Medical device delivery

Information

  • Patent Grant
  • 12109137
  • Patent Number
    12,109,137
  • Date Filed
    Friday, July 30, 2021
    3 years ago
  • Date Issued
    Tuesday, October 8, 2024
    4 months ago
Abstract
A stent delivery system includes a core member and an expandable member coupled to the core member distal segment. A stent extends along the core member distal segment such that an inner surface of the stent is positioned over the expandable member. The stent has a primary heat-set configuration where the stent is radially expanded, and a secondary heat-set configuration where the stent is radially compressed. The expandable member is adapted to radially expand at least a portion of the stent from a radially compressed configuration toward a radially expanded configuration.
Description
TECHNICAL FIELD

The present technology relates to medical device delivery devices, systems, and methods.


BACKGROUND

Walls of the vasculature, particularly arterial walls, may develop areas of pathological dilatation called aneurysms that often have thin, weak walls that are prone to rupturing. Aneurysms are generally caused by weakening of the vessel wall due to disease, injury, or a congenital abnormality. Aneurysms occur in different parts of the body, and the most common are abdominal aortic aneurysms and cerebral (e.g., brain) aneurysms in the neurovasculature. When the weakened wall of an aneurysm ruptures, it can result in death, especially if it is a cerebral aneurysm that ruptures.


Aneurysms are generally treated by excluding or at least partially isolating the weakened part of the vessel from the arterial circulation. For example, conventional aneurysm treatments include: (i) surgical clipping, where a metal clip is secured around the base of the aneurysm; (ii) packing the aneurysm with small, flexible wire coils (micro-coils); (iii) using embolic materials to “fill” an aneurysm; (iv) using detachable balloons or coils to occlude the parent vessel that supplies the aneurysm; and (v) intravascular stenting.


Intravascular stents are well known in the medical arts for the treatment of vascular stenoses or aneurysms. Stents are prostheses that expand radially or otherwise within a vessel or lumen to support the vessel from collapsing. Methods for delivering these intravascular stents are also well known.


Conventional methods of introducing a compressed stent into a vessel and positioning it within an area of stenosis or an aneurysm include percutaneously advancing a distal portion of a guiding catheter through the vascular system of a patient until the distal portion is proximate the stenosis or aneurysm. A second, inner catheter and a guidewire within the inner catheter are advanced through the distal region of the guiding catheter. The guidewire is then advanced out of the distal region of the guiding catheter into the vessel until the distal portion of the guidewire carrying the compressed stent is positioned at the point of the lesion within the vessel. The compressed stent is then released and expanded so that it supports the vessel at the point of the lesion.


SUMMARY

The present technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the present technology are described as alternative embodiments. These are provided as examples and do not limit the present technology.


According to one aspect of the present technology, a stent delivery system includes a core member configured for advancement within a corporeal lumen and an expandable member positioned on the core member, wherein the expandable member is adapted to be radially expanded from a collapsed delivery configuration to an expanded configuration. The system also includes a stent extending along the core member and over the expandable member, the stent comprising a stent delivery configuration wherein the stent is radially compressed against the core member, the stent comprising a stent expanded configuration wherein the stent is radially expanded from the stent delivery configuration. The stent has a primary set configuration toward which the stent is biased wherein the stent is radially larger than the stent expanded configuration, and a secondary set configuration toward which the stent is biased wherein the stent is radially compressed smaller than the stent delivery configuration.


In some embodiments, the expandable member comprises a first end secured to the core member, a second end slidingly secured to the core member, wherein relative movement of the first end toward the second end causes the expandable member to shorten and radially expand, and wherein relative movement of the first end away from the second end causes the expandable member to lengthen and radially compress. In some embodiments, the first end is fixedly secured to the core member. Optionally, the first end is distal to the second end, or alternatively the first end can be proximal of the second end. The expandable member can include a main body having a cylindrical shape when the expandable member is in the collapsed delivery configuration. In various embodiments, the expandable member comprises a slotted hypotube, a laser-cut structure, a braided structure, and/or is self-expanding or selectively expandable (e.g., via an actuator).


In some embodiments, while in the delivery state, the expandable member contacts the stent along less than the entire length of the stent. The system can further include a catheter through which the core member and stent are configured to be slidably advanced. The stent can be formed of a shape memory material (e.g., a shape-memory metal, a shape-memory polymer, etc.). In some embodiments, the stent can be heat-set into the primary set configuration and/or heat-set into the secondary stent configuration.


In another aspect, a stent delivery system includes a core member configured for advancement within a corporeal lumen, an expandable member coupled to the core member, and a stent extending along the core member and over the expandable member. The stent has stent delivery configuration wherein the stent is radially compressed against the core member and comprises a maximum stent delivery diameter, wherein the stent is characterized by the memory material having a secondary set configuration wherein the stent is radially compressed and comprises a secondary stent maximum diameter which is no greater than the maximum stent delivery diameter, and wherein the stent is further characterized by the memory material having a primary set configuration wherein the stent is radially expanded and comprises a primary set maximum diameter which is greater than the maximum stent delivery diameter.


In some embodiments, the stent is adapted to be deployed within a body lumen, wherein the stent after deployment in the body lumen comprises a stent expanded configuration wherein the stent is radially expanded against a wall of the body lumen and wherein the stent comprises a maximum stent expanded diameter which is no greater than the primary set maximum diameter. The stent can be formed of a shape memory material, a shape memory metal, and/or a shape memory polymer. The stent can be heat-set into the primary set configuration and/or heat-set into the secondary set configuration.


According to another aspect of the present technology, a method of manufacturing a stent delivery system includes providing a stent formed from a memory material, setting the stent into a primary set configuration, wherein the primary stent configuration has a primary set configuration minimum stent diameter, and setting the stent into a secondary set configuration. In the secondary stent configuration, the stent has a secondary set configuration minimum stent diameter, wherein the secondary set configuration minimum stent diameter is less than the primary set configuration minimum stent diameter. The method further includes sliding the stent over a stent-receiving surface of an elongated core member, wherein the elongated core member is adapted to be distally advanced through a body lumen of a patient to thereby advance the stent-receiving surface to a desired treatment site in the patient, and securing the stent to the stent-receiving surface of the elongated core member.


In some embodiments, securing the stent to the stent-receiving surface comprises reducing the diameter of the stent until an inner surface of the stent engages the stent-receiving surface. Reducing the diameter of the stent can include reducing the stent to a compressed minimum diameter which is larger than the secondary set configuration minimum stent diameter. Additionally or alternatively, reducing the diameter of the stent can include applying a compressive force onto a radially outer surface of the stent to thereby radially compress the stent onto the stent-receiving surface of the core member.


In some embodiments, the method further includes placing the stent over a hollow mandrel, wherein the hollow mandrel has a mandrel outer diameter sufficient to hold the stent in a configuration wherein the stent is biased toward the secondary stent configuration, and the hollow mandrel has a mandrel inner lumen of sufficient size to slidingly receive therein a portion of the core member on which the stent-receiving surface is positioned. Sliding the stent over the elongated core member can include sliding the hollow mandrel over the stent-receiving surface of the elongated core member, and wherein reducing the diameter of the stent comprises slidingly removing the stent from off of the mandrel while simultaneously maintaining the stent in position over the stent-receiving surface and while also slidingly removing the mandrel from off of the stent-receiving surface of the elongated core member, whereupon the stent will radially collapse toward the secondary configuration minimum stent diameter until the inner surface of the stent engages the stent-receiving surface.


In some embodiments, the method further includes mechanically deforming the stent into a stent mounting configuration wherein an inner lumen of the stent is adapted to slidingly receive the stent-receiving surface of the core member therein, wherein mechanically deforming the stent into the stent mounting configuration occurs prior to sliding the stent over the stent-receiving surface of the elongated core member. The method can further include exposing the stent to a temperature sufficient to cause the stent to be biased away from the stent mounting configuration and to be biased toward the stent secondary configuration.


According to another aspect of the present technology, a stent includes a stent main body formed from a shape memory material and configured to be percutaneously advanced through one or more body lumens of a patient to a target site in a patient's body. The stent main body has a primary set configuration wherein the stent main body comprises a stent primary set maximum diameter and a secondary set configuration wherein the stent main body comprises a stent secondary set maximum outer diameter, wherein the stent primary set maximum outer diameter is greater than the stent secondary set maximum outer diameter.


In some embodiments, the memory material comprises a memory metal and/or a memory polymer. The stent can be biased toward the primary set configuration when the stent is exposed to a temperature at least as high as a primary activation temperature. The stent can be biased toward the secondary set configuration when the stent is exposed to a temperature at least as high as a secondary activation temperature. In some embodiments, the stent is biased toward the primary set configuration when the stent is exposed to the temperature of the patient's body. In some embodiments, the stent primary set maximum outer diameter is at least as large as a largest diameter of the target site in the patient's body.


According to another aspect of the present technology, a method of delivering a stent to a treatment site in a patient's body includes providing a medical device delivery system. The system includes an elongated core member having a core member distal portion with a medical device releasably secured to the core member distal portion, the medical device characterized in having a first set configuration wherein the medical device has a first set maximum diameter, and further characterized in having a second set configuration wherein the medical device has a second set maximum diameter, the medical device further characterized in having a delivery configuration in which the medical device is releasably secured to the core member distal portion. The method further includes advancing the core member distal portion with stent thereon through one or more of the patient's body lumens to a treatment site in the patient's body, releasing the medical device from the core member distal portion, and radially expanding the medical device from the delivery configuration to a deployed configuration, whereby the medical device is deployed at the treatment site.


Additional features and advantages of the present technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the present technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.


It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the present technology as claimed.





BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. For ease of reference, throughout this disclosure identical reference numbers may be used to identify identical or at least generally similar or analogous components or features.



FIGS. 1A and 1B are side cross-sectional illustrations of a medical device delivery system configured in accordance with some embodiments.



FIG. 2 is a side, cross-sectional view of a medical device delivery system, according to some embodiments.



FIGS. 3A and 3B are side perspective views of a stent in accordance with some embodiments.



FIGS. 4A and 4B are side cross-sectional views of the stent of FIGS. 3A and 3B.



FIG. 5 is a side view of a stent in accordance with some embodiments.



FIG. 6 is a side view of a stent in accordance with some embodiments.



FIG. 7 is a side view of a stent in accordance with some embodiments.



FIGS. 8A and 8B are side cross-sectional views of a stent in accordance with some embodiments.



FIG. 9 is a side view of an expandable member in accordance with some embodiments.



FIGS. 10A and 10B are side views of an expandable member in accordance with some embodiments.



FIGS. 11A and 11B are side cross-sectional views of an expandable member in accordance with some embodiments.





