Abstract:
A lumpectomy knife set including a main knife having at least one first planar wall extending between an upper edge and a knife edge with the at least one first planar wall defining a first geometric shape about a first through opening. A margin knife has at least one second planar wall extending between an upper edge and a knife edge with the at least one second planar wall defining a second geometric shape about a second through opening larger than the first through opening. The second geometric shape complements the first geometric shape such that the margin knife is concentrically positionable about the main knife with a margin gap between the main knife and the margin knife.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/275,308, filed Jan. 6, 2016, which is incorporated by reference in its entirety herein. 
     
    
     TECHNICAL FIELD 
       [0002]    This present disclosure relates to a lumpectomy cutting device, and more particularly, to a multi-dimension, two-unit knife set for lumpectomy procedures and similar procedures. 
       BACKGROUND 
       [0003]    Lumpectomy is a surgical procedure that involves removing a suspected malignant (cancerous) tumor, or lump, and a small portion of the surrounding tissue from a woman&#39;s breast. The surgeon&#39;s goal during surgery is to take out all of the cancer along with a rim of normal tissue around it. During or after surgery, a pathologist examines this rim of tissue—called the surgical margin or margin of resection—to be sure it is clear of any cancer cells. If cancer cells are present, this will influence decisions about treatments such as additional surgery and radiation. 
         [0004]    Typically, the surgeon utilizes a scalpel to cut around the target tissue and the rim of normal tissue. Conventional scalpels require multiple slicing strokes, which approaches carving that can leave rough or jagged edges. While some current scalpels slice nicely, they still leave ‘train tracks’ (the narrow incisions), which make margin assessment inaccurate, and unnecessarily leave undesired cuts. Moreover, current techniques using multiple splicing movements around all sides of the tumor using available scalpels create a challenge for properly orienting the excised specimen, thus causing inaccurate margin assessment. 
       SUMMARY 
       [0005]    In at least one embodiment, the present disclosure provides a lumpectomy knife set including a main knife having at least one first planar wall extending between an upper edge and a knife edge with the at least one first planar wall defining a first geometric shape about a first through opening. A margin knife has at least one second planar wall extending between an upper edge and a knife edge with the at least one second planar wall defining a second geometric shape about a second through opening larger than the first through opening. The second geometric shape complements the first geometric shape such that the margin knife is concentrically positionable about the main knife with a margin gap between the main knife and the margin knife. 
         [0006]    In at least one embodiment, the first and geometric shapes are each selected from one of square, rectangular, oval and circular. 
         [0007]    In at least one embodiment, the main knife and the margin knife include index markings to facilitate concentric alignment therebetween. 
         [0008]    In at least one embodiment, the main knife and the margin knife are interconnected to one another by connectors extending within the margin gap. 
         [0009]    In at least one embodiment, the main knife and the margin knife are interconnected to one another by a handle assembly. 
         [0010]    In at least one embodiment, the handle assembly includes a handle member extending between a pair of connection platforms such that each of the connection platforms includes a plurality of clips extending therefrom with spaces therebetween to receive the upper edges of the main knife and the margin knife. 
         [0011]    In at least one embodiment, the at least one first planar wall of the main knife has a convex knife edge and the at least one second planar wall of the margin knife has a convex knife edge. 
         [0012]    In at least one embodiment, the knife edges are interchangeable. 
         [0013]    In at least one embodiment, the main knife includes a main body having a geometric shape defined by a plurality of walls configured to extend between an upper edge and a lower connector edge such that the lower connector edge is configured for connection to a blade assembly. 
         [0014]    In at least one embodiment, the blade assembly includes a plurality of walls which complement the shape of the main body with each wall having a connector edge and a knife edge such that the connector edge of each wall is configured to removably connect with the connector edge of the main body through a snap-fit connection. 
         [0015]    In at least one embodiment, the blade assembly includes a plurality of walls which complement the shape of the main body with each wall having a connector edge in which two of the walls have a convex knife edge and the other walls have a linear knife edge such that the connector edge of each wall is configured to removably connect with the connector edge of the main body through a snap-fit connection. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the disclosure, and, together with the general description given above and the detailed description given below, serve to explain the features of the disclosure. In the drawings: 
           [0017]      FIG. 1  is an exploded perspective view of a knife set in accordance with an embodiment of the present disclosure. 
           [0018]      FIG. 2  is a top view of the assembled knife set of  FIG. 1 . 
           [0019]      FIG. 3  is a top view of a knife set in accordance with another embodiment of the present disclosure. 
           [0020]      FIG. 4  is a top view of a knife set in accordance with another embodiment of the present disclosure. 
           [0021]      FIG. 5  is a perspective view of the main knife of the knife set of  FIG. 4 . 
           [0022]      FIG. 6  is a cross-sectional view along the line  6 - 6  in  FIG. 1 . 
           [0023]      FIG. 7  is a perspective view of a main knife of another embodiment of the present disclosure. 
           [0024]      FIG. 8  is a perspective view of a main knife of yet another embodiment of the present disclosure. 
