Abstract:
A multiple use fluid dispenser dispenses a flowable material in a precise pattern and quantity with leaking and clogging between dispensing avoided by employing a trigger fired syringe plunger to expel a fixed volume through a band. Between strokes, an advancement knob rotates the band over a distal dispensing tip to a nondispensing location that wipes excess flowable material and seals a dispensing orifice in a fluid conduit. The advancement knob further may rotate the band to a dispensing position wherein a combination of one or more dispensing holes produce a desired pattern and rate of flow with material over the dispensing hole(s) serving to initiate the flowable material, to control placement, serve as a detachable bandage or buttress material, etc.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is related to commonly owned U.S. patent application Ser. No. 11/558,138, “SURGICAL MULTIPLE USE ADHESIVE APPLIER”, to Sheets et al., filed on even date herewith, the disclosure of which is hereby incorporated by reference in its entirety. 
     FIELD OF THE INVENTION 
     This invention relates to surgical dispensers of flowable material onto tissue with precise placement at a precise volume without leaking or clogging before or between uses for open and/or minimally invasive surgical procedures for purposes such as applying sealants, adhesives, drugs, schlerosing/necrosing agents, etc. 
     BACKGROUND OF THE INVENTION 
     Numerous swabs, applicators, dispensers and kits for dispensing and applying various materials, including adhesive materials, are known. However, these known arrangements possess various shortcomings that make them undesirable in many applications. 
     Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the X-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the .alpha.-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues. 
     Medical applications of 1,1-disubstituted ethylene monomer adhesive compositions include use as an alternative or an adjunct to surgical sutures and staples in wound closure as well as for covering and protecting tissue wounds such as lacerations, abrasions, burns, stomatitis, sores, and other open surface wounds. When such an adhesive is applied, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond. 
     Applicators for Dispensing a Polymerizable and/or Cross-Linkable Material, such as a 1,1-disubstituted Ethylene Formulation. 
     In general, many different 1,1-disubstituted ethylene formulations are known for various applications, for example, cyanoacrylate formulations used as fast-acting surgical adhesives, sealants, bioactive agent release matrixes and implants utilized in medical, surgical and other in vivo applications. 
     However, due to the need to apply the adhesive in its monomeric form, and due to the rapid polymerization rate of the monomers, it has been very difficult to design effective and commercially viable applicators and/or dispensers. Such applicators and/or dispensers must counterbalance the competing requirements that the monomer not prematurely polymerize, that the monomer be easily applied, that the monomer polymerize at a desired rate upon application, and that the sanitary and/or sterile properties of the monomer and applicator—whether real or perceived—be maintained. This latter requirement, that the actual or perceived sanitary and sterile condition of the monomer and applicator be maintained, is particularly important in medical applications, where the user and/or the patient desires a clean product so as not to introduce further bacteria or foreign matter into a wound site. 
     While such adhesives have very demanding properties (e.g., rapid polymerization) that impede desired dispensing, other liquids to varying degrees have similar limitations that would benefit from precise placement without clogging and leaking, especially for a device capable of multiple uses. Consequently, a significant need exists for an improved surgical fluid dispenser. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention. 
         FIG. 1  is a left side view in elevation of a multiple use fluid dispenser for surgical use. 
         FIG. 2  is a front left isometric view of the multiple use fluid dispenser of  FIG. 1 . 
         FIG. 3  is a front left exploded view of the multiple use fluid dispenser of  FIG. 1 . 
         FIG. 4  is a front left isometric view of the multiple use fluid dispenser of  FIG. 1  taken in vertical cross section along a longitudinal axis and with a portion of the elongate shaft omitted. 
         FIG. 5  is a front left isometric detail view of a distal applicator tip of the multiple use fluid dispenser of  FIG. 1 . 
         FIG. 6  is a left side view in vertical cross section taken through a longitudinal axis of the distal applicator tip of  FIG. 5 . 
         FIG. 7  is a left side view in elevation of the multiple use fluid dispenser of  FIG. 1  with a left housing half shell and a left portion of the shaft removed in an initial state with a trigger forward and a syringe plunger fully retracted aft. 
         FIG. 8  is a left side view in elevation of the multiple use fluid dispenser of  FIG. 1  with the left housing half shell and portions of the shaft removed during a first dispensing stroke of the trigger. 
         FIG. 9  is a left side view in elevation of the multiple use fluid dispenser of  FIG. 1  with the left housing half shell and portions of the shaft removed as the first dispensing stroke concludes and an anti-backup engages a plunger arm. 
         FIG. 10  is a left side view in elevation of the multiple use fluid dispenser of  FIG. 1  with the left housing half shell and portions of the shaft removed as the trigger is released and the anti-backup pawl maintains a position of the plunger arm. 
