Patient specific medical balloon forming machine and system
Inventors
Bean, Maxwell • Jensen, Morten • Uretsky, Barry • Elmer, Kaitlyn
Assignees
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Publication Number
US-12186508-B2
Publication Date
2025-01-07
Expiration Date
Abstract
Patient specific medical balloons, assemblies, and systems for forming the same, and devices and methods for treating patients in need of a percutaneous coronary intervention (PCI) are disclosed. The assembly for forming the medical balloon comprises a form for receiving a parison where the form is configured to prepare a patient specific medical balloon matched in geometry to a blood vessel or a lesion for a patient in need of a PCI.
Core Innovation
The invention relates to a method for forming a tapered parison by providing an assembly for forming a medical balloon. The assembly includes a form for receiving a parison, a heated jaw configured to surround the form and heat the parison to a balloon forming temperature, and a conduit fluidly connected to a pressurizing system to provide a balloon forming medium for expanding the parison within the form. A tensioning device is configured to apply tension to the parison within the form, and the assembly optionally includes one or more controllers for controlling the heating element, the pressurizing system, or the tensioning device.
The form is configured to prepare a patient specific medical balloon matched in geometry to a blood vessel or a lesion therein of a patient in need of a percutaneous coronary intervention (PCI). The assembly further includes a proximal stopper and a distal stopper configured to provide a desired cone geometry to a proximal end and a distal end of the patient specific medical balloon.
The method includes heating a first portion of the parison with the heated jaw surrounding the form, tensioning the heated parison, and cooling the parison under tension. A second portion of the cooled parison is then positioned within the form with coupling of the first end and the second end reversed from the coupling prior to tensioning and heating. The second portion is heated with the heated jaw, tensioned with the tensioning device, and cooled under tension, to form the tapered parison.
Claims Coverage
The independent claim defines six inventive features centered on forming a tapered parison into a patient specific medical balloon for PCI using a geometry-matched form, heated jaw heating, a pressurizing conduit, a tensioning device, proximal and distal stoppers, and a two-stage reversed coupling sequence.
Geometry-matched patient specific form for PCI balloon geometry
A form for receiving a parison, configured to prepare a patient specific medical balloon matched in geometry to a blood vessel or a lesion therein of a patient in need of a percutaneous coronary intervention (PCI).
Heated jaw thermally coupled to a heating element
A heated jaw configured to surround the form and heat the parison within the form to a balloon forming temperature, wherein the heated jaw is thermally coupled to a heating element.
Pressurizing conduit providing balloon forming medium
A conduit configured to provide a balloon forming medium for expanding the parison within the form, wherein the conduit is fluidly connected to a pressurizing system for pressurizing the balloon forming medium.
Tensioning device with cooling under tension
A tensioning device configured to apply tension to the parison within the form, including cooling the parison under tension during the method.
Proximal and distal stoppers providing desired cone geometry
A proximal stopper and a distal stopper configured to provide a desired cone geometry to a proximal end and a distal end of the patient specific medical balloon.
Two-stage heating/tensioning/cooling with reversed end coupling
Positioning a first portion and coupling parison ends to the tensioning device, then heating, tensioning, and cooling under tension; positioning a second portion after cooling and reversing the coupling of the first end and the second end from the coupling prior to tensioning and heating; then heating, tensioning, and cooling under tension again.
The coverage centers on producing a tapered parison for a patient specific medical balloon for PCI by combining a geometry-matched form, heated jaw heating, pressurizing balloon forming medium delivery, tensioning during cooling, proximal and distal cone control, and a two-part process with reversed parison end coupling.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Forming a patient specific medical balloon for a percutaneous coronary intervention (PCI) in a blood vessel.
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