Three-dimensional annular suture device for vascular and gastrointestinal anastomoses

Abstract

Currently, anastomoses are performed by manual or mechanical suturing. Manual suturing uses unidirectional or bidirectional linear threads. The present invention allows anastomoses to be structured in three dimensions, facilitating access to the anastomotic edges. The device disclosed herein comprises a three-dimensional annular suture means for gastrointestinal and vascular anastomoses, formed by an annular frame (7) with multiple suture threads (6 and 9). The ring (7) defines the size of the anastomosis, functions as a frame for mucosal apposition, and supports the threads (6 and 9), making the anastomosis faster and more precise. The device can be made from absorbable or non-absorbable material, with smooth (6) or barbed (9) monofilament or multifilament threads, the needles (8) of which vary according to the intended use. It can be used in open, laparoscopic or robotic surgeries. It has magnetic strips (12) for organising the needles (8) and a collection array (3) with magnetic receptacles (4) for the safe disposal of the items used. This system contributes to greater efficiency and intraoperative management, ensuring that all of the items are organised and collected correctly at the end of the procedure, optimising the safety and precision of the surgical technique.

Description

[0001] Three-dimensional annular suture device for vascular and gastrointestinal anastomoses.

[0002] Technological sector of the utility model

[0003]

[0001] This utility model patent refers to a three-dimensional annular suture device for use in digestive, vascular or cardiovascular anastomoses, characterized by being composed of an annular framework assembled with needled suture threads.

[0004] Known state of the art

[0005]

[0002] To this day, anastomoses are performed by manual suturing or mechanical suturing (staplers). Even in the case of mechanical sutures, it is necessary to close the hole through which the stapler penetrates by manual suturing. Manual suturing is performed with linear suture threads, generally unidirectional and sometimes bidirectional (double-needle). Thus, the connection between two tubular structures ends up being made with linear suture. The greatest difficulties encountered in the anastomosis procedure are: identification and apposition of the anastomotic edges, final calibration of the size of the sutured openings, and presentation of the edges during the procedure.

[0006]

[0003] The present utility model allows the anastomosis to be structured in three dimensions, making it easier for the surgeon to access the anastomotic edges. With this device, the surgeon can grasp and freely visualize the edges, as well as pass the needles with greater precision through the walls of the viscera, achieving better edge apposition, with excellent apposition of the mucosa or endothelium. The three-dimensional structuring also allows for more precise calibration of the anastomotic openings, reducing the chances of fistulas and stenoses.

[0007]

[0004] That said, there are also some alternatives that represent the current state of the art and are described in patent documents. Some examples can be seen in the case of patent PI0904144-3 "ANASTOMOSIS AND SUTURE FACILITATING DEVICE". This patent discloses a device to assist in sutures and anastomoses, using suture repair and fixation structures for intraoperative stabilization. However, this technology does not include an adjustable modular system, nor integrated accessories such as magnetic strips and a collection template, which optimize intraoperative organization in the patent application described.

[0008]

[0005] Another example can be seen in the case of patent EP1 175868 "CIRCULAR ANASTOMOSIS DEVICE". This document describes a pre-molded circular anastomosis device, designed for structured procedures. It has a ring with multiple predefined suture points, allowing junctions to be performed in a uniform and calibrated manner. However, this technology does not include an adjustable three-dimensional ring, nor does it differentiate applications between cardiac, vascular, and digestive surgeries, as in the patent application analyzed.

[0009]

[0006] In patent EP0568774 "ENDOSCOPIC ANASTOMOSIS RING INSERTION DEVICE", another alternative present in the state of the art is observed. This endoscopic system uses an anastomosis ring with actuators for mechanical closure and precise insertion. However, there are no details on absorbable and non-absorbable materials, nor structured alternatives for different surgical approaches, as in the patent application analyzed.

[0010]

[0007] Another alternative can be seen in US patent 9,597,071 "APPARATUS AND METHOD FOR MINIMALLY INVASIVE SUTURING". This document discloses an automated suturing system incorporating internal drive mechanisms and mechanical fixation. Despite its automated functionality, it does not present a manual system applicable to traditional procedures, nor accessories that organize the needles and threads, facilitating intraoperative management.

