WO2002051323A1 - Foldable sleeve used as a channel for instruments for minimal invasive surgery - Google Patents

Abstract

The invention relates to an instrument sleeve for minimal invasive surgery. Said instrument sleeve has an adaptation element (1) on the proximal end and a sleeve (4) comprising a fold along its wall in the longitudinal direction, enabling the diameter of the sleeve to be reduced. Following the introduction of the instrument sleeve which surrounds the Veress needle with as small an outer diameter as possible, said Veress needle is removed and the sleeve is unfolded to the desired diameter, using a dilation trocar. The wall of the sleeve is watertight and gastight and has a slight resistance to the sliding friction between its surface, the body tissue and the material of the sleeve of the dilation trocar.

Description

Foldable instrument canal sleeve for minimally invasive surgery Introduction:

The invention relates to a sleeve serving as an instrument channel according to the preamble of claim 1. In minimally invasive surgery, it is first necessary to provide access for the rod-shaped instruments in order to be able to reach an operating area located inside the body. For this purpose, the tissue layers are usually penetrated with a trocar, which consists of a sleeve with a trocar mandrel arranged therein. The The standard outside diameter of the instruments to be inserted is 5 to 12 millimeters. The outer diameter of the trocar sleeves is therefore about 7 to 14 millimeters. Since these trocars are inserted without visual inspection, there is a risk of injury to blood vessels and internal organs, especially if they are adherent due to adhesions on the abdominal wall. Various instruments have been developed to reduce these fundamental risks. For example, visible trocars from the Endopath Optiview (registered trademark) product range from Ethicon, Ci. US. (Pat No. US 5,271,380; 5,685,820; 5,431,151; 6,007,481) the abdominal wall can be penetrated under visual control, but the penetration pressure is high due to the relatively large diameter of the trocars. Before inserting the visible trocars, a pneumoperitoneum with C02 gas is created with the help of a measuring needle in order to distance the internal organs from the abdominal wall. Inserting this needle, however, also harbors the risk of injury described above (description in Pat. No. DE 40 35 146 C2). Under the mechanistic notion that an injury with a smaller trocar in diameter was less serious, techniques were developed to replace a trocar sleeve initially inserted with a smaller one with a larger one (dilation set, see Pat. No. DE 198 14 576 AI) or by expanding the elastic wall of a tubular one Enlarge sleeve with a dilation trocar (see Pat. No. US-5,431,676-A). In Pat. No. DE 198 14 576 AI, the diameter of the sleeve is actively changed by movable structural elements in the wall of the sleeve with the aid of actuatable actuating means. However, since the basic risk of injury does not depend on the diameter of the trocar, this can only be minimized by visually controlled access through the abdominal wall. It is even the case that an intestinal injury caused by a small diameter instrument is very dangerous, since symptoms that indicate an injury only appear after days and the injury site is difficult to find. In Pat. No. DE 195 47 246 Cl an optical measuring needle is described with which the primary puncture can be done under sight. The diameter of this needle should correspond to that of the conventional measuring needle and should be able to be inserted with a correspondingly low penetration pressure. Since the outer diameter of this needle is about 3-4 millimeters, procedures are necessary to expand the diameter of this puncture channel in order to be able to insert the sleeves for the surgical instruments. Since the stretchable sleeves described above significantly increase the diameter of the measuring needle, with the handling being adversely affected, the thinnest possible sleeve is required. Problem:

The prior art as described in Pat. No. US 5,431,676-A

85 offers a complex construction with three

Wall layers. The inner wall layer consists of one

Braid made of plastic threads, with one

Increasing the diameter due to the design

Sleeve length shortened. The braid alone offers little

90 stability in the longitudinal axis, but ensures a good one

Sliding the dilatation trocars in the braid sleeve. Since this braid is not a closed wall, it is covered by a stretchable rubber tube, which represents the middle layer and additional stability in

95 of the longitudinal axis as well as water and gas tightness. This tube absorbs a large amount of energy in the stretching phase, which must be applied to enlarge its own diameter. Since that

Braid enveloping rubber tube with its outer surface in the

100 tissue slides poorly, this is with a smooth but due to the material not stretchable outer layer, which consists of a plastic sleeve and in the

Stretch phase bursts at predetermined breaking points, envelops. This results in a relatively large wall thickness of the sleeve

105 the wall structure from three different layers.

