Patent Description:
In recent years, minimally invasive surgical techniques have emerged as an alternative to conventional surgical techniques to perform a plurality of surgical procedures. Minimally invasive procedures differ from conventional surgical procedures in that a plurality of devices may be introduced into the body through a small incision. As a result, trauma to the body is greatly reduced, thereby decreasing the recovery time of the patient.

One example of a common minimally invasive surgery involves laparoscopic surgical procedures. Laparoscopic procedures may be used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, gallbladder disorders, etc. Typically, the patient undergoing the procedures will return home hours after undergoing surgery.

One challenge presented when performing minimally invasive surgical procedures relates to reducing bleeding at a surgical site when control of bleeding by standard surgical techniques, such as suturing, ligature and cautery, is ineffective or impractical. As opposed to conventional surgical procedures, the surgeon's access to the site of the incision is greatly reduced during minimally invasive procedures and conventional techniques for hemostasis may be difficult to effect.

Recently, the use of tissue sealants and other biological adhesive materials has emerged as an alternate technique for hemostasis. Such tissue sealants may include fibrin, which is comprised of co-reactive thrombin and fibrinogen materials, although other multiple component materials are available. Typically, the individual components of the sealant materials are stored in isolated reservoirs. When mixed, these components may coagulate very quickly, yielding a gel within a short period of time, perhaps <NUM> or <NUM> seconds. When applied to the exterior of the body, or when considerable access to the application site is possible, the rapid coagulative properties of the tissue sealant are advantageous. However, such fast-acting properties of conventional tissue sealants have presented potential problems of fouling or clogging during application through laparoscopic devices, which typically results in the destruction of the device.

The fibrin sealants used in the above-disclosed procedures are relatively labile and require low temperature storage, such as below about <NUM>ºC, to extend their shelf-life. Advantageously, each of the co-reactive materials is stored in separate reservoirs, such as syringes, and are only combined after thawing and delivery into the site of the incision to be closed. Most preferably, the syringes are glass syringes due to the inertness of glass.

The syringes are generally similar in size and can be easily mixed-up, so the separate storage of each component in similar syringes can cause difficulties in not only storage, but also in packing, shipping and when configuring them for delivery of the fibrin sealant in a medical facility. It would be advantageous if the syringes of the co-reactive materials could be selected and loaded prior to cooling, storage and delivery to ensure that they are properly matched.

Thus, there is a need for a cartridge capable of effectively housing at least two, separate glass syringes containing co-reactive components, wherein the housing is suitable for both storage of the syringes/co-reactive materials and for delivery of the materials.

Presented herein is a cartridge for storage and delivery of multiple co-reactive materials comprising an elongated holder body having substantially parallel longitudinal voids, multiple hollow cylindrical bodies disposed substantially parallel within the longitudinal voids, the multiple co-reactive materials separately disposed in the multiple hollow cylindrical bodies, wherein the multiple hollow cylindrical bodies have open proximal ends, nozzles at distal ends thereof, and pistons positioned inside, the pistons sealing the open proximal end and slidably moveable within the hollow cylindrical bodies and having no plungers attached; the cartridge further comprising a removable rear closure cap having plugs fitting into the open proximal ends of said multiple hollow cylindrical bodies.

In one form, the cartridge can further comprise removable closure caps sealing the nozzles.

In another form, the open proximal ends have diameters substantially the same as inner diameters of the hollow cylindrical bodies, and the nozzles have Luer tapers.

Advantageously, the hollow cylindrical bodies are glass syringe bodies, and the co-reactive materials are fibrinogen and thrombin.

In one form, the holder body comprises windows into each of the substantially parallel longitudinal voids.

In another form, the holder body comprises a longitudinal groove between the substantially parallel longitudinal voids.

