Balloon Closure Device

Abstract

A system for sealing a percutaneous puncture communicating with a blood vessel in a living being and method of use thereof. The system, referred to in the present embodiment, as a balloon closure device, includes an inner member, referred to as an anchor catheter, slidable within an outer member, referred to as an occlusion catheter, and separate expandable members, referred to as balloons, coupled to the distal ends of both the anchor and occlusion catheters. Also, incorporated into the distal end of the anchor catheter are blood vessel locator holes for determining the position of the blood vessel via the percutaneous puncture. The vessel locator includes means for enabling blood from the vessel to flow therethrough so that the position of the vessel can be rapidly determined. Once the balloon closure device has been extended into the puncture and the vessel has been located, the ballon closure device may be deployed. The anchor catheter and its balloon are located within the blood vessel, while the occlusion catheter and its balloon are located within the puncture tract leading to the vessel. Once the balloon closure device is positioned, hemostasis occurs rapidly, and the necessary components are locked in place.

A proximal end of the occlusion catheter includes a port for delivering fluid into the balloon, and a cylindrical lumen that communicates with the port. A proximal end of the anchor catheter includes a port for delivering fluid into the balloon, and a cylindrical lumen that communicates with the port. The anchor catheter may also include a cylindrical lumen to accommodate a guidewire. The balloon closure device is introduced like a standard sheath exchange. First, the existing sheath is removed over a guidewire. Next, the occlusion catheter coupled with an inner distally tapered anchor catheter/introducer is passed over the guidewire through the puncture, disposing the anchor catheter/introducer with its collapsed balloon in the vessel lumen, while the occlusion catheter with its collapsed balloon is disposed in the puncture tract. Once vessel lumen location is confirmed, fluid is introduced into the anchor catheter port, inflating the anchor balloon. The anchor balloon is withdrawn to seal the puncture. The occlusion catheter is advanced to the distal end of the puncture tract just outside the vessel wall, and abutting the inflated anchor balloon. Fluid is introduced into the occlusion catheter port, inflating the occlusion balloon, to both occlude the puncture and secure the occlusion catheter in the puncture tract. The anchor balloon is then deflated, allowing the anchor catheter/introducer to be withdrawn into the puncture tract and removed. Once hemostasis is confirmed, the guidewire is removed. After an interval, the occlusion balloon may be deflated to check for hemostasis. Once hemostasis is confirmed, the remaining occlusion catheter may be removed, leaving nothing behind but the body's own hemostatic plug.

Claims

1. A system for sealing a percutaneous puncture in the wall of a vessel, duct or lumen of a living being, the vessel, duct or lumen having a fluid therein, the puncture comprising an opening in the wall of the vessel, duct or lumen and a tract contiguous with the opening and extending through tissue overlying the vessel, duct or lumen, said system comprising a closure device which extends from outside the being's body to a distal location inside the being's body.

2. The system of claim 1, wherein said closure device is comprised of: an outer member, referred to as an occlusion catheter, comprising proximal and distal ends defining a longitudinal axis therebetween, and a lumen extending between the proximal and distal ends; an expandable balloon member, referred to as an occlusion balloon, coupled to the distal end of the occlusion catheter, such that an interior of the occlusion balloon communicates with a balloon inflation lumen, the occlusion balloon being expandable from a collapsed state to an expanded state when fluid is introduced into the interior; an inner member, referred to as an anchor catheter, slidably coupled to the occlusion catheter and comprising proximal and distal ends; an expandable balloon member, referred to as an anchor balloon, coupled to the distal end of the anchor catheter such that an interior of the anchor balloon communicates with a balloon inflation lumen, the anchor balloon being expandable from a collapsed state to an expanded state when fluid is introduced into the interior; a vessel locator coupled to the proximal and distal ends of the anchor catheter.

3. The system of claim 2, wherein said vessel locator is arranged for introduction into the puncture to provide a perceptible signal indicative of the location of the wall of the vessel, duct or lumen, whereupon a desired position for said closure device with respect to the vessel, duct or lumen may be determined, said vessel locator comprising means for insertion in the puncture tract to a position at which the fluid within the vessel, duct or lumen is enabled to flow from the interior thereof into said vessel locator to provide said perceptible signal, said closure device being arranged to be positioned within a portion of the puncture in accordance with said desired position to enable the effective sealing of the puncture by said closure device.

4. The system of claim 3, wherein said vessel locator includes means for conveying the fluid from the interior of the vessel, duct or lumen to a location outside the body of the being for detection thereof.

5. The system of claim 2, wherein said anchor catheter of said closure device is arranged to be located within the interior of the vessel, duct or lumen.

6. The system of claim 5, wherein the vessel, duct or lumen comprises a blood vessel and the fluid comprises blood, and wherein said anchor catheter of said closure device is arranged to be located within the interior of the blood vessel.

7. The system of claim 5, wherein said anchor catheter is adapted to be brought into engagement with tissue contiguous with the opening in the vessel, duct or lumen in the interior of the vessel, duct or lumen.

