US20110060361A1 - Reconstitution and applicator system for wound sealant product - Google Patents
Reconstitution and applicator system for wound sealant product Download PDFInfo
- Publication number
- US20110060361A1 US20110060361A1 US12/877,889 US87788910A US2011060361A1 US 20110060361 A1 US20110060361 A1 US 20110060361A1 US 87788910 A US87788910 A US 87788910A US 2011060361 A1 US2011060361 A1 US 2011060361A1
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- United States
- Prior art keywords
- syringe barrel
- engagement region
- syringe
- barrel
- screen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000000565 sealant Substances 0.000 title description 8
- 238000000034 method Methods 0.000 claims description 14
- 239000003085 diluting agent Substances 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 238000000151 deposition Methods 0.000 claims 1
- 108090000190 Thrombin Proteins 0.000 description 7
- 229960004072 thrombin Drugs 0.000 description 7
- 239000000203 mixture Substances 0.000 description 5
- 239000000843 powder Substances 0.000 description 5
- 239000007788 liquid Substances 0.000 description 3
- 238000004891 communication Methods 0.000 description 2
- 230000002439 hemostatic effect Effects 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000008240 homogeneous mixture Substances 0.000 description 1
- 210000003127 knee Anatomy 0.000 description 1
- 238000003032 molecular docking Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
Images
Classifications
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- B01F25/451—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture
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- B01F25/452—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces
- B01F25/4521—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through orifices in elements, e.g. flat plates or cylinders, which obstruct the whole diameter of the tube
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- B01F25/452—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces
- B01F25/4523—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through sieves, screens or meshes which obstruct the whole diameter of the tube
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- B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
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- B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
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- B01F35/716—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components
- B01F35/7161—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components the containers being connected coaxially before contacting the contents
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B01F35/716—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components
- B01F35/7163—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components the containers being connected in a mouth-to-mouth, end-to-end disposition, i.e. the openings are juxtaposed before contacting the contents
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- B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
- B01F35/7174—Feed mechanisms characterised by the means for feeding the components to the mixer using pistons, plungers or syringes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/75—Discharge mechanisms
- B01F35/754—Discharge mechanisms characterised by the means for discharging the components from the mixer
- B01F35/75425—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
Definitions
- This disclosure relates generally to systems for applying a sealant to a work surface and, more specifically, to a system for mixing or reconstituting components of a two-component tissue sealant and delivering the mixed components into and through a cannula for delivery to a tissue site, or directly from a syringe to a tissue site.
- a large bore syringe reduces the force necessary to reconstitute the contents of the docked syringes (such as by pouring the contents back and forth between the two syringes).
- a standard large bore syringe will undesirably permit thrombin to drain back into the bowl.
- the hemostatic matrix tends to form clumps of material which hinder the ability to prepare a homogeneous mixture.
- the system of the present disclosure achieves reliable retention of dry powdered agents to be reconstituted, such as lyophilized thrombin, and also allows more efficient and homogenous mixing of a diluent and the powdered agent to be reconstituted.
- FIG. 1 is a perspective view of a male syringe barrel and a female syringe barrel of a first embodiment of the present disclosure, engaged with one another;
- FIG. 2 is a perspective view of the male syringe barrel of FIG. 1 ;
- FIG. 3 is a perspective view of the female syringe barrel of FIG. 1 ;
- FIG. 3A is a perspective view of the female syringe barrel of FIG. 3 , with a portion of an engagement region of the female syringe barrel cut away;
- FIG. 4 is a cross-sectional view of the male syringe barrel of FIG. 2 , taken along lines- 4 - 4 of FIG. 2 ;
- FIG. 5 is a cross-sectional view of the female syringe barrel of FIG. 3 , taken along lines- 5 - 5 of FIG. 3 ;
- FIG. 6 is a plan view of the male syringe barrel of FIG. 2 , taken along lines 6 - 6 of FIG. 2 ;
- FIG. 7 is a plan view of the female syringe barrel of FIG. 3 , taken along lines 7 - 7 of FIG. 3 ;
- FIG. 8 is a top plan view of a male syringe barrel engaged with a female syringe barrel, illustrating alignment of the flanges of the respective syringe barrels when the syringe barrels are engaged with one another, and with broken lines indicating a preferred maximum angular off-set of the flanges of the respective syringe barrels;
- FIG. 9 is an enlarged cross-section view, broken away, of engagement regions of the male syringe barrel and the female syringe barrel of FIG. 1 when the syringe barrels are engaged with one another, taken along line 9 of FIG. 1 ;
- FIG. 10 is an exploded perspective view of the female syringe barrel of FIG. 3 , with an adapter;
- FIG. 11 is a perspective view of the syringe barrel and adapter of FIG. 10 , in communication with a cannula handle and cannula, with a portion of the cannula broken away;
- FIG. 12 is a perspective view of the syringe barrel and adapter of FIG. 10 , in communication with a syringe barrel with integrated handle;
- FIG. 13 is a perspective view of the syringe barrel with integrated handle of FIG. 12 , with a cannula handle and cannula, with a portion of the cannula broken away;
- FIG. 14 is a plan view of a male syringe barrel similar to FIG. 6 , illustrating a screen of a first alternate embodiment of the present disclosure
- FIG. 15 is a plan view of a male syringe barrel similar to FIG. 6 , illustrating a screen of a second alternate embodiment of the present disclosure
- FIG. 16 is a plan view of a male syringe barrel similar to FIG. 6 , illustrating a screen of a third alternate embodiment of the present disclosure
- FIG. 17 is a plan view of a male syringe barrel similar to FIG. 6 , illustrating a screen of a fourth alternate embodiment of the present disclosure.
