Patent Application: US-58869105-A

Abstract:
suture needles are a significant safety hazard for medical workers , mainly because of accidental needlestick injuries . disclosed herein are safety suture needle assemblies and related methods . in particular , variations of a safety suture needle having an activatable sheath or flexible extension member are disclosed . the implementation of certain embodiments of the disclosed invention can result in a desired improvement in safety , including the prevention of unwanted needle punctures , while achieving efficient suturing .

Description:
the invention may be further understood by the following non - limiting examples . the disclosure herein , including the accompanying drawings , illustrates the variety of embodiments for needles , the activation mechanisms ( e . g . an sma assembly ), and means for activating the activation mechanism . in an example , a needle holder serves not only to physically assist in holding the needle but also functions as a means for activating the activation mechanism . in an embodiment , a known needle holder can be modified with an attachment , or a presented novel needle holder can be used to activate the activation mechanism . in particular to take advantages of properties of sma material , other modes of activation are included . the drawings also illustrate various configurations of certain parts that may be useful in various sma mechanisms . a particular configuration can be selected according to manufacturing possibilities , standardized regulations on durability , and consumer preference . multiple possibilities and varieties of construction for an sma mechanism of activation are also illustrated . for the sma mechanism of activation , two options are used . the choice of option can pertain to the method of construction of the device . if the needle is to have reversible on / off characteristics as described , the needle can incorporate a force exertion assembly . in the drawings , such a force exertion assembly is illustrated as a spring analogous to a conventional extension spring . a spring can be optionally constructed of any applicable and acceptable medical grade metal alloy . the spring is not necessarily confined to a metal spring configuration but can be constructed of a polymer material or configured by many other widely accepted means of placing a rebound tension on the activation mechanism itself . if a needle of the invention does not incorporate on / off characteristics but namely has a one time or one way activation characteristic , a spring assembly may be optionally excluded . in a configuration where a spring is excluded , the activation mechanism relies solely on the properties of the sma material to return to its preformed shape in order to exert the linear extension of the sheathing assembly to achieve a protective position such as over the needle body . an example of a situation where a spring is optionally included is as follows . a certain amount ( e . g . a short or limited amount ) of retraction may be desired to secure the tip firmly within a resting point / position , or a sheathing guard point / position within the sheath itself , as to entirely secure and encompass the sharp point of the needle . if this short amount of retraction is utilized to accomplish the desired effect , a small compression spring may be internally attached to the sheathing assembly or the mechanism of activation itself , in order to provide the retraction desired . elements of the needle body itself are represented as being of a suitable metal or alloy , optionally of acceptable standards . for certain device embodiments , elements of the needle body may need to be insulated from the electrical current which passes through it ; high density polymers may be used to construct the outer needle body , or any of the other parts , depending on manufacturing tolerances and the design deemed as most desirable . the general representation of the entire needle assembly can involve a hollow casing with certain parts resting inside the casing and certain other parts oriented around the inner parts so as to allow an electrical current to flow through efficiently , thereby facilitating a process of ohmic heating or so as to allow thermal heating by thermal conduction . particular embodiments of the invention , however , are not limited to the only internal placement of certain parts . particular variations for the needle assembly can allow construction and position of parts / elements at different points about the body of the needle assembly . namely , it is possible to have the extension sheath externally located ( e . g ., as opposed to integrally flush with the needle body ), and also it is possible to design the mechanism of activation as an externally attached unit separate from the main needle body itself , for example the sma mechanism could run proximally to the suture material , distally from the tip of the needle . the sheathing mechanisms shown support how to accomplish the sheathing / blunting effect desired ; however , the mode of sheathing and / or blunting can also be achieved by other manifestations . for example , an externally placed sma wire can run along the top side of the needle assembly ; when treated such as by heat , the wire can return to a performed shape such as one that reaches a protective position at least partially covering the sharp point of the needle tip . fig1 illustrates a general needle body of a needle assembly of the invention . the shown needle shape is divided into three sections , the distal needle tip area in general represented by fig3 - 8 , and each figure of the grouping 3 - 8 provides specific detail on a variety of possible sheathing / blunting assemblies . it is implied but not necessarily shown in certain diagrams that there can be a linear extension shaft that runs along a longitudinal axis within a cannula of the needle body , which connects the sheathing assembly to a mechanism of activation . in some representations of the present invention , the sheathing body is designed so as to be part of the extension shaft itself . the shown needle shape in fig1 is further divided into a middle section for clarity and is shown in greater detail in fig9 - 10 with mechanisms of activation . another subdivision of the general needle is the proximal end with respect to an attachment point for the suture material and is detailed in fig1 . generally these figures illustrate various ways to construct the external needle casing and attach the suture material to the needle body itself . one of ordinary skill in the art will appreciate that the parts can be constructed , joined , and manufactured by various techniques including commonly known practices . the four figures grouped together as fig1 i , fig1 j , fig1 k , and fig1 l are presented occasionally throughout the drawings to clarify functional characteristics of the activator or mechanism of activation in relation to the needle assembly and whether or not activation of the activator is initiated by an initiator such as heat 1 j , electricity 1 k , or whether the activator is in a rest or default state with no heat or electrical energy being administered to it . the fig1 i refers generally to the presence of a blunting / sheath mechanism , and is shown occasionally throughout the drawings to reference the presence and or location of the blunting / sheathing assembly . fig1 e - 1h illustrate usage of the needle assembly device . fig1 e represents the passing of the device between two persons and conveys the safe attribute of the blunted characteristic of the needle during transport ( the tip variation of fig8 is depicted solely for example ). fig1 f shows the common practice of loading a needle assembly by an operator onto an art - known needle holder ( further illustrated in fig2 . 