Devices to assist with umbilical catheter placement in premature infants and newborns

Abstract

The present invention relates to a device (1) for assisting in the placement of an umbilical cord catheter (2) in a preterm infant or newborn (3), comprising: a first leg (4) and a second leg (5), wherein each of the first and second legs (4,5) has a semi-cylindrical groove (7) located in a region of a first end (6) and is connected to each other by a spring member (9) in a region of a second end (8), wherein the spring member (9) holds the first and second legs (4,5) in a first working state under the action of a spring force, wherein the respective first ends (6) of the first and second legs (4,5) are spaced apart from each other, and wherein the first and second legs (4,5) can be rotated to a second working state against spring resistance, wherein the respective first ends (6) of the first and second legs (4,5) are arranged to be close to each other, wherein the semi-cylindrical grooves (7) in the regions of the respective first ends (6) of the first and second legs (4,5) together form a cylindrical container (10) for placing the umbilical cord (11) of the preterm infant or newborn (3) in the second working state.

Description

Technical Field

[0001] This invention relates to a device for assisting in the placement of an umbilical catheter in premature infants and newborns, particularly a device for inserting into the umbilical vessels of premature infants and newborns. Background Technology

[0002] During the initial care of preterm infants or newborns, vascular access may be required for immediate administration of medications or fluids. It is especially important that, in resuscitation situations, the initial care of preterm infants and newborns must be very rapid and safe.

[0003] In existing technologies, three different vascular access methods are known to be frequently used: umbilical cord catheter, peripheral venous access, and intraosseous access (ioaccess). All access methods are placed by experienced personnel. This requires extensive practice and experience from medical staff. Especially in the first option, several people are busy placing the vascular access simultaneously. This often creates space problems for preterm infants and newborns.

[0004] Rapid placement of peripheral venous catheters (PVKs) is performed by specially trained and experienced personnel. However, this placement is often not smooth, and it becomes more difficult the more preterm or neonatal infant is small or weak. Catheter insertion is particularly challenging during resuscitation. Possible puncture sites include the dorsum of the hand, foot, head veins, and elbow veins. In very small preterm infants and those with poor circulation, peripheral venous access is often impossible.

[0005] As an alternative approach, the intraosseous approach (ioapproach) can be performed through the proximal tibia. However, the intraosseous approach is only permitted in infants weighing over 3000 grams and carries additional risks such as bone injury, inflammation, and lower leg bone growth disorders. Currently, however, it is technically easier and generally much faster to insert an intraosseous approach than through an umbilical cord catheter.

[0006] Another alternative route is the umbilical cord catheter. In this case, the umbilical vessel is fitted with a catheter or cannula. The vessel can be an umbilical vein or an umbilical artery. For critically ill preterm infants and newborns, intravenous or arterial access is crucial in the first few minutes after birth for the administration of volume boluses, glucose, and emergency medications such as epinephrine. Otherwise, it can lead to sequelae such as hypotension, hypoglycemia, or persistent bradycardia.

[0007] The main challenge in placing an umbilical vein catheter (UVC) or umbilical artery catheter (UAC) is identifying the vessel and, more importantly, having the lumen of the vessel visible during preparation. With current technology, this can be addressed, for example, by manually unfolding the umbilical cord using two surgical forceps. This requires at least one person to unfold the umbilical cord so that another person can place the catheter.

[0008] Therefore, placing an umbilical cord catheter has two main drawbacks. First, it requires at least two experienced physicians to coordinate the placement. These physicians actively study the umbilical area, leading to limited space around the premature infant and newborn. Second, it demands extensive experience from the attending physician. The placement is often technically very difficult or yields very frustrating results.

