WO2011077409A2

WO2011077409A2 - Forceps for percutaneous tracheostomy

Info

Publication number: WO2011077409A2
Application number: PCT/IB2010/056060
Authority: WO
Inventors: Carlo Alberto Bosi
Original assignee: X-Med S.R.L.
Priority date: 2009-12-24
Filing date: 2010-12-23
Publication date: 2011-06-30
Also published as: WO2011077409A3; ITMO20090314A1; IT1397093B1

Abstract

A forceps (1) for percutaneous tracheostomy, comprising at least one pair of arms (2a, 2b), each of which has, at a first end, a tip (3) designed to be inserted in a tracheal stoma to dilate it and, at the second end, grip means (4), the arms (2a, 2b) being pivoted in at least one fulcrum point (5) which is intermediate between the respective ends, and at least one seat (6) for the passage of at least one wire-like guiding element for the insertion of each one of the tips (3) in the tracheal stoma, the passage seat (6) comprising at least one (perimetrically closed) through cavity (7) which is associated with at least one (2a) of the arms (2a, 2b), whose inlet (8) for the wire-like element is associated with the tip (3) and whose outlet (9) is provided at a region which is intermediate between the first end and the second end of the at least one arm (2a).

Description

FORCEPS FOR PERCUTANEOUS TRACHEOSTOMY

Technical field

The present invention relates to a forceps for performing percutaneous tracheostomies.

Background Art

A tracheostomy is an operation that involves creating an opening of a stoma through the tracheal wall. This operation is necessary in some cases for treating "acute" pathologies, i.e. traumas, burns etc., but it is also used for treating chronic pathologies which flare up, for example chronic obstructive broncopathy, neurological syndromes and others.

A tracheostomy involves inserting a tracheal cannula in the opening made in the tracheal wall, which prevents the opening from closing up again and at the same time allows direct access to the trachea, thus allowing ventilation.

The critical step for inserting the tracheal cannula is the step involving the formation of an opening in the tracheal wall which is of sufficient size to accommodate the cannula.

To avoid surgical procedures for providing this opening, i.e. to reduce the use of incisions with a scalpel in the tissues which, starting from the skin, cover the trachea down to the opening in the trachea itself, different methods and associated devices have been offered to obtain a gradual and elastic dilation of the tissues starting from a small incision made in the tracheal wall.

In particular, in all these techniques, of which two pertain to the case addressed herein and shall be described hereinbelow, there is a first common step, i.e. the execution of the cutaneous incision at a space identified between the tracheal rings. At this incision, a needle is inserted until it perforates the inner wall of the trachea and accesses the tracheal cavity.

Slideably accommodated inside the needle is a flexible, wire-like guiding element, which is positioned inside the trachea and whose ultimate function is to guide the insertion of the cannula along the opening made by the needle.

A first known technique is named after the Canadian chest surgeon P. Ciaglia, who published his work titled "Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report" in which he proposed to perform a tracheal stoma using dilators of increasing size, guided by the wire-like guiding element which was previously positioned in the trachea. Subsequently this technique was modified by its inventor, who proposed using a single dilator of increasing size.

In any case, when the opening which is made reaches the desired dimensions, the surgeon proceeds to insert the cannula.

However, this type of tracheostomic method appears to be decidedly invasive, and, indeed, repeating the operations to insert several cannulae involves high risks of damage or laceration of the rear wall of the trachea that faces the opening which is created, which risks are due to the impact with the front part of the cannulae, which are generally sharp or tapered.

A second known technique is named after an anesthetist, W. M. Griggs, who published his work titled "A simple percutaneous tracheostomy technique", in which he suggested using a forceps with a curved end to dilate the trachea and to then be able to position the tracheotomic cannula.

As mentioned, the tracheotomy according to Griggs aims at overcoming the drawbacks of the first technique and involves the use of a metal forceps which, guided by the previously-positioned wire-like guiding element, dilates the trachea and the peritracheal tissues in parallel with the progress of these. In this case the risk of breaking a tracheal ring is minimal or nonexistent.

