Syringe device with piston having an access aperture and methods of using and processes of manufacturing the same

Abstract

A syringe device with piston characterized by having an access aperture and process of manufacturing the same are described; a method of manipulating a biological material within a syringe device is also described; the syringe device comprises: a syringe tube and a plunger; the process comprises the steps of: pre-manufacturing a syringe tube, molding a plunger, molding a nexus part, pre-manufacturing a piston and assembling the syringe device; the method comprises the steps of: providing a syringe device, drawing the plunger, collecting a sample of a biological material, providing an access to the throughout aperture, inserting at least one needle, manipulating the sample of the biological material.

Description

SYRINGE DEVICE WITH PISTON HAVING AN ACCESS APERTURE AND METHODS OF USING AND PROCESSES OF MANUFACTURING THE SAMETECHNICAL FIELD

[0001] In general, the present invention pertains to the art of medical devices. In particular, the invention relates to a syringe device plunger with piston characterized by having an access aperture, as well as to methods of using and processes of manufacturing the same.BACKGROUND ART

[0002] It is believed that the current state of the art is represented by the following patent literature: US10213562, US5215536, US9561327 and WO9101768.

[0003] US10213562 discloses a replaceable needle assembly is provided for a retractable, prefilled syringe comprising a barrel having a mounting member and a plunger, whereby the retractable needle can be replaced by a user without affecting the retraction mechanism. The replaceable needle assembly of US10213562 comprises a needle fitted to a retractable needle mount and a needle retainer. The needle mount in US10213562 is removably, screw-threadedly mountable to the mounting member of the barrel. The needle retainer in US10213562 comprises a plurality of fingers that releasably engage the retractable needle to thereby prevent inadvertent retraction of the retractable needle before engagement by the plunger. The plunger in US10213562 comprises a plunger seal comprising an outer member and an inner member that engages the needle for spring- driven retraction.SUMMARY OF THE INVENTION

[0004] The following summary of the invention is provided to exhibit the basic understanding of some principles, underlying various aspects and features of the invention. This summary is not an extensive overview of the invention and as such it is not necessarily intended to particularly identify all key or critical elements of the invention and is not to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the following more detailed.

[0005] The invention was made in view of the deficiencies of the prior art and provides systems, methods and processes for overcoming these deficiencies. In accordance withsome embodiments and aspects of the present invention, there is provided a syringe device with piston characterized by having an access aperture comprises: a syringe tube comprising: an essentially elongated cylindrical shell shaped barrel, a frusto-conical tip, at a distal portion of the barrel, at least one finger flange, at a proximal portion of the barrel, configured for manual grip; a plunger comprising: an essentially elongated shaft, comprising an essentially firm material, a thumb rest at a proximal portion of the elongated shaft, configured for exerting a manual force, onto the plunger, a piston disposed at a distal portion of the plunger, comprising an essentially resilient material, configured to form a sealing arrangement with an interior surface of the barrel, whilst contiguously translatable alongside thereof, the piston comprising at least one structural element configured for attachment to a matching structural element, a nexus part disposed in-between the piston and the plunger, comprising an essentially firm material, configured to firmly attach the piston to the nexus part, thereby sustaining exerting of a substantial pulling force onto the plunger, whilst the piston remains firmly attached to the nexus part, the nexus part comprising at least one structural element matching to at least one structural element of the piston, in which the nexus part forms a throughout aperture, configured to facilitate an access to an interior of the syringe device, from a proximal face thereof.

[0006] In some embodiments, the nexus part further comprises a fastener element, whereas the distal portion of the elongated shaft comprises a respective fastener element, whereby the nexus part is readily connectable to and disconnectable from the distal portion of the elongated shaft of the plunger.

[0007] In some embodiments, the fastener comprises a screw threading.

[0008] In some embodiments, the at least one structural element of the nexus part configured to firmly attach the piston to the nexus part comprises a circumferential groove, matching to the at least one structural element of the piston.

[0009] In some embodiments, the at least one structural element of the piston configured to firmly attach the piston to the nexus part comprises a circumferential rim, matching to the at least one structural element of the nexus part.

[0010] In some embodiments, remains firmly attached to the nexus part further comprises essentially preventing a rotational displacement of the piston relative to the nexus part.

[0011] In some embodiments, the at least one structural element of the nexus part comprises a plurality of dowels.

[0012] In some embodiments, the plunger further comprises at least one detent assembly comprising: a stopper element, accommodatable within the at least one recess in the essentially elongated shaft of the plunger; a biasing means, configured for spontaneously driving the stopper element outwardly from the at least one recess in the essentially elongated shaft of the plunger; at least one retaining element, configured for restricting a movement of the stopper element within the at least one recess in the essentially elongated shaft of the plunger, thereby preventing the stopper element from leaving the at least one recess; in which the stopper element of the at least one detent assembly is axially translatable within the at least one recess, in a direction essentially orthogonal to the longitudinal centerline of the essentially elongated shaft of the plunger.

[0013] In some embodiments, the at least one detent assembly comprises a first detent assembly and a second detent assembly, in which the first detent assembly is disposed towards the distal portion of the shaft, whereas the second detent assembly is disposed towards the proximal portion of the shaft.

[0014] In some embodiments, the retaining element is selected from the group consisting of: a retaining element forming an integral part of the essentially elongated shaft of the plunger, a retaining element forming an integral part of the stopper element, an external retaining element forming no integral part of neither the essentially elongated shaft of the plunger nor the stopper element.

[0015] In accordance with some embodiments and aspects of the present invention, there is provided a process of manufacturing a syringe device with piston characterized by having an access aperture comprises the steps of: pre-manufacturing a syringe tube comprising an essentially elongated cylindrical shell shaped barrel, a frusto-conical tip, at least one finger flange; molding a plunger of an essentially firm material comprising: providing a plunger mold, injecting a melted polymeric resin into the plunger mold; molding a nexus part of an essentially firm material comprising: providing a nexus part mold, injecting a melted polymeric resin into the nexus part mold; pre-manufacturing a piston of an essentially resilient material, in which the piston comprising at least one structural element configured for attachment to the structural element of the nexus part; assembling the syringe device comprising: firmly attaching the piston to the nexus part, thereby sustaining exerting of a substantial pulling force onto the plunger, whilst the piston remains firmly attached to the nexus part, and, mounting the nexus part onto a distal portion of the elongated shaft of the plunger; inserting the piston into the tube.

[0016] In accordance with some embodiments and aspects of the present invention,there is provided a method of manipulating a biological material within a syringe device comprises the steps of: providing a syringe device; drawing the plunger outwardly from the syringe tube; collecting a sample of a biological material within the syringe tube; providing an access to throughout aperture in from a proximal side of the nexus part; inserting at least one needle, from a proximal side of the nexus part, vis the throughout aperture and through the piston; manipulating the sample of the biological material within the syringe tube by interacting with the biological material via the needle.DEFINITIONS

[0017] The term matching or a term similar thereto, as referred to herein, is to be construed as having a cross-sectional area and / or shape of a component equal or essentially similar to a cross-sectional area and / or shape of another component. It should be acknowledged that the components may only to be similar in the cross-sectional areas and / or shapes, to satisfy the term matching or similar, so long as the cross-sectional areas of the components can be mated and / or inserted into each other and / or the combination thereof essentially fits together and / or occupy essentially the same space.

[0018] The term structured, as referred to herein, is to be construed as including any geometrical shape, exceeding in complexity a plain linear shape or a shape embodying a simple and / or standardized circular, elliptical or polygonal contour or profile. Any more complex shape than a plain linear shape or a shape embodying a simple and / or standardized circular, elliptical or polygonal contour or profile, constitutes an example of structured geometry.

