Abstract: In an aspect, a device includes a body structure including a core and a sleeve disposed around at least a portion of the core, the core defining a channel through the core extending from a first end of the core to a second end of the core, the sleeve including a flange adjacent the second end of the core; and a deployable portion coupled to the body structure adjacent the first end of the core, the deployable portion having a wired structure transitionable between a retained configuration and a deployed configuration, wherein a top portion of the wired structure extends beyond the first end of the core in a longitudinal direction when the wired structure is in the retained configuration, and wherein first end of the core extends beyond the top portion of the wired structure when the wired structure is in the deployed configuration.

Abstract: Disclosed are implant and method for gradually restricting vascular blood flow in a host blood vessel. The implant N comprising an elongated body and at least one holding member. Implant body comprising a flow restricting portion enclosing a variable minimal internal diameter. Holding member is configured for restraining implant body to maintain the variable minimal internal diameter in a first minimal internal diameter, and to physically yield voluntarily after a first predetermined average duration of being continuously subjected to internal human body conditions, thereby releasing and allowing the implant body to elastically deform voluntarily such that the variable minimal internal diameter changes to a second minimal internal diameter, smaller than the first minimal internal diameter.

Abstract: A blood pump for supporting a patient's heart includes a flow cannula having a distal portion including a distal end and a proximal portion including a proximal end opposite the distal end, the distal end of the flow cannula configured to be connected to the patient's heart or a blood vessel to establish fluid communication between the blood pump and the patient's heart and blood vessel, respectively. The flow cannula further includes an intermediate portion attached to the distal portion and the proximal portion, wherein the intermediate portion allows twisting thereof with a lower force than the distal portion and the proximal portion. The intermediate portion can be fully occluded by twisting it. At least a portion of the intermediate portion either alone or in combination with the distal portion is adapted to be permanently attached to the patient's heart or a blood vessel.

Abstract: The present disclosure provides diagnostic methods for evaluating a urinary bladder and methods of enhancing the visibility of the bladder from outside of a patient. The method includes introducing urinary catheter having a proximal end and a distal end into a patient's urinary bladder by way of the urethra, the urinary catheter including an outer tubular member including an inflatable balloon disposed thereon, and a visualization stylet that is slidably disposable within a passage defined in the outer tubular member. The method further includes inflating the inflatable member inside of the bladder, inflating the bladder with a liquid to enhance visualization of an inner surface of the bladder, illuminating a light source through the inflatable member to illuminate the inner surface of the bladder, and visualizing an inner portion of the bladder using the visualization stylet.

Abstract: Provided is a device for use in anastomosis particularly (although not exclusively) suitable for anastomosis of tubular organs within the body, particularly small tubular organs (such as blood vessels, bile duct, lymph duct, nerve ducts, epididymis, etc.).

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: The present invention relates to apparatus ad methods for correcting nasal valve collapse comprising a device configured for suspending a nasal valve, the device comprising a body portion comprising a proximal end, a distal end, and a plurality of barbs, wherein the body portion is configured to be inserted through or underneath the upper lateral cartilage of a patient and wherein the plurality of barbs are configured to engage a soft tissue overlying a bony tissue proximal to the upper lateral cartilage, and a head portion coupled to the proximal end of the body portion wherein the head portion is configured to engage the upper lateral cartilage of the patient when the plurality of barbs are engaged with the soft tissue overlying the bony tissue proximal to the upper lateral cartilage.

Abstract: Methods and apparatuses for applying tensile force to one or more tissue regions within a body. Illustratively, an implant ball including a spherical side wall is received within a tubular organ, and tensile sutures extend through the implant ball for applying a tensile force to facilitate elongation of the tubular organ.

Abstract: An apparatus and method is provided for accessing an abdominal cavity of a patient via the anus for any number of surgical operations, e.g., colon cancer, appendectomy, lymph node biopsy, etc. The apparatus includes a tubular body that extends to an open end having a plurality of holes. The tubular body is inserted into the intestine of the patient, and a clamp is inserted through the tubular body of the apparatus and into the intestine. The clamp and the attached intestine is then pulled into the tubular body, so that the intestine can then be cut. The clamp and the adjacent intestine are then moved out of the tubular body so that the surgery may be performed through the intestine. The cut ends of the intestine can then be reattached (e.g., stapled, sutured, etc.) following completion of the surgery.

