Abstract: A fully assembled dual chamber prefillable syringe cylinder for the administration of two components having a syringe barrel which, in both its single cylinder and dual chamber cylinder embodiments, is connected to both a syringe head featuring a tip cap as well as to the finger grips and which is closed at its base by means of a moveable plunger with a plunger rod and into which an intermediate plunger is positioned with the intent of separating first and second chambers from each other and which features a bypass located in a first chamber, as well as to a method for the manufacture and filling of said fully assembled prefillable syringe.

Abstract: A drug delivery system includes first drug (110) and second diluent (182) syringe assemblies which are respectively pre-filled with a drug concentrate and a liquid diluent. The diluent syringe assembly is positionable in operative association within a sterility maintenance sleeve (150) of the first syringe assembly so that the assemblies are joined in fluid communication. This fluid transfer connection permits the diluent to be transferred from the second syringe assembly into a sterile mixing chamber defined by a reciprocable stopper (134) in the first syringe assembly. Thereafter, the second syringe assembly can be moved with respect to the barrel of the first syringe assembly so that the resulting mixture can be delivered for patient administration.

Abstract: In the method of applying screening or treatment fluid to the cervix, vagina, or other genital tissues, the steps include providing an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier; providing a fluid applicator at one end of the assembly to communicate with the interior of the outer container; providing a frangible inner container protectively located within the outer container, and providing screening or treatment fluid within the inner container, exerting pressure on the outer container sufficient to rupture the inner container, thereby releasing the screening or treatment fluid into the interior of the outer container, enabling fluid migration to the applicator, and manipulating said assembly to cause the applicator to apply screening or treatment fluid to the cervix, vagina, or other genital tissues.

Abstract: A transdermal introducer assembly is provided for quick and easy transcutaneous placement of a medical tube on a patient with reduced patient discomfort. The introducer assembly comprises a medical tube segment defining a hollow lumen extending between a distal end for placement into the subcutaneous tissue and a proximal end disposed outside the patient. The tube segment is assembled in side-by-side relation with a hollow introducer needle, and includes an elongated introducer thread at the distal end thereof folded back for slide-fit reception into the open distal end of the introducer needle. In use, the introducer needle is deployed to pierce the patient's skin at a selected placement site and to carry the tube segment to the desired transcutaneous position, after which the introducer needle can be withdrawn and slidably separated from the introducer thread to leave the tube segment and thread in place on the patient.

Abstract: Device for mixing a pharmaceutical composition stored in a chamber (44) in said device with an agent to be added shortly before administration to form a preparation to be adminstered. The device should be capable of being shaken without leaking. It comprises a hollow body (2) having an outlet (4) sealed by a removable closure (12) and a plunger (6), which is slidable therein in sealing contact with the inner wall of the hollow body (2). The plunger (6), the hollow body (2) and the removable closure (12) define said chamber (44). An actuating means (22) is connected to the plunger (6) for displacing the same in the hollow body (2). A filling conduit (19) for said agent is connected to the chamber (44). A check valve (30) is associated with the conduit (19) and the chamber (44), which prevents flow from the chamber (44) but permits flow into said chamber through said conduit (19).

Abstract: An injection cartridge is disclosed which has provision for the after injection of a rinsing solution to wash off the medicament that is first injected. The novel cartridge has a forward compartment and a rearward compartment, each having a piston disposed rearwardly thereof. A by-pass conduit is provided at the forward end of the cartridge which is longer than the thickness of the forwardmost piston. A medicament is positioned in the forward compartment and a rinsing solution is positioned in the rearward compartment. Moving the rearward piston forward forces the rinsing solution against the forward piston which in turn forces the medicament forward and expels it from the forward compartment. After the forward piston has reached its forward stop, the forward by-pass becomes open to the rearward compartment and continued forward movement of the rearward piston causes the rinsing solution to be forced through the forward by-pass and out the outlet end of the cartridge.

