Disposable biopsy devices and methods of obtaining tissue biopsy samples using same

Abstract

The described invention provides a disposable handheld biopsy device for taking biopsies, the biopsy device comprising a tissue cutting assembly which has features to control the tissue length that will be severed by the cutting assembly; and a vacuum assembly which has features to control the vacuum level. The disposable handheld biopsy device of the described invention is simple, lightweight, portable, and cost effective to manufacture and dispose of.

What is claimed is: 
     
         1 . A disposable biopsy device comprising:
 A. a tissue cutting assembly comprising:   an outer needle including a tissue receiving slot at a distal end of the outer needle; an elongated tube; an inner cutter needle including a tissue receiving port at a distal end of the inner cutter needle; a first plunger; and a first stopper;   wherein   (i) the outer needle is attached to a distal end of the tube;   (ii) the inner cutter needle is attached to a distal end of the first plunger;   (iii) the inner cutter needle and the first plunger are coaxially positioned within the tube and capable of rotating about and translating along the longitudinal axis of the tube;   (iv) the inner cutter needle is coaxially positioned within the outer needle and capable of rotating about and translating along the longitudinal axis of the outer needle; and   (v) the first stopper is attached to or connected to a proximal end of the tube; and   B. a vacuum assembly comprising:   an elongated cylinder; a second plunger; and a second stopper;   wherein   (i) the second plunger is coaxially disposed within the cylinder and capable of rotating about and translating along the longitudinal axis of the cylinder; and   (ii) the second stopper is attached to or connected to a proximal end of the cylinder;   wherein the vacuum assembly and the cutting assembly are two separate compartments in fluid communication through one or more air holes in between.   
     
     
         2 . The disposable biopsy device according to  claim 1 , wherein the tube has one or more air path holes on a bottom surface of the tube, the cylinder has one or more air path holes on the top surface of the cylinder, and the inner cutter needle has one or more holes near its proximal end such that the vacuum generated by pulling the second plunger creates a low pressure region near the tissue receiving slot. 
     
     
         3 . The disposable biopsy device according to  claim 2 , wherein the tube has an air release hole on a top surface of the tube for releasing the vacuum. 
     
     
         4 . The disposable biopsy device according to  claim 1 , wherein the first plunger and the first stopper are configured to mate thereby controlling a length of tissue to be severed from a tissue mass; and the second plunger and the second stopper are configured to mate thereby controlling vacuum levels. 
     
     
         5 . The disposable biopsy device according to  claim 1 , wherein the tube has a cutting length indicator which has numerical indicia corresponding to the length of tissue to be separated from the tissue mass. 
     
     
         6 . The disposable biopsy device according to  claim 1 , wherein the first plunger comprises a plunger rod, one or more ridges, and one or more notches on the plunger rod, the first plunger together with the first stopper controlling the length of tissue to be severed. 
     
     
         7 . The disposable biopsy device according to  claim 1 , wherein the first plunger comprises a plunger rod, a plurality of raised edges extending laterally therefrom, and a plurality of ridges disposed at predetermined position across adjacent raised edges, and a plurality of notches in front of or behind the ridges, the first plunger together with the first stopper controlling the length of tissue to be severed. 
     
     
         8 . The disposable biopsy device according to  claim 1 , wherein the first plunger comprises a plunger rod, a plurality of raised edges extending laterally therefrom, and a plurality of ridges disposed at predetermined position across adjacent raised edges wherein the first stopper is configured to engage the ridge on the first plunger thereby stopping the plunger from moving forward and controlling the length of tissue. 
     
     
         9 . The disposable biopsy device according to  claim 8 , wherein the first plunger has a plurality of notches thereon which allow the first plunger to be rotated, which disengages the first stopper and allows the first plunger to move further backward or forward. 
     
     
         10 . The disposable biopsy device according to  claim 1 , wherein the second plunger comprises a plunger rod, and one or more ridges, and one or more notches on the plunger rod, the second plunger together with the second stopper controlling the vacuum levels. 
     
