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 both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel&#39;s intima and adventitia. Methods for using the device are also disclosed.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application 60/680,388 filed May 12, 2005, the content of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to the field of accessing a biological lumen and closing the access port thereby created. 
     2. Description of the Related Art 
     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. 
     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. 
     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. 
     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. 
     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. 
     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. 
     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 is self-sealing and secure. 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 
     A method for accessing a biological lumen having a lumen wall and surrounding tissue is disclosed. The method includes forming a path between the lumen wall and the surrounding tissue. The method further includes extending the path through the lumen wall. The method also includes opening the path to the lumen. 
     The method of forming the path can include inserting a device between the lumen wall and the surrounding tissue. Extending the path can include inserting the device through the lumen wall. Opening the path can include inserting the device into the lumen. The method can include delivering a filler into the path. 
     The method can include filling the path. Filling the path can include delivering a filler into the path. The filler can have a solid-setting liquid. The filler can have an epoxy. 
     The method can include applying pressure to the path. Applying pressure to the path can include delivering filler adjacent to the path. Delivering filler adjacent to the path can include delivering filler between the lumen wall and the surrounding tissue. Delivering filler can include delivering filler in the lumen wall. Delivering filler can include delivering filler in the surrounding tissue. 
     Also disclosed is a method for forming an arteriotomy in a lumen having a lumen wall and surrounding tissue. The method includes translating a device substantially between the lumen wall and the surrounding tissue. The method further includes turning the device toward the lumen. The method also includes translating the device through the lumen wall. The method also includes removing the device from the lumen wall. 
     The surrounding tissue can have adventitia. Turning can include relaxation of a preformed configuration in the device. 
     The method can also include translating a guide through the device. Translating a guide can include translating the guide into the lumen. The method can also include translating a guide into the lumen. Translating a guide can include translating the guide through the device. 
     An access device for accessing a biological lumen is disclosed. The device has an introduction device having a relaxed configuration. The relaxed configuration has a first flat section, a first bend at an end of the first flat section, and a first slope extending at a first end from the first bend. The introduction device is configured to be translated with respect to the access device. 
     The relaxed configuration of the introduction device can have a second bend at a second end of the first slope, a second flat section extending at a first end from the second bend, a third bend at a second end of the second flat section, and a second slope extending from the third bend. The access device can have a delivery guide. The delivery guide can be configured to deliver the introduction device. 
     The access device can have an anchor. The anchor can extend from the delivery guide. The anchor can be configured to stabilize the access device with respect to the lumen. 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an embodiment of a method of using the arteriotomy device in a cross-section of a lumen. 
         FIGS. 2 through 5  illustrate a method of using the arteriotomy device in a cross-section of a lumen. 
         FIG. 6  illustrates a portion of an arteriotomized lumen. 
         FIGS. 7 through 11  illustrate various embodiments of section A-A of  FIG. 6 . 
         FIG. 12  illustrates an embodiment of the arteriotomy device in a first configuration. 
         FIG. 13  is a close-up view of an embodiment of section B of  FIG. 12 . 
         FIG. 14  illustrates an embodiment of the arteriotomy device of  FIG. 12  in a second configuration. 
         FIG. 15  is a close-up view of an embodiment of section C of  FIG. 14 . 
         FIG. 16  illustrates an embodiment of the arteriotomy device of  FIG. 12  in a third configuration. 
         FIG. 17  is a close-up view of an embodiment of section D of  FIG. 16 . 
         FIG. 18  illustrates an embodiment of the arteriotomy device of  FIG. 12  in a fourth configuration. 
         FIG. 19  is a close-up view of an embodiment of section E of  FIG. 18 . 
         FIG. 20  illustrates an embodiment of the arteriotomy device of  FIG. 12  in a fourth configuration. 
         FIGS. 21 and 22  are close-up views of various embodiments of section F of  FIG. 20 . 
         FIG. 23  illustrates an embodiment of the arteriotomy device. 
         FIG. 24  illustrates an embodiment of the arteriotomy device of  FIG. 12  in a fifth configuration. 
         FIG. 25  is a close-up view of an embodiment of section G of  FIG. 24 . 
         FIG. 26  illustrates an embodiment of the arteriotomy device. 
         FIG. 27  is a close-up view of an embodiment of section H of  FIG. 26 . 
         FIGS. 28 through 32  illustrate various embodiments of cross-section I-I of  FIG. 27 . 
         FIGS. 33 and 34  are a perspective and side view, respectively, of an embodiment of section H of  FIG. 26 . 
         FIG. 35  illustrates an embodiment of a method of using the arteriotomy device in a cross-section of a lumen. 
         FIG. 36  is a close-up view of an embodiment of section J of  FIG. 35 . 
