SYSTEMS, DEVICES AND METHODS FOR DISPENSING BIOCOMPATIBLE REACTIVE FORMULATIONS AND CONTROLLING CROSS-LINKING OF THE REACTIVE COMPONENTS OF THE BIOCOMPATIBLE REACTIVE FORMULATIONS
20220265938 · 2022-08-25
Inventors
Cpc classification
A61M11/007
HUMAN NECESSITIES
B01F25/31331
PERFORMING OPERATIONS; TRANSPORTING
A61J1/2093
HUMAN NECESSITIES
B01F25/3131
PERFORMING OPERATIONS; TRANSPORTING
B01F2101/22
PERFORMING OPERATIONS; TRANSPORTING
A61M2206/16
HUMAN NECESSITIES
B01F25/434
PERFORMING OPERATIONS; TRANSPORTING
B05B7/0408
PERFORMING OPERATIONS; TRANSPORTING
B05B1/3436
PERFORMING OPERATIONS; TRANSPORTING
B01F35/715
PERFORMING OPERATIONS; TRANSPORTING
B01F25/4413
PERFORMING OPERATIONS; TRANSPORTING
A61M5/2448
HUMAN NECESSITIES
B05B11/0078
PERFORMING OPERATIONS; TRANSPORTING
B05C17/00553
PERFORMING OPERATIONS; TRANSPORTING
B01F33/50112
PERFORMING OPERATIONS; TRANSPORTING
B01F2101/2202
PERFORMING OPERATIONS; TRANSPORTING
B05B11/02
PERFORMING OPERATIONS; TRANSPORTING
A61M5/19
HUMAN NECESSITIES
International classification
Abstract
A system for dispensing a biocompatible reactive formulation includes a first chamber containing a first fluid having a first reactive component, a second chamber containing a second fluid having a second reactive component, and a third chamber containing a third fluid. A spray tip assembly is configured for spraying a final mixture of the first, second and third fluids. The spray tip assembly has a spray tip housing, a mixing element disposed within the spray tip housing, a mixing chamber located between the mixing element and an inner surface of the spray tip housing. The mixing element has a proximal end adjacent the proximal end of the spray tip housing and a distal end adjacent the distal end of the spray tip housing, a third fluid inlet opening at the proximal end of the mixing element, and one or more third fluid exit openings formed in the outer surface of the mixing element that are in fluid communication with the third fluid inlet opening and that extend laterally to the outer surface of the mixing element for being in fluid communication with the mixing chamber. A fluid connector is secured to the proximal end of the spray tip housing and opposes the proximal end of the mixing element. The fluid connector has first and second fluid channels in fluid communication with the mixing chamber, and a third fluid channel in fluid communication with the third fluid inlet opening of the mixing element. A pump assembly is coupled with the first, second and third chambers for simultaneously forcing the first, second and third fluids to flow through the first, second and third fluid channels of the fluid connector and into the proximal end of the spray tip housing.
Claims
1. A system for dispensing a biocompatible reactive formulation comprising: a spray tip housing having a proximal end, a distal end, an outer wall that extends from said proximal end to said distal end of said spray tip housing, and an elongated conduit surrounded by said outer wall that extends from said proximal end to said distal end of said spray tip housing; a mixing element disposed within said elongated conduit of said spray tip housing; a mixing chamber located between an outer surface of said mixing element and an inner surface of said outer wall of said spray tip housing; said mixing element including a proximal end adjacent said proximal end of said spray tip housing and a distal end adjacent said distal end of said spray tip housing, a third fluid inlet opening at said proximal end of said mixing element, one or more third fluid exit openings formed in said outer surface of said mixing element that are in fluid communication with said third fluid inlet opening, wherein said one or more third fluid exit openings extend laterally through said mixing element to said outer surface of said mixing element for being in fluid communication with said mixing chamber; a fluid connector secured to said proximal end of said spray tip housing and opposing said proximal end of said mixing element, said fluid connector including first and second fluid channels in fluid communication with said mixing chamber, and a third fluid channel in fluid communication with said third fluid inlet opening of said mixing element.
2. The system as claimed in claim 1, wherein said mixing element further comprises a third fluid conduit extending distally from said third fluid inlet opening of said mixing element toward said distal end of said mixing element for interconnecting said third fluid inlet opening and said one or more third fluid exit openings of said mixing element.
3. The system as claimed in claim 2, wherein said fluid connector has a proximal end and a distal end, and wherein said distal end of said fluid connector is disposed within said elongated conduit of said spray tip housing and opposes said proximal end of said mixing element.
4. The system as claimed in claim 3, wherein said first, second and third fluid channels of said fluid connector extend from said proximal end to said distal end of said fluid connector, and wherein said first, second and third fluid channels are isolated from one another within said fluid connector.
5. The system as claimed in claim 4, wherein said third fluid channel of said fluid connector extends through a central region of said fluid connector, and wherein said first and second fluid channels of said fluid connector extend on opposite sides of said third fluid channel.
6. The system as claimed in claim 2, wherein said one or more third fluid exit openings are located adjacent said distal end of said mixing element, and wherein said third fluid conduit of said mixing element extends to said distal end of said mixing element for being in fluid communication with said one or more third fluid exit openings.
