1 AUSTRALIA Patents Act 1990 ARSTASIS, INC. COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Biological tissue closure device and method The following statement is a full description of this invention including the best method of performing it known to us:- 1 TITLE OF THE INVENTION 2 3 BIOLOGICAL TISSUE CLOSURE DEVICE AND METHOD 4 5 BACKGROUND OF THE INVENTION 6 [00011 The present invention relates to the field of closing openings in biological tissue 7 and methods of performing the same. 8 [0002] A number of diagnostic and interventional vascular procedures are now 9 performed translumenally, where a catheter is introduced to the vascular system at a 10 convenient access location - such as the femoral, brachial, or subclavian arteries - and 11 guided through the vascular system to a target location to perform therapy or diagnosis. 12 When vascular access is no longer required, the catheter and other vascular access 13 devices must be removed from the vascular entrance and bleeding at the puncture site 14 must be stopped. 15 [00031 One common approach for providing hemostasis is to apply external force near 16 and upstream from the puncture site, typically by manual compression. This method is 17 time-consuming, frequently requiring one-half hour or more of compression before 18 hemostasis. This procedure is uncomfortable for the patient and frequently requires 19 administering analgesics. Excessive pressure can also present the risk of total occlusion 20 of the blood vessel, resulting in ischemia and/or thrombosis. 21 [0004] After hemostasis is achieved by manual compression, the patient is required to 22 remain recumbent for six to eighteen hours under observation to assure continued 23 hemostasis. During this time bleeding from the vascular access wound can restart, 1 potentially resulting in major complications. These complications may require blood. 2 transfusion and/or surgical intervention. 3 [00051 Bioabsorbable fasteners have also been used to stop bleeding. Generally, these 4 approaches rely on the placement of a thrombogenic and bioabsorbable material, such as 5 collagen, at the superficial arterial wall over the puncture site. This method generally 6 presents difficulty locating the interface of the overlying tissue and the adventitial surface 7 of the blood vessel. Implanting the fastener too far from the desired location can result in 8 failure to provide hemostasis. If, however, the fastener intrudes into the vascular lumen, 9 thrombus can form on the fastener. Thrombus can embolize downstream and/or block 10 normal blood flow at the thrombus site. Implanted fasteners can also cause infection and 11 auto-immune reactions/rejections of the implant 12 [0006] Suturing methods are also used to provide hemostasis after vascular access. The 13 suture-applying device is introduced through the tissue tract with a distal end of the 14 device located at the vascular puncture. Needles in the device draw suture through the 15 blood vessel wall on opposite sides of the punctures, and the suture is secured directly 16 over the adventitial surface of the blood vessel wall to close the vascular access wound. 17 [00071 To be successful, suturing methods need to be performed with a precise control. 18 The needles need to be properly directed through the blood vessel wall so that the suture 19 is well anchored in tissue to provide for tight closure. Suturing methods also require 20 additional steps for the surgeon. 21 100081 In U.S. Patent No. 6,56,136 to Weng et al., a hemostatic seal is attempted by the 22 use of high intensity forced ultrasound (HIFU). In commercialized devices utilizing 23 acoustic energy to create hemostasis seals, an acoustic transducer is held near an 2 1 arteriotomy, and acoustic energy is transmitted to the target location to heat-seal the 2 opening. All other surgical devices are removed from the arteriotomy before application 3 of the acoustic energy. Due to the lack of definite aiming of the acoustic transducer at the 4 arteriotomy, the acoustic energy from the transducer can fail to seal the target 5 arteriotomy, and/or can unintentionally effect surrounding tissue. In addition, the 6 arteriotomy is in the approximate shape of a cylinder, increasing the possibility that walls 7 of the arteriotomy will be too far apart to seal together during energy application. 8 [00091 Due to the deficiencies of the above methods and devices, a need exists for a more 9 reliable vascular closure method and device. There also exists a need for a vascular 10 closure device and method that does not implant a foreign substance and is self-sealing. 11 There also exists a need for a vascular closure device and method requiring no or few 12 extra steps to close the vascular site. Furthermore, there exists a need for a vascular 13 closure device using energy to create a hemostatic seal, where the energy is precisely 14 aimed at the vascular site. Additionally, there exists a need for a vascular closure device 15 using energy to create a hemostatic seal for a vascular opening, where the walls of the 16 vascular opening are brought together before application of the energy. 17 18 BRIEF SUMMARY OF THE INVENTION 19 [0010] A device for closing an opening in biological tissue is disclosed. The device has a 20 tensioner and a seal applier. The tensioner is configured to tension the opening. The 21 tensioner can have a first elongated member and a second elongated member. The first. 