TWO-COMPONENT REACTIVE SURGICAL SEALANT

Field of the Disclosure

[0001] This disclosure relates generally to systems for applying a sealant to a work surface and, more particularly, to a device for mixing and applying a multi-component composition, such as a surgical tissue sealant made of two fluid components, to biological tissue employing structure that facilitates controlled spray application of the sealant.

Brief Summary of the Disclosure

[0002] In conventional applicators for mixing and applying a multi-component composition to a biological tissue, two components need to be mixed to achieve the intended composition often just before application of the composition. However, just before the components come into contact they often react or at least begin to react, forming a very viscous fibrin material that dramatically increases clogging in the applicator. The conventional devices and applicators would typically either form sprays in which the component fluids come into contact immediately before exiting a spray tip of the applicator or have replaceable tips.

[0003] The device of the present disclosure provides passageways so that only a portion of two fluid components come into contact and mix as they travel through a spray tip of the applicator. Then all three streams, the mixed stream and the separated streams, are each directed into separate feeder channels that bring all the fluid streams together at the last possible moment in a spin chamber.

[0004] More specifically, the device of the present disclosure is particularly useful for mixing and applying multi-component compositions to a work surface, such as two- component surgical sealants, while avoiding clogs, preventing cross-contamination of the components until a point of intended mixing at a location within the apparatus in close proximity to an application opening in a tip cap, decreasing pressure drop along the apparatus and system to facilitate fluid delivery, and increasing efficiency of mixing of the components. It will be appreciated that not all of these advantages need be achieved by a mixing and dispensing device made in accordance with the present disclosure.

[0005] The mixing and dispensing device maintains a physical boundary between each component of a two-component composition until it is suitable to initiate contact, which is particularly desirable for components that quickly react upon exposure to one another. In the case of multi-part surgical sealants, the components, such as a buffer (e.g., a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution) and a reconstituted mix of two synthetic polyethylene glycols (PEG's), begin to react with one another almost immediately upon exposure to each other, so it is desirable to avoid substantial premature mixing, i.e., cross-contamination or "cross-talk" of the components, while they are within the mixing and dispensing device, thereby leading to clogging. It is also desirable to avoid inadequate mixing of components, as failure to adequately mix the components may yield a poor mixture and cause clogging, for example. Further, premixing a desired proportion of each of the components before all of the components are mixed together just prior to application results in an improved mixture.

Brief Description of the Several Views of the Drawing

[0006] Fig. 1 is an exploded perspective view of a spray tip sub-assembly, with a broken away portion of a malleable cannula and an alternate distal end of a cannula;

[0007] Fig. 2 is an exploded rear view of a tip insert of a spray tip sub-assembly of Fig. 1, wherein the tip insert has a substantially octagonal shape;

[0008] Fig. 3 is a perspective view of the spray tip sub-assembly of Fig. 1, illustrating the tip insert within a tip cap of the spray tip sub-assembly and a mixed component being released from a delivery opening at a distal end of the tip cap, the mixed component illustrated by lines having both solid and hollow bubbles, the solid bubbles representing a first mixing component and the hollow bubbles representing a second mixing component;

[0009] Fig. 4 is a cross-sectional view of the spray tip sub-assembly taken along lines 4-4 of Fig. 3, illustrating the tip insert keeping first and second mixing components from mixing prematurely when fluid passes from the cannula and into the tip insert of the spray tip subassembly;

[0010] Fig. 5 is another cross-sectional view of the spray tip sub-assembly taken along lines 5-5 of Fig. 3, illustrating the angled indentations directing fluid from the fluid carrying channels of the cannula toward a space between the walls of the tip insert and the tip cap;

[0011] Fig. 6 is another cross-sectional view of the spray tip sub-assembly taken along lines 6-6 of Fig. 3, illustrating the fluid even further directed from the fluid carrying channels of the cannula into the tip insert and tip cap;

[0012] Fig. 7 is another cross-sectional view of the spray tip sub-assembly taken along lines 7-7 of Fig. 3, illustrating the fluid directed to feeder channels of the tip cap, some of which has been already mixed in one feeder, wherein other fluids will not be mixed until after the feeder channels deliver the fluids to the spinner region;