7. The system as claimed in claim 2, wherein said one or more third fluid exit openings are located midway between said proximal and distal ends of said mixing element, and wherein said third fluid conduit of said mixing element extends to said midway location of said mixing element for being in fluid communication with said one or more third fluid exit openings.
8. The system as claimed in claim 1, wherein said one or more third fluid exit openings are located adjacent said proximal end of said mixing element, and wherein said third fluid inlet opening is in fluid communication with said one or more third fluid exit openings.
9. The system as claimed in claim 2, further comprising: said inner surface of said outer wall of said spray tip housing comprising internal threads located adjacent said proximal end of said spray tip housing; and said distal end of said fluid connector having external threads that are configured to mesh with said internal threads of said spray tip housing for securing said distal end of said fluid connector with said proximal end of said spray tip housing.
10. The system as claimed in claim 9, wherein said first fluid channel of said fluid connector is aligned with a first lateral side of said mixing chamber, said second fluid channel of said fluid connector is aligned with a second lateral side of said mixing chamber, and said third fluid channel of said fluid connector is aligned with said third fluid inlet opening and said third fluid conduit of said mixing element.
11. The system as claimed in claim 2, further comprising: a first chamber containing a first fluid having a first reactive component, wherein said first chamber is in fluid communication with said first fluid channel of said fluid connector; a second chamber containing a second fluid having a second reactive component that is reactive with said first reactive component, wherein said second chamber is in fluid communication with said second fluid channel of said fluid connector; a third chamber containing a third fluid, wherein said third chamber is in fluid communication with said third fluid channel of said fluid connector; wherein said system is configured to direct said first and second fluids in series through said respective first and second fluid channels of said fluid connector and into said mixing chamber for forming a first mixture, and wherein said system is configured to direct said third fluid in series through said third fluid channel of said fluid connector, into said third fluid inlet opening of said mixing element, through said third fluid conduit of said mixing element, and laterally through said one or more third fluid exit openings of said mixing element for entering into said mixing chamber for being added into said first mixture of said first and second fluids to form a final mixture.
12. The system as claimed in claim 11, further comprising a dispensing cap disposed within said elongated conduit of said spray tip housing and secured to said distal end of said spray tip housing for opposing said distal end of said mixing element, wherein said dispensing cap comprises a dispensing opening that is in fluid communication with a distal end of said mixing chamber for expressing said final mixture of said first, second, and third fluids.
13. A system for dispensing a biocompatible reactive formulation comprising: a first chamber containing a first fluid having a first reactive component; a second chamber containing a second fluid having a second reactive component that is reactive with said first reactive component; a third chamber containing a third fluid; a spray tip assembly that is configured for spraying a final mixture of said first, second and third fluids, said spray tip assembly comprising a spray tip housing having a proximal end, a distal end, an outer wall that extends from said proximal end to said distal end of said spray tip housing, and an elongated conduit surrounded by said outer wall that extends from said proximal end to said distal end of said spray tip housing, a mixing element disposed within said elongated conduit of said spray tip housing, a mixing chamber located between an outer surface of said mixing element and an inner surface of said outer wall of said spray tip housing, said mixing element including a proximal end adjacent said proximal end of said spray tip housing and a distal end adjacent said distal end of said spray tip housing, a third fluid inlet opening at said proximal end of said mixing element, and one or more third fluid exit openings formed in said outer surface of said mixing element that are in fluid communication with said third fluid inlet opening and that extend laterally to said outer surface of said mixing element for being in fluid communication with said mixing chamber; a fluid connector secured to said proximal end of said spray tip housing and opposing said proximal end of said mixing element, said fluid connector including first and second fluid channels in fluid communication with said mixing chamber, and a third fluid channel in fluid communication with said third fluid inlet opening of said mixing element; and a pump assembly coupled with said first, second and third chambers for simultaneously forcing said first, second and third fluids to flow through said first, second and third fluid channels of said fluid connector and into said proximal end of said spray tip housing.
14. The system as claimed in claim 13, wherein said mixing element further comprises a third fluid conduit extending distally from said third fluid inlet opening of said mixing element toward the distal end of said mixing element, and wherein said third fluid conduit is in fluid communication with said one or more third fluid exit openings for directing said third fluid from said third fluid inlet opening to said one or more third fluid exit openings.
15. The system as claimed in claim 14, further comprising: said inner surface of said outer wall of said spray tip housing comprising internal threads located adjacent said proximal end of said spray tip housing; said distal end of said fluid connector having external threads that are configured to mesh with said internal threads of said spray tip housing for securing said distal end of said fluid connector with said proximal end of said spray tip housing; wherein said first fluid channel of said fluid connector is aligned with a first lateral side of said mixing chamber, said second fluid channel of said fluid connector is aligned with a second lateral side of said mixing chamber, and said third fluid channel of said fluid connector is aligned with said third fluid inlet opening and said third fluid conduit of said mixing element.
