# US 8,784,800 B2 · Method of delivering cell therapy to a target site > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,800 B2 - Document ID: US8784800B2 - Status: Granted - Kind: B2 - Application number: 12/400,059 - Filed: 2009-03-09 - Published: 2010-09-09 - Granted: 2014-07-22 - Earliest claimed: 2009-03-09 - Assignees: Medtronic, Inc. - Applicants: Mary M. Morris; Kenneth Gardeski; Laurent Verard; Kevin Thomas Wu; Michael R. Neidert - Inventors: Mary M. Morris; Kenneth Gardeski; Laurent Verard; Kevin Thomas Wu; Michael R. Neidert - Web page: https://patentgrep.com/patent/US8784800B2 ## CPC - A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells - A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient} - A61B 6/12: Arrangements for detecting or locating foreign bodies - A61B 6/481: {involving the use of contrast agents} - A61B 6/487: {involving fluoroscopy} - A61B 6/541: {involving acquisition triggered by a physiological signal} - A61K 35/39: Pancreas; Islets of Langerhans (Langerhans cells of epidermis A61K35/36) - A61K 49/0017: {Fluorescence in vivo} - A61K 49/06: Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations - A61B 5/7285: {for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method of delivering therapy to a target site. The method includes (a) obtaining a base image of the target site, (b) injecting a dose of a mix of a therapeutic agent and a contrast agent into a first injection location at the target site via a needle passing through a catheter, (c) collecting sequential fluoroscopic images of a contrast agent dispersion cloud at the first injection location, (d) determining a contrast agent dispersion area from the sequential fluoroscopic images, (e) determining a therapeutic agent dispersion area from the contrast agent dispersion area, (f) marking the therapeutic agent dispersion area on the base image of the target site, and (g) repeating (b) through (f) until the target site is substantially covered with overlapping therapeutic agent dispersion areas corresponding to a plurality of injections at a plurality of injection locations at the target site. ## Claims ### Claim 1 A method of delivering therapy to a target site, the method comprising: (a) obtaining a base image of the target site; (b) navigating a catheter to the target site; (c) injecting a dose of a mix of a therapeutic agent and a contrast agent into a first injection location at the target site; (d) collecting sequential fluoroscopic images of a contrast agent dispersion cloud at the first injection location; (e) determining a contrast agent dispersion region from the sequential fluoroscopic images; (f) identifying a tissue type of the first injection location; (g) determining a therapeutic agent dispersion region from the contrast agent dispersion region; (h) marking the therapeutic agent dispersion region on the base image of the target site; and (i) repeating (b) through (h) until the target site is substantially covered with overlapping therapeutic agent dispersion regions corresponding to a plurality of injections at a plurality of injection locations at the target site, wherein a plurality of the therapeutic agent dispersion regions are presented on the base image at the same time. ### Claim 2 (depends on 1) The method of claim 1, wherein determining a contrast agent dispersion region includes determining a size of the contrast agent dispersion cloud as a function of time. ### Claim 3 (depends on 2) The method of claim 2, wherein determining a contrast agent dispersion region includes determining a duration of the contrast agent dispersion cloud as a function of time. ### Claim 4 (depends on 3) The method of claim 3, wherein determining a contrast agent dispersion region includes determining an intensity of the contrast agent dispersion cloud as a function of time. ### Claim 5 (depends on 4) The method of claim 4, wherein determining a contrast agent dispersion region includes determining a time derivative of intensity of the contrast agent dispersion cloud as a function of time. ### Claim 6 (depends on 1) The method of claim 1, wherein determining a therapeutic agent dispersion region from the contrast agent dispersion region comprises determining a therapeutic agent dispersion area from the contrast agent dispersion area using two-dimensional fluoroscopic images. ### Claim 7 (depends on 6) The method of claim 6, wherein determining a therapeutic agent dispersion area from the contrast agent dispersion area comprises correlating the therapeutic agent dispersion area and the contrast agent dispersion with a parameter that depends on a tissue type of the injection location. ### Claim 8 (depends on 1) The method of claim 1, wherein injecting a dose of a mix of a therapeutic agent and a contrast agent into a first injection location at the target site comprises injecting a dose through an injection needle, the injection needle passing through a deflectable catheter, the deflectable catheter including a removable navigation insert. ### Claim 9 (depends on 1) The method of claim 1, wherein injecting a dose of a mix of a therapeutic agent and a contrast agent into a first injection location at the target site comprises injecting a dose through an injection needle, the injection needle passing through an integrated deflectable multi-lumen navigation/therapy delivery catheter. ### Claim 10 (depends on 1) The method of claim 1, wherein the therapeutic agent comprises at least one of the following types of cells: islet cells, pluripotent stern cells, mesenchymal stem cells, endodermal stem cells, ectodermal stem cells, hepatocytes, chondrocytes, osteoblasts, neuronal cells, glial cells, smooth muscle cells, endothelial cells, skeletal myoblasts, myoblasts, macrophages, erythrocytes, platelets, and fibroblasts. ### Claim 11 (depends on 1) The method of claim 1, wherein determining the therapeutic agent dispersion region comprises determining the therapeutic dispersion region based on the tissue type identified at the first injection location in combination with the contrast agent dispersion region. ### Claim 12 (depends on 1) The method of claim 1, wherein identifying a tissue type of the first injection location comprises analysis of the sequential fluoroscopic images of the contrast agent dispersion cloud at the first injection location. ### Claim 13 A method of delivering therapy to a target site, the method comprising: obtaining a base image of the target site; navigating a catheter including a delivery needle to the target site; injecting through the needle a first dose of a mix of a therapeutic agent and a contrast agent into a first injection location at the target site; collecting sequential fluoroscopic images of a contrast agent dispersion cloud at the first injection location; determining a contrast agent dispersion region from the sequential fluoroscopic images of the first injection location; identifying a tissue type of the first injection location; determining a therapeutic agent dispersion region from the contrast agent dispersion region of the first injection location; marking the therapeutic agent dispersion region of the first injection location on the base image of the target site; injecting through the needle a second dose of a mix of a therapeutic agent and a contrast agent into a second injection location different from the first injection location at the target site; and determining a therapeutic agent dispersion region for the second injection location and marking the therapeutic agent dispersion region for the second injection location on the base image of the target site, wherein a plurality of the therapeutic agent dispersion regions are presented on the base image at the same time. ### Claim 14 (depends on 13) The method of claim 13, further comprising collecting sequential fluoroscopic images of a contrast agent dispersion cloud at the second injection location. ### Claim 15 (depends on 14) The method of claim 14, further comprising determining a contrast agent dispersion region from the sequential fluoroscopic images at the second injection location. ### Claim 16 (depends on 15) The method of claim 15, further comprising determining a therapeutic agent dispersion region from the contrast agent dispersion region at the second injection location. ### Claim 17 (depends on 16) The method of claim 16, further comprising marking the therapeutic agent dispersion region of the second injection location on the base image of the target site. ### Claim 18 (depends on 13) The method of claim 13, wherein determining the therapeutic agent dispersion region comprises determining the therapeutic dispersion region based on the tissue type identified at the first injection location in combination with the contrast agent dispersion region of the first injection location. ### Claim 19 (depends on 13) The method of claim 13, wherein identifying a tissue type of the first injection location comprises analysis of the sequential fluoroscopic images of the contrast agent dispersion cloud at the first injection location.