Patent Description:
During the use of vascular closure systems after vascular interventions, it is often important to know the location of a puncture in the vessel, and in particular, providing for exact placement of vascular sheaths. Typically, a "blood flashback" method is used to position a vascular device. <CIT> discloses a hemostatic device for sealing a puncture of a vessel includes a first tube defining a first lumen. The first lumen is configured to receive a guidewire and a flow of a fluid therethrough. The hemostatic device also includes a second tube circumscribing at least a portion of the first tube and at least partially defining a second lumen. The hemostatic device further includes a substantially rigid stopper coupled to a distal end of the second tube. The stopper defines a stopper lumen that receives the first tube therethrough in an interference fit. A first opening is defined in a side wall of the first tube and positioned distally relative to the stopper. At least one injection groove defined in an outer surface of the stopper cooperates with the distal end of the second tube to define at least one second opening in flow communication with the second lumen. <CIT> discloses a medical device including a sheath having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end, and a removable dilator having a distal end and a proximal end, the dilator having at least one blood detector disposed on a tapered portion of the distal end of the dilator, the dilator positionable within the sheath such that the tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath, the proximal end of the dilator extends through the opening in the proximal end of the sheath, and at least a portion of the at least one blood detector is adjacent to the distal end of the sheath.

An embodiment of the present invention, as disclosed in the appended independent claim <NUM>, includes a puncture locating device for locating a puncture in a blood vessel. The puncture locating device includes an elongated dilator having a distal end, a proximal end that is opposite the distal end, an outer surface, an internal channel that extends from the distal end to the proximal end, an inlet opening that is open to the internal channel and is spaced from the distal end, and an outlet opening disposed between the proximal end and the inlet opening. The dilator also includes a flexible barrier attached to the elongated dilator and overlying the outlet opening so that the flexible barrier and the outer surface proximate the outlet opening at least partially define an internal volume. The flexible barrier is configured to be movably responsive to pulsatile blood flow, such that, when the elongated dilator is inserted into the puncture of the blood vessel, blood flows into the inlet opening through the channel and out the outlet opening into the internal volume, such that, pulsations in the blood flow cause the flexible barrier to pulse, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel.

The foregoing summary, as well as the following detailed description of example embodiments of the application, will be better understood when read in conjunction with the appended drawings, in which there is shown in the drawings example embodiments for the purposes of illustration. It should be understood, however, that the application is not limited to the precise systems and methods shown. In the drawings:.

Certain terminology is used in the following description for convenience only and is not limiting. The words "right", "left", "lower" and "upper" designate directions in the drawings to which reference is made. The words "proximally" and "distally" refer to directions toward and away from, respectively, the individual operating the system. The terminology includes the above-listed words, derivatives thereof and words of similar import.

Referring to <FIG>, a puncture locating system <NUM> includes an elongated dilator <NUM> and an access sheath <NUM> used in locating a puncture in a vessel during or along with an interventional cardiovascular procedure. Typically, before an interventional cardiovascular procedure, a puncture may be made in the femoral artery. In one example, a vascular closure device composed of an absorbable anchor, a folding sealing plug, a suture and a downward locking member have been developed and may be used to seal these punctures. However, before sealing can occur the depth at which the device needs to be inserted must be attained. Currently, the procedure is conducted with a puncture locator comprising of two inlet holes towards the distal end and one outlet opening at the proximal end. Conventional puncture locators allow blood to flow through the dilator and out an outlet opening when the inlet hole is present within the circulatory tract. The present disclosure, however, includes embodiments of puncture location system comprising an elongated dilator <NUM> with a blood pulsation indicator <NUM>, as will be further explained below.

Referring to <FIG>, the elongated dilator <NUM> is configured to locate a puncture site <NUM> (<FIG>) in a vessel <NUM> with the blood pulsation indicator <NUM>. The elongated dilator <NUM> includes a dilator body <NUM> that is elongated along a central longitudinal axis A in a first direction L. The first direction may be referred to as a longitudinal direction in this disclosure. The dilator body <NUM> defines a proximal end 35p and a distal end 35d that is spaced from the proximal end 35p along the first direction L. The distal end 35d of the dilator may be tapered to facilitate entry into the vessel. The dilator body further defines an inner surface <NUM>, which may define an internal guide channel <NUM>, and an outer surface <NUM> (<FIG>). The elongated dilator <NUM> is configured to be moved along a guidewire <NUM> toward the puncture site <NUM> such that the elongated dilator <NUM> enters the vessel <NUM> through the puncture site <NUM>. As the elongated dilator <NUM> enters the vessel <NUM> the elongated dilator <NUM> dilates the puncture site <NUM>.