- FIG. 18 is a cross-sectional view of the screen of the male syringe barrel of FIG. 17 , taken along lines 18 - 18 of FIG. 17 .
- the system of the present disclosure includes a first syringe barrel 10 and a second syringe barrel 12 .
- the first syringe barrel 10 includes a male engagement region 14 and the second syringe barrel 12 includes a female engagement region 16 .
- the male engagement region 14 and the female engagement region 16 may each be provided with a screen 18 , 20 that serves to partially seal the respective barrel interior.
- the screen 18 , 20 may take the form of a mesh screen with a plurality of round openings 22 .
- the openings 22 may all be of equal size, or may be of varying sizes.
- Each of the screen 18 , 20 serves to retain fluid in the respective syringe barrel 10 , 12 even when uncapped and unengaged.
- the screens 18 , 20 also serve as mixing elements that aid in expediting the mixing of contents passing through the openings 22 . It is found that tissue sealant constituents of relatively low viscosity, such as thrombin, can be reconstituted with a lower number of pours or swooshes when being mixed between the first and second syringe barrels 10 , 12 of the present disclosure, as compared with conventional syringe barrels.
- the first syringe barrel 10 includes a main chamber 24 defined by a cylindrical barrel wall 26 , an open proximal end 28 sized to receive a plunger 30 , and a distal end 32 .
- the distal end 32 includes a screen 18 .
- the axially-extending male engagement region 14 includes a cylindrical inner wall 34 and a cylindrical outer wall 36 , separated from one another by at least one, and preferably two, female threads 38 forming a threaded channel 40 open at the distal end 32 of the first syringe barrel 10 , radially outward of the screen 18 .
- the inner wall 34 and outer wall 36 of the axially-extending male connecting region 14 come together at a neck portion 42 of the first syringe barrel 10 .
- a pair of opposing flanges 44 , 46 project radially outwardly from the cylindrical barrel wall 26 , preferably spaced a distance of approximately 0.3 inch from the proximal end 28 of the first syringe barrel 10 .
- the flanges 44 , 46 may each include a plurality of gripping ribs 48 on at least the surface of the flange facing the distal end 32 of the first syringe barrel 10 .
- the second syringe barrel 12 includes a main chamber 50 defined by a cylindrical barrel wall 52 .
- the cylindrical barrel wall 52 extends from an open proximal end 54 of the second syringe barrel 12 to a neck portion 56 near a distal end 58 of the second syringe barrel 12 .
- the axially-extending female engagement region 16 extends distally of the neck portion 56 .
- the screen 20 extends across the neck portion 56 , separating the main chamber 50 of the second syringe barrel 12 from an interior of the female engagement region 16 .
- the exterior of an axially-extending cylindrical wall 60 of the female engagement region 16 of the second syringe barrel 12 is provided with at least one, and preferably two, male threads 62 .
- the male threads 62 are of a complementary pitch to the female threads 38 of the threaded channel 40 of the first syringe barrel 10 .
- a pair of opposing flanges 64 , 66 project radially outwardly from the cylindrical barrel wall 52 , preferably spaced a distance of approximately 0.3 inch from the proximal end 54 of the second syringe barrel 12 .
- the flanges 64 , 66 may each include a plurality of gripping ribs 68 on a side of the flange facing the distal end 58 of the second syringe barrel 12 .
- the screen 18 of the first syringe barrel 10 and the screen 20 of the second syringe barrel 12 are in close proximity to one another.
- the screen 18 of the first syringe barrel 10 and the screen 20 of the second syringe barrel 12 are parallel to one another and spaced apart a distance d in a range from approximately 0.02 inch to 0.05 inch, preferably approximately 0.03 inch.
- the female threads 38 and the leading edges of the male threads 60 , 62 are positioned such that when the first syringe barrel 10 and second syringe barrel 12 are fully engaged with one another, with the male engagement region 14 seated in the female engagement region 16 , the flanges 44 , 46 of the first syringe barrel 10 are substantially aligned with the flanges 64 , 66 of the second syringe barrel 12 .
- the flanges 64 , 66 of the second syringe barrel 12 are no more than 10° out of alignment with the flanges 44 , 46 of the first syringe barrel 10 , as illustrated by the broken lines in FIG. 8 when the threads are fully threaded and fully torqued.
- the threads have a torque applied of approximately 2 lbf-in. when fully torqued.
- Each of the first syringe barrel 10 and second syringe barrel 12 may include an integral annular retaining rib 70 , 72 projecting inwardly from the cylindrical barrel wall 26 , 52 of the respective syringe barrel, near the open proximal end 28 , 54 .
- Each of the annular retaining ribs 70 , 72 serves to retain a sealing gasket of the plunger 30 , 74 received in the respective syringe barrel.