22 elongated member can be configured to bias away from the second elongated member. 3 I The second elongated member is configured to bias away from the first elongated 2 member. 3 [0011] The seal applier can have an RF transducer, an acoustic (e.g., ultrasound) 4 transducer, a resistive heater, a microwave heater, an inductive heater, a hole (e.g., a 5 microscopic pore), a web, or combinations thereof. The web can have a first fiber and a 6 second fiber. The first fiber can cross the second fiber. The web can be made from a 7 bioabsorbable material. The web can be removably attached to the device. 8 [0012] Furthermore, a vascular closure device is disclosed. The vascular closure device 9 uses energy to create a hemostatic seal. The device is configured to deliver energy to an 10 arteriotomy. The device is configured to precisely aim the energy at the arteriotomy. 11 10013] A device for closing an opening in biological tissue is also disclosed. The 12 opening has an internal wall. The device has a wall manipulator, and a seal applier. The 13 wall manipulator is configured to bring a first part of the wall adjacent to a second part of 14 the wall. 15 [00141 A method for closing an opening in a biological tissue is disclosed. The opening 16 has an internal wall. The method includes tensioning the opening and applying a sealer 17 to the opening. Tensioning the opening can include bringing a first part of the wall 18 adjacent to a second part of the wall. The first part of the wall can be brought to less than 19 about 0.51 mm away from the second part of the wall. The first part of the wall can be 20 brought to less than about 0.38 mm away from the second part of the wall. The first part 21 of the wall can be brought to more than about 0.25 mm away from the second part of the 22 wall. The sealer can include energy, such as acoustic energy (e.g., ultrasound), RF 23 energy, conductive heat energy, a liquid adhesive, or combinations thereof. 4 1 [0015] The method can also include aiming the sealer at the opening. Aiming can 2 include deploying an aiming device into the opening. The aiming device can be on or 3 adjacent to the skin surface. The method can also include deploying a web into the 4 opening. The method can also include leaving the web in the opening at least until the 5 web is entirely bioabsorbed. 6 [0016] Also disclosed is a method for closing an opening in a biological tissue. The 7 opening has an internal wall. The method includes bringing a first part of the wall 8 adjacent to a second part of the wall and applying a sealer to the opening. 9 10 BRIEF DESCRIPTION OF THE DRAWINGS 11 100171 Figure 1 illustrates an embodiment of the distal end of the closure device. 12 [0018] Figure 2 illustrates a close-up view of Figure 1 centered around the second 13 expander wire. 14 [00191 Figures 3-6 illustrate various embodiments of the distal end of the closure device. 15 [0020] Figure 7 illustrates an embodiment of the distal end of the closure device in a 16 retracted configuration. 17 [0021] Figures 8 and 9 are see-through views of an embodiment of the closure device in 18 a retracted configuration. 19 [00221 Figure 10 is a see-through view of an embodiment of the closure device in a 20 retracted configuration. 21 [0023] Figures 11 through 13 illustrate a method of changing an embodiment of the 22 closure device from a retracted configuration to an extended configuration. 5 1 [0024] Figure 14 illustrates a close-up view of the distal end of the closure device of 2 Figure 11. 3 [00251 Figure 15 illustrates a close-up view of the distal end of the closure device of 4 Figure 13. 5 [0026] Figures 16 and 17 illustrate a method for deploying the expander wires into an 6 arteriotomy in a see-through portion of the lumen wall. 7 [0027] Figure 18 illustrates a distant view of the method for deploying the expander 8 wires into an arteriotomy in a see-through portion of the lumen wall of Figure 17. 9 100281 Figures 19 through 22 illustrate close-up views of various embodiments for 10 methods of using the closure device in an arteriotomy in a see-through portion of the 11 lumen wall. 12 10029] Figure 23 illustrates a cut-away view of an embodiment for a method of using the 13 closure device with an external transducer. 14 100301 Figure 24 illustrates a cut-away perspective view of the embodiment of Figure 23. 15 16 DETAILED DESCRIPTION 17 [00311 Figure 1 illustrates in an extended (i.e., expanded) configuration, a closure device 18 2 for biological tissue closure, for example to create hemostasis across an arteriotomy. 19 Figure 2 illustrates a close-up of the distal end of the closure device of Figure 1. 20 [0032] The closure device 2 can have a delivery guide 4. The delivery guide 4 can be a 21 tubular member, such as a catheter or sheath on the outer radial side of the closure device 22 2. The delivery guide 4 can be hollow. In one configuration, the delivery guide 4 can be 23 on the proximal end of the closure device 2. In another configuration, the delivery guide 6 1 4 can be the entire length of the closure device 2. The delivery guide 4 can have a low 2 friction inner surface. The delivery guide 4 can be configured to receive an inner 3 member 6. The delivery guide 4 can have a distal port 8 at the distal end of the delivery 4 guide 4. 