Device for protecting the hand of a medical professional when puncturing the umbilical cord of a newborn
Patent Information
- Application Number
- EP2024710081
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-03-15
- Filing Date
- 2024-03-08
- Publication Date
- 2025-12-10
AI Technical Summary
Current methods for collecting umbilical cord blood postpartum are challenging due to the risk of puncture injuries for medical staff and potential harm to the mother and child, especially with unpredictable movements, and existing devices either restrict blood flow or do not reliably prevent injuries.
A protective device with an umbilical cord groove and lateral wings for hand protection, combined with handle strips that allow ergonomic gripping, enabling safe puncture of the umbilical cord without restricting blood flow or requiring clamps, and accommodating various hand sizes and orientations.
The device effectively protects medical staff from puncture injuries and ensures accurate blood sampling by allowing secure handling and puncture at any point along the umbilical cord groove, reducing the risk of accidents and maintaining blood flow integrity.
Smart Images

Figure EP2024056179_19092024_PF_FP_ABST
Abstract
Description
[0001] Protective device for the hand of a medical staff member during the puncture of the umbilical cord of a newborn
[0002] The invention relates to a protective device for the hand of a medical personnel when puncturing an umbilical cord of a newborn.
[0003] According to current regulations and guidelines, it is necessary and common practice, primarily for forensic reasons, to determine the pH value of the umbilical cord blood postpartum in order to obtain information about the postnatal care of the newborn. The later the umbilical cord blood is collected, the more distorted the value is. Therefore, the umbilical cord is currently cut immediately after birth. This problem can be avoided by taking the umbilical cord blood from the pulsating umbilical cord for pH determination. Studies have shown that after the umbilical cord has stopped pulsating, the blood gas values result in an acidotic (acidic) value due to the change in circulatory system and the increasingly persistent blood flow in the umbilical cord vessels. This value does not correspond to the actual situation of the child and suggests acidosis (excess acidity).
[0004] Studies have shown that newborns with delayed cord cutting have higher iron stores, which are usually sufficient until the first year of life. Furthermore, newborns with delayed cord cutting receive more stem cells as a result of these measures, which in turn has a positive effect on the immune system, blood formation, and the development of the newborn's central nervous system (CNS). Higher hemoglobin levels and improved neurological and fine motor development have been observed.
[0005] Due to the birth environment and the time constraints, blood sampling during a late cord cutting procedure presents medical personnel with a significant challenge. The mother and / or child may be moving, and the umbilical cord and its surroundings are slippery and difficult to handle due to various fluids such as amniotic fluid or blood. Therefore, there is a risk that a) the medical personnel could injure themselves with the syringe while taking the sample, or b) that both mother and child could be injured. Such injuries also pose an increased risk of infection. In this regard, reference is also made to EU Directive 2010 / 32 / EU on the prevention of stab and cut injuries in the healthcare sector and the Technical Rules for Biological Agents (TRBA) 250.
[0006] To make the collection of umbilical cord blood samples safer for medical personnel, various devices are known from the prior art. For example, WO 01 / 76660 A2 discloses a protective device for holding the umbilical cord during umbilical cord puncture. The device is groove-shaped and protects, in particular, against injuries in the event of an accidental puncture of the umbilical cord. The umbilical cord is placed in the groove-shaped protective device and secured by the medical personnel with a finger, particularly a thumb. However, puncture injuries caused by unexpected movements of the mother and / or child are not reliably prevented, particularly since the finger is positioned in close proximity to the puncture site for fixation.
[0007] FR 2 609 635 also discloses a groove-shaped protective device, but in this case, the umbilical cord is secured to the protective device at the distal and proximal ends using clamps. Therefore, the umbilical cord does not need to be additionally secured with a finger during puncture. However, the umbilical cord must first be secured using the clamps before it can be punctured. Furthermore, the clamps at least partially impede blood flow through the umbilical cord, which can lead to distorted blood test results. Similar protective devices are known from US Pat. Nos. 5,690,646 A and 5,575,795 A.
[0008] FR 2 954 085 discloses a device for collecting placental blood after the umbilical cord has been severed from the newborn. According to FR 2 954 085, sampling immediately after birth is not provided for. Furthermore, the disclosed device includes clamps for clamping the umbilical cord, which can lead to inaccurate blood results.