Abstract: An apparatus for the treatment of acid reflux disease comprising two or more movement restriction device segments adapted to be movement restriction device of a controlled size. The movement restriction device can at least partly be invaginated by a patient's stomach fundus wall. A substantial part of the outer surface of the movement restriction device is adapted to rest against the stomach wall without injuring the latter in a position between the patient's diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax, so as to maintain the supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen.

Abstract: The invention provides systems, devices, and methods for the delivery, deployment, and positioning of magnetic compression devices at a desired site so as to improve the accuracy of anastomoses creation between tissues, organs, or the like.

Abstract: A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.

Abstract: A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.

Abstract: A suprapyloric anchor assembly includes an antral cap having at least three stabilizing members configured to reside in an antrum and engage tissue circumscribing a pyloric valve. A duodenal member is configured to reside at least partially in a duodenal bulb, and one or more tethers connect the antral cap to the duodenal member. The tether(s) is/are configured to allow passage of stomach contents through the pyloric valve. Optionally, one or more gastric balloon(s) may attached to the suprapyloric anchor and be inflated with the gastric cavity.

Abstract: A surgical stapler is provided. The stapler employs circumferential channels through which staples are deployed along an arc pathway against an anvil surface. The curved channels allow staples with relatively longer legs to be used in the stapler having a smaller diameter at the jaws. Also, by utilizing a curved path, a much larger staple can be placed in the same diameter device. Specialized curved staples for use with the stapler of the present invention are also provided. To further enable the benefits of the stapler with circumferential channels and method of staple deployment, novel jaw reinforcement structures are provided in the present invention. The jaw reinforcement structures are located towards the center or bladeline of the device instead of around the circumference as in conventional staplers, thereby clearing the outer area near the circumference of the device to provide room for longer staples and staple firing components.

Abstract: A surgical device including a handle assembly, an elongated portion, and outer band assembly, and inner band assembly, a trocar assembly, and a seal assembly is disclosed. At least a portion of the outer band assembly is disposed radially within the outer sleeve. At least a portion of the trocar assembly is disposed radially within the inner band assembly. The seal assembly includes a first annular seal and a second annular seal. The first annular seal is disposed radially inward of the outer sleeve and radially outward of the outer band assembly. The second annular seal is disposed radially inward of the outer band assembly and radially outward of the inner band assembly.

Abstract: A magnetic vascular anastomosis device for rapid liver transplantation includes a magnetic ring assembly and a base member assembly. The magnetic ring assembly includes an O-shaped magnetic ring and a C-shaped magnetic ring coupled at a donor liver blood vessel and a receptor liver blood vessel respectively. The base member assembly includes an O-shaped base member and a C-shaped base member. The base member is categorized into a slotted base member, a columned base member, and a hooked base member for different surgical suture methods. The magnetic vascular anastomosis device incorporates with the magnetic attraction between magnetic rings, such that the entire liver transplantation vascular anastomosis process is fast, safe, and reliable. The vascular anastomosis device is able apply for different operations involving vascular anastomosis such as kidney transplantation, lung transplantation, heart transplantation, and maxillofacial surgery.

Abstract: Medical devices including vascular access kits and related system and methods are disclosed. In some embodiments, a vascular access system may include a first conduit, a second conduit, and an expandable stent that is coupled to both the first and second conduits such that there is a continuous lumen between the first conduit and the second conduit. Methods of deploying the vascular access system within the body of a mammal, more particularly, a human patient are disclosed. Methods of bypassing a section of vasculature of a mammal, more particularly, a human patient are disclosed. The vascular access system, when implanted and assembled, may be a fully subcutaneous surgical implant.

Abstract: Systems and methods for forming an anastomosis between two adjacent walls of a digestive tract are provided. The system can include a first and second magnetic implants that are configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period. The system can also include a retention member that can extend outwardly from a corresponding one of the first and second magnetic implants, the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period.

Abstract: An apparatus and method is provided for accessing an abdominal cavity of a patient via the anus for any number of surgical operations, e.g., colon cancer, appendectomy, lymph node biopsy, etc. The apparatus includes a tubular body that extends to an open end having a plurality of holes. The tubular body is inserted into the intestine of the patient, and a clamp is inserted through the tubular body of the apparatus and into the intestine. The clamp and the attached intestine is then pulled into the tubular body, so that the intestine can then be cut. The clamp and the adjacent intestine are then moved out of the tubular body so that the surgery may be performed through the intestine. The cut ends of the intestine can then be reattached (e.g., stapled, sutured, etc.) following completion of the surgery.