The sleeve according to the invention, on the other hand, is said to be variable in diameter by folding and unfolding its single thin wall and in diameter when folded be reduced so that this, with a Veressneadel im

110 Ideally, the needle can be inserted under sight and the outside diameter of the measuring needle is enlarged as little as possible in order to keep the penetration pressure in the tissue as low as possible. The sleeve should then be able to be unfolded with a commercially available blunt trocar,

115 whereby the process of unfolding the sleeve itself should require as little force as possible in order to be able to use the force used to the greatest possible extent to expand the tissue layers. This also contributes to better feedback of the actual penetration pressure

120 and thus to better controllability of the penetration process for the surgeon. The wall of the sleeve should be stable in the folded state, ie with a small inside diameter of the sleeve and during the unfolding process in the longitudinal axis

125 be protected against kinking. In the unfolded state, the sleeve is stabilized by the inserted trocar sleeve and must therefore no longer have any substantial inherent stability. The sliding friction force between the outer surface of the dilatation trocar and the inner

130 surface area of the sleeve and the outer surface area of the sleeve and the tissue to be penetrated should be as small as possible. After removing the trocar sleeve due to the tissue pressure, the sleeve should again be as small as possible due to the surrounding area 135 stretched tissues can be compressed and folded together. Thus, the puncture channel, the diameter of which corresponds to the outside diameter of the sleeve which lies around the measuring needle, is only temporarily stretched in the tissue of the abdominal wall for the time of the operation, which is a

140 represents a maximally atraumatic procedure, and thus returns to its starting position after the sleeve of the dilatation trocar has been removed. So only one branch canal with the diameter of the Veressnadel is partially sharply cut (Fascie and Peritoneum), respectively

145 bluntly penetrated (subcutis, preperitoneal adipose tissue) and then passively stretched, whereby the dilatation trocar does not come into direct contact with the surrounding tissue, as this passively expands the tissue by unfolding the sleeve. After removing the sleeve of the

150 dilation trocars, the sleeve wall is folded again by the surrounding tissue pressure, whereby the diameter of the sleeve is reduced again. Due to their elasticity, the previously stretched fabric layers return to their starting position and slide

155 on top of each other like a backdrop, which prevents scar herniation. Furthermore, the sleeve is to be fixed in an advantageous embodiment in the unfolded state by suitable shaping of the wall in the longitudinal axis. Troubleshooting:

The sleeve according to the invention can rule out the disadvantages mentioned above and meet the required properties. It consists of a hollow one

165 adaptation element, which serves for the adaptation of the sleeve to a Veress needle and a folded along the longitudinal axis thin and good in the tissue and against the metal or plastic gleitsamen plastic film with ^■ smooth surface. The film should be very thin and

170 undeveloped state are stabilized by the folds in the longitudinal axis, these stabilizing the dilatation trocar during the unfolding process in the longitudinal axis. Since only the folds have to be unfolded, there is only one for unfolding the sleeve itself

175 low force is required, and after removal of the trocar sleeve, the sleeve can fold back to a small outer diameter due to the tissue pressure. In order to be able to fix the sleeve in the tissue in the longitudinal axis in the unfolded state, one is

180 Version with shaped elements such as webs, which increase the circumference locally in the transverse axis. These webs only reach the outer lateral surface after the sleeve has been unfolded and, when folded, turn away from the outer lateral surface.

185 Description:

Foldable instrument channel sleeve consisting of a sleeve 4 with an adaptation element 1 attached to it

190 sealing membrane 2 and sealing valve 3. The adaptation element 1 is used for the reversible adaptation of the sleeve to a measuring needle and, if appropriate, for accommodating a valve element which, for example, consists of a sealing membrane 2 and a sealing valve 3

195 can, which seals the lumen of the sleeve 4 proximally from the environment for gases. The sleeve 4 is fixed to the tubular adaptation element 1 with an adequate diameter in order to be able to accommodate the corresponding dilatation trocars and tapers

200 then conical in order to then form a tube-like channel in a smaller diameter which tightly surrounds the Veressnadel. The wall of the sleeve 4 is folded to reduce the diameter in the longitudinal axis and can be deployed against low resistance. Preferably

205 a plastic film is used for the material of the sleeve. The pleating with kinks in the longitudinal axis stabilizes the sleeve before and during the unfolding process. The sleeve is preferably visually inspected with an optical measuring needle

210 abdomen introduced. After the insufflation of C02 gas via the measuring needle or the gap between the sleeve and the measuring cannula, the measuring needle is removed and then through a dilatation trocar, consisting of a blunt trocar mandrel 5 and a trocar sleeve 6 replaced.