1 ) and shows the blunting characteristic of this specific example . fig1 g shows usage of the needle assembly in a common medical practice of tissue penetration or suturing with the sheathing / blunting blunting assembly ( of the fig8 variation ) in an armed state . here activation is achieved by an operator &# 39 ; s left hand depressing a control button which is explained in the fig2 set . fig1 h shows the release of the said control button and the result of deactivation or disarming which renders the needle assembly less likely to cause an accidental puncture . it is possible to begin the process of activation with either hand and from any angle ( see fig2 . 3 a , fig2 . 3 b ); for example , multiple switches can be incorporated . the following describes some of the properties of the mechanism of activation and illustrates embodiments of the invention . see fig9 a - 9q ( in particular fig9 a , fig9 b , fig9 c , fig9 d , fig9 e ( shown as encompassing aspects of fig9 a and fig9 c ); fig9 f ( shown as encompassing aspects of fig9 h , fig9 j , fig9 o ); fig9 g ( shown as encompassing aspects of fig9 l , fig9 n ). the figures within fig9 a represent the characteristic of the sma to be at rest with a preformed shape . fig9 a depicts an internal nitinol wire ( not shown ) inside a spring , where the spring is capable of exerting an opposing force to that of a force exhibited by the nitinol wire either when contracting or returning to an original position / shape . during a heat annealing process the alloy is raised to a temperature above its transition point , and then deformed at that point . upon cooling , the alloy is then deformed again to the desired shape . when the alloy is heated at a later time , it has the special property to return to its previously set shape that was formed during the annealing process . fig9 o then shows the linear movement desired of the mechanism of activation with the application of heat or electricity to the material . the vertical column within the brackets of 9 g represents the length of the horizontal placed material . the vertical column of fig9 f represents a displacement distance that the sheath / blunting mechanism and / or extension assembly travels to reach a position at which the sheath / blunting mechanism is effectively protective with respect to the sharp aspect of a sharp object . the vertical column of 9 e represents a linear component of a spatial region where the sheathing / blunting mechanism is acting in a protective fashion . fig9 b illustrates a general needle shape in reference to its blunting / sheathing assembly , characteristics of the said assembly shown in fig9 a , and the location of the said blunting sheathing assembly relative to the sharp needle tip . within fig9 b , fig9 p illustrates a configuration at rest ; fig9 q illustrates an activated configuration ; the intended direction of travel of the sheathing / blunting mechanism during activation towards the activated state ( here disarmed ). fig9 c illustrates the properties of the mechanism of activation with an extension spring for linear extension . fig9 h represents the needle assembly at rest with the sma material at the inner core of an assembly of the sma material and the spring . in a preferred configuration there are two connection points between the sma component and the spring component of the assembly ( such as at opposite ends of the sma component ). fig9 l shows the contraction / retraction of the sma material , which ranges from about 6 %- 10 % of its overall length upon application of energy input to the sma material . the sma material contracts in length , and its diameter increases in a corresponding range . this fact is taken into consideration when constructing and inserting the activation mechanism assembly ( and optionally a separate extension shaft , etc .) into the needle . fig9 j shows the extension of the sma material by the force exerted upon it by the extension spring . the vertical column within the brackets of 9 g represents the length of the horizontally displaced sma material ( or sma and spring assembly ). the vertical column of fig9 f represents the distance that the blunting mechanism and / or extension assembly has to travel to reach the point at which it effectively acts as a blunting / sheathing mechanism . the vertical column of 9 e represents the area at which the sheathing / blunting mechanism is acting effectively with its purpose to at least partially shield the sharp object tip . fig9 d illustrates a general needle shape and orientation of location with respect to its blunting / sheathing assembly , the sma / spring assembly described in fig9 c , and how the blunting / sheathing assemblies location is affected in each state ( rest , activation , returning to rest ) and process ( compression / extension of spring , contraction / expansion of sma material , and relative displacement of length ). fig9 k shows the sheath at rest , fig9 l shows the sheath being retracted during activation , and fig9 m shows the sheath being extended by the extension spring . a general suture needle is illustrated in fig3 and shows a radial / cylindraceous sheath assembly 3 q protruding distally from the needle , rendering the sharp point at least partially covered so as to protect the operator . fig3 a shows the same general needle with sheath 3 q at its retracted position . fig3 a - 3i show specific defined views and the relation of the said parts to the assembly . the sheath has a vertical channel 3 j which allows for the expansion 3 p of the sheath in order to displace or slide over the needle tip upon retraction or extension ( see fig3 i ). sheath 3 q comes to rest within the notch or space 3 r which is formed from the main needle body . channel 3 j meets the elevated ridge 3 o which is formed from the main needle body , in order to secure the sheath during its various sequences . the sheath 3 q is attached or is itself a unitary part