US20100094400A1 - Devices, systems, and methods for prosthesis delivery and implantation - Google Patents

Abstract

Devices, systems, and methods use a catheter device sized and configured for introduction to a targeted site in a hollow body organ or blood vessel. The catheter device includes a first release mechanisms coupled to the prosthesis to secure at least one region of the prosthesis to the catheter shaft, and a second release mechanism coupled to the prosthesis in cooperation with the first release mechanism to prevent full release of the at least one region of the at least one region of the prosthesis from the catheter shaft after actuation of the first release mechanism. A fastening device sized and configured for introduction to the targeted site in the hollow body organ or blood vessel occupied by the catheter device, includes an actuator to deploy a fastener in the at least one region of the prosthesis after actuation of the first release mechanism and before actuation of the second release mechanism.

Description

RELATED APPLICATIONS
• This application is a continuation of co-pending U.S. patent application Ser. No. 11/255,116, filed Oct. 20, 2005, which is a continuation-in-part of (i) U.S. patent application Ser. No. 11/254,619 filed Oct. 20, 2005, and entitled “Devices, Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region,” which is incorporated herein by reference; (ii) U.S. patent application Ser. No. 10/692,283, filed Oct. 23, 2003, and entitled “Prosthesis Delivery Systems and Methods,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/488,753, filed Jul. 21, 2003, and entitled “Endoprosthesis Delivery Systems and Methods”; (iii) U.S. patent application Ser. No. 10/786,465, filed Feb. 25, 2004, and entitled “Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ”; (iv) U.S. patent application Ser. No. 11/166,428, filed Jun. 24, 2005, entitled “Multi-Lumen Prosthesis Systems and Methods,” which is a division of U.S. patent application Ser. No. 10/693,255, filed 24 Oct. 2003 (now U.S. Pat. No. 6,929,661), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/489,011, filed Jul. 21, 2003, and entitled “Bifurcated Prosthesis Systems and Methods”; (v) U.S. patent application Ser. No. 10/307,226, filed 29 Nov. 2002, and entitled “Intraluminal Prosthesis Attachment Systems, and Methods”; (vi) U.S. patent application Ser. No. 10/669,881, entitled “Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution”; (vii) U.S. patent application Ser. No. 11/166,411, filed Jun. 24, 2005, entitled “Endovascular Aneurysm Repair System,” which is a division of U.S. patent application Ser. No. 10/271,334, filed 15 Oct. 2002 (now U.S. Pat. No. 6,960,217), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/333,937, filed 28 Nov. 2001, and entitled “Endovascular Aneurysm Repair System.” Each of the preceding applications is incorporated herein by reference.
FIELD OF THE INVENTION
• The invention relates generally to devices, systems, and methods for the delivery and implantation 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.
BACKGROUND OF THE INVENTION
• 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 the 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 prosthesis, made either in a straight or bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthetic prosthesis for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The prosthesis 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 prostheses for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These prostheses 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 prostheses 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 prosthesis in position. These prosthesis attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.
• Accordingly, there is a need for improved prosthesis delivery devices, systems, and methods that deliver a prosthetic graft to a body lumen, the prosthesis being able to adapt to changes in aneurysm morphology and able to be deployed safely and without damage to the native vessel.
SUMMARY OF THE INVENTION
• The devices, systems, and methods for delivering and implanting radially expandable prostheses in the body lumens and hollow body organ are described. In particular, the present invention provides improved devices, systems, and methods for implanting vascular prostheses into blood vessels, including both arterial and venous systems. In the exemplary embodiments, prostheses are placed in vasculature to reinforce aneurysms, particularly abdominal aortic aneurysms.
• According to one aspect of the invention, devices, systems and methods position a deployment catheter at a targeted site in a hollow body organ or blood vessel. The deployment catheter carries an expandable endovascular prosthesis. The devices, systems and methods actuate a first release mechanism on the deployment catheter to allow at least some expansion of at least one region of the prosthesis at the targeted site without fully releasing the one region of the prosthesis from the deployment catheter. After actuating the first release mechanism, the devices, systems and methods apply a fastener to fasten the at least one region of the prosthesis to the targeted site. After applying the fastener, the devices, systems and methods actuate a second release mechanism on the deployment catheter to fully release the at least one region of the prosthesis from the deployment catheter.
• According to another aspect of the invention, devices, systems and methods position a deployment catheter at a targeted site in a hollow body organ or blood vessel. The deployment catheter carries an expandable endovascular prosthesis. The devices, systems and methods actuate a first release mechanism on the deployment catheter to allow at least some expansion of the proximal region of the prosthesis at the targeted site without fully releasing the proximal end of the prosthesis from the deployment catheter. After actuating the first release mechanism, the devices, systems and methods apply a fastener to fasten the proximal end the prosthesis to the targeted site. After applying the fastener, the devices, systems and methods actuate, a second release mechanism on the deployment catheter to fully release the proximal end of the prosthesis from the deployment catheter. After applying the fastener, the devices, systems and methods actuate a third release mechanism on the deployment catheter to fully release the distal end of the prosthesis from the deployment catheter.
• The devices, systems, and methods make possible longitudinal and/or rotational adjustment of the position and orientation of the prosthesis before prior to applying a fastener. The devices, systems, and methods also make possible retaining control of the prosthesis, both proximally and distally, while a fastener is applied.
• Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of one embodiment of a prosthesis deployment catheter shown positioned within an abdominal aortic aneurysm.
• FIG. 2 is a perspective view of one embodiment of the deployment of a prosthesis within the aneurysm ofFIG. 1, with the jacket partially retracted.
• FIG. 3 is a perspective view of one embodiment of the deployment of a prosthesis within the aneurysm ofFIG. 1, with the jacket fully retracted and showing radial expansion of the proximal end.
• FIG. 4 is a perspective view of one embodiment of the completed deployment of a multi-lumen prosthesis within the aneurysm ofFIG. 1.
• FIG. 5 is a perspective view of an alternative embodiment of the completed deployment of a single, lumen prosthesis within the aneurysm ofFIG. 1.
• FIG. 6 is a side view of the multi-lumen prosthesis assembly that embodies features of the invention, the multi-lumen prosthesis assembly shown with lumen extensions.
• FIG. 7A is a side view of the main body component of the multi-lumen prosthesis assembly.
• FIG. 7B is an enlarged view showing detail of the distal stent curved apices of the multi-lumen prosthesis shown inFIG. 7A.
• FIG. 7C is a side view of one embodiment of the prosthesis septum, showing stitches and weaving to form the septum.
• FIG. 7D is a side view of an alternative embodiment of the main body component of the multi-lumen prosthesis assembly ofFIG. 7A, showing the main body prosthesis having a second lumen extending beyond the first lumen.
• FIG. 8A is a section view of the distal end of the main body component of the multi-lumen prosthesis taken generally alongline8A-8A ofFIG. 6.
• FIG. 8B is a section view of the proximal end of the main body component of the multi-lumen prosthesis taken generally alongline8B-8B ofFIG. 6.
• FIG. 9A is a side view of a prosthesis lumen extension.
• FIG. 9B is an enlarged view showing detail of the securing stent curved apices of the lumen extension shown inFIG. 9A.
• FIG. 9C is a side view of one extension lumen coupled to the main body component of the multi-lumen prosthesis.
• FIG. 9D is an enlarged view showing detail of the curved apices of both the securing stent of the lumen extension coupled to the distal stent of the main body prosthesis, as shown inFIG. 9C.
• FIG. 10A is a side view of an alternative embodiment of the prosthesis lumen extension ofFIG. 9A, and shows securing stents without deflected apices.
• FIG. 10B is an enlarged view showing detail of the securing stents of the lumen extension shown inFIG. 10A.
• FIG. 10C is a side view showing the alternative embodiment of the prosthesis lumen extension ofFIG. 10A coupled to the main body component of the multi-lumen prosthesis.
• FIG. 10D is an enlarged view showing detail of the securing stents of the alternative embodiment of the lumen extension coupled to the distal stent of the main body prosthesis, as shown inFIG. 10C.
• FIG. 11 is a perspective view of a prosthesis deployment catheter that embodies features of the invention.
• FIG. 12 is a side view of one embodiment of the proximal end of the deployment catheter ofFIG. 11.
• FIG. 13 is a side view of the proximal end of the deployment catheter ofFIG. 11, and showing a jacket covering components of the deployment catheter.
• FIG. 14A is a side view of the proximal end of the deployment catheter ofFIG. 11, and showing the jacket covering the main body component of the multi-lumen prosthesis prior to deployment.
• FIG. 14B is a perspective view of an alternative embodiment of the deployment catheter jacket ofFIG. 11 showing structural reinforcement.
• FIG. 15 is a section view of the lumens in the central shaft deployment catheter taken generally along line15-15 ofFIG. 12.
• FIG. 16 is a side view of the catheter tip and central shaft of the deployment catheter showing the catheter tip lumen and central shaft lumen.
• FIG. 17 is a perspective view of the main body component of the multi-lumen prosthesis positioned on the proximal end of the deployment catheter prior to deployment, and showing the first proximal retaining means in a compressed condition.
• FIG. 18A is a side view of one embodiment of a suture loop path around the main body component of the multi-lumen prosthesis.
• FIG. 18B is a side view of an alternative embodiment of a suture loop path around the multi-lumen prosthesis ofFIG. 18A, showing multiple suture loops.
• FIG. 19 is a perspective view of the main body component of the multi-lumen prosthesis positioned on the proximal end of the deployment catheter showing the first proximal retaining means released and the proximal end of the main body component expanded.
• FIG. 20 is a side view of a portion of the distal end of the deployment catheter showing one embodiment of a first proximal releasing means and a first proximal release wire.
• FIG. 21 is a side view of a portion of the proximal end of the deployment catheter showing detail of the first proximal release hub and central shaft lumens.
• FIG. 22 is a side view of a portion of the distal end of the deployment catheter showing detail of one embodiment of the second proximal releasing means.
• FIG. 23 is a side view showing detail of the stabilizing arms in a pre-deployment configuration, the proximal ends of the stabilizing arms being arched back generally toward a first proximal release hub.
• FIG. 24 is a side view of the stabilizing arms ofFIG. 23 in a pre-deployment configuration with the deployment catheter and multi-lumen prosthesis positioned within the descending aorta, and showing the proximal ends of the stabilizing arms coupled to the proximal end of the main body prosthesis.
• FIG. 25 is a side view showing detail of stabilizing arms coupled to the proximal end of the main body prosthesis, showing the second proximal release wire stitched or otherwise extended through a stabilizing arm aperture and through the prosthesis material, releasably securing the stabilizing arms to the main body prosthesis.
• FIG. 26 is a side view of the stabilizing arms ofFIG. 23 in a post-deployment configuration with the deployment catheter and multi-lumen prosthesis positioned within the descending aorta, and showing the proximal ends of the stabilizing arms released from the proximal end of the main body prosthesis.
• FIG. 27 is a section view of the proximal end of the deployment catheter shaft taken generally along line27-27 ofFIG. 23.
• FIG. 28 is a side view of the distal end of the main body prosthesis positioned on the deployment catheter central shaft prior to deployment of the distal retaining means.
• FIG. 29A is a side view of one embodiment of a suture loop path around the distal end of the multi-lumen prosthesis.
• FIG. 29B is a side view of an alternative embodiment of a suture loop path around the distal end of the multi-lumen prosthesis ofFIG. 29A, showing multiple suture loops.
• FIG. 30 is a side view of the distal end of the main body component of the multi-lumen prosthesis positioned on the deployment catheter shaft ofFIG. 28, showing the distal retaining means released and the distal end of the main body component expanded.
• FIG. 31 is a side view of a portion of the proximal end of the deployment catheter showing detail of the distal releasing means and central shaft lumens.
• FIG. 32 is a side view of an alternative embodiment of the distal end of the main body prosthesis positioned on the deployment catheter central shaft prior to deployment of the distal retaining means.
• FIG. 33 is a side view of the distal end of the main body component of the multi-lumen prosthesis positioned on the deployment catheter shaft ofFIG. 32, showing the alternative distal retaining means released and the distal end of the main body component expanded.
• FIG. 34 is a perspective view of a first side of the deployment catheter handle assembly that embodies features of the invention.
• FIG. 35 is a perspective view of a second side of the deployment catheter handle assembly that embodies features of the invention.
• FIG. 36 is a top view of the deployment catheter handle assembly ofFIG. 34.
• FIG. 37 is a section view of the deployment catheter handle assembly ofFIG. 34 taken generally along line37-37 ofFIG. 36.
• FIG. 38 is a section view of the deployment catheter handle assembly ofFIG. 34 taken generally along line38-38 ofFIG. 36.
• FIG. 39 is a top view of a portion of the deployment catheter handle assembly ofFIG. 34 showing the jacket retraction means prior to jacket retraction.
• FIG. 40 is a top view of a portion of the deployment catheter handle assembly ofFIG. 39 showing the jacket retraction means after the jacket has been retracted.
• FIG. 41 is a perspective view of a second side of one embodiment of a rack and pinion mechanism and a release system positioned within the deployment catheter handle assembly.
• FIG. 42 is a perspective view of a second side of one embodiment of a rack and pinion mechanism and a release system positioned within the deployment catheter handle assembly.
• FIG. 43 is a perspective view showing detail of the release system positioned within the deployment catheter handle assembly.
• FIG. 44A is a perspective view of a lumen extension deployment catheter that embodies features of the invention.
• FIG. 44B is a perspective view of the lumen extension deployment catheter shown inFIG. 44A, and showing a stationary outer jacket and a hemostatic valve.
• FIG. 45A is a side view of one embodiment of the proximal end of the lumen extension deployment catheter ofFIG. 44.
• FIG. 45B is a side view of an alternative embodiment of the proximal end of the lumen extension deployment catheter ofFIG. 45A, and shows an optional distal retaining and releasing means.
• FIG. 46A is a side view of a proximal section of the lumen extension deployment catheter ofFIG. 45A, and showing a jacket covering the lumen extension positioned on the catheter shaft prior to deployment.
• FIG. 46B is a side view of an alternative embodiment of a proximal section of the lumen extension deployment catheter ofFIG. 45B, and showing a jacket covering the lumen extension positioned on the catheter shaft prior to deployment and including a distal retaining means.
• FIG. 46C is a perspective view of an alternative embodiment of the lumen extension deployment catheter jacket ofFIG. 44 showing structural reinforcement.
• FIG. 47A is a section view of the lumen extension deployment catheter shaft ofFIG. 45A taken generally alongline47A-47A ofFIG. 45A.
• FIG. 47B is a section view of an alternative embodiment of the lumen extension deployment catheter shaft ofFIG. 45B taken generally alongline47B-47B ofFIG. 45B.
• FIG. 48A is a side view of one embodiment of a suture loop path around the proximal end of the lumen extension.
• FIG. 48B is a side view of one embodiment of a suture loop path around the distal end of the lumen extension.
• FIG. 48C is a side view of an alternative embodiment of a suture loop path around the proximal or distal end of the lumen extension shown inFIGS. 48A and 48B, and shows multiple suture loops.
• FIG. 49A is side view of the lumen extension deployment catheter handle assembly ofFIG. 44.
• FIG. 49B is a side view of an alternative embodiment of the lumen extension deployment catheter handle assembly ofFIG. 44, and showing and additional slide knob for an optional distal releasing means.
• FIG. 50 is top view of the lumen extension deployment catheter handle assembly ofFIG. 44.
• FIG. 51 is a perspective view of one embodiment of the release system positioned within the handle assembly of the lumen extension deployment catheter.
• FIG. 52 is an enlarged perspective view of one embodiment of a helical fastener that can be used in association with a fastener tool or device shown inFIG. 53.
• FIG. 53 is a perspective view of a fastener tool that embodies features of the invention.
• FIG. 54 is a perspective view of the handle assembly of the fastener tool ofFIG. 53.
• FIG. 55 is a perspective view of a steerable guide device that embodies features of the invention.
• FIG. 56 is a perspective view of the handle assembly of the steerable guide device ofFIG. 55.
• FIG. 57 is a perspective view of an obturator or dilator that may be used in conjunction with the steerable guide device ofFIG. 55.
• FIG. 58 is a perspective view of one embodiment of a prosthesis deployment catheter shown positioned within an abdominal aortic aneurysm.
• FIG. 59 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, with the jacket partially retracted.
• FIG. 60 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, with the jacket fully retracted but prior to the release of the proximal or distal retaining means.
• FIG. 61 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, with the jacket fully retracted but prior to the release of the proximal or distal retaining means and showing an alternative embodiment of the distal retaining means.