DETAILED DESCRIPTION

Self-expanding stents may be advanced into vascular vessels while mounted on a core member, but typically require radial restraint, such as provided by a restraining sheath or surrounding catheter, that prevents unwanted expansion of the self-expanding stent during advancement through a body lumen to a deployment site. In many neurovascular applications and other areas where a stent is advanced into relatively narrow and/or relatively fragile body lumens, the stent can be restrained onto the core member by the inner wall of a catheter through which the core member and stent are advanced. The radially outward force created by a self-expanding stent against the catheter inner wall can make advancement of the stent and core member through and/or out of the catheter difficult due to the friction created by the self-expanding stent pressing radially outwardly toward the catheter inner wall.


A stent formed from a memory material, such as Nitinol, may have a primary set (e.g., heat set) of the stent that sets the stent in an expanded configuration, which permits the stent to radially expand and remain in a desired deployed configuration when deployed at a treatment site. A secondary set (e.g., heat set) of the stent may be added in order to set the stent in a compressed configuration, which helps the stent remain compressed in a delivery configuration against the core member and reduces friction between the stent and the catheter walls through which the stent is advanced, thus reducing the delivery force (i.e., the “pushing” force needed to advance the stent and core member through and out of the catheter lumen). To urge the stent from the delivery configuration toward the deployed configuration, a radially expandable component may be positioned on the core member which may be selectively radially expanded. At least a portion of the stent may be mounted over the radially expandable member, with the radially expandable member adapted to radially expand the stent from the delivery configuration and into the deployed configuration, so that the deployed stent properly engages the body lumen walls upon and after deployment. Expansion of the radially expandable member may be selectively controlled, such as by a wire that when pulled can reduce the length of the radially expandable member, thereby increasing the diameter thereof.


Specific details of several embodiments of the present technology are described herein with reference to FIGS. 1-11B. Although many of the embodiments are described with respect to devices, systems, and methods for delivery of stents, tubular implants such as filters, shunts or stent-grafts and other medical devices, other applications and other embodiments in addition to those described herein are within the scope of the present technology, and can be employed in any of the embodiments of systems disclosed herein, in place of a stent as is typically disclosed. It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Further, embodiments of the present technology can have different configurations, components, and/or procedures than those shown or described herein. Moreover, embodiments of the present technology can have configurations, components, and/or procedures in addition to those shown or described herein and that these and other embodiments may not have several of the configurations, components, and/or procedures shown or described herein without deviating from the present technology.


As used herein, the terms “distal” and “proximal” define a position or direction with respect to a clinician or a clinician's control device (e.g., a handle of a delivery catheter). For example, the terms, “distal” and “distally” refer to a position distant from or in a direction away from a clinician or a clinician's control device along the length of device. In a related example, the terms “proximal” and “proximally” refer to a position near or in a direction toward a clinician or a clinician's control device along the length of device. The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.


Selected Examples of Medical Device Delivery Systems


FIGS. 1A2 depict embodiments of medical device delivery systems that may be used to deliver and/or deploy a medical device, such as but not limited to a stent, into a hollow anatomical structure such as a blood vessel. The stent can comprise a braided stent or other form of stent such as a woven stent, knit stent, laser-cut stent, roll-up stent, etc. The stent can optionally be configured to act as a “flow diverter” device for treatment of aneurysms, such as those found in blood vessels including arteries in the brain or within the cranium, or in other locations in the body such as peripheral arteries. The stent can optionally be similar to any of the versions or sizes of the PIPELINE™ Embolization Device marketed by Medtronic Neurovascular of Irvine, California USA. The stent can alternatively comprise any suitable tubular medical device and/or other features, as described herein. In some embodiments, the stent can be any one of the stents described in U.S. application Ser. No. 15/892,268, filed Feb. 8, 2018, titled VASCULAR EXPANDABLE DEVICES, the entirety of which is hereby incorporated by reference herein and made a part of this specification.



FIG. 1A is a schematic illustration of a medical device delivery system 100 configured in accordance with an embodiment of the present technology. The system 100 can comprise an elongate tube or catheter 102 which slidably receives a core member or core assembly 104 configured to carry a stent 106 through the catheter 102. The depicted stent 106 has a stent proximal region 108 with a stent proximal end 110, and an opposing stent distal region 112 with a stent distal end 114. The depicted catheter 102 has a catheter proximal region 116 and an opposing catheter distal region 118 which can be positioned at a treatment site within a patient, an internal lumen 120 extending from the catheter proximal region 116 to the catheter distal region 118, and an inner wall surface 122 defining the internal lumen 120. At the catheter distal region 118, the catheter 102 has a distal opening 124 through which the core member 104 may be advanced beyond the catheter distal region 118 to expand or deploy the stent 106 within the body lumen 126 so that the stent 106 engages the body lumen wall 128. The catheter proximal region 116 may include a catheter hub (not shown) or catheter handle (not shown). The catheter 102 can define a generally longitudinal dimension extending between the catheter proximal region 116 and the catheter distal region 118. When the delivery system 100 is in use, the longitudinal dimension of the catheter 102 need not be straight along some or any of its length.


The core member 104 is configured to extend generally longitudinally through the lumen 120 of the catheter 102. The core member 104 can generally comprise any member(s) with sufficient flexibility and column strength to move the stent 106 or other medical device through the catheter 102. The core member 104 can therefore comprise a wire, tube (e.g., hypotube), braid, coil, or other suitable member(s), or a combination of wire(s), tube(s), braid(s), coil(s), etc.


An expandable member 130 may be positioned on the core member 104 at a position under at least a portion of the stent 106. The expandable member 130 may be adapted to be selectively radially expanded from a smaller delivery diameter to a larger deployment diameter. Note that a user may be able to selectively vary the size of the larger deployment diameter, such as via controls on a proximal portion (e.g., handle) (not shown) of the core member 104. The expandable member 130 may be adapted to be selectively radially compressed from the larger deployment diameter back down to a smaller diameter, such as to the smaller delivery diameter.


The radially expandable member 130 may be adapted to radially expand outwardly against the stent 106 to radially engage and releasably expand the stent 106 from the core member 104. The radially expandable member 130 may be formed with a main body 140 having a compressed configuration where the main body 140 is substantially cylindrical and lies close to the core member 104 as depicted in FIG. 1A. The radially expandable member 130 may have an expandable member distal end 142 and an expandable member proximal end 144. The expandable member 130 may be adapted to be selectively radially expanded to engage outwardly against the overlying portion of the stent 106.


As depicted in FIG. 1B, with the core member 104 distally advanced with respect to the catheter 102 such that the stent 106 is advanced out of the catheter distal opening 124, as depicted in FIG. 1B, a portion (such as a stent distal portion 112) or all of the stent 106 may radially expand into contact with the wall 128 of the body lumen 126. The distal restraining sheath 134 has been removed from the stent 106, which in the embodiment depicted involved sliding the distal restraining sheath 134 distally off of the stent 106. Radial expansion of the stent portion (or entirety) may be achieved by radial expansion of the radially expandable member 130. Note that the radially expandable member 130 may not expand to the full width of the body lumen, but can instead expand only enough to cause the stent 106 to reach a diameter where the stent is biased toward a larger diameter which is at least as large as, and maybe larger than, the width of the body lumen 126.


In operation, the stent 106 can be moved distally or proximally within the catheter 102 via the core member 104. To move the stent 106 out of the catheter distal opening 124, either the core member 104 is moved distally while the catheter 102 is held stationary, or the core member 104 is held stationary while the catheter 102 is withdrawn proximally, or the core member 104 is moved distally while the catheter 102 is withdrawn proximally. In each of these examples, the core member 104 is moved distally with respect to the catheter 102, such that the stent 106 is advanced distally with respect to the catheter 102, and ultimately out of the catheter distal region 118 and catheter distal opening 124. Conversely, to resheath or otherwise move the stent 106 back into the catheter 102, the relative movement between the core member 104 and the catheter 102 is reversed compared to moving the stent 106 out of the catheter 102. The resulting proximal movement of the stent 106 relative to the catheter 102 enables re-sheathing of the stent 106 back into the distal region 118 of the catheter 102. This is useful when the stent 106 has been partially deployed and a portion of the stent 106 remains disposed with some portion of the system, such as a proximal sheath on the core member 104. The stent 106 can thus be withdrawn back into the distal opening 124 of the catheter 102 by moving the core member 104 proximally relative to the catheter 102. Resheathing in this manner may remain possible until the entirety of the stent 106 is released from the core member and all other non-stent portions of the system.


The stent 106 can be coupled to the core member 104 using any suitable technique, including one or more restraining sheaths, one or more proximal bumpers or pushing elements configured to abut a proximal end of the stent 106, and/or one or more underlying stent engagement members configured to interlock with or otherwise engage the stent 106 and retain the stent 106 in position with respect to the overlying catheter 102.


In some embodiments, a distal restraining sheath (not shown) may be positioned distally of and extending over the stent distal portion 112, restraining the stent distal portion 112 to the core member 104. The distal restraining sheath may have a distal sheath distal end, which may be secured to the core member 104, and a distal sheath proximal end, which may be a free end and may be positioned over the stent distal portion 112. The distal restraining sheath may be adapted to be removed from the stent distal portion 112, such as by sliding distally and/or everting the distal sheath proximal end (aka the free end) toward and potentially distally of the distal sheath distal end (aka the fixed end), thereby releasing the stent distal portion 112 to radially expand outwardly from the core member 104.


Additionally or alternatively, a proximal restraining sheath (not shown) may be included, in addition to or in lieu of a distal restraining sheath (depending on the particular application and system aspects). The proximal restraining sheath can have similar features (e.g., proximal sheath proximal end secured to core member 104, proximal sheath distal end as a free end positioned over stent proximal portion 108, adapted to slide proximally or evert from off the stent 106 to release the stent to expand, etc.).


Some embodiments of the medical delivery system may include spacers and/or stent engagement members and/or other elements such as those disclosed in U.S. patent application Ser. No. 15/951,779, filed Apr. 12, 2018, the entirety of which is hereby incorporated by reference herein and made a part of this specification.


Examples of stent engagement members and other elements are depicted in FIG. 2, which illustrates a side cross-sectional view of another embodiment of a medical device delivery system 200 configured in accordance with an embodiment of the present technology. The delivery system 200 can be configured to carry a stent (or other vascular implant or device) 205 thereon to be advanced through a surrounding catheter to a target site in a patient, similar to the operation described above with respect to FIGS. 1A-1B. (The surrounding catheter is omitted in FIG. 2 for clarity). The delivery system 200 can be advanced distally with respect to a distal end of the catheter to expand or deploy the stent 205 at the target site.


The delivery system 200 can be used with any number of catheters. For example, the catheter can optionally comprise any of the various lengths of the MARKSMAN™ catheter available from Medtronic Neurovascular of Irvine, California USA. The catheter can optionally comprise a microcatheter having an inner diameter of about 0.030 inches or less, and/or an outer diameter of 3 French or less near the distal region. Instead of or in addition to these specifications, the catheter can comprise a microcatheter which is configured to percutaneously access the internal carotid artery, or another location within the neurovasculature distal of the internal carotid artery.


