Abstract:
A scalpel for performing complex surgeries, such as c-sections, is formed of a body that is preferably elongated and shaped and sized to fit ergonomically into the hands of surgeons. The body has surfaces that are joined to each other by smooth transition elements to insure that the body has no points or sharp edges that could cut or scratch the surgeon or the patient. The body is formed with a triangular notch formed of a beak and an extension. A surgical blade, preferably a standard off-the-shelf surgical blade, is imbedded in the body and the only portion of the blade that is accessible is a portion of its cutting edge spanning the notch. The scalpel is used by introducing the beak into a slit in the tissue with the blade portion facing the direction in which the cut is to be made. The body of the scalpel is then grasped firmly and advanced to make the cut. The initial incision can be made with the tip of the beak.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. provisional application Ser. No. 60/886,191 filed on Feb. 5, 2007 and incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to devices for performing obstetric surgery, and more particularly to a novel device for performing incisions for a caesarian operation, as well as other similar surgical procedures or operations. 
         [0004]    2. Description of the Prior Art 
         [0005]    Many surgical procedures require one or more incisions to be made in the skin of a patient to provide access to the respective organ requiring active intervention. Additional incisions may be required in the internal tissues as well. For example, a caesarian section (c-section) is started by making an incision at the level of the pubic bone. Additional incisions are made in the walls of the uterus to allow a physician to remove the fetus. At the present, these incisions are made typically with a standard scalpel. However, this accepted technique has been found to be undesirable for several reasons. One reason is that it is hard to control the depth of the cut being made. If the incisions are too deep, they may result in injury to the fetus. 
         [0006]    In addition, in the current method a physician uses the blade tip of the scalpel to make the initial cut in the uterine wall and then reverses the scalpel to make an additional puncture. The physician could get injured while he is reversing the scalpel. Moreover, during the actual cutting phase, the physician typically uses his fingers to guide the scalpel along the uterus wall. However, existing scalpels have many sharp edges and points that can injure the physician, the mother or the fetus while the incision is made. 
         [0007]    A further disadvantage of existing scalpels is that they are fairly narrow, thin and slippery and ergonomically unfit to hold, especially with a gloved hand, especially after they are covered with body fluids. As a result they are not really suited for operations, such as c-sections, requiring complex and detailed manipulations. 
         [0008]    What is needed is a small, light-weight device for performing c-sections or other complex surgeries that can be used safely and effectively by physicians. 
       SUMMARY OF THE INVENTION 
       [0009]    The present invention is a device for performing incisions associated with c-sections and other surgical procedures. It consists of a body which is sized and shaped so that it can be held securely and comfortably by a physician. It includes a body forming a beak used to make an initial puncture in the skin or other membrane. The beak is then inserted into the resulting hole and is advanced, causing the blade to make an incision of a desired length. As the incision is made, a bottom surface of the beak insures an adequate separation between the cutting blade and the underling tissue, thereby preventing undesirable damage to the physician, the mother or the fetus. Preferably, the scalpel is formed of a body having no sharp points or edges and having an ergonomic shape that facilitates different kinds of manipulations. The scalpel can be used for c-sections, laparoscopic procedures, etc. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a side view of one embodiment of the cutting device constructed in accordance with this invention; 
           [0011]      FIG. 2  is a perspective view of the cutting device of  FIG. 1 ; 
           [0012]      FIG. 3  is a cross-sectional view along line  3 - 3  of the cutting device of  FIG. 2 ; 
           [0013]      FIG. 4  is a side view of a first alternate embodiment of the invention; 
           [0014]      FIG. 5   a  shows a side view of a second alternate embodiment of the invention; 
           [0015]      FIG. 5   b  shows a front view of the embodiment of  FIG. 5   a;    
           [0016]      FIG. 5   c  shows a top view of the embodiment of  FIG. 5   a;    
