EP2355710A2 - Système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire - Google Patents

Système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire

Info

Publication number
EP2355710A2
EP2355710A2 EP09795306A EP09795306A EP2355710A2 EP 2355710 A2 EP2355710 A2 EP 2355710A2 EP 09795306 A EP09795306 A EP 09795306A EP 09795306 A EP09795306 A EP 09795306A EP 2355710 A2 EP2355710 A2 EP 2355710A2
Authority
EP
European Patent Office
Prior art keywords
shaft
needle
surgical
thread
legs
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09795306A
Other languages
German (de)
English (en)
Inventor
Norbert Lemke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medi-globe GmbH
Medi Globe GmbH
Original Assignee
Medi-globe GmbH
Medi Globe GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medi-globe GmbH, Medi Globe GmbH filed Critical Medi-globe GmbH
Publication of EP2355710A2 publication Critical patent/EP2355710A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00663—Type of implements the implement being a suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle

Definitions

  • Surgical thread positioning system for closing an opening within a tissue wall
  • the invention relates to a surgical Fadenpositioniersystem for closing an opening within an intracorporeal tissue wall having an elongated shaft having a distal shaft portion on which a means is provided, which extends from a position flush with the shaft in a position radially projecting the shaft is reversibly convertible, and at least partially surrounding the shaft radially and / or integrated into the shaft needle guide unit in which at least one longitudinally of the shaft movably arranged needles is guided, which from a retracted position in one, in which the shaft radially projecting Position located means interacting, distal position is reversibly reversible.
  • Surgical instruments of the above type are used in cases in which a rapid and patient-friendly reclosure of vessel wall openings formed by incision or free cutting, for example on blood-carrying hollow vessels, is to be undertaken.
  • sewing devices can be counteracted effectively hematoma, especially on the Use of pressure or compression bandages, which are usually used for purposes of hemostasis on a self-healing vessel wall opening, can be largely dispensed with.
  • Sewing devices of the type mentioned are known in many embodiments and have mostly at the distal end of a shank-shaped hollow instrument, which is suitable for performing a locally minimally invasive procedure differently trained Nähnadelapplikatoren, with which it is possible, one or more surgical sutures in the tissue area directly in order to fasten the opening to be closed looped or loop-like, in order to close the opening mechanically by gently pulling together the thread loop in order to accelerate the natural healing process.
  • the sewing device described in DE 693 34 017 T2 provides at the distal end of a hollow instrument a slidable over the distal end of the hollow instrument, via two radially expandable to the hollow instruments sewing needles whose needle ends are each connected to a continuous sewing thread.
  • the intracorporeal application of the sewing needles takes place in such a way that the hollow instrument is pushed through the tissue wall opening to be closed, the sewing needle device being pushed distally from the hollow instrument via a guide unit guided within the hollow instrument and the sewing needles occupying a radially splayed position.
  • the hollow instrument is withdrawn through the vessel wall opening to be closed, thereby forming a reticulated outside the vessel to be treated widening the hollow instrument, reticulated receiving device into which the needle tips in the process of retraction of the needle assembly, after the needles surrounding the opening tissue wall edge region completely have penetrated barb-like.
  • the interior of the vessel retracts forming suture loop together and completely closes the vessel wall opening.
  • a further surgical suturing device based on the above-described principle of "capture” or “grasping” a suture loop introduced inside a vessel to be occluded with the aid of a barb-shaped suture needle is the subject of DE 698 35444 T2.
  • the known device uses at least two needles which are each driven through the fabric edge region to be closed. One of the two needles carries a looped thread, the other needle is pushed without sewing thread through the vessel wall and has at its distal tip a barb-shaped recess with which the spent inside the vessel thread loop is to be taken.
  • both sewing needles are gently withdrawn, whereby a thread loop laid over the opening twice forms, which leads in the same way as in the above-described devices by gentle pulling to a closure of the vessel opening.
  • Devices based on the above-described principle of capturing or gripping an intracorporeally introduced thread loop can likewise be taken from DE 697 37 897 T2 and DE 699 25 185 T2.
  • the generic device is the subject of DE 199 42 951 C1.
  • the device provides at its distal end region a thread guiding device which has in its longitudinal direction a rear thread feed part, a front thread receiving part and an intermediate middle thread release / thread clamping part.
