Syringe with Integrated Vein Finder

A syringe with an integrated vein finder is disclosed, which illuminates a potential venipuncture site of a patient and identifies a vein that is suitable for venipuncture with the syringe, for blood collection or intravenous drug administration. The syringe portion of the system includes a syringe barrel and a pointed-tip needle projecting from the distal end of the barrel for venipuncture. An illumination module is coupled to the syringe barrel; it has an illumination source that projects an electromagnetic beam into an illumination zone distal the syringe's pointed tip, for illuminating and identifying a subcutaneous vein. The integrated vein finder and syringe system is operable by a sole clinician, such as a phlebotomist, who can easily manipulate the syringe and illuminate the venipuncture site with one hand, without assistance of another clinician.

TECHNICAL FIELD

The present disclosure generally relates to medical syringes with integrated illumination modules, to illuminate and in turn locate a subcutaneous vein, during venipuncture, for blood collection and/or administering drugs to a patient.

BACKGROUND

Blood-collection venipunctures are frequently performed on patients as a basic medical requirement for most diagnostic tests. While venipunctures are performed frequently by clinicians, such as phlebotomists, some patients have veins that easily collapse or roll, are too thin, or that are difficult to find. These “difficult” veins are most often associated with populations such as children or geriatric patients, but anyone can have them. Patients with difficult veins may require multiple puncture attempts as the phlebotomist attempts to identify alternative puncture sites in the same or in a different vein. Venipunctures are also performed on patients for venous drug administration, with the same challenges to clinicians for identifying veins prior to puncture.

Stationary-mounted and handheld vein finding instruments are marketed for in vitro, external illumination of subcutaneous veins. Some of these devices illuminate potential venipuncture sites of patients with electromagnetic radiation in the infra-red wavelength range. As reported by published researchers, the infra-red beam provides clinicians better visible contrast between veins and surrounding skin tissue than ambient light. The stationary-mounted devices are typically mounted on stands, which require maneuvering the patient relative to a fixed illumination field. Such devices are difficult to utilize for immobile or physically challenged patients in beds or wheelchairs. In large-scale, blood collection sites, phlebotomists test hundreds of patients daily. It would be too time consuming to move and reorient a stationary-mounted vein finding device at a large-scale blood collection site for multiple patients every day. So-called “handheld” vein finding instruments require two clinicians to operate them. A sole clinician must hold and actuate the device with one hand while stabilizing the patient with the other hand. The same clinician cannot simultaneously perform a venipuncture with a syringe because that requires one hand to manipulate the syringe and the other hand to stabilize the patient. Given the need for three hands, two clinicians work together to identify a suitable vein with the handheld vein finding device: one operates the vein finder while the other performs the venipuncture with the syringe. Similarly, during intravenous drug administration by syringe, two clinicians are required to utilize a handheld vein finding device and manipulate the syringe.

SUMMARY

In a first embodiment, a syringe with an integrated vein finder illuminates a potential venipuncture site of a patient and identifies a vein that is suitable for venipuncture with the syringe, for blood collection or intravenous drug administration. The integrated vein finder and syringe system is operable by a sole clinician, such as a phlebotomist, who can easily manipulate the syringe and illuminate the venipuncture site with one hand, while stabilizing the patient's venipuncture site with the other hand. This integrated system requires little additional clinician training and experience beyond what is needed for routine venipuncture during blood collection or intravenous drug administration. Illuminating the venipuncture site with the integrated system increases likelihood that venipuncture will be completed successfully in a single puncture, without the need to re-attempt puncture at the same or at an alternative site. This integrated system eliminates the need for a second, assisting clinician to find the vein with a separate handheld vein finding device while still reducing the likelihood of performing multiple attempts to puncture a suitable vein without use of the separate handheld device. In some embodiments the system integrates the illumination device within the syringe instrument. In other embodiments, the illumination device is a reusable illumination module that is selectively attached to different syringes as needed. In other embodiments the illumination module is selectively coupled to common, disposable, single-use syringes for blood collection or intravenous drug administration.

One aspect of the present disclosure pertains to an in vivo, subcutaneous vein finding syringe system, comprising a syringe and an illumination module. The syringe portion of the system includes a barrel having a proximal open end, a distal end, a plunger “within the barrel, translatable within the proximal open end of the barrel, and a needle projecting from the distal end of the barrel. The needle has a pointed tip for piercing a subcutaneous vein of a patient (i.e., a venipuncture). The illumination module is coupled to the syringe barrel; it has an illumination source that projects an electromagnetic beam into an illumination zone distal the syringe's pointed tip, for illuminating and identifying a subcutaneous vein of the patient to be pierced by the syringe needle.