• FIG. 62 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the first proximal retaining means released and the proximal end of the main body component expanded.
• FIG. 63 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing a second guide wire positioned through the main body prosthesis lumen.
• FIG. 64 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the steerable guide and obturator positioned on the second guide wire and through the main body prosthesis lumen.
• FIG. 65 is an enlarged perspective view of the deployment of the main body component of the multi-lumen prosthesis within the descending aorta, and showing the steerable guide device and the fastener tool just prior to fastening a helical fastener through the prosthesis material and into tissue.
• FIG. 66 is an enlarged perspective view of the deployment of the main body component of the multi-lumen prosthesis within the descending aorta, and showing the steerable guide device and the fastener tool just after fastening a helical fastener through the prosthesis material and into tissue.
• FIG. 67 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the deflected end of the steerable guide device and the fastener tool after being repositioned for deployment of an additional helical fastener.
• FIG. 68 is an enlarged perspective view of the deployment of the main body component of the multi-lumen prosthesis within the descending aorta, and showing one embodiment of a fastener deployment pattern.
• FIG. 69 is a perspective view of the deployment of a lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the lumen extension catheter being positioned partially within a prosthesis lumen.
• FIG. 70 is a perspective view of the deployment of the lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the jacket retracted from the lumen extension deployment catheter and prior to the release of a proximal retaining means.
• FIG. 71 is a perspective view of the deployment of the lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the lumen extension coupled to and fully expanded within a lumen of the main body component after the release of the proximal retaining means.
• FIG. 72 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the lumen extension deployment catheter removed and the stabilizing arms of the main body deployment catheter released.
• FIG. 73 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the distal retaining means released and the distal end of the main body prosthesis expanded.
• FIG. 74 is a perspective view of the deployment of the main body component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the withdrawal of the rejacketed main body deployment catheter over the first guide wire.
• FIG. 75 is a perspective view of the deployment of a second lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the lumen extension catheter being positioned partially within a prosthesis lumen.
• FIG. 76 is a perspective view of the deployment of the second lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the jacket retracted from the lumen extension deployment catheter and prior to the release of a proximal retaining means.
• FIG. 77 is a perspective view of the deployment of the second lumen extension component of the multi-lumen prosthesis within the aneurysm ofFIG. 58, and showing the second lumen extension coupled to and fully expanded within a lumen of the main body component after the release of the proximal retaining means.
• FIG. 78 is a perspective view of one embodiment of the completed deployment of the multi-lumen prosthesis within the aneurysm ofFIG. 58.
• FIG. 79A is an enlarged perspective view of an alternative embodiment of a helical fastener that can be used in association with a fastener tool or device shown inFIG. 53.
• FIG. 79B is an enlarged top view of the alternative fastener ofFIG. 79A showing a “D” shape.
• FIG. 80 is an enlarged perspective view of the deployment of the main body component of the multi-lumen prosthesis within the descending aorta, and showing the steerable guide device and the fastener tool having an alternative fastener driver just prior to fastening the helical fastener ofFIG. 79A through the prosthesis material and into tissue.
• FIG. 81 is an enlarged perspective view of the fastener driver and fastener ofFIG. 80, and showing the fastener rotating off of the fastener carrier.
• FIG. 82A is an enlarged side view of the fastener driver ofFIG. 80, and showing a fastener positioned on the fastener carrier and within a threaded fastener housing, and also showing the fastener latch feature.
• FIG. 82B is an enlarged side view of the fastener driver ofFIG. 80, and showing a fastener on the carrier and rotating off the carrier and showing the pivoting of the fastener latch.
• FIG. 82C is an enlarged side view of the fastener driver ofFIG. 80, and showing a fastener positioned on the fastener carrier and within a threaded fastener housing, and also showing an alternative fastener latch feature.
• FIG. 83 is a perspective view of one embodiment of a fastener cassette with fasteners releasably positioned with a fastener receptacle.
• FIG. 84 is a perspective view of an alternative embodiment of a fastener cassette ofFIG. 82.
• FIG. 85 is a perspective view showing the fastener tool positioned on a fastener cassette for removal of a fastener from the cassette and positioning the fastener within the fastener driver.
• FIG. 86 is a perspective view showing the fastener tool with a fastener positioned in the fastener driver and ready for deployment.
DETAILED DESCRIPTION OF THE INVENTION
• This Specification discloses various catheter-based devices, systems, and methods for delivering and implanting radially expandable prostheses in the body lumens. For example, the various aspects of the invention have application in procedures requiring the repair of diseased and/or damaged sections of a hollow body organ and/or blood vessel. The devices, systems, and methods that embody features of the invention are also adaptable for use with systems and surgical techniques that are not necessarily catheter-based.
• The devices, systems, and methods are particularly well suited for treating aneurysms of the aorta that primarily occur in the abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation, as well as aneurysms that also occur in the thoracic region between the aortic arch and renal arteries. For this reason, the devices, systems, and methods will be described in this context. Still, it should be appreciated that the disclosed devices, systems, and methods are applicable for use in treating other dysfunctions elsewhere in the body, which are not necessarily aorta-related.
I. OVERVIEW
• FIG. 1 depicts a portion of the descending aorta and shows an abdominalaortic aneurysm20. For the purposes of illustration,FIG. 1 shows the targeted site for delivery and implantation of a prosthesis as being within the abdominalaortic aneurysm20. It is to be appreciated that the targeted site can also be elsewhere in the body. In the illustrated arrangement, the prosthesis takes the form of an endovascular graft.
• In order to provide a consistent orientation for the devices, systems, and methods described herein, the terms proximal or cephalad will be used to describe a relation or orientation toward the head or heart, and the terms distal or caudal will be used to describe a position or orientation toward the feet or away from the heart. Therefore, the devices, systems, and methods can be described as having a proximal or cephalad component and a distal or caudal component. The use of these terms also applies to the implantation apparatus as used in the implantation process described, i.e., the deployment catheter handle is distal or caudal as the handle of the deployment catheter is oriented toward the feet and away from the heart.
• The proximal orcephalad end202 of aprosthesis deployment catheter200 can be seen inFIG. 1 positioned over a first guide wire30 (the guide wire being previously positioned) and extending through at least a portion of the abdominalaortic aneurysm20. Thedeployment catheter200 carries the main body of the prosthesis120 (seeFIG. 2), which is placed at the targeted site, e.g., by radial expansion of the main body prosthesis120 (seeFIG. 3). After expansion of themain body prosthesis120, one or more fasteners402 (seeFIG. 4) may be introduced by afastener device400 to anchor theproximal end108 of the main body prosthesis, in place.
• FIG. 2 depicts the initial stage of themain body prosthesis120 deployment at the targeted site. While the deployment method can vary, in the illustrated embodiment, thedelivery catheter200 has a movable jacket orouter sheath210, which overlays themain body prosthesis120. When theouter jacket210 is pulled distally, or in a caudal direction, themain body prosthesis120 is exposed but may remain in an undeployed configuration until releasing means has been activated. Once the releasing means has been activated, the main body prosthesis or a portion(s) of themain body prosthesis120 is free to radially expand, thereby enlarging to contact at least a portion of the internal walls of the blood vessel. The prosthesis deployment process is continued, including the deployment of one or more lumen extensions, until a multi-lumen orbifurcated prosthesis100 is fully deployed within the vessel, as can be seen inFIG. 4 and will be described in greater detail later.
• It is to be understood that the terms prosthesis and prostheses both can mean an independent component, or multiple components coupled together, or multiple components not necessarily coupled together. The prosthesis may be either coupled together at or near the targeted site, or exterior the body, or a combination of both.
• In a desirable embodiment, the prosthesis, is a multi-lumen prosthesis. In an alternative embodiment, the prosthesis is a straight prosthesis. Theprosthesis100 may be self-expanding, or, theprosthesis100 can utilize an expanding member, such as a balloon or mechanical expander.FIG. 4 depicts a completely deployed multi-lumen orbifurcated prosthesis100 that is sized and configured to be positioned within the aorta and extend across the aneurysm and into the contralateral iliac artery and the ipsilateral iliac artery.FIG. 5 depicts a completely deployedstraight prosthesis50.
• It is to be appreciated that one ormore fasteners402 can be introduced into themulti-lumen prosthesis100 to anchor themain body120 and/orlumen extensions140 in place at different times or at the same time during the procedure.
II. GENERAL METHODS OF ENDOVASCULAR IMPLANTATION
• The prosthesis orprostheses100 as just described lend themselves to implantation in a hollow organ in various ways. The prosthesis may be implanted using catheter-based technology via a peripheral intravascular access site, such as in the femoral artery, optionally with the assistance of image guidance. Image guidance includes but is not limited to fluoroscopy, ultrasound, magnetic resonance, computed tomography, or combinations thereof. Alternatively, the prosthesis can be implanted, e.g., in an open chest surgical procedure.
• FIGS. 58 to 78 show a representative embodiment of the deployment of a prosthesis of the type shown inFIG. 4 by a percutaneous, catheter-based procedure. Percutaneous vascular access is achieved by conventional methods into the femoral artery, for example.
• The implantation of themulti-lumen prosthesis100 is first described here in a number of general steps. The multi-lumen prosthesis and each of the various tools used to implant the prosthesis are then described with additional detail below. Themulti-lumen prosthesis100 is described in section III and the various implantation apparatus are described in section IV. Additionally, the general implantation steps are then described again with additional detail below in section V.
• A first implantation step can be generally described as deploying themain body120 of the prosthesis. Thedeployment catheter200 is positioned within theaortic aneurysm20 and the main body of the prosthesis is allowed to deploy. Proximal and distal retaining means hold the main body prosthesis in a predetermined relationship to theproximal end202 of the deployment catheter. By activating a proximal releasing means, theproximal end108 of themain body prosthesis120 may be partially or fully released from the deployment catheter shaft so as to allow theproximal stent130 to expand to contact the aorta or a portion of the aorta. At this step the prosthesis may not be fully released from the deployment catheter. Themain body prosthesis120 may be attached to thedeployment catheter200 through a second proximal retaining means. Theproximal end108 or other areas of themain body prosthesis120 is fastened to the vessel wall to resist axial migration of the prosthesis.
• Next, anextension catheter350 carrying a firstprosthesis lumen extension140 is guided through the vasculature and to themain body prosthesis120. The first lumen extension is telescopically fitted within thesecond lumen128 of themain body prosthesis120 and allowed to radially expand. The extension catheter is then removed, leaving thelumen extension140 coupled to themain body prosthesis120 and extending into the contralateral iliac artery.
• If themain body prosthesis120 is attached to thedeployment catheter200 through a second proximal retaining means, a second releasing means is activated to allow theproximal end108 of themain body prosthesis120 to release from thedeployment catheter shaft216. The distal releasing means is then activated, allowing thedistal end110 of themain body prosthesis120 to release from thedeployment catheter shaft216 and radially expand. Thedeployment catheter200 is then removed from the body.
• Lastly, theextension catheter350 carrying a secondprosthesis lumen extension140 is guided through the vasculature and to themain body prosthesis120. Thesecond lumen extension140 is telescopically fitted within thefirst lumen126 of the main body prosthesis and allowed to radially expand. Theextension catheter350 is then removed, leaving thelumen extension140 coupled to themain body prosthesis120 and extending into the ipsilateral iliac artery. Themulti-lumen prosthesis100 is now fully deployed across the aortic aneurysm.
III. MULTI-LUMEN PROSTHESIS ASSEMBLY
• FIG. 6 shows amulti-lumen prosthesis assembly100 that embodies features of the invention. In the illustrated embodiment, themulti-lumen prosthesis assembly100 comprises amain body component120 and at least onelumen extension140, desirably two lumen extensions.
• Themain body component120 is sized and configured to fit within a hollow body organ and/or a blood vessel. As described in this Specification, the targeted site of deployment is within the aorta adjacent the renal arteries, as will be described in greater detail later. However, this targeted site of deployment is selected for purposes of illustrating the features of theprosthesis100, and is not intended to be limiting.
• Referring toFIG. 7A, themain body component120 has a proximal anddistal end108,110, and includes an interior communicating with aproximal opening122 for fluid flow into or from the prosthesis. Themain body component120 includes aseptum124 within its interior. The length of theseptum124 within theprosthesis120 can vary. In the illustrated embodiment, theseptum124 does hot extend along the entire length of themain body component120, but is spaced a distance from theproximal opening122. In the illustrated arrangement, theseptum124 comprises a longitudinal seam. The seam can be formed by coupling the opposing surfaces together (i.e., the front and back) of the prosthesis material112 (which is typically a fabric) by sewing, heat bonding, stitching or weaving, for example, or any combination. The coupling of the opposing surfaces together thereby creates a septum or shared, common wall between two lumens, thefirst lumen126 and the second lumen128 (seeFIGS. 8A and 8B). Typically theseam124 would be located along the midline of the main body to create two equallysized lumens126 and128. However, the location of theseam124 could be moved, if different sized lumens were desired. In one embodiment shown inFIG. 7C, theseptum124 is formed by a stitch(s)131 at the septum'sproximal end121, a stitch(s)133 at the septumsdistal end123, and a weave(s)135 in-between thestitches131,133 at the septum'sproximal end121 anddistal end123. The combination of stitches and weaving, for example, provides added stability to theseptum124.
• Theseptum124 transforms at least a portion of the interior of themain body component120 into the multi-lumen flow channel configuration. In the illustrated embodiment, the multi-lumen flow channel configuration comprises dual first and secondinterior lumens126 and128. Due to theseptum124, the dual first and secondinterior lumens126 and128 of the multi-lumen flow channel configuration do not form branched or divergent lumens. The shared common wall or seam (the septum124) prevents divergence and maintains thelumens126 and128 in a non-divergent, generally parallel flow relationship (asFIGS. 8A and 8B show).
• In the illustrated arrangement, theseptum124 runs generally along the mid-line of themain body component120, making the multi-lumen flow channel configuration within themain body component120 essentially symmetric. However, it should be appreciated that theseptum124 could form a non-symmetric multi-lumen flow channel configuration. It should also be appreciated that multiple septums can be present within the interior, transforming the interior of themain body component120 into several flow lumens. The length of the septum can vary. In a representative embodiment, theseptum124 is typically greater than 10 mm in length and not less than 5 mm in length.
• In the illustrated embodiment, thefirst lumen126 defines a flow channel sized and configured to reach a targeted destination or source spaced a defined distance from theproximal opening122, while the truncatedsecond lumen128 communicates with generally the same targeted destination as theproximal opening122 of themain body component120 itself. Furthermore, theseptum124 is sized and configured to accommodate the coupling of aflow channel extension140 to thefirst lumen126 and to the truncatedsecond lumen128, to likewise extend their reach to another targeted source or destination spaced from theproximal opening122, if desired.
• Thesecond lumen128 is truncated along at least a portion of theseptum124. As a result, thedistal opening127 of thefirst lumen126 can be said to extend beyond thedistal opening129 of thesecond lumen128. Still, the shared common wall (the septum124) prevents divergence and maintains thelumens126 and128 in a non-divergent, generally parallel flow relationship. It is to be appreciated that the first andsecond lumens126,128 may be reversed, i.e., thesecond lumen128 may extend beyond the first lumen126 (seeFIG. 7D).
• In this arrangement, themulti-lumen prosthesis assembly100 desirably includes a first and second flow channel lumen extension140 (seeFIG. 6). The first andsecond lumen extensions140 desirably comprise the same construction, i.e., they are duplicates of each other. Referring toFIG. 9A, thelumen extension140 includes aproximal end142 that is sized and configured to be telescopically fitted within thefirst lumen126 and/or the truncatedsecond lumen128 of themain body component120. Thedistal end144 of thelumen extension140 is sized and configured to extend the reach of thefirst lumen126 and the truncatedsecond lumen128 to another targeted destination or source spaced a defined distance from the main body componentproximal opening122. As a result, a portion of the extendedsecond lumen128 is joined to thefirst lumen126 by theseptum124, and a portion of the extendedsecond lumen128 is not joined by theseptum124 to thelumen extension140 of thefirst lumen126.
