Abstract: This invention relates to containers for the cryopreservation of mammalian cells and particularly for the long-term freezing of red blood cell. This invention also relates to methods of manufacturing such containers.

Abstract: A positive displacement ampule for storing a fluid therein and dispensing the fluid therefrom. The ampule includes an elongate vessel for storing the fluid having a large diameter base portion at one end thereof joined to a small diameter stem portion at the other end thereof, a piston disposed in the vessel at the base end thereof for forcing the fluid from the vessel, a fracture probe for fracturing the base end of the vessel and a needle for inserting into the fractured base end of the vessel and for piercing the piston such that one end of the needle protrudes outwardly from the vessel and the other end of the needle communicates with the fluid in the vessel. In this manner, the fluid is pumped from the vessel through the needle by pushing the piston in the direction of the fluid.

Abstract: Apparatus for fixing a fracture of a bone including an elongated body member having a proximal end and a distal end for insertion into the intramedullary canal of the bone; a tab member having at least one aperture to allow for passage of a screw for fastening of the tab member to the bone; and a bolt for selectively removably coupling the tab member to the proximal end of the body member. Preferably, the tab member is of a hollow cylindrical configuration and removably interlocking the first plate member to a second plate member. In another embodiment, the apparatus include a body member for insertion into a bone cavity, the body member having at least one aperture disposed in close proximity to its first end to allow for passage of a screw for fastening the body member to the bone.

Abstract: An electronically controlled syringe system for connection to a balloon catheter or other balloon-type member and for automatically monitoring, displaying and recording inflation data when the syringe system is used to inflate the balloon of the catheter or other balloon-type member. A syringe having a barrel and a syringe plunger is selectively operable to increase fluid pressure applied to the balloon catheter or other balloon member by sliding the plunger further into the barrel. Positive pressure applied to the balloon catheter or member is released by withdrawing the syringe plunger toward the rear of the barrel. A piezoresistive semiconductor transducer housed on the barrel of the syringe senses fluid pressure applied by the syringe.

Abstract: A retainer and method of producing a retainer which cooperates with either a magnetic or non-magnetic surgical drape to hold instruments during surgical operations. A rectangular tray includes a wall which extends from the periphery of a base portion. The polypropylene base portion is thermally bonded to a thermoplastic rubber retainer to sandwich magnetic elements therebetween. The magnetic elements are magnetically attracted to a magnetic drape and thereby secure the retainer in any orientation with respect to the drape. The method including vacuum forming a thermoplastic shell over a tray configured mold to sandwich a magnetic element between the thermoplastic shell and a retainer.

Abstract: A method and apparatus are described for cutting, drilling, ablating, fusing or altering dental tissues including enamel, dentine, bone, and cementium among others. Far infrared radiation of wavelengths between 2.5 and 3.2 microns are used to selectively affect dental tissue, where the radiation energy density determines whether cutting, fusing or other effects are produced. Either continuous wave or pulsed radiation can be used, a suitable IR source being an Erbium YSGG laser having an output wavelength of 2.79 microns. The exposed dental tissue is removed, fused, or otherwise affected without damage to the surrounding tissues depending on the duration of the exposure.

Abstract: An adjustable-resistance anti-siphon device for a cerebrospinal fluid shunt is provided. The device has a substantially rigid housing having an internal cavity which contains a first chamber and a second chamber, the first chamber having at least one flexible wall, an inlet port and an outlet port, the ports passing through apertures in the housing; the second chamber being gas-filled and being in pressure communication with at least a portion of the at least one flexible wall of the first chamber; and gas pressure control means connected to said gas-filled chamber whereby the pressure in said gas-filled chamber may be adjusted.

Abstract: A releasable coupling connector apparatus for catheter applications is provided wherein the connector is partially filled wtih anti-infective solution during manufacture and capped so that a patient or medical technician does not have the task of opening the fluid pathway and introducing the anti-infective solution at point of use into the connector apparatus. The connector apparatus being partially filled with anti-infective solution and capped during manufacture is further sterilized by Gamma radiation in order to eliminate any organism resistant to the anti-infective solution. The releasable coupling connector apparatus provides the first practical double seal connector means wherein a double seal connector defining dual sterilant liquid containing chambers for use with catheter applications and particularly with CAPD whereby sterilization is assuredly and easily achieved by an impaired, unskilled patient even under adverse conditions.

Abstract: A locking surgical tool handle system. The invention includes a surgical tool handle that has an elongated body portion with a pistol-type grip. The front end of the handle body has a tool retaining structure comprising a contoured engagement face and a movable tension bar with an engagement end. Projections on the engagement end of the tension bar fit within a receiving channel of a surgical tool, such as a broach or rasp. A locking mechanism is provided within the handle body, and is implemented with pivotable links attached to the tension bar. The locking mechanism has an unlocked position in which the engagement end of the tension bar is spaced away from the engagement face of the handle body, and an over-center locked position in which the engagement end of the tension bar is retracted toward the handle body. When the tool handle is placed in its locked position, the engagement end of the tension bar pulls an attached tool into tight contact with the engagement face of the handle body.

Abstract: A medical device particularly adapted for use with a blood collection tube including a nonlinear needle having first and second needle points wherein the first needle point is selectively protected by a movable protective shield and the second needle point is designed to pierce the stopper of an evacuated blood collection tube. The needle guard is movable axially along a portion of the nonlinear needle between a needle tip exposing retracted position and a needle covering locked extended position.

Abstract: A closure device for connection to a fluid container which has an opening for receiving the device. The closure device has a base section which may sealably cover the container opening. The base section has a spike receiving opening passing there through with at least one air vent on the base section which is spaced from the spike receiving opening. A hydrophobic air filter, is associated with the air vent. Adjoining the base section is an internal cover, which lies over the aperture, covering it and the base section. The internal cover has a pierceable portion which is in alignment with the spike receiving opening of the base section.

