Abstract: Devices, systems, and methods of the present disclosure can overcome physical constraints associated with catheter introduction to facilitate the use of a catheter with a large distal portion as part of a medical procedure benefitting from such a large distal portion, such as, for example, cardiac ablation. More specifically, devices, systems, and methods of the present disclosure can compress an expandable tip of a catheter from an expanded state to a compressed state along a tapered surface of an insertion sleeve for advancement of the expandable tip into vasculature of a patient. The tapered surface of the insertion sleeve can, for example, apply compressive forces at an angle against the advancing expandable tip. As compared to other approaches to the application of compressive force to an expandable tip, compressing the expandable tip using an angled force can reduce the likelihood of unintended deformation of the expandable tip.

Abstract: A sheath includes: a ring-shaped inner layer structure, a ring-shaped outer layer structure and a frame structure, which can be radially expanded with the inflation of a balloon inside the inner layer structure. When the inner layer structure, the frame structure and the outer layer structure are not radially expanded, a radial dimension of an inner channel of the inner layer structure is at a first radial dimension, and the first radial dimension is greater than or equal to a radial dimension of the balloon that is not inflated. After the inner layer structure, the frame structure, and the outer layer structure are radially expanded, and the balloon is removed or deflated, the radial dimension of the inner channel of the inner layer structure is at a second radial dimension, and the second radial dimension is greater than the first radial dimension.

Abstract: Devices, systems, and methods of the present disclosure can overcome physical constraints associated with catheter introduction to facilitate the use of a catheter with a large distal portion as part of a medical procedure benefitting from such a large distal portion, such as, for example, cardiac ablation. More specifically, devices, systems, and methods of the present disclosure can compress an expandable tip of a catheter from an expanded state to a compressed state along a tapered surface of an insertion sleeve for advancement of the expandable tip into vasculature of a patient. The tapered surface of the insertion sleeve can, for example, apply compressive forces at an angle against the advancing expandable tip. As compared to other approaches to the application of compressive force to an expandable tip, compressing the expandable tip using an angled force can reduce the likelihood of unintended deformation of the expandable tip.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: An illuminating ring assembly is disclosed. The illuminating ring configured to be used with a surgical access element. The illuminating ring assembly comprises a housing defined by a cover and a wall member extending from the cover, wherein the cover and wall member cooperate to define a cavity therein, a light element configured to be disposed with the cavity, and an attachment mechanism configured to selectively attach the housing to a surgical access element. Wherein the cover and the light element both include an opening therethrough.

Abstract: A sterile closed intermittent urinary catheter system which is an easier to use by virtue of ergonomic shaping to facilitate advancement and retrieval of the catheter from the collection bag. The bag may have a closed internal hole adjacent an indent in one edge that creates a narrow channel through which the catheter passes. The narrow channel is located near to and in alignment with an outlet assembly so that the catheter extends from the narrow channel directly to the outlet. A user may easily grasp the catheter from outside the bag at the narrow channel and urge the catheter forward or backward to alternately extend and retract it through the outlet. A flexible pusher sleeve with gripper features may be added around the narrow channel to further facilitate catheter advancement.

Abstract: A sterile closed intermittent urinary catheter system which is an easier to use by virtue of ergonomic shaping to facilitate advancement and retrieval of the catheter from the collection bag. The bag may have a closed internal hole adjacent an indent in one edge that creates a narrow channel through which the catheter passes. The narrow channel is located near to and in alignment with an outlet assembly so that the catheter extends from the narrow channel directly to the outlet. A user may easily grasp the catheter from outside the bag at the narrow channel and urge the catheter forward or backward to alternately extend and retract it through the outlet. A flexible pusher sleeve with gripper features may be added around the narrow channel to further facilitate catheter advancement.

Abstract: A system for expanding a device in a conduit or orifice of a human body includes a balloon member that is movable from a first configuration to a second configuration. External surfaces of the balloon member can collectively have a non-cylindrical cross-section relative to a main axis of the balloon member, such that the external surfaces of the balloon member generally conform to the anatomical shape of the conduit or orifice when the balloon member is in the second configuration.

Abstract: Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.

Abstract: An optical penetrating adapter for mounting to a surgical portal to permit visualization through the surgical portal includes an adapter member defining a longitudinal axis and having a transparent window adapted to penetrate tissue and to permit visualization therethrough and means for coupling the adapter member to the surgical portal. The transparent window may have various shapes and configurations adapted to penetrate, dissect, resect or separate tissue in a non traumatic manner. Alternatively, the transparent window may incorporate structure such as cutting edges blades, points, etc to pierce, cut or incise tissue.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A stretchable-diameter inserter, for hemodynamic studies and related operations, is characterized in that it comprises an inserter tube, a hemostatic valve designed for preventing blood from exiting the patient toward the operator, a side line including a faucet, adapted to be used for performing blood taking and infusion operations and two dilatators: a first dilatator having a smaller cross-section and a second dilatator having a larger cross-section.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the anchor device can be installed using a technique in which the subcutaneous anchors undergo relatively little or no flexing when being inserted through the skin into the subcutaneous region between the skin and underlying muscle tissue which may be occupied by fatty tissue.