[0009] WO 2014 / 143664 A1 discloses a clamp that is clamped onto the umbilical cord. The clamp includes a guide for the puncture needle. A disadvantage of this device is that the puncture needle must be inserted into the guide. Furthermore, the clamp covers the puncture site, making it difficult for medical personnel to check whether the puncture needle has already been inserted into the umbilical cord blood vessel or whether the umbilical cord has also been punctured. Furthermore, EP 2 913 004 A1 discloses a groove-shaped protective device with a fastening section and a puncture section. A gripping part is arranged in the fastening section on the underside of the groove-shaped protective device for securing the device between two fingers of one hand. With another finger, preferably the thumb, the umbilical cord is secured to the upper side of the groove-shaped protective device. The puncture section is arranged adjacent to the fastening section.This means that a medical staff member's finger is in close proximity to the puncture site. Furthermore, puncture injuries caused by movements of the mother and / or newborn cannot be reliably prevented.
[0010] WO 2011 / 093781 A1 discloses another groove-shaped protective device for puncturing an umbilical cord. The groove is formed laterally by two curved hollow elements that serve as gripping elements. However, the device is held in the palm of the hand such that the fingers and thumb are positioned on the upper side adjacent to the umbilical cord groove and are therefore not protected from needle punctures.
[0011] The invention is therefore based on the object of protecting medical personnel as well as mother and child from puncture injuries during the umbilical cord puncture of a newborn still connected to the mother via the umbilical cord, in particular in the case of unforeseeable movements of the mother and / or child, without influencing the blood results.
[0012] The object is achieved according to the invention by a protective device for the hands of medical personnel when puncturing the umbilical cord of a newborn, comprising: an umbilical cord groove for receiving the umbilical cord of the newborn, two wings arranged at the upper edge of the umbilical cord groove as hand protection, wherein the wings each extend laterally away from the umbilical cord groove, and two gripping strips (6) which each extend parallel to the umbilical cord groove (4), wherein the gripping strips (6) are arranged in the lower region on opposite sides of the umbilical cord groove (4) and further extend in the depth direction of the umbilical cord groove (4) such that the lower edge of the umbilical cord groove (4) is arranged completely between the two gripping strips. The protective device according to the invention can be held in one hand by medical personnel using the two gripping strips.The upper section of the umbilical cord groove and the gripping strips arranged in the lower section of the umbilical cord groove together serve as gripping elements for the protective device according to the invention. The lower section of the umbilical cord groove, which is arranged between the two gripping strips, runs through the palm of the medical personnel's hand, which corresponds to a particularly ergonomic position for puncturing the umbilical cord. The umbilical cord groove prevents puncture injuries caused by an unintentional piercing of the umbilical cord. The wings arranged at the upper edge of the umbilical cord groove protect the medical personnel's hand from puncture injuries caused by the needle slipping or other unintentional movements, for example, caused by movements of the mother or newborn.The medical staff's holding hand is thus located below and to the side of the umbilical cord groove and is protected from above by the lateral wings. This arrangement allows the umbilical cord to be punctured at any point along the umbilical cord groove, particularly at a location where a corresponding umbilical cord vessel is clearly visible for blood sampling. In contrast, in the prior art according to EP 2 913 004 A1, for example, the umbilical cord can only be punctured in the puncture area of the umbilical cord groove, which is also in close proximity to the attachment section where the medical staff secures the umbilical cord to the top of the umbilical cord groove with a finger.
[0013] Since the side wings are located in the upper area of the umbilical cord groove and extend laterally from the umbilical cord groove, while the handle bars are located in the lower area of the umbilical cord groove and extend downwards, the hands of the medical staff are protected by the side wings.
[0014] In a preferred variant of the invention, the two handle bars each extend diagonally laterally from the umbilical groove, so that the upper region of the umbilical groove below the lateral wings and the corresponding diagonal handle bar form a V-shaped handle region along the umbilical groove.
[0015] According to a preferred variant of the invention, the two wings extend over the entire length of the umbilical cord groove. This protects the medical personnel's holding hand from puncture injuries, regardless of where the umbilical cord is punctured.