The delivery system 200 can comprise a core member or core assembly 202 configured to extend generally longitudinally through the lumen of a catheter. The core member 202 can have a proximal region 204 and a distal region 206, which can optionally include a tip coil 208. The core member 202 can also comprise an intermediate portion 210 located between the proximal region 204 and the distal region 206. The intermediate portion 210 is the portion of the core member 202 onto or over which the stent 205 extends when the core member 202 is in the pre-deployment configuration as shown in FIG. 2.


The core member 202 can generally comprise any member(s) with sufficient flexibility and column strength to move a stent or other medical device through a surrounding catheter. The core member 202 can therefore comprise a wire, tube (e.g., hypotube), braid, coil, or other suitable member(s), or a combination of wire(s), tube(s), braid(s), coil(s), etc. The embodiment of the core member 202 depicted in FIG. 2 is of multi-member construction, comprising a wire 212 with a tube 214 surrounding the wire 212 along at least a portion of its length. An outer layer 218, which can comprise a layer of lubricious material such as PTFE (polytetrafluoroethylene or TEFLON™) or other lubricious polymers, can cover some or all of the tube 214 and/or wire 212. The wire 212 may taper or vary in diameter along some or all of its length. The wire 212 may include one or more fluorosafe markers (not shown), and such marker(s) may be located on a portion of the wire 212 that is not covered by the outer layer 218 (e.g., proximal of the outer layer 218). This portion of the wire 212 marked by the marker(s), and/or proximal of any outer layer 218, can comprise a bare metal outer surface.


The core member 202 can further comprise a proximal coupling assembly 220 and/or a distal interface assembly 222 that can interconnect the stent 205 with the core member 202. The proximal coupling assembly 220 can comprise one or more stent engagement members 223a-b (together “engagement members 223”) that are configured to mechanically engage or interlock with the stent 205. In this manner, the proximal coupling assembly 220 cooperates with an overlying inner surface of a surrounding catheter (not shown) to grip the stent 205 such that the proximal coupling assembly 220 can move the stent 205 along and within the catheter, e.g., as the user pushes the core member 202 distally and/or pulls the core member proximally relative to the catheter, resulting in a corresponding distal and/or proximal movement of the stent 205 within the catheter lumen.


The proximal coupling assembly 220 can, in some embodiments, include proximal and distal restraints 219, 221 that are fixed to the core member 202 (e.g., to the wire 212 thereof in the depicted embodiment) so as to be immovable relative to the core member 202, either in a longitudinal/sliding manner or a radial/rotational manner. The proximal coupling assembly 220 can also include a plurality of stent engagement members 223 separated by spacers 225a— b (together “spacers 225”). The stent engagement members 223 and spacers 225 can be coupled to (e.g., mounted on) the core member 202 so that the proximal coupling assembly 220 can rotate about the longitudinal axis of the core member 202 (e.g., of the intermediate portion 210), and/or move or slide longitudinally along the core member 202. In some embodiments, the proximal restraint 219 comprises a substantially cylindrical body with an outer diameter that is greater than or equal to an outer diameter of the first spacer 225a. The distal restraint 221 can taper in the distal direction down towards the core member 202. This tapering can reduce the risk of the distal restraint 221 contacting an inner surface of the overlying stent 205, particularly during navigation of tortuous vasculature, in which the system 200 can assume a highly curved configuration. In some embodiments, the distal restraint 221 can have an outside diameter or other radially outermost dimension that is smaller than the outside diameter or other radially outermost dimension of the overall proximal coupling assembly 220, so that distal restraint 221 will tend not to contact the inner surface of the overlying stent 205.


In the proximal coupling assembly 220 shown in FIG. 2, the stent 205 can be moved distally or proximally within an overlying catheter (not shown) via the proximal coupling assembly 220. In some embodiments, the stent 205 can be resheathed via the proximal coupling assembly 220 after partial deployment of the stent 205 from a distal opening of the catheter. For example, the coupling assembly 220 can be configured to engage the stent 205, such as via mechanical interlock with the pores and filaments of the stent 205, abutment of the proximal end or edge of the stent 205, frictional engagement with an inner wall of the stent 205, or any combination of these modes of action. The coupling assembly 220 can therefore cooperate with an overlying inner surface of a catheter (such as the inner wall surface 122 of the catheter 102 of FIGS. 1A-1B) to grip and/or abut the stent 205 such that the coupling assembly 220 can move the stent 205 along and within the catheter, e.g., distal and/or proximal movement of the core member 202 relative to the catheter results in a corresponding distal and/or proximal movement of the stent 205 within the catheter lumen.


The proximal coupling assembly 220 can be configured and function so that the proximal restraint 219 can be made to function as a pushing element by appropriately sizing the outer diameter of the proximal restraint 219 and the length of the first spacer 225a, such that the distal face of the proximal restraint 219 abuts the proximal end or edge of the stent 205. When the proximal coupling element 220 is so arranged, the proximal restraint 219 can transmit at least some, or most or all, distally directed push force to the stent 205 during delivery, and the stent engagement member(s) 223 do not transmit any distally directed push force to the stent 205 during delivery (or transmit only a small portion of such force, or do so only intermittently). The stent engagement member(s) 223 can transmit proximally directed pull force to the stent 205 during retraction or resheathing, and the proximal restraint 219 can transmit no proximally directed pull force to the stent (or it may do so occasionally or intermittently, for example when a portion of the stent 205 becomes trapped between the outer edge of the proximal restraint 219 and the inner wall of the catheter). The first spacer 225a can optionally take the form of a solid tube when the proximal coupling assembly 220 includes a proximal restraint 219 configured as a pushing element.


Although the proximal coupling assembly 220 can be configured in such a manner, with the proximal restraint 219 abutting the stent 205 so that the proximal restraint 219 can be used as a pushing element, the coupling assembly 220 may entail use of the stent engagement members 223 for both distal (delivery) and proximal (resheathing) movement of the stent 205.


Optionally, the proximal edge of the proximal coupling assembly 220 can be positioned just distal of the proximal edge of the stent 205 when in the delivery configuration. In some such embodiments, this enables the stent 205 to be re-sheathed when as little as a few millimeters of the stent remains in the catheter. Therefore, with stents of typical length, resheathability of 75% or more can be provided (i.e., the stent can be re-sheathed when 75% or more of it has been deployed).


With continued reference to FIG. 2, the distal interface assembly 222 can comprise a distal engagement member 224 that can take the form of, for example, a distal device cover or distal stent cover (generically, a “distal cover”), though other configurations are contemplated. The distal engagement member 224 can be configured to reduce friction between the stent 205 (e.g., a distal portion thereof) and the inner surface of a surrounding catheter. For example, the distal engagement member 224 can be configured as a lubricious, flexible structure having a free first end or section 224a that can extend over at least a portion of the stent 205 and/or intermediate portion 210 of the core member 202, and a fixed second end or section 224b that can be coupled (directly or indirectly) to the core member 202.


The distal engagement member 224 can have a first or delivery position, configuration, or orientation in which the distal cover can extend proximally relative to the distal tip, or proximally from the second section 224b or its (direct or indirect) attachment to the core member 202, and at least partially surround or cover a distal portion of the stent 205. The distal engagement member 224 can be movable from the first or delivery orientation to a second or resheathing position, configuration, or orientation (not shown) in which the distal cover can be everted such that the first end 224a of the distal cover is positioned distally relative to the second end 224b of the distal engagement member 224 to enable the resheathing of the core member 202, either with the stent 205 carried thereby, or without the stent 205. As shown in FIG. 2, the first section 224a of the distal engagement member 224 can originate from the proximal end of the second section 224b. In another embodiment, the first section 224a can originate from the distal end of the second section 224b.


The distal engagement member 224 can be manufactured using a lubricious and/or hydrophilic material such as PTFE or Teflon®, but may be made from other suitable lubricious materials or lubricious polymers. The distal cover can also comprise a radiopaque material which can be blended into the main material (e.g., PTFE) to impart radiopacity. The distal engagement member 224 can have a thickness of between about 0.0005″ and about 0.003″. In some embodiments, the distal cover can be one or more strips of PTFE having a thickness of about 0.001″.


The distal engagement member 224 (e.g., the second end 224b thereof) can be fixed to the core member 202 (e.g., to the wire 212 or distal tip thereof) so as to be immovable relative to the core member 202, either in a longitudinal/sliding manner or a radial/rotational manner. Alternatively, as depicted in FIG. 2, the distal engagement member 224 (e.g., the second end 224b thereof) can be coupled to (e.g., mounted on) the core member 202 so that the distal engagement member 224 can rotate about a longitudinal axis of the core member 202 (e.g., of the wire 212), and/or move or slide longitudinally along the core member. In such embodiments, the second end 224b can have an inner lumen that receives the core member 202 therein such that the distal engagement member 224 can slide and/or rotate relative to the core member 202. Additionally, in such embodiments, the distal interface assembly 222 can further comprise a proximal restraint 226 that is fixed to the core member 202 and located proximal of the (second end 224b of the) distal engagement member 224, and/or a distal restraint 228 that is fixed to the core member 202 and located distal of the (second end 224b of the) distal engagement member 224. The distal interface assembly 222 can comprise a radial gap between the outer surface of the core member 202 (e.g., of the wire 212) and the inner surface of the second end 224b. Such a radial gap can be formed when the second end 224b is constructed with an inner luminal diameter that is somewhat larger than the outer diameter of the corresponding portion of the core member 202. When present, the radial gap allows the distal engagement member 224 and/or second end 224b to rotate about the longitudinal axis of the core member 202 between the restraints 226, 228.


In some embodiments, one or both of the proximal and distal restraints 226, 228 can have an outside diameter or other radially outermost dimension that is smaller than the (e.g., pre-deployment) outside diameter or other radially outermost dimension of the distal engagement member 224, so that one or both of the restraints 226, 228 will tend not to bear against or contact the inner surface of the catheter during operation of the core member 202. Alternatively, it can be preferable to make the outer diameters of the restraints 226 and 228 larger than the largest radial dimension of the pre-deployment distal engagement member 224, and/or make the outer diameter of the proximal restraint 226 larger than the outer diameter of the distal restraint 228. This configuration allows easy and smooth retrieval of the distal engagement member 224 and the restraints 226, 228 back into the catheter post stent deployment.


