Laser powered capillary blood collecting device system and method

Abstract

A laser-powered capillary blood collecting system includes a sleeve aligned with a hollow blood collection vial having a front operational aperture, a sliding door for selectively opening the aperture, a rear main air valve responsive to negative pressure, and an auxiliary valve configured to release laser-generated plume for a defined time interval. A laser generator module comprises a laser source arranged to emit pulses through the sleeve and vial aperture and a low-pressure source coupled to the vial. The low-pressure source generates a vacuum that opens the main valve, produces suction to draw blood into the vial, and simultaneously creates air flow through the generator module for cooling the laser source. A control unit synchronizes laser emission, sliding door actuation, timed auxiliary valve operation, and closure of the main valve. The system combines optical stimulation, vacuum-assisted collection, and thermal management in a compact integrated structure.

Description

F2358 PCTTITLE OF THE INVENTIONLaser Powered Capillary Blood Collecting Device System and MethodField of the Invention

[0001] The invention relates generally to medical devices and methods for blood collection. More particularly, it concerns systems and apparatus for perforating skin using a laser source and for collecting blood samples, wherein negative pressure is utilized both for cooling of the laser element and for transporting blood into a collection container.Background of the Invention

[0002] Devices are known in the art for perfora^ng the skin of a pa^ent using a laser beam and for collec^ng blood samples in associated containers. Certain prior art references also describe arrangements for focusing a laser beam on a pa^ent’s skin in order to achieve perfora^on. While such systems provide useful func^onality, they typically rely on separate mechanisms for cooling the laser element and for transpor^ng blood into a collec^on container.1

[0003] The prior art further does not disclose systems in which a single source of negative pressure is employed both to cool a laser element and to facilitate transport of blood into a collection container. Nor do existing references describe the use of negative pressure as a basis for automating an entire blood collection process within a secure and sterile environment. Moreover, the integration of a negative pressure source within a laser module itself, which would allow for improved portability and compact device design, does not appear to be addressed in known systems.

[0004] Accordingly, there remains a need for blood collection systems that can automate the complete process—from skin perforation to blood collection—while maintaining sterility and portability.Summary of the Invention

[0005] The invention provides a blood collection system that integrates laser-based skin perforation with negative pressure-driven cooling and suction in a compact and portable arrangement. In contrast to prior systems that require separate mechanisms for cooling the laser and for transporting blood, the disclosed system employs a single source of negative pressure to perform both functions.

[0006] In certain embodiments, a laser module is configured to generate a focused laser beam for controlled skin perforation. The same module incorporates a negative pressure source that not only provides cooling to the laser element, but also2establishes suction for drawing blood into a collection container. By combining these functions, the system eliminates the need for separate cooling of the laser element and blood suction devices, thereby reducing complexity and size.

[0007] The system further supports automation of the entire blood collection process, from skin perforation through blood transfer, within a secure and sterile environment. The integration of the negative pressure source within the laser module facilitates portability, making the device suitable for clinical, field, and home-use applications.

[0008] Accordingly, the invention addresses the limitations of prior art by providing automated, sterile, and portable blood collection solutions that unify perforation, cooling, and suction functions in a single system.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The subject matter regarded as the invention is particularly pointed out and distinctly disclosed in the specification. The invention, however, both as to the device, system and method may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0010] FIG. 1 is a general diagram of the laser powered capillary blood collecting device and system of the invention.3

[0011] FIG. 1A is an enlarged view diagram illustrating an interface between a finger sleeve and a blood collection vial.

[0012] FIG. 1B is an enlarged view diagram illustrating an interface between the blood collection vial and a laser module.

[0013] FIG. 1C is an enlarged view diagram illustrating a process of skin perforation by a laser beam.

[0014] FIG.2 is a diagram illustrating a docking assembly.

[0015] FIG.3 is another diagram illustrating operation of the docking assembly.DETAILED DESCRIPTION OF THE INVENTION

[0016] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.

[0017] The blood collection device of the invention is configured to facilitate accurate, minimally invasive sampling of blood from a fingertip using laser-based perforation. Turning now to FIGS.1, 1A, 1B, 1C, 2 and 3 disclosing a laser powered capillary blood collecting device and system of the invention 10 adapted to open access to4capilary blood by making a skin perforation. This occurs by vaporization of a small amount of skin by a laser beam imitating a skin cut by a steel lancet device typically used for finger skin perforation to get a capillary blood sapmple using a finger stick procedure and stimulate blood flow from the area of perforation. Among essential components of the device and system of the invention are a finger sleeve 12; a blood collection vial 20; a laser generating module 40 and a control unit 70.

[0018] A finger sleeve 12 is formed having a closed end region 14 and an open-end finger insertion region 16. A port 18 is provided within a resilient wall of the finger sleeve near the closed end region 14 to provide access to the skin and to match the operational aperture 26 in the vial. The sleeve 12 is made of an elastic biocompatible material to assure close contact with the finger skin and to prevent air passage therebetween.

