Tissue Marking For Lesion Removal

• US 20170042633A1
• Filed: 08/09/2016
• Published: 02/16/2017
• Est. Priority Date: 06/07/2010
• Status: Abandoned Application

• Current Assignee: Malignext Targeting Technologies, Inc.
• Original Assignee: Malignext Targeting Technologies, Inc.
• Inventors: LeClaire, Jarrett, Khaw, Jamie
• Application Number:
  US15/231,781
• Publication Number:
  US 20170042633A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A preoperative tumor marking may be used to assist physicians in the removal of tumor tissue by clearly defining the margins of the tumor. An imaging technique, such as mammography, may be employed to visualize the tumor. The visualized tumor may be marked with a polymer, either directly or indirectly. The polymer may be liquid at room temperature and harden at body temperature, making the tumor palpable, but not changing the tumor'"'"'s cellular and physical state. The polymer may also include a coloring agent that may aid in visualizing the lesion. This will assist a surgeon during excision by allowing him/her to both feel and see the tumor and remove enough of the tissue surrounding the tumor to greatly reduce the need for a second surgical procedure due to a failure to remove all tumor tissue during an initial surgery.

Claims

1. A method of marking a cancerous lesion in a breast to provide a medical professional visual and tactile guidance to the cancerous lesion, the method comprising:

imaging the breast with mammography to identify a location of the cancerous lesion;

inserting a needle into the breast, a tip of the needle at the location of the cancerous lesion;

injecting liquid poly(N-isopropylacrylamide) cooled below a temperature of the breast through the needle into the breast;

removing the needle;

ceasing mammography; and

surgically removing the cancerous lesion from the breast by using the hardened poly(N-isopropylacrylamide) as a reference point.

2. A method comprising;

identification of a lesion in a patient through an imaging technique;

marking a location of the lesion during the imaging technique using a temperature responsive polymer injected through an epidermis directly into a tissue of the patient.

3. The method of claim 2, wherein the lesion comprises a cancerous tumor, breast tumor, ductal carcinoma in situ, invasive/infiltrating ductal carcinoma, invasive/infiltrating lobular carcinoma, lobular carcinoma in situ, or a recurrent breast cancer.

4. The method of claim 2, wherein the imaging technique comprises mammography, sonography, magnetic resonance imaging, breast specific gamma imaging, or thermography.

5. The method of claim 2, wherein the tissue comprises tissue surrounding the lesion.

6. The method of claim 2, wherein the tissue comprises tissue of the lesion.

7. The method of claim 2, wherein the temperature responsive polymer comprises a hydrogel.

8. The method of claim 7, wherein the hydrogel comprises poly(N-isopropylacrylamide) or a poloxamer.

9. The method of claim 2, wherein the polymer undergoes a phase change from a liquid phase to a solid phase when heated above a transition temperature.

10. The method of claim 9, wherein the transition temperature is about 37 degrees Celsius.

11. The method of claim 9, wherein the phase change comprises a reversible phase change.

12. The method of claim 9, wherein the polymer in the solid phase is palpable when within the tissue.

13. The method of claim 2, wherein a tissue property of the lesion remains the same following injection of the polymer.

14. The method of claim 2, wherein the method further comprises excision of the lesion.

15. The method of claim 14, wherein the method further comprises removing the polymer from the excised lesion by allowing the excised lesion to cool below a transition temperature so that the polymer liquefies and drains from the excised lesion.

16. A kit comprising:

a temperature responsive hydrogel;

a syringe; and

a needle for delivery of the hydrogel into a tissue of a patient.

17. The kit of claim 16, wherein the temperature responsive hydrogel comprises a poloxamer.

18. The kit of claim 16, wherein the syringe is at least partially insulated.

19. The kit of claim 16, wherein the needle is insulated.

20. The kit of claim 16, further comprising a temperature controlling device.