DE102011054263A1 - Sleeve for producing automatic vasoligation system, has hollow cylinder with two ends, where former end has automatic curvature - Google Patents

Abstract

The sleeve (1) has a hollow cylinder with two ends (2,3), where the former end has an automatic curvature (4). The curvature is formed such that the former end has two mutually alternating projections (5A,5B) and recesses (6A,6B). The sleeve has a permanently plastically deformable region or consists of permanently plastically deformable material. An independent claim is included for an applicator for a sleeve.

Description

introduction

The invention relates to a sleeve for the production of atraumatic vessel ligatures and to a system for producing vessel ligatures comprising such a sleeve. In particular, the invention relates to a system which is easy to handle, inexpensive and robust, and which is suitable for minimally invasive surgery.

State of the art and disadvantages

The conventional supply (sealing) of vessels is done by ligature. In this case, a thread (resorbable or not) is guided around the vessel and tightly knotted. Depending on the vessel size and structure, multiple other techniques, such as e.g. Electrocoagulation, used. In particular vessels in the soft tissues (skin, subcutaneous adipose tissue and musculature) can always be electrocoagulated. In other areas, such as Due to the large diameter and the fragile structure of the pulmonary vessels and the associated limited tear strength of the tissue, two techniques have found wide and reliable application: ligature in open surgery and mechanical stapling in metal-assisted lung resections.

In the latter method, after the freeing of the vessel, a mechanical suture device ("stacker") is placed so that the structure to be supplied lies between the two active branches of the device. By closing the branches both the sealing of the vessel with the corresponding brackets as well as the simultaneous transection of the same takes place.

• – das Einbringen des Gerätes in der gewünschten Position ist oft problematisch (z.B. schwer zugängliche Gefäße, kleine Zugangsöffnung);
• – kleine Gefäße können bei Einbringen des Staplers verletzt werden;
• – „Misfireing“: es kommt zu keiner Versiegelung durch die Klammern, das Gefäß wurde aber bereits durchgetrennt. Dies ist eine extrem seltene, trotzdem sehr gefürchtete Komplikation;
• – die Stapler-Geräte und die Klammermagazine sind sehr kostenintensiv.

This method, although reliable and fast, has the following disadvantages:

• - The introduction of the device in the desired position is often problematic (eg, difficult to access vessels, small access opening);
• - small vessels may be injured when the truck is brought in;
• - "Misfireing": there is no sealing through the brackets, but the vessel has already been severed. This is an extremely rare but very dreaded complication;
• - The stacker devices and the staple magazines are very costly.

An ideal solution would allow the supply of all of the above vessels in a variety of situations with ligatures. Especially in the field of minimally invasive surgery, this is currently hardly possible. Existing knot techniques are laborious and ligature of vessels unreliable. The problem with the known knotting techniques is also the fact that the compressive force with which the vessel is clamped (ligated), is difficult to adjust and largely depends on the experience of the surgeon. Although forklifts allow adjustment of the pressure force, they do not provide any feedback to the surgeon, so that in this case too "blind" work is required.

Object of the invention and solution

The object of the invention is therefore to provide a device which is suitable for the production of ligatures, and which avoids the aforementioned disadvantages of the prior art.

In particular, the device should be simple, robust and inexpensive, and allow a good adjustability of the ligature pressure. The device should be usable regardless of the diameter or structure of the vessel.

The object is achieved by a device according to the main claim. Further embodiments can be found in the subclaims and the figures and the corresponding description.

description

The system according to the invention presented below offers the possibility of ligating vessels, irrespective of their diameter, position and structure. The core of the system represents the "thread safety cylinder", which serves as a replacement for the conventional node.

• 1. den Fadenabsicherungszylinder (in zwei Größen, „S“ – small und „L“ – large),
• 2. den Fadenfänger,
• 3. die Applikations- und Befestigungszange.

The system consists of three components:

• 1. the thread safety cylinder (in two sizes, "S" - small and "L" - large),
• 2. the thread catcher,
• 3. the application and fastening pliers.

The thread safety cylinder, hereafter referred to as "sleeve", is preferably available in two sizes, "S" - small and "L" - large. Through the sleeve of the thread, which serves the Gefäßligatur passed. By permanent plastic deformation of the sleeve, the thread is fixed in its current position. The thread forms on the side of the vessel a loop which is placed around the vessel to be closed.

The inventive sleeve for producing an atraumatic vessel ligature accordingly consists of a hollow cylinder with two ends, wherein a first end has an atraumatic curvature, which is formed by the fact that this end has two mutually alternating bulges and depressions, and wherein the sleeve has at least one permanently plastically deformable region or consists of permanently plastically deformable material.

In other words, the system for vascular ligatures comprises a sleeve having a through opening, and is characterized in that the sleeve is permanently deformable, so that the guided through the bore part of a ligature loop is clamped in the bore.