Abstract: An apparatus and method for use in performing ablation of organs and other tissue includes an electrode carrying member which is substantially absorbent and/or permeable to moisture. The electrode carrying member is mounted to the distal end of an elongate shaft, and an array of electrodes is mounted to the surface of the electrode carrying member. Following placement of the ablation device into contact with the tissue to be ablated, an RF generator is used to deliver RF energy to the electrodes and to thereby induce current flow from the electrodes to tissue to be ablated. As the current heats the tissue, moisture (such as water vapor or liquid) leaves the tissue causing the tissue to dehydrate. The moisture permeability and/or absorbency of the electrode carrying member allows the moisture to leave the ablation site so as to prevent the moisture from providing a path of conductivity for the current.

Abstract: A pharmaceutical packaging system is provided that includes a sealed envelope having a compartment containing a syringe and a second compartment for containing a medical material. A sealed portal is defined intermediate the two compartments. The sealed portal is sized and configured to receive a distal member of the syringe whereby liquid can be withdrawn from the second compartment into the syringe without being exposed to the ambient environment.

Abstract: The invention is an irrigating device having a rigid housing defining a canal containing a three way valve selecting between three ends where at least one of the three stems has an elastic attachment for receiving two separate non-elastic medical input devices sharing a common chamber which common chamber communicates with the rigid housing canal. It has at least one three-way valve directing the flow of suction or fluids to graduated openings in the medial, distal and proximal direction. The medial opening is where the elastic attachment is place which defines a plurality of tubes. All of these tubes may be elastic. All may have an inner circumference for receiving a tube or syringe of corresponding outer diameter. Alternatively, one of these tubes may be elastic having an outer diameter for insertion into a tube or syringe of corresponding inner diameter so as to form an elastic, but water tight seal.

Abstract: An apparatus for separately storing a medicament component, such as a drug and for mixing this component with a liquid component, such as a sterilized diluent, to form a beneficial agent which can be delivered to a patient from the container containing the liquid component. The device includes a novel collapsible vial structure which can be used for controllably introducing a support structure carrying the medicament component into the liquid container whereby the medicament and liquid components will thoroughly mix under sterile conditions.

Abstract: An applicator for dispensing a first and a second component of a biological adhesive, such as a fibrin sealant, wherein the applicator comprises a housing having a first dispensing conduit for dispensing the first component and a second dispensing conduit for dispensing the second component. A pressure supply conduit is in communication with the dispensing conduits and both a first reservoir containing the first component, and a second reservoir containing the second component. A first pressure regulator, also in communication with the first reservoir, controls the pressure supplied through the pressure supply conduit to the first reservoir and a second pressure regulator, also in communication with the second reservoir, controls the pressure supplied through the pressure supply conduit to the second reservoir.

Abstract: A balloon catheter (2) comprises an outer sheath (3) housing an inner catheter (10). The inner catheter comprises an inner tubular member (30), a braided reinforcement layer (32), and a soft outer layer (34). The inner tubular member extends from a proximal end (15) of the inner catheter to a first distal location (22). The braided reinforcement layer extends from the proximal end to a second distal location (18), usually located proximal of the first distal location. The soft outer layer extends from the proximal end of the inner catheter to the tip (44) of the inner catheter. In this way, a catheter having a shaft region (16), a transition region (20), and a distal region (24), each with different strength and flexibility characteristics, can be used with the outer sheath. The balloon (8) is bonded to the distal ends of the outer sheath and the inner catheter and is inflated through the space defined therebetween.

Abstract: The invention relates to a catheter comprising a tube-like basic body with a proximal and a distal end and an expandable balloon member arranged close to the distal end to the basic body. The balloon member comprises a number of relatively stiff sections extending on a small diameter in a longitudinal direction of the basic body and relatively pliable sections extending inbetween, wherein the relatively pliable sections form lobes in an expanded state of the balloon member. The invention furthermore relates to a method for manufacturing a catheter according to the invention, wherein a piece of tube-like basic material is provided and, by blow molding, a balloon member is made in a mold, which is arranged to the bias material. The balloon member is manufactured in the mold cavity of a mold, the cross-section of which is lobated, by receiving a tube-like partial manufacture inside it and deforming it by blow molding into a shape corresponding to that of the shape of the mold cavity.