• Both thefirst lumen126 and the truncatedsecond lumen128 of themain body component120, which is joined by theseptum124 to thefirst lumen126, provide an interface region or socket that is fully enclosed within the body of themain body component120 itself. Thefirst lumen126 and the truncatedsecond lumen128 are therefore not prone to kinking or twisting or other kinds of movement independent of themain body component120. Passage of a guide wire through thefirst lumen126 or thesecond lumen128 can occur unimpeded.
• Being telescopically fitted within the interface region or socket and enclosed within themain body component120, the mechanical properties of thelumen extension140 are supplemented by the structural support and integrity of themain body component120 itself, and vice versa. Coupled together, themain body component120 and thelumen extension140 provide enhanced resistance to migration and/or separation of thelumen extension140 from themain body component120. Seated within the enclosed interface region, thelumen extension140 is peripherally sealed within themain body component120 to resist leaks or seepage of fluids around thelumen extension140. Theseptum124 can be tapered, curved, wavy, or otherwise non-linear to enhance the connection between thelumen extension140 and themain body component120.
• In one illustrated use (seeFIG. 3), themain body component120 can be deployed in the aorta in the region of the bifurcation of the first and second iliac, or ipsilateral and contralateral iliac arteries. When themain body prosthesis120 is deployed, both thefirst lumen126 and thesecond lumen128 remains in communication with the aorta. After themain body component120 is deployed, thefirst lumen extension140 can be fitted within thedistal opening127 of thefirst lumen126, and thesecond lumen extension140 can be fitted within thedistal opening129 of thesecond lumen128, so that thedistal end144 of thefirst extension140 can be sized to reach into the first iliac of the bifurcation, while thedistal end144 of thesecond extension140 can reach into the second iliac of the bifurcation (seeFIG. 4). In this arrangement, thefirst lumen extension140 oflumen126 serves as a first lumen or ipsilateral lumen of theprosthesis100, and thelumen extension140 of thesecond lumen128 serves as a second lumen or contralateral lumen.
• Themain body component120 may include aproximal sealing stent130 at itsproximal end108, which may extend beyond the prosthetic material112 (seeFIG. 7A). Theproximal stent130 orients themain body prosthesis120 within the lumen and aids in maintaining the position of themain body prosthesis120 in the aorta without obstructing the normal blood flow into the renal arteries. Theproximal sealing stent130 may also serve to limit the length of the prosthesis edge which is exposed to the flow of fluids and may cause scalloping. Theproximal sealing stent130 may be a self-expanding zigzag or diamond shaped stent, for example, and is desirably sewn inside theprosthesis material112, although the stent may be outside, or may be wrapped between two layers ofprosthesis material112, for example.
• Typically, this region of the aorta (proximal neck of the aneurysm just below the renal arteries) is also one area where one ormore fasteners402 may be introduced by afastener device400 to anchor theprosthesis100 in place (seeFIG. 4). However, it should be noted that other areas throughout themain body120 andlumen extensions140 can also be fastened in place. It is desirable that this region of themain body component120 be sized and configured for the receipt and retention of fasteners, e.g., the size and spacing of diamond or zigzag stent patterns to specially accommodate the placement of fasteners; and/or the use of woven fibers with an “X-pattern” or a “sinusoidal pattern” to specially accommodate placement of fasteners; and/or to fold over theprosthetic material112 to form multiple layers, to reinforce the prosthesis in the region wherefasteners402 are placed; and/or the use of denser weave patters or stronger fibers from, e.g., Kevlar™ material or Vectran™ material or metallic wire woven alone or interwoven with typical polyester fibers in the region were fasteners are placed. It may also be desirable to fluoroscopically indicate this region, of the prosthesis withradiopaque markers132 on theprosthetic material112 or proximal sealingstents130 to aid in positioning the fastening devices.
• Additional stents may be utilized throughout themain body component120. Desirably, a minimal number of stents would be utilized within themain body component120.
• Themultiple lumens126 and128 in themain body component120 may typically be supported with distal stent rings134 sewn or otherwise attached to the inside or outside of theprosthetic material112. Theproximal apices136 of the stent rings134 desirably are angled or curved inwardly (seeFIG. 7B). The inward angle provides a retentive feature when thelumen extension140 is positioned within a first or second lumen (seeFIG. 10B). Alternative retentive features may also be used, such as hooks, barbs, loops of fabric or loops/folds of graft material or pockets in graft material, for example. Ideally, the distal stent rings134 in onelumen126 are staggered axially in position with the stent rings134 in theother lumen128, so that they do not overlap each other when themain body component120 is radially compressed prior to deployment.
• Rotational orientation of themain body component120 within the vessel lumen or hollow body organ is accomplished with additionalradiopaque markers137 and138 attached to themain body prosthesis120 for visualization under fluoroscopy. Typically, these markers may be attached to theprosthetic material112. Still, themarkers137 and138 may be attached to the proximal sealingstent130 or distal stent rings134 instead of or in addition to theprosthetic material112 to help fluoroscopically determine the location of all prosthesis openings. The radiopaque markers typically are in the form of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, tantalum, or gold for example.
• Desirably, one ormore markers137,138, are longer than the other, and are attached on opposite sides of themain body component120 with thelonger markers137 aligned on the side with thefirst lumen126 and theshorter markers138 aligned on the side with thesecond lumen128, for example. In an alternative embodiment the markers could be aligned with the septum. Themarkers137 and138 enable the clinician to determine the desired rotational orientation of themain body prosthesis120 in the delivery system so that, upon deployment, the firstdistal opening127 and the seconddistal opening128 are aligned with the desired iliac arteries. Theproximal markers132 may also be included to enable the clinician to determine the position of theproximal end108 of themain body component120 in relation to the fixation point of the aorta. Additionally,distal markers139 may be included to aid in the location of thedistal openings127,129, and the insertion of thelumen extension140. Insertion depth marker(s)125 may be attached near theseptum124, or may be attached to the septum, or may be attached to theprosthesis material112, for example, to indicate the location of and insertion depth for thelumen extension140.
• As previously described, the main body120 (and the lumen extension140) desirably utilizes aprosthetic material112. Thematerial112 of themain body120 may carry individual self-expanding, zigzag or diamond type stent rings, for example. The stent rings need not be attached to one another throughout themain body prosthesis120. However, it may be desirable in certain locations within theprosthesis structure120 to have attachments between the individual stent rings to provide stability and/or additional radial support.
• As previously stated, theseptum124 is formed by sewing, heat bonding, stitching, or weaving opposing surfaces (i.e., the front and back) of theprosthetic material112 of themain body component120 together. In the region of theseptum124, the stent rings134 extend from theseptum124 about the formed lumen, but do not enter or otherwise interrupt theseptum124 itself. Theseptum124 is continuous and is formed separate from the supporting structure of stent rings134.
• The individual distal stent rings134 allow for longitudinalmain body prosthesis120 compliance while maintaining radial support of the prosthesis lumens. This technical feature allows the prosthesis to more readily accommodate changes in vessel/aneurysm morphology.
• The stents can be made, e.g., from Nitinol®. Still, other materials, manufacturing methods and designs can be used. Each of the stents may be sewn ontoprosthetic material112. In certain locations it is desired to have the stents attached to the outer diameter of theprosthetic material112. Still, it is also contemplated that the stents could be attached to the inner diameter of theprosthetic material112.
• In the illustrated embodiment, theprosthetic material112 is woven polyester, and the attachment of the stents is made with polyester suture. However, it is also contemplated that other attachment means could be utilized to secure the stents to theprosthetic material112. These means include bonding; capturing the stents between two layers ofprosthetic material112; and incorporating the stents directly into the wovenprosthetic material112.
• As seen inFIG. 9A, thelumen extension140 has at least onespiral stent146 positioned along at least a portion of the length of the extension and attached to the outside ofprosthetic material112 to provide stability and/or additional radial support. However, as in themain body component120, it is contemplated that thestent146 could also be placed on the inside of theprosthetic material112, or thespiral stent146 could be captured between two layers of prosthetic material (not shown). Theprosthetic layer112 could be a continuous tube or non-tubular. Theprosthetic material112 could cover theentire lumen extension140 or theprosthetic material112 could cover only a portion of the lumen extension. Furthermore, as previously discussed, thespiral stent146 need not be one continuous stent along the length of the extension. The addition of thespiral stent146 to thelumen extension140 aids in the deployment of the lumen extension and allows for longitudinal compliance while maintaining radial support of the lumen within thelumen extension140. Typically,radiopaque extension markers148 are used on each end of theextension140 to aid in the visualization of the placement of thelumen extension140 within the lumen of the firstdistal opening127 and the seconddistal opening129 of themain body component120.
• As shown inFIGS. 9A through 9D, the engaging stent orstents150 in thelumen extension140 can be sized, configured, and arranged to engage the stent rings134 in thefirst lumen126 and thesecond lumen128 of themain body120. Thedistal apices147 of at least oneengaging stent150 are angled outwardly to engage the matingdistal stent134 on the main body component120 (seen particularly inFIGS. 9B and 9D). This engagement prevents thelumen extension140 from moving or migrating axially in relation to thefirst lumen126 and thesecond lumen128 after thelumen extension140 has been deployed. In an alternative embodiment shown inFIGS. 10A through 10D, thespiral stents146, which are attached to the outside of thelumen extension140, may engage with thedistal stents134 of themain body120 without being angled outwardly. In either of these embodiments, additional features may be included with themain body120 or thelumen extensions140 to help prevent thelumen extension140 from moving or migrating axially in relation to themain body120, such as hooks, barbs, loops of fabric or loops/folds of graft material, or pockets in graft material, for example.
• During use (seeFIG. 58), thedeployment catheter200 is navigated over theguide wire30 through an iliac to the desired location within the aorta near the renal arteries. Thecatheter200 carries themain body component120 of themulti-lumen prosthesis system100 in a radially reduced configuration. At the targeted site, the retainingjacket210 is retracted which allows thedistal stent134 of thesecond lumen128 to radially expand into the position shown inFIG. 60. Thedistal stent134 of thefirst lumen126 and theproximal stent130 are not allowed to expand until releasing means have been activated.
• AsFIGS. 69 and 70 show, thefirst lumen extension140 is carried in a radially compressed condition by an over-the-wire extension catheter350 coming from the contralateral iliac, for example. Thecatheter350 deploys thefirst lumen extension140, such that theproximal end142 of thelumen extension140 is telescopically received within thesecond lumen128 of themain body component120 and thedistal end144 extends into the contralateral iliac, asFIG. 71 shows. Thesecond lumen extension140 is then carried in a radially compressed condition by theextension catheter350 coming from the ipsilateral iliac, for example. Theextension catheter350 deploys thesecond lumen extension140, such that theproximal end142 of thelumen extension140 is telescopically received within thefirst lumen126 of themain body component120 and thedistal end144 extends into the ipsilateral iliac, asFIG. 77 shows. Only when eachlumen extension140 is telescopically received within thefirst lumen126 andsecond lumen128 of themain body component120, abifurcated prosthesis100 is formed with divergent lumens; as seen inFIG. 78.
IV. IMPLANTATION APPARATUS
• A. Prosthesis Deployment Catheter
• FIG. 11 shows aprosthesis deployment catheter200 having features of the invention. The purpose of thecatheter200 is to (i) contain and/or restrain themain body prosthesis120 prior to its deployment (seeFIG. 14A), (ii) deliver themain body prosthesis120 through the vasculature to a desired location within the body, e.g., a hollow body organ or a blood vessel (seeFIG. 1), and (iii) controllably deploy themain body prosthesis120 in the desired location (seeFIGS. 2 and 3), including maintaining a stable position of themain body prosthesis120 in a partially deployed condition while the main body prosthesis is fastened to the vessel wall. In the illustrated embodiment, theproximal end202 of thecatheter200 is shown positioned over aguide wire30 in a body lumen (seeFIG. 1). Thecatheter200 carries themain body prosthesis120 in a radially reduced configuration to the targeted site. At the targeted site, thecatheter200 releases the radially reducedprosthesis120, which expands radially (seeFIGS. 2 and 3). After partial or complete expansion or deployment of themain body prosthesis120, one ormore fasteners402 are desirably introduced by afastener device400 to anchor themain body prosthesis120 in place. Thefasteners402 may also serve to provide apposition of theprosthesis material112 to the hollow body organ or vessel wall and to seal and/or repair a fluid leak. Further details of the fastener device and fastener can be found in section three (3) below.
• As previously described, theprosthesis100 can be sized and configured to be either straight or bifurcated form.FIG. 4 depicts a completely deployedbifurcated prosthesis100.FIG. 5 depicts a completely deployedstraight prosthesis50.
• For the purposes of illustration,FIG. 1 shows the targeted site as being within an abdominal aortic aneurysm. Of course, the targeted site can be elsewhere in the body.
• As shown inFIGS. 11 through 14B, thecatheter200 comprises aninner assembly208, anouter jacket210, and ahandle assembly212. These components will now be individually described in greater detail.
• 1. The Inner Assembly
• In the illustrated embodiment (seeFIGS. 12 through 14B), theinner assembly208 comprises acentral shaft216, which functions as a carrier for themain body prosthesis120, proximal and distal retaining means218,220, and acatheter tip component222. The proximal retaining means218 desirably comprises a first proximal retaining means224 and a second proximal retaining means226. The first proximal retaining means224 desirably retains at least a portion of themain body prosthesis120 in a radially compressed, and/or partially radially expanded condition prior to deployment and prior to fastening themain body prosthesis120 to the vessel wall. The second proximal retaining means226 desirably functions to stabilize the deployed proximal sealingstent130 by preventing longitudinal and to a limited extent rotational movement. Each of the first and second proximal retaining means also desirably include a co-acting releasing means ormechanism228,230 for maintaining the first or second proximal retaining means224,226 in a desired relationship with themain body prosthesis120 prior to activation. The distal retaining means ormechanism220 also desirably includes a releasing means ormechanism232 for activating/releasing the distal retaining means ormechanism220. The releasing means may comprise a wide variety of devices, such as wire or wires, sutures, magnetics, or fluids, and may include sliding, pulling or pushing, for example.
• a. The Central Shaft
• In the embodiment shown inFIGS. 13 and 14A, thecentral shaft216 and the proximal and distal retaining means218,220 are located within the confines of theouter jacket210. In this respect, theouter jacket210 functions as an enclosure for themain body prosthesis120 on the carrier (seeFIG. 14A). In this arrangement, thecatheter tip component222 is attached to the proximal end of thecentral shaft216, and the proximal end of theouter jacket210 terminates adjacent thecatheter tip component222. Thus, thecatheter tip component222 extends outward beyond theouter jacket210. Thecentral shaft216, the proximal and distal releasing means228,230,232, and theouter jacket210 may be coupled to thehandle assembly212 at the proximal end of the catheter handle assembly212 (seeFIG. 11). As can be seen inFIG. 14A, themain body prosthesis120 is contained in acavity234 defined between thecentral shaft216 and theouter jacket210 in the proximal section of thedeployment catheter200.
• Thecentral shaft216 extends from thehandle assembly212 to thecatheter tip component222. Thecentral shaft216 may be made, e.g., from stainless steel or other suitable medical materials including other metals or polymers. Thecentral shaft216 comprises at least one lumen, desirably more than one lumen, and more desirably four lumens.
• One lumen may be described as the central lumen236 (seeFIG. 15), with an inner diameter between 0.010 and 0.120 inches, desirably between 0.020 and 0.060 inches and most desirably between 0.030 and 0.050 inches. As described, thecentral lumen236 allows for the insertion of theguide wire30 up to 0.038″ diameter. Thecatheter tip component222 also desirably has at least one lumen238 (seeFIG. 16) configured to align with at least one lumen within thecentral shaft216. Thislumen238 allows for the insertion of theguide wire30 through thecentral shaft216 and through thecatheter tip component222. Typically thislumen238 will have an inner diameter between 0.010 and 0.120 inches, desirably between 0.020 and 0.060 inches and most desirably between 0.030 and 0.050 inches.
• b. Catheter Tip