The elongated dilator is sized for a range of procedures. In one embodiment, the outer surface <NUM> defines an outer cross-sectional dimension that is substantially perpendicular to the central longitudinal axis A and the outer cross-sectional dimension is at least about <NUM>. In one example, the outer cross-sectional dimension is at least about <NUM> - <NUM>. However, dimensions outside of this range are possible.

Referring to <FIG>, the internal guide channel <NUM> that extends through the dilator body <NUM> along the first direction L from the distal end 35d through to the proximal end 35p. The internal guide channel <NUM> is configured to receive the guidewire <NUM> such that the elongated dilator <NUM> can be moved along the guidewire <NUM> toward the puncture site <NUM>. The internal guide channel <NUM> at the distal end 35d and proximal end 35p can have a diameter that is substantially equal to that of the guidewire <NUM> so that the elongated dilator <NUM> can move along the guidewire <NUM> in a controlled manner.

Referring to <FIG>, the dilator <NUM> can further define a blood inlet hole <NUM> and a blood outlet opening <NUM>. The blood inlet hole <NUM> that extends through the dilator body <NUM> along a direction that is transverse to the first direction L. The blood outlet opening <NUM> that extends through the dilator body <NUM> proximal to the blood inlet hole <NUM>. The blood inlet hole <NUM> and the blood outlet opening <NUM> are in fluid communication with each other such that when the blood inlet hole <NUM> enters the vessel <NUM>, blood from the vessel <NUM> will enter the blood inlet hole <NUM> and exit the blood outlet opening <NUM> into the blood pulsation indicator <NUM>, to thereby indicate that the blood inlet hole <NUM> has entered the vessel <NUM>, as further explained below. In the illustrated embodiment, the blood inlet and outlet openings <NUM> and <NUM> extend into the guide channel <NUM> such that blood entering the blood inlet hole <NUM> will travel through the guide channel <NUM>, around the guidewire14, and out the blood outlet opening <NUM> into the blood pulsation indicator <NUM>. It should be appreciated, however, that in some embodiments, the guide channel <NUM> and the channel through which the blood flows can be separate and distinct from each other, as desired. In particular, the guide channel <NUM> is sized to have a tight fit around the guidewire.

As shown in <FIG>, the blood pulsation indicator <NUM> is used to locate the puncture. More specifically, the blood pulsation indicator <NUM> is configured to be responsive to presence of pulsatile blood flow inside the dilator <NUM> when the inlet hole is located inside the vessel. As shown, the blood pulsation indicator <NUM> includes a flexible barrier <NUM> attached to the elongated dilator <NUM> and overlying the outlet opening <NUM>. Configured this way, the flexible barrier <NUM> and the outer surface <NUM> proximate the outlet opening <NUM> at least partially defines an internal volume IV. When the elongated dilator <NUM> is inserted into the puncture <NUM> of the blood vessel <NUM>, blood flows into the inlet opening <NUM> through the outlet opening <NUM> into the internal volume IV such that, pulsations in the blood flow cause the flexible barrier <NUM> to pulse, thereby generating a visual and tactile indication of presence of the inlet opening <NUM> in the blood vessel <NUM>.

The flexible barrier <NUM> may be formed from a polymeric material that is flexible, yet durable enough to withstand pulsatile flow. For example, the flexible barrier may be polyvinylchloride, polyethylene, polyurethane, polyamides, and/or copolymer thereof. The flexible barrier can be planar shape, a sleeve, or form part of pocket, pouch, bag or other structure that can enclose a fluid.

The flexible barrier <NUM> may overlie the outlet opening to form an internal volume. In the illustrated embodiment, as shown in <FIG>, attachment members <NUM> and <NUM> secure the flexible barrier in place on the dilator body <NUM>. In one example, the flexible barrier may only overlie a portion of the dilator body <NUM>. In other configurations, the flexible barrier may be in form of a sleeve that surrounds an entirety of the dilator body <NUM> proximate the outlet opening <NUM>.

The blood pulsation indicator <NUM> may have configurations other than what is specifically illustrated. For example, in one alternative embodiment, the flexible barrier may be part of a flexible container that is attached to the elongated dilator. For instance, the flexible container may be flexible bag or bladder attached to the dilator.

In addition, the dilator may further comprise a handle member disposed on the elongated dilator. In such an embodiment, the elongated dilator includes a port disposed in the outlet opening <NUM>. The flexible barrier is attached to the handle member such that the port extends from the elongated dilator to the flexible barrier.

