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Publication Number
US-10918835-B2
Publication Date
2021-02-16
Expiration Date
Abstract
Embodiments herein include delivery systems for active agent coated balloons and related methods. In an embodiment, a delivery system can include a tunneling sheath and a balloon catheter. The tunneling sheath can include a tubular shaft having an outer diameter and defining a lumen. The tunneling sheath can include a proximal collar defining a lumen. The balloon catheter can include a balloon catheter shaft disposed within the tubular shaft. The balloon catheter shaft can include a lumen for the passage of a fluid therein. The balloon catheter can include an expandable balloon disposed on the balloon catheter shaft. The balloon catheter shaft can include an active agent layer disposed on the expandable balloon. The position of the expandable balloon can be configured to be stationary relative to the tubular shaft as the delivery system is passed through a blood vessel of a patient. Other embodiments are also included herein.
Core Innovation
The disclosure provides a delivery system for introducing an active agent coated balloon into a subject. The delivery system includes a tunneling sheath with a tubular shaft defining a lumen and a proximal collar attached to the tubular shaft at the proximal end, where the proximal collar comprises an outer diameter greater than the outer diameter of the tubular shaft. A balloon catheter is disposed within the tubular shaft, including an expandable balloon in fluid communication with a lumen of a balloon catheter shaft and having an active agent layer disposed on the expandable balloon.
The proximal collar is configured to fasten onto the balloon catheter such that the position of the expandable balloon is stationary relative to the tubular shaft as the delivery system is passed through a blood vessel. After the balloon is transported adjacent the site to be treated, the proximal collar is unfastened from the balloon catheter so that the expandable balloon is passed at least part way out of the tubular shaft. A volume of the tubular shaft that is not taken up by the balloon catheter is filled with a liquid as the expandable balloon passes at least part way out of the tubular shaft.
The tunneling sheath is described as a balloon protector configured to reduce active-agent loss and prevent coating damage during handling, hemostatic valve passage, and transport. The disclosed device further includes an annular soft tip with a central aperture, apertures or ports, a radiopaque marker, and lubricious or hydrophilic coatings, and the document describes hydrophilic polymers, photoreactive or photocrosslinkable groups, photoactivatable groups, and active agents including paclitaxel, rapamycin, and derivatives thereof.
Claims Coverage
The document includes two independent claims, describing a delivery system and a method. Across these claims, the central inventive concepts are a tunneling sheath with a proximal collar that fastens to a balloon catheter to maintain a stationary balloon position during passage through a blood vessel, followed by releasing the collar, advancing the balloon catheter out of the tubular shaft, inflating the active-agent-coated expandable balloon, and filling unused shaft volume with liquid.
Tunneling sheath with proximal collar maintains stationary balloon position
A delivery system for introducing an active agent coated balloon into a subject comprising a tunneling sheath comprising a tubular shaft having an outer diameter and defining a lumen, a proximal collar defining a lumen attached to the tubular shaft at a proximal end with an outer diameter greater than the outer diameter of the tubular shaft; and a balloon catheter comprising a balloon catheter shaft disposed within the tubular shaft, an expandable balloon disposed on the balloon catheter shaft in fluid communication with the lumen of the balloon catheter shaft, and an active agent layer disposed on the expandable balloon, wherein the position of the expandable balloon is configured to be stationary relative to the tubular shaft with the proximal collar of the tunneling sheath fastened onto the balloon catheter as the delivery system is passed through a blood vessel.
Release of proximal collar and advancement of balloon catheter
Wherein the expandable balloon is configured be passed at least part way out of the tubular shaft after the proximal collar of the tunneling sheath is unfastened from the balloon catheter, and wherein a volume of the tubular shaft that is not taken up by the balloon catheter is filled with a liquid as the expandable balloon is passed at least part way out of the tubular shaft.
Method with stationary advancement, collar unfastening, and balloon inflation
A method of delivering an active agent coated balloon into a subject comprising fastening the proximal collar of the tunneling sheath onto the balloon catheter, advancing the delivery system through a blood vessel so that the position of the expandable balloon is stationary relative to the tubular shaft, unfastening the proximal collar of the tunneling sheath from the balloon catheter, advancing the balloon catheter shaft and the expandable balloon at least part way out of the tubular shaft, and inflating the expandable balloon so that it contacts the area to be treated.
Inserter through introducer sheath about the tunneling shaft
Wherein inserting a delivery system for introducing an active agent coated balloon into a subject further comprises inserting the delivery system through an introducer sheath configured to be disposed about the tubular shaft of the tunneling sheath.
Across the independent claims, the disclosed inventive coverage centers on maintaining relative stationarity of an active-agent-coated expandable balloon with respect to a tunneling tubular shaft during transit through a blood vessel by using a proximal collar fastened to the balloon catheter, then releasing the collar so the balloon can be advanced out of the tubular shaft, with unused shaft volume filled with liquid and, in the method claim, inflating the balloon to contact an area to be treated. The method further includes inserting the delivery system through an introducer sheath configured to be disposed about the tunneling shaft.
Stated Advantages
Reduces active-agent loss and prevents coating damage during handling, hemostatic valve passage, and transport.
Documented Applications
Delivering an active agent coated balloon into a subject so the expandable balloon contacts an area to be treated, including an area to be treated that is a lesion.
Delivering an active agent coated balloon into a subject via a delivery system advanced through a blood vessel.
Introducing a drug-eluting balloon catheter into a patient using a tunneling sheath to protect the balloon coating and maintain balloon position during blood-vessel passage.
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