[0019] The laser beam of a proper physical characteristics like wavelength, laser pulse duration and the laser pulse energy when focused on an optimul depth at the skin can vaporize a optimally predetermined amount of skin resulted in cutting blood capillaries located there thus opening access to capppilary blood. This is shown on Fig. 1C where laser source 50 emits a laser beam B-B that is focused by a focusing arrangement 51 on a optimally chosen area 21 in the skin. Laser beam vaporizes skin tissue in the vicinity of the area 21 with such vaporized skin material 57 released into the internal area of port 18.5

[0020] As best illustrated in FIGS.2 and 3 in one embodiment, there is provided a docking assembly 9 with male 5 and female 7 components, wherein the male component is associated within the resilient finger sleeve 12, and the female component is integrated into the proximal / front end 22 of a blood-receiving vial 20. Port 18 is configured both to allow visualization of the skin surface and to serve as the docking interface for the blood collection vial 20. The port 18 houses or is adjacent to the male component 5 formed with an optional optical lens or window 11. The female component 7 of the vial 20 includes sliding door / gate 28 that is closed in that starting position protecting sterility inside the vial 20 and this sliding door 28 is opened when the vial 20 is connected to the finger sleeve 12 through the port arrangement 18.

[0021] The male component 5 (see FIG.3) comprises a transparent cylindrical or other shape (matching shape of female part 7) structure 15 incorporating the lens 11 which can be configured as sliding / tiltable transparent element positioned within or aligned with the port 18. In the preparatory mode the lens 11 enables the operator to visually observe the skin surface of the patient’s finger 21 inserted in the sleeve 12, allowing for the identification and selection of an optimal perforation site. This visualization step ensures accurate targeting prior to blood collection. To facilitate laser beam perforation of the skin lens 11 is automatically removed thus opening access for blood to flow into the collection vial. In another embodiment of the6invention there is no lens 11 and there is an open access into male component 5 of the finger sleeve 12.

[0022] The female component 7 of the docking assembly 9 is located at the proximal / front end 22 of the blood collection vial 20 and is configured to receive the male component 5, thereby aligning the sleeve 12 with the vial in an operational position. It will be discussed later in the application in greater detail that a laser module 40 is adapted for engagement with the distal / rear end 24 of the blood collection vial, oriented such that, in the operational condition, a laser beam may be directed through the interior of the vial and the now-open sliding door / gate 28 associated with the port 18 to perforate the skin.

[0023] Upon docking the vial 20 with the sleeve 12, an actuating mechanism 19 displaces or retracts the optical lens 11 to an exterior position 11’ (see FIG.3) from its orientation with the port 18, thereby exposing the predetermined skin site 21 to the laser beam passage. In another embodiment the displacement can be accomplished manually by an operator so that sliding door 28 is opened when the vial 20 is connected to the finger sleeve 12 throught the port arrangement 18.

[0024] One of the essential aspects of the invention is that this configuration eliminates the need for mechanical lancets and enables controlled, sterile, and visually guided perforation using laser technology. Following perforation, the blood7is collected directly into the vial 20, which is positioned in alignment with the puncture site. This configuration enables optical guidance, sterile access, and efficient blood collection without the need for mechanical lancets. The integration of the optical guidance system, actuated lens mechanism 19, and laser-based perforation unit allows for an automated, compact, hygienic, and user-friendly blood collection device. Elimination of lancet and use of laser light for perforation allows for high degree of automation of capillary blood collection, eliminates medical waste of steel lancets, eliminates risk of invection of healthcare wokers through an accidental contaminated lancetstick, as well as cross contamination between patient through re-use of contaminated steel lancets.

[0025] The substantially hollow blood collection vial 20 extends between the front 22 and rear 24 ends. The operational aperture 26 with an associated sliding door / gate 28 are arranged at the front-end 22. The purpose of the sliding door / gate 28 is to protect sterility of the internal area of vial 20 until it is connected with the finger sleeve 12 throught the port arrangement 18. Air valves 30, 30’ and a blood level sensor 32 are positioned in a spaced apart relationship at the rear end 24. The valves 30, 30’ are arranged within an interior of the vail 20 to facilitate air movement from the front area of the vial 22 towards its rear end by the negative pressure force created by a low-pressure source 52. This is accompanied by removal of the plume 578developed as a result of interaction of the laser beam and a finger skin of a patient and directing the plume to the disposable filter 36.

[0026] As will be discussed in greater detail below, the valves 30, 30’ are configured to open for a predetermined period coordinated with the emission of a laser pulse and signals from sensors 32 and / or 38. This opening period allows for the creation of negative pressure force between the the front end 22 and rear end 24 of the blood collection vial as well as an evacuation of smoke or plume generated within the blood collection vial into a filter 36 positioned between the vial 20 and the laser generator module 40. The duration of the valve's open state may be optimally determined based on system parameters, and the valves are designed to close automatically thereafter. In some embodiments, the operation of the valves 30, 30’ may be further controlled or adjusted in response to a chemical reaction.

