RU2847280C1 - Device for eliminating stressed pneumothorax - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: invention relates to device for eliminating stressed pneumothorax. The device for eliminating strained pneumothorax contains a catheter with a cannula, a metal stiletto needle and a bypass valve. From the distal end of the catheter, at a distance of 5 to 35 mm, two holes with a diameter of 1.0 to 4.0 mm are made on opposite sides. The internal lumen of the catheter ranges from 1.0 to 4.0 mm. At the proximal end of the catheter, there is a square-section handle and a flange for connecting a bypass valve. The handle has two holes with a diameter of 0.1 to 1.3 mm for fixing the catheter to the skin. A centering sleeve is fitted to the stiletto needle, in which two holes are made, one of which is designed for needle insertion, and the second for air outlet when the stiletto needle with a catheter penetrates the pleural cavity. A sleeve with a stiletto needle and a catheter is inserted into the inner part of the connecting body, from the opposite end of which there is a seat for storing the bypass valve. The connecting body is designed to hold a case to protect the needle-stiletto with a catheter and a cap to protect the bypass valve. The stiletto needle is designed to be extracted from the lumen of a catheter with a connecting body with a cap located at its end.

EFFECT: to increase the effectiveness of eliminating strained pneumothorax, reduce the risk of recurrence and complications, as well as increase the reliability of fixation and reduce the likelihood of thrombosis of the catheter lumen with blood in the treatment of strained pneumothorax.

4 cl, 3 dwg

Description

The invention relates to medical devices and is intended to eliminate tension pneumothorax resulting from chest injury: a gunshot wound or a wound caused by a sharp object; mechanical damage, and ensures the release (evacuation) of air from the pleural cavity, intended for use both at the stages of medical evacuation and in emergency medical care conditions.

Chest wounds and injuries are a common type of injury and a leading cause of death in the wounded in both peacetime and wartime. The high mortality rate of chest wounds is due to the frequent development of life-threatening complications from chest injuries, primarily tension and open pneumothorax [1, 2].

Tension pneumothorax most often develops following a chest wound or injury accompanied by massive damage to the lung parenchyma, a major bronchus, or trachea in the absence of a gaping chest wall wound, or in the case of an open chest wound or injury resulting in a valve-like lesion of the chest wall (valvular pneumothorax). Tension pneumothorax can also develop "under a dressing." This group of patients is characterized by pronounced signs of respiratory failure, manifested by a high respiratory rate (up to 30-50 breaths per minute), general cyanosis, decreased blood pressure, and an increased heart rate. Extensive subcutaneous and intermuscular emphysema develops (in some cases extending to the retrobulbar tissue of the eyes above and the genitals below) and tracheal deviation to the side opposite the injured side.

The results of a retrospective analysis of autopsy reports of 540 military personnel killed on the battlefield during the armed conflict in the Chechen Republic (1994-1996) showed that chest wounds with the development of tension pneumothorax were the second leading cause of death, reaching 19.0% in the group of potentially salvageable patients [3]. Tension pneumothorax is a severe life-threatening consequence of chest wounds with an incidence of up to 9.9% in those wounded in the chest. Timely elimination of tension pneumothorax at the prehospital stage leads to a twofold decrease in hospital mortality from 37.5 to 18.2% (p=0.028), respectively; a decrease in the incidence of complications from 72.7% to 33.3% (p=0.017).

Puncture and decompression of the pleural cavity at the pre-hospital stage allows for the elimination of tension pneumothorax and is a life-saving manipulation [4].

According to various sources, chest injuries in peacetime conditions account for 8-12.5%, 3.5-16%, and even 35-50% [5] of all mechanical injuries of various locations that result in hospitalization. A distinctive feature of chest injuries is their severity, caused by sudden hemodynamic and respiratory disturbances that pose a direct threat to life [6]. Mortality from chest injuries shows no sign of decreasing.

According to current algorithms for providing emergency and urgent medical care to patients and injured people, emergency medical teams must apply an occlusive dressing to open pneumothorax (circular dressings are prohibited). Tension pneumothorax must be converted to an open pneumothorax by pleural puncture in the second intercostal space along the midclavicular line or in the fourth intercostal space along the anterior axillary line [7]. However, domestic emergency medical services do not have the necessary equipment to perform these procedures.

