Method of dose controlled application of bone graft materials by weight

Inventors

Bagga, Charanpreet S. • Bae, Hyun W.

Assignees

Prosidyan Inc

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Publication Number

US-9814804-B2

Patent

Publication Date

2017-11-14

Expiration Date


Abstract

Methods of providing dose controlled application of bone graft materials are disclosed. In particular, methods for determining a target quantity of bone graft material for clinical application in order to ensure maximum clinical results are provided. These methods comprise determining the target weight of the material to be applied.

Core Innovation

The invention provides a consistent, dose controlled application of a graft material to a defect by using density-based and porosity-related dosing. For a compressible or expandable, porous graft material, a density value of the graft material is determined, and a target weight of a quantity of graft material to be applied is calculated based on the determined density value. The quantity representing the target weight is then applied to the defect.

In another aspect, the invention uses a dosage reference chart to link defect physical parameters to a recommended graft material attribute. A dosage reference chart includes a physical parameter of the defect and a corresponding recommended attribute of the graft material, where the attribute is either a recommended dosage by weight or a target porosity value. A clinical evaluation is performed to determine the physical parameter of the defect, the chart is referenced to determine the required attribute, and a quantity of graft material having the required attribute is applied to the defect.

In yet another aspect, the invention uses a series of pre-sized containers that correlate defect volume with recommended dosages by weight. The containers have a range of volumes corresponding to a range of defect volumes, and the respective container volumes provide recommended dosages by weight of the graft material. A clinical evaluation is performed to determine a volume of the defect, a pre-sized container is selected based on the determined volume, and the graft material of the selected container is applied to the defect.

Claims Coverage

The document includes three independent claims. Across them, the inventive features cover density-based target-weight calculation, chart-based determination of a required graft attribute from clinically evaluated defect parameters, and pre-sized container selection mapped to defect volume with recommended dosage by weight.

Density value based target weight for compressible or expandable porous graft material

providing a compressible or expandable, porous graft material; determining a density value of the graft material; calculating a target weight of a quantity of the graft material to be applied based on the determined density value; and applying the quantity of graft material representing the target weight calculated to the defect.

Dosage reference chart mapping defect physical parameter to recommended graft attribute

providing a dosage reference chart comprising a physical parameter of the defect and a corresponding recommended attribute of the graft material, the attribute being either of a recommended dosage by weight or a target porosity value; performing a clinical evaluation to determine the physical parameter of the defect; referencing the chart to determine the required attribute of the graft material for the determined physical parameter of the defect; and applying a quantity of graft material having the required attribute to the defect.

Pre-sized containers selected by defect volume with recommended dosage by weight

providing a series of pre-sized containers of graft material, the containers having a range of volumes corresponding to a range of defect volumes, wherein recommended dosages by weight of the graft material corresponding to the range of defect volumes are provided in the respective container volumes; performing a clinical evaluation to determine a volume of the defect; selecting a pre-sized container of graft material based on the determined volume of the defect; and applying the graft material of the selected container to the defect.

Overall, the claims provide consistent, dose controlled application by (i) converting graft material density and porosity-related parameters into a target weight, (ii) determining a required graft attribute through a dosage reference chart based on clinically evaluated defect physical parameters, and (iii) using pre-sized containers where defect volume selects the container with a recommended dosage by weight.

Stated Advantages

Consistent, dose controlled application of a graft material to a defect.

Reduction of inconsistent dosing associated with porous compressible/expandable, porous fibrous/granular bone graft handling and variable final porosity.

Documented Applications

Spinal interbody fusion.

Metaphyseal bone void fill.

Posterolateral fusion.

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