of slider shaft 3 k , which runs through an aperture 3 n within the needle body itself 1 c to the inner cannula 1 d where slider shaft 3 k is attached to a mechanism of activation ( see various fig1 ; fig1 , fig1 i , fig1 j , fig1 k , fig1 l ). sheath 3 q has a slightly rounded edge on the superior portion 3 l so as to prevent the formation of an additional puncture hazard and also to allow for easy passage from notch 3 r to its extended position . the edges of notch 3 r including a tip proximal notch leading edge , a trailing edge , and / or edges near raised ridge 3 o are made smooth ( not shown ) to facilitate the ease of transition of sheath 3 q to move freely from the extended to the retracted position . the sheath 3 q is stopped and makes a snug or tight junction upon meeting element 3 m which is a resting ledge that is preferably substantially uniform . the sheath assembly disclosed can be adapted or modified to fit sharp object tips of a variety of tip sizes , shapes , and characteristics . a general suture needle is illustrated in fig4 and shows a sheath assembly 4 v protruding distally from the needle , rendering the sharp point covered so as to protect the operator . fig4 a shows the same general needle with sheath 4 v at its retracted position . fig4 b , fig4 c , fig4 d , and fig4 e illustrate specific defined views of the assembly and the relation of the parts to the assembly and needle tip 1 a . the shield - like sheath 4 v has a point or recess 4 x on the bottom of the sheath . when the shield 4 v moves over the needle tip ( such as when used in the context of one time activation with a retraction spring 10 h { see fig1 } within an assembly of the mechanism of action of fig1 ), the needle tip comes to reside within a sharp tip catching point , element 4 x , which “ locks ” the shield 4 v on to the needle tip 1 a . the shield 4 v is blunted or slightly rounded with an arch or hood , element 4 y , about its outer perimeter , so as to not produce an unnecessarily hazardous sharp aspect in addition to the primarily hazardous tip . shield 4 v is then connected to an extension 4 w or is uniformly constructed as part of the extension itself . the extension 4 w is then connected to the mechanism of activation ; see various fig1 . the shield 4 v upon retraction comes to reside within a notch or aperture 4 u of the main needle body . upon retraction the shield and needle body 1 c form a radially substantially uniform body , so that there is minimal opportunity for catching or unwanted drag from the needle during passage through tissue . in a preferred embodiment the entire needle is substantially flush or smooth with the shield in the retracted position . fig4 f shows a side view of the aperture 4 u in relation to the needle body . the shielding mechanism and aperture are located close enough to the tip 1 a so as to equate the amount of travel given from the extension and contraction of the assembly of activation and also so that the tip is not weakened by the aperture being placed to close to a narrow portion of the needle tip , which could possibly weaken the tip and needle body . in order to guide the shield to its proper orientation upon retraction and or extension , an optional groove can be placed within or along the needle body and distally to the aperture that matches the extension shaft . when the activation or activation and extension mechanism is in movement , the groove would facilitate orientation of the shield into its proper alignment . fig4 g , 4h , and 4 i show in detail the shielding mechanism and extension shaft . the extension shaft 4 w has one or more “ catch points ”, element 4 z , to reduce flexion of the shield if force is applied to the shield that may displace the shield to a spatial region away from a protecting position . the catch points 4 z are accepted by grooves 4 aa disposed within the needle body so as to capture the sheath to facilitate the performance of the sheath in a secure manner . fig4 t gives a detailed view of resting points 4 z in relation to the catch point grooves 4 aa . the shield can optionally be formed so that no sharp tip catch point exists , and the needle can be reversibly activated and deactivated multiple times by the retraction and extension of assemblies shown in fig4 j - 4s . the sheath assembly disclosed can be adapted or modified to fit sharp object tips of a variety of tip sizes , shapes , and characteristics . a general round suture needle is presented in fig5 ( see also fig5 a - 5j ), illustrating and shows a preformed wire ribbon or loop assembly 5 n protruding distally from the top medial portion of the needle tip 1 a through two exit apertures 5 l and 5 m . fig5 a shows the same needle assembly with the sheath / blunting mechanism at rest or retracted into the main needle body . if the needle is initially supplied in the state depicted in fig5 with the sheath in a protective position with respect to the needle sharp end , this preset disarmed needle can then be activated to achieve an armed configuration with the sheath in a nonprotective position . fig5 b , fig5 c , fig5 d , and fig5 e show specific defined views of the assembly and the relation of parts to the assembly and needle tip 1 a . the sheath / blunting wire mechanism 5 n can exit as an optionally sole unit from the main body extension shaft through a secondary aperture 5 o , as two separate but joined wires to the main extension shaft . in this variation , the wire loop itself forms the extension shaft ( note fig7 n , showing the two ends of the wire , connected to a slider plate , which is really the mechanism of activation ). alternatively , the exit mechanism can have a plate 5 p covering the aperture that can have a single aperture or two apertures , 5 l and 5 m , depending on the formation of the preformed wire assembly 5 n . there are many variations of exit mechanism configurations for this type of sheath / blunting mechanism in the retracted and activated positioning of the wires ; a particular variation can be selected for purposes such as manufacturing efficiency or aesthetic considerations . fig5 i shows a transparent lateral view of a secondary aperture 5 o that is positioned at any angle to form an efficient and correct angle for exit of the sheath / blunting assembly . the blunting mechanism 5 n is located within the shown area can retract when activated to an accepting groove 5 k , and would rest at this location . fig5 h demonstrates that the sheath / blunting assembly 5 n can optionally have a characteristic of flexibility . the flexibility of 5 n can be useful during the spatial translocation of moving over the needle tip point in order for a tight joining of the wire and the needle body itself 1 a . the left panel of fig5 h shows a starting configuration of the sheath ; in the middle panel , the inset arrows are shown as extending outwardly to reflect the