Abstract:
An Advanced Biopsy Needle is disclosed that provides both fine needle aspiration and core biopsy with a single insertion, thus reducing trauma and pain to the patient. An inner needle for aspiration and an outer needle for core biopsy are in coaxial relation to each other, thus providing both histology and cytology functions with a single medical device and also with a single insertion. Lateral cutting edges along fenestration openings in the outer needle ensure that adequate tissue samples are taken. A syringe is attached to the inner needle for collection of aspirate.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates generally to medical needles, and more particularly to an Advanced Biopsy Needle. 
         [0003]    2. Description of the Related Art 
         [0004]    Biopsy needles are commonly used to retrieve tissue, fluids, or other bodily samples for testing. Fine needle aspiration, for example, is a procedure where a needle is passed through the skin into areas of concern such as cysts, nodules, internal organs or other masses. The sample of fluids and/or cells is then aspirated through the needle into a syringe or similar collection device. The sample of cells then undergoes a cytology exam or perhaps a histology exam should tissue be collected along with the aspirated cells. Another common biopsy procedure is a core needle biopsy where a larger, hollow needle is used to remove cores of tissue from the area of concern. A core biopsy at times involves multiple insertions to ensure that adequate tissue samples are collected for a histology exam. While there are other biopsy procedures, fine needle aspiration and core needle biopsy are the most common, and at times both procedures are used on a patient. 
         [0005]    What is therefore needed and beneficial is a biopsy needle that provides both fine needle aspiration and core biopsy with a single insertion, thus reducing trauma and pain to the patient. What is also needed is a biopsy needle that provides superior tissue retrieval and sampling with a single insertion. 
         [0006]    It is thus an object of the present invention to provide an Advanced Biopsy Needle. While the Advanced Biopsy Needle comprises an inner and outer needle, the term Advanced Biopsy Needle refers to both needles and the novel coaxial arrangement of the inner aspiration needle and the outer core needle. These and other objects of the present invention are not to be considered comprehensive or exhaustive, but rather, exemplary of objects that may be ascertained after reading this specification with the accompanying drawings and claims. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    In accordance with the present invention, there is provided an Advanced Biopsy Needle comprising an outer needle comprising a hollow metal wire having a shaft, a sharp end, a fastening end and a cutting slot, the cutting slot comprising at least one fenestration opening having lateral walls wherein at least one lateral wall has a sharp cutting surface; an outer needle hub affixed to the fastening end of the outer needle; an inner needle comprising a hollow metal wire having a shaft, a sharp end and a fastening end; and an inner needle hub affixed to the fastening end of the inner needle; wherein the outer needle and the inner needle are arranged coaxial with each other such that the outer needle and the inner needle penetrate tissue together and wherein the inner needle can be removed from the outer needle once aspiration is performed. 
         [0008]    The foregoing paragraph has been provided by way of introduction, and is not intended to limit the scope of the invention as described by this specification and the attached drawings and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The invention will be described by reference to the following drawings, in which like numerals refer to like elements, and in which: 
           [0010]      FIG. 1  depicts a perspective view of the Advanced Biopsy Needle; 
           [0011]      FIG. 2  is an exploded view of the Advanced Biopsy Needle of  FIG. 1 ; 
           [0012]      FIG. 3  is a plan view of the Advanced Biopsy Needle; 
           [0013]      FIG. 4  is a cross sectional view of the Advanced Biopsy Needle taken along line A-A of  FIG. 3 ; 
           [0014]      FIG. 5  is a plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 1 ; 
           [0015]      FIG. 6  is a close up cross sectional view of the outer needle of  FIG. 5  taken along line B-B of  FIG. 5 ; 
           [0016]      FIG. 7  is a plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 1 ; 
           [0017]      FIG. 8A  is a cross sectional view of the outer needle taken along line C-C of  FIG. 7 ; 
           [0018]      FIG. 8B  is a cross sectional view of the outer needle taken along line C′-C′ of  FIG. 7 ; 
           [0019]      FIG. 9  is a perspective view of the Advanced Biopsy Needle without an attached syringe; 
           [0020]      FIG. 10  is a rotated plan view of the Advanced Biopsy Needle; 
           [0021]      FIG. 11  is a plan view of the Advanced Biopsy Needle with an attached syringe; 
           [0022]      FIG. 12  is a rotated plan view of the Advanced Biopsy Needle with an attached syringe; 
           [0023]      FIG. 13  is a further rotated plan view of the Advanced Biopsy Needle with an attached syringe; 
           [0024]      FIG. 14  is a cross sectional view of the Advanced Biopsy Needle taken along line D-D of  FIG. 11 ; 
           [0025]      FIG. 15  is a plan view of a second embodiment of the outer needle of the Advanced Biopsy Needle; 
           [0026]      FIG. 16  is a cross sectional view of the outer needle of the Advanced Biopsy Needle taken along line E-E of  FIG. 15 . 
