Biopsy system for enhanced tissue harvesting

Patent metadata

Field	Value
Publication number	US-11607205-B2
Application number	US-201916559402-A
Country	US
Kind code	B2
Filing date	Sep 3, 2019
Priority date	Mar 3, 2017
Publication date	Mar 21, 2023
Grant date	Mar 21, 2023

Abstract

A biopsy system for harvesting larger volumes of tissue as compared to standard core biopsy needles. The system has a needle with a lumen, an aperture disposed at the distal end of the needle and connected to the lumen, and a cutting mechanism adapted to cut tissue. When the needle is rotated after it is inserted into a target tissue, the cutting mechanism cuts from the tissue and directs the cut tissue portions into the lumen. Multi-bioimpedance measurements are used to guide a needle and direct the application of electricity for cauterizing tissue.

First claim

What is claimed is:

1. A biopsy system ( 100 ) for harvesting a target tissue, comprising:
a. a needle ( 101 ) having a tip ( 103 ) disposed at a distal end of the needle ( 101 ) for insertion into tissue, wherein a lumen ( 106 ) is disposed in the needle ( 101 );
b. an aperture ( 102 ) disposed at or near the distal end of the needle, said aperture ( 102 ) fluidly connected to the lumen ( 106 ); and
c. a cutting mechanism ( 104 ) comprising an expandable dome-shape, semispherical structure having an edge adapted to cut tissue, said cutting mechanism ( 104 ) having at least a portion thereof disposed in or over the aperture ( 102 );
d. a sheath ( 105 ) slidably disposed around an exterior surface of the needle ( 101 ), the sheath ( 105 ) adapted to move between at least an open position where the aperture ( 102 ) and cutting mechanism ( 104 ) are exposed, and a closed position where the aperture ( 102 ) and cutting mechanism ( 104 ) are covered by the sheath ( 105 );
e. a sealing mechanism for cauterizing tissue that contacts said sealing mechanism, coagulating said tissue, or a combination thereof; and
f. a mechanism for rotating the needle;
wherein when the needle ( 101 ) is inserted into the target tissue, the sheath ( 105 ) deployed in the open position, and the needle ( 101 ) rotated via the rotation mechanism, the cutting mechanism ( 104 ) cuts the tissue and directs said cut tissue into the aperture ( 102 ) and further into the lumen ( 106 ), while contacting tissue is sealed by the sealing mechanism.

2. The system ( 100 ) of claim 1 , wherein the cutting mechanism ( 104 ) is deployable, said deployable cutting mechanism ( 104 ) having at least a portion thereof disposed in or over the aperture ( 102 ), said deployable cutting mechanism ( 104 ) adapted to move between an extended position where said portion projects from the needle ( 101 ), and a retracted position ( 120 ) where said portion is not projecting from the aperture ( 102 ), wherein when the needle ( 101 ) is inserted into the target tissue and the sheath ( 105 ) is moved to the open position, the deployable cutting mechanism ( 104 ) projects out from the aperture ( 102 ) and into the extended position.

3. The system ( 100 ) of claim 1 , wherein the needle tip ( 103 ) or cutting mechanism ( 104 ) is removable from the needle, wherein the removed tip or cutting mechanism is adapted to function as a tissue biopsy marker or wire localizer for indicating a location of the biopsied tissue.

4. The system ( 100 ) of claim 1 , wherein a gear ( 113 ) is operatively coupled to the sheath ( 105 ) and a motor for moving the sheath between the open position and the closed position.

5. The system ( 100 ) of claim 1 , wherein the lumen ( 106 ) is under negative pressure to allow the cut tissue to collect in the lumen ( 106 ), wherein the negative pressure in the lumen is generated using suction or a vacuum source.

6. The system ( 100 ) of claim 1 , wherein the sealing mechanism is an electrocautery system operatively connected to the cutting mechanism ( 104 ), wherein when the electrocautery system is activated, and the cutting mechanism ( 104 ) is activated to provide cauterization to contacting tissue.

7. The system ( 100 ) of claim 1 , wherein the sealing mechanism comprises a cauterizing surface, wherein the cauterizing surface is the needle tip ( 103 ) which acts as an exposed anode, and a shaft of the needle acts as a cathode, wherein the cauterizing mechanism further comprises an insulator that protects the cut tissue from being cauterized.

8. The system ( 100 ) of claim 1 further comprising at least one additional lumen ( 106 ) for holding or administering a solution.

