Abstract:
A multiple use adhesive dispenser facilitates precise, extended dispensing for a surgical procedure by sequentially positioning an ampoule containing a flowable material, such as a polymerizable monomer compound such as a cyanoacrylate adhesive. In one version particularly suited to an open surgical procedure, the ampoules are affixed to a tape substrate that is unreeled from an internal storage reel and transported proximate to an ampoule gripping mechanism with an underlying tape substrate peeled away and internally stored as each ampoule is positioned for dispensing. Actuating an ampoule advancement handle positions the next ampoule and squeezing a movable handle toward a fixed handle effects dispensing. Another version has an elongate shaft that internally augers each ampoule in succession into a pair of spaced jaws that are pinched together by actuating rods to dispense adhesive.

Description:
REFERENCE TO RELATED APPLICATIONS 
   The present application is related commonly owned U.S. patent application Ser. No. 11/558,107 “SURGICAL BAND FLUID MEDIA DISPENSER”, to Voegele and Hunt 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 applicators and/or dispensers for dispensing and/or applying an adhesive material, for example, a polymerizable monomer compound such as a cyanoacrylate adhesive, particularly for open surgical use and minimally invasive surgical use. 
   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 alternate 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. 
   Recently, a DERMABOND PROPEN applicator system by CLOSURE MEDICAL CORPORATION, Raleigh, N.C. has become available that dispenses a high viscosity DERMABON™ topical skin adhesive product, available from ETHICON, INC. (Somerville, N.J.). Aspects of such applicators are disclosed in U.S. Pat. Appln. 2004/0190975 A1 “Applicators, dispensers and methods for dispensing and applying adhesive material” to Goodman published 30 Sep. 2004; U.S. Pat. Appln. 2003/0044219 A1 “MICROAPPLICATORS, DELIVERY SYSTEMS AND METHODS FOR ADHESIVES AND SEALANTS” to Quintero published 6 Mar. 2003; and U.S. Pat. No. 6,340,097 to D&#39;Alessio, the disclosures of which are hereby incorporated by reference in their entirety. These applicator systems substantially increase ease of use, adhesive control, expression efficiency, and precision placement over generally known surgical adhesive appliers. However, improvements are yet desired to further enhance these attributes and to incorporate additional advantages. 

   
     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 front isometric view of a multiple use adhesive dispenser for open surgical use that sequentially positions one of a plurality of ampoules each containing an polmerizable adhesive for dispensing. 
       FIG. 2  is a left front isometric view of the multiple use adhesive dispenser of  FIG. 1  with a right housing half shell removed to expose mechanisms capable of advancing tape substrate affixed ampoules. 
       FIG. 3  is a left front exploded view of the multiple use adhesive dispenser of  FIG. 1 . 
       FIG. 4  is a left side view in elevation taken in longitudinal cross section of the multiple use adhesive dispenser of  FIG. 1  with an ampoule advancement handle in a lowered, relaxed state. 
       FIG. 5  is a left side view in elevation taken in longitudinal cross section of the multiple use adhesive dispenser of  FIG. 4  with the ampoule advancement handle in a raise, actuated state. 
       FIG. 6  is a left side view in elevation taken in longitudinal cross section of the multiple use adhesive dispenser of  FIG. 5  with an ampoule advancement handle being released back to the lowered, relaxed state, advancing an ampoule into position for dispensing while peeling away and storing an underlying portion of the tape substrate. 
       FIG. 7  is a left side view in elevation taken in longitudinal cross section of the multiple use adhesive dispenser of  FIG. 6  with a proximal movable handle raised toward a proximal fixed handle to dispense adhesives by crushing the distal most ampoule. 
       FIG. 8  is a left side view in elevation of an alternative multiple use adhesive dispenser for a minimally invasive surgical procedure that sequentially positions one of a plurality of ampoules each containing a polmerizable adhesive for dispensing. 
       FIG. 9  is a left front isometric view of a distal portion of the alternative multiple use adhesive dispenser of  FIG. 8 . 
       FIG. 10  is a left front isometric view of the distal portion of the alternative multiple use adhesive dispenser of  FIG. 9  taken in vertical cross-section along a longitudinal axis to expose the plurality of ampoules being positioned for sequential dispensing. 
       FIG. 11  is a left front exploded view of the distal portion of the alternative multiple use adhesive dispenser of  FIG. 8 . 
