Patent ID: 12213656

DESCRIPTION

The present invention relates to a puncture sealing system or balloon closure device and a method of using the puncture sealing system. In particular, the invention relates to a puncture sealing system useful for sealing a puncture and a puncture tract in an improved manner. Although the invention is illustrated and described in the context of being useful for sealing a puncture following a vascular access procedure, the present invention can be used in other ways, as would be readily apparent to those of ordinary skill in the art. Accordingly, the present invention should not be limited just to the examples and embodiments described herein.

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 an embodiment of a puncture sealing system10of the invention. The puncture sealing system10is also known as a balloon closure device. By sealing it is meant at least partially sealing, occluding, blocking, coagulating, or the like. The puncture sealing system10may be used to seal a vascular puncture190extending through tissue and/or communicating with a body lumen. The puncture190includes not only the opening in the wall of the vessel but also the puncture tract190A, i.e., the passageway in the tissue extending from the puncture190and at least partially to the skin192and formed when the vessel is punctured.

Briefly,FIG.1shows an embodiment of a puncture sealing system10in accordance with the present invention.FIG.2shows an operator inserting a guide wire22into a patient's blood vessel prior to the sealing of the puncture.FIG.3shows a puncture sealing system10including an outer member11, such as an occlusion catheter12, and with an inner member31, such as an anchor catheter/introducer32. The anchor catheter/introducer32extends into the arterial lumen, and the occlusion catheter12resides in the puncture tract190A. The inner member31has an inner member expandable member79, such as anchor balloon80, and the outer member11has an occlusion balloon82, both of which are deflated inFIG.3.FIG.4shows the puncture sealing system10showing a vessel locator system25that demonstrates blood flow from the arterial lumen, confirming the anchor catheter's location in the arterial lumen194.FIG.5shows the anchor balloon80inflated and the anchor catheter/introducer32pulled back, occluding the puncture190.FIG.6shows the occlusion catheter12advanced to a distal end of the puncture tract190A, abutting the inflated anchor balloon80, and the occlusion balloon82is inflated to occlude the puncture190and the puncture tract190A.FIG.7shows the anchor balloon80deflated and hemostasis, resulting from the inflated occlusion balloon82, is assessed.FIG.8shows the anchor catheter32removed, the occlusion balloon82filling the vacated space, and hemostasis is assessed.FIG.9shows hemostasis being confirmed and the guidewire22is removed. InFIG.10, a hemostatic layer has formed at the puncture site, adjacent to the inflated occlusion balloon.FIG.11shows the occlusion balloon82deflated to assess the stability of the hemostatic layer that has formed at the puncture site190. InFIG.12, hemostasis is confirmed and the balloon closure device10has been removed, leaving behind a hemostatic plug198.

The puncture sealing system10has 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 puncture sealing system10is 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 closure device 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.

Generally, the puncture sealing system10includes an inner member31and an outer member11and optionally includes or is useable with a guidewire22. In the embodiment ofFIG.3, the outer member11comprises an occlusion catheter12, and the inner member31comprises an anchor/introducer catheter32slidably coupled to the occlusion catheter12. A hub connector38or other mechanism may be provided to bias the anchor catheter32relative to the occlusion catheter12. The anchor catheter32may also include an inner member expandable member79, such as an anchor balloon80or other expandable member40, and a vessel locator system25coupled to the anchor catheter32. The occlusion catheter32may also include, and an occlusion balloon or other expandable member82coupled to the occlusion catheter12. In this version, the puncture sealing system10will be able to use the anchor/introducer catheter32to facilitate passage of the puncture sealing system10through the puncture tract190A and puncture190, to reach the body lumen194. Otherwise, a peel-away introducer sheath (not shown) may be needed to facilitate such passage.

With reference toFIGS.1-12, the occlusion catheter12may be an elongate tubular body including a proximal end14, a distal end16, and a lumen18extending therebetween (shown inFIGS.1-8), thereby defining a longitudinal axis. The occlusion catheter12may be flexible, semi-rigid, or rigid, e.g., having a uniform or variable flexibility along its length. The occlusion catheter12may 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 catheter12, e.g., Dow360silicone fluid.

