Systems, devices and methods for reconstituting therapeutic powders, mixing precursor solutions, and expressing sealants for controlling bleeding and sealing fluid and air leaks
Inventors
Guo, Jianxin • Dhanaraj, Sridevi N. • Ghodbane, Salim
Assignees
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Publication Number
US-12220118-B2
Publication Date
2025-02-11
Expiration Date
Abstract
A sealant delivery system includes a syringe assembly having side-by-side syringes and a vial assembly having side-by-side vials. A first vial is aligned with a distal end of a first syringe and has a vial opening at the proximal end thereof that is closed by a first sealing membrane. A second vial is aligned with a distal end of a second syringe and has a second vial opening at the proximal end thereof that is closed by a second sealing membrane. The vial assembly includes a first piercing element moveable between a retracted position and an extended position for piercing the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial, and a second piercing element moveable between a retracted position and an extended position for piercing the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial.
Core Innovation
The disclosure describes a sealant delivery system and methods for using a syringe assembly and a vial assembly to reconstitute therapeutic powders during surgery. The system includes side-by-side first and second syringes with first and second fluid chambers and a side-by-side first and second vial assembly coupled to the distal end of the syringe assembly.
Each vial is closed by a sealing membrane at a proximal vial opening aligned with the distal end of its corresponding syringe. Each sealing membrane is pierced by a moveable piercing element located between the distal end of a syringe and the proximal end of the corresponding vial, with a first piercing spike and a second piercing spike providing first fluid communication and second fluid communication, respectively.
The disclosure further characterizes reconstituting therapeutic powders by using first and second powdered reactive components in respective vials, with the first liquid and second fluid dispensed from corresponding syringes into the respective vials through the piercing-created fluid communication. The system is configured to provide separate therapeutic solutions in the first and second vials and support delivery of a cured tissue sealant/hemostat and sealing fluid/air leaks for controlling bleeding.
Claims Coverage
This partial set includes two independent claims, each focusing on a side-by-side syringe assembly coupled to a side-by-side vial assembly with piercing membranes to create fluid communication and reconstitute therapeutic components into separate therapeutic solutions. Across the independent claims, the inventive structure is a dual-channel piercing arrangement that enables reconstitution while maintaining separate fluid pathways for a corresponding first and second syringe and vial pair.
Side-by-side syringe assembly with paired fluid chambers
A syringe assembly including side-by-side first and second syringes, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber.
Side-by-side vial assembly with sealing membranes aligned to syringes
A vial assembly coupled to a distal end of the syringe assembly, the vial assembly including side-by-side first and second vials, where the first vial has a proximal end aligned with a distal end of the first syringe and a first vial opening at the proximal end closed by a first sealing membrane, and the second vial has a proximal end aligned with a distal end of the second syringe and a second vial opening at the proximal end closed by a second sealing membrane.
First piercing element forming fluid communication to first vial
A first piercing element located between the distal end of the first syringe and the proximal end of the first vial, the first piercing element having a first piercing spike projecting from a distal end thereof, the first piercing element being moveable between a retracted position with the first piercing spike on a proximal side of the first sealing membrane and an extended position with the first piercing spike passing through the first sealing membrane to provide first fluid communication between the first fluid chamber of the first syringe and the first vial.
Second piercing element forming fluid communication to second vial
A second piercing element located between the distal end of the second syringe and the proximal end of the second vial, the second piercing element having a second piercing spike projecting from a distal end thereof, the second piercing element being moveable between a retracted position with the second piercing spike on a proximal side of the second sealing membrane and an extended position with the second piercing spike passing through the second sealing membrane to provide second fluid communication between the second fluid chamber of the second syringe and the second vial.
First and second liquid and powdered reactive components for separate reconstitution
A sealant delivery system where the first fluid chamber contains a first liquid, the second fluid chamber contains a second fluid, the first vial contains a first powdered reactive component, and the second vial contains a second powdered component.
The independent claims define a two-channel sealant delivery system using side-by-side syringe chambers and side-by-side vials with respective sealing membranes. Each independent claim centers on moveable piercing elements that create fluid communication from each corresponding syringe to its matched vial, enabling reconstitution involving liquid and powdered reactive components into first and second vials for therapeutic delivery.
Stated Advantages
Controlling bleeding and sealing fluid/air leaks during surgery by delivering a cured tissue sealant/hemostat.
Documented Applications
Use for curing tissue sealant/hemostat delivery during lung surgery for sealing fluid/air leaks and controlling bleeding.
Bleeding control and sealing fluid/air leaks in lung, liver, and GI resections.
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