[0027] To facilitate visual evaluation of the collected blood sample, at least a portion of a side wall of the blood collection vial 20 may be formed from a transparent material. The interior surface of the side wall may be at least partially coated with a material configured to indicate the presence of specific analytes, such as glucose, HbA1c, Triglyceride, coumadin, cholesterol, etc., during rapid blood analysis. To improve handling by an operator, the exterior surface of the side wall may be at least partially covered with non-slip material. Additionally, to neutralize odors and protect internal components of the perforation device from contamination due to skin- 9emitted substances, the interior surface of the blood collection module or vial may be coated with a layer of absorbent material. In some embodiments, the absorbent material may comprise activated carbon.

[0028] The laser generator module 40 includes an elongated casing 42 having a substantially hollow interior extending between a proximal end 44 and a distal end 46. A laser source or generator 50 may be positioned at the central area or proximal area of the casing 42. The laser source 50 may comprise any suitable type of laser that is capable of vaporizing a cut in the skin to allow an access to capillary blood vessels, irrespective of the energy source employed to power the laser, including, but not limited to, a solid-state laser, a semiconductor diode laser, or a fiber laser. Lasers that have high absorbtion in water are suitable for skin perforation with a laser wavelength close to 2940 nm represent a preferred choice because of the highest absorbtion of this wavelength in water.

[0029] In the illustrated embodiment the low-pressure source 52 provided to generate a lower pressure zone or vacuum 54 is arranged within the substantially hollow internal area of the casing. On the other hand, the low-pressure source can be any conventional means / arrangement such as an air pump, etc., which can be positioned inside or outside of casing 42. The low-pressure zone 54 results in the pressure differential between the proximal end 44 and a distal end 46 of the casing,10so that a longitudinal flow of air or gaseous coolant is generated passing along the laser generator 50.

[0030] One or more air intake valves 27, 27′ are positioned at the interface between the front end 22 of the blood collection vial 20 and the docking assembly 9. These air intake valves serve an essential function in regulating airflow within the apparatus 10. In a default state, the valves 27, 27′ remain closed. They are calibrated to selectively open only when the low-pressure source 52 is activated to establish a reduced pressure zone or vacuum 54 within the apparatus that translates through the open valves 30, 30’ into creation a negative pressure at the rear end section 24 of the vial. Upon activation of the low-pressure source 52, the resulting differential pressure causes the valves 27, 27′ to open, thereby permitting atmospheric air to enter into the interior of the vial and through the entire apparatus 10. Once the reduced pressure condition ceases, the valves 27, 27′ automatically return to a closed configuration, thereby preventing unintended air ingress.

[0031] During operation, when the blood collection procedure is initiated, the front end 22 of the vial 20 is positioned at the port 18 engaging a predetermined skin area of the patient for perforation. Activation of the low-pressure source 52 produces the vacuum 54 and consequently triggers the opening of the valves 27, 27′. The resultant air stream (A–A) is directed through the interior of the vial 20, generating a suction flow that draws blood from the perforated skin site into the vial for accumulation.11Thus, the air intake valves 27, 27′ provide controlled and automatic regulation of air ingress, ensuring proper establishment of suction flow during blood collection, while also preventing leakage or backflow when the low-pressure source is inactive.

[0032] The air stream A-A enters the interior of casing 42 through an inlet opening of the air valves 30, 30’ provided at the rear end 24 of the vial and through air cleaning filter 36 that removes smoke and skin debtis produced during laser skin perforation and is discharged through exit openings 58 provided at the distal end 46 of the casing. As a result of the lower pressure zone or vacuum 54, the gaseous or air stream A-A directed along the laser generator 50 is adapted to remove or dissipate heat therefrom.

[0033] A vacuum is generated by the low-pressure source or air pump 52, which creates a negative pressure zone 54 by drawing air from the interior of the blood collection vial 20 through the air valves 30, 30’, which remain open under the influence of the negative pressure produced by the air pump 52. A vacuum sensor 48 is configured to activate a mechanism that opens a sliding door 28. Alternatively, a sliding door 28 can be opened by a mechanical movement associated with the connection of the vial 20 with a finger sleeve 12. Upon opening the operational aperture 26, a laser beam B-B can pass through the port 18 in the sleeve 12, thereby reaching a predetermined area 21 of the user’s skin selected for blood extraction. An essential feature of the invention is that the vacuum generated negative pressure zone1254 also extends to the interior of blood collection vial 20 assists in drawing blood from the patient’s finger 21 into the vial interior.

[0034] When operation of the low-pressure source (e.g., the air suction pump 52) ceases, operation of the air valves 30, 30’ is automatically terminated by an actuated mechanism. This mechanism is configured to open the valves in response to the presence of a vacuum and to close the valves automatically when the vacuum force is no longer present.

[0035] It should be noted that a further essential function of the low-pressure source 52, and the resulting negative pressure zone 54, is not only to provide cooling for the laser module 40, but also to generate a suction force utilized to draw blood from the patient's skin and deliver it into the blood collection vial 20.

[0036] At a predetermined point (when there is enough blood accumulated in the vail 20) and the blood reaches the blood level sensor 32, a signal is generated by the control unit 70 to stop vacuum suction, simultaneously the sliding door 28 and the operational aperture 26 are closed sealing the blood sample within the vial.

