阅读说明：本技术 具有集成管心针的饲管 (Feeding tube with integrated stylet ) 是由 哈罗德·尼格 于 2020-05-05 设计创作，主要内容包括：本发明提供一种用于早产儿的微创表面活性物质治疗(LIST)手术的具有集成管心针的饲管,所述具有集成管心针的饲管具有柔性饲管,所述柔性饲管具有远端和近端以及在所述近端处的适配器。具有远端和近端的管心针定位在所述饲管内,并且在所述近端处具有锚固件。所述锚固件被构造成安置在所述适配器内以防止所述锚固件进入所述饲管,并且具有延伸穿过所述锚固件的一个或多个通道,以允许流体从所述适配器流动穿过所述通道并且穿过所述饲管,而所述锚固件保持安置在所述适配器内。(The present invention provides a feeding tube with an integrated stylet for minimally invasive surfactant therapy (LIST) procedures for premature infants, the feeding tube with an integrated stylet having a flexible feeding tube with a distal end and a proximal end and an adapter at the proximal end. A stylet having a distal end and a proximal end is positioned within the feeding tube and has an anchor at the proximal end. The anchor is configured to be positioned within the adapter to prevent the anchor from entering the feeding tube, and has one or more passages extending through the anchor to allow fluid to flow from the adapter through the passages and through the feeding tube while the anchor remains positioned within the adapter.)

1. A feeding tube with an integrated stylet, comprising: a flexible feeding tube having a distal end and a proximal end, the flexible feeding tube having an adapter at the proximal end; and a stylet having a distal end and a proximal end, the stylet positioned within the feeding tube and having an anchor at the proximal end, wherein the anchor is configured to be disposed within the adapter to prevent the anchor from entering the feeding tube, and wherein the anchor has one or more channels extending therethrough to allow fluid to flow from the adapter through the channels and through the feeding tube while the anchor remains disposed within the adapter.

2. The feeding tube with integrated stylet of claim 1, wherein the anchor has opposing proximal and distal sides and a peripheral edge therebetween, and wherein the one or more channels extend between the proximal and distal sides.

3. The feeding tube with integrated stylet of claim 2, wherein the one or more channels are spaced apart from the peripheral edge.

4. The feeding tube with integrated stylet of claim 3, wherein the distal side of the anchor is attached to the proximal end of the stylet and has a recess formed thereon in fluid communication with the one or more channels.

5. The feeding tube with integrated stylet of claim 4, wherein the feeding tube has an inner diameter and the stylet has an outer diameter that is smaller than the inner diameter of the feeding tube, thereby providing an annular space in the feeding tube around the stylet.

6. The feeding tube with integrated stylet of claim 5, wherein the adapter has an inlet port extending from a proximal end of the feeding tube and defining a shoulder shaped complementary to the anchor to engage with and prevent entry into the feeding tube.

7. The feeding tube with integrated stylet of claim 6, wherein the anchor is generally disc-shaped and the shoulder is generally ring-shaped.

Technical Field

The present invention relates to feeding tubes for tracheal insertion, and more particularly to a stylet-reinforced feeding tube for intratracheal instillation of pulmonary surfactant in premature infants suffering from Neonatal Respiratory Distress Syndrome (NRDS).

Background

Neonatal Respiratory Distress Syndrome (NRDS) is a respiratory condition affecting premature infants, which is treated by insertion of a small diameter catheter into the trachea for intratracheal instillation of a pulmonary surfactant, while the infant is breathing spontaneously under Continuous Positive Airway Pressure (CPAP) support. Instillation of surfactant to spontaneously breathing preterm infants is likely to improve respiratory management. However, even for experienced physicians, endotracheal intubation is considered a difficult procedure.

Recently, low-invasive or minimally invasive surfactant therapy (LIST) technology has been developed, which is associated with a number of positive outcomes, including reduction: early CPAP failure, invasive ventilation requirements, bronchopulmonary dysplasia (BPD), and death or a combined outcome of BPD.

