Abstract:
A forceps comprises a reusable portion and a disposable portion configured to operably engage the reusable portion, the disposable portion including at least one limited-use feature, wherein upon disengagement of the disposable portion from the reusable portion, the at least one limited-use feature is transitioned from a first state, permitting engagement of the disposable portion with the reusable portion, to a second state, wherein the limited-use feature inhibits reengagement of the disposable portion with the reusable portion.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/866,837, filed on Aug. 16, 2013, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to medical devices. More particularly, the present disclosure is directed to limited-use medical devices and medical devices including limited-use features. 
         [0004]    2. Background of the Related Art 
         [0005]    Certain medical devices (or components thereof) are capable of being used multiple times, and are thus referred to as reusable devices (or reusable components), while other medical devices (or components thereof) are configured for single use, and are thus referred to as disposable devices (or disposable components). Many such reusable and disposable medical devices, and/or the components thereof, are designed for a pre-determined number of uses and/or for a pre-determined usage time. Use of these devices beyond their prescribed usage time or number of uses may result in failure of the device, damage to the device, and/or injury to the patient or clinician. On the other hand, given the rising costs of performing medical procedures, clinician&#39;s have an incentive to maximize the reuse of medical devices (or components thereof). 
       SUMMARY 
       [0006]    Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus that is closer to the user and the term “distal” refers to the end of the apparatus that is farther away from the user. The term “clinician” refers to any medical professional (e.g., doctor, surgeon, nurse, or the like) performing a medical procedure. The term “reusable” means that a device is capable of being used more than once. The term “sterilizable” means that a device is capable of being cleaned using a suitable procedure. To the extent consistent, any of the aspects and features described herein may be used in conjunction with any or all of the other aspects and features described herein. 
         [0007]    In at least one aspect of the present disclosure, a forceps includes a reusable portion and a disposable portion configured to operably engage the reusable portion, the disposable portion including at least one limited-use feature, wherein upon disengagement of the disposable portion from the reusable portion, the at least one limited-use feature is transitioned from a first state, permitting engagement of the disposable portion with the reusable portion, to a second state, wherein the limited-use feature inhibits reengagement of the disposable portion with the reusable portion. 
         [0008]    In another aspect of the present disclosure, the disposable portion is a disposable electrode assembly. 
         [0009]    In another aspect of the present disclosure, the disposable electrode assembly is configured to conduct electrosurgical energy to tissue. 
         [0010]    In another aspect of the present disclosure, the reusable portion is a jaw member disposed at a distal end of the forceps, the disposable portion is a jaw substrate that is operably engagable with the jaw member, and wherein the limited-use feature is a bifurcated anchor member disposed on the jaw substrate, the bifurcated anchor member being disposed in the first state before insertion into the jaw member, maintained in the first state after insertion into the jaw member, and transitioned to the second state upon disengagement from the jaw member. 
         [0011]    In another aspect of the present disclosure, the bifurcated anchor member is made from a material having a low material failure such that removal of the bifurcated anchor member breaks at least a portion of the bifurcated anchor member, thus rendering the bifurcated anchor member inoperable for reinsertion into the jaw member. 
         [0012]    In another aspect of the present disclosure, the reusable portion is a shaft member of the forceps and the disposable portion is a housing, and wherein the limited-use feature is a frangible anchor member that facilitates attachment of the housing to the shaft member. 
         [0013]    In another aspect of the present disclosure, transition of the limited-use feature from the first state to the second state renders the disposable portion electrically inoperable. 
         [0014]    In another aspect of the present disclosure, the disposable portion is configured to be disengaged from the reusable portion via a release member, wherein actuation of the release member transitions the limited-use feature from the first state to the second state. 
         [0015]    In another aspect of the present disclosure, the limited-use feature further includes at least one mechanical fuse, and wherein, in the second state, the mechanical fuse prevents electrosurgical energy from being applied to tissue. 
         [0016]    In another aspect of the present disclosure, the at least one mechanical fuse is configured to disconnect or break upon removal of the disposable portion from the reusable portion. 
         [0017]    In another aspect of the present disclosure, a method for preventing reuse of a surgical instrument includes the steps of providing a forceps including a reusable portion and a disposable portion configured to operably engage the reusable portion, the disposable portion including at least one limited-use feature, wherein upon disengagement of the disposable portion from the reusable portion, the at least one limited-use feature is transitioned from a first state, permitting engagement of the disposable portion with the reusable portion, to a second state, wherein the limited-use feature inhibits reengagement of the disposable portion with the reusable portion, and disengaging the disposable portion from the reusable portion, thereby transitioning the limited-use feature from the first state to the second state. 