         FIG. 37  illustrates an embodiment of a method of using an embodiment of the arteriotomy device of  FIG. 35  in a cross-section of a lumen. 
         FIG. 38  is a close-up view of an embodiment of section K of  FIG. 37 . 
         FIGS. 39 and 40  illustrate various methods of using the arteriotomy device. 
         FIGS. 41 and 42  illustrate sectional views of an embodiment of the delivery guide. 
         FIGS. 43 through 48  illustrate various embodiments of the introduction device. 
         FIGS. 49 and 50  are various embodiments of cross-section K-K of  FIG. 48 . 
         FIGS. 51 through 53  illustrate various embodiments of the introduction device. 
         FIGS. 54 and 55  illustrate various embodiments of the introduction device in relaxed configurations. 
     
    
    
     DETAILED DESCRIPTION 
     U.S. patent application Ser. No. 10/844,247, filed 12 May 2004, is incorporated by reference herein in its entirety. Aspects, characteristics, components or complete embodiments of devices and methods disclosed therein can be used with anything disclosed herein. 
       FIGS. 1 through 6  illustrate embodiments of an arteriotomy device  2 , and methods for accessing (e.g., percutaneously) a biological lumen  4  and deploying an introduction device  6  that can have one or more pre-formed bends. The biological lumen  4  can be surrounded by a lumen wall  8  (e.g., intima and/or media). The lumen wall  8  can be surrounded by surrounding tissue  10  (e.g., media and/or adventitia). 
     The arteriotomy device  2  can have a delivery guide  12 . The delivery guide  12  can be slidably attached to an anchor  14 . The anchor  14  can be rigid, flexible or combinations thereof. The anchor  14  can be resilient, deformable or combinations thereof. The anchor  14  can be retractable and extendable from the delivery guide  12 . The anchor  14  can have a guide eye sheath or an attachable guidewire. The anchor  14  can have an integral, or multiple separate and fixedly attached, wound wire. The anchor  14  can have a wire coating, for example a lubricious coating and/or a coating made from urethane 
     The anchor  14  can have an anchor longitudinal axis  16 . The introduction device can have an introduction longitudinal axis  18 . The intersection of the anchor longitudinal axis  16  and the introduction longitudinal axis  18  can be an introduction angle  20 . The anchor  14  can be inserted into the biological lumen  4  using a Seldinger technique, modified Seldinger technique, or other method known to one having ordinary skill in the art. 
     The arteriotomy device  2  can be configured to deliver the introduction device at the introduction angle  20 . The introduction device  6  can have an introduction longitudinal axis. The introduction angle  20  can be the intersection of the introduction longitudinal axis  18  and the anchor longitudinal axis  16 . The introduction angle  20  can have an absolute value from about 0° to about 30°, more narrowly from about 0° to about 19°, yet more narrowly from about 0° to about 15°, yet more narrowly from about 5° to about 10°, for example about 10°. 
     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 Oct. 9, 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.), carbon fiber composites (e.g., carbon fiber nylon composite, such as carbon fiber reinforced nylon 66), polypropylene, polytetrafluoroethylene (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. 
     Any or all elements of the arteriotomy device  2 , including supplemental closure devices, such as filler, 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. 
     The elements of the arteriotomy device  2  and/or the filler 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; niefenamic 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. 
     The delivery guide  12  can be deployed through the surrounding tissue  10  and into the lumen wall  8  and/or the lumen  4 . As illustrated in FIGS. 45 and 46 of U.S. patent application Ser. No. 10/844,247 for a toggle deployment device, the arteriotomy device  2  can have a pressure check port. The pressure check port can be in fluid communication with a sensor or port on or near the handle of the arteriotomy device  2 , 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 can facilitate deployment of the arteriotomy device  2  to a location where the pressure check port is introduced to pressure, for example when the pressure check port enters the biological lumen  4 . The sensor or port on or near the handle of the arteriotomy device  2  will signal that the pressure check port has been placed into the biological lumen  4  (e.g., by displaying a small amount of blood flow). The pressure check port can be deployed into the biological lumen  4  and then withdrawn from the biological lumen  4  to the point where the lumen wall  8  just stops the pressure in the pressure check port. An entry wall retainer port can additionally perform the function as described herein for the pressure check port. 
     The delivery guide  12  can form a first arteriotomy  22 . When the anchor  14  is properly located in the lumen  4 , a luminal retainer  24  and/or an entry wall retainer  26  can be deployed from the anchor  14  and/or the delivery guide  12 . The anchor  14 , and/or luminal retainer  24 , and/or entry wall retainer  26  can be wires, rods, inflatable balloons, or combinations thereof. The anchor  14 , and/or luminal retainer  24 , and/or entry wall retainer  26  can be separate, integral or a single component. 