Abstract: A circular stapling device includes an elongate body having a flexible outer tube that supports a reload assembly, a flexible inner cable that supports an anvil assembly, and a flexible central tube that is supported about the inner cable and within the outer tube. The stapling device is configured to access body cavities which cannot be easily accessed by a circular stapling device having a rigid shaft.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Abstract: A system is disclosed. The system includes a reservoir for containing a fluidic medium, the reservoir including a front surface, a resilient cylindrical flexure portion connected to the front surface, the resilient cylindrical flexure portion comprising an accordion-like structure that is able to expand and contract to change an interior volume within the resilient cylindrical flexure portion, a central passageway within the resilient cylindrical flexure, and a collection chamber connected to the central passageway. Also, a system including a reservoir, a plunger head located within the reservoir, a plunger arm connected to the plunger head, a driving shaft connected to the plunger arm, and a motor connected to the driving shaft, the motor controllable to move the drive shaft in a first motion and a second motion so as to move the advance plunger head and retract the plunger head within the reservoir.

Abstract: The disclosed technology provides a device for sealing an aperture in a tissue of a body lumen. The device comprises a flexible support member having a base having (i) a central portion and (ii) one or more lateral support portions, to engage and/or hold a sealable member of the device against an interior surface of the tissue when the device is in the sealing position. The lateral support portions provide additional support surfaces to engage peripheral portions of the sealable member against the interior surface of the tissue.

Abstract: An assembly including a bougie and a sheath for use in performing a gastroplasty for dividing a stomach of a patient into a sleeve receiving food and a bypass portion. The bougie includes an elongated body having a segment being shaped to follow a lesser curve of the stomach, and an extension member being movable within the stomach for positioning a distal portion thereof away from a gastroesophageal junction of the stomach and to define a fluid passage between the sleeve and the bypass portion. The sheath has an elongated main lumen in which the bougie is inserted and the sheath is translatable along the bougie to selectively expose the extension member of the bougie to perform its guiding action, or hide the extension member to ensure secure displacement of the bougie within the stomach and along the oesophagus.

Abstract: Methods, devices, and systems are provided herein for loading a band ligation barrel onto a surgical instrument. For example, a surgical system is provided for loading a band ligation barrel onto a surgical instrument that has a loading tube with a lumen to receive one or more band deployment cords of a band ligation barrel. The loading tube can be inserted through a first lumen of a surgical instrument. The system can also have a loading cap that receives a distal end of the loading tube, and a distal portion of the loading cap can be inserted into a distal-most opening of the band ligation barrel to secure band deployment cords therein. The system can also have a loading key that can be inserted into a second lumen of the surgical instrument, and a distal end of the loading key can engage with a proximal end of the loading tube.

Abstract: Vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. A combination of the body's own natural mechanism with chemical and/or biological agents is relied upon to accelerate the hemostatic process. Included are steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A sealing member disposed proximal the expansible member is then displaced by retracting and tensioning a coil spring so as to expose a chemical and/or biological region or release region of the device. The retraction and tensioning of the coil spring is limited by a coupling member. Exposure of blood and tissue to the chemical and/or biological sealing member promotes the clotting processing to accelerate the occlusion process in the tract.

Abstract: A wound closure assembly includes an insertion tool having a proximal end and a distal section, such as a curved distal section, having a penetrating tip and first and second notches that are formed on opposite sides of the distal section. The assembly includes a tissue anchor having a hollow body and an insertion tool channel extending through the hollow body. First and second spaced tips project distally from the distal end of the hollow body and oppose one another on opposite sides of the insertion tool channel. The distal section of the insertion tool is inserted into the insertion tool channel of the tissue anchor so that the penetrating tip is distal to the first and second spaced tips, with the first and second spaced tips nested within the first and second notches for generating a releasable interference fit between the tissue anchor and the insertion tool.

Abstract: An esophageal atresia bridge device including a proximal anchor, a distal anchor, and a brace extending between the proximal anchor and the distal anchor. The brace permits the proximal anchor to move toward the distal anchor to apply a controlled tension that pulls the esophagus together and stretches the esophagus over time.

