Patent Description:
For many diagnostic and interventional procedures it is necessary to access arteries or veins. Vessel access is accomplished either by direct vision or percutaneously. In either case, the target vessel is punctured with a hollow needle containing a tracer wire. When the intravascular positioning of the tracer wire has been verified, the hollow needle is removed leaving the tracer wire. Next, a sheath containing a dilator is pushed in over the tracer wire. The dilator enlarges the puncture opening to facilitate the insertion of the larger diameter sheath into the blood vessel. The sheath usually consists of a hollow tube with an open distal end and a hemostatic valve at a proximal end, which remains outside the body and blood vessel. The hemostatic valve is made of a compliant material and is designed in such a way as to allow devices such as catheters to be inserted and withdrawn from the blood vessel with minimal blood loss. After the sheath has been inserted into the blood vessel, the dilator is removed leaving a clear passageway in the sheath for the catheter. The sheath is removed from the blood vessel after the procedure is finished resulting in bleeding at the puncture site that must be staunched.

Traditionally, pressure is applied to the puncture site to allow time for the blood to clot thereby stopping the bleeding. Depending on the amount of anticoagulants that may have been administered to the patient during and prior to the procedure, the time pressure must be maintained varies from <NUM> minutes to more than an hour. Once bleeding has stopped, a pressure bandage is placed over the site of the puncture in an attempt to protect the integrity of the clot. The pressure bandage must remain in place for some time, usually from <NUM> to <NUM> hours. During this period of time the patient must remain in bed, sometimes requiring an overnight hospital stay.

To shorten the length of time required for the patient to become ambulatory and to lessen complications sometimes arising from the traditional method, several closure devices have been developed. One such device, as described in <CIT>, a foldable sheet with an attachment thread is inserted into the opening in the blood vessel and an arresting element is applied over the attachment element against the outside of the blood vessel. Another such device is described in <CIT> and <CIT>, and includes an absorbable collagen plug cinched down against an absorbable intervascular anchor via an absorbable suture. The anchor has an elongated rectangular shape that requires it to be inserted into the puncture wound with its longitudinal axis parallel to the sheath axis. This requires it to be rotated ninety degrees after insertion so that blood flow obstruction is minimized. A specially designed sheath is necessary to assure proper rotation, thus resulting in an otherwise unnecessary sheath change. The long dimension of the anchor is thus larger than the cannula inside diameter (ID) and the width is smaller than the ID. The collagen plug is in an elongated state prior to deployment and is forced into a ball shape via a slipknot in the suture, which passes through the collagen, and a tamper that applies a distal force to it. The anchor acts as a support for the suture cinch which forces the collagen ball shape up against the exterior vessel wall and the anchor. Blood flow escaping around the anchor is slowed down and absorbed by the collagen material and thus forms a clotting amalgamation outside the blood vessel that is more stable than the traditional method of a standalone clot. The added robustness of the amalgamation clot allows earlier ambulation of the patient.

The device raises several issues. It is not a true sealing device but rather a clotting enhancement device, as opposed to a device with two flat surfaces exerting sealing pressure on both the interior and exterior of the blood vessel, a much more reliable technique. In either case bleeding occurs during the time between removal of the sheath and full functionality of the deployed device. Thus "instant" sealing pressure from two flat surfaces is desirable over a method that relies to any extent on clotting time. One such device is disclosed by Bates et. The device disclosed in <CIT> comprises an internal sealing surface pivoting on a rigid post to accommodate the longitudinal dimension of the seal inside the sheath ID. The exterior seal (second clamping member) is slidable along the rigid post and pivotal such that it, along with the internal seal, sandwiches the wall of the blood vessel via a locking ratchet. One problem with this design is that the pivoting feature increases the cross-sectional dimension of the seal thus requiring a larger diameter sheath than would be otherwise needed. In addition, the pivoting internal seal has no means to assure that the seal pivots to the correct sealing position as the ratchet closes. This could cause the internal seal to exit the blood vessel in the collapsed configuration as the user withdraws the deploying device.

The seals are release by the user cutting the suture thread in the device described in<CIT>.

It is known that the opening in the blood vessel closes to some extent after the sheath is removed thus allowing smaller seal surfaces than would otherwise be required. What is less known is that the opening does not close as quickly as a truly elastic material such as natural rubber. For this reason seal surfaces of closure devices that are activated in less than a second, or perhaps even longer, after sheath removal must be physically larger than the sheath outside diameter to avoid embolization of the seals because of the delayed vessel closure. The design of seals that are deployed through a sheath ID with dimensions larger than the sheath OD upon deployment is a challenge since the preferred material for seals are bio-absorbable and thus have limited mechanical properties.

The device disclosed by <CIT> requires removing the catheter sheath and replacing it with a custom sheath prior to deployment, resulting in addition blood loss.

The tamping force used to deploy the collagen against the anchor is left to the surgeon's feel sometimes resulting in inadequate deployment and other times resulting in the collagen being pushed through the puncture wound, into the blood vessel along with the anchor. Inadequate tamping results in excessive bleeding with the potential for painful hematoma and over tamping can result in a surgical procedure to remove the device from the blood vessel lumen. In addition, the absorption rate of the suture, the collagen, and the anchor may be different owing to the fact that they are formed from different materials, sometimes resulting in the detachment of the anchor, which can move freely in the blood stream and become lodged in the lower extremities of the body, again requiring surgical removal.

It is worth noting that the prior art device, <CIT>, relies on clotting and is not a true vessel seal. <CIT> discloses an automatic tamping system that is usable on devices such as those described in <CIT> and <CIT>, to automate certain aspects of deployment, but it fails to provide a way for automatically severing the cinching suture and detaching the applicator from the implanted seal components. In addition the automatic tamping means is complex, adding cost and reducing reliability.

<CIT> provides a solution to many of these problems but does not allow for positive location of the vessel wall owing to the automatic nature of the device that deploys the seal assembly when the firing force is exceeded. This can occur when the assembly is retracted toward the vessel wall caused by friction of the inner lumen element dragging on the interior wall of the vessel, catching on plaque or other obstructions, resulting in embolization of the entire seal assembly and no hemostasis. In addition, the seal assembly of <CIT> does not provide for a feature to assure the sandwich force is consistent device to device, regardless of the patient's body mass index (BMI).