In operation, the distal engagement member 224, and in particular the first section 224a, can generally cover and protect a distal region of the stent 205 as the stent 205 is moved distally through a surrounding catheter. The distal engagement member 224 may serve as a bearing or buffer layer that, for example, inhibits filament ends of the distal region of the stent 205 (where the stent comprises a braided stent) from contacting an inner surface of the catheter, which could damage the stent 205 and/or catheter, or otherwise compromise the structural integrity of the stent 205. Since the distal engagement member 224 may be made of a lubricious material, the distal engagement member 224 may exhibit a low coefficient of friction that allows the distal region of the stent to slide axially within the catheter with relative ease. The coefficient of friction between the distal cover and the inner surface of the catheter can be between about 0.02 and about 0.4. For example, in embodiments in which the distal cover and the catheter are formed from PTFE, the coefficient of friction can be about 0.04. Such embodiments can advantageously improve the ability of the core member 202 to pass through the catheter, especially in tortuous vasculature.


Structures other than the herein-described embodiments of the distal engagement member 224 may be used in the core member 202 and/or distal interface assembly 222 to cover or otherwise interface with the distal region of the stent 205. For example, a protective coil or other sleeve having a longitudinally oriented, proximally open lumen may be employed. In other embodiments, the distal interface assembly 222 can omit the distal engagement member 224, or the distal cover can be replaced with a component similar to the proximal coupling assembly 220. Where the distal engagement member 224 is employed, it can be connected to the distal tip coil 208 (e.g., by being wrapped around and enclosing some or all of the winds of the coil 208) or being adhered to or coupled to the outer surface of the coil by an adhesive or a surrounding shrink tube. The distal engagement member 224 can be coupled (directly or indirectly) to other portions of the core member 202, such as the wire 212.


In embodiments of the core member 202 that employ both a rotatable proximal coupling assembly 220 and a rotatable distal engagement member 224, the stent 205 can be rotatable with respect to the core member 202 about the longitudinal axis thereof, by virtue of the rotatable connections of the proximal coupling assembly 220 and distal engagement member 224. In such embodiments, the stent 205, proximal coupling assembly 220 and distal engagement member 224 can rotate together in this manner about the core member 202. When the stent 205 can rotate about the core member 202, the core member 202 can be advanced more easily through tortuous vessels as the tendency of the vessels to twist the stent 205 and/or core member 202 is negated by the rotation of the stent 205, proximal coupling assembly 220, and distal engagement member 224 about the core member 202. In addition, the required push force or delivery force is reduced, as the user's input push force is not diverted into torsion of the stent 205 and/or core member 202. The tendency of a twisted stent 205 and/or core member 202 to untwist suddenly or “whip” upon exiting tortuosity or deployment of the stent 205, and the tendency of a twisted stent to resist expansion upon deployment, are also reduced or eliminated. Further, in some such embodiments of the core member 202, the user can “steer” the core member 202 via the tip coil 208, particularly if the coil 208 is bent at an angle in its unstressed configuration. Such a coil tip can be rotated about a longitudinal axis of the system 200 relative to the stent, coupling assembly 220 and/or distal engagement member 224 by rotating the distal region 206 of the core member 202. Thus the user can point the coil tip 208 in the desired direction of travel of the core member 202, and upon advancement of the core member the tip will guide the core member in the chosen direction.


An expandable member 240 may be positioned on the core member 202 at a position under the stent. The expandable member 240 is adapted to be radially expanded, thereby causing at least a portion of the stent 205 to radially expand. The expandable member 240 may be positioned on the core member 202 so that the core member 240 underlies a distal portion 242 of the stent 205 (as in the example depicted in FIG. 2). The expandable member 240 may alternatively underlie any portion or even the entirety of the stent, such as the proximal portion 244 of the stent 205, an intermediate portion 246 of the stent 205, the entirety of the stent 205, etc. Multiple expandable members (each of which may be adapted to be selectively and independently expanded from the other of the expandable members) may be positioned under various portions of the stent 205, such as a distal expandable member positioned on the core member at a position under the distal portion 242 of the stent 205, a proximal expandable member positioned on the core member at a position under the proximal portion 244 of the stent 205, an intermediate expandable member positioned on the core member at a position under an intermediate portion 246 of the stent 205, etc.


Note that various components of the delivery system 200 of FIG. 2 can be incorporated into the delivery system 100 of FIGS. 1A-1B, and vice versa. For example, any of the disclosed embodiments of the expandable member 240 of the delivery system 200 can be employed as the expandable member 130 of the delivery system 100. Any of the embodiments of the coupling assembly 220 can be employed with the delivery system 100. Similarly, any of the embodiments of the stent engagement members 223 can be employed with the delivery system 100, and/or any of the embodiments of the spacers 225 can be employed with the delivery system 100. Although many embodiments discussed herein include two engagement members 223, in other embodiments the delivery system 200 can include three, four, or more engagement members separated from one another by additional spacers. The spacing of such additional engagement members can be regular or irregular. For example, in one embodiment a third engagement member can be provided at a position configured to engage a distal region of the overlying stent, while the first and second engagement members engage only a proximal region of the overlying stent.


Additional Examples of Stents

In various embodiments, the stents can take different forms. For example, the shapes and sizes (e.g., lengths and/or diameters) of the stent (in primary, secondary, delivery or deployed configurations), the operational aspects of the stent (e.g., self-expanding, heat-set, etc.), the construction techniques (e.g., braided, laser-cut, etc.), the position of the expandable stent on the core member, the methods and mechanisms by which the stent is expanded/deployed, the methods by which the stent is secured to and released from the core member, and the material selected can all vary to achieve desired operation of the stent. FIGS. 3A-8B illustrate various alternative embodiments of stents. These stents can be incorporated into and combined with the systems and core members and stents described above with respect to FIGS. 1A-2. Additionally, aspects of these stents can be combined and intermixed such that features of any one of these stents (e.g., the diameters, configuration, mechanism of expansion, etc.) can be combined with the features of any of the other delivery systems and/or expandable members disclosed herein (e.g., the type of expandable member, type of delivery system (such as core member), etc.).


Stents may be self-expanding and may have a primary set configuration, and may also have a secondary set configuration. FIG. 3A depicts a stent 300 in a secondary set configuration, where the stent 300 is a substantially cylindrical main body 302 defined by a stent wall 304, where the stent wall 304 can be porous, such as being formed from a mesh and/or with openings which permit the passage of liquid therethrough. The stent 300 may be open at its distal end 306 and/or at its proximal end 308. The stent 300 has a secondary set outer diameter 312a, a secondary set inner diameter 316a, and a secondary set length 314a. Similarly, FIG. 3B depicts the stent in a primary set configuration, where the stent 300 may be substantially cylindrical and has a primary outer diameter 312b and a primary set length 314b. The primary set outer diameter 312b is larger than the secondary set outer diameter 312a. In the particular example depicted in FIGS. 3A-3B, the stent 300 reduces in length as it radially expands, with the primary set length 314b being shorter than the secondary set length 314a. Depending on the particular design and construction of the stent 300, the stent 300 may lengthen, shorten, or remain the same in length between the primary and secondary set configurations.



FIG. 4A depicts the stent 300 of FIGS. 3A-3B in a delivery configuration, wherein the stent 300 is positioned tightly on a core member 318. The portion of the core member 318 on which the stent 300 is positioned may have a core member outer diameter 320 which is at least as large as, and can be slightly larger than, the secondary set inner diameter 316a (depicted in FIG. 3A) of the stent 300, thereby causing the stent 300 when mounted on the core member 318 to be biased radially inwardly against the core member 318 (including any expandable member thereon which may underlie portion(s) of the stent). The stent 300 thus mounted on the core member 318 has a minimum outer delivery diameter 322min, a maximum outer delivery diameter 322max, a minimum inner delivery diameter 324min, and a delivery length 328. Both the minimum and maximum outer delivery diameters 322min, 322max can be the same or larger than the secondary set outer diameter 312a from FIG. 3A, and may be small enough so that the inner surface 330 of the stent 300 engages closely to the outer surface 332 of the core member 318, including the outer surface of an expandable member that may be thereon (not shown). Note that the minimum and maximum outer delivery diameters 322min, 322max can be sufficiently small that the stent 300 during delivery is biased more strongly toward the secondary set configuration and secondary outer diameter 312a of FIG. 3A than to the primary set configuration and primary outer diameter 312b of FIG. 3A. The stent 300 is thus radially exerting an inward force against, and thus held tightly against, the core member 318, and does not exert a radially expansive force against an inner wall 334 of the surrounding catheter 336. Friction between the catheter wall 334/surrounding catheter 336 and the stent 300 is thus reduced, which reduces the pushing and pulling forces needed to advance or withdraw the stent 300 and core member 318 within the catheter lumen 338 and/or out of the catheter distal opening 340. The minimum delivery outer diameter 322min and maximum delivery outer diameter 322max may be equal to or smaller than the inner diameter 342 of the catheter 336.


Note that the various stent diameters and lengths can be selected according to the particular system and application, including the dimensions and shape of the particular lumen where the stent is to be deployed, the inner diameter of any surrounding catheter, the outer diameter of a core member, the diameter and/or length of an expandable member, etc.



FIG. 4B depicts the stent 300 of FIGS. 3A-3B and 4A in a deployed configuration in a body lumen 344, wherein the stent 300 is released and radially expanded and the catheter and core member have been removed. Radial expansion of the stent 300 may be accomplished in part using radial expansion of an expandable member (not shown) on the core member. The stent 300 is radially expanded into contact with the wall 346 of the body lumen 344. The stent 300 has a minimum deployed diameter 348min, a maximum deployed diameter 348max, and a deployed length 350 (with the length 350 measured along a longitudinal axis of the stent 300, which may be curved to comport to curves in the body lumen 344).


Both the minimum and maximum deployed dimensions 348, 350 are the same or smaller than the primary set diameter 312b of FIG. 3A, but the deployed dimensions 348, 350 may be sufficiently large that the deployed stent 300 is biased more strongly toward the primary set diameter 312b of FIG. 3B than to the secondary set diameter 312a of FIG. 3A. This bias toward the primary set diameter 312b keeps the stent 300 radially expanded against the wall 346 of the body lumen 344, and prevents the stent 300 from collapsing toward the secondary set diameter 312a. Note that if even a small portion of the stent 300 has been expanded toward or at the primary set diameter 312b, with the rest of the stent 300 still contracted close to or at the secondary set outer diameter 312a, the small portion of the stent 300 which is already expanded toward or at the primary set diameter 312b may pull outwardly on the remaining (contracted) portion(s) of the stent 300 with sufficient force to cause the entirety of the stent 300 to expand outwardly toward the primary set outer diameter 312b. This bias prevents undesired narrow portions (e.g., bottlenecks) along the stent 300 when deployed, with the radially expanded portions pulling radially outwardly on any adjacent contracted sections to pull them into radially expanded configuration.