         [0018]    In another aspect of the present disclosure, a forceps includes a reusable portion and a disposable portion configured to operably engage the reusable portion, the disposable portion including at least one limited-use feature, wherein upon disengagement of the disposable portion from the reusable portion, the at least one limited-use feature is transitioned from a first state, permitting engagement of the disposable portion with the reusable portion, to a second state, wherein the limited-use feature inhibits reengagement of the disposable portion with the reusable portion, wherein the limited-use feature includes a flexible clip configured to anchor the disposable portion to the reusable portion. 
         [0019]    In another aspect of the present disclosure, the reusable portion includes a channel for accepting the flexible clip to allow the disposable portion and the reusable portion to snap-fit into engagement. 
         [0020]    In another aspect of the present disclosure, the flexible clip is prevented from being removed from the channel without fracturing the flexible clip by applying a suitable force to fracture the flexible clip. 
         [0021]    In another aspect of the present disclosure, the flexible clip is made of a brittle, crumplable, stretchable, or deformable material that allows disengagement under a desired force, but permanently disables flexible clip from reuse. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings, wherein: 
           [0023]      FIG. 1  is a perspective view of a forceps provided in accordance with the present disclosure including a mechanical forceps, a disposable housing, and a disposable electrode assembly; 
           [0024]      FIG. 2  is an enlarged, perspective view of a distal end of the forceps of  FIG. 1 ; 
           [0025]      FIG. 3  is a perspective view of the forceps of  FIG. 1  with parts separated; 
           [0026]      FIG. 4  is an enlarged, internal, side view of the disposable housing and the disposable electrode assembly of the forceps of  FIG. 1 , with parts partially removed; 
           [0027]      FIG. 5  is a greatly-enlarged, perspective view of the disposable electrode assembly of the forceps of  FIG. 1 ; 
           [0028]      FIG. 6  is a greatly-enlarged, perspective view of one of the electrodes of the disposable electrode assembly of  FIG. 1  with parts separated; 
           [0029]      FIG. 7  is a greatly-enlarged, perspective view of the other electrode of the disposable electrode assembly of  FIG. 1  with parts separated; 
           [0030]      FIG. 8  is a side, perspective view of the forceps of  FIG. 1  grasping tissue; 
           [0031]      FIG. 9A  is an enlarged, internal, perspective view of another embodiment of a disposable housing and disposable electrode assembly provided in accordance with the present disclosure, with parts partially removed, shown engaged with a forceps; 
           [0032]      FIG. 9B  is an enlarged, internal, perspective view of the disposable housing and disposable electrode assembly of  FIG. 9 , shown after disengagement from a forceps; 
           [0033]      FIG. 10A  is an enlarged, cross-sectional view of another electrode assembly, shown separated from a jaw member; 
           [0034]      FIG. 10B  is an enlarged, cross-sectional view of the electrode assembly of  FIG. 10A , shown engaged to the jaw member; 
           [0035]      FIG. 10C  is an enlarged, cross-sectional view of the electrode assembly of  FIG. 10A , shown after disengagement from the jaw member; 
           [0036]      FIG. 11A  is an exploded, perspective view of a release mechanism provided in accordance with the present disclosure and configured for use with a forceps similar to the forceps of  FIG. 1 ; 
           [0037]      FIG. 11B  is an enlarged, top, cross-sectional view of the release mechanism of  FIG. 11A , shown disengaged from the forceps; 
           [0038]      FIG. 12A  is a top, perspective view of a housing half provided in accordance with the present disclosure and configured for use with a forceps similar to the forceps of  FIG. 1 , the housing half including an anchor member; and 
           [0039]      FIGS. 12B-12D  are side, cross-sectional views of the housing half and anchor member of  FIG. 12A , illustrating attachment and detachment of the housing half to the forceps. 
       
    
    
     DETAILED DESCRIPTION 
       [0040]    Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. 
         [0041]    Referring now to  FIG. 1 , a forceps  10  for use in connection with open surgical procedures is shown, although forceps  10  may also be configured for use in connection with endoscopic surgical procedures. Alternatively, the present disclosure may be embodied in any other suitable medical devices such as, but not limited to scissors, staplers, probes, syringes, and any other electrical, mechanical, or electromechanical medical devices. 
         [0042]    Disclosed herein are embodiments of a medical device having one or more removable components including at least one limited-use feature configured to limited use or reuse of the forceps. The present disclosure is described hereinbelow, by way of example only, with respect to a bipolar forceps  10  including a reusable portion  20  having an end effector  24  disposed at a distal end thereof and a disposable portion  500  including a disposable housing  70  and a disposable electrode assembly  21 . 