flexible outward extension of segments of sheath 5 n . the third or right panel has inset arrows pointing inwards relative to the sheath assembly to reflect the flexible inward extension of sheath 5 n segments . thus fig5 h demonstrates the potential lateral flexibility of the wire loop . fig5 g illustrates an embodiment of the needle assembly with a portion of sheath wire 5 n achieving substantial uniformity of surface continuity with a portion of needle body 1 c due to sheath accepting channel 5 k . in a preferred configuration , the accepting channel can receive substantially the entire sheath in a state that can optionally be referred to as a resting state or activated state depending on an initial preset condition of being armed or disarmed . the sheath 5 n can be constructed of suitable materials as known in the art . note that the sheath wire need not necessarily be constructed only of nitinol or other sma , nor does the sheath need to be constructed of the same material as extension shaft or activator components . the sheath wire can be plastic or nonplastic polymer . as in fig5 f , the sheath can have a full circle diameter shape such as a wire except optionally for a portion or segment that can rest within the accepting channel or groove which can be of a half circle shape . the sheath 5 n can alternatively be of any shape necessary to create in conjunction with the needle body a substantially uniform exterior so as to reduce drag or snagging of the wire ( fig5 g ). for example , the sheath can be flattened like a ribbon , or composed of segments with different shapes . a general round suture needle is presented in fig6 with a blunted rod 6 r having a blunt end surface 6 s that projects from the tip 1 a upon extension . the rod 6 r can be a wire , bar , beam , or other object such as a blunting means . the exiting projection of the blunt rod 6 r itself can be substantially along a hypothetically extended longitudinal axis of the sharp point tip 1 a so as to provide a blunting body that a surface would come into contact with primarily as opposed to the sharp tip of the needle . the surface here for example can be a patient surface , medical worker human or clothing surface , needle operator human or clothing surface , or surgical environment surface . the blunt rod tip can protrude in any direction or from any segment of the needle body and not just from the needle tip end in the single direction along a longitudinal axis of the needle body . fig6 a shows the blunted rod projection in a retracted position . in a preferred configuration , rod tip 6 s is blunted just enough so as to not act as another sharp area but not be so blunted to allow excessive drag or snagging of a tissue subject to penetration . the blunted projection can be a singular unit that connects to the mechanism of activation assembly ( fig1 ) or can comprise or connect to a lateral extension 6 t that connects to a general extension such as in fig1 . specific views are detailed in fig6 b , fig6 c , fig6 d , fig6 e , fig6 g , and fig6 h regarding the needle assembly and details . fig6 g illustrates a variation where the blunt rod has a curved or angled segment 6 q , so that upon extension / projection of rod 6 r the projecting rod has a spring - like characteristic to facilitate positioning of the rod 6 r and rod tip 6 s towards a protective position over the needle tip . upon retraction , a spring - like bending effect can be small enough so as to facilitate ease of retraction . in a configuration for one - way or reversible activation , the curved segment 6 q straightens sufficiently and fits snugly within the main lateral needle cannula 1 d . for a configuration with a one - time activation property , the blunted projection rod 6 r can further comprise a resting catch point groove ( or notch , aperture , channel , recession , or means for receiving ) shown in fig6 m and 6n . this catch point can serve to facilitate storage of the projecting blunt rod in a locked ( e . g . at least partially secured ) position and can be combined with the small retraction mechanism in order to fit the projection snugly on to the tip . in a variation , a small rebound tension mechanism is placed in the body of the needle in order to secure the needle tip into the “ pocket .” a second aperture 6 o can be formed as illustrated in fig6 f and positioned so as to allow an efficient exit angle for the projection rod . fig6 i - 6l show specific views of the needle assembly with detail . further embodiments of devices and methods can use an extending rod fixed at a point proximal to tip 1 a . in such embodiments , the rod is free to move vertically upon extension and also distally to cover the needle tip and provide a blunting effect ( see fig6 p ). fig6 p is an illustration of the conception and can be modified or adapted as taught herein and / or would be understood by one of ordinary skill . in fig6 p , a particular embodiment illustrates that by application of force along the rod against a fixed point towards the needle tip , a loop or segment of the rod material is pushed with vertical displacement from a needle longitudinal axis and with horizontal displacement along such axis , wherein the horizontal displacement is beyond the needle tip . in a variation , the rod is nitinol and integrated with the activation mechanism ( and integrated with distinct slider and extension components too , optionally ). a general round suture needle is presented in fig7 with a projection sheath 7 r which has a first end and a second end , where said first and second ends are fixed adjacently to a single point ( in other words , proximal and equal to each other ; see fig7 n ). alternatively , said first and second ends are fixed at a first lateral point and a second lateral point of the needle body , respectively ( and distal to each other ); see fig7 , and fig7 a - 7j . the sheath can be a wire loop . in the first variation both ends of the wire loop projection are attached at or near the same point ( fig7 n ); where the point is disposed along either the main general extension shaft or can directly connect to the mechanism of activation at a defined point such as segment 7 t . in a second variation , the two separated ends of the sheath extension can also be placed laterally , e . g . on directly opposite sides of the needle body , with separate exit holes / apertures 7 q . apertures 7 q are optionally substantially unitary with the main lateral cannula 1 d . fig7 m shows a closer view with details . in the second variation the sheath projection 7 r is fixed at the point of attachment to either a general main extension or the mechanism of activation at a sheath 7 r proximal end and at a lateral fixation point located on the needle body itself ( see fig7 o ). the design allows for a sheath / wire to expand laterally and then distally ; the sheath can have a preformed