9. The system ( 100 ) of claim 1 further comprising a tissue collection chamber fluidly coupled to the needle lumen ( 106 ) for storing the cut tissue.

10. The system ( 100 ) of claim 1 further comprising a plurality of electrodes ( 164 ) disposed on a surface of the sheath, on the needle, or both, wherein the plurality of electrodes is configured to apply electrical current for cauterizing tissue, coagulating blood, obtaining multiple bio-impedance measurements to guide needle insertion and positioning, or initiating electron-dependent biochemical processes.

11. A method of harvesting tissue, said method comprising:
a. providing a biopsy system ( 100 ) according to claim 1 ;
b. inserting the needle ( 101 ), starting with the tip ( 103 ), into a tissue of concern;
c. retracting the sheath ( 105 ) to expose the cutting mechanism ( 104 );
d. rotating the needle ( 101 ) and applying suction to the lumen, thereby cutting the tissue with the cutting mechanism ( 104 ) and sealing contacting tissue via the sealing mechanism, wherein the cut tissue is directed into the lumen ( 150 ).

12. A biopsy system ( 100 ) for harvesting a target tissue, comprising:
a. a needle ( 101 ) having a tip ( 103 ) disposed at a distal end of the needle ( 101 ) for insertion into tissue, wherein a lumen ( 106 ) is disposed in the needle ( 101 );
b. an aperture ( 102 ) disposed at or near the distal end of the needle, said aperture ( 102 ) fluidly connected to the lumen ( 106 ); and
c. a cutting mechanism ( 104 ) comprising an expandable semisphere-shape structure having an edge adapted to cut tissue, said cutting mechanism ( 104 ) having at least a portion thereof disposed in or over the aperture ( 102 );
d. a sheath ( 105 ) slidably disposed around an exterior surface of the needle ( 101 ), the sheath ( 105 ) adapted to move between at least an open position where the aperture ( 102 ) and cutting mechanism ( 104 ) are exposed, and a closed position where the aperture ( 102 ) and cutting mechanism ( 104 ) are covered by the sheath ( 105 );
e. a sealing mechanism for cauterizing tissue that contacts said sealing mechanism, coagulating said tissue, or a combination thereof;
f. a mechanism for rotating the needle; and
g. a mechanism for retracting the needle;
wherein when harvesting the target tissue, the needle ( 101 ) is inserted into the target tissue, the sheath ( 105 ) is deployed in the open position, the needle ( 101 ) is rotated via the rotation mechanism and simultaneously retracted via the retraction mechanism, wherein as the needle is rotating and simultaneously being retracted, the cutting mechanism ( 104 ) cuts the tissue and directs said cut tissue into the aperture ( 102 ) and further into the lumen ( 106 ), while contacting tissue is sealed by the sealing mechanism.

13. A biopsy system ( 100 ) for harvesting a target tissue, comprising:
a. a needle ( 101 ) having a tip ( 103 ) disposed at a distal end of the needle ( 101 ) for insertion into tissue, wherein a lumen ( 106 ) is disposed in the needle ( 101 );
b. an aperture ( 102 ) disposed at or near the distal end of the needle, said aperture ( 102 ) fluidly connected to the lumen ( 106 ); and
c. a cutting mechanism ( 104 ) adapted to cut tissue, said cutting mechanism ( 104 ) having at least a portion thereof disposed in or over the aperture ( 102 );
d. a sheath ( 105 ) slidably disposed around an exterior surface of the needle ( 101 ), the sheath ( 105 ) adapted to move between at least an open position where the aperture ( 102 ) and cutting mechanism ( 104 ) are exposed, and a closed position where the aperture ( 102 ) and cutting mechanism ( 104 ) are covered by the sheath ( 105 );
e. a sealing mechanism for cauterizing tissue that contacts said sealing mechanism, coagulating said tissue, or a combination thereof;
f. a mechanism for rotating the needle; and
g. a mechanism for retracting the needle;
wherein when harvesting the target tissue, the needle ( 101 ) is insert

Assignees

• Univ Arizona
• Banner Univ Medical Group
• Data Driven Diagnostic Sciences Inc

Inventors

• Larson Michael C
• Hennemeyer Charles T

Classifications

• A61B10/02

  Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)} · CPC title

• A61B2010/0208

  Biopsy devices with actuators, e.g. with triggered spring mechanisms · CPC title

• A61B2010/0225

  for taking multiple samples · CPC title

• A61B10/0275 Primary

  with sample notch, e.g. on the side of inner stylet · CPC title

• A61B2018/00577

  Ablation · CPC title