Abstract: An apparatus for providing dialysis is described. The apparatus is a patch which provides structural support to a blood vessel, such as vein or fistula. The patch provides a location for puncturing the blood vessel with a needle, either at the puncture site or on the back side to prevent the needle from going through the blood vessel. The patch may also be palpated, allowing health care provider to easily locate a preferred puncture site.

Abstract: Medical devices including vascular access kits and methods of using the kit are disclosed. In some embodiments, a conduit is measured using an outside diameter measurement apparatus to determine if the conduit is compatible with a connector such that there is a continual lumen between the conduit and the connector. In some embodiments, various outside diameter measurement devices and the methods of their use are disclosed. In some embodiments, the methods of connecting a conduit, and in some embodiments a strain relief structure, to a connector are described.

Abstract: A joining method for a medical device, in particular a surgical instrument or implant, with a shaft and an attachment to be secured on the shaft, the method having the following steps: heating the attachment or cooling the shaft, such that an internal diameter of an opening of the heated attachment is greater than an external diameter of the shaft, then placing the shaft into the opening of the attachment, and then cooling the attachment, so as to shrink the attachment onto the shaft in a manner substantially free of gaps, or heating the shaft, such that the shaft and the opening are connected by an interference fit. A corresponding medical device is produced by the joining method.

Abstract: A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.

Abstract: The present disclosure provides modular magnetic anastomosis devices that can be implemented in digestive surgery or in any circumstance of anastomosis between adjacent organs or two hollow viscera. The device is minimally invasive and easily and quickly delivered using laparoscopic or endoscopic procedures.

Abstract: A medical device and a system including same are provided. The medical device includes an elongated device body, at least a portion of which is steerable within a body of a subject via at least one control wire; and a plurality of control wire guides disposed along the elongated device body and being deployable to deflect the at least one control wire away from a longitudinal axis of the elongated device body.

Abstract: A system for endoscopically forming an anastomosis between two naturally adjacent points in the digestive tract. The system utilizes elongate magnetic devices that, when connected across a tissue boundary, necrose tissue until an anastomosis forms and the devices are passed naturally. Despite the elongate shape of the devices, the resulting anastomosis is substantially round. As such, round anastomoses can be formed having increased diameters merely by increasing the lengths of the devices, obviating the need for wider endoscopes.

Abstract: A shunt device for creating a shunt in an atrial septum includes magnets coupled to inner loops of a coil comprising at least two inner loops and two outer loops, with a diameter of each of the inner loops being less than a diameter of the outer loops. The coil is made of a shape memory alloy (SMA) and is adapted to exert a compressive force upon layers of tissue caught between the inner loops of the coil. The magnets are adapted to provide additional compressive force to adjacent inner loops of the coil, thereby further causing the coil to cut through the layers of tissue and create a shunt. The diameter of the resultant shunt is less than the diameter of the outer loops, thereby preventing the outer two loops from passing through the created shunt. At least one end of the coil has a connection means for connecting with a delivery device.

Abstract: Disclosed herein are systems and methods for insertion tools for implanting electrode leads. In one embodiment, an insertion tool comprises a shaft having an outer cannula and an inner cannula. An actuator may be configured to transition the insertion tool between at least three configurations. In a first configuration, the inner cannula and the outer cannula are configured to receive the lead in the shaft. In a second configuration, the inner cannula and the outer cannula are configured to secure the lead in the shaft. In a third configuration, the inner cannula and the outer cannula are configured to cause the lead to separate from the insertion tool and implant in adjacent tissue.

Abstract: A surgical simulator for surgical training is provided. The simulator includes a frame defining an enclosure and a simulated tissue model located inside the frame. The simulated tissue model is adapted for practicing a number of surgical procedures including but not limited to transanal excisions and transvaginal hysterectomies. Portions of the frame comprises a material adhesively compatible with the material of portions of the simulated tissue model to secure and suspend the simulated tissue model within the frame. The simulated tissue model may also include simulated vasculature configured to loop through apertures in the frame to secure and suspend the simulated tissue model within the frame.

Abstract: An implantable medical device for connecting tissue layers, such as connecting tubular tissues to create an anastomosis, includes a single elongate member and a covering material. The devices provided may also be used for other purposes including, but not limited to, partially or fully occluding openings in tissue, temporarily or permanently holding generally planar layers of tissue together, aneurysm repair, and the like.