[0019] The term modular, as referred to herein, should be construed as a including a stand-alone and / or autonomically functioning of structured unit. The term modular inter alia means a standardized unit that may be conveniently installed or deployed without significant impact to the environment. The term modular, however, doesn’t necessarily mean providing for ease of interchange or replacement. The term modular is optionally satisfied solely by providing for ease of onetime deployment or installation.

[0020] The term readily connectable, as referred to herein, should be construed as including any structure and / or member that is configured to be conveniently connected to other structure and / or member and / or components of a larger system or assembly. The term readily connectable, however, doesn’t necessarily mean readily disconnectable or removable and vice versa. The term readily connectable is optionally satisfied by providing for ease of onetime connection or coupling.

[0021] The term fastener or a term similar thereto, as referred to herein, is to be construed as any suitable structure, material and / or device that effects an attachment, mounting and / or affixing, in a non-limiting manner including the examples of: bolts, screws, staples, pins, clips, magnetic couplings, zippers, snaps, magnets, non-permanent adhesives, adhesives, welding, nails, rivets, buckles, straps, stings, knots, hook and loop fasteners such as VELCRO (RTM), which is a trademark registered to Velcro Industries B.V.

[0022] The term biasing means or alike, as referred to herein, should be construed as including any material, structure or mechanism, configured to accumulate mechanical energy, by changing the configuration thereof, upon a force exerted thereon, such as a compressive, tensile, shear or torsional force, as well as for releasing the energy accumulated therein, by returning to the normal or default configuration thereof and thereby performing a mechanical work, typically by linear or radial displacement. Examples of biasing means in a non-limiting manner include, springs, elastomers, leaf-springs, coilsprings, tension / extension spring, compression spring torsion spring, constant spring, variable spring, variable stiffness spring, flat spring, machined spring, serpentine spring, garter spring, cantilever spring, helical spring, hollow tubing springs, volute spring, V-spring, belleville washer or belleville spring, constant-force spring, gas spring, mainspring, negator spring, progressive rate coil springs, rubber band, spring washer and wave spring.

[0023] By operationally connected and operably coupled or similar terms used herein is meant connected in a specific way (e.g., in a manner allowing fluid to move and / or electric power or signal to be transmitted) that allows the disclosed system and its various components to operate effectively in the manner described herein.

[0024] The term fluid or liquid, as referred to herein, is to be construed as any material that deforms when a shear stress is applied. While fluid generally would refer to any liquids or gases, it may be used herein to describe fluidized solids and bulk solids and / or granulate matter that are capable of flowing or otherwise moving inside a device as a result of pressure differences and / or gravitational force. Such materials may include slurries, suspensions, pastes, powders, granular solids, particle solids, granulate matter, particulate matter, as well as any combinations thereof.

[0025] The term dry powder, as referred to herein, may include any substance comprising one or a plurality of constituents or ingredients with one or a plurality of (average) particulate size ranges. The term low-density dry powder means dry powders having a density of about 0.8 gram per cubic centimeter or less. In particular embodiments, the low-density powder may have a density of about 0.5 gram per cubic centimeter or less. The dry powder may be with or without cohesive or agglomeration tendencies.

[0026] The terms firm rigid, or stiff, as referred to herein, are to be construed as having rigidity modulus value, otherwise referred to as the shear modulus, of 4800 MPa or more. Materials are considered to be firm rigid, or stiff but not tensile, when such materials are incapable of being efficiently elastically flexed or bent. Stiff materials, such as steel, are defined as having rigidity modulus value well exceeding 4800 MPa.

[0027] The terms pliable or pliant, as referred to herein, are to be construed as having high tensile strength and capable of being efficiently elastically flexed or bent but not being resilient and incapable of being efficiently stretched or expanded. The term tensile or tensile strength, as referred to herein, is to be construed inter alia as a shortcut of the known term ultimate tensile strength, frequently represented acronym as UTS, meaning an intensive property of a material or structure to withstand loads tending to elongate, namely to resist tension, defined as the maximum stress that a material can withstand while been stretched or pulled before sustaining breaking, substantial deformation and / or necking before fracture, such as nylon, relating to essentially non-ductile materials, having UTS value ranging between about 600 and 1000 MPa or more, but not including rigid, firm or stiff materials.

[0028] The terms elastic or resilient, as referred to herein, are to be construed as having tensile strength lower than aforesaid tensile strength of pliable or pliant material and optionally being capable of efficiently stretching or expanding, relating inter alia to essentially ductile materials, having UTS value lesser than about 600 MPa.

[0029] The term slurry, as referred to herein, is to be construed as a mixture of solids denser than water suspended in liquid, usually water. Solids concentrations in a slurry typically range between about 0.5 percent and about 5 percent.

[0030] The terms method and process as used herein are to be construed as including any sequence of steps or constituent actions, regardless of a specific timeline for the performance thereof. The particular steps or constituent actions of any given method or process are not necessarily in the order they are presented in the claims, description or flowcharts in the drawings, unless the context clearly dictates otherwise. Any particular step or constituent action included in a given method or process may precede or follow any other particular step or constituent action in such method or process, unless the context clearly dictates otherwise. Any particular step or constituent action and / or a combination thereof in any method or process may be performed iteratively, before or after any other particular step or action in such method or process, unless the context clearly dictates otherwise.Moreover, some steps or constituent actions and / or a combination thereof may be combined, performed together, performed concomitantly and / or simultaneously and / or in parallel, unless the context clearly dictates otherwise. Moreover, some steps or constituent actions and / or a combination thereof in any given method or process may be skipped, omitted, spared and / or opted out, unless the context clearly dictates otherwise.

[0031] In the specification or claims herein, any term signifying an action or operation, such as: a verb, whether in base form or any tense, gerund or present / past participle, is not to be construed as necessarily to be actually performed but rather in a constructive manner, namely as to be performed merely optionally or potentially.

[0032] The term substantially as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to being largely but not necessarily entirely of that quantity or quality which is specified.

[0033] The term essentially means that the composition, method or structure may include additional ingredients, stages and or parts, but only if the additional ingredients, the stages and / or the parts do not materially alter the basic and new characteristics of the composition, method or structure claimed.

[0034] As used herein, the term essentially changes a specific meaning, meaning an interval of plus or minus ten percent (± 10%). For any embodiments disclosed herein, any disclosure of a particular value, in some alternative embodiments, is to be understood as disclosing an interval approximately or about equal to that particular value (i.e., ± 10%).

[0035] As used herein, the terms about or approximately modify a particular value, by referring to a range equal to the particular value, plus or minus twenty percent (+ / -20%). For any of the embodiments disclosed herein, any disclosure of a particular value, can, in various alternate embodiments, also be understood as a disclosure of a range equal to about that particular value (i.e. + / -20%).

[0036] As used herein, the term or is an inclusive or operator, equivalent to the term and / or, unless the context clearly dictates otherwise; whereas the term and as used herein is also the alternative operator equivalent to the term and / or, unless the context clearly dictates otherwise.

[0037] It should be understood, however, that neither the briefly synopsized summary nor particular definitions hereinabove are not to limit interpretation of the invention to the specific forms and examples but rather on the contrary are to cover all modifications,equivalents and alternatives falling within the scope of the invention.DESCRIPTION OF THE DRAWINGS

[0038] The present invention will be understood and appreciated more comprehensively from the following detailed description taken in conjunction with the appended drawings in which:

[0039] FIG 1 is a perspective view of a syringe device with plunger having axially biased detents, according to some embodiments of the present invention;

[0040] FIG 2A is an exploded view of the syringe device with plunger having axially biased detents, according to some embodiments of the present invention;

[0041] FIG 2B is an enlarged view of a detent assembly of the syringe device, according to some embodiments of the present invention;

[0042] FIG 3 is a flowchart of a process of manufacturing a syringe device with plunger having axially biased detents, according to some embodiments of the present invention;

[0043] FIG 4 is a flowchart of a method of harvesting biological material, according to some embodiments of the present invention;

[0044] FIG 5 is a flowchart of an exemplary procedure of bone marrow harvesting with the syringe device, according to some embodiments of the present invention;

[0045] FIG 6 is a flowchart of an exemplary procedure of bone marrow concentration with the syringe device, according to some embodiments of the present invention.