       FIG. 12  is a left side view in elevation of the distal portion of the alternative multiple use adhesive dispenser of  FIG. 9  taken in vertical cross-section along a longitudinal axis to expose the plurality of ampoules being positioned for sequential dispensing. 
       FIG. 13  is a left side view in elevation of the distal portion of the alternative multiple use adhesive dispenser of  FIG. 12  taken in vertical cross-section along a longitudinal axis to expose the plurality of ampoules being positioned for sequential dispensing and a distal most ampoule being crushed between an upper and a lower jaw. 
       FIG. 14  is a left side view in elevation of the ampoule dispensed by the multiple use adhesive dispenser of  FIG. 1  with internal structure and contents depicted in phantom. 
       FIG. 15  is a front side view in elevation of the ampoule of  FIG. 14  depicting an X-shaped perforation in an outer resilient bladder and with internal structure and contents depicted in phantom. 
       FIG. 16  is a left side view in elevation of the ampoule of  FIG. 14  in vertical cross section along a longitudinal axis. 
       FIG. 17  is a left side view in elevation of the ampoule of  FIG. 16  as the ampoule is crushed for dispensing drops of adhesive. 
       FIG. 18  is a left side view of an alternative ampoule with internal structure and contents depicted in phantom and a flat bottom surface for dispensing by the multiple use adhesive dispenser of  FIG. 8 . 
       FIG. 19  is front side view in elevation of the alternative ampoule of  FIG. 18  depicting an X-shaped perforation in an outer resilient bladder and with internal structure and contents depicted in phantom. 
       FIG. 20  is a left side view of the alternative ampoule of  FIG. 18  with internal structure and contents depicted in phantom and releasably adhesively affixed to a tape substrate. 
       FIG. 21  is a front side view in elevation of the alternative ampoule of  FIG. 20  with internal structure and contents depicted in phantom and releasably adhesively affixed to the tape substrate. 
       FIG. 22  is a left side view of another alternative ampoule with internal structure and contents depicted in phantom and a mounting flange integral to an outer resilient bladder sandwiched into a composite tape substrate for dispensing by the multiple use adhesive dispenser of  FIG. 8 . 
       FIG. 23  is a front side view of the another alternative ampoule of  FIG. 22  depicting an X-shaped perforation and with internal structure and contents depicted in phantom. 
       FIG. 24  is a left side view of two additional alternative ampoules with internal structure and contents depicted in phantom and with an outer resilient bladder around each ampoule extending between ampoules as a tape substrate for dispensing by the multiple use adhesive dispenser of  FIG. 8 . 
       FIG. 25  is a front side view of one of the additional alternative ampoules of  FIG. 24  in vertical cross section. 
       FIG. 26  is a left side view in vertical cross section along a longitudinal axis of a further alternative ampoule having a distal foam applicator tip. 
       FIG. 27  is a left side view in vertical cross section along the longitudinal axis of the further alternative ampoule of  FIG. 26  during dispensing. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Turning to the Figures, wherein like numerals denote like components throughout the several views, in  FIG. 1 , a multiple use adhesive dispenser  10  for open surgical use includes a housing  12  that contains a plurality of frangible ampoules  14  containing an amount of polymerizable adhesive that may be sequentially dispensed so that a single adhesive dispenser  10  may be used repeatedly to dispense discrete amounts of adhesive. 
   The housing  12  is formed by outwardly laterally symmetric right and left housing half shells  16 ,  18  joined along an upper seam  20  to form a distal mechanism compartment  22  and a proximal fixed handle  24 . A distal vertical rectangular slot  26  is defined between the housing half shells  16 ,  18  to allow translation of a distal jaw portion  28  within the distal mechanism compartment  22  attached to a proximal movable handle  30  that extends proximally below the proximal fixed handle  24  out of a lower elongate opening  32  also defined between the housing half shells  16 ,  18 . A ratcheting actuator  34  also translates within the lower elongate opening  32 . One ampoule  14  at a time is deposited in a generally cylindrically round dispensing channel  36  defined between a lower portion of the distal vertical rectangular slot  26  and the distal jaw portion  28 , open distally, and communicating upwardly with the distal vertical rectangular slot  26 . 