[0011]

[0008] Furthermore, note the US patent 20060020272 "SEMI-ROBOTIC SUTURING DEVICE". This semi-robotic device operates with electronically controlled mechanical arms, allowing automatic adjustments to the suture. Despite the similarities with the concept presented, it does not specify an adjustable three-dimensional ring, nor solutions that allow versatile adaptation between vascular and gastrointestinal anastomoses.

[0012]

[0009] Another alternative can be seen in patent PI1010142-0 "SYSTEM FOR GASTROINTESTINAL PROCEDURE". This document presents a system for performing minimally invasive gastrointestinal procedures, using an excision device and a suturing mechanism with trigger actuation. Although its approach is technically compatible with the concept of the patent application, it does not present structured options for an adjustable ring, nor auxiliary systems for organizing and counting needles.

[0013]

[0010] Finally, patent EP1908422 "IMPROVEMENTS RELATING TO AN ANASTOMOTIC RING APPLIER" exemplifies another alternative present in the state of the art. This document describes an anastomosis ring applicator, operating with specific insertion and fixation mechanisms. However, it does not have a modular manual suturing system, nor alternatives for different types of sutures and materials, as is the case in the patent application analyzed.

[0014]

[0011] Given all the drawbacks of the systems and devices currently used, described above in the state of the art, a gap is evident in the creation of a manual three-dimensional annular suture device that integrates variations of materials, including absorbable and non-absorbable options for different types of anastomoses; features an adjustable modular system, allowing variations in the quantity and thickness of suture threads; includes advanced organizational solutions, such as magnetic strips and a collection template for better management of intraoperative needles; and allows adaptation for both conventional surgeries and minimally invasive procedures, ensuring enhanced versatility and precision.

[0015]

[0012] Thus, none of the analyzed prior art fully presents the innovative characteristics of the three-dimensional annular suture device, justifying its inventive step and demonstrating its technical advantage. Description of the attached drawings

[0016]

[0013] In order for the present device to be fully understood and put into practice by any technician in this technological sector, it will be described in a clear, concise and sufficient manner, based on the attached drawings, which illustrate and support it, listed below:

[0017]

[0014] Figure 1 illustrates the envelope of the three-dimensional annular suture device (PASSBY) containing the device.

[0018]

[0015] Figure 2 shows the drawing of the template box used by the surgical instrument technician to collect specimens used in the surgical procedure.

[0019]

[0016] Figure 3 shows a three-dimensional view of the template box used by the surgical instrument technician to collect specimens used in the surgical procedure.

[0020]

[0017] Figure 4 represents the magnetic strips used to organize the needles.

[0021]

[0018] Figure 5 illustrates the three-dimensional annular suture device assembled with two needled suture threads.

[0022]

[0019] Figure 6 illustrates the three-dimensional annular suture device assembled with three needled suture threads.

[0023]

[0020] Figure 7 illustrates the three-dimensional annular suture device assembled with four needled suture threads.

[0024]

[0021] Figure 8 illustrates the three-dimensional annular suture device assembled with eight needled suture threads.

[0025]

[0022] Figure 9 illustrates the three-dimensional annular suture device assembled with two needled barbed suture threads.

[0026]

[0023] Figure 10 illustrates the three-dimensional annular suture device assembled with three barbed suture threads with needles.

[0027]

[0024] Figure 11 illustrates the three-dimensional annular suture device assembled with four needle-tipped barbed suture threads.

[0028]

[0025] Figure 12 illustrates the three-dimensional annular suture device assembled with five barbed suture threads.

[0026] Figure 13 illustrates a model of a non-absorbable three-dimensional annular suture device assembled with four polypropylene sutures (PASSBY V) being applied in vascular anastomosis.

[0029]

[0027] Figure 14 illustrates a model of a three-dimensional absorbable annular suture device assembled with five barbed sutures (PASSBY gastrointestinal) being applied in gastrojejunal anastomosis.