8. The system of claim 2, wherein said occlusion catheter of said closure device is arranged to be located in the puncture tract.

9. The system of claim 2, wherein the outer member comprises a tubular member, and wherein the inner member is slidable within the outer member.

10. The system of claim 2, wherein the inner member extends through the lumen of the outer member, the inner member having a cross-section smaller than a cross-section of the lumen to allow the inner member to easily pass through the lumen.

11. The system of claim 2, wherein the expandable member coupled to the outer member comprises a balloon, and wherein the balloon is coated with a procoagulant material to enhance coagulation and hemostasis.

12. The system of claim 2, wherein the expandable member coupled to the inner member comprises a balloon.

13. A method for sealing a percutaneous puncture in the wall of a vessel, duct or lumen of a living being, the vessel, duct or lumen having a fluid therein, the puncture comprising an opening in the wall of the vessel, duct or lumen and a tract contiguous with the opening and extending through tissue overlying the vessel, duct or lumen, said method comprising: (a) providing a closure device with an anchor catheter including a vessel locator, and an occlusion catheter; (b) introducing the anchor catheter's vessel locator into the puncture to a position whereupon the fluid within the vessel, duct or lumen is enabled to flow from the interior of the vessel, duct or lumen into the vessel locator to provide a perceptible signal indicative of the location of the wall of the vessel, duct or lumen, whereupon a desired position for the anchor catheter and closure device with respect to the vessel, duct or lumen may be determined; and (c) introducing the closure device within a portion of the puncture in accordance with the desired position to enable the effective sealing of the puncture by said closure device; such desired position comprises positioning the anchor catheter and anchor balloon within the vessel, duct or lumen, and positioning the occlusion catheter and occlusion balloon within the puncture tract. (d) causing the closure device to seal the puncture.

14. The method of claim 13 additionally comprising the step of conveying the fluid from the interior of the vessel, duct or lumen to a location outside the body of the being for detection thereof

15. The method of claim 13, wherein said closure device comprises an anchor catheter arranged to be located within the interior of the vessel, duct or lumen, and distally advancing said closure device comprises causing said anchor catheter to be located within the interior of the vessel, duct or lumen.

16. The method of claim 15, wherein said anchor balloon of said anchor catheter is arranged to be brought into engagement with tissue contiguous with the opening in the vessel, duct or lumen on the interior of the vessel, duct or lumen.

17. The method of claim 13, wherein said occlusion catheter of said closure device is arranged to be positioned in the puncture tract to seal the vessel, duct or lumen.

18. The method of claim 17, wherein said occlusion balloon of said occlusion catheter is arranged to be brought into engagement with tissue contiguous with the opening in the vessel, duct or lumen on the exterior of the vessel, duct or lumen.

19. The method of claim 13, wherein said expandable member, referred to as an anchor balloon, and said expandable member, referred to as occlusion balloon, may each be reversibly expanded or inflated, and collapsed or deflated, to seal the puncture.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is an exploded perspective view of a preferred embodiment of a system for sealing a puncture through tissue, in accordance with the present invention.

[0025] FIG. 2 is a perspective view, showing an operator inserting a guide wire into a patient's blood vessel.

[0026] FIG. 3 is a schematic representation of a preferred embodiment of a system for sealing a puncture through tissue, in accordance with the present invention, shown as a cross-sectional illustration. In this embodiment, the original sheath has been exchanged for the balloon closure device, including the occlusion catheter with its central anchor catheter/introducer. The anchor catheter/introducer extends into the arterial lumen, and the occlusion catheter resides in the puncture tract. Both catheters have their balloons deflated.

[0027] FIG. 4 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the vessel locator demonstrates blood flow from the arterial lumen, confirming the anchor catheter's location in the arterial lumen.

[0028] FIG. 5 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the anchor balloon is inflated and the anchor catheter/introducer is pulled back, occluding the puncture.

[0029] FIG. 6 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the occlusion catheter is advanced to the distal end of the puncture tract, abutting the inflated anchor balloon, and the occlusion balloon is inflated to occlude the puncture and the puncture tract.

[0030] FIG. 7 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the anchor balloon is deflated and hemostasis, resulting from the inflated occlusion balloon, is assessed.

[0031] FIG. 8 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the anchor catheter is removed, the occlusion balloon fills the vacated space, and hemostasis is assessed.

[0032] FIG. 9 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, hemostasis is confirmed and the guidewire is removed.

[0033] FIG. 10 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, a hemostatic layer has formed at the puncture site, adjacent to the inflated occlusion balloon.

[0034] FIG. 11 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the occlusion balloon is deflated to assess the stability of the hemostatic layer that has formed at the puncture site.

[0035] FIG. 12 is a schematic representation of a one embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, hemostasis is confirmed and the balloon closure device has been removed, leaving behing a hemostatic plug.