         [0043]    Continuing with reference to  FIG. 1 , reusable portion  20  includes first and second elongated shaft members  12  and  14 . Elongated shaft member  12  includes proximal and distal end portions  13  and  17 , respectively, and elongated shaft member  14  includes proximal and distal end portions  15  and  19 , respectively. Disposed at proximal end portions  13 ,  15  of shaft members  12 ,  14  are handle members  16  and  18 , respectively, that are configured to allow a user to effect movement of at least one of the shaft members  12  and  14  relative to the other. The end effector  24  includes opposing jaw members  42 ,  44  that extend from the distal end portions  17  and  19  of shaft members  12  and  14 , respectively. The jaw members  42 ,  44  are movable relative to each other in response to movement of shaft members  12 ,  14 . 
         [0044]    Shaft members  12  and  14  are affixed to one another about a pivot  25  such that movement of shaft members  12 ,  14 , imparts movement of the jaw members  42 ,  44  from an open configuration ( FIG. 1 ) wherein the jaw members  44 ,  42  are disposed in spaced relation relative to one another to a clamping or closed configuration ( FIG. 8 ) wherein the jaw members  42 ,  44  cooperate to grasp tissue  150  therebetween. 
         [0045]    Each shaft member  12  and  14  also includes a ratchet portion  32  and  34  that extends from the proximal end portion  13 ,  15  of the respective shaft member  12 ,  14  towards the other ratchet in a generally vertically aligned manner such that the inner facing surfaces of each ratchet  32  and  34  abut one another when the shaft members  12 ,  14  are approximated. Each ratchet  32  and  34  includes a plurality of flanges  31  and  33  ( FIG. 3 ), respectively, that project from the inner facing surface of each ratchet  32  and  34  such that the ratchets  32  and  34  may interlock at one or more positions. In some embodiments, each ratchet position holds a particular strain energy in the shaft members  12  and  14  to impart a specific closure force to the end effector  24 . At least one of the shaft members, e.g., shaft member  12 , includes a tang  99  that facilitates manipulation of forceps  10  during surgical conditions as well as facilitates attachment of electrode assembly  21  on reusable portion  20  as will be described in greater detail below. 
         [0046]    Referring to  FIGS. 2 and 3 , in conjunction with  FIG. 1 , disposable portion  500  includes a housing  70  and a disposable electrode assembly  21  that are configured to releasably couple to reusable portion  20 . Housing  70  includes a pair of housing halves  70   a ,  70   b  configured to matingly engage and releasably encompass at least a portion of one of the shaft members, e.g. shaft member  14 . As discussed in more detail hereinbelow, disposable portion  500  includes one or more limited-use features to prevent re-use thereof. 
         [0047]    Continuing with reference to  FIGS. 2 and 3 , housing  70  may also serve to house other features of the forceps  10  which are not discussed in detail herein, e.g, knife  85  and knife actuation mechanism  90  configured to effect advancement of the knife  85  through a knife channel  58  ( FIG. 2 ) defined in one or both electrodes  110 ,  120  to transect sealed tissue. Alternatively, a cutting electrode (not shown) may be provided on one of jaw members  42 ,  44  for electrically cutting tissue. 
         [0048]    Referring to  FIGS. 3-4 , an interior of each of housing half  70   a ,  70   b  may include a plurality of cooperating mechanical interfaces  501  disposed at various positions to effect mechanical coupling of housing halves  70   a ,  70   b  to form housing  70  about shaft  14 . It is important to note that housing  70  and the inter-cooperating components therein e.g., knife  85 , knife actuator  90 , limited use features (as described herein), are all pre-assembled and the entire housing  70  is designed to snap-fit (or otherwise engage) shaft  14 . This facilitates assembly of the disposable portion  500  with the reusable portion  20 . 
         [0049]    It is important to note that in other embodiments, as described in more detail below, the limited-use feature of disposable portion  500  includes frangible mechanical interfaces  501  or similar anchor portions that are configured such that disengagement of housing halves  70   a ,  70   b , e.g., to disengage housing  70  from shaft member  14 , requires permanently breaking one or more of the mechanical interfaces  501 . As such, upon disassembly, housing halves  70   a ,  70   b  are no longer engagable with one another, thereby inhibiting reuse of housing  70 . In this instance, more assembly of the disposable portion  500  would be required. Mechanical interfaces  501  may be created using brittle materials such that pulling apart the housing halves  70   a ,  70   b  fractures the material forming mechanical interfaces  501 . In other embodiments, any suitable structure(s) or mechanism(s) for causing mechanical interfaces  501  to fail upon disassembly, e.g., upon disengaging halves  70   a ,  70   b  from one another, may be employed. 