Also presented is a dispensing device for simultaneous delivery and mixing of multiple co-reactive materials, comprising a cartridge having proximal and distal ends, the cartridge comprising an elongated holder body having substantially parallel longitudinal voids, multiple hollow cylindrical bodies disposed substantially parallel within the longitudinal voids, the multiple co-reactive materials separately disposed in the multiple hollow cylindrical bodies, wherein the multiple hollow cylindrical bodies have open proximal ends, nozzles having Luer tapers at distal ends thereof, and pistons positioned inside, the pistons sealing the open proximal ends and slidably moveable within the hollow cylindrical bodies and having no plungers attached, and a longitudinal housing having proximal and distal ends, structured and arranged to receive the cartridge, having plungers on the proximal end of the longitudinal housing, structured and arranged to contact proximal ends of said pistons; the cartridge further comprising a removable rear closure cap having plugs fitting into the open proximal ends of said multiple hollow cylindrical bodies.

In one form, the dispensing device further comprises a reactive material receiver having substantially parallel inlet ports a first axial distance apart, located at a distal end of the housing, said inlet ports having co-acting Luer tapers with those of said cylindrical body nozzles.

In another form, the reactive material receiver has substantially parallel exit ports a second axial distance apart and located distal to the inlet ports, and exit nozzles in fluid communication with the exit ports, wherein the second axial distance is different from the first axial distance.

In another form, the dispensing device further comprises a spray or drip mixing tip connected to the exit ports of the reactive material receiver, the mixing tip in fluid communication with the multiple hollow cylindrical bodies of the cartridge through channels within the reactive material receiver and the nozzles.

In yet another form, the longitudinal housing comprises a backbone portion having proximal and distal ends and longitudinal voids on either side of the backbone portion in a side portion of the housing, structured and arranged to accommodate the cartridge between the proximal and distal ends of the housing.

In another form, the longitudinal housing further comprises a clamp to hold the cartridge in the longitudinal void and bias the cartridge and nozzles toward the distal end of the housing, and a fixture at the proximal end of the housing in which the plungers are slidably captive.

In one form, the longitudinal housing comprises an elongated body, wherein the proximal end of the housing is open to receive the cartridge, and a hinged cover for the open proximal end of the housing, wherein said plungers are slidably captive in said hinged cover.

In this form, the hinged cover further comprises a locking tab structured and arranged to engage the proximal end of the housing and lock the cartridge within the housing.

In another form, an inner surface of the hinged cover further comprises one or more spring members for biasing the cartridge toward the distal end of the housing upon closure of the hinged cover, and an extractor hook to assist removal of the cartridge.

In another form, the dispensing device further comprises a reactive material receiver connected to the distal end of the housing with a central stabilizing rod extending from the reactive material receiver into an opening in either the housing or the cartridge, the central stabilizing rod having a nut which engages a thread surrounding the opening.

In this form, the reactive material receiver further comprises substantially parallel inlet ports having Luer tapers which coact with Luer tapers of the nozzles, and the combination of the Luer nut and Luer thread biases the nozzles into a sealing relationship with the inlet ports.

The forms disclosed herein are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:.

Described herein is a medical device which is a cartridge for holding liquid delivery syringes, especially glass syringes, and a housing for receiving the cartridge.

Each of the following terms written in singular grammatical form: "a," "an," and "the," as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases "a device," "an assembly," "a mechanism," "a component," and "an element," as used herein, may also refer to, and encompass, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, and a plurality of elements, respectively.

Each of the following terms: "includes," "including," "has," "'having," "comprises," and "comprising," and, their linguistic or grammatical variants, derivatives, and/or conjugates, as used herein, means "including, but not limited to.

It is to be understood that the various forms disclosed herein are not limited in their application to the details of the order or sequence, and number, of steps or procedures, and sub-steps or sub-procedures, of operation or implementation of forms of the method or to the details of type, composition, construction, arrangement, order and number of the system, system sub-units, devices, assemblies, sub-assemblies, mechanisms, structures, components, elements, and configurations, and, peripheral equipment, utilities, accessories, and materials of forms of the system, set forth in the following illustrative description, accompanying drawings, and examples, unless otherwise specifically stated herein. The apparatus, systems and methods disclosed herein can be practiced or implemented according to various other alternative forms and in various other alternative ways.