- a given quantity of a substance to be reconstituted in powdered form such as lyophilized thrombin
- a diluent or reconstituting agent such as calcium chloride solution or liquid thrombin
- the plunger 30 received in the open proximal end of the first syringe barrel 10 (although it will be recognized that the substance to be reconstituted may instead be initially provided in the first syringe barrel 10 , and the diluent may be provided in the second syringe barrel 12 ).
- the screen 20 of the second syringe barrel 12 retains the powder in the main chamber 50 of the second syringe barrel 12 while the powder is dry.
- the first syringe barrel 10 and second syringe barrel 12 are then engaged with one another by inserting the male engagement region 14 of the first syringe barrel 10 into the female engagement region 16 of the second syringe barrel 12 , with the male threads 62 extending outwardly from the axially-extending cylindrical wall 60 of the female engagement region 16 received in the female threads 38 of the threaded channel 40 of the male engagement region 14 .
- the flanges 44 , 46 of the first syringe barrel 10 are preferably substantially aligned with the flanges 64 , 66 of the second syringe barrel 12 .
- the plunger 30 of the first syringe barrel 10 i.e. the syringe barrel having the diluent, is pushed to force the liquid into the second syringe barrel 12 , the solid-bearing syringe barrel.
- the plunger 74 of the second syringe barrel 12 (which now also contains the diluent) is pushed to inject the mixture back across the two screens 18 , 20 into the first syringe barrel 10 . This process is repeated until the desired consistency is achieved. This is process of injecting the contents of one syringe barrel into another, then back into the first, is referred to as “swooshing”.
- the force necessary to mix the contents of the two syringe barrels 10 , 12 and the number of times the engaged syringe barrels 10 , 12 must be swooshed to complete reconstitution is reduced, relative to conventional docking syringe barrels used for mixing or reconstituting their contents, and this is believed to be a benefit of the closely-spaced screens 18 , 20 .
- the size and concentration of the openings 22 also influences the efficiency with which the contents of the syringe barrels may be mixed. In addition, the homogeneous quality of the mixture is improved.
- alternate embodiments for the screens 18 , 20 wherein the openings 22 take different shapes or forms, are contemplated within the scope of the present disclosure.
- the screens 18 , 20 may be made using a mesh of material, such as “Polypropelene Plastic Mesh,” McMaster-Carr part number 9265T41, having openings sized 0.021′′ ⁇ 0.027′′.
- the syringe barrels 10 , 12 are preferably tilted so the reconstituted solution is poured into the second syringe barrel 12 .
- the syringe barrels 10 , 12 are then disengaged from one another, and as illustrated in FIG. 10 , an adapter 76 having an engagement region similar to the male engagement region 14 of the first syringe barrel 10 , is secured to the female engagement region 16 of the second syringe barrel 12 .
- the adapter 76 may be connected to a conventional cannula handle 78 and cannula 80 , as illustrated in FIG. 11 .
- the cannula 80 may be introduced into the body of a patient adjacent a target tissue site.
- the plunger 74 on the second syringe barrel 12 may then be used to force the reconstituted solution into the cannula 80 and onto the target tissue site to act as a tissue sealant.
- the second syringe barrel 12 and adapter 76 may be attached to a syringe barrel 82 with an integrated handle 84 , as illustrated in FIG. 12 .
- the reconstituted contents of the second syringe barrel 12 may then be pushed into the syringe barrel 82 by pushing on the plunger 74 of the second syringe barrel 12 .
- the syringe barrel 82 is preferably provided with a one-way check valve 90 , as illustrated in FIG. 13 .
- the syringe barrel 82 is then detached from the second syringe barrel 12 and adapter 76 , and connected to the cannula handle 78 and cannula 80 .
- the syringe barrel 82 may then be used to introduce the reconstituted solution into the cannula by pressing on the stem 86 , thereby advancing the plunger 88 into the syringe barrel 82 , and thereby injecting the reconstituted solution into the cannula 80 .
- the one-way check valve 90 permits the medical professional, after the reconstituted solution has been introduced into the cannula 80 , to pull back the stem 86 and plunger 88 a second time, thereby drawing air into the empty syringe barrel 82 .
- the stem 86 and plunger 88 may then be advanced a second time, pushing the air into the cannula 80 . This pressurizes the air in the cannula and the pressure then advances the reconstituted solution farther down the length of the cannula 80 .
- the stem 86 and plunger 88 may be used to repeatedly draw air into the syringe 82 and advance the air into the cannula 80 until the desired amount of reconstituted solution is injected onto the target tissue site.
- tissue sealant that has been reconstituted using the system of the present disclosure may be applied to the internal target tissue site directly from either the syringe barrel 82 or the second syringe barrel 12 , without the use of a cannula 80 .
- the screens 18 , 20 of the first and second syringe barrels 10 , 12 may have forms other than a mesh.
- a first alternate embodiment of the screen 20 of the second syringe barrel 12 may take the form of a circular opening 92 having a plurality of spaced, inwardly-directed protuberances or bumps 94 .
- the inwardly-directed protuberances or bumps 94 may be arranged with each of four bumps 94 disposed at 45° intervals along the interior of the circular opening 92 .
