Fluidic media introduction apparatus

[0002] This application is a continuation-in-part of U.S. Patent Application Ser. No. 09/021,708, filed Feb. 10, 1998, now U.S. Pat. No. 6,302,898, and entitled “Devices for Sealing Punctures in Body Vessels.” This application is also a continuation-in-part of U.S. patent application Ser. No. 09/037,659, filed Mar. 10, 1998, and entitled “Universal Introducer,” which is itself related to United Provisional Patent Application Ser. No. 60/036,299, filed Mar. 12, 1997. This application is also a continuation-in-part of U.S. patent application Ser. No. 08/963,408, filed Nov. 3, 1997, and entitled “Vascular Sealing Device with Microwave Antenna,” now U.S. Pat. No. 6,033,401.

[0003] 1. Field of the Invention

[0004] This invention relates to a fluidic media introduction apparatus, and more particularly to a fluidic media introduction apparatus for closing an opening in a vessel wall.

[0005] 2. Description of Related Art

[0006] Various surgical procedures utilize percutaneous entry into a blood vessel or body cavity. Examples of such procedures include different techniques to recanalize atherosclerotic blood vessels, such as balloon angioplasty or atherectomy.

[0007] These procedures generally involve the percutaneous puncture with a thin walled needle into a blood vessel. Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn. An intravascular sheath of variable size is then advanced over the guidewire, percutaneously, into the lumen of the blood vessel. The introducer sheath is then used as an ingress/egress means during the procedure. Following completion of the procedure, the introducer sheath may be removed, but this requires the application of prolonged manual pressure over the puncture site by a physician or other suitably trained medical personnel. The time involved here is frequently extensive since patients are often treated with a variety of anticoagulant and thrombolytic agents, particularly in the setting of a heart attach. Alternatively, the sheath may be left in the puncture site for a prolonged period of time until the patient's coagulation status has returned to normal. Depending on the size of the size of the vascular sheath, there may be an increased risk of bleeding to the patient, which may require blood transfusion. in addition, there is a significant risk for injury to the blood vessel upon removal of the sheath, particularly if the sheath has been in place for a prolonged period of time. This includes the possible development of a pseudo-aneurysm or severe hematoma. Current methods for removal of introducer sheaths are painful to the patient and requires prolonged bed rest after removal. This adds to the discomfort for the patient, as well as prolonging hospitalization, and costs.

[0008] Many of the intra-vascular procedures are performed in patients who are clinically unstable or who have the potential to become so, following completion of the procedure. Following removal of the vascular access sheath, it could be cumbersome and sometimes difficult to re-enter the blood vessel if necessary. Thus, with the current technique for removal of the sheath following the procedure, no easy, reliable method is available to allow re-access to the lumen of the blood vessel, if necessary.

[0009] It would desirable to provide a fluid delivery device which provides vascular sealing and easy re-access to the lumen of the blood vessel. It would be further desirable to provide a fluid delivery device which provides vascular sealing and includes a mixing chamber for mixing a fluidic media.

[0010] Accordingly, an object of the invention is to provide a fluid delivery device.

[0011] Another object of the invention is to provide a fluid delivery device used for vascular sealing.

[0012] A further object of the invention is to provide a fluid delivery device that delivers a fluidic media to a vascular puncture site.

[0013] Still another object of the invention is to provide a fluid delivery device with a mixing chamber and a guide wire lumen, where the fluid delivery device is used for vascular sealing.

[0014] These and other objects of the invention are achieved in a fluidic media delivery apparatus for closing an opening in a vessel wall. The apparatus includes an elongated member with a fluidic media introduction port and a guide wire lumen. The guide wire lumen extends from a proximal portion to a distal portion of the elongated member. A fluidic media mixing chamber is positioned in the elongated member and coupled to a fluidic media introduction port. A fluidic media delivery lumen is coupled to the mixing chamber. A fluidic media advancement port is positioned at the distal portion of the elongated member. An inflatable member is coupled to the distal portion of the elongated member.

[0015] FIG. 1 is a cross-sectional view of a fluidic media delivery apparatus of the present invention with an elongated member, a guide wire lumen, a mixing chamber and a balloon coupled to a distal portion of the elongated member.

[0016] FIG. 2 is a cross-sectional view of the apparatus of FIG. 1 taken along the lines 2—2.

[0017] FIG. 3 is a cross-sectional view of the apparatus of FIG. 1 taken along the lines 3—3.

[0018] FIG. 4 is a cross-sectional view of a fluidic media delivery apparatus of the present invention similar to the apparatus of FIG. 1 but without a guide wire lumen.

[0019] FIG. 5 is a cross-sectional view of a mixing chamber of the FIG. 1 apparatus where the mixing chamber includes baffles.