  • the middle Fadenuza- / Fadenklemmteil is rotatably mounted relative to the front thread receiving part and also has such a cross-section that the Fadenuza- / Fadenklemmteil allows in at least one rotational position, the introduction of the supplied from the rear yarn feeding part sewing threads in the front thread receiving part exposed receiving openings.
  • the Fadenuza- / Fadenklemmteil In one of the said rotational position different rotational position, it is possible in the respective receiving openings together with the needles recorded sewing threads for pulling out the entire thread guide device from said tissue wall opening out hold.
  • the known device ensures by the fixed predetermined spatial allocation of the three parts of the yarn guide device described above, a clear and secure handling of the sewing threads for placement of a sewing thread loop in the area surrounding the opening vessel wall.
  • US Pat. No. 5,954,532 discloses a surgical suturing device whose structure and function are illustrated in different embodiments in each case in FIGS. 11 to 25.
  • the surgical suturing device provides a medical hollow instrument in which an internal shaft is longitudinally movably guided whose distal end projects beyond the hollow instrument on the distal side.
  • an elastomeric element is mounted, which can be transferred from an elongated, substantially flush to the shaft position in a the diameter of the hollow instrument radially superior shape by way of material compression or squeezing, by retraction of the stem relative to the hollow instrument can be initiated.
  • the elastomeric element flush with the distal shaft region is passed through a tissue opening to be occluded, the surgical hollow instrument with the needles attached thereto being placed on the outside of the tissue opening. Due to the corresponding radial widening of the elastomeric element and the subsequent needle feed, the needles each penetrate from the outside the fabric wall immediately surrounding the fabric opening and then pass into the radially expanded elastomeric element. By subsequently retracting the needles, however, the thread in each case remains in the radially expanded elastomeric element and thus also in each case in the puncture channels caused by the needles through the fabric wall. Finally, the suture ends, since they remain in the elastomeric element by appropriate removal of the shaft through the tissue opening to be closed together with the elastomeric element proximally to the tissue opening and form in this way a tissue loop closing the tissue opening.
  • the invention is based on the object, starting from the above-described prior art according to US 5,954,732 a further improvement in ease of use while ensuring safe handling of all required for the production of the vessel wall opening closing thread loop device components specify.
  • it is a generic device to specify, with which it is possible to close tissue openings with large opening diameters, ie greater than 5 mm, as they occur in abdominal surgery or similar surgical measures.
  • Such large tissue openings can not or not reliably closed with the known surgical suturing device, especially as the achievable by material squeezing radial projection of the elastomeric element is too small over the size of the tissue opening to be closed. Since the thread pull forces required to close a tissue opening increase with increasing aperture size, there is a need for a sufficiently large clearance between the needle edge ports near the edge through the tissue and tissue aperture to reduce the cutting action of the tensioned thread to corresponding tissue areas.
  • a surgical thread positioning system for closing an opening within an intracorporeal tissue wall with an elongated shaft having a distal shaft region on which is provided an elastomeric material at least partially displacing from a position flush with the shaft Shaft radially superior position is reversibly convertible, and provided on the shaft needle guide unit in which at least one longitudinally of the shaft movably arranged needle is guided, which is reversibly reversible from a retracted position to an advanced distal position in which the needle in the Stem protruding radially projecting position pierces means, wherein by returning the needle in the retracted position, a thread entrained by the means remains in the middle, further developed such that the means via radially spreadable from the shaft Has legs that interact with an element in operative connection, so that the legs are reversible from the position flush with the shaft in the shaft radially projecting position.
  • the surgical thread positioning system makes use, as it were of the surgical sewing apparatus according to US Pat. No. 5,954,732, of the elastic properties of an agent consisting of an elastomeric material, for forming a sewing thread loop in the region of a tissue opening to be closed.
  • the radial expansion of the elastomeric element takes place neither in the context of material squeezing nor is the elastomeric element subject to an associated, material-related limitation with respect to the maximum radial expansion; rather, the radial expansion of an agent consisting of elastomeric material is based on the forming and Size selection of a body having at least two leg which can be spread apart, whose training possibilities are referred to below.