[0016] According to an advantageous variant of the invention, the two handle bars extend over the entire length of the umbilical cord groove. Such handle bars enable particularly good handling of the protective device according to the invention, in particular a secure hold in the hand of the medical personnel. The medical personnel can thus grasp the protective device according to the invention along its entire length, regardless of the size of the medical personnel's hand, since everyone can grip the protective device according to the invention wherever it is comfortable for them. Furthermore, the protective device according to the invention can be placed stably on the two handle bars, in particular since the lower end of the umbilical cord groove is arranged entirely between the handle bars. The curved lower end of the umbilical cord groove has no influence on the placement of the protective device, since the protective device is placed entirely on the two handle bars.
[0017] The two handles have the additional advantage that the device according to the invention can be used equally by right- and left-handed people.
[0018] In an expedient variant of the invention, the grip strips each have at least one lateral indentation for a finger of the medical personnel's hand. These indentations allow the protective device according to the invention to be held even more securely in the hand of the medical personnel. In particular, the indentations are arranged in the proximal third of the protective device, for example, to accommodate the thumb and index finger of the medical personnel's hand. Proximal within the meaning of the invention is the end of the protective device facing the nut. Distal within the meaning of the invention is the end of the protective device facing the medical personnel.
[0019] According to a particularly advantageous variant, the umbilical cord groove is angled toward the proximal end in the direction of the umbilical cord groove's depth. In particular, the angle is rounded rather than square. This angle ensures that the umbilical cord is better held in the umbilical cord groove, and the umbilical cord is not kinked at the ends of the protective device, but rather supported in the area of its normal course. The angle of the proximal end to the distal end of the umbilical cord groove is preferably between 30 degrees and 60 degrees, particularly between 40 degrees and 50 degrees.
[0020] According to a variant of the invention, the lateral wings have the greatest lateral extent at the distal end and become continuously narrower towards the proximal end. During intended use of the device according to the invention, the palm of the medical personnel's hand is arranged at the distal end, while the fingertips are arranged at the proximal end. Since the fingertips are overall narrower than the palm of the hand and can also be held one above the other, the lateral wings can be narrower at the proximal end than at the distal end and still provide the same level of protection. A protective device that tapers towards the proximal end, i.e. a protective device that narrows towards the proximal end, is less bulky and more ergonomic to handle. Furthermore, the protective device can be better placed in the mother's groin.
[0021] In a variant according to the invention, the umbilical cord groove has a constriction at the distal end and / or the proximal end to secure the umbilical cord. In particular, the constriction at the distal end and / or the proximal end is V-shaped. Such a constriction helps secure the umbilical cord in the umbilical cord groove through its own weight, without clamping the umbilical cord or reducing blood flow to the umbilical cord.
[0022] According to a preferred variant of the invention, the inside of the umbilical cord groove is softer than a puncture needle, so that the puncture needle can be fixed in the inside of the umbilical cord groove when piercing the umbilical cord. In particular, the inside of the umbilical cord groove is designed to be flexible for this purpose. This has the advantage that after puncture and sample collection, the puncture needle can be pierced through the umbilical cord and fixed in the inside of the umbilical cord groove. The puncture needle can remain there until the umbilical cord has been severed and disposed of. This also reliably prevents puncture injuries after sample collection. For example, the inside of the umbilical cord groove has an extra coating or the umbilical cord groove is made of a softer material, particularly plastic, but has a sufficient wall thickness to prevent puncture with the puncture needle.
[0023] In addition, several blood samples are usually taken from the umbilical cord. For example, the umbilical artery is punctured first to determine the arterial pH. The umbilical vein can then be punctured to determine the venous pH. Additionally, blood can be drawn from the umbilical cord for an EDTA tube for blood typing or serum for serology. The puncture needles used for this purpose can be secured in the softer inner lining of the umbilical cord groove, which is advantageous.
[0024] A protective device according to the invention for the hand of medical personnel when puncturing an umbilical cord in a newborn has, for example, a length of between 10 cm and 20 cm, in particular approximately 15 cm. The umbilical cord groove of the protective device according to the invention is curved, egg-shaped, polygonal or the like. The umbilical cord groove preferably has an upper width of 15 mm to 25 mm, in particular approximately 20 mm. The lateral wings have a width of 1.0 cm to 5.0 cm, preferably approximately 2.5 cm. In particular, the lateral wings have the greatest lateral extent at the distal end and become continuously narrower towards the proximal end. For example, the lateral wings have a width of 2.5 cm to 5.0 cm at the distal end and taper to 1.0 cm to 2.5 cm towards the proximal end.