It would be desirable therefore to provide a vessel-sealing device that actually seals the blood vessel and does not rely on the clotting of the blood. It is also desirable to provide a closure device that is deployable through the catheter sheath with minimal steps requiring less than <NUM> minutes for hemostasis. It would be also desirable to provide a reliable vessel-sealing device the deployment efficacy of which is independent of the surgeon's feel, i.e. automatic deployment and automatic release of the seals from the deployment instrument.

<CIT> discloses a device according to the preamble of claim <NUM>.

<CIT> and <CIT> disclose other prior art.

The present invention is directed to a device for sealing an opening in the wall of a blood vessel according to claim <NUM>.

In some embodiments, the shaft is attached to at least one of the top and the bottom cover.

A predetermined force on the button may cause the arms to move out of the first groove and into the second groove.

Additional features and advantages of the invention will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the invention as described herein, including the detailed description which follows, the claims, as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description of the present embodiments of the invention, and are intended to provide an overview or framework for understanding the nature and character of the invention as it is claimed. The accompanying drawings are included to provide a further understanding of the invention, and are incorporated into and constitute a part of this specification. The drawings illustrate various embodiments of the invention and together with the description serve to explain the principles and operations of the invention.

Reference will now be made in detail to the present preferred embodiment(s) of the invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

Referring to <FIG> and <FIG>, closure device <NUM> is illustrated as having two handle halves <NUM>,<NUM> that house an automatic mechanism, described in more detail below, which is coupled to the seal assembly <NUM> by a flexible pusher rod <NUM> and a flexible shaft <NUM>. Seal assembly <NUM> has a first sealing element <NUM>, a knobbed rigid shaft <NUM>, an outer floating element <NUM>, and a second sealing element <NUM>. Knobbed, rigid shaft <NUM> has a proximal section <NUM> and a distal section <NUM> separated by a weakened notch feature <NUM>, which is configured to separate seal assembly <NUM> from the rest of the closure device <NUM> once the automatic deployment and sealing process is complete. The length of the distal section <NUM> of knobbed shaft <NUM> is dictated by the thickness of the blood vessel wall that can be accommodated. The first sealing element <NUM> also has a distal section <NUM> configured to interface with the inside wall of a vessel to be sealed, a knobbed, rigid distal shaft section <NUM> (which is a part of the knobbed, rigid shaft <NUM>), and ankle section <NUM> joining the distal section <NUM> to the knobbed, rigid distal shaft section <NUM>. The ankle section <NUM> is attached to distal section <NUM> at an angle ∝, which is preferably at an angle of about <NUM>°. Although other angles may be used, the value of angle ∝ may cause other values of the seal assembly to be changed, as discussed in detail below.

More detailed views of the first sealing element <NUM> and the knobbed rigid shaft <NUM> are illustrated in Figs. The first sealing element <NUM> has the distal section <NUM>, ankle section <NUM> and the knobbed, rigid distal shaft section <NUM>. The distal section <NUM> has a proximal or top surface <NUM>, a bottom surface <NUM> and an outer peripheral surface <NUM>. The proximal or top surface <NUM> is preferably configured to engage the interior wall surface <NUM> of the blood vessel <NUM> (see <FIG>), which means that the top surface <NUM> is preferably flat. However, the top surface <NUM> can be of any configuration (e.g., flat, convex, etc.). The bottom surface <NUM> is preferably flat, but may have other configurations. As noted below, the exact configuration of the surfaces <NUM>,<NUM> may also depend on the strain that is placed on them prior to and during insertion. The outer peripheral surface <NUM> is preferably continuous in that it has no discontinuities. That is, the outer peripheral surface <NUM> is smooth and has no sharp angles (e.g., <NUM>, <NUM> or <NUM>° angles). Since the distal section <NUM> is to be deformed prior to insertion into the blood vessel <NUM>, any sharp angles tend to create stress points, potentially causing the distal section <NUM> to be bent/deflected beyond its ability to return to its original configuration. The distal section <NUM> has a thickness that increases from the front (or distal) end <NUM> to the rear (or proximal) end <NUM>. In the embodiment illustrated in the figures, the thickness increases from <NUM> at the front end <NUM> to <NUM> at the rear end <NUM>. However, other thicknesses and tapered shapes may be used.

Second sealing element <NUM> is shown in more detail in <FIG>. The second sealing element <NUM> has a proximally facing surface <NUM> and a sloped distally facing surface <NUM>. An internal opening <NUM> defined by the internal surface <NUM> extends between the proximally facing surface <NUM> and the sloped distally facing surface <NUM>. The internal surface <NUM> has extending therefrom and into the internal opening <NUM> projections <NUM> that interface with and engage the knobs <NUM> with an interference fit such that second sealing element <NUM> and knobbed rigid shaft <NUM> function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness.

The internal opening <NUM> of second sealing element <NUM> (and floating foot <NUM>) have two flat surfaces <NUM> on opposite sides of the internal opening <NUM> that interface with flat surfaces <NUM>,<NUM> of knobbed rigid shaft <NUM> to provide rotational stability of the seal assembly components <NUM>,<NUM> thus assuring that the sloped distally facing surface <NUM> and the fully deployed floating foot <NUM> remain parallel with the distal section <NUM> of the first sealing element <NUM> and the proximal or top surface <NUM> in particular.

<FIG> and 6B depict introducer or outer sleeve <NUM>, which is configured to protect seal assembly <NUM> from damage when inserting seal assembly <NUM> through a hemostatic valve, which, as discussed below and in more detail in the co-pending application, is one method in which the seal assembly is inserted into the patient. Introducer <NUM> comprises two halves, <NUM>,<NUM>, which when assembled together form a generally cylindrical body having two different diameters. Front section <NUM> of introducer <NUM> has a smaller diameter than rear section <NUM>. Front section <NUM> with the smaller diameter is configured to be inserted into hemostatic valve and rear section <NUM>, having the larger diameter remains proximal to the hemostatic valve. While the two halves <NUM>,<NUM> can be assembled according to any typical manner, pins <NUM> on one of the two halves <NUM>,<NUM> are configured with a press fit into corresponding mating holes <NUM> thus holding halves <NUM>,<NUM> firmly together.

