Vascular closure device having an improved plug

Various embodiments of a device are shown and disclosed for closing a vascular access puncture site following percutaneous diagnostic or therapeutic interventional procedures. The vascular closure device includes an improved plug that is configured to be positioned adjacent to the hole in the vasculature. The plug may be shaped to prevent the plug from moving away from the hole in the blood vessel due to pulsatile pressure from the blood. In one embodiment, the plug may include a plurality of projections that extend outward from the plug and contact surrounding tissue in the tissue puncture tract to prevent the plug from moving away from the hole in the blood vessel.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

U.S. patent application Ser. No. 11/842,509, entitled “Extra-Vascular Sealing Device and Method,” filed on 21 Aug. 2007, is hereby incorporated by reference herein in its entirety. In the event of a conflict, the subject matter explicitly recited or shown herein controls over any subject matter incorporated by reference. All definitions of a term (express or implied) contained in any of the subject matter incorporated by reference herein are hereby disclaimed. The paragraphs shortly before the claims dictate the meaning to be given to any term explicitly recited herein subject to the disclaimer in the preceding sentence.

BACKGROUND

Catheter based diagnostic and interventional procedures such as angiograms, balloon angioplasty, stenting, atherectomy, thrombectomy, device placement, etc., are commonly employed to treat patients with vascular obstructions or other abnormalities accessible through the vasculature of the human body. Such interventions are less traumatic to the body than previous surgical interventions and therefore are growing in use.

To gain access to the vasculature, the Seldinger technique is commonly employed. This involves placing a small gauge hollow needle through the skin at about a 30 degree angle to intersect the desired vessel, commonly, but not always, the femoral artery in the groin area. The needle is known to have punctured the vessel wall when blood exits the needle at the proximal end. A guidewire is inserted through the needle into the vessel and the needle is removed. A dilator and introducer sheath are advanced together over the guidewire through the skin and into the vessel. The dilator has a lumen that is sized to receive the guidewire and has a tapered distal end. The introducer sheath has a lumen that is sized to snugly receive the dilator. The size of the introducer sheath is selected (typically 5-8 Fr) to accommodate the catheters anticipated to be used in the procedure. Once the pathway from the outside of the body to the vessel has been established, the dilator and guidewire are removed leaving the introducer sheath in place. A self sealing stretchable valve at the proximal end of the introducer sheath minimizes blood loss during the procedure.

Following the procedure and after all of the catheters and guidewires have been removed from the body, the introducer sheath is removed from the artery. Historically, this has been done by exerting manual pressure on the vessel upstream from the access site to lower blood pressure while the introducer sheath was removed. Once removed, manual pressure is applied directly to the skin above the access puncture for about thirty minutes to inhibit blood loss until the body's natural clotting process sealed the puncture. This technique is generally considered unsatisfactory because it is uncomfortable for the patient and requires a significant amount of nursing staff time.

Sealing the artery by manual compression is rapidly being replaced by medical devices designed to provide a vascular puncture seal in less than five minutes. These devices are intended to be effective and easy to use by medical personnel. The devices range from mechanical suturing devices to collagen plugs, vascular clips, staples, and use of adhesives and sealants. These various approaches have had varying degrees of success and ease of use.

One of the more commonly used devices for closing vessel punctures achieves hemostasis at the vessel puncture site by closing the puncture with an absorbable intra-vessel (e.g., intra-arterial) anchor and an extra-vessel (e.g., extra-arterial) collagen sponge. The anchor and collagen are held together with a self tightening suture loop and slip knot, which, when tightened, sandwiches the puncture hole between the anchor and the collagen sponge. The device is easy to use and the bio-absorbable anchor, collagen and suture sandwich seals the vessel quickly, is more comfortable for the patient, saves valuable nurse time, and allows early patient ambulation.

Although such collagen devices can be highly effective, a substantial number of punctures in, for example, the femoral artery, may cause the patient to be ineligible to use such a device. Factors that may prevent use of this device include presence of peripheral vascular disease, poor needle stick location (too high or too low), or small vessel size which interferes with anchor placement and prevents proper seating of the anchor against the arterial wall.

In an effort to overcome some of these problems, vascular closure devices have been developed that deposit a plug outside the vessel with no component inside the vessel. Such devices may generally require, however, consistently placing the plug near the arterial wall. Unfortunately, these devices suffer from a number of drawbacks. For example, the pressure exerted on the plug can cause the plug to move away from the hole in the vessel resulting in a hemotoma or other complication at the puncture site. Also, the plug may not seal the puncture tract/hole in the blood vessel sufficiently to prevent leakage.