[0025] The invention is explained in more detail below with reference to exemplary embodiments illustrated in the figures. They show:
[0026] Fig. 1 is a perspective top view of a protective device according to the invention for the hand of a medical personnel during the puncture of an umbilical cord of newborns,
[0027] Fig. 2 is a perspective view from below of the protective device according to the invention from Fig. 1,
[0028] Fig. 3 is a side view of the protective device according to the invention from Figs. 1 and 2, and Fig. 4 is a protective device according to the invention for the hand of a medical personnel when puncturing an umbilical cord of a newborn.
[0029] Fig. 1 shows a perspective top view of a protective device 1 according to the invention for the hand 2 of a medical personnel during the puncture of an umbilical cord 3 of a newborn. The protective device 1 comprises an umbilical cord groove 4 for receiving the umbilical cord of the newborn and two wings 5 arranged at the upper edge of the umbilical cord groove 4 as hand protection. The wings 5 extend laterally away from the umbilical cord groove 4 when the protective device 1 is in use.
[0030] The protective device 1 further comprises two gripping strips 6, each extending parallel to the umbilical cord groove 4. The gripping strips 6 are arranged in the lower region on opposite sides of the umbilical cord groove 4 and further extend in the depth direction of the umbilical cord groove 4, so that the lower edge of the umbilical cord groove 4 is arranged entirely between the two gripping strips 6. The gripping strips 6, together with the respective upper region of the umbilical cord groove 4, form a gripping area for the medical personnel. During use of the protective device 1 according to the invention, the hand of the medical personnel is protected from puncture needle injuries from above by the lateral wings 5.
[0031] The protective device 1 according to the invention has, for example, a length between 10 cm and 20 cm, in particular approximately 15 cm. The umbilical cord groove 4 of the protective device 1 is, for example, curved, U-shaped, or polygonal and expediently has an upper width of 15 mm to 25 mm, in particular approximately 20 mm. According to the exemplary embodiment shown in Fig. 1, the umbilical cord groove has a constriction 10 at the distal end 9 and at the proximal end 8 for securing the umbilical cord 3. For example, this constriction 10 is V-shaped. The constriction 10 ensures better fixation of the umbilical cord 3 in the umbilical cord groove 4, wherein the constriction 10 is designed such that the umbilical cord 3, and in particular the blood flow through the umbilical cord 3, is not clamped off.
[0032] As can be seen from Fig. 1, the two wings 5 extend over the entire length of the umbilical groove 4. The two wings 5 have a greater lateral extent at the distal end 9 of the protective device 1 than at the proximal end 8. In particular, the lateral wings 5 become continuously narrower towards the proximal end 8. For example, the two wings 5 have a width of 2.5 cm to 5.0 cm at the distal end 9 and a width of 1.0 cm to 2.5 cm at the proximal end.
[0033] According to a preferred variant of the invention, the inside of the umbilical cord groove 4 is designed to be softer than a puncture needle 11, so that the puncture needle 11 can be fixed in the inside of the umbilical cord groove 4 when piercing the umbilical cord 3 and, at the same time, the escape of umbilical cord blood can be reduced. In particular, the inside of the umbilical cord groove 4 is designed to be flexible for this purpose. This has the advantage that after the puncture and sample removal, the puncture needle 11 can be pierced through the umbilical cord 3 and fixed in the inside of the umbilical cord groove 4. The puncture needle 11 can remain there until the umbilical cord 3 has been severed and disposed of. This also reliably prevents puncture injuries after the sample removal.For example, the inside of the umbilical cord groove 4 has an extra coating or the umbilical cord groove 4 is made of a softer material, in particular plastic, but has a sufficient wall thickness to prevent puncture with the puncture needle 11.
[0034] Fig. 2 shows a perspective view from below of the protective device 1 according to the invention from Fig. 1 . As can be seen in particular from Fig. 2, the two gripping strips 6 extend almost over the entire length of the umbilical groove 4 or the protective device 1 . The two gripping strips 6 each have an indentation 7, for one finger of the hand 2 of the medical personnel, in particular the thumb and index finger of the hand 2. The indentations 7 are arranged approximately in the proximal third of the protective device 1.
