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  Deployment system for an endoluminal deviceUSPTO Application #: 20070093886Title: Deployment system for an endoluminal device Abstract: The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line. (end of abstract) Agent: Gore Enterprise Holdings, Inc. - Newark, DE, US Inventors: Edward H. Cully, Mark J. Ulm, Michael J. Vonesh USPTO Applicaton #: 20070093886 - Class: 623001120 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Stent Combined With Surgical Delivery System (e.g., Surgical Tools, Delivery Sheath, Etc.), Expandable Stent With Constraining Means The Patent Description & Claims data below is from USPTO Patent Application 20070093886. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of application Ser. No. 10/346,598 filed Jan. 17, 2003. FIELD OF THE INVENTION [0002] The present invention relates generally to implantable medical device assemblies. In particular, the invention relates to means for deploying an endoluminal device within vascular or cardiac structures of an implant recipient. BACKGROUND OF THE INVENTION [0003] Various implantable medical devices for repairing or reinforcing cardiac and vascular structures have been developed in recent years. Some of these devices can be implanted inside a particular vascular or cardiac structure through so-called interventional, or endovascular, techniques. Interventional techniques involve surgically accessing the vascular system through a conveniently located artery or vein and introducing distal portions of a medical device assembly into the vascular system through the arterial or venous access point. Once the medical device assembly is introduced into the vascular system, it is threaded through the vasculature to an implantation site while proximal portions of the assembly having manually operated control means remain outside the body of the implant recipient. The medical device component of the assembly is then deposited at the implantation site and the remainder of the distal portion of the medical device assembly removed from the vascular system through the access point. [0004] Exemplary interventional medical device assemblies include a catheter. The catheter can be used to precisely position the medical device at an implantation site as well as participate in deployment of the medical device at the implantation site. Some catheters have guidewires running their length to aid in positioning and deployment of the medical device. As an alternative to the guidewire, a catheter may be coaxial with an inner sleeve running inside the length of the catheter. The inner sleeve is used to hold an implantable medical device in position while the outer catheter is pulled, causing deployment of the device. Handles, knobs, or other manually operated control means are attached to the opposite end of the catheter in this assembly. [0005] Some implantable medical devices, such as stents, stent-grafts, or other endoluminal devices often require reconfiguration from an initial compacted form to an expanded cylindrical configuration as the device is deployed at an implantation site. These devices can expand on their own by virtue of the design and composition of their structural elements or through the use of an inflatable balloon placed inside the devices. [0006] Self-expanding endoluminal medical devices are maintained in a compacted configuration in a variety of ways. Some devices are maintained in a compacted configuration by simply confining the compacted devices inside a catheter, or similar tool. Other devices are placed inside a sheath following compaction. In these assemblies, a control line is often used to assist in releasing the endoluminal device from the sheath. [0007] In U.S. Pat. No. 6,352,561, issued to Leopold et al., a sheath is formed around an expandable endoluminal device and a control line used to maintain the sheath around the endoluminal device. The sheath is formed by folding a length of polymeric material in half and stitching the opposing edges together with the control line. The stitching pattern permits the control line to be removed from the sheath by pulling on a proximal end of the control line. As the control line becomes unstitched from the sheath, the endoluminal device is progressively released from confinement within the sheath. The control line is removed from the assembly as a distinct entity while the sheath remains at the implantation site. [0008] In U.S. Pat. No. 5,647,857, issued to Anderson et al., an endoluminal device is held in a collapsed configuration over a catheter by a sheath. The assembly is provided with a control line having a free end and an end attached to a collar component of the catheter. The sheath is removed from the endoluminal device by pulling on the control line. As the control line is pulled, it cuts through and splits the sheath material from distal end to proximal end. As the sheath splits open, the endoluminal device is freed to expand. Unlike Leopold et al., the control line remains mechanically attached to the sheath and catheter assembly following deployment of the endoluminal device. [0009] In U.S. Pat. No. 6,447,540, issued to Fontaine et al., a confining sheath is removed from around an endoluminal device with a control line that cuts through and splits the sheath material when pulled by a practitioner, much like Anderson et al. As with Leopold et al, the control line can be completely removed from the assembly as a distinct entity. [0010] In U.S. Pat. No. 5,534,007, issued to St. Germain et al., a single-walled sheath that can collapse and shorten along its length is placed around a stent. As the distal portion of the sheath is retracted, it uncovers the stent. The uncovered stent is free to expand. A control line can be used to exert a pulling force on the collapsible sheath as a means of removing the sheath from the stent. The control line remains attached to the sheath during and subsequent to deployment of the stent. [0011] In U.S. Pat. No. 6,059,813, issued to Vrba et al, a double-walled confinement sheath for an endoluminal device is described. In an assembly made of these components, the endoluminal device is placed over a catheter shaft in a collapsed configuration. An outer tube is placed in slidable relationship over the catheter. The distal end of the outer tube does not extend to cover the endoluminal device. Rather, the double walled sheath is placed over the collapsed endoluminal device. The inner wall of the sheath is attached to the catheter shaft near the proximal end of the endoluminal device. The outer wall of the double-walled sheath is mechanically attached to the outer tube. Movement of the outer tube relative to the catheter causes the outer wall of the sheath to move past the inner wall of the sheath. Movement of the outer tube in the proximal direction causes the sheath to retract and uncover the underlying endoluminal device. As the sheath retracts, the endoluminal device becomes free to expand. A control line is mechanically attached to the outer tube and serves to move the outer tube and retract the sheath. [0012] None of these medical device assemblies utilize