[0036] FIG. 13 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the vessel locator demonstrates blood flow from the arterial lumen, confirming the dilator/introducer catheter's location in the arterial lumen.

[0037] FIG. 14 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, an alternative anchor balloon, which has been passed through the dilator/introducer catheter's guide wire lumen into the blood vessel, is inflated and is pulled back, occluding the puncture.

[0038] FIG. 15 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the occlusion catheter is advanced to the distal end of the puncture tract, abutting the inflated alternative anchor balloon, and the occlusion balloon is inflated to occlude the puncture and the puncture tract.

[0039] FIG. 16 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the alternative anchor balloon is deflated and hemostasis, resulting from the inflated occlusion balloon, is assessed.

[0040] FIG. 17 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the dilator/introducer and alternative anchor balloon are removed, the occlusion balloon fills the vacated space, and hemostasis is assessed.

[0041] FIG. 18 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, a hemostatic layer has formed at the puncture site, adjacent to the inflated occlusion balloon.

[0042] FIG. 19 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, the occlusion balloon is deflated to assess the stability of the hemostatic layer that has formed at the puncture site.

[0043] FIG. 20 is a schematic representation of an alternative embodiment of the balloon closure device, shown as a cross-sectional illustration. In this embodiment, hemostasis is confirmed and the balloon closure device has been removed, leaving behing a hemostatic plug.

[0044] FIGS. 21A-21G are cross-sectional views of a percutaneous puncture communicating with a blood vessel showing a method for sealing the puncture, in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Referring now in greater detail to the various figures of the drawings wherein like reference characters refer to like parts. Turning to the drawings, FIGS. 1-12, show a preferred embodiment of the system, referred to as the balloon closure device 10 for sealing a puncture extending through tissue and/or communicating with a body lumen. The puncture 190 includes not only the opening in the wall of the vessel but also the puncture tract 190A, i.e., the passageway in the tissue located between the vessel and the skin of the being formed when the vessel is punctured.

[0046] The balloon closure device 10 has particular utility when used in connection with intravascular procedures, such as angiographic dye injection, cardiac catheterization, balloon angioplasty and other types of recanalizing of atherosclerotic arteries, etc. since the balloon closure device 10 is designed to cause immediate hemostasis of the blood vessel, e.g., arterial, puncture. However, it is to be understood that while the description of the preferred embodiment closure device contained herein is directed to the closing off of percutaneous incisions or punctures in arteries, it has much more wide-spread applications. Thus, the sealing of a percutaneous opening in an artery shown herein is merely exemplary.

[0047] Generally, the balloon closure device 10 includes an occlusion catheter 12, an anchor/introducer catheter 32 slidably coupled to the occlusion catheter 12, a hub connector 38 or other mechanism for biasing the anchor catheter 32 relative to the occlusion catheter 12, an anchor balloon or other expandable member 80, a vessel locator 28 coupled to the anchor catheter 32, and an occlusion balloon or other expandable member 82 coupled to the occlusion catheter 12. Ideally, the balloon closure device 10 will be able to use the anchor/introducer catheter 32 to facilitate passage of the balloon closure device through the puncture tract 190A and puncture 190, to reach the body lumen 194. Otherwise, a peel-away introducer sheath (not shown) may be needed to facilitate such passage.

[0048] With reference to FIGS. 1-12, the occlusion catheter 12 may be an elongate tubular body including a proximal end 14, a distal end 16, and a lumen 18 extending therebetween (shown in FIGS. 1-8), thereby defining a longitudinal axis. The occlusion catheter 12 may be flexible, semi-rigid, or rigid, e.g., having a uniform or variable flexibility along its length. The occlusion catheter 12 may be formed from a variety of materials providing a desired rigidity, e.g., plastic, such as polyamide, PEEK, nylon, PET, PEBAX, polyethylene, and/or metal, such as stainless steel or a nickel-titanium alloy, fabricated using known processes, e.g., extrusion, roll forming, machining, and the like. Optionally, a lubricious coating (not shown) may be provided on the exterior of the occlusion catheter 12, e.g., Dow 360 silicone fluid.

[0049] Preferably, the distal end 16 of the occlusion catheter 12 is attached to the occlusion balloon 82, as explained further below. Preferably, the distal end 16 is substantially flexible such that the distal end 16 may curve, bend, or otherwise conform substantially to the contour of the puncture tract 190A into which the distal end 16 is advanced. The occlusion catheter 12 is designed to preferentially remain in the puncture tract 190A and not extend into the puncture 190 and/or body lumen, and as such, it will not enlarge the diameter of the puncture hole. The distal end 16 of the occlusion catheter 12 may have a size sufficient to be inserted into a relatively small puncture tract. For example, the distal end 16 (and possibly the remainder of the occlusion catheter 12) may have an outer diameter between about 0.090-0.120 inch (2.28-3.05 mm). The minimum achievable dimensions of the balloon closure device and its components may be larger or smaller than mentioned herein. The balloon closure device and its components may be progressively scalable to correspond to the original sheath and puncture size.