Abstract: A device and method for creating a connection with the left ventricle of a heart are provided. A seal member capable of moving between a folded position and an open position is attached to the end of a conduit. An introducer capable of moving between a first and second position allows for the expansion of the seal member into an open position. A clamp component is positioned outside of the heart to provide an axial clamping force with the wall of the heart so that a seal is created between the seal member and the wall of the heart.

Abstract: A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic or/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

Abstract: A dilating cannula includes a radially expandable flange and an expandable shaft. The radially expandable flange is disposed at a proximal end portion of the dilating cannula and includes two or more sectors that are each independently movable. The expandable shaft extends from the proximal end portion to a distal end portion of the dilating cannula and defines an inner passageway of the dilating cannula and includes two or more arms. A first branch of the two or more arms extends from one end of the base section and a second branch of the two or more arms extends from another end of the base section. The first branch is connected to a first sector of the two or more sectors of the radially expandable flange and the second branch is connected to a second, different sector of the two or more sectors of the radially expandable flange.

Abstract: The expandable sheath and system for intravascular insertion of a medical implement includes a cannula for entering a lumen of a vascular vessel of a patient, a guide wire insertable into the lumen, an introducer and dilator adapted to follow the guide wire into the lumen, an expandable sheath positioned on the introducer and dilator, with the expandable sheath being adapted to be positioned in the vessel, and an extension collar. The medical implement is received within the vessel by passing through the sheath upon separating the introducer and dilator therefrom. In one embodiment, a linear array of perforations formed through the expandable sheath allow for expansion. Alternatively, an external slit may be provided for selective expansion of the sheath.

Abstract: The expandable sheath and system for intravascular insertion of a medical implement includes a cannula for entering a lumen of a vascular vessel of a patient, a guide wire insertable into the lumen, an introducer and dilator adapted to follow the guide wire into the lumen, an expandable sheath positioned on the introducer and dilator, with the expandable sheath being adapted to be positioned in the vessel, and an extension collar. The medical implement is received within the vessel by passing through the sheath upon separating the introducer and dilator therefrom. In one embodiment, a linear array of perforations formed through the expandable sheath allow for expansion. Alternatively, an external slit may be provided for selective expansion of the sheath.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: The present invention relates to surgical access devices (or surgical access ports) and related methods. More particularly, the present invention relates to such devices that are advantageously adapted for use in single-incision laparoscopic surgical (“SILS”) procedures The present invention also relates to kits and methods involving such surgical access devices.

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: The present disclosure relates to a sheath system for enabling access through an opening in the body of a patient is provided. The sheath system includes a dilation assembly having a radially expandable tubular sheath defining a lumen having a first cross-sectional area when in a non-expanded condition, and a handle assembly operatively coupled to a proximal end of tubular sheath, the handle assembly defining an aperture formed therein, and a first thread defined on the handle in the aperture thereof. The sheath system further includes an expansion assembly including a tubular member defining a lumen having a second cross-sectional area which is larger than the first cross-sectional area of the tubular sheath of the dilation assembly and having an outer surface defining a second thread, the second thread being arranged for engaging the first thread.

Abstract: A catheter for the local delivery of therapeutic agents and methods of using the same for the treatment or prevention of disease are disclosed. A catheter may include a tubular net and a guidewire attached to the tubular net longitudinally along the abluminal side of the net. The catheter may further include a tubular member that opens onto the abluminal side of the tubular net.

Abstract: Embodiments may include an expandable access system having contracted and expanded configurations. The system and methods may include an expandable access device having a helix or wrapped shape. Embodiments may include a cannula, stent, needle, trocar, introducer, fastener, and/or any other devices disclosed herein. Embodiments may also include an expandable trocar positionable in at least a portion of the access device. A sleeve or band may be disposed over at least a portion of the access device and configured to resist radial expansion of the access device. Expansion of the trocar and/or receipt of an object may radially expand the access device between a contracted configuration and an expanded configuration.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

Abstract: A surgical access port for insertion into a body cavity can have an elongate tubular body extending along an axis between a proximal end and a distal end, and a tip at the distal end of the tubular body for penetrating through a body wall and into the body cavity. The distal tip moves from a first, penetrating position to a second, retaining position when the body wall has been traversed. The surgical access port may further comprise a seal housing connected to the proximal end of the tubular body, the seal housing having an access port providing an opening into the tubular body to allow passage of surgical instruments. The distal tip may be sharp, pointed or bladed. The distal tip may also be substantially blunt or have a conical surface. The access port may further comprise a retention member for connecting the tubular body and the distal tip.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The needle can include an elongated needle body and a hub from which the needle body extends. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The sheath can include a tubular sheath body disposed on the dilator and a sheath hub coupled with the tubular sheath body. The tubular sheath body can include a material that exhibits a reduced rigidity upon exposure to heat.