The distal end16of the occlusion catheter12may be attached to the occlusion balloon82, as explained further below. The distal end16may be substantially flexible such that the distal end16may curve, bend, or otherwise conform substantially to the contour of the puncture tract190A into which the distal end16is advanced. The occlusion catheter12is designed to preferentially remain in the puncture tract190A and not extend into the puncture190and/or body lumen, and as such, it will not enlarge the diameter of the puncture hole. The distal end16of the occlusion catheter12may have a size sufficient to be inserted into a relatively small puncture tract. For example, the distal end16(and possibly the remainder of the occlusion catheter12) may have an outer diameter between about 0.090-0.120 inch (2.28-3.05 mm). The minimum achievable dimensions of the puncture sealing system10and 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.

The anchor catheter/introducer32may be used to facilitate passage of the puncture sealing system10. Alternatively, a peel-away introducer sheath (not shown) may be provided that is exchanged with the original sheath, to facilitate passage of the puncture sealing system10, and to facilitate subsequent sheath removal. Exemplary materials for the anchor catheter/introducer32, 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.

The anchor catheter/introducer32, or the peel-away introducer sheath may enhance a rigidity and/or pushability of the puncture sealing system10, i.e., may be sufficiently rigid to support the puncture sealing system10, e.g., to prevent the puncture sealing system10from buckling or kinking when being advanced through the puncture tract, across a puncture, and into the body lumen, as desired. The anchor catheter/introducer32is designed to advance across the puncture190, and into the body lumen.

In addition, the peel-away introducer sheath may be used to exchange one puncture sealing system10for another, e.g., in the event that the anchor balloon80ruptures 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.

With continued reference toFIGS.1-12, the anchor catheter/introducer32may be an elongate body including a proximal end34, and a distal end36. As can be seen inFIGS.3-7, the anchor catheter32is slidably received within the lumen18of the occlusion catheter12such that the distal end36of the anchor catheter32extends beyond the distal end16of the occlusion catheter12. The lumen18of the occlusion catheter12, may have an inner diameter between about 0.068-0.076 inch (1.73-1.93 mm).

When the anchor catheter32is disposed within the lumen18, the distal end36of the anchor catheter32may extend substantially beyond the distal end16of the occlusion catheter12. The distal end36of the anchor catheter32may be attached to the anchor balloon80, as explained further below. The distal end36of the anchor catheter32may be tapered and may terminate in a substantially flexible and/or atraumatic distal tip, e.g., a “J” tip and the like (not shown).

The anchor catheter32may be a hollow wire, hypotube, catheter, and/or the like, formed from a variety of materials, e.g., plastic and/or metal, similar to the occlusion catheter12. For example, the distal end36(and possibly the remainder of the anchor catheter32) 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 lumen18of the occlusion catheter12. The anchor catheter32may include a lumen for receiving a guidewire22therethrough, e.g., such that the anchor catheter32may be advanced over a guidewire. The guidewire22may have an outer diameter between about 0.021-0.025 inch (0.53-0.64 mm). Larger scaled versions of the puncture sealing system10may accommodate a standard guidewire with an outer diameter of about 0.035 inch (0.89 mm).

The anchor catheter32may be biased to move distally relative to the occlusion catheter12, so that the anchor catheter32may pass through the puncture and enter the body lumen, while the occlusion catheter12may remain within the puncture tract.

Turning toFIG.3, the hub connector38may be provided for biasing the anchor catheter32relative to the occlusion catheter12. The hub connector38may include cooperating connectors, e.g., hemostatic y connectors (not shown), that may be used for flushing a fluid through the occlusion catheter lumen18, and for reversibly locking the occlusion catheter12to the inner nested anchor catheter32, as needed. Generally, the hub connector38may extend from the proximal end14of the occlusion catheter12. For example, the hub connector38may be attached to the proximal end14of the occlusion catheter12using an adhesive, an interference fit, mating threads, and the like, e.g., to substantially permanently attach the hub connector38to the proximal end14of the occlusion catheter12. With the hub connector38attached to the occlusion catheter12, the side port (not shown) may communicate with the occlusion catheter lumen18. Thus, fluid delivered into the side port may enter the lumen18.

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 lumen18. Alternatively, a pump or other device (not shown) may be provided for delivering fluid at a desired pressure and/or flow rate.

The hub connector38may include a hemostatic connector (not shown) with an adjustable central aperture (not shown). The distal end36of the anchor catheter32may be inserted into the aperture, allowing the anchor catheter32to pass through the occlusion catheter lumen18, across the puncture, and into the body lumen. The anchor catheter32may be fixed in an axial position relative to the occlusion catheter12, by tightening the central aperture of the hemostatic connector of the hub connector38, for example, using a compression spring, a hemostatic valve, or other mechanism, as is known in the art. The proximal ends of the occlusion catheter12and anchor catheter32, 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.