- a second alternate embodiment of the screen 20 may take the form of a circular opening 96 provided with a pair of bar-like elements 98 arranged in a cross configuration.
- a third alternate embodiment of the screen 20 may take the form of a disc 100 having a plurality of cantilevered wedges or flaps 102 defining slots therebetween.
- four flaps 102 are provided, defining four slots 104 in the disc 100 .
- each of the slots 104 has a length of approximately 0.377′′ and a width of approximately 0.015′′, yielding a cross-sectional flow area of approximately 0.011085 in 2 .
- the screen 20 takes the form of a disc 106 having eight cantilevered wedges or flaps 108 , defining eight slots 110 in the disc 106 .
- each of the slots 110 has a length of approximately 0.377′′ and a width of approximately 0.015′′, yielding a cross-sectional flow area of approximately 0.021945 in 2 .
- the number and dimensions of the slots 104 , 110 in the third and fourth alternate embodiments of the screen 20 will impact the degree to which any retained powder in the main chamber 50 of the second syringe barrel 12 will break apart and mix upon initial and subsequent tilting back-and-forth of the engaged first and second syringe barrels 12 .
- the number and dimensions of the slots 104 , 110 will also determine the effectiveness of retention of dry powder in the main chamber 50 when the second syringe barrel 12 is uncapped.
- the cantilevered wedges or flaps 108 of the fourth alternate embodiment may be of a thickness that tapers from a perimeter 112 of the screen 20 toward a tip 114 of each of the flaps 108 .
- the flaps 108 which are preferably plastic, are free to bend in the direction of flow during mixing.
- the slots 110 increase in width during each pour across the screen 20 , thereby reducing the resistance to flow.
Abstract
A system for mixing or reconstituting agents including engageable syringe barrels, one of which having a male engagement region and the other a female engagement region. Each of the male and female engagement regions is provided with a screen. The screens are closely spaced from one another when the first and second syringe barrels are engaged with one another. The screens may take the form of a mesh, a plurality of protuberances, or cantilevered wedges having tapering thicknesses.
Description
- Pursuant to 35 U.S.C. §119(e), this application claims the benefit of the filing date of U.S. Provisional Application No. 61/204,586, filed Sep. 8, 2010, the entirety of which is incorporated herein by reference.
- 1. Field of the Disclosure
- This disclosure relates generally to systems for applying a sealant to a work surface and, more specifically, to a system for mixing or reconstituting components of a two-component tissue sealant and delivering the mixed components into and through a cannula for delivery to a tissue site, or directly from a syringe to a tissue site.
- It is known to mix or reconstitute components of sealants prior to introduction into a tissue wound site. For instance, a known technique for preparing thrombin and fibrinogen for use as a tissue sealant is to pull thrombin in a liquid form from a bowl into a large bore syringe barrel, dock the large bore syringe barrel with another syringe containing a dry hemostatic matrix powder, and mix the contents of the two syringes. A large bore syringe reduces the force necessary to reconstitute the contents of the docked syringes (such as by pouring the contents back and forth between the two syringes). However, a standard large bore syringe will undesirably permit thrombin to drain back into the bowl.
- It is also challenging to efficiently mix the contents of the two syringe barrels when docked with one another. The hemostatic matrix tends to form clumps of material which hinder the ability to prepare a homogeneous mixture. The system of the present disclosure achieves reliable retention of dry powdered agents to be reconstituted, such as lyophilized thrombin, and also allows more efficient and homogenous mixing of a diluent and the powdered agent to be reconstituted.
-
FIG. 1 is a perspective view of a male syringe barrel and a female syringe barrel of a first embodiment of the present disclosure, engaged with one another; -
FIG. 2 is a perspective view of the male syringe barrel ofFIG. 1 ; -
FIG. 3 is a perspective view of the female syringe barrel ofFIG. 1 ; -
FIG. 3A is a perspective view of the female syringe barrel ofFIG. 3 , with a portion of an engagement region of the female syringe barrel cut away; -
FIG. 4 is a cross-sectional view of the male syringe barrel ofFIG. 2 , taken along lines-4-4 ofFIG. 2 ; -
FIG. 5 is a cross-sectional view of the female syringe barrel ofFIG. 3 , taken along lines-5-5 ofFIG. 3 ; -
FIG. 6 is a plan view of the male syringe barrel ofFIG. 2 , taken along lines 6-6 ofFIG. 2 ; -
FIG. 7 is a plan view of the female syringe barrel ofFIG. 3 , taken along lines 7-7 ofFIG. 3 ; -
FIG. 8 is a top plan view of a male syringe barrel engaged with a female syringe barrel, illustrating alignment of the flanges of the respective syringe barrels when the syringe barrels are engaged with one another, and with broken lines indicating a preferred maximum angular off-set of the flanges of the respective syringe barrels; -
FIG. 9 is an enlarged cross-section view, broken away, of engagement regions of the male syringe barrel and the female syringe barrel ofFIG. 1 when the syringe barrels are engaged with one another, taken alongline 9 ofFIG. 1 ; -
FIG. 10 is an exploded perspective view of the female syringe barrel ofFIG. 3 , with an adapter; -
FIG. 11 is a perspective view of the syringe barrel and adapter ofFIG. 10 , in communication with a cannula handle and cannula, with a portion of the cannula broken away; -
