DE102006023637A1 - Tracheostoma placeholder for use in trachea opening e.g. tracheostoma, has tubular support structure that is expandable from initial condition into support condition, where diameter of support structure is increased in support condition - Google Patents

Abstract

The placeholder has a tubular support structure (9) that is expandable from an initial condition into a support condition (S), where diameter of the support structure is increased in the support condition. The support structure exhibits fixing units (14, 15, 17) at its ends (12, 13), where the fixing units are arranged opposite to each other. The fixing units protrude transverse to a middle longitudinal axis (MLA) of the support structure over an outer periphery of the support structure in the initial condition, where length of the support structure is adjustable. Independent claims are also included for the following: (1) a tracheostomy method (2) a device for inserting a tracheostoma placeholder.

Description

The The invention relates to a tracheostoma spacer with a tubular scaffold, a Tracheostomy procedure and device for introducing a Tracheostomy placeholder.

Tracheotomy or tracheostomies are medical interventions that are performed when a human about a longer one Period intubated, malformations, diseases or Upper respiratory tract injuries cause an acute Closure forms or danger of suffocation threatens. An operationally designed Trachea opening will referred to as tracheostoma. To produce such a trachea opening are several Procedures known: percutaneous dilatation tracheotomy, percutaneous Puncture tracheostomy, surgical tracheostomy, ENT-medical tracheostomy and the Tracheostomy for laryngectomy.

The The present invention relates to percutaneous tracheotomy procedures. This is where the trachea becomes dotted with a hollow needle or pierced with a trocar. The resulting opening becomes expanded and final a tube in the opening placed. As part of percutaneous dilatation tracheotomy usually first a guidewire in the opening introduced, which is then widened with an inflatable balloon. Bleeding on The wound site will then be affected by the extreme pressure of the surrounding area Tissue breastfed.

Problematic At the percutaneous tracheotomy procedure is that the tracheostomy within the shortest possible time Time after removal of a cannula placed in the tracheostoma or Close the tube again and a re-introduction after a short time is difficult to impossible. That's why In the past, various wildcards have been developed that the Tracheostoma should be kept open. A disadvantage of the known placeholders is that they are a relatively large one Have diameter, so that the tracheostomy must be correspondingly large. Furthermore, the tubular scaffolds are often rigidly executed and can Therefore, not to the anatomy of the trachea or the tracheostoma to adjust.

Of the On this basis, the invention is based on the object, a tracheostoma placeholder according to the preamble of claim 1, a tracheotomy procedure and a device for the introduction to show such a tracheostomy placeholder, in which the tracheostomy is made smaller can be and / or less stretched.

Of the representational Part of the task is characterized by a tracheostoma wildcard with the features of claim 1 solved.

This Tracheostomy placeholder is characterized in that the scaffold from an initial state in an enlarged diameter support state is expandable and has a fixing end.

Of the Advantage of this solution is that the tracheostomy placeholder in a crimped initial state introduced into the tracheostoma can be and has a very small diameter and after placing in one of the physiological and clinical requirements corresponding diameter is widened, for example by an inflatable balloon or a rigid dilator or a another, comparable instrument, wherein the tracheostoma is additionally stretched. Thus, a placeholder is provided, which is very low Effort is customizable and very well tolerated. Through the end Fixing element, either on the outside of the skin or on the inside in the trachea is arranged, effectively prevents the placeholder the tracheostoma can be pushed out or sucked.

advantageous embodiments and further developments of the tracheostomy-Platzhalter are the subject of dependent claims 2 to 32nd

Especially Advantageously, the scaffold of a Initial state self-expanding into an enlarged diameter support state. Thus, no active expansion of the opening is required. The spring forces, the the scaffold due of its material and design are dimensioned sufficiently strong, to effect a widening of the tracheostoma.

advantageously, is the length adjustable to the scaffold. this makes possible the adaptation of the tracheostoma wildcard to an individual Stromal depth. The Adjustability can be ensured by a two-piece scaffold, whose parts telescopically slidable. Furthermore, self-adjusting Scaffold geometries conceivable that by twisting, twisting or tilting a setting the length allow the scaffold. The length setting can also be effected by the spring force of the scaffold. By a appropriate design and choice of materials, the scaffold can be designed be that at an extension the diameter is reduced and vice versa. The restoring forces that effect this can be between 0.05 lbs (0.023 kg) and 0.5 lbs (0.23 kg). In this way Imagine, of course, an anatomically correct length of the Scaffolding in accommodation to the Stroma depth.