Various stent designs may be used. Examples include a braided stent 500, such as that depicted in FIG. 5. The stent 500 has a central portion 502 formed from braided strand (e.g., wire-like) elements 504, with the braided elements 504 extending from the stent distal end 506 to the stent proximal end 508. FIG. 6 depicts a stent 600 formed by cutting a desired pattern into a hypotube, with cutout areas 602 which are cut (e.g., using a laser) out of a cylindrical body 604, with the remaining (non-cutout) portions 606 defining the lattice wall 608 of the stent 600. A stent 700 may be formed from wire 702, which in the particular example of FIG. 7 is formed into a series of sinusoidal coils 704 defining the length of the stent 700. Note that other types of stents may also be used.


Stents may be formed from various materials, including metals (nitinol, stainless steel, cobalt-chromium, etc.), polymers (e.g., shape-memory thermoplastic and thermoset (covalently cross-linked) polymeric materials), bioresorbable materials, and other materials. Setting the primary and secondary stent configurations may be accomplished by forming the stent using memory materials (such as nitinol), which can be heat-set to one or more specific shapes. Set shapes may also be accomplished by using other stent manufacturing and design methods.


A stent may have one or more set shapes (primary and/or secondary) which have different diameters or other variations in dimensions along the length and/or width/diameter of the stent, including symmetrical and non-symmetrical shapes. As depicted in FIG. 8A, a stent 800 in its secondary set shape has a length 806 with different secondary set outer diameters 804a, 804b, 804c along its length. The secondary set outer diameter 804c at the distal end of the stent is relatively large compared to the smaller secondary set outer diameter 804c at the proximal end the distal end and the even smaller secondary set outer diameter 804b in a section proximal of the distal end of the stent 800. As depicted in FIG. 8B, the stent 800 in its primary set shape has primary set outer diameters 808a (distal), 808b (proximal of distal), 808c (proximal) along its length.


Additional Examples of Expandable Members

In various embodiments, the expandable members can take different forms. For example, the length of the expandable member, the varying diameters of the expandable member, the position of the expandable member on the core member, the shape(s) of the expandable member, the mechanism by which the expandable member is expanded and/or contracted, the control of the expandable member, the material selected, and dimensions can all vary to achieve desired operation of the expandable member. FIGS. 9-11B illustrate various alternative embodiments of expandable members. These expandable members can be incorporated into and combined with the systems and core members and stents described above with respect to FIGS. 1A-8B. Additionally, aspects of these expandable members can be combined and intermixed such that features of any one of these expandable members (e.g., the diameters, configuration, mechanism of expansion, etc.) can be combined with the features of any of the other delivery systems and/or stents disclosed herein (e.g., the type of stent, type of delivery system (such as core member), etc.


An expandable member may have a compressed/delivery diameter not significantly greater than the diameters of surrounding portions of the core member. The expandable member may have an expanded diameter which is sufficient to radially expand the overlying portion of the stent to a diameter which is sufficiently large so that that portion of the stent when expanded by the expandable member is biased toward the primary (expanded) set configuration and not toward the secondary (smaller) set configuration. In various embodiments, expandable members can have various lengths, diameters (expanded and contracted), shapes, designs, etc., depending on the particular application and parameters such as the deployment site, stent size/diameters/length, etc.



FIG. 9 illustrates, in partially expanded configuration, another embodiment of an expandable member 900 positioned on a core member 902. The expandable member 900 has a braided main body 904 formed from braided elements 905 and having a distal end 906 and a proximal end 908, and a length 910 and maximum diameter 912. The braided main body 904 is secured at its distal end 906 to a distal collar 914 mounted around the core member central body 916, and the proximal end 908 is secured to a proximal collar 918 mounted around the core member central body 916. At least one of the distal collar 914 and the proximal collar 918 are slidingly secured around the core member central body 916, so that one of the collars 914, 918 can be advanced toward the other collar and can also be moved away from the other collar. Movement of one of the collars 914, 918 toward the other collar causes radial expansion/increased diameter 912 (and reduced length 910) of the expandable member 900. Movement of one of the collars 914, 918 away from the other collar causes radial contraction/reduced diameter 912 (and increased length 910) of the braided main body 904. Selective radial expansion of the expandable member 900 can facilitate expansion and deployment of a stent (not shown), as discussed elsewhere in this application. Additionally or alternatively, the expandable member 900 can be self-expanding such that it is biased towards a radially expanded configuration, while being collapsible to the reduced-diameter configuration for delivery. In various embodiments, one or both of the collars 914 and 918 can be fixed or slidably coupled to the underlying core member 902 depending on the desired configuration.



FIGS. 10A and 10B illustrate, in compressed and expanded configurations, respectively, another embodiment of an expandable member 1000 positioned on a core member 1002. The expandable member 1000 has a main body 1004 which includes openings therethrough. In the example of FIG. 10A, the main body 1004 is a cylindrical form into which openings have been formed, such as by cutting openings therein (e.g., via laser cutting) such as the depicted longitudinal slots 1006 separating longitudinal slats 1008. The expandable member distal end 1010 is secured to a distal collar 1012 mounted around the core member central body 1014, and the expandable member proximal end 1016 is secured to a proximal collar 1018 mounted around the core member central body 1014. At least one of the distal collar 1012 and the proximal collar 1018 are slidingly secured around the core member central body 1014, so that one of the collars 1012, 1018 can be advanced toward the other collar and can also be moved away from the other collar. Movement of one of the collars 1012, 1018 toward the other collar causes the slats 1008 to bend and curve, resulting in radial expansion/increase of the diameter 1020 (and reduced length 1022) of the expandable member 1000, as depicted in FIG. 10B. Movement of one of the collars 1012, 1018 away from the other collar causes radial contraction/reduced diameter 1020 (and increased length 1022) of the expandable member 1000, as depicted in FIG. 10A. Selective radial expansion of the expandable member 1000 can facilitate expansion and deployment of a stent (not shown), as discussed elsewhere in this application. Additionally or alternatively, the expandable member 1000 can be self-expanding such that it is biased towards a radially expanded configuration, while being collapsible toward the compressed configuration to underlie the stent within the catheter. In various embodiments, one or both of the collars 1012 and 1018 can be fixed or slidably coupled to the underlying core member 1002 depending on the desired configuration.



FIGS. 11A and 11B illustrate, in compressed and expanded configurations, respectively, another embodiment of an expandable member 1100 positioned on a core member 1102. The expandable member 1100 has a balloon 1104 which includes an inner reservoir 1106 has an outer diameter 1108 and length 1110. In the example of FIG. 11A, the balloon 1104 is uninflated, with the inner reservoir 1106 substantially or completely empty, so that the balloon 1104 is contracted against the core member inner element 1112. Injection of a gas (e.g., air) and/or liquid (e.g., saline solution) into the balloon inner reservoir 1106, such as via a balloon inflation lumen (not shown), will inflate the balloon 1104 thereby causing radial expansion of the expandable member 1100 to a desired outer diameter 1108, as depicted in FIG. 11B. Subsequent removal of the gas and/or liquid from the inner reservoir 1106 of the balloon 1104 will cause radial contraction/reduction in the diameter 1108 of the expandable member 1100, as depicted in FIG. 11A. Selective radial expansion of the expandable member 1100 can facilitate expansion and deployment of a stent (not shown), as discussed elsewhere in this application.


CONCLUSION

This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown and/or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, in alternative embodiments the steps may have another suitable order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. Accordingly, this disclosure and associated technology can encompass other embodiments not expressly shown and/or described herein.


Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Similarly, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the terms “comprising” and the like are used throughout this disclosure to mean including at least the recited feature(s) such that any greater number of the same feature(s) and/or one or more additional types of features are not precluded. Directional terms, such as “upper,” “lower,” “front,” “back,” “vertical,” and “horizontal,” may be used herein to express and clarify the relationship between various elements. It should be understood that such terms do not denote absolute orientation. Reference herein to “one embodiment,” “an embodiment,” or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.