[0030]

[0028] Figure 15 illustrates a model of a three-dimensional absorbable annular suture device (PASSBY V) being applied in pancreaticojejunal anastomosis.

[0031] Detailed description of the utility model

[0032]

[0029] The three-dimensional annular suture device is best described by the following reference numerals:

[0033] • Envelope of the three-dimensional annular suture device (1)

[0034] • Enveloped three-dimensional annular suture device (2)

[0035] • Template box (3)

[0036] • Magnetized receptacle for needle (4)

[0037] • Metal receptacle for storing each magnetic strip (5)

[0038] • Suture thread (6)

[0039] • Ring (7)

[0040] • Needle (8)

[0041] • Barbed suture thread (9)

[0042] • Fasting (10)

[0043] • Pancreatic duct (1 1 )

[0044] • Magnetic strip (12)

[0045]

[0030] The present utility model describes a three-dimensional annular suture device (1) as a suture device characterized by being annular and assembled with needled suture threads (6 and 9) for use in anastomoses, both digestive and vascular. It is formed by an annular framework (7) with assembled suture threads (6 and 9), allowing the structuring of anastomoses in three dimensions. The central ring (7) delimits the size of the anastomosis, functions as a framework for mucosal apposition and supports the suture threads (6 and 9). In this way, the anastomosis is assembled in three dimensions, making the procedure easier, faster and more precise. The device has various shapes and compositions, and can be made of either absorbable or non-absorbable material. It can be manufactured with monofilament or multifilament suture threads, being either smooth (6) or barbed (9).The suture threads (6 and 9) can vary in length and diameter, as can their needles (8). The device configuration will depend on the location where it will be applied. The figures, shapes, and compositions described here are illustrative and not restrictive; other compositions may be used in the same concept.

[0046]

[0031] The previously existing suture threads (6 and 9) are composed of needled (8) or double-needled (bidirectional) threads and are used linearly, working very well in flat tissues such as skin. However, in anastomosis situations, where the surface to be sutured is circumferential or involves the connection of two tubular structures, there is greater complexity. The present device allows structuring anastomoses in three dimensions, facilitating the adjustment of the edges and making the procedure easier and more precise.

[0047]

[0032] The device has presentations with absorbable and non-absorbable sutures. The device with non-absorbable sutures is mainly used for cardiac and vascular surgeries, while the absorbable device is mainly used for digestive or gastrointestinal surgeries. The non-absorbable device can be made of materials such as polypropylene, polyethylene, terephthalate, or nylon, among others. The absorbable device can be made of materials such as 1,4-dioxane-2-one (polydioxanone), epsilon-caprolactone (poliglecaprone), glycolide (polyglycolic acid), or lactide (polyglactin), among other materials. For gastrointestinal sutures, barbed sutures are mainly used (9).

[0048]

[0033] The device can be manufactured in various ring (7) and suture thread (6 and 9) sizes. The suture size used is determined primarily according to the location, strength, and condition of the tissue to be sutured. The ring size (7) is variable, as is the thickness of the suture threads (6 and 9). It is accompanied by a kit that includes magnetic strips (12), which help maintain organization and separation of the needles (8), as well as a collection template (3) for the disposal and verification of the needles (8) removed from the abdominal cavity at the end of the procedure. The template (3) has a magnetized receptacle (4) for each needle (8) of the device and a metal receptacle (5) to store each magnetic strip (12). Both the magnetic strips (12) and the collection template (3) form a set with the suturing device and are necessary for the use of the device for the orderly handling of the needles (8) and correct disposal after the end of the procedure.

[0049]

[0034] The non-absorbable device is mainly used in vascular anastomoses, with one device (1) positioned at each vascular end, externally to the vessel (10). The needles (8) pass through the vascular wall from the adventitia to the endothelium, everting edges, and shaping anastomotic openings of equal size. From this point, the anastomosis is performed conventionally, but more quickly, better calibrated, and with better endothelial apposition, due to the framework formed by the ring (7) of the device.

