Abstract:
An assembly and method for the protection of medical personnel from accidental suture needle sticks is described. The assembly includes a case containing a needle which can be retracted when not in use. The needle is extended and retracted through the engagement of a needle driver which compresses a compressible member. The compressible member exerts a force on the needle which in turn extends the needle&#39;s point beyond the casing so that the user can suture tissue. Disengaging the needle driver retracts the needle point which protects the user from accidentally receiving a needle prick from a contaminated needle between punctures.

Description:
CLAIM OF PRIORITY 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/360,181, filed 8 Jul. 2016. The information contained therein is hereby incorporated by reference. 
     
    
     BACKGROUND 
     1. Field of the Invention 
       [0002]    The present application relates generally to a medical device, and in particular to a retractable suture needle assembly that prevents the incidence of accidental needle stick by the user. 
       2. Description of Related Art 
       [0003]    Injuries among healthcare personnel, due to sharps, is an area of concern because sharps pose a risk of transmission of blood-borne disease such as hepatitis B, hepatitis C and human immunodeficiency virus (HIV). A sharp is defined as an object with a fine point to poke a hole, such as a needle point, or a thin edge capable of cutting, such as a scalpel. The Center for Disease Control (CDC) estimates 385,000 sharps injuries occur annually among hospital based personnel. Sharps injuries represent a large expense both to the individual health care giver and the healthcare industry. Some of the direct costs of sharps injuries include laboratory testing and follow up treatment of the user, which is estimated to range between $71 to $5000 per person. If a disease is contracted as the result of a sharps injury, treatment of the disease as well as resulting lawsuits drive the cost even higher. 
         [0004]    Suture needles are involved in about 20% of sharps injuries. Current suturing equipment leaves the needle exposed while medical personnel are tying knots or disposing of the suture needle. Methods to prevent suture needle sticks include the proper disposal of the needles after use and the use of blunt-tip suture needles when suturing fascia and muscle. 
         [0005]    Although great strides have been made in preventing suture sticks, considerable shortcomings remain. A new system is required that ideally prevents suture needle sticks. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0006]    The novel features believed characteristic of the application are set forth in the description. However, the application itself, as well as a preferred mode of use, and further objectives and advantages thereof, will best be understood by reference to the following detailed description when read in conjunction with the accompanying drawings, wherein: 
           [0007]      FIG. 1  is top view of a retractable suture needle assembly prior to assembly. 
           [0008]      FIG. 2  is a front view of the retractable suture needle assembly of  FIG. 1  as assembled. 
           [0009]      FIG. 3  is a side view of the retractable suture needle assembly of  FIG. 1  as assembled. 
           [0010]      FIG. 4  enlarged side view of an inner casing of the retractable suture needle assembly of  FIG. 1 . 
           [0011]      FIG. 5  an alternative side view of the inner casing of  FIG. 4  with a needle extended. 
           [0012]      FIG. 6  is a flow chart for the use of the retractable suture needle assembly of  FIG. 1 . 
       
    
    
       [0013]    While the assembly and method of the present application is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the application to the particular embodiment disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the process of the present application as defined by the appended claims. 
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0014]    Illustrative embodiments of the preferred embodiment are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developer&#39;s specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. 
         [0015]    In the specification, reference may be made to the spatial relationships between various components and to the spatial orientation of various aspects of components as the devices are depicted in the attached drawings. However, as will be recognized by those skilled in the art after a complete reading of the present application, the devices, members, apparatuses, etc. described herein may be positioned in any desired orientation. Thus, the use of terms to describe a spatial relationship between various components or to describe the spatial orientation of aspects of such components should be understood to describe a relative relationship between the components or a spatial orientation of aspects of such components, respectively, as the device described herein may be oriented in any desired direction. 
         [0016]    The assembly and method in accordance with the present application overcomes one or more of the above-discussed problems commonly associated with conventional suture needles. Specifically, the retractable suture needle assembly is configured to assist in preventing an accidental needle stick when the suture needle is not in use. The suture needle is configured to selectively extend and retract into a casing when in use. These and other unique features of the device are discussed below and illustrated in the accompanying drawings. 
         [0017]    The assembly and method will be understood, both as to its structure and operation, from the accompanying drawings, taken in conjunction with the accompanying description. Several embodiments of the assembly may be presented herein. It should be understood that various components, parts, and features of the different embodiments may be combined together and/or interchanged with one another, all of which are within the scope of the present application, even though not all variations and particular embodiments are shown in the drawings. It should also be understood that the mixing and matching of features, elements, and/or functions between various embodiments is expressly contemplated herein so that one of ordinary skill in the art would appreciate from this disclosure that the features, elements, and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless otherwise described. 