Abstract: A device and method for performing anastomosis is described. In one embodiment according to the present invention, the device comprises a ring that has a plurality of pins extending from various locations on the ring. During a procedure, the pins are passed through portions of tissue and the ring is everted or radially flipped inside out to connect the tissues together.

Abstract: A catheter-based device tracks over a guidewire which has been placed from a first blood vessel into a second blood vessel. The distal tip of the catheter is advanced into the second vessel while a proximal member remains in the first vessel. Matching blunt tapered surfaces on each of the distal tip and the proximal member are clamped together, with adjacent walls of each vessel between them, after which a known, controlled pressure is applied between the two surfaces. Heat energy is then applied to the blunt surfaces for approximately 1-30 seconds to weld the walls of the two vessels together. After coaptation of the vessel walls, the heat is increased to then cut through the vessel walls to create a fistula of the desired size.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for facilitating anastomosis between bodily passages. In an illustrative embodiment, an eversion mechanism is configured to engage a first external surface of a receiving passage adjacent a first opening in the receiving passage in order to create a receiving flange presenting a first interior face. A donor support mechanism is configured to support a donor passage with an opening in an end in an everted position that forms a donor flange presenting a second interior face. The donor support mechanism is further configured to present the second interior face of the donor flange against the first interior face of the receiving flange to present a passage juncture. A suturing mechanism is configured to motivate a filament through a helical path around the passage juncture to suture the second interior face of the donor passage to the first interior face of the receiving passage.

Abstract: An apparatus for the treatment of acid reflux disease has an implantable movement restriction device adapted to be at least partly invaginated by a patient's stomach fundus wall. A substantial part of the outer surface of the movement restriction device is adapted to rest against the stomach wall without injuring the latter in a position between the patient's diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient's stomach the patient's diaphragm is restricted, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax, so as to maintain the supporting pressure against the patient's cardia sphincter muscle exerted from the patient's abdomen. The movement restriction device has a size of at least 125 mm3 and a circumference of at least 15 mm.

Abstract: The present invention relates to a device for endoscopy or endosonography-guided transluminal interventions whereby two luminal structures in the body may be drawn toward each other and a fluid conduit formed in between. The device may have a hollow central member to which is coupled a distal retention member and in one embodiment a proximal retention member. The retention members may each be positioned inside one of the luminal structures and expanded from a first condition to an expanded second condition having an increased radius. The length of the central member may be shortened and its diameter expanded to approximate the two retention members and thereby the luminal structures.

Abstract: Percutaneous access sheaths used to provide access to the vasculature and heart for the introduction of percutaneous ventricular assist devices (pVADs), and to remain in place for the duration of pVAD use. The sheaths include actively closeable seals engageable to seal against the drive lines of the pVADs to minimize blood loss during pVAD use.

Abstract: A medical device is disclosed, which is capable of treating lymphedema and reducing a reoccurrence rate after treatment. The medical device includes a tube member that includes a first end portion connected to a first body lumen L and a second end portion connected to a second body lumen P and a pressure-feeding unit that pressure-feeds a body fluid in the first body lumen to the second body lumen.

Abstract: Methods, apparatuses and systems are described for expandable stent delivery apparatus to cover an access site. The method may include delivering a stent delivery system through an access site, where the stent delivery system comprises a positioning member with a first portion that is rotatable with respect to a second portion, and where the stent is releasably coupled with the first portion of the positioning member. In some cases, the method may further include withdrawing an outer constrainment member from the stent to deploy a proximal portion of the stent within the body lumen and rotating the proximal portion of the stent away from the access site by withdrawing the positioning member proximally and back through the access site. The method may further include covering the access site with the proximal portion of the stent upon fully deploying the proximal portion from the outer constrainment member.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for facilitating surgical anastomosis. In an illustrative embodiment, an apparatus includes a first connector configured to engage an opening of a donor passage. A second connector is configured to engage an opening in a receiving passage. A separator is configured to support the first connector and the second connector and to fix relative positions of the end of the donor passage to edges of the opening in a receiving passage across a gap. The separator is configured to maintain the gap between the first connector and the second connector while multiple loops of a suture are passed through the edge of the opening in the donor passage and the edges of the opening in the receiving passage. The first connector, the second connector, and the separator are further configured to be removed from between adjacent loops of the multiple loops of the suture.