It is also to be understood that all technical and scientific words, terms, and/or phrases, used herein throughout the present disclosure have either the identical or similar meaning as commonly understood by one of ordinary skill in the art, unless otherwise specifically defined or stated herein. Phraseology, terminology, and, notation, employed herein throughout the present disclosure are for the purpose of description and should not be regarded as limiting.

The term "distal" refers to that end of a device or component which is closest to the dispensing end. The term "proximal" refers to that end of a device or component which is furthest away from the dispensing end.

As used herein the term "substantially parallel" when applied to elements of the disclosed article is intended to mean that the elements are close to but not necessarily perfectly parallel. For example the elements can be disposed at slight angles relative to one another, so long as they are confined within an overlying structure in which they are disposed.

Presented herein is a cartridge for storage and delivery of multiple co-reactive materials to a surgical site, such as an incision requiring sealing. In particular, the incision site can be one which is difficult to seal by conventional suturing, and instead requires use of a biological sealant. One well-known sealant is fibrin, which is formed when fibrinogen and thrombin are combined. While they are naturally occurring in vivo, these two co-reactive materials are commercially available as isolated materials, and can be stored and delivered to medical professionals for later mixing and use in sealing incisions, wounds or the like.

Long term storage of fibrin sealant is complicated by the fact that both the polymerizable material (fibrinogen) and the initiator or accelerator (thrombin) are biological materials and are relatively labile. Long term storage is facilitated by maintaining the temperature of the materials at or below freezing (<NUM>), as well as storing them in glass, well-known to be very inert and resistant to gas permeation. Accordingly, fibrinogen and thrombin have become commercially available frozen and stored or packaged in glass syringe bodies.

Additionally, cold storage shipping is relatively expensive, and cold storage space in facilities can be limited. The presently disclosed cartridge system limits the volume of the package that needs to be in cold storage. Further, if more than one unit of biologics is needed in a procedure (as is sometimes the case), the application device can be reloaded with another cartridge rather than obtaining a new device, thus reducing waste.

However, the use of glass syringes to deliver these co-reactive materials to cooperating medical apparatuses, such as manifolds and mixing tips, is complicated by the fact that tolerances on the Luer fittings thereof are often not tight enough to prevent leakage. Additionally, manipulating glass syringes in operating theaters is difficult. Advantageously, sealing of the Luer tapered nozzles to other apparatuses can be accomplished with a press fit between the glass nozzle and the corresponding receiving Luer taper. The presently disclosed apparatus achieves this press fit by use of biasing means other than Luer nuts on the nozzles, to create a sealing force between the glass nozzles and the receiving Luer tapers of the accompanying apparatus(es). This system minimizes the handling of glass syringes and maximizes the ease of their preparation and use.

Additionally, the selection and use of frozen glass syringes in a medical facility can present problems. Condensation on the cold glass can render the syringes slippery and prone to dropping and fracturing. Also, the necessity of selecting syringes filled with different materials from bulk storage could result in mismatching of syringes, requiring disposal of the mismatched pair and restart of the sealing procedure. According to the present disclosure, a cartridge apparatus is provided in which previously matched syringes of the differing materials are inserted and held into the cartridge prior to storage and shipment from the manufacturing facility. The subsequently frozen and delivered cartridge is more easily manipulated in the medical facility, reducing the chance of breakage and mismatching of components. Conveniently, the cartridge is structured and arranged to be received in a dedicated dispensing device, from which the co-reactive materials can be dispensed to downstream devices without leakage.

<FIG> illustrate the presently disclosed cartridge <NUM> which has an elongated holder body <NUM> having substantially parallel longitudinal voids 120a, 120b, first and second hollow cylindrical bodies 130a, 130b, such as syringes, disposed substantially parallel within the longitudinal voids 120a, 120b. Two co-reactive materials (e.g. thrombin and fibrinogen) are separately disposed in the first and second syringes 130a, 130b, which have open proximal ends <NUM>, nozzles <NUM> having Luer tapers at distal ends thereof, and pistons <NUM> positioned inside, the pistons sealing the open proximal end <NUM> and slidably moveable within the syringes. While being structured to receive plungers on their proximal ends, the pistons have no plungers attached. The cartridge can have removable closure caps <NUM> sealing the nozzles <NUM> and a removable rear closure cap <NUM> having substantially parallel plugs 140a, 140b, fitting into the open proximal ends <NUM> of the syringes.