[0013] Fig. 8 is a plan view of the cannula of Fig. 1;

[0014] Fig. 9 is a cross-sectional view of the cannula taken along the lines 9-9 of Fig. 8;

[0015] Fig. 10 is a cross-sectional view of the cannula taken along the lines 10-lOof Fig. 8;

[0016] Fig. 11 is a front plan view of a tip insert of the spray tip sub-assembly illustrated in Fig. 1;

[0017] Fig. 12 is a perspective view of the tip insert of Fig. 11;

[0018] Fig. 13 is a bottom plan view of the tip insert of Fig. 11 ;

[0019] Fig. 14 is a top plan view of the tip insert of Fig. 11 ; [0020] Fig. 15 is a perspective view of a tip cap of the spray tip sub-assembly illustrated in Fig. 1;

[0021] Fig. 16 is a top plan view of the tip cap of Fig. 15;

[0022] Fig. 17 is a cross-sectional view, taken along lines 17-17 of Fig. 16, of the tip cap of Fig. 11;

[0023] Fig. 18 is a top plan view of a proximal hub of a luer hub sub-assembly of the present disclosure;

[0024] Fig. 19 is a cross-sectional view of the proximal hub of Fig. 18 taken along the lines 19-19 of Fig. 18;

[0025] Fig. 20 is a perspective view of the distal hub of a luer hub sub-assembly of the present disclosure;

[0026] Fig. 21 is a top view of the distal hub of Fig. 20;

[0027] Fig. 22 is a cross-sectional view taken along lines 22-22 of Fig. 21;

[0028] Fig. 23 is an enlarged view of the region indicated by the circle designated "Fig.

23" in Fig. 22;

[0029] Fig. 24 is an enlarged view of the region indicated by the circle designated "Fig. 24" in Fig. 21; and

[0030] Fig. 25 is a perspective view of a syringe assembly that may be used with the luer hub sub-assembly and cannulae referenced herein.

Detailed Description of the Preferred Embodiments

[0031] Now referring to Figs. 1-7, a spray tip sub-assembly 318 of the present disclosure is illustrated. More specifically, Fig. 1 illustrates an exploded perspective view of the spray tip sub-assembly 318 of Fig. 1, with a broken-away portion of a malleable cannula 316. The spray tip sub-assembly 318 of this embodiment includes a tip insert 348 having a

substantially octagonal distal portion, with three substantially flat side walls 377a, 377b, and 377c, and five concave or rounded side walls 377d, 377e, 377f, 377g, 377h. A tip cap 342 of the spray tip sub-assembly 318 includes a cylindrical wall 373 and an end wall 375.

[0032] The malleable cannula 316 includes four lumens and is preferably a malleable cannula 316 extruded from a soft thermoplastic polyurethane elastomer, such as The Dow Chemical Company's Pellethane TM. Two of the lumens are fluid carrying lumens 330, 332, each of which may also be placed into fluid communication with the respective fluid path hole of the distal hub of the luer-hub subassembly 322 of Figs. 18-20. The malleable cannula 316 also includes a third lumen 334, which may receive a wire resulting in improved malleability of the cannula 316, and a fourth lumen 362, which may be employed to accommodate, for example, suction, pressurized gas, flushing solution, a light, a heat source, or a fiber optic camera.

