This disclosure relates generally to an offset coupling region for use as part of a deployment system for the medical device
Human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, or material that reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, and even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected.
Several procedures are now used to open these stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessels. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing the intraluminal diameter.
Another procedure is atherectomy. During atherectomy, a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material. The catheter includes a rotating blade or cutter disposed in the tip thereof. Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained within the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed.
In another procedure, stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel. The stent typically includes a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size.
Unfortunately, such percutaneous interventional procedures, i.e., angioplasty, atherectomy, and stenting, often dislodge material from the vessel walls. Some existing devices and technology use a filter for capturing the dislodged material from the bloodstream.
Many procedures are performed percutaneously and transluminally using medical devices which are conveyed to the site of the intervention in a contained and/or constrained state which reduces their overall transverse dimension during insertion and transport. Once at the site, the constraint or containment is removed allowing the device to deploy. Related devices of the art employ an actuating member which is sharply curved or even doubly-curved which may lead to binding during the deployment process.
This disclosure relates to a medical device deployment system comprising an elongated guide member having a proximal end and a distal end; a support segment attached near the distal end of the elongated guide member; a medical device disposed adjacent to the support segment; a containment element disposed about a portion of the medical device; an actuation element having a proximal end and a distal end and a first position and a second position, wherein the distal end of the actuation element engages a portion of the containment element in the first position and is at least partially disengaged from the containment element in the second position; and an offset coupling region between the guide member and the support segment, wherein the actuation element extends beyond the distal end of the guide member and generally coaxial with it to engage the containment element at one or more points in the first position.
Another aspect of the disclosure includes a medical device deployment system having an elongated guide member having a proximal end, a distal end, and a lumen associated therewith; an offset coupling region attached to the distal end of the guide member; an actuation element having a proximal end, a distal end, a first position, and a second position; a support segment having a distal end and having a proximal end attached to the offset coupling region, wherein the guide member, the support segment and the actuation element are generally coplanar; a medical device disposed adjacent to the support segment; a containment element disposed about at least a portion of the medical device, wherein the distal end of the actuation element engages at least a portion of the containment element in the first position and is at least partially disengaged from the containment element in the second position; and wherein the actuation element extends beyond the distal end of the guide member and extends generally coaxially with respect to the guide member to engage the containment element at one or more points in the first position.
A further aspect of the disclosure includes a method of deploying a medical device comprising providing an elongated guide member having a proximal end and a distal end; providing a support segment attached near the distal end of the elongated guide member; providing a medical device disposed adjacent to the support segment; providing a containment element disposed about at least a portion of the medical device; providing an actuation element having a proximal end and a distal end and a first position and a second position, wherein the distal end of the actuation element engages at least a portion of the containment element in the first position and is at least partially disengaged from the containment element in the second position; providing an offset coupling region between the guide member and the support segment, wherein the actuation element extends beyond the distal end of the guide member and generally coaxial with it to engage the containment element at one or more points in the first position; advancing the medical device to a desired deployment site; and moving the actuation element from a first position to a second position thereby releasing the medical device from the containment element.
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The drawings, which are not necessarily to scale, are not intended to limit the scope of the claimed invention. The detailed description and drawings illustrate example embodiments of the claimed invention.
All numbers are herein assumed to be modified by the term “about.” The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include the plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
In other embodiments, the medical device may be completely released from the support segment or may remain rigidly affixed to the support segment 26 in the deployed state of the medical device. As illustrated in the embodiments of
In
The embodiments of
In some embodiments, the support segment is generally parallel to and offset from the guide member while in other embodiments, the support segment is angled somewhat toward or away from a line corresponding to the extended guide member. In other embodiments, the majority of the support segment is located distal of the distal end of the guide member. In some embodiments, the offset coupling region connects the guide member to the support segment without intervening elements such as sleeves which accommodate one or both of the distal end of guide member and the proximal end of the offset coupling region and the distal end of the offset coupling region and the distal end of the support segment. It will be appreciated that the coupling of the offset coupling region to the guide member and the support segment respectively may be accomplished in several equivalent ways and that some of the coupling patterns may depart from the generally collinear transitions illustrated herein for convenience. In some embodiments, the offset coupling region comprises a separate coupling element, typically formed from metal, polymer, or reinforced polymer, while in other embodiments, it may be formed, at least in part, from one or both of the guide member and the support segment.
