Apparatus for locating a breast mass

• US 4,966,583 A
• Filed: 02/03/1989
• Issued: 10/30/1990
• Est. Priority Date: 02/03/1989
• Status: Expired due to Term

• Current Assignee: Elie Debbas
• Original Assignee: Elie Debbas
• Inventors: Debbas, Elie
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/305,965
• Time in Patent Office: 634 Days
• Field of Search: 604/96, 604/103, 604/97, 604/98, 604/99, 604/100, 604/101, 604/102, 606/192, 606/193, 606/196, 606/197, 606/159, 606/185, 606/194, 128/753, 128/754
• US Class Current: 604/98.01
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3962 palpable
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A mass localization device includes a catheter and a needle. The catheter includes inner and outer walls spaced from each other and creating a gap between the walls extending along substantially the entire length of the catheter. The distal portion of the outer wall includes an inflatable balloon. A port extension member is provided at the proximal end of the catheter for communicating a supply of air to the inflatable balloon via the gap between the inner and outer walls of the catheter. The needle is insertable through the catheter to extend beyond the distal end of the catheter. In use, the combination of the needle and catheter are inserted into body tissue. Under assistance of x-ray radiography, the device is moved toward a mass in the tissue. Once proximate the mass, an anesthetizing agent is introduced to the tissue through the needle. Subsequently, the balloon is inflated for contacting the mass, and thus making the mass palpable. The needle is withdrawn from the catheter, and the patient is prepared for a biopsy or other medical procedure. An incision to the mass can be achieved by the shortest possible distance since the mass is made palpable.

Claims

1. An apparatus for localizing and palpating a mass in body tissue, said apparatus comprising:

a flexible catheter having an open proximal end and an open distal end;

an external sheathing surrounding said catheter and including an expandable balloon portion positioned at a distalmost portion of said distal end of said catheter, said balloon portion being expandable around said catheter at said distalmost portion of said catheter and being inflatable to have a diameter of about 2 to 5 cm at a mass located deeply in the body tissue so as to be palpable through the body tissue so that a direct incision may be made from the skin to the expanded balloon portion across the shortest distance possible for surgically locating the mass with a minimal length incision; and

a hollow needle having proximal and distal ends, said distal end being sharp, said needle being insertable through said proximal end of said catheter so that said distal end of said needle extends beyond said distal end of said catheter to deliver anaesthesia to an area adjacent to an x-ray identified mass so that said balloon may be inflated under anesthetized conditions to identify the location of the mass by feeling the location of the inflated balloon portion through the body tissue, with means for preventing the distal end of said needle from extending more than slightly beyond said distal end of said catheter.

2. The apparatus of claim 1, further comprising a supply of air connected to said catheter, and said balloon portion being expandable upon receiving air from said supply of air for identifying the mass in the body tissue.

3. The apparatus of claim 1, wherein said catheter includes an inner wall extending along the entire length of said catheter;

an outer wall forming said external sheathing and being spaced from said inner wall and extending along the entire length of said catheter, said inner wall and said outer wall being connected together at said distal end and proximal end of said catheter, said outer wall including a thickened portion to separate said outer wall into a proximal portion and a distal portion, said proximal portion having a thickness greater than a thickness of said distal portion, and said distal portion of said outer wall forming said expandable balloon portion; and

a gap formed between said inner wall and said outer wall extending along substantially the entire length of said catheter and communicating with said distal portion which forms said expandable balloon portion.

4. The apparatus of claim 3, further comprising a port extension member and a supply of air, said port extension member being connected to said catheter for communicating said supply of air to said distal portion which forms said expandable balloon portion via said gap between said inner wall and said outer wall.

5. The apparatus of claim 1, wherein the distal end and the proximal end of said needle are open.

6. An apparatus for localizing and palpating a mass in body tissue, said apparatus comprising:

a flexible catheter having an open proximal end and an open distal end, said catheter including an inner wall extending along the entire length of said catheter, and an outer wall spaced from said inner wall and extending along the entire length of said catheter, said inner wall and said outer wall being connected at said proximal end and said distal end of said catheter, a gap created between said inner wall and said outer wall extending substantially the entire length of said catheter, said outer wall including distinct proximal and distal portions, said distal portion being located at a distalmost end of said catheter and forming in inflatable balloon;

a needle having proximal and distal ends, said distal end being sharp, said needle being insertable through said proximal end of said catheter so that said distal end of said needle extends beyond said distal end of said catheter, with means for preventing said distal end of said needle from extending more than slightly beyond said distal end of said catheter;

a supply of air; and

a port extension means connected at said outer wall of said catheter for communicating said supply of air to said inflatable balloon via said gap between said inner and outer walls of said catheter, said inflatable balloon being expanded upon receiving air from said supply of air to identify the location of an x-ray located mass by positioning said catheter with said needle located therein adjacent to the mass in the body tissue, said inflatable balloon being inflatable to have a diameter of about 2 to 5 cm at a mass located deeply in the body tissue to be palpable through the body tissue upon expansion so that a direct incision may be made from the skin to the inflatable balloon across the shortest distance possible for surgically locating the mass with a minimal length incision.

7. The apparatus of claim 6, wherein said proximal portion of said outer wall has a first thickness, and said distal portion of said outer wall has a second thickness, said first thickness being greater than said second thickness for ensuring that said distal portion of said outer wall expands upon supply of air to said inflatable balloon.

8. The apparatus of claim 7, further comprising a thickened ring member at an interface of said proximal portion and said balloon of said outer wall for preventing said proximal portion from inflating with said balloon upon supply of air.