US20050004492A1 — Breast biopsy system and methods

Claim 1

Independent Claim 83 words

1 . A biopsy instrument for retrieving body tissue, having a longitudinal axis and comprising: an elongated tubular shaft having a proximal end and a distal end adapted for entry into a patient's body; and a cutting element disposed on elongated tubular shaft which is actuatable between a radially retracted position and a radially extended position, relative to the longitudinal axis, and which is rotatable in a radially extended position about the longitudinal axis to isolate a desired tissue specimen from surrounding tissue.

Claim 2

Dependent Claim 83 words

1 . A biopsy instrument for retrieving body tissue, having a longitudinal axis and comprising: an elongated tubular shaft having a proximal end and a distal end adapted for entry into a patient's body; and a cutting element disposed on elongated tubular shaft which is actuatable between a radially retracted position and a radially extended position, relative to the longitudinal axis, and which is rotatable in a radially extended position about the longitudinal axis to isolate a desired tissue specimen from surrounding tissue.

Claim 3

Dependent Claim 30 words

2 . The biopsy instrument as recited in claim 1 , wherein the cutting element is rotatable about the longitudinal axis in radially extended position to isolate desired tissue specimen.

Claim 4

Dependent Claim 29 words

3 . The biopsy instrument as recited in claim 1 , wherein said cutting element is movable axially in said radially extended position to isolate said desired tissue specimen.

Claim 5

Dependent Claim 32 words

4 . The biopsy instrument as recited in claim 1 , said distal end comprising an electrosurgical cutting element for cutting tissue and facilitating advancement of said instrument into the patient's body.

Claim 6

Dependent Claim 3 words

5 . (Cancelled)

Claim 7

Dependent Claim 3 words

5 . (Cancelled)

Claim 8

Dependent Claim 20 words

6 . The biopsy instrument as recited in claim 1 , wherein the cutting element is an electrosurgical cutting element.

Claim 9

Dependent Claim 20 words

7 . The biopsy instrument as recited in claim 6 , wherein the electrosurgical cutting element is a monopolar electrode.

Claim 10

Dependent Claim 20 words

8 . The biopsy instrument as recited in claim 6 , wherein the electrosurgical cutting element is a bipolar electrode.

Claim 11

Dependent Claim 22 words

9 . The biopsy instrument as recited in claim 8 , wherein a portion of said shaft has a return bipolar electrode.

Claim 12

Dependent Claim 31 words

10 . The biopsy instrument as recited in claim 1 , including a sheath which is axially movable between distal and proximal positions for selectively covering and uncovering the cutting element.

Claim 13

Dependent Claim 26 words

11 . The biopsy instrument as recited in 1 , including a proximal driver unit for controlling radial expansion and retraction of the cutting element rotation.

Claim 14

Dependent Claim 26 words

11 . The biopsy instrument as recited in 1 , including a proximal driver unit for controlling radial expansion and retraction of the cutting element rotation.

Claim 15

Dependent Claim 24 words

12 . The biopsy instrument as recited in claim 1 , wherein a proximal driver unit for controlling axial movement of the shaft sheath.

Claim 16

Dependent Claim 31 words

13 . The biopsy instrument as recited in claim 1 , wherein the cutting element is configured to segment the tissue specimen after it has been isolated from the surrounding tissue.

Claim 17

Dependent Claim 38 words

14 . The biopsy instrument as recited in claim 1 , wherein the cutting element is configured to segment the tissue specimen as the cutting element is retracted from the radially extended position to the radially retracted position.

Claim 18

Dependent Claim 36 words

15 . The biopsy instrument as recited in claim 14 , wherein the cutting element is configured to be rotatable about the axis from a plurality of radially extended positions to selectively peripherally segment the tissue.

Claim 19

Dependent Claim 31 words

16 . The biopsy instrument as recited in claim 13 , including a cannula having a lumen for removing one or more segments of the tissue specimen from the patient's body.

Claim 20

Dependent Claim 20 words

17 . The biopsy instrument as recited in claim 1 , including a tissue collection component for encapsulating the tissue.

Claim 21

Dependent Claim 39 words

18 . The biopsy instrument as recited in claim 17 , wherein the tissue collection component is a band which is disposed along said shaft and which is actuatable between a radially retracted position and a radially extended position.

Claim 22

Dependent Claim 39 words

19 . The biopsy instrument as recited in claim 17 , wherein the tissue collection component is a plurality of bands which are disposed along the shaft and which are actuatable between radially retracted positions and radially extended positions.