           [0025]      FIG. 9  is an exploded perspective view of a main knife of yet another embodiment of the present disclosure with an interchangeable knife edge. 
           [0026]      FIG. 10  is an exploded perspective view of the main knife of  FIG. 9  with a different interchangeable knife edge. 
           [0027]      FIG. 11  is an exploded front elevation view of the knife set of  FIG. 1  with an optional handle member. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    In consideration of the figures, it is to be understood for purposes of clarity that certain details of construction and/or operation are not provided in view of such details being conventional and well within the skill of the art upon disclosure of the document described herein. In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation of the present disclosure. The following describes preferred embodiments of the present disclosure. However, it should be understood that the present disclosure is not limited by the preferred embodiments described herein. 
         [0029]    As used in this document, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. As used herein, the term “comprising” means “including, but not limited to.” 
         [0030]    Referring to  FIGS. 1, 2 and 6 , a lumpectomy knife set  10  in accordance with an embodiment of the present disclosure will be described. While the knife set  10  is described herein with respect to a lumpectomy of breast tissue, it may be designed and utilized for other procedures on tissue having similar texture, density, and physical characteristics for which the push excision may be favored. 
         [0031]    The knife set  10  includes a main knife  20  and a margin knife  30 . In the present embodiment, the main knife  20  has four walls  21 ,  22 ,  23 ,  24  interconnected in a square configuration with a through opening  27 . Each wall  21 - 24  is preferably planar and extends between a knife edge  25  and an upper edge  26 . As illustrated in  FIG. 6 , in the present embodiment, the knife edge  25  has a symmetrically tapered, flat smooth configuration. The knife edge  25  may have other configurations, for example, serrated, asymmetrical, compound, chisel, convex or the like. In the illustrated embodiment, the upper edge  26  of each wall  21 - 24  includes a plurality of holes  28 , hooks or the like, which are configured to receive and grasp sutures attached to the tissue. Such suture-grasp allows tissue elevation on the inner excised tissue, raising resection area to provide smoother cut. The number and position of holes  28  may be varied from that illustrated and may vary between the different walls  21 - 24 . 
         [0032]    The margin knife  30  has a configuration which complements that of the main knife  20 . Accordingly, in the present embodiment, the margin knife  30  has four walls  31 ,  32 ,  33 ,  34  interconnected in a square configuration with a through opening  37  larger than an outer dimension of the main knife  20 . Each wall  31 - 34  is preferably planar and extends between a knife edge  35  and an upper edge  36 . As with the main knife  20 , the knife edge  35  may have various configurations and may be the same or different than the configuration of the main knife edge  25 , i.e. symmetrically tapered, flat smooth configuration. The knife edge  35  may have other configurations, for example, serrated, asymmetrical, compound, chisel, convex or the like. 
         [0033]    Referring to  FIG. 2 , the margin knife  30  is positioned concentrically about the main knife  20  such that a margin gap  40  is defined therebetween. In the illustrated embodiment, each wall  31 - 34  of the margin knife  30  has an indexing mark  38  which aligns with a center hole  28  of a respective main knife wall  21 - 24  to facilitate concentric alignment of the margin knife  30  about the main knife  20 . The main knife  20  may have different indexing marks than the holes  28 . It is also contemplated that the main knife  20  and the margin knife  30  may be interconnected to one another such that the concentric alignment is fixed. For example,  FIG. 3  illustrates an alternative embodiment of the knife set  10 ′ wherein connectors  42  extend between the main knife  20  and the margin knife  30 , for example, in each corner, to fix the relationship between the knifes  20 ,  30 . With this embodiment, the margin gap  40  is fixed. 
         [0034]    Referring again to  FIG. 2 , the size of main knife  20  is selected such that the through opening  27  corresponds to the desired tumor excision size and the size of the margin knife  30  is selected such that the through opening  37  provides the desired margin gap  40  to achieve the desired thickness of resection marginal tissue. A knife set  10  may include multiple main knifes  20  and multiple margin knifes  30 ,  30 ′ to achieve the desired excision. Additionally, having multiple margin knifes  30 ,  30 ′, the thickness of the margin gap  40 , and thereby the resection marginal tissue, may be increased by simply selecting a larger margin knife  30 ′. The walls  31 ′- 34 ′ again have indexing marks  38 ′ to facilitate alignment of the margin knife  30 ′ with the main knife  20 . 
         [0035]    Once the main knife  20  has been positioned relative to the target tissue and the margin knife  30  positioned and aligned concentrically thereabout, the main knife  20  and the margin knife  30  are simultaneously pushed into the tissue with a single push action. The outer margin knife  30  may include an optional depth scale  39  which allows the surgeon to precisely push the knives  20 ,  30  to a desired depth. After the knives  20 ,  30  have been pushed to the desired depth, standard excision (lumpectomy) is carried out. 
