Addition to a medical applicator

The presently disclosed subject matter relates to an addition to a medical applicator in general and in particular to an addition to a medical applicator for applying on a surface a curable liquid substance having multi components.

TECHNOLOGICAL FIELD

The presently disclosed subject matter relates to a medical applicator in general and in particular to a medical applicator for applying on a surface a curable liquid substance having multi components.

BACKGROUND ART

BACKGROUND

Medical treatments and procedures often entail applying medicaments on a surface. Such medicaments can be a composition comprising two or more components that for optimal results should not be mixed together until use.

U.S. Pat. No. 5,810,885 discloses a device for applying a multi-component fluid, such as medical tissue or dental adhesives. The device comprises a headpiece having channels for each fluid extending from an inlet side of the headpiece to a connection site of the headpiece. The device further includes a tubular body comprising an inlet end facing the connection site of the headpiece and an outlet end facing away from the inlet end.

FIG. 1shows another known medical applicator10configured for applying a multicomponent medicament on a surface, for example, a curable liquid substance. The medical applicator10includes a headpiece (also referred to as manifold)12having an outlet port14to which a tubular body15is coupled, and two or more cannulas16aand16binto which the components can be fed. Each of the cannulas16aand16bcan be terminated in a hub18aand18b, respectively, configured for coupling thereto a tip of a syringe, such that components contained in the syringe can be introduced into the cannulas16band16bthrough the hubs18aand18b.

As shown, the syringes20aand20bcoupled to the hubs18aand18b, receptively, can include a bridging member23coupling the plungers22thereof to one another, such that both plungers are operated simultaneously so that the components contained in the syringes20aand20bare introduced into the hubs18aand18bat the same time.

The medical applicator10can further include a lumen inlet25for receiving therein gas from an exterior source, for example, by coupling thereto an air tube. The lumen inlet25is in fluid communication with the tubular body15such that gas can be delivered, for example for atomization of the multicomponent medicament e.g. the curable liquid substance.

GENERAL DESCRIPTION

There is provided according to an aspect of the presently disclosed subject matter an addition to a medical applicator. The medical applicator is configured for applying a multicomponent medicament such as a curable liquid substance and includes a lumen inlet for receiving therein gas from an exterior source, and a tubular body for applying the curable liquid substance on a surface wherein the tubular body is in fluid communication with the lumen inlet. The addition can be configured to deliver powder to the surface. The addition comprising a turbulating unit configured for mixing the gas with a powder stored in a vial. The turbulating unit having an inlet port connectable to the exterior source, an outlet port connectable to the lumen inlet of the medical applicator and a spike member configured for being entered into the vial and having a first passage for providing fluid communication between the inlet port and the vial and a second passage for providing fluid communication between the vial and the outlet port. Whereby assembling the addition with the medical applicator enables delivery of the substance and the powder on the surface.

The delivery of the liquid substance and the powder to the surface can be carried out simultaneously. The delivery of the substance and the powder to the surface can be carried out sequentially. The delivery of the substance and the powder to the surface can be carried out alternatingly.

The second passage can be configured to allow a flow of gas homogeneously mixed with the powder.

The spike member can include a beveled tip configured for introducing the spike through a membrane covering the opening of the vial.

The gas can be a medical gas (e.g. air, N2, CO2or other medical gases like oxygen), and the powder can be a medicament. The powder can comprise solid fibrinogen particles and/or solid thrombin particles.

The liquid substance can include at least a first component and a second component wherein the first component being activated by the second component.

The tubular body can contain a first channel for transferring therethrough the first component, a second channel for transferring therethrough the second component and a third channel for transferring therethrough the powder.

The applicator can comprise a first cannula hub for providing therethrough the first component and a second cannula hub for providing therethrough the second component.

The first component can comprise liquid fibrinogen, and the second component can comprise liquid thrombin.

The turbulating unit can be configured for sealing engagement with the opening of the vial.

The turbulating unit can be configured to homogeneously mix the powder with the gas.

The turbulating unit can be configured to form a mixture of the powder and the gas with a predetermined concentration of the powder in the gas.