[0046] FIG 7 is a front perspective view of a syringe device with plunger having a piston characterized by having an access aperture, according to some embodiments of the present invention;

[0047] FIG 8A is a front perspective view of a plunger of the syringe device with piston characterized by having an access aperture, according to some embodiments of the present invention;

[0048] FIG 8B is an enlarged front view of a nexus part of the plunger of the syringe device, according to some embodiments of the present invention;

[0049] FIG 9A is a rear perspective view of a plunger of the syringe device with piston characterized by having an access aperture, according to some embodiments of the present invention;

[0050] FIG 9B is an enlarged rear view of a nexus part of the plunger of the syringe device, according to some embodiments of the present invention;

[0051] FIG 10 is a flowchart of a process of manufacturing a syringe device with plunger characterized by piston having an access aperture, according to some embodiments of the present invention;

[0052] FIG 11 is a flowchart of a method of using the syringe device with plunger characterized by piston having an access aperture, for manipulating a biological material within a syringe device, according to some embodiments of the present invention.

[0053] The drawings are not necessarily complete and components are not entirely to scale; emphasis instead being placed upon clearly illustrating the principles underlying the present invention.DETAILED DISCLOSURE OF EMBODIMENTS

[0054] Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of actual implementation are described in this specification. It should be appreciated that various features or elements described in the context of some embodiment may be interchangeable with features or elements of any other embodiment described in the specification. Moreover, it will be appreciated that for the development of any actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with technology- or business- related constraints, which may vary from one implementation to another, and the effort of such a development might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0055] In accordance with some embodiments of the present invention, reference is now made to FIG 1 to 2B, showing syringe device 10 with a piston characterized by having an access aperture. In some embodiments, syringe device 10 comprises syringe tube 12. Syringe tube 12 comprises essentially elongated cylindrical shell shaped barrel 14.

[0056] In some embodiments, syringe tube 12 further comprises frusto-conical tip 16 at distal portion 18 of essentially elongated cylindrical shell shaped barrel 14. In some embodiments, syringe tube 12 further comprises at least one finger flange 19 at proximal portion 20 of essentially elongated cylindrical shell shaped barrel 14.

[0057] In some embodiments, syringe device 10 further comprises plunger 22. Plunger 22 comprises essentially elongated shaft 24. In some embodiments, syringe device10 further comprises piston 26, disposed at distal portion 28 of elongated shaft 24. Piston 26 typically comprises at least one sealing element. At least one sealing element of piston 26 is configured for forming a sealing arrangement with an interior surface of barrel 14, whilst contiguously translatable within barrel 14, along the interior surface thereof.

[0058] In some embodiments, piston 26 of plunger 22 comprises a fastener moiety, whereas distal portion 28 of elongated shaft 24 comprises respective fastener moiety 29, whereby piston 26 of plunger 22 is controllably connectable and disconnectable to and from distal portion 28 of elongated shaft 24. In some examples, the fastener moiety of piston 26 of plunger 22 and / or fastener moiety 29 at distal portion 28 of elongated shaft 24 comprise / s a screw threading.

[0059] In some embodiments, plunger 22 further comprises thumb rest 32 at proximal portion 30 of elongated shaft 24. Thumb rest 32 is configured for exerting a manual pressing force, onto plunger 22. In some embodiments, plunger 22 further comprises at least one recess 34 in essentially elongated shaft 24 thereof. At least one recess 34 comprises an interior void volume. The interior void volume is oriented essentially orthogonally in the direction of arrow 36 to longitudinal centerline 38 of essentially elongated shaft 24 of plunger 22.

[0060] In some embodiments, syringe device 10 further comprises at least one detent assembly 40. At least one detent assembly 40 comprises stopper element 42. Stopper element 42 is accommodatable within at least one recess 34 in essentially elongated shaft 24 of plunger 22. In some embodiments, stopper element 46 of at least one detent assembly 40 is axially translatable within at least one recess 34 essentially orthogonally to longitudinal centerline 38 of essentially elongated shaft 24 of plunger 22.

[0061] In some embodiments, stopper element 42 comprises structured top surface 43. Structured top surface 43 of stopper element 42 exemplarily comprises elevation 45 at a distal portion thereof.

[0062] In some embodiments, at least one detent assembly 40 further comprises a plurality or pair of detent assemblies, wherein a first detent assembly is disposed towards distal portion 28 of elongated shaft 24 of plunger 22 and a second detent assembly is disposed towards proximal portion 30 of elongated shaft 24 of plunger 22.

[0063] In some embodiments, at least one detent assembly 40 further comprises biasing means 44. Biasing means 44 is configured for spontaneously driving stopper element 42 outwardly from at least one recess 34 in essentially elongated shaft 24 of plunger22. Biasing means 44 is configured for spontaneously driving stopper element 42 outwardly from at least one recess 34 in essentially elongated shaft 24 of plunger 22, in the direction of arrow 36 essentially orthogonally to longitudinal centerline 38 of essentially elongated shaft 24 of plunger 22

[0064] In some embodiments, at least one detent assembly 40 further comprises retaining element 46. Retaining element 46 is configured for restricting a movement of stopper element 42 within at least one recess 34 in essentially elongated shaft 24 of plunger 22, thereby preventing stopper element 42 from leaving at least one recess 34. In some examples, retaining element 46 is a pawl and / or notch and / or recess and / or groove.

[0065] In some embodiments, retaining element 46 forms an integral part of essentially elongated shaft 24 of plunger 22 and of stopper element 42. In some embodiments, retaining element 46 is a combination of elements forming an integral part of essentially elongated shaft 24 of plunger 22 and / or of stopper element 42.

[0066] In accordance with some embodiments of the present invention, reference is now made FIG 3 showing a flowchart of process 100 of manufacturing a syringe device with plunger having axially biased detents. The process of the embodiment of FIG 3 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification.

[0067] In some embodiments, process 100 commences at step 102 of premanufacturing or otherwise procuring a syringe tube, such as syringe tube 12 shown in FIG 1. The syringe tube typically comprises an essentially elongated cylindrical shell shaped barrel, a frusto-conical tip and at least one finger flange, such as essentially elongated cylindrical shell shaped barrel 14, frusto-conical tip 16 and at least one finger flange 20 shown in FIG 1.

[0068] In some embodiments, process 100 further proceeds to step 104 of molding a plunger. Step 104 includes a step of providing or shaping a plunger mold. In some embodiments, the plunger mold embodies a shape of an essentially elongated shaft, with a distal portion of the elongated shaft, such as essentially elongated shaft 24 with distal portion 28 shown in FIG 1. In some embodiments, the plunger mold further embodies a shape of a thumb rest at a proximal portion of the elongated shaft, such as thumb rest 32 shown in FIG 1.

[0069] In some embodiments, the plunger mold further embodies a shape of at least one recess in the essentially elongated shaft of the plunger, such as at least one recess 34shown in FIG 1, and of at least one structural retaining element configured for restricting the movement of a stopper element within at least one recess. In some embodiments, step 104 of molding a plunger further includes injecting a melted polymeric resin into the plunger mold.

[0070] In some embodiments, process 100 further comprises step 106 of premanufacturing a piston, such as piston 26 shown in FIG 1. The piston comprises at least one sealing element, configured to form a sealing arrangement with an interior surface of the barrel, whilst contiguously translatable therein. In some embodiments, process 100 further includes step 108 of mounting the piston onto the distal portion of the elongated shaft of the plunger.