• Desirably, thecatheter tip component222 is flexible and has a long, taperedproximal end240 and a shorter, tapereddistal end242. The maximum diameter of thecatheter tip component222 is approximately the same as the outside diameter of the proximal end of theouter jacket210. Theproximal end240 of thecatheter tip component222 provides a smooth tapered transition from thelumen238 containing theguide wire30 to the proximal edge of theouter jacket210. This feature aids in catheter insertion and navigation through tortuous anatomy over theguide wire30. The tapered section on thedistal end242 of thecatheter tip component222 prevents thecatheter tip component222 from inadvertently engaging themain body prosthesis120, portions of the surrounding anatomy, or an introducer sheath or the like during removal of thedeployment catheter200 from the body.
• 2. Proximal Retaining Means
• a. First Proximal Retaining Means
• As can be seen inFIGS. 17 through 19, in the illustrated embodiment, the first proximal retaining means224 comprises at least one suture, or sutures,252 and/or equivalent structures, which are coupled to theprosthetic material112, or one ormore stents130 on themain body prosthesis120. Thesuture252 is, in turn, looped around the releasing means228, e.g., arelease wire250, when the release,wire250 is in its proximal-most position, asFIGS. 17 and 18A shows. Distal retraction of thewire250 withdraws thewire250 from thesuture loop252, and allows theproximal end108 of themain body prosthesis120 to radially expand, asFIG. 19 shows. In an alternative embodiment, thesuture252 may comprise more than one suture, i.e., two or more suture loops.FIG. 18B shows the path of twosuture loops252 looped around therelease wire250.
• Belt loops or the like may be provided on themain body prosthesis120 and/orlumen extensions140 to guide and support the suture loop(s) along the path of the suture loop (seeFIGS. 17 and 46B for example). The belt loops can be spaced at desired circumferential intervals, such as every ninety degrees, for example.
• In the illustrated embodiment, one end of thesuture loop252 is coupled to theprosthetic material112 or one ormore stents130 at or near theproximal end108 of themain body prosthesis120. Thesuture loop252 is then looped around themain body prosthesis120 and the releasing means228 in a predetermined pattern, as shown inFIG. 18A, in order to compress and retain theproximal end108 of theprosthesis120. The free end of thesuture loop252 is then coupled to theprosthetic material112 or one ormore stents130 at or near theproximal end108 of themain body prosthesis120.FIG. 18B shows twoseparate loops252 looped around themain body prosthesis120 and therelease wire250. It should be appreciated, however, thatsuture loop252 could be coupled to stents elsewhere in themain body prosthesis120, and/or the other components of themain body prosthesis120 as well.
• Thesuture loop252 and releasingmeans228, e.g.,release wire250, of the embodiment just described retains theprosthesis120 in a desired relationship to the central shaft (seeFIG. 17). Thesuture loop252 and the releasing means228 help to keep themain body prosthesis120 from moving distally as theouter jacket210 is retracted. Thesuture loop252 also keeps the stent orstents130 that are retained by thesuture loop252 in a radially compressed condition as theouter jacket210 is retracted. Thesuture loop252 and releasingmeans228 prevent theproximal end108 of themain body prosthesis120 from self-expanding until the releasing means228 has been withdrawn. In the illustrated embodiment, the withdrawal of the releasing means228 is accomplished by operating a control knob to move the releasing means228 distally, withdrawing the releasing means228 away from thesuture loop252. Once the releasing means228 is withdrawn, the restrained components of themain body prosthesis120 are free to self expand, asFIG. 19 shows.
• As can be seen inFIGS. 20 and 21, the first proximal-releasingmeans228 comprises a firstproximal release hub244 positioned over thecentral shaft216, and arelease wire250. The firstproximal release hub244 may include a small hole orlumen246 in the proximal end of thehub244 that is in fluid communication with a firstproximal release lumen248 within thecentral shaft216. Eachlumen246,248 desirably includes a diameter sufficiently large to accommodate the firstproximal release wire250 extending from thehandle assembly212 to beyond the firstproximal release hub244. It is to be appreciated that therelease wire250 may extend external theshaft216 as well.
• The first proximal retaining means224 holds themain body prosthesis120 in a desired configuration prior to deployment (seeFIGS. 17 and 18A) and the first proximal releasing means228 selectively releases themain body prosthesis120 for the first stage of deployment (seeFIG. 19). In the illustrated embodiment, the distal end of the firstproximal release wire250 is connected to an actuator or control button or knob in thehandle assembly212, as will be described further below.
• Themain body prosthesis120 is retained by at least the first proximal retaining means224 along thecentral shaft216 in thecavity234, which extends between thedistal end242 of thecatheter tip component222 and the proximal end of a spacer206 (as best seen inFIG. 14A). In the illustrated embodiment, the releasing means228 includes therelease wire250 that may extend through at least a portion of thecentral shaft216. The proximal end of thewire250 passes through thelumen246 of the firstproximal release hub244. The firstproximal release wire250 is thereby kept in a desired relationship within or along thecentral shaft216. The distal end of the firstproximal release wire250 is coupled to the control knob, such that fore and aft movement of the knob moves therelease wire250, respectively, proximally and distally.
• As illustrated and described, the firstproximal releasing means228 is coupled to one restrained component of themain body prosthesis120, i.e.,suture loop252. It should be appreciated, however, that the releasing means228 can be coupled to themain body prosthesis120 at two or more restrained regions, so that withdrawal of the releasing means228 frees the prosthesis at two or more restrained regions. It should also be appreciated that the releasing means228 can comprise more than a single releasing element. For example, multiple, individual releasingwires250 could be coupled to themain body prosthesis120 at different regions, so that release of separate regions of themain body prosthesis120 can be individually controlled.
• b Second Proximal Retaining Means
• Referring back toFIG. 12, the proximal retaining means218 may also incorporate a second retaining means226 which may function in cooperation with, or separate from the first proximal retaining means224. The second proximal retaining means226 may be held in place by the second proximal releasing means230 in a predetermined, spaced relationship with thecentral shaft216.
• Referring now toFIGS. 22 through 27, the second proximal retaining means226 may comprise at least one stabilizingarm256, and/or equivalent structures, and desirably more than one stabilizing arm, such as three stabilizing arms, as shown. The second proximal releasing means226 may comprise a secondproximal release hub266 and a second proximal release wire orwires268.
• The distal ends258 of the stabilizingarms256 are coupled to the secondproximal release hub266. In a pre-deployment configuration, the proximal ends262 of the stabilizingarms256 are arched back generally toward the first proximal release hub244 (seeFIGS. 23 and 24) and are releasably attached to theprosthesis material112 at or near theproximal end108 of the main body prosthesis120 (seeFIGS. 24 and 25). In a post-deployment configuration, as seen inFIG. 26, the stabilizingarms256 extend proximally toward thecatheter tip222.
• The proximal ends262 of the stabilizingarms256 include a stabilizingarm aperture264. In the pre-deployment configuration, the stabilizingarms256 are positioned within theproximal opening122 of themain body prosthesis120 and the secondproximal release wire268 is stitched or otherwise extended through the stabilizingarm aperture264 and through theprosthesis material112, releasably securing the stabilizingarms256 to the main body prosthesis120 (as best seen inFIG. 25). Distal retraction of the second proximal release wire268 (using a second control knob, to be described later) withdraws the secondproximal release wire268 from theprosthesis material112 and releases the stabilizingarms264. Themain body prosthesis120 is now free from the retentive feature of the stabilizingarms256, and the stabilizing arms return to the post-deployment configuration, as shown inFIG. 26. It is to be appreciated that the secondproximal release wire268 may comprise multiple release wires, including one release wire for each stabilizingarm256. The secondproximal release wire268 may comprise a single wire extending through the central shaft, and then divide into multiple wires to individually engage the stabilizing arms, or therelease wire268 may comprise multiple wires extending through thecentral shaft216 to individually engage each stabilizingarm256. In an alternative embodiment, the stabilizingarms256 could be positioned in the reverse orientation on the cathetercentral shaft216. Stabilizing arms of this configuration would be biased open away from thecentral shaft216 and would require a secondary means to retain them in close proximity to thecentral shaft216 in order to be rejacketed before catheter removal.
• In the embodiment shown inFIGS. 24 through 27, the second proximal retaining means226 includes a secondproximal release hub266 positioned over thecentral shaft216. The secondproximal release hub266 may include a small hole orlumen270 in the proximal end of thehub266 that is in fluid communication with the secondproximal release lumen272 within the central shaft (seeFIGS. 24 and 27). Thelumen270 and272 desirably includes a diameter sufficiently large to accommodate at least one secondproximal release wire268 extending from thehandle portion212 to beyond the secondproximal release hub266. It is to be appreciated that therelease wire268 may extend external theshaft216 as well.
• The second proximal retaining means226 holds themain body prosthesis120 in a desired configuration prior to deployment (seeFIGS. 19 and 24) and selectively releases themain body prosthesis120 for the second stage of deployment (seeFIG. 26). In the illustrated embodiment, the distal end of the secondproximal release wire268 is connected to an actuator or control button or knob in thehandle assembly212, as will be discussed further below.
• Themain body prosthesis120 is retained by the second proximal retaining means226 in a spaced apart relationship to the central shaft216 (seeFIG. 24). In the illustrated embodiment, the second proximal releasing means230 includes the secondproximal release wire268 that may extend through at least a portion of thecentral shaft216. The proximal end of therelease wire268 passes through thelumen270 of the secondproximal release hub266. The secondproximal release wire268 is thereby kept in a desired relationship within or along thecentral shaft216. The distal end of the secondproximal release wire268 is coupled to the second control knob, such that fore and aft movement of the second knob moves the secondproximal release wire268, respectively, proximally and distally.
• 3. Distal Retaining Means
• As can be seen inFIGS. 28 through 33, in the illustrated embodiment, the distal retaining means220 comprises at least one suture, or sutures,274 and/or equivalent structures, which are coupled to theprosthetic material112, or one ormore stents134 on themain body prosthesis120. Desirably, thesuture274 is coupled to theprosthesis material112 near thedistal end110 of themain body120, and more desirably near thedistal opening127 of thefirst lumen126. Thesuture274 is, in turn, looped around the releasing means232, e.g., arelease wire282, when therelease wire282 is in its proximal-most position, asFIGS. 28 and 29A show. Distal retraction of thewire282 withdraws thewire282 from thesuture loop274, and allows thedistal end110 of themain body prosthesis120 to radially expand, asFIG. 30 shows. In an alternative embodiment, thesuture274 may comprise more than one suture, i.e., two or more suture loops.FIG. 29B shows the path of twosuture loops252 looped around therelease wire292.
• As described for the first proximal retaining means, belt loops or the like may be provided on themain body prosthesis120 and/orlumen extensions140 to guide and support the suture loop(s) along the path of the suture loop. The belt loops can be spaced at desired circumferential intervals, such as every ninety degrees, for example.
• In the illustrated embodiment, one end of thesuture loop274 is coupled to the prosthetic material-112 or one ormore stents134 at or near thedistal end110 of themain body prosthesis120. Thesuture loop274 is then looped around themain body prosthesis120 and the distal releasing means232 in a predetermined pattern, as shown inFIG. 29A, in order to compress and retain thedistal end110 of themain body prosthesis120. The free end of thesuture loop274 is then coupled to theprosthetic material112 or one ormore stents134 at or near theproximal end110 of themain body prosthesis120.FIG. 29B shows twoseparate loops252 looped around themain body prosthesis120 and therelease wire250. It should be appreciated, however, thatsuture loop274 could be coupled to stents elsewhere in themain body prosthesis120, and/or the other components of themain body prosthesis120 as well.
• Thesuture loop274 and releasingmeans232, e.g.,release wire282, of the embodiment just described retain the distal end of themain body prosthesis120 to the central shaft216 (seeFIG. 28). Thesuture loop274 and the releasing means232 keep themain body prosthesis120 from moving distally as theouter jacket210 is retracted. The releasing means232 also keeps the stent orstents134 that are retained by thesuture loops274 in a radially compressed condition as theouter jacket210 is retracted. Thesuture loop274 and releasingmeans232 prevent thedistal end110 of themain body prosthesis120 from self-expanding until the releasing means232 has been withdrawn. In the illustrated embodiment, the withdrawal of the releasing means232 is accomplished by operating a control knob to move the releasing means232 distally, withdrawing the releasingmeans232 and away from thesuture loop252. Once the releasing means232 is withdrawn, the restrained components of themain body prosthesis120 are free to self expand, asFIG. 30 shows.
• In the embodiment shown inFIGS. 28 through 31, the distal releasing means232 includes adistal release hub276 positioned over thecentral shaft216 and arelease wire282. The distal release hub may include a small hole orlumen278 in the proximal end of the hub that is in fluid communication with adistal release lumen280 within the central shaft216 (seeFIG. 31). Eachlumen278,280 desirably includes a diameter sufficiently large to accommodate adistal release wire282 extending from thehandle assembly212 to beyond the distal release hub. It is to be appreciated that therelease wire282 may extend external to theshaft216 as well.
• The distal retaining means220 holds thedistal end110 of themain body prosthesis120 in a desired configuration prior to deployment of the distal end (seeFIG. 28) and the distal releasing means232 selectively releases thedistal end110 of themain body prosthesis120 for the final stage of deployment (seeFIG. 30). In the illustrated embodiment, the distal end of the distal releasing means232 is connected to an actuator or control button or knob in thehandle assembly212, as will be described further below.
• In the illustrated embodiment, the distal releasing means232 includes thedistal release wire282 that may extend through at least a portion of thecentral shaft216. The proximal end of thewire282 passes through thelumen278 of thedistal release hub276. The proximal end of thedistal release wire282 then may extend back into thecentral shaft216 through the second distal release hole orlumen284 positioned spaced apart from thedistal release hub276. The proximal end of therelease wire282 is thereby kept in a desired relationship within or along thecentral shaft216. The distal end of thedistal release wire282 is coupled to the distal control knob, such that fore and aft movement of the distal control knob moves thedistal release wire282, respectively, distally and proximally.
• As illustrated and described, the distal releasing means232 is coupled to themain body prosthesis120 or a component of the main body prosthesis, i.e.,suture loop274. It should be appreciated, however, that the distal releasing means232 can be coupled to themain body prosthesis120 at two or more restrained regions, so that withdrawal of the distal releasing means232 frees the prosthesis at two or more restrained regions. It should also be appreciated that the distal releasing means232 can comprise more than a single releasing element. For example, multiple, individual releasingwires282 could be coupled to themain body prosthesis120 at different regions, so that release of separate regions of the distal end of themain body prosthesis120 can be individually controlled.
• In an alternative embodiment, the distal retaining means220 may comprise theprosthesis material112. As can be seen inFIG. 32, thedistal release wire282 may be threaded through theprosthesis material112 near thedistal end110 of themain body prosthesis120, e.g., thefirst lumen126. Thedistal release wire282 then desirably extends into the seconddistal lumen284. The proximal end of therelease wire282 is thereby kept in a desired relationship within or along thecentral shaft216 to retain thewire282. In this configuration, the distal stent(s)134 are not radially restrained. As the outer jacket is retracted, thedistal end110 of themain body prosthesis120 is free to radially expand. Thedistal release wire282 serves to maintain the position of thedistal end110 relative to thecatheter shaft216. This feature allows for a greater flow of fluid through the lumens of the main body prosthesis while still maintaining longitudinal or axial control of themain body prosthesis120 during the deployment process. In the illustrated embodiment, the withdrawal of therelease wire282 is accomplished by operating a control knob to move therelease wire282 distally, withdrawing therelease wire282 from theprosthesis material112 and releasing the restrained components of themain body prosthesis120 from thecatheter shaft216, asFIG. 33 shows.
• B. The Outer Jacket
• As previously described, theouter jacket210 serves to restrain thestents130,134 on themain body prosthesis120 from expanding and allows for a controlled deployment of themain body prosthesis120 within the body (seeFIG. 14A). In the illustrated arrangement, theouter jacket210 is coupled to an actuator orknob302 on thehandle assembly212, as will be described in greater detail below.
• AsFIG. 14A shows, theouter jacket210 extends proximally over thespacer206 andmain body prosthesis120 and terminates adjacent thedistal end242 of thecatheter tip component222. Typically, theouter jacket210 can be made of a polymer tube or similar materials known in the art. In one embodiment, thejacket210 may be free of structural reinforcement. In an alternative embodiment (shown inFIG. 14B), thejacket210 may include structural reinforcement, such as but not limited to, a wire orrod211 positioned longitudinally along a length of the jacket, and/or a wire orrod213 positioned helically around a length of the jacket. The structural reinforcement may also be in the form of a coil(s) or braided wire, for example. The plasticity of the structural reinforcement may be altered to affect the flexibility of thejacket210 depending on a selected application. In addition, the structural reinforcement may extend along the full length of thejacket210, or may be positioned along only a portion or portions of the length of the jacket. The structural reinforcement may be embedded within thejacket210, or may be coupled to the interior or exterior surface of the jacket.