16. A method of making a biocompatible reactive formulation comprising: using a mixing element for mixing a first fluid having a first reactive component and a second fluid having a second reactive component to form a first mixture; after forming the first mixture, adding a third fluid into said first mixture of said first and second fluids to form a final mixture; expressing said final mixture of said first mixture and said third fluid onto a surface.
17. The method as claimed in claim 16, wherein said first and second fluids are mixed together to form said first mixture adjacent a proximal end of said mixing element and said third fluid is added into said first mixture adjacent a distal end of said mixing element.
18. The method as claimed in claim 16, wherein said first and second fluids are mixed together to form said first mixture adjacent a proximal end of said mixing element and said third fluid is added into said first mixture at a location that is midway between said proximal and distal ends of said mixing element.
19. The method as claimed in claim 16, wherein said first and second fluids are mixed together to form said first mixture adjacent a proximal end of said mixing element and said third fluid is added into said first mixture adjacent said proximal end of said mixing element.
20. The method as claimed in claim 16, wherein said first fluid comprises an electrophile, said second fluid comprises a nucleophile at high pH, and said third fluid comprises a pH modifying buffer.
21. The method as claimed in claim 16, wherein said first fluid comprises an electrophile at high concentration, said second fluid comprises a nucleophile at high concentration resulting in an accelerated cross linking rate with said first fluid, and said third fluid comprises a diluent.
22. The method as claimed in claim 16, wherein said first fluid comprises Fibrinogen, said second fluid comprises Thrombin, and said third fluid comprises a diluent.
23. The method as claimed in claim 16, wherein said first and second fluids comprise additions of polyelectrolytes selected from a group consisting of alginate, heparin, hyaluronic acid, and chitosan, and said third fluid comprises polyvalent ions including Calcium.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0149] Referring to
[0150] Referring to
[0151] In one embodiment, a first piston 114 may be secured to the distal end of the first syringe plunger 108, and a second piston 116 may be secured to the distal end of the second syringe plunger 110.
[0152] In one embodiment, the applicator instrument 100 preferably includes a first syringe barrel 118 that is adapted to receive a first fluid having a first reactive component (e.g., an electrophile) of a biocompatible reactive formulation. In one embodiment, the first syringe barrel 118 is adapted to receive the first piston 114 and the first syringe plunger 108, which may be used for forcing the first fluid from the distal end of the first syringe barrel 118.
[0153] In one embodiment, the applicator instrument 100 preferably includes a second syringe barrel 120 that is adapted to receive a second fluid having a second reactive component (e.g., a nucleophile) of a biocompatible reactive formulation, whereby the first and second fluids may be mixed together to form a first mixture. In one embodiment, the second syringe barrel 120 is adapted to receive the second piston 116 and the second syringe plunger 110, which may be used for forcing the second fluid from the distal end of the second syringe barrel 120. In one embodiment, the first and second fluids have reactive components that are adapted to chemically react with one another to form a biocompatible reactive formulation that is applied to tissue or biomaterial.
[0154] In one embodiment, the applicator instrument 100 desirably includes a third syringe barrel 122 that is adapted to receive the third syringe plunger 112. In one embodiment, the third syringe barrel 122 is adapted to contain a third fluid (e.g., a pH modifying buffer; a diluent such as H.sub.2O or a buffer) that may be added into the first mixture of the first and second fluids. In one embodiment, the third plunger 112 may be used for forcing the third fluid from the distal end of the third syringe barrel, whereupon it may be added into and/or mixed with the first mixture of the first and second fluids to form a final mixture that is expressed from the distal end 104 of the applicator instrument 100.
[0155] In one embodiment, the first and second syringe barrels 118, 120 may be larger than the third syringe barrel 122. In one embodiment, the first and second syringe barrels have respective inner diameters that are the same. In one embodiment, the first and second syringe barrels 118, 120 may have respective cross-sectional diameters that are larger than the cross-sectional diameter of the third syringe barrel 122. In one embodiment, the respective first and second syringe barrels 118, 120 may be configured to hold larger volumes of fluid than the volume of fluid that may be held within the third syringe barrel 122. In one embodiment, the first and second syringe barrels may be designated as large syringe barrels and the third syringe barrel may be designated as a small syringe barrel.
[0156] In one embodiment, the first fluid within the first syringe barrel may include an electrophile (e.g., PEG-NHS). In one embodiment, the second fluid within the second syringe barrel may include a nucleophile at high pH (e.g., PEG-NH.sub.2). In one embodiment, the third fluid within the third syringe barrel may include a pH modifying buffer.
[0157] In one embodiment, the first fluid within the first syringe barrel may include an electrophile at high concentration (e.g., PEG-NHS), the second fluid within the second syringe barrel may include a nucleophile at high concentration (e.g., PEG-NH.sub.2), and the third fluid within the third syringe barrel may include a diluent (e.g., H.sub.2O or buffer).
[0158] In one embodiment, the first and second fluids may include additions of polyelectrolytes such as alginate, heparin, hyaluronic acid, and chitosan. In one embodiment, the third fluid may include polyvalent ions, such as Calcium.