The open proximal ends <NUM> of the syringes 130a, 130b, have diameters substantially the same as inner diameters of the syringes, and the nozzles <NUM> have Luer tapers. Advantageously, the syringes are glass and the co-reactive materials are fibrinogen and thrombin. The holder body <NUM> can have windows <NUM> in each of side-by-side longitudinal voids 120a, 120b, to facilitate thawing and warming of the co-reactive materials in the syringes, as well as viewing of the contents therein. Also, the holder body includes a longitudinal groove <NUM> between the substantially parallel longitudinal voids 120a, 120b, which groove helps to guide the cartridge into a dispensing device, described below. The holder body <NUM> can be made of a medically acceptable flexible plastic or polymer, such as polypropylene or polyethylene terephthalate, and the syringes can be snapped into place within the longitudinal voids.

The cartridge <NUM> is received into one or more dedicated dispensing devices which are structured and arranged specifically to hold the cartridge.

<FIG> illustrate a top- or side-loading dispensing device <NUM> for simultaneous delivery and mixing of the two co-reactive materials including a cartridge <NUM>, as described above, and a longitudinal housing <NUM> including a backbone portion 210a and having proximal and distal ends, the housing being structured and arranged to receive the cartridge <NUM>. The dispensing device <NUM> can be advantageously made from a medically acceptable flexible plastic or polymer, such as polypropylene or polyethylene terephthalate.

The dispensing device <NUM> can further comprise a reactive material receiver <NUM>, such as a manifold, either integral with or separate from the longitudinal housing <NUM>. The reactive material receiver has substantially parallel inlet ports <NUM> having Luer tapers which co-act with those of the hollow cylindrical body nozzles <NUM>, located a first axial distance apart at a distal end of the housing <NUM>, into which the cylindrical body Luer nozzles <NUM> are seated and sealed. Distal to the inlet ports <NUM> the reactive material receiver has substantially parallel exit ports <NUM> a second axial distance apart, wherein the second axial distance is different from the first axial distance, and a Luer nut and thread connector <NUM> in fluid communication with the exit ports <NUM>. The different first and second axial distances between inlet <NUM> and exit ports <NUM> of the reactive material receiver can be configured such that the reactive material receiver <NUM> adapts the co-reactive material flowpaths from the larger axial distance between syringe nozzles <NUM> to a smaller axial distance between the adapter's exit ports <NUM>. The dispensing device <NUM> can further include a spray or drip mixing tip <NUM> connected at the distal end of the reactive material receiver <NUM> with the Luer nut and thread connector <NUM>, the mixing tip <NUM> in fluid communication with the first and second hollow cylindrical bodies 130a, 130b, of the cartridge <NUM> through the various channels within the reactive material receiver <NUM> and nozzles <NUM>. The exit ports <NUM> can be covered with a cap <NUM> to seal the unit until use.

Additionally, the longitudinal housing <NUM> has a longitudinal void <NUM> in a side portion thereof, structured and arranged to accommodate cartridge <NUM> between the proximal and distal ends of the housing <NUM>. The longitudinal housing further includes a clamp <NUM> to hold the cartridge <NUM> in the longitudinal void <NUM> and to bias the cartridge <NUM> and thereby the nozzles <NUM> of the syringes 130a, 130b toward the distal end of the housing and tightly against the inlet ports <NUM> of the reactive material receiver <NUM> when the clamp is in the engaged position 216a. In this way the Luer-tapered nozzles <NUM> of the glass syringes are biased against the co-acting Luer tapers of the inlet ports <NUM>, made of the flexible plastic or polymer, and sealed against leakage of the co-reactive materials. The housing <NUM> has a fixture <NUM> at its proximal end which has slidably captive therein substantially parallel plungers <NUM>, structured and arranged to contact the proximal ends of the pistons <NUM> in the syringes 130a, 130b, held within the cartridge <NUM>. When dispensing of the co-reactive materials is desired, the substantially parallel plungers <NUM> are pushed into the syringe bodies and against pistons <NUM>, such that the liquefied co-reactive materials are forced through the reactive material receiver <NUM> and into the spray or drip mixing tip <NUM>.

