Fluid flowing device and method for tissue diagnosis or therapy

{
  "publication_number": "US2010274178A1",
  "country": "US",
  "kind": "A1",
  "title": "Fluid flowing device and method for tissue diagnosis or therapy",
  "abstract": "A device and method for safely securing a multilumen device to a tissue, organ or solid tumor within the body of a human during a diagnostic or therapeutic procedure is described. The device is capable of securing the tumor by touching or piercing its surface and providing a coolant to the distal tip. Cooling the tip forms a cryogenically induced region that tightly binds the tip to the tumor, temporarily sealing the entry-track of the instrument. The device further provides at least one injecting/aspirating lumen that can dispense or aspirate a fluid within the tumor, and an outer sheath or guide. Such construction allows injecting part or whole volume of the tumor while the cryogenically induced bond prevents back-flow of the injected substances through the entry-track.",
  "claims": [
    "1. A backflow limiting device for delivery of at least one treating composition to a treatment region of a tissue structure comprising: a multilumen catheter including at least one lumen for supply of a cryogenic material, said lumen in fluid connection with at least one cryogenic element effective for lowering at least a portion of said tissue structure to a temperature at or about the tissue freezing point, and at least one lumen having a delivery end for providing said at least one treating composition to an interstitial space within said tissue structure of said treating composition positioned distally from said at least one lumen for supply of a cryogenic material; said multilumen catheter being constructed and arranged for injecting said at least one composition to a treatment region within said tissue structure in conjunction with supply of said cryogenic material; and an outer sheath member coaxially aligned with said multilumen catheter; whereby at least one cryogenically induced region is formed proximal to a point of delivery of said treating composition and which is effective to minimize or prevent backflow of said treating composition. 2. The backflow limiting device according to claim 1 wherein said outer sheath member contains at least one lumen. 3. The backflow limiting device according to claim 2 wherein said at least one lumen is a cryogenic fluid lumen. 4. The backflow limiting device according to claim 1 wherein said outer sheath member slideably engages said multilumen catheter whereby the relative position of said outer sheath member with respect to said multilumen catherter can be adjusted. 5. The backflow limiting device according to claim 1 wherein said outer sheath member is made of thermal conducting materials, plastics, porous materials, non-porous materials, flexible materials, rigid materials, or combinations thereof. 6. The backflow limiting device according to claim 1 wherein said multilumen catheter is further constructed and arranged for forming at least one cryogenically induced region proximal to said point of delivery of said treating composition and at least one cryogenically induced region distal to said point of delivery of said treating composition. 7. The backflow limiting device according to claim 6 wherein said multilumen catheter contains a side port positioned between said at least one cryogenically induced region formed proximal to said point of delivery of said treating composition and at least one cryogenically induced region formed distal to said point of delivery of said treating composition. 8. The backflow limiting device according to claim 1 wherein outer sheath member contains a closed end. 9. The backflow limiting device according to claim 1 wherein said treating composition is selected from the group consisting of saline solution, heating or cooling fluids, a photosensitizer, a radiosensitizer, a radioisotope, a sclerosing agent, radioseeds, thermoseeds, glue, a vaccine, a gene, a gene vector, biologically active peptides, proteins, an immunologic factor, a hormone, a cytotoxic agent, free or encapsulated drugs, and combinations thereof. 10. The backflow limiting device according to claim 1 further including sensors for sensing tissue parameters selected from the group consisting of electrical impedance, temperature, pressure, optical characteristics and combinations thereof. 11. The backflow limiting device according to claim 1 wherein said multilumen catheter further includes at least one lumen for aspiration of tissue fluids, cells or other compositions. 12. The backflow limiting device according to claim 1 wherein at least one lumen slidably engages the outer surface of said multilumen catheter and is in parallel arrangement with said lumen for supplying of cryogenic material. 13. The backflow limiting device according to claim 1 wherein at least one lumen is constructed to house at least one variable length applicator and/or needle. 14. The backflow limiting device according to claim 13 wherein said at least one variable length applicator and/or needle is deployable in situ. 15. The backflow limiting device according to claim 13 wherein said variable length applicator and/or needle further includes at least one sensor for sensing tissue parameters selected from the group consisting of electrical impedance, temperature, pressure, optical characteristics and combinations thereof. 