In those embodiments in which a separate coupling element or region is employed, the offset coupling element often comprises a first lumen adapted to receive the guide member and a second lumen adapted to receive the support segment. In addition to the sequential arrangements shown in the various figures, it will be appreciated that the elements may be joined to each other in alternate configurations which also allow the actuation element to pass generally directly from the guide member to engage with the containment element along a line generally extending coaxially from the guide member. The offset coupling region may be disposed near the distal end of the guide member such that the actuation element exits the guide member directly without the need for a separate aperture. In some embodiments, the offset coupling region between the guide member and the support segment may be adapted for rotation about an axis generally coincident with the actuation member and passing through the distal end of the elongated guide member. The guide member, offset coupling region, and support segment, along with any intervening elements, may be joined by adhesives, soldering, welding, crimping, and the like without departing from the spirit of the invention. One or both of the guide member and the support segment may have a reduced cross-sectional area where it is received by the offset coupling element. In some embodiments, the offset coupling region may comprise one or more tapered segments.
In some embodiments, the offset coupling region includes an aperture formed in the offset coupling region and generally aligned with an axial extension of a lumen associated with the guide member such that the actuation element passes through the lumen and the aperture in a straight line. Having passed through the lumen and the aperture, the actuation element generally continues along that same straight line to the point or points of engagement with the containment element when the actuation element is in the first position. In some embodiments, the offset coupling region comprises a double-curved portion of the guide member and the support segment comprises a further distal portion of the guide member. In yet other embodiments, the medical device is longitudinally constrained with regard to motion along the support section, for example, by proximal and/or distal stops. The offset between the guide member and the support segment may serve as a proximal stop to limit translation of the medical device in the proximal direction.
In some embodiments, the actuation element exits the guide member at the proximal end of the guide member. In other embodiments, the actuation element is disposed at least partially within a lumen of the guide member and extends distally from the guide member in the offset coupling region. In yet other embodiments, actuation element enters a lumen of the guide member near the distal end of the guide member in the manner of a single operator exchange catheter and extends distally from the guide member in the offset coupling region.
In some embodiments, the containment element at least partially envelopes at least one of the medical device and the support segment when the actuation element is in the first position. In one configuration, the containment element has one or more apertures formed therein and the actuation element engages one or more apertures in the containment element in the first position and disengages from at least a majority of the one or more apertures in the containment element in the second position. In addition to simple containment, the containment element may provide a constraining force to the medical device when the actuation element is in the first position. When the actuation element is moved from the first position to the second position, the containment and/or the constraining force are removed or otherwise inactivated. It will be appreciated that the transition from the first position of the actuation element to the second position of the actuation element may occur with either distal or proximal motion of the actuation element depending upon the configuration of the points of engagement between the actuation element and the containment element. In other embodiments, the transition from the first position of the actuation clement to the second position of the actuation element may occur with rotation of the actuation element or with some combination of translation and rotation.
In some embodiments, it may be desirable to relieve the guide member and/or the support segment by adding holes, slots, or partial or complete grooves to provide increased flexibility, especially in the vicinity of the offset coupling region. Such relief is believed useful for maintaining a smooth transitional curve in the region as the guide member and the support segment are guided to the site at which the medical device is to be deployed. The holes, slots, or grooves may be uniformly spaced or may be nonuniformly spaced to achieve the desired flexibility profile along the delivery system. One of skill in the art will appreciate that either the guide member or the support segment may be solid or hollow along it respective entire length and that portions of one or both may be solid or hollow in alternate embodiments. For example, in some embodiments, the guide member comprises a lumen adjacent to the proximal end of the offset coupling region and a portion of the actuation member resides within the lumen. The actuation member may exit the guide member proximal the offset coupling region.
Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and principles of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth hereinabove. All publications and patents are herein incorporated by reference to the same extent as if each individual publication or patent was specifically and individually indicated to be incorporated by reference.
This application claims priority to U.S. Provisional Application No. 61/122,614 filed Dec. 15, 2008.
Number | Date | Country | |
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61122614 | Dec 2008 | US |