• In the illustrated embodiment, theouter jacket210 is configured to maintain a consistent diameter throughout its entire length (seeFIG. 11). The outer jacket may also be tapered due to a difference in outer diameters of thecatheter tip component222. The diameter of theouter jacket210 is intended to contain themain body prosthesis120, and optionally anextension portion140 or portions of themain body prosthesis120, if present. The outer diameter continues distally to thehandle assembly212. The relatively small size of the outer diameter of theouter jacket210 also allows for better blood circulation passed thedeployment catheter200.
• Returning toFIG. 14A, thespacer206 provides support for theouter jacket210 and, by occupying space within theouter jacket210, reduces the amount of air entrapped within thedeployment catheter200. The proximal end of thespacer206 desirably terminates adjacent thedistal end110 of themain body prosthesis120. In this arrangement, thecavity234 containing themain body prosthesis120 extends from thedistal end242 of thecatheter tip component222 to the proximal end of thespacer206. AsFIG. 14A shows, thespacer206 is positioned over thecentral shaft216 and the distal end of thespacer206 is connected to thehandle assembly212. Typically, thespacer206 can have an outer diameter slightly less than the inner diameter of theouter jacket210. Thespacer206 can comprise a single lumen or an array of multiple lumens for passage of the various components within thespacer206.
• C. Handle Assembly
• Thehandle assembly212 provides the operator with longitudinal or axial control and rotational control of thedeployment catheter200 within the body and provides access to the actuator(s) or control means for deploying themain body prosthesis120.
• Referring toFIGS. 34 through 36, thehandle assembly212 comprises a handle,body290, a jacket retraction means292, which is connected to the distal end of theouter jacket210, a slidingknob294 which may also be connected to the distal end of theouter jacket210, and at least one actuator or knob which is attached to the distal end of the proximal and distal releasing means. Desirably, thehandle212 comprises a separate knob for each of the first proximal releasing means228, the second proximal releasing means230, and the distal releasingmeans232.
• In the illustrated embodiment, thecentral shaft216 is captured within thehandle212 and has a guidewire receiving luer296 and aninfusion valve297 coupled to its distal end, which is located at the distal end of the handle assembly212 (seeFIGS. 37 and 38). This feature prevents the position of themain body prosthesis120 from moving relative to thehandle body212 while theouter jacket210 is retracted, and allows for irrigation or flushing of thecatheter shaft216, such as with a saline solution.
• To withdraw theouter jacket210 from thecatheter tip222 and expose the proximal end of the main body prosthesis120 (seeFIGS. 37 through 40), the jacket retraction means292 is used. The jacket retraction means292 may include a variety of different mechanisms to selectively control the retraction of thejacket210 from thecatheter tip222. In the illustrated embodiment, the jacket retraction means292 comprises a rack and pinion type control mechanism to provide a mechanical advantage sufficient to withdraw thejacket210 from thecatheter tip222. Apinion298 is carried by agear axle300, and is rotated by a startingknob302 positioned on at least one end of thegear axle300, as best seen inFIG. 41. A single starting knob may be present, or as shown inFIGS. 39 and 40, two co-acting starting knobs302 may be available for the clinician, one positioned on afirst side304 and one positioned on asecond side306 of thehandle212. Acomplimentary rack308 is carried by ajacket slide310. Thepinion298 controls distal movement of therack308 along thejacket slide310 between a first (jacket extended)position312, shown inFIG. 39, and a second (jacket retracted)position314, shown inFIG. 40.
• Thejacket slide310 is coupled to thejacket210 and is temporarily coupled to thegear rack308 via a spring loaded connectingpin316. The connectingpin316 disengages thejacket slide310 at a predetermined position in thehandle body290 by springing or otherwise retracting into arecess318 in thehandle body290. When the connectingpin316 disengages, thejacket slide310 is free to travel in both a proximal and distal direction without re-engaging therack308. Therack308 desirably remains in this retractedposition314. A ratchet pawl, such as a spring backedratchet pawl320 may be coupled to therack308 to allow the rack to travel in a distal direction, but restrict proximal travel of therack308. Ratchetteeth322 may be provided in thehandle body290 to engage theratchet pawl320.
• Once thejacket slide310 has traveled distally and therack308 has been disengaged, thejacket sliding knob294 may then be used to continue the retraction of thejacket210 from themain body prosthesis120. Thejacket slide310 is moved distally until theouter jacket210 is free of the main body prosthesis120 (seeFIG. 60, for example). The portion or portions of themain body prosthesis120 that are not coupled to the proximal and distal retaining means218,220, are free to self-expand, asFIG. 60 shows. However, the portions of themain body prosthesis120 that are coupled to the proximal and distal retaining means218,220, are still restrained from self-expansion, despite withdrawal of theouter jacket210, asFIG. 60 also shows. The stent structure of themain body prosthesis120 is thereby kept restrained in a close relationship against thecentral shaft216 while theouter jacket210 is retracted. The proximal and distal retaining means218,220 prevents themain body prosthesis120 from moving relative to thecentral shaft216 during retraction of theouter jacket210, which potentially minimizes blood flow through themain body prosthesis120 during the deployment process. Furthermore, as described, themain body prosthesis120 is not “pushed out” of the catheter. Themain body prosthesis120 therefore need not have longitudinal stiffness or a stent structure with a “spine”.
• To employ the first proximal retaining means224, the first proximal sliding knob322 (seeFIG. 34) is moved distally until the proximal end of the firstproximal releasing means228 is withdrawn from the first proximal retaining means224, as previously described. In the illustrated embodiment, the firstproximal release wire250 is positioned within the loops of thesuture loop252, as seen inFIGS. 17 and 18A. As the firstproximal release wire250 is withdrawn from thesuture loop252, thesuture loop252 releases its retentive feature, yet may remain coupled to theprosthesis material112. Theproximal end108 of themain body prosthesis120 is thereby free to self-expand to its first stage deployment configuration, asFIG. 19 shows.
• The same process is repeated for the second proximal retaining means226 and the distal retaining means220. To employ the second proximal retaining means226, the second proximal sliding knob324 (seeFIG. 35) is moved distally until the proximal end of the second proximal releasing means230 is withdrawn from the second proximal retaining means226, as previously described. Theproximal end108 of themain body prosthesis120 is thereby finally released from thecatheter shaft216, asFIG. 26 shows. To employ the distal retaining means220, the distal sliding knob326 (seeFIG. 35) is moved distally until the proximal end of the distal releasing means232 is withdrawn from the distal retaining means220. Thedistal end110 of themain body prosthesis120 is thereby free to self-expand to its final deployment configuration, asFIG. 30 shows. Each of these steps will be described in greater detail in section V. It is to be appreciated that the sliding buttons or knobs may all be positioned on thefirst side304 of the handle, or all may be positioned on thesecond side306 of the handle, or may be positioned with one or more on thefirst side304 and one or more on thesecond side306, as shown. It should also be appreciated that theknobs322,324,326, can comprise separate components that are not part of thehandle assembly212, i.e., on theouter jacket210.
• The proximal and distal retaining means218,220, desirably cooperate with arelease system328 positioned within the handle housing290 (seeFIGS. 37 and 38). Each slidingknob322,324;326, is coupled to arelease slide330,332,334, respectively, positioned within atrack336,338,340, respectively, in or on the release system328 (seeFIGS. 41 through 43). Each release slide is coupled to the distal end of the releasing means, such as a release wire. It is to be appreciated that therelease system328 may also include an interlock system, such as a mechanical linkage for controlling the order by which the slides may be moved. In addition, an interlock system could also include a mechanical linkage to thejacket retraction slide310. This feature would prevent the activation of the release slides until the jacket had been retracted to a predetermined position. It is also to be appreciated that the sliding knobs may include a symbol to indicate to the clinician an appropriate order of deployment.
• As described, themain body prosthesis120 is not released immediately from proximal end to distal end as thejacket210 is withdrawn. The proximal and distal stent orstents130,134, are released in a secondary operation, which follows the withdrawal of theouter jacket210. Placement of theprosthesis extensions140 can therefore comprise a next step in the deployment process.
• 1. Lumen Extension Deployment Catheter
• After the main body of theprosthesis120 has been partially or completely deployed, alumen extension140, or lumen extensions, are next to be implanted. Anextension deployment catheter350 is shown inFIG. 44. It is to be appreciated that theextension deployment catheter350 may incorporate all the features disclosed in the description of thedeployment catheter200. The extension catheter is used for delivery and deployment of thelumen extensions140 to the targeted site.
• In the illustrated embodiment, theextension catheter350 carries thelumen extension140 in a radially reduced configuration to the targeted site. At the targeted site, theextension catheter350 releases the radially reducedlumen extension140, which expands radially, and is coupled to a lumen of themain body prosthesis120, as will be described further in section V.
• As shown inFIGS. 44 through 45B, theextension catheter350 comprises aninner assembly358, anouter jacket360, and ahandle assembly362. These components will now be individually described in greater detail.
• a. The Inner Assembly
• In the illustrated embodiment (seeFIG. 45A), theinner assembly358 comprises acentral shaft364, which functions as a carrier for thelumen extension140, proximal retaining means366, and an extensioncatheter tip component368. The proximal retaining means366 desirably retains at least a portion of thelumen extension140 in a radially compressed or partially radially expanded condition prior to deployment and prior to coupling to themain body prosthesis120. The proximal retaining means366 also desirably includes a co-acting releasing means ormechanism370 for maintaining the proximal retaining means366 in a desired relationship with thelumen extension140 prior to activation.
• In an alternative embodiment (seeFIG. 45B), the inner assembly may also include distal retaining means367. The distal retaining means367 desirably retains at least the distal portion of thelumen extension140 in a radially compressed or partially radially expanded condition prior to deployment and prior to coupling to themain body prosthesis120. The distal retaining means367 also desirably includes a co-acting releasing means ormechanism371 for maintaining the distal retaining means367 in a desired relationship with thelumen extension140 prior to activation.
• b. The Central Shaft
• In the embodiments shown inFIGS. 45A and 45B, thecentral shaft364 and the proximal and distal retaining means366,367 are located within the confines of theouter jacket360. In this respect, theouter jacket360 functions as an enclosure or jacket for thelumen extension140 on the shaft364 (seeFIGS. 46A and B). In this arrangement, thecatheter tip component368 is attached to the proximal end of thecentral shaft364, and the proximal end of theouter jacket360 terminates adjacent thecatheter tip component368. Thus, the extensioncatheter tip component368 extends outward beyond theouter jacket360. Thecentral shaft364, the proximal releasing means366, the distal releasing means367 (shown inFIG. 45B), and theouter jacket360 are coupled to thehandle assembly362 at the proximal end of the catheter handle assembly362 (seeFIG. 44). As can be seen inFIGS. 46A and 46B, thelumen extension140 is contained in acavity372 defined between thecentral shaft364 and theouter jacket360 in the proximal section of theextension catheter350.
• Thecentral shaft364 extends from thehandle assembly362 to thecatheter tip component368. Thecentral shaft364 may be made, e.g., from stainless steel or other suitable medical materials including other metals or polymers. Thecentral shaft364 comprises at least one lumen, and may comprise more than one lumen.
• One lumen may be described as the central lumen374 (seeFIGS. 47A and 47B), with an inner diameter between 0.010 and 0.120 inches, desirably between 0.020 and 0.060 inches and most desirably between 0.030 and 0.050 inches. As described, thecentral lumen374 allows for the insertion of a guide wire, i.e., thefirst guide wire30 or thesecond guide wire40, up to 0.038″ diameter, for example. Thecatheter tip component368, having the same features as described for thecatheter tip222 of thedeployment catheter200, also desirably has at least one lumen376 (seeFIG. 45A) configured to align with at least one lumen within thecentral shaft364. Thislumen376 allows for the insertion of the guide wire through thecentral shaft364 and through the extensioncatheter tip component368. Typically thislumen376 will have an inner diameter between 0.010 and 0.120 inches, desirably between 0.020 and 0.060 inches and most desirably between 0.030 and 0.050 inches.
• c. Proximal Retaining Means
• The proximal retaining means366 and the proximal releasing means370 may function in the same or similar fashion as the retaining means224,226, and the releasing means228,230 embodied in thedeployment catheter200, as previously shown and described. As can be seen inFIGS. 46A and 48A, in the illustrated embodiment, the proximal retaining means366 comprises at least one suture, or sutures,378 and/or equivalent structures, which are coupled to the lumenextension prosthetic material112, or to one ormore stents150 on thelumen extension140. Thesuture378 is, in turn, looped around the proximal releasing means370, e.g., arelease wire380, when therelease wire380 is in its proximal-most position, asFIGS. 46A and 48A show. Distal retraction of thewire380 positioned within a releasing wire lumen381 (seeFIGS. 45A and 47A) withdraws thewire380 from thesuture loop378, and allows theproximal end142 of thelumen extension140 to radially expand, as can be seen inFIGS. 70 and 71. In an alternative embodiment, thesuture378 may comprise more than one suture, i.e., two or more suture loops.FIG. 48C shows the path of twosuture loops378 looped around therelease wire380.
• As described for themain body prosthesis120, belt loops or the like may be provided on thelumen extensions140 as well to guide and support the suture loop(s) along the path of the suture loop. The belt loops can be spaced at desired circumferential intervals, such as every ninety degrees, for example.
• As can be seen inFIG. 45A, the proximal releasingmeans370 comprises aproximal release hub397 positioned over thecentral shaft364, and therelease wire380. Theproximal release hub397 may include a small hole orlumen398 in the proximal end of thehub397 that is in fluid communication with the proximal releasingwire lumen381 within thecentral shaft364. Eachlumen381,398 desirably include a diameter sufficiently large to accommodate therelease wire380 extending from thehandle assembly362 to beyond therelease hub397. It is to be appreciated that therelease wire380 may extend external theshaft364 as well.
• d. Distal Retaining Means
• In an alternative embodiment, the distal retaining means367 and the distal releasing means371 may function in the same or similar fashion as the retaining means220, and the releasing means232 embodied in thedeployment catheter200, as previously shown and described. As can be seen inFIGS. 46B and 48B, the distal retaining means367 comprises at least one suture, or sutures,379 and/or equivalent structures, which are coupled to the lumenextension prosthetic material112, or to one ormore stents150 on thelumen extension140. Thesuture379 is, in turn, looped around the distal releasing means371, e.g., arelease wire383, when therelease wire383 is in its proximal-most position, asFIGS. 46B and 48B show. Distal retraction of thewire383 positioned within a releasing wire lumen385 (seeFIGS.45B47B) withdraws thewire383 from thesuture loop379, and allows thedistal end144 of thelumen extension140 to radially expand. As described for the proximal retaining means366, thesuture379 may also comprise more than one suture, i.e., two or more suture loops.FIG. 48C shows the path of twosuture loops378 looped around therelease wire380. This path may also be used forsuture loops379 looped around therelease wire383.
• As can be seen inFIG. 45B, the distal releasing means371 comprises adistal release hub399 positioned over thecentral shaft364, and therelease wire383. Thedistal release hub399 may include a small hole or lumen395 in the proximal end of thehub399 that is in fluid communication with the distal releasingwire lumen385 within thecentral shaft364. Eachlumen385,395 desirably include a diameter sufficiently large to accommodate therelease wire383 extending from thehandle assembly362 to beyond therelease hub399. It is to be appreciated that therelease wire383 may extend external theshaft364 as well.
• B. The Outer Jacket
• Theouter jacket360 may function in the same or similar fashion as described for theouter jacket210 embodied in thedeployment catheter200. Theouter jacket360 also serves to restrain thestents146 and150 on thelumen extension140 from expanding and allows for a controlled deployment of thelumen extension140 within a lumen of themain body prosthesis120. In the illustrated arrangement, theouter jacket360 is coupled to an actuator orknob382 on thehandle assembly362, as will be described in greater detail below.
• AsFIGS. 46A and 46B show, theouter jacket360 extends proximally over aspacer384 andlumen extension140 and terminates adjacent the distal end of thecatheter tip component368. Typically, theouter jacket360 can be made of a polymer tube or similar materials known in the art. In one embodiment, thejacket360 may be free of structural reinforcement. In an alternative embodiment (shown inFIG. 46C), thejacket360 may include structural reinforcement, such as but not limited to, a wire or rod361 positioned longitudinally along a length of the jacket, and/or a wire or rod363 positioned helically around a length of the jacket. The structural reinforcement may also be in the form of a coil(s) or braided wire, for example. The plasticity of the structural reinforcement may be altered to affect the flexibility of thejacket360 depending on a selected application. In addition, the structural reinforcement may extend along the full length of thejacket360, or may be positioned along only a portion or portions of the length of the jacket. The structural reinforcement may be embedded within thejacket360, or may be coupled to the interior or exterior surface of the jacket.