In some embodiments, the illumination source projects an electromagnetic beam in the infra-red spectrum with a wavelength in a range from 696 nm to 1000 nm. In other embodiments, the illumination source projects an electromagnetic beam wavelength between 740 nm and 940 nm. In some embodiments the illumination source includes an LED emitter. In some embodiments, the illumination source includes one or more lenses for projecting the electromagnetic beam into the illumination zone. In some embodiments, a lens articulator is coupled to the lens for selectively reorienting the illumination zone relative to the pointed tip.

Another aspect of the disclosure pertains to an in vivo, subcutaneous vein finding syringe system, comprising a syringe and an illumination module. The syringe portion of the system includes a barrel having a proximal open end, a distal end, a plunger “within the barrel, translatable within the proximal open end of the barrel, and a needle projecting from the distal end of the barrel. The needle has a pointed tip for piercing a subcutaneous vein of a patient (i.e., a venipuncture). The illumination module has an enclosure, and an illumination source oriented in the enclosure that projects an electromagnetic beam out of the enclosure into an illumination zone distal the pointed tip, for illuminating and identifying a subcutaneous vein of the patient to be pierced by the syringe needle. The system also includes a selectively detachable mount for coupling the illumination module to the syringe barrel. In some embodiments, the detachable mount further comprises a clamp circumscribing the syringe barrel. In some embodiments, the illumination source includes one or more lenses for projecting the electromagnetic beam into the illumination zone. In some embodiments, a beam articulator is coupled to the enclosure for selectively reorienting the illumination zone relative to the pointed tip. In some embodiments the illumination source includes an LED emitter. In some embodiments, the illumination source projects an electromagnetic beam in the infra-red spectrum with a wavelength in a range from 696 nm to 1000 nm. In other embodiments, the illumination source projects an electromagnetic beam wavelength between 740 nm and 940 nm.

Other aspects of the disclosure pertain to a method for finding an in vivo, subcutaneous vein of a patient and for piercing same with a syringe needle. In practicing this method, a syringe is provided, which includes a barrel having a proximal open end and a distal end, a plunger “within the barrel, translatable within the proximal open end of the barrel, and a needle projecting from the distal end of the barrel. The provided needle has a pointed tip. A provided illumination module is coupled to the syringe barrel. The illumination module has an illumination source that projects an electromagnetic beam into an illumination zone distal the pointed tip. A single clinician selectively orients the illumination zone on a patient's body by moving the syringe; identifies a subcutaneous vein of the patient that is within the illumination zone; and pierces the identified subcutaneous vein with the syringe needle while the punctured vein remains within the illumination zone.

Some embodiments for practicing the method further comprise forming the illumination zone with a lens within in the illumination module, and selectively reorienting the illumination zone relative to the pointed tip by manipulating a lens actuator coupled to the lens, which moves the lens relative to the illumination module. Some embodiments for practicing the method comprise selectively coupling the illumination module to the syringe barrel with a clamping mechanism. Some embodiments for practicing the method further comprise projecting an electromagnetic beam wavelength in a range from 696 nm to 1000 nm into the illumination zone with the illumination source.

To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale.

DETAILED DESCRIPTION

Aspects of the vein finding syringe system, including its syringe and its illumination module embodiments disclosed herein facilitate patient venipuncture by a single clinician, such as a phlebotomist, for blood collection. The vein finding syringe system disclosed herein is also facilitates venipuncture and intravenous drug administration by a single clinician. The system disclosed herein facilitates single handed operation of both the syringe and its integrated illumination module without relying on additional clinician assistance that otherwise would be necessary to hold and position an independent, external vein finding device.

The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being conducted in many ways. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

With respect to terms used in this disclosure, the following definitions are provided. As used herein, the use of “a,” “an,” and “the” includes the singular and plural. In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a clinician.

As used herein, the term “Luer connector” refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. The Luer connector male end is generally associated with a syringe and can interlock and connect to the female end located a needle hub.

As used herein, ISO 80369-7:2016 defines a specification for standard Luer connectors including a 6% taper between the distal end and the proximal end. A male standard luer connector increases from the open distal end to the proximal end. A female standard luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, a male standard luer connector has an outer cross-sectional diameter measured 0.75 mm from the distal end of the tip of between 3.970 mm and 4.072 mm. The length of the male standard luer taper is between 7.500 mm to 10.500 mm. The outer cross-sectional diameter measured 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. As used herein, the phrases “male standard luer connector” and “female standard luer connector” shall refer to connectors having the dimensions described in ISO 80369-7, which is hereby incorporated by reference in its entirety.

As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “tip”, “hub”, “thread”, “protrusion/insert”, “tab”, “slope”, “wall”, “top”, “side”, “bottom” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.