         [0050]    As shown in  FIGS. 4-5 , a pair of wires  61  and  62  are electrically connected to the electrodes  120  and  110 , respectively, and are bundled to form a cable  28  that extends through housing  70  and terminates at a terminal connector  30  ( FIG. 1 ) configured to mechanically and electrically couple to a suitable energy source such as an electrosurgical generator (not shown). The limited-use feature of the disposable portion  500  may include wires  61 ,  62  and/or cable  28 , such that disengaging disposable portion  500  from the forceps  10  causes the wires  61 ,  62  and/or cable  28  to sever or otherwise become electrically interrupted. For example, with further reference to  FIGS. 9A and 9B , a release button  503  provided for disengaging disposable portion  500  from reusable portion  20  may include a blade  505  for severing cable  28  upon disengagement of disposable portion  500  from reusable portion  20 . After use, a user would press release button  503  to remove disposable portion  500  from reusable portion  20 , and in doing so, would sever cable  28 , thereby requiring replacement of disposable portion  500 . Mechanical fuses may be used in place of or in conjunction with the wire cutting mechanism shown in  FIGS. 9A and 9B , such that the release button  503  breaks a mechanical fuse at a desired location (e.g., at the joint of prong-like portions  103 ,  105  described below) along the line of electrical conductivity. 
         [0051]    Referring now to  FIGS. 3-7 , electrode assembly  21  includes a generally circular boss member  49  configured to be seated (e.g., friction fit) within a complementary aperture  71  disposed through a distal end of housing half  70   a  to releasably attach electrode assembly  21  thereto. Electrode assembly  21  is bifurcated such that two prong-like members  103  and  105  extend distally therefrom to support electrodes  110  and  120 , respectively. Prong-like members  103 ,  105  may be flexibly connected at a living hinge or rotatably connected in any other suitable manner. 
         [0052]    Prong-like members  103  and  105  may be at least a portion of the limited-use feature of disposable portion  500 . For example, as shown in  FIG. 5 , prong like members  103 ,  105  may be configured to break apart from the electrode assembly  21  during disengagement of electrode assembly  21  from reusable portion  20 . More specifically, prong-like members  103 ,  105  may be at least partially made of a brittle material, or include a brittle portion  103   a ,  105   a , such that the forces required to disengage electrode assembly  21  from housing  70  are sufficient to fracture the brittle material or portion  103   a ,  105   a . Alternatively, portions  103   a ,  105   a  (or the entire prong-like members  103 ,  105 ) may be configured to crumple or otherwise deform upon disengagement. Any other suitable structure(s) or mechanism(s) for breaking or deforming prong-like members  103 ,  105  during disengagement may additionally or alternatively be employed. 
         [0053]    Electrode  120  includes an electrically conductive sealing surface  126  configured to conduct electrosurgical energy therethrough and an electrically insulative substrate  121  that serves to electrically insulate jaw member  42  from sealing surface  126 . As shown in  FIG. 6 , and similar to prong-like members  103 ,  105  described above, the limited-use feature of disposable portion  500  may include at least a portion of the sealing surface  126  and/or substrate  121  such that the sealing surface  126  and/or substrate  121  breaks, is disfigured or is otherwise rendered inoperable upon disengagement from reusable portion  20 . Electrode  110  may include any or all of the features of electrode  120 . Thus, for purposes of brevity and avoiding repetition, similar features of electrodes  110 ,  120  will be described only once (with either collective reference to electrodes  110 ,  120  or the particular components thereof or with reference to only one of electrodes  110 ,  120  or the particular components thereof). 
         [0054]    Substrate  121  of electrode  120  includes a plurality of bifurcated anchor members  122  extending therefrom that are configured to compress during insertion into a corresponding plurality of sockets  43  disposed at least partially through jaw member  42  and subsequently expand to releasably engage corresponding sockets  43  after insertion to couple electrode  120  to jaw member  42 . Bifurcated anchor members  122  may be made of any suitable material having a low material failure stress such that removal of the bifurcated anchor members  122  breaks at least a portion of the bifurcated anchor members  122 , thus rendering the bifurcated anchor members  122  inoperable for reinsertion into the jaw member  42 . 