• If desired, and as shown inFIG. 44B, a stationaryouter jacket365 may be provided that extends from the proximal end of thehandle assembly362. Thejacket360 slides within thestationary jacket365. Thestationary jacket365 provides a seal interface with a hemostatic valve at the access site. Thestationary jacket365 can be made of a suitable medical grade plastic, such as Fluorinated Ethylene Propylene (FEP) as non-limiting example. The stationaryouter jacket365 provides column strength and lubricity to reduce friction during sliding actuation of thejacket360. The stationaryouter jacket365 may also be provided for theprosthesis deployment catheter200 for the same purposes.
• C. Handle Assembly
• Thehandle assembly362 may function in the same or similar fashion as described for thehandle assembly212 embodied in thedeployment catheter200. Thehandle assembly362 provides the operator with longitudinal or axial control and rotational control of theextension deployment catheter350 within the body and provides access to the actuator(s) or control means for deploying thelumen extension140.
• Referring toFIGS. 49 and 50, thehandle assembly362 comprises ahandle body386, a jacket retraction means382, which is connected to the distal end of theouter jacket360, and at least one knob orbutton392 which is attached to the distal end of the proximal releasingmeans370. It is to be appreciated that thehandle assembly362 may also include at least one knob or button393 (seeFIG. 49B) attached to an optional distal releasingmeans371 and the knob or button may function in the same or similar fashion as described below for the proximal releasingmeans370.
• In the illustrated embodiment, thecentral shaft364 is captured within thehandle362 and has a guidewire receiving luer388 and aninfusion valve390 coupled to its distal end, which is located at the distal end of the handle assembly362 (seeFIGS. 50 and 51). This feature prevents the position of thelumen extension140 from moving relative to thehandle body362 while theouter jacket360 is retracted, and allows for irrigation or flushing of thecatheter shaft364, such as with a saline solution.
• To withdraw theouter jacket360 from thecatheter tip368 and expose thelumen extension140, jacket retraction means, such as thejacket retraction knob382 may be used. The jacket retraction means382 may include a variety of different mechanisms to selectively control the retraction of thejacket360 from thecatheter tip368. In the illustrated embodiment, the jacket retraction means comprises two co-acting retraction knobs382 which are available for the clinician, one positioned on each side of thehandle362.
• Thejacket retraction knob382 is used to retract thejacket360 from thelumen extension140. Thejacket retraction knob382 is moved distally until theouter jacket360 is free of the lumen extension140 (seeFIG. 70). The portion or portions of thelumen extension140 that are not coupled to the proximal retaining means366 are free to self-expand, asFIG. 70 shows. However, the portions of thelumen extension140 that are coupled to the proximal retaining means366 are still restrained from self-expansion, despite withdrawal of theouter jacket360. The stent structure of thelumen extension140 is thereby kept restrained in a close relationship against thecentral shaft364 while theouter jacket360 is retracted. The proximal retaining means366 prevents thelumen extension140 from moving relative to thecentral shaft364 during retraction of theouter jacket360, which potentially minimizes blood flow through thelumen extension140 during the deployment process. Furthermore, as described, thelumen extension140 is not “pushed out” of theextension catheter350. Thelumen extension140 therefore need not have longitudinal stiffness or a stent structure with a “spine”.
• To employ the proximal retaining means366, the proximal release sliding knob392 (seeFIGS. 49A and 50) is moved distally until the proximal end of the proximal releasingmeans370 is withdrawn from the proximal retaining means366, as previously described. In the illustrated embodiment, theproximal release wire380 is positioned within the loops of thesuture loop378, as seen inFIGS. 46A and 48A. As theproximal release wire380 is withdrawn from thesuture loop378, thesuture loop378 releases its retentive feature, yet may remain coupled to theprosthesis material112. Theproximal end142 of thelumen extension140 is thereby free to self-expand to its deployment configuration and couple itself within the lumen of themain body prosthesis120, asFIGS. 70 and 71 show. The natural flow of fluid through thenew extension140 provides sufficient force to cause the restraint mechanism of thelumen extension140 to engage the co-acting restraint mechanism of themain body prosthesis120. The lumen extension stent and/or the outwardly extendingapices147 of thelumen extension stent150 engage the mating outwardly extendingapices136 of the main body prosthesis stent134 (seeFIG. 10B). Each of these steps will be described in greater detail in section V. It is to be appreciated that the sliding buttons or knobs may all be positioned on one side of the handle, or all may be positioned on the opposite side of the handle, or may be positioned on both sides, as shown. It should also be appreciated that theknobs382 and392 can comprise separate components that are not part of thehandle assembly362, i.e., on theouter jacket360.
• The proximal retaining means366 desirably cooperate with arelease system394 positioned within thehandle housing386. Proximalrelease sliding knob392 is coupled to arelease slide396 positioned within atrack398 in or on the release system394 (seeFIG. 51). Therelease slide396 is coupled to the distal end of the releasing means370, such as therelease wire380. It is to be appreciated that therelease system394 may also include an interlock system, such as a mechanical linkage for controlling the order by which the slides may be moved. In addition, an interlock system could also include a mechanical linkage to thejacket retraction slide382. This feature would prevent the activation of the release slides until the jacket had been retracted to a predetermined position. It is also to be appreciated that the sliding knobs may include a symbol to indicate to the clinician an appropriate order of deployment.
• As described, thelumen extension140 is not released immediately from proximal end to distal end as thejacket360 is withdrawn. The lumen extension stent orstents146 and150 may be released in a secondary operation, which follows the withdrawal of theouter jacket360. Placement of theprosthesis extensions140 can therefore comprise a final step in the deployment process.
• D. Fastener Device And Fastener
• As previously described, one or more fasteners402 (seeFIG. 52) may be introduced by afastener device400 to anchor theprosthesis100 in place. Typically thefasteners402 will be introduced at the proximal end of themain body prosthesis120; however, it should be appreciated that the fasteners can be introduced in any part of theprosthesis100, including thelumen extensions140, to anchor it in place. In addition, thefasteners402 may also serve to provide apposition of theprosthesis material112 to the hollow body organ or vessel wall. Fasteners may also be used to seal and/or repair leaks or seepage of fluid (e.g., around the proximal stents and/or distal stents of the prosthesis100). One ormore fasteners402 may be introduced into theprosthesis100 at different times or at the same time during the procedure.
• As can be seen inFIGS. 53 and 54, thefastener tool400 desirably comprises ahandle assembly404 including acontrol assembly406 and anindication assembly408. Afastener delivery shaft409, having afastener driver411 at itsproximal end410, is coupled to the proximal end of thehandle assembly404 for delivery of thefastener402. Coupled to the distal end of the handle assembly may be an irrigation port orinfusion valve422.
• Thehandle assembly404 provides the fastening control feature for the clinician. Positioned within thehandle assembly404 is thecontrol assembly406. The control assembly provides motion control, such as a forward and reverse drive feature, for turning or otherwise moving thefastener402 to or from a fastening position. The control assembly desirably includes aforward control button412 and areverse control button414. The forward and reversecontrol buttons412,414 provide the clinician an ergonomic and single finger control of thefastener device400.
• The handle assembly desirably includes anindication assembly408 to provide control information to the clinician. The indication assembly may include indication lights, i.e., LEDs, and/or the ability to produce audible signals (tones) to provide visual and/or audible indication of forward or reverse movement of thefastener402, for example, by way of a variety of tones and/or aforward light416 and areverse light418. Additionally, the indication assembly may include status tones and/or astatus light420 to provide a variety of information back to the clinician. The tones may use a variety of pitches or pulses, for example, and thestatus light420 may use a variety a flash signals and illumination times, for example, to provide these different indications for the clinician, such as error indication, position indication, and timing indication, for example.
• Further details of thefastener device400 andfastener402 can be found in U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, and entitled “Intraluminal Prosthesis Attachment Systems and Methods,” and in U.S. patent application Ser. No. 10/786,465, filed Feb. 29, 2004 and entitled “Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ,” which are both incorporated herein by reference.
• In this embodiment, theproximal coil422 of thefastener402 is formed to produce adiagonal member424, which crosses the diameter of the helical fastener. The distal end of thefastener402 comprises a sharpenedtip426, such as a conical tip or a chiseled tip, for example, to aid in the ease of tissue penetration. Similar helical fasteners are described in U.S. Pat. Nos. 5,964,772; 5,824,008; 5,582,616; and 6,296,656, the full disclosures of which are incorporated herein by reference.
• In an alternative embodiment, thefastener device400 and afastener430 may comprise features allowing thefastener430 to be releasably secured to thefastener driver432. As can be seen inFIGS. 79A and 79B, theproximal coil434 of thehelical fastener430 desirably includes adiagonal member436, which crosses the diameter of thefastener430. Thediagonal member436 may bisect the diameter of thefastener430, or may be offset, forming a “D” shapedproximal coil434, as shown. Thediagonal member436 desirably comes completely across the diameter to prevent thefastener430 from being an open coil and to control the depth of penetration into the tissue. In addition, thediagonal member436 can be attached to a previous coil, as shown, to strengthen the entire structure and provide a retentive shape for afastener driver432. This attachment could be achieved via welding, adhesive or any other suitable means.
• Located at the proximal end of thefastener delivery shaft410 is thefastener driver432. In the illustrated embodiment (seeFIGS. 80 and 81), thefastener driver432 includes afastener carrier438 positioned within a threadedfastener housing439. The threadedfastener housing439 may includetabs437 or other coupling means so as to snap fit or couple to thefastener carrier438 for convenient replacement. The coupling between thedriver432 andcarrier438 can take different forms e.g., magnets, graspers, or other suitable mechanical connection. In the embodiment illustrated inFIGS. 80 and 81, thedriver432 andcarrier438 are integrally connected as a single unit.
• Thecarrier438 is sized and configured to engage a selectedfastener430. Thediagonal member436 serves to define a shape, such as a “D” shape, to engage thecarrier438, which rotates thefastener430 positioned over thecarrier438 to achieve fastening the prosthesis to tissue. Thediagonal member436 also serves as a stop to prevent thehelical fastener430 from penetrating too far into the tissue.
• As can be seen inFIGS. 80 and 81, afastener430 is positioned within thefastener housing439 and over thecarrier438. Thecarrier438 includes arelease latch440. Therelease latch440 may be spring loaded, magnetic, or lever action, for example. Thelatch440 prevents the premature release of thefastener430. Therelease latch440 desirably requires a force to overcome the securing force of the latch. For example, therelease latch440 may be overcome by a pulling force, e.g., thefastener430 is being fastened through the prosthesis and within tissue and the pulling force of the fastener turning or screwing into tissue may overcome the securing force of the release latch. Alternatively, therelease latch440 may be overcome by a magnetic force activated by the clinician by pressing arelease button444 on the handle assembly404 (shown inFIG. 86). In one embodiment shown inFIGS. 82A and 82B, therelease latch440 includes alever arm442 to provide the latching force. As thecarrier438 is rotated to deploy thefastener430, the force of thefastener430 rotating into the tissue may be adequate to overcome the force of therelease latch440. As seen inFIG. 82A, thefastener430 remains fastened to thecarrier438 by way of thefastener release latch440. As seen inFIG. 82B, further rotation of thefastener430 into tissue will cause each coil of the fastener to overcome the force of therelease latch440 and allow thefastener430 to exit off of thecarrier438.
• In an alternative embodiment, therelease latch440 may include arelease spring445, as seen inFIG. 82C. Therelease spring445 is sized and configured to provide a sufficient force to maintain thefastener430 on thecarrier438, and yet allow thefastener430 to overcome the force of therelease spring445 andrelease latch440 as the fastener is being screwed into tissue.
• Thefastener housing439 desirably includes a predetermined amount of internal threads441 (e.g., two or three threads). In this configuration, the threaded portion of thehousing439 may not be continuous throughout the length of the housing. Thethreads441 engage thefastener430 when the fastener is being loaded onto the fastener driver432 (as described below) and also partially drive thehelical fastener430 out of thefastener driver432 and into tissue. Desirably, the threaded portion of the threaded housing terminates a predetermined distance from thehousing tip443. This unthreaded portion of the threadedhousing439 provides an area in which thefastener430 can be rotated but not be driven out of thefastener driver432. This unthreaded feature of thehousing439 allows thefastener430 to pull itself out of thefastener driver432 when rotated by the driver only as long as thefastener430 has been previously engaged with theprosthesis120 and tissue. This feature ensures a more uniform depth of penetration for thefastener430.
• A helical fastener, such as402 and430, for example, may be positioned in afastener cassette446, as seen inFIGS. 83 and 84. Thefastener cassette446 may take on any convenient shape, such as a rectangle or circle, as shown, and may include any convenient number offastener receptacles448, such as six, although any number may be used. Thecassette446 may be used to store and retain fasteners during shipment, and also to provide a convenient means to present thefastener430, for example, to thefastener device400 during a medical procedure.
• As seen inFIGS. 83 and 84, thefastener receptacle448 is sized and configured to allow theproximal end410 and thefastener driver432 of thefastener device400 access to the seatedfastener430. Thefastener430 may be positioned on areceptacle post449, to hold thefastener430 within thereceptacle448. Or alternately, thefastener430 may be held within thereceptacle448 through interference between thefastener430 and thereceptacle448, or by penetrating thefastener tip426 into a material at the base of thereceptacle448. Thereceptacle post449 may include areceptacle post spring447, allowing thereceptacle post449 to retreat into thereceptacle448 as thefastener driver432 is inserted into thereceptacle448 to position thefastener430 on to thecarrier438.
• FIGS. 85 and 86 show an embodiment of afastener430 being positioned within thefastener driver432. As can be seen thefastener driver432 is positioned on top of thereceptacle448 and gently inserted into the receptacle. The force of the insertion allows thefastener430 to overcome the force of therelease latch440 on thecarrier438 and to be positioned over thecarrier438. The fastener driver is then reversed, using thecontrol assembly406 provided on thefastener driver handle404. Theinternal threads441 of the threadedhousing439 draw thefastener430 into thefastener driver432 and into position for deployment.FIG. 86 shows thefastener430 removed from thecassette446 and positioned on thefastener driver432. It is to be appreciated that thecassette446 can be used to hold a variety of fastener shapes and sizes, and is not limited to thefastener430, as described.
• E. Steerable Guide Device
• Asteerable guide device450 may be used to establish an open path through which an operative tool, such as thefastener device400, can be deployed for use.FIGS. 55 and 56 show an embodiment of thesteerable guide device450. The steerable guide device comprises aflexible guide tube452 carried by ahandle454. The handle is sized and configured to be ergonomically held by the clinician to introduce theguide tube452 to the targeted site.
• In order to establish an open path for thefastener device400, thesteerable guide device450 includes aninterior guide passage456 which extends through the interior portion of thehandle454 continuously and into and through theguide tube452. The distal end of thehandle454 may also include aseal457 to restrict the flow of fluids through theguide tube452. During introduction of the guide tube through the vasculature to the targeted site, an obturator ordilator458 having a tip component459 (seeFIG. 57) is positioned within theguide tube452 in order to seal the guide tube and restrict the flow of fluids through theguide tube452, to provide an atraumatic tip for guiding through the vasculature, and to provide aguide wire lumen470.
• The handle assembly desirably includes arotatable steering assembly460 and a flushingport462. Thesteering assembly460 is used to deflect theproximal end464 of theguide tube452 to a bent or deflected configuration, as will be described later. Thesteering assembly460 is rotated in a desired direction, causing theproximal end464 to bend or deflect in a predetermined configuration. Aradiopaque marker466 can be placed on theproximal end region464 of theguide tube452 to allow for fluoroscopic visualization of the orientation of the deflected end region. In the bent or deflected configuration, theproximal end464 can be oriented in a desired relationship with the targeted site.
• Further details of thesteerable guide device450 can be found in U.S. patent application Ser. No. ______, (to be supplied), filed 20 Oct. 2005, and entitled “Devices, Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region,” which is incorporated herein by reference.
V. DETAILED IMPLANTATION METHODS