The anchor balloon80and the occlusion balloon82may 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.

Turning toFIGS.3-11, the anchor balloon80and the occlusion balloon82may 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.

The anchor balloon80and the occlusion balloon82may 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 balloons80and82in the expanded state may be fixed. Alternatively, the balloons80and82may each be formed from an elastic material, such as POC, polyethylene, polyurethane, silicone, and the like, such that the size of the anchor balloon80and the occlusion balloon82in the expanded state is dependent upon the volume of fluid delivered within the interior, as is known in the art.

In one embodiment, as seen inFIG.6, the anchor balloon80includes a proximal end84, a distal end86, and an expandable intermediate section defining the interior71of the anchor balloon80. The proximal and distal ends84and86, respectively, of the anchor balloon80may be attached to the distal end36of the anchor catheter32, but, preferably, proximal to its tapered tip. The interior71of the anchor balloon80may communicate with the balloon inflation lumen35of the anchor catheter32. Similarly, the occlusion balloon82includes a proximal end83, a distal end85, and an expandable intermediate section defining the interior72of the occlusion balloon82. The proximal end83of the occlusion balloon82may be attached to the distal end16of the occlusion catheter12, and the distal end85of the occlusion balloon82may be attached to or may extend beyond the distal end16of the occlusion catheter12. The interior72of the occlusion balloon82may communicate with the balloon inflation lumen15of the occlusion catheter12.

As can be seen, inFIG.6, the proximal end84and distal end86of the anchor balloon80may overlie and be attached to the distal end36of the anchor catheter32, e.g., using an adhesive, sonic welding, crimping, a compressive sleeve, an interference fit, and/or the like. Similarly, the proximal end83and the distal end85of the occlusion balloon82may overlie and be attached to the distal end16of the occlusion catheter12, e.g., using an adhesive, sonic welding, crimping, a compressive sleeve, an interference fit, and/or the like.

The distal end86of the anchor balloon80may be attached proximal to the tapered portion of the anchor catheter32and not extend beyond the distal end36of the anchor catheter32, e.g., to allow for the least diameter profile for the distal tip of the anchor catheter32. The anchor balloon80may have a length of at least about five millimeters (5 mm). The distal end85of the occlusion balloon82may extend beyond and wrap around the distal end16of the occlusion catheter12and may extend into the occlusion catheter lumen18. 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 balloon82may have a length of at least about twenty millimeters (20 mm) on the outer surface of the occlusion catheter12and possibly a length of at least about ten millimeters (10 mm) on the inner luminal surface of the occlusion catheter12. 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.

In the collapsed state, shown inFIGS.3and4, the anchor balloon80and/or occlusion balloon82may conform substantially to the diameter of the anchor catheter32and occlusion catheter12, respectively. The anchor balloon80is expanded to the expanded state, shown inFIGS.5and6, by introducing an inflation medium (not shown) into the balloon inflation lumen35of the anchor balloon80, and consequently into the interior71of the anchor balloon80. The occlusion balloon82is expanded to the expanded state, shown inFIGS.6-10, by introducing an inflation medium (not shown) into the balloon inflation lumen15of the occlusion balloon82, and consequently into the interior72of the occlusion balloon82. 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.

Optionally, not shown, the puncture sealing system10may include other components, e.g., to provide a kit for performing a procedure on a patient. For example, an introducer sheath, such as 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.

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.

Turning toFIGS.1-21, a method for sealing a passage through tissue is shown. The passage may be 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.

Before further describing the use of the puncture sealing system10to 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.

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 site190and plug the puncture tract190A, such as that shown inFIGS.1-21and described above. Moreover, as will be appreciated from the description to follow, the puncture sealing system10is designed to reduce post-procedure puncture complications, cause minimal inflammatory reaction, and leave nothing behind in the vessel or puncture tract.

Turning toFIGS.3and4, with the anchor balloon80and the occlusion balloon82in the collapsed state, and using the anchor catheter32as an introducer, the puncture sealing system10may be inserted through the puncture tract lumen190A, over the device exchange guidewire22, until the anchor catheter's distal end has passed through the puncture190and is disposed within the vessel194. This may be indicated by the vessel locating system25. With the vessel locating system25blood enters one or more intraluminal ports referred to as vessel locator distal holes28, passes through a marker lumen27, and exits through one or more vessel locator proximal holes26. The one or more vessel locator distal holes28, marker lumen27, and one or more vessel locator proximal holes26may all be an integral part of the anchor catheter32or may be separable therefrom. The marker lumen27allows a pathway for back-bleeding (obtaining mark) from the body lumen, e.g., a femoral artery, to ensure proper device positioning.