   The frangible ampoules  14  may be made of any suitable material, preferably a material that promotes stability and shelf-life of the polymerizable adhesive material. For example, the frangible ampoule  14  may be made of glass. Other materials, such as, a plastic material or pierceable metal, such as aluminum, may be used for the frangible ampoule  14 . An example of a suitable ampoule that can be used in the dispenser/applicators of the present invention is disclosed in, for example, U.S. Pat. No. 5,928,611, the entire disclosure of which is incorporated herein by reference. The adhesive dispenser  10  or other versions described herein are particularly suitable for dispensing or applying the adhesive contained in the DERMABON™ topical skin adhesive product, available from ETHICON, INC. (Somerville, N.J.). 
   In  FIGS. 2-4 , the ampoules  14  are releasably adhered at regular intervals upon a top surface  38  of an elongate dispensing band or tape  40  stored with the top surface  38  outward upon a reel  42  that rotates about a lateral reel axle  44  that extends from the right housing half shell  18  and is engaged to the left housing half shell  16 . The reel  42  includes a left disk  46  and a right disk  48  that includes a central hub portion  50 . The tape  38  passes over a top surface  52  of a wedge-shaped lateral block  54  aligned with but closely spaced from a top surface  56  of a distal block  58  of the dispensing channel  36  forming a peel-off slot  59 , both blocks  54 ,  58  extending from the right housing half shell  18  and abutting the left housing half shell  16 . The close spacing of the peel-off slot  59  between the blocks  54 ,  58  is sufficient to receive the tape  38  but too narrow for receiving an ampoule  14 . The tape  38  passes down the peel-off slot  59  between the blocks  54 ,  58  and proximally below the wedge shaped lateral block  54 , into a radial outer slot  60  formed in a ratcheting take-up wheel  62 . Left and right ratchet gears  64  (the latter hidden but identical to the left) extend laterally from each side of a flat cylindrical disk  68  of the ratcheting take-up disk  62  that rotates about a take-up axle  70  laterally extending from the left housing half shell  18  and engaged by the right housing half shell  16 . 
   Each ratchet gear  64  is shaped to engage a top aft moving left and right hook arm  72 ,  74 , respectively, of the ratcheting actuator  34  that curve up and distally from a left and right half of an aft end  76  of an ampoule advancement handle  78  whose distal end  80  pivots about an axle  82  below the wedge shaped lateral block  54  that extends from the right housing half shell  18 . A clip spring  84  has a bent end  86  that is captured proximally between closely spaced top and bottom posts  88 ,  90  that also extend from the right housing half shell  18  proximal to and above the axle  80 . A long biasing portion  92  of the clip spring  82  extends downwardly and aft to contact a top surface  94  of the advancement handle  78 , biasing the aft end  76  of the advancement handle  78  downwardly. The tape  38  is pulled away from a distal most ampoule  14  that is received between the distal jaw portion  28  and the top surface  56  of the distal block  58  by the tape  38  being rolled onto the ratcheting take-up wheel  62 . 
   Above the wedge-shaped lateral block  54 , a handle pivot axle  96  that extends laterally from the right housing half shell  18  passes through a pivot hole  98  formed at a transition between the distal jaw portion  28  and the much longer proximal movable handle  30 . The maximum spacing between the distal jaw portion  28  and the distal block  58  is selected such that an ampoule  14  is firmly gripped without crushing when the advancing tape  38  urges an ampoule  14  there between. 
   In  FIG. 5 , the ampoule advancement handle  94  has been manually pushed upward into the distal mechanism compartment  22  such that the hook arms  72 ,  74  move approximately a quarter turn around the ratchet gears  64  to reengage another ratchet tooth  100 . In  FIG. 6 , the ampoule advancement handle  94  is released, allowing the clip spring  84  to rotate the handle  94  downward, thereby rotating the ratcheting take-up wheel  62  to reel up an additional interval of tape  38 . In  FIG. 7 , the movable handle  30  has been squeezed against the fixed handle  24 , causing an ampoule  14  to be crushed, dispensing adhesive drops  102 . 