[0071] In some embodiments, process 100 further includes step 110 of molding a stopper element, such as stopper element 42 shown in FIG 1. In some embodiments, step 110 comprises providing a stopper mold embodying a shape of at least one stopper element accommodatable within at least one recess in the essentially elongated shaft of the plunger. The stopper element further embodies a shape of at least one structural retaining element, such as retaining element 46 shown in FIG 2B, configured for restricting the movement of the stopper element within at least one recess in the essentially elongated shaft of the plunger. In some embodiments, step 110 further includes injecting a melted resin into the stopper mold.

[0072] In some embodiments, process 100 further comprises step 112 of premanufacturing a biasing means, such as biasing means 44 shown in FIG 2B. The biasing means configured for spontaneously driving the stopper element outwardly from at least one recess in the essentially elongated shaft of the plunger. In some embodiments, the stopper element of at least one detent assembly is axially translatable within at least one recess, in a direction essentially orthogonal to the longitudinal centerline of the essentially elongated shaft of the plunger.

[0073] In some embodiments, process 100 further includes step 114 of assembling at least one detent assembly, such as detent assembly 40 shown in FIG 2B. In some embodiments, step 114 includes inserting the biasing means into at least one recess in the essentially elongated shaft of the plunger and inserting the stopper element into at least one recess in the essentially elongated shaft of the plunger.

[0074] In some embodiments, step 114 further includes securing the stopper element within at least one recess in the essentially elongated shaft of the plunger, by forming an operational connection between at least one structural retaining element of the recess in theessentially elongated shaft of the plunger and at least one structural retaining element of the stopper element, thereby restricting a movement of the stopper element within at least one recess and thereby preventing the stopper element from leaving at least one recess in the essentially elongated shaft of the plunger.

[0075] In accordance with some embodiments of the present invention, reference is now made FIG 4 showing a flowchart of method 200 of harvesting a biological material, such as mammalian fat or any other fatty, fatuous or soft tissue. The method of the embodiment of FIG 4 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification.

[0076] In some embodiments, method 200 commences at step 202 of providing a syringe device. The syringe device comprises a syringe tube, such as syringe tube 12 shown in FIG 1. The syringe tube comprises an essentially elongated cylindrical shell shaped barrel, and at least one finger flange, at a proximal portion of the barrel, configured for manual grip, such as essentially elongated cylindrical shell shaped barrel 14 and at least one finger flange 20 shown in FIG 1 .

[0077] In some embodiments, the syringe device further includes a plunger, such as plunger 22 shown in FIG1. The plunger comprises an essentially elongated shaft, such as essentially elongated shaft 24 shown in FIG 1, and a piston, such as piston 26 shown in FIG 1, at a distal portion of the elongated shaft, comprising at least one sealing element, configured to form a sealing arrangement with an interior surface of the barrel, whilst contiguously translatable therein.

[0078] In some embodiments, the piston of the plunger comprises a fastener part, whereas the distal portion of the elongated shaft comprises a respective fastener part, rendering the piston of the plunger controllably connectable to and disconnectable from the distal portion of the elongated shaft of the plunger, configured for controllably connecting and disconnecting the piston of the plunger to and from the distal portion the said elongated shaft of the plunger.

[0079] In some embodiments, the plunger further includes a thumb rest, such as thumb rest 32 shown in FIG 1, at a distal portion of the elongated shaft, configured for exerting a manual pressing force, onto the plunger. In some embodiments, the plunger further comprises at least one recess, such as recess 34 shown in FIG 1, in the essentially elongated shaft of the plunger, where the recess comprises an interior void volume, oriented essentially orthogonally to a longitudinal centerline of the essentially elongated shaft of the plunger.

[0080] In some embodiments, the syringe device further includes at least one detent assembly, such as at least one detent assembly 40 shown in FIG 2B. At least one detent assembly comprises a stopper element, such as stopper element 42 shown in FIG 2B, accommodatable within at least one recess in the essentially elongated shaft of the plunger.

[0081] In some embodiments, at least one detent assembly further includes a biasing means, such as biasing means 44 shown in FIG 2B, configured for spontaneously driving the stopper element outwardly from at least one recess in the essentially elongated shaft of the plunger. In some embodiments, at least one detent assembly further includes at least one retaining element, such as retaining element 46 shown in FIG 2B, configured for restricting a movement of the stopper element within at least one recess in the essentially elongated shaft of the plunger, thereby preventing the stopper element from leaving at least one recess.

[0082] In some embodiments, method 200 proceeds to step 204 of inserting a tip of a harvesting utensil into a target biological tissue, such as the subcutaneous adipose tissue. In some embodiments, method 200 further comprises step 206 of connecting the frusto- conical tip of the syringe tube, to the harvesting utensil.

[0083] In some embodiments, method 200 further includes step 208 of creating a negative pressure within the syringe tube, whilst the tip of the harvesting utensil is disposed within the target biological tissue. In some embodiments, method 200 comprises step 210 of drawing the plunger outwardly from the syringe tube. In some embodiments, step 208 of creating a negative pressure within the syringe tube is performed by drawing the plunger outwardly from the syringe tube at step 210. In some embodiments, step 208 of creating a negative pressure within the syringe tube and / or step 210 of drawing the plunger outwardly from the syringe tube is / are performed subsequently to step 204 of inserting a tip of a harvesting utensil into a target biological tissue and step 206 of connecting the frusto-conical tip of the syringe tube, to the harvesting utensil.

[0084] In some embodiments, method 200 further comprises step 212 of axially translating the stopper element by the biasing means, outwardly from at least one recess in the essentially elongated shaft of the plunger from, in the direction essentially orthogonal to the longitudinal centerline of the essentially elongated shaft of the plunger. In some embodiments, method 200 further includes step 214 of restricting by the retaining element the movement of the stopper element outwardly from at least one recess in the essentially elongated shaft of the plunger.

[0085] In some embodiments, method 200 further comprises step 216 of releasingthe plunger. The releasing of the plunger at step 216 is performed subsequently to the axially translating the stopper element, thereby sustaining the negative pressure within the syringe tube. In some embodiments, method 200 further includes step 218 of manipulating the tip of the harvesting utensil within the target biological tissue, whilst the negative pressure is maintained within the syringe tube, thereby harvesting the biological material.

[0086] In some embodiments, if the negative pressure during the harvesting procedure is accidently or inadvertently lost, such as due to disconnection of the tubing or exposure of tip of the harvesting utensil to the ambient environment, method 200 further comprises: firstly detaching the syringe device from the harvesting utensil; secondly exerting manual force onto the stopper element and pushing it in the downward direction; thirdly urging the plunger in the forward direction, so as to remove any air that has entered to the syringe device; fourthly attaching the syringe device back to the harvesting utensil, after the tip of harvesting utensil has been inserted into and / or buried within in the target tissue; fifthly re-performing the aforesaid steps, form step 208 of creating a negative pressure and onwards.

[0087] FIG 5 illustrates another embodiment of the invention. Method 300 of the embodiment of FIG 5 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification. Method 300 of the embodiment of FIG 5 provides for an exemplary procedure of bone marrow harvesting with the syringe device shown in FIG 1 to 2B.

[0088] In some embodiments, method 300 of bone marrow harvesting with the syringe device comprises step 302 of inserting a tip of a harvesting utensil into the iliac crest. In some examples, the harvesting utensil is an aspiration needle. In some embodiments, once the tip of a harvesting utensil is in the correct position, method 300 further includes step 304 of connecting the frusto-conical tip of the syringe tube to the bone marrow harvesting utensil. In some examples, the syringe tube contains heparin.

[0089] In some embodiments, method 300 comprises step 306 of creating a negative pressure within the syringe tube, by drawing a plunger outwardly from the syringe tube, whilst the tip of the bone marrow harvesting utensil is disposed within the iliac crest. In some embodiments, method 300 further proceeds to step 308 of drawing the plunger outwardly from the syringe tube, thereby reaching a first desired volume of the bone marrow.

