Practical heel blood collection pen

The heel blood collection pen addresses pain and inefficiencies in current methods by integrating vacuuming and puncturing functions to reduce manual squeezing and enhance blood collection efficiency, thereby alleviating pain and procedural discomfort in newborns.

WO2026039016A1PCT designated stage Publication Date: 2026-02-19SELÇUK ÜNİVERSİTESİREKTÖRLÜĞÜ
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Patent Information

Application Number
PCT/TR2025/050949
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-08-12
Publication Date
2026-02-19

AI Technical Summary

Technical Problem

Current heel blood collection methods cause pain due to manual squeezing during tissue perfusion and require repetitive procedures, leading to increased pain and discomfort in newborns, especially premature infants.

Method used

A heel blood collection pen with integrated vacuuming, puncturing, wiping, and blood collection functions, utilizing a vacuum head, piston, mechanical lancet, and absorbent cotton wool to minimize manual squeezing and reduce the number of punctures.

Benefits of technology

Reduces behavioral and physiological distress by eliminating the need for manual squeezing, saving time, and increasing the blood volume collected efficiently, thus minimizing pain and procedural discomfort.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a heel blood collection pen which sequentially enables vacuuming, puncturing, wiping the first blood, taking the blood into the tube and then impregnating to the Guthrie paper. Thanks to the heel blood collection pen subject to the invention, the squeezing process performed for tissue perfusion in the heel blood collection procedure is terminated, thus completely eliminating the pain that will occur in the newborn with this procedure. With the use of a mechanical lancet at the puncture stage, there is no need to repeat the procedure throughout the entire intervention and the procedure time is minimized. In addition, since the invention is developed in pen format, it is practical and can be easily applied by the nurse. Furthermore, thanks to the increase in the volume of the blood tube in the invention, the nurse does not need to perform repeated procedures during the blood collection and impregnation to the Guthrie paper, thus eliminating the waste of time.
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Description

[0001] PRACTICAL HEEL BLOOD COLLECTION PEN

[0002] TECHNICAL FIELD

[0003] This invention pertains to a heel blood collection pen designed to sequentially perform vacuuming, puncturing, removal of the initial blood drop, collection of blood into a tube, and subsequent absorption onto Guthrie card. The heel blood collection pen subject to the invention comprises four distinct functions: vacuuming, puncturing, removal of the initial blood, and collection of blood into a collection tube.

[0004] BACKGROUND

[0005] According to the definition of the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage [8], The perception of pain begins in the intrauterine 2nd trimester (20th-22nd week of pregnancy); the newborn gives physiological, behavioral and hormonal responses to the pain caused by mechanical, thermal and chemical stimuli exposed following birth

[0022] , The presence of pain mechanisms at such an early developmental stage highlights the necessity of minimizing both the frequency and intensity of pain experiences in neonates, as well as mitigating their potential adverse consequences.

[0006] It has been reported that in Tiirkiye, at least one million infants have been born each year over the past five years

[0020] , Each newborn is administered a Hepatitis B vaccination at birth and undergoes heel -prick blood sampling at least twice within the first few days of life as part of the Newborn Metabolic and Endocrine Disease Screening Program

[0017] , Premature newborns are exposed to this and similar painful intervention, which is inevitable even in healthy newborns, much more frequently [7], According to the World Health Organization report; it is known that approximately 15 million babies are bom preterm every year and prematurity is one of the most important reasons for admission to the Neonatal Intensive Care Unit (NICU)

[0021] , A newborn, whether born at term or prematurely, is exposed to various painful interventions (heel prick, aspiration, intravenous catheterization, etc.) during treatment and care in the NICU. It was reported that a premature newborn underwent painful procedures at least 7 times a day on average in the first 14 days after admission to the NICU [2,7,9,16], Premature newborns are stressed by these painful interventions

[0014] that they are exposed to in the early period, and they are more affected by the negative effects of this stress due to their immature physiologic systems [3], Repeated and untreated pain causes hypersensitivity to pain in premature infants and has negative effects on their motor, intellectual and behavioral development [13,19], Therefore, in unavoidable repeated painful procedures, reducing the duration of the intervention and employing pain-mitigating techniques will significantly alter the neonate’s short- and long-term pain responses and help alleviate the neurodevelopmental consequences of pain.

