Abstract: Packaging systems and methods for wet storage and/or shipping of prosthetic heart valve or other medical devices are disclosed.

Abstract: A package includes a tray and a cover configured to seal an open end of the tray when the cover is assembled onto the tray. The tray has a flange extending about a periphery at the open end of the tray. A continuous barrier seal is formed between the flange and the cover when the cover is assembled onto the tray, and a discontinuous sacrificial seal is also formed between the flange and the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. The continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal. Holes are formed on the corners of the flange, and the holes are spaced apart from the discontinuous sacrificial seal.

Abstract: In some examples, a package includes a package body enclosing a medical supply. The package body defines a window. The package includes a breathable membrane adjacent the package body and extending across the window. The package includes a moisture oxygen scavenger adjacent the package body and extending across the breathable membrane. The package includes an adhesive layer configured to hold the moisture oxygen scavenger adjacent the breathable membrane. In some examples, a technique includes sterilizing a package precursor including the package body and the breathable membrane, and after the sterilizing, adhering the moisture oxygen scavenger to the package body to form the package.

Abstract: A catheter includes a proximal shaft, a distal shaft, a pressure sensor, and at least one pressure sensor wire. The proximal shaft is substantially C-shaped such that in cross-section, the proximal shaft includes a first circumferential end, a second circumferential end, and a gap between the first circumferential and circumferential end. The proximal shaft defines a groove configured to receive a guidewire therein. The distal shaft is coupled to the proximal shaft and defines a guidewire lumen therein. The pressure sensor is coupled to the distal shaft. The pressure sensor wire is operably connected to the pressure sensor. A proximal portion of the pressure sensor wire is disposed within a proximal shaft wall of the proximal shaft and a distal portion of the pressure sensor wire is disposed within a distal shaft wall of the distal shaft.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to a distal portion of the proximal shaft, and a pressure sensor coupled to the distal shaft. The proximal shaft includes a distal portion configured to extend through a stenosis in a vessel. The distal portion of the proximal shaft includes a radially expanded configuration having a first diameter and a radially collapsed configuration having a second diameter, wherein the first diameter is larger than the second diameter. The distal shaft includes a guidewire lumen configured to receive therein.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to the proximal shaft, a pressure sensor coupled to the distal shaft, and at least one pressure sensor wire operably connected to the pressure sensor. The proximal shaft includes a radially expanded configuration and a radially collapsed configuration, wherein the proximal shaft has a first outer diameter in the radially expanded configuration and a second outer diameter smaller than the first outer diameter in the radially collapsed configuration. The distal shaft defines a guidewire lumen configured to receive a guidewire therein.

Abstract: A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

Abstract: A package includes a tray and a cover configured to seal an open end of the tray when the cover is assembled onto the tray. The tray has a flange extending about a periphery at the open end of the tray. A continuous barrier seal is formed between the flange and the cover when the cover is assembled onto the tray, and a discontinuous sacrificial seal is also formed between the flange and the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. The continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal. Holes are formed on the corners of the flange, and the holes are spaced apart from the discontinuous sacrificial seal.

Abstract: In some examples, a package includes a package body enclosing a medical supply. The package body defines a window. The package includes a breathable membrane adjacent the package body and extending across the window. The package includes a moisture oxygen scavenger adjacent the package body and extending across the breathable membrane. The package includes an adhesive layer configured to hold the moisture oxygen scavenger adjacent the breathable membrane. In some examples, a technique includes sterilizing a package precursor including the package body and the breathable membrane, and after the sterilizing, adhering the moisture oxygen scavenger to the package body to form the package.

Abstract: A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

Abstract: A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to the proximal shaft, a pressure sensor coupled to the distal shaft, and at least one pressure sensor wire operably connected to the pressure sensor. The proximal shaft includes a radially expanded configuration and a radially collapsed configuration, wherein the proximal shaft has a first outer diameter in the radially expanded configuration and a second outer diameter smaller than the first outer diameter in the radially collapsed configuration. The distal shaft defines a guidewire lumen configured to receive a guidewire therein.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to a distal portion of the proximal shaft, and a pressure sensor coupled to the distal shaft. The proximal shaft includes a distal portion configured to extend through a stenosis in a vessel. The distal portion of the proximal shaft includes a radially expanded configuration having a first diameter and a radially collapsed configuration having a second diameter, wherein the first diameter is larger than the second diameter. The distal shaft includes a guidewire lumen configured to receive therein.

Abstract: A catheter includes a proximal shaft, a distal shaft, a pressure sensor, and at least one pressure sensor wire. The proximal shaft is substantially C-shaped such that in cross-section, the proximal shaft includes a first circumferential end, a second circumferential end, and a gap between the first circumferential and circumferential end. The proximal shaft defines a groove configured to receive a guidewire therein. The distal shaft is coupled to the proximal shaft and defines a guidewire lumen therein. The pressure sensor is coupled to the distal shaft. The pressure sensor wire is operably connected to the pressure sensor. A proximal portion of the pressure sensor wire is disposed within a proximal shaft wall of the proximal shaft and a distal portion of the pressure sensor wire is disposed within a distal shaft wall of the distal shaft.

Abstract: A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.