Abstract: An angioplasty procedure wherein a balloon dilatation catheter is movably positioned within an anchoring catheter and which in turn is located within a guiding catheter or wherein a balloon dilatation catheter is movably positioned within a guiding catheter and the anchoring catheter in turn is positioned on the external surface of the guiding catheter, or wherein a balloon dilatation catheter is movably positioned within a catheter which serves both as a guiding catheter and anchoring catheter. Additionally, valve elements are attached to the guiding and anchoring catheters to provide points of securement between the catheters and the balloon dilatation catheter and to prevent the backflow of blood through the catheter assembly. Actuation of the valve elements allows a doctor to control the movement of the catheters.

Abstract: A method of forming and enlarging a percutaneous penetration is provided. The method includes the step of providing a radially expandable dilation assembly having a needle assembly removably inserted in a axial lumen thereof. The radially expandable dilation assembly includes a radially expandable sleeve body defining a lumen and an introducer seal disposed across the lumen and defining an opening formed therein. The method further includes the steps of penetrating the radially expandable dilation assembly and needle assembly through tissue to a target surgical site, withdrawing the needle assembly from the radially expandable dilation assembly, and inserting an expansion assembly through the opening formed in the introducer seal and into the axial lumen of the radially expandable dilation assembly.

Abstract: Some embodiments of a medical device anchor system include an anchor sleeve that receives a catheter (or other medical instrument) though a working channel of the anchor sleeve. The anchor sleeve may include a first actuator that controls the extension of one or more subcutaneous tines into the subcutaneous region under the skin. The anchor sleeve can also include a second actuator that can cause the anchor sleeve to lock onto an outer portion of the catheter (or other medical instrument) arrange in the working channel.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: A medical instrument has a cannula and a seal disposed in the cannula. An expansion device serves for expanding an opening in the seal for guiding shafts of other instruments of greater diameter in a sealed manner through the expanded opening. The expansion device has an expansion cone with a plurality of slats mounted pivotably on an annular body at a first end thereof, a second end of the slats being connected to the seal in an area of the opening. The slats are connected at its first ends to the annular body via spherical heads engaged into corresponding openings in the annular body.

Abstract: A safety trocar assembly incorporating an airbag is provided to prevent overpenetration of the safety trocar assembly through an abdominal wall and into a body cavity. The safety trocar assembly includes an airbag cannula having an expandable airbag proximal of the distal end of the cannula. A sensing device is located at a distal end of the cannula for detecting changes in conditions at the distal end of the cannula. A trigger mechanism is provided on the cannula and operates to inflate the airbag in response to a change in condition detected by the sensing device.

Abstract: A method including positioning a catheter at a location in a blood vessel; imaging a thickness of a portion of a wall of the blood vessel at the location; identifying a treatment site; advancing a needle a distance into the wall of the blood vessel to the treatment site; and introducing a treatment agent through the needle to the treatment site. A composition including an inflammation-inducing agent and a carrier in the form of microspheres having a particle size suitable for transvascular delivery. A composition including a therapeutic angiogenesis promoter in a carrier and an opsonin-inhibitor coupled to the carrier. An apparatus for delivery of a therapeutic angiogenesis promoter.

Abstract: Medical devices and related methods are disclosed for delivering an implant into the body of a patient. The devices include a damping assembly having an internal chamber with a varying inner diameter, and a piston slideably disposed therein. The piston is operably connected with a catheter portion such that movement of the piston is associated with concurrent movement of the catheter for implant delivery. The varying inner diameter of the damping assembly results in a decrease in damping force during implant delivery, thus providing a substantially constant velocity of implant delivery.

Abstract: A medical catheter assembly includes a catheter hub, an elongate catheter member extending from the catheter hub and having at least one longitudinal lumen for passage of fluids, an extension tube extending from the catheter hub and defining an internal lumen in fluid communication with the at least one longitudinal lumen of the catheter member and a clamp positionable about the extension tube. The catheter hub defines a reduced profile to facilitate passage of the catheter hub through a surgical tunnel. The clamp includes first and second clamp sections and defines a longitudinal clamp axis. The clamp has a longitudinal opening for passage of the extension tube and a movable member adapted to move from a first position to a second position to substantially close the internal lumen. The first and second clamp sections are separable to facilitate transverse positioning of the clamp sections about the extension tube.

