Breast stabilization devices and methods

• US 6,146,377 A
• Filed: 09/22/1998
• Issued: 11/14/2000
• Est. Priority Date: 09/22/1998
• Status: Expired due to Term

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Vetter, James W., Lee, Roberta, Hyland, Natalie N.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/158,215
• Time in Patent Office: 784 Days
• Field of Search: 606/1, 606/130, 600/38, 600/411, 600/414
• US Class Current: 606/13
• CPC Class Codes: A61B 8/0825 for diagnosis of the breast, e.g. mammography
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices

Abstract

A breast stabilization device includes a substantially rigid outer member and an inner member joined to the outer member. The inner member is configured to conform to the shape of the female breast. An opening is disposed through the outer and inner members, the opening being centered on the nipple/areolar complex of the breast and exposing at least a portion of the areola surrounding the nipple. A rigid rim may surround the periphery of the opening and may rise above the surface of the outer member. The device stabilizes the breast in an uncompressed or slightly expanded state to allow interventional and imaging procedures to be carried out without compressing the breast. The opening allows access to the breast through the areola and the rim allows one or more instruments to be attached thereto. A method of imaging a breast, according to the present invention, includes the steps of placing a generally breast shaped member on the breast, the breast shaped member having one or more imaging port therein; expanding the breast to come into intimate contact with the breast shaped member; and imaging the breast through the imaging port(s). The imaging step may be carried out by directing ultrasonic energy through the port(s).

Claims

1. A breast stabilization device for imaging and invasive procedures, comprising:

a substantially rigid outer member;

an inner member joined to the outer member, the inner member being configured to generally conform to a shape of a female breast;

an opening disposed through the outer and inner members, the opening being adapted to align with a nipple/areola complex of the breast, and

at least one imaging port disposed within a side surface of at least the outer member.

2. The device of claim 1, further comprising a rigid rim surrounding a periphery of the opening and rising above a surface of the outer member.

3. The device of claim 2, wherein the rigid rim includes a lip configured to allow at least one instrument to be secured thereto.

4. The device of claim 2, wherein the rim is integral to the outer member.

5. The device of claim 1, wherein the opening is configured to expose at least a portion of an areola surrounding the nipple.

6. The device of claim 1, wherein at least the inner member comprises a curved base portion configured to support the device against a patient'"'"'s chest.

7. The device of claim 6, wherein the base portion comprises a second sealing edge, the second sealing edge being configured to seal the device to the patient'"'"'s chest.

8. The device of claim 7, wherein the second sealing edge includes a second adhesive layer disposed thereon.

9. The device of claim 1, further comprising a first sealing edge around the opening, the first sealing edge being configured to seal the breast to the opening.

10. The device of claim 9, wherein the first sealing edge includes a first adhesive layer disposed thereon.

11. The device of claim 1, further comprising an imaging port rim adapted to fit within the imaging port, the imaging port rim allowing at least one imaging instrument to be secured thereto.

12. The device of claim 11, further comprising an imaging port sealing edge surrounding each of the at least one imaging port, each imaging port sealing edge being configured to seal the breast around its corresponding imaging port.

13. The device of claim 1, wherein the inner member includes an inner member adhesive layer disposed on a surface thereof facing the breast.

14. The device of claim 1, wherein the inner member includes a plurality of through holes disposed therein.

15. The device of claim 14, wherein the inner member and the outer member are configured to form a substantially gas-tight interstitial space therebetween and wherein the device further comprises at least one suction port disposed in the outer member.

16. The device of claim 1, further comprising securing means attached to the outer member, the being adapted to secure means securing the breast stabilization device to at least one of a table and a chair.

17. The device of claim 16, wherein the securing means includes a substantially rigid band girdling the breast stabilizing device.

18. The device of claim 1, wherein the inner member is relatively more flexible than the outer member.

19. A procedure facilitating platform for a breast, comprising:

a generally breast shaped member configured to cover at least a portion of the breast;

suction means for drawing the breast shaped member in close contact with the breast;

an access port disposed in the generally breast shaped member, and

at least one imaging port, the at least one imaging port being disposed in a side of the generally breast shaped member.

20. The procedure facilitating platform of claim 19, wherein the first access port is adapted to be centered on the nipple/areolar complex of the breast when the platform is in use.

21. A method of imaging a breast, comprising the steps of:

placing a generally breast shaped member on the breast, the breast shaped member having a first imaging port therein;

expanding the breast to come into intimate contact with the breast shaped member; and

imaging the breast through the first imaging port.

22. The method of claim 21, wherein the expanding step is carried out by creating a partial vacuum between the breast and the breast shaped member.

23. The method of claim 21, wherein the first imaging port exposes a portion of the breast therethrough and the imaging step includes a step of directing ultrasonic energy into the breast through the first imaging port.

24. The method of claim 23, further comprising the step of applying an ultrasound coupling medium within the first imaging port prior to the directing step.

25. The method of claim 21, wherein the breast shaped member includes a second imaging port and wherein the imaging step images the breast through the first and the second imaging ports.

26. The method of claim 25, wherein the breast is imaged through the first and second imaging ports simultaneously.

27. The method of claim 26, further including the steps of:

processing imaging data obtained from each of the first and second imaging ports in a data processing and display device; and

displaying the processed image data as one of a real time and near real time representation of the breast.

28. The method of claim 21, wherein the imaging step generates imaging data and wherein the imaging data is transmitted to at least one data processing and display device.

29. A breast stabilization device for imaging and invasive procedures, comprising:

a substantially rigid outer member;

an inner member joined to the outer member, the inner member being configured to generally conform to a shape of a female breast and comprising a curved base portion configured to support the device against a patient'"'"'s chest, the curved base portion comprising a sealing edge that is configured to seal the device to the patient'"'"'s chest, and

an opening disposed through the outer and inner members, the opening being adapted to align with a nipple/areola complex of the breast.

30. A breast stabilization device for imaging and invasive procedures, comprising:

a substantially rigid outer member;

an inner member joined to the outer member, the inner member being configured to generally conform to a shape of a female breast and including a plurality of through holes disposed therein, the inner member and the outer member being adapted to form a substantially gas-tight interstitial space therebetween when the device is applied to the breast;

an opening disposed through the outer and inner members, the opening being adapted to align with a nipple/areola complex of the breast, and

at least one suction port disposed in the outer member.

31. A breast stabilization device for imaging and invasive procedures, comprising:

a substantially rigid outer member;

an inner member joined to the outer member, the inner member being configured to generally conform to a shape of a female breast;

an opening disposed through the outer and inner members, the opening being adapted to align with a nipple/areola complex of the breast, and

securing means attached to the outer member, the securing means being adapted to secure the breast stabilization device to at least one of a table and a chair.

32. The device of claim 31, wherein the securing means includes a substantially rigid band girdling the breast stabilizing device.

33. A method of stabilizing an uncompressed breast, comprising the steps of:

placing a generally breast-shaped member over the uncompressed breast, the breast-shaped member including an opening aligned with and exposing at least a portion of a nipple/areolar complex of the breast; and

sealing the breast within the shaped--shaped member by means of at least one of an adhesive and a vacuum-induced force that draws the breast thereto.

34. The method of claim 33, further comprising the step of:

securing the cup-shaped member to a stable positional reference structure.