     
         11 . The disposable biopsy device according to  claim 1 , wherein the second plunger and the second stopper work together to control vacuum levels, the second plunger comprising a plunger rod, a plurality of raised edges extending laterally therefrom, and a plurality of ridges disposed at predetermined position across adjacent raised edges, which when engaged, the second stopper stops the forward or backward movement of the plunger, and a plurality of notches in front of or behind the ridges, which allow the plunger to freely rotate, so that the second stopper is disengaged and the plunger is allowed to move forward or backward. 
     
     
         12 . The disposable hand held biopsy device according to  claim 1 , wherein the second plunger comprises a plunger rod, a plurality of raised edges projecting laterally therefrom, and a plurality of notches breaking the raised edges, and the second stopper is configured to interlock the raised edge of the plunger and restrict the plunger from rotating freely, while the notches allow the plunger to rotate and disengage the second stopper. 
     
     
         13 . The disposable biopsy device according to  claim 1 , wherein the sample receiving slot has saw teeth thereon along its lateral sides, which hold the tissue tightly prior to and at the time that the inner cutter needle advances to cut the prolapsed tissue from the tissue mass. 
     
     
         14 . The disposable biopsy device according to  claim 1 , further comprising the a sample collector, which grasps the severed tissue sample out of the inner cutter needle such that the tissue sample is securely handled. 
     
     
         15 . The disposable biopsy device according to  claim 1 , further comprising a shell that closely encloses the tube and cylinder. 
     
     
         16 . The disposable biopsy device according to  claim 3 , further comprising a silicone fitting on top of the air release hole that seals the air release hole when pressed and releases the vacuum inside the biopsy device when released. 
     
     
         17 . The disposable biopsy device according to  claim 1 , wherein the distal end of the outer needle is open and sharp such that it is easy to insert into the tissue. 
     
     
         18 . The disposable hand held biopsy device according to  claim 1 , wherein the distal end of the inner cutter needle is open, beveled in shape, and contains a razor sharp edge that is effective to slice the tissue prolapsed into the tissue receiving slot and collect the severed tissue in its tissue receiving port. 
     
     
         19 . The disposable biopsy device according to  claim 1 , wherein the first and second stoppers are continued as one unit or are two separate units. 
     
     
         20 . A method of obtaining a tissue sample for biopsy examination using a disposable hand held biopsy device, the method comprising:
 (a) providing a disposable biopsy device, the device comprising:
 (1) a tissue cutting assembly comprising:
 an outer needle comprising a tissue receiving slot at a distal end of the outer needle and saw teeth along lateral sides of the tissue receiving slot; an elongated tube comprising an air release hole and a cutting length indicator on a top surface of the tube; an inner cutter needle comprising a tissue receiving port at a distal end of the inner cutter needle; a first plunger; a first stopper; a silicone fitting on top of the air release hole; and a tissue sample collector; 
 wherein 
 (i) the outer needle is attached to a distal end of the tube; 
 (ii) the inner cutter needle is attached to a distal end of the first plunger; 
 (iii) the inner cutter needle and the first plunger are coaxially positioned within the tube and capable of rotating about and translating along the longitudinal axis of the tube; 
 (iv) the inner cutter needle is coaxially positioned within the outer needle and capable of rotating about and translating along the longitudinal axis of the outer needle; and 
 (v) the first stopper is attached to or connected to a proximal end of the tube; and 
 
 (2) a vacuum assembly comprising:
 an elongated cylinder; a second plunger; and a second stopper; 
 wherein 
 (i) the second plunger is coaxially disposed within the cylinder and capable of rotating about and translating along the longitudinal axis of the cylinder; and 
 (ii) the second stopper is attached to or connected to a proximal end of the cylinder; 
 