     When the anchor  14  is properly located in the lumen  4 , the introduction device  6  can be translated, as shown by arrow. The introduction device can form a second arteriotomy  28 . The introduction device  6  can create a cleavage  30  between the lumen wall  8  and the surrounding tissue  10 . The introduction device  6  can cleave a plane in the lumen wall  8 , as shown in  FIG. 2 . The cleavage  30  and/or cleavage plane can be substantially parallel with a lumen wall surface  32 . The introduction device  6  can be adjacent to the adventitia in a blood vessel. The introduction device  6  can be advanced along the subintimal or submedial cleavage plane in a blood vessel. 
     Once the lumen wall  8 , and/or the surrounding tissue  10 , and/or the cleavage  30  has been cleaved, a subintimal angioplasty can be performed as known to one having ordinary skill in the art. Once the lumen wall  8 , and/or the surrounding tissue  10 , and/or the cleavage  30  has been cleaved, a remote endarterectomy can be performed as known to one having ordinary skill in the art. 
     The introduction device  6  can have one or more straights and/or bends. Various bent introduction devices  34  and straight introduction devices  36  can be swapped during use to selectively cleave the lumen wall  8  and/or the surrounding tissue  10  and/or the cleavage  30 . Tools, such as guides (e.g., guidewires), can be inserted through hollow introduction devices  6  to selectively cleave. 
     As shown in  FIG. 3 , when a bend  34  in the introduction device  6  moves into the lumen wall  8 , the introduction device  6  can rotate and slope, as shown by arrow, toward the biological lumen  4 . The bend  34  in the introduction device  6  can continue to rotate the introduction device  6  toward the biological lumen  4 . When the introduction device  6  is sloping, the introduction angle  20  can be from about 0° to about 120°, more narrowly from about 5° to about 45°, yet more narrowly from about 10° to about 30°, for example about 15°. 
       FIG. 4  illustrates that the introduction device  6  can be further translated, as shown by arrow. The introduction device  6  can enter the lumen  4 . 
     The introduction device  6  can pass through an introduction run  38  and an introduction rise  40 . The introduction run  38  can be the component of the length of the introduction device  6  in the lumen wall  8  that is parallel to the lumen wall  8 . The introduction run  38  can be the component of the length parallel to the lumen wall  8  between the opening of the second arteriotomy  28  on the outside of the lumen wall  8  and the opening of the second arteriotomy  28  on the inside lumen wall surface  32 . The introduction run  38  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.). 
     The introduction rise  40  can be the component of the length of the introduction device  6  in the lumen wall  8  that is perpendicular to the lumen wall  8 . The introduction rise  40  can be the component of the length perpendicular to the lumen wall  8  between the opening of the second arteriotomy  28  on the outside of the lumen wall  8  and the opening of the second arteriotomy  28  on the inside lumen wall surface  32 . The introduction rise  40  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  40  to the introduction run  38 . 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. 
     The introduction rise  40  and the introduction run  38  can be components of an introduction vector. The introduction run  38  can be the component of the introduction vector parallel to the lumen wall  8 . The introduction rise  40  can be the component of the introduction vector perpendicular to the lumen wall  8 . The introduction vector can be a vector from an outer opening  42  to an inner opening  44 . The outer opening  42  can be a temporary or permanent opening in the lumen wall  8  or in the surrounding tissue  10  formed by the initial translation of the introduction device  6  out of the delivery guide  12 . The inner opening  44  can be a temporary or permanent opening on the lumen wall surface  32 . 
       FIG. 5  illustrates that the introduction device  6  can act as a pathway for a luminal tool, for example a guidewire  46 . 
     An introducer sheath (not shown) can be inserted over the guidewire  46  and/or over or through the introduction device  6 . 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. 
     The introducer sheath can be inserted into the second arteriotomy  28 . The introducer sheath can expand the second arteriotomy  28  to a desired or workable size. The introducer sheath can be inserted into the second arteriotomy  28  before and/or after and/or concurrently with when the filler, described infra, is deployed and/or other closure methods or devices are used. 
       FIGS. 6 and 7  illustrate an exemplary biological lumen  4  after the arteriotomy device  2  has been deployed to, and removed from, the biological lumen  4 . The biological lumen  4  can have the second arteriotomy  28 . The biological lumen  4  can have a first web  48  on one side of the second arteriotomy  28 , and a second web  50  on the opposite side of the second arteriotomy  28 . The blood pressure  52 , shown by arrows, on the first and second webs  48  and  50  can self-seal the second arteriotomy  28 . 
     The second arteriotomy  28  can have an arteriotomy cross-section that can have an arteriotomy diameter  54 . The arteriotomy diameter  54  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.). The arteriotomy diameter  54  can be about the diameter of the introduction device  6 . 
     The arteriotomy cross-section can be non-circular. The arteriotomy can have an arteriotomy width and an arteriotomy height. The arteriotomy width can be about half the circumference of the arteriotomy. The arteriotomy width 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.). 