Griggs's forceps comprise two arms which are mutually pivoted in scissors' fashion at a region which is intermediate between the ends, thus giving rise to a first-class asymmetric lever system, i.e. the opening of the tips occurs in tandem with a dilation of the ends of the arms opposite to the tip, i.e. of the grip ends.

The tips of the arms of Griggs's forceps, particularly, are shaped in such a way that in the closed configuration a passage is formed between them for the wire-like guiding element.

Specifically, on each end there is a semi-channel which in the closed configuration is designed to lie alongside the other semi-channel which is defined in the other arm, thus forming a channel interposed between the arms, whose inlet for the wire-like element is arranged in proximity to the distal end of the tip and whose outlet is associated with a rear region of the arm, i.e. in a region which is intermediate between the tip and the fulcrum point between the two arms.

The operation is carried out as follows: the space between the 2nd and the 3rd tracheal ring is identified and the local anesthesia is performed; then the trachea is penetrated with a cannula needle, verifying that it is correctly positioned with the free aspiration of air. Through the cannula needle a wire-like guiding element, for example made of metal, is introduced which is caudally directed toward the end of the bronchial tree, and it is verified that the wire slides freely, which indicates correct positioning. Then a radial incision of approximately four millimeters is performed in the skin and subcutaneously; it should be pointed out that up to this point there is no difference from Ciaglia's techniques, which in turn is an application of Seldinger's technique for positioning a wire-like guiding element, a technique used in various sectors of medicine.

At this point, guided by the previously-positioned wire, the first retractor is introduced in the trachea, and then the metal forceps is introduced which must remain in the closed configuration during all of the insertion step so as to keep the wire-like element interposed between the two semi-cavities and with which the tracheal rings will be operated on so as to be dilated, thus automatically forming the tracheal stoma. Lastly, once the desired size of the stoma has been obtained, the tracheal cannula provided with a cap is introduced for the seal. The tracheotomy is performed in a single step without using rigid dilators.

Furthermore, among the advantages of this technique and the use of this device, first and foremost the fact must be pointed out that it is very simple and quick to perform, it requires only one operator, and the learning curve, for an operator who already performs dilative tracheostomies with any technique is practically immediate.

The dilation of the trachea and of the peritracheal tissues, moreover, occurs by means of a progressive dilation. Thanks to the action mechanism illustrated previously, this technique reduces the risk of bleeding to the minimum and decreases the risk of breaking the tracheal rings.

In no way is it possible to injure the rear wall of the trachea and this eliminates the possibility of causing a subcutaneous emphysema or, worse, a pneumothorax.

What is more, it is not necessary to extubate and reintubate the patient, as everything is done using the tube already in position, and verification of the patient's airways is continuous and complete.

Lastly, the time required for performing the procedure is so short, from three to five minutes, that this technique can certainly also be used for emergency ventilation and tracheotomies, dramatic situations where having a method that is simple, safe and extremely fast means changing the patient's prognosis.

However, this second device and operation method are not without drawbacks either, among which is the fact that the above-mentioned forceps, in providing the two semi-cavities which in the closed-tips configuration form the passage for the wire-like element, would not prevent the wire-like guiding element from leaving its seat in the event of an incorrect movement of the forceps or of the opening of the tips, intentionally or accidentally, during insertion, forcing the operator to repeat the entire procedure.

Moreover, given the nature of the lever system underlying Griggs' forceps, the maneuver is often traumatic for the tissues during the procedure, especially because of the impossibility of controlling the force that operates on the stoma and the impossibility of controlling the dimensions of the stoma which it is intended to obtain, since the distinctive characteristic of this forceps lies in the fact that the direction of opening of the tips is parallel to the direction of opening of the grips and, therefore, of the operator's hand.