Accordingly, it would be desirable to provide an improved vascular closure device or vascular sealing device that is easy to use, seals quickly and securely, and leaves no component in the blood vessel. A number of embodiments of such improved vascular closure devices are shown and described herein.

SUMMARY

Various embodiments of vascular closure devices are shown and described herein. The vascular closure devices are, generally speaking, hemostatic devices intended to stop bleeding by closing vascular access puncture sites following percutaneous diagnostic or therapeutic procedures. It should be appreciated that the vascular closure devices shown and described herein may be used to close any puncture in any blood vessel although the vascular closure devices are most commonly used to close arteriotomies. It should also be appreciated that the closure devices may be used to close punctures or holes in other bodily vessels.

The vascular closure devices may include an improved plug that is configured to be deployed adjacent to the hole in the blood vessel. The plug may be shaped to prevent the plug from being pushed away from the hole by the pulsatile pressure of the blood in the blood vessel. In one embodiment, the plug may include a plurality of projections that are configured to contact the surrounding tissue in the puncture tract to prevent the plug from moving away from the blood vessel. In another embodiment, the plug may include a plurality of barbs that are configured to contact the surrounding tissue in the puncture tract to prevent the plug from moving away from the blood vessel.

According to one embodiment, a method of closing a hole in a blood vessel comprises locating a wall of the blood vessel adjacent to the hole and positioning a plug outside of the blood vessel and adjacent to the hole, the plug being shaped to prevent the plug from moving away from the blood vessel. The plug may be bioabsorbable and may have an appreciably stable shape in the presence of bodily fluids. According to another embodiment, a method of closing a hole in a blood vessel comprises positioning a plug outside of the blood vessel to close the hole in the blood vessel. According to another embodiment, a method of closing a hole in a blood vessel comprises positioning a plug outside of the blood vessel to close the hole in the blood vessel. The plug may include a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel.

According to another embodiment, a vascular closure device comprises a vessel locating member configured to be inserted through a hole in a blood vessel to locate the position of a wall of the blood vessel that is adjacent to the hole and a plug configured to be deployed outside of the blood vessel adjacent to the hole, the plug being shaped to prevent the plug from moving away from the blood vessel. The plug may be bioabsorbable and may have an appreciably stable shape in the presence of bodily fluids. According to another embodiment, a vascular closure device comprises a vessel locating member configured to locate a wall of a blood vessel that is adjacent to a hole in the blood vessel and a plug configured to be deployed outside of the blood vessel adjacent to the hole in the blood vessel, the plug being shaped to prevent the plug from moving away from the blood vessel, and a sealing material configured to be deployed adjacent to the plug, the sealing material being positioned outside of the blood vessel. The plug may be bioabsorbable.

The foregoing and other features, utilities, and advantages of the subject matter described herein will be apparent from the following more particular description of certain embodiments as illustrated in the accompanying drawings.

DETAILED DESCRIPTION

A number of embodiments of vascular closure devices are shown and described herein. The vascular closure devices may be used to close a hole or puncture in a blood vessel such as an arteriotomy. The vascular closure devices are hemostatic devices that may be used to stop bleeding from vascular puncture sites following percutaneous diagnostic or therapeutic procedures.

The vascular closure devices may be configured to deploy one or more plugs outside of the blood vessel adjacent to the hole. The plug blocks the hole in the blood vessel and/or the puncture tract to stop the bleeding. In one embodiment, the plug is configured to prevent it from moving away from the hole in the blood vessel due to the pulses in the blood pressure. For example, the plug may be shaped to allow the plug to move toward the blood vessel and prevent or impede the plug from moving away from the blood vessel. The plug may include a plurality of projections or barbs that extend outward from the plug to contact the surrounding tissue to prevent the plug from moving away from the blood vessel. In one embodiment, the plug may be bioabsorbable (e.g., the plug may include PGA materials, PLA materials, or combinations thereof). The plug may also be configured to hold its shape in the presence of bodily fluids.

In another embodiment, the plug may be deployed with and/or coupled to a sealing material such as protein-based sealing materials (e.g., collagen, fibrinogen, thrombin, and the like) or lipid based sealing materials (e.g., glycerol monooleate, and the like). The protein based sealing materials may be configured to expand or swell in the presence of blood to assist in sealing the hole in the blood vessel. The lipid based sealing materials may have a melting point that is near and/or slightly below body temperature. The lipid material may be in solid form in the device, then melt to a liquid or semi-liquid (e.g., gel) form when the device is injected into the patient. When the lipid material contacts bodily fluids, it absorbs the body fluids and changes to a cubic phase material which expands in the puncture tract to close the hole in the blood vessel. In one embodiment, the vascular closure devices may be considered extra-vascular closure devices because the devices do not leave any components in the blood vessel.