The Fixing element has atraumatic edges. This ensures that that the fixation does not cut into the tissue of the trachea or irritate the tissue in any other way. Appropriately, the edges of the fixing are rounded.

The Fixing element is in the support state across to the central longitudinal axis of the scaffold over its outer periphery in front. In this way a stop is formed which effectively prevents that the tracheostomy placeholder pushed out of the tracheostoma or can be sucked.

Appropriately, are two at one end of the scaffold Fixing provided. The division into several fixing elements leads to each made smaller can and can the input and output of the tracheostoma wildcard is facilitated. Advantageously The fixing elements for insertion and removal can be folded. Therefore, must the tracheostoma is not significantly larger than the outside diameter of the scaffold in the Be initial state.

advantageously, the fixing elements of one end of the scaffold are opposite each other arranged. This design facilitates self-alignment of the Tracheostomy insert in the trachea in adaptation to the anatomical Conditions.

Especially It is advantageous if fixing elements are provided at both ends of the scaffold. These prevent in one direction pushing out the Tracheostomy placeholder from the tracheostoma and in the other Direction to push or suck into the trachea. The tracheostomy placeholder is thus determined on all sides.

Appropriately, are the fixing of one end to the fixing of the other end at a right angle around the central longitudinal axis twisted the scaffold arranged. By this arrangement, the self-alignment of the Tracheostomy wildcard in tracheostomy favorably supported. The in the trachea located fixing elements will orient themselves in the vertical direction, there the trachea concave inside. Accordingly, the fixing on the outer skin surface in horizontal Align the direction so that movements of the head forward and Not affected by the tracheostoma spacer. About that In addition, it is conceivable that the tracheostoma placeholder in the trachea assumes a support function.

One Fixing element has a recess. The recess facilitates favorably grasping the tracheostomy insert, for example to remove it from the tracheostoma. The recess can circular, be oval or elliptical.

The Scaffold can Hose guides exhibit. Such hose feed elements facilitate insertion of hoses, to the feeder from oxygen to the lungs or to suck mucus out of the Lungs or trachea needed become. Preferably, the hose guide elements extend over a End of the scaffold out. This end should be in the trachea and more preferred be curved or have a shoulder to divert the hoses in To cause the direction of the lungs. The tube can thus be inserted into the trachea, that he has a desired Distance from the back wall the trachea and not against the back wall pushes or Tracheal mucous membranes otherwise exhausted.

Further is the scaffold one Valve unit assigned. With the valve unit can be advantageous by inhaled the tracheostomy and exhaled through the trachea. Under circumstances is the patient able to continue to speak. In addition, you can Instruments from the outside be inserted through the tracheostoma. The valve unit is either from the outside insertable or a part of a sheathing of the scaffold. at the second solution would be one Part of the sheath designed as duckbill-shaped membrane.

In A further embodiment provides that the scaffold a humidifier assigned. In this way, the sucked into the lungs Humidified respiratory air. The humidifier consists of a molded body, the Absorb moisture during exhalation and release it when inhaled.

Appropriately, is a coupling element for fixing carried out in the scaffold or inserted objects intended. Such objects For example, the valve unit, the humidifier or a hose.

The scaffold is surrounded by a shell. The sheath protects the tissue adjacent to the tracheostomy insert and facilitates the insertion and removal of the tracheostomy insert, because, among other things, the sheath causes an advantageous increase in the lubricity of the tracheostomy insert. For this purpose, the sheath may further comprise a hydrophobic or hydrophilic lubricious coating. By the sheathing is further an adhesion of the adjacent tissue to the tracheostomy ma placeholder prevented. The sheath may have a nanomolecular coating. The sheath may further consist of a polymer. In this way, the expandable scaffold is not inhibited in its expansion. The sheath may further contain pharmaceutically active ingredients which have anti-inflammatory, bacterial or microbial defense or contain tissue growth modulators or regulators to prevent granuloma growth or to promote endothelialization. Further suitable active ingredients are, for example, saline solutions, wound ointments and lidocaine (a locally acting anesthetic). The active ingredients may be provided in the form of fluids.