FIG. 12 is a perspective view of the syringe barrel and adapter ofFIG. 10 , in communication with a syringe barrel with integrated handle; -
FIG. 13 is a perspective view of the syringe barrel with integrated handle ofFIG. 12 , with a cannula handle and cannula, with a portion of the cannula broken away; -
FIG. 14 is a plan view of a male syringe barrel similar toFIG. 6 , illustrating a screen of a first alternate embodiment of the present disclosure; -
FIG. 15 is a plan view of a male syringe barrel similar toFIG. 6 , illustrating a screen of a second alternate embodiment of the present disclosure; -
FIG. 16 is a plan view of a male syringe barrel similar toFIG. 6 , illustrating a screen of a third alternate embodiment of the present disclosure; -
FIG. 17 is a plan view of a male syringe barrel similar toFIG. 6 , illustrating a screen of a fourth alternate embodiment of the present disclosure; and -
FIG. 18 is a cross-sectional view of the screen of the male syringe barrel ofFIG. 17 , taken along lines 18-18 ofFIG. 17 . - The system of the present disclosure includes a
first syringe barrel 10 and asecond syringe barrel 12. Thefirst syringe barrel 10 includes amale engagement region 14 and thesecond syringe barrel 12 includes afemale engagement region 16. Themale engagement region 14 and thefemale engagement region 16 may each be provided with ascreen screen round openings 22. Theopenings 22 may all be of equal size, or may be of varying sizes. Each of thescreen respective syringe barrel screens openings 22. It is found that tissue sealant constituents of relatively low viscosity, such as thrombin, can be reconstituted with a lower number of pours or swooshes when being mixed between the first andsecond syringe barrels - As best illustrated in
FIGS. 2 , 4 and 6, thefirst syringe barrel 10 includes amain chamber 24 defined by acylindrical barrel wall 26, an openproximal end 28 sized to receive aplunger 30, and adistal end 32. Thedistal end 32 includes ascreen 18. The axially-extendingmale engagement region 14 includes a cylindricalinner wall 34 and a cylindricalouter wall 36, separated from one another by at least one, and preferably two,female threads 38 forming a threadedchannel 40 open at thedistal end 32 of thefirst syringe barrel 10, radially outward of thescreen 18. Theinner wall 34 andouter wall 36 of the axially-extending male connectingregion 14 come together at aneck portion 42 of thefirst syringe barrel 10. - A pair of
opposing flanges cylindrical barrel wall 26, preferably spaced a distance of approximately 0.3 inch from theproximal end 28 of thefirst syringe barrel 10. Theflanges ribs 48 on at least the surface of the flange facing thedistal end 32 of thefirst syringe barrel 10. - As best illustrated in
FIGS. 3 , 5 and 7, thesecond syringe barrel 12 includes amain chamber 50 defined by acylindrical barrel wall 52. Thecylindrical barrel wall 52 extends from an openproximal end 54 of thesecond syringe barrel 12 to aneck portion 56 near adistal end 58 of thesecond syringe barrel 12. The axially-extendingfemale engagement region 16 extends distally of theneck portion 56. Thescreen 20 extends across theneck portion 56, separating themain chamber 50 of thesecond syringe barrel 12 from an interior of thefemale engagement region 16. The exterior of an axially-extendingcylindrical wall 60 of thefemale engagement region 16 of thesecond syringe barrel 12 is provided with at least one, and preferably two,male threads 62. Themale threads 62 are of a complementary pitch to thefemale threads 38 of the threadedchannel 40 of thefirst syringe barrel 10. - A pair of
opposing flanges cylindrical barrel wall 52, preferably spaced a distance of approximately 0.3 inch from theproximal end 54 of thesecond syringe barrel 12. Theflanges ribs 68 on a side of the flange facing thedistal end 58 of thesecond syringe barrel 12. - When the
first syringe barrel 10 andsecond syringe barrel 12 are engaged with one another as illustrated inFIGS. 1 and 9 , thescreen 18 of thefirst syringe barrel 10 and thescreen 20 of thesecond syringe barrel 12 are in close proximity to one another. Preferably, when thefirst syringe barrel 10 andsecond syringe barrel 12 are engaged with one another, thescreen 18 of thefirst syringe barrel 10 and thescreen 20 of thesecond syringe barrel 12 are parallel to one another and spaced apart a distance d in a range from approximately 0.02 inch to 0.05 inch, preferably approximately 0.03 inch. It has been found that utilizing the twoscreens screens separate syringe barrels - The
female threads 38 and the leading edges of themale threads first syringe barrel 10 andsecond syringe barrel 12 are fully engaged with one another, with themale engagement region 14 seated in thefemale engagement region 16, theflanges first syringe barrel 10 are substantially aligned with theflanges second syringe barrel 12. Preferably, when fully engaged, theflanges second syringe barrel 12 are no more than 10° out of alignment with theflanges first syringe barrel 10, as illustrated by the broken lines inFIG. 8 when the threads are fully threaded and fully torqued. In a preferred embodiment, the threads have a torque applied of approximately 2 lbf-in. when fully torqued. - Each of the
first syringe barrel 10 andsecond syringe barrel 12 may include an integralannular retaining rib cylindrical barrel wall proximal end ribs plunger - In use, a given quantity of a substance to be reconstituted in powdered form, such as lyophilized thrombin, is provided in the