In addition to this, associated with this type of operation is the risk, though minimal, of infection since the forceps is reusable and thus subject to sterilization, which is not always effective in preventing certain risks. Disclosure of the invention

The aim of the present invention is to eliminate the above-mentioned drawbacks of the known art, while maintaining all its advantages listed above, by providing a forceps for percutaneous tracheostomy which makes it possible for the wire-like guiding element to safely and effectively slide and be retained during all steps of insertion by preventing any detachment, intentional or accidental, of the wire-like element from the forceps itself.

Within this aim, an object of the invention is to prevent accidental excessive dilations of the applied tracheal stoma, by making the forceps safer and better controlled in every step of the operation.

Another object of the invention is to make the use of the instruments for percutaneous tracheostomy operations safer and more hygienic.

Another object of the present invention is to provide a forceps that is easy and practical to implement, safe to use and effective in operation, and has relatively low costs.

This aim and these objects, as well as others which will become more apparent hereinafter, are achieved by the present forceps for percutaneous tracheostomy, comprising at least one pair of arms, each of which has, at a first end, a tip designed to be inserted in a tracheal stoma to dilate it and, at the second end, grip means, said arms being pivoted in at least one fulcrum point which is intermediate between the respective ends, at least one seat for the passage of at least one wire-like guiding element for the insertion of each one of said tips in said tracheal stoma, characterized in that said passage seat comprises at least one (perimetrically closed) through cavity which is associated with at least one of said arms and whose inlet for said wire-like element is associated with said tip and whose outlet is provided at a region which is intermediate between said first end and said second end of said at least one arm.

Brief description of the drawings

Further characteristics and advantages of the present invention will become better apparent from the following detailed description of a preferred, but not exclusive, embodiment of a forceps for percutaneous tracheotomy, illustrated by way of non-limiting example in the accompanying drawings, wherein:

Figure 1 is a top view of a forceps according to the invention;

Figure 2 is a side elevation view of Figure 1 ;

Figure 3 is a perspective view of an arm of the forceps, according to the invention;

Figure 4 is a bottom view of Figure 3;

Figure 5 is a sectional view taken along the line IV-IV of Figure 4 of a detail of Figure 4;

Figure 6 is an enlarged-scale view of a detail of Figure 3.

Ways of carrying out the invention

With reference to the figures, the reference numeral 1 generally indicates a forceps for percutaneous tracheostomy.

The forceps 1 comprises at least one pair of arms 2a, 2b, each of which has, at a first end, a tip 3 designed to be inserted in a tracheal stoma to dilate it and, at the second end, grip means 4, for example a ring for inserting an operator's finger.

The arms 2a, 2b are pivoted in at least one fulcrum point 5 which is intermediate between the respective ends.

The forceps 1 , furthermore, comprises at least one seat 6 for the passage of at least one wire-like guiding element for the insertion of each one of the tips 3 in the tracheal stoma.

In particular, the passage seat 6 comprises at least one through cavity

7, which is perimetrically closed and is associated with at least the arm 2a of the arms 2a, 2b and whose inlet 8 for insertion of the wire-like element is associated with the tip 3 of the arm 2a and whose outlet 9 is provided at a region which is intermediate between the first end and the second end of the arm 2a.

In particular, the cavity 7 is perimetrically closed since its perimetric walls are provided inside the arm itself; the cavity 7 is, therefore, provided inside the at least one arm 2a.

Advantageously, the outlet 9 is arranged at a region which is intermediate between the tip 3 and the fulcrum point 5, while the inlet 8 is associated with the penetrating front wall of the tip 3.

Furthermore, the longitudinal axis of the cavity 7 can be substantially parallel to the longitudinal axis of the portion of the arm 2 in proximity to the tip 3.

The arms 2a, 2b are shaped mutually symmetrically with respect to a plane of symmetry that passes through the fulcrum point 5.

The tips 3 are mutually movable between at least one open configuration, in which they are mutually spaced, and at least one closure configuration, in which they are mutually closer and arranged substantially parallel to the plane of symmetry.