         [0018]    The assembly and method of the present application is illustrated in the associated drawings. The assembly includes a three-part casing configured to surround a suturing needle and protect the user from an accidental needle stick. The assembly includes a mechanism to extend the needle out of the casing and allow the needle to retreat into the casing after use. The mechanism includes a needle driver in communication with an inner casing member and configured to flex under the application of pressure to selectively operate the suturing needle. The needle driver compresses a compressible member which exerts a force on the needle. The needle extends away from the casing when the compressible member exerts a force on it. In a resting state, the compressible member retracts the suturing needle. Additional features and functions of the device are illustrated and discussed below. 
         [0019]    Referring now to the drawings wherein like reference characters identify corresponding or similar elements in form and function throughout the several views.  FIG. 1  illustrates a top view of a retractable suture needle assembly  101  prior to assembly. The assembly  101  is comprised of a casing  103 , a needle  105 , a compressible member  107 , and a needle driver  109 . Assembly  101  is used to protect users from blood borne pathogens that may be passed if the user&#39;s skin is broken by a surgical instrument. Assembly  101  is configured to the approximate size of a normal surgical needle. 
         [0020]    The casing  103  is comprised of three sub-casings: outer casing  103   a , inner casing  103   b , and outer casing  103   c . In the current embodiment, casing  103   b  is coupled to casing  103   a  by a back hinge  111  and casing  103   a  is coupled to casing  103   c  by a front hinge  113 . Back hinge  111  is located adjacent to a suture end  115  of casing  103  (see  FIG. 3 ) and front hinge  113  is adjacent to a point end  117  of casing  103  (see  FIG. 3 ). Hinges  115  and  117  are used to pivot casings  103   a ,  103   b , and  103   c  into place. It is understood that casings  103   a ,  103   b , and  103   c  are connected by at least one hinge and the hinge may be placed in any location which facilitates the assembly of casing  103 . 
         [0021]    Casing  103  is assembled by the pivoting of casings  103   a ,  103   b ,  103   c  in a particular order. Casing  103   b  is configured to pivot about hinge  111  and rest against casing  103   a . Furthermore, casing  103   c  is configured to pivot about hinge  113  and rest against casing  103   b . When assembled in such manner, casing  103  is fully formed. Casings  103   a  and  103   c  are configured to cover opposing sides of casing  103   b . Casing  103  may be secured in an assembled configuration by any number methods. Examples of the types of couplings are interference fit, snaps, clips, fasteners, or tying by a line. If a line is used, the line may pass through interrelated holes  112  in each of the casing members. Casings  103   a ,  103   b , and  103   c  are selectively disassembled such that casing  103  can be more easily be cleaned or repaired as needed. 
         [0022]    The compressible member  107  is attached at one end to a base of needle  105  and at an opposing end it is coupled to casing  103   b . Therefore, compressible member  107  is in communication with both casing  103   b  and needle  105 . Needle driver  109  is also coupled at one end to casing  103   b  above compressible member  107 . A user engages driver  109  to compress the compressible member  107  to selectively position needle  105  between an extended position and a retracted position. Until the user engages driver  109 , point  105   a  of needle  105  remains retracted within casing  103  and the user is protected from an accidental needle prick. Needle  105  is used to pierce tissue and create a hole for the suture  119  (see  FIG. 2 ) to transition through. 
         [0023]    Referring now also to  FIGS. 2-3  in the drawings, a front and side view respectively of assembly  101  are illustrated. Casing  103  is depicted in  FIGS. 2-3  with a suture  119 . Suture  119  is comprised of any material commonly used in surgical suturing. In the current embodiment, casing  103  is assembled by pivoting casing  103   b  about hinge  111 , and then pivoting casing  103   c  about hinge  113 , such that casing  103   b  is situated between casings  103   a  and  103   c . While casing  103  is depicted to be formed from three pieces, casing  103   a ,  103   b , and  103   c , it is understood that casing  103  may be formed by combining any number of sub-casings together. Additionally, hinges are placed at locations needed to facilitate the formation of casing  103 . 
         [0024]    As seen in particular with  FIG. 3  in the drawings, casings  103   a  and  103   c  are notched in the same relative location creating a cut-out  121   a  and  121   b . Cut-outs  121   a  and  121   b  are equally located along the perimeter of casing  103  on opposing sides of driver  109 , such that driver  109  is fully exposed. Cut-outs  121   a  and  121   b  facilitate the user&#39;s engagement of driver  109 . As also seen in  FIG. 1 , casings  103   a ,  103   b , and  103   c  have matching holes  112 . Holes  112  are aligned with each other when casings  103  is formed so as to extend all the way through casing  103 . 
