor  6  can have a port (not shown) configured to communicate with the biological lumen and the introduction device  38 . The introduction device  38  can be a solid needle (as shown in  FIG. 9 ).  
         [0081]      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 .  
         [0082]      FIGS. 11 and 12  illustrate that the lumenal retainer  48  can have a second deployed configuration.  FIG. 11  shows that the lumenal retainer  48  can be a wire or balloon.  FIG. 12  shows that the lumenal retainer  48  can be a wire. In the deployed configuration, the lumenal retainer  48  can deploy away from the lumenal retainer port. The lumenal retainer  48  can have a lumenal retainer deployed diameter  52 . The lumenal retainer deployed diameter  52  can be from about 2.54 mm (0.100 in.) to about 10.2 mm (0.400 in.), for example about 6.35 mm (0.250 in.).  
         [0083]      FIG. 13  illustrates that the arteriotomy device  2  can have an entry wall retainer port  54 . The entry wall retainer port  54  can be at or near the anchor bend  20 . The entry wall retainer port  54  can be at or near the anchor angle first sub-section  16 . The entry wall retainer port  54  can be in fluid communication with a sensor or port (not shown) on or near the delivery guide  4  of the arteriotomy device  2 .  
         [0084]      FIG. 14  illustrates that an entry wall retainer  56  can be deployed through the entry wall retainer port  54 . The entry wall retainer  56  can have a first retracted configuration (as shown in  FIG. 13 ). The entry wall retainer  56  can have a second deployed configuration (as shown in  FIG. 14 ).  
         [0085]      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 homograft, heterografts or combinations thereof. The supplemental closure devices can be made from autografts, allografts or combinations thereof.  
         [0086]      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.  
         [0087]     The tensioner legs  68  and  70  can have tensioner leg diameters  76 . The tensioner leg diameters  76  can be from about 0.1 mm (0.005 in.) to about 0.76 mm (0.030 in.), for example about 0.38 mm (0.015 in.). The tensioner first and second legs  68  and  70  can have a tensioner inter-leg outer diameter  78 . The tensioner inter-leg outer diameter  78  can be from about 1.3 mm (0.050 in.) to about 5.08 mm (0.200 in.), for example about 4.06 mm (0.160 in.). The tensioner shoulders  64  and/or  66  and/or the tensioner feet  72  and/or  74  can extend to a greater radius from the tensioner longitudinal axis  60  than their respective tensioner inter-leg radius.  
         [0088]      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 .  
         [0089]      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 .  
         [0090]      FIG. 18  illustrates the pressure clip  84  that can have a pressure clip sheath  98  slidably attached to the pressure clip second leg  92 . The pressure clip first and/or second ends  94  and/or  96  can be pressure dissipaters, such as flat and/or curved portions, for example circular loops. The pressure clip first and/or second ends  94  and/or  96  can be resilient and/or deformable. The pressure clip first leg  90  can be rotatably attached to the pressure clip second leg  92 . The pressure clip first leg  90  can be attached to the pressure clip second leg  92  via a rotatable, and/or deformable, and/or flexural joint in the pressure clip head  88 .  
         [0091]      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.  
         [0092]      FIG. 20  illustrates the toggle  100  that can have the filament  106  that can be slidably attached to the toggle second end  104  at a hole  108 . The filament  106  can frictionally fit the hole  108 . The filament  106  can have no pawls  110  (not shown in  FIG. 20 ). The filament  106  can interference fit the hole  108 . The filament  106  can have one or more pawls  110 . The hole  108  can have one or more notches  112 . The notches  112  can be internal to the hole  108 . The notches  112  and the pawls  110  can be configured to allow the toggle second end  104  to slide toward the toggle first end  102 . The notches  112  and the pawls  110  can be configured to provide an interference fit when the toggle second end  104  is attempted to be moved away from the toggle first end  102 .  
