Device for assisting in the placement of umbilical catheters in premature infants and neonates - Patents.com

Abstract

The present invention relates to a device (1) for assisting the placement of an umbilical catheter (2) in premature and newborn infants (3). The device (1) comprises a first leg (4) and a second leg (5), each of which comprises a semi-cylindrical recess (7) in the region of a first end (6) and which are connected to one another in the region of a second end (8) via a spring element (9). The spring element (9) holds the first leg (4) and the second leg (5) by means of a spring force in a first operating state in which the first ends (6) of the first leg (4) and the second leg (5) are spaced apart from one another, and the first leg (4) and the second leg (5) are transferable against the spring force to a second operating state in which the first ends (6) of the first leg (4) and the second leg (5) are arranged directly adjacent to one another. The semi-cylindrical recesses (7) in the region of the first ends (6) of the first (4) and second (5) legs together form a cylindrical receptacle (10) for the umbilical cords (11) of the premature and newborn babies (3) in the second operating state.

Description

[Technical field]

[0001] The present invention relates to a device for assisting in the placement of an umbilical catheter in premature infants and neonates, particularly into the umbilical cord vessels of premature infants and neonates. [Background technology]

[0002] During the initial treatment of a premature or newborn infant, vascular access may be required (immediately) to administer medications or fluids to the premature or newborn infant. Of particular importance is that the initial treatment of premature and newborn infants in the context of resuscitation must be particularly rapid and safe.

[0003] In the state of the art, three different methods of vascular access are known and routinely used: umbilical catheter, peripheral venous access and intraossaere Zugangio access. All accesses are placed by experienced personnel. This requires a lot of practice and experience on the part of medical personnel. Especially in the case of the first alternative, it is hectic with several people placing the vascular access at the same time. This often leads to spatial problems around premature and newborn babies.

[0004] Rapid placement of peripheral venous catheters (PVK) is performed by specially trained and experienced personnel. However, this placement is not always successful and becomes more difficult the more immature or stressed the infant or newborn is. Especially during resuscitation, the insertion of the catheter is often particularly difficult. Possible puncture sites are the back of the hand, the back of the foot, the veins of the head and the cubital veins. Especially in very small premature infants, as well as in premature infants and newborns with a poor circulatory state, placement of peripheral venous access is usually not possible.

[0005] As an alternative access, an io approach can be performed via the proximal tibia. However, the io approach is only acceptable from a body weight of 3000 grams and carries additional risks such as bone injury, inflammation and growth disorders of the lower limb bones. However, it is now technically easier to insert an io access than an umbilical catheter and is therefore often much faster.

[0006] Another alternative access is an umbilical catheter. In this case, a blood vessel in the umbilical cord is catheterized or cannulated. The blood vessel can be the umbilical vein or umbilical artery. Venous or arterial access in critically ill premature infants and newborns in the first few minutes of life is essential to administer emergency medications such as volume boluses, glucose, and Suprarenin. Failure to do so increases the likelihood of sequelae of hypotension, hypoglycemia, or persistent bradycardia.

[0007] The main problem when placing umbilical vein catheters (Nabelvenenkatheters, NVK) or umbilical artery catheters (Nabelarterienkatheters, NAK) is to find the vessel and prepare it so that the vessel lumen is visible. With the current state of the art, this is solved, for example, by manually dilating the umbilicus using two surgical forceps. This requires at least one other person to present the umbilicus so that the other person can place the catheter.

[0008] Thus, placing an umbilical catheter has two major drawbacks. First, it requires at least two experienced physicians working together to place the catheter, both of whom are actively working on the umbilicus, which can create spatial problems around premature and newborn infants. Second, it requires a lot of experience from those physicians, which usually proves very difficult or frustrating from a craftsmanship perspective to place the catheter.