  • the legs For purposes of spreading the legs, they are laterally deflected either by means of a suitably placed dilatable element, in the form of a swelling body, or by moving the elastomeric shaped body relative to a displacement contour along which the legs slide. It is also conceivable in principle to deflect the legs of the shaped body by means of a suitably designed and controllably drivable mechanism.
  • the tissue opening diametrically opposite hollow needles threaded through each a continuous surgical suture so that the thread protrudes respectively at the needle tip of both needles and each immediately returned longitudinally to the needle outside, both the vessel wall and the immediately adjacent to the vessel wall inside elastomeric leg, preferably completely.
  • both hollow needles are withdrawn on the proximal side, but the thread segments passing through the elastomeric legs remain within the legs due to the elastic clamping or retention forces acting on the respective thread sections.
  • the needles on the one hand due to their smooth needle surfaces readily and without effort from the.
  • the immediate frictional contact between the surgical thread and the elastomer material comes about in the thread section, respectively runs longitudinally to the needle outside the needle surfaces.
  • the solution according Fadenfadeniersystem can basically train and use only with a single surgical hollow needle. For this, however, it is necessary to repeat the above-described piercing operation at least once at a further tissue site. On the other hand, surgical interventions are conceivable in which there is a need for only a single thread fixation in the tissue area.
  • Needle positioning system with a) applied legs and b) splayed legs
  • Fig. 5 a, b alternative embodiment of a spreading mechanism of the legs.
  • FIGS. 1a-c depict a three-side view of a hand-held surgical thread positioning system for closing an opening within an intracorporeal tissue wall.
  • the basic components of a known syringe which consists of a slightly modified cylindrical syringe body 1 and a longitudinally movably guided within the cylinder-shaped syringe body 1 syringe plunger 2 are.
  • the syringe plunger represents for a surgeon the only actuator that needs to be operated to perform the entire sewing process.
  • a shaft 3 is firmly inserted, which projects beyond the syringe body 1 distal side and seals with the syringe body 1 fluid-tight.
  • the shaft 3 provides at its distal end region a conical taper 4, which is adjoined by a shaft region 5 with reduced shaft diameter, which ends in a rounded end cap 5 ', which has a cap diameter corresponding to the cross section of the shaft 3.
  • the shaft described above is formed integrally from biocompatible material, ie, the shaft portions with the reference numerals 3, 4, 5 and 5 1 are integrally formed from a single material
  • two needle guide channels 6, 7 are introduced (see cross-sectional front and rear side in Figure 1a and c), which provide each distal end a bend with a laterally oriented to the shaft longitudinal extension channel opening 6 1 and T.
  • Within the respective needle guide channels 6, 7 are each a needle 8, 9 mounted longitudinally movable to the shaft longitudinal axis.
  • the respective proximal needle end are fastened to a needle guiding element 10 guided longitudinally movably within the syringe body 1.
  • a hollow channel 12 extends through the shaft 3 and at least partially the reduced diameter shaft portion 5.
  • the hollow channel 12 extends rearwardly to the shaft 3 in the form of a fixed tube 13 whose rear open end 14 is surrounded by a centering and sealing member 15, which in turn rests in a fluid-tight manner against the inner wall of the syringe plunger 2 mounted so as to be movable longitudinally relative to the syringe body 1.
  • the centering and sealing element 15 closes with the syringe plunger 2 due to a provided on the peripheral edge of the centering and sealing element 15 seal 15 'a fluid-tight volume 16, which is filled with a medium, preferably air.
  • the distal end of the hollow channel 13 opens within a dilatable element 17, which is attached to the reduced in cross-section shaft portion 5.
  • the dilatable element 17 is preferably in the form of a tubular body surrounding the shaft region 5 inflatable body, which has an elastically deformable, in the inflated state toroidal shell wall. in the In the case of the embodiment shown in FIG. 1 ac, the inflatable body is emptied and assumes a largely flush shape resting against the shaft region 5.
  • the means 18 has a ring-shaped base portion 18 ', which is preferably firmly attached to the end cap 5', for example by means of gluing. Details of the means 18 are shown in FIGS. 2a-c.
  • the means 18 preferably represents a molded body made of an elastomeric material, which has a substantially hollow cylindrical basic shape whose diameter corresponds to the diameter of the shaft 3. Above the base region 18 'protrude two legs 19, 20, which are integrally connected to the base region 18'.
  • the legs 19, 20 can be transferred from a so-called flush with the shaft position, as shown in Figures 1a-c and 2a, in a so-called the shaft radially superior position or spread position, as shown for example in Figure 2b is shown.
