JPH0747118A - Reinforcing medical surgical tube and its production - Google Patents

Abstract

PURPOSE: To provide a reinforcing medical surgical tube such as a catheter which causes no kink nor destruction in being used and is finished into a sufficient smoothness for insertion. CONSTITUTION: A tracheal tube 9 is so formed that a spiral filament 15 is wound around the circumference of a continuous flexible base tube and an outer layer is formed thereon. The tracheal tube 9 is cut at an angle approximately 45 deg. so that a distal end 10 is formed, and the distal end 10 incorporates a spiral filament coil so that the cut surface is treated by dissolved plastic to prevent the coil 21 from being exposed and the end is finished into a round surface.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to reinforced catheters, tracheal tubes, tracheostomy tubes, and other medical and surgical tubes and products derived therefrom. More particularly, it relates to the manufacture of a medical surgical tube having a central body portion that includes a stiff, rigid plastic filament that strengthens the tube of the present invention to resist kinking and crushing during use.

[0002]

BACKGROUND OF THE INVENTION The present invention holds a catheter in a desired position within a patient or seals a conduit within a patient during cuffless and balloon type catheters, ie, medical or surgical procedures performed using the catheter. Operative inflatable balloon or cuff can be provided at the distal end.

Medical surgical tubes can come in a variety of sizes and shapes and can be provided with a variety of fluid openings, couplings, connectors and the like. For example, a doctor,
Users such as surgeons and hospitals can use these devices to
For example, although it is often called a rectal catheter, a urethral catheter, a hemostatic catheter or the like, a tube, for example, an endotracheal tube, a supply tube, an inhalation tube, a drainage tube or the like is also called. For clarity of explanation of the improved device and method of manufacture of the present invention, the term "catheter" is used throughout the specification and patents, even though the term "catheter" is commonly referred to by medical professionals and other users as "catheter" or "tube." It is intended to cover the patient's medical surgical device throughout the claims.

Various forms of medical surgical tubing are known that have holes that allow fluid to pass through to the body of a patient. The simplest of these is a catheter (US Pat. Nos. 2,437,542 and 2,857,9).
No. 15, No. 3,485, 234, No. 3,605, 75
0, 3,618,613 and 4,210,47
(See No. 8). As a more complicated medical surgical tube, an endotracheal tube (U.S. Pat. Nos. 3,625,793 and 3,6) is used.
84,605, 3,725,522 and 3,7
55,525), post-surgical tubes (US Pat. No. 3,589,368), tracheostomy tubes (US Pat. No. 3,973,569), drainage tubes (US Pat. No. 3,314,314). 430), urological tubes (US Pat. No. 2,268,321) and esophageal endoprosthesis tubes. The present invention provides an improved medical surgical tube and method of making the same, the medical surgical tube having a new distal end.

[0005]

It is desirable for most medical surgical tubes to be flexible and have as thin a wall as possible. However, the construction of a thin walled and highly flexible medical surgical tube is subject to conditions, and the thinner and more flexible the tube is, the more likely it is to kink or collapse during use. The medical surgical tube must be configured to reduce kinks, as kinks and crushing can result in complete hole closure and patient damage and death.

One method developed to provide a strong, but not necessarily kink prone, medical surgical tube is a braided wire sheath (UK patent application GB204320) embedded between plastic layers in the tube.
1A) or a helical metal wire or synthetic filament (see Canadian Patent No. 1,199,761). A tube containing such a helix is said to be "reinforced". In a reinforced tube, the spacing between the spiral coils is very small, for example
3 mm, configured as a tube such as a catheter having a filament that increases tensile strength and burst strength instead of compressive strength (see US Pat. No. 2,268,321).
The distal end of the catheter shown in FIGS. 11-13 of US Pat. No. 2,268,321 is not reinforced by helical filaments such that multiple coils of helical filament are provided at the distal end.

However, the metal wire reinforcing tube has a drawback that it does not bounce when it is partially collapsed. For example, when a patient bites into a metal wire reinforced tracheal tube, the metal wire will deform beyond its elastic limit and the tube will remain in a collapsed state. Such collapsing of the tube closes the hole almost completely and poses a risk to the patient. On the other hand, the filament reinforced tube has a high resistance to kinking and crushing because it rebounds when crushed.