Optionally, the puncture sealing system10may include one or more markers, e.g., radiopaque markers (not shown), to facilitate monitoring insertion of the system10using external imaging, e.g., fluoroscopy, ultrasound, magnetic resonance imaging (“MRI”), and the like.

Alternatively or in addition, one or more visual markers (not shown) may be provided, e.g., on the proximal end34of the anchor catheter32, and on the proximal end14of the occlusion catheter12, respectively. The markers may include one or more colored bands at predetermined locations along a length of the anchor catheter32relative to the anchor balloon80. For example, a distance between a band on the proximal end34of the anchor catheter32may correspond to a length of the anchor catheter32, thereby providing a visual indication when the anchor catheter32has been advanced sufficiently to expose the anchor balloon80beyond the distal end16of the occlusion catheter. Similarly, the markers may include one or more colored bands at predetermined locations along a length of the occlusion catheter12relative to the distal end16of the occlusion catheter12, with the distance between bands corresponding to the length of insertion of the occlusion catheter12into the puncture tract190A. Together, these markers may provide a visual indication when the puncture sealing system10has been advanced sufficiently through the puncture and into the vessel lumen.

As shown inFIGS.4and5, once the anchor balloon80is disposed within the vessel lumen and blood is exiting the vessel locator proximal hole26, the anchor balloon80may be expanded to the expanded state, e.g., by introducing fluid into the anchor balloon inflation lumen35through the anchor catheter32and into the anchor balloon80. A prescribed amount of fluid may be introduced so that the anchor balloon80may 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.

The anchor catheter32may be removed, if desired. For example, if the anchor balloon80accidentally ruptures, the anchor catheter32may 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 balloon80is the wrong size for the given anatomy (e.g., is too small for the puncture or too large for the vessel), the anchor catheter32may be replaced with one having a larger or smaller balloon. This may be avoided by the anchor balloon80having a range of possible sizes based on its degree of inflation.

As shown inFIG.5, the anchor catheter32may be partially withdrawn from the arterial lumen with the anchor balloon80in the expanded state, i.e., until the anchor balloon80engages (catches) on the artery wall contiguous with the puncture. Preferably, the anchor balloon80substantially seals the puncture190, i.e., substantially isolating the puncture190from the arterial lumen194. Thus, the puncture sealing system10may provide temporary hemostasis, e.g., preventing blood from passing through the puncture190. Thus, even without the additional steps that follow, the puncture sealing system10may be used to provide hemostasis in emergency situations in order to minimize loss of blood until a puncture victim may be treated.

The anchor balloon80in the expanded state, as described above, may be particularly suited for providing hemostasis, while still allowing blood flow to continue along the arterial lumen194. For example, as shown inFIG.5, the diameter of the anchor balloon80may be substantially greater than its length in the expanded state. Thus, when the anchor balloon80is pulled into engagement with the arterial wall196of the arterial lumen194, at least a portion of the arterial lumen194may remain unobstructed, as shown.

As shown inFIG.6, with an individual applying a proximal force to the anchor catheter32in order to maintain the anchor balloon80substantially against the puncture190, the occlusion catheter12may be advanced to the distal end of the puncture tract190A and the anchor catheter32and occlusion catheter12may be locked together at the hub connector38. While reapplying a proximal force to the anchor catheter32in order to maintain the anchor balloon80substantially against the puncture190, the occlusion balloon82may be inflated against the exterior of the artery contiguous with the puncture190to occlude the puncture and the puncture tract190A. The puncture sealing system10is 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 catheter32to maintain the anchor balloon80substantially against the puncture190. The tension imposed by the tensioner may apply a desired tensile force to the anchor balloon80to maintain hemostasis while preventing the anchor balloon80from being pulled into the puncture190and/or preventing the arterial wall196of the arterial lumen194from excessive tenting.

The occlusion balloon82may optionally be coated with a hemostasis-promoting material (not shown), e.g. chitosan, which may promote hemostasis within the puncture tract190A. Because of the hemostasis provided by the anchor balloon80, 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 lumen194.