     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 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 diameter, and/or height, and/or width can be small enough to enable cell growth, blood clotting, acoustic sealing, heat sealing, gluing, enhanced self-sealing and combinations thereof across the second arteriotomy  28 . 
     The delivery guide  12  and/or other components of the arteriotomy device  2  can form a delivery path  56  during use. During percutaneous use, the delivery path can extend to the skin  138 . 
     The second arteriotomy  28  can have a flat  58  and a slope  60 . The flat  58  can be the cleavage  30  between the lumen wall  8  and the surrounding tissue. 
       FIG. 8  illustrates that the second arteriotomy  28  can have a first flat  58 , a first slope  64 , a second flat  66 , and a second slope  68 . The second arteriotomy  28  having multiple flats and slopes can be made from one or more introduction devices  6  that can have various geometries. 
       FIG. 9  illustrates that the second arteriotomy  28 , for example in the flat  58  and/or the slope  60 , can be filled with a filler  70 . The filler  70  can be a solid single component, multiple solid components (e.g., beads), a biocompatible epoxy, or combinations thereof. The filler  70  can be completely or partially bioabsorbable, bioresorbable, bioadsorbable or combinations thereof. The filler  70  can be made from homografts, heterografts or combinations thereof. The filler  70  can be made from autografts, allografts or combinations thereof. 
     The filler  70  can be delivered (e.g., injected and/or implanted) into the second arteriotomy  28  through the surrounding tissue  10 , for example by percutaneous injection. The filler  70  can be delivered (e.g., injected and/or implanted) into the second arteriotomy  28  through the second arteriotomy  28 , for example via the introduction device  6  during introduction and/or removal of the introduction device  6 . 
     The filler  70  can be permanently or temporarily deployed. The filler  70  can biodissolve after hemostasis is achieved and/or after the arteriotomy is substantially or completely healed. The filler  70  can be maintained from about 15 minutes to about 24 hours or more, for example about 120 minutes. 
       FIG. 10  illustrates that the filler can be in the cleavage  30 , not in the second arteriotomy  28 . The filler  70  can exert a filler pressure  72  on the second arteriotomy  28 , for example on the flat  58  and/or slope  60 . The second arteriotomy  28  can be compressed by the blood pressure  52  and the filler pressure  72 . 
       FIG. 11  illustrates that the filler can be in the in the cleavage  30 , not in the second arteriotomy  28 . The filler  70  can exert filler pressure  72  against the second flat  66  and/or first slope  64  and/or other sections of the second arteriotomy  28 . 
     The filler  70  can be between the second arteriotomy  28  and the lumen  4  (not shown). The filler  70  can be in the surrounding tissue  10 . 
       FIGS. 12 and 13  illustrate the arteriotomy device  2 . The arteriotomy device  2  can have a handle  74  that can be integral with or fixedly attached to a delivery guide extension  76 . The delivery guide extension  76  can be integral with or fixedly attached to the delivery guide  12 . The anchor  14  can extend from, and be slidably and/or fixedly attached to or integral with, the delivery guide  12 . 
     The anchor  14  can have an anchor first length  78  extending from the delivery guide  12 . The anchor  14  can have an anchor first bend  80  at the end of the first anchor length  78  distal to the delivery guide  12 . An anchor second length  82  can extend at a first end from the anchor first bend  80 . A second end of the anchor second length  82  can have an anchor second bend  84 . An anchor third length  86  can extend from the anchor second bend  84 . The anchor third length  86  can terminate. The anchor  14  can have any combination of lengths and bends. 
     The radius of curvature for the anchor bends  80  and  84  can be from about 0.1 mm (0.004 in.) to about 2.0 mm (0.079 in.). The anchor lengths on both sides of any anchor bend can form an anchoring angle. The anchoring angles can be from about 90° to about 160°, more narrowly from about 120° to about 150°, for example about 135°. The anchor  14  can have a cross-section having an anchor diameter 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 third length  86  can have an anchor tip  88 . The anchor tip  88  can be narrowed, widened, sharpened, dulled, or otherwise configured to promote sharp or blunt dissection. The anchor tip  88  can have an anchor end port  90 . The anchor end port  90  can be in communication with an anchor guidewire lumen (not shown). The anchor guidewire lumen can be in communication with a guide lumen  92  in the delivery guide extension  76 , and/or the handle  74 , and/or a third control  94 . The guide lumen  92  can have open access along the delivery guide extension  76 , and/or along the handle  74 , and/or along the third control  94  (as shown). 
     The handle  74  can have a first control  96 . The first control  96  can be slidably attached to a control slide  98 . The first control  96  can be configured to be ergonomically receptive to be activated a digit and/or a palm. 