Claims
  • 1. A stent delivery system, comprising: a core member configured for advancement within a corporeal lumen;an expandable member positioned on the core member such that a first end is secured to the core member and a second end is slidingly coupled to the core member, wherein the expandable member is adapted to be radially expanded from a collapsed delivery configuration to an expanded configuration;an actuator coupled to the expandable member second end and configured such that movement of the actuator selectively expands the expandable member from the collapsed delivery configuration to the expanded configuration, wherein movement of the actuator in a first direction moves the second end toward the first end, thereby causing the expandable member to shorten and radially expand, and wherein relative movement of the actuator in a second direction moves the second end away from the first end, thereby causing the expandable member to lengthen and radially compress;a stent extending along the core member and over the expandable member, the stent having a primary set configuration with a radially expanded state and a secondary set configuration with a radially low-profile state, the stent assuming a stent delivery configuration in which the stent is more strongly biased towards the secondary set configuration such that the stent is radially compressed against the core member until expanded via the expandable member, and wherein the stent is configured such that, after the underlying expandable member expands the stent, the stent is more strongly biased towards the primary set configuration such that the stent continues to expand after the expandable member has finished expanding until the stent assumes a stent expanded configuration in which the stent is radially expanded from the stent delivery configuration, wherein the stent expanded configuration has a greater radial dimension than the expandable member expanded configuration; anda proximal coupling assembly disposed over the core member and underlying a proximal portion of the stent, the proximal coupling assembly positioned proximal to the expandable member, wherein the proximal coupling assembly comprises one or more stent engagement members configured to engage an inner wall of the stent against an overlying catheter,wherein, in the collapsed delivery configuration, the expandable member underlies the stent along less than half the entire length of the stent.
  • 2. The system of claim 1, wherein the expandable member comprises a main body having a cylindrical shape when the expandable member is in the collapsed delivery configuration.
  • 3. The system of claim 1, wherein, in the expanded configuration, the expandable member contacts the stent along less than half of the entire length of the stent.
  • 4. The system of claim 1, further comprising a catheter through which the core member and stent are configured to be slidably advanced.
  • 5. The system of claim 1, wherein the stent is formed from a shape memory material.
  • 6. The system of claim 1, wherein the stent is heat-set into the primary set configuration.
  • 7. The system of claim 1, wherein the stent is heat-set into the secondary set configuration.
  • 8. The system of claim 1, wherein the proximal coupling assembly is configured to enable resheathing of the stent within the overlying catheter after a distal portion of the stent has been expanded via the expandable member.
  • 9. A stent delivery system, comprising: a core member configured for advancement within a corporeal lumen;an expandable member coupled to the core member, the expandable member having a first end and a second end;an actuator coupled to the expandable member and configured such that (1) movement of the actuator in a first direction causes the first end and second end of the expandable member to be moved closer together, thereby expanding the expandable member, and (2) movement of the actuator in a second direction causes the first end and second end of the expandable member to move further apart, thereby collapsing the expandable member;a stent extending along the core member and over the expandable member, the stent comprising a memory material, the stent further comprising a stent delivery configuration wherein the stent is radially compressed against the core member and comprises a maximum stent delivery diameter, wherein the stent is characterized by the memory material having a secondary set configuration wherein the stent is radially compressed and comprises a secondary stent maximum diameter which is no greater than the maximum stent delivery diameter, and wherein the stent is further characterized by the memory material having a primary set configuration wherein the stent is radially expanded and comprises a primary set maximum diameter which is greater than the maximum stent delivery diameter; anda proximal coupling assembly disposed over the core member and underlying a proximal portion of the stent, the proximal coupling assembly positioned proximal to the expandable member, wherein the proximal coupling assembly comprises one or more stent engagement members configured to engage an inner wall of the stent against an overlying catheter,wherein, in the stent delivery configuration, the expandable member underlies the stent along less than half the entire length of the stent, andwherein, when the stent is in the stent delivery configuration, the stent is more strongly biased towards the second set configuration, and wherein, after the underlying expandable member expands the stent, the stent is more strongly biased towards the primary set configuration such that the stent continues to expand after the expandable member has finished expanding.
  • 10. The stent delivery system of claim 9, wherein the stent is adapted to be deployed within a body lumen, wherein the stent after deployment in the body lumen comprises a stent expanded configuration wherein the stent is radially expanded against a wall of the body lumen and wherein the stent comprises a maximum stent expanded diameter which is no greater than the primary set maximum diameter.
  • 11. The system of claim 9, wherein the stent is formed from a shape memory material.
  • 12. The system of claim 9, wherein the stent is heat-set into the primary set configuration.
  • 13. The system of claim 9, wherein the stent is heat-set into the secondary set configuration.
  • 14. The system of claim 9, wherein the expandable member is adapted to be selectively radially expanded from a collapsed delivery configuration to an expanded deployment configuration.
  • 15. A stent delivery system, comprising: a core member configured for advancement within a corporeal lumen; an expandable member coupled to the core member, the expandable member having a first end and a second end; an actuator coupled to the expandable member and configured such that (1) movement of the actuator in a first direction causes the first end and second end of the expandable member to be moved closer together, thereby expanding the expandable member, and (2) movement of the actuator in a second direction causes the first end and second end of the expandable member to move further apart, thereby collapsing the expandable member; anda stent extending along the core member and over the expandable member, the stent comprising a memory material having a primary set configuration in which the stent is radially expanded and a secondary set configuration in which the stent is radially collapsed, wherein the stent is configured to maintain the secondary set configuration until the expandable member expands against the stent to urge the stent radially outwardly to a first expanded state, and wherein the stent is configured to continue expanding after the expandable member has finished expanding such that the stent assumes a second, larger expanded state, wherein in the secondary set configuration, the expandable member underlies the stent along less than half the entire length of the stent; anda proximal coupling assembly disposed over the core member and underlying a proximal portion of the stent, the proximal coupling assembly positioned proximal to the expandable member, wherein the proximal coupling assembly comprises one or more stent engagement members configured to engage an inner wall of the stent against an overlying catheter.
  • 16. The stent delivery system of claim 15, wherein in the secondary set configuration, the stent is biased towards a collapsed configuration in which a radially outermost dimension of the stent is less than a radially outermost dimension of the core member.
  • 17. The stent delivery system of claim 15, wherein in the primary set configuration, the stent is biased towards an expanded configuration in which a radially outermost dimension of the stent is greater than an outermost dimension of the expandable member in an expanded state.
  • 18. The stent delivery system of claim 15, wherein the actuator comprises a pull wire.
  • 19. The stent delivery system of claim 15, wherein the expandable member comprises at least one of: a braid, a mesh, a slotted hypotube, or a coil.
US Referenced Citations (548)
Number Name Date Kind
3416531 Lowell Dec 1968 A
4364391 Toye Dec 1982 A
4425919 Alston et al. Jan 1984 A
4516972 Samson May 1985 A
4723936 Buchbinder et al. Feb 1988 A
4877031 Conway et al. Oct 1989 A
4990151 Wallsten Feb 1991 A
5011478 Cope Apr 1991 A
5026377 Burton et al. Jun 1991 A
5037404 Gold et al. Aug 1991 A
5037427 Harada Aug 1991 A
5061275 Wallsten et al. Oct 1991 A
5098393 Amplatz et al. Mar 1992 A
5108411 Mckenzie Apr 1992 A
5147370 Mcnamara et al. Sep 1992 A