The turbulating unit can be configured to form a mixture of the powder and the gas with a concentration of powder to gas ranging from 25 mg powder/liter of gas to 35 mg powder/liter of gas.

The addition can further comprise a first lumen configured for fluidly coupling the inlet port to the exterior source.

The addition can further comprise a second lumen configured for fluidly coupling the outlet port to the lumen inlet of the medical applicator.

The addition can further comprise a bypass lumen fluidly coupling the first lumen directly with said second lumen.

The addition can further comprise a valve coupled to the bypass lumen, the valve being configured to shift between a first position in which gas flow can be allowed between the exterior source and the vial whereby the powder can be mixed with the gas and a second position in which gas flow can be allowed between the exterior source and the bypass lumen whereby the gas flows directly to the lumen inlet.

According to a further aspect of the presently disclosed subject matter there is provided an applicator assembly comprising: at least one cannula hub for providing therethrough a liquid substance; a lumen inlet for receiving therein gas from an exterior source; and a turbulating unit configured for mixing the gas with a powder stored in a vial. The turbulating unit including an inlet port connectable to the exterior source; an outlet port connectable to the lumen inlet; and a spike member configured for being entered into the vial and having a first passage for providing gas communication between the inlet port and the vial and a second passage for providing fluid communication between the vial and the outlet port. The applicator assembly further comprising a tubular body for applying the liquid substance and the powder on a surface.

The applicator assembly can further comprise a first lumen fluidly coupling the inlet port to the exterior source.

The applicator assembly can further comprise a second lumen fluidly coupling the outlet port to the lumen inlet.

The applicator assembly can further comprise a bypass lumen fluidly coupling the first lumen directly with the second lumen or with the lumen inlet.

The applicator assembly can further comprise a valve coupled to the bypass lumen and the valve being configured to shift between a first position in which gas flow can be allowed between the exterior source and the vial whereby the powder can be mixed with the gas, and a second position in which gas flow is allowed between the exterior source and the bypass lumen whereby the gas flows directly to the lumen inlet.

The substance can include a first liquid component and a second liquid component wherein said first component being activated by the second component and wherein the assembly can include a first cannula for transferring therethrough the first component, a second cannula for transferring therethrough the second component.

The tubular body can contain a first channel for transferring therethrough the first component, a second channel for transferring therethrough the second component and a third channel for transferring therethrough the gas and powder.

According to yet a further aspect of the presently disclosed subject matter there is provided a method for applying a powder and a liquid curable substance on a surface, by utilizing an applicator assembly as described above. The method comprising: providing pressurized gas into a vial having the powder stored therein, such that a mixture of the gas and the powder can be formed; transferring the mixture towards the lumen inlet; applying with the tubular body the mixture on the surface; providing the liquid substance into the cannula hub; and applying with the tubular body the substance onto the surface.

The pressure of the gas delivered to the vial and/or to the medical applicator can be in the range of 5 to 30 psi.

The step of applying the substance and the step of applying mixture can be carried out simultaneously.

The step of applying the substance and the step of applying the mixture can be carried out sequentially.

The step of applying the mixture and the step of applying the substance can be carried out alternatingly.

The substance can be formed by a first liquid component and a second liquid component wherein the first component can be activated by the second component.

The surface can be a moist surface, such as a bleeding wound, a leaking defect, in a subject. In another embodiment of the invention, the tissue is moist from a fluid which is fibrinogen free. The term “fibrinogen free” refers, for example, to a fibrinogen concentration of lower than 1.5 g/L.

The term “moist surface” e.g. a moist tissue refers to a wet tissue and includes e.g. mucosa, mucosa tissue and other moist tissue.

The device can be used to stop bleeding, to seal leaks, to join structures, to enhance healing, and to reduce adhesions.