[0009] To overcome these two drawbacks, US Pat. No. 6,399,633 discloses a medical device for placing a catheter in the umbilical vessels of a premature infant, the medical device having a longitudinal axis, a proximal end, and a distal end. The proposed device is configured as a sheath that surrounds a portion of the umbilical cord. The medical device includes a clamping device for clamping the umbilical cord, a cutting device for cutting the umbilical cord to form an umbilical interface, and a hooking device for expanding the umbilical interface. The medical device clamps the umbilical cord, separates the umbilical cord, and expands the umbilical cord for the placement of an umbilical catheter. However, a drawback of this medical device is its complex structure and its associated manufacturing costs. Although the medical device is reusable, it must be disinfected after each use, which is costly, especially since a large number of moving elements are involved. Another drawback is that the location and anatomical shape of the umbilical vessels vary greatly, which can make it difficult to implement the solution described in the patent. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2018 / 202844 Summary of the Invention [Problem to be solved by the invention]

[0011] It is therefore an object of the present invention to disclose a new medical device for placing a catheter in an umbilical vessel, which simplifies the difficult insertion of a catheter through the umbilical vessel and avoids the drawbacks of medical devices known in the prior art. [Means for solving the problem]

[0012] According to the present invention, this problem is solved by a device for assisting the placement of an umbilical catheter in premature infants and newborns, comprising: A first leg and a second leg, the first leg and the second leg each have a semi-cylindrical recess in the region of the first end and are connected to each other in the region of the second end via a spring element, the spring element holds the first leg and the second leg by a spring force in a first operating state in which the first ends of the first leg and the second leg are spaced apart from each other, and the first leg and the second leg are movable against the spring force to a second operating state in which the first ends of the first leg and the second leg are disposed directly adjacent to each other; The semi-cylindrical recesses in the region of the respective first ends of the first and second legs together form a cylindrical receptacle for the umbilical cord of the premature baby and the newborn baby in the second operating state.

[0013] The device according to the invention has a particularly simple design, since only two movable legs are connected to each other via spring elements. The umbilical cord is fixed in the cylindrical receptacle in the second operating state. The distal edges of the first and second legs, which are adjacent to each other in the second operating state, serve as a guide for a scalpel in order to cut the umbilical cord at the distal edge of the device according to the invention. In this way, a particularly straight cutting edge is achieved, and it has been found that with such a cutting edge it is possible to avoid dilating the umbilical cord, which is required in the prior art, since the blood vessels in the umbilical cord can be clearly seen and a catheter can also be inserted without problems.

[0014] The device according to the invention allows an umbilical catheter to be easily and quickly inserted into the vessels of the umbilical cord of premature and newborn babies. For this purpose, the umbilical cord is arranged between the first and second legs of the device in the first operating state, such that when the device is compressed and thereby transferred to the second operating state, the umbilical cord is arranged in a receptacle at the first end of the first and second legs. Once the umbilical cord is fixed in the cylindrical receptacle formed in the second operating state, it can be cut with a scalpel, which is guided along the distal edge of the device according to the invention, thereby obtaining a clean cut. The catheter can then be inserted into the desired vessels of the umbilical cord of premature and newborn babies. When the device is now released, it automatically goes into the first operating state in which the first and second legs unfold and the umbilical cord is released. To prevent blood from leaking out of vessels in which the catheter is not inserted, the umbilical cord can be tied off. This simultaneously fixes the catheter in the clamped vessel so that it cannot be displaced any further.

[0015] The device according to the invention has a particularly simple design, in particular does not have any moving parts such as pivoting knives or hooks. As a result, the device according to the invention can be sterilized very easily. Alternatively, however, the device according to the invention can also be produced without difficulty as a disposable product and disposed of after use, since its simple structure allows for cheap production. Thus, the disadvantages of the prior art are avoided.

[0016] In an advantageous variant of the invention, the device comprises a locking device for locking the device in the second operating state. This means that the user of the device does not have to hold the device in the second operating state against a spring force, as the device is locked in this second operating state. The user can thus fully concentrate on cutting the umbilical cord and placing the umbilical catheter. Preferably, the locking device locks automatically when the user transfers the device to the second operating state.