[0037] As shown in at least FIG.1, an adjustable diaphragm 23 having an opening 25 is positioned in the interior of the vial 20 between to the blood level sensor 32 and the rea end wall 24. During operation, the opening 25 remains open to permit passage of the air stream and a laser beam within the vial. Once perforation has been13completed and a sufficient quantity of blood has accumulated, the opening 25 is closed. Thus, the diaphragm 23 serves to confine the collected blood within the section of the vial 20 located to the left of the diaphragm 23, thereby preventing unwanted migration of blood into the filter 36 associated with the laser module 40.

[0038] In one embodiment, the interface between the blood receiving vial 20 and the casing 42 is defined by the rear end wall 24 of the vial 20 and the proximal end wall 45 of the housing 42. These walls form an aligned barrier across which the laser beam passes during operation of the device. To facilitate reliable penetration of the laser beam through the device, both the rear end wall 24 and the proximal end wall 45 are fabricated from materials that are substantially transparent to the laser wavelength selected for tissue perforation. Transparency at the operating wavelength is critical in order to avoid absorption, scattering, or reflection losses that would otherwise reduce the effectiveness of the laser energy delivered to the skin. The thickness of each wall 24, 45 may be configured to provide a balance between optical performance and structural integrity. For example, the thickness may be reduced to minimize optical absorption and refraction effects, while maintaining sufficient strength to withstand internal negative pressure or external handling forces.

[0039] A temperature sensor 62 can be provided to prevent the laser skin perforator device operation when the temperature of the laser generator 50 is higher than the predetermined maximum limit. In this situation the temperature sensor 62 generates14a signal directed to the control unit 70 to energize the low pressure or vacuum source 52 to pump air stream to cool the laser generator 50 to an optimum temperature.

[0040] As an optional feature, a color indicator may be provided along the path of the blood flow to the blood level sensor 32. The color indicator is configured to detect and indicate a specific measurement parameter of the blood. An electronic sensor may then capture this data and transmit it for further analysis and storage.

[0041] In use of apparatus 10, the gaseous or air stream A-A, which may function as a coolant, can contain particulate matter resulting from the interaction of the laser beam with the patient’s skin. This particulate matter, which may include biological debris, is considered a potential biohazard and must be removed from the airflow for proper containment and disposal. To facilitate this, a disposable filter 36 is positioned at the proximal end 44 of the casing 42, at the interface with the blood collection vial 20 and adjacent to the air valves 30, 30’ and auxiliary discharge valves 34, 34’. The valves 30, 30’ regulate the flow of air from the blood collection vial into the laser module 40. Filter 36 is configured to capture the aerosolized plume generated by laser ablation of the skin, which occurs when a small incision is made to access a blood capillary. After use, the filter 36, containing the captured biological material, is discarded in accordance with appropriate biohazard disposal procedures.15

[0042] According to the method of the invention the finger sleeve 12 of the proper size is placed on the finger, so that the port 18 corresponds to or is disposed at an area of the finger skin 21 chosen for the perforation and ultimately for blood collection. According to one embodiment of the invention the front end 22 of the blood collecting vial is connected to the docking station 9 associated with the finger sleeve 12, whereas the rear end 24 is connected to the proximal end 44 of the laser module 40.

[0043] In operation, upon opening, the sliding door 28 provides access to the skin perforation area. Initially, the low-pressure source 52 produces a vacuum or negative pressure within the casing 42 and the interior of the blood collection module or vial 20. This negative pressure is communicated to the port 18 of the finger sleeve 12. The flexible or resilient wall of the sleeve 12 conforms closely to the patient’s skin such as a finger or other body part forming an airtight seal. Sleeve 12 can be adapted to be attached to different parts of the body other than finger skin, if such parts are chosen for blood sampling. As air is evacuated from the interface between the target skin surface and the port 18, the contact between the blood collection vial’s docking arrangement 9 and the skin is further secured. When the laser skin perforator is actuated to create an incision, the vacuum generated by the negative pressure source 52 assists in drawing blood from the patient’s capillaries into the blood collection module or vial 20. Once the blood reaches a predetermined level within the blood16collection vial, as detected by the level sensor 32, a signal is generated to deactivate the vacuum source, thereby terminating suction.

[0044] Once a predetermined volume of blood has been collected, the sliding door 28 closes to seal the operational opening 26 of the blood collection vial. This sealing action may be triggered automatically in response to a signal from the blood level sensor 32 or may be performed manually by rotating the blood collection vial relative to the finger sleeve, which in turn actuates the docking mechanism 9 to seal the blood collection module or vial. The blood collection vial may be configured to include integrated testing functionality or may serve solely as a collection vial. In the latter case, the collected blood sample is intended to be transferred to an external facility for diagnostic analysis.