[0050] The anchor catheter/introducer 32 may preferably be used to facilitate passage of the balloon closure device 10. Alternatively, a peel-away introducer sheath (not shown) may be provided that is exchanged with the original sheath, to facilitate passage of the balloon closure device 10, and to facilitate subsequent sheath removal. Exemplary materials for the anchor catheter/introducer 32, and, if needed, the peel-away introducer sheath may include plastics, such as polyamide, PEEK, nylon, PET, PEBAX, and polyethylene, metals, such as stainless steel, and nickel titanium, and/or composite materials.

[0051] The anchor catheter/introducer 32, or the peel-away introducer sheath may enhance a rigidity and/or pushability of the balloon closure device 10, i.e., may be sufficiently rigid to support the balloon closure device 10, e.g., to prevent the balloon closure device 10 from buckling or kinking when being advanced through the puncture tract, across a puncture, and into the body lumen, as desired. The anchor catheter/introducer 32 is designed to advance across the puncture 190, and into the body lumen.

[0052] In addition, the peel-away introducer sheath may be used to exchange one balloon closure device 10 for another, e.g., in the event that the anchor balloon 80 ruptures or if a different size anchor balloon is desired. Furthermore, the peel-away introducer sheath may include a side port (not shown) on its proximal end for delivering a fluid.

[0053] With continued reference to FIGS. 1-12, the anchor catheter/introducer 32 may be an elongate body including a proximal end 34, and a distal end 36. Preferably, as best seen in FIGS. 3-7, the anchor catheter 32 is slidably received within the lumen 18 of the occlusion catheter 12 such that the distal end 36 of the anchor catheter 32 extends beyond the distal end 16 of the occlusion catheter 12. The lumen 18 of the occlusion catheter 12, may have an inner diameter between about 0.068-0.076 inch (1.73-1.93 mm).

[0054] When the anchor catheter 32 is disposed within the lumen 18, the distal end 36 of the anchor catheter 32 may extend substantially beyond the distal end 16 of the occlusion catheter 12. Preferably, the distal end 36 of the anchor catheter 32 is attached to the anchor balloon 80, as explained further below. The distal end 36 of the anchor catheter 32 may be tapered and may terminate in a substantially flexible and/or atraumatic distal tip, e.g., a J tip and the like (not shown).

[0055] The anchor catheter 32 may preferably be a hollow wire, hypotube, catheter, and the like, formed from a variety of materials, e.g., plastic and/or metal, similar to the occlusion catheter 12. For example, the distal end 36 (and possibly the remainder of the anchor catheter 32) may be polymeric having an outer diameter between about 0.065-0.073 inch (1.65-1.85 mm), and therefore able to pass through the lumen 18 of the occlusion catheter 12. Preferably, the anchor catheter 32 may include a lumen for receiving a guidewire 22 therethrough, e.g., such that the anchor catheter 32 may be advanced over a guidewire. The guidewire may have an outer diameter between about 0.021-0.025 inch (0.53-0.64 mm). Larger scaled versions of the balloon closure device 10 may accommodate a standard guidewire with an outer diameter of about 0.035 inch (0.89 mm).

[0056] Preferably, the anchor catheter 32 may be biased to move distally relative to the occlusion catheter 12, so that the anchor catheter 32 may pass through the puncture and enter the body lumen, while the occlusion catheter 12 may remain within the puncture tract.

[0057] Turning to FIG. 3, the hub connector 38 may be provided for biasing the anchor catheter 32 relative to the occlusion catheter 12. The hub connector 38 may include cooperating connectors, e.g., hemostatic y connectors (not shown), that may be used for flushing a fluid through the occlusion catheter lumen 18, and for reversibly locking the occlusion catheter 12 to the inner nested anchor catheter 32, as needed. Generally, the hub connector 38 may extend from the proximal end 14 of the occlusion catheter 12. For example, the hub connector 38 may be attached to the proximal end 14 of the occlusion catheter 12 using an adhesive, an interference fit, mating threads, and the like, e.g., to substantially permanently attach the hub connector 38 to the proximal end 14 of the occlusion catheter 12. With the hub connector 38 attached to the occlusion catheter 12, the side port (not shown) may communicate with the occlusion catheter lumen 18. Thus, fluid delivered into the side port may enter the lumen 18.

[0058] The side port (not shown) may include a connector, e.g., a luer lock connector, or a nipple (not shown) for connecting tubing or otherwise connecting a source of fluid (not shown) to the side port. For example, a syringe (not shown) filled with fluid, e.g., saline, and the like, may be connected to the side port for manually delivering the fluid into the lumen 18. Alternatively, a pump or other device (not shown) may be provided for delivering fluid at a desired pressure and/or flow rate.