Before describing the particular embodiments of the vascular closure devices, it should be appreciated that the features, advantages, characteristics, etc. described or shown in connection with one of the embodiments may be applied to or combined with any other embodiment to form an additional embodiment unless noted otherwise. Thus, the various embodiments may be modified in a variety of ways to produce many additional embodiments.

Referring toFIGS. 1-2, one embodiment of a vascular closure device50is shown that may be used to close and/or seal a hole or puncture in a blood vessel such as an arteriotomy. The vascular closure device50includes a carrier tube or carrier member52, a plug or anchor54, a sealing material56, a tamper tube or tamper member58, and a vessel locator tube or vessel locator portion60. The vessel locator tube60extends through the plug54, sealing material56, and the tamper tube58. The tamper tube58is positioned inside the carrier tube52, and the carrier tube52is sized to fit within a closure sheath62. A vessel locating member66and a spring68are positioned at a distal end64of the vascular closure device50.

The vessel locator tube60and the vessel locating member66are generally used to determine the position of the blood vessel as part of the process of closing the hole. The vessel locator tube60includes a core wire or guide wire70that extends from a proximal end to a distal end64of the vascular closure device50. The spring68(e.g., coiled stainless steel spring) is coupled to the distal end of the vessel locator tube60and surrounds the core wire70. The spring68may be coupled to the vessel locator tube60using any suitable fastening mechanism or technique such as, for example, brazing, soldering, or epoxy adhesive. The distal end of the core wire70where it travels through the spring68is tapered or reduced in diameter to make the distal end64of the vascular closure device50more flexible. The distal end of the core wire70is coupled to the distal end of the spring68. Both the core wire70and the spring68are configured to be atraumatic to prevent the distal end64of the vascular closure device50from puncturing or damaging the blood vessel.

The vessel locator tube60also includes a vessel locating member66. The vessel locating member66is positioned at the distal end of the vessel locator tube60. The vascular closure device50is configured so that when it is inserted into the puncture tract the vessel locating member66is positioned inside the blood vessel. In the embodiment shown inFIG. 3, the vessel locating member66includes a plurality of strut members72formed by making a series of cuts65around the vessel locator tube60in a spiral pattern. The cuts may be made using a laser or any other suitable device or technique. In one embodiment, the vessel locating member66may be configured as described in U.S. Patent Application Publication No. 2006/0196137, entitled “Tissue Anchor Apparatus,” filed on 23 Feb. 2006, which is incorporated herein by reference in its entirety.

The vessel locating member66may be configured to move between the contracted configuration shown inFIG. 2and the expanded configuration shown inFIG. 3. This allows the vessel locating member66to be inserted into the blood vessel, expanded, and then moved into contact with the interior wall of the blood vessel adjacent to the hole.

The vessel locating member66moves between the expanded configuration and the contracted configuration as follows. The core wire70is coupled to the vessel locator tube60at a position74that is distal to the vessel locating member66. The vessel locating member66may be expanded by moving the core wire70proximally. Proximal movement of the core wire70exerts a compressive force on the vessel locator tube60that causes the strut members72to deflect outwardly. In one embodiment, the strut members72bow and twist as they deflect outwardly. The result, shown inFIG. 6, is that the strut members72form a plurality of petal shaped vessel locators that extend radially outward from the vessel locator tube60.

The vessel locating member66may be moved back to the contracted configuration shown inFIG. 2by moving the core wire70in a distal direction to its original position. Distal movement of the core wire70exerts a tension force on the vessel locator tube60that causes the strut members72to straighten and contract or collapse so that the strut members72are again in line with the vessel locator tube60.

In one embodiment, the core wire70may be coupled to a handle of the vascular closure device50in a way that allows the core wire70to be moved back and forth as explained. For example, the vascular closure device50may be configured similarly to the vascular closure device referred to in the first paragraph of the specification so that the core wire70moves proximally and distally by moving an actuation member proximally and distally.

As explained above, the cuts65in the wall of the vessel locator tube60may be configured so that the strut members72of the vessel locating member66form a plane that is not perpendicular to the vessel locator tube60as shown inFIG. 3. This may be desirable to create more uniform contact between the vessel locating member66and the interior wall of the blood vessel. Since the puncture tract is usually at a 30-45 degree angle relative to the blood vessel, the plane formed by the vessel locating member66may also be at an approximately 30-45 degree angle relative to the vessel locator tube60. When the vessel locating member66is in the blood vessel, the vessel locating member66may be roughly parallel to the interior wall of the blood vessel just before the vessel locating member66contacts the interior wall.