[0033] As illustrated in Fig. 1, a distal end region 366 of the malleable cannula 316 includes a pair of elongate notches where portions of the malleable cannula 316 are shaved or otherwise cut back to expose semi-cylindrical channel regions 330a and 332a, each of which is an extension of a respective one of the fluid carrying lumens 330, 332. The notches each extend axially along the malleable cannula 316, from a distal end wall 400 of the malleable cannula 316 to a stop wall 402 spaced axially inwardly (i.e., proximally) of the distal end wall 400. The semi-cylindrical channel regions 330a, 332a are each bounded along their lateral edges by alignment ledges 404, 406, 408, 410 (also illustrated in Figs. 4 and 5) extending to the outer perimeter of the malleable cannula 316. The third and fourth lumens 334, 362 run between the alignment ledges 404, 408, and 406, 410, with the remaining portion of the malleable cannula 316 that surrounds the third and fourth lumens 334, 362 along the notches, and defining the semi-cylindrical channel regions 366a, 366b, forming a male projection 370 of the malleable cannula 316. The male projection 370 is received in a female mating port 379 (as illustrated in Fig. 2) of the tip insert 348. [0034] The tip insert 348 includes structural features to direct fluid from the fluid carrying lumens 330, 332 of the malleable cannula 316 toward space between the tip insert 348 and the tip cap 342 when the tip insert 348 is secured to the distal end section 366 of the malleable cannula 316. As indicated in Fig. 2, these structural features include a pair of fluid path archways 381, 383, each of which align with a portion of a respective one of the semi- cylindrical channel regions 330a, 332a (Fig. 1) of the cannula 316. .

[0035] Figs. 11-14 illustrate the additional structural features of the tip insert 348. For example, the tip insert 348 also includes a pair of substantially Quonset-shaped wedges 412, 414, both of which are illustrated in Fig. 11, that are axially aligned with a respective one of the fluid path archways 381, 383. As further illustrated in Fig. 11, each substantially

Quonset-shaped wedge 412, 414 has a proximal surface 416 that includes fillets 417 or curved or rounded edges. When the male projection 370 of the malleable cannula 316 is engaged with the tip insert 348, each of these substantially Quonset-shaped wedges 412, 414 occupies a portion of a respective one of the semi-cylindrical channel regions 330a, 332a closer to the end wall 375 of the tip cap 342. While in this position, the fillets 417 of the proximal surfaces 416 of the Quonset-shaped wedges 412, 414 divert fluid from the fluid- carrying lumens through the fluid path archways 381, 383, into flow paths defined between crescent- shaped channels 376, 378 (Fig. 14) running axially along an exterior of the tip insert 348, and an inner surface 373a of the cylindrical wall 373 of the tip cap 342. The fillets 417 of the proximal surfaces 416 further help direct the male projection 370 of the malleable cannula 316 into engagement with the female mating port 379 of the tip insert 348 during assembly.

[0036] As illustrated in Figs. 15, 16, and 17, the tip cap 342 may be provided with an inwardly-directed registration dimple or depression 420 in a region of the tip cap 342 where the cylindrical wall 373 of the tip cap 342 meets the end wall 375 of the tip cap 342. As further illustrated in Fig. 17, a corresponding interior region of the tip cap 342 has an inwardly-directed registration key 422. A complementary alignment keyway notch 424 (see, e.g., Figs. 11 and 12) is provided in a distal end of the tip insert 348, which receives the inwardly-directed registration key 422 when the tip insert 348 is received in the tip cap 342. Engagement of the inwardly-directed registration key 422 of the tip cap 342 with the alignment notch 424 (Figs. 11 and 12) of the tip insert 348 assures proper alignment between the tip cap 342 and the tip insert 348.

[0037] As described in more detail below, Figs. 4-6 illustrate a series of cross-sections through the spray tip sub-assembly 318, beginning with Fig. 4 at an interface between the male projection 370 of the malleable cannula 316 and the spray tip sub-assembly 318, and continuing distally until a location immediately proximate the end wall 375 of the tip cap 342. Fluid components from each of the fluid carrying lumens 330, 332 flow into the respective semi-cylindrical channels 330a, 332a, contact the proximal surface 416 and fillet 417 of the Quonset- shaped wedges 412, 414, and are directed radially outwardly through the fluid path archways 381, 383 (i.e., in a direction radially opposite the fluid component from the other fluid carrying lumen 332, 330, which helps to prevent premature cross-talk between the fluid components in the two fluid carrying lumens 330, 332). The fluid components then flow distally, toward the spaces between the flat side walls 377a, 377b, and 377c and the rounded side walls 377d, 377e, 377g, and 377h of the substantially octagonal distal portion of the tip insert 348 and the interior surface 373a of the cylindrical wall 373 of the tip cap 342.