curved segment or shape that can extend in a manner as to provide the necessary blunting effect . for both variations , the sheath / wire is of a shape so as to correspond to a tightly fitting resting point 7 p ( see fig7 , et alia ) when retracted towards the main needle body . this is analogous to concepts described herein such as in various fig5 . fig7 l illustrates that a sheath , such as a wire ( of metal , plastic , or polymer , etc .) is shaped in one or more dimensions such as diameter to correspond to the needle body and resting groove 7 p . the placement of exit guide channel 7 s can be selected based on one or more factors such as efficiency of angle allowing activation and / or retraction , and manufacturing methods . similar to the concepts illustrated in various fig5 , a secondary guide channel with a plate covering and corresponding holes / apertures for the wire projection wire segments to exit can be implemented . fig7 h to 7 k illustrated detailed views of the assembly . in a variation , the sheath is nitinol and integrated with the activation mechanism ( and integrated with distinct slider and extension components too , optionally ). a general round suture needle is presented in fig8 with a break - away tip design where the tip breaks away from the main needle body upon activation or extension of the mechanism of activation . in a disarmed state , needle tip segment 8 l is tethered or suspended from the needle body 1 c by a flexible extension component 8 j and is generally able to move freely except for the tethering constraint at a needle tip segment end . fig8 a - 8f illustrate the assembly with various views . a distal tip 8 m of the needle body proximal to a break point has a force dissemination contact surface or blunting means so as to not provide a sharp surface in addition to the needle sharp tip . upon the retraction of the mechanism of activation , the needle tip can retract and be guided by a guide assembly . in one variation the guide assembly comprises a simple ridge and groove ( not shown ). in another variation there is an asymmetrically rigid ( e . g . asymmetrically elastic ) flexible extension member ; upon application of force to the flexible extension member , the member is guided or directed to bend towards a particular side or angle to facilitate displacement of the needle tip towards the main needle body . in an example , the flexible extension member comprises two different materials of different stiffness . when normal suturing function is desired as with a conventionally contiguous needle , for the present break - away needle the mechanism of activation can tightly secure the needle tip to the needle body so that a force exerted upon the needle during tissue penetration will not substantially disturb the ability of the needle tip to maintain a position of alignment and / or connection with respect to the needle body . fig8 d illustrates the needle assembly with flexible extension and shows multiple device states with the break - away property . for example , the break - away needle tip hangs or leans towards one side of the needle body such as location 8 h . fig8 g illustrates that flexible extension 8 j can have a segment or end 8 k that allows connection of flexible extension 8 j with the main general extension . the connecting segment 8 k and corresponding connections of the flexible extension to the needle body / main extension and to the needle point 8 l can be constructed using techniques known in the art , and likewise for the connection between needle point 8 l and the flexible member extension 8 i . it is noted that for clarification of terminology , the needle assembly can be activated to assume a disarmed state which might be considered an inactivated state ; conversely , depending on preset conditions the needle can be activated to assume an armed state . activation can optionally be reversible or one - way . fig1 illustrates various materials and methods including parts for construction of embodiments of the present invention and variations . construction is not necessarily limited to the disclosed parts specifically . the various fig1 are intended to generally and in certain instances specifically provide information on embodiments , e . g . information on the mechanism of activation , structural properties and characteristics for certain functions , and materials . fig1 illustrates a shape memory alloy material as element 10 a . in an embodiment the sma can be nitinol or another alloy with similar properties , and various formulations thereof as disclosed herein and / or known to the art , and is preferably nitinol . if the nitinol assembly is to achieve the desired contraction effect by ohmic heating , in an embodiment the assembly must have a positive and negative terminal end for the conduction of the electrical current and be electrically insulated in various aspects by traditional means . the transmission of the electrical current can be achieve through various means but is generally represented by the fig1 f such as with a conducting wire . a spring assembly itself , however , could act as a conductor . other possibilities include that the nitinol could be filled with a conductive matrix ; the wire could be routed through the nitinol ( such as through a nitinol tube ) l ; or the distal end of a slider point attached to the nitinol could make contact with the positive side of the needle and the negative side . moreover , any combination of the needle body and or the above parts or others can achieve the proper conduction of energy to the sma material to allow function . in an embodiment of a suture needle and needle holder combination , the contact points for electrical conduction ultimately are routed to the needle holder so that the property of ohmic heating can be exhibited . therefore , a member / point 10 b ( fig1 ) is placed in contact with an external contact point or surface of the needle body , and a corresponding member / point 10 d is placed towards an opposite end of said sma component 10 a to complete a path . for simplicity of design and in part due to size constraints , a preferred embodiment minimizes the necessary parts such as for electrical operation . the main body construction is formed so as to give separate conduction areas , namely positive and negative sides ( optionally referred to as plates ; these can be separate pieces of the needle body ). in an embodiment , a spring form 10 c or variation thereof is constructed and retained so as to provide a sufficient exerting force ( rebound tension ) so as to extend the sma material after contraction ; the exerting force is also able to be overcome by the contraction of the sma material . in another embodiment , a spring 10 h ( fig1 ) is used in the assembly to achieve a singular permanent ( one time ) activation for the sharp tip resting point mechanism . upon activation of the needle assembly , the linear projection of a sheath / blunting mechanism is extended ; a retraction spring contracts or compresses the mechanism so as to allow the resting point to arrive at its desired location , and provide a snug fit . a main extension shaft 10 e is connected to a sheathing / blunting sub - assembly and connected to a distal contact point of the sma sub - assembly or to a slider or translocation means that can freely move within a compartment of a needle body cannula 1 c ( the slider / translocation means can optionally act as one of the conduction points in relation to moving within the needle assembly and making contact with the main needle body conduction parts ). in embodiments , variations of the one time use feature can pertain to the property of nitinol to contract when heated . fig1 . 