Experience has shown that in cases of tension pneumothorax, performing vital puncture and drainage of the pleural cavity by paramedics at the pre-hospital stage allows for the effective elimination of tension pneumothorax [8].

Means for decompression of the pleural cavity in tension pneumothorax.

The Dufault needle, with a petal valve made of glove rubber (like a finger) with a slit at the end, is recommended for use in military field surgery guidelines. While simple to design and use, the device has relatively low reliability and effectiveness compared to modern medical devices, partly due to the insufficient needle length (45 mm). A significant advantage of this device is the development of a prototype one-way valve that prevents air from entering the pleural cavity. Despite this, the risk of postoperative complications remains significant due to the rigid material, the risk of injury from the needle in the pleural cavity, and the inability to securely attach the device to the patient's chest wall.

The device for draining the pleural cavity (Device for draining the pleural cavity: patent RU2113 247, Russian Federation, application RU95118598, filed 02.11.1995, published 20.06.1998), patented in 1998 by a team from the I.I. Dzhanelidze Research Institute of Emergency Care, is designed to ensure high reliability of drainage in chest trauma.

The device's tee, which has a single connection for inserting an endoscope, capillary drainage, and trocar, reduces the possibility of depressurization of the pleural cavity.

The use of elastic polymer materials reduces the risk of infectious complications, and the increased diameter of the drainage catheter's internal lumen improves its reliability. However, the device's bulky design and the difficulty of securing it to the patient's chest wall limit its use for effective pleural occlusion.

Also known is the ARS Decompression Needle [9], which is supplied to NATO troops and the US Army and is a catheter with a needle, enclosed in durable and easy-to-use packaging.

A significant advantage of the device is that the needle terminates not in a cap but in an open reservoir, allowing for rapid confirmation of the correct needle position and the effectiveness of pleural decompression. The polymer catheter reduces the risk of iatrogenic complications, and, combined with its rigid packaging, makes it convenient for use in combat situations. However, the device does not provide a means of securing the inserted catheter to the chest wall, and the small internal lumen often leads to obstruction due to blood clotting within the catheter lumen [10].

Also known is a device for eliminating pneumothorax [11], consisting of a needle with a spring-loaded mandrel and a valve, characterized in that it additionally contains a movable needle position lock located on a tubular body, and the valve is a membrane valve and is installed in a separate removable body.

Disadvantages of this device include the narrow catheter lumen, which increases the risk of obstruction by a blood clot, as well as possible ineffective air evacuation, necessitating the use of a second device. Furthermore, the metal catheter increases the risk of lung injury, which increases during transport. Furthermore, the device's locking mechanism does not provide secure fixation, which can lead to the needle being displaced deeper into the pleural cavity, causing lung injury. For more secure fixation, the needle locking mechanism must be folded back, which can lead to deformation and requires considerable force. Another disadvantage of this device is that the needle's dip indicator can become trapped (clamped) by foreign tissue in the needle channel during puncture. Furthermore, in the presence of pleural fluid or when administering medications through the catheter (needle), a significant amount of fluid may accumulate in the needle lumen. It is impossible to completely remove this fluid from the needle body using a syringe.

Also known is a device for treating pneumothorax [12], including a drainage tube having an outer part with a check valve installed in it, and an inner part with transverse holes in its wall, characterized in that the tube is provided with an occlusive dressing made of an airtight material with an adhesive base, wherein the outer diameter of the outer part of the drainage tube is larger than the outer diameter of the inner part, and the transition between the outer and inner parts has a conical shape, wherein the occlusive dressing is hermetically installed on the outer part of the drainage tube above the conical transition, a fixing ring is installed under the occlusive dressing, soldered to the drainage tube, and a moisture-absorbing dressing is placed under the fixing ring.

The disadvantages of this device include the lack of the ability to reliably connect additional devices (Luer-lock, Luer, etc.) and the lack of the ability to manipulate the catheter channel (for example, cleaning), due to the design of the valve.

