Abstract: The disclosure relates to natural oil-based petrolatum compositions and a method of making the same. The natural oil-based petrolatum composition includes the esterification product of: about 0.1 wt % to about 35 wt % a fatty acid dimer, about 5 wt % to about 30 wt % a C8 to C22 fatty acid, and about 65 wt % to about 95 wt % hydrogenated natural oil, wherein the natural based petrolatum product has an acid value of less than 25. Natural oil-based petrolatum compositions can be used in personal care products.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: The disclosure relates to natural oil-based petrolatum compositions and a method of making the same. The natural oil-based petrolatum composition includes the esterification product of: about 0.1 wt % to about 40 wt % a fatty acid dimer, about 99.9 wt % to about 60 wt % of one or more components selected from the group consisting of C1-C6 polyols, natural oils, fatty acids, and acyls glycerols, wherein the natural based petrolatum product has a cone penetration value of greater than 10 and a polydispersity index greater than 1.3. Natural oil-based petrolatum compositions can be used in personal care products.

Abstract: The disclosure relates to natural oil-based petrolatum compositions and a method of making the same. The natural oil-based petrolatum composition includes the esterification product of a pre-esterification mixture of: about 15 wt % to about 25 wt % a fatty acid dimer, about 15 wt % to about 25 wt % glycerin, and about 55 wt % to about 70 wt % hydrogenated natural oil, wherein the natural oil-based petrolatum product has an acid value of less than 5.0. Natural oil-based petrolatum compositions can be used in personal care products.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

Abstract: A hybrid lateral vein introducer which includes a conventional splittable hemostatic valve, which comprises two symmetrical wing extending from a splittable hub. A conventional splittable proximal sheath portion is coupled to and extends from the hub. The sheath portion is a conventional soft pliable sheath, which has limited torqueability, but adequate flexibility to be maneuvered in the cardiac vascular system. At a predetermined distance from the valve, the sheath is coupled to a reinforced sheath portion. Reinforced sheath portion is reinforced sufficiently to allow for good integrity and crush resistance while maintaining flexibility of the sheath portion. A proximal segment of the sheath portion is reinforced, but still splittable. Alternatively, the entire length of the sheath portion including the proximal segment and distal portions are rendered splittable.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: The invention includes a universal transvalvular insertion tool for providing a passage through a multiplicity of differently designed hemostatically valved introducers, each having a valve within a valved body coupled to a cardiac introducer. The tool includes a longitudinally rigid sheath having a lumen and for insertion through the valve of any one of the multiplicity of differently designed hemostatically valved introducers to provide a substantially obstruction free path for delivery of a lead or vascular device through the valve and valved body to the introducer, the sheath having a length selected to extend through the valve without substantial deformation of the lumen of the sheath. A mechanism is provided for separating the rigid sheath to allow removal from the lead or device without removal of the transvalvular insertion tool over either end of the lead or vascular device.

Abstract: An introducer sheath comprising a curved shape that follows the right sided vasculature when introduced through the right side subclavian vein and which stops far short of the coronary ostium in the right atrium. No attempt is made to access the coronary sinus through the sheath. The sheath establishes a fulcrum point on the upper lateral wall of the superior vena cava and comprises the ability to be removed from the implanted pacemaker lead without flipping the distal end of the sheath to cause a pull back of the pacemaker lead. The more proximal portions of the sheath extend through the superior vena cava and provide a force which biases the sheath against the lateral wall of the lower portion of the superior vena cava to establish a fulcrum or pivot point which positions the distal end of sheath at the desired location.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

Abstract: An adapter for an introducer comprises a medical device having a tubular port on a proximal end such as a splittable hemostatic valve. A tubular fitting is provided on a proximal end of the introducer. An elastomeric member is disposed between the port of the medical device and the tubular fitting of the introducer for providing a fluid tight and mechanically secure connection therebetween. The introducer and valve are manually connectable and reconnectable with each other while maintaining the fluid tight connection between them. A side port may communicate with the hemostatic valve, the side port having a controllable valve ending. In the preferred embodiment the introducer comprises a splittable introducer. In the illustrated embodiment the elastomeric member provides a slip fit between the medical device and the tubular fitting of the introducer. A tab extends from the tubular fitting of the introducer to facilitate manual manipulation of the tubular fitting.