Further can in the scaffold a reservoir, the an opening on the outer peripheral side of the scaffold, and / or a channel having an end on the peripheral side of the scaffold, be provided. The fluids can be stored in the reservoir. By the opening can the fluids reach the outer peripheral surface, so that they act directly on the adjacent tracheostoma tissue can, whereby the insertion and removing the tracheostomy spacer facilitates and the compatibility is generally improved. Through the channel, the fluids can at any time Need and in the needed Amount be injected.

The Scaffold points an annular Cross-section on. This embodiment has proved to be particularly advantageous as a production technology. The scaffold can but also have an oval cross-section. Of course they are Other cross-sectional shapes conceivable within the scope of the invention. These cross-sectional shapes become an adaptation to the anatomy the trachea, in particular to the surrounding cartilage rings. Furthermore, the scaffold in cross section have a dent and / or a bulge. Also a kidney-shaped cross-sectional shape is conceivable.

The Scaffold points Struts of filaments on. Thus, a scaffold is created, which in his Diameter variable is. The filaments can Made of a metal. In particular, a shape memory alloy is suitable, such as nitinol. Due to the metallic design is supports the resilient self-expansion of the scaffold and the durability of the Tracheostomy placeholder increased. By using a shape memory alloy, the diameter change In addition, temperature-controlled be brought about.

The Scaffold can also have woven filaments made of a plastic. Such a scaffold can be advantageous with a die-cast or Produce extrusion process. The filaments can also be treated with an elastomer be coated.

The Wall thickness of the scaffold is less than a fifth, preferably less than one tenth of the outer diameter of the scaffold in the supporting state. A Low wall thickness has the advantage that the tracheostoma is kept small can be. The smaller the tracheostomy, the faster and easier better the opening heals after removal of the tracheostoma placeholder. In an advantageous Embodiment, the tracheostomy placeholder has two concentric Scaffolding on, an outer scaffold being permanent or semipermanently placed in the trachea opening is and an inner scaffold to it is provided, pulled out at certain intervals from the outer scaffold and to be cleaned.

Of the procedural part The task is performed by a tracheotomy procedure with the measure of Claim 33 solved. For this purpose, a first Trachea opening (tracheostoma) and then a diameter expandable tracheostoma wildcard placed in the trachea opening.

advantageous Embodiments of the tracheotomy procedure are the subject of dependent claims 34 to 37th

The Trachea opening can be stung with a needle. The tracheal opening is preferred cut a knife, scalpel or trocar. By cutting prevents the tissue from tearing at the tracheostoma, causing the tissue heals worse and larger or thicker scars develop can. The section for the preparation of the trachea opening should be transverse to the trachea be set. This is anatomically advantageous, since the cartilage rings, which the trachea surrounded, oriented in this direction.

at Need the tracheal opening before the Placing the Tracheostomy Placeholder with a rigid or diameter-divisible instrument, for example, a balloon dilator.

A solution The device-related part of the task consists in a device for the introduction a tracheostoma wildcard with the features of claim 38th

The device comprises a cutting instrument, on the shaft of which the tracheostoma placeholder can be placed, and a covering sleeve, which is placed on the shaft via a tracheosto placed there ma placeholder is relocatable.

The Device can be used to puncture a trachea or to produce a Tracheotomy or thereafter introduced into the resulting trachea opening. After a bronchioscopic control of the position of the device becomes the cover sleeve withdrawn, leaving one under the cover sleeve placed tracheostoma placeholder from a starting position in an enlarged diameter support state expands and set up the fixing. Subsequently, will the device for insertion of the tracheostomy spacer pulled out of the opening again. By the Use of this device for introducing a tracheostoma wildcard is a minimally invasive and fast placement of the placeholder allows.

advantageous embodiments and further developments of the device are the subject of the dependent claims 39 to 51st

The Cutting instrument may have a conical tip. A Such a tip expands the tracheostoma advantageous when inserting of the device.