[0045] A control unit 70 is provided to regulate the laser energy produced by the source / laser generator 50 for the optimum output level and different characteristics of the laser light (such as wavelength, pulse duration, pulse shape, repetition rate etc.) based on type and characteristics of the targeted skin (hard, soft, etc.) and amount of blood sample needed which may be regulated by the depth of the laser cut in the skin. Characteristics of the control unit 70 may be adjusted either automatically or by an operator. Such characteristics can be manually or automatically adjusted based on the signals and data received from the sensors such17as the blood level sensor 32, vacuum sensor 48, temperature sensor 62 etc. provided in the device.

[0046] The control unit 70 houses a programmable logic controller or microchip 72 to control the system and apparatus of the invention. The control unit 70 also preferably incorporates control systems for actuating, adjusting and providing system information concerning laser power and other characteristics, which displays reading of the sensors. The control unit 70 may include, but not limited to laser power control unit, vacuum control unit, etc. By means of a computer or microchip 72 the control unit 70 utilizes inputs received from multiple sensors, such as the blood level sensor, vacuum sensor, temperature sensor etc. to continuously update output to an operator including such operating parameters as laser parameters delivered to the skin site, temperature at the skin, and the like.

[0047] The control unit 70 is adapted to regulate the laser power source / generator 50 for the optimum output level based on type and characteristics of the targeted skin site (hard, soft, etc.). Characteristics of the control unit 70 may be adjusted by the operator or automatically based on inputs from the sensors. Controlling various characteristics / parameters at the skin perforation site is based on the information provided by sensors (such as the blood level sensor, vacuum sensor, temperature sensor at ctr.).18

[0048] A control unit 70 is operatively coupled to the laser source or generator 50. The control unit 70 regulates the operating characteristics of the laser output, including energy level, wavelength, pulse duration, pulse shape, and repetition rate. In particular, the control unit 70 is configured to adapt these laser parameters in accordance with the type and characteristics of the targeted skin, such as hardness, softness, thickness, or hydration level. By dynamically matching the laser output profile to the patient’s skin condition, the device ensures efficient perforation with reduced thermal and mechanical trauma.

[0049] The laser beam emitted from the laser source 50 is directed toward a focusing arrangement 51 associated with the casing. The focusing arrangement 51 comprises one or more optical elements 53 configured to converge the laser beam at a selected focal point in the skin of the patient adapted for blood collection penetration. The focusing arrangement 51 can be self-adjusting, meaning that it automatically modifies the focal depth based on patient-specific skin thickness and anatomical variations. Adjustment may be achieved through optical feedback sensors, mechanical depth-sensing elements, or closed-loop electronic control systems coordinated by the control unit 70. During operation, the focusing arrangement 51 positions the laser beam focal point such that the beam penetrates the skin at an optimal depth to reach the capillary blood vessels. The controlled penetration depth is critical for obtaining consistent blood samples while minimizing patient pain. By19synchronizing the output characteristics of the laser generator 50 with the focusing arrangement 51, the device 10 provides precise and reproducible capillary access.

[0050] Blood released through the perforation is collected by the blood receiving vial 20 or other suitable receptacles integrated into or used in conjunction with the device 10 of the invention. The regulated depth and laser characteristics ensure that the blood volume collected is sufficient for diagnostic testing but does not exceed what is necessary, thereby improving safety and patient comfort.

[0051] As previously discussed, the negative pressure / vacuum source or air pump 52 is capable of creating the thrust accommodating various suction levels. In this manner, the level of suction is controlled by the control unit 70 depending on the following characteristics:Level of Suction 1 depends on the temperature of the laser emitter.Level of Suction 2, which follows an algorithm of device operation steps / functions, depends on / reflects the skin perforation and removal of generated smoke / skin debris. Level of Suction 3 should create sufficient negative pressure to draw off a specified amount of blood into the test blood collection module or vial.Level of Suction 4 is provided for a self-cleaning function of the device.20

[0052] Sensors 32, 48, 62 etc. may emit and receive various types of signals (optical, electromagnetic, acoustic, capacitance measuring) that will change parameters depending on the composition of the skin cite, etc., so as to allow the control unit 70 to calculate and generate proper signals controlling operation of the laser source / generator 50.

[0053] Sensors 32, 48, 62 etc. are able to recognize / determine among other data the physical and chemical composition of the patient’s skin and or the collected blood. The computer or microchip 72 associated with the control unit 70 receives and analyzes information / data obtained by the sensors and generates signals to adjust parameters of the power source, the produced vacuum etc. to optimize the blood taking process.

[0054] According to one embodiment of the invention, sensors 32, 48, 62 etc. are capable of detecting the level of the skin hardiness, water / moisture content, etc., within the patient’s body. As the laser beam is applied to various skin area conditions, optimal levels of laser radiation can be achieved for each skin area. For example, a lower level of radiation and / or higher repetition rate can be provided for the skin having higher degree of hardiness / roughness. On the other hand, lower levels of radiation and / or lower repetition rate will be generated and directed to the areas with softer skin characteristics. Laser power source 50 may also be able to generate different wavelength or pulse duration irradiation optimized for the most21optimal effect on the targeted skin area. The generated beam controllably penetrates through the skin as being absorbed in the target area at the predetermined depths for example.