[0038] As further illustrated in Fig. 1, the tip cap 342 includes a spinner region 380 with feeder channels 394, 396, and 398 leading thereto. The feeder channels 394, 396, 398 are generally triangular in shape, with sidewalls that taper inwardly toward one another as they approach the center of the spinner region 380. The diminishing cross-sectional area of the feeder channels 394, 396, 398 as they approach the spinner region 380 causes an increase in the velocity of the fluid components, as in a converging nozzle. As the fluid components enter the spinner region 380 from the three feeder channels 394, 396, 398, a vortex effect is created, serving to mix the fluid flows immediately prior to spraying the mixed components through a delivery opening 344 of the tip cap 342. The interference fit between the interior surface of the tip cap 342 and the end of the tip insert 348 prevents fluid from flowing from one feeder to another prior to entry into the spinner region 340. Although the feeder channels 394, 396 and 398 are shown as being formed in the tip cap 342, it is envisioned that the feeder channels could be formed in the tip insert 348 or have matching portions of the feeder channels formed in both the tip cap and tip insert.

[0039] Fig. 3 is a perspective view of the tip insert 348 within the tip cap 342 of the spray tip sub-assembly 318. A mixed component is being released from the delivery opening 344 at a distal end of the tip cap 342. The mixed component is shown by an alternating pattern of solid-bubbled and hollow-bubbled lines, wherein the solid bubbles represent a first component and the hollow bubbles represent a second component. Thus, the component is already mixed together before it is released from the delivery opening 344. The tip cap 342 is also provided with an elongate nipple region 345 on a distal side of the end wall 375 of the tip cap 342, intersecting the delivery opening 344. This elongate nipple region 345 serves to cause the tissue sealant formed of the mixed fluid components to disperse in a fan-like pattern, thereby promoting spraying of a desired tissue surface.

[0040] Fig. 4 is a cross-sectional view of the spray tip sub-assembly taken along the lines 4-4 of Fig. 3. The view shows the male projection 370 of the cannula 316 and the crescent- shaped channels 376 and 378 of the tip insert 348. The crescent-shaped channels 376 and 378 each carry only one mixing component from the fluid carrying lumens 330, 332.

Specifically, the crescent-shaped channel 376 of the tip insert 348 is filled with solid bubbles representing a first mixing component, and the ere scent- shaped channel 378 of the tip insert 348 is filled with hollow bubbles representing a second mixing component. At this point, the crescent- shaped channels 376, 378 of the tip insert 342 help keep the first and second mixing components from prematurely mixing when fluid passes from the malleable cannula 316 and into the tip insert 348 of the spray tip sub-assembly 318.

[0041] Fig. 5 is a cross-sectional view of the spray tip sub-assembly 318 taken along the lines 5-5 of Fig. 3. Here, the crescent- shaped channels 376, 378 of the tip insert 348 have directed the fluid from the fluid carrying channels 330, 332 of the malleable cannula 316 toward a space between walls of the tip insert 348 and the tip cap 342. The two mixing components are still separate from each other.

[0042] Fig. 6 is a cross-sectional view of a spray tip sub-assembly 318 taken along the lines 6-6 of Fig. 3. As illustrated in this view, the fluid has been even further directed from the fluid carrying channels 330, 332 of the malleable cannula 316 into the tip insert 348 and the tip cap 342. The first mixing component, indicated by solid bubbles, is now found in the space or first flow path A formed between the substantially flat side walls 377a, 377b and the rounded side walls 377g, 377h of the tip insert 348 and the interior surface 373a of the cylindrical wall 373 of the tip cap 342. The second mixing component is represented by hollow bubbles and is found in the space or second flow path B formed between the substantially flat side walls 377b, 377c and rounded side walls 377d, 377e of the tip insert 348 and the interior surface 373a of the cylindrical wall 373 of the tip cap 342. A portion of the solid-bubbled mixing component is about to mix with a portion of the hollow-bubbled mixing component in an area or third flow path C between the substantially flat side wall 377b of the tip insert 348 and the interior surface 373a of the tip cap 342.

