Systems and methods for cleaning and disinfecting allograft material

Patent metadata

Field	Value
Publication number	US-9649395-B2
Application number	US-201514857271-A
Country	US
Kind code	B2
Filing date	Sep 17, 2015
Priority date	Apr 18, 2012
Publication date	May 16, 2017
Grant date	May 16, 2017

Abstract

There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

First claim

What is claimed is:

1. A system for cleaning and disinfecting allograft material, the system comprising:
a sterile bag having an outer wall configured to withstand compressive forces, a pair of paddle contact sections, and an allograft retaining section separate from the paddle contact sections;
a motorized paddle blender having at least two paddles, each having a compressive surface configured to apply compressive forces onto the sterile bag at the pair of paddle contact sections, a motorized portion to actuate the at least two paddles, and a door component configured to hold the sterile bag adjacent the at least two paddles, wherein the at least two paddles and the allograft retaining section are configured to prevent the at least two paddles from compressing the allograft material when the compressive forces are applied onto the sterile bag at the pair of paddle contact sections; and
a hollowed port system within each of the at least two paddles, the hollowed port system comprising inflow and outflow ports in fluid communication with a hollow interior of each of the at least two paddles, wherein throughout an actuation cycle of the at least two paddles, temperature-controlled solution constantly flows into each of the inflow ports, across the compressive surfaces of each of the at least two paddles, and out each of the outflow ports, providing a constant flow of the temperature-controlled solution across the compressive surfaces of each of the at least two paddles such that the compressive surfaces resist frictional heating and maintain a constant temperature throughout the actuation cycle; and
further comprising an internal screen defining the allograft retaining section at a central location between the pair of paddle contact sections, the central location defined by the internal screen configured to retain the allograft tissue between the pair of paddle contact sections to prevent tissue pummeling and to allow turbulent fluid flow therethrough, wherein the door component, the at least two paddles, the pair of paddle contact sections, and the central location of the allograft retaining section are configured with respect to one another to locate the compressive forces onto the sterile bag on the pair of paddle contact sections at positions away from the central location of the allograft retaining section so as to in turn provide a non-contact area at the central location to prevent application of the compression forces to the allograft material.

2. A system in accordance with claim 1 , wherein the sterile bag is a paddle blender bag having modifications to provide the allograft retaining section separate from the pair of paddle contact sections.

3. A system in accordance with claim 1 , wherein the at least two paddles are separated by a given distance to apply the compressive forces on the sterile bag at the pair of paddle contact sections, and wherein the allograft retaining section has a width less than the given distance separating the at least two paddles so as to allow the allograft retaining section to retain the allograft material between the pair of paddle contact sections corresponding to the at least two paddles.

4. A system for cleaning and disinfecting allograft material, the system comprising:
an ultrasonic water bath containing an amount of agitated fluid to receive and submerge a sterile bag mounted within a motorized paddle blender, wherein:
the sterile bag has an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section; and
the motorized paddle blender has at least one paddle configured to apply blending forces onto the sterile bag at the at least one paddle contact section, a motorized portion to actuate the at least one paddle, a door component configured to hold the sterile bag adjacent the at least one paddle, and an exterior inlet port and an exterior outlet port fluidly coupled with an exterior of the motorized paddle blender and located such that the agitated fluid flows through the exterior inlet port from the ultrasonic water bath into the motorized paddle blender, across the outer wall of the sterile bag, and through the exterior outlet port back into the ultrasonic water bath, wherein the at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied onto the sterile bag at the at least one paddle contact section.

5. A system in accordance with claim 4 , wherein the ultrasonic water bath is configured to control temperature of the allograft material.

6. A system in accordance with claim 5 , wherein the ultrasonic water bath is configured to transmit ultrasonic vibrations through the outer wall of the sterile bag to supplement mechanical washing of the allograft material with forces of fluid created by the at least one paddle.

7. A system in accordance with claim 4 , further comprising an internal screen defining the allograft retaining section at a location adjacent to the at least one paddle contact section, the location defined by the internal screen configured to retain the allograft tissue adjacent to the paddle contact section to prevent tissue pummeling and to allow turbulent fluid flow therethrough, wherein the door component, the at least one paddle, the paddle contact section, and the location of the allograft retaining section are configured with respect to one another to locate the blending forces onto the sterile bag on the paddle contact section at a position away from the allograft retaining section so as to in turn provide a non-contact area at the allograft retaining section to prevent application of the blending forces to the allograft material.

Assignees

• Allosource

Inventors

• Zajdowicz Jan

Classifications

• A61L2/04

  Heat (radiation A61L2/08) · CPC title

• A61L2/02

  using physical processes · CPC title

• A61L2/18 Primary

  Liquid substances · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L2/025 Primary

  Ultrasonic waves · CPC title