• The generally described steps of implantation of theprosthesis100 provided in Section II will now be described in greater detail. In the illustrated embodiment, deployment of thebifurcated prosthesis100 may generally be achieved in a twelve step process, for example, and is shown generally inFIGS. 58 through 78. The exemplary embodiment will describe the systems, methods, and uses of the tools for implanting theprosthesis100. It is to be understood that these same or similar systems, methods, and tools may be used to implant other prosthesis configurations in other areas of the body as well. Throughout the implantation process, image guidance may be used and in conjunction with radiopaque markers positioned on theprosthesis100 and deployment tools.
• Access to the vascular system is commonly provided through the use of introducers known in the art. A hemostasis introducer sheath (not shown), for example, may be first positioned in the left femoral artery, providing access for the implantation tools. A second introducer sheath (not shown) may also be positioned in the right femoral artery, providing access for the implantation tools. It is to be understood that alternative access points may also be used. Access at both the left femoral artery and the right femoral artery, for example, allows for multiple implantation tools to be positioned within the vasculature at the same time, allowing the implantation procedure to be efficiently performed.
• A. Position Main Body Prosthesis
• A first step includes positioning themain body prosthesis120 at the desired location. From either the left or right femoral artery, under image guidance, thefirst guide wire30 is advanced into the ipsilateral iliac artery and to the descending aorta. Thedeployment catheter200 is then navigated over thefirst guide wire30 to the desired location within the body, (e.g., aortic aneurysm), for deployment of the main body prosthesis120 (asFIG. 58 shows). A conventional hemostatic valve arrangement may be used at the access site (shown for purposes of illustration inFIG. 44B).
• B. Retract Outer Jacket
• Next, theouter jacket210 is retracted in a distal or caudal direction to expose themain body prosthesis120. By first rotating the startingknob302 on thehandle assembly212, theouter jacket210 is initially retracted from its secure position on thecatheter tip222. After the mechanical advantage provided by the rotation of the startingknob302 has retracted theouter jacket210 away from thecatheter tip222, thejacket sliding knob294 on thehandle212 may be used to further retract thejacket210 and fully expose the main body prosthesis120 (asFIGS. 59 and 60 show). The unrestrained portion or portions of themain body prosthesis120 self-expand, as can be seen inFIG. 60. Optionally, thefirst lumen126 may not be radially restrained, but still restrained in relation to the central shaft216 (seeFIG. 32), so as theouter jacket210 is retracted, thefirst lumen126 may self expand as well, as can be seen inFIG. 61. AsFIGS. 59 through 61 show, both during and after retraction of theouter jacket210, themain body prosthesis120 maintains its position relative to thecentral shaft216 due to the proximal and distal retaining means218,220, coupled to themain body prosthesis120.
• It should be appreciated that the withdrawal of theouter jacket210 and the withdrawal of the proximal and distal releasing means228,230,232, or any combination thereof, can be accomplished in a single step or process or in multiple steps. In this arrangement, a single activation mechanism can be jointly coupled to theouter jacket210 and any or all of the releasing means228,230,232, so that theouter jacket210 and releasingmeans228,230,232, are withdrawn in a single step, or multiple steps.
• C. Release First Proximal Retaining Means
• In the third general step of the deployment process, following the withdrawal of theouter jacket210, the firstproximal sliding knob322 on thehandle assembly212 is moved distally, which causes the proximal end of the first proximal releasing means228, i.e., the firstproximal release wire250, to be withdrawn from the first proximal retaining means224, i.e., thesuture loop252, and allows the restrained stent orstents130, and theproximal end108 of themain body prosthesis120 as a whole, to self-expand radially to the first stage deployment configuration, as seen inFIG. 62. Theproximal end108 of themain body prosthesis120 desirably radially expands either partially or fully toward the internal walls of the vessel or hollow body organ.
• At this point in the deployment process, both the proximal and distal ends of themain body prosthesis120 are being held and controlled, respectively, by the second proximal retaining means226 and the distal retaining means232. This allows the practitioner to adjust the position of themain body prosthesis120 either longitudinally or rotationally before the next stage (fasten proximal end), as well as hold and maintain control of themain body prosthesis120 during the next stage (fasten proximal means). Further, because themain body prosthesis120 can be selectively retained and controlled from both proximal and distal ends during deployment and anchoring, theprosthesis120 itself need not be self-supporting, but can instead be compliant in either or both longitudinal and/or rotational dimensions, and thereby be capable of conforming and accommodating anatomic changes that may occur after implantation (e.g., shrinkage of the aneurysm).
• D. Fasten Proximal End
• The fourth general stage comprises fastening theproximal end108 of themain body prosthesis120 to the internal walls of the vessel or hollow body organ. From the right femoral artery, under image guidance, asecond guide wire40 is advanced using a conventional intravascular approach into the contralateral iliac artery and to the descending aorta. However, other access sites and methods can be utilized. Theguide wire40 desirably extends through the second expandedlumen128 and through theproximal opening122 of the main body prosthesis120 (seeFIG. 63). Next, thesteerable guide device450, with theobturator458 positioned within theinterior guide passage456, is then navigated over thesecond guide wire40 to the desired location with respect to the main body prosthesis120 (seeFIG. 64). Once thesteerable guide device450 is in position, theobturator458 and thesecond guide wire40 are both removed from theinterior guide passage456 and from the body.
• By rotating the steering assembly460 (seeFIG. 55), and still employing fluoroscopy visualization, the clinician deflects theproximal end region464—and rotates thehandle454 to rotate theflexible guide tube452 if necessary—to orient theproximal opening468 of thepassage456 in a desired facing relationship with the site where introduction of afastener402 is desired. An operative tool, such as thefastener device400 is then inserted through theinterior guide passage456 of thesteerable guide device450, and advanced until a fastener, such as thefastener402, is located for deployment in relation to the now-orientedproximal opening468, asFIG. 65 shows. As thefastener device400 is advanced out of thesteerable guide device450 and contacts the wall of themain body prosthesis120, a resultant force is applied to theproximal end464 of thesteerable guide450 which moves in the opposite direction of the fastener deviceproximal end410. The resultant force causes theproximal end464 of thesteerable guide450 to deflect until it contacts the opposite wall of the main body prosthesis within the lumen or hollow body organ. In this way, the force applied to themain body prosthesis120 and vascular wall from theproximal end410 of thefastener device400 is partially resolved through thesteerable guide450 within the vessel or hollow body organ. A representative embodiment of an endovascular device that, in use, applies a helical fastener is described in U.S. patent application Ser. No. 10/786,465, filed Feb. 25, 2004, and entitled “Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ,” which is incorporated herein by reference.
• Thefastener device400 can then be actuated to apply afastener402 to theproximal end108 of themain body prosthesis120 and into the surrounding tissue (seeFIG. 66). If thefastener device400 is a single fire device, i.e., it carries only onefastener402, thefastener device400 is withdrawn through theinterior guide passage456 and anew fastener402 is mounted. SeeFIGS. 85 and 86 for one embodiment of thefastener430 being mounted to thefastener device400. Theproximal end region464 of thesteerable device450 is reoriented in facing relationship with a new fastening site. Thefastener device400 is inserted back through theinterior guide passage456 to apply asecond fastener402 to the new fastening site (seeFIG. 67). This sequence is repeated until a desired number and array offasteners402 are applied to themain body prosthesis120, as can be seen inFIG. 68.
• At this point, thefastener device400 is withdrawn, leaving thesteerable guide device450 in place. Theobturator458 is repositioned within theinterior guide passage456, and thesecond guide wire40 is navigated through theobturator lumen470 to the desired location with respect to themain body prosthesis120. Once thesecond guide wire40 is in position, thesteerable guide device450 and theobturator458 are both removed from theinterior guide passage456 and from the body leaving thesecond guide wire40 in position within the vasculature.
• Throughout this stage of the deployment process, both the proximal and distal ends of themain body prosthesis120 can being held and controlled, respectively, by the second proximal retaining means226 and the distal retaining means232, while fastening occurs.
• E. Position First Lumen. Extension
• In the fifth general stage of the deployment process, following the fastening of theproximal end108 of themain body prosthesis120, theextension deployment catheter350 is used to position alumen extension140 for deployment within a lumen of themain body prosthesis120. From the left or right femoral artery, under image guidance, theextension catheter350 is navigated over thesecond guide wire40 to the desired location, i.e., telescopically positioned partially within thesecond lumen128 of themain body prosthesis120, asFIG. 69 shows. A conventional hemostatic valve arrangement may be used at the access site (shown for purposes of illustration inFIG. 44B).
• F. Retract Extension Catheter Outer Jacket
• Next, the extension catheter'souter jacket360 must be retracted in a distal or caudal direction to expose thelumen extension140. Thejacket sliding knob382 on the extension catheter handle362 is urged in a distal direction to retract thejacket360 and fully expose thelumen extension140. The unrestrained portion or portions of thelumen extension140 self-expand (seeFIG. 70). Both during and after retraction of theouter jacket360, thelumen extension140 maintains its position relative to thecentral shaft356 due to the proximal retaining means366, coupled to thelumen extension140.
• G. Release Lumen Extension Proximal Retaining Means
• In the seventh general step of the deployment process, following the withdrawal of the extension catheterouter jacket360, the proximal slidingknob382 on the extensioncatheter handle assembly362 is moved distally, which causes the proximal end of the proximal releasing means370, i.e., theproximal release wire380, to be withdrawn from the proximal retaining means366, i.e., thesuture loop378, and allows the restrained stent orstents150, and theproximal end142 of thelumen extension140, to self-expand radially to the deployment configuration, as seen inFIGS. 70 and 71. Theproximal end142 of thelumen extension140 desirably enlarges to contact the internal walls of thesecond lumen128 of themain body prosthesis140. The natural flow of fluid through thelumen extension140 provides sufficient force to cause the restraint mechanism of thelumen extension140 to engage the co-acting restraint mechanism of themain body prosthesis120. The lumen extension stent and/or outwardly extendingapices147 of thelumen extension stent150 engage the mating outwardly extendingapices136 of thedistal stent134 positioned within thesecond lumen128 of the main body prosthesis120 (as best seen inFIG. 10B) in order to couple thelumen extension140 to themain body prosthesis120.
• Prior to withdrawing theextension catheter350, theouter jacket360 is desirably repositioned in an abutting relationship with thecatheter tip368. Thejacket sliding knob382 on the extension catheter handle362 is urged in a proximal direction to reposition thejacket360 in a pre-deployment configuration. Theextension catheter350 may now be withdrawn and removed from the body. Thesecond guide wire40 may either be removed, or may remain until the deployment process is completed.
• H. Release Second Proximal Retaining Means
• In the eighth general stage of the deployment process, following the deployment of afirst lumen extension140, the second proximal retaining means226 is released. To release theproximal end108 of themain body prosthesis120, the second proximalrelease sliding knob324 on thehandle212 is moved distally, which causes the proximal end of the second proximal releasing means230, i.e., the secondproximal release wire268, to be withdrawn from theprosthesis material112 and the stabilizingarm apertures264, and allows the stabilizingarms256 to release from theproximal end108 of themain body prosthesis120, and spring proximally, as shown inFIG. 72. Theproximal end108 of themain body prosthesis120 is no longer in a restrained relationship with thecentral shaft216.
• I. Release Distal Retaining Means
• In the ninth general stage of the deployment process, following the release of the second proximal retaining means226, the distal retaining means220 is released. To release thedistal end110 of themain body prosthesis140, the distalrelease sliding knob326 on thehandle212 is moved distally, which causes the proximal end of the distal releasing means232, i.e., thedistal release wire282, to be withdrawn from the distal retaining means220, i.e., thedistal suture loop274, and allows the restrained stent orstents134 to self-expand radially to the second stage deployment configuration, as seen inFIG. 73. As previously mentioned, alternatively, the stent orstents140 are not necessarily radially restrained by the distal retaining means226. Themain body prosthesis120 is no longer in a restrained relationship with thecentral shaft216.
• Prior to withdrawing thedeployment catheter200, theouter jacket210 is desirably repositioned in an abutting relationship with thecatheter tip222. Thejacket sliding knob294 on thecatheter handle212 is urged in a proximal direction to reposition thejacket210 in a pre-deployment configuration. Thedeployment catheter200 may now be withdrawn from the body, leaving thefirst guide wire30 within the vasculature (seeFIG. 74).
• J. Position Second Lumen Extension
• In the tenth general stage of the deployment process, following the release of the distal retaining means220 and withdrawal of thedeployment catheter200, thesecond lumen extension140 is positioned, for deployment. The general steps as describe for the deployment of thefirst lumen extension140 are the same or similar, but will be repeated here for clarity. Theextension deployment catheter350 is again used to position thesecond lumen extension140 for deployment within a lumen of themain body prosthesis120. From the left or right femoral artery, for example, under image guidance, theextension catheter350 is navigated over thefirst guide wire30 to the desired location, i.e., telescopically positioned partially within thefirst lumen126 of themain body prosthesis120, asFIG. 75 shows. Again, as previously described, a conventional hemostatic valve arrangement may be used at the access site (shown for purposes of illustration inFIG. 44B).
• K. Retract Extension Catheter Outer Jacket
• Next, the extension catheter'souter jacket360 must be retracted in a distal or caudal direction to expose thelumen extension140. Thejacket sliding knob382 on the extension catheter handle362 is urged, in a distal direction to retract thejacket360 and fully expose thelumen extension140. The unrestrained portion or portions of thelumen extension140 self-expand (seeFIGS. 75 and 76). AsFIG. 76 shows, both during and after retraction of theouter jacket360, thelumen extension140 maintains its position relative to thecentral shaft356 due to the proximal retaining means366, coupled to thelumen extension140.
• L. Release. Lumen Extension Proximal Retaining Means
• In the twelfth general step of the deployment process, following the withdrawal of the extension catheterouter jacket360, the proximal slidingknob382 on the extensioncatheter handle assembly362 is moved distally, which causes the proximal end of the proximal releasing means370, i.e., theproximal release wire380, to be withdrawn from the proximal retaining means366, i.e., thesuture loop378, and allows the restrained stent orstents150, and theproximal end142 of thelumen extension140, to self-expand radially to the deployment configuration, as seen inFIG. 77. Theproximal end142 of thelumen extension140 desirably enlarges to contact the internal walls of thefirst lumen126 of themain body prosthesis140. The natural flow of fluid through thelumen extension140 provides sufficient force to cause the restraint mechanism of thelumen extension140 to engage the co-acting restraint mechanism of themain body prosthesis120. The lumen extension stent and/or the outwardly extendingapices147 of thelumen extension stent150 engage the mating outwardly extendingapices136 of thedistal stent134 positioned within thefirst lumen126 of the main body prosthesis120 (as best seen inFIG. 10B) in order to couple therumen extension140 to themain body prosthesis120.
• Prior to withdrawing theextension catheter350, theouter jacket360 is desirably repositioned in an abutting relationship with thecatheter tip368. Thejacket sliding knob382 on the extension catheter handle362 is urged in a proximal direction to reposition thejacket360 in a pre-deployment configuration. Theextension catheter350 may now be withdrawn and removed from the body. Both thefirst guide wire30 and thesecond guide wire40 may now be removed to complete the deployment process of thebifurcated prosthesis100, as can be seen inFIG. 78.
• It is to be appreciated that the general steps just described do not necessarily need to follow the order in which they were described. For example, the second proximal retaining means may be released prior to the deployment of thefirst lumen extension140, and the second guide wire may be removed prior to the completion of the deployment process. It is also to be appreciated that fasteners may be applied to the lumen extensions as well to connect the lumen extensions to the iliac arteries.
• It will also be appreciated that the components and/or features of the preferred embodiments described herein may be used together or separately, while the depicted methods and devices may be combined or modified in whole or in part. It is contemplated that the components of the guiding device, fastener device, and helical fastener may be alternately oriented relative to each other, for example, offset, bi-axial, etc. Further, it will be understood that the various embodiments may be used in additional procedures not described herein, such as vascular trauma, arterial dissections, artificial heart valve attachment and attachment of other prosthetic device within the vascular system and generally within the body.
• The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
• The desired embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