         [0055]    The limited-use feature of the disposable portion  500  may include the anchor members  122 . For example, and with additional reference to  FIGS. 10A-10C , anchor members  122  are configured to easily engage within sockets  43  ( FIGS. 10A and 10B ), but are inhibited from being disengaged from sockets  43  unless anchor members  122  are permanently snapped, broken, or otherwise disfigured ( FIG. 10C ). Anchor members  122  may be made of any suitable material and/or configuration such that a desired removal force may fracture or stretch bifurcated anchors  122  allowing substrate  121  to be disengaged from jaw member  42 , while rendering the anchors  122  thereafter unsuitable for engaging the substrate  121  about jaw member  42 . In other words, the anchor members  122  may be made of any suitable material and/or may be configured in any suitable fashion that allows anchors  122  to maintain engagement of the substrate  121  and the jaw member  42  during normal use, but upon disengagement the anchors  122  (and, thus, further use of substrate  121 ) are rendered inoperable. 
         [0056]    Referring again to  FIGS. 3-7 , conductive sealing surface  126  of electrode  120  includes a main body portion and an extension  135  having a wire crimp  117  configured to be inserted into the distal end  106  of prong  105  of electrode assembly  21  and electrically connect to wire  61  disposed therein ( FIG. 5 ). Sealing surface  116  includes similar features as sealing surface  126 . Sealing surfaces  116 ,  126  may be at least a part of the limited-use feature of disposable portion  500 . For example, as shown in  FIGS. 6 and 7 , sealing surface  116 ,  126  may include at least one crumble zone  507  comprised of a brittle material or a suitable material that allows for the respective sealing surface  116 ,  126  to crumble upon removal from jaw members  42 ,  44 . In other embodiments, conductive sealing surfaces  116 ,  126  may separate from substrates  111 ,  121  when removed from jaw members  42 ,  44  and may be configured such that sealing surfaces  116 ,  126  can no longer be engaged to respective substrates  111 ,  121 . Alternatively or additionally, substrates  111 , 121  may include crumple zones  507   a  for similar purposes. 
         [0057]    Referring to  FIGS. 11A-11B , a release pin  509  may be employed facilitate disengagement of housing  70  from shaft  14 . Upon depression of release pin  509 , housing  70  is urged apart from shaft  14  to disengage the mechanical snap or latch components retaining housing  70  to shaft  14 . Upon depression of release pin  509 , the release pin  509  is retained in the depressed position, e.g., via an O-ring  509   a  surrounding pin  509  and inhibiting return of pin  509 , such that housing  70  cannot be reengaged to shaft  14 , thereby preventing reuse of disposable portion  500 . 
         [0058]    As shown in  FIGS. 12A-12D , housing  70  includes a flexible clip  515  configured to anchor housing  70  and, thus, electrode assembly  21 , to the reusable portion  20 . Further, at least one shaft member  12 ,  14  ( FIG. 1 ), e.g., shaft member  14 , includes a channel  517  for accepting flexible clip  515  to allow housing  70  to snap-fit into engagement about shaft member  14  of reusable portion  20 . After insertion ( FIG. 12C ), the flexible clip  515  is prevented from being removed due to its shape and location in channel  517 . The only way to remove the flexible clip  515  (and thus housing  70 ) from the reusable portion  20  is to break flexible clip  515  by applying a suitable force to fracture flexible clip  515  ( FIG. 12D ). Flexible clip  515  may be made of any suitable brittle, crumplable, stretchable, or deformable material that allows disengagement under a desired force, but permanently disables flexible clip  515  from reuse. 
         [0059]    Referring again to  FIGS. 1-3 , to electrically control the end effector  24 , the housing  70  supports a pair of depressible activation buttons  50   a ,  50   b  that are operable by the user to actuate corresponding switches  60   a ,  60   b , (see  FIG. 3 ) respectively, disposed within housing  70 . Switches  60   a ,  60   b  are electrically interconnected with wires  61 ,  62 , respectively, and serve to initiate and terminate the delivery of electrosurgical energy from a suitable energy source to the end effector  24  to effect tissue treatment. Similar to the embodiments shown in  FIGS. 9A-9B , wires  61 ,  62  may be cut or linked to a mechanical fuse that is destroyed upon disengagement of disposable portion  500  from reusable portion  20 , thereby preventing further use of activation buttons  50   a ,  50   b.    
         [0060]    As described above, disposable portion  500  is configured for use with an electrosurgical forceps  10 , however, the principles disclosed herein regarding limited-use features, designs, and functionalities thereof may be applied to any other desired removable component of a medical device. 
         [0061]    It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawings are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.