[0009] To overcome these two drawbacks, WO 2018 / 202844 A1 discloses a medical device for inserting a catheter into the umbilical cord vessels of a preterm infant, the device having a longitudinal axis, a proximal end, and a distal end. The proposed device is equipped with a sheath to enclose a portion of the umbilical cord. The device includes a clamping device for holding the umbilical cord, a cutting device for cutting the umbilical cord to form an umbilical interface, and a hooking device for widening the umbilical interface. The device clamps, separates, and unfolds the umbilical cord to place the umbilical catheter. However, the disadvantages of this medical device are its complex structure and high manufacturing cost. Although the device is reusable, sterilization is required after each use, which is very expensive, especially given the large number of moving parts involved. Another drawback is the significant variation in the location and anatomical shape of the umbilical cord vessels, making the solution described in the aforementioned patent virtually impossible to implement. Summary of the Invention

[0010] Therefore, the object of the present invention is to disclose a novel medical device for inserting a catheter into an umbilical cord blood vessel, which simplifies the difficulty of inserting a catheter through the umbilical cord blood vessel and avoids the disadvantages of known medical devices in the prior art.

[0011] According to the present invention, this problem is solved by a device for assisting in the placement of umbilical cord catheters in preterm infants and newborns, the device comprising:

[0012] The first leg and the second leg,

[0013] The first leg and the second leg each include a semi-cylindrical recess located in the first end region, and are connected to each other in the second end region by a spring element.

[0014] The spring element holds the first and second legs in a first working state by spring force, in which the first ends of the first and second legs are spaced apart from each other. The first and second legs can overcome spring resistance to transition to a second working state, in which the first ends of the first and second legs are positioned close to each other.

[0015] The semi-cylindrical grooves in the first end regions of the first and second legs together form a cylindrical receptacle, which is used to place the umbilical cord of premature infants and newborns in the second working state.

[0016] The device of this invention is particularly simple in design because only two movable legs are connected to each other by springs. In the second operating state, the umbilical cord is fixed inside the cylindrical container. In the second operating state, the distal edges of the adjacent first and second legs serve as guides for a scalpel to cut the umbilical cord at the distal edge of the device of this invention. This results in a particularly straight cutting edge, and it has been found that, because the blood vessels in the umbilical cord are clearly visible and catheters can be easily inserted, such a cutting edge eliminates the need to unfold the umbilical cord, which is required by the prior art.

[0017] The device of this invention allows for easy and rapid insertion of an umbilical cord catheter into the umbilical vessels of premature infants and newborns. In this first working state, the umbilical cord is positioned between the first and second legs of the device, specifically within a container at the first end of the first and second legs during compression, thus transitioning to the second working state. Once the umbilical cord is secured within the formed cylindrical container in the second working state, it can be cut with a scalpel guided along the distal edge of the device to achieve a clean cut. The catheter can then be inserted into the intended vessel of the premature infant's or newborn's umbilical cord. If the device is then released, it automatically returns to the first working state, in which the first and second legs separate to release the umbilical cord. To prevent leakage of blood into vessels never before inserted into the catheter, the umbilical cord can be tied off. This also secures the catheter within the clamped vessel, preventing further displacement.

[0018] The device of the present invention is particularly simple in design, especially lacking moving parts such as rotating blades or needle hooks. Therefore, the device of the present invention can be easily sterilized. Furthermore, the device of the present invention can also be manufactured without difficulty as a disposable product and disposed of after use, and its simple structure results in low manufacturing costs, thus avoiding the disadvantages of the prior art.

[0019] According to an advantageous embodiment of the invention, the device includes a locking device for locking the device in the second operating state. This means that the user does not need to overcome spring resistance to keep the device in the second operating state; however, the device is locked in this second operating state. Therefore, the user can fully concentrate on cutting the umbilical cord and placing the umbilical catheter. Preferably, the locking device automatically locks when the user moves the device to the second operating state.

[0020] According to a preferred embodiment of the invention, the locking component is designed to be detachable, particularly as a latching mechanism, so that the device can be removed again after the umbilical catheter has been placed. For this purpose, the latching mechanism is removed, for example, by moving the locking pin.