1 a ( includes fig1 . 1 aa , fig1 . 1 ab , fig1 . 1 ac , and fig1 . 1 ad ) illustrates an activator or activation mechanism . the activator comprises an sma wire , sheet , or filament 10 a , a crossbar 10 . 1 ae of bendable material that is either part of or separate to an extendable retention plate 10 . 1 ag which can act as a retaining device for an extension spring 10 . 1 a . the crossbar assembly and retention plate form a unit that retain the spring from extending . the sma wire is positioned such as in a loop over the crossbar . upon contraction of the sma wire , the sma wire pulls the crossbar down or causes the crossbar to break free from at least one of one or more contact points 10 . 1 af with the slider 10 . 1 ag , thereby pulling the crossbar 10 . 1 ae down through an opening in the slider 10 . 1 ah and releasing the tension of the spring 10 . 1 ai which in turn is driven to extend linearly the extension plate 10 . 1 be which is operatively connected to the sheathing mechanism . fig1 . 1 b and fig1 . 1 c illustrate similar mechanisms ( comprised of parts illustrated in fig1 . 1 d and fig1 . 1 e ) that can be under tension . in these embodiments , the sma / nitinol component is attached to the slider plate by a crimp , or crimp fastening means ( e . g . element 10 . 1 bd in fig1 b a etc .) and thereby secured . fig1 . 1 c ( including fig1 . 1 ca , fig1 . 1 cb , and fig1 . 1 cc ) illustrate other variations of an activator having an under - tension mechanism . in these embodiments in these embodiments , the sma / nitinol component is attached to the slider plate by an adhesive such as glue , a weld , or fastening means to extension plate 10 . 1 cd , where a bond strength is sufficient to retain the spring yet fails or breaks upon contraction of the sma component . fig1 . 1 d ( including fig1 . 1 da , fig1 . 1 db , fig1 . 1 dc , and fig1 . 1 dd ) illustrate further variations of an activator having an under - tension mechanism . in these embodiments , the sma / nitinol mechanism involves a slider plate with a groove 10 . 1 dg . the sma component 10 a can extend through slider plate groove 10 . 1 dg , and the sma 10 a has an attached retention point 10 . 1 de permitting sma 10 a to rest firmly in slot 10 . df . when the sma 10 a contracts , it detaches or “ pops ” the retention point from the resting spot and slips the retention point 10 . 1 de through the corresponding groove 10 . 1 dg within the slider plate , thereby releasing the plate which is under tension form the spring 10 . 1 di which extends the slider plate . the slider plate is ultimately connected to the extension or sheathing / blunting assembly . fig1 . 1 e ( including fig1 . 1 ea and fig1 . 1 eb ) illustrate a further variation . in this variation , a bend in the sma component 10 a acts as a retaining area of the activation mechanism which is holding an extension spring under tension . upon contraction , the sma component releases the spring , thereby linearly extending or projecting the sheathing mechanism . fig1 . 1 f ( including fig1 . 1 fa , fig1 . 1 fb , and fig1 . 1 fc ) illustrate other variations of an activator under tension . in these variations there is an sma plate 10 . 1 fe that is preformed in a bent configuration with an aperture / hole that is deformed 10 . 1 ff when the activator is in a bended state so as to retain an extension shaft with a retaining point 10 . 1 fg . the retaining point 10 . 1 fg is unable to slide through the aperture / hole 10 . 1 ff until the sma plate 10 . 1 fe is contracted . contraction allows the opening up of the joint 10 . 1 ff which allows the retaining point 10 . 1 fg to slide through , thereby releasing the tension bound spring which is connected to the linear extension assembly . in an embodiment , there can be a relatively simple device and design allowing elimination of many small and intricately engineered parts . the device can incorporate the function of one time activation , pertaining to the linear extension of a deformed nitinol wire that is activated by an external means . as disclosed herein , however , many activation mechanisms can be applied . the present inventor believes that the most efficient manifestation may require a lone deformed sma shaped component which would achieve a net extension in a linear dimension and thereby extend or project a sheathing mechanism or be unitary in serving as an activating / extending and sheathing mechanism . fig1 i , fig1 j , fig1 k , and fig1 l illustrate the general orientations of the assemblies of activation in relation to the external needle body parts and certain attachments , connections , or fixations of the elements without necessarily being limiting to certain areas or sequences of placement of parts or general assembly in manufacturing . the various figures in the set of fig1 ( e . g . fig1 , fig1 a , fig1 a a , fig1 b , fig1 c , fig1 c a , fig1 d , fig1 e , fig1 e a , fig1 g , fig1 f , fig1 h , fig1 i , fig1 j , fig1 k , fig1 l , fig1 m ) illustrate the various assembly and construction of the needle body for purposes relating to embodiments of the invention , for example , for the needle body to conduct electricity , be structurally sound , and be able to retain device components or mechanisms ( some of which are internally disposed in said needle body assembly ) such as an activator assembly , extension shaft assembly , and sheath assembly . it is recognized that the construction and manufacturing relating to devices and methods of the present invention can accommodate adaptations and modifications as disclosed herein and as would be understood from the disclosure herein by techniques and knowledge available to one of ordinary skill in the art . fig1 illustrates a general suture needle in a conventionally curved form . the exterior main needle body can be manufactured according to techniques as known in the art . in an embodiment the main needle body and its accessories are formed separately form a top conduction plate 11 n and a bottom conduction plate 11 o , wherein the top and bottom conduction plates are