[0007] In the 2021 Update of the Turkish Neonatal Society Guideline on the Neonatal Pain and Its Management, heel prick blood collection is among the most common painful procedures that newborn babies are exposed to and require precautions

[0022] , In epidemiology studies involving premature infants in the NICU, heel blood collection and aspirations are among the prominent painful interventions [2,7,9,16], Therefore, interventions that reduce pain for these interventions are very important. Evidence-based nonpharmacological methods that reduce pain for this purpose include developmental care practices such as massage, kangaroo care, music, non-nutritive sucking / pacifier giving, wrapping, prone positioning, rocking, breastfeeding / breast milk, touching, cuddling, fetal positioning and reducing environmental stimuli

[0010] , It has been reported that methods such as kangaroo care [5,6] and listening to music

[0011] during heel prick blood collection from preterms decreased the pain score. In addition to these studies to reduce the sensation of pain during heel prick blood collection, there are also studies to make the painful procedure itself painless. It has been reported that behavioral and physiological distress and the number of punctures decreased, blood volume increased, blood sampling time and hemolysis decreased with the use of mechanical lancets compared to manual puncture during heel prick blood collection [4], In this direction, although the use of a mechanical lancet is convenient, it has been reported that the most painful stage in heel blood collection is not the puncture of the heel, but the squeezing of the heel; continuous squeezing without allowing the blood collection area to re-perfuse increases the procedure time and pain

[0022] , In order to prevent this situation and reduce the pain experience of premature infants in the NICU as much as possible, it has become necessary to develop easy-to-use and low-cost tools that will reduce manual squeezing as well as the use of mechanical lancets. So far, no tool has been found to perfuse the blood to the area without the need to squeeze, which is the main source of pain in the heel blood collection attempt.

[0008] In Tiirkiye, heel prick blood is collected from all newborns at least twice in the first few days of life within the scope of the Newborn Metabolic and Endocrine Disease Screening Program for Spinal Muscular Atrophy, Phenylketonuria, Congenital Hypothyroidism, Biotinidase Deficiency, Cystic Fibrosis, Congenital Adrenal Hyperplasia and Spinal Muscular Atrophy

[0017] , The steps of the heel blood collection procedure are important for the accuracy of the test results and the procedure is performed in the following order [1,15]:

[0009] • Necessary materials are prepared (needle tip or mechanical lancet not exceeding 2 mm for term newborns and 1 mm for preterm newborns, alcoholic cotton, sterile gauze, Guthrie paper on which information about the newborn is written)

[0010] • The outer sides of the heel are safe areas for blood collection and the heel should first be warmed for blood perfusion (3-5 minutes) (Warming the baby's foot with the palm of the hand or a warm towel, massaging it and keeping it below the level of the heart will accelerate blood flow)

[0011] • The application area is wiped with 70% isopropyl alcohol cotton wool and allowed to dry.

[0012] • The first drop of blood after the puncture is wiped with sterile gauze.

[0013] • Subsequent blood is absorbed into the first circle on the Guthrie paper without touching the heel. (At this time, very gentle pressure can be applied to the area surrounding the puncture site to increase blood flow, but the heel should not be squeezed too hard to prevent extracellular fluid from diluting the blood sample.)

[0014] • Make sure that each field where the sample will be taken is completely filled in and transferred to the reverse side.

[0015] • If the blood flow has stopped, the same area should not be punctured again, a different part of the foot or the other foot should be preferred.

[0016] • A blood sample should only be taken on one side of the Guthrie paper.

[0017] • The circles on the Guthrie paper should be completely filled with blood in turn. When the procedure is completed, the baby's foot is held above the level of the heart by applying light pressure on the puncture site with dry cotton wool and the bleeding is stopped.

[0018] • The Guthrie paper is allowed to dry on a dry, clean and flat surface at room temperature for at least 4 hours, and after drying, it is placed in an envelope, placed in the refrigerator in a moisture-proof place and sent to the laboratory within 24 hours (Care should be taken not to overlap the blood collection sites in the samples placed in the envelope).

[0019] Due to difficulties and disadvantages such as limitations and inadequacies of the solutions in the current technique, squeezing during heel blood collection, loss of time due to repetitive heel blood collection procedures, increase in the number of punctures with manual puncture of the heel and thus increase in pain, it has become necessary to make an improvement in the apparatus used for heel blood collection.