[0035] The absorbable device is mainly used in gastrointestinal anastomoses. The needles (8) are inserted from the mucosa to the serosa, positioning the device inside the viscera (10), in contact with the mucosa, structuring a three-dimensional framework that facilitates the anastomosis and directs mucosal healing with excellent coaptation and speed.

[0050]

[0036] For the manufacture of the device, suture threads (6 and 9) are made and fixed to needles (8). A ring (7) is made with variable diameter, thickness and hardness. The needled suture threads (6 and 9) are connected to the ring (7). The number of suture threads (6 and 9) in each ring (7) will depend on the model and application in which it will be used. Magnetic strips (12) accompany the device to assist in the control and organization of the needles. For laparoscopic or robotic surgeries, the magnetic strips are generally rectangular. For use in open surgeries such as jejunopancreatic anastomosis, only a larger magnetic strip, in a “U” shape (12), can be used. (8). In addition to the three-dimensional annular suture device (1) and the magnetic strips (12), the kit is accompanied by a template (3) for the collected material.This template (3) is a box with curved magnetized cavities (4), where the needles (8) are deposited after use, as well as locations for depositing the magnetic strips (5). The template serves to assist in controlling the material used and certifying that all parts have been removed from the abdominal cavity. The annular suture devices with needled suture threads are packaged with the kit and then sterilized with ethylene oxide (EO) or gamma sterilization, for example.

[0051]

[0037] The device is packaged in an envelope (1). This flexible envelope can be inserted into the abdominal cavity for use in gastrointestinal sutures. The envelope is accompanied by magnetic strips (12), which help in organizing the needles (8). The set also has a template box (3) with a rigid structure, where the needles (8) are placed after they are used. This template (3) serves to assist the scrub nurse in counting to ensure that all pieces have been collected after the procedure is finished.

[0052] Examples of implementations of the utility model

[0053]

[0038] An example of a model is “PASSBY V” (three-dimensional device for vascular or cardiovascular anastomosis), exemplified by figures 7 and 13. This model is composed of a polypropylene ring (7) that can vary in diameter, with variable thicknesses as well. It is assembled with at least 4 polypropylene sutures (6), which can also vary in length and thickness. It is used in pairs (one for each anastomotic opening) and is used externally to the vessels (10). In positioning the device, the needled threads (6 and 9) are inserted from the adventitia to the endothelium, in opposite positions, favoring eversion and excellent exposure of the edges. Positioning a ring (7) at each vascular edge allows anastomosis to be performed in two openings of identical diameters, well-structured, open and with suture threads (6 and 9) symmetrically distributed throughout the circumference.The alignment of the suture threads (6 and 9) in cardinal positions is what allows for the rapid structuring and calibration of the anastomosis, enabling the procedure to be performed quickly and accurately. The needles (8) are organized with the aid of magnetic strips (12). The drawings and description provided do not limit the composition of other models not described in this text.

[0054]

[0039] Another model of this invention is the “PASSBY gastrointestinal”, which can be exemplified by figures 12 and 14. This model is formed by a central ring (7) of absorbable suture (polydioxanone, for example), with various diameters and thicknesses (thickness 0, with 2.5 or 3 centimeters in diameter, for example). It is assembled with 2, 3, 4 or 5 barbed suture threads (9), which also vary in material (polydioxanone, for example), lengths (10 centimeters, for example) and thicknesses (3.0, for example). It is generally used in only one of the two anastomotic openings. It can be used both to anastomose and to close the hole left by the mechanical suture. The fact that it is used with barbed suture (9) allows that no knots are used. For its use, the needles (8) are initially inserted from the mucosa towards the serosa of the edge to be sutured, distributing the sutures (6 and 9) in opposite positions (“cardinal points”).A new needle pass (8) from the mucosa to the serosa stabilizes the device while inverting the edges of the mucosa. The needles (8) are organized with the help of magnetic strips (12). From there, the anastomosis proceeds as usual, but with more than one suture (6 and 9) prepared, making it easier and faster. The drawings and description provided do not limit the composition of other models not described in this text.