It should be appreciated that the configuration of the vessel locating member66can be modified in any of a number of ways. For example, the vessel locating member66may be configured to be perpendicular to the vessel locator tube60. In another embodiment, the vessel locating member66may include an inflatable balloon (e.g., inflated with a fluid such as saline solution, carbon dioxide, etc., dispensed from a syringe or other device or container).

It should be appreciated that the vessel locator tube60and any of the other components of the vessel locator tube60may be made of any suitable material such as metal, plastics, or composites. Since the vascular closure device50is a medical device, the materials used may also be medical grade (medical grade metals, plastics, or composites). In one embodiment, the vessel locator tube60and the core wire70may be made of metals such as stainless steel or memory shape metals such as nitinol, and the like. In another embodiment, the vessel locator tube60may be made of a memory shape material such as nitinol (e.g., nitinol hypotube) to allow the vessel locating member66to repeatedly expand and contract. In yet another embodiment, the core wire70may be a stainless steel wire.

The plug54may be positioned at a predetermined distance in the proximal direction from the vessel locating member66. The distance between the plug54and the vessel locating member66is selected so that when the vessel locating member66is positioned against the interior wall of the blood vessel, a set of projections76(described in further detail below) of the plug54is positioned just outside of the hole in the blood vessel and a distal end of the plug54is positioned within the hole in the blood vessel (seeFIGS. 5 and 6). The distal end of the plug54may be shaped to be at least substantially flush with the interior wall of the blood vessel as shown in the FIGS. Typically, the distal end of the plug54is angled to the same degree as the introducer sheath62.

The plug54is slidably received by the vessel locator tube60. A marker band61is coupled to the vessel locator tube60to prevent proximal movement of the plug54as it is inserted into the puncture tract. This marker band61also prevents proximal movement of the plug54during suture take up and removal of the device and assures fixed distance between the locating member66and the plug54. As shown inFIG. 2, the marker band61is received inside the plug54until it reaches an area where the internal diameter of the plug54is smaller than the marker band61. At this point, the marker band61prevents the plug54from moving further in the proximal direction. The marker band may be fixed to the vessel locator tube60in any of a number of suitable ways such as brazing or with adhesives.

The plug54shown inFIG. 1includes a plurality of projections or barbs76that extend outward and are tapered backwards from the distal end of the plug54to prevent the plug54from moving away from the blood vessel when the plug54is deployed adjacent to the hole in the blood vessel. The tapered shape of the projections76allow the plug54to move distally through the tissue tract but prevent the plug54from moving proximally in the tissue tract.

The projections76may be made of a resilient material (e.g., elastomeric material) that allows the projections to be compressed inward when the plug54moves through the puncture tract in a distal direction. However, when a tensile force is applied to the plug54in the proximal direction, the projections76may expand and engage the surrounding tissue to prevent proximal movement of the plug54. The projections76prevent the plug54from being pushed away from the hole in the blood vessel by the pressure pulses of the blood, thus preventing a hematoma or surface bleeding.

It should be appreciated that the projections76may take any suitable form to prevent the plug54from moving away from the hole in the blood vessel. For example, another embodiment of a plug78is shown inFIGS. 9-11that includes a plurality of projections or barbs80that have a sloped pyramid shape. The projections80slope outward and backwards in a proximal direction so that the proximal side of the projections80is a flat surface82that extends outward almost perpendicular to the plug78. The flat surface82is configured to engage the tissue in the tissue tract to prevent the plug78from moving away from the hole in the blood vessel.

Another embodiment of a plug84is shown inFIGS. 12-13. In this embodiment, the plug84includes a sleeve86and a core or main body88that fits inside the sleeve86. The core88includes a plurality of resilient or flexible projections or barbs90. The sleeve86includes a plurality of corresponding holes92. The core88is configured to slide between a first configuration where the projections90are pressed snugly between the wall of the sleeve86and the core88and a second configuration where the projections90are configured to extend outward through the holes92in the sleeve86. The plug84may be moved between the first configuration and the second configuration by selectively moving the core88further distally into or proximally out of the sleeve86or the core can be twisted (i.e., rotated about its axis) relative to the sleeve86.