The introducer <NUM> has an opening <NUM> that extends between the front section <NUM> and the rear section <NUM>. However, within the opening <NUM> are also grooves <NUM> that are configured to accept seal assembly <NUM>. The opening <NUM> is also configured to receive at least a portion of pusher <NUM> of the seal device <NUM>. <FIG> is a cross section of seal assembly <NUM> in the initial position inside introducer <NUM> prior to insertion into a sheath <NUM>. The front end <NUM> and the rear end <NUM> of the distal portion <NUM> of first sealing element <NUM> are deformed into a configuration such that the distal portion <NUM> of first sealing element <NUM> is able to pass through the inside dimension of cannula <NUM> upon insertion of closure device <NUM> resulting in the configuration shown in <FIG>. After exit from distal end of cannula <NUM>, the front end <NUM> and the rear end <NUM> of the distal portion <NUM> of first sealing element <NUM> return to the initial configuration as shown in <FIG> owing to the configuration shown in <FIG> not exceeding the elastic limit of the material from which the seal assembly <NUM> is constructed.

Turning now to the main portion of the closure device <NUM> and referring to <FIG>, closure device <NUM> comprises two handle halves <NUM>, <NUM> that housing automatic mechanism <NUM>. The automatic mechanism <NUM> interfaces with safety latch <NUM>, which has a safety slide <NUM> that interacts with safety cage <NUM> via pin <NUM>. The safety latch <NUM> operates such that with safety slide <NUM> in the distal most position automatic mechanism <NUM> cannot be activated. The proximal most position of safety slide <NUM> allows automatic activation, explained in more detail below. The pin <NUM> is in the center of the underside of safety slide <NUM> and passes through handle opening <NUM> of handle half <NUM> and engages slot <NUM> of safety cage <NUM>. With the safety slide <NUM> in the full distal position, the pin <NUM> forces safety cage <NUM> into the position shown in <FIG> (to the left looking distally) such that leg <NUM> is forced into a slot <NUM> in pusher <NUM> that locks the movable pusher <NUM> against distal movement. The movement of the other parts of the automatic mechanism <NUM> are discussed in more detail below. In this position, safety slide <NUM> covers the word "READY" (or any other word, mark or appropriate indicia) and exposes the word "SAFE" (or any other word, mark or appropriate indicia) embossed on handle half <NUM>. In this position, the safety latch <NUM> prevents the automatic mechanism <NUM> from premature firing during shipment or handling. With safety slide <NUM> in the proximal-most position, the pin <NUM> forces safety slide <NUM> to the right, thus removing leg <NUM> from the slot <NUM> in pusher <NUM>. In this position the automatic mechanism <NUM> is free to initiate when first sealing element <NUM> interacts with the inside of vessel wall <NUM>. In this configuration safety slide <NUM> covers the word "SAFE" and exposes the word "READY" on handle half <NUM>.

Flexible pusher rod <NUM> is a cannulated cylinder, the proximal end of which is connected by an adhesive or by another appropriate method to the movable pusher <NUM>. The movable pusher <NUM> has a front portion <NUM> with an opening <NUM> for engagement with the flexible pusher rod <NUM> and to allow the flexible shaft <NUM> to pass through front portion <NUM>. The pusher <NUM> also has a rear portion <NUM> that is divided into an upper portion 176a and a lower portion 176b, the upper portion 176a and a lower portion 176b defining an opening <NUM> therebetween.

The automatic mechanism <NUM> also includes a shaft retaining element <NUM> that, in the initial or preactivation stage, is disposed in opening <NUM> defined by the upper portion 176a and a lower portion 176b of pusher <NUM>. The shaft retaining element <NUM> also has an opening <NUM> passing therethrough to allow the flexible shaft <NUM> to pass therethrough and extend proximally in the automatic mechanism <NUM>. However, the flexible shaft <NUM> is fixedly attached to the shaft retaining element <NUM>. The flexible shaft <NUM> therefore extends almost the entire length of the device <NUM>. As noted above, the flexible shaft <NUM> is also connected to the knobbed rigid shaft <NUM> of the seal assembly <NUM>. As explained below, a tensile force on the flexible shaft <NUM> causes the automatic mechanism <NUM> to fire.

The automatic mechanism <NUM> also has a spring <NUM>, which is illustrated as a cylindrical spring, but could be any resilient element and have any configuration. The spring <NUM> engages, at its proximal end, the proximal end of the handle <NUM>,<NUM>. The spring <NUM> is disposed around a spring retainer <NUM> and engages at its distal end, the front end <NUM> of the spring retainer <NUM>. The spring <NUM> is biased against the front end <NUM> of the spring retainer <NUM> to push the spring retainer <NUM> against the pusher <NUM>, as described in more detail below.

The automatic mechanism <NUM> also has two retention elements <NUM> that are rotatably mounted in the housing <NUM>,<NUM>. The two retention elements <NUM> are illustrated as being generally triangular, but could be of any shape or configuration as long as they perform the functions noted below. The retention elements <NUM> are disposed to engage the front end <NUM> of the spring retainer <NUM> and the shaft retaining element <NUM>. In fact, each of the two retention elements <NUM> engage a notch <NUM> on either side of the shaft retaining element <NUM>. The retention elements <NUM> each have an end portion <NUM>, preferably a flat surface, that engages an internal surface of the notches <NUM>. As can best be seen in <FIG>, the retention elements <NUM> are disposed on round projections <NUM> extending upward from the handle <NUM>. The projections <NUM> could also project downward from the handle <NUM>.

The use of the device <NUM> will now be described in conjunction with <FIG>. <FIG> and <FIG> are top views of the device with the upper handle half <NUM> and the safety latch <NUM> removed for clarity and to show pre-firing and post-firing, respectively. In <FIG>, the spring <NUM> is compressed by spring retainer <NUM>, which when released will provide the kinetic energy to seal the opening in the blood vessel and to break the knobbed rigid shaft <NUM>. The spring retainer <NUM>, and in particular the front end <NUM>, is biased against the retention elements <NUM>. The retention elements <NUM> cannot move due to the end portion <NUM> engaging the internal surface of the notches <NUM> of the shaft retaining element <NUM>. The front end <NUM> of spring retainer <NUM> is separated from the pusher <NUM> by the retention elements <NUM>. Keeping in mind that the shaft retaining element <NUM> is secured to the flexible shaft <NUM>, which in turn is secured to the knobbed rigid shaft <NUM>, pulling on the seal assembly <NUM> will cause the flexible shaft <NUM> to be pulled distally and move shaft retaining element <NUM> distally as well. This allows the retention elements <NUM> to rotate outward given the biasing of the front end <NUM> of the spring retainer <NUM>. The front end <NUM> of the spring retainer <NUM> can then push pusher <NUM> connected to the flexible pusher rod <NUM> distally. The effect of this movement is illustrated in <FIG>.

