Abstract: Pen injection devices (10) and methods of using a pen injection device are disclosed. Pen injection devices include a sterile dual transfer spike assembly (150) including a dual transfer spike defining a fluidic pathway; a first cartridge assembly (12) including a first cartridge (20) containing a first substance; a second cartridge assembly (14) including a second cartridge (30) containing a second substance; a plunger rod (50) translatable in a first direction; and a biasing mechanism (60) configured to bias the plunger rod in a second direction opposite the first direction. Methods of using a pen injection device having a first container, a second container, a plunger rod, and a biasing mechanism include activating the pen injection device, thereby creating a fluidic pathway between the first container and the second container; and translating the plunger rod at least once, thereby transferring a first substance from one container to the other container to mix with a second substance.

Abstract: A hypodermic needle assembly and a method of delivering a microsphere drug. A hypodermic needle assembly includes an injection needle; an injection device; and a hub defining a cavity including a transition portion having a first end and a second end between the first end and an inlet of the injection needle and having a gradually decreasing diameter from the first end to the second end, wherein the hub is coupled between the injection needle and the injection device such that the first end is in fluidic communication with an outlet of the injection device and the second end is in fluidic communication with the inlet of the injection needle, wherein the diameter of the cavity at the first end is larger than an outlet diameter of the injection device, and wherein the diameter at the second end is substantially the same as an inlet diameter of the injection needle.

Abstract: Pen injection devices (10) and methods of using a pen injection device are disclosed. Pen injection devices include a sterile dual transfer spike assembly (150) including a dual transfer spike defining a fluidic pathway; a first cartridge assembly (12) including a first cartridge (20) containing a first substance; a second cartridge assembly (14) including a second cartridge (30) containing a second substance; a plunger rod (50) translatable in a first direction; and a biasing mechanism (60) configured to bias the plunger rod in a second direction opposite the first direction. Methods of using a pen injection device having a first container, a second container, a plunger rod, and a biasing mechanism include activating the pen injection device, thereby creating a fluidic pathway between the first container and the second container; and translating the plunger rod at least once, thereby transferring a first substance from one container to the other container to mix with a second substance.

Abstract: The present invention provides improved devices and methods for making a small incision with a surgical scalpel through skin overlying an intercostal space to establish an access tract for the subsequent placement of minimally invasive direct cardiac massagers, chest tubes, defibrillation electrodes, and the like. A sheathed scalpel according to the present invention comprises a handle having a proximal end and a distal end, a cutting blade attached to the distal end of the handle and having a cutting edge and a tip, and a sheath attached to the handle and having a central passage configured to receive the blade. The sheath covers the blade when the blade is retracted within the central passage and exposes the cutting edge of the blade but not the tip when the blade is advanced within the central passage.

Abstract: A cardiac electrode deployment device comprises a support and an electrode structure deployable from the support. The electrode structure includes a planar region and a conformable, raised center region, wherein the electrode surfaces on the planar region and on the center region are electrically isolated from each other. The electrode structure is configured to engage against an outer surface of the heart, such as the pericardium, in order to provide electrical contact with the heart for EKG monitoring of the heart, delivery of pacing energy, and/or other low power applications. Usually, the electrode structure will also be suitable for performing direct cardiac massage.

Abstract: The present invention provides templates, methods, and kits for locating a site on a patient's chest suitable for establishing percutaneous intercostal access to the patient's heart. In particular, the present invention provides templates, methods, and kits which effectively and rapidly locate an incision site for intercostal access by sharp and/or blunt dissection for subsequent placement of minimally invasive direct cardiac massagers, chest tubes, defibrillation electrodes, and the like. An incision template according to the present invention comprises a structure placeable on a patient's chest. The structure has at least one marker which can be aligned with at least one anatomical feature of the patient and a target zone which lies over a preselected location for intercostal access when the marker is aligned with the anatomical feature.

Abstract: The present invention provides devices and methods for monitoring performance of minimally invasive direct cardiac massage. In particular, the present invention provides devices and methods which greatly facilitate proper performance of minimally invasive direct cardiac compression. Devices according to the present invention may comprise a handle, having a proximal end and a distal end, a structure attached to a distal end of the handle adapted to contact the pericardium or other heart surface to compress the heart, and a force transducer coupled to the handle and/or the structure to produce a signal which corresponds to an amount of force applied through the handle to the heart. A signal processor receives the force transducer signal and produces an output corresponding to the applied force. A display receives the output of the signal processor and produces a human decipherable indication based on the applied force.