US 20100179589 A1
An anchor for using a closure device includes a body being configured to move from a pre-deployed state to a deployed state. In the pre-deployed state, the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.
1. An anchor for using a closure device, the anchor comprising:
a body being configured to move from a pre-deployed state to a deployed state, wherein in the pre-deployed state the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.
2. The anchor of
3. The anchor of
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11. The anchor of
12. The anchor of
13. The anchor of
14. The anchor of
15. The anchor of
16. The closure device of
17. A method of closing a puncture in a wall of a body lumen, comprising:
advancing an anchor in a deployment direction through the anchor, the anchor having a first width aspect relative to the deployment direction;
deploying the anchor distally of the wall of the body lumen to cause the anchor to move to have a second width aspect relative to the deployment direction, the second width aspect being larger than the first width aspect;
drawing the anchor distally into engagement with a distal side of the wall of the body lumen; and
deploying a closure element into the wall of the body lumen, wherein the anchor is formed from a rapidly eroding material that dissolves in the body lumen in less than twelve hours.
18. The method of
19. The method of
20. The method of
21. A closure device system comprising:
a delivery sheath;
a rapidly eroding anchor at least partially disposed within the delivery sheath in an initial configuration, the closure member comprising one or more sugars;
a suture element coupled to the closure member and disposed at least partially through the delivery sheath; and
a pusher disposed at least partially within the delivery sheath and configured to deploy the anchor member from a distal end of the delivery sheath.
22. The closure device system of
23. The closure device system of
This patent application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/143,751, entitled “Vessel Closure Devices and Methods,” filed Jan. 9, 2009, the disclosure of which is incorporated herein by reference in its entirety.
1. Technical Field
The present disclosure relates generally to medical devices and their methods of use. In particular, the present disclosure relates to vessel closure systems and devices and corresponding methods of use.
2. The Technology
Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guidewire may be advanced through the needle and into the patient's blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guidewire into the vessel, e g in conjunction with or subsequent to a dilator.
A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
Upon completing the procedure, the devices and introducer sheath would be removed, leaving a puncture site in the vessel wall. Traditionally, external pressure would be applied to the puncture site until clotting and wound sealing occur. However, the patient must remain bedridden for a substantial period after clotting to ensure closure of the wound. This procedure may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
An anchor for using a closure device may include a body being configured to move from a pre-deployed state to a deployed state. In the pre-deployed state, the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.
A method of closing a puncture in a wall of a body lumen may include advancing an anchor in a deployment direction through the anchor, the anchor having a first width aspect relative to the deployment direction, deploying the anchor distally of the wall of the body lumen to cause the anchor to move to have a second width aspect relative to the deployment direction, the second width aspect being larger than the first width aspect, drawing the anchor distally into engagement with a distal side of the wall of the body lumen, and deploying a closure element into the wall of the body lumen, wherein the anchor is formed from a rapidly eroding material that dissolves in the body lumen in less than twelve hours.
A closure device system may include a delivery sheath, a rapidly eroding anchor at least partially disposed within the delivery sheath in an initial configuration, the closure member comprising one or more sugars, a suture element coupled to the closure member and disposed at least partially through the delivery sheath, and a pusher disposed at least partially within the delivery sheath and configured to deploy the anchor member from a distal end of the delivery sheath.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
To further clarify the above and other advantages and features of the present disclosure, a more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the disclosure and are therefore not to be considered limiting of its scope. The disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
The present disclosure relates to devices, systems, and methods for closing an opening in a body lumen. For example, the present disclosure includes an anchor, such as an intra-arterial “foot,” comprising a rapidly eroding material. The anchor may be passed through an opening defined in a wall of a body lumen and deployed. The anchor can then be drawn proximally to draw the anchor into contact with a distal side of the body lumen wall. A closure element can then be deployed to close the puncture.