A method of using the device in conjunction with <FIG> is as follows: The device <NUM>, and in particular the seal assembly <NUM> is inserted into sheath introducer <NUM> that surrounds and deforms seal assembly <NUM> such that seal assembly seal <NUM> can pass through sheath valve <NUM>. See also <FIG>. The device <NUM> and sheath introducer <NUM> is inserted into a hemostatic valve for insertion into the patient. The device <NUM> preferably has a latch <NUM> that can be used to attach the device <NUM> to the sheath <NUM>. This allows for the simultaneous removal of the device <NUM> and the sheath <NUM>, if the sheath is not removed prior to the activation of the automatic mechanism <NUM>. Inserting pusher <NUM> through sheath <NUM>, including valve <NUM> and cannula <NUM>, causes at least a portion of seal assembly <NUM> to exit the distal end of cannula <NUM> and into blood vessel <NUM>. A portion of the second sealing element <NUM> and the pusher <NUM> may be disposed within the blood vessel <NUM>. The sheath <NUM> may then be removed from the device <NUM>. Pulling on the closure device <NUM>, the proximal or top surface <NUM> of the distal portion <NUM> of first sealing element <NUM> engages the interior blood vessel wall <NUM>. This would also remove the second sealing element <NUM>, the outer floating element <NUM>, and the pusher <NUM> from within the blood vessel <NUM>. Continuing to pull on the sealing assembly <NUM> and therefore flexible shaft <NUM> triggers the automatic mechanism <NUM> in the closure device <NUM>, which pushes pusher <NUM>, and which in turn pushes second sealing element <NUM>, and floating foot <NUM> distally such that floating foot <NUM> is in contact with outer wall of blood vessel <NUM>. This will sandwich the second sealing element <NUM> against floating foot <NUM>, blood vessel <NUM> and distal portion <NUM> of first sealing element <NUM> such that the opening in blood vessel <NUM> is hemostatically sealed, as shown in <FIG>.

The initial spring compression is chosen such that accounting for friction losses the remaining kinetic energy is sufficient to break weakened notch feature <NUM> of knobbed rigid shaft <NUM> resulting in the distal truncated portion of seal assembly <NUM> becoming detached from the rest of closure device <NUM> and also providing vessel hemostasis as shown in <FIG>. Note that as the user moves sheath <NUM> and closure device <NUM> proximally activating the automatic process and removes the two latched components, the handle and the sheath, from the body nothing remains in the patient except the bio-absorbable truncated portion of seal assembly <NUM>. Thus the entire closure process of sealing and disconnection is automatic requiring no "tactical feel" of the user.

Turning to another embodiment, a closure device <NUM> is illustrated in <FIG>, comprises two handle halves <NUM>, <NUM> housing an automatic mechanism.

More specifically and referring to <FIG>, closure device <NUM> comprises two handle halves <NUM>,<NUM> that housing automatic mechanism <NUM>. The automatic mechanism <NUM> interfaces with safety latch <NUM>, which has a safety slide <NUM> that interacts with safety cage <NUM> via pin <NUM>. The safety latch <NUM> operates such that with safety slide <NUM> in the distal most position automatic mechanism <NUM> cannot be activated. The proximal most position of safety slide <NUM> allows automatic activation. The pin <NUM> is in the center of the underside of safety slide <NUM> and passes through handle opening <NUM> of handle half <NUM> and engages slot <NUM> of safety cage <NUM>. With the safety slide <NUM> in the full distal position, the pin <NUM> forces safety cage <NUM> such that leg <NUM> is forced into a slot <NUM> in pusher <NUM> that locks the movable pusher <NUM> against distal movement. In this position, safety slide <NUM> covers the word "READY" (or any other word, mark or appropriate indicia) and exposes the word "SAFE" (or any other word, mark or appropriate indicia) embossed on handle half <NUM>. In this position, the safety latch <NUM> prevents the automatic mechanism <NUM> from premature firing during shipment or handling. With safety slide <NUM> in the proximal-most position, the pin <NUM> forces safety slide <NUM> to the right, thus removing leg <NUM> from the slot <NUM> in pusher <NUM>. In this position the automatic mechanism <NUM> is free to initiate when first sealing element <NUM> interacts with the inside of a vessel wall. In this configuration safety slide <NUM> covers the word "SAFE" and exposes the word "READY" on handle half <NUM>.

The automatic mechanism <NUM> also includes a shaft retaining element <NUM> that, in the initial or preactivation stage, is disposed in opening <NUM> defined by the upper portion 176a and a lower portion 176b of pusher <NUM>. The shaft retaining element <NUM> also has an opening <NUM> passing therethrough to allow the flexible shaft <NUM> to pass therethrough and extend proximally in the automatic mechanism <NUM>. However, the flexible shaft <NUM> is fixedly attached to the shaft retaining element <NUM>. The flexible shaft <NUM> therefore extends almost the entire length of the device <NUM>. As noted above, the flexible shaft <NUM> is also connected to the knobbed rigid shaft <NUM> of the seal assembly <NUM>. A tensile force on the flexible shaft <NUM> causes the automatic mechanism <NUM> to fire.

The automatic mechanism <NUM> also has two retention elements <NUM> that are rotatably mounted in the housing <NUM>,<NUM>. The two retention elements <NUM> are illustrated as being generally triangular but could be of any shape or configuration as long as they perform the functions noted below. The retention elements <NUM> are disposed to engage the front end <NUM> of the spring retainer <NUM> and the shaft retaining element <NUM>. In fact, each of the two retention elements <NUM> engage a notch <NUM> on either side of the shaft retaining element <NUM>. The retention elements <NUM> each have an end portion <NUM>, preferably a flat surface, that engages an internal surface of the notches <NUM>. The retention elements <NUM> are disposed on round projections <NUM> extending upward from the handle <NUM>. The projections <NUM> could also project downward from the handle <NUM>.