[0017] According to a preferred variant of the invention, the locking device is designed to be detachable, in particular as a latch connection, in order to make it possible to remove the device again after the umbilical catheter has been placed. For this purpose, for example, the latch connection is released by moving the latch.

[0018] According to a variant according to the invention, the locking device is formed at the first ends of the first and second legs, in particular a first part of the locking device is formed at the first end of the first leg and a second part of the locking device is formed at the first end of the second leg. In particular, the first and second legs are therefore firmly fixed relative to each other by the locking device, precisely in the area where a cylindrical receptacle for the umbilicus is formed in the second operating state. The umbilicus is therefore firmly fixed in the receptacle, since the first and second legs cannot move due to the locking device. For example, the first end of the first leg has an eyelet and the first end of the second leg has a detent (protrusion) which engages in the eyelet in the second operating state.

[0019] In a particularly preferred variant of the invention, the device, in the second operating state, comprises a ridge on the distal side of the device in the region of the cylindrical receptacle of the umbilical cord, which ridge acts as a cutting edge (counter-bearing) when cutting the umbilical cord. The umbilical cord is cut by a scalpel guided along the distal edge of the device. The ridge is arranged behind the umbilical cord in the cutting direction, so that the umbilical cord is supported by the ridge during cutting, making the cutting easier.

[0020] According to a preferred variant of the invention, the ridge is divided into two parts, one part of the ridge being arranged on each of the first and second legs. In the second operating state, the two parts of the ridge are arranged directly adjacent to each other. Typically, for safety reasons, the cut is always directed away from the user's body. In this case, it means that the cut for slicing open the umbilical cord is made towards the first end of the device. The ridge must therefore be arranged at the first end of the device, preferably in the cutting direction, behind the cylindrical receptacle for the umbilical cord. 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 received in the device. For this reason, it is expedient for each leg to have a part of the ridge, which together form the ridge in the second operating state.

[0021] In an advantageous variant of the invention, a semicircular element is arranged at the distal end of the respective portion of the protuberance, the semicircular element being axially aligned with the semicylindrical recesses of the respective first and second legs, the two semicircular elements forming a circular receptacle in the second operating state for fixing the umbilical cord of the premature baby and the newborn, the circular receptacle being axially aligned with the cylindrical receptacle in the second operating state and spaced apart from the cylindrical receptacle so as to leave a cutting channel between them. As a result, the umbilical cord of the premature baby is fixed both below the cutting channel by the cylindrical receptacle and above the incision channel by the circular receptacle. This makes it particularly easy to cut the umbilical cord.

[0022] According to one variant according to the invention, the ridge or a part of the ridge is connected to at least one of the first and second legs of the device via a predetermined breaking edge. The ridge can therefore be easily separated from the device after the umbilical cord is cut by simply unsnapping it. This prevents the ridge or a part connected to it, such as a semicircular element, from interfering with the insertion of the catheter into the blood vessels of the umbilical cord.

[0023] According to a further variant of the invention, the shape of the semi-cylindrical recess in the first operating state and the cylindrical receptacle in the second operating state is conical, the cone widening from the proximal side to the distal side of the device. As a result, the umbilical cord is fixed particularly well in the cylindrical receptacle. Furthermore, this allows, for example, the blood vessels in the umbilical cord to be squeezed in the proximal region, i.e. the narrower region of the cone, so that no or only very little blood flows out of the umbilical cord vessels after cutting. The cone should be designed so that the catheter can be inserted deep enough into the umbilical cord vessels to provide access to the vascular system of premature and newborn babies.

[0024] According to a variant according to the invention, the semi-cylindrical recess in the first operating state and the cylindrical receptacle in the second operating state are grooved on the inside and in particular have openings for forming lamellae, which further improves the fixation of the umbilical cord in the cylindrical receptacle.

[0025] In one variation according to the invention, the first and second legs each have distally outwardly extending wings as finger guards that protect the fingers of a user of the device from being cut when cutting the umbilical cord.

[0026] According to an advantageous variant of the invention, the spring element is circular and in a first operating state is open and in a second operating state is closed. In this way, the spring element can be easily manufactured and integrated into the device. Due to the diameter of the circular spring element, the spring force can be pre-adjusted.