affixed to a top needle body outer surface and bottom needle body outer surface respectively . the needle body is further formed so as to retain two proximal side portions 11 p and 11 q that can each run laterally about half the length of the needle . in variations , the conductive aspect such as the side portions can extend along the needle body from about 5 % to about 95 % of the length of the needle body so as to allow a variety of locations for grasping by a holder or for transferring energy . the needle body can have a needle body core section removed , leaving two side walls 11 p and 11 q in order to make space available for the conduction plates and provide attachment surfaces or areas for joining of the conduction plates to the needle body . the side panels and the conduction plates are joined using known means such as adhesive , crimping , welding , devices and methods shown in fig1 m or fig1 h , or means of fastening ( alternatively , a needle body instrument is initially molded or forged to have desired capabilities ) and are insulated as understood in the art , for example with current technology such as teflon or plastic coating or standard means . the preceding parts together form an exterior needle body as a whole thereby generating an internal compartment or hollow cannula 1 d . on a conduction plate there can be a conducting surface to allow conduction of electricity and contact with a means for supplying electricity or to serve as an attachment abutment for connection to a suture material 11 r . these separate parts are made and connected so as to provide a proper conduction pathway to transmit the necessary electrical current or so as to act as a retainer for an internal sub - assembly such as an activation mechanism . fig1 a , and fig1 a a illustrate views of assembly of the needle body . fig1 b illustrates a main needle body design having only a top conduction plate to serve as an electrical terminal end as the main needle body can act itself like a conduction plate itself as a second terminal end of a circuit . fig1 c and 11 ca describe views of such an assembly . fig1 d illustrates a main needle body comprising three separate pieces ; a top plate 11 n , a bottom plate 11 o , and the main needle distal needle body 1 c . the pieces are connected to form a whole such as by connecting the top and bottom plate with fastening means to form a top and bottom plate combination and connecting the combination to the body 1 c using the same or different fastening means . optionally the needle body 1 c can be configured to allow partial overlap such as by comprising a half - cylinder segment receptive for either a top plate or bottom plate . fig1 e and 11 ea illustrate and describe views of this concept . fig1 g illustrates a simple manifestation of a needle body using construction of only one piece . such a needle body can be sufficient to accept some sub - assemblies such as certain mechanisms of activation . this design can be suitable for certain one time use activation mechanism involving stylizing the shape characteristic of an sma component . fig1 f shows a two piece design of a top plate that runs along the length of the needle body and a bottom plate which fully corresponds to the top plate . the joining of various parts can be accomplished for example with various means , including adhesives , crimps , welds , and also the utilization of new means according to this context . fig1 l gives a close up , of ridges , teeth , or frictional grasping means 11 v that can be disposed along the an interior side of each of the top and bottom plates in order to give a grasping surface to retain a suture material . fig1 i shows a close up cutaway view of this potion of the needle in relation to the bottom and top plates , the conduction and attachment point 11 r , and other pieces . fig1 h illustrates utilization of an annular or partial ring - like fixture to secure or encompass the relevant parts of the needle assembly . such a fixture can retain all of the pieces as one , for example by crimping the annular fixture 11 t or by other fastening means , such as gluing , welding , etc . the corresponding portions 11 u of the needle body parts are optionally manufactured to accompany the rings so as to minimize the providing of a surface allowing snagging , drag , or other unwanted effect . fig1 j illustrates a needle assembly end that has suture material in place with the described parts . fig1 m illustrates channeling and notching of the corresponding portions of the needle body as a way to connect / assemble the parts . fig1 k illustrates crimping of a proximal end of the needle that is typically used for retention of suture material . regarding certain needle body parts , e . g . the needle main body , conducting plates , annular fixture , etc . a variety of conventional materials can be used as known in the art such as steel , stainless steel , and / or polycarbonate among others . needles of the invention are used in conjunction with a needle holder . fig2 ( prior art ) shows a front view of a general widely used needle holder of any size . fig2 a and 2b ( not prior art ) illustrate opposite sides of a modified needle holder with a holder initiation assembly for attachment that carries out the function of initiating activation of the suture needle assembly by the application of heat or electricity . the holder initiation assembly for attachment to an existing needle holder is further illustrated in fig2 c , fig2 d , and fig2 e . the holder initiation assembly has a vertical top portion 2 p and a vertically corresponding bottom portion 2 q . the 2 p and 2 q portions come together in an aligned fashion ( see fig2 f , fig2 g , and fig2 h ). this holder initiation assembly mechanism is designed so as to fit a variety of sizes of needle holders by utilizing attachment securing points 2 y ( see fig2 c , fig2 e ) which can fit over the corresponding portion of a needle holder . the holder initiation assembly portions 2 p and 2 q can join together with an adjustably tightening ratcheting mechanism 2 x comprising an upper portion 2 z ( connected to 2 p ) that is notched for accepting the corresponding screw mechanism 2 aa that is fixated within 2 q . the assembly ratchets together as illustrated by sequential portrayal of fig2 f , fig2 g , and fig2 h , by the tightening of the fixed assembly 2 aa which has a shaft that is adjustable by the insertion of a standard or alan wrench . other adjustable and nonadjustable connecting means can be used for adjoining 2 p with 2 q such as clip - locks and other fastening means . the tip segment 2 r of the 2 p portion can be hollow in nature so as to allow the insertion of the corresponding needle holder tip sequence ( fig2 j , fig2 k , fig2 l ) shown in fig2 i . the holder initiation assembly locks on to a conventionally existing needle holder by tightening the ratcheting