[0159] In one embodiment, the first fluid comprises Fibrinogen, the second fluid comprises Thrombin, and the third fluid comprises a diluent, such as H.sub.2O.
[0160] In one embodiment, the applicator instrument 100 preferably includes a fluid manifold 124 that is located downstream from the distal ends of the first, second and third syringe barrels 118, 120, 122. In one embodiment, the fluid manifold 124 preferably includes a first connector 126 adapted to receive a distal end of the first syringe barrel 118, a second connector 128 adapted to receive a distal end of the second syringe barrel 120, and a third connector 130 adapted to receive a distal end of the third syringe barrel 122.
[0161] In one embodiment, the first connector 126 of the fluid manifold 124 is preferably in fluid communication with the first syringe barrel 118. In one embodiment, a first component of a biocompatible reactive formulation (e.g., a first fluid containing a first reactive component) that is pre-loaded into the first syringe barrel 118 may be forced to flow into the first connector 126 of the fluid manifold 124, such as by depressing the first syringe plunger 108.
[0162] In one embodiment, the second connector 128 of the fluid manifold 124 is preferably in fluid communication with the second syringe barrel 120. In one embodiment, a second component of a biocompatible reactive formulation (e.g., a second fluid containing a second reactive component that reacts with the first reactive component) that is pre-loaded into the second syringe barrel 120 may be forced to flow into the second connector 128 of the fluid manifold 124, such as by depressing the second syringe plunger 110.
[0163] In one embodiment, the third connector 130 of the fluid manifold 124 is preferably in fluid communication with the third syringe barrel 122. In one embodiment, a third component of a biocompatible reactive formulation that is pre-loaded into the third syringe barrel 122 (e.g., a pH modifying buffer; a diluent such as H.sub.2O or a buffer) may be forced to flow into the third connector 130 of the fluid manifold 124, such as by depressing the third syringe plunger 110.
[0164] In one embodiment, proximal ends of the first, second, and third syringe plungers 108, 110, and 112 may be coupled together so that they may be depressed simultaneously. In one embodiment, the proximal ends of the three syringe plungers 108, 110, and 112 may be connected with the plunger head 106, which may be forced to move in the distal direction DIR1 (
[0165] In one embodiment, the applicator instrument 100 preferably includes a connecting nut 132 that may be utilized for securing a distal end of the third syringe barrel 122 with the third connector 130 of the fluid manifold 124.
[0166] In one embodiment, O-ring retainers 134 and O-rings 136 are preferably utilized for forming fluid-tight connections between the distal ends of the three syringe barrels 118, 120, 122 and the respective connectors 126, 128, 130 of the fluid manifold 124.
[0167] In one embodiment, the applicator instrument 100 preferably includes a syringe barrel support frame 138 that is adapted to receive and hold the first, second and third syringe barrels 118, 120, and 122. The syringe barrel support frame 138 desirably holds the syringe barrels 118, 120, 122 together for stabilizing the syringe barrels and enhancing the structural integrity of the applicator instrument 100.
[0168] In one embodiment, the syringe barrel support frame 138 preferably has a distal end with a distal projection 140 having external threads, which are adapted to mesh with internal threads (not shown) of the connecting nut 132 for securing the distal end of the syringe barrel support frame 138 to the connecting nut 132. Thus, in one embodiment, the connecting nut 132 may be utilized for securing both the distal projection 140 of the syringe barrel support frame 138 and the distal end of the third syringe barrel 122 to the second connector 130 of the fluid manifold 124.
[0169] Referring to
[0170] In one embodiment, the distal end of the applicator instrument 100 preferably includes a spray tip assembly 125 that is used for spraying a final mixture of a biocompatible reactive formulation. In one embodiment, the spray tip assembly 125 desirably includes an O-ring 156 that is adapted to be assembled with the fluid connector 154, a mixing element 158 that is adapted to be disposed inside a spray tip housing 160, and a dispensing cap 162 that is adapted to be secured to the distal end of the spray tip housing 160. In one embodiment, the O-ring 156 preferably forms a fluid-tight seal between the fluid connector 154 and an inner surface of the spray tip housing 160. In one embodiment, an assembly of the fluid connector 154, the O-ring 156, the mixing element 158, the spray tip housing 160, and the dispensing cap 162 may be referred to as the spray tip assembly 125.
[0171] In one embodiment, the first and second fluid components supplied via the respective first and second fluid tubes 146 and 148 may be mixed together within a mixing chamber located inside the spray tip housing 160 to form a first mixture. In one embodiment, the third fluid component supplied via the third fluid tube 150 may be added into the first mixture to form a final mixture. In one embodiment, the third component may be added into the first mixture at a selected location between the proximal end and the distal end of the spray tip housing 160.
[0172] In one embodiment, the first and second fluids may be mixed together adjacent the proximal end of the mixing element 158 to form a first mixture and the third fluid may be added to the first mixture adjacent the proximal end of the mixing element 158 to form a final mixture that is expressed from the distal end of the spray tip housing 160.
[0173] In one embodiment, the first and second fluids may be mixed together adjacent the proximal end of the mixing element 158 to form a first mixture and the third fluid may be added to the first mixture at a midsection of the mixing element 158 to form a final mixture that is expressed from the distal end of the spray tip housing 160.
