Abstract: There is provided a method for performing a tracheotomy. In this method a tracheostomy dilator has a body and a tip which are detachably attached. The tip has a proximal inner portion which is within the body while the tip is attached to the body. The dilator is inserted into the trachea and used to dilate an opening. After the trachea has been dilated, the body may be detached and removed from the tip, the tip remaining partially in the trachea. A dilator loading catheter installed within a tracheostomy tube may be mated with the tip and the tip, loading catheter and tracheostomy tube moved into the trachea. After the tracheostomy tube is installed, the tip and loading catheter may be withdrawn through the tracheostomy tube and the tracheostomy tube placed in service.

Abstract: There is provided a device for performing a tracheotomy. The tracheostomy dilator has a body and a tip which are detachably attached. The dilator has a cannula sized to accommodate a guiding catheter. The tip has a proximal inner portion which is within the body while the tip is attached to the body. After the trachea has been dilated, the body may be detached from the tip and removed and a tracheostomy tube may be inserted over the inner portion of the tip. The tip then may serve to guide a tracheostomy tube into the trachea. After the tracheostomy tube is installed, the tip and other components may be withdrawn through the tracheostomy tube and the tracheostomy tube placed in service.

Abstract: There is provided a novel tracheostomy tube flange. The flange is made of a flexible material and has a large open area for viewing of the underlying skin. The flange has holes for suturing the flange to the skin and slots for attachment of a strap to surround the neck and keep the flange and tube in place. The flange may swivel on the tube to allow for greater flexibility in attaching it to the skin. A stoma pad may be used with the flange to help keep the skin under the flange healthy.

Abstract: There is provided a device for removing a tracheotomy dilator. The dilator has a body and a tip which are detachably attached. After dilating the trachea, the body is removed, leaving only the tip in the tracheal opening. The dilator tip loading catheter has a distal end adapted to engage the proximal end of the dilator tip, a proximal handle, and a mid-section therebetween. The device also has a cannula therethrough. The proximal handle can detachably attach to the proximal end of the tracheostomy tube. The distal end and mid-section of the device are sized to fit into the cannula of a tracheostomy tube. The distal end and mid-section of the device may be inserted into a tracheostomy tube, the distal end then mating with the proximal end of the dilator tip. The entire assembly may be moved into the trachea. Once the trach tube is in position, the loading catheter and tip may be withdrawn through the trach tube.

Abstract: There is provided a tubular workpiece for blow-molding into an inflatable balloon component. The tubular workpiece is a raw tube having a lumen and composed of a thermoplastic polymer, the tube having an asymmetric wall thickness such that when the tube is preheated in a mold to a temperature sufficient to soften the material of the tube and inflated with a gas to generally uniformly stretch the material of the tube, the tube forms a balloon component. The balloon may be non-uniform in wall thickness depending on the type of mold used. The balloon may be attached according to conventional means to a hollow tube to produce a tracheostomy device.

Abstract: There is provided a device for performing an initial piercing and dilating of a patient's trachea. The device has a needle within and extending beyond a sheath. After the needle is used to pierce the trachea, it may be removed and a guide wire (J-wire) inserted. A introducer dilator surrounds the sheath and is slidable over the sheath. The introducer dilator has a first position away from the distal end of the sheath and a second position in which the distal end of the sheath is substantially covered by the introducer dilator. The introducer dilator is then used to expand the initial piercing.

Abstract: There is provided a moisture indicator for a heat and moisture exchange (HME) device that uses a pre-colorant and an activator applied to an inner surface of the HME device. The colorant undergoes a color change of Delta E (?E) of equal to or greater than 3 units upon exposure to moisture but not upon exposure to high humidity. The colorant is visually obvious to the unaided human eye under normal light conditions through the body of the device. The HME device with the visual indicator for moisture can indicate to the care-giver that it is time to change the HME device.

Abstract: A medical device assembly for imparting a lubricious and/or antimicrobial liquid onto a medical device is provided. The medical device is surrounded by a pouch and includes a burst package or frangible cells for storage of the liquid prior to delivery onto the surface of the medical device. This helps prevent contamination of the medical device upon removal of the medical device from its pouch, insertion of the device into a body cavity, and implantation of the device into the body cavity.

Abstract: There is provided a balloon cuffed tracheostomy tube with a balloon designed so as to enhance the tube's anchorability without sealing the tracheal stoma. The tracheostomy tube device includes a conventional curved hollow tube. The distal end of the tube is adapted for insertion through a tracheal stoma and into the tracheal lumen of a patient's throat. The device further includes an inflatable balloon enveloping a portion of the tube. The balloon has a distal portion substantially centered about and attached to the distal end portion of the tube. The balloon also has a proximal portion attached to the bend region of the tube and positioned substantially off-center relative to the proximal portion of the tube and about the bend region below the proximal plane of the device.

Abstract: There is provided a balloon cuffed tracheostomy tube with a balloon designed so as to enhance the tube's anchorability without sealing the tracheal stoma and to allow for an easier insertion into the trachea than a comparable tube with a thicker balloon. The tracheostomy tube device includes a conventional hollow tube having a proximal end portion, a distal end portion, and a bend region intermediate of the end portions. The distal end portion of the tube is arranged for insertion through a patient's throat and tracheal stoma and into the tracheal lumen. The device further includes an inflatable balloon enveloping a portion of the tube. More particularly, the balloon is equal to or less than 30 microns in thickness, allowing for a greater ease of insertion and insertion through a smaller stoma opening, than a comparable tube with a balloon having a thickness greater than 30 microns.

Abstract: A suture tester for evaluating fray resistance of surgical sutures. The suture tester comprises a reciprocating drive member, first, second, third and fourth pulleys, and a tensioning element. The pulleys each have a suture contact surface, which define a single plane. The third pulley is rotatable about this single plane. The first, second and third pulleys are all movable on the single plane. A suture is mounted in the suture tester such that one end is attached to the reciprocating drive member, it then passes to the first pulley, to the third pulley, to the second pulley and to the fourth pulley, before attaching to the tensioning element at the other end of the suture. The third pulley is then rotated and locked into place to form the desired number of suture wraps. The suture tester is started and causes the suture to rub against itself until it fails.