[0020] BRIEF DESCRIPTION AND THE AIM OF THE INVENTION

[0021] The invention relates to a heel blood collection pen which sequentially enables vacuuming, puncturing, wiping the first drop of blood, taking the blood into the tube and then impregnating the Guthrie paper. The heel blood collection pen subject to the invention has four different functions: vacuuming, puncturing, wiping the first drop of blood and taking the blood into the collection tube.

[0022] One object of the invention is to end the squeezing process for tissue perfusion during heel prick blood collection. The heel blood collection pen subject to the invention contains a vacuum head (2) and a vacuumizing piston (3) to stop the squeezing process and thus reduce the pain caused by the squeezing process.

[0023] Another object of the invention is to reduce behavioral and physiological distress in the infant and the number of punctures. In the invention, the use of a mechanical lancet (4) reduces the number of punctures, thus reducing behavioral and physiological distress in the infant. Another aim of the invention is to develop an equipment that will increase practicality for use in heel blood collection. A practical heel blood collection pen is provided due to the fact that the said pen has a single pen configuration in the main body of the pen, which is suitable for disinfection and reuse, in a rigid plastic structure, which serves to hold the parts that perform the functions of vacuuming, puncturing, wiping the first drop of blood and blood collection together. In addition, the invention is practical as it has been developed in pen format, making it easy to be practiced by the nurse.

[0024] Another aim of the invention is to save time by preventing repeated procedures in heel prick blood collection. In addition, thanks to the increase in the volume of the blood tube in the invention, there is no need for the nurse to perform repeated procedures during the blood collection and impregnation of the Guthrie paper, and the waste of time is eliminated.

[0025] FIGURE LIST

[0026] Figure 1. Main body of the pen

[0027] Definitions of the Numbers Given in the Figure

[0028] 1. Main body of the pen

[0029] 2. Vacuum head 3. V acuumizing pi ston

[0030] 4. Mechanical lancet

[0031] 5. Body for wiping the first blood

[0032] 6. Absorbent cotton wool

[0033] 7. Blood tube

[0034] DETAILED DESCRIPTION OF THE INVENTION

[0035] The invention relates to a heel blood collection pen which sequentially enables vacuuming, puncturing, wiping the first blood, collecting the blood into a tube and then impregnating to the Guthrie paper.

[0036] The subject of the invention is a heel blood collection pen, which comprises the following components:

[0037] The main body of the pen, which is made of rigid plastic, disinfectable and suitable for reuse, which is used to hold together the parts that perform the functions of vacuuming, puncturing, first blood wiping and blood collection (1),

[0038] - Disposable vacuum head (2), which is attached to the tip of the main body of the pen (1), which enables the vacuuming function to be performed, which is in direct contact with the skin (heel) and has a silicone structure,

[0039] A rigid plastic, disinfectable and reusable vacuumizing piston (3), which is attached to the midline-inner part of the main body of the pen (1), and which is necessary for the realization of the vacuuming function,

[0040] A mechanical lancet (4), which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), where the patient-specific needle is fixed, which is removable, which will perform a puncture function,

[0041] The body for wiping the first drop of blood (5) from the heel, which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), can be disinfected for reuse

[0042] - Removable disposable absorbent cotton wool (6) at the end of the body for wiping the first drop of blood (5),

[0043] A sterile, heparin or citrate-free, removable and disposable blood tube (7), which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), capable of holding a sufficient amount of blood (0.6 ml=6 dizyem) to fill the five regions on the Guthrie paper, In the heel blood collection pen subject to the invention, the main body of the pen (1) is a rigid plastic apparatus suitable for disinfection and reuse, which serves to hold together the parts that perform the functions of vacuuming, puncturing, first blood wiping and blood collection.

[0044] In one embodiment of the invention, the main body of the pen (1) has a length of 7 cm and a width (diameter) of 0.5 cm.

[0045] In determining the length of the main body (1) of the heel blood collection pen subject to the invention; since 5 ml injectors are mostly used in manual application in intramuscular injection applications, the height of these injectors was considered as the maximum reference level for the inventive pen in terms of the application comfort of the healthcare professional. For the width, the application area on the baby's heel was measured and the application area was determined as 1 cm. Considering the widths of the silicone vacuum heads to be attached to the end of the main body of the pen, the narrowest diameter was taken for the main body of the pen and the pen width was considered as 0.5 cm.