The Scheidinstrument has a channel for a guide wire. The guidewire is made before making the tracheotomy percutaneously in the trachea introduced and then plugged or threaded into the channel. Consequently is the accuracy of placement of the tracheotomy and the tracheostomy insert higher.

The Cutting instrument may include a needle. With the needle, the windpipe be dotted favorably.

The Cutting instrument includes supplementary or alternatively a knife, a scalpel or a trocar. With these Instruments can be an advantageous horizontal tracheotomy getting produced.

On the cover sleeve a cuff can be arranged. Such a cuff is ring-shaped and inflatable. If necessary, the tracheostomy can be widened with the cuff become.

Of the Shank has a magazine section. In the magazine section is the diameter of the shaft tapers, leaving a tracheostomy placeholder placed at this point and during of the insertion process can be fixed in position in the initial state.

Farther the shaft has a guide section on, the advantage of the displacement of the cover sleeve on the shaft allows.

Of the Shank and the cover sleeve can bent accomplished be. This will be an adaptation to the anatomical conditions achieved and facilitates the insertion of a tracheostomy spacer. Appropriately, are the shaft and the cover sleeve along the longitudinal axis curved.

The Device is adapted in cross section to a tracheal opening. The cross section is therefore not inevitable circular trained but may also be oval and / or a dent and / or bulge.

It is a gripping surface intended. This allows the safe manual grasping of the device. The gripping surface points a surface structure.

The Device further comprises a security element. So it is intended that the cutting instrument is retractable into a housing. This will Minimizes the risk of injury and the risk of mishaps. To retract the cutting instrument actuation is provided, which is an actuator, for example in the form of a push button, at the free end in the Near the gripping surface includes.

Further may be at the tip of the cutting instrument or at the cover sleeve Be abutment, which prevents the device over a defined depth out into the trachea can be inserted. By re-storage is advantageous to prevent injury to the rear wall of the trachea.

Farther is an instrument for removing and / or reinserting the tracheostomy insert intended. The instrument can be inserted into the scaffold. Gripping elements, preferably in the longitudinal direction of the instrument are spread, then access at least one Section of the scaffold and / or a fixing element. The tracheostoma wildcard is then for example, in length pulled and reduced in diameter. In this way it dissolves the tracheostoma placeholder from the surrounding tissue and can with The instrument is pulled out of the trachea opening become. This procedure can be applied in reverse order to replace the tracheostoma insert in the trachea opening.

The Invention will be described below with reference to the drawings embodiments explained in more detail. It demonstrate:

1 a schematic section through the upper body of a human;

2 a tracheostoma placeholder in cross section;

3 the tracheostoma placeholder in a side view from the front;

4 a valve unit in a side view;

5 the valve unit in cross section along the line VV in 4 ; and

6 a device for the introduction of the tracheostoma spacer in cross section, wherein the tracheostoma spacer is placed under the cover sleeve.

Same or similar Features in the drawings are provided with identical reference numerals.

In 1 is a schematic section through the upper body 1 a patient 2 shown. In the area of the neck 3 there is the trachea 4 in front of the esophagus 5 and the spine 6 , To the patient 2 To facilitate breathing was made a percutaneous tracheotomy, in which an opening of the trachea 4 was created through the skin, called a tracheostoma 7 referred to as. To prevent the tracheostoma 7 quickly reseals, is an inventive tracheostomy placeholder 8th in the tracheostoma 7 placed.

In the 2 and 3 is the tracheostoma wildcard according to the invention 8th shown in more detail. The tracheostomy placeholder 8th has a tubular scaffold 9 on. The scaffold 9 is self-expanding from an initial state A (shown in phantom) to an enlarged diameter support state S. To the scaffold 9 in length L to be able to adjust, a self-adjusting scaffold geometry is provided.

The scaffold 9 is from a sheath 10 surrounded, which consists of a polymer. The sheath facilitates insertion and removal of the tracheostoma stent 8th and prevents injuries to the adjacent tissue 11 (see. 1 ) in front. Furthermore, the sheath contains 10 Pharmaceutical agents that are anti-inflammatory and serve the defense against bacteria.