           [0017]      FIG. 6   a  shows a side view of a third alternate embodiment of the invention; 
           [0018]      FIG. 6   b  shows a front view of the embodiment of  FIG. 6   a;    
           [0019]      FIG. 6   c  shows a top view of the embodiment of  FIG. 6   a;    
           [0020]      FIG. 6   d  shows an enlarged top view of the beak area of the embodiment of  FIG. 6   a;    
           [0021]      FIG. 6   e  shows an enlarged front view of the beak area of the embodiment of  FIG. 6   a;    
           [0022]      FIGS. 6   f - 6   i  are cross-sectional views taken along lines A-A, B-B, C-C, D-D respectively in  FIG. 6   c;    
           [0023]      FIG. 6   j  is a partial orthogonal view of the beak of the embodiment of  FIG. 6   a;    
           [0024]      FIG. 7   a  shows a front view of the embodiment of  FIG. 6   a  in a first position used to make the initial puncture for a surgery operation; 
           [0025]      FIG. 7   b  shows a front view of the embodiment of  FIG. 6   a  in a second position for starting the cut in the wall of the uterus; 
           [0026]      FIG. 7   c  shows a front view of the embodiment of  FIG. 6   a  in a third position for actual making the cut; 
           [0027]      FIG. 7   d  shows the scalpel in the position of  FIG. 7   c  further indicating the fingers of the physician; and 
           [0028]      FIG. 8  shows a partial orthogonal view of another embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0029]    Referring first to  FIGS. 1-3 , a device  10  for performing incisions for a c-section includes a generally oval body  12  having a width  14  and a height  16  of about 50-80 mm and a thickness of about 3-6 mm. Other dimensions and shapes are suitable as well, as long as the device is light and comfortable to hold. The body is made with a triangular notch  18  forming a beak  20 . The beak  20  is terminated with a rounded point  22 . The notch holds a cutting blade  24  formed with a sharp edge  26 . 
         [0030]    The device  10  is used as follows. First, the tissue is punctured with the point  22 . The beak  20  is then inserted through the resulting hole and advanced until the lateral side of the hole (not shown) is reached by the edge  26 . The device is then advanced causing the edge  26  to make a clean incision of the desired length. While the skin or other membrane (e.g., the uterus) is being cut during this process, a lower surface  30  of the beak  20  separates the tissues of the organ or the fetus disposed immediately beneath and insures that a minimum spacing is maintained, thereby preventing any incidental damage. To ensure that device  10  cannot cut the physician, mother or fetus, surface  30  is either round or flat. Moreover, the size and shape of the device insures that a physician does not prick or cut himself during surgery. 
         [0031]    The device can be made from a single solid material. However, it is preferably to have the body  12  made of a suitable plastic material that is easy to make, using well known molding or other techniques, and is easy to sterilize. The cutting blade can be made of surgical steel or other similar materials and can be either imbedded in the body  12  during molding or can be attached later. 
         [0032]    In  FIG. 4 , an alternate device  32  is shown with an elongated body. This shape may be preferred by some physicians because it is similar to a traditional scalpel and therefore may look more familiar. 
         [0033]    Studies were conducted with several physicians to ergonomically optimize the shape, size and configuration of the scalpel. Two such configurations are described below.  FIGS. 5   a - 5   c  shows one such embodiment. In this embodiment, scalpel  50  an elongated curved body  52  that is rounded at one end  54  and a triangular notch  56  at the other end. The notch  56  is formed between the beak  58  and an extension  60 . Beak  58  terminates in a rounded point  62 . As seen in  FIG. 5   b , the beak  58  has a triangular cross-section thicker at the bottom than the top. This novel shape insures that the point  62  is strong and does not deflect when used to apply pressure and pierce a tissue or membrane of the patient as discussed above. The extension  60  is shorter then the beak  58  to provide good viewing angles of the blade and of the portion of tissue being cut. 
         [0034]    The body  52  has two identical lateral surfaces, one such surface  70  being visible in  FIG. 5   a . This surface is formed with a peripheral rim  72  separated from a central depression  74  by a rounded ledge or rail  76 . This rounded ledge or rail  76  can be used to easily grasp, push or pull the scalpel  50 . Prior art scalpels do not possess any such features. 