5 [0033] The delivery guide 4 can have a proximally-located handle (not shown). The 6 handle can facilitate manipulation of the delivery guide 4 and the inner member 6, and 7 operation of the closure device 2. 8 [0034] The closure device 2 can have the inner member 6. The inner member 6 can be 9 configured to slidably or fixedly attach to the inside of the delivery guide 4. The inner 10 member 6 can have a member longitudinal axis 10. The distal port 8 of the delivery 11 guide 4 can be at a non-perpendicular angle with respect to the member longitudinal axis 12 10. 13 [0035] The inner member 6 can have a first wire port (not shown) and a second wire port 14 12b. The wire ports 12a and 12b can be channels along entire length (e.g., from the distal 15 end to the handle at the proximal end) of the member longitudinal axis 10. The wire 16 ports 12a and 12b can have an opening at or near the distal end of the inner member 6. 17 [00361 The inner member 6 can have a sealer channel (not shown). The sealer channel 18 can have an energy conduit and/or a fluid conduit. The sealer channel can be configured 19 to deliver energy (e.g., for tissue adhesion and/or for enhanced cell growth and/or 20 denaturing and recoagulation of the proteins, such as adventitial proteins and/or collagen) 21 and/or a liquid sealant (e.g., a hemostatic agent and/or tissue adhesive and/or volume 22 filler, such as polyethylene glycol (PEG)) to a sealer port 14 at a distal tip of the inner 7 1 member 6, and/or to one or more elongated members, such as first and/or second 2 expander wires 16a and/or 16b. 3 10037] A supplemental sealer delivery device 18 can be attached to the sealer port 14. A 4 natural seal can occur due to natural healing of the tissue of the arteriotomy from being in 5 proximity with itself. Supplemental sealing can be any sealing action in addition to the 6 natural seal, including methods to facilitate, maximize, and/or increase the efficiency of 7 the natural sealing. The supplemental sealer delivery device 18, or other delivery device, 8 can be configured to deliver a sealer, for example energy, such as acoustic or radio 9 frequency (RF) energy, microwave energy, and/or a biocompatible adhesive liquid. The 10 supplemental sealer delivery device 18 can be an acoustic transducer, such as a high 11 intensity focus ultrasound (HIFU) transducer or image-guided H1FU. The supplemental 12 sealer delivery device 18 can be from a loop extending from, and returning to, the sealer 13 port 14. The supplemental sealer delivery device 18 can be a spout (not shown) for 14 delivering-the liquid sealer. The supplemental sealer delivery device 18 can be a 15 combination of various individual supplemental sealer delivery devices 18 (e.g., an 16 acoustic transducer and a spout). 17 [00381 The first expander wire 16a and the second expander wire 16b can be slidably, 18 and/or rotatably, and/or fixedly attached to the first wire port 12a and second wire port 19 12b, respectively. The expander wires 16a and 16b can distally extend from the wire 20 ports 12a and 12b, respectively. The first and second expander wires 16a and 16b can 21 have first and second expander wire extensions 20a and 20b, respectively, and first and 22 second expander wire tips 22a and 22b, respectively. 8 1 [0039] As exemplarily shown on the second expander wire 16b in Figure 2, the expander 2 wire extensions 20a and 20b can extend radially away from the member longitudinal axis 3 10. First and second expander wire tips 22a and 22b can extend at angles from the first 4 and second expander wire extensions 20a and 20b, respectively. The first and second 5 expander wire tips 22a and 22b can have tip longitudinal axes 24a and 24b. The first and 6 second tip longitudinal axes 24a and 24b can be substantially parallel with the member 7 longitudinal axis 10. The distal ends of the first and second expander wire tips 22a and 8 22b can have first (not shown) and second feet 26b, respectively. The feet 26a and 26b 9 can extend radially further from the member longitudinal axis 10 than a main portion of 10 the expander wire tips 22a and 22b. 11 [0040] The expander wires 16a and 16b can have wire diameters 28. The wire diameters 12 28 can be transverse (i.e., about perpendicular) to the tip longitudinal axes 24a and 24b. 13 The wire diameters 28 can be from about 0.1 mm (0.005 in.) to about 1.2 mm (0.050 in.), 14 for example about 0.38 mm (0.015 in.). 15 [0041] The distance from about the member longitudinal axis 10 to about the radially 16 outer side of the expander wire tips 22a or 22b can be a sealing radius 30. The sealing 17 radius 30 can be from about 0.51 mm (0.020 in.) to about 5.08 mm (0.200 in.), for 18 example about 2.0 mm (0.080 in.). 19 100421 The expander wire tips 22a and 22b can have tip lengths 32. The tip lengths 32 20 can be from about 0.51 mm (0.020 in.) to about 25 mm (1.0 in.), for example about 4.06 21 mm (0.160 in.). 9 1 [0043] The expander wire extensions 20a and 20b can have extension lengths 34. The 2 extension lengths 34 can be from about 2.54 mm (0.100 in.) to about 25 mm (1.0 in.), for 3 example about 9.65 mm (0.380 in.). 4 [0044] Figure 3 illustrates the closure device 2 that can have the supplemental sealer 5 delivery device 18 that can extend from the sealer port 14. The supplemental sealer 6 delivery device 18 can extend along the member longitudinal axis 10 to about the same 7 distance as the distal ends of the first and/or second expander wires 16a and/or 16b are 8 located parallel to the member longitudinal axis 10. 