The scaffold 9 has a circular cross-section and can then be cut very easily from a tubular semi-finished product. The scaffold 9 consists of non-illustrated struts in the form of filaments. The filaments consist of a shape memory alloy, in particular of a nickel-titanium alloy, which is also referred to as Nitinol.

To the tracheostoma 7 (see. 1 ) as small as possible, is the wall thickness WD of the scaffold 9 less than one tenth (1/10) of the outside diameter AD of the scaffold 9 in support state S.

At both ends 12 . 13 of the scaffold 9 are fixing elements 14 - 17 provided that a positional fixation of the tracheostomy placeholder 8th in the trachea 4 enable. The fixing elements 14 - 17 are in the support state S at an angle β of 80 ° to 100 ° bent over the outer circumference A of the scaffold 9 in front. It's at every end 12 ; 13 two fixing elements 14 . 15 ; 16 . 17 provided, which are arranged opposite to each other. The fixing elements 14 . 15 one end 12 are opposite the fixing elements 16 . 17 the other end 13 at a right angle α about the central longitudinal axis MLA of the scaffold 9 arranged rotated. To the handling of the Tracheostoma Platzhalter 8th to improve the input and run, have the fixing elements 14 - 17 annular recesses 19 - 22 on grasping the tracheostomy insert 8th , For example, with a hook-shaped instrument easier. The fixing elements 14 - 17 have edges atraumatic edges 23 on, which are rounded and polished.

On the inside 24 of the scaffold 9 is also a coupling element 25 provided in the form of a circumferential groove. The coupling element 25 forms an abutment for fixing a in the scaffold 9 inserted valve unit or a moistener or a pushed through hose, which is also referred to as a catheter.

A valve unit 26 is exemplary in the 4 and 5 shown. The valve unit 26 has a sleeve-shaped middle section 27 on, at the two beak-shaped lips 28 . 29 connect. Every lip 28 . 29 has a flat section 30 on, which is thin and flexible, allowing breathing air in the direction of R with very little resistance through the valve unit 26 can inhale. In the opposite direction is the valve unit 26 closed during exhalation. Another advantage of this valve unit 26 is that also hoses and similar items in direction R through the valve unit 26 can be introduced. On the outer peripheral surface 31 of the sleeve-shaped portion 27 is a coupling element 32 arranged in the form of a rotating spring. The end faces the valve unit 26 a circumferential collar 33 on.

In the 6 is a device 34 for the introduction of a tracheostoma wildcard 35 shown. This device 34 is a rigid surgical instrument that has an internal cutter instrument 36 in the form of a trocar 37 and an outer cover sleeve 38 having. The trocar 37 has two razor-sharp edges 39 . 40 with which a trachea opening can be created by piercing. The trocar 37 is on a shaft 41 arranged. Behind the trocar 37 There is a diameter tapered magazine section 42 on which a tracheostomy placeholder 35 is placed. This is followed by a diameter-widened guide section 43 at. The cover sleeve 38 is sliding on the guide section 43 of the shaft 41 displaced and is introduced via the tracheostomy placeholder 35 pushed and keeps this in the initial state. End of the shaft 41 a gripping surface 44 on.

To widen the tracheostoma is circumferentially on the cover 38 a cuff 45 arranged, which can be filled with a fluid. This is indicated by the cuff 45 suitable connection elements 46 for a hose 47 on.

With the device 34 for the introduction of the tracheostoma wildcard 35 becomes the placement of the tracheostoma wildcard 35 much easier and faster. First, the trachea must be punctured only with small diameter. Subsequently, the device 34 introduced and the correct position in the tracheostomy bronchioscopically controlled. Then the cover sleeve 38 withdrawn and the tracheostomy placeholder 35 expands, with the fixation set up. Finally, the device needs 34 only be pulled out of the opening again.

With the tracheostoma wildcard according to the invention 8th . 35 a minimally invasive tracheostomy is possible. Due to the radially acting forces during the self-expansion of the tracheostoma spacer 8th . 35 becomes an expansion of the tracheostoma 7 causes, so that can be dispensed with further aids in the rule. The tracheostoma has a small diameter and heals after removal of the tracheostoma placeholder 8th . 35 in no time.