In at least one example, once deployed within a body lumen, the anchor may dissolve in less than a day or even less than an hour as desired. The rapid erosion of the anchor can allow the anchor to be left in place after the closure element has been deployed by obviating the need for removal of the anchor. By leaving the anchor in place until it dissolves, damage that may occur by drawing the anchor through the closed puncture and/or the deployed closure element can be reduced or eliminated.
In addition, the erosion time of the anchor may fall within the time frame of the action of an anti-thrombotic medication being used in conjunction with the treatment of a patient. Accordingly, the closure element of the present disclosure may reduce the risk of formation of intra-arterial clots associated with the closure of the body lumen opening.
Reference is now made to
More specifically, the second portion 116B of the interior lumen 116 may have a larger width aspect than the width aspect of the first portion 116A. The width aspects of the first portion 116A and the second portion 116B can be the diameters thereof or other cross sectional profiles that are generally transverse to a center axis C of the delivery sheath 110. For ease of reference, the center axis C of the delivery sheath 110 will be referenced in describing the position and movement of the other components described herein. In the illustrated example, the interior lumen 116 may transition from the smaller diameter of the first portion 116A to a second larger diameter of the second portion 116B at a shoulder 118.
Such a configuration can allow the pusher 120 to translate axially relative to the delivery sheath 110 within a desired range of motion. In particular, the handle portion 122 can translate within the second portion 116B of the interior lumen 116 to advance the shaft portion 124 within the outer housing 112 to thereby move the distal end 124A of the shaft portion 124 relative to the distal end 112A of the outer housing 112. Interaction between the handle portion 122 and the shoulder 118 can help ensure the distal end 124A does not extend beyond a desired position within the outer housing 112.
In the illustrated example, the first portion 116A may also be configured to receive the anchor 130 and the closure element 140 proximally of the distal end 124A of the shaft portion 124. Accordingly, as the distal end 124A of the shaft portion 124 is advanced toward the distal end 112A of the outer housing 112, the distal end 124A of the shaft portion 124 can engage the anchor 130 and/or the closure element 140 to move the anchor 130 and/or the closure element 140 distally from the outer housing 112.
The anchor 130 can be configured to move from a pre-deployed state having a pre-deployed width aspect to a deployed state having a deployed width aspect. The deployed width aspect may be greater than the pre-deployed width aspect. The anchor 130 can have any configuration that allows for this. In the illustrated example, anchor 130 is configured to rotate or be rotated between the pre-deployed state and the deployed state. In other examples, the anchor 130 may be configured to unfold from a configuration have a pre-deployed width aspect to a deployed state having a greater width aspect. For example, one or more arms may be configured to unfold and fold about a plurality of pivot or hinge points.
As shown in
This rotation can be accomplished by applying a distally acting force on the anchor 130 to move the anchor 130 out of the outer housing 112 and then a proximally directed force to the anchor 130 by way of the eyelet 138. In at least one example, the distally acting force applied to the anchor 130 can be provided from the pusher 120 by way of the closure element 140 while the proximally directed force can be applied by way of the suture element 150. The anchor 130 can thus be used to position the closure device 100 for deployment of the closure element 140.
In one embodiment, the closure element 140 may be configured to close an opening in a lumen as well as at least partially obstruct a tissue tract leading from an external surface of the tissue to the lumen. The shape of the closure element 140 may be configured to be housed within the first portion 116A of the interior lumen 116. For example, the closure element 140 may conform to the shape of the interior lumen 116. In one embodiment, the closure element 140 may be cylindrical in shape prior to being deployed from the delivery sheath 110. Once deployed from the delivery sheath 110, the closure element 140 may be deformable to conform to any desired shape to close an opening in a body lumen and/or the tissue tract leading to the lumen opening.
As shown, the example pusher 120 can be coupled to the closure element 140 and/or anchor 130 by way of the suture element 150. In particular, the suture element 150 can loop through the anchor 130 such that the suture element 150 has two free ends that pass through or near the closure element 140, and extend proximally into or beyond the handle portion 122 of the pusher 120. In at least one example, the free ends of the suture element 150 pass through separate portions or channels of the closure element 140. In one embodiment, the pusher 120 can have a suture lumen 126 defined therein that extends through the shaft portion 124 and extends proximally to or even through the handle portion 122. The suture element 150 can be extended from the closure element 140 and into the pusher 120 by way of the suture lumen 126.
