Abstract: A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device comprising an antioxidant selected from gallic acid or a derivative thereof. A second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes carboxymethyl cellulose or a derivative or salt thereof. The use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions, are also provided. The wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf-life of the wetted coated product.

Abstract: A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes an antioxidant selected from gallic acid or a derivative thereof. A second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes carboxymethyl cellulose or a derivative or salt thereof. The use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions, are also provided. The wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf-life of the wetted coated product.

Abstract: A catheter may include a tubular member having a lumen and an outer surface, a sleeve configured to be positioned in the lumen in a retracted configuration and to evert over at least a portion of the outer surface in an everted configuration, and a filament configured to retract the sleeve into the retracted configuration. The catheter may include an aperture proximal of a distal end, where the filament extends through the aperture from the lumen. A pull member may be on a distal end of the filament. The filament may be looped, coiled, and/or bunched in the catheter when the sleeve is in the retracted configuration. A shuttle may be attached to a distal end of the sleeve, where the shuttle includes a tubular member configured to maintain patency of the sleeve, and the filament engages the shuttle to retract the sleeve into the lumen.

Abstract: A method of making a ready-to-use catheter assembly is provided, which can be immediately used by a patient. The ready-to-use catheter assembly ensures that the catheter does not suffer from a loss of quality during its shelf life and a wetting medium are provided. The method comprises: placing a catheter with an inactivated hydrophilic outer surface at least along its insertable length and a wetting medium in a catheter package; treating the catheter package with the catheter and the wetting medium with electro-magnetic and/or particle radiation while at least initially the hydrophilic outer surface at least along the insertable length of the catheter remains inactivated; and activating the hydrophilic outer surface at least along the insertable length of the catheter with the wetting medium during and/or after the radiation treatment and wherein the wetting medium decreases in viscosity when submitted to electro-magnetic and/or particle radiation.

Abstract: A catheter may include a tubular member having a lumen and an outer surface, a sleeve configured to be positioned in the lumen in a retracted configuration and to evert over at least a portion of the outer surface in an everted configuration, and a filament configured to retract the sleeve into the retracted configuration. The catheter may include an aperture proximal of a distal end, where the filament extends through the aperture from the lumen. A pull member may be on a distal end of the filament. The filament may be looped, coiled, and/or bunched in the catheter when the sleeve is in the retracted configuration. A shuttle may be attached to a distal end of the sleeve, where the shuttle includes a tubular member configured to maintain patency of the sleeve, and the filament engages the shuttle to retract the sleeve into the lumen.

Abstract: A method of making a ready-to-use catheter assembly is provided, which can be immediately used by a patient. The ready-to-use catheter assembly ensures that the catheter does not suffer from a loss of quality during its shelf life and a wetting medium are provided. The method comprises: placing a catheter with an inactivated hydrophilic outer surface at least along its insertable length and a wetting medium in a catheter package; treating the catheter package with the catheter and the wetting medium with electro-magnetic and/or particle radiation while at least initially the hydrophilic outer surface at least along the insertable length of the catheter remains inactivated; and activating the hydrophilic outer surface at least along the insertable length of the catheter with the wetting medium during and/or after the radiation treatment and wherein the wetting medium decreases in viscosity when submitted to electro-magnetic and/or particle radiation.

Abstract: An intraosseous access device for accessing an intraosseous space of a patient includes a manual driver and a sternal locator. The handle is connected to an inner penetrator hub, and an inner penetrator extends from the inner penetrator hub. An outer penetrator hub is releasably engaged to the inner penetrator hub. A protective cover is slidably coupled to the handle. The protective cover is operable to move from an extended position where the inner penetrator is covered, to a retracted position where the inner penetrator is exposed. The sternal locator includes a base; a collar extending from a first surface of the base for securing the intraosseous access device to restrict longitudinal separation of the intraosseous access device from the locator. The locator may be removed from the patient while the outer penetrator remains inserted in an intraosseous space of the patient.

Abstract: An apparatus operable to provide access to a sternal intraosseous space in a first mode of operation and operable to provide access to a peripheral intraosseous space in a second mode of operation. The apparatus includes a manual driver and a stabilizer. The manual driver has a handle, an inner penetrator hub, and an outer penetrator hub. The stabilizer has a housing, an outer sleeve coupled to the housing and configured to move from an extended position to a retracted position in the first mode of operation, and a protective shield coupled to the stabilizer housing and configured to move from an exposed position to a shielded position in the first mode of operation. The manual driver is securely engaged to the stabilizer in the first mode of operation, and the manual driver is detached from the stabilizer in the second mode of operation.

Abstract: An intraosseous access device is operable to provide access to a sternal intraosseous space in a first mode of operation and operable to provide access to a peripheral intraosseous space in a second mode of operation. The device includes an outer sleeve, an inner penetrator hub, and an outer penetrator hub. A protective shield is telescopically coupled to the outer sleeve. The protective shield is operable to move from an expanded position to a retracted position in both the first and second modes of operation. A bone probe ring is disposed within the protective shield and configured to move between an extended position and a retracted position in both the first and second modes of operation. An actuator is operable to manually move the protective shield and the bone probe ring to the retracted position when in the second mode of operation.