As used herein, the term “defect” refers to a tear, aperture, bore, fissure, puncture, hole, crack, opening, slit, gap, perforation, fracture, puncture or rupture, leak e.g. in a tissue. E.g. the defect can be formed following an anastomosis procedure. The defect can be congenital e.g. hernia; a condition resulting from body related pathology e.g. seroma, hernia, infection, inflammation; formed after surgery, suturing and/or stapling; or a condition resulting from a non-body factor e.g. accidents, injuries.

The term “leak” refers to the escape or pass of a substance e.g. fluid, viscous material and/or air e.g. through a tear, aperture, bore, fissure, puncture, hole, crack, opening, slit, gap, perforation, fracture, puncture or rupture in a tissue.

The term “anastomosis” typically refers to a surgical procedure which is used to reconnect two or more sections of an organ or tissue. The procedure can be used following sectioning of the urinary tract (urethra), throat (esophagus), or in bowel surgery. The procedure can also be used following the excision of a diseased tissue (such as inflamed, cancerous or otherwise pathological tissue e.g. ulcerative disease).

The wet surface can be a surface of a body part of a patient e.g. any tissue that contains liquids or air. The term “surface” includes, but is not limited to, the genital area, including the uterus, vagina and ovaries; the lungs; the anus; the spleen; the liver; the dura mater; the renal; the esophagus; the stomach; the pancreas; the pancreatic duct; the gall bladder; the bile duct; the intestine (including the small intestine and the large intestine); and the cardiac muscle. The surface can be a bleeding or a non-bleeding site. In one embodiment of the invention, the surface is a non-bleeding site. In another embodiment of the invention, the surface is wet from a fluid which is coagulation factor free (e.g. free of fibrinogen). The surface can also be any surface e.g. a working surface, a surface of a prosthetic device.

As used herein, the term “curable” in connection with a liquid composition, refers to a composition which can undergo an interaction between its components leading to an increase in viscosity of the composition. Such interactions include polymerization and/or cross-linking of components, achieved by means that include, but are not limited to, use of activating agents such as catalysts, or physical activators such as heat, radiation e.g. ultraviolet radiation, electron beams, or combinations thereof.

In some embodiments, the curable liquid composition comprises at least two components. In some embodiments, a first of at least two components is activated by a second of at least two components. In some such embodiments, the first component comprises fibrinogen. In some such embodiments comprising fibrinogen, the second component, for activation of fibrinogen, comprises thrombin.

DETAILED DESCRIPTION OF EMBODIMENTS

As discussed hereinabove in the Background SectionFIG. 1shows a known medical applicator10configured for applying a multicomponent medicament on a surface, for example, a curable liquid substance, including two or more components. The medical applicator10includes two or more cannulas16aand16binto which the components can be fed and a tubular body15for applying thereof on a surface.

According to an example the medical applicator10further includes a lumen inlet25for receiving therein gas from an exterior source.FIG. 2shows an addition30to a medical applicator10configured for providing a mixture of a gas and a powdered component to the medical applicator. The addition30comprising a turbulating unit35configured for mixing gas, such as a medical gas, with a powder stored in a vial5. The turbulating unit35includes an inlet port37a(shown inFIG. 3) connectable to the exterior source, such as a gas tank (not shown), and an outlet port37bconnectable to the lumen inlet25of the medical applicator10.

In addition, the turbulating unit35can further include a spike member40configured for being entered into a vial, and can include a beveled tip45configured for introducing the spike through a membrane covering the opening of the vial5.

The spike member40includes a first passage42afor providing fluid communication between the inlet port37aand the inside volume of the vial5and a second passage42bfor providing fluid communication between the inside volume of the vial5and the outlet port37b.

The turbulating unit35is configured to form a mixture of the powder stored in the vial5and the gas with a predetermined concentration thereof. That is to say, the amount and rate of gas introduced to the vial is set in accordance with the required concentration of the mixture of the powder and the gas. It is appreciated that the concentration level of the mixture may depend on various parameters such as the specific gravity of the gas, the pressure in the exterior source, the properties of the powder stored inside the vial5, etc. For example, the pressure of the gas delivered to the vial can be 5 to 30 psi and/or the volumetric flow rate can be set to 2-7 liter gas per minute. In addition, it is appreciated that the diameter of the first passage42ais configured such that the gas introduced therethrough homogeneously mixes the powder inside the vial5.