Due to the special shape of the successive depressions and bulges a gentle concern of the sleeve is secured to a vessel. The sleeve is to be aligned so that the two protrusions rest on two opposite side walls of the vessel, and follow the two wells of the curvature of the cross section of the vessel. Thus, a twisting of the applied sleeve is excluded or at least made more difficult.

The opening of the sleeve can be designed as a through hole. It can also be provided as a branching bore, or have two parallel, separate holes.

The attachment of a Ligaturfadens done by permanent plastic deformation of the sleeve or parts thereof. A conventional node is no longer necessary. Thus, the surgeon can manually adjust the tensile strength of the ligature loop and fix it with a simple movement (e.g., squeezing the sleeve). The frequent change of tension during the necessary for the production of the node movements is eliminated.

It is preferably provided that the bulges and / or depressions smoothly merge into one another. "Soft" means that the transitions do not have cracks, kinks, sharp edges or peaks. This is important in order to allow a gentle fit of the sleeve on the vessel, and to prevent chafing of surrounding tissue and / or the ligature. Thus, the sleeve is also good for soft tissue.

The sleeve according to the invention has at its other, the atraumatic curvature opposite end of a threading aid, which preferably has the form of a trumpet-like widening. This opening allows a particularly simple threading of the ligature. It is clear that the broadening without sharp transitions from the wall of the actual sleeve emerges. It is preferred that the outer edge of the threading aid is bent so far that injuries to the surrounding tissue are excluded by this edge, or this edge is largely hidden. Thus, the angle between (approximately perpendicular) sleeve wall and edge of the widening is at least 90, and preferably at least 180 degrees.

According to a preferred embodiment, the sleeve according to the invention has an oval and in particular elliptical cross-sectional profile. The cross-sectional profile is that profile which offers a viewer whose viewing direction corresponds to the longitudinal axis of the sleeve. The cross-sectional profile is double-axisymmetric in an ellipse. The bulges are particularly preferably arranged on the two long (broad) sides, and the depressions on the two short (narrow) sides of the sleeve. For explanation, reference is also made to the description of the figures.

Preferably, the cross-sectional profile has a long half-axis which is 2.5 times as long as the short half-axis. The cross-sectional profile refers to the actual sleeve body, from which the possibly existing insertion aid is excluded. This geometry accommodates particularly well the two parallel ends of a Ligaturfadens, and it is also suitable for receiving a loop, which is formed by folding the thread.

Particularly preferably, the total length of the sleeve is 4 mm, wherein the length along the longitudinal axis is measured and possibly also includes the threading aid.

The difference between the bulge and depression is preferably 0.5 mm. This means that the total length in the area of a bulge is 0.5 mm larger than the total length in the area of a depression. For larger vessels, it is advantageous to choose the difference correspondingly larger, and for example to set to 0.25 to 0.5 times the vessel diameter.

Preferably, the width of the sleeve is 1 mm on the side, which is associated with the short half-axis of the elliptical cross-sectional profile, or 2.5 mm on the side, which is associated with the long half-axis of the elliptical cross-sectional profile.

The additional width of the threading aid is preferably circumferentially between 0.5 and 1 mm, and it is particularly preferred that this width is 1 mm in the region of the longer side and 0.5 mm in the region of the shorter side.

The wall thickness of the sleeve is preferably 0.2 mm.

It goes without saying that, depending on the specific situation (eg thread diameter, necessary length of the sleeve interior to provide sufficient clamping force, vessel diameter and softness), other than the dimensions indicated here may be useful.

The sleeve consists of or comprises a metal which is mechanically plastically deformable. It may consist of or comprise a shape memory alloy, wherein it is preferred that at an activation temperature which is slightly below body temperature, a permanent deformation occurs, which leads to a rejuvenation of the through-opening. It can also consist of a plastic, which is plastically deformable in particular by thermal action, but also by mechanical action or action by light of a specific wavelength (for example UV light). Combinations are also possible, for example a (possibly resorbable) plastic part with one or more rings of plastically deformable metal, or a metal body containing a UV-activatable plastic.

Depending on the material of the sleeve, the deformation can accordingly by heat (heat transfer, heat radiation, friction heat - for example by means of ultrasound -, electrical resistance heating, inductive heating), or by mechanical action (clamps, upsetting, pulling, crushing, ...) take place. In addition, the deformation can also be initiated by the action of light, in particular by UV light. Combinations are possible.

The invention also relates to an application and fastening forceps, in short "applicator", for placement and / or activation (plastic deformation) of the sleeve. Such an applicator according to the invention comprises a means for providing the activation energy for permanent plastic deformation of the sleeve or the at least one permanently plastically deformable region thereof. Depending on the type of activation, the applicator accordingly provides the necessary energy form (s), for example mechanical energy (forceps), electrical energy (cables, contacts), inductive energy (coil), thermal energy (heated tip), light energy (Glass fiber, LED, ...), or friction energy (ultrasonic vibrator).