16. The backflow limiting device according to claim 1 wherein said device further includes means for providing a source of interstitial energy to said treatment region selected from the group consisting of thermal, sonic, light, electroporation and combinations thereof. 17. A process for controllably delivering a treating composition to a tissue structure along an entry track comprising: providing a backflow limiting device, said device having a multilumen catheter including at least one lumen for supply of a cryogenic material, said lumen in fluid connection with at least one cryogenic element effective for lowering at least a portion of said tissue structure to a temperature within the range of at or about the tissue freezing point, and at least one lumen for providing said at least one treating composition to an interstitial space within said tissue structure positioned distally from said at least one lumen for supply of a cryogenic material, and an outer sheath member coaxially aligned with said multilumen catheter; said multilumen catheter being constructed and arranged for injecting said at least one treating composition to a treatment region within said tissue structure in conjunction with supply of said cryogenic material; positioning said backflow limiting device within or proximate to said tissue treatment region; securing said backflow limiting device to said tissue structure by delivering cryogenic agent to a portion of said multilumen catheter lumen, whereby at least one cryogenically induced region is formed proximal to a point of delivery of said treating composition and which is effective to minimize or prevent backflow of said treating composition; maintaining said cryogenically induced region; and delivering said treating composition to said treatment region within said tissue structure by injection; whereby backflow of said treating composition through the entry track is prevented. 18. The process according to claim 17 wherein said treatment site is a benign or malignant tumor, or a dysfunctional zone of an organ or target tissue. 19. The process according to claim 18 further includes identifying said treatment site by using sensors for sensing tissue parameters selected from the group consisting of electrical impedance, temperature, pressure, optical characteristics, and combinations thereof. 20. The process of claim 19 whereby tissue fluids, cells or other compositions are aspirated from said tissue structure. 21. The process according to claim 17 further including a step of providing cooling and deposition of a composition to said treatment region effective for ablating. 22. The step of ablating according to claim 21 further comprising two or more repeated cooling and freezing cycles alternating with warming periods. 23. The process according to claim 17 wherein said step of securing said backflow limiting device to said tissue structure by delivering said cryogenic agent to a portion of said multilumen catheter further includes the formation of at least one cryogenically induced region distal to said point of delivery of said treating composition."
  ],
  "description_excerpt": "The present invention relates to fluid delivery devices and methods for delivering direct tissue injection/aspiration to tissue structures within the body. More specifically, the invention relates to a self-anchoring, anti-flow back device capable of securing to a targeted tissue region during diagnostic and/or therapeutic procedures while further providing for optimal injection of compositions to the target tissue structure and the methods of use thereof.\n\nDirect deposition of agents interstitially can be of significant beneficial value and is effected by needle or catheter use. Tissue injection has long been a popular, relatively non-invasive means for the direct introduction of various medicaments and other fluids. It is becoming more popular as a means for non-invasive delivery of pharmaceutical preparations of cytotoxic drugs and drug delivery systems into solid tumor because it minimizes tissue trauma, increases local efficacy, and decreases side effects and systemic toxicity. Direct injection, using needles, catheters, or a combined deposition system, is a practical delivery strategy for antiangiogenesis, tumor embolization, hemostasis, and direct cell kill. Direct interstitial chemotherapy is slowly gaining ground among the medical community. A growing number of research papers and clinical reports published during the years 1990-2000 have shown improved efficacy and reduced toxicity in animal as well as in human tumors (E. P. Goldberg et al., J. Pharm Pharmacol 54(2):159-180 (2002)).",
  "cpc": [
    "A61F 7/12",
    "A61B 18/02",
    "A61B 2018/00041",
    "A61B 2018/0022",
    "A61B 2018/0212",
    "A61M 2025/0037",
    "A61M 2025/0681",
    "A61M 2205/3331",
    "A61M 2205/3368",
    "A61M 25/0029",
    "A61M 25/0045",
    "A61M 25/0071"
  ],
  "ipc": [
    "A61F 7/12",
    "A61M 25/14",
    "A61M 5/00",
    "A61B 18/02",
    "A61B 18/04",
    "A61M 25/00"
  ],
  "assignees": [
    "Nuvue Therapeutics Inc"
  ],
  "inventors": [
    "Patrick LePivert"
  ],
  "filing_date": "2010-04-22",
  "publication_date": "2010-10-28",
  "priority_date": "2007-07-30",
  "application_number": "US-76559310-A",
  "family_id": "42272682",
  "cited_by_count": 55,
  "citations": [
    "US3712306A",
    "US3786814A",
    "US4540404A",
    "US5281215A",
    "US5437673A",
    "US6033397A",
    "US6974463B2",
    "US6283959B1",
    "US6494844B1",
    "US6945942B2",
    "US6540694B1",
    "US6551255B2",
    "US7311672B2",
    "US20050222649A1",
    "US7128738B2",
    "US7402140B2",
    "US20060282039A1",
    "US20080119838A1"
  ]
}