The automatic mechanism is coupled to the seal assembly <NUM> by a flexible pusher <NUM> and a flexible shaft <NUM>, as in the prior embodiment. Seal assembly <NUM> has a first sealing element <NUM>, a flexible member <NUM>, a knobbed rigid shaft <NUM>, an outer floating element <NUM>, and a second sealing element <NUM>. Knobbed, rigid shaft <NUM> has a proximal section <NUM> and a distal section <NUM> separated by a weakened notch feature <NUM>, which is configured to separate seal assembly <NUM> from the rest of the closure device <NUM> once the automatic deployment and sealing process is complete. The length of the distal section <NUM> of knobbed shaft <NUM> is dictated by the thickness of the vessel wall that can be accommodated. The first sealing element <NUM> also has a distal section <NUM> configured to, with the assistance of the flexible member <NUM>, interface with the inside wall of a vessel to be sealed; a knobbed, rigid distal shaft section <NUM> (which is a part of the knobbed, rigid shaft <NUM>); and ankle section <NUM> joining the distal section <NUM> to the knobbed, rigid distal shaft section <NUM>. The ankle section <NUM> is attached to distal section <NUM> at an angle ∝, which is preferably at an angle of about <NUM>°. Although other angles may be used, the value of angle ∝ may cause other values of the seal assembly to be changed. Applicant also notes the that the first sealing element <NUM> is formed with the distal section <NUM>, ankle section <NUM>, and the knobbed, rigid shaft <NUM> at the same time and from the same material. As such, the first sealing element <NUM> is an integrally formed element and the distal section <NUM> is not designed to move relative to the knobbed, rigid distal shaft section <NUM> at any time, except through deformity. As indicated in the parent patent, the first sealing element is preferably a one single-piece component.

A more detailed view of the first sealing element <NUM> and the knobbed rigid shaft <NUM> is presented in <FIG>. The first sealing element <NUM> has the distal section <NUM>, ankle section <NUM> and the knobbed, rigid distal shaft section <NUM>. The distal section <NUM> has a proximal or top surface <NUM>, a bottom surface <NUM> and a heel <NUM>. The top surface <NUM> can be of any configuration (e.g., flat, convex, etc). The bottom surface <NUM> is preferably flat, but may have other configurations as well. The heel <NUM> preferably has a greater thickness than the remainder of the distal section <NUM> and, as discussed below is disposed into a cavity in the inserter. The distal section <NUM> has a thickness that increases from the front (or distal) end <NUM> to the rear (or proximal) end <NUM>. In the embodiment illustrated in the figures, the thickness increases from <NUM> at the front end <NUM> to <NUM> at the rear end <NUM>. However, other thicknesses and tapered shapes may be used.

A top view of the knobbed, rigid shaft <NUM> and the first sealing element <NUM> is illustrated in <FIG>. The knobbed, rigid shaft <NUM> has a proximal end <NUM> that may be connected to the flexible shaft <NUM> in any appropriate fashion, e.g., glued, soldered, press-fit, friction fit, etc. Alternatively, the flexible shaft <NUM> may also be integral with the knobbed, rigid shaft <NUM>, i.e., be formed at the same time with the same material making it an "integral" piece. The knobbed, rigid shaft <NUM> has knobs <NUM> along the upper surface <NUM> and the lower surface <NUM>. The knobbed, rigid shaft <NUM> also has opposite sides <NUM>,<NUM>, each side of which includes a groove <NUM> that runs along the length of the knobbed, rigid shaft <NUM> between the ankle section <NUM> and the proximal end <NUM>. The grooves <NUM> are preferably rectangular (or square) in cross section for reasons that will become apparent below. As such each of the grooves <NUM> have a front (or first) surface <NUM> and a rear (or second) surface <NUM>. It is noted that the front surface <NUM> faces the rear portion of the knobbed, rigid shaft <NUM>, while the rear surface <NUM> faces the front of the knobbed, rigid shaft <NUM>. The grooves <NUM> cooperate with the other portions of the seal assembly <NUM> to ensure that the outer floating element <NUM> and the second sealing element <NUM> are properly positioned, as discussed in more detail below. Since the grooves <NUM> are smaller than the sides <NUM>,<NUM>, the sides <NUM>,<NUM> present a flat surface for the outer floating element <NUM>, discussed below.

Illustrated in <FIG> is a cross section of the knobbed, rigid shaft <NUM> at the weakened notch feature <NUM>. The weakened notch feature <NUM> has a smaller cross section than any other portion of the knobbed rigid shaft <NUM>. This allows for the knobbed, rigid shaft <NUM> to be broken at this point upon activation of the insertion device <NUM> by exerting a force in the direction of the length of the knobbed, rigid shaft <NUM>, causing the knobbed, rigid shaft <NUM> to break at the weakened notch feature <NUM>. In order to prevent the weakened notch feature <NUM> from breaking prematurely, a c-shaped ring may be clipped into the weakened notch feature <NUM> as noted above. The width of notch feature <NUM> is sized to equal the space between knobs <NUM> so that second seal <NUM> can easily transition over notch feature <NUM> upon automatic activation of device <NUM>. The c-shaped ring prevents the knobbed, rigid shaft <NUM> from being tilted off center and breaking prematurely.

In <FIG>, the groove <NUM> in the knobbed, rigid distal shaft section <NUM> preferably flares outward at 372a at the weakened notch feature <NUM>, to ensure that the outer floating element <NUM> and its components float over the weakened notch feature <NUM> during operation without skiving on a portion of the groove <NUM> at that location.