[0027] According to an advantageous variant, the device according to the invention is formed in one piece. A one-piece device has the advantage that it can be easily disinfected. In particular, such a simple one-piece device can be produced cheaply, whereby preferably such a device is designed as a disposable product, since producing it is cheaper than disinfecting the device.

[0028] Preferably, the device according to the invention is made of plastic. For better handling, the first leg and the second leg may have gripping surfaces that are, for example, grooved, which improves the grip.

[0029] Preferably, the device according to the invention is manufactured and stored in multiples with different cylindrical receptacle diameters in the second operating state, so that in an emergency, one device with a suitable diameter for the current umbilical cord can be quickly selected, for example, the cylindrical receptacle has a diameter of 5 mm to 15 mm, in particular 7 mm, 9 mm or 11 mm, in the second operating state. [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 is a perspective view of one embodiment of a device according to the present invention for assisting in the placement of an umbilical catheter in premature infants and newborns in a first operating state. [Diagram 2] FIG. 2 is a top view of the device of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of one embodiment of a device according to the present invention in a second operating state, with the umbilical cord clamped before cutting. [Figure 4] FIG. 4 is a perspective view of the device of FIG. 3 after the umbilical cord has been cut and the protuberance has been removed. [Diagram 5] FIG. 13 shows an umbilical catheter in place after removal of the device according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] The invention is explained in more detail below with reference to example embodiments shown in the following drawings, in which: Figure 1 shows a perspective view of one embodiment of a device 1 according to the invention for assisting the placement of an umbilical catheter 2 in premature infants and newborns 3. Figure 2 shows a top view of the device 1 of Figure 1. The device 1 comprises a first leg 4 and a second leg 5. The first leg 4 and the second leg 5 each have a semi-cylindrical recess 7 in the region of a first end 6. In the region of a second end 8 the first leg 4 and the second leg 5 are connected to each other via a spring element 9.

[0032] The spring element 9 holds the first leg 4 and the second leg 5 by an inherent spring force in a first operating state in which the first ends 6 of the first leg 4 and the second leg 5 are spaced apart. Figure 1 shows the device 1 in the first operating state.

[0033] The first leg 4 and the second leg 5 can be brought into a second operating state in which the first ends 6 of the first leg 4 and the second leg 5 are arranged directly adjacent to each other against a spring force. Figures 3 and 4 show, for example, the device 1 according to the invention in the second operating state.

[0034] According to a first embodiment of FIG. 1, the device 1 comprises a locking device 12 for locking the device 1 in a second operating state. In the first embodiment, the locking device 12 is designed as a releasable latch connection. The locking device, designed as a snap-in connection, is arranged at the first end 6 of the first leg 4 and at the first end 6 of the second leg 5, with a first part 13 of the locking device 12 arranged at the first end 6 of the first leg 4 and a second part 14 of the locking device 12 arranged at the first end 6 of the second leg 5. According to the illustrated embodiment, a projection (latch) is formed as the first part 13 at the first end 6 of the first leg 4, which can engage in an opening (eyelet) at the first end 6 of the second leg 5, which forms the second part 14 of the locking device 12.

[0035] The device 1 according to the invention in Fig. 1 further comprises, in the second operating state, a ridge 15 on the distal side 16 of the device 1 in the region of the cylindrical receptacle 10. The distal side in the sense of the invention is therefore the side of the device 1 facing away from the premature baby and newborn 3, and the proximal side is the side of the device 1 facing towards the premature baby and newborn 3.

[0036] The bump 15 is arranged in the region of the cylindrical receptacle 10 in the second operating state or in the region of the semi-cylindrical recess 7 in the first operating state. According to a first embodiment shown in Fig. 1, the bump is formed in two parts, one part 18 of the bump being arranged on each of the first leg 4 and the second leg 5. In the second operating state of the device 1, the two parts 18 of the bump 15 are arranged directly adjacent to each other.

