Breast surgery method and apparatus

• US 6,280,450 B1
• Filed: 07/23/1998
• Issued: 08/28/2001
• Est. Priority Date: 07/24/1997
• Status: Expired due to Term

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/122,185
• Time in Patent Office: 1,132 Days
• Field of Search: 606/37, 606/39, 606/40, 606/108, 606/110, 606/113, 606/114, 606/130, 606/170, 606/180, 606/171
• US Class Current: 606/114
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/008 Removal of tumors
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2017/320074 blade
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An apparatus and method for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than a maximum transverse dimension of the tissue mass excised. The apparatus includes an axially elongated housing, tissue piercing means slidable within the housing and radially expandable members for cutting a conical swath having a radius greater than the maximum transverse dimension of the elongated housing and greater than the maximum transverse cross-sectional dimension of the target tissue mass to separate the target tissue mass from surrounding tissue. An expandable member is slidably advancable to bag the target tissue mass for aseptic removal via the elongated housing.

Claims

1. Apparatus for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised, comprising:

a. an axially elongated housing;

b. tissue piercing means slidably resident within said housing;

c. means connected to said elongated housing and being resiliently radially expandable relative thereto for cutting a conical swath having radius greater than maximum transverse dimension of said elongated housing and greater than maximum transverse cross-sectional dimension of said target tissue mass to separate said target tissue mass from surrounding tissue for excision thereof through said incision.

2. Apparatus of claim 1 further comprising:

a. expandable means within said elongated housing, axially slidably advanceable and radially expandable through said conical swath to collectably bag said target tissue mass for aseptic removal in an axial direction via said elongated housing through said incision.

3. Apparatus of claim 2 further comprising:

a. a sheath axially slidably resident within and concentric with said elongated housing for applying radially inward force on said target tissue mass bagging means and any target tissue mass contained therewithin prior to removal thereof from said subcutaneous tissue via said housing.

4. Apparatus of claim 3 further comprising drawstring means for closing said bagging means about any target tissue mass contained therewithin by radially inward movement of a circular periphery of said bag means.

5. Apparatus of claim 1 wherein at least a portion of of said tissue piercing means of said apparatus is detectable fluoroscopically.

6. Apparatus of claim 1 wherein at least a portion of said tissue piercing means of said apparatus is detectable ultrasonically.

7. Apparatus of claim 1 wherein at least a portion of said tissue piercing means of said apparatus is detectable using mammographic x-ray.

8. Apparatus of claim 1 wherein at least a portion of said tissue piercing means of said apparatus is detectable tomographically.

9. Apparatus of claim 1 further comprising

a. means for electrically heating said cutting means for cauterizingly cutting to detach the target tissue mass from surrounding tissue.

10. Apparatus of claim 9 further comprising

a. means for electrically energizing said cutting means for coagulating tissue around said target tissue mass during cutting.

11. Apparatus of claim 1 wherein said cutting means comprises a laser.

12. Apparatus of claim 1 wherein said cutting means comprises wire.

13. A method for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised, comprising:

a. advancing tissue piercing means towards a patient to create an incision in the patient'"'"'s skin;

b. slidably advancing cutting means through said incision and into sub-cutaneous tissue until in position to radially expand and cut a conical swath around said target tissue mass larger than said incision;

c. cutting a conical swath around said target tissue mass thereby separating said target tissue mass from said surrounding tissue;

d. slidably advancing flexible aseptic containment means over said separated target tissue mass to a position of closure around said target tissue mass;

e. withdrawing said flexible aseptic containment means with said target tissue mass aseptically contained therewithin through said incision.

14. The method of claim 13 further comprising radially inwardly collapsing said cutting means after cutting said swath.

15. The method of claim 13 further comprising fluoroscopically guiding said tissue piercing means through said incision and into sub-cutaneous tissue until said cutting means is in position to cut said swath around said target tissue mass.

16. The method of claim 13 further comprising ultrasonographically guiding said tissue piercing means through said incision and into sub-cutaneous tissue until said cutting means is in position to cut said swath around said target tissue mass.

17. The method of claim 13 further comprising x-ray mammographically guiding said tissue piercing means through said incision and into sub-cutaneous tissue until said cutting means is in position to cut said swath around said target tissue mass.

18. The method of claim 13 further comprising computer-aided tomographically guiding said tissue piercing means through said incision and into sub-cutaneous tissue until said cutting means is in position to cut said swath around said target tissue mass.