The flexible member <NUM>, along with distal section <NUM>, assists in sealing the opening in the vessel wall. The flexible member <NUM> is illustrated as being a circular member having an opening <NUM> in a middle portion thereof. The flexible member <NUM> has a thickness t, which is preferably around <NUM> millimeters. Since the flexible member <NUM> is preferably made from <NUM>% L-lactide <NUM>% caprolactone copolymer, it is able to being deformed as described below. As illustrated in <FIG> and <FIG>, the flexible member <NUM> is disposed around the ankle portion <NUM> and against the top surface <NUM> of the distal section <NUM>. Preferably, the flexible member <NUM> is attached to the top surface <NUM> of the distal section <NUM>. It can be attached in any number of ways, including heat-staking or welding the flexible member <NUM> to the top surface <NUM>, using an approved adhesive between the flexible member <NUM> and the top surface <NUM> flexible member <NUM>. Alternatively, the opening <NUM> could be slightly smaller than the diameter of the ankle portion <NUM>, preventing the flexible member <NUM> from moving along the length of the knobbed, rigid shaft <NUM> at the ankle portion <NUM>. As explained in more detail below, the flexible member <NUM> is disposed between the distal section <NUM> and the inner wall of the vessel. See, e.g., <FIG>.

While the opening <NUM> is a contained opening, it is also possible that there be a slit (or small path) from the outside of the flexible member <NUM> allowing the flexible member to be disposed around the ankle portion <NUM> without having to slide it the length of the knobbed, rigid shaft <NUM>.

Second sealing element <NUM> is shown in more detail in <FIG> and is the same as that illustrated in <FIG>. The second sealing element <NUM> has a proximally facing surface <NUM> and a sloped distally facing surface <NUM>. An internal opening <NUM> defined by the internal surface <NUM> extends between the proximally facing surface <NUM> and the sloped distally facing surface <NUM>. The internal surface <NUM> has extending therefrom and into the internal opening <NUM> projections <NUM> that interface with and engage the knobs <NUM> with an interference fit such that second sealing element <NUM> and knobbed, rigid shaft <NUM> function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness.

Referring to <FIG>, the internal opening <NUM> of second sealing element <NUM> have two flat surfaces <NUM> on opposite sides of the internal opening <NUM> that interface with flat surfaces <NUM>,<NUM> of knobbed rigid shaft <NUM> to provide rotational stability of the seal assembly components <NUM>,<NUM>, thus assuring that the sloped distally facing surface <NUM> and the fully deployed outer floating foot <NUM> remain parallel with the distal section <NUM> of the first sealing element <NUM> and the proximal or top surface <NUM> in particular.

The outer floating element <NUM> is illustrated in detail in <FIG>. The outer floating element <NUM> is generally rectangularly shaped and has a rectangularly shaped central aperture <NUM> and two protrusions <NUM> that extend from the longest side walls <NUM> into the aperture <NUM>. The outer floating element <NUM> has a top surface <NUM> and a bottom surface <NUM>, which are generally parallel to one another. The protrusions <NUM> are configured to engage and allow the outer floating element <NUM> to travel along the knobbed, rigid shaft <NUM> in the grooves <NUM>. The protrusions are somewhat tear drop shaped, but have two flat surfaces, a first flat surface <NUM> and a second flat surface <NUM>. The outer floating element <NUM> also has two inclined surfaces <NUM> and <NUM>, one at either end of the outer floating element <NUM> and defines the ends of the aperture <NUM>. The first flat surface <NUM> is at an angle ß relative to the top and bottom surfaces <NUM>,<NUM> of outer floating element <NUM>. See Fig. 23A. Preferably angle β is about a <NUM> degree angle but could be anywhere between <NUM> and <NUM> degrees. The second flat surface <NUM> makes an angle γ relative to the top and bottom surfaces <NUM>,<NUM>. Preferably angle γ is about a <NUM> degree angle but could be anywhere between <NUM> and <NUM> degrees. As would be obvious, the two inclined surfaces <NUM> and <NUM> are also parallel to the second flat surface <NUM> as will be explained below.

Turning to <FIG>, the positioning of the outer floating element <NUM> will be explained. In both figures, the dotted lines correspond to the surfaces of the knobbed, rigid shaft <NUM> presented to the outer floating element <NUM>. In particular, the two middle lines correspond to the front (or first) surface <NUM> and the rear (or second) surface <NUM> of the groove <NUM>. Thus, the two protrusions <NUM> will slide along between those two middle lines. The two outside lines correspond to the upper <NUM> surface and the lower <NUM> surface of the outer floating element <NUM>. In <FIG>, the outer floating element <NUM> is illustrated in its stored version - to be inserted into, or already in the inserter. Thus, in the position of <FIG>, the outer floating element <NUM> has, relative to the rest of the seal assembly <NUM>, the smallest profile and will allow it to pass through a smaller cannula.

<FIG> illustrates the outer floating element <NUM> relative to the knobbed, rigid shaft <NUM> after it exits the cannula. That is, the outer floating element <NUM> has been engaged by the second sealing element <NUM> (not shown in the figures) and because the size of the projections <NUM> relative to the groove <NUM>, the outer floating element <NUM> can rotate (clockwise in <FIG>) relative to the knobbed, rigid shaft <NUM> to be in a position to engage the outside of the vessel. See, e.g., <FIG>.

An inserter <NUM> is illustrated in <FIG>. The embodiment of the inserter <NUM> illustrated has a first portion <NUM> and a second portion <NUM>, which are illustrated as a top half and a bottom half. Naturally, the portions <NUM>,<NUM> could have other names (e.g., side portions)and still fall within the scope of the present invention. The inserter <NUM> has a proximal end <NUM> and a distal end <NUM>. When the portions <NUM>,<NUM> are assembled, a longitudinal opening <NUM> is created that extends through the inserter <NUM>. The inserter <NUM> preferably has at the proximal end <NUM> a proximal section <NUM> that has a constant diameter outer surface and a constant diameter for the longitudinal opening <NUM> at the proximal section <NUM>. The proximal section <NUM> of each of the portions <NUM>,<NUM> has a number of projections <NUM> and openings <NUM>. The projections <NUM> of one portion <NUM>,<NUM> correspond to the openings <NUM> of the other portion <NUM>,<NUM>, thereby allowing the two portions <NUM>,<NUM> to be brought together and aligned for use. Forward of the proximal section <NUM> is a reduced diameter area <NUM>, which then increases in diameter at <NUM> creating a shoulder <NUM> before tapering back down to a smaller outer diameter at the distal end <NUM>.