 wherein the vacuum assembly and the cutting assembly are two separate compartments in fluid communication through one or more air holes in between; and 
   (b) placing the outer needle at a location of collecting sample tissue;   (c) covering the air release hole;   (d) withdrawing the second plunger, rotating the plunger, and locking the plunger in place;   (e) pulling the first plunger backward such that its distal end is aligned with one of the numerical indicia on the cutting length indicator corresponding to a desired tissue length, exposing the tissue receiving slot on the outer needle so that the tissue prolapses into the sample receiving slot and is held tight by the vacuum and the saw teeth along the tissue receiving slot;   (f) releasing the first plunger and the attached inner cutter needle, which are then propelled by a gradient pressure to advance into the tissue receiving slot and sever the tissue, which has prolapsed into the sample port, and stops when it hits the first stopper;   (g) allowing air flow into the biopsy device, releasing the vacuum;   (h) pulling the biopsy device out from the body; and once outside the body,
 (1) turning the first plunger clockwise until it stops; 
 (2) pushing the first plunger all the way forwards; 
 (3) grasping the outer needle near the distal end of the outer needle using the sample collector; and 
 (4) pulling the inner cutter needle backward to allow the severed tissue sample to fall out of the device by gravity. 
   
     
     
         21 . The method according to  claim 20 , wherein the tube has one or more air path holes on the bottom surface, the cylinder has one or more air path holes on the top surface and the inner cutter needle has one or more holes near its proximal end, such that the vacuum generated by pulling the second plunger creates the low pressure region near the tissue receiving slot. 
     
     
         22 . The method according to  claim 20 , wherein the first plunger and the first stopper are configured to mate thereby controlling the length of the tissue to be severed from the tissue mass; and the second plunger and the second stopper are configured to mate thereby controlling the vacuum levels. 
     
     
         23 . The method according to  claim 20 , wherein the first plunger comprises a plunger rod, one or more ridges, and one or more notches on the plunger rod, the first plunger together with the first stopper controlling the length of tissue to be severed. 
     
     
         24 . The method according to  claim 20 , wherein the first plunger comprises a plunger rod, a plurality of raised edges extending laterally therefrom, a plurality of ridges disposed at predetermined position across adjacent raised edges, and a plurality of notches in front of or behind the ridges, the first plunger together with the first stopper controlling the length of tissue to be severed. 
     
     
         25 . The method according to  claim 20 , wherein the first plunger comprises a plunger rod, a plurality of raised edges extending laterally therefrom, and a plurality of ridges disposed at predetermined position across adjacent raised edges, wherein the first stopper is configured to engage the ridge on the first plunger thereby stopping the plunger from moving forward whereby controlling the tissue length. 
     
     
         26 . The method according to  claim 25 , wherein the first plunger comprises a plurality notches thereon, which allow the first plunger to be rotated, thereby dis-engaging the first stopper and allowing the first plunger to move further backward or forward. 
     
     
         27 . The method according to  claim 20 , wherein the second plunger comprises a plunger rod, one or more ridges, and one or more notches on the plunger rod, the second plunger together with the second stopper controlling the vacuum levels. 
     
     
         28 . The method according to  claim 20 , wherein the second plunger and the second stopper work together to control the vacuum levels, the second plunger comprising a plunger rod, a plurality of raised edges extending laterally therefrom, and a plurality of ridges disposed at predetermined positions across adjacent raised edges, which when they engage the second stopper stops the forward or backward movement of the plunger, and a plurality of notches in front of or behind the ridges, which allow the plunger to freely rotate thereby disengaging the second stopper and allowing the plunger to move forward or backward. 
     
     
         29 . The method according to  claim 20 , wherein the second plunger comprises a plunger rod, and a plurality of raised edges projecting laterally therefrom, wherein the second stopper is configured to interlock the raised edge of the plunger, restricting the plunger from rotating freely, and the plunger has a plurality of notches allowing the plunger to rotate and disengage the second stopper. 
     
     
         30 . The method according to  claim 20 , wherein the disposable biopsy device further comprising a shell that closely encloses the tube and cylinder. 
     
     
         31 . The method according to  claim 20 , wherein the distal end of the outer needle is open and sharp such that it is easy to insert into the tissue. 
     
     
         32 . The method according to  claim 20 , wherein the distal end of the inner cutter needle is open, beveled in shape, and contains a razor sharp edge, the distal end of the inner cutter needle slicing the tissue prolapsed into the tissue receiving slot and collecting the severed tissue in its tissue receiving port.