FIG. 14shows yet another embodiment of a plug94that is shaped to prevent the plug94from moving away from the hole in the blood vessel. In this embodiment, the vessel locator tube60extends through a centrally located slot or hole96in the plug94. The slot96is shaped to allow the plug94to pivot so that the plug94is at an angle relative to the vessel locator tube60. This allows the plug94to fit inside the closure sheath62. The plug94is deployed by advancing the plug94through the closure sheath62to the site of the puncture in the blood vessel. Once the closure sheath62is retracted and the plug94exposed, the plug94is pushed distally which causes the plug94to pivot to be perpendicular to the vessel locator tube60and the puncture tract to close the hole in the blood vessel.

FIG. 15shows yet another embodiment of a plug98that is shaped to prevent the plug98from moving away from the hole in the blood vessel. The plug98includes a plurality of projections or barbs100that extend outward from the plug98. In this embodiment, the plug98is configured to mesh with the distal end of tube102so that the projections cannot catch the surrounding tissue of the puncture tact. The plug98may be deployed using the carrier tube52. In this embodiment, the carrier tube52is tapered at the distal end so that it will catch the projections100and move the plug98distally from the tube102to expose the projections100to the surrounding tissue of the puncture tract. In the natural configuration of the plug98the bargs100project radially outward from the main body portion of the plug98. Until the plug is to be deployed, the carrier tube52holds the barbs in a retracted state against the main body portion of the plug98. Once in place, the vessel locator tube60may be withdrawn through the hole in the plug98.

It should be appreciated that the embodiments of the plugs shown herein may be made of any suitable material. In one embodiment, the plugs are made of bioabsorbable materials such as PGA (poly glycolic acid), PLA (poly lactic acid), PCL (polycaprolactone), copolymers thereof, or variants or derivatives thereof. In another embodiment, the plugs may have an appreciably stable shape in the presence of bodily fluids so that the projections on and/or shape of the plugs are sufficient to contact the surrounding tissue in the puncture tract and hold the plugs in place.

Turning back toFIGS. 2-3, the tamper tube58may be used to tamp or compress a sealing material56against the plug54. As shown, the sealing material56has a pre-formed shape and may be concentrically disposed around locator tube60(in cross section), as shown inFIG. 2. Alternatively, sealing material56may be positioned on one side of locator tube60so that the sealing material56forms a generally c-shaped configuration (in cross section), as shown inFIG. 3, with the material forming an apex57about an axis that is parallel to the central axis of locator tube60.

Tamper tube58compresses the sealing material56relative to the plug54. The tamping action serves to push the sealing material56radially outward into the tissue of the puncture tract. This helps to hold the sealing material56and the plug54in place as well as to further seal the puncture tract to prevent blood from leaking out.

A suture or filament104may be used to hold the plug54and the sealing material56together. A slip knot114(FIG. 8) may be used to hold the sealing material56in a compressed state. At leastFIG. 8shows the sealing material56anchored in the puncture tract at least in part by connection of the sealing material56to the plug54with the suture104. Referring back toFIG. 2, the vascular closure device50is configured to deploy the sealing material56adjacent to the hole in the blood vessel. In one embodiment, the sealing material56may be configured to swell when it contacts blood to further assist in closing the hole. The sealing material56may be any suitable material such as collagen or glycerol monooleate. Also, the sealing material56may be tapered at the distal end so that the sealing material fits into the hole in the blood vessel better. The distal end of the sealing material may have any suitable angle. It should be appreciated that the suture104may be unnecessary in those embodiments where glycerol monooleate or similar materials are used.

For those embodiments that use the suture104, the plug54may include a transverse hole or lumen106sized to receive the suture104. The suture104extends through the plug54and the sealing material56. In the embodiment shown inFIGS. 2-3, the suture104passes through multiple holes in the sealing material56in a distal direction, through the transverse hole106in the plug54, and back through more holes in the sealing material56in a proximal direction. As mentioned, a slip knot114(FIG. 8) may be provided on one end of the suture104above the sealing material56so that a loop is formed around the plug54and the sealing material56. The other end of the suture104may extend proximally from the sealing material56through the tamper tube58to the proximate end of the vascular closure device50. The suture104may be tightened by pulling on the suture at the proximate end of the vascular closure device50which tightens a slipknot of the suture in a known manner.

A method of closing a hole110in a blood vessel108using the vascular closure device50is described in connection withFIGS. 4-8. Initially, the procedural sheath is exchanged for the closure sheath62. This exchange of the procedural sheath for the closure sheath62may not be required depending upon the sizing of the vascular closure device50. This is done by placing a guidewire through the procedural sheath and into the blood vessel108. The procedural sheath is then withdrawn from the body while holding digital pressure on the blood vessel108, upstream from the sheath, and while holding the guidewire in place. Next, a closure dilator is placed within the closure sheath62and the distal tapered end of the closure dilator is back-loaded onto the guidewire. The closure dilator and the closure sheath62are advanced together distally over the guidewire, through the puncture or tissue tract112, and into the blood vessel108.

