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Catheter-based fastener implantation apparatus and methods

Catheter-based fastener implantation apparatus and methods description/claims

This application is a divisional of co-pending U.S. patent application Ser. No. 10/669,881, filed Sep. 24, 2003, entitled “Catheter-Based Fastener Implantation Apparatus and Methods With Implantation Force Resolution, which is a continuation-in-part of U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, and which is also a continuation-in-part of U.S. patent application Ser. No. 10/271,334, filed Oct. 15, 2002 (now U.S. Pat. No. 6,960,217), and which is also a continuation-in-part of U.S. patent application Ser. No. 10/099,149, filed Mar. 15, 2002, which is a divisional of U.S. patent application Ser. No. 09/787,135, filed Sep. 17, 1999, entitled “Endovascular Fastener Applicator,” which claims the benefit of U.S. Provisional Application Ser. No. 60/101,050 filed Sep. 18, 1998.

The invention relates generally to the delivery of a prosthesis to a targeted site within the body, e.g., for the repair of diseased and/or damaged sections of a hollow body organ and/or blood vessel.

The weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture.

For example, aneurysms of the aorta primarily occur in abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality.

Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture. In this procedure, the diseased or damaged section of vessel is removed and a prosthetic graft, made either in a straight of bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthetic grafts for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The grafts are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel. However, these procedures require a large surgical incision and have a high rate of morbidity and mortality. In addition, many patients are unsuitable for this type of major surgery due to other co-morbidities.

Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular prosthesis, which is placed intraluminally. Typically these prosthetic grafts for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These grafts are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel. Unlike open surgical aneurysm repair, intraluminally deployed grafts are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the graft in position. These graft attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.

The invention provides apparatus and methods for implanting a fastener in a targeted body region, e.g., within a hollow body organ or an intraluminal space.

One aspect of the invention provides an intraluminal fastener applier comprising a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body.

In one embodiment, the actuated assembly includes structure that maintains the angle between the driven member and the drive member at about ninety-degrees or less.

In one embodiment, the actuated assembly includes structure that maintains a fixed angle between the driven member and the drive member, which can be, e.g., ninety-degrees or less.

In one embodiment, the actuated assembly includes a control mechanism to articulate the driven member relative to the drive member to adjust the angle.

In one embodiment, stabilization means is associated with the guide body for applying a resolving force in a direction different than the implantation force direction to resolve at least a portion of the implantation force within the hollow body organ.

Another aspect of the invention provides a method that deploys an intraluminal fastener applier hollow body organ. The intraluminal fastener applier comprises a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body.

The method places the driven member into contact with tissue along a side wall of the hollow body while the longitudinal axis of the guide body remains substantially aligned with a long axis of the hollow body organ. The method operates the drive member to impart the implantation force to the driven element in the direction that is at an angle to the longitudinal axis of the guide body, to thereby implant the fastener in the side wall while the guide body remains substantially aligned with the long axis of the hollow body organ.

In one embodiment, the method applies a resolving force at or near the drive member to resolve within the hollow body organ at least a portion of the implantation force.

In one embodiment, the guide body includes a catheter body having a column strength that applies a resolving force in a direction different than the implantation force direction to resolve at least a portion of the implantation force within the hollow body organ.

Another aspect of the invention provides a method that advances an intraluminal fastener applier to a location within a prosthesis that has been deployed at a target site along a side wall of an aorta where a diseased or damaged section exists. The intraluminal fastener applier comprises a guide body having a longitudinal axis sized and configured for intraluminal deployment in a hollow body organ. The fastener applier includes an actuated assembly carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body.

• Provisional Patent
• Utility Patent

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