Claims (4)

1. A method comprising

providing a prosthesis including a proximal region and a distal region, each of the proximal and distal regions being sized and configured for self-expansion between a radially compressed condition and a radially expanded condition,

providing a deployment catheter including a shaft sized and configured to carry the prosthesis, a first proximal release mechanism coupling the proximal region of the prosthesis to the shaft to retain the proximal region in the radially compressed condition, a second proximal release mechanism coupling the proximal region of the prosthesis to the shaft, independent of the first proximal release mechanism, to retain the proximal region coupled to the shaft while the proximal region is in the radially expanded condition, and a distal release mechanism, independent of the first and second proximal release mechanisms, coupling the distal region of the prosthesis to the shaft to retain the distal region the radially compressed condition,

providing a guide device separate from the deployment catheter, the guide device defining a guide passage,

providing a fastener device separate from the guide device and the deployment catheter and being sized and configured to pass through the guide passage, the fastener device carrying at least one fastener,

positioning the deployment catheter at a targeted site in a hollow body organ or blood vessel, the first proximal release mechanism and the distal release mechanisms of the deployment catheter retaining the proximal and distal regions of the prosthesis, respectively, in the radially compressed condition,

actuating the first proximal release mechanism and not the second proximal release mechanism and not the distal release mechanism to release the proximal region of the prosthesis for self-expansion from the radially compressed condition to the radially expanded condition, thereby allowing adjustment of a position of the prosthesis, while the proximal region is in the radially expanded condition, relative to the targeted site by manipulation of the deployment catheter,

deploying the guide device into the proximal region while the proximal region is in the radially expanded condition,

deploying the fastener device through the guide passage of the guide device into the proximal region while the proximal region is in the radially expanded condition,

operating the fastener device to apply the fastener to fasten the proximal region of the prosthesis to the targeted site while the proximal region is in the radially expanded condition,

after applying the fastener, actuating the second proximal release mechanism to release the proximal region of the prosthesis from the deployment catheter, and

actuating the distal release mechanism to allow the distal region of the prosthesis to self expand from the radially compressed condition to the radially expanded condition.

2. A method according toclaim 1

further comprising, after actuating the first proximal release mechanism and before applying the fastener, manipulating the deployment catheter to adjust a position of the prosthesis either longitudinally and/or rotationally relative to the targeted site.

3. A method according toclaim 1

wherein the deployment catheter includes an interlock mechanism to prevent actuation of the second proximal release mechanism before actuation of the first proximal release mechanism.

4. A method according toclaim 1

wherein the prosthesis is longitudinally compliant.

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