In one embodiment, the closure sheath62includes a distal side hole (not shown) near the distal end of the closure sheath62. The closure dilator also includes a distal side hole that is configured to align with the distal side hole in the closure sheath62when the closure dilator is positioned in the closure sheath62. The closure dilator also has a proximal side hole at the proximal end of the closure dilator that is in fluid communication with the distal side hole of the closure dilator and the closure sheath. In one embodiment, the distal and proximal side holes may be fluidly connected by way of a dedicated lumen or bore. In another embodiment, the distal and proximal side holes may be fluidly connected by the central lumen of the closure dilator that the guidewire is positioned in.

The side holes in the closure sheath62and the closure dilator are provided to allow blood to flash back when the closure sheath62is correctly positioned in the blood vessel108. Once blood flows out the proximal side hole of the closure dilator, the user pulls the closure sheath62in a proximal direction until the blood flow just stops. The closure sheath62is now placed in the correct position to continue the procedure. The next step is to withdraw the closure dilator and the guidewire while holding the closure sheath62in place.

The closure sheath62is sized to slidably receive the vascular closure device50therein. The distal end of the closure sheath62is tapered so that the tip will align with the lengthwise axis of the blood vessel108when the closure sheath62is inserted through the puncture tract112at an angle of about 30-45 degrees to the vessel axis.

After the closure sheath62is in place, the vascular closure device50is introduced into the proximal end of the closure sheath62. The vascular closure device50may be configured to advance until it snaps, locks, or otherwise mates together with the carrier tube62. In this position, the distal end64of the vascular closure device50extends out of the distal end of the closure sheath62and into the blood vessel108. It should be noted that the vascular closure device50and the closure sheath62may be configured so that when they are coupled together, the distal end64extends into the blood vessel108a predetermined amount.

FIG. 4shows the vessel locating member66in position in the blood vessel108. The vessel locating member66is expanded by pulling the core wire70proximally as explained above.FIG. 5shows the vessel locating member66in the expanded configuration. The closure sheath62and the vascular closure device50are drawn away from the patient until the vessel locating member66contacts the vessel wall at the puncture site.

Now that the vessel locating member66and the plug54are in position, the closure sheath62and the carrier tube52are withdrawn to expose the plug54and the sealing material56to the tissue puncture tract112. The sealing material, which may include a collagen sponge, is now exposed to the puncture tract and starts to absorb blood and swell. It should be appreciated that the vascular closure device50may be configured to not use the sealing material56and only use the plug54. The plug54may adequately close the hole110by itself.

Now that the sealing material56has been deployed, the next step is to tamp it with the tamper tube58. This is accomplished by pushing the tamper tube58distally into the sealing material56as shown inFIG. 6. The tamper tube58compresses the sealing material56against the plug54, the wall of the blood vessel108, and the vessel locating member66. The vessel locating member66prevents the sealing material56and/or the plug54from being pushed inside the blood vessel108during the tamping procedure.FIG. 7shows the sealing material56after the tamper tube58has been retracted.

The suture104is tightened to hold the sealing material56in a compressed state. The suture is tightened by pulling it in a proximal direction to tighten the slip knot. At this point, the sealing material56and the plug54have been deployed and the only remaining steps are to remove the closure sheath62and the vascular closure device50.

It should be appreciated that certain sealing materials56such as glycerol monooleate and the like may not require tamping and/or the use of the suture104. Since these materials melt or form a gel at bodily temperatures, they initially flow against the proximal end of the plug54. As these materials interact with body fluids they take on a different form that causes them to swell and further seal the puncture tract112.

The first step in removing the vascular closure device50is to contract or collapse the vessel locating member66and remove the vessel locator tube60from the vascular closure device50. The vessel locating member66is contracted by moving the core wire70distally as explained above. At this point, the vessel locator tube60may be pulled out of the proximal end of the vascular closure device50. As the vessel locator tube60passes through the sealing material56, the sealing material56swells to fill the gap where the vessel locator tube60used to be. The hole in the blood vessel108is now sealed by clotting action and the swelling of the sealing material56against the walls of puncture tract112. The plug54and the sealing material56are not disturbed by the removal of the vessel locator tube60since the vessel locator tube60and the coiled spring68are smaller than the lumens through the plug54and the sealing material56.