In one embodiment, the delivery sheath 110 may include a guidewire lumen 160 with a proximal guidewire port 162 therein near the proximal end 112B of the outer housing 112 and a distal guidewire port 164 near the distal end 112A of the outer housing 112. The guidewire lumen 160 may be at least partially integrated or entirely distinct from the interior lumen 116 of the delivery sheath 110. Accordingly, a guidewire can enter the proximal guidewire port 162, pass through the guidewire lumen 160, and exit the distal guidewire port 164. As a result, the example closure device 100 can advance over a guidewire and into position with a lumen opening as part of a method to close the lumen opening. One such method will now be discussed in more detail with reference to
Reference is now made to
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In particular, as shown in
As also shown in
With the anchor 130 deployed, the pusher 120 may then deploy the closure element 140 within the puncture 176 and/or the tract 170 near a proximal side 178B of the lumen wall 178. In particular, as shown in
In such a step, the lumen wall 178 is positioned between the anchor 130 and the closure element 140. Thus, the closure element 140 can be positioned to reduce or stop the flow of fluid out of the tract 170 by covering the puncture 176 and/or obstructing the tract 170.
In one embodiment, the pusher 120 remains in continuous contact with the closure element 140 throughout the deployment process. Such a configuration can allow the anchor 130 and/or closure element 140 to be deployed by advancing the pusher 120 in a single direction. By facilitating deployment of the anchor 130 and closure element 140 using one-way movement of the pusher 120, and by utilizing a single pusher 120, the closure device 100 may result in a quicker and easier deployment of the anchor 130 and/or closure element 140.
The engagement of the anchor 130 and the closure element 140 to the lumen wall 178 may be secured in any desired manner. In at least one example, the free ends of the suture element 150 may pass from the anchor 130 through the closure element 140. In such an example, a suture lock and/or a knot pusher can be used to advance a knot into proximity with the closure element 140 and tighten the knot to thereby maintain tension between the anchor 130 and the closure element 140. A suture cutter can then sever the suture element 150. A suture lock, a knot pusher, and/or a suture cutter can be advanced through a suture lumen 126 defined in the pusher 120 either before or after the delivery sheath 110 and the pusher 120 are withdrawn from the tract 170. As a result, the suture element anchor 130, closure element 140, and suture element 150 can remain in the tissue tract 170 as shown in
As previously introduced, the anchor 130 can be formed of a rapidly eroding material that allows the anchor 130 to be left in place within the lumen 174. The composition of the anchor 130 allows the anchor 130 to remain in position for a long enough period to enable the closure procedure and a short enough period to allow sufficient erosion of the anchor 130 while the patient is still under physician control or in the hospital. This time period can therefore be in a range of roughly between 30 minutes and 12 hours. The anchor 130 may be formed of a material that is strong enough to allow for secure anchoring of a closure element, such as the plug and/or other closure elements described below.
Further, the anchor 130 may be formed of a material that is biocompatible in an intravascular environment and non-thrombogenic. An anchor with these characteristics may be obtained by using a mechanism of dissolution rather than chemical degradation. Rapidly dissolving compounds that are suitable include, but are not limited to, sugars and sugar-derivatives like sugar-alcohols. Representative examples are sugars like glucose, fructose, lactose, maltose, and sugar alcohols like mannitol, sorbitol and isomalt. Strength can be added to the formulation by including a polymeric component, such as poly-vinylpyrrolidone, poly-ethyleneglycol, or a polysaccharide like starch, hydroxyethylstarch, dextran or dextran sulfate. Sugar alcohols such as mannitol, sorbitol, and isomalt have relatively low melting points, and form good solvents for the polysaccharides. This can facilitate manufacturing, since a simple melt process can be used. Various mixtures of these components are possible, resulting in potentially different anchor properties. Hydroxyethyl starch has a relatively low glass transition temperature, and so has a mannitol-sorbitol mixture. A solution of hydroxyethyl starch in mannitol-sorbitol, when solidified, may have a glass transition below body temperature, which will create a tough, but not brittle anchor. On the other end of the spectrum, a mixture of dextran with isomalt has a much higher glass transition, resulting in a very hard and strong anchor, but with higher brittleness. Since all these components are miscible, a wide range of properties can be achieved by mixing them in corresponding proportions to achieve the desired properties.