Abstract: The disclosure provides a catheter for positioning in a contralateral femoral approach in highly angulated iliac bifurcations. The catheter comprises an elongate shaft, an adjustable element, and a wire entrance port on the elongate shaft. The elongate shaft has a proximal portion, an intermediate portion, a curved portion, and a distal portion. The curved portion connects the intermediate portion and the distal portion. The adjustable element is configured to encompass the distal portion and the intermediate portion together in a closed position. The adjustable element can be removed away from the distal portion permitting the distal portion in an open position. The wire entrance port is disposed in the intermediate portion near the curved portion. The distal portion is biased to be spaced away from the intermediate portion in the open position. The adjustable element is connected to an operating wire configured to advance and retreat through the wire entrance port.

Abstract: Methods, systems and devices are provided for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. The occlusal stents are delivered with the use of an occlusal stent delivery system which is loaded with the occlusal stent with the use of an occlusal stent loading system.

Abstract: Vascular introducer systems, kits, and methods providing or creating access to vessels, such as radial or femoral arteries, are disclosed. A vascular introducer system includes a removable inner tubular member, a removable outer tubular, tear-away member, and an expandable passage member positioned between the inner and outer tubular members. The removable inner tubular member and the removable outer tubular, tear-away member help protect and maintain a contracted configuration of the expandable passage member when the introducer system is advanced into a vessel. The expandable passage member includes an inner surface configured to receive an elongate treatment device, for example, following removal of the inner and outer tubular members. In some examples, the expandable passage member includes one or more kink-resistant members extending along a portion of the passage member.

Abstract: An access needle well-suited for percutaneous implantation in a body lumen, such as the stomach or the jejunum. In one embodiment, the access needle comprises a cannula, a needle, a retractable stopper and a spreader. The cannula is a tubular member having a proximal end, a distal end, a lumen and a pair of side windows providing access to the lumen. The needle is slidably mounted within the cannula lumen and comprises a needle stem and a needle handle, the needle stem having a proximal end, a distal end and a longitudinal lumen, the needle handle extending outwardly from the needle stem proximate to the proximal end thereof. The stopper is coupled to the needle stem for translational movement, the stopper comprising a pair of outwardly-biasing wings removably insertable through the side windows for engaging an interior surface of a patient. The spreader is mounted within the cannula and spreads the wings outwardly as the wings are inserted out the side windows.

Abstract: A device and method for creating a connection with the left ventricle of a heart are provided. A seal member capable of moving between a folded position and an open position is attached to the end of a conduit. An introducer capable of moving between a first and second position allows for the expansion of the seal member into an open position. A clamp component is positioned outside of the heart to provide an axial clamping force with the wall of the heart so that a seal is created between the seal member and the wall of the heart.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the anchor device can be installed using a technique in which the subcutaneous anchors undergo relatively little or no flexing when being inserted through the skin into the subcutaneous region between the skin and underlying muscle tissue which may be occupied by fatty tissue.

Abstract: An introducer sheath includes a tubular body portion having a proximal region and a distal region, and defines an internal lumen configured and dimensioned to slidably receive a catheter. A penetrating portion at a distal end of the tubular body has a first tapered configuration to enlarge an opening in a body tissue during distal advancement of the introducer sheath through the body tissue and a second expanded configuration to enable the passage of a distal end portion of a catheter through the penetrating portion.

Abstract: In at least one embodiment of the present invention, an introducer for use in inserting a medical device into a body vessel of a patient is provided. The introducer comprises a housing having a proximal opening, a distal opening and a chamber extending therebetween. A seal in diaphragm form is disposed in the chamber. The seal is formed of polymeric material having a first phase transition temperature higher than about body temperature and a second phase transition temperature that is less than the first phase transition temperature but is greater than about room temperature. The seal is in a first configuration and has an opening formed therethrough when at about room temperature for advancing the medical device through the seal. The seal self-configures to a second configuration when at a temperature of at least the second phase transition temperature for obstructing the body fluid from flowing through the opening of the seal.

Abstract: A safety trocar assembly incorporating an airbag is provided to prevent overpenetration of the safety trocar assembly through an abdominal wall and into a body cavity. The safety trocar assembly includes an airbag cannula having an expandable airbag proximal of the distal end of the cannula. A sensing device is located at a distal end of the cannula for detecting changes in conditions at the distal end of the cannula. A trigger mechanism is provided on the cannula and operates to inflate the airbag in response to a change in condition detected by the sensing device.