[0035] Fig. 3 shows a side view of the protective device 1 according to the invention from Figs. 1 and 2. It is particularly clear from Fig. 3 that the umbilical groove 4 is angled toward the proximal end 8 in the depth direction of the umbilical groove 4, i.e., downwards in the position of use of the protective device 1. According to the invention, the angle of the proximal end 8 to the distal end 9 of the umbilical groove 4 is between 30 degrees and 60 degrees, in particular between 40 degrees and 50 degrees.
[0036] From Fig. 3, it can also be seen that the indentations 7 on the gripping strips 6 are arranged approximately in the region of the bend and that the protective device 1 according to the invention can be stably placed on the two gripping strips 6. Since the two gripping strips are arranged on opposite sides of the umbilical cord groove 4, the umbilical cord 3 can also be punctured in the placed state, in particular without the protective device 1 tipping sideways.
[0037] Fig. 4 shows a protective device 1 according to the invention for the hand 2 of a medical personnel during the puncture of an umbilical cord 3 of a newborn. The medical personnel can hold the protective device 1 according to the invention in one hand 2 by means of the gripping strips 6 arranged below the two wings 5 in the position of use. The umbilical cord 3 of the newborn is placed in the umbilical cord groove 4 and can be punctured with the other hand of the medical personnel using a puncture needle 11. The umbilical cord groove 4 protects the hand 2 of the medical personnel from puncture injuries caused by piercing the umbilical cord 3. The lateral wings 5 protect the hand
[0038] 2 of the medical personnel from puncture injuries caused by slipping or the like from the umbilical cord groove 4, for example due to unforeseen movements of the mother and / or the newborn. Since the hand 2 for holding the protective device 1 according to the invention is arranged completely below the wings 5, the umbilical cord placed in the umbilical cord groove 4 can
[0039] 3 anywhere along the entire length of the umbilical cord groove 4 without the risk of puncture injuries.
[0040] List of reference symbols
[0041] 1 protective device
[0042] 2 hands
[0043] 3 Umbilical cord
[0044] 4 Umbilical groove
[0045] 5 wings (hand protection)
[0046] 6 Handle bar
[0047] 7 Recess of the handle bar
[0048] 8 proximal end
[0049] 9 distal end
[0050] 10 Constriction
[0051] 11 Puncture needle
Claims
Claims 1. A protective device (1) for the hand (2) of a medical personnel when puncturing an umbilical cord (3) of a newborn, comprising: an umbilical cord groove (4) for receiving the umbilical cord (3) of the newborn, two wings (5) arranged on the upper edge of the umbilical cord groove (4) as hand protection, wherein the wings (5) each extend laterally away from the umbilical cord groove (4), and two handle bars (6) which each extend parallel to the umbilical cord groove (4), wherein the handle bars (6) are arranged in the lower region on opposite sides of the umbilical cord groove (4) and further extend in the depth direction of the umbilical cord groove (4) such that the lower edge of the umbilical cord groove (4) is arranged completely between the two handle bars (6).
2. Protection device (1) according to claim 1, wherein the two wings (5) extend over the entire length of the umbilical groove (4).
3. Protection device (1) according to claim 1 or claim 2, wherein the two grip strips (6) extend over the entire length of the umbilical groove (4).
4. Protective device (1) according to one of claims 1 to 3, wherein the grip strips (6) each have at least one lateral indentation (7) for a finger of the hand (2) of the medical personnel.
5. Protection device (1) according to one of claims 1 to 4, wherein the umbilical groove (4) is angled towards the proximal end (8) in the depth direction of the umbilical groove (4).
6. Protection device (1) according to claim 5, wherein the angle of the proximal end (8) to the distal end (9) of the umbilical groove (4) is between 30 degrees and 60 degrees, in particular between 40 degrees and 50 degrees.
7. Protection device (1) according to one of claims 1 to 6, wherein the lateral wings (5) have the greatest lateral extent at the distal end (9) and become continuously narrower towards the proximal end (8).
8. Protection device (1) according to one of claims 1 to 7, wherein the umbilical cord groove (4) has a constriction (10) at the distal end (9) and / or at the proximal end (8) for fixing the umbilical cord (3).
9. Protection device (1) according to claim 8, wherein the constriction (10) at the distal end (9) and / or proximal end (8) is V-shaped.
10. Protection device (1) according to one of claims 1 to 9, wherein the inside of the umbilical cord groove (4) is softer than a puncture needle (11), so that the puncture needle (11) can be fixed in the inside of the umbilical cord groove (4) when piercing the umbilical cord (3).