215

Figure 1 shows a side view of the undeveloped

Sleeve with adaptation element 1 and sleeve 4.

Figure 2 shows a top view of the sleeve 4

Adaptation element 1 from proximal. 220 Figure 3 shows a side view of the partially unfolded

Sleeve 4 and the adaptation element 1. The dilation trocar, which consists of the trocar sleeve 6 and the trocar mandrel 7, is inserted.

Figure 4a shows a possible folding of the sleeve wall in 225 cross section.

FIG. 4b shows the wall cross section 4a in an enlargement.

Shaped elements 7, which extend transversely to the longitudinal axis of the sleeve, serve for the fixation of the in the unfolded state

Sleeve in the tissue in the longitudinal axis. 230 Figure 5 shows a side view of the fully deployed sleeve 4 with adaptation element 1. Der

Dilatation trocar consisting of the trocar sleeve 6 and the

Trocar mandrel 5 is fully inserted.

FIG. 6 shows a cross section through the trocar sleeve 6 of the 235 dilatation trocar and the unfolded sleeve.

Figure 7 shows a longitudinal section through the adaptation element

1 and the sleeve 4. In the adaptation element 1 is one

Sealing membrane 2 and a sealing valve 3 can be seen. Reference symbol list: 1 = adaptation element

2 = sealing membrane

3 = sealing valve

4 = sleeve

5 = trocar mandrel 6 = trocar sleeve

7 = form elements

Claims

claims: 240 1. As an instrument channel for minimally invasive surgery, a tubular sleeve with a variable inner diameter, characterized in that the sleeve 4 is fastened at the proximal end in a hollow adaptation element 1 and extends distally 245 tapered in diameter by folding the wall in the longitudinal axis and tapering proximally in this diameter, the sleeve being able to be expanded to a larger diameter with the aid of a dilatation trocar. 250 2. Instrument sleeve according to claim 1, characterized in that in the adaptation element 1 sealing elements are integrated, which seal the lumen of the sleeve against the proximal opening of the adaptation element. 255 3. Instrument sleeve according to claim 1, characterized in that the distal end of the sleeve over a short distance of a few millimeters has only the diameter of the Veressnadel and has no fold of the wall and optionally 260 is even conical in order to obtain a transition to the circumferential surface of the measuring needle with as little caliber jump as possible, and thus to avoid any step formation in the penetration pressure curve which impedes the operation sequence. This distal 265 Ende has a predetermined breaking point along its length, which tears open when stretched. 4. Instrument sleeve according to claim 1, 2 or 3, characterized in that a supply channel with valve for C02 gas is attached to the adaptation element 270, which allows the supply of CO 2 gas into the adaptation element or the sleeve distal to the sealing elements. 5. Instrument sleeve characterized by a two-part construction, with the Veressnadel first 275 a C-shaped unfolded sleeve which tightly surrounds the measuring needle and ends distally in an adaptation element with a larger diameter. After the primary puncture, the Veressnadel is removed and an instrument sleeve after 280 Claim 1, 2, 3 or 4, which can be folded in a space-saving manner in the longitudinal axis, pushed into the C-sleeve and then expanded, the C-sleeve only opening and, if necessary, together with the instrument sleeve at the end of the operation 285 interlocking of the two adaptation elements is removed. 6. Instrument sleeve according to one or more of the preceding claims, characterized in that the wall of the sleeve in the longitudinal direction 290 diameter reduction is folded and in one advantageous embodiment with a defined folding of the sleeve, the sleeve sections not forming the outer surface of the sleeve, for example, locally increasing shape elements which increase the outside diameter in the transverse direction Have 295, which only reach the outer surface of the jacket after unfolding and cause a fixation of the sleeve in the tissue in the longitudinal direction. After removing the trocar sleeve, the instrument sleeve is again pressed by the 300 surrounding tissue are folded together and the form elements are then no longer on the outer surface of the jacket. In this way, the instrument sleeve can be easily removed again in the folded state. 305 7. Sleeve according to one or more of the above claims, characterized in that the adaptation element can be reversibly adapted to a corresponding measuring needle.