[0037] The semicircular elements 20 are disposed at the distal ends 19 of the respective portions 18 of the ridges 15. The semicircular elements 20 are axially aligned with the semi-cylindrical recesses 7 of the respective first and second legs 4 and 5. In the second operating state, the two semicircular elements 20 form a circular receptacle 21 for securing the umbilical cord 11 of the premature and newborn infants 3. In the second operating state, the circular receptacle 21 is axially aligned with and spaced apart from the cylindrical receptacle 10 so as to leave a cutting channel between the cylindrical receptacle 10 and the circular receptacle 21.

[0038] Preferably, ridge 15 or ridge portion 18 is connected to at least one of first leg 4 and second leg 5 of device 1 via a predetermined breakaway edge 22. This allows ridge 15 to be quickly and easily detached from device 1 by buckling so as not to interfere with insertion of umbilical catheter 2 into the blood vessel of umbilical cord 11.

[0039] Advantageously, the shape of the semi-cylindrical recess 7 in the first operating state and the cylindrical receptacle 10 in the second operating state is conical, which cone widens from the proximal side 17 towards the distal side 16 of the device 1. As a result, the umbilical cord 11 is fixed particularly well in the device 1 according to the invention. In particular, the blood vessels of the umbilical cord 11 can be squeezed so that no blood flows out after cutting, while at the same time the umbilical catheter 2 can be inserted into the blood vessels of the umbilical cord 11.

[0040] To further improve the fixation of the umbilical cord 11 in the cylindrical receptacle 10 of the device 1 in the second operating state, the semi-cylindrical recess 7 or the cylindrical receptacle 10 has perforations for forming lamellae 23 .

[0041] Additionally, first leg 4 and second leg 5 each have outwardly extending wings 24 on distal side 16 as finger guards. As can be seen in particular from figure 2, the spring element 9 is circular and in a first operating state is open, while in a second operating state the circular spring element 9 is closed, as can be seen from figure 3.

[0042] The device 1 is preferably formed in one piece, preferably made from plastic, which allows for cost-effective manufacture, whereby the device 1 can in particular be provided as a disposable product.

[0043] Figures 3 to 5 show the use of the device 1 according to the invention for placing an umbilical catheter 2 in a premature baby or newborn 3. In a first operating state of the device 1, the umbilical cord 11 of the premature baby or newborn 3 is placed between the first leg 4 and the second leg 5 in the area of ​​the two semi-cylindrical recesses 7. The device 1 is then transferred to a second operating state by the user moving the first leg 4 and the second leg 5 of the device 1 towards each other. When the first leg 4 and the second leg 5 are directly adjacent to each other, the device 1 is fixed in this second operating state by the locking device 12. Figure 3 shows this second operating state.

[0044] The user can now cut the umbilical cord 11. To perform the cut, a scalpel 25 is guided along the distal side of the device 1, the distal edge of which acts as a guide. The umbilical cord 11 is fixed in place by the circular receptacle 21 and the cylindrical receptacle 10. The umbilical cord 11 is cut against the ridge 15.

[0045] The ridge 15 is then bent so that the severed umbilical cord 11, and in particular its blood vessels, are clearly visible and accessible. This situation is shown diagrammatically in Figure 4. The umbilical catheter 2 can now be quickly and easily inserted into the desired blood vessels of the umbilical cord 11.

[0046] After the umbilical catheter 2 has been placed, the device 1 is removed by releasing the locking device 12, as shown in Figure 5. The umbilical cord is tied off to prevent leakage of blood from vessels in which the umbilical catheter is not inserted. Care should be taken to ensure that the umbilical catheter 2 remains open once placed. [Explanation of symbols]

[0047] 1 Device 2. Umbilical catheter 3. Premature infants and newborns 4. First leg 5. Second leg 6 First End 7 Semi-cylindrical recess 8 Second End 9 Spring Elements 10 Cylindrical receptacle 11 Umbilical Cord 12 Locking Device 13 First part of the locking device 14 Second part of the locking device 15 prominence 16 Distal (device) 17 Proximal side (device) 18 Protuberance 19 Distal end (ridge) 20 Semicircular Elements 21 Circular Receptacle 22 Predetermined breaking edge 23 Lamella 24 Wing (Finger Guard) 25 Female