second syringe barrel 12 with theplunger 74 received in the openproximal end 54 of thesecond syringe barrel 12, and a predetermined volume of a diluent or reconstituting agent, such as calcium chloride solution or liquid thrombin, is provided in thefirst syringe barrel 10 with theplunger 30 received in the open proximal end of the first syringe barrel 10 (although it will be recognized that the substance to be reconstituted may instead be initially provided in thefirst syringe barrel 10, and the diluent may be provided in the second syringe barrel 12). Thescreen 20 of thesecond syringe barrel 12 retains the powder in themain chamber 50 of thesecond syringe barrel 12 while the powder is dry. Thefirst syringe barrel 10 andsecond syringe barrel 12 are then engaged with one another by inserting themale engagement region 14 of thefirst syringe barrel 10 into thefemale engagement region 16 of thesecond syringe barrel 12, with themale threads 62 extending outwardly from the axially-extendingcylindrical wall 60 of thefemale engagement region 16 received in thefemale threads 38 of the threadedchannel 40 of themale engagement region 14. - When the
first syringe barrel 10 andsecond syringe barrel 12 are fully engaged with one another, theflanges first syringe barrel 10 are preferably substantially aligned with theflanges second syringe barrel 12. In order to mix the syringe barrel contents, initially theplunger 30 of thefirst syringe barrel 10, i.e. the syringe barrel having the diluent, is pushed to force the liquid into thesecond syringe barrel 12, the solid-bearing syringe barrel. Theplunger 74 of the second syringe barrel 12 (which now also contains the diluent) is pushed to inject the mixture back across the twoscreens first syringe barrel 10. This process is repeated until the desired consistency is achieved. This is process of injecting the contents of one syringe barrel into another, then back into the first, is referred to as “swooshing”. It is found that the force necessary to mix the contents of the twosyringe barrels screens openings 22 also influences the efficiency with which the contents of the syringe barrels may be mixed. In addition, the homogeneous quality of the mixture is improved. As discussed in more detail below, alternate embodiments for thescreens openings 22 take different shapes or forms, are contemplated within the scope of the present disclosure. In the present embodiment, thescreens - Once the contents of the syringe barrels 10, 12 are fully mixed, the syringe barrels 10, 12 are preferably tilted so the reconstituted solution is poured into the
second syringe barrel 12. The syringe barrels 10, 12 are then disengaged from one another, and as illustrated inFIG. 10 , anadapter 76 having an engagement region similar to themale engagement region 14 of thefirst syringe barrel 10, is secured to thefemale engagement region 16 of thesecond syringe barrel 12. Next, theadapter 76 may be connected to a conventional cannula handle 78 andcannula 80, as illustrated inFIG. 11 . Utilizing a passageway or channel in a trocar, thecannula 80 may be introduced into the body of a patient adjacent a target tissue site. Theplunger 74 on thesecond syringe barrel 12 may then be used to force the reconstituted solution into thecannula 80 and onto the target tissue site to act as a tissue sealant. - As an alternative to connecting the
second syringe barrel 12 andadapter 76 directly to thecannula handle 78 andcannula 80, thesecond syringe barrel 12 andadapter 76 may be attached to asyringe barrel 82 with anintegrated handle 84, as illustrated inFIG. 12 . The reconstituted contents of thesecond syringe barrel 12 may then be pushed into thesyringe barrel 82 by pushing on theplunger 74 of thesecond syringe barrel 12. Thesyringe barrel 82 is preferably provided with a one-way check valve 90, as illustrated inFIG. 13 . - Once the reconstituted contents of the
second syringe barrel 12 is pushed into thesyringe barrel 82, thesyringe barrel 82 is then detached from thesecond syringe barrel 12 andadapter 76, and connected to thecannula handle 78 andcannula 80. Thesyringe barrel 82 may then be used to introduce the reconstituted solution into the cannula by pressing on thestem 86, thereby advancing theplunger 88 into thesyringe barrel 82, and thereby injecting the reconstituted solution into thecannula 80. - Depending on the length of the
cannula 80, it may be necessary to introduce additional air into thecannula 80 behind the reconstituted solution in order to advance the reconstituted solution all the way through thecannula 80 and to a target tissue site. The one-way check valve 90 permits the medical professional, after the reconstituted solution has been introduced into thecannula 80, to pull back thestem 86 and plunger 88 a second time, thereby drawing air into theempty syringe barrel 82. Thestem 86 andplunger 88 may then be advanced a second time, pushing the air into thecannula 80. This pressurizes the air in the cannula and the pressure then advances the reconstituted solution farther down the length of thecannula 80. Thestem 86 andplunger 88 may be used to repeatedly draw air into thesyringe 82 and advance the air into thecannula 80 until the desired amount of reconstituted solution is injected onto the target tissue site. - In knee surgeries and other surgical procedures where a target tissue site is readily accessible subcutaneously without a trocar, tissue sealant that has been reconstituted using the system of the present disclosure may be applied to the internal target tissue site directly from either the
syringe barrel 82 or thesecond syringe barrel 12, without the use of acannula 80. - In some instances, it has been found that portions of mesh screens 18, 20 may become clogged, thereby increasing the resistance to flow. However, enlarging the size of the openings in the mesh may detrimentally affect mixing efficiency. Balancing these considerations, alternate screen designs are also contemplated within the scope of the present disclosure. Turning to