In addition, the applicator may comprise a device for manipulating the length of a ligature thread, and / or for displaying and / or adjusting the tensile force acting on this ligature thread. It may, for example, be intended to hold and / or manipulate the free ends of the ligature loop, ie to shorten or lengthen it in order to achieve the desired ligature size. It is preferred that the pull acting on the free ends be palpable, displayable and / or adjustable at the proximal end of the applicator to provide the operator with information about the situation at the applicator tip (distal end). In addition, the applicator may comprise a magazine for a plurality of sleeves, which are successively available at the tip of the applicator.

In the event that the applicator is to apply mechanical deformations, this can be provided with notches, which press into the wall of the sleeve and thus lead on its inner side to a concentration of force, whereby the thread is clamped locally stronger.

The invention also relates to a system for vascular ligation, which comprises a sleeve according to the invention, as well as an applicator according to the invention and / or a thread catcher. The interaction of these components will be described below.

• – Zur Vorbereitung wird der optional vorhandene Fadenfänger, der aus einer Schlaufe, deren freie Enden in einem Griffteil verankert sind, mit einer oder mehrerer Hülsen beladen. Dazu werden die Hülsen über die Spitze der Schlaufe geschoben und im Bereich des Griffteils gehalten. Da naturgemäß die Schlaufe an ihrer Spitze breiter ausfällt als an der Verankerung des Griffteils, bleiben die Hülsen ohne weiteres Zutun ausreichend weit von der Spitze entfernt. Für diesen Fall ist es nicht nötig, dass der Applikator ein Magazin für Hülsen umfasst.
• – Nun wird der eigentliche Faden um das zu verschließende Gefäß gelegt.
• – Dann werden die freien Fadenenden durch die Schlaufe des Fadenfängers geführt.
• – Die Hülse wird weg vom Griff des Fadenfängers, zur Spitze der Schlaufe und über diese hinweg geschoben. Da die Fadenenden des eigentlichen Fadens noch in der Schlaufe „gefangen“ sind, schiebt sich die Hülse über dieselben, so dass die Hülse nun die freien Fadenenden umschließt.
• – Nun wird der Fadenfänger entfernt.
• – Die freien Fadenenden werden z.B. mittels einer Zange gehalten, und die Hülse in Richtung des Gefäßes verschoben, so dass sich die Schlinge um das Gefäß zuzieht.
• – Schließlich erfolgt eine dauerhafte plastische Verformung der Hülse mittels des Applikators, so dass der Faden in seiner letzten Position innerhalb der Hülse fixiert wird.
• – Gewünschtenfalls kann noch der überschüssige Rest der freien Enden des Fadens abgetrennt und entfernt werden.

The application of the system is therefore as follows:

• - To prepare the optional existing thread catcher, which is loaded from a loop whose free ends are anchored in a handle part, with one or more sleeves. For this purpose, the sleeves are pushed over the top of the loop and held in the region of the handle part. Since, of course, the loop at its tip turns out to be wider than at the anchorage of the handle, the sleeves remain without further action sufficiently far away from the top. In this case, it is not necessary for the applicator to include a magazine for sleeves.
• - Now the actual thread is placed around the vessel to be closed.
• - Then the free thread ends are guided through the loop of the thread catcher.
• - The sleeve is pushed away from the handle of the thread catcher, to the top of the loop and over it. Since the thread ends of the actual thread are still "caught" in the loop, the sleeve slides over the same, so that the sleeve now encloses the free thread ends.
• - Now the thread catcher is removed.
• - The free ends of the thread are held, for example by means of pliers, and the sleeve is moved in the direction of the vessel, so that the loop is tightened around the vessel.
• Finally, there is a permanent plastic deformation of the sleeve by means of the applicator, so that the thread is fixed in its last position within the sleeve.
• - If desired, the excess remainder of the free ends of the thread can be separated and removed.

An advantage of the present invention is the provision of a system which is independent of the diameter or the structure of the vessel. The consumables - thread and sleeve - can be produced at very low cost. The system is extremely space-saving and therefore also applicable in the field of minimally invasive surgery. Particularly suitable is the system for the removal of benign and malignant lung tumors, the so-called atraumatic lung resection such. the lobectomy.

figure description

In the 1 is that as a sleeve 1 designed Fadenabsicherungszylinder shown in a first side view (long / wide side). This consists essentially of a hollow cylinder through which the free ends of the thread (not shown) can be performed.

On the side facing away from the vessel (top of the picture) (first end 2 ), and on which the open ends of the thread (not shown) are located, the sleeve has 1 an atraumatic vaulting 4 on. The atraumatic curvature according to the invention 4 is designed so that it has no sharp edges and corners, for example, by rubbing the surrounding and adjacent tissue (not shown) not to hurt. It is formed by the fact that the first end 2 the sleeve 1 two mutually alternating bulges 5A . 5B and depressions 6A . 6B having.