The remainder of the vascular closure device50can be removed by pulling it proximally out of the puncture tract112. The suture104may be cut at any time. If the suture104still extends out of the skin, the user can cut again by compressing the skin and severing the suture104at a point below the surface of the skin. The closure procedure is now complete and the sealing material56, suture104, and the plug54will be absorbed by the body in about 90 days or less.

It should be appreciated that the embodiments disclosed have many components and the methods described have many steps for operation and use. It is anticipated that the number of components and steps could be altered considerably (e.g., remove the second tube74, etc.) without departing from the broad scope of what is described herein. For example the steps of tamping and tensioning the suture104could be combined into one step.

Illustrative Embodiments

Reference is made in the following to a number of illustrative embodiments of the subject matter described herein. The following embodiments illustrate only a few selected embodiments that may include the various features, characteristics, and advantages of the subject matter as presently described. Accordingly, the following embodiments should not be considered as being comprehensive of all of the possible embodiments. Also, features and characteristics of one embodiment may and should be interpreted to equally apply to other embodiments or be used in combination with any number of other features from the various embodiments to provide further additional embodiments, which may describe subject matter having a scope that varies (e.g., broader, etc.) from the particular embodiments explained below. Accordingly, any combination of any of the subject matter described herein is contemplated.

According to one embodiment, a method of closing a hole in a blood vessel comprises: locating a wall of the blood vessel adjacent to the hole; and positioning a plug outside of the blood vessel and adjacent to the hole, the plug being shaped to prevent the plug from moving away from the blood vessel; wherein the plug is bioabsorbable and has an appreciably stable shape in the presence of bodily fluids. The plug may include a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a plurality of barbs that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a rod that moves inside a sleeve, wherein the rod may include a plurality of projections that extend through a corresponding plurality of holes in the sleeve to contact surrounding tissue to prevent the plug from moving away from the blood vessel. Locating the wall of the blood vessel may include inserting a vessel locating member through the hole in the blood vessel, expanding the vessel locating member, and moving the vessel locating member into contact with the wall of the blood vessel. The vessel locating member may include a tube having a wall with a plurality of cuts in it, the wall of the tube being configured to expand where the plurality of cuts are located when the tube is compressed. The vessel locating member may include a balloon. The method may comprise deploying a sealing material adjacent to the plug.

According to another embodiment, a method of closing a hole in a blood vessel comprises: positioning a plug outside of the blood vessel to close the hole in the blood vessel; wherein the plug is bioabsorbable and has an appreciably stable shape in the presence of bodily fluids. The plug may be shaped to prevent the plug from moving away from the blood vessel. The plug may include a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a plurality of barbs that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a rod that moves inside a sleeve, wherein the rod may include a plurality of projections that extend through a corresponding plurality of holes in the sleeve to contact surrounding tissue and thereby prevent the plug from moving away from the blood vessel. The method may comprise deploying a sealing material adjacent to the plug. The method may comprise compressing the sealing material and the plug together. The method may comprise holding the sealing material and the plug together using a suture.

According to another embodiment a method of closing a hole in a blood vessel comprises: positioning a plug outside of the blood vessel to close the hole in the blood vessel; wherein the plug includes a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a plurality of barbs that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a rod that moves inside a sleeve, wherein the rod may include a plurality of projections that extend through a corresponding plurality of holes in the sleeve to contact surrounding tissue and thereby prevent the plug from moving away from the blood vessel. The method may comprise deploying a sealing material adjacent to the plug. The method may comprise locating a wall of the blood vessel adjacent to the hole.

According to another embodiment, a vascular closure device comprises: a vessel locating member configured to be inserted through a hole in a blood vessel to locate the position of a wall of the blood vessel that is adjacent to the hole; and a plug configured to be deployed outside of the blood vessel adjacent to the hole, the plug being shaped to prevent the plug from moving away from the blood vessel; wherein the plug is bioabsorbable and has an appreciably stable shape in the presence of bodily fluids. The plug may include a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a plurality of barbs that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a rod that moves inside a sleeve, wherein the rod may include a plurality of projections that extend through a corresponding plurality of holes in the sleeve to contact surrounding tissue and thereby prevent the plug from moving away from the blood vessel. The vessel locating member may be configured to move between an expanded configuration and a contracted configuration. The vessel locating member may include a tube having a wall with a plurality of cuts in it, the wall of the tube being configured to expand where the plurality of cuts are located when the tube is compressed. The vessel locating member may include a balloon.