The arms 2a, 2b, furthermore, form a first-class symmetric lever system and, therefore, the tips 3 move mutually apart when the grip means 4 are moved closer by compression, and vice versa.

The forceps 1, furthermore, comprises at least one adjustable abutment element 10 which is associated with at least the arm 2a of the arms 2a, 2b and is adapted to abut against the other arm 2b to adjust the maximum mutual stroke of the tips 3.

In particular, the adjustment of the maximum opening of the tips is advantageous for the purpose of preventing possible damage to the trachea, for example owing to an excessive opening of the tracheal stoma.

The abutment element 10 comprises at least one threaded nut 11 which is associated, by means of a pin 12 which is also threaded (and is integrally associated with the arm itself, for example made as one piece with it), with one of the arms 2a, 2b in the region designed to be interposed between the two arms and arranged between the grip means 4 and the fulcrum point 5 of the arm.

In the preferred embodiment shown in the figures the abutment element 10 is associated with the same arm 2a with which the cavity 7 is associated, but different configurations are not excluded, in which the cavity 7 is associated with the arm 2b opposite the arm 2a with which the abutment element 10 is associated.

The screwing rototranslation of the nut 11 on the threaded pin 12 is such as to increase the mutual stroke between the tips 3 of the arms 2a, 2b and, vice versa, the unscrewing rototranslation decreases the maximum mutual stroke between the tips 3.

However, different and equivalent embodiments of the abutment element 10 are not excluded.

Furthermore, the forceps 1 comprises means 13 for the return of the arms 2a, 2b from the open configuration to the closed configuration of the tips 3.

The return means 13, in particular, are of the elastic type and comprise at least one compression spring, for example of the leaf type or other equivalent type, which is interposed between the arms 2a, 2b, for example in the area thereof which is interposed between the grip means 4 and the fulcrum point 5. The compression action for opening the tips 3 contrasts for example the elastic return means 13; therefore, the return means 13 are such as to mutually reopen the grip means 4 once the compression action applied by the operator has ended and, consequently, close the tips 3 of the forceps 1 again.

Advantageously, each one of the first ends and, therefore, each tip 3 has a substantially curved shape along its longitudinal axis.

In particular, each tip 3 is curved with respect to the longitudinal extension of each arm 2a, 2b by at least an angle that is substantially equal to 90°.

Furthermore, the tips 3 have rounded edges, so as to prevent any damage to the tracheal tissue.

Advantageously, the forceps 1 comprises at least one covering 14, at least of the area designed to be gripped, i.e., of the grip means 4, which is made of at least one material of the single-use type, for example taken from the group comprising PVC, PP, PE. The presence of this covering ensures that the forceps 1 is used in accordance with the single-use methodology, with consequent sterility and hygiene of the forceps itself and the operations to be performed with it.

The method of performing a percutaneous tracheostomy by means of the forceps 1 is usually conducted under local or general anesthesia.

A first step of the tracheostomy method comprises the step of locating the space comprised between the second and third tracheal rings and penetrating the trachea with a cannula needle, for example of caliber 16 G, ascertaining the correct positioning of the cannula needle with the free aspiration of air.

Through the cannula needle a wire-like element, called a wire guide, is then introduced and is caudally directed toward the end of the bronchial tree, and it is verified that the wire guide can slide freely, which indicates correct positioning. The operator proceeds with the step of making a radial incision in the skin and subcutaneously, for example approximately 4 millimeters in length, at the cannula needle insertion hole.

A second step of the method comprises the additional step of introducing into the trachea, guided by the previously-positioned wire-like element, the forceps 1 with which to operate on the tracheal rings so as to dilate them thus automatically forming the tracheal stoma.

In particular, the wire-like element is inserted in the inlet 8 and, by sliding inside the cavity 7, exits from the outlet 9 thus guiding the tips 3 between the pre-selected tracheal rings and thus permitting their dilation by means of compression of the grips (and consequent dilation of the tips 3).