   In  FIGS. 10-13 , an alternative multiple use adhesive dispenser  110  for minimally invasive surgical use has an elongate shaft  112  for passing endoscopically through a body orifice (e.g., throat) or laparoscopically through a surgical access (e.g., incision, trocar) (not shown). The shaft  112  comprises an outer tube  114  that may be rigid, flexible or deformable. The shaft  112  is connected proximally to a rotation knob  116  that in turn is coupled for rotation to a handle  118 . The shaft  112  is distally connected to an end effector, depicted as an upper and a lower jaw  120 ,  122  configured to move between a parallel spaced orientation (“open”) to receive an ampoule  14  and a distally pinched orientation (“closed” or “dispensing”). A clinician grasps the handle  118  by inserting a thumb into a thumb ring  124  of an upper pivoting trigger  126  and a first two fingers into a finger ring  128 , which is forward and slightly below of the thumb ring  124  and which is part of a lower fixed member  130  that projects downwardly from a barrel portion  132  attached to the rotation knob  116  and shaft  112 . In response to actuating the upper pivoting trigger  126  toward the lower fixed member  130 , distal ends of the jaws  120 ,  122  are pinched together, crushing the ampoule  14 . Retracting the upper pivoting trigger  126  advances another ampoule  14  into the opened jaws  120 ,  122 . 
   The shaft  112  includes a generally cylindrical elongate frame  134  that is received within the outer tube  114 . A distal end  136  of the frame  134  includes a central hole  138  slightly larger than a lateral diameter of the ampoules  14 . With particular reference to  FIG. 10 , an internal cylindrical cavity  140  of the frame  134  has an internal diameter slightly larger than twice the lateral diameter of the ampoules  14  and transitions distally to a tapered nozzle portion  142  down distally to the central hole  138 . An ampoule guide rod  144  extends from a proximal connection (not shown) to the handle  118  down a longitudinal center axis of the frame  134  and outer tube  114 , urging each sequentially lined up ampoule  14  between coils  146  of an advancement spring  148  closely sized to the internal cylindrical cavity  140 . For the depicted orientation of the coils  146 , counterclockwise rotation of the advancement spring  148 , as viewed from a distal orientation, urges the ampoules  14  distally. The ampoule guide rod  144  distally terminates prior to the tapered nozzle portion  142 , allowing each ampoule  14  in turn to ramp inwardly through the central hole  138  to be received by the jaws  120 ,  122 . A left and a right mounting tab  150 ,  152  are attached to an outer circumference  154  proximate to the distal end  136  of the frame  134 , oriented on opposite sides of the central hole  138  and projecting further distally to present respective left and right pivot holes  156 ,  158  for pivotal mounting of the jaws  120 ,  122 . 
   With particular reference to  FIG. 10 , each jaw  120 ,  122  is identical to the other and assembled with one jaw  120  rotated 180° about the longitudinal axis relative to the other jaw  122 . Each jaw  120 ,  122  has a distally extending anvil portion  160  that is positioned by a jaw mounting portion  162  to reside approximately between the outer circumference  154  and the central hole  138  of the frame  134  (i.e., above and below respectively for jaws  120 ,  122 ). Each anvil portion  160  has a flat inner surface  163  that transitions to a small, inwardly ramped distal portion  164  to capture the distal most ampoule  14  ( FIGS. 9-10 ). Each mounting portion  162  comprises a half cylindrical band  165  attached at one counterclockwise end  166  (as viewed from a distal orientation) to a proximal surface of the anvil portion  160  wrapping clockwise around and distal to the central hole  138  as viewed from a distal position to a free clockwise end  168 . An outer flattened surface  170  midway around the half cylindrical band  165  between the counterclockwise and clockwise ends  166 ,  168  has a side pivot hole  172  that is positioned inside of a respective mounting tab  156 ,  158  and is rotatably attached by a pivot pin  174 . The free clockwise end  168  has an outwardly extending, transversely aligned clevis  176  that receives a distal eyelet end  180  of a respective upper and lower actuating rod  182 ,  184 , which are held therein by a respective clevis pin  185 , each actuating rod  182 ,  184  received for longitudinal translation between the outer tube  114  and the frame  134  to communicate a closing motion from the handle  118 . 
   In  FIG. 12 , action by a distal termination  186  of the advancement spring  148  is brushing a proximal end of an ampoule  14  that is partially extending through the central hole  138 , preventing a distal most ampoule  14  within the jaws  120 ,  122  from retracting. In  FIG. 13 , the upper and lower actuating rods  182 ,  184  are longitudinally advanced, causing the upper and lower jaws  120 ,  122  to rotate inwardly about their side pivot holes  172  that are connected to the frame  134  of the shaft  114  ( FIG. 9 ). Thereby, the ampoule  14  is crushed, ejecting drops of adhesive  102 . 