[0090] In some embodiments, method 300 further proceeds to step 310 of axially translating by a biasing means the stopper element of a first detent assembly disposed towards a distal portion of an essentially elongated shaft of the plunger, outwardly from afirst recess in the essentially elongated shaft of the plunger from, in a direction essentially orthogonal to a longitudinal centerline of the essentially elongated shaft of the plunger.

[0091] In some embodiments, method 300 further proceeds to step 312 of restricting by a retaining element the movement of the first stopper element outwardly from the first recess in the essentially elongated shaft of the plunger. In some embodiments, method 300 further proceeds to step 314 of releasing the plunger, subsequently to the axially translating the first stopper element, thereby sustaining the negative pressure within the syringe tube.

[0092] In some embodiments, once the first desired volume of the bone marrow is harvested, method 300 proceeds to step 316 of drawing the plunger outwardly from the syringe tube, thereby reaching a second desired volume of the bone marrow.

[0093] In some embodiments, method 300 further proceeds to step 318 of axially translating a second stopper element by a biasing means of a second detent assembly disposed towards a proximal portion of an essentially elongated shaft of the plunger, outwardly from a second recess in the essentially elongated shaft of the plunger from, in a direction essentially orthogonal to a longitudinal centerline of the essentially elongated shaft of the plunger.

[0094] In some embodiments, method 300 further proceeds to step 320 of restricting by a retaining element the movement of the second stopper element outwardly from the second recess in the essentially elongated shaft of the plunger. In some embodiments, method 300 further proceeds to step 322 of releasing the plunger, subsequently to the axially translating the second stopper element, thereby sustaining the negative pressure within the syringe tube.

[0095] In some embodiments, method 300 further proceeds to step 324 of manipulating the tip of the bone marrow harvesting utensil within the iliac crest, whilst maintaining the negative pressure within the syringe tube, thereby harvesting the bone marrow.

[0096] FIG 6 illustrates yet another embodiment of the invention. Method 400 of the embodiment of FIG 6 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification. Method 400 of the embodiment of FIG 6 provides for an exemplary procedure of bone marrow concentration with the syringe device shown in FIG 1 to 2B.

[0097] In some embodiment, method 400 commences at step 402 of providing at least one harvested bone marrow syringe device, such as by a means of method 300 shownin FIG 5. In some embodiments, method 400 proceeds to step 404 of drawing a plunger outwardly from a syringe tube of at least one syringe device, while sealing the syringe tube with a sealing element of the plunger.

[0098] In some embodiments, method 400 proceeds to step 406 of placing the harvested bone marrow syringe tube within at least one syringe device into a centrifuge and centrifuging it, thereby forming an upper fraction and a lower fraction. In some examples, the harvested bone marrow syringe tube is placed into a centrifuge for a desired number of times and at a desired centrifugal force, forming an upper fraction containing undesired components and a lower fraction containing desired components.

[0099] In some embodiments, method 400 proceeds to step 408 of removing from the syringe tube the undesirable fraction, such as a cell free plasma. In some examples, step 408 includes inserting a tip of a harvesting utensil connected to another syringe tube, thereby collecting the cell free plasma.

[0100] In some embodiments, method 400 proceeds to step 410 of collecting the desired fraction from the syringe tube. In some examples, step 410 includes inserting a tip of a harvesting utensil through the sealing element of the syringe tube, thereby collecting the buffy coat and leaving the red blood cells formed in the bone marrow in the syringe tube.

[0101] In some examples, method 400 comprises a step of transferring the harvested bone marrow contained into the syringe tube, to a separation gel tube, by connecting the syringe device to a tip of a harvesting utensil and inserting it through a separation gel tube rubber stopper. In some examples, method 400 comprises a step of placing the separation gel tube containing the harvested bone narrow in a centrifuge for separation. In some embodiments, method 400 further proceeds to a step of removing the undesirable components, such as platelet poor plasma, and resuspending the desired components, such as red blood cells formed in the bone marrow, on top of the gel. In some embodiments, method 400 further proceed to a step of collecting the red bloods cells from the fraction below the gel.

[0102] In accordance with some preferred embodiments, reference is now made to FIG 7 to 9B, showing syringe device 500 with a plunger piston characterized by having an access aperture. In some embodiments, syringe device plunger 500 comprises syringe tube 502. Syringe tube 502 typically comprises essentially elongated cylindrical shell shaped barrel 504.

[0103] In some embodiments, syringe tube 502 further comprises frusto-conical tip506, such as a Luer tip or Luer taper with or without Luer-lock fitting, at distal portion 508 of barrel 502. In some embodiments, syringe tube 502 further comprises at least one finger flange 509 at proximal portion 510 of barrel 504. At least one finger flange 509 is typically configured for manual grip.

[0104] In some embodiments, syringe device plunger 500 comprises plunger 512. Plunger 512 comprises essentially elongated shaft 514. Essentially elongated shaft 514 is typically made of essentially firm material.

[0105] In some embodiments, plunger 512 further comprises thumb rest 516, at proximal portion 518 of elongated shaft 514. Thumb rest 516 is configured for exerting a manual force, onto plunger 512.

[0106] In some embodiments, plunger 512 further comprises piston 520. Piston 520 is disposed at distal portion 522 of plunger 512. In some embodiments, piston 520 is made of an essentially resilient material, configured to form a sealing arrangement with an interior surface of barrel 504, whilst contiguously translatable alongside thereof. In some embodiments, piston 520 further comprises at least one structural element 524 configured for attachment to a matching structural element.

[0107] It should be acknowledged that manufacturing piston 520 of an essentially resilient material facilitates the piercing or otherwise introducing needles and / or other pointed tools and / or utensils through piston 520, as well as optionally spontaneously sealing of the orifice, through which such a needle and / or pointed tool / utensil, after the needle and / or pointed tool / utensil has been withdrawn. Moreover, manufacturing piston 526 of an essentially resilient material further facilitates the forming a sealing arrangement with an interior surface of barrel 504.

[0108] In some embodiments, plunger 512 further comprises nexus part 526. Nexus part 526 is disposed in-between piston 520 and plunger 512. In some embodiments, nexus part 526 is made of an essentially firm material configured to firmly attach piston 520 to nexus part 526, thereby sustaining the exertion of a substantial pulling force onto nexus part 526 plunger 512, whilst piston 520 remains firmly attached to nexus part 526.

[0109] In some embodiments, nexus part 526 comprises at least one structural element 528, configured for firmly attaching piston 520 to nexus part 526. In some embodiments, structural element 528 of nexus part 526 matches at least one structural element 524 of piston 520. In some embodiments, nexus part 526 comprises at least one structural element 528, matching to at least one structural element 524 of piston 520.

[0110] In some embodiments, the remaining of piston 520 firmly attached to nexus part 526 further comprises essentially preventing a rotational displacement of said piston 520 relative to nexus part 526. In some embodiments, nexus part 526 in a non-limiting manner is firmly attached to piston 520 by at least one of: structural catching, adhesives, co-molding, at least one fastener, as set forth supra, pointed tip, prong and / or pawl.

[0111] In some embodiments, at least one structural element 528 of nexus part 526 configured to firmly attach piston 520 to nexus part 526 comprises circumferential groove 530, matching to at least one structural element 524 of piston 520. In other embodiments, at least one structural element 528 of nexus part 526 comprises a plurality of dowels and / or prongs. In some embodiment, at least one structural element 524 of piston 520 configured to firmly attach piston 520 to nexus part 526 comprises circumferential rim 532, matching at least one structural element 528 of nexus part 526.