         [0025]    As seen in  FIG. 2 , needle  105  has a rectangularly shaped point  105   a . It is understood that the shape of needle  105 , and its point  105   a , may be configured in additional shapes, including round, oval, and triangular. The shape of needle  105 , and its point  105   a , are configured to facilitate the purpose of creating a hole for suture  119  to transition through. 
         [0026]    Suture  119  attaches to casing  103  at suture end  115 . Suture end  115  is located opposite from the point end  117  of casing  103 . Suture end  115  provides a place for suture  119  to communicate to casing  103 . It is understood that suture  119  will communicate to casing  103  in a fashion commonly used in the surgical community. 
         [0027]    Referring now also to  FIGS. 4-5  in the drawings, enlarged views of casing  103   b  with needle  105  retracted and extended, respectively, are illustrated. In this embodiment, driver  109  is depicted as a single tab flexibly coupled to casing  103   b . The coupling is located at one end (base end) of the driver and allows the user to engage the driver  109  such that driver  109  selectively compresses the compressible member  107  when engaged upon by a user. A notch  110  is located adjacent its base end to aid in facilitating is flexure. It is understood that driver  109  may be attached at different locations on casing  103   b  or casings  103   a  or  103   c . Additionally, driver  109  may be flush with the outer contour of casing  103  or it may be raised above the outer contour of casing  103 . Driver&#39;s  109  configuration will facilitate the user&#39;s ability to engage or disengage with driver. 
         [0028]    In this embodiment, compressible member  107  is attached at one end to a base of needle  105  and at an opposing end it is coupled to casing  103   b . The compressible member  107  is configured to locate needle  105  between an extended position and a retracted position. As depicted, member  107  is a wave spring with one or more waves. In operation, as driver  109  is flexed, member  107  is compressed between driver  109  and a bottom inner surface  123  of casing  103   b . Compression of the waves results in the lengthening of the spring which in turn translates needle  105  through a passaged formed by casings  103   a ,  103   c , bottom inner surface  123  and an upper inner surface  125  of casing  103   b . When driver  109  is unflexed, the waves of member  107  return to their relaxed and shortened length which in turn locates needle  105  back in a retracted position.  FIG. 4  shows the retracted position wherein point end  105   a  is located within casing  103 .  FIG. 5  shows the extended position wherein point end  105   a  is located outside of casing  103 . 
         [0029]    Of note, point  105   a  is not depicted as being flush with the point end  117  when extended. It is understood that point end  117  can be configured such that point  105   a , when extended, and point end  117  are flush and create a smooth transition. Casing  103  at point end  117  can be selectively tapered and contoured to maintain a smooth transition between needle point  105   a  and casing  103  when needle  105  is extended. 
         [0030]    Referring now also to  FIG. 6 , demonstrating the method for operation of the retractable suture needle assembly. The user obtains a retractable suture needle assembly, step  201 . If the assembly is not assembled, the user assembles the retractable suture needle assembly by pivoting parts of the casing on hinges, step  203 . The user releasably couple the casing parts together, step  205 . It is understood that the casing parts can be secured together through any method commonly used, such as interference fit, snaps, clips, fasteners, or tying by a line. When desired, the user extends the needle point beyond the casing by engaging the needle driver, step  207 . The user engages the needle driver by applying pressure to the needle driver either by squeezing the needle driver and casing between the user&#39;s fingers or a type of surgical tool. It is understood that the pressure applied to the needle driver compresses the compressible member between the needle driver and the bottom interior surface of the casing. The compression results in the compressible member exerting a force on the needle which pushes the needle point away from the casing. Once the needle point is extended, the user can use the retractable suture needle assembly, like a normal surgical suture needle, to suture together organic tissue, step  209 . Once the user is finished with suturing, the user retracts the needle point by disengaging the pressure from the needle driver, step  211 . 
         [0031]    The current application has many advantages over the prior art including at least the following: (1) The needle point can be retracted when needed; (2) a reduction in the risk of an accidental needle puncture which can result in the transmission of blood-born pathogens; and (3) it is easy to use due to its similar size and shape to a standard suturing needle. 
         [0032]    The particular embodiments disclosed above are illustrative only, as the application may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. It is therefore evident that the particular embodiments disclosed above may be altered or modified, and all such variations are considered within the scope and spirit of the application. Accordingly, the protection sought herein is as set forth in the description. It is apparent that an application with significant advantages has been described and illustrated. Although the present application is shown in a limited number of forms, it is not limited to just these forms, but is amenable to various changes and modifications without departing from the spirit thereof.