Abstract: A mechanical prosthesis deployment device for enlarging a flow passage of a vessel by delivering and deploying an expandable stent or prosthesis within an obstruction in the vessel. The prosthesis deployment device comprises a cylindrically shaped expansion member adapted to be disposed within the expandable prosthesis and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration and a diametrically expanded configuration.The present method comprises the steps of advancing the expansion member to the obstruction in a vessel and applying opposed forces on said expansion member in an axial direction to move the expansion member to an expanded configuration wherein the expansion member exerts radial force on said prosthesis and said prosthesis is expanded and implanted into the vessel.

Abstract: A sheath introducer for a catheterization or similar procedure comprises a main body having an exterior tapered sidewall, an interior lumen, a beveled top surface and an annular boss extending from the top surface; a rotating section having an exterior sidewall, an interior lumen, a beveled bottom surface having a recessed portion dimensioned so as to be received within the main body annular boss, and a top surface having an annular shoulder extending therefrom creating a recess; a cannula extending from the bottom end of the main body; and, a hemostatic valve having an access port and a fluid tight slit opening and seated within the upper portion and maintained by a cap, the valve being maintained within the rotating section recess and preferably slightly compressed when the rotating section and main body are assembled. When assembled, the rotating section can rotate up to approximately 180.degree., affording approximately a 45.degree.

Abstract: Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricous and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Abstract: An implantable catheter defining a plurality of fluid exits responsive to a first range of pressure on a fluid agent for delivering substantially the same flow rate of the agent through each of the exits into spaced infusion sites and responsive to a second range of pressure less than a threshold pressure on the agent for inhibiting the flow of the agent from any of the exits into any of the sites. A first pressure in the first range is applied to the agent in the catheter for a first time period and a second pressure in the second range is applied for a second time period to the agent in the catheter so that substantially the same dosage of agent can be applied to each of the sites.

Abstract: A balloon dilatation catheter having a catheter shaft with an oblong transverse cross-section with one transverse dimension in a first direction being significantly larger than a second transverse dimension in a direction perpendicular to the first direction. The first dimension is about 1.1 to about 3 times greater, preferably about 1.2 to about 2.5 times greater than the second dimension. In one embodiment, a length of the distal shaft section has inner and outer tubular members where about 30% to not more than about 90% of the inner periphery of the outer tubular member takes the shape of and is secured to the exterior of the inner tubular member. In another embodiment the flexible distal shaft section is an extruded section having an oval or elliptical transverse cross-section. Preferably a pseudoelastic hypotube of NiTi alloy defines at least part of the inflation lumen within the catheter shaft.

Abstract: A portal assembly includes a port with at least one resealable septum, and a tube extending from the port with the tube being sized to be received inside a catheter, an angled surface surrounding the tube wherein the angled surface diverges away from the tube in a direction away from the port, and sleeve structure for forcing the end of the catheter into the angled surface, thereby forcing the end of the catheter radially inwardly toward the tube and forming a thickened portion adjacent the end of the catheter to seal and hold the catheter. In a dual port construction, the outlet tube are parallel to one another at their distal ends, and the sleeve structure forces the end of the catheter into the angled surface, thereby forcing the end of the catheter radially inwardly toward the tubes and forming a thickened portion adjacent the end of the catheter to seal and hold the catheter and to prevent cross-talk between lumens of a dual lumen catheter.

Abstract: A steerable catheter comprising a resilient body member, a manipulation handle attached to the proximal end of the body member, a control wire extending from the handle to the distal end of the catheter for deflection control, and a pulley mechanism for controlling the movement of the control wire. Longitudinal movement of a slide element in the handle causes movement of the control wire and control over the deflection of the distal end of the catheter. The pulley mechanism is connected between the slide element and the control wire to provide greater mechanical advantage to effect deflection of the body member while enhancing deflection control resolution. A stiffening member is also disposed in the catheter body member and its position is controlled by the rotational motion of the slide element. The position of the pulley mechanism is not affected by rotational motion of the slide element.