     The handle  74  can have a second control  100 . The second control  100  can be rotatably attached to the handle  74 , for example at a control pivot  102 . The second control  100  can have a tab  104 . The tab  104  can be configured to be ergonomically receptive to be activated by a digit and/or a palm. 
     The handle  74  can have a third control  94 . The third control can be slidably attached to the handle  74 . The third control  94  can have or be a plunger. The third control  94  can have a press  106 . The press  106  can be configured to be ergonomically receptive to be activated by a digit and/or a palm. The handle  74  can have one or more grips  108 . The grips  108  can be configured to be ergonomically receptive to be held by a digit and/or a palm. 
     The configuration of any of the first, second or third controls  96 ,  100  and  94  can be any configuration (e.g., the first control can have the rotatable lever of the second control  100 ). 
     A guidewire  46  can be in proximity to the anchor tip  88 . 
       FIGS. 14 and 15  illustrate that the guidewire  46  can be inserted into the anchor end port  90 , as shown by arrows. The guidewire  46  can be fed through the anchor guidewire lumen and the guide lumen  92 . The guidewire  46  can exit through the open section of the guide lumen  92 . 
     The guidewire  46  can be used to deploy the arteriotomy device to a desired location in a lumen. The arteriotomy device  2  can be translated, for example percutaneously, over and along the guidewire  46 . If the guidewire  46  is in a lumen, the arteriotomy device  2  can be translated along the guidewire  46 , for example, until blood appears at the pressure check port. 
       FIG. 16  illustrates that the first control  96  can be activated, as shown by arrow. The first control  96  can be translated along the control slide  98 . Activating the first control  96  can translatably and/or rotatably deploy the luminal retainer  24 , as shown by arrow in  FIG. 17 . 
     The luminal retainer  24  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 luminal retainer  24  can extend into the delivery guide  12 . 
       FIG. 17  illustrates that the luminal retainer  24  can be deployed, as shown by arrow, for example due to the activation of the first control  96 . The luminal retainer  24  can have a first stressed configuration. The luminal retainer  24  can have a second relaxed configuration. The luminal retainer  24  can be in a relaxed of a stressed configuration prior to deployment. The luminal retainer  24  can be in a relaxed or a stressed configuration after deployment. The relaxed configuration of the luminal retainer  24  can be the deployed configuration of the luminal retainer  24 . 
     The luminal retainer  24  can be configured to press against the lumen  4  during use. The luminal retainer can be deployed by translating, rotating or a combination thereof, with respect to the anchor  14 . 
     The luminal retainer  24  can deploy from the anchor  14 . The luminal retainer  24  can deploy from a luminal retainer port (not shown). The luminal retainer  24  can have a luminal retainer deployed diameter. The luminal retainer deployed diameter 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.). 
       FIG. 18  illustrates that the second control  100  can be activated, as shown by arrow. The second control  100  can be rotated around the control pivot  102 . Activating the second control can translatably and/or rotatably retract the anchor  14 , as shown by arrows in  FIG. 19 . 
       FIG. 19  illustrates that the anchor  14  can translate both parallel and/or perpendicular to the delivery guide  12 . 
     The anchor first length  78  can have an anchor shift  110  or small inflection. The anchor shift  110  can be configured wherein the anchor first length  78  shifts perpendicular to the longitudinal axis of the delivery guide  12 , as seen in  FIG. 19 . An introduction lumen exit port  112  can be covered by the anchor first length  78 , for example, before the anchor is retracted into the delivery guide  12 . 
     When the anchor is retracted into the delivery guide  12 , an introduction lumen exit port  112  can be exposed. When the anchor is retracted into the delivery guide  12 , the anchor shift  110 , laterally positioned compared to the rest of the anchor first length  78 , can expose the introduction lumen exit port  112 . When the anchor is retracted into the delivery guide  12 , the anchor shift  110 , laterally positioned compared to the rest of the anchor first length  78 , can force the entire anchor  14  to move laterally, thereby exposing the introduction lumen exit port  112 . 
       FIG. 20  illustrates that the third control  94  can be activated, as shown by arrow. The third control  94  can be translated with respect to the handle  74 . Activating the third control can translatably deploy the introduction device  6 , as shown by arrow in  FIG. 21 . 
     The introduction device  6  can have an introduction device diameter. The introduction device diameter 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.). 
     The arteriotomy device  2  can be configured to deploy the introduction device  6  from the anchor  14  and/or the delivery guide  12  (as shown). The anchor  14  and/or delivery guide  12  can have the introduction lumen exit port  112 . The introduction device  6  can deploy through the introduction lumen exit port  112 . The introduction device  6  can be a solid or hollow needle, or combinations thereof. 