[0055] Different wavelength or pulse duration irradiation can be optimized either 1) for optimum cut / vaporization of skin tissue for which 2940nm wavelength with 100-400 microsecond pulse duration can optimum or2) for stopping / coagulating of blood flow from the laser made cut in the skin after sufficien amount of blood sample is collected the laser wavelengths that are well absorbed in blood can be chosen including but not limited to laser wavelengths in the yellow-green to near infra-red range (for example 532nm, 585 nm, 595 nm, 810nm, 940nm, 980 nm or 1064nm, others) and 1 to 100 millisecond pulse duration range. Such laser wavelengths will also provide for closing and sterilization of laser cut in the skin.

[0056] Sensors 32, 48, 62 etc. are able to recognize / determine the physical and chemical properties of the skin and / or the collected blood. A computer or microchip 72 associated with the control unit 70 receives and analyzes information / data obtained by the sensors 32, 48, 62 etc. and generates signals to adjust parameters of the laser power source 52 and other to optimize skin penetration and / or to produce other desired effect on targeted tissue. As an example, control unit 70 analyzes22information / data obtained by the sensors 32, 48, 62 etc. and generates signals to adjust parameters of the laser power source 52 to optimize operation of the device.

[0057] The sensors 32, 48, 62 etc. are capable of detecting the level of hardiness, water / moisture content, etc., within the skin material. As the device of the invention is applied for taking blood samples from multiplicity of patients, the optimal level of irradiation, and other characteristics can be adjusted to accommodate the requirements of each specific patient.

[0058] Utilization of a laser in the device and system of the invention may be accompanied by automatic target feedback, thermal feedback for example, to precisely control the dosimetry of the laser irradiation. This is needed to prevent damage to surrounding tissue. An output of an optional non-contact thermal detector 17 can be used to adjust the output of the laser source 50 to maintain selected characteristics including temperature at the skin perforation site.

[0059] Absorption of laser energy by the skin material may result in elevation in temperature of the surrounding tissue. In the invention, this occurs controllably without causing irreversible thermal damage to the surrounding tissue. The laser unit 50 adjusts the energy to maintain a pre-selected target temperature at the skin perforation site.23

[0060] Upon activation of the negative pressure generating arrangement or an air pump 52, the vacuum sensor 48 triggers the mechanism causing opening of the sliding door 28. As the laser generator 50 generates the laser pulse which passes through the vial interior and the operational aperture 26 to access the skin. As a result, a small cut at the finger skin is vaporized.

[0061] The blood flow into the blood collecting vile 20 is assisted by the vacuum force generated by the low-pressure source 52 of the laser generating arrangement 50. When suction is applied to the skin area chosen for perforation it pulls the skin outward, creating a small bulge. This bulging effect helps to engorge the capillaries and veins in the area to increase the local blood flow to the puncture site. This can make it easier to collect a blood sample as more blood is drawn into the collection area. This approach makes blood collecting less invasive and more comfortable and is especially beneficial for routine tests like glucose monitoring for diabetes, where frequent and small blood samples are needed.

[0062] As the collected blood reaches the blood level sensor 32, the low-pressure generating arrangement or the air pump 52 stops, initiating closure of the sliding door 28 and causing sealing of the vile with the collected blood sample.24

[0063] As to the next step of the method of the invention, the vial 20 is detached from the finger sleeve 12, and the blood sample collected in the vile is being sent to be analyzed by an outside provider. Alternatively, an autonomous blood testing arrangement 38 can be provided within the vile.

[0064] When the blood sample is analyzed the data is sent to the processor 72 for processing the test results, which can be displayed on the screen 64 or recorded in the processor. On the other hand, it can be transmitted by the blue tooth 64 or by any other suitable technology to be sent to a medical provider. An optional arrangement can be provided to issue an alert if results are not within the norm.

[0065] In operation of the method and apparatus of the invention the Bluetooth technology can be used to transmit the results of blood tests from a device to an external provider by following a general process:Data Collection•The device of the invention collects blood test data, whereas the vile or the entire device equipped with Bluetooth technology.Data Transmission via Bluetooth• The collected blood test data is transmitted wirelessly via Bluetooth to a paired device, typically a smartphone, tablet, or computer. This transmission is secure and can be encrypted to protect patient data.25Application Processing•The paired device runs a specific application or software designed to receive the blood test data via Bluetooth. The application may format, store, and display the data for review.Data Encryption and Transmission to an External Provider• The application on the paired device may further process the data and encrypt it before sending it over the internet to an external provider for analysis. This can be done using secure channels such as HTTPS or through a secure healthcare information system.Provider Analysis• The external provider receives the transmitted data, decrypts it, and then processes it using their systems. They may perform additional analysis, cross-reference it with other data, or use it to make a diagnosis.Feedback Loop• The external provider might send feedback, further instructions, or additional insights back to the patient or the healthcare provider using similar secure channels.26Example Use Cases•Glucose Monitoring: Continuous glucose monitors (CGMs) often use Bluetooth to send blood sugar readings to a mobile app, which can then send this data to a healthcare provider.• Point-of-Care Testing (POCT): Portable blood analyzers used in clinics may transmit results via Bluetooth to a central system or directly to a lab for further analysis.