Various methods of providing a distal end for such medical surgical tubes are known in the art. For example,
Continuous extruded tubes can be square cut at the near end and beveled at the far end. This cutting is easy with pure plastics without reinforcement. Subsequent finishing of the far end can be accomplished by pressing the angled cut end into a heated mold which melts the PVC into the shape of the mold (US Pat. No. 3,725,522 and Canadian Patent). (See No. 1,199,761). With this technique, the rectangular edge at the tip cut at an angle is made smooth and can be rounded. You can punch an eye in the long part at the far end. This can be done by placing a flat mandrel inside the tube and punching the wall with a cookie cutter punch.

However, for wire reinforced extruded tracheal tubes, complicated and costly termination finishing methods have been used in the past (see GB2043201A and Canadian Patent No. 1,199,761). For example, a method of finishing the distal end of a stiffening tube involves placing a square cut end in an injection mold and forming a complete tip from pure plastic while simultaneously melting it into the stiffening tube. Also, the (wireless) pure plastic tip can be made by separately extruding a pure plastic tube having the same ID (inner diameter) and OD (outer diameter) as the reinforcing tube, and the tip is fixed to the tube by a solvent or glue. be able to. Another method involves stripping the wire from between the inner and outer walls of the tube at the far end of a simple square cut, where the two walls are glued together and then the tip is angle cut and thermoformed to give an eye. Punch out. Also, provide a spiral or sheath portion that is spaced (for example, by intermittently stopping the winding of the filament or sheath around the base tube) and cut the tube into the spiral portion of the tube. It is also possible to form the far end.

The prior art catheter shown in FIG. 1 comprises a central body portion 4 which includes a shaped distal distal end 2 of the spiral, a proximal proximal end 3 of the spiral and a helix 5 (see FIG. 2). Before forming the shaped distal end 2 on the catheter 1 to protect against the possibility that the distal end of the helix 5 will penetrate the outer layer of the catheter 1 during use (especially if made of metal wire). A small loop 6 is formed at the far end of 5 (see Figure 3). The distal end 8 of the rigid molded connector 7 is surrounded by the somewhat extended proximal end 3 of the catheter 1.

Prior to the present invention, creating the distal end of a reinforced medical surgical tube was a labor-intensive task (Canadian Patent No. 1199976 and GB 20432).
01A). Further, such a far end was provided without reinforcement to increase its compressive strength. The present invention is directed to an improved method for producing a distal end of a rigid plastic filament reinforced medical surgical tube that is less costly and more uniform than ever before.

[0012]

SUMMARY OF THE INVENTION The primary object of the present invention is to provide a new reinforced medical surgical tube and a new method of producing a distal end of such a medical surgical tube.

The object of the invention is its far end (ie tip).
The goal is to provide a catheter that is filament reinforced and finished with sufficient smoothness for intubation. The present invention appears to be of great market value as it can replace and replace all metal wire reinforced medical tubes, at least metal wire reinforced tracheal tubes. Non-metal filament reinforced tubes with a smooth finish in accordance with the present invention are often superior to metal wire reinforced tubes and can be manufactured more economically.

In an embodiment, a medical surgical tube is reinforced with helical filaments such that multiple coils of helical filament are provided at the distal end of the tube, and the tube is simply angle cut or square cut to be stripped or otherwise manipulated. Without forming the far end, which is then finished in a relatively simple manner. In particular, the medical surgical tube may comprise a filament reinforced tracheoplasty or tracheal tube in which the filament extends all the way to the distal end face and the distal end is easily finished.

In accordance with the present invention, a continuous flexible base tube is first extruded, the extruded tube is cooled, a spiral filament is wrapped around the cooled tube, and then an outer layer is wound onto the spiral and base tube. A reinforced medical surgical tube is extruded to form the final laminated tube, and the final tube is cut into lengths and finally a distal end containing at least one filament is formed on each cut of the final tube. It can be manufactured.

The distal end containing the filament has a donut-shaped plastic piece inserted into the heated mold to form a plastic piece on the tube portion before the cut end of the final tube is inserted into the mold to form a tube end. It can be finished by forming a rounded tip or end face. Alternatively, the filament-containing end can be finished by simply melting the filament-containing distal end of the cut end of the final tube.