         [0000]     Method of Manufacture  
         [0093]     The elements of the arteriotomy device  2 , including the supplemental closure devices, can be directly attached by, for example, melting, screwing, gluing, welding or use of an interference fit or pressure fit such as crimping, snapping, or combining methods thereof. The elements can be integrated, for example, molding, die cutting, laser cutting, electrical discharge machining (EDM) or stamping from a single piece or material. Any other methods can be used as known to those having ordinary skill in the art.  
         [0094]     Integrated parts can be made from preformed resilient materials, for example resilient alloys (e.g., Nitinol, ELGILOY® that are preformed and biased into the post-deployment shape and then compressed into the deployment shape as known to those having ordinary skill in the art.  
         [0095]     Any elements of the arteriotomy device  2 , including the supplemental closure devices, or the arteriotomy device  2 , including the supplemental closure devices, as a whole after assembly, can be coated by dip-coating, brush-coating or spray-coating methods known to one having ordinary skill in the art. For example, these methods can be used to coat the wound wire  32  with the wire coating  36  can be spray coated, dip-coated or brushed onto the wire  32 .  
         [0096]     One example of a method used to coat a medical device for vascular use is provided in U.S. Pat. No. 6,358,556 by Ding et al. and hereby incorporated by reference in its entirety. Time release coating methods known to one having ordinary skill in the art can also be used to delay the release of an agent in the coating, for example the coatings on the supplemental closure devices.  
         [0097]     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.  
         [0000]     Method of Use  
         [0098]      FIG. 21  illustrates a method of inserting the anchor  6  into a biological lumen  114 , for example a blood vessel, such as a femoral artery. The biological lumen  114  can have a lumen wall  116  and a lumen wall surface  118 . The anchor  6  can be inserted into the biological lumen  114  using a Seldinger technique, modified Seldinger technique, or other method known to one having ordinary skill in the art. The anchor  6  can create a first arteriotomy  120 . The anchor  6  can be inserted into the lumen  114  so that the anchor angle second sub-section  18  can be substantially parallel with the lumen wall surface  118 . The anchor  6  can be inserted into the lumen  114  so that the anchor angle second sub-section  18  can be substantially in contact with the lumen wall surface  118 .  
         [0099]      FIG. 22  illustrates a method of deploying, as shown by arrow, the lumenal retainer  48  from the first retracted configuration to the second deployed configuration. The lumenal retainer  48  can be deployed by extending a wire, scaffold or stent, or by inflating a balloon. When the lumenal retainer  48  is deployed, the anchor angle second sub-section  18  can be made substantially parallel with the lumen wall surface  118 . When the lumenal retainer  48  is deployed, the anchor angle second sub-section  18  can be made to be substantially in contact with the lumen wall surface  118 .  
         [0100]      FIG. 23  illustrates a method of deploying, as shown by arrow  122 , the entry wall retainer  56  from the first retracted configuration to the second deployed configuration. When the lumenal retainer is in the second deployed configuration, the lumenal retainer  48  can be substantially parallel with the lumen wall surface  118 . When the lumenal retainer is in the second deployed configuration, the lumenal retainer  48  can be substantially in contact with the lumen wall surface  118 .  
         [0101]     A proximal force, as shown by arrow  124 , can be applied to the anchor  6 , for example by being applied to the delivery guide  4 . When the proximal force is applied, the anchor angle second sub-section  18  can be made substantially parallel with the lumen wall surface  118 . When the proximal force is applied, the anchor angle second sub-section  18  can be made to be substantially in contact with the lumen wall surface  118 .  
         [0102]      FIGS. 24 and 25  illustrate a method for deploying the introduction device  38 . The introduction device  38  can egress from the introducer lumen  8  and the introducer lumen exit port  10 . As shown in  FIG. 24 , the introduction device  38  can be pushed, as shown by arrow, into and through the lumen wall  116 . The introduction device  38  can form a second arteriotomy  128 . As shown in  FIG. 25 , the introduction device  38  can be pushed, as shown by arrow, adjacent to or through the anchor  6 . The anchor  6  can be configured to have ports suitable to allow the introduction device  38  to pass through the anchor  6 . A tip of the introduction device  38  can enter the lumen  114 .  
