Apparatus and method for sealing a vessel puncture opening

The present disclosure generally relates to medical devices and methods, and more particularly to apparatus and methods for sealing a puncture opening after a surgical procedure.

A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involved accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.

Traditionally, external pressure has been applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface and maybe unsuitable amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.

More recently, devices have been proposed to promote hemostasis directly at a site of a vascular puncture. One class of such puncture sealing devices features an intraluminal anchor which is placed within the blood vessel and seals against an inside surface of the vessel puncture. The intraluminal plug maybe used in combination with a sealing material positioned on the outside of the blood vessel, such as collagen. Sealing devices of this type are disclosed in U.S. Pat. Nos. 4,852,568; 4,890,612; 5,021,059; and 5,061,274. Anther approach to subcutaneous blood vessel puncture closure involves the delivery of non-absorbable tissue adhesives, such as cyanoacrylate, to the perforation site. Such a system is disclosed in U.S. Pat. No. 5,383,899.

The use of these conventional devices presents several drawbacks, including: (1) Complex and difficult applications; (2) Partial occlusion of the blood vessel by the anchor when placed properly; and (3) Complete blockage of the blood vessel or a branch of the blood vessel by the anchor if placed improperly.

More recently, sealing methods have been disclosed which use an energy source, such as heat, to seal the puncture. These methods are a significant departure from the well-known pressure- or plug-based methods and can require a practitioner to learn an entirely new procedure using unfamiliar devices.

Accordingly, it would be desirable to provide apparatus that reliably seals vessel puncture openings using methods that are already familiar to the practitioner.

A device for sealing a puncture opening in a wall of a blood vessel may include a base frame movable between a delivery configuration, in which the base frame is retracted to have a relatively smaller overall profile, and a deployed configuration, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration, and is configured to have a first stable state corresponding to the deployed configuration. A sealing section may be coupled to the base frame and have an initial configuration which permits fluid flow through the sealing section and a barrier configuration which prevents fluid flow through the sealing section. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.

In a refinement a device for sealing a puncture opening in a wall of a blood vessel may include a base frame movable between a delivery configuration, in which the base frame is retracted to have a relatively smaller overall profile, and a deployed configuration, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration, and is configured to have a first stable state corresponding to the deployed configuration. A sealing section is coupled to the base frame and includes a bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.

In a further refinement, a device for sealing a puncture opening in a wall of a blood vessel may include a base frame including a first bi-stable material having a first stable state corresponding to a delivery configuration of the base frame, in which the base frame is retracted to have a relatively smaller overall profile, and a second stable state corresponding to a deployed configuration of the base frame, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration. A sealing section is coupled to the base frame and includes a second bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of this disclosure will become more readily appreciated as the same becomes better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a side-elevation view, in cross-section, of an introducer inserted into a blood vessel during a medical procedure;

FIG. 2 is a side-elevation view, in cross-section, of the introducer of FIG. 1 being used to deliver a puncture sealing stent in a delivery configuration, made in accordance with this disclosure;

FIG. 3 is a side elevation view in cross-section, of the stent of FIG. 2 in a deployed configuration;

FIGS. 4A and 4B are schematic illustrations showing filaments of the puncture sealing stent in delivery and deployed configurations, respectively;

FIG. 5 is a perspective view of a further embodiment of a puncture sealing stent in a delivery configuration, made in accordance with the present disclosure;

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