The closest device in technical essence is the UD-02f disposable, sterile (paramedic) device from the kit for relieving tension and open pneumothorax [13]. This device includes a drainage catheter for relieving tension pneumothorax, a metal stylet needle, and an air valve. All these components are packaged in a single sterile package with a sealing sticker with a valve and a sealing sticker without a valve. In this device, the catheter is glued together in two parts, and its internal lumen is 1.6 mm, compared to its analog.

Disadvantages of the closest alternative include its relatively low effectiveness in relieving tension pneumothorax. The closest alternative, when the catheter is deflected, contributes to lumen obstruction. Furthermore, the catheter's internal lumen, at 1.4 mm, increases the risk of blood clotting. Furthermore, the use of a metal rod to form the channel through which the catheter is inserted reduces the effectiveness (specifically, the accuracy and speed) of channel formation for drainage placement. The alternative also lacks a hole for suturing the drainage to the chest wall skin with a ligature, which may contribute to device migration during evacuation and recurrence of tension pneumothorax.

The technical problem is the need to develop an effective device for eliminating tension pneumothorax, free from the above-mentioned disadvantages.

The technical result consists of increasing the effectiveness of tension pneumothorax treatment, as well as reducing the risk of recurrence and complications. An additional technical result consists of increasing the reliability of fixation and reducing the likelihood of blood clot formation in the catheter lumen during the treatment of tension pneumothorax.

The technical result is achieved in that in a device for eliminating tension pneumothorax, including a catheter with a cannula, a metal stylet needle and a bypass valve, according to the invention, two openings with a diameter of 1.0 to 4.0 mm are made at the distal end of the catheter at a distance of 5 to 35 mm on opposite sides, wherein the internal lumen of the catheter is from 1.0 to 4.0 mm, while in the handle of the catheter there are two openings with a diameter of 0.1 to 1.3 mm.

This design improves the effectiveness of tension pneumothorax repair. 2 mm diameter holes at 10 and 15 mm on opposite sides of the distal end of the catheter prevent blood from clogging the catheter. The 2.4 mm internal diameter of the catheter allows for more effective pneumothorax repair and reduces the risk of blood clot formation within the catheter lumen. 1.0 mm diameter holes for catheter fixation to the skin reduce the risk of catheter migration and improve the effectiveness of tension pneumothorax repair.

In the most preferred embodiment, two holes with a diameter of 2 mm are made at the distal end of the catheter at a distance of 10 and 15 mm on opposite sides, with the internal lumen of the catheter being 2.4 mm, while two holes with a diameter of 1 mm are made in the handle of the catheter.

Also, in the most preferred embodiment of the invention, it is characterized by the following aspects:

- at the distal end of the catheter there is an ergonomic square-section handle and a flange for attaching a bypass valve;

- a catheter with a cannula, a metal stylet needle and an air valve are located in a case, and the case is located in a sterile package;

- the relief valve is made of medical grade silicone rubber;

- the catheter is made of a single piece and is made of a heat-resistant material, whereby the heat-resistant material used is a medical grade polyvinyl chloride thermoplastic polymer composition.

The claimed device is shown in Fig. 1 and Fig. 2. In particular, Fig. 1 shows the claimed device in a longitudinal section in a front view, Fig. 2 shows it in a longitudinal section in a side view, and Fig. 3 shows the catheter separately without the stylet needle in a longitudinal section.

The following positions are shown in the figures:

1 - catheter;

2 - holes;

3 - ergonomic handle;

4 - flange;

5 - thread;

6 - Luer type cone; 7 - stylet needle;

8 - cannula;

9 - centering sleeve;

10 - first (central) hole;

11 - second hole;

12 - connecting body;

13 - cylindrical seat;

14 - bypass valve;

15 - rim;

16 - case body;

17 - cap;

18 - clip;

19 - annular projection;

20 - marks.

The device for eliminating tension pneumothorax is a catheter (1) made of a medical-grade polyvinyl chloride thermoplastic polymer composition with a wide temperature range of elasticity retention. Two black marks (20) are applied along the circumference of the catheter (1): the first one is at a distance of 25 mm, the second one is at a distance of 55 mm. from the proximal end of the catheter, respectively. The marks (20) serve as depth references when inserting the catheter into the pleural cavity. In the distal section of the catheter there are holes (2) used to remove air and fluids from the pleural cavity. Preferably, the total area of the holes is 6.28 mm ² . The holes are located relative to each other at an angle of 180° and at an axial distance of 5.0-35.0 mm, which helps to exclude deformation of the elastic catheter (1) during its insertion. The diameter of the holes (2) is 1.0-4.0 mm. Moreover, the internal lumen of the catheter is 1.0-4.0 mm.