[0174] In one embodiment, the first and second fluids may be mixed together adjacent the proximal end of the mixing element 158 to form a first mixture and the third fluid may be added to the first mixture adjacent the distal end of the mixing element 158 to form a final mixture that is expressed from the distal end of the spray tip housing 160.
[0175] In one embodiment, the final mixture of the three components may be expressed (e.g., sprayed) via a dispensing opening in the dispensing cap 162.
[0176] Referring to
[0177] In one embodiment, the applicator instrument 100 desirably includes the first fluid tube 146 that is in fluid communication with the distal end of the first syringe barrel 118, the second fluid tube 148 that is in fluid communication with the distal end of the second syringe barrel 120, and the third fluid tube 150 is in fluid communication with the distal end of the third syringe barrel 122. The distal ends of the three fluid tubes 146, 148, and 150 preferably pass through the fluid tube channel 152 of the upper and lower fluid tube enclosures 142, 144 (
[0178] In one embodiment, as the plunger head 106 (
[0179] Referring to
[0180] In one embodiment, the proximal end 164 of the syringe barrel support frame 138 preferably includes syringe barrel securing flanges 168A, 168B that oppose one another and that are adapted to engage flanges located at the proximal ends of the respective first, second, and third syringe barrels 118, 120, 122 (
[0181] In one embodiment, the syringe barrel support frame 138 preferably includes a first set of C-shaped flanges 170A, 170B that are adapted to engage an outer wall of the first syringe barrel 118 (
[0182] Referring to
[0183] In one embodiment, the central openings 182, 184, 186 of the respective first, second and third connectors 126, 128, and 130 preferably extend to the distal end 180 of the fluid manifold 124. In one embodiment, proximal ends of the first, second and third fluid tubes 146, 148, 150 (
[0184] Referring to
[0185] Referring to
[0186] Referring to
[0187] In one embodiment, after the proximal ends of the respective syringe plungers 108, 110, 112 (
[0188] Referring to
[0189] In one embodiment, the distal ends of the respective upper and lower fluid tube enclosures 142, 144 preferably includes the fluid tube channel 152 that is adapted to guide the distal ends of the first, second and third fluid tubes 146, 148, 150 (
[0190] Referring to
[0191] Referring to
[0192] In one embodiment, the first syringe plunger 108 preferably includes a proximal end 236 having a thumb engaging flange 238 and a distal end 240 that is adapted to be coupled with a first piston 114 (
[0193] In one embodiment, the applicator instrument preferably includes the second syringe barrel 120 and the second syringe plunger 110 (
[0194] Referring to
[0195] In one embodiment, the third syringe plunger 112 preferably includes a proximal end 252 having a thumb engaging flange 254 that may be engaged for depressing the third syringe plunger 112 toward the distal end 246 of the third syringe barrel 122. In one embodiment, the third syringe plunger 112 preferably includes a distal end 256 that is adapted to be inserted into the central opening 250 of the third syringe barrel 122. In one embodiment, the third syringe plunger 112 may be depressed in a distal direction DIR1 (
[0196] Referring to
[0197] Referring to
[0198] In one embodiment, the distal end 230B of the second syringe barrel 120 is inserted into the third fluid inlet opening of the second connector 128 of the fluid dispensing manifold 124. A second O-ring retainer 134B and a second O-ring 136B are utilized for forming a fluid-tight coupling between the distal end 230B of the second syringe barrel 120 and the second connector 128 of the fluid manifold 124.
[0199] In one embodiment, the distal end 230C of the third syringe barrel 122 is inserted into the third fluid inlet opening of the third connector 130 of the fluid dispensing manifold 124. A third O-ring retainer 134C and a third O-ring 136C are utilized for forming a water-tight coupling between the distal end 230C of the third syringe barrel 122 and the third connector 130 of the fluid manifold 124.
[0200] In one embodiment, the first fluid dispensing opening 232A located at the distal end 230A of the first syringe barrel 118 is preferably in fluid communication with the first fluid tube 146 for directing the first fluid of a mixture from the first syringe barrel 118 into the first fluid tube 146.
[0201] In one embodiment, the second fluid dispensing opening 232B located at the distal end 230B of the second syringe barrel 120 is preferably in fluid communication with the second fluid tube 148 for directing the second fluid of a mixture from the second syringe barrel 120 into the second fluid tube 148.
[0202] In one embodiment, the third fluid dispensing opening 232C located at the distal end 230C of the third syringe barrel 122 is preferably in fluid communication with the third fluid tube 150 for directing the third fluid of the mixture from the third syringe barrel 122 into the third fluid tube 150.
[0203] Referring to
[0204] Referring to
[0205] Referring to
[0206] Referring to
[0207] Referring to
[0208] Referring to
[0209] Referring to
[0210] Referring to
[0211] Referring to
[0212] Referring to
[0213] Referring to
[0214] In one embodiment, the dispensing cap 162 may have one or more of the structural features of the dispensing caps disclosed is commonly assigned U.S. patent application Ser. No. 16/593,783, filed on Oct. 4, 2019, the disclosure of which is hereby incorporated by reference herein.