[0046] The vacuum head (2) contained in the heel blood collection pen subject to the invention is a disposable (patient-specific) part of the pen necessary for the realization of the vacuuming function. The vacuum head (2) is attached to the end part of the main body (1) of the pen. The vacuum head (2), which comes into direct contact with the skin (heel) and is made of silicone, soft and will not harm the baby, is available in several sizes.

[0047] In one embodiment of the invention, the vacuum head (2) measures 0.6 cm.

[0048] In another embodiment of the invention, the vacuum head (2) measures 0.8 cm.

[0049] In another embodiment of the invention, the vacuum head (2) measures 1 cm.

[0050] The vacuumizing piston (3) included in the heel blood collection pen subject to the invention is also necessary for the realization of the vacuuming function. The vacuumizing piston (3) is attached to the midline-inner part of the main body (1) of the heel blood collection pen subject to the invention. The mechanism is that of an injector. It is a rigid plastic apparatus suitable for disinfection and reuse.

[0051] In the heel blood collection pen subject to the invention, the vacuumizing piston (3) includes a piston head.

[0052] Since the vacuumizing piston (3) completely enters the main body of the pen and the piston head remains outside the pen body, the length of this part is 1 cm and the total length of the piston is 8 cm.

[0053] The mechanical lancet (4) included in the heel blood collection pen subject to the invention is used for performing the puncture function of the heel blood collection pen subject to the invention. The mechanical lancet (4) required for the puncture function is a separate structure planned to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1) in the heel blood collection pen subject to the invention. The upper body, to which the single-use and patient-specific needle is fixed, is made of rigid plastic that is suitable for disinfection and reusable. The activation and deactivation of the function can be realized by applying pressure on the button on the top or side once.

[0054] In the mechanical lancet (4) in the heel blood collection pen subject to the invention, the blue part of the needle is 1 cm and the needle tip length is 1 mm for premature infants or 2 mm for infants born at term.

[0055] The body for wiping the first blood (5) used for the function of wiping the first blood in the heel blood collection pen subject to the invention is disinfectable for reuse. The heel blood collection pen subject to the invention is in the form of a separate body, which enters at an angle of about 30° from the lateral surface of the main body of the heel blood collection pen. The body for wiping the first blood (5) contains a disposable absorbent cotton wool (6) at its end. The activation and deactivation of the first blood wiping function can be realized by applying pressure once on the button on the top or side (spring system) or by pushing / sliding system via the button on the side surface.

[0056] In the heel blood collection pen subject to the invention, there is a blood tube (7) in which the blood collection function is performed in a separate body so as to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1).

[0057] The blood tube (7) in the heel blood collection pen subject to the invention is in the same system as the other functions in terms of the feature of attaching and removing the pen. In other words, it is in the form of a spring system with a single pressure from the top or side, or a push / sliding system via the button / button on the side surface. The tip of the capillary blood tube (7) is in direct contact with the skin surface (heel) of the baby, and the other end has a piston tip that enters the tube.

[0058] The piston tip of the blood tube (7) is in the form of any material or rigid plastic that does not increase the internal pressure of the capillary tube.

[0059] During blood collection, the piston is pulled up slightly according to the amount of incoming blood, allowing the blood to move upwards in the tube with manual management such as a syringe. Although the capillary blood tube (7), which is for single use, is much thinner and smaller in volume in the known state of the art, in the heel blood collection pen subject to the invention, it has a volume that can take enough blood to fill five areas on the Guthrie paper (the amount of blood required for heel blood is 0.6 ml = 6 dizyem) and is sterile and does not contain citrate or heparin. After the blood collection process is over, the blood in the blood tube (7) removed from the pen is dripped onto the Guthrie paper by the health professional using a manually operated piston.

[0060] The pen has four functions: vacuuming, puncturing, wiping the first drop of blood and collecting the blood into the blood collection tube. Each function of the multifunctional pen has its own chamber with a sequential and manually manageable function of the tips. In other words, the function in each chamber is manually sent to and withdrawn from the application area sequentially. This application is realized by means of the button on the top or side of each lateral body.

[0061] The pen contains a mechanical lancet (4) to perform the puncture process, an absorbent cotton wool (6) to wipe the first drop of blood, and a sterile (heparin or citrate-free) blood tube (7) of appropriate size to collect the blood. In addition, two ends / functions are considered to be active in the invention.