The proximal end of the catheter is atraumatic. The distal end of the catheter (1) is equipped with an ergonomic handle (3) of square cross-section and a flange (4) for attaching a bypass valve. The handle has two holes, allowing the catheter to be secured to the skin by suturing, if necessary. The flange has a double-start external thread (5) and a luer-type cone (6) for connecting medical devices equipped with a luer-lock connector. This catheter is manufactured as a single piece using an injection molding process, which prevents it from breaking during use, unlike glued catheters.

A stylet needle (7) (preferably 2.4 mm in diameter, with sharpening angles of 15 and 60 degrees) is used to form a channel through which the catheter will be inserted. The stylet needle (7) has a metal cannula (8). Two holes with a diameter of 0.1-1.31 mm are made in the catheter cannula. A centering sleeve (9) is placed on the needle. The centering sleeve (9) has two holes (10, 11). One, the central one (10), is used to insert the needle, the second (11), with a diameter of 2 mm, is used to release air when the needle and catheter penetrate the pleural cavity. This hole allows the physician to determine the moment at which further combined use of the needle and catheter is unnecessary and may cause damage to lung tissue with further insertion.

The cylindrical sleeve with the needle (7) and catheter (1) is seated inside the connecting body (12). Fixation is achieved by friction between the two parts. At the opposite end of the connecting body, there is a cylindrical seat (13) for storing the bypass valve (14). The central part of the connecting body has a rim (15) with rounded protrusions, which allows it to be used for more convenient holding of the product during use. The two cylindrical surfaces allow the case body (16) and cap (17) to be held on the connecting body.

The bypass valve (14) is made of medical grade silicone rubber and serves to pass air from the pleural cavity and prevent external air from entering the pleural cavity.

The cap (17) is made of transparent painted polycarbonate and is designed to protect the bypass valve (14) from damage during transportation and use, and it also serves as a palm rest when installing the needle with the catheter.

The case body (16) is made of transparent, colored polycarbonate and serves to protect the needle (7) and catheter (1) from damage. The case body is equipped with a clip (18), allowing the product to be securely attached, for example, in a pocket or first aid kit. An annular lip (19) on the case body ensures the product is watertight.

At the junction of the case body (16) and the connecting body (12), a label is attached indicating the date of manufacture, expiration date and batch number.

All device components are assembled at the factory using assembly procedures, and the device is shipped fully assembled in sterile packaging. The device is intended for single use.

The claimed device operates as follows.

If tension pneumothorax occurs, the device is removed from the case (16) by tearing the limiting paper sticker connecting the case (16) and the connecting body (12). In the 2nd intercostal space, along the midclavicular line, the site for thoracostomy is determined. Using a catheter (1) with a needle (7), a thoracostomy is performed in the 2nd intercostal space, while clamping the catheter (1) in the area of the ergonomic square-section handle (3) with the terminal phalanges of the 1st, 2nd and 3rd fingers of the hand and resting the end with the palm against the cap (17). After puncturing the skin with the sharp edge of the stylet needle (7), a channel is formed perpendicular to the chest wall by immersing the catheter up to the second black mark (20) located on its body (1). Then, the stylet needle (7) and the connecting body (12) with the protective cap (17) located on its distal end are removed from the lumen of the catheter (1). After removing the needle (7) from the lumen of the catheter (1), the latter is advanced into the pleural cavity until it stops in the area of its square-section handle (3). The protective cap (17) is removed from the connecting body (12), the release valve (14) is moved to the distal end of the catheter (1) in the area of the flange (4). The valve (14) is securely fixed in the area of the double-start external thread (5) and the luer-type cone (6) of the flange (4). The air accumulated in the pleural cavity enters through the holes (2) of the catheter (1) and is released through the valve (14). The catheter is secured to the chest wall by suturing it with surgical thread passed through the holes in the area of the square-section handle (3) of the catheter (1). If it is not possible to secure the catheter with surgical thread, it is secured to the skin of the chest wall with adhesive tape. The remaining parts of the kit after drainage of the pleural cavity: the case (16), the needle (7) with the connecting body (12) and the protective cap (17) are combined, placed in the pocket of the casualty's uniform and sent with him. In the event of obstruction of the catheter lumen during evacuation by a blood clot, it is possible to restore the catheter's patency using the needle (7) with the connecting body (12) and the protective cap (17).