The following non-limiting description demonstrates principles according to one or more embodiments of the disclosure. Referring now to the drawings, a first aspect of the present disclosure is shown inFIGS.1-3, wherein a vein finding syringe system10comprises a syringe12and an integrated vein illumination module28. The syringe12is manipulated by a clinician in known fashion to draw blood from or deliver medication intravenously to a subcutaneous vein19V of a patient15P (venipuncture).

The syringe12includes a barrel14having a distal end16with a male Luer connector17, and a proximal end18, which is open and configured to receive a plunger20within the barrel which is translatable within the proximal end of the barrel14. A needle hub22, which can be a female Luer connector is coupled to the male Luer connector17. A needle24is coupled to the needle hub22and is in fluid communication with a chamber defined within the barrel14. The needle projects from the distal end of the barrel and has a needle tip26for piercing or puncturing the subcutaneous vein19V of the patient15P (venipuncture). The syringe12includes visual or other indication elements27to indicate the position of a stopper (not shown) on a distal end of the plunger20.

The vein illumination module28is selectively coupled to the outer circumference of the syringe barrel14by a clamp30, with a pair of clamp jaws31which can be in the form of opposed resilient jaws. The clamp30is incorporated within an illumination module housing or module enclosure32. In other embodiments, the clamp30is selectively removeable from the module enclosure32. In other embodiments, the clamp jaws31are selectively biased toward each other by a clamp screw (not shown). A light enclosure34is coupled to the module enclosure32and transmits an electromagnetic beam into an illumination zone21Z distal the needle tip26. The electromagnetic beam is generated by an illumination source within the module enclosure32. In some embodiments, the light enclosure34incorporates the illumination source therein. The illumination source illuminates and identifies a subcutaneous vein19V of the patient15P, which is to be pierced by the needle24. The module enclosure32incorporates an articulation mechanism and its articulation knob36, which can be externally actuated, shown as a track ball, which articulates the illumination zone21Z relative to the needle tip26. In some embodiments, the articulation knob is coupled to the light enclosure34, and the articulation knob can be moved as shown by arrow36t, which causes the tilt motion T of the light enclosure. The articulation range of motion is shown as a tilt motion T relative to the tip26, but in other embodiments the articulation range of motion T is a lateral panning motion relative to the tip26. In some embodiments, the articulation range of motion includes both tilt and panning of the illumination zone21Z.

Other aspects of the disclosure are shown inFIG.4, where illumination module40has a module enclosure42with a front surface44, a rear surface46, and a bottom surface48. A female snap fitting50is incorporated in the bottom surface48of the module enclosure42. The snap fitting50selectively engages with a corresponding male snap fitting52that is affixed to the barrel54of a syringe56, as shown schematically by the arrow50S. A light enclosure34is coupled to the module enclosure42and transmits an electromagnetic beam into an illumination zone21Z distal the needle tip26. The electromagnetic beam is generated by an illumination source within the module enclosure42. In some embodiments, the light enclosure34incorporates the illumination source therein. The illumination source illuminates and identifies a subcutaneous vein of the patient, which is to be pierced by the needle24. An articulation mechanism and its articulation knob36, shown as a track ball, articulates the illumination zone relative to the needle tip26, as is done in the vein illumination module28ofFIGS.1-3. The articulation range of motion is shown as a tilt motion T relative to the needle tip26, but in other embodiments the articulation range of motion is a lateral panning motion relative to the pointed tip. In some embodiments, the articulation range of motion includes both tilt and panning of the illumination zone. In some embodiments, the articulation mechanism is coupled to the light enclosure34.

Other aspects of the disclosure are shown inFIG.5, where illumination module60incorporates a split module enclosure62, with respective front64and rear66enclosure portions. As shown in the exploded view ofFIG.5, the light enclosure34incorporates a single lens or a stack of multiple lenses68for focusing the beam of the illumination source in the illumination zone (see, e.g., illumination zone21Z ofFIG.2). In other embodiments the illumination module has no lens or lens stack for focusing the beam of the illumination source. In other embodiments, the lens or lenses68and the illumination source are not retained within the light enclosure34and are retained in a fixed position within the module enclosure62.

A light enclosure tilt mechanism70, shown schematically, tilts the light enclosure34in the range of motion T, about pivot axis71, and is coupled to pivot mounts72. The pivot mounts72are shown schematically as affixed to the module enclosure62. The lever knob74, which can be externally accessible, is manipulated by a clinician to move the illumination zone relative to the needle tip26. A sole clinician moves the lever knob74with the same hand that holds the syringe12, freeing the other hand to perform other functions, such as stabilize the potential venipuncture site of a patient. The articulation range of motion is shown as a tilt motion T relative to the needle tip26, but in other embodiments the articulation range of motion is a lateral panning motion relative to the pointed tip. In some embodiments, the articulation range of motion includes both tilt and panning of the illumination zone. In some embodiments, the illumination module has no light enclosure tilt mechanism or external actuation knob.