[0059] The hub connector 38 may include a hemostatic connector (not shown) with an adjustable central aperture (not shown). The distal end 36 of the anchor catheter 32 may be inserted into the aperture, allowing the anchor catheter 32 to pass through the occlusion catheter lumen 18, across the puncture, and into the body lumen. The anchor catheter 32 may be fixed in an axial position relative to the occlusion catheter 12, by tightening the central aperture of the hemostatic connector of the hub connector 38, for example, using a compression spring, a hemostatic valve, or other mechanism, as is known in the art. The proximal ends of the occlusion catheter 12 and anchor catheter 32, may each include annular bands or other markers (not shown) thereon that may become aligned when the distal ends of the catheters are offset as desired, as discussed below.

[0060] The anchor balloon 80 and the occlusion balloon 82 may each be inflated by using a viscous fluid (i.e., a fluid more viscous than air). This should avoid the introduction of any significant amount of air into any body lumen where air does not belong. Preferentially, fluid may be injected into the balloon using a predetermined volume that will achieve a desired balloon diameter based on the balloon's compliance characteristics. If a predetermined pressure is needed for proper balloon inflation, then some type of visual indication or gauge may be provided to indicate that the predetermined pressure has been reached. The predetermined pressure may correspond to a desired maximum pressure for a balloon, e.g., to ensure that the balloon is expanded to a desired diameter and/or to prevent risk of the balloon rupturing.

[0061] Turning to FIGS. 3-11, the anchor balloon 80 and the occlusion balloon 82 may each be reversibly expandable from a collapsed state to an expanded state when an inflation medium (not shown) is introduced into the interior of each balloon. In an alternative embodiment, other expandable members, e.g., a mechanically expandable or self-expanding member (not shown) may be provided instead of a balloon.

[0062] The balloons 80 and 82 may each be formed from a flexible, substantially inelastic material, e.g., a nonelastomeric material, such as PET, nylon, PEBAX, and the like, that may provide a substantially noncompliant balloon that may expand to a predetermined size once a minimum pressure is introduced into the interior. In this embodiment, the size of the balloons 80 and 82 in the expanded state may be fixed. Alternatively, the balloons 80 and 82 may each be formed from an elastic material, such as POC, polyethylene, polyurethane, silicone, and the like, such that the size of the balloons 80 and 82 in the expanded state is dependent upon the volume of fluid delivered within the interior, as is known in the art.

[0063] In a preferred embodiment, as seen in FIG. 6, the anchor balloon 80 includes a proximal end 84, a distal end 86, and an expandable intermediate section defining the interior 71 of the anchor balloon 80. The proximal and distal ends 84 and 86, respectively, of the anchor balloon 80 may be attached to the distal end 36 of the anchor catheter 32, but, preferably, proximal to its tapered tip. The interior 71 of the anchor balloon 80 may communicate with the balloon inflation lumen 35 of the anchor catheter 32. Similarly, the occlusion balloon 82 includes a proximal end 83, a distal end 85, and an expandable intermediate section defining the interior 72 of the occlusion balloon 82. The proximal end 83 of the occlusion balloon 82 may be attached to the distal end 16 of the occlusion catheter 12, and the distal end 85 of the occlusion balloon 82 may be attached to or may extend beyond the distal end 16 of the occlusion catheter 12. The interior 72 of the occlusion balloon 82 may communicate with the balloon inflation lumen 15 of the occlusion catheter 12.

[0064] Preferably, as best seen in FIG. 6, the proximal and distal ends 84 and 86, respectively, of the anchor balloon 80 may overlie and be attached to the distal end 36 of the anchor catheter 32, e.g., using an adhesive, sonic welding, crimping, a compressive sleeve, an interference fit, and the like. Similarly, the proximal and distal ends 83 and 85, respectively, of the occlusion balloon 82 may overlie and be attached to the distal end 16 of the occlusion catheter 12, e.g., using an adhesive, sonic welding, crimping, a compressive sleeve, an interference fit, and the like.

[0065] The distal end 86 of the anchor balloon 80 may preferably be attached proximal to the tapered portion of the anchor catheter 32 and not extend beyond the distal end 36 of the anchor catheter 32, e.g., to allow for the least diameter profile for the distal tip of the anchor catheter 32. The anchor balloon 80 may have a length of at least about five millimeters (5 mm). The distal end 85 of the occlusion balloon 82 may extend beyond and preferably, in this embodiment, wrap around the distal end 16 of the occlusion catheter 12, and extend into the occlusion catheter lumen 18.

[0066] This design may allow the occlusion balloon to inflate and atraumatically occlude both the puncture and the puncture tract, over time facilitating hemostasis within a puncture in a wall of a body lumen. The occlusion balloon 82 may have a length of at least about twenty millimeters (20 mm) on the outer surface of the occlusion catheter 12 and possibly a length of at least about ten millimeters (10 mm) on the inner luminal surface of the occlusion catheter 12. This length is based on the punctured blood vessel and the length of its associated puncture tract requiring occlusion, e.g. the femoral artery versus the radial artery which has a very short puncture tract.