FIGS. 14-18 , thescreens FIG. 14 , a first alternate embodiment of thescreen 20 of thesecond syringe barrel 12 may take the form of acircular opening 92 having a plurality of spaced, inwardly-directed protuberances or bumps 94. The inwardly-directed protuberances or bumps 94 may be arranged with each of fourbumps 94 disposed at 45° intervals along the interior of thecircular opening 92. - As illustrated in
FIG. 15 , a second alternate embodiment of thescreen 20 may take the form of acircular opening 96 provided with a pair of bar-like elements 98 arranged in a cross configuration. - As illustrated in
FIG. 16 , a third alternate embodiment of thescreen 20 may take the form of adisc 100 having a plurality of cantilevered wedges or flaps 102 defining slots therebetween. In this particular embodiment, fourflaps 102 are provided, defining fourslots 104 in thedisc 100. In a particularly preferred embodiment, each of theslots 104 has a length of approximately 0.377″ and a width of approximately 0.015″, yielding a cross-sectional flow area of approximately 0.011085 in2. - In
FIG. 17 , a fourth alternate embodiment of thescreen 20 is illustrated. In this embodiment, thescreen 20 takes the form of adisc 106 having eight cantilevered wedges or flaps 108, defining eightslots 110 in thedisc 106. In a particularly preferred embodiment, each of theslots 110 has a length of approximately 0.377″ and a width of approximately 0.015″, yielding a cross-sectional flow area of approximately 0.021945 in2. - It is recognized that the number and dimensions of the
slots screen 20 will impact the degree to which any retained powder in themain chamber 50 of thesecond syringe barrel 12 will break apart and mix upon initial and subsequent tilting back-and-forth of the engaged first and second syringe barrels 12. The number and dimensions of theslots main chamber 50 when thesecond syringe barrel 12 is uncapped. Thus, variations on the geometry described for these particular preferred embodiments may be made that are still considered within the scope of the present disclosure. - As illustrated in the cross-sectional view of
FIG. 18 , the cantilevered wedges or flaps 108 of the fourth alternate embodiment (and, similarly, the cantilevered wedges or flaps 102 of the third alternate embodiment) may be of a thickness that tapers from aperimeter 112 of thescreen 20 toward atip 114 of each of theflaps 108. By tapering theflaps 108 of thescreen 20, theflaps 108, which are preferably plastic, are free to bend in the direction of flow during mixing. By virtue of theflaps 108 bending in the direction of flow, theslots 110 increase in width during each pour across thescreen 20, thereby reducing the resistance to flow. - While the present invention has been described with respect to various specific embodiments, it will be understood that variations may be made that are still within the scope of the present disclosure. The appended claims are not intended to be limited to the details of the specific embodiments disclosed herein.
Claims (26)
1. A system for reconstituting and delivering solutions comprising:
a first syringe barrel having an open proximal end and a male engagement region at a distal end, the male engagement region including a first screen;
a plunger received in the open proximal end of the first syringe barrel;
a second syringe barrel having an open proximal end and a female engagement region at a distal end, the female engagement region including a second screen; and
a plunger received in the open proximal end of the second syringe barrel,
the first syringe barrel and second syringe barrel being engageable with one another by engaging the male engagement region of the first syringe barrel with the female engagement region of the second syringe barrel.
2. The system of claim 1 , wherein the first syringe barrel includes a neck portion and the male engagement region includes a cylindrical inner wall and a cylindrical outer wall, each of the cylindrical inner and outer walls axially extending in a distal direction from the neck portion and defining a threaded channel therebetween.
3. The system of claim 2 , wherein the first screen extends radially inwardly from the cylindrical inner wall.
4. The system of claim 2 , wherein the second syringe barrel includes a neck portion and the female engagement region includes an axially extending cylindrical wall including at least one male thread on an outer surface thereof.
5. The system of claim 4 , wherein the second screen extends radially inwardly from the axially extending cylindrical wall of the second syringe barrel.
6. The system of claim 1 , wherein each of the first syringe barrel and second syringe barrel includes a pair of flanges projecting radially outwardly therefrom.
7. The system of claim 6 , wherein when the first syringe barrel and second syringe barrel are fully engaged with one another, the pair of flanges projecting radially from the first syringe barrel are substantially aligned with the pair of flanges projecting radially from the second syringe barrel.
8. The system of claim 1 , wherein at least one of the first and second screens is a mesh screen.
9. The system of claim 1 , wherein at least one of the first and second screens comprises a plurality of protuberances extending radially inwardly from a circular opening.
10. The system of claim 9 , wherein the protuberances are disposed at 45° intervals around the circular opening.
11. The system of claim 1 , wherein at least one of the first and second screens comprises a pair of bar-like elements arranged in a cross configuration.
12. The system of claim 1 , wherein at least one of the first and second screens comprises at least one cantilevered wedge.