[0017]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A medical surgical tube according to the present invention has a central body 11
It consists of a medical surgical tube, such as a tracheal tube 9 having a distal end 10 and a proximal end (not shown) that include filaments that are joined together by (see FIG. 4). Tracheal tube 9
Has a main hole extending the entire length of the tube and may have a secondary hole 12 formed in the wall 13 of the tracheal tube 9 (see FIG. 5). The secondary hole 12 may open into the balloon cuff 14 near its distal end and an inflation tube (not shown) having a pilot balloon (not shown) and a check valve (not shown) near or near its proximal end. (Not shown).

The central body portion 11 of the tracheal tube 9 includes a helical filament 15 and the proximal end can be filament free. On the other hand, the distal end 10 includes means consisting of multiple coils of helical filaments 15 to provide the compressive strength of the distal end 10 when compared to a tube that does not include such helical filaments. The tube 9 may be made of a flexible material such as plasticized polyvinyl chloride, polyurethane and silicone rubber, and the connector element (not shown) attachable to the proximal end of the tube 9 may be made of nylon, polypropylene, It can be molded with a rigid material such as acrylic resin and polystyrene.

The tracheal tube 9 is made in various sizes. Typically the length of such a tube is around 10
˜40 cm, the inner diameter (“ID”) of the main hole is approximately 2.0-10.0 mm, and the outer diameter (“OD”) is approximately 2-3 mm larger than the diameter of the main hole. Other types of tubing in accordance with the teachings of the present invention can be sized to suit the application.

Preferably, the helical filaments 15 are formed of rigid plastic filaments having a diameter of approximately 0.1 to 0.5 mm, the spacing between the individual coils of the filament being generally greater than 1 turns per tube diameter. It can be large, preferably 5 to 10 times per tube diameter. For example, 7 mmI. D. In the case of tubes, the intercoil spacing may be approximately 1-3 mm. However, the filament diameter and spacing between the individual coils can be varied to suit the tube application. Various types of rigid plastic filaments can be used to form helices such as nylon monofilaments, polyester filaments and poly (ethylene) terephthalate (“PET”, “PET”).

The manufacture of the tracheal tube 9 according to the invention is carried out as follows. First, a continuous tube of flexible material, such as plasticized polyvinyl chloride, polyurethane and silicone rubber, is extruded. The base tube can have a wall thickness that is approximately half the desired thickness of the final tube.

The extruded tube is then removed from the extrusion mold and passed through a cooling bath to be cooled, and then the filament is wound around the cooled tube to form a base tube. Form a helix that extends longitudinally along the outer surface. According to the present invention, the helix can be continuous along the entire length of the base tube. Once the helix has been wrapped around the base tube, the assembly is passed to a second extruder where the outer layer is extruded onto the base tube and helix combination, as shown in FIG. Forming a continuous flexible final tube with a spiral laminated between the outer layers. During this second extrusion, a suitable mold can be used to form at least one secondary hole 12 in the outer layer. The outer layer can be formed of the same material as the base layer. Also, the inner and outer layers can be formed of different materials.

According to the invention, the tracheal tube 9 is reinforced all the way to the tip by means of a helical filament, the tip being simply cut into a square so that the end face lies in a plane forming an angle of 90 ° with the central axis of the tracheal tube 9. Or the angle is such that the end face lies in a plane that makes an angle other than 90 ° to the central axis of the tracheal tube 9.
For example, as shown in FIG. 4, the distal end can be cut at an angle of approximately 45 ° without stripping or other operations and then the tip can be finished in a relatively simple manner.

Thus, the method according to the present invention may include coextruded filament reinforced tracheal tubing. The termination finishing technique according to the invention is economical and simple for such filament reinforced tubes, since the ends of such tubes can be cut off using conventional techniques.