[0112] In some embodiments, nexus part 526 forms throughout aperture 534. Aperture 534 is configured to facilitate an access to the interior of syringe device 500, from a proximal face of piston 520. It should be acknowledged that manufacturing nexus part 526 of an essentially firm material does not sustain the piercing or otherwise introducing needles and / or other pointed tools and / or utensils nexus part 526, other than via throughout aperture 534.

[0113] In some embodiments, nexus part 526 further comprises fastener element 536, whereas distal portion 522 of elongated shaft 514 comprises a respective fastener element 538, whereby nexus part 526 is rendered readily connectable to and disconnectable from distal portion 522 of elongated shaft 514 of plunger 512. In some examples, fastener elements 536 and 538 comprise a matching screw threading.

[0114] In some embodiments, plunger 512 further comprises at least one detent assembly 540. Detent assembly 540 comprises stopper element 542, accommodatable within at least one recess 544 in essentially elongated shaft 514 of plunger 512.

[0115] In some embodiments, detent assembly 540 further comprises a biasing means. The biasing means is configured for spontaneously driving stopper element 542 outwardly from at least one recess 544 in essentially elongated shaft 514 of plunger 512.

[0116] In some embodiments, detent assembly 540 further comprises at least one retaining element. At least one retaining element is configured for restricting a movement of stopper element 542 within at least one recess 544 in essentially elongated shaft 514 of plunger 512, thereby preventing stopper element 542 from leaving at least one recess 544.

[0117] In some embodiments, stopper element 542 of at least one detent assembly 540 is axially translatable within at least one recess 544, in a direction essentially orthogonal to longitudinal centerline 546 of essentially elongated shaft 514 of plunger 512.

[0118] In accordance with some embodiments of the present invention, reference is now made FIG 10 showing a flowchart of process 600 of manufacturing a syringe device with piston characterized by having an access aperture. Process 600 of the embodiment of FIG 10 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification.

[0119] In some embodiments, process 600 commences at step 602 of premanufacturing a syringe tube. The syringe tube comprises an essentially elongated cylindrical shell shaped barrel, a frusto-conical tip, at a distal portion of the barrel and at least one finger flange, at a proximal portion of the barrel, configured for manual grip.

[0120] In some embodiments, process 600 further comprises step 604 of molding a plunger of an essentially firm material. In some embodiments, step 604 comprises a step of providing a plunger mold embodying a shape of an essentially elongated shaft with a thumb rest at a proximal portion of the elongated shaft, configured for exerting a manual force, onto the plunger. In some embodiments, step 604 further comprises a step of injecting a melted polymeric resin into the plunger mold.

[0121] In some embodiments, process 600 further comprises step 606 of molding a nexus part of an essentially firm material. In some embodiments, step 606 comprises a step of providing a nexus part mold embodying an essentially cylindrical shape, including at least one structural element matching the at least one structural element of a piston and a throughout aperture, configured to facilitate an access to an interior of the syringe device, from a proximal face of the piston. In some embodiments, step 606 yet further comprises a step of injecting a melted polymeric resin into the nexus part mold.

[0122] In some embodiments, process 600 further comprises step 608 of premanufacturing a piston of an essentially resilient material, in which the piston comprising at least one structural element configured for attachment to the matching structural element of the nexus part.

[0123] In some embodiments, process 600 proceeds to step 610 of assembling the syringe device. In some embodiments, step 610 comprises firmly attaching the piston to the nexus part, thereby sustaining exerting of a substantial pulling force onto the plunger, whilst the piston remains firmly attached to the nexus part. In some embodiments, step 610 yetfurther comprises a step of mounting the nexus part onto a distal portion of the elongated shaft of the plunger and a step of inserting the piston into the tube.

[0124] In accordance with some embodiments of the present invention, reference is now made FIG 11 showing a flowchart of method 700 of manipulating a biological material within a syringe device. Method 700 of the embodiment of FIG 11 illustrates various features that may be interchangeable with elements of any other embodiment described in the specification.

[0125] In some embodiments, method 700 commences at step 702 of providing a syringe device. In some embodiments, the syringe device comprises a syringe tube comprising an essentially elongated cylindrical shell shaped barrel, a frusto-conical tip, at a distal portion of the barrel, and at least one finger flange, at a proximal portion of the barrel, configured for manual grip.

[0126] In some embodiments, the syringe device further comprises a plunger comprising an essentially elongated shaft, made of an essentially firm material. The plunger further comprises a thumb rest at a proximal portion of the elongated shaft, configured for exerting a manual force, onto the plunger. The plunger further comprises a piston disposed at a distal portion of the plunger, comprising an essentially resilient material, configured to form a sealing arrangement with an interior surface of the barrel, whilst contiguously translatable alongside thereof. The piston comprises at least one structural element configured for attachment to a matching structural element.

[0127] In some embodiments, the syringe device further comprises a nexus part disposed in-between the piston and the plunger, made of an essentially firm material, configured to firmly attach the piston to the nexus part, thereby sustaining exerting of a substantial pulling force onto the plunger, whilst the piston remains firmly attached to the nexus part. The nexus part comprising at least one structural element matching the at least one structural element of the piston.

[0128] In some embodiments, the nexus part comprises a fastener element, whereas the distal portion of the elongated shaft comprises a respective fastener element, rendering the piston of the plunger controllably connectable to and disconnectable from the distal portion of the elongated shaft of the plunger. The fastener optionally comprises a screw threading.

[0129] In some embodiments, the syringe device further comprises throughout aperture formed in the nexus part, configured to facilitate an access to an interior of thesyringe device, from a proximal face thereof.

[0130] In some embodiments, method 700 proceeds to step 704 of drawing the plunger outwardly from the syringe tube. In some embodiments, method 700 further comprises step 706 of collecting a sample of a biological material within the syringe tube.

[0131] In some embodiments, method 700 further proceeds to step 708 of providing an access to throughout aperture in from a proximal side of the nexus part. In some embodiments, method 700 yet further proceeds to step 710 of inserting at least one needle to the interior of the syringe device, from a proximal side of the nexus part, via the throughout aperture and through the piston. In some embodiments, method 700 further comprises step 712 of manipulating the sample of the biological material within the syringe tube by, interacting with the biological material via the needle. Step 712 optionally includes the withdrawing of liquids from the interior of the syringe and / or the injecting of liquids into the interior of the syringe.WORKING EXAMPLES

[0132] Example 1 - Exemplary procedure of bone marrow harvesting with the syringe device

[0133] In a first working example, a standard bone marrow aspiration needle was inserted into the iliac crest of a patient. Once aspiration needle was in the correct position, the frusto-conical tip of a syringe tube, of standard 20 cc volume, which contained heparin, was connected to the bone marrow aspiration needle.

[0134] A negative pressure has then been created within the syringe tube, by drawing the plunger of the syringe device outwardly from the syringe tube, while the tip of the bone marrow aspiration needle remained within the iliac crest. The plunger was removed outwardly from the syringe tube, reaching a first volume of 10 cc of bone marrow.

[0135] Subsequently to that, a first stopper element has then been translated by a biasing means of a first detent assembly disposed towards a distal portion of an essentially elongated shaft of the plunger, outwardly from a first recess in the essentially elongated shaft of the plunger, in a direction essentially orthogonal to a longitudinal centerline of the essentially elongated shaft of the plunger.

[0136] The movement of the first stopper element outwardly from the first recess in the essentially elongated shaft of the plunger was restricted by a retaining element. Then, subsequently to the axially translating the first stopper element, the plunger was released,thereby sustaining the negative pressure within the syringe tube.

[0137] Once the first desired volume of the bone marrow has been harvested the plunger was once again pulled yet further outwardly from the syringe tube, thereby reaching a second volume of 20 cc of bone marrow. A second stopper element then has also been translated by a biasing means of a second detent assembly, disposed towards a distal portion of an essentially elongated shaft of the plunger, outwardly from a second recess in the essentially elongated shaft of the plunger from, in a direction essentially orthogonal to a longitudinal centerline of the essentially elongated shaft of the plunger.

