An insertion system and a method for protecting an insertion device, for example, a needle, a catheter, a stent, etc., from infection and/or damage before, and/or during, and/or after insertion of the insertion device into an insertion site, are provided. The insertion system includes a hub or an introducer sheath with a hub, the insertion device, and an insertion device protection apparatus. The insertion device protection apparatus includes at least two elongate protective covers detachably engaged to each other and defining a channel extending through a length of the insertion device protection apparatus for enclosing the insertion device therewithin before, and/or during, and/or after inserting the insertion device into the insertion site. The elongate protective covers are progressively disengaged from each other from a proximal end and/or a distal end of the insertion device protection apparatus before, and/or during, and/or after insertion of the insertion device into the insertion site.

A wearable infusion pump assembly. The wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set. The fluid delivery system includes a controller, a pump assembly for extracting a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the external infusion set, the pump assembly comprising a pump plunger, the pump plunger having distance of travel, the distance of travel having a starting position and an ending position, at least one optical sensor assembly for sensing the starting position and ending position of the pump plunger distance of travel and sending sensor output to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, wherein the controller receives the sensor output and determines the total displacement of the pump plunger.

A wearable infusion pump assembly. The wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set. The fluid delivery system includes a controller, a pump assembly for extracting a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the external infusion set, the pump assembly comprising a pump plunger, the pump plunger having distance of travel, the distance of travel having a starting position and an ending position, at least one optical sensor assembly for sensing the starting position and ending position of the pump plunger distance of travel and sending sensor output to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, wherein the controller receives the sensor output and determines the total displacement of the pump plunger.

A device for injecting a product into a site, having: a body provided with a bearing wall for bearing on the site, a needle support mounted so as to be movable with respect to the bearing wall between: a pre-insertion position, at least one insertion position, and at least one retracted position, a catheter mounted so as to be movable with respect to the needle and intended to dispense product into the site, a drive unit intended to translate the needle support between the various positions of the needle support, a pump connected to a reservoir so as to transfer product from the reservoir to the catheter, a single electric motor intended to drive the drive unit and to supply the pump.

A device for injecting a product into a site, having: a body provided with a bearing wall for bearing on the site, a needle support mounted so as to be movable with respect to the bearing wall between: a pre-insertion position, at least one insertion position, and at least one retracted position, a catheter mounted so as to be movable with respect to the needle and intended to dispense product into the site, a drive unit intended to translate the needle support between the various positions of the needle support, a pump connected to a reservoir so as to transfer product from the reservoir to the catheter, a single electric motor intended to drive the drive unit and to supply the pump.

A device for delivering a medication to a patient in a drug infusion system is disclosed. The device is configured as a fully autonomous and integrated wearable apparatus for managing the medication delivery. The device comprises: a reservoir for storing the medication to be delivered to the patient; a continuous glucose monitoring device for monitoring glucose levels in the patient to set flow rates for medication delivery; a needle for delivering the medication from reservoir into the patient; and a pumping unit including one or more MEMS devices configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle at set flow rates and/or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle.

A device for delivering a medication to a patient in a drug infusion system is disclosed. The device is configured as a fully autonomous and integrated wearable apparatus for managing the medication delivery. The device comprises: a reservoir for storing the medication to be delivered to the patient; a continuous glucose monitoring device for monitoring glucose levels in the patient to set flow rates for medication delivery; a needle for delivering the medication from reservoir into the patient; and a pumping unit including one or more MEMS devices configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle at set flow rates and/or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle.

A medical puncture needle includes: a metal needle body formed in a tubular shape and including: a blade surface formed at a distal end portion of the needle body, a first transmission window configured to transmit light, and a second transmission window configured to transmit light transmitted through the first transmission window. The second transmission window is located on a proximal end side relative to the blade surface. The first transmission window and the second transmission window are shifted from each other in a circumferential direction of the needle body.

A drug delivery device includes a housing with at least one pressure communication channel or aperture, which distributes a negative fluid pressure across its base to draw tissue against the device. The device can also include a porous, adhesive layer over the channel(s) or aperture(s), for attaching to tissue. The device can also include a pressure sensor for determining whether there is proper attachment. Further, a bladder may be used instead of the adhesive layer for attaching the device. The bladder, in a partially inflated state, can apply constant pressure across a contact surface causing a flexible adhesive layer attached to the bladder to confirm and adhere to the tissue. Subsequent evacuation of the bladder causes it to deflate and collapse or retract, thereby causing the flexible adhesive layer to pull and stretch the tissue toward the base.

A drug delivery device includes a housing with at least one pressure communication channel or aperture, which distributes a negative fluid pressure across its base to draw tissue against the device. The device can also include a porous, adhesive layer over the channel(s) or aperture(s), for attaching to tissue. The device can also include a pressure sensor for determining whether there is proper attachment. Further, a bladder may be used instead of the adhesive layer for attaching the device. The bladder, in a partially inflated state, can apply constant pressure across a contact surface causing a flexible adhesive layer attached to the bladder to confirm and adhere to the tissue. Subsequent evacuation of the bladder causes it to deflate and collapse or retract, thereby causing the flexible adhesive layer to pull and stretch the tissue toward the base.