1

upper body

2

patient

3

neck

4

windpipe

5

esophagus

6

spinal column

7

tracheostomy

8th

Tracheostomy placeholder

9

scaffold

10

jacket

11

tissue

12

End of v. 9

13

End of v. 9

14

fixing

15

fixing

16

fixing

17

fixing

19

recess

20

recess

21

recess

22

recess

23

edge

24

Inside v. 9

25

coupling element

26

valve unit

27

sleeve-shaped section v. 26

28

lip

29

lip

30

plane section v. 28 . 29

31

peripheral surface

32

coupling element

33

collar

34

contraption

35

Tracheostomy placeholder

36

cutting instrument

37

trocar

38

cover sleeve

39

Edge v. 37

40

Edge v. 37

41

shaft

42

Magazine section

43

guide section

44

Greifffläche

45

Cuff

46

connection elements

47

tube

A

outer periphery

AD

outer diameter

L

length

MLA

central longitudinal axis

R

direction

WD

wall thickness

α

right angle

β

angle

Claims (51)

Tracheostoma placeholder with a tubular scaffold ( 9 ), characterized in that the scaffold ( 9 ) is expandable from an initial state (A) into an enlarged diameter support state (S) and end a fixing element ( 14 - 17 ) having. Tracheostoma wildcard according to claim 1, characterized in that the scaffold ( 9 ) is self-expanding from an initial state (A) to an enlarged diameter supporting state (S). Tracheostomy-placeholder according to claim 1 or 2, characterized in that the length (L) of the scaffold ( 9 ) is adjustable. Tracheostomy placeholder according to one of claims 1 to 3, characterized in that the fixing element ( 14 - 17 ) atraumatic edges ( 23 ) having. Tracheostoma placeholder according to one of claims 1 to 4, characterized in that the fixing element ( 14 - 17 ) in the support state (S) transversely to the central longitudinal axis (MLA) of the scaffold ( 9 ) over the outer circumference (A) of the scaffold ( 9 ) protrudes. Tracheostoma placeholder according to one of claims 1 to 5, characterized in that at one end ( 12 ; 13 ) of the scaffold ( 9 ) two fixing elements ( 14 . 15 ; 16 . 17 ) are provided. Tracheostoma placeholder according to claim 6, characterized in that the fixing elements ( 14 . 15 ; 16 . 17 ) of an end ( 12 ; 13 ) are arranged opposite one another. Tracheostomy placeholder according to one of claims 1 to 7, characterized in that at both ends ( 12 ; 13 ) of the scaffold ( 9 ) Fixing elements ( 14 . 15 ; 16 . 17 ) are provided. Tracheostomy placeholder according to claim 8, characterized in that the fixing elements ( 14 . 15 ) of an end ( 12 ) relative to the fixing elements ( 16 . 17 ) of the other end ( 13 ) by a right angle (α) about the central longitudinal axis (MLA) of the scaffold ( 9 ) are arranged rotated. Tracheostomy placeholder according to one of claims 1 to 9, characterized in that a fixing element ( 14 - 17 ) a recess ( 19 - 22 ) having. Tracheostoma placeholder according to one of claims 1 to 10, characterized in that the supporting framework ( 9 ) Has hose guide elements. Tracheostomy placeholder according to claim 11, characterized in that the tube guide elements via one end ( 12 . 13 ) of the scaffold ( 9 ). Tracheostomy insert according to claim 11 or 12, characterized in that the hose guide elements are curved or have a paragraph. Tracheostoma placeholder according to one of claims 1 to 13, characterized in that the scaffold ( 9 ) is associated with a valve unit. Tracheostoma placeholder according to one of claims 1 to 13, characterized in that the scaffold ( 9 ) is associated with a humidifier. Tracheostoma placeholder according to one of claims 1 to 15, characterized in that a coupling element ( 25 ) for fixing in the scaffold ( 9 ) carried or inserted objects is provided. Tracheostoma wildcard according to one of claims 1 to 16, characterized in that the supporting framework ( 9 ) a sheath ( 10 ) having. Tracheostomy spacer according to claim 17, characterized in that the sheath ( 10 ) consists of a polymer. Tracheostomy insert according to claim 17 or 18, characterized in that the sheath ( 10 ) contains active pharmaceutical ingredients. Tracheostomy-placeholder according to one of claims 1 to 19, characterized in that reservoir is provided which has an opening the peripheral side of the scaffold has. Tracheostomy-placeholder according to one of claims 