           [0027]      FIG. 17  is a close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 ; 
           [0028]      FIG. 18  is a rotated close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 ; 
           [0029]      FIG. 19  is a further rotated close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 : 
           [0030]      FIG. 20  is a perspective view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 ; 
           [0031]      FIG. 21  is a rotated perspective view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 ; and 
           [0032]      FIGS. 22-26  depict the Advanced Biopsy Needle in use for fine aspiration and core biopsy. 
       
    
    
       [0033]    The present invention will be described in connection with a preferred embodiment, however, it will be understood that there is no intent to limit the invention to the embodiment described. On the contrary, the intent is to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by this specification, drawings and claims provided herein. 
       DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0034]    The Advanced Biopsy Needle of the present invention may have various embodiments, some of which are described herein, and others of which may be inferred from or otherwise envisioned based on the disclosure contained herein. 
         [0035]    Medical needles, including those of the present invention, are generally constructed from a hollow metal wire where a shaft is formed with a sharp end and a fastening end for placement of a fastening device that is then removably connected to a syringe or the like. Stainless steel is a commonly used material for medical needles. To manufacture a medical needle, the hollow metal wire, or cannula, is formed from a larger metal tube which is fabricated by rolling a sheet of metal into a tube and then welding the resulting seam. Laser welding is commonly used to join the tube together. Another technique to create a medical needle is where a solid piece of metal may be bored and machined, however such an approach is significantly more costly than welding a formed tube. Once the rolled and welded metal tube is created, it is heated and drawn through a series of progressively smaller dies to stretch the length of the tube while at the same time decrease the diameter of the tube until the final draw is performed typically without heat. Cold working of the tube increases the strength and hardness of the tube. At times a mandrel of similar form is placed inside the tube to prevent tube wall collapse, but usually the tolerances provided by the equipment and related manufacturing processes are such that a mandrel or form is not necessary. Once a hollow metal wire is created, it is cut to a specified length and a sharp end is created on a first end of the cut hollow metal wire by grinding, cutting a bevel, or the like. For the Advanced Biopsy Needle of the present invention, the outer needle then receives a secondary operation where cutting slots are formed in the wall of the needle by grinding, cutting, or the like. Lastly, with medical needles, a Luer fastener such as a LUER-LOCK® or a LUER-SLIP® connector is placed on the fastening end of the hollow metal wire by press fitting, friction fitting, adhesion, or the like. LUER-LOCK® and LUER-SLIP® are registered trademarks of Becton Dickinson and Company of Franklin Lakes, N.J. 
         [0036]    The present invention and the various embodiments described and envisioned herein will be further described herein, with the drawings forming an essential part of the disclosure. The drawings were created using 3D modeling software, and portray exemplary, but not limiting, embodiments of the present invention. 