         [0036]    To facilitate simultaneous pushing, an optional handle assembly  100 , as illustrated in  FIG. 11 , may be connected to the main knife  20  and the margin knife  30 . In the illustrated embodiment, the handle assembly  100  includes a handle member  102  extending between a pair of connection platforms  104 . Each of the connection platforms  104  includes a plurality of clips  106  extending therefrom with spaces  107  therebetween to receive the upper edges  26 ,  36  of the main knife  20  and margin knife  30 . With the upper edges  26 ,  36  received in the spaces  107 , the main knife  20  and the margin knife  30  are maintained in proper alignment and may be pushed simultaneously by pushing on the handle member  102 . Other assemblies may alternatively be utilized to facilitate simultaneous pushing of the knives  20 ,  30 . 
         [0037]    The described push action of the knives  20 ,  30  is believed to provide a more precise, less-jagged, smoother excision of tumors and precise definition of the surrounding resection marginal tissue. It should be especially useful in obtaining precise, clean, non-jagged “shaves” (thin slices of tissue removed from the edge of the margin) and better margin pathological classification (R0, R1, or R2) for verification of removal of all malignant tissue in even very slim margins, which is the current trend. The clean shaves may also provide better stained tissue analysis versus rough or jagged stains. Additionally, the precise alignment between the linear knives  20 ,  30  allows for precise re-positioning, for example, if it is determined after the knives have been removed that a deeper excision is desired. Furthermore, the three-dimensional shape and minimal splicing movements minimize the challenge of properly orienting the excised specimen caused by the multiple splicing movements around all sides of the tumor using prior scalpels. 
         [0038]    While the described knives  20 ,  30  have a square configuration, the present disclosure is not limited to such. Referring to  FIGS. 4 and 5 , a knife set  10 ″ having an oval configuration is illustrated. The main knife  20 ″ has a single wall  21 ″ having an oval configuration extending about an oval through opening  27 ″. As in the previous embodiment, the wall  21 ″ is preferably planar and extends between a knife edge  25  and an upper edge  26  and may include holes  28  along the upper edge  26 . The margin knife  30 ″ has a complementary configuration with a single wall  31 ″ having an oval configuration extending about an oval through opening  37 ″. As in the previous embodiment, the wall  31 ″ is preferably planar and extends between a knife edge  35  and an upper edge  36  and has indexing marks  38  along the upper edge  36 . The knives  20 ″,  30 ″ are again positioned concentrically to one another to define a margin gap  40 . The knife set  10 ″ operates in the same manner as described above. The knives  20 ,  30  may have any other desired configuration, for example, rectangular, circular or other possibilities. 
         [0039]    Referring to  FIGS. 7 and 8 , main knives  20 ′″,  20   iv  in accordance with further embodiments of the present disclosure will be described. The main knife  20 ′″ in  FIG. 7  is substantially the same as the main knife illustrated in  FIG. 1  except that the front and rear walls  21 ′″,  23 ′″ have convex knife edges  25 ′″. The side walls  22 ,  24  have linear knife edges  25  as in the previous embodiment. The main knife  20   iv  in  FIG. 8  is substantially the same as the main knife illustrated in  FIG. 1  except that each of walls  21   iv ,  22   iv ,  23   iv ,  24   iv  has convex knife edges  25   iv . The convex knife edges  25 ′″ allow the knife  20 ′″,  20   iv  to be gently rocked back and forth to facilitate cutting, for example, if resistance is met while pushing down on the knife  20 ′″,  20   iv . The margin knife  30  paired with either of the knives  20 ′″,  20   iv  may have similar knife edges  35  or may have different knife edges  35 . 
         [0040]    While each of the embodiments described herein have had an integral knife edge, it is contemplated that the knife edges may be connectable to a main body such that the knife edges are interchangeable and possibly disposable. Referring to  FIGS. 9 and 10 , an alternative main knife  20   v  will described. The main knife  20   v  includes a main body  16  defined by a plurality of walls  21   v - 24   v  which extend between an upper edge  26 , similar to the previous embodiments, and a lower connector edge  17 . The connector edge  17  is configured for connection to a blade assembly  18 ,  18 ′. The blade assembly  18  illustrated in  FIG. 9  includes a plurality of walls  15 , which complement the shape of the main body  16 , with each wall  15  having a connector edge  19  and a knife edge  25 . The blade assembly  18 ′ illustrated in  FIG. 10  includes a plurality of walls  15 ,  15   v , which complement the shape of the main body  16 , with each wall  15 ,  15   v  having a connector edge  19 , however, two of the walls  15   v  have a convex knife edge  25   v  and the other walls  15  have a linear knife edge  25 . The knife edges  25 ,  25   v  may have different blade configurations as described above. In each embodiment, the connector edge  19  is configured to removably connect with the connector edge  17  of the main body  16 , for example, through a snap-fit connection. Once the blade assembly  18 ,  18 ′ is selected and attached to the main body  16 , the main knife  20   v  operates in the same manner as described above. 
         [0041]    These and other advantages of the present disclosure will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the present disclosure. It should therefore be understood that this disclosure is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.