Claims

1. A device (1) for assisting in the placement of an umbilical catheter (2) in premature and neonatal infants (3), comprising: A first leg (4) and a second leg (5), said first leg (4) and said second leg (5) each have a semi-cylindrical recess (7) in the region of their first end (6) and are connected to one another in the region of their second end (8) via a spring element (9); the spring element (9) holds the first leg (4) and the second leg (5) by a spring force in a first operating state in which the first ends (6) of the first leg (4) and the second leg (5) are spaced apart from each other, and the first leg (4) and the second leg (5) can be transferred against the spring force to a second operating state in which the first ends (6) of the first leg (4) and the second leg (5) are arranged directly adjacent to each other, The device (1), wherein the semi-cylindrical recesses (7) in the region of the first end (6) of each of the first leg (4) and the second leg (5) together form a cylindrical receptacle (10) for the umbilical cord (11) of the premature and newborn infants (3) in the second operating state.

2. The device (1) according to claim 1 further comprises A device (1) comprising a locking device (12) for locking said device (1) in said second operating state.

3. A device (1) according to claim 2, The locking device (12) is designed releasably or non-releasably, in particular as a snap-in connection, of the device (1).

4. A device (1) according to claim 2 or claim 3, The device (1), wherein the locking device (12) is formed at the first end (6) of the first leg (4) and the second leg (5), in particular a first portion (13) of the locking device (12) is formed at the first end (6) of the first leg (4) and a second portion (14) of the locking device (12) is formed at the first end (6) of the second leg (5).

5. The device (1) according to any one of claims 1 to 4 further comprises: A device (1) comprising a ridge (15) on a distal side (16) of said device (1) in said region of said cylindrical receptacle (10) in said second operating state.

6. A device (1) according to claim 5, The device (1), wherein the ridge (15) is divided into two parts, one part (18) of the ridge being arranged on each of the first leg (4) and the second leg (5), and the two parts (18) of the ridge being directly adjacent to each other in the second operating state.

7. A device (1) according to claim 6, a semicircular element (20) is disposed at a distal end (19) of each portion (18) of the protuberance (15), the semicircular element (20) being axially aligned with a semi-cylindrical recess (7) of each of the first leg (4) and the second leg (5), the two semicircular elements (20) forming a circular receptacle (21) in the second operating state for fixing the umbilical cord (11) of the premature infant and the newborn infant (3), the circular receptacle (21) being axially aligned with and spaced apart from the cylindrical receptacle (10) in the second operating state so as to leave a cutting channel between the cylindrical receptacle (10) and the circular receptacle (21).

8. A device (1) according to any one of claims 5 to 7, The device (1), wherein the ridge (15) or the ridge (18) is connected to at least one of the first leg (4) and the second leg (5) of the device (1) via a predetermined breaking edge (22).

9. A device (1) according to any one of the preceding claims, The device (1), wherein the semi-cylindrical recess (7) in the first operating state is conical and the cylindrical receptacle (10) in the second operating state is conical, the conical shape widening from the proximal side (17) towards the distal side (16) of the device (1).

10. A device (1) according to any one of the preceding claims, The device (1), wherein the semi-cylindrical recess (7) in the first operating state and the cylindrical receptacle (10) in the second operating state are grooved on the inside and have openings, in particular for forming lamellae (23).

11. A device (1) according to any one of the preceding claims, The device (1), wherein each of the first leg (4) and the second leg (5) has an outwardly extending wing (24) on a distal side (16) thereof as a finger guard.

12. A device (1) according to any one of the preceding claims, The device (1), wherein the spring element (9) is circular and is open in the first operating state and closed in the second operating state.

13. A device (1) according to any one of the preceding claims, The device (1) is formed in one piece.

14. A device (1) according to any one of the preceding claims, The device (1) is made of a plastic material.

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