[0066] In the system of the invention Bluetooth-based technology allows for quick and efficient data transfer, enabling timely analysis and response by healthcare professionals.

[0067] The device and system of the invention can be operated by the batteries 68 or can work from outside electrical supply.

[0068] The technology of the invention provides an efficient and convenient way of making the blood draw simple, practically mistake free and automated. The invention allows to automatically through the use of vacuuming force to collect blood samples without contamination. The device is portable and allows fully automated capillary blood drawing ultimately eliminating safety risks.27

[0069] An essential aspect of the invention is that the negative pressure source or air pump provided to cool the laser generator also operates as the negative pressure or the suction arrangement for suction of the blood from a skin of a patient into the blood receiving vile.

[0070] The apparatus of the present invention is configured to capture and remove the aerosolized plume generated during the interaction of laser energy with the skin, wherein a small incision is created by laser ablation. The incorporation of the disposable filter 36 enables effective filtration and containment of the plume, which may include viral particles or other potentially hazardous biological or chemical contaminants.

[0071] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0072] While implementations of laser-stimulated capillary blood collection device / system of the above-discussed invention have predominantly targeted the fingertip due to its rich capillary bed and accessibility, the physiological principles underlying localized photothermal perforation are not unique to the finger. Various28other anatomical sites, including but not limited to the toe, heel and forearm, possess sufficient microvascular density to enable similar enhancement of capillary blood flow in response to laser-based application / stimulation.

[0073] Accordingly, in certain embodiments, the system of the invention may include a perforation and collection assembly adapted for application to alternative anatomical regions beyond the finger. For example, the device of the invention may be configured to include instead of the finger sleeve a patch for forearm application, a toe sleeve or an earlobe clip, wherein the laser perforation or laser source is calibrated to deliver a localized stimulus sufficient to induce increased capillary perfusion. The corresponding blood collection modules such as a vacuum-assisted tube, or capillary absorption element—may be adapted in form factor and depth of penetration based on the skin thickness and capillary distribution of the targeted body site.

[0074] The feasibility of this multi-site approach is supported by existing clinical practices that utilize the earlobe, heel, and forearm for capillary blood sampling under various circumstances. This invention contemplates the application of laser-augmented capillary stimulation and blood collection methods to a broad range of anatomical sites, enabling flexibility in design, improved patient comfort, and potential integration into wearable or mobile health-monitoring platforms.29

[0075] It has been discussed above that the invention provides a blood collection system that integrates laser-based skin perforation with negative pressure-driven cooling and suction in a compact and portable arrangement. In contrast to prior systems that require separate mechanisms for cooling the laser and for transporting blood, the disclosed system employs a single source of negative pressure to perform both functions.

[0076] In certain embodiments, a laser module is configured to generate a focused laser beam for controlled skin perforation. The same module incorporates a negative pressure source that not only provides cooling to the laser element but also establishes suction for drawing blood into a collection container. By combining these functions, the system eliminates the need for separate cooling and suction devices, thereby reducing complexity and size.

[0077] The system further supports automation of the entire blood collection process, from skin perforation through blood transfer, within a secure and sterile environment. The integration of the negative pressure source within the laser module facilitates portability, making the device suitable for clinical, field, and home-use applications.30

Claims

CLAIMSWhat is claimed is:

1. A laser-powered capillary blood collecting system for stimulating blood flow in a perforated region of a patient’s skin and collecting blood therefrom, the system comprising:(a) a sleeve having a port;(b) a substantially hollow blood collection vial extending between a front end and a rear end, the blood collection vial comprising:• an operational aperture disposed at the front end and aligned with the port in the sleeve,• a sliding door configured to selectively open and close the operational aperture,•a main air valve disposed at the rear end and configured to open under a negative pressure and to close when the negative pressure is released, and (c) a laser generator module comprising an elongated casing having a proximal end and a distal end, the laser generator module including:1• a laser source disposed at the proximal end and configured to emit a laser beam through the opening in the sleeve and the operational aperture of the blood collection vial so as to perforate the skin,•a low-pressure source configured to generate a vacuum within the rear part of laser case and consequently in blood collection vial by drawing air through the main air valve, thereby creating a pressure differential between the front end and the rear end of the blood collection vial, the vacuum simultaneously facilitating suction of blood into the blood collection vial and producing an airflow through the laser generator module for cooling the laser source; and (d) a control unit operably coupled to the laser source, the low-pressure source, the main air valve, and the sliding door,wherein the vacuum generated by the low-pressure source causes an airflow through the laser generator module to dissipate heat from the laser source and simultaneously produces suction to draw blood from the skin of the patient through the operational aperture into the blood collection vial.

2. The system of claim 1, wherein said sleeve is formed of a resilient material having a closed-end region and an open-end region, the closed end region accommodating said opening;2wherein said sleeve is configured for insertion on a finger, said port is configured to provide access to the skin of the finger.