[0215] In one embodiment, the dispensing cap 162 may have one or more of the structural features of the orifice cups disclosed is commonly assigned U.S. patent application Ser. No. 16/593,799, filed on Oct. 4, 2019, the disclosure of which is hereby incorporated by reference herein.
[0216] Referring to
[0217] In one embodiment, the first fluid having the first reactive component (e.g., Fibrinogen) and the second fluid having the second reactive component (e.g., Thrombin) are mixed together within the mixing chamber of the spray tip assembly 125 to form a first mixture, and then the third fluid (e.g., a diluent or pH modifying buffer) is added to the first mixture within the mixing chamber to form a final mixture that is expressed (e.g., sprayed) from the dispensing opening of the dispensing cap 162.
[0218] In one embodiment, the mixing chamber is an elongated mixing chamber that is located inside the spray tip housing 160. The elongated mixing chamber may have an annular shape. In one embodiment, the spray tip housing 160 has a proximal end for receiving the respective first, second, and third fluids and a distal end that receives the dispensing cap 162.
[0219] Referring to
[0220] In one embodiment, the spray tip assembly 125 may utilize a first mixing element 158A having laterally extending third fluid exit openings 284A that are located adjacent the distal end 280A of the mixing element 158A. In this embodiment, the first and second fluids are first mixed together within a mixing chamber at the proximal end of the first mixing element 158A to form a first mixture, and, after the first mixture flows downstream through the mixing chamber toward the distal end of the mixing element 158A, the third fluid is added to the first mixture, via the third fluid exit openings 284A, adjacent the distal end of the first mixing element 158A.
[0221] In one embodiment, the spray tip assembly 125 may utilize a second mixing element 158B having laterally extending third fluid exit openings 284B that are located midway between the proximal end 278B and the distal end 280B of the second mixing element. In this embodiment, the first and second fluids are mixed together within the mixing chamber at the proximal end of the second mixing element 158B to form a first mixture, and, as the first mixture flows downstream through the mixing chamber toward the distal end of the mixing element 158B, the third fluid is added to the first mixture, via the third fluid exit openings 284B, at a location that is midway between the proximal end and the distal end of the second mixing element 158B.
[0222] In one embodiment, the spray tip assembly 125 may utilize a third mixing element 158C having laterally extending third fluid exit openings 284C that are located adjacent the proximal end 278C of the mixing element. In this embodiment, the first and second fluids are mixed together within the mixing chamber at the proximal end of the third mixing element 158C to form a first mixture, and the third fluid is also added to the first mixture at the proximal end of the third mixing element 158C, via the third fluid exit openings 284C, to form a final mixture. The final mixture then travels the length of the mixing element for further mixing until it is dispensed via the dispensing opening of the dispensing cap 162.
[0223] In other embodiments, the third fluid exit openings may be positioned at any location along the length of a mixing element to further modify and control how reactive components react with one another. Thus, an infinite number of different types of reactions may be attained by modifying the structure of the mixing elements.
[0224] In one embodiment, a system may include a kit having a first spray tip assembly that has the first mixing element 158A, a second spray tip assembly that has the second mixing element 158B, and a third spray tip assembly that has the third mixing element 158C, whereby only one of the three spray tip assemblies is secured to the distal end of the applicator instrument at any one time. Thus, an operator may modify the characteristics of a biocompatible reactive formulation (i.e., by controlling how, when and/or where the first and second reactive components react with one another) that is dispensed from the applicator instrument by changing the spray tip assembly that is secured to the distal end of the applicator instrument. In one embodiment, a first spray tip assembly may be disconnected from a fluid connector and replaced by a second spray tip assembly that is secured to the fluid connector for changing how the three fluids are mixed together within the spray tip housing.
[0225] Referring to
[0226] Referring to
[0227] Referring to
[0228] In one embodiment, after the third fluid exits the third fluid channel 276 of the fluid connector 154, the third fluid preferably travels downstream through the third fluid inlet opening 314A and the third fluid conduit 316A, whereupon the third fluid is directed laterally through the third fluid exit openings 284A and into the annular mixing space 285 for being added into the first mixture of the first and second fluids. In the embodiment shown in
[0229] Referring to
[0230] Referring to
[0231] Referring to
[0232] In one embodiment, when the syringe plungers are depressed, the first fluid is preferably dispensed from the first fluid channel 272 of the fluid connector 154 and the second fluid is preferably dispensed from the second fluid channel 274 of the fluid connector 154, whereupon the first and second fluids are mixed together within the annular mixing space 285 that surrounds the second mixing element 158B, thereby forming a first mixture. As the first and second fluids travel downstream toward the distal end 290 (
[0233] In one embodiment, the third fluid channel 276 located at the distal end of the fluid connector 154 is preferably aligned with the third fluid inlet opening 314B and the third fluid conduit 316B of the second mixing element 158B. In one embodiment, the third fluid is preferably dispensed from the third fluid channel 276 and into the third fluid inlet opening 314B, whereupon the third fluid is directed downstream into the third fluid conduit 316B of the second mixing element 158B. The third fluid preferably travels downstream to a midway location of the second mixing element 158B, whereupon the third fluid is directed laterally through the third fluid exit openings 284B and into the annular mixing space 285 that surrounds the outer perimeter of the second mixing element 158B for being added into the first mixture of the first and second fluids to form a final mixture.