[0021] According to an embodiment of the invention, a locking member is formed at the first end of the first and second legs. Specifically, a first portion of the locking member is formed at the first end of the first leg, and a second portion is formed at the first end of the second leg. Therefore, particularly, the first ends of the first and second legs are firmly fixed relative to each other by the locking member, specifically, within the region of the cylindrical container for the umbilical cord formed in the second operating state. Thus, the umbilical cord is firmly fixed inside the container because the first ends of the first and second legs cannot move due to the locking member. For example, the first end of the first leg has an eyelet, while the first end of the second leg has a detent (protrusion) that engages with the eyelet in the second operating state.

[0022] According to a particularly preferred embodiment of the invention, the device includes an elevation at its distal end, which, in a second operating state, is located within the cylindrical container region of the umbilical cord. When the umbilical cord is cut, the elevation acts as a counter-bearing blade. The scalpel is guided along the distal edge of the device to cut the umbilical cord. The elevation is positioned behind the umbilical cord along the cutting direction to support the cord during cutting, thus facilitating the process.

[0023] According to a preferred embodiment of the invention, the upright plate is divided into two parts, with a portion of the upright plate disposed on each of the first and second legs. In the second operating state, the two portions of the upright plate are arranged adjacent to each other. Generally, for safety reasons, the incision should never be directly facing the user's body. In this case, this means that the incision for cutting the umbilical cord faces the first end of the device. Therefore, the upright plate must be located at the first end of the device, preferably in the direction of the umbilical cord cutting behind the cylindrical container. However, in this area, the first and second legs are separated from each other in the first operating state so that the umbilical cord can be retained in the device. Therefore, each leg preferably has a portion of the upright plate, so that they together form the upright plate in the second operating state.

[0024] According to an advantageous embodiment of the invention, semi-circular members are arranged at the distal ends of each portion of the upright plate. These semi-circular members are axially aligned with the semi-cylindrical grooves of the first and second legs. The two semi-circular members form a circular container in the second working state to secure the umbilical cord of premature infants and newborns. In the second working state, the circular container is axially aligned with and spaced apart from the cylindrical container, thereby creating a cutting channel between the cylindrical and circular containers. Therefore, the umbilical cord of the premature infant is secured below the cutting channel by the cylindrical container and simultaneously secured above the cutting channel by the circular container. This makes umbilical cord cutting particularly easy.

[0025] According to one embodiment of the invention, the upright plate or portions thereof are connected to the first and / or second leg of the device via a predetermined breaking edge. Therefore, the upright plate can be easily separated from the device after the umbilical cord is cut by simple cutting. This prevents the upright plate or its attached portions (such as the semi-circular member) from obstructing catheter insertion into the umbilical vessels.

[0026] According to another embodiment of the invention, the semi-cylindrical groove in the first operating state and the cylindrical container in the second operating state are conical, with the cone gradually widening from the proximal end to the distal end of the device. Thus, the umbilical cord is particularly well secured within the cylindrical container. Furthermore, for example, this compresses the blood vessels in the umbilical cord into the proximal region, i.e., the narrower area of ​​the cone, so that after the umbilical cord is cut, little or no blood escapes from the umbilical vessels. The cone is designed to allow the catheter to be deeply inserted into the umbilical vessels, thereby enabling access to the vascular system of premature infants and newborns.

[0027] According to an embodiment of the invention, the semi-cylindrical groove in the first working state and the cylindrical container in the second working state have grooves inside, particularly with openings to form a lamellae. This further improves the fixation of the umbilical cord within the cylindrical container.

[0028] According to one embodiment of the invention, the first and second legs each have outwardly extending wing plates at their distal ends, serving as finger guards. These can protect the user's fingers from cuts when the umbilical cord is cut.

[0029] According to an advantageous embodiment of the invention, the spring element is circular, open in a first operating state, and closed in a second operating state. This allows the spring element to be easily manufactured and integrated into the device. Due to the diameter of the circular spring element, the spring force can be adjusted in advance.