The termination finishing technique according to the present invention either melts the square cut 16 or angle cut 17 ends directly, or a small washer of plastic prior to inserting the distal end 10 of the final tube into a mold (not shown). Melting by placing the doughnut-shaped donut 18 (FIGS. 6 and 7) in a mold. In an embodiment, the washer-like donut 18 has an axial (A) thickness approximately equal to the wall thickness of the final tube (FIG. 6), and can have an annulus of a filamentless tube. The axial thickness of the washer donut 18 should be sufficient to provide a thin layer which, when melted, coats the exposed ends of the helical filaments. Therefore, after the washer-shaped donut 18 is melted, the raw end 1 of the cut spiral filament 15 which should be exposed as a cutting edge when the tracheal tube 9 is inserted into an opening of the body such as the trachea.
9 is coated. However, the end face of the distal end 10 can be melted or the ends of the filaments cut by any other suitable method can be properly covered with a thin layer of material so that a plastic washer-like donut 18
Can be omitted.

A plastic washer-like donut 18 can also be used to incorporate an X-ray opaque pigment to view the tube opening in the patient's body by X-ray.

Thus, the reinforced medical surgical tube of the present invention comprises a flexible material tube and a rigid plastic spiral filament 15 disposed coaxially with the tube and between the inner and outer peripheries of the tube, comprising a plurality of spiral filaments. A coil is provided at the distal end 10 of the tube to increase the compressive strength of the distal end, which includes the axial end face 20. In the case of the angle cutting end 17, the individual coils of the helical filament 15 are separated into a plurality of individual pieces at the distal end 10 by the cutting step. In particular, the spiral filament coil 21 is discontinuous with respect to each other, and the free end 19 of the cut filament has an end face 20 after the cutting step.
Are exposed at (see FIG. 8). Due to the angle cutting end 17, each discontinuous coil of the spiral filament has a short circumferential length at a position close to the axial end face 20, and the free ends 1
At least some of the discontinuous coils with 9 facing the axial end face 20 but a thin layer of flexible material formed by melting the end face 20, a plastic washer-like donut 18 melted onto the end face or optionally It is spaced inwardly from it by any other suitable method. The thin layer may have a maximum thickness between the end face 20 and the filament portion closest thereto that is approximately twice the distance between adjacent coils of the spiral filament 15. For example, the lamina can have a maximum thickness of approximately four times the wall thickness of the tube. In addition, the distal end 10 of the tube has an opening or eye 22 between its inner and outer circumferences.
Can be extended.

In accordance with the present invention, a reinforced medical surgical tube can be manufactured that is much less costly and much more uniform than before and can be treated as a one-time disposable tube. The resulting products are individually packaged and sterilized by exposure to, for example, ethylene oxide gas or Cobalt 60, ready for use by the physician or other user after removal from the sterile packaging.

The present invention can be used in the manufacture of any type of reinforced medical surgical tube currently used by physicians or developed in the future.

Although the present invention has been described with reference to an embodiment,
Changes and modifications may be made within the scope of the claims.

[Brief description of drawings]

FIG. 1 is a lateral view of a prior art catheter.

FIG. 2 is a sectional view taken along line 2-2 of FIG.

3 is a sectional view taken along line 3-3 of FIG.

FIG. 4 is a perspective view of a medical surgical tube manufactured in accordance with the present invention.

5 is a cross-sectional view taken along line 5-5 of FIG.

FIG. 6 is a longitudinal cross-sectional view of a tracheal tube according to the present invention prior to finishing the distal end in a mold using a washer-like donut.

7 is a cross-sectional view of the washer-shaped donut taken along line 7-7 of FIG.

FIG. 8 is a perspective view of a tracheal tube according to the present invention before a finishing step.

[Explanation of symbols]

 1 Catheter 2 Far End 3 Near End 4 Central Body 5 Helix 6 Loop 7 Molding Connector 8 Far End 9 Tracheal Tube 10 Far End 11 Central Body 12 Hole 13 Wall 14 Balloon Cuff 15 Spiral Filament 16 Square Cutting Termination 17 Angle Cutting Termination 18 washer-shaped donut 19 end 20 axial end face 21 coil 22nd

Claims (21)