         [0035]    The central depression  74  is formed with a plurality of parallel vertical ridges  78 . As seen in  FIG. 5   a , when the scalpel  50  is oriented so that its lowest point  80  is tangential to an imaginary horizontal surface  82 , the ridges  78  are perpendicular to the horizontal surface  82 . When the scalpel is used, the imaginary surface  82  is parallel to the tissue  84  being cut. Therefore, the ridges  78  provide the physician with an indication of how the scalpel  50  is oriented with respect to the tissue  84 . 
         [0036]    Preferably near the rounded end  54 , the depression  74  has a flat or blank area  86  that can be used to provide a logo, a model number, etc. 
         [0037]    Scalpel  50  has a top edge  88  that is formed near extension  60  with several protrusions  90 . The protrusions  90  provide more friction when the physician has to apply pressure on edge  88  with a finger during a procedure. The top edge  88  and the bottom edge  89  form longitudinal edges for the scalpel  50  and are curved to provide the scalpel with a body that is easy to grasp. The curvature of the edges and the protrusions  90  provide the physician with a clear indication of the correct orientation for the scalpel  50  during surgery. 
         [0038]    An important part of the scalpel  50  is blade  92 . Preferably the body  52  is molded from a plastic material over the blade  92  and therefore in  FIG. 5   a  only a portion  94  of the cutting edge of the blade is visible. This portion  94  can be straight, convex or concave. Returning to  FIG. 5   c , near its forward end, the edge  88  is formed with a knife indication  96  in the form of a line or depression corresponding to the position of the portion  94 . Therefore the indication  96  assists the physician in determining the exact position of the cutting edge portion  94 . 
         [0039]    Preferably, the body  52  has an overall length of about 3-5″, and more particularly between 4.800-5.00″, because range can accommodate physicians with hands in the range of 6-8″. The width of the body can range between 0.800-1.000″ and a thickness of between 0.150 and 0.250″. The present inventors have found that a scalpel having a body of about 4.82″ in length, a width at point  80  of 0.916″ and a maximum thickness of 0.200″ is particularly advantageous. 
         [0040]      FIGS. 6   a - 6   j  display another embodiment of the invention similar to the one in  FIGS. 5   a - 5   c . In the embodiment just described, the inventive device has a somewhat uniform width, except at the forward end. In this latter embodiment, the scalpel  100  is tapered so that it is wider near the rounded end  102  and then near the notch  104 . The scalpel  100  is also thicker. The preferred dimensions of the scalpel  100  are 4.863″×0.916″ (at point  124 ) ×0.250″. Thus, overall this latter embodiment provides a heftier feel. Moreover, the extended width results in longer grooves  106  to accommodate hands of different sizes as well as more positions for the hands on the scalpel  100 . 
         [0041]      FIG. 6   a  also shows the outline of the blade  110  with its visible cutting edge portion  112 . Preferably blade  110  is a standard surgical blade that is readily available from numerous sources. In the figure, blade  110  is a No. 23 blade with an elongated cutout  114 . Other blades can be used as well. Alternatively, a custom designed blade may be used. Of course, such a blade may increase the cost of the scalpel. 
         [0042]      FIGS. 7   a - 7   c  illustrate how the embodiments of  FIGS. 5   a - c  and  6   a - d  may be used to perform a c-section. In  FIG. 7   a  the physician positions a scalpel (e.g.  100 ) as shown. The angle A may be in the range of 75-80 degrees and preferably about 77 degrees. The scalpel is used in this position to puncture the wall of the uterus U. If the wall is too thick, the physician may cut a small (1″) opening therein with a standard scalpel. The beak  120  is then positioned under the wall U at an angle B in the range of 35-40 degrees and preferably 38 degrees. The scalpel  100  is designed so that it is comfortable to hold in this position. Because the extension  122  is shorter then the beak  122 , the cutting edge  112  is visible to the physician from the top. The physician then rotates the scalpel  100  until it reaches an angle C of about 15-25 degrees and preferably 20 degrees, and starts advancing the scalpel. In this position, the beak  120  pushes the wall U slightly upward and ready to be cut by the edge  112 . While this motion is continued, the sharp edge  112  cuts the wall U smoothly and the point  124  insures that the scalpel passes smoothly over the fetus and that the fetus is not injured.  FIG. 7   d  shows the scalpel of  FIG. 6   c  in the hands of the physician. The circles, e.g. circle  130 , indicate the position of the physician&#39;s fingers during this step. 