The turbulating unit35can be further configured for sealing engagement with the opening of the vial5, such that the desired pressure inside the vial5is maintained while the gas, or other fluids are introduced therein.

According to an example the addition30further includes a first lumen39aconfigured for fluidly coupling the inlet port37ato the exterior source of gas, such as to the gas tank. According to another example, the addition30can include a second lumen39bconfigured for fluidly coupling the outlet port37bto the lumen inlet25of the medical applicator10. This way the addition can be assembled together with an applicator of any kind, that is to say the second lumen39bcan serve as an adaptor between the outlet port37band the lumen inlet25of the medical applicator.

According to an example the second lumen39bcan be configured to allow disposing the turbulating unit35and the vial5remotely from the applicator facilitating thereby the use of the applicator. This way, the applicator10can be operated by one medical attendant while the addition30can be operated by another medical attendant.

Utilizing the applicator10with the addition30allows applying a curable liquid substance on a surface, for example on a tissue for holding together two adjacent tissue portions, such as following a surgery, and a powder such as solid fibrinogen and/or solid thrombin, e.g. as disclosed in WO 2011092694, or any other powder which can facilitate treatment.

In addition the gas delivered from the exterior source and introduced into the vial can be a medical gas, and wherein the powder can be a medicament such as a medicament including solid fibrinogen particles and/or solid thrombin particles.

The curable liquid substance applied by the applicator can include a first component contained within the first syringe20aand a second component contained within the second syringe20b. The first component can be such which interacts with the second component, for example the first component can include fibrinogen, and the second component can include thrombin. Examples of the two components include, but are not limited to, fibrinogen and thrombin, alginate and calcium, pectin and calcium a synthetic sealant such as acrylates, cyanoacrylates, and polyethylene glycol (PEG) polymers with their crosslinkers; and a semisynthetic sealant e.g. made from a combination of biological and synthetic materials such as gelatin-formaldehyde-resorcinol (GFR) glue, albumin and glutaraldehyde.

In one embodiment of the invention, the two components of the substance are fibrinogen and thrombin. In such an embodiment, when the two liquid components are mixed polymerization process is activated and application of the sealant is advantageously carried out without delay before resistance to flow becomes excessive. This way, the first and second components can be in a liquid (e.g. aqueous) form when stored separately, and can cure when mixed together, or engage one another. Thus, the first component can be applied on the surface through the first cannula hub18a, while the second component is applied through the second cannula hub18b.

As shown inFIG. 6in order to preclude undesirable activation of the first component by the second component inside the tubular body15, the latter can contain a first channel17afor transferring therethrough the first component, a second channel17bfor transferring therethrough the second component. Thus, the activation of the component takes place outside the tubular body15, for example on the treated surface e.g. as in WO2012168933A2[1] and as described in U.S. Pat. No. 8,403,882. The tubular body15can further include a third channel17cfor transferring therethrough the mixture of the powder and the gas.

Alternatively, the two components can be mixed within the device prior to exiting the tip of the tubular body. In that case the tubular body can be structured as described in WO10095128A2, U.S. Patent Application 2007/0191781 A1.

According to the presently disclosed subject matter the operator can provide pressurized gas into the vial through the first lumen39aand inlet port37aof the turbulating unit35. The pressurized gas causes turbulence inside the vial resulting in a mixture of the powder therewith. Due to the continuous flow of pressurized gas the mixture is urged into the outlet port37band the second lumen39btowards the lumen inlet25of the applicator10. The mixture can then be applied with the tubular body15on the surface e.g. the surface to be treated.

At this point the plungers22of the syringes20aand20bcan be activated by pushing the bridging member23so as to urge the first and the second components towards the tubular body15, through the first and second hubs18aand18b, respectively.

The components can then be applied at least partially on the applied powder through the tubular body15and onto the surface, resulting in the formation of the curable substance.