         [0103]     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.).  
         [0104]     The introduction rise  134  can be the component of the length of the introduction device  38  in the lumen wall  116  that is perpendicular to the lumen wall  116 . The introduction rise  134  can be the component of the length perpendicular 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 rise  134  can be from about 0.51 mm (0.020 in.) to about 5.08 mm (0.200 in.), for example about 1.0 mm (0.040 in.). An introduction slope can be the ratio of the introduction rise  134  to the introduction run  132 . The introduction slope can be from about ½ to about 1/40 or less, for example about ⅙, also for example about ⅓. The introduction slope can be, for examples, equal to or less than about ½ or ⅓, more narrowly equal to or less than about ⅓ or ¼, yet more narrowly equal to or less than about ⅕ or ⅙, even still more narrowly than about equal to or less than about 1/10.  
         [0105]     The introduction rise  134  and the introduction run  132  can be components of an introduction vector. The introduction run  132  can be the component of the introduction vector parallel to the lumen wall  116 . The introduction rise  134  can be the component of the introduction vector perpendicular to the lumen wall  116 . The introduction vector can be a vector from an outer opening  136  to an inner opening  138 . The outer opening  136  can be a temporary or permanent opening on the outside of the lumen wall  116  formed by the introduction device  38 . The inner opening  138  can be a temporary or permanent opening on the inside of the vessel wall.  
         [0106]      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 example 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 .  
         [0107]      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°.  
         [0108]     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 .  
         [0109]     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.  
         [0110]     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.  
         [0111]     The introducer sheath can be inserted into the second arteriotomy  128 . The introducer sheath can expand the second arteriotomy  128  to a workable size. The introducer sheath can be inserted into the second arteriotomy  128  before and/or after and/or concurrently with the supplemental closure device is deployed and/or other closure method is used.  
         [0112]      FIGS. 32 and 33  illustrate an exemplary biological lumen  114  after the arteriotomy device  2  has been deployed to, and removed from, the biological lumen  114 . The biological lumen  114  can have the first and second arteriotomies  120  and  128 . The biological lumen  114  can have a second arteriotomy  128 . The biological lumen  114  can have a first web  140  on one side of the arteriotomy (shown for the second arteriotomy  128 ), and a second web  142  on the opposite side of the arteriotomy  120  or  128 . The natural pressure, shown by arrows, from the first and second webs  140  and  142  can self-seal the arteriotomy  120  or  128 .  
         [0113]     One or more supplemental closure devices can be deployed to the first and/or second arteriotomies  120  and/or  128 . The supplemental closure devices can provide a force or restraint to aid hemostasis. The supple mental closure devices can be permanently or temporarily deployed. The supplemental closure devices can biodissolve after hemostasis is achieved and/or after the relevant arteriotomy  120  or  128  is substantially or completely healed. The force from the supplemental closure device can be maintained from about 15 minutes to about 24 hours or more, for example about 120 minutes.  
         [0114]      FIG. 34  illustrates a tensioner  58  in a compressed configuration. Compressive forces, shown by arrows, can compress the tensioner first and second legs  68  and  70 . In a compressed configuration, the tensioner inter-leg outer diameter  78  can be from about 0.51 mm (0.020 in.) to about 2.54 mm (0.100 in.), for example about 1.5 mm (0.060 in.).  
         [0115]      FIGS. 35 and 36  illustrate a 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 .  
         [0116]     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 .  
         [0117]     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.  
         [0118]     The arteriotomy  120  or  128  can have an arteriotomy width  150  and an arteriotomy height  152 . The arteriotomy width  150  can be about half the circumference of the arteriotomy  120  or  128 . The arteriotomy width  150  can be from about 1.0 mm (0.040 in.) to about 10.2 mm (0.400 in.), for example about 4.06 mm (0.160 in.).  
         [0119]     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 (0.0.15 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 .  
         [0120]     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 feet  72  and  74  can be wide enough to interference fit with the arteriotomy  120  or  128 . The tensioner first and second feet  72  and  74  can dissipate force on the lumen wall surface  118 .  
