Granted Patent B2

US 12,654,030 · App. 18/179,246 · Granted Jun 16, 2026

Inventors: Peter Nakaji (Phoenix, AZ); David Brachman (Phoenix, AZ); Heyoung McBride (Phoenix, AZ); Emad Youssef (Peoria, AZ); Theresa Thomas (Gilbert, AZ)

Assignee: GT MEDICAL TECHNOLOGIES, INC.

A61N5/1014A61N5/1007A61N5/1027A61N5/103A61N2005/1009A61N2005/101A61N2005/1023A61N2005/1024

Abstract

Claims (39)

1 . A treatment method comprising:

determining one or more dimensions of a surgically created cavity;

determining a quantity of carriers based at least on the one or more dimensions and a radiation dose of the carriers, wherein each of the carriers comprises:

a biocompatible substrate comprising a unitary structure having a first surface, an opposing second surface, and a thickness greater than two millimeters and less than eight millimeters between the first surface and the second surface; and

one or more radionuclide seeds inserted within the biocompatible substrate between the first surface and the second surface via one or more preformed loading channels in a third surface of the biocompatible substrate; and

positioning the carriers on exposed surfaces of the surgically created cavity to apply radioactive energy from the one or more radionuclide seeds to at least some mammalian tissue forming the surgically created cavity.

2 . The treatment method of claim 1 , wherein at least some of the carriers include one or more indicator lines marking locations to cut the carriers to create a smaller sized radioactive seed carrier.

3 . The treatment method of claim 1 , wherein the one or more radionuclide seeds comprise Cesium-131.

4 . The treatment method of claim 1 , wherein the one or more radionuclide seeds comprise radioisotopes emitting gamma, beta or alpha particles.

5 . The treatment method of claim 1 , wherein the one or more radionuclide seeds are positioned within respective carriers in a manner that a longitudinal axis of the one or more radionuclide seeds is substantially parallel to the first surface of the respective carrier in which the one or more radionuclide seed is embedded.

6 . The treatment method of claim 1 , wherein the first and second surfaces are substantially circular.

7 . The treatment method of claim 1 , wherein the first and second surfaces are substantially rectangular.

8 . The treatment method of claim 1 , wherein at least some of the carriers comprise an indicator on the first surface to distinguish the first surface from the second surface, wherein the first surface is an antipodal surface, wherein the second surface is a treatment surface.

9 . The treatment method of claim 1 , wherein at least one of the carriers further comprises: a substrate including a therapeutic agent.

10 . The treatment method of claim 9 , wherein the therapeutic agent comprises one or more of gamma particles, beta particles, alpha particles, chemotherapy agent, tumoricidal agent, viral vector agent, or immunotherapeutic agent.

11 . The treatment method of claim 1 , wherein the carriers are positioned with reference to one another to form a preplanned dosimetrically customized implant.

12 . The treatment method of claim 1 , wherein at least one of the carriers further comprises a radiation shielding layer.

13 . The treatment method of claim 12 , wherein the radiation shielding layer comprises one or more of tantalum, tungsten, titanium, gold, or silver.

14 . The treatment method of claim 12 , wherein the radiation shielding layer comprises a high Z material.

15 . The treatment method of claim 12 , wherein the radiation shielding layer is positioned on the first surface of the biocompatible substrate.

16 . A method of producing a dosimetrically customizable implant, the method comprising:

(a) determining one or more dimensions of a surgically created cavity;

(b) providing a plurality of carriers each comprising:

a biocompatible substrate comprising a unitary structure having a first surface, an opposing second surface, and a thickness greater than two millimeters and less than eight millimeters between the first surface and the second surface; and

one or more radionuclide seeds inserted within the biocompatible substrate between the first surface and the second surface through one or more preformed loading channels in a third surface of the biocompatible substrate;

(c) positioning a first carrier on an exposed surface of the surgically created cavity;

(d) determining whether a dosimetric need is satisfied based on at least a targeted radionuclide dose of the first carrier delivering an effective dose of radiation to a tumor while minimizing radiation exposure to normal tissue;

(e) in response to determining that the dosimetric need is not satisfied, positioning one or more additional carriers on the exposed surface of the surgically created cavity adjacent an already placed carrier; and

(f) repeating (d) and (e) until the dosimetric need is satisfied.

17 . The method of claim 16 , wherein an orientation of the first carrier and an orientation of at least one of the one or more additional carriers are non-planar.

18 . The method of claim 16 , wherein the first carrier is positioned on a bottom of the surgically created cavity and at least one of the one or more additional carriers is positioned on a side of the surgically created cavity.

19 . A treatment method comprising:

determining one or more dimensions of a surgically created cavity;

providing a plurality of carriers each comprising:

a collagen-based substrate comprising a unitary structure having a first surface, and an opposing second surface; and

one or more radionuclide seeds inserted within the collagen-based substrate between the first surface and the second surface through one or more preformed loading channels extending through the collagen-based substrate from a third surface at a proximal end of the collagen-based substrate to a fourth surface at a distal end of the collagen-based substrate;

providing a radiation shielding layer comprising a high Z material; and

positioning the carriers and the radiation shielding layer on exposed surfaces of the surgically created cavity to apply radioactive energy from the one or more radionuclide seeds to at least some mammalian tissue forming the surgically created cavity.

20 . The treatment method of claim 19 , wherein the radiation shielding layer is positioned adjacent at least the first surface of the plurality of carriers.

Assignments (2)

Continuity (10)

References Cited (364)