         [0037]    The Advanced Biopsy Needle of the present invention allows for the extraction of both cells as well as tissue through a novel slotted sleeve and retractable core arrangement. The hollow slotted sleeve of the biopsy needle has at least one fenestration opening such as a slot in the sleeve, as well as a sharpened tip for insertion. The lateral walls of the slot are blade-sharp to facilitate cutting and sampling of tissue. The hollow slotted sleeve or outer needle is coaxial with a retractable core or inner needle, and both inserted in the anatomical area to be sampled. The hollow slotted sleeve or outer needle has a handle to facilitate rotation of the outer needle once inserted. A retractable core inner needle, also hollow and with a sharpened tip, is inserted within the sleeve or outer needle to prevent passageway tissue(s) from collapsing into the hollow slotted sleeve or outer needle. Once the desired target tissue is reached, the inner needle retractable core is used to aspirate cells for cytology examination and/or fluids. The inner needle retractable core is then withdrawn, while the hollow slotted sleeve outer needle is left in place for the desired tissue sample retrieval. Tissue sample is then obtained by rotation of the hollow slotted sleeve outer needle. Upon removal of the hollow slotted sleeve outer needle, the tissue sample is captured and can be extracted for subsequent testing and analysis. 
         [0038]    Two exemplary embodiments of the Advanced Biopsy Needle are depicted by way of example and depicted with the attached figures. Both embodiments have two cutting slots with differing placement along the axis of the outer needle. In some embodiments of the present invention, one cutting slot or more than two cutting slots are employed. In describing the present invention and the various embodiments described and envisioned herein, the term axis is used. The axis of each needle is parallel with the length of the needle, in other words the axis follows the open inner passageway of the needle. 
         [0039]    Turning now to the various figures provided,  FIG. 1  depicts a perspective view of the Advanced Biopsy Needle  100 . The inner needle and outer needle are assembled in coaxial relation to each other, and the inner needle cannot be seen in  FIG. 1 . The outer needle  109  can be seen with a first cutting slot  111  and a second cutting slot  113 . Each of these fenestration openings will be depicted in further detail in subsequent figures. The outer needle  109  has a shaft  119  with a sharp end or outer needle tip  115  and a fastening end  117 . The sharp end or outer needle tip  115  may be provided with a bevel or similar sharpened feature for ease of insertion into bodily tissue. The fastening end  117  receives an outer needle hub  105  that may include, in some embodiments of the present invention, a Luer fastener or the like. The outer needle hub may also include, in some embodiments of the present invention, a grip  107  such as a pair of outwardly extending wings, a lever, a knurled surface, a textured surface, a cylindrical surface, a rectangular extension, a triangular extension, a curved or non-linear surface, or the like. The outer needle hub  105  and related grip  107  may be made from a plastic such as nylon, polypropylene, or the like, and may be made by injection molding, blow molding, printing, machining, or the like. Fastened to the outer needle  109  by way of the outer needle hub  105  and related fastener is a syringe  101  that comprises a barrel (body of the syringe as indicated by  101 ) and a plunger  103 . The syringe may be made from a plastic such as, for example, polypropylene, nylon, and may be made by injection molding, blow molding, printing, machining, or the like, or may be made from other material such as glass, metal, or the like. The plunger  103  may include a sealing tip made from silicone, a rubber, or the like, in order to push or pull fluid in or out of the syringe barrel. The plunger  103  and barrel  101  (syringe) may also be made from a plastic such as, for example, polypropylene, nylon, and may be made by injection molding, blow molding, printing, machining, or the like, or may be made from other material such as glass, metal, or the like. Also shown in  FIG. 1 , and depicted in more detail in  FIG. 2 , is an inner needle hub  205  that is fastened to a fastening end of the inner needle (not shown in  FIG. 1 , see  FIG. 2 ). The inner needle hub  205  may be made from a plastic such as polypropylene or nylon, and may be made by injection molding, blow molding, printing, machining, or the like. 