5178158 De Jan 1993 A
5201316 Pomeranz et al. Apr 1993 A
5209734 Hurley et al. May 1993 A
5279562 Sirhan et al. Jan 1994 A
5279596 Castaneda et al. Jan 1994 A
5292311 Cope Mar 1994 A
5318032 Lonsbury et al. Jun 1994 A
5318525 West et al. Jun 1994 A
5318529 Kontos Jun 1994 A
5358493 Schweich et al. Oct 1994 A
5382259 Phelps et al. Jan 1995 A
5389087 Miraki Feb 1995 A
5403292 Ju Apr 1995 A
5437288 Schwartz et al. Aug 1995 A
5445646 Euteneuer et al. Aug 1995 A
5454795 Samson Oct 1995 A
5458605 Klemm Oct 1995 A
5474563 Myler et al. Dec 1995 A
5478349 Nicholas Dec 1995 A
5484444 Braunschweiler et al. Jan 1996 A
5496294 Hergenrother et al. Mar 1996 A
5499975 Cope et al. Mar 1996 A
5522822 Phelps et al. Jun 1996 A
5531721 Pepin et al. Jul 1996 A
5534007 St et al. Jul 1996 A
5545209 Roberts et al. Aug 1996 A
5554139 Okajima Sep 1996 A
5569220 Webster Oct 1996 A
5571135 Fraser et al. Nov 1996 A
5573520 Schwartz et al. Nov 1996 A
5584821 Hobbs et al. Dec 1996 A
5599325 Ju et al. Feb 1997 A
5599326 Carter Feb 1997 A
5601539 Corso Feb 1997 A
5636641 Fariabi Jun 1997 A
5645559 Hachtman et al. Jul 1997 A
5658264 Samson Aug 1997 A
5662622 Gore et al. Sep 1997 A
5676659 Mcgurk Oct 1997 A
5695483 Samson Dec 1997 A
5695499 Helgerson et al. Dec 1997 A
5702373 Samson Dec 1997 A
5702418 Ravenscroft Dec 1997 A
5704926 Sutton Jan 1998 A
5709703 Lukic et al. Jan 1998 A
5711909 Gore et al. Jan 1998 A
5716410 Wang Feb 1998 A
5725513 Ju et al. Mar 1998 A
5725571 Imbert et al. Mar 1998 A
5728063 Preissman et al. Mar 1998 A
5741429 Donadio et al. Apr 1998 A
5743876 Swanson Apr 1998 A
5755777 Chuter May 1998 A
5759173 Preissman et al. Jun 1998 A
5776141 Klein et al. Jul 1998 A
5782811 Samson et al. Jul 1998 A
5791036 Goodin et al. Aug 1998 A
5824041 Lenker et al. Oct 1998 A
5833632 Jacobsen et al. Nov 1998 A
5836925 Soltesz Nov 1998 A
5836926 Peterson et al. Nov 1998 A
5851203 Van Dec 1998 A
5853400 Samson Dec 1998 A
5873866 Kondo et al. Feb 1999 A
5876386 Samson Mar 1999 A
5891112 Samson Apr 1999 A
5897529 Ponzi Apr 1999 A
5897537 Berg et al. Apr 1999 A
5902290 Peacock et al. May 1999 A
5906605 Coxum May 1999 A
5935161 Robinson et al. Aug 1999 A
5938653 Pepin Aug 1999 A
5951494 Wang et al. Sep 1999 A
5951539 Nita et al. Sep 1999 A
5961510 Fugoso et al. Oct 1999 A
5968053 Revelas Oct 1999 A
5968069 Dusbabek et al. Oct 1999 A
5971975 Mills et al. Oct 1999 A
5984963 Ryan et al. Nov 1999 A
6017323 Chee Jan 2000 A
6030371 Pursley Feb 2000 A
6045547 Ren et al. Apr 2000 A
6053903 Samson Apr 2000 A
6053904 Scribner et al. Apr 2000 A
6077258 Lange et al. Jun 2000 A
6077295 Limon et al. Jun 2000 A
6077297 Robinson et al. Jun 2000 A
6083152 Strong Jul 2000 A
6093177 Javier et al. Jul 2000 A
6105651 Leanna Aug 2000 A
6106510 Lunn et al. Aug 2000 A
6106540 Dehdashtian et al. Aug 2000 A
6123723 Konya et al. Sep 2000 A
6126685 Lenker et al. Oct 2000 A
6135992 Wang Oct 2000 A
6149680 Shelso et al. Nov 2000 A
6152912 Jansen et al. Nov 2000 A
6152944 Holman et al. Nov 2000 A
6159219 Ren Dec 2000 A
6165163 Chien et al. Dec 2000 A
6165166 Samuelson et al. Dec 2000 A
6171295 Garabedian et al. Jan 2001 B1
6171296 Chow Jan 2001 B1
6171297 Pedersen et al. Jan 2001 B1
6186986 Berg et al. Feb 2001 B1
6193739 Chevillon et al. Feb 2001 B1
6197015 Wilson Mar 2001 B1
6217565 Cohen Apr 2001 B1
6217566 Ju et al. Apr 2001 B1
6251132 Ravenscroft et al. Jun 2001 B1
6258080 Samson Jul 2001 B1
6264683 Stack et al. Jul 2001 B1
6287315 Wijeratne et al. Sep 2001 B1
6325807 Que Dec 2001 B1
6350278 Lenker et al. Feb 2002 B1
6355027 Le et al. Mar 2002 B1
6358238 Sherry Mar 2002 B1
6358460 Hunt et al. Mar 2002 B1
6368316 Jansen et al. Apr 2002 B1
6371953 Beyar et al. Apr 2002 B1
6383171 Gifford et al. May 2002 B1
6387118 Hanson May 2002 B1
6389087 Heinonen et al. May 2002 B1
6395008 Ellis et al. May 2002 B1
6395017 Dwyer et al. May 2002 B1
6398791 Que et al. Jun 2002 B1
6419693 Fariabi Jul 2002 B1
6425898 Wilson et al. Jul 2002 B1
6428552 Sparks Aug 2002 B1
6443971 Boylan et al. Sep 2002 B1
6458075 Sugiyama et al. Oct 2002 B1
6464684 Galdonik Oct 2002 B1
6468298 Pelton Oct 2002 B1
6475184 Wang et al. Nov 2002 B1
6494907 Bulver Dec 2002 B1
6508804 Sarge et al. Jan 2003 B2
6508805 Garabedian et al. Jan 2003 B1
6508806 Hoste Jan 2003 B1
6517547 Feeser et al. Feb 2003 B1
6554820 Wendlandt et al. Apr 2003 B1
6562021 Derbin et al. May 2003 B1
6562063 Euteneuer et al. May 2003 B1
6576006 Limon et al. Jun 2003 B2
6582460 Cryer Jun 2003 B1
6589227 Soenderskov Jul 2003 B2
6602271 Adams et al. Aug 2003 B2
6607551 Sullivan et al. Aug 2003 B1
6622367 Bolduc et al. Sep 2003 B1
6635047 Forsberg Oct 2003 B2
6638245 Miller et al. Oct 2003 B2
6641564 Kraus Nov 2003 B1
6648654 Hembree Nov 2003 B1
6648874 Parisi et al. Nov 2003 B2
6652508 Griffin et al. Nov 2003 B2
6663614 Carter Dec 2003 B1
6669719 Wallace et al. Dec 2003 B2
6689120 Gerdts Feb 2004 B1
6699274 Stinson Mar 2004 B2
6702782 Miller et al. Mar 2004 B2
6706055 Douk et al. Mar 2004 B2
6716207 Farnholtz Apr 2004 B2
6726659 Stocking et al. Apr 2004 B1
6764504 Wang et al. Jul 2004 B2
6808529 Fulkerson Oct 2004 B2
6814749 Cox et al. Nov 2004 B2
6815325 Ishii Nov 2004 B2
6817995 Halpern Nov 2004 B1
6830575 Stenzel et al. Dec 2004 B2
6837890 Chludzinski et al. Jan 2005 B1
6843802 Villalobos et al. Jan 2005 B1
6858024 Berg et al. Feb 2005 B1
6866660 Garabedian et al. Mar 2005 B2
6866679 Kusleika Mar 2005 B2
6932837 Amplatz et al. Aug 2005 B2
6939353 Que et al. Sep 2005 B2
6945970 Pepin Sep 2005 B2
6960227 Jones et al. Nov 2005 B2
6984963 Pidutti et al. Jan 2006 B2
6989024 Hebert et al. Jan 2006 B2
7001369 Griffin et al. Feb 2006 B2
7011675 Hemerick et al. Mar 2006 B2
7025758 Klint Apr 2006 B2
7074236 Rabkin et al. Jul 2006 B2
7104979 Jansen et al. Sep 2006 B2
7147656 Andreas et al. Dec 2006 B2
7156860 Wallsten Jan 2007 B2
7163523 Devens et al. Jan 2007 B2
7166088 Heuser Jan 2007 B2
7166099 Devens Jan 2007 B2
7166100 Jordan et al. Jan 2007 B2
7172575 El-Nounou et al. Feb 2007 B2
7223263 Seno May 2007 B1
7228878 Chen et al. Jun 2007 B2
7306624 Yodfat et al. Dec 2007 B2
7323000 Monstdt et al. Jan 2008 B2
7331948 Skarda Feb 2008 B2
7357812 Andreas et al. Apr 2008 B2
7371248 Dapolito et al. May 2008 B2
7402151 Rosenman et al. Jul 2008 B2
7404820 Mazzocchi et al. Jul 2008 B2
7427288 Sater Sep 2008 B2
7438712 Chouinard Oct 2008 B2
7445684 Pursley Nov 2008 B2
7473271 Gunderson Jan 2009 B2
7473272 Pryor Jan 2009 B2
7481804 Devens Jan 2009 B2
7507229 Hewitt et al. Mar 2009 B2
7524322 Monstadt et al. Apr 2009 B2
7556634 Lee et al. Jul 2009 B2
7556710 Leeflang et al. Jul 2009 B2
7569046 Zhou Aug 2009 B2
7572290 Yodfat et al. Aug 2009 B2
7582079 Wendlandt et al. Sep 2009 B2
7597830 Zhou Oct 2009 B2
7621904 Mcferran et al. Nov 2009 B2
7641646 Kennedy Jan 2010 B2
7651520 Fischell et al. Jan 2010 B2
7655031 Tenne et al. Feb 2010 B2
7674411 Berg et al. Mar 2010 B2
7691138 Stenzel et al. Apr 2010 B2
7708704 Mitelberg et al. May 2010 B2
7717953 Kaplan et al. May 2010 B2
7740652 Gerdts et al. Jun 2010 B2
7758624 Dorn et al. Jul 2010 B2
7766820 Core Aug 2010 B2
7766896 Kornkven et al. Aug 2010 B2
7780646 Farnholtz Aug 2010 B2
7815600 Al-Marashi et al. Oct 2010 B2
7815608 Schafersman et al. Oct 2010 B2
7815628 Devens Oct 2010 B2
7828790 Griffin Nov 2010 B2
7867267 Sullivan et al. Jan 2011 B2
7879022 Bonnette et al. Feb 2011 B2
7935140 Griffin May 2011 B2
7942925 Yodfat et al. May 2011 B2
7955370 Gunderson Jun 2011 B2
7981148 Aguilar et al. Jul 2011 B2
7993385 Levine et al. Aug 2011 B2
8025692 Feeser Sep 2011 B2
8034095 Randolph et al. Oct 2011 B2
8042720 Shifrin et al. Oct 2011 B2
8048104 Monstadt et al. Nov 2011 B2
8066754 Malewicz Nov 2011 B2
8083791 Kaplan et al. Dec 2011 B2
8088140 Ferrera et al. Jan 2012 B2
8092508 Leynov et al. Jan 2012 B2
8109987 Kaplan et al. Feb 2012 B2
8133266 Thomas et al. Mar 2012 B2
8147534 Berez et al. Apr 2012 B2
8187314 Davis et al. May 2012 B2
8257432 Kaplan et al. Sep 2012 B2
8298276 Ozawa et al. Oct 2012 B2
8317850 Kusleika Nov 2012 B2
8337543 Jordan et al. Dec 2012 B2
8366763 Davis et al. Feb 2013 B2
8382818 Davis et al. Feb 2013 B2
8480701 Monstadt Jul 2013 B2
8579958 Kusleika Nov 2013 B2
8591566 Newell et al. Nov 2013 B2
8597321 Monstadt et al. Dec 2013 B2
8636760 Garcia et al. Jan 2014 B2
8679172 Dorn et al. Mar 2014 B2
8790387 Nguyen et al. Jul 2014 B2
8858613 Cragg et al. Oct 2014 B2
8968383 Johnson et al. Mar 2015 B1
9241782 Besselink Jan 2016 B2
9393141 Gerdts et al. Jul 2016 B2
9433520 Longo Sep 2016 B2
9439795 Wang et al. Sep 2016 B2
9474639 Haggstrom et al. Oct 2016 B2
9775733 Johnson et al. Oct 2017 B2
9782186 Johnson et al. Oct 2017 B2
9827126 Losordo et al. Nov 2017 B2
10786377 Nageswaran et al. Sep 2020 B2
10945867 Nageswaran et al. Mar 2021 B2
11071637 Dawson et al. Jul 2021 B2
11944558 Deen et al. Apr 2024 B2
20010020173 Klumb et al. Sep 2001 A1
20010027310 Parisi et al. Oct 2001 A1
20010029362 Sirhan et al. Oct 2001 A1
20010044591 Stevens et al. Nov 2001 A1
20010049547 Moore Dec 2001 A1
20020029046 Lorentzen et al. Mar 2002 A1
20020045929 Diaz Apr 2002 A1
20020049412 Madrid et al. Apr 2002 A1
20020072789 Hackett et al. Jun 2002 A1
20020107526 Greenberg et al. Aug 2002 A1
20020111666 Hart et al. Aug 2002 A1
20020138128 Stiger et al. Sep 2002 A1
20020156459 Ye et al. Oct 2002 A1
20020156460 Ye et al. Oct 2002 A1
20020165523 Chin et al. Nov 2002 A1
20020188342 Rykhus et al. Dec 2002 A1
20030004539 Linder et al. Jan 2003 A1
20030009208 Snyder et al. Jan 2003 A1
20030050600 Ressemann et al. Mar 2003 A1
20030191451 Gilmartin Oct 2003 A1
20030212410 Stenzel et al. Nov 2003 A1
20030212430 Bose et al. Nov 2003 A1
20040024416 Yodfat et al. Feb 2004 A1
20040092868 Murray May 2004 A1
20040092879 Kraus et al. May 2004 A1