Now, in reference to <FIG>, the elongated dilator <NUM> can further include a plurality of depth markings <NUM> spaced from each other along the first direction L between the inlet opening <NUM> and outlet opening <NUM>. The depth markings <NUM> can be used to visually note the depth or otherwise the location of the puncture site <NUM> of the vessel <NUM> when the elongated dilator <NUM> has been positioned within the vessel. In the illustrated embodiment, the depth markings <NUM> are numbers on the dilator body <NUM>. It should be appreciated, however, that the depth markings <NUM> can have other configurations as desired. For example, the depth markings can be configured as symbols as desired. The depth markings <NUM> can be used to locate the puncture site <NUM>. That is, after a position of the puncture site <NUM> has been located with the blood inlet hole <NUM>, a position of a first visible marking of the plurality of depth markings <NUM> on the dilator that is adjacent the patient's skin can be noted when the blood flows. Therefore, the position of the puncture site <NUM> can be known for the remainder of the procedure. The noted first marking can be noted with a sticker that is placed directly on the patient's skin as desired. It should be appreciated, however, that the first depth marking can be noted using other configurations as desired. For example, the first depth marking can be noted with a tag, card, clip, etc. In an alternative embodiment, the depth markings of this embodiment can either be used alone or in combination with the radiopaque markers.

The puncture sealing system <NUM> can further include an access sheath <NUM> that is also configured to be moved along the guidewire <NUM> toward the puncture site <NUM> and into the vessel <NUM> so as to further dilate the puncture site <NUM> and subsequently provide access to the vessel <NUM>. The access sheath <NUM> can then receive a vascular sealing device <NUM> that is configured to seal the puncture site <NUM>. It should be appreciated, however, that the system can include additional dilators that have cross-sectional diameters that are different (e.g. greater) than the diameter of the locating dilator <NUM> but less than that of the access sheath <NUM> so that the puncture site <NUM> can be gradually dilated and prepared for the access sheath <NUM>. Both the locating dilator <NUM> and the access sheath <NUM> include respective depth markings that are configured to aid in locating the puncture site <NUM>, as will be further described below.

Now referring to <FIG>, the access sheath <NUM> includes a sheath body <NUM> that is elongate along the first direction L and a sheath dilator <NUM> that is coupled within an access channel <NUM> of the sheath body <NUM>. The access channel <NUM> extends through the sheath body <NUM> from a proximal end through to a distal end of the sheath body <NUM> and is configured to provide an access path to the puncture site <NUM> after the sheath dilator <NUM> has been removed from the access channel <NUM>. The access sheath <NUM>, like the elongated dilator <NUM>, is configured to be moved along the guidewire <NUM> toward the puncture site <NUM> such that the distal end of the access sheath <NUM> enters the vessel <NUM>.

With continued reference to <FIG>, the access sheath <NUM> further includes a plurality of depth markings <NUM> spaced from each other along the first direction L on the sheath body <NUM>. The depth markings <NUM> correspond to the depth markings <NUM> on the elongated dilator <NUM> such that as the access sheath <NUM> is inserted into the vessel <NUM> the location of the distal end of the access sheath <NUM> relative to the puncture site <NUM> can be known because of the depth markings <NUM>. In the illustrated embodiment, the depth markings <NUM> are numbers. It should be appreciated, however, that the depth markings <NUM> can have other configurations as desired so long as they somehow correspond to the depth markings <NUM>. The depth markings <NUM> can be used to position the sheath body <NUM> so that a closure device <NUM> that is to be moved into the access channel <NUM> will be properly positioned for sealing of the puncture site <NUM>. For example, the sheath body <NUM> can be positioned such that a first marking of the depth markings <NUM> that corresponds to the noted first visible marking on the dilator <NUM> is the first visible marking on the access sheath <NUM>. When the first visible marking of the access sheath <NUM> corresponds to the noted first visible marking on the elongated dilator <NUM>, the appropriate amount of sheath body <NUM> will be disposed within the vessel <NUM>. It should be appreciated, however, that in some embodiments, the depth markings <NUM> can be placed on the closure device <NUM> rather than the sheath body <NUM>.

As shown in <FIG>, a distance d between a distal end of the access sheath <NUM> and a first marking of the plurality of depth markings <NUM> may generally correspond to the distance between the distal end of the puncture dilator and its first marking of the plurality of markings.