The longitudinal opening <NUM> in inserter <NUM> allows for the seal assembly <NUM> to be loaded therein, sterilized, stored, and then used by a doctor. Typically, if a seal assembly is contained within a confined space and then sterilized, the sterilization causes the seal assembly to maintain the configuration in which it is sterilized. Even if the material normally was some shape memory (allowing the material to spring back to its original shape or configuration), the sterilization has been found by the inventor to prevent the materials from returning to their original configuration. Thus, the current inserter <NUM> allows for the seal assembly <NUM> to be loaded without any real change in configuration. The longitudinal opening <NUM> has been designed to hold the first sealing element <NUM>, a flexible member <NUM>, a knobbed rigid shaft <NUM>, an outer floating element <NUM>, and a second sealing element <NUM> without this issue. To do so, however, the portion <NUM> has an aperture <NUM> to allow for the heel <NUM> of the distal section <NUM> to be disposed therein. While the aperture <NUM> is illustrated as extending through the portion <NUM>, it is possible that there only be a depression, groove, or dimple that does not penetrate all the way through the portion <NUM>.

Turning to <FIG>, a cross section of the inserter <NUM> with the seal assembly <NUM> disposed therein illustrates the position of the seal assembly <NUM> within the inserter <NUM>. As should be clear, the cross section is through the center of both portions <NUM>,<NUM>. It should also be noted that the distance D1 of between the two portions <NUM>,<NUM> of the longitudinal opening <NUM> is generally constant. The position of the outer floating element <NUM> relative to the knobbed, rigid shaft <NUM> and the position of the flexible member <NUM> relative to the distal section <NUM> allow the inserter to have a minimum size.

<FIG> illustrates the seal assembly <NUM> within the inserter <NUM> from above the inserter <NUM>. In this view, it is clear that the diameter D2 of the longitudinal opening <NUM> is larger in the horizontal plane; allowing the flexible member <NUM> to hold its original configuration. The longitudinal opening <NUM> at the proximal section <NUM> is also sized to allow the outer floating element <NUM> and the second sealing element <NUM> to pass therethrough. The longitudinal opening <NUM> at the distal end <NUM> is smaller than the diameter D2, but the flexible member <NUM> and the distal section <NUM> can be deformed and then return to their original shape for use in the patient.

A method of using the device in conjunction with <FIG> is as follows: The device <NUM>, and in particular the seal assembly <NUM> is inserted into inserter <NUM> that surrounds seal assembly <NUM> such that seal assembly <NUM> can pass through sheath valve <NUM> and to the sheath <NUM>. This allows for the simultaneous removal of the device <NUM> and the sheath <NUM>, if the sheath is not removed prior to the activation of the automatic mechanism. Inserting pusher <NUM> through sheath <NUM>, including valve <NUM> and cannula <NUM>, causes at least a portion of seal assembly <NUM> to exit the distal end of cannula <NUM> and into blood vessel <NUM>. The sheath <NUM> may then be removed from the device <NUM>. Pulling on the closure device <NUM>, the flexible member <NUM> and the distal portion <NUM> of first sealing element <NUM> engages the interior blood vessel wall <NUM>. This would also remove the second sealing element <NUM>, the outer floating element <NUM>, and the pusher <NUM> from within the blood vessel <NUM>. Continuing to pull on the sealing assembly <NUM>, and therefore flexible shaft <NUM>, triggers the automatic mechanism <NUM> in the closure device <NUM>, which pushes pusher <NUM>, and which in turn pushes second sealing element <NUM>, and the outer floating element <NUM> distally such that the outer floating element <NUM> is in contact with outer wall of blood vessel <NUM>. This will sandwich the outer floating element <NUM>, the blood vessel <NUM> and the flexible member <NUM> between the first and second sealing elements <NUM>, <NUM> such that the opening in blood vessel <NUM> is hemostatically sealed, as shown in <FIG>.

An embodiment of a closure device <NUM> according to the invention is illustrated in <FIG>. In this embodiment, the closure device <NUM> is not automatic, but a semiautomatic device to seal the vessel. The closure device <NUM> has a top cover <NUM> and a bottom cover <NUM> that are connected to one another. The top cover <NUM> and the bottom cover <NUM> house the pushing assembly <NUM>. The pushing assembly <NUM> includes a pushing rod <NUM>, a pusher <NUM> and a button <NUM>. As explained in more detail below, the button <NUM> is used to move the pusher <NUM>, which is fixedly attached to the pushing rod <NUM>, to activate the seal assembly <NUM>.

The seal assembly <NUM> may be and is preferably the same as the seal assembly <NUM> discussed in detail above with regard to <FIG>. As is visible in <FIG>, the seal assembly <NUM> has a first sealing element <NUM>, a flexible member <NUM>, a knobbed rigid shaft <NUM>, an outer floating element <NUM>, and a second sealing element <NUM>. It is possible that the first sealing element <NUM> and the flexible member <NUM> are a single element - that is a one single-piece component. There may be other configurations of the seal assembly as well, as discussed above. Also in <FIG> is a cross section of the knobbed, rigid shaft <NUM> at the weakened notch feature <NUM>. The weakened notch feature <NUM> has a smaller cross section than any other portion of the knobbed rigid shaft <NUM>. This allows for the knobbed, rigid shaft <NUM> to be broken at this point upon activation of the closure device <NUM>, as discussed in more detail below, by exerting a force in the direction of the length of the knobbed, rigid shaft <NUM>, causing the knobbed, rigid shaft <NUM> to break at the weakened notch feature <NUM>. In order to prevent the weakened notch feature <NUM> from breaking prematurely, a c-shaped ring may be clipped into the weakened notch feature <NUM> as noted above. The width of notch feature <NUM> is sized to equal the space between knobs <NUM> so that second seal <NUM> can easily transition over notch feature <NUM> upon activation of device <NUM>. The c-shaped ring prevents the knobbed, rigid shaft <NUM> from being tilted off center and breaking prematurely.

Referring to <FIG> the structure of the pushing assembly <NUM> will be discussed. The pusher <NUM> has an opening <NUM> that receives and can have secured therein the pushing rod <NUM>. Thus, as the pusher <NUM> is moved, so too is the pushing rod <NUM>. The pusher <NUM> has a foot <NUM> that extends in a forward direction (toward the seal assembly <NUM>) and is connected by a central portion <NUM> to two arms 520a and 520b. Each of the arms 520a and 520b has a top surface 522a and 522b, respectively. The pusher <NUM> also has a button extension <NUM> that can receive the button <NUM>. As noted in the figures, the surface 522a and 522b of the arms 520a, 520b are perpendicular to the foot <NUM>.