         [0121]     The arteriotomy  120  or  128  can be plugged, and/or packed, and/or tamponed before, and/or concurrent with, and/or after using any of any of the supplemental closure devices infra and/or supra, the self-sealing closure method, or combinations thereof. The plug, pack, tampon, or combinations thereof (not shown) can be made from gelfoam, collagen, other implantable and biocompatible tampon materials known to those having ordinary skill in the art, or combinations thereof.  
         [0122]      FIGS. 37 through 40  illustrate deploying the pressure clip  84  to the arteriotomy  120  or  128 .  FIG. 37  illustrates extending, and/or thinning, and/or straightening, and/or tensioning 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 onto the pressure clip second end  96 . The pressure clip  84  can be deployed to the arteriotomy after the pressure clip second end  96  is extended, and/or thinned, and/or straightened, and/or tensioned.  
         [0123]     As shown in  FIG. 38 , the pressure clip second leg  92  can be rotated with respect to the pressure clip head  88 , so that the pressure clip second leg  92  and the pressure clip head  88  are substantially aligned. The pressure clip second leg  92  can be deployed, as shown by the arrow, through the first arteriotomy  120 . The pressure clip second leg  92  can be deployed through the lumen wall  116  (e.g., if there is no existing first arteriotomy  120 , if the first arteriotomy  120  is not suitably located with respect to the second arteriotomy  128 ).  
         [0124]      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.  
         [0125]     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.  
         [0126]      FIGS. 41 and 42  illustrate a method of deploying a stitch  154  surrounding and/or through the arteriotomy  120  or  128 . The stitch  154  can be tightened to apply additional pressure to the arteriotomy  120  or  128 . The stitch  154  can have a knot  156 , or other tying configuration or device, for example a pledget or clamp.  
         [0127]      FIGS. 43 and 44  illustrate a method of deploying the filament.  106  adjacent to and/or through the arteriotomy  120  or  128 . The filament  106  can be attached to a first pledget  158   a  by a first knot  156   a  or other tying configuration or device. The filament  106  can be attached to a second pledget  158   b  by a second knot  156   b  or other tying configuration or device. The first and second pledgets  158   a  and  158   b  can be other pressure diffusers known to one having ordinary skill in the art, such as the toggles  100  described infra and supra.  
         [0128]      FIGS. 45 and 46  illustrate a toggle deployment device  159  that can be in a first retracted configuration. The toggle deployment device  159  can have a pressure check port  160 . The pressure check port  160  can be in fluid communication with a sensor or port on or near the handle (not shown) of the toggle deployment device  159 , such as an external lumen where blood flow can be observed, for example from flow from the end of an external tube or port and/or through a transparent or translucent window. The pressure check port  160  can facilitate deployment of the toggle deployment device  159  to a location where the pressure check port  160  is introduced to pressure, for example when the pressure check port  160  enters the biological lumen  114 . The sensor or port on or near the handle of the toggle deployment device  159  will signal that the pressure check port  160  has been placed into the biological lumen  114  (e.g., by displaying a small amount of blood flow). The pressure check port  160  can be deployed into the biological lumen  114  and then withdrawn from the biological lumen  114  to the point where the lumen wall  116  just stops the pressure in the pressure check port  160 . The entry wall retainer port  54  can additionally perform the function as described herein for the pressure check port  160 . The toggle deployment device  159  can have a delivery needle port  161 .  
         [0129]      FIGS. 47 and 48  illustrate the toggle deployment device  159  that can be in a second delivery configuration. A delivery needle  162  can be slidably attached to the toggle deployment device  159 . The delivery needle  162  can egress from the delivery needle port  161  when the toggle deployment device  159  is in the second delivery configuration.  
         [0130]      FIGS. 49 and 50  illustrate that the toggle deployment device  159  can be deployed into the arteriotomy  120  or  128  at a location where the pressure check port  160  can be located in the biological lumen  114 . The delivery needle port  161  can be in, or adjacent to, the lumen wall  116 .  