[0043] As illustrated in Figs. 6 and 14, for example, the octagonal tip insert 328 includes rounded areas 377a and 377c extending from each side of substantially flat side wall 377b to rounded side walls 377h and 377d respectively. These rounded areas of the octagonal tip insert 328 are spaced from the inner surface 373a of the tip cap 34, forming annular transfer channels 350, 352 between the interior surface of the tip cap 342 and the octagonal tip insert 328 and ensuring a correct proportion or portion of each fluid component is being properly directed into the third flow path C formed between the flattened wall 377b and the tip cap 342. More specifically, a first transfer channel 350 is formed between the first flow path A and the third flow path C, and a second transfer channel 352 is formed between the second flow path B and the third flow path C. These transfer channels 350, 352 between the tip insert 348 and the tip cap 342 are designed such that a desired portion of each of the first and second mixing components may be forced together in the third fluid flow path C, thereby forming a mixture of the first and second mixing components before entry into the feeder channel 394. See, e.g., Figs. 6 and 7.

[0044] More specifically, the configuration of the tip insert 348 and the tip cap 342 is such that three flow paths for three fluid streams are created before each of the fluid streams separately enters one of the three feeder channels 394, 396, and 398 disposed in the tip cap 342. The interference fit between the tip insert 346 and tip cap 342 prevents cross talk between the feeder channels 394, 396, and 398. A ratio of the portions of the components being mixed can be set by dimensioning an interface and spacing of the transfer channels 350, 352 between the tip insert 348 and the tip cap 342, such that a desired proportion of the first mixing component only becomes one fluid stream, a desired proportion of the second mixing component only becomes a second fluid stream, and a desired proportion of the remaining portions of both the first and second mixing components become a third fluid stream, each of the fluid streams being created before separately entering the three feeder channels 394, 396, and 398. By maintaining the isolation of portions of the first and second mixing components and premixing the remaining portions of the first and second mixing components before any component enters the feeder channels 394, 396 and 398, mixing is optimized without leading to increased clogging.

[0045] Fig. 7 illustrates another cross-sectional view of a spray tip sub-assembly 318 this time taken along the lines 7-7 of Fig. 3. Here, the fluid has been directed to feeder channels 394, 396, and 398. The feeder 394 includes fluid components that have already begun to mix with one another, as illustrated by a combination of both the solid- and hollow-bubbled mixing components in that feeder 394. The feeder 396 includes the hollow-bubbled (second) mixing component only, and the feeder 398 includes the solid-bubbled (first) mixing component only. Thus, the two fluid components have already begun to mix with one another before the feeder 394 delivers the fluid to the spinner region 380; however, the other feeder channels 396 and 398 respectively deliver first and second mixing components that have not come into contact with one another. Instead, the first mixing component included in feeder 398 and the second mixing component included in feeder 396 are not mixed until the feeder channels 396, 398 deliver the respective components to the spinner region 380, at a relatively high velocity, wherein they are mixed in a vortex. This configuration allows the fluid components to gradually begin mixing with one another, since only that portion of each of the fluid components flowing into the feeder 394 begins mixing with the other fluid component prior to entry into the spinner region 380. The remaining portions of the fluid components flowing into one or the other of the feeder channels 396, 398 remain isolated from the other fluid component until reaching the spinner region 380. Thus, the remaining portions of the fluid components are mixed only immediately before passing through the delivery opening 344 of the tip cap 342 and have been maintained in isolation from one another from the barrels of the dual syringe 12, through the luer hub assembly 114 and the malleable cannula 316, and into the spray tip sub-assembly 318. [0046] Referring now to Fig. 8, the malleable cannula 316 further includes a proximal end region 354 having two elongate notches where portions of the malleable cannula 316 are shaved or otherwise cut back to expose semi-cylindrical channel regions 330b and 332b, each of which is an extension of a respective one of the fluid carrying lumens 330, 332. Like the male projection 370 at the distal end region 366, a male projection 430 is defined at the proximal end region 354 by that area of the malleable cannula 316 between the two elongate notches. The notches at the proximal end region 354 extend axially along the malleable cannula 316 from a proximal end wall 432 of the malleable cannula 316 to a stop wall 434 spaced axially inwardly (i.e., distally) of the proximal end wall 432.