It is appreciated that delivery of the components of the curable substance and the powder on the surface can be carried out simultaneously, sequentially or alternatingly.

According to an example, the components of the curable substance can be delivered through a first and second channels17aand17bof the tubular body (FIG. 6), while the powder can be delivered through a third channel17c, such that the powder does not engage the components of the curable substance or residue thereof, if so desired.

In another example, the powder can be delivered through the same channel as that through which the components are delivered. In the latter case the powder can be delivered before the components while the channels17aand17bare still empty of any component residue.

It is appreciated that in the event where all the powder from the vial is delivered, gas from the external source can be further delivered through the tubular body. This way the gas can be utilized for cleaning the channels of the tubular body of any component residue.

In addition, if the tubular body ofFIG. 6is utilized, once the vial is empty of powder, gas can be delivered through the empty vial, towards the third channel17cof the tubular body15while the first and second components are delivered through the first and second channels17aand17brespectively. This way the gas can be used for atomization of the components, such that the components are sprayed over the treated surface.

According to an example, a bypass lumen (not shown) can be provided. The bypass lumen allows the operator to provide gas form the exterior source directly to the medical applicator10without entering into the vial and/or mixing thereof with the powder inside the vial5. For example such bypass lumen can be placed between the first lumen39aand the second lumen39b. This example is explained in more detail hereinafter with reference toFIG. 7.

Reference is now made toFIG. 7, the presently disclosed subject matter further provides an applicator assembly50having a medical applicator51, substantially the same as the applicator ofFIG. 1and having a headpiece52including a tubular body55, two or more cannulas56aand56binto which the components can be fed, and a lumen inlet65for receiving therein gas from an exterior source. The applicator assembly50further includes an addition70substantially the same as the addition30of the previous examples and comprising a turbulating unit75configured for mixing gas, such as a medical gas, with a powder stored in a vial5. The turbulating unit75includes an inlet port77aconnectable to the exterior source e.g. via a first lumen79a, and an outlet port77bconnectable to the lumen inlet65of the medical applicator51e.g. via a second lumen79b.

According to this example, the assembly50further includes a bypass lumen80fluidly coupling the first lumen79adirectly with the second lumen79b. The bypass lumen80allows the operator to provide the gas form the exterior source directly to the medical applicator51without entering into the vial and/or mixing thereof with the powder inside the vial5.

The bypass lumen80can be further provided with a valve85coupled thereto. In one embodiment, valve85allows gas flow from the exterior source, to be apportioned from the first lumen79ainto the inlet port77aand the bypass lumen80. The valve85can be configured to shift between a first position and a second position. In the first position, gas flow is allowed between the exterior source and the vial5, through the first lumen79aand into inlet port77a, whereby the powder is mixed with the gas. In the second position, a direct gas flow is allowed between the exterior source and the lumen inlet65of the medical applicator51through the bypass lumen80. Thus, in the second position, gas from the exterior source can be fed into the medical applicator, without entering into the vial and/or mixing thereof with the powder inside the vial5.

Referring back toFIGS. 3 and 4, the spike member40includes a first passage42afor providing fluid communication between the inlet port37aand the inside volume of the vial5and a second passage42bfor providing fluid communication between the inside volume of the vial5and the outlet port37b. Passage42acan be oriented laterally with respect to the spike member40. Lateral orientation enables greater separation between the first passage42aand the second passage42bwhich thereby allows for more efficient transfer of powder to the second passage42b. Further, the lateral orientation can be angled such that gas inflow through first passage42acreates a swirling effect within vial5to more efficiently engage the powder with the gas such that a more homogenous mixture is formed.

Referring again toFIG. 7, valve85can be configured to allow for proportional distribution of the gas inflow from first lumen79asuch that a portion of the gas flow passes through first passage42aand a second portion passes through bypass lumen80. Proportional distribution enables greater control over the concentration of powder delivered through second lumen79band ultimately to the tissue surface. This effect may also be achieved by the addition of a variable restrictor element within the bypass lumen80or between valve85and inlet port77a. This feature can be used to adjust for variation in available gas pressure to enable more predictable delivery of powder volume. Adjustment positions may be pre-calibrated and labeled to correspond to various gas pressure supplies.