         [0131]      FIGS. 51 and 52  illustrate that the toggle deployment device  159  can be placed in the second delivery configuration. 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 .  
         [0132]      FIG. 53  illustrates that a pusher  164  can be slidably attached to the delivery needle  162 . The delivery needle  162  can have a needle tip port  166 . The toggle  100  can be in the delivery needle  162 . The toggle  100  can be configured in the delivery needle  162  such that the toggle first end  102  can be located on the needle tip port  166  side of the pusher  164 .  
         [0133]      FIG. 54  illustrates that the pusher  164  can be moved, as shown by arrow, toward the needle tip port  166 . The delivery needle  162  can be moved back relative to the pusher  164 , the pusher  164  can be moved forward relative to the delivery needle  162 , or combinations thereof. The pusher  164  can push the toggle first end  102  out of the delivery needle  162 . The pusher  164  can push the toggle first end  102  into the biological lumen  114 .  
         [0134]      FIGS. 55 and 56  illustrate that the toggle deployment device  159  can be in a first retracted configuration after deploying the toggle first end  102  into the biological lumen  114 . When the delivery needle  162  retracts into the toggle deployment device  159 , the toggle second end  104  can be in the toggle deployment device  159 . The filament  106  can extend though the delivery needle port  161 .  
         [0135]      FIGS. 57 and 58  illustrate that the toggle  100  can be deployed across the lumen wall. When the toggle deployment device  159  is removed from the arteriotomy, the toggle second end  104  can deploy on the outside of the lumen wall  1 . 16  from the delivery needle port  161 . The toggle first end  102  can form an interference fit with the lumen wall surface  118 . The toggle second end  104  can form an interference fit with the outside of the lumen wall  116  or the surrounding tissue, such as subcutaneous tissue. The toggle second end  104  can be slidably translated along the filament  106  toward the lumen wall  116 , for example for the toggle  100  illustrated in  FIG. 20 . 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.  
         [0136]      FIGS. 59 through 63  illustrate a method for deploying the toggle  100 . The delivery needle  162  can egress, as shown by arrow, from a toggle deployment delivery port  163 . The toggle deployment delivery port  163  can be in the delivery guide  4 . The delivery needle  162  can be advanced toward the lumen  114 .  
         [0137]      FIG. 60  illustrates that the delivery needle  162  can be deployed through the lumen wall. When the delivery needle  162  is deployed through the lumen wall  116 , the delivery needle can intersect, or pass adjacent to, the second arteriotomy.  
         [0138]      FIGS. 61 and 62  illustrate that the pusher  164  can be advanced, as shown by arrow, through the delivery needle  162 . The toggle first end  102  can egress from the needle tip port  166 . The toggle first end  102  can deploy into the lumen  114 .  
         [0139]      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.  
         [0140]      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 .  
         [0141]      FIG. 66  illustrates that the introducer needle  165  can be removed, as shown by arrow, from the lumen wall  116 . The guidewire  168  can remain substantially in place. After the introducer needle  165  is removed, a portion of the guidewire  168  can be outside the lumen  114  and another portion of the guidewire  168  can be inside the lumen  114 .  
         [0142]      FIG. 67  illustrates a method of fixedly or slidably attaching the guidewire  168  to the anchor  6 . A guidewire proximal end  170  can be placed in proximity to an anchor distal end  172 . The guidewire proximal end  170  can then be attached, as shown by arrows, to the anchor distal end  172 . The guidewire proximal end  170  can be attached to the anchor distal end  172  while some or all of the guidewire  168  is in the lumen  114 . The guidewire proximal end  170  can be configured to snap-fit, interference fit, slidably attach or combinations thereof, to the anchor  6 . When the guidewire  168  is attached to the anchor  6 , the guidewire  168  can act as the anchor extension section  14  and/or the lumenal tool.  FIG. 68  illustrates the guidewire  168  attached to the anchor  6 .  
         [0143]     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.

Technology Classification (CPC): 0