[0047] The male projection 358 may engage a complementary female cannula mating port (not shown) of the distal hub of a luer sub-assembly, in a manner that directs the fluid components into the respective fluid carrying lumens 330, 332, without cross-talk between the fluid components.

[0048] Fig. 9 is a cross-sectional view of the malleable cannula 316 taken along the lines 9-9 of Fig. 8. The view illustrates all four lumens of the malleable cannula 316, the two fluid carrying lumens 330, 332, the third lumen 334, which may receive an annealed wire 164, and the fourth lumen 362.

[0049] Fig. 10 is a cross-sectional view of the malleable cannula 316 taken along the lines 10-10 of Fig. 8. The view illustrates the third and fourth lumens 334, 362, wherein the third lumen 334 may accommodate an annealed wire 164, helping to preserve a desired shape of the malleable cannula 316.

[0050] Figs. 18 and 19 illustrate a proximal hub 320 that may be used with the malleable cannula 316 referred to herein. A top plan view of the proximal hub 320 is illustrated in Fig. 18, and a cross-sectional view of the proximal hub 320 taken along the lines 19-19 of Fig. 18 is illustrated in Fig. 19. The proximal hub 320 includes two fluid channels 324, 326 to be placed in fluid communication with respective barrels 510, 512 of a dual syringe (Fig. 25). The barrels 510, 512 form reservoirs of the first component and the second component. A blade 325, as illustrated in Fig. 19, extends rearward adjacent to fluid channel 324 and fits into a slot 502 of a syringe assembly 500, as indicated in Fig. 25, to securely anchor the proximal hub 320 to the syringe assembly 500. Fitting the blade 325 into the slot 502 enables a surgeon to move the syringe assembly 500 around without leading to a disconnection of the syringe assembly 500 and the proximal hub 320 during use. The engagement is further strengthened by tabs 327 extending out sides adjacent to each of the fluid channels 324, 326 of the proximal hub 320, as shown in Figs. 18 and 19, and actuable clips 504 shown on either side of the syringe assembly 500 of Fig. 25. More specifically, after the blade 325 is inserted into the slot 502 of the syringe assembly, the clips 504 on either side of the syringe assembly are placed on the tabs 327 of the proximal hub 320, thereby resulting in a reinforced, secure connection between the proximal hub 320 and the syringe assembly 500.

[0051] As illustrated in Fig. 25, the syringe assembly may include two push tabs 506 connected to and below each of the clips 504 to enable movement of the clips to an open position that allow the proximal hub 320 and the blade 325 to be easily inserted within the syringe assembly 500. More specifically, to insert the blade 325 into the slot 502 of the syringe assembly 500, a user may first place her thumb and forefinger on each of the push tabs 506 connected to the clips 504, thereby placing the clips 504 in an open position. With her other hand, the user may insert the blade 325 of the proximal hub 320 into the slot 502, and further insert the fluid channels 324, 326 into the fluid containing barrels of the syringe assembly 500. The user may then release her thumb and forefinger from the tabs 506 attached to the clips 504 of the syringe, resulting in the clips 504 being easily placed on the tabs 327 of the proximal hub 320 and securely fastening the proximal hub 320 to the syringe assembly 500. [0052] Figs. 20-24 illustrate a distal hub of a luer-hub subassembly 322 intended to interface with the male projection at the proximal end of malleable cannula 316. As best illustrated in Figs. 22 and 23, a projection-receiving channel is provided at the proximal end of the female cannula mating port of the distal hub. Fluid from each the channels within the luer-hub subassembly is diverted into a respective one of the semi-cylindrical channel regions along the male projection of the malleable cannula 316, facilitated by complementary wedges 321, 323 within the cylindrical female cannula mating port of the distal hub.

[0053] While the applicator of the present disclosure has been described with respect to certain embodiments thereof, it will be understood that variations may be made thereto that are still within the scope of the appended claims.