In particular, the cavity 7 keeps the wire guide firmly inside it even during the active step of dilating the tips 3, the wire-like element thus remaining substantially associated with one of the arms 2a of the forceps 1 during all operations in which the forceps is used.

Furthermore, the method according to the invention can include, before the step of introducing the tips 3 in the trachea, the additional step of studying the maximum dilation that it is possible to impart to the patient's tracheal rings, since this can vary according to the pathology, dimensions and the age of the patient.

Subsequent to this study step it is possible to proceed with the step of adjusting, by means of the abutment element 10, the maximum reciprocal stroke of the tips 3 in order to prevent excessive lacerations of the patient's trachea.

Lastly, the method according to the invention comprises the third step of removing the tips from the previously-dilated tracheal stoma and inserting the tracheal cannula provided with a cap for the seal in the dilated stoma.

In practice it has been found that the invention described achieves the intended objects and in particular attention is drawn to the fact that the forceps for percutaneous tracheostomy, according to the invention, by means of the through cavity which is provided in one of the arms thereof makes it possible for the wire-like guiding element to safely and effectively slide and be retained during all steps of insertion by preventing any detachment, intentional or accidental, of the wire-like element from the forceps itself.

Furthermore, the forceps according to the invention, by providing a first-class symmetric lever system which thus enables the opening of the tips of the forceps upon a compression of the grip region, as well as the ability to limit the reciprocal stroke of the tips, makes it possible to prevent accidental excessive dilations of the tracheal stoma applied, thus making the forceps safer and better controlled at every step of the operation. Furthermore, specifying the insertion of single-use materials in the constitution of the forceps enables a better safety and hygiene in the use of the instrument for percutaneous tracheostomy operations.

The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims.

Moreover, all the details may be substituted by other, technically equivalent elements.

In practice the materials employed, as well as the contingent dimensions and shapes, may be any according to requirements, without for this reason leaving the scope of protection of the appended claims.

The disclosures in Italian Patent Application No. MO2009A000314 from which this application claims priority are incorporated herein by reference.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

1. A forceps (1) for percutaneous tracheostomy, comprising at least one pair of arms (2a, 2b), each of which has, at a first end, a tip (3) designed to be inserted in a tracheal stoma to dilate it and, at the second end, grip means (4), said arms (2a, 2b) being pivoted in at least one fulcrum point (5) which is intermediate between the respective ends, at least one seat (6) for the passage of at least one wire-like guiding element for the insertion of each one of said tips (3) in said tracheal stoma, characterized in that said passage seat (6) comprises at least one (perimetrically closed) through cavity (7) which is associated with at least one (2a) of said arms (2a, 2b), whose inlet (8) for said wire-like element is associated at said tip (3) and whose outlet (9) is provided at a region which is intermediate between said first end and said second end of said at least one arm (2a).

2. The forceps (1) according to claim 1 , characterized in that said arms (2a, 2b) are mutually symmetrical with respect to a plane of symmetry that passes through the fulcrum point (5), said tips (3) being mutually movable between at least one open configuration, in which they are mutually spaced, and at least one closure configuration, in which they are mutually closer and arranged substantially parallel to said plane of symmetry; said arms (2a, 2b) forming a first-class symmetric lever system, said tips (3) of said arms (2a, 2b) moving mutually apart when said grip means (4) are moved closer by compression.

3. The forceps (1) according to one or more of the preceding claims, characterized in that it comprises at least one adjustable abutment element (10), which is associated with at least one (2a) of said arms (2a, 2b) and is adapted to abut against the other one (2b) of said arms (2a, 2b) to adjust the maximum mutual stroke of said tips (3).

4. The forceps (1) according to one or more of the preceding claims, characterized in that it comprises means (13) for the return of said arms (2a, 2b) from said open configuration to said closed configuration.

5. The forceps (1) according to one or more of the preceding claims, characterized in that each one of said first ends has a substantially curved shape.