9 [00451 The supplemental sealer delivery device 18 can be configured to transmit RF 10 energy. For example, the supplemental sealer delivery device 18 can be in electrical 11 communication with a conductive wire (e.g., from inside the inner member). The first 12 and/or second expander wires 16a and/or 16b can be configured to transmit RF energy. 13 For example, the first and/or second expander wires 16a and/or 16b can be in electrical 14 communication with a conductive wire (e.g., from inside the inner member 6). 15 [0046] The supplemental sealer delivery device 18 can be configured to transmit 16 microwave energy. For example, the supplemental sealer delivery device 18 can be in 17 electrical communication with a wave guide (e.g., from inside the inner member). The 18 first and/or second expander wires 16a and/or 16b can be configured to transmit 19 microwave energy. For example, the first and/or second expander wires 16a and/or 16b 20 can be in electrical communication with a wave guide (e.g., from inside the inner member 21 6). 22 [0047] Figure 4 illustrates the closure device 2 that can have no supplemental sealer 23 delivery device 18. The first and/or second expander wires 16a and/or 16b can be 10 1 configured to transmit one or more sealers, for example energy. The first and/or second 2 expander wires 16a and/or 16b can be attached to an acoustic energy actuator, for 3 example inside the inner member 6. The first and/or second expander wires 16a and/or 4 16b can be in electrical communication with a single conductive wire or conductive wires 5 for each expander wire 16a and 16b. 6 [00481 Figure 5 illustrates the closure device 2 that can have no supplemental sealer 7 delivery device 18. The first and/or second expander wires 16a and/or 16b can be 8 configured to transmit a physical sealer, for example a liquid adhesive sealant. The first 9 and/or second expander wires 16a and/or 16b can be hollow. The first and/or second 10 expander wires 16a and/or 16b can have delivery holes 36 (e.g., microscopic pores and/or 11 macroscopic openings) on the surface thereof, for example to delivery liquid adhesive 12 sealant, or any anti-biotic, anesthetic, vaso-restrictors, PEG, or any other agent listed 13 supra or combinations thereof. The delivery holes 36 can be on the first and/or second 14 expander wire tips 22a and/or 22b. The delivery holes 36 can be on the sides of the first 15 and/or second expander wires 16a and/or 16b facing the member longitudinal axis 10. 16 The delivery holes 36 can be arranged along a line, for example parallel to the member 17 longitudinal axis 10. The first and/or second expander wires 16a and/or 16b can be 18 attached, and in fluid communication, at a proximal end to a reservoir, and/or pump, 19 and/or valve holding and/or delivering a sealer, for example a liquid adhesive sealant. 20 [00491 Figure 6 illustrates the closure device 2 that can have a web 38 that can be 21 attached to the first and second expander wires 16a and 16b. The web 38 can be fixedly 22 or removably attached to the first and second expander wire tips 22a and 22b. The web 23 38 can be two or more crossed fibers or wires of material. The web 38 can be a mesh. 11 1 The web 38 can be a porous surface. The web 38 can be made from a metal, and/or a 2 conductive polymer. The web 38 can be made from a resorbable polymer. The web 38 3 can be configured to transmit RF energy, or can be inductively heated. For example, the 4 web 38 can be in electrical communication with a conductive wire (e.g., via the first 5 and/or second expander wire tip 22a and/or 22b from inside the inner member 6 and/or 6 from along the outside of the delivery guide 4 and/or from another tool not a part of the 7 closure device 2), and/or have current induced therein (e.g., from an external induction 8 coil). The web 38 can be in fluid communication with the delivery holes 36, as shown in 9 Figure 5. The fibers or wires of the web 38 can be hollow and/or have holes or pores (not 10 shown). The web 38 can be configured to transmit a physical sealer, for example a liquid 11 adhesive sealant. 12 [0050] Figure 7 illustrates the closure device 2 that can have a retracted (i.e., 13 compressed) configuration. The inner member 6 (not shown) can be retracted into the 14 delivery guide 4. The first expander wire 16a and/or the second expander wire 16b can 15 be retracted into the delivery guide 4. The distal ends of the first expander wire 16a 16 and/or the second expander wire 16b can be proximal to the distal port. 17 [00511 Figures 8 and 9 illustrate, in a retracted configuration, the closure device 2 that 18 can check for fluid pressure at the distal port 8. The closure device 2 can have a pressure 19 check port 40 in the delivery guide 4 and/or inner member 6 (not shown). The pressure 20 check port 40 can be distal to the expander wire tips 22a and 22b when the expander wire 21 tips 22a and 22b are in a retracted configuration. The pressure check port 40 can be in 22 fluid communication with the distal port 8 when the closure device 2 is in a retracted 23 position. The pressure check port 40 can be in fluid communication with an outer wall of 12 1 the delivery guide 4. The pressure check port 40 can be in fluid communication with a 2 pressure check lumen 42. The pressure check lumen 42 can be in fluid communication 3 with a sensor or port on or near the handle (not shown) of the delivery guide 4, such as an 4 external lumen where blood flow can be observed, for example flow from the end of an 5 external tube or port and/or through a transparent or translucent window. 