As shown inFIGS.7AND8, once the occlusion balloon82is fully inflated, the anchor balloon80may then be deflated to the collapsed state, and hemostasis may be assessed. Once hemostasis is confirmed, the anchor catheter32may then be withdrawn from the puncture190, into the puncture tract190A, and removed from the body. Similarly, as shown inFIG.9, the device exchange guidewire22may be withdrawn from the puncture190, into the puncture tract190A, and removed from the body.

A syringe or other device (not shown) may be used to evacuate fluid via the side port of the balloon inflation lumen35to collapse the anchor balloon80. Once fluid is removed, and the anchor balloon80is in the collapsed state, the anchor balloon80may be withdrawn through the puncture190and puncture tract190A without substantially disturbing the inflated occlusion balloon82. To facilitate removing the anchor balloon80, a lubricious coating (not shown) may be provided on the exterior of the anchor balloon80, e.g., Dow360silicone fluid. Such a coating may prevent the anchor balloon80from sticking to or otherwise pulling on the occlusion balloon82as the anchor balloon80is withdrawn.

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 lumen194. It may be possible that, with the occlusion balloon inflated, a patient may ambulate without compromising the hemostatic process.

As shown inFIGS.10and11, after sufficient time has elapsed, the occlusion balloon82may be deflated and hemostasis assessed, possibly both at rest and with ambulation. As shown inFIG.12, once hemostasis is confirmed, the puncture sealing system10may be completely removed from the body, leaving nothing behind but the body's own hemostatic plug198.

FIGS.13-20demonstrate another embodiment of a puncture sealing system10according to the invention. The embodiment ofFIGS.13-20may result in a smaller profile balloon closure device. In this embodiment, an inner catheter system includes a first catheter, the inner member31, which comprises a low profile dilator/introducer52instead of the anchor catheter. Like the anchor catheter32in the embodiment ofFIGS.3-12, the dilator/introducer52may have a vessel locator system25to indicate entry into the blood vessel lumen. The dilator/introducer52in this version may lack an anchor balloon and guidewire. The inner catheter system further includes a second catheter, a simple balloon catheter62, as is known in the art, that may be advanced through the guide wire lumen, enter the blood vessel and function similarly to the anchor balloon80. As shown inFIG.14, the inner catheter system expandable member79comprises a balloon catheter balloon81that may be inflated through lumen45and pulled back along with the dilator/introducer52, to maintain the balloon catheter balloon81substantially against the puncture190. The subsequent steps demonstrated inFIGS.15-20are substantially similar to those previously demonstrated inFIGS.6-12, and described previously.

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.

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 skin192overlying the arterial lumen194. External pressure may be maintained for sufficient time to allow substantial sealing of any residual bleeding remaining upon removing the puncture sealing system10.

As should be appreciated from the foregoing, the closure device, and its method of use, as shown inFIGS.21A through21G, enables the ready, effective and efficient sealing of a percutaneous puncture in an artery (or vein). Thus, it is expected that the puncture sealing system10will 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.

FIGS.22-28show another embodiment of a puncture sealing system10according to the invention. The embodiment ofFIGS.22-28shares many features and similarities with the embodiment ofFIGS.3-12. For example, the embodiment ofFIGS.22-28has an inner member31, such as an anchor catheter32that is slidably received within an outer member11, such as an occlusion catheter12. The anchor catheter32has an expandable member79in the form of an anchor balloon80, and the occlusion catheter12has an occlusion balloon82near the occlusion catheter distal end16. In the embodiment ofFIGS.22-28, the occlusion balloon proximal end83extends to the distal end16at a position proximal to the distal tip17of the distal end16in similar manner as the embodiment ofFIGS.3-12. The distance of the attachment of the proximal end83to the distal tip17corresponds generally to the amount of puncture tract190A that is to be occluded. For example, the distance from the attachment of the proximal end83to the distal tip can range from about 20 mm to about 40 mm and in one particular version is about 30 mm. In the embodiment ofFIGS.22-28, the occlusion balloon distal end85is attached to the occlusion catheter12at or just proximal to the distal tip17. Unlike the embodiment ofFIGS.3-12where the occlusion balloon82wraps around the distal end16of the occlusion catheter12so that the inflated occlusion balloon82can cover substantially the entire puncture190, in the embodiment ofFIGS.22-28, the occlusion balloon82does not extend beyond the distal end16of the occlusion catheter12and/or does not wrap around the distal end16of the occlusion catheter12. Accordingly, in this version, the inflated occlusion balloon does not cover the entire puncture190and covers only a portion of the puncture190or does not cover any of the puncture190.