       FIG. 22  illustrates that the distance perpendicular to the introduction device  6  between the introduction lumen exit port  112  to the anchor first length  78  can be substantially and/or completely equal to the introduction rise  40 . The anchor  14  can have one or more radiopaque marks. For example, the anchor first length  78  can have a first radiopaque mark  114 . The first radiopaque mark  114  can be significantly longer along the anchor first length  78  than the first radiopaque mark  114  is tall or wide. The delivery guide  12  can have a second radiopaque mark  116 . The second radiopaque mark  116  can be parallel and aligned with the path of the introduction device  6  where the introduction device  6  exits the introduction lumen exit port  112 . The user can view a radiograph or to assist in the placement of the arteriotomy device  2 . 
       FIG. 23  illustrates that the arteriotomy device can have a first, second and third radiopaque marks  114 ,  116  and  118 . The first radiopaque mark  114  can be on the handle. The second radiopaque mark  116  can be on the delivery guide extension  76 . The third radiopaque mark  118  can be on the anchor  14 . A straight alignment axis  120  can pass through the first, second and third radiopaque marks  114 ,  116  and  118 . The user can utilize the alignment axis  120  to assist in the placement of the arteriotomy device  2 , for example while viewing a radiograph. 
     The radiopaque marks can be marks for any type of medical imagining. For example, the marks could be sono-opaque and/or sono-reflective for use with sonographs. 
       FIG. 24  illustrates that the third control  94  can be activated further, for example, by continuing to translate the third control  94  toward the handle  74 , as shown by arrow. Activating or re-activating the third control can translatably deploy the introduction device  6 , as shown by arrow in  FIG. 25 . 
     The introduction device  6  can have a bend  34 . The bend  34  can be in a relaxed configuration of the introduction device  6 . If the introduction device  6  is deployed far enough, the bend  34  can rotate the introduction device  6  toward the lumen  4 . 
     The first, second and third controls  96 ,  100  and  94  can have lockouts to prevent the controls  96 ,  100  and  94  from being activated incorrectly (e.g., to prevent use in the wrong order). 
       FIG. 26  illustrates that the luminal retainer  24  can form a circular, oval, or spiral configuration.  FIG. 27  illustrates that the anchor  14  can have a luminal retainer exit port  122 . 
       FIGS. 28 through 32  illustrate various configurations of the luminal retainer  24  in the anchor  14  prior to deployment.  FIG. 28  illustrates that one end of the luminal retainer can be fixedly or rotatably attached to the anchor  14 . The luminal retainer  24  can have a ball  124  and the anchor  14  can have a socket  126 . The ball  124  can have an interference fit in the socket  126 . When the deployment force is applied, shown by arrow, the luminal retainer  24  can relax, if pre-stressed (e.g., heat-treated to a specific shape), and/or be forced into buckling out through the luminal retainer exit port  122 . 
       FIG. 29  illustrates that the luminal retainer  24  can be loaded in a loop or spiral configuration in the anchor  14 . When the deployment force is applied, as shown by arrow, the loop  128  will naturally expand and exit the luminal retainer port  122 . 
       FIG. 30  illustrates that the luminal retainer can be pre-formed with a curvature  130 . When the deployment force is applied, shown by arrow, the luminal retainer  24  can relax, if pre-stressed (e.g., heat-treated to a specific shape), and/or be forced into buckling into the anchor  14  across from the luminal retainer exit port  122 . The luminal retainer  24  can then buckle and/or twist at the weakest point along the length, for example the curvature  130 . The luminal retainer  24  can then exit through the luminal retainer exit port  122 . 
       FIG. 31  illustrates that the luminal retainer  24  can be fixed to the anchor  14 , for example at a fixation area  132  (e.g., via welding, gluing, snap fitting, etc.).  FIG. 32  illustrates that the embodiments of the luminal retainer can be reversed in direction with respect to the remainder of the arteriotomy device  2 . 
       FIGS. 33 and 34  illustrate that the luminal retainer  24  can deploy as the loop or spiral. The luminal retainer  24  can deploy out of the luminal retainer exit port  122  on the anchor (as shown) and/or the delivery guide  12 . 
       FIGS. 35 and 36  illustrate that arteriotomy device  2  can be translated deep enough into the lumen  4  to contact the deployed luminal retainer  24  against the lumen wall  8  opposite from the arteriotomy  134 .  FIGS. 37 and 38  illustrate that the handle  74  can be translated, as shown by arrow in  FIG. 37 , away from the lumen  4 . The luminal retainer  24  can be translated, as shown by arrow in  FIG. 38 , into the lumen wall  8  closest to the arteriotomy  134 . The luminal retainer  24  can abut the lumen wall  8 , for example, acting as the entry wall retainer  26 . The delivery guide extension  76  can be rotatably attached to the delivery guide  12 , for example by a hinge  136 . 