3. The system of claim 1, further comprising:a filter arranged at an interface between the blood collection vial and the laser generator module, wherein the filter is configured to capture debris comprising particles of human flesh generated by interaction of the laser beam with the skin, and wherein the filter filters the debris from an airflow drawn through the main air valve and collects the debris for disposal.

4. The system of claim 1, wherein the vacuum generated by the low-pressure source creates a pressure differential between the front and rear ends of the blood collection vial, thereby inducing a longitudinal airflow through the laser generator module from the main air valve at the proximal end to an exit opening at the distal end, the airflow being configured to dissipate heat from the laser source.

5. The system of claim 1, wherein the control unit is configured to terminate operation of the low-pressure source, to close the sliding door and / or a diaphragm3when the blood level sensor detects that a predetermined volume of blood has been collected in the blood collection vial.

6. The system of claim 1, further comprising a temperature sensor operably coupled to the control unit, wherein the temperature sensor is configured to prevent operation of the laser source when the temperature of the laser source exceeds a predetermined threshold, and wherein the control unit is further configured to activate the low-pressure source to cool the laser source until it returns to a safe operating temperature.

7. The system of claim 3, wherein the filter is configured to capture particulate matter including skin and tissue debris generated during laser-induced perforation of the skin and is removably mounted within the laser generator module for subsequent disposal.

8. The system of claim 1, wherein the sleeve is configured to form an airtight seal with the patient’s skin, and wherein the vacuum generated within the blood collection vial enhances the seal by drawing the sleeve into closer contact with the skin to improve blood extraction efficiency following laser perforation.

49. The system of claim 1, wherein the control unit being configured to:•control emission of laser pulses,•open the sliding door in response to detection of the vacuum within the blood collection module or vial,• close the sliding door in response to detection of the signal from the blood sensor within the blood collection module or vial,•activate the auxiliary valve for a predetermined time after each laser pulse to evacuate plume from the blood collection module or vial, and•close the main air valve upon cessation of the vacuum generated by the low- pressure source.

10. A blood collection device comprising:(a) a resilient finger sleeve configured to receive a fingertip, the sleeve having a closed-end region and an open proximal end;(b) a port located near the closed-end region of the sleeve;(c) a male component positioned within or adjacent to the port, the male component comprising a transparent optical lens or door;5(d) a female component configured to engage with the male component, the female component being located at a proximal end of a blood collection vial; and(e) an actuating mechanism configured to displace the optical lens from the port upon engagement of the male and female components, thereby exposing a skin site to a laser beam;wherein the optical lens enables visualization of the skin surface prior to perforation, and the laser beam creates a perforation at the exposed skin site to enable blood collection.

11. The device of claim 10, wherein the optical lens is movably or pivotably mounted within the male component.

12. The device of claim 10, wherein the actuating mechanism is actuated upon docking of the blood collection vial.

13. The device of claim 10, wherein the optical lens is transparent and aligned with the port to allow visual inspection of the skin without removal of the sleeve.

614. The device of claim 10, wherein further comprises a docking assembly formed by said male and female components.

15. The device of claim 14, wherein the port houses the male component of the docking assembly, which includes the optical lens or window,wherein the female component of the docking assembly is located at the proximal end of the blood collection vial and is configured to receive the male component, thereby aligning the sleeve with the vial in an operational position.

16. The device of claim 10, wherein upon docking the vial with the sleeve, an actuating mechanism displaces the optical lens from the port, thereby exposing the predetermined skin site.

17. The device of claim 10, further comprising a laser unit disposed at a distal end of the blood collection vial and configured to emit a laser beam through the interior of the vial and the port toward a skin site on the fingertip.718.The device of claim 1, further comprising a blood level sensor disposed at the rear end of the vial.

19. A method of creating an automated process for collecting a capillary blood sample using a single source of negative pressure, the method comprising:(a) generating, by said single source of negative pressure, a reduced pressure condition within a rear portion of a laser generator module and within a blood collection vial operatively coupled thereto;(b) automatically perforating skin of a patient by directing a laser beam from a laser source through an operative aperture of the blood collection vial to provide access to capillary blood;(c) establishing, by said negative pressure, a pressure differential between a front end and a rear end of the blood collection vial;(d) automatically drawing capillary blood from the perforated skin region into the blood collection vial in response to said pressure differential; and(e) concurrently producing, by the same negative pressure, an airflow stream through the laser generator module, said airflow stream (i) assisting transport of blood into the blood collection vial and (ii) dissipating heat from the laser source to effect cooling of the laser generator module,8wherein steps (a)–(e) are performed in coordination to effect an automated collection of the capillary blood sample.

20. The method of claim 19, wherein the automated collection of the capillary blood sample is carried out using a laser-powered capillary blood collecting system comprising: a sleeve having a port; a substantially hollow blood collection vial extending between a front end and a rear end and including an operational aperture at the front end aligned with the port, a sliding door configured to selectively open and close the operational aperture, and a main air valve at the rear end configured to open under said negative pressure; and a laser generator module housing the laser source and the single source of negative pressure, the negative pressure simultaneously producing said airflow stream for cooling the laser source and generating suction to draw blood into the blood collection vial.9

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