  • the legs 19, 20 have a notched surface 19 ', 20' facing the base region 18 ', which is oriented inclined relative to the surface 18' o of the base region 18 '.
  • the notched surfaces 19 ', 20' rest respectively on the surface 18 'o of the base region 18', so that the pivoting range of both legs 19, 20 is limited in a defined position.
  • the lateral swiveling width w illustrated in FIG. 2b can be predetermined on the one hand by the limb length I (see FIG. 2a) and also by the orientation of the notched surfaces 19 ', 20'.
  • the means 18 made entirely of elastomeric material can be made in a particularly advantageous manner from a piece of hose which provides the recesses removable from FIGS. 2a and b.
  • the legs 19, 20 thus represent hollow cylindrical tube part wall sections and thus have around the center axis curved wall sections. Such a design of the legs 19,20 supports a self-driving provision of the splayed legs 19,20 in the flush starting position as soon as an external mechanical constraint to spread away.
  • the top view shown in FIG. 2 c of the respectively spread legs 19, 20 illustrates the hose-wall-like design of the legs 19, 20.
  • FIG. 3 a shows a longitudinal section through the shaft 3, which merges in one piece into the shaft region 5, which is reduced in cross-section, which ultimately ends in one piece in the shaft end cap 5 '.
  • the elastomeric material means 18 attached to the distal shaft region assumes a flush position with respect to the shaft 3 and in this way can be placed through a tissue opening 22.
  • the dilatable element 17 emptied and thus assumes a shape flush with the shaft region 5.
  • hollow needle 8 remains in a fully retracted inside the shaft 3 position.
  • the dilatable element 17 is filled with a suitable medium, preferably air, whereby the legs 19, 20 are displaced in a radially projecting position from the shaft.
  • the filling of the dilatable element 17 is effected by feeding preferably air along the hollow channel 12 in a manner to be explained in more detail below.
  • the dilated element 17 helps to center the spread limbs 19, 20 relative to the tissue opening 22 to be closed.
  • the dilated element 17 bears against the tissue opening 22 in a fluid-tight manner and thus ensures a fluid-tight seal
  • a fluid-tight closure is particularly advantageous in the performance of surgical measures in the abdomen, in which for the purpose of minimally invasive interventions an intracorporeal overpressure is produced, which is not impaired due to the above-mentioned gas-tight closure.
  • the needles 8, 9 are extended along the respective needle guide channels 6, 7 and puncture the laterally spread legs 19, 20.
  • the entrained with this thread remains due to the mechanism explained in the introduction within the elastomeric material leg 19,20.
  • both legs 19, 20 can be placed through the tissue region 26 correspondingly far from the immediate tissue opening, so that the puncture channels 24 through these puncture channels 24 , 25 entrained thread is able to hold enough tissue material, with the safe closing of the tissue opening 22 can be guaranteed.
  • the size of the legs 19,20 can be chosen suitably large depending on the size of each tissue opening to be closed.
  • the dilatable element 17 is filled with air by the syringe plunger 2 is depressed kraftbeaufschlagt, whereby the air located in the volume region 16 is forced through the hollow channel 12 into the dilatable element 17.
  • the dilatable element 17 inflates in the manner shown in Figure 4a and at the same time spreads the legs 19,20.
  • the force to be applied with which the syringe plunger 2 is to be pressed down, noticeably increases, especially with a further depression against the spring force of the spring 11 is to be pressed.
  • the syringe plunger 2 is advanced distally against the spring force of the spring 11, the hollow needles 8, 9 together with the thread 21 exiting the shaft 3 distally and each puncture through a tissue region which lies at a distance from the tissue opening 22.
  • the piercing operation is completed as soon as the syringe plunger 2 has reached an end stop, in which the spring 11 is completely compressed and the syringe plunger 2 rests largely over the fully compressed spring 11 on the proximal end face of the shaft 3 via the needle guide element 10.
  • the respective needles 8, 9 pierce the splayed legs 19, 20 completely, as shown in the sequence image representation according to FIG. 4 c.
  • the needle positioning system assumes the shape illustrated in FIG. 4d and can be withdrawn proximally from the tissue opening 23.
  • the result remains a surgical suture loop 21 on the inside of the tissue opening 23, which is further reduced by contraction, thereby closing the tissue opening.
  • FIG. 5a shows the state in which the legs 19, 20 lie flush with the shaft 3.
  • the distal end of the shaft 3 has a wedge-shaped displacement contour 28, slide the inner sides of the legs 19, 20 along the displacement contour 28, while the guide member 27 is retracted proximally relative to the shaft 3.
  • the legs 19,20 are automatically spread apart laterally to the shaft longitudinal extent due to the displacement contour 27.