[0020] FIG. 6 is a cross-sectional view of a mixing chamber of the FIG. 1 apparatus with a spiral baffle.

[0021] FIG. 7 is a cross-sectional view of a fluidic media delivery apparatus of the present invention similar to the apparatus of FIG. 1 but without an inflatable member at the distal portion of the elongated member.

[0022] FIG. 8 is a cross-sectional view of a mixing chamber useful with the apparatus of FIG. 1, where the mixing chamber includes baffles that guide the fluidic media from one side to the other of the mixing chamber.

[0023] FIG. 9 is a perspective view of a fluid delivery device with a syringe clip and two syringe holders.

[0024] FIG. 10 is a perspective view of the mixer from the apparatus of FIG. 9.

[0025] FIG. 11 is a cross-sectional view of the mixer of FIG. 10 taken along the lines 11—11.

[0026] FIG. 12 is a cross-sectional view of a multiple-nozzle from the apparatus of FIG. 9.

[0027] FIG. 13 is a cross-sectional view of a mixer and a joiner similar to that illustrated in FIG. 9 where the delivery ports of a two component fluidic media are separated.

[0028] FIG. 14 is a cross-sectional view of the apparatus of FIG. 14 taken along the lines 14—14.

[0029] FIG. 15 is a cross-sectional view of an embodiment of the apparatus of FIG. 9 with a static mixer.

[0030] FIG. 16 illustrates a fluidic media delivery apparatus with an elongated member, delivery port and a multiple lumen fluidic media delivery coupler.

[0031] FIG. 17 illustrates a fluidic media delivery apparatus with an elongated member, delivery port and a multiple lumen fluidic media delivery coupler connected to a mixer.

[0032] FIG. 18 illustrates a fluidic media delivery apparatus with an elongated member, delivery port and a multiple lumen fluidic media delivery coupler connected to a mixing chamber and spray nozzle.

[0033] Referring now to FIG. 1, a fluid delivery device 10 provides for vascular sealing and includes an elongated member 12 with a mixing chamber 14, a guide wire lumen 16 and a fluidic media introduction port 18. Coupled to elongated member 12 is an expandable member 20 that is coupled to an inflation lumen 22. Inflation lumen 22 is coupled to an inflation port 24. In one embodiment, expandable member 20 is a balloon or basket that is positioned at a distal portion of elongated member 12. Balloon 20 is positioned proximal to a distal end of guide wire lumen 16. Balloon 20 can be made of a variety of materials including but not limited to PE, PET, mylon, latex and the like. Elongated member 12 can be a sheath, introducer, cannula, catheter and the like. Mixing chamber 14 may be a hub that is coupled to elongated member 12. Fluidic media introduction port 18 and inflation port 24 can have connectors including but not limited to Luer-Lock connectors. A cap can be positioned at a proximal end of elongated member 12. A guide wire port is positioned at the proximal end of elongated member 12.

[0034] Elongated member 12 is sized to be introduced over a guide wire. A distal end of elongated member 12 is positioned in a vessel through a puncture site. Proximal to balloon 20 is a fluidic media delivery port 24 coupled to a fluidic media delivery lumen 23.

[0035] Apparatus 10 is a fluid delivery device for closing a site in a vessel, including but not limited to a puncture or other opening in a blood vessel which has been entered through percutaneous techniques. Apparatus 10 can be used with a standard percutaneous vascular sheath or introducer. In a preferred embodiment, apparatus 10 is used without a sheath or introducer. In this embodiment, elongated member 12 provides substantially the same function as a sheath or introducer and also serves to deliver a suitable fluidic media to a vessel closure site.

[0036] Elongated member 12 is rigid and can have a tubular geometric configuration. A diameter of elongated member 12 is less than a diameter of an access lumen of an introducer or sheath with which it is used and a length that is preferably at least 2 cm greater than that of the introducer. Balloon 20 can be coupled to elongated member 12 by a variety of different methods well known to those skilled in the art including but not limited to heat bonding or the use of adhesives. Elongated member 12 can be made of a variety of different materials including but not limited to HDPE, polyimide, mylon, stainless steel, a shape memory alloy and combinations thereof.

[0037] Elongated member 12 is positioned through a puncture site of a vessel over a guide wire with a distal end of elongated member 12 in the vessel. An inflation media is introduced through port 24 to inflate balloon 20. Balloon 20 is then inflated when it is in an interior of the vessel. A portion of the inflated balloon 20 abuts against an interior surface of the vessel wall at the puncture site. Fluidic media is then injected through fluidic media introduction port 18. The fluidic media, which can be one or more components, is flowable and can include solid particulates. The fluidic media is advanced through mixing chamber 14 by an external pressure application force that is delivered through port 18. After the fluidic media has been mixed and advanced through mixing chamber 14, the fluidic media travels through a lumen of elongated member that is preferably in a surrounding relationship to guide wire lumen 16. The fluidic media then seals the puncture site, balloon 20 is then deflated and the distal end of elongated member 12 removed from the interior of the vessel.