13. The system of claim 12 , wherein the at least one cantilevered wedge is of a thickness that tapers from a perimeter of the screen toward a tip of the wedge.
14. The system of claim 12 , wherein the at least one of the first and second screens includes a plurality of cantilevered wedges radially spaced from one another, with each pair of adjacent cantilevered wedges defining a slot therebetween.
15. The system of claim 1 , wherein the first and second screens are spaced apart from one another by a distance in a range of approximately 0.02 inch to about 0.05 inch when the first syringe barrel and the second syringe barrel are fully engaged with one another.
16. The system of claim 1 , further comprising an adapter engageable with the female engagement region of the second syringe barrel.
17. A method for reconstituting a powdered agent comprising:
providing a first syringe barrel including a main chamber defined by a cylindrical barrel wall, an open proximal end, and a male engagement region at a distal end, the male engagement region including a screen;
providing a second syringe barrel including a main chamber defined by a cylindrical barrel wall, an open proximal end, and a female engagement region at a distal end, the female engagement region including a screen;
depositing the powdered agent into the main chamber of one of the first syringe barrel or the second syringe barrel; inserting a plunger in the open proximal end of the first syringe barrel;
inserting a plunger in the open proximal end of the second syringe barrel;
drawing a diluent into the main chamber of one of the first syringe barrel or the second syringe barrel;
engaging the male engagement region of the first syringe barrel with the female engagement region of the second syringe barrel; and
tilting the engaged first and second syringe barrels back and forth.
18. The method of claim 17 , wherein in providing the first syringe barrel, the first syringe barrel includes a neck portion and the male engagement region includes a cylindrical inner wall and a cylindrical outer wall, each of the cylindrical inner and outer walls axially extending in a distal direction from the neck portion and defining a threaded channel therebetween and the first screen extends radially inwardly from the cylindrical inner wall.
19. The method of claim 17 , wherein in providing the second syringe barrel, the second syringe barrel includes a neck portion, the female engagement region includes an axially extending cylindrical wall including at least one male thread on an outer surface thereof, and the second screen extends radially inwardly from the axially extending cylindrical wall of the second syringe barrel.
20. The method of claim 17 , wherein in providing each of the first syringe barrel and the second syringe barrel, each of the first syringe barrel and second syringe barrel includes a pair of flanges projecting radially outwardly therefrom, and in engaging the male engagement region of the first syringe barrel with the female engagement region of the second syringe barrel, substantially aligning the pair of flanges projecting radially from the first syringe barrel with the pair of flanges projecting radially from the second syringe barrel when the first syringe barrel and the second syringe barrel are fully engaged with one another.
21. The method of claim 17 , wherein in providing the first syringe barrel and the second syringe barrel, at least one of the first and second screens is a mesh screen.
22. The method of claim 17 , wherein in providing the first syringe barrel and the second syringe barrel, at least one of the first and second screens comprises a plurality of protuberances extending radially inwardly from a circular opening.
23. The method of claim 17 , wherein in providing the first syringe barrel and the second syringe barrel, at least one of the first and second screens comprises a pair of bar-like elements arranged in a cross configuration.
24. The method of claim 17 , wherein in providing the first syringe barrel and the second syringe barrel, at least one of the first and second screens comprises a plurality of cantilevered wedges radially spaced from one another, with each pair of adjacent cantilevered wedges defining a slot therebetween.
25. The method of claim 24 , wherein in tilting the engaged first and second syringe barrels back and forth, expanding the width of the slots between each pair of adjacent cantilevered wedges.
26. The method of claim 17 , further comprising, after tilting the engaged first and second syringe barrels back and forth:
tilting the engaged first and second syringe barrels so that the mixed contents is disposed in the second syringe barrel;
disengaging the first and second syringe barrels; and
attaching an adapter to the female engagement region of the second syringe barrel.
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US14/143,387 US9220486B2 (en) | 2009-09-08 | 2013-12-30 | Reconstitution and applicator system for wound sealant product |
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CN112449606A (en) * | 2018-06-27 | 2021-03-05 | 弗罗桑医疗设备公司 | Device for mixing medical pastes |
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Also Published As
Publication number | Publication date |
---|---|
NZ597281A (en) | 2013-07-26 |
CA2766229A1 (en) | 2011-03-17 |
KR20120048581A (en) | 2012-05-15 |
WO2011031783A1 (en) | 2011-03-17 |
EP2475308A1 (en) | 2012-07-18 |
US20140114276A1 (en) | 2014-04-24 |
AU2010292341A1 (en) | 2012-01-19 |
US9220486B2 (en) | 2015-12-29 |
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Owner name: BAXTER HEALTHCARE S.A., SWITZERLAND Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHWEISS, MARK;YARDIMCI, ATIF M.;ARIAGNO, SCOTT R.;SIGNING DATES FROM 20101020 TO 20101021;REEL/FRAME:025189/0208 Owner name: BAXTER INTERNATIONAL INC., ILLINOIS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHWEISS, MARK;YARDIMCI, ATIF M.;ARIAGNO, SCOTT R.;SIGNING DATES FROM 20101020 TO 20101021;REEL/FRAME:025189/0208 |
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