The claimed invention is illustrated by examples.

Example 1

Experimental studies of a large number of samples were conducted.

The experiment was conducted in a specialized operating room for performing surgical interventions on large laboratory animals, where the necessary material and technical support and trained qualified personnel were available according to the standard methodology for modeling tension pneumothorax in large animals using a pig as an example [14].

The experimental studies were conducted in 4 stages:

- 1st stage - preparatory stage;

- Stage 2 - modeling of tension pneumothorax on a large laboratory animal (pig);

- Stage 3 - use of the claimed device to eliminate tension pneumothorax;

- Stage 4 - evaluation of the effectiveness of the device for eliminating tension pneumothorax.

In the example, a large number of samples of the device according to the claimed invention were used with different parameters shown in Table 1.

Table 1.

Animal number Distance from distal end to hole 1, mm Distance from distal end to hole 2, mm Diameter of holes at the distal end of the catheter, mm Internal lumen of the catheter, mm Diameter of holes in the handle, mm 1 4.0 35.0 2.0 2.4 1 2 5.0 35.0 2.0 2.4 1 3 10.0 15.0 2.0 2.4 1 4 15.0 35.0 2.0 2.4 1 5 15.0 36.0 2.0 2.4 1 6 10.0 15.0 0.9 2.4 1 7 10.0 15.0 1.0 2.4 1 8 10.0 15.0 4.0 2.4 1 9 10.0 15.0 4.1 2.4 1 10 10.0 15.0 2.0 0.9 1 11 10.0 15.0 2.0 1.0 1 12 10.0 15.0 2.0 4.0 1 13 10.0 15.0 2.0 4.1 1 14 10.0 15.0 2.0 2.4 0.1 15 10.0 15.0 2.0 2.4 1.3 16 10.0 15.0 2.0 2.4 1.4

As a result of the tests, the device sample used on animal 3 showed the best results. Good results were shown by the devices used on animals 2, 4, 6-8, 11, 12, 15. Poor results were obtained for animals 1, 5, 9, 10, 13, 14 and 16.

Example 2.

Experimental studies of the effectiveness of the modernized drainage catheter samples were conducted as part of standard tests. The experiment was carried out in a specialized operating room for performing surgical interventions on large laboratory animals, where the necessary material and technical support and trained qualified personnel were available according to the standard methodology for modeling tension pneumothorax in large animals using a pig as an example [14]. In this study, devices were used including a catheter with a cannula, a metal stylet needle and an air valve, fixed in sterile packaging. Moreover, the catheter is made of a single piece and a heat-labile material, and at the distal end of the catheter, at a distance of 10 and 15 mm on opposite sides, two holes with a diameter of 2 mm are made, and the internal lumen of the catheter is 2.4 mm, while in the handle of the catheter there are two holes with a diameter of 1 mm. Experimental studies were carried out in 4 stages:

- 1st stage - preparatory stage;

- Stage 2 - modeling of tension pneumothorax on a large laboratory animal (pig);

- Stage 3 - use of the claimed device to eliminate tension pneumothorax;

- Stage 4 - evaluation of the effectiveness of the device for eliminating tension pneumothorax.

The table shows the results of the experimental verification. drainage catheter with a stylet needle to eliminate tension pneumothorax.