[0038] If required, elongated member 12 can again be introduced into the vessel, or other body tissue or site. In this embodiment, the guide wire is received once more in guide wire lumen 16. Elongated member 12 is reintroduced through the puncture site with balloon 20 deflated.

[0039] Inflated balloon 20 blocks egress of blood immediately upon being properly positioned in the blood vessel or other tissue site at the puncture site to provide quick hemostasis. Inflated balloon 20 can also acts as an internal marker to ascertain the depth of the puncture as well as the thickness of tissues surrounding the puncture. Additionally, inflated balloon 20 serves as a backstop to precisely position the fluidic media at the puncture site and reduce the chance of fluidic media entrance into vessel or other tissue site.

[0040] FIG. 3 illustrates the cross-section of elongated member at a point that is proximal to balloon 20. In one embodiment, inflation lumen 22 is in a surrounding relationship to guide wire lumen 16. Fluidic media delivery lumen 23 is in a surrounding relationship to inflation lumen 22. FIG. 4 illustrates the cross-section of elongated member at mixing chamber 14. As shown, baffles 26 are coupled to exterior surfaces of guide wire lumen 16 and interior surfaces of mixing chamber 14. Baffles 26 are arranged in a circumferential pattern to create a circumferential and circular flow and mixing of fluidic media.

[0041] Referring now to FIG. 4, another embodiment of apparatus 10 is illustrated that does not include a guide wire lumen. In this embodiment, the distal end of elongated member 12 is introduced into the vessel without a guide wire. Balloon 20 is inflated, fluidic media introduced and mixed in mixing chamber 14 and then advanced out of port 24 to seal the puncture site.

[0042] As illustrated in FIGS. 5 and 6, mixing chamber 14 can include baffles that are non-spiral (FIG. 5) or in a spiral configuration (FIG. 6). Other means of mixing beyond baffles are possible. Mixing chamber 14 can be in a surrounding relationship to guide wire lumen 16 or only at one side of guide wire lumen. Additionally, mixing chamber has sufficient length to ensure the desired mixing of the fluidic media that provides the sealing of the vessel, or other tissue site.

[0043] In another embodiment, illustrated in FIG. 7, apparatus 10 does not include an expandable member 20. The distal end of guide wire lumen 16 is inserted through the puncture site. Fluidic media is mixed in mixing chamber 14 and advanced out of elongated member 12 through port 24 and seals the puncture site.

[0044] Another embodiment of mixing chamber 14 is illustrated in FIG. 8. In this embodiment, baffles 26 are of different sides. Baffles 26 create mixing of the fluidic media by causing fluidic media to advance and move from one side of mixing chamber to the other. In this embodiment, two ports 18′ and 18″ are included. The embodiment of FIG. 8 is particularly suitable for fluidic media with two separate components that are separately introduced through ports 18′ and 18″ respectively.

[0045] Referring now to FIG. 9, another embodiment of apparatus 10 is illustrated. In this embodiment, a syringe clip 28 is used to introduce a two component fluidic media into lumen 23 of elongated member 12. A distal portion of syringe clip 28 is positionable in a first syringe body 30 and a second syringe body 32. First and second syringe bodies 30 and 32 are coupled to a joiner 34. Joiner 34 is coupled to a mixer 36 which in turn is connected to a nozzle 38. As illustrated in the sectional view of mixer 36 (FIG. 10), the two components that make up the fluidic media are introduced separately into mixer 36. As shown in FIG. 11, the two components travel in a swirling pattern in mixer 36 before they are ejected through nozzle 38.

[0046] In various embodiments, nozzle 38 can have multiple spray ports (FIG. 12), and the delivery ports of mixer 36 are separated for the different components of fluidic media to be mixed (FIGS. 13 and 14). As illustrated in FIG. 15, the introduction of the two components of a dual component fluidic media are separated until they reach a deliver port and/or nozzle 38. This creates a static mixing effect at the port.

[0047] FIGS. 16 through 18 illustrates various embodiments for mixing multiple component fluidic media that are used with apparatus 10. In FIG. 16, a multiple lumen fluidic media delivery coupler 40 includes four delivery lumens 42. Three of lumens 42 deliver the fluidic media to delivery port 18. In FIG. 17, the multiple component fluidic media is mixed in mixer 36 prior to delivery to lumens 42. In FIG. 18, multiple lumens 42 deliver the multiple component fluidic media to mixer 36, which is coupled to nozzle 38. Nozzle 38 is connected to elongated body 12.

[0048] The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope of the invention be defined by the following claims and their equivalents.