6 [0052] Figure 10 illustrates, in a retracted configuration, the closure device 2 that can 7 have the pressure check port 40 aligned with the distal ends of the expander wire tips 22a 8 and 22b, for example, even with a distal alignment line 43. 9 [0053] When the closure device 2 is used, the distal end of the delivery guide 4 can be 10 inserted across the wall of a vessel until a "flash" of blood enters the pressure check port 11 40, flows up the pressure check lumen 42, and can then be observed by the sensor or port 12 on or near the handle. Once the blood "flash" is observed, the delivery guide 4 can be 13 moved slowly in the proximal direction until the "flash" stops. The "flash" stopping can 14 be an indication of the distal location of the delivery guide (i.e., the pressure check port 15 40 can be blocked by the lumen wall 54). 16 [0054] Any or all elements of the closure device 2 and/or other devices or apparatuses 17 described herein can be made from, for example, a single or multiple stainless steel 18 alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY@ from 19 Elgin Specialty Metals, Elgin, IL; CONICHROME@ from Carpenter Metals Corp., 20 Wyomissing, PA), molybdenum alloys (e.g., molybdenum TZM alloy, for example as 21 disclosed in International Pub. No. WO 03/082363 A2, published 9 October 2003, which 22 is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, 23 as disclosed in International Pub. No. WO 03/082363, polymers such as polyester (e.g., 13 1 DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, DE), 2 polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether 3 ether ketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g., PEBAX@ 4. from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX@ .5 from Thermedics Polymer Products, Wilmington, MA), polyvinyl chloride (PVC), 6 polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or 7 resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), 8 polydioxanone, and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, 9 zinc, echogenic, radioactive, radiopaque materials or combinations thereof. Examples of 10 radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel 11 titanium alloys, tantalum and gold. 12 [0055] Any or all elements 6f the closure device 2 and/or other devices or apparatuses 13 described herein ean be 6r have a matrix for cell ingrowth or used with a fabric, for 14 example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix 15 and/or fabric can-be, for example, polyester (e.g., DACRON@ from E. I. Du Pont de 16 Nemours and Company, Wilmington, DE), polypropylene, PTFE, ePTFE, nylon, 17 extruded collagen, silicone or combinations thereof. 18 [0056] The elements of the closure device 2 and/or other devices or apparatuses 19 described herein and/or the fabric can be filled and/or coated with an agent delivery 20 matrix known to one having ordinary skill in the art and/or a therapeutic and/or 21 diagnostic agent. The agents within these matrices can include radioactive materials; 22 radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic 23 agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, 14 1 and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti 2 inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as 3 cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® 4 from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL@ from Wyeth, 5 Collegeville, PA; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX@ 6 from Merck & Co., Inc., Whitehouse Station, NJ; CELEBREX@ from Pharmacia Corp., 7 Peapack, NJ; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus 8 (RAPAMUNE@, from Wyeth, , Collegeville, PA), or matrix metalloproteinase (MMP) 9 inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the 10 pathways of an inflammatory response. Examples of other agents are provided in Walton 11 et al, Inhibition of Prostoglandin E 2 Synthesis in Abdominal Aortic Aneurysms, 12 Circulation, July 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic 13 Inflammation Mediators and Chlamydia Pneumoniae, Brit. J Surgery 88 (7), 935-940; 14 Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on 15 Inflammation and Proteolysis, Brit. J Surgery 86 (6), 771-775; Xu et al, Spl Increases 16 Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological 17 Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix 18 Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal 19 Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all 20 incorporated by reference in their entireties. 