20040111095 Gordon et al. Jun 2004 A1
20040143239 Zhou et al. Jul 2004 A1
20040147903 Latini Jul 2004 A1
20040158230 Hunn et al. Aug 2004 A1
20040181174 Davis et al. Sep 2004 A2
20040193140 Griffin et al. Sep 2004 A1
20040193243 Mangiardi et al. Sep 2004 A1
20040204749 Gunderson Oct 2004 A1
20040220585 Nikolchev et al. Nov 2004 A1
20040230285 Gifford et al. Nov 2004 A1
20040260271 Huyser et al. Dec 2004 A1
20040260384 Allen Dec 2004 A1
20040267348 Gunderson et al. Dec 2004 A1
20050033403 Ward et al. Feb 2005 A1
20050070794 Deal et al. Mar 2005 A1
20050090802 Connors et al. Apr 2005 A1
20050096724 Stenzel et al. May 2005 A1
20050119719 Wallace et al. Jun 2005 A1
20050125051 Eidenschink et al. Jun 2005 A1
20050131449 Salahieh et al. Jun 2005 A1
20050143773 Abrams et al. Jun 2005 A1
20050149160 Mcferran Jul 2005 A1
20050182388 Garabedian et al. Aug 2005 A1
20050182475 Jen et al. Aug 2005 A1
20050228361 Tremaglio Oct 2005 A1
20050240254 Austin Oct 2005 A1
20050267563 Case et al. Dec 2005 A1
20050273149 Tran et al. Dec 2005 A1
20050277949 Que et al. Dec 2005 A1
20060030835 Sherman et al. Feb 2006 A1
20060036309 Hebert et al. Feb 2006 A1
20060058865 Case et al. Mar 2006 A1
20060064123 Bonnette et al. Mar 2006 A1
20060074477 Berthiaume et al. Apr 2006 A1
20060089618 Mcferran et al. Apr 2006 A1
20060095050 Hartley et al. May 2006 A1
20060100687 Fahey et al. May 2006 A1
20060100688 Jordan et al. May 2006 A1
20060116750 Hebert et al. Jun 2006 A1
20060129166 Lavelle Jun 2006 A1
20060178698 Mcintyre et al. Aug 2006 A1
20060184226 Austin Aug 2006 A1
20060212042 Amport et al. Sep 2006 A1
20060217682 Stivland et al. Sep 2006 A1
20060235502 Belluche et al. Oct 2006 A1
20060271093 Holman Nov 2006 A1
20070027520 Sherburne Feb 2007 A1
20070043430 Stinson Feb 2007 A1
20070049903 Jansen et al. Mar 2007 A1
20070078504 Mialhe Apr 2007 A1
20070088323 Campbell et al. Apr 2007 A1
20070100421 Griffin May 2007 A1
20070117645 Nakashima May 2007 A1
20070129706 Katoh et al. Jun 2007 A1
20070149927 Itou et al. Jun 2007 A1
20070161956 Heuser Jul 2007 A1
20070185446 Accisano Aug 2007 A1
20070203563 Hebert et al. Aug 2007 A1
20070233224 Leynov et al. Oct 2007 A1
20070239254 Chia et al. Oct 2007 A1
20070239261 Bose et al. Oct 2007 A1
20070250039 Lobbins et al. Oct 2007 A1
20070250040 Provost et al. Oct 2007 A1
20070255255 Shah et al. Nov 2007 A1
20070255388 Rudakov et al. Nov 2007 A1
20070270779 Jacobs et al. Nov 2007 A1
20070299424 Cumming et al. Dec 2007 A1
20070299500 Hebert et al. Dec 2007 A1
20070299501 Hebert et al. Dec 2007 A1
20070299502 Hiebert et al. Dec 2007 A1
20080009934 Schneider et al. Jan 2008 A1
20080015558 Harlan Jan 2008 A1
20080015678 Kaplan et al. Jan 2008 A1
20080027528 Jagger et al. Jan 2008 A1
20080033399 Hunn et al. Feb 2008 A1
20080033528 Satasiya et al. Feb 2008 A1
20080051705 Von et al. Feb 2008 A1
20080051761 Slazas et al. Feb 2008 A1
20080071301 Matsuura et al. Mar 2008 A1
20080077229 Andreas et al. Mar 2008 A1
20080082083 Forde et al. Apr 2008 A1
20080091169 Heideman et al. Apr 2008 A1
20080097398 Mitelberg et al. Apr 2008 A1
20080108974 Yee May 2008 A1
20080132933 Gerber Jun 2008 A1
20080132989 Snow Jun 2008 A1
20080140180 Dolan et al. Jun 2008 A1
20080147001 Al-Marashi et al. Jun 2008 A1
20080147162 Andreas et al. Jun 2008 A1
20080177249 Heuser et al. Jul 2008 A1
20080188865 Miller et al. Aug 2008 A1
20080188928 Salahieh et al. Aug 2008 A1
20080221666 Licata et al. Sep 2008 A1
20080234660 Cumming et al. Sep 2008 A2
20080234795 Snow et al. Sep 2008 A1
20080243225 Satasiya et al. Oct 2008 A1
20080255541 Hoffman et al. Oct 2008 A1
20080255653 Schkolnik Oct 2008 A1
20080255654 Hebert et al. Oct 2008 A1
20080262471 Warnock Oct 2008 A1
20080262472 Lunn et al. Oct 2008 A1
20080262592 Jordan et al. Oct 2008 A1
20080275426 Holman et al. Nov 2008 A1
20080300667 Hebert et al. Dec 2008 A1
20080312639 Weber Dec 2008 A1
20090012500 Murata et al. Jan 2009 A1
20090082609 Condado Mar 2009 A1
20090105802 Henry et al. Apr 2009 A1
20090125053 Ferrera et al. May 2009 A1
20090132019 Duffy et al. May 2009 A1
20090138066 Leopold et al. May 2009 A1
20090143849 Ozawa et al. Jun 2009 A1
20090149835 Velasco et al. Jun 2009 A1
20090157048 Sutermeister et al. Jun 2009 A1
20090160112 Ostrovsky Jun 2009 A1
20090171319 Guo et al. Jul 2009 A1
20090204196 Weber Aug 2009 A1
20090240235 Murata Sep 2009 A1
20090264985 Bruszewski Oct 2009 A1
20090287182 Bishop et al. Nov 2009 A1
20090287183 Bishop et al. Nov 2009 A1
20090287187 Legaspi et al. Nov 2009 A1
20090287292 Becking et al. Nov 2009 A1
20090299333 Wendlandt et al. Dec 2009 A1
20090299449 Styrc Dec 2009 A1
20090318947 Garcia et al. Dec 2009 A1
20100020354 Ito Jan 2010 A1
20100036363 Watanabe et al. Feb 2010 A1
20100049293 Zukowski et al. Feb 2010 A1
20100049297 Dorn Feb 2010 A1
20100057184 Randolph et al. Mar 2010 A1
20100057185 Melsheimer et al. Mar 2010 A1
20100069852 Kelley Mar 2010 A1
20100087913 Rabkin et al. Apr 2010 A1
20100094258 Shimogami et al. Apr 2010 A1
20100094394 Beach et al. Apr 2010 A1
20100094395 Kellett Apr 2010 A1
20100100106 Ferrera Apr 2010 A1
20100160863 Heuser Jun 2010 A1
20100198334 Yodfat et al. Aug 2010 A1
20100204770 Mas et al. Aug 2010 A1
20100217235 Thorstenson et al. Aug 2010 A1
20100256602 Lippert et al. Oct 2010 A1
20100256603 Lippert et al. Oct 2010 A1
20100262157 Silver et al. Oct 2010 A1
20100268243 Parker Oct 2010 A1
20100268328 Stiger Oct 2010 A1
20100274270 Patel et al. Oct 2010 A1
20100298931 Quadri et al. Nov 2010 A1
20100331951 Bei et al. Dec 2010 A1
20110009943 Paul et al. Jan 2011 A1
20110022157 Essinger et al. Jan 2011 A1
20110029065 Wood et al. Feb 2011 A1
20110034987 Kennedy Feb 2011 A1
20110054586 Mayberry et al. Mar 2011 A1
20110093055 Kujawski Apr 2011 A1
20110098804 Yeung et al. Apr 2011 A1
20110106235 Haverkost et al. May 2011 A1
20110112623 Schatz May 2011 A1
20110137403 Rasmussen et al. Jun 2011 A1
20110152760 Parker Jun 2011 A1
20110160763 Ferrera et al. Jun 2011 A1
20110178588 Haselby Jul 2011 A1
20110190862 Bashiri et al. Aug 2011 A1
20110190865 Mchugo et al. Aug 2011 A1
20110208292 Von et al. Aug 2011 A1
20110224650 Itou et al. Sep 2011 A1
20110257720 Peterson et al. Oct 2011 A1
20110288626 Straubinger et al. Nov 2011 A1
20110319904 Hollett et al. Dec 2011 A1
20120029607 Mchugo et al. Feb 2012 A1
20120035700 Leanna et al. Feb 2012 A1
20120053681 Alkhatib et al. Mar 2012 A1
20120059449 Dorn et al. Mar 2012 A1
20120065660 Ferrera et al. Mar 2012 A1
20120116494 Leynov et al. May 2012 A1
20120123511 Brown May 2012 A1
20120226343 Vo et al. Sep 2012 A1
20120253447 Hayasaka et al. Oct 2012 A1
20120316638 Grad et al. Dec 2012 A1
20130085562 Rincon et al. Apr 2013 A1
20130131775 Hadley et al. May 2013 A1
20130172925 Garcia et al. Jul 2013 A1
20130172979 Fargahi Jul 2013 A1
20130226276 Newell et al. Aug 2013 A1
20130226278 Newell et al. Aug 2013 A1
20130261730 Bose et al. Oct 2013 A1
20130274618 Hou et al. Oct 2013 A1
20130274855 Stante et al. Oct 2013 A1
20130274859 Argentine Oct 2013 A1
20130282099 Huynh Oct 2013 A1
20130304185 Newell et al. Nov 2013 A1
20140025150 Lim Jan 2014 A1
20140031918 Newell et al. Jan 2014 A1
20140094929 Shin Apr 2014 A1
20140148893 Kusleika May 2014 A1
20140171826 Lampropoulos et al. Jun 2014 A1
20140172067 Brown et al. Jun 2014 A1
20140194919 Losordo et al. Jul 2014 A1
20140200648 Newell et al. Jul 2014 A1
20140276541 Ahluwalia et al. Sep 2014 A1
20140277332 Slazas et al. Sep 2014 A1
20150032198 Folk Jan 2015 A1
20150066128 Losordo et al. Mar 2015 A1
20150066129 Nageswaran et al. Mar 2015 A1
20150066130 Haggstrom et al. Mar 2015 A1
20150066131 Luong et al. Mar 2015 A1
20150080937 Davidson Mar 2015 A1
20150133990 Davidson May 2015 A1
20150164666 Johnson et al. Jun 2015 A1
20150238336 Johnson et al. Aug 2015 A1
20160113793 Nishigishi Apr 2016 A1
20160206454 Fischell et al. Jul 2016 A1
20170035592 Haggstrom et al. Feb 2017 A1
20170252161 Tran et al. Sep 2017 A1
20180042745 Losordo et al. Feb 2018 A1
20180200092 Nageswaran et al. Jul 2018 A1
20180263799 Elwood et al. Sep 2018 A1
20180311061 Nolan et al. Nov 2018 A1
20190151124 Hammersmark May 2019 A1
20190314175 Dawson et al. Oct 2019 A1
20190314176 Nageswaran et al. Oct 2019 A1
20190314177 Alonso et al. Oct 2019 A1
20190314179 Nageswaran et al. Oct 2019 A1
20190336312 Nageswaran et al. Nov 2019 A1
20190374358 Nageswaran Dec 2019 A1
20200375769 Nageswaran et al. Dec 2020 A1
20200405517 Barooni Dec 2020 A1
20210196490 Dawson et al. Jul 2021 A1
20220257396 Ashby et al. Aug 2022 A1
20230038177 Deen et al. Feb 2023 A1
Foreign Referenced Citations (17)
Number Date Country
104582643 Apr 2015 CN
105232195 Jan 2016 CN
1344502 Sep 2003 EP
2001504016 Mar 2001 JP
2008518717 Jun 2008 JP
2009542357 Dec 2009 JP
2013500777 Jan 2013 JP
2013158647 Aug 2013 JP
9719713 Jun 1997 WO
9820811 May 1998 WO
2010127838 Nov 2010 WO
2011076408 Jun 2011 WO
2011081997 Jul 2011 WO
2011122444 Oct 2011 WO
2012158152 Nov 2012 WO
2014074462 May 2014 WO
2020072268 Apr 2020 WO
Non-Patent Literature Citations (5)
Entry
Dieter Stoeckel, et al., Self-expanding nitinol stents: material and design considerations, Sep. 3, 2003, Springer-Verlag, pp. 292-301. (Year: 2003).
Stoeckel et al., “Self-expanding nitinol stents: material and design considerations”, Eur Radiol (2004) 14:292-301. (Year: 2003).
International Search Report and Written Opinion mailed May 23, 2022, International Application No. PCT/US2022/012747, 15 pages.
International Search Report and Written Opinion mailed Oct. 15, 2020, International Application No. PCT/US20/70151, 110 pages.
Search Report dated Mar. 24, 2020, CN Application No. 201880007614.9, 10 pages.
Related Publications (1)
Number Date Country
20230029736 A1 Feb 2023 US