Claim 23

Dependent Claim 5 words

20 - 28 . (Cancelled)

Claim 24

Dependent Claim 5 words

20 - 28 . (Cancelled)

Claim 25

Dependent Claim 126 words

29 . A method for severing a tissue specimen from a tissue site within a patient's body and retrieving the severed tissue specimen from a the tissue site, comprising: a. providing an elongated biopsy device having a distal end, a longitudinal axis, and an axially disposed cutting element; b. advancing the elongated biopsy device into the patient's body, so that the distal end is disposed in the tissue site from which the tissue specimen is to be taken; c. bowing the cutting element radially outwardly from the longitudinal axis of the biopsy device; d. rotating the cutting element about the longitudinal axis to sever the tissue specimen from the tissue site; and e. collecting the tissue severed by the cutting element in a tissue collection device.

Claim 26

Dependent Claim 126 words

29 . A method for severing a tissue specimen from a tissue site within a patient's body and retrieving the severed tissue specimen from a the tissue site, comprising: a. providing an elongated biopsy device having a distal end, a longitudinal axis, and an axially disposed cutting element; b. advancing the elongated biopsy device into the patient's body, so that the distal end is disposed in the tissue site from which the tissue specimen is to be taken; c. bowing the cutting element radially outwardly from the longitudinal axis of the biopsy device; d. rotating the cutting element about the longitudinal axis to sever the tissue specimen from the tissue site; and e. collecting the tissue severed by the cutting element in a tissue collection device.

Claim 27

Dependent Claim 21 words

30 . The method as recited in claim 29 , wherein the tissue specimen is collected by encapsulating the tissue specimen.

Claim 28

Dependent Claim 56 words

31 . The method as recited in claim 30 , wherein the encapsulation includes radially expanding at least one encapsulating element so that a portion thereof is radially outwardly spaced from the axis of said instrument and rotating biopsy device about its longitudinal axis so that said at least one encapsulating element encloses the tissue specimen.

Claim 29

Dependent Claim 29 words

32 . The method as recited in claim 31 , wherein said at least one encapsulating element comprises a plurality of bands which are disposed axially along said instrument.

Claim 30

Dependent Claim 3 words

33 . Cancelled

Claim 31

Dependent Claim 3 words

33 . Cancelled

Claim 32

Dependent Claim 20 words

34 . The method as recited in claim 29 , and further comprising the step of segmenting said tissue specimen.

Claim 33

Dependent Claim 27 words

35 . The method as recited in claim 34 , and further comprising the step of withdrawing each segment of said tissue specimen through a cannula lumen.

Claim 34

Dependent Claim 35 words

36 . The method as recited in claim 34 , wherein the step of segmenting said tissue specimen includes the step of radially retracting said cutting element so that the tissue specimen is segmented radially.

Claim 35

Dependent Claim 51 words

37 . The method as recited in claim 34 , wherein the step of segmenting said tissue specimen includes the steps of partially radially retracting said cutting element from its fully radially expanded position and rotating the instrument about its axis to cut said tissue and create a circumferential tissue segment.

Claim 36

Dependent Claim 36 words

38 . The method as recited in claim 37 , wherein the segmenting step is repeated at differing partially radially expanded positions of the cutting element, so that a plurality of circumferential tissue segments are created.

Claim 37

Dependent Claim 33 words

39 . The method as recited in claim 29 , and further comprising the step of simultaneously moving the cutting element axially as it is rotated about said axis to cut said tissue.

Claim 38

Dependent Claim 25 words

40 . The biopsy instrument of claim 10 including a proximal driver unit for controlling the rotation of the cutting element about the longitudinal axis.

Claim 39

Dependent Claim 20 words

41 . The biopsy instrument of claim 10 including a proximal driver unit for controlling axial movement of the sheath.

Claim 40

Dependent Claim 27 words

42 . The biopsy instrument of claim 17 , wherein tissue collection component is configured to withdraw the specimen from the patient's body as a single unit.

Claim 41

Dependent Claim 89 words

43 . An instrument assembly for isolating a tissue specimen from an intracorporeal site, comprising: a. an elongate shaft which has a longitudinal axis and a distal end; b. an electrosurgical tissue cutting component which is radially extendable from a retracted position to an extended position and which is configured to electrosurgically isolate a desired tissue specimen from surrounding tissue at the site; and c. a tissue collection component coupled to the shaft which is configured to encapsulate the isolated tissue specimen from the surrounding tissue at the site.

Claim 42

Dependent Claim 89 words

43 . An instrument assembly for isolating a tissue specimen from an intracorporeal site, comprising: a. an elongate shaft which has a longitudinal axis and a distal end; b. an electrosurgical tissue cutting component which is radially extendable from a retracted position to an extended position and which is configured to electrosurgically isolate a desired tissue specimen from surrounding tissue at the site; and c. a tissue collection component coupled to the shaft which is configured to encapsulate the isolated tissue specimen from the surrounding tissue at the site.

Claim 43

Dependent Claim 22 words

44 . The instrument assembly of claim 43 wherein the tissue collection component is configured to maintain the encapsulated tissue specimen intact.