The presently disclosed subject matter thus provides an addition to a medical applicator (10), the medical applicator configured for applying a curable liquid substance, and including a lumen inlet (25) for receiving therein gas from an exterior source, and a tubular body (15) for applying the curable liquid substance on a surface, wherein the tubular body is in fluid communication with the lumen inlet, the addition comprising a turbulating unit (35) configured for mixing the gas with a powder stored in a vial (5). The turbulating unit having: an inlet port (37a) connectable to the exterior source, an outlet port (37b) connectable to the lumen inlet (25) of the medical applicator; and a spike member (40) configured for being entered into the vial and having a first passage (42a) for providing fluid communication between the inlet port (37a) and the vial (5), and a second passage (42b) for providing fluid communication between the vial (5) and the outlet port (37b). Whereby assembling the addition with the medical applicator enables delivery of the substance and the powder on a surface.

The second passage (42b) can be configured to allow a flow of the gas homogeneously mixed with the powder.

The spike member (40) can include a beveled tip (45) configured for introducing the spike through a membrane covering the opening of the vial.

The applicator can comprise a first cannula hub (18a) for providing therethrough the first component and a second cannula hub (18b) for providing therethrough the second component.

The turbulating unit (35) can be configured for sealing engagement with the opening of the vial.

The turbulating unit (35) can be configured to homogeneously mix the powder with the gas.

The turbulating unit (35) can be configured to form a mixture of the powder and the gas with a predetermined concentration of the powder in the gas.

The addition can further comprise a first lumen (39a) configured for fluidly coupling the inlet port (37a) to the exterior source.

The addition can further comprise a second lumen (39b) configured for fluidly coupling the outlet port (37b) to the lumen inlet (25) of the medical applicator.

The addition can further comprise a bypass lumen (80) fluidly coupling the first lumen (39a) directly with the second lumen (39b).

The addition can further comprise a valve coupled to the bypass lumen, the valve being configured to shift between a first position in which gas flow is allowed between the exterior source and the vial (5) whereby the powder is mixed with the gas, and a second position in which gas flow is allowed between the exterior source and the bypass lumen whereby the gas flows directly to the lumen inlet (25).

The applicator is capable of applying, liquid solution in dripping form, atomized liquid solution with gas, powder with gas, and combinations thereof.

The presently disclosed subject matter further provides an applicator assembly (50) comprising: at least one cannula hub (18) for providing therethrough a curable liquid substance; a lumen inlet (25) for receiving therein gas from an exterior source; and a turbulating unit (35) configured for mixing the gas with a powder stored in a vial (5), the turbulating unit including an inlet port (37a) connectable to the exterior source; an outlet port (37b) connectable to the lumen inlet (25); and a spike member (40FIG. 3) configured for being entered into the vial and having a first passage (42a) for providing fluid communication between the inlet port (37a) and the vial (5) and a second passage (42b) for providing fluid communication between the vial (5) and the outlet port (37b); and a tubular body (15) for applying the substance and a mixture of the gas and the powder on a surface.

The applicator assembly can further comprise a first lumen (39aFIG. 2) fluidly coupling the inlet port (37a) to the exterior source.

The applicator assembly can further comprise a second lumen (39b) fluidly coupling the outlet port (37bFIG. 2) to the lumen inlet (25).

The applicator assembly can further comprise a bypass lumen (80,FIG. 7) fluidly coupling the first lumen directly with the second lumen.

The applicator assembly can further comprise a valve (85) coupled to the bypass lumen the valve being configured to shift between a first position in which gas flow is allowed between the exterior source and the vial (5) whereby the powder is mixed with the gas, and a second position in which gas flow is allowed between the exterior source and the bypass lumen whereby the gas flows directly to the lumen inlet.

Those skilled in the art to which the presently disclosed subject matter pertains will readily appreciate that numerous changes, variations, and modifications can be made without departing from the scope of the invention, mutatis mutandis.