[0234] In the particular embodiment shown in
[0235] Referring to
[0236] Referring to
[0237] In one embodiment, when syringe plungers are depressed, the first fluid is preferably dispensed from the first fluid channel 272 of the fluid connector 154 and the second fluid is preferably dispensed from the second fluid channel 274 of the fluid connector, whereupon the first and second fluids are mixed together within an annular mixing space 285 located between the outer surface of the third mixing element 158C and an inner surface of the spray tip housing 160 to form a first mixture.
[0238] In one embodiment, the third fluid channel 276, located at the distal end of the fluid connector 154, is preferably aligned with the third fluid inlet opening 314C of the third mixing element 158C. In one embodiment, the third fluid is preferably dispensed from the third fluid channel 276 of the fluid connector 154 and into the third fluid inlet opening 314C, whereupon the third fluid is directed laterally through the third fluid exit openings 284C located adjacent the proximal end 278C of the third mixing element 158C. The third fluid is preferably directed through the third fluid exit openings 284C and into the annular mixing space 285 that surrounds the outer perimeter of the third mixing element 158C for being added into the first mixture of the first and second fluids, which forms a final mixture.
[0239] In the particular embodiment shown in
[0240] Referring to
[0241] In one embodiment, the applicator instrument 100′ preferably includes three syringe plungers 108′, 110′, and 112′ that have the same size, shape and dimension. In one embodiment, the applicator instrument 100′ preferably includes three syringe barrels 118′, 120′, and 122′ that have the same size, shape, configuration, and dimension.
[0242] In one embodiment, the applicator instrument 100′ preferably includes the first syringe barrel 118′ that is adapted to contain a first reactive fluid of a multiple component tissue adhesive. In one embodiment, the first syringe barrel 118′ is adapted to receive the first syringe plunger 108′, which may be used for forcing the first reactive fluid from the distal end of the first syringe barrel 118′.
[0243] In one embodiment, the applicator instrument 100 preferably includes the second syringe barrel 120′ that is adapted to contain a second reactive fluid of the multiple component tissue adhesive. In one embodiment, the second syringe barrel 120′ is adapted to receive the second syringe plunger 110′, which may be used for forcing the second reactive fluid from the distal end of the second syringe barrel 120′. The first and second reactive fluids may be mixed together to form a first mixture. In one embodiment, the first and second reactive fluids may be adapted for chemically reacting with one another to form a biocompatible reactive formulation, such as a tissue adhesive or a tissue sealant.
[0244] In one embodiment, the applicator instrument 100 desirably includes the third syringe barrel 122′, which is adapted to receive the third syringe plunger 112′. In one embodiment, the third syringe barrel 122′ is adapted to contain a third fluid component (e.g., a neutralizing buffer; a diluent, such as H.sub.2O). In one embodiment, the third syringe plunger 112′ may be depressed for forcing the third fluid component from the distal end of the third syringe barrel 122′, whereupon the third fluid may be added into and/or mixed with the first mixture of the first and second reactive fluids.
[0245] In one embodiment, proximal ends of the syringe plungers 108′, 110′, and 112′ are preferably secured to a plunger head 106′, which may be depressed in the distal direction DIR1 for simultaneously moving the syringe plungers in the distal direction DIR1 to simultaneously dispense the first, second and third fluids from the respective first, second and third syringe barrels 118′, 120′, and 122′.
[0246] In one embodiment, the first, second and third syringe barrels 118′, 120′, and 122′ are the same size and may have respective cross-sectional diameters that are the same size. In one embodiment, the respective first, second, and third syringe barrels 118′, 120′, and 122′ are configured to hold an equal volume of fluid. Thus, the volume of the first fluid held in the first syringe barrel 118′ may equal the volume of the second fluid held in the second syringe barrel 120′, which, in turn, may be equal to the volume of the third fluid held in the third syringe barrel 122′.
[0247] In one embodiment, the applicator instrument 100′ preferably includes a fluid manifold 124′ that is located downstream from the distal ends of the first, second and third syringe barrels 118′, 120′, 122′. In one embodiment, the fluid manifold 124′ preferably includes a first connector 126′ adapted to receive a distal end of the first syringe barrel 118′, a second connector 128′ adapted to receive a distal end of the second syringe barrel 120′, and a third connector 130′ adapted to receive a distal end of the third syringe barrel 122′.
[0248] In one embodiment, the first connector 126′ of the fluid manifold 124′ is preferably in fluid communication with the first syringe barrel 118′. In one embodiment, a first component of a multiple component adhesive that is pre-loaded into the first syringe barrel 118′ may be forced to flow into the first connector 126′ of the fluid manifold 124′, such as by depressing the first syringe plunger 108′.