[0055]

[0040] Another example of this device is the “PASSBY P”, a three-dimensional annular suture device for pancreaticojejunal anastomosis suture, which can be illustrated by figures 8 and 15. The device consists of an absorbable ring (7) (polydioxanone, for example), which can be made in various diameters and thicknesses (2.0 mm thick with a 5 mm diameter, for example), containing multiple absorbable suture threads (6 and 9) (8 needled threads, for example). The diameter of the ring (7) defines the size of the anastomosis, calibrating the opening of the jejunum (10) with the diameter of the pancreatic duct (11). In this way, it results in better apposition of the jejunal mucosa with the walls of the pancreatic duct (11). It functions as a framework for invagination of the jejunal mucosa, positions and supports the suture threads (6 and 9), facilitating the passage of the needles (8) at the anastomotic edges, both of the jejunum (10) and of the pancreatic duct (11).The device placement begins with passing the needles (8) from the mucosa to the serosa at the jejunal opening (10), at opposite points (“cardinal points”). A further passage of the needles (8) from the mucosa to the serosa helps in inverting the edges of the jejunal mucosa. From here, the sutures (6 and 9) are applied one by one to the pancreatic duct (11) as in the conventional manner. The needles (8) are arranged with the aid of a magnetic strip in a “U” shape (12).

Claims

CLAIMS 1. THREE-DIMENSIONAL ANNULAR SUTURE DEVICE FOR VASCULAR AND GASTROINTESTINAL ANASTOMOSES, comprising a ring-shaped framework (7), assembled with needled suture threads (6, 9), including auxiliary control and organization elements, being a collection template (3), magnetized receptacles (4), metallic storage locations (5) and magnetic strips (12), characterized by the arrangement of the needled suture threads (6, 9) in opposite positions in the non-absorbable or absorbable ring (7), allowing three-dimensional anastomosis, with needles (8) structured for passage in a predefined direction and stabilization of the device before performing the suture.

2. THREE-DIMENSIONAL ANNULAR SUTURE DEVICE FOR VASCULAR AND GASTROINTESTINAL ANASTOMOSES, according to claim 1, characterized by having 1 to 12 needled suture threads (6, 9), with variable lengths preferably of 10 cm and variable thicknesses preferably of 3 mm.

3. THREE-DIMENSIONAL ANNULAR SUTURE DEVICE FOR VASCULAR ANASTOMOSES of claim 1, characterized by being manufactured with non-absorbable monofilament material, comprising a polypropylene or polyethylene ring (7) and needled suture threads (6) arranged radially and crosswise for eversion of the anastomotic edges.

4. THREE-DIMENSIONAL ANNULAR SUTURE DEVICE FOR VASCULAR ANASTOMOSES, according to claim 3, characterized by having a set of needled suture threads (6) arranged symmetrically and distributed in cardinal positions of the ring (7), allowing calibration of the anastomotic openings of identical diameter.

5. THREE-DIMENSIONAL ANNULAR SUTURE DEVICE FOR GASTROINTESTINAL ANASTOMOSES of claim 1, characterized by being manufactured with absorbable monofilament material, comprising a ring (7) of polydioxanone and barbed suture threads (9) positioned internally to the circular structure of the device.

6. THREE-DIMENSIONAL RING SUTURE DEVICE FOR GASTROINTESTINAL ANASTOMOSES, according to claim 5, characterized by having a polydioxanone ring (7), with barbed suture threads (9) fixed to needles (8) and mounted in opposite positions, allowing insertion from the mucosa to the serosa.

7. COLLECTION BOX FOR MATERIALS USED IN SURGICAL PROCEDURES, comprising a collection template (3), characterized by containing magnetized receptacles (4) for orderly arrangement of needles (8) and metal locations (5) for storing magnetic strips (12).

8. ORGANIZING STRIPS FOR NEEDLES IN THE OPERATING FIELD, characterized by comprising magnetic strips (12) with a modular and adjustable arrangement for laparoscopic or open procedures.

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