         FIG. 11  is a left side view in elevation of the multiple use fluid dispenser of  FIG. 1  with the left housing half shell and portions of the shaft removed as the trigger engages a second position of the plunger arm and an advancement knob is rotated to a next nondispensing position to prevent leakeage or clogging or is further rotated to a next dispensing position in preparation for a second dispensing stroke. 
         FIG. 12  is a front left detail isometric view of an alternative band having detachable outer band layers for the multiple use fluid dispenser of  FIG. 1 . 
         FIG. 13  is a side view of the alternative band of  FIG. 12 . 
         FIG. 14  is a side view of another alternative band for the multiple use fluid dispenser of  FIG. 1  having two sequential non-dispensing positions. 
         FIG. 15  is a side view of an additional alternative band for the multiple use fluid dispenser of  FIG. 1  having an inner band layer removed at each dispensing. 
         FIG. 16  is a side view of a further alternative band for the multiple use fluid dispenser of  FIG. 1  having a continuous inner band layer and a segmented continuous outer band layer. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Turning to the Figures, wherein like numerals denote like components throughout the several views, in  FIGS. 1-2 , a multiple use fluid dispenser  10  applies a discrete, precise volume of a medically therapeutic flowable material (e.g., adhesive, sealant, drug, schlerosing/necrosing agent, etc.) without leaking or clogging before or between uses. A handle  12  includes a pistol grip  14  that is held by the surgeon for positioning an elongate shaft  16  to position a distal applicator tip  18  to a desired location as part of a topical, open or minimally invasive (e.g., laparoscopic, endoscopic) surgical procedure. Positioning an advancement knob  20  prepares the distal applicator tip  18  for the next dispensing application. Then, depression of a trigger  22  proximally toward the pistol grip  14  causes the dispensing application. The advancement knob  20  may then be turned to a next position to prevent leaking or clogging between dispensing operations. 
     In  FIGS. 3-4 , the housing  12  of the multiple use fluid dispenser  10  has left and right housing half shells  24 ,  26  that are generally laterally symmetric and fused along a seam  28 . The elongate shaft  16 , which includes an outer tube  30  with a proximal disk flange  32  extending outwardly, is engaged within a respective internal slot  34  surrounding a half circular hole  36  formed on a distal end of each housing half shell  24 ,  26 . 
     A coupling member  38  has a longitudinal through hole  40  to receive a proximal end  42  of narrow diameter fluid conduit  44  that is received within the outer tube  30  distally terminating in a dispensing orifice  46  at an open distal end  48  of the outer tube  30  at the distal applicator tip  18 . The coupling member  38  is laterally sized for engaging an inner diameter at a proximal end  50  of the outer tube  30  and vertically narrowed to leave room for a band  52  to pass around the coupling member  38  and the fluid conduit  44 . Laterally symmetric left and right tip supports  54 ,  56  are attached to each side of a distal end  58  of the fluid conduit  44 , supporting therebetween a top transverse roller  60  and a bottom transverse roller  62  that reside respectively above and below the fluid conduit  44  within the outer tube  30 . The assembled tip supports  54 ,  56  and rollers  60 ,  62  form a distal spacer  64  that contacts an inner diameter of the open distal end  48  of the outer tube  30  and is vertically narrowed to allow the band  52  to pass around the rollers  60 ,  62  and pass closely over the dispensing orifice  46  of the fluid conduit  44 . 
     In  FIGS. 5-6 , the band  52  is depicted as having left and right series of sprocket holes  66 ,  68  formed in a band substrate  70  similar to those formed in celluloid movie film. Intermittent center openings, depicted as circular holes  72  are formed in the band substrate  70  for being aligned with the dispensing orifice  46  of the fluid conduit  44  for dispensing the flowable material. An outer band layer, depicted as an outer rectangular patch  74 , is attached to the band substrate  72  and sized and positioned to surround the circular hole  72 . The outer rectangular patch  74  may be detachable, such as due to the flexure and friction by contact to tissue, by the chemical composition of the flowable material, and/or the fluid pressure imparted to an inner surface of the rectangular patch  74 . The detached patch  74  may serve as a bandage or buttress. Alternatively, the rectangular patch  74  may be permanently attached to the band substrate  70 , serving as a mesh to diffuse the dispensing of flowable material, serving to impart an activation compound to initiate polymerization, etc. In  FIG. 6 , the band  52  also includes an inner band layer, depicted as an inner rectangular patch  76 , are attached to an inner surface of the band substrate  70  spaced in between circular holes  72 . The inner rectangular patch  76  may serve to prevent leakage between dispensing, may prevent air and/or activation compounds from contacting the dispensing orifice  46  of the fluid conduit  44  to reduce or avoid clogging, may wipe the dispensing orifice  46 , etc. 