Abstract: A kit for effecting hemostatis of an organ comprises a mesh and a sack. The mesh is formed of semirigid, bioabsorbable material adapted to be generally conformingly disposed on at least the bleeding surface of an organ. The sack is made of flexible, elastic, air-impermeable material adapted to be elastically stretched over the mesh and over a substantial portion of the organ and then released to compress the organ portion and thereby decrease the flow of blood thereto. The sack further permits operative attachment of the undersurface thereof to a vacuum source so that portions of the organ may be pulled outwardly by the vacuum into the interstices of the underlying mesh to promote hemostasis.

Abstract: A method, device and system for providing a flow of oxygenated perfusion fluid (e.g. oxygenated whole blood) through a balloon angioplasty catheter to perfuse tissues which would normally be deprived of blood flow when the balloon of the angioplasty catheter is inflated. In accordance with the invention, an extracorporeal membrane oxygenation device is fluidly connected to the angioplasty catheter such that oxygenated fluid (e.g. oxygenated whole blood) may be passed through the catheter and caused to exit the catheter distal to the angioplasty balloon. The patient's own blood may be withdrawn, oxygenated by the extracorporeal membrane oxygenation device and subsequently reinfused through the angioplasty catheter. A dual-lumen introducer sheath may be employed for the dual function of a) facilitating insertion of the catheter and b) allowing withdrawal of blood for subsequent oxygenation and reinfusion through the angioplasty catheter.

Abstract: A method of preparing autologous plasma fibrin perioperatively to induce local hemostasis is disclosed. The autologous plasma fibrin is thereafter simultaneously expelled onto a treatment site along with a physiologically acceptable thrombin solution to effect hemostasis at the site. An apparatus for simultaneously expelling the contents of vessels which separately contain the autologous plasma fibrin and thrombin solutions, respectively, is also disclosed. A kit for obtaining a sample of blood, extracting plasma fibrin therefrom, as well as all necessary syringes, needles, reagents, and the inventive apparatus is also disclosed.

Abstract: A prophylactic device has a first band adapted to be worn around the waist of a human female and a second band connected to the first band and adapted to be worn between the buttocks of a human female such that the anus is covered by the second band. A genitalia shield connects the first band and the second band and covers the perineum of the human female. The genitalia shield portion includes a sheath having an open integral therewith. The sheath is stored in a retracted position in which its length is diminished by a plurality of folded pleats. Placement of a member against the opening of the sheath unfolds the pleats to orient the sheath in an extended position such that the sheath enters the vaginal opening and is oriented within the vagina. Removable tabs attached to the genitalia shield portion and oriented over both sides of the sheath retain lubricant and/or spermicide adjacent to the two sheath sides.

Abstract: A method and apparatus for treating patients suffering from glaucoma. A hollow needle is inserted into the eye and advanced across the anterior chamber until the tip punctures the opposite anterior chamber angle wall, exiting the eye under the conjunctiva. The excess pressure is acutely relieved by seepage of the aqueous fluid into the subconjunctival space. A stainless steel helix is ejected from the hollow needle and lodged in the puncture wound of the anterior chamber wall. Sealing the anterior chamber angle puncture wound by normal healing processes is thus prevented and excess pressure is relieved chronically by aqueous fluid seepage through the wound to the subconjunctival space. In a variation of the technique the needle is not passed through the anterior chamber, but the helix is delivered ab externo into the chamber angle.

Abstract: An implant for use in the treatment of glaucoma is disclosed wherein the implant comprises an elastomeric plate having a non-valved elastomeric drainage tube attached thereto. The plate is elliptical in shape and curved so as to conform to the curvature of the eye. The plate is inserted into the eye in an incision made in the Tenon's capsule and sutured to the sclera. The drainage tube is tunnelled through the Tenon's capsule and cornea and inserted into the anterior chamber, thus providing patent fluid communication between the anterior chamber and the elastomeric plate. The flexible structure of the plate allows the plate to be easily inserted, thus reducing the surgical procedure length. In addition, the pliable material minimizes th risk of damage and trauma to surrounding tissues in the insertion process.

Abstract: A twin-chamber syringe has a pyrogen-free sterile solvent in the chamber averted from the needle, and in the second chamber facing the needle a charge of activity-sensitive human protein, introduced and lyophilized in a single operation in the syringe, where it is stored, in a quantity necessary for therapeutically effective administration. The invention also relates to the filling of the syringe and the potential it offers for immediate use of activity-sensitive human proteins and for self-administration at home.

Abstract: One of the two confined volumes, for example the "supplying" one (2), is provided with a tubular perforating element (3) confined within a space closed by a diaphragm or perforable wall (503); the second confined volume (1) also has a perforable diaphragm (301); the surfaces of the two diaphragms (503, 301) directed towards the external environment are permanently bonded together after which the perforator (3) is manipulated from the outside so as to perforate the two diaphragms, placing in communication, via the tubular duct of the perforator, the confined environment of the supplying volume with that of the second volume.

Abstract: An implantable fluid flow control device is assembled in a process wherein a first base is provided having a snap-fit barbed connector which defines a fluid passageway and a spline offset from the barbed connector, and a second base having a connector receptacle which defines another passageway and a spline receiving slot. The barbed connector is inserted into the receptacle, and simultaneously the spline is slidably received within the spline receiving slot in a manner preventing tensile and torsional movement between the bases. The coupled bases are placed in a holding fixture, and brought into close proximity with a heated element to fuse the first and second bases together. A pair of housing bodies are placed over, respectively, the first and second bases such that the bases and the housing bodies cooperatively define a fluid flow path through the flow control device.