<FIG> depict an alternative design for biasing the syringe nozzles <NUM> into and against the inlet ports <NUM> of a reactive material receiver <NUM> which is separate from the longitudinal housing <NUM>. In this design, the reactive material receiver <NUM> is provided with a central stabilizing rod <NUM> which fits into an opening in the cartridge <NUM> or housing <NUM>. The stabilizing rod <NUM> is provided with a nut 217a, such as a Luer nut, which when the reactive material receiver is mated with the cartridge <NUM> or longitudinal housing <NUM>, can be screwed onto a co-acting thread, such as a Luer thread provided around the opening in the cartridge <NUM> or housing <NUM>.

<FIG> depict an alternative, rear-loading design for the dispensing device <NUM>, wherein the longitudinal housing <NUM> is an elongated body having proximal and distal ends. The proximal end of the housing <NUM> is open to receive the cartridge <NUM>, and has a hinged cover <NUM> connected to the housing at hinge 315a. The hinged cover <NUM> has slidably captive therein substantially parallel plungers <NUM> structured and arranged to contact the pistons <NUM> in the syringe bodies 130a, 130b. The hinged cover <NUM> further includes a locking tab 315c structured and arranged to engage the proximal end of the housing <NUM> so as to lock the cartridge <NUM> into the housing <NUM>. Optionally an inner surface of the hinged cover further comprises one or more spring members, in this case spring tabs 315b, for applying pressure to the distal end of the cartridge <NUM> upon closure of the hinged cover <NUM>, and an extractor hook 315d to assist removal of the cartridge when the cover is opened. It should be understood that the spring members can also be compression springs, or the like. The extractor hook 315d helps to overcome the friction of the engaged Luer fittings as the hinged cover is opened, rather than requiring a separate action.

The distal end of dispensing device <NUM> has a reactive material receiver <NUM> with Luer tapered inlet ports <NUM> which co-act with Luer tapered nozzles <NUM> of the glass syringes of the cartridge <NUM>. As can be understood, the spring member(s) 315b compress the cartridge <NUM> when the hinged door <NUM> is closed, forcing nozzles <NUM> to seat and seal in the inlet ports <NUM>. The reactive material receiver likewise can have Luer-type exit ports <NUM> at its distal end, and is similar to that in the above-described device in that it is configured to adapt the liquid pathway for the co-reactive materials from the axial distance between the exit nozzles <NUM> of the syringes and a different axial distance between the inlet ports of a manifold <NUM>. Manifold <NUM> has interior passages which further converge the mutually exclusive co-reactive material passages to a separation sufficient to enter mixing tip <NUM>, wherein the co-reactive materials are mixed immediately prior to delivery to the surgical site.

The devices disclosed herein are applicable to the medical field.

Claim 1:
A cartridge (<NUM>) for storage and delivery of multiple co-reactive materials comprising:
an elongated holder body (<NUM>) having substantially parallel longitudinal voids (120a, 120b);
multiple hollow cylindrical bodies (130a, 130b) disposed substantially parallel within said longitudinal voids;
said co-reactive materials separately disposed in said multiple hollow cylindrical bodies,
wherein the multiple hollow cylindrical bodies have open proximal ends (<NUM>), nozzles (<NUM>) at distal ends thereof, and pistons (<NUM>) positioned inside, said pistons sealing the open proximal end and slidably moveable within the hollow cylindrical bodies and having no plungers attached; and
characterised in that the cartridge further comprises a removable rear closure cap (<NUM>) having plugs (140a, 140b) fitting into the open proximal ends of said multiple hollow cylindrical bodies.