[0062] Since the vacuuming function is on the midline, it can be actively used again when necessary during blood collection. In other words, if the blood flow decreases or if there is a decrease in blood supply due to a decrease in vacuuming, such as when the baby wiggles its foot, blood flow can be restored with a slight vacuuming. The ability to restore blood flow by suctioning is not a routine practice for all applications. Only when necessary, for example when blood flow is reduced, the inventive pen can be used simultaneously for each of the other three functions together with the vacuuming function. For this reason, the vacuuming function is positioned in the center line. Under normal conditions, the vacuuming function is used once as the first application. However, re-vacuuming can be performed if necessary.

[0063] All parts of the invention are formed in accordance with asepsis and disinfection. Thanks to the vacuum head (2) and the vacuumizing piston (3), it is not necessary to perform the squeezing application, which is the most painful stage frequently performed in routine applications for perfusion of the heel blood collection area, and instead performs the vacuuming process just before the puncture. In the invention, the vacuum head (2) has a cavity at the end which allows both the passage of the column (function) active in the pen and the vacuuming process to be applied when necessary (to maintain the negative pressure created in the first vacuuming). Vacuuming is therefore the first function of the pen and will be the stage that is used as needed throughout the procedure. The vacuum dimensions (in terms of height and width) are suitable for the procedure and the newborn. The pen is placed in the middle part of the vacuuming apparatus, is removable, and both the vacuum and the pen are formed in a content suitable for asepsis and disinfection for reuse. The mechanical lancet (4) is used for puncturing, which is the second function of the pen. Thanks to the mechanical lancet (4) used in the invention, the number of punctures in the heel is reduced and thus the pain caused by the puncture is reduced. Wiping the first blood from the heel is the third function of the pen. In the pen subject to the invention, absorbent cotton wool (6) is used to wipe the blood. Taking the blood into the tube and then impregnating to the Guthrie paper is the fourth function of the pen.

[0064] The method of application of the heel blood collection pen subject to the invention includes the following process steps: i. vacuuming by means of vacuum head (2) and vacuumizing piston (3) for perfusion of the heel blood collection site, ii. puncture of the relevant part using the mechanical lancet (4) to take heel blood, iii. wiping the first blood with absorbent cotton wool (6) at the end of the body for wiping the first blood (5), iv. blood collection into a blood tube (7) and subsequent impregnation on Guthrie paper

[0065] REFERENCES

[0066] 1. Bayrak, R., Unsal, A. (2022). Newborn Heel Prick Test Procedure Steps and Health Care Professionals, Tiirkiye Saghk Bilimleri ve Ara§tirmalan Dergisi, 5(2), 60-68. https: / / doi.org / 10.51536 / tusbad.1024146

[0067] 2. Britto, C. D., Rao Pn, S., Nesargi, S., Nair, S., Rao, S., Thilagavathy, T., Ramesh, A., & Bhat, S. (2014). PAIN— perception and assessment of painful procedures in the NICU. Journal of tropical pediatrics, 60(6), 422-427. biriN.

[0068] 3. Canadas, D. C., Perales, A. B., Martinez, R. G., & Carreno, T. P. (2021). The impact of

[0069] Nonpharmacological Interventions on Cortisol During Heel Lance Procedures on Preterm Infants: A Meta- Analysis Of RCTs. Pain management nursing: official journal of the American Society of Pain Management Nurses, 22(6), 798-805.

[0070] 4. Carbajal, R., (2017). Nonpharmacological Treatment of Neonatal Pain. Eds: Buonocore, G., Valerio Bellieni, C. In: Neonatal Pain Suffering, Pain, and Risk of Brain Damage in the Fetus and Newborn. Springer International Publishing. Second Edition.

[0071] 5. Chidambaram, A. G., Manjula, S., Adhisivam, B., & Bhat, B. V. (2014). Effect of Kangaroo mother care in reducing pain due to heel prick among preterm neonates: a crossover trial. The journal of maternal -fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 27(5), 488-490.

[0072] 6. Cong, X., Cusson, R. M., Walsh, S., Hussain, N., Ludington-Hoe, S. M., & Zhang, D. (2012). Effects of skin-to-skin contact on autonomic pain responses in preterm infants. The journal of pain, 13(7), 636-645.

[0073] 7. Cruz, M. D., Fernandes, A. M., & Oliveira, C. R. (2016). Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. European journal of pain (London, England), 20(4), 489-498. >

[0074] 8. International Association for the Study of Pain. “Terminology”. https: / / www.iasppain.org / resources / terminology / , Access date: 5.12.2022.