       FIG. 39  illustrates that the handle  74  and the delivery guide extension  76  can rotate around the hinge, as shown by arrows, with respect to the delivery guide  12 , the anchor  14  and the luminal retainer  24 . Rotated configurations of the handle  74  and the delivery guide extension are shown in phantom lines. The handle  74  and delivery guide extension  76  can be manipulated during use with a minimal impact on the delivery guide  12 , the anchor  14  and the luminal retainer  24 . 
       FIG. 40  illustrates that the delivery guide extension can be flexible. The handle  74  and the delivery guide extension  76  can rotate around the flexible delivery guide extension  76 , as shown by arrows, with respect to the delivery guide  12 , the anchor  14  and the luminal retainer  24 . Rotated configurations of the handle  74  and the delivery guide extension are shown in phantom lines. 
       FIG. 41  illustrates a first longitudinal section  140  of the delivery guide  12 .  FIG. 42  illustrates a second longitudinal section  142  of the delivery guide  12 . The first longitudinal section  140  can be a complete or substantial mirror image of the second longitudinal section  142 . 
     An extension attachment  144  can be configured to fixedly attach to the delivery guide extension  76 . The extension abutment  146  can be configured to abut against and/or fixedly attach to the delivery guide extension  76 . The extension attachment  144  and/or extension abutment  146  can form fluid-tight and/or air-tight seals with the delivery guide extension  76 . 
     The anchor lumen  148  can be configured to receive and deploy the anchor  14  out the anchor exit port  150 . The introducer lumen  152  can be configured to receive and deploy the introduction device  6  out the introduction lumen exit port  112 . The relative geometries of the anchor lumen  148 , the introducer lumen  152 , the anchor exit port  150 , and the introduction lumen exit port  112  can be changed to alter the introduction angle  20 , introduction run  38 , introduction rise  40 , and the geometry of the arteriotomy  134  including the geometries of the slopes  60  and flats  58  of the arteriotomy  134 . 
     The delivery guide half attachments  154  can attach the first longitudinal section  140  to the second longitudinal section  142 , for example by rotatably attaching to a screw. The seam surfaces  156  of the first longitudinal section  140  can form fluid-tight and/or air-tight seals with the seam surfaces  156  of the second longitudinal section  142 . The delivery guide tip  158  can be sharpened, dulled, or otherwise configured to aid sharp or blunt dissection. 
       FIGS. 43 through 46  illustrate solid introduction devices  6  that can each have an introduction device shaft  160  that can terminate in an introduction device tip  162 . As shown in  FIG. 43 , the introduction device tip  162  can have a centered needle point. The introduction device tip  162  can have an introduction device tip cross-section  164 . The introduction device tip cross-section  164  can be circular or square or combinations thereof. The introduction device tip can be curved (not shown). 
       FIG. 44  illustrates that the introduction device tip  162  can have an off-center needle point. The introduction device tip cross-section  164  can be circular or square or combinations thereof. The introduction device  6  can be configured to have a flat side along the introduction device shaft  160  and along the introduction device tip  162 . 
       FIG. 45  illustrates that the introduction device tip  162  can have a centered chisel point. The introduction device tip cross-section  164  can be oval, rectangular, elliptical, or a combination thereof. 
       FIG. 46  illustrates that the introduction device tip  162  can have a off-centered chisel point. The introduction device tip cross-section  164  can be oval, rectangular, elliptical, or a combination thereof. The introduction device  6  can be configured to have a flat side along the introduction device shaft  160  and along the introduction device tip  162 . 
       FIGS. 47 through 53  illustrate hollow introduction devices  6  that can each have an introduction device shaft  160  that can terminate in an introduction device tip  162 . The introduction device shaft  160  can have a hollow guide lumen  92  than can extend to the introduction device tip  162  or to the side of the introduction device shaft  160 . The guide lumen  92  can terminate at a guide port  166 . A guide (e.g., a guidewire or other tool) can be slidably attached to the introduction device  6  in the guide lumen  92 . The guide lumen can have a guide shaft  168  that can terminate in a guide tip  170 . The guide  172  can exit the introduction device at the guide port  166 . 
     As shown in  FIG. 47 , the introduction device tip  162  can be a centered hollow needle point. The guide tip  170  can be a centered needle point. The guide tip  170  can be aligned with the introduction device tip to form a substantially smooth combined tip. 
     As shown in  FIG. 48 , the introduction device tip  162  can be an off-center hollow needle point. The guide tip  170  can be a centered needle point. 
       FIG. 49  illustrates that the guide shaft  168  can have a key  174  and/or a slot  176  (not shown). The introduction device shaft  160  can have a slot  176  and/or a key  174  (not shown). The key  174  on the guide shaft  168  can slidably attach to the slot  176  in the introduction device shaft  160 . The slidable attachment of the key  174  and slot  176  can prevent the guide shaft  168  from rotating about a longitudinal axis with respect to the introduction device shaft  160 . 
