Abstract: A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

Abstract: A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending outwardly through a stomach wall for coupling with a gas source for selectively inflating the balloon, to occlude at least a portion of the volume of the stomach cavity. The gastro-occlusive device may be employed in combination with a feeding tube unit, a drain unit or other ancillary apparatus, and is useful for treatment of morbid obesity and various eating disorders.

Abstract: A mounting structure for installation at a corporeal port opening. The mounting structure includes a reentrant tube on an exterior surface of which is disposed at least one balloon, with a proximal everted portion of the tubing extending from the distal portion of the tubing, with a gas flow passage associated with the tubing, for selective inflation of the balloon. A vacuum thermoforming process for making such mounting structure is described. The mounting structure is useful employed for anchoring of a therapeutic device such as an ostomy bag at a corresponding port of the body, with the balloon(s) of the device providing effective anchoring of the mounting structure and permitting the mounting structure to be comfortably worn by a patient during therapeutic intervention.

Abstract: A mounting structure for installation at a corporeal port opening. The mounting structure includes mounting structure for installation at a corporeal port opening, such mounting structure including a blowmolded article comprising enlarged cylindrical sections interconnected by tube segments, adapted to engage the corporeal port opening at a tube segment intermediate the enlarged cylindrical sections and with the enlarged cylindrical sections being in abutting contact with internal and external corporeal surfaces surrounding said port opening. The mounting structure is useful employed for anchoring of a therapeutic device such as an ostomy bag at a corresponding port of the body, with the enlarged sections of the device providing effective anchoring of the mounting structure and permitting the mounting structure to be comfortably worn by a patient during therapeutic intervention.

Abstract: A multi-lumen lay-flat tube formed of polymeric film material, e.g., polyurethane elastomer film, comprising a main tube and at least one interior tubular passage, wherein each of the at least one interior tubular passage is constituted by reentrant portions of polymeric film material forming the main tube. The multi-lumen lay-flat tube can be utilized for fabrication of a balloon catheter, or other indwelling catheter device. The multi-lumen lay-flat tube can be formed by a fabrication method including provision of superposed sheets of polymeric film material, welding the superposed sheets of polymeric film material along generally parallel, spaced-apart seam lines to form at least two passages bounded by a successive pair of such seam lines, and if desired everting the welded superposed sheets to form a main tube having at least one tubular passage therewithin.

Abstract: A speculum cover that is adapted to sheath the blades of a speculum, and to support lateral vaginal walls to facilitate vaginal/cervical examination during gynecological exams and surgery. The speculum cover includes top and bottom pockets for the respective blades of the speculum, and side portions having openings therein for sampling of tissue at the vaginal locus. In a specific implementation, the speculum cover is of a four-ply construction, formed by impulse welding or other polymeric film joining technique, and the two inner plies of the cover include rearwardly extending flaps to which are adhesively secured donning guide members for facilitating installation of the cover on the speculum.

Abstract: A centrifuge tube that is compressively flattenable by manual force exerted on opposing surfaces thereof. The centrifuge tube is formed with integral hinge elements at opposing sides thereof. The centrifuge tube of such configuration may be employed as a component of a kit including one or more swab elements, for collection of specimens, forensic evidence, and the like. The swab element may be subjected to squeeze-out action by withdrawing the swab through the slot formed by compressive flattening of the tube, so that the amount of collected material transferred to the tube for subsequent centrifugation processing is maximized.

Abstract: A dual balloon catheter apparatus for controlling postpartum hemorrhage in uterine or vaginal cavities or hemorrhage in other body cavities, comprising: (1) a catheter having an inflation lumen and a deflation lumen; (2) a first inflatable balloon in fluid communication with the inflation lumen; and (3) a second inflatable balloon encompassing the first balloon and in fluid communication with the deflation lumen. A gaseous inflation medium can be introduced from an external gas source through the inflation lumen to inflate the first balloon, so as to apply a substantially even pressure along a substantial portion of an inner surface of a uterine cavity to reduce or eliminate bleeding along such inner surface. The second inflatable balloon functions to confine any gaseous inflation medium that escapes from the first balloon, due to leakage or rapture of such first balloon, and to discharge such escaped gaseous inflation medium through the deflation lumen.

Abstract: A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending outwardly through a stomach wall for coupling with a gas source for selectively inflating the balloon, to occlude at least a portion of the volume of the stomach cavity. The gastro-occlusive device may be employed in combination with a feeding tube unit, a drain unit or other ancillary apparatus, and is useful for treatment of morbid obesity and various eating disorders.

Abstract: A male urinary incontinence control device including a circumferentially continuous inflatable cuff having a plurality of inflatable passages therein, optionally reinforced by rigid members, that slips over the glans of the penis for positioning along the longitudinal axis of the penile shaft. Upon inflation, the cuff applies radially inwardly directed compressive force to the shaft of the penis with a concomitant restriction of the urethral passageway. The inflatable cuff in one embodiment includes an integrated hand pump for convenient inflation and deflation.