[0030] According to an advantageous embodiment, the device of the present invention is formed in one piece. The advantage of a one-piece device is that it is easy to sterilize. In particular, such simple one-piece devices are inexpensive to manufacture, and therefore they are preferably designed as disposable products because the cost of manufacturing the device is cheaper than the cost of sterilizing it.

[0031] Preferably, the device of the present invention is made of plastic.

[0032] For better handling, for example, the first and second legs can have grooved gripping surfaces. This improves grip strength.

[0033] Preferably, the device according to the invention is manufactured and stored according to different diameters of the cylindrical container in the second operating state, so that in an emergency, a device of the appropriate diameter for the current umbilical cord can be quickly selected. For example, the diameter of the cylindrical container in the second operating state is 5 mm to 15 mm, particularly 7 mm, 9 mm or 11 mm.

[0034] The present invention will now be described in more detail with reference to the embodiments shown in the accompanying drawings. The drawings are as follows: Attached Figure Description

[0035] Figure 1 This is a perspective view of an embodiment of the device of the present invention, used to assist in the placement of umbilical cord catheters in premature infants and newborns during a first operating state.

[0036] Figure 2 for Figure 1 Top view of the device shown.

[0037] Figure 3 This is a perspective view of an embodiment of the device of the present invention, showing the second working state, where the umbilical cord is fixed before being cut.

[0038] Figure 4 for Figure 3 The perspective view of the device shown illustrates the situation after umbilical cord severance and removal of the upright plate, and

[0039] Figure 5The placement of the umbilical cord catheter is shown, indicating that the device of the present invention has been removed. Detailed Implementation

[0040] Figure 1 This is a perspective view of an embodiment of the device 1 of the present invention, which is used to assist in the placement of an umbilical cord catheter 2 in premature infants and newborns 3. Figure 2 for Figure 1 The diagram shows a top view of device 1. Device 1 includes a first leg 4 and a second leg 5. Each of the first leg 4 and the second leg 5 has a semi-cylindrical groove 7 in the region of the first end 6. In the region of the second end 8, the first leg 4 and the second leg 5 are connected to each other by a spring member 9.

[0041] The spring member 9 holds the first leg 4 and the second leg 5 in a first working state by means of the inherent spring force. In this working state, the first ends 6 of the first leg 4 and the second leg 5 are separated from each other. Figure 1 The first operating state of device 1 is shown.

[0042] The first leg 4 and the second leg 5 switch to a second working state by overcoming spring resistance. In this working state, the first ends 6 of the first leg 4 and the second leg 5 are arranged close to each other. For example, Figure 3 and Figure 4 The second operating state of the device 1 of the present invention is shown.

[0043] according to Figure 1 In a first embodiment, the device 1 includes a locking member 12 for locking the device 1 in a second operating state. In this first embodiment, the locking member 12 is designed as a releasable latching connection. Designed as a snap-in connection, the locking member is located at the first end 6 of the first leg 4 and the second leg 5, wherein a first portion 13 of the locking member 12 is located at the first end 6 of the first leg 4, and a second portion 14 of the locking member 12 is located at the first end 6 of the second leg 5. According to the illustrated embodiment, a protrusion (bolt) is formed at the first end 6 of the first leg 4, which, as the first portion 13, engages with an opening (hole) at the first end 6 of the second leg 5, forming the second portion 14 of the locking member 12.

[0044] Figure 1 The device 1 of the present invention also includes an upright plate 15 on the distal end 16 of the device 1, which is located within the area of ​​the cylindrical container 10 in the second working state. Therefore, in the sense of the present invention, the distal end refers to the side of the device 1 facing away from the premature infant and newborn 3, while the proximal end refers to the side of the device 1 facing the premature infant and newborn 3.

[0045] In the second working state, the upright plate 15 is located within the area of ​​the cylindrical container 10, or in the first working state, it is located within the semi-cylindrical groove 7. According to... Figure 1 In the first embodiment shown, the upright plate is formed of two parts, with one upright plate portion 18 disposed on the respective first and second supports 4 and 5. In the second operating state of the device 1, the two upright plate portions 18 of the upright plate 15 are arranged adjacent to each other.