21 22 METHOD OF MANUFACTURE 15 1 [0057] The elements of the closure device 2 can be directly attached by, for example, 2 melting, screwing, gluing, welding, soldering, abrasing, or use of an interference fit or 3 pressure fit such as crimping, snapping, or combining methods thereof. The elements can 4 be integrated, for example, molding, die cutting, laser cutting, electrical discharge 5 machining (EDM) or stamping from a single piece or material. Any other methods can 6 be used as known to those having ordinary skill in the art. 7 [00581 Integrated parts can be made from pre-formed resilient materials, for example 8 resilient alloys (e.g., Nitinol, ELGILOY@) that are preformed and biased into the post 9 deployment shape and then compressed into the deployment shape as known to those 10 having ordinary skill in the art. 11 [0059] The expander wires 16a and 16b can be made from pre-formed resilient materials, 12 for example resilient alloys (e.g., Nitinol, ELGILOY@) that are preformed and biased 13 into the post-deployment shape and then compressed into the deployment shape. The 14 post-deployment shape can be the configuration shown in Figure 2 and elsewhere herein. 15 [0060] Any elements of the closure device 2, or the closure device 2 as a whole after 16 assembly, can be coated by dip-coating, brush-coating or spray-coating methods known 17 to one having ordinary skill in the art. For example, the expander wires 16a and 16b can 18 be spray coated, dip-coated or brushed-coated. 19 [00611 One example of a method used to coat a medical device for vascular use is 20 provided in U.S. Patent No. 6,358,556 by Ding et al. and hereby incorporated by 21 reference in its entirety. Time release coating methods known to one having ordinary 22 skill in the art can also be used to delay the release of an agent in the coating, for example 23 the coatings on the expander wires 16a and 16b. 16 1 2 METHOD OF USE 3 [0062] Figures 11 through 13 illustrate a method for changing the closure device 2 from a 4 first configuration to a second configuration. Figures 14 and 15 also show close-up 5 views of distal ends of the closure device 2 of Figures 11 and 13, respectively. As shown 6 in Figures 11 and 14, the closure device 2 can be in a fully retracted configuration. The 7 inner member 6 and the expander wires 16a and 16b can be concealed within the delivery 8 guide 4. 9 [00631 As shown in Figure 12, the closure device 2 can be in a partially deployed 10 configuration. The inner member 6 can be pushed or pulled to be translated, as shown by 11 arrow 44, distally relative to the delivery guide 4, and/or the delivery guide 4 can be 12 pushed or pulled to be translated, as shown by arrow 46, proximally relative to the 13 delivery guide 4. 14 [0064] The delivery guide 4 can restrict (e.g., by interference fit) the expander wires 16a 15 and 16b from expanding away from the member longitudinal axis 10. The expander 16 wires 16a and 16b, can move distally, as shown by arrows 47, relative to the delivery 17 guide 4. The expander wires 16a and 16b can be attached to the inner member 6, such 18 that the inner member 6 pushes the expander wires 16a and 16b when the inner member 6 19 is pushed. 20 [00651 As shown in Figures 13 and 15, the closure device 2 can be in a fully deployed 21 configuration. The inner member 6 can be pushed or pulled to be translated, as shown by 22 arrow 48, distally relative to the delivery guide 4, until the inner member 6 reaches a stop 23 (not shown) with respect to the supplemental sealer delivery device. The stop can be an 17 1 interference fit between the delivery guide 4 and the inner member 6. The delivery guide 2 4 can be pushed or pulled to be translated, as shown by arrow 50, proximally relative to 3 the delivery guide 4, until the delivery guide 4 reaches the stop. 4 [0066] The expander wires 16a and 16b, can move distally, as shown by arrows 51, 5 relative to a location at which the expander wires 16a and 16b exit the wire ports 12a and 6 12b. The location at which the expander wires 16a and 16b exit the respective wire ports 7 12a and 12b can move beyond the distal port 8 and the delivery guide 4. The expander 8 wires 16a and 16b can expand radially, as shown by arrows 51, away from the member 9 longitudinal axis 10. 10 [0067] Figure 16 illustrates that the closure device 2 can be inserted, as shown by arrow, 11 into an opening in tissue, for example the arteriotomy 52 in a lumen wall 54. The closure 12 device 2 can be in the retracted configuration when the closure device 2 is inserted into 13 the arteriotomy 52. After inserting the closure device 2, the distal end of the closure 14 device 2 can be located in or outside and distal to the arteriotomy 52. The lumen wall 54 15 can have an inner lumen wall surface 56, and can surround a lumen 57. 16 [00681 The arteriotomy 52 can have an arteriotomy diameter 58. The arteriotomy 17 diameter 58 can be from about 0.5 mm (0.020 in.) to about 40 mm (1.5 in.), yet a 18 narrower range from about 1.0 mm (0.040 in.) to about 10.2 mm (0.400 in.), for example 19 about 2.54 mm (0.100 in.). When in the retracted configuration, the closure device 2 can 20 have a diameter smaller than the arteriotomy diameter 58. 21 [00691 The lumen wall 54 can have a lumen wall thickness 60. The lumen wall thickness 22 60 can be from about 0.51 mm (0.020 in.) to about 5.08 mm (0.200 in.), for example 23 about 1.0 mm (0.040 in.). 18 1 [0070] Figures 17 and 18 illustrate expanding the closure device 2 after the closure 2 device 2 has been inserted into the arteriotomy 52. The delivery guide 4 can be moved 3 proximally relative to the inner member 6. The expander wires 16a and 16b can expand, 4 as shown by arrows 62, away from the member longitudinal axis 10. The expander wire 5 tips 22a and 22b can be located inside the arteriotomy 52. The expander wire tips 22a 6 and 22b can expand, for example laterally, against the arteriotomy 52. The arteriotomy 7 52 can change shape in response to tensioning forces applied by the expander wire tips 8 22a and 22b, for example, during expansion. The feet 26a and 26b can pressure and/or 9 interference fit with the arteriotomy 52 and/or the inner lumen wall surface 56. 