Abstract

L'invention concerne un système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire intracorporelle, comportant une tige allongée présentant une zone de tige distale dans laquelle un moyen au moins partiellement composé d'élastomère est prévu, ledit moyen pouvant être déplacé d'une position jointive avec la tige vers une position radialement saillante par rapport à la tige, et inversement; et une unité de guidage d'aiguille prévue sur la tige, dans laquelle au moins une aiguille disposée mobile le long de la tige est guidée. L'aiguille peut être déplacée d'une position rétractée vers une position distale avancée, et inversement. Dans la position distale avancée, l'aiguille traverse le moyen se trouvant dans la position radialement saillante par rapport à la tige. Lorsque l'aiguille est ramenée dans la position rétractée, un fil guidé à travers le moyen reste positionné dans l'élément. L'invention est caractérisée en ce que le moyen est pourvu de branches s'écartant radialement de la tige, entrant en liaison fonctionnelle avec un élément de telle manière que les branches peuvent être déplacées de la position jointive avec la tige vers la position radialement saillante par rapport à la tige, et inversement.
EP09795306A 2008-10-29 2009-10-29 Système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire Withdrawn EP2355710A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008053809A DE102008053809A1 (de) 2008-10-29 2008-10-29 Chirurgisches Fadenpositioniersystem zum Verschließen einer Öffnung innerhalb einer Gewebewand
PCT/DE2009/001532 WO2010048945A2 (fr) 2008-10-29 2009-10-29 Système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire

Publications (1)

Publication Number Publication Date
EP2355710A2 true EP2355710A2 (fr) 2011-08-17

Family

ID=42096290

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09795306A Withdrawn EP2355710A2 (fr) 2008-10-29 2009-10-29 Système de positionnement de fil chirurgical pour refermer une ouverture située dans une paroi tissulaire

Country Status (4)

Country Link
US (1) US20110270282A1 (fr)
EP (1) EP2355710A2 (fr)
DE (1) DE102008053809A1 (fr)
WO (1) WO2010048945A2 (fr)

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WO2010048945A2 (fr) 2010-05-06
US20110270282A1 (en) 2011-11-03
WO2010048945A3 (fr) 2010-07-15

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