Now referring to <FIG>, the guide wire <NUM> can be inserted through the puncture site <NUM> and into the vessel <NUM> such that a portion of the guidewire <NUM> protrudes from the vessel. Once the guidewire <NUM> is positioned, a proximal end of the guidewire <NUM> can be inserted into the distal end of the elongated dilator <NUM>. As shown in <FIG>, the elongated dilator <NUM> can then be moved along the guidewire <NUM> until the distal end of the elongated dilator <NUM> and the blood inlet hole <NUM> enter the vessel <NUM> such that blood flows into the inlet hole <NUM> and into the blood pulsation indicator <NUM>, causing the flexible barrier <NUM> to pulsate, thereby indicating the inlet hole <NUM> is inside the vessel tract. In this scenario the blood within the patient will have a new avenue available to flow within, once the blood begins to flow through the inlet opening <NUM> and out the outlet opening <NUM> it will be caught within a flexible barrier <NUM>. Once the dilator <NUM> has been inserted into the circulatory track the flexible barrier <NUM> will begin to mimic the flow rate and pressure inherent within the vessel. This will cause the flexible barrier <NUM> to pulsate and will supply the practitioner with both a visual and tactile indicator for when the dilator <NUM> is within the vessel. From there a slow removal of the dilator <NUM> is performed, from this action the depth of the puncture can be ascertained, which is when the pulsation of the flexible barrier <NUM> ceases. Once the pulsations have ceased the depth can be collected according to the depth marking visible just above skin level of the patient. In other words, the position of the puncture site <NUM> can be confirmed via feedback of blood flow entering the blood pulsation indicator <NUM> by alternatingly inserting and retracting the elongated dilator <NUM>. As shown in <FIG>, after the position of the puncture site <NUM> has been located, a first visible marking 54a of the dilator <NUM> can be noted. That is a first visible marking 54a that is adjacent the patient's skin can be noted. It should be appreciated, that in some embodiments, the elongated dilator <NUM> can be positioned over the guidewire14 prior to the guidewire being inserted into the vessel <NUM>.

As shown in <FIG>, after the elongated dilator <NUM> has been removed from the guidewire <NUM> and any subsequent dilators have been removed, the access sheath <NUM> can be moved along the guidewire <NUM> toward the puncture site <NUM> such that the distal end of the access sheath <NUM> enters the vessel <NUM> through the puncture site <NUM>. In particular, the proximal end of the guidewire <NUM> is inserted into the distal end of the sheath dilator <NUM>. And then the sheath body <NUM> and sheath dilator <NUM> can be moved together along the guidewire <NUM> toward the puncture site <NUM>. Once inserted, the sheath dilator <NUM> can be pulled proximally such that the sheath dilator <NUM> is removed from the access channel <NUM>.

After the sheath dilator <NUM> has been removed, a vascular closure procedure can be performed through the access channel <NUM>. Therefore, a closure device <NUM> can be moved into the access channel <NUM> until a distal portion <NUM> (e.g. at least a portion of a toggle <NUM>) of the closure device <NUM> is distal to the distal end of the sheath body <NUM>. As shown in Fig. 5C the access sheath <NUM> can then be moved such that a first visible marking 172a of the sheath body <NUM> that is visible adjacent the patient's skin corresponds with the noted first visible marking 54a of the elongated dilator <NUM>. It should be appreciated, that the closure device <NUM> can be moved into the access channel <NUM> either prior to or after the positioning of the access sheath <NUM> such that the first visible marking <NUM> corresponds to the noted depth marking <NUM>. When the access sheath <NUM> is properly positioned, the closure device <NUM> will be positioned such that the sealing procedure can be completed. It should be appreciated, that while in the illustrated embodiment, the depth markings <NUM> are on the sheath body <NUM>, the depth markings can be on the closure device <NUM>, as desired. Furthermore, it should be appreciated, that in such embodiments, the access sheath <NUM> can be pulled completely out of the vessel <NUM> when the closure device <NUM> is properly positioned.

While the foregoing description and drawings represent the preferred embodiment of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the scope of the invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the essential characteristics thereof. One skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components, which are particularly adapted to specific environments and operative requirements without departing from the principles of the invention. In addition, features described herein may be used singularly or in combination with other features. For example, features described in connection with one component may be used and/or interchanged with features described in another component. The presently disclosed embodiment is therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.

Claim 1:
A puncture locating device (<NUM>) for locating a puncture in a blood vessel, the puncture locating device comprising:
an elongated dilator (<NUM>) having a distal end, a proximal end that is opposite the distal end, an outer surface (<NUM>), an internal channel (<NUM>) that extends from the distal end to the proximal end, an inlet opening (<NUM>) that is open to the internal channel (<NUM>) and is spaced from the distal end, and an outlet opening (<NUM>) disposed between the proximal end and the inlet opening (<NUM>);
a flexible barrier (<NUM>) attached to the elongated dilator (<NUM>) and overlying the outlet opening (<NUM>) so that the flexible barrier (<NUM>) and the outer surface (<NUM>) proximate the outlet opening (<NUM>) at least partially define an internal volume; and
wherein the flexible barrier (<NUM>) is configured to be movably responsive to pulsatile blood flow, such that, when the elongated dilator (<NUM>) is inserted into the puncture of the blood vessel, blood flows into the inlet opening (<NUM>) through the outlet opening (<NUM>) into the internal volume, and pulsations in the blood flow cause the flexible barrier (<NUM>) to pulse, thereby generating a visual and tactile indication of presence of the inlet opening (<NUM>) in the blood vessel.