[0067] In the collapsed state, shown in FIGS. 3 and 4, the anchor and occlusion balloons 80 and 82, respectively, may conform substantially to the diameter of the anchor and occlusion catheters 32 and 12, respectively. The anchor balloon 80 is expanded to the expanded state, shown in FIGS. 5 and 6, by introducing an inflation medium (not shown) into the balloon inflation lumen 35 of the anchor balloon 80, and consequently into the interior 71 of the anchor balloon 80. The occlusion balloon 82 is expanded to the expanded state, shown in FIGS. 6-10, by introducing an inflation medium (not shown) into the balloon inflation lumen 15 of the occlusion balloon 82, and consequently into the interior 72 of the occlusion balloon 82. The balloon inflation lumens may each include one or more seals (not shown), separate lengths of tubing, a hemostatic adapter, stopcock, and the like, attached, to its proximal end, e.g., to prevent substantial proximal flow of fluid through the lumen and to maintain balloon inflation pressure, as is known in the art.

[0068] Optionally, not shown, the balloon closure device 10 may include other components, e.g., to provide a kit for performing a procedure on a patient. For example, an introducer sheath, preferably a valved hemostatic peel-away introducer sheath, may be provided that includes a proximal end, a distal end, and a lumen extending therebetween. The introducer sheath may include a dilator with a tapered distal tip that may be inserted into the lumen of the introducer sheath, e.g., for facilitating advancing the introducer sheath through a puncture, as is known to those skilled in the art. In addition, the introducer sheath may include a side port on the proximal end communicating with the lumen and/or may include one or more seals (not shown), e.g., to prevent substantial proximal flow of fluid through the lumen, as is known in the art. The side port may include one or more components, e.g., separate lengths of tubing, stopcocks and the like (not shown), as will be appreciated by those skilled in the art. In addition, the kit may include a syringe, not shown, or other device for delivering fluid into the side port of the introducer sheath, as well as for delivering inflation medium into the balloon inflation lumens, as explained above. A syringe may be connected to the side port of the introducer sheath for injecting fluid into the introducer sheath lumen, and similarly into ports located on the proximal ends of the balloon inflation lumens.

[0069] Optionally, the kit may also include a stylet or obturator (not shown) that may be inserted into the lumen of the introducer sheath, e.g., to facilitate percutaneously inserting the introducer sheath through tissue, as is known to those skilled in the art. In addition, or alternatively, one or more guidewires (not shown) may also be provided.

[0070] Turning to FIGS. 1-21, a method for sealing a passage through tissue is shown. Preferably, the passage is a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen. For example, the vessel may be a peripheral artery or vein, e.g., a femoral artery, a femoral vein, a carotid artery, and the like.

[0071] Before further describing the use of the balloon closure device 10 to seal a puncture, a brief description of a typical, conventional, intravascular surgical procedure, e.g., catheter instrumentation of an artery, utilizing a percutaneous opening will be given to best appreciate the features of the invention. In such a procedure a cannula of an instrument, such as an angiographic needle (not shown), is inserted percutaneously through the skin into the artery, such as the femoral artery, at the situs for the closure device's insertion. The needle cannula is held in place and the flexible end of a mini-guidewire (not shown) is then passed through the cannula into the artery to the desired depth (i.e., longitudinal position therealong). Once the mini-guidewire is in place the needle cannula is removed, leaving the guidewire in place. An introducer sheath (not shown) and an arterial dilator (not shown) are then passed over the guidewire, through the puncture or incision and into the artery. The guidewire and then the dilator are removed leaving the introducer sheath in place.

[0072] One or more instruments (not shown) may be advanced through the introducer sheath and into the vessel, e.g., to perform a diagnostic and/or therapeutic procedure within the patient's body, e.g., threaded down the artery to the desired intravascular location, e.g., the situs of the atherosclerotic occlusion. The one or more instruments may include catheters, e.g., balloon catheters, stent delivery catheters, imaging catheters, and the like, guidewires, and/or other devices. Upon completing the intravascular procedure(s), any instruments may be removed. Thereafter, the sheath is removed and a physician or other trained person applies manual, digital pressure to the percutaneous puncture until hemostasis has occurred. In particular, the current standard of care for puncture hemostasis is to apply digital or mechanical pressure on the puncture site for twenty minutes to an hour, depending on the puncture size and the degree of hemolytic therapy. Obviously, this results in wasted time for the physicians and other catheter lab personnel, and causes inconvenience and discomfort for the patient. In addition, serious complications arise from persistent bleeding and hematoma formation in approximately five percent of the patients. A much better option is to employ a system to seal the arterial puncture site 190 and plug the puncture tract 190A, such as that shown in FIGS. 1-21 and described above. Moreover, as will be appreciated from the description to follow, the balloon closure device 10 is designed to reduce post-procedure puncture complications, cause minimal inflammatory reaction, and leave nothing behind in the vessel or puncture tract.