1 to 20, characterized in that a channel is provided, the one Having end on the peripheral side of the scaffold. Tracheostomy placeholder according to one of claims 1 to 21, characterized in that the supporting framework ( 9 ) has an annular cross-section. Tracheostomy-placeholder according to one of claims 1 to 21, characterized in that the support frame has an oval cross-section having. Tracheostomy-placeholder according to one of claims 1 to 23, characterized in that the scaffold in cross-section a dent having. Tracheostomy-placeholder according to one of claims 1 to 24, characterized in that the support frame has a bulge in cross section. Tracheostoma wildcard according to one of claims 1 to 25, characterized in that the supporting framework ( 9 ) Has struts of filaments. Tracheostomy placeholder according to claim 26, characterized characterized in that the filaments consist of a metal. Tracheostomy placeholder according to claim 27, characterized in that the filaments consist of a shape memory alloy. Tracheostoma wildcard according to one of claims 1 to 25, characterized in that the supporting framework ( 9 ) comprises woven plastic filaments. Tracheostomy-placeholder according to one of claims 1 to 29, characterized in that the filaments with an elastomer are coated. Tracheostoma placeholder according to one of claims 1 to 30, characterized in that the wall thickness (WD) of the scaffold (WD) 9 ) is less than one-fifth (1/5) of the outer diameter (AD) in the support state (S). Tracheostoma placeholder according to one of claims 1 to 30, characterized in that the wall thickness (WD) of the scaffold (WD) 9 ) is less than one-tenth (1/10) of the outer diameter (AD) in the support state (S). Tracheotomy procedure consisting of the following steps: Making a trachea opening and Placing a diameter expandable tracheostoma spacer in the trachea opening. Tracheostomy method according to claim 33, characterized characterized in that the tracheal opening with a needle is made. Tracheostomy method according to claim 33, characterized characterized in that the tracheal opening with a knife, scalpel cut or stung with a trocar becomes. Tracheostomy method according to claim 35, characterized characterized in that the cross-section for making the tracheal opening to the trachea is set. Tracheotomy procedure according to one of claims 33 to 36, characterized in that the tracheal opening prior to placing the Tracheostoma placeholder with a rigid or in diameter widening instrument is widened. Device for introducing a tracheostoma spacer ( 35 ) according to any one of the preceding claims in a tracheostoma with a cutting instrument ( 36 ), on whose shaft ( 41 ) the tracheostoma placeholder ( 35 ) is placeable, and a cover sleeve ( 38 ), which on the shaft ( 41 ) via a tracheostoma placeholder ( 35 ) is displaceable. Device according to claim 38, characterized in that the cutting instrument ( 36 ) has a conical tip. Device according to claim 38 or 39, characterized in that the cutting instrument ( 32 ) has a channel for a guide wire. Device according to one of claims 38 to 40, characterized in that the cutting instrument ( 36 ) comprises a needle. Device according to one of claims 38 to 41, characterized in that the cutting instrument ( 36 ) a knife, a scalpel or a trocar ( 37 ). Device according to one of claims 38 to 42, characterized in that on the cover sleeve ( 38 ) a cuff ( 45 ) is arranged. Device according to one of claims 38 to 43, characterized in that the shaft ( 35 ) a magazine section ( 36 ) having. Device according to one of claims 38 to 44, characterized in that the shaft ( 41 ) a guide section ( 43 ) having. Device according to one of claims 38 to 45, characterized that the shaft and the cover sleeve bent are. Device according to one of claims 38 to 46, characterized that the outer shape is in Cross-section is adapted to a trachea opening. Device according to one of claims 38 to 47, characterized in that a gripping surface ( 44 ) is provided. Device according to one of claims 38 to 48, characterized that a security element is provided. Device according to claim 49, characterized a security element is a housing. Device according to claim 49, characterized a security element is an abutment.