     Returning to  FIGS. 3-4 , the advancement knob  20  presented on the right, aft side of the handle  12  positions the band  52  to present these surfaces to the dispensing orifice  46  by having an indexing pin  78  that engages a series of radially spaced detents  80  which are formed on an exterior of the housing  12  around a shaft hole  82  on the right housing half shell  24 . A rightward advancement shaft  84  attached to the advancement knob  20  passes through the shaft hole  82  and is centrally engaged to a sprocket  86  and then rotatingly received within a cylindrical receptacle  88  presented by the left housing half shell  24 . The sprocket  86  engages the sprocket holes  66 ,  68  of the band  52  that passes approximately over an aft portion of a circumference of the sprocket  86 . A top portion of the band  52  goes forward from a top surface of the sprocket  86  into a close spacing between a laterally positioned top guide pin  90  below the top seam  28  of the housing  12  and then around a front top guide pin  92  and down to bend into the spacing above the coupling member  38  and then distally. A bottom portion of the band  52  goes down and forward from the sprocket  86  around a bottom aft guide pin  94  and forward around a front bottom guide pin  96  and up to bend forward below the coupling member  38  and then distally. 
     Fluid dispensing is provided by a syringe  97  formed by a syringe barrel  98  and a plunger  100 . A distal nozzle  102  of the syringe barrel  98  is sized to be received proximally into the longitudinal through hole  40  of the coupling member  38 , held therein by a circular boss  104  formed on both housing half shells  24 ,  26  to engage a proximal opening  106  of the syringe barrel  98 . The plunger  100  has a distal cylindrical plunger seal  108  that dynamically seals to an inner diameter of the syringe barrel  98  defining a syringe volume  109  containing flowable material and is positioned along a longitudinal axis defined by the syringe barrel  98  and fluid conduit  44  by a distal disk face  110  of a ratcheting plunger arm  112 , which proximally terminates in left and right lateral pins  114 ,  116  that longitudinally translate in a longitudinal track  118  formed on an interior of both handle half shells  24 ,  26 . An upper rack  120  formed into the ratcheting plunger arm  112  with proximally directed tooth vertical faces  122  between ramp surfaces  124  makes ratcheting engagement with a distally directed anti-backup pawl  126  pivoting about a pawl pin  128  between the half shells  24 ,  26  and biased downward into engagement by a torsion spring  130  received on a right side of the pawl pin  128 . 
     A top end  132  of the trigger  22  has a pivot hole  134  that is rotatably received upon a trigger axle  136  that passes laterally within a trigger aperture  138  formed on an undersurface of the housing  12  distal to the pistol grip  14 . A right post  140  is attached to the top end  132  of the trigger  22  extending upwardly within the housing to the right side of the band  52 . A left post  142  is assembled onto the top end  132  of the trigger  22  to the left of the band  52 . A spring mounting  144  extends laterally between the right and left posts  140 ,  142  to receive a distal end  146  of a compression spring  148 . A proximal end  150  of the compression spring  148  is received upon a lateral spring pin  152  extending between the half shells  24 ,  26 . A ratchet cam member  154  mounts on top of the posts  140 ,  142  and engages a lower rack  156  formed into a lower surface of the ratcheting plunger arm  112  with proximally directed tooth vertical faces  158  between ramp surfaces  160 . 
     It should be appreciated with the benefit of the present disclosure that an anti-backup mechanism and a trigger may utilize the same ratcheting rack segment in applications consistent with the present invention. In addition, rather than gear type engagement, a rod-binding engagement may be employed in applications consistent with the present invention, similar to caulking guns. 
     In use, in  FIG. 7  the multiple use fluid dispenser  10  is in an initial state with the syringe volume  109  fully filled and the plunger  100  fully retracted. The cam member  154  is engaged to a distal most position on the lower rack  156  with the trigger  22  fully forward under the biasing of the compression spring  148 . The plunger seal  108  is prevented from backing out of the syringe barrel  98  by the lateral pins  114 ,  116  of the plunger arm  112  residing within a proximal end of the longitudinal track  118  in the housing  12  as well as by the anti-backup pawl  126  engaged to a distal most position on the upper rack  120 . The advancement knob  20  has already rotated the band  52  into a dispensing position. 
     In  FIG. 8 , the trigger  22  is being depressed aft toward the pistol grip  14  stretching the compression spring  148 , distally advancing the cam member and thus the ratcheting plunger arm  112 . The anti-backup pawl  126  rides overtop of the upper rack  120 . The distal movement of the plunger seal  108  forces a displaced volume of flowable material within the syringe volume  109  out of the distal dispensing tip  18 . 
     In  FIG. 9 , the trigger  22  has reached its proximal most position as limited by the trigger aperture  138  in the housing  12 , corresponding to a position in which the anti-backup pawl  126  drops into a second distal most position of the upper rack  120 , holding the plunger  100  at this position. 