[0075] 9. Jeong, I. S., Park, S. M., Lee, J. M., Choi, Y. J., & Lee, J. (2014). The frequency of painful procedures in neonatal intensive care units in South Korea. International journal of nursing practice, 20(4), 398-407. htps: / / doi.Org / 10.1 111 / ijn.12202.

[0076] 10. Kerner, D., & I§ler, A. (2020). Evidence-based non-pharmacological nursing procedures for newborn pain management. Bahkesir Health Sciences Journal, 9(3), 197-204. ISSN: 2146- 9601- e ISSN: 2147-2238.

[0077] 11. Kurdahi Badr, L., Demeijian, T., Daaboul, T., Abbas, H., Hasan Zeineddine, M., & Charafeddine, L. (2017). Preterm infants exhibited less pain during a heel stick when they were played the same music their mothers listened to during pregnancy. Acta paediatrica (Oslo, Norway : 1992), 106(3), 438-445. https:. / / doi.org / 10.11 1 1 / apa.l 3666.

[0078] 12. Larsson, B. A., Tannfeldt, G., Lagercrantz, H., & Olsson, G. L. (1998). Venipuncture is more effective and less painful than heel lancing for blood tests in neonates. Pediatrics, 101(5), 882-886.

[0079] 13. Nist, M. D., Pickier, R. H., Steward, D. K., Harrison, T. M., & Shoben, A. B. (2019). Inflammatory mediators of stress exposure and neurodevelopment in very preterm infants: Protocol for the stress neuro-immune study. Journal of advanced nursing, 75(10), 2236-2245. https: / / doi.org / 10. I l l 1 / j an.14079.

[0080] 14. Pados, B. F., & Hess, F. (2020). Systematic Review of the Effects of Skin-toSkin Care on Short-Term Physiologic Stress Outcomes in Preterm Infants in the Neonatal Intensive Care Unit. Advances in neonatal care : official journal of the National Association of Neonatal Nurses, 20(1), 48-58. https: / / doi.org / 10. 1097 / ANC.0000000000000596.

[0081] 15. Riley, C., Spencer, B., Prater, L.S. (2020). “Normal Term Newborn”. Comprehensive Neonatal Nursing Care. Eds: Kenner, C., Altimier, L.B., Boykova, M.V. Springer Publishing Company, Sixth Edition.

Claims

CLAIMS1. Apractical heel blood collection pen comprising the following features:The main body of the pen (1), which is made of rigid plastic, disinfectable and suitable for reuse, which is used to hold together the parts that perform the functions of vacuuming, puncturing, first blood wiping and blood collection,- Disposable vacuum head (2), which is attached to the tip of the main body of the pen (1), which enables the vacuuming function to be performed, which is in direct contact with the skin (heel) and has a silicone structure,A rigid plastic, disinfectable and reusable vacuumizing piston (3), which is attached to the midline-inner part of the main body of the pen (1), and which is necessary for the realization of the vacuuming function,A mechanical lancet (4), which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), where the patient-specific needle is fixed, which is removable, which will perform a puncture function,The body for wiping the first drop of blood (5) from the heel, which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), can be disinfected for reuse,- Removable disposable absorbent cotton wool (6) at the end of the body for wiping the first drop of blood (5),A sterile, heparin or citrate-free, removable and disposable blood tube (7), which is structured to enter at an angle of approximately 30° from the lateral surface of the main body of the pen (1), capable of holding a sufficient amount of blood (0.6 ml=6 dizyem) to fill the five regions on the Guthrie paper.

2. A heel blood collection pen according to claim 1, characterized in that the main body of the pen (1) is made of a rigid plastic material that can hold together the parts that perform the functions of vacuuming, puncturing, first blood wiping and blood collection of the pen, and is suitable for disinfection and reuse.

3. A heel blood collection pen according to Claim 1, characterized in that the main body of the pen (1) has a length of 7 cm and a width (diameter) of 0.5 cm.

4. A heel blood collection pen according to Claim 1, characterized in that the vacuum head (2) measures 0.6 cm, 0.8 cm or 1 cm.

5. A heel blood collection pen according to Claim 1, characterized in that the length outside the main body of the pen (1) is 1 cm and the total length of the piston is 8 cm.

6. A heel blood collection pen according to Claim 1, characterized in that the length of the needle tip of the mechanical lancet (4) is 1 mm when used for preterm infants and 2 mm when used for term infants.

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