[0073] Turning to FIGS. 3 and 4, with the anchor and occlusion balloons, 80 and 82, respectively, in the collapsed state, and using the anchor catheter 32 as an introducer, the balloon closure device 10 may be inserted through the puncture tract lumen 190A, over the device exchange guidewire 22, until the anchor catheter's distal end has passed through the puncture 190 and is disposed within the vessel 194. This may be indicated by blood entering intraluminal ports referred to as vessel locator distal holes 28, passing through a marker lumen 27, and exiting the vessel locator proximal hole 26. The distal holes, marker lumen, and proximal hole are all part of the anchor catheter 32. The marker lumen allows a pathway for back-bleeding (obtaining mark) from the body lumen, e.g., a femoral artery, to ensure proper device positioning. Optionally, the balloon closure device 10 may include one or more markers, e.g., radiopaque markers (not shown), to facilitate monitoring insertion of the system 10 using external imaging, e.g., fluoroscopy, ultrasound, magnetic resonance imaging (Mill), and the like.

[0074] Alternatively or in addition, one or more visual markers (not shown) may be provided, e.g., on the proximal end 34 of the anchor catheter 32, and on the proximal end 14 of the occlusion catheter 12, respectively. The markers may include one or more colored bands at predetermined locations along a length of the anchor catheter 32 relative to the anchor balloon 80. For example, a distance between a band on the proximal end 34 of the anchor catheter 32 may correspond to a length of the anchor catheter 32, thereby providing a visual indication when the anchor catheter 32 has been advanced sufficiently to expose the anchor balloon 80 beyond the distal end 16 of the occlusion catheter. Similarly, the markers may include one or more colored bands at predetermined locations along a length of the occlusion catheter 12 relative to the distal end 16 of the occlusion catheter 12, with the distance between bands corresponding to the length of insertion of the occlusion catheter 12 into the puncture tract 190A. Together, these markers may provide a visual indication when the balloon closure device 10 has been advanced sufficiently through the puncture and into the vessel lumen.

[0075] As shown in FIGS. 4 and 5, once the anchor balloon 80 is disposed within the vessel lumen and blood is exiting the vessel locator proximal hole 26, the anchor balloon 80 may be expanded to the expanded state, e.g., by introducing fluid into the balloon inflation lumen 35 through the anchor catheter 32 and into the anchor balloon 80. A prescribed amount of fluid may be introduced so that the anchor balloon 80 may be expanded to a desired size. An additional mechanism may be provided to inform the user that a desired pressure has been reached within the anchor balloon. In addition, one or more mechanisms may be provided to prevent deflation of the anchor balloon including a stopcock, and possibly a hemostatic valve connected to the balloon inflation lumen. The hemostatic valve may have a quick connect adapter requiring a syringe to be attached and locked into the adapter before inflation or deflation may occur.

[0076] The anchor catheter 32 may be removed, if desired. For example, if the anchor balloon 80 accidentally ruptures, the anchor catheter 32 may be removed and replaced with another anchor catheter having an intact balloon (not shown). In addition or alternatively, if it is discovered that the anchor balloon 80 is the wrong size for the given anatomy (e.g., is too small for the puncture or too large for the vessel), the anchor catheter 32 may be replaced with one having a larger or smaller balloon. This may be avoided by the anchor balloon 80 having a range of possible sizes based on its degree of inflation.

[0077] As shown in FIG. 5, the anchor catheter 32 may be partially withdrawn from the arterial lumen with the anchor balloon 80 in the expanded state, i.e., until the anchor balloon 80 engages (catches) on the artery wall contiguous with the puncture. Preferably, the anchor balloon 80 substantially seals the puncture 190, i.e., substantially isolating the puncture 190 from the arterial lumen 194. Thus, the balloon closure device 10 may provide temporary hemostasis, e.g., preventing blood from passing through the puncture 190. Thus, even without the additional steps that follow, the balloon closure device 10 may be used to provide hemostasis in emergency situations in order to minimize loss of blood until a puncture victim may be treated.

[0078] In the preferred embodiment, the anchor balloon 80 in the expanded state, as described above, may be particularly suited for providing hemostasis, while still allowing blood flow to continue along the arterial lumen 194. For example, as shown in FIG. 5, the diameter of the anchor balloon 80 may be substantially greater than its length in the expanded state. Thus, when the anchor balloon 80 is pulled into engagement with the arterial wall 196 of the arterial lumen 194, at least a portion of the arterial lumen 194 may remain unobstructed, as shown.

