US2019239864A1PendingUtilityA1

System, method and apparatus for integrated tissue sampling and tissue marker placement

Assignee: DEVICE AND DESIGN LLCPriority: Feb 6, 2017Filed: Apr 17, 2019Published: Aug 8, 2019
Est. expiryFeb 6, 2037(~10.5 yrs left)· nominal 20-yr term from priority
Inventors:Shree K. Subedi
A61B 2090/3987A61B 2090/3908A61B 10/0275A61B 90/39A61B 10/0233A61B 10/0283
32
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Claims

Abstract

A medical device can include an actuator that is gripped and manipulated by an operator of the medical device. An outer cannula can extend from the actuator along an axis. The outer cannula can include a tissue reception port. An inner cannula can be located inside the outer cannula and extend in an axial direction. An inner lumen can be located inside the inner cannula and actuated to collect a tissue sample via the tissue reception port. In addition, a secondary lumen can be adjacent to the outer cannula and actuated to deploy a marker at a biopsy site via a marker deployment port. Tissue sampling and marker placement functions can be integrated within only one medical device such that the medical device is a single apparatus that performs both tissue sampling and marker placement functions.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . An integrated, dual function medical apparatus configured to enable the collection of a tissue sample from a biopsy site of a patient and placement of a tissue marker at the biopsy site via a single insertion of the medical apparatus, the medical apparatus comprising:
 a tissue collection system including
 an outer cannula defining a sharp distal tip, a proximal actuator and an outer cannula wall defining a primary lumen extending therebetween, the outer cannula wall further defining a tissue receiving port in fluid communication with the primary lumen; and 
 an inner cannula axially shiftable relative to the outer cannula between a first position enabling the tissue sample from the biopsy site of the patient to enter the primary lumen of the outer cannula through the tissue receiving port, and a second position enabling isolation of the tissue sample from the biopsy site for collection purposes; and 
   a marker deployment device including structure defining a secondary lumen configured to house at least one tissue marker for selective deployment at the biopsy site, the secondary lumen separated from the primary lumen by an inner panel configured to separate the secondary lumen from the primary lumen, thereby enabling operation of the tissue collection system independent from the marker deployment device.   
     
     
         22 . The medical apparatus of  claim 21 , wherein the inner panel between the primary lumen from the secondary lumen is configured to isolate and inhibit a fluid connection between the primary lumen and the secondary lumen. 
     
     
         23 . The medical apparatus of  claim 21 , wherein the primary lumen and the secondary lumen are defined by the outer cannula, wherein the portion of the outer cannula between the primary lumen and the secondary lumen comprises the inner panel. 
     
     
         24 . The medical apparatus of  claim 21 , wherein the structure defining the secondary lumen of the marker deployment device further defines a marker deployment aperture positioned along a lateral side of the medical apparatus opposite to the tissue receiving port. 
     
     
         25 . The medical apparatus of  claim 24 , wherein the marker deployment aperture is positioned along an axial length of the medical apparatus at an approximate mid-line of the tissue receiving port. 
     
     
         26 . The medical apparatus of  claim 21 , wherein the outer cannula has a variable cross section along its axial length. 
     
     
         27 . The medical apparatus of  claim 21 , wherein at least a portion of the outer cannula has a generally non-circular cross sectional shape configured to vertically align with an incision made in the patient. 
     
     
         28 . The medical apparatus of  claim 21 , wherein the primary lumen and the inner cannula have a complimentary non-circular cross sectional shape to inhibit rotation of the inner cannula relative to the primary lumen. 
     
     
         29 . (canceled) 
     
     
         30 . The medical apparatus of  claim 21 , wherein the secondary lumen of the marker deployment device is configured to house a train of tissue markers. 
     
     
         31 . The medical apparatus of  claim 21 , wherein the marker deployment device further includes a plunger positioned in the secondary lumen, configured to act as a deployment mechanism for the at least one tissue marker. 
     
     
         32 . The medical apparatus of  claim 21 , further comprising a sheath configured to at least partially surround the outer cannula. 
     