[0046] A semi-circular member 20 is disposed at the distal end 19 of the corresponding upright plate portion 18 of the upright plate 15. The semi-circular member 20 is axially aligned with the semi-cylindrical grooves 7 of the first and second legs 4, 5. In the second operating state, the two semi-circular members 20 form a circular container 21 to secure the umbilical cord 11 of the premature infant and newborn 3. In the second operating state, the circular container 21 is axially aligned with and spaced apart from the cylindrical container 10 to leave a cutting channel between the cylindrical container 10 and the circular container 21.

[0047] Preferably, the upright plate 15 or each upright plate portion 18 is connected to the first and / or second leg 4 of the device 1 via a predetermined break edge 22. In this way, the upright plate 15 can be quickly and easily removed from the device 1 by means of a buckle, so as not to obstruct the insertion of the umbilical catheter 2 into the blood vessels of the umbilical cord 11.

[0048] Advantageously, the semi-cylindrical groove 7 in the first operating state and the cylindrical container 10 in the second operating state are both conical, with the cone gradually widening from the proximal end 17 to the distal end 16 of the device 1. As a result, the umbilical cord 11 is particularly well secured in the device 1 of the invention. In particular, the blood vessels of the umbilical cord 11 can be compressed in such a way that no blood escapes after cutting, but the umbilical cord conduit 2 can be inserted into the blood vessels of the umbilical cord 11 at the same time.

[0049] To further improve the fixation of the umbilical cord 11 in the cylindrical container 10 of the device 1 during the second working state, the semi-cylindrical groove 7 or the cylindrical container 10 is provided with perforations for forming the thin plate layer 23.

[0050] In addition, the first leg 4 and the second leg 5 each have outwardly extending wing plates 24 on their distal ends 16, which serve as finger guards.

[0051] In particular, from Figure 2 It can be seen that spring element 9 is circular and is open in the first working state. From Figure 3 It can be seen that the circular spring 9 is closed in the second working state.

[0052] The preferred device 1 is integrally formed and preferably made of plastic. In this way, the manufacture of the device is cost-effective, and therefore, in particular, device 1 can be provided as a disposable product.

[0053] Figures 3-5 The illustration shows the device 1 of the present invention used to place an umbilical cord catheter 2 in a premature infant or newborn 3. In the first operating state of the device 1, the umbilical cord 11 of the premature infant 3 or newborn 3 is located between the first leg 4 and the second leg 5 within the two semi-cylindrical grooves 7. The user then moves the first leg 4 and the second leg 5 of the device 1 closer together, thereby switching the device 1 to the second operating state. Once the first and second legs 4, 5 are close together, the device 1 is secured in this second operating state by the locking member 12. Figure 3 This second working state is shown.

[0054] For this purpose, the scalpel 25 is guided along the distal end of device 1, with the distal edge of device 1 acting as a guide. The umbilical cord 11 is secured in place by the circular container 21 and the cylindrical container 10. The umbilical cord 11 is cut against the upright plate 15.

[0055] Subsequently, the upright plate 15 was bent, making the severed umbilical cord 11, especially its blood vessels, clearly visible and accessible. This situation is as follows... Figure 4 As shown. The umbilical cord catheter 2 can now be quickly and easily inserted into the intended vessel of the umbilical cord 11.

[0056] like Figure 5 As shown, after the umbilical cord catheter 2 is placed, the device 1 is removed by disengaging the locking component 12. To prevent blood leakage from the non-inserted vessels of the umbilical cord, the latter is ligated. Care should be taken to ensure that the placed umbilical cord catheter 2 remains in the open position.