[0079] As shown in FIG. 6, with an individual applying a proximal force to the anchor catheter 32 in order to maintain the anchor balloon 80 substantially against the puncture 190, the occlusion catheter 12 may be advanced to the distal end of the puncture tract 190A and the anchor catheter 32 and occlusion catheter 12 may be locked together at the hub connector 38. While reapplying a proximal force to the anchor catheter 32 in order to maintain the anchor balloon 80 substantially against the puncture 190, the occlusion balloon 82 may be inflated against the exterior of the artery contiguous with the puncture 190 to occlude the puncture and the puncture tract 190A. The balloon closure device 10 is now essentially locked in place in the puncture tract. If needed, a tensioner (not shown) may be provided that may apply a proximal force to the anchor catheter 32 to maintain the anchor balloon 80 substantially against the puncture 190. The tension imposed by the tensioner may apply a desired tensile force to the anchor balloon 80 to maintain hemostasis while preventing the anchor balloon 80 from being pulled into the puncture 190 and/or preventing the arterial wall 196 of the arterial lumen 194 from excessive tenting.

[0080] The occlusion balloon 82 may optionally be coated with a hemostasis-promoting material (not shown), e.g. chitosan, which may promote hemostasis within the puncture tract 190A. Because of the hemostasis provided by the anchor balloon 80, the hemostasis-promoting material on the occlusion balloon may be delivered to the puncture tract without substantial concern that the hemostasis-promoting material may leak into the arterial lumen 194.

[0081] As shown in FIGS. 7 AND 8, once the occlusion balloon 82 is fully inflated, the anchor balloon 80 may then be deflated to the collapsed state, and hemostasis may be assessed. Once hemostasis is confirmed, the anchor catheter 32 may then be withdrawn from the puncture 190, into the puncture tract 190A, and removed from the body. Similarly, as shown in FIG. 9, the device exchange guidewire 22 may be withdrawn from the puncture 190, into the puncture tract 190A, and removed from the body.

[0082] A syringe or other device (not shown) may be used to evacuate fluid via the side port of the balloon inflation lumen 35 to collapse the anchor balloon 80. Once fluid is removed, and the anchor balloon 80 is in the collapsed state, the anchor balloon 80 may be withdrawn through the puncture 190 and puncture tract 190A without substantially disturbing the inflated occlusion balloon 82. To facilitate removing the anchor balloon 80, a lubricious coating (not shown) may be provided on the exterior of the anchor balloon 80, e.g., Dow 360 silicone fluid. Such a coating may prevent the anchor balloon 80 from sticking to or otherwise pulling on the occlusion balloon 82 as the anchor balloon 80 is withdrawn.

[0083] The occlusion balloon may remain inflated in the tissue tract for a time duration based on patient-related factors including the size of the puncture and the patient's level of anticoagulation. This time duration may range from minutes to hours. With very large punctures, maintaining puncture tract occlusion overnight may also be a suitable option, while still allowing unobstructed blood flow to continue along the arterial lumen 194. It may be possible that, with the occlusion balloon inflated, a patient may ambulate without compromising the hemostatic process.

[0084] As shown in FIGS. 10 and 11, after sufficient time has elapsed, the occlusion balloon 82 may be deflated and hemostasis assessed, possibly both at rest and with ambulation. As shown in FIG. 12, once hemostasis is confirmed, the balloon closure device 10 may be completely removed from the body, leaving nothing behind but the body's own hemostatic plug 198.

[0085] FIGS. 13-20 demonstrate an alternative embodiment that may result in a smaller profile balloon closure device. In this embodiment, a low profile dilator/introducer is used instead of the anchor catheter. Such a dilator/introducer may similarly have a distal vessel locator to indicate entry into the blood vessel lumen, but would lack an anchor balloon. Instead, the guide wire may be removed and a simple balloon catheter, as is known in the art, may be advanced through the guide wire lumen, enter the blood vessel and function similarly to the anchor balloon. As shown in FIG. 14, the balloon 84 may be inflated and pulled back along with the dilator/introducer, to maintain the balloon 84 substantially against the puncture 190. The subsequent steps demonstrated in FIGS. 15-20 are substantially similar to those previously demonstrated in FIGS. 6-12, and described previously.

[0086] As may be appreciated by the description above, deployment of the balloon closure device is easy, quick, reliable, and should avoid significant discomfort to the patient. Hemostasis occurs almost instantaneously, e.g., in 15 seconds or less, when the closure device is deployed properly.

[0087] Should there be any residual bleeding from the puncture tract or arterial lumen, external pressure may be applied, e.g., by pressing manually against the skin 192 overlying the arterial lumen 194. External pressure may be maintained for sufficient time to allow substantial sealing of any residual bleeding remaining upon removing the balloon closure device 10.

[0088] As should be appreciated from the foregoing, the closure device, and its method of use enables the ready, effective and efficient sealing of a percutaneous puncture in an artery (or vein). Thus, it is expected that the balloon closure device 10 will be a significant advancement in the fields of cardiology and radiology. The device may allow continuance of anticoagulation post-procedure, more aggressive use of thrombolytic agents and safer use of large bore catheters. It should also reduce discomfort and complication rates for patients. It may allow early or even immediate ambulation with the device locked in place. It may allow many in-patient procedures to be performed safely on an out-patient basis, decrease the time and cost of interventional procedures, and reduce exposure of hospital personnel to human blood.

[0089] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims.