Abstract: An implantable vein frame is contemplated in which two ring members are rigidly joined in spaced axial alignment via one or more interconnecting members. One of the one or more interconnecting members defines a protruding region that acts upon the implant placed within the frame and/or the vein that the vein frame is placed within to define a sinus region. The implant is placed within and scaffolded by the vein frame, and the vein frame is subsequently inserted within a vein via a venotomy, or interposed between two vein segments via vein interposition graft. The vein frame acts to support the structural integrity of the implant, and to scaffold and anchor the implant in place with the vein.

Abstract: A gastrointestinal balloon system includes a gastrointestinal balloon and a check valve located within the gastrointestinal balloon. The check valve is configured to allow fluid flow into and out of the gastrointestinal balloon. The check valve includes a string coupled to the check valve, the string having a loop on a proximal end and a catheter having a lumen. The lumen is configured to receive a grasping tool. The grasping tool extends out a distal end of the catheter for grabbing the loop to align the catheter with the check valve. Also, a check valve, two-wat valve, and method of using the same in a gastrointestinal balloon.

Abstract: A method of dilating a target anatomical structure of an ear, a nose, or a throat of a patient includes inserting a distal end of a balloon catheter into the ear, the nose, or the throat. The balloon catheter includes a balloon assembly coaxially disposed along a proximally extending shaft. The balloon assembly includes at least first and second dilation balloons that at least partially overlap one another. The method also includes distally advancing the distal end until the balloon assembly is disposed in the target anatomical structure. The method also includes selectively dilating the target anatomical structure based on a diameter of the target anatomical structure by inflating the first dilation balloon to a first diameter or inflating the second dilation balloon to a second diameter that is greater than the first diameter. The second inflation lumen is not in fluid communication with the first inflation lumen.

Abstract: An implantable treatment device configured to facilitate removal thereof after tissue ingrowth into a portion thereof, such as into an enlarged region with a diameter greater than adjacent regions. A liner is positioned within a lumen of the treatment device, with a portion spaced from the enlarged region of the treatment device. A disruption zone in the liner facilitates controlled disruption of the liner's integrity to permit a portion of a removal device inserted within the liner to extend through the liner to interact with the treatment device. The treatment device may be part of a treatment system including a removal device with an enlarged region corresponding to the treatment device enlarged region. A method of treatment involves rupturing a rupture zone in a treatment device liner to allow a portion of a removal device to extend through the liner and into engagement with a portion of the treatment device.

Abstract: Systems, device and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa tissue.

Abstract: A device for withdrawing a sheath from a shaft includes a housing a flexible timing belt that is a continuous band forming a loop that has an inner surface and an outer surface. The timing belt has a plurality of belt teeth on a surface of the timing belt. The delivery device is by rotation of a barrel that is actuated by an actuator coupled to a barrel having a plurality of teeth such that rotation of the barrel such that the barrel teeth engages the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: A prosthetic heart valve, comprising (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b) one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) a water-absorbing polymer coupled to the cuff.

Abstract: Self-expanding implants useful as vascular flow reducers are disclosed with a stabilized throat section to limit the amount of diameter change in certain sections of the implant, for example in the throat section or the center throat ID of an hourglass shape. Methods of making such implants are also described.

Abstract: A stent graft prosthesis includes a fabric sleeve supported by a series of ring stents, including ring stents having a saddle shape with peaks and valleys, the axial alignment of equivalently shaped ring stents in the series of ring stents being such that with respect to at least one shaped ring stent other shaped ring stents are angularly offset. Multiple series of ring stents may be interposed such that at least one ring stent in a first series of ring stents S1-Sn is located between two ring stents in at least one other series of ring stents So1-Son, the angular offset of ring stents in the first series S1-Sn being different from the angular offset of ring stents in at least one other series of ring stents (So1-Son). The offset changes the amount of fabric surface between peripheral contact points of successive shaped ring stents.

Abstract: Provided herein is an occlusion device for intrasaccular implantation and/or vascular occlusion comprising: (a) a substantially solid marker having a proximal end, and a distal end; and (b) a low profile resilient mesh body attached to the distal end of the marker, the body having a delivery shape and a deployed shape capable of conforming to aneurysm walls; wherein the body has a diameter greater than a diameter of an aneurysm to be treated. Also provided herein is a kit comprising the occlusion device disclosed herein and a means for delivery thereof. Methods of manufacture and use of the occlusion device disclosed herein are also disclosed.

Abstract: Devices and methods for treatment of a patient's vasculature are described. Embodiments may include a permeable implant connected to an expandable stent through a plurality of wires. The permeable shell is configured for placement in an aneurysm and the expandable stent is configured for placement in a parent vessel proximal, near, or adjacent the aneurysm.

Abstract: The present application provides polymer materials having the desired properties for implantation into a human or animal body, in particular, biocompatibility, biodegradability, radiopacity and mechanical properties. Methods of making such polymer materials, compositions or devices comprising such polymer materials, and uses of such polymer materials, compositions and devices are also disclosed.

Abstract: An occlusion device with particular utility in occlusion of left atrial appendages is described. The occlusion device utilizes an inflatable balloon comprising a proximal portion to inflate with an inflation fluid delivered by an outer catheter body and conform to a shape of the left atrial appendage and a distal portion to fill with an adhesive delivered by an inner catheter body. The distal portion of the inflatable balloon sticks to the tissue wall of the left atrial appendage. The outer catheter body is configured to position the inner catheter body inside the outer catheter body.

Abstract: An aneurysm implant support device for treating an aneurysm at a bifurcation can include a body having a tubular lattice extending from an upper body section, through a mid body section, and to a lower body section. The upper body section can be sized, shaped, and otherwise configured for implantation in an aneurysm sac. The upper body section can include support elements positioned at the aneurysm neck which inhibit the embolic implants from exiting the aneurysm. The mid body section can have two large cell openings substantially larger than the cell openings over a majority of the tubular lattice. The two large cell openings can be placed across passageways from a stem blood vessel to branch blood vessels of the bifurcation. The lower body section can be sized, shaped, and otherwise configured to anchor within the stem blood vessel.

Abstract: Devices, systems, and methods for treating vascular defects are disclosed herein. One aspect of the present technology, for example, includes an occlusive device comprising a mesh having a low-profile state for intravascular delivery to the aneurysm and a deployed state, the mesh comprising a first end portion, a second end portion, and a length extending between the first and second end portions, and a first lateral edge, a second lateral edge, and a width extending between the first and second lateral edges. The mesh may have a predetermined shape in the deployed state in which (a) the mesh is curved along its width, (b) the mesh is curved along its length, and (c) the mesh has an undulating contour across at least a portion of one or both of its length or its width. The mesh is configured to be positioned within the aneurysm in the deployed state such that the mesh extends over the neck of the aneurysm.

Abstract: A kyphoplasty system disclosed herein includes various instruments which can be selectively used to perform a kyphoplasty operation on a patient. For example, in some embodiments the kyphoplasty system includes an improved detachment mechanism between the balloon implant and its delivery shaft.

Abstract: An implantable vein frame is contemplated in which two ring members are rigidly joined in spaced axial alignment via one or more interconnecting members. One of the one or more interconnecting members defines a protruding region that acts upon the implant placed within the frame and/or the vein that the vein frame is placed within to define a sinus region. The implant is placed within and scaffolded by the vein frame, and the vein frame is subsequently inserted within a vein via a venotomy, or interposed between two vein segments via vein interposition graft. The vein frame acts to support the structural integrity of the implant, and to scaffold and anchor the implant in place with the vein.

Abstract: Enteral tubes, tube tip detection systems, and methods for detecting tube misplacement are provided. For example, a tube tip detection system comprises an enteral tube having a tip and a first light disposed at the tip that is illuminated as the enteral tube is inserted into a patient to indicate to a user of the system whether the tip is misplaced in the patient's airway. Similarly, enteral tubes are provided that comprise a tip, a length, and a light that is continuously illuminated as the enteral tube is inserted into a patient. Methods for detecting a tube misplacement in a patient's airway include embedding a light into an enteral tube, inserting the enteral tube into the patient through the patient's nose or mouth, and monitoring a location of the light as the enteral tube is inserted into the patient to determine if the tube is traveling into the patient's airway.

Abstract: The present disclosure relates to delivery devices for transcatheter stented prosthesis loading, delivery and implantation. The delivery devices provide a loaded delivery state in which the stented prosthesis is loaded and compressed over the delivery device. The compression of the stented prosthesis can be adjusted with one or more elongate tension members, which extend around the stented prosthesis and proximately to an actuation and release assembly that can be provided as part of a handle assembly. The delivery device can be manipulated to adjust tension in the tension members to permit the stented prosthesis to compress, self-expand, and ultimately release from the shaft assembly. In some embodiments, the tension in one or more tension members is adjusted with one or more actuation and release assemblies.

Abstract: Modularizable implants and stents made with bio-absorbable metal wire alloys (‘bio-metals’, e.g. magnesium and alloys), and methods for making such implants and stents. The stents or implants may include one or more wire-formed rings or comprise inter-connected cells that form nets that may serve as modules that are assembled mechanically into stents, without the need for certain manufacturing processes that may affect the durability and physical properties thereof. The wires may be formed into rings mechanically and held in place using joining cuffs, and/or adjacent wires may be secured to one other mechanically using joining cuffs to form nets which can be used as implants or formed into stents. The stents can include radiopaque portions, e.g. associated with one or more joining cuffs, to aid in the positioning and evaluation of stents in the body by serving as visual indicators of alignment and expansion that can be detected using X-rays.

Abstract: An implantable vein frame is contemplated in which two ring members are rigidly joined in spaced axial alignment via one or more interconnecting members. One of the one or more interconnecting members defines a protruding region that acts upon the implant placed within the frame and/or the vein that the vein frame is placed within to define a sinus region. The implant is placed within and scaffolded by the vein frame, and the vein frame is subsequently inserted within a vein via a venotomy, or interposed between two vein segments via vein interposition graft. The vein frame acts to support the structural integrity of the implant, and to scaffold and anchor the implant in place with the vein.

Abstract: A balloon guide catheter system including a balloon guide catheter having a catheter shaft that includes: (i) a main lumen; (ii) an inflation lumen; and (iii) an exhaust lumen. The terminating distal end of the inflation lumen and the terminating distal end of the exhaust lumen being in localized fluid communication with one another underneath the balloon while in a non-inflated state. A balloon is disposed about a distal region of an outer surface of the catheter shaft. The exhaust lumen is configured to purge the residual air in a proximal direction and out from a proximal region of the balloon guide catheter.

Abstract: Aneurysms are treated by placing a scaffold across an aneurysmal sac to provide a blood flow lumen therethrough. An aneurysmal space surrounding the scaffold is filled with one or more expandable structures which are simultaneously or sequentially expanded to fill the aneurysmal space and reduce the risk of endoluminal leaks and scaffold migration. The expandable structures are typically inflatable and delivered by delivery catheter, optionally with an inflation tube or structure attached to the expandable structure.

Abstract: What is disclosed are medical devices comprising a rounded, thin-walled, expandable metal structure (“ballstent”) and a flexible, elongated delivery device (“delivery catheter”) and systems and methods of use for treating saccular vascular aneurysms with the medical devices. Ballstents comprised of gold, platinum, or silver that can be compressed, positioned in the lumen of an aneurysm, and expanded to conform to the shape of the aneurysm are disclosed. The external surface of ballstents can be configured to promote local thrombosis and to promote the growth of tissue into and around the wall of the ballstent in order to seal the aneurysm and fix the ballstent in place in the aneurysm. The wall of the ballstent can also be configured to release drugs or pharmacologically active molecules, such as those that promote thrombosis, cell proliferation, extracellular matrix deposition, and tissue growth.

Abstract: An apparatus and methods for use are provided, where the apparatus includes: (a) a filter, and (b) a frame having a first end and a second end, wherein the frame includes a first support and a second support extending between the first end and the second end, wherein at least the first support and the second support of the frame are coupled to at least a portion of a periphery of the filter, wherein the frame and the filter together define a lumen, wherein the frame has shape memory and is movable between a first position in which the lumen has a first diameter and a second position in which the lumen has a second diameter, and wherein the first diameter is smaller than the second diameter.

Abstract: This intrasacular aneurysm occlusion device includes a neck bridge with a closeable opening through which embolic material is inserted into an aneurysm sac. After the neck bridge has been expanded within the aneurysm sac, a catheter is inserted through the opening and embolic material is delivered through the catheter into the aneurysm sac. After the aneurysm sac has been filled with embolic material, the catheter is then withdrawn and the opening is closed so that embolic material does not escape out of the aneurysm sac.

Abstract: An apparatus and methods tissue restoration are provided. The apparatus may include a catheter shaft extending from a proximal end to a distal tip and a translucent first distal balloon positioned on a translucent distal segment of the catheter shaft inside of and concentric with a second distal balloon proximal to the distal tip in fluid communication with a drug source via a first lumen, the first distal balloon may include first and second outer surfaces, and longitudinal and circumferential channels. A first light fiber and a second light fiber each positioned in the catheter shaft and extending through the translucent distal segment. The drug source provides at least one drug to the first distal balloon via the first lumen.

Abstract: A device for withdrawing a sheath from a shaft includes a housing a flexible timing belt that is a continuous band forming a loop that has an inner surface and an outer surface. The timing belt has a plurality of belt teeth on a surface of the timing belt. The delivery device is by rotation of a barrel that is actuated by an actuator coupled to a barrel having a plurality of teeth such that rotation of the barrel such that the barrel teeth engages the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: Left atrial appendage (LAA) occlusion device including a membrane, a plurality of fixation splines and a deployment hub, the plurality of fixation splines for affixing the LAA occlusion device to an ostium of the LAA, the deployment hub being positioned in the membrane, the deployment hub including a threaded aperture and a one-way valve, for enabling a toxin to be entered into the LAA through the deployment hub.

Abstract: An aneurysm treatment system can include an occlusive member configured to be positioned within an aneurysm sac, and a distal conduit coupled to the occlusive member and having a first lumen extending therethrough. A proximal conduit has a second lumen extending therethrough and is positioned adjacent the distal conduit so that the first lumen is in fluid communication with the second lumen. A coupler extends between the distal conduit and the proximal conduit. The coupler may be ruptured to permit the proximal conduit and the distal conduit to be separated from one another.

Abstract: The invention relates to anchor channels and subannular anchors for a transcatheter heart valve replacement (A61F2/2412), and in particular for an orthogonally delivered transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.

Abstract: Devices used to pressurize, depressurize, or otherwise displace fluid are disclosed. The devices may be configured to displace fluid in order to inflate or deflate a medical device, such as a balloon. The devices may further include a crank member for providing a mechanical advantage when pressurizing or otherwise displacing fluid.

Abstract: A delivery catheter comprises an inner shaft and an outer sheath. A stent-graft is held on a region of the inner shaft. An enlarged diameter distal region of the outer sheath constrains the stent-graft. Its retraction allows the stent-graft to deploy. A finger wheel on a handle is used to retract the outer sheath and is coupled to a sliding block with cable(s). The sliding block is coupled to the outer sheath and is held within a sliding track. The wheel can be actuated to tension the cable(s) and deform latch(es) coupled to sliding block, freeing them from slot(s) in the sliding track and allowing retraction of the sliding block and the outer sheath. A reinforcement sleeve is coupled to a smaller diameter proximal region of the outer sheath. A gap between the outer sheath distal region and the reinforcement sleeve allows the distal outer shaft region to be retracted.

Abstract: Example medical stents are disclosed. An example stent includes a tubular framework including an inner surface, an outer surface and a lumen extending therethrough. Additionally, the stent includes a tissue ingrowth scaffold extending along a portion of the outer surface of the tubular framework, wherein the tissue ingrowth scaffold is spaced radially away from the outer surface of the tubular framework to define an expansion cavity therebetween and wherein the tissue ingrowth scaffold permits tissue ingrowth along a portion thereof. Further, the stent includes an expandable member positioned within at least a portion of the expansion cavity.

Abstract: The present invention relates to a multi-hole stent for digestive organs, the multi-hole stent including: a body configured to form a plurality of cells through the intersection of wires and to be provided in a hollow cylindrical shape; and a film configured to be installed in contact with the inner surface of the body; wherein one or more discharge holes are formed in the film. The multi-hole stent for digestive organs is placed in a stenotic region in a biliary track, and can thus secure a discharge path by restoring a narrowed diameter. Furthermore, the film is installed on the inner surface of the body, and can thus prevent the entry of a lesion into the stent and re-stenosis attributable to the growth of the lesion and can thus provide discharge paths for body fluids generated from side branches through the discharge holes formed in the film.

Abstract: The present invention relates to detachment mechanisms for delivering and releasing implantable devices into a body lumen. According to certain aspects, systems of the invention include a junction that couples an implantable device to a delivery member. The junction includes an anodic portion and a cathodic portion galvanically coupled to the anodic portion such that the anodic portion corrodes when exposed to an electrolytic fluid, thereby detaching the implantable device from the delivery member without application of energy from an external power source.

Abstract: An implantable vein frame is contemplated in which two ring members are rigidly joined in spaced axial alignment via one or more interconnecting members. One of the one or more interconnecting members defines a protruding region that acts upon the implant placed within the frame and/or the vein that the vein frame is placed within to define a sinus region. The implant is placed within and scaffolded by the vein frame, and the vein frame is subsequently inserted within a vein via a venotomy, or interposed between two vein segments via vein interposition graft. The vein frame acts to support the structural integrity of the implant, and to scaffold and anchor the implant in place with the vein.

Abstract: Embodiments of the present invention provide a method for treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease, and chronic sinusitis, including cystic fibrosis, interstitial fibrosis, chronic bronchitis, emphysema, bronchopulmonary dysplasia and neoplasia. The method involves administration, preferably oral, nasal or pulmonary administration, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues) and an additive.

Abstract: A valve delivery system and valve delivery method are disclosed. The valve delivery system includes an inner shaft extending along a longitudinal axis and an elongated tension member to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state, the elongated tension member extending from the sheath portion along the longitudinal axis of the inner shaft.

Abstract: A stent for use in a medical procedure having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices. One or more such stents may be attached to a graft material for use in endovascular treatment of, for example, aneurysm, thoracic dissection, or other body vessel condition.

Abstract: An implant delivery catheter enables permanent modification of the implant length in the vicinity of the treatment site prior to radial expansion thereof. The implant is releasable carried between inner and outer tubular members of the delivery catheter which, upon repositioning relative to one another using an actuator mechanism, impart any of tensile, compressile or torquing forces to the implant causing permanent modification of the implant length. In one embodiment, the circumference of the implant is substantially similar both before and after modification of the implant length. In another embodiment, the implant includes a plurality of strut sections interconnected by bridges which are capable of the deformation along the longitudinal axis of the implant.