[0057] Figure Label Definitions

[0058] 1 device 15 upright plates

[0059] 2. Umbilical cord catheter, 16. Distal end (device)

[0060] 3. Premature infants and newborns 17. Proximal (device)

[0061] 4. First leg, 18 upright board section

[0062] 5. Second leg, 19. Distal end (upright board)

[0063] 6. First end 20 semi-circular component

[0064] 7 Semi-cylindrical grooves 21 Circular containers

[0065] 8 Second end 22 Predetermined fracture edge

[0066] 9 spring components 23 thin plate layers

[0067] 10 cylindrical containers, 24 wing plates (finger guards)

[0068] 11 umbilical cord 25 scalpel

[0069] 12 locking components

[0070] 13 Locking Components, Part 1

[0071] 14 Locking Components Part 2

Claims

1. A device (1) for assisting in the placement of an umbilical cord catheter (2) in premature infants and newborns (3), comprising: First leg (4) and second leg (5), The first and second legs (4, 5) each include a semi-cylindrical groove (7) in the region of the first end (6) and are connected to each other by a spring member (9) in the region of the second end (8). The feature is that, under the action of spring force, the spring member (9) keeps the first and second legs (4,5) in a first working state, in which the first ends (6) of the first and second legs (4,5) are separated from each other. And wherein the first and second legs (4, 5) are able to overcome spring resistance and rotate to a second working state, in which the first ends (6) of the first and second legs (4, 5) are arranged close to each other. The semi-cylindrical grooves (7) in the respective first end (6) regions of the first and second legs (4,5) together form a cylindrical container (10) for placing the umbilical cord (11) of the premature infant and newborn (3) in the second working state.

2. The apparatus (1) according to claim 1, characterized in that, It further includes a locking component (12) for locking the device (1) in the second operating state.

3. The device (1) according to claim 2, characterized in that: The locking component (12) is designed to be removable or non-removable.

4. The apparatus (1) according to claim 3, characterized in that: The locking component (12) is a simple interlocking connection mechanism.

5. The apparatus (1) according to claim 2, characterized in that, The locking component (12) is formed at the first end (6) of the first and second legs (4, 5).

6. The apparatus (1) according to claim 5, characterized in that: The first part (13) of the locking member (12) is formed at the first end (6) of the first leg (4), and the second part (14) of the locking member (12) is formed at the first end (6) of the second leg (5).

7. The apparatus (1) according to claim 1, characterized in that: It further includes an upright plate (15) located on the distal end (16) of the device (1) within the region of the cylindrical container (10) in the second operating state.

8. The apparatus (1) according to claim 7, characterized in that, The upright plate (15) includes two upright plate portions (18), which are respectively disposed on each of the first and second legs (4,5). In the second working state, the two upright plate portions (18) are adjacent to each other.

9. The apparatus (1) according to claim 8, characterized in that, A semi-circular member (20) is provided at the distal end (19) of the upright plate portion (18) of the upright plate (15), which is axially aligned with the semi-cylindrical groove (7) of the first and second legs (4,5). The two semi-circular members (20) form a circular container (21) in the second working state to fix the umbilical cord (11) of the premature infant and newborn (3). The circular container (21) is axially aligned with and spaced apart from the cylindrical container (10) in the second working state, thereby leaving a cutting channel between the cylindrical container (10) and the circular container (21).

10. The apparatus (1) according to claim 8, characterized in that, Each upright plate section (18) is connected to the first and / or second legs (4,5) of the device (1) via a predetermined fracture edge (22).

11. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The semi-cylindrical groove (7) is conical in the first working state, and the cylindrical container (10) is conical in the second working state. The cone gradually widens from the proximal end (17) of the device (1) to the distal end (16) of the device (1).

12. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The semi-cylindrical groove (7) in the first working state and the cylindrical container (10) in the second working state have grooves inside.

13. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The semi-cylindrical groove (7) in the first working state and the cylindrical container (10) in the second working state have openings forming a thin plate layer (23) inside.

14. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The first and second legs (4, 5) each have a wing plate (24) extending outward on the distal end (16) of the device (1) for finger guards.

15. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The spring (9) is circular and is open in the first working state and closed in the second working state.

16. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The device (1) is formed as a whole.

17. The apparatus (1) according to any one of claims 1 to 10, characterized in that, The device (1) is made of plastic material.

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