mechanism and is adaptable to different sized needle holders . the secondary tip appendage 2 r can also be hollow in nature and fit over the second needle tip holder portion or “ jaw ” sequence shown in fig2 i ( including fig2 j , fig2 k , and fig2 l showing an ordered sequence of events ). this tip appendage is retained by a screw mechanism 2 m ( element 2 m as opposed to fig2 m ) that can be secured onto the second needle holder tip 2 bb or screw directly into a receiving cavity or hole 2 o that is disposed within the needle holder tip 2 bb . the secondary tip of the said assembly is connected to the main upper body of the assembly 2 p by a small wire 2 u or means for allowing insulated transmission of electrical current to the conductive surface 2 v . as an overview explanation , the holder initiation assembly attachment has two attachment contact tips . a first attachment contact tip is element 2 r , and a second attachment contact tip is a tip portion of element 2 p . these two attachment contact tips fit over the needle holder tips 2 w and 2 bb ( or insertionally receive 2 w and 2 bb ) and provide conductive surface 2 v for the transmission of electricity to the needle body or have internally located heating elements 2 . 2 that provide heat for initiation of the needle body mechanism of activation . the needle holder initiation attachment can have an internal power supply 2 u and an optionally simple internal circuit and circuitry ( not shown ). both the power supply and the circuit ( not shown ) can be located apart from the needle holder unit ( see fig2 . 2 c ) and be located at a fixed point in a different power supply unit 2 . 2 d with controls 2 . 2 e , a cord 2 . 2 g that connects to the needle holder , and an attachment plug 2 . 2 f , that corresponds to the cord . the circuit is established as understood in the art by optionally a simple circuit of the pulse width modulation variety or other variety so as to control the nominal amount of voltage or current required . the circuit and controls are preferably adapted to prevent the overheating or malfunction of the assembly of activation . the circuit can have a regulatory mechanism , for example a control switch or button 2 s , or means for circuit regulation that can optionally be ergonomically located to allow easy regulation by the operator in order to initiate the mechanism of activation ultimately residing in the needle . in a particular example , the needle holder initiation attachment is of unitary construction and fulfills all necessary characteristics by incorporating the needed assemblies into one needle holder mechanism ( see fig2 . 1 and fig2 . 1 a ). further devices and methods for initiation of activation include but are not limited to the following : a container of warm water , saline , or other fluid ( fig2 . 2 b ), a hot plate ( fig2 . 2 a ) with an internal or external power supply ( not shown ), circuit ( not shown ), and heating element ( not shown ). in fig2 . 3 a and fig2 . 4 b , a needle holder variation is shown . in this variation , an operator can normally insert a thumb and finger ( such as a forefinger ) through the holes of the needle holder . at or near a point where the opposing fingers ( such as thumb and finger ) tend to naturally come together , a switch is placed . this switch can optionally have two segments or halves and be activated by a clamping of the needle holder . various combinations of configurations of the above assemblies used in conjunction with the mechanism of action of the needle itself can be used . disclosed is a needle featuring a unifying element . the unifying element can provide reinforcement in the presence of adversely stressful forces that may otherwise result in cracking or dissociation of a part of the needle from another part or the remainder of the needle body . in a needle of the invention , an sma component can be integrated to function as a relatively pliable shaft that is optionally placed centrally but nonetheless disposed along a portion or the entire length of a longitudinal axis of the needle . in case of accidental breakage , the shaft holds at least one or more broken pieces of the needle body together so as to not allow the broken pieces to fall , lodge , or be lost within a body tissue . kit forms of the invention are provided . a safety suture kit comprises a needle of the invention and suture material . another kit comprises a needle and needle holder of the invention and suture material . another kit comprises a needle , modified needle holder , and suture material . all references throughout this application , for example patent documents including issued or granted patents or equivalents ; patent application publications ; and non - patent literature documents or other source material ; are hereby incorporated by reference herein in their entireties , as though individually incorporated by reference , to the extent each reference is at least partially not inconsistent with the disclosure in this application ( for example , a reference that is partially inconsistent is incorporated by reference except for the partially inconsistent portion of the reference ). any appendix or appendices hereto are incorporated by reference as part of the specification and / or drawings . where the terms “ comprise ”, “ comprises ”, “ comprised ”, or “ comprising ” are used herein , they are to be interpreted as specifying the presence of the stated features , integers , steps , or components referred to , but not to preclude the presence or addition of one or more other feature , integer , step , component , or group thereof . the invention has been described with reference to various specific and preferred embodiments and techniques . however , it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention . it will be apparent to one of ordinary skill in the art that compositions , methods , devices , device elements , materials , procedures and techniques other than those specifically described herein can be applied to the practice of the invention as broadly disclosed herein without resort to undue experimentation . all art - known functional equivalents of compositions , methods , devices , device elements , materials , procedures and techniques described herein are intended to be encompassed by this invention . whenever a range is disclosed , all subranges and individual values are intended to be encompassed . this invention is not to be limited by the embodiments disclosed , including any shown in the drawings or exemplified in the specification , which are given by way of example or illustration and not of limitation . u . s . pat . nos . 5 , 437 , 681 ; 5 , 540 , 705 ; 5 , 728 , 108 ; 6 , 832 , 478 by anderson , et al . issued dec . 21 , 2004 ; u . s . pat . no . 5 , 947 , 983 by solar , et al . issued sep . 7 , 1999 ; 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