Turning to <FIG>, the bottom cover <NUM> has a central channel <NUM> in which the foot <NUM> of the pusher <NUM> can slide or ride in during operation. The bottom cover <NUM> has a plurality of ribs <NUM> to provide structural integrity that extend from the inside surface <NUM>. There are also posts <NUM> to support the top cover <NUM>.

The top cover <NUM> is illustrated in more detail in <FIG>. The top cover <NUM> has a plurality of ribs <NUM> also to provide structural integrity and a number of post receptacles <NUM> to receive the posts <NUM> from the bottom cover <NUM>. These structures are preferably attached to the inside surface <NUM>. The top cover <NUM> also includes a top cover opening <NUM> through which the button extension <NUM> and button <NUM> project to the outside of the top cover <NUM>. Extending outwardly to the sides of the top cover <NUM> and on either side of the top cover opening <NUM> are slots 546a to receive the top surfaces 522a and 522b of the two arms 520a and 520b. There are another two slots 546b at the other end of the opening <NUM>. As noted, there are four such slots (two of 546a and two of 546b) in the illustrated top cover <NUM>. However, there could just be two slots, one at each end of the top cover opening <NUM> in the top cover <NUM>, rather than the two that are illustrated at each end of the top cover opening <NUM>.

The top cover <NUM> also includes a slot <NUM> to support a shaft <NUM> that is connected to the seal assembly <NUM> as illustrated as discussed above. The shaft <NUM> (see <FIG>) can be secured to the slot <NUM> as well as a second slot <NUM> at the rear end of the top cover <NUM>. Corresponding thereto is also a slot <NUM> at the back end of the bottom cover <NUM>.

Returning to <FIG> and <FIG>, there are four holes <NUM> in the top cover <NUM> that function as an indicator as to the position of the two arms 520a and 520b. Since the holes <NUM> are at the end of the slots 546a and 546b, it is possible to know where the two arms 520a and 520b are before using the device <NUM>. Additionally, the four holes <NUM> need not be at the end of the slots 546a, 546b, but could be anywhere along the slots as long as they are not blocked by the button <NUM>.

Having described the components, the operation of the device <NUM> will now be explained. First, it is noteworthy that the interior space between the top cover <NUM> and the bottom cover <NUM> is slightly less than the relaxed position of the pusher <NUM>. Thus, when the pusher <NUM> is secured within the device <NUM>, there is a slight compression of the pusher <NUM> - pushing the arms 520a and 520b toward the foot <NUM>. When the pusher <NUM> is aligned with the slots 546a and 546b, the arms 520a and 520b are biased into the slots 546a, 546b. To move the button <NUM> and the entire pushing assembly <NUM> forward, the user must push down and forward on the button <NUM>. Some force will be needed to move the arms 520a and 520b out of the first set of slots 546a. The pushing assembly <NUM> will move forward to the second set of slots 546b, moving the pushing rod <NUM> and the second portion (second sealing element <NUM>) of the seal assembly <NUM> toward the first portion (first sealing element <NUM>). As the second portion of the seal assembly <NUM> is pushed toward the first portion and sandwiches the blood vessel between the first and second portions of the seal assembly <NUM>, there be an increased force required to push the pushing assembly <NUM> toward the first portion of the seal assembly <NUM>. When that force equals the force required to break the knobbed, rigid shaft <NUM> at the weakened notch feature <NUM>, the device <NUM> will be separated from the seal assembly - preventing any more pressure from being applied to the seal assembly <NUM>. Thus, the force applied to sealing the blood vessel is controlled and limited by the force required to break the knobbed, rigid shaft <NUM>. As a result, the amount of pressure applied to sealing the blood vessel is tightly controlled by the design of the weakened notch feature <NUM>. Thus, too much pressure cannot be applied to seal assembly and if too little pressure is applied, then the device <NUM> cannot be removed until the required amount of pressure is applied.

It should also be noted that the second set of slots 546b will stop the movement of the pushing rod <NUM>, which coincides with the distance that the pushing rod <NUM> and the second portion of the seal assembly <NUM> must move to seal the blood vessel. See <FIG> showing the movement of the pushing assembly <NUM>.

Claim 1:
A device (<NUM>) for sealing an opening in the wall of a blood vessel (<NUM>), the blood vessel (<NUM>) having an interior wall surface (<NUM>), exterior wall surface, and a lumen, the device (<NUM>) comprising:
a pushing rod (<NUM>), the pushing rod (<NUM>) having an opening therealong;
a shaft (<NUM>) disposed within at least a portion of the opening of the pushing rod (<NUM>);
a pusher (<NUM>), the pusher (<NUM>) fixedly attached to the pushing rod (<NUM>);
a bottom cover (<NUM>) and a top cover (<NUM>), a button (<NUM>) extending through the top cover (<NUM>) and engaging the pusher (<NUM>); and
a seal assembly (<NUM>) having a first portion and a second portion, the seal assembly (<NUM>) operatively attached at the first portion to the distal end of the shaft (<NUM>), the seal assembly (<NUM>) configured to engage the interior wall surface and the exterior wall surface of the blood vessel (<NUM>),
wherein the pushing rod (<NUM>) operatively engages the seal assembly (<NUM>) at the second portion and is movable relative to the shaft (<NUM>), the pushing rod (<NUM>) moving from a first position to a second position in response to the button (<NUM>) moving distally causing the first portion and the second portion of the seal assembly (<NUM>) to move relative to one another, characterized in that
the top cover (<NUM>) has a top cover opening (<NUM>) through which the button (<NUM>) passes,
the pusher (<NUM>) has a foot (<NUM>) and two arms (520a, 520b), the arms (520a, 520b) engaging a first groove (546a) in the top cover (<NUM>, <NUM>) at a proximal end of the top cover opening (<NUM>, <NUM>) in a first status and a second groove (546b) in the top cover (<NUM>, <NUM>) at a distal end of the opening (<NUM>, <NUM>) in a second status.