Referring toFIG.5, the illumination module60retains a printed circuit board76within the module enclosure62for operable electrical circuit interaction of a battery78serving as a power source, and an on/off switch79that selectively couples electric power to an illumination source80. In some embodiments the battery78is a disposable battery, such as the button-type battery shown inFIG.5. In other embodiments, the battery is a rechargeable battery. The illumination source80generates the electromagnetic beam that forms the illumination zone. The illumination source80comprises a light emitting diode (LED) emitter, which emits electromagnetic radiation, focused by the lens or lenses68, and projected through the light enclosure34. More particularly, the illumination source80is an LED-IR emitter, which emits electromagnetic radiation in the infra-red wavelength spectrum. In some embodiments, illumination source80projects an electromagnetic beam in the infra-red spectrum with a wavelength in a range from 696 nm to 1000 nm. In other embodiments, the illumination source80projects an electromagnetic beam wavelength between 740 nm and 940 nm. Various embodiments of the vein illumination modules28and40employ variations of the components of the illumination module60.

Referring now toFIG.6, another aspect of the disclosure provides for a rechargeable battery in the vein illumination module40for powering the illumination source and a corresponding charging or docking station82, with the latter powered by a plug-in electrical cord84. The charging station82provides powered to the rechargeable battery of the vein illumination module40by direct electrical connection (e.g., USB, mini-USB, micro-USB, connector jack, etc.) or by induction charging transformer. In this manner, the vein illumination module40resides in the charging station82when not in use. A phlebotomist or other medical clinician retrieves the reusable illumination module and selectively attaches it to a syringe56when the need arises to use the vein-finding syringe system for patients with difficult veins. In illumination module embodiments that incorporate a general-use clamp, such as the clamp30, the phlebotomist can selectively affix the vein illumination module28to any type of know syringe by clamping it about the syringe barrel.

An exemplary method of use of the vein finding syringe system10and the other embodiments described in this disclosure is shown in the flow chart90ofFIG.7. For brevity, the method is described using the vein finding syringe system10ofFIG.2, wherein a clinician draws blood from or administer a drug intravenously to a patient. At operation92of the flow chart90, the clinician prepares the syringe12by removing it from its packaging. If a vein illumination module28is not already affixed to or integrated within the packaged string, it is attached to the syringe barrel14by way of the clamp30or any other provided syringe/illumination module coupling device. At operation94of the flow chart90, the clinician activates the vein illumination module28with an on/off switch, such as the on/off switch79, thereby activating the illumination source80, e.g., the LED-IR emitter. When the illumination source is activated, it projects a beam into an illumination zone21Z distal the needle's needle tip26. Advantageously, the clinician can reorient location of the illumination zone21Z relative to the needle tip26by manipulating the articulation knob36. This facilitates use of the vein illumination module28as a common module for multiple types of dimensions and geometries of syringes12. In this manner the clinician has the capability of articulating the illumination zone21Z in a desired location distal the needle tip26, no matter what type of syringe is utilized for a specific medical procedure.

At operation96of the flow chart90, the clinician selectively orients the illumination zone21Z on a patient's body P by moving the syringe and identifies a subcutaneous vein19V location that is within the illumination zone. The IR wavelength light emitted by the illumination source80in the form of an LED-IR emitter on the patient within the illumination zone allows the clinician to view a subcutaneous vein with greater contrast than afforded by ambient light. At any time during the procedure, the clinician can articulate location of the illumination zone21Z, by manipulating the articulation knob36. Once a suitable subcutaneous vein19V is identified with the vein illumination module28, the clinician punctures the vein with the needle24of the attached syringe12, while the identified vein remains within the illumination zone21Z, as shown at operation98of the flow chart90.

Upon successful venipuncture, the clinician draws blood from or administers a drug to the patient15P by manipulating the syringe plunger20. Clinician manipulation of the vein finding syringe system10—from initial illumination of the patient with the vein illumination module28, identification of a suitable vein19V, orientation of the syringe to puncture the vein, and translation of the syringe plunger20—are all accomplished with one hand. The clinician's other hand is free to stabilize the patient's venipuncture site or any other task attendant with the medical procedure. A sole clinician can complete successful vein identification and venipuncture of so-called “difficult” veins with the vein finding syringe system10, without assistance of another clinician. Thus, the vein finding syringe system10and the other related embodiments disclosed herein facilitate successful, more comfortable venipuncture for all types of patient veins, by a sole clinician, in less time than required for performing multiple, unsuccessful venipuncture attempts.

Although the disclosure herein provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope thereof. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.