It has been shown that catheters used by physicians in performing LIST procedures affect their effectiveness (see Rigo et al devices for less invasive surface active agent acta Paediatrica 2017; 106: 1091-.

However, when using a stylet to reinforce a feeding tube for insertion into the trachea, it is important to ensure that the stylet does not extend beyond the end of the feeding tube, as this may result in injury to the patient. To this end, many stylets have a handle or loop that extends out of the feeding tube adapter and prevents the end of the stylet from protruding from the distal end of the feeding tube. Therefore, the stylet must be removed from the feeding tube before attaching the syringe carrying the pulmonary surfactant to the feeding tube adapter for intratracheal instillation.

Accordingly, there is a need for a stylet-reinforced feeding tube for use in LIST procedures that prevents the stylet from protruding from the distal end of the feeding tube, but does not require removal of the stylet prior to performing an endotracheal instillation of a pulmonary surfactant.

Disclosure of Invention

In accordance with the present invention, a feeding tube with an integrated stylet has a flexible feeding tube with a distal end and a proximal end and an adapter at the proximal end. A stylet having a distal end and a proximal end is positioned within the feeding tube and has an anchor at the proximal end. The anchor is configured to be positioned within the adapter to prevent the anchor from entering the feeding tube, and has one or more passages extending through the anchor to allow fluid to flow from the adapter through the passages and through the feeding tube while the anchor remains positioned within the adapter.

Drawings

For a more clear understanding of the present invention, preferred embodiments thereof will now be described in detail, by way of example, with reference to the accompanying drawings, in which:

fig. 1 is a perspective view of a feeding tube with an integrated stylet according to the present invention, shown attached to a syringe.

Fig. 2 is a side view of the device shown in fig. 1.

Fig. 3 is a top view of the device of fig. 1.

Fig. 4 is a cross-sectional view of the device taken along line a-a in fig. 3.

Figure 5 is a detailed view of the proximal end of the feeding tube defined by area B in figure 4.

Figure 6 is an end view of the anchor of the stylet.

Fig. 7 is a cross-sectional view of the anchor taken along line C-C of fig. 6.

Detailed Description

In accordance with the present invention, a feeding tube with an integrated stylet prevents the tip of the stylet from protruding from the distal end of the feeding tube and allows the stylet to remain in place during surfactant delivery in LIST procedures.

As shown in fig. 1-3, the feeding tube 1 is a flexible tube having a distal end 1a and a proximal end 1b with an adapter 2 at its proximal end 1b for attachment to a syringe tip. The size of the feeding tube 1 may be determined as desired for a particular application. For example, a typical feeding tube 1 for LIST procedures is between 18cm and 23cm in length and has an inner diameter of less than 1 mm. Preferably, the feeding tube 1 has a length of 20.5cm and an internal diameter of 0.91 mm. As shown in FIG. 4, the adapter 2 has a root 3 attached to the proximal end 1b of the feeding tube 1 and an inlet 4 extending from the proximal end 1b of the feeding tube 1. The interior of the inlet port 4 is shaped to engage the anchor 6 (as described below) and prevent it from entering the feeding tube 1. Preferably, the interior of the inlet port 4 is shaped to form a shoulder 7 of approximately 90 adjacent the proximal end 1b of the feeding tube 1. Alternatively, the interior of the inlet port 4 may be tapered or otherwise shaped such that the inner diameter of the periphery or a portion of the periphery of the inlet port 4 adjacent the proximal end 1b of the feeding tube 1 is greater than the inner diameter of the feeding tube 1.