10 [0071] The arteriotomy 52 can have an arteriotomy width 64 and an arteriotomy height 11 66. The arteriotomy width 64 can be about half the circumference of the arteriotomy 52. 12 The arteriotomy width 64 can be from about 1.0 mm (0.040 in.) to about 10.2 mm (0.400 13 in.), for example about 4.06 mm (0.160 in.). 14 [0072] The arteriotomy height 66 can be about the wire diameter 28. The arteriotomy 15 height 66 can be less than about 0.51 mm (0.020 in.), more narrowly, less than about 0.38 16 mm (0.015 in.). The arteriotomy height 66 can be from about 0.1 mm (0.005 in.) to about 17 1.3 mm (0.050 in.), for example about 0.38 mm (0.015 in.). The arteriotomy height 66 18 can be small enough to enable cell growth, blood clotting, acoustic sealing, heat sealing, 19 gluing, enhanced self-sealing and combinations thereof across the arteriotomy 52. 20 [0073] Figure 19 illustrates a method for applying energy (e.g., acoustic) to the tensioned 21 arteriotomy 52. The closure device 2 can have the supplemental sealer delivery device 22 18. The supplemental sealer delivery device 18 can be an acoustic (e.g., ultrasound) 23 transducer. For example, because the expander wires 16a and 16b can produce opposite 19 I forces on opposite sides of the inside of the arteriotomy 52, the supplemental sealer 2 delivery device 18 can be automatically aimed and automatically centered (e.g., aligned 3 along the member longitudinal axis 10 with about the center of the arteriotomy 52). The 4 supplemental sealer delivery device 18 can transmit acoustic energy to the arteriotomy 5 52. 6 [0074] Figure 20 illustrates a method for applying energy (e.g., RF or microwave) to the 7 tensioned arteriotomy 52. The supplemental sealer delivery device 18 can extend into 8 about the center of the arteriotomy 52. The supplemental sealer delivery device 18 can 9 be an RF transducer. The first and/or second expander wires 16a and/or 16b can be RF or 10 microwave transducers (e.g., microwave antenna). For example, the first and/or second 11 expander wires 16a and/or 16b can be first RF poles, and the supplemental sealer delivery 12 device 18 can be a second RF pole. 13 [0075] Figure 21 illustrates a method for applying the sealer (e.g., energy or liquid) into 14 the tensioned arteriotomy 52 using the web 38. The web 38 can be an RF transducer, 15 and/or a resistive heater, and/or an inductive heater and/or microwave heater. The web 16 38 can be hollow and have holes or pores (not shown). The web 38 can be in fluid 17 communication with a hollow first and/or second expander wires 16a and/or 16b. The 18 web 38 can transfer a liquid, for example a sealer, into the arteriotomy 52. 19 100761 Once the web 38 applies the sealer to the tensioned arteriotomy 52, the web can 20 be removed from the expander wire tips 22a and 22b, and left in the arteriotomy 52 when 21 the remainder of the closure device 2 is removed. The web 38 can be absorbed by the 22 tissue surrounding the arteriotomy 52. 20 1 [0077] Figure 22 illustrates a method for applying liquid sealer into the tensioned 2 arteriotomy 52. The liquid sealer can flow, as shown by arrows, from the delivery holes 3 36 into the arteriotomy 52. Liquid sealers (e.g., biocompatible adhesives, biocompatible 4 epoxies, PEG) for filling and sealing arteriotomies 52 are known to those having ordinary 5 skill in the art. The sealer can act as an adhesive. The adhesive can act as a filler, for 6 example PEG. The sealer can be bioabsorbable. 7 [00781 The arteriotomy 52 can be partially or completely sealed by the energy. Fluid 8 flow can be substantially and/or completely stopped (i.e., hemostasis). Fluid flow 9 through the arteriotomy 52 can be partially or completely sealed by the energy. 10 [0079] The supplemental sealer delivery device 18, and/or the web 38, and/or the 11 expander wire tips 22a and 22b can be electrical resistive heater elements. The sealer can 12 be direct heat transferred through conduction, and/or convection, and/or radiative heating. 13 The supplemental sealer delivery device 18 can heat the arteriotomy directly through 14 conduction. 15 100801 Any combination of energies, in any proportion, can be applied to the arteriotomy 16 52. For example, RF or other heating energy can initially be applied to the tensioned 17 arteriotomy 52. The RF or other heating energy can then be stopped and acoustic energy 18 can be applied to the tensioned arteriotomy 52. 19 10081] Resistive heat energy (i.e., conducted heat generated by electrical resistors) and 20 acoustic energy can be applied simultaneously and in any proportion to the arteriotomy 21 52. RF energy and resistiv heat energy can be applied simultaneously and in any 22 proportion to the arteriotomy 52. Acoustic energy and RF energy can be applied 23 simultaneously and in any proportion to the arteriotomy 52. Acoustic energy and 21 I inductive energy can be applied simultaneously and in any proportion to the arteriotomy 2 52. Resistive heat energy, acoustic energy, RF energy, inductive energy and/or 3 microwave energy can be applied simultaneously and in any proportion to the 4 arteriotomy 52. 