[Claims] 1. A method of manufacturing a reinforced medical surgical tube each having a distal end and a proximal end joined by a central body portion, the method comprising: extruding a continuous flexible base tube; and extruding the extruded tube. Cooling, winding a spiral continuous rigid plastic filament around a cooled continuous tube, and extruding an outer layer of flexible material onto the base tube and spiral filament to form a base tube and outer layer Forming a continuous flexible final tube in which at least one spiral filament is laminated to the spiral tube, and cutting the final tube to cut the spiral filament to form at least one cut filament end into a final tube. To expose it on the end face of the far end of the Forming a material layer so that the cut filament ends are not exposed at the distal end of the final tube. 2. The manufacture of a reinforced medical surgical tube according to claim 1, wherein the cutting step is an angle cutting step such that the end face is in a plane that forms an angle other than 90 ° with respect to the central axis of the final tube. Method. 3. The method for manufacturing a reinforced medical surgical tube according to claim 1, wherein the cutting step is a rectangular cutting step in which the end face is in a plane forming an angle of 90 ° with respect to the central axis of the final tube. . 4. The method of manufacturing a reinforced medical surgical tube according to claim 1, wherein the outer layer and the base tube are extruded from the same material. 5. The method of manufacturing a reinforced medical surgical tube according to claim 1, wherein the thin layer is formed by placing the distal end in a mold and melting the end surface of the distal end of the tube. 6. The thin material layer at the distal end is formed by melting washer-shaped material pieces on the distal end,
The method for manufacturing a reinforced medical surgery tube according to claim 1. 7. The method of manufacturing a reinforced medical surgical tube according to claim 1, wherein the cutting step is performed by making a single cut in the final tube such that the helical filaments are separated in only one position. 8. The method of manufacturing a reinforced medical surgical tube of claim 1, wherein the cutting step is performed by making a single cut in the final tube such that the helical filaments are separated at multiple locations. 9. The method of manufacturing a reinforced medical surgical tube according to claim 1, wherein the forming step includes shaping the end surface to form a rounded edge at the distal end of the final tube. 10. A flexible tube, a spiral filament coaxial with the tube, disposed between the inner and outer peripheries of the tube and extending along the tube to its distal end, and a distal end for increasing the compressive strength of the distal end. It has multiple coils of spiral filament at the end, the far end includes the far end face, the spiral filament is separated from the far end face by a thin layer of flexible material, and the cut end of the spiral filament is at the far end. Reinforcing medical surgical tube comprising means to prevent exposure at the surface. 11. The end face is 90 degrees with respect to the central axis of the tube.
In a plane at an angle other than °, the spiral filament includes a plurality of cut filament ends facing said plane, at least some coils of the spiral filament are discontinuous with each other, and the circumferential length of the coil is 11. The reinforced medical surgical tube of claim 10, wherein is short near the axial end face and at least some of the ends of the coil face the axial end face and are separated therefrom by the thin layer of material. 12. The reinforced medical surgical tube of claim 10, further comprising at least one eye extending between the inner and outer peripheries of the tube at the distal end of the tube. 13. The reinforced medical surgical tube of claim 11, wherein the thin layer of material separating the ends of the coil from the axial end surface comprises a piece of melted washer-like material. 14. The reinforced medical surgical tube of claim 13, further comprising at least one secondary hole disposed between the inner and outer circumferences of the tube. 15. The reinforced medical surgical tube of claim 14, wherein the at least one secondary hole is located between the spiral filament and the outer circumference of the tube. 16. The augmented medical surgery according to claim 10, wherein the coils of spiral filaments are separated from each other in a direction parallel to the central axis of the tube so that the number of turns of the spiral per tube diameter is greater than 1. tube. 17. The filament is approximately 0.1-0.5.
The reinforced medical surgical tube according to claim 16, having a diameter of mm. 18. The reinforced medical surgical tube of claim 10, wherein the end surface comprises a smoothly rounded edge extending between the inner and outer circumferences of the tube. 19. The reinforced medical surgical tube of claim 10, wherein the lamina has a maximum thickness between the end surface and the filament portion closest thereto approximately four times the wall thickness of the tube. 20. The end face is 90 degrees with respect to the central axis of the tube.
The reinforced medical surgical tube according to claim 10, which is in a plane forming an angle of °. 21. The reinforced medical and surgical tube according to claim 16, wherein the number of turns of the spiral per tube diameter is in the range of 5 to 10.