Claim 44

Dependent Claim 28 words

45 . The instrument assembly of claim 43 wherein the tissue cutting component is longitudinally disposed on the elongate shaft proximal of the distal end of the shaft.

Claim 45

Dependent Claim 36 words

46 . The instrument assembly of claim 43 wherein the tissue cutting component is configured to be rotated at least in part about the longitudinal axis in the radially extended position to isolate the tissue specimen.

Claim 46

Dependent Claim 28 words

47 . The instrument assembly of claim 46 wherein both the cutting component and the tissue collection component are movable from a retracted position to an expanded position.

Claim 47

Dependent Claim 79 words

48 . An excisional device for cutting and removing a specimen of breast tissue, comprising: a shaft; a tissue cutting component coupled to the shaft and configured to cut the specimen of breast tissue from surrounding breast tissue; a tissue collection component coupled to the shaft which is configured to encapsulate the cut specimen and maintain the encapsulated specimen intact, both the cutting component and the tissue collection component being movable from a retracted position to an expanded position.

Claim 48

Dependent Claim 79 words

48 . An excisional device for cutting and removing a specimen of breast tissue, comprising: a shaft; a tissue cutting component coupled to the shaft and configured to cut the specimen of breast tissue from surrounding breast tissue; a tissue collection component coupled to the shaft which is configured to encapsulate the cut specimen and maintain the encapsulated specimen intact, both the cutting component and the tissue collection component being movable from a retracted position to an expanded position.

Claim 49

Dependent Claim 50 words

49 . The instrument assembly of claim 48 wherein at least one tissue collection component has a proximal end and a distal end and which is configured to move one end closer to the other end to effect radial extension from the retracted position to the radial extended arcuate position.

Claim 50

Dependent Claim 31 words

50 . The instrument assembly of claim 48 wherein the tissue collection component is configured so that the distal end is fixed and the proximal end move toward the distal end.

Claim 51

Dependent Claim 26 words

51 . The instrument assembly of claim 48 , wherein the tissue collection component and the tissue cutting component are configured to expand and retract together.

Claim 52

Dependent Claim 127 words

52 . An instrument for encapsulating and removing a tissue specimen from a patient's body, comprising: a. an elongate shaft which has a distal end a longitudinal axis b. a tissue cutting component which is disposed on a distal portion of the elongate shaft, which is radially extendable from a retracted position to an extended position, relative to the longitudinal axis, which has an arcuate shape in the extended position and which is movable in the radially extended position about the longitudinal axis to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen; and c. an encapsulation component for encapsulating the tissue specimen after it has been isolated from surrounding tissue and removing it from the patient's body intact.

Claim 53

Dependent Claim 127 words

52 . An instrument for encapsulating and removing a tissue specimen from a patient's body, comprising: a. an elongate shaft which has a distal end a longitudinal axis b. a tissue cutting component which is disposed on a distal portion of the elongate shaft, which is radially extendable from a retracted position to an extended position, relative to the longitudinal axis, which has an arcuate shape in the extended position and which is movable in the radially extended position about the longitudinal axis to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen; and c. an encapsulation component for encapsulating the tissue specimen after it has been isolated from surrounding tissue and removing it from the patient's body intact.

Claim 54

Dependent Claim 39 words

53 . The instrument of claim 52 wherein the instrument has a distal tissue cutting element with a linear cutting surface disposed on the distal end of the shaft to facilitate accessing the tissue specimen within the patient's body.

Claim 55

Dependent Claim 30 words

54 . The instrument of claim 52 , wherein the encapsulation component has a plurality of encapsulation elements which are radially extendable from a retracted position to an extended position.

Claim 56

Dependent Claim 91 words

55 . An excisional biopsy method for soft tissue: a. inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and a tissue collection device near a distal tip of the tubular member; b. rotating the cutting tool; c. selectively varying a degree of bowing of the cutting tool away from the tubular member; d. collecting tissue severed by the cutting tool in the tissue collection device; and e. retracting the tubular member from the soft tissue.

Claim 57

Dependent Claim 91 words

55 . An excisional biopsy method for soft tissue: a. inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and a tissue collection device near a distal tip of the tubular member; b. rotating the cutting tool; c. selectively varying a degree of bowing of the cutting tool away from the tubular member; d. collecting tissue severed by the cutting tool in the tissue collection device; and e. retracting the tubular member from the soft tissue.

Claim 58

Dependent Claim 32 words

56 . The method of claim 55 , further comprising the step of controlling the cutting tool to assume a non-extended state prior to the inserting step and before the retraction step.

Claim 59

Dependent Claim 35 words

57 . The method of claim 55 , wherein the extension of the cutting tool is controlled by pushing and retracting a proximal end of the cutting tool in the distal and proximal directions, respectively.

Breast biopsy system and methods

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