         [0043]    As discussed above, the body of the scalpel is overmolded on the standard surgical blade from a suitable plastic material. Except for the cutting edge of the blade, the body is formed with surfaces that are joined with rounded transitions with a nominal radius of about 0.030″ to insure that it presents no sharp edges or points. In this manner, the scalpel prevents injuring and infecting the physician, the patient and the fetus. The body can be provided in colors different from those of other instruments or in particular colors for different hospitals and departments to avoid confusion. The body can also be made of, or include, a compound visible by x-rays so that after the surgery is completed, the patient can be x-rayed to insure that the scalpel has not been left in the patient inadvertently. The device is made preferably of relatively cheap materials so that its manufacturing costs are reduced and so that it can be discarded, either after each use, or after each procedure. 
         [0044]    Another embodiment of the invention is shown in  FIG. 8 . In this embodiment a scalpel is shown having a body  160  similar to the ones in  FIG. 5  or  6 ; however it does not have an imbedded steel blade. Instead, the base notch is shaped so that a plastic blade  162  is formed between the extension  164  and the beak  166 . The blade has to be hard enough to be able to cut tissues, just as described above. The blade  162  is made integrally with the body  160  in a single molding operation. 
         [0045]    In summary, the present invention presents a disposable surgical scalpel, such as an obstetrical scalpel, which aids in safer c-section deliveries by reducing knife injuries made from scalpel blades. Manufactured from a strong, break resistant plastic material, such as Lexan®, with a surgical blade embedded within, the scalpel provides enough resistance to pierce through the last tissues of uterine and amniotic tissue and cleanly cut across the uterus without lacerating the baby. Briefly, in the context of Caesarean section delivery, the factors that need to be taken into consideration when designing such a scalpel are: safety, performance, intuitiveness, and construction. The present scalpel has been designed with these factors in mind, as illustrated below. As a result, these factors provide a framework that renders the surgical scalpel very useful and unique. 
         [0046]    Safety:
   1. No knife lacerations made on baby due to unique piercing tip and embedded blade for a quick, clean incision.   2. Intuitive hand position increasing grip and control, decreases mis-use.   3. Clear sight lines over cutting edge.   4. Grip provides close proximity to blade to avoid loss of control while cutting.   5. Iconic shape, easily identifiable on the tool field.   6. Arrives to the Operating Room sterile, packaged, ready for surgery   7. Disposable post surgery   
 
         [0054]    Performance:
   1. Grip utilizes all fingers to increase control   2. Unique handle and blade configuration that pushes through the tissue like a scissor.   3. Ribbing perpendicular to cutting path increases grip.   4. Unique handle shape allows surgeon to back off or move up on tool, thereby increasing control and sight lines to cutting path.   5. Unique round edged tip will pierce through layers of tissue   6. Specific hand and tool position increase control and accuracy of incision.   7. Embedded surgical blade creates clean path through uterine tissues.   8. Increased sight-lines over cutting edge will decrease chance of vascular injury to mother.   
 
         [0063]    Intuitiveness:
   1. Iconic shape will not be confused for something else on the surgical tool field.   2. Grip discourages a downward piercing action, or an “ice pick” action due to it&#39;s unique grip and intuitive hand position   3. Tool can only be held two ways, pinched or grasped.   4. Clear sight lines provide a safe range of movement and motion through the uterine tissue.   5. Unique “jaw” opening provides visual description of approximate tissue cutting depth.   6. Identifiable shape, won&#39;t be confused with another tool.   
 
         [0070]    Construction:
   1. Economical use of materials   2. Blade inserted into tool and cast into plastic C-Safe handle   3. Innovative break-resistant plastic   4. X-Ray opaque if lost of broken during surgery.   
 
         [0075]    Numerous modifications may be made to this invention without departing from its scope as defined in the appended claims.