         [0040]      FIG. 2  is an exploded view of the Advanced Biopsy Needle of  FIG. 1 . The inner needle  201  can be clearly seen with an inner needle tip or sharp end  203 , a shaft  209 , a fastening end  211  with an inner needle hub  205  attached thereto. A syringe hub  207  can also be seen for removable coupling of the inner needle  201  to the syringe  101 . The inner needle hub  205  may be made from a plastic such as, for example, polypropylene, nylon, and may be made by injection molding, blow molding, printing, machining, or the like, or may be made from other material such as metal, or the like. The inner needle hub  205  may also include a fastener such as a Luer fastener or the like. The inner needle hub  205  removably attaches to the syringe hub  207 . Further, in some embodiments of the present invention, the inner needle hub  205  fits at least partially within the outer needle hub  105  or further mates together. In some embodiments of the present invention, the inner needle hub  205  and the outer needle hub  105  contain mating surfaces such that each hub receives and couples with the other. Such mating surfaces may contain ridges, valleys, locking features, or the like. In one embodiment of the present invention, the inner needle tip  203  and the outer needle tip  115  are in alignment with each other when initially installed in coaxial relation one to the other. In some embodiments of the present invention, guides, tabs, slots, or other features may be employed to ensure that the inner needle tip  203  and the outer needle tip  115  stay in alignment with each other. 
         [0041]      FIG. 3  is a plan view of the Advanced Biopsy Needle showing the outer needle  109  and an exemplary needle hub  105  that has been fitted with a grip  107 .  FIG. 4  is a cross sectional view of the Advanced Biopsy Needle taken along line A-A of  FIG. 3  so that the first cutting slot  111  and the second cutting slot  113  are clearly depicted. The first and second cutting slots are depicted as rectangular fenestration openings; however, other geometries such as square openings, oval openings, circular openings, and the like may also be employed. In addition, variation of needle size, fenestration to tip spacing, slot to slot spacing, direction of slots, percent of total circumference of the needle removed or remaining for each slot, and other dimensional attributes are to be considered within the scope and content of the present invention. Such changes may be made for a variety of reasons, including but not limited to, the tissue to be biopsied.  FIG. 5  is a plan view of the outer needle  109  of the Advanced Biopsy Needle of  FIG. 1  without an outer needle hub attached. To more clearly see an example of a first cutting slot  111  and a second cutting slot  113 ,  FIG. 6  is a close up cross sectional view of the outer needle of  FIG. 5  taken along line B-B of  FIG. 5 . Each fenestration opening has two lateral walls where at least one lateral wall has a sharp cutting surface. The lateral walls are essentially the perimeter or edge of the fenestration opening that is generally parallel to the axis of the outer needle  109 . To create a sharp cutting surface along a lateral wall, a bevel or taper is created by grinding, machining, cutting or the like.  FIG. 7  is a plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 1  that depicts one embodiment of the fenestration openings. For a better understanding of the sharp cutting surface of each cutting slot,  FIG. 8  is a cross sectional view of the outer needle taken along line C-C of  FIG. 7 . Since a portion of the perimeter of the outer needle wall has been removed in order to create each fenestration opening, a lateral section  801  has been created where the wall of the outer needle does not span the entire perimeter of the outer needle, as seen in  FIG. 8 . This lateral section  801  in turn has two lateral walls, each of which in one embodiment have been sharpened to create a first cutting edge lateral wall  803  and a second cutting edge lateral wall  805 . In one embodiment of the present invention, the cutting edge of each lateral wall is tapered inwardly. 
         [0042]      FIG. 9  is a perspective view of the Advanced Biopsy Needle without an attached syringe and with only the outer needle  109  visible. 
         [0043]      FIG. 10  is a rotated plan view of the Advanced Biopsy Needle showing the first cutting slot  111  and the second cutting slot  113 . It should be noted that the placement of the cutting slots, and the quantity thereof, may vary. A change in placement of each cutting slot along the axis of the outer needle provides for tissue sampling at varying depths of penetration, which may prove useful for various procedures. 
         [0044]      FIG. 11  is a plan view of the Advanced Biopsy Needle with an attached syringe showing an exemplary embodiment of the visible outer needle  109 . The inner needle cannot be seen.  FIG. 12  is a rotated plan view of the Advanced Biopsy Needle with an attached syringe.  FIG. 13  is a further rotated plan view of the Advanced Biopsy Needle with an attached syringe.  FIG. 14  is a cross sectional view of the Advanced Biopsy Needle taken along line D-D of  FIG. 11 . In  FIG. 14 , the inner workings of the syringe  101  can be seen including the plunger  103  and sealing end that traverses the interior of the syringe barrel in order to maintain a seal and associated pressure or suction thereof. 