Abstract: A male urinary incontinence control device including a circumferentially continuous inflatable cuff having a plurality of inflatable passages therein, optionally reinforced by rigid members, that slips over the glans of the penis for positioning along the longitudinal axis of the penile shaft. Upon inflation, the cuff applies radially inwardly directed compressive force to the shaft of the penis with a concomitant restriction of the urethral passageway. The inflatable cuff in one embodiment includes an integrated hand pump for convenient inflation and deflation.

Abstract: An expandable polymeric medical article is formed by a novel dip-molding process, involving multiple dipping and rotational drying of liquid polymeric material layer at different pivotal positions. Preferably, the rotational drying is conducted so as to form an expandable polymeric medical article having a reverse thickness gradient in relation to the thickness gradient of conventional dip-molded polymeric medical articles. Specifically, the expandable polymeric medical article of the present invention has an expandable body member and a neck member, wherein such neck member has a wall thickness that is greater than that of the expandable body member, before any significant expansion of such body member.

Abstract: A low-pressure balloon, and method of forming same by the steps of: preheat a thin film of thermoplastic polymeric material to a sufficient temperature; forming two halves of the balloon on said thin film of thermoplastic polymeric material by vacuum suction; isolating the two halves of the balloon from said thin film of thermoplastic polymeric material; bonding the two halves together on their edges to form the low-pressure balloon by radio-frequency welding method; and inverting the low-pressure balloon from inside out to turn the rough bonded edge of the two halves into the interior side of the balloon.

Abstract: A balloon article, e.g., for an in vivo lumenal procedure, formed of a UV cross-linkable polyurethane material that is partially cross-linked to an extent providing a desired expansibility and/or compliant character to the balloon. The degree of cross-linking is selectively modified by the degree of UV exposure to which the balloon article is exposed, and/or the relative proportion of the cross-linking agent, to achieve corresponding product characteristics ranging from semi-compliant to non-compliant polyurethane film properties, including low creep/semi-compliant films.

Abstract: A low-pressure balloon, and method of forming same by the steps of: preheat a thin film of thermoplastic polymeric material to a sufficient temperature; forming two halves of the balloon on said thin film of thermoplastic polymeric material by vacuum suction; isolating the two halves of the balloon from said thin film of thermoplastic polymeric material; bonding the two halves together on their edges to form the low-pressure balloon by radio-frequency welding method; and inverting the low-pressure balloon from inside out to turn the rough bonded edge of the two halves into the interior side of the balloon.

Abstract: Disclosed is a polyimide coated shape memory material suitable for thermomechanical treatment to shape-set the material into the desired configuration and activate shape memory properties. The polyimide coating is subjected to a curing regime that imparts higher heat resistance in the polyimide coating to withstand the elevated temperatures required during the shape-setting treatment.

Abstract: A polymer coated porous product includes a first porous substrate and a polymer coating penetrating the porous substrate. The polymer coated porous product may optionally include a second porous substrate, and the polymer coating penetrates both the first and second porous substrate. A process and an apparatus for producing polymer coated porous substrate. The process includes overlaying a film of polymer material onto a porous substrate, heating the film of polymer material, and vacuum drawing the heated film of polymer material into the porous substrate. The apparatus includes an extruder, means for producing a film of polymer material over a porous substrate, means for heating the film of polymer material and at least one vacuum unit. The vacuum unit draws the film of polymer material into a porous substrate.

Abstract: A protective cover for an article such as a stethoscope, comprising a bag member of elongate form, closed at a first end and fully or partially open at a second, opposite end to form an enclosed volume for retention of the head and elongate connector body of a stethoscope. The two longitudinal sides of such bag member can be seamless; alternatively, such longitudinal sides can comprise two seam lines. The bag member is longitudinally, medially severable at an end portion that include the second, open end, to yield two free end segments for covering respective ear tubes of the stethoscope. The protective cover may further include retention means for positionally retaining the free end segments of the bag member in protective covering relationship to the ear tubes of the stethoscope, e.g., adhesive and/or compressive clips, or a transverse heat seal at marginal extremities of the free end segments.

Abstract: An inflatable structure comprising an inflation compartment defining an enclosed interior volume and an anti-reflux valve having an outlet end positioned in the interior volume. The anti-reflux valve includes an elongate inflation passage including opposedly facing film layers that are bonded to one another at their edges to form an interior gas flow channel. The elongate inflation passage is bonded to the inflatable compartment to form an opening for introduction of gas into the passage, for inflation of the inflation compartment, and arranged so that upon termination of gas flow into the interior volume, after pressure in the interior volume has been raised above exterior pressure on the inflatable compartment, gas pressure in the interior volume collapses the opposedly facing film layers against one another to form a seal against the interior volume gas pressure and maintain the inflation compartment in an inflated state.

Abstract: A pulmonarily sized bag formed of a non-latex material, including a bag body formed of panels of resin film material welded to one another along a weld line defining a seam of the bag body bounding an interior volume of the bag. The seam includes an interior seam portion in the interior volume, and an exterior seam portion at an exterior surface of the bag. One of the interior seam portion and exterior seam portion comprises free edges of the seam, and the other one of such seam portions is devoid of free edges. The bag is formable by various techniques, including radio frequency welding, impulse heating, solvent bonding, etc., and is usefully employed in a breathing circuit to obviate the necessity of using latex breathing bags.