     In  FIG. 10 , the trigger  22  is released, thus moving forward under the released energy stored in the compression spring  148  while the syringe volume  109  is maintained. 
     In  FIG. 11 , the trigger  22  has reached its fully forward relaxed position as allowed by the trigger aperture  139  in the housing  12 . This position corresponds to the cam member  154  engaging a second distal most position of the lower rack  156  of the ratcheting plunger arm  112  positioned for a second dispensing stroke. The anti-backup pawl  126  remains engaged to the upper rack  120  until such second dispensing stroke. The advancement knob  20  is rotated to position the band  52  to either a non-dispensing position that may seal and/or wipe the dispensing orifice  46  of the fluid conduit  44  or position the band  52  to a dispensing position in preparation for the second dispensing stoke. 
     In  FIGS. 12-13 , an alternative band  200  for the multiple use fluid dispenser  10  of  FIG. 1  includes detachable outer band layers  202  over a respective circular hole  204  formed sequentially in a band substrate  206  that may serve as a bandage or buttressing material or an initiation site for the polymerization of dispensed flowable material. Inner band layers  208  are equidistantly spaced between circular holes  204  on an inner surface of the band substrate  206  for providing a non-dispensing position that mitigates premature activation, leaking, clogging, etc. 
     In  FIG. 14 , another alternative band  210  for the multiple use fluid dispenser  10  of  FIG. 1  includes outer band layers  212  over a respective circular hole  214  formed in a band substrate  216  and with two inner band layers  216  equidistantly spaced on an inner surface of a band substrate  216  for serving a first wiping surface followed by a clean sealing surface to further mitigate the likelihood of sticking or clogging between dispensing strokes. 
     In  FIG. 15 , an additional alternative band  220  for the multiple use fluid dispenser  10  of  FIG. 1  includes outer band layers  222  over a respective circular hole  224  formed in a band substrate  226  and with a continuous inner band layer  228  which covers an inner surface of the band substrate  226  except for the circular holes  224  for serving as a continuous wiping and sealing surface to further mitigate the likelihood of sticking or clogging between dispensing strokes. 
     In  FIG. 16 , a further alternative band  230  for the multiple use fluid dispenser  10  of  FIG. 1  includes adjacent outer band layers  232  over a respective, half-spaced circular hole  234  formed in a band substrate  236  and with a continuous and porous inner band layer  238  covering an inner surface of the band substrate  236  except for the circular holes  234  for serving as a dispersal mesh, continuous wiping and sealing surface to further mitigate the likelihood of sticking or clogging between dispensing strokes. 
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. 
     For clarity, it should be appreciated that a simplified tip has been depicted that may have particular advantages for open or topical surgical procedures. It should be appreciated that various modifications may be made such as making flexible or deformable or articulating shaft for increased flexibility in endoscopic or laparoscopic surgical procedures. Various pneumatic sealing features may be incorporated to assist in maintaining an insufflated body cavity for laparoscopic procedures. 
     It should be appreciated with the benefit of the present disclosure that terms such as fluid are intended to encompass a range of medically therapeutic flowable materials, to include emulsions, mixtures of liquids and solids, etc. Furthermore, for clarity, certain applicator tips have been illustrated; however, applicator tips consistent with aspects of the present invention may include various opening patterns, to include shape in a dispensing band may be employed, optimized for a given viscosity or other property of the dispensed flowable material. 
     As another example, applications consistent with the present invention may employ another type of fluid transfer apparatus to urge a pressurized volume of flowable material toward a distal dispensing orifice, such as a gas charged or spring biased plunger. A trigger or similar actuator may effect dispensing solely by rotation of the band to a position in which the flowable material is allowed to extrude out under inherent pressure. When dispensing is to conclude, reposition of the trigger, such as to a release state, rotates the band to a blocked, sealed position. Such rotation of the band may be reciprocating or looping in a constant direction depending on the characteristics of the flowable material. 
     As yet another example, applications consistent with the present invention may employ a tape that does not loop, but instead is unreeled from a storage reel, routed past a distal dispensing orifice and then reeled up on a take-up reel. Alternatively, a substrate may comprise a continuous loop but also include an intermediate storage reel similar to an 8-track cassette. 
     As yet a further example, while sprocket holes enhance positive positioning of the substrate, applications consistent with the present invention may employ a frictionally engaged substrate transport mechanism. 
     As another example, applications consistent with aspects of the present invention may include a visual indicator that alerts the user as to the remaining number or quantity of flowable material remaining or already dispensed and/or the number of dispensing operations allowable by the amount of unused band remaining. Furthermore, a lockout may seal off further dispensing once the band is exhausted of initiator layers or detachable layers. 
     As yet another example, while a multiple stroke trigger is illustrated, applications consistent with the present invention may include a single stroke trigger or a rotated actuator or a manually pushed syringe plunger.