[0138] The movement of the second stopper element was also restricted by a retaining element outwardly from the second recess in the essentially elongated shaft of the plunger. Then, subsequently to the axially translating the second stopper element the plunger was released for the second time, thereby sustaining the negative pressure within the syringe tube.

[0139] The bone marrow aspiration needle has then been further manipulated within the iliac crest, whilst sustaining the negative pressure within the syringe tube, thereby harvesting the bone marrow, util reaching a second harvested volume of 20 cc.

[0140] Example 2 - Exemplary procedure of bone marrow concentration with the syringe device

[0141] A harvested bone marrow, by a means of procedure of Example 1 , with the syringe device has been provided. Then, the plunger of the syringe device was detached from the syringe tube of the syringe device, by unscrewing the piston from the shaft of the plunger, while maintaining the syringe tube remained closed with a sealing element of the piston.

[0142] The harvested bone marrow syringe tube of the syringe device was then placed into a centrifuge for 5 minutes at 800g, forming an upper fraction containing cells free plasma and a lower fraction containing a buffy coat.

[0143] The undesirable fraction which contains cells free plasma was withdrawn from the syringe tube, by inserting a 90mm sharp needle connected to an empty regular 20ml syringe, through the sealing element of the piston, thereby collecting the upper fraction, whilst leaving approximately 1ml of plasma above the fraction of the red cells. The 20ml syringe containing the cells free plasma was thereafter detached from the 90mm sharp needle.The desired fraction was finally collected from the syringe tube, by inserting a sharp needlethrough the sealing element of a 10ml syringe, thereby collecting the buffy coat.

[0144] Example 3 - Exemplary procedure of bone marrow harvesting with the syringe device

[0145] In a third working example, lithium heparin was collected using the 10 ml syringe attached to the 21 g hypodermic needle. The needle was left in the heparin bottle, whilst only the syringe was detached, whereas the syringe was thereafter attached to the trocar, so as to flash the trocar with lithium heparin.

[0146] The trocar then was inserted in the preferred area to harvest the bone marrow, with a standard harvesting technique. The trocar was attached to the bone marrow processing syringe, including 20ml syringe with micronized acellular dermis (MACD) and a disc filter, by firstly detaching the tip cap and connecting the tip to the trocar. Then the removed tip caps have been kept sterile, to later use of closing the syringes.

[0147] Harvesting was carried out using a new 20 ml syringe containing micronized acellular dermis (MACD) and a disc filter. It was important to ensure that both the syringes were completely filled with bone marrow to facilitate equilibration during centrifugation.

[0148] The bone marrow harvesting was performed by pulling the plunger backwards to the 10ml line mark, until hearing the click of the first detent. When the click of the first detent had been heard, the plunger has been released, whilst the negative pressure remined maintained in the syringe. When the bone marrow reached the 10ml line mark, the plunger was pulled backwards again to the 20ml line mark, until hearing the click of the second detent. Then the bone marrow was allowed to reach the 20ml line mark. There after the syringe and trocar filter were detached from the syringe.

[0149] Then, each syringe containing micronized acellular dermis (MACD) and a disc filter was closed immediately after detaching from the trocar. Subsequently, the syringes with the bone marrow to be treated were handed over outside the sterile area by the on-call personnel.

[0150] The plungers were then detached from the syringes, containing micronized acellular dermis (MACD) and a disc filter, by unscrewing the screw threading of the plunger from the nexus part. Afterwards, the syringes were inserted into the centrifuge with the proper counterbalance. One time two full syringes with bone marrow and other time one syringe with bone marrow and the other in front with water to the same level of bone marrow have been used. Then, the samples were centrifuged for 3 minutes at 1200g.

[0151] Subsequently to that the syringes containing micronized acellular dermis(MACD) and a disc filter were placed on a stand. It then was checked how many milliliters of the red blood cell fraction were inside each syringe. 1ml of red fraction was left in the syringes before the second spin. The same volume of 1ml was discarded by attaching a 10ml syringe with connector and drawing down the red fraction to the 10ml syringe.

[0152] Then, the syringe containing the buffy coat and whole plasma fraction has been recapped for a second spin. The syringe with the red blood cells fraction was discarded and the operation was repeated with the second syringe containing micronized acellular dermis (MACD) and a disc filter.

[0153] The syringes containing micronized acellular dermis (MACD) and a disc filter were placed without their plungers in the centrifuge one if front of the other to counterbalance and centrifuged for 8 minutes at 1000g.

[0154] The syringes containing micronized acellular dermis (MACD) and a disc filter were then placed on the stand again. The plunger stopper was disinfected by spraying an antiseptic and was proceeded to piercing the piston via the throughout aperture, with one of the 10ml syringes attached to a 90mm sharp needle. After ensuring that the needle tip was not in or near the buffy coat, the needle tip was held in the upper bone marrow-poor plasma fraction and the bone marrow-poor plasma fraction was withdrawn, leaving a total of approximately 3ml of biological material in the syringe. Then, the operation was repeated with the second syringe containing micronized acellular dermis (MACD) and a disc filter.

[0155] The two syringes were then connected by a female-to-female connector and their contents gently transferred from one side to the other 5 times in a row. So as to break up and wash the bone marrow mesenchymal stromal cell (BMSC) pellet. The entire ~6ml of bone marrow concentrate was finally stored in one of the syringes and transported to the sterile area.

[0156] To deliver in a sterile way, the sterile personnel were equipped with a sterile 10ml syringe and female to female connector, to transfer the bone marrow concentrate from the syringe containing micronized acellular dermis (MACD) and a disc filter) to a sterile 10ml syringe. Then, the bone marrow concentrate was ready for use.

[0157] It will be appreciated by persons skilled in the art of the invention that various features and / or elements elaborated in the context of a specific embodiment described hereinabove and / or referenced herein and / or illustrated by a particular example in a certain drawing enclosed hereto, whether method, system, device or product, is / areinterchangeable with features and / or elements of any other embodiment described in the specification and / or shown in the drawings. Moreover, skilled persons would appreciate that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the invention is defined by the claims which follow:

Claims

CLAIMS1 . A syringe device with piston characterized by having an access aperture comprises:(a) a syringe tube comprising:(I) an essentially elongated cylindrical shell shaped barrel;(II) a frusto-conical tip, at a distal portion of said barrel;(III) at least one finger flange, at a proximal portion of said barrel, configured for manual grip;(b) a plunger comprising:(I) an essentially elongated shaft, comprising an essentially firm material;(II) a thumb rest at a proximal portion of said elongated shaft, configured for exerting a manual force, onto said plunger;(III) a piston disposed at a distal portion of said plunger, comprising an essentially resilient material, configured to form a sealing arrangement with an interior surface of said barrel, whilst contiguously translatable alongside thereof, said piston comprising at least one structural element configured for attachment to a matching structural element;(IV) a nexus part disposed in-between said piston and said plunger, comprising an essentially firm material, configured to firmly attach said piston to said nexus part, thereby sustaining exerting of a substantial pulling force onto said plunger, whilst said piston remains firmly attached to said nexus part, said nexus part comprising at least one structural element matching to said at least one structural element of said piston;(V) wherein said nexus part forms a throughout aperture, configured to facilitate an access to an interior of said syringe device, from a proximal face thereof.

2. The syringe device, as in claim 1 , wherein said nexus part further comprises a fastener element, whereas said distal portion of said elongated shaft comprises a respective fastener element, whereby said nexus part is readily connectable to and disconnectable from said distal portion of said elongated shaft of said plunger.