On the side facing the vessel (other end 3 , in the picture below) shows the sleeve 1 a threading aid 7 on. This particularly preferably has the form of a trumpet-like broadening. With such a threading aid 7 a thread can be easily inserted into the sleeve.

Like from the 1 seen, the sleeve has 1 a total length L on. Between bulge 5A . 5B and deepening 6A . 6B there is a difference D, resulting in a minimum length Lmin of the sleeve 1 results. The visible in the view shown width B1H of the sleeve 1 (without the threading aid 7 ) is eg 2.5 mm. The maximum width including the threading aid 7 B1max is for example 3 mm in this view.

The 2 shows the sleeve 1 in another side view (short / narrow side). It becomes clear which shape the atraumatic curvature 4 particularly preferably.

The width of the sleeve in this view (B2H) is approximately half of the maximum width B2max. The first end 2 arranged recess 6A . 6B the atraumatic vaulting 4 has in the projection shown on the sheet about a semicircular shape.

The 3 shows the sleeve 1 from above, looking in the direction of the longitudinal axis. Like from the 3 seen, has the sleeve 1 preferably an oval, in particular elliptical shape. The cross-sectional area therefore preferably represents an ellipse which has a long semiaxis a and a short semiaxis b. Of course, other cross sections, such as round or rectangular, possible.

The wall thickness W is preferably 0.2 mm. The hatched area is the threading aid 7 assigned.

In the 4 is the thread catcher 8th shown in a preferred embodiment. On a handle 9 is a thin metal loop 10 appropriate. With this, the thread (not shown) can be captured after the thread catcher 8th with the loop 10 through the sleeve (not shown) was performed. By retracting the thread by means of the loop 10 The thread is pulled through the sleeve on the side of the atraumatic curvature, where it can then be fixed by means of the sleeve.

LIST OF REFERENCE NUMBERS

1

shell

2

first end

3

other end

4

atraumatic vaulting

5A, 5B

bulges

6A, 6B

wells

7

threader

8th

thread catcher

9

Handle

10

Metal loop, loop

a

long half-axle

b

short half-axle

L

overall length

Lmin

minimum length

D

difference

B1H

Width of the sleeve (wide side)

B2H

Width of the sleeve (narrow side)

B1max

maximum width (wide side)

B2max

maximum width (narrow side)

W

Wall thickness

Claims (10)

Sleeve ( 1 ) for producing an atraumatic vessel ligature, consisting of a hollow cylinder with two ends ( 2 . 3 ), with a first end ( 2 ) an atraumatic curvature ( 4 ) formed by having said end ( 2 ) two mutually alternating bulges ( 5A . 5B ) and depressions ( 6A . 6B ), and wherein the sleeve ( 1 ) has at least one permanently plastically deformable region or made of permanently plastically deformable material. A sleeve according to claim 1, wherein the bulges ( 5A . 5B ) and / or depressions ( 6A . 6B ) softly merge into each other. Sleeve ( 1 ) according to claim 1 or 2, wherein the same at its other end ( 3 ) a threading aid ( 7 ) in the form of a trumpet-like broadening. Sleeve ( 1 ) according to one of claims 1 to 3, wherein it has an elliptical cross-sectional profile. Sleeve ( 1 ) according to claim 4, wherein the cross-sectional profile has a long half-axis (a) which is 2.5 times as long as the short half-axis (b). Sleeve ( 1 ) according to claim 5, wherein the total length (L) is 4 mm and the difference (D) between the bulge ( 5A . 5B ) and deepening ( 6A . 6B ) 0.5 mm, and / or at which the width of the sleeve (B1H, B2H) 1 mm or 2.5 mm and the additional width of the threading aid ( 7 ) circumferentially between 0.5 and 1 mm, and / or at which the wall thickness (W) is 0.2 mm. Sleeve ( 1 ) according to one of the preceding claims, wherein it consists of or comprises material which is selected from the group consisting of metals and plastics, or consists of a shape memory alloy with an activation temperature of over 35 degrees Celsius. Applicator for a sleeve ( 1 ) according to one of the preceding claims, comprising means for providing the activation energy for permanent plastic deformation of the sleeve ( 1 ) or the at least one permanently plastically deformable region thereof. An applicator according to claim 8, further comprising a magazine for at least one sleeve ( 1 ), and means for manipulating the length of a ligature thread, and / or for displaying and / or adjusting the tensile force acting on this ligature thread. System for vascular ligation, comprising a sleeve ( 1 ) according to one of claims 1 to 7, as well as an applicator according to one of claims 8 or 9 and / or a thread catcher ( 8th ).

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