As shown inFIGS.22,23, and24, the initial manner of operation of the puncture sealing system10of this embodiment is similar to the initial steps shown inFIGS.3-6discussed above. However, as can be seen inFIG.24, when inflated, the occlusion balloon82does not wrap around the distal end16of the occlusion catheter12and thus the inflated occlusion balloon distal end85extends across a smaller portion of the puncture190. The inflated occlusion balloon distal end85extends to or slightly beyond the distal end16in the distal direction extends inwardly towards the center of the occlusion catheter12to a lesser extent than theFIGS.3-12embodiment and in the version shown does not extend inwardly at all. An additional difference between theFIGS.22-28embodiment and theFIGS.3-12embodiment is the positioning of the one or more distal holes28of the vessel locator system25. In this version, the one or more distal holes28are located within about 3 mm of the anchor balloon proximal end84and in one version are located within about 1 mm of the anchor balloon proximal end84. This reduced distance allows for more precise positioning of the anchor balloon80in proximity to the arterial wall196. This provides an improved double-detection mechanism for assuring proper positioning of the anchor catheter32with the anchor balloon80against the arterial wall196providing the operator with a feeling of slight resistance at the same time that blood flow through the vessel locator system25is abruptly terminated. Also, as shown inFIGS.22-28vessel locator proximal hole26is accompanied by a vessel locator port26′. The vessel locator hole26and the vessel locator port26′ operate differently. The vessel locator hole26allows spontaneous flow to emanate if the puncture sealing system10is being used in an artery that's under pressure, while the vessel locator port26′ is a port that requires aspiration of blood with a syringe if the puncture sealing system10is being used in a vein that's not under high pressure. Also, as illustrated inFIGS.22-24, the puncture sealing system10of this version can ensure that the occlusion balloon distal end85is positioned precisely within the vessel wall to enable occlusion and prevent blood from leaking into the surrounding tissue. To accomplish this, the occlusion catheter distal end16needs to be positioned just proximal and adjacent to the distal vessel locator hole28, and the anchor catheter32and occlusion catheter12can be locked in this position as a unit by hub connector38. By locking puncture sealing system10in this position, once the anchor catheter32is properly positioned, the occlusion balloon82can be inflated without any distal advancement of occlusion catheter12needed. In some circumstances, it may be needed to lock the anchor catheter32and the occlusion catheter12with the distal tip of the occlusion catheter12positioned more proximally, such as when it is desirable to not have the occlusion catheter12pass through the puncture190. In this case, after the double detection mechanism positions the anchor catheter32, then the anchor catheter32is stabilized and the occlusion catheter12is advanced distally to a hard stop to achieve the desired occlusion balloon position.

Referring now toFIGS.24-26, the puncture sealing process of the embodiment ofFIGS.22-28involves the deflation of the anchor balloon80and removal of the anchor catheter32prior to the puncture190being sealed.FIG.25. shows the anchor catheter32removed and replaced by an obturator91. The obturator91is a solid but flexible catheter that may be made of a similar material as the anchor catheter32and is sized, shaped, and configured to be insertable within the occlusion catheter lumen18. The obturator91is sufficiently long that a distal end92can extend to or just beyond the occlusion catheter distal end16. In this position, the distal end92of the obturator91operates in conjunction with the occlusion balloon distal end85to enable sealing or occlusion of the puncture190, as shown inFIG.26. The distal end92has a surface adapted to cover the puncture190in a region not covered by the inflated occlusion balloon82to enable the occlusion of the puncture. The surface may be adapted to cover substantially the entire puncture190or may be adapted to cover a portion of the puncture190, such as a central portion within a portion that is covered by the inflated occlusion balloon82. Once the puncture190and puncture tract190A is sealed, the occlusion balloon82can be deflated and the puncture sealing system10can be removed from the area of the puncture tract190A.

Optionally, the obturator distal end92can be configured to help facilitate hemostasis. For example, in one version, the obturator distal end92can be an expandable member so that when in position, the distal end92can expand to cover a larger portion of the puncture190. The expandable member can be self-expanding, such as by being made of shape memory material, or can be inflatable like a balloon. In another version, the obturator distal end92can be composed of liquid silicone rubber or the like. The obturator distal end92and/or the occlusion balloon82may be coated with a procoagulant material, such as Chitosan, to enhance coagulation and hemostasis.