         [0045]    As previously stated, the cutting slot fenestrations may vary in shape, position, and quantity.  FIGS. 15-21  provide a second example of an embodiment of the outer needle. In the example provided by  FIGS. 15-21 , there are two fenestration openings opposing each other along the axis of the outer needle.  FIG. 15  depicts a plan view of this second embodiment of the outer needle of the Advanced Biopsy Needle showing the second embodiment of the outer needle  1501 . The outer needle comprises a first cutting slot  1503  and a second cutting slot  1505  where the two fenestration openings of each cutting slot oppose each other along the axis of the outer needle. The outer needle tip  1507  is also depicted in this example as a bevel. This will become clear upon reviewing  FIGS. 16 and 17  where  FIG. 16  is a cross sectional view of the outer needle of the Advanced Biopsy Needle taken along line E-E of  FIG. 15 . A first lateral section  1601  and a second lateral section  1607  can be seen in cross section where a first cutting edge  1603  and a second cutting edge  1605  are formed at the edge or along a contour or geometry of the first lateral section  1601 . In a similar manner, a third cutting edge  1609  and a fourth cutting edge  1605  are formed at the edge or along a contour or geometry of the second lateral section  1607 . These lateral sections each have two lateral walls, each of which in one embodiment have been sharpened to create the corresponding cutting edges referred to above. In one embodiment of the present invention, the cutting edge of each lateral wall is tapered inwardly. 
         [0046]      FIG. 17  is a close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15  which clearly shows the second cutting slot  1505  with the first cutting slot  1503  in opposing spatial relation to the second cutting slot  1505 . 
         [0047]      FIG. 18  is a rotated close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 .  FIG. 19  is a further rotated close-up plan view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 .  FIG. 20  is a perspective view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 .  FIG. 21  is a rotated perspective view of the outer needle of the Advanced Biopsy Needle of  FIG. 15 . In one embodiment of the present invention, the angle of the outer needle tip is in alignment with an opening in a cutting slot. In other words, when viewed from the side of the outer needle (a plan view) where the bevel of the outer needle tip is oriented such that the interior of the needle can be seen, the cutting slots will also be oriented such that there is maximum visibility through the needle from one side to the other. This alignment and orientation can be clearly seen by way of  FIG. 21 . 
         [0048]    Lastly,  FIGS. 22-26  sequentially depict the Advanced Biopsy Needle in use for fine aspiration and core biopsy.  FIG. 22  depicts the Advanced Biopsy Needle being inserted into tissue  2203  in the direction of travel indicated by the accompanying arrow. The outer needle  2201  (any of the embodiments described or envisioned herein) can be seen being inserted in the tissue  2203  along with a (not visible) inner needle such as the inner needle  201  of  FIG. 2 . In  FIG. 23  the plunger  103  of the syringe  101  is withdrawn to draw (aspirate) fluid and perhaps tissue into the barrel of the syringe by way of the inner needle  201  (see  FIG. 2 ) that is connected to the syringe  101  by way of inner needle hub  205 . The plunger  103  is withdrawn in accordance with the arrow that accompanies  FIG. 22 . In  FIG. 24 , the aspirated sample has been collected and the syringe  101  and attached inner needle  201  are withdrawn from the outer needle  2201 , leaving the outer needle  2201  remaining in the tissue. The obtained sample can then be sent for appropriate analytical tests.  FIG. 25  then depicts a series of illustrations where the outer needle  2201  is rotated using the grip  107  while remaining in the tissue  2203  such that a core sample of tissue is obtained by way of the inserted and embedded cutting slots of the outer needle  2201 . Once the rotation is completed, the outer needle  2201  is withdrawn from the tissue  2203  as depicted by way of  FIG. 26  and the associated directional arrow. The outer needle  2201  is then placed in a suitable sample receiving device where it can be sent for appropriate analytical tests. 
         [0049]    It is, therefore, apparent that there has been provided, in accordance with the various objects of the present invention, an Advanced Biopsy Needle. 
         [0050]    While the various objects of this invention have been described in conjunction with preferred embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of this specification, drawings, and claims provided herein.