The stylet 5 is a semi-rigid length of wire having a distal end 5a and a proximal end 5b, with an anchor 6 at its proximal end 5b for placement in the adapter 2. The stylet 5 is sized to extend substantially the length of the feeding tube 1 for stiffening the feeding tube 1 during insertion into the trachea, but does not protrude from the distal end 1a of the feeding tube 1. By way of example, a typical stylet 5 is about 2cm, preferably about 18.5cm, shorter in length than the corresponding feeding tube 1, and between 0.48mm and 0.54mm, preferably 0.51mm in diameter. As shown in FIG. 5, the anchor member 6 is sized and shaped to be positioned in the adapter 2 adjacent the proximal end 1b of the feeding tube 1, but not into the proximal end 1b of the feeding tube 1. Preferably, the anchor 6 is substantially disc-shaped with a diameter greater than the stylet 5. By way of example, a typical anchor 6 has a diameter of between 3.15mm and 3.21mm, preferably 3.18mm, and a thickness. The anchor 6 seats against a shoulder 7 formed in the inlet 4 of the adapter 2 adjacent the proximal end 1b of the feeding tube 1.

In the case of a substantially disc-shaped anchor member 6, the shoulder portion 7 is substantially annular with a diameter slightly larger than that of the anchor member 6. Thus, the anchor 6 seats against a shoulder 7 in the adapter 2 and is prevented from entering the feeding tube 1. Alternatively, the anchor 6 may have a substantially spherical shape, which rests against a corresponding rounded shoulder 7. Similarly, the anchor 6 may be dome-shaped, with the rounded side being distal to the anchor 6, which is attached to the proximal end 5b of the stylet 5. Anchors 6 may have a variety of other shapes, including tapered anchors 6 or triangular, rectangular, pentagonal, hexagonal, etc. prismatic anchors 6. Regardless of the shape of the anchor 6, the shoulder 7 is shaped to complement the anchor 6 so that the anchor 6 seats against the shoulder within the adapter 2, preventing it from entering the feeding tube 1.

As shown in fig. 6 and 7, anchor 6 has one or more channels 8 extending through the thickness of anchor 6 to allow fluid, such as lung surfactant from a syringe, to pass through anchor 6. Thus, the stylet 5 provides increased stiffness to the feeding tube 1, which facilitates insertion into the trachea, while allowing the stylet 5 to remain in place during surfactant delivery. Preferably, as shown in fig. 7, the anchor 6 has two channels 8 on either side of the stylet 5, with a diameter between 0.45mm and 0.55mm, preferably 0.50 mm. Preferably, the anchor 6 also has an annular recess 9 formed around the stylet 5 on the side of the anchor 6 abutting the shoulder 7. The recess 9 facilitates the flow of fluid from the channel 8 into the annular space surrounding the stylet 5 in the feeding tube 1. The channel 8 opens into a recess 9 of sufficient depth to prevent the shoulder 7 from obstructing the flow of fluid through the channel 8. For example, the depth of the recess 9 may be between 0.45mm and 0.55mm, preferably 0.50 mm. In an exemplary embodiment, the anchor 6 has a diameter of 3.18mm, the stylet 5 has a length and diameter of 18.5cm and 0.51mm, respectively, and the channel 8 has a diameter and the recess 9 has a depth of 0.50 mm.

Preferably, the anchor 6 and stylet 5 can be removed from the feeding tube 1 by unseating the anchor 6 and removing it from the proximal end 1b of the adapter 1. Alternatively, the anchor 6 may be permanently attached or integrally formed with the feeding tube 1 or adapter 2.

In operation, a physician treating a premature infant with NRDS grasps the proximal end 1b of the feeding tube 1 and/or adapter 2. The stylet 5 provides rigidity to the feeding tube 1 to facilitate insertion of the distal end 1a of the feeding tube 1 into the trachea of a patient by a physician. The physician can then attach a syringe containing the lung surfactant to the inlet 4 of the adapter 2 and start intratracheal instillation. The lung surfactant is allowed to flow through the passage 8 in the anchor 6 and through the feeding tube 1. Thus, the present invention eliminates the step of first removing the stylet 5 from the feeding tube 1 before beginning intratracheal instillation.

Although the invention has been described with reference to its application in LIST procedures for treating premature infants with NRDS, it may be applied in other fields and other treatments requiring reinforcement using a stylet that allows fluid to flow through the feeding tube without removing the stylet.

While the invention has been described and illustrated with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention as set forth in the claims below. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed herein.