In one embodiment, the rapidly eroding material can be configured to be at least partially porous and/or micro-porous. Accordingly, one or more beneficial agents can be incorporated into at least one of the pores of the rapidly eroding material. For example, the beneficial agents may include anti-clotting agents, such as heparin, anti-inflammatory agents, and/or other beneficial agents. One method for producing a porous rapidly eroding material may include freeze drying the rapidly eroding material. In particular, in one example embodiment, acetic acid may be used as a solvent for freeze drying the rapidly eroding material. Polymers, such as PLGA, which are soluble in acetic acid, may be used as part of the freeze-drying process.
In a further embodiment, a micro-porous silicon may be used. In particular, the micro-porous silicon may be prepared with various degradation rates, including rapidly degrading forms. The micro-porous silicon may be sufficiently strong to be used in an anchor, such as a bioerodible foot, and/or may also have sufficient porosity to allow incorporation of beneficial agents. For example, in one embodiment, it may be desirable to incorporate a hydrophobic heparin derivative, such as benzalkonium heparin, into the porosity of the anchor because of its low solubility. The closure element 140 may comprise any number of different materials suitable for use as a plug.
The pusher 120′ can be configured to translate axially within the carrier tube 240 to deploy the anchor 130′ from the closure device 200. A closure element 250 is configured to be positioned on the carrier tube 240. As will be discussed in more detail below, distal movement of the actuator member 230 relative to the carrier tube 240 may deploy the closure element 250.
In the illustrated example, the garage sheath 220 includes a housing portion 222 coupled to a plunger portion 224. The first plunger portion 224 can be positioned proximally of the grip portion 114′ of the delivery sheath 110. The actuator member 230 can include a housing portion 232 and a second plunger portion 234. The carrier tube 240 can also include a housing portion 242 and a third plunger portion 244. The pusher 120′ includes a handle portion 122′ and a shaft portion 124′.
As shown in
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As shown in
Continued advancement of the actuator member 230 distally relative to the carrier tube 240 moves tissue-engaging portions 252 of the closure element 250 into engagement with the lumen wall 178. Further distal movement of the actuator member 230 pushes the closure element 250 distally of the carrier tube 240. In at least one example, the closure element 250 can be formed of a resilient material having a trained or default state having a narrow diameter. The closure element 250 can be partially expanded onto the carrier tube 240 prior deployment. As the closure element 250 moves distally from the carrier tube 240, the closure element 250 can move toward the trained or default state, thereby closing the puncture 176.
As shown in
Embodiments of the closure element, the delivery sheath, and the like may include a material made from any of a variety of known suitable biocompatible materials, such as a biocompatible shape memory material (SMM). For example, the SMM may be shaped in a manner that allows for a delivery orientation while within the tube set, but may automatically retain the memory shape of the component once deployed into the tissue to close the opening. SMMs have a shape memory effect in which they may be made to remember a particular shape. Once a shape has been remembered, the SMM may be bent out of shape or deformed and then returned to its original shape by unloading from strain or heating. Typically, SMMs may be shape memory alloys (SMA) comprised of metal alloys, or shape memory plastics (SMP) comprised of polymers. The materials may also be referred to as being superelastic.