       FIG. 50  illustrates that the guide lumen  92  and the guide shaft  168  can be oval. The oval configurations of the guide lumen  92  and the guide shaft  168  can prevent the guide shaft  168  from rotating about a longitudinal axis with respect to the introduction device shaft  160 . 
       FIG. 51  illustrates that the introduction device tip  162  can have a curved end  178 . The curved end  178  can be configured to fit into a recess  180  in the guide  172 . The recess  180  can have a hook  182 . The curved end  178  can have a notch  184 . The hook  182  can interference fit and/or snap fit the notch  184 . 
       FIG. 52  illustrates that the guide lumen  92  can be curved. The guide lumen  92  can terminate at a guide port  166  in the side of the introduction device shaft  160 . 
       FIG. 53  illustrates that the introduction device tip  162  and/or the introduction device shaft (not shown) can be curved. The guide  172  or lengths of the guide  172  can be curved in a relaxed configuration. The guide  172  or lengths of the guide  172  can be curved in a stressed configuration due to the curvature of the introduction device  6 . 
     Any of the introduction devices  6  shown in  FIG. 43  through  FIG. 46  can be hollowed and configured identically or similar to the introduction devices illustrated in  FIG. 47  through  FIG. 53 . Any of the introduction devices  6  shown in  FIG. 47  through  FIG. 53  can have no guide lumen and be configured identically or similar to the introduction devices illustrated in  FIG. 43  through  FIG. 46 . 
     The guides  172  and/or guide lumens  92  and/or introduction devices  6  can have a lubricious coating or be impregnated to elute a lubricious material. 
       FIG. 54  illustrates that the introduction device  6  can have a relaxed configuration having a flat  58  that can have a bend  34  at one end. A slope can extend from the bend  34 . The relaxed configuration of the introduction device  6  can form the arteriotomy configuration, for example, as shown in  FIGS. 7 and 9 , during deployment of the introduction device  6  from the delivery guide  12 . 
       FIG. 55  illustrates that the introduction device  6  can have a relaxed configuration having a first flat  62  that can have a first bend  186  at one end. A first slope  64  can extend at a first end from the first bend  186 . The first slope  64  can have at a second end a second bend  188 . A second flat  66  can extend at a first end from the second bend  188 . The second flat  66  can have at a second end a third bend  190 . A second slope  68  can extend from the third bend  190 . The relaxed configuration of the introduction device  6  can form the arteriotomy configuration, for example, as shown in  FIGS. 8 ,  10  and  11 , during deployment of the introduction device  6  from the delivery guide  12 . 
     The introduction device  6 , for example a hollow introduction device  6 , can act as a pathway for a luminal tool, for example tools such as a guidewire  46 , to be deployed into the lumen  4 . The introduction device  6 , for example a solid introduction device  6 , can be removed from the second arteriotomy  28  and the luminal tool can be deployed through, for example, the introduction lumen exit port  112 , and the second arteriotomy  28 . The introduction device  6 , or part thereof, can be the luminal tool, for example the guide  172 . The introduction device  6  can be further deployed and used as a luminal tool after passing through the lumen wall  8 . 
     The guide  172  can remain substantially in place after the arteriotomy device  2  is removed. A portion of the guide  172  can be outside the lumen  4  and another portion of the guide  172  can be inside the lumen  4 . The guide proximal end can then be attached to additional devices and implants to guide the devices and implants into the lumen. The filler  70  can be added after additional procedures are completed and the guide  172  is removed, or before the guide  172  is removed, using the guide  172  to redeploy the arteriotomy device  2  back to the arteriotomy  134  to deliver the filler  70 . 
     Method of Manufacture 
     The elements of the arteriotomy device  2 , and those of any other devices and components disclosed herein, 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. 
     Integrated parts can be made from pre-formed 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. 
     Any elements of the arteriotomy device  2 , and those of any other devices and components disclosed herein, 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. 
     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. 
     Any elements herein 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. 
     As shown in  FIGS. 13 ,  41  and  42 , the delivery guide  12  can be fixedly composited, for example with a weld, unitary construction (e.g., by casting), snap fitting components, a screw  192 , or combinations thereof. The screw  192  can attach the delivery guide  12  to the delivery guide extension  76 , for example by screwing through the delivery guide and/or by squeezing the delivery guide onto the delivery guide extension. 
     The radiopaque marks can be attached to the elements and/or coated on the surface of the elements and/or manufactured integrally in the elements. 
     The introduction device  6 , guide  172 , anchor  14 , luminal retainer  24 , entry wall retainer  26 , any other elements, or combinations thereof can be heat set in a relaxed configuration using methods know to those having ordinary skill in the art. 
     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