19. The method of claim 13 wherein said cutting means is a laser.

20. The method of claim 13 wherein said cutting means includes a blade.

21. The method of claim 13 wherein said cutting means includes a cutting wire.

22. The method of claim 13 wherein said cutting means is cryogenic.

23. The method of claim 13 wherein said cutting means utilizes radiofrequency wave energy.

24. The method of claim 13 wherein said cutting means utilizes chemical ablation.

25. Apparatus for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised, comprising:

a. an axially elongated containment sheath having a resiliently expandable portion at one end thereof;

b. means insertable through said containment sheath for making said cutaneous incision;

c. a plurality of axially elongated support members insertable through said incision and said containment sheath and said incision into sub-cutaneous tissue, said support members being connected at their proximate ends, distal ends of said support members being unconnected to define a conical penumbra within said subcutaneous tissue;

d. means for resiliently expanding said support members into said conical penumbra-defining orientation;

e. a support catheter resident within and insertable through said containment sheath;

f. a tissue cutting wire loop slidable resident within said support catheter in said containment sheath adapted for gradual exit from said support catheter to axially circumferentially traverse the slant surface of said conical penumbra;

g. a tissue containment bag insertable through said containment sheath and along said support members to reach the base of said conical penumbra, said bag including;

i. at least one drawstring threaded through the periphery of said bag at said conical penumbra for closing said bag about resected target tissue.

26. A method for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised, comprising:

a. advancing tissue piercing means through a containment sheath having an expandable potion towards a patient to create an incision in the patient'"'"'s skin;

b. slidably advancing support members through said incision and said containment sheath into sub-cutaneous tissue until the target tissue mass is within a conical penumbra defined by said support members;

c. simultaneously;

i. axially advancing a tissue cutting loop of hot wire through a support catheter in said containment sheath respecting said cone circumferentially around the slant surface of said conical penumbra;

while

ii. advancing additional loop length out of said catheter within said containment sheath to provide sufficient length for said loop to extend in circular fashion around the circumference of said cone on said slant surface parallel to the cone base;

while

iii. advancing said support catheter through said containment sheath along the slant surface of said conical penumbra to maintain the outlet of said support catheter via which said loop is advanced adjacent to said loop at any location along said slant surface of said cone;

 

until said tissue cutting loop reaches the cone base;

d. while maintaining said catheter outlet at said cone base drawing said wire into said catheter resident in said containment sheath to eliminate the loop and cut through tissue in the shape of a cone base;

e. withdrawing said catheter and the enclosed wire from the patient through said containment sheath;

f. sliding a tissue containment bag through said containment sheath and along said conical support to reach the base of said cone;

g. pulling drawstrings threaded through the periphery of said bag at said cone base through said containment sheath to close said bag about said previously resected specimen;

h. pulling said bag with said resected specimen therewithin into said expandable portion of said containment sheath thereby causing said sheath to expand and compress said specimen within said bag to smaller size;

i. continuing pulling said bag with said compressed specimen therewithin through the remainder of said containment sheath and out of said patient.

27. A surgical apparatus for cutting a tissue mass comprising:

an elongated housing

first and second support members positioned within the elongated housing and movable from within the housing to a radially diverged position outside the housing, a distance between a tip of the first support member and a tip of the second support member being greater than a diameter of the housing in the radially diverged position; and

an electrocautery wire for cutting the tissue, the electrocautery wire positioned within the elongated housing and advancable from the housing along the support members to a position to cut the tissue mass.

28. The apparatus of claim 27, further comprising a tissue containment bag positioned within the elongated housing and advancable from the elongated housing along the support members to contain and remove the cut tissue.

29. The apparatus of claim 27, wherein the support members radially diverge from the elongated housing to form a conical penumbra.

30. The apparatus of claim 29, wherein the electrocautery wire is advanced over an outer periphery of the support members and a loop formed by the wire is enlarged as the wire advances over the support members, the wire advancing to a position at a base of the conical penumbra.

31. A surgical apparatus comprising:

an elongated housing;

first and second support members positioned within the elongated housing and movable from within the housing to a radially diverged position outside the housing, a tip of the first and second support members extending past the target tissue mass; and

a tissue containment bag positioned within the elongated housing and advancable from the elongated housing along an outer periphery of the support members to remove cut tissue, the tissue containment bag enlarged as it is advanced along the support members.

32. The apparatus of claim 31, further comprising an electrocautery wire advancable along the support members prior to advancement of the containment bag.

33. A method for excising a tissue mass comprising:

inserting an elongated housing through an incision into tissue adjacent a target tissue mass;

advancing first and second support members from the housing to radially diverge with respect to each other and to diverge from the target tissue mass to create a penumbra larger than a diameter of the housing, a tip of the first and second support members extending past the target tissue mass;

advancing an electrocautery wire loop over the diverged support members so the wire loop expands in diameter to a diameter exceeding the diameter of the elongated housing; and

electrically energizing the wire loop.

34. The method of claim 33, further comprising the step of advancing a tissue containment bag over the radially diverged support members to expand the bag.

35. The method of claim 34, wherein the step of advancing the support members to create a penumbra forms a conically shape penumbra and the step of advancing the electrocautery wire advances the wire to a base of the conical penumbra.

36. The method of claim 35, further comprising the step of pulling a drawstring to tighten the tissue containment bag.