Abstract: A vascular occlusion device includes a braided filament mesh structure defining a longitudinal axis. The mesh structure has a relaxed configuration in which it has an axial array of radially-extending occlusion regions, each of which has a proximal side and a distal side meeting at a peripheral edge, the sides of each occlusion region forming a first angle relative to the longitudinal axis. Each occlusion region is axially separated from the adjacent occlusion region by a reduced-diameter connecting region. The mesh structure is radially compressible to a compressed state in which it is deployed intravascularly to a target site through a catheter. Upon deployment, the device radially expands to a constrained configuration in which the peripheral edges of the occlusion regions engage the vascular wall, and the sides of the occlusion regions form a second angle relative to the longitudinal axis that is smaller than the first angle.

Abstract: A stent delivery device including an elongate shaft having a proximal region, a distal region and at least one lumen extending therein. The stent delivery device also includes a collapsible frame attached to the distal region of the elongate shaft. The collapsible frame includes a plurality of arms configured to surround a stent such that the plurality of arms define a stent containment region. The stent delivery device also includes an inner member extending within a least a portion of the stent containment region and an actuation member configured to actuate the plurality of arms of the collapsible frame from an expanded configuration to a collapsed configuration.

Abstract: A medical device is provided that comprises: (i) an expandable capsule that can be swallowed by a patient and positioned to a target tissue within the patient, (ii) an endoscope attached to the capsule for obtaining an image of the target tissue at a wavelength of interest, and (iii) a thin tube or wire configured to position the device to the target tissue. The thin tube or wire is expandable. The capsule can be swallowed in stages to position the device at different locations within the gastrointestinal tract. The thin tube or wire can deliver electromagnetic radiation for visualization of the target tissue. The thin tube or wire can provide a passage of a biopsy device for access to the target tissue. In some instances, the capsule comprises a band which rotates around the capsule to clean the capsule. In some instances, the capsule collects multispectral or hyperspectral information.

Abstract: The disclosure describes a method including manufacturing a shape memory polymer fabric with a collection of shape memory polymer fibers such that the resulting shape memory polymer fabric has a glass transition temperature of greater than 50 degrees centigrade. The method further includes training the shape memory polymer fabric with a pre-determined percentage of strain between an expanded shape and a contracted shape. The method further includes preparing a portion of the shape memory polymer fabric into a shape that is sized to cover two portions of a ruptured soft tissue of an animal with a mean body temperature below 40 degrees centigrade while the fabric has the predetermined percentage of strain stored in the expanded shape.

Abstract: Medical devices and delivery systems for delivering medical devices to a target location within a subject. In some embodiments the medical devices can be locked in a fully deployed and locked configuration. In some embodiments the delivery systems are configured with a single actuator to control the movement of multiple components of the delivery system. In some embodiments the actuator controls the independent and dependent movement of multiple components of the delivery system.

Abstract: A production method for a medical linear member is provided which is not abraded upon production and which includes a flat shape in a cross section. The method includes the steps of: forming a first spiral body (1) of an oval shape in a horizontal section by spirally winding a base body (3), in which a plurality of wires (2) formed of a shape-memory alloy is arrayed, around a winding core (4); subjecting the first spiral body (1) to first shape-memory treatment; cutting the first spiral body (1) into a first predetermined length; forming a second spiral body (5) of a flat shape in a horizontal section by compressing the first spiral body (1) in a direction along a short diameter; subjecting the second spiral body (5) to second shape-memory treatment; and removing the winding core (4) from the second spiral body (5).

Abstract: A stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft. A proximal constraining arrangement is engaged with a proximal end of the stent. A distal constraining arrangement is engaged with a distal end of the stent. A release wire is disposed through the elongate shaft and releasably engaged with portion of the proximal constraining arrangement and the distal constraining arrangement member. A handle assembly comprising a shuttle and a spring arrangement is positioned therein. A first brake assembly is disposed within the handle assembly and a second brake assembly is disposed within the handle assembly proximal to the first brake assembly.

Abstract: This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Abstract: A device for repairing a native heart valve includes a reinforcing structure configured to couple to a portion of the native heart valve to remodel a geometry of the native heart valve, and at least one supporting member connected to the reinforcing structure.