     
         33 . The medical apparatus of  claim 32 , wherein the sheath is configured to contain the marker deployment device. 
     
     
         34 . An integrated, dual function medical apparatus configured to enable the collection of a tissue sample and placement of a tissue marker at a biopsy site via a single insertion of the medical apparatus, the medical apparatus comprising:
 a tissue collection system including
 a stationary inner cannula defining a sharp distal tip, a proximal actuator and structure defining a tissue receiving port; and 
 an outer cannula axially shiftable relative to the stationary inner cannula between a first position enabling the tissue sample from the biopsy site of the patient to enter the tissue receiving port of the stationary inner cannula, and a second position enabling isolation of the tissue sample from the biopsy site for collection purposes; and 
   a marker deployment device including structure defining a secondary lumen configured to house at least one tissue marker for selective deployment at the biopsy site, the secondary lumen separated from the primary lumen by an inner panel configured to independently seal and separate the secondary lumen from the primary lumen, thereby enabling operation of the tissue collection system independent from the marker deployment device.   
     
     
         35 . The medical apparatus of  claim 34 , wherein the primary lumen and the secondary lumen are defined by the outer cannula, wherein the portion of the outer cannula between the primary lumen and the secondary lumen comprises the inner panel. 
     
     
         36 . The medical apparatus of  claim 34 , wherein the outer cannula has a variable cross section along its axial length. 
     
     
         37 . The medical apparatus of  claim 34 , wherein at least a portion of the outer cannula has a generally non-circular cross sectional shape configured to vertically align with an incision made in the patient. 
     
     
         38 . The medical apparatus of  claim 34 , wherein the primary lumen and the inner cannula have a complimentary non-circular cross sectional shape to inhibit rotation of the inner cannula relative to the primary lumen. 
     
     
         39 . (canceled) 
     
     
         40 . A method of collecting a tissue sample from a biopsy site of a patient and placement of a tissue marker at the biopsy site, the method comprising:
 inserting a sharp distal tip of an outer cannula into a patient to position a tissue receiving port defined by the outer cannula in proximity to a biopsy site of a patient;   axially shifting an inner cannula relative to the outer cannula between a first position enabling the tissue sample from the biopsy site of the patient to enter a primary lumen of the outer cannula through the tissue receiving port, and a second position enabling isolation of the tissue sample from the biopsy site for collection purposes; and   deploying at least one tissue marker at the biopsy site from a secondary lumen, wherein the secondary lumen is separated from the primary lumen by an inner panel configured to independently seal and separate the secondary lumen from the primary lumen.   
     
     
         41 . The medical apparatus of  claim 32 , wherein the sheath contains a main lumen of the sheath and a secondary lumen, wherein the portion of the sheath between the main lumen of the sheath and secondary lumen comprises the inner panel, and wherein the outer cannula is situated within the main lumen of the sheath. 
     
     
         42 . The medical apparatus of  claim 34 , further comprising a sheath positioned external to the outer cannula and configured to contain the marker deployment device. 
     
     
         43 . The medical apparatus of  claim 42 , wherein the sheath contains a main lumen of the sheath and a secondary lumen, wherein the portion of the sheath between the main lumen of the sheath and secondary lumen comprises the inner panel, and wherein the outer cannula is situated within the main lumen of the sheath. 
     
     
         44 . A method of collecting a tissue sample from a biopsy site of a patient and placement of a tissue marker at the biopsy site, the method comprising:
 inserting a sharp distal tip of an inner cannula into a patient to position a tissue receiving port defined by the inner cannula in proximity to a biopsy site of a patient;   axially shifting an outer cannula relative to the inner cannula between a first position enabling the tissue sample from the biopsy site of the patient to enter the tissue receiving port of the inner cannula, and a second position enabling isolation of the tissue sample from the biopsy site for collection purposes; and   deploying at least one tissue marker at the biopsy site from a secondary lumen, wherein the secondary lumen is separated from the primary lumen by an inner panel configured to independently seal and separate the secondary lumen from the primary lumen.

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