The embodiment ofFIGS.22-28also may include a hemostasis detection system95. The hemostasis detection system95comprises an opening96into the occlusion catheter lumen18at the distal end16of the occlusion catheter12. A hemostasis detection system lumen97communicates the opening96with a hemostasis detection system port98at the occlusion catheter proximal end14. As shown inFIG.27, to detect the level of hemostasis that has occurred, the obturator91can be moved proximally and slightly away from the puncture190. If hemostasis is not complete, there will be blood present within the occlusion catheter lumen18. By applying aspiration to the port98, any such blood can be detected as it passes through the opening96and travels down the lumen97. If, on the other hand, hemostasis in complete, the aspiration process will reveal little or no blood.

FIG.29shows another embodiment of a puncture sealing system10according to the invention. The embodiment ofFIG.29is similar to the version shown in connection withFIGS.22-28. However, in the embodiment ofFIG.29, the vessel locator system25includes one or more second distal holes29that communicate with one or more second proximal holes30. The one or more second distal holes29are located at a position proximally spaced from the one or more distal holes28. The one or more distal holes28and the one or more second distal holes29provide an alternative method for assuring proper positioning of the anchor catheter32. Initially the anchor catheter32is advanced distally with distal hole28and second distal hole29both entering the blood vessel lumen194at which point blood is detected emanating from proximal hole26and second proximal hole30. As the anchor catheter32is retracted proximally, second distal hole29will exit the blood vessel lumen194and blood will abruptly stop emanating from second proximal hole30, while distal hole28remains in the blood vessel lumen194, and blood is still emanating from proximal hole26. This is the desired position for anchor catheter32. If anchor catheter32is retracted more proximally, then blood flow will abruptly stop emanating from both proximal hole26and second proximal hole30, which indicates that the operator has pulled back too far. In one version the second distal holes29are separated proximally from the distal holes by from about 0.25 mm to about 3 mm, and in one version from about 0.25 mm to about 1 mm.

FIG.30shows another embodiment of a puncture sealing system10according to the invention. The embodiment ofFIG.30is similar to the version shown in connection withFIGS.22-28. However, in the embodiment ofFIG.30, the occlusion balloon distal end85does not extend beyond the occlusion catheter distal end16and does not contact the space of the puncture190. Instead, the obturator91includes an expandable distal end92that expands outside the occlusion catheter12to cover the entire or nearly the entire puncture190. An inflation lumen93can be provided in the obturator91for inflation of the expandable distal end91. Use of a medical foam that is compressed while it passes through the occlusion catheter lumen but expands towards its uncompressed size after exiting the occlusion catheter lumen distally is another alternative.

Another embodiment, not shown, that may be used as a possible closure device in more superficial blood vessels, e.g., the radial artery, may use the above-described dilator/introducer with more than one distal vessel locator, to position the closure device in the arterial lumen. The puncture tract of the radial artery is very short and may only accommodate a very short occlusion balloon, which may not be an effective way of stabilizing the closure device in the puncture tract. It may be preferable to use a different expandable member around the occlusion catheter, e.g., a medical foam, that may extend along a length of the occlusion catheter and may provide a frictional interface for stabilizing the closure device in the puncture tract. A circumferential compressive wrist band using velcro, may be needed along with or in place of the occlusion catheter expandable member, to stabilize the closure device in the puncture tract. This closure device may similarly use an obturator with expandable member, to completely seal the puncture and the distal puncture tract.

Although the present invention has been described in considerable detail with regard to certain preferred versions thereof, other versions are possible, and alterations, permutations and equivalents of the version shown will become apparent to those skilled in the art upon a reading of the specification and study of the drawings. For example, the cooperating components may be reversed or provided in additional or fewer number. Also, the various features of the versions herein can be combined in various ways to provide additional versions of the present invention. Furthermore, certain terminology has been used for the purposes of descriptive clarity, and not to limit the present invention. Throughout this specification and any claims appended hereto, unless the context makes it clear otherwise, the term “comprise” and its variations such as “comprises” and “comprising” should be understood to imply the inclusion of a stated element, limitation, or step but not the exclusion of any other elements, limitations, or steps. Therefore, any appended claims should not be limited to the description of the preferred versions contained herein and should include all such alterations, permutations, and equivalents as fall within the true spirit and scope of the present invention.