[0249] In one embodiment, the second connector 128′ of the fluid manifold 124′ is preferably in fluid communication with the second syringe barrel 120′. In one embodiment, a second component of a multiple component adhesive that is pre-loaded into the second syringe barrel 120′ may be forced to flow into the second connector 128′ of the fluid manifold 124′, such as by depressing the second syringe plunger 110′.
[0250] In one embodiment, the third connector 130′ of the fluid manifold 124′ is preferably in fluid communication with the third syringe barrel 122′. In one embodiment, a third component of a multiple component adhesive that is pre-loaded into the third syringe barrel 122′ may be forced to flow into the third connector 130′ of the fluid manifold 124′, such as by depressing the third syringe plunger 110′.
[0251] In one embodiment, the applicator instrument 100′ preferably includes a syringe barrel support frame 138′ that is adapted to receive and hold the first, second and third syringe barrels 118′, 120′, and 122′. The syringe barrel support frame 138′ desirably holds the syringe barrels 118′, 120′, 122′ together for stabilizing the syringe barrels and enhancing the structural integrity and consistent performance of the applicator instrument 100.
[0252] In one embodiment, the syringe barrel support frame 138 preferably has a distal end with a distal projection 140′ having internal threads, which are adapted to mesh with external threads of a connecting nut 132′ for securing the distal end of the syringe barrel support frame 138′ to the connecting nut 132′. In one embodiment, the connecting nut 132′ may also be utilized for securing both the distal projection 140′ of the syringe barrel support frame 138′ and the distal end of the third syringe barrel 122′ to the second connector 130′ of the fluid manifold 124′.
[0253] Referring to
[0254] In one embodiment, the distal end 230B′ of the second syringe barrel 120′ is inserted into the third fluid inlet opening of the second connector 128′ of the fluid dispensing manifold 124′. A second O-ring retainer 134B′ and a second O-ring 136B′ are utilized for forming a fluid-tight coupling between the distal end of the second syringe barrel 120′ and the second connector 128′ of the fluid manifold 124′.
[0255] In one embodiment, the distal end 230C′ of the third syringe barrel 122′ is inserted into the third fluid inlet opening of the third connector 130′ of the fluid dispensing manifold 124′. A third O-ring retainer 134C′ and a third O-ring 136C′ are utilized for forming a water-tight coupling between the distal end of the third syringe barrel 122′ and the third connector 130′ of the fluid manifold 124′.
[0256] In one embodiment, the first fluid dispensing opening 232A′ located at the distal end of the first syringe barrel 118′ is preferably in fluid communication with the first fluid tube 146′ for directing the first fluid of a mixture from the first syringe barrel 118′ into the first fluid tube 146′.
[0257] In one embodiment, the second fluid dispensing opening 248B′ located at the distal end 230B′ of the second syringe barrel 120′ is preferably in fluid communication with the second fluid tube 148′ for directing the second fluid of a mixture from the second syringe barrel 120′ into the second fluid tube 148′.
[0258] In one embodiment, the third dispensing opening 248C′ at the distal end 230C′ of the third syringe barrel 122′ is preferably in fluid communication with the third fluid tube 150′ for directing the third fluid of the mixture from the third syringe barrel 122′ into the third fluid tube 150′.
[0259] In one embodiment, the distal end 104′ of the applicator instrument 100′ preferably includes the spray tip assembly 125′, which is secured to the distal ends of the respective upper and lower fluid tube enclosures 142′, 144′. In one embodiment, the spray tip assembly 125′ preferably includes the fluid connector 154′ having a distal end that is secured to a proximal end of the spray tip housing 160′. An O-ring 156′ forms a fluid-tight seal between the fluid connector 154′ and the spray tip housing 160′ A mixing element 158′ is disposed inside the spray tip housing 160′. A dispensing cap 162′ is preferably assembled within an opening provided at the distal end of the spray tip housing 160′.
[0260] Referring to
[0261] In one embodiment, proximal ends of the first, second and third syringe plungers 108″, 110″ and 112″ are desirably secured to the plunger head 106″. The plunger head 106″ may be pushed in the distal direction DIR1 for forcing the pistons 114″, 116″ and 117″ toward the distal ends of the respective syringe barrels 118″, 120″, and 122″ to simultaneously force the first, second and third fluids from the distal ends of the syringe barrels.
[0262] In one embodiment, when the plunger head 106″ is depressed, the first fluid in the first syringe barrel 118″ flows downstream through the first fluid tube 146″ and into the spray tip assembly 125″, and the second fluid in the second syringe barrel 120″ flows downstream through the second fluid tube 148″ and into the spray tip assembly 125″ for being mixed with the first fluid to form a first mixture. Simultaneously, the third fluid in the third syringe barrel 122″ flows downstream through the third fluid tube 150″ and into the spray tip assembly 125″ for being added into the first mixture of the first and second fluids. The third fluid is preferably added into the first mixture of the first and second fluids at a location that is downstream of the location where the first and second fluids are first mixed together within the spray tip assembly 125″. The location where the third fluid tube 150″ enters the spray tip assembly 125″ may be modified for changing how the first and second reactive components react with one another.
[0263] While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.