a control line that is integral with a confining sheath. Nor do these assemblies feature a sheath that is convertible to a control line as the sheath is removed from around the endoluminal device. Such an integral control line and confining sheath would preferably be made of a continuous thin-walled material or composite thereof. The thin-walled material would be flexible and exert minimal restrictions on the flexibility of an underlying endoluminal device. Thin-walled materials would also reduce the profile of the sheath and endoluminal device combination. An integral control line and confining sheath would simplify manufacture of control line--sheath constructs by eliminating the need to mechanically attach the control line to the sheath. An integral control line and confining sheath would also eliminate concerns regarding the reliability of the mechanical attachment of the control line to the sheath. SUMMARY OF THE INVENTION [0013] The present invention is directed to a deployment system for an expandable endoluminal device. In preferred embodiments, the endoluminal device is self-expanding as a consequence of the device design and the materials used to construct the device. In other embodiments, the endoluminal device is expanded with an inflatable balloon placed within the device. The endoluminal device is maintained in a compacted, or collapsed, configuration by a removable sheath. The sheath is removed from around the endoluminal device by pulling on a deployment line. The deployment line is an integral, continuous, extension of the sheath that is made of the same material as the sheath. As the deployment line is pulled, the sheath progressively retracts from around the endoluminal device and also functions as an extension of the deployment line. When the sheath has been substantially removed from around a portion of the endoluminal device, that portion of the endoluminal device is free to expand. Removal of the sheath may be continued until the entire endoluminal device is freed from radial constraint. The deployment line, along with any remaining sheath material, may be removed from the implantation site through the use of a catheter used to deliver the sheathed endoluminal device to the site. [0014] The removable sheath is made of one or more thin, flexible polymeric materials including composites thereof. The sheath ordinarily assumes the form of a continuous thin-walled tube when constraining an endoluminal device. Such a thin-walled sheath exerts minimal resistance to longitudinal flexing of an underlying endoluminal device. The thin-walled sheath also reduces the profile of the sheath--endoluminal device combination, when compared to conventional constraints. In preferred embodiments, a double-walled tubular sheath is used. Double walls enable the sheath to be retracted from around an endoluminal device by rolling or sliding one wall past the other wall. As the sheath is retracted in this manner, the sheath portion does not rub or scrap against the endoluminal device. This is particularly advantageous when coatings containing medications or pharmaceuticals are placed on surfaces of the endoluminal device that may be removed by a sheath that rubs or scrapes against the endoluminal device during removal. [0015] The deployment line is formed from the same material as the tubular sheath and is an integral extension of the sheath material. The deployment line extends from the sheath through a delivery catheter to a control knob located at the proximal end of the catheter. Pulling on the control knob actuates the deployment line. Once the deployment line is actuated, the removable sheath begins to retract from around the endoluminal device. [0016] In one embodiment, as removed sheath material travels beyond the receding end of the sheath, the sheath begins to become converted to deployment line. Conversion of the sheath into the deployment line usually begins at a point where the tubular sheath breaks apart, separates, and converges into deployment line material. In preferred embodiments, means are provided for initiating or sustaining the conversion of the sheath to deployment line. These means may take the form of perforations, stress risers, or other mechanical weaknesses introduced into the sheath material. The means can also be cutting edges or sharp surfaces on the delivery catheter. [0017] In preferred embodiments, materials and/or composites exhibiting compliance, compressibility, and/or resilience are placed between the endoluminal device and the delivery catheter. The compliant material serves to cushion the endoluminal device when constrained by the sheath and may assist in expansion of the device when unconstrained. The compliant material also serves to anchor and retain the endoluminal device in place on the underlying catheter shaft. When used in combination with a double-walled sheath, the compliant material can have tacky surfaces that further assist in anchoring and retaining the endoluminal device. In these embodiments, the tacky surface of the compliant material do not interfere with removal of the sheath from around an endoluminal device. The anchoring of the endoluminal device via the compliant material eliminates the need for barrier, or retention means at either end of the endoluminal device. The absence of barrier means also contributes to a reduction in the profile and an increase in flexibility of the distal portion of the assembly. The present invention can also be provided with an additional catheter or catheter lumen for the deployment line in order to prevent the deployment line from leaving the general path established by the delivery catheter. [0018] Accordingly, one embodiment of the present invention is a deployment system for a self-expanding endoluminal device comprising a removable sheath adapted to cover the endoluminal device, the sheath comprising a thin continuous film adapted to surround at least a portion of the endoluminal device and constrain the device in an introductory profile, wherein the deployment system includes a deployment line integral with the sheath to effectuate device deployment, and wherein upon deployment, the sheath separates from the endoluminal device through actuation of the deployment line, the sheath becoming removed from the device along with the deployment line. [0019] In another embodiment, the present invention is a deployment system for a self-expanding endoluminal device comprising a self-expanding endoluminal device at least partially enclosed by a removable sheath, and a deployment line integral with the sheath, wherein the sheath is convertible to the deployment line as the sheath is removed from the endoluminal device. [0020] These enhanced features and other attributes of the deployment system of the present invention are better understood through review of the following specification. Continue reading... Full patent description for Deployment system for an endoluminal device Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Deployment system for an endoluminal device patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. 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