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Publication Number
US-9414824-B2
Publication Date
2016-08-16
Expiration Date
Abstract
The present disclosure includes vessel closure devices, systems, and methods. A closure device configured to close an opening in a body lumen may include an elongate member having a distal end and a proximal end. An anchor member may be disposed on the elongate member proximate the distal end of the elongate member. A cap member may also be disposed on the elongate member a distance from the distal end of the elongate member. The anchor member and the cap member cooperate to close the opening in the body lumen.
Core Innovation
The disclosure describes a closure system configured to close an opening in a body lumen. The closure system includes a generally tubular outer member with a distal opening and a proximal opening, a generally tubular intermediate member disposed at least partially within the outer member, and a generally tubular inner member disposed at least partially within the intermediate member, where the inner member includes a lumen. A closure device is disposed at least partially within the outer member and around at least a portion of an outer surface of the inner member extending from a distal end toward a proximal end.
The closure device comprises a suture having a distal end and a proximal end, and a monolithic anchor member connected to the suture proximate the distal end. The monolithic anchor member is elastic such that it conforms to an inner surface of the body lumen, and a knot is affixed to a proximal face of the monolithic anchor member. A cap member is connected to the suture a distance from the distal end, and the cap member is configured to conform to an outer surface of the body lumen, with the anchor member and cap member deformed to close the opening with a convex-like surface of the cap member disposed toward the monolithic anchor member.
The closure system is delivered in a pre-deployed delivery configuration in which the suture extends distally from the distal end of the generally tubular inner member and distal the monolithic anchor. The multi-member tubular architecture can be advanced over a guidewire, and the method claim includes staged deployment comprising anchor deployment, suture tensioning, and cap deployment and advancement to engage distal and proximal lumen-wall surfaces. Optional sealing or obstruction elements, material options, and drug or agent delivery and coatings to promote tissue growth and hemostasis are described.
Claims Coverage
The consolidated claim coverage includes three independent claims. The coverage is grounded by nested tubular members and a closure device using a suture with an elastic monolithic anchor and a deformable cap configured to close a lumen opening in a pre-deployed delivery configuration, with a method claim adding staged deployment steps.
Nested tubular closure system with elastic monolithic anchor and deformable cap
A closure system configured to close an opening in a body lumen, comprising a generally tubular outer member with a distal opening and a proximal opening; a generally tubular intermediate member disposed at least partially within the outer member; a generally tubular inner member disposed at least partially within the intermediate member, the inner member including a lumen; and a closure device disposed at least partially within the outer member and around at least a portion of an outer surface of the inner member extending from a distal end toward a proximal end, the closure device comprising a suture with a monolithic anchor member that is elastic and a cap member deformed to close the opening with a convex-like cap surface disposed toward the monolithic anchor member, wherein the suture extends distally from the distal end of the inner member and distal the monolithic anchor in a pre-deployed delivery configuration.
Nested tubular closure system with suture disposed through the intermediate member
A closure system comprising a generally tubular outer member having a distal opening and a proximal opening; a generally tubular intermediate member disposed at least partially within the outer member; a generally tubular inner member disposed at least partially within the intermediate member, the inner member including a lumen; and a closure device disposed at least partially within the outer member and around at least a portion of an outer surface of the inner member extending from a distal end toward a proximal end, the closure device comprising a suture disposed at least partially through the intermediate member; a monolithic anchor member connected to the suture proximate the distal end and disposed within the outer member distal of the intermediate member and elastic to conform to an inner surface of the body lumen; and a cap member connected to the suture at a distance from the distal end and disposed within the outer member proximal of the anchor member and deformed to close the opening with a convex-like surface disposed toward the monolithic anchor member, wherein the suture extends distally from the distal end of the inner member and distal the monolithic anchor in a pre-deployed delivery configuration.
Method of closing a lumen opening with staged deployment of elastic monolithic anchor and deformable cap
A method of closing an opening in a lumen wall, comprising advancing the distal end of a closure system over a guidewire into a body lumen with an outer tubular member, intermediate tubular member, and inner tubular member including a lumen, and a closure device disposed within the outer member around an outer surface portion of the inner member, the closure device comprising a suture disposed at least partially through the intermediate member, an elastic monolithic anchor conforming to an inner surface of the body lumen, and a cap member deformed to close the opening with a convex-like surface disposed toward the monolithic anchor member, wherein the suture extends distally from the distal end of the inner member and distal the monolithic anchor in a pre-deployed delivery configuration, then deploying the anchor member into the lumen, tensioning the suture to engage the anchor member with a distal surface of the lumen wall, and deploying the cap member and advancing the cap member in a distal direction along the suture to engage a proximal surface of the lumen wall.
Across the independent claims, the core coverage is a nested tubular closure system with a suture carrying an elastic monolithic anchor and a deformable cap, delivered in a pre-deployed configuration where the suture extends distally beyond the inner member and anchor; the method claim adds anchor deployment, suture tensioning, and cap deployment and advancement to engage distal and proximal lumen-wall surfaces.
Stated Advantages
Promotes tissue growth and hemostasis using described drug or agent delivery and coatings.
Includes bioabsorbable or bioresorbable materials, including polymers and bioabsorbable metals.
Documented Applications
Closing an opening in a body lumen, including delivery over a guidewire into a body lumen.
Optionally including a plug configured to partially block a tissue tract near a body lumen opening.
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