Abstract: A catheter assembly may include a catheter member having a proximal portion and an outer surface; an introducer having a lumen configured to receive the proximal portion of the catheter member; and a sleeve having a compressed portion housed in the lumen of the introducer, the sleeve being configured to evert over the outer surface as the catheter member is inserted through the lumen of the introducer. The proximal portion of the catheter member may be configured to push a distal portion of the sleeve proximally, and the compressed portion of the sleeve may form a soft proximal tip of the catheter assembly as the catheter member exits a proximal opening of the introducer.

Abstract: A catheter (700) includes a tubular member (702) having a lumen and an outer surface, a sleeve (704) configured to be positioned in the lumen in a retracted configuration and to evert over at least a portion of the outer surface in an everted configuration, and a filament (700) configured to retract the sleeve (702) into the retracted configuration. The catheter includes an aperture (774) proximal of a distal end, where the filament (770) extends through the aperture (774) from the lumen. A pull member (772) may be on a distal end of the filament (770). The filament (770) may be looped, coiled, and/or bunched in the catheter (700) when the sleeve (704) is in the retracted configuration. A shuttle (718) may be attached to a distal end of the sleeve (704), where the shuttle (718) includes a tubular member configured to maintain patency of the sleeve (704), and the filament (770) engages the shuttle (718) to retract the sleeve (704) into the lumen.

Abstract: Manually driven intraosseous devices and associated methods are disclosed. The intraosseous device includes a housing and a transmission at least partially disposed within the housing. The transmission includes a first portion and a second portion. The second portion includes a manual actuator that is at least partially disposed outside of the housing. The intraosseous device also includes a penetrator assembly releasably connected to the first portion of the transmission. The transmission is configured to transmit a force, which is applied manually to the manual actuator, to the penetrator assembly to rotate the penetrator assembly relative to the housing and to drive the penetrator assembly through a bone into an intraosseous space. The manual actuator is a hand crank that is configured to be manually cranked by an operator to transfer rotational force to the first portion of the transmission.

Abstract: Manually driven intraosseous devices and associated methods are disclosed. The intraosseous device includes a housing and a transmission at least partially disposed within the housing. The transmission includes a first portion and a second portion. The second portion including a manual actuator that is at least partially disposed outside of the housing. The intraosseous device also includes a penetrator assembly releasably connected to the first portion of the transmission. The transmission is configured to transmit a force, which is applied manually to the manual actuator, to the penetrator assembly to rotate the penetrator assembly relative to the housing and to drive the penetrator assembly through a bone into an intraosseous space. The manual actuator is a pull chord and the force is configured to be applied by an operator to a first end of the pull chord to unwind the pull chord and transmit the force to the penetrator assembly.

Abstract: Penetrator assemblies operable to provide access to an intraosseous space are disclosed. The penetrator assembly may include a flexible outer penetrator having a longitudinal bore and a distal end operable to penetrate bone and associated bone marrow. The penetrator assembly may also include a rigid inner penetrator including a distal end operable to penetrate bone and associated bone marrow. A hub having a distal end is connected to a proximal end of the flexible outer penetrator. A connector having a distal end is connected to a proximal end of the rigid inner penetrator. A proximal end of the connector can releasably engage a driver. The longitudinal bore of the flexible outer penetrator can removably receive the rigid inner penetrator to prevent or minimize the flexible outer penetrator from bending during an insertion procedure. The flexible outer penetrator can bend after removal of the rigid inner penetrator from the longitudinal bore.

Abstract: A method of producing a ready-to-use medical device with a functional coating includes the steps of bringing the medical device, at least with its functional coating, in contact with a composition which prevents or retards degradation of the functional coating and sterilizing the medical device and the composition via radiation. A method leads to an improved product, namely an improved ready-to-use medical device which does not suffer a loss of quality during sterilization and storage. The composition comprises carboxymethyl cellulose or a derivative or salt thereof and/or an antioxidant selected from gallic acid or a derivative thereof.

Abstract: A ready to use catheter assembly comprises a catheter package with an opening, a catheter with a shaft arranged in the catheter package so a distal end of the catheter lies in the region of the opening, and a protective sleeve which partly covers the catheter shaft, a first end of the protective sleeve fixed to the distal end of the catheter. A method for producing a ready to use catheter assembly and a ready to use catheter assembly which further reduces the risk of an accidental contamination of a catheter when pulling it out of the catheter package prior to the insertion into the urethra of a user are provided. The opening has a defined maximum opening length, a second end of the protective sleeve is releasably connected which the catheter package near the maximum opening length of the opening and the protective sleeve is in a retracted state.

Abstract: A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes an antioxidant selected from gallic acid or a derivative thereof. A second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes carboxymethyl cellulose or a derivative or salt thereof. The use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions, are also provided. The wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf-life of the wetted coated product.

Abstract: A catheter may include a tubular member having a lumen and an outer surface, a sleeve configured to be positioned in the lumen in a retracted configuration and to evert over at least a portion of the outer surface in an everted configuration, and a filament configured to retract the sleeve into the retracted configuration. The catheter may include an aperture proximal of a distal end, where the filament extends through the aperture from the lumen. A pull member may be on a distal end of the filament. The filament may be looped, coiled, and/or bunched in the catheter when the sleeve is in the retracted configuration. A shuttle may be attached to a distal end of the sleeve, where the shuttle includes a tubular member configured to maintain patency of the sleeve, and the filament engages the shuttle to retract the sleeve into the lumen.