3. The syringe device, as in claim 2, wherein said fastener comprises a screw threading.

4. The syringe device, as in claim 1 , wherein said at least one structural element of said nexus part configured to firmly attach said piston to said nexus part comprises acircumferential groove, matching to said at least one structural element of said piston.

5. The syringe device, as in claim 1 , wherein said at least one structural element of said piston configured to firmly attach said piston to said nexus part comprises a circumferential rim, matching to said at least one structural element of said nexus part.

6. The syringe device, as in claim 1 , wherein said remains firmly attached to said nexus part further comprises essentially preventing a rotational displacement of said piston relative to said nexus part.

7. The syringe device, as in claim 1 , wherein said at least one structural element of said nexus part comprises a plurality of dowels.

8. The syringe device, as in claim 1 , wherein said plunger further comprises at least one detent assembly comprising:(a) a stopper element, accommodatable within said at least one recess in said essentially elongated shaft of said plunger;(b) a biasing means, configured for spontaneously driving said stopper element outwardly from said at least one recess in said essentially elongated shaft of said plunger;(c) at least one retaining element, configured for restricting a movement of said stopper element within said at least one recess in said essentially elongated shaft of said plunger, thereby preventing said stopper element from leaving said at least one recess; wherein said stopper element of said at least one detent assembly is axially translatable within said at least one recess, in a direction essentially orthogonal to said longitudinal centerline of said essentially elongated shaft of said plunger.

9. The syringe device, as in claim 8, wherein said at least one detent assembly comprises a first detent assembly and a second detent assembly, wherein said first detent assembly is disposed towards said distal portion of said shaft, whereas said second detent assembly is disposed towards said proximal portion of said shaft.

10. The syringe device, as in claim 8, wherein said retaining element is selected from the group consisting of: a retaining element forming an integral part of said essentiallyelongated shaft of said plunger, a retaining element forming an integral part of said stopper element, an external retaining element forming no integral part of neither said essentially elongated shaft of said plunger nor said stopper element.

11. A process of manufacturing a syringe device with piston characterized by having an access aperture comprises the steps of:(a) pre-manufacturing a syringe tube comprising:(I) an essentially elongated cylindrical shell shaped barrel;(II) a frusto-conical tip, at a distal portion of said barrel;(III) at least one finger flange, at a proximal portion of said barrel, configured for manual grip;(b) molding a plunger of an essentially firm material comprising:(I) providing a plunger mold embodying a shape of:(i) an essentially elongated shaft, comprising;(ii) a thumb rest at a proximal portion of said elongated shaft, configured for exerting a manual force, onto said plunger;(II) injecting a melted polymeric resin into said plunger mold;(c) molding a nexus part of an essentially firm material comprising:(I) providing a nexus part mold embodying a shape of:(i) an essentially cylindrical shape;(ii) at least one structural element matching to at least one structural element of a piston;(iii) a throughout aperture, configured to facilitate an access to an interior of said syringe device, from a proximal face thereof;(II) injecting a melted polymeric resin into said nexus part mold;(d) pre-manufacturing a piston of an essentially resilient material, wherein said piston comprising at least one structural element configured for attachment to said structural element of said nexus part;(e) assembling said syringe device comprising:(I) firmly attaching said piston to said nexus part, thereby sustaining exerting of a substantial pulling force onto said plunger, whilst said piston remains firmly attached to said nexus part;(II) mounting said nexus part onto a distal portion of said elongated shaft of said plunger;(III) inserting said piston into said tube.

12. The process, as in claim 11 , wherein said nexus part comprises a fastener element, whereas said distal portion of said elongated shaft comprises a respective fastener element, rendering said nexus part controllably connectable to and disconnectable from said distal portion of said elongated shaft of said plunger, further comprises reversibly connecting said nexus part to said distal portion of said elongated shaft of said plunger.

13. The process, as in claim 12, wherein said fastener comprises a screw threading.

14. The process, as in claim 11 , wherein said at least one structural element of said nexus part is configured to firmly attach said piston to said nexus part, comprising a circumferential groove, matching to said at least one structural element of said piston.

15. The process, as in claim 11 , wherein said at least one structural element of said piston is configured to firmly attach said piston to said nexus part, comprising a circumferential rim, matching to said at least one structural element of said nexus part.

16. The process, as in claim 11 , wherein said firmly attaching of said piston to said nexus part further comprises essentially preventing a rotational displacement of said piston relative to said nexus part.

17. The process, as in claim 11 , wherein said mold of said at least one structural element of said nexus part comprises a shape of a plurality of dowels.

18. The process, as in claim 11 , wherein said plunger further comprises at least one detent assembly comprising:(a) a stopper element, accommodatable within said at least one recess in said essentially elongated shaft of said plunger;(b) a biasing means, configured for spontaneously driving said stopper element outwardly from said at least one recess in said essentially elongated shaft of said plunger;(c) at least one retaining element, configured for restricting a movement of said stopper element within said at least one recess in said essentially elongated shaft of said plunger, thereby preventing said stopper element from leaving said at leastone recess; wherein said stopper element of said at least one detent assembly is axially translatable within said at least one recess, in a direction essentially orthogonal to said longitudinal centerline of said essentially elongated shaft of said plunger.

19. The process, as in claim 18, wherein said at least one detent assembly comprises a first detent assembly and a second detent assembly, wherein said first detent assembly is disposed towards said distal portion of said shaft, whereas said second detent assembly is disposed towards said proximal portion of said shaft.

20. The process, as in claim 18, wherein said retaining element is selected from the group consisting of: a retaining element forming an integral part of said essentially elongated shaft of said plunger, a retaining element forming an integral part of said stopper element, an external retaining element forming no integral part of neither said essentially elongated shaft of said plunger nor said stopper element.

21. A method of manipulating a biological material within a syringe device comprises the steps of:(a) providing a syringe device comprising:(I) a syringe tube comprising: (i) an essentially elongated cylindrical shell shaped barrel; (ii) a frusto-conical tip, at a distal portion of said barrel, and (iii) at least one finger flange, at a proximal portion of said barrel, configured for manual grip;(II) a plunger comprising: (i) an essentially elongated shaft, comprising an essentially firm material; (ii) a thumb rest at a proximal portion of said elongated shaft, configured for exerting a manual force, onto said plunger; (iii) a piston disposed at a distal portion of said plunger, comprising an essentially resilient material, configured to form a sealing arrangement with an interior surface of said barrel, whilst contiguously translatable alongside thereof, said piston comprising at least one structural element configured for attachment to a matching structural element;(III) a nexus part disposed in-between said piston and said plunger, comprising an essentially firm material, configured to firmly attach said piston to said nexus part, thereby sustaining exerting of a substantial pulling force onto said plunger, whilst said piston remains firmly attached to said nexus part, said nexus part comprising at least one structural element matching to said at least one structural elementof said piston(IV) a throughout aperture formed in said nexus part, configured to facilitate an access to an interior of said syringe device, from a proximal face thereof;(b) drawing said plunger outwardly from said syringe tube;(c) collecting a sample of a biological material within said syringe tube;(d) providing an access to said throughout aperture from a proximal side of said nexus part;(e) inserting at least one needle, from a proximal side of said nexus part, vis said throughout aperture and through said piston;(f) manipulating said sample of said biological material within said syringe tube by interacting with said biological material via said needle.

22. The method, as in claim 21 , wherein said nexus part comprises a fastener element, whereas said distal portion of said elongated shaft comprises a respective fastener element, rendering said piston of said plunger controllably connectable to and disconnectable from said distal portion of said elongated shaft of said plunger, wherein providing said access to said throughout aperture further comprises controllably disconnecting said piston from said distal portion of said elongated shaft of said plunger.

23. The method, as in claim 22, wherein said wherein said fastener comprises a screw threading.

24. The method, as in claim 21 , wherein said plunger further comprises at least one detent assembly.

Images