5 [00821 Figures 23 and 24 illustrate a treatment area that can have skin 68 separated from 6 the vessel 70 by subcutaneous tissue 72 (e.g., fat, muscle, other vessels). An external 7 transducer 74 can be in contact with or adjacent to the skin 68. A gel or other contact 8 supplement known to one having ordinary skill in the art can be sued to improve energy 9 conduction between the external transducer 74 and the skin 68. 10 100831 After the arteriotomy is substantially sealed, the holes in the lumen wall 54 from 11 which the expander wires 16a and 16b and/or the supplemental sealer delivery device 18 12 are removed can be inconsequentially small so that bleeding from the holes can be 13 negligible. Sealing (e.g., heating) can be performed as the closure device 2 is removed 14 from the arteriotomy 52 so as to close an holes in the lumen wall 54 formed by the 15 removal of the closure device 2. 16 [00841 The external transducer 74 can be an acoustic transducer, such as an ultrasonic 17 imager, HIFU, image guided HIFU; a radiological transducer, such as an x-ray imager; a 18 magnetic imager, such as a magnetic resonance imager (MRI); therapeutic versions of the 19 aforementioned imagers, or combinations thereof. 20 100851 The external transducer 74 can be used to send energy waves 76 to the 21 arteriotomy 52. The energy waves 76 can reflect from, transmit through, and/or resonate 22 from the arteriotomy 52 and/or the expander wire tips 22a and 22b. Reflected and/or 23 transmitted and/or resonated energy waves 76 can be received by the external transducer 22 1 74 and used to detect the condition (e.g., morphology, structure) and location of the 2 arteriotomy 52 and the expander wire tips 22a and 22b. The external transducer 74 can 3 track the location of the arteriotomy 52 and the expander wire tips 22a and 22b. 4 [00861 The expander wire tips 22a and 22b can have a material or configuration that 5 enhances the ability of the external transducer 74 to detect the expander wire tips 22a and 6 22b. For example, the expander wire tips 22a and 22b can have an echogenic and/or 7 radiopaque material and/or configuration, such as radiopaque materials listed supra. The 8 first and second expander wire tips 22a and 22b can frame the arteriotomy 52 location 9 and provide a target got an image-guided external transducer 74 (e.g., image guided 10 IFU). The energy waves 76 can be therapeutic energy, for example used to seal the 11 arteriotomy 52. The energy waves 76 can be focused on the arteriotomy 52, and can 12 transmit minimal energy into surrounding tissue. For example, the energy waves 76 can 13 be therapeutic ultrasound broadcast from a phased array such that a node of the energy 14 waves 76 is located at the arteriotomy 52. 15 [00871 The closure device 2 can be removed from the arteriotomy 52. The closure 16 device 2 can be directly withdrawn from the arteriotomy, for example in a parallel 17 direction with the tip longitudinal axes 24a and 24b. The closure device 2 can be 18 withdrawn from the arteriotomy 52 while the first and second expander wires 16a and 19 16b are in an expanded configuration. 20 [00881 Before the closure device is withdrawn from the arteriotomy 52, and/or 21 subcutaneous tissue track, the inner member 6 can be retracted into the delivery guide 4, 22 with or without fully retracting the expander wires 16a and 16b into the first and second 23 wire ports 12a and 12b. The delivery guide 4 can be moved distally relative to the inner 23 I member 6, reversing the method shown in Figures 11 through 16, and changing the 2 closure device 2 into a retracted configuration. The closure device 2 can then be removed 3 from the arteriotomy 52 with the expander wires 16a and 16b in an expanded or retracted 4 configuration. 5 [00891 If the arteriotomy 52 was created by a surgical procedure using a hollow member, 6 such as a catheter, or there is otherwise a catheter in the arteriotomy 52 prior to 7 performing the methods described herein, the already-deployed catheter can be used as 8 the delivery guide 4, or as a sheath for the delivery guide 4. 9 100901 The closure devices and methods shown and described herein can be used 10 integrally and/or in other combinations with access and closure devices and methods 11 shown and described in U.S. Patent Application No. 10/844,247 filed 12 May 2004, and 12 incorporated herein by reference in its entirety. For example, the arteriotomy 52 can be 13 at an angle with respect to the lumen, wherein the angle can be from about 200 to about 14 900, more narrowly from about 30* to about 600, for example about 450, or otherwise 15 described in U.S. Patent Application No. 10/844,247. Also for example, the arteriotomy 16 52 can have a shape as described by U.S. Patent Application No. 10/844,247. The 17 devices and methods described herein can be used in combination with the supplemental 18 closure devices, such as tensioners, clips, toggles, sutures, and combinations thereof, 19 described by U.S. Patent Application No. 10/844,247. 20 [0091] It is apparent to one skilled in the art that various changes and modifications can 21 be made to this disclosure, and equivalents employed, without departing from the spirit 22 and scope of the invention. Elements shown with any embodiment are exemplary for the 23 specific embodiment and can be used on other embodiments within this disclosure. 24