Usually, an SMA may have an initial shape that may then be configured into a memory shape by heating the SMA and conforming the SMA into the desired memory shape. After the SMA is cooled, the desired memory shape may be retained. This allows for the SMA to be bent, straightened, twisted, compacted, and placed into various contortions by the application of requisite forces; however, after the forces are released, the SMA may be capable of returning to the memory shape. The main types of SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel; nickel-titanium (NiTi) alloys known as nitinol; nickel-titanium platinum; nickel-titanium palladium; and cobalt-chromium-nickel alloys or cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. The temperatures at which the SMA changes its crystallographic structure are characteristic of the alloy, and may be tuned by varying the elemental ratios or by the conditions of manufacture. This may be used to tune the component so that it reverts to the memory shape to close the arteriotomy when deployed at body temperature and when being released from the tube set.
For example, the primary material of a closure element and the like may be of a NiTi alloy that forms superelastic nitinol. In the present case, nitinol materials may be trained to remember a certain shape, retained within the tube set, and then deployed from the tube set so that the tines penetrate the tissue as it returns to its trained shape and closes the opening. Also, additional materials may be added to the nitinol depending on the desired characteristic. The alloy may be utilized having linear elastic properties or non-linear elastic properties.
An SMP is a shape-shifting plastic that may be fashioned into a closure element in accordance with the present disclosure. Also, it may be beneficial to include at least one layer of an SMA and at least one layer of an SMP to form a multilayered body; however, any appropriate combination of materials may be used to form a multilayered device. When an SMP encounters a temperature above the lowest melting point of the individual polymers, the blend makes a transition to a rubbery state. The elastic modulus may change more than two orders of magnitude across the transition temperature (Ttr). As such, an SMP may be formed into a desired shape of an endoprosthesis by heating it above the Ttr, fixing the SMP into the new shape, and cooling the material below Ttr. The SMP may then be arranged into a temporary shape by force and then resume the memory shape once the force has been released. Examples of SMPs include, but are not limited to, biodegradable polymers, such as oligo(ε-caprolactone)diol, oligo(ρ-dioxanone)diol, and non-biodegradable polymers such as, polynorborene, polyisoprene, styrene butadiene, polyurethane-based materials, vinyl acetate-polyester-based compounds, and others yet to be determined. As such, any SMP may be used in accordance with the present disclosure.
The closure element, the delivery sheath, and the like may have at least one layer made of an SMM or suitable superelastic material and other suitable layers may be compressed or restrained in its delivery configuration within the garage tube or inner lumen, and then deployed into the tissue so that it transforms to the trained shape. For example, the closure element may be set in a trained shape that has a relative small diameter. The closure element can then be expanded and moved into engagement with a body lumen wall adjacent a puncture. The closure element can then be allowed to return to the trained state to close the puncture.
Also, a closure element, the delivery sheath or other aspects or components of the closure system may be comprised of a variety of known suitable deformable materials, including stainless steel, silver, platinum, tantalum, palladium, nickel, titanium, nitinol, having tertiary materials (U.S. 2005/0038500, which is incorporated herein by reference, in its entirety), niobium-tantalum alloy optionally doped with a tertiary material (U.S. 2004/0158309, 2007/0276488, and 2008/0312740, which are each incorporated herein by reference, in their entireties) cobalt-chromium alloys, or other known biocompatible materials. Such biocompatible materials may include a suitable biocompatible polymer in addition to or in place of a suitable metal.
In one embodiment, the closure element, the delivery sheath, and the like may be made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. The added ternary element improves the radiopacity of the nitinol.
In one embodiment, the closure element, the delivery sheath, and the like may be made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum.
In further embodiments, the closure element, the delivery sheath, and the like may be made from or be coated with a biocompatible polymer. Examples of such biocompatible polymeric materials may include hydrophilic polymer, hydrophobic polymer biodegradable polymers, bioabsorbable polymers, and monomers thereof. Examples of such polymers may include nylons, poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols, polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcohol copolymers, ethylenevinylalcohol copolymers (EVAL), propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP), combinations thereof, polymers having monomers thereof, or the like.
The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.