According to another embodiment, a vascular closure device comprises: a vessel locating member configured to locate a wall of a blood vessel that is adjacent to a hole in the blood vessel; a plug configured to be deployed outside of the blood vessel adjacent to the hole in the blood vessel, the plug being shaped to prevent the plug from moving away from the blood vessel; and a sealing material configured to be deployed adjacent to the plug, the sealing material being positioned outside of the blood vessel; wherein the plug is bioabsorbable. The plug may include a plurality of projections that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a plurality of barbs that are configured to contact surrounding tissue to prevent the plug from moving away from the blood vessel. The plug may include a rod that moves inside a sleeve, wherein the rod may include a plurality of projections that extend through a corresponding plurality of holes in the sleeve to contact surrounding tissue and thereby prevent the plug from moving away from the blood vessel. The vascular closure device may be configured so that the plug and the vessel locating member are positioned near each other so that when the vessel locating member is in contact with an interior surface of the wall of the blood vessel, the plug is adjacent to the wall on the outside of the blood vessel. The vessel locating member may be configured to move between an expanded configuration to allow the vessel locating member to contact the interior surface of the wall of the blood vessel and a contracted configuration to allow the vessel locating member to pass through the hole in the blood vessel. The sealing material may include collagen. The vascular closure device may comprise a suture configured to hold the sealing material and the plug together. The vascular closure device may comprise a tamper member configured to move the sealing material toward the plug.

The terms recited in the claims should be given their ordinary and customary meaning as determined by reference to relevant entries (e.g., definition of “plane” as a carpenter's tool would not be relevant to the use of the term “plane” when used to refer to an airplane, etc.) in dictionaries (e.g., widely used general reference dictionaries and/or relevant technical dictionaries), commonly understood meanings by those in the art, etc., with the understanding that the broadest meaning imparted by any one or combination of these sources should be given to the claim terms (e.g., two or more relevant dictionary entries should be combined to provide the broadest meaning of the combination of entries, etc.) subject only to the following exceptions: (a) if a term is used herein in a manner more expansive than its ordinary and customary meaning, the term should be given its ordinary and customary meaning plus the additional expansive meaning, or (b) if a term has been explicitly defined to have a different meaning by reciting the term followed by the phrase “as used herein shall mean” or similar language (e.g., “herein this term means,” “as defined herein,” “for the purposes of this disclosure [the term] shall mean,” etc.). References to specific examples, use of “i.e.,” use of the word “invention,” etc., are not meant to invoke exception (b) or otherwise restrict the scope of the recited claim terms. Other than situations where exception (b) applies, nothing contained herein should be considered a disclaimer or disavowal of claim scope. The subject matter recited in the claims is not coextensive with and should not be interpreted to be coextensive with any particular embodiment, feature, or combination of features shown herein. This is true even if only a single embodiment of the particular feature or combination of features is illustrated and described herein. Thus, the appended claims should be read to be given their broadest interpretation in view of the prior art and the ordinary meaning of the claim terms.

As used herein, spatial or directional terms, such as “left,” “right,” “front,” “back,” and the like, relate to the subject matter as it is shown in the drawing FIGS. However, it is to be understood that the subject matter described herein may assume various alternative orientations and, accordingly, such terms are not to be considered as limiting. Furthermore, as used herein (i.e., in the claims and the specification), articles such as “the,” “a,” and “an” can connote the singular or plural. Also, as used herein, the word “or” when used without a preceding “either” (or other similar language indicating that “or” is unequivocally meant to be exclusive—e.g., only one of x or y, etc.) shall be interpreted to be inclusive (e.g., “x or y” means one or both x or y). Likewise, as used herein, the term “and/or” shall also be interpreted to be inclusive (e.g., “x and/or y” means one or both x or y). In situations where “and/or” or “or” are used as a conjunction for a group of three or more items, the group should be interpreted to include one item alone, all of the items together, or any combination or number of the items. Moreover, terms used in the specification and claims such as have, having, include, and including should be construed to be synonymous with the terms comprise and comprising.

Unless otherwise indicated, all numbers or expressions, such as those expressing dimensions, physical characteristics, etc. used in the specification (other than the claims) are understood as modified in all instances by the term “approximately.” At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the claims, each numerical parameter recited in the specification or claims which is modified by the term “approximately” should at least be construed in light of the number of recited significant digits and by applying ordinary rounding techniques. Moreover, all ranges disclosed herein are to be understood to encompass and provide support for claims that recite any and all subranges or any and all individual values subsumed therein. For example, a stated range of 1 to 10 should be considered to include and provide support for claims that recite any and all subranges or individual values that are between and/or inclusive of the minimum value of 1 and the maximum value of 10; that is, all subranges beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less (e.g., 5.5 to 10, 2.34 to 3.56, and so forth) or any values from 1 to 10 (e.g., 3, 5.8, 9.9974, and so forth).