Table 2 Indicator Study Animal 1 Animal 2 Animal 3 Animal weight, kg 51.2 65.0 67.9 Stage I. Preparatory stage Tracheostomy No special features No special features No special features Access to BA and BV Ultrasound-guided access to the BA and BV Ultrasound-guided access to the BA and BV Ultrasound-guided access to the BA and BV Stage II. Modeling tension pneumothorax in a large animal X-ray examination of the chest, initial control No. 1 pathological changes are absent pathological changes are absent pathological changes are absent Background indicators Saturation, % 96 97 97 Respiratory rate, mmHg 14 12 15 Heart rate, mmHg 76 100 90 BP, mmHg (Sitolic/diastolic) 100/75 105/54 159/82 Creation of carboxythorax Saturation, % 89 90 90 Respiratory rate, mmHg 23 22 20 Heart rate, mmHg 153 126 140 Blood pressure, mmHg (Systolic/diastolic) 80/45 85/48 100/65 Chest X-ray - Control No. 2 (confirmation of tension carboxythorax) result "+" result "+" result "+" Stage III. Use of a drainage catheter with a stylet needle SK Exposure (waiting) - 10 min. Saturation, % 95 96 95 Respiratory rate, mmHg 12 12 12 Heart rate, mmHg 136 107 120 Blood pressure, mmHg (Systolic/diastolic) 95/60 100/65 130/85 Chest X-ray - control No. 3, confirmation of pleural drainage result "+" result "+" result "+" Elimination of tension pneumothorax using a modernized device The drainage is installed, air under pressure comes out of the pleural cavity The drainage is installed, air under pressure comes out
pleural cavity The drainage is installed, air under pressure comes out of the pleural cavity Stage IV. Evaluation of the effectiveness of a drainage catheter with a stylet needle 2 minutes after drainage installation. Evaluation of air release through drainage (pleural cavity decompression) The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve 5 minutes after drainage placement. Hemodynamic monitoring No. 3 Saturation, % 94 95 95 Respiratory rate, mmHg 12 13 12 Heart rate, mmHg 119 85 90 BP, mmHg (Sitolic/diastolic) 92/60 95/60 120/80 Evaluation of air release through drainage (decompression of the pleural cavity). The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve 10 minutes after drainage installation Chest X-ray - Control No. 4 Tension pneumothorax has been eliminated Tension pneumothorax has been eliminated Tension pneumothorax has been eliminated Evaluation of air release through drainage (pleural cavity decompression) The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve The air release valve functions "+",
there is no reverse flow of air into the pleural cavity through the valve 1 hour after drainage installation Chest X-ray - Control No. 5 Tension pneumothorax has been eliminated Tension pneumothorax has been eliminated Tension pneumothorax has been eliminated Saturation 95 (Restored) 95 (Restored) 96 (Restored) respiratory rate 14 12 13 heart rate 110 95 87 BP, mmHg (Sitolic/diastolic) 100/65 110/60 130/85 Animal survival rate Survived Survived Survived

The study demonstrated the high efficacy of the proposed device for relieving tension pneumothorax. The internal diameter of the lumen and the proposed design features of the catheter enable effective relieving of tension pneumothorax. This is confirmed by the restoration of cardiovascular and respiratory parameters in the experimental animals.

Bibliography

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Claims (4)

1. A device for eliminating tension pneumothorax, comprising a catheter with a cannula, a metal stylet needle and a bypass valve, characterized in that at the distal end of the catheter at a distance of 5 to 35 mm on opposite sides there are two holes with a diameter of 1.0 to 4.0 mm, wherein the internal lumen of the catheter is from 1.0 to 4.0 mm, at the proximal end of the catheter there is a square section handle and a flange for attaching a bypass valve, in the handle there are two holes with a diameter of 0.1 to 1.3 mm for fixing the catheter to the skin, a centering sleeve is put on the stylet needle, in which two holes are made, one of which is made for installing the needle, and the second - for the release of air when the stylet needle with the catheter penetrates the pleural cavity, the sleeve with the stylet needle and the catheter is seated in the inner part of the connecting body, from the opposite end which has a seat for storing the bypass valve, the connecting body is designed with the ability to hold on it a case for protecting the stylet needle with the catheter and a cap for protecting the bypass valve, wherein the stylet needle is designed with the ability to be removed from the lumen of the catheter with the connecting body with the cap located at its end. 2. The device according to item 1, characterized in that the bypass valve is made of silicone rubber. 3. The device according to item 1, characterized in that the catheter is made as a single piece from a heat-labile material. 4. The device according to paragraph 3, characterized in that the heat-labile material is a polyvinyl chloride thermoplastic polymer composition.