   In  FIGS. 14-17 , the ampoule  14  is depicted as having a composite containment structure  188  comprised of an outer resilient bladder  190  that closely encompasses a frangible capsule  192  that contains a quantity of adhesive  102  and air  194 . In  FIG. 15 , a distal end  196  of the outer resilient bladder  190  has an X-shaped perforation  198 . In  FIG. 17 , lateral compression of the ampoule  14  within the multiple use adhesive dispenser  10  ( FIG. 1 ) causes the frangible capsule  192  to fracture with the fluid pressure directed by bladder  196  to the X-shaped perforation  198 , resulting in rupture and the ejection of droplets of adhesive  102 . 
   In  FIGS. 18-21 , an alternative ampoule  14   a  is depicted as having a flat bottom composite containment structure  208  comprised of an outer resilient bladder  210  that closely encompasses a frangible capsule  212  that contains a quantity of adhesive  102  and air  194 . In  FIG. 19 , a distal end  214  of the outer resilient bladder  210  has an X-shaped perforation  216 . A releasable adhesion layer  218  holds a flat bottom surface  220  of the composite containment structure  208  to a tape substrate  222  for use in the multiple use adhesive dispenser  110  ( FIG. 8 ) or similar devices. 
   In  FIGS. 22-23 , another alternative ampoule  14   b  is depicted as having a flat bottom composite containment structure  228  comprised of an outer resilient bladder  230  that closely encompasses a frangible capsule  232  that contains a quantity of adhesive  102  and air  194 . In  FIG. 23 , a distal end  234  of the outer resilient bladder  230  has an X-shaped perforation  236 . The outer resilient bladder  230  includes a releasable mounting flange  238  that extends horizontally around a flat bottom surface  240  of the composite containment structure  208 . A composite tape substrate  242  for use in the multiple use adhesive dispenser  110  ( FIG. 1 ) or similar devices has a lower substrate  244  upon which the flat bottom surface  240  and releasable mounting flange  238  are placed. An upper substrate  246  affixed to the lower substrate  244  surrounds the ampoule  14   b  and releasably holds down the releasable mounting flange  238 . 
   In  FIGS. 24-25 , an additional alternative ampoule  14   c  is depicted as having a flat bottom composite containment structure  248  comprised of an outer resilient bladder  250  that closely encompasses a flat bottomed frangible capsule  252  that contains a quantity of adhesive  102  and air  194 . A distal end  254  of the outer resilient bladder  250  has an X-shaped perforation  256 . The same resilient material that encompasses the frangible capsule  252  extends between ampoules  14   c  to form an integral tape substrate  258  for use in the multiple use adhesive dispenser  110  ( FIG. 1 ) or similar devices. 
   In  FIGS. 26-27 , a further alternative ampoule  14   d  is depicted as having the composite containment structure  188  comprised of the outer resilient bladder  190  that closely encompasses a frangible capsule  192  that contains a quantity of adhesive  102  and air  194 . The distal end  196  of the outer resilient bladder  190  has an X-shaped perforation  198 . A foam applicator tip  260  covers the distal end  196  and extends distally. In  FIG. 27 , lateral compression of the ampoule  14   d  within the multiple use adhesive dispenser  10  ( FIG. 1 ) causes the frangible capsule  192  to fracture with the fluid pressure directed by bladder  196  to the X-shaped perforation  198 , resulting in rupture and the ejection of droplets of adhesive  102  into the foam applicator tip  260 . 
   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 example, rather than a polymerizable monomer compound such as a cyanoacrylate adhesive, a two-part adhesive may be incorporated into an ampoule, separated by a frangible barrier that allows mixing during dispensing. 
   As another example, a plurality of ampoules may remain affixed to a tape substrate with the crushed ampoule and underlying tape substrate being reeled into storage after dispensing. 
   As an additional example, rather than pushing the opposing jaws closed with actuating rods, reduction in a diameter of a minimally invasive surgical instrument may be realized by changing the jaws such that pulling may effect closing, thus additional force through an actuation member capable of additional force in tension than compression may allow a smaller mechanization. 
   As yet a further example, while a spring and a guide rod are illustrative of an augering advancement of individual ampoules, applications consistent with the present may employ other distally moving mechanisms such as a Archimedes screw, a conveyor belt with engagement compartments, etc.